https://www.510kdatabase.net/k260018/ 2026-06-26 monthly 0.8 https://www.510kdatabase.net/og-image/k260018-arthrex-fiberbutton-fda-510k.jpg K260018 - Arthrex FiberButton K260018 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jun 2026. https://www.510kdatabase.net/k253330/ 2026-06-25 monthly 0.8 https://www.510kdatabase.net/og-image/k253330-a5-anesthesia-system-a5-fda-510k.jpg K253330 - A5 Anesthesia System (A5) K253330 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Jun 2026. https://www.510kdatabase.net/k253394/ 2026-06-25 monthly 0.8 https://www.510kdatabase.net/og-image/k253394-coated-vicryl-polyglactin-910-plus-fda-510k.jpg K253394 - Coated VICRYL™ (Polyglactin 910) Plus Antibacterial Suture K253394 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Jun 2026. https://www.510kdatabase.net/k253786/ 2026-06-25 monthly 0.8 https://www.510kdatabase.net/og-image/k253786-syngoct-coronary-cockpit-fda-510k.jpg K253786 - syngo.CT Coronary Cockpit K253786 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 2026. https://www.510kdatabase.net/k260809/ 2026-06-25 monthly 0.8 https://www.510kdatabase.net/og-image/k260809-arthrex-sterile-val-and-val-kreulock-fda-510k.jpg K260809 - Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System K260809 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jun 2026. https://www.510kdatabase.net/k261055/ 2026-06-24 monthly 0.8 https://www.510kdatabase.net/og-image/k261055-amsco-700-steam-sterilizer-fda-510k.jpg K261055 - AMSCO 700 Steam Sterilizer K261055 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Jun 2026. https://www.510kdatabase.net/k261866/ 2026-06-24 monthly 0.8 https://www.510kdatabase.net/og-image/k261866-concerto-versa-detachable-coil-fda-510k.jpg K261866 - Concerto Versa™ Detachable Coil K261866 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Jun 2026. https://www.510kdatabase.net/k253678/ 2026-06-18 monthly 0.8 https://www.510kdatabase.net/og-image/k253678-mammomat-bbrilliant-11372950-fda-510k.jpg K253678 - MAMMOMAT B.brilliant (11372950) K253678 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 2026. https://www.510kdatabase.net/k260428/ 2026-06-17 monthly 0.8 https://www.510kdatabase.net/og-image/k260428-rivos-eus-access-device-m00553900-fda-510k.jpg K260428 - RIVOS™ EUS Access Device (M00553900) K260428 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Jun 2026. https://www.510kdatabase.net/k260831/ 2026-06-16 monthly 0.8 https://www.510kdatabase.net/og-image/k260831-z1-hip-system-fda-510k.jpg K260831 - Z1 Hip System K260831 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jun 2026. https://www.510kdatabase.net/k260844/ 2026-06-16 monthly 0.8 https://www.510kdatabase.net/og-image/k260844-acuson-sequoia-diagnostic-ultrasound-fda-510k.jpg K260844 - ACUSON Sequoia Diagnostic Ultrasound System K260844 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 2026. https://www.510kdatabase.net/k261683/ 2026-06-16 monthly 0.8 https://www.510kdatabase.net/og-image/k261683-augment-off-axis-instrument-system-fda-510k.jpg K261683 - Augment Off-Axis Instrument System K261683 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jun 2026. https://www.510kdatabase.net/k252323/ 2026-06-12 monthly 0.8 https://www.510kdatabase.net/og-image/k252323-cobas-pulse-blood-glucose-monitoring-fda-510k.jpg K252323 - cobas pulse blood glucose monitoring system K252323 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Jun 2026. https://www.510kdatabase.net/k251326/ 2026-06-11 monthly 0.8 https://www.510kdatabase.net/og-image/k251326-respiration-rate-algorithm-fda-510k.jpg K251326 - Respiration Rate algorithm K251326 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Jun 2026. https://www.510kdatabase.net/k243192/ 2026-06-05 monthly 0.8 https://www.510kdatabase.net/og-image/k243192-insitu-lateralized-acetabular-liners-fda-510k.jpg K243192 - iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi Coating K243192 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nextstep Arthopedix, LLC. Cleared Jun 2026. https://www.510kdatabase.net/k251684/ 2026-06-05 monthly 0.8 https://www.510kdatabase.net/og-image/k251684-alma-ted-system-fda-510k.jpg K251684 - Alma TED+ System K251684 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Alma Lasers, Inc.. Cleared Jun 2026. https://www.510kdatabase.net/k253108/ 2026-06-05 monthly 0.8 https://www.510kdatabase.net/og-image/k253108-veofix-snap-off-screw-fda-510k.jpg K253108 - VEOFIX Snap Off Screw K253108 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Steps Ortho. Cleared Jun 2026. https://www.510kdatabase.net/k253162/ 2026-06-05 monthly 0.8 https://www.510kdatabase.net/og-image/k253162-temperature-probes-t2252-pg-fda-510k.jpg K253162 - Temperature probes (T2252-PG) K253162 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Unimed Medical Supplies, Inc.. Cleared Jun 2026. https://www.510kdatabase.net/k253204/ 2026-06-05 monthly 0.8 https://www.510kdatabase.net/og-image/k253204-catalyze-fda-510k.jpg K253204 - Catalyze K253204 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: BioTissue Holdings, Inc.. Cleared Jun 2026. https://www.510kdatabase.net/k253296/ 2026-06-05 monthly 0.8 https://www.510kdatabase.net/og-image/k253296-digital-c-arm-with-3d-fda-510k.jpg K253296 - Digital C-ARM with 3D K253296 is a FDA 510(k) cleared radiology medical device. Manufacturer: Allengers Medical Systems Limited. Cleared Jun 2026. https://www.510kdatabase.net/k253656/ 2026-06-05 monthly 0.8 https://www.510kdatabase.net/og-image/k253656-osteocool-rf-ablation-system-fda-510k.jpg K253656 - OsteoCool™ RF Ablation System K253656 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Jun 2026. https://www.510kdatabase.net/k254086/ 2026-06-05 monthly 0.8 https://www.510kdatabase.net/og-image/k254086-eyebox-snap-fda-510k.jpg K254086 - EyeBOX SNAP K254086 is a FDA 510(k) cleared neurology medical device. Manufacturer: Oculogica, Inc.. Cleared Jun 2026. https://www.510kdatabase.net/k260056/ 2026-06-05 monthly 0.8 https://www.510kdatabase.net/og-image/k260056-power-wheelchair-n5515a-n5516-n5517a-fda-510k.jpg K260056 - Power Wheelchair (N5515A, N5516, N5517A, N5519) K260056 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zhejiang Innuovo Rehabilitation Devices Co.,Ltd. Cleared Jun 2026. https://www.510kdatabase.net/k260105/ 2026-06-05 monthly 0.8 https://www.510kdatabase.net/og-image/k260105-fogarty-spring-clips-handleless-clamps-fda-510k.jpg K260105 - Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts K260105 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences. Cleared Jun 2026. https://www.510kdatabase.net/k260289/ 2026-06-05 monthly 0.8 https://www.510kdatabase.net/og-image/k260289-perfect-o-ostial-positioning-catheter-fda-510k.jpg K260289 - Perfect-O Ostial Positioning Catheter K260289 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Balosmark, Inc.. Cleared Jun 2026. https://www.510kdatabase.net/k260301/ 2026-06-05 monthly 0.8 https://www.510kdatabase.net/og-image/k260301-vial-adapter-fda-510k.jpg K260301 - Vial Adapter K260301 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hangzhou Qiantang Longyue Biotechnology Co., Ltd.. Cleared Jun 2026. https://www.510kdatabase.net/k260754/ 2026-06-05 monthly 0.8 https://www.510kdatabase.net/og-image/k260754-fastep-covid-19-antigen-pen-home-test-fda-510k.jpg K260754 - Fastep COVID-19 Antigen Pen Home Test K260754 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Assure Tech., LLC. Cleared Jun 2026. https://www.510kdatabase.net/k260761/ 2026-06-05 monthly 0.8 https://www.510kdatabase.net/og-image/k260761-aptus-clavicle-system-28-fda-510k.jpg K260761 - APTUS Clavicle System 2.8 K260761 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medartis AG. Cleared Jun 2026. https://www.510kdatabase.net/k261492/ 2026-06-05 monthly 0.8 https://www.510kdatabase.net/og-image/k261492-fieldflex-steerable-sheath-fda-510k.jpg K261492 - FieldFlex Steerable Sheath K261492 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: CenterPoint Systems, LLC. Cleared Jun 2026. https://www.510kdatabase.net/k252575/ 2026-06-04 monthly 0.8 https://www.510kdatabase.net/og-image/k252575-tuff-cuff-disposable-surgical-gowns-fda-510k.jpg K252575 - Tuff Cuff™ Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L) K252575 is a FDA 510(k) cleared general hospital medical device. Manufacturer: New York Embroidery Studio (NYES). Cleared Jun 2026. https://www.510kdatabase.net/k253004/ 2026-06-04 monthly 0.8 https://www.510kdatabase.net/og-image/k253004-luna-3d-fda-510k.jpg K253004 - LUNA 3D K253004 is a FDA 510(k) cleared radiology medical device. Manufacturer: Lap GmbH Laser Applikationen. Cleared Jun 2026. https://www.510kdatabase.net/k253020/ 2026-06-04 monthly 0.8 https://www.510kdatabase.net/og-image/k253020-strauss-surgical-resection-instruments-fda-510k.jpg K253020 - Strauss Surgical Resection Instruments K253020 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: American Medical Endoscopy, Inc.. Cleared Jun 2026. https://www.510kdatabase.net/k253026/ 2026-06-04 monthly 0.8 https://www.510kdatabase.net/og-image/k253026-respiratory-gating-for-scanners-21-fda-510k.jpg K253026 - Respiratory Gating for Scanners (2.1) K253026 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Jun 2026. https://www.510kdatabase.net/k253102/ 2026-06-04 monthly 0.8 https://www.510kdatabase.net/og-image/k253102-gt-metabolic-magdi-system-mag-01-mag-fda-510k.jpg K253102 - GT Metabolic MagDI System (MAG-01, MAG-02, DS-01) K253102 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Gt Metabolic Solutions, Inc.. Cleared Jun 2026. https://www.510kdatabase.net/k253553/ 2026-06-04 monthly 0.8 https://www.510kdatabase.net/og-image/k253553-orion-fda-510k.jpg K253553 - Orion K253553 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: ResMed Corp. Cleared Jun 2026. https://www.510kdatabase.net/k253602/ 2026-06-04 monthly 0.8 https://www.510kdatabase.net/og-image/k253602-precision-s-4k-sinuscope-fda-510k.jpg K253602 - Precision S 4K Sinuscope K253602 is a FDA 510(k) cleared neurology medical device. Manufacturer: Stryker Endoscopy. Cleared Jun 2026. https://www.510kdatabase.net/k253893/ 2026-06-04 monthly 0.8 https://www.510kdatabase.net/og-image/k253893-harmony-referral-system-with-harmony-fda-510k.jpg K253893 - Harmony Referral System with Harmony OCT Viewer (Octave) K253893 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Topcon Healthcare Solutions EMEA Oy. Cleared Jun 2026. https://www.510kdatabase.net/k253984/ 2026-06-04 monthly 0.8 https://www.510kdatabase.net/og-image/k253984-instrument-exit-point-on-touch-surgery-fda-510k.jpg K253984 - Instrument Exit Point on Touch Surgery™ Aide K253984 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien, LLC. Cleared Jun 2026. https://www.510kdatabase.net/k253994/ 2026-06-04 monthly 0.8 https://www.510kdatabase.net/og-image/k253994-trokit-laparoscope-lens-wiper-fda-510k.jpg K253994 - TroKit Laparoscope Lens Wiper K253994 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: TroCare, LLC. Cleared Jun 2026. https://www.510kdatabase.net/k254209/ 2026-06-04 monthly 0.8 https://www.510kdatabase.net/og-image/k254209-radius-vsm-and-accessories-fda-510k.jpg K254209 - Radius VSM and Accessories K254209 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Masimo Corporation. Cleared Jun 2026. https://www.510kdatabase.net/k260497/ 2026-06-04 monthly 0.8 https://www.510kdatabase.net/og-image/k260497-deepvessel-plaque-fda-510k.jpg K260497 - DEEPVESSEL Plaque K260497 is a FDA 510(k) cleared radiology medical device. Manufacturer: Keya Medical Technology Co., Ltd.. Cleared Jun 2026. https://www.510kdatabase.net/k260662/ 2026-06-04 monthly 0.8 https://www.510kdatabase.net/og-image/k260662-dental-cone-beam-computed-tomography-fda-510k.jpg K260662 - Dental Cone Beam Computed Tomography System K260662 is a FDA 510(k) cleared radiology medical device. Manufacturer: Yofo Medical Technology Co., Ltd.. Cleared Jun 2026. https://www.510kdatabase.net/k260690/ 2026-06-04 monthly 0.8 https://www.510kdatabase.net/og-image/k260690-lumiglam-laser-system-she-lsp601-3-fda-510k.jpg K260690 - LumiGlam Laser System (SHE-LSP601-3) K260690 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Beijing Sano Laser S&T Development Co.,Ltd. Cleared Jun 2026. https://www.510kdatabase.net/k260770/ 2026-06-04 monthly 0.8 https://www.510kdatabase.net/og-image/k260770-liaison-murex-hbsag-qual-fda-510k.jpg K260770 - LIAISON Murex HBsAg Qual K260770 is a FDA 510(k) cleared microbiology medical device. Manufacturer: DiaSorin, Inc.. Cleared Jun 2026. https://www.510kdatabase.net/k260956/ 2026-06-04 monthly 0.8 https://www.510kdatabase.net/og-image/k260956-spectra-platinum-mini-fda-510k.jpg K260956 - Spectra Platinum Mini K260956 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Uzinmedicare Co., Ltd.. Cleared Jun 2026. https://www.510kdatabase.net/k261510/ 2026-06-04 monthly 0.8 https://www.510kdatabase.net/og-image/k261510-signature-one-system-fda-510k.jpg K261510 - Signature™ ONE System K261510 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthosoft Inc. (d/b/a) Zimmer CAS. Cleared Jun 2026. https://www.510kdatabase.net/k261519/ 2026-06-04 monthly 0.8 https://www.510kdatabase.net/og-image/k261519-sonio-suspect-fda-510k.jpg K261519 - Sonio Suspect K261519 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sonio. Cleared Jun 2026. https://www.510kdatabase.net/k252800/ 2026-06-03 monthly 0.8 https://www.510kdatabase.net/og-image/k252800-karl-storz-endoscopic-accessories-for-fda-510k.jpg K252800 - KARL STORZ Endoscopic Accessories for Urology K252800 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Karl Storz SE & CO. KG. Cleared Jun 2026. https://www.510kdatabase.net/k252854/ 2026-06-03 monthly 0.8 https://www.510kdatabase.net/og-image/k252854-steritite-container-system-with-fda-510k.jpg K252854 - SteriTite Container System with MediTray Products K252854 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Case Medical, Inc.. Cleared Jun 2026. https://www.510kdatabase.net/k252904/ 2026-06-03 monthly 0.8 https://www.510kdatabase.net/og-image/k252904-sic-abutments-including-cadcam-solutions-fda-510k.jpg K252904 - SIC Abutments including CAD/CAM Solutions K252904 is a FDA 510(k) cleared dental medical device. Manufacturer: Sic Invent AG. Cleared Jun 2026. https://www.510kdatabase.net/k253124/ 2026-06-03 monthly 0.8 https://www.510kdatabase.net/og-image/k253124-upper-arm-electronic-blood-pressure-fda-510k.jpg K253124 - Upper arm electronic blood pressure monitor (XB-01) K253124 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Ziqing Medical Equipment Co., Ltd.. Cleared Jun 2026. https://www.510kdatabase.net/k253600/ 2026-06-03 monthly 0.8 https://www.510kdatabase.net/og-image/k253600-scooter-yd-03-fda-510k.jpg K253600 - Scooter (YD-03) K253600 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Yurob Rehabilitation Medical Co., Ltd.. Cleared Jun 2026. https://www.510kdatabase.net/k253974/ 2026-06-03 monthly 0.8 https://www.510kdatabase.net/og-image/k253974-roosin-collagen-dressing-fda-510k.jpg K253974 - Roosin Collagen Dressing K253974 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Roosin Medical Co., Ltd.. Cleared Jun 2026. https://www.510kdatabase.net/k254034/ 2026-06-03 monthly 0.8 https://www.510kdatabase.net/og-image/k254034-roosin-collagen-powder-fda-510k.jpg K254034 - Roosin Collagen Powder K254034 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Roosin Medical Co., Ltd.. Cleared Jun 2026. https://www.510kdatabase.net/k260116/ 2026-06-03 monthly 0.8 https://www.510kdatabase.net/og-image/k260116-customed-viewer-fda-510k.jpg K260116 - CustoMED Viewer K260116 is a FDA 510(k) cleared radiology medical device. Manufacturer: CustoMED , Ltd.. Cleared Jun 2026. https://www.510kdatabase.net/k260179/ 2026-06-03 monthly 0.8 https://www.510kdatabase.net/og-image/k260179-vitamulti-functionheadbrush-tb-2343f-fda-510k.jpg K260179 - VITA Multi-Function Head Brush (TB-2343F, TB-2442F) K260179 is a FDA 510(k) cleared neurology medical device. Manufacturer: Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.. Cleared Jun 2026. https://www.510kdatabase.net/k260373/ 2026-06-03 monthly 0.8 https://www.510kdatabase.net/og-image/k260373-electric-wheelchair-df506-fda-510k.jpg K260373 - Electric Wheelchair (DF506) K260373 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Jiangsu Yveelt Medical Equipment Co., Ltd.. Cleared Jun 2026. https://www.510kdatabase.net/k260402/ 2026-06-03 monthly 0.8 https://www.510kdatabase.net/og-image/k260402-mert-system-fda-510k.jpg K260402 - MeRT System K260402 is a FDA 510(k) cleared neurology medical device. Manufacturer: Wave Neuroscience. Cleared Jun 2026. https://www.510kdatabase.net/k260703/ 2026-06-03 monthly 0.8 https://www.510kdatabase.net/og-image/k260703-powder-free-blue-nitrile-examination-fda-510k.jpg K260703 - Powder Free Blue Nitrile Examination Glove - Tested for Use with Chemotherapy Drugs and Fentanyl K260703 is a FDA 510(k) cleared general hospital medical device. Manufacturer: S&S Glove Corporation. Cleared Jun 2026. https://www.510kdatabase.net/k260715/ 2026-06-03 monthly 0.8 https://www.510kdatabase.net/og-image/k260715-currentbody-skin-led-multi-light-fda-510k.jpg K260715 - CurrentBody Skin LED Multi Light Therapy Mask (MK-110D) K260715 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: The Beauty Tech Group, Ltd.. Cleared Jun 2026. https://www.510kdatabase.net/k260726/ 2026-06-03 monthly 0.8 https://www.510kdatabase.net/og-image/k260726-straumann-proclean-cassette-041800-fda-510k.jpg K260726 - Straumann® ProClean™ Cassette (041.800 K260726 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Institut Straumann AG. Cleared Jun 2026. https://www.510kdatabase.net/k260780/ 2026-06-03 monthly 0.8 https://www.510kdatabase.net/og-image/k260780-heartfocus-fda-510k.jpg K260780 - HeartFocus K260780 is a FDA 510(k) cleared radiology medical device. Manufacturer: Deski. Cleared Jun 2026. https://www.510kdatabase.net/k260806/ 2026-06-03 monthly 0.8 https://www.510kdatabase.net/og-image/k260806-nitrile-disposable-examination-gloves-fda-510k.jpg K260806 - Nitrile Disposable Examination Gloves K260806 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Vista Industries,, LLC. Cleared Jun 2026. https://www.510kdatabase.net/k261439/ 2026-06-03 monthly 0.8 https://www.510kdatabase.net/og-image/k261439-permatage-flowable-settable-hemostatic-fda-510k.jpg K261439 - Permatage Flowable, Settable Hemostatic Bone Paste K261439 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthocon, Inc.. Cleared Jun 2026. https://www.510kdatabase.net/k261484/ 2026-06-03 monthly 0.8 https://www.510kdatabase.net/og-image/k261484-tissue-approximation-system-fda-510k.jpg K261484 - Tissue Approximation System K261484 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Tas Medical, Inc.. Cleared Jun 2026. https://www.510kdatabase.net/k261522/ 2026-06-03 monthly 0.8 https://www.510kdatabase.net/og-image/k261522-biowave-biowraps-fda-510k.jpg K261522 - BioWave BioWraps K261522 is a FDA 510(k) cleared neurology medical device. Manufacturer: Biowave Corporation. Cleared Jun 2026. https://www.510kdatabase.net/k261530/ 2026-06-03 monthly 0.8 https://www.510kdatabase.net/og-image/k261530-iisure-infusion-set-fda-510k.jpg K261530 - iiSure Infusion Set K261530 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Deka Research and Development. Cleared Jun 2026. https://www.510kdatabase.net/k261826/ 2026-06-03 monthly 0.8 https://www.510kdatabase.net/og-image/k261826-vsp-system-titanium-palatal-splint-fda-510k.jpg K261826 - VSP System (Titanium Palatal Splint) K261826 is a FDA 510(k) cleared dental medical device. Manufacturer: 3D Systems, Inc.. Cleared Jun 2026. https://www.510kdatabase.net/k261840/ 2026-06-03 monthly 0.8 https://www.510kdatabase.net/og-image/k261840-bracepaste-prime-plus-fda-510k.jpg K261840 - BracePaste Prime Plus K261840 is a FDA 510(k) cleared dental medical device. Manufacturer: American Orthodontics. Cleared Jun 2026. https://www.510kdatabase.net/k252532/ 2026-06-02 monthly 0.8 https://www.510kdatabase.net/og-image/k252532-inno-port-disposable-bladed-trocar-fda-510k.jpg K252532 - Inno-Port Disposable Bladed Trocar K252532 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Taiwan Surgical Corporation. Cleared Jun 2026. https://www.510kdatabase.net/k252816/ 2026-06-02 monthly 0.8 https://www.510kdatabase.net/og-image/k252816-high-tone-power-therapy-hitop-model-fda-510k.jpg K252816 - High Tone Power therapy (HiToP) (Model: HiToP PNP) K252816 is a FDA 510(k) cleared neurology medical device. Manufacturer: Mohammadali Nezakati. Cleared Jun 2026. https://www.510kdatabase.net/k252844/ 2026-06-02 monthly 0.8 https://www.510kdatabase.net/og-image/k252844-tyto-insights-for-wheeze-detection-fda-510k.jpg K252844 - Tyto Insights for Wheeze Detection (with PCCP) K252844 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Tyto Care , Ltd.. Cleared Jun 2026. https://www.510kdatabase.net/k252899/ 2026-06-02 monthly 0.8 https://www.510kdatabase.net/og-image/k252899-female-culture-device-fda-510k.jpg K252899 - Female Culture Device K252899 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zhejiang Kindly Medical Device Co., Ltd.. Cleared Jun 2026. https://www.510kdatabase.net/k253195/ 2026-06-02 monthly 0.8 https://www.510kdatabase.net/og-image/k253195-taurus-posterior-occipital-cervico-fda-510k.jpg K253195 - TAURUS Posterior Occipital-Cervico-Thoracic Spinal Systems K253195 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: ZheJiang Decans Medical Devices Co., Ltd.. Cleared Jun 2026. https://www.510kdatabase.net/k253302/ 2026-06-02 monthly 0.8 https://www.510kdatabase.net/og-image/k253302-hemospray-endoscopic-hemostat-hemo-x-fda-510k.jpg K253302 - Hemospray Endoscopic Hemostat (HEMO-[X]) K253302 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wilson-Cook Medical, Inc.. Cleared Jun 2026. https://www.510kdatabase.net/k253507/ 2026-06-02 monthly 0.8 https://www.510kdatabase.net/og-image/k253507-packaged-assembly-reusable-navigation-fda-510k.jpg K253507 - Packaged Assembly, Reusable Navigation Unit K253507 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthalign, Inc.. Cleared Jun 2026. https://www.510kdatabase.net/k253803/ 2026-06-02 monthly 0.8 https://www.510kdatabase.net/og-image/k253803-milan-system-fda-510k.jpg K253803 - MILAN System K253803 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lumenis Be, Ltd.. Cleared Jun 2026. https://www.510kdatabase.net/k253918/ 2026-06-02 monthly 0.8 https://www.510kdatabase.net/og-image/k253918-veineo-system-00medrf4000tcus-05cr45it-fda-510k.jpg K253918 - Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) K253918 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: F Care Systems USA, LLC. Cleared Jun 2026. https://www.510kdatabase.net/k260270/ 2026-06-02 monthly 0.8 https://www.510kdatabase.net/og-image/k260270-findair-one-for-pmdi-fao-mdi-v12-gre-001-fda-510k.jpg K260270 - FindAir ONE for pMDI (FAO-MDI-V12-GRE-001) K260270 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: FindAir Sp. z o.o.. Cleared Jun 2026. https://www.510kdatabase.net/k260364/ 2026-06-02 monthly 0.8 https://www.510kdatabase.net/og-image/k260364-device-300419-strip-fda-510k.jpg K260364 - Device 300419 Strip K260364 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Geistlich Pharma AG. Cleared Jun 2026. https://www.510kdatabase.net/k260569/ 2026-06-02 monthly 0.8 https://www.510kdatabase.net/og-image/k260569-db-4000-high-impact-denture-base-fda-510k.jpg K260569 - DB 4000 High Impact Denture Base K260569 is a FDA 510(k) cleared dental medical device. Manufacturer: Carbon, Inc.. Cleared Jun 2026. https://www.510kdatabase.net/k260571/ 2026-06-02 monthly 0.8 https://www.510kdatabase.net/og-image/k260571-simpact-sacroiliac-joint-fixation-fda-510k.jpg K260571 - SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments K260571 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Jun 2026. https://www.510kdatabase.net/k260642/ 2026-06-02 monthly 0.8 https://www.510kdatabase.net/og-image/k260642-manual-wheelchair-lw01108-fda-510k.jpg K260642 - Manual Wheelchair (LW01108) K260642 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Anhui Longway Medical Technology Co., Ltd.. Cleared Jun 2026. https://www.510kdatabase.net/k261002/ 2026-06-02 monthly 0.8 https://www.510kdatabase.net/og-image/k261002-pectus-blu-system-fda-510k.jpg K261002 - Pectus Blu System K261002 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet Microfixation. Cleared Jun 2026. https://www.510kdatabase.net/k261093/ 2026-06-02 monthly 0.8 https://www.510kdatabase.net/og-image/k261093-diafil-fda-510k.jpg K261093 - DIAFIL K261093 is a FDA 510(k) cleared dental medical device. Manufacturer: DiaDent Group International. Cleared Jun 2026. https://www.510kdatabase.net/k261540/ 2026-06-02 monthly 0.8 https://www.510kdatabase.net/og-image/k261540-cube-4d-navigation-system-virtueye-pro-fda-510k.jpg K261540 - Cube 4D Navigation System, VirtuEye Pro K261540 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Fiagon GmbH. Cleared Jun 2026. https://www.510kdatabase.net/k253882/ 2026-06-01 monthly 0.8 https://www.510kdatabase.net/og-image/k253882-cordx-tyfast-covid-19-ag-rapid-test-rx-fda-510k.jpg K253882 - CorDx Tyfast COVID-19 Ag Rapid Test Rx K253882 is a FDA 510(k) cleared microbiology medical device. Manufacturer: CorDx, Inc.. Cleared Jun 2026. https://www.510kdatabase.net/k260456/ 2026-06-01 monthly 0.8 https://www.510kdatabase.net/og-image/k260456-viport-liver-preservation-system-fda-510k.jpg K260456 - VI°Port™ Liver Preservation System K260456 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Traferox Technologies, Inc.. Cleared Jun 2026. https://www.510kdatabase.net/k261541/ 2026-06-01 monthly 0.8 https://www.510kdatabase.net/og-image/k261541-visionair-enhanced-stock-stent-fda-510k.jpg K261541 - VisionAir Enhanced Stock Stent K261541 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: VisionAir Solutions. Cleared Jun 2026. https://www.510kdatabase.net/k261154/ 2026-05-30 monthly 0.8 https://www.510kdatabase.net/og-image/k261154-colink-colag-non-sterile-screws-fda-510k.jpg K261154 - CoLink® & CoLag® Non-Sterile Screws K261154 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: In2bones USA, LLC. Cleared May 2026. https://www.510kdatabase.net/k252396/ 2026-05-29 monthly 0.8 https://www.510kdatabase.net/og-image/k252396-cryo-sport-20-ava-501-fda-510k.jpg K252396 - Cryo Sport 2.0 (AVA 501) K252396 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Avanutri Equipamentos DE Saúde. Cleared May 2026. https://www.510kdatabase.net/k252802/ 2026-05-29 monthly 0.8 https://www.510kdatabase.net/og-image/k252802-peak-flow-meter-pf-10br-pef231-fda-510k.jpg K252802 - Peak Flow Meter (PF-10(BR-PEF231)) K252802 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Bi-Rich Medical Devices Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k252821/ 2026-05-29 monthly 0.8 https://www.510kdatabase.net/og-image/k252821-reusable-adult-spo2-clip-sensor-3m-fda-510k.jpg K252821 - Reusable Adult SpO2 Clip Sensor (3m) (M1196A) K252821 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Philips Medizin Systeme B?blingen GmbH. Cleared May 2026. https://www.510kdatabase.net/k252840/ 2026-05-29 monthly 0.8 https://www.510kdatabase.net/og-image/k252840-m12-telemetry-system-fda-510k.jpg K252840 - M12 Telemetry System K252840 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Global Instrumentation, LLC. Cleared May 2026. https://www.510kdatabase.net/k252859/ 2026-05-29 monthly 0.8 https://www.510kdatabase.net/og-image/k252859-zeus-platform-fg0501us-fda-510k.jpg K252859 - ZEUS Platform (FG0501US) K252859 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: iRhythm Technologies, Inc.. Cleared May 2026. https://www.510kdatabase.net/k252947/ 2026-05-29 monthly 0.8 https://www.510kdatabase.net/og-image/k252947-histosonics-planning-tool-fda-510k.jpg K252947 - HistoSonics® Planning Tool K252947 is a FDA 510(k) cleared radiology medical device. Manufacturer: HistoSonics, Inc.. Cleared May 2026. https://www.510kdatabase.net/k252965/ 2026-05-29 monthly 0.8 https://www.510kdatabase.net/og-image/k252965-oxygen-concentrator-ox-5a-ox-5c-fda-510k.jpg K252965 - Oxygen Concentrator (OX-5A, OX-5C) K252965 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Oxytek Medical Technology Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k253103/ 2026-05-29 monthly 0.8 https://www.510kdatabase.net/og-image/k253103-nexus-drf-digital-x-ray-imaging-system-fda-510k.jpg K253103 - Nexus DRF Digital X-ray Imaging System K253103 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varex Imaging Corporation. Cleared May 2026. https://www.510kdatabase.net/k253119/ 2026-05-29 monthly 0.8 https://www.510kdatabase.net/og-image/k253119-cosense-etco-monitor-fda-510k.jpg K253119 - CoSense ETCO Monitor K253119 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Capnia, Inc.. Cleared May 2026. https://www.510kdatabase.net/k254076/ 2026-05-29 monthly 0.8 https://www.510kdatabase.net/og-image/k254076-bd-touchless-plus-unisex-pre-fda-510k.jpg K254076 - BD Touchless™ Plus Unisex Pre-Lubricated Urethral Catheter Kit K254076 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 2026. https://www.510kdatabase.net/k254300/ 2026-05-29 monthly 0.8 https://www.510kdatabase.net/og-image/k254300-eufy-wearable-breast-pump-t600p-t6000-fda-510k.jpg K254300 - eufy Wearable Breast Pump (T600P, T6000, T6001, T6002, T6003, T6004, T6005, T6006, T6007, T6008, T6009) K254300 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Anker Innovations Limited. Cleared May 2026. https://www.510kdatabase.net/k260077/ 2026-05-29 monthly 0.8 https://www.510kdatabase.net/og-image/k260077-orthogrid-hip-ai-40-fda-510k.jpg K260077 - OrthoGrid Hip AI® 4.0 K260077 is a FDA 510(k) cleared radiology medical device. Manufacturer: OrthoGrid Systems, Inc.. Cleared May 2026. https://www.510kdatabase.net/k260138/ 2026-05-29 monthly 0.8 https://www.510kdatabase.net/og-image/k260138-lune-purehygiene-fda-510k.jpg K260138 - LUNE PureHygiene K260138 is a FDA 510(k) cleared dental medical device. Manufacturer: Enamel Pure. Cleared May 2026. https://www.510kdatabase.net/k260262/ 2026-05-29 monthly 0.8 https://www.510kdatabase.net/og-image/k260262-injection-needle-fda-510k.jpg K260262 - Injection Needle K260262 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Mirco-Tech (Nanjing) Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k260489/ 2026-05-29 monthly 0.8 https://www.510kdatabase.net/og-image/k260489-lasemar-1500-fda-510k.jpg K260489 - LASEmaR 1500 K260489 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Eufoton S.R.L.. Cleared May 2026. https://www.510kdatabase.net/k260507/ 2026-05-29 monthly 0.8 https://www.510kdatabase.net/og-image/k260507-interojo-45-inofilcon-a-soft-fda-510k.jpg K260507 - Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus K260507 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: INTEROJO, Inc.. Cleared May 2026. https://www.510kdatabase.net/k261038/ 2026-05-29 monthly 0.8 https://www.510kdatabase.net/og-image/k261038-xpert-pfp-fda-510k.jpg K261038 - Xpert PFP K261038 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Newclip Technics. Cleared May 2026. https://www.510kdatabase.net/k261060/ 2026-05-29 monthly 0.8 https://www.510kdatabase.net/og-image/k261060-navigated-llif-impactable-tracker-fda-510k.jpg K261060 - Navigated LLIF Impactable Tracker K261060 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tyber Medical, LLC. Cleared May 2026. https://www.510kdatabase.net/k261159/ 2026-05-29 monthly 0.8 https://www.510kdatabase.net/og-image/k261159-exceed-biplanar-expandable-interbody-fda-510k.jpg K261159 - Exceed® Biplanar Expandable Interbody System K261159 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spine Wave, Inc.. Cleared May 2026. https://www.510kdatabase.net/k261202/ 2026-05-29 monthly 0.8 https://www.510kdatabase.net/og-image/k261202-entire-ire-system-fda-510k.jpg K261202 - ENTire IRE System K261202 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Entire Medical , Ltd.. Cleared May 2026. https://www.510kdatabase.net/k261369/ 2026-05-29 monthly 0.8 https://www.510kdatabase.net/og-image/k261369-gi-genius-module-300-ggm300-us-fda-510k.jpg K261369 - GI Genius™ Module 300 (GGM300-US) K261369 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cosmo Artificial Intelligence - Ai, Ltd.. Cleared May 2026. https://www.510kdatabase.net/k251840/ 2026-05-28 monthly 0.8 https://www.510kdatabase.net/og-image/k251840-zimmer-persona-personalized-knee-system-fda-510k.jpg K251840 - Zimmer® Persona® Personalized Knee System K251840 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared May 2026. https://www.510kdatabase.net/k252702/ 2026-05-28 monthly 0.8 https://www.510kdatabase.net/og-image/k252702-bioptimal-pulmonary-artery-monitoring-fda-510k.jpg K252702 - Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N K252702 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bioptimal International Pte. , Ltd.. Cleared May 2026. https://www.510kdatabase.net/k252712/ 2026-05-28 monthly 0.8 https://www.510kdatabase.net/og-image/k252712-stimpod-nms460-nerve-stimulator-fda-510k.jpg K252712 - STIMPOD NMS460 Nerve Stimulator K252712 is a FDA 510(k) cleared neurology medical device. Manufacturer: Algiamed Technologies USA, Inc.. Cleared May 2026. https://www.510kdatabase.net/k252823/ 2026-05-28 monthly 0.8 https://www.510kdatabase.net/og-image/k252823-dukal-crepe-paper-sterilization-wrap-fda-510k.jpg K252823 - Dukal Crepe Paper Sterilization Wrap K252823 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Dukal, LLC. Cleared May 2026. https://www.510kdatabase.net/k253530/ 2026-05-28 monthly 0.8 https://www.510kdatabase.net/og-image/k253530-trexon-monofilament-synthetic-fda-510k.jpg K253530 - Trexon™ Monofilament Synthetic Absorbable Suture K253530 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medtronic. Cleared May 2026. https://www.510kdatabase.net/k253894/ 2026-05-28 monthly 0.8 https://www.510kdatabase.net/og-image/k253894-bmd-titanium-spinal-fusion-system-fda-510k.jpg K253894 - BMD Titanium Spinal Fusion System K253894 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Global Biomedica s.r.o.. Cleared May 2026. https://www.510kdatabase.net/k253931/ 2026-05-28 monthly 0.8 https://www.510kdatabase.net/og-image/k253931-arthrex-bioabsorbable-pushlock-suture-fda-510k.jpg K253931 - Arthrex Bioabsorbable PushLock Suture Anchors K253931 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared May 2026. https://www.510kdatabase.net/k254092/ 2026-05-28 monthly 0.8 https://www.510kdatabase.net/og-image/k254092-bellalun-2d-vdms-1000s-fda-510k.jpg K254092 - Bellalun 2D (VDMS-1000S) K254092 is a FDA 510(k) cleared radiology medical device. Manufacturer: Vieworks Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k260213/ 2026-05-28 monthly 0.8 https://www.510kdatabase.net/og-image/k260213-bd-bactec-fxi-culture-system-fda-510k.jpg K260213 - BD BACTEC FXI Culture System K260213 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Diagnostic Systems. Cleared May 2026. https://www.510kdatabase.net/k260295/ 2026-05-28 monthly 0.8 https://www.510kdatabase.net/og-image/k260295-helio-kids-fda-510k.jpg K260295 - Helio Kids K260295 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Motion Composites. Cleared May 2026. https://www.510kdatabase.net/k260423/ 2026-05-28 monthly 0.8 https://www.510kdatabase.net/og-image/k260423-disposable-endoscopic-distal-attachments-fda-510k.jpg K260423 - Disposable Endoscopic Distal Attachments K260423 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Yangzhou Fartley Medical Instrument Technology Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k260895/ 2026-05-28 monthly 0.8 https://www.510kdatabase.net/og-image/k260895-ulike-clear-zero-yc10-bu-fda-510k.jpg K260895 - Ulike Clear Zero (YC10 BU) K260895 is a FDA 510(k) cleared neurology medical device. Manufacturer: Guangxi Ulike Medical Technology Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k261037/ 2026-05-28 monthly 0.8 https://www.510kdatabase.net/og-image/k261037-780-nm-spy-portable-handheld-imaging-fda-510k.jpg K261037 - 780 nm SPY Portable Handheld Imaging (SPY-PHI) System K261037 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker Endoscopy. Cleared May 2026. https://www.510kdatabase.net/k261405/ 2026-05-28 monthly 0.8 https://www.510kdatabase.net/og-image/k261405-andi-22-fda-510k.jpg K261405 - ANDI 2.2 K261405 is a FDA 510(k) cleared radiology medical device. Manufacturer: Imeka Solutions, Inc.. Cleared May 2026. https://www.510kdatabase.net/k252930/ 2026-05-27 monthly 0.8 https://www.510kdatabase.net/og-image/k252930-aqua-laminoplasty-systems-fda-510k.jpg K252930 - AQUA Laminoplasty Systems K252930 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: ZheJiang Decans Medical Devices Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k253130/ 2026-05-27 monthly 0.8 https://www.510kdatabase.net/og-image/k253130-dione-peek-screw-system-fda-510k.jpg K253130 - Dione PEEK Screw System K253130 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: ZheJiang Decans Medical Devices Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k253212/ 2026-05-27 monthly 0.8 https://www.510kdatabase.net/og-image/k253212-xr-series-xr-10-xr-20-automated-fda-510k.jpg K253212 - XR-Series (XR-10, XR-20) Automated Hematology Analyzers K253212 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sysmex America, Inc.. Cleared May 2026. https://www.510kdatabase.net/k253971/ 2026-05-27 monthly 0.8 https://www.510kdatabase.net/og-image/k253971-visby-medical-flu-and-covid-19-test-fda-510k.jpg K253971 - Visby Medical Flu and COVID-19 Test K253971 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Visby Medical, Inc.. Cleared May 2026. https://www.510kdatabase.net/k254075/ 2026-05-27 monthly 0.8 https://www.510kdatabase.net/og-image/k254075-synapse-lung-nodule-ai-fda-510k.jpg K254075 - Synapse Lung Nodule AI K254075 is a FDA 510(k) cleared radiology medical device. Manufacturer: Fujifilm Corporation. Cleared May 2026. https://www.510kdatabase.net/k254102/ 2026-05-27 monthly 0.8 https://www.510kdatabase.net/og-image/k254102-glucommander-fda-510k.jpg K254102 - Glucommander K254102 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Glytec, LLC. Cleared May 2026. https://www.510kdatabase.net/k254104/ 2026-05-27 monthly 0.8 https://www.510kdatabase.net/og-image/k254104-resscan-essentials-fda-510k.jpg K254104 - ResScan Essentials K254104 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: ResMed Corp. Cleared May 2026. https://www.510kdatabase.net/k254265/ 2026-05-27 monthly 0.8 https://www.510kdatabase.net/og-image/k254265-helion-viewer-suite-fda-510k.jpg K254265 - Helion Viewer Suite K254265 is a FDA 510(k) cleared radiology medical device. Manufacturer: Videomed Srl ( a Baxter Healthcare Corp company). Cleared May 2026. https://www.510kdatabase.net/k260123/ 2026-05-27 monthly 0.8 https://www.510kdatabase.net/og-image/k260123-epiq-series-diagnostic-ultrasound-system-fda-510k.jpg K260123 - EPIQ Series Diagnostic Ultrasound System K260123 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Ultrasound, LLC. Cleared May 2026. https://www.510kdatabase.net/k260142/ 2026-05-27 monthly 0.8 https://www.510kdatabase.net/og-image/k260142-stimelmd-ssmd-system-fda-510k.jpg K260142 - StimelMD (SSMD) system K260142 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Motion Informatics ltd.. Cleared May 2026. https://www.510kdatabase.net/k260207/ 2026-05-27 monthly 0.8 https://www.510kdatabase.net/og-image/k260207-multimodality-simulation-workspace-mm-fda-510k.jpg K260207 - Multimodality Simulation Workspace (MM Sim) (v1.0.0) K260207 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared May 2026. https://www.510kdatabase.net/k260367/ 2026-05-27 monthly 0.8 https://www.510kdatabase.net/og-image/k260367-portable-dental-x-ray-system-model-pdx-fda-510k.jpg K260367 - Portable Dental X-ray System Model PDX nova K260367 is a FDA 510(k) cleared radiology medical device. Manufacturer: PDX Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k260646/ 2026-05-27 monthly 0.8 https://www.510kdatabase.net/og-image/k260646-renasys-edge-66803126-fda-510k.jpg K260646 - RENASYS EDGE (66803126) K260646 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew Medical, Ltd.. Cleared May 2026. https://www.510kdatabase.net/k260680/ 2026-05-27 monthly 0.8 https://www.510kdatabase.net/og-image/k260680-epiq-series-diagnostic-ultrasound-fda-510k.jpg K260680 - EPIQ Series Diagnostic Ultrasound Systems K260680 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Ultrasound, LLC. Cleared May 2026. https://www.510kdatabase.net/k261374/ 2026-05-27 monthly 0.8 https://www.510kdatabase.net/og-image/k261374-ligapass-system-fda-510k.jpg K261374 - LigaPASS™ System K261374 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medicrea International S.A.S. Cleared May 2026. https://www.510kdatabase.net/k252790/ 2026-05-26 monthly 0.8 https://www.510kdatabase.net/og-image/k252790-digital-clarusscope-system-and-digital-fda-510k.jpg K252790 - Digital ClarusScope System and Digital NeuroPEN System K252790 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Clarus Medical, LLC. Cleared May 2026. https://www.510kdatabase.net/k252797/ 2026-05-26 monthly 0.8 https://www.510kdatabase.net/og-image/k252797-jazbi-resorbable-bone-void-filler-fda-510k.jpg K252797 - JAZBI™ Resorbable Bone Void Filler K252797 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Sdip Innovations Pty, Ltd.. Cleared May 2026. https://www.510kdatabase.net/k252833/ 2026-05-26 monthly 0.8 https://www.510kdatabase.net/og-image/k252833-viva-combo-rf-system-fda-510k.jpg K252833 - VIVA combo RF System K252833 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Starmed Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k253629/ 2026-05-26 monthly 0.8 https://www.510kdatabase.net/og-image/k253629-momcozy-nasal-aspirator-bn007-fda-510k.jpg K253629 - Momcozy Nasal Aspirator (BN007) K253629 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Shenzhen Root Innovation Technology Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k254157/ 2026-05-26 monthly 0.8 https://www.510kdatabase.net/og-image/k254157-crossnav-navigation-enabled-fda-510k.jpg K254157 - CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody K254157 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International SARL. Cleared May 2026. https://www.510kdatabase.net/k260318/ 2026-05-26 monthly 0.8 https://www.510kdatabase.net/og-image/k260318-4k-niricg-imaging-system-fda-510k.jpg K260318 - 4K NIR/ICG Imaging System K260318 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Zhejiang Healnoc Technology Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k260398/ 2026-05-26 monthly 0.8 https://www.510kdatabase.net/og-image/k260398-logiq-e-fda-510k.jpg K260398 - LOGIQ e K260398 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared May 2026. https://www.510kdatabase.net/k260183/ 2026-05-24 monthly 0.8 https://www.510kdatabase.net/og-image/k260183-medibot-needle-driver-uno-fda-510k.jpg K260183 - MediBot Needle Driver Uno K260183 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Parallel Robotics, LLC. Cleared May 2026. https://www.510kdatabase.net/k252735/ 2026-05-22 monthly 0.8 https://www.510kdatabase.net/og-image/k252735-c-beam-fda-510k.jpg K252735 - C-beam K252735 is a FDA 510(k) cleared radiology medical device. Manufacturer: Pulmera, Inc.. Cleared May 2026. https://www.510kdatabase.net/k252772/ 2026-05-22 monthly 0.8 https://www.510kdatabase.net/og-image/k252772-arc-adjustable-radial-cuff-compression-fda-510k.jpg K252772 - Arc Adjustable Radial Cuff Compression Device K252772 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Tz Medical, Inc.. Cleared May 2026. https://www.510kdatabase.net/k252784/ 2026-05-22 monthly 0.8 https://www.510kdatabase.net/og-image/k252784-exaskin-plus-fda-510k.jpg K252784 - eXaSkin Plus K252784 is a FDA 510(k) cleared radiology medical device. Manufacturer: Anatomical Geometry S.L.. Cleared May 2026. https://www.510kdatabase.net/k252887/ 2026-05-22 monthly 0.8 https://www.510kdatabase.net/og-image/k252887-depuy-attune-knee-system-fda-510k.jpg K252887 - DePuy ATTUNE™ Knee System K252887 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared May 2026. https://www.510kdatabase.net/k252915/ 2026-05-22 monthly 0.8 https://www.510kdatabase.net/og-image/k252915-aisteth-fda-510k.jpg K252915 - AiSteth® K252915 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ai Health Highway India Pvt., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k252917/ 2026-05-22 monthly 0.8 https://www.510kdatabase.net/og-image/k252917-atlaas-atraumatic-left-atrial-fda-510k.jpg K252917 - ATLAAS (Atraumatic Left Atrial Appendage System) (AD) K252917 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Genesee Biomedical, Inc.. Cleared May 2026. https://www.510kdatabase.net/k253060/ 2026-05-22 monthly 0.8 https://www.510kdatabase.net/og-image/k253060-sterile-latex-powder-free-surgical-fda-510k.jpg K253060 - Sterile Latex Powder Free Surgical Gloves K253060 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Protect Gloves Company Limited. Cleared May 2026. https://www.510kdatabase.net/k253359/ 2026-05-22 monthly 0.8 https://www.510kdatabase.net/og-image/k253359-zenith-distal-access-long-sheath-fda-510k.jpg K253359 - Zenith Distal Access Long Sheath K253359 is a FDA 510(k) cleared neurology medical device. Manufacturer: Suzhou Zenith Vascular SciTech Limited. Cleared May 2026. https://www.510kdatabase.net/k253569/ 2026-05-22 monthly 0.8 https://www.510kdatabase.net/og-image/k253569-atmo-gas-capsule-system-fda-510k.jpg K253569 - Atmo Gas Capsule System K253569 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Atmo Biosciences, Ltd.. Cleared May 2026. https://www.510kdatabase.net/k253773/ 2026-05-22 monthly 0.8 https://www.510kdatabase.net/og-image/k253773-guanhong-sharps-container-ghw-1f1-fda-510k.jpg K253773 - Guanhong Sharps Container (GHW-1F1) K253773 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Taizhou Huangyan Guanhong Plastic Steel Products Factory. Cleared May 2026. https://www.510kdatabase.net/k253949/ 2026-05-22 monthly 0.8 https://www.510kdatabase.net/og-image/k253949-sonoport-series-digital-color-doppler-fda-510k.jpg K253949 - SonoPort Series Digital Color Doppler Ultrasound System (SonoPort 1, SonoPort 1 Exp, SonoPort 1 Pro, SonoPort 1 Elite, SonoPort 1 Plus, SonoPort 2, SonoPort 2 Exp, SonoPort 2 Pro, SonoPort 2 Elite, SonoPort 2 Plus, SonoPort 3, SonoPort 3 Exp, SonoPort 3 Pro, SonoPort 3 Elite, SonoPort 3 Plus, SonoPort 4, SonoPort 4 Exp, SonoPort 4 Pro, SonoPort 4 Elite, SonoPort 4 Plus, SonoPort 5, SonoPort 5 Exp, SonoPort 5 Pro, SonoPort 5 Elite, SonoPort 5 Plus, SonoPort 6, SonoPort 6 Exp, SonoPort 6 K253949 is a FDA 510(k) cleared radiology medical device. Manufacturer: CHISON Medical Technologies Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k254129/ 2026-05-22 monthly 0.8 https://www.510kdatabase.net/og-image/k254129-spectrum-2-fda-510k.jpg K254129 - Spectrum-2 K254129 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Neko Health AB. Cleared May 2026. https://www.510kdatabase.net/k254137/ 2026-05-22 monthly 0.8 https://www.510kdatabase.net/og-image/k254137-inqwire-amplatz-guide-wire-fda-510k.jpg K254137 - InQwire Amplatz Guide Wire K254137 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Ireland, Ltd.. Cleared May 2026. https://www.510kdatabase.net/k260113/ 2026-05-22 monthly 0.8 https://www.510kdatabase.net/og-image/k260113-umr-astra-fda-510k.jpg K260113 - uMR Astra K260113 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k260189/ 2026-05-22 monthly 0.8 https://www.510kdatabase.net/og-image/k260189-magventure-accelerated-tms-atms-fda-510k.jpg K260189 - MagVenture Accelerated TMS (aTMS) Therapy System K260189 is a FDA 510(k) cleared neurology medical device. Manufacturer: Tonica Elektronik A/S. Cleared May 2026. https://www.510kdatabase.net/k260324/ 2026-05-22 monthly 0.8 https://www.510kdatabase.net/og-image/k260324-vitrea-ct-transcatheter-aortic-valve-fda-510k.jpg K260324 - Vitrea CT Transcatheter Aortic Valve Replacement (TAVR) Planning K260324 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Informatics, Inc.. Cleared May 2026. https://www.510kdatabase.net/k260329/ 2026-05-22 monthly 0.8 https://www.510kdatabase.net/og-image/k260329-ion-c-navigation-instruments-fda-510k.jpg K260329 - Ion-C Navigation Instruments K260329 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SurGenTec, LLC. Cleared May 2026. https://www.510kdatabase.net/k260560/ 2026-05-22 monthly 0.8 https://www.510kdatabase.net/og-image/k260560-apollo-tms-therapy-system-fda-510k.jpg K260560 - Apollo TMS Therapy System K260560 is a FDA 510(k) cleared neurology medical device. Manufacturer: Mag & More GmbH. Cleared May 2026. https://www.510kdatabase.net/k260695/ 2026-05-22 monthly 0.8 https://www.510kdatabase.net/og-image/k260695-da-vinci-firefly-imaging-system-fda-510k.jpg K260695 - da Vinci Firefly Imaging System K260695 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical. Cleared May 2026. https://www.510kdatabase.net/k261098/ 2026-05-22 monthly 0.8 https://www.510kdatabase.net/og-image/k261098-tetragraph-neuromuscular-transmission-fda-510k.jpg K261098 - TetraGraph Neuromuscular Transmission Monitor (SEN 2015)Accessories:TetraSens (SEN 2012)TetraSens Pediatric (SEN 2013)TetraSensitive (SEN 2016)TetraHub (SEN 2017) K261098 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Senzime AB. Cleared May 2026. https://www.510kdatabase.net/k261280/ 2026-05-22 monthly 0.8 https://www.510kdatabase.net/og-image/k261280-biosieve-multi-drug-urine-test-panel-fda-510k.jpg K261280 - BioSieve Multi-Drug Urine Test Panel K261280 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Vivachek Biotech (Hangzhou) Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/den250057/ 2026-05-22 monthly 0.8 https://www.510kdatabase.net/og-image/den250057-pcwp-analysis-software-fda-510k.jpg DEN250057 - PCWP Analysis Software DEN250057 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cardiosense, Inc.. Cleared May 2026. https://www.510kdatabase.net/k251920/ 2026-05-21 monthly 0.8 https://www.510kdatabase.net/og-image/k251920-sleep-apnea-breathing-therapy-fda-510k.jpg K251920 - Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask K251920 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Dcstar, Inc.. Cleared May 2026. https://www.510kdatabase.net/k252746/ 2026-05-21 monthly 0.8 https://www.510kdatabase.net/og-image/k252746-atlan-a100-fda-510k.jpg K252746 - Atlan (A100) K252746 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Dr?gerwerk AG & Co KGaA. Cleared May 2026. https://www.510kdatabase.net/k253112/ 2026-05-21 monthly 0.8 https://www.510kdatabase.net/og-image/k253112-sofjec-single-use-needle-fda-510k.jpg K253112 - Sofjec (Single use Needle) K253112 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hlb Lifescience Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k253191/ 2026-05-21 monthly 0.8 https://www.510kdatabase.net/og-image/k253191-dcmhotbond-zircon-fda-510k.jpg K253191 - DCMhotbond zircon K253191 is a FDA 510(k) cleared dental medical device. Manufacturer: Dental Creativ Management GmbH. Cleared May 2026. https://www.510kdatabase.net/k253245/ 2026-05-21 monthly 0.8 https://www.510kdatabase.net/og-image/k253245-boston-2910-boston-2910-fda-510k.jpg K253245 - Boston 2910 (Boston 2910) K253245 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Boston Aesthetics, Inc.. Cleared May 2026. https://www.510kdatabase.net/k253352/ 2026-05-21 monthly 0.8 https://www.510kdatabase.net/og-image/k253352-pegavision-polymacon-daily-disposable-fda-510k.jpg K253352 - Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses K253352 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Pegavision Corporation. Cleared May 2026. https://www.510kdatabase.net/k253720/ 2026-05-21 monthly 0.8 https://www.510kdatabase.net/og-image/k253720-usonique-nova-usonique-nova-elite-fda-510k.jpg K253720 - uSONIQUE Nova, uSONIQUE Nova Elite, uSONIQUE Vita, uSONIQUE Vita Elite, uSONIQUE Grace, uSONIQUE Grace Elite K253720 is a FDA 510(k) cleared radiology medical device. Manufacturer: Wuhan United Imaging Healthcare Co.,Ltd. Cleared May 2026. https://www.510kdatabase.net/k253816/ 2026-05-21 monthly 0.8 https://www.510kdatabase.net/og-image/k253816-mucover-proposed-name-oral-wound-fda-510k.jpg K253816 - MuCover (proposed name) Oral Wound Dressing K253816 is a FDA 510(k) cleared dental medical device. Manufacturer: MoleculeX Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k253956/ 2026-05-21 monthly 0.8 https://www.510kdatabase.net/og-image/k253956-progrip-advanced-self-gripping-fda-510k.jpg K253956 - ProGrip™ advanced self-gripping polypropylene mesh (ADG1510, ADG2015, ADG3020, ADG4030) K253956 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sofradim Production. Cleared May 2026. https://www.510kdatabase.net/k254131/ 2026-05-21 monthly 0.8 https://www.510kdatabase.net/og-image/k254131-bac-fda-510k.jpg K254131 - BAC K254131 is a FDA 510(k) cleared radiology medical device. Manufacturer: DeepHealth, Inc.. Cleared May 2026. https://www.510kdatabase.net/k254141/ 2026-05-21 monthly 0.8 https://www.510kdatabase.net/og-image/k254141-manual-wheelchair-dy019032-fda-510k.jpg K254141 - Manual Wheelchair (DY01903(2)) K254141 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Guangdong Dayang Medical Technology Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k254244/ 2026-05-21 monthly 0.8 https://www.510kdatabase.net/og-image/k254244-wearable-breast-pump-model-s39-fda-510k.jpg K254244 - Wearable Breast Pump (Model S39) K254244 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shenzhen TPH Technology Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k260066/ 2026-05-21 monthly 0.8 https://www.510kdatabase.net/og-image/k260066-panopticai-vital-signs-161-22-fda-510k.jpg K260066 - PanopticAI Vital Signs (1.6.1-22) K260066 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: PanopticAI technologies Limited. Cleared May 2026. https://www.510kdatabase.net/k260068/ 2026-05-21 monthly 0.8 https://www.510kdatabase.net/og-image/k260068-pjur-nature-touch-100-ml-fda-510k.jpg K260068 - pjur NATURE Touch, 100 ml K260068 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Pjur Group Luxembourg S.A.. Cleared May 2026. https://www.510kdatabase.net/k260234/ 2026-05-21 monthly 0.8 https://www.510kdatabase.net/og-image/k260234-msk-go-fda-510k.jpg K260234 - MSK Go K260234 is a FDA 510(k) cleared radiology medical device. Manufacturer: Smart Alfa Teknoloji San. Ve Tic. A.S.. Cleared May 2026. https://www.510kdatabase.net/k260580/ 2026-05-21 monthly 0.8 https://www.510kdatabase.net/og-image/k260580-single-use-reloadable-clip-applicator-fda-510k.jpg K260580 - Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR) K260580 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared May 2026. https://www.510kdatabase.net/k260582/ 2026-05-21 monthly 0.8 https://www.510kdatabase.net/og-image/k260582-rosa-shoulder-system-fda-510k.jpg K260582 - ROSA® Shoulder System K260582 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthosoft Inc. (d/b/a) Zimmer CAS. Cleared May 2026. https://www.510kdatabase.net/k260618/ 2026-05-21 monthly 0.8 https://www.510kdatabase.net/og-image/k260618-ulthera-system-fda-510k.jpg K260618 - Ulthera® System K260618 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ulthera, Inc.. Cleared May 2026. https://www.510kdatabase.net/k260649/ 2026-05-21 monthly 0.8 https://www.510kdatabase.net/og-image/k260649-oes-elite-cystoscope-and-accessories-fda-510k.jpg K260649 - OES ELITE Cystoscope and Accessories K260649 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Winter & Ibe GmbH. Cleared May 2026. https://www.510kdatabase.net/k260962/ 2026-05-21 monthly 0.8 https://www.510kdatabase.net/og-image/k260962-sphincterotome-fda-510k.jpg K260962 - Sphincterotome K260962 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Taewoong Medical Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k261291/ 2026-05-21 monthly 0.8 https://www.510kdatabase.net/og-image/k261291-nisus-npwt-canister-500-ml-cpc-500-fda-510k.jpg K261291 - Nisus NPWT Canister 500-mL (CPC-500) K261291 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cork Medical. Cleared May 2026. https://www.510kdatabase.net/k261315/ 2026-05-21 monthly 0.8 https://www.510kdatabase.net/og-image/k261315-symbia-prospecta-q3-11364751-fda-510k.jpg K261315 - Symbia Pro.specta Q3 (11364751) K261315 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 2026. https://www.510kdatabase.net/k261325/ 2026-05-21 monthly 0.8 https://www.510kdatabase.net/og-image/k261325-ice-cooling-ipl-hair-removal-device-fda-510k.jpg K261325 - Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU) K261325 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Ulike Smart Electronics Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k261359/ 2026-05-21 monthly 0.8 https://www.510kdatabase.net/og-image/k261359-stelo-glucose-biosensor-system-fda-510k.jpg K261359 - Stelo Glucose Biosensor System K261359 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dexcom, Inc.. Cleared May 2026. https://www.510kdatabase.net/den250028/ 2026-05-21 monthly 0.8 https://www.510kdatabase.net/og-image/den250028-deepview-ai-system-fda-510k.jpg DEN250028 - DeepView AI® System DEN250028 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Spectralmd, Inc.. Cleared May 2026. https://www.510kdatabase.net/k252707/ 2026-05-20 monthly 0.8 https://www.510kdatabase.net/og-image/k252707-zenith-aspiration-catheter-fda-510k.jpg K252707 - Zenith Aspiration Catheter K252707 is a FDA 510(k) cleared neurology medical device. Manufacturer: Suzhou Zenith Vascular SciTech Limited. Cleared May 2026. https://www.510kdatabase.net/k252717/ 2026-05-20 monthly 0.8 https://www.510kdatabase.net/og-image/k252717-maastro-rectal-applicator-set-fda-510k.jpg K252717 - MAASTRO Rectal Applicator Set K252717 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems. Cleared May 2026. https://www.510kdatabase.net/k253134/ 2026-05-20 monthly 0.8 https://www.510kdatabase.net/og-image/k253134-lagis-endoscopic-instruments-scissors-fda-510k.jpg K253134 - LAGIS Endoscopic Instruments- Scissors (EI-330S EI-330S-T EI-330MS EI-330MS-T) K253134 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lagis Enterprise Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k253570/ 2026-05-20 monthly 0.8 https://www.510kdatabase.net/og-image/k253570-blood-pressure-monitor-w06lt-fda-510k.jpg K253570 - Blood Pressure Monitor (W06LT) K253570 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Jamr Technology Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k253596/ 2026-05-20 monthly 0.8 https://www.510kdatabase.net/og-image/k253596-aquilion-one-tsx-308atsx-306a-v20-fda-510k.jpg K253596 - Aquilion ONE (TSX-308A/TSX-306A) V2.0 K253596 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared May 2026. https://www.510kdatabase.net/k253774/ 2026-05-20 monthly 0.8 https://www.510kdatabase.net/og-image/k253774-elos-accurate-denture-fixation-system-fda-510k.jpg K253774 - Elos Accurate® Denture Fixation System K253774 is a FDA 510(k) cleared dental medical device. Manufacturer: Elos Medtech Pinol A/S. Cleared May 2026. https://www.510kdatabase.net/k253911/ 2026-05-20 monthly 0.8 https://www.510kdatabase.net/og-image/k253911-derma-2-fda-510k.jpg K253911 - Derma-2 K253911 is a FDA 510(k) cleared radiology medical device. Manufacturer: Neko Health AB. Cleared May 2026. https://www.510kdatabase.net/k260098/ 2026-05-20 monthly 0.8 https://www.510kdatabase.net/og-image/k260098-epm-series-patient-monitor-epm-10epm-fda-510k.jpg K260098 - ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC) K260098 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k260304/ 2026-05-20 monthly 0.8 https://www.510kdatabase.net/og-image/k260304-wave-pta-balloon-catheter-fda-510k.jpg K260304 - WAVE PTA Balloon Catheter K260304 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: WAVE Medical AG. Cleared May 2026. https://www.510kdatabase.net/k260351/ 2026-05-20 monthly 0.8 https://www.510kdatabase.net/og-image/k260351-numen-helia-coil-embolization-system-fda-510k.jpg K260351 - Numen™ Helia Coil Embolization System K260351 is a FDA 510(k) cleared neurology medical device. Manufacturer: MicroPort NeuroTech (Shanghai) Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k260594/ 2026-05-20 monthly 0.8 https://www.510kdatabase.net/og-image/k260594-ipl-hair-removal-device-fl-b505ag-fl-fda-510k.jpg K260594 - IPL Hair Removal Device (FL-B505AG, FL-B505AP, FL-B505AM, FL-B507AG, FL-B507AP, FL-B507AM, FL-B508AG, FL-B508AP, FL-B508AM, FL-B509AG, FL-B509AP, FL-B509AM, FL-B510G, FL-B510P, FL-B510M, FL-B511G, FL-B511P, FL-B511M, FL-B512AG, FL-B512AP, FL-B512AM, FL-B513AG, FL-B513AP, FL-B513AM) K260594 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Xiazhifeng Electronic Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k260717/ 2026-05-20 monthly 0.8 https://www.510kdatabase.net/og-image/k260717-mobility-scooter-air-carbon-fda-510k.jpg K260717 - Mobility Scooter (Air Carbon) K260717 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k261286/ 2026-05-20 monthly 0.8 https://www.510kdatabase.net/og-image/k261286-the-circadia-c300-system-c300-fda-510k.jpg K261286 - The Circadia C300 System (C300) K261286 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Circadia Health, Inc.. Cleared May 2026. https://www.510kdatabase.net/k251270/ 2026-05-19 monthly 0.8 https://www.510kdatabase.net/og-image/k251270-taperloc-complete-hip-stem-fda-510k.jpg K251270 - Taperloc® Complete Hip Stem K251270 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared May 2026. https://www.510kdatabase.net/k252985/ 2026-05-19 monthly 0.8 https://www.510kdatabase.net/og-image/k252985-laport-fda-510k.jpg K252985 - Laport K252985 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sejong Medical Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k253309/ 2026-05-19 monthly 0.8 https://www.510kdatabase.net/og-image/k253309-soga-lasers-therapy-system-family-of-fda-510k.jpg K253309 - SOGA Lasers therapy system family of Aurora handpiece (Aurora-S) K253309 is a FDA 510(k) cleared dental medical device. Manufacturer: Shenzhen Soga Technology Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k253722/ 2026-05-19 monthly 0.8 https://www.510kdatabase.net/og-image/k253722-liaison-plex-gastrointestinal-flex-assay-fda-510k.jpg K253722 - LIAISON PLEX Gastrointestinal Flex Assay K253722 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Luminex Corporation. Cleared May 2026. https://www.510kdatabase.net/k254024/ 2026-05-19 monthly 0.8 https://www.510kdatabase.net/og-image/k254024-mr5-activ-pro-fda-510k.jpg K254024 - MR5 Activ Pro K254024 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Multi Radiance Medical, Inc.. Cleared May 2026. https://www.510kdatabase.net/k260146/ 2026-05-19 monthly 0.8 https://www.510kdatabase.net/og-image/k260146-fitbone-transport-and-lengthening-system-fda-510k.jpg K260146 - FITBONE® TRANSPORT AND LENGTHENING SYSTEM K260146 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthofix Srl. Cleared May 2026. https://www.510kdatabase.net/k260268/ 2026-05-19 monthly 0.8 https://www.510kdatabase.net/og-image/k260268-orthoeasy-pal-fda-510k.jpg K260268 - OrthoEasy Pal K260268 is a FDA 510(k) cleared dental medical device. Manufacturer: Bernhard Förster GmbH (Bernhard Foerster Ltd.). Cleared May 2026. https://www.510kdatabase.net/k260577/ 2026-05-19 monthly 0.8 https://www.510kdatabase.net/og-image/k260577-filmarray-tf-control-panel-m527-fda-510k.jpg K260577 - FilmArray TF Control Panel M527 K260577 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Maine Molecular Quality Controls, Inc.. Cleared May 2026. https://www.510kdatabase.net/k261071/ 2026-05-19 monthly 0.8 https://www.510kdatabase.net/og-image/k261071-diafil-bulk-flow-economic-package-fda-510k.jpg K261071 - DIAFIL Bulk FLOW (Economic Package) K261071 is a FDA 510(k) cleared dental medical device. Manufacturer: DiaDent Group International. Cleared May 2026. https://www.510kdatabase.net/k261299/ 2026-05-19 monthly 0.8 https://www.510kdatabase.net/og-image/k261299-pegavision-toufilcon-b-daily-fda-510k.jpg K261299 - Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses K261299 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Pegavision Corporation. Cleared May 2026. https://www.510kdatabase.net/k252047/ 2026-05-18 monthly 0.8 https://www.510kdatabase.net/og-image/k252047-stratafix-symmetric-pds-plus-knotless-fda-510k.jpg K252047 - STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Devices K252047 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared May 2026. https://www.510kdatabase.net/k253295/ 2026-05-18 monthly 0.8 https://www.510kdatabase.net/og-image/k253295-coude-sleeved-ic-fda-510k.jpg K253295 - Coude Sleeved IC K253295 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hollister Incorporated. Cleared May 2026. https://www.510kdatabase.net/k253454/ 2026-05-18 monthly 0.8 https://www.510kdatabase.net/og-image/k253454-halyard-one-step-sterilization-wrap-fda-510k.jpg K253454 - HALYARD* ONE-STEP* Sterilization Wrap K253454 is a FDA 510(k) cleared general hospital medical device. Manufacturer: O&M Halyard, Inc.. Cleared May 2026. https://www.510kdatabase.net/k253831/ 2026-05-18 monthly 0.8 https://www.510kdatabase.net/og-image/k253831-cmn-capillary-function-with-virtual-fda-510k.jpg K253831 - CMN Capillary Function with Virtual Expert for MRI, CT and CBCT K253831 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cercare Medical A/S. Cleared May 2026. https://www.510kdatabase.net/k254109/ 2026-05-18 monthly 0.8 https://www.510kdatabase.net/og-image/k254109-g-cem-universal-fda-510k.jpg K254109 - G-CEM UNIVERSAL K254109 is a FDA 510(k) cleared dental medical device. Manufacturer: GC America, Inc.. Cleared May 2026. https://www.510kdatabase.net/k260100/ 2026-05-18 monthly 0.8 https://www.510kdatabase.net/og-image/k260100-moses-raydar-fda-510k.jpg K260100 - MOSES Raydar™ K260100 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared May 2026. https://www.510kdatabase.net/k260522/ 2026-05-18 monthly 0.8 https://www.510kdatabase.net/og-image/k260522-rhinaer-stylus-fda-510k.jpg K260522 - RhinAer+ Stylus K260522 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Aerin Medical, Inc.. Cleared May 2026. https://www.510kdatabase.net/k260840/ 2026-05-16 monthly 0.8 https://www.510kdatabase.net/og-image/k260840-bluex-cervical-expandable-cage-system-fda-510k.jpg K260840 - BluEX Cervical Expandable Cage System K260840 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: L & K Biomed Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k252377/ 2026-05-15 monthly 0.8 https://www.510kdatabase.net/og-image/k252377-nxstage-system-one-with-nxview-fda-510k.jpg K252377 - NxStage System One with NxView K252377 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC. Cleared May 2026. https://www.510kdatabase.net/k252423/ 2026-05-15 monthly 0.8 https://www.510kdatabase.net/og-image/k252423-novaline-tubing-set-for-hemodialysis-fda-510k.jpg K252423 - NovaLine Tubing Set for Hemodialysis (BL 124) K252423 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Bain Medical Equipment (Guangzhou) Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k252563/ 2026-05-15 monthly 0.8 https://www.510kdatabase.net/og-image/k252563-neurophet-scale-pet-fda-510k.jpg K252563 - Neurophet SCALE PET K252563 is a FDA 510(k) cleared radiology medical device. Manufacturer: Neurophet., Inc.. Cleared May 2026. https://www.510kdatabase.net/k252624/ 2026-05-15 monthly 0.8 https://www.510kdatabase.net/og-image/k252624-karl-storz-laryngoscopes-and-accessories-fda-510k.jpg K252624 - KARL STORZ Laryngoscopes and Accessories K252624 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared May 2026. https://www.510kdatabase.net/k252643/ 2026-05-15 monthly 0.8 https://www.510kdatabase.net/og-image/k252643-iso-gard-filter-straight-fda-510k.jpg K252643 - Iso-Gard Filter Straight K252643 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Teleflex Medical Sdn. Bhd.. Cleared May 2026. https://www.510kdatabase.net/k253235/ 2026-05-15 monthly 0.8 https://www.510kdatabase.net/og-image/k253235-introcan-safety-deep-access-xl-iv-fda-510k.jpg K253235 - Introcan Safety® Deep Access XL IV Catheter K253235 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared May 2026. https://www.510kdatabase.net/k253642/ 2026-05-15 monthly 0.8 https://www.510kdatabase.net/og-image/k253642-jada-system-jada-2002-fda-510k.jpg K253642 - Jada System (Jada-2002) K253642 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Organon, LLC. Cleared May 2026. https://www.510kdatabase.net/k253716/ 2026-05-15 monthly 0.8 https://www.510kdatabase.net/og-image/k253716-usonique-genesis-usonique-genesis-pro-fda-510k.jpg K253716 - uSONIQUE Genesis, uSONIQUE Genesis Pro, uSONIQUE Genesis Elite, uSONIQUE Genesis Super, uSONIQUE Pulse, uSONIQUE Pulse Pro, uSONIQUE Pulse Elite, uSONIQUE Pulse Super, uSONIQUE Venus, uSONIQUE Venus Pro, uSONIQUE Venus Elite, uSONIQUE Venus Super K253716 is a FDA 510(k) cleared radiology medical device. Manufacturer: Wuhan United Imaging Healthcare Co.,Ltd. Cleared May 2026. https://www.510kdatabase.net/k253756/ 2026-05-15 monthly 0.8 https://www.510kdatabase.net/og-image/k253756-cobas-liat-ctng-nucleic-acid-test-fda-510k.jpg K253756 - cobas liat CT/NG nucleic acid test K253756 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Molecular Systems, Inc.. Cleared May 2026. https://www.510kdatabase.net/k253759/ 2026-05-15 monthly 0.8 https://www.510kdatabase.net/og-image/k253759-cobas-liat-ctngmg-nucleic-acid-test-fda-510k.jpg K253759 - cobas liat CT/NG/MG nucleic acid test K253759 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Molecular Systems, Inc.. Cleared May 2026. https://www.510kdatabase.net/k253935/ 2026-05-15 monthly 0.8 https://www.510kdatabase.net/og-image/k253935-medxion-nexus-fda-510k.jpg K253935 - medXion NEXUS K253935 is a FDA 510(k) cleared radiology medical device. Manufacturer: medXion Technologies, Inc.. Cleared May 2026. https://www.510kdatabase.net/k254028/ 2026-05-15 monthly 0.8 https://www.510kdatabase.net/og-image/k254028-digital-color-doppler-ultrasound-fda-510k.jpg K254028 - Digital Color Doppler Ultrasound System (Autra RS, Autra 90, Autra Senior, Autra CV, e-Autra, Autra 75, Autra 85W, Autra 65, Autra 55, Autra 65i, Autra 90 Elite, Autra 85 Elite, Autra 80 Elite, Autra 75 Elite, Autra 85 CV, Autra 80W, Autra 65 Elite, Autra 55 Elite, Autra 55i, Autra 90 CV, Autra 85, Autra 80, Autra 80 CV, Autra 75 Pro, Autra 75W, Autra 70 Elite, Autra 70, Autra T) K254028 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sonoscape Medical Corp.. Cleared May 2026. https://www.510kdatabase.net/k254050/ 2026-05-15 monthly 0.8 https://www.510kdatabase.net/og-image/k254050-manual-tissue-removal-device-fda-510k.jpg K254050 - Manual Tissue Removal Device K254050 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Suzhou AcuVu Medical Technology Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k254120/ 2026-05-15 monthly 0.8 https://www.510kdatabase.net/og-image/k254120-subtlehd-ct-1x-fda-510k.jpg K254120 - SubtleHD-CT (1.x) K254120 is a FDA 510(k) cleared radiology medical device. Manufacturer: Subtle Medical, Inc.. Cleared May 2026. https://www.510kdatabase.net/k260059/ 2026-05-15 monthly 0.8 https://www.510kdatabase.net/og-image/k260059-noveos-specific-ige-sige-fda-510k.jpg K260059 - NOVEOS Specific IgE (sIgE) K260059 is a FDA 510(k) cleared immunology medical device. Manufacturer: Hycor Biomedical. Cleared May 2026. https://www.510kdatabase.net/k260134/ 2026-05-15 monthly 0.8 https://www.510kdatabase.net/og-image/k260134-baby-nasal-aspirator-bn006-bn006-a-fda-510k.jpg K260134 - Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02 K260134 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Shenzhen Root Innovation Technology Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k260506/ 2026-05-15 monthly 0.8 https://www.510kdatabase.net/og-image/k260506-ventana-pt-lumbar-interbody-system-fda-510k.jpg K260506 - Ventana® P/T Lumbar Interbody System K260506 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinal Elements, Inc.. Cleared May 2026. https://www.510kdatabase.net/k260536/ 2026-05-15 monthly 0.8 https://www.510kdatabase.net/og-image/k260536-prostalac-hip-system-smartset-vg-dual-fda-510k.jpg K260536 - Prostalac Hip System, SmartSet V+G Dual Antibiotic Bone Cement K260536 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Ireland UC. Cleared May 2026. https://www.510kdatabase.net/k260771/ 2026-05-15 monthly 0.8 https://www.510kdatabase.net/og-image/k260771-truselect-26-microcatheter-fda-510k.jpg K260771 - TruSelect™ 2.6 Microcatheter K260771 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared May 2026. https://www.510kdatabase.net/k260989/ 2026-05-15 monthly 0.8 https://www.510kdatabase.net/og-image/k260989-varion-thoracolumbar-fixation-system-fda-510k.jpg K260989 - Varion Thoracolumbar Fixation System K260989 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Kyocera Medical Technologies Inc. (KMTI). Cleared May 2026. https://www.510kdatabase.net/k261264/ 2026-05-15 monthly 0.8 https://www.510kdatabase.net/og-image/k261264-stellaris-elite-vision-enhancement-fda-510k.jpg K261264 - Stellaris Elite™ vision enhancement system K261264 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Bausch and Lomb. Cleared May 2026. https://www.510kdatabase.net/k261273/ 2026-05-15 monthly 0.8 https://www.510kdatabase.net/og-image/k261273-neurophet-aqua-fda-510k.jpg K261273 - Neurophet AQUA K261273 is a FDA 510(k) cleared radiology medical device. Manufacturer: Neurophet., Inc.. Cleared May 2026. https://www.510kdatabase.net/k261289/ 2026-05-15 monthly 0.8 https://www.510kdatabase.net/og-image/k261289-unid-spine-analyzer-sw3002-fda-510k.jpg K261289 - UNiD™ Spine Analyzer (SW3002) K261289 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medicrea International S.A.S. (Medtronic). Cleared May 2026. https://www.510kdatabase.net/k252601/ 2026-05-14 monthly 0.8 https://www.510kdatabase.net/og-image/k252601-pelvic-muscle-trainer-pc22a-fda-510k.jpg K252601 - Pelvic Muscle Trainer (PC22A) K252601 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hunan Accurate Bio-Medical Technology Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k252652/ 2026-05-14 monthly 0.8 https://www.510kdatabase.net/og-image/k252652-disposable-syringes-with-accessories-fda-510k.jpg K252652 - Disposable Syringes with Accessories for Power Injectors (900103T) K252652 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Fortis Biosolutions Company Limited. Cleared May 2026. https://www.510kdatabase.net/k252776/ 2026-05-14 monthly 0.8 https://www.510kdatabase.net/og-image/k252776-aries-anterior-cervical-plate-systems-fda-510k.jpg K252776 - ARIES Anterior Cervical Plate Systems K252776 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: ZheJiang Decans Medical Devices Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k253078/ 2026-05-14 monthly 0.8 https://www.510kdatabase.net/og-image/k253078-art1-us-fda-510k.jpg K253078 - ART.1-US K253078 is a FDA 510(k) cleared radiology medical device. Manufacturer: Seetreat Pty, Ltd.. Cleared May 2026. https://www.510kdatabase.net/k253372/ 2026-05-14 monthly 0.8 https://www.510kdatabase.net/og-image/k253372-et-healing-abutments-fda-510k.jpg K253372 - ET Healing Abutments K253372 is a FDA 510(k) cleared dental medical device. Manufacturer: Hiossen, Inc.. Cleared May 2026. https://www.510kdatabase.net/k253676/ 2026-05-14 monthly 0.8 https://www.510kdatabase.net/og-image/k253676-corus-posterior-cervical-stabilization-fda-510k.jpg K253676 - CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D) K253676 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Providence Medical Technology, Inc.. Cleared May 2026. https://www.510kdatabase.net/k253883/ 2026-05-14 monthly 0.8 https://www.510kdatabase.net/og-image/k253883-bonalive-maxillofacial-fda-510k.jpg K253883 - Bonalive Maxillofacial K253883 is a FDA 510(k) cleared dental medical device. Manufacturer: Bonalive , Ltd.. Cleared May 2026. https://www.510kdatabase.net/k254013/ 2026-05-14 monthly 0.8 https://www.510kdatabase.net/og-image/k254013-subtlehd-pet-1x-fda-510k.jpg K254013 - SubtleHD-PET (1.x) K254013 is a FDA 510(k) cleared radiology medical device. Manufacturer: Subtle Medical, Inc.. Cleared May 2026. https://www.510kdatabase.net/k254048/ 2026-05-14 monthly 0.8 https://www.510kdatabase.net/og-image/k254048-wrist-watch-electronic-blood-pressure-fda-510k.jpg K254048 - Wrist Watch Electronic Blood Pressure Monitor (U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T) K254048 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Urion Technology Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k254133/ 2026-05-14 monthly 0.8 https://www.510kdatabase.net/og-image/k254133-entity-usb-videoscope-system-fda-510k.jpg K254133 - ENTity USB Videoscope System K254133 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Optim, LLC. Cleared May 2026. https://www.510kdatabase.net/k260085/ 2026-05-14 monthly 0.8 https://www.510kdatabase.net/og-image/k260085-raymo-mobile-x-ray-system-model-raymo-fda-510k.jpg K260085 - RAYMO Mobile X-ray System (Model: RAYMO) K260085 is a FDA 510(k) cleared radiology medical device. Manufacturer: DRGEM Corporation. Cleared May 2026. https://www.510kdatabase.net/k260111/ 2026-05-14 monthly 0.8 https://www.510kdatabase.net/og-image/k260111-palmtop-ultrasound-diagnostic-system-fda-510k.jpg K260111 - Palmtop Ultrasound Diagnostic System (MT10P/MT10) K260111 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mytech Intelligence (Shenzhen) Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k260485/ 2026-05-14 monthly 0.8 https://www.510kdatabase.net/og-image/k260485-any-etch-fda-510k.jpg K260485 - Any-Etch K260485 is a FDA 510(k) cleared dental medical device. Manufacturer: Mediclus Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k260565/ 2026-05-14 monthly 0.8 https://www.510kdatabase.net/og-image/k260565-smartclip-delivery-catheter-adr-1715-fda-510k.jpg K260565 - SmartClip Delivery Catheter (ADR-1715) K260565 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Elucent Medical. Cleared May 2026. https://www.510kdatabase.net/k260892/ 2026-05-14 monthly 0.8 https://www.510kdatabase.net/og-image/k260892-suction-pump-su-90-fda-510k.jpg K260892 - Suction Pump (SU-90) K260892 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen HugeMed Medical Technical Development Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k261134/ 2026-05-14 monthly 0.8 https://www.510kdatabase.net/og-image/k261134-dormiva-anti-snoring-mouth-guard-fda-510k.jpg K261134 - Dormiva Anti-Snoring Mouth Guard K261134 is a FDA 510(k) cleared dental medical device. Manufacturer: Koncept Innovators, Inc.. Cleared May 2026. https://www.510kdatabase.net/k261224/ 2026-05-14 monthly 0.8 https://www.510kdatabase.net/og-image/k261224-matriderm-fda-510k.jpg K261224 - MatriDerm K261224 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medskin Solutions Dr. Suwelack AG. Cleared May 2026. https://www.510kdatabase.net/k261241/ 2026-05-14 monthly 0.8 https://www.510kdatabase.net/og-image/k261241-trimed-compression-screws-fda-510k.jpg K261241 - TriMed Compression Screws K261241 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: TriMed, Inc.. Cleared May 2026. https://www.510kdatabase.net/k261317/ 2026-05-14 monthly 0.8 https://www.510kdatabase.net/og-image/k261317-briefcase-triage-fda-510k.jpg K261317 - BriefCase-Triage K261317 is a FDA 510(k) cleared radiology medical device. Manufacturer: Aidoc Medical , Ltd.. Cleared May 2026. https://www.510kdatabase.net/k252591/ 2026-05-13 monthly 0.8 https://www.510kdatabase.net/og-image/k252591-automatic-micro-needle-system-code-x-fda-510k.jpg K252591 - Automatic Micro Needle System (CODE-X) K252591 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Woorhi Mechatronics Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k252638/ 2026-05-13 monthly 0.8 https://www.510kdatabase.net/og-image/k252638-verapro-s100-multi-use-syringe-018808-fda-510k.jpg K252638 - VeraPro S100 Multi-Use Syringe (018808) K252638 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Acist Medical Systems, Inc.. Cleared May 2026. https://www.510kdatabase.net/k252653/ 2026-05-13 monthly 0.8 https://www.510kdatabase.net/og-image/k252653-acist-pro-diagnostic-system-019304-fda-510k.jpg K252653 - ACIST Pro Diagnostic System (019304) K252653 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Acist Medical Systems, Inc.. Cleared May 2026. https://www.510kdatabase.net/k253061/ 2026-05-13 monthly 0.8 https://www.510kdatabase.net/og-image/k253061-portable-neuromodulation-stimulator-pons-fda-510k.jpg K253061 - Portable Neuromodulation Stimulator (PoNS) K253061 is a FDA 510(k) cleared neurology medical device. Manufacturer: Helius Medical, Inc.. Cleared May 2026. https://www.510kdatabase.net/k253181/ 2026-05-13 monthly 0.8 https://www.510kdatabase.net/og-image/k253181-surgimage-sim-1000h-fluorescence-fda-510k.jpg K253181 - SURGIMAGE SIM 1000H Fluorescence Imaging Platform K253181 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Surgimage Corporation. Cleared May 2026. https://www.510kdatabase.net/k253241/ 2026-05-13 monthly 0.8 https://www.510kdatabase.net/og-image/k253241-electric-wheelchair-y207bl-fda-510k.jpg K253241 - Electric Wheelchair (Y207BL) K253241 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Jiangsu Intco Medical Products Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k254073/ 2026-05-13 monthly 0.8 https://www.510kdatabase.net/og-image/k254073-statseal-disc-fda-510k.jpg K254073 - StatSeal Disc K254073 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared May 2026. https://www.510kdatabase.net/k254125/ 2026-05-13 monthly 0.8 https://www.510kdatabase.net/og-image/k254125-electric-breast-pump-hl-3058-ii-pro-fda-510k.jpg K254125 - Electric Breast Pump (HL-3058 II Pro) K254125 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k260032/ 2026-05-13 monthly 0.8 https://www.510kdatabase.net/og-image/k260032-morph-fda-510k.jpg K260032 - Morph K260032 is a FDA 510(k) cleared radiology medical device. Manufacturer: BeauBrain Healthcare, Inc.. Cleared May 2026. https://www.510kdatabase.net/k261363/ 2026-05-13 monthly 0.8 https://www.510kdatabase.net/og-image/k261363-y-knotless-flex-anchors-fda-510k.jpg K261363 - Y-Knotless™ Flex Anchors K261363 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Conmed Corporation. Cleared May 2026. https://www.510kdatabase.net/k252731/ 2026-05-12 monthly 0.8 https://www.510kdatabase.net/og-image/k252731-promimic-zrp-surface-dental-implant-fda-510k.jpg K252731 - Promimic ZrP Surface Dental Implant K252731 is a FDA 510(k) cleared dental medical device. Manufacturer: Promimic AB. Cleared May 2026. https://www.510kdatabase.net/k254192/ 2026-05-12 monthly 0.8 https://www.510kdatabase.net/og-image/k254192-senhance-ultrasonic-system-fda-510k.jpg K254192 - Senhance Ultrasonic System K254192 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Asensus Surgical. Cleared May 2026. https://www.510kdatabase.net/k260051/ 2026-05-12 monthly 0.8 https://www.510kdatabase.net/og-image/k260051-corvision-91-205-z0014-fda-510k.jpg K260051 - CorVision® (91-205-Z0014) K260051 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Corvent Medical, Inc.. Cleared May 2026. https://www.510kdatabase.net/k260235/ 2026-05-12 monthly 0.8 https://www.510kdatabase.net/og-image/k260235-celldx-tissue-fda-510k.jpg K260235 - CellDx-Tissue K260235 is a FDA 510(k) cleared pathology medical device. Manufacturer: Datar Cancer Genetics Private Limited. Cleared May 2026. https://www.510kdatabase.net/k260378/ 2026-05-12 monthly 0.8 https://www.510kdatabase.net/og-image/k260378-rayvolve-fda-510k.jpg K260378 - Rayvolve K260378 is a FDA 510(k) cleared radiology medical device. Manufacturer: AZmed. Cleared May 2026. https://www.510kdatabase.net/k260415/ 2026-05-12 monthly 0.8 https://www.510kdatabase.net/og-image/k260415-myledmask-2-mj-144-fda-510k.jpg K260415 - myLEDmask 2 (MJ-144) K260415 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Light Tree Ventures Europe B.V.. Cleared May 2026. https://www.510kdatabase.net/k260473/ 2026-05-12 monthly 0.8 https://www.510kdatabase.net/og-image/k260473-electric-nasal-aspirator-bc027-bc030-fda-510k.jpg K260473 - Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B) K260473 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Shenzhen Kingboom Technology Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k260725/ 2026-05-12 monthly 0.8 https://www.510kdatabase.net/og-image/k260725-bamer-surgical-gowns-cop01-cop04-cop05-fda-510k.jpg K260725 - BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10) K260725 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hindernis DE Mexico, S.A.P.I. DE C.V.. Cleared May 2026. https://www.510kdatabase.net/k260837/ 2026-05-12 monthly 0.8 https://www.510kdatabase.net/og-image/k260837-versalift-expandable-system-fda-510k.jpg K260837 - VersaLift Expandable System K260837 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared May 2026. https://www.510kdatabase.net/k260850/ 2026-05-12 monthly 0.8 https://www.510kdatabase.net/og-image/k260850-osteomni-spinal-cages-system-fda-510k.jpg K260850 - OSTEOMNI SPINAL CAGES SYSTEM K260850 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OSTEOMNI, Inc.. Cleared May 2026. https://www.510kdatabase.net/k261196/ 2026-05-12 monthly 0.8 https://www.510kdatabase.net/og-image/k261196-promisemed-veriecto-automatic-biopsy-fda-510k.jpg K261196 - Promisemed VeriEcto Automatic Biopsy Needles K261196 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Promisemed Hangzhou Meditech Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k250964/ 2026-05-11 monthly 0.8 https://www.510kdatabase.net/og-image/k250964-protable-phlegm-suction-unit-jma-d01-fda-510k.jpg K250964 - Protable Phlegm Suction Unit (JMA D01) K250964 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Jiangsu Jumao X-Care Medical Equipment Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k252655/ 2026-05-11 monthly 0.8 https://www.510kdatabase.net/og-image/k252655-pulse-oximeter-po-a2ao-po-a2at-po-a3ao-fda-510k.jpg K252655 - Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT) K252655 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Imdk Medical Technology Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k252880/ 2026-05-11 monthly 0.8 https://www.510kdatabase.net/og-image/k252880-pytheas-your-guided-trajectory-fda-510k.jpg K252880 - Pytheas Your Guided Trajectory K252880 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Pytheas Navigation Sas. Cleared May 2026. https://www.510kdatabase.net/k252953/ 2026-05-11 monthly 0.8 https://www.510kdatabase.net/og-image/k252953-velmeni-for-dentists-v4d-endo-perio-fda-510k.jpg K252953 - Velmeni for Dentists (V4D) Endo-Perio K252953 is a FDA 510(k) cleared radiology medical device. Manufacturer: Velmeni, Inc.. Cleared May 2026. https://www.510kdatabase.net/k253696/ 2026-05-11 monthly 0.8 https://www.510kdatabase.net/og-image/k253696-cflex-cystoscope-standard-deflection-fda-510k.jpg K253696 - CFlex Cystoscope - Standard Deflection (0570-0455) K253696 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Verathon Medical (Canada) Ulc. Cleared May 2026. https://www.510kdatabase.net/k254178/ 2026-05-11 monthly 0.8 https://www.510kdatabase.net/og-image/k254178-saya-86-radial-access-guide-catheter-fda-510k.jpg K254178 - SAYA 86 Radial Access Guide Catheter K254178 is a FDA 510(k) cleared neurology medical device. Manufacturer: Asahi Intecc Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k254228/ 2026-05-11 monthly 0.8 https://www.510kdatabase.net/og-image/k254228-karl-storz-trocars-with-valve-seals-fda-510k.jpg K254228 - KARL STORZ Trocars with Valve Seals K254228 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Karl Storz SE & CO. KG. Cleared May 2026. https://www.510kdatabase.net/k260196/ 2026-05-11 monthly 0.8 https://www.510kdatabase.net/og-image/k260196-ethicon-circular-stapler-cdh21mm-fda-510k.jpg K260196 - ETHICON™ Circular Stapler (CDH21mm) K260196 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon Endo-Surgery, LLC. Cleared May 2026. https://www.510kdatabase.net/k260805/ 2026-05-11 monthly 0.8 https://www.510kdatabase.net/og-image/k260805-dual-core-fda-510k.jpg K260805 - Dual Core K260805 is a FDA 510(k) cleared dental medical device. Manufacturer: Vericom Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k260842/ 2026-05-11 monthly 0.8 https://www.510kdatabase.net/og-image/k260842-hardydisk-ast-gepotidacin-10g-gep10-fda-510k.jpg K260842 - HardyDisk AST Gepotidacin 10µg (GEP10) K260842 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Hardy Diagnostics. Cleared May 2026. https://www.510kdatabase.net/k260846/ 2026-05-11 monthly 0.8 https://www.510kdatabase.net/og-image/k260846-diagnostic-ultrasound-system-mu9-fda-510k.jpg K260846 - Diagnostic Ultrasound System (MU9) K260846 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k261214/ 2026-05-11 monthly 0.8 https://www.510kdatabase.net/og-image/k261214-pico-shining-pico-k-fda-510k.jpg K261214 - PICO SHINING (PICO-K K261214 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Speclipse, Inc.. Cleared May 2026. https://www.510kdatabase.net/k260385/ 2026-05-09 monthly 0.8 https://www.510kdatabase.net/og-image/k260385-aprevo-anterior-and-lateral-lumbar-fda-510k.jpg K260385 - aprevo® anterior and lateral lumbar interbody system K260385 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Carlsmed, Inc.. Cleared May 2026. https://www.510kdatabase.net/k261145/ 2026-05-09 monthly 0.8 https://www.510kdatabase.net/og-image/k261145-avanti-distal-elbow-orif-system-fda-510k.jpg K261145 - Avanti Distal Elbow ORIF System K261145 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Avanti Orthopaedics, LLC. Cleared May 2026. https://www.510kdatabase.net/k250814/ 2026-05-08 monthly 0.8 https://www.510kdatabase.net/og-image/k250814-alegria-flash-ssa-60-fda-510k.jpg K250814 - Alegria Flash SSA-60 K250814 is a FDA 510(k) cleared immunology medical device. Manufacturer: Zeus Scientific. Cleared May 2026. https://www.510kdatabase.net/k252617/ 2026-05-08 monthly 0.8 https://www.510kdatabase.net/og-image/k252617-mirocam-capsule-endoscope-system-fda-510k.jpg K252617 - MiroCam® Capsule Endoscope System K252617 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Intromedic Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k252621/ 2026-05-08 monthly 0.8 https://www.510kdatabase.net/og-image/k252621-deepskin-dep100-fda-510k.jpg K252621 - DeepSkin (DEP100) K252621 is a FDA 510(k) cleared neurology medical device. Manufacturer: El Global Trade, Ltd.. Cleared May 2026. https://www.510kdatabase.net/k253013/ 2026-05-08 monthly 0.8 https://www.510kdatabase.net/og-image/k253013-disposable-stone-retrieval-balloon-fda-510k.jpg K253013 - Disposable Stone Retrieval Balloon Catheter K253013 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Zhejiang Soudon Medical Technology Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k253237/ 2026-05-08 monthly 0.8 https://www.510kdatabase.net/og-image/k253237-elde-medical-electrodes-t5-5-cm-x-5cm-fda-510k.jpg K253237 - Elde Medical Electrodes (T5/ 5 cm x 5cm electrode T10/ 5 cm x 10cm electrode) K253237 is a FDA 510(k) cleared neurology medical device. Manufacturer: Elde Medikal Sanayi ve Ticaret Anonim Sirketi. Cleared May 2026. https://www.510kdatabase.net/k253396/ 2026-05-08 monthly 0.8 https://www.510kdatabase.net/og-image/k253396-ayon-body-contouring-system-ayon-system-fda-510k.jpg K253396 - AYON Body Contouring System™ (AYON SYSTEM) K253396 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Apyx Medical Corporation. Cleared May 2026. https://www.510kdatabase.net/k253679/ 2026-05-08 monthly 0.8 https://www.510kdatabase.net/og-image/k253679-hydro-irrigation-system-fda-510k.jpg K253679 - Hydro Irrigation System K253679 is a FDA 510(k) cleared neurology medical device. Manufacturer: Stryker Instruments. Cleared May 2026. https://www.510kdatabase.net/k253991/ 2026-05-08 monthly 0.8 https://www.510kdatabase.net/og-image/k253991-fitbone-trochanteric-fitbone-transport-fda-510k.jpg K253991 - Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA K253991 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthofix Srl. Cleared May 2026. https://www.510kdatabase.net/k254215/ 2026-05-08 monthly 0.8 https://www.510kdatabase.net/og-image/k254215-arthrex-beaming-system-fda-510k.jpg K254215 - Arthrex Beaming System K254215 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared May 2026. https://www.510kdatabase.net/k260321/ 2026-05-08 monthly 0.8 https://www.510kdatabase.net/og-image/k260321-hipguide-v-1000-fda-510k.jpg K260321 - HipGuide (V 1.0.0.0) K260321 is a FDA 510(k) cleared radiology medical device. Manufacturer: Orthopedic Driven Imaging, LLC. Cleared May 2026. https://www.510kdatabase.net/k260419/ 2026-05-08 monthly 0.8 https://www.510kdatabase.net/og-image/k260419-lingoral-dental-design-system-fda-510k.jpg K260419 - LingOral Dental Design System K260419 is a FDA 510(k) cleared dental medical device. Manufacturer: Hangzhou ChohoTech Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k260788/ 2026-05-08 monthly 0.8 https://www.510kdatabase.net/og-image/k260788-smylio-aligners-fda-510k.jpg K260788 - Smylio Aligners K260788 is a FDA 510(k) cleared dental medical device. Manufacturer: Smylio, Inc.. Cleared May 2026. https://www.510kdatabase.net/k260792/ 2026-05-08 monthly 0.8 https://www.510kdatabase.net/og-image/k260792-aerframe-patient-immobilization-system-fda-510k.jpg K260792 - AerFrame Patient Immobilization System (AFPIS) K260792 is a FDA 510(k) cleared radiology medical device. Manufacturer: Stabilix, LLC. Cleared May 2026. https://www.510kdatabase.net/den250013/ 2026-05-08 monthly 0.8 https://www.510kdatabase.net/og-image/den250013-modius-spero-fda-510k.jpg DEN250013 - Modius Spero DEN250013 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neurovalens Limited. Cleared May 2026. https://www.510kdatabase.net/k253647/ 2026-05-07 monthly 0.8 https://www.510kdatabase.net/og-image/k253647-evita-v800-fda-510k.jpg K253647 - Evita (V800) K253647 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Draegerwerk AG & CO Kgaa. Cleared May 2026. https://www.510kdatabase.net/k253739/ 2026-05-07 monthly 0.8 https://www.510kdatabase.net/og-image/k253739-script-rods-creo-stabilization-system-fda-510k.jpg K253739 - SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® 4.5 Stabilization System, NuVasive Reline™ System K253739 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared May 2026. https://www.510kdatabase.net/k253826/ 2026-05-07 monthly 0.8 https://www.510kdatabase.net/og-image/k253826-aliya-ex-system-fda-510k.jpg K253826 - Aliya® EX System K253826 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Galvanize Therapeutics, Inc.. Cleared May 2026. https://www.510kdatabase.net/k253837/ 2026-05-07 monthly 0.8 https://www.510kdatabase.net/og-image/k253837-spectralis-hraoct-and-variants-fda-510k.jpg K253837 - SPECTRALIS HRA+OCT and variants K253837 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Heidelberg Engineering GmbH. Cleared May 2026. https://www.510kdatabase.net/k253992/ 2026-05-07 monthly 0.8 https://www.510kdatabase.net/og-image/k253992-veritas-reverse-total-shoulder-system-fda-510k.jpg K253992 - Veritas Reverse Total Shoulder System K253992 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Restor3d. Cleared May 2026. https://www.510kdatabase.net/k254183/ 2026-05-07 monthly 0.8 https://www.510kdatabase.net/og-image/k254183-mr-conditional-cup-electrodes-fda-510k.jpg K254183 - MR Conditional Cup Electrodes K254183 is a FDA 510(k) cleared neurology medical device. Manufacturer: Technomed Europe. Cleared May 2026. https://www.510kdatabase.net/k254276/ 2026-05-07 monthly 0.8 https://www.510kdatabase.net/og-image/k254276-lynx-aspiration-catheter-system-fda-510k.jpg K254276 - Lynx Aspiration Catheter System K254276 is a FDA 510(k) cleared neurology medical device. Manufacturer: Q'Apel Medical, Inc.. Cleared May 2026. https://www.510kdatabase.net/k260460/ 2026-05-07 monthly 0.8 https://www.510kdatabase.net/og-image/k260460-neodent-gold-hue-custom-abutments-fda-510k.jpg K260460 - Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue K260460 is a FDA 510(k) cleared dental medical device. Manufacturer: Institut Straumann AG. Cleared May 2026. https://www.510kdatabase.net/k260974/ 2026-05-07 monthly 0.8 https://www.510kdatabase.net/og-image/k260974-co2-laser-machine-monica-imonica-ii-fda-510k.jpg K260974 - CO2 Laser Machine (Monica-I,Monica-II) K260974 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Nanjing Bestview Laser S&T Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k252552/ 2026-05-06 monthly 0.8 https://www.510kdatabase.net/og-image/k252552-pelvic-floor-rehabilitation-therapy-fda-510k.jpg K252552 - Pelvic Floor Rehabilitation Therapy Device (PD2301/PD2302/PD2303) K252552 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Shenzhen Changkun Technology Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k253027/ 2026-05-06 monthly 0.8 https://www.510kdatabase.net/og-image/k253027-anchor-with-fiber-wire-and-disposable-fda-510k.jpg K253027 - Anchor with Fiber Wire and Disposable Inserter K253027 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ortobio S.A.. Cleared May 2026. https://www.510kdatabase.net/k253152/ 2026-05-06 monthly 0.8 https://www.510kdatabase.net/og-image/k253152-bp1000-ultra-compact-fingertip-blood-fda-510k.jpg K253152 - BP1000 Ultra-Compact Fingertip Blood Pressure Monitor (BP1000) K253152 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biozen, LLC. Cleared May 2026. https://www.510kdatabase.net/k253855/ 2026-05-06 monthly 0.8 https://www.510kdatabase.net/og-image/k253855-kardiapsi-balloon-catheter-fda-510k.jpg K253855 - KardiaPSI Balloon Catheter K253855 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intervention Tech, Inc. ; dba Corvention. Cleared May 2026. https://www.510kdatabase.net/k260376/ 2026-05-06 monthly 0.8 https://www.510kdatabase.net/og-image/k260376-denture-base-fda-510k.jpg K260376 - Denture Base K260376 is a FDA 510(k) cleared dental medical device. Manufacturer: Shandong Huge Dental Material Corporation. Cleared May 2026. https://www.510kdatabase.net/k260747/ 2026-05-06 monthly 0.8 https://www.510kdatabase.net/og-image/k260747-yp-710t-series-nibp-cuff-fda-510k.jpg K260747 - YP-710T Series NIBP Cuff K260747 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden Corporation. Cleared May 2026. https://www.510kdatabase.net/k260775/ 2026-05-06 monthly 0.8 https://www.510kdatabase.net/og-image/k260775-polyethylene-fda-510k.jpg K260775 - Polyethylene K260775 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Teleflex Medical, LLC. Cleared May 2026. https://www.510kdatabase.net/k261112/ 2026-05-06 monthly 0.8 https://www.510kdatabase.net/og-image/k261112-castleloc-p-anterior-cervical-plate-fda-510k.jpg K261112 - CastleLoc-P Anterior Cervical Plate System K261112 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: L & K Biomed Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k252558/ 2026-05-05 monthly 0.8 https://www.510kdatabase.net/og-image/k252558-lumify-diagnostic-ultrasound-system-fda-510k.jpg K252558 - Lumify Diagnostic Ultrasound System K252558 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Ultrasound, LLC. Cleared May 2026. https://www.510kdatabase.net/k254200/ 2026-05-05 monthly 0.8 https://www.510kdatabase.net/og-image/k254200-air-compression-leg-massager-lf-ft001-fda-510k.jpg K254200 - Air Compression Leg Massager (LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1, LF-FT004-1, LF-FT005-1, LF-FT006-1, LF-FT007, LF-FT008, LF-FT009, LF-FT010, LF-FT011, LF-FT012, LF-FT013, LF-FT014, LF-FT015, LF-FT016, UM-01, UM-02, UM-03, UM-03-1, UM-04-1, UM-05-1, UM-06-1, UM-07, UM-08, UM-09, UM-10, UM-11, UM-12, UM-13, UM-14, UM-15, UM-16, AI-01, AI-02, AI-03, AI-04, AI-05, AI-06, AI01, AI02, AI03, AI-07, AI-08, AI-09, AI-10, AI-11, AI-12, AI-13, AI-14) K254200 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Wenzhou Lingfeng Electronic Technology Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k254202/ 2026-05-05 monthly 0.8 https://www.510kdatabase.net/og-image/k254202-mectalif-3d-metal-anterior-fda-510k.jpg K254202 - MectaLIF 3D Metal Anterior K254202 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared May 2026. https://www.510kdatabase.net/k260742/ 2026-05-05 monthly 0.8 https://www.510kdatabase.net/og-image/k260742-ice-cooling-ipl-hair-removal-device-fda-510k.jpg K260742 - Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK) K260742 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Ulike Smart Electronics Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k261130/ 2026-05-05 monthly 0.8 https://www.510kdatabase.net/og-image/k261130-accelfix-spinal-fixation-system-fda-510k.jpg K261130 - AccelFix Spinal Fixation System K261130 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: L & K Biomed Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k261132/ 2026-05-05 monthly 0.8 https://www.510kdatabase.net/og-image/k261132-healium-intelliscan-lx192lc-fda-510k.jpg K261132 - Healium Intelliscan LX192LC K261132 is a FDA 510(k) cleared radiology medical device. Manufacturer: Healium Intelliscan Corporation. Cleared May 2026. https://www.510kdatabase.net/k252543/ 2026-05-04 monthly 0.8 https://www.510kdatabase.net/og-image/k252543-amsafe-administration-set-ba-70075-ba-fda-510k.jpg K252543 - AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04) K252543 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Amsino International, Inc.. Cleared May 2026. https://www.510kdatabase.net/k252622/ 2026-05-04 monthly 0.8 https://www.510kdatabase.net/og-image/k252622-male-latex-condom-ha-fda-510k.jpg K252622 - Male Latex Condom HA K252622 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Okamoto USA, Inc.. Cleared May 2026. https://www.510kdatabase.net/k252954/ 2026-05-04 monthly 0.8 https://www.510kdatabase.net/og-image/k252954-mammosightai-fda-510k.jpg K252954 - MammoSightAI K252954 is a FDA 510(k) cleared radiology medical device. Manufacturer: Neurocareai, Inc. (Dba Savelife.Ai). Cleared May 2026. https://www.510kdatabase.net/k253251/ 2026-05-04 monthly 0.8 https://www.510kdatabase.net/og-image/k253251-leaseir-mhr-xcell-console-mhr-100b-fda-510k.jpg K253251 - Leaseir MHR Xcell (console) (MHR-100b) K253251 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Leaseir Technologies, Slu. Cleared May 2026. https://www.510kdatabase.net/k254019/ 2026-05-04 monthly 0.8 https://www.510kdatabase.net/og-image/k254019-wound-geni-npwt-system-fda-510k.jpg K254019 - Wound Geni NPWT System K254019 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bechtel Medical, Inc.. Cleared May 2026. https://www.510kdatabase.net/k254115/ 2026-05-04 monthly 0.8 https://www.510kdatabase.net/og-image/k254115-arteraai-breast-fda-510k.jpg K254115 - ArteraAI Breast K254115 is a FDA 510(k) cleared pathology medical device. Manufacturer: Artera, Inc.. Cleared May 2026. https://www.510kdatabase.net/k260256/ 2026-05-04 monthly 0.8 https://www.510kdatabase.net/og-image/k260256-q-switched-nd-yag-laser-systems-fda-510k.jpg K260256 - Q-Switched Nd: YAG Laser Systems K260256 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shanghai Apolo Medical Technology Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k260688/ 2026-05-04 monthly 0.8 https://www.510kdatabase.net/og-image/k260688-sculpt-led-belt-hy-150ahy-150bhy-fda-510k.jpg K260688 - Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C) K260688 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Kaiyan Medical Equipment Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k260716/ 2026-05-04 monthly 0.8 https://www.510kdatabase.net/og-image/k260716-neowise-fda-510k.jpg K260716 - Neowise K260716 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cefla S.C.. Cleared May 2026. https://www.510kdatabase.net/k252073/ 2026-05-01 monthly 0.8 https://www.510kdatabase.net/og-image/k252073-voco-profluorid-varnish-biomin-fda-510k.jpg K252073 - VOCO Profluorid Varnish + BioMin K252073 is a FDA 510(k) cleared dental medical device. Manufacturer: Voco GmbH. Cleared May 2026. https://www.510kdatabase.net/k252439/ 2026-05-01 monthly 0.8 https://www.510kdatabase.net/og-image/k252439-tutamen-self-adhesive-electrodes-fda-510k.jpg K252439 - Tutamen Self Adhesive Electrodes K252439 is a FDA 510(k) cleared neurology medical device. Manufacturer: Dongguan Tutamen Metalwork Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k252475/ 2026-05-01 monthly 0.8 https://www.510kdatabase.net/og-image/k252475-abl90-flex-plus-system-fda-510k.jpg K252475 - ABL90 FLEX PLUS System K252475 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Radiometer Medicals Aps. Cleared May 2026. https://www.510kdatabase.net/k252488/ 2026-05-01 monthly 0.8 https://www.510kdatabase.net/og-image/k252488-abl90-flex-plus-system-fda-510k.jpg K252488 - ABL90 FLEX PLUS System K252488 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Radiometer Medicals Aps. Cleared May 2026. https://www.510kdatabase.net/k252635/ 2026-05-01 monthly 0.8 https://www.510kdatabase.net/og-image/k252635-arthrotak-tendon-anchor-kit-fda-510k.jpg K252635 - ArthroTAK Tendon Anchor Kit K252635 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: ArthroTAK, LLC. Cleared May 2026. https://www.510kdatabase.net/k253030/ 2026-05-01 monthly 0.8 https://www.510kdatabase.net/og-image/k253030-capnostream35-portable-respiratory-fda-510k.jpg K253030 - Capnostream™35 Portable Respiratory Monitor (PM35MN) K253030 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Covidien, LLC. Cleared May 2026. https://www.510kdatabase.net/k253326/ 2026-05-01 monthly 0.8 https://www.510kdatabase.net/og-image/k253326-oxiplex-fda-510k.jpg K253326 - Oxiplex K253326 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Fziomed, Inc.. Cleared May 2026. https://www.510kdatabase.net/k253663/ 2026-05-01 monthly 0.8 https://www.510kdatabase.net/og-image/k253663-zeta-navigation-system-fda-510k.jpg K253663 - Zeta Navigation System K253663 is a FDA 510(k) cleared neurology medical device. Manufacturer: Zeta Surgical, Inc.. Cleared May 2026. https://www.510kdatabase.net/k253887/ 2026-05-01 monthly 0.8 https://www.510kdatabase.net/og-image/k253887-nasal-alar-spo2-sensor-989803205381-fda-510k.jpg K253887 - Nasal Alar SpO2 Sensor (989803205381) K253887 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Philips Medizin Systeme. Cleared May 2026. https://www.510kdatabase.net/k253966/ 2026-05-01 monthly 0.8 https://www.510kdatabase.net/og-image/k253966-perla-tl-posterior-thoraco-lumbar-fda-510k.jpg K253966 - PERLA® TL Posterior Thoraco-lumbar Fixation System K253966 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spineart SA. Cleared May 2026. https://www.510kdatabase.net/k254077/ 2026-05-01 monthly 0.8 https://www.510kdatabase.net/og-image/k254077-ossiofiber-threaded-trimmable-fixation-fda-510k.jpg K254077 - OSSIOfiber® Threaded Trimmable Fixation Nail K254077 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OSSIO , Ltd.. Cleared May 2026. https://www.510kdatabase.net/k254139/ 2026-05-01 monthly 0.8 https://www.510kdatabase.net/og-image/k254139-biocode-respiratory-pathogen-panel-rpp-fda-510k.jpg K254139 - BioCode® Respiratory Pathogen Panel (RPP) K254139 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Applied BioCode, Inc.. Cleared May 2026. https://www.510kdatabase.net/k254154/ 2026-05-01 monthly 0.8 https://www.510kdatabase.net/og-image/k254154-fx-v135-easytech-shoulder-system-fda-510k.jpg K254154 - FX V135 EASYTECH® Shoulder System K254154 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: FX Shoulder Solutions, Inc.. Cleared May 2026. https://www.510kdatabase.net/k254234/ 2026-05-01 monthly 0.8 https://www.510kdatabase.net/og-image/k254234-phototherapy-system-duv-combo-fda-510k.jpg K254234 - Phototherapy System (DUV-COMBO) K254234 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Choyang Medics Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k260314/ 2026-05-01 monthly 0.8 https://www.510kdatabase.net/og-image/k260314-ancora-sb-fda-510k.jpg K260314 - Ancora-SB K260314 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Aspero Medical, Inc.. Cleared May 2026. https://www.510kdatabase.net/k260819/ 2026-05-01 monthly 0.8 https://www.510kdatabase.net/og-image/k260819-any-com-seal-fda-510k.jpg K260819 - Any-Com Seal K260819 is a FDA 510(k) cleared dental medical device. Manufacturer: Mediclus Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k260910/ 2026-05-01 monthly 0.8 https://www.510kdatabase.net/og-image/k260910-endotool-iv-cloud-10-fda-510k.jpg K260910 - EndoTool IV Cloud 1.0 K260910 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Glooko, Inc.. Cleared May 2026. https://www.510kdatabase.net/k261045/ 2026-05-01 monthly 0.8 https://www.510kdatabase.net/og-image/k261045-verifine-safety-lancets-fda-510k.jpg K261045 - Verifine Safety Lancets K261045 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Promisemed Hangzhou Meditech Co., Ltd.. Cleared May 2026. https://www.510kdatabase.net/k261074/ 2026-05-01 monthly 0.8 https://www.510kdatabase.net/og-image/k261074-biomonitor-iv-471155-fda-510k.jpg K261074 - BIOMONITOR IV (471155) K261074 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biotronik, Inc.. Cleared May 2026. https://www.510kdatabase.net/den240075/ 2026-05-01 monthly 0.8 https://www.510kdatabase.net/og-image/den240075-prolystica-pass-thru-disinfectant-wipes-fda-510k.jpg DEN240075 - Prolystica Pass Thru Disinfectant Wipes DEN240075 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Steris. Cleared May 2026. https://www.510kdatabase.net/k250680/ 2026-04-30 monthly 0.8 https://www.510kdatabase.net/og-image/k250680-bayesian-health-sepsis-flagging-device-fda-510k.jpg K250680 - Bayesian Health Sepsis Flagging Device K250680 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Bayesian Health, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k251583/ 2026-04-30 monthly 0.8 https://www.510kdatabase.net/og-image/k251583-ambu-virobac-ii-exhalation-filter-fda-510k.jpg K251583 - Ambu® Virobac II® Exhalation Filter K251583 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ambu A/S. Cleared Apr 2026. https://www.510kdatabase.net/k252455/ 2026-04-30 monthly 0.8 https://www.510kdatabase.net/og-image/k252455-fsyx-ocular-pressure-adjusting-pump-fda-510k.jpg K252455 - FSYX Ocular Pressure Adjusting Pump K252455 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Balance Ophthalmics, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k252503/ 2026-04-30 monthly 0.8 https://www.510kdatabase.net/og-image/k252503-intelligent-nr-fda-510k.jpg K252503 - Intelligent NR K252503 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k252849/ 2026-04-30 monthly 0.8 https://www.510kdatabase.net/og-image/k252849-afflovest-mobile-airway-clearance-fda-510k.jpg K252849 - AffloVest® Mobile Airway Clearance Therapy K252849 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Tactile Medical. Cleared Apr 2026. https://www.510kdatabase.net/k252858/ 2026-04-30 monthly 0.8 https://www.510kdatabase.net/og-image/k252858-4k-uhd-endoscopy-camera-system-kms-4k-fda-510k.jpg K252858 - 4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288) K252858 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Kms Medical Technology Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k253017/ 2026-04-30 monthly 0.8 https://www.510kdatabase.net/og-image/k253017-bloodstop-ix-trauma-matrix-tm-ix-20-fda-510k.jpg K253017 - BloodSTOP iX Trauma Matrix (TM-iX-20) K253017 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lifescience Plus, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k253064/ 2026-04-30 monthly 0.8 https://www.510kdatabase.net/og-image/k253064-air-pressure-therapy-system-vu-ipc8m-fda-510k.jpg K253064 - Air Pressure Therapy System (VU-IPC8M) K253064 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Xiamen Weiyou Intelligent Technology Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k253436/ 2026-04-30 monthly 0.8 https://www.510kdatabase.net/og-image/k253436-c-med0-alpha-fda-510k.jpg K253436 - c-med0 alpha K253436 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cosinuss GmbH. Cleared Apr 2026. https://www.510kdatabase.net/k253976/ 2026-04-30 monthly 0.8 https://www.510kdatabase.net/og-image/k253976-ilet-ace-pump-fda-510k.jpg K253976 - iLet ACE Pump K253976 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beta Bionics, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k254189/ 2026-04-30 monthly 0.8 https://www.510kdatabase.net/og-image/k254189-synapse-3d-base-tools-v72-fda-510k.jpg K254189 - Synapse 3D Base Tools (V7.2) K254189 is a FDA 510(k) cleared radiology medical device. Manufacturer: Fujifilm Corporation. Cleared Apr 2026. https://www.510kdatabase.net/k260323/ 2026-04-30 monthly 0.8 https://www.510kdatabase.net/og-image/k260323-orthopediatrics-locking-cannulated-fda-510k.jpg K260323 - OrthoPediatrics® Locking Cannulated Blade Plate System K260323 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OrthoPediatrics Corp.. Cleared Apr 2026. https://www.510kdatabase.net/k260342/ 2026-04-30 monthly 0.8 https://www.510kdatabase.net/og-image/k260342-alltest-strep-a-rapid-test-fda-510k.jpg K260342 - AllTest Strep A Rapid Test K260342 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Hangzhou AllTest Biotech Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k261067/ 2026-04-30 monthly 0.8 https://www.510kdatabase.net/og-image/k261067-bee-plif-cage-fda-510k.jpg K261067 - BEE PLIF Cage K261067 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: NGMedical GmbH. Cleared Apr 2026. https://www.510kdatabase.net/k261404/ 2026-04-30 monthly 0.8 https://www.510kdatabase.net/og-image/k261404-ultraez-fda-510k.jpg K261404 - UltraEZ K261404 is a FDA 510(k) cleared dental medical device. Manufacturer: Ultradent Products, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/den250023/ 2026-04-30 monthly 0.8 https://www.510kdatabase.net/og-image/den250023-aurie-system-fda-510k.jpg DEN250023 - Aurie System DEN250023 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cathbuddy, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k252471/ 2026-04-29 monthly 0.8 https://www.510kdatabase.net/og-image/k252471-paptizer-360-fda-510k.jpg K252471 - Paptizer 360 K252471 is a FDA 510(k) cleared general hospital medical device. Manufacturer: LiViliti Health Products Corporation. Cleared Apr 2026. https://www.510kdatabase.net/k252542/ 2026-04-29 monthly 0.8 https://www.510kdatabase.net/og-image/k252542-leo-spinal-system-fda-510k.jpg K252542 - LEO Spinal System K252542 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: ZheJiang Decans Medical Devices Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k253166/ 2026-04-29 monthly 0.8 https://www.510kdatabase.net/og-image/k253166-f6s-full-face-mask-f6s-fda-510k.jpg K253166 - F6S Full Face Mask (F6S) K253166 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: BMC Medical Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k253401/ 2026-04-29 monthly 0.8 https://www.510kdatabase.net/og-image/k253401-script-implant-system-fda-510k.jpg K253401 - SCRIPT™ Implant System K253401 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k253579/ 2026-04-29 monthly 0.8 https://www.510kdatabase.net/og-image/k253579-aristotle-14-guidewire-fda-510k.jpg K253579 - Aristotle 14 Guidewire K253579 is a FDA 510(k) cleared neurology medical device. Manufacturer: Scientia Vascular, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k253682/ 2026-04-29 monthly 0.8 https://www.510kdatabase.net/og-image/k253682-deephealth-prostateai-fda-510k.jpg K253682 - DeepHealth ProstateAI K253682 is a FDA 510(k) cleared radiology medical device. Manufacturer: Quantib B.V.. Cleared Apr 2026. https://www.510kdatabase.net/k253885/ 2026-04-29 monthly 0.8 https://www.510kdatabase.net/og-image/k253885-puscon-water-balance-1day-tint-fda-510k.jpg K253885 - PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS K253885 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: GEO MEDICAL CO., LTD.. Cleared Apr 2026. https://www.510kdatabase.net/k253914/ 2026-04-29 monthly 0.8 https://www.510kdatabase.net/og-image/k253914-momcozy-wearable-breast-pump-model-fda-510k.jpg K253914 - Momcozy Wearable Breast Pump (Model: BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434) K253914 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shenzhen Root Innovation Technology Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k254184/ 2026-04-29 monthly 0.8 https://www.510kdatabase.net/og-image/k254184-syngo-application-software-fda-510k.jpg K254184 - syngo Application Software K254184 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k260589/ 2026-04-29 monthly 0.8 https://www.510kdatabase.net/og-image/k260589-es-series-fda-510k.jpg K260589 - ES-Series K260589 is a FDA 510(k) cleared radiology medical device. Manufacturer: E-Scopics. Cleared Apr 2026. https://www.510kdatabase.net/k260606/ 2026-04-29 monthly 0.8 https://www.510kdatabase.net/og-image/k260606-echo-large-bore-introducer-sheath-fda-510k.jpg K260606 - Echo Large Bore Introducer Sheath K260606 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Echo Medical, LLC. Cleared Apr 2026. https://www.510kdatabase.net/k261086/ 2026-04-29 monthly 0.8 https://www.510kdatabase.net/og-image/k261086-break-wave-fda-510k.jpg K261086 - Break Wave K261086 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Sonomotion, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k261094/ 2026-04-29 monthly 0.8 https://www.510kdatabase.net/og-image/k261094-yellowstar-fda-510k.jpg K261094 - YellowStar K261094 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Asclepion Laser Technologies GmbH. Cleared Apr 2026. https://www.510kdatabase.net/k252424/ 2026-04-28 monthly 0.8 https://www.510kdatabase.net/og-image/k252424-anti-hcv-next-fda-510k.jpg K252424 - Anti-HCV Next K252424 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Apr 2026. https://www.510kdatabase.net/k252464/ 2026-04-28 monthly 0.8 https://www.510kdatabase.net/og-image/k252464-surgical-microscope-oms2360-oms2380-fda-510k.jpg K252464 - Surgical Microscope (OMS2360, OMS2380) K252464 is a FDA 510(k) cleared dental medical device. Manufacturer: Zumax Medical Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k252501/ 2026-04-28 monthly 0.8 https://www.510kdatabase.net/og-image/k252501-arm-type-fully-automatic-digital-blood-fda-510k.jpg K252501 - Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62E3B, DBP-62E2B, DBP-62E1B, DBP-61E3, DBP-61E2, DBP-61E1, DBP-61D7G, DBP-6281L, DBP-6282L, DBP-6285L) K252501 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Joytech Healthcare Co. , Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k252831/ 2026-04-28 monthly 0.8 https://www.510kdatabase.net/og-image/k252831-pelvic-floor-treatment-device-dlr-8920-fda-510k.jpg K252831 - Pelvic Floor Treatment Device (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927) K252831 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Dolanvy (Suzhou) Medical Technology Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k253243/ 2026-04-28 monthly 0.8 https://www.510kdatabase.net/og-image/k253243-cardinal-health-poly-reinforced-fda-510k.jpg K253243 - Cardinal Health™ Poly Reinforced Surgical Gown K253243 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cardinal Health 200, LLC. Cleared Apr 2026. https://www.510kdatabase.net/k253940/ 2026-04-28 monthly 0.8 https://www.510kdatabase.net/og-image/k253940-must-pedicle-screw-system-extension-fda-510k.jpg K253940 - M.U.S.T. Pedicle Screw System - Extension K253940 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Apr 2026. https://www.510kdatabase.net/k260065/ 2026-04-28 monthly 0.8 https://www.510kdatabase.net/og-image/k260065-safelife-t-dip-multi-drug-urine-test-fda-510k.jpg K260065 - SAFElife T-Dip Multi-Drug Urine Test Panel K260065 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k260076/ 2026-04-28 monthly 0.8 https://www.510kdatabase.net/og-image/k260076-sam-30-multi-hour-continuous-fda-510k.jpg K260076 - SAM 3.0 Multi-Hour Continuous Ultrasound Device K260076 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: ZetrOZ Systems, LLC. Cleared Apr 2026. https://www.510kdatabase.net/k260121/ 2026-04-28 monthly 0.8 https://www.510kdatabase.net/og-image/k260121-manual-wheelchair-7101l-7102lhd-fda-510k.jpg K260121 - Manual Wheelchair (7101L, 7102LHD) K260121 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Foshan Nanhai Hongchen Medical Equipment Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k260194/ 2026-04-28 monthly 0.8 https://www.510kdatabase.net/og-image/k260194-vacuum-pump-model-ad-vpum-500-fda-510k.jpg K260194 - Vacuum Pump (Model: AD-VPUM-500) K260194 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Sheng Sheng Yi (Beijing) Technology Company Limited. Cleared Apr 2026. https://www.510kdatabase.net/k260248/ 2026-04-28 monthly 0.8 https://www.510kdatabase.net/og-image/k260248-ultra-fast-warm-fda-510k.jpg K260248 - Ultra-Fast Warm K260248 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Kitazato Corporation. Cleared Apr 2026. https://www.510kdatabase.net/k260260/ 2026-04-28 monthly 0.8 https://www.510kdatabase.net/og-image/k260260-automatic-digital-blood-pressure-fda-510k.jpg K260260 - Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569) K260260 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Honsun (Nantong) Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k252409/ 2026-04-27 monthly 0.8 https://www.510kdatabase.net/og-image/k252409-tearcare-mgx-system-fda-510k.jpg K252409 - TearCare MGX System K252409 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Sight Sciences, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k252445/ 2026-04-27 monthly 0.8 https://www.510kdatabase.net/og-image/k252445-fusion-bioline-vascular-graft-fda-510k.jpg K252445 - Fusion Bioline Vascular Graft K252445 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Maquet Cardiovascular, LLC. Cleared Apr 2026. https://www.510kdatabase.net/k252628/ 2026-04-27 monthly 0.8 https://www.510kdatabase.net/og-image/k252628-cassie-fda-510k.jpg K252628 - CASSIE K252628 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Wesper, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k252748/ 2026-04-27 monthly 0.8 https://www.510kdatabase.net/og-image/k252748-pelvic-floor-exerciser-pf01-fda-510k.jpg K252748 - Pelvic Floor Exerciser (PF01) K252748 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hunan Accurate Bio-Medical Technology Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k253658/ 2026-04-27 monthly 0.8 https://www.510kdatabase.net/og-image/k253658-sta-satellite-max-fda-510k.jpg K253658 - STA Satellite Max® K253658 is a FDA 510(k) cleared hematology medical device. Manufacturer: Diagnostica Stago, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k260182/ 2026-04-27 monthly 0.8 https://www.510kdatabase.net/og-image/k260182-avenir-mller-stem-fda-510k.jpg K260182 - Avenir® Müller Stem K260182 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k260660/ 2026-04-27 monthly 0.8 https://www.510kdatabase.net/og-image/k260660-saber-c-system-fda-510k.jpg K260660 - SABER-C System K260660 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Elevation Spine. Cleared Apr 2026. https://www.510kdatabase.net/k261032/ 2026-04-27 monthly 0.8 https://www.510kdatabase.net/og-image/k261032-novoknee-steriknee-fda-510k.jpg K261032 - NovoKnee (SteriKnee) K261032 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: NovoSource. Cleared Apr 2026. https://www.510kdatabase.net/k261356/ 2026-04-27 monthly 0.8 https://www.510kdatabase.net/og-image/k261356-dura-crown-fda-510k.jpg K261356 - Dura-Crown K261356 is a FDA 510(k) cleared dental medical device. Manufacturer: Hangzhou SHINING3D Dental Technology Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k261357/ 2026-04-27 monthly 0.8 https://www.510kdatabase.net/og-image/k261357-grandio-disc-multicolor-fda-510k.jpg K261357 - Grandio disc multicolor K261357 is a FDA 510(k) cleared dental medical device. Manufacturer: Voco GmbH. Cleared Apr 2026. https://www.510kdatabase.net/k253580/ 2026-04-26 monthly 0.8 https://www.510kdatabase.net/og-image/k253580-sterile-insulated-dilators-5-10-16mm-fda-510k.jpg K253580 - Sterile Insulated Dilators, 5, 10, 16mm (MDT-0442S) K253580 is a FDA 510(k) cleared neurology medical device. Manufacturer: Tedan Surgical Innovations. Cleared Apr 2026. https://www.510kdatabase.net/k250234/ 2026-04-24 monthly 0.8 https://www.510kdatabase.net/og-image/k250234-smartez-elastomeric-infusion-pump-rs-fda-510k.jpg K250234 - SMARTeZ™ Elastomeric Infusion Pump (RS series) K250234 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Epic Medical Pte. , Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k250242/ 2026-04-24 monthly 0.8 https://www.510kdatabase.net/og-image/k250242-compression-therapy-device-lgt-2202dvt-fda-510k.jpg K250242 - Compression Therapy Device (LGT-2202DVT) K250242 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Guangzhou Longest Medical Technology Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k250349/ 2026-04-24 monthly 0.8 https://www.510kdatabase.net/og-image/k250349-vista-cms-fda-510k.jpg K250349 - Vista CMS K250349 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shanghai Draeger Medical Instrument Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k252336/ 2026-04-24 monthly 0.8 https://www.510kdatabase.net/og-image/k252336-diazyme-immunoglobulin-a-assay-fda-510k.jpg K252336 - Diazyme Immunoglobulin A Assay K252336 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diazyme Laboratories, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k252337/ 2026-04-24 monthly 0.8 https://www.510kdatabase.net/og-image/k252337-edgeflow-gel-pad-fda-510k.jpg K252337 - EdgeFlow Gel Pad K252337 is a FDA 510(k) cleared radiology medical device. Manufacturer: Edgecare, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k252431/ 2026-04-24 monthly 0.8 https://www.510kdatabase.net/og-image/k252431-elecsys-calcitonin-fda-510k.jpg K252431 - Elecsys Calcitonin K252431 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics GmbH. Cleared Apr 2026. https://www.510kdatabase.net/k252451/ 2026-04-24 monthly 0.8 https://www.510kdatabase.net/og-image/k252451-epore-xo-cup-system-fda-510k.jpg K252451 - EPORE® XO cup system K252451 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Implantcast GmbH. Cleared Apr 2026. https://www.510kdatabase.net/k252492/ 2026-04-24 monthly 0.8 https://www.510kdatabase.net/og-image/k252492-visualized-access-and-delivery-catheter-fda-510k.jpg K252492 - Visualized Access and Delivery Catheter K252492 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Micro-Tech (Nanjing) Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k252810/ 2026-04-24 monthly 0.8 https://www.510kdatabase.net/og-image/k252810-flopatch-fp120-fda-510k.jpg K252810 - FloPatch FP120 K252810 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Flosonics Medical. Cleared Apr 2026. https://www.510kdatabase.net/k253459/ 2026-04-24 monthly 0.8 https://www.510kdatabase.net/og-image/k253459-optis-mobile-next-imaging-system-1014932-fda-510k.jpg K253459 - OPTIS Mobile Next Imaging System (1014932) K253459 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared Apr 2026. https://www.510kdatabase.net/k253805/ 2026-04-24 monthly 0.8 https://www.510kdatabase.net/og-image/k253805-knee-fda-510k.jpg K253805 - Knee+ K253805 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Pixee Medical S.A.S.. Cleared Apr 2026. https://www.510kdatabase.net/k253832/ 2026-04-24 monthly 0.8 https://www.510kdatabase.net/og-image/k253832-dilation-balloon-catheter-fda-510k.jpg K253832 - Dilation Balloon Catheter K253832 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Mirco-Tech (Nanjing) Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k254173/ 2026-04-24 monthly 0.8 https://www.510kdatabase.net/og-image/k254173-artis-icono-floor-fda-510k.jpg K254173 - ARTIS icono floor K254173 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k260009/ 2026-04-24 monthly 0.8 https://www.510kdatabase.net/og-image/k260009-lungpoint-virtual-bronchoscopic-fda-510k.jpg K260009 - LungPoint Virtual Bronchoscopic Navigation (VBN) Software K260009 is a FDA 510(k) cleared radiology medical device. Manufacturer: Broncus Medical, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k260054/ 2026-04-24 monthly 0.8 https://www.510kdatabase.net/og-image/k260054-its-prs-phoenix-ii-fda-510k.jpg K260054 - I.T.S. PRS Phoenix II K260054 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: I.T.S. GmbH. Cleared Apr 2026. https://www.510kdatabase.net/k260228/ 2026-04-24 monthly 0.8 https://www.510kdatabase.net/og-image/k260228-poya-35mm-medial-proximal-tibia-system-fda-510k.jpg K260228 - POYA 3.5mm Medial Proximal Tibia System K260228 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Bonebridge AG. Cleared Apr 2026. https://www.510kdatabase.net/k260411/ 2026-04-24 monthly 0.8 https://www.510kdatabase.net/og-image/k260411-pc-fix-system-fda-510k.jpg K260411 - PC Fix System K260411 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Chest Wall Innovations, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k260429/ 2026-04-24 monthly 0.8 https://www.510kdatabase.net/og-image/k260429-control-iq-technology-fda-510k.jpg K260429 - Control-IQ+ technology K260429 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Tandem Diabetes Care, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k260549/ 2026-04-24 monthly 0.8 https://www.510kdatabase.net/og-image/k260549-zsfab-cervical-interbody-system-and-fda-510k.jpg K260549 - ZSFab Cervical Interbody System and ZSFab Lumbar Interbody System K260549 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zsfab, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k260599/ 2026-04-24 monthly 0.8 https://www.510kdatabase.net/og-image/k260599-indigo-aspiration-system-indigo-link-fda-510k.jpg K260599 - INDIGO® Aspiration System – INDIGO Link K260599 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Penumbra, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k260982/ 2026-04-24 monthly 0.8 https://www.510kdatabase.net/og-image/k260982-alexis-lighted-wound-protector-fda-510k.jpg K260982 - Alexis lighted wound protector-retractor, flexible, extra small (cl312) K260982 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Applied Medical Resources Corporation. Cleared Apr 2026. https://www.510kdatabase.net/k260988/ 2026-04-24 monthly 0.8 https://www.510kdatabase.net/og-image/k260988-m-warmer-system-with-m-station-fda-510k.jpg K260988 - °M Warmer System with °M Station K260988 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Mequ A/S. Cleared Apr 2026. https://www.510kdatabase.net/k260993/ 2026-04-24 monthly 0.8 https://www.510kdatabase.net/og-image/k260993-amplatzer-torqvue-delivery-system-fda-510k.jpg K260993 - Amplatzer TorqVue Delivery System K260993 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott. Cleared Apr 2026. https://www.510kdatabase.net/k260999/ 2026-04-24 monthly 0.8 https://www.510kdatabase.net/og-image/k260999-lofric-elle-pro-fda-510k.jpg K260999 - LoFric Elle Pro K260999 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Wellspect AB. Cleared Apr 2026. https://www.510kdatabase.net/k261008/ 2026-04-24 monthly 0.8 https://www.510kdatabase.net/og-image/k261008-vitoss-bimodal-bioactive-bone-graft-fda-510k.jpg K261008 - Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip K261008 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Spine. Cleared Apr 2026. https://www.510kdatabase.net/k261043/ 2026-04-24 monthly 0.8 https://www.510kdatabase.net/og-image/k261043-autobahn-nailing-system-fda-510k.jpg K261043 - AUTOBAHN™ Nailing System K261043 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k252341/ 2026-04-23 monthly 0.8 https://www.510kdatabase.net/og-image/k252341-evis-exera-iii-bronchovideoscope-fda-510k.jpg K252341 - EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-Q190) K252341 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Apr 2026. https://www.510kdatabase.net/k252389/ 2026-04-23 monthly 0.8 https://www.510kdatabase.net/og-image/k252389-rhythm-master-ecg-patch-hm-15bb-ax-hm-fda-510k.jpg K252389 - Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX) K252389 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Smwmed, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k252407/ 2026-04-23 monthly 0.8 https://www.510kdatabase.net/og-image/k252407-oxygo-portable-oxygen-concentrator-fda-510k.jpg K252407 - OxyGo Portable Oxygen Concentrator (1400-7000) K252407 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Mv Life, LLC. Cleared Apr 2026. https://www.510kdatabase.net/k252436/ 2026-04-23 monthly 0.8 https://www.510kdatabase.net/og-image/k252436-tula-tympanostomy-tube-delivery-device-fda-510k.jpg K252436 - Tula Tympanostomy Tube Delivery Device K252436 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Tusker Medical, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k252815/ 2026-04-23 monthly 0.8 https://www.510kdatabase.net/og-image/k252815-probeam-360-proton-therapy-system-v30-fda-510k.jpg K252815 - ProBeam 360 Proton Therapy System v3.0 K252815 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k253589/ 2026-04-23 monthly 0.8 https://www.510kdatabase.net/og-image/k253589-liberant-rx-aspiration-catheter-fda-510k.jpg K253589 - Liberant™ RX Aspiration Catheter K253589 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Interventional Vascular, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k253752/ 2026-04-23 monthly 0.8 https://www.510kdatabase.net/og-image/k253752-artis-genio-floor-fda-510k.jpg K253752 - ARTIS genio floor K253752 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k254237/ 2026-04-23 monthly 0.8 https://www.510kdatabase.net/og-image/k254237-cci-pacs-viewer-pacs-us-001-fda-510k.jpg K254237 - CCI PACS VIEWER (PACS-US-001) K254237 is a FDA 510(k) cleared radiology medical device. Manufacturer: CliniComp, Intl.. Cleared Apr 2026. https://www.510kdatabase.net/k254248/ 2026-04-23 monthly 0.8 https://www.510kdatabase.net/og-image/k254248-introducer-sheath-set-fda-510k.jpg K254248 - Introducer Sheath Set K254248 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cardiocycle Medical(Suzhou) Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k260152/ 2026-04-23 monthly 0.8 https://www.510kdatabase.net/og-image/k260152-smart-print-bio-vitality-a2-a3-bl1-b1-fda-510k.jpg K260152 - Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT) K260152 is a FDA 510(k) cleared dental medical device. Manufacturer: Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda.. Cleared Apr 2026. https://www.510kdatabase.net/k260195/ 2026-04-23 monthly 0.8 https://www.510kdatabase.net/og-image/k260195-elongated-one-piece-arterial-eopa-3d-fda-510k.jpg K260195 - Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae K260195 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k260320/ 2026-04-23 monthly 0.8 https://www.510kdatabase.net/og-image/k260320-lunit-insight-mmg-v1110-fda-510k.jpg K260320 - Lunit INSIGHT MMG (v1.1.10) K260320 is a FDA 510(k) cleared radiology medical device. Manufacturer: Lunit, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k260785/ 2026-04-23 monthly 0.8 https://www.510kdatabase.net/og-image/k260785-ds-core-cbct-anatomy-fda-510k.jpg K260785 - DS Core CBCT Anatomy K260785 is a FDA 510(k) cleared radiology medical device. Manufacturer: Dentsply Sirona. Cleared Apr 2026. https://www.510kdatabase.net/k260947/ 2026-04-23 monthly 0.8 https://www.510kdatabase.net/og-image/k260947-055t-12ch-breast-coil-fda-510k.jpg K260947 - 0.55T 12Ch Breast Coil K260947 is a FDA 510(k) cleared radiology medical device. Manufacturer: Neocoil, LLC. Cleared Apr 2026. https://www.510kdatabase.net/k260976/ 2026-04-23 monthly 0.8 https://www.510kdatabase.net/og-image/k260976-neuroblate-system-fda-510k.jpg K260976 - NeuroBlate System K260976 is a FDA 510(k) cleared neurology medical device. Manufacturer: Monteris Medical,. Cleared Apr 2026. https://www.510kdatabase.net/k261012/ 2026-04-23 monthly 0.8 https://www.510kdatabase.net/og-image/k261012-optimap-catheter-60mm-opti-cath2-60-fda-510k.jpg K261012 - OptiMap Catheter - 60mm (OPTI-CATH2-60) K261012 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cortex, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k252306/ 2026-04-22 monthly 0.8 https://www.510kdatabase.net/og-image/k252306-verrix-eva-steam-biological-indicator-fda-510k.jpg K252306 - Verrix EVA™ STEAM Biological Indicator (BI) (Model: 1200), Verrix EVA™ STEAM Process Challenge Device (PCD) (Model: 1300) combined with Verrix EVA™ Auto-Reader (Model: 1100) K252306 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Steritec Products. Cleared Apr 2026. https://www.510kdatabase.net/k253077/ 2026-04-22 monthly 0.8 https://www.510kdatabase.net/og-image/k253077-uomnispacemr-fda-510k.jpg K253077 - uOmnispace.MR K253077 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k253163/ 2026-04-22 monthly 0.8 https://www.510kdatabase.net/og-image/k253163-efai-ersuite-ct-appendicitis-fda-510k.jpg K253163 - EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100) K253163 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ever Fortune.Ai, Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k253230/ 2026-04-22 monthly 0.8 https://www.510kdatabase.net/og-image/k253230-erbecryo-2-cryosurgical-unit-and-fda-510k.jpg K253230 - ERBECRYO 2 Cryosurgical Unit and Accessories: ERBECRYO 2 cryosurgical unit K253230 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Erbe Elektromedizin GmbH. Cleared Apr 2026. https://www.510kdatabase.net/k253256/ 2026-04-22 monthly 0.8 https://www.510kdatabase.net/og-image/k253256-myosmart-13e522-fda-510k.jpg K253256 - myosmart. (13E522) K253256 is a FDA 510(k) cleared neurology medical device. Manufacturer: Otto Bock Healthcare Products GmbH. Cleared Apr 2026. https://www.510kdatabase.net/k253765/ 2026-04-22 monthly 0.8 https://www.510kdatabase.net/og-image/k253765-vanish-pro-fda-510k.jpg K253765 - VANISH PRO K253765 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ddc Technologies, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k260150/ 2026-04-22 monthly 0.8 https://www.510kdatabase.net/og-image/k260150-led-facial-mask-mj-66db-mk-99-mk-99a-fda-510k.jpg K260150 - LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C) K260150 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: NOOANCE. Cleared Apr 2026. https://www.510kdatabase.net/k260237/ 2026-04-22 monthly 0.8 https://www.510kdatabase.net/og-image/k260237-mobility-scooter-x-12-x-14-x-17-fda-510k.jpg K260237 - Mobility Scooter (X-12, X-14, X-17) K260237 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Wuyi Aichi Industry and Trade Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k260239/ 2026-04-22 monthly 0.8 https://www.510kdatabase.net/og-image/k260239-wearable-breast-pump-aov6853-aov6860-fda-510k.jpg K260239 - Wearable Breast Pump (AOV6853, AOV6860, AOV6861, AOV6862) K260239 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Jiangxi AOV Maternity & Baby Products Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k260570/ 2026-04-22 monthly 0.8 https://www.510kdatabase.net/og-image/k260570-corra-cervical-plating-system-fda-510k.jpg K260570 - corra™ cervical plating system K260570 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Carlsmed, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k250793/ 2026-04-21 monthly 0.8 https://www.510kdatabase.net/og-image/k250793-rhythmstar-system-sl-fda-510k.jpg K250793 - RhythmStar System (SL) K250793 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: RhythMedix, LLC. Cleared Apr 2026. https://www.510kdatabase.net/k253982/ 2026-04-21 monthly 0.8 https://www.510kdatabase.net/og-image/k253982-korotkoff-sound-blood-pressure-monitor-fda-510k.jpg K253982 - Korotkoff sound blood pressure monitor K253982 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Beijing Hanvon Health Technology Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k254046/ 2026-04-21 monthly 0.8 https://www.510kdatabase.net/og-image/k254046-boscath-support-catheter-fda-510k.jpg K254046 - BosCATH Support Catheter K254046 is a FDA 510(k) cleared neurology medical device. Manufacturer: Sonorous NV, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k260216/ 2026-04-21 monthly 0.8 https://www.510kdatabase.net/og-image/k260216-cd-horizon-modulex-fenestrated-screw-set-fda-510k.jpg K260216 - CD Horizon™ ModuLeX™ Fenestrated Screw Set K260216 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k260447/ 2026-04-21 monthly 0.8 https://www.510kdatabase.net/og-image/k260447-etest-gepotidacin-gep-0016-256-gml-fda-510k.jpg K260447 - ETEST Gepotidacin (GEP) (0.016-256 µg/mL) K260447 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Biom?rieux SA. Cleared Apr 2026. https://www.510kdatabase.net/k260518/ 2026-04-21 monthly 0.8 https://www.510kdatabase.net/og-image/k260518-ipl-hair-removal-sl-b301-sl-b300-sl-fda-510k.jpg K260518 - IPL Hair Removal (SL-B301, SL-B300, SL-B330, SL-B330-1, SL-B287-1, SL-B371, SL-B371-2, SL-B371-1, SL-B352, SL-B352-1, SL-B352-2, SL-B330-F) K260518 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Semlamp Intelligent Technology Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k260573/ 2026-04-21 monthly 0.8 https://www.510kdatabase.net/og-image/k260573-evoendo-single-use-endoscopy-system-fda-510k.jpg K260573 - EvoEndo Single-Use Endoscopy System K260573 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: EvoEndo, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k260921/ 2026-04-21 monthly 0.8 https://www.510kdatabase.net/og-image/k260921-tigon-medical-static-javelin-all-fda-510k.jpg K260921 - Tigon Medical Static Javelin All-Suture Anchors & Javelin All-Suture Anchor Line K260921 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tigon Medical. Cleared Apr 2026. https://www.510kdatabase.net/k242163/ 2026-04-20 monthly 0.8 https://www.510kdatabase.net/og-image/k242163-smartsurgn-visualization-system-fda-510k.jpg K242163 - SmartSurgN Visualization System K242163 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smartsurgn, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k252332/ 2026-04-20 monthly 0.8 https://www.510kdatabase.net/og-image/k252332-folliscan-fda-510k.jpg K252332 - Folliscan K252332 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mim Fertility. Cleared Apr 2026. https://www.510kdatabase.net/k252718/ 2026-04-20 monthly 0.8 https://www.510kdatabase.net/og-image/k252718-lunar-astra-fda-510k.jpg K252718 - Lunar Astra K252718 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. Cleared Apr 2026. https://www.510kdatabase.net/k253003/ 2026-04-20 monthly 0.8 https://www.510kdatabase.net/og-image/k253003-non-sterile-level-3-surgical-gown-4025-fda-510k.jpg K253003 - Non-sterile Level 3 Surgical Gown (4025) K253003 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hubei Xinxin Non-Woven Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k253213/ 2026-04-20 monthly 0.8 https://www.510kdatabase.net/og-image/k253213-sagi-cervical-cage-system-fda-510k.jpg K253213 - SAGI Cervical Cage System K253213 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: ZheJiang Decans Medical Devices Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k253558/ 2026-04-20 monthly 0.8 https://www.510kdatabase.net/og-image/k253558-luminoah-flow-enteral-nutrition-system-fda-510k.jpg K253558 - Luminoah FLOW™ Enteral Nutrition System K253558 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Luminoah. Cleared Apr 2026. https://www.510kdatabase.net/k253638/ 2026-04-20 monthly 0.8 https://www.510kdatabase.net/og-image/k253638-xstep-xstep-fda-510k.jpg K253638 - xStep (xStep) K253638 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Spinex, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k253806/ 2026-04-20 monthly 0.8 https://www.510kdatabase.net/og-image/k253806-power-wheelchair-n5919-series-fda-510k.jpg K253806 - Power Wheelchair (N5919 series) K253806 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zhejiang Innuovo Rehabilitation Devices Co.,Ltd. Cleared Apr 2026. https://www.510kdatabase.net/k260153/ 2026-04-20 monthly 0.8 https://www.510kdatabase.net/og-image/k260153-q-switched-nd-yag-laser-system-glamor-q-fda-510k.jpg K260153 - Q-Switched Nd: YAG Laser System (Glamor Q) K260153 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Nanjing Bestview Laser S&T Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k260212/ 2026-04-20 monthly 0.8 https://www.510kdatabase.net/og-image/k260212-ensite-x-ep-system-fda-510k.jpg K260212 - EnSite™ X EP System K260212 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared Apr 2026. https://www.510kdatabase.net/k252237/ 2026-04-17 monthly 0.8 https://www.510kdatabase.net/og-image/k252237-edgeflow-uw20-fda-510k.jpg K252237 - EdgeFlow UW20 K252237 is a FDA 510(k) cleared radiology medical device. Manufacturer: Edgecare, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k252279/ 2026-04-17 monthly 0.8 https://www.510kdatabase.net/og-image/k252279-sterile-hypodermic-syringe-for-single-fda-510k.jpg K252279 - Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) K252279 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Chirana T.Injecta,A.S.. Cleared Apr 2026. https://www.510kdatabase.net/k252334/ 2026-04-17 monthly 0.8 https://www.510kdatabase.net/og-image/k252334-pelvipower-pelvic-functional-magnetic-fda-510k.jpg K252334 - PELVIPOWER Pelvic Functional Magnetic Stimulation (PELVIPOWER PelvicFMS) (033-0-1100-02) K252334 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Pontemedag. Cleared Apr 2026. https://www.510kdatabase.net/k252338/ 2026-04-17 monthly 0.8 https://www.510kdatabase.net/og-image/k252338-mysleepdash-fda-510k.jpg K252338 - MySleepDash K252338 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Somnetics International, Inc. (Dba Transcend Inc). Cleared Apr 2026. https://www.510kdatabase.net/k252945/ 2026-04-17 monthly 0.8 https://www.510kdatabase.net/og-image/k252945-novasight-hybrid-system-fda-510k.jpg K252945 - Novasight Hybrid System K252945 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Conavi Medical, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k253970/ 2026-04-17 monthly 0.8 https://www.510kdatabase.net/og-image/k253970-wovyn-depth-electrode-fda-510k.jpg K253970 - Wovyn Depth Electrode K253970 is a FDA 510(k) cleared neurology medical device. Manufacturer: Sensomedical Labs, Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k254279/ 2026-04-17 monthly 0.8 https://www.510kdatabase.net/og-image/k254279-edwards-esheath-introducer-set-fda-510k.jpg K254279 - Edwards eSheath+ introducer set K254279 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences. Cleared Apr 2026. https://www.510kdatabase.net/k260696/ 2026-04-17 monthly 0.8 https://www.510kdatabase.net/og-image/k260696-mts-gepotidacin-0016-256-gml-fda-510k.jpg K260696 - MTS Gepotidacin 0.016-256 µg/mL K260696 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Liofilchem S. R. L.. Cleared Apr 2026. https://www.510kdatabase.net/k260900/ 2026-04-17 monthly 0.8 https://www.510kdatabase.net/og-image/k260900-dynex-external-fixation-systems-fda-510k.jpg K260900 - DYNEX® External Fixation Systems K260900 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Vilex, LLC. Cleared Apr 2026. https://www.510kdatabase.net/k260929/ 2026-04-17 monthly 0.8 https://www.510kdatabase.net/og-image/k260929-neonav-ecg-tip-location-system-fda-510k.jpg K260929 - Neonav ECG Tip Location System K260929 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Navi Medical Technologies. Cleared Apr 2026. https://www.510kdatabase.net/k260934/ 2026-04-17 monthly 0.8 https://www.510kdatabase.net/og-image/k260934-titan-nail-fda-510k.jpg K260934 - TITAN Nail K260934 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medartis AG. Cleared Apr 2026. https://www.510kdatabase.net/k261261/ 2026-04-17 monthly 0.8 https://www.510kdatabase.net/og-image/k261261-dura-arch-fda-510k.jpg K261261 - Dura-Arch K261261 is a FDA 510(k) cleared dental medical device. Manufacturer: Hangzhou SHINING3D Dental Technology Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/den250033/ 2026-04-17 monthly 0.8 https://www.510kdatabase.net/og-image/den250033-xplantr-explant-tool-fda-510k.jpg DEN250033 - XplantR Explant Tool DEN250033 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hjarta Care, LLC. Cleared Apr 2026. https://www.510kdatabase.net/k251478/ 2026-04-16 monthly 0.8 https://www.510kdatabase.net/og-image/k251478-cleartip-tbna-type-fda-510k.jpg K251478 - ClearTip TBNA Type K251478 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Finemedix Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k251658/ 2026-04-16 monthly 0.8 https://www.510kdatabase.net/og-image/k251658-endoflux-biliary-pancreatic-stent-sets-fda-510k.jpg K251658 - Endoflux™ Biliary & Pancreatic Stent Sets K251658 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medi-Globe GmbH. Cleared Apr 2026. https://www.510kdatabase.net/k252317/ 2026-04-16 monthly 0.8 https://www.510kdatabase.net/og-image/k252317-zenith-micro-guidewire-fda-510k.jpg K252317 - Zenith Micro Guidewire K252317 is a FDA 510(k) cleared neurology medical device. Manufacturer: Suzhou Zenith Vascular SciTech Limited. Cleared Apr 2026. https://www.510kdatabase.net/k252318/ 2026-04-16 monthly 0.8 https://www.510kdatabase.net/og-image/k252318-insufflator-opto-ifl1000-fda-510k.jpg K252318 - Insufflator (OPTO-IFL1000) K252318 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Guangdong Optomedic Technologies, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k253048/ 2026-04-16 monthly 0.8 https://www.510kdatabase.net/og-image/k253048-high-pressure-syringe-fda-510k.jpg K253048 - High Pressure Syringe K253048 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen Maiwei Biotech Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k253170/ 2026-04-16 monthly 0.8 https://www.510kdatabase.net/og-image/k253170-umec-60-umec-70-umec-80umec-100umec-fda-510k.jpg K253170 - uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient Monitors K253170 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k253260/ 2026-04-16 monthly 0.8 https://www.510kdatabase.net/og-image/k253260-orio-3d-cage-system-fda-510k.jpg K253260 - ORIO-3D Cage System K253260 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SpineCraft. Cleared Apr 2026. https://www.510kdatabase.net/k253523/ 2026-04-16 monthly 0.8 https://www.510kdatabase.net/og-image/k253523-freedom-ds-decompression-system-fda-510k.jpg K253523 - Freedom DS™ Decompression System K253523 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinal Simplicity. Cleared Apr 2026. https://www.510kdatabase.net/k253537/ 2026-04-16 monthly 0.8 https://www.510kdatabase.net/og-image/k253537-glean-urodynamics-system-male-delivery-fda-510k.jpg K253537 - Glean Urodynamics System Male Delivery System (GUS-1000-M) K253537 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Bright Uro, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k253804/ 2026-04-16 monthly 0.8 https://www.510kdatabase.net/og-image/k253804-dess-dental-smart-solutions-fda-510k.jpg K253804 - DESS Dental Smart Solutions K253804 is a FDA 510(k) cleared dental medical device. Manufacturer: Terrats Medical SL. Cleared Apr 2026. https://www.510kdatabase.net/k253892/ 2026-04-16 monthly 0.8 https://www.510kdatabase.net/og-image/k253892-strauss-surgical-cystoscopes-fda-510k.jpg K253892 - Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, 4 x 302 mm, view. Dir. 0°, standard, autoclavable) K253892 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Strauss Surgical USA. Cleared Apr 2026. https://www.510kdatabase.net/k253907/ 2026-04-16 monthly 0.8 https://www.510kdatabase.net/og-image/k253907-disposable-radiofrequency-cannula-fda-510k.jpg K253907 - Disposable Radiofrequency Cannula K253907 is a FDA 510(k) cleared neurology medical device. Manufacturer: Abbott Medical. Cleared Apr 2026. https://www.510kdatabase.net/k254101/ 2026-04-16 monthly 0.8 https://www.510kdatabase.net/og-image/k254101-julva-velv-water-based-personal-fda-510k.jpg K254101 - Julva Velvé Water-Based Personal Lubricant K254101 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Golden Isles Medical, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k254216/ 2026-04-16 monthly 0.8 https://www.510kdatabase.net/og-image/k254216-enso-for-migraine-fda-510k.jpg K254216 - Enso for Migraine K254216 is a FDA 510(k) cleared neurology medical device. Manufacturer: Hinge Health, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k254223/ 2026-04-16 monthly 0.8 https://www.510kdatabase.net/og-image/k254223-next-generation-088-catheter-fda-510k.jpg K254223 - Next Generation 088 Catheter K254223 is a FDA 510(k) cleared neurology medical device. Manufacturer: Balt USA, LLC. Cleared Apr 2026. https://www.510kdatabase.net/k254273/ 2026-04-16 monthly 0.8 https://www.510kdatabase.net/og-image/k254273-verisafe-safety-sterile-needles-ssn-fda-510k.jpg K254273 - Verisafe Safety Sterile Needles (SSN) K254273 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Promisemed Hangzhou Meditech Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k254274/ 2026-04-16 monthly 0.8 https://www.510kdatabase.net/og-image/k254274-arx-sai-implant-system-fda-510k.jpg K254274 - ARx® SAI Implant System K254274 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k260011/ 2026-04-16 monthly 0.8 https://www.510kdatabase.net/og-image/k260011-foundation-surgical-navigated-lateral-fda-510k.jpg K260011 - Foundation Surgical Navigated Lateral Disc Prep Instruments K260011 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Foundation Surgical Group, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k260020/ 2026-04-16 monthly 0.8 https://www.510kdatabase.net/og-image/k260020-redermo-wound-matrix-fda-510k.jpg K260020 - Redermo Wound Matrix K260020 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Beijing Kreate Medical Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k260903/ 2026-04-16 monthly 0.8 https://www.510kdatabase.net/og-image/k260903-hot-pink-pad-warming-system-fda-510k.jpg K260903 - Hot Pink Pad Warming System K260903 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Xodus Medical, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k252258/ 2026-04-15 monthly 0.8 https://www.510kdatabase.net/og-image/k252258-veriqa-rt-epid-3d-fda-510k.jpg K252258 - VERIQA RT EPID 3D K252258 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla. Cleared Apr 2026. https://www.510kdatabase.net/k252404/ 2026-04-15 monthly 0.8 https://www.510kdatabase.net/og-image/k252404-comprehensive-reverse-shoulder-ha-fda-510k.jpg K252404 - Comprehensive Reverse Shoulder - HA Glenosphere Baseplates K252404 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet Orthopedics. Cleared Apr 2026. https://www.510kdatabase.net/k252728/ 2026-04-15 monthly 0.8 https://www.510kdatabase.net/og-image/k252728-ids-isys-total-testosterone-fda-510k.jpg K252728 - IDS-iSYS Total Testosterone K252728 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Immunodiagnostic Systems Limited. Cleared Apr 2026. https://www.510kdatabase.net/k252774/ 2026-04-15 monthly 0.8 https://www.510kdatabase.net/og-image/k252774-uni-c-cervical-cage-system-fda-510k.jpg K252774 - Uni-C Cervical Cage System K252774 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: ZheJiang Decans Medical Devices Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k252843/ 2026-04-15 monthly 0.8 https://www.510kdatabase.net/og-image/k252843-sterrad-100nx-sterilization-system-fda-510k.jpg K252843 - STERRAD 100NX Sterilization System with ALLClear Technology (10104) K252843 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Advanced Sterilization Products, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k253337/ 2026-04-15 monthly 0.8 https://www.510kdatabase.net/og-image/k253337-regen-bioactive-cement-fda-510k.jpg K253337 - REGEN Bioactive Cement K253337 is a FDA 510(k) cleared dental medical device. Manufacturer: Inter-Med, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k253573/ 2026-04-15 monthly 0.8 https://www.510kdatabase.net/og-image/k253573-astar-bc-g-kit-fda-510k.jpg K253573 - ASTar BC G- Kit K253573 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Q-Linea AB. Cleared Apr 2026. https://www.510kdatabase.net/k254107/ 2026-04-15 monthly 0.8 https://www.510kdatabase.net/og-image/k254107-refobacin-bone-cement-r-110034355-fda-510k.jpg K254107 - Refobacin Bone Cement R (110034355) K254107 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet France. Cleared Apr 2026. https://www.510kdatabase.net/k260128/ 2026-04-15 monthly 0.8 https://www.510kdatabase.net/og-image/k260128-bd-preset-and-bd-a-line-arterial-blood-fda-510k.jpg K260128 - BD Preset™ and BD A-Line™ Arterial Blood Collection Syringes K260128 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Becton, Dickinson and Company. Cleared Apr 2026. https://www.510kdatabase.net/k260129/ 2026-04-15 monthly 0.8 https://www.510kdatabase.net/og-image/k260129-lumaflex-panel-zld-05-zld-05a-zld-05apro-fda-510k.jpg K260129 - Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) K260129 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Kaiyan Medical Equipment Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k260282/ 2026-04-15 monthly 0.8 https://www.510kdatabase.net/og-image/k260282-vitek-2-ast-streptococcus-inducible-fda-510k.jpg K260282 - VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance K260282 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k260307/ 2026-04-15 monthly 0.8 https://www.510kdatabase.net/og-image/k260307-diode-laser-therapy-systems-v19-fda-510k.jpg K260307 - Diode Laser Therapy Systems (V19) K260307 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Weifang Mingliang Electronics Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k260661/ 2026-04-15 monthly 0.8 https://www.510kdatabase.net/og-image/k260661-midas-restore-fda-510k.jpg K260661 - Midas Restore K260661 is a FDA 510(k) cleared dental medical device. Manufacturer: Sprintray, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k260722/ 2026-04-15 monthly 0.8 https://www.510kdatabase.net/og-image/k260722-suresmile-aligner-assy500020-fda-510k.jpg K260722 - SureSmile Aligner (ASSY500020) K260722 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k260938/ 2026-04-15 monthly 0.8 https://www.510kdatabase.net/og-image/k260938-path-bgc-fda-510k.jpg K260938 - PATH BGC K260938 is a FDA 510(k) cleared neurology medical device. Manufacturer: Crossroads Neurovascular, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k252587/ 2026-04-14 monthly 0.8 https://www.510kdatabase.net/og-image/k252587-hd-8ch-wrist-array-fda-510k.jpg K252587 - HD 8Ch Wrist Array K252587 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen RF Tech Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k252663/ 2026-04-14 monthly 0.8 https://www.510kdatabase.net/og-image/k252663-inbentus-versatile-fda-510k.jpg K252663 - Inbentus Versatile K252663 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Iconic Solutions by Murcia, SL. Cleared Apr 2026. https://www.510kdatabase.net/k253107/ 2026-04-14 monthly 0.8 https://www.510kdatabase.net/og-image/k253107-electric-nasal-aspirator-dt10-and-dt50-fda-510k.jpg K253107 - Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90) K253107 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Shenzhen Dongjiang Technology Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k253502/ 2026-04-14 monthly 0.8 https://www.510kdatabase.net/og-image/k253502-critical-care-suite-with-enteric-tube-fda-510k.jpg K253502 - Critical Care Suite with Enteric Tube Positioning AI Algorithm K253502 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems, LLC. Cleared Apr 2026. https://www.510kdatabase.net/k260498/ 2026-04-14 monthly 0.8 https://www.510kdatabase.net/og-image/k260498-trimemo-semirigid-annuloplasty-ring-fda-510k.jpg K260498 - TriMemo™ SEMIRIGID ANNULOPLASTY RING K260498 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Corcym S.r.l.. Cleared Apr 2026. https://www.510kdatabase.net/k260583/ 2026-04-14 monthly 0.8 https://www.510kdatabase.net/og-image/k260583-equinoxe-shoulder-system-fda-510k.jpg K260583 - Equinoxe® Shoulder System K260583 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k260931/ 2026-04-14 monthly 0.8 https://www.510kdatabase.net/og-image/k260931-unimed-reusable-finger-clip-spo2-fda-510k.jpg K260931 - Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R) K260931 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Unimed Medical Supplies, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k252280/ 2026-04-13 monthly 0.8 https://www.510kdatabase.net/og-image/k252280-elecsys-anti-sars-cov-2-s-fda-510k.jpg K252280 - Elecsys Anti-SARS-CoV-2 S K252280 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Diagnostics. Cleared Apr 2026. https://www.510kdatabase.net/k253357/ 2026-04-13 monthly 0.8 https://www.510kdatabase.net/og-image/k253357-b-one-bipolar-head-fda-510k.jpg K253357 - b-ONE® Bipolar Head K253357 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: B-One Ortho, Corp.. Cleared Apr 2026. https://www.510kdatabase.net/k253592/ 2026-04-13 monthly 0.8 https://www.510kdatabase.net/og-image/k253592-zimmer-biomet-reverse-shoulder-fda-510k.jpg K253592 - Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter) K253592 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k253861/ 2026-04-13 monthly 0.8 https://www.510kdatabase.net/og-image/k253861-acorys-mapping-system-fda-510k.jpg K253861 - ACORYS MAPPING SYSTEM K253861 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Corify Care S.L. Cleared Apr 2026. https://www.510kdatabase.net/k254078/ 2026-04-13 monthly 0.8 https://www.510kdatabase.net/og-image/k254078-hvt-20-fda-510k.jpg K254078 - HVT 2.0 K254078 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Vapotherm, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k254128/ 2026-04-13 monthly 0.8 https://www.510kdatabase.net/og-image/k254128-inset-reverse-total-shoulder-system-fda-510k.jpg K254128 - InSet Reverse Total Shoulder System K254128 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Shoulder Innovations, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k260091/ 2026-04-13 monthly 0.8 https://www.510kdatabase.net/og-image/k260091-aventus-introducer-sheath-fda-510k.jpg K260091 - Aventus Introducer Sheath K260091 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inquis Medical. Cleared Apr 2026. https://www.510kdatabase.net/k260095/ 2026-04-13 monthly 0.8 https://www.510kdatabase.net/og-image/k260095-heal-check-rapid-covid-19-antigen-self-fda-510k.jpg K260095 - Heal-Check Rapid COVID-19 Antigen Self-Test K260095 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Healgen Scientific, LLC. Cleared Apr 2026. https://www.510kdatabase.net/k260340/ 2026-04-13 monthly 0.8 https://www.510kdatabase.net/og-image/k260340-hc-biologics-osteopoint-peek-cages-hc-fda-510k.jpg K260340 - HC BIOLOGICS OSTEOPOINT PEEK CAGES, HC BIOLOGICS OSTEOPOINT CERVICAL PEEK CAGES, HC BIOLOGICS OSTEOPOINT LUMBAR PEEK CAGES K260340 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: HC Biologics, LLC. Cleared Apr 2026. https://www.510kdatabase.net/k260965/ 2026-04-13 monthly 0.8 https://www.510kdatabase.net/og-image/k260965-cvac-aspiration-system-fda-510k.jpg K260965 - CVAC Aspiration System K260965 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Calyxo, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k252190/ 2026-04-10 monthly 0.8 https://www.510kdatabase.net/og-image/k252190-deepbt-detector-plus-fda-510k.jpg K252190 - DeepBT Detector-Plus K252190 is a FDA 510(k) cleared radiology medical device. Manufacturer: Aitewan Biomedical Technology, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k252207/ 2026-04-10 monthly 0.8 https://www.510kdatabase.net/og-image/k252207-abl90-flex-plus-system-safeclinitubes-fda-510k.jpg K252207 - ABL90 FLEX PLUS System, safeCLINITUBES K252207 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Radiometer Medicals Aps. Cleared Apr 2026. https://www.510kdatabase.net/k252241/ 2026-04-10 monthly 0.8 https://www.510kdatabase.net/og-image/k252241-pressio-3-multi-parameter-fda-510k.jpg K252241 - Pressio 3 Multi-parameter Neuromonitoring System K252241 is a FDA 510(k) cleared neurology medical device. Manufacturer: Sophysa. Cleared Apr 2026. https://www.510kdatabase.net/k252250/ 2026-04-10 monthly 0.8 https://www.510kdatabase.net/og-image/k252250-vista-300vista-300-s-fda-510k.jpg K252250 - Vista 300/Vista 300 S K252250 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shanghai Draeger Medical Instrument Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k252378/ 2026-04-10 monthly 0.8 https://www.510kdatabase.net/og-image/k252378-bd-minidraw-capillary-blood-collection-fda-510k.jpg K252378 - BD® MiniDraw™ Capillary Blood Collection System with BD® MiniDraw™ SST™ Capillary Blood Collection Tube K252378 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Becton, Dickinson and Company. Cleared Apr 2026. https://www.510kdatabase.net/k252485/ 2026-04-10 monthly 0.8 https://www.510kdatabase.net/og-image/k252485-clenchnomore-cnm-1-mixed-sizing-fda-510k.jpg K252485 - ClenchNoMore (CNM-1 (Mixed sizing)) K252485 is a FDA 510(k) cleared dental medical device. Manufacturer: 1987 Media Limited. Cleared Apr 2026. https://www.510kdatabase.net/k252506/ 2026-04-10 monthly 0.8 https://www.510kdatabase.net/og-image/k252506-bd-vacutainer-safety-lok-blood-fda-510k.jpg K252506 - BD Vacutainer® Safety-Lok™ Blood Collection Set K252506 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson and Company. Cleared Apr 2026. https://www.510kdatabase.net/k252548/ 2026-04-10 monthly 0.8 https://www.510kdatabase.net/og-image/k252548-ai-rad-companion-organs-rt-fda-510k.jpg K252548 - AI-Rad Companion Organs RT K252548 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Healthcare GmbH. Cleared Apr 2026. https://www.510kdatabase.net/k252699/ 2026-04-10 monthly 0.8 https://www.510kdatabase.net/og-image/k252699-coaptix-s-system-fda-510k.jpg K252699 - CoAptix S System K252699 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: University of Utah, Department of Orthopaedics. Cleared Apr 2026. https://www.510kdatabase.net/k252708/ 2026-04-10 monthly 0.8 https://www.510kdatabase.net/og-image/k252708-relu-cloud-fda-510k.jpg K252708 - Relu Cloud K252708 is a FDA 510(k) cleared dental medical device. Manufacturer: Relu BV. Cleared Apr 2026. https://www.510kdatabase.net/k252757/ 2026-04-10 monthly 0.8 https://www.510kdatabase.net/og-image/k252757-cequr-simplicity-on-demand-insulin-fda-510k.jpg K252757 - CeQur Simplicity™ On-Demand Insulin Delivery System K252757 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Cequr SA. Cleared Apr 2026. https://www.510kdatabase.net/k252942/ 2026-04-10 monthly 0.8 https://www.510kdatabase.net/og-image/k252942-shaeferh-fda-510k.jpg K252942 - ShaeferH K252942 is a FDA 510(k) cleared dental medical device. Manufacturer: Shaeferh, LLC. Cleared Apr 2026. https://www.510kdatabase.net/k253361/ 2026-04-10 monthly 0.8 https://www.510kdatabase.net/og-image/k253361-teleport-glide-microcatheter-fda-510k.jpg K253361 - Teleport Glide Microcatheter K253361 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: OrbusNeich Medical (Shenzhen) Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k253446/ 2026-04-10 monthly 0.8 https://www.510kdatabase.net/og-image/k253446-aerodr-tx-c02-fda-510k.jpg K253446 - AeroDR TX c02 K253446 is a FDA 510(k) cleared radiology medical device. Manufacturer: Dk Medical Systems Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k253510/ 2026-04-10 monthly 0.8 https://www.510kdatabase.net/og-image/k253510-freestyle-mini-hands-free-fda-510k.jpg K253510 - Freestyle Mini Hands-free K253510 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Medela, LLC. Cleared Apr 2026. https://www.510kdatabase.net/k253657/ 2026-04-10 monthly 0.8 https://www.510kdatabase.net/og-image/k253657-tri-staple-20-reloads-fda-510k.jpg K253657 - Tri-staple 2.0™ Reloads K253657 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien (Part of Medtronic). Cleared Apr 2026. https://www.510kdatabase.net/k253689/ 2026-04-10 monthly 0.8 https://www.510kdatabase.net/og-image/k253689-syngo-dynamics-va41f-fda-510k.jpg K253689 - syngo Dynamics (VA41F) K253689 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Healthcare GmbH. Cleared Apr 2026. https://www.510kdatabase.net/k253777/ 2026-04-10 monthly 0.8 https://www.510kdatabase.net/og-image/k253777-ascblue-8010-fda-510k.jpg K253777 - Ascblue (8010) K253777 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ascblue Corporation. Cleared Apr 2026. https://www.510kdatabase.net/k253917/ 2026-04-10 monthly 0.8 https://www.510kdatabase.net/og-image/k253917-arion-arc-system-fda-510k.jpg K253917 - ARION ARC System K253917 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Plasma Surgical, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k253926/ 2026-04-10 monthly 0.8 https://www.510kdatabase.net/og-image/k253926-diacore-fda-510k.jpg K253926 - Diacore K253926 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: ShenB Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k253930/ 2026-04-10 monthly 0.8 https://www.510kdatabase.net/og-image/k253930-overjet-iris-intelligent-imaging-system-fda-510k.jpg K253930 - Overjet Iris Intelligent Imaging System K253930 is a FDA 510(k) cleared radiology medical device. Manufacturer: Overjet, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k254004/ 2026-04-10 monthly 0.8 https://www.510kdatabase.net/og-image/k254004-vrnt-fda-510k.jpg K254004 - VRNT K254004 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Cognifisense, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k260082/ 2026-04-10 monthly 0.8 https://www.510kdatabase.net/og-image/k260082-trios-dx-r1-fda-510k.jpg K260082 - TRIOS Dx (R1) K260082 is a FDA 510(k) cleared dental medical device. Manufacturer: 3Shape TRIOS A/S. Cleared Apr 2026. https://www.510kdatabase.net/k260090/ 2026-04-10 monthly 0.8 https://www.510kdatabase.net/og-image/k260090-smart-osteotomy-system-fda-510k.jpg K260090 - SMART Osteotomy System K260090 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Actis Medical Pty., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k260244/ 2026-04-10 monthly 0.8 https://www.510kdatabase.net/og-image/k260244-auryon-atherectomy-system-fda-510k.jpg K260244 - Auryon Atherectomy System K260244 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Eximo Medical. Cleared Apr 2026. https://www.510kdatabase.net/k260430/ 2026-04-10 monthly 0.8 https://www.510kdatabase.net/og-image/k260430-porcelain-etch-gel-fda-510k.jpg K260430 - Porcelain Etch Gel K260430 is a FDA 510(k) cleared dental medical device. Manufacturer: Belport Company, Inc., Gingi-Pak. Cleared Apr 2026. https://www.510kdatabase.net/k260508/ 2026-04-10 monthly 0.8 https://www.510kdatabase.net/og-image/k260508-lobo-vascular-occlusion-system-fda-510k.jpg K260508 - LOBO Vascular Occlusion System K260508 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Okami Medical, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k260839/ 2026-04-10 monthly 0.8 https://www.510kdatabase.net/og-image/k260839-protaryx-transseptal-puncture-device-fda-510k.jpg K260839 - Protaryx Transseptal Puncture Device (PTX2-001) K260839 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Protaryx Medical, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k252228/ 2026-04-09 monthly 0.8 https://www.510kdatabase.net/og-image/k252228-seaman-proseaman-fda-510k.jpg K252228 - Seaman Pro/Seaman K252228 is a FDA 510(k) cleared hematology medical device. Manufacturer: Checkcells, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k252251/ 2026-04-09 monthly 0.8 https://www.510kdatabase.net/og-image/k252251-easymade-ti-fda-510k.jpg K252251 - EASYMADE-TI K252251 is a FDA 510(k) cleared neurology medical device. Manufacturer: CG Bio Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k252929/ 2026-04-09 monthly 0.8 https://www.510kdatabase.net/og-image/k252929-single-use-digital-flexible-fda-510k.jpg K252929 - Single Use Digital Flexible Ureteroscope (7.5F) K252929 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Anhui Happiness Workshop Instruments Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k253975/ 2026-04-09 monthly 0.8 https://www.510kdatabase.net/og-image/k253975-radical-6f-access-catheter-fda-510k.jpg K253975 - Radical 6F Access Catheter K253975 is a FDA 510(k) cleared neurology medical device. Manufacturer: Maduro Medical, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k254021/ 2026-04-09 monthly 0.8 https://www.510kdatabase.net/og-image/k254021-accuro-xv-fda-510k.jpg K254021 - Accuro XV K254021 is a FDA 510(k) cleared radiology medical device. Manufacturer: Rivanna Medical, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k254158/ 2026-04-09 monthly 0.8 https://www.510kdatabase.net/og-image/k254158-spineart-navigation-instrument-system-fda-510k.jpg K254158 - SPINEART Navigation Instrument System K254158 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spineart SA. Cleared Apr 2026. https://www.510kdatabase.net/k260017/ 2026-04-09 monthly 0.8 https://www.510kdatabase.net/og-image/k260017-picosecond-ndyag-laser-systems-model-fda-510k.jpg K260017 - Picosecond Nd:YAG Laser Systems (Model: HS-298) K260017 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shanghai Apolo Medical Technology Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k260067/ 2026-04-09 monthly 0.8 https://www.510kdatabase.net/og-image/k260067-eternal-art-porcelain-powders-fda-510k.jpg K260067 - Eternal Art Porcelain Powders K260067 is a FDA 510(k) cleared dental medical device. Manufacturer: Shandong Huge Dental Material Corporation. Cleared Apr 2026. https://www.510kdatabase.net/k260245/ 2026-04-09 monthly 0.8 https://www.510kdatabase.net/og-image/k260245-silkbridge-fda-510k.jpg K260245 - SILKBridge K260245 is a FDA 510(k) cleared neurology medical device. Manufacturer: KLISBio S.r.l.. Cleared Apr 2026. https://www.510kdatabase.net/k260317/ 2026-04-09 monthly 0.8 https://www.510kdatabase.net/og-image/k260317-artelon-convenience-kits-fda-510k.jpg K260317 - Artelon Convenience Kits K260317 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: International Life Sciences. Cleared Apr 2026. https://www.510kdatabase.net/k260462/ 2026-04-09 monthly 0.8 https://www.510kdatabase.net/og-image/k260462-rct800-fda-510k.jpg K260462 - RCT800 K260462 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ray Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k260555/ 2026-04-09 monthly 0.8 https://www.510kdatabase.net/og-image/k260555-locator-angled-abutment-fda-510k.jpg K260555 - LOCATOR® Angled Abutment K260555 is a FDA 510(k) cleared dental medical device. Manufacturer: Zest Anchors, LLC. Cleared Apr 2026. https://www.510kdatabase.net/k251666/ 2026-04-08 monthly 0.8 https://www.510kdatabase.net/og-image/k251666-system-1e-liquid-chemical-sterilant-fda-510k.jpg K251666 - SYSTEM 1E Liquid Chemical Sterilant Processing System, Model P6700 K251666 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Apr 2026. https://www.510kdatabase.net/k251889/ 2026-04-08 monthly 0.8 https://www.510kdatabase.net/og-image/k251889-myair-fda-510k.jpg K251889 - myAir K251889 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: ResMed Corp. Cleared Apr 2026. https://www.510kdatabase.net/k252224/ 2026-04-08 monthly 0.8 https://www.510kdatabase.net/og-image/k252224-apex-locator-findpex-fda-510k.jpg K252224 - Apex Locator (FindPex) K252224 is a FDA 510(k) cleared dental medical device. Manufacturer: Changzhou Sifary Medical Technology Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k252270/ 2026-04-08 monthly 0.8 https://www.510kdatabase.net/og-image/k252270-hemoclip-fda-510k.jpg K252270 - Hemoclip K252270 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hangzhou AGS MedTech Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k253268/ 2026-04-08 monthly 0.8 https://www.510kdatabase.net/og-image/k253268-profoject-enteraloral-feeding-syringe-fda-510k.jpg K253268 - Profoject Enteral/Oral Feeding Syringe K253268 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: CMT Health PTE., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k253534/ 2026-04-08 monthly 0.8 https://www.510kdatabase.net/og-image/k253534-pivot-insulin-delivery-system-fda-510k.jpg K253534 - Pivot Insulin Delivery System K253534 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Modular Medical. Cleared Apr 2026. https://www.510kdatabase.net/k254258/ 2026-04-08 monthly 0.8 https://www.510kdatabase.net/og-image/k254258-momcozy-wearable-breast-pump-bp137-fda-510k.jpg K254258 - Momcozy Wearable Breast Pump (BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B, BP141, BP141-A, BP141-B, BP141-C, BP141-D) K254258 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shenzhen Root Innovation Technology Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k260033/ 2026-04-08 monthly 0.8 https://www.510kdatabase.net/og-image/k260033-wearable-breast-pump-model-s21a-fda-510k.jpg K260033 - Wearable Breast Pump (Model S21A) K260033 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shenzhen TPH Technology Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k260089/ 2026-04-08 monthly 0.8 https://www.510kdatabase.net/og-image/k260089-tl-10-laparoscopic-scope-cleaner-fda-510k.jpg K260089 - TL-10 Laparoscopic Scope Cleaner K260089 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Scopix , Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k260197/ 2026-04-08 monthly 0.8 https://www.510kdatabase.net/og-image/k260197-shogun-axis-fascial-closure-system-fda-510k.jpg K260197 - Shogun Axis™ Fascial Closure System (1018S, 1018B, 1218S, 1218B, 1518S, 1518B) K260197 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Suzhou Shenyun Medical Equipment Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k260420/ 2026-04-08 monthly 0.8 https://www.510kdatabase.net/og-image/k260420-loopview-single-use-digital-flexible-fda-510k.jpg K260420 - LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG) K260420 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: MacroLux Medical Technology Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k260477/ 2026-04-08 monthly 0.8 https://www.510kdatabase.net/og-image/k260477-catamaran-si-joint-fusion-system-fda-510k.jpg K260477 - CATAMARAN™ SI Joint Fusion System K260477 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tenon Medical. Cleared Apr 2026. https://www.510kdatabase.net/k260766/ 2026-04-08 monthly 0.8 https://www.510kdatabase.net/og-image/k260766-celerity-5-hp-biological-indicator-fda-510k.jpg K260766 - Celerity 5 HP Biological Indicator (LCB052) K260766 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Apr 2026. https://www.510kdatabase.net/k260816/ 2026-04-08 monthly 0.8 https://www.510kdatabase.net/og-image/k260816-opticross-coronary-imaging-catheter-fda-510k.jpg K260816 - OptiCross Coronary Imaging Catheter (H749518110) K260816 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific. Cleared Apr 2026. https://www.510kdatabase.net/k252116/ 2026-04-07 monthly 0.8 https://www.510kdatabase.net/og-image/k252116-firefighter-pro-ptca-balloon-catheter-fda-510k.jpg K252116 - Firefighter™ Pro PTCA Balloon Catheter K252116 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shanghai MicroPort Medical (Group) Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k252861/ 2026-04-07 monthly 0.8 https://www.510kdatabase.net/og-image/k252861-warming-system-fda-510k.jpg K252861 - Warming System K252861 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hangzhou Tappa Medical Technology Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k252979/ 2026-04-07 monthly 0.8 https://www.510kdatabase.net/og-image/k252979-voyager-dslt-430840610-fda-510k.jpg K252979 - Voyager DSLT (430840610) K252979 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Belkin Vision, Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k253801/ 2026-04-07 monthly 0.8 https://www.510kdatabase.net/og-image/k253801-ecg-ai-cardiac-amyloidosis-ca-12-lead-fda-510k.jpg K253801 - ECG-AI Cardiac Amyloidosis (CA) 12-Lead Algorithm (1040) K253801 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Anumana, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k253905/ 2026-04-07 monthly 0.8 https://www.510kdatabase.net/og-image/k253905-primesight-ultraview-system-fda-510k.jpg K253905 - PrimeSight UltraView System K253905 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cogentix Medical, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k253946/ 2026-04-07 monthly 0.8 https://www.510kdatabase.net/og-image/k253946-momcozy-wearable-breast-pump-s9-pro-s9-fda-510k.jpg K253946 - Momcozy Wearable Breast Pump (S9 Pro, S9 Pro-A, S9 Pro-B, S9 Pro-C, S9 Pro-D, S9 ProY-A, S9 ProY-B, S9 ProY-C, S12 Pro, S12 Pro-A, S12 Pro-B, S12 Pro-C, S12 Pro-D, S12 ProY-A, S12 ProY-B, S12 ProY-C) K253946 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shenzhen Root Innovation Technology Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k253952/ 2026-04-07 monthly 0.8 https://www.510kdatabase.net/og-image/k253952-power-wheelchair-os-r-m01s-fda-510k.jpg K253952 - Power Wheelchair (OS-R-M01S) K253952 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Beijing OrionStar Technology Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k254191/ 2026-04-07 monthly 0.8 https://www.510kdatabase.net/og-image/k254191-iwd-gel-fda-510k.jpg K254191 - IWD-Gel™ K254191 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: InnovaCorium, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k260046/ 2026-04-07 monthly 0.8 https://www.510kdatabase.net/og-image/k260046-elecsys-anti-hbc-ii-fda-510k.jpg K260046 - Elecsys Anti-HBc II K260046 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Diagnostics. Cleared Apr 2026. https://www.510kdatabase.net/k260048/ 2026-04-07 monthly 0.8 https://www.510kdatabase.net/og-image/k260048-elecsys-anti-hav-igm-fda-510k.jpg K260048 - Elecsys Anti-HAV IgM K260048 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Diagnostics. Cleared Apr 2026. https://www.510kdatabase.net/k260049/ 2026-04-07 monthly 0.8 https://www.510kdatabase.net/og-image/k260049-elecsys-anti-hbc-igm-fda-510k.jpg K260049 - Elecsys Anti-HBc IgM K260049 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Diagnostics. Cleared Apr 2026. https://www.510kdatabase.net/k260466/ 2026-04-07 monthly 0.8 https://www.510kdatabase.net/og-image/k260466-multifunctional-operational-dissectors-fda-510k.jpg K260466 - Multifunctional Operational Dissectors (Electrosurgical Pencils) K260466 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Zhejiang shuyou Surgical Instrument Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k260860/ 2026-04-07 monthly 0.8 https://www.510kdatabase.net/og-image/k260860-powder-free-synthetic-vinyl-exam-fda-510k.jpg K260860 - Powder Free Synthetic Vinyl Exam Gloves (Blue, Black) K260860 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Basic Medical Technology, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k260942/ 2026-04-07 monthly 0.8 https://www.510kdatabase.net/og-image/k260942-aust-steerable-sheath-fda-510k.jpg K260942 - AuST Steerable Sheath K260942 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: CenterPoint Systems, LLC. Cleared Apr 2026. https://www.510kdatabase.net/k250208/ 2026-04-06 monthly 0.8 https://www.510kdatabase.net/og-image/k250208-spectra-wearable-2-fda-510k.jpg K250208 - SPECTRA Wearable 2 K250208 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Uzinmedicare Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k252182/ 2026-04-06 monthly 0.8 https://www.510kdatabase.net/og-image/k252182-sv70-ventilator-sv70-fda-510k.jpg K252182 - SV70 Ventilator (SV70) K252182 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k252765/ 2026-04-06 monthly 0.8 https://www.510kdatabase.net/og-image/k252765-prosomnus-rpmo2-osa-device-rpmo2-osa-fda-510k.jpg K252765 - ProSomnus RPMO2 OSA Device (RPMO2 OSA) K252765 is a FDA 510(k) cleared dental medical device. Manufacturer: Prosomnus Sleep Technologies. Cleared Apr 2026. https://www.510kdatabase.net/k252809/ 2026-04-06 monthly 0.8 https://www.510kdatabase.net/og-image/k252809-in2-smart-in2s-fda-510k.jpg K252809 - in2 Smart (in2S) K252809 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Virility Medical , Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k253025/ 2026-04-06 monthly 0.8 https://www.510kdatabase.net/og-image/k253025-ricoh-3d-for-healthcare-bolus-fda-510k.jpg K253025 - Ricoh 3D for Healthcare Bolus K253025 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ricoh 3D For Healthcare, LLC. Cleared Apr 2026. https://www.510kdatabase.net/k253036/ 2026-04-06 monthly 0.8 https://www.510kdatabase.net/og-image/k253036-light-curing-coloring-materials-alcm-fda-510k.jpg K253036 - Light-curing Coloring Materials (ALCM) K253036 is a FDA 510(k) cleared dental medical device. Manufacturer: Aidite (Qinhuangdao) Technology Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k253288/ 2026-04-06 monthly 0.8 https://www.510kdatabase.net/og-image/k253288-6450-ultrasound-system-mylabe80-fda-510k.jpg K253288 - 6450 Ultrasound System (MyLabE80) K253288 is a FDA 510(k) cleared radiology medical device. Manufacturer: Esaote, S.P.A.. Cleared Apr 2026. https://www.510kdatabase.net/k253862/ 2026-04-06 monthly 0.8 https://www.510kdatabase.net/og-image/k253862-aperto-lucent-mri-system-fda-510k.jpg K253862 - APERTO Lucent MRI System K253862 is a FDA 510(k) cleared radiology medical device. Manufacturer: Fujifilm Corporation. Cleared Apr 2026. https://www.510kdatabase.net/k254084/ 2026-04-06 monthly 0.8 https://www.510kdatabase.net/og-image/k254084-aetos-shoulder-system-conceloc-glenoids-fda-510k.jpg K254084 - AETOS Shoulder System - CONCELOC Glenoids K254084 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k254091/ 2026-04-06 monthly 0.8 https://www.510kdatabase.net/og-image/k254091-glossy-coat-15ml-fda-510k.jpg K254091 - GLOSSY COAT (15ML) K254091 is a FDA 510(k) cleared dental medical device. Manufacturer: YAMAHACHI DENTAL MFG., Co.. Cleared Apr 2026. https://www.510kdatabase.net/k260397/ 2026-04-06 monthly 0.8 https://www.510kdatabase.net/og-image/k260397-synerjet-pro-sp-1002-fda-510k.jpg K260397 - SYNERJET PRO (SP-1002) K260397 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Hironic Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k260459/ 2026-04-06 monthly 0.8 https://www.510kdatabase.net/og-image/k260459-vanes-delivery-system-vds-fda-510k.jpg K260459 - VANES Delivery System (VDS) K260459 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Zoll Respicardia, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k260521/ 2026-04-06 monthly 0.8 https://www.510kdatabase.net/og-image/k260521-clearevac-ureteral-aspirating-access-fda-510k.jpg K260521 - ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250) K260521 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Zhuhai Pusen Medical Technology Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k252386/ 2026-04-03 monthly 0.8 https://www.510kdatabase.net/og-image/k252386-hot-and-cold-compression-system-a02-c-fda-510k.jpg K252386 - Hot and Cold Compression System (A02-C-032) K252386 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Chengdu Cryo-Push Medical Technology Co.,Ltd. Cleared Apr 2026. https://www.510kdatabase.net/k252495/ 2026-04-03 monthly 0.8 https://www.510kdatabase.net/og-image/k252495-lssa-np-200-fda-510k.jpg K252495 - LSSA (NP-200) K252495 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Newpong Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k252744/ 2026-04-03 monthly 0.8 https://www.510kdatabase.net/og-image/k252744-wearable-electric-breast-pump-rh-668-fda-510k.jpg K252744 - Wearable Electric Breast Pump (RH 668, RH 708, RH 718, RH 728) K252744 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Cixi Ruihong Electric Appliance Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k253042/ 2026-04-03 monthly 0.8 https://www.510kdatabase.net/og-image/k253042-tyber-medical-trauma-screw-fda-510k.jpg K253042 - Tyber Medical Trauma Screw K253042 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tyber Medical, LLC. Cleared Apr 2026. https://www.510kdatabase.net/k253056/ 2026-04-03 monthly 0.8 https://www.510kdatabase.net/og-image/k253056-disposable-stone-extraction-basket-fda-510k.jpg K253056 - Disposable Stone Extraction Basket K253056 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Zhejiang Soudon Medical Technology Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k253340/ 2026-04-03 monthly 0.8 https://www.510kdatabase.net/og-image/k253340-electric-wheelchair-al-208s-063-fda-510k.jpg K253340 - Electric Wheelchair (AL-208S-063) K253340 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zhongshan A&J Medical Equipment Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k253674/ 2026-04-03 monthly 0.8 https://www.510kdatabase.net/og-image/k253674-blueprint-patient-specific-fda-510k.jpg K253674 - Blueprint Patient-Specific Instrumentation K253674 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Corporation (Tornier, S.A.S.). Cleared Apr 2026. https://www.510kdatabase.net/k253962/ 2026-04-03 monthly 0.8 https://www.510kdatabase.net/og-image/k253962-clearcheck-radcc-v27-fda-510k.jpg K253962 - ClearCheck (RADCC V2.7) K253962 is a FDA 510(k) cleared radiology medical device. Manufacturer: Radformation, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k254060/ 2026-04-03 monthly 0.8 https://www.510kdatabase.net/og-image/k254060-life-saving-tourniquet-fda-510k.jpg K254060 - Life Saving Tourniquet K254060 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: TW Medical. Cleared Apr 2026. https://www.510kdatabase.net/k254066/ 2026-04-03 monthly 0.8 https://www.510kdatabase.net/og-image/k254066-etiometry-platform-fda-510k.jpg K254066 - Etiometry Platform K254066 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Etiometry, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k254153/ 2026-04-03 monthly 0.8 https://www.510kdatabase.net/og-image/k254153-single-use-video-scope-fda-510k.jpg K254153 - Single-use Video Scope K254153 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Mirco-Tech (Nanjing) Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k260363/ 2026-04-03 monthly 0.8 https://www.510kdatabase.net/og-image/k260363-ceribell-brain-monitor-headband-fda-510k.jpg K260363 - Ceribell Brain Monitor Headband K260363 is a FDA 510(k) cleared neurology medical device. Manufacturer: Ceribell, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k260524/ 2026-04-03 monthly 0.8 https://www.510kdatabase.net/og-image/k260524-umi-panvivo-umi-panvivo-ls-fda-510k.jpg K260524 - uMI Panvivo (uMI Panvivo LS) K260524 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k260718/ 2026-04-03 monthly 0.8 https://www.510kdatabase.net/og-image/k260718-mgrip-partial-prosthesis-075-mm-58669-fda-510k.jpg K260718 - mGRIP Partial Prosthesis (0.75 mm) (58669) K260718 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Med-El Elektromedizinische Ger?te GmbH. Cleared Apr 2026. https://www.510kdatabase.net/k260719/ 2026-04-03 monthly 0.8 https://www.510kdatabase.net/og-image/k260719-mgrip-total-prosthesis-300-mm-58689-fda-510k.jpg K260719 - mGRIP Total Prosthesis (3.00 mm) (58689) K260719 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Med-El Elektromedizinische Ger?te GmbH. Cleared Apr 2026. https://www.510kdatabase.net/k260720/ 2026-04-03 monthly 0.8 https://www.510kdatabase.net/og-image/k260720-mwing-stapes-prosthesis-04-x-350-mm-fda-510k.jpg K260720 - mWING Stapes Prosthesis (0.4 x 3.50 mm) (58717) K260720 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Med-El Elektromedizinische Ger?te GmbH. Cleared Apr 2026. https://www.510kdatabase.net/k260724/ 2026-04-03 monthly 0.8 https://www.510kdatabase.net/og-image/k260724-magentiq-colo-me-apds-fda-510k.jpg K260724 - MAGENTIQ-COLO (ME-APDS) K260724 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Magentiq Eye, Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k260786/ 2026-04-03 monthly 0.8 https://www.510kdatabase.net/og-image/k260786-kheiron-spinal-fixation-system-fda-510k.jpg K260786 - KHEIRON® Spinal Fixation System, including patient specific K-ROD K260786 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: S.M.A.I.O. Cleared Apr 2026. https://www.510kdatabase.net/den240071/ 2026-04-03 monthly 0.8 https://www.510kdatabase.net/og-image/den240071-neuropacs-fda-510k.jpg DEN240071 - neuropacs DEN240071 is a FDA 510(k) cleared neurology medical device. Manufacturer: Automated Imaging Diagnostics, LLC. Cleared Apr 2026. https://www.510kdatabase.net/k250516/ 2026-04-02 monthly 0.8 https://www.510kdatabase.net/og-image/k250516-smart-m-cell-prp-concentration-system-fda-510k.jpg K250516 - SMART M-CELL PRP Concentration System K250516 is a FDA 510(k) cleared hematology medical device. Manufacturer: Miracell Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k250518/ 2026-04-02 monthly 0.8 https://www.510kdatabase.net/og-image/k250518-smart-m-cell-bone-marrow-concentration-fda-510k.jpg K250518 - SMART M-CELL Bone Marrow Concentration System K250518 is a FDA 510(k) cleared hematology medical device. Manufacturer: Miracell Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k252079/ 2026-04-02 monthly 0.8 https://www.510kdatabase.net/og-image/k252079-disposable-infusion-bag-for-parenteral-fda-510k.jpg K252079 - Disposable Infusion Bag for Parenteral Nutrition K252079 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Beijing L&Z Medical Technology Development Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k252130/ 2026-04-02 monthly 0.8 https://www.510kdatabase.net/og-image/k252130-lifeshield-infusion-safety-software-fda-510k.jpg K252130 - LifeShield Infusion Safety Software Suite K252130 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Icu Medical, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k252137/ 2026-04-02 monthly 0.8 https://www.510kdatabase.net/og-image/k252137-bd-insyte-iv-catheter-fda-510k.jpg K252137 - BD Insyte™ IV Catheter K252137 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton Dickinson Infusion Therapy Systems, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k252198/ 2026-04-02 monthly 0.8 https://www.510kdatabase.net/og-image/k252198-advanced-cryo-skin-tag-remover-fda-510k.jpg K252198 - Advanced Cryo Skin Tag Remover (Advanced Skin Tag Remover) K252198 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medical Brands Laboratories B.V.. Cleared Apr 2026. https://www.510kdatabase.net/k252229/ 2026-04-02 monthly 0.8 https://www.510kdatabase.net/og-image/k252229-belliger-ace-fda-510k.jpg K252229 - BELLIGER ACE K252229 is a FDA 510(k) cleared radiology medical device. Manufacturer: Genoray Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k252246/ 2026-04-02 monthly 0.8 https://www.510kdatabase.net/og-image/k252246-leforte-mmf-system-fda-510k.jpg K252246 - Leforte MMF System K252246 is a FDA 510(k) cleared dental medical device. Manufacturer: Jeil Medical Corporation. Cleared Apr 2026. https://www.510kdatabase.net/k252709/ 2026-04-02 monthly 0.8 https://www.510kdatabase.net/og-image/k252709-wireless-probe-type-ultrasound-scanner-fda-510k.jpg K252709 - Wireless Probe Type Ultrasound Scanner K252709 is a FDA 510(k) cleared radiology medical device. Manufacturer: Xuzhou Yongkang Electronic Science Technology Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k253076/ 2026-04-02 monthly 0.8 https://www.510kdatabase.net/og-image/k253076-cryopush-cold-compression-device-a02-p-fda-510k.jpg K253076 - Cryopush Cold Compression Device (A02-P-001) K253076 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Chengdu Cryo-Push Medical Technology Co.,Ltd. Cleared Apr 2026. https://www.510kdatabase.net/k254022/ 2026-04-02 monthly 0.8 https://www.510kdatabase.net/og-image/k254022-flash-flex-aorto-ostial-angioplasty-fda-510k.jpg K254022 - FLASH Flex™ Aorto-Ostial Angioplasty System K254022 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Verge Medical, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k260026/ 2026-04-02 monthly 0.8 https://www.510kdatabase.net/og-image/k260026-tina-quant-cardiac-high-sensitivity-fda-510k.jpg K260026 - Tina-quant Cardiac high sensitivity CRP III K260026 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Apr 2026. https://www.510kdatabase.net/k260184/ 2026-04-02 monthly 0.8 https://www.510kdatabase.net/og-image/k260184-onclarity-self-collection-kit-fda-510k.jpg K260184 - Onclarity™ Self-Collection Kit K260184 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson and Company. Cleared Apr 2026. https://www.510kdatabase.net/k260647/ 2026-04-02 monthly 0.8 https://www.510kdatabase.net/og-image/k260647-specchio-fda-510k.jpg K260647 - SPECCHIO K260647 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: El.En S.P.A.. Cleared Apr 2026. https://www.510kdatabase.net/k260796/ 2026-04-02 monthly 0.8 https://www.510kdatabase.net/og-image/k260796-tahoe-unicondylar-knee-system-with-fda-510k.jpg K260796 - Tahoe Unicondylar Knee System with TiNbN Overcoat K260796 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics. Cleared Apr 2026. https://www.510kdatabase.net/k242303/ 2026-04-01 monthly 0.8 https://www.510kdatabase.net/og-image/k242303-mod-c-fda-510k.jpg K242303 - MOD-C K242303 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthomod, LLC. Cleared Apr 2026. https://www.510kdatabase.net/k252513/ 2026-04-01 monthly 0.8 https://www.510kdatabase.net/og-image/k252513-polywin-safety-14g-x-51mm-fda-510k.jpg K252513 - Polywin Safety (14G x 51mm K252513 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Poly Medicure Limited. Cleared Apr 2026. https://www.510kdatabase.net/k252876/ 2026-04-01 monthly 0.8 https://www.510kdatabase.net/og-image/k252876-gem-flex-coil-16-l-array-30t-receive-fda-510k.jpg K252876 - GEM Flex Coil 16-L Array, 3.0T Receive Only K252876 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen RF Tech Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k252943/ 2026-04-01 monthly 0.8 https://www.510kdatabase.net/og-image/k252943-gentlecath-air-for-men-fda-510k.jpg K252943 - GentleCath Air for Men K252943 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Convatec Limited. Cleared Apr 2026. https://www.510kdatabase.net/k253405/ 2026-04-01 monthly 0.8 https://www.510kdatabase.net/og-image/k253405-prana-system-fda-510k.jpg K253405 - Prana System K253405 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Prana Surgical. Cleared Apr 2026. https://www.510kdatabase.net/k253473/ 2026-04-01 monthly 0.8 https://www.510kdatabase.net/og-image/k253473-synchrony-fda-510k.jpg K253473 - Synchrony K253473 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Stereotaxis, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k253582/ 2026-04-01 monthly 0.8 https://www.510kdatabase.net/og-image/k253582-medical-imaging-calibration-feature-micf-fda-510k.jpg K253582 - Medical Imaging Calibration Feature (MICF) K253582 is a FDA 510(k) cleared radiology medical device. Manufacturer: Apple, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k253586/ 2026-04-01 monthly 0.8 https://www.510kdatabase.net/og-image/k253586-rm-electrode-rmh-25-01-fda-510k.jpg K253586 - RM Electrode (RMH 25-01) K253586 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Retmap, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k253718/ 2026-04-01 monthly 0.8 https://www.510kdatabase.net/og-image/k253718-enhance-peek-bunion-system-fda-510k.jpg K253718 - enHAnce PEEK Bunion System K253718 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nvision Biomedical Technologies, Inc.. Cleared Apr 2026. https://www.510kdatabase.net/k254015/ 2026-04-01 monthly 0.8 https://www.510kdatabase.net/og-image/k254015-columbo-c-spine-fda-510k.jpg K254015 - CoLumbo C-Spine K254015 is a FDA 510(k) cleared radiology medical device. Manufacturer: Smart Soft Healthcare AD. Cleared Apr 2026. https://www.510kdatabase.net/k254225/ 2026-04-01 monthly 0.8 https://www.510kdatabase.net/og-image/k254225-arm-blood-pressure-monitor-hh-802cb-hh-fda-510k.jpg K254225 - Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH-808EL) K254225 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen HanHan Technology Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k260007/ 2026-04-01 monthly 0.8 https://www.510kdatabase.net/og-image/k260007-hyaluronic-acid-vaginal-suppository-ha-fda-510k.jpg K260007 - Hyaluronic Acid Vaginal Suppository (HA 5 mg) K260007 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Hudi Pharma Srl. Cleared Apr 2026. https://www.510kdatabase.net/k260276/ 2026-04-01 monthly 0.8 https://www.510kdatabase.net/og-image/k260276-arm-blood-pressure-monitor-models-arm-fda-510k.jpg K260276 - Arm Blood Pressure Monitor Models: ARM-30C+ K260276 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen AOJ Medical Technology Co., Ltd.. Cleared Apr 2026. https://www.510kdatabase.net/k252360/ 2026-03-28 monthly 0.8 https://www.510kdatabase.net/og-image/k252360-ecg-ai-pulmonary-hypertension-ph-12-fda-510k.jpg K252360 - ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) K252360 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Anumana, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k260257/ 2026-03-28 monthly 0.8 https://www.510kdatabase.net/og-image/k260257-co2-laser-system-fda-510k.jpg K260257 - CO2 Laser System K260257 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sanhe Meditech Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k251273/ 2026-03-27 monthly 0.8 https://www.510kdatabase.net/og-image/k251273-asurys-fluid-management-system-fda-510k.jpg K251273 - Asurys Fluid Management System K251273 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Boston Scientific Corporation. Cleared Mar 2026. https://www.510kdatabase.net/k252006/ 2026-03-27 monthly 0.8 https://www.510kdatabase.net/og-image/k252006-otto-disinfecting-cap-fda-510k.jpg K252006 - OTTO™ Disinfecting Cap K252006 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Icu Medical, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k252064/ 2026-03-27 monthly 0.8 https://www.510kdatabase.net/og-image/k252064-medcad-accustride-system-fda-510k.jpg K252064 - MedCAD® AccuStride™ System K252064 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medcad. Cleared Mar 2026. https://www.510kdatabase.net/k252081/ 2026-03-27 monthly 0.8 https://www.510kdatabase.net/og-image/k252081-sportlinc-syndesmosis-device-fda-510k.jpg K252081 - SportLinc Syndesmosis Device K252081 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Lincotek Medical. Cleared Mar 2026. https://www.510kdatabase.net/k252148/ 2026-03-27 monthly 0.8 https://www.510kdatabase.net/og-image/k252148-butterfly-gestational-age-tool-fda-510k.jpg K252148 - Butterfly Gestational Age Tool K252148 is a FDA 510(k) cleared radiology medical device. Manufacturer: Butterfly Network, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k252195/ 2026-03-27 monthly 0.8 https://www.510kdatabase.net/og-image/k252195-articor-planner-fda-510k.jpg K252195 - ARTICOR planner K252195 is a FDA 510(k) cleared radiology medical device. Manufacturer: Artiness S.R.L. Cleared Mar 2026. https://www.510kdatabase.net/k252295/ 2026-03-27 monthly 0.8 https://www.510kdatabase.net/og-image/k252295-ryurei-fda-510k.jpg K252295 - Ryurei K252295 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Corporation. Cleared Mar 2026. https://www.510kdatabase.net/k252893/ 2026-03-27 monthly 0.8 https://www.510kdatabase.net/og-image/k252893-exastim-stimulation-system-exa-001-fda-510k.jpg K252893 - ExaStim® Stimulation System (EXA-001) K252893 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Aneuvo. Cleared Mar 2026. https://www.510kdatabase.net/k253270/ 2026-03-27 monthly 0.8 https://www.510kdatabase.net/og-image/k253270-contour-protgai-fda-510k.jpg K253270 - Contour ProtégéAI+ K253270 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mim Software, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k253307/ 2026-03-27 monthly 0.8 https://www.510kdatabase.net/og-image/k253307-electric-wheelchair-fda-510k.jpg K253307 - Electric wheelchair K253307 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Foshan Dahao Medical Technology Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k253392/ 2026-03-27 monthly 0.8 https://www.510kdatabase.net/og-image/k253392-synergy-disc-instruments-fda-510k.jpg K253392 - Synergy Disc Instruments K253392 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synergy Spine Solutions, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k253572/ 2026-03-27 monthly 0.8 https://www.510kdatabase.net/og-image/k253572-stratafix-spiral-pronova-fda-510k.jpg K253572 - STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATAFIX™ Spiral PRONOVA™ Bidirectional Knotless Tissue Control Device K253572 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k253595/ 2026-03-27 monthly 0.8 https://www.510kdatabase.net/og-image/k253595-epiq-series-diagnostic-ultrasound-fda-510k.jpg K253595 - EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System K253595 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Ultrasound, LLC. Cleared Mar 2026. https://www.510kdatabase.net/k253625/ 2026-03-27 monthly 0.8 https://www.510kdatabase.net/og-image/k253625-vantage-fortianorian-15t-mrt-1550-v100-fda-510k.jpg K253625 - Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR K253625 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Mar 2026. https://www.510kdatabase.net/k253649/ 2026-03-27 monthly 0.8 https://www.510kdatabase.net/og-image/k253649-spectral-ct-verida-family-fda-510k.jpg K253649 - Spectral CT Verida Family K253649 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Technologies , Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k253822/ 2026-03-27 monthly 0.8 https://www.510kdatabase.net/og-image/k253822-gpa-hexafocon-a-rigid-gas-permeable-fda-510k.jpg K253822 - GPA (hexafocon A) Rigid Gas Permeable Contact Lenses K253822 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Zhuhai Fitlens Medical Technology Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k253980/ 2026-03-27 monthly 0.8 https://www.510kdatabase.net/og-image/k253980-electrically-powered-wheelchair-model-fda-510k.jpg K253980 - Electrically Powered Wheelchair (Model YC-01) K253980 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Yurob Rehabilitation Medical Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k254099/ 2026-03-27 monthly 0.8 https://www.510kdatabase.net/og-image/k254099-evo-q30-diagnostic-ultrasound-system-fda-510k.jpg K254099 - EVO Q30 Diagnostic Ultrasound System K254099 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Medison Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k254161/ 2026-03-27 monthly 0.8 https://www.510kdatabase.net/og-image/k254161-automated-aortic-stenosis-software-fda-510k.jpg K254161 - Automated Aortic Stenosis Software (AutoAS) K254161 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. Cleared Mar 2026. https://www.510kdatabase.net/k254206/ 2026-03-27 monthly 0.8 https://www.510kdatabase.net/og-image/k254206-power-wheelchair-zs-ew8026-fda-510k.jpg K254206 - Power wheelchair (ZS-EW8026) K254206 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Ningbo Zhishan Medical Technology Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k254239/ 2026-03-27 monthly 0.8 https://www.510kdatabase.net/og-image/k254239-cyclean-cord-fda-510k.jpg K254239 - CyClean Cord K254239 is a FDA 510(k) cleared dental medical device. Manufacturer: SS GLOBAL. Cleared Mar 2026. https://www.510kdatabase.net/k260041/ 2026-03-27 monthly 0.8 https://www.510kdatabase.net/og-image/k260041-mdx-chex-for-bcp-fda-510k.jpg K260041 - MDx-Chex for BCP K260041 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Streck, LLC. Cleared Mar 2026. https://www.510kdatabase.net/k260240/ 2026-03-27 monthly 0.8 https://www.510kdatabase.net/og-image/k260240-symphony-navigation-ready-instruments-fda-510k.jpg K260240 - SYMPHONY Navigation Ready Instruments K260240 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International SARL. Cleared Mar 2026. https://www.510kdatabase.net/k260255/ 2026-03-27 monthly 0.8 https://www.510kdatabase.net/og-image/k260255-aventix-pfx-system-pfx01-fda-510k.jpg K260255 - AVENTIX PFX System (PFX01) K260255 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Aventix Medical, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k260271/ 2026-03-27 monthly 0.8 https://www.510kdatabase.net/og-image/k260271-strauss-surgical-cystoscope-fda-510k.jpg K260271 - Strauss Surgical cystoscope, hysteroscope and accessories Instruments K260271 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: American Medical Endoscopy, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k260294/ 2026-03-27 monthly 0.8 https://www.510kdatabase.net/og-image/k260294-sf-push-in-anchor-fda-510k.jpg K260294 - SF Push-in Anchor K260294 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Surgical Fusion Technologies GmbH. Cleared Mar 2026. https://www.510kdatabase.net/k260697/ 2026-03-27 monthly 0.8 https://www.510kdatabase.net/og-image/k260697-vyplate-anterior-cervical-plate-system-fda-510k.jpg K260697 - VyPlate™ Anterior Cervical Plate System K260697 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Vy Spine, LLC. Cleared Mar 2026. https://www.510kdatabase.net/k260746/ 2026-03-27 monthly 0.8 https://www.510kdatabase.net/og-image/k260746-s-scan-open-100001800-fda-510k.jpg K260746 - S-scan Open (100001800) K260746 is a FDA 510(k) cleared radiology medical device. Manufacturer: Esaote, S.P.A.. Cleared Mar 2026. https://www.510kdatabase.net/k252926/ 2026-03-26 monthly 0.8 https://www.510kdatabase.net/og-image/k252926-robotic-surgical-instruments-permanent-fda-510k.jpg K252926 - Robotic Surgical Instruments - Permanent Cautery Hook (470183) K252926 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Restore Robotics. Cleared Mar 2026. https://www.510kdatabase.net/k253379/ 2026-03-26 monthly 0.8 https://www.510kdatabase.net/og-image/k253379-stealth-axis-cranial-clinical-fda-510k.jpg K253379 - Stealth AXiS Cranial clinical application K253379 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Navigation, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k253549/ 2026-03-26 monthly 0.8 https://www.510kdatabase.net/og-image/k253549-devilbiss-5-liter-oxygen-concentrator-fda-510k.jpg K253549 - DeVilbiss 5 Liter Oxygen Concentrator (555) K253549 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Devilbiss Healthcare, LLC. Cleared Mar 2026. https://www.510kdatabase.net/k253627/ 2026-03-26 monthly 0.8 https://www.510kdatabase.net/og-image/k253627-surgify-halo-54085shdu1-fda-510k.jpg K253627 - Surgify Halo (54.085.SHD.U1) K253627 is a FDA 510(k) cleared neurology medical device. Manufacturer: Surgify Medical OY. Cleared Mar 2026. https://www.510kdatabase.net/k253775/ 2026-03-26 monthly 0.8 https://www.510kdatabase.net/og-image/k253775-swiftmr-fda-510k.jpg K253775 - SwiftMR K253775 is a FDA 510(k) cleared radiology medical device. Manufacturer: Airs Medical, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k253796/ 2026-03-26 monthly 0.8 https://www.510kdatabase.net/og-image/k253796-lunit-insight-dbt-v12-fda-510k.jpg K253796 - Lunit INSIGHT DBT (V1.2) K253796 is a FDA 510(k) cleared radiology medical device. Manufacturer: Lunit, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k260273/ 2026-03-26 monthly 0.8 https://www.510kdatabase.net/og-image/k260273-automatic-electronic-blood-pressure-fda-510k.jpg K260273 - Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B,U90B Pro,U90B Plus,U90B Ultra,U90C,U90C Pro,U90C Plus,U90C Ultra).) K260273 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Urion Technology Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k260281/ 2026-03-26 monthly 0.8 https://www.510kdatabase.net/og-image/k260281-vitek-2-ast-streptococcus-cefuroxime-fda-510k.jpg K260281 - VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) K260281 is a FDA 510(k) cleared microbiology medical device. Manufacturer: BIOMERIEUX. Cleared Mar 2026. https://www.510kdatabase.net/k260601/ 2026-03-26 monthly 0.8 https://www.510kdatabase.net/og-image/k260601-real-intelligence-cori-fda-510k.jpg K260601 - REAL INTELLIGENCE™ CORI™ K260601 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Blue Belt Technologies, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k260626/ 2026-03-26 monthly 0.8 https://www.510kdatabase.net/og-image/k260626-multiflex-steerable-sheath-175f-fda-510k.jpg K260626 - Multiflex Steerable Sheath 17.5F K260626 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vizaramed, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k252023/ 2026-03-25 monthly 0.8 https://www.510kdatabase.net/og-image/k252023-mirachlor-antimicrobial-wound-solution-fda-510k.jpg K252023 - MiraChlor Antimicrobial Wound Solution K252023 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Letus Corporation. Cleared Mar 2026. https://www.510kdatabase.net/k252037/ 2026-03-25 monthly 0.8 https://www.510kdatabase.net/og-image/k252037-cuvis-joint-cj150-fda-510k.jpg K252037 - CUVIS-joint (CJ150) K252037 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Curexo, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k252052/ 2026-03-25 monthly 0.8 https://www.510kdatabase.net/og-image/k252052-stellaris-elite-vision-enhancement-fda-510k.jpg K252052 - Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) K252052 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Bausch and Lomb, Incorporated. Cleared Mar 2026. https://www.510kdatabase.net/k252432/ 2026-03-25 monthly 0.8 https://www.510kdatabase.net/og-image/k252432-flex-z-cervical-cage-fda-510k.jpg K252432 - Flex-Z™ Cervical Cage K252432 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinepoint, LLC. Cleared Mar 2026. https://www.510kdatabase.net/k252908/ 2026-03-25 monthly 0.8 https://www.510kdatabase.net/og-image/k252908-easydrip-classic-pen-needle-fda-510k.jpg K252908 - Easydrip Classic Pen Needle K252908 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sandstone Medical (Suzhou), Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k253184/ 2026-03-25 monthly 0.8 https://www.510kdatabase.net/og-image/k253184-video-rhinolaryngoscope-system-fda-510k.jpg K253184 - Video Rhinolaryngoscope System (Disposable Video Rhinolaryngoscope SP11A Endoscopic Video Processor M110B) K253184 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Zhuhai Wesee Meditech Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k253322/ 2026-03-25 monthly 0.8 https://www.510kdatabase.net/og-image/k253322-hudson-rci-infant-dri-techtm-breathing-fda-510k.jpg K253322 - Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78” Infant Circuit, HUD99060KIT / Dri-Tech with 78” Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60” Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44” Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel) K253322 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Medline Industries, LP. Cleared Mar 2026. https://www.510kdatabase.net/k253406/ 2026-03-25 monthly 0.8 https://www.510kdatabase.net/og-image/k253406-s250-fit-proton-beam-radiation-therapy-fda-510k.jpg K253406 - S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) K253406 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mevion Medical Systems, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k253615/ 2026-03-25 monthly 0.8 https://www.510kdatabase.net/og-image/k253615-invictus-bands-system-fda-510k.jpg K253615 - Invictus Bands System K253615 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k253680/ 2026-03-25 monthly 0.8 https://www.510kdatabase.net/og-image/k253680-lynx-coblation-laryngeal-wand-72290254-fda-510k.jpg K253680 - LYNX COBLATION Laryngeal Wand (72290254) K253680 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: ArthroCare Corporation. Cleared Mar 2026. https://www.510kdatabase.net/k254278/ 2026-03-25 monthly 0.8 https://www.510kdatabase.net/og-image/k254278-arterial-pressure-monitoring-settray-fda-510k.jpg K254278 - Arterial Pressure Monitoring Set/Tray K254278 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Spectrum Vascular. Cleared Mar 2026. https://www.510kdatabase.net/k260274/ 2026-03-25 monthly 0.8 https://www.510kdatabase.net/og-image/k260274-airlock-ankle-plating-system-fda-510k.jpg K260274 - Airlock® Ankle Plating System K260274 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Novastep SAS. Cleared Mar 2026. https://www.510kdatabase.net/k260291/ 2026-03-25 monthly 0.8 https://www.510kdatabase.net/og-image/k260291-vortex5-tailors-bunion-correction-system-fda-510k.jpg K260291 - Vortex5 Tailor's Bunion Correction System K260291 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nvision Biomedical Technologies, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k252099/ 2026-03-24 monthly 0.8 https://www.510kdatabase.net/og-image/k252099-trinias-fda-510k.jpg K252099 - Trinias K252099 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shimadzu Corporation. Cleared Mar 2026. https://www.510kdatabase.net/k252169/ 2026-03-24 monthly 0.8 https://www.510kdatabase.net/og-image/k252169-access-bnp-ii-fda-510k.jpg K252169 - Access BNP II K252169 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k252421/ 2026-03-24 monthly 0.8 https://www.510kdatabase.net/og-image/k252421-jlk-ncct-fda-510k.jpg K252421 - JLK-NCCT K252421 is a FDA 510(k) cleared radiology medical device. Manufacturer: JLK, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k253047/ 2026-03-24 monthly 0.8 https://www.510kdatabase.net/og-image/k253047-pressone-fda-510k.jpg K253047 - PRESSONE™ K253047 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Nipro Medical Corporation. Cleared Mar 2026. https://www.510kdatabase.net/k253198/ 2026-03-24 monthly 0.8 https://www.510kdatabase.net/og-image/k253198-nanoknife-generator-h78720300351us0-fda-510k.jpg K253198 - NanoKnife Generator (H78720300351US0) K253198 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Angiodynamics. Cleared Mar 2026. https://www.510kdatabase.net/k254012/ 2026-03-24 monthly 0.8 https://www.510kdatabase.net/og-image/k254012-electric-wheelchair-e201-fda-510k.jpg K254012 - Electric Wheelchair (E201) K254012 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Nanjing CareMoving Rehabilitation Equipment Co.,Ltd. Cleared Mar 2026. https://www.510kdatabase.net/k254253/ 2026-03-24 monthly 0.8 https://www.510kdatabase.net/og-image/k254253-loqteq-va-proximal-humerus-plate-35-fda-510k.jpg K254253 - LOQTEQ® VA Proximal Humerus Plate 3.5 K254253 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aap Implantate AG. Cleared Mar 2026. https://www.510kdatabase.net/k260087/ 2026-03-24 monthly 0.8 https://www.510kdatabase.net/og-image/k260087-senographe-pristina-fda-510k.jpg K260087 - Senographe Pristina K260087 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems SCS. Cleared Mar 2026. https://www.510kdatabase.net/k260673/ 2026-03-24 monthly 0.8 https://www.510kdatabase.net/og-image/k260673-logiq-vita-fda-510k.jpg K260673 - LOGIQ Vita K260673 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared Mar 2026. https://www.510kdatabase.net/k260787/ 2026-03-24 monthly 0.8 https://www.510kdatabase.net/og-image/k260787-febridx-bacterialnon-bacterial-assay-fda-510k.jpg K260787 - FebriDx Bacterial/Non-bacterial Assay K260787 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Lumos Diagnostics, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k252031/ 2026-03-23 monthly 0.8 https://www.510kdatabase.net/og-image/k252031-adin-long-dental-implant-system-fda-510k.jpg K252031 - Adin Long Dental Implant System K252031 is a FDA 510(k) cleared dental medical device. Manufacturer: Adin Dental Implant Systems , Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k252992/ 2026-03-23 monthly 0.8 https://www.510kdatabase.net/og-image/k252992-ct-rembra-rt-fda-510k.jpg K252992 - CT Rembra RT K252992 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Healthcare (Suzhou) Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k253686/ 2026-03-23 monthly 0.8 https://www.510kdatabase.net/og-image/k253686-true-definition-dl-fda-510k.jpg K253686 - True Definition DL K253686 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare Japan Corporation. Cleared Mar 2026. https://www.510kdatabase.net/k254166/ 2026-03-23 monthly 0.8 https://www.510kdatabase.net/og-image/k254166-mdx-chex-for-bcn-fda-510k.jpg K254166 - MDx-Chex for BCN K254166 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Streck. Cleared Mar 2026. https://www.510kdatabase.net/k254275/ 2026-03-23 monthly 0.8 https://www.510kdatabase.net/og-image/k254275-hypersuture-all-green-extension-line-fda-510k.jpg K254275 - HyperSuture All Green Extension Line K254275 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Threadstone, LLC. Cleared Mar 2026. https://www.510kdatabase.net/k254288/ 2026-03-23 monthly 0.8 https://www.510kdatabase.net/og-image/k254288-clavicle-fixation-system-fda-510k.jpg K254288 - Clavicle Fixation System K254288 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Skeletal Dynamics, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k260112/ 2026-03-23 monthly 0.8 https://www.510kdatabase.net/og-image/k260112-quikfix-external-fixator-knee-spanning-fda-510k.jpg K260112 - QuikFix External Fixator: Knee-Spanning Pack K260112 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stabiliz Orthopaedics, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k260202/ 2026-03-23 monthly 0.8 https://www.510kdatabase.net/og-image/k260202-led-light-therapy-masks-lumilips-fac07na-fda-510k.jpg K260202 - LED Light Therapy Masks (LumiLips FAC07NA) K260202 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Guangdong Newdermo Biotech Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k251937/ 2026-03-20 monthly 0.8 https://www.510kdatabase.net/og-image/k251937-nordicaudio-10-fda-510k.jpg K251937 - nordicAudio (1.0) K251937 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nordicneurolab AS. Cleared Mar 2026. https://www.510kdatabase.net/k251950/ 2026-03-20 monthly 0.8 https://www.510kdatabase.net/og-image/k251950-endobronchial-blocker-tube-ebt0109-fda-510k.jpg K251950 - Endobronchial Blocker Tube (EBT0109) K251950 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Hangzhou Tappa Medical Technology Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k251980/ 2026-03-20 monthly 0.8 https://www.510kdatabase.net/og-image/k251980-claveqs-bag-fda-510k.jpg K251980 - ClaveQS™ Bag K251980 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Icu Medical, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k252005/ 2026-03-20 monthly 0.8 https://www.510kdatabase.net/og-image/k252005-livi-device-fda-510k.jpg K252005 - Livi Device K252005 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Liviwell, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k252016/ 2026-03-20 monthly 0.8 https://www.510kdatabase.net/og-image/k252016-arthrex-humeral-nails-fda-510k.jpg K252016 - Arthrex Humeral Nails K252016 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k252050/ 2026-03-20 monthly 0.8 https://www.510kdatabase.net/og-image/k252050-disposable-biopsy-forceps-fb-211d-fb-fda-510k.jpg K252050 - Disposable Biopsy Forceps FB-211D, FB-221D, FB-231D, FB-241D K252050 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Olympus Medical Systems Corporation. Cleared Mar 2026. https://www.510kdatabase.net/k252358/ 2026-03-20 monthly 0.8 https://www.510kdatabase.net/og-image/k252358-nexstim-navigated-brain-stimulation-fda-510k.jpg K252358 - Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) K252358 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nexstim Oyj. Cleared Mar 2026. https://www.510kdatabase.net/k252606/ 2026-03-20 monthly 0.8 https://www.510kdatabase.net/og-image/k252606-bifix-veneer-lc-bifix-veneer-try-in-fda-510k.jpg K252606 - Bifix Veneer LC, Bifix Veneer Try-In K252606 is a FDA 510(k) cleared dental medical device. Manufacturer: Voco GmbH. Cleared Mar 2026. https://www.510kdatabase.net/k253098/ 2026-03-20 monthly 0.8 https://www.510kdatabase.net/og-image/k253098-nexstim-navigated-brain-stimulation-fda-510k.jpg K253098 - Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) K253098 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nexstim Oyj. Cleared Mar 2026. https://www.510kdatabase.net/k253520/ 2026-03-20 monthly 0.8 https://www.510kdatabase.net/og-image/k253520-photonova-spectra-photonova-spectra-fda-510k.jpg K253520 - Photonova Spectra, Photonova Spectra Select K253520 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems, LLC. Cleared Mar 2026. https://www.510kdatabase.net/k253574/ 2026-03-20 monthly 0.8 https://www.510kdatabase.net/og-image/k253574-somatom-xcite-fda-510k.jpg K253574 - SOMATOM X.cite K253574 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k253604/ 2026-03-20 monthly 0.8 https://www.510kdatabase.net/og-image/k253604-tilink-l-navigation-instruments-fda-510k.jpg K253604 - TiLink-L Navigation Instruments K253604 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SurGenTec, LLC. Cleared Mar 2026. https://www.510kdatabase.net/k253849/ 2026-03-20 monthly 0.8 https://www.510kdatabase.net/og-image/k253849-electric-wheelchair-jjw-7002-jjw-7003-fda-510k.jpg K253849 - Electric wheelchair (JJW-7002, JJW-7003) K253849 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: ZheJiang J&J Mobility Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k253864/ 2026-03-20 monthly 0.8 https://www.510kdatabase.net/og-image/k253864-nomad-pro-3-fda-510k.jpg K253864 - NOMAD Pro 3 K253864 is a FDA 510(k) cleared radiology medical device. Manufacturer: Dental Imaging Technologies Corporation. Cleared Mar 2026. https://www.510kdatabase.net/k254170/ 2026-03-20 monthly 0.8 https://www.510kdatabase.net/og-image/k254170-percutaneous-endoscopic-gastrostomy-fda-510k.jpg K254170 - Percutaneous Endoscopic Gastrostomy (PEG) Kit K254170 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Degania Silicone , Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k254208/ 2026-03-20 monthly 0.8 https://www.510kdatabase.net/og-image/k254208-flowrunner-aspiration-system-fda-510k.jpg K254208 - FLOWRUNNER Aspiration System K254208 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Expanse Medical, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k260437/ 2026-03-20 monthly 0.8 https://www.510kdatabase.net/og-image/k260437-valvuloplasty-balloon-catheter-fda-510k.jpg K260437 - Valvuloplasty Balloon Catheter (ValvuloPro) K260437 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Dongguan TT Medical, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k260519/ 2026-03-20 monthly 0.8 https://www.510kdatabase.net/og-image/k260519-smart-fit-torsocardiac-15t-fda-510k.jpg K260519 - Smart Fit TorsoCardiac 1.5T K260519 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Healthcare (Suzhou) Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k260544/ 2026-03-20 monthly 0.8 https://www.510kdatabase.net/og-image/k260544-fmd-peripheral-guide-wire-f-14-flex-6-fda-510k.jpg K260544 - FMD Peripheral Guide Wire F-14 Flex 6 K260544 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: FMD Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k260551/ 2026-03-20 monthly 0.8 https://www.510kdatabase.net/og-image/k260551-hemosil-factor-v-leiden-apc-resistance-v-fda-510k.jpg K260551 - HemosIL Factor V Leiden (APC Resistance V) K260551 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory (IL) Co.. Cleared Mar 2026. https://www.510kdatabase.net/k260561/ 2026-03-20 monthly 0.8 https://www.510kdatabase.net/og-image/k260561-arthrex-fibertak-suture-anchor-fda-510k.jpg K260561 - Arthrex FiberTak Suture Anchor K260561 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k260585/ 2026-03-20 monthly 0.8 https://www.510kdatabase.net/og-image/k260585-noxturnal-web-fda-510k.jpg K260585 - Noxturnal Web K260585 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nox Medical Ehf. Cleared Mar 2026. https://www.510kdatabase.net/k252101/ 2026-03-19 monthly 0.8 https://www.510kdatabase.net/og-image/k252101-jwg-1-fda-510k.jpg K252101 - JWG-1 K252101 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Yamaha Motor Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k253139/ 2026-03-19 monthly 0.8 https://www.510kdatabase.net/og-image/k253139-disposable-distal-cap-fda-510k.jpg K253139 - Disposable Distal Cap K253139 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Mirco-Tech (Nanjing) Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k253432/ 2026-03-19 monthly 0.8 https://www.510kdatabase.net/og-image/k253432-diversivy-facet-screw-system-fda-510k.jpg K253432 - DiversiVy™ Facet Screw System K253432 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Vy Spine, LLC. Cleared Mar 2026. https://www.510kdatabase.net/k253746/ 2026-03-19 monthly 0.8 https://www.510kdatabase.net/og-image/k253746-enroute-0014-transcarotid-guidewire-fda-510k.jpg K253746 - Enroute 0.014'' Transcarotid Guidewire K253746 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Lake Region Medical. Cleared Mar 2026. https://www.510kdatabase.net/k253965/ 2026-03-19 monthly 0.8 https://www.510kdatabase.net/og-image/k253965-curelight-medical-diode-laser-systems-fda-510k.jpg K253965 - CureLight Medical Diode Laser Systems (CureLight F2-A15 K253965 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wuhan PHOMED Technology Company , Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k254112/ 2026-03-19 monthly 0.8 https://www.510kdatabase.net/og-image/k254112-dia-x-sil-bite-fda-510k.jpg K254112 - Dia-X Sil Bite K254112 is a FDA 510(k) cleared dental medical device. Manufacturer: DiaDent Group International. Cleared Mar 2026. https://www.510kdatabase.net/k254269/ 2026-03-19 monthly 0.8 https://www.510kdatabase.net/og-image/k254269-saview-sh-optic-38-uv-senofilcon-a-fda-510k.jpg K254269 - Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens K254269 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: St. shine Optical Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k260448/ 2026-03-19 monthly 0.8 https://www.510kdatabase.net/og-image/k260448-castleloc-pectus-bar-system-fda-510k.jpg K260448 - CastleLoc Pectus Bar System K260448 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: L & K Biomed Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k260509/ 2026-03-19 monthly 0.8 https://www.510kdatabase.net/og-image/k260509-autocontour-radac-v5-fda-510k.jpg K260509 - AutoContour (RADAC V5) K260509 is a FDA 510(k) cleared radiology medical device. Manufacturer: Radformation, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k260532/ 2026-03-19 monthly 0.8 https://www.510kdatabase.net/og-image/k260532-derma-gide-fda-510k.jpg K260532 - Derma-Gide K260532 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Geistlich Pharma AG. Cleared Mar 2026. https://www.510kdatabase.net/k260533/ 2026-03-19 monthly 0.8 https://www.510kdatabase.net/og-image/k260533-elisio-h-fda-510k.jpg K260533 - ELISIO™-H K260533 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Nipro Medical Corporation. Cleared Mar 2026. https://www.510kdatabase.net/k260537/ 2026-03-19 monthly 0.8 https://www.510kdatabase.net/og-image/k260537-willow-24-guidewire-fda-510k.jpg K260537 - Willow 24 Guidewire K260537 is a FDA 510(k) cleared neurology medical device. Manufacturer: Arbor Endovascular, LLC. Cleared Mar 2026. https://www.510kdatabase.net/k251967/ 2026-03-18 monthly 0.8 https://www.510kdatabase.net/og-image/k251967-halyard-fluidshield-3-fog-free-fda-510k.jpg K251967 - HALYARD* FLUIDSHIELD* 3 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops K251967 is a FDA 510(k) cleared general hospital medical device. Manufacturer: O&M Halyard, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k252304/ 2026-03-18 monthly 0.8 https://www.510kdatabase.net/og-image/k252304-syngovia-rt-image-suite-vc10-fda-510k.jpg K252304 - syngo.via RT Image Suite VC10 K252304 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k252961/ 2026-03-18 monthly 0.8 https://www.510kdatabase.net/og-image/k252961-fusion-fibfix-nail-fda-510k.jpg K252961 - Fusion FibFix Nail K252961 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Fusion Orthopedics USA, LLC. Cleared Mar 2026. https://www.510kdatabase.net/k253012/ 2026-03-18 monthly 0.8 https://www.510kdatabase.net/og-image/k253012-alignrt-plus-80-fda-510k.jpg K253012 - AlignRT Plus (8.0) K253012 is a FDA 510(k) cleared radiology medical device. Manufacturer: Vision Rt, Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k253444/ 2026-03-18 monthly 0.8 https://www.510kdatabase.net/og-image/k253444-europa-posterior-cervical-fusion-fda-510k.jpg K253444 - EUROPA™ Posterior Cervical Fusion Navigated Instruments K253444 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: MiRus, LLC. Cleared Mar 2026. https://www.510kdatabase.net/k253622/ 2026-03-18 monthly 0.8 https://www.510kdatabase.net/og-image/k253622-safety-pen-needle-fda-510k.jpg K253622 - Safety Pen Needle K253622 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ningbo Medsun Medical Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k253834/ 2026-03-18 monthly 0.8 https://www.510kdatabase.net/og-image/k253834-visuref-600-fda-510k.jpg K253834 - VISUREF 600 K253834 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Carl Zeiss Vision GmbH. Cleared Mar 2026. https://www.510kdatabase.net/k254110/ 2026-03-18 monthly 0.8 https://www.510kdatabase.net/og-image/k254110-dynanail-mini-fda-510k.jpg K254110 - DynaNail Mini K254110 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: MedShape, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k260188/ 2026-03-18 monthly 0.8 https://www.510kdatabase.net/og-image/k260188-limflow-vector-fda-510k.jpg K260188 - LimFlow Vector K260188 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: LimFlow, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k260830/ 2026-03-18 monthly 0.8 https://www.510kdatabase.net/og-image/k260830-apapro-desensitizer-homecare-fda-510k.jpg K260830 - APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste) K260830 is a FDA 510(k) cleared dental medical device. Manufacturer: Sangi Co, Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k251926/ 2026-03-17 monthly 0.8 https://www.510kdatabase.net/og-image/k251926-encore-impression-material-fda-510k.jpg K251926 - enCore Impression Material K251926 is a FDA 510(k) cleared dental medical device. Manufacturer: Encore Guards. Cleared Mar 2026. https://www.510kdatabase.net/k252078/ 2026-03-17 monthly 0.8 https://www.510kdatabase.net/og-image/k252078-breathepal-bilevel-gfm50-md2201-fda-510k.jpg K252078 - BreathePal Bilevel (GFM50-MD2201) K252078 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Compal Electronics, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k252813/ 2026-03-17 monthly 0.8 https://www.510kdatabase.net/og-image/k252813-electrical-scooter-sm4226-fda-510k.jpg K252813 - Electrical Scooter (SM4226) K252813 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Lerado Zhongshan Peaceful Cove Business Trading Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k252971/ 2026-03-17 monthly 0.8 https://www.510kdatabase.net/og-image/k252971-elyra-thulium-fiber-laser-system-and-fda-510k.jpg K252971 - Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories) K252971 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k253587/ 2026-03-17 monthly 0.8 https://www.510kdatabase.net/og-image/k253587-cala-kiq-plus-fda-510k.jpg K253587 - Cala kIQ Plus K253587 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cala Health, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k253614/ 2026-03-17 monthly 0.8 https://www.510kdatabase.net/og-image/k253614-echonavigator-r50-fda-510k.jpg K253614 - EchoNavigator R5.0 K253614 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Mar 2026. https://www.510kdatabase.net/k253750/ 2026-03-17 monthly 0.8 https://www.510kdatabase.net/og-image/k253750-btl-785neh-fda-510k.jpg K253750 - BTL-785NEH K253750 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: BTL Industries, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k253863/ 2026-03-17 monthly 0.8 https://www.510kdatabase.net/og-image/k253863-guardian-quick-dip-residual-chlorine-fda-510k.jpg K253863 - GUARDIAN™ Quick Dip Residual Chlorine (5212) K253863 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Serim Research. Cleared Mar 2026. https://www.510kdatabase.net/k253886/ 2026-03-17 monthly 0.8 https://www.510kdatabase.net/og-image/k253886-grappler-suture-anchor-pcfd-tether-fda-510k.jpg K253886 - Grappler Suture Anchor PCFD Tether System K253886 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paragon 28, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k254053/ 2026-03-17 monthly 0.8 https://www.510kdatabase.net/og-image/k254053-aps-spear-locking-plate-fda-510k.jpg K254053 - APS Spear Locking Plate K254053 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: A Plus Biotechnology Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k254167/ 2026-03-17 monthly 0.8 https://www.510kdatabase.net/og-image/k254167-mdx-chex-for-bcy-fda-510k.jpg K254167 - MDx-Chex for BCY K254167 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Streck, LLC. Cleared Mar 2026. https://www.510kdatabase.net/k260390/ 2026-03-17 monthly 0.8 https://www.510kdatabase.net/og-image/k260390-super-upper-limbs-versalock-plating-fda-510k.jpg K260390 - Super Upper Limbs Versalock Plating System K260390 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: GM Dos Reis Industria e Comercio Ltda.. Cleared Mar 2026. https://www.510kdatabase.net/k260546/ 2026-03-17 monthly 0.8 https://www.510kdatabase.net/og-image/k260546-q-pedicle-instruments-fda-510k.jpg K260546 - Q Pedicle Instruments K260546 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: K2m, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k260632/ 2026-03-17 monthly 0.8 https://www.510kdatabase.net/og-image/k260632-laser-thermal-therapy-kit-fda-510k.jpg K260632 - LASER THERMAL THERAPY KIT K260632 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Elesta S.P.A. Cleared Mar 2026. https://www.510kdatabase.net/den250014/ 2026-03-17 monthly 0.8 https://www.510kdatabase.net/og-image/den250014-tyto-insights-for-eardrum-bulging-fda-510k.jpg DEN250014 - Tyto Insights for Eardrum Bulging Detection DEN250014 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Tyto Care , Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k252122/ 2026-03-16 monthly 0.8 https://www.510kdatabase.net/og-image/k252122-dcwire-micro-guidewire-fda-510k.jpg K252122 - DCwire Micro-guidewire K252122 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shanghai Achieva Medical Suzhou Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k252282/ 2026-03-16 monthly 0.8 https://www.510kdatabase.net/og-image/k252282-surgicount-system-fda-510k.jpg K252282 - SurgiCount+ System K252282 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Stryker Instruments. Cleared Mar 2026. https://www.510kdatabase.net/k252433/ 2026-03-16 monthly 0.8 https://www.510kdatabase.net/og-image/k252433-sonio-detect-v3-fda-510k.jpg K252433 - Sonio Detect (v3) K252433 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sonio. Cleared Mar 2026. https://www.510kdatabase.net/k253334/ 2026-03-16 monthly 0.8 https://www.510kdatabase.net/og-image/k253334-zenex-implant-systemshort-r-system-fda-510k.jpg K253334 - ZENEX Implant System_Short (R-System) K253334 is a FDA 510(k) cleared dental medical device. Manufacturer: Izenimplant Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k253395/ 2026-03-16 monthly 0.8 https://www.510kdatabase.net/og-image/k253395-stealth-axis-ent-clinical-application-fda-510k.jpg K253395 - Stealth AXiS™ ENT clinical application K253395 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Medtronic Navigation, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k253447/ 2026-03-16 monthly 0.8 https://www.510kdatabase.net/og-image/k253447-montage-flowable-settable-resorbable-fda-510k.jpg K253447 - Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover) K253447 is a FDA 510(k) cleared neurology medical device. Manufacturer: Orthocon, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k253590/ 2026-03-16 monthly 0.8 https://www.510kdatabase.net/og-image/k253590-millipede-system-fda-510k.jpg K253590 - Millipede System K253590 is a FDA 510(k) cleared neurology medical device. Manufacturer: Perfuze, Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k253705/ 2026-03-16 monthly 0.8 https://www.510kdatabase.net/og-image/k253705-healgen-accurate-oral-fluid-drug-test-fda-510k.jpg K253705 - Healgen® Accurate Oral Fluid Drug Test K253705 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Healgen Scientific, LLC. Cleared Mar 2026. https://www.510kdatabase.net/k253838/ 2026-03-16 monthly 0.8 https://www.510kdatabase.net/og-image/k253838-lifemotion-disposable-membrane-fda-510k.jpg K253838 - Lifemotion Disposable Membrane Oxygenator K253838 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Lifemotion Medical Technology Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k253916/ 2026-03-16 monthly 0.8 https://www.510kdatabase.net/og-image/k253916-aptus-shoulder-proximal-humerus-system-fda-510k.jpg K253916 - APTUS Shoulder Proximal Humerus System, PentaLock 3.5 K253916 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medartis AG. Cleared Mar 2026. https://www.510kdatabase.net/k253944/ 2026-03-16 monthly 0.8 https://www.510kdatabase.net/og-image/k253944-data-analysis-facilitation-suite-dafs-fda-510k.jpg K253944 - Data Analysis Facilitation Suite (DAFS) K253944 is a FDA 510(k) cleared radiology medical device. Manufacturer: Voronoi Health Analytics Incorporated. Cleared Mar 2026. https://www.510kdatabase.net/k254045/ 2026-03-16 monthly 0.8 https://www.510kdatabase.net/og-image/k254045-carboclear-posterior-cervical-screw-fda-510k.jpg K254045 - CarboClear® Posterior Cervical Screw System K254045 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: CarboFix Orthopedics , Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k254079/ 2026-03-16 monthly 0.8 https://www.510kdatabase.net/og-image/k254079-led-light-therapy-mask-models-t2-rld10-fda-510k.jpg K254079 - LED Light Therapy Mask (Models: T2, RLD10) K254079 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Desida Technology Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k254176/ 2026-03-16 monthly 0.8 https://www.510kdatabase.net/og-image/k254176-sinefix-fda-510k.jpg K254176 - SINEFIX K254176 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: BAAT Medical Products B.V.. Cleared Mar 2026. https://www.510kdatabase.net/k260511/ 2026-03-16 monthly 0.8 https://www.510kdatabase.net/og-image/k260511-ulike-reglow-light-therapy-device-um10-fda-510k.jpg K260511 - Ulike Reglow Light Therapy Device (UM10) K260511 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Ulike Smart Electronics Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k253581/ 2026-03-15 monthly 0.8 https://www.510kdatabase.net/og-image/k253581-disposable-concentric-needle-electrode-fda-510k.jpg K253581 - Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001) K253581 is a FDA 510(k) cleared neurology medical device. Manufacturer: Technomed Europe. Cleared Mar 2026. https://www.510kdatabase.net/k251848/ 2026-03-13 monthly 0.8 https://www.510kdatabase.net/og-image/k251848-pentacam-cornea-oct-fda-510k.jpg K251848 - Pentacam® Cornea OCT K251848 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Oculus Optikger?te GmbH. Cleared Mar 2026. https://www.510kdatabase.net/k251916/ 2026-03-13 monthly 0.8 https://www.510kdatabase.net/og-image/k251916-genbody-covid-19-ag-home-test-fda-510k.jpg K251916 - GenBody COVID-19 Ag Home Test K251916 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Genbody.Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k251999/ 2026-03-13 monthly 0.8 https://www.510kdatabase.net/og-image/k251999-promogran-prisma-collagen-matrix-with-fda-510k.jpg K251999 - Promogran Prisma™ Collagen Matrix with ORC and Silver K251999 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Solventum Germany GmbH. Cleared Mar 2026. https://www.510kdatabase.net/k252040/ 2026-03-13 monthly 0.8 https://www.510kdatabase.net/og-image/k252040-bd-vacutainer-plasma-separator-tubes-fda-510k.jpg K252040 - BD Vacutainer® Plasma Separator Tubes (PST™), BD Vacutainer® Sodium Heparin Blood Collection Tubes K252040 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Becton, Dickinson and Company. Cleared Mar 2026. https://www.510kdatabase.net/k252249/ 2026-03-13 monthly 0.8 https://www.510kdatabase.net/og-image/k252249-extremity-ct-imaging-system-fda-510k.jpg K252249 - Extremity CT Imaging System K252249 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mars Bioimaging , Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k252261/ 2026-03-13 monthly 0.8 https://www.510kdatabase.net/og-image/k252261-infercare-recist-fda-510k.jpg K252261 - InferCare RECIST K252261 is a FDA 510(k) cleared radiology medical device. Manufacturer: Beijing Infervision Healthcare Medical Technology Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k252385/ 2026-03-13 monthly 0.8 https://www.510kdatabase.net/og-image/k252385-pegavision-toufilcon-b-daily-fda-510k.jpg K252385 - Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses K252385 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Pegavision Corporation. Cleared Mar 2026. https://www.510kdatabase.net/k252648/ 2026-03-13 monthly 0.8 https://www.510kdatabase.net/og-image/k252648-niti-s-spaxus-stent-fda-510k.jpg K252648 - Niti-S SPAXUS Stent K252648 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Taewoong Medical Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k252923/ 2026-03-13 monthly 0.8 https://www.510kdatabase.net/og-image/k252923-iasis-i2-relaxation-neurofeedback-system-fda-510k.jpg K252923 - IASIS i2 Relaxation Neurofeedback System K252923 is a FDA 510(k) cleared neurology medical device. Manufacturer: Iasis Technologies. Cleared Mar 2026. https://www.510kdatabase.net/k253111/ 2026-03-13 monthly 0.8 https://www.510kdatabase.net/og-image/k253111-aeka-imaging-fda-510k.jpg K253111 - Aeka Imaging K253111 is a FDA 510(k) cleared radiology medical device. Manufacturer: Good Methods Global, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k253205/ 2026-03-13 monthly 0.8 https://www.510kdatabase.net/og-image/k253205-optimap-catheter-50mm-opti-cath2-50-fda-510k.jpg K253205 - OptiMap Catheter - 50mm (OPTI-CATH2-50) K253205 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cortex, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k253261/ 2026-03-13 monthly 0.8 https://www.510kdatabase.net/og-image/k253261-apollo-quattro-apq-10m-fda-510k.jpg K253261 - Apollo Quattro (APQ-10M) K253261 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Weero Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k253391/ 2026-03-13 monthly 0.8 https://www.510kdatabase.net/og-image/k253391-visualase-cooled-laser-applicator-fda-510k.jpg K253391 - Visualase Cooled Laser Applicator System (9735559) K253391 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Navigation, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k253732/ 2026-03-13 monthly 0.8 https://www.510kdatabase.net/og-image/k253732-permatage-flowable-settable-bone-paste-fda-510k.jpg K253732 - Permatage Flowable, Settable Bone Paste K253732 is a FDA 510(k) cleared neurology medical device. Manufacturer: Orthocon, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k253799/ 2026-03-13 monthly 0.8 https://www.510kdatabase.net/og-image/k253799-safesept-rf-transseptal-guidewire-fda-510k.jpg K253799 - SafeSept RF Transseptal Guidewire (SSRF132 K253799 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Pressure Products Medical Device Manufacturing, LLC. Cleared Mar 2026. https://www.510kdatabase.net/k253987/ 2026-03-13 monthly 0.8 https://www.510kdatabase.net/og-image/k253987-bare-wireguided-balloon-dilation-fda-510k.jpg K253987 - BARE Wireguided Balloon Dilation Catheter (1235) K253987 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: GIE Medical. Cleared Mar 2026. https://www.510kdatabase.net/k254059/ 2026-03-13 monthly 0.8 https://www.510kdatabase.net/og-image/k254059-access-anti-hbc-igm-fda-510k.jpg K254059 - Access anti-HBc IgM K254059 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k254277/ 2026-03-13 monthly 0.8 https://www.510kdatabase.net/og-image/k254277-embrace-neonatal-mri-system-fda-510k.jpg K254277 - Embrace Neonatal MRI System K254277 is a FDA 510(k) cleared radiology medical device. Manufacturer: Aspect Imaging, Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k260078/ 2026-03-13 monthly 0.8 https://www.510kdatabase.net/og-image/k260078-aquilion-servesp-tsx-307b-v20-fda-510k.jpg K260078 - Aquilion ServeSP (TSX-307B) V2.0 K260078 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Mar 2026. https://www.510kdatabase.net/k260147/ 2026-03-13 monthly 0.8 https://www.510kdatabase.net/og-image/k260147-electric-nasal-aspirator-bc026-bc025-fda-510k.jpg K260147 - Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036) K260147 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Shenzhen Kingboom Technology Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k260455/ 2026-03-13 monthly 0.8 https://www.510kdatabase.net/og-image/k260455-new-wave-system-fda-510k.jpg K260455 - New Wave System K260455 is a FDA 510(k) cleared neurology medical device. Manufacturer: Zeto, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k260479/ 2026-03-13 monthly 0.8 https://www.510kdatabase.net/og-image/k260479-therasphere-360-y-90-management-platform-fda-510k.jpg K260479 - TheraSphere 360™ Y-90 Management Platform K260479 is a FDA 510(k) cleared radiology medical device. Manufacturer: Boston Scientific Corporation. Cleared Mar 2026. https://www.510kdatabase.net/k260499/ 2026-03-13 monthly 0.8 https://www.510kdatabase.net/og-image/k260499-amplatzer-trevisio-intravascular-fda-510k.jpg K260499 - Amplatzer™ Trevisio™ Intravascular Delivery System K260499 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared Mar 2026. https://www.510kdatabase.net/k240934/ 2026-03-12 monthly 0.8 https://www.510kdatabase.net/og-image/k240934-quantum-perfusion-blood-oxygenator-ecc-fda-510k.jpg K240934 - Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3) K240934 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Spectrum Medical S.R.L.. Cleared Mar 2026. https://www.510kdatabase.net/k250655/ 2026-03-12 monthly 0.8 https://www.510kdatabase.net/og-image/k250655-deep-capsule-deep-capsule-us-fda-510k.jpg K250655 - Deep Capsule® (Deep Capsule US) K250655 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Digestaid - Artificial Intelligence Development SA. Cleared Mar 2026. https://www.510kdatabase.net/k250794/ 2026-03-12 monthly 0.8 https://www.510kdatabase.net/og-image/k250794-invera-infusion-device-fda-510k.jpg K250794 - InVera Infusion Device K250794 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Invera Medical. Cleared Mar 2026. https://www.510kdatabase.net/k251584/ 2026-03-12 monthly 0.8 https://www.510kdatabase.net/og-image/k251584-medical-mesh-nebulizer-airicu-max-fda-510k.jpg K251584 - Medical Mesh Nebulizer (AirICU Max+) K251584 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: AIRICU, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k251750/ 2026-03-12 monthly 0.8 https://www.510kdatabase.net/og-image/k251750-trax-ex-anchor-fda-510k.jpg K251750 - Trax EX Anchor K251750 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Trax Surgical, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k251888/ 2026-03-12 monthly 0.8 https://www.510kdatabase.net/og-image/k251888-vpap-pediatric-face-mask-fda-510k.jpg K251888 - VPAP Pediatric Face Mask K251888 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Hsiner Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k251964/ 2026-03-12 monthly 0.8 https://www.510kdatabase.net/og-image/k251964-mimics-thoracic-planner-fda-510k.jpg K251964 - Mimics Thoracic Planner K251964 is a FDA 510(k) cleared radiology medical device. Manufacturer: Materialise NV. Cleared Mar 2026. https://www.510kdatabase.net/k252089/ 2026-03-12 monthly 0.8 https://www.510kdatabase.net/og-image/k252089-tyto-stethoscope-g3-fda-510k.jpg K252089 - Tyto Stethoscope (G3) K252089 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Tyto Care , Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k252110/ 2026-03-12 monthly 0.8 https://www.510kdatabase.net/og-image/k252110-dental-x-ray-unit-ajx200-fda-510k.jpg K252110 - Dental X-RAY Unit (AJX200) K252110 is a FDA 510(k) cleared radiology medical device. Manufacturer: Guangzhou Ajax Medical Equipment Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k252401/ 2026-03-12 monthly 0.8 https://www.510kdatabase.net/og-image/k252401-implafit-short-stems-fda-510k.jpg K252401 - implaFit® short stems K252401 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Implantcast GmbH. Cleared Mar 2026. https://www.510kdatabase.net/k252541/ 2026-03-12 monthly 0.8 https://www.510kdatabase.net/og-image/k252541-quantum-pureflow-standard-heat-fda-510k.jpg K252541 - Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W K252541 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Spectrum Medical S.R.L.. Cleared Mar 2026. https://www.510kdatabase.net/k252546/ 2026-03-12 monthly 0.8 https://www.510kdatabase.net/og-image/k252546-vantagetm-lumbar-decompression-kit-fda-510k.jpg K252546 - VantageTM Lumbar Decompression Kit K252546 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Allevion Medical, LLC. Cleared Mar 2026. https://www.510kdatabase.net/k252583/ 2026-03-12 monthly 0.8 https://www.510kdatabase.net/og-image/k252583-mini-moon-electric-breast-pump-pa221-fda-510k.jpg K252583 - Mini Moon electric breast pump (PA221) K252583 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: A Cute Baby, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k252824/ 2026-03-12 monthly 0.8 https://www.510kdatabase.net/og-image/k252824-evolve-ap-cup-world-finned-cup-world-g-fda-510k.jpg K252824 - Evolve AP Cup, World Finned Cup, World G-Zero Liner and Oddball Femoral Head K252824 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Signature Orthopaedics Pty, Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k253062/ 2026-03-12 monthly 0.8 https://www.510kdatabase.net/og-image/k253062-tigertriever-25-revascularization-device-fda-510k.jpg K253062 - Tigertriever 25 Revascularization Device K253062 is a FDA 510(k) cleared neurology medical device. Manufacturer: Rapid Medical , Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k253429/ 2026-03-12 monthly 0.8 https://www.510kdatabase.net/og-image/k253429-genadyne-astra-npwt-fda-510k.jpg K253429 - Genadyne ASTRA NPWT K253429 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Genadyne Biotechnologies, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k253525/ 2026-03-12 monthly 0.8 https://www.510kdatabase.net/og-image/k253525-urocross-expander-system-model-numbers-fda-510k.jpg K253525 - Urocross Expander System (Model Numbers ES2018 and ES3025) K253525 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Prodeon Medical, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k253566/ 2026-03-12 monthly 0.8 https://www.510kdatabase.net/og-image/k253566-affixus-retrograde-femoral-nailing-fda-510k.jpg K253566 - Affixus Retrograde Femoral Nailing System K253566 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k253636/ 2026-03-12 monthly 0.8 https://www.510kdatabase.net/og-image/k253636-zionic-pro-max-ems-fda-510k.jpg K253636 - Zionic Pro Max (EMS) K253636 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Termosalud S.L.. Cleared Mar 2026. https://www.510kdatabase.net/k253734/ 2026-03-12 monthly 0.8 https://www.510kdatabase.net/og-image/k253734-taurus-clip-fda-510k.jpg K253734 - Taurus Clip K253734 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Taurus Endoscopy. Cleared Mar 2026. https://www.510kdatabase.net/k253743/ 2026-03-12 monthly 0.8 https://www.510kdatabase.net/og-image/k253743-minimed-flex-pump-fda-510k.jpg K253743 - MiniMed Flex pump K253743 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Medtronic Minimed, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k253936/ 2026-03-12 monthly 0.8 https://www.510kdatabase.net/og-image/k253936-power-mobility-scooter-mjma01-mjma02-fda-510k.jpg K253936 - Power Mobility Scooter (MJMA01, MJMA02) K253936 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Nanjing Mijo Technology Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k254040/ 2026-03-12 monthly 0.8 https://www.510kdatabase.net/og-image/k254040-lungflow-basket-catheter-fda-510k.jpg K254040 - LungFlow Basket Catheter K254040 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Free Flow Medical, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k254233/ 2026-03-12 monthly 0.8 https://www.510kdatabase.net/og-image/k254233-medpor-customized-implant-kit-fda-510k.jpg K254233 - MEDPOR Customized Implant Kit K254233 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker Leibinger GmbH & Co KG. Cleared Mar 2026. https://www.510kdatabase.net/k260453/ 2026-03-12 monthly 0.8 https://www.510kdatabase.net/og-image/k260453-remote-wave-electrode-ae03-50-fda-510k.jpg K260453 - Remote Wave Electrode (AE03-50) K260453 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Bionit Labs Srl. Cleared Mar 2026. https://www.510kdatabase.net/k260502/ 2026-03-12 monthly 0.8 https://www.510kdatabase.net/og-image/k260502-liv-pre-lubricated-intermittent-catheter-fda-510k.jpg K260502 - Liv Pre-lubricated Intermittent Catheter K260502 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: HR Healthcare. Cleared Mar 2026. https://www.510kdatabase.net/k250937/ 2026-03-11 monthly 0.8 https://www.510kdatabase.net/og-image/k250937-venous-return-cannulae-fda-510k.jpg K250937 - Venous Return Cannulae K250937 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: LivaNova USA, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k252028/ 2026-03-11 monthly 0.8 https://www.510kdatabase.net/og-image/k252028-luofucon-antimicrobial-wound-gel-fda-510k.jpg K252028 - LUOFUCON® Antimicrobial Wound Gel K252028 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Huizhou Foryou Medical Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k253185/ 2026-03-11 monthly 0.8 https://www.510kdatabase.net/og-image/k253185-lux-hd-detectors-drx-lc-detector-drx-fda-510k.jpg K253185 - Lux HD Detectors, DRX-LC Detector, DRX-Revolution Mobile X-Ray System K253185 is a FDA 510(k) cleared radiology medical device. Manufacturer: Carestream Health. Cleared Mar 2026. https://www.510kdatabase.net/k253624/ 2026-03-11 monthly 0.8 https://www.510kdatabase.net/og-image/k253624-inhance-reverse-shoulder-system-fda-510k.jpg K253624 - INHANCE™ Reverse Shoulder System K253624 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Ireland UC. Cleared Mar 2026. https://www.510kdatabase.net/k253693/ 2026-03-11 monthly 0.8 https://www.510kdatabase.net/og-image/k253693-strut-suture-fda-510k.jpg K253693 - Strut Suture K253693 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Riverpoint Medical, LLC. Cleared Mar 2026. https://www.510kdatabase.net/k253906/ 2026-03-11 monthly 0.8 https://www.510kdatabase.net/og-image/k253906-xpert-hand-fda-510k.jpg K253906 - Xpert Hand K253906 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Newclip Technics. Cleared Mar 2026. https://www.510kdatabase.net/k253986/ 2026-03-11 monthly 0.8 https://www.510kdatabase.net/og-image/k253986-da-vinci-force-feedback-instruments-fda-510k.jpg K253986 - da Vinci Force Feedback Instruments K253986 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k254047/ 2026-03-11 monthly 0.8 https://www.510kdatabase.net/og-image/k254047-hair-removal-device-ct10-ct10-pro-ct11-fda-510k.jpg K254047 - Hair Removal Device (CT10, CT10 Pro, CT11, CT11 Pro, CT12, CT12 Pro, CTU05, CTU07, CTU09, CTU012, CTU015, CTU X, DT015 Pro, DT015, DT017 Pro, DT017, DT025 Pro, DT025) K254047 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Chuangtong Yigou Technology Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k254197/ 2026-03-11 monthly 0.8 https://www.510kdatabase.net/og-image/k254197-picasso-pro-diode-laser-002-00460-fda-510k.jpg K254197 - Picasso Pro Diode Laser (002-00460) K254197 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: CAO Group, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k260783/ 2026-03-11 monthly 0.8 https://www.510kdatabase.net/og-image/k260783-venus-diamond-fda-510k.jpg K260783 - Venus Diamond K260783 is a FDA 510(k) cleared dental medical device. Manufacturer: Kulzer, LLC. Cleared Mar 2026. https://www.510kdatabase.net/k252168/ 2026-03-10 monthly 0.8 https://www.510kdatabase.net/og-image/k252168-straumann-blc-implants-indication-fda-510k.jpg K252168 - Straumann® BLC Implants - Indication Widening K252168 is a FDA 510(k) cleared dental medical device. Manufacturer: Institut Straumann AG. Cleared Mar 2026. https://www.510kdatabase.net/k252353/ 2026-03-10 monthly 0.8 https://www.510kdatabase.net/og-image/k252353-myray-proxima-x6-fda-510k.jpg K252353 - myray ProXIma X6 K252353 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cefla S.C.. Cleared Mar 2026. https://www.510kdatabase.net/k253517/ 2026-03-10 monthly 0.8 https://www.510kdatabase.net/og-image/k253517-reselute-tibial-nail-fda-510k.jpg K253517 - Reselute Tibial Nail K253517 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Reselute, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k253584/ 2026-03-10 monthly 0.8 https://www.510kdatabase.net/og-image/k253584-alphenix-infx-8000vb-infx-8000vs-v96-fda-510k.jpg K253584 - Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension) K253584 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Mar 2026. https://www.510kdatabase.net/k253953/ 2026-03-10 monthly 0.8 https://www.510kdatabase.net/og-image/k253953-ips-emax-zirconia-fda-510k.jpg K253953 - IPS e.max Zirconia K253953 is a FDA 510(k) cleared dental medical device. Manufacturer: Ivoclar Vivadent, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k254093/ 2026-03-10 monthly 0.8 https://www.510kdatabase.net/og-image/k254093-depuy-synthes-volt-medial-distal-femur-fda-510k.jpg K254093 - DePuy Synthes VOLT™ Medial Distal Femur 3.5 Plating System K254093 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes GmbH. Cleared Mar 2026. https://www.510kdatabase.net/k260595/ 2026-03-10 monthly 0.8 https://www.510kdatabase.net/og-image/k260595-sonosite-ilook-ultrasound-system-fda-510k.jpg K260595 - Sonosite iLOOK Ultrasound System K260595 is a FDA 510(k) cleared radiology medical device. Manufacturer: FUJIFILM Sonosite, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k260765/ 2026-03-10 monthly 0.8 https://www.510kdatabase.net/og-image/k260765-gemini-nova-810980-soft-tissue-laser-fda-510k.jpg K260765 - Gemini NOVA 810+980 Soft Tissue Laser K260765 is a FDA 510(k) cleared dental medical device. Manufacturer: Azena Medical, LLC. Cleared Mar 2026. https://www.510kdatabase.net/k260773/ 2026-03-10 monthly 0.8 https://www.510kdatabase.net/og-image/k260773-varios-combi-pro2-fda-510k.jpg K260773 - Varios Combi Pro2 K260773 is a FDA 510(k) cleared dental medical device. Manufacturer: Nakanishi, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k251861/ 2026-03-09 monthly 0.8 https://www.510kdatabase.net/og-image/k251861-fujifilm-endoscope-model-ed-s100tp-fda-510k.jpg K251861 - FUJIFILM Endoscope Model ED-S100TP K251861 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fujifilm Corporation. Cleared Mar 2026. https://www.510kdatabase.net/k252888/ 2026-03-09 monthly 0.8 https://www.510kdatabase.net/og-image/k252888-neosculpt-plus-fda-510k.jpg K252888 - NeoSculpt Plus K252888 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: S&M Medical Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k253189/ 2026-03-09 monthly 0.8 https://www.510kdatabase.net/og-image/k253189-persona-the-personalized-knee-system-fda-510k.jpg K253189 - Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) K253189 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k253413/ 2026-03-09 monthly 0.8 https://www.510kdatabase.net/og-image/k253413-livermultiscan-v60-fda-510k.jpg K253413 - LiverMultiScan (v6.0) K253413 is a FDA 510(k) cleared radiology medical device. Manufacturer: Perspectum, Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k253934/ 2026-03-09 monthly 0.8 https://www.510kdatabase.net/og-image/k253934-momcozy-wearable-breast-pump-bp380-fda-510k.jpg K253934 - Momcozy Wearable Breast Pump (BP380, BP380-A, BP380-B, BP380-C, M5, M5-A, M5-B, M5-C) K253934 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shenzhen Root Innovation Technology Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k253960/ 2026-03-09 monthly 0.8 https://www.510kdatabase.net/og-image/k253960-medicell-mycosis-laser-mcml24004-fda-510k.jpg K253960 - Medicell Mycosis Laser (MCML24004) K253960 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medicell Healthcare Co.,LTD. Cleared Mar 2026. https://www.510kdatabase.net/k254032/ 2026-03-09 monthly 0.8 https://www.510kdatabase.net/og-image/k254032-qiastat-dx-gastrointestinal-panel-2-fda-510k.jpg K254032 - QIAstat-Dx Gastrointestinal Panel 2 K254032 is a FDA 510(k) cleared microbiology medical device. Manufacturer: QIAGEN GmbH. Cleared Mar 2026. https://www.510kdatabase.net/k260069/ 2026-03-09 monthly 0.8 https://www.510kdatabase.net/og-image/k260069-depuy-synthes-volt-proximal-tibia-35-fda-510k.jpg K260069 - DePuy Synthes VOLT™ Proximal Tibia 3.5 Plating System K260069 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes GmbH. Cleared Mar 2026. https://www.510kdatabase.net/k260355/ 2026-03-09 monthly 0.8 https://www.510kdatabase.net/og-image/k260355-webest-multi-drug-urine-cup-fda-510k.jpg K260355 - Webest Multi-Drug Urine Cup K260355 is a FDA 510(k) cleared toxicology medical device. Manufacturer: WEBEST Biotech,, LLC. Cleared Mar 2026. https://www.510kdatabase.net/k260405/ 2026-03-09 monthly 0.8 https://www.510kdatabase.net/og-image/k260405-fibertape-button-fda-510k.jpg K260405 - FiberTape Button K260405 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k253668/ 2026-03-08 monthly 0.8 https://www.510kdatabase.net/og-image/k253668-onera-sleepmap-sleepmap-fda-510k.jpg K253668 - Onera SleepMap (SLEEPMAP) K253668 is a FDA 510(k) cleared neurology medical device. Manufacturer: Onera B.V.. Cleared Mar 2026. https://www.510kdatabase.net/k251807/ 2026-03-06 monthly 0.8 https://www.510kdatabase.net/og-image/k251807-single-use-electrosurgical-hemostatic-fda-510k.jpg K251807 - Single Use Electrosurgical Hemostatic Forceps FD-410LR, FD-411UR, FD-412LR K251807 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Mar 2026. https://www.510kdatabase.net/k251818/ 2026-03-06 monthly 0.8 https://www.510kdatabase.net/og-image/k251818-bontree-plus-fda-510k.jpg K251818 - BONTREE PLUS K251818 is a FDA 510(k) cleared dental medical device. Manufacturer: Hudens Bio Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k252208/ 2026-03-06 monthly 0.8 https://www.510kdatabase.net/og-image/k252208-jford-speculum-sleeve-fda-510k.jpg K252208 - JFord Speculum Sleeve™ K252208 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ford Medtech, LLC. Cleared Mar 2026. https://www.510kdatabase.net/k253132/ 2026-03-06 monthly 0.8 https://www.510kdatabase.net/og-image/k253132-singleusestoneretrievalballoons-fda-510k.jpg K253132 - Single use stone retrieval balloons K253132 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Zhejiang Chuangxiang Medical Technology Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k253262/ 2026-03-06 monthly 0.8 https://www.510kdatabase.net/og-image/k253262-emeryglide-eg18008901-fda-510k.jpg K253262 - EmeryGlide™ (EG18008901) K253262 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nano4imaging GmbH. Cleared Mar 2026. https://www.510kdatabase.net/k253538/ 2026-03-06 monthly 0.8 https://www.510kdatabase.net/og-image/k253538-tekbrace-knotless-anchor-fda-510k.jpg K253538 - TeKBrace Knotless Anchor K253538 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Theramicro. Cleared Mar 2026. https://www.510kdatabase.net/k253551/ 2026-03-06 monthly 0.8 https://www.510kdatabase.net/og-image/k253551-velys-hip-navigation-fda-510k.jpg K253551 - VELYS™ Hip Navigation K253551 is a FDA 510(k) cleared radiology medical device. Manufacturer: Depuy Ireland UC. Cleared Mar 2026. https://www.510kdatabase.net/k253772/ 2026-03-06 monthly 0.8 https://www.510kdatabase.net/og-image/k253772-velocity-alpha-mr-high-speed-surgical-fda-510k.jpg K253772 - Velocity Alpha MR High Speed Surgical Drill System K253772 is a FDA 510(k) cleared neurology medical device. Manufacturer: Adeor Medical AG. Cleared Mar 2026. https://www.510kdatabase.net/k253951/ 2026-03-06 monthly 0.8 https://www.510kdatabase.net/og-image/k253951-holmium-laser-therapeutic-apparatus-hz-a-fda-510k.jpg K253951 - Holmium Laser Therapeutic Apparatus (HZ-A) K253951 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k253983/ 2026-03-06 monthly 0.8 https://www.510kdatabase.net/og-image/k253983-water-based-lubricant-fda-510k.jpg K253983 - Water-based lubricant K253983 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Guangzhou Haoyimai Trading Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k260013/ 2026-03-06 monthly 0.8 https://www.510kdatabase.net/og-image/k260013-cvac-image-processor-fda-510k.jpg K260013 - CVAC Image Processor K260013 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Calyxo, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k260166/ 2026-03-06 monthly 0.8 https://www.510kdatabase.net/og-image/k260166-bunkerhill-contrast-cac-fda-510k.jpg K260166 - Bunkerhill Contrast CAC K260166 is a FDA 510(k) cleared radiology medical device. Manufacturer: BunkerHill Health. Cleared Mar 2026. https://www.510kdatabase.net/k260167/ 2026-03-06 monthly 0.8 https://www.510kdatabase.net/og-image/k260167-bunkerhill-contrast-avc-fda-510k.jpg K260167 - Bunkerhill Contrast AVC K260167 is a FDA 510(k) cleared radiology medical device. Manufacturer: BunkerHill Health. Cleared Mar 2026. https://www.510kdatabase.net/k260361/ 2026-03-06 monthly 0.8 https://www.510kdatabase.net/og-image/k260361-treace-medical-concepts-tmc-screw-fda-510k.jpg K260361 - Treace Medical Concepts (TMC) Screw Fixation System K260361 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Treace Medical Concepts, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k251788/ 2026-03-05 monthly 0.8 https://www.510kdatabase.net/og-image/k251788-extension-tube-fda-510k.jpg K251788 - Extension tube K251788 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zhuhai DR Medical Instruments Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k251901/ 2026-03-05 monthly 0.8 https://www.510kdatabase.net/og-image/k251901-magnifico-open-100009900-fda-510k.jpg K251901 - Magnifico Open (100009900) K251901 is a FDA 510(k) cleared radiology medical device. Manufacturer: Esaote, S.P.A.. Cleared Mar 2026. https://www.510kdatabase.net/k252196/ 2026-03-05 monthly 0.8 https://www.510kdatabase.net/og-image/k252196-arthrex-fibulock-nail-system-fda-510k.jpg K252196 - Arthrex FibuLock Nail System K252196 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k252450/ 2026-03-05 monthly 0.8 https://www.510kdatabase.net/og-image/k252450-adhese-2-fda-510k.jpg K252450 - Adhese 2 K252450 is a FDA 510(k) cleared dental medical device. Manufacturer: Ivoclar Vivadent, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k252538/ 2026-03-05 monthly 0.8 https://www.510kdatabase.net/og-image/k252538-cephx3d-fda-510k.jpg K252538 - CEPHX3D K252538 is a FDA 510(k) cleared radiology medical device. Manufacturer: Orca Dental AI , Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k252779/ 2026-03-05 monthly 0.8 https://www.510kdatabase.net/og-image/k252779-yuwell-electronic-blood-pressure-fda-510k.jpg K252779 - YUWELL® Electronic Blood Pressure Monitor (YE630CR) K252779 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Jiangsu Yuyue Medical Equipment& Supply Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k253267/ 2026-03-05 monthly 0.8 https://www.510kdatabase.net/og-image/k253267-coris-system-fda-510k.jpg K253267 - CORIS System K253267 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Nanosonics Limited. Cleared Mar 2026. https://www.510kdatabase.net/k253442/ 2026-03-05 monthly 0.8 https://www.510kdatabase.net/og-image/k253442-earlipoint-assessment-fda-510k.jpg K253442 - EarliPoint Assessment K253442 is a FDA 510(k) cleared neurology medical device. Manufacturer: Earlitec Diagnostics. Cleared Mar 2026. https://www.510kdatabase.net/k253591/ 2026-03-05 monthly 0.8 https://www.510kdatabase.net/og-image/k253591-phantom-hindfoot-ttctc-nail-system-fda-510k.jpg K253591 - Phantom® Hindfoot TTC/TC Nail System K253591 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paragon 28, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k260169/ 2026-03-05 monthly 0.8 https://www.510kdatabase.net/og-image/k260169-av-cardiac-ct-fda-510k.jpg K260169 - AV Cardiac CT K260169 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Mar 2026. https://www.510kdatabase.net/k251434/ 2026-03-04 monthly 0.8 https://www.510kdatabase.net/og-image/k251434-healing-abutment-system-fda-510k.jpg K251434 - Healing Abutment System K251434 is a FDA 510(k) cleared dental medical device. Manufacturer: Osstem Implant Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k252025/ 2026-03-04 monthly 0.8 https://www.510kdatabase.net/og-image/k252025-active-intramedullary-aim-tibial-nail-fda-510k.jpg K252025 - Active Intramedullary (AIM) Tibial Nail System K252025 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Satori Orthopaedics, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k253493/ 2026-03-04 monthly 0.8 https://www.510kdatabase.net/og-image/k253493-dentis-sq-sl-axel-fixture-fda-510k.jpg K253493 - Dentis SQ-SL AXEL Fixture K253493 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentis Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k253565/ 2026-03-04 monthly 0.8 https://www.510kdatabase.net/og-image/k253565-suresmile-software-fda-510k.jpg K253565 - SureSmile Software K253565 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k253870/ 2026-03-04 monthly 0.8 https://www.510kdatabase.net/og-image/k253870-electric-wheelchair-mp148-fda-510k.jpg K253870 - Electric Wheelchair (MP148) K253870 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Suzhou Master Machinery Manufacturing Co.,Ltd. Cleared Mar 2026. https://www.510kdatabase.net/k253871/ 2026-03-04 monthly 0.8 https://www.510kdatabase.net/og-image/k253871-klr-lite-rcw-kl1000-fda-510k.jpg K253871 - Klär Lite (RCW-KL1000) K253871 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Radcliffe Watts, LLC. Cleared Mar 2026. https://www.510kdatabase.net/k253878/ 2026-03-04 monthly 0.8 https://www.510kdatabase.net/og-image/k253878-lustre-goglow-advanced-led-patches-fda-510k.jpg K253878 - LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001) K253878 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Kaiyan Medical Equipment Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k253896/ 2026-03-04 monthly 0.8 https://www.510kdatabase.net/og-image/k253896-tensems-device-guse01-fda-510k.jpg K253896 - TENS/EMS device (GUSE01) K253896 is a FDA 510(k) cleared neurology medical device. Manufacturer: Globalcare Medical Technology Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k253898/ 2026-03-04 monthly 0.8 https://www.510kdatabase.net/og-image/k253898-qt-scanner-2000-model-a-fda-510k.jpg K253898 - QT Scanner 2000 Model A K253898 is a FDA 510(k) cleared radiology medical device. Manufacturer: QT Imaging Holdings, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k254306/ 2026-03-04 monthly 0.8 https://www.510kdatabase.net/og-image/k254306-aevumed-fenix-suture-anchor-fda-510k.jpg K254306 - Aevumed FENIX Suture Anchor K254306 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aevumed, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k260015/ 2026-03-04 monthly 0.8 https://www.510kdatabase.net/og-image/k260015-anteris-thoracolumbar-plate-system-fda-510k.jpg K260015 - ANTERIS Thoracolumbar Plate System K260015 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SpineCraft. Cleared Mar 2026. https://www.510kdatabase.net/k260365/ 2026-03-04 monthly 0.8 https://www.510kdatabase.net/og-image/k260365-mammotome-prima-mr-dual-vacuum-fda-510k.jpg K260365 - Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System Control Module K260365 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Devicor Medical Products, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k260380/ 2026-03-04 monthly 0.8 https://www.510kdatabase.net/og-image/k260380-mendit-fda-510k.jpg K260380 - Mendit K260380 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Escala Medical, Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/den250012/ 2026-03-04 monthly 0.8 https://www.510kdatabase.net/og-image/den250012-lifevac-fda-510k.jpg DEN250012 - LifeVac DEN250012 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Lifevac, LLC. Cleared Mar 2026. https://www.510kdatabase.net/k251793/ 2026-03-03 monthly 0.8 https://www.510kdatabase.net/og-image/k251793-sota-cloud-smart-sensor-15-fda-510k.jpg K251793 - SOTA Cloud Smart Sensor (1.5) K251793 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sota Cloud Corp.. Cleared Mar 2026. https://www.510kdatabase.net/k251940/ 2026-03-03 monthly 0.8 https://www.510kdatabase.net/og-image/k251940-pathloc-lumbar-plate-system-fda-510k.jpg K251940 - PathLoc Lumbar Plate System K251940 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: L & K Biomed Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k252534/ 2026-03-03 monthly 0.8 https://www.510kdatabase.net/og-image/k252534-surgical-face-mask-ear-mount-fda-510k.jpg K252534 - Surgical Face Mask (Ear mount) K252534 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zhejiang Hangkang Medical Equipment Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k253818/ 2026-03-03 monthly 0.8 https://www.510kdatabase.net/og-image/k253818-annalise-enterprise-fda-510k.jpg K253818 - Annalise Enterprise K253818 is a FDA 510(k) cleared radiology medical device. Manufacturer: Harrison-AI Medical Pty, Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k253845/ 2026-03-03 monthly 0.8 https://www.510kdatabase.net/og-image/k253845-anti-snoring-mouthpiece-l08-bp-l08-pt-fda-510k.jpg K253845 - Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB) K253845 is a FDA 510(k) cleared dental medical device. Manufacturer: Ram.Shaw Pte. , Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k253874/ 2026-03-03 monthly 0.8 https://www.510kdatabase.net/og-image/k253874-led-therapy-light-cob1400-hp1800pro-fda-510k.jpg K253874 - LED Therapy Light (COB1400, HP1800PRO) K253874 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Hanhua Opto Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k253920/ 2026-03-03 monthly 0.8 https://www.510kdatabase.net/og-image/k253920-co2-laser-treatment-machine-cfr3m1-fda-510k.jpg K253920 - CO2 Laser Treatment Machine (CFR3M1) K253920 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Haidari?Beauty?Technology?(Beijing)?Co.,?, Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k254245/ 2026-03-03 monthly 0.8 https://www.510kdatabase.net/og-image/k254245-zafira-fda-510k.jpg K254245 - ZAFIRA® K254245 is a FDA 510(k) cleared dental medical device. Manufacturer: New Stetic, SA. Cleared Mar 2026. https://www.510kdatabase.net/k260010/ 2026-03-03 monthly 0.8 https://www.510kdatabase.net/og-image/k260010-tmini-miniature-robotic-system-fda-510k.jpg K260010 - TMINI® Miniature Robotic System K260010 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: THINK Surgical, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k260353/ 2026-03-03 monthly 0.8 https://www.510kdatabase.net/og-image/k260353-arthrex-humeral-plating-system-fda-510k.jpg K260353 - Arthrex Humeral Plating System (Anatomic Humeral Plate) and Cerclage Button K260353 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k260682/ 2026-03-03 monthly 0.8 https://www.510kdatabase.net/og-image/k260682-bond-pr-universal-adhesive-fda-510k.jpg K260682 - Bond-PR™ Universal Adhesive K260682 is a FDA 510(k) cleared dental medical device. Manufacturer: Premier Dental Products Company. Cleared Mar 2026. https://www.510kdatabase.net/k251777/ 2026-03-02 monthly 0.8 https://www.510kdatabase.net/og-image/k251777-mesi-mtablet-spiro-fda-510k.jpg K251777 - MESI mTABLET SPIRO K251777 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Mesi D.O.O.. Cleared Mar 2026. https://www.510kdatabase.net/k252487/ 2026-03-02 monthly 0.8 https://www.510kdatabase.net/og-image/k252487-powerseal-open-extended-jaw-sealer-and-fda-510k.jpg K252487 - POWERSEAL Open Extended Jaw Sealer and Divider, Double-Action (PS-0021EJDA) K252487 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Gyrus Acmi, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k252531/ 2026-03-02 monthly 0.8 https://www.510kdatabase.net/og-image/k252531-myosa-s1h-s1-s2-s3-s1m-s2m-fda-510k.jpg K252531 - Myosa (S1H, S1, S2, S3, S1M, S2M) K252531 is a FDA 510(k) cleared dental medical device. Manufacturer: Myofunctional Research Co.. Cleared Mar 2026. https://www.510kdatabase.net/k252632/ 2026-03-02 monthly 0.8 https://www.510kdatabase.net/og-image/k252632-microwave-ablation-device-fda-510k.jpg K252632 - Microwave Ablation Device K252632 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Nanjing Dewen Medical Technology Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k253380/ 2026-03-02 monthly 0.8 https://www.510kdatabase.net/og-image/k253380-flnt-base-and-flnt-temp-fda-510k.jpg K253380 - “FLNT Base” and “FLNT Temp” K253380 is a FDA 510(k) cleared dental medical device. Manufacturer: Liaoning Upcera Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k253593/ 2026-03-02 monthly 0.8 https://www.510kdatabase.net/og-image/k253593-clarius-ejection-fraction-ai-fda-510k.jpg K253593 - Clarius Ejection Fraction AI K253593 is a FDA 510(k) cleared radiology medical device. Manufacturer: Clarius Mobile Health Corp.. Cleared Mar 2026. https://www.510kdatabase.net/k253771/ 2026-03-02 monthly 0.8 https://www.510kdatabase.net/og-image/k253771-disposable-microwave-ablation-antenna-fda-510k.jpg K253771 - Disposable Microwave Ablation Antenna (DW-XR-II1, DW-XR-II3, DW-XR-II4, DW-XR-II14, DW-XR-II5, DW-XR-II6, DW-XR-II7, DW-XR-II8, DW-XR-II9, DW-XR-II10, DW-XR-II18, DW-XR-II19, DW-XR-II20, DW-XR-II21, DW-DG-II6, DW-DG-II7, DW-DG-II9, DW-DG-II10, DW-DG-II13) K253771 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Nanjing Devin Medical Technology Co., Ltd.. Cleared Mar 2026. https://www.510kdatabase.net/k253798/ 2026-03-02 monthly 0.8 https://www.510kdatabase.net/og-image/k253798-ultraprint-dental-hard-splint-uv-fda-510k.jpg K253798 - UltraPrint-Dental Hard Splint UV K253798 is a FDA 510(k) cleared dental medical device. Manufacturer: Guangzhou Heygears IMC., Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k254054/ 2026-03-02 monthly 0.8 https://www.510kdatabase.net/og-image/k254054-volt-ankle-trauma-2735-plating-system-fda-510k.jpg K254054 - VOLT™ Ankle Trauma 2.7/3.5 Plating System K254054 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes GmbH. Cleared Mar 2026. https://www.510kdatabase.net/k254229/ 2026-03-02 monthly 0.8 https://www.510kdatabase.net/og-image/k254229-arthrex-nano-fibertak-suture-anchor-fda-510k.jpg K254229 - Arthrex Nano FiberTak Suture Anchor K254229 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Mar 2026. https://www.510kdatabase.net/k260003/ 2026-03-02 monthly 0.8 https://www.510kdatabase.net/og-image/k260003-karl-storz-mediastinoscopes-and-fda-510k.jpg K260003 - KARL STORZ Mediastinoscopes and Instruments K260003 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Karl Storz SE & CO. KG. Cleared Mar 2026. https://www.510kdatabase.net/k251998/ 2026-02-27 monthly 0.8 https://www.510kdatabase.net/og-image/k251998-atellica-ch-diazo-total-bilirubin-dtbil-fda-510k.jpg K251998 - Atellica CH Diazo Total Bilirubin (D_TBil) K251998 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k252448/ 2026-02-27 monthly 0.8 https://www.510kdatabase.net/og-image/k252448-avita-pulse-oximeter-sp61-fda-510k.jpg K252448 - AViTA Pulse Oximeter (SP61) K252448 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Avita Corporation. Cleared Feb 2026. https://www.510kdatabase.net/k252714/ 2026-02-27 monthly 0.8 https://www.510kdatabase.net/og-image/k252714-c-lant-port-fda-510k.jpg K252714 - C-Lant Port K252714 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Vigor Medical Technologies , Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k253535/ 2026-02-27 monthly 0.8 https://www.510kdatabase.net/og-image/k253535-ligence-heart-fda-510k.jpg K253535 - Ligence Heart K253535 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ligence Uab. Cleared Feb 2026. https://www.510kdatabase.net/k253536/ 2026-02-27 monthly 0.8 https://www.510kdatabase.net/og-image/k253536-evala-nerve-stimulator-epnr002-fda-510k.jpg K253536 - Evala Nerve Stimulator (EPNR002) K253536 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Epineuron Technologies, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k253695/ 2026-02-27 monthly 0.8 https://www.510kdatabase.net/og-image/k253695-ligamend-fda-510k.jpg K253695 - LigaMend K253695 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Riverpoint Medical, LLC. Cleared Feb 2026. https://www.510kdatabase.net/k253778/ 2026-02-27 monthly 0.8 https://www.510kdatabase.net/og-image/k253778-allday-moisturizing-rinse-fda-510k.jpg K253778 - Allday Moisturizing Rinse K253778 is a FDA 510(k) cleared dental medical device. Manufacturer: Elevate Oral Care. Cleared Feb 2026. https://www.510kdatabase.net/k253797/ 2026-02-27 monthly 0.8 https://www.510kdatabase.net/og-image/k253797-one-stop-fda-510k.jpg K253797 - One-Stop K253797 is a FDA 510(k) cleared dental medical device. Manufacturer: Mediclus Co., Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k253828/ 2026-02-27 monthly 0.8 https://www.510kdatabase.net/og-image/k253828-medical-alexandrite-and-ndyag-laser-fda-510k.jpg K253828 - Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP) K253828 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Beijing HuaCheng Taike Technology Co., Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k253829/ 2026-02-27 monthly 0.8 https://www.510kdatabase.net/og-image/k253829-medical-ultra-pico-laser-treatment-fda-510k.jpg K253829 - Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532) K253829 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Beijing HuaCheng Taike Technology Co., Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k254249/ 2026-02-27 monthly 0.8 https://www.510kdatabase.net/og-image/k254249-hkt-anatomical-locking-trauma-system-fda-510k.jpg K254249 - HKT Anatomical Locking Trauma System K254249 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Hankil Tech Medical Co., Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k260292/ 2026-02-27 monthly 0.8 https://www.510kdatabase.net/og-image/k260292-hotwire-rf-guidewire-901xxx-fda-510k.jpg K260292 - HOTWIRE RF GUIDEWIRE (901XXX) K260292 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Atraverse Medical. Cleared Feb 2026. https://www.510kdatabase.net/k251700/ 2026-02-26 monthly 0.8 https://www.510kdatabase.net/og-image/k251700-ganymede-2cm-diameter-fg100300-fda-510k.jpg K251700 - Ganymede 2cm diameter (FG100300) K251700 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Speciality Fibres and Materials Limited. Cleared Feb 2026. https://www.510kdatabase.net/k251860/ 2026-02-26 monthly 0.8 https://www.510kdatabase.net/og-image/k251860-copioumed-aami-3-surgical-gown-fda-510k.jpg K251860 - Copioumed AAMI 3 Surgical Gown K251860 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Copioumed International, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k252166/ 2026-02-26 monthly 0.8 https://www.510kdatabase.net/og-image/k252166-rib-link-fixation-system-fda-510k.jpg K252166 - RIB LINK™ Fixation System K252166 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k253021/ 2026-02-26 monthly 0.8 https://www.510kdatabase.net/og-image/k253021-anne-maternal-fda-510k.jpg K253021 - ANNE Maternal K253021 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Sibel Health, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k253328/ 2026-02-26 monthly 0.8 https://www.510kdatabase.net/og-image/k253328-gmk-3d-metal-tibial-tray-extension-fda-510k.jpg K253328 - GMK 3D Metal Tibial Tray Extension K253328 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Feb 2026. https://www.510kdatabase.net/k253578/ 2026-02-26 monthly 0.8 https://www.510kdatabase.net/og-image/k253578-briefcase-triage-care-multi-triage-ct-fda-510k.jpg K253578 - BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax K253578 is a FDA 510(k) cleared radiology medical device. Manufacturer: Aidoc Medical , Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k253641/ 2026-02-26 monthly 0.8 https://www.510kdatabase.net/og-image/k253641-owl-night-guard-fda-510k.jpg K253641 - Owl Night Guard K253641 is a FDA 510(k) cleared dental medical device. Manufacturer: Owl Dental Lab, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k253764/ 2026-02-26 monthly 0.8 https://www.510kdatabase.net/og-image/k253764-enos-software-guided-external-fixation-fda-510k.jpg K253764 - ENOS Software Guided External Fixation System K253764 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Disior, Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k253791/ 2026-02-26 monthly 0.8 https://www.510kdatabase.net/og-image/k253791-purevue-quick-connect-cannula-system-fda-510k.jpg K253791 - PUREVUE™ Quick Connect Cannula System Tray K253791 is a FDA 510(k) cleared general hospital medical device. Manufacturer: DePuy Mitek, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k254017/ 2026-02-26 monthly 0.8 https://www.510kdatabase.net/og-image/k254017-swingo-3d-lumbar-cage-system-fda-510k.jpg K254017 - SWINGO-3D Lumbar Cage System K254017 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Implanet. Cleared Feb 2026. https://www.510kdatabase.net/k254182/ 2026-02-26 monthly 0.8 https://www.510kdatabase.net/og-image/k254182-aster-fda-510k.jpg K254182 - Aster K254182 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonic Co., Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k254242/ 2026-02-26 monthly 0.8 https://www.510kdatabase.net/og-image/k254242-karl-storz-icg-imaging-system-with-fda-510k.jpg K254242 - KARL STORZ ICG Imaging System with RUBINA® Lens K254242 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Karl Storz SE & CO. KG. Cleared Feb 2026. https://www.510kdatabase.net/k254251/ 2026-02-26 monthly 0.8 https://www.510kdatabase.net/og-image/k254251-innovexview-gc146-17-gc150-20-gc155-23-fda-510k.jpg K254251 - InnovexView (GC146-17, GC150-20, GC155-23) K254251 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shanghai AnQing Medical Instrument Co., Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k254271/ 2026-02-26 monthly 0.8 https://www.510kdatabase.net/og-image/k254271-capri-fda-510k.jpg K254271 - CAPRI K254271 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: ORO Co., Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k260254/ 2026-02-26 monthly 0.8 https://www.510kdatabase.net/og-image/k260254-enbio-pro-fda-510k.jpg K260254 - Enbio PRO K260254 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Enbio Group AG. Cleared Feb 2026. https://www.510kdatabase.net/k251687/ 2026-02-25 monthly 0.8 https://www.510kdatabase.net/og-image/k251687-konig-bell-circumcision-clamp-fda-510k.jpg K251687 - Konig Bell Circumcision Clamp K251687 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Medline Industries, LP. Cleared Feb 2026. https://www.510kdatabase.net/k251724/ 2026-02-25 monthly 0.8 https://www.510kdatabase.net/og-image/k251724-remi-impression-material-fda-510k.jpg K251724 - Remi Impression Material K251724 is a FDA 510(k) cleared dental medical device. Manufacturer: Grindguard, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k253472/ 2026-02-25 monthly 0.8 https://www.510kdatabase.net/og-image/k253472-firefly-pedicle-screw-navigation-guide-fda-510k.jpg K253472 - FIREFLY® Pedicle Screw Navigation Guide K253472 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Mighty Oak Medical. Cleared Feb 2026. https://www.510kdatabase.net/k253559/ 2026-02-25 monthly 0.8 https://www.510kdatabase.net/og-image/k253559-ventana-a-anterior-lumbar-interbody-fda-510k.jpg K253559 - Ventana™ A Anterior Lumbar Interbody System K253559 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinal Elements, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k253789/ 2026-02-25 monthly 0.8 https://www.510kdatabase.net/og-image/k253789-electric-wheelchair-fda-510k.jpg K253789 - Electric wheelchair K253789 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zhejiang Yikang Medical Technology Co., Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k253996/ 2026-02-25 monthly 0.8 https://www.510kdatabase.net/og-image/k253996-bd-surgiphor-antimicrobial-irrigation-fda-510k.jpg K253996 - BD Surgiphor™ Antimicrobial Irrigation System (910110) K253996 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Becton, Dickinson and Company (BD). Cleared Feb 2026. https://www.510kdatabase.net/k260222/ 2026-02-25 monthly 0.8 https://www.510kdatabase.net/og-image/k260222-mako-total-knee-application-fda-510k.jpg K260222 - Mako Total Knee Application K260222 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Mako Surgical Corp.. Cleared Feb 2026. https://www.510kdatabase.net/k251678/ 2026-02-24 monthly 0.8 https://www.510kdatabase.net/og-image/k251678-swift-ray-1-fda-510k.jpg K251678 - Swift Ray 1 K251678 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Swift Medical, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k252599/ 2026-02-24 monthly 0.8 https://www.510kdatabase.net/og-image/k252599-diode-laser-therapy-systems-wla-02-fda-510k.jpg K252599 - Diode Laser Therapy Systems (WLA-02) K252599 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wingderm Electro-Optics , Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k253186/ 2026-02-24 monthly 0.8 https://www.510kdatabase.net/og-image/k253186-hemosphere-nano-monitor-hsnano1-fda-510k.jpg K253186 - HemoSphere Nano Monitor (HSNANO1) K253186 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Feb 2026. https://www.510kdatabase.net/k253707/ 2026-02-24 monthly 0.8 https://www.510kdatabase.net/og-image/k253707-electric-wheelchair-w1w3-fda-510k.jpg K253707 - Electric wheelchair (W1,W3) K253707 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Shenzhen Zhimahuaerkai Technology Co., Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k253714/ 2026-02-24 monthly 0.8 https://www.510kdatabase.net/og-image/k253714-intrasight-plus-fda-510k.jpg K253714 - IntraSight Plus K253714 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Philips Image Guided Therapy Corporation. Cleared Feb 2026. https://www.510kdatabase.net/k253978/ 2026-02-24 monthly 0.8 https://www.510kdatabase.net/og-image/k253978-universal-seal-5-12-mm-fda-510k.jpg K253978 - Universal Seal (5-12 mm) K253978 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k254055/ 2026-02-24 monthly 0.8 https://www.510kdatabase.net/og-image/k254055-ossiofiber-suture-anchor-fda-510k.jpg K254055 - OSSIOfiber® Suture Anchor K254055 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OSSIO , Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k254247/ 2026-02-24 monthly 0.8 https://www.510kdatabase.net/og-image/k254247-osteomni-spinal-fixation-system-fda-510k.jpg K254247 - OSTEOMNI SPINAL FIXATION SYSTEM K254247 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OSTEOMNI, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k254267/ 2026-02-24 monthly 0.8 https://www.510kdatabase.net/og-image/k254267-nanopress-760a-bt-760a-bt-fda-510k.jpg K254267 - NanoPress 760A-BT (760A-BT) K254267 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Mego Afek , Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k260217/ 2026-02-24 monthly 0.8 https://www.510kdatabase.net/og-image/k260217-ai-platform-22-aip002-fda-510k.jpg K260217 - AI Platform 2.2 (AIP002) K260217 is a FDA 510(k) cleared radiology medical device. Manufacturer: Exo Imaging. Cleared Feb 2026. https://www.510kdatabase.net/k260287/ 2026-02-24 monthly 0.8 https://www.510kdatabase.net/og-image/k260287-sp-electrocautery-device-sp20-fda-510k.jpg K260287 - SP Electrocautery Device (SP20) K260287 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Single Pass, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k260377/ 2026-02-24 monthly 0.8 https://www.510kdatabase.net/og-image/k260377-xsense-cryoablation-system-with-fda-510k.jpg K260377 - XSense Cryoablation System with CryoProbes K260377 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: IceCure Medical , Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k251587/ 2026-02-23 monthly 0.8 https://www.510kdatabase.net/og-image/k251587-vita-vmlc-primer-fda-510k.jpg K251587 - VITA VMLC Primer K251587 is a FDA 510(k) cleared dental medical device. Manufacturer: Vita Zahnfabrik H. Rauter GmbH & Co. Kg.. Cleared Feb 2026. https://www.510kdatabase.net/k251661/ 2026-02-23 monthly 0.8 https://www.510kdatabase.net/og-image/k251661-mariana-minerva-fda-510k.jpg K251661 - Mariana Minerva K251661 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Resmed Pty , Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k251864/ 2026-02-23 monthly 0.8 https://www.510kdatabase.net/og-image/k251864-rubber-utility-catheter-fda-510k.jpg K251864 - Rubber Utility Catheter K251864 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k252795/ 2026-02-23 monthly 0.8 https://www.510kdatabase.net/og-image/k252795-zenicore-automatic-biopsy-instrument-fda-510k.jpg K252795 - ZeniCore™ Automatic Biopsy Instrument (863212100 / ZeniCore Automatic Biopsy Device 12ga x 10cm with Coaxial Introducer Kit) K252795 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Argon Medical Devices, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k253068/ 2026-02-23 monthly 0.8 https://www.510kdatabase.net/og-image/k253068-profoject-insulin-syringes-fda-510k.jpg K253068 - Profoject™ Insulin Syringes K253068 is a FDA 510(k) cleared general hospital medical device. Manufacturer: CMT Health PTE., Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k253169/ 2026-02-23 monthly 0.8 https://www.510kdatabase.net/og-image/k253169-duet-spinal-fixation-system-fda-510k.jpg K253169 - Duet™ Spinal Fixation System K253169 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Box Spine, LLC. Cleared Feb 2026. https://www.510kdatabase.net/k253228/ 2026-02-23 monthly 0.8 https://www.510kdatabase.net/og-image/k253228-yuwell-electronic-blood-pressure-fda-510k.jpg K253228 - YUWELL® Electronic Blood Pressure Monitor (YE650AR) K253228 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Jiangsu Yuyue Medical Equipment& Supply Co., Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k253244/ 2026-02-23 monthly 0.8 https://www.510kdatabase.net/og-image/k253244-airray-mini-80a-airray-mini-90a-airray-fda-510k.jpg K253244 - AirRay-mini 80A, AirRay-mini 90A, AirRay-mini 80F, AirRay-mini 90F (AirRay-mini) K253244 is a FDA 510(k) cleared radiology medical device. Manufacturer: Poskom Co., Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k253486/ 2026-02-23 monthly 0.8 https://www.510kdatabase.net/og-image/k253486-skia-head-model-skia-st00-fda-510k.jpg K253486 - SKIA-Head (Model: SKIA-ST00) K253486 is a FDA 510(k) cleared radiology medical device. Manufacturer: Skia, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k253531/ 2026-02-23 monthly 0.8 https://www.510kdatabase.net/og-image/k253531-alexis-lighted-wound-protector-fda-510k.jpg K253531 - Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402) K253531 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Applied Medical Resources Corporation. Cleared Feb 2026. https://www.510kdatabase.net/k253583/ 2026-02-23 monthly 0.8 https://www.510kdatabase.net/og-image/k253583-lux-expandable-lumbar-interbody-system-fda-510k.jpg K253583 - LUX Expandable Lumbar Interbody System K253583 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Xenix Medical. Cleared Feb 2026. https://www.510kdatabase.net/k253631/ 2026-02-23 monthly 0.8 https://www.510kdatabase.net/og-image/k253631-mobility-scooter-cl-q3-cl-q4-fda-510k.jpg K253631 - Mobility Scooter (CL-Q3, CL-Q4) K253631 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zhejiang Wei Ling New Energy Technology Co., Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k253648/ 2026-02-23 monthly 0.8 https://www.510kdatabase.net/og-image/k253648-ingenia-ingenia-cx-ingenia-elition-sx-fda-510k.jpg K253648 - Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades K253648 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Feb 2026. https://www.510kdatabase.net/k253666/ 2026-02-23 monthly 0.8 https://www.510kdatabase.net/og-image/k253666-ipl-hair-removal-device-models-t31a-t32a-fda-510k.jpg K253666 - IPL Hair Removal Device (Models: T31A, T32A) K253666 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Mlay Intelligent Technology Co., Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k260043/ 2026-02-23 monthly 0.8 https://www.510kdatabase.net/og-image/k260043-smart-reactors-camouflage-coated-fda-510k.jpg K260043 - Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C) K260043 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Smart Reactors. Cleared Feb 2026. https://www.510kdatabase.net/k260265/ 2026-02-23 monthly 0.8 https://www.510kdatabase.net/og-image/k260265-magnetom-flowace-fda-510k.jpg K260265 - MAGNETOM Flow.Ace K260265 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Shenzhen Magnetic Resonance , Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k253646/ 2026-02-22 monthly 0.8 https://www.510kdatabase.net/og-image/k253646-single-use-distal-cover-maj-2315-maj-fda-510k.jpg K253646 - Single Use Distal Cover MAJ-2315 (MAJ-2315) K253646 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Feb 2026. https://www.510kdatabase.net/k251692/ 2026-02-21 monthly 0.8 https://www.510kdatabase.net/og-image/k251692-advanced-tissue-resection-device-fda-510k.jpg K251692 - Advanced Tissue Resection Device K251692 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Micro-Tech (Nanjing) Co., Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k251653/ 2026-02-20 monthly 0.8 https://www.510kdatabase.net/og-image/k251653-spry-tms-therapy-system-0550-fda-510k.jpg K251653 - SPRY TMS Therapy System (0550) K251653 is a FDA 510(k) cleared neurology medical device. Manufacturer: Soterix Medical, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k251890/ 2026-02-20 monthly 0.8 https://www.510kdatabase.net/og-image/k251890-disposable-ureteral-stents-fda-510k.jpg K251890 - Disposable Ureteral Stents K251890 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Zhejiang Chuangxiang Medical Technology Co., Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k252500/ 2026-02-20 monthly 0.8 https://www.510kdatabase.net/og-image/k252500-cara-system-fda-510k.jpg K252500 - CARA System K252500 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cara Medical, Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k252619/ 2026-02-20 monthly 0.8 https://www.510kdatabase.net/og-image/k252619-qscheck-uisacr-fda-510k.jpg K252619 - QSCHECK UISACR K252619 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Qstag, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k252672/ 2026-02-20 monthly 0.8 https://www.510kdatabase.net/og-image/k252672-casebio-culture-whsa-cmh5-fda-510k.jpg K252672 - CaseBio™ Culture w/HSA (CMH5) K252672 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Casebioscience, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k252972/ 2026-02-20 monthly 0.8 https://www.510kdatabase.net/og-image/k252972-carto-3-ep-navigation-system-v84-fda-510k.jpg K252972 - CARTO™ 3 EP Navigation System V8.4 K252972 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biosense Webster, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k252989/ 2026-02-20 monthly 0.8 https://www.510kdatabase.net/og-image/k252989-point-kinguide-agile-hybrid-navigation-fda-510k.jpg K252989 - “POINT” Kinguide Agile Hybrid Navigation System K252989 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Point Robotics MedTech, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k253445/ 2026-02-20 monthly 0.8 https://www.510kdatabase.net/og-image/k253445-bd-surgiphor-1000-ml-antimicrobial-fda-510k.jpg K253445 - BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120) K253445 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bd. Cleared Feb 2026. https://www.510kdatabase.net/k253605/ 2026-02-20 monthly 0.8 https://www.510kdatabase.net/og-image/k253605-safety-heel-lancet-fda-510k.jpg K253605 - Safety Heel Lancet K253605 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ningbo Medsun Medical Co., Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k253653/ 2026-02-20 monthly 0.8 https://www.510kdatabase.net/og-image/k253653-xpert-hemorrhagic-fever-fda-510k.jpg K253653 - Xpert Hemorrhagic Fever K253653 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Cepheid. Cleared Feb 2026. https://www.510kdatabase.net/k253660/ 2026-02-20 monthly 0.8 https://www.510kdatabase.net/og-image/k253660-kls-martin-pure-pectus-system-fda-510k.jpg K253660 - KLS Martin Pure Pectus System K253660 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: KLS-Martin L.P.. Cleared Feb 2026. https://www.510kdatabase.net/k253683/ 2026-02-20 monthly 0.8 https://www.510kdatabase.net/og-image/k253683-faq-led-panel-fda-510k.jpg K253683 - FAQ™ (LED Panel) K253683 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Foreo, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k254162/ 2026-02-20 monthly 0.8 https://www.510kdatabase.net/og-image/k254162-kls-martin-ixos-system-fda-510k.jpg K254162 - KLS Martin Ixos System K254162 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: KLS-Martin L.P.. Cleared Feb 2026. https://www.510kdatabase.net/k260181/ 2026-02-20 monthly 0.8 https://www.510kdatabase.net/og-image/k260181-lf-process-indicator-tape-for-steam-fda-510k.jpg K260181 - LF Process Indicator Tape for Steam Sterilization K260181 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Intertape Polymer Group. Cleared Feb 2026. https://www.510kdatabase.net/k251903/ 2026-02-19 monthly 0.8 https://www.510kdatabase.net/og-image/k251903-erchonia-dpn-laser-model-evrl-fda-510k.jpg K251903 - Erchonia DPN Laser (Model# EVRL) K251903 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Erchonia Corporation. Cleared Feb 2026. https://www.510kdatabase.net/k252002/ 2026-02-19 monthly 0.8 https://www.510kdatabase.net/og-image/k252002-monaco-rtp-system-63-fda-510k.jpg K252002 - Monaco RTP System (6.3) K252002 is a FDA 510(k) cleared radiology medical device. Manufacturer: Elekta Solutions AB. Cleared Feb 2026. https://www.510kdatabase.net/k252597/ 2026-02-19 monthly 0.8 https://www.510kdatabase.net/og-image/k252597-valence-robotic-navigation-system-fda-510k.jpg K252597 - Valence Robotic Navigation System K252597 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k252733/ 2026-02-19 monthly 0.8 https://www.510kdatabase.net/og-image/k252733-atlas-expandable-osteotomy-wedge-system-fda-510k.jpg K252733 - ATLAS™ Expandable Osteotomy Wedge System K252733 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: MiRus, LLC. Cleared Feb 2026. https://www.510kdatabase.net/k252814/ 2026-02-19 monthly 0.8 https://www.510kdatabase.net/og-image/k252814-profoject-low-dead-space-syringe-fda-510k.jpg K252814 - Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syringe K252814 is a FDA 510(k) cleared general hospital medical device. Manufacturer: CMT Health PTE., Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k253002/ 2026-02-19 monthly 0.8 https://www.510kdatabase.net/og-image/k253002-skinstylus-sterilock-microsystem-fda-510k.jpg K253002 - SkinStylus SteriLock MicroSystem (MP1209SL) K253002 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Esthetic Medical, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k253203/ 2026-02-19 monthly 0.8 https://www.510kdatabase.net/og-image/k253203-retrograde-coronary-sinus-perfusion-fda-510k.jpg K253203 - Retrograde Coronary Sinus Perfusion Cannulae K253203 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k253398/ 2026-02-19 monthly 0.8 https://www.510kdatabase.net/og-image/k253398-disposable-surgical-mask-non-sterile-fda-510k.jpg K253398 - Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) K253398 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Efofex, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k253612/ 2026-02-19 monthly 0.8 https://www.510kdatabase.net/og-image/k253612-acclarent-aera-eustachian-tube-balloon-fda-510k.jpg K253612 - Acclarent AERA Eustachian Tube Balloon Dilation System K253612 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Acclarent, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k253623/ 2026-02-19 monthly 0.8 https://www.510kdatabase.net/og-image/k253623-spine-guidance-54-software-fda-510k.jpg K253623 - Spine Guidance 5.4 Software K253623 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Leibinger GmbH & Co KG. Cleared Feb 2026. https://www.510kdatabase.net/k253687/ 2026-02-19 monthly 0.8 https://www.510kdatabase.net/og-image/k253687-access-anti-hbc-total-fda-510k.jpg K253687 - Access anti-HBc Total K253687 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k254018/ 2026-02-19 monthly 0.8 https://www.510kdatabase.net/og-image/k254018-portable-dental-x-ray-device-gt-1-fda-510k.jpg K254018 - Portable Dental X-ray Device (GT-1) K254018 is a FDA 510(k) cleared radiology medical device. Manufacturer: Guilin Refine Medical Instrument Co., Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k254148/ 2026-02-19 monthly 0.8 https://www.510kdatabase.net/og-image/k254148-verticale-gps-instruments-fda-510k.jpg K254148 - VERTICALE GPS Instruments K254148 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Silony Medical GmbH. Cleared Feb 2026. https://www.510kdatabase.net/k254188/ 2026-02-19 monthly 0.8 https://www.510kdatabase.net/og-image/k254188-meniscus-versaflex-fda-510k.jpg K254188 - Meniscus Versaflex K254188 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: GM Dos Reis Industria e Comercio Ltda.. Cleared Feb 2026. https://www.510kdatabase.net/k260163/ 2026-02-19 monthly 0.8 https://www.510kdatabase.net/og-image/k260163-aust-csp-introducer-fda-510k.jpg K260163 - AuST CSP Introducer K260163 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: CenterPoint Systems, LLC. Cleared Feb 2026. https://www.510kdatabase.net/k260205/ 2026-02-19 monthly 0.8 https://www.510kdatabase.net/og-image/k260205-as-software-version-asera-fda-510k.jpg K260205 - AS Software Version Asera K260205 is a FDA 510(k) cleared radiology medical device. Manufacturer: AS Software, LLC. Cleared Feb 2026. https://www.510kdatabase.net/k260218/ 2026-02-19 monthly 0.8 https://www.510kdatabase.net/og-image/k260218-lacertamatrix-fda-510k.jpg K260218 - LacertaMatrix K260218 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lacerta Life Sciences. Cleared Feb 2026. https://www.510kdatabase.net/k260308/ 2026-02-19 monthly 0.8 https://www.510kdatabase.net/og-image/k260308-truefit-bolus-fda-510k.jpg K260308 - TrueFit Bolus K260308 is a FDA 510(k) cleared radiology medical device. Manufacturer: Adaptiiv Medical Technologies, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k252098/ 2026-02-18 monthly 0.8 https://www.510kdatabase.net/og-image/k252098-pa3x-detachable-safety-sleeve-syringe-fda-510k.jpg K252098 - PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED) K252098 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Methyl Co., Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k252197/ 2026-02-18 monthly 0.8 https://www.510kdatabase.net/og-image/k252197-nobel-biocare-s-series-implants-fda-510k.jpg K252197 - Nobel Biocare S Series Implants K252197 is a FDA 510(k) cleared dental medical device. Manufacturer: Nobel Biocare AB. Cleared Feb 2026. https://www.510kdatabase.net/k252561/ 2026-02-18 monthly 0.8 https://www.510kdatabase.net/og-image/k252561-btl-754ff-fda-510k.jpg K252561 - BTL-754FF K252561 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: BTL Industries, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k253539/ 2026-02-18 monthly 0.8 https://www.510kdatabase.net/og-image/k253539-alere-nt-probnp-for-alinity-i-fda-510k.jpg K253539 - Alere NT-proBNP for Alinity i K253539 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Axis-Shield Diagnostics, Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k253637/ 2026-02-18 monthly 0.8 https://www.510kdatabase.net/og-image/k253637-triathlon-total-knee-system-triathlon-fda-510k.jpg K253637 - Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing Insert K253637 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp., Dba Stryker Orthopaedics. Cleared Feb 2026. https://www.510kdatabase.net/k253643/ 2026-02-18 monthly 0.8 https://www.510kdatabase.net/og-image/k253643-mobility-scooter-s3-fda-510k.jpg K253643 - Mobility Scooter (S3) K253643 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Shenzhen Zhimahuaerkai Technology Co., Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k260185/ 2026-02-18 monthly 0.8 https://www.510kdatabase.net/og-image/k260185-1688-4k-camera-system-with-advanced-fda-510k.jpg K260185 - 1688 4K Camera System with Advanced Imaging Modality K260185 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker Endoscopy. Cleared Feb 2026. https://www.510kdatabase.net/k250550/ 2026-02-17 monthly 0.8 https://www.510kdatabase.net/og-image/k250550-fujifilm-endoscope-model-eg-s100xt-and-fda-510k.jpg K250550 - FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit K250550 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fujifilm Corporation. Cleared Feb 2026. https://www.510kdatabase.net/k251680/ 2026-02-17 monthly 0.8 https://www.510kdatabase.net/og-image/k251680-biosteon-screw-fda-510k.jpg K251680 - Biosteon® Screw K251680 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biocomposites, Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k252805/ 2026-02-17 monthly 0.8 https://www.510kdatabase.net/og-image/k252805-yuwell-finger-pulse-oximeter-yx105-fda-510k.jpg K252805 - YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) K252805 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Jiangsu Yuyue Medical Equipment& Supply Co., Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k253524/ 2026-02-17 monthly 0.8 https://www.510kdatabase.net/og-image/k253524-adaptosfuse-bone-graft-fda-510k.jpg K253524 - Adaptos®Fuse Bone Graft K253524 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomendex OY. Cleared Feb 2026. https://www.510kdatabase.net/k253599/ 2026-02-17 monthly 0.8 https://www.510kdatabase.net/og-image/k253599-electric-wheelchair-w-a807-w-a807l-fda-510k.jpg K253599 - Electric Wheelchair (W-A807, W-A807L) K253599 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Ningbo Shenyu Medical Equipment Co.,Ltd. Cleared Feb 2026. https://www.510kdatabase.net/k254089/ 2026-02-17 monthly 0.8 https://www.510kdatabase.net/og-image/k254089-iops-visionary-system-mc-3-fda-510k.jpg K254089 - IOPS Visionary System (MC-3) K254089 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Centerline Biomedical, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k260149/ 2026-02-17 monthly 0.8 https://www.510kdatabase.net/og-image/k260149-versus-catheter-vs110-9nb-fda-510k.jpg K260149 - Versus™ Catheter (VS110-9NB) K260149 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Liquet Medical, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k243854/ 2026-02-13 monthly 0.8 https://www.510kdatabase.net/og-image/k243854-contour-light-cl-100-fda-510k.jpg K243854 - Contour Light (CL-100) K243854 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Contour Research, LLC. Cleared Feb 2026. https://www.510kdatabase.net/k250233/ 2026-02-13 monthly 0.8 https://www.510kdatabase.net/og-image/k250233-preemptiveai-clinical-sdk-fda-510k.jpg K250233 - PreemptiveAI Clinical SDK K250233 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Measure Labs, Inc. (Dba Preemptiveai, Inc.). Cleared Feb 2026. https://www.510kdatabase.net/k251581/ 2026-02-13 monthly 0.8 https://www.510kdatabase.net/og-image/k251581-wearable-ambulatory-blood-pressure-fda-510k.jpg K251581 - Wearable Ambulatory Blood Pressure Monitor (WBP-02A) K251581 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Hingmed Medical Instrument Co., Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k251619/ 2026-02-13 monthly 0.8 https://www.510kdatabase.net/og-image/k251619-babyleo-tn500-fda-510k.jpg K251619 - Babyleo TN500 K251619 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Dr?gerwerk AG & Co KGaA. Cleared Feb 2026. https://www.510kdatabase.net/k251742/ 2026-02-13 monthly 0.8 https://www.510kdatabase.net/og-image/k251742-velo-respiratory-test-fda-510k.jpg K251742 - VELO Respiratory Test K251742 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Lex Diagnostics Limited. Cleared Feb 2026. https://www.510kdatabase.net/k251802/ 2026-02-13 monthly 0.8 https://www.510kdatabase.net/og-image/k251802-star-rf-ablation-system-fda-510k.jpg K251802 - STAR RF Ablation System K251802 is a FDA 510(k) cleared neurology medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k251852/ 2026-02-13 monthly 0.8 https://www.510kdatabase.net/og-image/k251852-ccell-in-vivo-with-drop-in-robo-cn100-fda-510k.jpg K251852 - cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200) K251852 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: VPIX Medical, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k251928/ 2026-02-13 monthly 0.8 https://www.510kdatabase.net/og-image/k251928-coolcryo-cryoapplicator-for-cardiac-fda-510k.jpg K251928 - CoolCryo - Cryoapplicator for cardiac cryoablation (CC01-01) K251928 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medinice S.A.. Cleared Feb 2026. https://www.510kdatabase.net/k252400/ 2026-02-13 monthly 0.8 https://www.510kdatabase.net/og-image/k252400-endomina-ezfuse-system-fda-510k.jpg K252400 - Endomina EZFuse system K252400 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Endo Tools Therapeutics S.A.. Cleared Feb 2026. https://www.510kdatabase.net/k252420/ 2026-02-13 monthly 0.8 https://www.510kdatabase.net/og-image/k252420-wearable-breast-pump-model-w12-fda-510k.jpg K252420 - Wearable Breast Pump (Model W12) K252420 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shenzhen TPH Technology Co., Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k252422/ 2026-02-13 monthly 0.8 https://www.510kdatabase.net/og-image/k252422-wearable-breast-pump-model-w2-fda-510k.jpg K252422 - Wearable Breast Pump (Model W2) K252422 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shenzhen TPH Technology Co., Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k252512/ 2026-02-13 monthly 0.8 https://www.510kdatabase.net/og-image/k252512-armada-14-nc-pta-catheter-fda-510k.jpg K252512 - Armada™ 14 NC PTA Catheter K252512 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared Feb 2026. https://www.510kdatabase.net/k252565/ 2026-02-13 monthly 0.8 https://www.510kdatabase.net/og-image/k252565-preop-v3-fda-510k.jpg K252565 - PreOp v3 K252565 is a FDA 510(k) cleared neurology medical device. Manufacturer: Clouds of Care. Cleared Feb 2026. https://www.510kdatabase.net/k252685/ 2026-02-13 monthly 0.8 https://www.510kdatabase.net/og-image/k252685-arm-type-fully-automatic-digital-blood-fda-510k.jpg K252685 - Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, DBP-63D2L, DBP-63D2L-P, DBP-61D9L,DBP-61D9L-P, DBP-63D9L, DBP-63D9L-P, DBP-62F4L, DBP-62F4B, DBP-61F4,DBP-61F4L, DBP-61F4-P, DBP-61F4L-P, DBP-62F4L-P, DBP-62F4B-P) K252685 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Joytech Healthcare Co. , Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k252891/ 2026-02-13 monthly 0.8 https://www.510kdatabase.net/og-image/k252891-medrad-mrxperion-mr-injection-system-fda-510k.jpg K252891 - MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit K252891 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bayer Medical Care, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k253089/ 2026-02-13 monthly 0.8 https://www.510kdatabase.net/og-image/k253089-nibp-cuff-bcs-112-bcs-212-bcs-312-bcs-fda-510k.jpg K253089 - NIBP Cuff (BCS-112, BCS-212, BCS-312, BCS-412, BCS-512, BCS-612, BCS-712, BCS-122, BCS-222, BCS-322, BCS-422, BCS-522, BCS-622, BCS-722, BCD-112, BCD-212, BCD-312, BCD-412, BCD-512, BCD-612, BCD-712, BCD-122, BCD-222, BCD-322, BCD-422, BCD-522, BCD-622, BCD-722) K253089 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Best Electronics Co., Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k253092/ 2026-02-13 monthly 0.8 https://www.510kdatabase.net/og-image/k253092-argos-infinity-rev-10-fda-510k.jpg K253092 - Argos Infinity (Rev. 1.0) K253092 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Retia Medical Systems, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k253096/ 2026-02-13 monthly 0.8 https://www.510kdatabase.net/og-image/k253096-chartis-precision-catheter-fda-510k.jpg K253096 - Chartis Precision Catheter K253096 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Pulmonx Corporation. Cleared Feb 2026. https://www.510kdatabase.net/k253133/ 2026-02-13 monthly 0.8 https://www.510kdatabase.net/og-image/k253133-wrist-blood-pressure-monitor-bpm-w1vl-fda-510k.jpg K253133 - Wrist Blood Pressure Monitor (BPM-W1VL) K253133 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Imdk Medical Technology Co., Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k253149/ 2026-02-13 monthly 0.8 https://www.510kdatabase.net/og-image/k253149-motion-inbra-ym-8801-wearable-breast-fda-510k.jpg K253149 - Motion InBra (YM-8801) wearable breast pump K253149 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Medela, LLC. Cleared Feb 2026. https://www.510kdatabase.net/k253564/ 2026-02-13 monthly 0.8 https://www.510kdatabase.net/og-image/k253564-umi-panvivo-umi-panvivo-fda-510k.jpg K253564 - uMI Panvivo (uMI Panvivo) K253564 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k254052/ 2026-02-13 monthly 0.8 https://www.510kdatabase.net/og-image/k254052-dailies-total1-fda-510k.jpg K254052 - DAILIES TOTAL1® K254052 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Alcon Laboratories, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k254105/ 2026-02-13 monthly 0.8 https://www.510kdatabase.net/og-image/k254105-hive-standalone-cervical-system-and-fda-510k.jpg K254105 - Hive™ Standalone Cervical System and Hive™ C Interbody System K254105 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: NanoHive Medical, LLC. Cleared Feb 2026. https://www.510kdatabase.net/k260130/ 2026-02-13 monthly 0.8 https://www.510kdatabase.net/og-image/k260130-willow-18-guidewire-fda-510k.jpg K260130 - Willow 18 Guidewire K260130 is a FDA 510(k) cleared neurology medical device. Manufacturer: Arbor Endovascular, LLC. Cleared Feb 2026. https://www.510kdatabase.net/k251375/ 2026-02-12 monthly 0.8 https://www.510kdatabase.net/og-image/k251375-puracath-firefly-needleless-connector-fda-510k.jpg K251375 - PuraCath Firefly Needleless Connector IT (9005) K251375 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Puracath Medical, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k251732/ 2026-02-12 monthly 0.8 https://www.510kdatabase.net/og-image/k251732-wrist-fracture-system-fda-510k.jpg K251732 - Wrist Fracture System K251732 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Met One Technologies, LLC. Cleared Feb 2026. https://www.510kdatabase.net/k251760/ 2026-02-12 monthly 0.8 https://www.510kdatabase.net/og-image/k251760-well-life-incontinence-stimulation-fda-510k.jpg K251760 - Well-Life Incontinence Stimulation System (WL-2405i(P)) K251760 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Well-Life Healthcare , Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k252490/ 2026-02-12 monthly 0.8 https://www.510kdatabase.net/og-image/k252490-heel-stick-safety-lancet-hhz-ii-hhz-fda-510k.jpg K252490 - Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV) K252490 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Tianjin Huahong Technology Co., Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k252523/ 2026-02-12 monthly 0.8 https://www.510kdatabase.net/og-image/k252523-healgen-accurate-oral-fluid-drug-test-fda-510k.jpg K252523 - Healgen® Accurate Oral Fluid Drug Test COT/THC K252523 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Healgen Scientific, LLC. Cleared Feb 2026. https://www.510kdatabase.net/k253201/ 2026-02-12 monthly 0.8 https://www.510kdatabase.net/og-image/k253201-lumbar-spine-truss-system-plating-fda-510k.jpg K253201 - Lumbar Spine Truss System - Plating Solution (LSTS-PS) K253201 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 4Web, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k253354/ 2026-02-12 monthly 0.8 https://www.510kdatabase.net/og-image/k253354-minvitro-embryo-transfer-catheters-fda-510k.jpg K253354 - Minvitro Embryo Transfer Catheters (ETCA23175, ETCA23175-C, ETCB20175, ETCB20175-C, ETCB20175-ET, ETCB20175-ET-C) K253354 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Guangzhou Hehong Biotech Co., Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k253381/ 2026-02-12 monthly 0.8 https://www.510kdatabase.net/og-image/k253381-stealth-axis-surgical-system-with-fda-510k.jpg K253381 - Stealth AXiS™ Surgical System with Stealth AXiS™ Spine clinical application K253381 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Navigation, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k253490/ 2026-02-12 monthly 0.8 https://www.510kdatabase.net/og-image/k253490-glucose-hk-gen3-fda-510k.jpg K253490 - Glucose HK Gen.3 K253490 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Feb 2026. https://www.510kdatabase.net/k253491/ 2026-02-12 monthly 0.8 https://www.510kdatabase.net/og-image/k253491-ise-indirect-k-for-gen2-fda-510k.jpg K253491 - ISE indirect K for Gen.2 K253491 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Feb 2026. https://www.510kdatabase.net/k253972/ 2026-02-12 monthly 0.8 https://www.510kdatabase.net/og-image/k253972-image1-tc400us-fda-510k.jpg K253972 - IMAGE1 (TC400US) K253972 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Karl Storz SE & CO. KG. Cleared Feb 2026. https://www.510kdatabase.net/k254007/ 2026-02-12 monthly 0.8 https://www.510kdatabase.net/og-image/k254007-led-light-therapy-silicone-face-mask-fda-510k.jpg K254007 - LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281) K254007 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: SZ KKS Silicone&Electronic Co., Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k260108/ 2026-02-12 monthly 0.8 https://www.510kdatabase.net/og-image/k260108-l12-led-light-source-with-aim-fda-510k.jpg K260108 - L12 LED Light Source with AIM K260108 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker Endoscopy. Cleared Feb 2026. https://www.510kdatabase.net/k260177/ 2026-02-12 monthly 0.8 https://www.510kdatabase.net/og-image/k260177-saberscope-laparoscope-sas-a-536l-fda-510k.jpg K260177 - Saberscope™ Laparoscope (SAS-A-536L) K260177 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Xenocor, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k251592/ 2026-02-11 monthly 0.8 https://www.510kdatabase.net/og-image/k251592-sterihub-disinfecting-device-and-fda-510k.jpg K251592 - SteriHub™ Disinfecting Device and Protective Cover K251592 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 1World Vista Medical. Cleared Feb 2026. https://www.510kdatabase.net/k251813/ 2026-02-11 monthly 0.8 https://www.510kdatabase.net/og-image/k251813-curis-ii-rf-generator-ref-360100-05-fda-510k.jpg K251813 - CURIS II RF Generator (REF 360100-05) K251813 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sutter Medizintechnik GmbH. Cleared Feb 2026. https://www.510kdatabase.net/k251992/ 2026-02-11 monthly 0.8 https://www.510kdatabase.net/og-image/k251992-armsure-fluoroscopic-positioning-system-fda-510k.jpg K251992 - ArmSure Fluoroscopic Positioning System K251992 is a FDA 510(k) cleared radiology medical device. Manufacturer: Savfe Co. , Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k252084/ 2026-02-11 monthly 0.8 https://www.510kdatabase.net/og-image/k252084-ai4cmr-v20-fda-510k.jpg K252084 - AI4CMR v2.0 K252084 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ai4medimaging Medical Solutions S.A.. Cleared Feb 2026. https://www.510kdatabase.net/k253032/ 2026-02-11 monthly 0.8 https://www.510kdatabase.net/og-image/k253032-axs-lift-intracranial-base-catheter-fda-510k.jpg K253032 - AXS Lift Intracranial Base Catheter K253032 is a FDA 510(k) cleared neurology medical device. Manufacturer: Stryker Neurovascular. Cleared Feb 2026. https://www.510kdatabase.net/k253049/ 2026-02-11 monthly 0.8 https://www.510kdatabase.net/og-image/k253049-resona-a10s-resona-a20-pro-resona-a20t-fda-510k.jpg K253049 - Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System K253049 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k253488/ 2026-02-11 monthly 0.8 https://www.510kdatabase.net/og-image/k253488-ifuse-intra-ti-implant-system-fda-510k.jpg K253488 - iFuse INTRA Ti™ Implant System K253488 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SI-BONE, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/den250007/ 2026-02-11 monthly 0.8 https://www.510kdatabase.net/og-image/den250007-delivery-date-ai-fda-510k.jpg DEN250007 - Delivery Date AI DEN250007 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ultrasound AI. Cleared Feb 2026. https://www.510kdatabase.net/k251515/ 2026-02-10 monthly 0.8 https://www.510kdatabase.net/og-image/k251515-solidex-ti-links-and-screws-fda-510k.jpg K251515 - Solidex® Ti-Links and Screws K251515 is a FDA 510(k) cleared dental medical device. Manufacturer: CreoDent Hudson Valley. Cleared Feb 2026. https://www.510kdatabase.net/k251672/ 2026-02-10 monthly 0.8 https://www.510kdatabase.net/og-image/k251672-nim-essence-emg-endotracheal-tube-fda-510k.jpg K251672 - NIM Essence™ EMG Endotracheal Tube (NIMEID060) K251672 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Medtronic Xomed, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k252175/ 2026-02-10 monthly 0.8 https://www.510kdatabase.net/og-image/k252175-landr-contact-lens-case-fda-510k.jpg K252175 - LANDR Contact LENS Case K252175 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Fourth Axis, LLC. Cleared Feb 2026. https://www.510kdatabase.net/k252179/ 2026-02-10 monthly 0.8 https://www.510kdatabase.net/og-image/k252179-gem-flex-coil-16-l-array-15t-receive-fda-510k.jpg K252179 - GEM Flex Coil 16-L Array, 1.5T Receive Only K252179 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen RF Tech Co., Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k252459/ 2026-02-10 monthly 0.8 https://www.510kdatabase.net/og-image/k252459-multiflux-130-f00013123-fda-510k.jpg K252459 - multiFlux 130 (F00013123) K252459 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC. Cleared Feb 2026. https://www.510kdatabase.net/k252751/ 2026-02-10 monthly 0.8 https://www.510kdatabase.net/og-image/k252751-earflo-ef001-fda-510k.jpg K252751 - Earflo (EF001) K252751 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Earflo, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k253140/ 2026-02-10 monthly 0.8 https://www.510kdatabase.net/og-image/k253140-collovine-wound-powder-fda-510k.jpg K253140 - CollOvine™ Wound Powder K253140 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ovigenex, LLC. Cleared Feb 2026. https://www.510kdatabase.net/k253545/ 2026-02-10 monthly 0.8 https://www.510kdatabase.net/og-image/k253545-vulcan-spinal-system-fda-510k.jpg K253545 - Vulcan Spinal System K253545 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: K2m, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k254016/ 2026-02-10 monthly 0.8 https://www.510kdatabase.net/og-image/k254016-mi-viewgo-fda-510k.jpg K254016 - MI View&GO K254016 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k260073/ 2026-02-10 monthly 0.8 https://www.510kdatabase.net/og-image/k260073-xt3-system-fda-510k.jpg K260073 - XT3 System K260073 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biodynamik, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k260119/ 2026-02-10 monthly 0.8 https://www.510kdatabase.net/og-image/k260119-spaceoar-vue-system-sv-2101-fda-510k.jpg K260119 - SpaceOAR Vue System (SV-2101) K260119 is a FDA 510(k) cleared radiology medical device. Manufacturer: Boston Scientific Corporation. Cleared Feb 2026. https://www.510kdatabase.net/k251591/ 2026-02-09 monthly 0.8 https://www.510kdatabase.net/og-image/k251591-holter-ecg-and-abp-system-holterabp-fda-510k.jpg K251591 - Holter ECG and ABP system (HolterABP) K251591 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edan Instruments, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k254033/ 2026-02-09 monthly 0.8 https://www.510kdatabase.net/og-image/k254033-ceribell-instant-eeg-headset-fda-510k.jpg K254033 - Ceribell Instant EEG Headset K254033 is a FDA 510(k) cleared neurology medical device. Manufacturer: Ceribell, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k254236/ 2026-02-09 monthly 0.8 https://www.510kdatabase.net/og-image/k254236-peel-away-introducer-sheath-fda-510k.jpg K254236 - Peel-Away Introducer Sheath K254236 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: VascuTech Medical, LLC. Cleared Feb 2026. https://www.510kdatabase.net/k243348/ 2026-02-06 monthly 0.8 https://www.510kdatabase.net/og-image/k243348-athelas-home-fda-510k.jpg K243348 - Athelas Home K243348 is a FDA 510(k) cleared hematology medical device. Manufacturer: Athelas, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k243979/ 2026-02-06 monthly 0.8 https://www.510kdatabase.net/og-image/k243979-aptiva-aps-iga-reagent-fda-510k.jpg K243979 - Aptiva APS IgA Reagent K243979 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k251218/ 2026-02-06 monthly 0.8 https://www.510kdatabase.net/og-image/k251218-safebeat-rx-app-fda-510k.jpg K251218 - SafeBeat Rx App K251218 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Safebeat Rx, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k251423/ 2026-02-06 monthly 0.8 https://www.510kdatabase.net/og-image/k251423-spectra-s1-pro-fda-510k.jpg K251423 - Spectra S1 Pro K251423 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Uzinmedicare Co., Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k251474/ 2026-02-06 monthly 0.8 https://www.510kdatabase.net/og-image/k251474-median-lcs-internal-name-eyonis-lcs-fda-510k.jpg K251474 - Median LCS (internal name) / eyonis LCS (trade name) (1.0) K251474 is a FDA 510(k) cleared radiology medical device. Manufacturer: Median Technologies. Cleared Feb 2026. https://www.510kdatabase.net/k251507/ 2026-02-06 monthly 0.8 https://www.510kdatabase.net/og-image/k251507-integre-lio-fda-510k.jpg K251507 - INTEGRE LIO K251507 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Quantel Medical. Cleared Feb 2026. https://www.510kdatabase.net/k251543/ 2026-02-06 monthly 0.8 https://www.510kdatabase.net/og-image/k251543-atellica-im-tsh3-ultra-ii-tsh3ulii-fda-510k.jpg K251543 - Atellica® IM TSH3-Ultra II (TSH3ULII) K251543 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k251577/ 2026-02-06 monthly 0.8 https://www.510kdatabase.net/og-image/k251577-laia-xr-fda-510k.jpg K251577 - LAIA XR K251577 is a FDA 510(k) cleared radiology medical device. Manufacturer: Augmented Reality Software S.L.. Cleared Feb 2026. https://www.510kdatabase.net/k251614/ 2026-02-06 monthly 0.8 https://www.510kdatabase.net/og-image/k251614-stainless-steel-surgical-kits-fda-510k.jpg K251614 - Stainless Steel Surgical Kits K251614 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Dentsply Sirona, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k251836/ 2026-02-06 monthly 0.8 https://www.510kdatabase.net/og-image/k251836-dermatrix-duo-fda-510k.jpg K251836 - Dermatrix Duo K251836 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Gsd Technology Co., Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k252058/ 2026-02-06 monthly 0.8 https://www.510kdatabase.net/og-image/k252058-rosa-knee-system-with-ultrasound-fda-510k.jpg K252058 - ROSA Knee System with UltraSound Imaging Platform (USIP) K252058 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Balmoral Medical, LLC. Cleared Feb 2026. https://www.510kdatabase.net/k252076/ 2026-02-06 monthly 0.8 https://www.510kdatabase.net/og-image/k252076-kneevoice-cartilage-evaluation-system-fda-510k.jpg K252076 - Kneevoice Cartilage Evaluation System (750-3600-001) K252076 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Kneevoice, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k252726/ 2026-02-06 monthly 0.8 https://www.510kdatabase.net/og-image/k252726-intellivue-multi-measurement-module-x3-fda-510k.jpg K252726 - IntelliVue Multi-Measurement Module X3 (867030) K252726 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Philips Medizin Systeme Boeblingen GmbH. Cleared Feb 2026. https://www.510kdatabase.net/k252871/ 2026-02-06 monthly 0.8 https://www.510kdatabase.net/og-image/k252871-spine-guidance-53-software-fda-510k.jpg K252871 - Spine Guidance 5.3 Software K252871 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Leibinger GmbH & Co KG. Cleared Feb 2026. https://www.510kdatabase.net/k252873/ 2026-02-06 monthly 0.8 https://www.510kdatabase.net/og-image/k252873-q-interbody-instruments-fda-510k.jpg K252873 - Q Interbody Instruments K252873 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: K2m, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k253221/ 2026-02-06 monthly 0.8 https://www.510kdatabase.net/og-image/k253221-liver-fat-ultrasound-quantitative-fda-510k.jpg K253221 - Liver fat ultrasound quantitative system, The FattaLab (FL-CC M1, FL-CC M1_Pro) K253221 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eieling Technology (Shenzhen) Limited. Cleared Feb 2026. https://www.510kdatabase.net/k253568/ 2026-02-06 monthly 0.8 https://www.510kdatabase.net/og-image/k253568-hood-dh-084str-fda-510k.jpg K253568 - Hood DH-084STR K253568 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fujifilm Corporation. Cleared Feb 2026. https://www.510kdatabase.net/k253780/ 2026-02-06 monthly 0.8 https://www.510kdatabase.net/og-image/k253780-signa-bolt-fda-510k.jpg K253780 - SIGNA™ Bolt K253780 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems, LLC. Cleared Feb 2026. https://www.510kdatabase.net/k253852/ 2026-02-06 monthly 0.8 https://www.510kdatabase.net/og-image/k253852-monocryl-plus-antibacterial-fda-510k.jpg K253852 - MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthetic Absorbable Surgical Suture K253852 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k253927/ 2026-02-06 monthly 0.8 https://www.510kdatabase.net/og-image/k253927-livemedica-enterprise-pacs-fda-510k.jpg K253927 - LiveMedica Enterprise PACS K253927 is a FDA 510(k) cleared radiology medical device. Manufacturer: Live Medica, LLC. Cleared Feb 2026. https://www.510kdatabase.net/den250006/ 2026-02-06 monthly 0.8 https://www.510kdatabase.net/og-image/den250006-amferia-wound-dressing-fda-510k.jpg DEN250006 - Amferia Wound Dressing DEN250006 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Amferia AB. Cleared Feb 2026. https://www.510kdatabase.net/k251517/ 2026-02-05 monthly 0.8 https://www.510kdatabase.net/og-image/k251517-encora-x1-fda-510k.jpg K251517 - Encora X1 K251517 is a FDA 510(k) cleared neurology medical device. Manufacturer: Encora, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k251949/ 2026-02-05 monthly 0.8 https://www.510kdatabase.net/og-image/k251949-indigo-aspiration-system-lightning-fda-510k.jpg K251949 - INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK K251949 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Penumbra, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k253779/ 2026-02-05 monthly 0.8 https://www.510kdatabase.net/og-image/k253779-signa-sprint-select-fda-510k.jpg K253779 - SIGNA™ Sprint Select K253779 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems, LLC. Cleared Feb 2026. https://www.510kdatabase.net/k253959/ 2026-02-05 monthly 0.8 https://www.510kdatabase.net/og-image/k253959-primevision-3d-fda-510k.jpg K253959 - Primevision 3D K253959 is a FDA 510(k) cleared radiology medical device. Manufacturer: Dentsply Sirona. Cleared Feb 2026. https://www.510kdatabase.net/k260028/ 2026-02-05 monthly 0.8 https://www.510kdatabase.net/og-image/k260028-cleaner-vac-thrombectomy-system-fda-510k.jpg K260028 - CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece, CLEANER™ Vac Aspiration Canister K260028 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Argon Medical Devices, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k250773/ 2026-02-04 monthly 0.8 https://www.510kdatabase.net/og-image/k250773-luna-ti-interbody-fusion-system-fda-510k.jpg K250773 - Luna® Ti Interbody Fusion System K250773 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinal Elements, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k252301/ 2026-02-04 monthly 0.8 https://www.510kdatabase.net/og-image/k252301-henan-yadu-level-4-surgical-gowns-fda-510k.jpg K252301 - Henan Yadu Level 4 Surgical Gowns (Reinforced) K252301 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Yadu Medical (Henan) Co., Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k252623/ 2026-02-04 monthly 0.8 https://www.510kdatabase.net/og-image/k252623-g7-revision-acetabular-system-fda-510k.jpg K252623 - G7® Revision Acetabular System K252623 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k260012/ 2026-02-04 monthly 0.8 https://www.510kdatabase.net/og-image/k260012-ultrascore-focused-force-pta-balloon-fda-510k.jpg K260012 - UltraScore™ Focused Force PTA Balloon K260012 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bard Peripheral Vascular, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k260038/ 2026-02-04 monthly 0.8 https://www.510kdatabase.net/og-image/k260038-e3d-c-interbody-system-fda-510k.jpg K260038 - E3D™-C Interbody System K260038 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Evolution Spine. Cleared Feb 2026. https://www.510kdatabase.net/k260104/ 2026-02-04 monthly 0.8 https://www.510kdatabase.net/og-image/k260104-signature-one-system-fda-510k.jpg K260104 - Signature™ ONE System K260104 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthosoft Inc. (d/b/a) Zimmer CAS. Cleared Feb 2026. https://www.510kdatabase.net/k250644/ 2026-02-03 monthly 0.8 https://www.510kdatabase.net/og-image/k250644-mss-monobloc-stem-fda-510k.jpg K250644 - MSS - Monobloc stem K250644 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Feb 2026. https://www.510kdatabase.net/k252048/ 2026-02-03 monthly 0.8 https://www.510kdatabase.net/og-image/k252048-808nm-semiconductor-laser-hair-removal-fda-510k.jpg K252048 - 808nm semiconductor laser hair removal machine K252048 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Xi'An Taibo Electronic Technology Co., Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k252087/ 2026-02-03 monthly 0.8 https://www.510kdatabase.net/og-image/k252087-navigation-module-of-the-cortium-system-fda-510k.jpg K252087 - Navigation Module of the Cortium® System K252087 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ulrich Medical USA, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k252438/ 2026-02-03 monthly 0.8 https://www.510kdatabase.net/og-image/k252438-explant-express-fda-510k.jpg K252438 - Explant Express K252438 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Applied Medical Technology, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k252676/ 2026-02-03 monthly 0.8 https://www.510kdatabase.net/og-image/k252676-the-circadia-c300-system-c300-fda-510k.jpg K252676 - The Circadia C300 System (C300) K252676 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Circadia Health, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k252909/ 2026-02-03 monthly 0.8 https://www.510kdatabase.net/og-image/k252909-diagnostic-x-ray-equipment-model-poct22-fda-510k.jpg K252909 - Diagnostic X-Ray Equipment Model POCT22 K252909 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ningbo Runyes Medical Instrument Co., Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k253282/ 2026-02-03 monthly 0.8 https://www.510kdatabase.net/og-image/k253282-zsmile-system-fda-510k.jpg K253282 - ZSmile System K253282 is a FDA 510(k) cleared dental medical device. Manufacturer: Dror Orthodesign , Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k253640/ 2026-02-03 monthly 0.8 https://www.510kdatabase.net/og-image/k253640-t2-alpha-femur-retrograde-nailing-system-fda-510k.jpg K253640 - T2 Alpha Femur Retrograde Nailing System K253640 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker GmbH. Cleared Feb 2026. https://www.510kdatabase.net/k253701/ 2026-02-03 monthly 0.8 https://www.510kdatabase.net/og-image/k253701-smartguard-technology-fda-510k.jpg K253701 - SmartGuard Technology K253701 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Medtronic Minimed. Cleared Feb 2026. https://www.510kdatabase.net/k253737/ 2026-02-03 monthly 0.8 https://www.510kdatabase.net/og-image/k253737-dexcom-g7-continuous-glucose-fda-510k.jpg K253737 - Dexcom G7 Continuous Glucose Monitoring (CGM) System K253737 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dexcom, Inc.. Cleared Feb 2026. https://www.510kdatabase.net/k251200/ 2026-02-02 monthly 0.8 https://www.510kdatabase.net/og-image/k251200-vital-signs-fda-510k.jpg K251200 - Vital Signs K251200 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Oxehealth Limited. Cleared Feb 2026. https://www.510kdatabase.net/k251582/ 2026-02-02 monthly 0.8 https://www.510kdatabase.net/og-image/k251582-redermax-antibacterial-wound-matrix-fda-510k.jpg K251582 - Redermax Antibacterial Wound Matrix K251582 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Beijing Kreate Medical Co., Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k252011/ 2026-02-02 monthly 0.8 https://www.510kdatabase.net/og-image/k252011-chikai-nexus-petit-fda-510k.jpg K252011 - CHIKAI Nexus petit K252011 is a FDA 510(k) cleared neurology medical device. Manufacturer: Asahi Intecc Co., Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k252286/ 2026-02-02 monthly 0.8 https://www.510kdatabase.net/og-image/k252286-biores-dental-implant-system-fda-510k.jpg K252286 - BIORES Dental Implant System K252286 is a FDA 510(k) cleared dental medical device. Manufacturer: Chengdu Besmile Medical Technology Co., Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k252649/ 2026-02-02 monthly 0.8 https://www.510kdatabase.net/og-image/k252649-tap2d-fda-510k.jpg K252649 - TAP2D K252649 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nano-X Imaging , Ltd.. Cleared Feb 2026. https://www.510kdatabase.net/k253847/ 2026-01-31 monthly 0.8 https://www.510kdatabase.net/og-image/k253847-splashwire-hydrophilic-guide-wire-fda-510k.jpg K253847 - Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) K253847 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Ireland, Ltd.. Cleared Jan 2026. https://www.510kdatabase.net/k250983/ 2026-01-30 monthly 0.8 https://www.510kdatabase.net/og-image/k250983-medblue-skin-prick-test-applicator-fda-510k.jpg K250983 - Medblue Skin Prick Test Applicator (AS103, AS108, AS109, AS110, AS111, AS113, AS132, AS134, AS146, AS148, AS160, AS162, AS170, AS172) K250983 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Asistan Medikal. Cleared Jan 2026. https://www.510kdatabase.net/k251407/ 2026-01-30 monthly 0.8 https://www.510kdatabase.net/og-image/k251407-motor-handpiece-and-control-unit-sdi10-fda-510k.jpg K251407 - Motor Handpiece and Control Unit (SDI10) K251407 is a FDA 510(k) cleared dental medical device. Manufacturer: Saeshin Precision Co., Ltd.. Cleared Jan 2026. https://www.510kdatabase.net/k251769/ 2026-01-30 monthly 0.8 https://www.510kdatabase.net/og-image/k251769-revealai-lung-fda-510k.jpg K251769 - RevealAI-Lung K251769 is a FDA 510(k) cleared radiology medical device. Manufacturer: Precision Medical Ventures, Inc. Dba Revealdx. Cleared Jan 2026. https://www.510kdatabase.net/k251981/ 2026-01-30 monthly 0.8 https://www.510kdatabase.net/og-image/k251981-boston-pico-boston-pico-fda-510k.jpg K251981 - Boston PICO (Boston PICO) K251981 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Boston Aesthetics, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k252457/ 2026-01-30 monthly 0.8 https://www.510kdatabase.net/og-image/k252457-disposable-distal-end-tape-hood-fda-510k.jpg K252457 - Disposable Distal End Tape Hood K252457 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Shanghai SeeGen Photoelectric Technology Co., Ltd.. Cleared Jan 2026. https://www.510kdatabase.net/k253318/ 2026-01-30 monthly 0.8 https://www.510kdatabase.net/og-image/k253318-clungene-rsv-antigen-rapid-test-fda-510k.jpg K253318 - Clungene RSV Antigen Rapid Test K253318 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Hangzhou Clongene Biotech Co., Ltd.. Cleared Jan 2026. https://www.510kdatabase.net/k253671/ 2026-01-30 monthly 0.8 https://www.510kdatabase.net/og-image/k253671-dual-stage-venous-cannulae-fda-510k.jpg K253671 - Dual Stage Venous Cannulae K253671 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sorin Group Italia S.R.L.. Cleared Jan 2026. https://www.510kdatabase.net/k253833/ 2026-01-30 monthly 0.8 https://www.510kdatabase.net/og-image/k253833-facial-body-beauty-device-model-inia-fda-510k.jpg K253833 - Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507) K253833 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Jianchao Intelligent Technology Co., Ltd.. Cleared Jan 2026. https://www.510kdatabase.net/k254283/ 2026-01-30 monthly 0.8 https://www.510kdatabase.net/og-image/k254283-bruxzir-shaded-16-plus-fda-510k.jpg K254283 - BruxZir® Shaded 16 PLUS K254283 is a FDA 510(k) cleared dental medical device. Manufacturer: Prismatik Dentalcraft, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k254290/ 2026-01-30 monthly 0.8 https://www.510kdatabase.net/og-image/k254290-zentite-unicorn-fda-510k.jpg K254290 - ZenTite (Unicorn+) K254290 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Peninsula Medical Group. Cleared Jan 2026. https://www.510kdatabase.net/k254305/ 2026-01-30 monthly 0.8 https://www.510kdatabase.net/og-image/k254305-baroguard-donor-lung-preservation-system-fda-510k.jpg K254305 - BAROguard Donor Lung Preservation System K254305 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Paragonix Technologies, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k243732/ 2026-01-29 monthly 0.8 https://www.510kdatabase.net/og-image/k243732-multi-unit-das-system-fda-510k.jpg K243732 - Multi-Unit DAS System K243732 is a FDA 510(k) cleared dental medical device. Manufacturer: Talladium Espa?a, SL. Cleared Jan 2026. https://www.510kdatabase.net/k251274/ 2026-01-29 monthly 0.8 https://www.510kdatabase.net/og-image/k251274-ez-protect-hydrophilic-closed-system-fda-510k.jpg K251274 - EZ-Protect Hydrophilic Closed System Intermittent Catheter K251274 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: HR Healthcare. Cleared Jan 2026. https://www.510kdatabase.net/k251354/ 2026-01-29 monthly 0.8 https://www.510kdatabase.net/og-image/k251354-uv-smart-d60-fda-510k.jpg K251354 - UV Smart D60 K251354 is a FDA 510(k) cleared general hospital medical device. Manufacturer: UV Smart Technologies B.V.. Cleared Jan 2026. https://www.510kdatabase.net/k251427/ 2026-01-29 monthly 0.8 https://www.510kdatabase.net/og-image/k251427-ek-multi-angled-30-abutment-fda-510k.jpg K251427 - EK MULTI ANGLED 30 ABUTMENT K251427 is a FDA 510(k) cleared dental medical device. Manufacturer: Hiossen, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k251923/ 2026-01-29 monthly 0.8 https://www.510kdatabase.net/og-image/k251923-medical-shaver-system-morcellator-ysb-fda-510k.jpg K251923 - Medical Shaver System (Morcellator) (YSB-IIIA) K251923 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hangzhou Hawk Optical Electronic Instruments Co., Ltd.. Cleared Jan 2026. https://www.510kdatabase.net/k252091/ 2026-01-29 monthly 0.8 https://www.510kdatabase.net/og-image/k252091-surgical-reality-viewer-fda-510k.jpg K252091 - Surgical Reality Viewer K252091 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medicalvr B.V.. Cleared Jan 2026. https://www.510kdatabase.net/k252275/ 2026-01-29 monthly 0.8 https://www.510kdatabase.net/og-image/k252275-electric-scooter-ddf100-fda-510k.jpg K252275 - Electric Scooter (DDF100) K252275 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zhejiang Nysin Medical Co., Ltd.. Cleared Jan 2026. https://www.510kdatabase.net/k252347/ 2026-01-29 monthly 0.8 https://www.510kdatabase.net/og-image/k252347-electric-scooter-mojo-t580-fda-510k.jpg K252347 - Electric Scooter (Mojo-T580) K252347 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Dongguan Smarfody Mobility Technology Co., Ltd.. Cleared Jan 2026. https://www.510kdatabase.net/k252349/ 2026-01-29 monthly 0.8 https://www.510kdatabase.net/og-image/k252349-electric-scooter-mojo-t330-fda-510k.jpg K252349 - Electric Scooter (Mojo-T330) K252349 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Dongguan Smarfody Mobility Technology Co., Ltd.. Cleared Jan 2026. https://www.510kdatabase.net/k252496/ 2026-01-29 monthly 0.8 https://www.510kdatabase.net/og-image/k252496-neurophet-aqua-ad-plus-fda-510k.jpg K252496 - Neurophet AQUA AD Plus K252496 is a FDA 510(k) cleared radiology medical device. Manufacturer: Neurophet., Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k252684/ 2026-01-29 monthly 0.8 https://www.510kdatabase.net/og-image/k252684-labcorp-fentanyl-urine-visual-test-fda-510k.jpg K252684 - Labcorp Fentanyl Urine Visual Test K252684 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Medtox Diagnostics, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k253462/ 2026-01-29 monthly 0.8 https://www.510kdatabase.net/og-image/k253462-naturalyte-dry-bicarbonate-concentrate-fda-510k.jpg K253462 - NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2) K253462 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC. Cleared Jan 2026. https://www.510kdatabase.net/k253611/ 2026-01-29 monthly 0.8 https://www.510kdatabase.net/og-image/k253611-falco-fusion-system-fda-510k.jpg K253611 - Falco Fusion System K253611 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Mcnicoll Surgical, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k253632/ 2026-01-29 monthly 0.8 https://www.510kdatabase.net/og-image/k253632-manual-wheelchair-w50-fda-510k.jpg K253632 - Manual Wheelchair (W50) K253632 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Jiangsu Jumao X-Care Medical Equipment Co., Ltd.. Cleared Jan 2026. https://www.510kdatabase.net/k253763/ 2026-01-29 monthly 0.8 https://www.510kdatabase.net/og-image/k253763-y-knotless-flex-anchors-fda-510k.jpg K253763 - Y-Knotless™ Flex Anchors K253763 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Conmed Corporation. Cleared Jan 2026. https://www.510kdatabase.net/k251043/ 2026-01-28 monthly 0.8 https://www.510kdatabase.net/og-image/k251043-mpact-3d-metal-implants-extension-dmls-fda-510k.jpg K251043 - Mpact 3D Metal Implants Extension – DMLS Technology K251043 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Jan 2026. https://www.510kdatabase.net/k251306/ 2026-01-28 monthly 0.8 https://www.510kdatabase.net/og-image/k251306-seg-pro-v3-rt-300-fda-510k.jpg K251306 - Seg Pro V3 (RT-300) K251306 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ever Fortune.Ai, Co., Ltd.. Cleared Jan 2026. https://www.510kdatabase.net/k251347/ 2026-01-28 monthly 0.8 https://www.510kdatabase.net/og-image/k251347-sterilization-pouchroll-fda-510k.jpg K251347 - Sterilization Pouch/Roll K251347 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sterivic Medical Co., Ltd.. Cleared Jan 2026. https://www.510kdatabase.net/k251622/ 2026-01-28 monthly 0.8 https://www.510kdatabase.net/og-image/k251622-hand-massager-sm004d-fda-510k.jpg K251622 - Hand Massager (SM004D) K251622 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Ningbo Zhenhai Yihao Electronic Technology Co., Ltd.. Cleared Jan 2026. https://www.510kdatabase.net/k251896/ 2026-01-28 monthly 0.8 https://www.510kdatabase.net/og-image/k251896-xelitemed-superm-fix-spinal-bone-cement-fda-510k.jpg K251896 - XeliteMed SuperM-Fix Spinal Bone Cement K251896 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Xelite Biomed , Ltd.. Cleared Jan 2026. https://www.510kdatabase.net/k252015/ 2026-01-28 monthly 0.8 https://www.510kdatabase.net/og-image/k252015-freedomedge-infusion-system-fda-510k.jpg K252015 - FreedomEdge Infusion System K252015 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Koru Medical Systems, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k252164/ 2026-01-28 monthly 0.8 https://www.510kdatabase.net/og-image/k252164-northstar-mapping-system-fda-510k.jpg K252164 - NorthStar™ Mapping System K252164 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Imricor Medical Systems. Cleared Jan 2026. https://www.510kdatabase.net/k252603/ 2026-01-28 monthly 0.8 https://www.510kdatabase.net/og-image/k252603-higherdose-body-sculptor-model-gs-03-fda-510k.jpg K252603 - HIGHERDOSE Body Sculptor (Model: GS-03) K252603 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Kaiyan Medical Equipment Co., Ltd.. Cleared Jan 2026. https://www.510kdatabase.net/k252834/ 2026-01-28 monthly 0.8 https://www.510kdatabase.net/og-image/k252834-sacroiliac-joint-truss-system-sjts-fda-510k.jpg K252834 - Sacroiliac Joint Truss System (SJTS) K252834 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 4Web Medical. Cleared Jan 2026. https://www.510kdatabase.net/k253224/ 2026-01-28 monthly 0.8 https://www.510kdatabase.net/og-image/k253224-mysozo-software-version-6012-sw-fda-510k.jpg K253224 - MySOZO Software version 6.0.1.2 (SW version 6.0.1.2) K253224 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: ImpediMed Limited. Cleared Jan 2026. https://www.510kdatabase.net/k253254/ 2026-01-28 monthly 0.8 https://www.510kdatabase.net/og-image/k253254-gbt-machine-airflow-prophylaxis-master-fda-510k.jpg K253254 - GBT Machine Airflow Prophylaxis Master K253254 is a FDA 510(k) cleared dental medical device. Manufacturer: E.M.S Electro Medical Systems S.A. Cleared Jan 2026. https://www.510kdatabase.net/k253388/ 2026-01-28 monthly 0.8 https://www.510kdatabase.net/og-image/k253388-sleepiz-one-model-25-fda-510k.jpg K253388 - Sleepiz One+ (Model 2.5) K253388 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sleepiz AG. Cleared Jan 2026. https://www.510kdatabase.net/k253842/ 2026-01-28 monthly 0.8 https://www.510kdatabase.net/og-image/k253842-vena-microangioscope-system-fda-510k.jpg K253842 - Vena MicroAngioscope™ System K253842 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vena Medical Holdings Corp. Cleared Jan 2026. https://www.510kdatabase.net/k260004/ 2026-01-28 monthly 0.8 https://www.510kdatabase.net/og-image/k260004-aevumed-protekt-suture-anchor-fda-510k.jpg K260004 - Aevumed PROTEKT Suture Anchor K260004 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aevumed, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k251195/ 2026-01-27 monthly 0.8 https://www.510kdatabase.net/og-image/k251195-briefcase-triage-fda-510k.jpg K251195 - BriefCase-Triage K251195 is a FDA 510(k) cleared radiology medical device. Manufacturer: Aidoc Medical , Ltd.. Cleared Jan 2026. https://www.510kdatabase.net/k251435/ 2026-01-27 monthly 0.8 https://www.510kdatabase.net/og-image/k251435-inbellaignite-rf-system-fda-510k.jpg K251435 - InbellaIgnite RF System K251435 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Inbella Medical, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k251995/ 2026-01-27 monthly 0.8 https://www.510kdatabase.net/og-image/k251995-access-anti-hav-igm-fda-510k.jpg K251995 - Access anti-HAV IgM K251995 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k254220/ 2026-01-27 monthly 0.8 https://www.510kdatabase.net/og-image/k254220-reusable-3-button-fingerswitch-wand-fda-510k.jpg K254220 - Reusable 3 Button Fingerswitch Wand K254220 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Soniquence, LLC. Cleared Jan 2026. https://www.510kdatabase.net/k254221/ 2026-01-27 monthly 0.8 https://www.510kdatabase.net/og-image/k254221-optima-coil-system-optione-coil-system-fda-510k.jpg K254221 - Optima Coil System (OptiOne Coil System) K254221 is a FDA 510(k) cleared neurology medical device. Manufacturer: Balt USA, LLC. Cleared Jan 2026. https://www.510kdatabase.net/k251670/ 2026-01-26 monthly 0.8 https://www.510kdatabase.net/og-image/k251670-mac-7-resting-ecg-analysis-system-fda-510k.jpg K251670 - MAC 7 Resting ECG Analysis System K251670 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k253412/ 2026-01-26 monthly 0.8 https://www.510kdatabase.net/og-image/k253412-tablo-hemodialysis-system-pn-0008000-fda-510k.jpg K253412 - Tablo Hemodialysis System (PN-0008000, PN-0006000U) K253412 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Outset Medical, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k253499/ 2026-01-26 monthly 0.8 https://www.510kdatabase.net/og-image/k253499-ascent3t-neonatal-magnetic-resonance-fda-510k.jpg K253499 - Ascent3T Neonatal Magnetic Resonance Imaging System K253499 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eyas Medical Imaging, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k252753/ 2026-01-24 monthly 0.8 https://www.510kdatabase.net/og-image/k252753-vydence-family-of-lasers-fda-510k.jpg K252753 - Vydence Family of Lasers K252753 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Vydence Medical Industria E Commercio Ltda. Cleared Jan 2026. https://www.510kdatabase.net/k253633/ 2026-01-24 monthly 0.8 https://www.510kdatabase.net/og-image/k253633-holmium-laser-therapeutic-apparatus-hz-fda-510k.jpg K253633 - Holmium Laser Therapeutic Apparatus (HZ-40) K253633 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.. Cleared Jan 2026. https://www.510kdatabase.net/k243349/ 2026-01-23 monthly 0.8 https://www.510kdatabase.net/og-image/k243349-bodyguardian-remote-monitoring-system-fda-510k.jpg K243349 - BodyGuardian Remote Monitoring System (BGRMS v3.0) K243349 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Cardiac Diagnostic Technologies, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k250741/ 2026-01-23 monthly 0.8 https://www.510kdatabase.net/og-image/k250741-evidence-multistat-doa-urine-multiplex-fda-510k.jpg K250741 - Evidence MultiSTAT DOA Urine MultiPlex K250741 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Randox Laboratories Limited. Cleared Jan 2026. https://www.510kdatabase.net/k251351/ 2026-01-23 monthly 0.8 https://www.510kdatabase.net/og-image/k251351-accucontour-40-fda-510k.jpg K251351 - AccuContour 4.0 K251351 is a FDA 510(k) cleared radiology medical device. Manufacturer: Manteia Technologies Co., Ltd.. Cleared Jan 2026. https://www.510kdatabase.net/k252568/ 2026-01-23 monthly 0.8 https://www.510kdatabase.net/og-image/k252568-new-day-skin-spray-fda-510k.jpg K252568 - New Day Skin Spray K252568 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Silk Holdings, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k252755/ 2026-01-23 monthly 0.8 https://www.510kdatabase.net/og-image/k252755-point-kinguide-agile-robotic-arm-fda-510k.jpg K252755 - POINT Kinguide Agile Robotic Arm Surgical Stereotactic System K252755 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Point Robotics MedTech, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k252957/ 2026-01-23 monthly 0.8 https://www.510kdatabase.net/og-image/k252957-pneumo-dissector-hook-fda-510k.jpg K252957 - Pneumo Dissector Hook K252957 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ab Medica Sas. Cleared Jan 2026. https://www.510kdatabase.net/k253160/ 2026-01-23 monthly 0.8 https://www.510kdatabase.net/og-image/k253160-syntex-exam-gloves-fda-510k.jpg K253160 - Syntex Exam Gloves K253160 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Basic Medical Technology, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k253285/ 2026-01-23 monthly 0.8 https://www.510kdatabase.net/og-image/k253285-elitone-for-men-fda-510k.jpg K253285 - Elitone for Men K253285 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Elidah, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k253669/ 2026-01-23 monthly 0.8 https://www.510kdatabase.net/og-image/k253669-trudermal-halo-hair-growth-system-m-180a-fda-510k.jpg K253669 - TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A) K253669 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Kaiyan Medical Equipment Co., Ltd.. Cleared Jan 2026. https://www.510kdatabase.net/k253712/ 2026-01-23 monthly 0.8 https://www.510kdatabase.net/og-image/k253712-led-light-therapy-mask-rb-051-rb-061-fda-510k.jpg K253712 - LED Light Therapy Mask (RB-051, RB-061, RB-071, RB-052, RB-062, RB-072, RB-053, RB-063, RB-073) K253712 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Rainbow Technology Co., Ltd.. Cleared Jan 2026. https://www.510kdatabase.net/k253738/ 2026-01-23 monthly 0.8 https://www.510kdatabase.net/og-image/k253738-30t-air-32ch-hna-fda-510k.jpg K253738 - 3.0T AIR 32CH HNA K253738 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare Coils (Usa Instruments, Inc.). Cleared Jan 2026. https://www.510kdatabase.net/k253748/ 2026-01-23 monthly 0.8 https://www.510kdatabase.net/og-image/k253748-life-spine-prolift-prolift-lateral-and-fda-510k.jpg K253748 - Life Spine ProLift & ProLift Lateral and ProLift Lateral Fixated Expandable Spacer System K253748 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k253761/ 2026-01-23 monthly 0.8 https://www.510kdatabase.net/og-image/k253761-hydromark-plus-breast-biopsy-site-fda-510k.jpg K253761 - HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape) K253761 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Devicor Medical Products, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k251323/ 2026-01-22 monthly 0.8 https://www.510kdatabase.net/og-image/k251323-device-104-particulate-fda-510k.jpg K251323 - Device 104 Particulate K251323 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Geistlich Pharma AG. Cleared Jan 2026. https://www.510kdatabase.net/k251511/ 2026-01-22 monthly 0.8 https://www.510kdatabase.net/og-image/k251511-phenomatrix-fda-510k.jpg K251511 - PhenoMATRIX K251511 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Copan Wasp Srl. Cleared Jan 2026. https://www.510kdatabase.net/k252307/ 2026-01-22 monthly 0.8 https://www.510kdatabase.net/og-image/k252307-getinge-gss67n-series-steam-sterilizer-fda-510k.jpg K252307 - Getinge GSS67N Series Steam Sterilizer K252307 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Maquet GmbH (A Getinge Group Company). Cleared Jan 2026. https://www.510kdatabase.net/k252352/ 2026-01-22 monthly 0.8 https://www.510kdatabase.net/og-image/k252352-smr-shoulder-system-fda-510k.jpg K252352 - SMR Shoulder System K252352 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Lima Corporate S.P.A.. Cleared Jan 2026. https://www.510kdatabase.net/k252885/ 2026-01-22 monthly 0.8 https://www.510kdatabase.net/og-image/k252885-olympic-posterior-spinal-fixation-system-fda-510k.jpg K252885 - OLYMPIC Posterior Spinal Fixation System K252885 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Astura Medical. Cleared Jan 2026. https://www.510kdatabase.net/k252984/ 2026-01-22 monthly 0.8 https://www.510kdatabase.net/og-image/k252984-perin-health-system-phd80060-2-fda-510k.jpg K252984 - Perin Health System (PHD80060-2) K252984 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Perin Health Devices, LLC. Cleared Jan 2026. https://www.510kdatabase.net/k253057/ 2026-01-22 monthly 0.8 https://www.510kdatabase.net/og-image/k253057-ai-rad-companion-brain-mr-fda-510k.jpg K253057 - AI-Rad Companion Brain MR K253057 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Healthcare GmbH. Cleared Jan 2026. https://www.510kdatabase.net/k253253/ 2026-01-22 monthly 0.8 https://www.510kdatabase.net/og-image/k253253-ipdmilled-blanks-fda-510k.jpg K253253 - IPDmilled Blanks K253253 is a FDA 510(k) cleared dental medical device. Manufacturer: Implant Protesis Dental 2004, S.L.. Cleared Jan 2026. https://www.510kdatabase.net/k253315/ 2026-01-22 monthly 0.8 https://www.510kdatabase.net/og-image/k253315-straumann-variobase-abutments-xc-for-fda-510k.jpg K253315 - Straumann Variobase Abutments XC for Bridge/Bar K253315 is a FDA 510(k) cleared dental medical device. Manufacturer: Institut Straumann AG. Cleared Jan 2026. https://www.510kdatabase.net/k253498/ 2026-01-22 monthly 0.8 https://www.510kdatabase.net/og-image/k253498-pump-in-style-pro-fda-510k.jpg K253498 - Pump In Style® Pro+ K253498 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Medela, LLC. Cleared Jan 2026. https://www.510kdatabase.net/k253652/ 2026-01-22 monthly 0.8 https://www.510kdatabase.net/og-image/k253652-genie-max-large-bore-introducer-sheath-fda-510k.jpg K253652 - Genie MAX Large Bore Introducer Sheath K253652 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cultiv8 1, LLC. Cleared Jan 2026. https://www.510kdatabase.net/k253735/ 2026-01-22 monthly 0.8 https://www.510kdatabase.net/og-image/k253735-av-vascular-fda-510k.jpg K253735 - AV Vascular K253735 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Jan 2026. https://www.510kdatabase.net/k251281/ 2026-01-21 monthly 0.8 https://www.510kdatabase.net/og-image/k251281-nova-max-creat-egfr-monitoring-system-fda-510k.jpg K251281 - Nova Max Creat eGFR Monitoring System K251281 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Nova Biomedical Corporation. Cleared Jan 2026. https://www.510kdatabase.net/k251286/ 2026-01-21 monthly 0.8 https://www.510kdatabase.net/og-image/k251286-affirm-400-fda-510k.jpg K251286 - Affirm 400 K251286 is a FDA 510(k) cleared neurology medical device. Manufacturer: Digital Surgery Systems, Inc. (D.B.A True Digital Surgery). Cleared Jan 2026. https://www.510kdatabase.net/k251385/ 2026-01-21 monthly 0.8 https://www.510kdatabase.net/og-image/k251385-inqwire-super-stiff-guide-wire-fda-510k.jpg K251385 - InQwire Super Stiff Guide Wire (IQSS32180J3) K251385 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Ireland, Ltd.. Cleared Jan 2026. https://www.510kdatabase.net/k252369/ 2026-01-21 monthly 0.8 https://www.510kdatabase.net/og-image/k252369-boston-pico755-fda-510k.jpg K252369 - Boston Pico755 K252369 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Boston Aesthetics, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k252977/ 2026-01-21 monthly 0.8 https://www.510kdatabase.net/og-image/k252977-halcyon-ethos-radiotherapy-system-50-fda-510k.jpg K252977 - Halcyon, Ethos Radiotherapy System (5.0) K252977 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k253713/ 2026-01-21 monthly 0.8 https://www.510kdatabase.net/og-image/k253713-arthrex-variable-angle-va-proximal-fda-510k.jpg K253713 - Arthrex Variable Angle (VA) Proximal Tibia Plating System K253713 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k253730/ 2026-01-21 monthly 0.8 https://www.510kdatabase.net/og-image/k253730-rovo-mechanical-thrombectomy-system-fda-510k.jpg K253730 - RoVo Mechanical Thrombectomy System K253730 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Verge Medical, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k254165/ 2026-01-21 monthly 0.8 https://www.510kdatabase.net/og-image/k254165-infinity-oct-system-fda-510k.jpg K254165 - Infinity™ OCT System K254165 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k260170/ 2026-01-21 monthly 0.8 https://www.510kdatabase.net/og-image/k260170-lumicera-fda-510k.jpg K260170 - LumiCera K260170 is a FDA 510(k) cleared dental medical device. Manufacturer: Hangzhou SHINING3D Dental Technology Co., Ltd.. Cleared Jan 2026. https://www.510kdatabase.net/k250954/ 2026-01-20 monthly 0.8 https://www.510kdatabase.net/og-image/k250954-drx-evolution-plus-x-ray-system-drx-fda-510k.jpg K250954 - DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detector K250954 is a FDA 510(k) cleared radiology medical device. Manufacturer: Carestream Health. Cleared Jan 2026. https://www.510kdatabase.net/k251318/ 2026-01-20 monthly 0.8 https://www.510kdatabase.net/og-image/k251318-varifuse-adjustable-infusion-catheter-fda-510k.jpg K251318 - VariFuse Adjustable Infusion Catheter K251318 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Argon Medical Devices, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k251338/ 2026-01-20 monthly 0.8 https://www.510kdatabase.net/og-image/k251338-cholangioscope-visualization-system-fda-510k.jpg K251338 - Cholangioscope Visualization System (Single-use Video Cholangioscope: SCV-P-01G, SCV-P-02G K251338 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Scivita Medical Technology Co., Ltd.. Cleared Jan 2026. https://www.510kdatabase.net/k252537/ 2026-01-20 monthly 0.8 https://www.510kdatabase.net/og-image/k252537-rusch-softsimplastic-foley-catheters-fda-510k.jpg K252537 - Rusch SoftSimplastic Foley Catheters K252537 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Teleflex Medical Sdn. Bhd.. Cleared Jan 2026. https://www.510kdatabase.net/k253173/ 2026-01-20 monthly 0.8 https://www.510kdatabase.net/og-image/k253173-uct-780-with-uws-ct-dual-energy-analysis-fda-510k.jpg K253173 - uCT 780 with uWS-CT-Dual Energy Analysis K253173 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Jan 2026. https://www.510kdatabase.net/k253291/ 2026-01-20 monthly 0.8 https://www.510kdatabase.net/og-image/k253291-excelsior-system-fda-510k.jpg K253291 - Excelsior System K253291 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Blue Ocean Global. Cleared Jan 2026. https://www.510kdatabase.net/k253597/ 2026-01-20 monthly 0.8 https://www.510kdatabase.net/og-image/k253597-aplio-beyond-and-aplio-me-software-v20-fda-510k.jpg K253597 - Aplio beyond and Aplio me Software V2.0 Diagnostic Ultrasound System K253597 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Jan 2026. https://www.510kdatabase.net/k253698/ 2026-01-20 monthly 0.8 https://www.510kdatabase.net/og-image/k253698-milex-incontinence-dish-pessaries-fda-510k.jpg K253698 - Milex™ Incontinence Dish Pessaries K253698 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Cooper Surgical. Cleared Jan 2026. https://www.510kdatabase.net/k253998/ 2026-01-20 monthly 0.8 https://www.510kdatabase.net/og-image/k253998-clearview-intracoronary-shunts-fda-510k.jpg K253998 - Clearview Intracoronary Shunts K253998 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k254085/ 2026-01-18 monthly 0.8 https://www.510kdatabase.net/og-image/k254085-carto-3-ep-navigation-system-v90-with-fda-510k.jpg K254085 - CARTO™ 3 EP Navigation System V9.0 with PIU Plus K254085 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biosense Webster, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k254114/ 2026-01-18 monthly 0.8 https://www.510kdatabase.net/og-image/k254114-baylis-connector-cable-fda-510k.jpg K254114 - Baylis Connector Cable K254114 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baylis Medical Technologies, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k251970/ 2026-01-17 monthly 0.8 https://www.510kdatabase.net/og-image/k251970-sprinter-legend-rapid-exchange-balloon-fda-510k.jpg K251970 - Sprinter Legend Rapid Exchange Balloon Dilatation Catheter K251970 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Ireland. Cleared Jan 2026. https://www.510kdatabase.net/k253363/ 2026-01-17 monthly 0.8 https://www.510kdatabase.net/og-image/k253363-neurospan-bridge-fda-510k.jpg K253363 - NeuroSpan Bridge K253363 is a FDA 510(k) cleared neurology medical device. Manufacturer: Auxilium Biotechnologies, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k250135/ 2026-01-16 monthly 0.8 https://www.510kdatabase.net/og-image/k250135-wave-clinical-platform-20000-fda-510k.jpg K250135 - WAVE Clinical Platform (2.0.000) K250135 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp/ Excel Medical. Cleared Jan 2026. https://www.510kdatabase.net/k251249/ 2026-01-16 monthly 0.8 https://www.510kdatabase.net/og-image/k251249-tru-hematology-test-fda-510k.jpg K251249 - Tru Hematology Test K251249 is a FDA 510(k) cleared hematology medical device. Manufacturer: Truvian Sciences, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k251341/ 2026-01-16 monthly 0.8 https://www.510kdatabase.net/og-image/k251341-vital-tubing-sets-for-hemodialysis-fda-510k.jpg K251341 - VITAL Tubing Sets for Hemodialysis K251341 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Vital Healthcare Sdn. Bhd.. Cleared Jan 2026. https://www.510kdatabase.net/k251353/ 2026-01-16 monthly 0.8 https://www.510kdatabase.net/og-image/k251353-eyer-2-fda-510k.jpg K251353 - Eyer 2 K251353 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Phelcom Technologies. Cleared Jan 2026. https://www.510kdatabase.net/k251367/ 2026-01-16 monthly 0.8 https://www.510kdatabase.net/og-image/k251367-optomonitor-3-fda-510k.jpg K251367 - OptoMonitor 3 K251367 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Opsens, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k251448/ 2026-01-16 monthly 0.8 https://www.510kdatabase.net/og-image/k251448-fl-10000u-respiratory-humidifier-fda-510k.jpg K251448 - FL-10000U Respiratory Humidifier K251448 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Flexicare Medical Limited.. Cleared Jan 2026. https://www.510kdatabase.net/k251714/ 2026-01-16 monthly 0.8 https://www.510kdatabase.net/og-image/k251714-ion-c-fda-510k.jpg K251714 - Ion-C K251714 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SurGenTec, LLC. Cleared Jan 2026. https://www.510kdatabase.net/k251721/ 2026-01-16 monthly 0.8 https://www.510kdatabase.net/og-image/k251721-xpert-gi-panel-fda-510k.jpg K251721 - Xpert GI Panel K251721 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Cepheid. Cleared Jan 2026. https://www.510kdatabase.net/k251739/ 2026-01-16 monthly 0.8 https://www.510kdatabase.net/og-image/k251739-da-vinci-surgical-system-is5000-fda-510k.jpg K251739 - da Vinci Surgical System (IS5000) K251739 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k251744/ 2026-01-16 monthly 0.8 https://www.510kdatabase.net/og-image/k251744-affinity-pixie-arterial-filter-with-fda-510k.jpg K251744 - Affinity Pixie™ Arterial Filter with Balance™ Biosurface K251744 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic. Cleared Jan 2026. https://www.510kdatabase.net/k251790/ 2026-01-16 monthly 0.8 https://www.510kdatabase.net/og-image/k251790-septalign-fda-510k.jpg K251790 - SeptAlign K251790 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Spirair, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k251900/ 2026-01-16 monthly 0.8 https://www.510kdatabase.net/og-image/k251900-my01-continuous-compartmental-pressure-fda-510k.jpg K251900 - MY01 Continuous Compartmental Pressure Monitor K251900 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: MY01, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k251934/ 2026-01-16 monthly 0.8 https://www.510kdatabase.net/og-image/k251934-qxr-detect-fda-510k.jpg K251934 - qXR-Detect K251934 is a FDA 510(k) cleared radiology medical device. Manufacturer: Qure.Ai Technologies. Cleared Jan 2026. https://www.510kdatabase.net/k252205/ 2026-01-16 monthly 0.8 https://www.510kdatabase.net/og-image/k252205-curiteva-porous-peek-cervical-fda-510k.jpg K252205 - Curiteva Porous PEEK Cervical Interbody System K252205 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Curiteva, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k252297/ 2026-01-16 monthly 0.8 https://www.510kdatabase.net/og-image/k252297-toro-88-superbore-catheter-fda-510k.jpg K252297 - Toro 88 Superbore Catheter K252297 is a FDA 510(k) cleared neurology medical device. Manufacturer: Toro Neurovascular, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k252634/ 2026-01-16 monthly 0.8 https://www.510kdatabase.net/og-image/k252634-imagine-enterprise-suite-fda-510k.jpg K252634 - Imagine® Enterprise Suite K252634 is a FDA 510(k) cleared radiology medical device. Manufacturer: Softlink International Private Limited. Cleared Jan 2026. https://www.510kdatabase.net/k252767/ 2026-01-16 monthly 0.8 https://www.510kdatabase.net/og-image/k252767-actitens-mini-fda-510k.jpg K252767 - actiTENS mini K252767 is a FDA 510(k) cleared neurology medical device. Manufacturer: Sublimed. Cleared Jan 2026. https://www.510kdatabase.net/k252775/ 2026-01-16 monthly 0.8 https://www.510kdatabase.net/og-image/k252775-noveos-specific-ige-sige-capture-fda-510k.jpg K252775 - NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea) K252775 is a FDA 510(k) cleared immunology medical device. Manufacturer: Hycor Biomedical. Cleared Jan 2026. https://www.510kdatabase.net/k252960/ 2026-01-16 monthly 0.8 https://www.510kdatabase.net/og-image/k252960-solius-pro-uvb-light-panel-fda-510k.jpg K252960 - SOLIUS PRO UVB Light Panel K252960 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Solius Labs, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k253082/ 2026-01-16 monthly 0.8 https://www.510kdatabase.net/og-image/k253082-lzi-buprenorphine-ii-enzyme-immunoassay-fda-510k.jpg K253082 - LZI Buprenorphine II Enzyme Immunoassay K253082 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Lin-Zhi International, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k253408/ 2026-01-16 monthly 0.8 https://www.510kdatabase.net/og-image/k253408-cooltone-fda-510k.jpg K253408 - CoolTone K253408 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zimmer Medizinsysteme GmbH. Cleared Jan 2026. https://www.510kdatabase.net/k253556/ 2026-01-16 monthly 0.8 https://www.510kdatabase.net/og-image/k253556-da-vinci-sp-surgical-system-sp1098-fda-510k.jpg K253556 - da Vinci SP Surgical System (SP1098) K253556 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k254126/ 2026-01-16 monthly 0.8 https://www.510kdatabase.net/og-image/k254126-natrelle-133s-tissue-expanders-fda-510k.jpg K254126 - Natrelle 133S Tissue Expanders K254126 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: AbbVie. Cleared Jan 2026. https://www.510kdatabase.net/k254186/ 2026-01-16 monthly 0.8 https://www.510kdatabase.net/og-image/k254186-azurion-r31-fda-510k.jpg K254186 - Azurion R3.1 K254186 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems B.V.. Cleared Jan 2026. https://www.510kdatabase.net/den250005/ 2026-01-16 monthly 0.8 https://www.510kdatabase.net/og-image/den250005-sana-device-fda-510k.jpg DEN250005 - Sana Device DEN250005 is a FDA 510(k) cleared neurology medical device. Manufacturer: Sana Health. Cleared Jan 2026. https://www.510kdatabase.net/k251254/ 2026-01-15 monthly 0.8 https://www.510kdatabase.net/og-image/k251254-ignite-rf-system-fda-510k.jpg K251254 - Ignite RF System K251254 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Inmode , Ltd.. Cleared Jan 2026. https://www.510kdatabase.net/k251308/ 2026-01-15 monthly 0.8 https://www.510kdatabase.net/og-image/k251308-snuglittm-wearable-phototherapy-system-fda-510k.jpg K251308 - SnugLit(TM) Wearable Phototherapy System (SNGL-01-US) K251308 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Thera B Medical Products. Cleared Jan 2026. https://www.510kdatabase.net/k251357/ 2026-01-15 monthly 0.8 https://www.510kdatabase.net/og-image/k251357-esperance-phlo-aspiration-system-fda-510k.jpg K251357 - Esperance pHLO Aspiration System K251357 is a FDA 510(k) cleared neurology medical device. Manufacturer: Phenox, Ltd.. Cleared Jan 2026. https://www.510kdatabase.net/k251458/ 2026-01-15 monthly 0.8 https://www.510kdatabase.net/og-image/k251458-electric-wheelchair-dh01168-fda-510k.jpg K251458 - Electric Wheelchair (DH01168) K251458 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Foshan Dahao Medical Technology Co., Ltd.. Cleared Jan 2026. https://www.510kdatabase.net/k251831/ 2026-01-15 monthly 0.8 https://www.510kdatabase.net/og-image/k251831-bio-medicus-life-support-catheter-and-fda-510k.jpg K251831 - Bio-Medicus Life Support Catheter and Introducer K251831 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k251847/ 2026-01-15 monthly 0.8 https://www.510kdatabase.net/og-image/k251847-sleepnet-arie-full-face-vented-mask-fda-510k.jpg K251847 - Sleepnet Arie Full Face Vented Mask K251847 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sleepnet Corporation. Cleared Jan 2026. https://www.510kdatabase.net/k251961/ 2026-01-15 monthly 0.8 https://www.510kdatabase.net/og-image/k251961-sds-growing-rod-fda-510k.jpg K251961 - SDS Growing Rod K251961 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: BAAT Medical Products B.V.. Cleared Jan 2026. https://www.510kdatabase.net/k252188/ 2026-01-15 monthly 0.8 https://www.510kdatabase.net/og-image/k252188-emla-elekta-evo-fda-510k.jpg K252188 - EMLA (Elekta Evo) K252188 is a FDA 510(k) cleared radiology medical device. Manufacturer: Elekta Solutions AB. Cleared Jan 2026. https://www.510kdatabase.net/k252283/ 2026-01-15 monthly 0.8 https://www.510kdatabase.net/og-image/k252283-nano-check-influenza-ab-test-fda-510k.jpg K252283 - Nano-Check Influenza A+B Test K252283 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Nano-Ditech Corporation. Cleared Jan 2026. https://www.510kdatabase.net/k252516/ 2026-01-15 monthly 0.8 https://www.510kdatabase.net/og-image/k252516-n22-ez-glenosphere-fda-510k.jpg K252516 - N22 EZ Glenosphere K252516 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Shoulder Innovations, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k252567/ 2026-01-15 monthly 0.8 https://www.510kdatabase.net/og-image/k252567-altivate-reverse-adlc-glenosphere-fda-510k.jpg K252567 - AltiVate Reverse® ADLC Glenosphere K252567 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Encore Medical, L.P.. Cleared Jan 2026. https://www.510kdatabase.net/k252934/ 2026-01-15 monthly 0.8 https://www.510kdatabase.net/og-image/k252934-diagnocat-fda-510k.jpg K252934 - Diagnocat K252934 is a FDA 510(k) cleared radiology medical device. Manufacturer: DGNCT, LLC. Cleared Jan 2026. https://www.510kdatabase.net/k253023/ 2026-01-15 monthly 0.8 https://www.510kdatabase.net/og-image/k253023-biograph-one-fda-510k.jpg K253023 - BIOGRAPH One K253023 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Healthineers AG. Cleared Jan 2026. https://www.510kdatabase.net/k253171/ 2026-01-15 monthly 0.8 https://www.510kdatabase.net/og-image/k253171-libertas-taper-short-ts-uncemented-fda-510k.jpg K253171 - Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem) K253171 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Maxx Orthopedics, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k253276/ 2026-01-15 monthly 0.8 https://www.510kdatabase.net/og-image/k253276-electric-wheelchair-robooter-e80-bbr-fda-510k.jpg K253276 - Electric Wheelchair (Robooter E80) (BBR-E80-01) K253276 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Shanghai Bangbang Robotics Co., Ltd.. Cleared Jan 2026. https://www.510kdatabase.net/k253470/ 2026-01-15 monthly 0.8 https://www.510kdatabase.net/og-image/k253470-minimed-780g-insulin-pump-mmt-1884-fda-510k.jpg K253470 - MiniMed 780G Insulin Pump (MMT-1884) K253470 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Medtronic Minimed, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k253925/ 2026-01-15 monthly 0.8 https://www.510kdatabase.net/og-image/k253925-aventus-thrombectomy-system-fda-510k.jpg K253925 - Aventus Thrombectomy System K253925 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inquis Medical. Cleared Jan 2026. https://www.510kdatabase.net/k254002/ 2026-01-15 monthly 0.8 https://www.510kdatabase.net/og-image/k254002-trimed-volar-bearing-plates-vbeal-13-7s-fda-510k.jpg K254002 - TriMed Volar Bearing Plates (VBEAL-13-7S) K254002 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: TriMed, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k254061/ 2026-01-15 monthly 0.8 https://www.510kdatabase.net/og-image/k254061-curiteva-porous-peek-cervical-fda-510k.jpg K254061 - Curiteva Porous PEEK Cervical Interbody Fusion System K254061 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Curiteva, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/den250009/ 2026-01-15 monthly 0.8 https://www.510kdatabase.net/og-image/den250009-vitasmart-hypothermic-oxygenated-fda-510k.jpg DEN250009 - VitaSmart Hypothermic Oxygenated Perfusion System DEN250009 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Bridge TO Life, Ltd.. Cleared Jan 2026. https://www.510kdatabase.net/k251419/ 2026-01-14 monthly 0.8 https://www.510kdatabase.net/og-image/k251419-laboratorios-biogalenic-sterile-water-fda-510k.jpg K251419 - Laboratorios Biogalenic Sterile Water for Inhalation, USP K251419 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Laboratorios Biogalenic S.A. DE C.V.. Cleared Jan 2026. https://www.510kdatabase.net/k251996/ 2026-01-14 monthly 0.8 https://www.510kdatabase.net/og-image/k251996-entire-ire-system-fda-510k.jpg K251996 - ENTire IRE System K251996 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Entire Medical , Ltd.. Cleared Jan 2026. https://www.510kdatabase.net/k252219/ 2026-01-14 monthly 0.8 https://www.510kdatabase.net/og-image/k252219-cervical-interbody-and-vbr-fusion-system-fda-510k.jpg K252219 - Cervical Interbody and VBR Fusion System K252219 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Sync Surgical. Cleared Jan 2026. https://www.510kdatabase.net/k252313/ 2026-01-14 monthly 0.8 https://www.510kdatabase.net/og-image/k252313-cardinal-health-nitrile-examination-fda-510k.jpg K252313 - Cardinal Health Nitrile Examination Gloves Extended Cuff K252313 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cardinalhealth. Cleared Jan 2026. https://www.510kdatabase.net/k252579/ 2026-01-14 monthly 0.8 https://www.510kdatabase.net/og-image/k252579-orthoscan-tau-mvp-mini-c-arm-system-fda-510k.jpg K252579 - Orthoscan TAU MVP Mini C-Arm System K252579 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ziehm-Orthoscan, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k252958/ 2026-01-14 monthly 0.8 https://www.510kdatabase.net/og-image/k252958-meticuly-patient-specific-titanium-fda-510k.jpg K252958 - METICULY Patient-specific titanium mesh implant K252958 is a FDA 510(k) cleared neurology medical device. Manufacturer: Meticuly Co., Ltd.. Cleared Jan 2026. https://www.510kdatabase.net/k253511/ 2026-01-14 monthly 0.8 https://www.510kdatabase.net/og-image/k253511-concerto-versa-detachable-coil-fda-510k.jpg K253511 - Concerto Versa™ Detachable Coil K253511 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k253585/ 2026-01-14 monthly 0.8 https://www.510kdatabase.net/og-image/k253585-smartguard-technology-fda-510k.jpg K253585 - SmartGuard technology K253585 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Medtronic Minimed, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k254010/ 2026-01-14 monthly 0.8 https://www.510kdatabase.net/og-image/k254010-exactrac-dynamic-202-fda-510k.jpg K254010 - ExacTrac Dynamic (2.0.2) K254010 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab SE. Cleared Jan 2026. https://www.510kdatabase.net/k254190/ 2026-01-14 monthly 0.8 https://www.510kdatabase.net/og-image/k254190-ds-base-15t-fda-510k.jpg K254190 - dS Base 1.5T K254190 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Jan 2026. https://www.510kdatabase.net/k251214/ 2026-01-13 monthly 0.8 https://www.510kdatabase.net/og-image/k251214-bear-bridge-enhanced-acl-restoration-fda-510k.jpg K251214 - BEAR® (Bridge-Enhanced ACL Restoration) Implant K251214 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Miach Orthopaedics, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k252461/ 2026-01-13 monthly 0.8 https://www.510kdatabase.net/og-image/k252461-swedge-pedicle-screw-fixation-system-fda-510k.jpg K252461 - Swedge™ Pedicle Screw Fixation System Bezier Rod K252461 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinal Resources, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k252549/ 2026-01-13 monthly 0.8 https://www.510kdatabase.net/og-image/k252549-non-sterile-powder-free-nitrile-fda-510k.jpg K252549 - Non-sterile Powder Free Nitrile Examination Glove, Dual Color (White-Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Xylazine HCl, and Simulated Gastric Acid K252549 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Kossan International Sdn Bhd. Cleared Jan 2026. https://www.510kdatabase.net/k253248/ 2026-01-13 monthly 0.8 https://www.510kdatabase.net/og-image/k253248-bright-cavity-liner-fda-510k.jpg K253248 - Bright Cavity Liner K253248 is a FDA 510(k) cleared dental medical device. Manufacturer: Dmp Dental Industry S.A.. Cleared Jan 2026. https://www.510kdatabase.net/k254001/ 2026-01-13 monthly 0.8 https://www.510kdatabase.net/og-image/k254001-veriton-ct-300-series-digital-spectct-fda-510k.jpg K254001 - VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364) K254001 is a FDA 510(k) cleared radiology medical device. Manufacturer: Spectrum Dynamics Medical, Ltd.. Cleared Jan 2026. https://www.510kdatabase.net/k254014/ 2026-01-13 monthly 0.8 https://www.510kdatabase.net/og-image/k254014-connected-or-hub-with-device-and-voice-fda-510k.jpg K254014 - Connected OR Hub with Device and Voice Control K254014 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker Endoscopy. Cleared Jan 2026. https://www.510kdatabase.net/k250890/ 2026-01-12 monthly 0.8 https://www.510kdatabase.net/og-image/k250890-sbc1-cream-fda-510k.jpg K250890 - SBC1 Cream K250890 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sioxmed, LLC. Cleared Jan 2026. https://www.510kdatabase.net/k251307/ 2026-01-12 monthly 0.8 https://www.510kdatabase.net/og-image/k251307-clinical-automatic-blood-pressure-fda-510k.jpg K251307 - Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i) K251307 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Hingmed Medical Instrument Co., Ltd.. Cleared Jan 2026. https://www.510kdatabase.net/k251388/ 2026-01-12 monthly 0.8 https://www.510kdatabase.net/og-image/k251388-dental-air-motor-handpiece-tm-203b2-tm-fda-510k.jpg K251388 - Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41) K251388 is a FDA 510(k) cleared dental medical device. Manufacturer: Foshan Topmed Dental Co., Ltd.. Cleared Jan 2026. https://www.510kdatabase.net/k251389/ 2026-01-12 monthly 0.8 https://www.510kdatabase.net/og-image/k251389-high-speed-air-turbine-handpiece-fda-510k.jpg K251389 - High speed air turbine handpiece K251389 is a FDA 510(k) cleared dental medical device. Manufacturer: Foshan Topmed Dental Co., Ltd.. Cleared Jan 2026. https://www.510kdatabase.net/k251524/ 2026-01-12 monthly 0.8 https://www.510kdatabase.net/og-image/k251524-dr-yglo-skin-tag-remover-fda-510k.jpg K251524 - Dr. Yglo Skin Tag Remover K251524 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Theotclab Healthcare B.V.. Cleared Jan 2026. https://www.510kdatabase.net/k251558/ 2026-01-12 monthly 0.8 https://www.510kdatabase.net/og-image/k251558-precision-ai-surgical-planning-system-fda-510k.jpg K251558 - Precision AI Surgical Planning System (PAI-SPS) K251558 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Precision AI Pty, Ltd.. Cleared Jan 2026. https://www.510kdatabase.net/k251701/ 2026-01-12 monthly 0.8 https://www.510kdatabase.net/og-image/k251701-star-e900-electric-system-fda-510k.jpg K251701 - Star E900 Electric System K251701 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentalez, Inc., Stardental Division. Cleared Jan 2026. https://www.510kdatabase.net/k251886/ 2026-01-12 monthly 0.8 https://www.510kdatabase.net/og-image/k251886-empowerride-navigator-fda-510k.jpg K251886 - EmpowerRide NAVIGATOR K251886 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Empower Ride, LLC. Cleared Jan 2026. https://www.510kdatabase.net/k251988/ 2026-01-12 monthly 0.8 https://www.510kdatabase.net/og-image/k251988-boston-iface-boston-iface-fda-510k.jpg K251988 - Boston iFace (Boston iFace) K251988 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Boston Aesthetics, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k252807/ 2026-01-12 monthly 0.8 https://www.510kdatabase.net/og-image/k252807-arthrex-anatomic-lapidus-plates-and-i-fda-510k.jpg K252807 - Arthrex Anatomic Lapidus Plates and I-Beam Lapidus Plates K252807 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k252830/ 2026-01-12 monthly 0.8 https://www.510kdatabase.net/og-image/k252830-disposable-surgical-face-mask-3p00b-fda-510k.jpg K252830 - Disposable Surgical Face Mask (3P00B, C2900) K252830 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Beatles Medical Supplies (Xiantao) Co., Ltd.. Cleared Jan 2026. https://www.510kdatabase.net/k252913/ 2026-01-12 monthly 0.8 https://www.510kdatabase.net/og-image/k252913-break-wave-fda-510k.jpg K252913 - Break Wave K252913 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Sonomotion, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k252962/ 2026-01-12 monthly 0.8 https://www.510kdatabase.net/og-image/k252962-dynamis-navigation-system-fda-510k.jpg K252962 - DYNAMIS™ Navigation System K252962 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Promethean Restorative, LLC. Cleared Jan 2026. https://www.510kdatabase.net/k253167/ 2026-01-12 monthly 0.8 https://www.510kdatabase.net/og-image/k253167-any-paste-fda-510k.jpg K253167 - Any-Paste K253167 is a FDA 510(k) cleared dental medical device. Manufacturer: Mediclus Co., Ltd.. Cleared Jan 2026. https://www.510kdatabase.net/k252842/ 2026-01-11 monthly 0.8 https://www.510kdatabase.net/og-image/k252842-safeop-3-neural-informatix-system-fda-510k.jpg K252842 - SafeOp 3: Neural Informatix System K252842 is a FDA 510(k) cleared neurology medical device. Manufacturer: Alphatec Spine, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k251139/ 2026-01-09 monthly 0.8 https://www.510kdatabase.net/og-image/k251139-kabihelp-uno-fda-510k.jpg K251139 - KabiHelp® Uno K251139 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Fresenius Kabi AG. Cleared Jan 2026. https://www.510kdatabase.net/k251157/ 2026-01-09 monthly 0.8 https://www.510kdatabase.net/og-image/k251157-core-metabolic-fda-510k.jpg K251157 - Core Metabolic K251157 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Truvian Health. Cleared Jan 2026. https://www.510kdatabase.net/k252206/ 2026-01-09 monthly 0.8 https://www.510kdatabase.net/og-image/k252206-nova-allegro-uacr-assay-nova-allegro-fda-510k.jpg K252206 - Nova Allegro UACR Assay, Nova Allegro Analyzer K252206 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Nova Biomedical Corporation. Cleared Jan 2026. https://www.510kdatabase.net/k252339/ 2026-01-09 monthly 0.8 https://www.510kdatabase.net/og-image/k252339-iotasoft-insertion-system-fda-510k.jpg K252339 - iotaSOFT® Insertion System K252339 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Iotamotion, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k252589/ 2026-01-09 monthly 0.8 https://www.510kdatabase.net/og-image/k252589-corvair-monza-fda-510k.jpg K252589 - Corvair Monza K252589 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: AliveCor, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k252674/ 2026-01-09 monthly 0.8 https://www.510kdatabase.net/og-image/k252674-solo-pace-fusion-system-solofuse1-fda-510k.jpg K252674 - Solo Pace Fusion System (SOLOFUSE1) K252674 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Solo Pace, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k252847/ 2026-01-09 monthly 0.8 https://www.510kdatabase.net/og-image/k252847-nextar-hip-platform-fda-510k.jpg K252847 - NextAR Hip Platform K252847 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Jan 2026. https://www.510kdatabase.net/k252906/ 2026-01-09 monthly 0.8 https://www.510kdatabase.net/og-image/k252906-echelon-endopath-staple-line-fda-510k.jpg K252906 - ECHELON ENDOPATH Staple Line Reinforcement (ECH60R) K252906 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon Endo-Surgery, LLC. Cleared Jan 2026. https://www.510kdatabase.net/k253075/ 2026-01-09 monthly 0.8 https://www.510kdatabase.net/og-image/k253075-mobility-scooter-air-classic-fda-510k.jpg K253075 - Mobility scooter (Air Classic) K253075 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.. Cleared Jan 2026. https://www.510kdatabase.net/k253142/ 2026-01-09 monthly 0.8 https://www.510kdatabase.net/og-image/k253142-arm-blood-pressure-monitor-fda-510k.jpg K253142 - Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,RN3D,MJ4D,RN1D,RN2D) K253142 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ningbo Ranor Medical Technology Co., Ltd.. Cleared Jan 2026. https://www.510kdatabase.net/k253550/ 2026-01-09 monthly 0.8 https://www.510kdatabase.net/og-image/k253550-self-forming-magnet-flexagon-plus-otoloc-fda-510k.jpg K253550 - Self-Forming Magnet (Flexagon Plus OTOLoc) K253550 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: GI Windows, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k253957/ 2026-01-09 monthly 0.8 https://www.510kdatabase.net/og-image/k253957-hemosil-silica-clotting-time-fda-510k.jpg K253957 - HemosIL Silica Clotting Time K253957 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory (IL) Co.. Cleared Jan 2026. https://www.510kdatabase.net/k253964/ 2026-01-09 monthly 0.8 https://www.510kdatabase.net/og-image/k253964-disposable-neonatal-nibp-cuff-u1681s-fda-510k.jpg K253964 - Disposable Neonatal NIBP Cuff (U1681S-C51N) K253964 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Unimed Medical Supplies, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k253973/ 2026-01-09 monthly 0.8 https://www.510kdatabase.net/og-image/k253973-gradual-dental-zirconia-blank-gtf-p1-fda-510k.jpg K253973 - Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series K253973 is a FDA 510(k) cleared dental medical device. Manufacturer: Liaoning Upcera Co., Ltd.. Cleared Jan 2026. https://www.510kdatabase.net/k254003/ 2026-01-09 monthly 0.8 https://www.510kdatabase.net/og-image/k254003-jarvis-metaphyseal-stem-fda-510k.jpg K254003 - JARVIS Metaphyseal Stem K254003 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: FH Industrie. Cleared Jan 2026. https://www.510kdatabase.net/k251160/ 2026-01-08 monthly 0.8 https://www.510kdatabase.net/og-image/k251160-sterile-temperature-probe-model-fda-510k.jpg K251160 - Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS) K251160 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen Med-Link Electronics Tech Co., Ltd.. Cleared Jan 2026. https://www.510kdatabase.net/k252585/ 2026-01-08 monthly 0.8 https://www.510kdatabase.net/og-image/k252585-zenex-implant-systemr-system-fda-510k.jpg K252585 - ZENEX Implant System_R-System K252585 is a FDA 510(k) cleared dental medical device. Manufacturer: Izenimplant Co., Ltd.. Cleared Jan 2026. https://www.510kdatabase.net/k252669/ 2026-01-08 monthly 0.8 https://www.510kdatabase.net/og-image/k252669-fetal-doppler-u8-25-u9-25-fda-510k.jpg K252669 - Fetal Doppler U8-25, U9-25 K252669 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Zhongshan Xiaolan Town Senlan Electronic Factory. Cleared Jan 2026. https://www.510kdatabase.net/k252711/ 2026-01-08 monthly 0.8 https://www.510kdatabase.net/og-image/k252711-advantage-c-ti3d-cervical-interbody-fda-510k.jpg K252711 - Advantage-C™ Ti3D Cervical Interbody Fusion Device K252711 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Intelivation Technologies. Cleared Jan 2026. https://www.510kdatabase.net/k252759/ 2026-01-08 monthly 0.8 https://www.510kdatabase.net/og-image/k252759-revyve-antimicrobial-skin-and-wound-fda-510k.jpg K252759 - revyve® Antimicrobial Skin and Wound Cleanser K252759 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Kane Biotech, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k252788/ 2026-01-08 monthly 0.8 https://www.510kdatabase.net/og-image/k252788-tornier-perform-reversed-monopost-fda-510k.jpg K252788 - Tornier Perform™ Reversed Monopost Glenoid (Perform Mono) K252788 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tornier, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k252794/ 2026-01-08 monthly 0.8 https://www.510kdatabase.net/og-image/k252794-vision-mr-diagnostic-catheter-fda-510k.jpg K252794 - Vision-MR™ Diagnostic Catheter K252794 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Imricor Medical Systems, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k253266/ 2026-01-08 monthly 0.8 https://www.510kdatabase.net/og-image/k253266-titanium-interbody-system-fda-510k.jpg K253266 - Titanium Interbody System K253266 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spine Innovation, LLC. Cleared Jan 2026. https://www.510kdatabase.net/k253370/ 2026-01-08 monthly 0.8 https://www.510kdatabase.net/og-image/k253370-logiq-totus-fda-510k.jpg K253370 - LOGIQ Totus K253370 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared Jan 2026. https://www.510kdatabase.net/k253512/ 2026-01-08 monthly 0.8 https://www.510kdatabase.net/og-image/k253512-minimed-go-app-fda-510k.jpg K253512 - MiniMed Go App K253512 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Medtronic Minimed. Cleared Jan 2026. https://www.510kdatabase.net/k253639/ 2026-01-08 monthly 0.8 https://www.510kdatabase.net/og-image/k253639-view-fda-510k.jpg K253639 - View K253639 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Jan 2026. https://www.510kdatabase.net/k253784/ 2026-01-08 monthly 0.8 https://www.510kdatabase.net/og-image/k253784-3dicom-md-cloud-fda-510k.jpg K253784 - 3DICOM MD Cloud K253784 is a FDA 510(k) cleared radiology medical device. Manufacturer: Singular Health Pty, Ltd.. Cleared Jan 2026. https://www.510kdatabase.net/k250305/ 2026-01-07 monthly 0.8 https://www.510kdatabase.net/og-image/k250305-reprocessed-agilis-nxt-steerable-fda-510k.jpg K250305 - Reprocessed Agilis NxT Steerable Introducer K250305 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Innovative Health. Cleared Jan 2026. https://www.510kdatabase.net/k251207/ 2026-01-07 monthly 0.8 https://www.510kdatabase.net/og-image/k251207-sangria-thrombectomy-system-fda-510k.jpg K251207 - Sangria™ Thrombectomy System K251207 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Avantec Vascular Corporation. Cleared Jan 2026. https://www.510kdatabase.net/k251454/ 2026-01-07 monthly 0.8 https://www.510kdatabase.net/og-image/k251454-clear-aligner-scf-3348-fda-510k.jpg K251454 - Clear Aligner (SCF-3348) K251454 is a FDA 510(k) cleared dental medical device. Manufacturer: Beame Medical Technology (Shenzhen) Limited. Cleared Jan 2026. https://www.510kdatabase.net/k252507/ 2026-01-07 monthly 0.8 https://www.510kdatabase.net/og-image/k252507-smileinspector-fda-510k.jpg K252507 - SmileInspector K252507 is a FDA 510(k) cleared dental medical device. Manufacturer: Amv Consulting, LLC. Cleared Jan 2026. https://www.510kdatabase.net/k252727/ 2026-01-07 monthly 0.8 https://www.510kdatabase.net/og-image/k252727-neodent-inlab-validated-workflow-fda-510k.jpg K252727 - Neodent InLab Validated Workflow K252727 is a FDA 510(k) cleared dental medical device. Manufacturer: JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A.. Cleared Jan 2026. https://www.510kdatabase.net/k252890/ 2026-01-07 monthly 0.8 https://www.510kdatabase.net/og-image/k252890-zenseal-pro-fda-510k.jpg K252890 - ZenSeal Pro K252890 is a FDA 510(k) cleared dental medical device. Manufacturer: Kerr Corporation. Cleared Jan 2026. https://www.510kdatabase.net/k252970/ 2026-01-07 monthly 0.8 https://www.510kdatabase.net/og-image/k252970-briefcase-triage-care-multi-triage-ct-fda-510k.jpg K252970 - BriefCase-Triage: CARE Multi-triage CT Body K252970 is a FDA 510(k) cleared radiology medical device. Manufacturer: Aidoc Medical , Ltd.. Cleared Jan 2026. https://www.510kdatabase.net/k253009/ 2026-01-07 monthly 0.8 https://www.510kdatabase.net/og-image/k253009-ds-core-detect-fda-510k.jpg K253009 - DS Core Detect K253009 is a FDA 510(k) cleared radiology medical device. Manufacturer: Dentsply Sirona, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k253109/ 2026-01-07 monthly 0.8 https://www.510kdatabase.net/og-image/k253109-reusable-spo2-sensor-bsa307-47-fda-510k.jpg K253109 - Reusable SPO2 Sensor (BSA307-47 K253109 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Best Electronics Co., Ltd.. Cleared Jan 2026. https://www.510kdatabase.net/k253158/ 2026-01-07 monthly 0.8 https://www.510kdatabase.net/og-image/k253158-vybrate-vbr-system-fda-510k.jpg K253158 - VyBrate™ VBR System K253158 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Vy Spine, LLC. Cleared Jan 2026. https://www.510kdatabase.net/k253308/ 2026-01-07 monthly 0.8 https://www.510kdatabase.net/og-image/k253308-materialise-personalized-guides-and-fda-510k.jpg K253308 - Materialise Personalized Guides and Models for Craniomaxillofacial Surgery CMF Titanium Guides K253308 is a FDA 510(k) cleared neurology medical device. Manufacturer: Materialise NV. Cleared Jan 2026. https://www.510kdatabase.net/k253366/ 2026-01-07 monthly 0.8 https://www.510kdatabase.net/og-image/k253366-logiq-fortis-fda-510k.jpg K253366 - LOGIQ Fortis K253366 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared Jan 2026. https://www.510kdatabase.net/k253923/ 2026-01-07 monthly 0.8 https://www.510kdatabase.net/og-image/k253923-purastat-fda-510k.jpg K253923 - PuraStat K253923 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: 3-D Matrix Europe SAS. Cleared Jan 2026. https://www.510kdatabase.net/k253924/ 2026-01-07 monthly 0.8 https://www.510kdatabase.net/og-image/k253924-purastat-fda-510k.jpg K253924 - PuraStat K253924 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3-D Matrix Europe SAS. Cleared Jan 2026. https://www.510kdatabase.net/k253939/ 2026-01-07 monthly 0.8 https://www.510kdatabase.net/og-image/k253939-deltawave-nasal-pillow-system-fda-510k.jpg K253939 - DeltaWave Nasal Pillow System K253939 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: RemSleep Holdings, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k253941/ 2026-01-07 monthly 0.8 https://www.510kdatabase.net/og-image/k253941-cd-horizon-modulex-spinal-system-fda-510k.jpg K253941 - CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly) K253941 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k253990/ 2026-01-07 monthly 0.8 https://www.510kdatabase.net/og-image/k253990-kheiron-spinal-fixation-system-fda-510k.jpg K253990 - KHEIRON® Spinal Fixation System, including patient specific K-ROD K253990 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: S.M.A.I.O. Cleared Jan 2026. https://www.510kdatabase.net/k250341/ 2026-01-06 monthly 0.8 https://www.510kdatabase.net/og-image/k250341-sensilift-pro-st300xxyyzzz-fda-510k.jpg K250341 - Sensilift Pro (ST300XXYYZZZ) K250341 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: El Global Trade, Ltd.. Cleared Jan 2026. https://www.510kdatabase.net/k251097/ 2026-01-06 monthly 0.8 https://www.510kdatabase.net/og-image/k251097-v-dac-catheter-fda-510k.jpg K251097 - V-DAC Catheter K251097 is a FDA 510(k) cleared neurology medical device. Manufacturer: Vesalio, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k251165/ 2026-01-06 monthly 0.8 https://www.510kdatabase.net/og-image/k251165-saans-f4-01-00-000-000-fda-510k.jpg K251165 - Saans (F4-01-00-000-000) K251165 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Innaccel Technologies Private Limited. Cleared Jan 2026. https://www.510kdatabase.net/k252749/ 2026-01-06 monthly 0.8 https://www.510kdatabase.net/og-image/k252749-medconn-8k-glycated-hemoglobin-test-fda-510k.jpg K252749 - Medconn 8K Glycated Hemoglobin Test System K252749 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Shanghai Medconn Medical Technology Co., Ltd.. Cleared Jan 2026. https://www.510kdatabase.net/k252886/ 2026-01-06 monthly 0.8 https://www.510kdatabase.net/og-image/k252886-pen-needle-fda-510k.jpg K252886 - Pen Needle K252886 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hh Global Technology, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k252894/ 2026-01-06 monthly 0.8 https://www.510kdatabase.net/og-image/k252894-aprevo-cervical-interbody-system-fda-510k.jpg K252894 - aprevo® cervical interbody system K252894 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Carlsmed, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k253178/ 2026-01-06 monthly 0.8 https://www.510kdatabase.net/og-image/k253178-trileap-plating-system-fda-510k.jpg K253178 - TRILEAP Plating System K253178 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Crossroads Extremity Systems. Cleared Jan 2026. https://www.510kdatabase.net/k253618/ 2026-01-06 monthly 0.8 https://www.510kdatabase.net/og-image/k253618-quadlock-fixation-system-fda-510k.jpg K253618 - QuadLock™ Fixation System K253618 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Abanza Tecnomed S.L. Cleared Jan 2026. https://www.510kdatabase.net/k253793/ 2026-01-06 monthly 0.8 https://www.510kdatabase.net/og-image/k253793-materialise-tka-guide-system-fda-510k.jpg K253793 - Materialise TKA Guide System K253793 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Materialise NV. Cleared Jan 2026. https://www.510kdatabase.net/k251630/ 2026-01-05 monthly 0.8 https://www.510kdatabase.net/og-image/k251630-atellica-im-total-psa-ii-tpsaii-fda-510k.jpg K251630 - Atellica IM Total PSA II (tPSAII) K251630 is a FDA 510(k) cleared immunology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k251668/ 2026-01-05 monthly 0.8 https://www.510kdatabase.net/og-image/k251668-surfrider-13-microcatheter-fda-510k.jpg K251668 - SurfRider 13 Microcatheter K251668 is a FDA 510(k) cleared neurology medical device. Manufacturer: Kaneka Americas Holding, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k251757/ 2026-01-05 monthly 0.8 https://www.510kdatabase.net/og-image/k251757-puracyn-plus-antimicrobial-irrigation-fda-510k.jpg K251757 - Puracyn® Plus Antimicrobial Irrigation Solution K251757 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Innovacyn, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k252018/ 2026-01-05 monthly 0.8 https://www.510kdatabase.net/og-image/k252018-hera-z20-diagnostic-ultrasound-system-fda-510k.jpg K252018 - HERA Z20 Diagnostic Ultrasound System K252018 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Medison Co., Ltd.. Cleared Jan 2026. https://www.510kdatabase.net/k252650/ 2026-01-05 monthly 0.8 https://www.510kdatabase.net/og-image/k252650-disposable-medical-face-mask-fda-510k.jpg K252650 - Disposable Medical Face Mask K252650 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Makrite Industries, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k252988/ 2026-01-05 monthly 0.8 https://www.510kdatabase.net/og-image/k252988-chartcheck-radch-v16-fda-510k.jpg K252988 - ChartCheck (RADCH V1.6) K252988 is a FDA 510(k) cleared radiology medical device. Manufacturer: Radformation, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k253008/ 2026-01-05 monthly 0.8 https://www.510kdatabase.net/og-image/k253008-mailink-fda-510k.jpg K253008 - maiLink K253008 is a FDA 510(k) cleared radiology medical device. Manufacturer: Maihub Corp.. Cleared Jan 2026. https://www.510kdatabase.net/k251178/ 2026-01-02 monthly 0.8 https://www.510kdatabase.net/og-image/k251178-ready-to-use-nelaton-catheter-fda-510k.jpg K251178 - Ready to use Nelaton Catheter K251178 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Jamjoom Fullcare Corporation. Cleared Jan 2026. https://www.510kdatabase.net/k252817/ 2026-01-02 monthly 0.8 https://www.510kdatabase.net/og-image/k252817-mobility-scooter-bc-ms310-fda-510k.jpg K252817 - Mobility Scooter (BC-MS310) K252817 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Ningbo Baichen Medical Devices Co., Ltd.. Cleared Jan 2026. https://www.510kdatabase.net/k253854/ 2026-01-02 monthly 0.8 https://www.510kdatabase.net/og-image/k253854-montage-xt-cranial-cement-fda-510k.jpg K253854 - MONTAGE XT Cranial Cement K253854 is a FDA 510(k) cleared neurology medical device. Manufacturer: Orthocon, Inc.. Cleared Jan 2026. https://www.510kdatabase.net/k253867/ 2026-01-02 monthly 0.8 https://www.510kdatabase.net/og-image/k253867-fiberlocker-implant-fda-510k.jpg K253867 - FiberLocker Implant K253867 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: ZuriMED Technologies AG. Cleared Jan 2026. https://www.510kdatabase.net/k243627/ 2025-12-31 monthly 0.8 https://www.510kdatabase.net/og-image/k243627-laryngoscope-junctional-arterial-fda-510k.jpg K243627 - Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC) K243627 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Arc Trauma, LLC. Cleared Dec 2025. https://www.510kdatabase.net/k252901/ 2025-12-31 monthly 0.8 https://www.510kdatabase.net/og-image/k252901-tyber-medical-trauma-screw-fda-510k.jpg K252901 - Tyber Medical Trauma Screw K252901 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tyber Medical, LLC. Cleared Dec 2025. https://www.510kdatabase.net/k252951/ 2025-12-31 monthly 0.8 https://www.510kdatabase.net/og-image/k252951-genesis-sleep-fda-510k.jpg K252951 - Genesis Sleep K252951 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neurofield, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k253305/ 2025-12-31 monthly 0.8 https://www.510kdatabase.net/og-image/k253305-tens-and-ems-tens-and-muscle-fda-510k.jpg K253305 - TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034) K253305 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Jiantuo Electronics Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k253888/ 2025-12-31 monthly 0.8 https://www.510kdatabase.net/og-image/k253888-molli-2-system-fda-510k.jpg K253888 - MOLLI 2 System K253888 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker Endoscopy. Cleared Dec 2025. https://www.510kdatabase.net/k242492/ 2025-12-30 monthly 0.8 https://www.510kdatabase.net/og-image/k242492-multichem-id-g-09339892190-fda-510k.jpg K242492 - Multichem ID-G (09339892190) K242492 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Techno-Path Manufacturing , Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k250168/ 2025-12-30 monthly 0.8 https://www.510kdatabase.net/og-image/k250168-life-ultra-25l-tabletop-mono-chamber-fda-510k.jpg K250168 - Life Ultra 25L Tabletop Mono Chamber Steam Sterilizer K250168 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Lucas Lifecare. Cleared Dec 2025. https://www.510kdatabase.net/k251091/ 2025-12-30 monthly 0.8 https://www.510kdatabase.net/og-image/k251091-lipids-fda-510k.jpg K251091 - Lipids K251091 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Truvian Health. Cleared Dec 2025. https://www.510kdatabase.net/k253532/ 2025-12-30 monthly 0.8 https://www.510kdatabase.net/og-image/k253532-truspect-processing-station-fda-510k.jpg K253532 - TruSPECT Processing Station K253532 is a FDA 510(k) cleared radiology medical device. Manufacturer: Spectrum Dynamics Medical, Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k253844/ 2025-12-30 monthly 0.8 https://www.510kdatabase.net/og-image/k253844-anyscan-30-nm-scanner-family-fda-510k.jpg K253844 - AnyScan 3.0 NM Scanner Family K253844 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mediso Medical Imaging Systems, Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k253895/ 2025-12-30 monthly 0.8 https://www.510kdatabase.net/og-image/k253895-arthrex-swivelock-suture-anchor-35-x-fda-510k.jpg K253895 - Arthrex SwiveLock Suture Anchor, 3.5 x 10 mm K253895 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k251025/ 2025-12-29 monthly 0.8 https://www.510kdatabase.net/og-image/k251025-mon-a-therm-esophageal-stethoscope-fda-510k.jpg K251025 - Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049) K251025 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Covidien, LLC. Cleared Dec 2025. https://www.510kdatabase.net/k251123/ 2025-12-29 monthly 0.8 https://www.510kdatabase.net/og-image/k251123-niti-s-biliary-stent-fda-510k.jpg K251123 - Niti-S Biliary Stent K251123 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Taewoong Medical Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k251313/ 2025-12-29 monthly 0.8 https://www.510kdatabase.net/og-image/k251313-shiley-adult-flexible-tracheostomy-fda-510k.jpg K251313 - Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with Disposable Inner Cannula K251313 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Covidien, LLC. Cleared Dec 2025. https://www.510kdatabase.net/k251534/ 2025-12-29 monthly 0.8 https://www.510kdatabase.net/og-image/k251534-oxygen-concentrator-j10a-fda-510k.jpg K251534 - Oxygen Concentrator (J10A) K251534 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Foshan Kycare Medical Equipment Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k253325/ 2025-12-29 monthly 0.8 https://www.510kdatabase.net/og-image/k253325-ziptoe-hammertoe-fusion-system-fda-510k.jpg K253325 - ZipToe™ Hammertoe Fusion System K253325 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Toetal Solutions. Cleared Dec 2025. https://www.510kdatabase.net/k253343/ 2025-12-29 monthly 0.8 https://www.510kdatabase.net/og-image/k253343-celebrace-software-fda-510k.jpg K253343 - Celebrace Software K253343 is a FDA 510(k) cleared dental medical device. Manufacturer: Celebrace. Cleared Dec 2025. https://www.510kdatabase.net/k253881/ 2025-12-29 monthly 0.8 https://www.510kdatabase.net/og-image/k253881-intense-pulsed-light-ipl-system-models-fda-510k.jpg K253881 - Intense Pulsed Light (IPL) System (Models: T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T505KQ, T505KH, T505KF, SL-B505WM) K253881 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Fansizhe Science And Technology Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k253279/ 2025-12-24 monthly 0.8 https://www.510kdatabase.net/og-image/k253279-feathernumiere-05-06-07-05-fda-510k.jpg K253279 - Feather/numiere 05 06 07 (05) K253279 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Heat IN A Click, LLC. Cleared Dec 2025. https://www.510kdatabase.net/k253342/ 2025-12-24 monthly 0.8 https://www.510kdatabase.net/og-image/k253342-pico-k-fda-510k.jpg K253342 - PICO-K K253342 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Speclipse, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k253349/ 2025-12-24 monthly 0.8 https://www.510kdatabase.net/og-image/k253349-hair-regrowth-cap-model-t-119-hrc-fda-510k.jpg K253349 - Hair Regrowth Cap (Model: T-119-HRC) K253349 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Light Tree Ventures Europe B.V.. Cleared Dec 2025. https://www.510kdatabase.net/k253400/ 2025-12-24 monthly 0.8 https://www.510kdatabase.net/og-image/k253400-led-light-therapy-face-mask-fm60x-fda-510k.jpg K253400 - LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W) K253400 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Saidi Light Therapy Technology Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k250476/ 2025-12-23 monthly 0.8 https://www.510kdatabase.net/og-image/k250476-nizplant-dental-implant-system-fda-510k.jpg K250476 - NizPlant Dental Implant System K250476 is a FDA 510(k) cleared dental medical device. Manufacturer: Paragon Implant Mfg., LLC. Cleared Dec 2025. https://www.510kdatabase.net/k251268/ 2025-12-23 monthly 0.8 https://www.510kdatabase.net/og-image/k251268-diagnostic-ultrasound-system-nano-c5-fda-510k.jpg K251268 - Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP) K251268 is a FDA 510(k) cleared radiology medical device. Manufacturer: Edan Instruments, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k251683/ 2025-12-23 monthly 0.8 https://www.510kdatabase.net/og-image/k251683-deseyne-vifilcon-c-daily-disposable-fda-510k.jpg K251683 - Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Presbyopia (EDOF) K251683 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Bruno Vision Care, LLC. Cleared Dec 2025. https://www.510kdatabase.net/k251800/ 2025-12-23 monthly 0.8 https://www.510kdatabase.net/og-image/k251800-healgen-urs-test-strips-fda-510k.jpg K251800 - Healgen® URS Test Strips K251800 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Healgen Scientific, LLC. Cleared Dec 2025. https://www.510kdatabase.net/k251958/ 2025-12-23 monthly 0.8 https://www.510kdatabase.net/og-image/k251958-veinoplus-back-fda-510k.jpg K251958 - VEINOPLUS Back K251958 is a FDA 510(k) cleared neurology medical device. Manufacturer: Dynapulse Medical. Cleared Dec 2025. https://www.510kdatabase.net/k251978/ 2025-12-23 monthly 0.8 https://www.510kdatabase.net/og-image/k251978-liaison-nes-flu-ab-rsv-covid-19-fda-510k.jpg K251978 - LIAISON NES FLU A/B, RSV & COVID-19 K251978 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Diasorin Molecular, LLC. Cleared Dec 2025. https://www.510kdatabase.net/k251991/ 2025-12-23 monthly 0.8 https://www.510kdatabase.net/og-image/k251991-safesecure-steam-sterilization-process-fda-510k.jpg K251991 - SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016) K251991 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k252145/ 2025-12-23 monthly 0.8 https://www.510kdatabase.net/og-image/k252145-gen5-and-gen5-33mmd-dental-implants-fda-510k.jpg K252145 - GEN5™ and GEN5+™ 3.3mmD Dental Implants K252145 is a FDA 510(k) cleared dental medical device. Manufacturer: Paragon Implant Mfg., LLC. Cleared Dec 2025. https://www.510kdatabase.net/k252146/ 2025-12-23 monthly 0.8 https://www.510kdatabase.net/og-image/k252146-multi-functional-facial-beauty-device-fda-510k.jpg K252146 - Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) K252146 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Siken 3D Technology Development Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k252187/ 2025-12-23 monthly 0.8 https://www.510kdatabase.net/og-image/k252187-aura-glide-fc40-fda-510k.jpg K252187 - Aura Glide (FC40) K252187 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aura Medical, LLC. Cleared Dec 2025. https://www.510kdatabase.net/k252379/ 2025-12-23 monthly 0.8 https://www.510kdatabase.net/og-image/k252379-air-recon-dl-fda-510k.jpg K252379 - AIR Recon DL K252379 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems, LLC. Cleared Dec 2025. https://www.510kdatabase.net/k252493/ 2025-12-23 monthly 0.8 https://www.510kdatabase.net/og-image/k252493-noveos-specific-ige-sige-fda-510k.jpg K252493 - NOVEOS Specific IgE (sIgE) K252493 is a FDA 510(k) cleared immunology medical device. Manufacturer: Hycor Biomedical. Cleared Dec 2025. https://www.510kdatabase.net/k252633/ 2025-12-23 monthly 0.8 https://www.510kdatabase.net/og-image/k252633-unity-dx-udx-fda-510k.jpg K252633 - UNITY DX (UDX) K252633 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Cylite Pty. , Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k252835/ 2025-12-23 monthly 0.8 https://www.510kdatabase.net/og-image/k252835-electric-scooter-s202572j-s2060-m2089-fda-510k.jpg K252835 - Electric Scooter (S202572J, S2060, M2089, S2050) K252835 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Guangdong Prestige Technology Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k253072/ 2025-12-23 monthly 0.8 https://www.510kdatabase.net/og-image/k253072-paruu-wearable-breast-pump-p16-p16-a-fda-510k.jpg K253072 - Paruu Wearable Breast pump (P16, P16-A, P16-B, P16-C, P16-D, P20, P9, P10, P10 PRO, P21, P22, P23, P24, P25, P26, P27, P28, P29, P30, P20-A, P20-B, P20-C, P20-D) K253072 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Linhejiacheng (Shenzhen) E-Commerce Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k253091/ 2025-12-23 monthly 0.8 https://www.510kdatabase.net/og-image/k253091-art-plan-v310-fda-510k.jpg K253091 - ART-Plan+ (v3.1.0) K253091 is a FDA 510(k) cleared radiology medical device. Manufacturer: Therapanacea Sas. Cleared Dec 2025. https://www.510kdatabase.net/k253122/ 2025-12-23 monthly 0.8 https://www.510kdatabase.net/og-image/k253122-simsize-fda-510k.jpg K253122 - Sim&Size K253122 is a FDA 510(k) cleared neurology medical device. Manufacturer: Sim&Cure. Cleared Dec 2025. https://www.510kdatabase.net/k253135/ 2025-12-23 monthly 0.8 https://www.510kdatabase.net/og-image/k253135-led-light-therapy-device-hlgmz-3w-fda-510k.jpg K253135 - LED Light Therapy Device (HLGMZ-3W-G1V1,HLGMZ-3W-G2V1,HLG-GJXJ-G1V1,HGMZ-2W-G1V1, HGMZ-2W-G2V1,MRD-GJXJ-G1V1.) K253135 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Dongguan Yijiaming Technology Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k253217/ 2025-12-23 monthly 0.8 https://www.510kdatabase.net/og-image/k253217-miis-horus-arthroscope-eja-100-fda-510k.jpg K253217 - MiiS Horus Arthroscope (EJA 100) K253217 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medimaging Integrated Solution, Inc (Miis). Cleared Dec 2025. https://www.510kdatabase.net/k253239/ 2025-12-23 monthly 0.8 https://www.510kdatabase.net/og-image/k253239-active-v-total-knee-system-fda-510k.jpg K253239 - Active-V Total Knee System K253239 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Signature Orthopaedics Pty, Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k253281/ 2025-12-23 monthly 0.8 https://www.510kdatabase.net/og-image/k253281-updoc-fda-510k.jpg K253281 - UpDoc K253281 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Updoc, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k253312/ 2025-12-23 monthly 0.8 https://www.510kdatabase.net/og-image/k253312-orangecad-med-abutments-fda-510k.jpg K253312 - OrangeCAD Med Abutments K253312 is a FDA 510(k) cleared dental medical device. Manufacturer: Orangecad Med GmbH. Cleared Dec 2025. https://www.510kdatabase.net/k253341/ 2025-12-23 monthly 0.8 https://www.510kdatabase.net/og-image/k253341-custom-abutments-as-fda-510k.jpg K253341 - Custom Abutments AS K253341 is a FDA 510(k) cleared dental medical device. Manufacturer: Medentika GmbH. Cleared Dec 2025. https://www.510kdatabase.net/k253567/ 2025-12-23 monthly 0.8 https://www.510kdatabase.net/og-image/k253567-healgen-accurate-urine-drug-screen-dip-fda-510k.jpg K253567 - Healgen Accurate Urine Drug Screen Dip Card K253567 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Healgen Scientific, LLC. Cleared Dec 2025. https://www.510kdatabase.net/k253675/ 2025-12-23 monthly 0.8 https://www.510kdatabase.net/og-image/k253675-osteoremedies-hip-spacer-system-fda-510k.jpg K253675 - OsteoRemedies Hip Spacer System K253675 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteoremedies, LLC. Cleared Dec 2025. https://www.510kdatabase.net/k253740/ 2025-12-23 monthly 0.8 https://www.510kdatabase.net/og-image/k253740-tensems-hz9151b-hz9151c-hz9151d-fda-510k.jpg K253740 - TENS&EMS (HZ9151B, HZ9151C, HZ9151D) K253740 is a FDA 510(k) cleared neurology medical device. Manufacturer: Hong Qiangxing (Shenzhen) Electronics Limited. Cleared Dec 2025. https://www.510kdatabase.net/k253754/ 2025-12-23 monthly 0.8 https://www.510kdatabase.net/og-image/k253754-philips-lumea-ipl-fda-510k.jpg K253754 - Philips Lumea IPL K253754 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Philips Consumer Lifestyle B.V.. Cleared Dec 2025. https://www.510kdatabase.net/k254163/ 2025-12-23 monthly 0.8 https://www.510kdatabase.net/og-image/k254163-variosurg-4-fda-510k.jpg K254163 - VarioSurg 4 K254163 is a FDA 510(k) cleared dental medical device. Manufacturer: Nakanishi, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/den250004/ 2025-12-23 monthly 0.8 https://www.510kdatabase.net/og-image/den250004-qikcap-system-fda-510k.jpg DEN250004 - QIKCAP System DEN250004 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hai Solutions. Cleared Dec 2025. https://www.510kdatabase.net/den250032/ 2025-12-23 monthly 0.8 https://www.510kdatabase.net/og-image/den250032-liaison-xl-murex-anti-hdv-318260-fda-510k.jpg DEN250032 - LIAISON® XL MUREX Anti-HDV (318260) DEN250032 is a FDA 510(k) cleared microbiology medical device. Manufacturer: DiaSorin, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k243342/ 2025-12-22 monthly 0.8 https://www.510kdatabase.net/og-image/k243342-kp-protective-face-mask-fda-510k.jpg K243342 - KP Protective Face Mask K243342 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Kp Trading Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k250756/ 2025-12-22 monthly 0.8 https://www.510kdatabase.net/og-image/k250756-pression-wave-pro-external-counter-fda-510k.jpg K250756 - Pression Wave PRO External Counter-Pulsation System K250756 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Pression, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k250959/ 2025-12-22 monthly 0.8 https://www.510kdatabase.net/og-image/k250959-bioticsai-fda-510k.jpg K250959 - BioticsAI K250959 is a FDA 510(k) cleared radiology medical device. Manufacturer: Bioticsai, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k251019/ 2025-12-22 monthly 0.8 https://www.510kdatabase.net/og-image/k251019-bioteq-drainage-catheter-set-bt-pd1-fda-510k.jpg K251019 - BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G K251019 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Bioteque Corporation. Cleared Dec 2025. https://www.510kdatabase.net/k251105/ 2025-12-22 monthly 0.8 https://www.510kdatabase.net/og-image/k251105-tetra-tm-20-fda-510k.jpg K251105 - Tetra (TM-20) K251105 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Emed Technologies Corporation. Cleared Dec 2025. https://www.510kdatabase.net/k251159/ 2025-12-22 monthly 0.8 https://www.510kdatabase.net/og-image/k251159-power-wheelchair-fda-510k.jpg K251159 - Power wheelchair K251159 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zhenjiang Assure Medical Equipment Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k251605/ 2025-12-22 monthly 0.8 https://www.510kdatabase.net/og-image/k251605-dimplo-implant-system-fda-510k.jpg K251605 - DIMPLO Implant System K251605 is a FDA 510(k) cleared dental medical device. Manufacturer: DIMPLO, Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k251764/ 2025-12-22 monthly 0.8 https://www.510kdatabase.net/og-image/k251764-oxygen-concentrator-p2-o5e-fda-510k.jpg K251764 - Oxygen Concentrator-P2-O5E K251764 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Qingdao Kingon Medical Science and Technology Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k251783/ 2025-12-22 monthly 0.8 https://www.510kdatabase.net/og-image/k251783-inspire-hcr-and-hcr-dual-cardiotomy-fda-510k.jpg K251783 - Inspire HCR and HCR DUAL cardiotomy reservoirs K251783 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sorin Group Italia S.R.L.. Cleared Dec 2025. https://www.510kdatabase.net/k252068/ 2025-12-22 monthly 0.8 https://www.510kdatabase.net/og-image/k252068-mc2-portable-x-ray-system-fda-510k.jpg K252068 - MC2 Portable X-ray System K252068 is a FDA 510(k) cleared radiology medical device. Manufacturer: Oxos Medical. Cleared Dec 2025. https://www.510kdatabase.net/k252109/ 2025-12-22 monthly 0.8 https://www.510kdatabase.net/og-image/k252109-raystation-2024a-sp3-fda-510k.jpg K252109 - RayStation (2024A SP3) K252109 is a FDA 510(k) cleared radiology medical device. Manufacturer: RaySearch Laboratories AB (PUBL). Cleared Dec 2025. https://www.510kdatabase.net/k252361/ 2025-12-22 monthly 0.8 https://www.510kdatabase.net/og-image/k252361-accurecg-analysis-system-v20-fda-510k.jpg K252361 - AccurECG Analysis System (v2.0) K252361 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Accurkardia, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k252557/ 2025-12-22 monthly 0.8 https://www.510kdatabase.net/og-image/k252557-lumify-diagnostic-ultrasound-system-fda-510k.jpg K252557 - Lumify Diagnostic Ultrasound System K252557 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Ultrasound, LLC. Cleared Dec 2025. https://www.510kdatabase.net/k252611/ 2025-12-22 monthly 0.8 https://www.510kdatabase.net/og-image/k252611-aprevo-cervical-plating-system-fda-510k.jpg K252611 - aprevo® cervical plating system K252611 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Carlsmed, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k252616/ 2025-12-22 monthly 0.8 https://www.510kdatabase.net/og-image/k252616-portable-oxygen-concentrator-jlo-190p-fda-510k.jpg K252616 - Portable oxygen concentrator (JLO-190P) K252616 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Homed Medical Device Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k252673/ 2025-12-22 monthly 0.8 https://www.510kdatabase.net/og-image/k252673-lacertamatrix-fda-510k.jpg K252673 - LacertaMatrix K252673 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lacerta Life Science. Cleared Dec 2025. https://www.510kdatabase.net/k252743/ 2025-12-22 monthly 0.8 https://www.510kdatabase.net/og-image/k252743-stratafix-spiral-pds-plus-knotless-fda-510k.jpg K252743 - STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device K252743 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k252856/ 2025-12-22 monthly 0.8 https://www.510kdatabase.net/og-image/k252856-peekmed-web-fda-510k.jpg K252856 - PeekMed web K252856 is a FDA 510(k) cleared radiology medical device. Manufacturer: Peek Health, S.A.. Cleared Dec 2025. https://www.510kdatabase.net/k252981/ 2025-12-22 monthly 0.8 https://www.510kdatabase.net/og-image/k252981-embracemini-fda-510k.jpg K252981 - EmbraceMini K252981 is a FDA 510(k) cleared neurology medical device. Manufacturer: Empatica S.R.L.. Cleared Dec 2025. https://www.510kdatabase.net/k253222/ 2025-12-22 monthly 0.8 https://www.510kdatabase.net/og-image/k253222-gongdong-sharps-container-scr-01q-scr-fda-510k.jpg K253222 - Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G) K253222 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zhejiang Gongdong Medical Technology Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k253339/ 2025-12-22 monthly 0.8 https://www.510kdatabase.net/og-image/k253339-theracor-fda-510k.jpg K253339 - Theracor K253339 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stimlabs, LLC. Cleared Dec 2025. https://www.510kdatabase.net/k253661/ 2025-12-22 monthly 0.8 https://www.510kdatabase.net/og-image/k253661-tmini-miniature-robotic-system-fda-510k.jpg K253661 - TMINI Miniature Robotic System K253661 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: THINK Surgical, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k253664/ 2025-12-22 monthly 0.8 https://www.510kdatabase.net/og-image/k253664-skout-system-fda-510k.jpg K253664 - SKOUT system K253664 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Iterative Health. Cleared Dec 2025. https://www.510kdatabase.net/k253727/ 2025-12-22 monthly 0.8 https://www.510kdatabase.net/og-image/k253727-syndesmosis-tightrope-pro-fda-510k.jpg K253727 - Syndesmosis TightRope PRO K253727 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k253769/ 2025-12-22 monthly 0.8 https://www.510kdatabase.net/og-image/k253769-instylla-delivery-kit-fda-510k.jpg K253769 - Instylla Delivery Kit K253769 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Instylla, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k253781/ 2025-12-22 monthly 0.8 https://www.510kdatabase.net/og-image/k253781-innoclip-clip-applier-fda-510k.jpg K253781 - InnoClip Clip Applier K253781 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Taiwan Surgical Corporation. Cleared Dec 2025. https://www.510kdatabase.net/k253876/ 2025-12-22 monthly 0.8 https://www.510kdatabase.net/og-image/k253876-hedron-cervical-spacers-hedron-c-mis-fda-510k.jpg K253876 - HEDRON™ Cervical Spacers (HEDRON C-MIS™ Spacer) K253876 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k253903/ 2025-12-22 monthly 0.8 https://www.510kdatabase.net/og-image/k253903-innoclip-disposable-clip-applier-fda-510k.jpg K253903 - InnoClip Disposable Clip Applier K253903 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Taiwan Surgical Corporation. Cleared Dec 2025. https://www.510kdatabase.net/k232365/ 2025-12-19 monthly 0.8 https://www.510kdatabase.net/og-image/k232365-vivo-45-ls-fda-510k.jpg K232365 - Vivo 45 LS K232365 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Oconnell Regulatory Consultants, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k250314/ 2025-12-19 monthly 0.8 https://www.510kdatabase.net/og-image/k250314-medline-renewal-reprocessed-abbott-fda-510k.jpg K250314 - Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable Introducer K250314 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Surgical Instrument Service and Savings, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k250864/ 2025-12-19 monthly 0.8 https://www.510kdatabase.net/og-image/k250864-matriderm-plus-bi-layer-fda-510k.jpg K250864 - MatriDerm pluS+ Bi-Layer K250864 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medskin Solutions Dr. Suwelack AG. Cleared Dec 2025. https://www.510kdatabase.net/k250976/ 2025-12-19 monthly 0.8 https://www.510kdatabase.net/og-image/k250976-airbile-100-fda-510k.jpg K250976 - Airbile-100 K250976 is a FDA 510(k) cleared radiology medical device. Manufacturer: Poskom Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k250998/ 2025-12-19 monthly 0.8 https://www.510kdatabase.net/og-image/k250998-co2-laser-therapy-system-model-lfs-d9u-fda-510k.jpg K250998 - CO2 Laser Therapy System (Model: LFS-D9U) K250998 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sanhe?Lefis?Electronics?Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k251011/ 2025-12-19 monthly 0.8 https://www.510kdatabase.net/og-image/k251011-chiavaye-personal-moisturizer-fda-510k.jpg K251011 - Chiavaye Personal Moisturizer K251011 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Unipack, LLC. Cleared Dec 2025. https://www.510kdatabase.net/k251037/ 2025-12-19 monthly 0.8 https://www.510kdatabase.net/og-image/k251037-rectal-applicator-fda-510k.jpg K251037 - Rectal Applicator K251037 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nucletron B.V.. Cleared Dec 2025. https://www.510kdatabase.net/k251050/ 2025-12-19 monthly 0.8 https://www.510kdatabase.net/og-image/k251050-pectus-versa-system-fda-510k.jpg K251050 - Pectus Versa System K251050 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Gm Dos Reis Industria E Comercio. Cleared Dec 2025. https://www.510kdatabase.net/k251074/ 2025-12-19 monthly 0.8 https://www.510kdatabase.net/og-image/k251074-tru-liver-health-test-panel-fda-510k.jpg K251074 - Tru Liver Health Test Panel K251074 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Truvian Health. Cleared Dec 2025. https://www.510kdatabase.net/k251077/ 2025-12-19 monthly 0.8 https://www.510kdatabase.net/og-image/k251077-joule-1064nm-system-and-accessories-fda-510k.jpg K251077 - JOULE 1064nm System and Accessories K251077 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sciton, Inc. Cleared Dec 2025. https://www.510kdatabase.net/k251143/ 2025-12-19 monthly 0.8 https://www.510kdatabase.net/og-image/k251143-arm-blood-pressure-monitor-mj1l-mj2l-fda-510k.jpg K251143 - Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L) K251143 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ningbo Ranor Medical Science & Technology Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k251152/ 2025-12-19 monthly 0.8 https://www.510kdatabase.net/og-image/k251152-dblg2-fda-510k.jpg K251152 - DBLG2 K251152 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diabeloop. Cleared Dec 2025. https://www.510kdatabase.net/k251402/ 2025-12-19 monthly 0.8 https://www.510kdatabase.net/og-image/k251402-lia-1-catheter-542-1-fda-510k.jpg K251402 - LIA-1 Catheter (542-1) K251402 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Leadoptik, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k251469/ 2025-12-19 monthly 0.8 https://www.510kdatabase.net/og-image/k251469-endura-ureteral-stent-and-stent-set-fda-510k.jpg K251469 - Endura™ Ureteral Stent and Stent Set K251469 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cathegenix (Xiamen) Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k251572/ 2025-12-19 monthly 0.8 https://www.510kdatabase.net/og-image/k251572-erapid-with-etrack-system-fda-510k.jpg K251572 - eRapid with eTrack System K251572 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Pari Respiratory Equipment, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k251730/ 2025-12-19 monthly 0.8 https://www.510kdatabase.net/og-image/k251730-lia-console-542-7-fda-510k.jpg K251730 - LIA Console (542-7) K251730 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Leadoptik, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k251751/ 2025-12-19 monthly 0.8 https://www.510kdatabase.net/og-image/k251751-spo2-sensor-css032d-fda-510k.jpg K251751 - Spo2 Sensor CSS032D K251751 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Ykd Technology Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k252029/ 2025-12-19 monthly 0.8 https://www.510kdatabase.net/og-image/k252029-ai-cvd-fda-510k.jpg K252029 - AI-CVD K252029 is a FDA 510(k) cleared radiology medical device. Manufacturer: HeartLung Corporation. Cleared Dec 2025. https://www.510kdatabase.net/k252167/ 2025-12-19 monthly 0.8 https://www.510kdatabase.net/og-image/k252167-enhanced-silver-gelling-fiber-dressing-fda-510k.jpg K252167 - Enhanced Silver Gelling Fiber Dressing (OTC) Extra Enhanced Silver Gelling Fiber Dressing (Prescription) K252167 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Qingdao Bright Moon Biomedical Materials Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k252284/ 2025-12-19 monthly 0.8 https://www.510kdatabase.net/og-image/k252284-emurmur-heart-ai-fda-510k.jpg K252284 - eMurmur Heart AI K252284 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Csd Labs. Cleared Dec 2025. https://www.510kdatabase.net/k252342/ 2025-12-19 monthly 0.8 https://www.510kdatabase.net/og-image/k252342-electric-breast-pump-ym-8807-ym-8805-fda-510k.jpg K252342 - Electric Breast Pump (YM-8807, YM-8805, YM-8806, YM-8810) K252342 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Guangdong Youmeng Electrical Technology Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k252480/ 2025-12-19 monthly 0.8 https://www.510kdatabase.net/og-image/k252480-ce-deliver-dlv-fda-510k.jpg K252480 - CE Deliver (DLV) K252480 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: CapsoVision, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k252670/ 2025-12-19 monthly 0.8 https://www.510kdatabase.net/og-image/k252670-alzevita-fda-510k.jpg K252670 - Alzevita K252670 is a FDA 510(k) cleared radiology medical device. Manufacturer: TOPIA MEDTECH LIMITED. Cleared Dec 2025. https://www.510kdatabase.net/k252754/ 2025-12-19 monthly 0.8 https://www.510kdatabase.net/og-image/k252754-wearable-electric-breast-pump-ym-8803-fda-510k.jpg K252754 - Wearable Electric Breast Pump (YM-8803) K252754 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Guangdong Youmeng Electrical Technology Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k252780/ 2025-12-19 monthly 0.8 https://www.510kdatabase.net/og-image/k252780-lcd-monitor-cl1902a-cl2103f-fda-510k.jpg K252780 - LCD Monitor (CL1902A, CL2103F) K252780 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Beacon Display Technology Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k252781/ 2025-12-19 monthly 0.8 https://www.510kdatabase.net/og-image/k252781-msfx-mikron-peek-cages-fda-510k.jpg K252781 - MSFX MIKRON PEEK CAGES K252781 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Mikron Makina Sanayi VE Tic. Ltd. Sti.. Cleared Dec 2025. https://www.510kdatabase.net/k252838/ 2025-12-19 monthly 0.8 https://www.510kdatabase.net/og-image/k252838-magnetom-sola-fda-510k.jpg K252838 - MAGNETOM Sola K252838 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Healthcare GmbH. Cleared Dec 2025. https://www.510kdatabase.net/k252863/ 2025-12-19 monthly 0.8 https://www.510kdatabase.net/og-image/k252863-clearcalc-model-radca-v26-fda-510k.jpg K252863 - ClearCalc Model RADCA V2.6 K252863 is a FDA 510(k) cleared radiology medical device. Manufacturer: Radformation, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k252877/ 2025-12-19 monthly 0.8 https://www.510kdatabase.net/og-image/k252877-sandro-dual-fda-510k.jpg K252877 - SANDRO Dual K252877 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wontech Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k252892/ 2025-12-19 monthly 0.8 https://www.510kdatabase.net/og-image/k252892-scout-md-surgical-guidance-system-fda-510k.jpg K252892 - SCOUT MD Surgical Guidance System K252892 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k252974/ 2025-12-19 monthly 0.8 https://www.510kdatabase.net/og-image/k252974-empowr-knee-fda-510k.jpg K252974 - EMPOWR Knee K252974 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Encore Medical, L.P.. Cleared Dec 2025. https://www.510kdatabase.net/k253054/ 2025-12-19 monthly 0.8 https://www.510kdatabase.net/og-image/k253054-led-light-therapy-mask-m19-m19-1-m19-2-fda-510k.jpg K253054 - LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6) K253054 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k253086/ 2025-12-19 monthly 0.8 https://www.510kdatabase.net/og-image/k253086-led-light-therapy-device-models-sg-fm-fda-510k.jpg K253086 - LED Light Therapy Device (Models: SG-FM, SG-FE) K253086 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sunglor Technology Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k253161/ 2025-12-19 monthly 0.8 https://www.510kdatabase.net/og-image/k253161-balanced-knee-system-trimax-porous-fda-510k.jpg K253161 - Balanced Knee System TriMax Porous Femoral Components K253161 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ortho Development Corp.. Cleared Dec 2025. https://www.510kdatabase.net/k253202/ 2025-12-19 monthly 0.8 https://www.510kdatabase.net/og-image/k253202-hoffmann-lrf-system-fda-510k.jpg K253202 - Hoffmann LRF System K253202 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker GmbH. Cleared Dec 2025. https://www.510kdatabase.net/k253358/ 2025-12-19 monthly 0.8 https://www.510kdatabase.net/og-image/k253358-diazyme-human-kappa-k-free-light-chain-fda-510k.jpg K253358 - Diazyme Human Kappa (k) Free Light Chain Assay K253358 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diazyme Laboratories, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k253373/ 2025-12-19 monthly 0.8 https://www.510kdatabase.net/og-image/k253373-southern-craniomaxillofacial-cmf-system-fda-510k.jpg K253373 - Southern Craniomaxillofacial (CMF) System K253373 is a FDA 510(k) cleared dental medical device. Manufacturer: Southern Medical (Pty) , Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k253409/ 2025-12-19 monthly 0.8 https://www.510kdatabase.net/og-image/k253409-c320lbb-delivery-system-c320lbbs45-fda-510k.jpg K253409 - C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) K253409 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k253479/ 2025-12-19 monthly 0.8 https://www.510kdatabase.net/og-image/k253479-optiflow-switch-filtered-nasal-fda-510k.jpg K253479 - Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J) K253479 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Fisher &Paykel Healthcare , Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k253577/ 2025-12-19 monthly 0.8 https://www.510kdatabase.net/og-image/k253577-ib3d-pl-spinal-system-a24000000-ib3d-fda-510k.jpg K253577 - IB3D™ PL Spinal System (A24000000 / IB3D Universal Implant Inserter) K253577 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medicrea International S.A.S. (Medtronic). Cleared Dec 2025. https://www.510kdatabase.net/k253613/ 2025-12-19 monthly 0.8 https://www.510kdatabase.net/og-image/k253613-monkey-rings-external-ring-fixation-fda-510k.jpg K253613 - Monkey Rings External Ring Fixation System K253613 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paragon 28, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k253616/ 2025-12-19 monthly 0.8 https://www.510kdatabase.net/og-image/k253616-protekdilate-vascular-access-kit-fda-510k.jpg K253616 - ProtekDilate Vascular Access Kit K253616 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sorin Group Italia S.R.L.. Cleared Dec 2025. https://www.510kdatabase.net/k253733/ 2025-12-19 monthly 0.8 https://www.510kdatabase.net/og-image/k253733-star-apollo-mapping-system-fda-510k.jpg K253733 - STAR Apollo™ Mapping System K253733 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Rhythm AI, Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k254063/ 2025-12-19 monthly 0.8 https://www.510kdatabase.net/og-image/k254063-icem-universal-plus-fda-510k.jpg K254063 - iCEM Universal Plus K254063 is a FDA 510(k) cleared dental medical device. Manufacturer: Kulzer, LLC. Cleared Dec 2025. https://www.510kdatabase.net/k250914/ 2025-12-18 monthly 0.8 https://www.510kdatabase.net/og-image/k250914-mediai-ba-fda-510k.jpg K250914 - MediAI-BA K250914 is a FDA 510(k) cleared radiology medical device. Manufacturer: Crescom Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k250993/ 2025-12-18 monthly 0.8 https://www.510kdatabase.net/og-image/k250993-single-use-cytology-brush-v-bc-v600p-fda-510k.jpg K250993 - Single Use Cytology Brush V (BC-V600P-3010) K250993 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Medical Systems Corporation. Cleared Dec 2025. https://www.510kdatabase.net/k251562/ 2025-12-18 monthly 0.8 https://www.510kdatabase.net/og-image/k251562-otscneo-system-set-10003n-14n-10027n-31n-fda-510k.jpg K251562 - OTSCneo System Set (100.03n-14n, 100.27n-31n) K251562 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ovesco Endoscopy AG. Cleared Dec 2025. https://www.510kdatabase.net/k251915/ 2025-12-18 monthly 0.8 https://www.510kdatabase.net/og-image/k251915-amethyst-hp-pta-otw-0035-catheter-fda-510k.jpg K251915 - Amethyst HP PTA OTW 0.035 Catheter K251915 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Natec Medical , Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k252071/ 2025-12-18 monthly 0.8 https://www.510kdatabase.net/og-image/k252071-reflexion-medical-radiotherapy-system-fda-510k.jpg K252071 - RefleXion Medical Radiotherapy System, Reflexion X2 K252071 is a FDA 510(k) cleared radiology medical device. Manufacturer: Reflexion Medical, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k252235/ 2025-12-18 monthly 0.8 https://www.510kdatabase.net/og-image/k252235-pvad-iq-software-fda-510k.jpg K252235 - PVAD IQ Software K252235 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ultrasight , Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k252320/ 2025-12-18 monthly 0.8 https://www.510kdatabase.net/og-image/k252320-simda-abutments-fda-510k.jpg K252320 - SIMDA Abutments K252320 is a FDA 510(k) cleared dental medical device. Manufacturer: Simda Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k252348/ 2025-12-18 monthly 0.8 https://www.510kdatabase.net/og-image/k252348-tomey-optical-biometer-oa-2000-oa-2000-fda-510k.jpg K252348 - Tomey Optical Biometer OA-2000 (OA-2000) K252348 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Tomey Corporation. Cleared Dec 2025. https://www.510kdatabase.net/k252402/ 2025-12-18 monthly 0.8 https://www.510kdatabase.net/og-image/k252402-midline-catheter-fda-510k.jpg K252402 - Midline Catheter K252402 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terumo Medical Products Hangzhou Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k252533/ 2025-12-18 monthly 0.8 https://www.510kdatabase.net/og-image/k252533-hemosphere-alta-advanced-monitoring-fda-510k.jpg K252533 - HemoSphere Alta Advanced Monitoring Platform (ALTAALL1 K252533 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences. Cleared Dec 2025. https://www.510kdatabase.net/k252793/ 2025-12-18 monthly 0.8 https://www.510kdatabase.net/og-image/k252793-armi-endoscopic-video-image-processor-fda-510k.jpg K252793 - ARMI® Endoscopic Video Image Processor (JY-MIP-3000) K252793 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Jiangsu Jiyuan Medical Technology Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k252956/ 2025-12-18 monthly 0.8 https://www.510kdatabase.net/og-image/k252956-helo-thrombectomy-system-fda-510k.jpg K252956 - Helo Thrombectomy System K252956 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Endovascular Engineering, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k252976/ 2025-12-18 monthly 0.8 https://www.510kdatabase.net/og-image/k252976-park-dental-nylon-mad-fda-510k.jpg K252976 - Park Dental Nylon MAD K252976 is a FDA 510(k) cleared dental medical device. Manufacturer: Park Dental Research Corp.. Cleared Dec 2025. https://www.510kdatabase.net/k253516/ 2025-12-18 monthly 0.8 https://www.510kdatabase.net/og-image/k253516-assert-iq-dm5100-fda-510k.jpg K253516 - Assert-IQ (DM5100) K253516 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared Dec 2025. https://www.510kdatabase.net/k253518/ 2025-12-18 monthly 0.8 https://www.510kdatabase.net/og-image/k253518-fx-coral-40-fda-510k.jpg K253518 - FX CorAL 40 K253518 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC. Cleared Dec 2025. https://www.510kdatabase.net/k253758/ 2025-12-18 monthly 0.8 https://www.510kdatabase.net/og-image/k253758-dental-cone-fda-510k.jpg K253758 - Dental Cone K253758 is a FDA 510(k) cleared dental medical device. Manufacturer: Medizin Produkte Neustadt GmbH (Mpn). Cleared Dec 2025. https://www.510kdatabase.net/k253915/ 2025-12-18 monthly 0.8 https://www.510kdatabase.net/og-image/k253915-moviva-hybrid-ablation-probe-fda-510k.jpg K253915 - MOVIVA® Hybrid Ablation Probe K253915 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Erbe Elektromedizin GmbH. Cleared Dec 2025. https://www.510kdatabase.net/k250854/ 2025-12-17 monthly 0.8 https://www.510kdatabase.net/og-image/k250854-multi-parameter-patient-monitor-n10-fda-510k.jpg K250854 - Multi-parameter Patient Monitor (N10) K250854 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Comen Medical Instruments Co.,Ltd. Cleared Dec 2025. https://www.510kdatabase.net/k251416/ 2025-12-17 monthly 0.8 https://www.510kdatabase.net/og-image/k251416-ultrasight-guidance-fda-510k.jpg K251416 - UltraSight Guidance K251416 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ultrasight , Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k252191/ 2025-12-17 monthly 0.8 https://www.510kdatabase.net/og-image/k252191-brusio-trauma-toolbox-system-fda-510k.jpg K252191 - BRUSIO Trauma Toolbox System K252191 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Bonebridge AG. Cleared Dec 2025. https://www.510kdatabase.net/k252398/ 2025-12-17 monthly 0.8 https://www.510kdatabase.net/og-image/k252398-surflo-hybria-closed-system-safety-iv-fda-510k.jpg K252398 - SURFLO Hybria Closed System Safety IV Catheter K252398 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terumo Medical Products Hangzhou Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k252417/ 2025-12-17 monthly 0.8 https://www.510kdatabase.net/og-image/k252417-amplatzer-piccolo-delivery-system-9-fda-510k.jpg K252417 - Amplatzer Piccolo™ Delivery System (9-PDS-04F-045) K252417 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared Dec 2025. https://www.510kdatabase.net/k252508/ 2025-12-17 monthly 0.8 https://www.510kdatabase.net/og-image/k252508-intri26-introducer-sheath-fda-510k.jpg K252508 - Intri26 Introducer Sheath K252508 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inari Medical, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k252518/ 2025-12-17 monthly 0.8 https://www.510kdatabase.net/og-image/k252518-duoprosstm-smart-cap-type-i-fda-510k.jpg K252518 - DuoprossTM Smart Cap (Type I) K252518 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Duopross Meditech Corporate. Cleared Dec 2025. https://www.510kdatabase.net/k252739/ 2025-12-17 monthly 0.8 https://www.510kdatabase.net/og-image/k252739-ethicon-4000-45mm-compact-stapler-fda-510k.jpg K252739 - ETHICON™ 4000 45mm Compact Stapler (EC3DT45C) K252739 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon Endo-Surgery, LLC. Cleared Dec 2025. https://www.510kdatabase.net/k252922/ 2025-12-17 monthly 0.8 https://www.510kdatabase.net/og-image/k252922-neosoma-brain-mets-fda-510k.jpg K252922 - Neosoma Brain Mets K252922 is a FDA 510(k) cleared radiology medical device. Manufacturer: Neosoma, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k252983/ 2025-12-17 monthly 0.8 https://www.510kdatabase.net/og-image/k252983-wrinkle-retreat-pro-light-therapy-face-fda-510k.jpg K252983 - Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03) K252983 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Goodwind Technology Development Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k253093/ 2025-12-17 monthly 0.8 https://www.510kdatabase.net/og-image/k253093-vital-spinal-fixation-system-fda-510k.jpg K253093 - Vital™ Spinal Fixation System K253093 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Highridge Medical, LLC. Cleared Dec 2025. https://www.510kdatabase.net/k253710/ 2025-12-17 monthly 0.8 https://www.510kdatabase.net/og-image/k253710-dexcom-g7-continuous-glucose-fda-510k.jpg K253710 - Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System K253710 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dexcom, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k253719/ 2025-12-17 monthly 0.8 https://www.510kdatabase.net/og-image/k253719-unscented-menstrual-long-applicator-fda-510k.jpg K253719 - Unscented Menstrual Long Applicator Tampon K253719 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Unibeauty (Hubei) Technology Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k253721/ 2025-12-17 monthly 0.8 https://www.510kdatabase.net/og-image/k253721-kheiron-spinal-fixation-system-fda-510k.jpg K253721 - KHEIRON® Spinal Fixation System, including patient specific K-ROD K253721 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: S.M.A.I.O. Cleared Dec 2025. https://www.510kdatabase.net/k253839/ 2025-12-17 monthly 0.8 https://www.510kdatabase.net/og-image/k253839-elecsys-anti-sars-cov-2-fda-510k.jpg K253839 - Elecsys Anti-SARS-CoV-2 K253839 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Diagnostics. Cleared Dec 2025. https://www.510kdatabase.net/k250925/ 2025-12-16 monthly 0.8 https://www.510kdatabase.net/og-image/k250925-advia-centaur-cytokeratin-fragment-21-1-fda-510k.jpg K250925 - ADVIA Centaur Cytokeratin Fragment 21-1 K250925 is a FDA 510(k) cleared immunology medical device. Manufacturer: Fujirebio Diagnostics,Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k251256/ 2025-12-16 monthly 0.8 https://www.510kdatabase.net/og-image/k251256-pentax-medical-video-upper-gi-scopes-fda-510k.jpg K251256 - PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family) K251256 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Pentax of America, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k251745/ 2025-12-16 monthly 0.8 https://www.510kdatabase.net/og-image/k251745-welch-allyn-flexiport-blood-pressure-fda-510k.jpg K251745 - Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) K251745 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corporation. Cleared Dec 2025. https://www.510kdatabase.net/k251763/ 2025-12-16 monthly 0.8 https://www.510kdatabase.net/og-image/k251763-iriseg-fda-510k.jpg K251763 - IRISeg K251763 is a FDA 510(k) cleared radiology medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k251771/ 2025-12-16 monthly 0.8 https://www.510kdatabase.net/og-image/k251771-cambridge-partial-knee-fda-510k.jpg K251771 - Cambridge Partial Knee K251771 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Signature Orthopaedics Pty, Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k251893/ 2025-12-16 monthly 0.8 https://www.510kdatabase.net/og-image/k251893-skan-c-pulsar-fda-510k.jpg K251893 - SKAN C PULSAR K251893 is a FDA 510(k) cleared radiology medical device. Manufacturer: Skanray Technologies Limited. Cleared Dec 2025. https://www.510kdatabase.net/k251951/ 2025-12-16 monthly 0.8 https://www.510kdatabase.net/og-image/k251951-single-use-video-flexible-fda-510k.jpg K251951 - Single-Use Video Flexible Ureterorenoscope (RP-U-C03R9, RP-U-C03R3, RP-U-C03S9, RP-U-C03S3) K251951 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Guangzhou Red Pine Medical Instrument Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k252111/ 2025-12-16 monthly 0.8 https://www.510kdatabase.net/og-image/k252111-versius-surgical-system-versius-plus-fda-510k.jpg K252111 - Versius Surgical System (Versius Plus) K252111 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cmr Surgical Limited. Cleared Dec 2025. https://www.510kdatabase.net/k252204/ 2025-12-16 monthly 0.8 https://www.510kdatabase.net/og-image/k252204-prolaio-evo2peak-module-version-10-fda-510k.jpg K252204 - prolaio eVO2peak Module (Version 1.0) K252204 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Prolaio, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k252268/ 2025-12-16 monthly 0.8 https://www.510kdatabase.net/og-image/k252268-v-series-portable-oxygen-concentrator-fda-510k.jpg K252268 - V series portable oxygen concentrator (V5, V5C, V6, V6C) K252268 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Harveymed Technology Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k252373/ 2025-12-16 monthly 0.8 https://www.510kdatabase.net/og-image/k252373-bioflo-hybrid-picc-with-endexo-fda-510k.jpg K252373 - BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology K252373 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Spectrum Vascular. Cleared Dec 2025. https://www.510kdatabase.net/k252468/ 2025-12-16 monthly 0.8 https://www.510kdatabase.net/og-image/k252468-single-use-digital-flexible-fda-510k.jpg K252468 - Single-use Digital Flexible Ureteroscope (GY-UR9.3) K252468 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Zhejiang Geyi Medical Instrument Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k252919/ 2025-12-16 monthly 0.8 https://www.510kdatabase.net/og-image/k252919-identify-50-fda-510k.jpg K252919 - IDENTIFY (5.0) K252919 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k252940/ 2025-12-16 monthly 0.8 https://www.510kdatabase.net/og-image/k252940-vr-personal-protective-level-3-gown-vr-fda-510k.jpg K252940 - VR® Personal Protective Level 3 Gown (VR Gowns) K252940 is a FDA 510(k) cleared general hospital medical device. Manufacturer: PolyConversions, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k253118/ 2025-12-16 monthly 0.8 https://www.510kdatabase.net/og-image/k253118-companion-spine-diam-instrumentation-fda-510k.jpg K253118 - Companion Spine DIAM™ Instrumentation K253118 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Companion Spine France. Cleared Dec 2025. https://www.510kdatabase.net/k253620/ 2025-12-16 monthly 0.8 https://www.510kdatabase.net/og-image/k253620-troclose-1200-fda-510k.jpg K253620 - TroClose 1200 K253620 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Gordian Surgical, Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k250319/ 2025-12-15 monthly 0.8 https://www.510kdatabase.net/og-image/k250319-mfuse-ms001-fda-510k.jpg K250319 - MFUSE (MS001) K250319 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Machina Medical, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k251302/ 2025-12-15 monthly 0.8 https://www.510kdatabase.net/og-image/k251302-optimesh-multiplanar-expandable-fda-510k.jpg K251302 - OptiMesh Multiplanar Expandable Interbody Fusion System K251302 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spineology, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k251770/ 2025-12-15 monthly 0.8 https://www.510kdatabase.net/og-image/k251770-sleepres-pap-system-fda-510k.jpg K251770 - SleepRes PAP System K251770 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sleepres, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k252574/ 2025-12-15 monthly 0.8 https://www.510kdatabase.net/og-image/k252574-erchonia-clx-model-cfl-fda-510k.jpg K252574 - Erchonia CLX (Model # CFL) K252574 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Erchonia Corporation. Cleared Dec 2025. https://www.510kdatabase.net/k252675/ 2025-12-15 monthly 0.8 https://www.510kdatabase.net/og-image/k252675-da-vinci-sp-surgical-system-sp1098-fda-510k.jpg K252675 - da Vinci SP Surgical System (SP1098) K252675 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k252898/ 2025-12-15 monthly 0.8 https://www.510kdatabase.net/og-image/k252898-triathlon-tritanium-asymmetric-patella-fda-510k.jpg K252898 - Triathlon® Tritanium® Asymmetric Patella K252898 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp., Dba Stryker Orthopaedics. Cleared Dec 2025. https://www.510kdatabase.net/k252935/ 2025-12-15 monthly 0.8 https://www.510kdatabase.net/og-image/k252935-hybrid-personal-lubricant-fda-510k.jpg K252935 - Hybrid personal lubricant (water&silicone) (5ml, 8ml, 10ml, 12ml, 15ml, 20ml, 30ml, 50ml, 60ml, 75ml, 90ml, 100ml, 120ml, 150ml, 180ml, 200ml, 250ml, 300ml, 500ml) K252935 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Foshan Pingchuang Medical Technology Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k252950/ 2025-12-15 monthly 0.8 https://www.510kdatabase.net/og-image/k252950-paradigm-system-fda-510k.jpg K252950 - Paradigm System K252950 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Proprio, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k253101/ 2025-12-15 monthly 0.8 https://www.510kdatabase.net/og-image/k253101-hypervue-imaging-system-integrated-fda-510k.jpg K253101 - HyperVue™ Imaging System - Integrated K253101 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Spectrawave, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k253403/ 2025-12-15 monthly 0.8 https://www.510kdatabase.net/og-image/k253403-femvue-controlled-saline-air-device-fda-510k.jpg K253403 - FemVue® Controlled Saline-Air Device (FSA-300) K253403 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Femasys, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k253677/ 2025-12-15 monthly 0.8 https://www.510kdatabase.net/og-image/k253677-tembo-embolic-system-fda-510k.jpg K253677 - Tembo Embolic System K253677 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Instylla, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k253741/ 2025-12-15 monthly 0.8 https://www.510kdatabase.net/og-image/k253741-vstick-vascular-access-set-fda-510k.jpg K253741 - V•Stick™ Vascular Access Set K253741 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Argon Medical Devices, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k250851/ 2025-12-14 monthly 0.8 https://www.510kdatabase.net/og-image/k250851-hypnos-369054-200-fda-510k.jpg K250851 - Hypnos (369054-200) K250851 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cadwell Industries, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k242817/ 2025-12-12 monthly 0.8 https://www.510kdatabase.net/og-image/k242817-jason-membrane-fda-510k.jpg K242817 - Jason membrane K242817 is a FDA 510(k) cleared dental medical device. Manufacturer: Botiss Biomaterials GmbH. Cleared Dec 2025. https://www.510kdatabase.net/k250488/ 2025-12-12 monthly 0.8 https://www.510kdatabase.net/og-image/k250488-ceryn-intimate-care-fda-510k.jpg K250488 - Cerynë Intimate Care K250488 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ansella Therapeutics. Cleared Dec 2025. https://www.510kdatabase.net/k250821/ 2025-12-12 monthly 0.8 https://www.510kdatabase.net/og-image/k250821-horizon-af-plus-system-integrated-al-fda-510k.jpg K250821 - Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300) K250821 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Eurosets S.R.L. Cleared Dec 2025. https://www.510kdatabase.net/k250847/ 2025-12-12 monthly 0.8 https://www.510kdatabase.net/og-image/k250847-vaporshield-fda-510k.jpg K250847 - VaporShield K250847 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Vault Paragon Group, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k250863/ 2025-12-12 monthly 0.8 https://www.510kdatabase.net/og-image/k250863-fujifilm-ultrasonic-endoscope-eb-710us-fda-510k.jpg K250863 - FUJIFILM Ultrasonic Endoscope EB-710US K250863 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Fujifilm Corporation. Cleared Dec 2025. https://www.510kdatabase.net/k250974/ 2025-12-12 monthly 0.8 https://www.510kdatabase.net/og-image/k250974-bio-arterial-deluxe-ic-bap-dx-fda-510k.jpg K250974 - Bio Arterial Deluxe (IC-BAP-DX) K250974 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bio Compression Systems, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k251085/ 2025-12-12 monthly 0.8 https://www.510kdatabase.net/og-image/k251085-ihealth-flu-abcovid-19rsv-rapid-test-fda-510k.jpg K251085 - iHealth Flu A&B/COVID-19/RSV Rapid Test K251085 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Ihealth Labs, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k251089/ 2025-12-12 monthly 0.8 https://www.510kdatabase.net/og-image/k251089-exel-disposable-syringe-fda-510k.jpg K251089 - EXEL Disposable Syringe K251089 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Exelint International, Co.. Cleared Dec 2025. https://www.510kdatabase.net/k251092/ 2025-12-12 monthly 0.8 https://www.510kdatabase.net/og-image/k251092-ihealth-flu-abcovid-19-rapid-test-fda-510k.jpg K251092 - iHealth Flu A&B/COVID-19 Rapid Test K251092 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Ihealth Labs, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k251177/ 2025-12-12 monthly 0.8 https://www.510kdatabase.net/og-image/k251177-self-seal-sterilization-pouch-and-roll-fda-510k.jpg K251177 - Self-Seal Sterilization Pouch and Roll K251177 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guangdong Maidi Medical Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k251989/ 2025-12-12 monthly 0.8 https://www.510kdatabase.net/og-image/k251989-vizmark-preloaded-tissue-marker-device-fda-510k.jpg K251989 - VizMark Preloaded Tissue Marker Device (VM-0001) K251989 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Breast-Med, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k252090/ 2025-12-12 monthly 0.8 https://www.510kdatabase.net/og-image/k252090-pterygoid-indication-for-gm-helix-fda-510k.jpg K252090 - Pterygoid Indication for GM Helix Implants K252090 is a FDA 510(k) cleared dental medical device. Manufacturer: JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A.. Cleared Dec 2025. https://www.510kdatabase.net/k252120/ 2025-12-12 monthly 0.8 https://www.510kdatabase.net/og-image/k252120-fundus-on-phone-non-mydriatic-fop-nm-10-fda-510k.jpg K252120 - Fundus On Phone Non Mydriatic (FOP NM-10) K252120 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Remidio Innovative Solutions Private Limited. Cleared Dec 2025. https://www.510kdatabase.net/k252273/ 2025-12-12 monthly 0.8 https://www.510kdatabase.net/og-image/k252273-therapy-us-fda-510k.jpg K252273 - Therapy US K252273 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Dmc Importa??o E Exporta??o DE Equipamentos Ltda. Cleared Dec 2025. https://www.510kdatabase.net/k252391/ 2025-12-12 monthly 0.8 https://www.510kdatabase.net/og-image/k252391-revi-system-fda-510k.jpg K252391 - Revi System K252391 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Bluewind Medical , Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k252681/ 2025-12-12 monthly 0.8 https://www.510kdatabase.net/og-image/k252681-encor-encompass-breast-biopsy-and-fda-510k.jpg K252681 - EnCor EnCompass™ Breast Biopsy and Tissue Removal System K252681 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bard Peripheral Vascular, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k252745/ 2025-12-12 monthly 0.8 https://www.510kdatabase.net/og-image/k252745-halo-sterile-single-use-radial-fiber-fda-510k.jpg K252745 - Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8) K252745 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Micro-Energy Medical Technology Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k252785/ 2025-12-12 monthly 0.8 https://www.510kdatabase.net/og-image/k252785-topcem-vigor-sa-self-adhesive-resin-fda-510k.jpg K252785 - TopCEM Vigor SA Self-Adhesive Resin Cement K252785 is a FDA 510(k) cleared dental medical device. Manufacturer: Rizhao Huge Biomaterials Company, Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k253489/ 2025-12-12 monthly 0.8 https://www.510kdatabase.net/og-image/k253489-swoop-portable-mr-imaging-system-fda-510k.jpg K253489 - Swoop® Portable MR Imaging® System K253489 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hyperfine, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k253609/ 2025-12-12 monthly 0.8 https://www.510kdatabase.net/og-image/k253609-traumagel-20-hemostatic-gel-fda-510k.jpg K253609 - TRAUMAGEL® 2.0 Hemostatic Gel K253609 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cresilon, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k253749/ 2025-12-12 monthly 0.8 https://www.510kdatabase.net/og-image/k253749-affixus-natural-nail-proximal-humeral-fda-510k.jpg K253749 - Affixus® Natural Nail® Proximal Humeral System K253749 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer Switzerland Manufacturing GmbH. Cleared Dec 2025. https://www.510kdatabase.net/k250988/ 2025-12-11 monthly 0.8 https://www.510kdatabase.net/og-image/k250988-kls-martin-pure-pectus-system-fda-510k.jpg K250988 - KLS Martin Pure Pectus System K250988 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: KLS-Martin L.P.. Cleared Dec 2025. https://www.510kdatabase.net/k251883/ 2025-12-11 monthly 0.8 https://www.510kdatabase.net/og-image/k251883-mim-lesionid-pro-fda-510k.jpg K251883 - MIM – LesionID Pro K251883 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mim Software, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k252482/ 2025-12-11 monthly 0.8 https://www.510kdatabase.net/og-image/k252482-cognet-ai-mt-fda-510k.jpg K252482 - CogNet AI-MT+ K252482 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medcognetics, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k252694/ 2025-12-11 monthly 0.8 https://www.510kdatabase.net/og-image/k252694-target-detachable-coil-fda-510k.jpg K252694 - Target Detachable Coil K252694 is a FDA 510(k) cleared neurology medical device. Manufacturer: Stryker Neurovascular. Cleared Dec 2025. https://www.510kdatabase.net/k252897/ 2025-12-11 monthly 0.8 https://www.510kdatabase.net/og-image/k252897-aps-osteotomy-fixation-system-0945-fda-510k.jpg K252897 - APS Osteotomy Fixation System (0945-1302-xx /4.5mm Cortex Screw) K252897 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: A Plus Biotechnology Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k252941/ 2025-12-11 monthly 0.8 https://www.510kdatabase.net/og-image/k252941-halyard-adult-face-mask-with-so-soft-fda-510k.jpg K252941 - HALYARD* Adult Face Mask with SO SOFT* Lining and SO SOFT* Earloops K252941 is a FDA 510(k) cleared general hospital medical device. Manufacturer: O&M Halyard, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k252997/ 2025-12-11 monthly 0.8 https://www.510kdatabase.net/og-image/k252997-hyperflex-bunion-correction-system-fda-510k.jpg K252997 - HyperFlex® Bunion Correction System K252997 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Hyperflex Medical. Cleared Dec 2025. https://www.510kdatabase.net/k253141/ 2025-12-11 monthly 0.8 https://www.510kdatabase.net/og-image/k253141-deeprhythmai-fda-510k.jpg K253141 - DeepRhythmAI K253141 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medicalgorithmics S.A.. Cleared Dec 2025. https://www.510kdatabase.net/k253200/ 2025-12-11 monthly 0.8 https://www.510kdatabase.net/og-image/k253200-cervical-spine-truss-system-stand-fda-510k.jpg K253200 - Cervical Spine Truss System - Stand Alone (CSTS-SA) K253200 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 4Web Medical, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k250192/ 2025-12-10 monthly 0.8 https://www.510kdatabase.net/og-image/k250192-verisafe-safety-retractable-insulin-fda-510k.jpg K250192 - Verisafe Safety Retractable Insulin Syringes K250192 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Promisemed Hangzhou Meditech Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k251598/ 2025-12-10 monthly 0.8 https://www.510kdatabase.net/og-image/k251598-intellidrop-fda-510k.jpg K251598 - Intellidrop K251598 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainspace, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k252497/ 2025-12-10 monthly 0.8 https://www.510kdatabase.net/og-image/k252497-sansa-hsat-fda-510k.jpg K252497 - SANSA HSAT K252497 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Huxley Medical. Cleared Dec 2025. https://www.510kdatabase.net/k252826/ 2025-12-10 monthly 0.8 https://www.510kdatabase.net/og-image/k252826-arix-femur-nail-system-fda-510k.jpg K252826 - ARIX Femur Nail System K252826 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Jeil Medical Corporation. Cleared Dec 2025. https://www.510kdatabase.net/k243449/ 2025-12-09 monthly 0.8 https://www.510kdatabase.net/og-image/k243449-infinitt-dps-fda-510k.jpg K243449 - INFINITT DPS K243449 is a FDA 510(k) cleared pathology medical device. Manufacturer: Infinitt Healthcare Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k250742/ 2025-12-09 monthly 0.8 https://www.510kdatabase.net/og-image/k250742-focused-cryotherapy-system-fda-510k.jpg K250742 - Focused Cryotherapy System K250742 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Focused Cryo, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k250805/ 2025-12-09 monthly 0.8 https://www.510kdatabase.net/og-image/k250805-devilbiss-pulmo2-10-liter-oxygen-fda-510k.jpg K250805 - DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW) K250805 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Devilbiss Healthcare, LLC. Cleared Dec 2025. https://www.510kdatabase.net/k251199/ 2025-12-09 monthly 0.8 https://www.510kdatabase.net/og-image/k251199-allia-moveo-fda-510k.jpg K251199 - Allia Moveo K251199 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems SCS. Cleared Dec 2025. https://www.510kdatabase.net/k252154/ 2025-12-09 monthly 0.8 https://www.510kdatabase.net/og-image/k252154-portable-electro-stimulation-therapy-fda-510k.jpg K252154 - Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-2320SP) K252154 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Guangzhou Longest Medical Technology Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k252343/ 2025-12-09 monthly 0.8 https://www.510kdatabase.net/og-image/k252343-atlantis-abutments-in-titanium-fda-510k.jpg K252343 - Atlantis® Abutments in Titanium K252343 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona. Cleared Dec 2025. https://www.510kdatabase.net/k252808/ 2025-12-09 monthly 0.8 https://www.510kdatabase.net/og-image/k252808-glasionomer-fx-lc-fda-510k.jpg K252808 - GlasIonomer FX-LC K252808 is a FDA 510(k) cleared dental medical device. Manufacturer: Shofu Dental Corporation. Cleared Dec 2025. https://www.510kdatabase.net/k253706/ 2025-12-09 monthly 0.8 https://www.510kdatabase.net/og-image/k253706-lancing-device-hh-xv-t-fda-510k.jpg K253706 - Lancing device (HH-XV-T) K253706 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Tianjin Huahong Technology Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k250190/ 2025-12-08 monthly 0.8 https://www.510kdatabase.net/og-image/k250190-sequential-compression-system-scd600-fda-510k.jpg K250190 - Sequential Compression System (SCD600) K250190 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Comen Medical Instruments Co.,Ltd. Cleared Dec 2025. https://www.510kdatabase.net/k250258/ 2025-12-08 monthly 0.8 https://www.510kdatabase.net/og-image/k250258-heartbeam-aimigo-with-12-l-ecg-fda-510k.jpg K250258 - HeartBeam AIMIGo with 12-L ECG Synthesis Software System K250258 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Heartbeam, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k251829/ 2025-12-08 monthly 0.8 https://www.510kdatabase.net/og-image/k251829-degen-medical-patient-specific-implant-fda-510k.jpg K251829 - DeGen Medical Patient Specific Implant (PSI) System K251829 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Degen Medical. Cleared Dec 2025. https://www.510kdatabase.net/k251936/ 2025-12-08 monthly 0.8 https://www.510kdatabase.net/og-image/k251936-ceribell-delirium-monitor-system-fda-510k.jpg K251936 - Ceribell Delirium Monitor System K251936 is a FDA 510(k) cleared neurology medical device. Manufacturer: Ceribell, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k252294/ 2025-12-08 monthly 0.8 https://www.510kdatabase.net/og-image/k252294-fetal-echoscan-v12-fda-510k.jpg K252294 - Fetal EchoScan (v1.2) K252294 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brightheart. Cleared Dec 2025. https://www.510kdatabase.net/k252789/ 2025-12-08 monthly 0.8 https://www.510kdatabase.net/og-image/k252789-glass-ceramic-fda-510k.jpg K252789 - Glass Ceramic K252789 is a FDA 510(k) cleared dental medical device. Manufacturer: Shenzhen Xiangtong Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k252862/ 2025-12-08 monthly 0.8 https://www.510kdatabase.net/og-image/k252862-electric-wheelchair-dh01126-fda-510k.jpg K252862 - Electric Wheelchair (DH01126) K252862 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Foshan Dahao Medical Technology Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k252994/ 2025-12-08 monthly 0.8 https://www.510kdatabase.net/og-image/k252994-led-therapy-mask-sr11cm-sr11cm1-fda-510k.jpg K252994 - LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7, SR11CM8) K252994 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Guangdong Ace-Tec Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k243438/ 2025-12-05 monthly 0.8 https://www.510kdatabase.net/og-image/k243438-memo-patch-m-mpt-e08r-unc01-fda-510k.jpg K243438 - MEMO Patch M (MPT-E08R-UNC01) K243438 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Huinno Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k250512/ 2025-12-05 monthly 0.8 https://www.510kdatabase.net/og-image/k250512-augmented-gingival-matrix-fda-510k.jpg K250512 - Augmented Gingival Matrix K250512 is a FDA 510(k) cleared dental medical device. Manufacturer: Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k250711/ 2025-12-05 monthly 0.8 https://www.510kdatabase.net/og-image/k250711-vsp-orthopedics-system-fda-510k.jpg K250711 - VSP Orthopedics System K250711 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 3D Systems, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k250743/ 2025-12-05 monthly 0.8 https://www.510kdatabase.net/og-image/k250743-remvia-nightguard-fda-510k.jpg K250743 - Remvia NightGuard K250743 is a FDA 510(k) cleared dental medical device. Manufacturer: Remvia. Cleared Dec 2025. https://www.510kdatabase.net/k250764/ 2025-12-05 monthly 0.8 https://www.510kdatabase.net/og-image/k250764-spinelinc-anterior-cervical-implant-fda-510k.jpg K250764 - SpineLinc Anterior Cervical Implant System K250764 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Lincotek Medical. Cleared Dec 2025. https://www.510kdatabase.net/k250780/ 2025-12-05 monthly 0.8 https://www.510kdatabase.net/og-image/k250780-artassistant-fda-510k.jpg K250780 - ARTAssistant K250780 is a FDA 510(k) cleared radiology medical device. Manufacturer: Manteia Technologies Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k250795/ 2025-12-05 monthly 0.8 https://www.510kdatabase.net/og-image/k250795-purevue-fms-fda-510k.jpg K250795 - PUREVUE™ FMS K250795 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: W.O.M. World of Medicine GmbH. Cleared Dec 2025. https://www.510kdatabase.net/k251337/ 2025-12-05 monthly 0.8 https://www.510kdatabase.net/og-image/k251337-thermo-scientific-oxoid-gepotidacin-fda-510k.jpg K251337 - Thermo Scientific Oxoid Gepotidacin Disc (10 µg) GEP10 K251337 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Thermo Fisher Scientific (Oxoid Ltd.). Cleared Dec 2025. https://www.510kdatabase.net/k251403/ 2025-12-05 monthly 0.8 https://www.510kdatabase.net/og-image/k251403-dornier-bi-polar-electrode-bip12clm-fda-510k.jpg K251403 - Dornier Bi-Polar Electrode BIP12CLM Bipolar 12° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP12CLL Bipolar 12° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLM Bipolar 30° Medium Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIP30CLL Bipolar 30° Large Cutting Loop 24 Fr Electrode-Sterile, Single-Use BIPMBLA Bipolar Medium Bladder Loop 24 Fr Electrode-Sterile, Single-Use BIPNEEL Bipolar Needle 24 Fr Electrode-Sterile, Single-Use BIPDDSC Bipolar Disc ) K251403 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Dornier Medtech America Inc (Dmta). Cleared Dec 2025. https://www.510kdatabase.net/k251514/ 2025-12-05 monthly 0.8 https://www.510kdatabase.net/og-image/k251514-overjet-cbct-assist-fda-510k.jpg K251514 - Overjet CBCT Assist K251514 is a FDA 510(k) cleared radiology medical device. Manufacturer: Overjet, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k251657/ 2025-12-05 monthly 0.8 https://www.510kdatabase.net/og-image/k251657-personalized-therapy-comfort-settings-fda-510k.jpg K251657 - Personalized Therapy Comfort Settings (PTCS) K251657 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: ResMed Corp. Cleared Dec 2025. https://www.510kdatabase.net/k251722/ 2025-12-05 monthly 0.8 https://www.510kdatabase.net/og-image/k251722-proseal-transfer-injector-421120-fda-510k.jpg K251722 - ProSeal™ Transfer Injector (421120, 421130, 421140) K251722 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Epic Medical Pte. , Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k251731/ 2025-12-05 monthly 0.8 https://www.510kdatabase.net/og-image/k251731-karl-storz-flexible-intubation-video-fda-510k.jpg K251731 - KARL STORZ Flexible Intubation Video Endoscope – Sterile (FIVE-S) (0916612) K251731 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Karl Storz SE & CO. KG. Cleared Dec 2025. https://www.510kdatabase.net/k252067/ 2025-12-05 monthly 0.8 https://www.510kdatabase.net/og-image/k252067-velora-acetabular-system-fda-510k.jpg K252067 - Velora Acetabular System K252067 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Restor3D, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k252142/ 2025-12-05 monthly 0.8 https://www.510kdatabase.net/og-image/k252142-multi-functional-facial-beauty-device-fda-510k.jpg K252142 - Multi-functional Facial Beauty Device (SKB-1703,SKB-1803,SKB-1809, SKB-1909, SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) K252142 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Siken 3D Technology Development Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k252151/ 2025-12-05 monthly 0.8 https://www.510kdatabase.net/og-image/k252151-els-unibond-fda-510k.jpg K252151 - els unibond K252151 is a FDA 510(k) cleared dental medical device. Manufacturer: Saremco Dental AG. Cleared Dec 2025. https://www.510kdatabase.net/k252296/ 2025-12-05 monthly 0.8 https://www.510kdatabase.net/og-image/k252296-oncopatch-fda-510k.jpg K252296 - OncoPatch K252296 is a FDA 510(k) cleared radiology medical device. Manufacturer: Oncopatch, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k252465/ 2025-12-05 monthly 0.8 https://www.510kdatabase.net/og-image/k252465-any-core-fda-510k.jpg K252465 - Any-Core K252465 is a FDA 510(k) cleared dental medical device. Manufacturer: Mediclus Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k252494/ 2025-12-05 monthly 0.8 https://www.510kdatabase.net/og-image/k252494-electrically-powered-wheelchair-kz301b-fda-510k.jpg K252494 - Electrically powered wheelchair (KZ301B) K252494 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Nanjing Kangni Smart Technology Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k252498/ 2025-12-05 monthly 0.8 https://www.510kdatabase.net/og-image/k252498-digital-color-doppler-ultrasound-fda-510k.jpg K252498 - Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11 Super/X11 Senior/X11/E11/E11 Pro/E11 Plus/E11 Elite/X11T/X11U/X11R/X11i/X11s/E11T/E11i/E11s/XR1/XR2/ XR3/ER1/ER2/ER3/X10 Exp/X10 Elite/X10 Pro/X10 Plus/X10 Super/X10 Senior/X10/X10T/X10U/ X10R/X10i/X10s/E10/E10 Pro/E10 Plus/E10T/E10i/E10s/SU11A EXP/SU11A PRO/SU11A AD/ SU11A CU/SU11B EXP/SU11B PRO/SU11B AD/SU11B CU/SU11C EXP/SU11C PRO/SU11C AD/ SU11C CU) K252498 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sonoscape Medical Corp.. Cleared Dec 2025. https://www.510kdatabase.net/k252504/ 2025-12-05 monthly 0.8 https://www.510kdatabase.net/og-image/k252504-gastric-alimetry-fda-510k.jpg K252504 - Gastric Alimetry K252504 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Alimetry , Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k252605/ 2025-12-05 monthly 0.8 https://www.510kdatabase.net/og-image/k252605-mcompass-anorectal-balloon-expulsion-fda-510k.jpg K252605 - mcompass Anorectal Balloon Expulsion Catheter (RMD-003-001) K252605 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medspira, LLC. Cleared Dec 2025. https://www.510kdatabase.net/k252825/ 2025-12-05 monthly 0.8 https://www.510kdatabase.net/og-image/k252825-manual-wheelchair-w45-fda-510k.jpg K252825 - Manual Wheelchair (W45) K252825 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Jiangsu Jumao X-Care Medical Equipment Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k252828/ 2025-12-05 monthly 0.8 https://www.510kdatabase.net/og-image/k252828-manual-wheelchair-w47-fda-510k.jpg K252828 - Manual Wheelchair (W47) K252828 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Jiangsu Jumao X-Care Medical Equipment Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k252841/ 2025-12-05 monthly 0.8 https://www.510kdatabase.net/og-image/k252841-real-intelligence-cori-xt-cori-xt-fda-510k.jpg K252841 - REAL INTELLIGENCE™ CORI™ XT (CORI XT) K252841 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Blue Belt Technologies, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k253868/ 2025-12-05 monthly 0.8 https://www.510kdatabase.net/og-image/k253868-quietlab-pro-fda-510k.jpg K253868 - QuietLab Pro K253868 is a FDA 510(k) cleared dental medical device. Manufacturer: QuietLab, LLC. Cleared Dec 2025. https://www.510kdatabase.net/k250679/ 2025-12-04 monthly 0.8 https://www.510kdatabase.net/og-image/k250679-ffx-facet-fixation-system-fda-510k.jpg K250679 - FFX Facet Fixation System K250679 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Sc Medica. Cleared Dec 2025. https://www.510kdatabase.net/k250791/ 2025-12-04 monthly 0.8 https://www.510kdatabase.net/og-image/k250791-asus-ultrasound-imaging-system-lu800-fda-510k.jpg K250791 - ASUS Ultrasound Imaging System (LU800 series) K250791 is a FDA 510(k) cleared radiology medical device. Manufacturer: Asustek Computer, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k250816/ 2025-12-04 monthly 0.8 https://www.510kdatabase.net/og-image/k250816-advia-centaur-anti-thyroglobulin-ii-fda-510k.jpg K250816 - ADVIA Centaur Anti-Thyroglobulin II (aTgII) K250816 is a FDA 510(k) cleared immunology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k251257/ 2025-12-04 monthly 0.8 https://www.510kdatabase.net/og-image/k251257-nset-stabilization-set-6426733-fda-510k.jpg K251257 - nSet+ Stabilization Set [6426733] K251257 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Np Medical. Cleared Dec 2025. https://www.510kdatabase.net/k251943/ 2025-12-04 monthly 0.8 https://www.510kdatabase.net/og-image/k251943-spineology-navigation-instruments-fda-510k.jpg K251943 - Spineology Navigation Instruments K251943 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spineology, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k252126/ 2025-12-04 monthly 0.8 https://www.510kdatabase.net/og-image/k252126-mitrapatch-mitral-valve-repair-system-fda-510k.jpg K252126 - MitraPatch Mitral Valve Repair System K252126 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Chawla Heart Technologies, LLC. Cleared Dec 2025. https://www.510kdatabase.net/k252429/ 2025-12-04 monthly 0.8 https://www.510kdatabase.net/og-image/k252429-vektor-computational-ecg-mapping-fda-510k.jpg K252429 - Vektor Computational ECG Mapping System (vMap®) K252429 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vektor Medical, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k252588/ 2025-12-04 monthly 0.8 https://www.510kdatabase.net/og-image/k252588-mobility-scooter-t5-fda-510k.jpg K252588 - Mobility Scooter (T5) K252588 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zhejiang Taotao Vehicle Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k252596/ 2025-12-04 monthly 0.8 https://www.510kdatabase.net/og-image/k252596-tigon-medical-knotless-and-dual-fda-510k.jpg K252596 - Tigon Medical Knotless and Dual Javelin All-Suture Anchors K252596 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tigon Medical. Cleared Dec 2025. https://www.510kdatabase.net/k250564/ 2025-12-03 monthly 0.8 https://www.510kdatabase.net/og-image/k250564-surgical-gown-level-3-s-m-l-xl-xxl-xxxl-fda-510k.jpg K250564 - Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) K250564 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Yadu Medical (Henan) Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k250692/ 2025-12-03 monthly 0.8 https://www.510kdatabase.net/og-image/k250692-gentlebeam-gb1000-fda-510k.jpg K250692 - GentleBeam (GB1000) K250692 is a FDA 510(k) cleared radiology medical device. Manufacturer: Voxel Ray Solutions, LLC. Cleared Dec 2025. https://www.510kdatabase.net/k250725/ 2025-12-03 monthly 0.8 https://www.510kdatabase.net/og-image/k250725-hugo-ras-system-fda-510k.jpg K250725 - Hugo™ RAS System K250725 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien, LLC. Cleared Dec 2025. https://www.510kdatabase.net/k251203/ 2025-12-03 monthly 0.8 https://www.510kdatabase.net/og-image/k251203-aview-lung-nodule-cad-fda-510k.jpg K251203 - AVIEW Lung Nodule CAD K251203 is a FDA 510(k) cleared radiology medical device. Manufacturer: Coreline Soft Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k251601/ 2025-12-03 monthly 0.8 https://www.510kdatabase.net/og-image/k251601-hepatus-7hepatus-6hepatus-5hepatus-fda-510k.jpg K251601 - Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous 6/Fibrous 5 Diagnostic UltrasoundSystem K251601 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k251779/ 2025-12-03 monthly 0.8 https://www.510kdatabase.net/og-image/k251779-omnipod-5-algorithm-fda-510k.jpg K251779 - Omnipod 5 algorithm K251779 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Insulet Corporation. Cleared Dec 2025. https://www.510kdatabase.net/k251881/ 2025-12-03 monthly 0.8 https://www.510kdatabase.net/og-image/k251881-hippomind-v10-fda-510k.jpg K251881 - HippoMind (v1.0) K251881 is a FDA 510(k) cleared neurology medical device. Manufacturer: Hippoclinic. Cleared Dec 2025. https://www.510kdatabase.net/k252213/ 2025-12-03 monthly 0.8 https://www.510kdatabase.net/og-image/k252213-bendit17-microcatheter-fda-510k.jpg K252213 - Bendit17 Microcatheter K252213 is a FDA 510(k) cleared neurology medical device. Manufacturer: Bend IT Technologies, Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k253293/ 2025-12-03 monthly 0.8 https://www.510kdatabase.net/og-image/k253293-vitalojak-clinic-model-7100-fda-510k.jpg K253293 - VitaloJAK Clinic (Model 7100) K253293 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Vitalograph , Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k250884/ 2025-12-02 monthly 0.8 https://www.510kdatabase.net/og-image/k250884-09-sodium-chloride-injection-usp-bd-fda-510k.jpg K250884 - 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe K250884 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson and Company. Cleared Dec 2025. https://www.510kdatabase.net/k250896/ 2025-12-02 monthly 0.8 https://www.510kdatabase.net/og-image/k250896-aura-wave-fda-510k.jpg K250896 - Aura Wave K250896 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Aura Wellness, LLC. Cleared Dec 2025. https://www.510kdatabase.net/k252021/ 2025-12-02 monthly 0.8 https://www.510kdatabase.net/og-image/k252021-disposable-endoscopic-injection-needles-fda-510k.jpg K252021 - Disposable Endoscopic Injection Needles K252021 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Changzhou New Med Micro-Medtech Co., Ltd.. Cleared Dec 2025. https://www.510kdatabase.net/k252069/ 2025-12-02 monthly 0.8 https://www.510kdatabase.net/og-image/k252069-da-vinci-sp-surgical-system-sp1098-fda-510k.jpg K252069 - da Vinci SP Surgical System (SP1098) K252069 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k252103/ 2025-12-02 monthly 0.8 https://www.510kdatabase.net/og-image/k252103-acorn-3d-software-ac-seg-4009-fda-510k.jpg K252103 - Acorn 3D Software (AC-SEG-4009) K252103 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mighty Oak Medical. Cleared Dec 2025. https://www.510kdatabase.net/k250713/ 2025-12-01 monthly 0.8 https://www.510kdatabase.net/og-image/k250713-equinoxe-humeral-reconstruction-fda-510k.jpg K250713 - Equinoxe® Humeral Reconstruction Prosthesis K250713 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k251370/ 2025-12-01 monthly 0.8 https://www.510kdatabase.net/og-image/k251370-cartesion-prime-pcd-1000a3-v1021-fda-510k.jpg K251370 - Cartesion Prime (PCD-1000A/3) V10.21 K251370 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Dec 2025. https://www.510kdatabase.net/k251691/ 2025-12-01 monthly 0.8 https://www.510kdatabase.net/og-image/k251691-unimed-reusable-spo2-sensors-08-series-fda-510k.jpg K251691 - Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08) K251691 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Unimed Medical Supplies, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k251696/ 2025-12-01 monthly 0.8 https://www.510kdatabase.net/og-image/k251696-unimed-reusable-spo2-sensors-48-series-fda-510k.jpg K251696 - Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48) K251696 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Unimed Medical Supplies, Inc.. Cleared Dec 2025. https://www.510kdatabase.net/k252786/ 2025-12-01 monthly 0.8 https://www.510kdatabase.net/og-image/k252786-led-light-phototherapy-bed-pro-450-gy-fda-510k.jpg K252786 - Led Light Phototherapy Bed (Pro 450/ GY-680A) K252786 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Suyzeko Limited.. Cleared Dec 2025. https://www.510kdatabase.net/k252827/ 2025-12-01 monthly 0.8 https://www.510kdatabase.net/og-image/k252827-ibp-cable-becton-dickinson-2606488-fda-510k.jpg K252827 - IBP cable Becton Dickinson (2606488) K252827 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Dr?gerwerk AG & Co KGaA. Cleared Dec 2025. https://www.510kdatabase.net/k253250/ 2025-12-01 monthly 0.8 https://www.510kdatabase.net/og-image/k253250-minuteman-g6-mis-fusion-plate-fda-510k.jpg K253250 - Minuteman® G6 MIS Fusion Plate K253250 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinal Simplicity, LLC. Cleared Dec 2025. https://www.510kdatabase.net/k250636/ 2025-11-28 monthly 0.8 https://www.510kdatabase.net/og-image/k250636-sophy-mini-monopressure-valve-sm1-fda-510k.jpg K250636 - Sophy Mini Monopressure Valve (SM1) K250636 is a FDA 510(k) cleared neurology medical device. Manufacturer: Sophysa. Cleared Nov 2025. https://www.510kdatabase.net/k252217/ 2025-11-28 monthly 0.8 https://www.510kdatabase.net/og-image/k252217-ct-vscore-fda-510k.jpg K252217 - CT VScore+ K252217 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Informatics, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k252658/ 2025-11-28 monthly 0.8 https://www.510kdatabase.net/og-image/k252658-medical-diode-laser-systems-tr-b-fda-510k.jpg K252658 - Medical Diode Laser Systems (TR-B) K252658 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Baoding Te'Anzhou Electronic Technology Co., Ltd.. Cleared Nov 2025. https://www.510kdatabase.net/k253303/ 2025-11-28 monthly 0.8 https://www.510kdatabase.net/og-image/k253303-dendrite-imaging-system-fda-510k.jpg K253303 - Dendrite Imaging System K253303 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Dendrite Imaging, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k252760/ 2025-11-27 monthly 0.8 https://www.510kdatabase.net/og-image/k252760-carriere-motion-pro-clear-bite-corrector-fda-510k.jpg K252760 - Carriere® Motion Pro® Clear Bite Corrector K252760 is a FDA 510(k) cleared dental medical device. Manufacturer: Ortho Organizers, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k242976/ 2025-11-26 monthly 0.8 https://www.510kdatabase.net/og-image/k242976-medical-wire-fecal-transwab-liquid-fda-510k.jpg K242976 - Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device K242976 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Medical Wire & Equipment Company (Bath), Ltd.. Cleared Nov 2025. https://www.510kdatabase.net/k251058/ 2025-11-26 monthly 0.8 https://www.510kdatabase.net/og-image/k251058-tru-kidney-health-test-panel-fda-510k.jpg K251058 - Tru Kidney Health Test Panel K251058 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Truvian Health. Cleared Nov 2025. https://www.510kdatabase.net/k251674/ 2025-11-26 monthly 0.8 https://www.510kdatabase.net/og-image/k251674-fenom-flo-feno-monitoring-system-fda-510k.jpg K251674 - Fenom Flo™ FeNO Monitoring System K251674 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Mgc Diagnostics Corporation. Cleared Nov 2025. https://www.510kdatabase.net/k251697/ 2025-11-26 monthly 0.8 https://www.510kdatabase.net/og-image/k251697-flowflex-plus-strep-a-rapid-test-fda-510k.jpg K251697 - Flowflex® Plus Strep A Rapid Test Cassette K251697 is a FDA 510(k) cleared microbiology medical device. Manufacturer: ACON Laboratories, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k252000/ 2025-11-26 monthly 0.8 https://www.510kdatabase.net/og-image/k252000-udr-arria-udr-aris-fda-510k.jpg K252000 - uDR Arria & uDR Aris K252000 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Nov 2025. https://www.510kdatabase.net/k252248/ 2025-11-26 monthly 0.8 https://www.510kdatabase.net/og-image/k252248-cerec-tessera-abutment-system-fda-510k.jpg K252248 - CEREC Tessera Abutment System K252248 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona. Cleared Nov 2025. https://www.510kdatabase.net/k252260/ 2025-11-26 monthly 0.8 https://www.510kdatabase.net/og-image/k252260-relieev-hsg-catheter-hsg7fa1-fda-510k.jpg K252260 - RELIEEV HSG Catheter (HSG7FA1) K252260 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Li Medical Corporation , Ltd.. Cleared Nov 2025. https://www.510kdatabase.net/k252355/ 2025-11-26 monthly 0.8 https://www.510kdatabase.net/og-image/k252355-k-shield-advantage-port-access-fda-510k.jpg K252355 - K-SHIELD Advantage PORT ACCESS INFUSION SET With High Pressure Tubing K252355 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sb-Kawasumi Laboratories, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k252388/ 2025-11-26 monthly 0.8 https://www.510kdatabase.net/og-image/k252388-vanquish-water-vapor-ablation-device-fda-510k.jpg K252388 - Vanquish Water Vapor Ablation Device K252388 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Francis Medical, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k252405/ 2025-11-26 monthly 0.8 https://www.510kdatabase.net/og-image/k252405-medline-renewal-reprocessed-boston-fda-510k.jpg K252405 - Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter K252405 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Surgical Instrument Service and Savings, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k253168/ 2025-11-26 monthly 0.8 https://www.510kdatabase.net/og-image/k253168-0014-willow-guidewire-fda-510k.jpg K253168 - 0.014” Willow Guidewire K253168 is a FDA 510(k) cleared neurology medical device. Manufacturer: Arbor Endovascular, LLC. Cleared Nov 2025. https://www.510kdatabase.net/k253269/ 2025-11-26 monthly 0.8 https://www.510kdatabase.net/og-image/k253269-oec-one-cfd-fda-510k.jpg K253269 - OEC One CFD K253269 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Hualun Medical Systems Co. , Ltd.. Cleared Nov 2025. https://www.510kdatabase.net/den240077/ 2025-11-26 monthly 0.8 https://www.510kdatabase.net/og-image/den240077-mureva-om-fda-510k.jpg DEN240077 - MuReva OM™ DEN240077 is a FDA 510(k) cleared dental medical device. Manufacturer: Mureva Phototherapy, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k250635/ 2025-11-25 monthly 0.8 https://www.510kdatabase.net/og-image/k250635-feops-heartguide-simulation-application-fda-510k.jpg K250635 - FEops HEARTguide Simulation Application K250635 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Feops NV. Cleared Nov 2025. https://www.510kdatabase.net/k250694/ 2025-11-25 monthly 0.8 https://www.510kdatabase.net/og-image/k250694-scaida-brainct-ich-v10-fda-510k.jpg K250694 - Scaida BrainCT-ICH (v1.0) K250694 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mlhealth 360. Cleared Nov 2025. https://www.510kdatabase.net/k251070/ 2025-11-25 monthly 0.8 https://www.510kdatabase.net/og-image/k251070-akura-thrombectomy-system-fda-510k.jpg K251070 - Akura Thrombectomy System K251070 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Akura Medical. Cleared Nov 2025. https://www.510kdatabase.net/k251401/ 2025-11-25 monthly 0.8 https://www.510kdatabase.net/og-image/k251401-pennpet-explorer-positron-emission-fda-510k.jpg K251401 - PennPET Explorer Positron Emission Tomograph K251401 is a FDA 510(k) cleared radiology medical device. Manufacturer: Trustees of the University of Pennsylvania. Cleared Nov 2025. https://www.510kdatabase.net/k251550/ 2025-11-25 monthly 0.8 https://www.510kdatabase.net/og-image/k251550-nx01-nx01-fda-510k.jpg K251550 - NX01 (NX01) K251550 is a FDA 510(k) cleared neurology medical device. Manufacturer: Naox Technologies Sas. Cleared Nov 2025. https://www.510kdatabase.net/k251798/ 2025-11-25 monthly 0.8 https://www.510kdatabase.net/og-image/k251798-rct700-fda-510k.jpg K251798 - RCT700 K251798 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ray Co., Ltd.. Cleared Nov 2025. https://www.510kdatabase.net/k251932/ 2025-11-25 monthly 0.8 https://www.510kdatabase.net/og-image/k251932-spectra-platinum-fda-510k.jpg K251932 - Spectra Platinum K251932 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Uzinmedicare Co., Ltd.. Cleared Nov 2025. https://www.510kdatabase.net/k252004/ 2025-11-25 monthly 0.8 https://www.510kdatabase.net/og-image/k252004-encore-night-guard-fda-510k.jpg K252004 - enCore Night Guard K252004 is a FDA 510(k) cleared dental medical device. Manufacturer: Encore Guards. Cleared Nov 2025. https://www.510kdatabase.net/k252161/ 2025-11-25 monthly 0.8 https://www.510kdatabase.net/og-image/k252161-hushd-avera-fda-510k.jpg K252161 - Hushd Avera K252161 is a FDA 510(k) cleared dental medical device. Manufacturer: Good Sleep CO Pte , Ltd.. Cleared Nov 2025. https://www.510kdatabase.net/k252253/ 2025-11-25 monthly 0.8 https://www.510kdatabase.net/og-image/k252253-geistlich-mucograft-geistlich-fda-510k.jpg K252253 - Geistlich Mucograft® /Geistlich Mucograft® Seal K252253 is a FDA 510(k) cleared dental medical device. Manufacturer: Geistlich Pharma AG. Cleared Nov 2025. https://www.510kdatabase.net/k252289/ 2025-11-25 monthly 0.8 https://www.510kdatabase.net/og-image/k252289-eva-scalp-cooling-system-fda-510k.jpg K252289 - Eva Scalp Cooling System K252289 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stemtech Medical Devices Private Limited. Cleared Nov 2025. https://www.510kdatabase.net/k252555/ 2025-11-25 monthly 0.8 https://www.510kdatabase.net/og-image/k252555-medusa-orthopedics-boa-external-fda-510k.jpg K252555 - Medusa Orthopedics Boa External Fixation System K252555 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medusa Orthopedics, LLC. Cleared Nov 2025. https://www.510kdatabase.net/k252610/ 2025-11-25 monthly 0.8 https://www.510kdatabase.net/og-image/k252610-zsfab-lumbar-interbody-system-fda-510k.jpg K252610 - ZSFab Lumbar Interbody System K252610 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zsfab, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k252762/ 2025-11-25 monthly 0.8 https://www.510kdatabase.net/og-image/k252762-halo-ap-dx-fda-510k.jpg K252762 - HALO AP Dx K252762 is a FDA 510(k) cleared pathology medical device. Manufacturer: Indica Labs, LLC. Cleared Nov 2025. https://www.510kdatabase.net/k252889/ 2025-11-25 monthly 0.8 https://www.510kdatabase.net/og-image/k252889-single-use-3-lumen-needle-knife-v-kd-fda-510k.jpg K252889 - Single Use 3-Lumen Needle Knife V (KD-V441M, KD-V451M) K252889 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Medical Systems Corporation. Cleared Nov 2025. https://www.510kdatabase.net/k253219/ 2025-11-25 monthly 0.8 https://www.510kdatabase.net/og-image/k253219-leafpure-echo-lm-lpnda-fda-510k.jpg K253219 - LeafPure-Echo (LM-LPNdA) K253219 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Leaflife Technology Co., Ltd.. Cleared Nov 2025. https://www.510kdatabase.net/k253304/ 2025-11-25 monthly 0.8 https://www.510kdatabase.net/og-image/k253304-ipl-hair-removal-device-ka-10-ka-11-ka-fda-510k.jpg K253304 - IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21, KA-21C) K253304 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Dongguan Lide Electric Appliance Co., Ltd.. Cleared Nov 2025. https://www.510kdatabase.net/k253310/ 2025-11-25 monthly 0.8 https://www.510kdatabase.net/og-image/k253310-7600-ultrasound-system-mylabc25-fda-510k.jpg K253310 - 7600 Ultrasound System (MyLabC25) K253310 is a FDA 510(k) cleared radiology medical device. Manufacturer: Esaote, S.P.A.. Cleared Nov 2025. https://www.510kdatabase.net/k253344/ 2025-11-25 monthly 0.8 https://www.510kdatabase.net/og-image/k253344-bellus-q-fda-510k.jpg K253344 - BELLUS-Q K253344 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Speclipse, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k253365/ 2025-11-25 monthly 0.8 https://www.510kdatabase.net/og-image/k253365-luxcreo-flexible-partial-denture-resin-fda-510k.jpg K253365 - LuxCreo Flexible Partial Denture Resin K253365 is a FDA 510(k) cleared dental medical device. Manufacturer: LuxCreo, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k242503/ 2025-11-24 monthly 0.8 https://www.510kdatabase.net/og-image/k242503-trilly-pediatric-oxygenator-with-fda-510k.jpg K242503 - Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232) K242503 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Eurosets S.R.L. Cleared Nov 2025. https://www.510kdatabase.net/k250634/ 2025-11-24 monthly 0.8 https://www.510kdatabase.net/og-image/k250634-bcm2-body-composition-monitor-fda-510k.jpg K250634 - BCM2-Body Composition Monitor K250634 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC. Cleared Nov 2025. https://www.510kdatabase.net/k250769/ 2025-11-24 monthly 0.8 https://www.510kdatabase.net/og-image/k250769-dakota-lp-system-fda-510k.jpg K250769 - Dakota LP System K250769 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Precision Spine, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k251631/ 2025-11-24 monthly 0.8 https://www.510kdatabase.net/og-image/k251631-the-bag-manual-resuscitator-and-fda-510k.jpg K251631 - The BAG manual resuscitator and accessories K251631 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Laerdal Medical AS. Cleared Nov 2025. https://www.510kdatabase.net/k252328/ 2025-11-24 monthly 0.8 https://www.510kdatabase.net/og-image/k252328-voluson-expert-18-fda-510k.jpg K252328 - Voluson Expert 18 K252328 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared Nov 2025. https://www.510kdatabase.net/k252366/ 2025-11-24 monthly 0.8 https://www.510kdatabase.net/og-image/k252366-a2z-unified-triage-fda-510k.jpg K252366 - a2z-Unified-Triage K252366 is a FDA 510(k) cleared radiology medical device. Manufacturer: A2z Radiology Ai, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k252509/ 2025-11-24 monthly 0.8 https://www.510kdatabase.net/og-image/k252509-alphavac-multipurpose-mechanical-fda-510k.jpg K252509 - AlphaVac Multipurpose Mechanical Aspiration System F1885 K252509 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: AngioDynamics, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k252688/ 2025-11-24 monthly 0.8 https://www.510kdatabase.net/og-image/k252688-transcutaneous-electrical-nerve-fda-510k.jpg K252688 - Transcutaneous Electrical Nerve Stimulator (RJTENS-2) K252688 is a FDA 510(k) cleared neurology medical device. Manufacturer: Bozhou Rongjian Medical Appliance Co., Ltd.. Cleared Nov 2025. https://www.510kdatabase.net/k252704/ 2025-11-24 monthly 0.8 https://www.510kdatabase.net/og-image/k252704-f-care-rf-system-00medrf4000us-fda-510k.jpg K252704 - F Care RF System (00MEDRF4000US, 05RAFAELOPROBE, 05SPHERAPROBE, 06OUTPUTKAB, 06Pedal1St) K252704 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: F Care Systems USA, LLC. Cleared Nov 2025. https://www.510kdatabase.net/k252771/ 2025-11-24 monthly 0.8 https://www.510kdatabase.net/og-image/k252771-holmium-laser-system-potent-hp90-fda-510k.jpg K252771 - Holmium Laser System (Potent HP90) K252771 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.. Cleared Nov 2025. https://www.510kdatabase.net/k252787/ 2025-11-24 monthly 0.8 https://www.510kdatabase.net/og-image/k252787-thulium-fiber-laser-system-tfl-a-fda-510k.jpg K252787 - Thulium Fiber Laser System (TFL-A) K252787 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.. Cleared Nov 2025. https://www.510kdatabase.net/k253407/ 2025-11-24 monthly 0.8 https://www.510kdatabase.net/og-image/k253407-neva-pv-thrombectomy-device-fda-510k.jpg K253407 - NeVa PV Thrombectomy Device K253407 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vesalio, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k250927/ 2025-11-22 monthly 0.8 https://www.510kdatabase.net/og-image/k250927-karl-storz-cholangiography-set-fda-510k.jpg K250927 - KARL STORZ Cholangiography Set K250927 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Karl Storz SE & CO. KG. Cleared Nov 2025. https://www.510kdatabase.net/k250560/ 2025-11-21 monthly 0.8 https://www.510kdatabase.net/og-image/k250560-bee-ha-fda-510k.jpg K250560 - BEE HA K250560 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: NGMedical GmbH. Cleared Nov 2025. https://www.510kdatabase.net/k250586/ 2025-11-21 monthly 0.8 https://www.510kdatabase.net/og-image/k250586-prospera-spectruum-negative-pressure-fda-510k.jpg K250586 - Prospera Spectruum Negative Pressure Wound Therapy Black Foam Kits and White Foam Accessory K250586 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Deroyal Industries, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k250700/ 2025-11-21 monthly 0.8 https://www.510kdatabase.net/og-image/k250700-pen-injector-needle-325-fda-510k.jpg K250700 - Pen Injector Needle 32.5 K250700 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terumo Corporation. Cleared Nov 2025. https://www.510kdatabase.net/k250714/ 2025-11-21 monthly 0.8 https://www.510kdatabase.net/og-image/k250714-fluorodose-varnish-fda-510k.jpg K250714 - FluoroDose Varnish K250714 is a FDA 510(k) cleared dental medical device. Manufacturer: Centrix, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k251205/ 2025-11-21 monthly 0.8 https://www.510kdatabase.net/og-image/k251205-atlantis-abutments-in-titanium-for-fda-510k.jpg K251205 - Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants K251205 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona. Cleared Nov 2025. https://www.510kdatabase.net/k251293/ 2025-11-21 monthly 0.8 https://www.510kdatabase.net/og-image/k251293-cardiovision-fda-510k.jpg K251293 - CardioVision K251293 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Icardio.Ai. Cleared Nov 2025. https://www.510kdatabase.net/k251506/ 2025-11-21 monthly 0.8 https://www.510kdatabase.net/og-image/k251506-nelli-version-711-fda-510k.jpg K251506 - Nelli (Version 7.11) K251506 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neuro Event Labs OY. Cleared Nov 2025. https://www.510kdatabase.net/k251607/ 2025-11-21 monthly 0.8 https://www.510kdatabase.net/og-image/k251607-oxygen-concentrator-j5a-fda-510k.jpg K251607 - Oxygen Concentrator (J5A) K251607 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Foshan Kycare Medical Equipment Co., Ltd.. Cleared Nov 2025. https://www.510kdatabase.net/k251849/ 2025-11-21 monthly 0.8 https://www.510kdatabase.net/og-image/k251849-staclear-syringe-sc250an-fda-510k.jpg K251849 - StaClear Syringe (SC250AN) K251849 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Staclear, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k251856/ 2025-11-21 monthly 0.8 https://www.510kdatabase.net/og-image/k251856-li-battery-powered-otc-tensems-fda-510k.jpg K251856 - Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 K251856 is a FDA 510(k) cleared neurology medical device. Manufacturer: Everyway Medical Instruments Co.,Ltd. Cleared Nov 2025. https://www.510kdatabase.net/k251880/ 2025-11-21 monthly 0.8 https://www.510kdatabase.net/og-image/k251880-archy-dental-imaging-fda-510k.jpg K251880 - Archy Dental Imaging K251880 is a FDA 510(k) cleared radiology medical device. Manufacturer: Archy Dental, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k252070/ 2025-11-21 monthly 0.8 https://www.510kdatabase.net/og-image/k252070-ceribell-infant-seizure-detection-fda-510k.jpg K252070 - Ceribell Infant Seizure Detection Software K252070 is a FDA 510(k) cleared neurology medical device. Manufacturer: Ceribell, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k252590/ 2025-11-21 monthly 0.8 https://www.510kdatabase.net/og-image/k252590-powered-mobility-scooter-pms105-gut177-fda-510k.jpg K252590 - Powered Mobility Scooter (PMS105, GUT177, GCAT047) K252590 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Intradin (Shanghai) Machinery Co., Ltd.. Cleared Nov 2025. https://www.510kdatabase.net/k252666/ 2025-11-21 monthly 0.8 https://www.510kdatabase.net/og-image/k252666-articulator-arthroscopic-bur-fda-510k.jpg K252666 - Articulator Arthroscopic Bur K252666 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Joint Preservation Innovations, LLC. Cleared Nov 2025. https://www.510kdatabase.net/k252686/ 2025-11-21 monthly 0.8 https://www.510kdatabase.net/og-image/k252686-effortmed-peek-cages-corpectomy-cages-fda-510k.jpg K252686 - EffortMed PEEK Cages & Corpectomy Cages K252686 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Effortmed, LLC. Cleared Nov 2025. https://www.510kdatabase.net/k252687/ 2025-11-21 monthly 0.8 https://www.510kdatabase.net/og-image/k252687-manual-wheelchair-hm305-air1-hm305-air2-fda-510k.jpg K252687 - Manual Wheelchair (HM305-Air1, HM305-Air2) K252687 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Suzhou Master Machinery Manufacturing Co.,Ltd. Cleared Nov 2025. https://www.510kdatabase.net/k252696/ 2025-11-21 monthly 0.8 https://www.510kdatabase.net/og-image/k252696-legacy-fda-510k.jpg K252696 - LEGACY K252696 is a FDA 510(k) cleared neurology medical device. Manufacturer: Phasor Health, LLC. Cleared Nov 2025. https://www.510kdatabase.net/k253681/ 2025-11-21 monthly 0.8 https://www.510kdatabase.net/og-image/k253681-tera-harz-hard-denture-thd-c-500-fda-510k.jpg K253681 - TERA HARZ Hard Denture (THD-C-500) K253681 is a FDA 510(k) cleared dental medical device. Manufacturer: Graphy, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k242606/ 2025-11-20 monthly 0.8 https://www.510kdatabase.net/og-image/k242606-nuvis-wireless-hd-camera-system-nuvis-2k-fda-510k.jpg K242606 - Nuvis® Wireless HD Camera System (Nuvis-2K) K242606 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Integrated Endoscopy, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k243753/ 2025-11-20 monthly 0.8 https://www.510kdatabase.net/og-image/k243753-cobas-liat-bordetella-panel-nucleic-fda-510k.jpg K243753 - cobas liat Bordetella panel nucleic acid test K243753 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Molecular Systems, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k250643/ 2025-11-20 monthly 0.8 https://www.510kdatabase.net/og-image/k250643-disposable-polymer-ligation-clips-fda-510k.jpg K250643 - Disposable Polymer Ligation Clips K250643 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Hangzhou Kangji Medical Instrument Co., Ltd.. Cleared Nov 2025. https://www.510kdatabase.net/k250963/ 2025-11-20 monthly 0.8 https://www.510kdatabase.net/og-image/k250963-planone-1-fda-510k.jpg K250963 - PlanOne 1 K250963 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cosylab Jsc, Control System Laboratory. Cleared Nov 2025. https://www.510kdatabase.net/k251365/ 2025-11-20 monthly 0.8 https://www.510kdatabase.net/og-image/k251365-optumsi-implant-system-fda-510k.jpg K251365 - OptumSI Implant System K251365 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Si Solutions, LLC. Cleared Nov 2025. https://www.510kdatabase.net/k251822/ 2025-11-20 monthly 0.8 https://www.510kdatabase.net/og-image/k251822-magnetom-freemax-fda-510k.jpg K251822 - MAGNETOM Free.Max K251822 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Shenzhen Magnetic Resonance , Ltd.. Cleared Nov 2025. https://www.510kdatabase.net/k251904/ 2025-11-20 monthly 0.8 https://www.510kdatabase.net/og-image/k251904-vascuchek-kit-vascuchek-transceiver-fda-510k.jpg K251904 - VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01) K251904 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Remington Medical, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k252625/ 2025-11-20 monthly 0.8 https://www.510kdatabase.net/og-image/k252625-the-response-ortho-smart-fixator-fda-510k.jpg K252625 - The Response Ortho Smart Fixator - Hexapod System K252625 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Response Ortho Solutions, LLC. Cleared Nov 2025. https://www.510kdatabase.net/k252846/ 2025-11-20 monthly 0.8 https://www.510kdatabase.net/og-image/k252846-taperset-hip-system-fda-510k.jpg K252846 - TaperSet™ Hip System K252846 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics. Cleared Nov 2025. https://www.510kdatabase.net/k253007/ 2025-11-20 monthly 0.8 https://www.510kdatabase.net/og-image/k253007-laser-fiber-pt-of-a-s-fda-510k.jpg K253007 - Laser Fiber (PT-OF-A-S) K253007 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.. Cleared Nov 2025. https://www.510kdatabase.net/k253070/ 2025-11-20 monthly 0.8 https://www.510kdatabase.net/og-image/k253070-namic-radial-arm-band-23-cm-dynjradband-fda-510k.jpg K253070 - Namic Radial Arm Band, 23 cm (DYNJRADBAND) K253070 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medline Industries, LP. Cleared Nov 2025. https://www.510kdatabase.net/k253105/ 2025-11-20 monthly 0.8 https://www.510kdatabase.net/og-image/k253105-hardydisk-ast-cefiderocol-30g-fdc30-fda-510k.jpg K253105 - HardyDisk AST Cefiderocol 30µg (FDC30) K253105 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Hardy Diagnostics. Cleared Nov 2025. https://www.510kdatabase.net/k253123/ 2025-11-20 monthly 0.8 https://www.510kdatabase.net/og-image/k253123-curas-hybrid-fda-510k.jpg K253123 - CuRAS hybrid K253123 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Classys, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k253190/ 2025-11-20 monthly 0.8 https://www.510kdatabase.net/og-image/k253190-corus-lx-implant-fda-510k.jpg K253190 - CORUS-LX Implant K253190 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Providence Medical Technology, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k253324/ 2025-11-20 monthly 0.8 https://www.510kdatabase.net/og-image/k253324-ultraprint-dental-denture-uv-fda-510k.jpg K253324 - UltraPrint-Dental Denture UV K253324 is a FDA 510(k) cleared dental medical device. Manufacturer: Guangzhou Heygears IMC., Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k253495/ 2025-11-20 monthly 0.8 https://www.510kdatabase.net/og-image/k253495-syngomr-applications-vb80-fda-510k.jpg K253495 - syngo.MR Applications (VB80) K253495 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Healthineers AG. Cleared Nov 2025. https://www.510kdatabase.net/k242603/ 2025-11-19 monthly 0.8 https://www.510kdatabase.net/og-image/k242603-mypao-sa-guides-fda-510k.jpg K242603 - MyPAO SA guides K242603 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Nov 2025. https://www.510kdatabase.net/k250642/ 2025-11-19 monthly 0.8 https://www.510kdatabase.net/og-image/k250642-luofucon-skin-and-wound-cleanser-spray-fda-510k.jpg K250642 - LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.) K250642 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Huizhou Foryou Medical Devices Co., Ltd.. Cleared Nov 2025. https://www.510kdatabase.net/k250651/ 2025-11-19 monthly 0.8 https://www.510kdatabase.net/og-image/k250651-optipap-junior-flexi-tube-us-optipapfus-fda-510k.jpg K250651 - OptiPAP Junior Flexi Tube US (OPTIPAPFUS) K250651 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Fisher &Paykel Healthcare , Ltd.. Cleared Nov 2025. https://www.510kdatabase.net/k250912/ 2025-11-19 monthly 0.8 https://www.510kdatabase.net/og-image/k250912-intellisep-test-fda-510k.jpg K250912 - IntelliSep Test K250912 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Cytovale, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k251910/ 2025-11-19 monthly 0.8 https://www.510kdatabase.net/og-image/k251910-focal-one-fda-510k.jpg K251910 - Focal One® K251910 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Edap Technomed, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k252642/ 2025-11-19 monthly 0.8 https://www.510kdatabase.net/og-image/k252642-microcurrent-facial-device-cec101-eei101-fda-510k.jpg K252642 - Microcurrent Facial Device (CEC101, EEI101) K252642 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Dachi Communication Co., Ltd.. Cleared Nov 2025. https://www.510kdatabase.net/k252661/ 2025-11-19 monthly 0.8 https://www.510kdatabase.net/og-image/k252661-sternafuse-ti-fixation-system-fda-510k.jpg K252661 - SternaFuse Ti Fixation System K252661 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Fusion Innovations, LLC. Cleared Nov 2025. https://www.510kdatabase.net/k252884/ 2025-11-19 monthly 0.8 https://www.510kdatabase.net/og-image/k252884-guided-aarhus-applicator-set-fda-510k.jpg K252884 - Guided Aarhus Applicator Set K252884 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems. Cleared Nov 2025. https://www.510kdatabase.net/k253035/ 2025-11-19 monthly 0.8 https://www.510kdatabase.net/og-image/k253035-ipl-hair-removal-device-syl001az-fda-510k.jpg K253035 - IPL Hair Removal Device (SYL001AZ, SYL002AZ) K253035 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Gu'An Yeolight Smart Electronics Co., Ltd.. Cleared Nov 2025. https://www.510kdatabase.net/k253073/ 2025-11-19 monthly 0.8 https://www.510kdatabase.net/og-image/k253073-led-light-therapy-device-sg-fsm-sg-nk-fda-510k.jpg K253073 - LED Light Therapy Device (SG-FSM, SG-NK, SG-CT) K253073 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sunglor Technology Co., Ltd.. Cleared Nov 2025. https://www.510kdatabase.net/k253197/ 2025-11-19 monthly 0.8 https://www.510kdatabase.net/og-image/k253197-attune-total-knee-system-fda-510k.jpg K253197 - ATTUNE™ Total Knee System K253197 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Ireland UC. Cleared Nov 2025. https://www.510kdatabase.net/k243981/ 2025-11-18 monthly 0.8 https://www.510kdatabase.net/og-image/k243981-hexoskin-medical-system-7100-00016-fda-510k.jpg K243981 - Hexoskin Medical System (7100-00016) K243981 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Carre Technologies, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k251191/ 2025-11-18 monthly 0.8 https://www.510kdatabase.net/og-image/k251191-collagen-dura-regeneration-membrane-fda-510k.jpg K251191 - Collagen Dura Regeneration Membrane - Repair K251191 is a FDA 510(k) cleared neurology medical device. Manufacturer: Collagen Matrix, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k251693/ 2025-11-18 monthly 0.8 https://www.510kdatabase.net/og-image/k251693-unimed-reusable-spo2-sensors-75-series-fda-510k.jpg K251693 - Unimed Reusable SpO2 Sensors (-75 Series) (U410-75) K251693 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Unimed Medical Supplies, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k251695/ 2025-11-18 monthly 0.8 https://www.510kdatabase.net/og-image/k251695-unimed-reusable-spo2-sensors-06-series-fda-510k.jpg K251695 - Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06) K251695 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Unimed Medical Supplies, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k252281/ 2025-11-18 monthly 0.8 https://www.510kdatabase.net/og-image/k252281-ulricheasyinject-max-2m-xd-10140-fda-510k.jpg K252281 - ulricheasyINJECT Max 2M (XD 10140) K252281 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ulrich GmbH & Co. KG. Cleared Nov 2025. https://www.510kdatabase.net/k252521/ 2025-11-18 monthly 0.8 https://www.510kdatabase.net/og-image/k252521-lifestyles-hydrafeel-natural-rubber-fda-510k.jpg K252521 - LifeStyles® HydraFeel Natural Rubber Latex Condom K252521 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Suretex Limited. Cleared Nov 2025. https://www.510kdatabase.net/k252550/ 2025-11-18 monthly 0.8 https://www.510kdatabase.net/og-image/k252550-safelife-t-cup-multi-drug-urine-test-cup-fda-510k.jpg K252550 - SAFElife T-Cup Multi-Drug Urine Test Cup K252550 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.. Cleared Nov 2025. https://www.510kdatabase.net/k252582/ 2025-11-18 monthly 0.8 https://www.510kdatabase.net/og-image/k252582-inclusive-titanium-abutments-fda-510k.jpg K252582 - Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems K252582 is a FDA 510(k) cleared dental medical device. Manufacturer: Prismatik Dentalcraft, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k252636/ 2025-11-18 monthly 0.8 https://www.510kdatabase.net/og-image/k252636-fluido-compact-system-fda-510k.jpg K252636 - Fluido Compact System K252636 is a FDA 510(k) cleared general hospital medical device. Manufacturer: The Surgical Company International B.V.. Cleared Nov 2025. https://www.510kdatabase.net/k252729/ 2025-11-18 monthly 0.8 https://www.510kdatabase.net/og-image/k252729-universal-spinal-system-fda-510k.jpg K252729 - Universal Spinal System K252729 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Double Medical Technology, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k252818/ 2025-11-18 monthly 0.8 https://www.510kdatabase.net/og-image/k252818-dexcom-smart-basal-fda-510k.jpg K252818 - Dexcom Smart Basal K252818 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dexcom, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k253411/ 2025-11-18 monthly 0.8 https://www.510kdatabase.net/og-image/k253411-miniature-telescope-for-urology-27033aa-fda-510k.jpg K253411 - Miniature Telescope for Urology (27033AA) K253411 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Karl Storz SE & CO. KG. Cleared Nov 2025. https://www.510kdatabase.net/k253423/ 2025-11-18 monthly 0.8 https://www.510kdatabase.net/og-image/k253423-toejack-mis-bunion-system-fda-510k.jpg K253423 - ToeJack MIS Bunion System K253423 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nvision Biomedical Technologies, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k250588/ 2025-11-17 monthly 0.8 https://www.510kdatabase.net/og-image/k250588-access-rubella-igg-fda-510k.jpg K250588 - Access Rubella IgG K250588 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k251141/ 2025-11-17 monthly 0.8 https://www.510kdatabase.net/og-image/k251141-powder-free-nitrile-patient-fda-510k.jpg K251141 - Powder Free Nitrile Patient Examination Glove, Blue colored, Non-sterile Tested for Use with Chemotherapy Drugs and Fentanyl Citrate K251141 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Mercator Medical (Thailand), Ltd.. Cleared Nov 2025. https://www.510kdatabase.net/k251566/ 2025-11-17 monthly 0.8 https://www.510kdatabase.net/og-image/k251566-ts-rf-generator-sts10-fda-510k.jpg K251566 - TS-RF Generator (STS10) K251566 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Starmed Co., Ltd.. Cleared Nov 2025. https://www.510kdatabase.net/k252086/ 2025-11-17 monthly 0.8 https://www.510kdatabase.net/og-image/k252086-dtx-studio-assist-fda-510k.jpg K252086 - DTX Studio Assist K252086 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nobel Biocare C/O Medicim NV. Cleared Nov 2025. https://www.510kdatabase.net/k252330/ 2025-11-17 monthly 0.8 https://www.510kdatabase.net/og-image/k252330-deepresp-fda-510k.jpg K252330 - DeepRESP K252330 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nox Medical Ehf. Cleared Nov 2025. https://www.510kdatabase.net/k252792/ 2025-11-17 monthly 0.8 https://www.510kdatabase.net/og-image/k252792-pm2-system-with-ecguide-connector-fda-510k.jpg K252792 - PM2™ System with ECGuide™ Connector K252792 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Piccolo Medical, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k253487/ 2025-11-17 monthly 0.8 https://www.510kdatabase.net/og-image/k253487-acuson-maple-diagnostic-ultrasound-fda-510k.jpg K253487 - ACUSON Maple Diagnostic Ultrasound System K253487 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k250471/ 2025-11-14 monthly 0.8 https://www.510kdatabase.net/og-image/k250471-aquac-uno-h-fda-510k.jpg K250471 - AquaC UNO H K250471 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC. Cleared Nov 2025. https://www.510kdatabase.net/k250501/ 2025-11-14 monthly 0.8 https://www.510kdatabase.net/og-image/k250501-system-sophi-fda-510k.jpg K250501 - System Sophi K250501 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: This AG. Cleared Nov 2025. https://www.510kdatabase.net/k250525/ 2025-11-14 monthly 0.8 https://www.510kdatabase.net/og-image/k250525-second-opinion-panoramic-fda-510k.jpg K250525 - Second Opinion® Panoramic K250525 is a FDA 510(k) cleared radiology medical device. Manufacturer: Pearl, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k250865/ 2025-11-14 monthly 0.8 https://www.510kdatabase.net/og-image/k250865-kls-martin-ips-forearm-system-fda-510k.jpg K250865 - KLS Martin IPS Forearm System K250865 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: KLS-Martin L.P.. Cleared Nov 2025. https://www.510kdatabase.net/k251078/ 2025-11-14 monthly 0.8 https://www.510kdatabase.net/og-image/k251078-autodensity-fda-510k.jpg K251078 - AutoDensity K251078 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eos Imaging. Cleared Nov 2025. https://www.510kdatabase.net/k251538/ 2025-11-14 monthly 0.8 https://www.510kdatabase.net/og-image/k251538-status-covid-19flu-ab-fda-510k.jpg K251538 - Status™ COVID-19/Flu A&B K251538 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Princeton BioMeditech Corp.. Cleared Nov 2025. https://www.510kdatabase.net/k251659/ 2025-11-14 monthly 0.8 https://www.510kdatabase.net/og-image/k251659-mesh-nebulizer-h6-fda-510k.jpg K251659 - Mesh Nebulizer (H6) K251659 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Qingdao Future Medical Technology Co., Ltd.. Cleared Nov 2025. https://www.510kdatabase.net/k251756/ 2025-11-14 monthly 0.8 https://www.510kdatabase.net/og-image/k251756-sterilization-trays-fda-510k.jpg K251756 - Sterilization Trays K251756 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Paragon Implant Mfg., LLC. Cleared Nov 2025. https://www.510kdatabase.net/k251821/ 2025-11-14 monthly 0.8 https://www.510kdatabase.net/og-image/k251821-arc-ex-system-fda-510k.jpg K251821 - ARC-EX System K251821 is a FDA 510(k) cleared neurology medical device. Manufacturer: Onward Medical, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k251872/ 2025-11-14 monthly 0.8 https://www.510kdatabase.net/og-image/k251872-biomoneta-avata-rx-fda-510k.jpg K251872 - Biomoneta Avata Rx K251872 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Biomoneta Research Private Limited. Cleared Nov 2025. https://www.510kdatabase.net/k252618/ 2025-11-14 monthly 0.8 https://www.510kdatabase.net/og-image/k252618-ipl-hair-removal-device-i6-s1-i6-d1-i6-fda-510k.jpg K252618 - IPL Hair Removal Device (I6 S1, I6 D1, I6 M1) K252618 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Alovea Healthcare Co. , Ltd.. Cleared Nov 2025. https://www.510kdatabase.net/k252627/ 2025-11-14 monthly 0.8 https://www.510kdatabase.net/og-image/k252627-lyme-id-igg-test-fda-510k.jpg K252627 - Lyme-ID IgG Test K252627 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Inanovate, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/den250015/ 2025-11-14 monthly 0.8 https://www.510kdatabase.net/og-image/den250015-neurolyser-xr-nxr100-fda-510k.jpg DEN250015 - Neurolyser XR (NXR100) DEN250015 is a FDA 510(k) cleared neurology medical device. Manufacturer: Fusmobile, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k251314/ 2025-11-13 monthly 0.8 https://www.510kdatabase.net/og-image/k251314-rosa-knee-system-fda-510k.jpg K251314 - Rosa® Knee System K251314 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthosoft Inc. (d/b/a) Zimmer CAS. Cleared Nov 2025. https://www.510kdatabase.net/k251662/ 2025-11-13 monthly 0.8 https://www.510kdatabase.net/og-image/k251662-air-compression-therapy-device-st-504-fda-510k.jpg K251662 - Air Compression Therapy Device (ST-504) K251662 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Shenzhen Future Electronic Co., Ltd.. Cleared Nov 2025. https://www.510kdatabase.net/k251842/ 2025-11-13 monthly 0.8 https://www.510kdatabase.net/og-image/k251842-dental-computed-tomography-x-ray-system-fda-510k.jpg K251842 - Dental Computed Tomography X-ray System K251842 is a FDA 510(k) cleared radiology medical device. Manufacturer: Fussen Technology Co., Ltd.. Cleared Nov 2025. https://www.510kdatabase.net/k252308/ 2025-11-13 monthly 0.8 https://www.510kdatabase.net/og-image/k252308-led-beauty-mask-rlbxx-fda-510k.jpg K252308 - LED Beauty Mask (RLBXX) K252308 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Atop Lighting Co., Ltd.. Cleared Nov 2025. https://www.510kdatabase.net/k252592/ 2025-11-13 monthly 0.8 https://www.510kdatabase.net/og-image/k252592-telltale-electrosurgical-guidewire-fda-510k.jpg K252592 - TELLTALE Electrosurgical Guidewire System K252592 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Telltale, LLC. Cleared Nov 2025. https://www.510kdatabase.net/k252949/ 2025-11-13 monthly 0.8 https://www.510kdatabase.net/og-image/k252949-geminus-volar-distal-radius-plating-fda-510k.jpg K252949 - Geminus Volar Distal Radius Plating System K252949 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Skeletal Dynamics, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k253457/ 2025-11-13 monthly 0.8 https://www.510kdatabase.net/og-image/k253457-acuson-juniper-diagnostic-ultrasound-fda-510k.jpg K253457 - ACUSON Juniper Diagnostic Ultrasound System K253457 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k243715/ 2025-11-12 monthly 0.8 https://www.510kdatabase.net/og-image/k243715-synthes-patient-specific-implants-fda-510k.jpg K243715 - Synthes Patient Specific Implants K243715 is a FDA 510(k) cleared neurology medical device. Manufacturer: Synthes GmbH. Cleared Nov 2025. https://www.510kdatabase.net/k243897/ 2025-11-12 monthly 0.8 https://www.510kdatabase.net/og-image/k243897-pds-plus-antibacterial-polydioxanone-fda-510k.jpg K243897 - PDS™ Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorbable Surgical Suture K243897 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k251336/ 2025-11-12 monthly 0.8 https://www.510kdatabase.net/og-image/k251336-visera-elite-iii-video-system-center-fda-510k.jpg K251336 - VISERA ELITE III Video System Center Olympus OTV-S700 (OTV-S700) K251336 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Nov 2025. https://www.510kdatabase.net/k251833/ 2025-11-12 monthly 0.8 https://www.510kdatabase.net/og-image/k251833-empowr-acetabular-liner-extension-fda-510k.jpg K251833 - EMPOWR Acetabular® Liner Extension K251833 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Encore Medical, L.P.. Cleared Nov 2025. https://www.510kdatabase.net/k252271/ 2025-11-12 monthly 0.8 https://www.510kdatabase.net/og-image/k252271-hemoclip-fda-510k.jpg K252271 - Hemoclip K252271 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hangzhou AGS MedTech Co., Ltd.. Cleared Nov 2025. https://www.510kdatabase.net/k252327/ 2025-11-12 monthly 0.8 https://www.510kdatabase.net/og-image/k252327-cmore-ct-system-fda-510k.jpg K252327 - CMORE® CT System K252327 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Icotec AG. Cleared Nov 2025. https://www.510kdatabase.net/k252452/ 2025-11-12 monthly 0.8 https://www.510kdatabase.net/og-image/k252452-peekmed-web-fda-510k.jpg K252452 - PeekMed web K252452 is a FDA 510(k) cleared radiology medical device. Manufacturer: Peek Health, S.A.. Cleared Nov 2025. https://www.510kdatabase.net/k252829/ 2025-11-12 monthly 0.8 https://www.510kdatabase.net/og-image/k252829-powered-wheelchair-pl001-9001-fda-510k.jpg K252829 - Powered Wheelchair (PL001-9001) K252829 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Suzhou KD Intelligent Device Co., Ltd.. Cleared Nov 2025. https://www.510kdatabase.net/k252959/ 2025-11-12 monthly 0.8 https://www.510kdatabase.net/og-image/k252959-wristar-multiax-distal-radius-kit-fda-510k.jpg K252959 - WRISTAR MultiAx Distal Radius Kit K252959 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Intrauma S.P.A. Cleared Nov 2025. https://www.510kdatabase.net/k253290/ 2025-11-12 monthly 0.8 https://www.510kdatabase.net/og-image/k253290-xstat-p15-fda-510k.jpg K253290 - XSTAT P15 K253290 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Revmedx, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k251006/ 2025-11-10 monthly 0.8 https://www.510kdatabase.net/og-image/k251006-nevasc-aspiration-system-fda-510k.jpg K251006 - NeVasc Aspiration System K251006 is a FDA 510(k) cleared neurology medical device. Manufacturer: Vesalio, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k251702/ 2025-11-10 monthly 0.8 https://www.510kdatabase.net/og-image/k251702-intellivue-patient-monitor-mx750-fda-510k.jpg K251702 - IntelliVue Patient Monitor MX750 K251702 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Philips Medizin Systeme B?blingen GmbH. Cleared Nov 2025. https://www.510kdatabase.net/k252287/ 2025-11-10 monthly 0.8 https://www.510kdatabase.net/og-image/k252287-symani-surgical-system-fda-510k.jpg K252287 - Symani Surgical System K252287 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medical Microinstruments, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k252474/ 2025-11-10 monthly 0.8 https://www.510kdatabase.net/og-image/k252474-withings-beamo-sct02-fda-510k.jpg K252474 - Withings BeamO (SCT02) K252474 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Withings. Cleared Nov 2025. https://www.510kdatabase.net/k252560/ 2025-11-10 monthly 0.8 https://www.510kdatabase.net/og-image/k252560-atlas-spine-hirise-expandable-cervical-fda-510k.jpg K252560 - Atlas Spine HiRISE™ Expandable Cervical Corpectomy System K252560 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Atlas Spine, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k252570/ 2025-11-10 monthly 0.8 https://www.510kdatabase.net/og-image/k252570-ezsensor-hd-ezsensor-uhd-fda-510k.jpg K252570 - EzSensor HD, EzSensor UHD K252570 is a FDA 510(k) cleared radiology medical device. Manufacturer: Qpix Solutions, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k252573/ 2025-11-10 monthly 0.8 https://www.510kdatabase.net/og-image/k252573-kls-martin-cranial-implants-mr-fda-510k.jpg K252573 - KLS Martin Cranial Implants - MR Conditional K252573 is a FDA 510(k) cleared neurology medical device. Manufacturer: KLS-Martin L.P.. Cleared Nov 2025. https://www.510kdatabase.net/k251596/ 2025-11-09 monthly 0.8 https://www.510kdatabase.net/og-image/k251596-lunderquist-extra-stiff-wire-guide-fda-510k.jpg K251596 - Lunderquist Extra Stiff Wire Guide K251596 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: William Cook Europe Aps. Cleared Nov 2025. https://www.510kdatabase.net/k243131/ 2025-11-07 monthly 0.8 https://www.510kdatabase.net/og-image/k243131-triathlon-pro-fda-510k.jpg K243131 - Triathlon Pro K243131 is a FDA 510(k) cleared neurology medical device. Manufacturer: Sigma Biomedical. Cleared Nov 2025. https://www.510kdatabase.net/k250264/ 2025-11-07 monthly 0.8 https://www.510kdatabase.net/og-image/k250264-sugarbug-1x-fda-510k.jpg K250264 - SugarBug (1.x) K250264 is a FDA 510(k) cleared radiology medical device. Manufacturer: Bench7, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k250739/ 2025-11-07 monthly 0.8 https://www.510kdatabase.net/og-image/k250739-primeprint-direct-aligner-fda-510k.jpg K250739 - Primeprint Direct Aligner K250739 is a FDA 510(k) cleared dental medical device. Manufacturer: Dreve Dentamid GmbH. Cleared Nov 2025. https://www.510kdatabase.net/k250819/ 2025-11-07 monthly 0.8 https://www.510kdatabase.net/og-image/k250819-electric-wheelchair-rollz-motion-fda-510k.jpg K250819 - Electric Wheelchair (Rollz Motion Electric 2M) K250819 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Rollz International BV. Cleared Nov 2025. https://www.510kdatabase.net/k251129/ 2025-11-07 monthly 0.8 https://www.510kdatabase.net/og-image/k251129-sin-tapered-pro-conical-zygoma-implant-fda-510k.jpg K251129 - S.I.N. Tapered Pro Conical Zygoma Implant System K251129 is a FDA 510(k) cleared dental medical device. Manufacturer: S.I.N. Implant System Ltda. Cleared Nov 2025. https://www.510kdatabase.net/k251295/ 2025-11-07 monthly 0.8 https://www.510kdatabase.net/og-image/k251295-ulrichinject-ct-motion-xd-8000-fda-510k.jpg K251295 - ulrichINJECT CT Motion (XD 8000) K251295 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ulrich GmbH & Co. KG. Cleared Nov 2025. https://www.510kdatabase.net/k251391/ 2025-11-07 monthly 0.8 https://www.510kdatabase.net/og-image/k251391-brainsway-deep-tms-system-fda-510k.jpg K251391 - BrainsWay Deep TMS System K251391 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainsway , Ltd.. Cleared Nov 2025. https://www.510kdatabase.net/k251441/ 2025-11-07 monthly 0.8 https://www.510kdatabase.net/og-image/k251441-inion-cps-15-baby-bioabsorbable-fda-510k.jpg K251441 - Inion CPS 1.5 Baby Bioabsorbable Fixation System K251441 is a FDA 510(k) cleared dental medical device. Manufacturer: Inion OY. Cleared Nov 2025. https://www.510kdatabase.net/k251853/ 2025-11-07 monthly 0.8 https://www.510kdatabase.net/og-image/k251853-consona-n5-consona-n5-pro-consona-n5-fda-510k.jpg K251853 - Consona N5, Consona N5 Pro, Consona N5 Super, Consona N5 Exp, Consona ER, Consona N5S, Consona EI, Consona EF, Consona N5 Elite, Consona N5 Ultra, Consona N3, Consona N3 Exp Diagnostic Ultrasound System K251853 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Nov 2025. https://www.510kdatabase.net/k252041/ 2025-11-07 monthly 0.8 https://www.510kdatabase.net/og-image/k252041-fibresolve-with-pccp-fda-510k.jpg K252041 - Fibresolve (with PCCP) K252041 is a FDA 510(k) cleared radiology medical device. Manufacturer: Imvaria, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k252519/ 2025-11-07 monthly 0.8 https://www.510kdatabase.net/og-image/k252519-co2-laser-therapy-system-k106-fda-510k.jpg K252519 - CO2 Laser Therapy System (K106) K252519 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Hebei Keylaser Sci-Tech Co.,Ltd. Cleared Nov 2025. https://www.510kdatabase.net/k252564/ 2025-11-07 monthly 0.8 https://www.510kdatabase.net/og-image/k252564-medical-diode-laser-systems-veincure-fda-510k.jpg K252564 - Medical Diode Laser Systems (VeinCure) K252564 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Baoding Te'Anzhou Electronic Technology Co., Ltd.. Cleared Nov 2025. https://www.510kdatabase.net/k253039/ 2025-11-07 monthly 0.8 https://www.510kdatabase.net/og-image/k253039-auto-kerato-refracto-tonometer-trk-3-fda-510k.jpg K253039 - AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA K253039 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Topcon Corporation. Cleared Nov 2025. https://www.510kdatabase.net/k253513/ 2025-11-07 monthly 0.8 https://www.510kdatabase.net/og-image/k253513-multimatch-flow-chameleon-fda-510k.jpg K253513 - MultiMatch Flow Chameleon AntiMicrobial Composite K253513 is a FDA 510(k) cleared dental medical device. Manufacturer: Premier Dental Products Company. Cleared Nov 2025. https://www.510kdatabase.net/k250423/ 2025-11-06 monthly 0.8 https://www.510kdatabase.net/og-image/k250423-mb-fix-cranial-stabilization-systems-fda-510k.jpg K250423 - mb-FIX Cranial Stabilization Systems K250423 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medical Bees GmbH. Cleared Nov 2025. https://www.510kdatabase.net/k250815/ 2025-11-06 monthly 0.8 https://www.510kdatabase.net/og-image/k250815-hubly-drill-h100-fda-510k.jpg K250815 - Hubly Drill (H100) K250815 is a FDA 510(k) cleared neurology medical device. Manufacturer: Hubly, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k251004/ 2025-11-06 monthly 0.8 https://www.510kdatabase.net/og-image/k251004-dual-mode-mobile-c-arm-geelin500a-fda-510k.jpg K251004 - Dual-Mode Mobile C-Arm (Geelin500A, Geelin500M) K251004 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hefei Chimed Intelligent Machine Co., Ltd.. Cleared Nov 2025. https://www.510kdatabase.net/k251555/ 2025-11-06 monthly 0.8 https://www.510kdatabase.net/og-image/k251555-ultra-compression-screw-system-fda-510k.jpg K251555 - Ultra™ Compression Screw System K251555 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Pace Surgical. Cleared Nov 2025. https://www.510kdatabase.net/k251792/ 2025-11-06 monthly 0.8 https://www.510kdatabase.net/og-image/k251792-stereotaxis-genesisx-rmn-with-navigant-fda-510k.jpg K251792 - Stereotaxis GenesisX RMN with Navigant ™ Workstation (NWS) K251792 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Stereotaxis, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k252133/ 2025-11-06 monthly 0.8 https://www.510kdatabase.net/og-image/k252133-adaptix-ortho350-fda-510k.jpg K252133 - Adaptix Ortho350 K252133 is a FDA 510(k) cleared radiology medical device. Manufacturer: Adaptix Limited. Cleared Nov 2025. https://www.510kdatabase.net/k252418/ 2025-11-06 monthly 0.8 https://www.510kdatabase.net/og-image/k252418-catalyst-f1x-shoulder-system-fda-510k.jpg K252418 - Catalyst F1x Shoulder System K252418 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Catalyst Orthoscience, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k252469/ 2025-11-06 monthly 0.8 https://www.510kdatabase.net/og-image/k252469-magnabond-se-fda-510k.jpg K252469 - MAGNABOND SE K252469 is a FDA 510(k) cleared dental medical device. Manufacturer: Dmp Dental Industry S.A.. Cleared Nov 2025. https://www.510kdatabase.net/k252515/ 2025-11-06 monthly 0.8 https://www.510kdatabase.net/og-image/k252515-q-switched-ndyag-laser-k690-fda-510k.jpg K252515 - Q-Switched Nd:Yag laser (K690) K252515 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Hebei Keylaser Sci-Tech Co.,Ltd. Cleared Nov 2025. https://www.510kdatabase.net/k252525/ 2025-11-06 monthly 0.8 https://www.510kdatabase.net/og-image/k252525-aio-breathe-fda-510k.jpg K252525 - AIO Breathe K252525 is a FDA 510(k) cleared dental medical device. Manufacturer: Aiomega, LLC. Cleared Nov 2025. https://www.510kdatabase.net/k252845/ 2025-11-06 monthly 0.8 https://www.510kdatabase.net/og-image/k252845-venus-nova-fp-2001-fda-510k.jpg K252845 - Venus Nova (FP-2001) K252845 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Venus Concept, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k253074/ 2025-11-06 monthly 0.8 https://www.510kdatabase.net/og-image/k253074-tandem-mobi-insulin-pump-with-fda-510k.jpg K253074 - Tandem Mobi insulin pump with interoperable technology K253074 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Tandem Diabetes Care, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k253265/ 2025-11-06 monthly 0.8 https://www.510kdatabase.net/og-image/k253265-briefcase-triage-fda-510k.jpg K253265 - BriefCase-Triage K253265 is a FDA 510(k) cleared radiology medical device. Manufacturer: Aidoc Medical , Ltd.. Cleared Nov 2025. https://www.510kdatabase.net/k253478/ 2025-11-06 monthly 0.8 https://www.510kdatabase.net/og-image/k253478-motive-muscle-stimulator-for-lower-fda-510k.jpg K253478 - Motive™ Muscle Stimulator for Lower Back (OT01-1003) K253478 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Motive Health, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k250363/ 2025-11-05 monthly 0.8 https://www.510kdatabase.net/og-image/k250363-depth-electrode-rsde-08-fda-510k.jpg K250363 - Depth Electrode (RSDE-08) K250363 is a FDA 510(k) cleared neurology medical device. Manufacturer: Beijing Sinovation Medical Technology Co., Ltd.. Cleared Nov 2025. https://www.510kdatabase.net/k250375/ 2025-11-05 monthly 0.8 https://www.510kdatabase.net/og-image/k250375-allure-hip-stem-and-intramedullary-plugs-fda-510k.jpg K250375 - Allure Hip Stem and Intramedullary Plugs K250375 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Waldemar Link GmbH & Co. KG. Cleared Nov 2025. https://www.510kdatabase.net/k250376/ 2025-11-05 monthly 0.8 https://www.510kdatabase.net/og-image/k250376-vivy-fda-510k.jpg K250376 - ViVY K250376 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Viatherm Therapeutics, LLC. Cleared Nov 2025. https://www.510kdatabase.net/k250599/ 2025-11-05 monthly 0.8 https://www.510kdatabase.net/og-image/k250599-excelsiusgps-instruments-fda-510k.jpg K250599 - ExcelsiusGPS™ Instruments K250599 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k252514/ 2025-11-05 monthly 0.8 https://www.510kdatabase.net/og-image/k252514-evac-mri-fda-510k.jpg K252514 - EVAC-MRI K252514 is a FDA 510(k) cleared neurology medical device. Manufacturer: Phasor Health, LLC. Cleared Nov 2025. https://www.510kdatabase.net/k252677/ 2025-11-05 monthly 0.8 https://www.510kdatabase.net/og-image/k252677-polyshield-safety-iv-catheters-fda-510k.jpg K252677 - Polyshield Safety IV Catheters K252677 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Poly Medicure Limited. Cleared Nov 2025. https://www.510kdatabase.net/k250241/ 2025-11-04 monthly 0.8 https://www.510kdatabase.net/og-image/k250241-cios-select-fda-510k.jpg K250241 - Cios Select K250241 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k250576/ 2025-11-04 monthly 0.8 https://www.510kdatabase.net/og-image/k250576-flexx-junior-flx-j00-flx-j50-fda-510k.jpg K250576 - Flexx Junior (FLX-J00, FLX-J50) K250576 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Karma Mobility Co, Ltd.. Cleared Nov 2025. https://www.510kdatabase.net/k250853/ 2025-11-04 monthly 0.8 https://www.510kdatabase.net/og-image/k250853-merit-syringe-fda-510k.jpg K250853 - Merit Syringe K250853 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k251303/ 2025-11-04 monthly 0.8 https://www.510kdatabase.net/og-image/k251303-tamburo-thulium-fiber-laser-system-fda-510k.jpg K251303 - Tamburo Thulium Fiber Laser System K251303 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Menovex Medical Technology (Shenzhen) Co., Ltd.. Cleared Nov 2025. https://www.510kdatabase.net/k251410/ 2025-11-04 monthly 0.8 https://www.510kdatabase.net/og-image/k251410-vxvue-fda-510k.jpg K251410 - VXvue K251410 is a FDA 510(k) cleared radiology medical device. Manufacturer: Vieworks Co., Ltd.. Cleared Nov 2025. https://www.510kdatabase.net/k251709/ 2025-11-04 monthly 0.8 https://www.510kdatabase.net/og-image/k251709-medcad-accustride-system-fda-510k.jpg K251709 - MedCAD® AccuStride™ System K251709 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medcad. Cleared Nov 2025. https://www.510kdatabase.net/k252664/ 2025-11-04 monthly 0.8 https://www.510kdatabase.net/og-image/k252664-gmreis-suture-anchors-fda-510k.jpg K252664 - GMReis Suture Anchors K252664 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: GM Dos Reis Industria e Comercio Ltda.. Cleared Nov 2025. https://www.510kdatabase.net/k252740/ 2025-11-04 monthly 0.8 https://www.510kdatabase.net/og-image/k252740-voyant-open-fusion-device-eb240open-fda-510k.jpg K252740 - Voyant® Open Fusion Device (EB240/Open Fusion) K252740 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Applied Medical Resources Corp.. Cleared Nov 2025. https://www.510kdatabase.net/k252964/ 2025-11-04 monthly 0.8 https://www.510kdatabase.net/og-image/k252964-primed-surgical-and-procedure-masks-fda-510k.jpg K252964 - PRIMED Surgical and Procedure Masks K252964 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Primed Medical Products, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k250330/ 2025-11-03 monthly 0.8 https://www.510kdatabase.net/og-image/k250330-3mensio-workstation-fda-510k.jpg K250330 - 3mensio Workstation K250330 is a FDA 510(k) cleared radiology medical device. Manufacturer: Pie Medical Imaging BV. Cleared Nov 2025. https://www.510kdatabase.net/k250392/ 2025-11-03 monthly 0.8 https://www.510kdatabase.net/og-image/k250392-zap-x-radiosurgery-system-zap-x-fda-510k.jpg K250392 - ZAP-X Radiosurgery System (ZAP-X) K250392 is a FDA 510(k) cleared radiology medical device. Manufacturer: Zap Surgical Systems, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k251532/ 2025-11-03 monthly 0.8 https://www.510kdatabase.net/og-image/k251532-acorn-3d-software-ac-seg-4009-fda-510k.jpg K251532 - Acorn 3D Software (AC-SEG-4009) K251532 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mighty Oak Medical. Cleared Nov 2025. https://www.510kdatabase.net/k251626/ 2025-11-03 monthly 0.8 https://www.510kdatabase.net/og-image/k251626-midmark-dental-delivery-system-fda-510k.jpg K251626 - Midmark Dental Delivery System K251626 is a FDA 510(k) cleared dental medical device. Manufacturer: Midmark Corporation. Cleared Nov 2025. https://www.510kdatabase.net/k252458/ 2025-11-03 monthly 0.8 https://www.510kdatabase.net/og-image/k252458-kyphoplasty-balloon-dilatation-catheters-fda-510k.jpg K252458 - Kyphoplasty Balloon Dilatation Catheters K252458 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Shanghai Lange Medtech Co., Ltd.. Cleared Nov 2025. https://www.510kdatabase.net/k252481/ 2025-11-03 monthly 0.8 https://www.510kdatabase.net/og-image/k252481-cobas-cmv-fda-510k.jpg K252481 - cobas CMV K252481 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Molecular Systems, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k252484/ 2025-11-03 monthly 0.8 https://www.510kdatabase.net/og-image/k252484-cobas-hcv-fda-510k.jpg K252484 - cobas HCV K252484 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Molecular Systems, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k252671/ 2025-11-03 monthly 0.8 https://www.510kdatabase.net/og-image/k252671-electric-wheelchair-nsds-01-fda-510k.jpg K252671 - Electric wheelchair (NSDS-01) K252671 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Hebei Dansong Medical Technology Co., Ltd.. Cleared Nov 2025. https://www.510kdatabase.net/k252698/ 2025-11-03 monthly 0.8 https://www.510kdatabase.net/og-image/k252698-nightguard-aire-max-fda-510k.jpg K252698 - NightGuard Aire Max K252698 is a FDA 510(k) cleared dental medical device. Manufacturer: Nightguard Express, LLC. Cleared Nov 2025. https://www.510kdatabase.net/k253448/ 2025-11-03 monthly 0.8 https://www.510kdatabase.net/og-image/k253448-sonosite-mt-ultrasound-system-fda-510k.jpg K253448 - Sonosite MT Ultrasound System K253448 is a FDA 510(k) cleared radiology medical device. Manufacturer: FUJIFILM Sonosite, Inc.. Cleared Nov 2025. https://www.510kdatabase.net/k250306/ 2025-10-31 monthly 0.8 https://www.510kdatabase.net/og-image/k250306-chex-all-sterilization-pouches-and-tubes-fda-510k.jpg K250306 - Chex-All Sterilization Pouches and Tubes K250306 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Propper Manufacturing Co., Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k250338/ 2025-10-31 monthly 0.8 https://www.510kdatabase.net/og-image/k250338-mss-humeral-reverse-liners-extension-fda-510k.jpg K250338 - MSS - Humeral reverse liners extension K250338 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Oct 2025. https://www.510kdatabase.net/k250358/ 2025-10-31 monthly 0.8 https://www.510kdatabase.net/og-image/k250358-bd-enteric-bacterial-panel-for-bd-cor-fda-510k.jpg K250358 - BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System K250358 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson and Company. Cleared Oct 2025. https://www.510kdatabase.net/k250917/ 2025-10-31 monthly 0.8 https://www.510kdatabase.net/og-image/k250917-flexible-ureterorenoscope-system-fda-510k.jpg K250917 - Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model: SP-TXCLQ12.1, Flexible Ureterorenoscope, model: SP-SNGSYJ 2.0, SP-SNGSYJ 2.2, SP-SNGSYJ 2.5, SP-SNGSYJ 2.8) K250917 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Shenzhen Sanping Image Technology Co., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k251041/ 2025-10-31 monthly 0.8 https://www.510kdatabase.net/og-image/k251041-griptract-gi-endoscopic-tissue-fda-510k.jpg K251041 - GripTract-GI™ Endoscopic Tissue Manipulator Upper GI Model GT-GS100 K251041 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Actuated Medical, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k251381/ 2025-10-31 monthly 0.8 https://www.510kdatabase.net/og-image/k251381-ceribell-instant-eeg-headcap-small-fda-510k.jpg K251381 - Ceribell Instant EEG Headcap (Small: C251, Medium: C252) K251381 is a FDA 510(k) cleared neurology medical device. Manufacturer: Ceribell, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k251547/ 2025-10-31 monthly 0.8 https://www.510kdatabase.net/og-image/k251547-dess-dental-smart-solutions-fda-510k.jpg K251547 - DESS Dental Smart Solutions K251547 is a FDA 510(k) cleared dental medical device. Manufacturer: Terrats Medical SL. Cleared Oct 2025. https://www.510kdatabase.net/k252060/ 2025-10-31 monthly 0.8 https://www.510kdatabase.net/og-image/k252060-green-fda-510k.jpg K252060 - GREEN K252060 is a FDA 510(k) cleared neurology medical device. Manufacturer: Phasor Health, LLC. Cleared Oct 2025. https://www.510kdatabase.net/k252074/ 2025-10-31 monthly 0.8 https://www.510kdatabase.net/og-image/k252074-aplio-i900-aplio-i800-and-aplio-i700-fda-510k.jpg K252074 - Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System K252074 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Oct 2025. https://www.510kdatabase.net/k252088/ 2025-10-31 monthly 0.8 https://www.510kdatabase.net/og-image/k252088-firebird-si-navigation-system-fda-510k.jpg K252088 - Firebird SI Navigation System K252088 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthofix US, LLC. Cleared Oct 2025. https://www.510kdatabase.net/k252160/ 2025-10-31 monthly 0.8 https://www.510kdatabase.net/og-image/k252160-persyst-15-eeg-review-and-analysis-fda-510k.jpg K252160 - Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) K252160 is a FDA 510(k) cleared neurology medical device. Manufacturer: Persyst Development, LLC. Cleared Oct 2025. https://www.510kdatabase.net/k252412/ 2025-10-31 monthly 0.8 https://www.510kdatabase.net/og-image/k252412-voyant-electrosurgical-generator-fda-510k.jpg K252412 - Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator) K252412 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Applied Medical Resources Corporation. Cleared Oct 2025. https://www.510kdatabase.net/k252427/ 2025-10-31 monthly 0.8 https://www.510kdatabase.net/og-image/k252427-diode-laser-hair-removal-machine-gld01-fda-510k.jpg K252427 - Diode Laser Hair Removal Machine (GLD01) K252427 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sanhe Meditech Co., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k252442/ 2025-10-31 monthly 0.8 https://www.510kdatabase.net/og-image/k252442-kii-structural-balloon-access-system-fda-510k.jpg K252442 - Kii Structural Balloon Access System K252442 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Applied Medical Resources Corp.. Cleared Oct 2025. https://www.510kdatabase.net/k252777/ 2025-10-31 monthly 0.8 https://www.510kdatabase.net/og-image/k252777-freedom-metaphyseal-cone-implants-fda-510k.jpg K252777 - Freedom Metaphyseal Cone Implants (Metaphyseal Cones) K252777 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Maxx Orthopedics, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k253501/ 2025-10-31 monthly 0.8 https://www.510kdatabase.net/og-image/k253501-hydro-print-premium-fast-set-454g-1lb-fda-510k.jpg K253501 - Hydro Print Premium Fast Set - 454g (1lb) (052037) K253501 is a FDA 510(k) cleared dental medical device. Manufacturer: Vigodent Ind?stria E Comercio Ltda. Cleared Oct 2025. https://www.510kdatabase.net/den240074/ 2025-10-31 monthly 0.8 https://www.510kdatabase.net/og-image/den240074-pulsenmore-es-fda-510k.jpg DEN240074 - Pulsenmore ES DEN240074 is a FDA 510(k) cleared radiology medical device. Manufacturer: Pulsenmore, Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k243619/ 2025-10-30 monthly 0.8 https://www.510kdatabase.net/og-image/k243619-niti-s-esophageal-stent-fda-510k.jpg K243619 - Niti-S Esophageal Stent K243619 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Taewoong Medical Co., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k250325/ 2025-10-30 monthly 0.8 https://www.510kdatabase.net/og-image/k250325-bd-alaris-pump-infusion-set-fda-510k.jpg K250325 - BD Alaris Pump Infusion Set K250325 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Carefusion (Bd). Cleared Oct 2025. https://www.510kdatabase.net/k250337/ 2025-10-30 monthly 0.8 https://www.510kdatabase.net/og-image/k250337-aiorta-plan-fda-510k.jpg K250337 - AiORTA - Plan K250337 is a FDA 510(k) cleared radiology medical device. Manufacturer: ViTAA Medical Solutions, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k250632/ 2025-10-30 monthly 0.8 https://www.510kdatabase.net/og-image/k250632-arctx-cool-catheter-set-fda-510k.jpg K250632 - Arctx Cool Catheter Set K250632 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Arctx Medical. Cleared Oct 2025. https://www.510kdatabase.net/k251531/ 2025-10-30 monthly 0.8 https://www.510kdatabase.net/og-image/k251531-air-compression-boots-10181951018196-fda-510k.jpg K251531 - AIR COMPRESSION BOOTS 1018195,1018196 K251531 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Merchsource, LLC. Cleared Oct 2025. https://www.510kdatabase.net/k251686/ 2025-10-30 monthly 0.8 https://www.510kdatabase.net/og-image/k251686-tornier-humeral-reconstruction-system-fda-510k.jpg K251686 - Tornier Humeral Reconstruction System Max (Tornier HRS Max) K251686 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tornier, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k251938/ 2025-10-30 monthly 0.8 https://www.510kdatabase.net/og-image/k251938-gen5-and-gen5-dental-implant-system-fda-510k.jpg K251938 - GEN5 and GEN5+ Dental Implant System K251938 is a FDA 510(k) cleared dental medical device. Manufacturer: Paragon Implant Mfg., LLC. Cleared Oct 2025. https://www.510kdatabase.net/k252046/ 2025-10-30 monthly 0.8 https://www.510kdatabase.net/og-image/k252046-zoom-system-zoom-4s-catheter-fda-510k.jpg K252046 - Zoom System (Zoom 4S Catheter) K252046 is a FDA 510(k) cleared neurology medical device. Manufacturer: Imperative Care, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k252387/ 2025-10-30 monthly 0.8 https://www.510kdatabase.net/og-image/k252387-simplexa-covid-19-flu-ab-rsv-direct-fda-510k.jpg K252387 - Simplexa™ COVID-19/ Flu A/B & RSV Direct (MOL4450) K252387 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Diasorin Molecular, LLC. Cleared Oct 2025. https://www.510kdatabase.net/k252414/ 2025-10-30 monthly 0.8 https://www.510kdatabase.net/og-image/k252414-q-renew-lllt-hair-growth-helmet-q-hlmt-fda-510k.jpg K252414 - Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1) K252414 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Kaiyan Medical Equipment Co., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k252430/ 2025-10-30 monthly 0.8 https://www.510kdatabase.net/og-image/k252430-freeprint-denture-flex-fda-510k.jpg K252430 - Freeprint® denture flex K252430 is a FDA 510(k) cleared dental medical device. Manufacturer: Detax GmbH. Cleared Oct 2025. https://www.510kdatabase.net/k252529/ 2025-10-30 monthly 0.8 https://www.510kdatabase.net/og-image/k252529-moses-200-dfl-laser-fiber-m0068130100-fda-510k.jpg K252529 - Moses™ 200 D/F/L Laser Fiber (M0068130100) K252529 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Boston Scientific Corporation. Cleared Oct 2025. https://www.510kdatabase.net/k252607/ 2025-10-30 monthly 0.8 https://www.510kdatabase.net/og-image/k252607-alltest-urinary-tract-infection-test-fda-510k.jpg K252607 - AllTest Urinary Tract Infection Test K252607 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Hangzhou AllTest Biotech Co., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k252752/ 2025-10-30 monthly 0.8 https://www.510kdatabase.net/og-image/k252752-ellacor-system-with-micro-coring-fda-510k.jpg K252752 - ellacor System with Micro-Coring Technology K252752 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cytrellis Biosystems, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k253327/ 2025-10-30 monthly 0.8 https://www.510kdatabase.net/og-image/k253327-hanarostent-esophagus-upper-ccc-fda-510k.jpg K253327 - HANAROSTENT Esophagus Upper (CCC) K253327 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: M.I. Tech Co., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k253376/ 2025-10-30 monthly 0.8 https://www.510kdatabase.net/og-image/k253376-obsidio-conformable-embolic-fda-510k.jpg K253376 - OBSIDIO™ Conformable Embolic (M0013972101010) K253376 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Oct 2025. https://www.510kdatabase.net/k250316/ 2025-10-29 monthly 0.8 https://www.510kdatabase.net/og-image/k250316-meduloc-intramedullary-fracture-fda-510k.jpg K250316 - Meduloc Intramedullary Fracture Fixation (IFF) System K250316 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Meduloc, LLC. Cleared Oct 2025. https://www.510kdatabase.net/k250618/ 2025-10-29 monthly 0.8 https://www.510kdatabase.net/og-image/k250618-medi-lift-essential-eye-mask-fda-510k.jpg K250618 - Medi Lift Essential Eye Mask K250618 is a FDA 510(k) cleared neurology medical device. Manufacturer: Ya-Man, Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k250882/ 2025-10-29 monthly 0.8 https://www.510kdatabase.net/og-image/k250882-sansa-hsat-fda-510k.jpg K250882 - SANSA HSAT K250882 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Huxley Medical. Cleared Oct 2025. https://www.510kdatabase.net/k251643/ 2025-10-29 monthly 0.8 https://www.510kdatabase.net/og-image/k251643-synchfix-evt-fda-510k.jpg K251643 - Synchfix EVT K251643 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wright Medical Technology, Inc. (Stryker Corporation). Cleared Oct 2025. https://www.510kdatabase.net/k251772/ 2025-10-29 monthly 0.8 https://www.510kdatabase.net/og-image/k251772-navilas-laser-system-577sl-156691-fda-510k.jpg K251772 - Navilas Laser System 577sl (156691) K251772 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Od-Os GmbH. Cleared Oct 2025. https://www.510kdatabase.net/k251963/ 2025-10-29 monthly 0.8 https://www.510kdatabase.net/og-image/k251963-logiq-e10s-fda-510k.jpg K251963 - LOGIQ E10s K251963 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared Oct 2025. https://www.510kdatabase.net/k251985/ 2025-10-29 monthly 0.8 https://www.510kdatabase.net/og-image/k251985-logiq-e10-fda-510k.jpg K251985 - LOGIQ E10 K251985 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared Oct 2025. https://www.510kdatabase.net/k252314/ 2025-10-29 monthly 0.8 https://www.510kdatabase.net/og-image/k252314-arthrex-suturetak-suture-anchor-fda-510k.jpg K252314 - Arthrex SutureTak Suture Anchor K252314 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k252390/ 2025-10-29 monthly 0.8 https://www.510kdatabase.net/og-image/k252390-telescope-guide-extension-catheter-fda-510k.jpg K252390 - Telescope Guide Extension Catheter K252390 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Ireland. Cleared Oct 2025. https://www.510kdatabase.net/k252393/ 2025-10-29 monthly 0.8 https://www.510kdatabase.net/og-image/k252393-vitros-immunodiagnostic-products-hs-fda-510k.jpg K252393 - VITROS Immunodiagnostic Products hs Troponin I Reagent Pack K252393 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Ortho-Clinical Diagnostics, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k252416/ 2025-10-29 monthly 0.8 https://www.510kdatabase.net/og-image/k252416-aetos-shoulder-system-meta-humeral-fda-510k.jpg K252416 - AETOS Shoulder System Meta Humeral Prosthesis Size 0 K252416 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k252697/ 2025-10-29 monthly 0.8 https://www.510kdatabase.net/og-image/k252697-3d-laparoscope-fda-510k.jpg K252697 - 3D Laparoscope K252697 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Guangdong Optomedic Technologies, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k253153/ 2025-10-29 monthly 0.8 https://www.510kdatabase.net/og-image/k253153-ser-pen-carain-microsystem-mp1209sp-fda-510k.jpg K253153 - SER Pen Carain MicroSystem (MP1209SP) K253153 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Su-Ko Technologies, LLC. Cleared Oct 2025. https://www.510kdatabase.net/k253232/ 2025-10-29 monthly 0.8 https://www.510kdatabase.net/og-image/k253232-seguin-annuloplasty-ring-fda-510k.jpg K253232 - Seguin Annuloplasty Ring K253232 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared Oct 2025. https://www.510kdatabase.net/k253242/ 2025-10-29 monthly 0.8 https://www.510kdatabase.net/og-image/k253242-lcd-monitor-c1216w-c822w-c821w-fda-510k.jpg K253242 - LCD Monitor (C1216W, C822W, C821W) K253242 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Beacon Display Technology Co., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k253283/ 2025-10-29 monthly 0.8 https://www.510kdatabase.net/og-image/k253283-momcozy-wearable-breast-pump-model-fda-510k.jpg K253283 - Momcozy Wearable Breast Pump (Model: BP334-, BP380-, BP420-, BP431-, BP400-, BP432-, BP434-) K253283 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shenzhen Root Innovation Technology Co., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k253314/ 2025-10-29 monthly 0.8 https://www.510kdatabase.net/og-image/k253314-freedom-infinia-total-knee-system-fda-510k.jpg K253314 - Freedom Infinia™ Total Knee System K253314 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Maxx Orthopedics, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k253323/ 2025-10-29 monthly 0.8 https://www.510kdatabase.net/og-image/k253323-protrieve-sheath-fda-510k.jpg K253323 - Protrieve Sheath K253323 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inari Medical. Cleared Oct 2025. https://www.510kdatabase.net/k253345/ 2025-10-29 monthly 0.8 https://www.510kdatabase.net/og-image/k253345-jarvis-diaphyseal-stem-standard-fda-510k.jpg K253345 - JARVIS Diaphyseal Stem Standard K253345 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: FH Industrie. Cleared Oct 2025. https://www.510kdatabase.net/k253355/ 2025-10-29 monthly 0.8 https://www.510kdatabase.net/og-image/k253355-difiney-advanced-anti-snoring-device-40-fda-510k.jpg K253355 - Difiney Advanced Anti Snoring Device 4.0 K253355 is a FDA 510(k) cleared dental medical device. Manufacturer: Fissiontech, LLC. Cleared Oct 2025. https://www.510kdatabase.net/k250275/ 2025-10-28 monthly 0.8 https://www.510kdatabase.net/og-image/k250275-precisepath-radiofrequency-puncture-fda-510k.jpg K250275 - PrecisePath™ Radiofrequency Puncture Generator and PrecisePath™ Footswitch K250275 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Baylis Medical Technologies, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k251466/ 2025-10-28 monthly 0.8 https://www.510kdatabase.net/og-image/k251466-venair-sequential-compression-system-fda-510k.jpg K251466 - VenAir, Sequential Compression System (9P-089000) K251466 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Wellell, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k252165/ 2025-10-28 monthly 0.8 https://www.510kdatabase.net/og-image/k252165-zirconomer-p-fda-510k.jpg K252165 - ZIRCONOMER P K252165 is a FDA 510(k) cleared dental medical device. Manufacturer: Shofu Dental Corporation. Cleared Oct 2025. https://www.510kdatabase.net/k252351/ 2025-10-28 monthly 0.8 https://www.510kdatabase.net/og-image/k252351-unispace-tplif-cage-fda-510k.jpg K252351 - UniSpace® TPLIF Cage K252351 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Cg Medtech Co., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k252376/ 2025-10-28 monthly 0.8 https://www.510kdatabase.net/og-image/k252376-yomi-s-robotic-system-fda-510k.jpg K252376 - Yomi S Robotic System K252376 is a FDA 510(k) cleared dental medical device. Manufacturer: Neocis, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k252547/ 2025-10-28 monthly 0.8 https://www.510kdatabase.net/og-image/k252547-therasphere-360-y-90-management-platform-fda-510k.jpg K252547 - TheraSphere 360™ Y-90 Management Platform K252547 is a FDA 510(k) cleared radiology medical device. Manufacturer: Boston Scientific Corporation. Cleared Oct 2025. https://www.510kdatabase.net/k252742/ 2025-10-28 monthly 0.8 https://www.510kdatabase.net/og-image/k252742-navigated-instruments-fda-510k.jpg K252742 - Navigated Instruments K252742 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tyber Medical, LLC. Cleared Oct 2025. https://www.510kdatabase.net/k253300/ 2025-10-28 monthly 0.8 https://www.510kdatabase.net/og-image/k253300-fine-osteotomy-fda-510k.jpg K253300 - Fine Osteotomy™ K253300 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Bodycad Laboratories, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k253399/ 2025-10-28 monthly 0.8 https://www.510kdatabase.net/og-image/k253399-visions-pv-014p-rx-digital-ivus-catheter-fda-510k.jpg K253399 - Visions® PV .014P RX Digital IVUS Catheter K253399 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Volcano Corporation (Dba Philips Image Guided Therapy Device. Cleared Oct 2025. https://www.510kdatabase.net/k250297/ 2025-10-27 monthly 0.8 https://www.510kdatabase.net/og-image/k250297-techfit-patient-specific-cranial-system-fda-510k.jpg K250297 - TECHFIT Patient-Specific Cranial System K250297 is a FDA 510(k) cleared neurology medical device. Manufacturer: Techfit Digital Surgery, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k250520/ 2025-10-27 monthly 0.8 https://www.510kdatabase.net/og-image/k250520-osteocentric-navigated-instruments-fda-510k.jpg K250520 - OsteoCentric Navigated Instruments System K250520 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteocentric Technologies, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k251027/ 2025-10-27 monthly 0.8 https://www.510kdatabase.net/og-image/k251027-cvi42-coronary-plaque-software-fda-510k.jpg K251027 - cvi42 Coronary Plaque Software Application K251027 is a FDA 510(k) cleared radiology medical device. Manufacturer: Circle Cardiovascular Imaging, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k251331/ 2025-10-27 monthly 0.8 https://www.510kdatabase.net/og-image/k251331-blood-pressure-monitor-b73-be23t-fda-510k.jpg K251331 - Blood Pressure Monitor (B73, BE23T) K251331 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Jamr Technology Co., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k251824/ 2025-10-27 monthly 0.8 https://www.510kdatabase.net/og-image/k251824-patriot-duo-fda-510k.jpg K251824 - Patriot Duo K251824 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Patriot Laser, LLC. Cleared Oct 2025. https://www.510kdatabase.net/k251875/ 2025-10-27 monthly 0.8 https://www.510kdatabase.net/og-image/k251875-lifescale-gram-negative-kit-lsgn-with-fda-510k.jpg K251875 - LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system K251875 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Affinity Biosensors, LLC. Cleared Oct 2025. https://www.510kdatabase.net/k252053/ 2025-10-27 monthly 0.8 https://www.510kdatabase.net/og-image/k252053-vitamulti-functionheadbrush-tb-2443f-fda-510k.jpg K252053 - VITA Multi-Function Head Brush (TB-2443F, TB-2442AF, TB-2343F, TB-2442F) K252053 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k252467/ 2025-10-27 monthly 0.8 https://www.510kdatabase.net/og-image/k252467-disposable-vinyl-examination-gloves-fda-510k.jpg K252467 - Disposable Vinyl Examination Gloves K252467 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Viet Phu Trade and Import Export Co., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k252629/ 2025-10-27 monthly 0.8 https://www.510kdatabase.net/og-image/k252629-electric-breast-pump-hl-3058-f5112-fda-510k.jpg K252629 - Electric Breast Pump (HL-3058, F5112) K252629 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k252630/ 2025-10-27 monthly 0.8 https://www.510kdatabase.net/og-image/k252630-electric-breast-pump-hl-3060-f5113-fda-510k.jpg K252630 - Electric Breast Pump (HL-3060, F5113) K252630 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k250345/ 2025-10-24 monthly 0.8 https://www.510kdatabase.net/og-image/k250345-medline-bag-decanter-fda-510k.jpg K250345 - Medline Bag Decanter K250345 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, LP. Cleared Oct 2025. https://www.510kdatabase.net/k250687/ 2025-10-24 monthly 0.8 https://www.510kdatabase.net/og-image/k250687-cocoon-solo-dx-7020s-fda-510k.jpg K250687 - Cocoon Solo (DX-7020s) K250687 is a FDA 510(k) cleared radiology medical device. Manufacturer: Dexcowin Global, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k250696/ 2025-10-24 monthly 0.8 https://www.510kdatabase.net/og-image/k250696-accucheck-fda-510k.jpg K250696 - AccuCheck K250696 is a FDA 510(k) cleared radiology medical device. Manufacturer: Manteia Technologies Co., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k250904/ 2025-10-24 monthly 0.8 https://www.510kdatabase.net/og-image/k250904-atalante-x-fda-510k.jpg K250904 - Atalante X K250904 is a FDA 510(k) cleared neurology medical device. Manufacturer: Wandercraft SAS. Cleared Oct 2025. https://www.510kdatabase.net/k251059/ 2025-10-24 monthly 0.8 https://www.510kdatabase.net/og-image/k251059-syngo-carbon-clinicals-va41-fda-510k.jpg K251059 - Syngo Carbon Clinicals (VA41) K251059 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Healthineers AG. Cleared Oct 2025. https://www.510kdatabase.net/k251312/ 2025-10-24 monthly 0.8 https://www.510kdatabase.net/og-image/k251312-vesalio-peripheral-system-fda-510k.jpg K251312 - Vesalio Peripheral System K251312 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vesalio, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k251372/ 2025-10-24 monthly 0.8 https://www.510kdatabase.net/og-image/k251372-versad-delivery-catheter-fda-510k.jpg K251372 - VersaD Delivery Catheter K251372 is a FDA 510(k) cleared neurology medical device. Manufacturer: Unity Medical, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k251710/ 2025-10-24 monthly 0.8 https://www.510kdatabase.net/og-image/k251710-mobile-x-ray-unit-m1-fda-510k.jpg K251710 - Mobile X-ray unit (!M1) K251710 is a FDA 510(k) cleared radiology medical device. Manufacturer: Solutions For Tomorrow AB. Cleared Oct 2025. https://www.510kdatabase.net/k251784/ 2025-10-24 monthly 0.8 https://www.510kdatabase.net/og-image/k251784-hushd-pro-z-link-fda-510k.jpg K251784 - Hushd Pro Z-Link K251784 is a FDA 510(k) cleared dental medical device. Manufacturer: Good Sleep CO Pte , Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k251827/ 2025-10-24 monthly 0.8 https://www.510kdatabase.net/og-image/k251827-azurion-r31-fda-510k.jpg K251827 - Azurion R3.1 K251827 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems B.V.. Cleared Oct 2025. https://www.510kdatabase.net/k251974/ 2025-10-24 monthly 0.8 https://www.510kdatabase.net/og-image/k251974-arctic-sun-temperature-management-fda-510k.jpg K251974 - Arctic Sun Temperature Management System (Model 5000) K251974 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medivance, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k252044/ 2025-10-24 monthly 0.8 https://www.510kdatabase.net/og-image/k252044-triathlon-total-knee-system-triathlon-fda-510k.jpg K252044 - Triathlon® Total Knee System - Triathlon® Gold Femoral Components K252044 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp., Dba Stryker Orthopaedics. Cleared Oct 2025. https://www.510kdatabase.net/k252238/ 2025-10-24 monthly 0.8 https://www.510kdatabase.net/og-image/k252238-coroflow-cardiovascular-system-fda-510k.jpg K252238 - CoroFlow Cardiovascular System K252238 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Coroventis Research AB. Cleared Oct 2025. https://www.510kdatabase.net/k252357/ 2025-10-24 monthly 0.8 https://www.510kdatabase.net/og-image/k252357-glucose2-fda-510k.jpg K252357 - Glucose2 K252357 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Ireland. Cleared Oct 2025. https://www.510kdatabase.net/k252645/ 2025-10-24 monthly 0.8 https://www.510kdatabase.net/og-image/k252645-lumiguide-equipment-r21-fda-510k.jpg K252645 - LumiGuide Equipment R2.1 K252645 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Oct 2025. https://www.510kdatabase.net/k252646/ 2025-10-24 monthly 0.8 https://www.510kdatabase.net/og-image/k252646-single-use-fine-needle-biopsy-fnb-fda-510k.jpg K252646 - Single-Use Fine Needle Biopsy (FNB) device (NA-U210H) K252646 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Oct 2025. https://www.510kdatabase.net/k252730/ 2025-10-24 monthly 0.8 https://www.510kdatabase.net/og-image/k252730-fule-spinal-fixation-system-fda-510k.jpg K252730 - Fule Spinal Fixation System K252730 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Beijing Fule Science & Technology Development Co., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k253106/ 2025-10-24 monthly 0.8 https://www.510kdatabase.net/og-image/k253106-angiovac-cannula-fda-510k.jpg K253106 - AngioVac Cannula K253106 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: AngioDynamics, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k253125/ 2025-10-24 monthly 0.8 https://www.510kdatabase.net/og-image/k253125-parietene-flat-sheet-mesh-fda-510k.jpg K253125 - Parietene™ Flat Sheet Mesh K253125 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medtronic - Sofradim Production. Cleared Oct 2025. https://www.510kdatabase.net/k253129/ 2025-10-24 monthly 0.8 https://www.510kdatabase.net/og-image/k253129-infinity-oct-system-fda-510k.jpg K253129 - Infinity™ OCT System K253129 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k253150/ 2025-10-24 monthly 0.8 https://www.510kdatabase.net/og-image/k253150-cryon-x-cold-compression-fda-510k.jpg K253150 - Cryon-X Cold Compression K253150 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Jkh Health Co., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k253188/ 2025-10-24 monthly 0.8 https://www.510kdatabase.net/og-image/k253188-coaguchek-xs-plus-system-fda-510k.jpg K253188 - CoaguChek XS Plus System K253188 is a FDA 510(k) cleared hematology medical device. Manufacturer: Roche Diagnostics. Cleared Oct 2025. https://www.510kdatabase.net/k253335/ 2025-10-24 monthly 0.8 https://www.510kdatabase.net/og-image/k253335-cd-horizon-spinal-system-fda-510k.jpg K253335 - CD Horizon™ Spinal System K253335 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k253377/ 2025-10-24 monthly 0.8 https://www.510kdatabase.net/og-image/k253377-expandable-titanium-pliftlif-system-fda-510k.jpg K253377 - Expandable Titanium PLIF/TLIF System K253377 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spectrum Spine, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k250288/ 2025-10-23 monthly 0.8 https://www.510kdatabase.net/og-image/k250288-terarecon-cardiovascularcalcificationct-fda-510k.jpg K250288 - TeraRecon Cardiovascular.Calcification.CT K250288 is a FDA 510(k) cleared radiology medical device. Manufacturer: Terarecon,Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k250861/ 2025-10-23 monthly 0.8 https://www.510kdatabase.net/og-image/k250861-nitrile-powder-free-examination-glove-fda-510k.jpg K250861 - Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid (Black) K250861 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hartalega NGC Sdn. Bhd.. Cleared Oct 2025. https://www.510kdatabase.net/k252309/ 2025-10-23 monthly 0.8 https://www.510kdatabase.net/og-image/k252309-perqseal-introducers-fda-510k.jpg K252309 - PerQseal Introducers K252309 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vivasure Medical Limited. Cleared Oct 2025. https://www.510kdatabase.net/k252345/ 2025-10-23 monthly 0.8 https://www.510kdatabase.net/og-image/k252345-picosecond-laser-device-pf131-bi-fda-510k.jpg K252345 - Picosecond Laser Device (PF131-BI) K252345 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Risu Medical Technology Co., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k252384/ 2025-10-23 monthly 0.8 https://www.510kdatabase.net/og-image/k252384-dess-dental-smart-solutions-fda-510k.jpg K252384 - DESS® Dental Smart Solutions K252384 is a FDA 510(k) cleared dental medical device. Manufacturer: Terrats Medical SL. Cleared Oct 2025. https://www.510kdatabase.net/k252425/ 2025-10-23 monthly 0.8 https://www.510kdatabase.net/og-image/k252425-silatrix-oral-gel-fda-510k.jpg K252425 - Silatrix Oral Gel K252425 is a FDA 510(k) cleared dental medical device. Manufacturer: Sa3, LLC. Cleared Oct 2025. https://www.510kdatabase.net/k252732/ 2025-10-23 monthly 0.8 https://www.510kdatabase.net/og-image/k252732-1927nm-thulium-laser-system-pz-djg75-fda-510k.jpg K252732 - 1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02) K252732 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Zhengzhou PZ Laser Slim Technology Co., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k252931/ 2025-10-23 monthly 0.8 https://www.510kdatabase.net/og-image/k252931-invisalign-palatal-expander-system-fda-510k.jpg K252931 - Invisalign® Palatal Expander System K252931 is a FDA 510(k) cleared dental medical device. Manufacturer: Align Technology, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k253100/ 2025-10-23 monthly 0.8 https://www.510kdatabase.net/og-image/k253100-multipulse-tfl-fda-510k.jpg K253100 - MultiPulse TFL K253100 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Asclepion Laser Technologies GmbH. Cleared Oct 2025. https://www.510kdatabase.net/k253226/ 2025-10-23 monthly 0.8 https://www.510kdatabase.net/og-image/k253226-uv5000w-handle-fda-510k.jpg K253226 - UV5000W Handle K253226 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Uroviu Corporation. Cleared Oct 2025. https://www.510kdatabase.net/k250666/ 2025-10-22 monthly 0.8 https://www.510kdatabase.net/og-image/k250666-alegria-flash-ctd-screen-fda-510k.jpg K250666 - Alegria Flash CTD Screen K250666 is a FDA 510(k) cleared immunology medical device. Manufacturer: Zeus Scientific. Cleared Oct 2025. https://www.510kdatabase.net/k250955/ 2025-10-22 monthly 0.8 https://www.510kdatabase.net/og-image/k250955-xc11-ice-system-usa-fda-510k.jpg K250955 - XC11 ICE System, USA K250955 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Yorlabs, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k251030/ 2025-10-22 monthly 0.8 https://www.510kdatabase.net/og-image/k251030-sirona-advanced-imaging-suite-fda-510k.jpg K251030 - Sirona Advanced Imaging Suite K251030 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sirona Medical. Cleared Oct 2025. https://www.510kdatabase.net/k251185/ 2025-10-22 monthly 0.8 https://www.510kdatabase.net/og-image/k251185-recana-thrombectomy-catheter-system-fda-510k.jpg K251185 - Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020) K251185 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intervene. Cleared Oct 2025. https://www.510kdatabase.net/k251289/ 2025-10-22 monthly 0.8 https://www.510kdatabase.net/og-image/k251289-welllife-covid-19-antigen-test-rx-fda-510k.jpg K251289 - WELLlife COVID-19 Antigen Test Rx K251289 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k251628/ 2025-10-22 monthly 0.8 https://www.510kdatabase.net/og-image/k251628-mandibular-advancement-device-l07-fda-510k.jpg K251628 - Mandibular Advancement Device L07 K251628 is a FDA 510(k) cleared dental medical device. Manufacturer: Dcstar, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k251663/ 2025-10-22 monthly 0.8 https://www.510kdatabase.net/og-image/k251663-giraffe-omnibed-carestation-cs1-fda-510k.jpg K251663 - Giraffe OmniBed Carestation (CS1) K251663 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Datex-Ohmeda, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k251749/ 2025-10-22 monthly 0.8 https://www.510kdatabase.net/og-image/k251749-flowflex-plus-rsv-flu-ab-covid-home-test-fda-510k.jpg K251749 - Flowflex Plus RSV + Flu A/B + COVID Home Test K251749 is a FDA 510(k) cleared microbiology medical device. Manufacturer: ACON Laboratories, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k251977/ 2025-10-22 monthly 0.8 https://www.510kdatabase.net/og-image/k251977-electric-breast-pump-fz-p8-fda-510k.jpg K251977 - electric breast pump (FZ-P8) K251977 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ningbo Youhe Electrical Appliance Technology Co., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k252298/ 2025-10-22 monthly 0.8 https://www.510kdatabase.net/og-image/k252298-andi-20-fda-510k.jpg K252298 - ANDI 2.0 K252298 is a FDA 510(k) cleared radiology medical device. Manufacturer: Imeka Solutions, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k252322/ 2025-10-22 monthly 0.8 https://www.510kdatabase.net/og-image/k252322-siros-x-system-fda-510k.jpg K252322 - SIros-X System K252322 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Genesys Spine. Cleared Oct 2025. https://www.510kdatabase.net/k252325/ 2025-10-22 monthly 0.8 https://www.510kdatabase.net/og-image/k252325-hair-growth-laser-cap-fda-510k.jpg K252325 - Hair Growth Laser Cap K252325 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cosmo Far East Technology Limited. Cleared Oct 2025. https://www.510kdatabase.net/k252329/ 2025-10-22 monthly 0.8 https://www.510kdatabase.net/og-image/k252329-qiastat-dx-gastrointestinal-panel-2-fda-510k.jpg K252329 - QIAstat-Dx Gastrointestinal Panel 2 K252329 is a FDA 510(k) cleared microbiology medical device. Manufacturer: QIAGEN GmbH. Cleared Oct 2025. https://www.510kdatabase.net/k252569/ 2025-10-22 monthly 0.8 https://www.510kdatabase.net/og-image/k252569-carrier-xl-delivery-catheter-fda-510k.jpg K252569 - Carrier XL Delivery Catheter K252569 is a FDA 510(k) cleared neurology medical device. Manufacturer: Balt USA, LLC. Cleared Oct 2025. https://www.510kdatabase.net/k253144/ 2025-10-22 monthly 0.8 https://www.510kdatabase.net/og-image/k253144-freedom-total-knee-system-titan-pck-fda-510k.jpg K253144 - Freedom® Total Knee System – Titan PCK Components K253144 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Maxx Orthopedics, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k253145/ 2025-10-22 monthly 0.8 https://www.510kdatabase.net/og-image/k253145-pre-sutured-tendon-fda-510k.jpg K253145 - Pre-Sutured Tendon K253145 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Rti Surgical, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k253147/ 2025-10-22 monthly 0.8 https://www.510kdatabase.net/og-image/k253147-fibergraft-bg-putty-gps-bone-graft-fda-510k.jpg K253147 - FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft Substitute FIBERGRAFT™ AERIDYAN™ Matrix Bone Graft Substitute FIBERGRAFT™ BG Matrix Bone Graft Substitute K253147 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Prosidyan, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k231897/ 2025-10-21 monthly 0.8 https://www.510kdatabase.net/og-image/k231897-neuroalign-software-fda-510k.jpg K231897 - NeuroAlign software K231897 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medivis, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k250126/ 2025-10-21 monthly 0.8 https://www.510kdatabase.net/og-image/k250126-artiseal-vessel-sealing-system-fda-510k.jpg K250126 - ArtiSeal Vessel Sealing System - ArtiSeal Instruments (AS01M) K250126 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Livsmed, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k250394/ 2025-10-21 monthly 0.8 https://www.510kdatabase.net/og-image/k250394-fine-tto-fda-510k.jpg K250394 - Fine TTO™ K250394 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Bodycad Laboratories, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k250409/ 2025-10-21 monthly 0.8 https://www.510kdatabase.net/og-image/k250409-disposable-balloon-catheter-b5-2q-fda-510k.jpg K250409 - Disposable Balloon Catheter (B5-2Q) K250409 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Medical Systems Corporation. Cleared Oct 2025. https://www.510kdatabase.net/k250887/ 2025-10-21 monthly 0.8 https://www.510kdatabase.net/og-image/k250887-neuromuscular-transmission-monitor-fda-510k.jpg K250887 - Neuromuscular Transmission Monitor TOF3D (2510091) K250887 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: MIPM Mammendorfer Institut f?r Physik und Medizin GmbH. Cleared Oct 2025. https://www.510kdatabase.net/k251838/ 2025-10-21 monthly 0.8 https://www.510kdatabase.net/og-image/k251838-introducer-sheath-set-fda-510k.jpg K251838 - Introducer Sheath Set K251838 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cardiocycle Medical(Suzhou) Co., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k252346/ 2025-10-21 monthly 0.8 https://www.510kdatabase.net/og-image/k252346-olympic-posterior-spinal-fixation-system-fda-510k.jpg K252346 - OLYMPIC Posterior Spinal Fixation System K252346 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Astura Medical. Cleared Oct 2025. https://www.510kdatabase.net/k253033/ 2025-10-21 monthly 0.8 https://www.510kdatabase.net/og-image/k253033-chemfort-28-day-20-mm-vial-adaptor-and-fda-510k.jpg K253033 - Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor K253033 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Simplivia Healthcare , Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k253034/ 2025-10-21 monthly 0.8 https://www.510kdatabase.net/og-image/k253034-hemosphere-stream-module-fda-510k.jpg K253034 - HemoSphere Stream Module K253034 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences. Cleared Oct 2025. https://www.510kdatabase.net/k253040/ 2025-10-21 monthly 0.8 https://www.510kdatabase.net/og-image/k253040-aevumed-fase-suture-anchor-fda-510k.jpg K253040 - Aevumed FASE Suture Anchor K253040 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aevumed, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k253249/ 2025-10-21 monthly 0.8 https://www.510kdatabase.net/og-image/k253249-trialtis-spine-system-fda-510k.jpg K253249 - TriALTIS™ Spine System K253249 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International SARL. Cleared Oct 2025. https://www.510kdatabase.net/k242827/ 2025-10-20 monthly 0.8 https://www.510kdatabase.net/og-image/k242827-a8-integr8-porous-pedicle-screws-fda-510k.jpg K242827 - A8 INTEGR8™ Porous Pedicle Screws K242827 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Allumin8, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k251414/ 2025-10-20 monthly 0.8 https://www.510kdatabase.net/og-image/k251414-miracu-polydioxanone-pdo-suture-and-fda-510k.jpg K251414 - Miracu™ Polydioxanone (PDO) Suture and Needle (MONO) K251414 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Feeltech Co., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k252155/ 2025-10-20 monthly 0.8 https://www.510kdatabase.net/og-image/k252155-avava-skin-treatment-system-fda-510k.jpg K252155 - AVAVA™ Skin Treatment System K252155 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Avava, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k252277/ 2025-10-20 monthly 0.8 https://www.510kdatabase.net/og-image/k252277-spiral-laminar-flow-vascular-fda-510k.jpg K252277 - Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645) K252277 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vascular Flow Technologies Limited. Cleared Oct 2025. https://www.510kdatabase.net/k252319/ 2025-10-20 monthly 0.8 https://www.510kdatabase.net/og-image/k252319-q-switched-nd-yag-laser-machine-lfs-c13u-fda-510k.jpg K252319 - Q-Switched Nd: YAG Laser machine (LFS-C13U) K252319 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sanhe?Lefis?Electronics?Co., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k252640/ 2025-10-20 monthly 0.8 https://www.510kdatabase.net/og-image/k252640-veresee-optical-veres-needle-and-fda-510k.jpg K252640 - VereSee Optical Veres Needle and Endoscopic Camera K252640 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Freyja Healthcare, LLC. Cleared Oct 2025. https://www.510kdatabase.net/k252665/ 2025-10-20 monthly 0.8 https://www.510kdatabase.net/og-image/k252665-brain-shoulder-positioning-fda-510k.jpg K252665 - brAIn™ Shoulder Positioning K252665 is a FDA 510(k) cleared radiology medical device. Manufacturer: Avatar Medical. Cleared Oct 2025. https://www.510kdatabase.net/k253182/ 2025-10-20 monthly 0.8 https://www.510kdatabase.net/og-image/k253182-inkspace-imaging-small-body-array-fda-510k.jpg K253182 - InkSpace Imaging Small Body Array (SBA12PH30x) K253182 is a FDA 510(k) cleared radiology medical device. Manufacturer: Inkspace Imaging, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k250145/ 2025-10-17 monthly 0.8 https://www.510kdatabase.net/og-image/k250145-biopsy-port-adapter-fda-510k.jpg K250145 - Biopsy Port Adapter K250145 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Endosound, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k250159/ 2025-10-17 monthly 0.8 https://www.510kdatabase.net/og-image/k250159-immunoglobulin-isotypes-gam-for-the-fda-510k.jpg K250159 - Immunoglobulin Isotypes (GAM) for the EXENT Analyser K250159 is a FDA 510(k) cleared immunology medical device. Manufacturer: The Binding Site Group , Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k250178/ 2025-10-17 monthly 0.8 https://www.510kdatabase.net/og-image/k250178-adin-customized-abutments-fda-510k.jpg K250178 - Adin Customized Abutments K250178 is a FDA 510(k) cleared dental medical device. Manufacturer: Adin Dental Implant Systems , Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k250197/ 2025-10-17 monthly 0.8 https://www.510kdatabase.net/og-image/k250197-estremo-fibular-nail-fda-510k.jpg K250197 - Estremo Fibular Nail K250197 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Citieffe S.R.L.. Cleared Oct 2025. https://www.510kdatabase.net/k250203/ 2025-10-17 monthly 0.8 https://www.510kdatabase.net/og-image/k250203-sureax-guide-fda-510k.jpg K250203 - SureAx-Guide™ K250203 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sureax Medical, LLC. Cleared Oct 2025. https://www.510kdatabase.net/k250227/ 2025-10-17 monthly 0.8 https://www.510kdatabase.net/og-image/k250227-jovs-electric-stimulation-beauty-fda-510k.jpg K250227 - JOVS Electric Stimulation Beauty Device (JE2) K250227 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Qianyu Technology Co., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k250250/ 2025-10-17 monthly 0.8 https://www.510kdatabase.net/og-image/k250250-advia-centaur-anti-thyroid-peroxidase-ii-fda-510k.jpg K250250 - ADVIA Centaur Anti-Thyroid Peroxidase II K250250 is a FDA 510(k) cleared immunology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k250911/ 2025-10-17 monthly 0.8 https://www.510kdatabase.net/og-image/k250911-moskin-radiation-measurement-system-fda-510k.jpg K250911 - MOSkin Radiation Measurement System K250911 is a FDA 510(k) cleared radiology medical device. Manufacturer: Electrogenics Labs, Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k250945/ 2025-10-17 monthly 0.8 https://www.510kdatabase.net/og-image/k250945-single-use-preloaded-sphincterotome-v-fda-510k.jpg K250945 - Single Use Preloaded Sphincterotome V (Distal Wire Guided) (KD-VC600 Series) K250945 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Oct 2025. https://www.510kdatabase.net/k251146/ 2025-10-17 monthly 0.8 https://www.510kdatabase.net/og-image/k251146-intellivue-patient-monitors-mx400-fda-510k.jpg K251146 - IntelliVue Patient monitors MX400, MX450, MX500, MX550 K251146 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Philips Medizin Systeme Boeblingen GmbH. Cleared Oct 2025. https://www.510kdatabase.net/k251282/ 2025-10-17 monthly 0.8 https://www.510kdatabase.net/og-image/k251282-stealthstation-s8-spine-software-fda-510k.jpg K251282 - StealthStation S8 Spine Software K251282 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Navigation, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k251355/ 2025-10-17 monthly 0.8 https://www.510kdatabase.net/og-image/k251355-x1-ffr-fda-510k.jpg K251355 - X1-FFR K251355 is a FDA 510(k) cleared radiology medical device. Manufacturer: Spectrawave, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k251673/ 2025-10-17 monthly 0.8 https://www.510kdatabase.net/og-image/k251673-x9-ultrasound-system-fda-510k.jpg K251673 - X9 Ultrasound System K251673 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: X9, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k251778/ 2025-10-17 monthly 0.8 https://www.510kdatabase.net/og-image/k251778-remi-custom-night-guard-fda-510k.jpg K251778 - Remi Custom Night Guard K251778 is a FDA 510(k) cleared dental medical device. Manufacturer: Remi. Cleared Oct 2025. https://www.510kdatabase.net/k251832/ 2025-10-17 monthly 0.8 https://www.510kdatabase.net/og-image/k251832-inzone-ist-detachment-system-fda-510k.jpg K251832 - InZone IST Detachment System K251832 is a FDA 510(k) cleared neurology medical device. Manufacturer: Stryker Neurovascular. Cleared Oct 2025. https://www.510kdatabase.net/k252075/ 2025-10-17 monthly 0.8 https://www.510kdatabase.net/og-image/k252075-program-insite-powder-free-disposable-fda-510k.jpg K252075 - Program insite® Powder-Free, Disposable Nitrile Exam Gloves K252075 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Program Insite, LLC. Cleared Oct 2025. https://www.510kdatabase.net/k252254/ 2025-10-17 monthly 0.8 https://www.510kdatabase.net/og-image/k252254-osteotomy-wedge-system-fda-510k.jpg K252254 - Osteotomy Wedge System K252254 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Sinaptic Surgical. Cleared Oct 2025. https://www.510kdatabase.net/k252264/ 2025-10-17 monthly 0.8 https://www.510kdatabase.net/og-image/k252264-megelin-led-light-therapy-mask-jml1-fda-510k.jpg K252264 - MEGELIN LED Light Therapy Mask (JML1, JML1+JML2) K252264 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Zhenxing Ruitong Technology Co., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k252266/ 2025-10-17 monthly 0.8 https://www.510kdatabase.net/og-image/k252266-sin-dental-implant-system-fda-510k.jpg K252266 - S.I.N. Dental Implant System K252266 is a FDA 510(k) cleared dental medical device. Manufacturer: S.I.N. Implant System Ltda. Cleared Oct 2025. https://www.510kdatabase.net/den240076/ 2025-10-17 monthly 0.8 https://www.510kdatabase.net/og-image/den240076-modius-lean-fda-510k.jpg DEN240076 - Modius Lean DEN240076 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Neurovalens Limited. Cleared Oct 2025. https://www.510kdatabase.net/k242100/ 2025-10-16 monthly 0.8 https://www.510kdatabase.net/og-image/k242100-surgiaid-collagen-wound-dressing-ha-fda-510k.jpg K242100 - SurgiAid Collagen Wound Dressing (HA) K242100 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Maxigen Biotech, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k243727/ 2025-10-16 monthly 0.8 https://www.510kdatabase.net/og-image/k243727-rebalans-fda-510k.jpg K243727 - Re:Balans K243727 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Mode Sensors AS. Cleared Oct 2025. https://www.510kdatabase.net/k250731/ 2025-10-16 monthly 0.8 https://www.510kdatabase.net/og-image/k250731-matelaser-medical-diode-laser-systems-fda-510k.jpg K250731 - MateLaser Medical Diode Laser Systems (ML-DLS-30) K250731 is a FDA 510(k) cleared dental medical device. Manufacturer: Matelaser, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k250852/ 2025-10-16 monthly 0.8 https://www.510kdatabase.net/og-image/k250852-coolfase-fda-510k.jpg K250852 - Coolfase K250852 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Asterasys Co., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k251497/ 2025-10-16 monthly 0.8 https://www.510kdatabase.net/og-image/k251497-elos-accurate-hybrid-base-fda-510k.jpg K251497 - Elos Accurate Hybrid Base K251497 is a FDA 510(k) cleared dental medical device. Manufacturer: Elos Medtech Pinol A/S. Cleared Oct 2025. https://www.510kdatabase.net/k251882/ 2025-10-16 monthly 0.8 https://www.510kdatabase.net/og-image/k251882-uterine-aspiration-set-fda-510k.jpg K251882 - Uterine Aspiration Set K251882 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Gcmedica Enterprise Ltd.(Wuxi). Cleared Oct 2025. https://www.510kdatabase.net/k251994/ 2025-10-16 monthly 0.8 https://www.510kdatabase.net/og-image/k251994-arthrex-synergy-vision-imaging-system-fda-510k.jpg K251994 - Arthrex Synergy Vision Imaging System K251994 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Arthrex, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k252024/ 2025-10-16 monthly 0.8 https://www.510kdatabase.net/og-image/k252024-neuraxis-ib-stim-01-1020-fda-510k.jpg K252024 - NeurAxis IB-Stim (01-1020) K252024 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Neuraxis. Cleared Oct 2025. https://www.510kdatabase.net/k252093/ 2025-10-16 monthly 0.8 https://www.510kdatabase.net/og-image/k252093-light-therapy-mask-1019055-fda-510k.jpg K252093 - Light Therapy Mask (1019055) K252093 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Merchsource, LLC. Cleared Oct 2025. https://www.510kdatabase.net/k252153/ 2025-10-16 monthly 0.8 https://www.510kdatabase.net/og-image/k252153-ffx-facet-fixation-system-fda-510k.jpg K252153 - FFX Facet Fixation System K252153 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Sc Medica. Cleared Oct 2025. https://www.510kdatabase.net/k252223/ 2025-10-16 monthly 0.8 https://www.510kdatabase.net/og-image/k252223-alpha-endo-handpiece-alpha-endo-fda-510k.jpg K252223 - Alpha Endo Handpiece (Alpha Endo) K252223 is a FDA 510(k) cleared dental medical device. Manufacturer: SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.. Cleared Oct 2025. https://www.510kdatabase.net/k252247/ 2025-10-16 monthly 0.8 https://www.510kdatabase.net/og-image/k252247-injector-force-max-single-use-injector-fda-510k.jpg K252247 - Injector Force Max Single Use Injector (NM-400L) K252247 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Medical Systems Corporation. Cleared Oct 2025. https://www.510kdatabase.net/k252476/ 2025-10-16 monthly 0.8 https://www.510kdatabase.net/og-image/k252476-viewer-54-fda-510k.jpg K252476 - Viewer (5.4) K252476 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab AG. Cleared Oct 2025. https://www.510kdatabase.net/k252612/ 2025-10-16 monthly 0.8 https://www.510kdatabase.net/og-image/k252612-indigo-aspiration-system-lightning-fda-510k.jpg K252612 - INDIGO® Aspiration System – Lightning Flash Aspiration Tubing K252612 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Penumbra, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k252631/ 2025-10-16 monthly 0.8 https://www.510kdatabase.net/og-image/k252631-profoject-disposable-needle-fda-510k.jpg K252631 - Profoject™ Disposable Needle K252631 is a FDA 510(k) cleared general hospital medical device. Manufacturer: CMT Health PTE., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k253000/ 2025-10-16 monthly 0.8 https://www.510kdatabase.net/og-image/k253000-cryofreeze-wart-and-skin-tag-remover-fda-510k.jpg K253000 - CryoFreeze Wart and Skin Tag Remover K253000 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cryosurgery, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k253024/ 2025-10-16 monthly 0.8 https://www.510kdatabase.net/og-image/k253024-prozip-knotless-implant-fda-510k.jpg K253024 - ProZip Knotless Implant K253024 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Riverpoint Medical. Cleared Oct 2025. https://www.510kdatabase.net/k253114/ 2025-10-16 monthly 0.8 https://www.510kdatabase.net/og-image/k253114-targetcool-rm-dt02w-fda-510k.jpg K253114 - TargetCool™ (RM-DT02W) K253114 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Recensmedical, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k250107/ 2025-10-15 monthly 0.8 https://www.510kdatabase.net/og-image/k250107-v-soft-line-barbed-surgical-suture-fda-510k.jpg K250107 - V-soft Line™ Barbed Surgical Suture (Various) K250107 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Feeltech Co., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k250510/ 2025-10-15 monthly 0.8 https://www.510kdatabase.net/og-image/k250510-sure-fine-insulin-syringes-fda-510k.jpg K250510 - Sure-Fine Insulin Syringes K250510 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shina Med Corporation. Cleared Oct 2025. https://www.510kdatabase.net/k250979/ 2025-10-15 monthly 0.8 https://www.510kdatabase.net/og-image/k250979-thermogard-hq-temperature-management-fda-510k.jpg K250979 - Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp™ Universal Pad) K250979 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Zoll Circulation, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k251294/ 2025-10-15 monthly 0.8 https://www.510kdatabase.net/og-image/k251294-bonafix-implant-abutments-fda-510k.jpg K251294 - Bonafix Implant Abutments K251294 is a FDA 510(k) cleared dental medical device. Manufacturer: Zentek Medical, LLC. Cleared Oct 2025. https://www.510kdatabase.net/k251805/ 2025-10-15 monthly 0.8 https://www.510kdatabase.net/og-image/k251805-syngoct-dual-energy-fda-510k.jpg K251805 - syngo.CT Dual Energy K251805 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k252020/ 2025-10-15 monthly 0.8 https://www.510kdatabase.net/og-image/k252020-tunnelvision-endoscopic-soft-tissue-fda-510k.jpg K252020 - TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly K252020 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Hand Biomechanics Lab, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k252199/ 2025-10-15 monthly 0.8 https://www.510kdatabase.net/og-image/k252199-agfa-healthcare-enterprise-imaging-fda-510k.jpg K252199 - AGFA HealthCare Enterprise Imaging K252199 is a FDA 510(k) cleared radiology medical device. Manufacturer: Agfa Healthcare N.V.. Cleared Oct 2025. https://www.510kdatabase.net/k252367/ 2025-10-15 monthly 0.8 https://www.510kdatabase.net/og-image/k252367-inbellamulti-system-fda-510k.jpg K252367 - InbellaMulti System K252367 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Inbella Medical, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k252920/ 2025-10-15 monthly 0.8 https://www.510kdatabase.net/og-image/k252920-eleos-limb-salvage-system-with-fda-510k.jpg K252920 - ELEOS™ Limb Salvage System with NanoCept® Technology K252920 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Onkos Surgical, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k252944/ 2025-10-15 monthly 0.8 https://www.510kdatabase.net/og-image/k252944-locator-angled-abutment-fda-510k.jpg K252944 - LOCATOR® Angled Abutment K252944 is a FDA 510(k) cleared dental medical device. Manufacturer: Zest Anchors, LLC. Cleared Oct 2025. https://www.510kdatabase.net/k252946/ 2025-10-15 monthly 0.8 https://www.510kdatabase.net/og-image/k252946-biobrace-extra-articular-ligament-fda-510k.jpg K252946 - BioBrace® Extra-Articular Ligament Augmentation Kit K252946 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Conmed Corporation. Cleared Oct 2025. https://www.510kdatabase.net/k253348/ 2025-10-15 monthly 0.8 https://www.510kdatabase.net/og-image/k253348-targetcool-e-fda-510k.jpg K253348 - TargetCool-e K253348 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Recensmedical, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k250115/ 2025-10-14 monthly 0.8 https://www.510kdatabase.net/og-image/k250115-hemastyl-wound-dressing-fda-510k.jpg K250115 - Hemastyl(™) Wound Dressing K250115 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Rapid Nexus Nanotech Wound Solutions, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k250776/ 2025-10-14 monthly 0.8 https://www.510kdatabase.net/og-image/k250776-lithoblast-single-use-holmium-laser-fda-510k.jpg K250776 - Lithoblast Single Use Holmium Laser Fibers K250776 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Dawell Medical, LLC. Cleared Oct 2025. https://www.510kdatabase.net/k251715/ 2025-10-14 monthly 0.8 https://www.510kdatabase.net/og-image/k251715-flowart-vial-access-device-vented-fda-510k.jpg K251715 - FlowArt® Vial Access Device Vented K251715 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Asset Medikal. Cleared Oct 2025. https://www.510kdatabase.net/k251874/ 2025-10-14 monthly 0.8 https://www.510kdatabase.net/og-image/k251874-pureway-sharps-container-1-gal-2-gal-3-fda-510k.jpg K251874 - PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013) K251874 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Pureway Compliance, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k252234/ 2025-10-14 monthly 0.8 https://www.510kdatabase.net/og-image/k252234-ipl-home-use-hair-removal-device-fda-510k.jpg K252234 - IPL Home Use Hair Removal Device (Models: FDA11, FDA12, FDA13, FDA14, FDA15, FDA16, FDA17, FDA18, FDA19, FDA20, FDA21S, FDA22S, FDA23S, FDA24S, FDA25, FDA26, FDA27, FDA28, FDA29S, FDA30S, FDA31S) K252234 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Qiaochengli Technology Co., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k252637/ 2025-10-14 monthly 0.8 https://www.510kdatabase.net/og-image/k252637-community-containers-flap-and-daisy-fda-510k.jpg K252637 - Community Containers (Flap and Daisy) K252637 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Keter Canada, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k253010/ 2025-10-14 monthly 0.8 https://www.510kdatabase.net/og-image/k253010-mini-superhawk-suture-anchor-system-fda-510k.jpg K253010 - Mini Superhawk Suture Anchor System K253010 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Responsive Arthroscopy, LLC. Cleared Oct 2025. https://www.510kdatabase.net/k253099/ 2025-10-14 monthly 0.8 https://www.510kdatabase.net/og-image/k253099-lifepak-15-ac-power-adapter-41577-000333-fda-510k.jpg K253099 - LIFEPAK 15 AC Power Adapter (41577-000333) K253099 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Physio-Control, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k253331/ 2025-10-14 monthly 0.8 https://www.510kdatabase.net/og-image/k253331-presson-spinal-fixation-system-fda-510k.jpg K253331 - PressON Spinal Fixation System K253331 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nexus Spine. Cleared Oct 2025. https://www.510kdatabase.net/k253461/ 2025-10-14 monthly 0.8 https://www.510kdatabase.net/og-image/k253461-demi-pro-fda-510k.jpg K253461 - Demi Pro K253461 is a FDA 510(k) cleared dental medical device. Manufacturer: Meta Systems Co., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k251522/ 2025-10-13 monthly 0.8 https://www.510kdatabase.net/og-image/k251522-mg-osteoinject-fda-510k.jpg K251522 - Mg OSTEOINJECT™ K251522 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Bone Solutions, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k242227/ 2025-10-12 monthly 0.8 https://www.510kdatabase.net/og-image/k242227-geneo-x-elite-fda-510k.jpg K242227 - GENEO X ELITE K242227 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Pollogen, Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k251034/ 2025-10-12 monthly 0.8 https://www.510kdatabase.net/og-image/k251034-radiant-renewal-skincare-lid-hd-59a-hd-fda-510k.jpg K251034 - Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70) K251034 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Nuon Medical Equipment Co., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k251595/ 2025-10-12 monthly 0.8 https://www.510kdatabase.net/og-image/k251595-covid-19-detect-rapid-self-test-fda-510k.jpg K251595 - COVID-19 Detect Rapid Self -Test K251595 is a FDA 510(k) cleared microbiology medical device. Manufacturer: InBios International, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k243078/ 2025-10-10 monthly 0.8 https://www.510kdatabase.net/og-image/k243078-hexaplus-s-onedrill-implant-system-fda-510k.jpg K243078 - HexaPLUS S OneDrill Implant System K243078 is a FDA 510(k) cleared dental medical device. Manufacturer: Osseofuse International, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k243815/ 2025-10-10 monthly 0.8 https://www.510kdatabase.net/og-image/k243815-soclean-3-fda-510k.jpg K243815 - SoClean 3+ K243815 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Soclean, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k250085/ 2025-10-10 monthly 0.8 https://www.510kdatabase.net/og-image/k250085-on-call-sure-gk-blood-glucose-ketone-fda-510k.jpg K250085 - On Call® Sure GK Blood Glucose & Ketone Monitoring System K250085 is a FDA 510(k) cleared chemistry medical device. Manufacturer: ACON Laboratories, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k250249/ 2025-10-10 monthly 0.8 https://www.510kdatabase.net/og-image/k250249-gold-standard-diagnostics-gsd-aix1000-fda-510k.jpg K250249 - Gold Standard Diagnostics (GSD) AIX1000 Rapid Plasma Reagin (RPR) Automated Test System K250249 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Gold Standard Diagnostics, LLC. Cleared Oct 2025. https://www.510kdatabase.net/k250351/ 2025-10-10 monthly 0.8 https://www.510kdatabase.net/og-image/k250351-single-use-electrosurgical-knife-kd-fda-510k.jpg K250351 - Single Use Electrosurgical Knife (KD-612L, KD-612U) K250351 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Medical Systems Corporation. Cleared Oct 2025. https://www.510kdatabase.net/k251082/ 2025-10-10 monthly 0.8 https://www.510kdatabase.net/og-image/k251082-hydros-robotic-system-hy1000-fda-510k.jpg K251082 - HYDROS Robotic System (HY1000) K251082 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Procept Biorobotics. Cleared Oct 2025. https://www.510kdatabase.net/k251602/ 2025-10-10 monthly 0.8 https://www.510kdatabase.net/og-image/k251602-alphenix-infx-8000vb-infx-8000vs-v96-fda-510k.jpg K251602 - Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging K251602 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Oct 2025. https://www.510kdatabase.net/k251708/ 2025-10-10 monthly 0.8 https://www.510kdatabase.net/og-image/k251708-evoendo-single-use-endoscopy-system-fda-510k.jpg K251708 - EvoEndo Single-Use Endoscopy System K251708 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: EvoEndo, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k251835/ 2025-10-10 monthly 0.8 https://www.510kdatabase.net/og-image/k251835-yomi-robotic-system-fda-510k.jpg K251835 - Yomi Robotic System K251835 is a FDA 510(k) cleared dental medical device. Manufacturer: Neocis, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k251866/ 2025-10-10 monthly 0.8 https://www.510kdatabase.net/og-image/k251866-tegaderm-post-op-transparent-fda-510k.jpg K251866 - Tegaderm Post-Op Transparent Antimicrobial Dressing K251866 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Solventum US, LLC. Cleared Oct 2025. https://www.510kdatabase.net/k251927/ 2025-10-10 monthly 0.8 https://www.510kdatabase.net/og-image/k251927-zeta-navigation-system-zns131-us-fda-510k.jpg K251927 - Zeta Navigation System (ZNS131-US) K251927 is a FDA 510(k) cleared neurology medical device. Manufacturer: Zeta Surgical, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k252001/ 2025-10-10 monthly 0.8 https://www.510kdatabase.net/og-image/k252001-collagen-wound-dressing-fda-510k.jpg K252001 - Collagen Wound Dressing K252001 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Winner Medical Co., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k252209/ 2025-10-10 monthly 0.8 https://www.510kdatabase.net/og-image/k252209-ipl-home-use-hair-removal-device-jd-fda-510k.jpg K252209 - IPL Home Use Hair Removal Device (JD-TM016, JD-TM023, JD-TM027, JD-TM028, JD-TM032) K252209 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Foshan Jindi Electric Appliance Co., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k252312/ 2025-10-10 monthly 0.8 https://www.510kdatabase.net/og-image/k252312-eleganz-im-threaded-nail-system-im-fda-510k.jpg K252312 - Eleganz IM Threaded Nail System (IM Threaded Nail System) K252312 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Dev4. Cleared Oct 2025. https://www.510kdatabase.net/k252544/ 2025-10-10 monthly 0.8 https://www.510kdatabase.net/og-image/k252544-tmini-miniature-robotic-system-fda-510k.jpg K252544 - TMINI Miniature Robotic System K252544 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: THINK Surgical, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k252737/ 2025-10-10 monthly 0.8 https://www.510kdatabase.net/og-image/k252737-degen-medical-latitude-c-am-cervical-fda-510k.jpg K252737 - DeGen Medical Latitude-C AM Cervical Interbody Fusion System K252737 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Degen Medical. Cleared Oct 2025. https://www.510kdatabase.net/k252903/ 2025-10-10 monthly 0.8 https://www.510kdatabase.net/og-image/k252903-verruca-freeze-h-plus-fda-510k.jpg K252903 - Verruca-Freeze H Plus K252903 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cryosurgery, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k250645/ 2025-10-09 monthly 0.8 https://www.510kdatabase.net/og-image/k250645-sleevelux-24-anoscopeproctoscope-p2001-fda-510k.jpg K250645 - SleeveLUX 24 Anoscope/Proctoscope (P2001) K250645 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Haemoband Surgical, Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k251366/ 2025-10-09 monthly 0.8 https://www.510kdatabase.net/og-image/k251366-eeg-1260a-neurofax-system-eeg-1260a-fda-510k.jpg K251366 - EEG-1260A Neurofax System (EEG-1260A) K251366 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nihon Kohden Corporation. Cleared Oct 2025. https://www.510kdatabase.net/k251651/ 2025-10-09 monthly 0.8 https://www.510kdatabase.net/og-image/k251651-epiq-series-diagnostic-ultrasound-system-fda-510k.jpg K251651 - EPIQ Series Diagnostic Ultrasound System K251651 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Ultrasound, LLC. Cleared Oct 2025. https://www.510kdatabase.net/k251795/ 2025-10-09 monthly 0.8 https://www.510kdatabase.net/og-image/k251795-wrist-automatic-blood-pressure-monitor-fda-510k.jpg K251795 - Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753) K251795 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Honsun (Nantong) Co., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k251851/ 2025-10-09 monthly 0.8 https://www.510kdatabase.net/og-image/k251851-diasafeplusus-f00013010-fda-510k.jpg K251851 - DIASAFEplusUS (F00013010) K251851 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC. Cleared Oct 2025. https://www.510kdatabase.net/k251876/ 2025-10-09 monthly 0.8 https://www.510kdatabase.net/og-image/k251876-cleadew-gp-hydra-one-fda-510k.jpg K251876 - cleadew GP hydra one K251876 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Ophtecs Corporation. Cleared Oct 2025. https://www.510kdatabase.net/k252272/ 2025-10-09 monthly 0.8 https://www.510kdatabase.net/og-image/k252272-ora-method-led-gua-sha-gs-04-fda-510k.jpg K252272 - ORA Method LED Gua Sha (GS-04) K252272 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Kaiyan Medical Equipment Co., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k252553/ 2025-10-09 monthly 0.8 https://www.510kdatabase.net/og-image/k252553-facial-body-beauty-device-inia-bd001-fda-510k.jpg K252553 - Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507) K252553 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Jianchao Intelligent Technology Co., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k252600/ 2025-10-09 monthly 0.8 https://www.510kdatabase.net/og-image/k252600-pediatric-plating-platform-i-small-mini-fda-510k.jpg K252600 - Pediatric Plating Platform I Small-Mini K252600 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OrthoPediatrics Corp.. Cleared Oct 2025. https://www.510kdatabase.net/k252867/ 2025-10-09 monthly 0.8 https://www.510kdatabase.net/og-image/k252867-vinscreen-urine-drug-test-cup-fda-510k.jpg K252867 - VINScreen Urine Drug Test Cup K252867 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Advin Biotech, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k252870/ 2025-10-09 monthly 0.8 https://www.510kdatabase.net/og-image/k252870-invisalign-specifix-attachment-system-fda-510k.jpg K252870 - Invisalign Specifix Attachment System K252870 is a FDA 510(k) cleared dental medical device. Manufacturer: Align Technology, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k252910/ 2025-10-09 monthly 0.8 https://www.510kdatabase.net/og-image/k252910-orca-airwater-and-suction-valves-fda-510k.jpg K252910 - Orca Air/Water and Suction Valves K252910 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific. Cleared Oct 2025. https://www.510kdatabase.net/k252911/ 2025-10-09 monthly 0.8 https://www.510kdatabase.net/og-image/k252911-lux-hd-2530-detector-lux-hd-2530-fda-510k.jpg K252911 - Lux HD 2530 detector (Lux HD 2530) K252911 is a FDA 510(k) cleared radiology medical device. Manufacturer: Iray Imaging Technology (Haining) Limited. Cleared Oct 2025. https://www.510kdatabase.net/k252939/ 2025-10-09 monthly 0.8 https://www.510kdatabase.net/og-image/k252939-cohitech-organic-cotton-compact-fda-510k.jpg K252939 - COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONS K252939 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Cotton High Tech S.L.. Cleared Oct 2025. https://www.510kdatabase.net/k253094/ 2025-10-09 monthly 0.8 https://www.510kdatabase.net/og-image/k253094-ifuse-bedrock-granite-implant-system-fda-510k.jpg K253094 - iFuse Bedrock Granite Implant System K253094 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SI-BONE, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k250060/ 2025-10-08 monthly 0.8 https://www.510kdatabase.net/og-image/k250060-gt300-fda-510k.jpg K250060 - GT300 K250060 is a FDA 510(k) cleared radiology medical device. Manufacturer: Genoray Co., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k250298/ 2025-10-08 monthly 0.8 https://www.510kdatabase.net/og-image/k250298-kiwi-complete-vacuum-delivery-system-fda-510k.jpg K250298 - Kiwi® Complete Vacuum Delivery System, OmniCup® (VAC-DUAL M) K250298 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Clinical Innovations, LLC. Cleared Oct 2025. https://www.510kdatabase.net/k250536/ 2025-10-08 monthly 0.8 https://www.510kdatabase.net/og-image/k250536-metafore-small-screw-system-fda-510k.jpg K250536 - MetaFore Small Screw System K250536 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Extremity Medical, LLC. Cleared Oct 2025. https://www.510kdatabase.net/k251162/ 2025-10-08 monthly 0.8 https://www.510kdatabase.net/og-image/k251162-cusa-clarity-ultrasonic-surgical-fda-510k.jpg K251162 - CUSA® Clarity Ultrasonic Surgical Aspirator System K251162 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Integra LifeSciences Corporation. Cleared Oct 2025. https://www.510kdatabase.net/k251363/ 2025-10-08 monthly 0.8 https://www.510kdatabase.net/og-image/k251363-proknow-ds-fda-510k.jpg K251363 - ProKnow DS K251363 is a FDA 510(k) cleared radiology medical device. Manufacturer: Elekta Solutions AB. Cleared Oct 2025. https://www.510kdatabase.net/k251422/ 2025-10-08 monthly 0.8 https://www.510kdatabase.net/og-image/k251422-bd-saf-t-intima-subcutaneous-catheter-fda-510k.jpg K251422 - BD Saf-T-Intima™ Subcutaneous Catheter System K251422 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton Dickinson Infusion Therapy Systems, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k251699/ 2025-10-08 monthly 0.8 https://www.510kdatabase.net/og-image/k251699-the-botticelli-model-athena-fda-510k.jpg K251699 - The Botticelli (Model: Athena) K251699 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bellamia Technologies, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k252163/ 2025-10-08 monthly 0.8 https://www.510kdatabase.net/og-image/k252163-elecsys-phospho-tau-181p-plasma-fda-510k.jpg K252163 - Elecsys Phospho-Tau (181P) Plasma K252163 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics. Cleared Oct 2025. https://www.510kdatabase.net/k252766/ 2025-10-08 monthly 0.8 https://www.510kdatabase.net/og-image/k252766-14fr-low-profile-introducer-kit-fda-510k.jpg K252766 - 14Fr Low Profile Introducer Kit K252766 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abiomed, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k252874/ 2025-10-08 monthly 0.8 https://www.510kdatabase.net/og-image/k252874-compass-steerable-needle-with-adapters-fda-510k.jpg K252874 - Compass Steerable Needle with Adapters SRA-1-01 and SRA-2-01 K252874 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Serpex Medical, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k244041/ 2025-10-07 monthly 0.8 https://www.510kdatabase.net/og-image/k244041-ultrasound-therapy-workstation-xms-uet2-fda-510k.jpg K244041 - Ultrasound Therapy Workstation (XMS-UET2) K244041 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Xemis Medical Technology (Shenzhen) Co., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k250187/ 2025-10-07 monthly 0.8 https://www.510kdatabase.net/og-image/k250187-disposable-hot-biopsy-forceps-fd-210u-fda-510k.jpg K250187 - Disposable Hot Biopsy Forceps (FD-210U) K250187 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Medical Systems Corporation. Cleared Oct 2025. https://www.510kdatabase.net/k250364/ 2025-10-07 monthly 0.8 https://www.510kdatabase.net/og-image/k250364-saview-sh-optic-38-uv-senofilcon-a-fda-510k.jpg K250364 - Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens K250364 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: St. shine Optical Co., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k250688/ 2025-10-07 monthly 0.8 https://www.510kdatabase.net/og-image/k250688-cedar-endovenous-radiofrequency-fda-510k.jpg K250688 - Cedar™ Endovenous Radiofrequency Catheter (ERA-C70-US) K250688 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Acotec Scientific Co., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k250894/ 2025-10-07 monthly 0.8 https://www.510kdatabase.net/og-image/k250894-eminent-spine-posterior-si-system-fda-510k.jpg K250894 - Eminent Spine Posterior SI System K250894 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Eminent Spine. Cleared Oct 2025. https://www.510kdatabase.net/k252150/ 2025-10-07 monthly 0.8 https://www.510kdatabase.net/og-image/k252150-ultrasonic-bipolar-generator-usg-410-fda-510k.jpg K252150 - Ultrasonic Bipolar Generator (USG-410) K252150 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Olympus Medical Systems Corporation. Cleared Oct 2025. https://www.510kdatabase.net/k252214/ 2025-10-07 monthly 0.8 https://www.510kdatabase.net/og-image/k252214-aias-cephalon-fda-510k.jpg K252214 - AIAS Cephalon K252214 is a FDA 510(k) cleared radiology medical device. Manufacturer: Metamorphosis GmbH. Cleared Oct 2025. https://www.510kdatabase.net/k252572/ 2025-10-07 monthly 0.8 https://www.510kdatabase.net/og-image/k252572-prodeon-urethral-sheath-system-fda-510k.jpg K252572 - Prodeon Urethral Sheath System K252572 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Prodeon Medical, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k252851/ 2025-10-07 monthly 0.8 https://www.510kdatabase.net/og-image/k252851-deeplive-osp12-dms-fda-510k.jpg K252851 - deepLive (OSP12 + DMS) K252851 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Damae Medical. Cleared Oct 2025. https://www.510kdatabase.net/k252948/ 2025-10-07 monthly 0.8 https://www.510kdatabase.net/og-image/k252948-truebeam-truebeam-stx-edge-and-vitalbeam-fda-510k.jpg K252948 - TrueBeam, TrueBeam STX, Edge and VitalBeam K252948 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k250173/ 2025-10-06 monthly 0.8 https://www.510kdatabase.net/og-image/k250173-shiley-oral-rae-tracheal-tube-cuffless-fda-510k.jpg K250173 - Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye (113-XX) Shiley™ Nasal RAE Tracheal Tube Cuffless, Murphy Eye (114-XX) Shiley™ Oral RAE Tracheal Tube Cuffed, Murphy Eye (115-XX) Shiley™ Oral RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (115-XXOR) Shiley™ Nasal RAE Tracheal Tube with TaperGuard™ Cuff, Murphy Eye (119-XXNR) K250173 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Covidien, LLC. Cleared Oct 2025. https://www.510kdatabase.net/k251565/ 2025-10-06 monthly 0.8 https://www.510kdatabase.net/og-image/k251565-wheelchair-n817-fda-510k.jpg K251565 - Wheelchair (N817) K251565 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zhejiang Topwe Tools Manufacturing Co.,Ltd. Cleared Oct 2025. https://www.510kdatabase.net/k251603/ 2025-10-06 monthly 0.8 https://www.510kdatabase.net/og-image/k251603-tigertriever-17-ultra-fda-510k.jpg K251603 - Tigertriever 17 Ultra Revascularization Device K251603 is a FDA 510(k) cleared neurology medical device. Manufacturer: Rapid Medical , Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k252007/ 2025-10-06 monthly 0.8 https://www.510kdatabase.net/og-image/k252007-blineslide-fda-510k.jpg K252007 - BlineSlide K252007 is a FDA 510(k) cleared radiology medical device. Manufacturer: Deep Breathe, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k252140/ 2025-10-06 monthly 0.8 https://www.510kdatabase.net/og-image/k252140-heylo-system-fda-510k.jpg K252140 - Heylo™ System K252140 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Coloplast Corp.. Cleared Oct 2025. https://www.510kdatabase.net/k252502/ 2025-10-06 monthly 0.8 https://www.510kdatabase.net/og-image/k252502-folding-mobility-scooter-kd101-fda-510k.jpg K252502 - Folding Mobility Scooter (KD101) K252502 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Nanjing Kangni Smart Technology Co., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/den240073/ 2025-10-06 monthly 0.8 https://www.510kdatabase.net/og-image/den240073-painchek-painchek-adult-fda-510k.jpg DEN240073 - PainChek (PainChek Adult) DEN240073 is a FDA 510(k) cleared neurology medical device. Manufacturer: Painchek Limited (Ltd.). Cleared Oct 2025. https://www.510kdatabase.net/k242946/ 2025-10-03 monthly 0.8 https://www.510kdatabase.net/og-image/k242946-hestia-l200-a-fda-510k.jpg K242946 - HESTIA (L200-A) K242946 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Senbitec Co., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k243968/ 2025-10-03 monthly 0.8 https://www.510kdatabase.net/og-image/k243968-revolve-surgical-system-fda-510k.jpg K243968 - Revolve Surgical System K243968 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Revolve Surgical, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k250028/ 2025-10-03 monthly 0.8 https://www.510kdatabase.net/og-image/k250028-anti-snore-mouthpiece-fda-510k.jpg K250028 - Anti Snore Mouthpiece K250028 is a FDA 510(k) cleared dental medical device. Manufacturer: Dongguan Yiyao Science & Technology Development Co., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k250031/ 2025-10-03 monthly 0.8 https://www.510kdatabase.net/og-image/k250031-amplatzer-guidewire-fda-510k.jpg K250031 - Amplatzer Guidewire K250031 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared Oct 2025. https://www.510kdatabase.net/k250039/ 2025-10-03 monthly 0.8 https://www.510kdatabase.net/og-image/k250039-hpacs-fda-510k.jpg K250039 - HPACS K250039 is a FDA 510(k) cleared radiology medical device. Manufacturer: Healthhub. Cleared Oct 2025. https://www.510kdatabase.net/k250073/ 2025-10-03 monthly 0.8 https://www.510kdatabase.net/og-image/k250073-tosoh-automated-glycohemoglobin-fda-510k.jpg K250073 - Tosoh Automated Glycohemoglobin Analyzer HLC-723GR01 K250073 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Tosoh Bioscience, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k250662/ 2025-10-03 monthly 0.8 https://www.510kdatabase.net/og-image/k250662-bunkerhill-mac-fda-510k.jpg K250662 - Bunkerhill MAC K250662 is a FDA 510(k) cleared radiology medical device. Manufacturer: BunkerHill Health. Cleared Oct 2025. https://www.510kdatabase.net/k251426/ 2025-10-03 monthly 0.8 https://www.510kdatabase.net/og-image/k251426-da-vinci-sp-surgical-system-sp1098-fda-510k.jpg K251426 - da Vinci SP Surgical System (SP1098) K251426 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k251464/ 2025-10-03 monthly 0.8 https://www.510kdatabase.net/og-image/k251464-tri-beam-pro-tri-beam-ndyag-laser-unit-fda-510k.jpg K251464 - TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit) K251464 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Jeisys Medical Incorporated. Cleared Oct 2025. https://www.510kdatabase.net/k251468/ 2025-10-03 monthly 0.8 https://www.510kdatabase.net/og-image/k251468-sleeved-ic-3-family-sleeved-ic-3-swt-fda-510k.jpg K251468 - Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (name not finalized) Sleeved IC 3 Plus Pocket (name not finalized) (N/A) K251468 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hollister Incorporated. Cleared Oct 2025. https://www.510kdatabase.net/k251639/ 2025-10-03 monthly 0.8 https://www.510kdatabase.net/og-image/k251639-xvision-spine-system-fda-510k.jpg K251639 - xvision Spine system K251639 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Augmedics, Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k251646/ 2025-10-03 monthly 0.8 https://www.510kdatabase.net/og-image/k251646-extricare-1000-negative-pressure-wound-fda-510k.jpg K251646 - extriCARE® 1000 Negative Pressure Wound Therapy System K251646 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Alleva Medical Devices. Cleared Oct 2025. https://www.510kdatabase.net/k251859/ 2025-10-03 monthly 0.8 https://www.510kdatabase.net/og-image/k251859-evis-eus-ultrasound-gastrointestinal-fda-510k.jpg K251859 - EVIS EUS Ultrasound Gastrointestinal Videoscope (Olympus GF-UE190) K251859 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Medical Systems Corporation. Cleared Oct 2025. https://www.510kdatabase.net/k252129/ 2025-10-03 monthly 0.8 https://www.510kdatabase.net/og-image/k252129-aetos-shoulder-system-stemless-humeral-fda-510k.jpg K252129 - AETOS Shoulder System Stemless Humeral Prosthesis K252129 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k252178/ 2025-10-03 monthly 0.8 https://www.510kdatabase.net/og-image/k252178-magentiq-colo-me-apds-fda-510k.jpg K252178 - MAGENTIQ-COLO (ME-APDS) K252178 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Magentiq Eye, Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k252517/ 2025-10-03 monthly 0.8 https://www.510kdatabase.net/og-image/k252517-manual-wheelchair-syiv100a008-fda-510k.jpg K252517 - Manual Wheelchair (SYIV100A008) K252517 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Ningbo Shenyu Medical Equipment Co.,Ltd. Cleared Oct 2025. https://www.510kdatabase.net/k252806/ 2025-10-03 monthly 0.8 https://www.510kdatabase.net/og-image/k252806-flexible-suction-ureterorenoscope-fda-510k.jpg K252806 - Flexible Suction Ureterorenoscope (US27G-12-EU, US27G-12-US, US33G-17-EU, US33G-17-US, US38G-20-EU, US38G-20-US.) K252806 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Shanghai AnQing Medical Instrument Co., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k252820/ 2025-10-03 monthly 0.8 https://www.510kdatabase.net/og-image/k252820-pgla90-polyglycolide-co-l-lactide-fda-510k.jpg K252820 - PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso) K252820 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Internacional Farmac?utica S.A DE C.V. Cleared Oct 2025. https://www.510kdatabase.net/den220077/ 2025-10-03 monthly 0.8 https://www.510kdatabase.net/og-image/den220077-prosense-system-fda-510k.jpg DEN220077 - ProSense™ System DEN220077 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Icecure Medical. Cleared Oct 2025. https://www.510kdatabase.net/k243152/ 2025-10-02 monthly 0.8 https://www.510kdatabase.net/og-image/k243152-gelpoint-v-path-transvaginal-access-fda-510k.jpg K243152 - GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access Device K243152 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Applied Medical Resources Corp.. Cleared Oct 2025. https://www.510kdatabase.net/k250523/ 2025-10-02 monthly 0.8 https://www.510kdatabase.net/og-image/k250523-archimedes-pro-automated-peritoneal-fda-510k.jpg K250523 - Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1) K250523 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Simergent, LLC. Cleared Oct 2025. https://www.510kdatabase.net/k250551/ 2025-10-02 monthly 0.8 https://www.510kdatabase.net/og-image/k250551-4k-endoscopic-camera-system-sv-800-sv-fda-510k.jpg K250551 - 4K Endoscopic Camera System (SV-800, SV-800I, SV-800R, SV-800N) K250551 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Sophway Technology Co., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k250766/ 2025-10-02 monthly 0.8 https://www.510kdatabase.net/og-image/k250766-lungq-4-fda-510k.jpg K250766 - LungQ 4 K250766 is a FDA 510(k) cleared radiology medical device. Manufacturer: Thirona BV. Cleared Oct 2025. https://www.510kdatabase.net/k250860/ 2025-10-02 monthly 0.8 https://www.510kdatabase.net/og-image/k250860-breatheband-model-1000-fda-510k.jpg K250860 - BreatheBand® (Model 1000) K250860 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Exemplar Medical, LLC. Cleared Oct 2025. https://www.510kdatabase.net/k251124/ 2025-10-02 monthly 0.8 https://www.510kdatabase.net/og-image/k251124-g-bond-universal-fda-510k.jpg K251124 - G-Bond Universal K251124 is a FDA 510(k) cleared dental medical device. Manufacturer: GC America, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k251215/ 2025-10-02 monthly 0.8 https://www.510kdatabase.net/og-image/k251215-philips-intellispace-cardiovascular-fda-510k.jpg K251215 - Philips IntelliSpace Cardiovascular K251215 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Oct 2025. https://www.510kdatabase.net/k251398/ 2025-10-02 monthly 0.8 https://www.510kdatabase.net/og-image/k251398-ipl-hair-removal-device-ipl-001-ipl-002-fda-510k.jpg K251398 - IPL Hair Removal Device (IPL-001, IPL-002) K251398 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Enmind Technology Co., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k251442/ 2025-10-02 monthly 0.8 https://www.510kdatabase.net/og-image/k251442-tianyi-extracorporeal-blood-tubing-set-fda-510k.jpg K251442 - TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1) K251442 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ningbo Tianyi Medical Appliance Co., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k252059/ 2025-10-02 monthly 0.8 https://www.510kdatabase.net/og-image/k252059-cryovalve-sg-pulmonary-valve-sgpv10-fda-510k.jpg K252059 - CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00) K252059 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Artivion, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k252114/ 2025-10-02 monthly 0.8 https://www.510kdatabase.net/og-image/k252114-mts-aztreonam-avibactam-00164-2564-gml-fda-510k.jpg K252114 - MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL K252114 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Liofilchem S. R. L.. Cleared Oct 2025. https://www.510kdatabase.net/k252440/ 2025-10-02 monthly 0.8 https://www.510kdatabase.net/og-image/k252440-easytelemed-202-fda-510k.jpg K252440 - EasyTeleMed (2.0.2) K252440 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ingeniars S.R.L.. Cleared Oct 2025. https://www.510kdatabase.net/k252758/ 2025-10-02 monthly 0.8 https://www.510kdatabase.net/og-image/k252758-cannulated-screw-and-kirschner-k-wire-fda-510k.jpg K252758 - Cannulated Screw and Kirschner (K wire) System K252758 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthonovis, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k252769/ 2025-10-02 monthly 0.8 https://www.510kdatabase.net/og-image/k252769-upper-arm-electronic-blood-pressure-fda-510k.jpg K252769 - Upper Arm Electronic Blood Pressure Monitor (FC-BP107, FC-BP123, FC-BP125, FC-BP126, FC-BP127, FC-BP116) K252769 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Finicare Co., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k250026/ 2025-10-01 monthly 0.8 https://www.510kdatabase.net/og-image/k250026-shear-wave-quantificational-ultrasound-fda-510k.jpg K250026 - Shear Wave Quantificational Ultrasound Diagnostic System (FH9000/FH7000/FH6000/FH5000/FH3000/FH1000) K250026 is a FDA 510(k) cleared radiology medical device. Manufacturer: Wuxi Hisky Medical Technologies Co., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k250083/ 2025-10-01 monthly 0.8 https://www.510kdatabase.net/og-image/k250083-pro-dose-system-fda-510k.jpg K250083 - PRO-DOSE System K250083 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nu-Rise, SA. Cleared Oct 2025. https://www.510kdatabase.net/k250767/ 2025-10-01 monthly 0.8 https://www.510kdatabase.net/og-image/k250767-newclip-patient-matched-fda-510k.jpg K250767 - Newclip Patient-matched instrumentation non sterile PSI K250767 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Newclip Technics. Cleared Oct 2025. https://www.510kdatabase.net/k251501/ 2025-10-01 monthly 0.8 https://www.510kdatabase.net/og-image/k251501-visby-medical-mens-sexual-health-test-fda-510k.jpg K251501 - Visby Medical Men's Sexual Health Test K251501 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Visby Medical, Inc.. Cleared Oct 2025. https://www.510kdatabase.net/k251767/ 2025-10-01 monthly 0.8 https://www.510kdatabase.net/og-image/k251767-vena-microangioscope-system-fda-510k.jpg K251767 - Vena MicroAngioscope™ System K251767 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vena Medical Holdings Corp. Cleared Oct 2025. https://www.510kdatabase.net/k251825/ 2025-10-01 monthly 0.8 https://www.510kdatabase.net/og-image/k251825-jmoon-flexglow-light-therapy-device-fda-510k.jpg K251825 - Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG) K251825 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Ulike Smart Electronics Co., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k251899/ 2025-10-01 monthly 0.8 https://www.510kdatabase.net/og-image/k251899-e-blator-fda-510k.jpg K251899 - E Blator K251899 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: New Deantronics Taiwan , Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k252096/ 2025-10-01 monthly 0.8 https://www.510kdatabase.net/og-image/k252096-light-therapy-decollete-mask-1019135-fda-510k.jpg K252096 - Light Therapy Decollete Mask (1019135) K252096 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Merchsource, LLC. Cleared Oct 2025. https://www.510kdatabase.net/k252447/ 2025-10-01 monthly 0.8 https://www.510kdatabase.net/og-image/k252447-picosecond-laser-device-bmps4-fda-510k.jpg K252447 - Picosecond laser device (BMPS4) K252447 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Hebei Newangie Technology Co., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k252804/ 2025-10-01 monthly 0.8 https://www.510kdatabase.net/og-image/k252804-ice-cooling-ipl-hair-removal-device-fda-510k.jpg K252804 - Ice Cooling IPL Hair Removal Device (UI20S BK, UI20S BS, UI20S DB, UI20S GP, UI20S GR, UI20S MP, UI20S PW, UI20S RE, UI20S WH, UI20WG K252804 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Ulike Smart Electronics Co., Ltd.. Cleared Oct 2025. https://www.510kdatabase.net/k243270/ 2025-09-30 monthly 0.8 https://www.510kdatabase.net/og-image/k243270-tigerconnect-alarm-management-fda-510k.jpg K243270 - TigerConnect Alarm Management K243270 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Tigerconnect. Cleared Sep 2025. https://www.510kdatabase.net/k250050/ 2025-09-30 monthly 0.8 https://www.510kdatabase.net/og-image/k250050-midiagnostics-hsv-12-csf-test-fda-510k.jpg K250050 - miDiagnostics HSV-1&2 CSF Test K250050 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Midiagnostics NV. Cleared Sep 2025. https://www.510kdatabase.net/k250331/ 2025-09-30 monthly 0.8 https://www.510kdatabase.net/og-image/k250331-astrasono-a3pro-bladder-scanner-a3pro-fda-510k.jpg K250331 - Astrasono A3Pro Bladder Scanner (A3Pro) K250331 is a FDA 510(k) cleared radiology medical device. Manufacturer: Astrasono Technology Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k251197/ 2025-09-30 monthly 0.8 https://www.510kdatabase.net/og-image/k251197-dexter-l6-system-fda-510k.jpg K251197 - Dexter L6 System K251197 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Distalmotion SA. Cleared Sep 2025. https://www.510kdatabase.net/k251669/ 2025-09-30 monthly 0.8 https://www.510kdatabase.net/og-image/k251669-ibp-transducer-adapter-cable-fda-510k.jpg K251669 - IBP transducer adapter cable, Argon/BD/Ohmeda, 2m K251669 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shanghai Draeger Medical Instrument Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k251690/ 2025-09-30 monthly 0.8 https://www.510kdatabase.net/og-image/k251690-arthrex-speedflex-implant-fda-510k.jpg K251690 - Arthrex SpeedFLEX™ Implant K251690 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k251799/ 2025-09-30 monthly 0.8 https://www.510kdatabase.net/og-image/k251799-mobility-scooter-bbr-q40-01-fda-510k.jpg K251799 - Mobility Scooter (BBR-Q40-01) K251799 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Jiangsu Bangbang Intelligent Technology Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k252072/ 2025-09-30 monthly 0.8 https://www.510kdatabase.net/og-image/k252072-francisella-tularensis-real-time-pcr-fda-510k.jpg K252072 - Francisella tularensis Real-time PCR assay K252072 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Centers For Disease Control and Prevention. Cleared Sep 2025. https://www.510kdatabase.net/k252085/ 2025-09-30 monthly 0.8 https://www.510kdatabase.net/og-image/k252085-allomatrix-allomatrix-injectable-putty-fda-510k.jpg K252085 - Allomatrix (Allomatrix Injectable Putty K252085 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wright Medical Technology, Inc. (Stryker Corporation). Cleared Sep 2025. https://www.510kdatabase.net/k252106/ 2025-09-30 monthly 0.8 https://www.510kdatabase.net/og-image/k252106-external-fixation-mini-rail-system-fda-510k.jpg K252106 - External Fixation Mini Rail System K252106 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paragon 28, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k252722/ 2025-09-30 monthly 0.8 https://www.510kdatabase.net/og-image/k252722-biopsy-forceps-fda-510k.jpg K252722 - Biopsy Forceps K252722 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Fehling Instruments GmbH. Cleared Sep 2025. https://www.510kdatabase.net/k243833/ 2025-09-29 monthly 0.8 https://www.510kdatabase.net/og-image/k243833-portable-oxygen-concentrator-jay-1000p-fda-510k.jpg K243833 - Portable oxygen concentrator (JAY-1000P) K243833 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Longfian Scitech Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k243983/ 2025-09-29 monthly 0.8 https://www.510kdatabase.net/og-image/k243983-paltop-dental-implant-system-fda-510k.jpg K243983 - Paltop Dental Implant System K243983 is a FDA 510(k) cleared dental medical device. Manufacturer: Paltop Advanced Dental Solutions, Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k250023/ 2025-09-29 monthly 0.8 https://www.510kdatabase.net/og-image/k250023-smart-pcfd-fda-510k.jpg K250023 - SMART PCFD K250023 is a FDA 510(k) cleared radiology medical device. Manufacturer: Disior, Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k250123/ 2025-09-29 monthly 0.8 https://www.510kdatabase.net/og-image/k250123-master-pin-x-mp-pin-with-thread-fda-510k.jpg K250123 - Master-Pin X (MP Pin with thread) (36BMP000030 / MP30) K250123 is a FDA 510(k) cleared dental medical device. Manufacturer: Hager& Meisinger GmbH. Cleared Sep 2025. https://www.510kdatabase.net/k251104/ 2025-09-29 monthly 0.8 https://www.510kdatabase.net/og-image/k251104-suretome-sw-sphincterotome-with-dometip-fda-510k.jpg K251104 - SureTome™ SW Sphincterotome with DomeTip K251104 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Wilson Cook Medical. Cleared Sep 2025. https://www.510kdatabase.net/k251334/ 2025-09-29 monthly 0.8 https://www.510kdatabase.net/og-image/k251334-new-doublo-20-fda-510k.jpg K251334 - NEW DOUBLO 2.0 K251334 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Hironic Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k252051/ 2025-09-29 monthly 0.8 https://www.510kdatabase.net/og-image/k252051-allay-nerve-cap-tl5515-1-fda-510k.jpg K252051 - allay Nerve Cap (TL5515-1) K252051 is a FDA 510(k) cleared neurology medical device. Manufacturer: Tulavi Therapeutics, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k252054/ 2025-09-29 monthly 0.8 https://www.510kdatabase.net/og-image/k252054-spinear-snap-syncar-spine-fda-510k.jpg K252054 - SpineAR SNAP (SyncAR Spine) K252054 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Surgical Theater, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k252441/ 2025-09-29 monthly 0.8 https://www.510kdatabase.net/og-image/k252441-primero-safe-access-system-fda-510k.jpg K252441 - Primero Safe Access System K252441 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: South53, LLC. Cleared Sep 2025. https://www.510kdatabase.net/k252594/ 2025-09-29 monthly 0.8 https://www.510kdatabase.net/og-image/k252594-ultraguidectr-image-guided-soft-tissue-fda-510k.jpg K252594 - UltraGuideCTR® image guided soft tissue release system K252594 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Sonex Health. Cleared Sep 2025. https://www.510kdatabase.net/k252770/ 2025-09-29 monthly 0.8 https://www.510kdatabase.net/og-image/k252770-ilet-ace-pump-fda-510k.jpg K252770 - iLet ACE Pump K252770 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beta Bionics, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k253236/ 2025-09-29 monthly 0.8 https://www.510kdatabase.net/og-image/k253236-g-block-fda-510k.jpg K253236 - G-BLOCK K253236 is a FDA 510(k) cleared dental medical device. Manufacturer: Graphenano Dental S.L.. Cleared Sep 2025. https://www.510kdatabase.net/k250093/ 2025-09-26 monthly 0.8 https://www.510kdatabase.net/og-image/k250093-linshom-continuous-predictive-fda-510k.jpg K250093 - Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) K250093 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Linshom Medical, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k250318/ 2025-09-26 monthly 0.8 https://www.510kdatabase.net/og-image/k250318-planmed-xfi-fda-510k.jpg K250318 - Planmed XFI K250318 is a FDA 510(k) cleared radiology medical device. Manufacturer: Planmed OY. Cleared Sep 2025. https://www.510kdatabase.net/k250659/ 2025-09-26 monthly 0.8 https://www.510kdatabase.net/og-image/k250659-lofric-origo-fda-510k.jpg K250659 - LoFric Origo K250659 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Wellspect AB. Cleared Sep 2025. https://www.510kdatabase.net/k251204/ 2025-09-26 monthly 0.8 https://www.510kdatabase.net/og-image/k251204-fujifilm-stiffening-wire-device-sw-2000-fda-510k.jpg K251204 - FUJIFILM Stiffening Wire Device (SW-2000) K251204 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fujifilm Healthcare Americas Corporation. Cleared Sep 2025. https://www.510kdatabase.net/k251208/ 2025-09-26 monthly 0.8 https://www.510kdatabase.net/og-image/k251208-tuned-self-fitting-mobile-app-fda-510k.jpg K251208 - Tuned Self-Fitting Mobile App K251208 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Tuned , Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k251262/ 2025-09-26 monthly 0.8 https://www.510kdatabase.net/og-image/k251262-sin-dental-implant-system-fda-510k.jpg K251262 - S.I.N. Dental Implant System K251262 is a FDA 510(k) cleared dental medical device. Manufacturer: S.I.N. Implant System Ltda. Cleared Sep 2025. https://www.510kdatabase.net/k251275/ 2025-09-26 monthly 0.8 https://www.510kdatabase.net/og-image/k251275-vitalstream-art-connect-fda-510k.jpg K251275 - VitalStream ART Connect K251275 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Caretaker Medical. Cleared Sep 2025. https://www.510kdatabase.net/k251645/ 2025-09-26 monthly 0.8 https://www.510kdatabase.net/og-image/k251645-self-propelled-ct-scan-base-kit-cgba-fda-510k.jpg K251645 - Self-Propelled CT Scan Base Kit, CGBA-035A K251645 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Sep 2025. https://www.510kdatabase.net/k251919/ 2025-09-26 monthly 0.8 https://www.510kdatabase.net/og-image/k251919-thulium-laser-system-deluxlase-fda-510k.jpg K251919 - Thulium Laser System (Deluxlase) K251919 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Nanjing Bestview Laser S&T Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k251986/ 2025-09-26 monthly 0.8 https://www.510kdatabase.net/og-image/k251986-auxiliary-water-tube-maj-855-fda-510k.jpg K251986 - AUXILIARY WATER TUBE MAJ-855 K251986 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Medical Systems Corporation. Cleared Sep 2025. https://www.510kdatabase.net/k252105/ 2025-09-26 monthly 0.8 https://www.510kdatabase.net/og-image/k252105-ligence-heart-fda-510k.jpg K252105 - Ligence Heart K252105 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ligence Uab. Cleared Sep 2025. https://www.510kdatabase.net/k252221/ 2025-09-26 monthly 0.8 https://www.510kdatabase.net/og-image/k252221-inset-reverse-total-shoulder-system-fda-510k.jpg K252221 - Inset Reverse Total Shoulder System K252221 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Shoulder Innovations, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k252435/ 2025-09-26 monthly 0.8 https://www.510kdatabase.net/og-image/k252435-magnetic-surgical-system-fda-510k.jpg K252435 - Magnetic Surgical System K252435 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Levita Magnetics International Corp. Cleared Sep 2025. https://www.510kdatabase.net/k252700/ 2025-09-26 monthly 0.8 https://www.510kdatabase.net/og-image/k252700-optima-coil-system-optima-packing-coil-fda-510k.jpg K252700 - Optima Coil System (Optima Packing Coil System) K252700 is a FDA 510(k) cleared neurology medical device. Manufacturer: Balt USA, LLC. Cleared Sep 2025. https://www.510kdatabase.net/k252921/ 2025-09-26 monthly 0.8 https://www.510kdatabase.net/og-image/k252921-radial-jaw-4-pulmonary-biopsy-forceps-fda-510k.jpg K252921 - Radial Jaw 4 Pulmonary Biopsy Forceps K252921 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Boston Scientific Corporation. Cleared Sep 2025. https://www.510kdatabase.net/k243785/ 2025-09-25 monthly 0.8 https://www.510kdatabase.net/og-image/k243785-shiley-oralnasal-tracheal-tube-with-fda-510k.jpg K243785 - Shiley™ Oral/Nasal Tracheal Tube with TaperGuard™ Cuff Reinforced, Murphy Eye Shiley™ Tracheal Tube TaperGuard™ Cuff Reinforced with Stylet Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced Shiley™ Lo-Contour Oral/Nasal Tracheal Tube Cuffed Reinforced, Murphy Eye Shiley™ Oral/Nasal Tracheal Tube Cuffless Reinforced K243785 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Covidien, LLC. Cleared Sep 2025. https://www.510kdatabase.net/k244009/ 2025-09-25 monthly 0.8 https://www.510kdatabase.net/og-image/k244009-pure-plus-uv-aspheric-otufilcon-a-fda-510k.jpg K244009 - Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear (Daily Wear) K244009 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Yung Sheng Optical Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k250076/ 2025-09-25 monthly 0.8 https://www.510kdatabase.net/og-image/k250076-endeavor-stand-alone-cervical-ibf-system-fda-510k.jpg K250076 - Endeavor™ Stand-Alone Cervical IBF System K250076 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Innovasis. Cleared Sep 2025. https://www.510kdatabase.net/k250837/ 2025-09-25 monthly 0.8 https://www.510kdatabase.net/og-image/k250837-pulse-oximeter-fda-510k.jpg K250837 - Pulse Oximeter K250837 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shanghai Berry Electronic Tech Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k251148/ 2025-09-25 monthly 0.8 https://www.510kdatabase.net/og-image/k251148-jdevolution-plus-l-and-jdevolution-fda-510k.jpg K251148 - JDEvolution Plus L and JDEvolution Plus LE K251148 is a FDA 510(k) cleared dental medical device. Manufacturer: Jdentalcare Srl. Cleared Sep 2025. https://www.510kdatabase.net/k251465/ 2025-09-25 monthly 0.8 https://www.510kdatabase.net/og-image/k251465-root-canal-repair-materials-nroot-bp-fda-510k.jpg K251465 - Root canal repair materials (nRoot BP) K251465 is a FDA 510(k) cleared dental medical device. Manufacturer: Enpuno Biotechnology Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k251512/ 2025-09-25 monthly 0.8 https://www.510kdatabase.net/og-image/k251512-hi-bebe-super-bt-150b-fda-510k.jpg K251512 - Hi bebe super (BT-150B) K251512 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Bistos Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k251527/ 2025-09-25 monthly 0.8 https://www.510kdatabase.net/og-image/k251527-brain-wmh-fda-510k.jpg K251527 - Brain WMH K251527 is a FDA 510(k) cleared radiology medical device. Manufacturer: Quantib B.V.. Cleared Sep 2025. https://www.510kdatabase.net/k251789/ 2025-09-25 monthly 0.8 https://www.510kdatabase.net/og-image/k251789-embotrap-iii-revascularization-device-fda-510k.jpg K251789 - EMBOTRAP III Revascularization Device K251789 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neuravi Limited. Cleared Sep 2025. https://www.510kdatabase.net/k251791/ 2025-09-25 monthly 0.8 https://www.510kdatabase.net/og-image/k251791-auxano-wedge-fixation-system-fda-510k.jpg K251791 - Auxano® Wedge Fixation System K251791 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Auxano Medical, LLC. Cleared Sep 2025. https://www.510kdatabase.net/k251812/ 2025-09-25 monthly 0.8 https://www.510kdatabase.net/og-image/k251812-steripath-flow-blood-collection-system-fda-510k.jpg K251812 - Steripath® Flow™ Blood Collection System K251812 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Magnolia Medical Technologies. Cleared Sep 2025. https://www.510kdatabase.net/k251868/ 2025-09-25 monthly 0.8 https://www.510kdatabase.net/og-image/k251868-panther-fusion-gi-bacterial-assay-fda-510k.jpg K251868 - Panther Fusion GI Bacterial Assay K251868 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Hologic. Cleared Sep 2025. https://www.510kdatabase.net/k251971/ 2025-09-25 monthly 0.8 https://www.510kdatabase.net/og-image/k251971-rps-primary-tka-software-fda-510k.jpg K251971 - RPS Primary TKA Software K251971 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Instruments. Cleared Sep 2025. https://www.510kdatabase.net/k251993/ 2025-09-25 monthly 0.8 https://www.510kdatabase.net/og-image/k251993-panther-fusion-gi-expanded-bacterial-fda-510k.jpg K251993 - Panther Fusion GI Expanded Bacterial Assay K251993 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Hologic, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k251997/ 2025-09-25 monthly 0.8 https://www.510kdatabase.net/og-image/k251997-single-use-biopsy-valve-maj-1555-fda-510k.jpg K251997 - Single-Use Biopsy Valve (MAJ-1555) K251997 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Medical Systems Corporation. Cleared Sep 2025. https://www.510kdatabase.net/k252013/ 2025-09-25 monthly 0.8 https://www.510kdatabase.net/og-image/k252013-ensite-x-ep-system-fda-510k.jpg K252013 - EnSite™ X EP System K252013 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared Sep 2025. https://www.510kdatabase.net/k252062/ 2025-09-25 monthly 0.8 https://www.510kdatabase.net/og-image/k252062-the-sensititre-18-24-hour-mic-or-fda-510k.jpg K252062 - The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the dilution range of 0.12-16 ug/mL K252062 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Thermo Fisher Scientific. Cleared Sep 2025. https://www.510kdatabase.net/k252063/ 2025-09-25 monthly 0.8 https://www.510kdatabase.net/og-image/k252063-medical-diode-laser-systems-berylas-12n-fda-510k.jpg K252063 - Medical Diode Laser Systems (BERYLAS-12N) K252063 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wuhan Dimed Laser Technology Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k252102/ 2025-09-25 monthly 0.8 https://www.510kdatabase.net/og-image/k252102-alinity-m-hcv-fda-510k.jpg K252102 - Alinity m HCV K252102 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Molecular, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k252371/ 2025-09-25 monthly 0.8 https://www.510kdatabase.net/og-image/k252371-umr-680-fda-510k.jpg K252371 - uMR 680 K252371 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k252725/ 2025-09-25 monthly 0.8 https://www.510kdatabase.net/og-image/k252725-stem-extension-line-u2-total-knee-fda-510k.jpg K252725 - Stem Extension Line (U2 Total Knee System—PSA Type) K252725 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: United Orthopedic Corporation. Cleared Sep 2025. https://www.510kdatabase.net/den250016/ 2025-09-25 monthly 0.8 https://www.510kdatabase.net/og-image/den250016-essilor-stellest-fda-510k.jpg DEN250016 - Essilor® Stellest® DEN250016 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Essilor of America, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k243910/ 2025-09-24 monthly 0.8 https://www.510kdatabase.net/og-image/k243910-retraxil-fda-510k.jpg K243910 - Retraxil K243910 is a FDA 510(k) cleared dental medical device. Manufacturer: Kulzer, LLC. Cleared Sep 2025. https://www.510kdatabase.net/k244029/ 2025-09-24 monthly 0.8 https://www.510kdatabase.net/og-image/k244029-robopera-er-r-002-fda-510k.jpg K244029 - ROBOPERA (ER-R-002) K244029 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Endorobotics Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k250045/ 2025-09-24 monthly 0.8 https://www.510kdatabase.net/og-image/k250045-uws-angio-pro-fda-510k.jpg K250045 - uWS-Angio Pro K250045 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k250071/ 2025-09-24 monthly 0.8 https://www.510kdatabase.net/og-image/k250071-alma-femilift-pixel-co2-laser-system-fda-510k.jpg K250071 - Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories K250071 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Alma Lasers, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k250792/ 2025-09-24 monthly 0.8 https://www.510kdatabase.net/og-image/k250792-tslim-x2-insulin-pump-with-fda-510k.jpg K250792 - t:slim X2 insulin pump with interoperable technology K250792 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Tandem Diabetes Care, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k251206/ 2025-09-24 monthly 0.8 https://www.510kdatabase.net/og-image/k251206-digital-x-ray-dentimax-pro-imaging-fda-510k.jpg K251206 - Digital X-Ray DentiMax Pro Imaging System K251206 is a FDA 510(k) cleared radiology medical device. Manufacturer: Dentimax, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k251734/ 2025-09-24 monthly 0.8 https://www.510kdatabase.net/og-image/k251734-provee-video-processing-unit-pv-003-fda-510k.jpg K251734 - ProVee Video Processing Unit (PV-003) K251734 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Proverum Limited. Cleared Sep 2025. https://www.510kdatabase.net/k252183/ 2025-09-24 monthly 0.8 https://www.510kdatabase.net/og-image/k252183-resitu-slider-09-resl09-fda-510k.jpg K252183 - Resitu Slider 09 (RESL09) K252183 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Resitu Medical AB. Cleared Sep 2025. https://www.510kdatabase.net/k252227/ 2025-09-24 monthly 0.8 https://www.510kdatabase.net/og-image/k252227-pouncetm-sheath-fda-510k.jpg K252227 - Pounce(TM) Sheath K252227 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Surmodics,Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k252680/ 2025-09-24 monthly 0.8 https://www.510kdatabase.net/og-image/k252680-celerity-20-hp-biological-indicator-fda-510k.jpg K252680 - Celerity™ 20 HP Biological Indicator K252680 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Sep 2025. https://www.510kdatabase.net/k252682/ 2025-09-24 monthly 0.8 https://www.510kdatabase.net/og-image/k252682-lensx-laser-system-8065000944-fda-510k.jpg K252682 - LenSx Laser System (8065000944) K252682 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Alcon Laboratories, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k252689/ 2025-09-24 monthly 0.8 https://www.510kdatabase.net/og-image/k252689-medrad-centargo-ct-injection-system-fda-510k.jpg K252689 - MEDRAD Centargo CT Injection System K252689 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Imaxeon Pty, Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k252703/ 2025-09-24 monthly 0.8 https://www.510kdatabase.net/og-image/k252703-lithovue-elite-single-use-digital-fda-510k.jpg K252703 - LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000) K252703 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Sep 2025. https://www.510kdatabase.net/k250209/ 2025-09-23 monthly 0.8 https://www.510kdatabase.net/og-image/k250209-polyvinyl-alcohol-embolic-microspheres-fda-510k.jpg K250209 - Polyvinyl Alcohol Embolic Microspheres K250209 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Canyon Medical, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k251140/ 2025-09-23 monthly 0.8 https://www.510kdatabase.net/og-image/k251140-zenflow-spring-scope-fda-510k.jpg K251140 - Zenflow Spring Scope K251140 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Zenflow, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k251483/ 2025-09-23 monthly 0.8 https://www.510kdatabase.net/og-image/k251483-swiftsight-brain-fda-510k.jpg K251483 - SwiftSight-Brain K251483 is a FDA 510(k) cleared radiology medical device. Manufacturer: Airs Medical, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k251894/ 2025-09-23 monthly 0.8 https://www.510kdatabase.net/og-image/k251894-himaging-bronchscope-system-fda-510k.jpg K251894 - Himaging Bronchscope System K251894 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Himaging Technology (Shanghai) Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k251973/ 2025-09-23 monthly 0.8 https://www.510kdatabase.net/og-image/k251973-luminance-red-cold-sore-device-tn1927g-fda-510k.jpg K251973 - Luminance Red Cold Sore Device (TN1927G) K251973 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Luminance Medical Ventures, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k251982/ 2025-09-23 monthly 0.8 https://www.510kdatabase.net/og-image/k251982-edwards-mc3-tricuspid-annuloplasty-fda-510k.jpg K251982 - Edwards MC3 Tricuspid annuloplasty ring (4900) K251982 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Sep 2025. https://www.510kdatabase.net/k251987/ 2025-09-23 monthly 0.8 https://www.510kdatabase.net/og-image/k251987-rapid-aortic-measurements-fda-510k.jpg K251987 - Rapid Aortic Measurements K251987 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ischemaview, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k252043/ 2025-09-23 monthly 0.8 https://www.510kdatabase.net/og-image/k252043-bipolar-applicator-celonprobreath-fda-510k.jpg K252043 - Bipolar applicator CelonProBreath (WB990310) K252043 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Olympus Winter & Ibe GmbH. Cleared Sep 2025. https://www.510kdatabase.net/k252045/ 2025-09-23 monthly 0.8 https://www.510kdatabase.net/og-image/k252045-ion-endoluminal-system-if1000-fda-510k.jpg K252045 - Ion Endoluminal System (IF1000) K252045 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k252644/ 2025-09-23 monthly 0.8 https://www.510kdatabase.net/og-image/k252644-pinion-pdo-knotless-suture-absorbable-fda-510k.jpg K252644 - PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture K252644 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: M/s. Meril Endo Surgery Private Limited.. Cleared Sep 2025. https://www.510kdatabase.net/k253053/ 2025-09-23 monthly 0.8 https://www.510kdatabase.net/og-image/k253053-dura-crown-cb21-a1cb21-a2cb21-a3cb21-b1-fda-510k.jpg K253053 - Dura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) K253053 is a FDA 510(k) cleared dental medical device. Manufacturer: Hangzhou SHINING3D Dental Technology Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/den240080/ 2025-09-23 monthly 0.8 https://www.510kdatabase.net/og-image/den240080-biolinq-shine-autonomous-time-in-range-fda-510k.jpg DEN240080 - Biolinq Shine Autonomous Time-in-Range Microsensor DEN240080 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Biolinq Incorporated. Cleared Sep 2025. https://www.510kdatabase.net/k243645/ 2025-09-22 monthly 0.8 https://www.510kdatabase.net/og-image/k243645-ic-flow-imaging-system-20-fda-510k.jpg K243645 - IC-Flow™ Imaging System 2.0 K243645 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Diagnostic Green GmbH. Cleared Sep 2025. https://www.510kdatabase.net/k250205/ 2025-09-22 monthly 0.8 https://www.510kdatabase.net/og-image/k250205-babio-virus-transport-kit-non-fda-510k.jpg K250205 - Babio® Virus Transport Kit (Non-inactivating) K250205 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Jinan Babio Biotechnology Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k250388/ 2025-09-22 monthly 0.8 https://www.510kdatabase.net/og-image/k250388-endoflator-fda-510k.jpg K250388 - ENDOFLATOR + K250388 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Karl Storz SE & CO. KG. Cleared Sep 2025. https://www.510kdatabase.net/k251743/ 2025-09-22 monthly 0.8 https://www.510kdatabase.net/og-image/k251743-spi-laprosac-laparoscopic-single-use-fda-510k.jpg K251743 - SPI LaproSac™ Laparoscopic Single-Use Rip-Stop Nylon Specimen Retrieval System K251743 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Surgical Principals, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k252315/ 2025-09-22 monthly 0.8 https://www.510kdatabase.net/og-image/k252315-santreva-atk-endovascular-fda-510k.jpg K252315 - Santreva™-ATK Endovascular Revasculariztion Catheter K252315 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: AngioSafe, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k241868/ 2025-09-19 monthly 0.8 https://www.510kdatabase.net/og-image/k241868-xr-ivd-fda-510k.jpg K241868 - xR IVD K241868 is a FDA 510(k) cleared pathology medical device. Manufacturer: Tempus AI, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k242859/ 2025-09-19 monthly 0.8 https://www.510kdatabase.net/og-image/k242859-vega-fda-510k.jpg K242859 - VEGA K242859 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ibramed Equipamentos M?dicos. Cleared Sep 2025. https://www.510kdatabase.net/k243920/ 2025-09-19 monthly 0.8 https://www.510kdatabase.net/og-image/k243920-purema-h-hemoconcentrator-pediatric-fda-510k.jpg K243920 - Purema H Hemoconcentrator - Pediatric K243920 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medica USA, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k243990/ 2025-09-19 monthly 0.8 https://www.510kdatabase.net/og-image/k243990-bondease-2-topical-skin-adhesive-fda-510k.jpg K243990 - BondEase 2 Topical Skin Adhesive K243990 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Optmed, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k244035/ 2025-09-19 monthly 0.8 https://www.510kdatabase.net/og-image/k244035-portable-mesh-nebulizer-jm821-fda-510k.jpg K244035 - Portable mesh nebulizer (JM821) K244035 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Jermei Medical Device Technology Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k250128/ 2025-09-19 monthly 0.8 https://www.510kdatabase.net/og-image/k250128-single-use-suction-evacuation-ureteral-fda-510k.jpg K250128 - Single Use Suction-Evacuation Ureteral Access Sheath K250128 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Anhui Happiness Workshop Medical Instruments Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k250408/ 2025-09-19 monthly 0.8 https://www.510kdatabase.net/og-image/k250408-alegria-flash-ena-screen-fda-510k.jpg K250408 - Alegria Flash ENA Screen K250408 is a FDA 510(k) cleared immunology medical device. Manufacturer: Zeus Scientific. Cleared Sep 2025. https://www.510kdatabase.net/k250450/ 2025-09-19 monthly 0.8 https://www.510kdatabase.net/og-image/k250450-coated-hip-implants-fda-510k.jpg K250450 - Coated hip implants K250450 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Sep 2025. https://www.510kdatabase.net/k250649/ 2025-09-19 monthly 0.8 https://www.510kdatabase.net/og-image/k250649-bunkerhill-ecg-ef-fda-510k.jpg K250649 - Bunkerhill ECG-EF K250649 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: BunkerHill Health. Cleared Sep 2025. https://www.510kdatabase.net/k250777/ 2025-09-19 monthly 0.8 https://www.510kdatabase.net/og-image/k250777-sonicaid-team3-fda-510k.jpg K250777 - Sonicaid Team3 K250777 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Huntleigh Healthcare , Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k250953/ 2025-09-19 monthly 0.8 https://www.510kdatabase.net/og-image/k250953-equia-lc-one-fda-510k.jpg K250953 - EQUIA LC ONE K250953 is a FDA 510(k) cleared dental medical device. Manufacturer: GC America, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k251002/ 2025-09-19 monthly 0.8 https://www.510kdatabase.net/og-image/k251002-videa-dental-ai-fda-510k.jpg K251002 - Videa Dental AI K251002 is a FDA 510(k) cleared radiology medical device. Manufacturer: Videahealth, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k251100/ 2025-09-19 monthly 0.8 https://www.510kdatabase.net/og-image/k251100-ipgtfl-02-fda-510k.jpg K251100 - IPGTFL-02 K251100 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ipg Medical Corporation. Cleared Sep 2025. https://www.510kdatabase.net/k251167/ 2025-09-19 monthly 0.8 https://www.510kdatabase.net/og-image/k251167-udr-aurora-cx-fda-510k.jpg K251167 - uDR Aurora CX K251167 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k251689/ 2025-09-19 monthly 0.8 https://www.510kdatabase.net/og-image/k251689-varios-170-lux-scaler-system-va170luxs10-fda-510k.jpg K251689 - VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10) K251689 is a FDA 510(k) cleared dental medical device. Manufacturer: Nakanishi, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k251867/ 2025-09-19 monthly 0.8 https://www.510kdatabase.net/og-image/k251867-evis-exera-iii-duodenovideoscope-fda-510k.jpg K251867 - EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V (TJF-Q190V) K251867 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Sep 2025. https://www.510kdatabase.net/k252285/ 2025-09-19 monthly 0.8 https://www.510kdatabase.net/og-image/k252285-well-root-pt-fda-510k.jpg K252285 - Well-Root PT K252285 is a FDA 510(k) cleared dental medical device. Manufacturer: Vericom Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k252613/ 2025-09-19 monthly 0.8 https://www.510kdatabase.net/og-image/k252613-unscented-menstrual-three-piece-fda-510k.jpg K252613 - Unscented menstrual three-piece applicator tampon K252613 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Unibeauty (Hubei) Technology Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k252647/ 2025-09-19 monthly 0.8 https://www.510kdatabase.net/og-image/k252647-tapestry-biointegrative-implant-fda-510k.jpg K252647 - Tapestry Biointegrative Implant K252647 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Embody, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k252657/ 2025-09-19 monthly 0.8 https://www.510kdatabase.net/og-image/k252657-impact-peek-union-nail-system-fda-510k.jpg K252657 - Impact PEEK Union Nail System K252657 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nvision Biomedical Technologies, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k252662/ 2025-09-19 monthly 0.8 https://www.510kdatabase.net/og-image/k252662-unibur-fda-510k.jpg K252662 - UniBur K252662 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nakanishi, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/den240067/ 2025-09-19 monthly 0.8 https://www.510kdatabase.net/og-image/den240067-kmt2a-breakapart-fish-probe-kit-pdx-fda-510k.jpg DEN240067 - KMT2A Breakapart FISH Probe Kit PDx (CDA-LPH013) DEN240067 is a FDA 510(k) cleared medical genetics medical device. Manufacturer: Cytocell Limited. Cleared Sep 2025. https://www.510kdatabase.net/k250369/ 2025-09-18 monthly 0.8 https://www.510kdatabase.net/og-image/k250369-axial3d-insight-fda-510k.jpg K250369 - Axial3D Insight K250369 is a FDA 510(k) cleared radiology medical device. Manufacturer: Axial Medical Printing Limited. Cleared Sep 2025. https://www.510kdatabase.net/k250883/ 2025-09-18 monthly 0.8 https://www.510kdatabase.net/og-image/k250883-ultrasonic-probe-um-3r-um-3r-fda-510k.jpg K250883 - ULTRASONIC PROBE UM-3R (UM-3R) K250883 is a FDA 510(k) cleared radiology medical device. Manufacturer: Olympus Medical Systems Corporation. Cleared Sep 2025. https://www.510kdatabase.net/k251377/ 2025-09-18 monthly 0.8 https://www.510kdatabase.net/og-image/k251377-magic-inbra-fda-510k.jpg K251377 - Magic InBra K251377 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Medela AG. Cleared Sep 2025. https://www.510kdatabase.net/k251479/ 2025-09-18 monthly 0.8 https://www.510kdatabase.net/og-image/k251479-mobarn-8020-lumbar-interbody-fusion-fda-510k.jpg K251479 - Mobarn 80:20 Lumbar Interbody Fusion System (Posterior Lumbar Interbody Fusion Cage (PLIF)) K251479 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Mobarn Medical Devices, LLC. Cleared Sep 2025. https://www.510kdatabase.net/k251597/ 2025-09-18 monthly 0.8 https://www.510kdatabase.net/og-image/k251597-innerview-system-fda-510k.jpg K251597 - InnerView System K251597 is a FDA 510(k) cleared dental medical device. Manufacturer: Perimetrics, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k251649/ 2025-09-18 monthly 0.8 https://www.510kdatabase.net/og-image/k251649-sunny-plus-sunny-fda-510k.jpg K251649 - Sunny Plus (Sunny) K251649 is a FDA 510(k) cleared neurology medical device. Manufacturer: ShenB Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k251905/ 2025-09-18 monthly 0.8 https://www.510kdatabase.net/og-image/k251905-normatec-elite-hip-fda-510k.jpg K251905 - Normatec Elite Hip K251905 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: NormaTec Industries, LP. Cleared Sep 2025. https://www.510kdatabase.net/k252428/ 2025-09-18 monthly 0.8 https://www.510kdatabase.net/og-image/k252428-electric-wheelchair-model-p2-fda-510k.jpg K252428 - Electric Wheelchair (Model P2) K252428 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Superpi Robot Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k243752/ 2025-09-17 monthly 0.8 https://www.510kdatabase.net/og-image/k243752-double-tube-herbst-appliance-fda-510k.jpg K243752 - Double Tube Herbst Appliance K243752 is a FDA 510(k) cleared dental medical device. Manufacturer: The Tmj Clinic PC. Cleared Sep 2025. https://www.510kdatabase.net/k244006/ 2025-09-17 monthly 0.8 https://www.510kdatabase.net/og-image/k244006-fg-bone-graft-m-fda-510k.jpg K244006 - FG Bone Graft M K244006 is a FDA 510(k) cleared dental medical device. Manufacturer: Full Golden Biotech Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k251095/ 2025-09-17 monthly 0.8 https://www.510kdatabase.net/og-image/k251095-pegavision-hioxifilcon-a-daily-fda-510k.jpg K251095 - Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses K251095 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Pegavision Corporation. Cleared Sep 2025. https://www.510kdatabase.net/k251221/ 2025-09-17 monthly 0.8 https://www.510kdatabase.net/og-image/k251221-assert-iq-dm5000-fda-510k.jpg K251221 - Assert-IQ (DM5000) K251221 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott. Cleared Sep 2025. https://www.510kdatabase.net/k251386/ 2025-09-17 monthly 0.8 https://www.510kdatabase.net/og-image/k251386-echelon-synergy-fda-510k.jpg K251386 - ECHELON Synergy K251386 is a FDA 510(k) cleared radiology medical device. Manufacturer: Fujifilm Corporation. Cleared Sep 2025. https://www.510kdatabase.net/k251446/ 2025-09-17 monthly 0.8 https://www.510kdatabase.net/og-image/k251446-plasmaflow-x-compression-sleeve-device-fda-510k.jpg K251446 - PlasmaFlow X Compression Sleeve Device (XPF0001) K251446 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Manamed, LLC. Cleared Sep 2025. https://www.510kdatabase.net/k251623/ 2025-09-17 monthly 0.8 https://www.510kdatabase.net/og-image/k251623-air-compression-therapy-device-fda-510k.jpg K251623 - Air Compression Therapy Device (K1002/K1006/K1007/K1008/K1061) K251623 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Shenzhen Yicai Health Technology Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k251688/ 2025-09-17 monthly 0.8 https://www.510kdatabase.net/og-image/k251688-carpentier-edwards-physio-annuloplasty-fda-510k.jpg K251688 - Carpentier-Edwards Physio Annuloplasty Ring (4450) K251688 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Sep 2025. https://www.510kdatabase.net/k251902/ 2025-09-17 monthly 0.8 https://www.510kdatabase.net/og-image/k251902-vitaform-procedural-mask-blue-vitaform-fda-510k.jpg K251902 - Vitaform Procedural Mask - Blue (Vitaform Blue) K251902 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Vitacore Industries, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k252035/ 2025-09-17 monthly 0.8 https://www.510kdatabase.net/og-image/k252035-denture-soft-ex-pink-set-fda-510k.jpg K252035 - DENTURE SOFT EX (Pink set) K252035 is a FDA 510(k) cleared dental medical device. Manufacturer: Kamemizu Chemical Industry Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k252615/ 2025-09-17 monthly 0.8 https://www.510kdatabase.net/og-image/k252615-ruthless-spine-rjb-fda-510k.jpg K252615 - Ruthless Spine RJB K252615 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ruthless, LLC Dba Ruthless Spine. Cleared Sep 2025. https://www.510kdatabase.net/k242287/ 2025-09-16 monthly 0.8 https://www.510kdatabase.net/og-image/k242287-sfit-abutment-fda-510k.jpg K242287 - SFIT Abutment K242287 is a FDA 510(k) cleared dental medical device. Manufacturer: Cowellmedi Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k251650/ 2025-09-16 monthly 0.8 https://www.510kdatabase.net/og-image/k251650-insight-enhanced-drf-en-1002-01-fda-510k.jpg K251650 - Insight Enhanced™ DRF (EN-1002-01) K251650 is a FDA 510(k) cleared radiology medical device. Manufacturer: Imaging Engineering, LLC. Cleared Sep 2025. https://www.510kdatabase.net/k251676/ 2025-09-16 monthly 0.8 https://www.510kdatabase.net/og-image/k251676-medline-microtek-c-flo-bag-decanter-fda-510k.jpg K251676 - Medline Microtek C-Flo Bag Decanter, Sterile (2000S) K251676 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Microtek Medical, LLC. Cleared Sep 2025. https://www.510kdatabase.net/k252540/ 2025-09-16 monthly 0.8 https://www.510kdatabase.net/og-image/k252540-accuject-injector-set-21-1p-lp604590-fda-510k.jpg K252540 - ACCUJECT Injector Set 2.1-1P (LP604590) K252540 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Medicel AG. Cleared Sep 2025. https://www.510kdatabase.net/k250237/ 2025-09-15 monthly 0.8 https://www.510kdatabase.net/og-image/k250237-inferoperate-suite-fda-510k.jpg K250237 - InferOperate Suite K250237 is a FDA 510(k) cleared radiology medical device. Manufacturer: Beijing Infervision Healthcare Medical Technology Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k250609/ 2025-09-15 monthly 0.8 https://www.510kdatabase.net/og-image/k250609-sober-self-test-fda-510k.jpg K250609 - Sober Self-Test K250609 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Sober Ip, LLC. Cleared Sep 2025. https://www.510kdatabase.net/k251780/ 2025-09-15 monthly 0.8 https://www.510kdatabase.net/og-image/k251780-igps-navigation-instruments-fda-510k.jpg K251780 - iGPS Navigation Instruments K251780 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SI-BONE, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k251869/ 2025-09-15 monthly 0.8 https://www.510kdatabase.net/og-image/k251869-disposable-prophy-angle-3399-60-3399-fda-510k.jpg K251869 - Disposable Prophy Angle (3399-60, 3399-090, 3399-105) K251869 is a FDA 510(k) cleared dental medical device. Manufacturer: Premium Plus (Dongguan) Limited. Cleared Sep 2025. https://www.510kdatabase.net/k251914/ 2025-09-15 monthly 0.8 https://www.510kdatabase.net/og-image/k251914-ipl-hair-removal-device-mly-m011-fda-510k.jpg K251914 - IPL Hair Removal Device (MLY-M011) K251914 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Miley Technology (Hebei) Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k252128/ 2025-09-15 monthly 0.8 https://www.510kdatabase.net/og-image/k252128-zener-model-zen-001-b1-fda-510k.jpg K252128 - Zener® (model ZEN-001-B1) K252128 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Uvx, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k252443/ 2025-09-15 monthly 0.8 https://www.510kdatabase.net/og-image/k252443-spacefix-shoulder-spacer-fda-510k.jpg K252443 - SpaceFix Shoulder Spacer K252443 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: G21, S.R.L.. Cleared Sep 2025. https://www.510kdatabase.net/k252598/ 2025-09-15 monthly 0.8 https://www.510kdatabase.net/og-image/k252598-flexible-cystoscope-cy50h-20eu-cy50h-fda-510k.jpg K252598 - Flexible Cystoscope (CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) K252598 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Shanghai AnQing Medical Instrument Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k250689/ 2025-09-14 monthly 0.8 https://www.510kdatabase.net/og-image/k250689-cloudtms-edge-fda-510k.jpg K250689 - CloudTMS Edge K250689 is a FDA 510(k) cleared neurology medical device. Manufacturer: Teleemg, LLC. Cleared Sep 2025. https://www.510kdatabase.net/k251449/ 2025-09-13 monthly 0.8 https://www.510kdatabase.net/og-image/k251449-brainsway-deep-tms-system-fda-510k.jpg K251449 - BrainsWay Deep TMS System K251449 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainsway , Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k243864/ 2025-09-12 monthly 0.8 https://www.510kdatabase.net/og-image/k243864-bonx805-fda-510k.jpg K243864 - BONX805 K243864 is a FDA 510(k) cleared radiology medical device. Manufacturer: Bontech Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k250040/ 2025-09-12 monthly 0.8 https://www.510kdatabase.net/og-image/k250040-uws-angio-fda-510k.jpg K250040 - uWS-Angio K250040 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k250047/ 2025-09-12 monthly 0.8 https://www.510kdatabase.net/og-image/k250047-bite-away-two-fda-510k.jpg K250047 - bite away two K250047 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: mibeTec GmbH. Cleared Sep 2025. https://www.510kdatabase.net/k250059/ 2025-09-12 monthly 0.8 https://www.510kdatabase.net/og-image/k250059-bd-phaseal-optima-connecting-set-c83-o-fda-510k.jpg K250059 - BD PhaSeal™ Optima Connecting Set (C83-O) K250059 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson and Company. Cleared Sep 2025. https://www.510kdatabase.net/k250445/ 2025-09-12 monthly 0.8 https://www.510kdatabase.net/og-image/k250445-fast-warm-nx-fda-510k.jpg K250445 - Fast Warm - NX K250445 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Fujifilm Irvine Scientific. Cleared Sep 2025. https://www.510kdatabase.net/k250628/ 2025-09-12 monthly 0.8 https://www.510kdatabase.net/og-image/k250628-dynanail-ttc-fusion-system-fda-510k.jpg K250628 - DynaNail TTC Fusion System K250628 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: MedShape, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k250986/ 2025-09-12 monthly 0.8 https://www.510kdatabase.net/og-image/k250986-s250-fit-proton-beam-radiation-therapy-fda-510k.jpg K250986 - S250-FIT Proton Beam Radiation Therapy Device (S250-FIT) K250986 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mevion Medical Systems, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k251083/ 2025-09-12 monthly 0.8 https://www.510kdatabase.net/og-image/k251083-compact-ii-fda-510k.jpg K251083 - Compact II K251083 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Enraf-Nonius, B.V.. Cleared Sep 2025. https://www.510kdatabase.net/k251170/ 2025-09-12 monthly 0.8 https://www.510kdatabase.net/og-image/k251170-tangent-single-use-digital-system-fda-510k.jpg K251170 - Tangent Single-Use Digital System: Tangent Single-Use Digital Catheter and Tangent Digital Controller K251170 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Tangent Endoscopy, LLC. Cleared Sep 2025. https://www.510kdatabase.net/k251368/ 2025-09-12 monthly 0.8 https://www.510kdatabase.net/og-image/k251368-fetoly-fda-510k.jpg K251368 - FETOLY K251368 is a FDA 510(k) cleared radiology medical device. Manufacturer: Diagnoly. Cleared Sep 2025. https://www.510kdatabase.net/k251518/ 2025-09-12 monthly 0.8 https://www.510kdatabase.net/og-image/k251518-volta-af-xplorer-ii-fda-510k.jpg K251518 - Volta AF-Xplorer II K251518 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Volta Medical. Cleared Sep 2025. https://www.510kdatabase.net/k251820/ 2025-09-12 monthly 0.8 https://www.510kdatabase.net/og-image/k251820-viewmatetm-ultrasound-system-fda-510k.jpg K251820 - ViewMateTM Ultrasound System K251820 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k251843/ 2025-09-12 monthly 0.8 https://www.510kdatabase.net/og-image/k251843-erchonia-evrl-fda-510k.jpg K251843 - Erchonia EVRL K251843 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Erchonia Corporation. Cleared Sep 2025. https://www.510kdatabase.net/k252027/ 2025-09-12 monthly 0.8 https://www.510kdatabase.net/og-image/k252027-vertextm-catheter-fda-510k.jpg K252027 - Vertex(TM) Catheter K252027 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Jupiter Endovascular. Cleared Sep 2025. https://www.510kdatabase.net/k252189/ 2025-09-12 monthly 0.8 https://www.510kdatabase.net/og-image/k252189-led-light-therapy-mask-2311-2344-2457-fda-510k.jpg K252189 - LED Light Therapy Mask (2311, 2344, 2457, 2458) K252189 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Dongguan Yanxi Technology Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k252225/ 2025-09-12 monthly 0.8 https://www.510kdatabase.net/og-image/k252225-powerknot-high-strength-sutures-fda-510k.jpg K252225 - PowerKnot High Strength Sutures K252225 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medacta International S.A.. Cleared Sep 2025. https://www.510kdatabase.net/k252554/ 2025-09-12 monthly 0.8 https://www.510kdatabase.net/og-image/k252554-wisdiag-multi-drug-urine-test-cup-fda-510k.jpg K252554 - Wisdiag Multi-Drug Urine Test Cup K252554 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Vivachek Biotech (Hangzhou) Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k252562/ 2025-09-12 monthly 0.8 https://www.510kdatabase.net/og-image/k252562-spine-trauma-navigation-instruments-fda-510k.jpg K252562 - Spine & Trauma Navigation Instruments K252562 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Brainlab AG. Cleared Sep 2025. https://www.510kdatabase.net/k252576/ 2025-09-12 monthly 0.8 https://www.510kdatabase.net/og-image/k252576-legend-x-platform-fda-510k.jpg K252576 - Legend X Platform K252576 is a FDA 510(k) cleared neurology medical device. Manufacturer: Pollogen, Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k252586/ 2025-09-12 monthly 0.8 https://www.510kdatabase.net/og-image/k252586-caddie-fda-510k.jpg K252586 - CADDIE K252586 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Odin Medical Limited. Cleared Sep 2025. https://www.510kdatabase.net/k252593/ 2025-09-12 monthly 0.8 https://www.510kdatabase.net/og-image/k252593-lux-dx-ii-insertable-cardiac-monitor-fda-510k.jpg K252593 - LUX-Dx II Insertable Cardiac Monitor (M302) K252593 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Sep 2025. https://www.510kdatabase.net/k252595/ 2025-09-12 monthly 0.8 https://www.510kdatabase.net/og-image/k252595-stethophone-pro-fda-510k.jpg K252595 - Stethophone Pro K252595 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sparrow Acoustics, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k242314/ 2025-09-11 monthly 0.8 https://www.510kdatabase.net/og-image/k242314-minimally-invasive-prostate-surgery-fda-510k.jpg K242314 - Minimally Invasive Prostate Surgery Navigation System(Model:AmaKris SR1-A-2) K242314 is a FDA 510(k) cleared radiology medical device. Manufacturer: Augment Intelligent Medical System (China) Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k243926/ 2025-09-11 monthly 0.8 https://www.510kdatabase.net/og-image/k243926-vivatmo-pro-s-fda-510k.jpg K243926 - Vivatmo pro-S K243926 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bosch Healthcare Solutions GmbH. Cleared Sep 2025. https://www.510kdatabase.net/k250216/ 2025-09-11 monthly 0.8 https://www.510kdatabase.net/og-image/k250216-osteoprobe-op-100-fda-510k.jpg K250216 - OsteoProbe (OP-100) K250216 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Active Life Scientific, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k250507/ 2025-09-11 monthly 0.8 https://www.510kdatabase.net/og-image/k250507-hypertension-notification-feature-htnf-fda-510k.jpg K250507 - Hypertension Notification Feature (HTNF) K250507 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Apple, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k250797/ 2025-09-11 monthly 0.8 https://www.510kdatabase.net/og-image/k250797-uv5000-handle-fda-510k.jpg K250797 - UV5000 Handle K250797 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Uroviu Corporation. Cleared Sep 2025. https://www.510kdatabase.net/k251158/ 2025-09-11 monthly 0.8 https://www.510kdatabase.net/og-image/k251158-powerwire-14-radiofrequency-guidewire-fda-510k.jpg K251158 - PowerWire® 14 Radiofrequency Guidewire Kit K251158 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baylis Medical Technologies, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k251316/ 2025-09-11 monthly 0.8 https://www.510kdatabase.net/og-image/k251316-mazor-x-system-mazor-x-stealth-edition-fda-510k.jpg K251316 - Mazor X System / Mazor X Stealth Edition K251316 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Mazor Robotics , Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k251320/ 2025-09-11 monthly 0.8 https://www.510kdatabase.net/og-image/k251320-xtra4-fda-510k.jpg K251320 - XTRA4 K251320 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Al.Chi.Mi.A. S.R.L. Cleared Sep 2025. https://www.510kdatabase.net/k251399/ 2025-09-11 monthly 0.8 https://www.510kdatabase.net/og-image/k251399-signa-sprint-fda-510k.jpg K251399 - SIGNA™ Sprint K251399 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems, LLC. Cleared Sep 2025. https://www.510kdatabase.net/k251758/ 2025-09-11 monthly 0.8 https://www.510kdatabase.net/og-image/k251758-serafin-fda-510k.jpg K251758 - Serafin® K251758 is a FDA 510(k) cleared dental medical device. Manufacturer: Tns Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k251826/ 2025-09-11 monthly 0.8 https://www.510kdatabase.net/og-image/k251826-renasys-wound-dressing-kit-with-fda-510k.jpg K251826 - RENASYS WOUND+ Dressing Kit with AIRLOCK Technology K251826 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew Medical, Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k252374/ 2025-09-11 monthly 0.8 https://www.510kdatabase.net/og-image/k252374-nylon-flextapr-fda-510k.jpg K252374 - Nylon flexTAP(R) K252374 is a FDA 510(k) cleared dental medical device. Manufacturer: Airway Technologies D/B/A Airway Management. Cleared Sep 2025. https://www.510kdatabase.net/k252520/ 2025-09-11 monthly 0.8 https://www.510kdatabase.net/og-image/k252520-sefria-hydrocodone-oral-fluid-fda-510k.jpg K252520 - SEFRIA™ Hydrocodone Oral Fluid K252520 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Immunalysis Corporation. Cleared Sep 2025. https://www.510kdatabase.net/k244002/ 2025-09-10 monthly 0.8 https://www.510kdatabase.net/og-image/k244002-angiowavenet-fda-510k.jpg K244002 - AngioWaveNet K244002 is a FDA 510(k) cleared radiology medical device. Manufacturer: Angiowave Imaging, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k250464/ 2025-09-10 monthly 0.8 https://www.510kdatabase.net/og-image/k250464-enlight-2100-tpl-e2103-0-fda-510k.jpg K250464 - Enlight 2100 (TPL-E2103-0) K250464 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Timpel S.A.. Cleared Sep 2025. https://www.510kdatabase.net/k250734/ 2025-09-10 monthly 0.8 https://www.510kdatabase.net/og-image/k250734-optiluv-device-fda-510k.jpg K250734 - OptiLUV Device K250734 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Pollogen, Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k251573/ 2025-09-10 monthly 0.8 https://www.510kdatabase.net/og-image/k251573-vizionfocus-somofilcon-a-silicone-fda-510k.jpg K251573 - VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens K251573 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Vizionfocus, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k251817/ 2025-09-10 monthly 0.8 https://www.510kdatabase.net/og-image/k251817-da-vinci-sp-surgical-system-sp1098-fda-510k.jpg K251817 - da Vinci SP Surgical System (SP1098) K251817 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k252173/ 2025-09-10 monthly 0.8 https://www.510kdatabase.net/og-image/k252173-fp-optiniv-hospital-vented-full-face-fda-510k.jpg K252173 - F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits – Size A (ONIV117A) K252173 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Fisher &Paykel Healthcare , Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k252527/ 2025-09-10 monthly 0.8 https://www.510kdatabase.net/og-image/k252527-surfacer-inside-out-access-catheter-fda-510k.jpg K252527 - Surfacer Inside-Out Access Catheter System K252527 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical System, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k252530/ 2025-09-10 monthly 0.8 https://www.510kdatabase.net/og-image/k252530-optivu-shoulder-fda-510k.jpg K252530 - OptiVu™ Shoulder K252530 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Mr Surgical Solutions, LLC. Cleared Sep 2025. https://www.510kdatabase.net/k252580/ 2025-09-10 monthly 0.8 https://www.510kdatabase.net/og-image/k252580-iq200-series-fda-510k.jpg K252580 - iQ200 Series K252580 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k243846/ 2025-09-09 monthly 0.8 https://www.510kdatabase.net/og-image/k243846-access-anti-hav-fda-510k.jpg K243846 - Access anti-HAV K243846 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k250483/ 2025-09-09 monthly 0.8 https://www.510kdatabase.net/og-image/k250483-photonblade-3-fda-510k.jpg K250483 - PhotonBlade 3 K250483 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Stryker Instruments. Cleared Sep 2025. https://www.510kdatabase.net/k250922/ 2025-09-09 monthly 0.8 https://www.510kdatabase.net/og-image/k250922-edema-guard-monitor-egm-cardioset-001-fda-510k.jpg K250922 - Edema Guard Monitor (EGM) CardioSet-001 K250922 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cardioset Medical , Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k251040/ 2025-09-09 monthly 0.8 https://www.510kdatabase.net/og-image/k251040-misslan-early-detection-digital-fda-510k.jpg K251040 - MissLan® Early Detection Digital Pregnancy Test K251040 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Guangzhou Decheng Biotechnology Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k251072/ 2025-09-09 monthly 0.8 https://www.510kdatabase.net/og-image/k251072-segmentron-viewer-fda-510k.jpg K251072 - Segmentron Viewer K251072 is a FDA 510(k) cleared radiology medical device. Manufacturer: DGNCT, LLC. Cleared Sep 2025. https://www.510kdatabase.net/k251682/ 2025-09-09 monthly 0.8 https://www.510kdatabase.net/og-image/k251682-muscleview-20-fda-510k.jpg K251682 - MuscleView 2.0 K251682 is a FDA 510(k) cleared radiology medical device. Manufacturer: Springbok, Inc. (Dba Springbok Analytics). Cleared Sep 2025. https://www.510kdatabase.net/k251773/ 2025-09-09 monthly 0.8 https://www.510kdatabase.net/og-image/k251773-water-soluble-personal-lubricant-satin-fda-510k.jpg K251773 - Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant K251773 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shenzhen Yongquan Medical Devices Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k251891/ 2025-09-09 monthly 0.8 https://www.510kdatabase.net/og-image/k251891-electric-wheelchair-gy-e001-fda-510k.jpg K251891 - Electric Wheelchair (GY-E001) K251891 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Shandong Guyue Healthcare Appliance Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k252180/ 2025-09-09 monthly 0.8 https://www.510kdatabase.net/og-image/k252180-bicarby-dialysate-rfp-404-rfp-404-w-fda-510k.jpg K252180 - Bicarby Dialysate RFP-404 (RFP-404-W) K252180 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC. Cleared Sep 2025. https://www.510kdatabase.net/k252181/ 2025-09-09 monthly 0.8 https://www.510kdatabase.net/og-image/k252181-aquaa-fda-510k.jpg K252181 - AquaA K252181 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fresenius Medical Care North America. Cleared Sep 2025. https://www.510kdatabase.net/k252477/ 2025-09-09 monthly 0.8 https://www.510kdatabase.net/og-image/k252477-hybrid-viewer-00859873006240-fda-510k.jpg K252477 - Hybrid Viewer (00859873006240) K252477 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hermes Medical Solutions AB. Cleared Sep 2025. https://www.510kdatabase.net/k252524/ 2025-09-09 monthly 0.8 https://www.510kdatabase.net/og-image/k252524-quadsense-quadsense-and-quadsense-pro-fda-510k.jpg K252524 - Quadsense (Quadsense and Quadsense Pro) K252524 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Eventum Orthopaedics, Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k252608/ 2025-09-09 monthly 0.8 https://www.510kdatabase.net/og-image/k252608-ai-rad-companion-prostate-mr-fda-510k.jpg K252608 - AI-Rad Companion Prostate MR K252608 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Healthcare GmbH. Cleared Sep 2025. https://www.510kdatabase.net/k250229/ 2025-09-08 monthly 0.8 https://www.510kdatabase.net/og-image/k250229-dual-action-tissue-closure-device-fda-510k.jpg K250229 - Dual Action Tissue Closure Device K250229 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Micro-Tech (Nanjing) Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k250928/ 2025-09-08 monthly 0.8 https://www.510kdatabase.net/og-image/k250928-omnitom-elite-with-pcd-fda-510k.jpg K250928 - OmniTom Elite with PCD K250928 is a FDA 510(k) cleared radiology medical device. Manufacturer: Neurologica Corporation. Cleared Sep 2025. https://www.510kdatabase.net/k250960/ 2025-09-08 monthly 0.8 https://www.510kdatabase.net/og-image/k250960-duo-microcatheter-fda-510k.jpg K250960 - DUO Microcatheter K250960 is a FDA 510(k) cleared neurology medical device. Manufacturer: Rev Neuro, LLC. Cleared Sep 2025. https://www.510kdatabase.net/k251227/ 2025-09-08 monthly 0.8 https://www.510kdatabase.net/og-image/k251227-da-vinci-surgical-system-is5000-fda-510k.jpg K251227 - da Vinci Surgical System (IS5000) K251227 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k251394/ 2025-09-08 monthly 0.8 https://www.510kdatabase.net/og-image/k251394-momcozy-wearable-breast-pump-bp223-fda-510k.jpg K251394 - Momcozy Wearable Breast Pump (BP223) K251394 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shenzhen Root Innovation Technology Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k251610/ 2025-09-08 monthly 0.8 https://www.510kdatabase.net/og-image/k251610-qer-cta-v10-fda-510k.jpg K251610 - qER-CTA (v1.0) K251610 is a FDA 510(k) cleared radiology medical device. Manufacturer: Qure.Ai Technologies. Cleared Sep 2025. https://www.510kdatabase.net/k251754/ 2025-09-08 monthly 0.8 https://www.510kdatabase.net/og-image/k251754-wearable-breast-pump-model-s33-fda-510k.jpg K251754 - Wearable Breast Pump (Model S33) K251754 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shenzhen TPH Technology Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k251892/ 2025-09-08 monthly 0.8 https://www.510kdatabase.net/og-image/k251892-maxxos-pace-foot-ankle-plating-system-fda-510k.jpg K251892 - MAXXOS P.A.C.E. Foot & Ankle Plating System K251892 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Maxxos Medical GmbH. Cleared Sep 2025. https://www.510kdatabase.net/k251931/ 2025-09-08 monthly 0.8 https://www.510kdatabase.net/og-image/k251931-biotraceio-vision-v17-fda-510k.jpg K251931 - BioTraceIO Vision (V1.7) K251931 is a FDA 510(k) cleared radiology medical device. Manufacturer: Techsomed Medical Technologies. Cleared Sep 2025. https://www.510kdatabase.net/k251957/ 2025-09-08 monthly 0.8 https://www.510kdatabase.net/og-image/k251957-coaptium-connect-with-tissium-light-fda-510k.jpg K251957 - Coaptium Connect with Tissium Light K251957 is a FDA 510(k) cleared neurology medical device. Manufacturer: Tissium SA. Cleared Sep 2025. https://www.510kdatabase.net/k243795/ 2025-09-05 monthly 0.8 https://www.510kdatabase.net/og-image/k243795-preboa-pro-catheter-fda-510k.jpg K243795 - pREBOA-PRO Catheter K243795 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Prytime Medical Devices, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k244038/ 2025-09-05 monthly 0.8 https://www.510kdatabase.net/og-image/k244038-high-pressure-tubing-fda-510k.jpg K244038 - High Pressure Tubing K244038 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shandong Int Medical Instruments Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k250095/ 2025-09-05 monthly 0.8 https://www.510kdatabase.net/og-image/k250095-all-suture-dual-anchor-system-fda-510k.jpg K250095 - All-Suture Dual Anchor System K250095 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Suturetech, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k250132/ 2025-09-05 monthly 0.8 https://www.510kdatabase.net/og-image/k250132-ureteral-access-sheath-fda-510k.jpg K250132 - Ureteral Access Sheath K250132 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Zhejiang Yigao Medical Technology Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k250460/ 2025-09-05 monthly 0.8 https://www.510kdatabase.net/og-image/k250460-watchpat400-wp400-fda-510k.jpg K250460 - WatchPAT400 (WP400) K250460 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Itamar Medical , Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k250575/ 2025-09-05 monthly 0.8 https://www.510kdatabase.net/og-image/k250575-the-sensititre-18-24-hour-mic-or-fda-510k.jpg K250575 - The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with Aztreonam/avibactam in the dilution range of 0.008/4 - 64/4 ug/mL K250575 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Thermo Fisher Scientific. Cleared Sep 2025. https://www.510kdatabase.net/k251022/ 2025-09-05 monthly 0.8 https://www.510kdatabase.net/og-image/k251022-3d-shaper-fda-510k.jpg K251022 - 3D-SHAPER K251022 is a FDA 510(k) cleared radiology medical device. Manufacturer: 3D-Shaper Medical S.L. Cleared Sep 2025. https://www.510kdatabase.net/k251250/ 2025-09-05 monthly 0.8 https://www.510kdatabase.net/og-image/k251250-viewmate-multi-ultrasound-system-vmm-fda-510k.jpg K251250 - ViewMate™ Multi Ultrasound System (VMM-ICE-01) K251250 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k251317/ 2025-09-05 monthly 0.8 https://www.510kdatabase.net/og-image/k251317-solopass-20-system-fda-510k.jpg K251317 - SOLOPASS 2.0 System K251317 is a FDA 510(k) cleared neurology medical device. Manufacturer: Intravent Medical Partners. Cleared Sep 2025. https://www.510kdatabase.net/k251753/ 2025-09-05 monthly 0.8 https://www.510kdatabase.net/og-image/k251753-genacheck-covid-19-rapid-self-test-fda-510k.jpg K251753 - GenaCheck COVID-19 Rapid Self-Test K251753 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Genabio Diagnostics, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k252478/ 2025-09-05 monthly 0.8 https://www.510kdatabase.net/og-image/k252478-vaccess-ct-low-profile-power-fda-510k.jpg K252478 - Vaccess™ CT Low-Profile Power-Injectable Implantable Port K252478 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bard Access Systems, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k252528/ 2025-09-05 monthly 0.8 https://www.510kdatabase.net/og-image/k252528-ion-endoluminal-system-if1000-fda-510k.jpg K252528 - Ion Endoluminal System (IF1000) K252528 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k243700/ 2025-09-04 monthly 0.8 https://www.510kdatabase.net/og-image/k243700-apollo-tms-therapy-system-fda-510k.jpg K243700 - Apollo TMS Therapy System K243700 is a FDA 510(k) cleared neurology medical device. Manufacturer: Mag & More GmbH. Cleared Sep 2025. https://www.510kdatabase.net/k243789/ 2025-09-04 monthly 0.8 https://www.510kdatabase.net/og-image/k243789-liberty-endovascular-robotic-system-fda-510k.jpg K243789 - LIBERTY Endovascular Robotic System (LIBERTYOS) K243789 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Microbot Medical , Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k250064/ 2025-09-04 monthly 0.8 https://www.510kdatabase.net/og-image/k250064-dose-10-fda-510k.jpg K250064 - Dose+ (1.0) K250064 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mvision AI OY. Cleared Sep 2025. https://www.510kdatabase.net/k250353/ 2025-09-04 monthly 0.8 https://www.510kdatabase.net/og-image/k250353-oniris-fda-510k.jpg K250353 - Oniris K250353 is a FDA 510(k) cleared dental medical device. Manufacturer: Oniris. Cleared Sep 2025. https://www.510kdatabase.net/k250770/ 2025-09-04 monthly 0.8 https://www.510kdatabase.net/og-image/k250770-optina-4c-mhrc-c1n-fda-510k.jpg K250770 - Optina-4C (MHRC-C1N) K250770 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Optina Diagnostics, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k250893/ 2025-09-04 monthly 0.8 https://www.510kdatabase.net/og-image/k250893-ball-joint-guide-array-66295-fda-510k.jpg K250893 - Ball Joint Guide Array (66295) K250893 is a FDA 510(k) cleared neurology medical device. Manufacturer: Bayer Medical Care, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k251168/ 2025-09-04 monthly 0.8 https://www.510kdatabase.net/og-image/k251168-image-suite-fda-510k.jpg K251168 - Image Suite K251168 is a FDA 510(k) cleared radiology medical device. Manufacturer: Carestream Health, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k251298/ 2025-09-04 monthly 0.8 https://www.510kdatabase.net/og-image/k251298-mobile-laser-unit-1001-n2-fda-510k.jpg K251298 - Mobile Laser Unit (1001-N2) K251298 is a FDA 510(k) cleared neurology medical device. Manufacturer: Clinical Laserthermia Systems, AB. Cleared Sep 2025. https://www.510kdatabase.net/k251438/ 2025-09-04 monthly 0.8 https://www.510kdatabase.net/og-image/k251438-dental-x-ray-device-ai-ray-lite-ai-ray-fda-510k.jpg K251438 - Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) K251438 is a FDA 510(k) cleared radiology medical device. Manufacturer: Guilin Woodpecker Medical Instrument Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k251444/ 2025-09-04 monthly 0.8 https://www.510kdatabase.net/og-image/k251444-endoskeleton-interbody-systems-fda-510k.jpg K251444 - Endoskeleton™ Interbody Systems K251444 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k251463/ 2025-09-04 monthly 0.8 https://www.510kdatabase.net/og-image/k251463-ensite-x-ep-system-automark-index-fda-510k.jpg K251463 - EnSite™ X EP System, AutoMark Index Software License (ENSITE-AMI-01) K251463 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared Sep 2025. https://www.510kdatabase.net/k251510/ 2025-09-04 monthly 0.8 https://www.510kdatabase.net/og-image/k251510-symani-surgical-system-fda-510k.jpg K251510 - Symani Surgical System K251510 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medical Microinstruments, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k251533/ 2025-09-04 monthly 0.8 https://www.510kdatabase.net/og-image/k251533-rapid-obstructive-hydrocephalus-rapid-oh-fda-510k.jpg K251533 - Rapid Obstructive Hydrocephalus, Rapid OH K251533 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ischemaview, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k251545/ 2025-09-04 monthly 0.8 https://www.510kdatabase.net/og-image/k251545-intense-pulsed-light-therapy-device-fda-510k.jpg K251545 - Intense Pulsed Light Therapy Device (MMABM-1) K251545 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Micowey Medical Equipment (Guangxi) Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k251656/ 2025-09-04 monthly 0.8 https://www.510kdatabase.net/og-image/k251656-careverse-coronarydoc-careverse-fda-510k.jpg K251656 - Careverse CoronaryDoc (Careverse CoronaryDoc) K251656 is a FDA 510(k) cleared radiology medical device. Manufacturer: Careverse Technology Pte. , Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k251733/ 2025-09-04 monthly 0.8 https://www.510kdatabase.net/og-image/k251733-fluido-airguard-system-fda-510k.jpg K251733 - Fluido® AirGuard System K251733 is a FDA 510(k) cleared general hospital medical device. Manufacturer: The Surgical Company International BV (As Tsc Life). Cleared Sep 2025. https://www.510kdatabase.net/k251737/ 2025-09-04 monthly 0.8 https://www.510kdatabase.net/og-image/k251737-nextartm-shoulder-platform-fda-510k.jpg K251737 - NextAR(TM) Shoulder Platform K251737 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Sep 2025. https://www.510kdatabase.net/k251781/ 2025-09-04 monthly 0.8 https://www.510kdatabase.net/og-image/k251781-kala-mini-20-kala-04-fda-510k.jpg K251781 - KALA MINI 2.0 (KALA-04) K251781 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Kaiyan Medical Equipment Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k231952/ 2025-09-03 monthly 0.8 https://www.510kdatabase.net/og-image/k231952-medilight-fda-510k.jpg K231952 - MEDILIGHT K231952 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medicreations, LLC. Cleared Sep 2025. https://www.510kdatabase.net/k250217/ 2025-09-03 monthly 0.8 https://www.510kdatabase.net/og-image/k250217-agnes-ultra-fda-510k.jpg K250217 - AGNES Ultra K250217 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Agnes Medical Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k250231/ 2025-09-03 monthly 0.8 https://www.510kdatabase.net/og-image/k250231-automatic-upper-arm-blood-pressure-fda-510k.jpg K250231 - Automatic Upper Arm Blood Pressure Monitor (BA-831X, BA-832X, BA-833X, BA-837X, BA-838X, BA-842X, BA-843X, BA-845X, BA-847X, BA-849X, BA-851X, BA-852X, BA-855X, BA-835, BA-836, BA-839, BA-840, BA-856) K250231 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Dongguan E-Test Technology Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k250765/ 2025-09-03 monthly 0.8 https://www.510kdatabase.net/og-image/k250765-avita-arm-type-blood-pressure-monitor-fda-510k.jpg K250765 - AViTA Arm Type Blood Pressure Monitor Cuff K250765 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Avita Corporation. Cleared Sep 2025. https://www.510kdatabase.net/k251457/ 2025-09-03 monthly 0.8 https://www.510kdatabase.net/og-image/k251457-diode-laser-therapy-device-vader-fda-510k.jpg K251457 - Diode laser therapy device (VADER) K251457 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Beijing Superlaser Technology Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k251575/ 2025-09-03 monthly 0.8 https://www.510kdatabase.net/og-image/k251575-identiti-ii-alif-standalone-interbody-fda-510k.jpg K251575 - IdentiTi™ II ALIF Standalone Interbody System K251575 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine. Cleared Sep 2025. https://www.510kdatabase.net/k251726/ 2025-09-03 monthly 0.8 https://www.510kdatabase.net/og-image/k251726-signalned-system-model-re-fda-510k.jpg K251726 - SignalNED System (Model RE) K251726 is a FDA 510(k) cleared neurology medical device. Manufacturer: Forest Devices, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k251909/ 2025-09-03 monthly 0.8 https://www.510kdatabase.net/og-image/k251909-neurotris-sx2500-fda-510k.jpg K251909 - NeurotriS (SX2500) K251909 is a FDA 510(k) cleared neurology medical device. Manufacturer: A-1 Engineering. Cleared Sep 2025. https://www.510kdatabase.net/k252174/ 2025-09-03 monthly 0.8 https://www.510kdatabase.net/og-image/k252174-aquacast-mask-fda-510k.jpg K252174 - AquaCast Mask K252174 is a FDA 510(k) cleared radiology medical device. Manufacturer: Blessing Cathay Corporation. Cleared Sep 2025. https://www.510kdatabase.net/k252446/ 2025-09-03 monthly 0.8 https://www.510kdatabase.net/og-image/k252446-bruxzir-now-fda-510k.jpg K252446 - BruxZir® NOW K252446 is a FDA 510(k) cleared dental medical device. Manufacturer: Prismatik Dentalcraft, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k252454/ 2025-09-03 monthly 0.8 https://www.510kdatabase.net/og-image/k252454-kinos-total-ankle-system-fda-510k.jpg K252454 - Kinos Total Ankle System K252454 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Restor3d. Cleared Sep 2025. https://www.510kdatabase.net/k252539/ 2025-09-03 monthly 0.8 https://www.510kdatabase.net/og-image/k252539-tempus-pixel-fda-510k.jpg K252539 - Tempus Pixel K252539 is a FDA 510(k) cleared radiology medical device. Manufacturer: Arterys, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k242768/ 2025-09-02 monthly 0.8 https://www.510kdatabase.net/og-image/k242768-customized-abutment-and-screw-fda-510k.jpg K242768 - Customized Abutment and Screw K242768 is a FDA 510(k) cleared dental medical device. Manufacturer: Chengdu Besmile Medical Technology Co., Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k250453/ 2025-09-02 monthly 0.8 https://www.510kdatabase.net/og-image/k250453-intellivue-patient-monitor-6100-6100-fda-510k.jpg K250453 - IntelliVue Patient Monitor 6100 (6100) K250453 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Philips Medizin Systeme B?blingen GmbH. Cleared Sep 2025. https://www.510kdatabase.net/k250753/ 2025-09-02 monthly 0.8 https://www.510kdatabase.net/og-image/k250753-velmeni-for-dentists-v4d-fda-510k.jpg K250753 - VELMENI for DENTISTS (V4D) K250753 is a FDA 510(k) cleared radiology medical device. Manufacturer: Velmeni, Inc.. Cleared Sep 2025. https://www.510kdatabase.net/k251408/ 2025-09-02 monthly 0.8 https://www.510kdatabase.net/og-image/k251408-osteosight-hip-v1-fda-510k.jpg K251408 - OsteoSight™ Hip (v1) K251408 is a FDA 510(k) cleared radiology medical device. Manufacturer: Naitive Technologies, Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k251615/ 2025-09-02 monthly 0.8 https://www.510kdatabase.net/og-image/k251615-aerogen-pro-x1-controller-system-fda-510k.jpg K251615 - Aerogen Pro-X1 Controller System K251615 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Aerogen, Ltd.. Cleared Sep 2025. https://www.510kdatabase.net/k251775/ 2025-09-02 monthly 0.8 https://www.510kdatabase.net/og-image/k251775-rodin-cement-fda-510k.jpg K251775 - RODIN Cement K251775 is a FDA 510(k) cleared dental medical device. Manufacturer: Belport Company, Inc., Gingi-Pak. Cleared Sep 2025. https://www.510kdatabase.net/k251975/ 2025-09-02 monthly 0.8 https://www.510kdatabase.net/og-image/k251975-achieve-partial-knee-system-porous-fda-510k.jpg K251975 - Achieve Partial Knee System - Porous Coated CoCrMo Femoral Component K251975 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ignite Orthomotion. Cleared Sep 2025. https://www.510kdatabase.net/k243745/ 2025-08-29 monthly 0.8 https://www.510kdatabase.net/og-image/k243745-fg-bone-graft-b-fda-510k.jpg K243745 - FG Bone Graft B K243745 is a FDA 510(k) cleared dental medical device. Manufacturer: Full Golden Biotech Corporation. Cleared Aug 2025. https://www.510kdatabase.net/k243799/ 2025-08-29 monthly 0.8 https://www.510kdatabase.net/og-image/k243799-fetal-pillow-fda-510k.jpg K243799 - Fetal Pillow K243799 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: CooperSurgical, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k243859/ 2025-08-29 monthly 0.8 https://www.510kdatabase.net/og-image/k243859-praevaorta2-fda-510k.jpg K243859 - PRAEVAorta®2 K243859 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nurea. Cleared Aug 2025. https://www.510kdatabase.net/k250003/ 2025-08-29 monthly 0.8 https://www.510kdatabase.net/og-image/k250003-geneseeqprime-ngs-tumor-profiling-fda-510k.jpg K250003 - GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) (GS6005) K250003 is a FDA 510(k) cleared pathology medical device. Manufacturer: Geneseeq Technology, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k250285/ 2025-08-29 monthly 0.8 https://www.510kdatabase.net/og-image/k250285-neurovent-p-092946-003-fda-510k.jpg K250285 - NEUROVENT-P (092946-003) K250285 is a FDA 510(k) cleared neurology medical device. Manufacturer: Raumedic AG. Cleared Aug 2025. https://www.510kdatabase.net/k250290/ 2025-08-29 monthly 0.8 https://www.510kdatabase.net/og-image/k250290-surgitwin-fda-510k.jpg K250290 - SurgiTwin K250290 is a FDA 510(k) cleared radiology medical device. Manufacturer: Twinsight. Cleared Aug 2025. https://www.510kdatabase.net/k250335/ 2025-08-29 monthly 0.8 https://www.510kdatabase.net/og-image/k250335-iva-aeon-cervical-and-lumbar-cage-system-fda-510k.jpg K250335 - IVA & AEON Cervical and Lumbar Cage System K250335 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: K&J Consulting. Cleared Aug 2025. https://www.510kdatabase.net/k250771/ 2025-08-29 monthly 0.8 https://www.510kdatabase.net/og-image/k250771-primescan-2-fda-510k.jpg K250771 - Primescan 2 K250771 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k250874/ 2025-08-29 monthly 0.8 https://www.510kdatabase.net/og-image/k250874-sunrise-fda-510k.jpg K250874 - Sunrise K250874 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sunrise SA. Cleared Aug 2025. https://www.510kdatabase.net/k250939/ 2025-08-29 monthly 0.8 https://www.510kdatabase.net/og-image/k250939-sirius-endoscope-system-pr-si-1230-fda-510k.jpg K250939 - SIRIUS Endoscope System (PR-SI-1230) K250939 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Precision Robotics (Hong Kong) Limited. Cleared Aug 2025. https://www.510kdatabase.net/k251026/ 2025-08-29 monthly 0.8 https://www.510kdatabase.net/og-image/k251026-regenesis-ems-chair-fda-510k.jpg K251026 - Regenesis EMS Chair K251026 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Trinity Medical Solutions. Cleared Aug 2025. https://www.510kdatabase.net/k251106/ 2025-08-29 monthly 0.8 https://www.510kdatabase.net/og-image/k251106-sonosite-lx-and-sonosite-px-ultrasound-fda-510k.jpg K251106 - Sonosite LX and Sonosite PX Ultrasound Systems K251106 is a FDA 510(k) cleared radiology medical device. Manufacturer: FUJIFILM Sonosite, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k251108/ 2025-08-29 monthly 0.8 https://www.510kdatabase.net/og-image/k251108-erbe-esu-model-vio-3n-with-accessories-fda-510k.jpg K251108 - Erbe ESU Model VIO® 3n with Accessories K251108 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Erbe Elektromedizin GmbH. Cleared Aug 2025. https://www.510kdatabase.net/k251181/ 2025-08-29 monthly 0.8 https://www.510kdatabase.net/og-image/k251181-splashwire-hydrophilic-guide-wire-fda-510k.jpg K251181 - Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5) K251181 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Ireland, Ltd.. Cleared Aug 2025. https://www.510kdatabase.net/k251217/ 2025-08-29 monthly 0.8 https://www.510kdatabase.net/og-image/k251217-smartguard-technology-fda-510k.jpg K251217 - SmartGuard technology K251217 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Medtronic Minimed, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k251324/ 2025-08-29 monthly 0.8 https://www.510kdatabase.net/og-image/k251324-da-vinci-sp-surgical-system-sp1098-fda-510k.jpg K251324 - da Vinci SP Surgical System (SP1098) K251324 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k251480/ 2025-08-29 monthly 0.8 https://www.510kdatabase.net/og-image/k251480-pv01-pvdf-effort-sensor-fda-510k.jpg K251480 - PV01 PVDF Effort Sensor K251480 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Neurotronics, LLC. Cleared Aug 2025. https://www.510kdatabase.net/k251718/ 2025-08-29 monthly 0.8 https://www.510kdatabase.net/og-image/k251718-artt-augments-and-buttresses-and-bone-fda-510k.jpg K251718 - ArTT Augments and Buttresses and Bone Screws K251718 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Lima Corporate S.P.A.. Cleared Aug 2025. https://www.510kdatabase.net/k251727/ 2025-08-29 monthly 0.8 https://www.510kdatabase.net/og-image/k251727-glam-led-facial-mask-tb-2386f-fda-510k.jpg K251727 - GLAM LED Facial Mask (TB-2386F) K251727 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.. Cleared Aug 2025. https://www.510kdatabase.net/k251814/ 2025-08-29 monthly 0.8 https://www.510kdatabase.net/og-image/k251814-ez-iv-administration-set-fda-510k.jpg K251814 - EZ™ IV Administration Set K251814 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Epic Medical Pte. , Ltd.. Cleared Aug 2025. https://www.510kdatabase.net/k251946/ 2025-08-29 monthly 0.8 https://www.510kdatabase.net/og-image/k251946-g-aenial-universal-injectable-ii-fda-510k.jpg K251946 - G aenial Universal Injectable II K251946 is a FDA 510(k) cleared dental medical device. Manufacturer: GC America, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k252019/ 2025-08-29 monthly 0.8 https://www.510kdatabase.net/og-image/k252019-curvafix-low-profile-system-fda-510k.jpg K252019 - CurvaFix Low Profile System K252019 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Curvafix, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k252364/ 2025-08-29 monthly 0.8 https://www.510kdatabase.net/og-image/k252364-edwards-esheath-optima-introducer-set-fda-510k.jpg K252364 - Edwards eSheath Optima introducer set K252364 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences. Cleared Aug 2025. https://www.510kdatabase.net/k252380/ 2025-08-29 monthly 0.8 https://www.510kdatabase.net/og-image/k252380-invisalign-system-fda-510k.jpg K252380 - Invisalign System K252380 is a FDA 510(k) cleared dental medical device. Manufacturer: Align Technology, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k252392/ 2025-08-29 monthly 0.8 https://www.510kdatabase.net/og-image/k252392-millipede70-aspiration-catheter-fda-510k.jpg K252392 - Millipede70 Aspiration Catheter K252392 is a FDA 510(k) cleared neurology medical device. Manufacturer: Perfuze, Ltd.. Cleared Aug 2025. https://www.510kdatabase.net/k243767/ 2025-08-28 monthly 0.8 https://www.510kdatabase.net/og-image/k243767-sv600-sv800-ventilator-fda-510k.jpg K243767 - SV600, SV800 Ventilator K243767 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Aug 2025. https://www.510kdatabase.net/k243901/ 2025-08-28 monthly 0.8 https://www.510kdatabase.net/og-image/k243901-smartpilot-ypsomate-ns-a225-fda-510k.jpg K243901 - SmartPilot YpsoMate NS-A2.25 K243901 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ypsomed AG. Cleared Aug 2025. https://www.510kdatabase.net/k250148/ 2025-08-28 monthly 0.8 https://www.510kdatabase.net/og-image/k250148-medical-gas-analyzer-ag200-fda-510k.jpg K250148 - Medical Gas Analyzer (AG200) K250148 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Prior Care Science Technology, Ltd.. Cleared Aug 2025. https://www.510kdatabase.net/k250788/ 2025-08-28 monthly 0.8 https://www.510kdatabase.net/og-image/k250788-definium-tempo-select-fda-510k.jpg K250788 - Definium Tempo Select K250788 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Hualun Medical Systems Co. , Ltd.. Cleared Aug 2025. https://www.510kdatabase.net/k251429/ 2025-08-28 monthly 0.8 https://www.510kdatabase.net/og-image/k251429-otc-4-channel-rechargeable-tens-unit-fda-510k.jpg K251429 - OTC 4-Channel Rechargeable TENS Unit K251429 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Changsha Anxiang Medical Technology Co., Ltd.. Cleared Aug 2025. https://www.510kdatabase.net/k251484/ 2025-08-28 monthly 0.8 https://www.510kdatabase.net/og-image/k251484-ctvq-fda-510k.jpg K251484 - CT:VQ K251484 is a FDA 510(k) cleared radiology medical device. Manufacturer: 4Dmedical Limited. Cleared Aug 2025. https://www.510kdatabase.net/k251594/ 2025-08-28 monthly 0.8 https://www.510kdatabase.net/og-image/k251594-truflex-fda-510k.jpg K251594 - truFlex K251594 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Syrma Johari Medtech Limited. Cleared Aug 2025. https://www.510kdatabase.net/k251965/ 2025-08-28 monthly 0.8 https://www.510kdatabase.net/og-image/k251965-proximity-anterior-cervical-plate-system-fda-510k.jpg K251965 - Proximity Anterior Cervical Plate System K251965 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k252014/ 2025-08-28 monthly 0.8 https://www.510kdatabase.net/og-image/k252014-the-sensititre-18-24-hour-mic-or-fda-510k.jpg K252014 - The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the dilution range of 0.25-256 ug/mL K252014 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Thermo Fisher Scientific. Cleared Aug 2025. https://www.510kdatabase.net/k252030/ 2025-08-28 monthly 0.8 https://www.510kdatabase.net/og-image/k252030-radiforce-gx570-fda-510k.jpg K252030 - RadiForce GX570 K252030 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eizo Corporation. Cleared Aug 2025. https://www.510kdatabase.net/k252057/ 2025-08-28 monthly 0.8 https://www.510kdatabase.net/og-image/k252057-symphony-thrombectomy-system-and-fda-510k.jpg K252057 - Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy System K252057 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Imperative Care, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k252350/ 2025-08-28 monthly 0.8 https://www.510kdatabase.net/og-image/k252350-da-vinci-sp-firefly-imaging-system-fda-510k.jpg K252350 - da Vinci SP Firefly Imaging System K252350 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k252383/ 2025-08-28 monthly 0.8 https://www.510kdatabase.net/og-image/k252383-somfit-d-fda-510k.jpg K252383 - Somfit D K252383 is a FDA 510(k) cleared neurology medical device. Manufacturer: Compumedics Limited. Cleared Aug 2025. https://www.510kdatabase.net/k252411/ 2025-08-28 monthly 0.8 https://www.510kdatabase.net/og-image/k252411-jarvis-glenoid-reverse-shoulder-fda-510k.jpg K252411 - JARVIS Glenoid Reverse Shoulder Prosthesis K252411 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: FH Industrie. Cleared Aug 2025. https://www.510kdatabase.net/k252437/ 2025-08-28 monthly 0.8 https://www.510kdatabase.net/og-image/k252437-jazz-spinal-system-fda-510k.jpg K252437 - JAZZ Spinal System K252437 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Implanet. Cleared Aug 2025. https://www.510kdatabase.net/k252505/ 2025-08-28 monthly 0.8 https://www.510kdatabase.net/og-image/k252505-powder-free-vinyl-exam-gloves-clear-fda-510k.jpg K252505 - Powder-Free Vinyl Exam Gloves, clear K252505 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Basic Medical Technology, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k241766/ 2025-08-27 monthly 0.8 https://www.510kdatabase.net/og-image/k241766-qmapp-hemo-hemo-lite-pcm-go-hybrid-fda-510k.jpg K241766 - QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid) K241766 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Fysicon BV. Cleared Aug 2025. https://www.510kdatabase.net/k241882/ 2025-08-27 monthly 0.8 https://www.510kdatabase.net/og-image/k241882-fetal-maternal-monitor-f15a-f15a-air-fda-510k.jpg K241882 - Fetal & Maternal Monitor (F15A, F15A Air) K241882 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Edan Instruments, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k243166/ 2025-08-27 monthly 0.8 https://www.510kdatabase.net/og-image/k243166-dermalage-fda-510k.jpg K243166 - Dermalage K243166 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Infection Elimination Solutions, LLC. Cleared Aug 2025. https://www.510kdatabase.net/k243687/ 2025-08-27 monthly 0.8 https://www.510kdatabase.net/og-image/k243687-vital-signs-fda-510k.jpg K243687 - Vital Signs K243687 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Oxehealth Limited. Cleared Aug 2025. https://www.510kdatabase.net/k243774/ 2025-08-27 monthly 0.8 https://www.510kdatabase.net/og-image/k243774-elid-endoscopic-less-invasive-fda-510k.jpg K243774 - ELID (Endoscopic Less Invasive Decompression) System K243774 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Lesspine Innovations. Cleared Aug 2025. https://www.510kdatabase.net/k250080/ 2025-08-27 monthly 0.8 https://www.510kdatabase.net/og-image/k250080-qiastat-dx-respiratory-panel-plus-fda-510k.jpg K250080 - QIAstat-Dx Respiratory Panel Plus K250080 is a FDA 510(k) cleared microbiology medical device. Manufacturer: QIAGEN GmbH. Cleared Aug 2025. https://www.510kdatabase.net/k250625/ 2025-08-27 monthly 0.8 https://www.510kdatabase.net/og-image/k250625-portable-oxygen-concentrator-w-r1max-fda-510k.jpg K250625 - Portable oxygen concentrator (W-R1(MAX)) K250625 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Nanjing Yinuoji Medical Technology Co., Ltd.. Cleared Aug 2025. https://www.510kdatabase.net/k250947/ 2025-08-27 monthly 0.8 https://www.510kdatabase.net/og-image/k250947-vistasoft-40-and-visionx-40-fda-510k.jpg K250947 - VistaSoft 4.0 and VisionX 4.0 K250947 is a FDA 510(k) cleared radiology medical device. Manufacturer: Durr Dental SE. Cleared Aug 2025. https://www.510kdatabase.net/k251068/ 2025-08-27 monthly 0.8 https://www.510kdatabase.net/og-image/k251068-knoxfog-anti-fogging-device-fda-510k.jpg K251068 - KnoxFog Anti-fogging Device K251068 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Uv One Hygienics, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k251382/ 2025-08-27 monthly 0.8 https://www.510kdatabase.net/og-image/k251382-phoenix-sinus-tarsi-stent-system-fda-510k.jpg K251382 - Phoenix Sinus Tarsi Stent System K251382 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Astra Orthomed, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k251415/ 2025-08-27 monthly 0.8 https://www.510kdatabase.net/og-image/k251415-additively-manufactured-aligner-resin-fda-510k.jpg K251415 - Additively Manufactured Aligner Resin K251415 is a FDA 510(k) cleared dental medical device. Manufacturer: Aidite (Qinhuangdao) Technology Co., Ltd.. Cleared Aug 2025. https://www.510kdatabase.net/k251637/ 2025-08-27 monthly 0.8 https://www.510kdatabase.net/og-image/k251637-dewin-reproductive-media-dewin-gamete-fda-510k.jpg K251637 - Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA] K251637 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Donnevie Medical Technology (Shanghai) Co. , Ltd.. Cleared Aug 2025. https://www.510kdatabase.net/k251716/ 2025-08-27 monthly 0.8 https://www.510kdatabase.net/og-image/k251716-nitrile-powder-free-exam-gloves-tested-fda-510k.jpg K251716 - Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate K251716 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Basic Medical Technology, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k251752/ 2025-08-27 monthly 0.8 https://www.510kdatabase.net/og-image/k251752-flexible-bronchoscope-bs27u-12eu-bs27u-fda-510k.jpg K251752 - Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US) K251752 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Shanghai AnQing Medical Instrument Co., Ltd.. Cleared Aug 2025. https://www.510kdatabase.net/k252118/ 2025-08-27 monthly 0.8 https://www.510kdatabase.net/og-image/k252118-clungene-multi-drug-test-easy-cup-fda-510k.jpg K252118 - CLUNGENE Multi-Drug Test Easy Cup K252118 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Hangzhou Clongene Biotech Co., Ltd.. Cleared Aug 2025. https://www.510kdatabase.net/k252419/ 2025-08-27 monthly 0.8 https://www.510kdatabase.net/og-image/k252419-hotwire-rf-guidewire-901xxx-fda-510k.jpg K252419 - HOTWIRE RF GUIDEWIRE (901XXX) K252419 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Atraverse Medical, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k244061/ 2025-08-26 monthly 0.8 https://www.510kdatabase.net/og-image/k244061-x-wire-guidewire-fda-510k.jpg K244061 - X-Wire Guidewire K244061 is a FDA 510(k) cleared neurology medical device. Manufacturer: Imperative Care, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k250049/ 2025-08-26 monthly 0.8 https://www.510kdatabase.net/og-image/k250049-medical-video-endoscope-standard-fda-510k.jpg K250049 - Medical Video Endoscope [Standard Deflection] (URS3005) K250049 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Seplou (Zhuhai) Co., Ltd.. Cleared Aug 2025. https://www.510kdatabase.net/k250261/ 2025-08-26 monthly 0.8 https://www.510kdatabase.net/og-image/k250261-heager-medical-laser-family-sabrinaadolf-fda-510k.jpg K250261 - Heager Medical Laser Family (Sabrina/Adolf) K250261 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Heager GmbH. Cleared Aug 2025. https://www.510kdatabase.net/k251305/ 2025-08-26 monthly 0.8 https://www.510kdatabase.net/og-image/k251305-ultra-fast-vitri-fda-510k.jpg K251305 - Ultra-Fast Vitri K251305 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Kitazato Corporation. Cleared Aug 2025. https://www.510kdatabase.net/k251983/ 2025-08-26 monthly 0.8 https://www.510kdatabase.net/og-image/k251983-brainomix-360-triage-stroke-fda-510k.jpg K251983 - Brainomix 360 Triage Stroke K251983 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainomix Limited. Cleared Aug 2025. https://www.510kdatabase.net/k252526/ 2025-08-26 monthly 0.8 https://www.510kdatabase.net/og-image/k252526-rapid-deltafuse-fda-510k.jpg K252526 - Rapid DeltaFuse K252526 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ischemaview, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k243634/ 2025-08-25 monthly 0.8 https://www.510kdatabase.net/og-image/k243634-maxx-libertas-bipolar-hip-head-bipolar-fda-510k.jpg K243634 - Maxx Libertas Bipolar Hip Head (Bipolar Hip) K243634 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Maxx Orthopedics, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k243680/ 2025-08-25 monthly 0.8 https://www.510kdatabase.net/og-image/k243680-neurovascular-insight-v10-fda-510k.jpg K243680 - Neurovascular Insight V1.0 K243680 is a FDA 510(k) cleared radiology medical device. Manufacturer: Olea Medical S.A.S.. Cleared Aug 2025. https://www.510kdatabase.net/k243709/ 2025-08-25 monthly 0.8 https://www.510kdatabase.net/og-image/k243709-neuroears-anna-fda-510k.jpg K243709 - NeuroEars-Anna™ K243709 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Neuroears, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k243800/ 2025-08-25 monthly 0.8 https://www.510kdatabase.net/og-image/k243800-pro-pen-microneedling-system-6883-fda-510k.jpg K243800 - PRO Pen Microneedling System (6883) K243800 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Dermalogica, LLC. Cleared Aug 2025. https://www.510kdatabase.net/k243834/ 2025-08-25 monthly 0.8 https://www.510kdatabase.net/og-image/k243834-nobelzygoma-tiultra-implant-system-fda-510k.jpg K243834 - NobelZygoma TiUltra Implant system K243834 is a FDA 510(k) cleared dental medical device. Manufacturer: Nobel Biocare AB. Cleared Aug 2025. https://www.510kdatabase.net/k251246/ 2025-08-25 monthly 0.8 https://www.510kdatabase.net/og-image/k251246-sparrow-ascent-fda-510k.jpg K251246 - Sparrow Ascent K251246 is a FDA 510(k) cleared neurology medical device. Manufacturer: Spark Biomedical, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k251404/ 2025-08-25 monthly 0.8 https://www.510kdatabase.net/og-image/k251404-quantra-qstat-cartridge-fda-510k.jpg K251404 - Quantra QStat Cartridge K251404 is a FDA 510(k) cleared hematology medical device. Manufacturer: Hemosonics, LLC. Cleared Aug 2025. https://www.510kdatabase.net/k251440/ 2025-08-25 monthly 0.8 https://www.510kdatabase.net/og-image/k251440-cryocheck-chromogenic-factor-viii-fda-510k.jpg K251440 - CRYOcheck Chromogenic Factor VIII K251440 is a FDA 510(k) cleared hematology medical device. Manufacturer: Precision Biologic, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k251593/ 2025-08-25 monthly 0.8 https://www.510kdatabase.net/og-image/k251593-denmat-multilayered-zirconia-disc-fda-510k.jpg K251593 - DenMat Multilayered Zirconia Disc K251593 is a FDA 510(k) cleared dental medical device. Manufacturer: Denmat Holding, LLC. Cleared Aug 2025. https://www.510kdatabase.net/k251811/ 2025-08-25 monthly 0.8 https://www.510kdatabase.net/og-image/k251811-motor-and-apex-module-maam-fda-510k.jpg K251811 - Motor and Apex Module (MaAM) K251811 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k243660/ 2025-08-22 monthly 0.8 https://www.510kdatabase.net/og-image/k243660-monoject-1ml-tuberculin-syringe-luer-fda-510k.jpg K243660 - Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777) K243660 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cardinalhealth. Cleared Aug 2025. https://www.510kdatabase.net/k243685/ 2025-08-22 monthly 0.8 https://www.510kdatabase.net/og-image/k243685-mammoscreen-bd-fda-510k.jpg K243685 - MammoScreen BD K243685 is a FDA 510(k) cleared radiology medical device. Manufacturer: Therapixel. Cleared Aug 2025. https://www.510kdatabase.net/k243692/ 2025-08-22 monthly 0.8 https://www.510kdatabase.net/og-image/k243692-endrive-endriveus-fda-510k.jpg K243692 - EnDrive (EnDriveUS) K243692 is a FDA 510(k) cleared dental medical device. Manufacturer: Advanced Technology Research (A.T.R.) S.R.L.. Cleared Aug 2025. https://www.510kdatabase.net/k250147/ 2025-08-22 monthly 0.8 https://www.510kdatabase.net/og-image/k250147-cps-locator-3d-delivery-catheter-fda-510k.jpg K250147 - CPS Locator 3D Delivery Catheter K250147 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Centerpoint Systems. Cleared Aug 2025. https://www.510kdatabase.net/k251192/ 2025-08-22 monthly 0.8 https://www.510kdatabase.net/og-image/k251192-diagnostic-ultrasound-system-mx7-fda-510k.jpg K251192 - Diagnostic Ultrasound System (MX7) K251192 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Aug 2025. https://www.510kdatabase.net/k251277/ 2025-08-22 monthly 0.8 https://www.510kdatabase.net/og-image/k251277-coraforce-microcatheter-coraflex-fda-510k.jpg K251277 - CoraForce Microcatheter, CoraFlex Microcatheter K251277 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Reflow Medical, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k251443/ 2025-08-22 monthly 0.8 https://www.510kdatabase.net/og-image/k251443-promo-fda-510k.jpg K251443 - PROMO K251443 is a FDA 510(k) cleared radiology medical device. Manufacturer: DRGEM Corporation. Cleared Aug 2025. https://www.510kdatabase.net/k251604/ 2025-08-22 monthly 0.8 https://www.510kdatabase.net/og-image/k251604-caresuperb-covid-19flu-ab-antigen-fda-510k.jpg K251604 - CareSuperb COVID-19/Flu A&B Antigen Combo Home Test K251604 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Access Bio, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k251828/ 2025-08-22 monthly 0.8 https://www.510kdatabase.net/og-image/k251828-cereglide-71-catheter-system-fda-510k.jpg K251828 - CEREGLIDE 71 Catheter System K251828 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cerenovus, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k251884/ 2025-08-22 monthly 0.8 https://www.510kdatabase.net/og-image/k251884-one-fil-putty-injectable-fda-510k.jpg K251884 - One-Fil Putty Injectable K251884 is a FDA 510(k) cleared dental medical device. Manufacturer: Mediclus Co., Ltd.. Cleared Aug 2025. https://www.510kdatabase.net/k252302/ 2025-08-22 monthly 0.8 https://www.510kdatabase.net/og-image/k252302-carto-3-ep-navigation-system-v81-fda-510k.jpg K252302 - CARTO™ 3 EP Navigation System V8.1 K252302 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biosense Webster, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k252303/ 2025-08-22 monthly 0.8 https://www.510kdatabase.net/og-image/k252303-stem-extension-line-ustar-ii-system-fda-510k.jpg K252303 - Stem Extension Line (USTAR II System) K252303 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: United Orthopedic Corporation. Cleared Aug 2025. https://www.510kdatabase.net/k252362/ 2025-08-22 monthly 0.8 https://www.510kdatabase.net/og-image/k252362-gbrain-mri-fda-510k.jpg K252362 - GBrain MRI K252362 is a FDA 510(k) cleared radiology medical device. Manufacturer: Galileo Cds, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k241152/ 2025-08-21 monthly 0.8 https://www.510kdatabase.net/og-image/k241152-insee-fda-510k.jpg K241152 - InSee K241152 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Tidal Medical Technologies, LLC. Cleared Aug 2025. https://www.510kdatabase.net/k243965/ 2025-08-21 monthly 0.8 https://www.510kdatabase.net/og-image/k243965-origin-fda-510k.jpg K243965 - Origin™ K243965 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Nerv Technology Inc. (D.B.A.) Fluidai Medical. Cleared Aug 2025. https://www.510kdatabase.net/k250784/ 2025-08-21 monthly 0.8 https://www.510kdatabase.net/og-image/k250784-transcutaneous-electrical-nerve-fda-510k.jpg K250784 - Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ K6138/ K6139/ K6140/ K6141/ K6142/ K6143/ K6144/ K6122) K250784 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Yicai Health Technology Co., Ltd.. Cleared Aug 2025. https://www.510kdatabase.net/k250923/ 2025-08-21 monthly 0.8 https://www.510kdatabase.net/og-image/k250923-fine-osteotomy-fda-510k.jpg K250923 - Fine Osteotomy™ K250923 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Bodycad Laboratories, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k250994/ 2025-08-21 monthly 0.8 https://www.510kdatabase.net/og-image/k250994-cleartip-fna-and-fnb-types-fda-510k.jpg K250994 - ClearTip FNA and FNB Types K250994 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Finemedix Co., Ltd.. Cleared Aug 2025. https://www.510kdatabase.net/k251029/ 2025-08-21 monthly 0.8 https://www.510kdatabase.net/og-image/k251029-vista-os-vista-ai-scan-rthawk-fda-510k.jpg K251029 - Vista OS, Vista AI Scan, RTHawk K251029 is a FDA 510(k) cleared radiology medical device. Manufacturer: Vista AI, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k251130/ 2025-08-21 monthly 0.8 https://www.510kdatabase.net/og-image/k251130-portable-oxygen-concentrator-jm-p50a-fda-510k.jpg K251130 - Portable Oxygen Concentrator (JM-P50A) K251130 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Jiangsu Jumao X-Care Medical Equipment Co., Ltd.. Cleared Aug 2025. https://www.510kdatabase.net/k251135/ 2025-08-21 monthly 0.8 https://www.510kdatabase.net/og-image/k251135-treace-medical-concepts-tmc-implant-fda-510k.jpg K251135 - Treace Medical Concepts (TMC) Implant Fixation System K251135 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Treace Medical Concepts. Cleared Aug 2025. https://www.510kdatabase.net/k251579/ 2025-08-21 monthly 0.8 https://www.510kdatabase.net/og-image/k251579-vitek-2-ast-gram-negative-cefazolin-1-fda-510k.jpg K251579 - VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) K251579 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k251588/ 2025-08-21 monthly 0.8 https://www.510kdatabase.net/og-image/k251588-led-light-therapy-mask-fcm902-fcm905-fda-510k.jpg K251588 - LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910) K251588 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Fittop Health Technology Co., Ltd.. Cleared Aug 2025. https://www.510kdatabase.net/k251647/ 2025-08-21 monthly 0.8 https://www.510kdatabase.net/og-image/k251647-mis-c1-implant-system-mis-seven-fda-510k.jpg K251647 - MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Connection System K251647 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k252244/ 2025-08-21 monthly 0.8 https://www.510kdatabase.net/og-image/k252244-disposable-powder-free-nitrile-fda-510k.jpg K252244 - Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, Xylazine, Gastric acid, Fentanyl in Gastric acid and Xylazine in Gastric acid K252244 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ever Global (Vietnam) Enterprise Corporation. Cleared Aug 2025. https://www.510kdatabase.net/k252356/ 2025-08-21 monthly 0.8 https://www.510kdatabase.net/og-image/k252356-the-acumed-wrist-fixation-system-24mm-fda-510k.jpg K252356 - The Acumed Wrist Fixation System - 2.4mm Screws K252356 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Acumed, LLC. Cleared Aug 2025. https://www.510kdatabase.net/k243804/ 2025-08-20 monthly 0.8 https://www.510kdatabase.net/og-image/k243804-microscan-dried-gram-negative-miccombo-fda-510k.jpg K243804 - MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL) (MicroScan) K243804 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k250383/ 2025-08-20 monthly 0.8 https://www.510kdatabase.net/og-image/k250383-wearable-breast-pump-model-w6-fda-510k.jpg K250383 - Wearable Breast Pump (Model W6) K250383 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shenzhen TPH Technology Co., Ltd.. Cleared Aug 2025. https://www.510kdatabase.net/k250417/ 2025-08-20 monthly 0.8 https://www.510kdatabase.net/og-image/k250417-remanufactured-endowrist-cobra-grasper-fda-510k.jpg K250417 - Remanufactured EndoWrist Cobra Grasper (420190) K250417 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Rebotix. Cleared Aug 2025. https://www.510kdatabase.net/k250721/ 2025-08-20 monthly 0.8 https://www.510kdatabase.net/og-image/k250721-locator-angled-abutment-fda-510k.jpg K250721 - LOCATOR® Angled Abutment K250721 is a FDA 510(k) cleared dental medical device. Manufacturer: Zest Anchors, LLC. Cleared Aug 2025. https://www.510kdatabase.net/k251229/ 2025-08-20 monthly 0.8 https://www.510kdatabase.net/og-image/k251229-endofixtissue-fixation-system-fda-510k.jpg K251229 - EndoFix™Tissue Fixation System K251229 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Softac Medical Technologies. Cleared Aug 2025. https://www.510kdatabase.net/k251400/ 2025-08-20 monthly 0.8 https://www.510kdatabase.net/og-image/k251400-t2-alpha-humerus-nailing-system-fda-510k.jpg K251400 - T2 Alpha Humerus Nailing System K251400 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker GmbH. Cleared Aug 2025. https://www.510kdatabase.net/k251471/ 2025-08-20 monthly 0.8 https://www.510kdatabase.net/og-image/k251471-ipd-dental-implant-abutments-fda-510k.jpg K251471 - IPD Dental Implant Abutments K251471 is a FDA 510(k) cleared dental medical device. Manufacturer: Implant Protesis Dental 2004, S.L.. Cleared Aug 2025. https://www.510kdatabase.net/k251481/ 2025-08-20 monthly 0.8 https://www.510kdatabase.net/og-image/k251481-acuson-sequoia-diagnostic-ultrasound-fda-510k.jpg K251481 - ACUSON Sequoia Diagnostic Ultrasound System K251481 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k251563/ 2025-08-20 monthly 0.8 https://www.510kdatabase.net/og-image/k251563-welllife-flu-ab-home-test-fda-510k.jpg K251563 - WELLlife Flu A&B Home Test K251563 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Wondfo USA Co., Ltd.. Cleared Aug 2025. https://www.510kdatabase.net/k251580/ 2025-08-20 monthly 0.8 https://www.510kdatabase.net/og-image/k251580-mts-sulbactam-durlobactam-00044-644-fda-510k.jpg K251580 - MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD) K251580 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Liofilchem S. R. L.. Cleared Aug 2025. https://www.510kdatabase.net/k251590/ 2025-08-20 monthly 0.8 https://www.510kdatabase.net/og-image/k251590-methinks-cta-stroke-fda-510k.jpg K251590 - Methinks CTA Stroke K251590 is a FDA 510(k) cleared radiology medical device. Manufacturer: Methinks Software, S.L. Cleared Aug 2025. https://www.510kdatabase.net/k251837/ 2025-08-20 monthly 0.8 https://www.510kdatabase.net/og-image/k251837-salix-coronary-plaque-v100-fda-510k.jpg K251837 - Salix Coronary Plaque (V1.0.0) K251837 is a FDA 510(k) cleared radiology medical device. Manufacturer: Artrya Limited. Cleared Aug 2025. https://www.510kdatabase.net/k252061/ 2025-08-20 monthly 0.8 https://www.510kdatabase.net/og-image/k252061-distal-xtremities-system-fda-510k.jpg K252061 - Distal Xtremities System K252061 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: TriMed, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k252104/ 2025-08-20 monthly 0.8 https://www.510kdatabase.net/og-image/k252104-t1d1-fda-510k.jpg K252104 - T1D1 K252104 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Comerge AG. Cleared Aug 2025. https://www.510kdatabase.net/den250002/ 2025-08-20 monthly 0.8 https://www.510kdatabase.net/og-image/den250002-delphi-md-system-fda-510k.jpg DEN250002 - Delphi-MD System DEN250002 is a FDA 510(k) cleared neurology medical device. Manufacturer: Quantalx Neuroscience, Ltd.. Cleared Aug 2025. https://www.510kdatabase.net/k243713/ 2025-08-19 monthly 0.8 https://www.510kdatabase.net/og-image/k243713-single-use-rf-surgical-electrode-fda-510k.jpg K243713 - Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A) K243713 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Agnes Medical Co., Ltd.. Cleared Aug 2025. https://www.510kdatabase.net/k250313/ 2025-08-19 monthly 0.8 https://www.510kdatabase.net/og-image/k250313-sterile-powder-free-synthetic-rubber-fda-510k.jpg K250313 - Sterile Powder Free Synthetic Rubber Surgeon’s Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid K250313 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Harps Europe Manufacturing GmbH. Cleared Aug 2025. https://www.510kdatabase.net/k250387/ 2025-08-19 monthly 0.8 https://www.510kdatabase.net/og-image/k250387-remanufactured-endowrist-long-tip-fda-510k.jpg K250387 - Remanufactured EndoWrist Long Tip Forceps (420048) K250387 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Rebotix. Cleared Aug 2025. https://www.510kdatabase.net/k250399/ 2025-08-19 monthly 0.8 https://www.510kdatabase.net/og-image/k250399-remanufactured-endowrist-cadiere-fda-510k.jpg K250399 - Remanufactured EndoWrist Cadiere Forceps (420049) K250399 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Rebotix. Cleared Aug 2025. https://www.510kdatabase.net/k250539/ 2025-08-19 monthly 0.8 https://www.510kdatabase.net/og-image/k250539-remanufactured-endowrist-tenaculum-fda-510k.jpg K250539 - Remanufactured EndoWrist Tenaculum Forceps (420207) K250539 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Rebotix. Cleared Aug 2025. https://www.510kdatabase.net/k252022/ 2025-08-19 monthly 0.8 https://www.510kdatabase.net/og-image/k252022-ossiofiber-interference-screw-fda-510k.jpg K252022 - OSSIOfiber® Interference Screw K252022 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OSSIO , Ltd.. Cleared Aug 2025. https://www.510kdatabase.net/k252316/ 2025-08-19 monthly 0.8 https://www.510kdatabase.net/og-image/k252316-venclose-digirf-generator-vcrfg1-fda-510k.jpg K252316 - Venclose digiRF Generator (VCRFG1) K252316 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Venclose, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k243539/ 2025-08-18 monthly 0.8 https://www.510kdatabase.net/og-image/k243539-apollo-tms-therapy-system-fda-510k.jpg K243539 - Apollo TMS Therapy System K243539 is a FDA 510(k) cleared neurology medical device. Manufacturer: Mag & More GmbH. Cleared Aug 2025. https://www.510kdatabase.net/k243604/ 2025-08-18 monthly 0.8 https://www.510kdatabase.net/og-image/k243604-halyard-purple-nitrile-xtra-powder-fda-510k.jpg K243604 - Halyard Purple Nitrile-XTRA* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Fentanyl Citrate in Simulated Gastric Acid K243604 is a FDA 510(k) cleared general hospital medical device. Manufacturer: O&M Halyard, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k250167/ 2025-08-18 monthly 0.8 https://www.510kdatabase.net/og-image/k250167-evolution-spine-navigation-instruments-fda-510k.jpg K250167 - Evolution Spine Navigation Instruments K250167 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Evolution Spine. Cleared Aug 2025. https://www.510kdatabase.net/k250271/ 2025-08-18 monthly 0.8 https://www.510kdatabase.net/og-image/k250271-neodent-implant-system-zirconia-fda-510k.jpg K250271 - Neodent Implant System - Zirconia Implant System K250271 is a FDA 510(k) cleared dental medical device. Manufacturer: JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A.. Cleared Aug 2025. https://www.510kdatabase.net/k251086/ 2025-08-18 monthly 0.8 https://www.510kdatabase.net/og-image/k251086-pnueaira-pncu-01-fda-510k.jpg K251086 - PnueAira (PNCU-01) K251086 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biotab, LLC. Cleared Aug 2025. https://www.510kdatabase.net/k251161/ 2025-08-18 monthly 0.8 https://www.510kdatabase.net/og-image/k251161-anthem-fracture-system-fda-510k.jpg K251161 - ANTHEM® Fracture System K251161 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k251913/ 2025-08-16 monthly 0.8 https://www.510kdatabase.net/og-image/k251913-osteocentric-unifimi-tcs-plating-system-fda-510k.jpg K251913 - OsteoCentric® UnifiMI® TCS Plating System K251913 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OsteoCentric Technologies. Cleared Aug 2025. https://www.510kdatabase.net/k243650/ 2025-08-15 monthly 0.8 https://www.510kdatabase.net/og-image/k243650-zio-monitor-dfg0001-fda-510k.jpg K243650 - Zio® monitor (DFG0001) K243650 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: iRhythm Technologies, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k243851/ 2025-08-15 monthly 0.8 https://www.510kdatabase.net/og-image/k243851-chloe-blast-fda-510k.jpg K243851 - CHLOE BLAST K243851 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Fairtility , Ltd.. Cleared Aug 2025. https://www.510kdatabase.net/k250036/ 2025-08-15 monthly 0.8 https://www.510kdatabase.net/og-image/k250036-microscan-dried-gram-positive-miccombo-fda-510k.jpg K250036 - MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL) K250036 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k250170/ 2025-08-15 monthly 0.8 https://www.510kdatabase.net/og-image/k250170-pharos-fda-510k.jpg K250170 - PHAROS K250170 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brightonix Imaging. Cleared Aug 2025. https://www.510kdatabase.net/k250397/ 2025-08-15 monthly 0.8 https://www.510kdatabase.net/og-image/k250397-helios-dermal-scaffold-fda-510k.jpg K250397 - Helios Dermal Scaffold K250397 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Helios Biomedical, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k250620/ 2025-08-15 monthly 0.8 https://www.510kdatabase.net/og-image/k250620-kls-martin-ixos-system-fda-510k.jpg K250620 - KLS Martin Ixos System K250620 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: KLS-Martin L.P.. Cleared Aug 2025. https://www.510kdatabase.net/k250818/ 2025-08-15 monthly 0.8 https://www.510kdatabase.net/og-image/k250818-nerveblox-fda-510k.jpg K250818 - Nerveblox K250818 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Smart Alfa Teknoloji San. Ve Tic. A.S.. Cleared Aug 2025. https://www.510kdatabase.net/k250867/ 2025-08-15 monthly 0.8 https://www.510kdatabase.net/og-image/k250867-dunamis-screw-and-suture-locking-system-fda-510k.jpg K250867 - Dunamis Screw and Suture Locking System K250867 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Dunamis Medical, LLC. Cleared Aug 2025. https://www.510kdatabase.net/k251243/ 2025-08-15 monthly 0.8 https://www.510kdatabase.net/og-image/k251243-onerf-trigeminal-nerve-radiofrequency-fda-510k.jpg K251243 - OneRF Trigeminal Nerve Radiofrequency Probes K251243 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neuroone Medical Technologies Corp.. Cleared Aug 2025. https://www.510kdatabase.net/k251747/ 2025-08-15 monthly 0.8 https://www.510kdatabase.net/og-image/k251747-vea-align-fda-510k.jpg K251747 - VEA Align K251747 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eos Imaging. Cleared Aug 2025. https://www.510kdatabase.net/k251834/ 2025-08-15 monthly 0.8 https://www.510kdatabase.net/og-image/k251834-persona-partial-knee-fda-510k.jpg K251834 - Persona Partial Knee K251834 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer Biomet. Cleared Aug 2025. https://www.510kdatabase.net/k251871/ 2025-08-15 monthly 0.8 https://www.510kdatabase.net/og-image/k251871-feather-01-02-03-04-model01-fda-510k.jpg K251871 - FEATHER 01 02 03 04 (Model:01) K251871 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Heat IN A Click, LLC. Cleared Aug 2025. https://www.510kdatabase.net/k251877/ 2025-08-15 monthly 0.8 https://www.510kdatabase.net/og-image/k251877-jms-caveo-av-fistula-needle-set-fda-510k.jpg K251877 - JMS CAVEO A.V. Fistula Needle Set K251877 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: JMS North America Corporation. Cleared Aug 2025. https://www.510kdatabase.net/k251969/ 2025-08-15 monthly 0.8 https://www.510kdatabase.net/og-image/k251969-atlas-spine-project-x-expandable-fda-510k.jpg K251969 - Atlas Spine Project X Expandable Posterior Lumbar Interbody System K251969 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Atlas Spine, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k251972/ 2025-08-15 monthly 0.8 https://www.510kdatabase.net/og-image/k251972-healgen-accufluor-fentanyl-fda-510k.jpg K251972 - Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative K251972 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Healgen Scientific, LLC. Cleared Aug 2025. https://www.510kdatabase.net/k252236/ 2025-08-15 monthly 0.8 https://www.510kdatabase.net/og-image/k252236-cp-relief-wand-rx-tensnmes-fda-510k.jpg K252236 - CP Relief Wand Rx - TENS/NMES K252236 is a FDA 510(k) cleared neurology medical device. Manufacturer: N & C Holdings, LLC. Cleared Aug 2025. https://www.510kdatabase.net/k252259/ 2025-08-15 monthly 0.8 https://www.510kdatabase.net/og-image/k252259-assuretech-quick-cup-tests-fda-510k.jpg K252259 - AssureTech Quick Cup Tests K252259 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Assure Tech., LLC. Cleared Aug 2025. https://www.510kdatabase.net/k243437/ 2025-08-14 monthly 0.8 https://www.510kdatabase.net/og-image/k243437-mom-essential-incubator-me1-fda-510k.jpg K243437 - mOm Essential Incubator (ME1) K243437 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Mom Incubators Limited. Cleared Aug 2025. https://www.510kdatabase.net/k243544/ 2025-08-14 monthly 0.8 https://www.510kdatabase.net/og-image/k243544-biofire-spotfire-respiratorysore-fda-510k.jpg K243544 - BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini K243544 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Biofire Diagnostics, LLC. Cleared Aug 2025. https://www.510kdatabase.net/k243600/ 2025-08-14 monthly 0.8 https://www.510kdatabase.net/og-image/k243600-3nethra-neo-hd-fa-fda-510k.jpg K243600 - 3nethra neo HD FA K243600 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Forus Health Pvt.Ltd. Cleared Aug 2025. https://www.510kdatabase.net/k243905/ 2025-08-14 monthly 0.8 https://www.510kdatabase.net/og-image/k243905-stitch-cerclage-suture-tapes-fda-510k.jpg K243905 - Stitch Cerclage – Suture Tapes K243905 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: GM Dos Reis Industria e Comercio Ltda.. Cleared Aug 2025. https://www.510kdatabase.net/k250164/ 2025-08-14 monthly 0.8 https://www.510kdatabase.net/og-image/k250164-cassette-autoclave-aca5-fda-510k.jpg K250164 - Cassette Autoclave (ACA5) K250164 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guangzhou Ajax Medical Equipment Co., Ltd.. Cleared Aug 2025. https://www.510kdatabase.net/k250898/ 2025-08-14 monthly 0.8 https://www.510kdatabase.net/og-image/k250898-reprocessed-harmonic-700-shears-fda-510k.jpg K250898 - Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm Diameter Shears with Advanced Hemostasis x 23cm) K250898 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker Sustainability Solutions. Cleared Aug 2025. https://www.510kdatabase.net/k250916/ 2025-08-14 monthly 0.8 https://www.510kdatabase.net/og-image/k250916-winforth-lm-e470ka-fda-510k.jpg K250916 - WinForth (LM-E470KA) K250916 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Leaflife Technology Co., Ltd.. Cleared Aug 2025. https://www.510kdatabase.net/k251012/ 2025-08-14 monthly 0.8 https://www.510kdatabase.net/og-image/k251012-trudermal-pro-zld-390-fda-510k.jpg K251012 - TRUDERMAL Pro (ZLD-390) K251012 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Kaiyan Medical Equipment Co., Ltd.. Cleared Aug 2025. https://www.510kdatabase.net/k251062/ 2025-08-14 monthly 0.8 https://www.510kdatabase.net/og-image/k251062-geistlich-bio-gide-fda-510k.jpg K251062 - Geistlich Bio-Gide K251062 is a FDA 510(k) cleared dental medical device. Manufacturer: Geistlich Pharma AG. Cleared Aug 2025. https://www.510kdatabase.net/k251176/ 2025-08-14 monthly 0.8 https://www.510kdatabase.net/og-image/k251176-ipl-hair-removal-device-models-t14b-fda-510k.jpg K251176 - IPL Hair Removal Device (Model(s): T14B, T16B, T19B, T15B, T17C, T18B, T21A, T21B, T21C, T21D, T22A, T22B, T25B, T25C) K251176 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Mlay Intelligent Technology Co., Ltd.. Cleared Aug 2025. https://www.510kdatabase.net/k251526/ 2025-08-14 monthly 0.8 https://www.510kdatabase.net/og-image/k251526-filmarray-gi-control-panel-m238-fda-510k.jpg K251526 - FilmArray GI Control Panel M238 K251526 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Maine Molecular Quality Controls, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k243279/ 2025-08-13 monthly 0.8 https://www.510kdatabase.net/og-image/k243279-dolorclast-focused-shock-waves-fda-510k.jpg K243279 - DOLORCLAST Focused Shock Waves K243279 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: E.M.S Electro Medical Systems S.A. Cleared Aug 2025. https://www.510kdatabase.net/k243579/ 2025-08-13 monthly 0.8 https://www.510kdatabase.net/og-image/k243579-aerojet-ventilation-catheter-fda-510k.jpg K243579 - AeroJet Ventilation Catheter K243579 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Pipeline Medical Products, LLC. Cleared Aug 2025. https://www.510kdatabase.net/k243653/ 2025-08-13 monthly 0.8 https://www.510kdatabase.net/og-image/k243653-karl-storz-hopkins-telescopes-for-fda-510k.jpg K243653 - KARL STORZ HOPKINS Telescopes for Urology K243653 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Karl Storz SE & CO. KG. Cleared Aug 2025. https://www.510kdatabase.net/k250163/ 2025-08-13 monthly 0.8 https://www.510kdatabase.net/og-image/k250163-t2-alpha-femur-retrograde-nailing-system-fda-510k.jpg K250163 - T2 Alpha Femur Retrograde Nailing System K250163 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker GmbH. Cleared Aug 2025. https://www.510kdatabase.net/k250841/ 2025-08-13 monthly 0.8 https://www.510kdatabase.net/og-image/k250841-electrotherapy-electrodes-fda-510k.jpg K250841 - Electrotherapy Electrodes K250841 is a FDA 510(k) cleared neurology medical device. Manufacturer: Baisheng Medical Co., Ltd.. Cleared Aug 2025. https://www.510kdatabase.net/k250931/ 2025-08-13 monthly 0.8 https://www.510kdatabase.net/og-image/k250931-unimed-reusable-spo2-sensors-117-and-fda-510k.jpg K250931 - Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117) K250931 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Unimed Medical Supplies, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k251033/ 2025-08-13 monthly 0.8 https://www.510kdatabase.net/og-image/k251033-unscented-menstrual-long-applicator-fda-510k.jpg K251033 - Unscented menstrual long applicator tampon K251033 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Unibeauty (Hubei) Technology Co., Ltd.. Cleared Aug 2025. https://www.510kdatabase.net/k251046/ 2025-08-13 monthly 0.8 https://www.510kdatabase.net/og-image/k251046-sin-dental-implant-system-fda-510k.jpg K251046 - S.I.N. Dental Implant System K251046 is a FDA 510(k) cleared dental medical device. Manufacturer: S.I.N. Implant System Ltda. Cleared Aug 2025. https://www.510kdatabase.net/k251495/ 2025-08-13 monthly 0.8 https://www.510kdatabase.net/og-image/k251495-mbt-compass-ht-ca-software-fda-510k.jpg K251495 - MBT Compass HT CA Software K251495 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bruker Daltonics GmbH & Co. KG. Cleared Aug 2025. https://www.510kdatabase.net/k251519/ 2025-08-13 monthly 0.8 https://www.510kdatabase.net/og-image/k251519-relievrx-pico-g3-fda-510k.jpg K251519 - RelieVRx (Pico G3) K251519 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Appliedvr. Cleared Aug 2025. https://www.510kdatabase.net/k251569/ 2025-08-13 monthly 0.8 https://www.510kdatabase.net/og-image/k251569-bone-screw-fda-510k.jpg K251569 - Bone Screw K251569 is a FDA 510(k) cleared dental medical device. Manufacturer: Osstem Implant Co., Ltd.. Cleared Aug 2025. https://www.510kdatabase.net/k252192/ 2025-08-13 monthly 0.8 https://www.510kdatabase.net/og-image/k252192-wearable-breast-pump-p9-p10-p16-p20-fda-510k.jpg K252192 - Wearable Breast Pump (P9, P10, P16, P20, P21, P22, P23, P25) K252192 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Huizhou Lvb Maternal and Infant Supplies Co., Ltd.. Cleared Aug 2025. https://www.510kdatabase.net/k252201/ 2025-08-13 monthly 0.8 https://www.510kdatabase.net/og-image/k252201-hs-fiber-fda-510k.jpg K252201 - HS Fiber K252201 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Riverpoint Medical. Cleared Aug 2025. https://www.510kdatabase.net/k252226/ 2025-08-13 monthly 0.8 https://www.510kdatabase.net/og-image/k252226-dual-lumen-extended-length-catheter-fda-510k.jpg K252226 - Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101) K252226 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Nuwellis, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k243562/ 2025-08-12 monthly 0.8 https://www.510kdatabase.net/og-image/k243562-cuffguard-fda-510k.jpg K243562 - CuffGuard K243562 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Idmed. Cleared Aug 2025. https://www.510kdatabase.net/k250294/ 2025-08-12 monthly 0.8 https://www.510kdatabase.net/og-image/k250294-straumann-ridgefit-implants-fda-510k.jpg K250294 - Straumann® RidgeFit Implants K250294 is a FDA 510(k) cleared dental medical device. Manufacturer: Institut Straumann AG. Cleared Aug 2025. https://www.510kdatabase.net/k250755/ 2025-08-12 monthly 0.8 https://www.510kdatabase.net/og-image/k250755-ds-core-diagnosis-fda-510k.jpg K250755 - DS Core Diagnosis K250755 is a FDA 510(k) cleared radiology medical device. Manufacturer: Dentsply Sirona, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k250836/ 2025-08-12 monthly 0.8 https://www.510kdatabase.net/og-image/k250836-14f-duo-flow-side-x-side-double-lumen-fda-510k.jpg K250836 - 14F Duo-Flow® Side X Side Double Lumen Catheter K250836 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medical Components, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k251494/ 2025-08-12 monthly 0.8 https://www.510kdatabase.net/og-image/k251494-eko-foundation-analysis-software-with-fda-510k.jpg K251494 - Eko Foundation Analysis Software with Transformers (EFAST) K251494 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Eko Health, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k251879/ 2025-08-12 monthly 0.8 https://www.510kdatabase.net/og-image/k251879-sulopenem-spm-2-g-fda-510k.jpg K251879 - Sulopenem SPM 2 µg K251879 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Liofilchem. Cleared Aug 2025. https://www.510kdatabase.net/k252083/ 2025-08-12 monthly 0.8 https://www.510kdatabase.net/og-image/k252083-hotwire-system-rf-generator-and-fda-510k.jpg K252083 - HOTWIRE™ System RF Generator and Footswitch (optional accessory) K252083 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Atraverse Medical, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k232456/ 2025-08-11 monthly 0.8 https://www.510kdatabase.net/og-image/k232456-rw-1-fda-510k.jpg K232456 - RW-1 K232456 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mediott, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k241731/ 2025-08-11 monthly 0.8 https://www.510kdatabase.net/og-image/k241731-outlook-surgical-versa-one-system-fda-510k.jpg K241731 - Outlook Surgical Versa One System (8900139) K241731 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Resnent, LLC. Cleared Aug 2025. https://www.510kdatabase.net/k250207/ 2025-08-11 monthly 0.8 https://www.510kdatabase.net/og-image/k250207-eufy-wearable-breast-pump-s1-t8d02-fda-510k.jpg K250207 - eufy Wearable Breast Pump S1 (T8D02) K250207 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Anker Innovations Limited. Cleared Aug 2025. https://www.510kdatabase.net/k250462/ 2025-08-11 monthly 0.8 https://www.510kdatabase.net/og-image/k250462-ul-uhd-clear-view-4k-camera-system-ul-fda-510k.jpg K250462 - UL UHD-Clear View 4K Camera System (UL-3Chip 4K) K250462 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Univlabs Technologies Private Limited. Cleared Aug 2025. https://www.510kdatabase.net/k251098/ 2025-08-11 monthly 0.8 https://www.510kdatabase.net/og-image/k251098-identity-revision-humeral-stems-fda-510k.jpg K251098 - Identity Revision Humeral Stems K251098 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k251125/ 2025-08-11 monthly 0.8 https://www.510kdatabase.net/og-image/k251125-magventure-tms-therapy-system-fda-510k.jpg K251125 - MagVenture TMS Therapy System K251125 is a FDA 510(k) cleared neurology medical device. Manufacturer: Tonica Elektronik A/S. Cleared Aug 2025. https://www.510kdatabase.net/k251245/ 2025-08-11 monthly 0.8 https://www.510kdatabase.net/og-image/k251245-oxyminder-pro-10310-fda-510k.jpg K251245 - OxyMinder Pro (10310) K251245 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Bio-Med Device, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k251327/ 2025-08-11 monthly 0.8 https://www.510kdatabase.net/og-image/k251327-xerf-fda-510k.jpg K251327 - XERF K251327 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lutronic Corporation. Cleared Aug 2025. https://www.510kdatabase.net/k251823/ 2025-08-11 monthly 0.8 https://www.510kdatabase.net/og-image/k251823-ue-broncho-single-use-bronchoscopes-fda-510k.jpg K251823 - UE BRONCHO Single-Use Bronchoscopes (EBS-380C) K251823 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Zhejiang UE Medical Corp.. Cleared Aug 2025. https://www.510kdatabase.net/k251862/ 2025-08-11 monthly 0.8 https://www.510kdatabase.net/og-image/k251862-external-fixation-bone-distractor-fda-510k.jpg K251862 - External Fixation Bone Distractor K251862 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paragon 28, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k251873/ 2025-08-11 monthly 0.8 https://www.510kdatabase.net/og-image/k251873-saige-dx-fda-510k.jpg K251873 - Saige-Dx K251873 is a FDA 510(k) cleared radiology medical device. Manufacturer: DeepHealth, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k252211/ 2025-08-11 monthly 0.8 https://www.510kdatabase.net/og-image/k252211-duoblade-plus-se-db1ep-db1ep-t-db1ep-h-fda-510k.jpg K252211 - Duoblade Plus SE (DB1EP, DB1EP-T, DB1EP-H, DB1EP-TH) K252211 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cnc Technologies. Cleared Aug 2025. https://www.510kdatabase.net/k243254/ 2025-08-08 monthly 0.8 https://www.510kdatabase.net/og-image/k243254-parkell-pit-and-fissure-sealant-fda-510k.jpg K243254 - Parkell Pit and Fissure Sealant K243254 is a FDA 510(k) cleared dental medical device. Manufacturer: Parkell, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k243395/ 2025-08-08 monthly 0.8 https://www.510kdatabase.net/og-image/k243395-micor-700-with-auto-ia-fda-510k.jpg K243395 - MICOR 700 with Auto I/A K243395 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Carl Zeiss Meditec Cataract Technology, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k243531/ 2025-08-08 monthly 0.8 https://www.510kdatabase.net/og-image/k243531-codman-liberts-shunt-catheter-with-fda-510k.jpg K243531 - Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology K243531 is a FDA 510(k) cleared neurology medical device. Manufacturer: Integra Lifesciences Production Corporation. Cleared Aug 2025. https://www.510kdatabase.net/k243972/ 2025-08-08 monthly 0.8 https://www.510kdatabase.net/og-image/k243972-plain-water-based-lubricant-fda-510k.jpg K243972 - Plain Water-based Lubricant K243972 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Global Protection Corp.. Cleared Aug 2025. https://www.510kdatabase.net/k250142/ 2025-08-08 monthly 0.8 https://www.510kdatabase.net/og-image/k250142-water-based-lubricant-fda-510k.jpg K250142 - Water-based Lubricant K250142 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Global Protection Corp.. Cleared Aug 2025. https://www.510kdatabase.net/k250472/ 2025-08-08 monthly 0.8 https://www.510kdatabase.net/og-image/k250472-sixfix-hexapod-fixator-and-deformity-fda-510k.jpg K250472 - SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) K250472 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Amdt Holdings, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k250540/ 2025-08-08 monthly 0.8 https://www.510kdatabase.net/og-image/k250540-saber-c-system-fda-510k.jpg K250540 - SABER-C System K250540 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Elevation Spine. Cleared Aug 2025. https://www.510kdatabase.net/k250718/ 2025-08-08 monthly 0.8 https://www.510kdatabase.net/og-image/k250718-swiftpro-system-swf-sps-fda-510k.jpg K250718 - swiftPro System (SWF-SPS) K250718 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Emblation Limited. Cleared Aug 2025. https://www.510kdatabase.net/k250817/ 2025-08-08 monthly 0.8 https://www.510kdatabase.net/og-image/k250817-coretech-compression-system-coretech-fda-510k.jpg K250817 - Coretech Compression System (Coretech RHB3003) K250817 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vive Health, LLC. Cleared Aug 2025. https://www.510kdatabase.net/k251119/ 2025-08-08 monthly 0.8 https://www.510kdatabase.net/og-image/k251119-magventure-tms-therapy-system-fda-510k.jpg K251119 - MagVenture TMS Therapy System K251119 is a FDA 510(k) cleared neurology medical device. Manufacturer: Tonica Elektronik A/S. Cleared Aug 2025. https://www.510kdatabase.net/k251226/ 2025-08-08 monthly 0.8 https://www.510kdatabase.net/og-image/k251226-aqua-medical-rf-vapor-ablation-system-fda-510k.jpg K251226 - Aqua Medical RF Vapor Ablation System K251226 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Aqua Medical, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k251713/ 2025-08-08 monthly 0.8 https://www.510kdatabase.net/og-image/k251713-bd-phoenix-automated-microbiology-fda-510k.jpg K251713 - BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL) K251713 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson and Company. Cleared Aug 2025. https://www.510kdatabase.net/k251801/ 2025-08-08 monthly 0.8 https://www.510kdatabase.net/og-image/k251801-diode-laser-device-bm091-fda-510k.jpg K251801 - Diode laser device (BM091) K251801 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Hebei Newangie Technology Co., Ltd.. Cleared Aug 2025. https://www.510kdatabase.net/k252170/ 2025-08-08 monthly 0.8 https://www.510kdatabase.net/og-image/k252170-optivu-shoulder-fda-510k.jpg K252170 - OptiVu™ Shoulder K252170 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Mr Surgical Solutions, LLC. Cleared Aug 2025. https://www.510kdatabase.net/k252176/ 2025-08-08 monthly 0.8 https://www.510kdatabase.net/og-image/k252176-single-use-video-flexible-cysto-fda-510k.jpg K252176 - Single-Use Video Flexible Cysto-Nephroscope (RP-U-C01F, RP-U-C01FS) K252176 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Guangzhou Red Pine Medical Instrument Co., Ltd.. Cleared Aug 2025. https://www.510kdatabase.net/k243021/ 2025-08-07 monthly 0.8 https://www.510kdatabase.net/og-image/k243021-longboard-revision-hip-stem-fda-510k.jpg K243021 - Longboard Revision Hip Stem K243021 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Signature Orthopaedics Pty, Ltd.. Cleared Aug 2025. https://www.510kdatabase.net/k243765/ 2025-08-07 monthly 0.8 https://www.510kdatabase.net/og-image/k243765-lumontm-system-fda-510k.jpg K243765 - LuMon(TM) System K243765 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sentec AG. Cleared Aug 2025. https://www.510kdatabase.net/k250309/ 2025-08-07 monthly 0.8 https://www.510kdatabase.net/og-image/k250309-btl-199-fda-510k.jpg K250309 - BTL-199 K250309 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: BTL Industries, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k250622/ 2025-08-07 monthly 0.8 https://www.510kdatabase.net/og-image/k250622-succession-afn-system-fda-510k.jpg K250622 - Succession™ AFN System K250622 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ortho Solutions UK , Ltd.. Cleared Aug 2025. https://www.510kdatabase.net/k250664/ 2025-08-07 monthly 0.8 https://www.510kdatabase.net/og-image/k250664-navigo-workstation-23-fprmc00039-fda-510k.jpg K250664 - Navigo Workstation 2.3 (FPRMC00039) K250664 is a FDA 510(k) cleared radiology medical device. Manufacturer: UC-CARE , Ltd.. Cleared Aug 2025. https://www.510kdatabase.net/k251247/ 2025-08-07 monthly 0.8 https://www.510kdatabase.net/og-image/k251247-gx1-radiofrequency-generator-kit-rfg-fda-510k.jpg K251247 - GX1 Radiofrequency Generator Kit (RFG-X1-120V) K251247 is a FDA 510(k) cleared neurology medical device. Manufacturer: Boston Scientific Neuromodulation Corporation. Cleared Aug 2025. https://www.510kdatabase.net/k251629/ 2025-08-07 monthly 0.8 https://www.510kdatabase.net/og-image/k251629-unid-spine-analyzer-fda-510k.jpg K251629 - UNiD™ Spine Analyzer K251629 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medicrea International S.A.S. (Medtronic). Cleared Aug 2025. https://www.510kdatabase.net/k251667/ 2025-08-07 monthly 0.8 https://www.510kdatabase.net/og-image/k251667-led-light-therapy-mask-m01-m02-m06-m07-fda-510k.jpg K251667 - LED Light Therapy Mask (M01, M02, M06, M07, M08, M09) K251667 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Liyoutong Technology Co., Ltd.. Cleared Aug 2025. https://www.510kdatabase.net/k242895/ 2025-08-06 monthly 0.8 https://www.510kdatabase.net/og-image/k242895-aevumed-phantom-suture-anchors-fda-510k.jpg K242895 - Aevumed PHANTOM Suture Anchors K242895 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aevumed, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k243552/ 2025-08-06 monthly 0.8 https://www.510kdatabase.net/og-image/k243552-codman-liberts-15-mm-evd-catheter-with-fda-510k.jpg K243552 - Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761) K243552 is a FDA 510(k) cleared neurology medical device. Manufacturer: Integra Lifesciences Production Corporation. Cleared Aug 2025. https://www.510kdatabase.net/k250124/ 2025-08-06 monthly 0.8 https://www.510kdatabase.net/og-image/k250124-viction-disposable-irrigation-and-fda-510k.jpg K250124 - Viction Disposable Irrigation and suction catheter (VC-IRA0532, VC-IRA0523, VC-IRB0532, VC-IRB0523, VC-IRC0532, VC-IRC0523, VC-IRD0532, VC-IRD0532) K250124 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Hangzhou Viction Medical Technology Co.,Ltd. Cleared Aug 2025. https://www.510kdatabase.net/k250130/ 2025-08-06 monthly 0.8 https://www.510kdatabase.net/og-image/k250130-viction-disposable-irrigation-and-fda-510k.jpg K250130 - Viction Disposable Irrigation and suction System (VC-FLA0514 K250130 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Hangzhou Viction Medical Technology Co.,Ltd. Cleared Aug 2025. https://www.510kdatabase.net/k250569/ 2025-08-06 monthly 0.8 https://www.510kdatabase.net/og-image/k250569-cardiologs-holter-platform-fda-510k.jpg K250569 - Cardiologs Holter Platform K250569 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Philips France Commercial. Cleared Aug 2025. https://www.510kdatabase.net/k251038/ 2025-08-06 monthly 0.8 https://www.510kdatabase.net/og-image/k251038-digital-radiographic-imaging-fda-510k.jpg K251038 - Digital Radiographic Imaging Acquisition Software - DR (RiasDR) K251038 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shen Zhen Cambridge-Hit Co., Ltd.. Cleared Aug 2025. https://www.510kdatabase.net/k251120/ 2025-08-06 monthly 0.8 https://www.510kdatabase.net/og-image/k251120-microlife-upper-arm-automatic-digital-fda-510k.jpg K251120 - Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP Progress (BP3T01-1B) K251120 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Microlife Corporation. Cleared Aug 2025. https://www.510kdatabase.net/k251432/ 2025-08-06 monthly 0.8 https://www.510kdatabase.net/og-image/k251432-olo-fda-510k.jpg K251432 - Olo K251432 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: El.En S.P.A.. Cleared Aug 2025. https://www.510kdatabase.net/k251854/ 2025-08-06 monthly 0.8 https://www.510kdatabase.net/og-image/k251854-steadiset-infusion-set-fda-510k.jpg K251854 - SteadiSet infusion set K251854 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Tandem Diabetes Care. Cleared Aug 2025. https://www.510kdatabase.net/k252239/ 2025-08-06 monthly 0.8 https://www.510kdatabase.net/og-image/k252239-invision-3t-recharge-operating-suite-fda-510k.jpg K252239 - InVision™ 3T Recharge Operating Suite K252239 is a FDA 510(k) cleared radiology medical device. Manufacturer: Imris Imaging, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k252326/ 2025-08-06 monthly 0.8 https://www.510kdatabase.net/og-image/k252326-interspace-gv-hip-spacer-fda-510k.jpg K252326 - InterSpace GV Hip Spacer K252326 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tecres S.P.A.. Cleared Aug 2025. https://www.510kdatabase.net/k244016/ 2025-08-05 monthly 0.8 https://www.510kdatabase.net/og-image/k244016-ipetcertum-v10-fda-510k.jpg K244016 - iPETcertum (v1.0) K244016 is a FDA 510(k) cleared radiology medical device. Manufacturer: Claritas Healthtech Pte, Ltd.. Cleared Aug 2025. https://www.510kdatabase.net/k250246/ 2025-08-05 monthly 0.8 https://www.510kdatabase.net/og-image/k250246-umr-jupiter-fda-510k.jpg K250246 - uMR Jupiter K250246 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Aug 2025. https://www.510kdatabase.net/k250434/ 2025-08-05 monthly 0.8 https://www.510kdatabase.net/og-image/k250434-trophon2-fda-510k.jpg K250434 - trophon2 K250434 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Nanosonics. Cleared Aug 2025. https://www.510kdatabase.net/k250934/ 2025-08-05 monthly 0.8 https://www.510kdatabase.net/og-image/k250934-respiree-cardio-respiratory-monitor-fda-510k.jpg K250934 - Respiree Cardio- Respiratory Monitor System K250934 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respiree Pte, Ltd.. Cleared Aug 2025. https://www.510kdatabase.net/k251411/ 2025-08-05 monthly 0.8 https://www.510kdatabase.net/og-image/k251411-chemfort-female-luer-lock-adaptor-fda-510k.jpg K251411 - Chemfort Female Luer Lock Adaptor K251411 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Simplivia Healthcare , Ltd.. Cleared Aug 2025. https://www.510kdatabase.net/k252113/ 2025-08-05 monthly 0.8 https://www.510kdatabase.net/og-image/k252113-prado-lumbar-interbody-fusion-system-fda-510k.jpg K252113 - PRADO™ Lumbar Interbody Fusion System K252113 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Bethesda Medical Devices. Cleared Aug 2025. https://www.510kdatabase.net/k252141/ 2025-08-05 monthly 0.8 https://www.510kdatabase.net/og-image/k252141-altivate-reverse-glenoid-fda-510k.jpg K252141 - AltiVate Reverse® Glenoid K252141 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Encore Medical, L.P.. Cleared Aug 2025. https://www.510kdatabase.net/k250950/ 2025-08-04 monthly 0.8 https://www.510kdatabase.net/og-image/k250950-cutiva-topical-skin-adhesive-rm1700-fda-510k.jpg K250950 - CUTIVA™ Topical Skin Adhesive (RM1700) K250950 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Okapi Medical, LLC Dba Resivant Medical. Cleared Aug 2025. https://www.510kdatabase.net/k251087/ 2025-08-04 monthly 0.8 https://www.510kdatabase.net/og-image/k251087-blood-volume-analyzer-200-fda-510k.jpg K251087 - Blood Volume Analyzer (200) K251087 is a FDA 510(k) cleared hematology medical device. Manufacturer: Daxor Corporation. Cleared Aug 2025. https://www.510kdatabase.net/k251113/ 2025-08-04 monthly 0.8 https://www.510kdatabase.net/og-image/k251113-ihealth-compare-wireless-blood-fda-510k.jpg K251113 - iHealth Compare Wireless Blood Pressure Monitor(BP-300C) K251113 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Andon Health Co, Ltd.. Cleared Aug 2025. https://www.510kdatabase.net/k251122/ 2025-08-04 monthly 0.8 https://www.510kdatabase.net/og-image/k251122-terragene-bionova-bt20-biological-fda-510k.jpg K251122 - Terragene® Bionova® BT20 Biological Indicator K251122 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terragene. Cleared Aug 2025. https://www.510kdatabase.net/k251223/ 2025-08-04 monthly 0.8 https://www.510kdatabase.net/og-image/k251223-hnx-p1-hnx-pb-fda-510k.jpg K251223 - HnX-P1, HnX-PB K251223 is a FDA 510(k) cleared radiology medical device. Manufacturer: H&abyz Co., Ltd.. Cleared Aug 2025. https://www.510kdatabase.net/k251762/ 2025-08-04 monthly 0.8 https://www.510kdatabase.net/og-image/k251762-quantum-perfusion-centrifugal-blood-fda-510k.jpg K251762 - Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated Sensors (CP20V-NG) K251762 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Spectrum Medical S.R.L.. Cleared Aug 2025. https://www.510kdatabase.net/k243427/ 2025-08-01 monthly 0.8 https://www.510kdatabase.net/og-image/k243427-quicksleeper-5-fda-510k.jpg K243427 - QuickSleeper 5 K243427 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentalhitec. Cleared Aug 2025. https://www.510kdatabase.net/k243448/ 2025-08-01 monthly 0.8 https://www.510kdatabase.net/og-image/k243448-equinoxe-shoulder-system-fda-510k.jpg K243448 - Equinoxe® Shoulder System K243448 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k243458/ 2025-08-01 monthly 0.8 https://www.510kdatabase.net/og-image/k243458-hydropicc-4fr-single-lumen-marked-fda-510k.jpg K243458 - HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301) K243458 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Access Vascular, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k243462/ 2025-08-01 monthly 0.8 https://www.510kdatabase.net/og-image/k243462-diazyme-colorimetric-lithium-assay-fda-510k.jpg K243462 - Diazyme Colorimetric Lithium Assay K243462 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diazyme Laboratories, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k243483/ 2025-08-01 monthly 0.8 https://www.510kdatabase.net/og-image/k243483-access-hstni-fda-510k.jpg K243483 - Access hsTnI K243483 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k243496/ 2025-08-01 monthly 0.8 https://www.510kdatabase.net/og-image/k243496-mycomeia-aspergillus-assay-fda-510k.jpg K243496 - MycoMEIA Aspergillus Assay K243496 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Pearl Diagnostics, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k243841/ 2025-08-01 monthly 0.8 https://www.510kdatabase.net/og-image/k243841-sparta-infusion-set-for-insulin-fda-510k.jpg K243841 - Sparta Infusion Set for Insulin K243841 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Deka Research and Development. Cleared Aug 2025. https://www.510kdatabase.net/k250315/ 2025-08-01 monthly 0.8 https://www.510kdatabase.net/og-image/k250315-ronavis-fx-fx-001-fda-510k.jpg K250315 - RONAVIS – FX (FX-001) K250315 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: AIRS, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k250381/ 2025-08-01 monthly 0.8 https://www.510kdatabase.net/og-image/k250381-deepsight-needlevue-lc1-ultrasound-fda-510k.jpg K250381 - Deepsight NeedleVue LC1 Ultrasound System K250381 is a FDA 510(k) cleared radiology medical device. Manufacturer: DeepSight Technology, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k250495/ 2025-08-01 monthly 0.8 https://www.510kdatabase.net/og-image/k250495-mini-vp1-pl67f-fda-510k.jpg K250495 - MINI VP1 (PL67_F) K250495 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Avizor S.A.. Cleared Aug 2025. https://www.510kdatabase.net/k250508/ 2025-08-01 monthly 0.8 https://www.510kdatabase.net/og-image/k250508-ak-98-dialysis-machine-955607-fda-510k.jpg K250508 - AK 98 Dialysis Machine (955607) K250508 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Vantive US Healthcare, LLC. Cleared Aug 2025. https://www.510kdatabase.net/k250541/ 2025-08-01 monthly 0.8 https://www.510kdatabase.net/og-image/k250541-self-forming-magnet-flexagon-plus-otoloc-fda-510k.jpg K250541 - Self-Forming Magnet (Flexagon Plus OTOLoc) K250541 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: GI Windows, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k250790/ 2025-08-01 monthly 0.8 https://www.510kdatabase.net/og-image/k250790-innovision-dxii-fda-510k.jpg K250790 - INNOVISION-DXII K250790 is a FDA 510(k) cleared radiology medical device. Manufacturer: Dk Medical Systems Co., Ltd.. Cleared Aug 2025. https://www.510kdatabase.net/k250941/ 2025-08-01 monthly 0.8 https://www.510kdatabase.net/og-image/k250941-revolution-vibe-fda-510k.jpg K250941 - Revolution Vibe K250941 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems, LLC. Cleared Aug 2025. https://www.510kdatabase.net/k251252/ 2025-08-01 monthly 0.8 https://www.510kdatabase.net/og-image/k251252-nobilcam-impak-disc-fda-510k.jpg K251252 - NOBILCAM IMPAK Disc K251252 is a FDA 510(k) cleared dental medical device. Manufacturer: Shandong Huge Dental Material Corporation. Cleared Aug 2025. https://www.510kdatabase.net/k251652/ 2025-08-01 monthly 0.8 https://www.510kdatabase.net/og-image/k251652-strauss-surgical-cystoscopes-fda-510k.jpg K251652 - Strauss Surgical Cystoscopes & Hysteroscopes (STS-2040-302ASA HD-endoscope, STS-2040-302AA HD-endoscope, STS-2040-302BA HD-endoscope, STS-2040-302BSA HD-endoscope, STS-2040-302ESA HD-endoscope, STS-2040-302CA HD-endoscope, STS-2029-302AA HD-endoscope, STS-2029-302BA HD-endoscope, STS-2040-298DSA-RWF-endoscope, STS-2040-298ASA-RWF-endoscope, STS-2040-300GSA-RWF-endoscope, STS-2040-303CA-RWF-endoscope, STS-2040-280ASA-OLY-endoscope, STS-2040-280ESA-OLY-endoscope, STS-2040-283BSA-OLY-endo K251652 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: American Medical Endoscopy, Inc.. Cleared Aug 2025. https://www.510kdatabase.net/k251707/ 2025-08-01 monthly 0.8 https://www.510kdatabase.net/og-image/k251707-ipl-hair-removal-device-hct-1208hct-fda-510k.jpg K251707 - IPL Hair Removal Device (HCT-1208/HCT-1208B/HCT-1208L) K251707 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Huachuangtong Industrial Co., Ltd.. Cleared Aug 2025. https://www.510kdatabase.net/k252094/ 2025-08-01 monthly 0.8 https://www.510kdatabase.net/og-image/k252094-ezsure-empty-fluid-container-fda-510k.jpg K252094 - eZSURE™ Empty Fluid Container K252094 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Epic Medical Pte. , Ltd.. Cleared Aug 2025. https://www.510kdatabase.net/k241461/ 2025-07-31 monthly 0.8 https://www.510kdatabase.net/og-image/k241461-mpact-constrained-liner-fda-510k.jpg K241461 - Mpact Constrained Liner K241461 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Jul 2025. https://www.510kdatabase.net/k242728/ 2025-07-31 monthly 0.8 https://www.510kdatabase.net/og-image/k242728-benevision-central-monitoring-system-fda-510k.jpg K242728 - BeneVision Central Monitoring System K242728 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k243341/ 2025-07-31 monthly 0.8 https://www.510kdatabase.net/og-image/k243341-genius-ai-detection-20-fda-510k.jpg K243341 - Genius AI Detection 2.0 K243341 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hologic, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k243455/ 2025-07-31 monthly 0.8 https://www.510kdatabase.net/og-image/k243455-cobas-respiratory-4-flex-for-use-on-fda-510k.jpg K243455 - cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems K243455 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Molecular Systems, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k243571/ 2025-07-31 monthly 0.8 https://www.510kdatabase.net/og-image/k243571-trabecular-metal-acetabular-revision-fda-510k.jpg K243571 - Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained Liners K243571 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer Biomet. Cleared Jul 2025. https://www.510kdatabase.net/k243656/ 2025-07-31 monthly 0.8 https://www.510kdatabase.net/og-image/k243656-u2-total-knee-system-pf-patella-fda-510k.jpg K243656 - U2 Total Knee System – PF+ Patella K243656 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: United Orthopedic Corporation. Cleared Jul 2025. https://www.510kdatabase.net/k244060/ 2025-07-31 monthly 0.8 https://www.510kdatabase.net/og-image/k244060-eco2-3d-fda-510k.jpg K244060 - eCO2 3D K244060 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lutronic Corporation. Cleared Jul 2025. https://www.510kdatabase.net/k250477/ 2025-07-31 monthly 0.8 https://www.510kdatabase.net/og-image/k250477-nextartm-spine-fda-510k.jpg K250477 - NextAR(TM) Spine K250477 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Jul 2025. https://www.510kdatabase.net/k250597/ 2025-07-31 monthly 0.8 https://www.510kdatabase.net/og-image/k250597-remex-xcam6-fda-510k.jpg K250597 - REMEX Xcam6 K250597 is a FDA 510(k) cleared radiology medical device. Manufacturer: Remedi, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k250738/ 2025-07-31 monthly 0.8 https://www.510kdatabase.net/og-image/k250738-ysio-xpree-fda-510k.jpg K250738 - YSIO X.pree K250738 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions. Cleared Jul 2025. https://www.510kdatabase.net/k250843/ 2025-07-31 monthly 0.8 https://www.510kdatabase.net/og-image/k250843-wearable-breast-pump-model-fs12a-fda-510k.jpg K250843 - Wearable Breast Pump (Model FS12A) K250843 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shenzhen TPH Technology Co., Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k251561/ 2025-07-31 monthly 0.8 https://www.510kdatabase.net/og-image/k251561-biograph-trinion-fda-510k.jpg K251561 - Biograph Trinion K251561 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k251574/ 2025-07-31 monthly 0.8 https://www.510kdatabase.net/og-image/k251574-sleep-watch-fda-510k.jpg K251574 - Sleep Watch K251574 is a FDA 510(k) cleared neurology medical device. Manufacturer: Ambulatory Monitoring, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/den240068/ 2025-07-31 monthly 0.8 https://www.510kdatabase.net/og-image/den240068-arteraai-prostate-fda-510k.jpg DEN240068 - ArteraAI Prostate DEN240068 is a FDA 510(k) cleared pathology medical device. Manufacturer: Artera, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k241990/ 2025-07-30 monthly 0.8 https://www.510kdatabase.net/og-image/k241990-spinesite-endoscope-system-fda-510k.jpg K241990 - SpineSite Endoscope System K241990 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Hydrocision, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k242855/ 2025-07-30 monthly 0.8 https://www.510kdatabase.net/og-image/k242855-p-con-polymacon-soft-hydrophilic-fda-510k.jpg K242855 - P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) K242855 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: E.O.S Co., Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k243534/ 2025-07-30 monthly 0.8 https://www.510kdatabase.net/og-image/k243534-micro-catheter-fda-510k.jpg K243534 - Micro Catheter K243534 is a FDA 510(k) cleared neurology medical device. Manufacturer: Suzhou Zenith Vascular SciTech Limited. Cleared Jul 2025. https://www.510kdatabase.net/k243919/ 2025-07-30 monthly 0.8 https://www.510kdatabase.net/og-image/k243919-voxel-dosimetry-00859873006226-fda-510k.jpg K243919 - Voxel Dosimetry (00859873006226) K243919 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hermes Medical Solutions AB. Cleared Jul 2025. https://www.510kdatabase.net/k244007/ 2025-07-30 monthly 0.8 https://www.510kdatabase.net/og-image/k244007-artevu-fda-510k.jpg K244007 - ArteVu K244007 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cardio Ring Technologies, Inc. Taiwan Branch. Cleared Jul 2025. https://www.510kdatabase.net/k250127/ 2025-07-30 monthly 0.8 https://www.510kdatabase.net/og-image/k250127-tsk-syringe-fda-510k.jpg K250127 - TSK Syringe K250127 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Tsk Laboratory, Japan. Cleared Jul 2025. https://www.510kdatabase.net/k250724/ 2025-07-30 monthly 0.8 https://www.510kdatabase.net/og-image/k250724-intraosseous-infusion-needles-fda-510k.jpg K250724 - Intraosseous Infusion Needles K250724 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Spectrum Vascular. Cleared Jul 2025. https://www.510kdatabase.net/k251060/ 2025-07-30 monthly 0.8 https://www.510kdatabase.net/og-image/k251060-corus-navigation-system-gx-fda-510k.jpg K251060 - CORUS™ Navigation System-GX K251060 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Providence Medical Technology, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k251076/ 2025-07-30 monthly 0.8 https://www.510kdatabase.net/og-image/k251076-diode-laser-hair-removal-machine-fda-510k.jpg K251076 - Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E) K251076 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k251234/ 2025-07-30 monthly 0.8 https://www.510kdatabase.net/og-image/k251234-ensite-x-ep-system-fda-510k.jpg K251234 - EnSite™ X EP System K251234 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared Jul 2025. https://www.510kdatabase.net/k251319/ 2025-07-30 monthly 0.8 https://www.510kdatabase.net/og-image/k251319-sterile-nitrile-powder-free-fda-510k.jpg K251319 - Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) K251319 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hartalega NGC Sdn. Bhd.. Cleared Jul 2025. https://www.510kdatabase.net/k251361/ 2025-07-30 monthly 0.8 https://www.510kdatabase.net/og-image/k251361-tyber-medical-distal-radius-plating-fda-510k.jpg K251361 - Tyber Medical Distal Radius Plating System K251361 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tyber Medical, LLC. Cleared Jul 2025. https://www.510kdatabase.net/k251706/ 2025-07-30 monthly 0.8 https://www.510kdatabase.net/og-image/k251706-tens-and-ems-unit-fda-510k.jpg K251706 - TENS and EMS Unit K251706 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Changsha Anxiang Medical Technology Co., Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k251735/ 2025-07-30 monthly 0.8 https://www.510kdatabase.net/og-image/k251735-stabilis-sa-cervical-stand-alone-fda-510k.jpg K251735 - Stabilis SA Cervical Stand-Alone System (Various PNs) K251735 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Acuity Surgical Devices, LLC. Cleared Jul 2025. https://www.510kdatabase.net/k252032/ 2025-07-30 monthly 0.8 https://www.510kdatabase.net/og-image/k252032-t65-9016e061--fda-510k.jpg K252032 - T65 (9016E061-) K252032 is a FDA 510(k) cleared neurology medical device. Manufacturer: Tonica Elektronik A/S. Cleared Jul 2025. https://www.510kdatabase.net/k252144/ 2025-07-30 monthly 0.8 https://www.510kdatabase.net/og-image/k252144-iconix-speed-anchor-fda-510k.jpg K252144 - Iconix Speed Anchor K252144 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Riverpoint Medical. Cleared Jul 2025. https://www.510kdatabase.net/k243407/ 2025-07-29 monthly 0.8 https://www.510kdatabase.net/og-image/k243407-forcyte-autograft-harvest-kit-fda-510k.jpg K243407 - Forcyte Autograft Harvest Kit K243407 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Forcyte Medical, LLC. Cleared Jul 2025. https://www.510kdatabase.net/k243473/ 2025-07-29 monthly 0.8 https://www.510kdatabase.net/og-image/k243473-prorad-atlas-ultraportable-fda-510k.jpg K243473 - PRORAD ATLAS ULTRAPORTABLE K243473 is a FDA 510(k) cleared radiology medical device. Manufacturer: Prognosys Medical Systems Private Limited. Cleared Jul 2025. https://www.510kdatabase.net/k250179/ 2025-07-29 monthly 0.8 https://www.510kdatabase.net/og-image/k250179-patient-monitor-cx10-cx12-cx15-ux10-fda-510k.jpg K250179 - Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) K250179 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edan Instruments, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k250356/ 2025-07-29 monthly 0.8 https://www.510kdatabase.net/og-image/k250356-mome-arc-wireless-ambulatory-ecg-fda-510k.jpg K250356 - MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) K250356 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Infobionic, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k250442/ 2025-07-29 monthly 0.8 https://www.510kdatabase.net/og-image/k250442-da-vinci-surgical-system-is5000-fda-510k.jpg K250442 - da Vinci Surgical System, IS5000 K250442 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k250647/ 2025-07-29 monthly 0.8 https://www.510kdatabase.net/og-image/k250647-simmetry-system-fda-510k.jpg K250647 - SImmetry+ System K250647 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Sivantage. Cleared Jul 2025. https://www.510kdatabase.net/k251350/ 2025-07-29 monthly 0.8 https://www.510kdatabase.net/og-image/k251350-bd-plastipak-syringe-fda-510k.jpg K251350 - BD Plastipak™ Syringe K251350 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson and Company. Cleared Jul 2025. https://www.510kdatabase.net/k251364/ 2025-07-29 monthly 0.8 https://www.510kdatabase.net/og-image/k251364-sleepiz-one-25-fda-510k.jpg K251364 - Sleepiz One+ (2.5) K251364 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sleepiz AG. Cleared Jul 2025. https://www.510kdatabase.net/k251523/ 2025-07-29 monthly 0.8 https://www.510kdatabase.net/og-image/k251523-cios-spin-fda-510k.jpg K251523 - Cios Spin K251523 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k251664/ 2025-07-29 monthly 0.8 https://www.510kdatabase.net/og-image/k251664-single-use-aspiration-needle-na-201sx-fda-510k.jpg K251664 - Single Use Aspiration Needle (NA-201SX-4021) K251664 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Olympus Medical Systems Corporation. Cleared Jul 2025. https://www.510kdatabase.net/k241183/ 2025-07-28 monthly 0.8 https://www.510kdatabase.net/og-image/k241183-iso-abutment-fda-510k.jpg K241183 - ISO Abutment K241183 is a FDA 510(k) cleared dental medical device. Manufacturer: Seum Medi Co., Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k243489/ 2025-07-28 monthly 0.8 https://www.510kdatabase.net/og-image/k243489-alinity-m-ebv-09n43-095-fda-510k.jpg K243489 - Alinity m EBV (09N43-095) K243489 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Molecular, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k250652/ 2025-07-28 monthly 0.8 https://www.510kdatabase.net/og-image/k250652-ecg-ai-low-ejection-fraction-lef-12-fda-510k.jpg K250652 - ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) K250652 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Anumana, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k251061/ 2025-07-28 monthly 0.8 https://www.510kdatabase.net/og-image/k251061-naeotom-alphapeaknaeotom-alpha-fda-510k.jpg K251061 - NAEOTOM Alpha.Peak/NAEOTOM Alpha K251061 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k251187/ 2025-07-28 monthly 0.8 https://www.510kdatabase.net/og-image/k251187-3-in-1-tens-unit-tc1241-tc2241-ts1241-fda-510k.jpg K251187 - 3 in 1 TENS UNIT (TC1241, TC2241, TS1241) K251187 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Changsha Anxiang Medical Technology Co., Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k251220/ 2025-07-28 monthly 0.8 https://www.510kdatabase.net/og-image/k251220-nuventus-nvc-prosthetic-components-fda-510k.jpg K251220 - NUVENTUS NV.C™ Prosthetic Components K251220 is a FDA 510(k) cleared dental medical device. Manufacturer: Infinitum Eta, Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k251636/ 2025-07-28 monthly 0.8 https://www.510kdatabase.net/og-image/k251636-spectrum-iq-infusion-system-with-dose-fda-510k.jpg K251636 - Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) K251636 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corporation. Cleared Jul 2025. https://www.510kdatabase.net/k251640/ 2025-07-28 monthly 0.8 https://www.510kdatabase.net/og-image/k251640-sigma-spectrum-infusion-pump-with-fda-510k.jpg K251640 - SIGMA Spectrum Infusion Pump with Master Drug Library K251640 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corporation. Cleared Jul 2025. https://www.510kdatabase.net/k243244/ 2025-07-25 monthly 0.8 https://www.510kdatabase.net/og-image/k243244-heated-breathing-tube-fda-510k.jpg K243244 - Heated Breathing Tube K243244 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Guangdong Eda Technology Co., Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k243403/ 2025-07-25 monthly 0.8 https://www.510kdatabase.net/og-image/k243403-bd-nexiva-closed-iv-catheter-system-fda-510k.jpg K243403 - BD Nexiva™ Closed IV Catheter System K243403 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton Dickinson Infusion Therapy Systems, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k250232/ 2025-07-25 monthly 0.8 https://www.510kdatabase.net/og-image/k250232-vathin-video-bronchoscope-system-fda-510k.jpg K250232 - Vathin® Video Bronchoscope System K250232 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Hunan Vathin Medical Instrument Co., Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k250244/ 2025-07-25 monthly 0.8 https://www.510kdatabase.net/og-image/k250244-compression-therapy-device-lgt-2210ds-fda-510k.jpg K250244 - Compression Therapy Device (LGT-2210DS) K250244 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Guangzhou Longest Medical Technology Co., Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k250334/ 2025-07-25 monthly 0.8 https://www.510kdatabase.net/og-image/k250334-fusion-craniofacial-implant-fda-510k.jpg K250334 - Fusion Craniofacial Implant K250334 is a FDA 510(k) cleared neurology medical device. Manufacturer: Kelyniam Global, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k250552/ 2025-07-25 monthly 0.8 https://www.510kdatabase.net/og-image/k250552-hi-torque-command-14-st-guide-wire-and-fda-510k.jpg K250552 - Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire K250552 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared Jul 2025. https://www.510kdatabase.net/k250859/ 2025-07-25 monthly 0.8 https://www.510kdatabase.net/og-image/k250859-transform-mccarthy-mitral-annuloplasty-fda-510k.jpg K250859 - TransForm McCarthy Mitral Annuloplasty Ring (TF) K250859 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Genesee Biomedical, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k250970/ 2025-07-25 monthly 0.8 https://www.510kdatabase.net/og-image/k250970-marie-fda-510k.jpg K250970 - Marie K250970 is a FDA 510(k) cleared radiology medical device. Manufacturer: Leo Cancer Care. Cleared Jul 2025. https://www.510kdatabase.net/k250989/ 2025-07-25 monthly 0.8 https://www.510kdatabase.net/og-image/k250989-stryker-and-serf-hip-devices-fda-510k.jpg K250989 - Stryker and Serf hip devices K250989 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp., Dba Stryker Orthopaedics. Cleared Jul 2025. https://www.510kdatabase.net/k251322/ 2025-07-25 monthly 0.8 https://www.510kdatabase.net/og-image/k251322-venue-fda-510k.jpg K251322 - Venue K251322 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared Jul 2025. https://www.510kdatabase.net/k251339/ 2025-07-25 monthly 0.8 https://www.510kdatabase.net/og-image/k251339-medical-diode-laser-hair-removal-fda-510k.jpg K251339 - Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04) K251339 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Zhengzhou PZ Laser Slim Technology Co., Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k251620/ 2025-07-25 monthly 0.8 https://www.510kdatabase.net/og-image/k251620-alps-proximal-humerus-plating-system-fda-510k.jpg K251620 - A.L.P.S. Proximal Humerus Plating System K251620 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer Biomet. Cleared Jul 2025. https://www.510kdatabase.net/k251665/ 2025-07-25 monthly 0.8 https://www.510kdatabase.net/og-image/k251665-triathlon-hinge-knee-system-fda-510k.jpg K251665 - Triathlon® Hinge Knee System K251665 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp., Dba Stryker Orthopaedics. Cleared Jul 2025. https://www.510kdatabase.net/k252033/ 2025-07-25 monthly 0.8 https://www.510kdatabase.net/og-image/k252033-profoject-disposable-syringe-profoject-fda-510k.jpg K252033 - Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle K252033 is a FDA 510(k) cleared general hospital medical device. Manufacturer: CMT Health PTE., Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k252215/ 2025-07-25 monthly 0.8 https://www.510kdatabase.net/og-image/k252215-inbellamax-system-fda-510k.jpg K252215 - InbellaMAX System K252215 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Inbella Medical , Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k243392/ 2025-07-24 monthly 0.8 https://www.510kdatabase.net/og-image/k243392-infusomat-space-volumetric-infusion-fda-510k.jpg K243392 - Infusomat® Space Volumetric Infusion Pump Administration Sets K243392 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k243711/ 2025-07-24 monthly 0.8 https://www.510kdatabase.net/og-image/k243711-confocal-microprobe-imaging-system-fda-510k.jpg K243711 - Confocal Microprobe Imaging System (BrightP980) K243711 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wuxi Hisky Medical Technologies Co., Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k250284/ 2025-07-24 monthly 0.8 https://www.510kdatabase.net/og-image/k250284-tsk-select-needle-fda-510k.jpg K250284 - TSK SELECT™ Needle K250284 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Tsk Laboratory, Japan. Cleared Jul 2025. https://www.510kdatabase.net/k250322/ 2025-07-24 monthly 0.8 https://www.510kdatabase.net/og-image/k250322-respond-oc-conserving-regulator-130-0800-fda-510k.jpg K250322 - Respond OC Conserving Regulator (130-0800) K250322 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Responsive Respiratory. Cleared Jul 2025. https://www.510kdatabase.net/k251297/ 2025-07-24 monthly 0.8 https://www.510kdatabase.net/og-image/k251297-mis-lynx-conical-connection-implant-fda-510k.jpg K251297 - MIS LYNX Conical Connection Implant System K251297 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k251455/ 2025-07-24 monthly 0.8 https://www.510kdatabase.net/og-image/k251455-epiq-series-diagnostic-ultrasound-system-fda-510k.jpg K251455 - EPIQ Series Diagnostic Ultrasound System K251455 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Ultrasound, LLC. Cleared Jul 2025. https://www.510kdatabase.net/k251618/ 2025-07-24 monthly 0.8 https://www.510kdatabase.net/og-image/k251618-moto-partial-knee-system-extension-fda-510k.jpg K251618 - MOTO Partial Knee System Extension K251618 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Jul 2025. https://www.510kdatabase.net/k251955/ 2025-07-24 monthly 0.8 https://www.510kdatabase.net/og-image/k251955-onflex-mesh-fda-510k.jpg K251955 - Onflex™ Mesh K251955 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Davol Inc., Subsidiary of C. R. Bard, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k251968/ 2025-07-24 monthly 0.8 https://www.510kdatabase.net/og-image/k251968-hemosil-fibrinogen-c-fda-510k.jpg K251968 - HemosIL Fibrinogen-C K251968 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory (IL) Co.. Cleared Jul 2025. https://www.510kdatabase.net/k251984/ 2025-07-24 monthly 0.8 https://www.510kdatabase.net/og-image/k251984-ice-cooling-ipl-hair-removal-device-fda-510k.jpg K251984 - Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU) K251984 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Ulike Smart Electronics Co., Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k252010/ 2025-07-24 monthly 0.8 https://www.510kdatabase.net/og-image/k252010-spy-laparoscope-fda-510k.jpg K252010 - SPY Laparoscope K252010 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker Endoscopy. Cleared Jul 2025. https://www.510kdatabase.net/k252056/ 2025-07-24 monthly 0.8 https://www.510kdatabase.net/og-image/k252056-isolator-synergy-encompass-clamp-and-fda-510k.jpg K252056 - Isolator® Synergy™ EnCompass Clamp and Guide system (OLH, OSH, GPM100) K252056 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: AtriCure, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k242615/ 2025-07-23 monthly 0.8 https://www.510kdatabase.net/og-image/k242615-intermittent-pressure-compression-fda-510k.jpg K242615 - Intermittent pressure compression system (Compression Pump PT1005A K242615 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Xiamen Taotao Technology Co., Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k243373/ 2025-07-23 monthly 0.8 https://www.510kdatabase.net/og-image/k243373-embryo-transfer-catheter-etc-fda-510k.jpg K243373 - Embryo Transfer Catheter (ETC) Assortment: EmbryoCath Embryo Transfer Catheter - Pre-curved 230 mm (REF 17500) K243373 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Vitrolife Sweden AB. Cleared Jul 2025. https://www.510kdatabase.net/k243681/ 2025-07-23 monthly 0.8 https://www.510kdatabase.net/og-image/k243681-neuro-insight-v10-fda-510k.jpg K243681 - Neuro Insight V1.0 K243681 is a FDA 510(k) cleared radiology medical device. Manufacturer: Olea Medical S.A.S.. Cleared Jul 2025. https://www.510kdatabase.net/k243781/ 2025-07-23 monthly 0.8 https://www.510kdatabase.net/og-image/k243781-hemosphere-advanced-monitor-hem1-fda-510k.jpg K243781 - HemoSphere Advanced Monitor (HEM1) K243781 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences. Cleared Jul 2025. https://www.510kdatabase.net/k250280/ 2025-07-23 monthly 0.8 https://www.510kdatabase.net/og-image/k250280-sd-tl-implant-system-fda-510k.jpg K250280 - SD TL Implant System K250280 is a FDA 510(k) cleared dental medical device. Manufacturer: Arum Dentistry Co., Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k250590/ 2025-07-23 monthly 0.8 https://www.510kdatabase.net/og-image/k250590-magic-sweep-ep-mapping-catheter-fda-510k.jpg K250590 - MAGiC Sweep™ EP Mapping Catheter K250590 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Stereotaxis, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k250716/ 2025-07-23 monthly 0.8 https://www.510kdatabase.net/og-image/k250716-image-one-fda-510k.jpg K250716 - IMAGE ONE K250716 is a FDA 510(k) cleared radiology medical device. Manufacturer: Infomed Software, S.L.. Cleared Jul 2025. https://www.510kdatabase.net/k251073/ 2025-07-23 monthly 0.8 https://www.510kdatabase.net/og-image/k251073-innovasis-navigation-instruments-fda-510k.jpg K251073 - Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the Excella G-E Navigation Instruments) K251073 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Innovasis, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k251213/ 2025-07-23 monthly 0.8 https://www.510kdatabase.net/og-image/k251213-da-vinci-surgical-system-is5000-fda-510k.jpg K251213 - Da Vinci Surgical System (IS5000) K251213 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k251265/ 2025-07-23 monthly 0.8 https://www.510kdatabase.net/og-image/k251265-resilience-fully-covered-esophageal-fda-510k.jpg K251265 - Resilience Fully Covered Esophageal Stent System K251265 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k251280/ 2025-07-23 monthly 0.8 https://www.510kdatabase.net/og-image/k251280-dess-dental-implants-fda-510k.jpg K251280 - DESS® Dental Implants K251280 is a FDA 510(k) cleared dental medical device. Manufacturer: Terrats Medical SL. Cleared Jul 2025. https://www.510kdatabase.net/k251748/ 2025-07-23 monthly 0.8 https://www.510kdatabase.net/og-image/k251748-mammostar-biopsy-site-identifier-fda-510k.jpg K251748 - MammoSTAR Biopsy Site Identifier K251748 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Carbon Medical Technologies, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k243367/ 2025-07-22 monthly 0.8 https://www.510kdatabase.net/og-image/k243367-minnesota-medical-technologies-fecal-fda-510k.jpg K243367 - Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle) K243367 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Minnesota Medical Technologies. Cleared Jul 2025. https://www.510kdatabase.net/k243415/ 2025-07-22 monthly 0.8 https://www.510kdatabase.net/og-image/k243415-granudacyn-wound-irrigation-solution-fda-510k.jpg K243415 - Granudacyn® Wound Irrigation Solution K243415 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: P.G.F. Industry Solutions GmbH. Cleared Jul 2025. https://www.510kdatabase.net/k243425/ 2025-07-22 monthly 0.8 https://www.510kdatabase.net/og-image/k243425-guided-das-surgical-kit-fda-510k.jpg K243425 - Guided DAS Surgical Kit K243425 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Talladium Espa?a, SL. Cleared Jul 2025. https://www.510kdatabase.net/k243432/ 2025-07-22 monthly 0.8 https://www.510kdatabase.net/og-image/k243432-vascular-navigation-pad-20-fda-510k.jpg K243432 - Vascular Navigation PAD 2.0 K243432 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab AG. Cleared Jul 2025. https://www.510kdatabase.net/k243566/ 2025-07-22 monthly 0.8 https://www.510kdatabase.net/og-image/k243566-cardiotag-fda-510k.jpg K243566 - CardioTag™ K243566 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cardiosense, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k244018/ 2025-07-22 monthly 0.8 https://www.510kdatabase.net/og-image/k244018-disposable-biopsy-needle-fda-510k.jpg K244018 - Disposable Biopsy Needle K244018 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Zhejiang Curaway Medical Technology Co., Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k250211/ 2025-07-22 monthly 0.8 https://www.510kdatabase.net/og-image/k250211-yushan-x-ray-flat-panel-detector-fda-510k.jpg K250211 - Yushan X-Ray Flat Panel Detector K250211 is a FDA 510(k) cleared radiology medical device. Manufacturer: Innocare Optoelectronics Corp.. Cleared Jul 2025. https://www.510kdatabase.net/k250686/ 2025-07-22 monthly 0.8 https://www.510kdatabase.net/og-image/k250686-gyricalc-version-100-fda-510k.jpg K250686 - GyriCalc (Version 1.0.0) K250686 is a FDA 510(k) cleared radiology medical device. Manufacturer: Neurospectrum Insights Corp.. Cleared Jul 2025. https://www.510kdatabase.net/k250901/ 2025-07-22 monthly 0.8 https://www.510kdatabase.net/og-image/k250901-vantage-fortianorian-15t-mrt-1550-v100-fda-510k.jpg K250901 - Vantage Fortian/Orian 1.5T, MRT-1550, V10.0 with AiCE Reconstruction Processing Unit for MR K250901 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Jul 2025. https://www.510kdatabase.net/k251255/ 2025-07-22 monthly 0.8 https://www.510kdatabase.net/og-image/k251255-lymphatech-mobile-3d-measuring-tool-fda-510k.jpg K251255 - LymphaTech Mobile 3D Measuring Tool K251255 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lymphatech, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k251300/ 2025-07-22 monthly 0.8 https://www.510kdatabase.net/og-image/k251300-plastic-surgical-kits-fda-510k.jpg K251300 - Plastic Surgical Kits K251300 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Dentsply Sirona, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k251310/ 2025-07-22 monthly 0.8 https://www.510kdatabase.net/og-image/k251310-ots-25-l-100-5-fda-510k.jpg K251310 - OTS 25-L (100-5) K251310 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ots Medical , Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k251505/ 2025-07-22 monthly 0.8 https://www.510kdatabase.net/og-image/k251505-versacoat-nerve-protector-vtp-44g2-fda-510k.jpg K251505 - VersaCoat Nerve Protector (VTP-44G2) K251505 is a FDA 510(k) cleared neurology medical device. Manufacturer: Alafair Biosciences. Cleared Jul 2025. https://www.510kdatabase.net/k251616/ 2025-07-22 monthly 0.8 https://www.510kdatabase.net/og-image/k251616-clear-miracle-fda-510k.jpg K251616 - Clear Miracle K251616 is a FDA 510(k) cleared dental medical device. Manufacturer: Ods Co., Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k251638/ 2025-07-22 monthly 0.8 https://www.510kdatabase.net/og-image/k251638-mobility-scooter-ms160c-fda-510k.jpg K251638 - Mobility Scooter (MS160C) K251638 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Suzhou Master Machinery Manufacturing Co.,Ltd. Cleared Jul 2025. https://www.510kdatabase.net/k251564/ 2025-07-21 monthly 0.8 https://www.510kdatabase.net/og-image/k251564-microinr-system-fda-510k.jpg K251564 - microINR System K251564 is a FDA 510(k) cleared hematology medical device. Manufacturer: Iline Microsystems, S.L.. Cleared Jul 2025. https://www.510kdatabase.net/k250913/ 2025-07-19 monthly 0.8 https://www.510kdatabase.net/og-image/k250913-tingsn-finders-2-color-doppler-fda-510k.jpg K250913 - TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound System K250913 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Jiangsu Tingsn Technology Co., Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k231562/ 2025-07-18 monthly 0.8 https://www.510kdatabase.net/og-image/k231562-elec-engine-model-ise-170l-fda-510k.jpg K231562 - ELEC ENGINE (Model: ISE-170L) K231562 is a FDA 510(k) cleared dental medical device. Manufacturer: Micro-Nx Co., Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k243404/ 2025-07-18 monthly 0.8 https://www.510kdatabase.net/og-image/k243404-hyhub-and-hyhub-duo-vial-access-devices-fda-510k.jpg K243404 - HyHub™ and HyHub™ Duo Vial Access Devices K243404 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Takeda Pharmaceuticals. Cleared Jul 2025. https://www.510kdatabase.net/k243775/ 2025-07-18 monthly 0.8 https://www.510kdatabase.net/og-image/k243775-true-non-surgical-spinal-decompression-fda-510k.jpg K243775 - True Non-Surgical Spinal Decompression System (DRX9000-SL) K243775 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Excite Medical of Tampa Bay, LLC. Cleared Jul 2025. https://www.510kdatabase.net/k250084/ 2025-07-18 monthly 0.8 https://www.510kdatabase.net/og-image/k250084-microscan-dried-gram-negative-miccombo-fda-510k.jpg K250084 - MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL) K250084 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k250553/ 2025-07-18 monthly 0.8 https://www.510kdatabase.net/og-image/k250553-tomey-corneaanterior-segment-oct-casia2-fda-510k.jpg K250553 - Tomey Cornea/Anterior Segment OCT (CASIA2) K250553 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Tomey Corporation. Cleared Jul 2025. https://www.510kdatabase.net/k250750/ 2025-07-18 monthly 0.8 https://www.510kdatabase.net/og-image/k250750-innovision-p5-fda-510k.jpg K250750 - INNOVISION-P5 K250750 is a FDA 510(k) cleared radiology medical device. Manufacturer: Dk Medical Systems Co., Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k250902/ 2025-07-18 monthly 0.8 https://www.510kdatabase.net/og-image/k250902-heartflow-analysis-fda-510k.jpg K250902 - HeartFlow Analysis K250902 is a FDA 510(k) cleared radiology medical device. Manufacturer: HeartFlow, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k250952/ 2025-07-18 monthly 0.8 https://www.510kdatabase.net/og-image/k250952-baby-gorillagorilla-plating-system-fda-510k.jpg K250952 - Baby Gorilla®/Gorilla® Plating System K250952 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paragon 28, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k250999/ 2025-07-18 monthly 0.8 https://www.510kdatabase.net/og-image/k250999-v8-diagnostic-ultrasound-system-fda-510k.jpg K250999 - V8 Diagnostic Ultrasound System K250999 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Medison Co., Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k251542/ 2025-07-18 monthly 0.8 https://www.510kdatabase.net/og-image/k251542-instafan-fda-510k.jpg K251542 - InstaFAN K251542 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Onepass Medical , Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k251585/ 2025-07-18 monthly 0.8 https://www.510kdatabase.net/og-image/k251585-profoject-enteral-feeding-syringe-fda-510k.jpg K251585 - Profoject™ Enteral Feeding Syringe K251585 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: CMT Health PTE., Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k251655/ 2025-07-18 monthly 0.8 https://www.510kdatabase.net/og-image/k251655-versacoat-tendon-protector-vtp-44g2-fda-510k.jpg K251655 - VersaCoat Tendon Protector (VTP-44G2) K251655 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alafair Biosciences. Cleared Jul 2025. https://www.510kdatabase.net/k251809/ 2025-07-18 monthly 0.8 https://www.510kdatabase.net/og-image/k251809-arthrex-fibertak-suture-anchor-fda-510k.jpg K251809 - Arthrex FiberTak Suture Anchor K251809 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k251906/ 2025-07-18 monthly 0.8 https://www.510kdatabase.net/og-image/k251906-z1-hip-system-fda-510k.jpg K251906 - Z1 Hip System K251906 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k252012/ 2025-07-18 monthly 0.8 https://www.510kdatabase.net/og-image/k252012-spy-cystoscopehysteroscope-fda-510k.jpg K252012 - SPY Cystoscope/Hysteroscope K252012 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Stryker Endoscopy. Cleared Jul 2025. https://www.510kdatabase.net/k252218/ 2025-07-18 monthly 0.8 https://www.510kdatabase.net/og-image/k252218-mf-sc-gen2-facial-toning-system-fda-510k.jpg K252218 - MF SC GEN2 Facial Toning System K252218 is a FDA 510(k) cleared neurology medical device. Manufacturer: Micro Current Technology, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k242505/ 2025-07-17 monthly 0.8 https://www.510kdatabase.net/og-image/k242505-elecsys-cortisol-iii-fda-510k.jpg K242505 - Elecsys Cortisol III K242505 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Jul 2025. https://www.510kdatabase.net/k243324/ 2025-07-17 monthly 0.8 https://www.510kdatabase.net/og-image/k243324-masimo-o3-regional-oximeter-fda-510k.jpg K243324 - Masimo O3 Regional Oximeter K243324 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Masimo Corporation. Cleared Jul 2025. https://www.510kdatabase.net/k243420/ 2025-07-17 monthly 0.8 https://www.510kdatabase.net/og-image/k243420-hestia-fda-510k.jpg K243420 - HESTIA K243420 is a FDA 510(k) cleared radiology medical device. Manufacturer: Genoray Co., Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k243428/ 2025-07-17 monthly 0.8 https://www.510kdatabase.net/og-image/k243428-e2coiltm-imaging-system-for-the-fda-510k.jpg K243428 - e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector K243428 is a FDA 510(k) cleared radiology medical device. Manufacturer: Dxtx Medical, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k243547/ 2025-07-17 monthly 0.8 https://www.510kdatabase.net/og-image/k243547-umr-ultra-fda-510k.jpg K243547 - uMR Ultra K243547 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k243756/ 2025-07-17 monthly 0.8 https://www.510kdatabase.net/og-image/k243756-0014-willow-guidewire-fda-510k.jpg K243756 - 0.014” Willow Guidewire K243756 is a FDA 510(k) cleared neurology medical device. Manufacturer: Arbor Endovascular, LLC. Cleared Jul 2025. https://www.510kdatabase.net/k250751/ 2025-07-17 monthly 0.8 https://www.510kdatabase.net/og-image/k250751-dualview-catheter-fda-510k.jpg K250751 - DualView Catheter K250751 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Corporation. Cleared Jul 2025. https://www.510kdatabase.net/k251016/ 2025-07-17 monthly 0.8 https://www.510kdatabase.net/og-image/k251016-mectalif-3d-metal-fda-510k.jpg K251016 - MectaLIF 3D Metal K251016 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Jul 2025. https://www.510kdatabase.net/k251175/ 2025-07-17 monthly 0.8 https://www.510kdatabase.net/og-image/k251175-versawrap-nerve-protector-vtp-2201-fda-510k.jpg K251175 - VersaWrap Nerve Protector (VTP-2201) K251175 is a FDA 510(k) cleared neurology medical device. Manufacturer: Alafair Biosciences. Cleared Jul 2025. https://www.510kdatabase.net/k251491/ 2025-07-17 monthly 0.8 https://www.510kdatabase.net/og-image/k251491-k5-cart-k5-mount-k5-swing-fda-510k.jpg K251491 - K5 Cart, K5 Mount, K5 Swing K251491 is a FDA 510(k) cleared dental medical device. Manufacturer: Osstem Implant Company., Ltd. Chair Business. Cleared Jul 2025. https://www.510kdatabase.net/k251556/ 2025-07-17 monthly 0.8 https://www.510kdatabase.net/og-image/k251556-device-300423-granules-fda-510k.jpg K251556 - Device 300423 Granules K251556 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Geistlich Pharma AG. Cleared Jul 2025. https://www.510kdatabase.net/k251839/ 2025-07-17 monthly 0.8 https://www.510kdatabase.net/og-image/k251839-umi-panvivo-umi-panvivo-fda-510k.jpg K251839 - uMI Panvivo (uMI Panvivo) K251839 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k243397/ 2025-07-16 monthly 0.8 https://www.510kdatabase.net/og-image/k243397-umr-680-fda-510k.jpg K243397 - uMR 680 K243397 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k243412/ 2025-07-16 monthly 0.8 https://www.510kdatabase.net/og-image/k243412-archimedes-biodegradable-pancreatic-fda-510k.jpg K243412 - ARCHIMEDES Biodegradable Pancreatic Stent K243412 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.). Cleared Jul 2025. https://www.510kdatabase.net/k243782/ 2025-07-16 monthly 0.8 https://www.510kdatabase.net/og-image/k243782-stimtrial-neuromodulation-system-fda-510k.jpg K243782 - StimTrial Neuromodulation System K243782 is a FDA 510(k) cleared neurology medical device. Manufacturer: Bioventus, LLC. Cleared Jul 2025. https://www.510kdatabase.net/k250949/ 2025-07-16 monthly 0.8 https://www.510kdatabase.net/og-image/k250949-suction-valve-maj-1443-fda-510k.jpg K250949 - Suction Valve (MAJ-1443) K250949 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Medical Systems Corporation. Cleared Jul 2025. https://www.510kdatabase.net/k251102/ 2025-07-16 monthly 0.8 https://www.510kdatabase.net/og-image/k251102-automatic-blood-pressure-monitor-ch-fda-510k.jpg K251102 - Automatic Blood Pressure Monitor (CH-S691L, CH-B607, CH-B606, CH-S692L, CH-S602, CH-W701L, CH-S693L, CH-B601L, CP-B01, CH-S603) K251102 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cemho Medical Technology (Guangdong) Co., Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k251151/ 2025-07-16 monthly 0.8 https://www.510kdatabase.net/og-image/k251151-rapid-cta-360-fda-510k.jpg K251151 - Rapid CTA 360 K251151 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ischemaview. Cleared Jul 2025. https://www.510kdatabase.net/k251198/ 2025-07-16 monthly 0.8 https://www.510kdatabase.net/og-image/k251198-hypervue-software-fda-510k.jpg K251198 - HyperVue™ Software K251198 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Spectrawave, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k251202/ 2025-07-16 monthly 0.8 https://www.510kdatabase.net/og-image/k251202-da-vinci-surgical-system-is5000-fda-510k.jpg K251202 - da Vinci Surgical System (IS5000) K251202 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k251342/ 2025-07-16 monthly 0.8 https://www.510kdatabase.net/og-image/k251342-echopac-software-only-echopac-plug-in-fda-510k.jpg K251342 - EchoPAC Software Only / EchoPAC Plug-in K251342 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared Jul 2025. https://www.510kdatabase.net/k251845/ 2025-07-16 monthly 0.8 https://www.510kdatabase.net/og-image/k251845-marigen-wound-extra-fda-510k.jpg K251845 - Marigen Wound Extra K251845 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Kerecis Limited. Cleared Jul 2025. https://www.510kdatabase.net/k242237/ 2025-07-15 monthly 0.8 https://www.510kdatabase.net/og-image/k242237-jewel-soft-tissue-reinforcement-device-fda-510k.jpg K242237 - Jewel Soft Tissue Reinforcement Device (102-6005) K242237 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Xiros Limited. Cleared Jul 2025. https://www.510kdatabase.net/k242818/ 2025-07-15 monthly 0.8 https://www.510kdatabase.net/og-image/k242818-isosphere-fda-510k.jpg K242818 - IsoSphere K242818 is a FDA 510(k) cleared radiology medical device. Manufacturer: Isoaid, LLC. Cleared Jul 2025. https://www.510kdatabase.net/k250119/ 2025-07-15 monthly 0.8 https://www.510kdatabase.net/og-image/k250119-tempus-ecg-low-ef-fda-510k.jpg K250119 - Tempus ECG-Low EF K250119 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Tempus AI, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k250181/ 2025-07-15 monthly 0.8 https://www.510kdatabase.net/og-image/k250181-av-viewer-fda-510k.jpg K250181 - AV Viewer K250181 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Jul 2025. https://www.510kdatabase.net/k250350/ 2025-07-15 monthly 0.8 https://www.510kdatabase.net/og-image/k250350-thrive-2-in-1-breast-pump-model-p3-fda-510k.jpg K250350 - Thrive 2-in-1 Breast Pump (Model P3) K250350 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shenzhen TPH Technology Co., Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k251045/ 2025-07-15 monthly 0.8 https://www.510kdatabase.net/og-image/k251045-disposable-neonatal-nibp-cuff-u1682s-fda-510k.jpg K251045 - Disposable Neonatal NIBP Cuff (U1682S-C51N) K251045 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Unimed Medical Supplies, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k251053/ 2025-07-15 monthly 0.8 https://www.510kdatabase.net/og-image/k251053-shinetell-plustm-digital-early-fda-510k.jpg K251053 - Shinetell PlusTM Digital Early Pregnancy Test K251053 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Hangzhou AllTest Biotech Co., Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k251844/ 2025-07-15 monthly 0.8 https://www.510kdatabase.net/og-image/k251844-kerecis-surgibind-50241-fda-510k.jpg K251844 - Kerecis SurgiBind (50241) K251844 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Kerecis Limited. Cleared Jul 2025. https://www.510kdatabase.net/k243917/ 2025-07-14 monthly 0.8 https://www.510kdatabase.net/og-image/k243917-fp-optiflow-airoxygen-flow-source-fda-510k.jpg K243917 - F&P Optiflow Air/Oxygen Flow Source K243917 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Fisher &Paykel Healthcare , Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k250120/ 2025-07-14 monthly 0.8 https://www.510kdatabase.net/og-image/k250120-gecho-fda-510k.jpg K250120 - GECHO K250120 is a FDA 510(k) cleared radiology medical device. Manufacturer: Narnar, LLC. Cleared Jul 2025. https://www.510kdatabase.net/k250185/ 2025-07-14 monthly 0.8 https://www.510kdatabase.net/og-image/k250185-electronic-sphygmomanometers-zh-x9-zh-fda-510k.jpg K250185 - Electronic Sphygmomanometers (ZH-X9, ZH-X12, ZH-X16, ZH-X17, ZH-X18, ZH-X19, ZH-X23, ZH-X24) K250185 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Jiangxi Aicare Medical Technology Co., Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k250504/ 2025-07-14 monthly 0.8 https://www.510kdatabase.net/og-image/k250504-leonardo-duster-fda-510k.jpg K250504 - Leonardo Duster K250504 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ceramoptec GmbH. Cleared Jul 2025. https://www.510kdatabase.net/k250660/ 2025-07-14 monthly 0.8 https://www.510kdatabase.net/og-image/k250660-luminos-qnamix-t-fda-510k.jpg K250660 - LUMINOS Q.namix T K250660 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions. Cleared Jul 2025. https://www.510kdatabase.net/k251096/ 2025-07-14 monthly 0.8 https://www.510kdatabase.net/og-image/k251096-peekmed-web-fda-510k.jpg K251096 - PeekMed web K251096 is a FDA 510(k) cleared radiology medical device. Manufacturer: Peek Health, S.A.. Cleared Jul 2025. https://www.510kdatabase.net/k251132/ 2025-07-14 monthly 0.8 https://www.510kdatabase.net/og-image/k251132-the-acumed-wrist-fixation-system-plates-fda-510k.jpg K251132 - The Acumed Wrist Fixation System - Plates K251132 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Acumed, LLC. Cleared Jul 2025. https://www.510kdatabase.net/k251173/ 2025-07-14 monthly 0.8 https://www.510kdatabase.net/og-image/k251173-intense-pulsed-light-ipl-system-t033kq-fda-510k.jpg K251173 - Intense Pulsed Light (IPL) System (T033KQ, T033KD, T033KF, T033MQ, T033MD, T033MF, T055KQ, T055KD, T055KH, T002AQ, T002AD, T002AF, T002BQ, T002BD, T002BF, T050KQ, T050KD, T050KF) K251173 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Fansizhe Science And Technology Co., Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k251378/ 2025-07-14 monthly 0.8 https://www.510kdatabase.net/og-image/k251378-cooltone-fda-510k.jpg K251378 - CoolTone K251378 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zimmer Medizinsysteme GmbH. Cleared Jul 2025. https://www.510kdatabase.net/k251488/ 2025-07-14 monthly 0.8 https://www.510kdatabase.net/og-image/k251488-flowrunner-aspiration-system-fda-510k.jpg K251488 - FLOWRUNNER Aspiration System K251488 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Expanse Medical, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k251554/ 2025-07-14 monthly 0.8 https://www.510kdatabase.net/og-image/k251554-materialise-tka-guide-system-fda-510k.jpg K251554 - Materialise TKA Guide System K251554 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Materialise NV. Cleared Jul 2025. https://www.510kdatabase.net/k251850/ 2025-07-14 monthly 0.8 https://www.510kdatabase.net/og-image/k251850-phantom-hindfoot-ttctc-nail-system-fda-510k.jpg K251850 - Phantom® Hindfoot TTC/TC Nail System K251850 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paragon 28, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k243598/ 2025-07-13 monthly 0.8 https://www.510kdatabase.net/og-image/k243598-welch-allyn-connex-360-multiple-fda-510k.jpg K243598 - Welch Allyn Connex® 360 (Multiple) K243598 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Welch Allyn, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k243199/ 2025-07-12 monthly 0.8 https://www.510kdatabase.net/og-image/k243199-nightwatch-us-fda-510k.jpg K243199 - NightWatch+ US K243199 is a FDA 510(k) cleared neurology medical device. Manufacturer: Livassured BV. Cleared Jul 2025. https://www.510kdatabase.net/k241179/ 2025-07-11 monthly 0.8 https://www.510kdatabase.net/og-image/k241179-rhythm-express-remote-cardiac-fda-510k.jpg K241179 - Rhythm Express Remote Cardiac Monitoring System (RX-1 mini) K241179 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vivaquant, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k243227/ 2025-07-11 monthly 0.8 https://www.510kdatabase.net/og-image/k243227-b-scan-fda-510k.jpg K243227 - B-Scan K243227 is a FDA 510(k) cleared radiology medical device. Manufacturer: Accutome, Inc. Doing Business AS Keeler USA. Cleared Jul 2025. https://www.510kdatabase.net/k243274/ 2025-07-11 monthly 0.8 https://www.510kdatabase.net/og-image/k243274-cdc-human-influenza-virus-real-time-rt-fda-510k.jpg K243274 - CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2) K243274 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Centers For Disease Control and Prevention. Cleared Jul 2025. https://www.510kdatabase.net/k243296/ 2025-07-11 monthly 0.8 https://www.510kdatabase.net/og-image/k243296-disposable-biopsy-needle-fda-510k.jpg K243296 - Disposable Biopsy Needle K243296 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Carbon (Shenzhen) Medical Device Co., Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k243655/ 2025-07-11 monthly 0.8 https://www.510kdatabase.net/og-image/k243655-turbalign-fda-510k.jpg K243655 - TurbAlign K243655 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Spirair, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k250034/ 2025-07-11 monthly 0.8 https://www.510kdatabase.net/og-image/k250034-natural-rubber-latex-male-condom-fda-510k.jpg K250034 - Natural rubber latex male condom K250034 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shaoguan Regenex Pharmaceuticals Co., Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k250156/ 2025-07-11 monthly 0.8 https://www.510kdatabase.net/og-image/k250156-choice-2-dc-fda-510k.jpg K250156 - Choice 2 DC K250156 is a FDA 510(k) cleared dental medical device. Manufacturer: Bisco, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k250266/ 2025-07-11 monthly 0.8 https://www.510kdatabase.net/og-image/k250266-ceragem-automatic-thermal-massager-cgm-fda-510k.jpg K250266 - Ceragem Automatic Thermal Massager (CGM MB-2401) K250266 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Ceragem Co., Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k250671/ 2025-07-11 monthly 0.8 https://www.510kdatabase.net/og-image/k250671-freestyle-comfort-as200-freestyle-fda-510k.jpg K250671 - FreeStyle Comfort (AS200 / FreeStyle Comfort) K250671 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Caire, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k250761/ 2025-07-11 monthly 0.8 https://www.510kdatabase.net/og-image/k250761-kala-therapy-wand-model-kala-03-fda-510k.jpg K250761 - KALA Therapy Wand (Model: KALA-03) K250761 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Kaiyan Medical Equipment Co., Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k250762/ 2025-07-11 monthly 0.8 https://www.510kdatabase.net/og-image/k250762-ultrasonic-probe-um-s20-17s-um-s20-17s-fda-510k.jpg K250762 - ULTRASONIC PROBE UM-S20-17S (UM-S20-17S) K250762 is a FDA 510(k) cleared radiology medical device. Manufacturer: Olympus Medical Systems Corporation. Cleared Jul 2025. https://www.510kdatabase.net/k250772/ 2025-07-11 monthly 0.8 https://www.510kdatabase.net/og-image/k250772-medline-renewal-reprocessed-boston-fda-510k.jpg K250772 - Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter K250772 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Surgical Instrument Service and Savings, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k250820/ 2025-07-11 monthly 0.8 https://www.510kdatabase.net/og-image/k250820-disposable-trocars-fda-510k.jpg K250820 - Disposable Trocars K250820 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sinolinks Medical Innovation, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k250942/ 2025-07-11 monthly 0.8 https://www.510kdatabase.net/og-image/k250942-ice-cooling-ipl-hair-removal-device-fda-510k.jpg K250942 - Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK, UI20 DB, UI20 RE, UI20 PW, UI20 GP, UI20 GR, UI20 BK) K250942 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Ulike Smart Electronics Co., Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k251134/ 2025-07-11 monthly 0.8 https://www.510kdatabase.net/og-image/k251134-ripcord-fda-510k.jpg K251134 - RipCord K251134 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: TriMed, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k251149/ 2025-07-11 monthly 0.8 https://www.510kdatabase.net/og-image/k251149-aviclear-laser-system-fda-510k.jpg K251149 - AviClear Laser System K251149 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cutera, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k251155/ 2025-07-11 monthly 0.8 https://www.510kdatabase.net/og-image/k251155-bd-cathena-safety-iv-catheter-fda-510k.jpg K251155 - BD Cathena™ Safety IV Catheter K251155 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton Dickinson Infusion Therapy Systems, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k251352/ 2025-07-11 monthly 0.8 https://www.510kdatabase.net/og-image/k251352-codonics-safe-labeling-system-point-of-fda-510k.jpg K251352 - Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features) K251352 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Codonics.Incorporated. Cleared Jul 2025. https://www.510kdatabase.net/k251436/ 2025-07-11 monthly 0.8 https://www.510kdatabase.net/og-image/k251436-resolve-anterior-cervical-plate-system-fda-510k.jpg K251436 - Resolve Anterior Cervical Plate System K251436 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Pioneer Surgical Technology, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k251470/ 2025-07-11 monthly 0.8 https://www.510kdatabase.net/og-image/k251470-resicem-ex-fda-510k.jpg K251470 - ResiCem EX K251470 is a FDA 510(k) cleared dental medical device. Manufacturer: Shofu Dental Corporation. Cleared Jul 2025. https://www.510kdatabase.net/k251472/ 2025-07-11 monthly 0.8 https://www.510kdatabase.net/og-image/k251472-inion-cps-152025-bioabsorbable-fda-510k.jpg K251472 - Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System K251472 is a FDA 510(k) cleared neurology medical device. Manufacturer: Inion OY. Cleared Jul 2025. https://www.510kdatabase.net/k251482/ 2025-07-11 monthly 0.8 https://www.510kdatabase.net/og-image/k251482-aeon-endoscopic-powered-stapler-fda-510k.jpg K251482 - AEON™ Endoscopic Powered Stapler K251482 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lexington Medical, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k251786/ 2025-07-11 monthly 0.8 https://www.510kdatabase.net/og-image/k251786-geistlich-bio-oss-fda-510k.jpg K251786 - Geistlich Bio-Oss® K251786 is a FDA 510(k) cleared dental medical device. Manufacturer: Geistlich Pharma AG. Cleared Jul 2025. https://www.510kdatabase.net/k251808/ 2025-07-11 monthly 0.8 https://www.510kdatabase.net/og-image/k251808-achieva-fda-510k.jpg K251808 - Achieva K251808 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Jul 2025. https://www.510kdatabase.net/k243252/ 2025-07-10 monthly 0.8 https://www.510kdatabase.net/og-image/k243252-zbpro-diagnostic-fda-510k.jpg K243252 - ZBPro Diagnostic K243252 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Zbeats, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k244004/ 2025-07-10 monthly 0.8 https://www.510kdatabase.net/og-image/k244004-microcurrent-facial-device-cec101-fda-510k.jpg K244004 - Microcurrent Facial Device (CEC101, EE0101, EEI101) K244004 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Dachi Communication Co., Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k250032/ 2025-07-10 monthly 0.8 https://www.510kdatabase.net/og-image/k250032-marquee-disposable-core-biopsy-fda-510k.jpg K250032 - Marquee™ Disposable Core Biopsy Instrument and Instrument Kit K250032 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bard Peripheral Vascular, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k250063/ 2025-07-10 monthly 0.8 https://www.510kdatabase.net/og-image/k250063-arena-star-galaxy-star-fda-510k.jpg K250063 - ARENA Star, Galaxy Star K250063 is a FDA 510(k) cleared dental medical device. Manufacturer: Arum Dentistry Co., Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k250072/ 2025-07-10 monthly 0.8 https://www.510kdatabase.net/og-image/k250072-conduit-synfix-evolution-secured-fda-510k.jpg K250072 - CONDUIT™ SYNFIX™ Evolution Secured Spacer System K250072 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Avalign Technologies, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k250283/ 2025-07-10 monthly 0.8 https://www.510kdatabase.net/og-image/k250283-rap-femoral-venous-cannulae-fda-510k.jpg K250283 - RAP Femoral Venous Cannulae K250283 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: LivaNova USA, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k251145/ 2025-07-10 monthly 0.8 https://www.510kdatabase.net/og-image/k251145-arthrex-pushlock-suture-anchors-fda-510k.jpg K251145 - Arthrex PushLock Suture Anchors K251145 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k251169/ 2025-07-10 monthly 0.8 https://www.510kdatabase.net/og-image/k251169-vivid-pioneer-fda-510k.jpg K251169 - Vivid Pioneer K251169 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared Jul 2025. https://www.510kdatabase.net/k251830/ 2025-07-10 monthly 0.8 https://www.510kdatabase.net/og-image/k251830-sonosite-lx-ultrasound-system-fda-510k.jpg K251830 - Sonosite LX Ultrasound System K251830 is a FDA 510(k) cleared radiology medical device. Manufacturer: FUJIFILM Sonosite, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k251885/ 2025-07-10 monthly 0.8 https://www.510kdatabase.net/og-image/k251885-cavux-facet-fixation-system-cavux-ffs-fda-510k.jpg K251885 - CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant K251885 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Providence Medical Technology, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k251945/ 2025-07-10 monthly 0.8 https://www.510kdatabase.net/og-image/k251945-trimed-total-wrist-fusion-system-total-fda-510k.jpg K251945 - TriMed Total Wrist Fusion System (Total Wrist Fusion Plate) K251945 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: TriMed, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k242562/ 2025-07-09 monthly 0.8 https://www.510kdatabase.net/og-image/k242562-monitor-b105m-fda-510k.jpg K242562 - Monitor B105M K242562 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k243500/ 2025-07-09 monthly 0.8 https://www.510kdatabase.net/og-image/k243500-architect-igentamicin-fda-510k.jpg K243500 - ARCHITECT iGentamicin K243500 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Jul 2025. https://www.510kdatabase.net/k243731/ 2025-07-09 monthly 0.8 https://www.510kdatabase.net/og-image/k243731-hexim-implant-fda-510k.jpg K243731 - HEXIM Implant K243731 is a FDA 510(k) cleared dental medical device. Manufacturer: P&A USA. Cleared Jul 2025. https://www.510kdatabase.net/k250108/ 2025-07-09 monthly 0.8 https://www.510kdatabase.net/og-image/k250108-optivu-shoulder-fda-510k.jpg K250108 - OptiVu™ Shoulder K250108 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Mr Surgical Solutions, LLC. Cleared Jul 2025. https://www.510kdatabase.net/k250133/ 2025-07-09 monthly 0.8 https://www.510kdatabase.net/og-image/k250133-harbor-occlusion-device-fda-510k.jpg K250133 - HARBOR Occlusion Device K250133 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nuvascular, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k250193/ 2025-07-09 monthly 0.8 https://www.510kdatabase.net/og-image/k250193-nitrile-powder-free-exam-gloves-28-fda-510k.jpg K250193 - Nitrile Powder-Free Exam Gloves 2.8, Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (light blue, dark blue) K250193 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Basic Medical Technology, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k250247/ 2025-07-09 monthly 0.8 https://www.510kdatabase.net/og-image/k250247-panasia-si-fusion-system-fda-510k.jpg K250247 - panaSIa SI Fusion System K250247 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wenzel Spine, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k250505/ 2025-07-09 monthly 0.8 https://www.510kdatabase.net/og-image/k250505-ez-fiducials-fda-510k.jpg K250505 - EZ-FIDUCIALS K250505 is a FDA 510(k) cleared neurology medical device. Manufacturer: Phasor Health, LLC. Cleared Jul 2025. https://www.510kdatabase.net/k251520/ 2025-07-09 monthly 0.8 https://www.510kdatabase.net/og-image/k251520-cios-alpha-fda-510k.jpg K251520 - Cios Alpha K251520 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k251759/ 2025-07-09 monthly 0.8 https://www.510kdatabase.net/og-image/k251759-flexiva-pulse-laser-fiber-fda-510k.jpg K251759 - Flexiva Pulse Laser Fiber K251759 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Jul 2025. https://www.510kdatabase.net/k240908/ 2025-07-08 monthly 0.8 https://www.510kdatabase.net/og-image/k240908-quantum-micro-cardioplegia-delivery-fda-510k.jpg K240908 - Quantum Micro-Cardioplegia Delivery System K240908 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Spectrum Medical , Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k241525/ 2025-07-08 monthly 0.8 https://www.510kdatabase.net/og-image/k241525-excelsiusxr-fda-510k.jpg K241525 - ExcelsiusXR™ K241525 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k250065/ 2025-07-08 monthly 0.8 https://www.510kdatabase.net/og-image/k250065-density-fda-510k.jpg K250065 - DENSITY K250065 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Jeisys Medical Incorporated. Cleared Jul 2025. https://www.510kdatabase.net/k250342/ 2025-07-08 monthly 0.8 https://www.510kdatabase.net/og-image/k250342-powder-free-polychloroprene-fda-510k.jpg K250342 - Powder-Free Polychloroprene Examination Glove (Green Color) Tested for Use with Chemotherapy Drugs and Fentanyl K250342 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Encompass Industries Sdn. Bhd.. Cleared Jul 2025. https://www.510kdatabase.net/k250695/ 2025-07-08 monthly 0.8 https://www.510kdatabase.net/og-image/k250695-single-use-ureteral-access-sheath-fda-510k.jpg K250695 - Single-use Ureteral Access Sheath K250695 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Shenzhen HugeMed Medical Technical Development Co., Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k251447/ 2025-07-08 monthly 0.8 https://www.510kdatabase.net/og-image/k251447-k-pack-embrace-active-safety-needle-fda-510k.jpg K251447 - K-Pack Embrace Active Safety Needle (KNAS-2516RB, KNAS-2525RB) K251447 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terumo Europe N.V.. Cleared Jul 2025. https://www.510kdatabase.net/k251741/ 2025-07-08 monthly 0.8 https://www.510kdatabase.net/og-image/k251741-pathloc-lumbar-interbody-fusion-cage-fda-510k.jpg K251741 - PathLoc Lumbar Interbody Fusion Cage System K251741 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: L & K Biomed Co., Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k251761/ 2025-07-08 monthly 0.8 https://www.510kdatabase.net/og-image/k251761-anovo-surgical-system-model-6ne-fda-510k.jpg K251761 - Anovo Surgical System (Model 6Ne) K251761 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Momentis Surgical , Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k251766/ 2025-07-08 monthly 0.8 https://www.510kdatabase.net/og-image/k251766-tumorsight-viz-fda-510k.jpg K251766 - TumorSight Viz K251766 is a FDA 510(k) cleared radiology medical device. Manufacturer: SimBioSys, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k251776/ 2025-07-08 monthly 0.8 https://www.510kdatabase.net/og-image/k251776-empowr-revision-knee-empowr-revision-fda-510k.jpg K251776 - EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert) K251776 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Encore Medical, L.P.. Cleared Jul 2025. https://www.510kdatabase.net/k251804/ 2025-07-08 monthly 0.8 https://www.510kdatabase.net/og-image/k251804-kheiron-spinal-fixation-system-fda-510k.jpg K251804 - KHEIRON® Spinal Fixation System, including patient specific K-ROD K251804 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: S.M.A.I.O. Cleared Jul 2025. https://www.510kdatabase.net/k243884/ 2025-07-07 monthly 0.8 https://www.510kdatabase.net/og-image/k243884-tavipilot-fda-510k.jpg K243884 - TAVIPILOT K243884 is a FDA 510(k) cleared radiology medical device. Manufacturer: Caranx Medical. Cleared Jul 2025. https://www.510kdatabase.net/k250496/ 2025-07-07 monthly 0.8 https://www.510kdatabase.net/og-image/k250496-powder-free-polyurethane-examination-fda-510k.jpg K250496 - Powder Free Polyurethane Examination Gloves (Green, Blue, Pink, White) K250496 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zibo Shengkun Chemical Industry Co., Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k250827/ 2025-07-07 monthly 0.8 https://www.510kdatabase.net/og-image/k250827-aprevo-anterior-lumbar-interbody-fda-510k.jpg K250827 - aprevo® anterior lumbar interbody fusion device K250827 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Carlsmed, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k251502/ 2025-07-07 monthly 0.8 https://www.510kdatabase.net/og-image/k251502-trulift-lateral-expandable-spacer-fda-510k.jpg K251502 - TruLift® Lateral Expandable Spacer & Lateral Buttress Plate System K251502 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k251863/ 2025-07-07 monthly 0.8 https://www.510kdatabase.net/og-image/k251863-customsurg-orthoplanner-fda-510k.jpg K251863 - CustomSurg OrthoPlanner K251863 is a FDA 510(k) cleared radiology medical device. Manufacturer: Customsurg AG. Cleared Jul 2025. https://www.510kdatabase.net/k243123/ 2025-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k243123-ipl-treatment-device-mdsqmc-01-fda-510k.jpg K243123 - IPL Treatment Device (MDSQMC-01) K243123 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medusa (Guangxi)Medical Devices Co., Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k243207/ 2025-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k243207-bd-vacutainer-eclipse-blood-collection-fda-510k.jpg K243207 - BD Vacutainer® Eclipse™ Blood Collection Needle K243207 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson and Company. Cleared Jul 2025. https://www.510kdatabase.net/k243220/ 2025-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k243220-onera-sts-2-onera-sts-2-fda-510k.jpg K243220 - Onera STS 2 (ONERA STS 2) K243220 is a FDA 510(k) cleared neurology medical device. Manufacturer: Onera B.V.. Cleared Jul 2025. https://www.510kdatabase.net/k243255/ 2025-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k243255-uris-long-implant-abutments-fda-510k.jpg K243255 - URIS Long Implant & Abutments K243255 is a FDA 510(k) cleared dental medical device. Manufacturer: Truabutment, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k243280/ 2025-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k243280-piezomed-pro-piezomed-pro-module-m-fda-510k.jpg K243280 - Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories) K243280 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: W&H Dentalwerk Buermoos GmbH. Cleared Jul 2025. https://www.510kdatabase.net/k243678/ 2025-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k243678-talismann-neuromodulation-system-fda-510k.jpg K243678 - TalisMann Neuromodulation System K243678 is a FDA 510(k) cleared neurology medical device. Manufacturer: Bioventus, LLC. Cleared Jul 2025. https://www.510kdatabase.net/k243679/ 2025-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k243679-mammoscreen-4-fda-510k.jpg K243679 - MammoScreen® (4) K243679 is a FDA 510(k) cleared radiology medical device. Manufacturer: Therapixel. Cleared Jul 2025. https://www.510kdatabase.net/k243826/ 2025-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k243826-smr-reverse-hp-shoulder-system-fda-510k.jpg K243826 - SMR Reverse HP Shoulder System K243826 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Lima Corporate S.P.A.. Cleared Jul 2025. https://www.510kdatabase.net/k250105/ 2025-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k250105-boomerang-valvulotome-bmgvt080-fda-510k.jpg K250105 - Boomerang Valvulotome (BMGVT080) K250105 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Aveera Medical, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k250165/ 2025-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k250165-pastelle-fda-510k.jpg K250165 - Pastelle K250165 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wontech Co., Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k250286/ 2025-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k250286-rapid2-magnetic-stimulators-magstim-fda-510k.jpg K250286 - Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1) K250286 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: The Magstim Company Limited. Cleared Jul 2025. https://www.510kdatabase.net/k250398/ 2025-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k250398-innovita-flu-ab-antigen-rapid-test-fda-510k.jpg K250398 - Innovita Flu A/B Antigen Rapid Test K250398 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Innovita (Tangshan) Biological Technology Co., Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k250448/ 2025-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k250448-disposable-percutaneous-nephrostomy-fda-510k.jpg K250448 - Disposable Percutaneous Nephrostomy Dilatation Kit K250448 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Shenzhen Trious Medical Technology Co., Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k250733/ 2025-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k250733-3dose-1ml-syringe-fda-510k.jpg K250733 - 3DOSE 1ml Syringe K250733 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bimed Teknik Aletler Sanayi & Ticaret A.S.. Cleared Jul 2025. https://www.510kdatabase.net/k250822/ 2025-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k250822-somatom-gonow-fda-510k.jpg K250822 - SOMATOM go.Now K250822 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k250838/ 2025-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k250838-denudation-pipettes-fda-510k.jpg K250838 - Denudation Pipettes K250838 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Guangzhou Pinzhi Medical Device Co., Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k251054/ 2025-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k251054-hem-o-lok-purpleplus-large-polymer-fda-510k.jpg K251054 - Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips K251054 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Teleflex Medical. Cleared Jul 2025. https://www.510kdatabase.net/k251080/ 2025-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k251080-identiti-ii-cervical-interbody-system-fda-510k.jpg K251080 - IdentiTi II Cervical Interbody System K251080 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k251291/ 2025-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k251291-advanix-pancreatic-stent-and-naviflex-fda-510k.jpg K251291 - Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers K251291 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific. Cleared Jul 2025. https://www.510kdatabase.net/k251390/ 2025-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k251390-mta-vpt-fda-510k.jpg K251390 - MTA vpt K251390 is a FDA 510(k) cleared dental medical device. Manufacturer: Voco GmbH. Cleared Jul 2025. https://www.510kdatabase.net/k251528/ 2025-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k251528-syngovia-mi-workflows-fda-510k.jpg K251528 - syngo.via MI Workflows K251528 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k251599/ 2025-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k251599-single-use-ureteral-access-sheath-fda-510k.jpg K251599 - Single-use Ureteral Access Sheath K251599 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hunan Vathin Medical Instrument Co., Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k251671/ 2025-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k251671-biograph-vision-petct-systems-fda-510k.jpg K251671 - Biograph Vision PET/CT Systems K251671 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k243399/ 2025-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k243399-boehringer-laboratories-liver-retractor-fda-510k.jpg K243399 - Boehringer Laboratories Liver Retractor K243399 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Boehringer Laboratories, LLC. Cleared Jul 2025. https://www.510kdatabase.net/k243468/ 2025-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k243468-compressor-nebulizer-nb-1100-fda-510k.jpg K243468 - Compressor Nebulizer (NB-1100) K243468 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Joytech Healthcare Co. , Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k243701/ 2025-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k243701-aurolase-system-fda-510k.jpg K243701 - AuroLase® System K243701 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Nanospectra Biosciences, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k243868/ 2025-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k243868-pegavision-toufilcon-b-daily-fda-510k.jpg K243868 - Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses K243868 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Pegavision Corporation. Cleared Jul 2025. https://www.510kdatabase.net/k250279/ 2025-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k250279-rc-swiftprep-fda-510k.jpg K250279 - RC-SwiftPrep K250279 is a FDA 510(k) cleared dental medical device. Manufacturer: Belport Company, Inc., Gingi-Pak. Cleared Jul 2025. https://www.510kdatabase.net/k250312/ 2025-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k250312-hudson-rci-comfort-flo-nasal-cannula-fda-510k.jpg K250312 - Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant K250312 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Medline Industries, LP. Cleared Jul 2025. https://www.510kdatabase.net/k250391/ 2025-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k250391-leksell-gamma-knife-elekta-esprit-fda-510k.jpg K250391 - Leksell Gamma Knife® (Elekta Esprit) K250391 is a FDA 510(k) cleared radiology medical device. Manufacturer: Elekta Solutions AB. Cleared Jul 2025. https://www.510kdatabase.net/k250415/ 2025-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k250415-g0-blood-pressure-monitoring-system-g0-fda-510k.jpg K250415 - G0 Blood Pressure Monitoring System (G0) K250415 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Aktiia SA. Cleared Jul 2025. https://www.510kdatabase.net/k250524/ 2025-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k250524-mendaera-guidance-system-fda-510k.jpg K250524 - Mendaera Guidance System K250524 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mendaera, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k250587/ 2025-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k250587-orthoscan-tau-mini-c-arm-fda-510k.jpg K250587 - Orthoscan TAU Mini C-Arm K250587 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ziehm-Orthoscan, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k250684/ 2025-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k250684-opuswave-dual-sensor-imaging-system-fda-510k.jpg K250684 - OPUSWAVE Dual Sensor Imaging System K250684 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Cardiovascular Systems Thi Plant. Cleared Jul 2025. https://www.510kdatabase.net/k250729/ 2025-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k250729-power-wheelchair-mob1107-fda-510k.jpg K250729 - Power Wheelchair (MOB1107) K250729 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Vive Health, LLC. Cleared Jul 2025. https://www.510kdatabase.net/k250779/ 2025-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k250779-cs-pro-med-fda-510k.jpg K250779 - CS-Pro MED K250779 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Curative Sound Therapeutics. Cleared Jul 2025. https://www.510kdatabase.net/k250848/ 2025-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k250848-identity-shoulder-system-fda-510k.jpg K250848 - Identity Shoulder System K250848 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k251031/ 2025-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k251031-fiber-laser-treatment-systems-hs-232hs-fda-510k.jpg K251031 - Fiber Laser Treatment Systems (HS-232,HS-233) K251031 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shanghai Apolo Medical Technology Co., Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k251049/ 2025-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k251049-surgilight-1470-diode-laser-system-fda-510k.jpg K251049 - SurgiLight 1470 Diode Laser System (Model:Halo) K251049 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Micro-Energy Medical Technology Co., Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k251241/ 2025-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k251241-empowr-revision-knee-empowr-revision-fda-510k.jpg K251241 - EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones) K251241 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Encore Medical, L.P.. Cleared Jul 2025. https://www.510kdatabase.net/k251285/ 2025-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k251285-electric-wheelchair-hg-630-fda-510k.jpg K251285 - Electric Wheelchair (HG-630) K251285 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zhejiang Automwheel Tech Co., Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k251490/ 2025-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k251490-8-mm-assist-cannula-fda-510k.jpg K251490 - 8 mm Assist Cannula K251490 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k251720/ 2025-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k251720-osteoflo-hydrofiber-fda-510k.jpg K251720 - OsteoFlo HydroFiber K251720 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SurGenTec, LLC. Cleared Jul 2025. https://www.510kdatabase.net/k251746/ 2025-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k251746-pure-impact-fda-510k.jpg K251746 - Pure Impact K251746 is a FDA 510(k) cleared neurology medical device. Manufacturer: Sofwave Medical, Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k243485/ 2025-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k243485-alinity-m-cmv-fda-510k.jpg K243485 - Alinity m CMV K243485 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Molecular, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k243690/ 2025-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k243690-sonomsk-fda-510k.jpg K243690 - SonoMSK K243690 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: PAJUNK GmbH Medizintechnologie. Cleared Jul 2025. https://www.510kdatabase.net/k243779/ 2025-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k243779-bunkerhill-abdominal-aortic-fda-510k.jpg K243779 - Bunkerhill Abdominal Aortic Quantification (AAQ) K243779 is a FDA 510(k) cleared radiology medical device. Manufacturer: BunkerHill Health. Cleared Jul 2025. https://www.510kdatabase.net/k250016/ 2025-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k250016-droplet-personal-lancets-fda-510k.jpg K250016 - droplet® personal lancets K250016 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Htl-Strefa S.A. Cleared Jul 2025. https://www.510kdatabase.net/k250096/ 2025-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k250096-felix-neuroai-system-fda-510k.jpg K250096 - Felix NeuroAI System K250096 is a FDA 510(k) cleared neurology medical device. Manufacturer: Fasikl Incorporated. Cleared Jul 2025. https://www.510kdatabase.net/k250204/ 2025-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k250204-endoscopic-camera-system-fda-510k.jpg K250204 - Endoscopic Camera System K250204 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Sophway Technology Co., Ltd.. Cleared Jul 2025. https://www.510kdatabase.net/k250221/ 2025-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k250221-strokesens-aspects-software-application-fda-510k.jpg K250221 - StrokeSENS ASPECTS Software Application K250221 is a FDA 510(k) cleared radiology medical device. Manufacturer: Circle Cardiovascular Imaging, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k250699/ 2025-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k250699-cure-twist-female-8-catheter-t8-fda-510k.jpg K250699 - Cure Twist Female 8 Catheter (T8) K250699 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Convatec. Cleared Jul 2025. https://www.510kdatabase.net/k251032/ 2025-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k251032-minimed-780g-insulin-pump-fda-510k.jpg K251032 - MiniMed 780G insulin pump K251032 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Medtronic Minimed, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k251212/ 2025-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k251212-dual-lumen-5fr-hydropicc-catheter-picc-fda-510k.jpg K251212 - Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM) K251212 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Access Vascular, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k251453/ 2025-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k251453-arthrex-ibalance-partial-knee-system-fda-510k.jpg K251453 - Arthrex iBalance Partial Knee System K251453 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k251719/ 2025-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k251719-momentum-posterior-spinal-fixation-fda-510k.jpg K251719 - Momentum® Posterior Spinal Fixation System K251719 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ulrich Medical USA, Inc.. Cleared Jul 2025. https://www.510kdatabase.net/k251933/ 2025-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k251933-snugfit-asa-extension-fda-510k.jpg K251933 - SnugFit ASA Extension K251933 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Jul 2025. https://www.510kdatabase.net/k243647/ 2025-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k243647-synapse-pacs-75-fda-510k.jpg K243647 - Synapse PACS (7.5) K243647 is a FDA 510(k) cleared radiology medical device. Manufacturer: Fujifilm Healthcare Americas Corporation. Cleared Jun 2025. https://www.510kdatabase.net/k250022/ 2025-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k250022-herotracker-sense-fda-510k.jpg K250022 - HeroTracker Sense K250022 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Voluntis. Cleared Jun 2025. https://www.510kdatabase.net/k250484/ 2025-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k250484-piur-tus-inside-fda-510k.jpg K250484 - PIUR tUS inside K250484 is a FDA 510(k) cleared radiology medical device. Manufacturer: Piur Imaging GmbH. Cleared Jun 2025. https://www.510kdatabase.net/k250670/ 2025-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k250670-echoconfidence-usa-fda-510k.jpg K250670 - EchoConfidence (USA) K250670 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mycardium AI Limited. Cleared Jun 2025. https://www.510kdatabase.net/k250987/ 2025-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k250987-aprevo-posteriortransforaminal-lumbar-fda-510k.jpg K250987 - aprevo® posterior/transforaminal lumbar interbody fusion device K250987 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Carlsmed, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k250990/ 2025-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k250990-the-sensititre-18-24-hour-mic-or-fda-510k.jpg K250990 - The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in the dilution range of 0.002-64 ug/mL K250990 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Thermo Fisher Scientific. Cleared Jun 2025. https://www.510kdatabase.net/k251000/ 2025-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k251000-hand-held-hair-removal-device-fz-200a-fda-510k.jpg K251000 - Hand-held Hair Removal Device (FZ-200A, FZ-201, FZ-202, CT05, CT06, CT07, CT08, CT09) K251000 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Chuangtong Yigou Technology Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k251088/ 2025-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k251088-otsuka-digital-feedback-device-fda-510k.jpg K251088 - Otsuka Digital Feedback Device K251088 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Otsuka America Pharmaceutical, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k250972/ 2025-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k250972-primum-hydrophilic-guiding-catheter-fda-510k.jpg K250972 - Primum Hydrophilic Guiding Catheter K250972 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Pendracare. Cleared Jun 2025. https://www.510kdatabase.net/k242988/ 2025-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k242988-genostis-osteosynthesis-system-fda-510k.jpg K242988 - Genostis Osteosynthesis System K242988 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Genostis AF. Cleared Jun 2025. https://www.510kdatabase.net/k243077/ 2025-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k243077-affirm-800-fda-510k.jpg K243077 - Affirm 800 K243077 is a FDA 510(k) cleared neurology medical device. Manufacturer: Digital Surgery Systems, Inc. (D.B.A True Digital Surgery). Cleared Jun 2025. https://www.510kdatabase.net/k243130/ 2025-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k243130-integral-dental-unit-fda-510k.jpg K243130 - Integral Dental Unit K243130 is a FDA 510(k) cleared dental medical device. Manufacturer: Guangdong Yadeng Medical Apparatus Co., Ltd.,. Cleared Jun 2025. https://www.510kdatabase.net/k243144/ 2025-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k243144-x100x100ht-with-full-field-peripheral-fda-510k.jpg K243144 - X100/X100HT with Full Field Peripheral Blood Smear (PBS) Application K243144 is a FDA 510(k) cleared hematology medical device. Manufacturer: Scopio Labs , Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k243183/ 2025-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k243183-rtmsense-respiratory-monitoring-system-fda-510k.jpg K243183 - RTMsense Respiratory Monitoring System K243183 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Rtm Vital Signs, LLC. Cleared Jun 2025. https://www.510kdatabase.net/k243187/ 2025-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k243187-nisus-one-negative-pressure-wound-fda-510k.jpg K243187 - Nisus ONE Negative Pressure Wound Therapy System (OCMPP-100) K243187 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cork Medical. Cleared Jun 2025. https://www.510kdatabase.net/k243190/ 2025-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k243190-ustomed-bone-fixationbone-augmentation-fda-510k.jpg K243190 - USTOMED Bone Fixation/Bone Augmentation Systems - PIN K243190 is a FDA 510(k) cleared dental medical device. Manufacturer: Ustomed Instrumente Ulrich Storz GmbH & Co. KG. Cleared Jun 2025. https://www.510kdatabase.net/k243388/ 2025-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k243388-disposable-distal-cap-fda-510k.jpg K243388 - Disposable Distal Cap K243388 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Micro-Tech (Nanjing) Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k243682/ 2025-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k243682-sonoplex-stim-fda-510k.jpg K243682 - SonoPlex STIM K243682 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: PAJUNK GmbH Medizintechnologie. Cleared Jun 2025. https://www.510kdatabase.net/k243816/ 2025-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k243816-testa-tp-pivoting-spacer-system-fda-510k.jpg K243816 - Testa TP Pivoting Spacer System K243816 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spine Wave, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k243900/ 2025-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k243900-emotus-respiratory-motion-management-fda-510k.jpg K243900 - eMotus Respiratory Motion Management System K243900 is a FDA 510(k) cleared radiology medical device. Manufacturer: Empnia, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k250310/ 2025-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k250310-viking-fixed-curve-diagnostic-catheter-fda-510k.jpg K250310 - VIKING™ Fixed Curve Diagnostic Catheter K250310 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Jun 2025. https://www.510kdatabase.net/k250522/ 2025-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k250522-multi4-system-fda-510k.jpg K250522 - Multi4 System K250522 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Multi4 Medical AB. Cleared Jun 2025. https://www.510kdatabase.net/k250585/ 2025-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k250585-lumenatm-ureteral-access-sheath-fda-510k.jpg K250585 - LumenaTM Ureteral Access Sheath K250585 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cathegenix (Xiamen) Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k250610/ 2025-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k250610-easyflow-103-200-fda-510k.jpg K250610 - Easyflow (103-200 K250610 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sorin Group Italia S.R.L.. Cleared Jun 2025. https://www.510kdatabase.net/k250648/ 2025-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k250648-philips-ict-ct-system-fda-510k.jpg K250648 - Philips iCT CT system K250648 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Jun 2025. https://www.510kdatabase.net/k250828/ 2025-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k250828-cps-locator-3d-plus-delivery-catheter-fda-510k.jpg K250828 - CPS Locator 3D Plus Delivery Catheter K250828 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: CenterPoint Systems, LLC. Cleared Jun 2025. https://www.510kdatabase.net/k250969/ 2025-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k250969-jet-bite-fda-510k.jpg K250969 - JET BITE K250969 is a FDA 510(k) cleared dental medical device. Manufacturer: Dent4you AG. Cleared Jun 2025. https://www.510kdatabase.net/k250984/ 2025-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k250984-maestro-system-ref100-fda-510k.jpg K250984 - Maestro System (REF100) K250984 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Moon Surgical. Cleared Jun 2025. https://www.510kdatabase.net/k251116/ 2025-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k251116-luja-coud-fda-510k.jpg K251116 - Luja Coudé K251116 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Coloplast Corp.. Cleared Jun 2025. https://www.510kdatabase.net/k251210/ 2025-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k251210-ampa-one-system-ampa-001-fda-510k.jpg K251210 - Ampa One System (AMPA-001) K251210 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neuromodulatory Devices & Applications. Cleared Jun 2025. https://www.510kdatabase.net/k251329/ 2025-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k251329-diode-laser-device-rf3120-bi-fda-510k.jpg K251329 - Diode laser device (RF3120-BI) K251329 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Risu Medical Technology Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k251431/ 2025-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k251431-fix-c-peek-acif-sa-system-fda-510k.jpg K251431 - FIX-C PEEK ACIF SA System K251431 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Jeil Medical Corporation. Cleared Jun 2025. https://www.510kdatabase.net/k251642/ 2025-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k251642-dental-cbct-x-ray-system-fda-510k.jpg K251642 - Dental CBCT X-ray System K251642 is a FDA 510(k) cleared radiology medical device. Manufacturer: Yian Medical Technology (Haining) Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k251654/ 2025-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k251654-bd-insyte-autoguard-shielded-iv-fda-510k.jpg K251654 - BD Insyte™ Autoguard™ Shielded IV Catheter, BD Insyte™ Autoguard™ BC Shielded IV Catheter and BD Insyte™ Autoguard™ BC Pro Shielded IV Catheter K251654 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton Dickinson Infusion Therapy Systems, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k251660/ 2025-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k251660-t3-pro-implants-zimvie-packaging-system-fda-510k.jpg K251660 - T3 Pro Implants– ZimVie Packaging System K251660 is a FDA 510(k) cleared dental medical device. Manufacturer: Biomet 3i, LLC. Cleared Jun 2025. https://www.510kdatabase.net/k242846/ 2025-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k242846-doppler-fhr-detector-bf-500d-bf-560-fda-510k.jpg K242846 - Doppler FHR Detector (BF-500D+, BF-560) K242846 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shenzhen Bestman Instrument Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k243079/ 2025-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k243079-neurotrac-myoplus-pro-myo120u-fda-510k.jpg K243079 - NeuroTrac® MyoPlus Pro (MYO120U) K243079 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Verity Medical , Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k243175/ 2025-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k243175-disposable-intermittent-catheter-tpu-fda-510k.jpg K243175 - Disposable Intermittent Catheter (TPU Catheter) K243175 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Chengdu Daxan Innovative Medical Tech. Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k243179/ 2025-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k243179-sterilization-pouch-and-roll-fda-510k.jpg K243179 - Sterilization Pouch and Roll K243179 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Yichang Xinxin Paper Products Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k243275/ 2025-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k243275-equinoxe-scapula-fracture-system-fda-510k.jpg K243275 - Equinoxe® Scapula Fracture System K243275 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k243391/ 2025-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k243391-aisight-dx-fda-510k.jpg K243391 - AISight Dx K243391 is a FDA 510(k) cleared pathology medical device. Manufacturer: PathAI, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k243636/ 2025-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k243636-neuralytix-id3-system-ntx-9001-fda-510k.jpg K243636 - Neuralytix iD3 System (NTX-9001) K243636 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neuralytix, LLC. Cleared Jun 2025. https://www.510kdatabase.net/k250519/ 2025-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k250519-lapox-laparoscopic-tissue-oximeter-fda-510k.jpg K250519 - Lap.Ox™ Laparoscopic Tissue Oximeter K250519 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Vioptix, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k250548/ 2025-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k250548-arm-type-fully-automatic-digital-blood-fda-510k.jpg K250548 - Arm-type Fully Automatic Digital Blood Pressure Monitors (DBP-6286B, DBP-6186) K250548 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Joytech Healthcare Co. , Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k250929/ 2025-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k250929-trimed-ulnar-osteotomy-system-ulnar-fda-510k.jpg K250929 - TriMed Ulnar Osteotomy System (Ulnar Osteotomy Compression Plate) K250929 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: TriMed, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k250940/ 2025-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k250940-atmo-gas-capsule-system-fda-510k.jpg K250940 - Atmo Gas Capsule System K250940 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Atmo Biosciences, Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k250956/ 2025-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k250956-hardydisk-ast-gepotidacin-10g-gep10-fda-510k.jpg K250956 - HardyDisk AST Gepotidacin 10µg (GEP10) K250956 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Hardy Diagnostics. Cleared Jun 2025. https://www.510kdatabase.net/k250967/ 2025-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k250967-sherlock-fda-510k.jpg K250967 - Sherlock K250967 is a FDA 510(k) cleared dental medical device. Manufacturer: Open Implants, LLC. Cleared Jun 2025. https://www.510kdatabase.net/k251395/ 2025-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k251395-the-rialto-si-fusion-system-fda-510k.jpg K251395 - The Rialto™ SI Fusion System K251395 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k251613/ 2025-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k251613-swissgraft-x-fda-510k.jpg K251613 - SwissGraft X K251613 is a FDA 510(k) cleared dental medical device. Manufacturer: Geistlich Pharma AG. Cleared Jun 2025. https://www.510kdatabase.net/k251632/ 2025-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k251632-optimas-max-system-fda-510k.jpg K251632 - Optimas MAX System K251632 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Inmode , Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k251694/ 2025-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k251694-safety-lancet-fda-510k.jpg K251694 - safety lancet K251694 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Tianjin Huahong Technology Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k251717/ 2025-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k251717-freedom-total-knee-system-titanium-fda-510k.jpg K251717 - Freedom® Total Knee System – Titanium Tibial Base Plate K251717 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Maxx Orthopedics, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k251728/ 2025-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k251728-velacur-one-li-1100-fda-510k.jpg K251728 - Velacur One (LI-1100) K251728 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sonic Incytes Medical Corp. Cleared Jun 2025. https://www.510kdatabase.net/k242845/ 2025-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k242845-egis-biliary-double-bare-stent-bdb080405-fda-510k.jpg K242845 - EGIS Biliary Double Bare Stent (BDB080405) K242845 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: S&G Biotech, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k243112/ 2025-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k243112-curapuls-670-fda-510k.jpg K243112 - Curapuls 670 K243112 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Enraf-Nonius, B.V.. Cleared Jun 2025. https://www.510kdatabase.net/k243184/ 2025-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k243184-sat-centerflow-molding-balloon-fda-510k.jpg K243184 - SAT CenterFlow Molding Balloon Catheter (IN20-00313) K243184 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Strait Access Technologies Holdings. Cleared Jun 2025. https://www.510kdatabase.net/k250302/ 2025-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k250302-flexible-partial-resin-fda-510k.jpg K250302 - Flexible Partial Resin K250302 is a FDA 510(k) cleared dental medical device. Manufacturer: Prismatik Dentalcraft, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k250329/ 2025-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k250329-geniphys-collymer-self-assembling-fda-510k.jpg K250329 - GeniPhys Collymer Self-Assembling Scaffold K250329 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Geniphys, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k250747/ 2025-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k250747-globe-pulsed-field-system-fda-510k.jpg K250747 - Globe® Pulsed Field System K250747 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Kardium, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k250774/ 2025-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k250774-sprotte-standard-luer-nrfit-lumbar-fda-510k.jpg K250774 - SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture K250774 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: PAJUNK GmbH Medizintechnologie. Cleared Jun 2025. https://www.510kdatabase.net/k250921/ 2025-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k250921-coriograph-pre-op-planning-and-fda-510k.jpg K250921 - CORIOGRAPH Pre-Op Planning and Modeling Services K250921 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Blue Belt Technologies, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k250943/ 2025-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k250943-sysmex-xr-series-xr-10-automated-fda-510k.jpg K250943 - Sysmex XR-Series (XR-10) Automated Hematology Analyzer K250943 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sysmex America, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k250966/ 2025-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k250966-currentbody-skin-led-light-therapy-fda-510k.jpg K250966 - CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H) K250966 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Kaiyan Medical Equipment Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k251003/ 2025-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k251003-x-pac-llif-expandable-lateral-cage-fda-510k.jpg K251003 - X-PAC® LLIF Expandable Lateral Cage System K251003 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Expanding Innovations, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k251371/ 2025-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k251371-sysmex-xr-series-xr-20-automated-fda-510k.jpg K251371 - Sysmex XR-Series (XR-20) Automated Hematology Analyzer K251371 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sysmex America, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k251606/ 2025-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k251606-power-wheelchair-d26-fda-510k.jpg K251606 - Power Wheelchair (D26) K251606 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Anhui Jbh Medical Apparatus Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k251611/ 2025-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k251611-optiflow-nasal-cannula-small-opt942-fda-510k.jpg K251611 - Optiflow+ Nasal Cannula - Small (OPT942) K251611 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Fisher &Paykel Healthcare , Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k251627/ 2025-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k251627-bioraptor-23-pk-suture-anchor-w-fda-510k.jpg K251627 - BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue) K251627 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k251725/ 2025-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k251725-anax-oct-spinal-system-fda-510k.jpg K251725 - ANAX™ OCT Spinal System K251725 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Cg Medtech Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k243009/ 2025-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k243009-mist-ic-fda-510k.jpg K243009 - MIST IC K243009 is a FDA 510(k) cleared dental medical device. Manufacturer: Imagine Milling Technologies, LLC. Cleared Jun 2025. https://www.510kdatabase.net/k250268/ 2025-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k250268-hypersnap-surgical-system-hss-fda-510k.jpg K250268 - HyperSnap Surgical System (HSS) K250268 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Hypervision Surgical. Cleared Jun 2025. https://www.510kdatabase.net/k250326/ 2025-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k250326-quantum-perfusion-centrifugal-blood-fda-510k.jpg K250326 - Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG) K250326 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Spectrum Medical S.R.L.. Cleared Jun 2025. https://www.510kdatabase.net/k251358/ 2025-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k251358-bridge-plus-occlusion-balloon-590-002-fda-510k.jpg K251358 - Bridge Plus Occlusion Balloon (590-002) K251358 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Philips Image Guided Therapy Devices. Cleared Jun 2025. https://www.510kdatabase.net/k251362/ 2025-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k251362-pediflex-flexible-nail-system-fda-510k.jpg K251362 - PediFlex™ Flexible Nail System K251362 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OrthoPediatrics Corp.. Cleared Jun 2025. https://www.510kdatabase.net/k251644/ 2025-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k251644-proam-alif-system-fda-510k.jpg K251644 - ProAM ALIF System K251644 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Pro Surgical, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k251648/ 2025-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k251648-gps-advanced-fda-510k.jpg K251648 - GPS Advanced K251648 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Prosidyan, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k242924/ 2025-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k242924-opxion-optical-skin-viewer-opxsv1-01f-fda-510k.jpg K242924 - OPXION Optical Skin Viewer (OPXSV1-01F) K242924 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Opxion Technology, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k243142/ 2025-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k243142-cranial-4pi-immobilization-fda-510k.jpg K243142 - Cranial 4Pi Immobilization K243142 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab AG. Cleared Jun 2025. https://www.510kdatabase.net/k243339/ 2025-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k243339-witof-fda-510k.jpg K243339 - WiTOF K243339 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Idmed. Cleared Jun 2025. https://www.510kdatabase.net/k250143/ 2025-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k250143-digital-prism-correction-feature-dpcf-fda-510k.jpg K250143 - Digital Prism Correction Feature (DPCF) K250143 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Apple, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k250470/ 2025-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k250470-ear-thermometer-ear-e101-fda-510k.jpg K250470 - Ear Thermometer (EAR-E101) K250470 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen AOJ Medical Technology Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k250862/ 2025-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k250862-evis-exera-iii-bronchovideoscope-fda-510k.jpg K250862 - EVIS EXERA III BRONCHOVIDEOSCOPE (OLYMPUS BF-XP190) K250862 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Jun 2025. https://www.510kdatabase.net/k250885/ 2025-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k250885-ceftobiprole-bpr-5-g-disc-fda-510k.jpg K250885 - Ceftobiprole BPR 5 µg Disc K250885 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Liofilchem, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k251271/ 2025-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k251271-tempfit-temporary-crown-and-bridge-resin-fda-510k.jpg K251271 - TempFIT Temporary Crown and Bridge Resin K251271 is a FDA 510(k) cleared dental medical device. Manufacturer: Rizhao Huge Biomaterials Company, Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k251570/ 2025-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k251570-hippocampe-marathon-and-trail-fda-510k.jpg K251570 - Hippocampe Marathon and Trail K251570 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Vipamat Sarl. Cleared Jun 2025. https://www.510kdatabase.net/k242843/ 2025-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k242843-the-sensititre-20-24-hour-haemophilus-fda-510k.jpg K242843 - The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL. K242843 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Thermo Fisher Scientific. Cleared Jun 2025. https://www.510kdatabase.net/k242911/ 2025-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k242911-medconn-glycated-hemoglobin-test-system-fda-510k.jpg K242911 - Medconn Glycated Hemoglobin Test system K242911 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Shanghai Medconn Medical Technology Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k242964/ 2025-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k242964-celsi-warmer-fda-510k.jpg K242964 - Celsi Warmer K242964 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hadleigh Health Technologies. Cleared Jun 2025. https://www.510kdatabase.net/k242974/ 2025-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k242974-external-csf-drainage-ventricular-fda-510k.jpg K242974 - External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Catheters K242974 is a FDA 510(k) cleared neurology medical device. Manufacturer: Sophysa. Cleared Jun 2025. https://www.510kdatabase.net/k242981/ 2025-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k242981-atellica-im-thyroglobulin-tg-fda-510k.jpg K242981 - Atellica IM Thyroglobulin (Tg) K242981 is a FDA 510(k) cleared immunology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k242985/ 2025-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k242985-collovine-wound-dressing-fda-510k.jpg K242985 - CollOvine™ Wound Dressing K242985 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ovigenex, LLC. Cleared Jun 2025. https://www.510kdatabase.net/k243000/ 2025-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k243000-reusable-temperature-probe-t1306-t2306-fda-510k.jpg K243000 - Reusable Temperature Probe (T1306, T2306, T3306, T4306) K243000 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen Medke Technology Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k243053/ 2025-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k243053-navient-image-guided-navigation-system-fda-510k.jpg K243053 - Navient Image Guided Navigation System (ENT) (955-NC-NC) K243053 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Claronav. Cleared Jun 2025. https://www.510kdatabase.net/k243062/ 2025-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k243062-bd-intelliport-system-fda-510k.jpg K243062 - BD Intelliport System K243062 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton Dickinson. Cleared Jun 2025. https://www.510kdatabase.net/k243120/ 2025-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k243120-hybridapc-probe-fda-510k.jpg K243120 - HybridAPC probe K243120 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Erbe Elektromedizin GmbH. Cleared Jun 2025. https://www.510kdatabase.net/k243168/ 2025-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k243168-alinity-i-rubella-igg-fda-510k.jpg K243168 - Alinity i Rubella IgG K243168 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Jun 2025. https://www.510kdatabase.net/k243398/ 2025-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k243398-ct-scanner-tsx-501r1-v111-fda-510k.jpg K243398 - CT Scanner TSX-501R/1 V11.1 K243398 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Jun 2025. https://www.510kdatabase.net/k243589/ 2025-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k243589-pal-sterilization-case-fda-510k.jpg K243589 - PAL Sterilization Case K243589 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Microaire Surgical Instruments, LLC. Cleared Jun 2025. https://www.510kdatabase.net/k243978/ 2025-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k243978-led-facial-mask-fda-510k.jpg K243978 - LED Facial Mask K243978 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Sunsred Technology Co.,Ltd. Cleared Jun 2025. https://www.510kdatabase.net/k250037/ 2025-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k250037-incompass-total-ankle-system-fda-510k.jpg K250037 - Incompass Total Ankle System K250037 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wright Medical Technology, Inc. (Stryker). Cleared Jun 2025. https://www.510kdatabase.net/k250151/ 2025-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k250151-us2ca-fda-510k.jpg K250151 - Us2.ca K250151 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Eko.Ai Pte Ltd. D/B/A Us2.Ai. Cleared Jun 2025. https://www.510kdatabase.net/k250566/ 2025-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k250566-escem-rmgi-fda-510k.jpg K250566 - EsCem RMGI K250566 is a FDA 510(k) cleared dental medical device. Manufacturer: Spident Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k250583/ 2025-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k250583-adheresp-smart-breath-actuated-mesh-fda-510k.jpg K250583 - AdheResp Smart Breath-actuated Mesh Nebulizer K250583 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Hcmed Innovations Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k250732/ 2025-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k250732-disposable-endoscopy-valve-set-fda-510k.jpg K250732 - Disposable Endoscopy Valve Set K250732 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Yangzhou Fartley Medical Instrument Technology Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k250877/ 2025-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k250877-tmini-miniature-robotic-system-fda-510k.jpg K250877 - TMINI Miniature Robotic System K250877 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: THINK Surgical, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k250880/ 2025-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k250880-led-light-mask-a093-fda-510k.jpg K250880 - LED LIGHT MASK (A093) K250880 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Foshan Guangyu Weilai Medical Equipment Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k250968/ 2025-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k250968-pathpresenter-clinical-viewer-fda-510k.jpg K250968 - PathPresenter Clinical Viewer K250968 is a FDA 510(k) cleared pathology medical device. Manufacturer: Pathpresenter Corporation. Cleared Jun 2025. https://www.510kdatabase.net/k251114/ 2025-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k251114-flopatch-fp120-fda-510k.jpg K251114 - FloPatch FP120 K251114 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Flosonics Medical. Cleared Jun 2025. https://www.510kdatabase.net/k251224/ 2025-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k251224-restrata-soft-tissue-reinforcement-str-fda-510k.jpg K251224 - Restrata Soft Tissue Reinforcement (STR) K251224 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Acera Surgical, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k251240/ 2025-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k251240-branchor-x-balloon-guide-catheter-fda-510k.jpg K251240 - Branchor X Balloon Guide Catheter K251240 is a FDA 510(k) cleared neurology medical device. Manufacturer: Asahi Intecc Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k251248/ 2025-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k251248-electric-wheelchair-qdwp-a01qdwp-b02-fda-510k.jpg K251248 - ELECTRIC WHEELCHAIR (QDWP-A01,QDWP-B02) K251248 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Jinhua Qidian Vehicle Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k251258/ 2025-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k251258-mc2-two-stage-venous-cannula-fda-510k.jpg K251258 - MC2™ Two-Stage Venous Cannula K251258 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k251560/ 2025-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k251560-fubuki-xf-r-neurovascular-long-sheath-fda-510k.jpg K251560 - FUBUKI XF-R Neurovascular Long Sheath K251560 is a FDA 510(k) cleared neurology medical device. Manufacturer: Asahi Intecc Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k251567/ 2025-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k251567-novosorb-btm-fda-510k.jpg K251567 - NovoSorb BTM K251567 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Polynovo Biomaterials Pty, Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k242944/ 2025-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k242944-leone-orthodontic-implant-tad-fda-510k.jpg K242944 - Leone Orthodontic Implant TAD (Temporary Anchorage Device) K242944 is a FDA 510(k) cleared dental medical device. Manufacturer: Leone S.P.A.. Cleared Jun 2025. https://www.510kdatabase.net/k250515/ 2025-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k250515-epimonitor-fda-510k.jpg K250515 - EpiMonitor K250515 is a FDA 510(k) cleared neurology medical device. Manufacturer: Empatica S.R.L.. Cleared Jun 2025. https://www.510kdatabase.net/k251235/ 2025-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k251235-electrosurgical-pads-fda-510k.jpg K251235 - Electrosurgical Pads K251235 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Baisheng Medical Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k242224/ 2025-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k242224-happy-health-home-sleep-test-fda-510k.jpg K242224 - Happy Health Home Sleep Test K242224 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Happy Health, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k242894/ 2025-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k242894-sanagile-ultrasonic-surgery-advanced-fda-510k.jpg K242894 - SanAgile™ Ultrasonic Surgery Advanced Portable Controller (SA10) K242894 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shanghai Saints Sages Surgical Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k242917/ 2025-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k242917-enteral-drainage-system-enteral-fda-510k.jpg K242917 - Enteral Drainage System, Enteral Medicine straw K242917 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hmc Premedical S.P.A.. Cleared Jun 2025. https://www.510kdatabase.net/k242922/ 2025-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k242922-extracorporeal-shock-wave-lithotripter-fda-510k.jpg K242922 - Extracorporeal Shock Wave Lithotripter (U200) K242922 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Shenzhen Wikkon Precision Technologies Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k242933/ 2025-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k242933-spineart-navigation-instrument-system-fda-510k.jpg K242933 - SPINEART Navigation Instrument System K242933 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spineart SA. Cleared Jun 2025. https://www.510kdatabase.net/k243014/ 2025-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k243014-eyeq-nanoecp-fda-510k.jpg K243014 - EyeQ nanoECP K243014 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Eyeq, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k243039/ 2025-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k243039-ureteral-stents-af-d-series-fda-510k.jpg K243039 - Ureteral Stents (AF-D series) K243039 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Alton (Shanghai) Medical Instruments Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k243102/ 2025-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k243102-mobility-scooter-jt10-fda-510k.jpg K243102 - Mobility Scooter (JT10) K243102 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Jiangxi Jiangte Electric Vehicle Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k243172/ 2025-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k243172-halyard-purple-nitrile-powder-free-fda-510k.jpg K243172 - Halyard Purple Nitrile* Powder-Free Exam Gloves, Sterile Pairs K243172 is a FDA 510(k) cleared general hospital medical device. Manufacturer: O&M Halyard, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k243253/ 2025-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k243253-6600-ultrasound-system-mylaba50-fda-510k.jpg K243253 - 6600 Ultrasound System (MyLabA50) K243253 is a FDA 510(k) cleared radiology medical device. Manufacturer: Esaote, S.P.A.. Cleared Jun 2025. https://www.510kdatabase.net/k243366/ 2025-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k243366-drx9000c-sl-cervical-spinal-fda-510k.jpg K243366 - DRX9000C-SL Cervical Spinal Decompression System K243366 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Excite Medical of Tampa Bay, LLC. Cleared Jun 2025. https://www.510kdatabase.net/k243583/ 2025-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k243583-fp-nova-nasal-mask-fda-510k.jpg K243583 - F&P Nova Nasal Mask K243583 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Fisher & Paykel Healthcare Limited. Cleared Jun 2025. https://www.510kdatabase.net/k243672/ 2025-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k243672-cardiq-suite-fda-510k.jpg K243672 - CardIQ Suite K243672 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems SCS. Cleared Jun 2025. https://www.510kdatabase.net/k250082/ 2025-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k250082-procedure-masksurgical-maskface-mask-fda-510k.jpg K250082 - Procedure mask/Surgical mask/Face mask K250082 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Winner Medical Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k250492/ 2025-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k250492-flexigo-3d-delivery-catheter-fda-510k.jpg K250492 - FlexiGo 3D Delivery Catheter K250492 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: CenterPoint Systems, LLC. Cleared Jun 2025. https://www.510kdatabase.net/k250845/ 2025-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k250845-curiteva-porous-peek-standalone-alif-fda-510k.jpg K250845 - Curiteva Porous PEEK Standalone ALIF System K250845 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Curiteva, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k250872/ 2025-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k250872-bioline-dental-implant-system-fda-510k.jpg K250872 - Bioline Dental Implant System K250872 is a FDA 510(k) cleared dental medical device. Manufacturer: Bioline Dental Implant Systems, Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k250886/ 2025-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k250886-epiq-series-diagnostic-ultrasound-fda-510k.jpg K250886 - EPIQ Series Diagnostic Ultrasound Systems K250886 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Ultrasound, LLC. Cleared Jun 2025. https://www.510kdatabase.net/k250908/ 2025-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k250908-virata-spinal-fixation-system-fda-510k.jpg K250908 - Virata Spinal Fixation System K250908 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared Jun 2025. https://www.510kdatabase.net/k251253/ 2025-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k251253-powerport-isp-implantable-port-fda-510k.jpg K251253 - PowerPort™ isp Implantable Port K251253 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bard Access Systems, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k251296/ 2025-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k251296-the-acumed-wrist-fixation-system-fda-510k.jpg K251296 - The Acumed Wrist Fixation System K251296 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Acumed, LLC. Cleared Jun 2025. https://www.510kdatabase.net/k251530/ 2025-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k251530-conmed-argo-knotless-anchor-fda-510k.jpg K251530 - CONMED Argo Knotless® Anchor K251530 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Conmed Corporation. Cleared Jun 2025. https://www.510kdatabase.net/k251634/ 2025-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k251634-lzi-fentanyl-iii-enzyme-immunoassay-fda-510k.jpg K251634 - LZI Fentanyl III Enzyme Immunoassay K251634 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Lin-Zhi International, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k243003/ 2025-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k243003-vitalsigns-1-lead-holter-vsh101-fda-510k.jpg K243003 - VitalSigns 1-Lead Holter (VSH101) K243003 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: VitalSigns Technology Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k243133/ 2025-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k243133-nitrile-powder-free-examination-gloves-fda-510k.jpg K243133 - Nitrile Powder Free Examination Gloves with Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid K243133 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Kl-Kepong Rubber Products Sdn. Bhd.. Cleared Jun 2025. https://www.510kdatabase.net/k243561/ 2025-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k243561-nano-check-influenzacovid-19-dual-test-fda-510k.jpg K243561 - Nano-Check Influenza+COVID-19 Dual Test K243561 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Nano-Ditech Corporation. Cleared Jun 2025. https://www.510kdatabase.net/k243618/ 2025-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k243618-easislush-sodium-chloride-solution-for-fda-510k.jpg K243618 - EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) K243618 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Bridge TO Life. Cleared Jun 2025. https://www.510kdatabase.net/k243666/ 2025-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k243666-uomniscan-fda-510k.jpg K243666 - uOmniscan K243666 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k243880/ 2025-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k243880-shear-wave-quantificational-ultrasound-fda-510k.jpg K243880 - Shear Wave Quantificational Ultrasound Diagnostic System (Mini900, Mini990, Mini800, Mini790, Mini780, Mini560, Mini300, Mini100, FT100) K243880 is a FDA 510(k) cleared radiology medical device. Manufacturer: Wuxi Hisky Medical Technologies Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k250219/ 2025-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k250219-dorado-pta-balloon-dilatation-catheter-fda-510k.jpg K250219 - Dorado™ PTA Balloon Dilatation Catheter K250219 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bard Peripheral Vascular, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k250440/ 2025-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k250440-rt-elements-45-fda-510k.jpg K250440 - RT Elements (4.5) K250440 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab AG. Cleared Jun 2025. https://www.510kdatabase.net/k250665/ 2025-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k250665-skr-3000-fda-510k.jpg K250665 - SKR 3000 K250665 is a FDA 510(k) cleared radiology medical device. Manufacturer: Konica Minolta, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k250997/ 2025-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k250997-integrity-implant-fda-510k.jpg K250997 - Integrity™ Implant K250997 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Anika Therapeutics, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k251017/ 2025-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k251017-currentbody-skin-dual-light-hair-fda-510k.jpg K251017 - CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A) K251017 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Kaiyan Medical Equipment Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/den240038/ 2025-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/den240038-oxiplex-fda-510k.jpg DEN240038 - Oxiplex® DEN240038 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Fziomed, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/den240066/ 2025-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/den240066-coaptium-connect-with-tissium-light-fda-510k.jpg DEN240066 - COAPTIUM Connect with TISSIUM LIGHT DEN240066 is a FDA 510(k) cleared neurology medical device. Manufacturer: Tissium SA. Cleared Jun 2025. https://www.510kdatabase.net/k242870/ 2025-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k242870-access-hstni-fda-510k.jpg K242870 - Access hsTnI K242870 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k242978/ 2025-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k242978-geo-abutment-fda-510k.jpg K242978 - Geo Abutment K242978 is a FDA 510(k) cleared dental medical device. Manufacturer: Geomedi Co,., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k243011/ 2025-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k243011-silicone-urethral-catheter-silicone-fda-510k.jpg K243011 - Silicone Urethral Catheter (Silicone Urethral Catheter) K243011 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Guangdong Ecan Medical Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k243872/ 2025-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k243872-bd-veritor-system-for-sars-cov-2-fda-510k.jpg K243872 - BD Veritor System for SARS-CoV-2 K243872 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson and Company. Cleared Jun 2025. https://www.510kdatabase.net/k244012/ 2025-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k244012-mosaic-v101-fda-510k.jpg K244012 - Mosaic (V1.0.1) K244012 is a FDA 510(k) cleared radiology medical device. Manufacturer: Navier Medical. Cleared Jun 2025. https://www.510kdatabase.net/k250436/ 2025-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k250436-magnetom-flowace-fda-510k.jpg K250436 - MAGNETOM Flow.Ace K250436 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Shenzhen Magnetic Resonance , Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k250443/ 2025-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k250443-magnetom-avanto-fit-fda-510k.jpg K250443 - MAGNETOM Avanto Fit K250443 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Healthcare GmbH. Cleared Jun 2025. https://www.510kdatabase.net/k250685/ 2025-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k250685-methinks-ncct-stroke-fda-510k.jpg K250685 - Methinks NCCT Stroke K250685 is a FDA 510(k) cleared radiology medical device. Manufacturer: Methinks Software, S.L. Cleared Jun 2025. https://www.510kdatabase.net/k250900/ 2025-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k250900-evoendo-single-use-endoscopy-system-fda-510k.jpg K250900 - EvoEndo Single-Use Endoscopy System K250900 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: EvoEndo, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k251617/ 2025-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k251617-x-pac-tlif-expandable-posterior-cage-fda-510k.jpg K251617 - X-PAC® TLIF Expandable Posterior Cage System K251617 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Expanding Innovations, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k240795/ 2025-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k240795-withings-ecg-app-fda-510k.jpg K240795 - Withings ECG App K240795 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Withings. Cleared Jun 2025. https://www.510kdatabase.net/k242863/ 2025-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k242863-bioptimal-bipolar-pacing-catheter-fda-510k.jpg K242863 - Bioptimal Bipolar Pacing Catheter K242863 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bioptimal International Pte. , Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k243036/ 2025-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k243036-ipl-hair-removal-device-bhrl-01-bhrl-fda-510k.jpg K243036 - IPL Hair Removal Device (BHRL-01, BHRL-02, BHRL-03, BHRL-04, BHRL-05, BHRL-06, BHRL-06B, BHRL-07, BHRL-08, BHRL-09, BHRL-10, BHRL-11, BHRL-12, BHRL-13, BHRL-14, BHRL-15, BHRL-16, BHRL-17, BHRL-18, BHRL-19, BHRL-20, BHRL-21, BHRL-22, BHRL-23, BHRL-24, BHRL-25, BHRL-26, BHRL-27, BHRL-28, BHRL-29) K243036 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bestway Plastic and Metal Products , Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k242852/ 2025-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k242852-alm-tube-id-60-od-82-520843-alm-tube-fda-510k.jpg K242852 - ALM Tube I.D. 6.0, O.D. 8.2 (520843), ALM Tube I.D. 7.0, O.D. 9.7 (520845), ALM Tube I.D. 7.5, O.D. 10.3 (520846), ALM Tube I.D. 8.0, O.D. 11.0 (520847) K242852 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Inomed Medizintechnik GmbH. Cleared Jun 2025. https://www.510kdatabase.net/k243237/ 2025-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k243237-2008t-hd-sys-cdx-bluestar-191124-fda-510k.jpg K243237 - 2008T HD SYS. CDX BLUESTAR (191124) K243237 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC. Cleared Jun 2025. https://www.510kdatabase.net/k243633/ 2025-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k243633-brainlab-elements-70-fda-510k.jpg K243633 - Brainlab Elements (7.0) K243633 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab AG. Cleared Jun 2025. https://www.510kdatabase.net/k243638/ 2025-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k243638-mv-flow-aspiration-pump-mvflowpmp01-fda-510k.jpg K243638 - MV Flow Aspiration Pump (MVFLOWPMP01) K243638 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Microvention. Cleared Jun 2025. https://www.510kdatabase.net/k243729/ 2025-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k243729-prismira-fda-510k.jpg K243729 - Prismira K243729 is a FDA 510(k) cleared neurology medical device. Manufacturer: Lumos Labs, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k244017/ 2025-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k244017-fujifilm-endoscope-model-eb-710p-fda-510k.jpg K244017 - FUJIFILM Endoscope Model EB-710P K244017 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Fujifilm Corporation. Cleared Jun 2025. https://www.510kdatabase.net/k250075/ 2025-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k250075-medtronic-stedi-extra-support-guidewire-fda-510k.jpg K250075 - Medtronic Stedi Extra Support Guidewire K250075 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k250251/ 2025-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k250251-eleganz-fusion-screw-system-fusion-fda-510k.jpg K250251 - Eleganz Fusion Screw System (Fusion Screw System) K250251 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Dev4. Cleared Jun 2025. https://www.510kdatabase.net/k250273/ 2025-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k250273-binaxnow-covid-19-ag-card-fda-510k.jpg K250273 - BinaxNOW COVID-19 Ag Card K250273 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Diagnostics Scarborough, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k250469/ 2025-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k250469-accuro-3s-needle-guide-kit-fda-510k.jpg K250469 - Accuro® 3S Needle Guide Kit K250469 is a FDA 510(k) cleared radiology medical device. Manufacturer: Rivanna Medical, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k250674/ 2025-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k250674-vessel-sealer-curved-480522-fda-510k.jpg K250674 - Vessel Sealer Curved (480522) K250674 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k250759/ 2025-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k250759-3-in-1-tens-unit-fda-510k.jpg K250759 - 3 in 1 TENS UNIT K250759 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Changsha Anxiang Medical Technology Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k251166/ 2025-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k251166-mfinity-femoral-system-fda-510k.jpg K251166 - Mfinity Femoral System K251166 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Jun 2025. https://www.510kdatabase.net/k251189/ 2025-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k251189-aventus-thrombectomy-system-fda-510k.jpg K251189 - Aventus Thrombectomy System K251189 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inquis Medical. Cleared Jun 2025. https://www.510kdatabase.net/k251485/ 2025-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k251485-excipio-lv-prime-thrombectomy-device-fda-510k.jpg K251485 - Excipio LV Prime Thrombectomy Device K251485 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Contego Medical, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k242865/ 2025-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k242865-synicem-hip-spacer-fda-510k.jpg K242865 - Synicem Hip Spacer K242865 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biocomposites, Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k242872/ 2025-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k242872-idart-lyme-igm-immunoblot-kit-fda-510k.jpg K242872 - iDart Lyme IgM ImmunoBlot Kit K242872 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Id-Fish Technology, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k243234/ 2025-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k243234-second-opinion-cs-fda-510k.jpg K243234 - Second Opinion® CS K243234 is a FDA 510(k) cleared radiology medical device. Manufacturer: Pearl, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k243608/ 2025-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k243608-trigen-stable-lock-nut-washer-fda-510k.jpg K243608 - TRIGEN Stable Lock Nut & Washer K243608 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k243683/ 2025-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k243683-deka-bluebeam-fda-510k.jpg K243683 - Deka Bluebeam K243683 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: El.En S.P.A.. Cleared Jun 2025. https://www.510kdatabase.net/k243973/ 2025-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k243973-fix-l-peek-plif-and-t-plif-system-fda-510k.jpg K243973 - FIX-L PEEK PLIF and T-PLIF System K243973 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Jeil Medical Corporation. Cleared Jun 2025. https://www.510kdatabase.net/k250559/ 2025-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k250559-gmreis-fibula-nail-system-fda-510k.jpg K250559 - GMReis Fibula Nail System K250559 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Gm Dos Reis Industria E Comercio. Cleared Jun 2025. https://www.510kdatabase.net/k250782/ 2025-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k250782-fractional-co2-laser-machine-fda-510k.jpg K250782 - Fractional CO2 Laser Machine K250782 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Zhengzhou PZ Laser Slim Technology Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k250789/ 2025-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k250789-thermo-scientific-oxoid-fda-510k.jpg K250789 - Thermo Scientific Oxoid Aztreonam/Avibactam Disc (30/20 µg) AZA50 K250789 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Thermo Fisher Scientific (Oxoid Ltd.). Cleared Jun 2025. https://www.510kdatabase.net/k250826/ 2025-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k250826-multi-m-series-fda-510k.jpg K250826 - Multi M Series K250826 is a FDA 510(k) cleared dental medical device. Manufacturer: Dmax Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k250856/ 2025-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k250856-etest-aztreonamavibactam-aza-00164-fda-510k.jpg K250856 - ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL) K250856 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Biom?rieux. Cleared Jun 2025. https://www.510kdatabase.net/k250936/ 2025-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k250936-q-switched-ndyag-laser-she-lsp101-1-fda-510k.jpg K250936 - Q-Switched Nd:YAG Laser (SHE-LSP101-1) K250936 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Beijing Sano Laser S&T Development Co.,Ltd. Cleared Jun 2025. https://www.510kdatabase.net/k251153/ 2025-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k251153-aurora-fda-510k.jpg K251153 - Aurora K251153 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems Israel. Cleared Jun 2025. https://www.510kdatabase.net/k251154/ 2025-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k251154-riva-posterior-fixation-system-fda-510k.jpg K251154 - RIVA Posterior Fixation System K251154 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ht Medical D.B.A. Xenix Medical. Cleared Jun 2025. https://www.510kdatabase.net/k251193/ 2025-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k251193-grafton-dbm-fda-510k.jpg K251193 - Grafton™ DBM K251193 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k251209/ 2025-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k251209-medical-monitor-32hs710s-fda-510k.jpg K251209 - Medical Monitor (32HS710S) K251209 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lg Electronics.Inc. Cleared Jun 2025. https://www.510kdatabase.net/k251279/ 2025-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k251279-disposable-cytology-brush-bc-202d203d-fda-510k.jpg K251279 - Disposable Cytology Brush BC-202D/203D Series K251279 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Olympus Medical Systems Corporation. Cleared Jun 2025. https://www.510kdatabase.net/k251459/ 2025-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k251459-onelif-interbody-fusion-system-fda-510k.jpg K251459 - OneLIF™ Interbody Fusion System K251459 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Novapproach Spine, LLC. Cleared Jun 2025. https://www.510kdatabase.net/k251557/ 2025-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k251557-bard-mesh-fda-510k.jpg K251557 - Bard® Mesh K251557 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Davol, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/den240032/ 2025-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/den240032-apo-easy-genotyping-kit-fda-510k.jpg DEN240032 - APO-Easy Genotyping kit DEN240032 is a FDA 510(k) cleared immunology medical device. Manufacturer: Firalis SA. Cleared Jun 2025. https://www.510kdatabase.net/k240852/ 2025-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k240852-da-vinci-x-surgical-system-is4200-fda-510k.jpg K240852 - da Vinci X Surgical System (IS4200) K240852 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k242801/ 2025-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k242801-micor-700-system-na-fda-510k.jpg K242801 - MICOR 700 System (N/A) K242801 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Carl Zeiss Meditec Cataract Technology, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k243482/ 2025-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k243482-self-forming-magnet-flexagon-fda-510k.jpg K243482 - Self-Forming Magnet (Flexagon) K243482 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: GI Windows, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k250269/ 2025-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k250269-ambu-ascope-5-cysto-hd-standard-fda-510k.jpg K250269 - Ambu® aScope™ 5 Cysto HD (Standard Deflection) K250269 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ambu A/S. Cleared Jun 2025. https://www.510kdatabase.net/k250584/ 2025-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k250584-rezum-system-fda-510k.jpg K250584 - Rezum System K250584 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Jun 2025. https://www.510kdatabase.net/k250646/ 2025-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k250646-impact-peek-union-nail-system-fda-510k.jpg K250646 - Impact PEEK Union Nail System K250646 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nvision Biomedical Technologies. Cleared Jun 2025. https://www.510kdatabase.net/k250710/ 2025-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k250710-injectable-root-canal-bioceramic-fda-510k.jpg K250710 - Injectable Root Canal Bioceramic Sealer (nRoot SP) K250710 is a FDA 510(k) cleared dental medical device. Manufacturer: Enpuno Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k250787/ 2025-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k250787-liberant-thrombectomy-system-fda-510k.jpg K250787 - Liberant Thrombectomy System K250787 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Ireland. Cleared Jun 2025. https://www.510kdatabase.net/k250933/ 2025-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k250933-lorraine-2535mm-distal-humerus-system-fda-510k.jpg K250933 - LORRAINE 2.5/3.5mm Distal Humerus System K250933 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Bonebridge AG. Cleared Jun 2025. https://www.510kdatabase.net/k251499/ 2025-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k251499-frova-intubating-introducer-c-cae-140-fda-510k.jpg K251499 - Frova Intubating Introducer (C-CAE-14.0-70-FII) K251499 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: William Cook Europe Aps. Cleared Jun 2025. https://www.510kdatabase.net/k242921/ 2025-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k242921-5300600-5301000-rota-trach-disposable-fda-510k.jpg K242921 - 5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm K242921 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Vitaltec Corporation. Cleared Jun 2025. https://www.510kdatabase.net/k242996/ 2025-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k242996-endymed-pro-max-fda-510k.jpg K242996 - EndyMed PRO MAX K242996 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Endymed Medical, Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k243512/ 2025-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k243512-fujifilm-endoscope-model-eg-840n-fda-510k.jpg K243512 - FUJIFILM Endoscope Model EG-840N K243512 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fujifilm Corporation. Cleared Jun 2025. https://www.510kdatabase.net/k243956/ 2025-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k243956-tg-980p-co2-sensor-kit-tg-980p-fda-510k.jpg K243956 - TG-980P CO2 Sensor Kit (TG-980P) K243956 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Nihon Kohden Corporation. Cleared Jun 2025. https://www.510kdatabase.net/k250010/ 2025-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k250010-extron-3-fda-510k.jpg K250010 - EXTRON 3 K250010 is a FDA 510(k) cleared radiology medical device. Manufacturer: DRTECH Corporation. Cleared Jun 2025. https://www.510kdatabase.net/k250354/ 2025-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k250354-viz-subdural-viz-subdural-plus-fda-510k.jpg K250354 - Viz Subdural+, Viz SUBDURAL PLUS K250354 is a FDA 510(k) cleared radiology medical device. Manufacturer: Viz. Ai, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k250735/ 2025-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k250735-dental-barrier-and-sleeves-fda-510k.jpg K250735 - Dental Barrier and Sleeves K250735 is a FDA 510(k) cleared dental medical device. Manufacturer: Fomed Industries, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k250768/ 2025-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k250768-elecsys-anti-sars-cov-2-fda-510k.jpg K250768 - Elecsys Anti-SARS-CoV-2 K250768 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Diagnostics. Cleared Jun 2025. https://www.510kdatabase.net/k250465/ 2025-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k250465-co2-laser-machine-lume-fda-510k.jpg K250465 - CO2 Laser Machine (Lume) K250465 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Nanjing Bestview Laser S&T Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k250830/ 2025-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k250830-led-light-therapy-mask-g15-g15p-g15k-fda-510k.jpg K250830 - LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK) K250830 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Sungrow Led Technology Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k251093/ 2025-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k251093-bonvadis-fda-510k.jpg K251093 - Bonvadis® K251093 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Oneness Biotech Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k251500/ 2025-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k251500-mallyag-injection-pen-adapter-mallyag-fda-510k.jpg K251500 - MallyaG Injection Pen Adapter (MallyaG) K251500 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Biocorp Production. Cleared Jun 2025. https://www.510kdatabase.net/k250746/ 2025-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k250746-magnetic-surgical-system-fda-510k.jpg K250746 - Magnetic Surgical System K250746 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Levita Magnetics International Corp. Cleared Jun 2025. https://www.510kdatabase.net/k240983/ 2025-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k240983-discovery-pico-fda-510k.jpg K240983 - Discovery Pico K240983 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Quanta System Spa. Cleared Jun 2025. https://www.510kdatabase.net/k242431/ 2025-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k242431-omnia-medical-psif-dna-system-fda-510k.jpg K242431 - Omnia Medical PsiF DNA™ System K242431 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Omnia Medical, LLC. Cleared Jun 2025. https://www.510kdatabase.net/k242737/ 2025-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k242737-empatica-health-monitoring-platform-fda-510k.jpg K242737 - Empatica Health Monitoring Platform K242737 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Empatica S.R.L.. Cleared Jun 2025. https://www.510kdatabase.net/k242759/ 2025-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k242759-geister-k-rex-rongeurs-fda-510k.jpg K242759 - Geister K-Rex rongeurs K242759 is a FDA 510(k) cleared neurology medical device. Manufacturer: Geister Medizin Technik GmbH. Cleared Jun 2025. https://www.510kdatabase.net/k242774/ 2025-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k242774-spydrblade-flex-instrument-prd-rg1-001-fda-510k.jpg K242774 - SpydrBlade Flex Instrument (PRD-RG1-001) K242774 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Creo Medical, Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k242907/ 2025-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k242907-delphi-system-fda-510k.jpg K242907 - DELPHI System K242907 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: CnS Medical Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k243002/ 2025-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k243002-mba-biotech-implant-system-fda-510k.jpg K243002 - MBA Biotech Implant System K243002 is a FDA 510(k) cleared dental medical device. Manufacturer: MBA Biotech Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k243456/ 2025-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k243456-onvoy-acetabular-system-fda-510k.jpg K243456 - ONVOY™ Acetabular System K243456 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k243490/ 2025-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k243490-liaison-plex-gram-positive-blood-fda-510k.jpg K243490 - LIAISON PLEX Gram-Positive Blood Culture Assay K243490 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Luminex Corporation. Cleared Jun 2025. https://www.510kdatabase.net/k243550/ 2025-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k243550-karl-storz-flexible-video-uretero-fda-510k.jpg K243550 - KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) K243550 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Karl Storz SE & CO. KG. Cleared Jun 2025. https://www.510kdatabase.net/k243694/ 2025-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k243694-nitrile-powder-free-examination-glove-fda-510k.jpg K243694 - Nitrile Powder Free Examination Glove with Tremella Fuciformis Extract, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate - Blue K243694 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Mah Sing Healthcare Sdn. Bhd.. Cleared Jun 2025. https://www.510kdatabase.net/k243994/ 2025-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k243994-steam-sterilizer-2545d-fda-510k.jpg K243994 - Steam Sterilizer (2545D) K243994 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ningbo Ican Machines Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k250109/ 2025-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k250109-tybr-collagen-gel-fda-510k.jpg K250109 - TYBR Collagen Gel K250109 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tybr Health. Cleared Jun 2025. https://www.510kdatabase.net/k250321/ 2025-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k250321-gci-sterilization-wrappers-fda-510k.jpg K250321 - GCI Sterilization Wrappers K250321 is a FDA 510(k) cleared general hospital medical device. Manufacturer: George Courey, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k250591/ 2025-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k250591-anovo-surgical-system-6ne-fda-510k.jpg K250591 - Anovo Surgical System (6Ne) K250591 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Momentis Surgical , Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k250722/ 2025-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k250722-nd-yag-laser-therapy-system-qn-1-fda-510k.jpg K250722 - Nd: YAG Laser Therapy System (QN-1) K250722 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Hebei JT Medical Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k250891/ 2025-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k250891-cure-catheter-insertion-kit-k1-fda-510k.jpg K250891 - Cure Catheter Insertion Kit (K1) K250891 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Convatec Limited. Cleared Jun 2025. https://www.510kdatabase.net/k251009/ 2025-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k251009-cirrus-resting-state-fmri-software-fda-510k.jpg K251009 - Cirrus Resting State fMRI Software K251009 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sora Neuroscience, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k251042/ 2025-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k251042-light-therapy-system-m500-l6-fda-510k.jpg K251042 - Light Therapy System (M500, L6) K251042 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Guangzhou Ahead Intelligent Technology Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k251131/ 2025-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k251131-annex-2-adjacent-level-system-fda-510k.jpg K251131 - Annex® 2 Adjacent Level System K251131 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spine Wave, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k251283/ 2025-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k251283-once-fil-flow-fda-510k.jpg K251283 - Once-Fil Flow K251283 is a FDA 510(k) cleared dental medical device. Manufacturer: Mediclus Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k251450/ 2025-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k251450-baby-nasal-aspirator-bn002-fda-510k.jpg K251450 - Baby Nasal Aspirator (BN002) K251450 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Shenzhen Desida Technology Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k251452/ 2025-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k251452-celerity-5-hp-biological-indicator-fda-510k.jpg K251452 - Celerity 5 HP Biological Indicator (LCB052) K251452 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Steris. Cleared Jun 2025. https://www.510kdatabase.net/k251525/ 2025-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k251525-si-technology-si-desis-x-sacroiliac-fda-510k.jpg K251525 - SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System K251525 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Si-Technology, LLC. Cleared Jun 2025. https://www.510kdatabase.net/k242464/ 2025-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k242464-stealth-spine-clamps-fda-510k.jpg K242464 - Stealth™ Spine Clamps K242464 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Navigation, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k242704/ 2025-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k242704-synchrony-20-3000-fda-510k.jpg K242704 - Synchrony (20-3000) K242704 is a FDA 510(k) cleared neurology medical device. Manufacturer: Synapse Biomedical, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k242736/ 2025-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k242736-portable-oxygen-concentrator-spirit-3-fda-510k.jpg K242736 - Portable Oxygen Concentrator (Spirit-3) K242736 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Jiangsu Yuyue Medical Equipment& Supply Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k242744/ 2025-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k242744-trinity-evo-acetabular-shell-fda-510k.jpg K242744 - Trinity EVO Acetabular Shell K242744 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corin U.S.A. Limited. Cleared Jun 2025. https://www.510kdatabase.net/k242750/ 2025-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k242750-central-station-fda-510k.jpg K242750 - Central Station K242750 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden Digital Health Solutions, LLC. Cleared Jun 2025. https://www.510kdatabase.net/k243639/ 2025-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k243639-portare-system-fa-001-fda-510k.jpg K243639 - Portare System (FA-001) K243639 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Grumpy Innovation, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k243667/ 2025-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k243667-sonic-dl-fda-510k.jpg K243667 - Sonic DL K243667 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems, LLC. Cleared Jun 2025. https://www.510kdatabase.net/k243703/ 2025-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k243703-techlive-fda-510k.jpg K243703 - TechLive K243703 is a FDA 510(k) cleared radiology medical device. Manufacturer: DeepHealth, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k250467/ 2025-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k250467-red-light-hair-growth-cap-lp-rjvgrw-blk-fda-510k.jpg K250467 - Red Light Hair Growth Cap (LP-RJVGRW-BLK) K250467 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Idea Light Limited. Cleared Jun 2025. https://www.510kdatabase.net/k250545/ 2025-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k250545-medline-renewal-reprocessed-biosense-fda-510k.jpg K250545 - Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG) K250545 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Surgical Instrument Service and Savings, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k250616/ 2025-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k250616-clave-neutral-displacement-needlefree-fda-510k.jpg K250616 - Clave™ Neutral-Displacement Needlefree Connectors K250616 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Icu Medical, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k250701/ 2025-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k250701-evis-exera-iii-duodenovideoscope-fda-510k.jpg K250701 - Evis Exera III Duodenovideoscope Olympus TJF-Q190V (TJF-Q190V) K250701 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Jun 2025. https://www.510kdatabase.net/k250800/ 2025-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k250800-uronav-4-fda-510k.jpg K250800 - UroNav 4 K250800 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips DS North America, LLC. Cleared Jun 2025. https://www.510kdatabase.net/k251084/ 2025-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k251084-zirkon-fda-510k.jpg K251084 - zirkon K251084 is a FDA 510(k) cleared dental medical device. Manufacturer: Estetic Ceram AG. Cleared Jun 2025. https://www.510kdatabase.net/k251456/ 2025-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k251456-brightheart-view-classifier-fda-510k.jpg K251456 - BrightHeart View Classifier K251456 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brightheart. Cleared Jun 2025. https://www.510kdatabase.net/k240788/ 2025-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k240788-ultrasound-stimulator-fda-510k.jpg K240788 - Ultrasound Stimulator K240788 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Jkh Health Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k241433/ 2025-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k241433-eve-synergy-eve-20m-fda-510k.jpg K241433 - EVE Synergy (EVE-20M) K241433 is a FDA 510(k) cleared neurology medical device. Manufacturer: Weero Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k242712/ 2025-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k242712-lubrizenzs-fda-510k.jpg K242712 - LubriZenzs K242712 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Sk Zen, LLC. Cleared Jun 2025. https://www.510kdatabase.net/k243368/ 2025-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k243368-montblanc-plate-system-fda-510k.jpg K243368 - Montblanc Plate System K243368 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medifield Medical Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k243499/ 2025-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k243499-ng-test-ctx-m-multi-fda-510k.jpg K243499 - NG-Test® CTX-M MULTI K243499 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Ng Biotech. Cleared Jun 2025. https://www.510kdatabase.net/k243810/ 2025-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k243810-traumacad-neo-11-fda-510k.jpg K243810 - TraumaCad Neo (1.1) K243810 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab , Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k243843/ 2025-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k243843-tendon-protect-50242-fda-510k.jpg K243843 - Tendon Protect (50242) K243843 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Kerecis Limited. Cleared Jun 2025. https://www.510kdatabase.net/k250118/ 2025-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k250118-disposable-balloon-catheter-b5-2c-fda-510k.jpg K250118 - Disposable Balloon Catheter B5-2C K250118 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Olympus Medical Systems Corporation. Cleared Jun 2025. https://www.510kdatabase.net/k250259/ 2025-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k250259-telerehab-aermos-cardiopulmonary-fda-510k.jpg K250259 - TeleRehab Aermos Cardiopulmonary Rehabilitation K250259 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: The ScottCare Corporation. Cleared Jun 2025. https://www.510kdatabase.net/k250749/ 2025-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k250749-physcade-system-fda-510k.jpg K250749 - PhysCade System K250749 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Physcade, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k250804/ 2025-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k250804-id-light-cure-system-fda-510k.jpg K250804 - ID LIGHT CURE SYSTEM K250804 is a FDA 510(k) cleared dental medical device. Manufacturer: Id Korea Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k250879/ 2025-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k250879-paradigm-system-fda-510k.jpg K250879 - Paradigm System K250879 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Proprio, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k250961/ 2025-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k250961-blood-collection-tube-holders-fda-510k.jpg K250961 - Blood collection tube holders K250961 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Promisemed Hangzhou Meditech Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k251216/ 2025-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k251216-0184-co2-sampling-line-fda-510k.jpg K251216 - 0184 CO2 Sampling line K251216 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Barbaras Development, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k251397/ 2025-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k251397-ingenia-ingenia-cx-ingenia-elition-fda-510k.jpg K251397 - Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System K251397 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Jun 2025. https://www.510kdatabase.net/k251433/ 2025-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k251433-surgify-halo-54085shdh1-fda-510k.jpg K251433 - Surgify Halo (54.085.SHD.H1) K251433 is a FDA 510(k) cleared neurology medical device. Manufacturer: Surgify Medical OY. Cleared Jun 2025. https://www.510kdatabase.net/k242897/ 2025-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k242897-partial-flex-fda-510k.jpg K242897 - Partial Flex K242897 is a FDA 510(k) cleared dental medical device. Manufacturer: Clemde SA DE CV. Cleared Jun 2025. https://www.510kdatabase.net/k243205/ 2025-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k243205-evac-fda-510k.jpg K243205 - EVAC K243205 is a FDA 510(k) cleared neurology medical device. Manufacturer: Phasor Health, LLC. Cleared Jun 2025. https://www.510kdatabase.net/k243382/ 2025-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k243382-rz-resectoscope-system-fda-510k.jpg K243382 - RZ Resectoscope System K243382 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Rz Medizintechnik GmbH. Cleared Jun 2025. https://www.510kdatabase.net/k243796/ 2025-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k243796-gloveone-powder-free-nitrile-fda-510k.jpg K243796 - GLOVEONE™ Powder-Free Nitrile Examination Gloves – Non-sterile [Tested for use with Chemotherapy Drugs and Fentanyl] K243796 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Glove One, LLC. Cleared Jun 2025. https://www.510kdatabase.net/k243948/ 2025-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k243948-raptor-aspiration-catheter-fda-510k.jpg K243948 - Raptor Aspiration Catheter K243948 is a FDA 510(k) cleared neurology medical device. Manufacturer: Balt USA, LLC. Cleared Jun 2025. https://www.510kdatabase.net/k250001/ 2025-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k250001-patriot-si-implant-system-fda-510k.jpg K250001 - Patriot SI Implant System K250001 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinal Simplicity, LLC. Cleared Jun 2025. https://www.510kdatabase.net/k250529/ 2025-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k250529-globe-introducer-601-01001-fda-510k.jpg K250529 - Globe Introducer (601-01001) K250529 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Kardium, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k250598/ 2025-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k250598-endoform-reconstructive-template-plga-fda-510k.jpg K250598 - Endoform Reconstructive Template - PLGA K250598 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aroa Biosurgery , Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k250657/ 2025-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k250657-gi2000-electrosurgical-generator-fda-510k.jpg K250657 - gi2000 Electrosurgical Generator K250657 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cintron Medical Corporation. Cleared Jun 2025. https://www.510kdatabase.net/k250682/ 2025-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k250682-bd-nexiva-diffusics-closed-iv-catheter-fda-510k.jpg K250682 - BD Nexiva™ Diffusics™ Closed IV Catheter System and BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector K250682 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton Dickinson Infusion Therapy Systems, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k251035/ 2025-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k251035-disintek-pa-test-strips-fda-510k.jpg K251035 - DISINTEK™ PA Test Strips K251035 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Serim Research. Cleared Jun 2025. https://www.510kdatabase.net/k251127/ 2025-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k251127-pentax-medical-video-processor-epk-fda-510k.jpg K251127 - PENTAX Medical Video Processor (EPK-i8020c) K251127 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Pentax of America, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k250410/ 2025-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k250410-gore-tri-lobe-balloon-catheter-fda-510k.jpg K250410 - GORE® Tri-Lobe Balloon Catheter K250410 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k250452/ 2025-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k250452-coralwell-single-use-ureteral-access-fda-510k.jpg K250452 - CoralWell™ Single-use Ureteral Access Sheath (NS-0835B, NS-0840B, NS-0845B, NS-0855B, NS-0935B, NS-0940B, NS-0945B, NS-0955B, NS-1035B, NS-1040B, NS-1045B, NS-1055B, NS-1135B, NS-1140B, NS-1145B, NS-1155B, NS-1235B, NS-1240B, NS-1245B, NS-1255B, NS-1335B, NS-1340B, NS-1345B, NS-1355B, NS-1435B, NS-1440B, NS-1445B, NS-1455B) K250452 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: MacroLux Medical Technology Co., Ltd.. Cleared Jun 2025. https://www.510kdatabase.net/k250844/ 2025-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k250844-pullup-fda-510k.jpg K250844 - PULLUP® K250844 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Science & Bio Materials (S.B.M.) Sas. Cleared Jun 2025. https://www.510kdatabase.net/k250965/ 2025-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k250965-automated-blood-coagulation-analyzer-fda-510k.jpg K250965 - Automated Blood Coagulation Analyzer CN-Series (CN-6000) K250965 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sysmex America, Inc.. Cleared Jun 2025. https://www.510kdatabase.net/k251335/ 2025-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k251335-tera-lumbar-interbody-fusion-system-fda-510k.jpg K251335 - Tera Lumbar Interbody Fusion System (Various PNs) K251335 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Acuity Surgical Devices, LLC. Cleared Jun 2025. https://www.510kdatabase.net/k251376/ 2025-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k251376-limflow-arc-fda-510k.jpg K251376 - LimFlow ARC K251376 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: LimFlow, Inc.. Cleared May 2025. https://www.510kdatabase.net/k241313/ 2025-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k241313-ohc-covid-19-antigen-self-test-fda-510k.jpg K241313 - OHC COVID-19 Antigen Self Test K241313 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Osang, LLC. Cleared May 2025. https://www.510kdatabase.net/k242635/ 2025-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k242635-endoscopic-distal-attachment-af-d-series-fda-510k.jpg K242635 - Endoscopic Distal Attachment (AF-D series) K242635 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Alton (Shanghai) Medical Instruments Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k242640/ 2025-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k242640-ferticult-flushing-medium-fda-510k.jpg K242640 - FertiCult Flushing medium K242640 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Fertipro NV. Cleared May 2025. https://www.510kdatabase.net/k242725/ 2025-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k242725-youha-electric-breast-pumps-the-ins-fda-510k.jpg K242725 - Youha electric breast pumps (The INs, The INs Gen2, The INs NEXT, and P3) and BEBEBAO electric breast pump (P1s) K242725 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ningbo Youhe Electrical Appliance Technology Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k242751/ 2025-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k242751-arix-pectus-bar-system-fda-510k.jpg K242751 - ARIX Pectus Bar System K242751 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Jeil Medical Corporation. Cleared May 2025. https://www.510kdatabase.net/k242830/ 2025-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k242830-lenshooke-x3-pro-semen-quality-analyzer-fda-510k.jpg K242830 - LensHooke X3 PRO Semen Quality Analyzer K242830 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bonraybio Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k242926/ 2025-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k242926-xbody-go-usa-xbody-pro-usa-fda-510k.jpg K242926 - XBody Go USA, XBody Pro USA K242926 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Xbody Hungary Kft.. Cleared May 2025. https://www.510kdatabase.net/k243005/ 2025-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k243005-audaxceph-cephalogram-analysis-software-fda-510k.jpg K243005 - AudaxCeph Cephalogram Analysis Software K243005 is a FDA 510(k) cleared radiology medical device. Manufacturer: Audax D.O.O.. Cleared May 2025. https://www.510kdatabase.net/k243010/ 2025-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k243010-fluidshield-3-fog-free-surgical-mask-fda-510k.jpg K243010 - Fluidshield * 3 Fog-Free Surgical Mask with Wraparound Anti-Glare Visor (28804) K243010 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Owens & Minor (O&M) Halyard, Inc.. Cleared May 2025. https://www.510kdatabase.net/k243505/ 2025-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k243505-5008x-hemodialysis-system-fda-510k.jpg K243505 - 5008X Hemodialysis System K243505 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC. Cleared May 2025. https://www.510kdatabase.net/k243522/ 2025-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k243522-vivi-toga-premium-fda-510k.jpg K243522 - ViVi® Toga Premium K243522 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Thi Total Healthcare Innovation GmbH. Cleared May 2025. https://www.510kdatabase.net/k243530/ 2025-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k243530-dynamic-tibase-fda-510k.jpg K243530 - Dynamic TiBase K243530 is a FDA 510(k) cleared dental medical device. Manufacturer: Talladium Espa?a, SL. Cleared May 2025. https://www.510kdatabase.net/k243654/ 2025-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k243654-dentalject-fda-510k.jpg K243654 - DentalJect K243654 is a FDA 510(k) cleared dental medical device. Manufacturer: Vapocoolshot, Inc.. Cleared May 2025. https://www.510kdatabase.net/k243863/ 2025-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k243863-opulus-lymphoma-precision-fda-510k.jpg K243863 - Opulus™ Lymphoma Precision K243863 is a FDA 510(k) cleared radiology medical device. Manufacturer: Roche Molecular Systems, Inc.. Cleared May 2025. https://www.510kdatabase.net/k250024/ 2025-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k250024-te-air-diagnostic-ultrasound-system-fda-510k.jpg K250024 - TE Air Diagnostic Ultrasound System K250024 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k250078/ 2025-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k250078-informed-vital-core-application-ivc-fda-510k.jpg K250078 - Informed Vital Core Application (IVC App) (v2.0.0.2.0.0) K250078 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Mindset Medical, Inc.. Cleared May 2025. https://www.510kdatabase.net/k250150/ 2025-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k250150-vanguard-blood-cardioplegia-systems-fda-510k.jpg K250150 - VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set) K250150 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sorin Group Italia S.R.L.. Cleared May 2025. https://www.510kdatabase.net/k250195/ 2025-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k250195-matelaser-medical-laser-therapy-fda-510k.jpg K250195 - MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60) K250195 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Matelaser, Inc.. Cleared May 2025. https://www.510kdatabase.net/k250236/ 2025-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k250236-swoop-portable-mr-imaging-system-v2-fda-510k.jpg K250236 - Swoop® Portable MR Imaging® System (V2) K250236 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hyperfine, Inc.. Cleared May 2025. https://www.510kdatabase.net/k250317/ 2025-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k250317-esflow-plus-fda-510k.jpg K250317 - EsFlow PLUS K250317 is a FDA 510(k) cleared dental medical device. Manufacturer: Spident Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k250365/ 2025-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k250365-motif-aura-glow-breast-pump-model-fda-510k.jpg K250365 - Motif Aura Glow breast pump (Model Motif Aura Glow) K250365 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shenzhen TPH Technology Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k250368/ 2025-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k250368-wearable-breast-pump-model-s21-fda-510k.jpg K250368 - Wearable Breast Pump (Model S21) K250368 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shenzhen TPH Technology Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k250581/ 2025-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k250581-kala-red-light-face-mask-kala-01-fda-510k.jpg K250581 - KALA Red Light Face Mask (KALA-01) K250581 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Kaiyan Medical Equipment Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k250637/ 2025-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k250637-vcfix-spinal-system-fda-510k.jpg K250637 - VCFix Spinal System K250637 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Amber Implants. Cleared May 2025. https://www.510kdatabase.net/k250957/ 2025-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k250957-disposable-biopsy-forceps-fb-211d-fda-510k.jpg K250957 - Disposable Biopsy Forceps (FB-211D) K250957 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Olympus Medical Systems Corporation. Cleared May 2025. https://www.510kdatabase.net/k251063/ 2025-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k251063-tekbrace-solo-soft-tissue-fda-510k.jpg K251063 - TekBrace Solo Soft Tissue Reinforcement Device K251063 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Theramicro. Cleared May 2025. https://www.510kdatabase.net/k251238/ 2025-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k251238-vasoview-hemopro-3-endoscopic-vessel-fda-510k.jpg K251238 - Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000) K251238 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Maquet Cardiovascular, LLC. Cleared May 2025. https://www.510kdatabase.net/k251383/ 2025-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k251383-prestige-coil-system-prestige-packing-fda-510k.jpg K251383 - Prestige Coil System (Prestige Packing Line Extension) K251383 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Balt USA, LLC. Cleared May 2025. https://www.510kdatabase.net/k251406/ 2025-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k251406-briefcase-triage-fda-510k.jpg K251406 - BriefCase-Triage K251406 is a FDA 510(k) cleared radiology medical device. Manufacturer: Aidoc Medical , Ltd.. Cleared May 2025. https://www.510kdatabase.net/den240047/ 2025-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/den240047-allix5-fda-510k.jpg DEN240047 - Allix5 DEN240047 is a FDA 510(k) cleared radiology medical device. Manufacturer: Clairity, Inc.. Cleared May 2025. https://www.510kdatabase.net/k243309/ 2025-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k243309-27g-x-12-tw-k-pack-surshield-needle-kn-fda-510k.jpg K243309 - 27G x 1/2 TW K-Pack Surshield Needle (KN-S2713RBT) K243309 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terumo Europe N.V.. Cleared May 2025. https://www.510kdatabase.net/k243372/ 2025-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k243372-biliwrap-fda-510k.jpg K243372 - BiliWrap K243372 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Gerium Medical, Ltd.. Cleared May 2025. https://www.510kdatabase.net/k243469/ 2025-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k243469-signex-fda-510k.jpg K243469 - SIGNEX K243469 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonic Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k243480/ 2025-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k243480-suturepatch-tissue-reinforcement-fda-510k.jpg K243480 - SuturePatch Tissue Reinforcement K243480 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared May 2025. https://www.510kdatabase.net/k243484/ 2025-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k243484-pm2-system-and-smartpicc-stylet-fda-510k.jpg K243484 - PM2+ System and SmartPICC Stylet K243484 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Piccolo Medical, Inc.. Cleared May 2025. https://www.510kdatabase.net/k243497/ 2025-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k243497-portable-video-processor-ea101-fda-510k.jpg K243497 - Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US, BS46H-17EU, BS50H-20EU, BS46H-17US, BS50H-20US, BS53H-22EU, BS53H-22US, BS55H-24EU, BS55H-24US, BS59H-28EU, BS59H-28US K243497 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Shanghai AnQing Medical Instrument Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k243856/ 2025-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k243856-tens-and-ems-tens-and-muscle-fda-510k.jpg K243856 - TENS AND EMS (TENS and Muscle Stimulator) ( Model AS8012C,AS8016,AS8019,AS9020E,AS9026) K243856 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Astec Technology Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k250048/ 2025-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k250048-neuromark-system-nmk00301-fda-510k.jpg K250048 - NEUROMARK System (NMK00301) K250048 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Neurent Medical , Ltd.. Cleared May 2025. https://www.510kdatabase.net/k250215/ 2025-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k250215-baha-7-sound-processor-fda-510k.jpg K250215 - Baha 7 Sound Processor K250215 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Cochlear. Cleared May 2025. https://www.510kdatabase.net/k250307/ 2025-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k250307-visualase-v2-mri-guided-laser-ablation-fda-510k.jpg K250307 - Visualase V2 MRI-guided Laser Ablation System (9736422) K250307 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Navigation. Cleared May 2025. https://www.510kdatabase.net/k250543/ 2025-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k250543-voluson-performance-16-fda-510k.jpg K250543 - Voluson™ Performance 16 K250543 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared May 2025. https://www.510kdatabase.net/k250606/ 2025-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k250606-dental-barrier-and-sleeves-fda-510k.jpg K250606 - Dental Barrier and Sleeves K250606 is a FDA 510(k) cleared dental medical device. Manufacturer: Yueying Medical Instruments (Langfang) Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k250673/ 2025-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k250673-cerabien-milai-fda-510k.jpg K250673 - CERABIEN MiLai K250673 is a FDA 510(k) cleared dental medical device. Manufacturer: Kuraray Noritake Dental, Inc.. Cleared May 2025. https://www.510kdatabase.net/k250757/ 2025-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k250757-radius-vsm-and-accessories-fda-510k.jpg K250757 - Radius VSM and Accessories K250757 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Masimo Corporation. Cleared May 2025. https://www.510kdatabase.net/k251315/ 2025-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k251315-anatase-spine-surgery-navigation-fda-510k.jpg K251315 - Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation System II K251315 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Remex Medical Corp.. Cleared May 2025. https://www.510kdatabase.net/k251325/ 2025-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k251325-versacross-connect-transseptal-dilator-fda-510k.jpg K251325 - VersaCross Connect™ Transseptal Dilator K251325 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baylis Medical Company, Inc.. Cleared May 2025. https://www.510kdatabase.net/k251340/ 2025-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k251340-proseal-bag-spike-with-additive-port-fda-510k.jpg K251340 - ProSeal™ Bag Spike with Additive Port (423370ST, 423370) K251340 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Epic Medical Pte. , Ltd.. Cleared May 2025. https://www.510kdatabase.net/den240048/ 2025-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/den240048-spur-peripheral-retrievable-stent-system-fda-510k.jpg DEN240048 - Spur Peripheral Retrievable Stent System DEN240048 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Reflow Medical, Inc.. Cleared May 2025. https://www.510kdatabase.net/k240950/ 2025-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k240950-disposable-prophy-angle-fda-510k.jpg K240950 - Disposable Prophy Angle K240950 is a FDA 510(k) cleared dental medical device. Manufacturer: Pacific Care Limited. Cleared May 2025. https://www.510kdatabase.net/k242699/ 2025-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k242699-flexible-ureteroscope-u-scope2812-fda-510k.jpg K242699 - Flexible Ureteroscope (U-Scope)(2.8/1.2) (OMI161-2F28-CH12-US) K242699 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Opcom Medical, Inc.. Cleared May 2025. https://www.510kdatabase.net/k242752/ 2025-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k242752-mridium-3870-mri-infusion-pump-system-fda-510k.jpg K242752 - MRidium 3870 MRI Infusion Pump System (3870) K242752 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Iradimed Corporation. Cleared May 2025. https://www.510kdatabase.net/k242793/ 2025-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k242793-insighters-single-use-fda-510k.jpg K242793 - Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0 K242793 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Shenzhen Insighters Medical Technology Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k243047/ 2025-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k243047-zoom-7x-catheter-fda-510k.jpg K243047 - Zoom 7X Catheter K243047 is a FDA 510(k) cleared neurology medical device. Manufacturer: Imperative Care, Inc.. Cleared May 2025. https://www.510kdatabase.net/k243378/ 2025-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k243378-rapid-mls-fda-510k.jpg K243378 - Rapid MLS K243378 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ischemaview, Inc.. Cleared May 2025. https://www.510kdatabase.net/k243716/ 2025-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k243716-zionic-pro-max-radiofrequency-fda-510k.jpg K243716 - Zionic Pro Max (Radiofrequency) K243716 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Termosalud S.L.. Cleared May 2025. https://www.510kdatabase.net/k243949/ 2025-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k243949-osteoflo-hydrofiber-fda-510k.jpg K243949 - OsteoFlo HydroFiber K243949 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SurGenTec, LLC. Cleared May 2025. https://www.510kdatabase.net/k244049/ 2025-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k244049-europa-alternative-airtouch-portable-x-fda-510k.jpg K244049 - Europa (Alternative: AiRTouch) portable X-ray system K244049 is a FDA 510(k) cleared radiology medical device. Manufacturer: Livermoretech, Inc.. Cleared May 2025. https://www.510kdatabase.net/k250367/ 2025-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k250367-columbox-fda-510k.jpg K250367 - CoLumboX K250367 is a FDA 510(k) cleared radiology medical device. Manufacturer: Smart Soft Healthcare AD. Cleared May 2025. https://www.510kdatabase.net/k250427/ 2025-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k250427-taimedimg-deepmets-fda-510k.jpg K250427 - TAIMedImg DeepMets K250427 is a FDA 510(k) cleared radiology medical device. Manufacturer: Taiwan Medical Imaging Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k250624/ 2025-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k250624-myair-fda-510k.jpg K250624 - myAir K250624 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: ResMed Corp. Cleared May 2025. https://www.510kdatabase.net/k251344/ 2025-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k251344-optimap-system-fda-510k.jpg K251344 - OptiMap™ System K251344 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared May 2025. https://www.510kdatabase.net/k242604/ 2025-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k242604-helios-uv-c-system-fda-510k.jpg K242604 - Helios+ UV-C System K242604 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Preventamed Technologies, Inc. Dba Surfacide Manufacturing. Cleared May 2025. https://www.510kdatabase.net/k242611/ 2025-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k242611-integral-dental-units-fda-510k.jpg K242611 - Integral Dental Units K242611 is a FDA 510(k) cleared dental medical device. Manufacturer: Mipont Medical Equipment Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k242820/ 2025-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k242820-puritan-pursafe-plus-collection-and-fda-510k.jpg K242820 - Puritan PurSafe Plus Collection and Transport System K242820 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Puritan Medical Products, LLC. Cleared May 2025. https://www.510kdatabase.net/k242841/ 2025-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k242841-disposable-rf-electrode-rfde-5rfde-fda-510k.jpg K242841 - Disposable RF Electrode (RFDE-5/RFDE-10/RFDE-15/RFDE-20) K242841 is a FDA 510(k) cleared neurology medical device. Manufacturer: Abbott Medical. Cleared May 2025. https://www.510kdatabase.net/k243777/ 2025-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k243777-rennou-varnish-3-spearmint-fda-510k.jpg K243777 - Rennou™ Varnish (3% / Spearmint) K243777 is a FDA 510(k) cleared dental medical device. Manufacturer: Theodent, LLC. Cleared May 2025. https://www.510kdatabase.net/k250435/ 2025-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k250435-dexter-l6-system-fda-510k.jpg K250435 - Dexter L6 System K250435 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Distalmotion SA. Cleared May 2025. https://www.510kdatabase.net/k250475/ 2025-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k250475-electric-wheelchair-bc-ea5516-bc-fda-510k.jpg K250475 - Electric Wheelchair (BC-EA5516, BC-EC8002, BC-EC8003, BC-EALD3) K250475 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Ningbo Baichen Medical Devices Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k250573/ 2025-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k250573-single-use-cannula-v-pr-fda-510k.jpg K250573 - Single Use Cannula V PR-V223Q/V414Q/V416Q/V418Q/V420Q/V427Q/V434Q/V435Q K250573 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared May 2025. https://www.510kdatabase.net/k250614/ 2025-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k250614-neodent-implant-system-custom-abutments-fda-510k.jpg K250614 - Neodent Implant System - Custom Abutments K250614 is a FDA 510(k) cleared dental medical device. Manufacturer: Jjgc Ind?stria E Com?rcia DE Materiais Dent?rios S.A.. Cleared May 2025. https://www.510kdatabase.net/k250932/ 2025-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k250932-deeprhythmai-fda-510k.jpg K250932 - DeepRhythmAI K250932 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medicalgorithmics S.A.. Cleared May 2025. https://www.510kdatabase.net/k251309/ 2025-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k251309-ossiofiber-suture-anchor-fda-510k.jpg K251309 - OSSIOfiber® Suture Anchor K251309 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OSSIO , Ltd.. Cleared May 2025. https://www.510kdatabase.net/k251578/ 2025-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k251578-beautifil-ii-fda-510k.jpg K251578 - BEAUTIFIL II K251578 is a FDA 510(k) cleared dental medical device. Manufacturer: Shofu Dental Corporation. Cleared May 2025. https://www.510kdatabase.net/k242545/ 2025-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k242545-radiforce-mx317w-pa-fda-510k.jpg K242545 - RadiForce MX317W-PA K242545 is a FDA 510(k) cleared pathology medical device. Manufacturer: Eizo Corporation. Cleared May 2025. https://www.510kdatabase.net/k242575/ 2025-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k242575-stereotaxic-guiding-surgical-devices-fda-510k.jpg K242575 - Stereotaxic Guiding Surgical Devices, NaoTrac S K242575 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brain Navi Biotechnology Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k242594/ 2025-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k242594-deepecho-fda-510k.jpg K242594 - DEEPECHO K242594 is a FDA 510(k) cleared radiology medical device. Manufacturer: Deepecho. Cleared May 2025. https://www.510kdatabase.net/k243023/ 2025-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k243023-wizard-520-full-face-mask-fda-510k.jpg K243023 - WiZARD 520 Full Face Mask K243023 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Wellell, Inc.. Cleared May 2025. https://www.510kdatabase.net/k243261/ 2025-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k243261-fujifilm-endoscope-model-ec-860pm-fda-510k.jpg K243261 - FUJIFILM Endoscope Model EC-860P/M K243261 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fujifilm Corporation. Cleared May 2025. https://www.510kdatabase.net/k243474/ 2025-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k243474-magnetos-mis-fda-510k.jpg K243474 - MagnetOs MIS K243474 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Kuros Biosciences B.V. Cleared May 2025. https://www.510kdatabase.net/k243937/ 2025-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k243937-accuro-3s-fda-510k.jpg K243937 - Accuro 3S K243937 is a FDA 510(k) cleared radiology medical device. Manufacturer: Rivanna Medical, Inc.. Cleared May 2025. https://www.510kdatabase.net/k243989/ 2025-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k243989-second-opinion-3d-fda-510k.jpg K243989 - Second Opinion® 3D K243989 is a FDA 510(k) cleared radiology medical device. Manufacturer: Pearl, Inc.. Cleared May 2025. https://www.510kdatabase.net/k244047/ 2025-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k244047-navi-needle-free-blood-collection-fda-510k.jpg K244047 - Navi™ Needle-free Blood Collection Device (VNC20500FG, VNC22500FG, VNC24500FG) K244047 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Venocare, Inc.. Cleared May 2025. https://www.510kdatabase.net/k250005/ 2025-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k250005-clever-one-fda-510k.jpg K250005 - Clever One K250005 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ewoosoft Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k250239/ 2025-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k250239-neuromatch-fda-510k.jpg K250239 - NeuroMatch K250239 is a FDA 510(k) cleared neurology medical device. Manufacturer: LVIS Corporation. Cleared May 2025. https://www.510kdatabase.net/k250361/ 2025-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k250361-smartappguidedtm-microcurrent-face-fda-510k.jpg K250361 - SmartAppGuidedTM MicroCurrent Face-Lift Pen 6 in 1 K250361 is a FDA 510(k) cleared neurology medical device. Manufacturer: Geske Beauty Tech GmbH. Cleared May 2025. https://www.510kdatabase.net/k250384/ 2025-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k250384-ipl400-fda-510k.jpg K250384 - IPL400 K250384 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: El Global Trade, Ltd.. Cleared May 2025. https://www.510kdatabase.net/k250446/ 2025-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k250446-frida-anterior-cervical-plate-system-fda-510k.jpg K250446 - Frida™ Anterior Cervical Plate System K250446 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spineup, Inc.. Cleared May 2025. https://www.510kdatabase.net/k250544/ 2025-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k250544-knotilus-biocomposite-knotless-anchor-fda-510k.jpg K250544 - Knotilus+ Biocomposite Knotless Anchor K250544 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Endoscopy. Cleared May 2025. https://www.510kdatabase.net/k250549/ 2025-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k250549-optilite-freelite-mx-kappa-free-kit-fda-510k.jpg K250549 - Optilite® Freelite Mx Kappa Free Kit K250549 is a FDA 510(k) cleared immunology medical device. Manufacturer: The Binding Site Group , Ltd.. Cleared May 2025. https://www.510kdatabase.net/k250778/ 2025-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k250778-sil-flow-fda-510k.jpg K250778 - Sil-Flow K250778 is a FDA 510(k) cleared dental medical device. Manufacturer: Dsi Dental Solutions, Ltd.. Cleared May 2025. https://www.510kdatabase.net/k250938/ 2025-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k250938-ice-cooling-ipl-hair-removal-device-fda-510k.jpg K250938 - Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01 WG, MI01 WH, MI01 BK K250938 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Ulike Smart Electronics Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k251044/ 2025-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k251044-93-neuflex-catheter-fda-510k.jpg K251044 - 93 NeuFlex Catheter K251044 is a FDA 510(k) cleared neurology medical device. Manufacturer: Piraeus Medical. Cleared May 2025. https://www.510kdatabase.net/k251211/ 2025-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k251211-viewflex-xtra-ice-catheter-fda-510k.jpg K251211 - ViewFlex™ Xtra ICE Catheter K251211 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared May 2025. https://www.510kdatabase.net/k251292/ 2025-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k251292-reclaim-monobloc-revision-femoral-stem-fda-510k.jpg K251292 - RECLAIM Monobloc Revision Femoral Stem K251292 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Ireland UC. Cleared May 2025. https://www.510kdatabase.net/k242586/ 2025-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k242586-argocap-20052-fda-510k.jpg K242586 - ArgoCap (200.52) K242586 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ovesco Endoscopy AG. Cleared May 2025. https://www.510kdatabase.net/k242659/ 2025-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k242659-the-sensititre-18-24-hour-mic-or-fda-510k.jpg K242659 - The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Vancomycin in the dilution range of 0.25-128 ug/mL K242659 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Thermo Fisher Scientific. Cleared May 2025. https://www.510kdatabase.net/k242684/ 2025-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k242684-harioculture-tl-16-time-lapse-incubator-fda-510k.jpg K242684 - Harioculture TL-16 Time-lapse Incubator K242684 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Hua Yue Medical Technology Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k250532/ 2025-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k250532-solawave-2-in-1-skincare-mini-model-fda-510k.jpg K250532 - Solawave 2-in-1 Skincare Mini (Model: 61043) K250532 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Kaiyan Medical Equipment Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k250630/ 2025-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k250630-nitrile-powder-free-exam-gloves-with-fda-510k.jpg K250630 - Nitrile Powder-Free Exam Gloves with Hyaluronic Acid, and tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Xylazine in Fentanyl Citrate K250630 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Basic Medical Technology, Inc.. Cleared May 2025. https://www.510kdatabase.net/k250639/ 2025-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k250639-dess-dental-smart-solutions-fda-510k.jpg K250639 - DESS Dental Smart Solutions K250639 is a FDA 510(k) cleared dental medical device. Manufacturer: Terrats Medical SL. Cleared May 2025. https://www.510kdatabase.net/k250878/ 2025-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k250878-yuwell-infrared-ear-thermometer-yht100-fda-510k.jpg K250878 - YUWELL® Infrared Ear Thermometer (YHT100) K250878 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Yuyue Medical Equipment& Supply Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k250897/ 2025-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k250897-koala-intrauterine-pressure-catheter-fda-510k.jpg K250897 - Koala Intrauterine Pressure Catheter (IPC-5000E) K250897 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Clinical Innovations, LLC. Cleared May 2025. https://www.510kdatabase.net/k250910/ 2025-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k250910-optilume-high-pressure-urological-fda-510k.jpg K250910 - Optilume® High Pressure Urological Balloon Dilation Catheter K250910 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Urotronic, Inc.. Cleared May 2025. https://www.510kdatabase.net/k250920/ 2025-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k250920-arthrex-spine-compression-ft-screw-fda-510k.jpg K250920 - Arthrex Spine Compression FT Screw K250920 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared May 2025. https://www.510kdatabase.net/k250935/ 2025-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k250935-trimed-fifth-metatarsal-system-fifth-fda-510k.jpg K250935 - TriMed Fifth Metatarsal System (Fifth Metatarsal Plate) K250935 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: TriMed, Inc.. Cleared May 2025. https://www.510kdatabase.net/k250980/ 2025-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k250980-physica-system-physica-cr-porous-fda-510k.jpg K250980 - Physica System (Physica CR Porous Femoral components) K250980 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Lima Corporate S.P.A.. Cleared May 2025. https://www.510kdatabase.net/k251052/ 2025-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k251052-trivicta-hip-stem-fda-510k.jpg K251052 - Trivicta® Hip Stem K251052 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ortho Development Corp.. Cleared May 2025. https://www.510kdatabase.net/k251493/ 2025-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k251493-skin-clinic-freeze-point-for-warts-and-fda-510k.jpg K251493 - Skin Clinic Freeze Point for Warts and Skin Tags K251493 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cryoconcepts LP. Cleared May 2025. https://www.510kdatabase.net/den240035/ 2025-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/den240035-concizutrace-elisa-fda-510k.jpg DEN240035 - ConcizuTrace™ ELISA DEN240035 is a FDA 510(k) cleared hematology medical device. Manufacturer: Randox Laboratories, Ltd.. Cleared May 2025. https://www.510kdatabase.net/k242527/ 2025-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k242527-the-karma-fixation-system-fda-510k.jpg K242527 - The Karma® Fixation System K242527 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinal Elements, Inc.. Cleared May 2025. https://www.510kdatabase.net/k242637/ 2025-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k242637-mem-clear-aligner-system-fda-510k.jpg K242637 - MEM Clear Aligner System K242637 is a FDA 510(k) cleared dental medical device. Manufacturer: Mem Dental Technology Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k242857/ 2025-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k242857-clearhemograsper-fda-510k.jpg K242857 - ClearHemograsper K242857 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Finemedix Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k243116/ 2025-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k243116-flarehawk-interbody-fusion-system-fda-510k.jpg K243116 - FlareHawk Interbody Fusion System K243116 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Integrity Implants Inc. Dba Accelus. Cleared May 2025. https://www.510kdatabase.net/k243122/ 2025-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k243122-umr-omega-fda-510k.jpg K243122 - uMR Omega K243122 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k243302/ 2025-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k243302-3dmatrix-dynaflex-dynaflex-fda-510k.jpg K243302 - 3DMatrix DynaFlex (DynaFlex) K243302 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Printbio, Inc.. Cleared May 2025. https://www.510kdatabase.net/k243429/ 2025-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k243429-hjy-visualnext-3d-endoscopic-vision-fda-510k.jpg K243429 - HJY VisualNext 3D Endoscopic Vision System K243429 is a FDA 510(k) cleared neurology medical device. Manufacturer: Hjy Smart Medical Device Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k243762/ 2025-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k243762-synapse-3d-base-tools-v70-fda-510k.jpg K243762 - Synapse 3D Base Tools (V7.0) K243762 is a FDA 510(k) cleared radiology medical device. Manufacturer: Fujifilm Corporation. Cleared May 2025. https://www.510kdatabase.net/k243793/ 2025-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k243793-epiq-series-diagnostic-ultrasound-system-fda-510k.jpg K243793 - EPIQ Series Diagnostic Ultrasound System K243793 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Ultrasound, LLC. Cleared May 2025. https://www.510kdatabase.net/k243866/ 2025-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k243866-invision-precision-cardiac-amyloid-fda-510k.jpg K243866 - InVision Precision Cardiac Amyloid K243866 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Invision Medical Technology Corporation. Cleared May 2025. https://www.510kdatabase.net/k250493/ 2025-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k250493-motilicap-gi-monitoring-system-fda-510k.jpg K250493 - MotiliCap GI Monitoring System K250493 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Anx Robotica Corporation. Cleared May 2025. https://www.510kdatabase.net/k250528/ 2025-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k250528-stryker-alphavent-knotless-sp-fda-510k.jpg K250528 - Stryker AlphaVent™ Knotless SP Biocomposite Anchor K250528 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Endoscopy. Cleared May 2025. https://www.510kdatabase.net/k250798/ 2025-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k250798-control-iq-technology-fda-510k.jpg K250798 - Control-IQ+ technology K250798 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Tandem Diabetes Care, Inc.. Cleared May 2025. https://www.510kdatabase.net/k251109/ 2025-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k251109-smartdent-fda-510k.jpg K251109 - SMARTDent K251109 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ray Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k251230/ 2025-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k251230-the-alma-hybrid-laser-system-fda-510k.jpg K251230 - The Alma Hybrid Laser System K251230 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Alma Lasers, Inc.. Cleared May 2025. https://www.510kdatabase.net/k251239/ 2025-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k251239-grandioso-unlimited-fda-510k.jpg K251239 - GrandioSO Unlimited K251239 is a FDA 510(k) cleared dental medical device. Manufacturer: Voco GmbH. Cleared May 2025. https://www.510kdatabase.net/k251276/ 2025-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k251276-swoop-portable-mr-imaging-system-fda-510k.jpg K251276 - Swoop® Portable MR Imaging® System K251276 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hyperfine, Inc.. Cleared May 2025. https://www.510kdatabase.net/k242485/ 2025-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k242485-everyware-fda-510k.jpg K242485 - EveryWare K242485 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Breas Medical AB. Cleared May 2025. https://www.510kdatabase.net/k250199/ 2025-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k250199-vitalflow-console-fda-510k.jpg K250199 - VitalFlow Console K250199 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared May 2025. https://www.510kdatabase.net/k250243/ 2025-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k250243-provu-single-use-video-stylet-with-fda-510k.jpg K250243 - ProVu Single Use Video Stylet with Reinforced ET Tube (Size 6.5) (038-995-065U) K250243 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Flexicare Medical Limited.. Cleared May 2025. https://www.510kdatabase.net/k250370/ 2025-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k250370-scenaria-view-phase-50-fda-510k.jpg K250370 - SCENARIA View Phase 5.0 K250370 is a FDA 510(k) cleared radiology medical device. Manufacturer: Fujifilm Corporation. Cleared May 2025. https://www.510kdatabase.net/k250489/ 2025-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k250489-fp3d-fda-510k.jpg K250489 - FP3D K250489 is a FDA 510(k) cleared dental medical device. Manufacturer: Keystone Industries. Cleared May 2025. https://www.510kdatabase.net/k250534/ 2025-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k250534-biomic-color-opaque-fda-510k.jpg K250534 - Biomic Color Opaque K250534 is a FDA 510(k) cleared dental medical device. Manufacturer: Aidite (Qinhuangdao) Technology Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k250602/ 2025-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k250602-x-pac-n-gage-lumbar-plate-system-fda-510k.jpg K250602 - X-PAC® N-GAGE™ Lumbar Plate System K250602 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Expanding Innovations, Inc.. Cleared May 2025. https://www.510kdatabase.net/k250866/ 2025-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k250866-sovereign-posterior-cervical-system-fda-510k.jpg K250866 - Sovereign Posterior Cervical System K250866 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Met One Technologies, LLC. Cleared May 2025. https://www.510kdatabase.net/k251231/ 2025-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k251231-viewflex-x-ice-catheter-sensor-enabled-fda-510k.jpg K251231 - ViewFlex™ X ICE Catheter, Sensor Enabled™ K251231 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared May 2025. https://www.510kdatabase.net/k242547/ 2025-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k242547-airfit-f20-mask-system-fda-510k.jpg K242547 - AirFit F20 Mask System K242547 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Resmed Pty , Ltd.. Cleared May 2025. https://www.510kdatabase.net/k242755/ 2025-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k242755-medical-diode-laser-systems-velas-ii-fda-510k.jpg K242755 - Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B) K242755 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Gigaalaser Company , Ltd.. Cleared May 2025. https://www.510kdatabase.net/k243301/ 2025-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k243301-maprt-fda-510k.jpg K243301 - MapRT K243301 is a FDA 510(k) cleared radiology medical device. Manufacturer: Vision Rt, Ltd.. Cleared May 2025. https://www.510kdatabase.net/k243411/ 2025-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k243411-diagnostic-x-ray-system-fda-510k.jpg K243411 - Diagnostic X-ray System K243411 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nanjing Perlove Medical Equipment Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k243601/ 2025-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k243601-route-92-medical-hipoint-reperfusion-fda-510k.jpg K243601 - Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set K243601 is a FDA 510(k) cleared neurology medical device. Manufacturer: Route 92 Medical, Inc.. Cleared May 2025. https://www.510kdatabase.net/k243643/ 2025-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k243643-restor3d-reverse-total-shoulder-fda-510k.jpg K243643 - restor3d Reverse Total Shoulder Arthroplasty System K243643 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Restor3d. Cleared May 2025. https://www.510kdatabase.net/k250020/ 2025-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k250020-diagnostic-ultrasound-system-recho-r9w-fda-510k.jpg K250020 - Diagnostic Ultrasound System (Recho R9W) K250020 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k250038/ 2025-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k250038-muscle-stimulator-device-pz-100-fda-510k.jpg K250038 - Muscle Stimulator Device (PZ-100) K250038 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zhengzhou PZ Laser Slim Technology Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k250122/ 2025-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k250122-sleepright-snore-aid-fda-510k.jpg K250122 - SleepRight Snore Aid K250122 is a FDA 510(k) cleared dental medical device. Manufacturer: Splintek, Inc.. Cleared May 2025. https://www.510kdatabase.net/k250390/ 2025-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k250390-closys-dry-mouth-sensitive-mouth-rinse-fda-510k.jpg K250390 - CloSYS® Dry Mouth Sensitive Mouth Rinse K250390 is a FDA 510(k) cleared dental medical device. Manufacturer: Rowpar Pharmaceuticals, Inc.. Cleared May 2025. https://www.510kdatabase.net/k250447/ 2025-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k250447-bd-phoenix-automated-microbiology-fda-510k.jpg K250447 - BD Phoenix™ Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL) K250447 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson and Company. Cleared May 2025. https://www.510kdatabase.net/k250456/ 2025-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k250456-dentemp-pro-comfort-dental-guard-fda-510k.jpg K250456 - Dentemp Pro-Comfort Dental Guard K250456 is a FDA 510(k) cleared dental medical device. Manufacturer: Doc Brands, Inc.. Cleared May 2025. https://www.510kdatabase.net/k240554/ 2025-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k240554-inferread-lung-ctai-fda-510k.jpg K240554 - InferRead Lung CT.AI K240554 is a FDA 510(k) cleared radiology medical device. Manufacturer: Infervision Medical Technology Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k241581/ 2025-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k241581-hemodialysis-catheter-fda-510k.jpg K241581 - Hemodialysis Catheter K241581 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Haolang Medical USA Corporation. Cleared May 2025. https://www.510kdatabase.net/k241671/ 2025-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k241671-6450-ultrasound-system-mylabe80-fda-510k.jpg K241671 - 6450 Ultrasound System (MyLabE80) K241671 is a FDA 510(k) cleared radiology medical device. Manufacturer: Esaote, S.P.A.. Cleared May 2025. https://www.510kdatabase.net/k242438/ 2025-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k242438-clearo-fda-510k.jpg K242438 - Clearo K242438 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Breas Medical AB. Cleared May 2025. https://www.510kdatabase.net/k242569/ 2025-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k242569-mixed-reality-spine-navigation-fda-510k.jpg K242569 - Mixed Reality Spine Navigation K242569 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Brainlab AG. Cleared May 2025. https://www.510kdatabase.net/k242585/ 2025-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k242585-cystatin-c-fda-510k.jpg K242585 - Cystatin C K242585 is a FDA 510(k) cleared chemistry medical device. Manufacturer: SENTINEL CH. SpA. Cleared May 2025. https://www.510kdatabase.net/k242706/ 2025-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k242706-lumipulse-g-ptau217-amyloid-1-42-fda-510k.jpg K242706 - Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio K242706 is a FDA 510(k) cleared immunology medical device. Manufacturer: Fujirebio Diagnostics,Inc.. Cleared May 2025. https://www.510kdatabase.net/k242731/ 2025-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k242731-masterad-minix-mobile-digital-imaging-fda-510k.jpg K242731 - MasteRad MiniX Mobile Digital Imaging System (Mini-X) K242731 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medicatech USA, Inc.. Cleared May 2025. https://www.510kdatabase.net/k243105/ 2025-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k243105-ruby-intravascular-catheter-fda-510k.jpg K243105 - Ruby Intravascular Catheter K243105 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Venocare, Inc.. Cleared May 2025. https://www.510kdatabase.net/k243176/ 2025-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k243176-blessing-system-fda-510k.jpg K243176 - BLESSING System K243176 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cellah Medical Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k243371/ 2025-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k243371-byonyks-x-1-apd-cycler-fda-510k.jpg K243371 - Byonyks X-1 APD Cycler K243371 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Byonyks Pvt, Ltd.. Cleared May 2025. https://www.510kdatabase.net/k243602/ 2025-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k243602-arthrex-spine-endoscope-fda-510k.jpg K243602 - Arthrex Spine Endoscope K243602 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared May 2025. https://www.510kdatabase.net/k243617/ 2025-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k243617-uct-atlas-astound-with-uws-ct-dual-fda-510k.jpg K243617 - uCT ATLAS Astound with uWS-CT-Dual Energy Analysis K243617 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k243837/ 2025-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k243837-ibsm-fda-510k.jpg K243837 - iBSM K243837 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Iorbit Digital Technologies Private Limited. Cleared May 2025. https://www.510kdatabase.net/k243927/ 2025-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k243927-mobilelink-acetabular-cup-system-fda-510k.jpg K243927 - MobileLink Acetabular Cup System - inhouse coatings K243927 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Waldemar Link GmbH & Co. KG. Cleared May 2025. https://www.510kdatabase.net/k244008/ 2025-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k244008-spectral-ct-fda-510k.jpg K244008 - Spectral CT K244008 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Technologies , Ltd.. Cleared May 2025. https://www.510kdatabase.net/k244033/ 2025-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k244033-electric-nasal-aspirator-fda-510k.jpg K244033 - Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610) K244033 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Shenzhen Desida Technology Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k250086/ 2025-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k250086-ots-hip-fda-510k.jpg K250086 - OTS Hip K250086 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ortoma AB. Cleared May 2025. https://www.510kdatabase.net/k250099/ 2025-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k250099-mobius3d-41-fda-510k.jpg K250099 - Mobius3D (4.1) K250099 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems. Cleared May 2025. https://www.510kdatabase.net/k250110/ 2025-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k250110-diagnostic-ultrasound-system-mx6-fda-510k.jpg K250110 - Diagnostic Ultrasound System (MX6) K250110 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k250141/ 2025-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k250141-synthecure-synthetic-calcium-sulfate-fda-510k.jpg K250141 - Synthecure Synthetic Calcium Sulfate K250141 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Austin Medical Ventures, Inc.. Cleared May 2025. https://www.510kdatabase.net/k250971/ 2025-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k250971-embosphere-microspheres-fda-510k.jpg K250971 - Embosphere Microspheres K250971 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biosphere Medical, S.A.. Cleared May 2025. https://www.510kdatabase.net/k251184/ 2025-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k251184-altivate-reverse-shoulder-system-fda-510k.jpg K251184 - AltiVate Reverse Shoulder System K251184 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Encore Medical, L.P.. Cleared May 2025. https://www.510kdatabase.net/k240857/ 2025-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k240857-youmagic-flm-system-ym5-u1-fda-510k.jpg K240857 - Youmagic FLM System (YM5-U1) K240857 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: We Medical Technology (Wuxi) Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k242155/ 2025-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k242155-dbb-06-pro-hemodialysis-delivery-fda-510k.jpg K242155 - DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) K242155 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: NIKKISO CO., LTD.. Cleared May 2025. https://www.510kdatabase.net/k242176/ 2025-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k242176-blood-tubing-lines-for-hemodialysis-al-fda-510k.jpg K242176 - BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series (AL-ADC-E(U), AL-CDC-E(U), C18RDC-E(U), C18BDD-E(U), C18SFD-E(U) K242176 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: NIKKISO CO., LTD.. Cleared May 2025. https://www.510kdatabase.net/k242479/ 2025-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k242479-blood-tubing-lines-for-hemodialysis-al-fda-510k.jpg K242479 - BLOOD TUBING LINES FOR HEMODIALYSIS AL Series (Archloop) BLOOD TUBING LINES FOR HEMODIALYSIS C18 Series AL-ADC-PU, AL-CDC-PU, C18RDC-PU, C18BDD-PU, C18SFD-PU K242479 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: NIKKISO CO., LTD.. Cleared May 2025. https://www.510kdatabase.net/k242518/ 2025-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k242518-hypertension-prediction-index-hepi-fda-510k.jpg K242518 - Hypertension Prediction Index (HePI) Algorithm K242518 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared May 2025. https://www.510kdatabase.net/k242519/ 2025-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k242519-lumify-diagnostic-ultrasound-system-fda-510k.jpg K242519 - Lumify Diagnostic Ultrasound System K242519 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Ultrasound. Cleared May 2025. https://www.510kdatabase.net/k242931/ 2025-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k242931-hft750u-fda-510k.jpg K242931 - HFT750U K242931 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Mekics Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k243165/ 2025-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k243165-limfa-therapy-system-limfa-therapy-fda-510k.jpg K243165 - Limfa Therapy System (Limfa Therapy) K243165 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Eywa Srl. Cleared May 2025. https://www.510kdatabase.net/k250213/ 2025-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k250213-optablate-bvn-intraosseous-nerve-fda-510k.jpg K250213 - OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit) K250213 is a FDA 510(k) cleared neurology medical device. Manufacturer: Stryker Instruments. Cleared May 2025. https://www.510kdatabase.net/k250276/ 2025-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k250276-nitinol-enhanced-device-ned-fda-510k.jpg K250276 - Nitinol Enhanced Device (NED) K250276 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Embolization, Inc.. Cleared May 2025. https://www.510kdatabase.net/k250432/ 2025-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k250432-colonovideoscope-cf-ez1500dl-fda-510k.jpg K250432 - Colonovideoscope (CF-EZ1500DL) K250432 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Medical Systems Corporation. Cleared May 2025. https://www.510kdatabase.net/k250444/ 2025-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k250444-nexus-hip-stem-fda-510k.jpg K250444 - NEXUS® Hip Stem K250444 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Microport Orthopedics, Inc.. Cleared May 2025. https://www.510kdatabase.net/k250451/ 2025-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k250451-neuraxis-ib-stim-01-1020-fda-510k.jpg K250451 - NeurAxis IB-Stim (01-1020) K250451 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Neuraxis. Cleared May 2025. https://www.510kdatabase.net/k250454/ 2025-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k250454-hardydisk-aztreonamavibactam-3020g-aza50-fda-510k.jpg K250454 - HardyDisk Aztreonam/Avibactam 30/20µg (AZA50) K250454 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Hardy Diagnostics. Cleared May 2025. https://www.510kdatabase.net/k251156/ 2025-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k251156-npseal-fda-510k.jpg K251156 - NPseal K251156 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Guard Medical, Inc.. Cleared May 2025. https://www.510kdatabase.net/k251186/ 2025-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k251186-bard-temporary-pacing-electrode-fda-510k.jpg K251186 - Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) K251186 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 2025. https://www.510kdatabase.net/k242072/ 2025-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k242072-ceraroot-tl-implant-system-tl-fda-510k.jpg K242072 - CeraRoot TL Implant System (TL) K242072 is a FDA 510(k) cleared dental medical device. Manufacturer: Ceraroot SL. Cleared May 2025. https://www.510kdatabase.net/k242437/ 2025-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k242437-smile-dx-fda-510k.jpg K242437 - Smile Dx® K242437 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cube Click, Inc.. Cleared May 2025. https://www.510kdatabase.net/k242624/ 2025-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k242624-medical-image-post-processing-software-fda-510k.jpg K242624 - Medical Image Post-processing Software (uOmnispace.CT) K242624 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k243830/ 2025-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k243830-disposable-ureteral-stent-fda-510k.jpg K243830 - Disposable ureteral stent K243830 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Shenzhen Trious Medical Technology Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k250041/ 2025-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k250041-medical-picosecond-nd-yag-laser-system-fda-510k.jpg K250041 - Medical Picosecond ND: YAG Laser System (PZ-6) K250041 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Zhengzhou PZ Laser Slim Technology Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k250405/ 2025-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k250405-nerivio-fda-510k.jpg K250405 - Nerivio K250405 is a FDA 510(k) cleared neurology medical device. Manufacturer: Theranica Bio-Electronics, Ltd.. Cleared May 2025. https://www.510kdatabase.net/k250414/ 2025-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k250414-calopix-fda-510k.jpg K250414 - CaloPix K250414 is a FDA 510(k) cleared pathology medical device. Manufacturer: Tribun Health. Cleared May 2025. https://www.510kdatabase.net/k250420/ 2025-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k250420-helios-dura-regeneration-matrix-fda-510k.jpg K250420 - Helios Dura Regeneration Matrix K250420 is a FDA 510(k) cleared neurology medical device. Manufacturer: Helios Biomedical, Inc.. Cleared May 2025. https://www.510kdatabase.net/k250533/ 2025-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k250533-magnesium-alloy-scooter-rs100-fda-510k.jpg K250533 - Magnesium alloy scooter (RS100) K250533 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Taizhou Reach Technology Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k250712/ 2025-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k250712-linkt-compression-staple-system-fda-510k.jpg K250712 - Linkt Compression Staple System K250712 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Trax Surgical. Cleared May 2025. https://www.510kdatabase.net/k250775/ 2025-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k250775-symphony-thrombectomy-system-fda-510k.jpg K250775 - Symphony™ Thrombectomy System K250775 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Imperative Care, Inc.. Cleared May 2025. https://www.510kdatabase.net/k250813/ 2025-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k250813-microletnext-2-lancing-device-fda-510k.jpg K250813 - MICROLET®NEXT 2 Lancing Device K250813 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ascensia Diabetes Care U.S., Inc.. Cleared May 2025. https://www.510kdatabase.net/k250835/ 2025-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k250835-ethicon-4000-60mm-compact-stapler-fda-510k.jpg K250835 - ETHICON 4000 60mm Compact Stapler (EC3D60C) K250835 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon Endo-Surgery, LLC. Cleared May 2025. https://www.510kdatabase.net/k251288/ 2025-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k251288-veincare-fda-510k.jpg K251288 - Veincare K251288 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wontech Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k242674/ 2025-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k242674-freedom-posterior-cervical-screws-fda-510k.jpg K242674 - Freedom Posterior Cervical Screws K242674 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Signature Orthopaedics Pty, Ltd.. Cleared May 2025. https://www.510kdatabase.net/k242762/ 2025-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k242762-aesculap-aicon-series-container-system-fda-510k.jpg K242762 - Aesculap Aicon® Series Container System K242762 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Aesculap, Inc.. Cleared May 2025. https://www.510kdatabase.net/k242808/ 2025-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k242808-aplio-i900i800i700-diagnostic-fda-510k.jpg K242808 - Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V8.5 K242808 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared May 2025. https://www.510kdatabase.net/k250418/ 2025-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k250418-ulthera-system-uc-1-control-unit-prime-fda-510k.jpg K250418 - Ulthera System (UC-1 Control Unit PRIME Model 2.1) K250418 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ulthera, Inc.. Cleared May 2025. https://www.510kdatabase.net/k250786/ 2025-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k250786-sp-endoscope-0-430600-fda-510k.jpg K250786 - SP Endoscope, 0° (430600) K250786 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared May 2025. https://www.510kdatabase.net/k251138/ 2025-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k251138-promisemed-safety-huber-needles-fda-510k.jpg K251138 - Promisemed Safety Huber Needles K251138 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Promisemed Hangzhou Meditech Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k242418/ 2025-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k242418-p-cure-proton-therapy-system-ppts-fda-510k.jpg K242418 - P-Cure Proton Therapy System (PPTS) K242418 is a FDA 510(k) cleared radiology medical device. Manufacturer: P-Cure, Ltd.. Cleared May 2025. https://www.510kdatabase.net/k242477/ 2025-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k242477-shoulder-soft-tissue-anchors-fda-510k.jpg K242477 - Shoulder Soft Tissue Anchors K242477 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Signature Orthopaedics Pty, Ltd.. Cleared May 2025. https://www.510kdatabase.net/k243509/ 2025-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k243509-archer-psi-system-fda-510k.jpg K243509 - Archer PSI System K243509 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 3D-Side. Cleared May 2025. https://www.510kdatabase.net/k243632/ 2025-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k243632-uws-angio-basic-fda-510k.jpg K243632 - uWS-Angio Basic K243632 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k244050/ 2025-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k244050-ayon-body-contouring-system-ayon-system-fda-510k.jpg K244050 - AYON Body Contouring System (AYON SYSTEM) K244050 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Apyx Medical Corporation. Cleared May 2025. https://www.510kdatabase.net/k250393/ 2025-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k250393-zircaglow-zircaglow-ht-zirconia-fda-510k.jpg K250393 - ZircaGlow & ZircaGlow HT Zirconia K250393 is a FDA 510(k) cleared dental medical device. Manufacturer: United Zirconia. Cleared May 2025. https://www.510kdatabase.net/k250421/ 2025-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k250421-inthrill-thrombectomy-system-fda-510k.jpg K250421 - InThrill™ Thrombectomy System K250421 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inari Medical, Inc.. Cleared May 2025. https://www.510kdatabase.net/k250431/ 2025-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k250431-medical-diode-laser-hair-removal-fda-510k.jpg K250431 - Medical Diode Laser Hair Removal System (MNLT-D1) K250431 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shandong Moonlight Electronics Tech Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k250592/ 2025-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k250592-nes-reprocessed-visions-pv-018-digital-fda-510k.jpg K250592 - NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700) K250592 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Northeast Scientific, Inc.. Cleared May 2025. https://www.510kdatabase.net/k250763/ 2025-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k250763-reon-fda-510k.jpg K250763 - Reon K250763 is a FDA 510(k) cleared dental medical device. Manufacturer: C.E.I.B.Med. Cleared May 2025. https://www.510kdatabase.net/k250868/ 2025-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k250868-spectralis-hraoct-and-variants-fda-510k.jpg K250868 - SPECTRALIS HRA+OCT and variants K250868 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Heidelberg Engineering GmbH. Cleared May 2025. https://www.510kdatabase.net/k250360/ 2025-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k250360-tens-and-ems-tens-and-muscle-fda-510k.jpg K250360 - TENS AND EMS (TENS and Muscle Stimulator) (JT8012C,JT8016,JT9020E,JT9026) K250360 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Jiantuo Electronics Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k250377/ 2025-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k250377-flowflex-plus-covid-19-flu-ab-home-test-fda-510k.jpg K250377 - Flowflex Plus COVID-19 + Flu A/B Home Test K250377 is a FDA 510(k) cleared microbiology medical device. Manufacturer: ACON Laboratories, Inc.. Cleared May 2025. https://www.510kdatabase.net/k241086/ 2025-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k241086-avidhrt-sense-spo2-fda-510k.jpg K241086 - Avidhrt Sense SpO2 K241086 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Avidhrt, Inc.. Cleared May 2025. https://www.510kdatabase.net/k242294/ 2025-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k242294-diasys-procalcitonin-fs-fda-510k.jpg K242294 - DiaSys Procalcitonin FS K242294 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Diasys Diagnostic Systems GmbH. Cleared May 2025. https://www.510kdatabase.net/k242388/ 2025-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k242388-lenshooke-x12-pro-semen-analysis-system-fda-510k.jpg K242388 - LensHooke X12 PRO Semen Analysis System K242388 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bonraybio Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k242392/ 2025-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k242392-path-bgc-fda-510k.jpg K242392 - PATH BGC K242392 is a FDA 510(k) cleared neurology medical device. Manufacturer: Crossroads Neurovascular, Inc.. Cleared May 2025. https://www.510kdatabase.net/k242692/ 2025-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k242692-steadiset-infusion-set-fda-510k.jpg K242692 - SteadiSet Infusion Set K242692 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Capillary Biomedical, LLC. Cleared May 2025. https://www.510kdatabase.net/k242732/ 2025-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k242732-tristel-oph-fda-510k.jpg K242732 - Tristel OPH K242732 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Tristel Solutions , Ltd.. Cleared May 2025. https://www.510kdatabase.net/k243107/ 2025-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k243107-water-solubility-human-body-lubricant-fda-510k.jpg K243107 - Water Solubility Human Body Lubricant K243107 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Dongguan Yanxuan Biotechnology Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k243230/ 2025-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k243230-second-opinion-ble-fda-510k.jpg K243230 - Second Opinion® BLE K243230 is a FDA 510(k) cleared radiology medical device. Manufacturer: Pearl, Inc.. Cleared May 2025. https://www.510kdatabase.net/k243290/ 2025-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k243290-btl-785mj-fda-510k.jpg K243290 - BTL-785MJ K243290 is a FDA 510(k) cleared dental medical device. Manufacturer: BTL Industries, Inc.. Cleared May 2025. https://www.510kdatabase.net/k243322/ 2025-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k243322-altaviz-intravitreal-syringe-fda-510k.jpg K243322 - Altaviz Intravitreal Syringe K243322 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Altaviz, LLC. Cleared May 2025. https://www.510kdatabase.net/k243812/ 2025-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k243812-volta-af-xplorer-fda-510k.jpg K243812 - Volta AF-Xplorer K243812 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Volta Medical. Cleared May 2025. https://www.510kdatabase.net/k250053/ 2025-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k250053-tens-and-ems-tens-and-muscle-fda-510k.jpg K250053 - TENS AND EMS (TENS and Muscle Stimulator) (JT8012, JT8012B) K250053 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Jiantuo Electronics Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k250299/ 2025-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k250299-ct-mr-tandem-and-ovoid-set-fda-510k.jpg K250299 - CT/ MR Tandem and Ovoid Set K250299 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared May 2025. https://www.510kdatabase.net/k250400/ 2025-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k250400-vigeon-laparoscopic-universal-smoke-fda-510k.jpg K250400 - Vigeon Laparoscopic Universal Smoke Evacuator (VG003) K250400 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Vigeon Technology Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k250758/ 2025-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k250758-electric-wheelchair-f309-fda-510k.jpg K250758 - Electric Wheelchair (F309) K250758 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Changshu Pingfang Wheelchair Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k251103/ 2025-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k251103-verisight-intracardiac-fda-510k.jpg K251103 - VeriSight Intracardiac Echocardiography Catheter (VSICE2D) K251103 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Philips Image Guided Therapy Corporation. Cleared May 2025. https://www.510kdatabase.net/k251110/ 2025-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k251110-epiq-series-diagnostic-ultrasound-fda-510k.jpg K251110 - EPIQ Series Diagnostic Ultrasound Systems K251110 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Ultrasound, LLC. Cleared May 2025. https://www.510kdatabase.net/k251126/ 2025-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k251126-skout-system-fda-510k.jpg K251126 - SKOUT system K251126 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Iterative Health. Cleared May 2025. https://www.510kdatabase.net/k251425/ 2025-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k251425-turbodent-touch-fda-510k.jpg K251425 - turbodent touch K251425 is a FDA 510(k) cleared dental medical device. Manufacturer: Mectron S.P.A.. Cleared May 2025. https://www.510kdatabase.net/den240045/ 2025-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/den240045-teal-wand-fda-510k.jpg DEN240045 - Teal Wand DEN240045 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Teal Health, Inc.. Cleared May 2025. https://www.510kdatabase.net/k233271/ 2025-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k233271-osseone-dental-implant-system-fda-510k.jpg K233271 - OsseOne Dental Implant System K233271 is a FDA 510(k) cleared dental medical device. Manufacturer: Synoross Dba Osseone. Cleared May 2025. https://www.510kdatabase.net/k242410/ 2025-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k242410-nextstep-arthropedix-total-knee-system-fda-510k.jpg K242410 - NextStep Arthropedix Total Knee System K242410 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nextstep Arthropedix. Cleared May 2025. https://www.510kdatabase.net/k242670/ 2025-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k242670-lumify-diagnostic-ultrasound-system-fda-510k.jpg K242670 - Lumify Diagnostic Ultrasound System K242670 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Ultrasound. Cleared May 2025. https://www.510kdatabase.net/k243110/ 2025-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k243110-efoldi-navigator-powerchair-stpc-a-fda-510k.jpg K243110 - eFOLDi Navigator Powerchair (STPC-A) K243110 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Suntech UK , Ltd.. Cleared May 2025. https://www.510kdatabase.net/k243226/ 2025-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k243226-ultrasound-imaging-system-lu700-series-fda-510k.jpg K243226 - Ultrasound Imaging System (LU700 Series) K243226 is a FDA 510(k) cleared radiology medical device. Manufacturer: Leltek, Inc.. Cleared May 2025. https://www.510kdatabase.net/k243419/ 2025-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k243419-altus-spine-navigation-system-fda-510k.jpg K243419 - Altus Spine Navigation System K243419 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Altus Partners, LLC. Cleared May 2025. https://www.510kdatabase.net/k243764/ 2025-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k243764-medical-diode-laser-utu3-f7butu3-fda-510k.jpg K243764 - Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W) K243764 is a FDA 510(k) cleared dental medical device. Manufacturer: Wuhan Pioon Technology Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k243824/ 2025-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k243824-preat-abutments-fda-510k.jpg K243824 - Preat Abutments K243824 is a FDA 510(k) cleared dental medical device. Manufacturer: Preat Corporation. Cleared May 2025. https://www.510kdatabase.net/k250226/ 2025-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k250226-clarius-median-nerve-ai-fda-510k.jpg K250226 - Clarius Median Nerve AI K250226 is a FDA 510(k) cleared radiology medical device. Manufacturer: Clarius Mobile Health Corp.. Cleared May 2025. https://www.510kdatabase.net/k250482/ 2025-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k250482-advanced-anti-snoring-device-40-clear-fda-510k.jpg K250482 - Advanced Anti Snoring Device 4.0 Clear/ Advanced Anti Snoring Device 4.0 Blue K250482 is a FDA 510(k) cleared dental medical device. Manufacturer: Fissiontech, LLC. Cleared May 2025. https://www.510kdatabase.net/k250582/ 2025-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k250582-colonnade-posterior-screw-fixation-fda-510k.jpg K250582 - COLONNADE Posterior Screw Fixation System K250582 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: CG Bio Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k251133/ 2025-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k251133-avea-disposable-expiratory-filterwater-fda-510k.jpg K251133 - AVEA disposable expiratory filter/water trap (11790) K251133 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Telesair, Inc.. Cleared May 2025. https://www.510kdatabase.net/k242975/ 2025-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k242975-mobility-scooter-model-x-01-x-02-fda-510k.jpg K242975 - Mobility Scooter (Model X-01, X-02) K242975 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Wuyi Aichi Industry & Trade Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k243684/ 2025-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k243684-brightheart-view-classifier-fda-510k.jpg K243684 - BrightHeart View Classifier K243684 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brightheart. Cleared May 2025. https://www.510kdatabase.net/k243776/ 2025-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k243776-anti-neutrophil-cytoplasmic-antibodies-fda-510k.jpg K243776 - Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed) K243776 is a FDA 510(k) cleared immunology medical device. Manufacturer: Zeus Scientific. Cleared May 2025. https://www.510kdatabase.net/k250222/ 2025-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k250222-sdf-pro-fda-510k.jpg K250222 - SDF Pro K250222 is a FDA 510(k) cleared dental medical device. Manufacturer: Belport Company, Inc., Gingi-Pak. Cleared May 2025. https://www.510kdatabase.net/k251111/ 2025-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k251111-cary-fda-510k.jpg K251111 - Cary K251111 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Excitus AS. Cleared May 2025. https://www.510kdatabase.net/k251128/ 2025-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k251128-extremity-medical-external-fixation-fda-510k.jpg K251128 - Extremity Medical External Fixation System K251128 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Extremity Medical, LLC. Cleared May 2025. https://www.510kdatabase.net/k241980/ 2025-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k241980-m1-fda-510k.jpg K241980 - !M1 K241980 is a FDA 510(k) cleared radiology medical device. Manufacturer: Solutions For Tomorrow AB. Cleared May 2025. https://www.510kdatabase.net/k243017/ 2025-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k243017-ipl-hair-removal-device-nv-tm10a-nv-fda-510k.jpg K243017 - IPL Hair Removal Device (NV-TM10A, NV-TM10C, NV-TM10D) K243017 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Foshan Newface Electronic Technology Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k250160/ 2025-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k250160-ankyras-fda-510k.jpg K250160 - ANKYRAS K250160 is a FDA 510(k) cleared neurology medical device. Manufacturer: Mentice Spain S.L.. Cleared May 2025. https://www.510kdatabase.net/k250253/ 2025-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k250253-ipl-hair-removal-device-fda-510k.jpg K250253 - IPL Hair Removal Device (KCA511/KCA516/KCA522) K250253 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Dongguan Boyuan Intelligent Technology Co.,Ltd. Cleared May 2025. https://www.510kdatabase.net/k250785/ 2025-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k250785-single-use-flexible-ureteroscope-fda-510k.jpg K250785 - Single-use Flexible Ureteroscope K250785 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hunan Vathin Medical Instrument Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k251094/ 2025-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k251094-alma-veil-fda-510k.jpg K251094 - Alma Veil K251094 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wontech Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k240447/ 2025-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k240447-thermochem-ht-2000-system-and-fda-510k.jpg K240447 - ThermoChem HT-2000 System and Intraperitoneal Hyperthermia (IPH) Procedure Kit (HT-2000) K240447 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Thermasolutions, LLC. Cleared May 2025. https://www.510kdatabase.net/k242386/ 2025-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k242386-bluemoon-fda-510k.jpg K242386 - Bluemoon K242386 is a FDA 510(k) cleared dental medical device. Manufacturer: Genoss Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k242754/ 2025-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k242754-zt-clinic-mg675a-fda-510k.jpg K242754 - ZT Clinic (MG675A) K242754 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zamar Medical D.O.O.. Cleared May 2025. https://www.510kdatabase.net/k242937/ 2025-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k242937-dream-medi-sterile-surgical-gown-fda-510k.jpg K242937 - Dream Medi Sterile Surgical Gown (SurgicalGownUL) K242937 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Dae Myung Chemical Co., Ltd. (Vietnam). Cleared May 2025. https://www.510kdatabase.net/k242962/ 2025-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k242962-telemetry-monitor-5500-release-40-867232-fda-510k.jpg K242962 - Telemetry Monitor 5500 Release 4.0 (867232) K242962 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Philips Medizin Systeme B?blingen GmbH. Cleared May 2025. https://www.510kdatabase.net/k243370/ 2025-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k243370-dentatooth-fda-510k.jpg K243370 - DentaTOOTH K243370 is a FDA 510(k) cleared dental medical device. Manufacturer: Asiga Pty, Ltd.. Cleared May 2025. https://www.510kdatabase.net/k243603/ 2025-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k243603-aevicemd-fda-510k.jpg K243603 - AeviceMD K243603 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Aevice Health Pte. , Ltd.. Cleared May 2025. https://www.510kdatabase.net/k243893/ 2025-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k243893-second-opinion-pediatric-fda-510k.jpg K243893 - Second Opinion® Pediatric K243893 is a FDA 510(k) cleared radiology medical device. Manufacturer: Pearl, Inc.. Cleared May 2025. https://www.510kdatabase.net/k250728/ 2025-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k250728-arthrex-synergy-vision-endoscopic-fda-510k.jpg K250728 - Arthrex Synergy Vision Endoscopic Imaging System K250728 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Arthrex, Inc.. Cleared May 2025. https://www.510kdatabase.net/k242583/ 2025-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k242583-at-patch-atp-c130atp-c70-fda-510k.jpg K242583 - AT-Patch (ATP-C130/ATP-C70) K242583 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Atsens Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k242763/ 2025-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k242763-jetcan-pro-safety-huber-needle-fda-510k.jpg K242763 - JetCan® Pro Safety Huber Needle K242763 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Pfm Medical, Inc.. Cleared May 2025. https://www.510kdatabase.net/k242986/ 2025-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k242986-spo2-extension-cable-fda-510k.jpg K242986 - SpO2 Extension Cable K242986 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Beijing Rongrui-Century Science & Technology Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k243043/ 2025-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k243043-origin-cemented-hip-stem-fda-510k.jpg K243043 - Origin™ Cemented Hip Stem K243043 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Signature Orthopaedics Pty, Ltd.. Cleared May 2025. https://www.510kdatabase.net/k243069/ 2025-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k243069-lumys-v1-fda-510k.jpg K243069 - LUMYS (V1) K243069 is a FDA 510(k) cleared radiology medical device. Manufacturer: Intradys. Cleared May 2025. https://www.510kdatabase.net/k243114/ 2025-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k243114-sqa-iow-sperm-quality-analyzer-fda-510k.jpg K243114 - SQA-iOw Sperm Quality Analyzer K243114 is a FDA 510(k) cleared hematology medical device. Manufacturer: Medical Electronic Systems , Ltd.. Cleared May 2025. https://www.510kdatabase.net/k243457/ 2025-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k243457-nixall-antimicrobial-solutions-skin-fda-510k.jpg K243457 - Nixall Antimicrobial Solutions™ Skin & Wound Hydrogel K243457 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Seriously Clean, Ltd.. Cleared May 2025. https://www.510kdatabase.net/k243757/ 2025-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k243757-shockwave-cs-guide-catheter-fda-510k.jpg K243757 - Shockwave CS Guide Catheter K243757 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shockwave Medical, Inc.. Cleared May 2025. https://www.510kdatabase.net/k243828/ 2025-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k243828-cionic-neural-sleeve-ns-200-fda-510k.jpg K243828 - CIONIC NEURAL SLEEVE (NS-200) K243828 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Cionic, Inc.. Cleared May 2025. https://www.510kdatabase.net/k243894/ 2025-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k243894-f88-ure-sdrd-flexible-ureteroscope-fda-510k.jpg K243894 - F88 URE-SD/RD Flexible Ureteroscope K243894 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Sg Endoscopy Pte, Ltd.. Cleared May 2025. https://www.510kdatabase.net/k244001/ 2025-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k244001-karl-storz-cysto-urethro-fiberscope-fda-510k.jpg K244001 - KARL STORZ Cysto-Urethro-Fiberscope (11272CU1) K244001 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Karl Storz SE & CO. KG. Cleared May 2025. https://www.510kdatabase.net/k244014/ 2025-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k244014-i-stat-cg4-cartridge-with-the-i-stat-1-fda-510k.jpg K244014 - i-STAT CG4+ cartridge with the i-STAT 1 System K244014 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Point of Care, Inc.. Cleared May 2025. https://www.510kdatabase.net/k250161/ 2025-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k250161-wrist-blood-pressure-monitor-aoj-35a-fda-510k.jpg K250161 - Wrist Blood Pressure Monitor (AOJ-35A) K250161 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen AOJ Medical Technology Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k250292/ 2025-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k250292-osprey-midline-closed-iv-catheter-fda-510k.jpg K250292 - OSPREY Midline Closed IV Catheter System (OspreyEDC-F20) K250292 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Skydance Vascular, Inc.. Cleared May 2025. https://www.510kdatabase.net/k250629/ 2025-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k250629-sutil-rich-personal-lubricant-fda-510k.jpg K250629 - Sutil Rich Personal Lubricant K250629 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Hathor Professional Skincare , Ltd.. Cleared May 2025. https://www.510kdatabase.net/k251048/ 2025-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k251048-rapicide-pa-high-level-disinfection-fda-510k.jpg K251048 - Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118 K251048 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared May 2025. https://www.510kdatabase.net/k251056/ 2025-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k251056-anovo-instrument-arm-curved-scissors-fda-510k.jpg K251056 - Anovo Instrument ARM Curved Scissors K251056 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Momentis Surgical , Ltd.. Cleared May 2025. https://www.510kdatabase.net/k251071/ 2025-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k251071-fetal-echoscan-v11-fda-510k.jpg K251071 - Fetal EchoScan (v1.1) K251071 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brightheart. Cleared May 2025. https://www.510kdatabase.net/k242315/ 2025-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k242315-resolve-modular-revision-hip-stem-fda-510k.jpg K242315 - Resolve Modular Revision Hip Stem K242315 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: United Orthopedic Corporation. Cleared May 2025. https://www.510kdatabase.net/k243521/ 2025-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k243521-conical-ti-base-abutments-fda-510k.jpg K243521 - Conical Ti Base abutments K243521 is a FDA 510(k) cleared dental medical device. Manufacturer: BioHorizons Implant Systems, Inc.. Cleared May 2025. https://www.510kdatabase.net/k243870/ 2025-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k243870-xport-lung-preservation-system-fda-510k.jpg K243870 - X°Port Lung Preservation System K243870 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Traferox Technologies, Inc.. Cleared May 2025. https://www.510kdatabase.net/k244020/ 2025-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k244020-wrinkle-treatment-device-jm1-jm2b-fda-510k.jpg K244020 - Wrinkle Treatment Device (JM1, JM2B) K244020 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Qianyu Technology Co., Ltd.. Cleared May 2025. https://www.510kdatabase.net/k250029/ 2025-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k250029-one-tray-sealed-sterilization-fda-510k.jpg K250029 - ONE TRAY® Sealed Sterilization Container System K250029 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Innovative Sterilization Technologies. Cleared May 2025. https://www.510kdatabase.net/k250087/ 2025-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k250087-vscan-air-fda-510k.jpg K250087 - Vscan Air K250087 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared May 2025. https://www.510kdatabase.net/k250296/ 2025-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k250296-disposable-distal-attachment-d-201-fda-510k.jpg K250296 - Disposable Distal Attachment D-201 Series K250296 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared May 2025. https://www.510kdatabase.net/k250641/ 2025-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k250641-apex-3d-total-ankle-replacement-system-fda-510k.jpg K250641 - APEX 3D Total Ankle Replacement System K250641 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paragon 28, Inc.. Cleared May 2025. https://www.510kdatabase.net/k250995/ 2025-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k250995-xpert-xpress-cov-2flursv-plus-fda-510k.jpg K250995 - Xpert Xpress CoV-2/Flu/RSV plus K250995 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Cepheid. Cleared May 2025. https://www.510kdatabase.net/k250996/ 2025-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k250996-xpert-xpress-cov-2flursv-plus-fda-510k.jpg K250996 - Xpert Xpress CoV-2/Flu/RSV plus K250996 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Cepheid. Cleared May 2025. https://www.510kdatabase.net/k251007/ 2025-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k251007-crosswise-rf-transseptal-access-system-fda-510k.jpg K251007 - CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F) K251007 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Circa Scientific, Inc.. Cleared May 2025. https://www.510kdatabase.net/k251014/ 2025-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k251014-apro-45-catheter-fda-510k.jpg K251014 - APRO 45 Catheter K251014 is a FDA 510(k) cleared neurology medical device. Manufacturer: Alembic, LLC. Cleared May 2025. https://www.510kdatabase.net/k243541/ 2025-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k243541-lumirex-bronchoscope-fda-510k.jpg K243541 - LumiRex Bronchoscope K243541 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Contra Healthcare Solutions, LLC. Cleared Apr 2025. https://www.510kdatabase.net/k243934/ 2025-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k243934-stable-l-lumbar-interbody-system-fda-510k.jpg K243934 - Stable-L Lumbar Interbody System K243934 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nexus Spine, LLC. Cleared Apr 2025. https://www.510kdatabase.net/k243942/ 2025-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k243942-arctic-sun-stat-temperature-management-fda-510k.jpg K243942 - Arctic Sun Stat Temperature Management System K243942 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medivance, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k244000/ 2025-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k244000-arm-blood-pressure-monitor-arm-30a-fda-510k.jpg K244000 - Arm Blood Pressure Monitor (ARM-30A+) K244000 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen AOJ Medical Technology Co., Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k250274/ 2025-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k250274-etest-imipenemrelebactam-p-aeruginosa-fda-510k.jpg K250274 - ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL) K250274 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Biomerieux S.A.. Cleared Apr 2025. https://www.510kdatabase.net/k250282/ 2025-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k250282-persona-c-hr-fda-510k.jpg K250282 - Persona C HR K250282 is a FDA 510(k) cleared radiology medical device. Manufacturer: A.T.S. Applicazione Tecnologie Speciali S.R.L.. Cleared Apr 2025. https://www.510kdatabase.net/k250295/ 2025-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k250295-dentsply-sirona-titanium-bases-system-fda-510k.jpg K250295 - Dentsply Sirona Titanium Bases system K250295 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona. Cleared Apr 2025. https://www.510kdatabase.net/k250328/ 2025-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k250328-ultraextend-nx-cuw-u001s-v20-fda-510k.jpg K250328 - UltraExtend NX CUW-U001S V2.0 Ultrasound Image Analysis Program K250328 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Apr 2025. https://www.510kdatabase.net/k250497/ 2025-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k250497-additive-manufacturing-light-curing-fda-510k.jpg K250497 - Additive Manufacturing (Light Curing) Crown Bridge Resin K250497 is a FDA 510(k) cleared dental medical device. Manufacturer: Aidite (Qinhuangdao) Technology Co., Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k250683/ 2025-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k250683-resolve-fundus-camera-fda-510k.jpg K250683 - Resolve Fundus Camera K250683 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Optain Health, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k250907/ 2025-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k250907-sol-guard-tm-xtrathin-safety-pull-fda-510k.jpg K250907 - Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set K250907 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sol-Millennium Medical, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k251015/ 2025-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k251015-apro-45-catheter-and-alembic-fda-510k.jpg K251015 - APRO 45 Catheter and Alembic Aspiration Tubing K251015 is a FDA 510(k) cleared neurology medical device. Manufacturer: Alembic, LLC. Cleared Apr 2025. https://www.510kdatabase.net/k251024/ 2025-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k251024-teg-6s-hemostasis-system-citrated-k-kh-fda-510k.jpg K251024 - TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge K251024 is a FDA 510(k) cleared hematology medical device. Manufacturer: Haemonetics. Cleared Apr 2025. https://www.510kdatabase.net/k251051/ 2025-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k251051-aust-steerable-sheath-fda-510k.jpg K251051 - AuST Steerable Sheath K251051 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: CenterPoint Systems, LLC. Cleared Apr 2025. https://www.510kdatabase.net/k242211/ 2025-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k242211-puma-g-pediatric-system-fda-510k.jpg K242211 - PUMA-G Pediatric System K242211 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Coaptech, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k242255/ 2025-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k242255-qitexio-4-way-stopcock-qit014-fda-510k.jpg K242255 - Qitexio® 4-Way Stopcock (QIT014) K242255 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medex. Cleared Apr 2025. https://www.510kdatabase.net/k242354/ 2025-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k242354-allneb-fda-510k.jpg K242354 - AllNEB K242354 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Enchant Tek Co. , Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k242495/ 2025-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k242495-lma-fastrach-ett-su-fda-510k.jpg K242495 - LMA Fastrach ETT SU K242495 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Teleflex Medical. Cleared Apr 2025. https://www.510kdatabase.net/k243886/ 2025-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k243886-expresscore-biopsy-device-fda-510k.jpg K243886 - ExpressCore Biopsy Device K243886 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Inrad, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k243963/ 2025-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k243963-pediatric-plating-platform-hip-fda-510k.jpg K243963 - Pediatric Plating Platform Hip K243963 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OrthoPediatrics Corp.. Cleared Apr 2025. https://www.510kdatabase.net/k250069/ 2025-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k250069-powder-free-natural-rubber-latex-fda-510k.jpg K250069 - Powder Free Natural Rubber Latex Examination Gloves – Blue, Non-Sterile and Protein Claim Of 50 Micrograms per dm2 Or Less Protein K250069 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Comfort Rubber Gloves Industries Sdn. Bhd.. Cleared Apr 2025. https://www.510kdatabase.net/k250308/ 2025-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k250308-hair-growth-device-kca441-200-kca441-fda-510k.jpg K250308 - Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S) K250308 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Dongguan Boyuan Intelligent Technology Co.,Ltd. Cleared Apr 2025. https://www.510kdatabase.net/k250617/ 2025-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k250617-apex-flex-fda-510k.jpg K250617 - Apex Flex K250617 is a FDA 510(k) cleared dental medical device. Manufacturer: Sprintray, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k250962/ 2025-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k250962-apro-55-intermediate-catheter-fda-510k.jpg K250962 - APRO 55 Intermediate Catheter K250962 is a FDA 510(k) cleared neurology medical device. Manufacturer: Alembic, LLC. Cleared Apr 2025. https://www.510kdatabase.net/k241663/ 2025-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k241663-eminent-spine-3d-titanium-pedicle-fda-510k.jpg K241663 - Eminent Spine 3D Titanium Pedicle Screw System K241663 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Eminent Spine. Cleared Apr 2025. https://www.510kdatabase.net/k242951/ 2025-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k242951-diode-laser-hair-removal-machine-qdtm-02-fda-510k.jpg K242951 - Diode laser hair removal machine (QDTM-02) K242951 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Beijing Nubway S&T Co., Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k243376/ 2025-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k243376-uangio-aviva-cx-fda-510k.jpg K243376 - uAngio AVIVA CX K243376 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k243532/ 2025-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k243532-lumirex-ureteroscope-fda-510k.jpg K243532 - LumiRex Ureteroscope K243532 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Contra Healthcare Solutions, LLC. Cleared Apr 2025. https://www.510kdatabase.net/k243896/ 2025-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k243896-lensx-laser-system-8065998162-fda-510k.jpg K243896 - LenSx Laser System (8065998162) K243896 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Alcon Laboratories, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k250030/ 2025-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k250030-flash-ultrasound-system-5100-point-of-fda-510k.jpg K250030 - Flash Ultrasound System 5100 Point of Care K250030 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Ultrasound, LLC. Cleared Apr 2025. https://www.510kdatabase.net/k250158/ 2025-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k250158-electric-wheelchair-zh-w001zh-w002-zh-fda-510k.jpg K250158 - Electric Wheelchair (ZH-W001,ZH-W002 ,ZH-W003) K250158 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zhe Jiang Cleisman Industry and Trade Co.,Ltd. Cleared Apr 2025. https://www.510kdatabase.net/k250256/ 2025-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k250256-solo-tympanostomy-tube-device-ttd-solo-fda-510k.jpg K250256 - Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Solo+ (Solo+ Tympanostomy Tube Handpiece (Catalogue #: 12115-100-000) and Solo+ Tympanostomy Tube Cartridge (Catalogue #: 12115-200-000)) K250256 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Aventamed Dac. Cleared Apr 2025. https://www.510kdatabase.net/k250958/ 2025-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k250958-apro-55-swift-catheter-and-alembic-fda-510k.jpg K250958 - APRO 55 Swift Catheter and Alembic Aspiration Tubing K250958 is a FDA 510(k) cleared neurology medical device. Manufacturer: Alembic, LLC. Cleared Apr 2025. https://www.510kdatabase.net/k250977/ 2025-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k250977-suture-tool-system-fda-510k.jpg K250977 - Suture-TOOL System K250977 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Suturion AB. Cleared Apr 2025. https://www.510kdatabase.net/k251101/ 2025-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k251101-airo-suction-unit-airo-01-fda-510k.jpg K251101 - AIRO Suction Unit (AIRO-01) K251101 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cro, LLC. Cleared Apr 2025. https://www.510kdatabase.net/k242321/ 2025-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k242321-kosmos-fda-510k.jpg K242321 - Kosmos K242321 is a FDA 510(k) cleared radiology medical device. Manufacturer: EchoNous, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k242469/ 2025-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k242469-rfmagik-lite-fda-510k.jpg K242469 - RFMagik Lite K242469 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Agnes Medical Co., Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k243041/ 2025-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k243041-contact-forte-alpha-fda-510k.jpg K243041 - contact forte Alpha K243041 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Bhm-Tech Produktionsgesellschaft Mbh. Cleared Apr 2025. https://www.510kdatabase.net/k243082/ 2025-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k243082-infrared-thermometer-fda-510k.jpg K243082 - Infrared Thermometer K243082 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guangzhou Daxin Health Technology Co., Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k243264/ 2025-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k243264-dhf-02-hemoconcentrator-dhf-02-fda-510k.jpg K243264 - DHF 0.2 Hemoconcentrator (DHF 02) K243264 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Sorin Group Italia S.R.L.. Cleared Apr 2025. https://www.510kdatabase.net/k243400/ 2025-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k243400-cobas-liat-sars-cov-2-influenza-ab-v2-fda-510k.jpg K243400 - cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test K243400 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Molecular Systems, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k243406/ 2025-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k243406-cobas-liat-sars-cov-2-influenza-ab-rsv-fda-510k.jpg K243406 - cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test K243406 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Molecular Systems, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k243570/ 2025-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k243570-dimension-loci-thyroid-stimulating-fda-510k.jpg K243570 - Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL) K243570 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics. Cleared Apr 2025. https://www.510kdatabase.net/k243721/ 2025-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k243721-self-sealing-sterilization-pouches-fda-510k.jpg K243721 - Self Sealing Sterilization Pouches K243721 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wellmed Dental Medical Supply Co., Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k243821/ 2025-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k243821-i-cut-fda-510k.jpg K243821 - i-Cut K243821 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: A.M.I. Agency For Medical Innovations GmbH. Cleared Apr 2025. https://www.510kdatabase.net/k243855/ 2025-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k243855-bd-alaris-infusion-system-with-fda-510k.jpg K243855 - BD Alaris Infusion System with Guardrails Suite MX K243855 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Carefusion 303, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k243861/ 2025-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k243861-butterflybvm-fda-510k.jpg K243861 - butterflyBVM K243861 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Compact Medical, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k243876/ 2025-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k243876-verify-steam-integrating-indicator-fda-510k.jpg K243876 - VERIFY STEAM Integrating Indicator K243876 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Apr 2025. https://www.510kdatabase.net/k243998/ 2025-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k243998-dcx-disposable-cassette-dcx-fda-510k.jpg K243998 - DCX Disposable Cassette (DCX) K243998 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Institut Geroges Lopez. Cleared Apr 2025. https://www.510kdatabase.net/k244026/ 2025-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k244026-pal-7020-console-fda-510k.jpg K244026 - PAL 7020 Console K244026 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Microaire Surgical Instruments, LLC. Cleared Apr 2025. https://www.510kdatabase.net/k250046/ 2025-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k250046-air-compression-leg-massager-um605-fda-510k.jpg K250046 - Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM617) K250046 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Shenzhen Urion Technology Co., Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k250153/ 2025-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k250153-neu-platform-fda-510k.jpg K250153 - Neu Platform K250153 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neuhealth Digital , Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k250289/ 2025-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k250289-intracavitaryinterstitial-system-fda-510k.jpg K250289 - Intracavitary/Interstitial System K250289 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems. Cleared Apr 2025. https://www.510kdatabase.net/k250426/ 2025-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k250426-amulet-steerable-delivery-sheath-fda-510k.jpg K250426 - Amulet™ Steerable Delivery Sheath K250426 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared Apr 2025. https://www.510kdatabase.net/k250554/ 2025-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k250554-prodisc-l-instruments-fda-510k.jpg K250554 - prodisc® L Instruments K250554 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Centinel Spine, LLC. Cleared Apr 2025. https://www.510kdatabase.net/k250608/ 2025-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k250608-mako-total-knee-application-30-fda-510k.jpg K250608 - Mako Total Knee Application (3.0) K250608 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Mako Surgical Corp.. Cleared Apr 2025. https://www.510kdatabase.net/k250723/ 2025-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k250723-freedomflow-orbital-circumferential-fda-510k.jpg K250723 - FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration) K250723 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cardio Flow Inc.,. Cleared Apr 2025. https://www.510kdatabase.net/k250892/ 2025-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k250892-castleloc-pectus-bar-system-fda-510k.jpg K250892 - CastleLoc Pectus Bar System K250892 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: L & K Biomed Co., Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k250909/ 2025-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k250909-prelude-wave-hydrophilic-sheath-fda-510k.jpg K250909 - Prelude Wave Hydrophilic Sheath Introducer K250909 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k251075/ 2025-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k251075-dynamis-implant-system-fda-510k.jpg K251075 - DYNAMIS™ Implant System K251075 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Promethean Restorative, LLC. Cleared Apr 2025. https://www.510kdatabase.net/k251117/ 2025-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k251117-cervical-spine-truss-system-csts-fda-510k.jpg K251117 - Cervical Spine Truss System (CSTS) K251117 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 4Web Medical. Cleared Apr 2025. https://www.510kdatabase.net/k233337/ 2025-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k233337-freespira-breathing-system-fda-510k.jpg K233337 - Freespira Breathing System K233337 is a FDA 510(k) cleared neurology medical device. Manufacturer: Freespira, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k242214/ 2025-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k242214-sonu-fda-510k.jpg K242214 - Sonu K242214 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Sound Health Systems, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k242514/ 2025-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k242514-endo-motor-e-lite-max-e-lite-pro-e-fda-510k.jpg K242514 - Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) K242514 is a FDA 510(k) cleared dental medical device. Manufacturer: Shenzhen Rogin Medical Co., Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k242963/ 2025-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k242963-mentor-pliaform-breast-tissue-expander-fda-510k.jpg K242963 - MENTOR™ PliaForm™ Breast Tissue Expander w/ Suture Tabs K242963 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Mentor Worldwide, LLC. Cleared Apr 2025. https://www.510kdatabase.net/k242973/ 2025-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k242973-canmini-hand-and-foot-system-fda-510k.jpg K242973 - CanMINI Hand and Foot System K242973 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Canwell Medical Co., Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k243239/ 2025-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k243239-lung-ai-lai001-fda-510k.jpg K243239 - Lung AI (LAI001) K243239 is a FDA 510(k) cleared radiology medical device. Manufacturer: Exo, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k243714/ 2025-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k243714-da-vinci-sp-surgical-system-sp1098-fda-510k.jpg K243714 - da Vinci SP Surgical System (SP1098) K243714 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k243945/ 2025-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k243945-alara-bma-neuro-access-kit-alara-bman-fda-510k.jpg K243945 - ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) K243945 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: SurGenTec, LLC. Cleared Apr 2025. https://www.510kdatabase.net/k243954/ 2025-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k243954-pericross-epicardial-access-kit-fda-510k.jpg K243954 - PeriCross™ Epicardial Access Kit K243954 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Circa Scientific, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k250002/ 2025-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k250002-smart-check-o2-ma0236-fda-510k.jpg K250002 - Smart Check O2 (MA0236) K250002 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Life Spark Medical, LLC. Cleared Apr 2025. https://www.510kdatabase.net/k250116/ 2025-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k250116-arm-blood-pressure-monitor-arm-30h-fda-510k.jpg K250116 - Arm Blood Pressure Monitor (ARM-30H) K250116 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen AOJ Medical Technology Co., Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k250183/ 2025-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k250183-co2-laser-system-co2-laser-sst-l23-fda-510k.jpg K250183 - CO2 Laser System (CO2 Laser SST-L23) K250183 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Zhuozhou Summer Star Technologies Co., Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k250206/ 2025-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k250206-diode-laser-system-night-universe-fda-510k.jpg K250206 - Diode laser system (Night Universe K250206 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ivylaser (Beijing) Technology Co.,Ltd. Cleared Apr 2025. https://www.510kdatabase.net/k250262/ 2025-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k250262-go-pen-fda-510k.jpg K250262 - GO-PEN® K250262 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Go-Pen Aps. Cleared Apr 2025. https://www.510kdatabase.net/k242232/ 2025-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k242232-mpact-3d-metal-augments-ii-fda-510k.jpg K242232 - Mpact 3D Metal Augments II K242232 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Apr 2025. https://www.510kdatabase.net/k242531/ 2025-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k242531-noveos-specific-ige-sige-assay-fda-510k.jpg K242531 - NOVEOS Specific IgE (sIgE) Assay K242531 is a FDA 510(k) cleared immunology medical device. Manufacturer: Hycor Biomedical. Cleared Apr 2025. https://www.510kdatabase.net/k243326/ 2025-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k243326-dynamis-robotic-surgical-system-fda-510k.jpg K243326 - Dynamis Robotic Surgical System K243326 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: LEM Surgical AG. Cleared Apr 2025. https://www.510kdatabase.net/k243479/ 2025-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k243479-echoguide-version-1-fda-510k.jpg K243479 - EchoGuide (Version 1) K243479 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Sonavex, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k243697/ 2025-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k243697-myspine-webplanner-fda-510k.jpg K243697 - MySpine WebPlanner K243697 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medacta International S.A.. Cleared Apr 2025. https://www.510kdatabase.net/k250155/ 2025-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k250155-xpert-knee-fda-510k.jpg K250155 - Xpert Knee K250155 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Newclip Technics. Cleared Apr 2025. https://www.510kdatabase.net/k250198/ 2025-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k250198-laon-ortho-fda-510k.jpg K250198 - Laon Ortho K250198 is a FDA 510(k) cleared dental medical device. Manufacturer: Laon Medi, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k250228/ 2025-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k250228-ehertz-functional-series-diagnostic-fda-510k.jpg K250228 - eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R, eHertz S) K250228 is a FDA 510(k) cleared radiology medical device. Manufacturer: Esonic Technology (Wuhan) Co., Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k250697/ 2025-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k250697-electric-nasal-aspirator-bc026-bc025-fda-510k.jpg K250697 - Electric Nasal Aspirator (BC026, BC025, BC023) K250697 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Shenzhen Kingboom Technology Co., Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k250831/ 2025-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k250831-annalise-enterprise-fda-510k.jpg K250831 - Annalise Enterprise K250831 is a FDA 510(k) cleared radiology medical device. Manufacturer: Annalise-Ai. Cleared Apr 2025. https://www.510kdatabase.net/k250869/ 2025-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k250869-parietene-macroporous-mesh-ppm5050-fda-510k.jpg K250869 - Parietene™ Macroporous Mesh (PPM5050 ) K250869 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sofradim Production. Cleared Apr 2025. https://www.510kdatabase.net/k250944/ 2025-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k250944-nitrile-powder-free-examination-glove-fda-510k.jpg K250944 - Nitrile Powder Free Examination Glove, Blue Tested for Use with 60 Chemotherapy Drugs, Gastric Acid, Xylazine and Fentanyl K250944 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Gmp Medicare Sdn. Bhd.. Cleared Apr 2025. https://www.510kdatabase.net/k241931/ 2025-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k241931-ocumet-beacon-ocub100-fda-510k.jpg K241931 - OcuMet Beacon (OCUB100) K241931 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Ocusciences, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k242247/ 2025-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k242247-arix-femur-nail-system-fda-510k.jpg K242247 - ARIX Femur Nail System K242247 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Jeil Medical Corporation. Cleared Apr 2025. https://www.510kdatabase.net/k242542/ 2025-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k242542-medentika-cadcam-abutments-fda-510k.jpg K242542 - Medentika CAD/CAM Abutments K242542 is a FDA 510(k) cleared dental medical device. Manufacturer: Medentika GmbH. Cleared Apr 2025. https://www.510kdatabase.net/k243343/ 2025-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k243343-bd-ctgctv2-fda-510k.jpg K243343 - BD CTGCTV2 K243343 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Integrated Diagnostic Solutions/Becton,. Cleared Apr 2025. https://www.510kdatabase.net/k243386/ 2025-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k243386-ventris-intervertebral-body-fusion-fda-510k.jpg K243386 - Ventris Intervertebral Body Fusion Device K243386 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Acuity Surgical Devices, LLC. Cleared Apr 2025. https://www.510kdatabase.net/k243621/ 2025-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k243621-evoblock-perlon-fda-510k.jpg K243621 - Evoblock, Perléon K243621 is a FDA 510(k) cleared dental medical device. Manufacturer: Evoden Ind?stria Com?rcio Importa??o E Exporta??o. Cleared Apr 2025. https://www.510kdatabase.net/k243944/ 2025-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k243944-aperta-nse-pta-balloon-dilatation-fda-510k.jpg K243944 - Aperta NSE PTA Balloon Dilatation Catheter K243944 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Goodman Co., Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k250669/ 2025-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k250669-adaptix-interbody-system-with-titan-fda-510k.jpg K250669 - Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology K250669 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k242254/ 2025-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k242254-dkutting-ll-peripheral-scoring-balloon-fda-510k.jpg K242254 - D·Kutting™ LL Peripheral Scoring Balloon Dilatation Catheter K242254 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Dk Medical Technology Co., Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k243383/ 2025-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k243383-chikai-nexus-014-fda-510k.jpg K243383 - CHIKAI Nexus 014 K243383 is a FDA 510(k) cleared neurology medical device. Manufacturer: Asahi Intecc Co., Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k243508/ 2025-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k243508-wearable-breast-pump-model-s12a-fda-510k.jpg K243508 - Wearable breast pump (model S12A) K243508 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shenzhen TPH Technology Co., Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k243651/ 2025-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k243651-versaviewer-fda-510k.jpg K243651 - VersaViewer K243651 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems SCS. Cleared Apr 2025. https://www.510kdatabase.net/k243875/ 2025-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k243875-spectricept-skin-and-wound-cleanser-fda-510k.jpg K243875 - Spectricept Skin and Wound Cleanser K243875 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Spectrum Antimicrobials, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k250176/ 2025-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k250176-dand-dental-implant-system-fda-510k.jpg K250176 - DAND Dental Implant System K250176 is a FDA 510(k) cleared dental medical device. Manufacturer: D.A.N.D. Metal Industries North, Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k251196/ 2025-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k251196-composite-orthodontic-brackets-and-fda-510k.jpg K251196 - Composite Orthodontic Brackets and Buttons K251196 is a FDA 510(k) cleared dental medical device. Manufacturer: Ec Certification Service GmbH. Cleared Apr 2025. https://www.510kdatabase.net/k240355/ 2025-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k240355-frog-filter-removal-of-glass-fda-510k.jpg K240355 - FROG (Filter Removal of Glass) K240355 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Carrtech Corp. Cleared Apr 2025. https://www.510kdatabase.net/k240775/ 2025-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k240775-peribeam-pericardial-membrane-fda-510k.jpg K240775 - PeriBeam® Pericardial Membrane K240775 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Tamabio. Cleared Apr 2025. https://www.510kdatabase.net/k241188/ 2025-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k241188-acucy-influenza-ab-test-with-the-acucy-fda-510k.jpg K241188 - Acucy® Influenza A&B Test with the Acucy® 2 System K241188 is a FDA 510(k) cleared microbiology medical device. Manufacturer: SEKISUI Diagnostics, LLC. Cleared Apr 2025. https://www.510kdatabase.net/k241996/ 2025-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k241996-ultra-1040-fda-510k.jpg K241996 - ULTRA 1040 K241996 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ecoray Co., Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k242170/ 2025-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k242170-k-assay-crp-ver2-fda-510k.jpg K242170 - K-ASSAY CRP (Ver.2) K242170 is a FDA 510(k) cleared immunology medical device. Manufacturer: Kamiya Biomedical Company, LLC. Cleared Apr 2025. https://www.510kdatabase.net/k243013/ 2025-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k243013-liaison-plex-gram-negative-blood-fda-510k.jpg K243013 - LIAISON PLEX Gram-Negative Blood Culture Assay K243013 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Luminex Corporation. Cleared Apr 2025. https://www.510kdatabase.net/k243734/ 2025-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k243734-wireless-wired-x-ray-flat-panel-fda-510k.jpg K243734 - Wireless/ Wired X-Ray Flat Panel Detectors K243734 is a FDA 510(k) cleared radiology medical device. Manufacturer: Allengers Medical Systems Limited. Cleared Apr 2025. https://www.510kdatabase.net/k250146/ 2025-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k250146-sofwave-system-fda-510k.jpg K250146 - SofWave System K250146 is a FDA 510(k) cleared neurology medical device. Manufacturer: Sofwave Medical, Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k250224/ 2025-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k250224-handlite-tn19s-fda-510k.jpg K250224 - handLITE (TN19S) K250224 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: iSMART Developments, Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k250459/ 2025-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k250459-dmrx-100ml-empty-container-solution-fda-510k.jpg K250459 - DMRX 100ml Empty Container Solution K250459 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Technoflex Sas.. Cleared Apr 2025. https://www.510kdatabase.net/k250481/ 2025-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k250481-extension-feeding-set-with-enfit-fda-510k.jpg K250481 - Extension Feeding Set with ENFit™ Connectors K250481 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: SKY Medical, a.s.. Cleared Apr 2025. https://www.510kdatabase.net/k250834/ 2025-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k250834-zimmer-biomet-ceramic-heads-222mm-fda-510k.jpg K250834 - Zimmer Biomet Ceramic Heads (22.2mm diameter) K250834 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer Biomet. Cleared Apr 2025. https://www.510kdatabase.net/k250842/ 2025-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k250842-padlock-clip-eftr-kit-00713229-fda-510k.jpg K250842 - PADLOCK CLIP EFTR Kit (00713229) K250842 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: STERIS Corporation. Cleared Apr 2025. https://www.510kdatabase.net/k242056/ 2025-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k242056-miacare-delight-daily-wear-delight-1-fda-510k.jpg K242056 - miacare (DELiGHT daily wear/ DELiGHT 1-day/ CONFiDENCE Color daily wear/CONFiDENCE Color 1-day) Contact Lens with EautraSil Plus K242056 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Benq Materials Corporation. Cleared Apr 2025. https://www.510kdatabase.net/k242129/ 2025-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k242129-vitalrhythm-fda-510k.jpg K242129 - VitalRhythm K242129 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vitalconnect, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k242337/ 2025-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k242337-flowguide-fg60f-fda-510k.jpg K242337 - FlowGuide (FG60F) K242337 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Imds Operations B.V.. Cleared Apr 2025. https://www.510kdatabase.net/k242992/ 2025-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k242992-raycare-2024a-sp1-fda-510k.jpg K242992 - RayCare (2024A SP1) K242992 is a FDA 510(k) cleared radiology medical device. Manufacturer: RaySearch Laboratories AB (PUBL). Cleared Apr 2025. https://www.510kdatabase.net/k243337/ 2025-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k243337-dental-cone-beam-computed-tomography-fda-510k.jpg K243337 - Dental Cone Beam Computed Tomography System K243337 is a FDA 510(k) cleared radiology medical device. Manufacturer: Yofo Medical Technology Co., Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k243459/ 2025-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k243459-ultimate-rtms-for-ocd-m-series-fda-510k.jpg K243459 - Ultimate rTMS for OCD (M-series) K243459 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brain Ultimate, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k243460/ 2025-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k243460-ultimate-rtms-fda-510k.jpg K243460 - Ultimate rTMS K243460 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brain Ultimate, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k243750/ 2025-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k243750-simplestitch-suturing-system-fda-510k.jpg K243750 - SimpleStitch Suturing System K243750 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Envision Endoscopy. Cleared Apr 2025. https://www.510kdatabase.net/k243878/ 2025-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k243878-clarus-700-fda-510k.jpg K243878 - CLARUS (700) K243878 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Carl Zeiss Meditec, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k250270/ 2025-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k250270-luja-set-fda-510k.jpg K250270 - Luja Set K250270 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Coloplast Corp.. Cleared Apr 2025. https://www.510kdatabase.net/k250455/ 2025-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k250455-fluobeam-lx-imaging-system-fblx-fda-510k.jpg K250455 - FLUOBEAM LX Imaging System (FBLX) K250455 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Fluoptics Sas (A Getinge Group Company). Cleared Apr 2025. https://www.510kdatabase.net/k250499/ 2025-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k250499-relizorb-100300100301-fda-510k.jpg K250499 - RELiZORB (100300/100301) K250499 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Alcresta Therapeutics, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k250829/ 2025-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k250829-lacevo-wearable-breast-pump-model-s70-fda-510k.jpg K250829 - Lacevo Wearable Breast Pump (Model S70) K250829 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shenzhen TPH Technology Co., Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k250889/ 2025-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k250889-exult-knee-replacement-system-fda-510k.jpg K250889 - EXULT Knee Replacement System K250889 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corentec Co., Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/den240062/ 2025-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/den240062-minder-system-fda-510k.jpg DEN240062 - Minder System DEN240062 is a FDA 510(k) cleared neurology medical device. Manufacturer: Epi-Minder Pty, Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k241733/ 2025-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k241733-hebe-np0000763-fda-510k.jpg K241733 - HEBE (NP0000763) K241733 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Novasonix Technology S.L.. Cleared Apr 2025. https://www.510kdatabase.net/k242500/ 2025-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k242500-laralab-fda-510k.jpg K242500 - LARALAB K242500 is a FDA 510(k) cleared radiology medical device. Manufacturer: Laralab GmbH. Cleared Apr 2025. https://www.510kdatabase.net/k242647/ 2025-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k242647-mysegmenter-v200-fda-510k.jpg K242647 - MySegmenter (v2.0.0) K242647 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mysegmenter Technologies, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k242806/ 2025-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k242806-medyssey-navigation-system-fda-510k.jpg K242806 - Medyssey Navigation System K242806 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medyssey Co, Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k243513/ 2025-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k243513-dcm-pw-dcm-fda-510k.jpg K243513 - DCM (PW-DCM) K243513 is a FDA 510(k) cleared neurology medical device. Manufacturer: Pneumowave, Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k243853/ 2025-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k243853-clarius-prostate-ai-fda-510k.jpg K243853 - Clarius Prostate AI K243853 is a FDA 510(k) cleared radiology medical device. Manufacturer: Clarius Mobile Health Corp.. Cleared Apr 2025. https://www.510kdatabase.net/k250809/ 2025-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k250809-stellar-m22-fda-510k.jpg K250809 - Stellar M22 K250809 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lumenis Be, Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k250850/ 2025-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k250850-nanoxarc-x-fda-510k.jpg K250850 - Nanox.ARC X K250850 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nano-X Imaging , Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k242658/ 2025-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k242658-the-sensititre-18-24-hour-mic-or-fda-510k.jpg K242658 - The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Moxifloxacin in the dilution range of 0.008-16 ug/mL K242658 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Thermo Fisher Scientific. Cleared Apr 2025. https://www.510kdatabase.net/k242773/ 2025-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k242773-electro-lube-nxt-fda-510k.jpg K242773 - Electro Lube NXT K242773 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Steris. Cleared Apr 2025. https://www.510kdatabase.net/k242786/ 2025-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k242786-tearcare-mgx-system-fda-510k.jpg K242786 - TearCare MGX System K242786 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Sight Sciences, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k242932/ 2025-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k242932-skin-clinic-nitro-clear-wart-remover-fda-510k.jpg K242932 - Skin Clinic Nitro Clear Wart Remover K242932 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cryoconcepts LP. Cleared Apr 2025. https://www.510kdatabase.net/k243055/ 2025-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k243055-prime-dermafacial-collagen-fda-510k.jpg K243055 - Préime DermaFacial Collagen+ K243055 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: EMA Aesthetics , Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k250212/ 2025-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k250212-lapbox-power-tissue-containment-system-fda-510k.jpg K250212 - LapBox Power Tissue Containment System K250212 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ark Surgical. Cleared Apr 2025. https://www.510kdatabase.net/k250327/ 2025-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k250327-optablate-radiofrequency-rf-generator-fda-510k.jpg K250327 - OptaBlate Radiofrequency (RF) Generator System K250327 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker Instruments. Cleared Apr 2025. https://www.510kdatabase.net/k250650/ 2025-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k250650-spotlight-spotlight-duo-with-low-dose-fda-510k.jpg K250650 - SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option K250650 is a FDA 510(k) cleared radiology medical device. Manufacturer: Arineta , Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k250803/ 2025-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k250803-deepblue-multi-drug-urine-test-cup-fda-510k.jpg K250803 - Deepblue Multi-Drug Urine Test Cup K250803 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Anhui Deepblue Medical Technological Co., Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k250824/ 2025-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k250824-percuflex-ureteral-stent-fda-510k.jpg K250824 - Percuflex Ureteral Stent K250824 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Apr 2025. https://www.510kdatabase.net/k250833/ 2025-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k250833-swissmembrane-x-fda-510k.jpg K250833 - SwissMembrane X K250833 is a FDA 510(k) cleared dental medical device. Manufacturer: Geistlich Pharma AG. Cleared Apr 2025. https://www.510kdatabase.net/k243852/ 2025-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k243852-elfor-l-fda-510k.jpg K243852 - Elfor-L K243852 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Elfi-Tech , Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k250094/ 2025-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k250094-atlas-stim-headbox-nk-31-0601-0077-fda-510k.jpg K250094 - Atlas Stim Headbox (NK) (31-0601-0077) K250094 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neuralynx, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k250301/ 2025-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k250301-merge-universal-viewer-muv-fda-510k.jpg K250301 - Merge Universal Viewer (MUV) K250301 is a FDA 510(k) cleared radiology medical device. Manufacturer: Merge Healthcare Incorporated. Cleared Apr 2025. https://www.510kdatabase.net/k250402/ 2025-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k250402-avava-skin-treatment-system-fda-510k.jpg K250402 - AVAVA™ Skin Treatment System K250402 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Avava, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k250802/ 2025-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k250802-sterrad-100nx-sterilizer-with-allclear-fda-510k.jpg K250802 - STERRAD® 100NX Sterilizer with ALLClear™ Technology (10104) K250802 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Advanced Sterilization Products, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k250823/ 2025-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k250823-any-com-flow-fda-510k.jpg K250823 - Any-Com Flow K250823 is a FDA 510(k) cleared dental medical device. Manufacturer: Mediclus Co., Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k242098/ 2025-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k242098-cornaris-intravascular-imaging-system-fda-510k.jpg K242098 - Cornaris Intravascular Imaging System (P80-E) K242098 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Vivolight Medical Device & Technology Co., Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k242120/ 2025-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k242120-otoplan-fda-510k.jpg K242120 - OTOPLAN K242120 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Cascination AG. Cleared Apr 2025. https://www.510kdatabase.net/k242600/ 2025-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k242600-second-opinion-periapical-radiolucency-fda-510k.jpg K242600 - Second Opinion Periapical Radiolucency Contours K242600 is a FDA 510(k) cleared radiology medical device. Manufacturer: Pearl, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k242646/ 2025-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k242646-dental-implant-unit-fda-510k.jpg K242646 - Dental Implant Unit K242646 is a FDA 510(k) cleared dental medical device. Manufacturer: Guilin Aesthedent Medical Instruments Co., Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k242748/ 2025-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k242748-oncospace-fda-510k.jpg K242748 - Oncospace K242748 is a FDA 510(k) cleared radiology medical device. Manufacturer: Oncospace, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k242772/ 2025-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k242772-airsurgn-insufflator-10030airsurgn-fda-510k.jpg K242772 - AirSurgN Insufflator (10030/AirSurgN) K242772 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Smartsurgn, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k243044/ 2025-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k243044-alma-harmony-fda-510k.jpg K243044 - Alma Harmony K243044 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Alma Lasers, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k243260/ 2025-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k243260-fujifilm-processor-ep-8000-fda-510k.jpg K243260 - FUJIFILM Processor EP-8000 K243260 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fujifilm Corporation. Cleared Apr 2025. https://www.510kdatabase.net/k243346/ 2025-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k243346-cobas-liat-sars-cov-2-v2-nucleic-acid-fda-510k.jpg K243346 - cobas liat SARS-CoV-2 v2 nucleic acid test K243346 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Molecular Systems, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k243356/ 2025-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k243356-asiga-dentabase-fda-510k.jpg K243356 - Asiga DentaBASE K243356 is a FDA 510(k) cleared dental medical device. Manufacturer: Asiga Pty, Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k243537/ 2025-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k243537-xelitemed-vertehighfix-high-viscosity-fda-510k.jpg K243537 - XeliteMed VertehighFix High Viscosity Spinal Bone Cement System K243537 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Xelite Biomed , Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k243558/ 2025-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k243558-canvas-dx-fda-510k.jpg K243558 - Canvas Dx K243558 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cognoa, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k243710/ 2025-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k243710-disposable-ureteral-access-sheath-fda-510k.jpg K243710 - Disposable ureteral access sheath K243710 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Shenzhen Trious Medical Technology Co., Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k243857/ 2025-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k243857-flexible-ureterorenoscope-us27f-12-eu-fda-510k.jpg K243857 - Flexible Ureterorenoscope (US27F-12-EU K243857 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Shanghai AnQing Medical Instrument Co., Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k243888/ 2025-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k243888-medline-unite-reflex-hybrid-nitinol-fda-510k.jpg K243888 - Medline UNITE® REFLEX® Hybrid Nitinol Implant System K243888 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medline Industries, LP. Cleared Apr 2025. https://www.510kdatabase.net/k243898/ 2025-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k243898-chlorine-sentinel-ii-fda-510k.jpg K243898 - Chlorine Sentinel II K243898 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Nelson Environmental Technologies, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k243921/ 2025-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k243921-led-curing-lights-db686-halo-fda-510k.jpg K243921 - LED Curing Lights (DB686 HALO) K243921 is a FDA 510(k) cleared dental medical device. Manufacturer: Foshan Coxo Medical Instrument Co., Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k250081/ 2025-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k250081-atlantis-abutments-in-titanium-fda-510k.jpg K250081 - Atlantis® Abutments in Titanium K250081 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona. Cleared Apr 2025. https://www.510kdatabase.net/k250416/ 2025-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k250416-gbrain-mri-fda-510k.jpg K250416 - GBrain MRI K250416 is a FDA 510(k) cleared radiology medical device. Manufacturer: Galileo Cds, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k250438/ 2025-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k250438-coopersurgical-milex-pessaries-fda-510k.jpg K250438 - CooperSurgical Milex® Pessaries K250438 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: CooperSurgical, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k250748/ 2025-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k250748-klaxon-twist-fda-510k.jpg K250748 - KLAXON (TWIST) K250748 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Klaxon Mobility GmbH. Cleared Apr 2025. https://www.510kdatabase.net/k250811/ 2025-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k250811-dental-zirconia-ceramic-fda-510k.jpg K250811 - Dental Zirconia Ceramic K250811 is a FDA 510(k) cleared dental medical device. Manufacturer: Aidite (Qinhuangdao) Technology Co., Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/den240064/ 2025-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/den240064-ct-132-fda-510k.jpg DEN240064 - CT-132 DEN240064 is a FDA 510(k) cleared neurology medical device. Manufacturer: Click Therapeutics, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k242045/ 2025-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k242045-initia-t3-acetabular-hemispherical-fda-510k.jpg K242045 - Initia T3 Acetabular Hemispherical Shell System K242045 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Kyocera Medical Technologies, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k242089/ 2025-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k242089-vitrification-freeze-kit-rfd-0101-fda-510k.jpg K242089 - Vitrification Freeze Kit (RFD-0101) Vitrification Thaw Kit (RFD-0201, RFD-0202) K242089 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Jiangsu Ruifuda Medical Device Co., Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k242561/ 2025-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k242561-dewin-reproductive-media-dewin-fda-510k.jpg K242561 - Dewin Reproductive Media (Dewin Vitrification Kit, Dewin Thawing Kit) K242561 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Donnevie Medical Technology (Shanghai) Co. , Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k242928/ 2025-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k242928-tesera-k-sc-system-fda-510k.jpg K242928 - Tesera-k SC System K242928 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Kyocera Medical Technologies, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k243145/ 2025-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k243145-syngoct-lvo-detection-fda-510k.jpg K243145 - syngo.CT LVO Detection K243145 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k243240/ 2025-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k243240-vitrea-ct-vscore-fda-510k.jpg K243240 - Vitrea CT VScore K243240 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Informatics, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k243943/ 2025-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k243943-trimed-compression-screws-fda-510k.jpg K243943 - TriMed® Compression Screws K243943 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: TriMed, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k243953/ 2025-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k243953-aurora-ocufilcon-d-soft-hydrophilic-fda-510k.jpg K243953 - Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color) K243953 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Vizionfocus, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k250009/ 2025-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k250009-led-curing-light-c01-x-c02-x-fda-510k.jpg K250009 - LED Curing Light (C01-X, C02-X) K250009 is a FDA 510(k) cleared dental medical device. Manufacturer: Premium Plus (Dongguan) Limited. Cleared Apr 2025. https://www.510kdatabase.net/k250058/ 2025-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k250058-neat-001-fda-510k.jpg K250058 - NEAT 001 K250058 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brain Electrophysiology Laboratory Company, LLC. Cleared Apr 2025. https://www.510kdatabase.net/k250112/ 2025-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k250112-fitbonetm-trochanteric-fda-510k.jpg K250112 - FitboneTM Trochanteric K250112 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthofix Srl. Cleared Apr 2025. https://www.510kdatabase.net/k250177/ 2025-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k250177-epiq-series-diagnostic-ultrasound-system-fda-510k.jpg K250177 - EPIQ Series Diagnostic Ultrasound System K250177 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Ultrasound, LLC. Cleared Apr 2025. https://www.510kdatabase.net/k250371/ 2025-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k250371-cryoice-cryoxt-cryoablation-probe-cryoxt-fda-510k.jpg K250371 - cryoICE cryoXT cryoablation probe (cryoXT) K250371 is a FDA 510(k) cleared neurology medical device. Manufacturer: AtriCure, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k250389/ 2025-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k250389-xny-disposable-gastric-calibration-tube-fda-510k.jpg K250389 - XNY Disposable Gastric Calibration Tube K250389 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd. Cleared Apr 2025. https://www.510kdatabase.net/k250486/ 2025-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k250486-skyway-anterior-cervical-plate-system-fda-510k.jpg K250486 - Skyway Anterior Cervical Plate System K250486 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Kyocera Medical Technologies Inc. (KMTI). Cleared Apr 2025. https://www.510kdatabase.net/k250754/ 2025-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k250754-cmangio-v16-fda-510k.jpg K250754 - cmAngio® (V1.6) K250754 is a FDA 510(k) cleared radiology medical device. Manufacturer: Curemetrix, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k241589/ 2025-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k241589-ceribell-seizure-detection-software-fda-510k.jpg K241589 - Ceribell Seizure Detection Software K241589 is a FDA 510(k) cleared neurology medical device. Manufacturer: Ceribell, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k242429/ 2025-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k242429-centrovena-central-venous-catheter-cvc-fda-510k.jpg K242429 - CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System K242429 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton Dickinson Inc. (Bd). Cleared Apr 2025. https://www.510kdatabase.net/k243214/ 2025-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k243214-dexcom-g7-15-day-continuous-glucose-fda-510k.jpg K243214 - Dexcom G7 15 Day Continuous Glucose Monitoring System K243214 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dexcom, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k243613/ 2025-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k243613-patch-tea-model-tri-21-fda-510k.jpg K243613 - Patch-TEA (Model TRI-21) K243613 is a FDA 510(k) cleared neurology medical device. Manufacturer: Transtimulation Research, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k243743/ 2025-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k243743-autoscore-v-200-fda-510k.jpg K243743 - autoSCORE (V 2.0.0) K243743 is a FDA 510(k) cleared neurology medical device. Manufacturer: Holberg Eeg AS. Cleared Apr 2025. https://www.510kdatabase.net/k243819/ 2025-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k243819-luminopia-fda-510k.jpg K243819 - Luminopia K243819 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Luminopia, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k243966/ 2025-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k243966-faceheart-vitals-software-development-fda-510k.jpg K243966 - FaceHeart Vitals Software Development Kit (FH vitals SDK-RR) K243966 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Faceheart Corp.. Cleared Apr 2025. https://www.510kdatabase.net/k250098/ 2025-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k250098-bard-soft-mesh-fda-510k.jpg K250098 - Bard Soft Mesh K250098 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Davol, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k250373/ 2025-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k250373-prolift-expandable-spacer-system-fda-510k.jpg K250373 - ProLift Expandable Spacer System K250373 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k250752/ 2025-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k250752-aurora-surgiscope-system-asx1560-fda-510k.jpg K250752 - AURORA® Surgiscope® System (ASX15/60) K250752 is a FDA 510(k) cleared neurology medical device. Manufacturer: Integra LifeSciences Corporation. Cleared Apr 2025. https://www.510kdatabase.net/den240021/ 2025-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/den240021-tango-belt-model-sas-001-01-xs-fda-510k.jpg DEN240021 - Tango® Belt (Model SAS-001-01 (XS) DEN240021 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Active Protective Technologies, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k242151/ 2025-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k242151-radiant-renewal-skincare-wand-hd-44hd-fda-510k.jpg K242151 - Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B) K242151 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Nuon Medical Equipment Co., Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k242295/ 2025-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k242295-bunkerhill-bmd-fda-510k.jpg K242295 - BunkerHill BMD K242295 is a FDA 510(k) cleared radiology medical device. Manufacturer: BunkerHill Health. Cleared Apr 2025. https://www.510kdatabase.net/k242552/ 2025-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k242552-horos-mobile-fda-510k.jpg K242552 - Horos Mobile K242552 is a FDA 510(k) cleared radiology medical device. Manufacturer: Icat Solutions, Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k243027/ 2025-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k243027-disposable-aqueous-humor-collector-fda-510k.jpg K243027 - Disposable Aqueous Humor Collector (SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27) K243027 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hangzhou Sightnovo Medical Technology Co., Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k243722/ 2025-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k243722-pre-b-seal-lung-biopsy-plug-system-fda-510k.jpg K243722 - Pre-B Seal Lung Biopsy Plug System - 15cm Model (FG0001) K243722 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Selio Medical Limited. Cleared Apr 2025. https://www.510kdatabase.net/k243749/ 2025-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k243749-jmoon-conductive-gel-fda-510k.jpg K243749 - Jmoon Conductive Gel K243749 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Ulike Smart Electronics Co., Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k243967/ 2025-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k243967-one-nitrile-condom-fda-510k.jpg K243967 - ONE Nitrile Condom K243967 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Global Protection Corp.. Cleared Apr 2025. https://www.510kdatabase.net/k250136/ 2025-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k250136-globalcare-blood-pressure-monitor-gus610-fda-510k.jpg K250136 - Globalcare Blood Pressure Monitor (GUS610) K250136 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Globalcare Medical Technology Co., Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k250343/ 2025-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k250343-luxcreo-clear-aligner-system-fda-510k.jpg K250343 - LuxCreo Clear Aligner System K250343 is a FDA 510(k) cleared dental medical device. Manufacturer: LuxCreo, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k250366/ 2025-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k250366-electric-wheelchair-lw01301a07-fda-510k.jpg K250366 - Electric Wheelchair (LW01301A07) K250366 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Anhui Longway Medical Technology Co., Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k250708/ 2025-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k250708-npseal-fda-510k.jpg K250708 - NPseal K250708 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Guard Medical, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k250948/ 2025-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k250948-trimed-fusion-cup-system-fda-510k.jpg K250948 - TriMed Fusion Cup System K250948 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: TriMed, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k242385/ 2025-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k242385-led-therapy-mask-mn1-m226-fda-510k.jpg K242385 - LED Therapy Mask (MN1, M226) K242385 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Borria Technology Co., Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k243143/ 2025-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k243143-e-pen-e-pen-fda-510k.jpg K243143 - E-PEN (E-PEN) K243143 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bomtech Electronics Co., Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k243567/ 2025-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k243567-tyto-insights-for-rhonchi-detection-fda-510k.jpg K243567 - Tyto Insights for Rhonchi Detection K243567 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Tyto Care , Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k250033/ 2025-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k250033-smart-pulse-relief-pz-2622-pz-2622t-pz-fda-510k.jpg K250033 - Smart Pulse Relief (PZ-2622, PZ-2622T, PZ-2622E) K250033 is a FDA 510(k) cleared neurology medical device. Manufacturer: Guangzhou Pinzhi Medical Technology Co., Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k250395/ 2025-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k250395-biobrace-rc-delivery-system-fda-510k.jpg K250395 - BioBrace ® RC Delivery System K250395 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Conmed Corporation. Cleared Apr 2025. https://www.510kdatabase.net/k250425/ 2025-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k250425-ultraviolet-phototherapy-device-fda-510k.jpg K250425 - Ultraviolet Phototherapy Device K250425 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: APK Technology Co., Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k250521/ 2025-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k250521-nanobone-sbx-putty-fda-510k.jpg K250521 - NanoBone® SBX Putty K250521 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biocomposites, Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k240398/ 2025-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k240398-raystation-2023b-rayplan-2023b-fda-510k.jpg K240398 - RayStation 2023B, RayPlan 2023B, RayStation 2024A, RayPlan 2024A, RayStation 2024A SP3, RayPlan 2024A SP3 K240398 is a FDA 510(k) cleared radiology medical device. Manufacturer: RaySearch Laboratories AB (PUBL). Cleared Apr 2025. https://www.510kdatabase.net/k241982/ 2025-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k241982-deepfoqus-deepfoqus-accelerate-fda-510k.jpg K241982 - DeepFoqus (DeepFoqus-Accelerate) K241982 is a FDA 510(k) cleared radiology medical device. Manufacturer: Foqus Technologies, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k242001/ 2025-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k242001-philips-vsc-medlib-fda-510k.jpg K242001 - Philips VSC-MEDlib K242001 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Apr 2025. https://www.510kdatabase.net/k242068/ 2025-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k242068-led-light-therapy-mask-rt01-fda-510k.jpg K242068 - LED Light Therapy Mask (RT01) K242068 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ningbo Dechang Electrical Machinery Made Co.,Ltd. Cleared Apr 2025. https://www.510kdatabase.net/k242103/ 2025-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k242103-trios-ready-tip-fda-510k.jpg K242103 - TRIOS Ready Tip K242103 is a FDA 510(k) cleared dental medical device. Manufacturer: 3Shape TRIOS A/S. Cleared Apr 2025. https://www.510kdatabase.net/k242116/ 2025-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k242116-eyebox-ebx-41-fda-510k.jpg K242116 - EyeBOX EBX-4.1 K242116 is a FDA 510(k) cleared neurology medical device. Manufacturer: Oculogica, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k242209/ 2025-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k242209-uasure-ii-blood-uric-acid-monitoring-fda-510k.jpg K242209 - UASure II Blood Uric Acid Monitoring System K242209 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Apex BioTechnology Corp.. Cleared Apr 2025. https://www.510kdatabase.net/k242576/ 2025-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k242576-alltest-viral-transport-medium-fda-510k.jpg K242576 - AllTest Viral Transport Medium K242576 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Hangzhou AllTest Biotech Co., Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k242769/ 2025-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k242769-ventstar-resus-heated-n-mp17030-fda-510k.jpg K242769 - VentStar Resus heated (N) (MP17030) K242769 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Draegerwerk AG & CO Kgaa. Cleared Apr 2025. https://www.510kdatabase.net/k242807/ 2025-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k242807-heartfocus-v111-fda-510k.jpg K242807 - HeartFocus (V.1.1.1) K242807 is a FDA 510(k) cleared radiology medical device. Manufacturer: Deski. Cleared Apr 2025. https://www.510kdatabase.net/k243074/ 2025-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k243074-spectrum-spine-lumbar-cage-system-fda-510k.jpg K243074 - Spectrum Spine Lumbar Cage System K243074 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spectrum Spine, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k243236/ 2025-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k243236-whoop-ecg-electrocardiogram-feature-10-fda-510k.jpg K243236 - WHOOP ECG (electrocardiogram) Feature (1.0) K243236 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Whoop., Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k243549/ 2025-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k243549-jeti-hydrodynamic-thrombectomy-system-fda-510k.jpg K243549 - JETi Hydrodynamic Thrombectomy System K243549 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared Apr 2025. https://www.510kdatabase.net/k243581/ 2025-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k243581-k-pack-enhance-needle-kh-2713rbbtc-and-fda-510k.jpg K243581 - K-Pack Enhance Needle (KH-2713RBBTC and KH-2913RBBTC) K243581 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terumo Europe N.V.. Cleared Apr 2025. https://www.510kdatabase.net/k243691/ 2025-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k243691-liquid-051-lp-guide-catheter-extension-fda-510k.jpg K243691 - LiquID .051 LP Guide Catheter Extension K243691 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Seigla Medical, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k243769/ 2025-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k243769-qfr-30-fda-510k.jpg K243769 - QFR (3.0) K243769 is a FDA 510(k) cleared radiology medical device. Manufacturer: Qfr Solutions BV. Cleared Apr 2025. https://www.510kdatabase.net/k243786/ 2025-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k243786-bicarby-dialysate-rfp-402-rfp-402-g-fda-510k.jpg K243786 - Bicarby Dialysate RFP-402 (RFP-402-G) K243786 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC. Cleared Apr 2025. https://www.510kdatabase.net/k250011/ 2025-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k250011-turbett-surgical-instrument-pod-ts1500-fda-510k.jpg K250011 - Turbett Surgical Instrument Pod (TS1500) K250011 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Turbett Surgical. Cleared Apr 2025. https://www.510kdatabase.net/k250332/ 2025-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k250332-virage-oct-spinal-fixation-system-fda-510k.jpg K250332 - Virage® OCT Spinal Fixation System K250332 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Highridge Medical, LLC. Cleared Apr 2025. https://www.510kdatabase.net/k250656/ 2025-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k250656-medical-diode-laser-models-mz-gk-mz-fda-510k.jpg K250656 - Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75) K250656 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wuhan Pioon Technology Co., Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k250667/ 2025-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k250667-degen-medical-patient-specific-implant-fda-510k.jpg K250667 - DeGen Medical Patient Specific Implant (PSI) System K250667 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Degen Medical. Cleared Apr 2025. https://www.510kdatabase.net/k250706/ 2025-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k250706-passeo-35-xeo-peripheral-dilatation-fda-510k.jpg K250706 - Passeo-35 Xeo Peripheral Dilatation Catheter K250706 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biotronik, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k250727/ 2025-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k250727-alltest-multi-drug-rapid-urine-test-cup-fda-510k.jpg K250727 - AllTest Multi-Drug Rapid Urine Test Cup K250727 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Hangzhou AllTest Biotech Co., Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/den240031/ 2025-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/den240031-prapela-svs-hospital-bassinet-pad-fda-510k.jpg DEN240031 - Prapela SVS hospital bassinet pad (model P01) DEN240031 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Prapela, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k240615/ 2025-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k240615-leos-laser-and-endoscopy-system-fda-510k.jpg K240615 - Leos Laser and Endoscopy System K240615 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Beaver-Visitec International, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k242358/ 2025-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k242358-powered-wheelchair-mobility-robot-m4-m4u-fda-510k.jpg K242358 - Powered wheelchair (mobility robot) (M4, M4U) K242358 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Xsto Co., Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k242551/ 2025-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k242551-syngo-dynamics-version-va41d-fda-510k.jpg K242551 - syngo Dynamics (Version VA41D) K242551 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Healthcare GmbH. Cleared Apr 2025. https://www.510kdatabase.net/k243298/ 2025-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k243298-venus-ultimate-dual-venus-ultimate-fda-510k.jpg K243298 - Venus Ultimate-Dual, Venus Ultimate-Hepa, Venus Ultimate-Uro Diagnostic Ultrasound System K243298 is a FDA 510(k) cleared radiology medical device. Manufacturer: Carbon (Shenzhen) Medical Device Co., Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k243305/ 2025-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k243305-masimo-w1-fda-510k.jpg K243305 - Masimo W1 K243305 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Masimo Corporation. Cleared Apr 2025. https://www.510kdatabase.net/k243514/ 2025-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k243514-salvo-robotic-navigation-instruments-fda-510k.jpg K243514 - Salvo® Robotic Navigation Instruments K243514 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spine Wave, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k243760/ 2025-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k243760-ossiofiber-suture-anchor-25-35-mm-fda-510k.jpg K243760 - OSSIOfiber® Suture Anchor 2.5-3.5 mm K243760 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OSSIO , Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k243936/ 2025-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k243936-staclear-syringe-sc250an-fda-510k.jpg K243936 - StaClear Syringe (SC250AN) K243936 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Staclear, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k250404/ 2025-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k250404-staysafe-catheter-extension-set-with-fda-510k.jpg K250404 - stay•safe® catheter extension set with Safe- Lock, 12 inch K250404 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC. Cleared Apr 2025. https://www.510kdatabase.net/k250658/ 2025-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k250658-surefine-pen-needle-fda-510k.jpg K250658 - SureFine Pen Needle K250658 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shina Med Corporation. Cleared Apr 2025. https://www.510kdatabase.net/k241984/ 2025-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k241984-hi-d-imaging-4tavr-fda-510k.jpg K241984 - Hi-D Imaging 4TAVR K241984 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hi-D Imaging AG. Cleared Apr 2025. https://www.510kdatabase.net/k242031/ 2025-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k242031-ba-applicator-bap-gb-01-fda-510k.jpg K242031 - Béa Applicator (BAP-GB-01) K242031 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Stepone Fertility Ltd (T/A B?a Fertility). Cleared Apr 2025. https://www.510kdatabase.net/k242067/ 2025-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k242067-visera-elite-iii-video-system-center-fda-510k.jpg K242067 - VISERA ELITE III VIDEO SYSTEM CENTER OLYMPUS OTV-S700 K242067 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Olympus Corporations of the Americas. Cleared Apr 2025. https://www.510kdatabase.net/k242113/ 2025-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k242113-nerve-wrap-07-dw-001-tab-fda-510k.jpg K242113 - Nerve Wrap (07-DW-001-TAB) K242113 is a FDA 510(k) cleared neurology medical device. Manufacturer: Biocircuit Technologies, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k242114/ 2025-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k242114-plum-solo-precision-iv-pump-fda-510k.jpg K242114 - Plum Solo™ Precision IV Pump K242114 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Icu Medical, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k242115/ 2025-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k242115-plum-duo-precision-iv-pump-fda-510k.jpg K242115 - Plum Duo™ Precision IV Pump K242115 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Icu Medical, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k242117/ 2025-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k242117-lifeshield-infusion-safety-software-fda-510k.jpg K242117 - LifeShield Infusion Safety Software Suite K242117 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Icu Medical, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k242460/ 2025-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k242460-progenix-select-stim-fda-510k.jpg K242460 - Progenix Select Stim K242460 is a FDA 510(k) cleared neurology medical device. Manufacturer: Progenix, LLC. Cleared Apr 2025. https://www.510kdatabase.net/k243659/ 2025-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k243659-flash-facet-fusion-instruments-isotis-fda-510k.jpg K243659 - FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments K243659 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared Apr 2025. https://www.510kdatabase.net/k243733/ 2025-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k243733-sion-blue-plus-fda-510k.jpg K243733 - SION blue PLUS K243733 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Asahi Intecc Co., Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k243889/ 2025-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k243889-remplir-on-152-15-x-20-mm-fda-510k.jpg K243889 - Remplir (ON-152, 15 x 20 mm) K243889 is a FDA 510(k) cleared neurology medical device. Manufacturer: Orthocell, Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k250138/ 2025-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k250138-small-volume-02ml-syringe-fda-510k.jpg K250138 - Small Volume 0.2mL Syringe K250138 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Prosum Medical Limited. Cleared Apr 2025. https://www.510kdatabase.net/k250152/ 2025-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k250152-eufy-wearable-breast-pump-s1-t8d02-fda-510k.jpg K250152 - eufy Wearable Breast Pump S1 (T8D02) Model T8D02 K250152 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shenzhen TPH Technology Co., Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k250613/ 2025-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k250613-snaphammer-hammertoe-correction-system-fda-510k.jpg K250613 - SnapHammer Hammertoe Correction System K250613 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nvision Biomedical Technologies, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k250677/ 2025-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k250677-legion-total-knee-system-fda-510k.jpg K250677 - LEGION Total Knee System K250677 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k250705/ 2025-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k250705-sonata-transcervical-fibroid-ablation-fda-510k.jpg K250705 - Sonata Transcervical Fibroid Ablation System 2.2 K250705 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Gynesonics, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k250760/ 2025-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k250760-spectrum-gv-bone-cement-fda-510k.jpg K250760 - SPECTRUM GV Bone Cement K250760 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteoremedies, LLC. Cleared Apr 2025. https://www.510kdatabase.net/k250930/ 2025-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k250930-twiist-system-fda-510k.jpg K250930 - twiist system K250930 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Deka Research & Development Corp.. Cleared Apr 2025. https://www.510kdatabase.net/k242041/ 2025-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k242041-stopwet-iontophoresis-apparatus-sw01-fda-510k.jpg K242041 - STOPWET iontophoresis apparatus (SW01) K242041 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Taiwan Medical Electronics Co., Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k242105/ 2025-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k242105-saba-tampons-fda-510k.jpg K242105 - SABA Tampons K242105 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Essity Higiene Y Salud Mexico. S.A. DE C.V.. Cleared Apr 2025. https://www.510kdatabase.net/k242427/ 2025-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k242427-da-vinci-xi-surgical-system-is4000-fda-510k.jpg K242427 - da Vinci Xi Surgical System (IS4000) K242427 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k242925/ 2025-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k242925-mr-contour-dl-fda-510k.jpg K242925 - MR Contour DL K242925 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Apr 2025. https://www.510kdatabase.net/k243072/ 2025-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k243072-prime-dermafacial-microt-fda-510k.jpg K243072 - Préime DermaFacial (MicroT) K243072 is a FDA 510(k) cleared neurology medical device. Manufacturer: EMA Aesthetics , Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k243938/ 2025-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k243938-aristotle-14-guidewire-fda-510k.jpg K243938 - Aristotle 14 Guidewire K243938 is a FDA 510(k) cleared neurology medical device. Manufacturer: Scientia Vascular, Inc.. Cleared Apr 2025. https://www.510kdatabase.net/k250018/ 2025-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k250018-medical-diode-laser-systems-theia808-fda-510k.jpg K250018 - Medical Diode Laser Systems (THEIA808) K250018 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Gigaalaser Company , Ltd.. Cleared Apr 2025. https://www.510kdatabase.net/k250189/ 2025-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k250189-advatx-fda-510k.jpg K250189 - AdvaTx K250189 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Advalight Aps. Cleared Apr 2025. https://www.510kdatabase.net/k250578/ 2025-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k250578-nitrile-examination-gloves-powder-free-fda-510k.jpg K250578 - Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black) K250578 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Careglove Global Sdn. Bhd.. Cleared Apr 2025. https://www.510kdatabase.net/k250623/ 2025-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k250623-pediatric-nailing-platform-tibia-fda-510k.jpg K250623 - Pediatric Nailing Platform Tibia Pediatric Nailing Platform Femur K250623 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OrthoPediatrics Corp.. Cleared Apr 2025. https://www.510kdatabase.net/k242166/ 2025-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k242166-tribusconnect-fda-510k.jpg K242166 - TribusConnect K242166 is a FDA 510(k) cleared radiology medical device. Manufacturer: Tribusmed Beheer BV. Cleared Mar 2025. https://www.510kdatabase.net/k243178/ 2025-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k243178-digital-color-doppler-ultrasound-fda-510k.jpg K243178 - Digital Color Doppler Ultrasound Imaging System (Apogee C1) K243178 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shantou Institute of Ultrasonic Instruments Co., Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k243384/ 2025-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k243384-belzer-uw-cold-storage-solution-btlbuw-fda-510k.jpg K243384 - Belzer UW® Cold Storage Solution (BTLBUW-001) K243384 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Bridge TO Life. Cleared Mar 2025. https://www.510kdatabase.net/k250263/ 2025-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k250263-disposable-grasping-forceps-fg-52dfg-54d-fda-510k.jpg K250263 - Disposable Grasping Forceps FG-52D/FG-54D K250263 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Mar 2025. https://www.510kdatabase.net/k250663/ 2025-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k250663-niti-s-duodenal-comfort-stent-niti-s-fda-510k.jpg K250663 - Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent K250663 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Taewoong Medical Co., Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k250946/ 2025-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k250946-denture-base-resin-dt20-fda-510k.jpg K250946 - Denture Base Resin DT20 K250946 is a FDA 510(k) cleared dental medical device. Manufacturer: Hangzhou SHINING3D Dental Technology Co., Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k242618/ 2025-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k242618-layer-7-t-fda-510k.jpg K242618 - Layer 7-T K242618 is a FDA 510(k) cleared neurology medical device. Manufacturer: Precision Neuroscience, Corp.. Cleared Mar 2025. https://www.510kdatabase.net/k250601/ 2025-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k250601-neuro-omega-system-fda-510k.jpg K250601 - Neuro Omega System K250601 is a FDA 510(k) cleared neurology medical device. Manufacturer: Alpha Omega Engineering , Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k233953/ 2025-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k233953-makani-science-respiration-monitoring-fda-510k.jpg K233953 - Makani Science™ Respiration Monitoring System K233953 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Makani Science, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k234067/ 2025-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k234067-imagingring-m-version-20-fda-510k.jpg K234067 - ImagingRing m (Version 2.0) K234067 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medphoton GmbH. Cleared Mar 2025. https://www.510kdatabase.net/k241927/ 2025-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k241927-synthes-graphic-case-tray-system-fda-510k.jpg K241927 - Synthes Graphic Case & Tray System K241927 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Synthes GmbH. Cleared Mar 2025. https://www.510kdatabase.net/k242022/ 2025-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k242022-access-toxo-igg-fda-510k.jpg K242022 - Access Toxo IgG K242022 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k242952/ 2025-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k242952-innovance-antithrombin-fda-510k.jpg K242952 - INNOVANCE Antithrombin K242952 is a FDA 510(k) cleared hematology medical device. Manufacturer: Siemens Healthcare Diagnostic Products GmbH. Cleared Mar 2025. https://www.510kdatabase.net/k243228/ 2025-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k243228-flexi-seal-air-with-enfit-connector-fda-510k.jpg K243228 - Flexi-Seal AIR (with ENFit Connector) K243228 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Convatec. Cleared Mar 2025. https://www.510kdatabase.net/k243520/ 2025-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k243520-bullsai-confirm-fda-510k.jpg K243520 - Bullsai Confirm K243520 is a FDA 510(k) cleared neurology medical device. Manufacturer: Turing Medical Technologies, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k244030/ 2025-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k244030-needle-stimulator-cmns6-1-plus-cmns6-3-fda-510k.jpg K244030 - Needle Stimulator (CMNS6-1 PLUS, CMNS6-3) K244030 is a FDA 510(k) cleared neurology medical device. Manufacturer: Wuxi Jiajian Medical Instrument Co., Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k244044/ 2025-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k244044-pbc-separator-with-selux-ast-system-fda-510k.jpg K244044 - PBC Separator with Selux AST System K244044 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Selux Diagnostics, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k250571/ 2025-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k250571-catalystem-femoral-stems-fda-510k.jpg K250571 - CATALYSTEM Femoral Stems K250571 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k250596/ 2025-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k250596-arthrex-fibertak-suture-anchor-fda-510k.jpg K250596 - Arthrex FiberTak Suture Anchor K250596 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/den240020/ 2025-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/den240020-visby-medical-womens-sexual-health-test-fda-510k.jpg DEN240020 - Visby Medical Women's Sexual Health Test DEN240020 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Visby Medical, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k241785/ 2025-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k241785-starformer-m008-3t-fda-510k.jpg K241785 - StarFormer (M008-3T) K241785 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fotona D.O.O.. Cleared Mar 2025. https://www.510kdatabase.net/k241862/ 2025-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k241862-levina-pelvic-floor-muscle-stimulator-fda-510k.jpg K241862 - Levina Pelvic Floor Muscle Stimulator (RS-48) K241862 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Zmi Electronics , Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k241962/ 2025-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k241962-crossloop-fda-510k.jpg K241962 - Crossloop K241962 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Asahi Intecc Co., Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k242201/ 2025-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k242201-hypersuture-whitegreen-extension-line-fda-510k.jpg K242201 - HyperSuture White/Green Extension Line K242201 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Threadstone, LLC. Cleared Mar 2025. https://www.510kdatabase.net/k242745/ 2025-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k242745-ai-rad-companion-organs-rt-fda-510k.jpg K242745 - AI-Rad Companion Organs RT K242745 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Healthcare GmbH. Cleared Mar 2025. https://www.510kdatabase.net/k242919/ 2025-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k242919-v5med-lung-ai-fda-510k.jpg K242919 - V5med Lung AI K242919 is a FDA 510(k) cleared radiology medical device. Manufacturer: V5med, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k243038/ 2025-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k243038-salix-central-fda-510k.jpg K243038 - Salix Central K243038 is a FDA 510(k) cleared radiology medical device. Manufacturer: Artrya Limited. Cleared Mar 2025. https://www.510kdatabase.net/k243426/ 2025-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k243426-nurochek-pro-system-fda-510k.jpg K243426 - Nurochek-Pro System K243426 is a FDA 510(k) cleared neurology medical device. Manufacturer: Headsafe Mfg Pty, Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k243708/ 2025-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k243708-urology-videoscope-system-single-use-fda-510k.jpg K243708 - Urology Videoscope System (Single-use Flexible Ureteroscope: SUV-1A-B, SUV-1A-P, SUV-2A-B, SUV-2A-P, SUV-2B-B, SUB-2B-P, SUV-2C-B, SUV-2C-P K243708 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Scivita Medical Technology Co., Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k243768/ 2025-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k243768-itotal-identity-cruciate-retaining-3dp-fda-510k.jpg K243768 - iTotal® Identity™ Cruciate Retaining 3DP Porous Knee Replacement System K243768 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Restor3D, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k244046/ 2025-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k244046-edwards-esheath-optima-introducer-set-fda-510k.jpg K244046 - Edwards eSheath Optima introducer set K244046 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences. Cleared Mar 2025. https://www.510kdatabase.net/k244059/ 2025-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k244059-hydromid-5f-dual-lumen-midline-fda-510k.jpg K244059 - HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102) K244059 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Access Vascular, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k250092/ 2025-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k250092-hc-biologics-osteopoint-spinal-fda-510k.jpg K250092 - HC Biologics Osteopoint Spinal Fixation System K250092 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: HC Biologics, LLC. Cleared Mar 2025. https://www.510kdatabase.net/k250555/ 2025-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k250555-mallyad-injection-pen-adapter-mallyad-fda-510k.jpg K250555 - MallyaD injection pen adapter (MallyaD) K250555 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Biocorp Production. Cleared Mar 2025. https://www.510kdatabase.net/k250558/ 2025-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k250558-selectsite-c304-deflectable-catheter-fda-510k.jpg K250558 - SelectSite C304 Deflectable Catheter System (C304) K250558 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k240189/ 2025-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k240189-nm-01cpt-neurometer-nm-01cpt-fda-510k.jpg K240189 - NM-01/CPT neurometer (NM-01/CPT) K240189 is a FDA 510(k) cleared neurology medical device. Manufacturer: Mde Orvosbiol?giai Kutat?, Fejleszto,. Cleared Mar 2025. https://www.510kdatabase.net/k241855/ 2025-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k241855-sb-knife-jr2-md-47702-and-md-47702l-fda-510k.jpg K241855 - SB Knife Jr2 (MD-47702 and MD-47702L) K241855 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Sb-Kawasumi Laboratories, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k242669/ 2025-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k242669-snapshotglo-kb100-fda-510k.jpg K242669 - SnapshotGLO (KB100) K242669 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Kent Imaging, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k243831/ 2025-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k243831-rayvolve-ln-fda-510k.jpg K243831 - Rayvolve LN K243831 is a FDA 510(k) cleared radiology medical device. Manufacturer: AZmed. Cleared Mar 2025. https://www.510kdatabase.net/k243840/ 2025-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k243840-belzer-mps-uw-machine-perfusion-fda-510k.jpg K243840 - Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001) K243840 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Bridge TO Life. Cleared Mar 2025. https://www.510kdatabase.net/k243891/ 2025-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k243891-earlipoint-system-fda-510k.jpg K243891 - EarliPoint System K243891 is a FDA 510(k) cleared neurology medical device. Manufacturer: Earlitec Diagnostics. Cleared Mar 2025. https://www.510kdatabase.net/k243995/ 2025-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k243995-arthrex-humeral-plating-system-and-fda-510k.jpg K243995 - Arthrex Humeral Plating System and Cerclage Button K243995 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k244003/ 2025-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k244003-electrically-powered-wheelchair-fda-510k.jpg K244003 - Electrically powered wheelchair K244003 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Kunshan Hi-Fortune Health Products Co., Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k250134/ 2025-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k250134-power-wheelchair-yh-e6011yh-e6013a-fda-510k.jpg K250134 - Power Wheelchair (YH-E6011,YH-E6013A) K250134 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Ningbo Youhuan Automation Technology Co., Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k250194/ 2025-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k250194-ice-cooling-ipl-hair-removal-device-fda-510k.jpg K250194 - Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH) K250194 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Ulike Smart Electronics Co., Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k250542/ 2025-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k250542-ac3-range-intra-aortic-balloon-pump-fda-510k.jpg K250542 - AC3™ Range™ Intra-Aortic Balloon Pump K250542 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Arrow International, LLC. Cleared Mar 2025. https://www.510kdatabase.net/k250225/ 2025-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k250225-bolt-intravascular-lithotripsy-ivl-fda-510k.jpg K250225 - Bolt Intravascular Lithotripsy (IVL) System K250225 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bolt Medical, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k250668/ 2025-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k250668-aventus-thrombectomy-system-im-2100-fda-510k.jpg K250668 - Aventus Thrombectomy System (IM-2100) K250668 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inquis Medical. Cleared Mar 2025. https://www.510kdatabase.net/k241921/ 2025-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k241921-alinity-m-bkv-fda-510k.jpg K241921 - Alinity m BKV K241921 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Molecular, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k242356/ 2025-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k242356-tidal-fusion-cage-system-fda-510k.jpg K242356 - TIDAL Fusion Cage System K242356 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Restor3D, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k242893/ 2025-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k242893-verafeye-system-verafeye-imaging-fda-510k.jpg K242893 - VERAFEYE System VERAFEYE Imaging Catheter & VERAFEYE Imaging System K242893 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Luma Vision Limited. Cleared Mar 2025. https://www.510kdatabase.net/k243052/ 2025-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k243052-glean-urodynamics-system-male-delivery-fda-510k.jpg K243052 - Glean Urodynamics System Male Delivery System (GUS-1000-M) K243052 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Bright Uro, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k243525/ 2025-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k243525-sonotap-and-sonotap-ii-fda-510k.jpg K243525 - SonoTAP and SonoTAP II K243525 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: PAJUNK GmbH Medizintechnologie. Cleared Mar 2025. https://www.510kdatabase.net/k243642/ 2025-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k243642-ultracor-twirl-breast-tissue-marker-fda-510k.jpg K243642 - UltraCor™ Twirl™ Breast Tissue Marker K243642 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bard Peripheral Vascular, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k243865/ 2025-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k243865-aero-mis-facet-fusion-system-fda-510k.jpg K243865 - AERO MIS Facet Fusion System K243865 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aurora Spine. Cleared Mar 2025. https://www.510kdatabase.net/k243930/ 2025-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k243930-sonopet-iq-ultrasonic-aspirator-system-fda-510k.jpg K243930 - Sonopet iQ Ultrasonic Aspirator System (5500-050-000) K243930 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker Instruments. Cleared Mar 2025. https://www.510kdatabase.net/k243991/ 2025-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k243991-klassic-knee-system-revision-tibial-fda-510k.jpg K243991 - Klassic Knee System - Revision Tibial Baseplate K243991 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Total Joint Othopedics, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k250013/ 2025-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k250013-ventiv-7fr-12fr-mp-mechanical-fda-510k.jpg K250013 - VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP60S, VS8-MP90S, VS8-MP100B, VS10-MP100B, VS11-MP60S, VS11-MP90S, VS12-MP100B, 7F-MP60S, 7F-MP90S, 8F-MP60S, 8F-MP100B, 10F-MP100B, 11F-MP60S, 11F-MP90S, 11P-MP60S, 11P-MP90S, 12F-MP100B, V30-ASP) K250013 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Control Medical Technology, Inc. / Dba Ventiv Scientific. Cleared Mar 2025. https://www.510kdatabase.net/k250125/ 2025-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k250125-lmnt-o2-fda-510k.jpg K250125 - LMNT O2 K250125 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Xplr , Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k250182/ 2025-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k250182-innovasis-navigation-instruments-fda-510k.jpg K250182 - Innovasis Navigation Instruments K250182 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Innovasis, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k250603/ 2025-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k250603-axtiha-stand-alone-alif-system-fda-510k.jpg K250603 - AxTiHA® Stand-Alone ALIF System K250603 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Innovasis. Cleared Mar 2025. https://www.510kdatabase.net/k240761/ 2025-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k240761-arisure-closed-male-luer-with-spike-fda-510k.jpg K240761 - Arisure® Closed Male Luer with Spike Adapter (YM060) K240761 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Yukon Medical, LLC. Cleared Mar 2025. https://www.510kdatabase.net/k241065/ 2025-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k241065-checq-ac100-fda-510k.jpg K241065 - ChecQ (AC100) K241065 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentis Co., Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k241833/ 2025-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k241833-v-grad-fda-510k.jpg K241833 - V-GRAD K241833 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Vitromed GmbH. Cleared Mar 2025. https://www.510kdatabase.net/k241890/ 2025-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k241890-philips-holter-analysis-system-fda-510k.jpg K241890 - Philips Holter Analysis System K241890 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Philips Medizin Systeme B?blingen GmbH. Cleared Mar 2025. https://www.510kdatabase.net/k242053/ 2025-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k242053-fx-coral-40-f00009214-fda-510k.jpg K242053 - FX CorAL 40 (F00009214) K242053 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC. Cleared Mar 2025. https://www.510kdatabase.net/k242107/ 2025-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k242107-casemono-culture-cmon-fda-510k.jpg K242107 - CaseMONO™ Culture (CMON) K242107 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Casebioscience, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k242289/ 2025-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k242289-excelsior-xt-27-microcatheter-fda-510k.jpg K242289 - Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter K242289 is a FDA 510(k) cleared neurology medical device. Manufacturer: Stryker Neurovascular. Cleared Mar 2025. https://www.510kdatabase.net/k242564/ 2025-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k242564-autoclavable-cassette-glidewell-ht-fda-510k.jpg K242564 - Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit) K242564 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Prismatik Dentalcraft, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k242888/ 2025-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k242888-electrohydraulic-lithotriptor-tcs-b3-ii-fda-510k.jpg K242888 - Electrohydraulic Lithotriptor (TCS-B3-II) K242888 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k242909/ 2025-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k242909-flotrac-sensors-fda-510k.jpg K242909 - FloTrac sensors K242909 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Mar 2025. https://www.510kdatabase.net/k243032/ 2025-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k243032-ehl-probe-scdg-as-fda-510k.jpg K243032 - EHL Probe (SCDG-AS) K243032 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k243185/ 2025-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k243185-remi-remote-eeg-monitoring-system-fda-510k.jpg K243185 - REMI Remote EEG Monitoring System K243185 is a FDA 510(k) cleared neurology medical device. Manufacturer: Epitel. Cleared Mar 2025. https://www.510kdatabase.net/k243451/ 2025-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k243451-fiapc-plus-probes-fda-510k.jpg K243451 - FiAPC plus probes K243451 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Erbe Elektromedizin GmbH. Cleared Mar 2025. https://www.510kdatabase.net/k243630/ 2025-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k243630-medical-laser-system-incanto-evoline-fda-510k.jpg K243630 - Medical Laser System Incanto / Evoline Platinum /Evoline K243630 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Solar LS Cjsc. Cleared Mar 2025. https://www.510kdatabase.net/k243649/ 2025-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k243649-bd-vacutainer-multiple-sample-luer-fda-510k.jpg K243649 - BD Vacutainer® Multiple Sample Luer Adapter K243649 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson and Company. Cleared Mar 2025. https://www.510kdatabase.net/k243808/ 2025-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k243808-rayvolve-ptx-pe-fda-510k.jpg K243808 - Rayvolve PTX-PE K243808 is a FDA 510(k) cleared radiology medical device. Manufacturer: AZmed. Cleared Mar 2025. https://www.510kdatabase.net/k243958/ 2025-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k243958-consolidated-operating-room-equipment-fda-510k.jpg K243958 - Consolidated Operating Room Equipment (CORE) 2 Console K243958 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Instruments. Cleared Mar 2025. https://www.510kdatabase.net/k243980/ 2025-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k243980-arvis-surgical-navigation-system-fda-510k.jpg K243980 - ARVIS Surgical Navigation System K243980 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Kico Knee Innovation Company Pty Limited. Cleared Mar 2025. https://www.510kdatabase.net/k250106/ 2025-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k250106-signos-glucose-monitoring-system-fda-510k.jpg K250106 - Signos Glucose Monitoring System K250106 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Signos, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k250186/ 2025-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k250186-golif-lumbar-interbody-fusion-system-fda-510k.jpg K250186 - GoLIF! Lumbar Interbody Fusion System K250186 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Getset Surgical, SA. Cleared Mar 2025. https://www.510kdatabase.net/k250403/ 2025-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k250403-catamaran-si-joint-fusion-system-fda-510k.jpg K250403 - Catamaran SI Joint Fusion System K250403 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tenon Medical. Cleared Mar 2025. https://www.510kdatabase.net/k250513/ 2025-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k250513-intellisep-test-cv-icg-048-fda-510k.jpg K250513 - IntelliSep Test (CV-ICG-048) K250513 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Cytovale, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k250517/ 2025-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k250517-navigator-hd-ureteral-access-sheath-fda-510k.jpg K250517 - Navigator™ HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210) K250517 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Mar 2025. https://www.510kdatabase.net/k250556/ 2025-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k250556-porous-biologic-scaffold-fda-510k.jpg K250556 - Porous Biologic Scaffold K250556 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ventris Medical. Cleared Mar 2025. https://www.510kdatabase.net/k250561/ 2025-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k250561-natural-cycles-fda-510k.jpg K250561 - Natural Cycles K250561 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Natural Cycles Nordic AB. Cleared Mar 2025. https://www.510kdatabase.net/k241704/ 2025-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k241704-endoscopic-water-pump-fda-510k.jpg K241704 - Endoscopic Water Pump K241704 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hangzhou AGS MedTech Co., Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k241884/ 2025-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k241884-hpm38-polymacon-daily-wear-soft-fda-510k.jpg K241884 - HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens (HPM38) K241884 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Hunan Haipuming Technology Co., Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k241961/ 2025-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k241961-vent-creativity-knee-v10-hermes-fda-510k.jpg K241961 - Vent Creativity Knee v1.0 (Hermes) K241961 is a FDA 510(k) cleared radiology medical device. Manufacturer: Vent Creativity. Cleared Mar 2025. https://www.510kdatabase.net/k242770/ 2025-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k242770-expd-114-fda-510k.jpg K242770 - EXPD 114 K242770 is a FDA 510(k) cleared radiology medical device. Manufacturer: DRTECH Corporation. Cleared Mar 2025. https://www.510kdatabase.net/k242771/ 2025-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k242771-tesera-k-pl-system-and-tesera-k-xl-fda-510k.jpg K242771 - Tesera-k PL System and Tesera-k XL System K242771 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Kyocera Medical Technologies, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k242958/ 2025-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k242958-joylux-intimacy-gel-pg3100-fda-510k.jpg K242958 - Joylux Intimacy Gel (PG3100) K242958 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Joylux, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k243016/ 2025-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k243016-starlight-imaging-catheter-fda-510k.jpg K243016 - Starlight Imaging Catheter K243016 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Spectrawave, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k243292/ 2025-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k243292-brain-shoulder-positioning-fda-510k.jpg K243292 - brAIn™ Shoulder Positioning K243292 is a FDA 510(k) cleared radiology medical device. Manufacturer: Avatar Medical. Cleared Mar 2025. https://www.510kdatabase.net/k243922/ 2025-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k243922-revogene-fda-510k.jpg K243922 - Revogene K243922 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Meridian Bioscience, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k243928/ 2025-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k243928-viaone-epicardial-access-system-fda-510k.jpg K243928 - ViaOne Epicardial Access System K243928 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cardiovia , Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k243975/ 2025-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k243975-knee-fda-510k.jpg K243975 - Knee+ K243975 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Pixee Medical. Cleared Mar 2025. https://www.510kdatabase.net/k243988/ 2025-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k243988-rootmend-mrr-fda-510k.jpg K243988 - RootMend MRR K243988 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Riverpoint Medical, LLC. Cleared Mar 2025. https://www.510kdatabase.net/k250463/ 2025-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k250463-ameda-glo-wearable-breast-pump-model-w8s-fda-510k.jpg K250463 - Ameda GLO Wearable Breast Pump (Model W8S) K250463 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shenzhen TPH Technology Co., Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k250468/ 2025-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k250468-isleeve-introducer-set-fda-510k.jpg K250468 - iSLEEVE Introducer Set K250468 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific. Cleared Mar 2025. https://www.510kdatabase.net/k241791/ 2025-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k241791-medical-diode-laser-systems-gbox-6h-fda-510k.jpg K241791 - Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D) K241791 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Gigaalaser Company , Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k241842/ 2025-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k241842-luer-split-maj-2092-fda-510k.jpg K241842 - Luer-Split MAJ-2092 K241842 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Medical Systems Corporation. Cleared Mar 2025. https://www.510kdatabase.net/k242241/ 2025-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k242241-sunny-fda-510k.jpg K242241 - Sunny K242241 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: ShenB Co., Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k242486/ 2025-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k242486-tyber-medical-anatomical-plating-system-fda-510k.jpg K242486 - Tyber Medical Anatomical Plating System K242486 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tyber Medical, LLC. Cleared Mar 2025. https://www.510kdatabase.net/k243092/ 2025-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k243092-acupebble-ox-200-fda-510k.jpg K243092 - AcuPebble Ox (200) K243092 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Acurable Limited. Cleared Mar 2025. https://www.510kdatabase.net/k243443/ 2025-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k243443-expd-4343n1-fda-510k.jpg K243443 - EXPD 4343N1 K243443 is a FDA 510(k) cleared radiology medical device. Manufacturer: DRTECH Corporation. Cleared Mar 2025. https://www.510kdatabase.net/k243472/ 2025-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k243472-1need-pro-fda-510k.jpg K243472 - 1NEED Pro K243472 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Campomats S.R.L.. Cleared Mar 2025. https://www.510kdatabase.net/k243689/ 2025-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k243689-aview-fda-510k.jpg K243689 - AVIEW K243689 is a FDA 510(k) cleared radiology medical device. Manufacturer: Coreline Soft Co., Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k243987/ 2025-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k243987-trimed-elbow-and-forearm-system-fda-510k.jpg K243987 - TriMed Elbow and Forearm System K243987 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: TriMed, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k243999/ 2025-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k243999-trimed-ankle-fixation-system-fda-510k.jpg K243999 - TriMed Ankle Fixation System K243999 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: TriMed, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k250042/ 2025-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k250042-peekmed-web-fda-510k.jpg K250042 - PeekMed web K250042 is a FDA 510(k) cleared radiology medical device. Manufacturer: Peek Health, S.A.. Cleared Mar 2025. https://www.510kdatabase.net/k250131/ 2025-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k250131-ipl-hair-removal-device-m8011-m8012-fda-510k.jpg K250131 - IPL Hair Removal Device (M8011, M8012, M8013, M8015, M8021, M8022, M8023, M8025, M7011, M7012, M7021, M7023) K250131 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Mustech Electronics Co., Limited. Cleared Mar 2025. https://www.510kdatabase.net/k250171/ 2025-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k250171-ipl-hair-removal-device-be965a-be965b-fda-510k.jpg K250171 - IPL Hair Removal Device (BE965A, BE965B, BE965C) K250171 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Yang WO Electronic Co., Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k250210/ 2025-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k250210-broncho-videoscope-system-single-use-fda-510k.jpg K250210 - Broncho Videoscope System (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P) K250210 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Scivita Medical Technology Co., Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k250429/ 2025-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k250429-dsps-prominent-baseplate-mr-113820-fda-510k.jpg K250429 - DSPS-Prominent® baseplate, MR (113820) K250429 is a FDA 510(k) cleared radiology medical device. Manufacturer: Macromedics BV. Cleared Mar 2025. https://www.510kdatabase.net/k250502/ 2025-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k250502-safesource-direct-blue-powder-free-fda-510k.jpg K250502 - SafeSource Direct Blue Powder-Free Nitrile Exam Gloves (AMERI-TUFF Series 4000, AMERI-TOUCH Series 5000) K250502 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Safesource Direct, LLC. Cleared Mar 2025. https://www.510kdatabase.net/den240018/ 2025-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/den240018-coris-system-fda-510k.jpg DEN240018 - CORIS System DEN240018 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Nanosonics Limited. Cleared Mar 2025. https://www.510kdatabase.net/k240287/ 2025-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k240287-lyher-oral-fluid-multi-drug-test-kit-fda-510k.jpg K240287 - LYHER® Oral fluid Multi-Drug Test Kit (Cube) K240287 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Hangzhou Laihe Biotech Co., Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k240933/ 2025-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k240933-carboncool-system-fda-510k.jpg K240933 - CarbonCool® System K240933 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Global Healthcare SG Sdn. Bhd. Cleared Mar 2025. https://www.510kdatabase.net/k241729/ 2025-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k241729-hard-splint-thermo-adaptive-splint-fda-510k.jpg K241729 - Hard Splint & Thermo-Adaptive Splint K241729 is a FDA 510(k) cleared dental medical device. Manufacturer: Whip Mix Corporation. Cleared Mar 2025. https://www.510kdatabase.net/k241783/ 2025-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k241783-fortivy-osteovy-lumbar-ibf-fda-510k.jpg K241783 - FortiVy™ OsteoVy™ Lumbar IBF K241783 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Vy Spine, LLC. Cleared Mar 2025. https://www.510kdatabase.net/k241937/ 2025-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k241937-klarity-sgrt-system-arsg-e1a-arsg-e3a-fda-510k.jpg K241937 - Klarity SGRT System (ARSG-E1A, ARSG-E3A) K241937 is a FDA 510(k) cleared radiology medical device. Manufacturer: Klarity Medical & Equipment (GZ) Co., Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k242161/ 2025-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k242161-radlink-gps-pro-imaging-fda-510k.jpg K242161 - Radlink GPS Pro Imaging K242161 is a FDA 510(k) cleared radiology medical device. Manufacturer: Radlink, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k242533/ 2025-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k242533-powder-free-nitrile-patient-fda-510k.jpg K242533 - Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate K242533 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Better Care Plastic Technology Co., Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k242683/ 2025-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k242683-qp-prostate-cad-fda-510k.jpg K242683 - QP-Prostate® CAD K242683 is a FDA 510(k) cleared radiology medical device. Manufacturer: Quibim S.L.. Cleared Mar 2025. https://www.510kdatabase.net/k243553/ 2025-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k243553-quikclot-control-hemostatic-device-fda-510k.jpg K243553 - QuikClot Control+ Hemostatic Device K243553 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Teleflex Medical. Cleared Mar 2025. https://www.510kdatabase.net/k243556/ 2025-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k243556-lux-hd-35-detector-lux-hd-35-fda-510k.jpg K243556 - Lux HD 35 Detector (Lux HD 35) K243556 is a FDA 510(k) cleared radiology medical device. Manufacturer: Iray Imaging Technology (Haining) Limited. Cleared Mar 2025. https://www.510kdatabase.net/k243807/ 2025-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k243807-single-use-retrieval-basket-v-fg-fda-510k.jpg K243807 - Single Use Retrieval Basket V FG-V421PR/V422PR/V431P/V432P K243807 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Mar 2025. https://www.510kdatabase.net/k250413/ 2025-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k250413-aglaia-led-beauty-device-bp-d2309-fda-510k.jpg K250413 - Aglaia LED Beauty Device (BP-D2309) K250413 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Perfect Idea Technology Limited. Cleared Mar 2025. https://www.510kdatabase.net/k250494/ 2025-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k250494-the-osteocentric-bone-plate-and-screw-fda-510k.jpg K250494 - The OsteoCentric Bone Plate and Screw System K250494 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OsteoCentric Technologies. Cleared Mar 2025. https://www.510kdatabase.net/k241975/ 2025-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k241975-serv-medical-cdss-fda-510k.jpg K241975 - SERV MEDICAL CDSS K241975 is a FDA 510(k) cleared radiology medical device. Manufacturer: Serv Medical Pte., Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k242140/ 2025-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k242140-air-compression-leg-massager-k-705-fda-510k.jpg K242140 - Air Compression Leg Massager (K-705) K242140 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Jiale Health Technology Shenzhen Co., Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k243504/ 2025-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k243504-maia-ahmacme001-fda-510k.jpg K243504 - MAIA (AHMACME001) K243504 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Centervue S.P.A.. Cleared Mar 2025. https://www.510kdatabase.net/k243646/ 2025-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k243646-ziehm-solo-fd-fda-510k.jpg K243646 - Ziehm Solo FD K243646 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ziehm Imaging GmbH. Cleared Mar 2025. https://www.510kdatabase.net/k243802/ 2025-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k243802-aprevo-anterior-and-lateral-lumbar-fda-510k.jpg K243802 - aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device with interfixation K243802 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Carlsmed, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k243862/ 2025-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k243862-lvivo-software-application-fda-510k.jpg K243862 - LVivo Software Application K243862 is a FDA 510(k) cleared radiology medical device. Manufacturer: Dia Imaging Analysis, Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k243867/ 2025-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k243867-lagis-suction-irrigation-system-fda-510k.jpg K243867 - LAGIS Suction Irrigation System K243867 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lagis Enterprise Co., Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k243869/ 2025-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k243869-horizon-30-tms-therapy-system-horizon-fda-510k.jpg K243869 - Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire) K243869 is a FDA 510(k) cleared neurology medical device. Manufacturer: The Magstim Company Limited. Cleared Mar 2025. https://www.510kdatabase.net/k244056/ 2025-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k244056-doc-band-3d-fda-510k.jpg K244056 - DOC Band 3D K244056 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cranial Technologies, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k250379/ 2025-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k250379-signa-prime-elite-fda-510k.jpg K250379 - SIGNA Prime Elite K250379 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems, LLC. Cleared Mar 2025. https://www.510kdatabase.net/k250498/ 2025-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k250498-bps-wrist-fracture-system-fda-510k.jpg K250498 - BPS Wrist Fracture System K250498 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthonovis, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k250514/ 2025-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k250514-upt-series-medical-ro-water-treatment-fda-510k.jpg K250514 - UPT Series Medical RO Water Treatment System K250514 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Specialty Water Technologies, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k250439/ 2025-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k250439-catapult-guide-sheath-fda-510k.jpg K250439 - Catapult Guide Sheath K250439 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Contract Medical International, GmbH. Cleared Mar 2025. https://www.510kdatabase.net/k234012/ 2025-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k234012-vitek-compact-pro-fda-510k.jpg K234012 - VITEK COMPACT PRO K234012 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k241765/ 2025-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k241765-planet-onco-dose-32-fda-510k.jpg K241765 - PLANET Onco Dose (3.2) K241765 is a FDA 510(k) cleared radiology medical device. Manufacturer: Dosisoft SA. Cleared Mar 2025. https://www.510kdatabase.net/k241816/ 2025-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k241816-verteglide-spinal-growth-guidance-system-fda-510k.jpg K241816 - VerteGlide Spinal Growth Guidance System K241816 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OrthoPediatrics Corp.. Cleared Mar 2025. https://www.510kdatabase.net/k241960/ 2025-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k241960-deepresp-fda-510k.jpg K241960 - DeepRESP K241960 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nox Medical Ehf. Cleared Mar 2025. https://www.510kdatabase.net/k242010/ 2025-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k242010-bronchoscope-systemthe-single-use-fda-510k.jpg K242010 - Bronchoscope System, The Single-use Bronchoscope (Single-use Bronchoscope: SP-Y-ZQGJ2.8, SP-Y-ZQGJ3.8, SP-Y-ZQGJ4.2, SP-Y-ZQGJ4.8, SP-Y-ZQGJ5.2, SP-Y-ZQGJ5.8 K242010 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Shenzhen Sanping Image Technology Co., Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k242121/ 2025-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k242121-mbs-monogram-mbs-tka-system-fda-510k.jpg K242121 - mBôs (Monogram mBôs TKA System) K242121 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Monogram Orthopaedics, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k242244/ 2025-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k242244-viewer-fda-510k.jpg K242244 - Viewer+ K242244 is a FDA 510(k) cleared pathology medical device. Manufacturer: Lumea, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k242323/ 2025-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k242323-maestro-system-ref100-fda-510k.jpg K242323 - Maestro System (REF100) K242323 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Moon Surgical. Cleared Mar 2025. https://www.510kdatabase.net/k242811/ 2025-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k242811-bodytom-64-fda-510k.jpg K242811 - BodyTom 64 K242811 is a FDA 510(k) cleared radiology medical device. Manufacturer: Neurologica Corporation, A Subsidiary of Samsung. Cleared Mar 2025. https://www.510kdatabase.net/k243332/ 2025-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k243332-promisemed-safety-huber-needles-fda-510k.jpg K243332 - Promisemed Safety Huber Needles K243332 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Promisemed Hangzhou Meditech Co., Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k243353/ 2025-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k243353-one-fil-putty-fda-510k.jpg K243353 - One-Fil Putty K243353 is a FDA 510(k) cleared dental medical device. Manufacturer: Mediclus Co., Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k243529/ 2025-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k243529-solution-administration-sets-fda-510k.jpg K243529 - Solution Administration Sets K243529 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corporation. Cleared Mar 2025. https://www.510kdatabase.net/k243599/ 2025-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k243599-arrow-endurance-extended-dwell-fda-510k.jpg K243599 - Arrow™ Endurance™ Extended Dwell Peripheral Catheter System (EDC-00818) K243599 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Arrow International, LLC (A subsidiary of Teleflex, Inc.). Cleared Mar 2025. https://www.510kdatabase.net/k243838/ 2025-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k243838-nexxt-matrixx-si-system-fda-510k.jpg K243838 - NEXXT MATRIXX® SI System K243838 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nexxt Spine. Cleared Mar 2025. https://www.510kdatabase.net/k243931/ 2025-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k243931-cdc-human-influenza-virus-real-time-rt-fda-510k.jpg K243931 - CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2) K243931 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Centers For Disease Control and Prevention. Cleared Mar 2025. https://www.510kdatabase.net/k250025/ 2025-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k250025-porcelain-powder-enamel-fda-510k.jpg K250025 - Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid ) K250025 is a FDA 510(k) cleared dental medical device. Manufacturer: Aidite (Qinhuangdao) Technology Co., Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k250079/ 2025-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k250079-ruby-xl-system-fda-510k.jpg K250079 - Ruby XL System K250079 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Penumbra, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k250091/ 2025-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k250091-korot-blood-pressure-monitor-korot-p3-fda-510k.jpg K250091 - KOROT Blood Pressure Monitor (KOROT P3 Accurate) K250091 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Korot Co., Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k250267/ 2025-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k250267-visalys-bulk-fill-1-x-4-g-syringe-15060-fda-510k.jpg K250267 - Visalys® Bulk Fill 1 x 4 g Syringe (15060) K250267 is a FDA 510(k) cleared dental medical device. Manufacturer: Kettenbach GmbH & Co. KG. Cleared Mar 2025. https://www.510kdatabase.net/k250401/ 2025-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k250401-aion-tempshield-fda-510k.jpg K250401 - AION TempShield™ K250401 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Aion Biosystems, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k250526/ 2025-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k250526-arthrex-475-mm-double-loaded-knotless-fda-510k.jpg K250526 - Arthrex 4.75 mm Double Loaded Knotless Corkscrew Suture Anchor K250526 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k241811/ 2025-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k241811-medcad-accustride-system-fda-510k.jpg K241811 - MedCAD® AccuStride™ System K241811 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medcad. Cleared Mar 2025. https://www.510kdatabase.net/k242406/ 2025-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k242406-sioxc-cream-fda-510k.jpg K242406 - SiOxC Cream K242406 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sioxmed, LLC. Cleared Mar 2025. https://www.510kdatabase.net/k242997/ 2025-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k242997-my01-continuous-compartmental-pressure-fda-510k.jpg K242997 - MY01 Continuous Compartmental Pressure Monitor K242997 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: MY01, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k243487/ 2025-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k243487-cryofreeze-wart-and-skin-tag-remover-fda-510k.jpg K243487 - CryoFreeze Wart and Skin Tag Remover K243487 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cryosurgery, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k243735/ 2025-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k243735-ziehm-vision-fd-fda-510k.jpg K243735 - Ziehm Vision FD K243735 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ziehm Imaging GmbH. Cleared Mar 2025. https://www.510kdatabase.net/k243788/ 2025-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k243788-icecap-product-line-fda-510k.jpg K243788 - IceCap product line K243788 is a FDA 510(k) cleared neurology medical device. Manufacturer: Bioserenity Medical Devices Group. Cleared Mar 2025. https://www.510kdatabase.net/k243993/ 2025-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k243993-photon-therapy-apparatus-bl-10-fda-510k.jpg K243993 - Photon Therapy Apparatus (BL-10) K243993 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Xemis Medical Technology (Shenzhen) Co., Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k244022/ 2025-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k244022-308nm-uv-phototherapy-system-uv-k-fda-510k.jpg K244022 - 308nm UV Phototherapy System (UV-K) K244022 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Boston Aesthetics, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k250088/ 2025-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k250088-flowtriever2-catheter-fda-510k.jpg K250088 - FlowTriever2 Catheter K250088 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inari Medical, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k250113/ 2025-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k250113-neolaser-laser-surgery-fibers-fda-510k.jpg K250113 - neoLaser Laser Surgery Fibers K250113 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: G.N.S Neolaser , Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k250255/ 2025-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k250255-xvision-spine-system-fda-510k.jpg K250255 - xvision Spine system K250255 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Augmedics, Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k250380/ 2025-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k250380-surgify-halo-54085shdh1-fda-510k.jpg K250380 - Surgify Halo (54.085.SHD.H1) K250380 is a FDA 510(k) cleared neurology medical device. Manufacturer: Surgify Medical OY. Cleared Mar 2025. https://www.510kdatabase.net/k250382/ 2025-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k250382-freedom-total-knee-system-all-poly-fda-510k.jpg K250382 - Freedom Total Knee System (All-poly Tibial Plate) K250382 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Maxx Orthopedics, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k250385/ 2025-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k250385-turbo-elite-laser-atherectomy-catheter-fda-510k.jpg K250385 - Turbo-Elite Laser Atherectomy Catheter K250385 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Spectranetics. Cleared Mar 2025. https://www.510kdatabase.net/k241822/ 2025-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k241822-rewalk-7-personal-exoskeleton-50-20-0005-fda-510k.jpg K241822 - ReWalk® 7 Personal Exoskeleton (50-20-0005) K241822 is a FDA 510(k) cleared neurology medical device. Manufacturer: Rewalk Robotics Ltd. Dba Lifeward. Cleared Mar 2025. https://www.510kdatabase.net/k243746/ 2025-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k243746-delphi-amplifier-fda-510k.jpg K243746 - Delphi Amplifier K243746 is a FDA 510(k) cleared neurology medical device. Manufacturer: Quantalx Neroscience. Cleared Mar 2025. https://www.510kdatabase.net/k243763/ 2025-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k243763-wireless-tens-ems-unit-fda-510k.jpg K243763 - Wireless TENS & EMS Unit K243763 is a FDA 510(k) cleared neurology medical device. Manufacturer: Changsha Anxiang Medical Technology Co., Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k243783/ 2025-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k243783-walking-rehabilitation-training-fda-510k.jpg K243783 - Walking rehabilitation training electric wheelchair (ZW518) K243783 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Shenzhen Zuowei Technology Co., Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k243822/ 2025-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k243822-biofire-warrior-panel-fda-510k.jpg K243822 - BioFire Warrior Panel K243822 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Biofire Defense, LLC. Cleared Mar 2025. https://www.510kdatabase.net/k243849/ 2025-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k243849-2430tca-with-xmaru-w-fda-510k.jpg K243849 - 2430TCA with Xmaru W K243849 is a FDA 510(k) cleared radiology medical device. Manufacturer: Rayence Co., Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k243903/ 2025-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k243903-rct600-fda-510k.jpg K243903 - RCT600 K243903 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ray Co., Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k243957/ 2025-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k243957-picoalex-fda-510k.jpg K243957 - PICOALEX K243957 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wontech Co., Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k250411/ 2025-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k250411-dannik-laparoscopic-single-use-poly-fda-510k.jpg K250411 - DANNIK® Laparoscopic Single-Use Poly Specimen Retrieval System K250411 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Dannik, LLC. Cleared Mar 2025. https://www.510kdatabase.net/k250605/ 2025-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k250605-evol-ha-hyper-c-cervical-interbody-fda-510k.jpg K250605 - EVOL® ha – Hyper C Cervical Interbody Fusion System K250605 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Cutting Edge Spine, LLC. Cleared Mar 2025. https://www.510kdatabase.net/k241562/ 2025-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k241562-outflo-aortic-valve-dilatation-balloon-fda-510k.jpg K241562 - OutFlo Aortic Valve Dilatation Balloon Catheter K241562 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Disa Medinotec. Cleared Mar 2025. https://www.510kdatabase.net/k241725/ 2025-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k241725-better-diagnostics-caries-assist-bdca-fda-510k.jpg K241725 - Better Diagnostics Caries Assist (BDCA) Version 1.0 K241725 is a FDA 510(k) cleared radiology medical device. Manufacturer: Better Diagnostics AI Corp.. Cleared Mar 2025. https://www.510kdatabase.net/k242610/ 2025-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k242610-8mm-monopolar-curved-scissors-470179-fda-510k.jpg K242610 - 8mm Monopolar Curved Scissors (470179) K242610 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Iconocare Health. Cleared Mar 2025. https://www.510kdatabase.net/k243029/ 2025-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k243029-origin-tt-stem-fda-510k.jpg K243029 - Origin™ TT Stem K243029 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Signature Orthopaedics Pty, Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k250357/ 2025-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k250357-remunitypro-pump-for-remodulin-fda-510k.jpg K250357 - RemunityPRO™ Pump for Remodulin® (treprostinil) Injection K250357 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Deka Research & Development Corp.. Cleared Mar 2025. https://www.510kdatabase.net/k250374/ 2025-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k250374-ibur-30mm-diamond-match-head-distal-fda-510k.jpg K250374 - iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D) K250374 is a FDA 510(k) cleared neurology medical device. Manufacturer: Stryker Instruments. Cleared Mar 2025. https://www.510kdatabase.net/k250424/ 2025-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k250424-arthrex-tightrope-soft-button-rt-fda-510k.jpg K250424 - Arthrex TightRope Soft Button, RT K250424 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k241944/ 2025-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k241944-agilon-xo-shoulder-replacement-system-fda-510k.jpg K241944 - AGILON® XO Shoulder Replacement System K241944 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Implantcast GmbH. Cleared Mar 2025. https://www.510kdatabase.net/k243101/ 2025-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k243101-medline-renewal-reprocessed-siemens-fda-510k.jpg K243101 - Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ) K243101 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Surgical Instrument Service and Savings, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k243596/ 2025-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k243596-da-vinci-sp-sureform-45-staplers-and-fda-510k.jpg K243596 - da Vinci SP SureForm 45 Staplers and Reloads (SP1098) K243596 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k243676/ 2025-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k243676-duet-external-drainage-and-monitoring-fda-510k.jpg K243676 - Duet External Drainage and Monitoring System (EDMS) K243676 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Neurosurgery. Cleared Mar 2025. https://www.510kdatabase.net/k243839/ 2025-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k243839-alteon-ha-femoral-stems-fda-510k.jpg K243839 - Alteon® HA Femoral Stems K243839 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k250188/ 2025-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k250188-wound-treatment-system-vht-200-fda-510k.jpg K250188 - Wound Treatment System (VHT-200) K250188 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Vaporox, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k241159/ 2025-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k241159-handbike-batec-electric-fda-510k.jpg K241159 - Handbike Batec Electric K241159 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Batec Mobility, S.L.. Cleared Mar 2025. https://www.510kdatabase.net/k241799/ 2025-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k241799-atmos-c-051-thorax-31702000-fda-510k.jpg K241799 - ATMOS C 051 Thorax (317.0200.0) K241799 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Atmos Medizintechnik GmbH & Co. KG. Cleared Mar 2025. https://www.510kdatabase.net/k242207/ 2025-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k242207-noable-laser-fda-510k.jpg K242207 - NOABLE LASER K242207 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Daeju Meditech Engineering Co., Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k242338/ 2025-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k242338-cleerly-labs-v20-fda-510k.jpg K242338 - Cleerly LABS (v2.0) K242338 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cleerly, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k242383/ 2025-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k242383-apex-locator-fda-510k.jpg K242383 - Apex Locator K242383 is a FDA 510(k) cleared dental medical device. Manufacturer: Shenzhen Rogin Medical Co., Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k242510/ 2025-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k242510-geistlich-bio-flow-fda-510k.jpg K242510 - Geistlich Bio-Flow® K242510 is a FDA 510(k) cleared dental medical device. Manufacturer: Geistlich Pharma AG. Cleared Mar 2025. https://www.510kdatabase.net/k242642/ 2025-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k242642-cufftrek-fda-510k.jpg K242642 - CuffTrek K242642 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shanghai Longmann Tech Co., Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k242890/ 2025-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k242890-spineart-navigation-instrument-system-fda-510k.jpg K242890 - SPINEART Navigation Instrument System K242890 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spineart SA. Cleared Mar 2025. https://www.510kdatabase.net/k242914/ 2025-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k242914-opntm-navigation-fda-510k.jpg K242914 - Op.n(TM) Navigation K242914 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ecential Robotics. Cleared Mar 2025. https://www.510kdatabase.net/k243421/ 2025-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k243421-lelo-hex-lubricated-natural-rubber-fda-510k.jpg K243421 - Lelo Hex Lubricated Natural Rubber Latex Condom K243421 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Lelo, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k243515/ 2025-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k243515-epiwatch-monitoring-system-fda-510k.jpg K243515 - EpiWatch Monitoring System K243515 is a FDA 510(k) cleared neurology medical device. Manufacturer: Epiwatch, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k243535/ 2025-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k243535-flexible-video-choledochoscope-chv-fda-510k.jpg K243535 - Flexible Video-Choledochoscope (CHV-110J-U) K243535 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Shanghai SeeGen Photoelectric Technology Co., Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k243610/ 2025-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k243610-aptus-hand-system-fda-510k.jpg K243610 - APTUS Hand System K243610 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medartis AG. Cleared Mar 2025. https://www.510kdatabase.net/k243798/ 2025-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k243798-orthex-external-fixation-system-fda-510k.jpg K243798 - Orthex External Fixation System K243798 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OrthoPediatrics Corp.. Cleared Mar 2025. https://www.510kdatabase.net/k243801/ 2025-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k243801-front-line-field-sterilizer-fl135-fda-510k.jpg K243801 - FRONT-LINE Field Sterilizer (FL135) K243801 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Fort Defiance Industries, LLC. Cleared Mar 2025. https://www.510kdatabase.net/k243970/ 2025-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k243970-portable-wheelchair-fda-510k.jpg K243970 - Portable Wheelchair K243970 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Intradin (Shanghai) Machinery Co., Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k241767/ 2025-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k241767-versacem-acetabular-shell-and-double-fda-510k.jpg K241767 - Versacem Acetabular Shell and Double Mobility HC Liners K241767 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Mar 2025. https://www.510kdatabase.net/k241790/ 2025-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k241790-xcellarispro-twist-microneedling-device-fda-510k.jpg K241790 - XCELLARISPRO TWIST microneedling device K241790 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Dermaroller GmbH. Cleared Mar 2025. https://www.510kdatabase.net/k243001/ 2025-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k243001-sterile-water-usp-and-sterile-09-fda-510k.jpg K243001 - Sterile Water USP and Sterile 0.9% Normal Saline USP K243001 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Laboratorios Biogalenic S.A. DE C.V.. Cleared Mar 2025. https://www.510kdatabase.net/k243331/ 2025-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k243331-lvivo-seamless-fda-510k.jpg K243331 - LVivo Seamless K243331 is a FDA 510(k) cleared radiology medical device. Manufacturer: Dia Imaging Analysis, Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k243578/ 2025-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k243578-bear-bridge-enhanced-acl-restoration-fda-510k.jpg K243578 - BEAR® (Bridge-Enhanced ACL Restoration) Implant K243578 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Miach Orthopaedics, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k243587/ 2025-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k243587-purelift-glow-fda-510k.jpg K243587 - PureLift GLOW K243587 is a FDA 510(k) cleared neurology medical device. Manufacturer: Xtreem Pulse, LLC. Cleared Mar 2025. https://www.510kdatabase.net/k243724/ 2025-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k243724-persona-revision-knee-system-persona-fda-510k.jpg K243724 - Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components) K243724 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k243842/ 2025-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k243842-intra-operative-positioning-system-iops-fda-510k.jpg K243842 - Intra-Operative Positioning System (IOPS®) K243842 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Centerline Biomedical, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k243871/ 2025-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k243871-philips-intellisite-pathology-solution-fda-510k.jpg K243871 - Philips IntelliSite Pathology Solution 5.1 K243871 is a FDA 510(k) cleared pathology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Mar 2025. https://www.510kdatabase.net/k250344/ 2025-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k250344-bd-phoenix-automated-microbiology-system-fda-510k.jpg K250344 - BD Phoenix™ Automated Microbiology System K250344 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson and Company. Cleared Mar 2025. https://www.510kdatabase.net/k241734/ 2025-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k241734-wellead-hydrophilic-intermittent-fda-510k.jpg K241734 - Wellead® Hydrophilic Intermittent Catheter Ready to Use K241734 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Well Lead Medical Co., Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k241770/ 2025-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k241770-prostate-mr-ai-va10a-fda-510k.jpg K241770 - Prostate MR AI (VA10A) K241770 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Healthcare GmbH. Cleared Mar 2025. https://www.510kdatabase.net/k242149/ 2025-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k242149-novosorb-mtx-fda-510k.jpg K242149 - NovoSorb® MTX K242149 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Polynovo Biomaterials Pty, Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k242190/ 2025-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k242190-access-cortisol-fda-510k.jpg K242190 - Access Cortisol K242190 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k242597/ 2025-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k242597-crosslead-0018inch-fda-510k.jpg K242597 - CROSSLEAD 0.018inch K242597 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Asahi Intecc Co., Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k243751/ 2025-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k243751-mako-total-hip-application-50-fda-510k.jpg K243751 - Mako Total Hip Application 5.0 K243751 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Mako Surgical Corp.. Cleared Mar 2025. https://www.510kdatabase.net/k250304/ 2025-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k250304-titanex-screw-systems-fda-510k.jpg K250304 - TITANEX Screw Systems K250304 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Vilex, LLC. Cleared Mar 2025. https://www.510kdatabase.net/k232383/ 2025-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k232383-iphysio-system-fda-510k.jpg K232383 - iPhysio® System K232383 is a FDA 510(k) cleared dental medical device. Manufacturer: Euroteknika. Cleared Mar 2025. https://www.510kdatabase.net/k241679/ 2025-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k241679-disposable-cytology-brush-af-series-fda-510k.jpg K241679 - Disposable Cytology Brush (AF series) K241679 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Alton (Shanghai) Medical Instruments Co., Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k243461/ 2025-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k243461-calibrate-interbody-systems-fda-510k.jpg K243461 - Calibrate Interbody Systems K243461 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k243809/ 2025-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k243809-biolox-delta-revision-heads-fda-510k.jpg K243809 - Biolox® Delta Revision heads K243809 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Limacorporate. Cleared Mar 2025. https://www.510kdatabase.net/k243933/ 2025-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k243933-ceevra-reveal-3-fda-510k.jpg K243933 - Ceevra Reveal 3+ K243933 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ceevra, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k241947/ 2025-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k241947-energylounger-ty-01-fda-510k.jpg K241947 - EnergyLounger (TY-01) K241947 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Kaiyan Medical Equipment Co., Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k242943/ 2025-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k242943-q-switched-ndyag-laser-machine-qnhf-01-fda-510k.jpg K242943 - Q Switched Nd:YAG Laser machine (QNHF-01) K242943 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Beijing Nubway S&T Co., Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k243235/ 2025-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k243235-lvivo-software-application-fda-510k.jpg K243235 - LVivo Software Application K243235 is a FDA 510(k) cleared radiology medical device. Manufacturer: Dia Imaging Analysis, Ltd.. Cleared Mar 2025. https://www.510kdatabase.net/k243380/ 2025-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k243380-visera-s-video-system-center-olympus-fda-510k.jpg K243380 - VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500) K243380 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Olympus Medical Systems Corporation. Cleared Mar 2025. https://www.510kdatabase.net/k243611/ 2025-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k243611-jlk-sdh-fda-510k.jpg K243611 - JLK-SDH K243611 is a FDA 510(k) cleared radiology medical device. Manufacturer: JLK, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k243881/ 2025-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k243881-heartsee-cardiac-pet-processing-fda-510k.jpg K243881 - HeartSee™ Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4 K243881 is a FDA 510(k) cleared radiology medical device. Manufacturer: Bracco Diagnostics, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k243939/ 2025-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k243939-titanium-flexible-geometry-fsd-fda-510k.jpg K243939 - Titanium Flexible Geometry FSD Applicator Set (GM11013400) K243939 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Mar 2025. https://www.510kdatabase.net/k241041/ 2025-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k241041-silver-fluoride-hypersensitivity-varnish-fda-510k.jpg K241041 - Silver Fluoride Hypersensitivity Varnish K241041 is a FDA 510(k) cleared dental medical device. Manufacturer: Young Dental Manufacturing Co. 1, LLC. Cleared Feb 2025. https://www.510kdatabase.net/k241374/ 2025-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k241374-manual-wheelchair-s002-s004-s005-s006-fda-510k.jpg K241374 - Manual Wheelchair (S002, S004, S005, S006, S007, S008, S009) K241374 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Anhui Jbh Medical Apparatus Co., Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k241617/ 2025-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k241617-durex-polyisoprene-condom-fda-510k.jpg K241617 - Durex Polyisoprene Condom K241617 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Rb Health (Us), LLC. Cleared Feb 2025. https://www.510kdatabase.net/k241717/ 2025-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k241717-e1000-dx-digital-pathology-solution-fda-510k.jpg K241717 - E1000 Dx Digital Pathology Solution K241717 is a FDA 510(k) cleared pathology medical device. Manufacturer: Shandon Diagnostics Limited. Cleared Feb 2025. https://www.510kdatabase.net/k241922/ 2025-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k241922-myomics-fda-510k.jpg K241922 - Myomics K241922 is a FDA 510(k) cleared radiology medical device. Manufacturer: Phantomics, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k242179/ 2025-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k242179-synea-fusion-handpieces-intensiv-profin-fda-510k.jpg K242179 - Synea Fusion Handpieces (Intensiv & Profin) K242179 is a FDA 510(k) cleared dental medical device. Manufacturer: W&H Dentalwerk B?rmoos GmbH. Cleared Feb 2025. https://www.510kdatabase.net/k242339/ 2025-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k242339-intravascular-extension-sets-and-fda-510k.jpg K242339 - Intravascular Extension Sets and Accessories K242339 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corporation. Cleared Feb 2025. https://www.510kdatabase.net/k242676/ 2025-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k242676-preset-delta-thrombectomy-device-and-fda-510k.jpg K242676 - pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device K242676 is a FDA 510(k) cleared neurology medical device. Manufacturer: Phenox Limited. Cleared Feb 2025. https://www.510kdatabase.net/k242718/ 2025-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k242718-portable-oxygen-concentrator-p2-toc-fda-510k.jpg K242718 - Portable Oxygen Concentrator (P2-TOC) K242718 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Qingdao Kingon Medical Science and Technology Co., Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k242798/ 2025-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k242798-airmod-fda-510k.jpg K242798 - Airmod K242798 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Heroic Faith International , Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k242876/ 2025-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k242876-pulse-oximeter-po2-po2a-po2b-fda-510k.jpg K242876 - Pulse Oximeter ( PO2, PO2A, PO2B) K242876 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Viatom Technology Co., Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k243359/ 2025-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k243359-magdi-system-mag-02-ds-01-fda-510k.jpg K243359 - MagDI System (MAG-02, DS-01) K243359 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Gt Metabolic Solutions, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k243436/ 2025-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k243436-seclusion-catheter-fda-510k.jpg K243436 - Seclusion Catheter K243436 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Basis Medical. Cleared Feb 2025. https://www.510kdatabase.net/k243565/ 2025-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k243565-dynamis-si-screw-system-fda-510k.jpg K243565 - DYNAMIS™ SI Screw System K243565 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Promethean Restorative, LLC. Cleared Feb 2025. https://www.510kdatabase.net/k243582/ 2025-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k243582-da-vinci-sp-advanced-access-port-kit-fda-510k.jpg K243582 - da Vinci SP Advanced Access Port Kit (432701) K243582 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k243730/ 2025-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k243730-xpert-c-difficileepi-fda-510k.jpg K243730 - Xpert C. difficile/Epi K243730 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Cepheid. Cleared Feb 2025. https://www.510kdatabase.net/k243874/ 2025-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k243874-fx-coral-60-f00012969-fda-510k.jpg K243874 - FX CorAL 60 (F00012969) K243874 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC. Cleared Feb 2025. https://www.510kdatabase.net/k244039/ 2025-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k244039-medalone-total-knee-system-fda-510k.jpg K244039 - MedalOne Total Knee System K244039 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Suzhou Microport Orthorecon Co., Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k244054/ 2025-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k244054-16ch-flex-speeder-medium-15t-q7000246-fda-510k.jpg K244054 - 16ch Flex SPEEDER Medium 1.5T (Q7000246) K244054 is a FDA 510(k) cleared radiology medical device. Manufacturer: Quality Electrodynamics. Cleared Feb 2025. https://www.510kdatabase.net/k250324/ 2025-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k250324-qiastat-dx-gi-panel-2-mini-b-fda-510k.jpg K250324 - QIAstat-Dx GI Panel 2 Mini B K250324 is a FDA 510(k) cleared microbiology medical device. Manufacturer: QIAGEN GmbH. Cleared Feb 2025. https://www.510kdatabase.net/k241550/ 2025-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k241550-gelweave-vascular-prostheses-fda-510k.jpg K241550 - Gelweave™ Vascular Prostheses K241550 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vascutek, Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k241586/ 2025-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k241586-pivo-pro-needle-free-blood-collection-fda-510k.jpg K241586 - PIVO™ Pro Needle-free Blood Collection Device K241586 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton Dickinson Infusion Therapy Systems, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k241595/ 2025-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k241595-ezvu-visual-vasopressor-injector-ev-19-fda-510k.jpg K241595 - EzVu Visual Vasopressor injector (EV-19) K241595 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Veol Medical Technologies Pvt , Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k241620/ 2025-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k241620-chestview-us-fda-510k.jpg K241620 - ChestView US K241620 is a FDA 510(k) cleared radiology medical device. Manufacturer: Gleamer Sas. Cleared Feb 2025. https://www.510kdatabase.net/k242128/ 2025-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k242128-forsvall-biopsy-needle-system-for-fda-510k.jpg K242128 - Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall biopsy needle) K242128 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Xaga Surgical. Cleared Feb 2025. https://www.510kdatabase.net/k242175/ 2025-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k242175-xod-diathermia-radiofrequency-device-fda-510k.jpg K242175 - XOD Diathermia Radiofrequency Device K242175 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Xod, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k242900/ 2025-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k242900-vader-pedicle-system-and-vaderone-fda-510k.jpg K242900 - VADER® Pedicle System and VADER®one Pedicle System K242900 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Icotec AG. Cleared Feb 2025. https://www.510kdatabase.net/k243357/ 2025-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k243357-castleloc-pectus-bar-system-fda-510k.jpg K243357 - CastleLoc Pectus Bar System K243357 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: L & K Biomed Co., Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k243543/ 2025-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k243543-microinr-system-fda-510k.jpg K243543 - microINR System K243543 is a FDA 510(k) cleared hematology medical device. Manufacturer: Iline Microsystems, S.L.. Cleared Feb 2025. https://www.510kdatabase.net/k243704/ 2025-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k243704-parafleet-sc-014-pta-balloon-fda-510k.jpg K243704 - Parafleet SC 014 PTA Balloon Dilatation Catheter K243704 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Brosmed Medical Co., Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k243738/ 2025-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k243738-the-sensititre-yeastone-susceptibility-fda-510k.jpg K243738 - The Sensititre YeastOne Susceptibility System with Micafungin in the dilution range of 0.008-16 µg/mL K243738 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Thermo Fisher Scientific. Cleared Feb 2025. https://www.510kdatabase.net/k244043/ 2025-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k244043-alltest-multi-drug-rapid-test-cup-fda-510k.jpg K244043 - AllTest Multi-Drug Rapid Test Cup K244043 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Hangzhou AllTest Biotech Co., Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k250021/ 2025-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k250021-rotium-fda-510k.jpg K250021 - Rotium K250021 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nanofiber Solutions, LLC. Cleared Feb 2025. https://www.510kdatabase.net/k241222/ 2025-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k241222-ventripoint-medical-system-plus-vms-40-fda-510k.jpg K241222 - Ventripoint Medical System Plus (VMS+) 4.0 K241222 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ventripoint Diagnostics , Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k241546/ 2025-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k241546-aicockpit-ai-viewer-fda-510k.jpg K241546 - aiCockpit AI Viewer K241546 is a FDA 510(k) cleared radiology medical device. Manufacturer: Fovia, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k241576/ 2025-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k241576-makoto-intravascular-imaging-system-vc-fda-510k.jpg K241576 - Makoto Intravascular Imaging System™ (VC-MC10 / TVC-MC10i) K241576 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Infraredx, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k241587/ 2025-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k241587-pilot-tls-fda-510k.jpg K241587 - pilot TLS K241587 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vygon Corporation. Cleared Feb 2025. https://www.510kdatabase.net/k242844/ 2025-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k242844-medline-level-4-surgical-gown-with-fda-510k.jpg K242844 - Medline Level 4 Surgical Gown with Breathable Sleeves K242844 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, LP. Cleared Feb 2025. https://www.510kdatabase.net/k243918/ 2025-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k243918-vasoview-hemopro-3-power-supply-fda-510k.jpg K243918 - Vasoview Hemopro 3 Power Supply K243918 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Maquet Cardiovascular, LLC. Cleared Feb 2025. https://www.510kdatabase.net/k244031/ 2025-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k244031-disposable-blood-lancet-soft-pro-fda-510k.jpg K244031 - Disposable Blood Lancet (Soft Pro) K244031 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: SteriLance Medical (Suzhou), Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k244036/ 2025-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k244036-heel-incision-safety-lancet-steriheel-2-fda-510k.jpg K244036 - Heel Incision Safety Lancet (SteriHeel 2) K244036 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: SteriLance Medical (Suzhou), Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k250012/ 2025-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k250012-millipede-070-aspiration-catheter-fda-510k.jpg K250012 - Millipede 070 Aspiration Catheter K250012 is a FDA 510(k) cleared neurology medical device. Manufacturer: Perfuze, Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k250202/ 2025-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k250202-aventus-thrombectomy-system-fda-510k.jpg K250202 - Aventus Thrombectomy System K250202 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inquis Medical. Cleared Feb 2025. https://www.510kdatabase.net/k250281/ 2025-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k250281-deka-lotus-fda-510k.jpg K250281 - DEKA LOTUS K250281 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: El.En S.P.A.. Cleared Feb 2025. https://www.510kdatabase.net/k250346/ 2025-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k250346-bonvie-fda-510k.jpg K250346 - BonVie+ K250346 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Elute, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k233963/ 2025-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k233963-aulisa-oximeter-module-2nd-gen-ga-fda-510k.jpg K233963 - Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008) K233963 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Taiwan Aulisa Medical Devices Technologies, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k241601/ 2025-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k241601-ems-flexpulse-magnacore-magnetika-fda-510k.jpg K241601 - EMS (FlexPulse, MagnaCore, Magnetika) K241601 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Cpmt Laser (Canadian Pioneer Medical Technology Corporation). Cleared Feb 2025. https://www.510kdatabase.net/k242822/ 2025-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k242822-art-plan-v300-fda-510k.jpg K242822 - ART-Plan+ (v.3.0.0) K242822 is a FDA 510(k) cleared radiology medical device. Manufacturer: Therapanacea Sas. Cleared Feb 2025. https://www.510kdatabase.net/k242967/ 2025-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k242967-loss-of-pulse-detection-fda-510k.jpg K242967 - Loss of Pulse Detection K242967 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Fitbit. Cleared Feb 2025. https://www.510kdatabase.net/k243276/ 2025-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k243276-echelon-linear-stapler-30mm-stapler-fda-510k.jpg K243276 - ECHELON LINEAR™ Stapler 30mm Stapler (GTX30) K243276 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon Endo-Surgery, LLC. Cleared Feb 2025. https://www.510kdatabase.net/k243446/ 2025-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k243446-3dxr-fda-510k.jpg K243446 - 3DXR K243446 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems SCS. Cleared Feb 2025. https://www.510kdatabase.net/k250223/ 2025-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k250223-bruxzir-esthetic-now-fda-510k.jpg K250223 - BruxZir® Esthetic NOW K250223 is a FDA 510(k) cleared dental medical device. Manufacturer: Prismatik Dentalcraft, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k250238/ 2025-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k250238-washercap-fixation-system-fda-510k.jpg K250238 - WasherCap™ Fixation System K250238 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Abanza Tecnomed S.L. Cleared Feb 2025. https://www.510kdatabase.net/k250348/ 2025-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k250348-jlk-ailink-fda-510k.jpg K250348 - JLK-AILink K250348 is a FDA 510(k) cleared radiology medical device. Manufacturer: JLK, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k241565/ 2025-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k241565-sterilization-packagereel-fda-510k.jpg K241565 - Sterilization Package/Reel K241565 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Anqing Clean Dental Instrument Technology Co., Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k241703/ 2025-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k241703-sd-implant-system-fda-510k.jpg K241703 - SD Implant System K241703 is a FDA 510(k) cleared dental medical device. Manufacturer: Arum Dentistry Co., Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k242994/ 2025-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k242994-oncostudio-os-01-fda-510k.jpg K242994 - OncoStudio (OS-01) K242994 is a FDA 510(k) cleared radiology medical device. Manufacturer: Oncosoft. Co., Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k243035/ 2025-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k243035-ulthera-system-fda-510k.jpg K243035 - Ulthera® System K243035 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ulthera, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k243287/ 2025-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k243287-apro-70-swift-catheter-and-alembic-fda-510k.jpg K243287 - APRO 70 Swift Catheter and Alembic Aspiration Tubing K243287 is a FDA 510(k) cleared neurology medical device. Manufacturer: Alembic, LLC. Cleared Feb 2025. https://www.510kdatabase.net/k243823/ 2025-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k243823-control-iq-technology-fda-510k.jpg K243823 - Control-IQ+ technology K243823 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Tandem Diabetes Care, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k243959/ 2025-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k243959-powder-free-nitrile-examination-gloves-fda-510k.jpg K243959 - Powder Free Nitrile Examination Gloves (Violet, Black, Green), Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Select Other Drugs K243959 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Lingshi Hongruida Health Protection Technology Co., Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k244010/ 2025-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k244010-examvue-apex-fda-510k.jpg K244010 - ExamVue Apex K244010 is a FDA 510(k) cleared radiology medical device. Manufacturer: Jpi Healthcare Co, Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k241186/ 2025-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k241186-synthetic-bone-graft-particulate-fda-510k.jpg K241186 - Synthetic Bone Graft Particulate K241186 is a FDA 510(k) cleared dental medical device. Manufacturer: Shenzhen Dazhou Medical Technology Co., Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k241555/ 2025-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k241555-moldable-bone-void-filler-and-moldable-fda-510k.jpg K241555 - Moldable Bone Void Filler and Moldable Bone Void Filler + CCC K241555 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Rti Surgical, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k241563/ 2025-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k241563-extremity-medical-external-fixation-fda-510k.jpg K241563 - Extremity Medical External Fixation System K241563 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Extremity Medical, LLC. Cleared Feb 2025. https://www.510kdatabase.net/k241983/ 2025-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k241983-fassier-duval-telescoping-im-system-fda-510k.jpg K241983 - Fassier-Duval Telescoping IM System K241983 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthopediatrics Canada Ulc Dba Pega Medical. Cleared Feb 2025. https://www.510kdatabase.net/k242607/ 2025-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k242607-scandiags-ortho-l-spine-mr-q-fda-510k.jpg K242607 - ScanDiags Ortho L-Spine MR-Q K242607 is a FDA 510(k) cleared radiology medical device. Manufacturer: Scandiags AG. Cleared Feb 2025. https://www.510kdatabase.net/k242838/ 2025-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k242838-quickrad-fda-510k.jpg K242838 - QuickRad K242838 is a FDA 510(k) cleared radiology medical device. Manufacturer: Aikenist Technologies Pvt, Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k242850/ 2025-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k242850-wearable-breast-pump-model-w8-fda-510k.jpg K242850 - Wearable breast pump (model W8) K242850 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shenzhen TPH Technology Co., Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k242898/ 2025-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k242898-sterilization-pouches-and-reels-fda-510k.jpg K242898 - Sterilization Pouches and Reels K242898 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shanghai Jianzhong Medical Packaging Co., Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k243088/ 2025-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k243088-green-x-12-se-pht-40chs-fda-510k.jpg K243088 - Green X 12 SE (PHT-40CHS) K243088 is a FDA 510(k) cleared radiology medical device. Manufacturer: VATECH Co., Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k243115/ 2025-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k243115-upper-arm-electronic-blood-pressure-fda-510k.jpg K243115 - Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) and U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z)) K243115 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Urion Technology Co., Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k243258/ 2025-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k243258-paradigm-system-fda-510k.jpg K243258 - Paradigm System K243258 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Proprio, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k243278/ 2025-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k243278-custom-abutments-fda-510k.jpg K243278 - Custom Abutments K243278 is a FDA 510(k) cleared dental medical device. Manufacturer: Institut Straumann AG. Cleared Feb 2025. https://www.510kdatabase.net/k243330/ 2025-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k243330-lyma-laser-pro-fda-510k.jpg K243330 - LYMA Laser PRO K243330 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lyma Life , Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k243431/ 2025-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k243431-medicom-sterilization-pouch-and-reel-fda-510k.jpg K243431 - Medicom Sterilization Pouch and Reel K243431 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medicom Asia-Pacific Holdings Ltd. Taiwan Branch.. Cleared Feb 2025. https://www.510kdatabase.net/k243614/ 2025-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k243614-sonio-suspect-fda-510k.jpg K243614 - Sonio Suspect K243614 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sonio. Cleared Feb 2025. https://www.510kdatabase.net/k243637/ 2025-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k243637-materialise-personalized-guides-and-fda-510k.jpg K243637 - Materialise Personalized Guides and Models for Craniomaxillofacial Surgery K243637 is a FDA 510(k) cleared dental medical device. Manufacturer: Materialise NV. Cleared Feb 2025. https://www.510kdatabase.net/k243640/ 2025-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k243640-trojan-ultra-ribbed-ecstasy-latex-fda-510k.jpg K243640 - Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed Ecstasy) K243640 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Church & Dwight Co., Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k243916/ 2025-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k243916-primus-spinal-fixation-system-fda-510k.jpg K243916 - Primus Spinal Fixation System K243916 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinal Elements, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k243940/ 2025-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k243940-vita-yz-multi-translucent-fda-510k.jpg K243940 - VITA YZ Multi Translucent K243940 is a FDA 510(k) cleared dental medical device. Manufacturer: Vita Zahnfabrik H.Rauter GmbH & Co.. Cleared Feb 2025. https://www.510kdatabase.net/k243951/ 2025-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k243951-temp-master-pmma-based-dental-resin-fda-510k.jpg K243951 - TEMP MASTER, PMMA-based dental resin K243951 is a FDA 510(k) cleared dental medical device. Manufacturer: Taiwan Dental Materials Co., Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k250027/ 2025-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k250027-powered-mobility-scooter-fda-510k.jpg K250027 - Powered Mobility Scooter K250027 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Intradin (Shanghai) Machinery Co., Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k250218/ 2025-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k250218-xpert-fii-fv-fda-510k.jpg K250218 - Xpert® FII & FV K250218 is a FDA 510(k) cleared hematology medical device. Manufacturer: Cepheid. Cleared Feb 2025. https://www.510kdatabase.net/k234004/ 2025-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k234004-medical-diode-laser-systems-charisma-fda-510k.jpg K234004 - Medical diode laser systems (CHARISMA, REGAL) K234004 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Reveal Lasers , Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k241470/ 2025-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k241470-core-shoulder-system-fda-510k.jpg K241470 - CORE Shoulder System K241470 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: LinkBio Corp.. Cleared Feb 2025. https://www.510kdatabase.net/k241626/ 2025-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k241626-spersort-sperm-sorting-chip-ipg02-fda-510k.jpg K241626 - SperSort™ Sperm Sorting Chip (IPG02) K241626 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ipreg Incorporation. Cleared Feb 2025. https://www.510kdatabase.net/k242240/ 2025-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k242240-cari-plaque-fda-510k.jpg K242240 - CaRi-Plaque K242240 is a FDA 510(k) cleared radiology medical device. Manufacturer: Caristo Diagnostics , Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k242447/ 2025-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k242447-falcon-hst-fda-510k.jpg K242447 - Falcon HST K242447 is a FDA 510(k) cleared neurology medical device. Manufacturer: Compumedics Limited. Cleared Feb 2025. https://www.510kdatabase.net/k242681/ 2025-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k242681-nusono-handheld-ultrasound-scanner-fda-510k.jpg K242681 - NUSONO Handheld Ultrasound Scanner (NUSONO-C35) K242681 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nurodata, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k242821/ 2025-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k242821-efai-chestsuite-xr-malpositioned-ett-fda-510k.jpg K242821 - EFAI Chestsuite XR Malpositioned ETT Assessment System (ETT-XR-100) K242821 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ever Fortune.Ai, Co., Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k243086/ 2025-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k243086-unimed-reusable-finger-clip-spo2-fda-510k.jpg K243086 - Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91) K243086 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Unimed Medical Supplies, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k243283/ 2025-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k243283-alinity-h-series-system-fda-510k.jpg K243283 - Alinity h-series System K243283 is a FDA 510(k) cleared hematology medical device. Manufacturer: Abbott Laboratories. Cleared Feb 2025. https://www.510kdatabase.net/k243312/ 2025-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k243312-cer-s-fda-510k.jpg K243312 - CER-S K243312 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cardiocalm Srl. Cleared Feb 2025. https://www.510kdatabase.net/k243344/ 2025-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k243344-arthrex-fibertape-and-tigertape-fda-510k.jpg K243344 - Arthrex FiberTape and TigerTape Cerclage Sutures K243344 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k250067/ 2025-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k250067-dochek-multi-drug-urine-test-cup-fda-510k.jpg K250067 - Dochek® Multi-Drug Urine Test Cup K250067 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Guangzhou Decheng Biotechnology Co., Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k250140/ 2025-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k250140-defendo-fujifilm-700-single-use-fda-510k.jpg K250140 - Defendo Fujifilm 700 Single Use Cleaning Adapter K250140 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Steris Corparation. Cleared Feb 2025. https://www.510kdatabase.net/k250172/ 2025-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k250172-green-card-bowie-dick-test-bd115-fda-510k.jpg K250172 - Green Card Bowie-Dick Test (BD115) K250172 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Steritec Products, Inc. (A Getinge Company). Cleared Feb 2025. https://www.510kdatabase.net/k250214/ 2025-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k250214-acclarix-ax8-series-diagnostic-fda-510k.jpg K250214 - Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8, Acclarix AX75, Acclarix AX78, Acclarix AX8 Exp, Acclarix AX8 Super), Acclarix AX9 Series Diagnostic Ultrasound Szystem (Model: Acclarix AX9 Basic, Acclarix AX9, Acclarix AX9 Exp, Acclarix AX9 Super, Acclarix AX85, Acclarix AX88) K250214 is a FDA 510(k) cleared radiology medical device. Manufacturer: Edan Instruments, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k250487/ 2025-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k250487-sparktm-clear-aligner-system-fda-510k.jpg K250487 - SparkTM Clear Aligner System K250487 is a FDA 510(k) cleared dental medical device. Manufacturer: Ormco Corporation. Cleared Feb 2025. https://www.510kdatabase.net/k241578/ 2025-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k241578-wrist-digital-blood-pressure-monitor-fda-510k.jpg K241578 - Wrist Digital Blood Pressure Monitor (BSX312, BSX313, BSX315, BSX322, BSX323, BSX353, BSX355) K241578 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Bsx Technology Electronics Co., Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k241666/ 2025-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k241666-evos-pelvic-and-acetabular-system-fda-510k.jpg K241666 - EVOS Pelvic and Acetabular System K241666 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew. Cleared Feb 2025. https://www.510kdatabase.net/k242023/ 2025-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k242023-microdent-sterilization-cassette-fda-510k.jpg K242023 - Microdent Sterilization Cassette K242023 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Implant Microdent System S.L.U.. Cleared Feb 2025. https://www.510kdatabase.net/k242411/ 2025-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k242411-brainomix-360-e-lung-fda-510k.jpg K242411 - Brainomix 360 e-Lung K242411 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainomix Limited. Cleared Feb 2025. https://www.510kdatabase.net/k242455/ 2025-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k242455-avita-pulse-oximeter-sp62b-fda-510k.jpg K242455 - AViTA Pulse Oximeter (SP62B) K242455 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Avita Corporation. Cleared Feb 2025. https://www.510kdatabase.net/k242526/ 2025-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k242526-visby-medical-respiratory-health-test-fda-510k.jpg K242526 - Visby Medical Respiratory Health Test K242526 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Visby Medical, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k243206/ 2025-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k243206-air-compression-massager-acm-plus-a1-fda-510k.jpg K243206 - Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4, ACM-PLUS-A5, ACM-PLUS-A6) K243206 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Sichuan Qianli-Beoka Medical Technology, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k243241/ 2025-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k243241-phasix-st-umbilical-hernia-patch-fda-510k.jpg K243241 - Phasix ST Umbilical Hernia Patch K243241 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Davol, Inc., A Subsidiary of C.R. Bard, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k243478/ 2025-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k243478-straumann-inlab-validated-workflow-fda-510k.jpg K243478 - Straumann InLab Validated Workflow K243478 is a FDA 510(k) cleared dental medical device. Manufacturer: Institut Straumann AG. Cleared Feb 2025. https://www.510kdatabase.net/k243588/ 2025-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k243588-single-use-co2-laser-fiber-haf005001-fda-510k.jpg K243588 - Single Use CO2 Laser Fiber (HAF005001) K243588 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Quanta System Spa. Cleared Feb 2025. https://www.510kdatabase.net/k243591/ 2025-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k243591-optovision-endoscopic-light-source-unit-fda-510k.jpg K243591 - OPTOVISION Endoscopic Light Source Unit K243591 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Optosurgical, LLC. Cleared Feb 2025. https://www.510kdatabase.net/k243761/ 2025-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k243761-alps-small-fragment-plating-system-fda-510k.jpg K243761 - A.L.P.S. Small Fragment Plating System K243761 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet Orthopedics. Cleared Feb 2025. https://www.510kdatabase.net/k244015/ 2025-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k244015-superball-rc-fda-510k.jpg K244015 - SuperBall-RC™ K244015 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arcuro Medical , Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k250473/ 2025-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k250473-dental-delivery-system-series-5-and-fda-510k.jpg K250473 - Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus K250473 is a FDA 510(k) cleared dental medical device. Manufacturer: Dci International, LLC. Cleared Feb 2025. https://www.510kdatabase.net/k243574/ 2025-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k243574-evolution-total-knee-systems-kinematic-fda-510k.jpg K243574 - Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique K243574 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Microport Orthopedics, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k243576/ 2025-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k243576-renasys-foam-wound-dressing-kit-with-fda-510k.jpg K243576 - RENASYS Foam Wound Dressing Kit with AIRLOCK Technology and Soft Port K243576 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew Medical, Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k243584/ 2025-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k243584-004-zero-zero-four-male-latex-condom-fda-510k.jpg K243584 - 0.04 ZERO ZERO FOUR Male Latex Condom K243584 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Okamoto USA, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k243593/ 2025-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k243593-axs-lift-intracranial-base-catheter-fda-510k.jpg K243593 - AXS Lift Intracranial Base Catheter K243593 is a FDA 510(k) cleared neurology medical device. Manufacturer: Stryker Neurovascular. Cleared Feb 2025. https://www.510kdatabase.net/k243792/ 2025-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k243792-nitrile-powder-free-exam-gloves-tested-fda-510k.jpg K243792 - Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate (Black,White) K243792 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Basic Medical Technology, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k243915/ 2025-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k243915-fix-c-3d-ti-acif-system-fda-510k.jpg K243915 - FIX-C 3D Ti ACIF System K243915 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Jeil Medical Corporation. Cleared Feb 2025. https://www.510kdatabase.net/k241737/ 2025-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k241737-sway-system-sports-plus-fda-510k.jpg K241737 - Sway System Sports Plus K241737 is a FDA 510(k) cleared neurology medical device. Manufacturer: Sway Medical, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k241527/ 2025-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k241527-pastelle-pro-fda-510k.jpg K241527 - Pastelle Pro K241527 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wontech Co., Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k241573/ 2025-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k241573-alinity-m-resp-4-plex-fda-510k.jpg K241573 - Alinity m Resp-4-Plex K241573 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Molecular, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k241643/ 2025-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k241643-wontech-surgical-optic-fibers-fda-510k.jpg K241643 - WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R) K241643 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wontech Co., Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k241958/ 2025-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k241958-ward-css-v12x-fda-510k.jpg K241958 - WARD-CSS (v1.2.x) K241958 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ward 24/7 Aps. Cleared Feb 2025. https://www.510kdatabase.net/k242198/ 2025-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k242198-ics-dizcovery-1091-fda-510k.jpg K242198 - ICS Dizcovery (1091) K242198 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Natus Medical Denmark Aps. Cleared Feb 2025. https://www.510kdatabase.net/k242593/ 2025-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k242593-currentbody-led-4-in-1-zone-facial-fda-510k.jpg K242593 - CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N) K242593 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Kaiyan Medical Equipment Co., Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k242776/ 2025-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k242776-limflow-v-ceiver-fda-510k.jpg K242776 - LimFlow V-Ceiver K242776 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: LimFlow, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k243081/ 2025-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k243081-green-x-21-pht-90cho-fda-510k.jpg K243081 - Green X 21 (PHT-90CHO) K243081 is a FDA 510(k) cleared radiology medical device. Manufacturer: VATECH Co., Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k243136/ 2025-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k243136-non-contact-forehead-infrared-fda-510k.jpg K243136 - Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209) K243136 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen Finicare Co., Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k243212/ 2025-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k243212-dess-dental-smart-solutions-fda-510k.jpg K243212 - DESS Dental Smart Solutions K243212 is a FDA 510(k) cleared dental medical device. Manufacturer: Terrats Medical SL. Cleared Feb 2025. https://www.510kdatabase.net/k243294/ 2025-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k243294-brainomix-360-e-aspects-fda-510k.jpg K243294 - Brainomix 360 e-ASPECTS K243294 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainomix Limited. Cleared Feb 2025. https://www.510kdatabase.net/k243503/ 2025-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k243503-via360-surgical-system-fda-510k.jpg K243503 - VIA360™ Surgical System K243503 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: New World Medical, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k243696/ 2025-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k243696-aview-cac-fda-510k.jpg K243696 - AVIEW CAC K243696 is a FDA 510(k) cleared radiology medical device. Manufacturer: Coreline Soft Co., Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k250248/ 2025-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k250248-briefcase-triage-fda-510k.jpg K250248 - BriefCase-Triage K250248 is a FDA 510(k) cleared radiology medical device. Manufacturer: Aidoc Medical , Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k241410/ 2025-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k241410-eden-controlcath-fda-510k.jpg K241410 - EDEN ControlCath K241410 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Jmt Co., Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k241597/ 2025-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k241597-freedom-total-knee-system-porous-fda-510k.jpg K241597 - Freedom® Total Knee System - Porous Tibial Base Plate K241597 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Maxx Orthopedics, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k241832/ 2025-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k241832-unicorn-rf-system-unicorn-fda-510k.jpg K241832 - Unicorn+ RF System (Unicorn+) K241832 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Boston Aesthetics, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k242104/ 2025-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k242104-penumbra-system-reperfusion-catheter-fda-510k.jpg K242104 - Penumbra System (Reperfusion Catheter RED 72) K242104 is a FDA 510(k) cleared neurology medical device. Manufacturer: Penumbra, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k242317/ 2025-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k242317-integrated-endo-system-meet-endo-ii-fda-510k.jpg K242317 - Integrated Endo System (Meet Endo-II) K242317 is a FDA 510(k) cleared dental medical device. Manufacturer: Denjoy Dental Co., Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k243319/ 2025-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k243319-ampa-one-system-ampa-001-fda-510k.jpg K243319 - Ampa One System (AMPA-001) K243319 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neuromodulatory Devices & Applications. Cleared Feb 2025. https://www.510kdatabase.net/k243396/ 2025-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k243396-aptima-sars-cov-2-assay-fda-510k.jpg K243396 - Aptima SARS-CoV-2 Assay K243396 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Hologic, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k243546/ 2025-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k243546-ah-plus-endodontic-sealer-fda-510k.jpg K243546 - AH Plus Endodontic Sealer K243546 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k243778/ 2025-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k243778-body-temperature-software-bts-fda-510k.jpg K243778 - Body Temperature Software (BTS) K243778 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Fitbit, LLC. Cleared Feb 2025. https://www.510kdatabase.net/k243912/ 2025-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k243912-newclip-patient-matched-fda-510k.jpg K243912 - Newclip Patient-matched instrumentation non sterile PSI K243912 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Newclip Technics. Cleared Feb 2025. https://www.510kdatabase.net/k250117/ 2025-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k250117-fastep-pregnancy-rapid-test-cassette-fda-510k.jpg K250117 - FaStep Pregnancy Rapid Test Cassette K250117 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Assure Tech., LLC. Cleared Feb 2025. https://www.510kdatabase.net/k241418/ 2025-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k241418-optomonitor-3-fda-510k.jpg K241418 - OptoMonitor 3 K241418 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Opsens, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k241425/ 2025-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k241425-aspenview-fda-510k.jpg K241425 - AspenView K241425 is a FDA 510(k) cleared radiology medical device. Manufacturer: Aspen Imaging Healthcare, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k241479/ 2025-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k241479-etiometry-platform-dav-54-rae-92-fda-510k.jpg K241479 - Etiometry Platform (DAV 5.4 RAE 9.2) K241479 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Etiometry, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k242006/ 2025-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k242006-surewave-elastography-q7000225-fda-510k.jpg K242006 - SureWave Elastography (Q7000225) K242006 is a FDA 510(k) cleared radiology medical device. Manufacturer: Quality Electrodynamics, LLC. Cleared Feb 2025. https://www.510kdatabase.net/k242666/ 2025-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k242666-fecobionics-anorectal-system-fda-510k.jpg K242666 - Fecobionics Anorectal System K242666 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Gi Bionics, LLC. Cleared Feb 2025. https://www.510kdatabase.net/k243250/ 2025-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k243250-subtlehd-1x-fda-510k.jpg K243250 - SubtleHD (1.x) K243250 is a FDA 510(k) cleared radiology medical device. Manufacturer: Subtle Medical, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k243523/ 2025-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k243523-naeotom-alphapeak-naeotom-alpha-fda-510k.jpg K243523 - NAEOTOM Alpha.Peak/ NAEOTOM Alpha K243523 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k243575/ 2025-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k243575-architect-hsv-2-igg-architect-hsv-2-fda-510k.jpg K243575 - ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls K243575 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Biokit, S.A.. Cleared Feb 2025. https://www.510kdatabase.net/k243702/ 2025-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k243702-v8-diagnostic-ultrasound-system-fda-510k.jpg K243702 - V8 Diagnostic Ultrasound System K243702 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Medison Co., Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k243907/ 2025-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k243907-affixus-tibial-nailing-system-4mm-screws-fda-510k.jpg K243907 - Affixus Tibial Nailing System - 4mm screws K243907 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k243961/ 2025-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k243961-electrically-powered-wheelchair-fda-510k.jpg K243961 - Electrically Powered Wheelchair K243961 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Kunshan Hi-Fortune Health Products Co., Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k243962/ 2025-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k243962-electrically-powered-wheelchair-fda-510k.jpg K243962 - Electrically Powered Wheelchair K243962 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Kunshan Hi-Fortune Health Products Co., Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k240867/ 2025-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k240867-cobas-sars-cov-2-qualitative-for-use-fda-510k.jpg K240867 - cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems K240867 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Molecular Systems, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k241451/ 2025-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k241451-rusch-endotracheal-tubes-reinforced-fda-510k.jpg K241451 - Rusch Endotracheal Tubes (Reinforced) K241451 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Teleflex Incorporated. Cleared Feb 2025. https://www.510kdatabase.net/k241462/ 2025-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k241462-longy-implant-and-longy-n-implant-fda-510k.jpg K241462 - LONGY Implant and LONGY-N Implant K241462 is a FDA 510(k) cleared dental medical device. Manufacturer: Noris Medical , Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k241634/ 2025-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k241634-wrist-blood-pressure-monitor-xy-w01a-fda-510k.jpg K241634 - Wrist Blood Pressure Monitor (XY-W01A, XY-W01B) K241634 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Guangdong Xinyu Electronic and Technology Co., Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k241817/ 2025-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k241817-inset-total-shoulder-system-fda-510k.jpg K241817 - InSet Total Shoulder System K241817 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Shoulder Innovations, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k241897/ 2025-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k241897-mor-fda-510k.jpg K241897 - MOR K241897 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Morari, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k243155/ 2025-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k243155-single-use-digital-flexible-fda-510k.jpg K243155 - Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) K243155 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Dongguan Zsr Biomedical Technology Company Limited. Cleared Feb 2025. https://www.510kdatabase.net/k243188/ 2025-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k243188-cylox-st-fda-510k.jpg K243188 - CYLOX® ST K243188 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Signus Medizintechnik GmbH. Cleared Feb 2025. https://www.510kdatabase.net/k243317/ 2025-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k243317-nuventus-nvc-surgical-cassette-and-tray-fda-510k.jpg K243317 - NUVENTUS NV.C™ Surgical Cassette and Tray K243317 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Infinitum Eta, Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k243518/ 2025-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k243518-binaxnow-covid-19-antigen-self-test-fda-510k.jpg K243518 - BinaxNOW™ COVID-19 Antigen Self Test K243518 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Diagnostics Scarborough, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k243620/ 2025-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k243620-vivid-iq-fda-510k.jpg K243620 - Vivid iq K243620 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared Feb 2025. https://www.510kdatabase.net/k243628/ 2025-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k243628-vivid-t9vivid-t8-fda-510k.jpg K243628 - Vivid T9/Vivid T8 K243628 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared Feb 2025. https://www.510kdatabase.net/k250200/ 2025-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k250200-inbellabody-system-fda-510k.jpg K250200 - InbellaBody System K250200 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Inbella Medical, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k240958/ 2025-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k240958-locking-plates-and-screws-systems-fda-510k.jpg K240958 - Locking Plates and Screws Systems K240958 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Hebei Ruihe Medical Devices Co., Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k241516/ 2025-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k241516-btl-398-fda-510k.jpg K241516 - BTL-398 K241516 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: BTL Industries, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k241659/ 2025-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k241659-ultrasound-workspace-uws-60-fda-510k.jpg K241659 - Ultrasound Workspace (UWS 6.0) K241659 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Ultrasound, LLC. Cleared Feb 2025. https://www.510kdatabase.net/k242905/ 2025-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k242905-the-sensititre-20-24-hour-haemophilus-fda-510k.jpg K242905 - The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.12-32 ug/mL K242905 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Thermo Fisher Scientific. Cleared Feb 2025. https://www.510kdatabase.net/k243063/ 2025-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k243063-myolight-microcurrent-handpiece-fda-510k.jpg K243063 - Myolight Microcurrent Handpiece K243063 is a FDA 510(k) cleared neurology medical device. Manufacturer: Raja Trading Company, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k243201/ 2025-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k243201-the-sensititre-20-24-hour-haemophilus-fda-510k.jpg K243201 - The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with penicillin in the dilution range of 0.015-32 ug/mL K243201 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Thermo Fisher Scientific. Cleared Feb 2025. https://www.510kdatabase.net/k243453/ 2025-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k243453-philips-lumea-ipl-fda-510k.jpg K243453 - Philips Lumea IPL K243453 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Philips Consumer Lifestyle B.V.. Cleared Feb 2025. https://www.510kdatabase.net/k243511/ 2025-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k243511-otc-tens-ems-unit-fda-510k.jpg K243511 - OTC TENS & EMS Unit K243511 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Changsha Anxiang Medical Technology Co., Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k243516/ 2025-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k243516-remi-custom-night-guard-fda-510k.jpg K243516 - Remi Custom Night Guard K243516 is a FDA 510(k) cleared dental medical device. Manufacturer: Grindguard, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k244042/ 2025-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k244042-calcium2-fda-510k.jpg K244042 - Calcium2 K244042 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Ireland. Cleared Feb 2025. https://www.510kdatabase.net/k241453/ 2025-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k241453-elecsys-sflt-1-and-elecsys-plgf-fda-510k.jpg K241453 - Elecsys sFlt-1 and Elecsys PlGF K241453 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Feb 2025. https://www.510kdatabase.net/k241483/ 2025-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k241483-ceramys-femoral-head-system-fda-510k.jpg K241483 - ceramys™ femoral head system K241483 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Encore Medical, L.P.. Cleared Feb 2025. https://www.510kdatabase.net/k242368/ 2025-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k242368-symani-surgical-system-fda-510k.jpg K242368 - Symani Surgical System K242368 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medical Microinstruments, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k242404/ 2025-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k242404-bdc-dental-unit-fda-510k.jpg K242404 - BDC Dental Unit K242404 is a FDA 510(k) cleared dental medical device. Manufacturer: Bdc Dental Corporation , Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k242483/ 2025-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k242483-genesys-spine-ais-c-ii-cervical-fda-510k.jpg K242483 - Genesys Spine AIS-C II Cervical Interbody Fusion System K242483 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Genesys Spine. Cleared Feb 2025. https://www.510kdatabase.net/k242713/ 2025-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k242713-any-com-bulk-fda-510k.jpg K242713 - Any-Com Bulk K242713 is a FDA 510(k) cleared dental medical device. Manufacturer: Mediclus Co., Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k242957/ 2025-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k242957-identify-40-fda-510k.jpg K242957 - Identify (4.0) K242957 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k243321/ 2025-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k243321-endoscopic-video-image-processor-rp-fda-510k.jpg K243321 - Endoscopic Video Image Processor (RP-IPD-V1000F) K243321 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Guangzhou Red Pine Medical Instrument Co., Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k243661/ 2025-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k243661-electronic-blood-pressure-monitor-fda-510k.jpg K243661 - Electronic Blood Pressure Monitor K243661 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hetaida Technology Co., Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k243780/ 2025-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k243780-helios-785-pico-1754v2-fda-510k.jpg K243780 - HELIOS 785 Pico (1754V2) K243780 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Laseroptek Co., Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k243996/ 2025-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k243996-assuretech-panel-dip-tests-fda-510k.jpg K243996 - AssureTech Panel Dip Tests K243996 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Assure Tech., LLC. Cleared Feb 2025. https://www.510kdatabase.net/k241599/ 2025-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k241599-signature-osteosynthesis-plate-system-fda-510k.jpg K241599 - Signature Osteosynthesis Plate System K241599 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Signature Orthopaedic Pty , Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k241702/ 2025-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k241702-crosslead-0014inch-fda-510k.jpg K241702 - CROSSLEAD 0.014inch K241702 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Asahi Intecc Co., Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k242111/ 2025-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k242111-vivace-fda-510k.jpg K242111 - VIVACE K242111 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Unimom.Co. Cleared Feb 2025. https://www.510kdatabase.net/k242192/ 2025-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k242192-disposable-sphincterotome-fda-510k.jpg K242192 - Disposable Sphincterotome K242192 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Beijing Zksk Technology Co., Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k242324/ 2025-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k242324-dutau-novatech-fda-510k.jpg K242324 - DUTAU-NOVATECH® K242324 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Novatech SA. Cleared Feb 2025. https://www.510kdatabase.net/k242428/ 2025-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k242428-dochek-fentanyl-urine-test-strip-fda-510k.jpg K242428 - Dochek® Fentanyl Urine Test Strip, Dochek® Fentanyl Urine Test Strip Plus, Dochek® Fentanyl Urine Test Card, Dochek® Fentanyl Urine Test Card Plus, Dochek® Fentanyl Urine Test Cup and Dochek® Fentanyl Urine Test Cup Plus K242428 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Guangzhou Decheng Biotechnology Co., Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k242580/ 2025-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k242580-unimed-reusable-finger-clip-spo2-fda-510k.jpg K242580 - Unimed Reusable Finger Clip SpO2 Sensors (U103-125) K242580 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Unimed Medical Supplies, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k242977/ 2025-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k242977-308nm-excimer-phototherapy-device-cn-fda-510k.jpg K242977 - 308nm Excimer Phototherapy Device (CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K) K242977 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Xuzhou Kernel Medical Equipment Co., Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k243243/ 2025-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k243243-delphi-mcs-electrode-cap-fda-510k.jpg K243243 - Delphi MCS Electrode Cap K243243 is a FDA 510(k) cleared neurology medical device. Manufacturer: Quantalx Neuroscience, Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k243465/ 2025-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k243465-diode-laser-hair-removal-device-fda-510k.jpg K243465 - Diode Laser Hair Removal Device (EVOLUTION MEDICAL) K243465 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Guangzhou Chuang Zao Mei Technology Co., Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k243488/ 2025-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k243488-vmat-pro-fda-510k.jpg K243488 - VMAT PRO K243488 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Termosalud. Cleared Feb 2025. https://www.510kdatabase.net/k243784/ 2025-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k243784-stryker-orthopaedics-hip-devices-fda-510k.jpg K243784 - Stryker Orthopaedics Hip Devices Labeling Update K243784 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp., Dba Stryker Orthopaedics. Cleared Feb 2025. https://www.510kdatabase.net/k243794/ 2025-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k243794-epiq-series-diagnostic-ultrasound-system-fda-510k.jpg K243794 - EPIQ Series Diagnostic Ultrasound System K243794 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Ultrasound, LLC. Cleared Feb 2025. https://www.510kdatabase.net/k243817/ 2025-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k243817-scorpio-universal-dome-patella-fda-510k.jpg K243817 - Scorpio Universal Dome Patella K243817 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp., Dba Stryker Orthopaedics. Cleared Feb 2025. https://www.510kdatabase.net/k244034/ 2025-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k244034-disposable-powder-free-nitrile-fda-510k.jpg K244034 - Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine K244034 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ever Global (Vietnam) Enterprise Corporation. Cleared Feb 2025. https://www.510kdatabase.net/k250044/ 2025-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k250044-celerity-5-hp-biological-indicator-fda-510k.jpg K250044 - Celerity 5 HP Biological Indicator (LCB052) K250044 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Feb 2025. https://www.510kdatabase.net/k250055/ 2025-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k250055-bps-bone-fragment-fixation-plates-fda-510k.jpg K250055 - BPS - Bone Fragment Fixation Plates, Screws and Washers K250055 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthonovis, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k250061/ 2025-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k250061-celerity-incubator-fda-510k.jpg K250061 - Celerity Incubator K250061 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Feb 2025. https://www.510kdatabase.net/k250066/ 2025-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k250066-resolution-clip-m00522600-fda-510k.jpg K250066 - Resolution Clip (M00522600) K250066 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Feb 2025. https://www.510kdatabase.net/k241327/ 2025-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k241327-navient-image-guide-navigation-system-fda-510k.jpg K241327 - Navient Image Guide Navigation System (955-NC-NC), Cranial K241327 is a FDA 510(k) cleared neurology medical device. Manufacturer: Claronav. Cleared Feb 2025. https://www.510kdatabase.net/k241488/ 2025-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k241488-trainfes-advance-fda-510k.jpg K241488 - TrainFES Advance K241488 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Trainfes. Cleared Feb 2025. https://www.510kdatabase.net/k241593/ 2025-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k241593-bonemetrics-us-fda-510k.jpg K241593 - BoneMetrics (US) K241593 is a FDA 510(k) cleared radiology medical device. Manufacturer: Gleamer Sas. Cleared Feb 2025. https://www.510kdatabase.net/k242352/ 2025-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k242352-accurate-mini-non-invasive-blood-fda-510k.jpg K242352 - Accurate Mini Non-invasive blood pressure monitor (AMB-001) K242352 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Accurate Meditech, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k242896/ 2025-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k242896-caliber-intramedullary-fixation-system-fda-510k.jpg K242896 - Caliber Intramedullary Fixation System K242896 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nvision Biomedical Technologies. Cleared Feb 2025. https://www.510kdatabase.net/k242983/ 2025-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k242983-croma-electrosurgical-generator-prd-fda-510k.jpg K242983 - CROMA Electrosurgical Generator (PRD-EMR-050) K242983 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Creo Medical, Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k243555/ 2025-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k243555-led-light-therapy-mask-e43-e32-e49b-fda-510k.jpg K243555 - LED light therapy mask (E43, E32, E49B, E49C, E100B, E100C, E103B, E104B, E106A, E108A) K243555 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Eyco Technology Co., Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k243580/ 2025-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k243580-graftgun-universal-graft-delivery-fda-510k.jpg K243580 - GraftGun Universal Graft Delivery System (GDS) K243580 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SurGenTec, LLC. Cleared Feb 2025. https://www.510kdatabase.net/k243790/ 2025-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k243790-gryphon-x-anchor-fda-510k.jpg K243790 - GRYPHON™ X Anchor K243790 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Mitek. Cleared Feb 2025. https://www.510kdatabase.net/k242916/ 2025-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k242916-largan-u38-color-polymacon-daily-wear-fda-510k.jpg K242916 - Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens K242916 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Largan Medical Co., Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k243138/ 2025-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k243138-geon-s2-nasal-aspirator-fda-510k.jpg K243138 - Geon (S2) Nasal Aspirator K243138 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Geon Corporation. Cleared Feb 2025. https://www.510kdatabase.net/k243333/ 2025-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k243333-rtop-fda-510k.jpg K243333 - rTOP K243333 is a FDA 510(k) cleared radiology medical device. Manufacturer: Roclub GmbH. Cleared Feb 2025. https://www.510kdatabase.net/k250068/ 2025-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k250068-venclose-digirf-generator-vcrfg1-fda-510k.jpg K250068 - Venclose digiRF Generator (VCRFG1) K250068 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Venclose, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k240402/ 2025-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k240402-cito-cbc-system-fda-510k.jpg K240402 - Cito CBC System K240402 is a FDA 510(k) cleared hematology medical device. Manufacturer: Cytochip, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k241368/ 2025-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k241368-sonicaid-team3-fda-510k.jpg K241368 - Sonicaid Team3 K241368 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Huntleigh Healthcare , Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k241375/ 2025-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k241375-identiti-porous-ti-interbody-system-fda-510k.jpg K241375 - IdentiTi Porous Ti Interbody System K241375 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine. Cleared Feb 2025. https://www.510kdatabase.net/k241454/ 2025-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k241454-minvitro-vitrification-straw-mvt-vsn-fda-510k.jpg K241454 - Minvitro® Vitrification Straw (MVT-VSN series, including MVT-VSNR, MVT-VSNY, MVT-VSNB, MVT-VSNG, MVT-VSNP) K241454 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Guangzhou Hehong Biotech Co., Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k241590/ 2025-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k241590-arm-blood-pressure-monitor-xy-b01-xy-fda-510k.jpg K241590 - Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09) K241590 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Guangdong Xinyu Electronic and Technology Co., Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k243146/ 2025-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k243146-icare-app-fda-510k.jpg K243146 - iCare APP K243146 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ihealth Labs, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k243182/ 2025-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k243182-anovo-instrument-arm-curved-scissors-fda-510k.jpg K243182 - Anovo Instrument ARM Curved Scissors K243182 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Momentis Surgical , Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k243268/ 2025-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k243268-tiptraq-ttq001-fda-510k.jpg K243268 - TipTraQ (TTQ001) K243268 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Pranaq Pte. , Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k243393/ 2025-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k243393-jmoon-nouvelleskin-facial-toning-fda-510k.jpg K243393 - JMOON NouvelleSkin Facial Toning Device (M30U PR, M30U MW, M30U SG, M30U SK, M30U MP) K243393 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Ulike Smart Electronics Co., Ltd.. Cleared Feb 2025. https://www.510kdatabase.net/k243908/ 2025-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k243908-tiger-2-system-fda-510k.jpg K243908 - Tiger 2 System K243908 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zavation Medical Products, LLC. Cleared Feb 2025. https://www.510kdatabase.net/k250035/ 2025-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k250035-contour-protgai-fda-510k.jpg K250035 - Contour ProtégéAI+ K250035 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mim Software, Inc.. Cleared Feb 2025. https://www.510kdatabase.net/k241193/ 2025-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k241193-agilis-multi-function-physical-therapy-fda-510k.jpg K241193 - AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.) K241193 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Marzzan Lucas Jorge. Cleared Jan 2025. https://www.510kdatabase.net/k241334/ 2025-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k241334-semi-floating-temporary-pacing-fda-510k.jpg K241334 - Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P) K241334 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k241348/ 2025-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k241348-swimcount-harvester-1-ml-fda-510k.jpg K241348 - SwimCount® Harvester (1 mL) K241348 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Motilitycount Aps. Cleared Jan 2025. https://www.510kdatabase.net/k241694/ 2025-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k241694-zetta-pacs-fda-510k.jpg K241694 - ZeTTA PACS K241694 is a FDA 510(k) cleared radiology medical device. Manufacturer: Tae Young Soft Co., Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k242135/ 2025-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k242135-synthgene-home-test-hcg-test-strip-fda-510k.jpg K242135 - Synthgene Home Test HCG Test Strip K242135 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Nanjing Synthgene Medical Technology Co., Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k242442/ 2025-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k242442-quick-start-orthopaedic-fixation-screw-fda-510k.jpg K242442 - Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw K242442 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Innovate Orthopaedics, Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k242966/ 2025-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k242966-gentuity-hf-oct-imaging-system-with-fda-510k.jpg K242966 - Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter K242966 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Gentuity, LLC. Cleared Jan 2025. https://www.510kdatabase.net/k242982/ 2025-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k242982-mobility-scooter-ms160a-fda-510k.jpg K242982 - Mobility Scooter (MS160A) K242982 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Suzhou Master Machinery Manufacturing Co.,Ltd. Cleared Jan 2025. https://www.510kdatabase.net/k243150/ 2025-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k243150-nuance-audio-hearing-aid-software-fda-510k.jpg K243150 - Nuance Audio Hearing Aid Software K243150 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Luxottica Group S.P.A.. Cleared Jan 2025. https://www.510kdatabase.net/k243441/ 2025-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k243441-nitrile-powder-free-exam-gloves-tested-fda-510k.jpg K243441 - Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid (Light blue, Dark blue) K243441 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Basic Medical Technology, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k243572/ 2025-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k243572-game-ready-system-550500-04-fda-510k.jpg K243572 - Game Ready system (550500-04) K243572 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Avanos Medical, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k243665/ 2025-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k243665-crius-peek-suture-anchor-system-thread-fda-510k.jpg K243665 - Crius PEEK Suture Anchor System (Thread-Fix Anchor) K243665 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: ZheJiang Decans Medical Devices Co., Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k243742/ 2025-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k243742-arthrex-dynanite-nitinol-staples-fda-510k.jpg K243742 - Arthrex DynaNite Nitinol Staples K243742 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k243820/ 2025-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k243820-hoover-negative-pressure-access-sheath-fda-510k.jpg K243820 - Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250 K243820 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Dornier Medtech America. Cleared Jan 2025. https://www.510kdatabase.net/k233956/ 2025-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k233956-aulisa-infant-oximeter-module-2nd-gen-fda-510k.jpg K233956 - Aulisa Infant Oximeter Module (2nd Gen.) (GA-OM0018) K233956 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Taiwan Aulisa Medical Devices Technologies, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k241270/ 2025-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k241270-btl-754-fda-510k.jpg K241270 - BTL-754 K241270 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: BTL Industries, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k241292/ 2025-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k241292-myshoulder-planner-53sswpl-fda-510k.jpg K241292 - MyShoulder Planner (5.3SSWPL) K241292 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Jan 2025. https://www.510kdatabase.net/k242568/ 2025-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k242568-wrist-blood-pressure-monitor-ohms11-fda-510k.jpg K242568 - Wrist Blood Pressure Monitor (OHMS11, OHMS12) K242568 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Zhongkemingwang Telecommunications Software Corp.. Cleared Jan 2025. https://www.510kdatabase.net/k242717/ 2025-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k242717-laboratorios-biogalenic-sterile-water-fda-510k.jpg K242717 - Laboratorios Biogalenic Sterile Water for Inhalation, USP K242717 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Laboratorios Biogalenic S.A. DE C.V.. Cleared Jan 2025. https://www.510kdatabase.net/k242757/ 2025-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k242757-rotarex-atherectomy-system-fda-510k.jpg K242757 - Rotarex Atherectomy System K242757 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bard Peripheral Vascular, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k243025/ 2025-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k243025-ureteral-access-sheath-fda-510k.jpg K243025 - Ureteral Access Sheath K243025 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Seplou (Zhuhai) Co., Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k243060/ 2025-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k243060-telerpm-gen2-blood-glucose-monitoring-fda-510k.jpg K243060 - TeleRPM Gen2 Blood Glucose Monitoring System K243060 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Guangdong Transtek Medical Electronics Co., Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k243202/ 2025-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k243202-mts-ceftobiprole-0002-32-gml-fda-510k.jpg K243202 - MTS Ceftobiprole 0.002-32 µg/mL K243202 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Liofilchem S. R. L.. Cleared Jan 2025. https://www.510kdatabase.net/k243410/ 2025-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k243410-simpli-collect-sti-test-fda-510k.jpg K243410 - simpli-COLLECT STI Test K243410 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Molecular. Cleared Jan 2025. https://www.510kdatabase.net/k243442/ 2025-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k243442-ibot-pmd-fda-510k.jpg K243442 - iBOT® PMD K243442 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Mobius Mobility. Cleared Jan 2025. https://www.510kdatabase.net/k243712/ 2025-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k243712-washercap-mini-fixation-system-model-45-fda-510k.jpg K243712 - WasherCap™ Mini Fixation System (Model 45) K243712 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Abanza Tecnomed S.L. Cleared Jan 2025. https://www.510kdatabase.net/k243726/ 2025-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k243726-osprey-suture-anchor-fda-510k.jpg K243726 - Osprey Suture Anchor K243726 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Responsive Arthroscopy, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k241915/ 2025-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k241915-caresuperb-covid-19-antigen-home-test-fda-510k.jpg K241915 - CareSuperb™ COVID-19 Antigen Home Test K241915 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Access Bio, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k242217/ 2025-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k242217-surcam-dental-implant-system-fda-510k.jpg K242217 - Surcam Dental Implant System K242217 is a FDA 510(k) cleared dental medical device. Manufacturer: Surcam Medical Devices and Developments, Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k243042/ 2025-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k243042-co-ablation-system-with-sterile-co-fda-510k.jpg K243042 - Co-Ablation System with Sterile Co-Ablation Probe K243042 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Hygea Medical Technology Co., Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k243117/ 2025-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k243117-digital-video-processor-fda-510k.jpg K243117 - Digital Video Processor K243117 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hunan Vathin Medical Instrument Co., Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k243213/ 2025-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k243213-self-forming-magnet-flex-sfm-fda-510k.jpg K243213 - Self-Forming Magnet (FLEX SFM) K243213 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: GI Windows, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k243387/ 2025-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k243387-gyder-hip-system-fda-510k.jpg K243387 - GYDER® Hip System K243387 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Gyder Surgical Pty, Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k243673/ 2025-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k243673-xenco-medical-cancellex-cervical-fda-510k.jpg K243673 - Xenco Medical CancelleX Cervical Interbody System K243673 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Xenco Medical, LLC. Cleared Jan 2025. https://www.510kdatabase.net/k243740/ 2025-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k243740-versalock-upper-limb-plating-system-fda-510k.jpg K243740 - Versalock Upper Limb Plating System K243740 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: GM Dos Reis Industria e Comercio Ltda.. Cleared Jan 2025. https://www.510kdatabase.net/k243374/ 2025-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k243374-hemosil-cl-hit-iggpf4-h-fda-510k.jpg K243374 - HemosIL CL HIT-IgG(PF4-H) K243374 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory (IL) Co.. Cleared Jan 2025. https://www.510kdatabase.net/k243423/ 2025-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k243423-led-light-therapy-mask-models-rb-008-fda-510k.jpg K243423 - LED Light Therapy Mask (Model(s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J, RB-008JB) K243423 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Rainbow Technology Co., Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k243439/ 2025-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k243439-medical-monitor-27hs714s-fda-510k.jpg K243439 - Medical Monitor (27HS714S) K243439 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lg Electronics.Inc. Cleared Jan 2025. https://www.510kdatabase.net/k243501/ 2025-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k243501-3m-attest-super-rapid-steam-extended-fda-510k.jpg K243501 - 3M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE K243501 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Jan 2025. https://www.510kdatabase.net/k243698/ 2025-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k243698-alignment-system-cranial-with-fda-510k.jpg K243698 - Alignment System Cranial, with Alignment Software Cranial with LITT K243698 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Jan 2025. https://www.510kdatabase.net/k244025/ 2025-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k244025-argo-knotless-genesys-anchor-fda-510k.jpg K244025 - Argo Knotless GENESYS Anchor K244025 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Conmed Corporation. Cleared Jan 2025. https://www.510kdatabase.net/k244027/ 2025-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k244027-sansa-hsat-fda-510k.jpg K244027 - SANSA HSAT K244027 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Huxley Medical. Cleared Jan 2025. https://www.510kdatabase.net/k231297/ 2025-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k231297-firstar-dental-unit-fda-510k.jpg K231297 - Firstar Dental Unit K231297 is a FDA 510(k) cleared dental medical device. Manufacturer: Firstar Dental Company. Cleared Jan 2025. https://www.510kdatabase.net/k241266/ 2025-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k241266-imaging-system-of-positron-emission-fda-510k.jpg K241266 - Imaging system of positron emission and X-ray computed tomography (DigitMI 930) K241266 is a FDA 510(k) cleared radiology medical device. Manufacturer: Raysolution Healthcare Co., Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k242941/ 2025-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k242941-co2-laser-therapy-systems-she-lsp003-1-fda-510k.jpg K242941 - CO2 Laser Therapy Systems (SHE-LSP003-1) K242941 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Beijing Sano Laser S&T Development Co.,Ltd. Cleared Jan 2025. https://www.510kdatabase.net/k243229/ 2025-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k243229-bunkerhill-avc-fda-510k.jpg K243229 - Bunkerhill AVC K243229 is a FDA 510(k) cleared radiology medical device. Manufacturer: BunkerHill Health. Cleared Jan 2025. https://www.510kdatabase.net/k250014/ 2025-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k250014-symani-surgical-system-820-03830-fda-510k.jpg K250014 - Symani Surgical System (820-03830) K250014 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medical Microinstruments, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k241057/ 2025-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k241057-enhanced-handheld-pain-relief-laser-fda-510k.jpg K241057 - Enhanced Handheld Pain Relief Laser Instrument (GD-P-E) K241057 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Wuhan Guangdun Technology Co.,Ltd... Cleared Jan 2025. https://www.510kdatabase.net/k241107/ 2025-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k241107-indiba-diathermia-radiofrequency-deep-fda-510k.jpg K241107 - Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ) K241107 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Indiba S. A. U.. Cleared Jan 2025. https://www.510kdatabase.net/k241220/ 2025-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k241220-tina-quant-lipoproteina-gen2-molarity-fda-510k.jpg K241220 - Tina-quant Lipoprotein(a) Gen.2 Molarity K241220 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Operations. Cleared Jan 2025. https://www.510kdatabase.net/k241232/ 2025-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k241232-galen-second-read-fda-510k.jpg K241232 - Galen™ Second Read™ K241232 is a FDA 510(k) cleared pathology medical device. Manufacturer: Ibex Medical Analytics , Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k241239/ 2025-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k241239-organprotex-htk-solution-fda-510k.jpg K241239 - OrganProtex HTK Solution K241239 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Bridge TO Life, Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k241793/ 2025-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k241793-automatic-core-biopsy-instrument-semi-fda-510k.jpg K241793 - Automatic Core Biopsy Instrument/ Semi-Automatic Core Biopsy Instrument/ Disposable Coaxial Biopsy Needle K241793 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Zhejiang Curaway Medical Technology Co., Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k242322/ 2025-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k242322-bone-marrow-biopsy-needle-fda-510k.jpg K242322 - Bone Marrow Biopsy Needle K242322 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Zhejiang Curaway Medical Technology Co., Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k243657/ 2025-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k243657-clearpoint-system-software-version-30-fda-510k.jpg K243657 - ClearPoint System (Software Version 3.0) K243657 is a FDA 510(k) cleared neurology medical device. Manufacturer: ClearPoint Neuro, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k243739/ 2025-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k243739-axcess-expandable-interbody-system-fda-510k.jpg K243739 - AxCess® Expandable Interbody System K243739 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Elliquence, LLC. Cleared Jan 2025. https://www.510kdatabase.net/k244023/ 2025-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k244023-magentiq-colo-me-apds-fda-510k.jpg K244023 - MAGENTIQ-COLO (ME-APDS) K244023 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Magentiq Eye, Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k241199/ 2025-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k241199-rotatable-connector-5944rl-fda-510k.jpg K241199 - Rotatable Connector (5944RL) K241199 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Launch Electrical Co., Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k241234/ 2025-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k241234-ots-25-l-100-5-fda-510k.jpg K241234 - OTS 25-L (100-5) K241234 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ots Medical , Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k241367/ 2025-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k241367-rf-cannula-fda-510k.jpg K241367 - RF Cannula K241367 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shanghai Samedical & Plastic Instruments Co., Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k241728/ 2025-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k241728-vios-monitoring-systemtm-model-2050-fda-510k.jpg K241728 - Vios Monitoring System(TM) Model 2050 K241728 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Murata Vios, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k241819/ 2025-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k241819-cephninja-fda-510k.jpg K241819 - CephNinja K241819 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cyncronus, LLC. Cleared Jan 2025. https://www.510kdatabase.net/k242714/ 2025-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k242714-mobility-scooter-s-01-fda-510k.jpg K242714 - Mobility Scooter (S-01) K242714 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zhejiang Seedream Medical Equipment Co., Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k243158/ 2025-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k243158-terarecon-aortact-110-fda-510k.jpg K243158 - TeraRecon Aorta.CT (1.1.0) K243158 is a FDA 510(k) cleared radiology medical device. Manufacturer: Terarecon,Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k243219/ 2025-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k243219-monarch-platform-mon-000008-fda-510k.jpg K243219 - MONARCH™ Platform (MON-000008) K243219 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Auris Health, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k243624/ 2025-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k243624-acu-sinch-knotless-mini-fda-510k.jpg K243624 - Acu-Sinch Knotless Mini K243624 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Acumed, LLC. Cleared Jan 2025. https://www.510kdatabase.net/k243668/ 2025-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k243668-prolift-pivot-expandable-spacer-system-fda-510k.jpg K243668 - ProLift Pivot Expandable Spacer System K243668 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k240311/ 2025-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k240311-jett-medical-ii-fda-510k.jpg K240311 - JETT Medical II K240311 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Compex, Spol, S.R.O.. Cleared Jan 2025. https://www.510kdatabase.net/k241357/ 2025-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k241357-xt3-system-fda-510k.jpg K241357 - XT3 System K241357 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biodynamik, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k241956/ 2025-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k241956-single-use-digital-flexible-fda-510k.jpg K241956 - Single-Use Digital Flexible Ureteroscope (PUR12-1, PUR12-2, PUR12-3, PUR12-4, PUR12-5, PUR12-6, PUR12-S, PUR12-S1, PUR12-S2) K241956 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hunan Endoso Life Technology Co., Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k242446/ 2025-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k242446-persyst-15-eeg-review-and-analysis-fda-510k.jpg K242446 - Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) K242446 is a FDA 510(k) cleared neurology medical device. Manufacturer: Persyst Development Corporation. Cleared Jan 2025. https://www.510kdatabase.net/k242835/ 2025-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k242835-suture-tool-system-fda-510k.jpg K242835 - Suture-TOOL System K242835 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Suturion AB. Cleared Jan 2025. https://www.510kdatabase.net/k243008/ 2025-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k243008-arthrex-nanoscope-system-fda-510k.jpg K243008 - Arthrex NanoScope System K243008 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Arthrex, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k243139/ 2025-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k243139-reverso-pro-system-fda-510k.jpg K243139 - Reverso Pro System K243139 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Indiba S. A. U.. Cleared Jan 2025. https://www.510kdatabase.net/k243350/ 2025-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k243350-rapid-neuro3d-fda-510k.jpg K243350 - Rapid Neuro3D K243350 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ischemaview, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k243976/ 2025-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k243976-zeroclear-bag-access-423100-fda-510k.jpg K243976 - ZeroClear™ Bag Access (423100) K243976 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Epic Medical Pte. , Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k243977/ 2025-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k243977-emphasys-acetabular-system-fda-510k.jpg K243977 - EMPHASYS Acetabular System K243977 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Ireland UC. Cleared Jan 2025. https://www.510kdatabase.net/k243982/ 2025-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k243982-nicolet-edx-fda-510k.jpg K243982 - Nicolet EDX K243982 is a FDA 510(k) cleared neurology medical device. Manufacturer: Natus Neurology Incorporated. Cleared Jan 2025. https://www.510kdatabase.net/k243985/ 2025-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k243985-rio-drug-reconstitution-transfer-device-fda-510k.jpg K243985 - Rio™ Drug Reconstitution Transfer Device K243985 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Icu Medical, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k241443/ 2025-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k241443-sutil-luxe-personal-lubricant-models-fda-510k.jpg K241443 - Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011) K241443 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Hathor Professional Skincare , Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k241444/ 2025-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k241444-biliary-pancreaticobiliary-scope-system-fda-510k.jpg K241444 - Biliary Pancreaticobiliary Scope System K241444 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Shenzhen HugeMed Medical Technical Development Co., Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k242288/ 2025-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k242288-advanced-cryo-wart-remover-fda-510k.jpg K242288 - Advanced Cryo Wart Remover K242288 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medical Brands Laboratories B.V.. Cleared Jan 2025. https://www.510kdatabase.net/k243303/ 2025-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k243303-ziehm-vision-rfd-3d-fda-510k.jpg K243303 - Ziehm Vision RFD 3D K243303 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ziehm Imaging GmbH. Cleared Jan 2025. https://www.510kdatabase.net/k243929/ 2025-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k243929-oligio-x-fda-510k.jpg K243929 - Oligio X K243929 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wontech Co., Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k243955/ 2025-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k243955-precision-ai-surgical-planning-system-fda-510k.jpg K243955 - Precision AI Surgical Planning System (PAI-SPS) K243955 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Precision AI Pty, Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k241910/ 2025-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k241910-neonav-ecg-tip-location-system-fda-510k.jpg K241910 - Neonav ECG Tip Location System K241910 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Navi Medical Technologies. Cleared Jan 2025. https://www.510kdatabase.net/k240217/ 2025-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k240217-cobas-liat-ctng-nucleic-acid-test-fda-510k.jpg K240217 - cobas® liat CT/NG nucleic acid test K240217 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Molecular Systems, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k241142/ 2025-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k241142-maxis-stapes-prosthesis-mloop-stapes-fda-510k.jpg K241142 - mAXIS Stapes Prosthesis, mLOOP Stapes Prosthesis, mZAM Stapes Prosthesis and mFIX Stapes Prosthesis K241142 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Med-El Elektromedizinische Ger?te GmbH. Cleared Jan 2025. https://www.510kdatabase.net/k241261/ 2025-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k241261-mclip-partial-prosthesis-mclip-arc-fda-510k.jpg K241261 - mCLIP Partial Prosthesis, mCLIP ARC Partial Prosthesis, mXACT Partial Prosthesis and mXACT PRO Partial Prosthesis Kit K241261 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Med-El Elektromedizinische Ger?te GmbH. Cleared Jan 2025. https://www.510kdatabase.net/k241269/ 2025-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k241269-mxact-total-prosthesis-offcenter-mxact-fda-510k.jpg K241269 - mXACT Total Prosthesis Offcenter, mXACT Total Prosthesis Center and mXACT PRO Total Prosthesis Kit K241269 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Med-El Elektromedizinische Ger?te GmbH. Cleared Jan 2025. https://www.510kdatabase.net/k241333/ 2025-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k241333-geniant-cranial-navigated-fda-510k.jpg K241333 - Geniant Cranial (Navigated Neurosurgical Positioning Robot) K241333 is a FDA 510(k) cleared neurology medical device. Manufacturer: KOH YOUNG TECHNOLOGY, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k241949/ 2025-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k241949-digital-color-doppler-ultrasound-fda-510k.jpg K241949 - Digital Color Doppler Ultrasound System (P60 Series) K241949 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sonoscape Medical Corp.. Cleared Jan 2025. https://www.510kdatabase.net/k242051/ 2025-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k242051-versad-delivery-catheter-fda-510k.jpg K242051 - VersaD Delivery Catheter K242051 is a FDA 510(k) cleared neurology medical device. Manufacturer: Unity Medical, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k242064/ 2025-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k242064-omni-directional-multi-unit-abutment-fda-510k.jpg K242064 - Omni-Directional Multi-unit Abutment System (Trade Name: Omnibut™) K242064 is a FDA 510(k) cleared dental medical device. Manufacturer: Smart Denture Conversions, LLC. Cleared Jan 2025. https://www.510kdatabase.net/k242171/ 2025-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k242171-techcare-trauma-fda-510k.jpg K242171 - TechCare Trauma K242171 is a FDA 510(k) cleared radiology medical device. Manufacturer: Milvue. Cleared Jan 2025. https://www.510kdatabase.net/k242336/ 2025-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k242336-hygh-tec-drainage-ii-fda-510k.jpg K242336 - hygh-tec Drainage II K242336 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Amb Medtec. Cleared Jan 2025. https://www.510kdatabase.net/k242374/ 2025-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k242374-ulspira-ts-nitric-oxide-therapy-system-fda-510k.jpg K242374 - ULSPIRA TS™ Nitric Oxide Therapy System K242374 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Airgas Therapeutics, LLC. Cleared Jan 2025. https://www.510kdatabase.net/k242608/ 2025-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k242608-embozene-color-advanced-microspheres-fda-510k.jpg K242608 - Embozene Color-Advanced Microspheres K242608 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k242705/ 2025-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k242705-streamline-unipolar-pediatric-fda-510k.jpg K242705 - Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500) K242705 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k242765/ 2025-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k242765-electronic-apex-locator-alpha-apex-i-fda-510k.jpg K242765 - Electronic Apex Locator (Alpha Apex I) K242765 is a FDA 510(k) cleared dental medical device. Manufacturer: SHENZHEN SUPERLINE TECHNOLOGY CO., LTD.. Cleared Jan 2025. https://www.510kdatabase.net/k242825/ 2025-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k242825-prenuvo-body-composition-fda-510k.jpg K242825 - Prenuvo Body Composition K242825 is a FDA 510(k) cleared radiology medical device. Manufacturer: Prenuvo. Cleared Jan 2025. https://www.510kdatabase.net/k242860/ 2025-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k242860-type-5-integrating-indicator-for-steam-fda-510k.jpg K242860 - Type 5 Integrating Indicator for Steam (CSPN-15) K242860 is a FDA 510(k) cleared general hospital medical device. Manufacturer: True Indicating, LLC. Cleared Jan 2025. https://www.510kdatabase.net/k243067/ 2025-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k243067-the-ethicon-total-energy-system-fda-510k.jpg K243067 - The ETHICON™ Total Energy System K243067 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon Endo-Surgery, LLC (A Johnson and Johnson Company). Cleared Jan 2025. https://www.510kdatabase.net/k243218/ 2025-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k243218-tbs-insight-v4-fda-510k.jpg K243218 - TBS iNsight (V4) K243218 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medimaps Group SA. Cleared Jan 2025. https://www.510kdatabase.net/k243249/ 2025-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k243249-trialtis-spine-system-fda-510k.jpg K243249 - TriALTIS™ Spine System K243249 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International SARL. Cleared Jan 2025. https://www.510kdatabase.net/k243291/ 2025-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k243291-goldtrace-fetal-spiral-electrode-fse-fda-510k.jpg K243291 - Goldtrace Fetal Spiral Electrode (FSE) (CNS000004) K243291 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Neoventa Medical AB. Cleared Jan 2025. https://www.510kdatabase.net/k243315/ 2025-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k243315-progrip-self-gripping-polypropylene-mesh-fda-510k.jpg K243315 - ProGrip™ Self-Gripping Polypropylene Mesh K243315 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sofradim Production. Cleared Jan 2025. https://www.510kdatabase.net/k243502/ 2025-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k243502-evis-eus-endoscopic-ultrasound-center-fda-510k.jpg K243502 - EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3 (OLYMPUS EU-ME3) K243502 is a FDA 510(k) cleared radiology medical device. Manufacturer: Olympus Medical Systems Corporation. Cleared Jan 2025. https://www.510kdatabase.net/k243545/ 2025-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k243545-philips-reusable-ecg-lead-sets-and-fda-510k.jpg K243545 - Philips Reusable ECG Lead Sets and Trunk Cables : Model Number,Model Name: 989803170171, OR 3-Lead ECG Trunk Cable, AAMI/IEC K243545 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Philips Medizin Systeme B?blingen GmbH. Cleared Jan 2025. https://www.510kdatabase.net/k243568/ 2025-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k243568-teslatome-bipolar-sphincterotome-fda-510k.jpg K243568 - Teslatome Bipolar Sphincterotome K243568 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Wilson-Cook Medical, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k243605/ 2025-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k243605-aurora-fda-510k.jpg K243605 - Aurora K243605 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems Israel, Functional Imaging. Cleared Jan 2025. https://www.510kdatabase.net/k243606/ 2025-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k243606-babyroo-tn300-fda-510k.jpg K243606 - Babyroo TN300 K243606 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Draeger Medical Systems, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k243706/ 2025-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k243706-mastergraft-matrix-ext-fda-510k.jpg K243706 - Mastergraft Matrix EXT K243706 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k243892/ 2025-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k243892-affera-integrated-mapping-system-fda-510k.jpg K243892 - Affera Integrated Mapping System K243892 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k243935/ 2025-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k243935-aptima-cmv-quant-assay-fda-510k.jpg K243935 - Aptima CMV Quant Assay K243935 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Hologic, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k243941/ 2025-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k243941-hydropicc-4fr-single-lumen-marked-fda-510k.jpg K243941 - HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201) K243941 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Access Vascular, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/den230051/ 2025-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/den230051-myocene-fda-510k.jpg DEN230051 - Myocene DEN230051 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Myocene. Cleared Jan 2025. https://www.510kdatabase.net/k233770/ 2025-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k233770-pepper-ems-training-system-fda-510k.jpg K233770 - Pepper EMS Training System K233770 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Pepper Interactive, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k240197/ 2025-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k240197-cobas-liat-ctngmg-nucleic-acid-test-fda-510k.jpg K240197 - cobas® liat CT/NG/MG nucleic acid test K240197 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Molecular Systems, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k241113/ 2025-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k241113-vivix-m-fda-510k.jpg K241113 - VIVIX-M K241113 is a FDA 510(k) cleared radiology medical device. Manufacturer: Vieworks Co., Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k241176/ 2025-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k241176-alere-nt-probnp-for-alinity-i-reagent-fda-510k.jpg K241176 - Alere NT-proBNP for Alinity i Reagent Kit K241176 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Axis-Shield Diagnostics, Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k241217/ 2025-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k241217-cloudhrv-system-100-01-001-fda-510k.jpg K241217 - CloudHRV™ System (100-01-001) K241217 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inmedix, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k241736/ 2025-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k241736-remunity-20-pump-for-remodulin-fda-510k.jpg K241736 - Remunity 2.0 Pump for Remodulin (treprostinil) Injection K241736 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Deka Research and Development Corp.. Cleared Jan 2025. https://www.510kdatabase.net/k242416/ 2025-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k242416-single-use-flexible-bronchoscope-bc-fda-510k.jpg K242416 - Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11, BC-E1E12, BC-E1H10, BC-E1H11, BC-E1H12 K242416 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Hunan Vathin Medical Instrument Co., Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k242522/ 2025-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k242522-second-opinion-cc-fda-510k.jpg K242522 - Second Opinion CC K242522 is a FDA 510(k) cleared radiology medical device. Manufacturer: Pearl, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k242715/ 2025-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k242715-pearl-clear-aligner-fda-510k.jpg K242715 - Pearl Clear Aligner K242715 is a FDA 510(k) cleared dental medical device. Manufacturer: Pearl Digital, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k242834/ 2025-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k242834-system-9-sterile-battery-container-fda-510k.jpg K242834 - System 9 Sterile Battery Container K242834 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Stryker Instruments. Cleared Jan 2025. https://www.510kdatabase.net/k243256/ 2025-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k243256-welllife-covid-19-influenza-ab-home-test-fda-510k.jpg K243256 - WELLlife™ COVID-19 / Influenza A&B Home Test K243256 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Wondfo USA Co., Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k243289/ 2025-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k243289-addnox-bpspm1-fda-510k.jpg K243289 - ADDNOX (BPSPM1) K243289 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nu Eyne Co., Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k243848/ 2025-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k243848-cala-kiq-fda-510k.jpg K243848 - Cala kIQ K243848 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cala Health, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k243885/ 2025-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k243885-biofire-filmarray-gastrointestinal-gi-fda-510k.jpg K243885 - BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid K243885 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Biofire Diagnostics, LLC. Cleared Jan 2025. https://www.510kdatabase.net/k244048/ 2025-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k244048-medi-lift-mask-fda-510k.jpg K244048 - Medi Lift Mask K244048 is a FDA 510(k) cleared neurology medical device. Manufacturer: Ya-Man, Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k241096/ 2025-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k241096-venera-608-deep-vein-thrombosis-dvt-fda-510k.jpg K241096 - Venera 608 Deep Vein Thrombosis (DVT) Prevention System K241096 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Suzhou Minhua Medical Apparatus Supplies Co., Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k241512/ 2025-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k241512-electrode-pad-fda-510k.jpg K241512 - Electrode Pad K241512 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Deliduo Medical Technology Co.,Ltd. Cleared Jan 2025. https://www.510kdatabase.net/k242109/ 2025-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k242109-xpert-xpress-cov-2-plus-xprs-cov2-10-fda-510k.jpg K242109 - Xpert® Xpress CoV-2 plus (XPRS-COV2-10) K242109 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Cepheid. Cleared Jan 2025. https://www.510kdatabase.net/k242229/ 2025-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k242229-micro-ace-gold-advanced-micro-access-fda-510k.jpg K242229 - Micro Ace Gold Advanced Micro Access System K242229 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k242541/ 2025-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k242541-gem-zipclip-fda-510k.jpg K242541 - GEM ZIPCLIP K242541 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Synovis Micro Companies Alliance A Subsidiary of Baxter Int. Cleared Jan 2025. https://www.510kdatabase.net/k242634/ 2025-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k242634-purastat-fda-510k.jpg K242634 - PuraStat K242634 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: 3-D Matrix Europe SAS. Cleared Jan 2025. https://www.510kdatabase.net/k242667/ 2025-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k242667-aerochamber2go-anti-static-valved-fda-510k.jpg K242667 - AeroChamber2go Anti-Static Valved Holding Chamber K242667 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Trudell Medical International. Cleared Jan 2025. https://www.510kdatabase.net/k242873/ 2025-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k242873-ventrax-delivery-system-fda-510k.jpg K242873 - Ventrax™ Delivery System K242873 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k242935/ 2025-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k242935-respiration-data-management-software-fda-510k.jpg K242935 - Respiration Data Management Software (PAP Link PC) K242935 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: BMC Medical Co., Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k242936/ 2025-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k242936-powder-free-nitrile-examination-gloves-fda-510k.jpg K242936 - Powder Free Nitrile Examination Gloves (Blue, Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate K242936 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sunray Medical Products, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k243065/ 2025-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k243065-cardiac-guidance-fda-510k.jpg K243065 - Cardiac Guidance K243065 is a FDA 510(k) cleared radiology medical device. Manufacturer: Caption Health, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k243284/ 2025-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k243284-relizorb-100300-100301-fda-510k.jpg K243284 - RELiZORB (100300/ 100301) K243284 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Alcresta Therapeutics, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k243328/ 2025-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k243328-ziehm-vision-rfd-fda-510k.jpg K243328 - Ziehm Vision RFD K243328 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ziehm Imaging GmbH. Cleared Jan 2025. https://www.510kdatabase.net/k243569/ 2025-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k243569-trimed-wrist-fixation-system-volar-fda-510k.jpg K243569 - TriMed Wrist Fixation System (Volar Bearing Plates) K243569 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: TriMed, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k243573/ 2025-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k243573-fastep-early-pregnancy-rapid-test-strip-fda-510k.jpg K243573 - FaStep Early Pregnancy Rapid Test Strip K243573 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Assure Tech., LLC. Cleared Jan 2025. https://www.510kdatabase.net/k243858/ 2025-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k243858-teg-6s-hemostasis-system-citrated-k-kh-fda-510k.jpg K243858 - TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge K243858 is a FDA 510(k) cleared hematology medical device. Manufacturer: Haemonetics Corporation. Cleared Jan 2025. https://www.510kdatabase.net/k243860/ 2025-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k243860-atriclip-pro-mini-laa-exclusion-system-fda-510k.jpg K243860 - AtriClip PRO-Mini LAA Exclusion System (PROM) K243860 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: AtriCure, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k243946/ 2025-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k243946-effortmed-spinal-fixation-system-fda-510k.jpg K243946 - EffortMed Spinal Fixation System K243946 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Effortmed, LLC. Cleared Jan 2025. https://www.510kdatabase.net/k241037/ 2025-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k241037-abl90-flex-plus-system-fda-510k.jpg K241037 - ABL90 FLEX PLUS System K241037 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Radiometer Medicals Aps. Cleared Jan 2025. https://www.510kdatabase.net/k241066/ 2025-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k241066-bb-613-bpm-fda-510k.jpg K241066 - BB-613-BPM K241066 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biobeat Technologies , Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k241166/ 2025-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k241166-uct-550-fda-510k.jpg K241166 - uCT 550 K241166 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k241180/ 2025-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k241180-consensus-knee-system-with-tinbn-fda-510k.jpg K241180 - Consensus Knee System with TiNbN K241180 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Shalby Advanced Technologies. Cleared Jan 2025. https://www.510kdatabase.net/k241278/ 2025-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k241278-asept-glide-peritoneal-drainage-system-fda-510k.jpg K241278 - ASEPT® Glide Peritoneal Drainage System K241278 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Pfm Medical, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k242205/ 2025-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k242205-spectomed-v10-fda-510k.jpg K242205 - SpectoMed (v1.0) K242205 is a FDA 510(k) cleared radiology medical device. Manufacturer: Specto Medical. Cleared Jan 2025. https://www.510kdatabase.net/k242672/ 2025-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k242672-zoom-system-fda-510k.jpg K242672 - Zoom System K242672 is a FDA 510(k) cleared neurology medical device. Manufacturer: Imperative Care, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k243272/ 2025-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k243272-locator-angled-abutment-fda-510k.jpg K243272 - LOCATOR Angled Abutment K243272 is a FDA 510(k) cleared dental medical device. Manufacturer: Zest Anchors, LLC. Cleared Jan 2025. https://www.510kdatabase.net/k243297/ 2025-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k243297-apro-70-swift-catheter-fda-510k.jpg K243297 - APRO 70 Swift Catheter K243297 is a FDA 510(k) cleared neurology medical device. Manufacturer: Alembic, LLC. Cleared Jan 2025. https://www.510kdatabase.net/k243452/ 2025-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k243452-orthoscan-versa-mini-c-arm-fda-510k.jpg K243452 - Orthoscan VERSA Mini C-Arm K243452 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ziehm-Orthoscan, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k243577/ 2025-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k243577-radical-the-dude-8f-guide-catheter-fda-510k.jpg K243577 - Radical the Dude 8F Guide Catheter K243577 is a FDA 510(k) cleared neurology medical device. Manufacturer: Maduro Medical, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k243904/ 2025-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k243904-elegance-anterior-cervical-plate-fda-510k.jpg K243904 - Elegance® Anterior Cervical plate K243904 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Clariance. Cleared Jan 2025. https://www.510kdatabase.net/k233452/ 2025-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k233452-vivo-45-ls-fda-510k.jpg K233452 - Vivo 45 LS K233452 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Breas Medical AB. Cleared Jan 2025. https://www.510kdatabase.net/k241059/ 2025-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k241059-pantheon-proximal-femur-reconstruction-fda-510k.jpg K241059 - Pantheon Proximal Femur Reconstruction (PFR) System K241059 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Adler Ortho S.P.A. Cleared Jan 2025. https://www.510kdatabase.net/k241200/ 2025-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k241200-spotlightspotlight-duo-with-low-dose-fda-510k.jpg K241200 - SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option K241200 is a FDA 510(k) cleared radiology medical device. Manufacturer: Arineta , Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k241431/ 2025-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k241431-arm-type-fully-automatic-digital-blood-fda-510k.jpg K241431 - Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-62D0L, DBP-62D0B, DBP-61D0, DBP-61D0L, DBP-6293L, DBP-6293B, DBP-6193) K241431 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Joytech Healthcare Co. , Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k242030/ 2025-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k242030-megagen-dental-implant-abutment-fda-510k.jpg K242030 - MegaGen Dental Implant Abutment K242030 is a FDA 510(k) cleared dental medical device. Manufacturer: Megagen Implant Co., Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k242680/ 2025-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k242680-letsgetchecked-impress-fda-510k.jpg K242680 - LetsGetChecked Impress K242680 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Privapath Diagnostics Ltd (Dba Letsgetchecked). Cleared Jan 2025. https://www.510kdatabase.net/k242689/ 2025-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k242689-aami-level-4-protective-fda-510k.jpg K242689 - AAMI Level 4 Protective K242689 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Azac Group. Cleared Jan 2025. https://www.510kdatabase.net/k243262/ 2025-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k243262-quickfinder-covid-19flu-antigen-self-fda-510k.jpg K243262 - QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test K243262 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Osang, LLC. Cleared Jan 2025. https://www.510kdatabase.net/k243271/ 2025-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k243271-mentor-memoryshape-resterilizable-gel-fda-510k.jpg K243271 - MENTOR™ MemoryShape™ Resterilizable Gel Breast Implant Sizer K243271 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Mentor Worldwide, LLC. Cleared Jan 2025. https://www.510kdatabase.net/k243295/ 2025-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k243295-initia-knee-system-fda-510k.jpg K243295 - Initia Knee System K243295 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Kyocera Medical Technologies, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k243527/ 2025-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k243527-high-flow-insufflation-unit-uhi-4-fda-510k.jpg K243527 - High Flow Insufflation Unit (UHI-4) K243527 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Olympus Medical Systems Corporation. Cleared Jan 2025. https://www.510kdatabase.net/k243533/ 2025-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k243533-sterilized-eol-auto-lancet-fda-510k.jpg K243533 - Sterilized Eol Auto Lancet K243533 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Hlb Co., Ltd. Healthcare. Cleared Jan 2025. https://www.510kdatabase.net/k243791/ 2025-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k243791-air-pressure-therapy-system-fda-510k.jpg K243791 - Air Pressure Therapy System K243791 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Xiamen Weiyou Intelligent Technology Co., Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k243890/ 2025-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k243890-arthrex-intramedullary-nails-fda-510k.jpg K243890 - Arthrex Intramedullary Nails K243890 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k243909/ 2025-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k243909-precision1-fda-510k.jpg K243909 - Precision1 K243909 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Alcon Laboratories, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k243950/ 2025-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k243950-arvis-shoulder-fda-510k.jpg K243950 - ARVIS® Shoulder K243950 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Kico Knee Innovation Company Pty, Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k243836/ 2025-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k243836-mentor-cpx-4-plus-enhance-breast-fda-510k.jpg K243836 - Mentor™ CPX ™ 4 PLUS Enhance Breast Tissue Expander K243836 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Mentor Worldwide, LLC. Cleared Jan 2025. https://www.510kdatabase.net/k241641/ 2025-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k241641-electric-wheelchair-ye200-fda-510k.jpg K241641 - Electric Wheelchair (YE200) K241641 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Shenzhen Yattll Industry Co., Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k240267/ 2025-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k240267-klaxon-twist-fda-510k.jpg K240267 - Klaxon (Twist) K240267 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Klaxon Mobility GmbH. Cleared Jan 2025. https://www.510kdatabase.net/k241009/ 2025-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k241009-pericalm-patterns-30-fda-510k.jpg K241009 - PeriCALM Patterns 3.0 K241009 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Perigen, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k241064/ 2025-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k241064-unscented-tampon-fda-510k.jpg K241064 - Unscented Tampon K241064 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shandong Intco Hygiene Products Co., Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k241174/ 2025-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k241174-intrabeam-700-fda-510k.jpg K241174 - INTRABEAM (700) K241174 is a FDA 510(k) cleared radiology medical device. Manufacturer: Carl Zeiss Meditec, AG. Cleared Jan 2025. https://www.510kdatabase.net/k241676/ 2025-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k241676-triverity-fda-510k.jpg K241676 - TriVerity K241676 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Inflammatix, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k241764/ 2025-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k241764-mould-probe-mr-safe-fda-510k.jpg K241764 - Mould Probe MR Safe K241764 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k241781/ 2025-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k241781-solo-pace-control-fda-510k.jpg K241781 - Solo Pace Control K241781 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Solo Pace, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k241891/ 2025-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k241891-screendx-fda-510k.jpg K241891 - ScreenDx K241891 is a FDA 510(k) cleared radiology medical device. Manufacturer: Imvaria, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k242071/ 2025-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k242071-xpert-xpress-cov-2flursv-plus-fda-510k.jpg K242071 - Xpert Xpress CoV-2/Flu/RSV plus K242071 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Cepheid. Cleared Jan 2025. https://www.510kdatabase.net/k242228/ 2025-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k242228-triopsy-actuator-tmsdgb-fda-510k.jpg K242228 - Triopsy Actuator (TMSDGB) K242228 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Triopsy Medical, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k242366/ 2025-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k242366-overcem-sa-universal-fda-510k.jpg K242366 - OverCEM SA Universal K242366 is a FDA 510(k) cleared dental medical device. Manufacturer: Overfibers S.R.L.. Cleared Jan 2025. https://www.510kdatabase.net/k242528/ 2025-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k242528-blood-pressure-monitor-rak260-rak262-fda-510k.jpg K242528 - Blood Pressure Monitor (RAK260, RAK262, RAK263, RAK266, RAK268, RAK269, RAK282, RAK283, RAK286, RAK288, RAK289, RAK291, RAK292, RAK293, RAK295, RAK296, RAK297, RAK298) K242528 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Ruiankang Technology Co., Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k242767/ 2025-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k242767-safecare-urinary-tract-infection-test-fda-510k.jpg K242767 - Safecare Urinary Tract Infection Test K242767 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Safecare Biotech (Hangzhou) Co., Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k242877/ 2025-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k242877-biocode-gastrointestinal-pathogen-fda-510k.jpg K242877 - BioCode Gastrointestinal Pathogen Panel (GPP) K242877 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Applied BioCode, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k242901/ 2025-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k242901-zziren-orogastric-tube-fda-510k.jpg K242901 - ZZIREN™ Orogastric Tube K242901 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Tools For Surgery, LLC. Cleared Jan 2025. https://www.510kdatabase.net/k243111/ 2025-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k243111-bowhead-era-wheelchairs-fda-510k.jpg K243111 - Bowhead ERA Wheelchairs K243111 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Bowhead Design Corp.. Cleared Jan 2025. https://www.510kdatabase.net/k243195/ 2025-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k243195-arthrex-ss-val-and-val-kreulock-fda-510k.jpg K243195 - Arthrex SS VAL and VAL KreuLock™ Compression Screw System K243195 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k243477/ 2025-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k243477-universal-tendon-spacer-fda-510k.jpg K243477 - Universal Tendon Spacer K243477 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Askorn Medical. Cleared Jan 2025. https://www.510kdatabase.net/k243492/ 2025-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k243492-ulike-reglow-light-therapy-device-um10-fda-510k.jpg K243492 - Ulike Reglow Light Therapy Device (UM10) K243492 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Ulike Smart Electronics Co., Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k243806/ 2025-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k243806-safety-winged-blood-collection-sets-fda-510k.jpg K243806 - Safety Winged Blood Collection Sets K243806 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Promisemed Hangzhou Meditech Co., Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k243811/ 2025-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k243811-erchonia-zerona-vz8-fda-510k.jpg K243811 - Erchonia Zerona® VZ8 K243811 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Erchonia Corporation. Cleared Jan 2025. https://www.510kdatabase.net/k243814/ 2025-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k243814-nuvasive-pulse-system-fda-510k.jpg K243814 - NuVasive Pulse System K243814 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k241273/ 2025-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k241273-fullfocus-fda-510k.jpg K241273 - FullFocus K241273 is a FDA 510(k) cleared pathology medical device. Manufacturer: Paige.Ai, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k242805/ 2025-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k242805-dental-cone-beam-computed-tomography-fda-510k.jpg K242805 - Dental Cone-beam Computed Tomography (FinScan F350) K242805 is a FDA 510(k) cleared radiology medical device. Manufacturer: Changzhou Finno Medical Technology Co., Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k240590/ 2025-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k240590-electrical-scooter-wt-t4su-fda-510k.jpg K240590 - Electrical Scooter, WT-T4SU K240590 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: W'U'S Tech Co., Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k241003/ 2025-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k241003-hiossen-pre-milled-abutment-et-pre-fda-510k.jpg K241003 - HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment) K241003 is a FDA 510(k) cleared dental medical device. Manufacturer: Hiossen, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k241489/ 2025-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k241489-remingel-fda-510k.jpg K241489 - ReminGel K241489 is a FDA 510(k) cleared dental medical device. Manufacturer: Inter-Med, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k241806/ 2025-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k241806-applied-biosystems-taqpath-covid-19-fda-510k.jpg K241806 - Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel K241806 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Life Technologies Corporation. Cleared Jan 2025. https://www.510kdatabase.net/k242043/ 2025-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k242043-sperm-freezing-medium-fda-510k.jpg K242043 - Sperm Freezing Medium K242043 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Gimbo Medical Technology Shenzhen Co., Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k242290/ 2025-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k242290-dormotech-nlab-fda-510k.jpg K242290 - DormoTech NLab K242290 is a FDA 510(k) cleared neurology medical device. Manufacturer: Dormotech Medical, Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k242661/ 2025-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k242661-tri-matrix-x-force-implants-fda-510k.jpg K242661 - TRI-matrix® X-Force Implants K242661 is a FDA 510(k) cleared dental medical device. Manufacturer: Tri Dental Implants Int. AG. Cleared Jan 2025. https://www.510kdatabase.net/k242741/ 2025-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k242741-ace-cannula-fda-510k.jpg K242741 - ACE Cannula K242741 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ace Medical Industry Co., Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k242842/ 2025-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k242842-anne-view-central-hub-fda-510k.jpg K242842 - ANNE View, Central Hub K242842 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sibel Health, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k243644/ 2025-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k243644-ceragem-automatic-thermal-massager-cgm-fda-510k.jpg K243644 - Ceragem Automatic Thermal Massager (CGM MB-2301 & CGM MB-2302) K243644 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Ceragem Co., Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k243813/ 2025-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k243813-qiastat-dx-gi-panel-2-mini-bv-fda-510k.jpg K243813 - QIAstat-Dx GI Panel 2 Mini B&V K243813 is a FDA 510(k) cleared microbiology medical device. Manufacturer: QIAGEN GmbH. Cleared Jan 2025. https://www.510kdatabase.net/k243818/ 2025-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k243818-nitrile-powder-free-examination-glove-fda-510k.jpg K243818 - Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) K243818 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hartalega NGC Sdn. Bhd.. Cleared Jan 2025. https://www.510kdatabase.net/k241079/ 2025-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k241079-uct-780-fda-510k.jpg K241079 - uCT 780 K241079 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k241456/ 2025-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k241456-glutenid-celiac-genetic-health-risk-test-fda-510k.jpg K241456 - GlutenID Celiac Genetic Health Risk Test K241456 is a FDA 510(k) cleared immunology medical device. Manufacturer: Targeted Genomics, LLC. Cleared Jan 2025. https://www.510kdatabase.net/k241808/ 2025-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k241808-apollohipx-thrss0001-fda-510k.jpg K241808 - ApolloHipX (THR.SS.0001) K241808 is a FDA 510(k) cleared radiology medical device. Manufacturer: Corin U.S.A. Limited. Cleared Jan 2025. https://www.510kdatabase.net/k242019/ 2025-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k242019-gxr-series-diagnostic-x-ray-system-fda-510k.jpg K242019 - GXR-Series Diagnostic X-Ray System K242019 is a FDA 510(k) cleared radiology medical device. Manufacturer: DRGEM Corporation. Cleared Jan 2025. https://www.510kdatabase.net/k242588/ 2025-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k242588-corepass-modular-microcatheter-flex-fda-510k.jpg K242588 - COREPASS Modular Microcatheter (FLEX) K242588 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: OrbusNeich Medical (Shenzhen) Co., Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k243259/ 2025-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k243259-masada-modular-spinal-fixation-system-fda-510k.jpg K243259 - MASADA Modular Spinal Fixation System K243259 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Astura Medical. Cleared Jan 2025. https://www.510kdatabase.net/k243335/ 2025-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k243335-vantage-galan-3t-mrt-3020-v100-with-fda-510k.jpg K243335 - Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR K243335 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Jan 2025. https://www.510kdatabase.net/k241904/ 2025-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k241904-dermisphere-dermal-template-fda-510k.jpg K241904 - DermiSphere Dermal Template K241904 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Fesariustherapeutics, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k242123/ 2025-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k242123-brainomix-360-e-cta-fda-510k.jpg K242123 - Brainomix 360 e-CTA K242123 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainomix Limited. Cleared Jan 2025. https://www.510kdatabase.net/k242139/ 2025-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k242139-mobility-scooter-yl-09b-yl-07-fda-510k.jpg K242139 - Mobility Scooter (YL-09B, YL-07) K242139 is a FDA 510(k) cleared neurology medical device. Manufacturer: Yongkang Yile Vehicle Co., Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k242488/ 2025-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k242488-soteria-e-view-fda-510k.jpg K242488 - Soteria E-View K242488 is a FDA 510(k) cleared radiology medical device. Manufacturer: Omega Medical Imaging, LLC. Cleared Jan 2025. https://www.510kdatabase.net/k242499/ 2025-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k242499-digital-radiography-x-ray-system-fda-510k.jpg K242499 - Digital Radiography X-ray System (SONTU100-RAD (E) , SONTU300-Mars (E)) K242499 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen?Sontu?Medical?Imaging?Equipment?Co., Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k242753/ 2025-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k242753-sd-tl-implant-system-fda-510k.jpg K242753 - SD TL Implant System K242753 is a FDA 510(k) cleared dental medical device. Manufacturer: Arum Dentistry Co., Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k242760/ 2025-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k242760-whill-model-r-fda-510k.jpg K242760 - WHILL Model R K242760 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Whill, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k243466/ 2025-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k243466-conformity-stem-extension-line-0-fda-510k.jpg K243466 - Conformity Stem Extension Line, #0 K243466 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: United Orthopedic Corporation. Cleared Jan 2025. https://www.510kdatabase.net/k243481/ 2025-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k243481-tmini-miniature-robotic-system-fda-510k.jpg K243481 - TMINI Miniature Robotic System K243481 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: THINK Surgical, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k233118/ 2025-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k233118-duet-v-model-esk-3261dv-fda-510k.jpg K233118 - DUET-V (Model: ESK-3261DV) K233118 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Eunsung Global Corp. Cleared Jan 2025. https://www.510kdatabase.net/k233419/ 2025-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k233419-gbr-system-fda-510k.jpg K233419 - GBR System K233419 is a FDA 510(k) cleared dental medical device. Manufacturer: Proimtech Saglik Urunleri Anonim Sirketi. Cleared Jan 2025. https://www.510kdatabase.net/k240346/ 2025-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k240346-nobelprocera-zirconia-implant-bridge-fda-510k.jpg K240346 - NobelProcera Zirconia Implant Bridge K240346 is a FDA 510(k) cleared dental medical device. Manufacturer: Nobel Biocare AB. Cleared Jan 2025. https://www.510kdatabase.net/k240984/ 2025-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k240984-i-stat-hs-tni-cartridge-with-the-i-fda-510k.jpg K240984 - i-STAT hs-TnI cartridge with the i-STAT 1 System K240984 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Point of Care, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k241283/ 2025-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k241283-elemental-granulate-fda-510k.jpg K241283 - Elemental Granulate K241283 is a FDA 510(k) cleared dental medical device. Manufacturer: Zinkh NV. Cleared Jan 2025. https://www.510kdatabase.net/k241350/ 2025-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k241350-clarify-dl-fda-510k.jpg K241350 - Clarify DL K241350 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems Israel, Functional Imaging. Cleared Jan 2025. https://www.510kdatabase.net/k241757/ 2025-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k241757-syngoct-dual-energy-fda-510k.jpg K241757 - syngo.CT Dual Energy K241757 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k242110/ 2025-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k242110-pentax-medical-video-colonoscope-ec38-fda-510k.jpg K242110 - PENTAX Medical Video Colonoscope (EC38-i20cWL) K242110 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Pentax of America, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k242119/ 2025-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k242119-innovision-exii-fda-510k.jpg K242119 - INNOVISION-EXII K242119 is a FDA 510(k) cleared radiology medical device. Manufacturer: Dk Medical System. Cleared Jan 2025. https://www.510kdatabase.net/k242578/ 2025-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k242578-evolve-nitric-oxide-delivery-system-fda-510k.jpg K242578 - EVOLVE Nitric Oxide Delivery System K242578 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Mallinckrodt Manufacturing, LLC. Cleared Jan 2025. https://www.510kdatabase.net/k242726/ 2025-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k242726-synapsys-vhit-fda-510k.jpg K242726 - Synapsys VHIT K242726 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Inventis S.R.L.. Cleared Jan 2025. https://www.510kdatabase.net/k243363/ 2025-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k243363-jlk-ich-fda-510k.jpg K243363 - JLK-ICH K243363 is a FDA 510(k) cleared radiology medical device. Manufacturer: JLK, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k243737/ 2025-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k243737-inbella-rf-system-fda-510k.jpg K243737 - Inbella RF System K243737 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Inbella Medical, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k250015/ 2025-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k250015-ormco-etchfree-bonding-system-ormco-fda-510k.jpg K250015 - Ormco™ EtchFree Bonding System, Ormco™ EtchFree Bonding Primer, Ormco™ EtchFree Adhesive K250015 is a FDA 510(k) cleared dental medical device. Manufacturer: Ormco Corporation. Cleared Jan 2025. https://www.510kdatabase.net/k241005/ 2025-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k241005-haemostasis-clips-fda-510k.jpg K241005 - Haemostasis Clips K241005 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Jiangxi Zhuoruihua Medical Instrument Co., Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k241388/ 2025-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k241388-rist-079-radial-access-guide-catheter-fda-510k.jpg K241388 - Rist 079 Radial Access Guide Catheter K241388 is a FDA 510(k) cleared neurology medical device. Manufacturer: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. Cleared Jan 2025. https://www.510kdatabase.net/k241568/ 2025-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k241568-crystlcare-pro-biorestorative-fluoride-fda-510k.jpg K241568 - CrystLCare™ PRO Biorestorative, Fluoride-Plus K241568 is a FDA 510(k) cleared dental medical device. Manufacturer: GreenMark Biomedical, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k241696/ 2025-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k241696-ortho-ai-fda-510k.jpg K241696 - Ortho AI K241696 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ortho Ai, LLC. Cleared Jan 2025. https://www.510kdatabase.net/k242326/ 2025-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k242326-wave-electrode-ae02-60-fda-510k.jpg K242326 - Wave Electrode (AE02-60) K242326 is a FDA 510(k) cleared neurology medical device. Manufacturer: Bionit Labs Srl. Cleared Jan 2025. https://www.510kdatabase.net/k242334/ 2025-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k242334-ezra-flash-fda-510k.jpg K242334 - Ezra Flash K242334 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ezra Ai, Inc.. Cleared Jan 2025. https://www.510kdatabase.net/k242448/ 2025-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k242448-power-wheelchair-d03-d05-d06-d09-d11-fda-510k.jpg K242448 - Power Wheelchair (D03, D05, D06, D09, D11, D16, D22, D23, D26, D36) K242448 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Anhui Jbh Medical Apparatus Co., Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k242789/ 2025-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k242789-bestqool-led-therapy-device-lmk-001lmk-fda-510k.jpg K242789 - Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006) K242789 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Dongguan Laiguang Electronic Technology Co., Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k243049/ 2025-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k243049-pulse-oximeter-fs20p-fda-510k.jpg K243049 - Pulse Oximeter (FS20P) K243049 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Hunan Accurate Bio-Medical Technology Co., Ltd.. Cleared Jan 2025. https://www.510kdatabase.net/k241338/ 2024-12-31 monthly 0.5 https://www.510kdatabase.net/og-image/k241338-peak-flow-meter-fda-510k.jpg K241338 - Peak Flow Meter K241338 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Chongqing Moffy Innovation Technology Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k241852/ 2024-12-31 monthly 0.5 https://www.510kdatabase.net/og-image/k241852-nasal-aspirator-ns-13-fda-510k.jpg K241852 - Nasal Aspirator (NS 13) K241852 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Avita Corporation. Cleared Dec 2024. https://www.510kdatabase.net/k242468/ 2024-12-31 monthly 0.5 https://www.510kdatabase.net/og-image/k242468-power-wheelchair-d10-d12-d15-d17-d20-d37-fda-510k.jpg K242468 - Power Wheelchair (D10, D12, D15, D17, D20, D37) K242468 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Anhui Jbh Medical Apparatus Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k242989/ 2024-12-31 monthly 0.5 https://www.510kdatabase.net/og-image/k242989-electric-wheelchair-model-h-fda-510k.jpg K242989 - Electric Wheelchair (MODEL H) K242989 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Nanjing E-Take Medical Apparatus Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k243224/ 2024-12-31 monthly 0.5 https://www.510kdatabase.net/og-image/k243224-mitraclip-g5-steerable-guide-catheter-fda-510k.jpg K243224 - MitraClip™ G5 Steerable Guide Catheter (SGC0801) K243224 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared Dec 2024. https://www.510kdatabase.net/k243225/ 2024-12-31 monthly 0.5 https://www.510kdatabase.net/og-image/k243225-nasal-pillow-mask-small-nnpm-01-nefes-s-fda-510k.jpg K243225 - Nasal Pillow Mask - Small (NNPM-01/ Nefes S) K243225 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Genadyne Biotechnologies, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k243670/ 2024-12-31 monthly 0.5 https://www.510kdatabase.net/og-image/k243670-idys-lif-fda-510k.jpg K243670 - Idys® LIF K243670 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Clariance. Cleared Dec 2024. https://www.510kdatabase.net/k242376/ 2024-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k242376-next-generation-access-platform-fda-510k.jpg K242376 - Next Generation Access Platform K242376 is a FDA 510(k) cleared neurology medical device. Manufacturer: Balt USA, LLC. Cleared Dec 2024. https://www.510kdatabase.net/k242804/ 2024-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k242804-pal-aspiration-system-fda-510k.jpg K242804 - PAL Aspiration System K242804 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Microaire Surgical Instruments, LLC. Cleared Dec 2024. https://www.510kdatabase.net/k243394/ 2024-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k243394-af531-oro-nasal-se-face-mask-fda-510k.jpg K243394 - AF531 Oro-Nasal SE Face Mask K243394 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k243445/ 2024-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k243445-splendor-x-alex-alex2-ndyag-alexndyag-fda-510k.jpg K243445 - Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG) K243445 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bios S.R.L.. Cleared Dec 2024. https://www.510kdatabase.net/k233119/ 2024-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k233119-8mp-color-lcd-displays-c811w-c811wt-fda-510k.jpg K233119 - 8MP Color LCD Displays C811W, C811WT, PA27 and PA27T K233119 is a FDA 510(k) cleared pathology medical device. Manufacturer: Shenzhen Beacon Display Technology Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k240828/ 2024-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k240828-oec-one-asd-fda-510k.jpg K240828 - OEC One ASD K240828 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Hualun Medical Systems Co. , Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k241127/ 2024-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k241127-inno-sla-mini-plus-implant-system-fda-510k.jpg K241127 - INNO SLA Mini Plus® Implant System K241127 is a FDA 510(k) cleared dental medical device. Manufacturer: Cowellmedi Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k241924/ 2024-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k241924-elastic-impression-material-fda-510k.jpg K241924 - Elastic Impression Material K241924 is a FDA 510(k) cleared dental medical device. Manufacturer: Beijing Okvd Biological Technology , Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k241972/ 2024-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k241972-bluediamond-implant-fda-510k.jpg K241972 - BLUEDIAMOND IMPLANT K241972 is a FDA 510(k) cleared dental medical device. Manufacturer: Megagen Implant Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k242252/ 2024-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k242252-power-wheelchair-fda-510k.jpg K242252 - Power Wheelchair K242252 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Anhui Jbh Medical Apparatus Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k242480/ 2024-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k242480-flash-evd-system-10-0002-fda-510k.jpg K242480 - FLASH EVD System (10-0002) K242480 is a FDA 510(k) cleared neurology medical device. Manufacturer: 7D Surgical ULC. Cleared Dec 2024. https://www.510kdatabase.net/k243084/ 2024-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k243084-biotraceio-precision-20-fda-510k.jpg K243084 - BioTraceIO Precision (2.0) K243084 is a FDA 510(k) cleared radiology medical device. Manufacturer: Techsomed Medical Technologies , Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k243835/ 2024-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k243835-tilink-p-si-joint-fusion-system-fda-510k.jpg K243835 - TiLink-P SI Joint Fusion System K243835 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SurGenTec, LLC. Cleared Dec 2024. https://www.510kdatabase.net/k232966/ 2024-12-26 monthly 0.5 https://www.510kdatabase.net/og-image/k232966-fisiowarm-70-fda-510k.jpg K232966 - FISIOWARM 7.0 K232966 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Golden Star Srl. Cleared Dec 2024. https://www.510kdatabase.net/k233252/ 2024-12-26 monthly 0.5 https://www.510kdatabase.net/og-image/k233252-straumann-cares-visual-and-nova-dental-fda-510k.jpg K233252 - Straumann CARES Visual and Nova Dental CAD K233252 is a FDA 510(k) cleared dental medical device. Manufacturer: Institut Straumann AG. Cleared Dec 2024. https://www.510kdatabase.net/k240517/ 2024-12-26 monthly 0.5 https://www.510kdatabase.net/og-image/k240517-proseal-vented-universal-vial-adaptor-fda-510k.jpg K240517 - ProSeal™ Vented Universal Vial Adaptor K240517 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Epic Medical Pte. , Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k243037/ 2024-12-26 monthly 0.5 https://www.510kdatabase.net/og-image/k243037-diode-laser-system-model-dawn-s-fda-510k.jpg K243037 - Diode Laser System model Dawn-S K243037 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd. Cleared Dec 2024. https://www.510kdatabase.net/k243097/ 2024-12-26 monthly 0.5 https://www.510kdatabase.net/og-image/k243097-rm-star-ex-with-rms-needle-fda-510k.jpg K243097 - RM STAR EX with RMS Needle K243097 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bomtech Electronics Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k243141/ 2024-12-26 monthly 0.5 https://www.510kdatabase.net/og-image/k243141-diode-laser-system-laserpro-d-980-fda-510k.jpg K243141 - Diode Laser System (LaserPro D 980) K243141 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Jiangxi Medex Technology Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k243658/ 2024-12-26 monthly 0.5 https://www.510kdatabase.net/og-image/k243658-tmc-compression-implant-system-fda-510k.jpg K243658 - TMC Compression Implant System K243658 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Treace Medical Concepts. Cleared Dec 2024. https://www.510kdatabase.net/k243677/ 2024-12-26 monthly 0.5 https://www.510kdatabase.net/og-image/k243677-iovera-system-fda-510k.jpg K243677 - iovera° System K243677 is a FDA 510(k) cleared neurology medical device. Manufacturer: Pacira Biosciences, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k242434/ 2024-12-24 monthly 0.5 https://www.510kdatabase.net/og-image/k242434-insulin-syringes-fda-510k.jpg K242434 - Insulin Syringes K242434 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Chirana T. Injecta. Cleared Dec 2024. https://www.510kdatabase.net/k243623/ 2024-12-24 monthly 0.5 https://www.510kdatabase.net/og-image/k243623-spinear-snap-syncar-spine-fda-510k.jpg K243623 - SpineAR SNAP (SyncAR Spine) K243623 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Surgical Theater, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k233614/ 2024-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k233614-genadyne-duo-npwt-fda-510k.jpg K233614 - Genadyne DUO NPWT K233614 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Genadyne Biotechnologies, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k240890/ 2024-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k240890-panopticai-vital-signs-fda-510k.jpg K240890 - PanopticAI Vital Signs K240890 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: PanopticAI technologies Limited. Cleared Dec 2024. https://www.510kdatabase.net/k240975/ 2024-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k240975-electrosurgical-generator-es-100-fda-510k.jpg K240975 - Electrosurgical Generator (ES-100) K240975 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Beijing Taktvoll Technology Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k241091/ 2024-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k241091-simeox-200-airway-clearance-device-fda-510k.jpg K241091 - SIMEOX 200 Airway Clearance Device K241091 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Inogen, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k241288/ 2024-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k241288-noxturnal-web-fda-510k.jpg K241288 - Noxturnal Web K241288 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nox Medical Ehf. Cleared Dec 2024. https://www.510kdatabase.net/k241856/ 2024-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k241856-sofjec-single-use-needle-fda-510k.jpg K241856 - Sofjec (Single use Needle) K241856 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hlb Lifescience Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k242091/ 2024-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k242091-bolo-button-system-fda-510k.jpg K242091 - Bolo Button System K242091 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Fusion Orthopedics. Cleared Dec 2024. https://www.510kdatabase.net/k242143/ 2024-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k242143-angiography-injector-fda-510k.jpg K242143 - Angiography Injector K242143 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shandong Int Medical Instruments Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k242403/ 2024-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k242403-aquilion-one-tsx-308a3-v15-fda-510k.jpg K242403 - Aquilion ONE (TSX-308A/3) V1.5 K242403 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Dec 2024. https://www.510kdatabase.net/k242573/ 2024-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k242573-nido-baby-magnetic-resonance-imaging-fda-510k.jpg K242573 - NIDO Baby Magnetic Resonance Imaging System K242573 is a FDA 510(k) cleared radiology medical device. Manufacturer: Jiangsu Lici Medical Device Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k242735/ 2024-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k242735-belmont-rapid-infuser-ri-2-rapid-fda-510k.jpg K242735 - Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min) K242735 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Belmont Medical Technologies. Cleared Dec 2024. https://www.510kdatabase.net/k242782/ 2024-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k242782-glassbone-granules-fda-510k.jpg K242782 - GlassBone Granules K242782 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Noraker. Cleared Dec 2024. https://www.510kdatabase.net/k242797/ 2024-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k242797-osteoflo-hydrofiber-fda-510k.jpg K242797 - OsteoFlo HydroFiber K242797 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SurGenTec, LLC. Cleared Dec 2024. https://www.510kdatabase.net/k242939/ 2024-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k242939-artfx-trauma-bone-plate-and-screw-system-fda-510k.jpg K242939 - ARTFX Trauma Bone Plate and Screw System K242939 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Artfx Medical. Cleared Dec 2024. https://www.510kdatabase.net/k242948/ 2024-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k242948-adora-drfi-04550010-fda-510k.jpg K242948 - Adora DRFi (04550010) K242948 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nrt X-Ray A/S. Cleared Dec 2024. https://www.510kdatabase.net/k243103/ 2024-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k243103-denture-base-fda-510k.jpg K243103 - Denture Base K243103 is a FDA 510(k) cleared dental medical device. Manufacturer: Riton 3D Technology Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k243177/ 2024-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k243177-sacs-pro-fda-510k.jpg K243177 - SACS PRO K243177 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Elastimed , Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k243248/ 2024-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k243248-inhance-intact-fda-510k.jpg K243248 - INHANCE INTACT™ K243248 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Ireland UC. Cleared Dec 2024. https://www.510kdatabase.net/k243693/ 2024-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k243693-neo-pedicle-screw-system-fda-510k.jpg K243693 - NEO Pedicle Screw System™ K243693 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Neo Medical SA. Cleared Dec 2024. https://www.510kdatabase.net/k243121/ 2024-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k243121-slt-select-fiber-delivery-system-and-fda-510k.jpg K243121 - SLT Select Fiber Delivery System and Contact Tips (models: SSRH 8-SMA K243121 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Jiangxi Medex Technology Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k243085/ 2024-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k243085-ipl-hair-removal-device-de03a-w-de03a-fda-510k.jpg K243085 - IPL Hair Removal Device (DE03A-W, DE03A-P, DE03A-V, DE03A-G, DE03B-W, DE03B-P, DE03B-V, DE03B-G) K243085 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Zhuzhou Goldenhot Medical Technology Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k243147/ 2024-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k243147-lgo-surgical-laser-fibers-fda-510k.jpg K243147 - LGO-Surgical Laser Fibers K243147 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Light Guide Optics International , Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k233639/ 2024-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k233639-smartclip-secure-soft-tissue-marker-fda-510k.jpg K233639 - SmartClip Secure Soft Tissue Marker K233639 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Elucent Medical, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k240435/ 2024-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k240435-alpha-dent-implants-dental-implants-fda-510k.jpg K240435 - Alpha Dent Implants Dental Implants System K240435 is a FDA 510(k) cleared dental medical device. Manufacturer: Alpha Dent Implants GmbH. Cleared Dec 2024. https://www.510kdatabase.net/k241167/ 2024-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k241167-biosphere-putty-fda-510k.jpg K241167 - BioSphere Putty K241167 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synergy Biomedical. Cleared Dec 2024. https://www.510kdatabase.net/k241394/ 2024-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k241394-ihealth-early-pregnancy-test-fda-510k.jpg K241394 - iHealth® Early Pregnancy Test K241394 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Andon Health Co, Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k241411/ 2024-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k241411-welch-allyn-connex-spot-monitor-fda-510k.jpg K241411 - Welch Allyn Connex® Spot Monitor K241411 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Welch Allyn, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k241652/ 2024-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k241652-dash-sars-cov-2-flu-ab-test-fda-510k.jpg K241652 - DASH® SARS-CoV-2 & Flu A/B Test K241652 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Nuclein, LLC. Cleared Dec 2024. https://www.510kdatabase.net/k241670/ 2024-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k241670-fractional-co2-laser-therapy-system-fda-510k.jpg K241670 - Fractional CO2 Laser Therapy System (FG900-S) K241670 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Beijing Adss Development Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k241680/ 2024-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k241680-momcozy-wearable-breast-pump-bp311-fda-510k.jpg K241680 - Momcozy Wearable Breast Pump (BP311) K241680 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shenzhen Root Innovation Technology Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k241888/ 2024-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k241888-single-use-balloon-dilatation-catheter-fda-510k.jpg K241888 - Single-use Balloon Dilatation Catheter K241888 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Leo Medical Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k242168/ 2024-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k242168-voluson-expert-18-fda-510k.jpg K242168 - Voluson Expert 18 K242168 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared Dec 2024. https://www.510kdatabase.net/k242281/ 2024-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k242281-arrow-endurance-extended-dwell-fda-510k.jpg K242281 - Arrow Endurance Extended Dwell Peripheral Catheter System (EDC-00620) K242281 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Arrow International, LLC (A subsidiary of Teleflex, Inc.). Cleared Dec 2024. https://www.510kdatabase.net/k242362/ 2024-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k242362-lightning-viewer-fda-510k.jpg K242362 - Lightning Viewer K242362 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nexsys Electronics Inc. Dba Medweb. Cleared Dec 2024. https://www.510kdatabase.net/k242529/ 2024-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k242529-tigon-medical-all-suture-anchors-asa-fda-510k.jpg K242529 - Tigon Medical All-Suture Anchors (ASA) K242529 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tigon Medical. Cleared Dec 2024. https://www.510kdatabase.net/k242530/ 2024-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k242530-hf-etchant-hydrofluoric-acid-etching-gel-fda-510k.jpg K242530 - HF-Etchant Hydrofluoric Acid Etching Gel K242530 is a FDA 510(k) cleared dental medical device. Manufacturer: Rizhao Huge Biomaterials Company, Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k242534/ 2024-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k242534-handpico-fractional-laser-handpiece-tip-fda-510k.jpg K242534 - HandPICO Fractional Laser Handpiece Tip K242534 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Vydence Medical. Cleared Dec 2024. https://www.510kdatabase.net/k242572/ 2024-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k242572-topcem-try-in-veneer-try-in-gel-fda-510k.jpg K242572 - TopCEM-Try in Veneer Try-in Gel K242572 is a FDA 510(k) cleared dental medical device. Manufacturer: Rizhao Huge Biomaterials Company, Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k242599/ 2024-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k242599-aprevo-digital-planning-fda-510k.jpg K242599 - aprevo® Digital Planning K242599 is a FDA 510(k) cleared radiology medical device. Manufacturer: Carlsmed, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k242628/ 2024-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k242628-scooter-ps30-fda-510k.jpg K242628 - Scooter (PS30) K242628 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Lichtmega Technology Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k242644/ 2024-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k242644-sendero-max-delivery-catheter-fda-510k.jpg K242644 - SENDERO MAX Delivery Catheter K242644 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Okami Medical, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k242688/ 2024-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k242688-finiff-system-fda-510k.jpg K242688 - Finiff System K242688 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Skingrab Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k242923/ 2024-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k242923-simplesnip-endoscopic-suture-cutter-fda-510k.jpg K242923 - SimpleSnip Endoscopic Suture Cutter (SC500160) K242923 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Envision Endoscopy. Cleared Dec 2024. https://www.510kdatabase.net/k242929/ 2024-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k242929-fas-aligner-system-fda-510k.jpg K242929 - Fas Aligner System K242929 is a FDA 510(k) cleared dental medical device. Manufacturer: Xplora 3D Europe S.L. Cleared Dec 2024. https://www.510kdatabase.net/k242953/ 2024-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k242953-kids-arterial-filters-fda-510k.jpg K242953 - KIDS Arterial Filters K242953 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sorin Group Italia S.R.L.. Cleared Dec 2024. https://www.510kdatabase.net/k243024/ 2024-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k243024-cellbrick-knee-spacer-fda-510k.jpg K243024 - Cellbrick Knee Spacer K243024 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: United Orthopedic Corporation. Cleared Dec 2024. https://www.510kdatabase.net/k243040/ 2024-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k243040-led-light-therapy-mask-skb-1818pskb-fda-510k.jpg K243040 - LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418) K243040 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Siken 3D Technology Development Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k243149/ 2024-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k243149-microliter-dosing-syringe-9-20-25-375-fda-510k.jpg K243149 - Microliter Dosing Syringe (9, 20, 25, 37.5, 50 and 100 microliter models) K243149 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Congruence Medical Solutions, LLC. Cleared Dec 2024. https://www.510kdatabase.net/k243293/ 2024-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k243293-zimmer-persona-personalized-knee-system-fda-510k.jpg K243293 - Zimmer® Persona® Personalized Knee System K243293 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer Biomet. Cleared Dec 2024. https://www.510kdatabase.net/k243308/ 2024-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k243308-bonebridge-osteosynthesis-plating-fda-510k.jpg K243308 - Bonebridge Osteosynthesis Plating System (SALGINA 2.5mm Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, LEPORELLO 3.5mm Olecranon Syste) K243308 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Bonebridge AG. Cleared Dec 2024. https://www.510kdatabase.net/k243607/ 2024-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k243607-moda-flx-hemodialysis-system-cartridge-fda-510k.jpg K243607 - Moda-flx Hemodialysis System™ Cartridge (102121-001 ) K243607 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Diality, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k243629/ 2024-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k243629-momcozy-wearable-breast-pump-bp311-fda-510k.jpg K243629 - Momcozy Wearable Breast Pump (BP311) K243629 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shenzhen Root Innovation Technology Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k243671/ 2024-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k243671-excelsiusgps-instruments-fda-510k.jpg K243671 - ExcelsiusGPS® Instruments K243671 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k243675/ 2024-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k243675-inkspace-imaging-small-body-array-fda-510k.jpg K243675 - InkSpace Imaging Small Body Array K243675 is a FDA 510(k) cleared radiology medical device. Manufacturer: Inkspace Imaging, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k243759/ 2024-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k243759-biofire-blood-culture-identification-2-fda-510k.jpg K243759 - BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack)) K243759 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Biofire Diagnostics, LLC. Cleared Dec 2024. https://www.510kdatabase.net/k243911/ 2024-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k243911-hpr-cordless-hygiene-handpiece-fda-510k.jpg K243911 - HPR Cordless Hygiene Handpiece K243911 is a FDA 510(k) cleared dental medical device. Manufacturer: Handpiece Headquarters. Cleared Dec 2024. https://www.510kdatabase.net/k232813/ 2024-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k232813-therapy-ec-therapy-xt-fda-510k.jpg K232813 - Therapy EC, Therapy XT K232813 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Dmc Importacao E Exportacao DE Equipamentos Ltda. Cleared Dec 2024. https://www.510kdatabase.net/k240348/ 2024-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k240348-quantum-mitohormesis-qmt-m2101-fda-510k.jpg K240348 - Quantum Mitohormesis (QMT) (M2101) K240348 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Quantumtx Pte. , Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k240885/ 2024-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k240885-shadow-catheter-fda-510k.jpg K240885 - Shadow Catheter K240885 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Simpson Interventions, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k241168/ 2024-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k241168-system-83-revolve-endoscope-fda-510k.jpg K241168 - System 83 Revolve Endoscope Washer/Disinfector K241168 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wassenburg Medical, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k241322/ 2024-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k241322-electric-breast-pump-ld-208l-ld-3010l-fda-510k.jpg K241322 - Electric Breast Pump (LD-208L, LD-3010L, LD-2010L, LD-3010, LD-2010) K241322 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Joytech Healthcare Co. , Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k241637/ 2024-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k241637-echo-intracranial-base-catheter-fda-510k.jpg K241637 - Echo Intracranial Base Catheter K241637 is a FDA 510(k) cleared neurology medical device. Manufacturer: Stryker Neurovascular. Cleared Dec 2024. https://www.510kdatabase.net/k241768/ 2024-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k241768-broadway-8-catheter-fda-510k.jpg K241768 - Broadway 8 Catheter K241768 is a FDA 510(k) cleared neurology medical device. Manufacturer: Stryker Neurovascular. Cleared Dec 2024. https://www.510kdatabase.net/k241778/ 2024-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k241778-hudson-rci-comfort-flo-cubcannula-fda-510k.jpg K241778 - Hudson RCI Comfort Flo® CubCannula™ K241778 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Medline Industries, LP. Cleared Dec 2024. https://www.510kdatabase.net/k242063/ 2024-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k242063-libairty-airway-clearance-system-fda-510k.jpg K242063 - LibAirty Airway Clearance System K242063 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Synchrony Medical , Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k242270/ 2024-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k242270-orthonext-platform-system-fda-510k.jpg K242270 - OrthoNext Platform System K242270 is a FDA 510(k) cleared radiology medical device. Manufacturer: Orthofix Srl. Cleared Dec 2024. https://www.510kdatabase.net/k242370/ 2024-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k242370-medline-microdissection-needle-4cm-fda-510k.jpg K242370 - Medline Microdissection Needle (4cm) (140936 (ESE104A)) K242370 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medline Industries, LP. Cleared Dec 2024. https://www.510kdatabase.net/k242467/ 2024-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k242467-iq-uip-fda-510k.jpg K242467 - IQ-UIP K242467 is a FDA 510(k) cleared radiology medical device. Manufacturer: Imbio, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k242700/ 2024-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k242700-radiant-renewal-skincare-lid-hd-59a-hd-fda-510k.jpg K242700 - Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A, HD-73A, HD-73B, HD-116, HD-116A, HD-53A, HD-53B) K242700 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Nuon Medical Equipment Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k242819/ 2024-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k242819-ipd-dental-implant-abutments-fda-510k.jpg K242819 - IPD Dental Implant Abutments K242819 is a FDA 510(k) cleared dental medical device. Manufacturer: Implant Protesis Dental 2004, S.L.. Cleared Dec 2024. https://www.510kdatabase.net/k242892/ 2024-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k242892-cristaline-aligners-z-flx-fda-510k.jpg K242892 - Cristaline Aligners Z FLX K242892 is a FDA 510(k) cleared dental medical device. Manufacturer: Cristaline Aligners GmbH. Cleared Dec 2024. https://www.510kdatabase.net/k242908/ 2024-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k242908-uv-phototherapy-device-group-a-fda-510k.jpg K242908 - UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD) K242908 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shanghai Sigma High-Tech Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k242954/ 2024-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k242954-integrity-v500-integrity-integrity-fda-510k.jpg K242954 - Integrity V500 (Integrity, Integrity with VEMP) K242954 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Vivosonic, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k243071/ 2024-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k243071-bovine-dermis-collagen-dermal-matrix-fda-510k.jpg K243071 - Bovine Dermis Collagen Dermal Matrix K243071 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Collagen Matrix, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k243094/ 2024-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k243094-quickdent-dental-implant-system-fda-510k.jpg K243094 - Quickdent Dental Implant System K243094 is a FDA 510(k) cleared dental medical device. Manufacturer: Quickdent Devices Private , Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k243169/ 2024-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k243169-the-sensititre-18-24-hour-mic-or-fda-510k.jpg K243169 - The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL K243169 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Thermo Fisher Scientific. Cleared Dec 2024. https://www.510kdatabase.net/k243171/ 2024-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k243171-yushan-x-ray-flat-panel-detector-fda-510k.jpg K243171 - Yushan X-Ray Flat Panel Detector K243171 is a FDA 510(k) cleared radiology medical device. Manufacturer: Innocare Optoelectronics Corp.. Cleared Dec 2024. https://www.510kdatabase.net/k243361/ 2024-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k243361-nutrifit-fda-510k.jpg K243361 - Nutrifit K243361 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Vygon USA. Cleared Dec 2024. https://www.510kdatabase.net/k243430/ 2024-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k243430-micro-current-facial-beauty-device-am-fda-510k.jpg K243430 - Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) K243430 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Aozemei Technology Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k243440/ 2024-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k243440-electric-wheelchair-hc820n-fda-510k.jpg K243440 - Electric Wheelchair (HC820N) K243440 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Yongkang Hengyi Vehicle Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k243595/ 2024-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k243595-ovitex-prs-long-term-resorbable-fda-510k.jpg K243595 - OviTex PRS (Long-Term Resorbable) K243595 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: TELA Bio, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k243652/ 2024-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k243652-monoject-enteral-syringe-with-enfit-fda-510k.jpg K243652 - Monoject™ Enteral Syringe with ENFit Connector (401SE) K243652 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cardinalhealth. Cleared Dec 2024. https://www.510kdatabase.net/k243688/ 2024-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k243688-saige-dx-310-fda-510k.jpg K243688 - Saige-Dx (3.1.0) K243688 is a FDA 510(k) cleared radiology medical device. Manufacturer: DeepHealth, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k243705/ 2024-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k243705-saige-density-250-fda-510k.jpg K243705 - Saige-Density (2.5.0) K243705 is a FDA 510(k) cleared radiology medical device. Manufacturer: DeepHealth, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k243725/ 2024-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k243725-bd-vaginal-panel-fda-510k.jpg K243725 - BD Vaginal Panel K243725 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson and Company. Cleared Dec 2024. https://www.510kdatabase.net/den240014/ 2024-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/den240014-arc-ex-system-fda-510k.jpg DEN240014 - ARC-EX System DEN240014 is a FDA 510(k) cleared neurology medical device. Manufacturer: Onward Medical, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k240763/ 2024-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k240763-firstfit-surgical-kit-fda-510k.jpg K240763 - FirstFit Surgical Kit K240763 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Freudenberg Medical, LLC. Cleared Dec 2024. https://www.510kdatabase.net/k240765/ 2024-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k240765-porous-biologic-scaffold-fda-510k.jpg K240765 - Porous Biologic Scaffold K240765 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ventris Medical. Cleared Dec 2024. https://www.510kdatabase.net/k240959/ 2024-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k240959-respiratory-muscle-trainer-fda-510k.jpg K240959 - Respiratory Muscle Trainer K240959 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Chongqing Moffy Innovation Technology Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k241040/ 2024-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k241040-amethyst-hp-pta-otw-0035-catheter-fda-510k.jpg K241040 - Amethyst HP PTA OTW 0.035 Catheter K241040 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Natec Medical , Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k241058/ 2024-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k241058-lyka-port-needle-free-access-device-fda-510k.jpg K241058 - Lyka® PORT Needle Free Access Device (4170Y) K241058 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Quest Medical, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k241095/ 2024-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k241095-artsmedia-semen-wash-medium-fda-510k.jpg K241095 - ARTSMedia Semen Wash Medium K241095 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Artsmedia Denmark Aps. Cleared Dec 2024. https://www.510kdatabase.net/k241132/ 2024-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k241132-artsmedia-oocyte-aspiration-medium-fda-510k.jpg K241132 - ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100) K241132 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Artsmedia Denmark Aps. Cleared Dec 2024. https://www.510kdatabase.net/k241395/ 2024-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k241395-active-system-fda-510k.jpg K241395 - Active System K241395 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Caerus Corporation. Cleared Dec 2024. https://www.510kdatabase.net/k242216/ 2024-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k242216-gentafix-1-3-3mv-fda-510k.jpg K242216 - GENTAFIX® (1, 3, 3MV) K242216 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Teknimed Sas. Cleared Dec 2024. https://www.510kdatabase.net/k242424/ 2024-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k242424-bluebird-single-use-respiratory-effort-fda-510k.jpg K242424 - Bluebird Single-Use Respiratory Effort Belt K242424 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Cadwell Industries, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k242535/ 2024-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k242535-single-use-flexible-cystoscope-cy-fda-510k.jpg K242535 - Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01, CY-E2G01R, CY-S2E01, CY-S2E01R) K242535 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hunan Vathin Medical Instrument Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k242662/ 2024-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k242662-falconxpress-falconxpress-fda-510k.jpg K242662 - Falcon/Xpress (Falcon/Xpress) K242662 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Viasonix , Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k242787/ 2024-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k242787-tens-ems-device-tu1080-fda-510k.jpg K242787 - Tens & Ems Device (TU1080) K242787 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Changsha Anxiang Medical Technology Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k243128/ 2024-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k243128-klockner-kits-fda-510k.jpg K243128 - Klockner Kits K243128 is a FDA 510(k) cleared general hospital medical device. Manufacturer: SOADCO, S.L.. Cleared Dec 2024. https://www.510kdatabase.net/k243609/ 2024-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k243609-equivabone-osteoinductive-bone-graft-fda-510k.jpg K243609 - EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone ) K243609 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Etex Corporation. Cleared Dec 2024. https://www.510kdatabase.net/k243615/ 2024-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k243615-physica-porous-femoral-components-fda-510k.jpg K243615 - Physica Porous Femoral Components K243615 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Lima Corporate S.P.A.. Cleared Dec 2024. https://www.510kdatabase.net/k243625/ 2024-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k243625-xpert-mrsasa-ssti-fda-510k.jpg K243625 - Xpert MRSA/SA SSTI K243625 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Cepheid. Cleared Dec 2024. https://www.510kdatabase.net/k243720/ 2024-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k243720-3delta-unlimited-fda-510k.jpg K243720 - 3Delta UNlimited K243720 is a FDA 510(k) cleared dental medical device. Manufacturer: Deltamed GmbH. Cleared Dec 2024. https://www.510kdatabase.net/k223093/ 2024-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k223093-aptiva-aps-igg-reagent-fda-510k.jpg K223093 - Aptiva APS IgG Reagent K223093 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k240798/ 2024-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k240798-cntrl-bladder-support-pessary-fda-510k.jpg K240798 - Cntrl+ Bladder Support Pessary K240798 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cntrl+, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k241036/ 2024-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k241036-autoclave-indicator-tape-fda-510k.jpg K241036 - Autoclave Indicator Tape K241036 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangmen New Era External Use Drug Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k241556/ 2024-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k241556-cardiac-workstation-5000-fda-510k.jpg K241556 - Cardiac Workstation (5000) K241556 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Philips Medizin Systeme B?blingen GmbH. Cleared Dec 2024. https://www.510kdatabase.net/k241616/ 2024-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k241616-allonus-tech-prosthetics-fda-510k.jpg K241616 - ALLONUS Tech Prosthetics K241616 is a FDA 510(k) cleared dental medical device. Manufacturer: Allonus Tech Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k241801/ 2024-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k241801-tornus-es-fda-510k.jpg K241801 - Tornus ES K241801 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Asahi Intecc Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k242146/ 2024-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k242146-biobrane-temporary-wound-dressing-fda-510k.jpg K242146 - BIOBRANE Temporary Wound Dressing K242146 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew Medical Limited. Cleared Dec 2024. https://www.510kdatabase.net/k242297/ 2024-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k242297-reform-pedicle-screw-system-fda-510k.jpg K242297 - Reform Pedicle Screw System K242297 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Precision Spine, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k242413/ 2024-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k242413-vizionfocus-mififilcon-a-silicone-fda-510k.jpg K242413 - VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens K242413 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Vizionfocus, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k242558/ 2024-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k242558-halyard-black-nitrile-powder-free-exam-fda-510k.jpg K242558 - Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid K242558 is a FDA 510(k) cleared general hospital medical device. Manufacturer: O&M Halyard, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k242783/ 2024-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k242783-roche-digital-pathology-dx-fda-510k.jpg K242783 - Roche Digital Pathology Dx K242783 is a FDA 510(k) cleared pathology medical device. Manufacturer: Ventana Medical Systems, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k242815/ 2024-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k242815-pocket-tens-ep-300-fda-510k.jpg K242815 - POCKET TENS (EP-300) K242815 is a FDA 510(k) cleared neurology medical device. Manufacturer: Hivox Biotek, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k242816/ 2024-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k242816-quantium-fda-510k.jpg K242816 - Quantium K242816 is a FDA 510(k) cleared dental medical device. Manufacturer: Bisco, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k242869/ 2024-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k242869-prodisc-l-instruments-fda-510k.jpg K242869 - prodisc® L Instruments K242869 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Centinel Spine, LLC. Cleared Dec 2024. https://www.510kdatabase.net/k242987/ 2024-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k242987-thulium-fiber-laser-fiberlaze-fiberlaze-fda-510k.jpg K242987 - Thulium Fiber Laser (FiberLAZE+, FiberLAZE) K242987 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Allengers Global Healthcare Private Limited. Cleared Dec 2024. https://www.510kdatabase.net/k243336/ 2024-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k243336-lucitone-digital-print-denture-system-fda-510k.jpg K243336 - Lucitone Digital Print Denture™ System K243336 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k243365/ 2024-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k243365-healgen-accurate-muti-drug-urine-drug-fda-510k.jpg K243365 - Healgen Accurate Muti-Drug Urine Drug Screen Cup K243365 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Healgen Scientific, LLC. Cleared Dec 2024. https://www.510kdatabase.net/k243664/ 2024-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k243664-sentinel-camera-fda-510k.jpg K243664 - Sentinel Camera K243664 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Ai Optics. Cleared Dec 2024. https://www.510kdatabase.net/k232839/ 2024-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k232839-eye-secret-38-uv-aspheric-polymacon-fda-510k.jpg K232839 - Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear K232839 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Yung Sheng Optical Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k240676/ 2024-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k240676-ultimus-series-ultrasound-diagnostic-fda-510k.jpg K240676 - ULTIMUS Series Ultrasound Diagnostic System K240676 is a FDA 510(k) cleared radiology medical device. Manufacturer: Vinno Technology (Suzhou) Co.,Ltd. Cleared Dec 2024. https://www.510kdatabase.net/k240793/ 2024-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k240793-mskai-fda-510k.jpg K240793 - MSKai K240793 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mskai. Cleared Dec 2024. https://www.510kdatabase.net/k240809/ 2024-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k240809-luofucon-silver-collagen-dressing-fda-510k.jpg K240809 - LUOFUCON® Silver Collagen Dressing K240809 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Huizhou Foryou Medical Devices Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k240873/ 2024-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k240873-tembo-embolic-system-fda-510k.jpg K240873 - TEMBO Embolic System K240873 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Instylla, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k240937/ 2024-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k240937-aim-na-fda-510k.jpg K240937 - AIM (N/A) K240937 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Inventeur, LLC. Cleared Dec 2024. https://www.510kdatabase.net/k242003/ 2024-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k242003-xabo-ventricular-catheter-xabo-fda-510k.jpg K242003 - XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set K242003 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k242015/ 2024-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k242015-topaz-mobile-x-ray-system-models-topaz-fda-510k.jpg K242015 - TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D) K242015 is a FDA 510(k) cleared radiology medical device. Manufacturer: DRGEM Corporation. Cleared Dec 2024. https://www.510kdatabase.net/k242307/ 2024-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k242307-achieve-partial-knee-system-fda-510k.jpg K242307 - ACHIEVE Partial Knee System K242307 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ignite Orthomotion. Cleared Dec 2024. https://www.510kdatabase.net/k243066/ 2024-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k243066-dental-implants-and-abutments-fda-510k.jpg K243066 - Dental Implants and Abutments K243066 is a FDA 510(k) cleared dental medical device. Manufacturer: Ditron Dental, Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k243471/ 2024-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k243471-extraction-basket-fda-510k.jpg K243471 - Extraction Basket K243471 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Micro-Tech (Nanjing) Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k243641/ 2024-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k243641-da-vinci-surgical-system-is5000-fda-510k.jpg K243641 - da Vinci Surgical System (IS5000) K243641 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k242124/ 2024-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k242124-simsize-fda-510k.jpg K242124 - Sim&Size K242124 is a FDA 510(k) cleared neurology medical device. Manufacturer: Sim&Cure. Cleared Dec 2024. https://www.510kdatabase.net/k231424/ 2024-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k231424-heartbeam-aimigotm-system-fda-510k.jpg K231424 - HeartBeam AIMIGo(TM) System K231424 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Heartbeam, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k233001/ 2024-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k233001-bioscope-neuromonitor-device-fda-510k.jpg K233001 - Bioscope Neuromonitor Device K233001 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Biosys Biyomedikal Muhendislik San. VE Tic. A.S.. Cleared Dec 2024. https://www.510kdatabase.net/k233486/ 2024-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k233486-731-series-ventilator-fda-510k.jpg K233486 - 731 Series Ventilator K233486 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: ZOLL Medical Corporation. Cleared Dec 2024. https://www.510kdatabase.net/k240778/ 2024-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k240778-vivo-1-vivo-2-fda-510k.jpg K240778 - Vivo 1, Vivo 2 K240778 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Breas Medical AB. Cleared Dec 2024. https://www.510kdatabase.net/k240779/ 2024-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k240779-vivo-3-fda-510k.jpg K240779 - Vivo 3 K240779 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Breas Medical AB. Cleared Dec 2024. https://www.510kdatabase.net/k240924/ 2024-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k240924-anterion-fda-510k.jpg K240924 - Anterion K240924 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Heidelberg Engineering GmbH. Cleared Dec 2024. https://www.510kdatabase.net/k240998/ 2024-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k240998-abl90-flex-plus-system-fda-510k.jpg K240998 - ABL90 FLEX PLUS System K240998 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Radiometer Medicals Aps. Cleared Dec 2024. https://www.510kdatabase.net/k241160/ 2024-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k241160-cais-sensor-cais-001-fda-510k.jpg K241160 - CAIs Sensor (CAIs-001) K241160 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainu Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k241998/ 2024-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k241998-ice-cooling-ipl-hair-removal-device-fda-510k.jpg K241998 - Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S RE, UI20S PW, UI20S GP,UI20 WH, UI20 GR, UI20 BS, UI20 MP, UI20 BL, UI20 PN, UI20 BR, UI20WG, UI20S WH, UI20S GR, UI20S BS, UI20S MP) K241998 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Ulike Smart Electronics Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k242463/ 2024-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k242463-aria-radiation-therapy-management-fda-510k.jpg K242463 - ARIA Radiation Therapy Management System (18.1) K242463 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k242487/ 2024-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k242487-laminar-p1-ldh-hw-001-fda-510k.jpg K242487 - Laminar P1 (LDH-HW-001) K242487 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Laminar Digital Health, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k242532/ 2024-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k242532-btl-785bnf-e-fda-510k.jpg K242532 - BTL-785BNF-E K242532 is a FDA 510(k) cleared neurology medical device. Manufacturer: BTL Industries, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k242668/ 2024-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k242668-gastro-concepts-air-assist-fda-510k.jpg K242668 - Gastro Concepts Air Assist K242668 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Gastro Concepts, LLC. Cleared Dec 2024. https://www.510kdatabase.net/k243196/ 2024-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k243196-uro-g-hd-cystoscope-1520-fda-510k.jpg K243196 - Uro-G HD Cystoscope (1520) K243196 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Uroviu Corporation. Cleared Dec 2024. https://www.510kdatabase.net/k243281/ 2024-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k243281-lock-in-spinal-fixation-system-fda-510k.jpg K243281 - LOCK-IN Spinal Fixation System K243281 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Lock-In USA Corp. Cleared Dec 2024. https://www.510kdatabase.net/k243307/ 2024-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k243307-lcd-monitor-mdec-2523-fda-510k.jpg K243307 - LCD Monitor (MDEC-2523) K243307 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Barco N.V.. Cleared Dec 2024. https://www.510kdatabase.net/k243493/ 2024-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k243493-agilis-nxt-steerable-introducer-dual-fda-510k.jpg K243493 - Agilis NxT Steerable Introducer Dual-Reach K243493 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared Dec 2024. https://www.510kdatabase.net/k243560/ 2024-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k243560-remex-spine-surgery-navigation-fda-510k.jpg K243560 - Remex Spine Surgery Navigation Instrument K243560 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Remex Medical Corp.. Cleared Dec 2024. https://www.510kdatabase.net/k243635/ 2024-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k243635-aprevo-anterior-lumbar-interbody-fda-510k.jpg K243635 - aprevo® anterior lumbar interbody fusion device with interfixation K243635 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Carlsmed, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k233152/ 2024-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k233152-geniova-aligners-fda-510k.jpg K233152 - GENIOVA aligners K233152 is a FDA 510(k) cleared dental medical device. Manufacturer: Geniova Technologies Sociedad Limitada. Cleared Dec 2024. https://www.510kdatabase.net/k240735/ 2024-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k240735-visiolign-color-visiolign-shield-fda-510k.jpg K240735 - visio.lign color, visio.lign shield K240735 is a FDA 510(k) cleared dental medical device. Manufacturer: Bredent GmbH & Co. KG. Cleared Dec 2024. https://www.510kdatabase.net/k241253/ 2024-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k241253-medicon-epiplating-system-fda-510k.jpg K241253 - Medicon Epiplating System K241253 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cmf Medicon Surgical, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k241271/ 2024-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k241271-aqua-medical-rf-vapor-ablation-system-fda-510k.jpg K241271 - Aqua Medical RF Vapor Ablation System K241271 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Aqua Medical, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k241389/ 2024-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k241389-infrascanner-model-2500-model-2500-fda-510k.jpg K241389 - Infrascanner Model 2500 (Model 2500) K241389 is a FDA 510(k) cleared neurology medical device. Manufacturer: Infrascan, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k242020/ 2024-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k242020-epiq-series-diagnostic-ultrasound-system-fda-510k.jpg K242020 - EPIQ Series Diagnostic Ultrasound System K242020 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Ultrasound, LLC. Cleared Dec 2024. https://www.510kdatabase.net/k242453/ 2024-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k242453-terragene-bionova-photon-process-fda-510k.jpg K242453 - Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2) K242453 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terragene S.A.. Cleared Dec 2024. https://www.510kdatabase.net/k242832/ 2024-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k242832-next-station-fda-510k.jpg K242832 - NExT Station K242832 is a FDA 510(k) cleared neurology medical device. Manufacturer: Eb Neuro S.P.A.. Cleared Dec 2024. https://www.510kdatabase.net/k242934/ 2024-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k242934-bioceramic-root-canal-sealer-and-fda-510k.jpg K242934 - Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP) K242934 is a FDA 510(k) cleared dental medical device. Manufacturer: Longly Biotechnology (Wuhan) Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k243495/ 2024-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k243495-natus-ultrapro-s100-982a0594-fda-510k.jpg K243495 - Natus Ultrapro S100 (982A0594) K243495 is a FDA 510(k) cleared neurology medical device. Manufacturer: Natus Neurology Incorporated. Cleared Dec 2024. https://www.510kdatabase.net/k243538/ 2024-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k243538-umi-panvivo-umi-panvivo-fda-510k.jpg K243538 - uMI Panvivo (uMI Panvivo) K243538 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k243540/ 2024-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k243540-mac-lab-altix-aii-fda-510k.jpg K243540 - Mac-Lab (AltiX AI.i) K243540 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k240758/ 2024-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k240758-radiofrequency-generator-system-cura-fda-510k.jpg K240758 - Radiofrequency Generator System, Cura RF Electrode K240758 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Zhejiang Curaway Medical Technology Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k241045/ 2024-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k241045-disposable-subdermal-needle-electrode-fda-510k.jpg K241045 - Disposable Subdermal Needle Electrode, Corkscrew K241045 is a FDA 510(k) cleared neurology medical device. Manufacturer: Technomed Europe. Cleared Dec 2024. https://www.510kdatabase.net/k241088/ 2024-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k241088-endotool-iv-31-fda-510k.jpg K241088 - EndoTool IV (3.1) K241088 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Monarch Medical Technologies. Cleared Dec 2024. https://www.510kdatabase.net/k241219/ 2024-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k241219-fiberlocker-system-fiberlocker-implant-fda-510k.jpg K241219 - FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN) K241219 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: ZuriMED Technologies AG. Cleared Dec 2024. https://www.510kdatabase.net/k241873/ 2024-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k241873-osseofit-stemless-shoulder-system-fda-510k.jpg K241873 - OsseoFit Stemless Shoulder System K241873 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k242033/ 2024-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k242033-access25-delivery-microcatheter-fda-510k.jpg K242033 - Access25™ Delivery Microcatheter K242033 is a FDA 510(k) cleared neurology medical device. Manufacturer: Penumbra, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k242263/ 2024-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k242263-techfit-disrp-system-fda-510k.jpg K242263 - TECHFIT DISRP® System K242263 is a FDA 510(k) cleared dental medical device. Manufacturer: Techfit Digital Surgery, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k242378/ 2024-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k242378-eclipse-treatment-planning-system-181-fda-510k.jpg K242378 - Eclipse Treatment Planning System (18.1) K242378 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems. Cleared Dec 2024. https://www.510kdatabase.net/k242417/ 2024-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k242417-vectr-video-endoscopic-carpal-tunnel-fda-510k.jpg K242417 - VECTR – Video Endoscopic Carpal Tunnel Release System K242417 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Rafael Medical Devices, LLC. Cleared Dec 2024. https://www.510kdatabase.net/k242747/ 2024-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k242747-faq-302-fda-510k.jpg K242747 - FAQ™ (302) K242747 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Foreo, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k243369/ 2024-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k243369-cervical-plating-system-fda-510k.jpg K243369 - Cervical Plating System K243369 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k243491/ 2024-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k243491-sternalplate-expansion-fda-510k.jpg K243491 - SternalPlate Expansion K243491 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Leibinger GmbH & Co KG. Cleared Dec 2024. https://www.510kdatabase.net/k243498/ 2024-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k243498-alinity-c-benzodiazepines-reagent-kit-fda-510k.jpg K243498 - Alinity c Benzodiazepines Reagent Kit K243498 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Microgenics Corporation. Cleared Dec 2024. https://www.510kdatabase.net/k243548/ 2024-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k243548-briefcase-triage-fda-510k.jpg K243548 - BriefCase-Triage K243548 is a FDA 510(k) cleared radiology medical device. Manufacturer: Aidoc Medical , Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k231216/ 2024-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k231216-potenza-fda-510k.jpg K231216 - POTENZA K231216 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Jeisys Medical, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k241391/ 2024-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k241391-straumann-pure-ceramic-implants-fda-510k.jpg K241391 - Straumann® PURE Ceramic Implants K241391 is a FDA 510(k) cleared dental medical device. Manufacturer: Institut Straumann AG. Cleared Dec 2024. https://www.510kdatabase.net/k241505/ 2024-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k241505-drx-revolution-mobile-x-ray-system-fda-510k.jpg K241505 - DRX-Revolution Mobile X-ray System K241505 is a FDA 510(k) cleared radiology medical device. Manufacturer: Carestream Health, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k241521/ 2024-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k241521-prelude-small-od-introducer-guide-wire-fda-510k.jpg K241521 - Prelude Small O.D. Introducer Guide Wire K241521 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k242025/ 2024-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k242025-elos-accurate-hybrid-base-fda-510k.jpg K242025 - Elos Accurate® Hybrid Base™ K242025 is a FDA 510(k) cleared dental medical device. Manufacturer: Elos Medtech Pinol A/S. Cleared Dec 2024. https://www.510kdatabase.net/k242327/ 2024-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k242327-empulse-m90-fda-510k.jpg K242327 - Empulse M90 K242327 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Concourse Assistive Technology Pty, Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k242461/ 2024-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k242461-iriseg-fda-510k.jpg K242461 - IRISeg K242461 is a FDA 510(k) cleared radiology medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k242511/ 2024-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k242511-v5-diagnostic-ultrasound-system-h5-fda-510k.jpg K242511 - V5 Diagnostic Ultrasound System, H5 Diagnostic Ultrasound System, XV5 Diagnostic Ultrasound System, XH5 Diagnostic Ultrasound System, V4 Diagnostic Ultrasound System, H4 Diagnostic Ultrasound System, XV4 Diagnostic Ultrasound System, XH4 Diagnostic Ultrasound System K242511 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Medison Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k242630/ 2024-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k242630-aerin-console-fda-510k.jpg K242630 - Aerin Console K242630 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aerin Medical, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k242848/ 2024-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k242848-philips-intellisite-pathology-solution-fda-510k.jpg K242848 - Philips IntelliSite Pathology Solution 5.1 K242848 is a FDA 510(k) cleared pathology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Dec 2024. https://www.510kdatabase.net/k243132/ 2024-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k243132-digital-color-doppler-ultrasound-fda-510k.jpg K243132 - Digital Color Doppler Ultrasound Imaging System (Readius L15) K243132 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shantou Institute of Ultrasonic Instruments Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k243216/ 2024-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k243216-sensinel-cardiopulmonary-management-fda-510k.jpg K243216 - Sensinel Cardiopulmonary Management (CPM) System (ADCP1100) K243216 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Analog Devices. Cleared Dec 2024. https://www.510kdatabase.net/k240706/ 2024-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k240706-powercube-series-powercube-body-fda-510k.jpg K240706 - PowerCube+ Series (PowerCube Body+) K240706 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Ganshorn Medizin Electronic GmbH. Cleared Dec 2024. https://www.510kdatabase.net/k240841/ 2024-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k240841-digital-radiography-system-manntix-b-fda-510k.jpg K240841 - Digital Radiography System (ManntiX B, ManntiX K) K240841 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Browiner Tech Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k242451/ 2024-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k242451-hemosphere-alta-advanced-monitoring-fda-510k.jpg K242451 - HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1) K242451 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences. Cleared Dec 2024. https://www.510kdatabase.net/k242508/ 2024-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k242508-verily-numetric-retinal-camera-fda-510k.jpg K242508 - Verily Numetric Retinal Camera K242508 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Verily Life Sciences, LLC. Cleared Dec 2024. https://www.510kdatabase.net/k242729/ 2024-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k242729-autocontour-model-radac-v4-fda-510k.jpg K242729 - AutoContour (Model RADAC V4) K242729 is a FDA 510(k) cleared radiology medical device. Manufacturer: Radformation, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k242758/ 2024-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k242758-atrauman-ag-fda-510k.jpg K242758 - Atrauman® Ag K242758 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Hartmann USA, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k243364/ 2024-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k243364-trigen-meta-tan-trochanteric-antegrade-fda-510k.jpg K243364 - TRIGEN META-TAN Trochanteric Antegrade Nail K243364 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k240700/ 2024-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k240700-homesleeptest-hst-hst-rem-fda-510k.jpg K240700 - HomeSleepTest (HST, HST REM+) K240700 is a FDA 510(k) cleared neurology medical device. Manufacturer: Somnomedics GmbH. Cleared Dec 2024. https://www.510kdatabase.net/k240461/ 2024-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k240461-osteosinter-evans-and-cotton-wedges-fda-510k.jpg K240461 - OsteoSinter® EVANS and COTTON wedges and related accessories K240461 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ames Medical Prosthetic Solutions, S.A.U.. Cleared Dec 2024. https://www.510kdatabase.net/k240561/ 2024-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k240561-rugged-oxygen-generator-rog-ro01-00001-fda-510k.jpg K240561 - Rugged Oxygen Generator (ROG) (RO01-00001) K240561 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Molecular Products , Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k240680/ 2024-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k240680-cdm-insights-fda-510k.jpg K240680 - CDM Insights K240680 is a FDA 510(k) cleared radiology medical device. Manufacturer: Oxford Brain Diagnostics, Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k240840/ 2024-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k240840-oxygen-concentrator-zy-10ab115-fda-510k.jpg K240840 - Oxygen Concentrator (ZY-10AB/115) K240840 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Foshan Care Medical Technology Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k240926/ 2024-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k240926-peekmed-web-fda-510k.jpg K240926 - PeekMed web K240926 is a FDA 510(k) cleared radiology medical device. Manufacturer: Peek Health, S.A.. Cleared Dec 2024. https://www.510kdatabase.net/k240971/ 2024-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k240971-87-neuglide-catheter-fda-510k.jpg K240971 - 87 NeuGlide Catheter K240971 is a FDA 510(k) cleared neurology medical device. Manufacturer: Piraeus Medical. Cleared Dec 2024. https://www.510kdatabase.net/k241073/ 2024-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k241073-dz-tabone-intervertebral-body-fusion-fda-510k.jpg K241073 - DZ-Tabone Intervertebral Body Fusion Device K241073 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Shenzhen Dazhou Medical Technology Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k241213/ 2024-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k241213-pentax-medical-video-upper-gi-scope-fda-510k.jpg K241213 - PENTAX Medical Video Upper GI Scope (EG27-i20c) K241213 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Pentax of America, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k241260/ 2024-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k241260-actify-unicondylar-knee-system-fda-510k.jpg K241260 - ACTIFY™ Unicondylar Knee System K241260 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k241543/ 2024-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k241543-draid-for-liver-segmentation-fda-510k.jpg K241543 - DrAid™ for Liver Segmentation K241543 is a FDA 510(k) cleared radiology medical device. Manufacturer: Vinbrain Joint Stock Company. Cleared Dec 2024. https://www.510kdatabase.net/k241567/ 2024-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k241567-mc2-portable-x-ray-system-fda-510k.jpg K241567 - MC2 Portable X-ray System K241567 is a FDA 510(k) cleared radiology medical device. Manufacturer: Oxos Medical. Cleared Dec 2024. https://www.510kdatabase.net/k241580/ 2024-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k241580-alinity-m-sars-cov-2-amp-kit-09n78-096-fda-510k.jpg K241580 - Alinity m SARS-CoV-2 AMP Kit (09N78-096) K241580 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Molecular. Cleared Dec 2024. https://www.510kdatabase.net/k241878/ 2024-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k241878-tornier-humeral-reconstruction-system-fda-510k.jpg K241878 - Tornier Humeral Reconstruction System (Tornier HRS) K241878 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Corporation (Tornier, Inc.). Cleared Dec 2024. https://www.510kdatabase.net/k241923/ 2024-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k241923-efai-neurosuite-ct-midline-shift-fda-510k.jpg K241923 - EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100) K241923 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ever Fortune.Ai, Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k241946/ 2024-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k241946-peritx-1l-drainage-kit-90-1010-fda-510k.jpg K241946 - PeritX™ 1L Drainage Kit (90-1010) K241946 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Bard Peripheral Vascular, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k241989/ 2024-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k241989-cercare-medical-neurosuite-cmn-fda-510k.jpg K241989 - Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert K241989 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cercare Medical A/S. Cleared Dec 2024. https://www.510kdatabase.net/k242304/ 2024-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k242304-red-fda-510k.jpg K242304 - RED K242304 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Neuraxis, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k242524/ 2024-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k242524-symri-fda-510k.jpg K242524 - SyMRI K242524 is a FDA 510(k) cleared radiology medical device. Manufacturer: Syntheticmr AB (Publ.). Cleared Dec 2024. https://www.510kdatabase.net/k242645/ 2024-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k242645-ina-moisturizing-intimate-lubricant-fda-510k.jpg K242645 - INA Moisturizing Intimate Lubricant Water-Based Personal Lubricant K242645 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Project Chemistry, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k242687/ 2024-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k242687-nanoknife-generator-h78720300301us0-fda-510k.jpg K242687 - NanoKnife Generator (H78720300301US0) K242687 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: AngioDynamics, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k242710/ 2024-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k242710-hair-removal-device-r3c16-p-r3c16-w-fda-510k.jpg K242710 - Hair Removal Device (R3C16-P, R3C16-W, R3C16-G, R3C16-P Pro, R3C16-W Pro, R3C16-G Pro, R3505-W, R3505-B, R3505-W Pro, R3505-B Pro) K242710 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Jianchao Intelligent Technology Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k242824/ 2024-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k242824-ptfe-guidewire-fda-510k.jpg K242824 - PTFE Guidewire K242824 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Lake Region Medical. Cleared Dec 2024. https://www.510kdatabase.net/k242950/ 2024-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k242950-wallflex-biliary-plus-rx-stent-system-fda-510k.jpg K242950 - WallFlex Biliary PLUS RX Stent System K242950 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific. Cleared Dec 2024. https://www.510kdatabase.net/k243073/ 2024-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k243073-anyplus-navigated-instruments-system-fda-510k.jpg K243073 - AnyPlus Navigated Instruments System K243073 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: GS Medical Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k243486/ 2024-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k243486-smartsitetm-vented-vial-access-device-fda-510k.jpg K243486 - SmartSiteTM Vented Vial Access Device K243486 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Yukon Medical, LLC. Cleared Dec 2024. https://www.510kdatabase.net/k241128/ 2024-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k241128-tdm-plate-and-screw-system-fda-510k.jpg K241128 - TDM Plate and Screw System K241128 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tdm Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k241674/ 2024-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k241674-osteopal-v-fda-510k.jpg K241674 - OSTEOPAL® V K241674 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Heraeus Medical GmbH. Cleared Dec 2024. https://www.510kdatabase.net/k242525/ 2024-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k242525-itof-fda-510k.jpg K242525 - iTOF® K242525 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Nerbio Medical Software Platforms, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k242653/ 2024-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k242653-the-sensititre-18-24-hour-mic-or-fda-510k.jpg K242653 - The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Linezolid in the dilution range of 0.25-32 ug/mL K242653 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Thermo Fisher Scientific. Cleared Dec 2024. https://www.510kdatabase.net/k242703/ 2024-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k242703-lw-pre-milled-abutment-fda-510k.jpg K242703 - LW Pre-milled Abutment K242703 is a FDA 510(k) cleared dental medical device. Manufacturer: Ossvis Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k242740/ 2024-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k242740-dental-lithium-disilicate-glass-fda-510k.jpg K242740 - Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO) K242740 is a FDA 510(k) cleared dental medical device. Manufacturer: Liaoning Rachcera Material Technology Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k243435/ 2024-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k243435-magnetic-localization-patch-kit-afr-fda-510k.jpg K243435 - Magnetic Localization Patch Kit (AFR-00021) K243435 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k243444/ 2024-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k243444-bioceram-azul-head-fda-510k.jpg K243444 - BIOCERAM AZUL® HEAD K243444 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Kyocera Corporation. Cleared Dec 2024. https://www.510kdatabase.net/k243447/ 2024-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k243447-rapid-surgical-plan-rsp-sw-001-fda-510k.jpg K243447 - Rapid Surgical Plan (RSP-SW-001) K243447 is a FDA 510(k) cleared radiology medical device. Manufacturer: Navbit Pty, Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k243463/ 2024-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k243463-biofire-filmarray-tropical-fever-panel-fda-510k.jpg K243463 - BIOFIRE FILMARRAY Tropical Fever Panel K243463 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Biofire Diagnostics, LLC (Biomerieux). Cleared Dec 2024. https://www.510kdatabase.net/k243526/ 2024-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k243526-montage-settable-resorbable-bone-putty-fda-510k.jpg K243526 - MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, Resorbable Bone Putty MONTAGE Flowable Settable, Resorbable Bone Paste MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty K243526 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthocon, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/den240025/ 2024-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/den240025-ventana-kappa-and-lambda-dual-ish-mrna-fda-510k.jpg DEN240025 - VENTANA Kappa and Lambda Dual ISH mRNA Probe Cocktail (08507023001) DEN240025 is a FDA 510(k) cleared pathology medical device. Manufacturer: Ventana Medical Systems, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k240671/ 2024-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k240671-xbeam-v2-fda-510k.jpg K240671 - XBeam (v2) K240671 is a FDA 510(k) cleared radiology medical device. Manufacturer: Xstrahl, Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k241197/ 2024-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k241197-deeprhythmai-fda-510k.jpg K241197 - DeepRhythmAI K241197 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medicalgorithmics S.A.. Cleared Dec 2024. https://www.510kdatabase.net/k242184/ 2024-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k242184-alcon-27ga-chandelier-8065000252-fda-510k.jpg K242184 - Alcon 27GA Chandelier (8065000252) K242184 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Alcon Laboratories, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k242185/ 2024-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k242185-rextar-pro-fda-510k.jpg K242185 - Rextar Pro K242185 is a FDA 510(k) cleared radiology medical device. Manufacturer: Raypia Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k242301/ 2024-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k242301-socrates-38-catheter-fda-510k.jpg K242301 - Socrates 38 Catheter K242301 is a FDA 510(k) cleared neurology medical device. Manufacturer: Scientia Vascular, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k242348/ 2024-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k242348-locking-screwcocrmo-fda-510k.jpg K242348 - Locking Screw,CoCrMo K242348 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Double Medical Technology, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k242395/ 2024-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k242395-nanoxarc-fda-510k.jpg K242395 - Nanox.ARC K242395 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nano-X Imaging , Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k242643/ 2024-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k242643-capsocam-plus-sv-3-capsule-endoscopy-fda-510k.jpg K242643 - CapsoCam Plus (SV-3) Capsule Endoscopy System K242643 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: CapsoVision, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k242685/ 2024-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k242685-atellica-ch-creatinine3-crea3-fda-510k.jpg K242685 - Atellica® CH Creatinine_3 (Crea3) K242685 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k242686/ 2024-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k242686-neodent-implant-system-fda-510k.jpg K242686 - Neodent Implant System K242686 is a FDA 510(k) cleared dental medical device. Manufacturer: Jjgc Ind?stria E Com?rcia DE Materiais Dent?rios S.A.. Cleared Dec 2024. https://www.510kdatabase.net/k242831/ 2024-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k242831-triathlon-knee-system-fda-510k.jpg K242831 - Triathlon Knee System K242831 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp., Dba Stryker Orthopaedics. Cleared Dec 2024. https://www.510kdatabase.net/k243180/ 2024-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k243180-sspc-nxt-delivery-catheter-fda-510k.jpg K243180 - SSPC NXT Delivery Catheter K243180 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: CenterPoint Systems, LLC. Cleared Dec 2024. https://www.510kdatabase.net/k243265/ 2024-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k243265-ion-3d-fda-510k.jpg K243265 - Ion 3D K243265 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SurGenTec, LLC. Cleared Dec 2024. https://www.510kdatabase.net/k243417/ 2024-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k243417-relievrx-fda-510k.jpg K243417 - RelieVRx K243417 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Appliedvr. Cleared Dec 2024. https://www.510kdatabase.net/k243475/ 2024-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k243475-chemical-indicator-for-enspire-clcsps-fda-510k.jpg K243475 - Chemical Indicator for enspire CLCSPS (LCC015) K243475 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Dec 2024. https://www.510kdatabase.net/k241486/ 2024-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k241486-sofsilk-coated-braided-silk-suture-fda-510k.jpg K241486 - Sofsilk™ Coated Braided Silk Suture K241486 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien. Cleared Dec 2024. https://www.510kdatabase.net/k242188/ 2024-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k242188-clearread-ct-cac-fda-510k.jpg K242188 - ClearRead CT CAC K242188 is a FDA 510(k) cleared radiology medical device. Manufacturer: Riverain Technologies, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k242861/ 2024-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k242861-truelok-elevate-fda-510k.jpg K242861 - TrueLok Elevate K242861 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthofix Srl. Cleared Dec 2024. https://www.510kdatabase.net/k243454/ 2024-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k243454-verruca-freeze-h-fda-510k.jpg K243454 - Verruca-Freeze H K243454 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cryosurgery, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k243467/ 2024-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k243467-fix2lock-biocomposite-medial-fda-510k.jpg K243467 - Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) K243467 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonic Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k243470/ 2024-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k243470-fix2lock-peek-self-punching-fda-510k.jpg K243470 - Fix2Lock (PEEK Self Punching) K243470 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonic Co., Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k223120/ 2024-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k223120-ventoux-vc2-fda-510k.jpg K223120 - Ventoux VC2 K223120 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Flight Medical Innovations , Ltd.. Cleared Dec 2024. https://www.510kdatabase.net/k240475/ 2024-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k240475-hintermann-series-h2-total-ankle-system-fda-510k.jpg K240475 - Hintermann Series H2 Total Ankle System K240475 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Vilex, LLC. Cleared Dec 2024. https://www.510kdatabase.net/k241871/ 2024-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k241871-philips-intellisite-pathology-solution-fda-510k.jpg K241871 - Philips IntelliSite Pathology Solution K241871 is a FDA 510(k) cleared pathology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Dec 2024. https://www.510kdatabase.net/k242619/ 2024-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k242619-growell-bt-hair-growth-system-gw10042-fda-510k.jpg K242619 - GroWell BT Hair Growth System (GW10042) K242619 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Apira Science, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k243020/ 2024-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k243020-midasvu-fda-510k.jpg K243020 - MIDASVu K243020 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Intravu, Inc.. Cleared Dec 2024. https://www.510kdatabase.net/k243232/ 2024-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k243232-gripmate-fda-510k.jpg K243232 - GripMate K243232 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Synthon Hispania S.L.. Cleared Dec 2024. https://www.510kdatabase.net/k243418/ 2024-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k243418-riptide-aspiration-pump-fda-510k.jpg K243418 - Riptide™ Aspiration Pump K243418 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. Cleared Dec 2024. https://www.510kdatabase.net/k243433/ 2024-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k243433-enspire-3000-cleaning-and-liquid-fda-510k.jpg K243433 - enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System K243433 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Dec 2024. https://www.510kdatabase.net/k241090/ 2024-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k241090-evie-med-ring-fda-510k.jpg K241090 - Evie Med Ring K241090 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Movano Inc. Dba Movano Health. Cleared Nov 2024. https://www.510kdatabase.net/k241628/ 2024-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k241628-yo-home-sperm-test-fda-510k.jpg K241628 - YO Home Sperm Test K241628 is a FDA 510(k) cleared hematology medical device. Manufacturer: Medical Electronic Systems , Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k242225/ 2024-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k242225-medline-renewal-reprocessed-abbott-fda-510k.jpg K242225 - Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter K242225 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Surgical Instrument Service and Savings, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k243375/ 2024-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k243375-ruthless-spine-rjb-fda-510k.jpg K243375 - Ruthless Spine RJB K243375 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ruthless, LLC Dba Ruthless Spine. Cleared Nov 2024. https://www.510kdatabase.net/k233273/ 2024-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k233273-cb-ceramic-fda-510k.jpg K233273 - C&B Ceramic K233273 is a FDA 510(k) cleared dental medical device. Manufacturer: Prevest Denpro Limited. Cleared Nov 2024. https://www.510kdatabase.net/k240645/ 2024-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k240645-sonix-health-fda-510k.jpg K240645 - Sonix Health K240645 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ontact Health Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k240994/ 2024-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k240994-nexpowder-fda-510k.jpg K240994 - Nexpowder K240994 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Nextbiomedical Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k241115/ 2024-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k241115-sv-spectrum-mrc-central-venous-catheter-fda-510k.jpg K241115 - SV Spectrum MRC Central Venous Catheter K241115 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Spectrum Vascular. Cleared Nov 2024. https://www.510kdatabase.net/k241353/ 2024-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k241353-powerloc-max-power-injectable-infusion-fda-510k.jpg K241353 - PowerLoc™ Max Power Injectable Infusion Set K241353 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bard Access Systems, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k241835/ 2024-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k241835-airsculpt-body-contouring-system-airs-fda-510k.jpg K241835 - AirSculpt Body Contouring System (AIRS-1-SYS) K241835 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cellmyx. Cleared Nov 2024. https://www.510kdatabase.net/k241899/ 2024-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k241899-pelvic-floor-stimulator-intrelief-pfe-fda-510k.jpg K241899 - Pelvic Floor Stimulator (Intrelief PFE) K241899 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Easymed Instruments Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k242187/ 2024-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k242187-biobrace-fda-510k.jpg K242187 - BioBrace® K242187 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Conmed Corporation. Cleared Nov 2024. https://www.510kdatabase.net/k242308/ 2024-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k242308-power-wheelchair-fda-510k.jpg K242308 - Power wheelchair K242308 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zhejiang Zhonglei Medical Technology Co. , Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k242444/ 2024-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k242444-hera-w10-diagnostic-ultrasound-system-fda-510k.jpg K242444 - HERA W10 Diagnostic Ultrasound System K242444 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Medison Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k242638/ 2024-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k242638-led-light-therapy-machine-g1-g3-g4-g6-fda-510k.jpg K242638 - LED Light Therapy Machine (G1, G3, G4, G6) K242638 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Walton Technology Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k242796/ 2024-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k242796-cryoglow-fw3xxxx-fda-510k.jpg K242796 - CryoGlow (FW3XXXX) K242796 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sharkninja Operating, LLC. Cleared Nov 2024. https://www.510kdatabase.net/k243221/ 2024-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k243221-radiforce-rx570-fda-510k.jpg K243221 - RadiForce RX570 K243221 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eizo Corporation. Cleared Nov 2024. https://www.510kdatabase.net/k243354/ 2024-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k243354-remunity-system-fda-510k.jpg K243354 - Remunity System K243354 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Deka Research & Development Corp.. Cleared Nov 2024. https://www.510kdatabase.net/k243355/ 2024-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k243355-ceragem-automatic-thermal-massager-cgm-fda-510k.jpg K243355 - Ceragem Automatic Thermal Massager (CGM-MB-1902) K243355 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Ceragem Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k243362/ 2024-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k243362-smoothskin-pure-switch-ssc1-fda-510k.jpg K243362 - SmoothSkin Pure Switch (SSC1) K243362 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cyden Limited. Cleared Nov 2024. https://www.510kdatabase.net/k243408/ 2024-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k243408-tactix-vector-syndesmosis-system-fda-510k.jpg K243408 - TACTIX Vector Syndesmosis System K243408 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Vilex, LLC. Cleared Nov 2024. https://www.510kdatabase.net/k243409/ 2024-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k243409-karl-storz-pediatric-cysto-urethro-fda-510k.jpg K243409 - KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1) K243409 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Karl Storz SE & CO. KG. Cleared Nov 2024. https://www.510kdatabase.net/k231655/ 2024-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k231655-4cis-chiron-spinal-fixation-system-fda-510k.jpg K231655 - 4CIS® Chiron Spinal Fixation System K231655 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Solco Biomedical Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k231859/ 2024-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k231859-primmaart-fda-510k.jpg K231859 - PrimmaArt K231859 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentscare Ltda. Cleared Nov 2024. https://www.510kdatabase.net/k240650/ 2024-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k240650-lungprotect-fda-510k.jpg K240650 - LungProtect K240650 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Traferox Technologies, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k240818/ 2024-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k240818-r2p-radifocus-glidewire-advantage-fda-510k.jpg K240818 - R2P Radifocus Glidewire Advantage K240818 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Corporation. Cleared Nov 2024. https://www.510kdatabase.net/k240897/ 2024-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k240897-cellinew-fda-510k.jpg K240897 - Cellinew K240897 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: VIOL Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k241390/ 2024-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k241390-neuromatch-fda-510k.jpg K241390 - NeuroMatch K241390 is a FDA 510(k) cleared neurology medical device. Manufacturer: LVIS Corporation. Cleared Nov 2024. https://www.510kdatabase.net/k241995/ 2024-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k241995-hyperflex-bunion-correction-system-fda-510k.jpg K241995 - HyperFlex™ Bunion Correction System K241995 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Footbridge Medical. Cleared Nov 2024. https://www.510kdatabase.net/k242049/ 2024-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k242049-surecath-set-fda-510k.jpg K242049 - SureCath Set K242049 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Coloplast Corp.. Cleared Nov 2024. https://www.510kdatabase.net/k242258/ 2024-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k242258-mropen-evo-03-2000-00-fda-510k.jpg K242258 - MROpen Evo (03-2000-00) K242258 is a FDA 510(k) cleared radiology medical device. Manufacturer: Asg Superconductors S.P.A.. Cleared Nov 2024. https://www.510kdatabase.net/k242318/ 2024-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k242318-da-vinci-sp-surgical-system-sp1098-fda-510k.jpg K242318 - da Vinci SP Surgical System (SP1098) K242318 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k242494/ 2024-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k242494-osseofit-interfacing-anchor-fda-510k.jpg K242494 - OsseoFit Interfacing Anchor K242494 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Riverpoint Medical, LLC. Cleared Nov 2024. https://www.510kdatabase.net/k242559/ 2024-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k242559-digital-temp-fda-510k.jpg K242559 - Digital Temp K242559 is a FDA 510(k) cleared dental medical device. Manufacturer: Sprintray, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k242631/ 2024-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k242631-regeneten-bioinductive-implant-fda-510k.jpg K242631 - REGENETEN™ Bioinductive Implant K242631 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew Inc., Endoscopy Div.. Cleared Nov 2024. https://www.510kdatabase.net/k242657/ 2024-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k242657-the-sensititre-18-24-hour-mic-or-fda-510k.jpg K242657 - The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Daptomycin in the dilution range of 0.03-64 ug/mL K242657 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Thermo Fisher Scientific. Cleared Nov 2024. https://www.510kdatabase.net/k242810/ 2024-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k242810-radunity-version-100-fda-510k.jpg K242810 - RadUnity (Version 1.0.0) K242810 is a FDA 510(k) cleared radiology medical device. Manufacturer: Radunity Corp.. Cleared Nov 2024. https://www.510kdatabase.net/k242961/ 2024-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k242961-intraluminal-applicator-set-fda-510k.jpg K242961 - Intraluminal Applicator Set K242961 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems. Cleared Nov 2024. https://www.510kdatabase.net/k243050/ 2024-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k243050-trimed-posterior-malleolus-fixation-fda-510k.jpg K243050 - TriMed Posterior Malleolus Fixation System K243050 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: TriMed, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k243118/ 2024-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k243118-arm-blood-pressure-monitor-model-bpm-fda-510k.jpg K243118 - Arm Blood Pressure Monitor (model: BPM-A7VL) K243118 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Imdk Medical Technology Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k243191/ 2024-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k243191-atlas-spine-lateral-expandable-fda-510k.jpg K243191 - Atlas Spine Lateral Expandable Interbody System K243191 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Atlas Spine, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k243193/ 2024-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k243193-cross-wise-multi-use-rf-adapter-cable-fda-510k.jpg K243193 - Cross Wise™ Multi-Use RF Adapter Cable K243193 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Circa Scientific, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k232588/ 2024-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k232588-aluna-2-fda-510k.jpg K232588 - Aluna 2 K232588 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Knox Medical Diagnostics. Cleared Nov 2024. https://www.510kdatabase.net/k232982/ 2024-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k232982-ems-sculpt-machine-fda-510k.jpg K232982 - EMS Sculpt Machine K232982 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Shandong Huamei Technology Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k240575/ 2024-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k240575-waveguard-net-eeg-cap-na-245-na-255-na-fda-510k.jpg K240575 - WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281) K240575 is a FDA 510(k) cleared neurology medical device. Manufacturer: Eemagine Medical Imaging Solutions GmbH. Cleared Nov 2024. https://www.510kdatabase.net/k241588/ 2024-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k241588-electric-wheelchair-kr8803-fda-510k.jpg K241588 - Electric Wheelchair (KR8803) K241588 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zhejiang Kairui Medical Device Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k241692/ 2024-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k241692-mis-lynx-conical-connection-implant-fda-510k.jpg K241692 - MIS LYNX Conical Connection Implant System K241692 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k241831/ 2024-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k241831-transpara-210-fda-510k.jpg K241831 - Transpara (2.1.0) K241831 is a FDA 510(k) cleared radiology medical device. Manufacturer: Screenpoint Medical B.V.. Cleared Nov 2024. https://www.510kdatabase.net/k241851/ 2024-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k241851-versus-catheter-vs110-8b-fda-510k.jpg K241851 - Versus™ Catheter (VS110-8B) K241851 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Liquet Medical, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k242245/ 2024-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k242245-customized-abutment-fda-510k.jpg K242245 - Customized Abutment K242245 is a FDA 510(k) cleared dental medical device. Manufacturer: Arum Dentistry Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k242253/ 2024-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k242253-jarvis-glenoid-reverse-shoulder-fda-510k.jpg K242253 - JARVIS Glenoid Reverse Shoulder Prosthesis K242253 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: FH Industrie. Cleared Nov 2024. https://www.510kdatabase.net/k242538/ 2024-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k242538-3m-attest-super-rapid-readout-fda-510k.jpg K242538 - 3M™ Attest™ Super Rapid Readout Biological Indicator 1493 K242538 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Nov 2024. https://www.510kdatabase.net/k242971/ 2024-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k242971-accursound-electronic-stethoscope-as101-fda-510k.jpg K242971 - AccurSound Electronic Stethoscope (AS101) K242971 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Heroic Faith International , Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k243162/ 2024-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k243162-world-liner-fda-510k.jpg K243162 - World Liner K243162 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Signature Orthopaedics Pty, Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k243345/ 2024-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k243345-aptima-bv-assay-fda-510k.jpg K243345 - Aptima BV Assay K243345 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Hologic, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k221326/ 2024-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k221326-nova-allegro-hba1c-assay-nova-allegro-fda-510k.jpg K221326 - Nova Allegro HbA1c Assay, Nova Allegro Analyzer K221326 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Nova Biomedical Corporation. Cleared Nov 2024. https://www.510kdatabase.net/k233567/ 2024-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k233567-osteocoil-nitinol-compression-system-fda-510k.jpg K233567 - OsteoCoil™ Nitinol Compression System (Multiple Component PNs) K233567 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Flower Orthopedics Corporation Dba Conventus Flower Ortho. Cleared Nov 2024. https://www.510kdatabase.net/k240632/ 2024-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k240632-neuvotion-neustim-nn-01-fda-510k.jpg K240632 - Neuvotion NeuStim NN-01 K240632 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neuvotion, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k241169/ 2024-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k241169-entarik-ni-feeding-tube-system-fda-510k.jpg K241169 - Entarik NI Feeding Tube System K241169 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Gravitas Medical, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k241529/ 2024-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k241529-powered-wheelchair-nxn20-209-fda-510k.jpg K241529 - Powered Wheelchair (NXN20-209) K241529 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zhejiang Nysin Medical Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k241953/ 2024-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k241953-sprotte-standard-luer-nrfit-fda-510k.jpg K241953 - SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology K241953 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: PAJUNK GmbH Medizintechnologie. Cleared Nov 2024. https://www.510kdatabase.net/k242002/ 2024-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k242002-femvue-mini-saline-air-device-fda-510k.jpg K242002 - FemVue MINI Saline-Air Device K242002 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Femasys, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k242094/ 2024-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k242094-dreem-3s-fda-510k.jpg K242094 - Dreem 3S K242094 is a FDA 510(k) cleared neurology medical device. Manufacturer: Beacon Biosignals, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k242203/ 2024-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k242203-briefcase-quantification-fda-510k.jpg K242203 - BriefCase-Quantification K242203 is a FDA 510(k) cleared radiology medical device. Manufacturer: Aidoc Medical , Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k242259/ 2024-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k242259-cala-kiq-fda-510k.jpg K242259 - Cala kIQ K242259 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cala Health, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k242543/ 2024-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k242543-persona-the-personalized-knee-system-fda-510k.jpg K242543 - Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs) K242543 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k242722/ 2024-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k242722-manual-wheelchair-masy23-fda-510k.jpg K242722 - Manual Wheelchair (MASY23) K242722 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Sichuan Ast Medical Equipment Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k242884/ 2024-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k242884-additively-manufactured-denture-resin-fda-510k.jpg K242884 - Additively Manufactured Denture Resin K242884 is a FDA 510(k) cleared dental medical device. Manufacturer: Aidite (Qinhuangdao) Technology Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k242913/ 2024-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k242913-jasmate-toothpaste-fda-510k.jpg K242913 - Jasmate® Toothpaste K242913 is a FDA 510(k) cleared dental medical device. Manufacturer: Jasberry Healthcare Private Limited. Cleared Nov 2024. https://www.510kdatabase.net/k242927/ 2024-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k242927-suction-irrigation-tubing-set-fda-510k.jpg K242927 - Suction Irrigation Tubing Set K242927 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Advamedix, GmbH. Cleared Nov 2024. https://www.510kdatabase.net/k242968/ 2024-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k242968-giftlife-single-step-medium-plus-fda-510k.jpg K242968 - Giftlife® Single-Step Medium Plus K242968 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Gimbo Medical Technology Shenzhen Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k243334/ 2024-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k243334-nooro-body-foot-stimulator-sm9141-sm9142-fda-510k.jpg K243334 - Nooro Body & Foot Stimulator (SM9141, SM9142) K243334 is a FDA 510(k) cleared neurology medical device. Manufacturer: Xf Agencija Limited. Cleared Nov 2024. https://www.510kdatabase.net/k232520/ 2024-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k232520-fingertip-pulse-oximeter-models-fda-510k.jpg K232520 - Fingertip Pulse Oximeter, models Alpine20, Alpine20A, Alpine20H, Alpine20HA, Alpine20B, Alpine20BA, Alpine20BH, Alpine20BHA, Alpine30, Alpine30A, Alpine30H, Alpine30HA, Alpine30B, Alpine30BA, Alpine30BH, Alpine30BHA, Alpine20L, Alpine20LB, Alpine20LH, Alpine20LBH, Alpine30L, Alpine30LB, Alpine30LH, Alpine30LBH K232520 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Smallsignal Technology Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k240569/ 2024-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k240569-fesl-fink-chamber-fda-510k.jpg K240569 - FESL FINK Chamber K240569 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Fink Engineering Pty, Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k241157/ 2024-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k241157-secret-max-multi-platform-rf-system-fda-510k.jpg K241157 - Secret MAX Multi-platform RF System K241157 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ilooda Co,., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k241210/ 2024-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k241210-luja-coude-fda-510k.jpg K241210 - Luja Coude K241210 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Coloplast Corp.. Cleared Nov 2024. https://www.510kdatabase.net/k241319/ 2024-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k241319-skr-3000-fda-510k.jpg K241319 - SKR 3000 K241319 is a FDA 510(k) cleared radiology medical device. Manufacturer: Konica Minolta, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k241495/ 2024-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k241495-jazz-classic-fda-510k.jpg K241495 - Jazz Classic K241495 is a FDA 510(k) cleared radiology medical device. Manufacturer: Jazz Imaging. Cleared Nov 2024. https://www.510kdatabase.net/k242414/ 2024-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k242414-tilink-p-joint-fusion-system-fda-510k.jpg K242414 - TiLink-P Joint Fusion System K242414 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SurGenTec, LLC. Cleared Nov 2024. https://www.510kdatabase.net/k242553/ 2024-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k242553-mirari-cold-plasma-system-gv-m2-01-fda-510k.jpg K242553 - MIRARI® Cold Plasma System ( GV-M2-01) K242553 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: General Vibronics, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k242596/ 2024-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k242596-versalock-mini-and-micro-plating-system-fda-510k.jpg K242596 - Versalock Mini and Micro Plating System K242596 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: GM Dos Reis Industria e Comercio Ltda.. Cleared Nov 2024. https://www.510kdatabase.net/k242799/ 2024-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k242799-pliafx-flo-fda-510k.jpg K242799 - PliaFX Flo K242799 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Lifenet Health. Cleared Nov 2024. https://www.510kdatabase.net/k242871/ 2024-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k242871-attune-revision-hinge-knee-fda-510k.jpg K242871 - ATTUNE™ Revision Hinge Knee K242871 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Ireland UC. Cleared Nov 2024. https://www.510kdatabase.net/k242874/ 2024-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k242874-gating-reflector-block-fda-510k.jpg K242874 - Gating Reflector Block K242874 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k242998/ 2024-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k242998-gmreis-ankle-plating-system-fda-510k.jpg K242998 - GMReis Ankle Plating System K242998 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: GM Dos Reis Industria e Comercio Ltda.. Cleared Nov 2024. https://www.510kdatabase.net/k243405/ 2024-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k243405-xpert-vana-fda-510k.jpg K243405 - Xpert vanA K243405 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Cepheid. Cleared Nov 2024. https://www.510kdatabase.net/k232965/ 2024-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k232965-leg-massager-modelsrp-alm070h-rp-alm071h-fda-510k.jpg K232965 - Leg Massager (Models:RP-ALM070H, RP-ALM071H) K232965 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Shenzhen Ruiyi Business Technology Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k240716/ 2024-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k240716-aetos-shoulder-system-stemless-humeral-fda-510k.jpg K240716 - AETOS Shoulder System Stemless Humeral Prosthesis K240716 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k240746/ 2024-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k240746-neurovascular-access-system-family-fda-510k.jpg K240746 - Neurovascular Access System Family K240746 is a FDA 510(k) cleared neurology medical device. Manufacturer: Q'Apel Medical, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k240856/ 2024-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k240856-hip-spacer-molds-fda-510k.jpg K240856 - Hip Spacer Molds K240856 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osartis GmbH. Cleared Nov 2024. https://www.510kdatabase.net/k241603/ 2024-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k241603-powered-wheelchair-nxn20-208-nxn20-211-fda-510k.jpg K241603 - Powered Wheelchair (NXN20-208, NXN20-211) K241603 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zhejiang Nysin Medical Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k241843/ 2024-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k241843-td-7301-spirometer-td-7301-fda-510k.jpg K241843 - TD-7301 Spirometer (TD-7301) K241843 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Gostar Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k242291/ 2024-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k242291-sol-m-luer-lock-syringe-low-dead-space-fda-510k.jpg K242291 - SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable Needle K242291 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sol-Millennium Medical, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k242359/ 2024-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k242359-strain-ai-sai001-fda-510k.jpg K242359 - Strain AI (SAI001) K242359 is a FDA 510(k) cleared radiology medical device. Manufacturer: Exo, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k242363/ 2024-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k242363-higherdose-red-light-hat-hg-120k-fda-510k.jpg K242363 - HIGHERDOSE Red Light Hat (HG-120K) K242363 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Kaiyan Medical Equipment Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k242517/ 2024-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k242517-proam-acdf-system-fda-510k.jpg K242517 - ProAM ACDF System K242517 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Pro Surgical, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k242520/ 2024-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k242520-element-vascular-access-system-fda-510k.jpg K242520 - Element Vascular Access System K242520 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Penumbra, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k242521/ 2024-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k242521-estar-ze-fda-510k.jpg K242521 - Estar-ZE K242521 is a FDA 510(k) cleared dental medical device. Manufacturer: Osstem Implant Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k243064/ 2024-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k243064-eterbio-fentanylnorfentanyl-rapid-test-fda-510k.jpg K243064 - ETERBIO Fentanyl/Norfentanyl Rapid Test (Colloidal Gold) K243064 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Eterbio, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k243164/ 2024-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k243164-indiba-compact-devices-fda-510k.jpg K243164 - INDIBA COMPACT devices K243164 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Indiba S. A. U.. Cleared Nov 2024. https://www.510kdatabase.net/k221349/ 2024-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k221349-xper-technology-premium-pro-blood-fda-510k.jpg K221349 - XPER Technology PREMIUM Pro Blood Glucose Monitoring System K221349 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Taidoc Technology Corporation. Cleared Nov 2024. https://www.510kdatabase.net/k221813/ 2024-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k221813-nova-allegro-uacr-assay-nova-allegro-fda-510k.jpg K221813 - Nova Allegro UACR Assay, Nova Allegro Analyzer K221813 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Nova Biomedical Corporation. Cleared Nov 2024. https://www.510kdatabase.net/k242028/ 2024-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k242028-nasal-aspirator-bc-021-bc-022-bc-023-fda-510k.jpg K242028 - Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026) K242028 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Dongguanshi Yiyingmei Technology Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k242102/ 2024-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k242102-cerrozone-mini-fda-510k.jpg K242102 - CerroZone Mini K242102 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cerrozone, LLC. Cleared Nov 2024. https://www.510kdatabase.net/k242293/ 2024-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k242293-medical-thulium-fiber-laser-systems-fda-510k.jpg K242293 - Medical Thulium Fiber Laser Systems (UroFiber 60Q) K242293 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Rhein Laser Technologies Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k242496/ 2024-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k242496-portable-liver-elastography-ultrasound-fda-510k.jpg K242496 - Portable Liver Elastography Ultrasound Diagnostic System (Liverscan C) K242496 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eieling Technology (Shenzhen) Limited. Cleared Nov 2024. https://www.510kdatabase.net/k242516/ 2024-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k242516-europa-posterior-cervical-fusion-system-fda-510k.jpg K242516 - EUROPA™ Posterior Cervical Fusion System K242516 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: MiRus, LLC. Cleared Nov 2024. https://www.510kdatabase.net/k242523/ 2024-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k242523-acuson-sequoia-diagnostic-ultrasound-fda-510k.jpg K242523 - ACUSON Sequoia Diagnostic Ultrasound System K242523 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k242930/ 2024-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k242930-natus-brainwatch-system-fda-510k.jpg K242930 - Natus BrainWatch System K242930 is a FDA 510(k) cleared neurology medical device. Manufacturer: Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). Cleared Nov 2024. https://www.510kdatabase.net/k243045/ 2024-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k243045-braxx-esophageal-brachytherapy-fda-510k.jpg K243045 - “BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002) K243045 is a FDA 510(k) cleared radiology medical device. Manufacturer: Braxx Biotech Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k243277/ 2024-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k243277-freedom-medial-congruent-liner-fda-510k.jpg K243277 - Freedom® Medial Congruent Liner K243277 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Maxx Orthopedics, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k243316/ 2024-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k243316-xenoview-30t-chest-coil-fda-510k.jpg K243316 - XENOVIEW 3.0T Chest Coil K243316 is a FDA 510(k) cleared radiology medical device. Manufacturer: Polarean, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k243323/ 2024-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k243323-iconix-knotless-anchor-fda-510k.jpg K243323 - Iconix Knotless Anchor K243323 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Riverpoint Medical. Cleared Nov 2024. https://www.510kdatabase.net/k240871/ 2024-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k240871-synxess-neurovascular-guidewire-fda-510k.jpg K240871 - Synxess Neurovascular Guidewire K240871 is a FDA 510(k) cleared neurology medical device. Manufacturer: Enlight Medical Technologies (Shenzhen) Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k241498/ 2024-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k241498-diode-laser-treatment-system-k18-fda-510k.jpg K241498 - Diode laser Treatment System (K18) K241498 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Hebei Keylaser Sci-Tech Co.,Ltd. Cleared Nov 2024. https://www.510kdatabase.net/k241633/ 2024-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k241633-informed-vital-core-application-ivc-app-fda-510k.jpg K241633 - Informed Vital Core Application (IVC App) K241633 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Mindset Medical, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k241700/ 2024-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k241700-tenex-2nd-generation-system-fda-510k.jpg K241700 - Tenex 2nd Generation System K241700 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Trice Medical, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k241747/ 2024-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k241747-saige-dx-fda-510k.jpg K241747 - Saige-Dx K241747 is a FDA 510(k) cleared radiology medical device. Manufacturer: DeepHealth, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k241814/ 2024-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k241814-da-vinci-sp-instruments-sp1098-fda-510k.jpg K241814 - da Vinci SP Instruments (SP1098) K241814 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k242092/ 2024-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k242092-micro-arterial-filters-fda-510k.jpg K242092 - MICRO Arterial Filters K242092 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sorin Group Italia S.R.L.. Cleared Nov 2024. https://www.510kdatabase.net/k242329/ 2024-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k242329-ct-collaboration-live-fda-510k.jpg K242329 - CT Collaboration Live K242329 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Healthcare (Suzhou) Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k242402/ 2024-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k242402-power-wheelchair-fda-510k.jpg K242402 - Power wheelchair K242402 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zhejiang Zhonglei Medical Technology Co. , Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k242471/ 2024-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k242471-power-wheelchair-w5538-fda-510k.jpg K242471 - Power Wheelchair (W5538) K242471 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zhejiang Innuovo Rehabilitation Devices Co.,Ltd. Cleared Nov 2024. https://www.510kdatabase.net/k243320/ 2024-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k243320-air-pressure-therapy-system-vu-ipc04b-fda-510k.jpg K243320 - Air Pressure Therapy System (VU-IPC04B) K243320 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Xiamen Weiyou Intelligent Technology Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k243506/ 2024-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k243506-montage-xt-settable-bone-putty-fda-510k.jpg K243506 - Montage-XT Settable Bone Putty K243506 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthocon, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k233081/ 2024-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k233081-nuventus-nvc-dental-implant-system-fda-510k.jpg K233081 - NUVENTUS NV.C™ Dental Implant System K233081 is a FDA 510(k) cleared dental medical device. Manufacturer: Infinitum Eta, Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k240523/ 2024-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k240523-vitavitro-single-lumen-oocyte-fda-510k.jpg K240523 - VitaVitro® Single Lumen Oocyte Retrieval Needle (ORNS-17G, ORNS-18G), VitaVitro® Double Lumen Oocyte Retrieval Needle (ORND-17G) K240523 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shenzhen Vitavitro Biotech Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k240528/ 2024-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k240528-b-one-total-hip-system-fda-510k.jpg K240528 - b-ONE® Total Hip System K240528 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: B-One Ortho, Corp.. Cleared Nov 2024. https://www.510kdatabase.net/k240860/ 2024-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k240860-echogo-amyloidosis-10-fda-510k.jpg K240860 - EchoGo Amyloidosis (1.0) K240860 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ultromics Limited. Cleared Nov 2024. https://www.510kdatabase.net/k241070/ 2024-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k241070-gelsoft-plus-vascular-prostheses-fda-510k.jpg K241070 - Gelsoft™ Plus Vascular Prostheses K241070 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vascutek, Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k241125/ 2024-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k241125-vivix-s-1751s-fda-510k.jpg K241125 - VIVIX-S 1751S K241125 is a FDA 510(k) cleared radiology medical device. Manufacturer: Vieworks Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k241138/ 2024-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k241138-artiseal-vessel-sealing-system-fda-510k.jpg K241138 - ArtiSeal Vessel Sealing System-ArtiSeal Instruments K241138 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Livsmed, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k241224/ 2024-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k241224-medline-renewal-reprocessed-biosense-fda-510k.jpg K241224 - Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Technology (BD710DF282CT, BD710DF282RTS, BD710FJ282RTS, BD710FJ282CT) K241224 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Surgical Instrument Service and Savings Inc.(Dba Medline Ren. Cleared Nov 2024. https://www.510kdatabase.net/k241439/ 2024-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k241439-vuno-med-chest-x-ray-triagevuno-med-fda-510k.jpg K241439 - VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage K241439 is a FDA 510(k) cleared radiology medical device. Manufacturer: Vuno, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k242062/ 2024-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k242062-1cmr-pro-fda-510k.jpg K242062 - 1CMR Pro K242062 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mycardium AI Limited. Cleared Nov 2024. https://www.510kdatabase.net/k242130/ 2024-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k242130-koios-ds-fda-510k.jpg K242130 - Koios DS K242130 is a FDA 510(k) cleared radiology medical device. Manufacturer: Koios Medical, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k242260/ 2024-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k242260-aprevo-cervical-acdf-fda-510k.jpg K242260 - aprevo® Cervical ACDF K242260 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Carlsmed, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k242272/ 2024-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k242272-coriograph-pre-op-planning-and-fda-510k.jpg K242272 - CORIOGRAPH Pre-Op Planning and Modeling Services K242272 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Blue Belt Technologies, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k242360/ 2024-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k242360-speedex-light-body-fda-510k.jpg K242360 - Speedex Light Body K242360 is a FDA 510(k) cleared dental medical device. Manufacturer: Dent4you AG. Cleared Nov 2024. https://www.510kdatabase.net/k242419/ 2024-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k242419-018-hydrophilic-coated-otw-pta-balloon-fda-510k.jpg K242419 - 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter K242419 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Creagh Medical Ltd. Dba Surmodics, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k242465/ 2024-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k242465-panther-fusion-sars-cov-2flu-abrsv-assay-fda-510k.jpg K242465 - Panther Fusion SARS-CoV-2/Flu A/B/RSV assay K242465 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Hologic, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k242800/ 2024-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k242800-the-5000-compact-series-ultrasound-fda-510k.jpg K242800 - The 5000 Compact Series Ultrasound Systems K242800 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Ultrasound, LLC. Cleared Nov 2024. https://www.510kdatabase.net/k242960/ 2024-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k242960-advance-xp-male-sling-system-720163-03-fda-510k.jpg K242960 - AdVance™ XP Male Sling System (720163-03) K242960 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Nov 2024. https://www.510kdatabase.net/k243285/ 2024-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k243285-tmini-miniature-robotic-system-fda-510k.jpg K243285 - TMINI Miniature Robotic System K243285 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: THINK Surgical, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k243299/ 2024-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k243299-acuson-redwood-diagnostic-ultrasound-fda-510k.jpg K243299 - ACUSON Redwood Diagnostic Ultrasound System K243299 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k243306/ 2024-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k243306-lancet-ia-ib-ic-id-ie-ik-il-im-iia-iib-fda-510k.jpg K243306 - Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX) K243306 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Tianjin Huahong Technology Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k241339/ 2024-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k241339-besmed-bacterial-filter-and-hmef-fda-510k.jpg K241339 - Besmed Bacterial Filter and HMEF K241339 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Besmed Health Business Corp. Cleared Nov 2024. https://www.510kdatabase.net/k241397/ 2024-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k241397-hinscope-fda-510k.jpg K241397 - Hinscope K241397 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hinlab Sas. Cleared Nov 2024. https://www.510kdatabase.net/k241930/ 2024-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k241930-veincare-fda-510k.jpg K241930 - Veincare K241930 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wontech Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k242079/ 2024-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k242079-arthrex-elbow-fracture-plating-system-fda-510k.jpg K242079 - Arthrex Elbow Fracture Plating System K242079 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k242342/ 2024-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k242342-fetal-echoscan-fda-510k.jpg K242342 - Fetal EchoScan K242342 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brightheart. Cleared Nov 2024. https://www.510kdatabase.net/k242436/ 2024-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k242436-proximal-humerus-fixation-system-fda-510k.jpg K242436 - Proximal Humerus Fixation System K242436 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Skeletal Dynamics, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k242440/ 2024-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k242440-intense-pulsed-light-treatment-system-fda-510k.jpg K242440 - Intense Pulsed Light Treatment System (LK-PT) K242440 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Nanjing Bestview Laser S&T Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k242598/ 2024-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k242598-define-system-ag612444a-fda-510k.jpg K242598 - DEFINE System (AG612444A) K242598 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Inmode , Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k242814/ 2024-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k242814-tandry-q-locking-plate-system-fda-510k.jpg K242814 - Tandry Q-Locking Plate System K242814 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Microware Precision Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k242940/ 2024-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k242940-xrecovery-xr-001-fda-510k.jpg K242940 - Xrecovery (XR-001) K242940 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Shenzhen Xinrun Electric Appliances Co, Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k211498/ 2024-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k211498-nonin-otc-pulse-oximeter-model-3250-fda-510k.jpg K211498 - Nonin OTC Pulse Oximeter Model 3250 K211498 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Nonin Medical, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k240337/ 2024-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k240337-dental-handpiece-model-j6-126-j6-136-fda-510k.jpg K240337 - Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L) K240337 is a FDA 510(k) cleared dental medical device. Manufacturer: Guangdong Jinme Medical Technology Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k241135/ 2024-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k241135-respondr-ventilator-fda-510k.jpg K241135 - RESPOND(R) Ventilator K241135 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Corvent Medical, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k242407/ 2024-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k242407-dental-glass-ceramics-blocks-ht-lt-mt-fda-510k.jpg K242407 - Dental Glass Ceramics Blocks (HT, LT, MT) K242407 is a FDA 510(k) cleared dental medical device. Manufacturer: Hunan Vsmile Biotechnology Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k242764/ 2024-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k242764-medirod-pedicle-screw-system-fda-510k.jpg K242764 - MediRod Pedicle Screw System K242764 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Cmf Medicon Surgical, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k242856/ 2024-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k242856-luofucon-silicone-ag-foam-dressing-fda-510k.jpg K242856 - LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer) K242856 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Huizhou Foryou Medical Devices Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k243273/ 2024-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k243273-cequr-simplicity-on-demand-insulin-fda-510k.jpg K243273 - CeQur Simplicity™ On-Demand Insulin Delivery System K243273 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Cequr SA. Cleared Nov 2024. https://www.510kdatabase.net/den240023/ 2024-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/den240023-smartflow-neuro-cannula-fda-510k.jpg DEN240023 - SmartFlow Neuro Cannula DEN240023 is a FDA 510(k) cleared neurology medical device. Manufacturer: ClearPoint Neuro, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k230915/ 2024-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k230915-airlife-open-et-oxygen-mask-airlife-fda-510k.jpg K230915 - AirLife™ Open Et Oxygen Mask, AirLife™ Open Et+ Oxygen Mask K230915 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Vyaire Medical, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k240771/ 2024-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k240771-prorad-x-ray-flat-panel-detector-with-fda-510k.jpg K240771 - PRORAD X-Ray Flat Panel Detector with DROC K240771 is a FDA 510(k) cleared radiology medical device. Manufacturer: Prognosys Medical Systems Private Limited. Cleared Nov 2024. https://www.510kdatabase.net/k241074/ 2024-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k241074-high-speed-air-turbine-handpieces-fda-510k.jpg K241074 - High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M) K241074 is a FDA 510(k) cleared dental medical device. Manufacturer: Foshan Soco Precision Instrument Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k241981/ 2024-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k241981-change-healthcare-stratus-imaging-pacs-fda-510k.jpg K241981 - Change Healthcare Stratus Imaging PACS K241981 is a FDA 510(k) cleared radiology medical device. Manufacturer: Change Healthcare Canada Company. Cleared Nov 2024. https://www.510kdatabase.net/k242018/ 2024-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k242018-ubiqvue-2a-multi-parameter-system-ux2550-fda-510k.jpg K242018 - UbiqVue™ 2A Multi-parameter System (UX2550) K242018 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Lifesignals, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k242173/ 2024-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k242173-retrace-ureteral-access-sheath-asxl10-fda-510k.jpg K242173 - Retrace Ureteral Access Sheath (ASXL10, ASXL12, ACXL10, ACXL12, AXXL10, AXXL12, ALXL10, ALXL12) K242173 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Coloplast Corp.. Cleared Nov 2024. https://www.510kdatabase.net/k242420/ 2024-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k242420-pnovus-21-microcatheter-fda-510k.jpg K242420 - pNOVUS 21 Microcatheter K242420 is a FDA 510(k) cleared neurology medical device. Manufacturer: Phenox, Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k242430/ 2024-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k242430-power-flex-pfx1214-fda-510k.jpg K242430 - Power-Flex (PFX1214) K242430 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Soul Mobility. Cleared Nov 2024. https://www.510kdatabase.net/k242502/ 2024-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k242502-aurelia-surgical-mask-astm-level-3-2130-fda-510k.jpg K242502 - Aurelia Surgical Mask ASTM Level-3 (2130) K242502 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Supermax Healthcare Canada-Supermax Medical. Cleared Nov 2024. https://www.510kdatabase.net/k242775/ 2024-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k242775-inpen-system-app-mmt-8060-ios-mmt-8061-fda-510k.jpg K242775 - InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) K242775 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Medtronic Minimed. Cleared Nov 2024. https://www.510kdatabase.net/k242791/ 2024-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k242791-electric-wheelchair-kr-8807-fda-510k.jpg K242791 - Electric wheelchair (KR-8807) K242791 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zhejiang Kairui Medical Device Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/den230085/ 2024-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/den230085-verify-resi-test-slide-thru-cleaning-fda-510k.jpg DEN230085 - VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator DEN230085 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Steris. Cleared Nov 2024. https://www.510kdatabase.net/k241575/ 2024-11-11 monthly 0.5 https://www.510kdatabase.net/og-image/k241575-straumann-anatomic-healing-abutments-fda-510k.jpg K241575 - Straumann® Anatomic Healing Abutments XC (AHA) K241575 is a FDA 510(k) cleared dental medical device. Manufacturer: Straumann USA, LLC. Cleared Nov 2024. https://www.510kdatabase.net/k243233/ 2024-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k243233-esolution-esophageal-retractor-fda-510k.jpg K243233 - esolution® Esophageal Retractor K243233 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: S4 Medical Corp.. Cleared Nov 2024. https://www.510kdatabase.net/k240417/ 2024-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k240417-profound-detection-v40-fda-510k.jpg K240417 - ProFound Detection (V4.0) K240417 is a FDA 510(k) cleared radiology medical device. Manufacturer: Icad, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k240510/ 2024-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k240510-microdacyn-hydrogel-fda-510k.jpg K240510 - Microdacyn Hydrogel K240510 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sonoma Pharmaceuticals, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k240794/ 2024-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k240794-frontier-x-plus-fda-510k.jpg K240794 - Frontier X Plus K240794 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Fourth Frontier Technologies Pvt, Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k241099/ 2024-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k241099-plasonic-plasonic-fda-510k.jpg K241099 - Plasonic (Plasonic) K241099 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Hironic Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k241342/ 2024-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k241342-hair-growth-comb-sz-23sz-23a-fda-510k.jpg K241342 - Hair Growth Comb (SZ-23,SZ-23A) K241342 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Nuon Medical Equipment Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k241364/ 2024-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k241364-hybrid-viewer-00859873006189-fda-510k.jpg K241364 - Hybrid Viewer (00859873006189) K241364 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hermes Medical Solutions AB. Cleared Nov 2024. https://www.510kdatabase.net/k241636/ 2024-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k241636-mobilelink-acetabular-cup-system-line-fda-510k.jpg K241636 - MobileLink Acetabular Cup System - Line Extension (Multiple) K241636 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Waldemar Link GmbH & Co. KG. Cleared Nov 2024. https://www.510kdatabase.net/k241802/ 2024-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k241802-device-300397-putty-fda-510k.jpg K241802 - Device 300397 Putty K241802 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Geistlich Pharma AG. Cleared Nov 2024. https://www.510kdatabase.net/k242231/ 2024-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k242231-resona-a10s-resona-a20-pro-resona-a20t-fda-510k.jpg K242231 - Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System K242231 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k242286/ 2024-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k242286-superflow-prime-treatment-system-asp-1m-fda-510k.jpg K242286 - Superflow Prime Treatment System (ASP-1M) K242286 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Guangzhou Aimira Innovation Technology Co, Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k242382/ 2024-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k242382-dcolite-led-device-fda-510k.jpg K242382 - décoLITE LED Device K242382 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: iSMART Developments, Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k242749/ 2024-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k242749-topcem-ceramic-primer-ceramic-coupling-fda-510k.jpg K242749 - TopCEM Ceramic Primer Ceramic Coupling Agent K242749 is a FDA 510(k) cleared dental medical device. Manufacturer: Rizhao Huge Biomaterials Company, Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k242756/ 2024-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k242756-introducer-sheath-pflexi00l065-fda-510k.jpg K242756 - Introducer Sheath (PFlexi00L065, PFlexi00L070, PFlexi00L075, PFlexi00L080, PFlexi00L090, PFlexi30L065, PFlexi30L070, PFlexi30L075, PFlexi30L080, PFlexi30L090, PFlexi45L065, PFlexi45L070, PFlexi45L075, PFlexi45L080, PFlexi45L090, PFlexi60L065, PFlexi60L070, PFlexi60L075, PFlexi60L080, PFlexi60L090) K242756 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Pulnovo Medical (Wuxi) Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k242802/ 2024-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k242802-clungene-fentanyl-home-test-cassette-fda-510k.jpg K242802 - CLUNGENE Fentanyl Home Test Cassette K242802 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Hangzhou Clongene Biotech Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k243004/ 2024-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k243004-xpine-spinal-fixation-system-fda-510k.jpg K243004 - Xpine Spinal Fixation System K243004 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Jeil Medical Corporation. Cleared Nov 2024. https://www.510kdatabase.net/k243075/ 2024-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k243075-defendo-single-use-cleaning-adapter-fda-510k.jpg K243075 - Defendo Single Use Cleaning Adapter for Olympus Endoscopes (100322, 100323, 4000096, 4003269, 4003280) K243075 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: STERIS Corporation. Cleared Nov 2024. https://www.510kdatabase.net/k243231/ 2024-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k243231-trigon-peek-ha-wedges-fda-510k.jpg K243231 - Trigon PEEK HA Wedges K243231 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nvision Biomedical Technologies. Cleared Nov 2024. https://www.510kdatabase.net/k212425/ 2024-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k212425-microtrend-system-fda-510k.jpg K212425 - MicroTrend System K212425 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Exostat Medical, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k240415/ 2024-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k240415-newclip-patient-matched-fda-510k.jpg K240415 - Newclip Patient-matched instrumentation non sterile PSI K240415 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Newclip Technics. Cleared Nov 2024. https://www.510kdatabase.net/k240429/ 2024-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k240429-trilogy-tissue-marker-fda-510k.jpg K240429 - Trilogy Tissue Marker K240429 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Inrad, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k240712/ 2024-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k240712-icobrain-aria-fda-510k.jpg K240712 - icobrain aria K240712 is a FDA 510(k) cleared radiology medical device. Manufacturer: Icometrix NV. Cleared Nov 2024. https://www.510kdatabase.net/k241346/ 2024-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k241346-iodr1717-iodr1417-iodr1417-gf-digital-fda-510k.jpg K241346 - IODR1717 / IODR1417 / IODR1417-GF (Digital Flat Panel X-ray Detector) K241346 is a FDA 510(k) cleared radiology medical device. Manufacturer: Aspen Imaging Healthcare, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k241468/ 2024-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k241468-vertiwedge-intraosseous-system-fda-510k.jpg K241468 - Vertiwedge® Intraosseous System K241468 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Foundation Surgical Group, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k241719/ 2024-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k241719-neuroich-fda-510k.jpg K241719 - NeuroICH K241719 is a FDA 510(k) cleared radiology medical device. Manufacturer: Neurocareai, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k241853/ 2024-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k241853-titanium-fletcher-style-applicator-set-fda-510k.jpg K241853 - Titanium Fletcher-Style Applicator Set Defined Geometry K241853 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k241872/ 2024-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k241872-remanufactured-endowrist-prograsp-fda-510k.jpg K241872 - Remanufactured EndoWrist ProGrasp Forceps (420093) K241872 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Rebotix. Cleared Nov 2024. https://www.510kdatabase.net/k242361/ 2024-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k242361-ozark-cervical-plate-system-fda-510k.jpg K242361 - OZARK Cervical Plate System K242361 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Spine. Cleared Nov 2024. https://www.510kdatabase.net/k242367/ 2024-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k242367-biofire-filmarray-gastrointestinal-gi-fda-510k.jpg K242367 - BIOFIRE FILMARRAY Gastrointestinal (GI) Panel K242367 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Biofire Diagnostics, LLC. Cleared Nov 2024. https://www.510kdatabase.net/k242373/ 2024-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k242373-mako-shoulder-application-10-fda-510k.jpg K242373 - Mako Shoulder Application (1.0) K242373 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Mako Surgical Corp.. Cleared Nov 2024. https://www.510kdatabase.net/k242379/ 2024-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k242379-ll-implant-system-fda-510k.jpg K242379 - LL Implant System K242379 is a FDA 510(k) cleared dental medical device. Manufacturer: Ossvis Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k242595/ 2024-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k242595-intense-pulse-light-therapeutic-fda-510k.jpg K242595 - Intense Pulse Light Therapeutic Apparatus (IPL-18 BF, IPL-18 FG) K242595 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Greatro Electronic Technology Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k242702/ 2024-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k242702-vioseal-fda-510k.jpg K242702 - VioSeal K242702 is a FDA 510(k) cleared dental medical device. Manufacturer: Spident Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k242734/ 2024-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k242734-zsfab-cervical-interbody-system-fda-510k.jpg K242734 - ZSFab Cervical Interbody System K242734 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zsfab. Cleared Nov 2024. https://www.510kdatabase.net/k240450/ 2024-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k240450-citrepore-fda-510k.jpg K240450 - Citrepore™ K240450 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Acuitive Technologies, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k240831/ 2024-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k240831-multicut-solo-fda-510k.jpg K240831 - MultiCut Solo K240831 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Asclepion Laser Technologies GmbH. Cleared Nov 2024. https://www.510kdatabase.net/k240997/ 2024-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k240997-hi-torque-command-14-st-guide-wire-and-fda-510k.jpg K240997 - Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire K240997 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared Nov 2024. https://www.510kdatabase.net/k242039/ 2024-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k242039-ice-cooling-ipl-hair-removal-device-fda-510k.jpg K242039 - Ice Cooling IPL Hair Removal Device (UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR) K242039 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Ulike Smart Electronics Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k242261/ 2024-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k242261-accelx-implant-system-fda-510k.jpg K242261 - Accelx Implant System K242261 is a FDA 510(k) cleared dental medical device. Manufacturer: Biotech Dental, LLC. Cleared Nov 2024. https://www.510kdatabase.net/k242412/ 2024-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k242412-agility-symmetric-total-knee-system-fda-510k.jpg K242412 - Agility Symmetric™ Total Knee System K242412 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medisurge, LLC. Cleared Nov 2024. https://www.510kdatabase.net/k242719/ 2024-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k242719-elexir-20-allive3-fda-510k.jpg K242719 - ELEXIR 2.0 (ALLIVE3) K242719 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nu Eyne Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k242803/ 2024-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k242803-compound-w-skin-tag-remover-fda-510k.jpg K242803 - Compound W Skin Tag Remover K242803 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medtech Products, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k243222/ 2024-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k243222-biofire-filmarray-pneumonia-panel-fda-510k.jpg K243222 - BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel) K243222 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Biofire Diagnostics, LLC (Biomerieux). Cleared Nov 2024. https://www.510kdatabase.net/k231287/ 2024-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k231287-potenza-fda-510k.jpg K231287 - POTENZA K231287 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Jeisys Medical, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k240624/ 2024-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k240624-infulife-fda-510k.jpg K240624 - InfuLife K240624 is a FDA 510(k) cleared general hospital medical device. Manufacturer: First Medical Source, LLC. Cleared Nov 2024. https://www.510kdatabase.net/k241312/ 2024-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k241312-terarecon-cardiacchambersmr-100-fda-510k.jpg K241312 - TeraRecon Cardiac.Chambers.MR (1.0.0) K241312 is a FDA 510(k) cleared radiology medical device. Manufacturer: Terarecon,Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k241484/ 2024-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k241484-atlas-humeral-nail-system-fda-510k.jpg K241484 - Atlas™ Humeral Nail System K241484 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthopedic Designs North America, Inc. (Odi-Na). Cleared Nov 2024. https://www.510kdatabase.net/k241849/ 2024-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k241849-medrad-centargo-ct-injection-system-fda-510k.jpg K241849 - MEDRAD Centargo CT Injection System K241849 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Imaxeon Pty, Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k242332/ 2024-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k242332-transcutaneous-electronic-nerve-fda-510k.jpg K242332 - Transcutaneous Electronic Nerve Stimulator (KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2491, KTR-2492, KTR-2493, KTR-2494) K242332 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Kentro Medical Electronics Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k242340/ 2024-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k242340-dess-dental-smart-solutions-fda-510k.jpg K242340 - DESS Dental Smart Solutions K242340 is a FDA 510(k) cleared dental medical device. Manufacturer: Terrats Medical SL. Cleared Nov 2024. https://www.510kdatabase.net/k242345/ 2024-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k242345-delphi-stimulator-fda-510k.jpg K242345 - Delphi Stimulator K242345 is a FDA 510(k) cleared neurology medical device. Manufacturer: Quantalx Neuroscience. Cleared Nov 2024. https://www.510kdatabase.net/k242664/ 2024-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k242664-gentleheel-adult-incision-device-fda-510k.jpg K242664 - gentleheel® Adult Incision Device K242664 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Gri-Alleset, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k242947/ 2024-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k242947-freedomflow-orbital-circumferential-fda-510k.jpg K242947 - FreedomFlow™ Orbital Circumferential Atherectomy System K242947 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cardio Flow Inc.,. Cleared Nov 2024. https://www.510kdatabase.net/k243015/ 2024-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k243015-skyway-anterior-cervical-plate-system-fda-510k.jpg K243015 - Skyway Anterior Cervical Plate System K243015 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Kyocera Medical Technologies, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k243106/ 2024-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k243106-carboclear-hybrid-pedicle-screw-system-fda-510k.jpg K243106 - CarboClear® Hybrid Pedicle Screw System K243106 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: CarboFix Orthopedics , Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k240438/ 2024-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k240438-cdb-hospital-sterilization-wrap-70-gsm-fda-510k.jpg K240438 - CDB Hospital ® Sterilization Wrap (70 gsm) K240438 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Comercializadora Brever. Cleared Nov 2024. https://www.510kdatabase.net/k240512/ 2024-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k240512-tixel-i-txli0001-fda-510k.jpg K240512 - Tixel i (TXLI0001) K240512 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Novoxel , Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k240637/ 2024-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k240637-rightest-blood-glucose-monitoring-fda-510k.jpg K240637 - RIGHTEST Blood Glucose Monitoring System Max Tel K240637 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bionime Corporation. Cleared Nov 2024. https://www.510kdatabase.net/k242195/ 2024-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k242195-gemini-cervical-fusion-cage-system-fda-510k.jpg K242195 - Gemini Cervical Fusion Cage System K242195 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: ZheJiang Decans Medical Devices Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k242567/ 2024-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k242567-muscle-and-nerve-stimulator-tens-ems-fda-510k.jpg K242567 - Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TENS & EMS (TP2208C) K242567 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Changsha Anxiang Medical Technology Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k242709/ 2024-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k242709-jlk-pwi-fda-510k.jpg K242709 - JLK-PWI K242709 is a FDA 510(k) cleared radiology medical device. Manufacturer: JLK, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k243061/ 2024-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k243061-sonostik-guide-wire-introducer-fda-510k.jpg K243061 - SonoStik Guide Wire Introducer K243061 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sonostik, LLC. Cleared Nov 2024. https://www.510kdatabase.net/den230083/ 2024-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/den230083-valeda-light-delivery-system-fda-510k.jpg DEN230083 - Valeda Light Delivery System DEN230083 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Lumithera, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k240366/ 2024-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k240366-epxt-unidirectional-steerable-fda-510k.jpg K240366 - EP•XT™ Unidirectional Steerable Diagnostic Catheter K240366 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Nov 2024. https://www.510kdatabase.net/k240388/ 2024-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k240388-osteotomy-truss-system-ots-fda-510k.jpg K240388 - Osteotomy Truss System (OTS) K240388 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 4Web Medical, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k240514/ 2024-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k240514-amt-low-profile-suprapubic-catheter-fda-510k.jpg K240514 - AMT Low-Profile Suprapubic Catheter & Drainage Set K240514 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Applied Medical Technology, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k240881/ 2024-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k240881-signia-circular-adapter-standard-fda-510k.jpg K240881 - Signia™ Circular Adapter (Standard Length) (SIGCIRSTND) K240881 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien (Part of Medtronic). Cleared Nov 2024. https://www.510kdatabase.net/k241068/ 2024-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k241068-udr-780i-fda-510k.jpg K241068 - uDR 780i K241068 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k241646/ 2024-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k241646-ortiv-ortiv-bl-ortiv-wh-fda-510k.jpg K241646 - ORTIV (ORTIV-BL, ORTIV-WH) K241646 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Mvitro Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k241828/ 2024-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k241828-affera-integrated-mapping-system-fda-510k.jpg K241828 - Affera Integrated Mapping System K241828 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k241999/ 2024-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k241999-prophecy-surgical-planning-system-fda-510k.jpg K241999 - Prophecy Surgical Planning System K241999 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wright Medical Technology, Inc. (Stryker). Cleared Nov 2024. https://www.510kdatabase.net/k242076/ 2024-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k242076-versacross-rf-wire-fda-510k.jpg K242076 - VersaCross™ RF Wire K242076 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baylis Medical Company. Cleared Nov 2024. https://www.510kdatabase.net/k242269/ 2024-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k242269-sc-hemodialysis-device-sc-14269-fda-510k.jpg K242269 - SC+ Hemodialysis Device (SC-14269) K242269 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quanta Dialysis Technologies, Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k242311/ 2024-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k242311-expert-flexible-joint-fixation-system-fda-510k.jpg K242311 - EXPERT - Flexible Joint Fixation System K242311 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: GM Dos Reis Industria e Comercio Ltda.. Cleared Nov 2024. https://www.510kdatabase.net/k242320/ 2024-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k242320-bd-vacutainer-one-use-holder-fda-510k.jpg K242320 - BD Vacutainer® One Use Holder K242320 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson and Company. Cleared Nov 2024. https://www.510kdatabase.net/k242393/ 2024-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k242393-acuity-181-tisilfocon-a-and-acuity-181-fda-510k.jpg K242393 - Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses K242393 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Acuity Polymers, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k242452/ 2024-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k242452-monkey-bars-pin-to-bar-external-fda-510k.jpg K242452 - Monkey Bars Pin to Bar External Fixation System K242452 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paragon 28, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k242591/ 2024-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k242591-xero-alpha-fda-510k.jpg K242591 - XERO-alpha K242591 is a FDA 510(k) cleared radiology medical device. Manufacturer: DRTECH Corporation. Cleared Nov 2024. https://www.510kdatabase.net/k242620/ 2024-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k242620-breo-laser-hair-growth-comb-scalp-3l-fda-510k.jpg K242620 - Breo Laser Hair Growth Comb (Scalp 3L) K242620 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Breo Technology Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k242665/ 2024-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k242665-depuy-attune-total-knee-system-fda-510k.jpg K242665 - DePuy ATTUNE™ Total Knee System K242665 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Orthopedics, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k242675/ 2024-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k242675-fineetch-fineetch-10-12ml-fineetch-10-fda-510k.jpg K242675 - FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack) K242675 is a FDA 510(k) cleared dental medical device. Manufacturer: Spident Co., Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k243091/ 2024-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k243091-over-tube-tr-1108a-fda-510k.jpg K243091 - Over-tube (TR-1108A) K243091 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fujifilm Corporation. Cleared Nov 2024. https://www.510kdatabase.net/k243217/ 2024-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k243217-legend-x-desktop-system-fda-510k.jpg K243217 - Legend X Desktop System K243217 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Pollogen, Ltd.. Cleared Nov 2024. https://www.510kdatabase.net/k243381/ 2024-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k243381-total-wrist-arthroplasty-system-twa-fda-510k.jpg K243381 - Total Wrist Arthroplasty System (TWA) K243381 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Skeletal Dynamics, Inc.. Cleared Nov 2024. https://www.510kdatabase.net/k240375/ 2024-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k240375-v80-anesthetic-vaporizer-v80-fda-510k.jpg K240375 - V80 Anesthetic Vaporizer (V80) K240375 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k240383/ 2024-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k240383-highness-implant-system-fda-510k.jpg K240383 - Highness Implant System K240383 is a FDA 510(k) cleared dental medical device. Manufacturer: Highness Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k240455/ 2024-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k240455-bd-vacutainer-citrate-blood-collection-fda-510k.jpg K240455 - BD Vacutainer® Citrate Blood Collection Tubes K240455 is a FDA 510(k) cleared hematology medical device. Manufacturer: Becton, Dickinson and Company. Cleared Oct 2024. https://www.510kdatabase.net/k240653/ 2024-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k240653-smartcardia-7l-platform-mct-fda-510k.jpg K240653 - SmartCardia 7L Platform (MCT) K240653 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Smartcardia SA. Cleared Oct 2024. https://www.510kdatabase.net/k241223/ 2024-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k241223-erad-pacs-fda-510k.jpg K241223 - eRAD PACS K241223 is a FDA 510(k) cleared radiology medical device. Manufacturer: Erad, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k242328/ 2024-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k242328-powerport-clearvue-slim-implantable-fda-510k.jpg K242328 - PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implantable Ports K242328 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bard Access Systems, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k242399/ 2024-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k242399-bonebridge-osteosynthesis-plating-system-fda-510k.jpg K242399 - Bonebridge Osteosynthesis Plating System K242399 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Bonebridge AG. Cleared Oct 2024. https://www.510kdatabase.net/k242623/ 2024-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k242623-disposable-blood-pressure-cuff-fda-510k.jpg K242623 - Disposable Blood Pressure cuff K242623 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Medke Technology Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k243181/ 2024-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k243181-foundation-dermal-regeneration-fda-510k.jpg K243181 - Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo K243181 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bionova Medical, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k240177/ 2024-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k240177-zio-at-device-a100a1001-fda-510k.jpg K240177 - Zio AT® device (A100A1001) K240177 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: iRhythm Technologies, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k240333/ 2024-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k240333-wearable-digital-thermometer-t31-fda-510k.jpg K240333 - Wearable Digital Thermometer (T31) K240333 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guangdong Genial Technology Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k240334/ 2024-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k240334-lagis-endoscopic-instruments-grasper-fda-510k.jpg K240334 - LAGIS Endoscopic Instruments - Grasper (DI-5670-33D, DI-5670-45D, DI-5716-33D, DI-5716-45D, DI-5719-33D, DI-5731-33D, DI-5731-45D, DI-5901-33D, DI-5901-45D) K240334 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lagis Enterprise Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k240560/ 2024-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k240560-zenex-implant-systemlong-fda-510k.jpg K240560 - ZENEX Implant System_Long K240560 is a FDA 510(k) cleared dental medical device. Manufacturer: Izenimplant Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k240670/ 2024-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k240670-dri-ecstasy-plus-assay-fda-510k.jpg K240670 - DRI Ecstasy Plus Assay K240670 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Microgenics Corporation. Cleared Oct 2024. https://www.510kdatabase.net/k240847/ 2024-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k240847-medicco2lon-medicco2lon-fda-510k.jpg K240847 - MedicCO2LON (MedicCO2LON) K240847 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ide Vision, Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k241108/ 2024-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k241108-remedylogic-ai-mri-lumbar-spine-reader-fda-510k.jpg K241108 - RemedyLogic AI MRI Lumbar Spine Reader K241108 is a FDA 510(k) cleared radiology medical device. Manufacturer: Remedy Logic, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k241533/ 2024-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k241533-neuraxis-ib-stim-01-1020-fda-510k.jpg K241533 - NeurAxis IB-Stim (01-1020) K241533 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Neuraxis. Cleared Oct 2024. https://www.510kdatabase.net/k241902/ 2024-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k241902-edison-system-fda-510k.jpg K241902 - Edison System K241902 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: HistoSonics, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k242271/ 2024-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k242271-caduceus-s-fda-510k.jpg K242271 - Caduceus S K242271 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Taiwan Main Orthopaedic Biotechnology Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k242627/ 2024-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k242627-safety-lancet-fda-510k.jpg K242627 - Safety Lancet K242627 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ningbo Medsun Medical Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k242711/ 2024-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k242711-journey-ii-unicompartmental-knee-fda-510k.jpg K242711 - JOURNEY II Unicompartmental Knee System (JOURNEY II UK) K242711 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k243186/ 2024-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k243186-symbia-prospecta-q3-11364751-fda-510k.jpg K243186 - Symbia Pro.specta Q3 (11364751) K243186 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/den230082/ 2024-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/den230082-stone-clear-sc-lp9-01-fda-510k.jpg DEN230082 - Stone Clear (SC-LP9-01) DEN230082 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Sonomotion, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k240175/ 2024-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k240175-tigon-medical-fractures-instability-fda-510k.jpg K240175 - Tigon Medical Fractures, Instability, and Reconstruction (FIRE) K240175 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tigon Medical. Cleared Oct 2024. https://www.510kdatabase.net/k241077/ 2024-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k241077-degen-medical-patient-specific-implant-fda-510k.jpg K241077 - DeGen Medical Patient Specific Implant (PSI) System K241077 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Degen Medical. Cleared Oct 2024. https://www.510kdatabase.net/k241189/ 2024-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k241189-electric-wheelchair-me23-ew16-bc200-01-fda-510k.jpg K241189 - Electric Wheelchair (ME23-EW16-BC200-01) K241189 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Jiaxing Xiaoxiang Medical Equipment Technology Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k241366/ 2024-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k241366-qualityflow-o2-series-qualityflow-o2-fda-510k.jpg K241366 - QualityFlow O2 Series (QualityFLOW O2) K241366 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Dehas Medical Systems GmbH. Cleared Oct 2024. https://www.510kdatabase.net/k241612/ 2024-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k241612-video-bronchoscope-system-fda-510k.jpg K241612 - Video Bronchoscope System K241612 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Hunan Vathin Medical Instrument Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k241965/ 2024-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k241965-catheter-surface-flap-applicator-set-fda-510k.jpg K241965 - Catheter Surface Flap Applicator Set (GM11011830) K241965 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems. Cleared Oct 2024. https://www.510kdatabase.net/k242256/ 2024-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k242256-qiastat-dx-meningitisencephalitis-me-fda-510k.jpg K242256 - QIAstat-Dx Meningitis/Encephalitis (ME) Panel K242256 is a FDA 510(k) cleared microbiology medical device. Manufacturer: QIAGEN GmbH. Cleared Oct 2024. https://www.510kdatabase.net/k243080/ 2024-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k243080-riptide-aspiration-system-fda-510k.jpg K243080 - Riptide Aspiration System K243080 is a FDA 510(k) cleared neurology medical device. Manufacturer: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. Cleared Oct 2024. https://www.510kdatabase.net/k243095/ 2024-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k243095-mammotome-autocore-single-insertion-fda-510k.jpg K243095 - Mammotome AutoCore™ Single Insertion Core Biopsy System K243095 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Devicor Medical Products, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k243126/ 2024-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k243126-tracheobronxane-dumon-fda-510k.jpg K243126 - TRACHEOBRONXANE™ DUMON® K243126 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Novatech SA. Cleared Oct 2024. https://www.510kdatabase.net/k243157/ 2024-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k243157-atricure-cryoice-box-acm-fda-510k.jpg K243157 - AtriCure cryoICE BOX (ACM) K243157 is a FDA 510(k) cleared neurology medical device. Manufacturer: AtriCure, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k243203/ 2024-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k243203-oc-juggerknotless-soft-anchor-fda-510k.jpg K243203 - OC JuggerKnotless Soft Anchor K243203 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Riverpoint Medical. Cleared Oct 2024. https://www.510kdatabase.net/k243247/ 2024-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k243247-persona-the-personalized-knee-system-fda-510k.jpg K243247 - Persona the Personalized Knee System K243247 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k240303/ 2024-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k240303-metalite-dx-digital-pathology-software-fda-510k.jpg K240303 - MetaLite DX Digital Pathology Software K240303 is a FDA 510(k) cleared pathology medical device. Manufacturer: Jellox Biotech, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k241630/ 2024-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k241630-echelon-4000-60mm-compact-stapler-fda-510k.jpg K241630 - ECHELON 4000 60mm Compact Stapler (EC3D60C) K241630 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon Endo-Surgery, LLC. Cleared Oct 2024. https://www.510kdatabase.net/k241718/ 2024-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k241718-micro-current-facial-beauty-device-am-fda-510k.jpg K241718 - Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) K241718 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Aozemei Technology Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k241992/ 2024-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k241992-catalyft-ls-expandable-interbody-system-fda-510k.jpg K241992 - Catalyft™ LS Expandable Interbody System K241992 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k242350/ 2024-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k242350-spinal-alignment-solutions-pelvic-fda-510k.jpg K242350 - Spinal Alignment Solutions Pelvic Incidence (PI) Rod System K242350 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinal Alignment Solutions, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k242622/ 2024-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k242622-sterile-lancets-for-single-use-fda-510k.jpg K242622 - Sterile Lancets for Single Use K242622 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ningbo Caremed Medical Products Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k243137/ 2024-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k243137-curiteva-porous-peek-laminoplasty-system-fda-510k.jpg K243137 - Curiteva Porous PEEK Laminoplasty System K243137 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Curiteva, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k240040/ 2024-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k240040-vistapano-s-ceph-20-vistapano-s-ceph-fda-510k.jpg K240040 - VistaPano S Ceph 2.0 (VistaPano S Ceph) K240040 is a FDA 510(k) cleared radiology medical device. Manufacturer: VATECH Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k240092/ 2024-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k240092-pulse-oximeter-ym101-ym102-ym103-ym104-fda-510k.jpg K240092 - Pulse Oximeter (YM101, YM102, YM103, YM104, YM201, YM301, YM202, YM302, YM111, YM112, YM113, YM114, YM211, YM212, YM314, YM601, YM602, YM401, YM402, YM403, YM501, YM502, YM503 and YM504) K240092 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Yimi Life-Technology Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k240223/ 2024-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k240223-fmt-disposable-and-autoclavable-fda-510k.jpg K240223 - FMT Disposable and Autoclavable Temperature Probes K240223 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Metko Medikal VE Tibbi Cihazlar Dis Ticaret Limited Sirketi. Cleared Oct 2024. https://www.510kdatabase.net/k240269/ 2024-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k240269-nitrile-powder-free-examination-gloves-fda-510k.jpg K240269 - Nitrile Powder Free Examination Gloves Biodegradable (Green) K240269 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Comfort Rubber Gloves Industries Sdn. Bhd.. Cleared Oct 2024. https://www.510kdatabase.net/k240918/ 2024-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k240918-deseyne-vifilcon-c-daily-disposable-fda-510k.jpg K240918 - Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Myopia and Hyperopia K240918 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Bruno Vision Care, LLC. Cleared Oct 2024. https://www.510kdatabase.net/k241185/ 2024-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k241185-corgrip-sr-ngni-tube-retention-system-fda-510k.jpg K241185 - CORGRIP* SR NG/NI Tube Retention System K241185 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Avanos Medical, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k242215/ 2024-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k242215-neurophet-aqua-v31-fda-510k.jpg K242215 - Neurophet AQUA (V3.1) K242215 is a FDA 510(k) cleared radiology medical device. Manufacturer: Neurophet., Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k242353/ 2024-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k242353-qiastat-dx-respiratory-panel-mini-fda-510k.jpg K242353 - QIAstat-Dx Respiratory Panel Mini K242353 is a FDA 510(k) cleared microbiology medical device. Manufacturer: QIAGEN GmbH. Cleared Oct 2024. https://www.510kdatabase.net/k242397/ 2024-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k242397-lynx-photocoagulator-fda-510k.jpg K242397 - LYNX Photocoagulator K242397 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Norlase Aps. Cleared Oct 2024. https://www.510kdatabase.net/k242625/ 2024-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k242625-freeze-point-private-label-versions-fda-510k.jpg K242625 - Freeze Point & Private Label Versions K242625 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cryoconcepts LP. Cleared Oct 2024. https://www.510kdatabase.net/k242956/ 2024-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k242956-lds-needle-fda-510k.jpg K242956 - LDS Needle K242956 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ocuject, LLC. Cleared Oct 2024. https://www.510kdatabase.net/k242969/ 2024-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k242969-pantera-pro-fda-510k.jpg K242969 - Pantera Pro K242969 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biotronik, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k242984/ 2024-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k242984-bks-revision-system-fda-510k.jpg K242984 - BKS Revision System K242984 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ortho Development Corp.. Cleared Oct 2024. https://www.510kdatabase.net/k243030/ 2024-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k243030-diamond-air-ui04a-ui04b-ui04c-ui04m-fda-510k.jpg K243030 - Diamond Air+ (UI04A, UI04B, UI04C, UI04M, UI04G, UI04W) K243030 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ulike Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k243031/ 2024-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k243031-lcd-monitors-c310s-g310s-c316s-g316s-fda-510k.jpg K243031 - LCD Monitors C310S, G310S, C316S, G316S, C616W K243031 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Beacon Display Technology Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k243070/ 2024-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k243070-xpert-sa-nasal-complete-fda-510k.jpg K243070 - Xpert® SA Nasal Complete K243070 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Cepheid. Cleared Oct 2024. https://www.510kdatabase.net/k243173/ 2024-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k243173-salto-talaris-ankle-psi-system-fda-510k.jpg K243173 - Salto Talaris Ankle PSI System K243173 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 3D Systems, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k243174/ 2024-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k243174-cadence-ankle-psi-system-fda-510k.jpg K243174 - Cadence Ankle PSI System K243174 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 3D Systems, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k243189/ 2024-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k243189-tumorsight-viz-fda-510k.jpg K243189 - TumorSight Viz K243189 is a FDA 510(k) cleared radiology medical device. Manufacturer: SimBioSys, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/den230084/ 2024-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/den230084-dexter-l6-system-fda-510k.jpg DEN230084 - Dexter L6 System DEN230084 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Distalmotion SA. Cleared Oct 2024. https://www.510kdatabase.net/k240391/ 2024-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k240391-mutars-femoral-stem-cemented-160-mm-fda-510k.jpg K240391 - MUTARS® femoral stem cemented 160 mm and 200 mm K240391 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Implantcast GmbH. Cleared Oct 2024. https://www.510kdatabase.net/k240543/ 2024-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k240543-rapido-medical-laser-rapido-med-rapido-fda-510k.jpg K240543 - Rapido Medical Laser (Rapido MED, Rapido Derma, Rapido ENT, Rapido Podia) K240543 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medency S.R.L.. Cleared Oct 2024. https://www.510kdatabase.net/k241007/ 2024-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k241007-upper-arm-electronic-blood-pressure-fda-510k.jpg K241007 - Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01) K241007 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Urion Technology Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k241089/ 2024-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k241089-keyprint-keydenture-base-fda-510k.jpg K241089 - KeyPrint KeyDenture Base K241089 is a FDA 510(k) cleared dental medical device. Manufacturer: Keystone Industries. Cleared Oct 2024. https://www.510kdatabase.net/k241554/ 2024-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k241554-portable-digital-color-doppler-fda-510k.jpg K241554 - Portable Digital Color Doppler Ultrasound System (SCN201D, SCN201L) K241554 is a FDA 510(k) cleared radiology medical device. Manufacturer: Telefield Medical Imaging (Shenzhen) Limited. Cleared Oct 2024. https://www.510kdatabase.net/k242034/ 2024-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k242034-duet-external-drainage-and-monitoring-fda-510k.jpg K242034 - Duet External Drainage and Monitoring System (EDMS) K242034 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Neurosurgery. Cleared Oct 2024. https://www.510kdatabase.net/k242086/ 2024-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k242086-magdi-system-mag-01-ds-01-fda-510k.jpg K242086 - MagDI System (MAG-01, DS-01) K242086 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Gt Metabolic Solutions, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k242458/ 2024-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k242458-argenz-mtz-fda-510k.jpg K242458 - ArgenZ MTZ K242458 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Corporation. Cleared Oct 2024. https://www.510kdatabase.net/k242462/ 2024-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k242462-cerec-cercon-4d-cadcam-blocks-fda-510k.jpg K242462 - CEREC Cercon 4D CAD/CAM Blocks K242462 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona. Cleared Oct 2024. https://www.510kdatabase.net/k242512/ 2024-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k242512-rocc-console-fda-510k.jpg K242512 - ROCC Console K242512 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Oct 2024. https://www.510kdatabase.net/k242560/ 2024-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k242560-manual-wheelchair-syiv100-ca9221-fda-510k.jpg K242560 - Manual Wheelchair (SYIV100-CA9221) K242560 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Foshan Shunkangda Medical Tech Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k234060/ 2024-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k234060-kidneyvault-portable-renal-perfusion-fda-510k.jpg K234060 - KIDNEYvault Portable Renal Perfusion System K234060 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Paragonix Technologies. Cleared Oct 2024. https://www.510kdatabase.net/k240289/ 2024-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k240289-full-hd-endoscopic-image-processor-fda-510k.jpg K240289 - Full HD Endoscopic Image Processor (HDVS-S200A, HDVS-S200B, HDVS-S200C, HDVS-S200D) K240289 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Scivita Medical Technology Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k240865/ 2024-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k240865-ids-isys-free-testosterone-fda-510k.jpg K240865 - IDS-iSYS Free Testosterone K240865 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Immunodiagnostic Systems Limited. Cleared Oct 2024. https://www.510kdatabase.net/k241324/ 2024-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k241324-lifescale-gram-negative-kit-lsgn-with-fda-510k.jpg K241324 - LifeScale Gram Negative Kit (LSGN) with the LifeScale AST system K241324 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Affinity Biosensors, LLC. Cleared Oct 2024. https://www.510kdatabase.net/k241753/ 2024-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k241753-immediate-molar-implants-fda-510k.jpg K241753 - Immediate Molar Implants K241753 is a FDA 510(k) cleared dental medical device. Manufacturer: Biomet 3i, LLC. Cleared Oct 2024. https://www.510kdatabase.net/k241876/ 2024-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k241876-vitesse-50-fda-510k.jpg K241876 - Vitesse (5.0) K241876 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems. Cleared Oct 2024. https://www.510kdatabase.net/k241988/ 2024-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k241988-proseal-closed-system-bag-access-fda-510k.jpg K241988 - ProSeal™ Closed System Bag Access K241988 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Epic Medical Pte. , Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k242073/ 2024-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k242073-steriject-ophthalmic-needle-fda-510k.jpg K242073 - STERiJECT Ophthalmic Needle K242073 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Tsk Laboratory International Japan KK. Cleared Oct 2024. https://www.510kdatabase.net/k242183/ 2024-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k242183-fractional-co2-laser-therapy-system-fda-510k.jpg K242183 - Fractional CO2 Laser Therapy System (EXFU CO2) K242183 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Weifang Mingliang Electronics Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k242513/ 2024-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k242513-flonavi-endoscopic-fluorescence-fda-510k.jpg K242513 - FloNavi Endoscopic Fluorescence Imaging System (OPTO-CAM214K, OPTO-CHD214KE, OPTOCHD214KH, OPTO-LED214K) K242513 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Guangdong Optomedic Technologies, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k242589/ 2024-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k242589-scarlet-al-t-fda-510k.jpg K242589 - Scarlet® AL-T K242589 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spineart SA. Cleared Oct 2024. https://www.510kdatabase.net/k242829/ 2024-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k242829-bluex-lumbar-expandable-cage-system-fda-510k.jpg K242829 - BluEX Lumbar Expandable Cage System K242829 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: L & K Biomed Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k242847/ 2024-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k242847-exsys-dexi-exsys-dexi-d401s-frm-fda-510k.jpg K242847 - EXSYS DEXi (EXSYS DEXi-D401S-FRM) K242847 is a FDA 510(k) cleared radiology medical device. Manufacturer: DRTECH Corporation. Cleared Oct 2024. https://www.510kdatabase.net/k242995/ 2024-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k242995-oic-small-mini-fragment-plate-system-fda-510k.jpg K242995 - OIC Small / Mini Fragment Plate System K242995 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: The Orthopaedic Implant Company. Cleared Oct 2024. https://www.510kdatabase.net/k243007/ 2024-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k243007-cd-horizon-spinal-system-fda-510k.jpg K243007 - CD Horizon™ Spinal System K243007 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k243012/ 2024-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k243012-mim-symphony-hdr-fusion-fda-510k.jpg K243012 - MIM – Symphony HDR Fusion K243012 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mim Software, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k243057/ 2024-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k243057-truefit-bolus-fda-510k.jpg K243057 - TrueFit Bolus K243057 is a FDA 510(k) cleared radiology medical device. Manufacturer: Adaptiiv Medical Technologies, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k240506/ 2024-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k240506-karl-storz-holders-fda-510k.jpg K240506 - KARL STORZ Holders K240506 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k241398/ 2024-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k241398-sdjmastervision-fluoroxyfocon-a-rigid-fda-510k.jpg K241398 - SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses K241398 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Tianjin Mastervision Technology Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k241478/ 2024-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k241478-tri-wedge-pta-scoring-balloon-fda-510k.jpg K241478 - Tri-Wedge PTA Scoring Balloon Dilatation Catheter K241478 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Brosmed Medical Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k241532/ 2024-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k241532-flexible-video-choledo-cysto-fda-510k.jpg K241532 - Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100) K241532 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Shanghai SeeGen Photoelectric Technology Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k241572/ 2024-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k241572-artis-icono-ve40a-floor-fda-510k.jpg K241572 - ARTIS icono (VE40A) (floor) K241572 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k241758/ 2024-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k241758-reprocessed-rd-set-adt-pulse-oximeter-fda-510k.jpg K241758 - Reprocessed RD SET Adt Pulse Oximeter Sensor (4000) K241758 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Stryker Sustainability Solutions. Cleared Oct 2024. https://www.510kdatabase.net/k242099/ 2024-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k242099-sol-m-slip-tip-syringe-without-needle-fda-510k.jpg K242099 - Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip Syringe without Needle K242099 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sol-Millennium Medical, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k242193/ 2024-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k242193-arm-type-blood-pressure-monitor-bpm82-fda-510k.jpg K242193 - Arm Type Blood Pressure Monitor (BPM82) K242193 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Avita Corporation. Cleared Oct 2024. https://www.510kdatabase.net/k242250/ 2024-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k242250-purastat-fda-510k.jpg K242250 - PuraStat K242250 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3-D Matrix Europe SAS. Cleared Oct 2024. https://www.510kdatabase.net/k243209/ 2024-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k243209-nordicmediva-fda-510k.jpg K243209 - nordicMEDiVA K243209 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nordicneurolab AS. Cleared Oct 2024. https://www.510kdatabase.net/k222740/ 2024-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k222740-venus-ag-120-160-200-2x2-inch-venus-ag-fda-510k.jpg K222740 - Venus Ag 120, 160, 200 2x2 inch, Venus Ag 120, 160, 200 4x4 inch, Venus Ag 120, 160, 200 4x5 inch, Venus Ag 120, 160, 200 6x6 inch,Venus Ag 120, 160, 200 1x18 inch K222740 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Speciality Fibres and Materials, Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k240029/ 2024-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k240029-zio-at-device-a100a1001-fda-510k.jpg K240029 - Zio AT® device (A100A1001) K240029 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: iRhythm Technologies, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k240783/ 2024-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k240783-anthology-hip-stems-fda-510k.jpg K240783 - Anthology Hip Stems K240783 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k241170/ 2024-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k241170-dynamic-tibase-fda-510k.jpg K241170 - Dynamic TiBase K241170 is a FDA 510(k) cleared dental medical device. Manufacturer: Talladium Espa?a, SL. Cleared Oct 2024. https://www.510kdatabase.net/k242058/ 2024-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k242058-digital-prism-correction-feature-dpcf-fda-510k.jpg K242058 - Digital Prism Correction Feature (DPCF) K242058 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Apple, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k242157/ 2024-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k242157-anovo-surgical-system-model-6ne-fda-510k.jpg K242157 - Anovo Surgical System (Model 6Ne) K242157 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Momentis Surgical , Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k242266/ 2024-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k242266-photonblade-3-fda-510k.jpg K242266 - PhotonBlade 3 K242266 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker Instruments. Cleared Oct 2024. https://www.510kdatabase.net/k242554/ 2024-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k242554-arthrex-val-and-val-kreulock-fda-510k.jpg K242554 - Arthrex VAL and VAL KreuLock™ Compression Screw System K242554 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k222944/ 2024-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k222944-safepath-sulturing-system-silk-suture-fda-510k.jpg K222944 - SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Suture (Nylon) SafePath Sulturing System- Polypropylene Suture K222944 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Safepath Medical, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k232994/ 2024-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k232994-vittra-aps-unique-flow-fda-510k.jpg K232994 - Vittra APS Unique Flow K232994 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentscare Ltda. Cleared Oct 2024. https://www.510kdatabase.net/k233054/ 2024-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k233054-well-life-pain-relief-menstrual-plus-fda-510k.jpg K233054 - Well-Life Pain Relief (Menstrual Plus) Electrical Stimulator K233054 is a FDA 510(k) cleared neurology medical device. Manufacturer: Well-Life Healthcare Limited. Cleared Oct 2024. https://www.510kdatabase.net/k233378/ 2024-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k233378-abccolla-collagen-adm-scaffold-fda-510k.jpg K233378 - ABCcolla® Collagen ADM Scaffold K233378 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Acro Biomedical Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k240226/ 2024-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k240226-pixie-skin-tag-fda-510k.jpg K240226 - Pixie Skin Tag K240226 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Oystershell NV. Cleared Oct 2024. https://www.510kdatabase.net/k240725/ 2024-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k240725-prexolid-cadcam-abutments-fda-510k.jpg K240725 - PreXolid CAD/CAM abutments K240725 is a FDA 510(k) cleared dental medical device. Manufacturer: Eclectic Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k240844/ 2024-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k240844-spectral-ct-7500-rt-fda-510k.jpg K240844 - Spectral CT 7500 RT K240844 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Technologies , Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k240916/ 2024-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k240916-surgical-face-mask-tie-on-ear-loops-fda-510k.jpg K240916 - Surgical Face Mask (Tie on/ Ear loops) K240916 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Xiantao Daoqi Plastic Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k241131/ 2024-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k241131-edelweiss-cadcam-t-block-fda-510k.jpg K241131 - edelweiss CAD/CAM T-BLOCK K241131 is a FDA 510(k) cleared dental medical device. Manufacturer: Edelweiss Dentistry Products GmbH. Cleared Oct 2024. https://www.510kdatabase.net/k241490/ 2024-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k241490-contour-mvision-ai-segmentation-fda-510k.jpg K241490 - Contour+ (MVision AI Segmentation) K241490 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mvision AI OY. Cleared Oct 2024. https://www.510kdatabase.net/k241830/ 2024-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k241830-mojo-full-face-vented-mask-fda-510k.jpg K241830 - Mojo Full Face Vented Mask K241830 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sleepnet Corporation. Cleared Oct 2024. https://www.510kdatabase.net/k241959/ 2024-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k241959-3m-attest-super-rapid-steam-clear-fda-510k.jpg K241959 - 3M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD) K241959 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Oct 2024. https://www.510kdatabase.net/k242132/ 2024-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k242132-freddo-fda-510k.jpg K242132 - FREDDO K242132 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Fabinject Lndustria E Comercio Lmportacao E Exportacao Ltda. Cleared Oct 2024. https://www.510kdatabase.net/k242372/ 2024-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k242372-mg-osteorevive-mg-osteocrete-fda-510k.jpg K242372 - Mg OSTEOREVIVE™, Mg OSTEOCRETE™ K242372 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Bone Solutions, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k242435/ 2024-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k242435-dental-barrier-and-sleeves-fda-510k.jpg K242435 - Dental Barrier and Sleeves K242435 is a FDA 510(k) cleared dental medical device. Manufacturer: Wellmed Dental Medical Supply Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k242473/ 2024-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k242473-altis-single-incision-sling-system-fda-510k.jpg K242473 - Altis Single Incision Sling System (519650) K242473 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Coloplast Corp.. Cleared Oct 2024. https://www.510kdatabase.net/k242813/ 2024-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k242813-materialise-shoulder-system-fda-510k.jpg K242813 - Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner K242813 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Materialise NV. Cleared Oct 2024. https://www.510kdatabase.net/k242828/ 2024-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k242828-corplex-p-theracor-p-allacor-p-fda-510k.jpg K242828 - Corplex P/ Theracor P/ Allacor P K242828 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stimlabs, LLC. Cleared Oct 2024. https://www.510kdatabase.net/k242837/ 2024-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k242837-briefcase-triage-fda-510k.jpg K242837 - BriefCase-Triage K242837 is a FDA 510(k) cleared radiology medical device. Manufacturer: Aidoc Medical , Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k242864/ 2024-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k242864-rosa-knee-system-fda-510k.jpg K242864 - ROSA® Knee System K242864 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthosoft Inc. (d/b/a) Zimmer CAS. Cleared Oct 2024. https://www.510kdatabase.net/k242868/ 2024-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k242868-kinos-total-ankle-system-fda-510k.jpg K242868 - Kinos Total Ankle System K242868 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Restor3d. Cleared Oct 2024. https://www.510kdatabase.net/k242879/ 2024-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k242879-ds-knee-coil-8ch-15t-fda-510k.jpg K242879 - dS Knee Coil 8ch 1.5T K242879 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Oct 2024. https://www.510kdatabase.net/k243033/ 2024-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k243033-ds-wrist-coil-8ch-15t-fda-510k.jpg K243033 - dS Wrist coil 8ch 1.5T K243033 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Oct 2024. https://www.510kdatabase.net/k243245/ 2024-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k243245-iceseed-15-cx-straight-needle-fda-510k.jpg K243245 - IceSeed 1.5 CX Straight Needle (H7493968333170) K243245 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Boston Scientific Corp. Cleared Oct 2024. https://www.510kdatabase.net/k211943/ 2024-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k211943-microlyte-aglidocaine-fda-510k.jpg K211943 - Microlyte Ag/Lidocaine K211943 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Imbed Biosciences. Cleared Oct 2024. https://www.510kdatabase.net/k240160/ 2024-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k240160-egps-navigated-instruments-fda-510k.jpg K240160 - EGPS Navigated Instruments K240160 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Astura Medical. Cleared Oct 2024. https://www.510kdatabase.net/k240218/ 2024-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k240218-electric-breast-pump-f5055-fda-510k.jpg K240218 - Electric Breast Pump (F5055) K240218 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Fimilla (Shanghai) Maternity & Baby Articles Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k240321/ 2024-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k240321-mp-pin-flat-without-thread-fda-510k.jpg K240321 - MP Pin flat without thread (36BMP000020/MP20) K240321 is a FDA 510(k) cleared dental medical device. Manufacturer: Hager& Meisinger GmbH. Cleared Oct 2024. https://www.510kdatabase.net/k240408/ 2024-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k240408-remi-ai-rapid-detection-module-remi-ai-fda-510k.jpg K240408 - REMI-AI Rapid Detection Module (REMI-AI RDM) K240408 is a FDA 510(k) cleared neurology medical device. Manufacturer: Epitel, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k240711/ 2024-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k240711-zipline-access-catheter-fda-510k.jpg K240711 - Zipline Access Catheter K240711 is a FDA 510(k) cleared neurology medical device. Manufacturer: Perfuze, Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k241242/ 2024-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k241242-signa-magnus-fda-510k.jpg K241242 - SIGNA MAGNUS K241242 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems, LLC. Cleared Oct 2024. https://www.510kdatabase.net/k241267/ 2024-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k241267-hidroxa-se30-fda-510k.jpg K241267 - Hidroxa SE30 K241267 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Hidroxa Medical AB. Cleared Oct 2024. https://www.510kdatabase.net/k241337/ 2024-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k241337-electrically-powered-wheelchair-hp202-fda-510k.jpg K241337 - Electrically powered wheelchair (HP202) K241337 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Kunshan Hi-Fortune Health Products Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k242197/ 2024-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k242197-ipl-hair-removal-device-dh4-dh5-dh5-fda-510k.jpg K242197 - IPL Hair Removal Device (DH4, DH5, DH5 Plus, DH5 Max) K242197 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Huaruibo Electric Appliances Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k242809/ 2024-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k242809-ascent-cardiorespiratory-diagnostic-fda-510k.jpg K242809 - Ascent Cardiorespiratory Diagnostic Software K242809 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Medical Graphics Corporation. Cleared Oct 2024. https://www.510kdatabase.net/k242899/ 2024-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k242899-nova-minimally-invasive-system-fda-510k.jpg K242899 - NOVA Minimally Invasive System K242899 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Baui Biotech Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k240114/ 2024-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k240114-ultraezair-uea1a-fda-510k.jpg K240114 - UltraEzAir® (UEA1A) K240114 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Dualams, Inc., Dba Airkor. Cleared Oct 2024. https://www.510kdatabase.net/k240364/ 2024-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k240364-relieev-uterine-manipulator-injector-fda-510k.jpg K240364 - RELIEEV Uterine Manipulator Injector (CUMI 5.0) K240364 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Li Medical Corporation , Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k240468/ 2024-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k240468-alkaline-phosphatase-fda-510k.jpg K240468 - Alkaline Phosphatase K240468 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories Diagnostics Division. Cleared Oct 2024. https://www.510kdatabase.net/k240596/ 2024-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k240596-cerebral-autoregulation-index-cai-fda-510k.jpg K240596 - Cerebral Autoregulation Index (CAI) Algorithm K240596 is a FDA 510(k) cleared neurology medical device. Manufacturer: Edwards Lifesciences. Cleared Oct 2024. https://www.510kdatabase.net/k240849/ 2024-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k240849-ambu-ascope-5-cysto-hd-standard-fda-510k.jpg K240849 - Ambu® aScope™ 5 Cysto HD (Standard Deflection) K240849 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ambu A/S. Cleared Oct 2024. https://www.510kdatabase.net/k241221/ 2024-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k241221-cereglide-42-intermediate-catheter-fda-510k.jpg K241221 - CEREGLIDE 42 Intermediate Catheter K241221 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cerenovus, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k241244/ 2024-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k241244-cereglide-42-intermediate-catheter-fda-510k.jpg K241244 - CEREGLIDE 42 Intermediate Catheter K241244 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cerenovus, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k241272/ 2024-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k241272-stryker-steri-shield-8-surgical-hoods-fda-510k.jpg K241272 - Stryker Steri-Shield 8 Surgical Hoods and Togas K241272 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Stryker Instruments. Cleared Oct 2024. https://www.510kdatabase.net/k241481/ 2024-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k241481-xvision-spine-system-fda-510k.jpg K241481 - xvision Spine System K241481 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Augmedics, Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k241613/ 2024-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k241613-elecrtronic-blood-pressure-monitor-bp-fda-510k.jpg K241613 - Elecrtronic Blood Pressure Monitor (BP-201, BP-202, BP-203, BP-204, BP-205, BP-206) K241613 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Hbcare Technology Co.,Ltd. Cleared Oct 2024. https://www.510kdatabase.net/k241632/ 2024-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k241632-electrically-powered-wheelchair-fda-510k.jpg K241632 - Electrically powered wheelchair K241632 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Kunshan Hi-Fortune Health Products Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k242556/ 2024-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k242556-jlk-ctp-fda-510k.jpg K242556 - JLK-CTP K242556 is a FDA 510(k) cleared radiology medical device. Manufacturer: JLK, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k242784/ 2024-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k242784-vy-spine-vylam-laminoplasty-system-fda-510k.jpg K242784 - Vy Spine™ VyLam™ Laminoplasty System K242784 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Vy Spine, LLC. Cleared Oct 2024. https://www.510kdatabase.net/k242794/ 2024-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k242794-oncozene-microspheres-fda-510k.jpg K242794 - ONCOZENE Microspheres K242794 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k242839/ 2024-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k242839-safe-secure-sterilization-pouches-and-fda-510k.jpg K242839 - Safe Secure Sterilization Pouches and Rolls K242839 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/den230087/ 2024-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/den230087-amstent-tracheobronchial-covered-stent-fda-510k.jpg DEN230087 - AMStent® Tracheobronchial Covered Stent System DEN230087 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Peytant Solutions, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k231997/ 2024-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k231997-sirona-100-therapy-laser-system-oems-fda-510k.jpg K231997 - SIRONA 100 Therapy Laser System (OEM's Model EVANLAS) K231997 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cure Point Therapeutics, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k240192/ 2024-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k240192-single-use-extraction-baskets-fda-510k.jpg K240192 - Single-use Extraction Baskets K240192 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Scivita Medical Technology Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k240385/ 2024-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k240385-vint-fda-510k.jpg K240385 - VINT K240385 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mediimg Corporation. Cleared Oct 2024. https://www.510kdatabase.net/k241673/ 2024-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k241673-denture-base-resin-pn-denture-red-white-fda-510k.jpg K241673 - Denture Base Resin (PN-Denture (Red, White)) K241673 is a FDA 510(k) cleared dental medical device. Manufacturer: Shenzhen Piocreat 3D Technology Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k241894/ 2024-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k241894-artix-mt-fda-510k.jpg K241894 - Artix™ MT K241894 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inari Medical, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k242097/ 2024-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k242097-denmat-bulk-fill-composite-fda-510k.jpg K242097 - DenMat Bulk Fill Composite K242097 is a FDA 510(k) cleared dental medical device. Manufacturer: Den-Mat Holdings, LLC. Cleared Oct 2024. https://www.510kdatabase.net/k242536/ 2024-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k242536-tautona-pneumoperitoneum-assist-device-fda-510k.jpg K242536 - TauTona Pneumoperitoneum Assist Device (TPAD) K242536 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Tautona Group. Cleared Oct 2024. https://www.510kdatabase.net/k242781/ 2024-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k242781-cvi42-software-application-fda-510k.jpg K242781 - cvi42 Software Application K242781 is a FDA 510(k) cleared radiology medical device. Manufacturer: Circle Cardiovascular Imaging, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k242795/ 2024-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k242795-getinge-assured-mi-steam-migrating-fda-510k.jpg K242795 - Getinge Assured MI Steam Migrating Integrator K242795 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Steritec Products Mfg. (A Getinge Group Company). Cleared Oct 2024. https://www.510kdatabase.net/k242812/ 2024-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k242812-nitrile-examination-gloves-tested-for-fda-510k.jpg K242812 - NITRILE EXAMINATION GLOVES (Tested For Use With Chemotherapy Drugs) K242812 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Nb Medical Company Limited. Cleared Oct 2024. https://www.510kdatabase.net/k232565/ 2024-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k232565-urisponge-fda-510k.jpg K232565 - UriSponge™ K232565 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Copan Italia Spa. Cleared Oct 2024. https://www.510kdatabase.net/k232779/ 2024-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k232779-quex-ed-fda-510k.jpg K232779 - QUEX ED K232779 is a FDA 510(k) cleared neurology medical device. Manufacturer: Qx World, Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k233265/ 2024-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k233265-monotime-and-optime-r-fda-510k.jpg K233265 - Monotime and Optime R K233265 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Peters Surgical. Cleared Oct 2024. https://www.510kdatabase.net/k234110/ 2024-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k234110-belun-ring-blr-200-blr-200-fda-510k.jpg K234110 - Belun Ring BLR-200 (BLR-200) K234110 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Belun Technology Company Limited. Cleared Oct 2024. https://www.510kdatabase.net/k240143/ 2024-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k240143-jdzygoma-dental-implants-fda-510k.jpg K240143 - JDZygoma dental implants K240143 is a FDA 510(k) cleared dental medical device. Manufacturer: Jdentalcare Srl. Cleared Oct 2024. https://www.510kdatabase.net/k240242/ 2024-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k240242-hcg-home-use-pregnancy-test-strip-fda-510k.jpg K240242 - HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold) K240242 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Anhui Deepblue Medical Technology Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k240472/ 2024-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k240472-pbm-hair-therapy-cap-fda-510k.jpg K240472 - PBM Hair Therapy Cap K240472 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Dongguan Tutamen Metalwork Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k240499/ 2024-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k240499-artaira-arterial-compression-device-fda-510k.jpg K240499 - ARTAIRA Arterial Compression Device (AACD01) K240499 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Airos Medical, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k240501/ 2024-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k240501-spark-clear-aligner-system-fda-510k.jpg K240501 - Spark™ Clear Aligner System K240501 is a FDA 510(k) cleared dental medical device. Manufacturer: Ormco Corporation. Cleared Oct 2024. https://www.510kdatabase.net/k240797/ 2024-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k240797-pph-saliva-collection-kit-fda-510k.jpg K240797 - PPH Saliva Collection Kit K240797 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Permantis Public Health. Cleared Oct 2024. https://www.510kdatabase.net/k240826/ 2024-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k240826-reprocessed-decanav-electrophysiology-fda-510k.jpg K240826 - Reprocessed DECANAV™ Electrophysiology Catheter K240826 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sterilmed, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k241153/ 2024-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k241153-progressive-orthodontics-app-fda-510k.jpg K241153 - Progressive Orthodontics App K241153 is a FDA 510(k) cleared dental medical device. Manufacturer: Progressive Aligners, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k241163/ 2024-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k241163-spectralis-with-flex-module-fda-510k.jpg K241163 - SPECTRALIS with Flex Module K241163 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Heidelberg Engineering GmbH. Cleared Oct 2024. https://www.510kdatabase.net/k241569/ 2024-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k241569-syngo-application-software-fda-510k.jpg K241569 - syngo Application Software K241569 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k241857/ 2024-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k241857-led-light-therapy-device-kfb290-kfb291-fda-510k.jpg K241857 - LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) K241857 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Dongguan Boyuan Intelligent Technology Co.,Ltd. Cleared Oct 2024. https://www.510kdatabase.net/k241971/ 2024-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k241971-hera-z20-r20-hera-z30-r30-diagnostic-fda-510k.jpg K241971 - HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System K241971 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Medison Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k242035/ 2024-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k242035-accure-laser-system-fda-510k.jpg K242035 - Accure Laser System K242035 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Accure Acne, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k242095/ 2024-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k242095-access-toxo-igm-ii-fda-510k.jpg K242095 - Access Toxo IgM II K242095 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k242133/ 2024-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k242133-intra-operative-positioning-system-fda-510k.jpg K242133 - Intra-Operative Positioning System (IOPS®) (Fiducial Tracking Pad) K242133 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Centerline Biomedical, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k242387/ 2024-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k242387-mobility-scooter-n3473-fda-510k.jpg K242387 - Mobility Scooter (N3473) K242387 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zhejiang Innuovo Rehabilitation Devices Co.,Ltd. Cleared Oct 2024. https://www.510kdatabase.net/k242742/ 2024-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k242742-defendo-single-use-valve-kit-aws-fda-510k.jpg K242742 - DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) K242742 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: STERIS Corporation. Cleared Oct 2024. https://www.510kdatabase.net/k242778/ 2024-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k242778-x-sensor-model-ios-a15if-hdi-15dgf-fda-510k.jpg K242778 - X Sensor (Model: IOS-A15IF, HDI-15DGF) K242778 is a FDA 510(k) cleared radiology medical device. Manufacturer: Qpix Solutions, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k242779/ 2024-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k242779-hood-dh-083st-fda-510k.jpg K242779 - Hood (DH-083ST) K242779 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fujifilm Corporation. Cleared Oct 2024. https://www.510kdatabase.net/k242833/ 2024-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k242833-legend-acetabular-shell-fda-510k.jpg K242833 - Legend® Acetabular Shell K242833 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ortho Development Corp.. Cleared Oct 2024. https://www.510kdatabase.net/den230078/ 2024-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/den230078-versius-surgical-system-fda-510k.jpg DEN230078 - Versius Surgical System DEN230078 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cmr Surgical Limited. Cleared Oct 2024. https://www.510kdatabase.net/k230325/ 2024-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k230325-greens-brand-posterior-non-cervical-fda-510k.jpg K230325 - GREENS BRAND Posterior, Non-cervical Pedicle Screw Spinal System K230325 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Greens Surgicals Pvt. , Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k233947/ 2024-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k233947-klimt-expandable-lumbar-interbody-fda-510k.jpg K233947 - KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage System K233947 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ctl Medical Corporation. Cleared Oct 2024. https://www.510kdatabase.net/k240262/ 2024-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k240262-bti-interna-30-dental-implant-system-fda-510k.jpg K240262 - BTI Interna 3.0 Dental Implant System UnicCa® K240262 is a FDA 510(k) cleared dental medical device. Manufacturer: B.T.I. Biotechnology Institute, Sl.. Cleared Oct 2024. https://www.510kdatabase.net/k240315/ 2024-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k240315-innovance-anti-xa-oppu05-fda-510k.jpg K240315 - INNOVANCE Anti-Xa (OPPU05) K240315 is a FDA 510(k) cleared hematology medical device. Manufacturer: Siemens Healthcare Diagnostics Products GmbH. Cleared Oct 2024. https://www.510kdatabase.net/k240786/ 2024-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k240786-autochamber-fda-510k.jpg K240786 - AutoChamber K240786 is a FDA 510(k) cleared radiology medical device. Manufacturer: HeartLung Corporation. Cleared Oct 2024. https://www.510kdatabase.net/k240848/ 2024-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k240848-ambu-ascope-5-cysto-hd-standard-fda-510k.jpg K240848 - Ambu® aScope™ 5 Cysto HD (Standard Deflection) K240848 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ambu A/S. Cleared Oct 2024. https://www.510kdatabase.net/k240992/ 2024-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k240992-emvfit-mvf-10m-fda-510k.jpg K240992 - eMVFit (MVF-10M) K240992 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Weero Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k241092/ 2024-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k241092-youlaser-prime-fda-510k.jpg K241092 - Youlaser PRIME K241092 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Quanta System Spa. Cleared Oct 2024. https://www.510kdatabase.net/k241430/ 2024-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k241430-echomeasure-fda-510k.jpg K241430 - EchoMeasure K241430 is a FDA 510(k) cleared radiology medical device. Manufacturer: Icardio.Ai. Cleared Oct 2024. https://www.510kdatabase.net/k241491/ 2024-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k241491-blueprint-patient-specific-fda-510k.jpg K241491 - Blueprint Patient-Specific Instrumentation K241491 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Corporation (Tornier, S.A.S.). Cleared Oct 2024. https://www.510kdatabase.net/k241735/ 2024-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k241735-proseal-in-line-pump-set-423850-fda-510k.jpg K241735 - ProSeal™ In Line Pump Set (423850) K241735 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Epic Medical Pte. , Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k241951/ 2024-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k241951-lasya-trinity-fda-510k.jpg K241951 - Lasya-Trinity K241951 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: BLUECORE COMPANY Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k242389/ 2024-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k242389-eyegility-inserter-for-preloaded-fda-510k.jpg K242389 - EyeGility™ Inserter for Preloaded enVista IOLs K242389 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Bausch & Lomb, Incorporated. Cleared Oct 2024. https://www.510kdatabase.net/k242400/ 2024-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k242400-dental-porcelain-powder-fda-510k.jpg K242400 - Dental porcelain powder K242400 is a FDA 510(k) cleared dental medical device. Manufacturer: Yilink (Tianjin) Biotechnology Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k242515/ 2024-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k242515-udr-380i-pro-fda-510k.jpg K242515 - uDR 380i Pro K242515 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k231948/ 2024-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k231948-mediyag-fda-510k.jpg K231948 - MEDIYAG K231948 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medicreations, LLC. Cleared Oct 2024. https://www.510kdatabase.net/k240095/ 2024-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k240095-careus-contact-lens-case-model-1-model-fda-510k.jpg K240095 - CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6) K240095 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Shanghai Care US Medical Product Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k240181/ 2024-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k240181-clavicle-and-scapula-system-fda-510k.jpg K240181 - Clavicle and Scapula System K240181 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Auxein Medical Pvt., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k240991/ 2024-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k240991-emvfit-mvf-10m-fda-510k.jpg K240991 - eMVFit (MVF-10M) K240991 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Weero Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k241355/ 2024-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k241355-ser-pen-carain-microsystem-mp1209sp-fda-510k.jpg K241355 - SER Pen Carain MicroSystem (MP1209SP) K241355 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Su-Ko Technologies, LLC. Cleared Oct 2024. https://www.510kdatabase.net/k241477/ 2024-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k241477-aprevo-anterior-lumbar-interbody-fda-510k.jpg K241477 - aprevo® anterior lumbar interbody fusion device with interfixation K241477 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Carlsmed, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k241485/ 2024-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k241485-truabutment-ds-fda-510k.jpg K241485 - TruAbutment DS K241485 is a FDA 510(k) cleared dental medical device. Manufacturer: Truabutment, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k241837/ 2024-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k241837-limbus-contour-fda-510k.jpg K241837 - Limbus Contour K241837 is a FDA 510(k) cleared radiology medical device. Manufacturer: Limbus Ai, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k242021/ 2024-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k242021-the-sensititre-20-24-hour-haemophilus-fda-510k.jpg K242021 - The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Meropenem in the dilution range of 0.015 - 32 ug/ml. K242021 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Thermo Fisher Scientific. Cleared Oct 2024. https://www.510kdatabase.net/k242029/ 2024-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k242029-trap-easy-fda-510k.jpg K242029 - TRAP EASY K242029 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: H.S Hospital Service S.P.A. Cleared Oct 2024. https://www.510kdatabase.net/k242691/ 2024-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k242691-osteocentric-technologies-cannulated-fda-510k.jpg K242691 - OsteoCentric Technologies Cannulated Fasteners and Nuts K242691 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OsteoCentric Technologies. Cleared Oct 2024. https://www.510kdatabase.net/k240167/ 2024-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k240167-single-use-ureteral-access-sheath-fda-510k.jpg K240167 - Single-use Ureteral Access Sheath K240167 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hunan Vathin Medical Instrument Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k240379/ 2024-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k240379-trojan-sis-synthetic-latex-condom-with-fda-510k.jpg K240379 - TROJAN SIS Synthetic Latex Condom with Silicone Lubricant K240379 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Church & Dwight Co., Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k240563/ 2024-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k240563-power-wheelchair-jjw-6001-fda-510k.jpg K240563 - Power Wheelchair (JJW-6001) K240563 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: ZheJiang J&J Mobility Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k240640/ 2024-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k240640-sejoy-blood-glucose-monitoring-system-fda-510k.jpg K240640 - Sejoy Blood Glucose Monitoring System K240640 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sejoy Biomedical Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k241446/ 2024-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k241446-air-compression-massager-acm-a1-acm-a2-fda-510k.jpg K241446 - Air Compression Massager (ACM-A1, ACM-A2, ACM-A3, ACM-A4) K241446 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Sichuan Qianii-Beoka Medical Technoiogy Lnc.. Cleared Oct 2024. https://www.510kdatabase.net/k241756/ 2024-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k241756-nerivio-fda-510k.jpg K241756 - Nerivio K241756 is a FDA 510(k) cleared neurology medical device. Manufacturer: Theranica Bio-Electronics, Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k242014/ 2024-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k242014-jet-flow-bulk-fda-510k.jpg K242014 - Jet Flow Bulk K242014 is a FDA 510(k) cleared dental medical device. Manufacturer: Meta Biomed Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k242267/ 2024-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k242267-gemini-medical-cage-system-fda-510k.jpg K242267 - Gemini Medical Cage System K242267 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: ZheJiang Decans Medical Devices Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k242391/ 2024-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k242391-lucens-41-senofilcon-c-silicone-fda-510k.jpg K242391 - Lucens 41 (senofilcon C) Silicone Hydrogel Soft (Hydrophilic) Contact Lens K242391 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Lucens Technology Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k242826/ 2024-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k242826-prolift-wedge-expandable-spacer-system-fda-510k.jpg K242826 - ProLift Wedge Expandable Spacer System K242826 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/den230076/ 2024-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/den230076-omron-blood-pressure-monitor-with-fda-510k.jpg DEN230076 - Omron Blood Pressure Monitor with Atrial Fibrillation (AFib) Detection Feature (BP7460 (HEM-7371T1-AZ)) DEN230076 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Omron Healthcare, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k240485/ 2024-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k240485-luofucon-extra-silver-gelling-fiber-fda-510k.jpg K240485 - LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use) K240485 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Huizhou Foryou Medical Devices Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k240843/ 2024-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k240843-genesis-ms-p02-gen-fda-510k.jpg K240843 - GENESIS (MS-P02-GEN) K240843 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Climbing Steps, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k240980/ 2024-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k240980-epiq-series-diagnostic-ultrasound-system-fda-510k.jpg K240980 - EPIQ Series Diagnostic Ultrasound System K240980 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Ultrasound, LLC. Cleared Oct 2024. https://www.510kdatabase.net/k241029/ 2024-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k241029-spineus-system-fda-510k.jpg K241029 - SpineUs™ System K241029 is a FDA 510(k) cleared radiology medical device. Manufacturer: Verdure Imaging. Cleared Oct 2024. https://www.510kdatabase.net/k242084/ 2024-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k242084-emphasys-acetabular-shell-with-fda-510k.jpg K242084 - EMPHASYS Acetabular Shell with RapiTite HA K242084 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Ireland UC. Cleared Oct 2024. https://www.510kdatabase.net/k242152/ 2024-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k242152-smartez-elastomeric-infusion-pump-fda-510k.jpg K242152 - SMARTeZ™ Elastomeric Infusion Pump (498111, 498121, 498131, 498141) K242152 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Epic Medical Pte. , Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k242208/ 2024-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k242208-primed-sterilization-wrap-p100-p200-fda-510k.jpg K242208 - PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) K242208 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Primed Medical Products, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k242357/ 2024-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k242357-water-container-maj-901-fda-510k.jpg K242357 - Water Container (MAJ-901) K242357 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Medical Systems Corporation. Cleared Oct 2024. https://www.510kdatabase.net/k242375/ 2024-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k242375-or3o-dual-mobility-system-fda-510k.jpg K242375 - OR3O Dual Mobility System K242375 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k242457/ 2024-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k242457-earp-interbody-system-fda-510k.jpg K242457 - EARP Interbody System K242457 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Retropsoas Technologies, LLC. Cleared Oct 2024. https://www.510kdatabase.net/k242693/ 2024-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k242693-deka-infusion-system-deka-fda-510k.jpg K242693 - DEKA Infusion System, DEKA Administration Set K242693 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Deka Research and Development Corporation. Cleared Oct 2024. https://www.510kdatabase.net/k242746/ 2024-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k242746-overtureti-knee-resurfacing-systemtm-fda-510k.jpg K242746 - OvertureTi Knee Resurfacing SystemTM K242746 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Overture Orthopaedics. Cleared Oct 2024. https://www.510kdatabase.net/den240029/ 2024-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/den240029-healgen-rapid-check-covid-19flu-ab-fda-510k.jpg DEN240029 - Healgen Rapid Check COVID-19/Flu A&B Antigen Test DEN240029 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Healgen. Cleared Oct 2024. https://www.510kdatabase.net/k242445/ 2024-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k242445-pangea-platform-fda-510k.jpg K242445 - Pangea Platform K242445 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker GmbH. Cleared Oct 2024. https://www.510kdatabase.net/k240074/ 2024-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k240074-single-use-flexible-ureteroscope-ur-d1-fda-510k.jpg K240074 - Single use flexible ureteroscope (UR-D1) K240074 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Shenzhen Besdata Technology Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k240376/ 2024-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k240376-electroporation-system-n3000-fda-510k.jpg K240376 - Electroporation System (N3000) K240376 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k240553/ 2024-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k240553-lvivo-software-application-fda-510k.jpg K240553 - LVivo Software Application K240553 is a FDA 510(k) cleared radiology medical device. Manufacturer: Dia Imaging Analysis, Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k240675/ 2024-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k240675-endoscopic-injection-needles-fda-510k.jpg K240675 - Endoscopic Injection Needles K240675 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Promisemed Hangzhou Meditech Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k241052/ 2024-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k241052-bladeless-trocar-fda-510k.jpg K241052 - Bladeless Trocar K241052 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Advamedix, GmbH. Cleared Oct 2024. https://www.510kdatabase.net/k241245/ 2024-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k241245-echosolv-as-fda-510k.jpg K241245 - EchoSolv AS K241245 is a FDA 510(k) cleared radiology medical device. Manufacturer: Echo IQ, Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k241298/ 2024-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k241298-quadsense-fda-510k.jpg K241298 - QUADSENSE K241298 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Eventum Orthopaedics, Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k241434/ 2024-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k241434-video-ureteroscope-system-fda-510k.jpg K241434 - Video Ureteroscope System K241434 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hunan Vathin Medical Instrument Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k241746/ 2024-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k241746-umed-reprocessed-aircast-venaflow-foot-fda-510k.jpg K241746 - UMED REPROCESSED AIRCAST VENAFLOW FOOT CUFF K241746 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: United Medical Resources, LLC. Cleared Oct 2024. https://www.510kdatabase.net/k241796/ 2024-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k241796-trocare-trokit-laparoscope-lens-wiper-fda-510k.jpg K241796 - TroCare TroKit Laparoscope Lens Wiper (CP000626) K241796 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: TroCare, LLC. Cleared Oct 2024. https://www.510kdatabase.net/k241854/ 2024-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k241854-power-wheelchair-fda-510k.jpg K241854 - Power Wheelchair K241854 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Anhui Jbh Medical Apparatus Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k241869/ 2024-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k241869-biosieve-fentanyl-fia-home-test-kit-fda-510k.jpg K241869 - BioSieve™ Fentanyl FIA Home Test Kit K241869 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Vivachek Biotech (Hangzhou) Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k242106/ 2024-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k242106-aust-steerable-sheath-fda-510k.jpg K242106 - AuST Steerable Sheath K242106 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: CenterPoint Systems, LLC. Cleared Oct 2024. https://www.510kdatabase.net/k242325/ 2024-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k242325-griptract-gi-endoscopic-tissue-fda-510k.jpg K242325 - GripTract-GI Endoscopic Tissue Manipulator Lower GI Models K242325 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Actuated Medical, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k242343/ 2024-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k242343-bps-wrist-fracture-system-fda-510k.jpg K242343 - BPS Wrist Fracture System K242343 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthonovis, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k242351/ 2024-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k242351-zeta-cranial-navigation-system-zns131-us-fda-510k.jpg K242351 - Zeta Cranial Navigation System (ZNS131-US) K242351 is a FDA 510(k) cleared neurology medical device. Manufacturer: Zeta Surgical, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k242364/ 2024-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k242364-identiti-ii-interbody-system-fda-510k.jpg K242364 - IdentiTi™ II Interbody System K242364 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k242652/ 2024-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k242652-lunit-insight-dbt-v11-fda-510k.jpg K242652 - Lunit INSIGHT DBT v1.1 K242652 is a FDA 510(k) cleared radiology medical device. Manufacturer: Lunit, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k242671/ 2024-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k242671-treace-medical-concepts-tmc-screw-fda-510k.jpg K242671 - Treace Medical Concepts (TMC) Screw Fixation System K242671 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Treace Medical Concepts, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k242679/ 2024-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k242679-disposable-powered-articulating-fda-510k.jpg K242679 - Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm series) K242679 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Fengh Medical Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k242721/ 2024-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k242721-upper-arm-electronic-blood-pressure-fda-510k.jpg K242721 - Upper Arm Electronic Blood Pressure Monitor (FC-BP103, FC-BP106, FC-BP113, FC-BP120, FC-BP121, FC-BP130, FC-BP131) K242721 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Finicare Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k233497/ 2024-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k233497-rest-assure-system-fda-510k.jpg K233497 - Rest Assure System K233497 is a FDA 510(k) cleared dental medical device. Manufacturer: Somnomed, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k240393/ 2024-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k240393-exactech-truliant-knee-system-fda-510k.jpg K240393 - Exactech® TRULIANT® Knee System K240393 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k240586/ 2024-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k240586-additive-manufacturing-zirconia-fda-510k.jpg K240586 - Additive Manufacturing Zirconia Customized Restoration K240586 is a FDA 510(k) cleared dental medical device. Manufacturer: Hangzhou Thales Medtech Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k240808/ 2024-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k240808-pulse-oximeter-ws20a-fda-510k.jpg K240808 - Pulse Oximeter (WS20A) K240808 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Hunan Accurate Bio-Medical Technology Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k241472/ 2024-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k241472-icona-hip-stem-fda-510k.jpg K241472 - Icona Hip Stem K241472 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corin U.S.A. Limited. Cleared Oct 2024. https://www.510kdatabase.net/k241977/ 2024-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k241977-injectable-root-canal-bioceramic-fda-510k.jpg K241977 - Injectable Root Canal Bioceramic Sealer (i-MTA SP) K241977 is a FDA 510(k) cleared dental medical device. Manufacturer: Longly Biotechnology (Wuhan) Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k242507/ 2024-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k242507-obsidio-conformable-embolic-fda-510k.jpg K242507 - OBSIDIO™ Conformable Embolic K242507 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific. Cleared Oct 2024. https://www.510kdatabase.net/k242616/ 2024-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k242616-lantern-hip-fda-510k.jpg K242616 - Lantern® Hip K242616 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthalign, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k242660/ 2024-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k242660-curlin-8000-ambulatory-infusion-system-fda-510k.jpg K242660 - Curlin 8000 Ambulatory Infusion System K242660 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zevex, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k240153/ 2024-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k240153-ceramic-etchant-hf-5-and-hf-9-fda-510k.jpg K240153 - Ceramic Etchant (HF-5 and HF-9) K240153 is a FDA 510(k) cleared dental medical device. Manufacturer: Liaoning Upcera Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k240529/ 2024-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k240529-8f-modified-sheath-system-fda-510k.jpg K240529 - 8F Modified Sheath System K240529 is a FDA 510(k) cleared neurology medical device. Manufacturer: Route 92 Medical, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k240889/ 2024-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k240889-artfx-lumbar-peek-cages-fda-510k.jpg K240889 - ARTFX Lumbar PEEK Cages K240889 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Artfx Medical. Cleared Oct 2024. https://www.510kdatabase.net/k241097/ 2024-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k241097-arthrex-virtual-implant-positioning-fda-510k.jpg K241097 - Arthrex Virtual Implant Positioning (VIP) System Software K241097 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k241487/ 2024-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k241487-interwedge-standalone-lateral-fda-510k.jpg K241487 - Interwedge® Standalone Lateral K241487 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Foundation Surgical Group, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k241561/ 2024-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k241561-mammoscreen-bd-fda-510k.jpg K241561 - MammoScreen BD K241561 is a FDA 510(k) cleared radiology medical device. Manufacturer: Therapixel. Cleared Oct 2024. https://www.510kdatabase.net/k241907/ 2024-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k241907-anovo-surgical-system-model-6n-fda-510k.jpg K241907 - Anovo Surgical System (model 6N) K241907 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Momentis Surgical , Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k241925/ 2024-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k241925-vitruvianscan-v10-fda-510k.jpg K241925 - VitruvianScan (v1.0) K241925 is a FDA 510(k) cleared radiology medical device. Manufacturer: Perspectum, Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k242005/ 2024-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k242005-versana-premier-fda-510k.jpg K242005 - Versana Premier K242005 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared Oct 2024. https://www.510kdatabase.net/k242302/ 2024-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k242302-rejuvaknee-collagen-meniscus-implant-fda-510k.jpg K242302 - RejuvaKnee™ Collagen Meniscus Implant K242302 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Collagen Matrix, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k242377/ 2024-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k242377-remedy-stemmed-knee-spacer-system-with-fda-510k.jpg K242377 - REMEDY Stemmed Knee Spacer System with All-Poly Tibial Component K242377 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteoremedies, LLC. Cleared Oct 2024. https://www.510kdatabase.net/k242613/ 2024-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k242613-nxtag-respiratory-pathogen-panel-fda-510k.jpg K242613 - NxTAG® Respiratory Pathogen Panel K242613 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Luminex Molecular Diagnostics, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k240331/ 2024-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k240331-electric-wheelchair-yhwl002-yhwl003-fda-510k.jpg K240331 - Electric wheelchair (YHWL002, YHWL003) K240331 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Yongkang Youha Electric Appliance Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k240917/ 2024-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k240917-esperance-3-aspiration-catheter-system-fda-510k.jpg K240917 - Esperance 3+ Aspiration Catheter System K240917 is a FDA 510(k) cleared neurology medical device. Manufacturer: Wallaby Medical. Cleared Oct 2024. https://www.510kdatabase.net/k240943/ 2024-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k240943-lungvision-fda-510k.jpg K240943 - LungVision K240943 is a FDA 510(k) cleared radiology medical device. Manufacturer: Bodyvision Medical , Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k241285/ 2024-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k241285-disposable-endoscope-valves-set-af-fda-510k.jpg K241285 - Disposable Endoscope Valves Set (AF series) K241285 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Alton (Shanghai) Medical Instruments Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k241331/ 2024-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k241331-muscleview-fda-510k.jpg K241331 - MuscleView K241331 is a FDA 510(k) cleared radiology medical device. Manufacturer: Springbok, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k241967/ 2024-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k241967-the-sensititre-20-24-hour-haemophilus-fda-510k.jpg K241967 - The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with ceftriaxone in the dilution range of 0.015 - 2 ug/ml. K241967 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Thermo Fisher Scientific. Cleared Oct 2024. https://www.510kdatabase.net/k242277/ 2024-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k242277-crown-ht-fda-510k.jpg K242277 - Crown HT K242277 is a FDA 510(k) cleared dental medical device. Manufacturer: Sprintray, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k242498/ 2024-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k242498-pocguide-multi-drug-test-panel-fda-510k.jpg K242498 - Pocguide Multi-Drug Test Panel, Pocguide Multi-Drug Test Panel OTC K242498 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Aicheck Biotech, Inc.. Cleared Oct 2024. https://www.510kdatabase.net/k242651/ 2024-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k242651-gm85-fda-510k.jpg K242651 - GM85 K242651 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Electronics Co., Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k242678/ 2024-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k242678-definium-pace-select-et-fda-510k.jpg K242678 - Definium Pace Select ET K242678 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Hualun Medical Systems Co. , Ltd.. Cleared Oct 2024. https://www.510kdatabase.net/k210933/ 2024-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k210933-ysi-2900c-biochemistry-analyzer-fda-510k.jpg K210933 - YSI 2900C Biochemistry Analyzer K210933 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Ysi, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k241151/ 2024-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k241151-luxen-5g-fda-510k.jpg K241151 - LUXEN 5G K241151 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentalmax Co., Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k241317/ 2024-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k241317-wondfo-2019-ncov-antigen-test-lateral-fda-510k.jpg K241317 - Wondfo 2019-nCoV Antigen Test (Lateral Flow Method) K241317 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k241657/ 2024-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k241657-msfx-mikron-spinal-fixation-system-fda-510k.jpg K241657 - MSFX MIKRON SPINAL FIXATION SYSTEM K241657 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Mikron Makina Sanayi VE Ticaret Ltd. Sti.. Cleared Sep 2024. https://www.510kdatabase.net/k241836/ 2024-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k241836-kem-medical-lead-free-chemical-fda-510k.jpg K241836 - Kem Medical Lead-free Chemical Indicators for Steam Sterilization K241836 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Kem Medical Products Corporation. Cleared Sep 2024. https://www.510kdatabase.net/k241952/ 2024-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k241952-aquabeam-robotic-system-ab2000-fda-510k.jpg K241952 - AQUABEAM Robotic System (AB2000) K241952 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Procept Biorobotics. Cleared Sep 2024. https://www.510kdatabase.net/k242154/ 2024-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k242154-numen-coil-embolization-system-fda-510k.jpg K242154 - Numen™ Coil Embolization System K242154 is a FDA 510(k) cleared neurology medical device. Manufacturer: MicroPort NeuroTech (Shanghai) Co., Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k242276/ 2024-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k242276-crossfast-integrated-microcatheter-fda-510k.jpg K242276 - CrossFAST™ Integrated Microcatheter Guide Extension System (CFM55) K242276 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vantis Vascular, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/den230011/ 2024-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/den230011-ocucool-fda-510k.jpg DEN230011 - OcuCool DEN230011 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Recensmedical, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k233446/ 2024-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k233446-amc-health-careconsole-fda-510k.jpg K233446 - AMC Health CareConsole K233446 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Amc Health. Cleared Sep 2024. https://www.510kdatabase.net/k240163/ 2024-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k240163-hudson-rci-comfort-flo-nasal-cannula-fda-510k.jpg K240163 - Hudson RCI® Comfort Flo Nasal Cannula K240163 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Medline Industries, LP. Cleared Sep 2024. https://www.510kdatabase.net/k240220/ 2024-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k240220-aulisa-temperature-module-tm0002-fda-510k.jpg K240220 - Aulisa Temperature Module (TM0002) K240220 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Taiwan Aulisa Medical Devices Technologies, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k240369/ 2024-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k240369-cac-gated-algorithm-fda-510k.jpg K240369 - CAC (gated) Algorithm K240369 is a FDA 510(k) cleared radiology medical device. Manufacturer: BunkerHill Health. Cleared Sep 2024. https://www.510kdatabase.net/k240745/ 2024-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k240745-id-free-personal-lubricant-fda-510k.jpg K240745 - ID Free Personal Lubricant K240745 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Westridge Laboratories, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k240993/ 2024-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k240993-encevis-21-fda-510k.jpg K240993 - encevis (2.1) K240993 is a FDA 510(k) cleared neurology medical device. Manufacturer: Ait Austrian Institute of Technology GmbH. Cleared Sep 2024. https://www.510kdatabase.net/k241447/ 2024-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k241447-icare-st500-ta04-fda-510k.jpg K241447 - iCare ST500 (TA04) K241447 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Icare Finland OY. Cleared Sep 2024. https://www.510kdatabase.net/k241480/ 2024-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k241480-jbs-lvo-fda-510k.jpg K241480 - JBS-LVO K241480 is a FDA 510(k) cleared radiology medical device. Manufacturer: JLK, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k241513/ 2024-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k241513-sourcerer-fda-510k.jpg K241513 - Sourcerer K241513 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brain Electrophysiology Laboratory Company, LLC. Cleared Sep 2024. https://www.510kdatabase.net/k241536/ 2024-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k241536-trophon-wireless-ultrasound-probe-holder-fda-510k.jpg K241536 - trophon Wireless Ultrasound Probe Holder K241536 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Nanosonics Limited. Cleared Sep 2024. https://www.510kdatabase.net/k241909/ 2024-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k241909-halyard-purple-nitrile-powder-free-fda-510k.jpg K241909 - Halyard Purple Nitrile* Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid K241909 is a FDA 510(k) cleared general hospital medical device. Manufacturer: O&M Halyard, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k241916/ 2024-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k241916-tearrepair-liquid-skin-protectant-fda-510k.jpg K241916 - TearRepair Liquid Skin Protectant K241916 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Optmed, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k241933/ 2024-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k241933-higherdose-red-and-infrared-light-mask-fda-510k.jpg K241933 - HIGHERDOSE Red and Infrared Light Mask (MK66-L) K241933 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Kaiyan Medical Equipment Co., Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k241939/ 2024-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k241939-easycare-tx-2-fda-510k.jpg K241939 - EasyCare Tx 2 K241939 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: ResMed Corp. Cleared Sep 2024. https://www.510kdatabase.net/k242125/ 2024-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k242125-elvie-stride-2-fda-510k.jpg K242125 - Elvie Stride 2 K242125 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Chiaro Technology, Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k242206/ 2024-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k242206-activo-fda-510k.jpg K242206 - ACTIVO K242206 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Daeju Meditech Engineering Co., Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k242213/ 2024-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k242213-shockwave-intravascular-lithotripsy-fda-510k.jpg K242213 - Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter K242213 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shockwave Medical, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k242540/ 2024-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k242540-alltest-multi-drug-urine-test-panel-fda-510k.jpg K242540 - AllTest Multi-Drug Urine Test Panel K242540 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Hangzhou AllTest Biotech Co., Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k242557/ 2024-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k242557-clottriever-xl-catheter-41-102-fda-510k.jpg K242557 - ClotTriever XL Catheter (41-102) K242557 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inari Medical, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k242571/ 2024-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k242571-secret-line-up-fc1938e80-fc1950e90-fda-510k.jpg K242571 - Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150 FC19100E150 FC19100E280 FC19100E420 FC2038E80 FC2050E90 FC2060E100 FC2070E120 FC2090E150 FC20100E170 FC2138G80 FC2150G90 FC2160G100 FC2170G120 FC2190G150 FC21100G170 FCL18100C160 FCL1938E80 FCL1950E90 FCL1960E100 FCL1970E120 FCL1990E150 FCL19100E160 FCL2138G80 FCL2150G90 FCL2160G100 FCL2170G120 FCL2190G150 FCL21100G160 FCRL1870C162 FCRL18100C185 FCRL1970E162 FCRL19100E185 FCHL1960E90 FCHL1970E120 FCHL19100E160 FCW1938 K242571 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Hyundae Meditech Co., Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k242582/ 2024-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k242582-optima-coil-system-optiblock-line-fda-510k.jpg K242582 - Optima Coil System (OptiBlock Line Extension) K242582 is a FDA 510(k) cleared neurology medical device. Manufacturer: Balt USA, LLC. Cleared Sep 2024. https://www.510kdatabase.net/den240017/ 2024-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/den240017-shortcut-fda-510k.jpg DEN240017 - ShortCut DEN240017 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Pi-Cardia, Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k234149/ 2024-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k234149-molli-2-system-fda-510k.jpg K234149 - MOLLI 2 System K234149 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Molli Surgical, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k240854/ 2024-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k240854-accelerate-arc-system-fda-510k.jpg K240854 - Accelerate Arc System K240854 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Accelerate Diagnostics, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k241027/ 2024-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k241027-permatage-settable-bone-putty-fda-510k.jpg K241027 - Permatage Settable Bone Putty K241027 is a FDA 510(k) cleared neurology medical device. Manufacturer: Orthocon, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k241101/ 2024-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k241101-biobutton-system-fda-510k.jpg K241101 - BioButton System K241101 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biointellisense, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k241147/ 2024-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k241147-any-com-fda-510k.jpg K241147 - Any-Com K241147 is a FDA 510(k) cleared dental medical device. Manufacturer: Mediclus Co., Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k241216/ 2024-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k241216-myair-fda-510k.jpg K241216 - myAir K241216 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: ResMed Corp. Cleared Sep 2024. https://www.510kdatabase.net/k241341/ 2024-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k241341-cryo-go-vitrification-device-fda-510k.jpg K241341 - cryo-GO Vitrification Device K241341 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Fujifilm Irvine Scientific. Cleared Sep 2024. https://www.510kdatabase.net/k241414/ 2024-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k241414-crosswise-rf-transseptal-access-system-fda-510k.jpg K241414 - CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C) K241414 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Circa Scientific, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k241651/ 2024-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k241651-affixus-tibial-and-antegrade-femoral-fda-510k.jpg K241651 - Affixus Tibial and Antegrade Femoral Nailing System K241651 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k241815/ 2024-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k241815-protean-fragment-plating-system-fda-510k.jpg K241815 - Protean Fragment Plating System K241815 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Skeletal Dynamics, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k241827/ 2024-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k241827-microwave-ablation-generator-ky-2000a-fda-510k.jpg K241827 - Microwave Ablation Generator (KY-2000A, KY-2100A) K241827 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Canyon Medical, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k241895/ 2024-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k241895-cannulated-psifguard-fda-510k.jpg K241895 - Cannulated PsiFGuard K241895 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spineguard. Cleared Sep 2024. https://www.510kdatabase.net/k242632/ 2024-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k242632-verifine-pen-needles-fda-510k.jpg K242632 - Verifine® Pen Needles K242632 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Promisemed Hangzhou Meditech Co., Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k240041/ 2024-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k240041-ivd-capsule-psp-fda-510k.jpg K240041 - IVD CAPSULE PSP K240041 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abionic SA. Cleared Sep 2024. https://www.510kdatabase.net/k240042/ 2024-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k240042-molli-2-system-fda-510k.jpg K240042 - MOLLI 2 System K240042 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Molli Surgical, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k240434/ 2024-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k240434-relieev-suction-curette-flexible-30-fda-510k.jpg K240434 - RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6) K240434 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Li Medical Corporation , Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k241535/ 2024-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k241535-vybe-rf-ii-fda-510k.jpg K241535 - Vybe RF II K241535 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: ShenB Co., Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k241860/ 2024-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k241860-diode-laser-hair-removal-system-fda-510k.jpg K241860 - Diode Laser Hair Removal System K241860 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Beijing Winkonlaser Technology Limited. Cleared Sep 2024. https://www.510kdatabase.net/k242075/ 2024-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k242075-indigo-aspiration-system-lightning-fda-510k.jpg K242075 - Indigo® Aspiration System – Lightning Bolt Aspiration Tubing K242075 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Penumbra, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k242204/ 2024-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k242204-disposable-neutral-electrodes-gp201b-a-fda-510k.jpg K242204 - Disposable Neutral Electrodes (GP201B-A, GP202B-A, GP202B-P, GP202B-I, GP202M-A, GP202M-P, GP202M-I, GP202B-AC, GP202B-PC, GP202B-IC, GP202M-AC, GP202M-PC, GP202M-IC, GP203M-A, GP203B-A, GP203M-AC, GP203B-AC, GP203M-P, GP203B-P, GP203M-PC, GP203B-PC, GP203M-I, GP203B-I, GP203M-IC, GP203B-IC) K242204 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Dongguan Quanding Medical Supplies Co., Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k242273/ 2024-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k242273-cove-putty-osteocove-putty-fda-510k.jpg K242273 - Cove Putty, OsteoCove Putty K242273 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared Sep 2024. https://www.510kdatabase.net/k242299/ 2024-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k242299-novabone-putty-synthetic-bioactive-fda-510k.jpg K242299 - NovaBone Putty - Synthetic Bioactive Bone Graft K242299 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Novabone Products, LLC. Cleared Sep 2024. https://www.510kdatabase.net/k233807/ 2024-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k233807-lumivy-lumbar-ibf-system-fda-510k.jpg K233807 - LumiVy™ Lumbar IBF System K233807 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Vy Spine, LLC. Cleared Sep 2024. https://www.510kdatabase.net/k234134/ 2024-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k234134-airfit-f30i-mask-system-fda-510k.jpg K234134 - AirFit F30i Mask System K234134 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Resmed Pty Ltd (Registration Number: 3004604967). Cleared Sep 2024. https://www.510kdatabase.net/k240236/ 2024-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k240236-happy-ring-health-monitoring-system-fda-510k.jpg K240236 - Happy Ring Health Monitoring System K240236 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Happy Health, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k240776/ 2024-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k240776-celsio-flexible-cryocatheter-system-fda-510k.jpg K240776 - Celsio Flexible Cryocatheter System K240776 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Endocision Technologies, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k241874/ 2024-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k241874-aspiration-catheter-2189-fda-510k.jpg K241874 - Aspiration Catheter (2189) K241874 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hobbs Medical, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k242070/ 2024-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k242070-ion-endoluminal-system-if-1000-fda-510k.jpg K242070 - Ion Endoluminal System (IF 1000) K242070 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k242292/ 2024-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k242292-uai-easy-triage-ich-fda-510k.jpg K242292 - uAI Easy Triage ICH K242292 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Intelligence Co., Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k240013/ 2024-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k240013-echogo-heart-failure-20-fda-510k.jpg K240013 - EchoGo Heart Failure (2.0) K240013 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ultromics Limited. Cleared Sep 2024. https://www.510kdatabase.net/k240243/ 2024-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k240243-econsole2-fda-510k.jpg K240243 - EConsole2 K240243 is a FDA 510(k) cleared radiology medical device. Manufacturer: DRTECH Corporation. Cleared Sep 2024. https://www.510kdatabase.net/k241570/ 2024-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k241570-unity-total-knee-system-fda-510k.jpg K241570 - Unity Total Knee System K241570 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corin U.S.A. Limited. Cleared Sep 2024. https://www.510kdatabase.net/k241834/ 2024-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k241834-ipl-hair-removal-device-be932c-be932d-fda-510k.jpg K241834 - IPL Hair Removal Device (BE932C, BE932D, BE932E) K241834 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Yang WO Electronic Co., Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k232670/ 2024-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k232670-hicardi-h100-fda-510k.jpg K232670 - HiCardi+ H100 K232670 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: MEZOO Co., Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k233153/ 2024-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k233153-traus-ssg10-surgical-system-fda-510k.jpg K233153 - Traus SSG10 Surgical System K233153 is a FDA 510(k) cleared neurology medical device. Manufacturer: Saeshin Precision Co., Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k234108/ 2024-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k234108-eri-portable-x-ray-system-cvx-air-fda-510k.jpg K234108 - ERI Portable X-ray System (CVX-air) K234108 is a FDA 510(k) cleared radiology medical device. Manufacturer: Energy Resources International Co., Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k234129/ 2024-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k234129-ecomed-disposable-administration-sets-fda-510k.jpg K234129 - Ecomed Disposable Administration Sets K234129 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ecomed Solutions, LLC. Cleared Sep 2024. https://www.510kdatabase.net/k240036/ 2024-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k240036-piur-tus-infinity-fda-510k.jpg K240036 - PIUR tUS Infinity K240036 is a FDA 510(k) cleared radiology medical device. Manufacturer: Piur Imaging GmbH. Cleared Sep 2024. https://www.510kdatabase.net/k240061/ 2024-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k240061-trigen-max-tibial-nail-system-fda-510k.jpg K240061 - TRIGEN MAX Tibial Nail System K240061 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k240420/ 2024-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k240420-neurofield-analysis-suite-fda-510k.jpg K240420 - NeuroField Analysis Suite K240420 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neurofield, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k240604/ 2024-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k240604-mtone-evo-mtone-evo-fda-510k.jpg K240604 - MTONE EVO (MTONE EVO) K240604 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: M&T S.R.L.. Cleared Sep 2024. https://www.510kdatabase.net/k240722/ 2024-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k240722-derma-r-cream-derma-r-cream-fda-510k.jpg K240722 - Derma-R Cream (Derma-R Cream) K240722 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Raya Pharmaceuticals, LLC. Cleared Sep 2024. https://www.510kdatabase.net/k241332/ 2024-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k241332-aprevo-anterior-and-lateral-lumbar-fda-510k.jpg K241332 - aprevo® anterior and lateral lumbar interbody fusion device K241332 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Carlsmed, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k241821/ 2024-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k241821-luer-lock-syringe-with-safety-needle-fda-510k.jpg K241821 - Luer Lock Syringe with Safety Needle K241821 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sol-Millennium Medical, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k241825/ 2024-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k241825-microwave-ablation-antennas-fda-510k.jpg K241825 - Microwave Ablation Antennas K241825 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Canyon Medical, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k241880/ 2024-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k241880-air-powered-tooth-polishing-system-fda-510k.jpg K241880 - Air Powered Tooth Polishing System (Perio-Mate) K241880 is a FDA 510(k) cleared dental medical device. Manufacturer: Nakanishi, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k242147/ 2024-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k242147-calibrate-ltx-interbody-system-fda-510k.jpg K242147 - Calibrate LTX Interbody System K242147 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k242223/ 2024-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k242223-supersonic-hepavu-fda-510k.jpg K242223 - SuperSonic HepaVu K242223 is a FDA 510(k) cleared radiology medical device. Manufacturer: Supersonic Imagine. Cleared Sep 2024. https://www.510kdatabase.net/k242504/ 2024-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k242504-millipede-088-access-catheter-fda-510k.jpg K242504 - Millipede 088 Access Catheter K242504 is a FDA 510(k) cleared neurology medical device. Manufacturer: Perfuze, Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k242650/ 2024-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k242650-zlock-lumbar-facet-fixation-system-fda-510k.jpg K242650 - zLOCK Lumbar Facet Fixation System K242650 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zygofix , Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k234096/ 2024-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k234096-monostereo-fda-510k.jpg K234096 - MonoStereo K234096 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Medicaltek Co., Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k240183/ 2024-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k240183-star-e900-handpiece-series-fda-510k.jpg K240183 - Star E900 Handpiece Series K240183 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentalez, Inc., Stardental Division. Cleared Sep 2024. https://www.510kdatabase.net/k240901/ 2024-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k240901-stethophone-fda-510k.jpg K240901 - Stethophone K240901 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sparrow Acoustics, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k241465/ 2024-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k241465-midas-flowmeter-fda-510k.jpg K241465 - Midas Flowmeter K241465 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Parker Hannifin Corporation. Cleared Sep 2024. https://www.510kdatabase.net/k241709/ 2024-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k241709-pectus-blu-support-bar-system-fda-510k.jpg K241709 - Pectus Blu Support Bar System K241709 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet Microfixation. Cleared Sep 2024. https://www.510kdatabase.net/k242162/ 2024-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k242162-coconut-hybrid-fda-510k.jpg K242162 - Coconut Hybrid K242162 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Good Clean Love, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k242167/ 2024-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k242167-sterile-and-non-sterile-ultrasonic-fda-510k.jpg K242167 - Sterile and Non-Sterile Ultrasonic Coupling Agent K242167 is a FDA 510(k) cleared radiology medical device. Manufacturer: Anhui Deepblue Medical Technology Co., Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k242478/ 2024-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k242478-gf85-models-gf85-3p-gf85-sp-fda-510k.jpg K242478 - GF85 (models GF85-3P, GF85-SP) K242478 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Electronics Co., Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k242509/ 2024-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k242509-hanano-interfuser-modular-interbody-fda-510k.jpg K242509 - HAnano InterFuse(R) Modular Interbody K242509 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Next Orthosurgical. Cleared Sep 2024. https://www.510kdatabase.net/k231383/ 2024-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k231383-terragene-bionova-self-contained-fda-510k.jpg K231383 - Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator (BT96), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40) K231383 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terragene S.A.. Cleared Sep 2024. https://www.510kdatabase.net/k231893/ 2024-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k231893-lowtem-crystal-120-fda-510k.jpg K231893 - LOWTEM Crystal 120 K231893 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Lowtem Co., Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k233064/ 2024-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k233064-copra-supreme-fda-510k.jpg K233064 - Copra Supreme K233064 is a FDA 510(k) cleared dental medical device. Manufacturer: Whitepeaks Dental Solutions GmbH. Cleared Sep 2024. https://www.510kdatabase.net/k234142/ 2024-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k234142-tigen-abutment-pmma-abutment-and-scan-fda-510k.jpg K234142 - TiGEN Abutment, PMMA Abutment and Scan Healing Abutment K234142 is a FDA 510(k) cleared dental medical device. Manufacturer: Megagen Implant Co., Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k234153/ 2024-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k234153-edgelife-handheld-wireless-ultrasound-fda-510k.jpg K234153 - EdgeLife Handheld Wireless Ultrasound System (E8200) K234153 is a FDA 510(k) cleared radiology medical device. Manufacturer: Edgelife Technologies, LLC. Cleared Sep 2024. https://www.510kdatabase.net/k241123/ 2024-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k241123-perpak-sterilization-tyvek-pouch-fda-510k.jpg K241123 - Perpak™ Sterilization Tyvek Pouch K241123 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Km Corp.. Cleared Sep 2024. https://www.510kdatabase.net/k241424/ 2024-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k241424-innocare-specialty-foley-catheter-fda-510k.jpg K241424 - InnoCare Specialty Foley Catheter K241424 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Innocare Urologics, LLC. Cleared Sep 2024. https://www.510kdatabase.net/k241769/ 2024-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k241769-response-ortho-metaphyseal-hinge-fda-510k.jpg K241769 - Response Ortho Metaphyseal Hinge Fixator System K241769 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Response Ortho Solutions, LLC. Cleared Sep 2024. https://www.510kdatabase.net/k241775/ 2024-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k241775-xelitemed-vertehighfix-high-viscosity-fda-510k.jpg K241775 - XeliteMed VertehighFix High Viscosity Spinal Bone Cement K241775 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Xelite Biomed , Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k241784/ 2024-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k241784-arrow-nitinol-wire-fda-510k.jpg K241784 - Arrow® Nitinol Wire K241784 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Teleflex Medical. Cleared Sep 2024. https://www.510kdatabase.net/k233721/ 2024-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k233721-kls-martin-drill-free-mmf-screw-fda-510k.jpg K233721 - KLS Martin Drill-Free MMF Screw K233721 is a FDA 510(k) cleared dental medical device. Manufacturer: KLS-Martin L.P.. Cleared Sep 2024. https://www.510kdatabase.net/k234132/ 2024-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k234132-medline-reusable-sterilization-wrappers-fda-510k.jpg K234132 - Medline Reusable Sterilization Wrappers K234132 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, LP. Cleared Sep 2024. https://www.510kdatabase.net/k240250/ 2024-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k240250-3d-printed-peek-interbody-system-fda-510k.jpg K240250 - 3D Printed PEEK Interbody System K240250 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nvision Biomedical Technologies, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k240274/ 2024-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k240274-padlock-clip-eftr-kit-00713229-fda-510k.jpg K240274 - PADLOCK CLIP EFTR Kit (00713229) K240274 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: STERIS Corporation. Cleared Sep 2024. https://www.510kdatabase.net/k240293/ 2024-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k240293-sts-fda-510k.jpg K240293 - STS K240293 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Techbopulm, Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k240373/ 2024-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k240373-air-compression-leg-massager-mm0520-fda-510k.jpg K240373 - Air compression Leg Massager (MM0520, MM0521, MM0522) K240373 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zhangzhou Easepal Medical Science and Technology Co., Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k240660/ 2024-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k240660-signum-composite-flow-fda-510k.jpg K240660 - Signum composite flow K240660 is a FDA 510(k) cleared dental medical device. Manufacturer: Kulzer, LLC. Cleared Sep 2024. https://www.510kdatabase.net/k240689/ 2024-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k240689-robins-egg-fda-510k.jpg K240689 - Robin's Egg K240689 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Telebrands Corporation. Cleared Sep 2024. https://www.510kdatabase.net/k241230/ 2024-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k241230-super-sheath-introducer-sheath-s-fda-510k.jpg K241230 - Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008 K241230 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Togo Medikit Co., Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k241942/ 2024-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k241942-trimed-bridge-plates-fda-510k.jpg K241942 - TriMed Bridge Plates K241942 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: TriMed, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k242186/ 2024-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k242186-neo-sculptor-of-neo001-fda-510k.jpg K242186 - Neo Sculptor (OF-NEO001) K242186 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Ofan Intelligent Technology (Guangzhou) Co. , Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k232938/ 2024-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k232938-traus-ssg30-surgical-system-fda-510k.jpg K232938 - Traus SSG30 Surgical System K232938 is a FDA 510(k) cleared neurology medical device. Manufacturer: Saeshin Precision Co., Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k234050/ 2024-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k234050-halyard-one-step-sterilization-wrap-fda-510k.jpg K234050 - HALYARD® ONE-STEP® Sterilization Wrap, HALYARD® QUICK CHECK® Sterilization Wrap, HALYARD® SEQUENTIAL Sterilization Wrap and HALYARD® SMART-FOLD® Sterilization Wrap K234050 is a FDA 510(k) cleared general hospital medical device. Manufacturer: O&M Halyard, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k234089/ 2024-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k234089-dna-appliance-fda-510k.jpg K234089 - DNA Appliance K234089 is a FDA 510(k) cleared dental medical device. Manufacturer: Vivos Therapeutics. Cleared Sep 2024. https://www.510kdatabase.net/k240638/ 2024-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k240638-power-wheelchair-yh-e7007-fda-510k.jpg K240638 - Power Wheelchair (YH-E7007) K240638 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Ningbo Youhuan Automation Technology Co., Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k241201/ 2024-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k241201-tex20tex20-protex20stex20ttex20-fda-510k.jpg K241201 - TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite/Anesus TEX20 Pro/Eagus TEX20/Eagus TEX20T/Eagus TEX21/Eagus TEX21T/Eros/TE X Plus/Anesus TEX10 Pro/TEX9U/TEX9M/Eagus TEX11/Eagus TEX11T/EagusTEX10/Eagus TEX10T/Eagus TEX/Ares Diagnostic Ultrasound System K241201 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k241335/ 2024-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k241335-eversense-365-continuous-glucose-fda-510k.jpg K241335 - Eversense 365 Continuous Glucose Monitoring (CGM) System K241335 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Senseonics, Incorporated. Cleared Sep 2024. https://www.510kdatabase.net/k241379/ 2024-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k241379-powered-wheelchair-nxn20-205-nxn20-205m-fda-510k.jpg K241379 - Powered Wheelchair (NXN20-205, NXN20-205M) K241379 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zhejiang Nysin Medical Co., Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k241762/ 2024-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k241762-onemark-fda-510k.jpg K241762 - OneMark K241762 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: View Point Medical. Cleared Sep 2024. https://www.510kdatabase.net/k241771/ 2024-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k241771-liftendo-fda-510k.jpg K241771 - Liftendo K241771 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medical San Ind?stria DE Equipamentos M?dicos Ltda.. Cleared Sep 2024. https://www.510kdatabase.net/k241893/ 2024-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k241893-crossnav-navigation-enabled-fda-510k.jpg K241893 - CROSSNAV Navigation Enabled Instruments and UNAS Navigation Arrays K241893 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International SARL. Cleared Sep 2024. https://www.510kdatabase.net/k241156/ 2024-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k241156-medline-renewal-reprocessed-st-jude-fda-510k.jpg K241156 - Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter, Supreme Electrophysiology Catheter (401150, 401206, 401207, 401210, 401211, 401212, 401222, 401223, 401226, 401227, 401228, 401260, 401261, 401271, 401305, 401306, 401309, 401310, 401311, 401312, 401317, 401353, 401357, 401381, 401392, 401399, 401400, 401425, 401430, 401433, 401434, 401435, 401436, 401438, 401441, 401442, 401443, 401444, 401445, 401448, 401449, 401450, 401451, 401453, 401466, 401468, 401 K241156 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Surgical Instrument Service and Savings, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k233399/ 2024-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k233399-microdacyn-wound-care-solution-fda-510k.jpg K233399 - Microdacyn Wound Care Solution K233399 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sonoma Pharmaceuticals, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k234063/ 2024-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k234063-t2candida-11-panel-fda-510k.jpg K234063 - T2Candida 1.1 Panel K234063 is a FDA 510(k) cleared microbiology medical device. Manufacturer: T2biosystems, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k240087/ 2024-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k240087-rt-carbon-ecg-leads-fda-510k.jpg K240087 - RT Carbon ECG Leads K240087 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ivy Biomedical Systems, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k240176/ 2024-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k240176-v-vitfreeze-and-v-vitwarm-fda-510k.jpg K240176 - V-VITFREEZE and V-VITWARM K240176 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Vitromed GmbH. Cleared Sep 2024. https://www.510kdatabase.net/k240188/ 2024-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k240188-vitruvian-liposaber-fda-510k.jpg K240188 - Vitruvian Liposaber K240188 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Black & Black Surgical, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k240232/ 2024-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k240232-ek-d33-and-ultra-wide-implants-fda-510k.jpg K240232 - EK D3.3 and Ultra Wide Implants K240232 is a FDA 510(k) cleared dental medical device. Manufacturer: Hiossen, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k240544/ 2024-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k240544-epitomee-fda-510k.jpg K240544 - Epitomee K240544 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Epitomee Medical , Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k240929/ 2024-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k240929-sleep-apnea-notification-feature-sanf-fda-510k.jpg K240929 - Sleep Apnea Notification Feature (SANF) K240929 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Apple, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k240977/ 2024-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k240977-denq-sub-sla-implant-system-fda-510k.jpg K240977 - DenQ Sub SLA Implant System K240977 is a FDA 510(k) cleared dental medical device. Manufacturer: Denq. Cleared Sep 2024. https://www.510kdatabase.net/k241722/ 2024-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k241722-elos-accurate-hybrid-base-fda-510k.jpg K241722 - Elos Accurate® Hybrid Base™ K241722 is a FDA 510(k) cleared dental medical device. Manufacturer: Elos Medtech Pinol A/S. Cleared Sep 2024. https://www.510kdatabase.net/k241875/ 2024-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k241875-theray-collared-and-collarless-femoral-fda-510k.jpg K241875 - TheRay Collared and Collarless Femoral Stem K241875 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nextstep Arthropedix. Cleared Sep 2024. https://www.510kdatabase.net/k242441/ 2024-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k242441-revian-lyte-10011-fda-510k.jpg K242441 - Revian Lyte (10011) K242441 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Revian, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k220999/ 2024-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k220999-hipro-glycosylated-hemoglobin-hba1c-fda-510k.jpg K220999 - Hipro Glycosylated Hemoglobin (HbA1c) Test System K220999 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Shijiazhuang Hipro Biotechnology Co., Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k231982/ 2024-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k231982-quantum-perfusion-blood-oxygenator-fda-510k.jpg K231982 - Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2 K231982 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Qura S.R.L. Cleared Sep 2024. https://www.510kdatabase.net/k233732/ 2024-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k233732-coolsculpting-elite-system-fda-510k.jpg K233732 - CoolSculpting Elite System K233732 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics. Cleared Sep 2024. https://www.510kdatabase.net/k240168/ 2024-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k240168-n7-s-fda-510k.jpg K240168 - N7-S K240168 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Nuga Medical Co., Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k240787/ 2024-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k240787-selectra-3d-lead-delivery-system-fda-510k.jpg K240787 - Selectra 3D Lead Delivery System (443624-443629, 451789-451791) K240787 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biotronik, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k240803/ 2024-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k240803-surgikor-fixation-one-abutment-blanks-fda-510k.jpg K240803 - Surgikor Fixation One, Abutment Blanks and Abutments K240803 is a FDA 510(k) cleared dental medical device. Manufacturer: Surgikor, LLC. Cleared Sep 2024. https://www.510kdatabase.net/k240880/ 2024-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k240880-vitalflow-set-with-balance-biosurface-fda-510k.jpg K240880 - VitalFlow Set with Balance Biosurface K240880 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k240942/ 2024-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k240942-cina-cspine-fda-510k.jpg K240942 - CINA-CSpine K240942 is a FDA 510(k) cleared radiology medical device. Manufacturer: Avicenna.Ai. Cleared Sep 2024. https://www.510kdatabase.net/k241249/ 2024-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k241249-orthopantomograph-op-3d-lx-pan-3d-fda-510k.jpg K241249 - Orthopantomograph™ OP 3D LX (PAN 3D) K241249 is a FDA 510(k) cleared radiology medical device. Manufacturer: Palodex Group OY. Cleared Sep 2024. https://www.510kdatabase.net/k241280/ 2024-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k241280-constellation-con-001-fda-510k.jpg K241280 - Constellation (CON-001) K241280 is a FDA 510(k) cleared radiology medical device. Manufacturer: Q Bio, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k241432/ 2024-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k241432-mx7mx7tvaus7zeusme7anesus-me7anesus-fda-510k.jpg K241432 - MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX7P/MX7W/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System K241432 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k241493/ 2024-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k241493-glidewell-3dp-denture-base-resin-fda-510k.jpg K241493 - Glidewell™ 3DP Denture Base Resin K241493 is a FDA 510(k) cleared dental medical device. Manufacturer: Prismatik Dentalcraft, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k241524/ 2024-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k241524-elucid-plaqueiq-fda-510k.jpg K241524 - Elucid PlaqueIQ K241524 is a FDA 510(k) cleared radiology medical device. Manufacturer: Elucid Bioimaging, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k241582/ 2024-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k241582-aplio-i900i800i700-diagnostic-fda-510k.jpg K241582 - Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 (TUS-AI900, TUS-AI800, TUS-AI700) K241582 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Sep 2024. https://www.510kdatabase.net/k241695/ 2024-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k241695-extremity-all-suture-system-fda-510k.jpg K241695 - Extremity All Suture System K241695 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Field Orthopaedics. Cleared Sep 2024. https://www.510kdatabase.net/k241710/ 2024-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k241710-3m-attest-super-rapid-readout-fda-510k.jpg K241710 - 3M™ Attest™ Super Rapid Readout Biological Indicator 1492V K241710 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Sep 2024. https://www.510kdatabase.net/k242136/ 2024-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k242136-electric-wheelchair-c001-fda-510k.jpg K242136 - Electric wheelchair (C001) K242136 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zhejiang Hfizer Medical Equipment Co., Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k242401/ 2024-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k242401-exult-knee-replacement-system-fda-510k.jpg K242401 - EXULT Knee Replacement System K242401 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corentec Co., Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/den230081/ 2024-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/den230081-hearing-aid-feature-haf-fda-510k.jpg DEN230081 - Hearing Aid Feature (HAF) DEN230081 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Apple, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k232559/ 2024-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k232559-cb-nfh-hybrid-fda-510k.jpg K232559 - C&B NFH Hybrid K232559 is a FDA 510(k) cleared dental medical device. Manufacturer: Arum Dentistry Co., Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k240271/ 2024-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k240271-linshom-continuous-predictive-fda-510k.jpg K240271 - Linshom Continuous Predictive Respiratory Monitoring System (CPRMS) K240271 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Linshom Medical, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k240683/ 2024-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k240683-rx-knee-system-fda-510k.jpg K240683 - Rx Knee System K240683 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Signature Orthopaedics Pty, Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k241004/ 2024-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k241004-wearable-breast-pump-abp-1508pro-abp-fda-510k.jpg K241004 - Wearable Breast Pump (ABP-1508PRO, ABP-1506, ABP-1306, ABP-1306 PRO, M1, M3, M8, M5, M6, K1, K2, K3, K5, ABP-1306PLUS, ABP-1308, M2) K241004 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Huizhou Lvb Maternal and Infant Supplies Co., Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k241010/ 2024-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k241010-healix-advance-knotless-anchors-fda-510k.jpg K241010 - HEALIX ADVANCE Knotless anchors K241010 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Mitek. Cleared Sep 2024. https://www.510kdatabase.net/k241161/ 2024-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k241161-ultrasound-imaging-system-lk128l-fda-510k.jpg K241161 - Ultrasound Imaging System (LK128L) K241161 is a FDA 510(k) cleared radiology medical device. Manufacturer: Leltek, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k241362/ 2024-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k241362-pounce-xl-thrombectomy-system-pts-1011-fda-510k.jpg K241362 - Pounce XL Thrombectomy System (PTS-1011-7F135) K241362 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Surmodics,Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k241380/ 2024-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k241380-fetoly-heart-fda-510k.jpg K241380 - FETOLY-HEART K241380 is a FDA 510(k) cleared radiology medical device. Manufacturer: Diagnoly. Cleared Sep 2024. https://www.510kdatabase.net/k241438/ 2024-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k241438-signus-tetris-st-fda-510k.jpg K241438 - Signus Tetris™ St K241438 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Signus Medizintechnik GmbH. Cleared Sep 2024. https://www.510kdatabase.net/k241745/ 2024-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k241745-powder-free-nitrile-examination-glove-fda-510k.jpg K241745 - Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with 46 Chemotherapy Drugs, the Opioid Fentanyl citrate, simulated Gastric Acid, Fentanyl in Gastric Acid, the tranquilizer Xylazine, and Xylazine in Fentanyl citrate (Blue) K241745 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ksg Medicare Sdn. Bhd.. Cleared Sep 2024. https://www.510kdatabase.net/k241954/ 2024-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k241954-sonoblock-fda-510k.jpg K241954 - SonoBlock K241954 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: PAJUNK GmbH Medizintechnologie. Cleared Sep 2024. https://www.510kdatabase.net/k234064/ 2024-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k234064-medline-renewal-reprocessed-siemens-fda-510k.jpg K234064 - Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens Systems) (10135936) K234064 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Surgical Instrument Service and Savings, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k240094/ 2024-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k240094-lumine-us-fda-510k.jpg K240094 - LumiNE US K240094 is a FDA 510(k) cleared radiology medical device. Manufacturer: Augmedit B.V.. Cleared Sep 2024. https://www.510kdatabase.net/k240990/ 2024-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k240990-mobility-scooter-fda-510k.jpg K240990 - Mobility Scooter K240990 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zhejiang Innuovo Rehabilitation Devices Co.,Ltd. Cleared Sep 2024. https://www.510kdatabase.net/k241214/ 2024-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k241214-propel-sg3-surgical-gown-fda-510k.jpg K241214 - ProPel SG3™ Surgical Gown K241214 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Standard Textile Co., Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k241609/ 2024-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k241609-tornier-humeral-reconstruction-system-fda-510k.jpg K241609 - Tornier Humeral Reconstruction System (Tornier HRS) K241609 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Corporation (Tornier, Inc.). Cleared Sep 2024. https://www.510kdatabase.net/k241638/ 2024-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k241638-8mm-sureform-30-curved-tip-stapler-fda-510k.jpg K241638 - 8mm SureForm 30 Curved-Tip Stapler K241638 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k242612/ 2024-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k242612-option-elite-vena-cava-filter-system-fda-510k.jpg K242612 - Option ELITE Vena Cava Filter System (352506070E 352506100E) K242612 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Argon Medical Devices, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k240233/ 2024-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k240233-pitkar-spinal-pedicle-screw-system-fda-510k.jpg K240233 - Pitkar Spinal Pedicle Screw System K240233 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: S.H.Pitkar Orthotools Pvt. , Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k240266/ 2024-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k240266-latex-examination-glove-powder-free-fda-510k.jpg K240266 - Latex Examination Glove Powder Free (Ocean Blue and Natural White) K240266 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sri Trang Gloves (Thailand) Public Company Limited. Cleared Sep 2024. https://www.510kdatabase.net/k240697/ 2024-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k240697-see-mode-augmented-reporting-tool-fda-510k.jpg K240697 - See-Mode Augmented Reporting Tool, Thyroid (SMART-T) K240697 is a FDA 510(k) cleared radiology medical device. Manufacturer: See-Mode Technologies Pte, Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k240791/ 2024-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k240791-adas-3d-fda-510k.jpg K240791 - ADAS 3D K240791 is a FDA 510(k) cleared radiology medical device. Manufacturer: Adas3D Medical S.L.. Cleared Sep 2024. https://www.510kdatabase.net/k241205/ 2024-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k241205-ice-cooling-ipl-hair-removal-device-fda-510k.jpg K241205 - Ice Cooling IPL Hair Removal Device (Y6S GR, Y6S GA,Y6S GT, Y6S JU, Y6S JM, Y6S MU, Y6S OG, Y6S CH,Y6S PN,Y6S NK, Y6S PG, Y6S TG, Y6S OE) K241205 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Ulike Smart Electronics Co., Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k241678/ 2024-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k241678-tens-ems-stimulator-mhd-1083-fda-510k.jpg K241678 - TENS & EMS Stimulator (MHD-1083) K241678 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Minghuangda Electronics Co., Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k241681/ 2024-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k241681-overjet-image-enhancement-assist-fda-510k.jpg K241681 - Overjet Image Enhancement Assist K241681 is a FDA 510(k) cleared radiology medical device. Manufacturer: Overjet, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k242042/ 2024-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k242042-trialtis-spine-system-fda-510k.jpg K242042 - TriALTIS™ Spine System K242042 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International SARL. Cleared Sep 2024. https://www.510kdatabase.net/k242349/ 2024-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k242349-folix-fda-510k.jpg K242349 - FoLix K242349 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lumenis Be, Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k242394/ 2024-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k242394-digital-flat-panel-x-ray-detector-fda-510k.jpg K242394 - Digital Flat Panel X-ray Detector (1717WCE, 1717WCE-HR, 1717WCE-HS, 1717WCE-GF) K242394 is a FDA 510(k) cleared radiology medical device. Manufacturer: Rayence Co., Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k240486/ 2024-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k240486-pm2-system-and-ecguide-connector-fda-510k.jpg K240486 - PM2 System and ECGuide Connector K240486 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Piccolo Medical, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k231667/ 2024-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k231667-withings-sleep-rx-fda-510k.jpg K231667 - Withings Sleep Rx K231667 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Withings. Cleared Sep 2024. https://www.510kdatabase.net/k232543/ 2024-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k232543-msc-sfm-fda-510k.jpg K232543 - MSC SFM K232543 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Yocon Biology Technology Company. Cleared Sep 2024. https://www.510kdatabase.net/k232996/ 2024-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k232996-iatrical-interbody-lumbar-fusion-fda-510k.jpg K232996 - Iatrical Interbody Lumbar Fusion Systems (Model ALIF, Model TLIF, Model LLIF) K232996 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Shanghai Iatrical-Ti Technologies CO , Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k233806/ 2024-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k233806-t2-plus-fda-510k.jpg K233806 - T2 Plus K233806 is a FDA 510(k) cleared radiology medical device. Manufacturer: Osstem Implant Co., Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k233900/ 2024-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k233900-nordica-pv-cryo-mapping-catheter-fda-510k.jpg K233900 - Nordica PV Cryo Mapping Catheter K233900 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Synaptic Medical Corporation. Cleared Sep 2024. https://www.510kdatabase.net/k233911/ 2024-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k233911-visulas-combi-fda-510k.jpg K233911 - VISULAS combi K233911 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Carl Zeiss Meditec, AG. Cleared Sep 2024. https://www.510kdatabase.net/k233921/ 2024-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k233921-luvis-chair-lc700c-fda-510k.jpg K233921 - Luvis Chair (LC700C) K233921 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentis Co., Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k233974/ 2024-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k233974-mucosal-impedance-measurement-system-fda-510k.jpg K233974 - Mucosal Impedance Measurement System K233974 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Alandra Medical Sapi DE CV. Cleared Sep 2024. https://www.510kdatabase.net/k234035/ 2024-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k234035-cosine-spacer-fda-510k.jpg K234035 - COSINE™ Spacer K234035 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k234044/ 2024-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k234044-acs-ld-fb-knee-system-fda-510k.jpg K234044 - ACS® LD FB Knee System K234044 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Implantcast GmbH. Cleared Sep 2024. https://www.510kdatabase.net/k240411/ 2024-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k240411-uai-portal-fda-510k.jpg K240411 - uAI Portal K240411 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Intelligence Co., Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k240600/ 2024-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k240600-safecross-vascular-introducer-system-fda-510k.jpg K240600 - SafeCross Vascular Introducer System (4001) K240600 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: East End Medical I, LLC. Cleared Sep 2024. https://www.510kdatabase.net/k241164/ 2024-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k241164-ib3d-pl-spinal-system-fda-510k.jpg K241164 - IB3D™ PL Spinal System K241164 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medicrea International S.A.S. (Medtronic). Cleared Sep 2024. https://www.510kdatabase.net/k241415/ 2024-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k241415-orchid-safety-release-valve-fda-510k.jpg K241415 - Orchid Safety Release Valve™ K241415 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Linear Health Sciences, LLC. Cleared Sep 2024. https://www.510kdatabase.net/k241427/ 2024-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k241427-access-syphilis-fda-510k.jpg K241427 - Access Syphilis K241427 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k241552/ 2024-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k241552-mentor-memorygel-enhance-single-use-fda-510k.jpg K241552 - MENTOR™ MemoryGel™ Enhance Single Use Gel Sizer K241552 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Mentor Worldwide, LLC. Cleared Sep 2024. https://www.510kdatabase.net/k241579/ 2024-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k241579-dd-hybridlayer-multicolored-zirconia-fda-510k.jpg K241579 - DD Hybridlayer (multicolored zirconia) K241579 is a FDA 510(k) cleared dental medical device. Manufacturer: Dental Direkt GmbH. Cleared Sep 2024. https://www.510kdatabase.net/k241672/ 2024-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k241672-copro-3-fda-510k.jpg K241672 - COPRO 3 K241672 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Amt Engineering Co., Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k241693/ 2024-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k241693-femchec-controlled-saline-air-device-fda-510k.jpg K241693 - FemChec Controlled Saline-Air Device (FCD-250) K241693 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Femasys, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k241976/ 2024-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k241976-nextaro-va-15mm-5m-fda-510k.jpg K241976 - nextaro® va, 15mm, 5µm K241976 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sfm Medical Devices GmbH. Cleared Sep 2024. https://www.510kdatabase.net/k242415/ 2024-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k242415-tmc-compression-implant-system-fda-510k.jpg K242415 - TMC Compression Implant System K242415 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Treace Medical Concepts. Cleared Sep 2024. https://www.510kdatabase.net/k231566/ 2024-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k231566-icx-implant-system-fda-510k.jpg K231566 - ICX-Implant System K231566 is a FDA 510(k) cleared dental medical device. Manufacturer: Medentis Medical GmbH. Cleared Sep 2024. https://www.510kdatabase.net/k231741/ 2024-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k231741-progear-surgical-mask-with-oxafence-fda-510k.jpg K231741 - ProGear® Surgical Mask with Oxafence®, Model AV82030 K231741 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Prestige Ameritech. Cleared Sep 2024. https://www.510kdatabase.net/k232692/ 2024-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k232692-powered-mobility-scooter-models-pms101-fda-510k.jpg K232692 - Powered Mobility Scooter (Models: PMS101, GUT112, PMS103, GUT140) K232692 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Intradin (Shanghai) Machinery Co., Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k233998/ 2024-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k233998-traqinform-iq-fda-510k.jpg K233998 - TRAQinform IQ K233998 is a FDA 510(k) cleared radiology medical device. Manufacturer: Aiq Global, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k240203/ 2024-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k240203-urus-system-dmg-su100urus-fda-510k.jpg K240203 - URUS System (DMG-SU100/URUS) K240203 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Dyne Medical Group, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k241155/ 2024-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k241155-cold-sore-device-qpz-03-fda-510k.jpg K241155 - Cold Sore Device (QPZ-03) K241155 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Nuon Medical Equipment Co., Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k241356/ 2024-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k241356-fine-osteotomy-fda-510k.jpg K241356 - Fine Osteotomy™ K241356 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Bodycad Laboratories, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k241605/ 2024-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k241605-adaptix-peek-interbody-system-with-fda-510k.jpg K241605 - Adaptix™ PEEK Interbody System with Nanotechnology K241605 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nanovis, LLC. Cleared Sep 2024. https://www.510kdatabase.net/k241721/ 2024-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k241721-electric-wheelchair-n3901-fda-510k.jpg K241721 - Electric wheelchair (N3901) K241721 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zhejiang Richall Medical Technology Co., Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k241723/ 2024-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k241723-electric-wheelchair-w3902-fda-510k.jpg K241723 - Electric wheelchair (W3902) K241723 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zhejiang Richall Medical Technology Co., Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k242390/ 2024-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k242390-novum-iq-syringe-pump-40800baxus-fda-510k.jpg K242390 - Novum IQ Syringe Pump (40800BAXUS) K242390 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corporation. Cleared Sep 2024. https://www.510kdatabase.net/k221275/ 2024-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k221275-qraycam-pro-fda-510k.jpg K221275 - Qraycam PRO K221275 is a FDA 510(k) cleared dental medical device. Manufacturer: AIOBIO Co., Ltd.. Cleared Sep 2024. https://www.510kdatabase.net/k231095/ 2024-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k231095-tamper-evident-cap-fda-510k.jpg K231095 - Tamper Evident Cap K231095 is a FDA 510(k) cleared general hospital medical device. Manufacturer: International Medical Industries, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k231502/ 2024-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k231502-mini-screws-fda-510k.jpg K231502 - Mini Screws K231502 is a FDA 510(k) cleared dental medical device. Manufacturer: Proimtech Saglik Urunleri Anonim Sirketi. Cleared Sep 2024. https://www.510kdatabase.net/k233977/ 2024-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k233977-velacur-fda-510k.jpg K233977 - Velacur K233977 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sonic Incytes. Cleared Sep 2024. https://www.510kdatabase.net/k240142/ 2024-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k240142-fujifilm-endoscope-model-eg-840n-fda-510k.jpg K240142 - FUJIFILM Endoscope Model EG-840N K240142 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fujifilm Corporation. Cleared Sep 2024. https://www.510kdatabase.net/k240158/ 2024-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k240158-modular-medical-modd1-insulin-delivery-fda-510k.jpg K240158 - Modular Medical MODD1 Insulin Delivery System K240158 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Modular Medical, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k240646/ 2024-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k240646-dreamclear-fda-510k.jpg K240646 - DreamClear K240646 is a FDA 510(k) cleared neurology medical device. Manufacturer: Somnomed Technologies Inc., Doing Business AS Remware. Cleared Sep 2024. https://www.510kdatabase.net/k241071/ 2024-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k241071-nextdent-jet-denture-base-fda-510k.jpg K241071 - NextDent Jet Denture Base K241071 is a FDA 510(k) cleared dental medical device. Manufacturer: Vertex-Dental B.V.. Cleared Sep 2024. https://www.510kdatabase.net/k242305/ 2024-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k242305-be-plus-pro-neurotravel-light-fda-510k.jpg K242305 - BE Plus PRO, Neurotravel LIGHT K242305 is a FDA 510(k) cleared neurology medical device. Manufacturer: Eb Neuro S.P.A.. Cleared Sep 2024. https://www.510kdatabase.net/k242306/ 2024-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k242306-signalned-system-model-re-fda-510k.jpg K242306 - SignalNED System (Model RE) K242306 is a FDA 510(k) cleared neurology medical device. Manufacturer: Forest Devices, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k233805/ 2024-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k233805-k5-fda-510k.jpg K233805 - K5 K233805 is a FDA 510(k) cleared dental medical device. Manufacturer: Osstem Implant Co., Ltd. Chair Business. Cleared Sep 2024. https://www.510kdatabase.net/k240487/ 2024-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k240487-evos-patella-plates-fda-510k.jpg K240487 - EVOS Patella Plates K240487 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew. Cleared Sep 2024. https://www.510kdatabase.net/k241295/ 2024-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k241295-somatom-onsite-fda-510k.jpg K241295 - SOMATOM On.site K241295 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k241611/ 2024-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k241611-shapeit-si014135-fda-510k.jpg K241611 - ShapeIT (SI014135) K241611 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Imds Operations B.V.. Cleared Sep 2024. https://www.510kdatabase.net/k242069/ 2024-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k242069-eminent-spine-scoliosis-deformity-fda-510k.jpg K242069 - Eminent Spine Scoliosis Deformity Pedicle Screw System K242069 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Eminent Spine. Cleared Sep 2024. https://www.510kdatabase.net/k242251/ 2024-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k242251-litho-60-fda-510k.jpg K242251 - Litho 60 K242251 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Quanta System Spa. Cleared Sep 2024. https://www.510kdatabase.net/k242319/ 2024-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k242319-indigo-aspiration-system-aspiration-fda-510k.jpg K242319 - Indigo® Aspiration System – Aspiration Catheter 6X K242319 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Penumbra, Inc.. Cleared Sep 2024. https://www.510kdatabase.net/k241592/ 2024-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k241592-arthrex-val-and-val-kreulock-fda-510k.jpg K241592 - Arthrex VAL and VAL KreuLock™ Compression Screw System K241592 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k231969/ 2024-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k231969-basen-wearable-breast-pump-model-ym-fda-510k.jpg K231969 - BASEN Wearable Breast Pump (Model: YM-801, YM-803, YM-805, YM-806, YM-808) K231969 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Dongguanshi Yiyingmei Technology Co., Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k232441/ 2024-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k232441-unipro-k-unipro-us-fda-510k.jpg K232441 - Unipro (K-UNIPRO-US) K232441 is a FDA 510(k) cleared neurology medical device. Manufacturer: Tenscare, Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k233107/ 2024-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k233107-alphenix-infx-8000vb-infx-8000vs-v95-fda-510k.jpg K233107 - Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5 K233107 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Aug 2024. https://www.510kdatabase.net/k233872/ 2024-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k233872-daylight-fda-510k.jpg K233872 - Daylight K233872 is a FDA 510(k) cleared neurology medical device. Manufacturer: Big Health, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k233932/ 2024-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k233932-alinity-i-toxo-igm-fda-510k.jpg K233932 - Alinity i Toxo IgM K233932 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Aug 2024. https://www.510kdatabase.net/k234027/ 2024-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k234027-embecta-insulin-delivery-system-fda-510k.jpg K234027 - embecta Insulin Delivery System K234027 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Embecta Medical I, LLC. Cleared Aug 2024. https://www.510kdatabase.net/k240003/ 2024-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k240003-velmeni-for-dentists-v4d-fda-510k.jpg K240003 - Velmeni for Dentists (V4D) K240003 is a FDA 510(k) cleared radiology medical device. Manufacturer: Velmeni, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k240180/ 2024-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k240180-orthopeasia-spinal-fixation-system-fda-510k.jpg K240180 - Orthopeasia Spinal Fixation System K240180 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthopeasia Co., Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k240464/ 2024-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k240464-wallflex-biliary-rx-stent-system-fda-510k.jpg K240464 - WallFlex Biliary RX Stent System K240464 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific. Cleared Aug 2024. https://www.510kdatabase.net/k241051/ 2024-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k241051-vave-wireless-ultrasound-system-fda-510k.jpg K241051 - Vave Wireless Ultrasound System K241051 is a FDA 510(k) cleared radiology medical device. Manufacturer: Vave Health, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k241148/ 2024-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k241148-salto-talaris-ankle-psi-system-fda-510k.jpg K241148 - Salto Talaris Ankle PSI System K241148 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 3D Systems, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k241256/ 2024-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k241256-jetboots-pro-plus-fda-510k.jpg K241256 - JetBoots PRO Plus K241256 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Therabody, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k241318/ 2024-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k241318-nova-surface-applicator-adpt-ondem-fda-510k.jpg K241318 - Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA) K241318 is a FDA 510(k) cleared radiology medical device. Manufacturer: Adaptiiv Medical Technologies, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k241326/ 2024-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k241326-cadence-ankle-psi-system-fda-510k.jpg K241326 - Cadence Ankle PSI System K241326 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 3D Systems, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k241386/ 2024-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k241386-heyman-packing-applicator-set-gm11004580-fda-510k.jpg K241386 - Heyman Packing Applicator Set (GM11004580) K241386 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k241393/ 2024-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k241393-odi-tech-fda-510k.jpg K241393 - ODI-Tech K241393 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Odi Medical AS. Cleared Aug 2024. https://www.510kdatabase.net/k241518/ 2024-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k241518-horizon-30-tms-therapy-system-horizon-fda-510k.jpg K241518 - Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire) K241518 is a FDA 510(k) cleared neurology medical device. Manufacturer: The Magstim Company Limited. Cleared Aug 2024. https://www.510kdatabase.net/k241583/ 2024-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k241583-vascuchek-kit-vascuchek-transceiver-fda-510k.jpg K241583 - VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01) K241583 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Remington Medical, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k241585/ 2024-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k241585-umi-panorama-fda-510k.jpg K241585 - uMI Panorama K241585 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k241602/ 2024-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k241602-kingcera-dental-zirconia-blank-fda-510k.jpg K241602 - Kingcera Dental Zirconia Blank K241602 is a FDA 510(k) cleared dental medical device. Manufacturer: Hunan Qinghao Puzhong Technology Co., Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k241662/ 2024-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k241662-ultrasound-transducer-cover-fda-510k.jpg K241662 - Ultrasound Transducer Cover K241662 is a FDA 510(k) cleared radiology medical device. Manufacturer: Vitrolife Sweden AB. Cleared Aug 2024. https://www.510kdatabase.net/k241823/ 2024-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k241823-toxiseal-vial-adaptor-fda-510k.jpg K241823 - ToxiSeal™ Vial Adaptor K241823 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Epic Medical Pte. , Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k241847/ 2024-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k241847-imbio-pha-400-fda-510k.jpg K241847 - Imbio PHA (4.0.0) K241847 is a FDA 510(k) cleared radiology medical device. Manufacturer: Imbio, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k241957/ 2024-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k241957-talee-talee-postop-fda-510k.jpg K241957 - Talee, Talee PostOp K241957 is a FDA 510(k) cleared neurology medical device. Manufacturer: Invent Medical USA, LLC. Cleared Aug 2024. https://www.510kdatabase.net/k242249/ 2024-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k242249-conformity-stem-extension-line-fda-510k.jpg K242249 - Conformity Stem Extension Line K242249 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: United Orthopedic Corporation. Cleared Aug 2024. https://www.510kdatabase.net/k242275/ 2024-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k242275-syngovia-mi-workflows-fda-510k.jpg K242275 - syngo.via MI Workflows K242275 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k242300/ 2024-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k242300-mi-viewgo-fda-510k.jpg K242300 - MI View&GO K242300 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k220908/ 2024-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k220908-ensol-entm-specimen-collection-and-fda-510k.jpg K220908 - Ensol EnTM Specimen Collection and Transport System K220908 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Ensol Biosciences, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k233826/ 2024-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k233826-kosmos-fda-510k.jpg K233826 - Kosmos K233826 is a FDA 510(k) cleared radiology medical device. Manufacturer: EchoNous, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k240105/ 2024-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k240105-navigator-fmnvg15-fda-510k.jpg K240105 - Navigator (FMNVG15) K240105 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Forcemech International, LLC. Cleared Aug 2024. https://www.510kdatabase.net/k241227/ 2024-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k241227-rhythmia-hdx-mapping-system-fda-510k.jpg K241227 - RHYTHMIA HDx™ Mapping System K241227 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Aug 2024. https://www.510kdatabase.net/k241400/ 2024-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k241400-skinpen-precision-elite-system-fda-510k.jpg K241400 - SkinPen Precision Elite System K241400 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Crown Aesthetics. Cleared Aug 2024. https://www.510kdatabase.net/k241881/ 2024-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k241881-ipl-hair-removal-device-jm-843-jm-865-fda-510k.jpg K241881 - IPL Hair Removal Device (JM-843, JM-865, JM-638) K241881 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Junmei Technology Co., Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k242243/ 2024-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k242243-target-detachable-coils-fda-510k.jpg K242243 - Target Detachable Coils K242243 is a FDA 510(k) cleared neurology medical device. Manufacturer: Stryker Neurovscular. Cleared Aug 2024. https://www.510kdatabase.net/k242280/ 2024-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k242280-vitoss-bimodal-bioactive-bone-graft-fda-510k.jpg K242280 - Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal Bioactive Bone Graft Substitute, Vitoss BBTrauma® Bioactive Bone Graft Substitute,Vitoss® BA2X Bioactive Bone Graft Substitute, Vitoss® Bioactive Bone Graft Substitute Pack,Vitoss® Bioactive Bone Graft Substitute, Vitoss® Foam Bone Graft Substitute, Vitoss® Bone Graft Substitute Filled Canister, Vitoss® Bone Graft Substitute, Vitoss® Bone Graft Substitute - Synthetic Cancellous Chips K242280 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Spine. Cleared Aug 2024. https://www.510kdatabase.net/k242296/ 2024-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k242296-versatap-suture-anchor-adp050-fda-510k.jpg K242296 - VersaTap™ Suture Anchor (ADP050) K242296 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ortho-Design (Pty), Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k242346/ 2024-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k242346-grass-mr-conditionalct-cup-electrodes-fda-510k.jpg K242346 - Grass® MR Conditional/CT Cup Electrodes K242346 is a FDA 510(k) cleared neurology medical device. Manufacturer: Natus Manufacturing Limited. Cleared Aug 2024. https://www.510kdatabase.net/k232991/ 2024-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k232991-bt-1000-fda-510k.jpg K232991 - BT-1000 K232991 is a FDA 510(k) cleared neurology medical device. Manufacturer: Bistos Co., Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k233816/ 2024-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k233816-redemption-charcot-plating-system-fda-510k.jpg K233816 - REDEMPTION Charcot Plating System K233816 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Vilex, LLC. Cleared Aug 2024. https://www.510kdatabase.net/k233827/ 2024-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k233827-oxiwear-fda-510k.jpg K233827 - OxiWear K233827 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Oxiwear, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k240078/ 2024-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k240078-fogarty-thru-lumen-embolectomy-catheter-fda-510k.jpg K240078 - Fogarty Thru-Lumen Embolectomy Catheter K240078 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Aug 2024. https://www.510kdatabase.net/k240545/ 2024-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k240545-genacheck-nitrile-powder-free-fda-510k.jpg K240545 - GenaCheck™ Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS/S/M/L/XL) K240545 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Genabio Diagnostics, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k241457/ 2024-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k241457-vista-bc-putty-fda-510k.jpg K241457 - Vista BC Putty K241457 is a FDA 510(k) cleared dental medical device. Manufacturer: Inter-Med, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k241534/ 2024-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k241534-vitros-immunodiagnostic-products-fda-510k.jpg K241534 - VITROS Immunodiagnostic Products Syphilis Reagent Pack K241534 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Ortho-Clinical Diagnostics. Cleared Aug 2024. https://www.510kdatabase.net/k241557/ 2024-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k241557-cercon-yo-ml-fda-510k.jpg K241557 - Cercon® yo ML K241557 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona. Cleared Aug 2024. https://www.510kdatabase.net/k241913/ 2024-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k241913-da-vinci-handheld-camera-fda-510k.jpg K241913 - da Vinci Handheld Camera K241913 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical Operations, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k241932/ 2024-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k241932-ossiofiber-compression-staple-fda-510k.jpg K241932 - OSSIOfiber® Compression Staple K241932 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OSSIO , Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k241943/ 2024-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k241943-mojo-full-face-non-vented-mask-fda-510k.jpg K241943 - Mojo Full Face Non-Vented Mask K241943 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sleepnet Corporation. Cleared Aug 2024. https://www.510kdatabase.net/k242316/ 2024-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k242316-safety-lancet-fda-510k.jpg K242316 - Safety Lancet K242316 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ningbo Medsun Medical Co., Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/den230067/ 2024-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/den230067-chronos-fda-510k.jpg DEN230067 - Chronos® DEN230067 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Germitec. Cleared Aug 2024. https://www.510kdatabase.net/k233846/ 2024-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k233846-vitrification-solution-set-and-warming-fda-510k.jpg K233846 - Vitrification Solution Set and Warming Solution Set K233846 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ecmpc, LLC. Cleared Aug 2024. https://www.510kdatabase.net/k234151/ 2024-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k234151-isolator-synergy-encapture-ablation-fda-510k.jpg K234151 - Isolator Synergy EnCapture Ablation System (EMH) K234151 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: AtriCure, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k240270/ 2024-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k240270-electric-wheelchair-s7018-fda-510k.jpg K240270 - Electric wheelchair (S7018) K240270 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Guangdong Prestige Technology Company Limited. Cleared Aug 2024. https://www.510kdatabase.net/k241228/ 2024-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k241228-tenswave-fda-510k.jpg K241228 - TENSWave K241228 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zynex Medical Officer. Cleared Aug 2024. https://www.510kdatabase.net/k241241/ 2024-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k241241-z1-cemented-hip-system-fda-510k.jpg K241241 - Z1 Cemented Hip System K241241 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orchard Medical Development, LLC. Cleared Aug 2024. https://www.510kdatabase.net/k241354/ 2024-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k241354-sealer-solvent-fda-510k.jpg K241354 - Sealer Solvent K241354 is a FDA 510(k) cleared dental medical device. Manufacturer: Inter-Med, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k241517/ 2024-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k241517-q-guidance-system-fda-510k.jpg K241517 - Q Guidance System K241517 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Leibinger GmbH & Co KG. Cleared Aug 2024. https://www.510kdatabase.net/k241523/ 2024-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k241523-injetak-adjustable-tip-needle-dis199-fda-510k.jpg K241523 - injeTAK Adjustable Tip Needle (DIS199 K241523 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Laborie Medical Technologies, Corp.. Cleared Aug 2024. https://www.510kdatabase.net/k241684/ 2024-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k241684-overjet-charting-assist-fda-510k.jpg K241684 - Overjet Charting Assist K241684 is a FDA 510(k) cleared radiology medical device. Manufacturer: Overjet, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k241787/ 2024-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k241787-contour-plus-blue-blood-glucose-fda-510k.jpg K241787 - CONTOUR® PLUS BLUE Blood Glucose Monitoring System K241787 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Ascensia Diabetes Care U.S., Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k242212/ 2024-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k242212-disposable-syringe-kit-fda-510k.jpg K242212 - Disposable Syringe (Kit) K242212 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Nemoto Kyorindo Co., Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k242537/ 2024-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k242537-bracepaste-fluoride-sealant-fda-510k.jpg K242537 - BracePaste Fluoride Sealant K242537 is a FDA 510(k) cleared dental medical device. Manufacturer: American Orthodontics Corp.. Cleared Aug 2024. https://www.510kdatabase.net/k240286/ 2024-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k240286-primed-surgical-masks-and-primed-fda-510k.jpg K240286 - PRIMED Surgical Masks and PRIMED Procedure Masks K240286 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Primed Medical Products, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k240982/ 2024-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k240982-dess-dental-smart-solutions-fda-510k.jpg K240982 - DESS Dental Smart Solutions K240982 is a FDA 510(k) cleared dental medical device. Manufacturer: Terrats Medical SL. Cleared Aug 2024. https://www.510kdatabase.net/k241538/ 2024-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k241538-triclip-steerable-guide-catheter-fda-510k.jpg K241538 - TriClip Steerable Guide Catheter K241538 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared Aug 2024. https://www.510kdatabase.net/k241607/ 2024-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k241607-myostrain-60-fda-510k.jpg K241607 - MyoStrain (6.0) K241607 is a FDA 510(k) cleared radiology medical device. Manufacturer: Myocardial Solutions, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k241777/ 2024-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k241777-smartadjust-technology-fda-510k.jpg K241777 - SmartAdjust™ Technology K241777 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Insulet Corporation. Cleared Aug 2024. https://www.510kdatabase.net/k241850/ 2024-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k241850-ulricheasyinject-max-2m-xd-10140-fda-510k.jpg K241850 - ulricheasyINJECT Max 2M (XD 10140) K241850 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ulrich GmbH & Co. KG. Cleared Aug 2024. https://www.510kdatabase.net/k241858/ 2024-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k241858-bars-set-10060-fda-510k.jpg K241858 - BARS Set (100.60) K241858 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ovesco Endoscopy AG. Cleared Aug 2024. https://www.510kdatabase.net/k242044/ 2024-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k242044-fiapc-plus-probes-fda-510k.jpg K242044 - FiAPC plus probes K242044 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Erbe Elektromedizin GmbH. Cleared Aug 2024. https://www.510kdatabase.net/k231100/ 2024-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k231100-proimtech-dental-body-implant-fda-510k.jpg K231100 - Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech Abutment Screw K231100 is a FDA 510(k) cleared dental medical device. Manufacturer: Proimtech Saglik Urunleri Anonim Sirketi. Cleared Aug 2024. https://www.510kdatabase.net/k233358/ 2024-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k233358-scov-2-ag-detect-rapid-test-fda-510k.jpg K233358 - SCoV-2 Ag Detect Rapid Test K233358 is a FDA 510(k) cleared microbiology medical device. Manufacturer: InBios International, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k233801/ 2024-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k233801-nalu-neurostimulation-system-for-fda-510k.jpg K233801 - Nalu Neurostimulation System for Spinal Cord Stimulation K233801 is a FDA 510(k) cleared neurology medical device. Manufacturer: Boston Scientific Neuromodulation. Cleared Aug 2024. https://www.510kdatabase.net/k233829/ 2024-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k233829-nova-micro-pillows-mask-small-a-model-fda-510k.jpg K233829 - Nova Micro Pillows Mask Small A Model (NVP1SA) K233829 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Fisher and Paykel Healthcare Limited. Cleared Aug 2024. https://www.510kdatabase.net/k240318/ 2024-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k240318-sitter-35mm-versatile-system-fda-510k.jpg K240318 - SITTER 3.5mm Versatile System K240318 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Bonebridge AG. Cleared Aug 2024. https://www.510kdatabase.net/k240593/ 2024-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k240593-veegix-eeg-system-fda-510k.jpg K240593 - VEEGix EEG System K240593 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neuroservo, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k240790/ 2024-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k240790-polyisoprene-surgical-gloves-fda-510k.jpg K240790 - Polyisoprene Surgical gloves K240790 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Suzhou Colour-Way New Material Co., Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k240896/ 2024-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k240896-one-nitrile-condom-fda-510k.jpg K240896 - ONE Nitrile Condom K240896 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Global Protection Corp.. Cleared Aug 2024. https://www.510kdatabase.net/k241302/ 2024-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k241302-sonosync-fda-510k.jpg K241302 - SonoSync K241302 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Medison Co., Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k241492/ 2024-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k241492-guided-surgery-kit-cases-fda-510k.jpg K241492 - Guided Surgery Kit Cases K241492 is a FDA 510(k) cleared general hospital medical device. Manufacturer: JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A.. Cleared Aug 2024. https://www.510kdatabase.net/k241780/ 2024-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k241780-cardinal-health-nitrile-exam-gloves-fda-510k.jpg K241780 - Cardinal Health Nitrile Exam Gloves K241780 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cardinal Health200, LLC. Cleared Aug 2024. https://www.510kdatabase.net/k242169/ 2024-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k242169-morph-dna-steerable-introducer-sheath-fda-510k.jpg K242169 - Morph DNA Steerable Introducer Sheath K242169 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biocardia. Cleared Aug 2024. https://www.510kdatabase.net/k242191/ 2024-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k242191-soltive-laser-system-soltive-pro-fda-510k.jpg K242191 - SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) K242191 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Surgical Technologies America. Cleared Aug 2024. https://www.510kdatabase.net/k242202/ 2024-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k242202-lightwalker-laser-system-family-fda-510k.jpg K242202 - LightWalker Laser System Family K242202 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Fotona D.O.O.. Cleared Aug 2024. https://www.510kdatabase.net/k242264/ 2024-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k242264-tmini-miniature-robotic-system-fda-510k.jpg K242264 - TMINI Miniature Robotic System K242264 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: THINK Surgical, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k230071/ 2024-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k230071-femur-reconstruction-interlocking-nail-fda-510k.jpg K230071 - Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail System K230071 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tdm Co., Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k234076/ 2024-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k234076-icare-altius-cw-fda-510k.jpg K234076 - iCare ALTIUS CW K234076 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Centervue S.P.A.. Cleared Aug 2024. https://www.510kdatabase.net/k234128/ 2024-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k234128-phantom-fibula-nail-system-fda-510k.jpg K234128 - Phantom Fibula Nail System K234128 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paragon 28, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k240227/ 2024-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k240227-lina-cystovu-hd-cyv-100-5-fda-510k.jpg K240227 - LiNA CystoVu™ HD (CYV-100-5 K240227 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Lina Medical Aps. Cleared Aug 2024. https://www.510kdatabase.net/k241098/ 2024-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k241098-neuroquant-fda-510k.jpg K241098 - NeuroQuant K241098 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cortechs Labs, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k241109/ 2024-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k241109-single-use-sterile-high-pressure-fda-510k.jpg K241109 - Single-use Sterile High-pressure Angiographic Syringes and Accessories K241109 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen Boon Medical Supply Co., Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k241369/ 2024-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k241369-lijia-night-guard-fda-510k.jpg K241369 - LIJIA Night Guard K241369 is a FDA 510(k) cleared dental medical device. Manufacturer: Lijia, LLC. Cleared Aug 2024. https://www.510kdatabase.net/k241803/ 2024-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k241803-insulclock-v20-pro-fda-510k.jpg K241803 - INSULCLOCK® v2.0 PRO K241803 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Insulcloud S.L.. Cleared Aug 2024. https://www.510kdatabase.net/k241804/ 2024-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k241804-trigen-intertan-10s-nail-system-fda-510k.jpg K241804 - TRIGEN INTERTAN 10S Nail System K241804 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k241979/ 2024-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k241979-pocket-ultrasound-system-c10-c10tx-fda-510k.jpg K241979 - Pocket Ultrasound System (C10, C10TX, C10RL, C10RLpro) K241979 is a FDA 510(k) cleared radiology medical device. Manufacturer: Beijing Konted Medical Technology Co.,Ltd. Cleared Aug 2024. https://www.510kdatabase.net/k242126/ 2024-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k242126-iv-administration-set-fda-510k.jpg K242126 - I.V. Administration Set K242126 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bq Plus Medical Co., Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k242248/ 2024-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k242248-introducer-sheath-kits-fda-510k.jpg K242248 - Introducer Sheath Kits K242248 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Beijing Demax Medical Technology Co.,Ltd. Cleared Aug 2024. https://www.510kdatabase.net/k232415/ 2024-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k232415-nalu-neurostimulation-system-for-fda-510k.jpg K232415 - Nalu Neurostimulation System for Peripheral Nerve Stimulation K232415 is a FDA 510(k) cleared neurology medical device. Manufacturer: Boston Scientific Neuromodulation. Cleared Aug 2024. https://www.510kdatabase.net/k233391/ 2024-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k233391-ccell-in-vivo-fda-510k.jpg K233391 - cCeLL - In vivo K233391 is a FDA 510(k) cleared neurology medical device. Manufacturer: VPIX Medical, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k233566/ 2024-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k233566-montage-xt-settable-resorbable-bone-fda-510k.jpg K233566 - Montage-XT Settable, Resorbable Bone Putty K233566 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthocon, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k240290/ 2024-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k240290-aimify-1x-fda-510k.jpg K240290 - AiMIFY (1.x) K240290 is a FDA 510(k) cleared radiology medical device. Manufacturer: Subtle Medical, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k240298/ 2024-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k240298-foundation-dermal-regeneration-fda-510k.jpg K240298 - Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo K240298 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bionova Medical, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k240314/ 2024-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k240314-mula-k2-a1-fda-510k.jpg K240314 - MULA (K2-A1) K240314 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Guangzhou Ciellulu Photoelectric Technology Co., Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k240859/ 2024-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k240859-glidewire-gt-r-fda-510k.jpg K240859 - Glidewire GT-R K240859 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Corporation. Cleared Aug 2024. https://www.510kdatabase.net/k241061/ 2024-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k241061-versa-negative-pressure-wound-therapy-fda-510k.jpg K241061 - VERSA Negative Pressure Wound Therapy System (VCMPP-100) K241061 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cork Medical. Cleared Aug 2024. https://www.510kdatabase.net/k241080/ 2024-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k241080-kerecis-parvus-50207-fda-510k.jpg K241080 - Kerecis Parvus (50207) K241080 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Kerecis Limited. Cleared Aug 2024. https://www.510kdatabase.net/k241351/ 2024-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k241351-blood-pressure-monitor-tmb-2092-g-fda-510k.jpg K241351 - Blood Pressure Monitor (TMB-2092-G) K241351 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Guangdong Transtek Medical Electronics Co., Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k242066/ 2024-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k242066-isage-rx-fda-510k.jpg K242066 - iSage Rx K242066 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Amalgam Rx, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k242141/ 2024-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k242141-tilink-p-si-joint-fusion-system-fda-510k.jpg K242141 - TiLink-P SI Joint Fusion System K242141 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SurGenTec, LLC. Cleared Aug 2024. https://www.510kdatabase.net/k242142/ 2024-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k242142-fraxel-ftx-laser-system-fda-510k.jpg K242142 - Fraxel® FTX Laser System K242142 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Solta Medical. Cleared Aug 2024. https://www.510kdatabase.net/k231932/ 2024-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k231932-tds-techwin-dental-system-fda-510k.jpg K231932 - TDS (TECHWIN DENTAL SYSTEM) K231932 is a FDA 510(k) cleared dental medical device. Manufacturer: Techwin Co., Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k234114/ 2024-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k234114-cutivatm-topical-skin-adhesive-rm-1700-fda-510k.jpg K234114 - CUTIVA(TM) Topical Skin Adhesive (RM-1700) K234114 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Okapi Medical, LLC Dba Resivant Medical. Cleared Aug 2024. https://www.510kdatabase.net/k240077/ 2024-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k240077-mon-a-therm-general-purpose-fda-510k.jpg K240077 - Mon-a-Therm™ General Purpose Temperature Probe 400TM (90050, 90044) K240077 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Covidien. Cleared Aug 2024. https://www.510kdatabase.net/k240200/ 2024-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k240200-hydros-robotic-system-fda-510k.jpg K240200 - HYDROS Robotic System K240200 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Procept Biorobotics. Cleared Aug 2024. https://www.510kdatabase.net/k241102/ 2024-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k241102-luna-4-plus-fda-510k.jpg K241102 - Luna 4 plus K241102 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Foreo, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k241458/ 2024-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k241458-borvo-evac-system-ergo-fda-510k.jpg K241458 - Borvo EVAC System (Ergo) K241458 is a FDA 510(k) cleared neurology medical device. Manufacturer: Borvo Medical, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k241496/ 2024-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k241496-vantage-galan-3t-mrt-3020-v100-with-fda-510k.jpg K241496 - Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR K241496 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Aug 2024. https://www.510kdatabase.net/k241738/ 2024-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k241738-pyxis-3d-titanium-cervical-cage-system-fda-510k.jpg K241738 - PYXIS 3D Titanium Cervical Cage system K241738 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: GS Medical Co., Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k241848/ 2024-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k241848-medtfine-safety-lancet-fda-510k.jpg K241848 - MedtFine Safety Lancet K241848 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ningbo Caremed Medical Products Co., Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k242134/ 2024-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k242134-clearcap-distal-attachment-fda-510k.jpg K242134 - ClearCap Distal Attachment K242134 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Finemedix Co., Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k242189/ 2024-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k242189-celerity-hp-indicator-tape-pcc077-fda-510k.jpg K242189 - CELERITY HP Indicator Tape (PCC077) K242189 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Steris. Cleared Aug 2024. https://www.510kdatabase.net/k240235/ 2024-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k240235-omnitrans-transport-system-fda-510k.jpg K240235 - OmniTrans Transport System K240235 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Shenzhen Dakewe Bio-Engineering Co., Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k241023/ 2024-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k241023-negative-pressure-wound-therapy-device-fda-510k.jpg K241023 - Negative Pressure Wound Therapy Device (V-Move, V-Grand) K241023 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Med Way, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k241275/ 2024-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k241275-histolog-scanner-hardware-24-software-33-fda-510k.jpg K241275 - Histolog® Scanner (Hardware 2.4, Software 3.3) K241275 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Samantree Medical SA. Cleared Aug 2024. https://www.510kdatabase.net/k241282/ 2024-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k241282-ribfix-titan-fixation-system-fda-510k.jpg K241282 - RibFix Titan™ Fixation System K241282 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Riverpoint Medical. Cleared Aug 2024. https://www.510kdatabase.net/k241440/ 2024-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k241440-healthccsng-fda-510k.jpg K241440 - HealthCCSng K241440 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nano-X AI , Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k241504/ 2024-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k241504-ifuse-torq-tnt-implant-system-fda-510k.jpg K241504 - iFuse TORQ TNT™ Implant System K241504 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SI-BONE, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k241870/ 2024-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k241870-onpoint-augmented-reality-spine-system-fda-510k.jpg K241870 - OnPoint Augmented Reality Spine System K241870 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Onpoint Surgical, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k242432/ 2024-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k242432-mt-bone-fda-510k.jpg K242432 - MT-Bone K242432 is a FDA 510(k) cleared dental medical device. Manufacturer: Mectron S.P.A.. Cleared Aug 2024. https://www.510kdatabase.net/k240234/ 2024-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k240234-btl-899ms-fda-510k.jpg K240234 - BTL-899MS K240234 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: BTL Industries, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k222126/ 2024-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k222126-vivachek-fad-blood-glucose-monitoring-fda-510k.jpg K222126 - VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose Monitoring System, VivaChek™ Fad Sync Blood Glucose Monitoring System K222126 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Vivachek Biotech (Hangzhou) Co., Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k223700/ 2024-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k223700-boss-fda-510k.jpg K223700 - BOSS™ K223700 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Intelon Optics, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k231979/ 2024-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k231979-mecun-spo2-sensor-fda-510k.jpg K231979 - Mecun SpO2 sensor K231979 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Mecun Medical Supply Co., Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k233499/ 2024-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k233499-sapphire-nc-ultra-coronary-dilatation-fda-510k.jpg K233499 - Sapphire NC ULTRA Coronary Dilatation Catheter K233499 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: OrbusNeich Medical (Shenzhen) Co., Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k233700/ 2024-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k233700-avicenna-roboflex-fda-510k.jpg K233700 - Avicenna Roboflex K233700 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Elmed Elektronik VE Medikal Sanayi VE Ticaret Anonim Sirketi. Cleared Aug 2024. https://www.510kdatabase.net/k233755/ 2024-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k233755-heartkey-rhythm-fda-510k.jpg K233755 - HeartKey® Rhythm K233755 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: B-Secur Limited. Cleared Aug 2024. https://www.510kdatabase.net/k233896/ 2024-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k233896-jdentalcare-dental-implant-system-fda-510k.jpg K233896 - JDentalCare Dental Implant System: JDEvolution K233896 is a FDA 510(k) cleared dental medical device. Manufacturer: Jdentalcare Srl. Cleared Aug 2024. https://www.510kdatabase.net/k240081/ 2024-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k240081-human-lubricant-fda-510k.jpg K240081 - Human Lubricant K240081 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Jiangxi Wulinxiang Biological Technology Co., Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k240133/ 2024-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k240133-xenograft-bovine-bone-particulate-fda-510k.jpg K240133 - Xenograft Bovine Bone Particulate K240133 is a FDA 510(k) cleared dental medical device. Manufacturer: Collagen Solutions, LLC. Cleared Aug 2024. https://www.510kdatabase.net/k240307/ 2024-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k240307-vitavitro-embryo-transfer-catheter-fda-510k.jpg K240307 - VitaVitro Embryo Transfer Catheter (Models ET-S, ET-SI, ET-A, ET-I, ET-IH) K240307 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shenzhen Vitavitro Biotech Co., Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k240573/ 2024-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k240573-itero-lumina-pro-fda-510k.jpg K240573 - iTero Lumina™ Pro K240573 is a FDA 510(k) cleared dental medical device. Manufacturer: Align Technology , Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k240740/ 2024-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k240740-qct-ln-quant-fda-510k.jpg K240740 - qCT LN Quant K240740 is a FDA 510(k) cleared radiology medical device. Manufacturer: Qure.Ai Technologies. Cleared Aug 2024. https://www.510kdatabase.net/k240978/ 2024-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k240978-seleneview-single-use-digital-fda-510k.jpg K240978 - SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G) K240978 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: MacroLux Medical Technology Co., Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k241236/ 2024-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k241236-xtra-collection-sets-fda-510k.jpg K241236 - XTRA Collection sets K241236 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sorin Group Italia S.R.L.. Cleared Aug 2024. https://www.510kdatabase.net/k241314/ 2024-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k241314-kls-martin-oral-max-implants-mr-fda-510k.jpg K241314 - KLS Martin Oral-Max Implants MR Conditional (bundled) K241314 is a FDA 510(k) cleared dental medical device. Manufacturer: KLS-Martin L.P.. Cleared Aug 2024. https://www.510kdatabase.net/k242108/ 2024-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k242108-ambu-ascope-5-uretero-standard-fda-510k.jpg K242108 - Ambu® aScope™ 5 Uretero (Standard Deflection) K242108 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ambu A/S. Cleared Aug 2024. https://www.510kdatabase.net/k242127/ 2024-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k242127-acl-top-family-50-series-acl-top-750-fda-510k.jpg K242127 - ACL TOP Family 50 Series (ACL TOP 750 K242127 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory (IL) Co.. Cleared Aug 2024. https://www.510kdatabase.net/k242239/ 2024-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k242239-hf-oct-imaging-system-with-vis-rx-fda-510k.jpg K242239 - HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter)) K242239 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Gentuity, LLC. Cleared Aug 2024. https://www.510kdatabase.net/den230090/ 2024-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/den230090-first-to-know-syphilis-test-fda-510k.jpg DEN230090 - First To Know Syphilis Test DEN230090 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Nowdiagnostics. Cleared Aug 2024. https://www.510kdatabase.net/k233505/ 2024-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k233505-sapphire-ultra-coronary-dilatation-fda-510k.jpg K233505 - Sapphire ULTRA Coronary Dilatation Catheter K233505 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: OrbusNeich Medical (Shenzhen) Co., Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k233965/ 2024-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k233965-ultradrape-ugpiv-barrier-and-fda-510k.jpg K233965 - UltraDrape UGPIV Barrier and Securement (34-15) K233965 is a FDA 510(k) cleared radiology medical device. Manufacturer: Parker Laboratories, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k240837/ 2024-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k240837-tov-dental-implant-system-fda-510k.jpg K240837 - TOV Dental Implant System K240837 is a FDA 510(k) cleared dental medical device. Manufacturer: Rdj Tov Implant, Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k240961/ 2024-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k240961-disposable-pen-injector-assembly-fda-510k.jpg K240961 - Disposable Pen Injector Assembly K240961 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wuxi Nest Biotechnology Co., Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k241211/ 2024-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k241211-columbo-fda-510k.jpg K241211 - CoLumbo K241211 is a FDA 510(k) cleared radiology medical device. Manufacturer: Smart Soft Healthcare. Cleared Aug 2024. https://www.510kdatabase.net/k241401/ 2024-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k241401-connected-or-hub-with-device-and-voice-fda-510k.jpg K241401 - Connected OR Hub with Device and Voice Control K241401 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker Endoscopy. Cleared Aug 2024. https://www.510kdatabase.net/k241522/ 2024-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k241522-npseal-20-and-25-fda-510k.jpg K241522 - NPseal (20 and 25) K241522 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Guard Medical, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k241596/ 2024-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k241596-umi-panvivo-fda-510k.jpg K241596 - uMI Panvivo K241596 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k241750/ 2024-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k241750-medifun-safety-lancet-msl1-series-fda-510k.jpg K241750 - Medifun Safety Lancet ( MSL1 series) K241750 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medifun Corporation. Cleared Aug 2024. https://www.510kdatabase.net/k241754/ 2024-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k241754-ncb-polyaxial-locking-plate-system-fda-510k.jpg K241754 - NCB® Polyaxial Locking Plate System K241754 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer Switzerland Manufacturing GmbH. Cleared Aug 2024. https://www.510kdatabase.net/k241810/ 2024-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k241810-microletnext-lancet-fda-510k.jpg K241810 - MICROLET®NEXT Lancet K241810 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ascensia Diabetes Care U.S., Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k242061/ 2024-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k242061-reusable-interface-cable-15-m-prd-ifc-fda-510k.jpg K242061 - Reusable Interface Cable 1.5 m (PRD-IFC-002) K242061 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Creo Medical, Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k232836/ 2024-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k232836-family-of-dimar-dmax-niv-masks-fda-510k.jpg K232836 - Family of DIMAR DMAX NIV masks K232836 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Dimar S.P.A.. Cleared Aug 2024. https://www.510kdatabase.net/k240595/ 2024-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k240595-utepreva-endometrial-sampler-up01-fda-510k.jpg K240595 - Utepreva Endometrial Sampler (UP01) K240595 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Utepreva, LLC. Cleared Aug 2024. https://www.510kdatabase.net/k240713/ 2024-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k240713-traumagel-fda-510k.jpg K240713 - TRAUMAGEL® K240713 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cresilon, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k240957/ 2024-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k240957-catapult-guide-sheath-fda-510k.jpg K240957 - Catapult Guide Sheath K240957 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Contract Medical International, GmbH. Cleared Aug 2024. https://www.510kdatabase.net/k241510/ 2024-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k241510-crosslead-tracker-fda-510k.jpg K241510 - CROSSLEAD Tracker K241510 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Asahi Intecc Co., Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k241571/ 2024-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k241571-bostonsight-specialty-lenses-fda-510k.jpg K241571 - BostonSight® Specialty Lenses K241571 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Boston Foundation For Sight, Inc. D/B/A Bostonsight. Cleared Aug 2024. https://www.510kdatabase.net/k241748/ 2024-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k241748-intimate-rose-vaginal-dilators-fda-510k.jpg K241748 - Intimate Rose Vaginal Dilators K241748 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Plus EV Holdings Dba Intimate Rose. Cleared Aug 2024. https://www.510kdatabase.net/k241969/ 2024-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k241969-hightop-home-use-fentanylnorfentanyl-fda-510k.jpg K241969 - Hightop® Home Use Fentanyl/Norfentanyl Urine Rapid Test Panel K241969 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Qingdao Hightop Biotech Co., Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k242057/ 2024-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k242057-coolief-radiofrequency-generator-crg-fda-510k.jpg K242057 - COOLIEF* Radiofrequency Generator (CRG-BASIC, CRG-BASIC-R, CRG-ADVANCED, CRG-ADVANCED-R) K242057 is a FDA 510(k) cleared neurology medical device. Manufacturer: Avanos Medical, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k242059/ 2024-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k242059-flexlens-silicone-hydrogel-daily-wear-fda-510k.jpg K242059 - Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A) K242059 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: X-Cel Specialty Contacts, A Walman Optical Company. Cleared Aug 2024. https://www.510kdatabase.net/k242077/ 2024-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k242077-pocguidetm-multi-drug-test-cup-otc-fda-510k.jpg K242077 - PocguideTM Multi-Drug Test Cup OTC, PocguideTM Multi-Drug Test Cup K242077 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Aicheck Biotech, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k240807/ 2024-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k240807-vm-2000-fda-510k.jpg K240807 - VM-2000 K240807 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Ventis Medical, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k241094/ 2024-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k241094-bullsai-fda-510k.jpg K241094 - Bullsai K241094 is a FDA 510(k) cleared radiology medical device. Manufacturer: Turing Medical Technologies, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k241387/ 2024-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k241387-colink-neofuse-mis-plating-system-see-fda-510k.jpg K241387 - CoLink NeoFuse MIS Plating System (see attached parts list) K241387 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: In2bones USA. Cleared Aug 2024. https://www.510kdatabase.net/k241429/ 2024-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k241429-echelon-synergy-mri-system-fda-510k.jpg K241429 - ECHELON Synergy MRI System K241429 is a FDA 510(k) cleared radiology medical device. Manufacturer: Fujifilm Healthcare Corporation. Cleared Aug 2024. https://www.510kdatabase.net/k241547/ 2024-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k241547-diode-laser-therapy-device-df-diode-fda-510k.jpg K241547 - Diode Laser Therapy Device (DF-DIODE LASER-S1) K241547 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Weifang Dragonfly Electronics Technology Co., Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k241686/ 2024-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k241686-power-wheelchair-n6101-fda-510k.jpg K241686 - Power wheelchair (N6101) K241686 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zhejiang Zhonglei Medical Technology Co. , Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k241699/ 2024-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k241699-super-veloce-fda-510k.jpg K241699 - SUPER VELOCE K241699 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ilooda Co,., Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k241813/ 2024-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k241813-si-technology-si-desis-x-sacroiliac-fda-510k.jpg K241813 - SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System K241813 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Si-Technology, LLC. Cleared Aug 2024. https://www.510kdatabase.net/k241978/ 2024-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k241978-shinetell-digital-pregnancy-test-fda-510k.jpg K241978 - Shinetell Digital Pregnancy Test K241978 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Hangzhou AllTest Biotech Co., Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k233367/ 2024-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k233367-idart-lyme-igg-immunoblot-kit-fda-510k.jpg K233367 - iDart Lyme IgG ImmunoBlot Kit K233367 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Id-Fish Technology, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k240868/ 2024-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k240868-ultravision2-ionpencil-fda-510k.jpg K240868 - Ultravision2™ IonPencil K240868 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Alesi Surgical Limited. Cleared Aug 2024. https://www.510kdatabase.net/k241328/ 2024-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k241328-aprevo-anterior-and-lateral-lumbar-fda-510k.jpg K241328 - aprevo® Anterior and Lateral Lumbar Interbody Fusion device (ALIF/LLIF) K241328 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Carlsmed, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k241365/ 2024-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k241365-pixie-pulse-sm9068-fda-510k.jpg K241365 - Pixie Pulse (SM9068) K241365 is a FDA 510(k) cleared neurology medical device. Manufacturer: Pixie Cup, LLC. Cleared Aug 2024. https://www.510kdatabase.net/k241402/ 2024-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k241402-medical-monitor-32hr734s-fda-510k.jpg K241402 - Medical Monitor (32HR734S) K241402 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lg Electronics.Inc. Cleared Aug 2024. https://www.510kdatabase.net/k241656/ 2024-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k241656-eneka-selectif-fda-510k.jpg K241656 - Eneka Selectif K241656 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Termosalud. Cleared Aug 2024. https://www.510kdatabase.net/k241846/ 2024-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k241846-e3d-c-interbody-system-fda-510k.jpg K241846 - E3D™-C Interbody System K241846 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Evolution Spine. Cleared Aug 2024. https://www.510kdatabase.net/k242054/ 2024-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k242054-optimmri-v2-fda-510k.jpg K242054 - OptimMRI (v2) K242054 is a FDA 510(k) cleared radiology medical device. Manufacturer: Rebrain, Sas. Cleared Aug 2024. https://www.510kdatabase.net/k242096/ 2024-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k242096-ds-footankle-coil-8ch-15t-fda-510k.jpg K242096 - dS FootAnkle Coil 8ch 1.5T K242096 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Aug 2024. https://www.510kdatabase.net/den210037/ 2024-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/den210037-soclean-3-bacterial-reduction-device-fda-510k.jpg DEN210037 - SoClean 3+ Bacterial Reduction Device DEN210037 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Soclean, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k222688/ 2024-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k222688-the-trust-fda-510k.jpg K222688 - The Trust K222688 is a FDA 510(k) cleared dental medical device. Manufacturer: Genoss Co., Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k231950/ 2024-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k231950-medidiode-fda-510k.jpg K231950 - MEDIDIODE K231950 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medicreations, LLC. Cleared Aug 2024. https://www.510kdatabase.net/k232404/ 2024-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k232404-cholesterol-fda-510k.jpg K232404 - CHOLESTEROL K232404 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Medicon Hellas S.A. Cleared Aug 2024. https://www.510kdatabase.net/k233643/ 2024-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k233643-fp-airvo-3-niv-pt311us-fda-510k.jpg K233643 - F&P Airvo 3 NIV (PT311US) K233643 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Fisher &Paykel Healthcare , Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k233697/ 2024-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k233697-sonomax-series-digital-color-doppler-fda-510k.jpg K233697 - SonoMax Series Digital Color Doppler Ultrasound System K233697 is a FDA 510(k) cleared radiology medical device. Manufacturer: CHISON Medical Technologies Co., Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k234053/ 2024-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k234053-fp-optiflow-flow-diverter-fda-510k.jpg K234053 - F&P Optiflow Flow Diverter K234053 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Fisher &Paykel Healthcare , Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k240079/ 2024-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k240079-electric-wheelchair-panda-10-fda-510k.jpg K240079 - Electric Wheelchair (Panda 10) K240079 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Suzhou Ideal Medical Co., Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k240469/ 2024-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k240469-access-tpo-antibody-fda-510k.jpg K240469 - Access TPO Antibody K240469 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k240664/ 2024-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k240664-alara-bma-neuro-access-kit-alara-bman-fda-510k.jpg K240664 - ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) K240664 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: SurGenTec, LLC. Cleared Aug 2024. https://www.510kdatabase.net/k241376/ 2024-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k241376-hypersuture-all-blue-extension-line-fda-510k.jpg K241376 - HyperSuture All Blue Extension Line K241376 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Threadstone, LLC. Cleared Aug 2024. https://www.510kdatabase.net/k242016/ 2024-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k242016-ensite-x-ep-system-fda-510k.jpg K242016 - EnSite™ X EP System K242016 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared Aug 2024. https://www.510kdatabase.net/k231775/ 2024-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k231775-gr-resin-system-msi-fda-510k.jpg K231775 - GR Resin System MSI K231775 is a FDA 510(k) cleared dental medical device. Manufacturer: Pro3Dure Medical. Cleared Aug 2024. https://www.510kdatabase.net/k233312/ 2024-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k233312-soloassist-iid-dexter-endoscope-arm-fda-510k.jpg K233312 - SOLOASSIST IID / DEXTER ENDOSCOPE ARM (212499) K233312 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aktormed GmbH. Cleared Aug 2024. https://www.510kdatabase.net/k233315/ 2024-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k233315-hipxpert-and-hipinsight-system-fda-510k.jpg K233315 - HipXpert and HipInsight System K233315 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Surgical Planning Associates, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k233356/ 2024-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k233356-illusion-aligner-pro-illusion-aligner-fda-510k.jpg K233356 - Illusion Aligner Pro: Illusion Aligner FLX K233356 is a FDA 510(k) cleared dental medical device. Manufacturer: Laxmi Dental Export Pvt., Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k233702/ 2024-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k233702-smarxt-tubing-and-connectors-fda-510k.jpg K233702 - SMARxT Tubing and Connectors K233702 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: LivaNova USA, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k233720/ 2024-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k233720-luminopia-fda-510k.jpg K233720 - Luminopia K233720 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Luminopia, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k233822/ 2024-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k233822-i2contour-fda-510k.jpg K233822 - i2Contour K233822 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mrimath, LLC. Cleared Aug 2024. https://www.510kdatabase.net/k233844/ 2024-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k233844-odneclean-fda-510k.jpg K233844 - OdneClean K233844 is a FDA 510(k) cleared dental medical device. Manufacturer: Odne AG. Cleared Aug 2024. https://www.510kdatabase.net/k234058/ 2024-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k234058-fp-optiflow-filtered-nasal-interface-fda-510k.jpg K234058 - F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J) K234058 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Fisher &Paykel Healthcare , Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k240229/ 2024-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k240229-masimo-w1-fda-510k.jpg K240229 - Masimo W1 K240229 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Masimo Corporation. Cleared Aug 2024. https://www.510kdatabase.net/k240724/ 2024-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k240724-synthvision-100-fda-510k.jpg K240724 - SynthVISION 1.0.0 K240724 is a FDA 510(k) cleared radiology medical device. Manufacturer: Synthesis Health Intelligence, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k241665/ 2024-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k241665-omni-legend-fda-510k.jpg K241665 - Omni Legend K241665 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems Israel, Functional Imaging. Cleared Aug 2024. https://www.510kdatabase.net/k242009/ 2024-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k242009-360cas-knee-fda-510k.jpg K242009 - 360CAS Knee K242009 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Kico Knee Innovation Company Pty, Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k212969/ 2024-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k212969-liposaver-fda-510k.jpg K212969 - Liposaver K212969 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lhbiomed Co., Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k233433/ 2024-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k233433-sphere-9dx-diagnostic-catheter-afr-00009-fda-510k.jpg K233433 - Sphere-9Dx Diagnostic Catheter (AFR-00009) K233433 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic. Cleared Aug 2024. https://www.510kdatabase.net/k233605/ 2024-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k233605-advia-centaur-ebv-ebna-igg-fda-510k.jpg K233605 - ADVIA Centaur EBV-EBNA IgG K233605 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Biokit, S.A.. Cleared Aug 2024. https://www.510kdatabase.net/k233606/ 2024-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k233606-advia-centaur-ebv-vca-igm-fda-510k.jpg K233606 - ADVIA Centaur EBV-VCA IgM K233606 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Biokit, S.A.. Cleared Aug 2024. https://www.510kdatabase.net/k240255/ 2024-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k240255-electric-wheelchair-jle-w01a-2023-fda-510k.jpg K240255 - Electric Wheelchair (JLE-W01A-2023) K240255 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zhejiang Jianrui Technology Company Limited. Cleared Aug 2024. https://www.510kdatabase.net/k240330/ 2024-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k240330-halyard-smart-fold-sterilization-wrap-fda-510k.jpg K240330 - HALYARD* SMART-FOLD* Sterilization Wrap (H450) K240330 is a FDA 510(k) cleared general hospital medical device. Manufacturer: O&M Halyard, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k240605/ 2024-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k240605-ultra-rapidwarm-blast-fda-510k.jpg K240605 - Ultra RapidWarm™ Blast K240605 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Vitrolife Sweden AB. Cleared Aug 2024. https://www.510kdatabase.net/k241530/ 2024-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k241530-stellar-imaging-system-fda-510k.jpg K241530 - Stellar Imaging System K241530 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Guangdong Optomedic Technologies, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k241644/ 2024-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k241644-spineart-navigation-instrument-system-fda-510k.jpg K241644 - SPINEART Navigation Instrument System K241644 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spineart SA. Cleared Aug 2024. https://www.510kdatabase.net/k241685/ 2024-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k241685-sofwave-system-fda-510k.jpg K241685 - SofWave System K241685 is a FDA 510(k) cleared neurology medical device. Manufacturer: Sofwave Medical, Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k233920/ 2024-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k233920-eosedge-fda-510k.jpg K233920 - EOSedge K233920 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eos Imaging. Cleared Aug 2024. https://www.510kdatabase.net/k240796/ 2024-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k240796-myablation-guide-vb80a-fda-510k.jpg K240796 - myAblation Guide (VB80A) K240796 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Healthcare GmbH. Cleared Aug 2024. https://www.510kdatabase.net/k241528/ 2024-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k241528-nitrile-powder-free-examination-gloves-fda-510k.jpg K241528 - Nitrile Powder Free Examination Gloves (Blue), Non-Sterile Low Dermatitis Potential K241528 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Comfort Rubber Gloves Industries Sdn. Bhd.. Cleared Aug 2024. https://www.510kdatabase.net/k241708/ 2024-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k241708-abiomed-14fr-low-profile-introducer-kit-fda-510k.jpg K241708 - Abiomed 14Fr Low Profile Introducer Kit K241708 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abiomed, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k233577/ 2024-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k233577-sleepio-fda-510k.jpg K233577 - Sleepio® K233577 is a FDA 510(k) cleared neurology medical device. Manufacturer: Big Health, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k233653/ 2024-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k233653-midfield-light-pipe-23ga-3269m06-00-fda-510k.jpg K233653 - Midfield Light Pipe, 23ga (3269.M06-00) K233653 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Peregrine Surgical, LLC. Cleared Aug 2024. https://www.510kdatabase.net/k233761/ 2024-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k233761-orthopaedic-surgery-planning-software-fda-510k.jpg K233761 - Orthopaedic Surgery Planning Software (AIJOINT) K233761 is a FDA 510(k) cleared radiology medical device. Manufacturer: Longwood Valley Medical , Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k233992/ 2024-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k233992-precision-ai-surgical-planning-system-fda-510k.jpg K233992 - Precision AI Surgical Planning System (PAI-SPS) K233992 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Precision AI Pty, Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k240127/ 2024-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k240127-plumesafe-x5-smoke-management-system-fda-510k.jpg K240127 - PlumeSafe X5 Smoke Management System K240127 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Conmed Corporation. Cleared Aug 2024. https://www.510kdatabase.net/k240782/ 2024-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k240782-cellfx-percutaneous-electrode-system-fda-510k.jpg K240782 - CellFX Percutaneous Electrode System (SYS3000) K240782 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Pulse Biosciences, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k240932/ 2024-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k240932-hybridtherm-system-fda-510k.jpg K240932 - HybridTherm System K240932 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Erbe Elektromedizin GmbH. Cleared Aug 2024. https://www.510kdatabase.net/k240953/ 2024-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k240953-ai-platform-20-aip002-fda-510k.jpg K240953 - AI Platform 2.0 (AIP002) K240953 is a FDA 510(k) cleared radiology medical device. Manufacturer: Exo Imaging. Cleared Aug 2024. https://www.510kdatabase.net/k241360/ 2024-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k241360-universal-seal-5-12-mm-fda-510k.jpg K241360 - Universal Seal (5-12 mm) K241360 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k241635/ 2024-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k241635-da-vinci-e-200-electrosurgical-generator-fda-510k.jpg K241635 - da Vinci E-200 Electrosurgical Generator K241635 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical. Cleared Aug 2024. https://www.510kdatabase.net/k233098/ 2024-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k233098-myotouch-muscle-stimulator-fda-510k.jpg K233098 - MYOTouch Muscle Stimulator K233098 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Sunmed, LLC. Cleared Aug 2024. https://www.510kdatabase.net/k233534/ 2024-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k233534-viral-transport-medium-fda-510k.jpg K233534 - Viral Transport Medium K233534 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Hardy Diagnostics. Cleared Aug 2024. https://www.510kdatabase.net/k233571/ 2024-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k233571-gci-surgical-gown-fda-510k.jpg K233571 - GCI Surgical Gown K233571 is a FDA 510(k) cleared general hospital medical device. Manufacturer: George Courey, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k233601/ 2024-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k233601-fixone-meniscal-repair-fda-510k.jpg K233601 - Fixone Meniscal Repair K233601 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aju Pharm Co., Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k233706/ 2024-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k233706-bendini-cloud-application-fda-510k.jpg K233706 - Bendini Cloud Application K233706 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nuvasive. Cleared Aug 2024. https://www.510kdatabase.net/k233798/ 2024-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k233798-moda-flx-hemodialysis-system-and-fda-510k.jpg K233798 - Moda-flx Hemodialysis System and Cartridge K233798 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Diality, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k233984/ 2024-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k233984-acumen-assisted-fluid-management-afm-fda-510k.jpg K233984 - Acumen Assisted Fluid Management (AFM) Software Feature K233984 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Aug 2024. https://www.510kdatabase.net/k240909/ 2024-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k240909-samsung-ecg-app-v-13-ecg-fda-510k.jpg K240909 - Samsung ECG App v 1.3 (ECG) K240909 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Samsung Electronics Co., Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k240981/ 2024-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k240981-air-compression-leg-massager-fda-510k.jpg K240981 - Air compression leg massager K240981 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Huizhou Xinyi Technology Co., Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k241181/ 2024-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k241181-disposable-ureteral-guide-sheath-fda-510k.jpg K241181 - Disposable Ureteral Guide Sheath K241181 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Dongguan Zsr Biomedical Technology Company Limited. Cleared Aug 2024. https://www.510kdatabase.net/k241268/ 2024-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k241268-thermalite-heated-cpap-tube-fda-510k.jpg K241268 - Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS) K241268 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Exceleron Medical. Cleared Aug 2024. https://www.510kdatabase.net/k241311/ 2024-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k241311-thermoforming-sheet-materials-track-a-fda-510k.jpg K241311 - Thermoforming Sheet Materials (Track A) K241311 is a FDA 510(k) cleared dental medical device. Manufacturer: Bernhard F?rster GmbH. Cleared Aug 2024. https://www.510kdatabase.net/k241359/ 2024-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k241359-medline-unite-mis-foot-recon-screw-fda-510k.jpg K241359 - Medline UNITE® MIS Foot Recon Screw System K241359 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medline Industries, LP. Cleared Aug 2024. https://www.510kdatabase.net/k241564/ 2024-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k241564-actifuse-abx-fda-510k.jpg K241564 - Actifuse ABX K241564 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Baxter Healthcare Corporation. Cleared Aug 2024. https://www.510kdatabase.net/k241621/ 2024-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k241621-da-vinci-monopolar-and-bipolar-fda-510k.jpg K241621 - Da Vinci Monopolar and Bipolar Adapters (378896) K241621 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical. Cleared Aug 2024. https://www.510kdatabase.net/k241642/ 2024-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k241642-diode-laser-hair-removal-system-mbt-fda-510k.jpg K241642 - Diode Laser Hair Removal System (MBT-Diode Laser) K241642 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Beijing Mega Beauty Technology Co., Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k241716/ 2024-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k241716-global-modular-replacement-system-fda-510k.jpg K241716 - Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee Component K241716 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp., Dba Stryker Orthopaedics. Cleared Aug 2024. https://www.510kdatabase.net/k241892/ 2024-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k241892-cortera-spinal-fixation-system-fda-510k.jpg K241892 - Cortera™ Spinal Fixation System K241892 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Xtant Medical Holdings, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k241918/ 2024-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k241918-mentor-cpx4-plus-enhance-breast-tissue-fda-510k.jpg K241918 - MENTOR™ CPX™4 PLUS Enhance Breast Tissue Expander K241918 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Mentor Worldwide, LLC. Cleared Aug 2024. https://www.510kdatabase.net/k241919/ 2024-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k241919-innovita-hcg-pregnancy-rapid-combo-test-fda-510k.jpg K241919 - Innovita HCG Pregnancy Rapid Combo Test K241919 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Innovita (Tangshan) Biological Technology Co., Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k241970/ 2024-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k241970-powder-free-nitrile-examination-gloves-fda-510k.jpg K241970 - Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS,S,M,L,XL,XXL) K241970 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Kanglongda Vietnam Protection Technology Company Limited. Cleared Aug 2024. https://www.510kdatabase.net/k241987/ 2024-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k241987-single-use-video-hysteroscope-rp-g-c24-fda-510k.jpg K241987 - Single-Use Video Hysteroscope (RP-G-C24, RP-G-C0101) K241987 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Guangzhou Red Pine Medical Instrument Co., Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k242008/ 2024-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k242008-coronis-onelook-fda-510k.jpg K242008 - Coronis OneLook K242008 is a FDA 510(k) cleared radiology medical device. Manufacturer: Barco N.V.. Cleared Aug 2024. https://www.510kdatabase.net/k232469/ 2024-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k232469-rsch-latex-gold-foley-catheter-fda-510k.jpg K232469 - Rüsch Latex Gold Foley Catheter K232469 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Teleflexmedical, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k233580/ 2024-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k233580-a-breathing-system-abs-fda-510k.jpg K233580 - A Breathing System (ABS) K233580 is a FDA 510(k) cleared neurology medical device. Manufacturer: Deepwell Dtx, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k233696/ 2024-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k233696-depuy-synthes-retrograde-femoral-nail-fda-510k.jpg K233696 - DePuy Synthes Retrograde Femoral Nail Advanced System K233696 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Synthes. Cleared Aug 2024. https://www.510kdatabase.net/k233731/ 2024-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k233731-cardiq-suite-fda-510k.jpg K233731 - CardIQ Suite K233731 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems SCS. Cleared Aug 2024. https://www.510kdatabase.net/k233793/ 2024-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k233793-carboclear-x-pedicle-screw-system-fda-510k.jpg K233793 - CarboClear® X Pedicle Screw System K233793 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: CarboFix Orthopedics , Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k233942/ 2024-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k233942-pentax-medical-video-duodenoscope-ed34-fda-510k.jpg K233942 - PENTAX Medical Video Duodenoscope (ED34-i10T2s) K233942 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Pentax of America, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k234141/ 2024-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k234141-aisap-cardio-v10-fda-510k.jpg K234141 - AISAP Cardio V1.0 K234141 is a FDA 510(k) cleared radiology medical device. Manufacturer: Aisap. Cleared Aug 2024. https://www.510kdatabase.net/k240035/ 2024-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k240035-tactix-vector-syndesmosis-system-fda-510k.jpg K240035 - TACTIX Vector Syndesmosis System K240035 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Vilex, LLC. Cleared Aug 2024. https://www.510kdatabase.net/k240301/ 2024-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k240301-mammoscreen-3-fda-510k.jpg K240301 - MammoScreen® (3) K240301 is a FDA 510(k) cleared radiology medical device. Manufacturer: Therapixel. Cleared Aug 2024. https://www.510kdatabase.net/k240312/ 2024-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k240312-infinity-centralstation-wide-fda-510k.jpg K240312 - Infinity CentralStation Wide K240312 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Draeger Medical Systems, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k240805/ 2024-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k240805-flyte-mechanotherapy-system-mti-15-mti-fda-510k.jpg K240805 - Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5) K240805 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Pelvital USA, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k241105/ 2024-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k241105-3mp-color-lcd-monitor-cl-s301-fda-510k.jpg K241105 - 3MP Color LCD Monitor (CL-S301) K241105 is a FDA 510(k) cleared radiology medical device. Manufacturer: Jvckenwood Corporation. Cleared Aug 2024. https://www.510kdatabase.net/k241137/ 2024-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k241137-clear-moves-aligner-fda-510k.jpg K241137 - Clear Moves Aligner K241137 is a FDA 510(k) cleared dental medical device. Manufacturer: Clear Moves Aligners. Cleared Aug 2024. https://www.510kdatabase.net/k241140/ 2024-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k241140-virozap-indoor-air-purifier-in-duct-fda-510k.jpg K241140 - ViroZap Indoor Air Purifier, In Duct Model 1008 K241140 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Applied Photonix, LLC. Cleared Aug 2024. https://www.510kdatabase.net/k241145/ 2024-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k241145-tlab-transvenous-liver-biopsy-system-fda-510k.jpg K241145 - TLAB® Transvenous Liver Biopsy System (TF-18C) K241145 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Argon Medical Devices, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k241238/ 2024-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k241238-loop-led-curing-light-system-clk01-fda-510k.jpg K241238 - LOOP™ LED Curing Light System (CLK01) K241238 is a FDA 510(k) cleared dental medical device. Manufacturer: Garrison Dental Solutions, LLC. Cleared Aug 2024. https://www.510kdatabase.net/k241690/ 2024-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k241690-logical-liner-fda-510k.jpg K241690 - Logical Liner K241690 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Signature Orthopaedics Pty, Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k241945/ 2024-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k241945-karl-storz-ped-cysto-urethro-fda-510k.jpg K241945 - KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278AC2) K241945 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Karl Storz SE & CO. KG. Cleared Aug 2024. https://www.510kdatabase.net/k242046/ 2024-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k242046-exult-knee-replacement-system-fda-510k.jpg K242046 - EXULT Knee Replacement System K242046 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corentec Co., Ltd.. Cleared Aug 2024. https://www.510kdatabase.net/k242055/ 2024-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k242055-freefix-forearm-plating-system-fda-510k.jpg K242055 - Freefix Forearm Plating System K242055 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Skeletal Dynamics, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/den230046/ 2024-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/den230046-pgdx-elio-plasma-focus-dx-fda-510k.jpg DEN230046 - PGDx elio plasma focus Dx DEN230046 is a FDA 510(k) cleared pathology medical device. Manufacturer: Personal Genome Diagnostics, Inc.. Cleared Aug 2024. https://www.510kdatabase.net/k233541/ 2024-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k233541-architect-active-b12-holotranscobalamin-fda-510k.jpg K233541 - ARCHITECT Active-B12 (Holotranscobalamin) K233541 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Axis-Shield Diagnostics, Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k233555/ 2024-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k233555-af531-oro-nasal-ee-leak-1-face-mask-fda-510k.jpg K233555 - AF531 Oro-Nasal EE Leak 1 Face Mask K233555 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Philips Respironics. Cleared Jul 2024. https://www.510kdatabase.net/k233808/ 2024-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k233808-lw-narrow-implant-system-fda-510k.jpg K233808 - LW Narrow Implant System K233808 is a FDA 510(k) cleared dental medical device. Manufacturer: Ossvis Co., Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k240578/ 2024-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k240578-venatech-lp-vena-cava-filter-system-fda-510k.jpg K240578 - VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter System K240578 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k240898/ 2024-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k240898-steritite-rigid-reusable-sterilization-fda-510k.jpg K240898 - SteriTite rigid reusable sterilization container with MediTray Products K240898 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Case Medical. Cleared Jul 2024. https://www.510kdatabase.net/k240967/ 2024-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k240967-valvulopro-valvuloplasty-balloon-fda-510k.jpg K240967 - ValvuloPro Valvuloplasty Balloon Catheter K240967 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Dongguan TT Medical, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k241225/ 2024-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k241225-silverlon-wound-contact-burn-contact-fda-510k.jpg K241225 - Silverlon® Wound Contact, Burn Contact Dressing K241225 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Argentum Medical, LLC. Cleared Jul 2024. https://www.510kdatabase.net/k241917/ 2024-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k241917-earp-nerve-cuff-electrode-fda-510k.jpg K241917 - EARP Nerve Cuff Electrode K241917 is a FDA 510(k) cleared neurology medical device. Manufacturer: Retropsoas Technologies, LLC. Cleared Jul 2024. https://www.510kdatabase.net/k241934/ 2024-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k241934-navicam-xpress-stomach-capsule-fda-510k.jpg K241934 - NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule/Tether (NaviCam Xpress Stomach System with NaviCam Capsule/Tether) K241934 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Anx Robotica Corp. Cleared Jul 2024. https://www.510kdatabase.net/k240280/ 2024-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k240280-nano-check-rsv-test-fda-510k.jpg K240280 - Nano-Check™ RSV Test K240280 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Nano-Ditech Corporation. Cleared Jul 2024. https://www.510kdatabase.net/k240446/ 2024-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k240446-calx-o-calcium-hydroxide-powder-fda-510k.jpg K240446 - Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax + K240446 is a FDA 510(k) cleared dental medical device. Manufacturer: Shiva Products. Cleared Jul 2024. https://www.510kdatabase.net/k240531/ 2024-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k240531-smartshape-healing-abutment-fda-510k.jpg K240531 - SmartShape™ Healing Abutment K240531 is a FDA 510(k) cleared dental medical device. Manufacturer: BioHorizons Implant Systems, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k241539/ 2024-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k241539-activmotion-s-fda-510k.jpg K241539 - Activmotion S K241539 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Newclip Technics. Cleared Jul 2024. https://www.510kdatabase.net/k241963/ 2024-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k241963-weray-fda-510k.jpg K241963 - WERAY K241963 is a FDA 510(k) cleared radiology medical device. Manufacturer: Picopack Co., Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k233723/ 2024-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k233723-medical-surgical-mask-fda-510k.jpg K233723 - Medical surgical mask K233723 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guangdong Kingfa Sci. & Tech.Co., Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k234125/ 2024-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k234125-atriclip-flex-mini-laa-exclusion-fda-510k.jpg K234125 - AtriClip FLEX-Mini LAA Exclusion System (ACHM) K234125 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: AtriCure, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k240326/ 2024-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k240326-solar-lumbar-interbody-fusion-system-fda-510k.jpg K240326 - Solar™ Lumbar Interbody Fusion System K240326 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Degen Medical, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k240359/ 2024-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k240359-powerglide-pro-midline-catheter-fda-510k.jpg K240359 - PowerGlide Pro™ Midline Catheter K240359 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson and Company (Bard Access Systems, Inc.). Cleared Jul 2024. https://www.510kdatabase.net/k241209/ 2024-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k241209-echotip-acucore-eus-biopsy-needle-echo-fda-510k.jpg K241209 - EchoTip AcuCore™ EUS Biopsy Needle (ECHO-BX-19) K241209 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Ireland, Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k241464/ 2024-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k241464-arx-sai-implant-system-fda-510k.jpg K241464 - ARx® SAI Implant System K241464 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k241906/ 2024-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k241906-biobrace-reinforced-implant-fda-510k.jpg K241906 - BioBrace® Reinforced Implant K241906 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Conmed Corporation. Cleared Jul 2024. https://www.510kdatabase.net/k241912/ 2024-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k241912-biocharge-fda-510k.jpg K241912 - BIOCHARGE K241912 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nanofiber Solutions, LLC. Cleared Jul 2024. https://www.510kdatabase.net/k242050/ 2024-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k242050-montage-settable-bone-putty-fda-510k.jpg K242050 - Montage Settable Bone Putty K242050 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthocon, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k220328/ 2024-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k220328-easystat-300-fda-510k.jpg K220328 - EasyStat 300 K220328 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Medica Corporation. Cleared Jul 2024. https://www.510kdatabase.net/k231776/ 2024-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k231776-cell-free-dna-bct-fda-510k.jpg K231776 - Cell-Free DNA BCT K231776 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Streck, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k233287/ 2024-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k233287-vent-vial-adapter-fda-510k.jpg K233287 - Vent Vial Adapter K233287 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hangzhou Qiantang Longyue Biotechnology Co., Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k233501/ 2024-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k233501-largan-health-ai-tech-sleep-apnea-and-fda-510k.jpg K233501 - “LARGAN Health AI-Tech” Sleep Apnea and Sleep Quality Examination System (ST-SLP03A) K233501 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Largan Medical Co., Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k233530/ 2024-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k233530-exsys-dexi-exsys-dexi-d401s-frm-fda-510k.jpg K233530 - EXSYS DEXi (EXSYS DEXi-D401S-FRM) K233530 is a FDA 510(k) cleared radiology medical device. Manufacturer: DRTECH Corporation. Cleared Jul 2024. https://www.510kdatabase.net/k233725/ 2024-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k233725-spine-navigation-system-fda-510k.jpg K233725 - Spine Navigation System K233725 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medivis, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k233994/ 2024-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k233994-volt-proximal-humerus-35-plating-system-fda-510k.jpg K233994 - VOLT™ Proximal Humerus 3.5 Plating System K233994 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes GmbH. Cleared Jul 2024. https://www.510kdatabase.net/k234131/ 2024-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k234131-resolv-endoscopic-hemostat-system-fda-510k.jpg K234131 - Resolv Endoscopic Hemostat System K234131 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Hemostasis, LLC. Cleared Jul 2024. https://www.510kdatabase.net/k240169/ 2024-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k240169-stellaris-elite-vision-enhancement-fda-510k.jpg K240169 - Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455) K240169 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Bausch and Lomb, Incorporated. Cleared Jul 2024. https://www.510kdatabase.net/k240246/ 2024-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k240246-accusafe-transseptal-guidewire-fda-510k.jpg K240246 - Accusafe Transseptal Guidewire (GTR31180, GTR31230) K240246 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Synaptic Medical Corporation. Cleared Jul 2024. https://www.510kdatabase.net/k240401/ 2024-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k240401-clearvision-single-use-hysteroscope-fda-510k.jpg K240401 - ClearVision Single Use Hysteroscope & Image Processing System (EHS-Dx4001, EHS-Op5001, EHS-Op6001, EHS-IPS01US) K240401 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Origyn Medical Technology (Hangzhou) Co., Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k240509/ 2024-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k240509-star-apollo-mapping-system-fda-510k.jpg K240509 - STAR Apollo™ Mapping System K240509 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Rhythm AI, Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k241028/ 2024-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k241028-luja-female-20051-fda-510k.jpg K241028 - Luja female (20051) K241028 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Coloplast. Cleared Jul 2024. https://www.510kdatabase.net/k241078/ 2024-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k241078-tandem-mobi-insulin-pump-with-fda-510k.jpg K241078 - Tandem Mobi Insulin Pump with interoperable technology K241078 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Tandem Diabetes Care, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k241187/ 2024-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k241187-alien-aligners-fda-510k.jpg K241187 - Alien Aligners K241187 is a FDA 510(k) cleared dental medical device. Manufacturer: Alien Milling Technologies. Cleared Jul 2024. https://www.510kdatabase.net/k241494/ 2024-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k241494-pantheon-pedicle-screw-and-iliac-bolt-fda-510k.jpg K241494 - Pantheon Pedicle Screw and Iliac Bolt Fixation System K241494 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Pantheon Spinal. Cleared Jul 2024. https://www.510kdatabase.net/k241515/ 2024-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k241515-nexa-npwt-system-fda-510k.jpg K241515 - NEXA™ NPWT System K241515 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Nexa Medical Limited. Cleared Jul 2024. https://www.510kdatabase.net/k241800/ 2024-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k241800-atellica-ch-hdl-cholesterol-hdlc-fda-510k.jpg K241800 - Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC) K241800 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k241845/ 2024-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k241845-introcan-safety-2-iv-catheter-fda-510k.jpg K241845 - Introcan Safety® 2 IV Catheter K241845 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k241866/ 2024-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k241866-innovamatrixfd-fda-510k.jpg K241866 - InnovaMatrix®FD K241866 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Convatec Triad Life Sciences, LLC. Cleared Jul 2024. https://www.510kdatabase.net/k241883/ 2024-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k241883-doro-sterile-disposable-skull-pins-fda-510k.jpg K241883 - DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00) K241883 is a FDA 510(k) cleared neurology medical device. Manufacturer: Pro-Med Instruments GmbH. Cleared Jul 2024. https://www.510kdatabase.net/k241898/ 2024-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k241898-symbia-spect-and-spectct-systems-fda-510k.jpg K241898 - Symbia SPECT and SPECT/CT Systems K241898 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Healthineers. Cleared Jul 2024. https://www.510kdatabase.net/k233372/ 2024-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k233372-karl-storz-fiber-telescopes-for-urology-fda-510k.jpg K233372 - KARL STORZ Fiber Telescopes for Urology K233372 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Karl Storz SE & CO. KG. Cleared Jul 2024. https://www.510kdatabase.net/k233563/ 2024-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k233563-navident-fda-510k.jpg K233563 - Navident K233563 is a FDA 510(k) cleared dental medical device. Manufacturer: Claronav, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k240886/ 2024-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k240886-fluent-pro-fluid-management-system-flt-fda-510k.jpg K240886 - Fluent Pro Fluid Management System (FLT-200) K240886 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Hologic, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k241063/ 2024-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k241063-s-clean-scanhealing-abutment-fda-510k.jpg K241063 - s-Clean ScanHealing Abutment K241063 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentis Co., Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k241165/ 2024-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k241165-atellica-im-high-sensitivity-troponin-fda-510k.jpg K241165 - Atellica® IM High-Sensitivity Troponin I (TnIH) K241165 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k241171/ 2024-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k241171-spine-guidance-software-version-51-fda-510k.jpg K241171 - Spine Guidance Software (Version 5.1) K241171 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Leibinger GmbH & Co KG. Cleared Jul 2024. https://www.510kdatabase.net/k241203/ 2024-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k241203-pmd-clean-redvolution-4005-moab-na-fda-510k.jpg K241203 - PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT, 4005-cream-NA, 4005-cream-INT, 4005-twilight-NA , 4005-twilight-INT, 4005-grey-NA, 4005-grey- INT) K241203 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Dongguan Hunter Electronic Technology Co., Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k241361/ 2024-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k241361-arthrex-synergy-vision-endoscopic-fda-510k.jpg K241361 - Arthrex Synergy Vision Endoscopic Imaging System K241361 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Arthrex, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k241864/ 2024-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k241864-grappler-interference-screw-system-fda-510k.jpg K241864 - Grappler Interference Screw System K241864 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paragon 28, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k241887/ 2024-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k241887-gi-genius-module-100-ggm100us-fda-510k.jpg K241887 - GI Genius™ Module 100 (GGM100.US) K241887 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cosmo Artificial Intelligence - Ai, Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k230305/ 2024-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k230305-the-graft-collagen-fda-510k.jpg K230305 - THE Graft Collagen K230305 is a FDA 510(k) cleared dental medical device. Manufacturer: Purgo Biologics, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k231251/ 2024-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k231251-flexwing-anterior-cervical-plate-system-fda-510k.jpg K231251 - FlexWing Anterior Cervical Plate System K231251 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Jeil Medical Corporation. Cleared Jul 2024. https://www.510kdatabase.net/k233352/ 2024-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k233352-aptima-hcv-quant-dx-assay-fda-510k.jpg K233352 - Aptima HCV Quant Dx Assay K233352 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Hologic, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k233865/ 2024-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k233865-x-smart-pro-fda-510k.jpg K233865 - X-Smart Pro K233865 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k240044/ 2024-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k240044-caddie-fda-510k.jpg K240044 - CADDIE K240044 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Odin Medical Limited. Cleared Jul 2024. https://www.510kdatabase.net/k240431/ 2024-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k240431-exactrac-dynamic-20-fda-510k.jpg K240431 - ExacTrac Dynamic (2.0) K240431 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab AG. Cleared Jul 2024. https://www.510kdatabase.net/k240457/ 2024-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k240457-c2-cryoballoon-ablation-system-c2-fda-510k.jpg K240457 - C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System) K240457 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Pentax of America, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k240714/ 2024-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k240714-insure-universal-fda-510k.jpg K240714 - Insure® Universal K240714 is a FDA 510(k) cleared dental medical device. Manufacturer: Cosmedent, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k240780/ 2024-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k240780-inmode-rf-system-fda-510k.jpg K240780 - InMode RF System K240780 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Inmode , Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k241130/ 2024-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k241130-point-kinguide-agile-hybrid-navigation-fda-510k.jpg K241130 - “POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000) K241130 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Point Robotics MedTech, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k241150/ 2024-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k241150-misti-silicone-implant-fda-510k.jpg K241150 - MISTI Silicone Implant K241150 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Keosan Trading Co.. Cleared Jul 2024. https://www.510kdatabase.net/k241243/ 2024-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k241243-intra-operative-positioning-system-fda-510k.jpg K241243 - Intra-Operative Positioning System (IOPS®) Viewpoint (Simple Curve Catheters) K241243 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Centerline Biomedical, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k241502/ 2024-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k241502-p-scope-fda-510k.jpg K241502 - P-SCOPE K241502 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Oui Medical, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k241789/ 2024-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k241789-non-sterile-ultrasound-transmission-gels-fda-510k.jpg K241789 - Non-Sterile Ultrasound Transmission Gels K241789 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hony Medical Co., Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k241863/ 2024-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k241863-erisma-lp-spinal-fixation-system-fda-510k.jpg K241863 - Erisma® Lp Spinal Fixation System K241863 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Clariance. Cleared Jul 2024. https://www.510kdatabase.net/k240756/ 2024-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k240756-aitrics-vc-fda-510k.jpg K240756 - AITRICS-VC K240756 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Aitrics Co., Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k240906/ 2024-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k240906-te-air-diagnostic-ultrasound-system-fda-510k.jpg K240906 - TE Air Diagnostic Ultrasound System K240906 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k241114/ 2024-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k241114-ezdent-i-e2-prora-view-smart-m-viewer-fda-510k.jpg K241114 - EzDent-i / E2 / Prora View / Smart M Viewer (v3.5) K241114 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ewoosoft Co., Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k241296/ 2024-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k241296-gaudi-proximal-humerus-plate-fda-510k.jpg K241296 - Gaudi Proximal Humerus Plate K241296 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Netbiologics, LLC. Cleared Jul 2024. https://www.510kdatabase.net/k231133/ 2024-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k231133-neo315-fda-510k.jpg K231133 - neo315 K231133 is a FDA 510(k) cleared radiology medical device. Manufacturer: Neoscan Solution GmbH. Cleared Jul 2024. https://www.510kdatabase.net/k234091/ 2024-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k234091-maverick-diagnostic-system-tc1000-fda-510k.jpg K234091 - Maverick Diagnostic System TC1000 K234091 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Genalyte, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k240339/ 2024-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k240339-electric-wheelchair-robooter-e60-bbr-fda-510k.jpg K240339 - Electric Wheelchair (Robooter E60) (BBR-E60-01) K240339 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Shanghai Bangbang Robotics Co., Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k240558/ 2024-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k240558-navoycds-fda-510k.jpg K240558 - NAVOYCDS K240558 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Algodx AB. Cleared Jul 2024. https://www.510kdatabase.net/k240704/ 2024-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k240704-acuson-sequoia-diagnostic-ultrasound-fda-510k.jpg K240704 - ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System, ACUSON Origin ICE Diagnostic Ultrasound System K240704 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k241116/ 2024-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k241116-onycho-laser-v-fda-510k.jpg K241116 - Onycho Laser V K241116 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Terasysd&C, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k241119/ 2024-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k241119-transcutaneous-electrical-nerve-fda-510k.jpg K241119 - Transcutaneous Electrical Nerve Stimulator (K6106) K241119 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Yicai Health Technology Co., Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k241445/ 2024-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k241445-k-bond-universal-fda-510k.jpg K241445 - K-Bond Universal K241445 is a FDA 510(k) cleared dental medical device. Manufacturer: Spident Co., Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k241482/ 2024-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k241482-kinos-total-ankle-system-fda-510k.jpg K241482 - Kinos Total Ankle System K241482 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Restor3d. Cleared Jul 2024. https://www.510kdatabase.net/k240347/ 2024-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k240347-ptg-05-fda-510k.jpg K240347 - PTG-05 K240347 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zimmer Medizinsysteme GmbH. Cleared Jul 2024. https://www.510kdatabase.net/k233067/ 2024-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k233067-wireless-tens-ems-model-fda-510k.jpg K233067 - Wireless TENS & EMS (Model SM9110,SM9113,SM9116) K233067 is a FDA 510(k) cleared neurology medical device. Manufacturer: Chongqing Rob Linka Science and Technology Co., Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k233866/ 2024-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k233866-senhance-surgical-system-fda-510k.jpg K233866 - Senhance Surgical System K233866 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Asensus Surgical, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k233976/ 2024-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k233976-vasoguard-v10-v8-v6-v4-v2-fda-510k.jpg K233976 - VasoGuard (V10, V8, V6, V4, V2) K233976 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Corvascular Diagnostics, LLC. Cleared Jul 2024. https://www.510kdatabase.net/k233979/ 2024-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k233979-vacuette-quickshield-complete-plus-fda-510k.jpg K233979 - VACUETTE® QUICKSHIELD Complete (Plus) K233979 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Greiner Bio-One North America, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k240480/ 2024-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k240480-intelliblate-microwave-ablation-system-fda-510k.jpg K240480 - IntelliBlate Microwave Ablation System Console (IB-CON) K240480 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k240538/ 2024-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k240538-premium-teeth-resin-fda-510k.jpg K240538 - Premium Teeth Resin K240538 is a FDA 510(k) cleared dental medical device. Manufacturer: Formlabs Ohio, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k240835/ 2024-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k240835-suture-button-repair-system-fda-510k.jpg K240835 - Suture Button Repair System K240835 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Skeletal Dynamics, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k241809/ 2024-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k241809-coactiv-antimicrobial-wound-gel-fda-510k.jpg K241809 - coactiv+™ Antimicrobial Wound Gel K241809 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Kane Biotech, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k212521/ 2024-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k212521-field-shield-wound-dressing-fda-510k.jpg K212521 - Field Shield Wound Dressing K212521 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Kericure, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k221495/ 2024-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k221495-solid-clip-single-use-clip-applier-fda-510k.jpg K221495 - SOLID CLIP™ Single Use Clip Applier K221495 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medscope Biotech Co., Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k233482/ 2024-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k233482-equinoxe-central-screw-baseplate-system-fda-510k.jpg K233482 - Equinoxe® Central Screw Baseplate System K233482 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k233768/ 2024-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k233768-papacarie-duo-fda-510k.jpg K233768 - Papacarie Duo K233768 is a FDA 510(k) cleared dental medical device. Manufacturer: Elevate Oral Care. Cleared Jul 2024. https://www.510kdatabase.net/k233917/ 2024-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k233917-ichor-7f-embolectomy-system-ich-7f-fda-510k.jpg K233917 - ICHOR 7F Embolectomy System (ICH-7F) K233917 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ichor. Cleared Jul 2024. https://www.510kdatabase.net/k234029/ 2024-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k234029-cefaly-connected-otc-cefaly-connected-rx-fda-510k.jpg K234029 - CEFALY Connected - OTC, CEFALY Connected - Rx K234029 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cefaly Technology. Cleared Jul 2024. https://www.510kdatabase.net/k240340/ 2024-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k240340-surgical-drive-system-model-es70-es90-e8-fda-510k.jpg K240340 - Surgical Drive System (Model: ES70, ES90, E8) K240340 is a FDA 510(k) cleared dental medical device. Manufacturer: Guangdong Jinme Medical Technology Co., Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k240821/ 2024-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k240821-b4c-system-addition-of-new-sensor-fda-510k.jpg K240821 - B4C System - Addition of new sensor model (BcSs-PICNIW-2000) K240821 is a FDA 510(k) cleared neurology medical device. Manufacturer: Braincare Desenvolvimento E Inova??o Tecnol?gica S.A.. Cleared Jul 2024. https://www.510kdatabase.net/k241060/ 2024-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k241060-hardydisk-ast-cefiderocol-30g-fdc30-fda-510k.jpg K241060 - HardyDisk AST Cefiderocol 30µg (FDC30) K241060 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Hardy Diagnostics. Cleared Jul 2024. https://www.510kdatabase.net/k241206/ 2024-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k241206-quantum-perfusion-hybrid-system-fda-510k.jpg K241206 - Quantum Perfusion Hybrid System K241206 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Spectrum Medical S.R.L.. Cleared Jul 2024. https://www.510kdatabase.net/k241240/ 2024-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k241240-panther-fusion-sars-cov-2flu-abrsv-assay-fda-510k.jpg K241240 - Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay K241240 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Hologic, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k241321/ 2024-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k241321-juliet-ti-ll-lumbar-interbody-device-fda-510k.jpg K241321 - Juliet® Ti LL Lumbar Interbody Device K241321 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spineart SA. Cleared Jul 2024. https://www.510kdatabase.net/k241463/ 2024-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k241463-electric-wheelchair-mp201c-fda-510k.jpg K241463 - Electric Wheelchair (MP201C) K241463 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Suzhou Master Machinery Manufacturing Co.,Ltd. Cleared Jul 2024. https://www.510kdatabase.net/k241879/ 2024-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k241879-vrad-viewer-fda-510k.jpg K241879 - vRad Viewer K241879 is a FDA 510(k) cleared radiology medical device. Manufacturer: Virtual Radiologic Corporation. Cleared Jul 2024. https://www.510kdatabase.net/k233904/ 2024-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k233904-acist-rxi-system-016616-fda-510k.jpg K233904 - ACIST RXi System (016616) K233904 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Acist Medical Systems, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k240503/ 2024-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k240503-sonata-transcervical-fibroid-ablation-fda-510k.jpg K240503 - Sonata Transcervical Fibroid Ablation System 2.2 K240503 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Gynesonics, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k240609/ 2024-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k240609-sin-dental-implant-system-fda-510k.jpg K240609 - S.I.N. Dental Implant System K240609 is a FDA 510(k) cleared dental medical device. Manufacturer: S.I.N. ? Sistema DE Implante Nacional S.A.. Cleared Jul 2024. https://www.510kdatabase.net/k240705/ 2024-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k240705-vitrea-software-package-vstp-002a-v20-fda-510k.jpg K240705 - Vitrea Software Package, VSTP-002A V2.0 K240705 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Jul 2024. https://www.510kdatabase.net/k240845/ 2024-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k240845-rayvolve-fda-510k.jpg K240845 - Rayvolve K240845 is a FDA 510(k) cleared radiology medical device. Manufacturer: Azmed Sas. Cleared Jul 2024. https://www.510kdatabase.net/k241081/ 2024-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k241081-3d-optical-coherence-tomography-3d-oct-fda-510k.jpg K241081 - 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2) K241081 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Topcon Corporation. Cleared Jul 2024. https://www.510kdatabase.net/k241121/ 2024-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k241121-micsi-rmt-fda-510k.jpg K241121 - MICSI-RMT K241121 is a FDA 510(k) cleared radiology medical device. Manufacturer: Microstructure Imaging, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k241413/ 2024-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k241413-sagalign-lumbar-cage-system-various-pns-fda-510k.jpg K241413 - sagAlign Lumbar Cage System (Various PNs) K241413 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Acuity Surgical Devices, LLC. Cleared Jul 2024. https://www.510kdatabase.net/k241467/ 2024-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k241467-stable-c-interbody-system-fda-510k.jpg K241467 - Stable-C Interbody System K241467 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nexus Spine, LLC. Cleared Jul 2024. https://www.510kdatabase.net/k233778/ 2024-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k233778-single-use-suction-access-ureteroscope-fda-510k.jpg K233778 - Single Use Suction Access Ureteroscope (PU400A, PU411A), Single Use Flexible Video Ureteroscope (PU3033H, PU3033AH) K233778 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Zhuhai Pusen Medical Technology Co., Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k240272/ 2024-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k240272-electric-scooter-m2085-s2091-fda-510k.jpg K240272 - Electric Scooter (M2085, S2091) K240272 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Guangdong Prestige Technology Co., Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k240944/ 2024-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k240944-swoop-portable-mr-imaging-system-fda-510k.jpg K240944 - Swoop® Portable MR Imaging® System K240944 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hyperfine, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k241050/ 2024-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k241050-crossroads-modular-tray-system-fda-510k.jpg K241050 - CrossRoads Modular Tray System K241050 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Crossroads Extremity Systems. Cleared Jul 2024. https://www.510kdatabase.net/k241056/ 2024-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k241056-light-cure-adhesive-fda-510k.jpg K241056 - Light Cure Adhesive K241056 is a FDA 510(k) cleared dental medical device. Manufacturer: Sincera Technology (Changchun) Co., Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k241441/ 2024-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k241441-radiforce-rx670-fda-510k.jpg K241441 - RadiForce RX670 K241441 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eizo Corporation. Cleared Jul 2024. https://www.510kdatabase.net/k241740/ 2024-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k241740-finesse-injectable-pta-balloon-fda-510k.jpg K241740 - Finesse Injectable™ PTA Balloon Dilatation Catheter K241740 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Summa Therapeutics. Cleared Jul 2024. https://www.510kdatabase.net/k241741/ 2024-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k241741-safelife-fentanyl-urine-home-test-fda-510k.jpg K241741 - SAFElife™ Fentanyl Urine Home Test (Cassette) K241741 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/den230061/ 2024-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/den230061-allay-nerve-cap-fda-510k.jpg DEN230061 - allay Nerve Cap DEN230061 is a FDA 510(k) cleared neurology medical device. Manufacturer: Tulavi Therapeutics. Cleared Jul 2024. https://www.510kdatabase.net/k233449/ 2024-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k233449-avantik-vtm-fda-510k.jpg K233449 - Avantik VTM K233449 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Hanchang Medic Co., Ltd. (Han Chang Medic). Cleared Jul 2024. https://www.510kdatabase.net/k233458/ 2024-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k233458-cm005-standard-cm005-fda-510k.jpg K233458 - CM005 Standard (CM005) K233458 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Connexicon Medical , Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k233460/ 2024-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k233460-cm00622-linc-skin-closure-system-fda-510k.jpg K233460 - CM00622 LINC Skin Closure System (CM00622 LINC) K233460 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Connexicon Medical , Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k240178/ 2024-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k240178-rfg-01-fda-510k.jpg K240178 - RFG-01 K240178 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Zimmer Medizinsysteme GmbH. Cleared Jul 2024. https://www.510kdatabase.net/k240285/ 2024-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k240285-huxley-sansa-home-sleep-apnea-test-fda-510k.jpg K240285 - Huxley SANSA Home Sleep Apnea Test (1000-00) K240285 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Huxley Medical. Cleared Jul 2024. https://www.510kdatabase.net/k240616/ 2024-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k240616-faq-102-fda-510k.jpg K240616 - FAQ™ (102) K240616 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Foreo, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k241032/ 2024-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k241032-bellatek-bars-fda-510k.jpg K241032 - BellaTek Bars K241032 is a FDA 510(k) cleared dental medical device. Manufacturer: Biomet 3i, LLC. Cleared Jul 2024. https://www.510kdatabase.net/k241739/ 2024-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k241739-endoscopic-applicator-41-cm-fda-510k.jpg K241739 - Endoscopic Applicator, 41 cm K241739 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Micromedics, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k241751/ 2024-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k241751-neurolf-basic-fda-510k.jpg K241751 - NeuroLF (Basic) K241751 is a FDA 510(k) cleared radiology medical device. Manufacturer: Positrigo AG. Cleared Jul 2024. https://www.510kdatabase.net/den230092/ 2024-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/den230092-simplexa-c-auris-direct-simplexa-c-fda-510k.jpg DEN230092 - Simplexa C. auris Direct, Simplexa C. auris Positive Control Pack, Simplexa C. auris Sample Prep Kit (MOL3950, MOL3960, MOL5390) DEN230092 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Diasorin Molecular, LLC. Cleared Jul 2024. https://www.510kdatabase.net/k241385/ 2024-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k241385-omnifix-syringe-nrfit-fda-510k.jpg K241385 - Omnifix Syringe NRFit K241385 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k232372/ 2024-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k232372-peters-surgical-advantime-absorbable-fda-510k.jpg K232372 - Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) K232372 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Peters Surgical. Cleared Jul 2024. https://www.510kdatabase.net/k233457/ 2024-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k233457-rus-fda-510k.jpg K233457 - RUS K233457 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hutom, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k233557/ 2024-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k233557-hemocare-hemodialysis-system-fda-510k.jpg K233557 - HemoCare Hemodialysis System K233557 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Deka Research and Development. Cleared Jul 2024. https://www.510kdatabase.net/k233644/ 2024-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k233644-megadyne-patient-return-electrode-pad-fda-510k.jpg K233644 - Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient Return Electrode Pad - Universal Plus (model 0847), Megadyne Patient Return Electrode Pad - Universal Dual Plus (model 0848) K233644 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Megadyne Medical Products, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k233834/ 2024-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k233834-infinity-gateway-suite-fda-510k.jpg K233834 - Infinity Gateway Suite K233834 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Draeger Medical Systems, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k234009/ 2024-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k234009-acorn-3d-software-ac-seg-4009-fda-510k.jpg K234009 - Acorn 3D Software (AC-SEG-4009) K234009 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mighty Oak Medical. Cleared Jul 2024. https://www.510kdatabase.net/k234077/ 2024-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k234077-spira-anterior-lumbar-spacers-fda-510k.jpg K234077 - SPIRA® Anterior Lumbar Spacers K234077 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Camber Spine Technologies. Cleared Jul 2024. https://www.510kdatabase.net/k234124/ 2024-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k234124-single-use-hemoclips-fda-510k.jpg K234124 - Single Use Hemoclips K234124 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Promisemed Hangzhou Meditech Co., Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k240240/ 2024-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k240240-inclusive-titanium-abutments-fda-510k.jpg K240240 - Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® Implant Systems K240240 is a FDA 510(k) cleared dental medical device. Manufacturer: Prismatik Dentalcraft, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k240247/ 2024-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k240247-mofi-cell-culture-basal-medium-fda-510k.jpg K240247 - “MoFi” Cell Culture Basal Medium K240247 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Duogenic Stemcells Corporation. Cleared Jul 2024. https://www.510kdatabase.net/k240651/ 2024-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k240651-mri-universal-fda-510k.jpg K240651 - MRI Universal K240651 is a FDA 510(k) cleared dental medical device. Manufacturer: Stryker Leibinger GmbH & Co KG. Cleared Jul 2024. https://www.510kdatabase.net/k240661/ 2024-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k240661-geistlich-bio-oss-fda-510k.jpg K240661 - Geistlich Bio-Oss® K240661 is a FDA 510(k) cleared dental medical device. Manufacturer: Geistlich Pharma AG. Cleared Jul 2024. https://www.510kdatabase.net/k240920/ 2024-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k240920-hemocare-bicarbonate-concentrate-set-bcs-fda-510k.jpg K240920 - HemoCare Bicarbonate Concentrate Set (BCS) K240920 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Deka Research and Development. Cleared Jul 2024. https://www.510kdatabase.net/k241018/ 2024-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k241018-kls-martin-orthopedic-implants-mr-fda-510k.jpg K241018 - KLS Martin Orthopedic Implants - MR Conditional K241018 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: KLS-Martin L.P.. Cleared Jul 2024. https://www.510kdatabase.net/k241031/ 2024-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k241031-tmini-miniature-robotic-system-tmini-11-fda-510k.jpg K241031 - TMINI Miniature Robotic System (TMINI 1.1) K241031 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: THINK Surgical, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k241085/ 2024-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k241085-valleylab-ft10-energy-platform-fda-510k.jpg K241085 - Valleylab ™FT10 Energy Platform Software Version 5.0 (VLFT10GEN VLFT10FXGEN VLFT10LSGEN) K241085 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien, LLC. Cleared Jul 2024. https://www.510kdatabase.net/k241378/ 2024-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k241378-sin-instrument-kits-fda-510k.jpg K241378 - S.I.N. Instrument Kits K241378 is a FDA 510(k) cleared general hospital medical device. Manufacturer: S.I.N. ? Sistema DE Implante Nacional S.A.. Cleared Jul 2024. https://www.510kdatabase.net/k241500/ 2024-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k241500-endoscopic-video-image-processor-rp-fda-510k.jpg K241500 - Endoscopic Video Image Processor (RP-IPD-V2000EF) K241500 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Guangzhou Red Pine Medical Instrument Co., Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k241705/ 2024-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k241705-milkmate-breast-pump-a0006-fda-510k.jpg K241705 - MilkMate Breast Pump (A0006) K241705 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Milkmate Products, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k241707/ 2024-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k241707-ocusoft-amenity-linofilcon-a-daily-fda-510k.jpg K241707 - OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ K241707 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Unicon Optical Co., Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k241713/ 2024-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k241713-hirise-1040-230-fda-510k.jpg K241713 - HiRise (1040-230) K241713 is a FDA 510(k) cleared radiology medical device. Manufacturer: Curvebeam, LLC. Cleared Jul 2024. https://www.510kdatabase.net/k241715/ 2024-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k241715-dental-glass-ceramics-blocks-htltst-fda-510k.jpg K241715 - Dental Glass Ceramics Blocks (HT,LT,ST) K241715 is a FDA 510(k) cleared dental medical device. Manufacturer: Aidite (Qinhuangdao) Technology Co., Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k241720/ 2024-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k241720-versacross-connect-transseptal-dilator-fda-510k.jpg K241720 - VersaCross Connect™ Transseptal Dilator K241720 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baylis Medical Company, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k241727/ 2024-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k241727-briefcase-triage-fda-510k.jpg K241727 - BriefCase-Triage K241727 is a FDA 510(k) cleared radiology medical device. Manufacturer: Aidoc Medical , Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/den220042/ 2024-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/den220042-terragene-bionova-photon-biological-fda-510k.jpg DEN220042 - Terragene Bionova Photon Biological Indicator (BT225) DEN220042 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terragene S.A.. Cleared Jul 2024. https://www.510kdatabase.net/k233791/ 2024-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k233791-drivewire-24-guidewire-fda-510k.jpg K233791 - Drivewire 24 Guidewire K233791 is a FDA 510(k) cleared neurology medical device. Manufacturer: Rapid Medical , Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k233874/ 2024-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k233874-tmcmf-solution-fda-510k.jpg K233874 - tmCMF Solution K233874 is a FDA 510(k) cleared dental medical device. Manufacturer: Techmah Cmf. Cleared Jul 2024. https://www.510kdatabase.net/k240493/ 2024-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k240493-cusa-clarity-ultrasonic-surgical-fda-510k.jpg K240493 - CUSA® Clarity Ultrasonic Surgical Aspirator System K240493 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Integra LifeSciences Corporation. Cleared Jul 2024. https://www.510kdatabase.net/k241000/ 2024-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k241000-attune-revision-knee-system-fda-510k.jpg K241000 - ATTUNE™ Revision Knee System K241000 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Ireland UC. Cleared Jul 2024. https://www.510kdatabase.net/k241006/ 2024-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k241006-natural-cycles-fda-510k.jpg K241006 - Natural Cycles K241006 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Natural Cycles Nordic AB. Cleared Jul 2024. https://www.510kdatabase.net/k241022/ 2024-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k241022-sterile-single-use-tip-cleaner-wk800-fda-510k.jpg K241022 - Sterile single use tip cleaner (WK800-S10 , WK800-S20) K241022 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd. Cleared Jul 2024. https://www.510kdatabase.net/k241329/ 2024-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k241329-subtlesynth-1x-fda-510k.jpg K241329 - SubtleSYNTH (1.x) K241329 is a FDA 510(k) cleared radiology medical device. Manufacturer: Subtle Medical, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k241460/ 2024-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k241460-manual-wheelchair-fda-510k.jpg K241460 - Manual Wheelchair K241460 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Lichtmega Technology Co., Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k241706/ 2024-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k241706-micromatrix-ubm-particulate-fda-510k.jpg K241706 - MicroMatrix® UBM Particulate K241706 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Acell, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k241711/ 2024-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k241711-oscar-peripheral-multifunctional-fda-510k.jpg K241711 - Oscar Peripheral Multifunctional Catheter system K241711 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biotronik, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k241724/ 2024-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k241724-cytal-wound-matrix-fda-510k.jpg K241724 - Cytal® Wound Matrix K241724 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Acell, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k232177/ 2024-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k232177-lightin-system-lightin-lightin-generator-fda-510k.jpg K232177 - Lightin System, Lightin, Lightin Generator K232177 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Solmedix Co., Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k233453/ 2024-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k233453-applied-biosystems-taqpath-covid-19-fda-510k.jpg K233453 - Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Kit K233453 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Life Technologies Corporation. Cleared Jul 2024. https://www.510kdatabase.net/k233628/ 2024-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k233628-aos-interstitial-templates-needles-and-fda-510k.jpg K233628 - AOS Interstitial Templates, Needles, and Accessories K233628 is a FDA 510(k) cleared radiology medical device. Manufacturer: Alpha-Omega Services, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k240016/ 2024-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k240016-ipl-hair-removal-device-yt01yt02yt03yt04-fda-510k.jpg K240016 - IPL Hair Removal Device (YT01,YT02,YT03,YT04) K240016 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Jianrong Biomedical Electronics Co., Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k240527/ 2024-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k240527-hydromark-plus-breast-biopsy-site-fda-510k.jpg K240527 - HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6) K240527 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Devicor Medical Products, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k240614/ 2024-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k240614-sentio-ti-implant-kit-fda-510k.jpg K240614 - Sentio Ti Implant Kit K240614 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Oticon Medical AB. Cleared Jul 2024. https://www.510kdatabase.net/k240666/ 2024-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k240666-affinity-fusion-oxygenator-with-fda-510k.jpg K240666 - Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811) K240666 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Perfusion Systems. Cleared Jul 2024. https://www.510kdatabase.net/k241426/ 2024-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k241426-gps-advanced-fda-510k.jpg K241426 - GPS Advanced K241426 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Prosidyan, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k241661/ 2024-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k241661-mojo-2-full-face-vented-mask-fda-510k.jpg K241661 - Mojo 2 Full Face Vented Mask K241661 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sleepnet Corporation. Cleared Jul 2024. https://www.510kdatabase.net/k241683/ 2024-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k241683-sterling-monorail-pta-balloon-fda-510k.jpg K241683 - Sterling™ MONORAIL™ PTA Balloon Dilatation Catheter (H74939031404020 ) K241683 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Jul 2024. https://www.510kdatabase.net/k232551/ 2024-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k232551-em-07-cordless-endo-motor-fda-510k.jpg K232551 - EM-07 Cordless Endo Motor K232551 is a FDA 510(k) cleared dental medical device. Manufacturer: Forum Engineering Technologies (96) , Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k233937/ 2024-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k233937-ow100s-fda-510k.jpg K233937 - OW100S K233937 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Softwave/Trt, LLC. Cleared Jul 2024. https://www.510kdatabase.net/k240610/ 2024-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k240610-deeplive-fda-510k.jpg K240610 - deepLive K240610 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Damae Medical. Cleared Jul 2024. https://www.510kdatabase.net/k240966/ 2024-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k240966-prima-plus-conical-implant-system-fda-510k.jpg K240966 - Prima Plus Conical Implant System K240966 is a FDA 510(k) cleared dental medical device. Manufacturer: Keystone Dental, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k241019/ 2024-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k241019-aprevo-tlif-c-articulating-system-fda-510k.jpg K241019 - aprevo® TLIF-C Articulating System K241019 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Carlsmed. Cleared Jul 2024. https://www.510kdatabase.net/k241316/ 2024-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k241316-zirconia-block-fda-510k.jpg K241316 - Zirconia Block K241316 is a FDA 510(k) cleared dental medical device. Manufacturer: Hunan Hualian Special Ceramics Co., Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k241343/ 2024-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k241343-ipl-hair-removal-device-ls-t121-ls-fda-510k.jpg K241343 - IPL Hair Removal Device (LS-T121, LS-T121A, LS-T121B, LS-T121C, LS-T130, LS-T130A, LST130B, LS-T133, LS-T135, LS-T136, LS-T137, LS-T134, LS-T138, LS-T139, LS-T140) K241343 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Lescolton Electrical Appliance Co., Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k241372/ 2024-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k241372-advisor-hd-grid-x-mapping-catheter-fda-510k.jpg K241372 - Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™ K241372 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared Jul 2024. https://www.510kdatabase.net/k233584/ 2024-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k233584-rhythmstar-system-fda-510k.jpg K233584 - RhythmStar System K233584 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: RhythMedix, LLC. Cleared Jul 2024. https://www.510kdatabase.net/k240502/ 2024-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k240502-da-vinci-sp-surgical-system-sp1098-fda-510k.jpg K240502 - da Vinci SP Surgical System (SP1098) K240502 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k241293/ 2024-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k241293-led-light-therapy-device-elixir-md-fda-510k.jpg K241293 - LED Light Therapy Device, ELIXIR MD™ K241293 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Yassen Wellness, LLC. Cleared Jul 2024. https://www.510kdatabase.net/k234082/ 2024-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k234082-sterrad-100nx-sterilizer-with-allclear-fda-510k.jpg K234082 - STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104) K234082 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Advanced Sterilization Products. Cleared Jul 2024. https://www.510kdatabase.net/k234084/ 2024-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k234084-sterrad-chemical-indicator-ci-strip-fda-510k.jpg K234084 - STERRAD™ Chemical Indicator (CI) Strip (14100) K234084 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Advanced Sterilization Products, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k240120/ 2024-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k240120-merlexi-craft-bariatric-series-of-fda-510k.jpg K240120 - Merlexi Craft Bariatric series of manual wheelchairs K240120 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Turbo Wheelchair Co., Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k240252/ 2024-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k240252-unicel-dxh-900-coulter-cellular-fda-510k.jpg K240252 - UniCel DxH 900 Coulter Cellular Analysis System K240252 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k241111/ 2024-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k241111-amt-suture-passer-fda-510k.jpg K241111 - AMT Suture Passer K241111 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Applied Medical Technology, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k241305/ 2024-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k241305-liferay-intraoral-handheld-x-ray-system-fda-510k.jpg K241305 - LifeRay Intraoral Handheld X-ray System K241305 is a FDA 510(k) cleared radiology medical device. Manufacturer: Lucas Lifecare. Cleared Jul 2024. https://www.510kdatabase.net/k241625/ 2024-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k241625-anatase-navi-disposable-instrument-fda-510k.jpg K241625 - Anatase Navi Disposable Instrument K241625 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Remex Medical Corp.. Cleared Jul 2024. https://www.510kdatabase.net/k241649/ 2024-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k241649-duo1-and-duo2-fda-510k.jpg K241649 - DUO1 and DUO2 K241649 is a FDA 510(k) cleared radiology medical device. Manufacturer: Zinnovi, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k241660/ 2024-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k241660-sioxd-wound-matrix-fda-510k.jpg K241660 - SiOxD® Wound Matrix K241660 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sioxmed, LLC. Cleared Jul 2024. https://www.510kdatabase.net/k233574/ 2024-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k233574-total-wrist-arthroplasty-system-twa-fda-510k.jpg K233574 - Total Wrist Arthroplasty System (TWA) K233574 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Skeletal Dynamics. Cleared Jul 2024. https://www.510kdatabase.net/k240009/ 2024-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k240009-iqflex-pro-fda-510k.jpg K240009 - iQFlex Pro K240009 is a FDA 510(k) cleared radiology medical device. Manufacturer: First Source, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k240052/ 2024-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k240052-disposable-enteral-feeding-sets-fda-510k.jpg K240052 - Disposable Enteral Feeding Sets K240052 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Beijing L&Z Medical Technology Development Co., Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k240946/ 2024-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k240946-gastric-alimetry-fda-510k.jpg K240946 - Gastric Alimetry K240946 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Alimetry , Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k240987/ 2024-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k240987-access-stfr-fda-510k.jpg K240987 - Access sTfR K240987 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k240996/ 2024-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k240996-access-thyroglobulin-antibody-ii-fda-510k.jpg K240996 - Access Thyroglobulin Antibody II K240996 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k241129/ 2024-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k241129-upper-arm-electronic-blood-pressure-fda-510k.jpg K241129 - Upper Arm Electronic Blood Pressure Monitor K241129 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Goodlymed Technology Co., Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k241277/ 2024-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k241277-ossiofiber-threaded-trimmable-fixation-fda-510k.jpg K241277 - OSSIOfiber® Threaded Trimmable Fixation Nail K241277 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OSSIO , Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k241284/ 2024-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k241284-da-vinci-surgical-system-is5000-fda-510k.jpg K241284 - da Vinci Surgical System (IS5000) K241284 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k241371/ 2024-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k241371-visera-s-video-system-center-olympus-fda-510k.jpg K241371 - VISERA S VIDEO SYSTEM CENTER OLYMPUS OTV-S500 (OLYMPUS OTV-S500) K241371 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Olympus Medical Systems Corporation. Cleared Jul 2024. https://www.510kdatabase.net/k241508/ 2024-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k241508-skout-system-fda-510k.jpg K241508 - SKOUT® system K241508 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Iterative Scopes, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k241577/ 2024-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k241577-iconix-anchor-fda-510k.jpg K241577 - Iconix® Anchor K241577 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Riverpoint Medical. Cleared Jul 2024. https://www.510kdatabase.net/k241591/ 2024-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k241591-blue-eye-fda-510k.jpg K241591 - Blue Eye K241591 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: The Standard Co., Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k241600/ 2024-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k241600-dermablate-fda-510k.jpg K241600 - Dermablate K241600 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Asclepion Laser Technologies GmbH. Cleared Jul 2024. https://www.510kdatabase.net/k241606/ 2024-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k241606-reprocessed-harmonic-1100-shears-5mm-fda-510k.jpg K241606 - Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120) K241606 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker Sustainability Solutions. Cleared Jul 2024. https://www.510kdatabase.net/k241615/ 2024-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k241615-transducer-probe-cover-fda-510k.jpg K241615 - Transducer Probe Cover K241615 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hony Medical Co., Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k241629/ 2024-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k241629-echelon-3000-45mm-compact-stapler-ech45c-fda-510k.jpg K241629 - ECHELON 3000 45mm Compact Stapler (ECH45C) K241629 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon Endo-Surgery, LLC. Cleared Jul 2024. https://www.510kdatabase.net/k232824/ 2024-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k232824-fluidshield-1-fog-free-procedure-mask-fda-510k.jpg K232824 - FLUIDSHIELD* 1 Fog-Free Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, White (41802) K232824 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Owens & Minor (O&M) Halyard, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k233415/ 2024-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k233415-deltawave-nasal-pillows-system-fda-510k.jpg K233415 - DELTAWAVE Nasal Pillows System K233415 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Remsleep Holdings. Cleared Jul 2024. https://www.510kdatabase.net/k233440/ 2024-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k233440-avalon-cl-fetal-maternal-fm-pod-866488-fda-510k.jpg K233440 - Avalon CL Fetal & Maternal (F&M) Pod (866488), Avalon CL Fetal & Maternal (F&M) Patch (989803196341) K233440 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Philips Medizin Systeme Boeblingen GmbH. Cleared Jul 2024. https://www.510kdatabase.net/k233626/ 2024-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k233626-aos-marker-seeds-smg0242-025-fda-510k.jpg K233626 - AOS Marker Seeds (SMG0242-025) K233626 is a FDA 510(k) cleared radiology medical device. Manufacturer: Alpha-Omega Services, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k234074/ 2024-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k234074-next-generation-access-catheter-fda-510k.jpg K234074 - Next Generation Access Catheter K234074 is a FDA 510(k) cleared neurology medical device. Manufacturer: Balt USA, LLC. Cleared Jul 2024. https://www.510kdatabase.net/k234083/ 2024-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k234083-next-generation-aspiration-catheter-fda-510k.jpg K234083 - Next Generation Aspiration Catheter K234083 is a FDA 510(k) cleared neurology medical device. Manufacturer: Balt USA, LLC. Cleared Jul 2024. https://www.510kdatabase.net/k240555/ 2024-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k240555-tyto-insights-for-crackles-detection-fda-510k.jpg K240555 - Tyto Insights for Crackles Detection K240555 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Tyto Care , Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k240707/ 2024-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k240707-ultrasonic-scaler-wd-jy-b002wd-jy-fda-510k.jpg K240707 - Ultrasonic Scaler (WD-JY-B002,WD-JY-W001,WD-JY-R003,WD-JY-G004,WD-JY-B003,WD-JY-C006,WD-JY-M0014, WD-JY-N0015,WD-JY-N0016,WD-JY-N0017,WD-JY-E007, WD-JY-F008,WD-JY-A005,WD-JY-H009,WD-JY-I0011, WD-JY-K0012,WD-JY-K0013,WD-JY-K0014, WD-JY-L0013,WD-JY-L0014,WD-JY-L0015, WD-JY-L0016,WD-JY-L0017) K240707 is a FDA 510(k) cleared dental medical device. Manufacturer: Shenzhen Micro Electric Intelligence Co., Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k240736/ 2024-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k240736-smart-bun-yo-matic-x-ray-fda-510k.jpg K240736 - SMART Bun-Yo-Matic X-Ray K240736 is a FDA 510(k) cleared radiology medical device. Manufacturer: Disior, Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k240863/ 2024-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k240863-freedom-total-knee-system-fda-510k.jpg K240863 - Freedom® Total Knee System K240863 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Maxx Orthopedics, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k240915/ 2024-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k240915-zien-io-intraosseous-access-system-fda-510k.jpg K240915 - ZIEN IO Intraosseous Access System K240915 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zien Medical Technologies, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k240930/ 2024-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k240930-non-sterile-powder-free-nitrile-fda-510k.jpg K240930 - Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with 55 Chemotherapy Drugs and Fentanyl- Violet Blue K240930 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sri Trang Gloves (Thailand) Public Company Limited. Cleared Jul 2024. https://www.510kdatabase.net/k241300/ 2024-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k241300-viewpoint-6-fda-510k.jpg K241300 - ViewPoint 6 K241300 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare GmbH. Cleared Jul 2024. https://www.510kdatabase.net/k241330/ 2024-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k241330-fogarty-fortis-arterial-embolectomy-fda-510k.jpg K241330 - Fogarty Fortis Arterial Embolectomy Catheter K241330 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences. Cleared Jul 2024. https://www.510kdatabase.net/k241574/ 2024-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k241574-ifuse-torq-implant-system-fda-510k.jpg K241574 - iFuse TORQ® Implant System K241574 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SI-BONE, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k241622/ 2024-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k241622-extended-reservoir-fda-510k.jpg K241622 - Extended Reservoir K241622 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Medtronic Minimed. Cleared Jul 2024. https://www.510kdatabase.net/den240013/ 2024-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/den240013-magdi-system-fda-510k.jpg DEN240013 - MagDI System DEN240013 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Gt Metabolic Solutions, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k231015/ 2024-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k231015-reprocessed-super-torque-and-super-fda-510k.jpg K231015 - Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters K231015 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Innovative Health, LLC. Cleared Jul 2024. https://www.510kdatabase.net/k232777/ 2024-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k232777-fluidshield-1-procedure-mask-with-so-fda-510k.jpg K232777 - FLUIDSHIELD* 1 Procedure Mask with SO SOFT* Lining and SO SOFT* Earloops, Lavender (25868) K232777 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Owens & Minor (O&M) Halyard, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k232989/ 2024-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k232989-pulse-oximeter-aoj-70a-fda-510k.jpg K232989 - Pulse Oximeter (AOJ-70A) K232989 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen AOJ Medical Technology Co., Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k233477/ 2024-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k233477-cryo-straw-type-i-type-iii-fda-510k.jpg K233477 - Cryo-straw (Type I, Type III) K233477 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shandong Wego Ruisheng Medical Device Co., Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k233908/ 2024-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k233908-cneuro-cdat-fda-510k.jpg K233908 - cNeuro cDAT K233908 is a FDA 510(k) cleared radiology medical device. Manufacturer: Combinostics OY. Cleared Jul 2024. https://www.510kdatabase.net/k234061/ 2024-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k234061-starformer-fda-510k.jpg K234061 - StarFormer K234061 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fotona D.O.O.. Cleared Jul 2024. https://www.510kdatabase.net/k240070/ 2024-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k240070-profound-matrix-fda-510k.jpg K240070 - Profound Matrix K240070 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Candela Corporation. Cleared Jul 2024. https://www.510kdatabase.net/k240221/ 2024-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k240221-spectralis-hraoct-and-variants-fda-510k.jpg K240221 - SPECTRALIS HRA+OCT and variants K240221 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Heidelberg Engineering GmbH. Cleared Jul 2024. https://www.510kdatabase.net/k240353/ 2024-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k240353-hyper-insight-ich-fda-510k.jpg K240353 - Hyper Insight - ICH K240353 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sk, Inc.. Cleared Jul 2024. https://www.510kdatabase.net/k240477/ 2024-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k240477-saview-sh-38-uv-senofilcon-a-fda-510k.jpg K240477 - Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens K240477 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: St. shine Optical Co., Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k240536/ 2024-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k240536-wearable-breast-pump-model-s32-fda-510k.jpg K240536 - Wearable Breast Pump (Model S32) K240536 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shenzhen TPH Technology Co., Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k240572/ 2024-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k240572-valleylab-sm-smoke-management-pencil-fda-510k.jpg K240572 - Valleylab™ SM Smoke Management Pencil with Edge™ Blade Electrode, 10’ (3m) (VSMP10) K240572 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien, LLC. Cleared Jul 2024. https://www.510kdatabase.net/k240801/ 2024-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k240801-biosonic-us200-ultrasonic-scaler-fda-510k.jpg K240801 - BioSonic US200 Ultrasonic Scaler (60034537) K240801 is a FDA 510(k) cleared dental medical device. Manufacturer: Dent4you AG. Cleared Jul 2024. https://www.510kdatabase.net/k241202/ 2024-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k241202-electric-nasal-aspirator-htd2601us-fda-510k.jpg K241202 - Electric nasal aspirator (HTD2601US) K241202 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Hetaida Technology Co., Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/k241598/ 2024-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k241598-lithovue-elite-single-use-digital-fda-510k.jpg K241598 - LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure monitoring) (M0067940000) K241598 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Jul 2024. https://www.510kdatabase.net/k241639/ 2024-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k241639-single-use-video-ureterorenoscope-svu-fda-510k.jpg K241639 - Single-use Video Ureterorenoscope (SVU-220US) K241639 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Huger Medical Instrument Co., Ltd.. Cleared Jul 2024. https://www.510kdatabase.net/den240007/ 2024-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/den240007-biohealx-anal-fistula-device-fda-510k.jpg DEN240007 - BioHealx Anal Fistula Device DEN240007 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Signum Surgical Limited. Cleared Jul 2024. https://www.510kdatabase.net/k232865/ 2024-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k232865-magseed-pro-magnetic-marker-system-fda-510k.jpg K232865 - Magseed Pro Magnetic Marker System K232865 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Endomagnetics Ltd.,. Cleared Jun 2024. https://www.510kdatabase.net/k233637/ 2024-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k233637-cordis-britecross-support-catheter-fda-510k.jpg K233637 - Cordis BRITECROSS Support Catheter K233637 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis US Corp. Cleared Jun 2024. https://www.510kdatabase.net/k233823/ 2024-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k233823-ultrasonic-fetal-doppler-fda-510k.jpg K233823 - Ultrasonic Fetal Doppler K233823 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shenzhen Jamr Technology Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k240164/ 2024-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k240164-novaline-sp-c35-transducer-protector-fda-510k.jpg K240164 - NovaLine SP-C35 Transducer Protector (956007) K240164 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Bain Medical Equipment (Guangzhou) Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k240215/ 2024-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k240215-blue-400-fda-510k.jpg K240215 - BLUE 400 K240215 is a FDA 510(k) cleared neurology medical device. Manufacturer: Carl Zeiss Meditec, AG. Cleared Jun 2024. https://www.510kdatabase.net/k240320/ 2024-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k240320-patient-monitor-resparray-fda-510k.jpg K240320 - Patient Monitor (RespArray) K240320 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edan Instruments, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k240892/ 2024-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k240892-xsense-cryoablation-system-with-fda-510k.jpg K240892 - XSense Cryoablation System with Cryoprobes K240892 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: IceCure Medical , Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k240893/ 2024-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k240893-artfx-medical-cervical-peek-cages-fda-510k.jpg K240893 - ARTFX MEDICAL Cervical PEEK Cages K240893 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Artfx Medical. Cleared Jun 2024. https://www.510kdatabase.net/k240927/ 2024-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k240927-access-thyroglobulin-fda-510k.jpg K240927 - Access Thyroglobulin K240927 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k241154/ 2024-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k241154-electric-wheelchair-yfwb-63-fda-510k.jpg K241154 - Electric Wheelchair (YFWB-63) K241154 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: If Health (Xiamen) Intelligent Technology Co.,Ltd. Cleared Jun 2024. https://www.510kdatabase.net/k241204/ 2024-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k241204-topcem-veneer-light-cure-veneer-cement-fda-510k.jpg K241204 - TopCEM-Veneer Light Cure Veneer Cement K241204 is a FDA 510(k) cleared dental medical device. Manufacturer: Rizhao Huge Biomaterials Company, Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k241229/ 2024-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k241229-helloeyes-bio-plug-fda-510k.jpg K241229 - Hello,eyes® BIO Plug K241229 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Bio Optics Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k241406/ 2024-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k241406-lavieen-fda-510k.jpg K241406 - Lavieen K241406 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wontech Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k241540/ 2024-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k241540-nuvision-ultrasound-catheter-fda-510k.jpg K241540 - NUVISION™ Ultrasound Catheter K241540 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biosense Webster, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k241608/ 2024-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k241608-nordicmediva-fda-510k.jpg K241608 - nordicMEDiVA K241608 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nordicneurolab AS. Cleared Jun 2024. https://www.510kdatabase.net/k233357/ 2024-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k233357-esocool-thermal-regulation-catheter-fda-510k.jpg K233357 - EsoCool Thermal Regulation Catheter K233357 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nuvaira, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k233398/ 2024-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k233398-faros-surgical-system-fda-510k.jpg K233398 - Faros Surgical System K233398 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Oertli Instrumente AG. Cleared Jun 2024. https://www.510kdatabase.net/k233762/ 2024-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k233762-steroscope-sterilization-technology-fda-510k.jpg K233762 - SteroScope® Sterilization Technology System K233762 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ideate Medical, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k233983/ 2024-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k233983-swan-ganz-pacing-probe-and-catheters-fda-510k.jpg K233983 - Swan-Ganz Pacing Probe and Catheters K233983 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences. Cleared Jun 2024. https://www.510kdatabase.net/k240327/ 2024-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k240327-uniko-pointcloud-knee-instruments-fda-510k.jpg K240327 - UNIKO PointCloud™ Knee Instruments K240327 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Unik Orthopedics, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k240381/ 2024-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k240381-catalystem-femoral-stems-fda-510k.jpg K240381 - CATALYSTEM Femoral Stems K240381 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k240564/ 2024-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k240564-nuface-fix-fda-510k.jpg K240564 - NuFACE® FIX+ K240564 is a FDA 510(k) cleared neurology medical device. Manufacturer: Carol Cole Company Dba Nuface. Cleared Jun 2024. https://www.510kdatabase.net/k240717/ 2024-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k240717-3m-attest-rapid-readout-biological-fda-510k.jpg K240717 - 3M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E K240717 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Jun 2024. https://www.510kdatabase.net/k240823/ 2024-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k240823-els-extra-low-shrinkage-composite-els-fda-510k.jpg K240823 - els extra low shrinkage® composite & els extra low shrinkage® flow K240823 is a FDA 510(k) cleared dental medical device. Manufacturer: Saremco Dental AG. Cleared Jun 2024. https://www.510kdatabase.net/k240853/ 2024-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k240853-pathfinder-cr-system-fda-510k.jpg K240853 - Pathfinder® CR System K240853 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Neptune Medical, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k240938/ 2024-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k240938-the-optimotion-blue-plus-knee-system-fda-510k.jpg K240938 - The Optimotion™ Blue Plus Knee System K240938 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Optimotion Implants, LLC. Cleared Jun 2024. https://www.510kdatabase.net/k241212/ 2024-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k241212-magnetos-easypack-putty-fda-510k.jpg K241212 - MagnetOs Easypack Putty K241212 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Kuros Biosciences. Cleared Jun 2024. https://www.510kdatabase.net/k241506/ 2024-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k241506-annabella-double-breast-pump-ado-us23-fda-510k.jpg K241506 - Annabella Double Breast Pump (ADO-US23-1000) K241506 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Annabella Tech. Cleared Jun 2024. https://www.510kdatabase.net/k241509/ 2024-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k241509-tensems-units-sm9109a-sm9109b-fda-510k.jpg K241509 - TENS&EMS units (SM9109A, SM9109B) K241509 is a FDA 510(k) cleared neurology medical device. Manufacturer: Plexus Yoga, LLC Dba Chirp. Cleared Jun 2024. https://www.510kdatabase.net/k241520/ 2024-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k241520-mojo-2-full-face-non-vented-mask-fda-510k.jpg K241520 - Mojo 2 Full Face Non-Vented Mask K241520 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sleepnet Corporation. Cleared Jun 2024. https://www.510kdatabase.net/k241542/ 2024-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k241542-3m-attest-super-rapid-vaporized-fda-510k.jpg K241542 - 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD) K241542 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Jun 2024. https://www.510kdatabase.net/k241553/ 2024-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k241553-auryon-atherectomy-catheter-17mm-fda-510k.jpg K241553 - Auryon Atherectomy Catheter 1.7mm K241553 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Eximo Medical, Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/den230055/ 2024-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/den230055-fsyx-ocular-pressure-adjusting-pump-fda-510k.jpg DEN230055 - FSYX™ Ocular Pressure Adjusting Pump (FSYX™ OPAP) System DEN230055 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Balance Ophthalmics, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/den240016/ 2024-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/den240016-xpert-hcv-fda-510k.jpg DEN240016 - Xpert HCV DEN240016 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Cepheid. Cleared Jun 2024. https://www.510kdatabase.net/k222771/ 2024-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k222771-sample-preservative-fluid-fda-510k.jpg K222771 - Sample Preservative Fluid K222771 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Hangzhou Bioer Technology Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k232829/ 2024-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k232829-versalock-rib-and-sternum-plates-system-fda-510k.jpg K232829 - Versalock Rib and Sternum Plates System K232829 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: GM Dos Reis Industria e Comercio Ltda.. Cleared Jun 2024. https://www.510kdatabase.net/k232987/ 2024-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k232987-flowart-valve-for-vial-access-fda-510k.jpg K232987 - FlowArt Valve for Vial Access K232987 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Asset Medikal Tasarim Sanayi VE Ticaret A.S.. Cleared Jun 2024. https://www.510kdatabase.net/k233354/ 2024-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k233354-wvsm-pro-series-500-0030-xx-fda-510k.jpg K233354 - WVSM Pro (Series) (500-0030-XX) K233354 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Athena Gtx, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k233380/ 2024-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k233380-trident-mobile-fluoroscopy-system-fda-510k.jpg K233380 - TRIDENT Mobile Fluoroscopy System K233380 is a FDA 510(k) cleared radiology medical device. Manufacturer: Dornier Medtech America. Cleared Jun 2024. https://www.510kdatabase.net/k233413/ 2024-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k233413-ultraphon-chemical-indicator-tro-t-and-fda-510k.jpg K233413 - Ultraphon Chemical Indicator (TRO-T and TRO-B) K233413 is a FDA 510(k) cleared general hospital medical device. Manufacturer: True Indicating, LLC. Cleared Jun 2024. https://www.510kdatabase.net/k233579/ 2024-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k233579-sc1-handheld-ultrasound-imaging-system-fda-510k.jpg K233579 - SC1 Handheld Ultrasound Imaging system (Model: SC1) K233579 is a FDA 510(k) cleared radiology medical device. Manufacturer: Fcu Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k233840/ 2024-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k233840-endoscopic-fluorescence-camera-system-fda-510k.jpg K233840 - Endoscopic Fluorescence Camera System (DPM-ENDOCAM-03PF) K233840 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Zhuhai Dipu Medical Technology Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k234059/ 2024-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k234059-forma-medical-optimal-plating-system-fda-510k.jpg K234059 - Forma Medical Optimal Plating System K234059 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Forma Medical, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k240875/ 2024-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k240875-unity-knee-ps-c-tibial-insert-fda-510k.jpg K240875 - Unity Knee PS-C Tibial Insert K240875 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corin U.S.A. Limited. Cleared Jun 2024. https://www.510kdatabase.net/k241133/ 2024-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k241133-magnifico-open-100009900-fda-510k.jpg K241133 - Magnifico Open (100009900) K241133 is a FDA 510(k) cleared radiology medical device. Manufacturer: Esaote, S.P.A.. Cleared Jun 2024. https://www.510kdatabase.net/k241507/ 2024-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k241507-aln-optional-vena-cava-filter-fb010500-fda-510k.jpg K241507 - ALN Optional Vena Cava Filter (FB.010500, FF.010995, FJ.120096, FB.HOOK, FF.HOOK, FJ.HOOK) K241507 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Aln S.A.R.L.. Cleared Jun 2024. https://www.510kdatabase.net/k232111/ 2024-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k232111-neobeat-neobeat-mini-fda-510k.jpg K232111 - NeoBeat, NeoBeat Mini K232111 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Laerdal Medical AS. Cleared Jun 2024. https://www.510kdatabase.net/k232640/ 2024-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k232640-venowave-vw5-fda-510k.jpg K232640 - Venowave VW5 K232640 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Thermabright. Cleared Jun 2024. https://www.510kdatabase.net/k233006/ 2024-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k233006-myndmove-myndmove-20-fda-510k.jpg K233006 - MyndMove, MyndMove 2.0 K233006 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Myndtec, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k233368/ 2024-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k233368-allograft-delivery-device-ofac-c-fda-510k.jpg K233368 - Allograft Delivery Device (OFAC-C) K233368 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bioventus, LLC. Cleared Jun 2024. https://www.510kdatabase.net/k240582/ 2024-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k240582-vea-align-fda-510k.jpg K240582 - VEA Align K240582 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eos Imaging. Cleared Jun 2024. https://www.510kdatabase.net/k240824/ 2024-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k240824-disposable-medical-nitrile-examination-fda-510k.jpg K240824 - Disposable Medical Nitrile Examination Gloves (Non sterile) (QN-N001, QN-N002, QN-N003, QN-N004, QN-N005) K240824 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ningxia Qiaoen Medical Technology Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k241035/ 2024-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k241035-pmt-posterior-cervical-stabilization-fda-510k.jpg K241035 - PMT Posterior Cervical Stabilization System (PCSS) K241035 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Providence Medical Technology, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k241158/ 2024-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k241158-asahi-veloute-fda-510k.jpg K241158 - ASAHI Veloute K241158 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Asahi Intecc Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k232952/ 2024-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k232952-copran-zri-fda-510k.jpg K232952 - Copran Zri K232952 is a FDA 510(k) cleared dental medical device. Manufacturer: Whitepeaks Dental Solutions GmbH. Cleared Jun 2024. https://www.510kdatabase.net/k233123/ 2024-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k233123-silkro-fda-510k.jpg K233123 - SILKRO K233123 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Hironic Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k233204/ 2024-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k233204-philips-intellisite-pathology-solution-fda-510k.jpg K233204 - Philips IntelliSite Pathology Solution 5.1 K233204 is a FDA 510(k) cleared pathology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Jun 2024. https://www.510kdatabase.net/k233288/ 2024-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k233288-nlz-built-in-motor-system-fda-510k.jpg K233288 - NLZ Built-In Motor System K233288 is a FDA 510(k) cleared dental medical device. Manufacturer: Nakanishi, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k233630/ 2024-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k233630-ambu-ascope-5-uretero-standard-fda-510k.jpg K233630 - Ambu® aScope™ 5 Uretero (Standard Deflection) K233630 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ambu A/S. Cleared Jun 2024. https://www.510kdatabase.net/k240259/ 2024-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k240259-apex-3d-total-ankle-replacement-system-fda-510k.jpg K240259 - APEX 3D Total Ankle Replacement System K240259 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paragon 28, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k241120/ 2024-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k241120-intense-pulsed-light-therapy-apparatus-fda-510k.jpg K241120 - Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S) K241120 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Qiaocheng LI (Dongguan) Medical Instruments Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k241144/ 2024-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k241144-picosecond-ndyag-laser-picocaremajesty-fda-510k.jpg K241144 - Picosecond Nd:YAG Laser (PICOCAREMAJESTY) K241144 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wontech Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k232807/ 2024-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k232807-fluidshield-1-procedure-mask-with-so-fda-510k.jpg K232807 - Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869) K232807 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Owens & Minor (O&M) Halyard, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k232975/ 2024-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k232975-pulse-oximeter-md300c228-fda-510k.jpg K232975 - Pulse Oximeter (MD300C228) K232975 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Beijing Choice Electronic Technology Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k233096/ 2024-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k233096-pressurealert-pressure-monitoring-system-fda-510k.jpg K233096 - PRESSUREALERT® Pressure Monitoring System K233096 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Position Health, LLC. Cleared Jun 2024. https://www.510kdatabase.net/k233196/ 2024-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k233196-medihub-prostate-fda-510k.jpg K233196 - Medihub Prostate K233196 is a FDA 510(k) cleared radiology medical device. Manufacturer: JLK, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k233230/ 2024-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k233230-see-factor-ct3-fda-510k.jpg K233230 - See Factor CT3™ K233230 is a FDA 510(k) cleared radiology medical device. Manufacturer: Epica International, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k233240/ 2024-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k233240-gerdx-system-fda-510k.jpg K233240 - GERDX-System K233240 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: G-Surg GmbH. Cleared Jun 2024. https://www.510kdatabase.net/k233253/ 2024-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k233253-ecartv5-clinical-deterioration-suite-fda-510k.jpg K233253 - eCARTv5 Clinical Deterioration Suite (“eCART”) K233253 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Agilemd, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k233259/ 2024-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k233259-xerosyn-fda-510k.jpg K233259 - Xerosyn K233259 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Xerothera, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k233280/ 2024-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k233280-steadytemp-fda-510k.jpg K233280 - SteadyTemp K233280 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Steadysense GmbH. Cleared Jun 2024. https://www.510kdatabase.net/k233322/ 2024-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k233322-mochida-nerve-cuff-fda-510k.jpg K233322 - Mochida Nerve Cuff K233322 is a FDA 510(k) cleared neurology medical device. Manufacturer: Mochida Pharmaceutical Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k233326/ 2024-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k233326-merge-hemo-model-rcsv2-fda-510k.jpg K233326 - Merge Hemo, Model RCSV2 K233326 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merge Healthcare Incorporated. Cleared Jun 2024. https://www.510kdatabase.net/k233361/ 2024-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k233361-sunny-cup-and-applicator-fda-510k.jpg K233361 - Sunny Cup and Applicator K233361 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Menstrual Mates. Cleared Jun 2024. https://www.510kdatabase.net/k233549/ 2024-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k233549-tempus-ecg-af-fda-510k.jpg K233549 - Tempus ECG-AF K233549 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Tempus AI, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k233876/ 2024-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k233876-unity-vcs-8065000296-fda-510k.jpg K233876 - UNITY VCS (8065000296) K233876 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Alcon Laboratories, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k233885/ 2024-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k233885-rainbow-paste-stain-se-fda-510k.jpg K233885 - rainbow Paste Stain SE K233885 is a FDA 510(k) cleared dental medical device. Manufacturer: Genoss Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k234095/ 2024-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k234095-otonovaotonova-pro-fda-510k.jpg K234095 - OtoNova/OtoNova Pro K234095 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Otodynamics. Cleared Jun 2024. https://www.510kdatabase.net/k234155/ 2024-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k234155-nimbl-model-pd08-n1-fda-510k.jpg K234155 - Nimbl (model PD08-N1) K234155 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Tactile Medical. Cleared Jun 2024. https://www.510kdatabase.net/k240125/ 2024-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k240125-therm-x-home-fda-510k.jpg K240125 - Therm-X (Home) K240125 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Zenith Technical Innovations. Cleared Jun 2024. https://www.510kdatabase.net/k240387/ 2024-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k240387-minamo-blue-fda-510k.jpg K240387 - MINAMO blue K240387 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Asahi Intecc Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k240465/ 2024-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k240465-o-arm-o2-imaging-system-fda-510k.jpg K240465 - O-arm O2 Imaging System K240465 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medtronic Navigation, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k240631/ 2024-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k240631-v8xv8xh8-v7xv7xh7-v6xv6xh6-diagnostic-fda-510k.jpg K240631 - V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System K240631 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Medison Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k240643/ 2024-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k240643-misslan-early-detection-pregnancy-test-fda-510k.jpg K240643 - MissLan® Early Detection Pregnancy Test Strip K240643 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Guangzhou Decheng Biotechnology Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k240649/ 2024-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k240649-ice-cooling-ipl-hair-removal-device-fda-510k.jpg K240649 - Ice Cooling IPL Hair Removal Device (UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07 PN, UI07 RE, UI07 WH, UI07 PW, UI20 BR, UI20 DB, UI20 BL, UI20GP, UI20 PN, UI20 RE, UI20 WH, UI20 PW) K240649 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Ulike Smart Electronics Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k240663/ 2024-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k240663-single-use-video-flexible-cystoscope-fda-510k.jpg K240663 - Single-Use Video Flexible Cystoscope (RP-U-C0201/RP-U-C0201S) K240663 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Guangzhou Red Pine Medical Instrument Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k240728/ 2024-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k240728-cordx-tyfast-covid-19-ag-rapid-test-fda-510k.jpg K240728 - CorDx Tyfast COVID-19 Ag Rapid Test K240728 is a FDA 510(k) cleared microbiology medical device. Manufacturer: CorDx, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k240862/ 2024-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k240862-medicom-sterilization-wrap-fda-510k.jpg K240862 - Medicom Sterilization Wrap K240862 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medicom Group, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k241117/ 2024-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k241117-m6-c-single-use-disposable-fda-510k.jpg K241117 - M6-C™ Single Use, Disposable Instrumentation K241117 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinal Kinetics / Orthofix / Seaspine. Cleared Jun 2024. https://www.510kdatabase.net/k241442/ 2024-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k241442-ezsure-empty-fluid-container-with-fda-510k.jpg K241442 - eZSURE™ Empty Fluid Container with ProSeal™ Injection Site K241442 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Epic Medical Pte. , Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k241459/ 2024-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k241459-motus-pro-family-fda-510k.jpg K241459 - MOTUS PRO Family K241459 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: El.En S.P.A.. Cleared Jun 2024. https://www.510kdatabase.net/k241476/ 2024-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k241476-toxiseal-vial-adaptor-with-external-fda-510k.jpg K241476 - ToxiSeal™ Vial Adaptor with External Flip Balloon K241476 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Epic Medical Pte. , Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k241519/ 2024-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k241519-invictus-small-stature-spinal-fixation-fda-510k.jpg K241519 - Invictus® Small Stature Spinal Fixation System K241519 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k230675/ 2024-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k230675-vitek-reveal-gn-ast-assay-and-vitek-fda-510k.jpg K230675 - VITEK REVEAL GN AST Assay and VITEK REVEAL AST System K230675 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Specific Diagnostics, LLC. Cleared Jun 2024. https://www.510kdatabase.net/k232161/ 2024-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k232161-deeprhythm-platform-fda-510k.jpg K232161 - DeepRhythm Platform K232161 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medicalgorithmics S.A.. Cleared Jun 2024. https://www.510kdatabase.net/k233117/ 2024-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k233117-surgic-pro2-surgic-pro2-opt-surgic-fda-510k.jpg K233117 - Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT) K233117 is a FDA 510(k) cleared dental medical device. Manufacturer: Nakanishi, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k233158/ 2024-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k233158-copra-smile-copra-supreme-hyperion-fda-510k.jpg K233158 - Copra Smile, Copra Supreme Hyperion K233158 is a FDA 510(k) cleared dental medical device. Manufacturer: Whitepeaks Dental Solutions GmbH. Cleared Jun 2024. https://www.510kdatabase.net/k233162/ 2024-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k233162-freedom-peripheral-nerve-stimulator-fda-510k.jpg K233162 - Freedom Peripheral Nerve Stimulator (PNS) System K233162 is a FDA 510(k) cleared neurology medical device. Manufacturer: Curonix. Cleared Jun 2024. https://www.510kdatabase.net/k233225/ 2024-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k233225-schoelly-oxygen-saturation-imaging-osi-fda-510k.jpg K233225 - SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope) K233225 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Schoelly Fiberoptic GmbH. Cleared Jun 2024. https://www.510kdatabase.net/k240611/ 2024-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k240611-ivylaser-diode-laser-hair-removal-fda-510k.jpg K240611 - IVYLASER Diode laser hair removal system (IVY-HR-Alloy) K240611 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ivylaser (Beijing) Technology Co.,Ltd. Cleared Jun 2024. https://www.510kdatabase.net/k240613/ 2024-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k240613-aptus-elbow-dorsal-olecranon-plates-fda-510k.jpg K240613 - APTUS Elbow Dorsal Olecranon Plates K240613 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medartis AG. Cleared Jun 2024. https://www.510kdatabase.net/k240642/ 2024-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k240642-smart-bun-yo-matic-ct-fda-510k.jpg K240642 - SMART Bun-Yo-Matic CT K240642 is a FDA 510(k) cleared radiology medical device. Manufacturer: Disior, Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k240669/ 2024-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k240669-actify-3d-total-knee-system-actify-fda-510k.jpg K240669 - ACTIFY™ 3D Total Knee System, ACTIFY™ Total Knee System K240669 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k240673/ 2024-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k240673-electric-wheelchair-fda-510k.jpg K240673 - Electric wheelchair K240673 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zhejiang Hfizer Medical Equipment Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k240688/ 2024-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k240688-rodin-titan-3d-resin-fda-510k.jpg K240688 - RODIN Titan 3D Resin K240688 is a FDA 510(k) cleared dental medical device. Manufacturer: Belport Company, Inc., Gingi-Pak. Cleared Jun 2024. https://www.510kdatabase.net/k240830/ 2024-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k240830-reef-tota-system-fda-510k.jpg K240830 - Reef TO/TA System K240830 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthofix Medical, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k241435/ 2024-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k241435-q-fix-knotless-all-suture-anchor-18-mm-fda-510k.jpg K241435 - Q-FIX Knotless All-Suture Anchor, 1.8 mm, with one ULTRABRAID suture, blue K241435 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k241466/ 2024-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k241466-shoreline-acs-interbody-system-fda-510k.jpg K241466 - Shoreline ACS Interbody System K241466 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared Jun 2024. https://www.510kdatabase.net/k241627/ 2024-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k241627-safety-lancet-xxxv-fda-510k.jpg K241627 - Safety Lancet (XXXV) K241627 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Tianjin Huahong Technology Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k232997/ 2024-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k232997-evis-exera-iii-gastrointestinal-fda-510k.jpg K232997 - EVIS Exera III Gastrointestinal Videoscope GIF-1TH190 K232997 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Medical Systems Corporation. Cleared Jun 2024. https://www.510kdatabase.net/k233036/ 2024-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k233036-ultrasonic-surgical-system-fda-510k.jpg K233036 - Ultrasonic Surgical System K233036 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Hunan Handlike Minimally Invasive Surgery Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k233294/ 2024-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k233294-automatic-biopsy-needle-bam-semi-fda-510k.jpg K233294 - Automatic Biopsy Needle BAM, Semi-Automatic Needle BIM K233294 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Itp Innovative Tomography Products GmbH. Cleared Jun 2024. https://www.510kdatabase.net/k233553/ 2024-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k233553-minispacer-1024-1025-1543-and-1024a-fda-510k.jpg K233553 - MiniSpacer® 1024, 1025, 1543 and 1024A, 1025A, 1543A Dual Spray MDI Adapter K233553 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Thayer Medical Corporation. Cleared Jun 2024. https://www.510kdatabase.net/k233867/ 2024-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k233867-fitbone-trochanteric-fda-510k.jpg K233867 - Fitbone Trochanteric K233867 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthofix Srl. Cleared Jun 2024. https://www.510kdatabase.net/k240196/ 2024-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k240196-bladeless-trocar-e05-e10-e11-e12-es05-fda-510k.jpg K240196 - Bladeless Trocar (E05, E10, E11, E12, ES05, ES10, ES12) K240196 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Yuwonmeditech Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k240552/ 2024-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k240552-irrisept-antimicrobial-wound-lavage-fda-510k.jpg K240552 - Irrisept Antimicrobial Wound Lavage K240552 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Irrimax Corporation. Cleared Jun 2024. https://www.510kdatabase.net/k240583/ 2024-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k240583-ipl-home-use-hair-removal-device-d-fda-510k.jpg K240583 - IPL Home Use Hair Removal Device (D-1199, D-T099, D-T018, D-T019, D-T003B, D-T003W, D-T018Y, D-T019Y, D-1196B, D-1196W, D-1196C, D-1196C1, D-T099K, D-T099KW, D-T012, D-T012W) K240583 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k240678/ 2024-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k240678-attune-porous-fixed-bearing-tibial-fda-510k.jpg K240678 - ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM 3DP Technology K240678 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Ireland UC. Cleared Jun 2024. https://www.510kdatabase.net/k240774/ 2024-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k240774-pen-injector-fda-510k.jpg K240774 - Pen Injector K240774 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wuxi Nest Biotechnology Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k241412/ 2024-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k241412-invisalign-system-fda-510k.jpg K241412 - Invisalign System K241412 is a FDA 510(k) cleared dental medical device. Manufacturer: Align Technology, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k232258/ 2024-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k232258-xo-constrain-percutaneous-transluminal-fda-510k.jpg K232258 - XO Constrain™ Percutaneous Transluminal Angioplasty Constraining Catheter K232258 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Transit Scientific, LLC. Cleared Jun 2024. https://www.510kdatabase.net/k233060/ 2024-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k233060-elecsys-folate-iii-fda-510k.jpg K233060 - Elecsys Folate III K233060 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Jun 2024. https://www.510kdatabase.net/k233255/ 2024-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k233255-crossnav-navigation-enabled-instruments-fda-510k.jpg K233255 - CROSSNAV Navigation Enabled Instruments K233255 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Synthes. Cleared Jun 2024. https://www.510kdatabase.net/k233256/ 2024-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k233256-robotic-integration-instruments-fda-510k.jpg K233256 - Robotic Integration Instruments K233256 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Synthes. Cleared Jun 2024. https://www.510kdatabase.net/k233324/ 2024-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k233324-molecular-transport-media-mtm-fda-510k.jpg K233324 - Molecular Transport Media - MTM K233324 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Alb Luz. Cleared Jun 2024. https://www.510kdatabase.net/k233331/ 2024-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k233331-mediomx-fda-510k.jpg K233331 - MediOMx K233331 is a FDA 510(k) cleared radiology medical device. Manufacturer: Pmx, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k233987/ 2024-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k233987-veraband-fda-510k.jpg K233987 - VERABAND™ K233987 is a FDA 510(k) cleared neurology medical device. Manufacturer: Arbor Medical Innovations, LLC. Cleared Jun 2024. https://www.510kdatabase.net/k240684/ 2024-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k240684-resona-i9-resona-i9-exp-resona-i9s-fda-510k.jpg K240684 - Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9, Resona I9W, Recho I9, Recho I9 Pro, Recho I9 Exp, Recho I9S, Recho I9T Diagnostic Ultrasound System K240684 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k240747/ 2024-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k240747-medical-diode-laser-m2-gk-fda-510k.jpg K240747 - Medical Diode Laser (M2-GK) K240747 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wuhan Pioon Technology Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k241416/ 2024-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k241416-ion-3d-fda-510k.jpg K241416 - Ion 3D K241416 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SurGenTec, LLC. Cleared Jun 2024. https://www.510kdatabase.net/k241428/ 2024-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k241428-alltest-multi-drug-urine-test-cup-fda-510k.jpg K241428 - AllTest Multi-Drug Urine Test Cup K241428 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Hangzhou AllTest Biotech Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k231116/ 2024-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k231116-multi-parameter-detector-fda-510k.jpg K231116 - Multi-parameter detector K231116 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Zhongshan Jinli Electronic Weighing? Equipment Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k241469/ 2024-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k241469-iq-2-nasal-vented-mask-fda-510k.jpg K241469 - iQ 2 Nasal Vented Mask K241469 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sleepnet Corporation. Cleared Jun 2024. https://www.510kdatabase.net/k230668/ 2024-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k230668-disposable-high-pressure-extension-lines-fda-510k.jpg K230668 - Disposable High-pressure Extension Lines K230668 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Precision Medical Plastics , Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k232812/ 2024-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k232812-fluidshield-2-fog-free-surgical-mask-fda-510k.jpg K232812 - Fluidshield* 2 Fog-Free Surgical Mask (62113) K232812 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Owens & Minor (O&M) Halyard, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k232879/ 2024-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k232879-roche-digital-pathology-dx-ventana-dp-fda-510k.jpg K232879 - Roche Digital Pathology Dx (VENTANA DP 200) K232879 is a FDA 510(k) cleared pathology medical device. Manufacturer: Ventana Medical Systems, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k232893/ 2024-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k232893-pocket-fetal-doppler-contec-10d-pocket-fda-510k.jpg K232893 - Pocket Fetal Doppler (CONTEC 10D), Pocket Fetal Doppler (CONTEC 10E), Pocket Fetal Doppler (CONTEC 10F) K232893 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Contec Medical Systems Co.,Ltd. Cleared Jun 2024. https://www.510kdatabase.net/k233043/ 2024-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k233043-smart-scope-cx-fda-510k.jpg K233043 - Smart Scope® CX K233043 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Periwinkle Technologies Pvt., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k233079/ 2024-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k233079-zimmon-pancreatic-stentsstent-sets-fda-510k.jpg K233079 - Zimmon® Pancreatic Stents/Stent sets (SPSOF, SPSOS, ZEPDF, ZEPDS, ZPSOF, ZPSOS) K233079 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Ireland, Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k233228/ 2024-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k233228-spine-navigation-and-robotic-fda-510k.jpg K233228 - Spine Navigation and Robotic-Assistance Device K233228 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ecential Robotics. Cleared Jun 2024. https://www.510kdatabase.net/k233238/ 2024-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k233238-air-pressure-therapy-system-modelvu-fda-510k.jpg K233238 - Air Pressure Therapy System (Model:VU-IPC4M) K233238 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Xiamen Weiyou Intelligent Technology Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k233254/ 2024-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k233254-teligen-system-navigation-ready-fda-510k.jpg K233254 - TELIGEN System Navigation Ready Instruments K233254 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Synthes. Cleared Jun 2024. https://www.510kdatabase.net/k233496/ 2024-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k233496-endeavorotc-fda-510k.jpg K233496 - EndeavorOTC K233496 is a FDA 510(k) cleared neurology medical device. Manufacturer: Akili Interactive Labs, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k233707/ 2024-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k233707-hft150-fda-510k.jpg K233707 - HFT150 K233707 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Invent Medical Corporation. Cleared Jun 2024. https://www.510kdatabase.net/k233955/ 2024-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k233955-clarius-ob-ai-fda-510k.jpg K233955 - Clarius OB AI K233955 is a FDA 510(k) cleared radiology medical device. Manufacturer: Clarius Mobile Health Corp.. Cleared Jun 2024. https://www.510kdatabase.net/k233991/ 2024-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k233991-cangaroo-rm-antibacterial-envelope-fda-510k.jpg K233991 - CanGaroo RM Antibacterial Envelope K233991 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Elutia, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k240002/ 2024-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k240002-g-vitri-vitrification-straw-fda-510k.jpg K240002 - G-Vitri™ Vitrification Straw K240002 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Gimbo Medical Technology Shenzhen Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k240124/ 2024-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k240124-biosieve-fentanyl-fia-test-kit-fda-510k.jpg K240124 - BioSieve™ Fentanyl FIA Test Kit K240124 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Vivachek Biotech (Hangzhou) Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k240696/ 2024-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k240696-airdog-x8-air-purifier-kj800f-x8-fda-510k.jpg K240696 - Airdog X8 Air Purifier (KJ800F-X8) K240696 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Suzhou Beiang Smart Technology Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k240721/ 2024-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k240721-excelsiusflex-fda-510k.jpg K240721 - ExcelsiusFlex™ K240721 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k240729/ 2024-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k240729-electronic-blood-pressure-monitor-fda-510k.jpg K240729 - Electronic Blood Pressure Monitor (Model: PG-800B30, PG-800B38, PG-800B39, PG-800B45, PG-800B46, PG-800B47, PG-800B48, PG-800B53, PG-800B55, PG-800B56, PG-800B57, PG-800B58, PG-800B61) K240729 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Pango Medical Electronics Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k240817/ 2024-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k240817-versawrap-fda-510k.jpg K240817 - VersaWrap K240817 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alafair Biosciences, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k241082/ 2024-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k241082-innoverse-navigation-instruments-fda-510k.jpg K241082 - INNOVERSE Navigation Instruments K241082 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Innosys Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k241083/ 2024-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k241083-sis-system-fda-510k.jpg K241083 - SIS System K241083 is a FDA 510(k) cleared radiology medical device. Manufacturer: Surgical Information Sciences, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k241250/ 2024-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k241250-3dmax-light-mesh-fda-510k.jpg K241250 - 3DMax Light Mesh K241250 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Davol Inc., Subsidiary of C. R. Bard, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k241407/ 2024-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k241407-splendor-x-alex-alex2-ndyag-alexndyag-fda-510k.jpg K241407 - Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG) K241407 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bios S.R.L.. Cleared Jun 2024. https://www.510kdatabase.net/k231060/ 2024-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k231060-promin-dental-desensitizing-gel-fda-510k.jpg K231060 - ProMin Dental Desensitizing Gel K231060 is a FDA 510(k) cleared dental medical device. Manufacturer: Belport Company, Inc., Gingi-Pak. Cleared Jun 2024. https://www.510kdatabase.net/k232930/ 2024-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k232930-verve-fda-510k.jpg K232930 - VERVE K232930 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Oculomotor Technologies. Cleared Jun 2024. https://www.510kdatabase.net/k232953/ 2024-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k232953-aquabplus-fda-510k.jpg K232953 - AquaBplus K232953 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC. Cleared Jun 2024. https://www.510kdatabase.net/k233321/ 2024-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k233321-double-balloon-endoscope-en-840t-over-fda-510k.jpg K233321 - Double Balloon Endoscope EN-840T, Over-tube TS-1214C K233321 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fujifilm Healthcare Americas Corporation. Cleared Jun 2024. https://www.510kdatabase.net/k233662/ 2024-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k233662-radiography-7300-c-fda-510k.jpg K233662 - Radiography 7300 C K233662 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Dmc GmbH. Cleared Jun 2024. https://www.510kdatabase.net/k233821/ 2024-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k233821-fp-optiflow-oxygen-kit-aa451j-fda-510k.jpg K233821 - F&P Optiflow Oxygen Kit (AA451J) K233821 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Fisher &Paykel Healthcare , Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k233892/ 2024-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k233892-3d-endoscopic-fluorescence-camera-fda-510k.jpg K233892 - 3D Endoscopic Fluorescence Camera System (DPM-ENDOCAM-06PF) K233892 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Zhuhai Dipu Medical Technology Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k233925/ 2024-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k233925-relu-creator-fda-510k.jpg K233925 - Relu Creator K233925 is a FDA 510(k) cleared radiology medical device. Manufacturer: Relu BV. Cleared Jun 2024. https://www.510kdatabase.net/k240017/ 2024-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k240017-inmode-system-with-the-morpheus8-90-fda-510k.jpg K240017 - InMode System with the Morpheus8 90 Applicator K240017 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Inmode , Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k240149/ 2024-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k240149-giftlife-fertilization-medium-fda-510k.jpg K240149 - Giftlife™ Fertilization Medium K240149 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Gimbo Medical Technology Shenzhen Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k240460/ 2024-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k240460-fmd-peripheral-guide-wire-f-18-flex-fda-510k.jpg K240460 - FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259) K240460 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: FMD Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k240815/ 2024-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k240815-arthrex-cannulated-screw-system-fda-510k.jpg K240815 - Arthrex Cannulated Screw System K240815 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k241358/ 2024-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k241358-blu-u-blue-light-photodynamic-therapy-fda-510k.jpg K241358 - BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170E K241358 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sun Pharmaceutical Industries, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k241370/ 2024-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k241370-agilis-nxt-steerable-introducer-dual-fda-510k.jpg K241370 - Agilis™ NxT Steerable Introducer Dual-Reach™ (I-V2-MED) K241370 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared Jun 2024. https://www.510kdatabase.net/k241499/ 2024-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k241499-213-5mp-color-lcd-display-umd5-21b01-fda-510k.jpg K241499 - 21.3” 5MP Color LCD Display UMD5-21B01 K241499 is a FDA 510(k) cleared radiology medical device. Manufacturer: Acula Technology Corp.. Cleared Jun 2024. https://www.510kdatabase.net/k232950/ 2024-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k232950-sterile-disposable-syringe-sterile-fda-510k.jpg K232950 - Sterile Disposable Syringe, Sterile Disposable Syringe with needle, Sterile Disposable Syringe with safety needle K232950 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Perfect Medical Industry (Vn) Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k232967/ 2024-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k232967-vitek-2-ast-yeast-voriconazole-003125-fda-510k.jpg K232967 - VITEK 2 AST-Yeast Voriconazole (<= 0.03125 - >= 4 µg/mL) K232967 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k233007/ 2024-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k233007-picosecond-ndyag-laser-system-fda-510k.jpg K233007 - Picosecond Nd:YAG Laser System K233007 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ami, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k233266/ 2024-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k233266-mediblu-ecg-system-fda-510k.jpg K233266 - MEDIBLU ECG SYSTEM K233266 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Mediblu Medical, LLC. Cleared Jun 2024. https://www.510kdatabase.net/k233610/ 2024-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k233610-acuson-p500-ultrasound-system-fda-510k.jpg K233610 - ACUSON P500 Ultrasound System K233610 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k233613/ 2024-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k233613-acuson-sc2000-diagnostic-ultrasound-fda-510k.jpg K233613 - ACUSON SC2000 Diagnostic Ultrasound System K233613 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k240050/ 2024-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k240050-soundstar-crystal-ultrasound-catheter-fda-510k.jpg K240050 - SOUNDSTAR™ CRYSTAL Ultrasound Catheter K240050 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biosense Webster, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k240256/ 2024-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k240256-remunity-system-fda-510k.jpg K240256 - Remunity System K240256 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Deka Research and Development. Cleared Jun 2024. https://www.510kdatabase.net/k240504/ 2024-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k240504-plasma-edge-system-fda-510k.jpg K240504 - PLASMA EDGE System K240504 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Lamidey Noury Medical. Cleared Jun 2024. https://www.510kdatabase.net/k240516/ 2024-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k240516-rs85-diagnostic-ultrasound-system-fda-510k.jpg K240516 - RS85 Diagnostic Ultrasound System K240516 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Medison Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k240876/ 2024-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k240876-identity-shoulder-system-fda-510k.jpg K240876 - Identity Shoulder System K240876 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k240910/ 2024-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k240910-eo-chex-indicator-tape-fda-510k.jpg K240910 - EO Chex Indicator Tape K240910 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Propper Manufacturing Co., Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k241034/ 2024-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k241034-meta-bone-cement-must-fenestrated-fda-510k.jpg K241034 - Meta+ Bone Cement & M.U.S.T. Fenestrated Pedicle Screw System K241034 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Jun 2024. https://www.510kdatabase.net/k241352/ 2024-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k241352-affinity-nt-oxygenator-and-uncoated-fda-510k.jpg K241352 - Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541) K241352 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k221547/ 2024-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k221547-inactiv-blue-fda-510k.jpg K221547 - InActiv Blue K221547 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Fertipro NV. Cleared Jun 2024. https://www.510kdatabase.net/k230546/ 2024-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k230546-signex-fda-510k.jpg K230546 - SIGNEX K230546 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonic Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k232749/ 2024-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k232749-doopang-fda-510k.jpg K232749 - DOOPANG K232749 is a FDA 510(k) cleared neurology medical device. Manufacturer: Ybrain, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k241011/ 2024-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k241011-mako-total-knee-application-fda-510k.jpg K241011 - Mako Total Knee Application K241011 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Mako Surgical Corp.. Cleared Jun 2024. https://www.510kdatabase.net/k241025/ 2024-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k241025-jade-plus-pta-balloon-dilatation-fda-510k.jpg K241025 - JADE PLUS PTA Balloon Dilatation Catheter K241025 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: OrbusNeich Medical (Shenzhen) Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k241344/ 2024-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k241344-metricide-opa-plus-solution-test-strip-fda-510k.jpg K241344 - MetriCide™ OPA Plus Solution Test Strip K241344 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Steris. Cleared Jun 2024. https://www.510kdatabase.net/den230069/ 2024-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/den230069-mi-chord-system-fda-510k.jpg DEN230069 - Mi-CHORD System DEN230069 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Lsi Solutions, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k232911/ 2024-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k232911-karl-storz-flexible-uretero-reno-fda-510k.jpg K232911 - KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [positive deflection] (11278A2), KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [contra-positive deflection] (11278AU1) K232911 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Karl Storz Endovision, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k233767/ 2024-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k233767-omnitom-elite-fda-510k.jpg K233767 - OmniTom Elite K233767 is a FDA 510(k) cleared radiology medical device. Manufacturer: Neurologica Corporation. Cleared Jun 2024. https://www.510kdatabase.net/k234106/ 2024-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k234106-venue-fit-fda-510k.jpg K234106 - Venue Fit K234106 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared Jun 2024. https://www.510kdatabase.net/k240053/ 2024-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k240053-venue-go-fda-510k.jpg K240053 - Venue Go K240053 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared Jun 2024. https://www.510kdatabase.net/k240106/ 2024-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k240106-histofreezer-v-fda-510k.jpg K240106 - Histofreezer V K240106 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cryoconcepts LP. Cleared Jun 2024. https://www.510kdatabase.net/k240108/ 2024-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k240108-wrap-accessory-electrodes-gmx-absbelt01-fda-510k.jpg K240108 - Wrap Accessory Electrodes (GMX-ABSBELT01 K240108 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Gymmax Technology Shenzhen Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k240111/ 2024-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k240111-venue-fda-510k.jpg K240111 - Venue K240111 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared Jun 2024. https://www.510kdatabase.net/k240206/ 2024-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k240206-venue-sprint-fda-510k.jpg K240206 - Venue Sprint K240206 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared Jun 2024. https://www.510kdatabase.net/k240283/ 2024-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k240283-bubbleview-single-use-digital-flexible-fda-510k.jpg K240283 - BubbleView™ Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR) K240283 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: MacroLux Medical Technology Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k240644/ 2024-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k240644-medical-diode-laser-s1pro-fda-510k.jpg K240644 - Medical Diode Laser (S1Pro) K240644 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wuhan Pioon Technology Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k241399/ 2024-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k241399-indigo-lightning-flash-aspiration-fda-510k.jpg K241399 - Indigo® Lightning Flash Aspiration System – Select +™ Catheter K241399 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Penumbra, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k231010/ 2024-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k231010-corvair-fda-510k.jpg K231010 - Corvair K231010 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: AliveCor, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k232035/ 2024-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k232035-impala-fda-510k.jpg K232035 - Impala K232035 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: AliveCor, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k232625/ 2024-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k232625-steriking-pouch-for-robotic-instruments-fda-510k.jpg K232625 - Steriking® Pouch for Robotic Instruments K232625 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wipak OY. Cleared Jun 2024. https://www.510kdatabase.net/k232804/ 2024-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k232804-fibricheck-fda-510k.jpg K232804 - FibriCheck K232804 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Qompium NV. Cleared Jun 2024. https://www.510kdatabase.net/k232806/ 2024-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k232806-halyard-fluidshield-1-procedure-mask-fda-510k.jpg K232806 - HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867) K232806 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Owens & Minor (O&M) Halyard, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k232816/ 2024-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k232816-electrocardiograph-model-ecg301-fda-510k.jpg K232816 - Electrocardiograph, model: ECG301 K232816 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen LE Medical Technology Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k232837/ 2024-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k232837-uro-g-hd-flexible-cystoscope-fda-510k.jpg K232837 - Uro-G HD Flexible Cystoscope K232837 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Uroviu Corporation. Cleared Jun 2024. https://www.510kdatabase.net/k232963/ 2024-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k232963-vitek-2-ast-yeast-anidulafungin-0015-8-fda-510k.jpg K232963 - VITEK 2 AST-Yeast Anidulafungin (<= 0.015 - >= 8 µg/mL) K232963 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k232969/ 2024-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k232969-disposable-hemostatic-clips-fda-510k.jpg K232969 - Disposable Hemostatic Clips K232969 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ningbo Xinwell Medical Technology Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k233825/ 2024-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k233825-reprocessed-webster-duo-decapolar-fda-510k.jpg K233825 - Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter K233825 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Innovative Health. Cleared Jun 2024. https://www.510kdatabase.net/k233861/ 2024-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k233861-libre-rio-continuous-glucose-fda-510k.jpg K233861 - Libre Rio Continuous Glucose Monitoring System K233861 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Diabetes Care. Cleared Jun 2024. https://www.510kdatabase.net/k234042/ 2024-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k234042-efai-bonesuite-xr-bone-age-pro-fda-510k.jpg K234042 - EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) K234042 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ever Fortune.Ai, Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k234099/ 2024-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k234099-select-hybrid-personal-lubricant-and-fda-510k.jpg K234099 - Select Hybrid Personal Lubricant, and Select Pure Silicone Personal Lubricant K234099 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Select Labs, LLC. Cleared Jun 2024. https://www.510kdatabase.net/k240570/ 2024-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k240570-ipd-dental-implant-abutments-fda-510k.jpg K240570 - IPD Dental Implant Abutments K240570 is a FDA 510(k) cleared dental medical device. Manufacturer: Implant Protesis Dental 2004, S.L.. Cleared Jun 2024. https://www.510kdatabase.net/k240672/ 2024-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k240672-dental-zirconia-blank-dental-zirconia-fda-510k.jpg K240672 - Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ( ZD-HT-PLUS, ZD-ST, ZD-SHT, ZD-HT-C, ZD-ST-C, ZD-SHT-C, ZD-UT-C, ZD-ST-ML, ZD-SHT-ML, ZD-UT-ML, ZD-3D-Pro-ML, ZD-4D-Pro-ML) K240672 is a FDA 510(k) cleared dental medical device. Manufacturer: Zhejiang Zahndent Biotechnology Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k240832/ 2024-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k240832-blood-pressure-monitor-bbz32-aa01-fda-510k.jpg K240832 - Blood Pressure Monitor (BBZ32-AA01) K240832 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Guangdong Transtek Medical Electronics Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k240972/ 2024-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k240972-medline-renewal-reprocessed-medtronic-fda-510k.jpg K240972 - Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC) K240972 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Surgical Instrument Service and Savings, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k241038/ 2024-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k241038-cardiac-ct-function-software-application-fda-510k.jpg K241038 - Cardiac CT Function Software Application K241038 is a FDA 510(k) cleared radiology medical device. Manufacturer: Circle Cardiovascular Imaging. Cleared Jun 2024. https://www.510kdatabase.net/k241069/ 2024-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k241069-iloop-interventional-coil-055t-fda-510k.jpg K241069 - iLoop Interventional Coil 0.55T K241069 is a FDA 510(k) cleared radiology medical device. Manufacturer: Noras Mri Products GmbH. Cleared Jun 2024. https://www.510kdatabase.net/k241423/ 2024-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k241423-access-thyroglobulin-fda-510k.jpg K241423 - Access Thyroglobulin K241423 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k232774/ 2024-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k232774-wearable-breast-pumpmodel-s18-fda-510k.jpg K232774 - Wearable Breast Pump,Model S18 K232774 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ningbo Dearevery Electronic Technology Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k232968/ 2024-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k232968-grande-medical-masks-model-sf-600-fda-510k.jpg K232968 - Grande Medical Masks, Model SF-600 K232968 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Golden Grande Corp.. Cleared Jun 2024. https://www.510kdatabase.net/k233094/ 2024-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k233094-wellead-latex-foley-catheter-fda-510k.jpg K233094 - Wellead® Latex Foley Catheter K233094 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Well Lead Medical (Hainan) Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k233824/ 2024-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k233824-swan-ganz-catheter-fda-510k.jpg K233824 - Swan-Ganz catheter K233824 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Jun 2024. https://www.510kdatabase.net/k240202/ 2024-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k240202-conical-platform-dental-implants-system-fda-510k.jpg K240202 - Conical Platform Dental Implants System K240202 is a FDA 510(k) cleared dental medical device. Manufacturer: Noris Medical , Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k240657/ 2024-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k240657-artisential-laparoscopic-instruments-fda-510k.jpg K240657 - ArtiSential Laparoscopic Instruments-Electrodes (AMHD01-LH) K240657 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Livsmed, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k240662/ 2024-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k240662-spine-guidance-software-version-50-fda-510k.jpg K240662 - Spine Guidance Software (version 5.0) K240662 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Leibinger GmbH & Co KG. Cleared Jun 2024. https://www.510kdatabase.net/k240948/ 2024-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k240948-tracstar-ldp-large-distal-platform-fda-510k.jpg K240948 - TracStar LDP Large Distal Platform K240948 is a FDA 510(k) cleared neurology medical device. Manufacturer: Imperative Care, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k240951/ 2024-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k240951-invictus-robotic-navigation-instruments-fda-510k.jpg K240951 - Invictus Robotic Navigation Instruments K240951 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine. Cleared Jun 2024. https://www.510kdatabase.net/k240963/ 2024-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k240963-spinal-system-fda-510k.jpg K240963 - Spinal System K240963 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Teslake, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k240965/ 2024-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k240965-cortrak-2-enteral-access-system-20-0950-fda-510k.jpg K240965 - CORTRAK* 2 Enteral Access System (20-0950) K240965 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Avanos Medical, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k241304/ 2024-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k241304-wavesense-jazz-blood-glucose-fda-510k.jpg K241304 - WaveSense Jazz Blood Glucose Monitoring System K241304 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Agamatrix. Cleared Jun 2024. https://www.510kdatabase.net/k233008/ 2024-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k233008-cannulated-headless-bone-screws-fda-510k.jpg K233008 - Cannulated Headless Bone Screws K233008 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aap Implantate AG. Cleared Jun 2024. https://www.510kdatabase.net/k240008/ 2024-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k240008-mobility-scooter-w3331-fda-510k.jpg K240008 - Mobility Scooter (W3331) K240008 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zhejiang Innuovo Rehabilitation Devices Co.,Ltd. Cleared Jun 2024. https://www.510kdatabase.net/k240187/ 2024-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k240187-tapered-pro-conical-implant-system-fda-510k.jpg K240187 - Tapered Pro Conical Implant System K240187 is a FDA 510(k) cleared dental medical device. Manufacturer: BioHorizons Implant Systems, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k240211/ 2024-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k240211-velys-robotic-assisted-solution-fda-510k.jpg K240211 - VELYS Robotic-Assisted Solution K240211 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Ireland UC. Cleared Jun 2024. https://www.510kdatabase.net/k240358/ 2024-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k240358-shockphysio-mobile-model-sw3200-basic-fda-510k.jpg K240358 - ShockPhysio Mobile (model SW3200 Basic) K240358 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Shenzhen Dongdixin Technology Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k240603/ 2024-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k240603-ti-base-master-fix-fda-510k.jpg K240603 - Ti-Base & Master Fix K240603 is a FDA 510(k) cleared dental medical device. Manufacturer: Arum Dentistry Co., Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k240648/ 2024-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k240648-non-contact-forehead-thermomete-th48fe-fda-510k.jpg K240648 - Non-contact Forehead Thermomete (TH48FE, TH09F, THD2FE) K240648 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Radiant Innovation, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k241262/ 2024-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k241262-baby-gorillagorilla-plating-system-fda-510k.jpg K241262 - Baby Gorilla/Gorilla Plating System K241262 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paragon 28, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k232773/ 2024-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k232773-da-vinci-sp-surgical-system-sp1098-fda-510k.jpg K232773 - da Vinci SP Surgical System (SP1098) K232773 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k232820/ 2024-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k232820-halyard-fluidshield-1-fog-free-fda-510k.jpg K232820 - HALYARD* FLUIDSHIELD* 1 Fog-Free Surgical Mask with So Soft Lining (28806) K232820 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Owens & Minor (O&M) Halyard, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k233971/ 2024-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k233971-arthrex-allosync-pushlock-suture-anchor-fda-510k.jpg K233971 - Arthrex AlloSync PushLock Suture Anchor K233971 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k234032/ 2024-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k234032-hudson-rci-dri-tech-breathing-circuits-fda-510k.jpg K234032 - Hudson RCI Dri-Tech Breathing Circuits K234032 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Medline Industries, LP. Cleared Jun 2024. https://www.510kdatabase.net/k240100/ 2024-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k240100-sam-model-9-10000-fda-510k.jpg K240100 - SAM Model 9-10000 K240100 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Snap Diagnostics, LLC. Cleared Jun 2024. https://www.510kdatabase.net/k240222/ 2024-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k240222-dermalux-tri-wave-md-mkii-1000021-fda-510k.jpg K240222 - Dermalux Tri-Wave MD MKII (1000021) K240222 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesthetic Technology, Ltd.. Cleared Jun 2024. https://www.510kdatabase.net/k240463/ 2024-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k240463-slow-wave-ds8-swds802-fda-510k.jpg K240463 - Slow Wave DS8 (SWDS802) K240463 is a FDA 510(k) cleared dental medical device. Manufacturer: Slow Wave, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k240505/ 2024-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k240505-eminent-spine-si-screw-system-fda-510k.jpg K240505 - Eminent Spine SI Screw System K240505 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Eminent Spine, LLC. Cleared Jun 2024. https://www.510kdatabase.net/k240627/ 2024-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k240627-liaison-plex-yeast-blood-culture-assay-fda-510k.jpg K240627 - LIAISON PLEX Yeast Blood Culture Assay K240627 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Luminex Corporation. Cleared Jun 2024. https://www.510kdatabase.net/k240877/ 2024-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k240877-monteris-medical-neuroblate-system-fda-510k.jpg K240877 - Monteris Medical NeuroBlate System K240877 is a FDA 510(k) cleared neurology medical device. Manufacturer: Monteris Medical,. Cleared Jun 2024. https://www.510kdatabase.net/k241258/ 2024-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k241258-ingenix-spinal-system-fda-510k.jpg K241258 - Ingenix Spinal System K241258 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ingenium Spine. Cleared Jun 2024. https://www.510kdatabase.net/k231291/ 2024-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k231291-perforated-baskets-fda-510k.jpg K231291 - Perforated Baskets K231291 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Richard Wolf Medical Instruments Corporation. Cleared Jun 2024. https://www.510kdatabase.net/k233587/ 2024-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k233587-locator-angled-abutment-various-fda-510k.jpg K233587 - LOCATOR Angled Abutment (Various) K233587 is a FDA 510(k) cleared dental medical device. Manufacturer: Zest Anchors, LLC. Cleared Jun 2024. https://www.510kdatabase.net/k233751/ 2024-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k233751-milieve-yps-301bd-fda-510k.jpg K233751 - Milieve (YPS-301BD) K233751 is a FDA 510(k) cleared neurology medical device. Manufacturer: Soterix Medical, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k240251/ 2024-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k240251-anne-chest-fda-510k.jpg K240251 - ANNE Chest K240251 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sibel Health, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k240598/ 2024-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k240598-maestro-system-ref100-fda-510k.jpg K240598 - Maestro System (REF100) K240598 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Moon Surgical. Cleared Jun 2024. https://www.510kdatabase.net/k240617/ 2024-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k240617-single-use-reloadable-clip-applicator-fda-510k.jpg K240617 - Single Use Reloadable Clip Applicator (HX-810LR, HX-810UR) K240617 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Jun 2024. https://www.510kdatabase.net/k240834/ 2024-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k240834-ecofit-short-stem-cementless-cpti-fda-510k.jpg K240834 - EcoFit® short stem cementless cpTi K240834 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Implantcast GmbH. Cleared Jun 2024. https://www.510kdatabase.net/k240947/ 2024-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k240947-tensor-suture-button-system-fda-510k.jpg K240947 - TENSOR® Suture Button System K240947 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k241259/ 2024-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k241259-amplatz-goose-neck-snare-kit-fda-510k.jpg K241259 - Amplatz Goose Neck Snare Kit K241259 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Jun 2024. https://www.510kdatabase.net/k220062/ 2024-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k220062-qiastat-dx-gastrointestinal-panel-2-fda-510k.jpg K220062 - QIAstat-Dx Gastrointestinal Panel 2 K220062 is a FDA 510(k) cleared microbiology medical device. Manufacturer: QIAGEN GmbH. Cleared May 2024. https://www.510kdatabase.net/k222196/ 2024-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k222196-deep-tms-system-fda-510k.jpg K222196 - Deep TMS System K222196 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainsway , Ltd.. Cleared May 2024. https://www.510kdatabase.net/k223427/ 2024-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k223427-mimics-enlight-cmf-fda-510k.jpg K223427 - Mimics Enlight CMF K223427 is a FDA 510(k) cleared dental medical device. Manufacturer: Materialise NV. Cleared May 2024. https://www.510kdatabase.net/k231151/ 2024-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k231151-kenota-1-total-ige-fda-510k.jpg K231151 - Kenota 1 Total IgE K231151 is a FDA 510(k) cleared immunology medical device. Manufacturer: Kenota, Inc.. Cleared May 2024. https://www.510kdatabase.net/k232080/ 2024-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k232080-puracyn-plus-antimicrobial-irrigation-fda-510k.jpg K232080 - Puracyn® Plus Antimicrobial Irrigation Solution K232080 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Innovacyn, Inc.. Cleared May 2024. https://www.510kdatabase.net/k232107/ 2024-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k232107-m-warmer-system-fda-510k.jpg K232107 - °M Warmer System K232107 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Mequ A/S. Cleared May 2024. https://www.510kdatabase.net/k232333/ 2024-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k232333-anti-bacterial-bandage-fda-510k.jpg K232333 - Anti-bacterial bandage K232333 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Jinhua Jingdi Medical Supplies Co., Ltd.. Cleared May 2024. https://www.510kdatabase.net/k232601/ 2024-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k232601-bronctru-transbronchial-access-tool-fda-510k.jpg K232601 - BroncTru™ Transbronchial Access Tool K232601 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Broncus Medical, Inc.. Cleared May 2024. https://www.510kdatabase.net/k232715/ 2024-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k232715-distinct-digital-pregnancy-test-fda-510k.jpg K232715 - Distinct® Digital Pregnancy Test K232715 is a FDA 510(k) cleared chemistry medical device. Manufacturer: ACON Laboratories, Inc.. Cleared May 2024. https://www.510kdatabase.net/k232738/ 2024-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k232738-beamdose-software-s080053-fda-510k.jpg K232738 - BeamDose software (S080053) K232738 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla. Cleared May 2024. https://www.510kdatabase.net/k232821/ 2024-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k232821-sin-dental-implant-system-fda-510k.jpg K232821 - S.I.N. Dental Implant System K232821 is a FDA 510(k) cleared dental medical device. Manufacturer: S.I.N. ? Sistema DE Implante Nacional S.A.. Cleared May 2024. https://www.510kdatabase.net/k232943/ 2024-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k232943-hypodermic-needle-pro-edge-safety-fda-510k.jpg K232943 - Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Space Syringe K232943 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Smiths Medical Asd, Inc.. Cleared May 2024. https://www.510kdatabase.net/k233295/ 2024-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k233295-lfr-260-fda-510k.jpg K233295 - LFR-260 K233295 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Evolution Optiks Limited. Cleared May 2024. https://www.510kdatabase.net/k233591/ 2024-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k233591-stylus-fda-510k.jpg K233591 - Stylus K233591 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Degania Silicone , Ltd.. Cleared May 2024. https://www.510kdatabase.net/k233729/ 2024-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k233729-ringer-perfusion-balloon-catheter-200-fda-510k.jpg K233729 - Ringer perfusion balloon catheter, 2.00 x 20mm (5881) K233729 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vascular Solutions, LLC. Cleared May 2024. https://www.510kdatabase.net/k233842/ 2024-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k233842-ihealth-covid-19-antigen-rapid-test-fda-510k.jpg K233842 - iHealth COVID-19 Antigen Rapid Test K233842 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Ihealth Labs, Inc.. Cleared May 2024. https://www.510kdatabase.net/k240254/ 2024-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k240254-blood-pressure-monitor-tmb-2296-bt-fda-510k.jpg K240254 - Blood Pressure Monitor (TMB-2296-BT) K240254 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Guangdong Transtek Medical Electronics Co., Ltd.. Cleared May 2024. https://www.510kdatabase.net/k240281/ 2024-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k240281-bone-suppression-software-fda-510k.jpg K240281 - Bone Suppression Software K240281 is a FDA 510(k) cleared radiology medical device. Manufacturer: Konica Minolta, Inc.. Cleared May 2024. https://www.510kdatabase.net/k240394/ 2024-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k240394-multiflux-1000-f00012408-fda-510k.jpg K240394 - multiFlux 1000 (F00012408) K240394 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC. Cleared May 2024. https://www.510kdatabase.net/k240612/ 2024-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k240612-cina-vcf-fda-510k.jpg K240612 - CINA-VCF K240612 is a FDA 510(k) cleared radiology medical device. Manufacturer: Avicenna.Ai. Cleared May 2024. https://www.510kdatabase.net/k240912/ 2024-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k240912-dental-zirconia-block-models-ht-plus-fda-510k.jpg K240912 - Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro) K240912 is a FDA 510(k) cleared dental medical device. Manufacturer: Anhui Miisen Intelligence Technology Co., Ltd.. Cleared May 2024. https://www.510kdatabase.net/k240913/ 2024-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k240913-electric-wheelchair-hbld3-b-fda-510k.jpg K240913 - Electric Wheelchair (HBLD3-B) K240913 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Shanghai Hubang Intelligent Rehabilitation Equipment Co.,Ltd. Cleared May 2024. https://www.510kdatabase.net/k240969/ 2024-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k240969-ipl-hair-removal-sl-b287-sl-b329-sl-fda-510k.jpg K240969 - IPL Hair Removal (SL-B287, SL-B329, SL-B301-1, SL-B328) K240969 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Semlamp Intelligent Technology Co., Ltd.. Cleared May 2024. https://www.510kdatabase.net/k241055/ 2024-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k241055-electro-lube-nxt-fda-510k.jpg K241055 - Electro Lube NXT K241055 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Steris. Cleared May 2024. https://www.510kdatabase.net/k241218/ 2024-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k241218-tyber-medical-anatomical-plating-system-fda-510k.jpg K241218 - Tyber Medical Anatomical Plating System K241218 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tyber Medical, LLC. Cleared May 2024. https://www.510kdatabase.net/k241226/ 2024-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k241226-fixtemp-cb-41-fda-510k.jpg K241226 - Fixtemp® C&B 4:1 K241226 is a FDA 510(k) cleared dental medical device. Manufacturer: Dreve Denatmid GmbH. Cleared May 2024. https://www.510kdatabase.net/k241248/ 2024-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k241248-quantum-perfusion-dual-lumen-cannula-fda-510k.jpg K241248 - Quantum Perfusion Dual Lumen Cannula 31F-V1 (DL31F-V1) K241248 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Spectrum Medical S.R.L.. Cleared May 2024. https://www.510kdatabase.net/k232505/ 2024-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k232505-endovenous-radiofrequency-generator-fda-510k.jpg K232505 - Endovenous Radiofrequency Generator, Endovenous Radiofrequency Catheter K232505 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Zhejiang Curaway Medical Technology Co., Ltd.. Cleared May 2024. https://www.510kdatabase.net/k232934/ 2024-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k232934-sunsphere-fda-510k.jpg K232934 - Sunsphere K232934 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Hangzhou Yangshun Medical Technology Co.,Ltd. Cleared May 2024. https://www.510kdatabase.net/k233025/ 2024-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k233025-revolution-external-plating-system-fda-510k.jpg K233025 - Revolution External Plating System K233025 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: New Standard Device Dba Metalogix. Cleared May 2024. https://www.510kdatabase.net/k233126/ 2024-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k233126-aetherslide-fda-510k.jpg K233126 - aetherSlide K233126 is a FDA 510(k) cleared pathology medical device. Manufacturer: Aetherai Co., Ltd.. Cleared May 2024. https://www.510kdatabase.net/k233674/ 2024-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k233674-freedom-wrist-arthroplasty-system-fda-510k.jpg K233674 - Freedom Wrist Arthroplasty System K233674 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ascension Orthopedics, Inc.. Cleared May 2024. https://www.510kdatabase.net/k234003/ 2024-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k234003-the-circadia-c200-system-fda-510k.jpg K234003 - The Circadia C200 System K234003 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Circadia Technologies, Ltd.. Cleared May 2024. https://www.510kdatabase.net/k240687/ 2024-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k240687-sofwave-system-fda-510k.jpg K240687 - SofWave System K240687 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sofwave Medical, Ltd.. Cleared May 2024. https://www.510kdatabase.net/k240838/ 2024-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k240838-spectrum-spine-cervical-cage-system-fda-510k.jpg K240838 - Spectrum Spine Cervical Cage System K240838 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spectrum Spine, Inc.. Cleared May 2024. https://www.510kdatabase.net/k241194/ 2024-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k241194-biofire-spotfire-respiratorysore-fda-510k.jpg K241194 - BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel Mini K241194 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Biofire Diagnostics, LLC. Cleared May 2024. https://www.510kdatabase.net/k241289/ 2024-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k241289-spotfire-rsp-pos-neg-controls-fda-510k.jpg K241289 - SPOTFIRE RSP Pos & Neg Controls K241289 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Maine Molecular Quality Controls, Inc.. Cleared May 2024. https://www.510kdatabase.net/k232672/ 2024-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k232672-easyscreen-gastrointestinal-parasite-fda-510k.jpg K232672 - EasyScreen Gastrointestinal Parasite Detection Kit K232672 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Genetic Signatures Limited. Cleared May 2024. https://www.510kdatabase.net/k232741/ 2024-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k232741-smartadjusttm-technology-fda-510k.jpg K232741 - SmartAdjust(TM) technology K232741 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Insulet Corporation. Cleared May 2024. https://www.510kdatabase.net/k233166/ 2024-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k233166-net-recovery-corpnet-device-fda-510k.jpg K233166 - NET Recovery Corp/NET Device K233166 is a FDA 510(k) cleared neurology medical device. Manufacturer: Net Recovery. Cleared May 2024. https://www.510kdatabase.net/k233389/ 2024-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k233389-ek-digital-abutments-fda-510k.jpg K233389 - EK Digital Abutments K233389 is a FDA 510(k) cleared dental medical device. Manufacturer: Hiossen, Inc.. Cleared May 2024. https://www.510kdatabase.net/k233481/ 2024-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k233481-altivate-reverse-glenoid-fda-510k.jpg K233481 - AltiVate Reverse® Glenoid K233481 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Encore Medical, L.P.. Cleared May 2024. https://www.510kdatabase.net/k233655/ 2024-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k233655-lingo-glucose-system-fda-510k.jpg K233655 - Lingo Glucose System K233655 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott. Cleared May 2024. https://www.510kdatabase.net/k240049/ 2024-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k240049-linktm-external-fixator-fda-510k.jpg K240049 - LINK(TM) External Fixator K240049 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Metric Medical Devices, Inc.. Cleared May 2024. https://www.510kdatabase.net/k240159/ 2024-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k240159-innovoyce-vylo-fda-510k.jpg K240159 - InnoVoyce VYLO K240159 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Innovoyce. Cleared May 2024. https://www.510kdatabase.net/k240784/ 2024-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k240784-temperature-sensor-probe-abl-18tp20-fda-510k.jpg K240784 - Temperature Sensor Probe (ABL-18TP20) K240784 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared May 2024. https://www.510kdatabase.net/k241190/ 2024-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k241190-plpt-ldvlow-dead-volume-lcluer-cone-fda-510k.jpg K241190 - PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe K241190 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Poonglim Pharmatech, Inc.. Cleared May 2024. https://www.510kdatabase.net/k241207/ 2024-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k241207-smartclaw-thrombectomy-catheter-20-mm-fda-510k.jpg K241207 - SmartClaw™ Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw™ Thrombectomy Catheter, 32 mm (FD0660-02) K241207 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Devoro Medical, Inc.. Cleared May 2024. https://www.510kdatabase.net/k241235/ 2024-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k241235-arthrex-tightrope-ii-fda-510k.jpg K241235 - Arthrex TightRope II K241235 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared May 2024. https://www.510kdatabase.net/k223629/ 2024-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k223629-spirosphere-spirosphereecg-cardiosphere-fda-510k.jpg K223629 - SpiroSphere, SpiroSphereECG, CardioSphere K223629 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Eresearchtechnology GmbH. Cleared May 2024. https://www.510kdatabase.net/k233076/ 2024-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k233076-laser-speckle-imaging-system-rflsi-czw-fda-510k.jpg K233076 - Laser Speckle Imaging System (RFLSI CZW) K233076 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Rwd Life Science Co., Ltd.. Cleared May 2024. https://www.510kdatabase.net/k233344/ 2024-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k233344-regenalase-laser-system-fda-510k.jpg K233344 - Regenalase Laser System K233344 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ipg Medical. Cleared May 2024. https://www.510kdatabase.net/k240304/ 2024-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k240304-injectable-root-canal-bioceramic-fda-510k.jpg K240304 - Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5) K240304 is a FDA 510(k) cleared dental medical device. Manufacturer: Enpuno Biotechnology Co., Ltd.. Cleared May 2024. https://www.510kdatabase.net/k240305/ 2024-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k240305-anne-limb-fda-510k.jpg K240305 - ANNE Limb K240305 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sibel Health, Inc.. Cleared May 2024. https://www.510kdatabase.net/k240410/ 2024-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k240410-evolve-nitric-oxide-delivery-system-fda-510k.jpg K240410 - EVOLVE Nitric Oxide Delivery System K240410 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Malinckrodt Manufacturing, LLC. Cleared May 2024. https://www.510kdatabase.net/k240629/ 2024-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k240629-nitrile-disposable-examination-gloves-fda-510k.jpg K240629 - Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl K240629 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Xingyu Medical Tech Co., Ltd.. Cleared May 2024. https://www.510kdatabase.net/k240749/ 2024-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k240749-pillar-sa-ti-spacer-system-82-xxx-fda-510k.jpg K240749 - PILLAR SA Ti Spacer System (82-XXX) K240749 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthofix, Inc.. Cleared May 2024. https://www.510kdatabase.net/k240874/ 2024-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k240874-luna-diode-laser-system-tl-s20s-twc-tl-fda-510k.jpg K240874 - Luna Diode Laser System (TL-S20S-TWC, TL-S20S-755A , TL-S20S-810B) K240874 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Theralaser Medtech (China) Co., Ltd.. Cleared May 2024. https://www.510kdatabase.net/k241177/ 2024-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k241177-react-71-catheter-fda-510k.jpg K241177 - React 71 Catheter K241177 is a FDA 510(k) cleared neurology medical device. Manufacturer: Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular. Cleared May 2024. https://www.510kdatabase.net/k231426/ 2024-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k231426-8plant-implant-system-fda-510k.jpg K231426 - 8plant Implant System K231426 is a FDA 510(k) cleared dental medical device. Manufacturer: Hoowon Edi Co., Ltd.. Cleared May 2024. https://www.510kdatabase.net/k231939/ 2024-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k231939-renasys-edge-fda-510k.jpg K231939 - Renasys Edge K231939 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew Medical, Ltd.. Cleared May 2024. https://www.510kdatabase.net/k232632/ 2024-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k232632-racz-neurostat-rf-generator-fda-510k.jpg K232632 - Racz Neurostat RF Generator K232632 is a FDA 510(k) cleared neurology medical device. Manufacturer: Epimed International. Cleared May 2024. https://www.510kdatabase.net/k232639/ 2024-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k232639-apollo-tms-therapy-system-fda-510k.jpg K232639 - Apollo TMS Therapy System K232639 is a FDA 510(k) cleared neurology medical device. Manufacturer: Mag & More GmbH. Cleared May 2024. https://www.510kdatabase.net/k232646/ 2024-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k232646-biodesign-otologic-butterfly-graft-ent-fda-510k.jpg K232646 - Biodesign Otologic Butterfly Graft (ENT-OTO-BFLY-0.4-0.6) K232646 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Cook Biotech Incorporated. Cleared May 2024. https://www.510kdatabase.net/k232788/ 2024-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k232788-inspira-art100-fda-510k.jpg K232788 - INSPIRA ART100 K232788 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inspira Technologies Oxy B.H.N. , Ltd.. Cleared May 2024. https://www.510kdatabase.net/k233089/ 2024-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k233089-neospan-compression-implant-system-fda-510k.jpg K233089 - NeoSpan® Compression Implant System K233089 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: In2bones USA, LLC. Cleared May 2024. https://www.510kdatabase.net/k233111/ 2024-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k233111-algs2-ag-alginate-wound-dressing-rx-fda-510k.jpg K233111 - ALGS2 Ag Alginate Wound Dressing Rx K233111 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Foshan United Medical Technologies, Ltd.. Cleared May 2024. https://www.510kdatabase.net/k233285/ 2024-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k233285-katana-zirconia-one-for-implant-fda-510k.jpg K233285 - KATANA Zirconia ONE For IMPLANT K233285 is a FDA 510(k) cleared dental medical device. Manufacturer: Kuraray Noritake Dental, Inc.. Cleared May 2024. https://www.510kdatabase.net/k233386/ 2024-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k233386-monik-disposable-endoscopic-trocar-fda-510k.jpg K233386 - Monik™ - Disposable Endoscopic Trocar K233386 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: M/s. Meril Endo Surgery Private Limited.. Cleared May 2024. https://www.510kdatabase.net/k233777/ 2024-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k233777-primed-sterilization-wrap-p100-p200-fda-510k.jpg K233777 - PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) K233777 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Primed Medical Products, Inc.. Cleared May 2024. https://www.510kdatabase.net/k234154/ 2024-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k234154-upmr-790-fda-510k.jpg K234154 - uPMR 790 K234154 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared May 2024. https://www.510kdatabase.net/k240592/ 2024-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k240592-wolffs-law-anterior-cervical-plate-fda-510k.jpg K240592 - Wolff's Law Anterior Cervical Plate System K240592 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinal Simplicity, LLC. Cleared May 2024. https://www.510kdatabase.net/k240723/ 2024-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k240723-da-vinci-xi-surgical-system-is4000-fda-510k.jpg K240723 - da Vinci Xi Surgical System (IS4000) K240723 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical. Cleared May 2024. https://www.510kdatabase.net/k240769/ 2024-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k240769-lvivo-iqs-fda-510k.jpg K240769 - LVivo IQS K240769 is a FDA 510(k) cleared radiology medical device. Manufacturer: Dia Imaging Analysis, Ltd.. Cleared May 2024. https://www.510kdatabase.net/k240810/ 2024-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k240810-anti-grinding-guard-fda-510k.jpg K240810 - Anti Grinding Guard K240810 is a FDA 510(k) cleared dental medical device. Manufacturer: Xiamen Yizhou Imp. & Exp. Co., Ltd.. Cleared May 2024. https://www.510kdatabase.net/k240827/ 2024-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k240827-set-5002-fda-510k.jpg K240827 - SET-5002 K240827 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shimadzu Corporation Medical Systems Division. Cleared May 2024. https://www.510kdatabase.net/k240864/ 2024-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k240864-pacepro-wire-fda-510k.jpg K240864 - PacePro Wire K240864 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Opsens, Inc.. Cleared May 2024. https://www.510kdatabase.net/k241178/ 2024-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k241178-deka-ace-pump-system-fda-510k.jpg K241178 - DEKA ACE Pump System K241178 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Deka Research and Development. Cleared May 2024. https://www.510kdatabase.net/k232602/ 2024-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k232602-3dmatrix-surgical-mesh-fda-510k.jpg K232602 - 3DMatrix Surgical Mesh K232602 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Printbio, Inc.. Cleared May 2024. https://www.510kdatabase.net/k232603/ 2024-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k232603-camaps-fx-fda-510k.jpg K232603 - CamAPS FX K232603 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Camdiab , Ltd.. Cleared May 2024. https://www.510kdatabase.net/k232642/ 2024-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k232642-airkee-t900-fda-510k.jpg K232642 - AirKEE T900 K232642 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Healkee Medical Pte, Ltd.. Cleared May 2024. https://www.510kdatabase.net/k233108/ 2024-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k233108-vindr-mammo-fda-510k.jpg K233108 - VinDr-Mammo K233108 is a FDA 510(k) cleared radiology medical device. Manufacturer: Vinbigdata Joint Stock Company. Cleared May 2024. https://www.510kdatabase.net/k233120/ 2024-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k233120-cwm-930s-fixer-dv9-fda-510k.jpg K233120 - CWM-930S, FIXER DV9 K233120 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Chungwoo Co., Ltd.. Cleared May 2024. https://www.510kdatabase.net/k233251/ 2024-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k233251-noxboxi-nitric-oxide-delivery-system-fda-510k.jpg K233251 - NOxBOXi Nitric Oxide Delivery System K233251 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Linde Gas & Equipment, Inc.. Cleared May 2024. https://www.510kdatabase.net/k233868/ 2024-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k233868-dima-print-teeth-temp-fda-510k.jpg K233868 - dima Print Teeth & Temp K233868 is a FDA 510(k) cleared dental medical device. Manufacturer: Kulzer, LLC. Cleared May 2024. https://www.510kdatabase.net/k240294/ 2024-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k240294-syngo-carbon-enterprise-access-va40a-fda-510k.jpg K240294 - Syngo Carbon Enterprise Access (VA40A) K240294 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Healthcare GmbH. Cleared May 2024. https://www.510kdatabase.net/k240701/ 2024-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k240701-drill-guide-fda-510k.jpg K240701 - Drill Guide K240701 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Brainlab AG. Cleared May 2024. https://www.510kdatabase.net/k241134/ 2024-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k241134-3m-activac-canister-300ml-with-gel-fda-510k.jpg K241134 - 3M™ ActiV.A.C.™ Canister - 300ml with Gel (M8275058/5, M8275058/10) K241134 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Kci USA, Inc.. Cleared May 2024. https://www.510kdatabase.net/k241396/ 2024-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k241396-ucerv-flux-c-3d-porous-titanium-fda-510k.jpg K241396 - uCerv Flux™-C 3D Porous Titanium Cervical Interbody K241396 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ulrich Medical USA, Inc.. Cleared May 2024. https://www.510kdatabase.net/k232655/ 2024-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k232655-bonvadis-fda-510k.jpg K232655 - Bonvadis® K232655 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stemcyte, Inc.. Cleared May 2024. https://www.510kdatabase.net/k232740/ 2024-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k232740-paltop-short-implants-fda-510k.jpg K232740 - Paltop Short Implants K232740 is a FDA 510(k) cleared dental medical device. Manufacturer: Paltop Advanced Dental Solutions, Ltd.. Cleared May 2024. https://www.510kdatabase.net/k233099/ 2024-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k233099-gladiator-fda-510k.jpg K233099 - Gladiator K233099 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Rohrer Aesthetics, LLC. Cleared May 2024. https://www.510kdatabase.net/k233268/ 2024-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k233268-impress-angiographic-catheter-fda-510k.jpg K233268 - Impress Angiographic Catheter K233268 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared May 2024. https://www.510kdatabase.net/k233819/ 2024-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k233819-fogarty-venous-thrombectomy-catheters-fda-510k.jpg K233819 - Fogarty Venous Thrombectomy Catheters K233819 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared May 2024. https://www.510kdatabase.net/k233820/ 2024-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k233820-fogarty-arterial-embolectomy-catheter-fda-510k.jpg K233820 - Fogarty Arterial Embolectomy Catheter with Gate Valve K233820 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences. Cleared May 2024. https://www.510kdatabase.net/k233884/ 2024-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k233884-inumi-flex-needle-fda-510k.jpg K233884 - INUMI™ Flex Needle K233884 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Galvanize Therapeutics, Inc.. Cleared May 2024. https://www.510kdatabase.net/k240097/ 2024-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k240097-polysaccharide-hemostatic-powder-hp-2-fda-510k.jpg K240097 - Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5) K240097 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ushare Medical, Inc.. Cleared May 2024. https://www.510kdatabase.net/k240199/ 2024-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k240199-intraop-alignment-system-fda-510k.jpg K240199 - IntraOp Alignment System K240199 is a FDA 510(k) cleared radiology medical device. Manufacturer: Alphatec Spine, Inc.. Cleared May 2024. https://www.510kdatabase.net/k240224/ 2024-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k240224-zenition-90-fda-510k.jpg K240224 - Zenition 90 K240224 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederlands B.V.. Cleared May 2024. https://www.510kdatabase.net/k240456/ 2024-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k240456-bosley-booster-128-laser-cap-fda-510k.jpg K240456 - Bosley Booster 128 Laser Cap K240456 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Plm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC. Cleared May 2024. https://www.510kdatabase.net/k241014/ 2024-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k241014-biomet-kirschner-wires-k-wires-fda-510k.jpg K241014 - Biomet Kirschner Wires (K-Wires) K241014 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared May 2024. https://www.510kdatabase.net/k241100/ 2024-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k241100-rapid-urine-fentanyl-fyl-test-strip-fda-510k.jpg K241100 - Rapid Urine Fentanyl (FYL) Test Strip K241100 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Co-Innovation Biotech Co., Ltd.. Cleared May 2024. https://www.510kdatabase.net/k241106/ 2024-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k241106-ice-cooling-ipl-home-use-hair-removal-fda-510k.jpg K241106 - Ice Cooling IPL Home Use Hair Removal Device (Model(s): T10B, T10C, T15A, T17A, T18A, T14A, T16A, T19A) K241106 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Mlay Intelligent Technology Co., Ltd.. Cleared May 2024. https://www.510kdatabase.net/k241126/ 2024-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k241126-ovitex-prs-fda-510k.jpg K241126 - OviTex PRS K241126 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: TELA Bio, Inc.. Cleared May 2024. https://www.510kdatabase.net/k241143/ 2024-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k241143-materialise-shoulder-system-fda-510k.jpg K241143 - Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner K241143 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Materialise NV. Cleared May 2024. https://www.510kdatabase.net/k232677/ 2024-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k232677-reia-pessary-fda-510k.jpg K232677 - Reia pessary K232677 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Reia, LLC. Cleared May 2024. https://www.510kdatabase.net/k232759/ 2024-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k232759-viewer-54-fda-510k.jpg K232759 - Viewer (5.4) K232759 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab AG. Cleared May 2024. https://www.510kdatabase.net/k232946/ 2024-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k232946-yumizen-h2500-fda-510k.jpg K232946 - Yumizen H2500 K232946 is a FDA 510(k) cleared hematology medical device. Manufacturer: HORIBA ABX SAS. Cleared May 2024. https://www.510kdatabase.net/k233336/ 2024-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k233336-213-3mp-color-lcd-display-umd3-21b01-fda-510k.jpg K233336 - 21.3” 3MP Color LCD Display UMD3-21B01 (MD3-21B01) K233336 is a FDA 510(k) cleared radiology medical device. Manufacturer: Acula Technology Corp.. Cleared May 2024. https://www.510kdatabase.net/k233442/ 2024-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k233442-trocarwash-system-fda-510k.jpg K233442 - troCarWash™ System K233442 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Biotex, Inc.. Cleared May 2024. https://www.510kdatabase.net/k233543/ 2024-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k233543-ysio-xpree-fda-510k.jpg K233543 - YSIO X.pree K233543 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions. Cleared May 2024. https://www.510kdatabase.net/k240433/ 2024-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k240433-proseal-injection-site-extended-male-fda-510k.jpg K240433 - ProSeal™ Injection Site Extended Male Luer Lock (422140) K240433 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Epic Medical Pte. , Ltd.. Cleared May 2024. https://www.510kdatabase.net/k240806/ 2024-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k240806-safety-lancet-xxviii-xxix-xxx-xxxi-fda-510k.jpg K240806 - Safety lancet (XXVIII, XXIX, XXX, XXXI, XXXII, XXXIII, XXXIV.) K240806 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Tianjin Huahong Technology Co., Ltd.. Cleared May 2024. https://www.510kdatabase.net/k241110/ 2024-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k241110-cdc-human-influenza-virus-real-time-rt-fda-510k.jpg K241110 - CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit (Ver4) K241110 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Centers For Disease Control and Prevention. Cleared May 2024. https://www.510kdatabase.net/den230068/ 2024-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/den230068-3m-attest-ebowie-dick-test-card-10135-fda-510k.jpg DEN230068 - 3M™ Attest™ eBowie-Dick Test Card 10135 3M™ Attest™ eBowie-Dick Card Holder 10135CH 3M™ Attest™ eBowie-Dick Auto-reader 1190 DEN230068 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared May 2024. https://www.510kdatabase.net/k223399/ 2024-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k223399-avita-pulse-oximeter-fda-510k.jpg K223399 - AViTA Pulse Oximeter K223399 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Avita Corporation. Cleared May 2024. https://www.510kdatabase.net/k232702/ 2024-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k232702-solo-tympanostomy-tube-device-ttd-fda-510k.jpg K232702 - Solo+ Tympanostomy Tube Device (TTD) K232702 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Aventamed Dac. Cleared May 2024. https://www.510kdatabase.net/k233341/ 2024-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k233341-shiley-oralnasal-endotracheal-tube-fda-510k.jpg K233341 - Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP (87430, 87435, 87440, 87445, 87450, 87455, 87460, 87465, 87470, 87475, 87480, 87485, 87490, 87495, 87410) K233341 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Covidien, LLC. Cleared May 2024. https://www.510kdatabase.net/k233619/ 2024-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k233619-fogarty-corkscrew-catheters-fda-510k.jpg K233619 - Fogarty Corkscrew Catheters K233619 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences. Cleared May 2024. https://www.510kdatabase.net/k233620/ 2024-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k233620-mim-centiloid-scaling-fda-510k.jpg K233620 - MIM - Centiloid Scaling K233620 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mim Software, Inc.. Cleared May 2024. https://www.510kdatabase.net/k240474/ 2024-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k240474-multi-function-platform-systems-bl-m10-fda-510k.jpg K240474 - Multi-function Platform Systems (BL-M10) K240474 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shanghai Bele Medical Technology Co.,Ltd. Cleared May 2024. https://www.510kdatabase.net/k240511/ 2024-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k240511-dentis-s-clean-sq-sl-fixture-fda-510k.jpg K240511 - Dentis s-Clean SQ-SL Fixture K240511 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentis Co., Ltd.. Cleared May 2024. https://www.510kdatabase.net/k240520/ 2024-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k240520-diode-laser-hair-removal-system-sh-vd910-fda-510k.jpg K240520 - Diode Laser Hair Removal System (SH-VD910) K240520 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Beijing Sea Heart International Science and Technologyco.Ltd. Cleared May 2024. https://www.510kdatabase.net/k240772/ 2024-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k240772-dental-zirconia-blank-ht-plus-st-c-st-fda-510k.jpg K240772 - Dental Zirconia Blank (HT-plus, ST-C, ST-ML, SHT-C, SHT-ML, UT-C, UT-ML, Pro- ML) K240772 is a FDA 510(k) cleared dental medical device. Manufacturer: Hunan Ceramaster Material Technology Co., Ltd.. Cleared May 2024. https://www.510kdatabase.net/k241252/ 2024-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k241252-disposable-vinyl-examination-gloves-fda-510k.jpg K241252 - Disposable Vinyl Examination Gloves K241252 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Anqing Pukang Medical Technology Co., Ltd.. Cleared May 2024. https://www.510kdatabase.net/k241276/ 2024-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k241276-vector-pedicle-screw-system-fda-510k.jpg K241276 - Vector™ Pedicle Screw System K241276 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Innovasis, Inc.. Cleared May 2024. https://www.510kdatabase.net/k220891/ 2024-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k220891-kahook-dual-blade-glide-kdb-glide-fda-510k.jpg K220891 - Kahook Dual Blade Glide (KDB Glide) K220891 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: New World Medical, Inc.. Cleared May 2024. https://www.510kdatabase.net/k232516/ 2024-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k232516-sentec-digital-monitoring-system-sdms-fda-510k.jpg K232516 - Sentec Digital Monitoring System (SDMS) tCOM+ K232516 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sentec AG. Cleared May 2024. https://www.510kdatabase.net/k232525/ 2024-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k232525-yonifit-bladder-support-fda-510k.jpg K232525 - Yoni.Fit Bladder Support K232525 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Watkins-Conti Products, Inc.. Cleared May 2024. https://www.510kdatabase.net/k232793/ 2024-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k232793-curlin-8000-ambulatory-infusion-system-fda-510k.jpg K232793 - Curlin 8000 Ambulatory Infusion System K232793 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zevex, Inc.. Cleared May 2024. https://www.510kdatabase.net/k233209/ 2024-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k233209-uomnispacect-fda-510k.jpg K233209 - uOmnispace.CT K233209 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared May 2024. https://www.510kdatabase.net/k233215/ 2024-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k233215-icotec-anterior-cervical-plate-system-fda-510k.jpg K233215 - icotec Anterior Cervical Plate System K233215 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Icotec AG. Cleared May 2024. https://www.510kdatabase.net/k233236/ 2024-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k233236-radiance-v5-fda-510k.jpg K233236 - Radiance V5 K233236 is a FDA 510(k) cleared radiology medical device. Manufacturer: Gmv Soluciones Globales Internet S.A.U.. Cleared May 2024. https://www.510kdatabase.net/k233933/ 2024-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k233933-cirrus-hd-oct-model-6000-fda-510k.jpg K233933 - CIRRUS™ HD-OCT Model 6000 K233933 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Carl Zeiss Meditec, Inc.. Cleared May 2024. https://www.510kdatabase.net/k240482/ 2024-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k240482-intense-pulsed-light-system-st-690-fda-510k.jpg K240482 - Intense Pulsed Light System (ST-690) K240482 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smedtrum Medical Technology Co., Ltd.. Cleared May 2024. https://www.510kdatabase.net/k240935/ 2024-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k240935-arenal-anterior-cervical-plate-system-fda-510k.jpg K240935 - ARENAL Anterior Cervical Plate System K240935 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Effortmed, LLC. Cleared May 2024. https://www.510kdatabase.net/k241042/ 2024-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k241042-safesharp-transseptal-needle-click071-fda-510k.jpg K241042 - SafeSharp Transseptal Needle (CLICK071, CLICK171, CLICK098, CLICK198) K241042 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Pressure Products Medical Device Manufacturing, LLC. Cleared May 2024. https://www.510kdatabase.net/k241175/ 2024-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k241175-mirus-more-lumbar-plating-system-fda-510k.jpg K241175 - MiRus MoRe Lumbar Plating System K241175 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: MiRus, LLC. Cleared May 2024. https://www.510kdatabase.net/den230035/ 2024-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/den230035-dentalmonitoring-fda-510k.jpg DEN230035 - DentalMonitoring DEN230035 is a FDA 510(k) cleared dental medical device. Manufacturer: Dental Monitoring Sas. Cleared May 2024. https://www.510kdatabase.net/k230711/ 2024-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k230711-pain-therapy-devicemodel-pts-x-fda-510k.jpg K230711 - Pain Therapy Device(Model: P.T.S-X) K230711 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Guangzhou Xinbo Electronic Co., Ltd.. Cleared May 2024. https://www.510kdatabase.net/k232495/ 2024-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k232495-sempulse-halo-vital-signs-monitor-fda-510k.jpg K232495 - Sempulse Halo Vital Signs Monitor K232495 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sempulse Corporation. Cleared May 2024. https://www.510kdatabase.net/k232542/ 2024-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k232542-wedge-xl-delivery-catheter-fda-510k.jpg K232542 - Wedge XL Delivery Catheter K232542 is a FDA 510(k) cleared neurology medical device. Manufacturer: MicroVention, Inc.. Cleared May 2024. https://www.510kdatabase.net/k232786/ 2024-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k232786-stimulation-system-pa-series-pr-series-fda-510k.jpg K232786 - Stimulation System (PA series, PR series, S series and Q series) K232786 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Edan Instruments, Inc.. Cleared May 2024. https://www.510kdatabase.net/k232849/ 2024-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k232849-halyard-tri-layer-aami-3-isolation-fda-510k.jpg K232849 - Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311) K232849 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Owens & Minor (O&M) Halyard, Inc.. Cleared May 2024. https://www.510kdatabase.net/k232933/ 2024-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k232933-airkee-p900-fda-510k.jpg K232933 - AirKEE P900 K232933 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Healkee Medical Pte, Ltd.. Cleared May 2024. https://www.510kdatabase.net/k233137/ 2024-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k233137-ticare-dental-implant-systems-fda-510k.jpg K233137 - Ticare Dental Implant Systems K233137 is a FDA 510(k) cleared dental medical device. Manufacturer: Mozograu S.A.. Cleared May 2024. https://www.510kdatabase.net/k233473/ 2024-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k233473-deka-lotus-fda-510k.jpg K233473 - DEKA LOTUS K233473 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: El.En S.P.A.. Cleared May 2024. https://www.510kdatabase.net/k233625/ 2024-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k233625-raydent-sw-fda-510k.jpg K233625 - RAYDENT SW K233625 is a FDA 510(k) cleared dental medical device. Manufacturer: Ray Co., Ltd.. Cleared May 2024. https://www.510kdatabase.net/k233841/ 2024-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k233841-hd80-series-ultrasound-diagnostic-system-fda-510k.jpg K233841 - HD80 Series Ultrasound Diagnostic System K233841 is a FDA 510(k) cleared radiology medical device. Manufacturer: Qingdao Hisense Medical Equipment Co., Ltd.. Cleared May 2024. https://www.510kdatabase.net/k240059/ 2024-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k240059-fagamin-fda-510k.jpg K240059 - FAgamin® K240059 is a FDA 510(k) cleared dental medical device. Manufacturer: Tedequim Srl. Cleared May 2024. https://www.510kdatabase.net/k240328/ 2024-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k240328-exciteosa-without-remote-control-3000-fda-510k.jpg K240328 - eXciteOSA without remote control (3000) K240328 is a FDA 510(k) cleared dental medical device. Manufacturer: Signifier Medical Technologies, Ltd.. Cleared May 2024. https://www.510kdatabase.net/k240386/ 2024-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k240386-picosecond-ndyag-laser-systems-bl-c10-fda-510k.jpg K240386 - Picosecond Nd:YAG Laser Systems (BL-C10) K240386 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shanghai Bele Medical Technology Co.,Ltd. Cleared May 2024. https://www.510kdatabase.net/k240445/ 2024-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k240445-the-sensititre-20-24-hour-haemophilus-fda-510k.jpg K240445 - The Sensititre 20 - 24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or Breakpoint Susceptibility System with Imipenem in the dilution range of 0.015 - 4 ug/ml. K240445 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Thermo Fisher Scientific. Cleared May 2024. https://www.510kdatabase.net/k240752/ 2024-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k240752-deka-toro-fda-510k.jpg K240752 - DEKA TORO K240752 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: El.En S.P.A.. Cleared May 2024. https://www.510kdatabase.net/k241039/ 2024-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k241039-reshape-calibration-tubes-b-2032-b-fda-510k.jpg K241039 - ReShape Calibration Tubes (B-2032, B-2036, B-2040) K241039 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Reshape Lifesciences. Cleared May 2024. https://www.510kdatabase.net/k231940/ 2024-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k231940-bruxzir-now-src-fda-510k.jpg K231940 - BruxZir® NOW SRC K231940 is a FDA 510(k) cleared dental medical device. Manufacturer: Prismatik Dentalcraft, Inc.. Cleared May 2024. https://www.510kdatabase.net/k233247/ 2024-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k233247-heuron-ich-fda-510k.jpg K233247 - Heuron ICH K233247 is a FDA 510(k) cleared radiology medical device. Manufacturer: Heuron Co., Ltd.. Cleared May 2024. https://www.510kdatabase.net/k233985/ 2024-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k233985-triux-neo-nm27000n-fda-510k.jpg K233985 - TRIUX™ neo (NM27000N ) K233985 is a FDA 510(k) cleared neurology medical device. Manufacturer: Megin OY. Cleared May 2024. https://www.510kdatabase.net/k240278/ 2024-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k240278-full-wedge-lateralized-and-augmented-fda-510k.jpg K240278 - Full Wedge Lateralized and Augmented Baseplates K240278 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Fx Shoulder USA, Inc.. Cleared May 2024. https://www.510kdatabase.net/k240368/ 2024-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k240368-e3d-a-interbody-system-fda-510k.jpg K240368 - E3D™-A Interbody System K240368 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Evolution Spine. Cleared May 2024. https://www.510kdatabase.net/k241043/ 2024-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k241043-augment-off-axis-instrument-system-fda-510k.jpg K241043 - Augment Off-Axis Instrument System K241043 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Fix Surgical. Cleared May 2024. https://www.510kdatabase.net/k241049/ 2024-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k241049-canon-fundus-camera-cr-10-cr-10-fda-510k.jpg K241049 - CANON Fundus Camera CR-10 (CR-10) K241049 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Canon, Inc.. Cleared May 2024. https://www.510kdatabase.net/k241053/ 2024-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k241053-mvr-venous-reservoir-bag-800-ml-fda-510k.jpg K241053 - MVR™ Venous Reservoir Bag 800 mL K241053 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Cardiac Surgery. Cleared May 2024. https://www.510kdatabase.net/k241112/ 2024-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k241112-briefcase-quantification-fda-510k.jpg K241112 - BriefCase-Quantification K241112 is a FDA 510(k) cleared radiology medical device. Manufacturer: Aidoc Medical , Ltd.. Cleared May 2024. https://www.510kdatabase.net/den230043/ 2024-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/den230043-notal-vision-home-optical-coherence-fda-510k.jpg DEN230043 - Notal Vision Home Optical Coherence Tomography (OCT) System DEN230043 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Notal Vision, Inc.. Cleared May 2024. https://www.510kdatabase.net/k232662/ 2024-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k232662-bnle-hydrophilic-jacketed-peripheral-fda-510k.jpg K232662 - BNLE Hydrophilic Jacketed Peripheral Guidewire K232662 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biomerics Nle. Cleared May 2024. https://www.510kdatabase.net/k233913/ 2024-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k233913-electric-breast-pump-brp-301-fda-510k.jpg K233913 - Electric Breast Pump (BRP-301) K233913 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Aoj Health Technology Co., Ltd.. Cleared May 2024. https://www.510kdatabase.net/k240426/ 2024-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k240426-aventus-clot-management-system-fda-510k.jpg K240426 - Aventus Clot Management System K240426 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inquis Medical. Cleared May 2024. https://www.510kdatabase.net/k232242/ 2024-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k232242-bear-2-body-fda-510k.jpg K232242 - BEAR 2 Body K232242 is a FDA 510(k) cleared neurology medical device. Manufacturer: Foreo, Inc.. Cleared May 2024. https://www.510kdatabase.net/k232529/ 2024-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k232529-disposable-double-lumen-endobronchial-fda-510k.jpg K232529 - Disposable Double Lumen Endobronchial Tube K232529 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Insighters Medical Technology Co., Ltd.. Cleared May 2024. https://www.510kdatabase.net/k232614/ 2024-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k232614-non-sterile-powder-free-nitrile-fda-510k.jpg K232614 - Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl (White, Black, and Violet Blue) K232614 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sri Trang Gloves (Thailand) Public Company Limited. Cleared May 2024. https://www.510kdatabase.net/k232862/ 2024-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k232862-mim-monte-carlo-dosimetry-fda-510k.jpg K232862 - MIM – Monte Carlo Dosimetry K232862 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mim Software, Inc.. Cleared May 2024. https://www.510kdatabase.net/k233875/ 2024-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k233875-brainomix-360-e-lung-fda-510k.jpg K233875 - Brainomix 360 e-Lung K233875 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainomix Limited. Cleared May 2024. https://www.510kdatabase.net/k240658/ 2024-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k240658-1060nm-laser-body-slimming-machine-fda-510k.jpg K240658 - 1060nm laser body slimming machine K240658 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Hebei JT Medical Co., Ltd.. Cleared May 2024. https://www.510kdatabase.net/k240759/ 2024-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k240759-remex-gr100-fda-510k.jpg K240759 - REMEX-GR100 K240759 is a FDA 510(k) cleared radiology medical device. Manufacturer: Remedi Co., Ltd.. Cleared May 2024. https://www.510kdatabase.net/k240949/ 2024-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k240949-healgen-accurate-fentanyl-rapid-test-fda-510k.jpg K240949 - Healgen® Accurate Fentanyl Rapid Test Cassette (Urine) K240949 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Healgen Scientific, LLC. Cleared May 2024. https://www.510kdatabase.net/k232410/ 2024-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k232410-smartchest-fda-510k.jpg K232410 - SmartChest K232410 is a FDA 510(k) cleared radiology medical device. Manufacturer: Milvue. Cleared May 2024. https://www.510kdatabase.net/k232475/ 2024-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k232475-disposable-infusion-set-with-needle-fda-510k.jpg K232475 - Disposable infusion set with needle K232475 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shandong Zhushi Pharmaceutical Group Co., Ltd.. Cleared May 2024. https://www.510kdatabase.net/k232507/ 2024-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k232507-aerogensolo-nebulizer-system-fda-510k.jpg K232507 - Aerogen®Solo Nebulizer System K232507 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Aerogen, Ltd.. Cleared May 2024. https://www.510kdatabase.net/k233100/ 2024-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k233100-qiastat-dx-respiratory-panel-plus-fda-510k.jpg K233100 - QIAstat-Dx® Respiratory Panel Plus K233100 is a FDA 510(k) cleared microbiology medical device. Manufacturer: QIAGEN GmbH. Cleared May 2024. https://www.510kdatabase.net/k233277/ 2024-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k233277-filter-needle-for-single-use-fda-510k.jpg K233277 - Filter Needle for Single Use K233277 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hangzhou Qiantang Longyue Biotechnology Co., Ltd.. Cleared May 2024. https://www.510kdatabase.net/k233629/ 2024-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k233629-aperto-lucent-mri-system-fda-510k.jpg K233629 - APERTO Lucent MRI System K233629 is a FDA 510(k) cleared radiology medical device. Manufacturer: Fujifilm Healthcare Americas Corporation. Cleared May 2024. https://www.510kdatabase.net/k233950/ 2024-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k233950-pureflow-402-f00012067-fda-510k.jpg K233950 - pureFLOW 402 (F00012067) K233950 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC. Cleared May 2024. https://www.510kdatabase.net/k234023/ 2024-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k234023-oocyte-flushing-retrieval-medium-fda-510k.jpg K234023 - Oocyte Flushing & Retrieval Medium K234023 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Gimbo Medical Technology Shenzhen Co., Ltd.. Cleared May 2024. https://www.510kdatabase.net/k234079/ 2024-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k234079-hypersuture-extension-line-fda-510k.jpg K234079 - HyperSuture Extension Line K234079 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Threadstone, LLC. Cleared May 2024. https://www.510kdatabase.net/k240276/ 2024-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k240276-pillcam-genius-sb-system-with-pillcam-fda-510k.jpg K240276 - PillCam™ Genius SB System with PillCam Software v9.7 and PillCam Cloud Reader Software K240276 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Given Imaging Ltd. (D.B.A. Medtronic). Cleared May 2024. https://www.510kdatabase.net/k240365/ 2024-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k240365-bioceramic-root-repair-material-c-root-fda-510k.jpg K240365 - Bioceramic Root Repair Material (C-Root BP) K240365 is a FDA 510(k) cleared dental medical device. Manufacturer: Beijing C-Root Dental Medical Devices Co., Ltd.. Cleared May 2024. https://www.510kdatabase.net/k240374/ 2024-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k240374-ureterorenoscope-system-fda-510k.jpg K240374 - Ureterorenoscope System K240374 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Shenzhen HugeMed Medical Technical Development Co., Ltd.. Cleared May 2024. https://www.510kdatabase.net/k240479/ 2024-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k240479-access-ov-monitor-fda-510k.jpg K240479 - Access OV Monitor K240479 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared May 2024. https://www.510kdatabase.net/k240698/ 2024-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k240698-dochek-multi-drug-urine-test-dipcard-rx-fda-510k.jpg K240698 - Dochek® Multi-Drug Urine Test Dipcard Rx K240698 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Guangzhou Decheng Biotechnology Co., Ltd.. Cleared May 2024. https://www.510kdatabase.net/k240699/ 2024-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k240699-scarlet-ac-ti-fda-510k.jpg K240699 - SCARLET® AC-Ti K240699 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spineart SA. Cleared May 2024. https://www.510kdatabase.net/k240708/ 2024-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k240708-organic-cotton-tampon-fda-510k.jpg K240708 - Organic Cotton Tampon K240708 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Suzhou Borage Medical Technology Co., Ltd.. Cleared May 2024. https://www.510kdatabase.net/k232025/ 2024-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k232025-hushd-pro-avera-fda-510k.jpg K232025 - Hushd Pro Avera K232025 is a FDA 510(k) cleared dental medical device. Manufacturer: Good Sleep CO Pte , Ltd.. Cleared May 2024. https://www.510kdatabase.net/k232468/ 2024-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k232468-sc-medica-ffx-fda-510k.jpg K232468 - SC Medica FFX K232468 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Sc Medica. Cleared May 2024. https://www.510kdatabase.net/k232470/ 2024-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k232470-polyisoprene-extra-large-condom-fda-510k.jpg K232470 - Polyisoprene Extra Large Condom K232470 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Suretex Limited. Cleared May 2024. https://www.510kdatabase.net/k232477/ 2024-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k232477-electric-breast-pump-models-aov6818-fda-510k.jpg K232477 - Electric Breast Pump (Models AOV6818, AOV6821, AOV6826, AOV6830, AOV6852) K232477 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Jiangxi AOV Maternity & Baby Products Co., Ltd.. Cleared May 2024. https://www.510kdatabase.net/k232976/ 2024-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k232976-vuze-system-fda-510k.jpg K232976 - VUZE System K232976 is a FDA 510(k) cleared radiology medical device. Manufacturer: Vuze Medical , Ltd.. Cleared May 2024. https://www.510kdatabase.net/k233418/ 2024-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k233418-biofourmis-everion-g2-fda-510k.jpg K233418 - Biofourmis Everion+ (G2) K233418 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biofourmis Singapore Pte., Ltd.. Cleared May 2024. https://www.510kdatabase.net/k233602/ 2024-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k233602-p200te-a10700-fda-510k.jpg K233602 - P200TE (A10700) K233602 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Optos Plc.. Cleared May 2024. https://www.510kdatabase.net/k233918/ 2024-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k233918-dental-barrier-and-sleeves-fda-510k.jpg K233918 - Dental Barrier and Sleeves K233918 is a FDA 510(k) cleared dental medical device. Manufacturer: Yongqing Huaguan Dental Instruments Factory. Cleared May 2024. https://www.510kdatabase.net/k233967/ 2024-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k233967-depuy-synthes-matrixsternum-fixation-fda-510k.jpg K233967 - DePuy Synthes MatrixSTERNUM Fixation System K233967 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes GmbH. Cleared May 2024. https://www.510kdatabase.net/k233982/ 2024-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k233982-cereglide-92-catheter-system-fda-510k.jpg K233982 - CEREGLIDE 92 Catheter System K233982 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cerenovus, Inc.. Cleared May 2024. https://www.510kdatabase.net/k234112/ 2024-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k234112-customized-abutment-fda-510k.jpg K234112 - Customized Abutment K234112 is a FDA 510(k) cleared dental medical device. Manufacturer: Arum Dentistry Co., Ltd.. Cleared May 2024. https://www.510kdatabase.net/k240296/ 2024-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k240296-tulsa-pro-system-pad-105-fda-510k.jpg K240296 - Tulsa Pro System (Pad-105) K240296 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Profound Medical, Inc.. Cleared May 2024. https://www.510kdatabase.net/k240403/ 2024-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k240403-access-br-monitor-fda-510k.jpg K240403 - Access BR Monitor K240403 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared May 2024. https://www.510kdatabase.net/k240495/ 2024-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k240495-flexible-fixation-device-for-fda-510k.jpg K240495 - Flexible Fixation Device for Gynecological Applicators (GM11001960) K240495 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared May 2024. https://www.510kdatabase.net/k222292/ 2024-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k222292-fp-myairvo-3-fda-510k.jpg K222292 - F&P myAirvo 3 K222292 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Fisher & Paykel Healthcare. Cleared May 2024. https://www.510kdatabase.net/k232649/ 2024-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k232649-pegavision-hioxifilcon-a-daily-fda-510k.jpg K232649 - Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses K232649 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Pegavision Corporation. Cleared May 2024. https://www.510kdatabase.net/k233581/ 2024-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k233581-vitros-immunodiagnostic-products-total-fda-510k.jpg K233581 - VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack K233581 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Ortho-Clinical Diagnostics. Cleared May 2024. https://www.510kdatabase.net/k233803/ 2024-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k233803-ultraclear-laser-system-na-fda-510k.jpg K233803 - UltraClear Laser System (N/A) K233803 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Acclaro Corporation. Cleared May 2024. https://www.510kdatabase.net/k240964/ 2024-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k240964-flow-90-wand-fda-510k.jpg K240964 - FLOW 90? Wand K240964 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: ArthroCare Corporation. Cleared May 2024. https://www.510kdatabase.net/k240999/ 2024-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k240999-legend-x-applicator-vo-fda-510k.jpg K240999 - Legend X Applicator VO K240999 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Pollogen, Ltd.. Cleared May 2024. https://www.510kdatabase.net/k241008/ 2024-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k241008-tricera-arthroscopic-system-fda-510k.jpg K241008 - Tricera Arthroscopic System K241008 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Relign Corporation, Subsidiary of Zimmer Biomet. Cleared May 2024. https://www.510kdatabase.net/k231612/ 2024-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k231612-eve-patient-positioner-system-fda-510k.jpg K231612 - Eve Patient Positioner System K231612 is a FDA 510(k) cleared radiology medical device. Manufacturer: Leo Cancer Care. Cleared May 2024. https://www.510kdatabase.net/k232486/ 2024-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k232486-karl-storz-monopolar-resectoscopes-fda-510k.jpg K232486 - KARL STORZ Monopolar Resectoscopes with HF Cable K232486 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Karl Storz SE & CO. KG. Cleared May 2024. https://www.510kdatabase.net/k232493/ 2024-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k232493-embryo-real-time-incubator-tls301-fda-510k.jpg K232493 - Embryo Real-time Incubator (TLS301), Embryo Real-time Culture Dish (MC 2004) K232493 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Wuhan Huchuang Union Technology Co., Ltd.. Cleared May 2024. https://www.510kdatabase.net/k232833/ 2024-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k232833-halo-ap-dx-fda-510k.jpg K232833 - HALO AP Dx K232833 is a FDA 510(k) cleared pathology medical device. Manufacturer: Indica Labs, Inc.. Cleared May 2024. https://www.510kdatabase.net/k232928/ 2024-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k232928-deepcontour-v10-fda-510k.jpg K232928 - DeepContour (V1.0) K232928 is a FDA 510(k) cleared radiology medical device. Manufacturer: Wisdom Technologies., Inc.. Cleared May 2024. https://www.510kdatabase.net/k233695/ 2024-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k233695-medical-hal-lower-limb-type-hal-ml-fda-510k.jpg K233695 - Medical HAL Lower Limb Type (HAL-ML) K233695 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cyberdyne, Inc.. Cleared May 2024. https://www.510kdatabase.net/k233766/ 2024-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k233766-geneo-x-elite-fda-510k.jpg K233766 - Geneo X Elite K233766 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Pollogen, Ltd.. Cleared May 2024. https://www.510kdatabase.net/k233864/ 2024-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k233864-assure-wearable-ecg-fda-510k.jpg K233864 - ASSURE Wearable ECG K233864 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Kestra Medical Technologies, Inc.. Cleared May 2024. https://www.510kdatabase.net/k234018/ 2024-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k234018-cerec-cercon-4d-abutment-blocks-cerec-fda-510k.jpg K234018 - CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment System K234018 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona. Cleared May 2024. https://www.510kdatabase.net/k234039/ 2024-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k234039-aeon-endoscopic-powered-stapler-fda-510k.jpg K234039 - AEON Endoscopic Powered Stapler (Short/AEPH060) K234039 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lexington Medical, Inc.. Cleared May 2024. https://www.510kdatabase.net/k240377/ 2024-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k240377-lifepak-ecg-cables-fda-510k.jpg K240377 - LIFEPAK® ECG Cables K240377 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Stryker Physio-Control. Cleared May 2024. https://www.510kdatabase.net/k240954/ 2024-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k240954-shockwave-intravascular-lithotripsy-fda-510k.jpg K240954 - Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter K240954 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shockwave Medical, Inc.. Cleared May 2024. https://www.510kdatabase.net/k232514/ 2024-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k232514-mim-dose-analysis-fda-510k.jpg K232514 - MIM – Dose Analysis K232514 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mim Software, Inc.. Cleared May 2024. https://www.510kdatabase.net/k233800/ 2024-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k233800-vertos-mild-device-kit-mdk-0002-fda-510k.jpg K233800 - Vertos mild Device Kit (MDK-0002) K233800 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Vertos Medical, Inc.. Cleared May 2024. https://www.510kdatabase.net/k234033/ 2024-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k234033-visigi-lux-5332-fda-510k.jpg K234033 - ViSiGi LUX (5332) K234033 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boehringer Laboratories, LLC. Cleared May 2024. https://www.510kdatabase.net/k240007/ 2024-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k240007-solar-compact-g4-1-fda-510k.jpg K240007 - Solar Compact (G4-1) K240007 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Laborie Medical Technologies, Corp.. Cleared May 2024. https://www.510kdatabase.net/k240392/ 2024-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k240392-jazz-spinal-system-fda-510k.jpg K240392 - JAZZ Spinal System K240392 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Implanet. Cleared May 2024. https://www.510kdatabase.net/k240685/ 2024-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k240685-salvo-spine-system-fda-510k.jpg K240685 - Salvo® Spine System K240685 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spine Wave, Inc.. Cleared May 2024. https://www.510kdatabase.net/k232416/ 2024-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k232416-aution-eye-ai-4510-urine-particle-fda-510k.jpg K232416 - AUTION EYE AI-4510 Urine Particle Analysis System K232416 is a FDA 510(k) cleared immunology medical device. Manufacturer: Arkray, Inc.. Cleared May 2024. https://www.510kdatabase.net/k232454/ 2024-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k232454-viral-transport-media-vtm-fda-510k.jpg K232454 - Viral Transport Media (VTM) K232454 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Alb Luz. Cleared May 2024. https://www.510kdatabase.net/k232491/ 2024-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k232491-ct-5300-fda-510k.jpg K232491 - CT 5300 K232491 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Healthcare (Suzhou) Co., Ltd.. Cleared May 2024. https://www.510kdatabase.net/k232648/ 2024-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k232648-rodeo-telescopic-nail-fda-510k.jpg K232648 - RODEO Telescopic Nail K232648 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthofix Srl. Cleared May 2024. https://www.510kdatabase.net/k232733/ 2024-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k232733-mbrace-cable-fda-510k.jpg K232733 - Mbrace Cable K232733 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared May 2024. https://www.510kdatabase.net/k232735/ 2024-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k232735-ema-3d-fda-510k.jpg K232735 - EMA 3D K232735 is a FDA 510(k) cleared dental medical device. Manufacturer: Ema Sleep Incorporated. Cleared May 2024. https://www.510kdatabase.net/k232776/ 2024-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k232776-tablo-hemodialysis-system-fda-510k.jpg K232776 - Tablo® Hemodialysis System K232776 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Outset Medical, Inc.. Cleared May 2024. https://www.510kdatabase.net/k232895/ 2024-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k232895-b-ultrasound-diagnostic-system-fda-510k.jpg K232895 - B-Ultrasound Diagnostic System K232895 is a FDA 510(k) cleared radiology medical device. Manufacturer: Contec Medical Systems Co.,Ltd. Cleared May 2024. https://www.510kdatabase.net/k232941/ 2024-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k232941-megaloop-button-system-fda-510k.jpg K232941 - Megaloop Button System K232941 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Suzhou Endophix Co., Ltd.. Cleared May 2024. https://www.510kdatabase.net/k233157/ 2024-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k233157-vapormax-ldd-fda-510k.jpg K233157 - VaporMAX LDD K233157 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Innovaquartz, LLC. Cleared May 2024. https://www.510kdatabase.net/k233349/ 2024-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k233349-alinity-m-hsv-1-2-vzv-fda-510k.jpg K233349 - Alinity m HSV 1 & 2 / VZV K233349 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Molecular, Inc.. Cleared May 2024. https://www.510kdatabase.net/k233524/ 2024-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k233524-sleeved-ic-2-family-fda-510k.jpg K233524 - Sleeved IC 2 Family K233524 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hollister Incorporated. Cleared May 2024. https://www.510kdatabase.net/k233687/ 2024-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k233687-echelon-synergy-v100-fda-510k.jpg K233687 - ECHELON Synergy V10.0 K233687 is a FDA 510(k) cleared radiology medical device. Manufacturer: Fujifilm Healthcare Americas Corporation. Cleared May 2024. https://www.510kdatabase.net/k234021/ 2024-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k234021-masimo-stork-fda-510k.jpg K234021 - Masimo Stork K234021 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Masimo Corporation. Cleared May 2024. https://www.510kdatabase.net/k234088/ 2024-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k234088-emilys-care-nourish-test-system-model-1-fda-510k.jpg K234088 - Emily's Care Nourish Test System (Model 1) K234088 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Lactation Lab, Inc.. Cleared May 2024. https://www.510kdatabase.net/k240126/ 2024-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k240126-proam-alif-system-fda-510k.jpg K240126 - ProAM ALIF System K240126 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Pro Surgical, Inc.. Cleared May 2024. https://www.510kdatabase.net/k240185/ 2024-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k240185-cypris-exact-suture-placement-device-fda-510k.jpg K240185 - Cypris eXact Suture Placement Device K240185 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cypris Medical. Cleared May 2024. https://www.510kdatabase.net/k240297/ 2024-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k240297-canady-helios-cold-plasma-xl-1000cp-fda-510k.jpg K240297 - Canady Helios Cold Plasma™ XL-1000CP™ Ablation System (XL-1000CPSYS) K240297 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Us Medical Innovations, LLC. Cleared May 2024. https://www.510kdatabase.net/k240625/ 2024-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k240625-corus-navigation-access-system-fda-510k.jpg K240625 - CORUS Navigation Access System K240625 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Providence Medical Technology, Inc.. Cleared May 2024. https://www.510kdatabase.net/k240800/ 2024-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k240800-access-intrinsic-factor-ab-fda-510k.jpg K240800 - Access Intrinsic Factor Ab K240800 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared May 2024. https://www.510kdatabase.net/k240919/ 2024-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k240919-silk-voice-smi-04-fda-510k.jpg K240919 - Silk Voice (SMI-04) K240919 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Sofregen Medical. Cleared May 2024. https://www.510kdatabase.net/k240940/ 2024-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k240940-vial2bag-advanced-20mm-admixture-device-fda-510k.jpg K240940 - Vial2Bag Advanced® 20mm Admixture Device K240940 is a FDA 510(k) cleared general hospital medical device. Manufacturer: West Pharmaceutical Services, Inc.. Cleared May 2024. https://www.510kdatabase.net/k232445/ 2024-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k232445-csf-4-csf-4-fda-510k.jpg K232445 - CSF-4 (CSF-4) K232445 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cardiacsense. Cleared May 2024. https://www.510kdatabase.net/k232464/ 2024-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k232464-veresee-optical-veres-needle-system-fda-510k.jpg K232464 - VereSee Optical Veres Needle System K232464 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Freyja Healthcare, LLC. Cleared May 2024. https://www.510kdatabase.net/k232902/ 2024-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k232902-eva15-insufflator-fda-510k.jpg K232902 - EVA15 insufflator K232902 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Palliare , Ltd.. Cleared May 2024. https://www.510kdatabase.net/k232908/ 2024-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k232908-color-doppler-ultrasound-diagnostic-fda-510k.jpg K232908 - Color Doppler Ultrasound Diagnostic System (CMS1700B), Color Doppler Ultrasound Diagnostic System (CMS1700C) K232908 is a FDA 510(k) cleared radiology medical device. Manufacturer: Contec Medical Systems Co.,Ltd. Cleared May 2024. https://www.510kdatabase.net/k233689/ 2024-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k233689-hopeher-vaginal-dilators-fda-510k.jpg K233689 - Hope&Her Vaginal Dilators K233689 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Lujena, Inc.. Cleared May 2024. https://www.510kdatabase.net/k233752/ 2024-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k233752-dragonfly-pancreaticobiliary-scope-fda-510k.jpg K233752 - Dragonfly™ Pancreaticobiliary Scope K233752 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: CenterPoint Systems, LLC. Cleared May 2024. https://www.510kdatabase.net/k233857/ 2024-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k233857-neodent-implant-system-custom-abutments-fda-510k.jpg K233857 - Neodent Implant System – Custom Abutments K233857 is a FDA 510(k) cleared dental medical device. Manufacturer: JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A.. Cleared May 2024. https://www.510kdatabase.net/k240012/ 2024-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k240012-mobility-scooter-w3431-fda-510k.jpg K240012 - Mobility Scooter (W3431) K240012 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zhejiang Innuovo Rehabilitation Devices Co.,Ltd. Cleared May 2024. https://www.510kdatabase.net/k240037/ 2024-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k240037-revi-system-fda-510k.jpg K240037 - Revi™ System K240037 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Bluewind Medical , Ltd.. Cleared May 2024. https://www.510kdatabase.net/k240261/ 2024-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k240261-siege-vascular-plug-svp25-0021-fda-510k.jpg K240261 - Siege Vascular Plug (SVP2.5-0.021) K240261 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared May 2024. https://www.510kdatabase.net/k240636/ 2024-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k240636-hemoscreen-hematology-analyzer-fda-510k.jpg K240636 - HemoScreen Hematology Analyzer K240636 is a FDA 510(k) cleared hematology medical device. Manufacturer: Pixcell Medical Technologies. Cleared May 2024. https://www.510kdatabase.net/k231722/ 2024-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k231722-smartooth-fda-510k.jpg K231722 - SmarTooth K231722 is a FDA 510(k) cleared dental medical device. Manufacturer: Smartooth Co., Ltd.. Cleared May 2024. https://www.510kdatabase.net/k232370/ 2024-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k232370-percutaneous-nephroscope-system-fda-510k.jpg K232370 - Percutaneous Nephroscope System K232370 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Karl Storz SE & CO. KG. Cleared May 2024. https://www.510kdatabase.net/k232858/ 2024-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k232858-orskin-blue-fda-510k.jpg K232858 - ORskin Blue K232858 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Megabay S.A.. Cleared May 2024. https://www.510kdatabase.net/k233203/ 2024-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k233203-soft-tissue-augmentation-resorbable-fda-510k.jpg K233203 - Soft Tissue Augmentation Resorbable Matrix K233203 is a FDA 510(k) cleared dental medical device. Manufacturer: Collagen Matrix, Inc.. Cleared May 2024. https://www.510kdatabase.net/k233284/ 2024-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k233284-vial-adapter-with-filter-fda-510k.jpg K233284 - Vial Adapter with Filter K233284 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hangzhou Qiantang Longyue Biotechnology Co., Ltd.. Cleared May 2024. https://www.510kdatabase.net/k233513/ 2024-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k233513-remex-spine-surgery-navigation-system-ii-fda-510k.jpg K233513 - Remex Spine Surgery Navigation System II K233513 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Remex Medical Corp.. Cleared May 2024. https://www.510kdatabase.net/k233516/ 2024-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k233516-tono-vera-tonometer-and-ocu-dot-fda-510k.jpg K233516 - Tono-Vera® Tonometer and Ocu-Dot® Tonometer Probes (16305, 16306, 16318) K233516 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Reichert, Inc.. Cleared May 2024. https://www.510kdatabase.net/k234113/ 2024-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k234113-miis-horus-bronchoscope-fda-510k.jpg K234113 - MiiS Horus Bronchoscope K234113 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Medimaging Integrated Solution, Inc (Miis). Cleared May 2024. https://www.510kdatabase.net/k240279/ 2024-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k240279-vidas-tbi-gfap-uch-l1-fda-510k.jpg K240279 - VIDAS TBI (GFAP, UCH-L1) K240279 is a FDA 510(k) cleared immunology medical device. Manufacturer: bioMerieux, Inc.. Cleared May 2024. https://www.510kdatabase.net/k240829/ 2024-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k240829-aust-steerable-sheath-fda-510k.jpg K240829 - AuST Steerable Sheath K240829 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: CenterPoint Systems, LLC. Cleared May 2024. https://www.510kdatabase.net/k240882/ 2024-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k240882-bruxzir-esthetic-fda-510k.jpg K240882 - BruxZir® Esthetic K240882 is a FDA 510(k) cleared dental medical device. Manufacturer: Prismatik Dentalcraft, Inc.. Cleared May 2024. https://www.510kdatabase.net/k240900/ 2024-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k240900-hotwire-rf-guidewire-fda-510k.jpg K240900 - HOTWIRE™ RF Guidewire K240900 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Atraverse Medical. Cleared May 2024. https://www.510kdatabase.net/k240925/ 2024-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k240925-duragraft-vascular-conduit-solution-fda-510k.jpg K240925 - DuraGraft Vascular Conduit Solution K240925 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Marizyme. Cleared May 2024. https://www.510kdatabase.net/k240986/ 2024-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k240986-cold-compression-fda-510k.jpg K240986 - Cold Compression K240986 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Jkh Health Co., Ltd.. Cleared May 2024. https://www.510kdatabase.net/k232528/ 2024-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k232528-protective-cap-fda-510k.jpg K232528 - Protective Cap K232528 is a FDA 510(k) cleared dental medical device. Manufacturer: Neobiotech Co., Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k232889/ 2024-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k232889-meticuly-patient-specific-titanium-fda-510k.jpg K232889 - METICULY Patient-specific titanium maxillofacial mesh implant K232889 is a FDA 510(k) cleared dental medical device. Manufacturer: Meticuly Co., Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k232923/ 2024-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k232923-ethos-treatment-management-30-fda-510k.jpg K232923 - Ethos Treatment Management (3.0) K232923 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k233122/ 2024-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k233122-high-speed-air-turbine-handpiece-fda-510k.jpg K233122 - High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L) K233122 is a FDA 510(k) cleared dental medical device. Manufacturer: Litu Tech , Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k233231/ 2024-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k233231-dental-implants-and-abutments-fda-510k.jpg K233231 - Dental Implants and Abutments K233231 is a FDA 510(k) cleared dental medical device. Manufacturer: Ditron Dental, Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k233403/ 2024-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k233403-flexset-system-fda-510k.jpg K233403 - Flexset System K233403 is a FDA 510(k) cleared neurology medical device. Manufacturer: Zeto, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k240118/ 2024-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k240118-picosecond-ndyag-laser-system-fda-510k.jpg K240118 - Picosecond Nd:YAG Laser System K240118 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smedtrum Medical Technology Co., Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k240156/ 2024-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k240156-lifepak-invasive-pressure-adapter-fda-510k.jpg K240156 - LIFEPAK® Invasive Pressure Adapter Cable (Interfaces with ICU Medical Transpack IV Invasive Pressure Transducers (or equivalent)) (11230-000021) K240156 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Physio-Control, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k240621/ 2024-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k240621-morpheus-moldable-fda-510k.jpg K240621 - Morpheus® Moldable K240621 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biogennix, LLC. Cleared Apr 2024. https://www.510kdatabase.net/k232511/ 2024-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k232511-medline-renewal-reprocessed-ligasure-fda-510k.jpg K232511 - Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019) K232511 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Surgical Instrument Service and Savings, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k233699/ 2024-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k233699-subtlereformat-1x-fda-510k.jpg K233699 - SubtleREFORMAT (1.x) K233699 is a FDA 510(k) cleared radiology medical device. Manufacturer: Subtle Medical, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k233939/ 2024-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k233939-ultraflex-esophageal-ng-stent-system-fda-510k.jpg K233939 - Ultraflex Esophageal NG Stent System K233939 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific. Cleared Apr 2024. https://www.510kdatabase.net/k240062/ 2024-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k240062-arvis-shoulder-fda-510k.jpg K240062 - ARVIS® Shoulder K240062 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Insight Medical Systems, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k240102/ 2024-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k240102-blood-pressure-monitor-tmb-2287-b-fda-510k.jpg K240102 - Blood Pressure Monitor (TMB-2287-B) K240102 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Guangdong Transtek Medical Electronics Co., Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k240248/ 2024-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k240248-volnewmer-fda-510k.jpg K240248 - Volnewmer™ K240248 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Classys, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k240526/ 2024-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k240526-poweream-xiaserrato-fda-510k.jpg K240526 - POWEReam Xia/Serrato K240526 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Instruments. Cleared Apr 2024. https://www.510kdatabase.net/k240568/ 2024-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k240568-durapro-oscillating-system-fda-510k.jpg K240568 - DuraPro™ Oscillating System K240568 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k240584/ 2024-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k240584-xtra-autotransfusion-system-with-xtra-fda-510k.jpg K240584 - XTRA Autotransfusion System (with XTRA Bowl sets) K240584 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sorin Group Italia S.R.L.. Cleared Apr 2024. https://www.510kdatabase.net/k240591/ 2024-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k240591-restor3d-kinos-axiom-total-ankle-system-fda-510k.jpg K240591 - restor3d Kinos Axiom Total Ankle System K240591 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Restor3D, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/den230052/ 2024-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/den230052-eversense-ap-cgm-system-fda-510k.jpg DEN230052 - Eversense AP CGM System DEN230052 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Senseonics, Incorporated. Cleared Apr 2024. https://www.510kdatabase.net/k220272/ 2024-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k220272-cobas-pulse-blood-glucose-monitoring-fda-510k.jpg K220272 - cobas pulse blood glucose monitoring system K220272 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Apr 2024. https://www.510kdatabase.net/k221688/ 2024-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k221688-astar-bc-g-kit-and-astar-instrument-fda-510k.jpg K221688 - ASTar BC G- Kit and ASTar Instrument K221688 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Q-Linea AB. Cleared Apr 2024. https://www.510kdatabase.net/k232038/ 2024-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k232038-biostar-single-use-transbronchial-fda-510k.jpg K232038 - BioStar Single Use Transbronchial Aspiration Needle K232038 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Broncus Medical, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k232261/ 2024-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k232261-tme-temporary-myocardial-electrode-fda-510k.jpg K232261 - TME Temporary Myocardial Electrode K232261 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Osypka AG. Cleared Apr 2024. https://www.510kdatabase.net/k232298/ 2024-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k232298-digital-radiography-cxdi-rf-wireless-bl-fda-510k.jpg K232298 - DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl K232298 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k232302/ 2024-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k232302-pocket-iii-fda-510k.jpg K232302 - Pocket III K232302 is a FDA 510(k) cleared radiology medical device. Manufacturer: Quantel Medical. Cleared Apr 2024. https://www.510kdatabase.net/k232317/ 2024-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k232317-uc-1800-automatic-urine-analyzer-urit-fda-510k.jpg K232317 - UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips K232317 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Urit Medical Electronic Co., Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k232435/ 2024-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k232435-rhinolaryngoscope-system-fda-510k.jpg K232435 - Rhinolaryngoscope system K232435 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Shenzhen HugeMed Medical Technical Development Co., Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k232799/ 2024-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k232799-syngovia-rt-image-suite-fda-510k.jpg K232799 - syngo.via RT Image Suite K232799 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k233583/ 2024-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k233583-fct-istream-phase-1-fda-510k.jpg K233583 - FCT iSTREAM Phase 1 K233583 is a FDA 510(k) cleared radiology medical device. Manufacturer: Fujifilm Healthcare Americas Corporation. Cleared Apr 2024. https://www.510kdatabase.net/k233673/ 2024-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k233673-umr-jupiter-fda-510k.jpg K233673 - uMR Jupiter K233673 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k233703/ 2024-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k233703-bone-anchor-ngs-ba-01-fda-510k.jpg K233703 - Bone Anchor (NGS-BA-01) K233703 is a FDA 510(k) cleared neurology medical device. Manufacturer: ClearPoint Neuro, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k233873/ 2024-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k233873-xlo-brand-of-locking-distal-humerus-fda-510k.jpg K233873 - XLO Brand of Locking Distal Humerus Plating System K233873 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ortho Life Systems Private Limited. Cleared Apr 2024. https://www.510kdatabase.net/k240091/ 2024-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k240091-nb-mini-implant-system-fda-510k.jpg K240091 - NB Mini Implant System K240091 is a FDA 510(k) cleared dental medical device. Manufacturer: Arum Dentistry Co., Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k240299/ 2024-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k240299-persona-the-personalized-knee-system-fda-510k.jpg K240299 - Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella) K240299 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k240324/ 2024-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k240324-empowr-revision-symmetric-knee-cones-fda-510k.jpg K240324 - EMPOWR Revision Symmetric Knee Cones K240324 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Encore Medical, L.P Dba Enovis. Cleared Apr 2024. https://www.510kdatabase.net/k240406/ 2024-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k240406-sonio-detect-fda-510k.jpg K240406 - Sonio Detect K240406 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sonio. Cleared Apr 2024. https://www.510kdatabase.net/k240566/ 2024-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k240566-reef-l-interbody-system-fda-510k.jpg K240566 - Reef L Interbody System K240566 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared Apr 2024. https://www.510kdatabase.net/k240872/ 2024-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k240872-erisma-deformity-spinal-system-fda-510k.jpg K240872 - Erisma® Deformity Spinal System K240872 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Clariance. Cleared Apr 2024. https://www.510kdatabase.net/k240879/ 2024-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k240879-esophyx-z-device-with-serosafuse-fda-510k.jpg K240879 - EsophyX Z+ Device with SerosaFuse Fasteners and Accessories K240879 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Endogastric Solutions, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k231142/ 2024-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k231142-temporis-irix-plus-fda-510k.jpg K231142 - Temporis, Irix Plus K231142 is a FDA 510(k) cleared dental medical device. Manufacturer: Dws S.R.L.. Cleared Apr 2024. https://www.510kdatabase.net/k232246/ 2024-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k232246-1-pinion-pdo-knotless-suture-fda-510k.jpg K232246 - 1) PINION™ PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture K232246 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: M/s. Meril Endo Surgery Private Limited.. Cleared Apr 2024. https://www.510kdatabase.net/k232331/ 2024-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k232331-invision-precision-lvef-lvef-fda-510k.jpg K232331 - InVision Precision LVEF (LVEF) K232331 is a FDA 510(k) cleared radiology medical device. Manufacturer: Invision Medical Technology Corporation. Cleared Apr 2024. https://www.510kdatabase.net/k232357/ 2024-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k232357-copan-universal-transport-medium-utm-fda-510k.jpg K232357 - Copan Universal Transport Medium (UTM-RT) System K232357 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Copan Italia Spa. Cleared Apr 2024. https://www.510kdatabase.net/k232405/ 2024-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k232405-endofix-exo-fda-510k.jpg K232405 - ENDOFIX EXO K232405 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aktormed GmbH. Cleared Apr 2024. https://www.510kdatabase.net/k232796/ 2024-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k232796-luofucon-collagen-particles-collagen-fda-510k.jpg K232796 - LUOFUCON® Collagen Particles (Collagen Wound Dressing) K232796 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Huizhou Foryou Medical Devices Co., Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k232805/ 2024-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k232805-kronos-electrocautery-device-fda-510k.jpg K232805 - Kronos Electrocautery Device K232805 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Single Pass, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k233308/ 2024-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k233308-air-motor-model-name-fx204-m4-fda-510k.jpg K233308 - Air Motor (Model name: FX204 M4) K233308 is a FDA 510(k) cleared dental medical device. Manufacturer: Nakanishi, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k233810/ 2024-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k233810-portrait-vsm-fda-510k.jpg K233810 - Portrait VSM K233810 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k234065/ 2024-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k234065-cdi-oneview-monitoring-system-fda-510k.jpg K234065 - CDI OneView Monitoring System K234065 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Cardiovascular Systems Corporation. Cleared Apr 2024. https://www.510kdatabase.net/k240535/ 2024-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k240535-digital-clarusscope-system-fda-510k.jpg K240535 - Digital ClarusScope System K240535 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Clarus Medical, LLC. Cleared Apr 2024. https://www.510kdatabase.net/k240846/ 2024-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k240846-carboclear-hybrid-pedicle-screw-system-fda-510k.jpg K240846 - CarboClear® Hybrid Pedicle Screw System K240846 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: CarboFix Orthopedics , Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k240855/ 2024-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k240855-dental-cone-beam-computed-tomography-fda-510k.jpg K240855 - Dental Cone-beam Computed Tomography K240855 is a FDA 510(k) cleared radiology medical device. Manufacturer: Yian Medical Technology (Haining) Co., Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k232181/ 2024-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k232181-body-contouring-machine-models-cs2-cs3-fda-510k.jpg K232181 - Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13) K232181 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Hebei JT Medical Co., Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k233172/ 2024-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k233172-nextar-spine-platform-fda-510k.jpg K233172 - NextAR™ Spine Platform K233172 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Apr 2024. https://www.510kdatabase.net/k233764/ 2024-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k233764-sss-nx-serum-substitute-supplement-nx-fda-510k.jpg K233764 - SSS-NX (Serum Substitute Supplement-NX) K233764 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Fujifilm Irvine Scientific. Cleared Apr 2024. https://www.510kdatabase.net/k234025/ 2024-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k234025-222mm-biolox-delta-ceramic-v40-femoral-fda-510k.jpg K234025 - 22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads K234025 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp., Dba Stryker Orthopaedics. Cleared Apr 2024. https://www.510kdatabase.net/k234056/ 2024-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k234056-canturio-se-canturio-smart-extension-fda-510k.jpg K234056 - canturio® se (Canturio Smart Extension) K234056 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Canary Medical USA, LLC. Cleared Apr 2024. https://www.510kdatabase.net/k240093/ 2024-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k240093-ipl-home-use-hair-removal-device-sj15-fda-510k.jpg K240093 - IPL Home Use Hair Removal Device (SJ15) K240093 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Shuge Medical Beauty Devices Co., Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k240208/ 2024-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k240208-dess-dental-smart-solutions-fda-510k.jpg K240208 - DESS Dental Smart Solutions K240208 is a FDA 510(k) cleared dental medical device. Manufacturer: Terrats Medical SL. Cleared Apr 2024. https://www.510kdatabase.net/k240319/ 2024-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k240319-doro-lucent-skull-clamp-1101001-fda-510k.jpg K240319 - DORO LUCENT Skull Clamp (1101.001) K240319 is a FDA 510(k) cleared neurology medical device. Manufacturer: Pro-Med Instruments GmbH. Cleared Apr 2024. https://www.510kdatabase.net/k240623/ 2024-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k240623-omnia-medical-tibrid-sa-system-fda-510k.jpg K240623 - Omnia Medical TiBrid™-SA System K240623 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Omnia Medical, LLC. Cleared Apr 2024. https://www.510kdatabase.net/k240822/ 2024-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k240822-image-management-v15-fda-510k.jpg K240822 - Image Management V15 K240822 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Technologies. Cleared Apr 2024. https://www.510kdatabase.net/k240839/ 2024-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k240839-openrad-cloud-fda-510k.jpg K240839 - OpenRad Cloud K240839 is a FDA 510(k) cleared radiology medical device. Manufacturer: Openrad Services Uk, Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k240850/ 2024-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k240850-epiq-series-diagnostic-ultrasound-fda-510k.jpg K240850 - EPIQ Series Diagnostic Ultrasound Systems K240850 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Ultrasound, LLC. Cleared Apr 2024. https://www.510kdatabase.net/k222958/ 2024-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k222958-mjoule-rf-system-and-accessories-fda-510k.jpg K222958 - mJOULE RF System and Accessories K222958 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sciton, Inc. Cleared Apr 2024. https://www.510kdatabase.net/k231699/ 2024-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k231699-quantum-patient-specific-fda-510k.jpg K231699 - QUANTUM® Patient Specific Instrumentation (PSI) System K231699 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: In2bones Sas. Cleared Apr 2024. https://www.510kdatabase.net/k233329/ 2024-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k233329-route-92-medical-full-length-054-fda-510k.jpg K233329 - Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set K233329 is a FDA 510(k) cleared neurology medical device. Manufacturer: Route 92 Medical, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k233537/ 2024-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k233537-freestyle-libre-3-continuous-glucose-fda-510k.jpg K233537 - FreeStyle Libre 3 Continuous Glucose Monitoring System K233537 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Diabetes Care, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k233849/ 2024-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k233849-btl-499-fda-510k.jpg K233849 - BTL-499 K233849 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: BTL Industries, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k233948/ 2024-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k233948-provisio-slt-ivus-system-fda-510k.jpg K233948 - Provisio™ SLT IVUS™ System K233948 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Provisio Medical, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k234107/ 2024-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k234107-solar-anorectal-manometry-catheter-fda-510k.jpg K234107 - Solar™ Anorectal Manometry Catheter (Model Number: K1210AC-L-2212) K234107 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Laborie Medical Technologies, Corp.. Cleared Apr 2024. https://www.510kdatabase.net/k234147/ 2024-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k234147-renew-xr-handpiece-25cm-with-reference-fda-510k.jpg K234147 - ReNew XR Handpiece, 25cm, with Reference Markings (3943M) K234147 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Microline Surgical, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k240058/ 2024-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k240058-aeye-ds-fda-510k.jpg K240058 - AEYE-DS K240058 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Aeye Health, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k240518/ 2024-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k240518-swiftpro-system-fda-510k.jpg K240518 - swiftPro™ System K240518 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Emblation Limited. Cleared Apr 2024. https://www.510kdatabase.net/k240816/ 2024-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k240816-mediostar-fda-510k.jpg K240816 - MeDioStar K240816 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Asclepion Laser Technologies GmbH. Cleared Apr 2024. https://www.510kdatabase.net/k240902/ 2024-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k240902-dexcom-g7-continuous-glucose-fda-510k.jpg K240902 - Dexcom G7 Continuous Glucose Monitoring System K240902 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Dexcom, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k223515/ 2024-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k223515-mamalift-plus-fda-510k.jpg K223515 - MamaLift Plus K223515 is a FDA 510(k) cleared neurology medical device. Manufacturer: Curio Digital Therapeutics, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k232319/ 2024-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k232319-black-pearl-nitrile-examination-glove-fda-510k.jpg K232319 - Black Pearl Nitrile Examination Glove K232319 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ug Global Resources Sdn. Bhd.. Cleared Apr 2024. https://www.510kdatabase.net/k233311/ 2024-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k233311-acumed-wrist-plating-system-fda-510k.jpg K233311 - Acumed Wrist Plating System K233311 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Acumed, LLC. Cleared Apr 2024. https://www.510kdatabase.net/k233582/ 2024-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k233582-rapid-fda-510k.jpg K233582 - Rapid K233582 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ischemaview, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k233966/ 2024-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k233966-anterior-spine-truss-system-stand-fda-510k.jpg K233966 - Anterior Spine Truss System-Stand Alone (ASTS-SA) K233966 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 4Web Medical, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k234041/ 2024-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k234041-fully-automatic-electronic-blood-fda-510k.jpg K234041 - Fully Automatic Electronic Blood Pressure Monitor (KD-5811VA) K234041 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Andon Health Co, Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k234068/ 2024-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k234068-art-plan-v220-fda-510k.jpg K234068 - ART-Plan (v.2.2.0) K234068 is a FDA 510(k) cleared radiology medical device. Manufacturer: Therapanacea Sas. Cleared Apr 2024. https://www.510kdatabase.net/k240115/ 2024-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k240115-resona-i8w-resona-i8-resona-i8-exp-fda-510k.jpg K240115 - Resona I8W, Resona I8, Resona I8 Exp, Resona I8S, Resona I8T, Resona IY,Resona I8 Easi, Eagus I8 Easi, Nuewa I8W, Nuewa I8, Nuewa I8 Exp, NuewaI8S, Nuewa I8T, Imagyn I8, Imagyn I8S, Imagyn I8T, Imagyn I8 Exp, Nuewa IY Diagnostic Ultrasound System K240115 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k240182/ 2024-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k240182-access-epo-fda-510k.jpg K240182 - Access EPO K240182 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k232149/ 2024-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k232149-bowtie-si-joint-fusion-system-fda-510k.jpg K232149 - BowTie™ SI Joint Fusion System K232149 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Sail Fusion, LLC. Cleared Apr 2024. https://www.510kdatabase.net/k230120/ 2024-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k230120-keyi-total-knee-system-fda-510k.jpg K230120 - KeYi Total Knee System K230120 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Beijing Keyi Medical Device Technology Co., Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k232105/ 2024-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k232105-aptus-foot-system-28-35-fda-510k.jpg K232105 - APTUS Foot System 2.8-3.5 K232105 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medartis AG. Cleared Apr 2024. https://www.510kdatabase.net/k232204/ 2024-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k232204-reyagel-rg03-mtp-gel-3ml-fda-510k.jpg K232204 - ReyaGel (RG03 - MTP gel 3mL) K232204 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Fettech. Cleared Apr 2024. https://www.510kdatabase.net/k232216/ 2024-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k232216-hemoblocks-prescription-fda-510k.jpg K232216 - Hemoblock_S (Prescription) K232216 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Incore Co., Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k232259/ 2024-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k232259-patriot-si-posterior-implant-system-fda-510k.jpg K232259 - Patriot-SI Posterior Implant System K232259 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinal Simplicity, LLC. Cleared Apr 2024. https://www.510kdatabase.net/k232377/ 2024-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k232377-healgen-rapid-covid-19-antigen-test-fda-510k.jpg K232377 - Healgen Rapid COVID-19 Antigen Test K232377 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Healgen Scientific, LLC. Cleared Apr 2024. https://www.510kdatabase.net/k232566/ 2024-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k232566-newport-spinal-system-fda-510k.jpg K232566 - NewPort Spinal System K232566 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared Apr 2024. https://www.510kdatabase.net/k232962/ 2024-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k232962-patient-monitor-ix10-ix12-ix15-fda-510k.jpg K232962 - Patient Monitor (iX10, iX12, iX15) K232962 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edan Instruments, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k233046/ 2024-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k233046-electrical-neuromuscular-stimulator-fda-510k.jpg K233046 - Electrical Neuromuscular Stimulator, Cure Trio K233046 is a FDA 510(k) cleared neurology medical device. Manufacturer: Oriental Inspiration Limited. Cleared Apr 2024. https://www.510kdatabase.net/k233106/ 2024-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k233106-accucath-ace-intravascular-catheter-fda-510k.jpg K233106 - AccuCath Ace™ Intravascular Catheter K233106 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bard Access Systems, Inc. (C.R. Bard, Inc.). Cleared Apr 2024. https://www.510kdatabase.net/k233373/ 2024-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k233373-flowflex-plus-covid-19-home-test-fda-510k.jpg K233373 - Flowflex® Plus COVID-19 Home Test K233373 is a FDA 510(k) cleared microbiology medical device. Manufacturer: ACON Laboratories, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k233737/ 2024-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k233737-ulricheasyinject-max-2m-xd-10140-fda-510k.jpg K233737 - ulricheasyINJECT Max 2M (XD 10140) K233737 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ulrich GmbH & Co. KG. Cleared Apr 2024. https://www.510kdatabase.net/k234073/ 2024-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k234073-ice-aspiration-system-fda-510k.jpg K234073 - ICE Aspiration System K234073 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Expanse Medical, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k234092/ 2024-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k234092-safeop-3-neural-informatix-systeem-fda-510k.jpg K234092 - SafeOp 3: Neural Informatix Systeem K234092 is a FDA 510(k) cleared neurology medical device. Manufacturer: Alphatec Spine, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k234119/ 2024-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k234119-unispace-stand-alone-c-cage-fda-510k.jpg K234119 - UniSpace® Stand-Alone C Cage K234119 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Innosys Co., Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k240162/ 2024-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k240162-lifepak-35-ac-power-adapter-41335-000001-fda-510k.jpg K240162 - LIFEPAK® 35 AC Power Adapter (41335-000001) K240162 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Stryker Physio-Control. Cleared Apr 2024. https://www.510kdatabase.net/k240378/ 2024-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k240378-faq-201-faq-202-fda-510k.jpg K240378 - FAQ™ 201, FAQ™ 202 K240378 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Foreo, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k240508/ 2024-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k240508-salivea-dry-mouth-moisturizing-gel-dry-fda-510k.jpg K240508 - Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel) K240508 is a FDA 510(k) cleared dental medical device. Manufacturer: Laclede, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k240534/ 2024-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k240534-bio-medicus-life-support-catheter-and-fda-510k.jpg K240534 - Bio-Medicus Life Support Catheter and Introducer K240534 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k240753/ 2024-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k240753-miro3d-fibers-wound-matrix-fda-510k.jpg K240753 - Miro3D Fibers Wound Matrix K240753 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Reprise Biomedical, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k240781/ 2024-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k240781-skout-system-fda-510k.jpg K240781 - SKOUT® system K240781 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Iterative Scopes, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k230233/ 2024-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k230233-prospera-spectruum-negative-pressure-fda-510k.jpg K230233 - Prospera Spectruum Negative Pressure Wound Therapy System K230233 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Deroyal Industries, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k232325/ 2024-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k232325-rayscan-a-expert-fda-510k.jpg K232325 - RAYSCAN a-Expert K232325 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ray Co., Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k232627/ 2024-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k232627-hotdog-warming-mattress-return-electrode-fda-510k.jpg K232627 - HotDog Warming Mattress + Return Electrode K232627 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Augustine Temperature Management, LLC. Cleared Apr 2024. https://www.510kdatabase.net/k233850/ 2024-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k233850-difiney-anti-snoring-device-fda-510k.jpg K233850 - Difiney Anti Snoring Device K233850 is a FDA 510(k) cleared dental medical device. Manufacturer: Fissiontech, LLC. Cleared Apr 2024. https://www.510kdatabase.net/k233924/ 2024-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k233924-emboguard-balloon-guide-catheter-fda-510k.jpg K233924 - EMBOGUARD Balloon Guide Catheter K233924 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neuravi Limited. Cleared Apr 2024. https://www.510kdatabase.net/k234098/ 2024-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k234098-mobility-scooter-c4-fda-510k.jpg K234098 - Mobility Scooter (C4+) K234098 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Yongkang Yile Vehicle Co., Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k240046/ 2024-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k240046-ethylene-oxide-sterilization-supplier-fda-510k.jpg K240046 - Ethylene Oxide Sterilization Supplier Change for MPO Hips K240046 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Microport Orthopedics. Cleared Apr 2024. https://www.510kdatabase.net/k240085/ 2024-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k240085-zlock-lumbar-facet-fixation-system-fda-510k.jpg K240085 - zLOCK Lumbar Facet Fixation System K240085 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zygofix , Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k240155/ 2024-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k240155-cochlear-osia-system-fda-510k.jpg K240155 - Cochlear Osia System K240155 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Cochlear Americas. Cleared Apr 2024. https://www.510kdatabase.net/k240258/ 2024-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k240258-disposable-medical-face-mask-m643be-fda-510k.jpg K240258 - Disposable Medical Face Mask (M643BE) K240258 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Makrite Industries, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k231646/ 2024-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k231646-carilex-vt200-i-nx-fda-510k.jpg K231646 - Carilex VT¿200-i NX K231646 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Carilex Medical, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k232238/ 2024-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k232238-goyo-mouthpiece-s-fda-510k.jpg K232238 - Goyo Mouthpiece S K232238 is a FDA 510(k) cleared dental medical device. Manufacturer: Dimedikorea. Cleared Apr 2024. https://www.510kdatabase.net/k233186/ 2024-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k233186-uomnispacemr-fda-510k.jpg K233186 - uOmnispace.MR K233186 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k233863/ 2024-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k233863-trimed-aset-foot-plating-system-1st-fda-510k.jpg K233863 - TriMed ASET Foot Plating System (1ST MTP 9-hole Long Plate), TriMed ASET Foot Plating System (1st Met Osteotomy Plate), TriMed ASET Foot Plating System (H-Plate), TriMed ASET Foot Plating System (Talonavicular Plate), TriMed ASET Foot Plating System (Calcaneal Slide Osteotomy Plate), TriMed ASET Foot Plating System (Evans Osteotomy Plate), TriMed ASET Foot Plating System (Medial Column Fusion Plate), TriMed ASET Foot Plating System (Straight Plate), TriMed ASET Foot Plating System (T- K233863 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: TriMed, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k240032/ 2024-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k240032-celerity-chemical-indicator-for-fda-510k.jpg K240032 - Celerity Chemical Indicator for enspire 3000 CLCSPS K240032 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Apr 2024. https://www.510kdatabase.net/k240039/ 2024-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k240039-enteral-feeding-sets-fda-510k.jpg K240039 - Enteral Feeding Sets K240039 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hangzhou Primecare Medical Co., Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k240057/ 2024-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k240057-traumaguard-intra-abdominal-pressure-fda-510k.jpg K240057 - TraumaGuard Intra-abdominal Pressure Sensing System K240057 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Sentinel Medical Technologies, LLC. Cleared Apr 2024. https://www.510kdatabase.net/k240484/ 2024-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k240484-msfx-mikron-cervical-anterior-plate-fda-510k.jpg K240484 - MSFX Mikron Cervical Anterior Plate System K240484 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Mikron Makina Sanayi VE Ticaret Ltd. Sti.. Cleared Apr 2024. https://www.510kdatabase.net/k240519/ 2024-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k240519-innova-vision-inifilcon-a-silicone-fda-510k.jpg K240519 - Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens K240519 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Innova Vision, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k232133/ 2024-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k232133-co2-laser-system-models-purelase-and-fda-510k.jpg K232133 - Co2 Laser System, Models: PureLase And VanLase K232133 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cpmt Laser (Canadian Pioneer Medical Technology Corporation). Cleared Apr 2024. https://www.510kdatabase.net/k232202/ 2024-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k232202-aperio-gt-450-dx-fda-510k.jpg K232202 - Aperio GT 450 DX K232202 is a FDA 510(k) cleared pathology medical device. Manufacturer: Leica Biosystems Imaging, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k232208/ 2024-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k232208-sectra-digital-pathology-module-fda-510k.jpg K232208 - Sectra Digital Pathology Module (Version 3.3) K232208 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sectra AB. Cleared Apr 2024. https://www.510kdatabase.net/k232256/ 2024-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k232256-alcantara-thoracolumbar-plate-system-fda-510k.jpg K232256 - Alcantara Thoracolumbar Plate System K232256 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Camber Spine Technologies, LLC. Cleared Apr 2024. https://www.510kdatabase.net/k233886/ 2024-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k233886-ambu-ascope-duodeno-2-ambu-abox-2-fda-510k.jpg K233886 - Ambu® aScope™ Duodeno 2, Ambu® aBox™ 2 K233886 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ambu A/S. Cleared Apr 2024. https://www.510kdatabase.net/k233962/ 2024-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k233962-reborn-1050nm-fda-510k.jpg K233962 - ReBorn (1050nm) K233962 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lightfective , Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k240748/ 2024-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k240748-nextaro-v-2020-fda-510k.jpg K240748 - nextaro® v, 20/20 K240748 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sfm Medical Devices GmbH. Cleared Apr 2024. https://www.510kdatabase.net/k223113/ 2024-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k223113-medentika-abutment-system-medentika-fda-510k.jpg K223113 - Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments K223113 is a FDA 510(k) cleared dental medical device. Manufacturer: Medentika GmbH. Cleared Apr 2024. https://www.510kdatabase.net/k232904/ 2024-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k232904-access-ostase-fda-510k.jpg K232904 - Access Ostase K232904 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter. Cleared Apr 2024. https://www.510kdatabase.net/k232926/ 2024-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k232926-novalung-ultimate-kit-us-fda-510k.jpg K232926 - Novalung ultimate kit (US) K232926 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC. Cleared Apr 2024. https://www.510kdatabase.net/k233411/ 2024-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k233411-folysil-silicone-catheter-fda-510k.jpg K233411 - Folysil Silicone Catheter K233411 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Coloplast Corp.. Cleared Apr 2024. https://www.510kdatabase.net/k240205/ 2024-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k240205-ez-catch-auto-fda-510k.jpg K240205 - Ez Catch Auto K240205 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Veol Medical Technologies Pvt , Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k240773/ 2024-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k240773-visableio-fda-510k.jpg K240773 - VisAble.IO K240773 is a FDA 510(k) cleared radiology medical device. Manufacturer: Techsomed. Cleared Apr 2024. https://www.510kdatabase.net/k240884/ 2024-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k240884-glide-91000-gl-x-fda-510k.jpg K240884 - Glide (91000-GL-X) K240884 is a FDA 510(k) cleared neurology medical device. Manufacturer: Infinite Biomedical Technologies, LLC. Cleared Apr 2024. https://www.510kdatabase.net/k232175/ 2024-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k232175-xn-knee-prosthesis-system-fda-510k.jpg K232175 - XN Knee Prosthesis System K232175 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Beijing Chunlizhengda Medical Instruments Co., Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k222766/ 2024-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k222766-disposable-extension-set-fda-510k.jpg K222766 - Disposable Extension Set K222766 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shandong Ande Healthcare Apparatus Co., Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k232060/ 2024-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k232060-tosama-reusable-applicator-fda-510k.jpg K232060 - TOSAMA Reusable Applicator K232060 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Tosama, D.O.O.. Cleared Apr 2024. https://www.510kdatabase.net/k232164/ 2024-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k232164-access-nt-probnp-fda-510k.jpg K232164 - Access NT-proBNP K232164 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k232200/ 2024-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k232200-disposable-injection-needles-fda-510k.jpg K232200 - Disposable Injection Needles K232200 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ningbo Xinwell Medical Technology Co., Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k232489/ 2024-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k232489-venusx-fda-510k.jpg K232489 - VenusX K232489 is a FDA 510(k) cleared radiology medical device. Manufacturer: Linatech, LLC. Cleared Apr 2024. https://www.510kdatabase.net/k232587/ 2024-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k232587-maglumi-25-oh-vitamin-d-maglumi-x3-fda-510k.jpg K232587 - MAGLUMI 25-OH Vitamin D, MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer K232587 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k232608/ 2024-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k232608-duo-hands-free-breast-pump-fda-510k.jpg K232608 - Duo Hands-free Breast Pump K232608 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Medela, LLC. Cleared Apr 2024. https://www.510kdatabase.net/k233034/ 2024-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k233034-mobility-enteral-feeding-system-otc-fda-510k.jpg K233034 - Mobility+ Enteral Feeding System OTC K233034 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Rockfield Medical. Cleared Apr 2024. https://www.510kdatabase.net/k233624/ 2024-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k233624-hcg-one-step-pregnancy-test-strip-otc-fda-510k.jpg K233624 - HCG One Step Pregnancy Test Strip OTC, HCG One Step Pregnancy Test Strip Rx, HCG One Step Pregnancy Test Midstream OTC, HCG One Step Pregnancy Test Midstream Rx K233624 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k240109/ 2024-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k240109-medical-electronic-thermometer-fc01-fc02-fda-510k.jpg K240109 - Medical electronic thermometer (FC01, FC02) K240109 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zhuzhou Goldenhot Medical Technology Co., Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k240238/ 2024-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k240238-vantage-fortianorian-15t-mrt-1550-v90-fda-510k.jpg K240238 - Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR K240238 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Apr 2024. https://www.510kdatabase.net/k240418/ 2024-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k240418-stryker-orthopaedics-hip-systems-fda-510k.jpg K240418 - Stryker Orthopaedics Hip Systems Labeling Update K240418 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp., Dba Stryker Orthopaedics. Cleared Apr 2024. https://www.510kdatabase.net/k240419/ 2024-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k240419-ultrathineer-zirconia-slurry-5y-b-fda-510k.jpg K240419 - UltraThineer Zirconia Slurry (5Y-B) K240419 is a FDA 510(k) cleared dental medical device. Manufacturer: Boston Micro Fabrication. Cleared Apr 2024. https://www.510kdatabase.net/k240452/ 2024-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k240452-ceramic-femoral-head-fda-510k.jpg K240452 - Ceramic Femoral Head K240452 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Microport Orthopedics, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k240571/ 2024-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k240571-oasis-mri-system-fda-510k.jpg K240571 - OASIS MRI System K240571 is a FDA 510(k) cleared radiology medical device. Manufacturer: Fujifilm Healthcare Corporation. Cleared Apr 2024. https://www.510kdatabase.net/k240686/ 2024-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k240686-healgen-accurate-urine-drug-screen-dip-fda-510k.jpg K240686 - Healgen Accurate Urine Drug Screen Dip Card K240686 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Healgen Scientific, LLC. Cleared Apr 2024. https://www.510kdatabase.net/k240703/ 2024-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k240703-fine-osteotomy-fda-510k.jpg K240703 - Fine Osteotomy™ K240703 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Bodycad Laboratories, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k202531/ 2024-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k202531-azer-scientific-universal-transport-fda-510k.jpg K202531 - Azer Scientific Universal Transport Medium K202531 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Azer Scientific, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k221847/ 2024-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k221847-ni2-implant-system-fda-510k.jpg K221847 - Ni2 Implant System K221847 is a FDA 510(k) cleared dental medical device. Manufacturer: Newton Implant Systems, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k232999/ 2024-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k232999-lyric4-hearing-aid-fda-510k.jpg K232999 - Lyric4 Hearing Aid K232999 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Sonova AG. Cleared Apr 2024. https://www.510kdatabase.net/k233698/ 2024-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k233698-true-enhance-dl-fda-510k.jpg K233698 - True Enhance DL K233698 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare Japan Corporation. Cleared Apr 2024. https://www.510kdatabase.net/k233757/ 2024-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k233757-titanpico-laser-workstation-pico-450-fda-510k.jpg K233757 - TitanPico Laser Workstation (PICO-450) K233757 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Rhein Laser Technologies Co., Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k240719/ 2024-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k240719-oc-juggerknot-soft-anchor-fda-510k.jpg K240719 - OC JuggerKnot Soft Anchor K240719 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Riverpoint Medical. Cleared Apr 2024. https://www.510kdatabase.net/k240720/ 2024-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k240720-tilink-p-si-joint-fusion-system-fda-510k.jpg K240720 - TiLink-P SI Joint Fusion System K240720 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SurGenTec, LLC. Cleared Apr 2024. https://www.510kdatabase.net/k232409/ 2024-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k232409-electromagnetic-stimulation-systems-fda-510k.jpg K232409 - Electromagnetic Stimulation Systems K232409 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Shanghai Apolo Medical Technology Co., Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k232523/ 2024-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k232523-sodium-chloride-inhalation-solution-fda-510k.jpg K232523 - Sodium Chloride Inhalation Solution, USP 0.9%, 3% & 7% K232523 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Mankind Pharma Limited. Cleared Apr 2024. https://www.510kdatabase.net/k232641/ 2024-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k232641-neorad-pacs-neorad-pacs-fda-510k.jpg K232641 - Neorad Pacs (Neorad Pacs) K232641 is a FDA 510(k) cleared radiology medical device. Manufacturer: Everrtech Software Pvt, Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k233313/ 2024-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k233313-keikku-electronic-stethoscope-fda-510k.jpg K233313 - Keikku Electronic stethoscope K233313 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Lapsi Health Holding B.V.. Cleared Apr 2024. https://www.510kdatabase.net/k233509/ 2024-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k233509-zavation-ibf-system-zavation-varisync-fda-510k.jpg K233509 - Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System K233509 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zavation Medical Products, LLC. Cleared Apr 2024. https://www.510kdatabase.net/k233561/ 2024-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k233561-3d-optical-coherence-tomography-3d-oct-fda-510k.jpg K233561 - 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) K233561 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Topcon Corporation. Cleared Apr 2024. https://www.510kdatabase.net/k233789/ 2024-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k233789-8q10-surclear-smoke-plume-evacuation-fda-510k.jpg K233789 - 8Q10 Surclear Smoke Plume Evacuation System K233789 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Surnic Corporation. Cleared Apr 2024. https://www.510kdatabase.net/k234057/ 2024-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k234057-nirvana-fda-510k.jpg K234057 - NIRVANA K234057 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: El.En S.P.A.. Cleared Apr 2024. https://www.510kdatabase.net/k240089/ 2024-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k240089-face-patches-mt-12ma-mt-12mc-fda-510k.jpg K240089 - Face Patches (MT-12MA, MT-12MC) K240089 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Kaiyan Medical Equipment Co., Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k240654/ 2024-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k240654-safecare-fentanyl-urine-test-cassette-fda-510k.jpg K240654 - SAFECARE Fentanyl Urine Test Cassette K240654 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Safecare Biotech (Hangzhou) Co., Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k240744/ 2024-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k240744-umr-680-fda-510k.jpg K240744 - uMR 680 K240744 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k240760/ 2024-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k240760-celerity-hp-indicator-tape-fda-510k.jpg K240760 - CELERITY HP Indicator Tape K240760 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Steris. Cleared Apr 2024. https://www.510kdatabase.net/k232147/ 2024-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k232147-caas-workstation-fda-510k.jpg K232147 - CAAS Workstation K232147 is a FDA 510(k) cleared radiology medical device. Manufacturer: Pie Medical Imaging BV. Cleared Apr 2024. https://www.510kdatabase.net/k232599/ 2024-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k232599-transform-mccarthy-mitral-annuloplasty-fda-510k.jpg K232599 - TransForm McCarthy Mitral Annuloplasty Ring (TF) K232599 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Genesee Biomedical, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k232623/ 2024-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k232623-universal-endometrial-applicator-set-fda-510k.jpg K232623 - Universal Endometrial Applicator Set (GM11009840) K232623 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k233263/ 2024-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k233263-disposable-trocars-fda-510k.jpg K233263 - Disposable Trocars K233263 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Hangzhou Kangji Medical Instrument Co., Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k233999/ 2024-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k233999-galaflex-lite-scaffold-fda-510k.jpg K233999 - GalaFLEX LITE Scaffold K233999 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Tepha, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/den230023/ 2024-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/den230023-rho-fda-510k.jpg DEN230023 - Rho DEN230023 is a FDA 510(k) cleared radiology medical device. Manufacturer: 16 Bit, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k212878/ 2024-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k212878-sample-preservation-solution-fda-510k.jpg K212878 - Sample preservation solution K212878 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Zhejiang Gene Science Co., Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k231728/ 2024-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k231728-biwaze-clear-system-fda-510k.jpg K231728 - BiWaze Clear System K231728 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Abmrc, LLC. Cleared Apr 2024. https://www.510kdatabase.net/k240021/ 2024-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k240021-powder-free-nitrile-examination-glove-fda-510k.jpg K240021 - Powder Free Nitrile Examination Glove 3.5, Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate K240021 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Yue Kang Anhui Medical Products Co., Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k240291/ 2024-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k240291-efai-cardiosuite-cta-acute-aortic-fda-510k.jpg K240291 - EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM K240291 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ever Fortune.Ai, Co., Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k240423/ 2024-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k240423-tdm-anterior-cervical-plate-system-fda-510k.jpg K240423 - TDM Anterior Cervical Plate System K240423 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tdm Co., Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k223914/ 2024-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k223914-activ-cap-fda-510k.jpg K223914 - ACTIV™ Cap K223914 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cleansite Medical, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k232103/ 2024-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k232103-terragene-chemdye-multivariable-fda-510k.jpg K232103 - Terragene® Chemdye® Multivariable Chemical Indicator (CD40), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40) K232103 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terragene S.A.. Cleared Apr 2024. https://www.510kdatabase.net/k232115/ 2024-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k232115-tdm-large-bone-plate-and-screw-system-fda-510k.jpg K232115 - TDM Large Bone Plate and Screw System K232115 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tdm Co., Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k232792/ 2024-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k232792-icotec-interbody-cage-system-icotec-fda-510k.jpg K232792 - icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn™ TLIF Lumbar Cage) K232792 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Icotec AG. Cleared Apr 2024. https://www.510kdatabase.net/k232823/ 2024-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k232823-mcg-s-am1000-fda-510k.jpg K232823 - MCG-S (AM1000) K232823 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Amcg Co., Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k232919/ 2024-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k232919-ambu-ascope-gastro-large-fda-510k.jpg K232919 - Ambu® aScope™ Gastro Large K232919 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ambu A/S. Cleared Apr 2024. https://www.510kdatabase.net/k233192/ 2024-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k233192-wireless-smart-thermometer-fda-510k.jpg K233192 - Wireless Smart Thermometer K233192 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Famidoc Technology Company Limited. Cleared Apr 2024. https://www.510kdatabase.net/k233249/ 2024-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k233249-appraise-hri-fda-510k.jpg K233249 - APPRAISE-HRI K233249 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: The Surgeon General, Department of the Army (TSG-DA). Cleared Apr 2024. https://www.510kdatabase.net/k233666/ 2024-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k233666-corvista-system-with-ph-add-on-fda-510k.jpg K233666 - CorVista System with PH Add-On K233666 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Analytics For Life, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k233779/ 2024-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k233779-loopview-single-use-digital-flexible-fda-510k.jpg K233779 - LoopView® Single-Use Digital Flexible Bronchoscope (B38, B38-C, B50, B50-C, B58, B58-C), ViewHub® Video Processor (S13) K233779 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: MacroLux Medical Technology Co., Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k233935/ 2024-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k233935-digiline-direct-print-aligner-system-fda-510k.jpg K233935 - DigiLine Direct Print Aligner System K233935 is a FDA 510(k) cleared dental medical device. Manufacturer: Park Dental Research Corporation. Cleared Apr 2024. https://www.510kdatabase.net/k234105/ 2024-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k234105-catalyst-f1x-shoulder-system-fda-510k.jpg K234105 - Catalyst F1x Shoulder System K234105 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Catalyst Orthoscience, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k234152/ 2024-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k234152-aceso-early-pregnancy-test-fda-510k.jpg K234152 - ACESO Early Pregnancy Test K234152 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Aceso Laboratories, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k240360/ 2024-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k240360-wrinkle-treatment-device-jm2-fda-510k.jpg K240360 - Wrinkle Treatment Device (JM2) K240360 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Qianyu Technology Co., Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k240647/ 2024-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k240647-virage-navigation-system-fda-510k.jpg K240647 - Virage® Navigation System K240647 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimvie Spine (Zimmer Biomet Spine, Inc.). Cleared Apr 2024. https://www.510kdatabase.net/k240737/ 2024-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k240737-g-surgical-marksman-mis-system-fda-510k.jpg K240737 - G Surgical Marksman MIS System K240737 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: G Surgical, LLC. Cleared Apr 2024. https://www.510kdatabase.net/den210058/ 2024-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/den210058-eleosx-limb-salvage-system-fda-510k.jpg DEN210058 - ELEOSx™ Limb Salvage System DEN210058 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Onkos Surgical. Cleared Apr 2024. https://www.510kdatabase.net/den220015/ 2024-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/den220015-orthobond-mariner-pedicle-screw-system-fda-510k.jpg DEN220015 - Orthobond Mariner Pedicle Screw System DEN220015 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthobond Coporation. Cleared Apr 2024. https://www.510kdatabase.net/den230032/ 2024-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/den230032-symani-surgical-system-fda-510k.jpg DEN230032 - Symani Surgical System DEN230032 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Mmi North America, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k231834/ 2024-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k231834-vsp-peek-cranial-implant-fda-510k.jpg K231834 - VSP PEEK Cranial Implant K231834 is a FDA 510(k) cleared neurology medical device. Manufacturer: 3D Systems, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k232027/ 2024-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k232027-capi-3-neonat-hb-capillarys-3-dbs-fda-510k.jpg K232027 - CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument K232027 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sebia. Cleared Apr 2024. https://www.510kdatabase.net/k232037/ 2024-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k232037-reprocessed-versacross-steerable-sheath-fda-510k.jpg K232037 - Reprocessed VersaCross Steerable Sheath K232037 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Innovative Health, LLC. Cleared Apr 2024. https://www.510kdatabase.net/k232114/ 2024-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k232114-tribrid-unicompartmental-knee-system-fda-510k.jpg K232114 - TRIBRID® Unicompartmental Knee System K232114 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Kyocera Medical Technologies, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k232227/ 2024-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k232227-ablate-iq-fda-510k.jpg K232227 - ABLATE-IQ K232227 is a FDA 510(k) cleared radiology medical device. Manufacturer: Neuwave Medical, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k232790/ 2024-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k232790-kong-tl-vbr-system-and-kong-c-vbr-system-fda-510k.jpg K232790 - KONG®-TL VBR System and KONG® C VBR System K232790 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Icotec AG. Cleared Apr 2024. https://www.510kdatabase.net/k233026/ 2024-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k233026-midmark-smart-m9-sterilizer-midmark-fda-510k.jpg K233026 - Midmark Smart M9® Sterilizer, Midmark Smart M11® Sterilizer K233026 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Midmark Corporation. Cleared Apr 2024. https://www.510kdatabase.net/k233050/ 2024-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k233050-advia-centaur-tsh3-ultra-ii-tsh3ulii-fda-510k.jpg K233050 - ADVIA Centaur® TSH3-Ultra II (TSH3ULII) K233050 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k233837/ 2024-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k233837-agile-esophageal-stent-system-fda-510k.jpg K233837 - Agile Esophageal Stent System K233837 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Apr 2024. https://www.510kdatabase.net/k233910/ 2024-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k233910-vertex-hip-fracture-nailing-system-fda-510k.jpg K233910 - Vertex Hip Fracture Nailing System K233910 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthoxel Dac. Cleared Apr 2024. https://www.510kdatabase.net/k240038/ 2024-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k240038-clear-moves-aligners-fda-510k.jpg K240038 - Clear Moves Aligners K240038 is a FDA 510(k) cleared dental medical device. Manufacturer: Space Maintainers Laboratories (Sml). Cleared Apr 2024. https://www.510kdatabase.net/k240071/ 2024-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k240071-peleton-universal-single-use-power-fda-510k.jpg K240071 - Peleton Universal Single Use Power System and Attachments K240071 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Peleton Surgical. Cleared Apr 2024. https://www.510kdatabase.net/k240172/ 2024-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k240172-preview-shoulder-fda-510k.jpg K240172 - Preview Shoulder K240172 is a FDA 510(k) cleared radiology medical device. Manufacturer: Genesis Software Innovations. Cleared Apr 2024. https://www.510kdatabase.net/k240361/ 2024-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k240361-powder-free-green-nitrile-examination-fda-510k.jpg K240361 - Powder Free Green Nitrile Examination Gloves (XS/S/M/L/XL) K240361 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hebei Titans Hongsen Medical Technology Co., Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k240639/ 2024-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k240639-pinnacletm-constrained-acetabular-liners-fda-510k.jpg K240639 - PINNACLETM Constrained Acetabular Liners K240639 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Ireland UC. Cleared Apr 2024. https://www.510kdatabase.net/k240652/ 2024-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k240652-ice-cooling-ipl-hair-removal-device-fda-510k.jpg K240652 - Ice Cooling IPL Hair Removal Device (UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG,UI06 RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY, UI06 IG, UIM20 GR, UIM20 BK, UIM20 SL, UIM20 CB, UIM20 WR) K240652 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Ulike Smart Electronics Co., Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k230889/ 2024-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k230889-digital-thermometer-fda-510k.jpg K230889 - Digital Thermometer K230889 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wenzhou Yosun Medical Technology Co.,Ltd. Cleared Apr 2024. https://www.510kdatabase.net/k232653/ 2024-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k232653-blue-sky-plan-software-blue-sky-bio-fda-510k.jpg K232653 - Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX K232653 is a FDA 510(k) cleared dental medical device. Manufacturer: Blue Sky Bio, LLC. Cleared Apr 2024. https://www.510kdatabase.net/k232899/ 2024-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k232899-ai-rad-companion-organs-rt-fda-510k.jpg K232899 - AI-Rad Companion Organs RT K232899 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions U.S.A.. Cleared Apr 2024. https://www.510kdatabase.net/k233548/ 2024-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k233548-uresta-fda-510k.jpg K233548 - Uresta® K233548 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Resilia, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k233618/ 2024-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k233618-oxevision-sleep-device-fda-510k.jpg K233618 - Oxevision Sleep Device K233618 is a FDA 510(k) cleared neurology medical device. Manufacturer: Oxehealth Limited. Cleared Apr 2024. https://www.510kdatabase.net/k240135/ 2024-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k240135-ion-endoluminal-system-ion-fully-fda-510k.jpg K240135 - Ion™ Endoluminal System (Ion™ Fully Articulating Catheter) (IF1000) K240135 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k240282/ 2024-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k240282-ipl-hair-removal-device-model-kca450-fda-510k.jpg K240282 - IPL Hair Removal Device (model: KCA450, KCA446, KCA504, KCA505, KCA506, KCA507, KCA508, KCA509, KCA501, KCA423, KCA448, KCA449, KCA502, KCA521) K240282 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Dongguan Boyuan Intelligent Technology Co.,Ltd. Cleared Apr 2024. https://www.510kdatabase.net/k240350/ 2024-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k240350-anyplus-ii-spinal-fixation-system-fda-510k.jpg K240350 - AnyPlus II Spinal Fixation System K240350 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: GS Medical Co., Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k240618/ 2024-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k240618-acuity-200-fluoroxyfocon-a-rigid-gas-fda-510k.jpg K240618 - Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens K240618 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Acuity Polymers, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k211815/ 2024-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k211815-lifescale-gram-negative-kit-lsgn-with-fda-510k.jpg K211815 - LifeScale Gram Negative Kit (LSGN) with the LifeScale AST System K211815 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Affinity Biosensors. Cleared Apr 2024. https://www.510kdatabase.net/k232112/ 2024-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k232112-rg-surgical-mask-fda-510k.jpg K232112 - R&G Surgical Mask K232112 is a FDA 510(k) cleared general hospital medical device. Manufacturer: R&G Seguridad E Higiene Industrial S.A.C.. Cleared Apr 2024. https://www.510kdatabase.net/k232835/ 2024-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k232835-aquilion-one-tsx-308a3-v14-with-piqe-fda-510k.jpg K232835 - Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System K232835 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Apr 2024. https://www.510kdatabase.net/k233750/ 2024-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k233750-ecg-less-cardiac-fda-510k.jpg K233750 - ECG-less Cardiac K233750 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems, LLC. Cleared Apr 2024. https://www.510kdatabase.net/k233975/ 2024-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k233975-zoom-6f-insert-catheters-fda-510k.jpg K233975 - Zoom 6F Insert Catheters K233975 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Imperative Care, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k240080/ 2024-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k240080-aloe-vera-nitrile-examination-gloves-fda-510k.jpg K240080 - Aloe Vera Nitrile Examination Gloves (Green) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate K240080 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Syntex Healthcare Products Co., Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k240601/ 2024-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k240601-snapshotnir-model-kd205-fda-510k.jpg K240601 - SnapshotNIR model KD205 K240601 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Kent Imaging, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k240888/ 2024-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k240888-calibra-abutment-resin-cement-fda-510k.jpg K240888 - Calibra Abutment Resin Cement K240888 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona. Cleared Apr 2024. https://www.510kdatabase.net/den230036/ 2024-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/den230036-sepsis-immunoscore-fda-510k.jpg DEN230036 - Sepsis ImmunoScore DEN230036 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Prenosis, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k230895/ 2024-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k230895-cefla-dental-micromotors-i-mmr-i-mmr-l-fda-510k.jpg K230895 - CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO K230895 is a FDA 510(k) cleared dental medical device. Manufacturer: Cefla S.C.. Cleared Apr 2024. https://www.510kdatabase.net/k232726/ 2024-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k232726-external-hex-implant-system-fda-510k.jpg K232726 - External Hex Implant System K232726 is a FDA 510(k) cleared dental medical device. Manufacturer: Southern Implants (Pty), Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k233133/ 2024-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k233133-talis-emr-with-talis-acg-talis-emr-fda-510k.jpg K233133 - Talis EMR with Talis +ACG (Talis EMR with +ACG) K233133 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Talis Clinical, LLC. Cleared Apr 2024. https://www.510kdatabase.net/k233676/ 2024-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k233676-us2v2-fda-510k.jpg K233676 - Us2.v2 K233676 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eko.Ai Pte Ltd. D/B/A Us2.Ai. Cleared Apr 2024. https://www.510kdatabase.net/k233990/ 2024-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k233990-nitrile-disposable-examination-gloves-fda-510k.jpg K233990 - Nitrile Disposable Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl (D5000) K233990 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shandong Xingyu Gloves Co., Ltd.. Cleared Apr 2024. https://www.510kdatabase.net/k240043/ 2024-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k240043-evolution-hinge-knee-system-fda-510k.jpg K240043 - EVOLUTION® Hinge Knee System K240043 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Microport Orthopedics, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k240288/ 2024-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k240288-sf-push-in-anchor-fda-510k.jpg K240288 - SF Push- in Anchor K240288 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Surgical Fusion Technologies GmbH. Cleared Apr 2024. https://www.510kdatabase.net/k240397/ 2024-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k240397-alphavac-mma-f1885-system-h787253020-fda-510k.jpg K240397 - AlphaVac MMA F1885 System (H787253020) K240397 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: AngioDynamics, Inc.. Cleared Apr 2024. https://www.510kdatabase.net/k240442/ 2024-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k240442-magnetos-putty-fda-510k.jpg K240442 - MagnetOs Putty K240442 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Kuros Biosciences B.V. Cleared Apr 2024. https://www.510kdatabase.net/k240635/ 2024-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k240635-endocollect-specimen-retrieval-bag-8mm-fda-510k.jpg K240635 - ENDOCOLLECT Specimen Retrieval Bag, 8mm, ENDOCOLLECT Specimen Retrieval Bag, 12mm, ENDOCOLLECT Specimen Retrieval Bag, 15mm K240635 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ximedica. Cleared Apr 2024. https://www.510kdatabase.net/k231209/ 2024-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k231209-rejoyn-fda-510k.jpg K231209 - Rejoyn K231209 is a FDA 510(k) cleared neurology medical device. Manufacturer: Otsuka America Pharmaceutical, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k211122/ 2024-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k211122-novum-iq-large-volume-pump-fda-510k.jpg K211122 - Novum IQ Large Volume Pump K211122 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corporation. Cleared Mar 2024. https://www.510kdatabase.net/k230665/ 2024-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k230665-dose-iq-safety-software-fda-510k.jpg K230665 - Dose IQ Safety Software K230665 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corporation. Cleared Mar 2024. https://www.510kdatabase.net/k232018/ 2024-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k232018-citrated-k-kh-rth-ffh-fda-510k.jpg K232018 - Citrated: K, KH, RTH, FFH K232018 is a FDA 510(k) cleared hematology medical device. Manufacturer: Haemonetics Corporation. Cleared Mar 2024. https://www.510kdatabase.net/k232031/ 2024-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k232031-luna-3d-fda-510k.jpg K232031 - LUNA 3D K232031 is a FDA 510(k) cleared radiology medical device. Manufacturer: Lap GmbH Laser Applikationen. Cleared Mar 2024. https://www.510kdatabase.net/k232825/ 2024-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k232825-disposable-sphincterotome-fda-510k.jpg K232825 - Disposable Sphincterotome K232825 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Jiangsu Vedkang Medical Science and Technology Co., Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k233068/ 2024-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k233068-disposable-surgical-gown-fda-510k.jpg K233068 - Disposable Surgical Gown K233068 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Nanning Tecbod Biological Technology Co., Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k233211/ 2024-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k233211-aview-cac-fda-510k.jpg K233211 - AVIEW CAC K233211 is a FDA 510(k) cleared radiology medical device. Manufacturer: Coreline Soft Co., Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k233595/ 2024-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k233595-genesys-spine-sacroiliac-joint-fusion-fda-510k.jpg K233595 - Genesys Spine Sacroiliac Joint Fusion System with Navigation K233595 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Genesys Spine. Cleared Mar 2024. https://www.510kdatabase.net/k233622/ 2024-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k233622-alignrt-plus-fda-510k.jpg K233622 - AlignRT Plus K233622 is a FDA 510(k) cleared radiology medical device. Manufacturer: Vision Rt, Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k240310/ 2024-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k240310-lcd-monitors-c310s-g310s-c316s-g316s-fda-510k.jpg K240310 - LCD Monitors C310S, G310S, C316S, G316S, C616W K240310 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Beacon Display Technology Co., Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k240587/ 2024-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k240587-smoothskin-pure-unplugged-ssb3-fda-510k.jpg K240587 - SmoothSkin Pure Unplugged (SSB3) K240587 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cyden Limited. Cleared Mar 2024. https://www.510kdatabase.net/k240608/ 2024-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k240608-magnetom-viatomobile-fda-510k.jpg K240608 - MAGNETOM Viato.Mobile K240608 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k231972/ 2024-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k231972-advanta-vxt-vascular-graft-flixene-fda-510k.jpg K231972 - Advanta VXT Vascular Graft, Flixene Vascular Graft K231972 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Atrium Medical Corporation. Cleared Mar 2024. https://www.510kdatabase.net/k232013/ 2024-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k232013-aperta-nse-pta-balloon-dilatation-fda-510k.jpg K232013 - Aperta NSE PTA Balloon Dilatation Catheter (AW18-05040040/AA18-05040040, AW18-09040040/AA18-09040040, AW18-14540040, AW18-05050040/AA18-05050040, AW18-09050040/AA18-09050040, AW18-14550040, AW18-05060040/AA18-05060040, AW18-09060040/AA18-09060040, AW18-14560040 AW18-05070040/AA18-05070040, AW18-09070040/AA18-09070040, AW18-14570040, AW18-05080040/AA18-05080040, AW18-09080040/AA18-09080040, AW18-14580040) K232013 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Goodman Co., Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k232047/ 2024-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k232047-vivace-fda-510k.jpg K232047 - VIVACE K232047 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Unimom.Co. Cleared Mar 2024. https://www.510kdatabase.net/k232049/ 2024-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k232049-is-iii-active-short-implant-fda-510k.jpg K232049 - IS-III active Short Implant K232049 is a FDA 510(k) cleared dental medical device. Manufacturer: Neobiotech Co., Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k232079/ 2024-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k232079-natural-rubber-latex-surgical-glove-fda-510k.jpg K232079 - Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green) K232079 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wrp Asia Pacific Sdn. Bhd.. Cleared Mar 2024. https://www.510kdatabase.net/k233409/ 2024-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k233409-eko-low-ejection-fraction-tool-eleft-fda-510k.jpg K233409 - Eko Low Ejection Fraction Tool (ELEFT) K233409 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Eko Health, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k233604/ 2024-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k233604-btl-785s-fda-510k.jpg K233604 - BTL-785S K233604 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: BTL Industries, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k233609/ 2024-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k233609-core-500-digital-stethoscope-fda-510k.jpg K233609 - CORE 500 Digital Stethoscope K233609 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Eko Health, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k233657/ 2024-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k233657-naeotom-alpha-fda-510k.jpg K233657 - NAEOTOM Alpha K233657 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k233669/ 2024-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k233669-oec-3d-fda-510k.jpg K233669 - OEC 3D K233669 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Oec Medical Systems, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k233719/ 2024-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k233719-fdr-visionary-suite-fda-510k.jpg K233719 - FDR Visionary Suite K233719 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shimadzu Corporation. Cleared Mar 2024. https://www.510kdatabase.net/k233838/ 2024-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k233838-emprint-ablation-system-with-fda-510k.jpg K233838 - Emprint Ablation System with Thermosphere Technology (Overall System Name) K233838 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medtronic, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k233909/ 2024-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k233909-cleaner-plus-18f-thrombectomy-system-fda-510k.jpg K233909 - Cleaner™ Plus 18F Thrombectomy System - Cleaner™ Plus 18F Aspiration Catheter, Cleaner™ Plus 18F Handpiece with Maceration Wire, Cleaner™ Plus 18F Aspiration Canister K233909 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Argon Medical Devices, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k240171/ 2024-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k240171-proseal-injector-plus-model-no-421050-fda-510k.jpg K240171 - ProSeal™ Injector Plus (Model no. 421050) K240171 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Epic Medical Pte. , Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k240284/ 2024-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k240284-digital-radiography-system-mobileapex-fda-510k.jpg K240284 - Digital Radiography System (MobileApex 60E, MobileApex 60F, MobileApex 60G, MobileApex 60H) K240284 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Browiner Tech Co., Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k240295/ 2024-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k240295-instastrip-fentanyl-rapid-test-urine-fda-510k.jpg K240295 - InstaStrip Fentanyl Rapid Test (Urine) K240295 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Instanosis, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k240567/ 2024-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k240567-customizedbone-service-fda-510k.jpg K240567 - CustomizedBone Service K240567 is a FDA 510(k) cleared neurology medical device. Manufacturer: Fin-Ceramica Faenza S.P.A.. Cleared Mar 2024. https://www.510kdatabase.net/k240693/ 2024-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k240693-linq-ii-insertable-cardiac-monitor-icm-fda-510k.jpg K240693 - LINQ II™ Insertable Cardiac Monitor (ICM) K240693 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k222613/ 2024-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k222613-arx-liquid-amies-collection-transport-fda-510k.jpg K222613 - ARX Liquid Amies Collection & Transport System K222613 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Arx Sciences, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k223360/ 2024-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k223360-luofucon-silicone-ag-foam-dressing-fda-510k.jpg K223360 - LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing K223360 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Huizhou Foryou Medical Devices Co., Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k231425/ 2024-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k231425-transcutaneous-electrical-nerve-fda-510k.jpg K231425 - Transcutaneous Electrical Nerve Stimulator (TENS WMPS2-1) K231425 is a FDA 510(k) cleared neurology medical device. Manufacturer: Wuxi Jiajian Medical Instrument Co., Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k232253/ 2024-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k232253-modius-stress-fda-510k.jpg K232253 - Modius Stress K232253 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neurovalens Limited. Cleared Mar 2024. https://www.510kdatabase.net/k232891/ 2024-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k232891-carpl-carpl-fda-510k.jpg K232891 - CARPL (CARPL) K232891 is a FDA 510(k) cleared radiology medical device. Manufacturer: Carpl Ai, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k233201/ 2024-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k233201-midway-delivery-catheter-midway-43-fda-510k.jpg K233201 - MIDWAY Delivery Catheter (MIDWAY 43 Delivery Catheter K233201 is a FDA 510(k) cleared neurology medical device. Manufacturer: Penumbra, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k233539/ 2024-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k233539-mammomat-bbrilliant-fda-510k.jpg K233539 - MAMMOMAT B.brilliant K233539 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k233951/ 2024-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k233951-cd-horizon-modulex-spinal-system-fda-510k.jpg K233951 - CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) K233951 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k233989/ 2024-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k233989-carboclear-posterior-cervical-screw-fda-510k.jpg K233989 - CarboClear® Posterior Cervical Screw System K233989 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: CarboFix Orthopedics , Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k234097/ 2024-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k234097-disposable-powder-free-nitrile-fda-510k.jpg K234097 - Disposable Powder Free Nitrile Examination Glove, Natural Blue Color, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate K234097 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ever Growth (Vietnam) Corporation Limited. Cleared Mar 2024. https://www.510kdatabase.net/k234143/ 2024-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k234143-i-stat-tbi-cartridge-with-the-i-stat-fda-510k.jpg K234143 - i-STAT TBI Cartridge with the i-STAT Alinity System K234143 is a FDA 510(k) cleared immunology medical device. Manufacturer: Abbott Point of Care. Cleared Mar 2024. https://www.510kdatabase.net/k234150/ 2024-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k234150-lucent-xp-fda-510k.jpg K234150 - Lucent® XP K234150 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinal Elements. Cleared Mar 2024. https://www.510kdatabase.net/k240045/ 2024-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k240045-qstat-cartridge-fda-510k.jpg K240045 - QStat Cartridge K240045 is a FDA 510(k) cleared hematology medical device. Manufacturer: Hemosonics, LLC. Cleared Mar 2024. https://www.510kdatabase.net/k240389/ 2024-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k240389-secret-line-up-fcl18100c160-fda-510k.jpg K240389 - Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ) K240389 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Hyundae Meditech Co., Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/den210049/ 2024-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/den210049-medline-art-skin-harvesting-system-fda-510k.jpg DEN210049 - Medline ART Skin Harvesting System DEN210049 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medline Industries, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k231132/ 2024-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k231132-j-p-click-attachments-fda-510k.jpg K231132 - J & P Click Attachments K231132 is a FDA 510(k) cleared dental medical device. Manufacturer: J & P Dental Technologies. Cleared Mar 2024. https://www.510kdatabase.net/k231793/ 2024-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k231793-rodin-3d-resin-splint-hardflex-fda-510k.jpg K231793 - RODIN 3D Resin SPLINT, Hard/Flex K231793 is a FDA 510(k) cleared dental medical device. Manufacturer: Belport Company, Inc., Gingi-Pak. Cleared Mar 2024. https://www.510kdatabase.net/k231984/ 2024-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k231984-clinical-automatic-blood-pressure-fda-510k.jpg K231984 - Clinical Automatic Blood Pressure Monitor (DBP-01P,DBP-01HP) K231984 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Hingmed Medical Instrument Co., Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k232954/ 2024-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k232954-biofire-spotfire-respiratorysore-fda-510k.jpg K232954 - BIOFIRE SPOTFIRE Respiratory/Sore Throat (R/ST) Panel K232954 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Biofire Diagnostics, LLC. Cleared Mar 2024. https://www.510kdatabase.net/k233069/ 2024-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k233069-removal-system-large-bore-60-cc-syringe-fda-510k.jpg K233069 - Removal System Large Bore 60 cc Syringe K233069 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Inari Medical, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k233151/ 2024-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k233151-plurogel-antimicrobial-burn-and-wound-fda-510k.jpg K233151 - PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC) K233151 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medline Industries, LP. Cleared Mar 2024. https://www.510kdatabase.net/k233611/ 2024-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k233611-spotfire-rsp-pos-neg-controls-m425-fda-510k.jpg K233611 - SPOTFIRE RSP Pos & Neg Controls (M425), SPOTFIRE RSP Positive Control (M42638), SPOTFIRE RSP Negative Control (M42738) K233611 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Maine Molecular Quality Controls, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k233650/ 2024-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k233650-somatom-goup-fda-510k.jpg K233650 - SOMATOM go.Up K233650 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k233733/ 2024-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k233733-symri-fda-510k.jpg K233733 - SyMRI K233733 is a FDA 510(k) cleared radiology medical device. Manufacturer: Syntheticmr AB (Publ.). Cleared Mar 2024. https://www.510kdatabase.net/k240594/ 2024-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k240594-grappler-suture-anchor-r3flex-iol-system-fda-510k.jpg K240594 - Grappler Suture Anchor R3FLEX IOL System K240594 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paragon 28, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k231986/ 2024-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k231986-modus-ir-fda-510k.jpg K231986 - Modus IR K231986 is a FDA 510(k) cleared neurology medical device. Manufacturer: Synaptive Medical, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k232268/ 2024-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k232268-steri-oss-implant-system-fda-510k.jpg K232268 - STERI-OSS Implant System K232268 is a FDA 510(k) cleared dental medical device. Manufacturer: Zeros Co., Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k233167/ 2024-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k233167-lw-implant-system-abutment-fda-510k.jpg K233167 - LW Implant System – Abutment K233167 is a FDA 510(k) cleared dental medical device. Manufacturer: Ossvis Co., Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k233275/ 2024-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k233275-renaflex-single-use-flexible-fda-510k.jpg K233275 - RenaFlex Single-use Flexible Ureteroscope (SUURF-V Standard) K233275 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Gyrus Acmi, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k233919/ 2024-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k233919-variax-2-distal-radius-system-fda-510k.jpg K233919 - VariAx 2 Distal Radius System K233919 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker GmbH. Cleared Mar 2024. https://www.510kdatabase.net/k234080/ 2024-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k234080-mega-iom-system-with-neuro-iomnet-fda-510k.jpg K234080 - MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) K234080 is a FDA 510(k) cleared neurology medical device. Manufacturer: Soterix Medical, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k234085/ 2024-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k234085-lune-purehygiene-fda-510k.jpg K234085 - LUNE™ PureHygiene K234085 is a FDA 510(k) cleared dental medical device. Manufacturer: Enamel Pure. Cleared Mar 2024. https://www.510kdatabase.net/k240292/ 2024-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k240292-transcutaneous-electrical-nerve-fda-510k.jpg K240292 - Transcutaneous Electrical Nerve Stimulator (9029SCM) K240292 is a FDA 510(k) cleared neurology medical device. Manufacturer: Hong Kong Etech Groups Limited. Cleared Mar 2024. https://www.510kdatabase.net/k240329/ 2024-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k240329-electric-wheelchair-yhw001-c-fda-510k.jpg K240329 - Electric wheelchair (YHW001-C K240329 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Yongkang Youha Electric Appliance Co., Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k240589/ 2024-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k240589-micropuncture-introducer-sets-fda-510k.jpg K240589 - Micropuncture Introducer Sets K240589 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Medical. Cleared Mar 2024. https://www.510kdatabase.net/k240620/ 2024-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k240620-cube-navigator-fda-510k.jpg K240620 - Cube Navigator K240620 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medical Templates AG. Cleared Mar 2024. https://www.510kdatabase.net/k231795/ 2024-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k231795-quickvue-covid-19-test-fda-510k.jpg K231795 - QuickVue COVID-19 Test K231795 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Quidel Corporation. Cleared Mar 2024. https://www.510kdatabase.net/k231806/ 2024-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k231806-thermo-scientific-oxoid-rezafungin-fda-510k.jpg K231806 - Thermo Scientific Oxoid Rezafungin Disc (5 µg) RZF5 K231806 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Oxoid Limited (Part of Thermo Fisher Scientific). Cleared Mar 2024. https://www.510kdatabase.net/k231926/ 2024-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k231926-neurostar-advanced-therapy-system-all-fda-510k.jpg K231926 - NeuroStar Advanced Therapy System (All previously cleared models) K231926 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neuronetics, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k231927/ 2024-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k231927-elecsys-pth-elecsys-pth-stat-fda-510k.jpg K231927 - Elecsys PTH , Elecsys PTH STAT K231927 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Mar 2024. https://www.510kdatabase.net/k231930/ 2024-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k231930-digital-ultrasonic-diagnostic-imaging-fda-510k.jpg K231930 - Digital Ultrasonic Diagnostic Imaging System (Model: F6) K231930 is a FDA 510(k) cleared radiology medical device. Manufacturer: Guangdong Youkey Medical Co., Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k231938/ 2024-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k231938-halyard-sterling-nitrile-powder-free-fda-510k.jpg K231938 - Halyard STERLING* Nitrile Powder-Free Exam Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, Fentanyl Citrate and Gastric Acid K231938 is a FDA 510(k) cleared general hospital medical device. Manufacturer: O&M Halyard, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k231953/ 2024-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k231953-biatain-fiber-ag-33570-5-cm-x-5-cm-2-fda-510k.jpg K231953 - Biatain Fiber Ag (33570 - 5 cm x 5 cm / 2 in x 2 in) K231953 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Coloplast Corp.. Cleared Mar 2024. https://www.510kdatabase.net/k232067/ 2024-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k232067-defendo-fujifilm-500600-single-use-fda-510k.jpg K232067 - Defendo Fujifilm 500/600 Single Use Air/Water Valve, Defendo Fujifilm 500/600 Single Use Suction Valve, Defendo Fujifilm 500/600 Single Use Biopsy Valve, Endogator Fujifilm 500/600 Single Use Connector K232067 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medivators (A Subsidiary of Steris Corporation). Cleared Mar 2024. https://www.510kdatabase.net/k232169/ 2024-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k232169-fitbone-transport-and-lengthening-system-fda-510k.jpg K232169 - FITBONE® Transport and Lengthening System K232169 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthofix Srl. Cleared Mar 2024. https://www.510kdatabase.net/k232282/ 2024-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k232282-aprevo-anterior-and-lateral-lumbar-fda-510k.jpg K232282 - aprevo® anterior and lateral lumbar interbody fusion device, aprevo® transforaminal lumbar interbody fusion device K232282 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Carlsmed, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k232322/ 2024-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k232322-magnetom-terra-fda-510k.jpg K232322 - MAGNETOM Terra K232322 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k232354/ 2024-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k232354-vios-monitoring-systemtm-model-2050-fda-510k.jpg K232354 - Vios Monitoring System(TM) Model 2050 K232354 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Murata Vios, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k232431/ 2024-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k232431-syngoct-brain-hemorrhage-fda-510k.jpg K232431 - syngo.CT Brain Hemorrhage K232431 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k232548/ 2024-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k232548-corsano-cardiowatch-287-2-system-fda-510k.jpg K232548 - Corsano CardioWatch 287-2 System K232548 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Corsano Health B.V.. Cleared Mar 2024. https://www.510kdatabase.net/k232920/ 2024-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k232920-relief-ureteral-stent-kit-fda-510k.jpg K232920 - RELIEF™ Ureteral Stent Kit K232920 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ureteral Stent Company. Cleared Mar 2024. https://www.510kdatabase.net/k233148/ 2024-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k233148-augment-off-axis-instrument-system-fda-510k.jpg K233148 - Augment Off-Axis Instrument System K233148 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Fix Surgical. Cleared Mar 2024. https://www.510kdatabase.net/k233262/ 2024-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k233262-dukal-sms-sterilization-wrap-fda-510k.jpg K233262 - Dukal SMS Sterilization Wrap K233262 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Dukal, LLC. Cleared Mar 2024. https://www.510kdatabase.net/k233441/ 2024-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k233441-the-vest-apx-system-pvapx1-fda-510k.jpg K233441 - The Vest APX System (PVAPX1) K233441 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Baxter Healthcare Corportation. Cleared Mar 2024. https://www.510kdatabase.net/k233569/ 2024-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k233569-septalign-fda-510k.jpg K233569 - SeptAlign K233569 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Spirair, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k233578/ 2024-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k233578-bahadir-sterilization-containers-fda-510k.jpg K233578 - BAHADIR STERILIZATION CONTAINERS K233578 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bahadir USA, LLC. Cleared Mar 2024. https://www.510kdatabase.net/k233713/ 2024-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k233713-pilling-tracheostomy-tubes-fda-510k.jpg K233713 - Pilling Tracheostomy Tubes K233713 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Teleflex Medical. Cleared Mar 2024. https://www.510kdatabase.net/k240225/ 2024-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k240225-shockwave-intravascular-lithotripsy-fda-510k.jpg K240225 - Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL Catheter K240225 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shockwave Medical, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k240522/ 2024-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k240522-esophageal-tts-stent-fda-510k.jpg K240522 - Esophageal TTS Stent K240522 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Taewoong Medical. Cleared Mar 2024. https://www.510kdatabase.net/k240540/ 2024-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k240540-umr-omega-fda-510k.jpg K240540 - uMR Omega K240540 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k240690/ 2024-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k240690-struxxure-mcs-anterior-cervical-plate-fda-510k.jpg K240690 - STRUXXURE® MCS Anterior Cervical Plate System K240690 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nexxt Spine. Cleared Mar 2024. https://www.510kdatabase.net/k240715/ 2024-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k240715-idys-c-zp-3dti-fda-510k.jpg K240715 - Idys® C ZP 3DTi K240715 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Clariance. Cleared Mar 2024. https://www.510kdatabase.net/den230034/ 2024-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/den230034-x100-with-full-field-bone-marrow-fda-510k.jpg DEN230034 - X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with Full Field Bone Marrow Aspirate (BMA) Application DEN230034 is a FDA 510(k) cleared hematology medical device. Manufacturer: Scopio Labs , Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k230088/ 2024-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k230088-ankle-truss-system-ats-fda-510k.jpg K230088 - Ankle Truss System (ATS) K230088 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 4Web Medical, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k232439/ 2024-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k232439-electrical-stimulator-system-fda-510k.jpg K232439 - Electrical Stimulator System K232439 is a FDA 510(k) cleared neurology medical device. Manufacturer: Gymmax Technology Shenzen Co., Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k232568/ 2024-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k232568-ipg-medical-family-of-thulium-fiber-fda-510k.jpg K232568 - IPG Medical Family of Thulium Fiber Lasers, Surgical Fibers, and Accessories K232568 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ipg Medical Corporation. Cleared Mar 2024. https://www.510kdatabase.net/k233665/ 2024-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k233665-depuy-synthes-volt-mini-fragment-fda-510k.jpg K233665 - DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating System K233665 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Synthes. Cleared Mar 2024. https://www.510kdatabase.net/k233753/ 2024-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k233753-ai-rad-companion-pulmonary-fda-510k.jpg K233753 - AI-Rad Companion (Pulmonary) K233753 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Healthcare GmbH. Cleared Mar 2024. https://www.510kdatabase.net/k233926/ 2024-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k233926-accufit-fda-510k.jpg K233926 - accufit K233926 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Mettler Electronics Corporation. Cleared Mar 2024. https://www.510kdatabase.net/k233980/ 2024-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k233980-attune-total-knee-system-attune-fda-510k.jpg K233980 - ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation System, Sigma High Performance (HP) Partial Knee System K233980 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Ireland UC. Cleared Mar 2024. https://www.510kdatabase.net/k234006/ 2024-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k234006-allsource-drug-detector-fentest-fda-510k.jpg K234006 - AllSource Drug Detector FenTest K234006 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Allsource Screening Solutions. Cleared Mar 2024. https://www.510kdatabase.net/k234062/ 2024-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k234062-aptus-hand-scaphoid-plates-fda-510k.jpg K234062 - APTUS Hand Scaphoid Plates K234062 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medartis AG. Cleared Mar 2024. https://www.510kdatabase.net/k234081/ 2024-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k234081-reddrop-one-one-fda-510k.jpg K234081 - RedDrop ONE (One) K234081 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Reddrop DX. Cleared Mar 2024. https://www.510kdatabase.net/k240122/ 2024-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k240122-normatec-elite-fda-510k.jpg K240122 - Normatec Elite K240122 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: NormaTec Industries, LP. Cleared Mar 2024. https://www.510kdatabase.net/k240179/ 2024-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k240179-medical-diode-laser-model-l2-fda-510k.jpg K240179 - Medical Diode Laser (Model: L2) K240179 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wuhan Pioon Technology Co., Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k240253/ 2024-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k240253-reach-needle-fda-510k.jpg K240253 - Reach Needle K240253 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Aerin Medical, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k240309/ 2024-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k240309-tandem-mobi-insulin-pump-with-fda-510k.jpg K240309 - Tandem Mobi insulin pump with interoperable technology K240309 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Tandem Diabetes Care, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k240530/ 2024-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k240530-dynanail-mini-tapered-hybrid-fda-510k.jpg K240530 - DynaNail Mini Tapered Hybrid K240530 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: MedShape, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k240754/ 2024-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k240754-n2-fda-510k.jpg K240754 - N2 K240754 is a FDA 510(k) cleared dental medical device. Manufacturer: Megagen Implant Co., Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k231974/ 2024-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k231974-pathfasths-ctni-ii-fda-510k.jpg K231974 - PATHFAST®hs-cTnI-II K231974 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Phc Corporation. Cleared Mar 2024. https://www.510kdatabase.net/k232125/ 2024-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k232125-v-pvp-fda-510k.jpg K232125 - V-PVP K232125 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Vitromed GmbH. Cleared Mar 2024. https://www.510kdatabase.net/k232654/ 2024-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k232654-nephron-nitrile-nitrile-powder-free-fda-510k.jpg K232654 - Nephron Nitrile™, Nitrile Powder-Free Examination Gloves Black (Tested For Use With Chemotherapy Drugs and Fentanyl) K232654 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Nephron Nitrile, LLC. Cleared Mar 2024. https://www.510kdatabase.net/k233002/ 2024-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k233002-beed-25-beed-38-fda-510k.jpg K233002 - BEED 2,5, BEED 3,8 K233002 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Excelsior Resources, LLC. Cleared Mar 2024. https://www.510kdatabase.net/k233375/ 2024-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k233375-tranquil-l-interbody-system-fda-510k.jpg K233375 - Tranquil-L Interbody System K233375 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nexus Spine, LLC. Cleared Mar 2024. https://www.510kdatabase.net/k233642/ 2024-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k233642-inmode-rf-system-fda-510k.jpg K233642 - InMode RF System K233642 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Inmode , Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k233901/ 2024-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k233901-baby-nasal-aspirator-ka1006-ka1001-fda-510k.jpg K233901 - Baby Nasal Aspirator (KA1006, KA1001, KA1005, NASA005, NASA006, NASA008, NASA009) K233901 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Shenzhen Desida Technology Co., Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k234047/ 2024-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k234047-automatic-registration-fda-510k.jpg K234047 - Automatic Registration K234047 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Brainlab AG. Cleared Mar 2024. https://www.510kdatabase.net/k234049/ 2024-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k234049-straumann-blc-and-tlc-implants-line-fda-510k.jpg K234049 - Straumann® BLC and TLC Implants - Line extension K234049 is a FDA 510(k) cleared dental medical device. Manufacturer: Institut Straumann AG. Cleared Mar 2024. https://www.510kdatabase.net/k234052/ 2024-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k234052-access-ferritin-fda-510k.jpg K234052 - Access Ferritin K234052 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k234090/ 2024-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k234090-explorer-air-ii-8001-8002-8003-fda-510k.jpg K234090 - EXPLORER AIR® II (8001, 8002, 8003) K234090 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Surgvision GmbH. Cleared Mar 2024. https://www.510kdatabase.net/k234130/ 2024-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k234130-portrait-mobile-monitoring-solution-fda-510k.jpg K234130 - Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application (Portrait CVAXB) • Portrait™ Core Services (Portrait CSSXB) • Portrait™ Clinical Alarming Unit (Portrait CAU01) • Portrait™ Mobile Patient Monitor Hardware (Portrait HUBXB) • Portrait™ Mobile Patient Monitor Software (Portrait HSWXB) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) • Portrait™ Wearable Pulse O K234130 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Ge Medical Systems Information Technologies, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k240165/ 2024-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k240165-aneroid-sphygmomanometer-with-fda-510k.jpg K240165 - Aneroid Sphygmomanometer with Stethoscope K240165 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Wenzhou Longwan Medical Device Factory. Cleared Mar 2024. https://www.510kdatabase.net/k240507/ 2024-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k240507-nuvasive-attrax-scaffold-fda-510k.jpg K240507 - NuVasive AttraX Scaffold K240507 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nuvasive, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k240537/ 2024-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k240537-smartxide-pro-fda-510k.jpg K240537 - SMARTXIDE PRO K240537 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: El.En S.P.A.. Cleared Mar 2024. https://www.510kdatabase.net/k240574/ 2024-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k240574-bruxzir-radiant-fda-510k.jpg K240574 - BruxZir® Radiant K240574 is a FDA 510(k) cleared dental medical device. Manufacturer: Prismatik Dentalcraft, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k240743/ 2024-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k240743-peak-universal-bond-fda-510k.jpg K240743 - Peak Universal Bond K240743 is a FDA 510(k) cleared dental medical device. Manufacturer: Ultradent Products, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k231719/ 2024-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k231719-medical-surgical-mask-fda-510k.jpg K231719 - Medical Surgical Mask K231719 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Azur Medical Company, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k231843/ 2024-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k231843-arx-viral-transport-media-collection-fda-510k.jpg K231843 - ARX Viral Transport Media Collection and Transport System K231843 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Arx Sciences, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k232619/ 2024-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k232619-matrix-ha-peek-cervical-ibf-system-fda-510k.jpg K232619 - MATRIX HA PEEK Cervical IBF System K232619 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Sapphire Medical Group. Cleared Mar 2024. https://www.510kdatabase.net/k232682/ 2024-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k232682-pre-sintered-zirconia-coloring-liquid-fda-510k.jpg K232682 - Pre-Sintered Zirconia Coloring Liquid K232682 is a FDA 510(k) cleared dental medical device. Manufacturer: Chengdu Besmile Medical Technology Co., Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k233146/ 2024-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k233146-blood-pressure-monitor-fda-510k.jpg K233146 - Blood Pressure Monitor K233146 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Jamr Technology Co., Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k233772/ 2024-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k233772-disposable-dual-action-tissue-closure-fda-510k.jpg K233772 - Disposable Dual Action Tissue Closure Device K233772 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Mirco-Tech (Nanjing) Co., Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k234024/ 2024-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k234024-hwject-auto-disable-syringe-fda-510k.jpg K234024 - HWJECT Auto-disable syringe K234024 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k240668/ 2024-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k240668-amydi-med-disposable-non-invasive-eeg-fda-510k.jpg K240668 - Amydi-med Disposable Non-invasive EEG electrodes K240668 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Amydi-Med Electrics Tech Co., Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k233599/ 2024-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k233599-x-clever-ashk100g-fda-510k.jpg K233599 - X-Clever (ASHK100G) K233599 is a FDA 510(k) cleared radiology medical device. Manufacturer: Lg Electronics.Inc. Cleared Mar 2024. https://www.510kdatabase.net/k233660/ 2024-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k233660-ncommand-lite-system-fda-510k.jpg K233660 - nCommand Lite System K233660 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ionic Health. Cleared Mar 2024. https://www.510kdatabase.net/k240113/ 2024-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k240113-coriograph-knee-pre-op-plan-fda-510k.jpg K240113 - CORIOGRAPH Knee Pre-Op Plan K240113 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k240139/ 2024-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k240139-real-intelligence-cori-fda-510k.jpg K240139 - Real Intelligence™ CORI™ K240139 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Blue Belt Technologies, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k240515/ 2024-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k240515-union-max-cervical-plate-system-fda-510k.jpg K240515 - uNion® MAX Cervical Plate System K240515 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ulrich Medical USA, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k230981/ 2024-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k230981-meriglu-topical-skin-adhesive-fda-510k.jpg K230981 - Meriglu Topical Skin Adhesive K230981 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: M/s. Meril Endo Surgery Private Limited.. Cleared Mar 2024. https://www.510kdatabase.net/k230802/ 2024-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k230802-xprecia-prime-coagulation-system-fda-510k.jpg K230802 - Xprecia Prime Coagulation System K230802 is a FDA 510(k) cleared hematology medical device. Manufacturer: Universal Biosensors Pty, Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k231856/ 2024-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k231856-topfine-lds-low-dead-space-syringe-2-fda-510k.jpg K231856 - TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, TS-LDS2534)) K231856 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medexel Co.,Ltd. Cleared Mar 2024. https://www.510kdatabase.net/k232234/ 2024-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k232234-nouvo-safety-set-fda-510k.jpg K232234 - Nouvo Safety Set K232234 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Poly Medicure Limited. Cleared Mar 2024. https://www.510kdatabase.net/k232327/ 2024-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k232327-endorail-fda-510k.jpg K232327 - Endorail K232327 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Endostart S.R.L.. Cleared Mar 2024. https://www.510kdatabase.net/k233307/ 2024-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k233307-intensity-pulsed-light-therapy-system-fda-510k.jpg K233307 - Intensity Pulsed Light Therapy System K233307 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Beijing Adss Development Co., Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k233342/ 2024-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k233342-cina-aspects-fda-510k.jpg K233342 - CINA-ASPECTS K233342 is a FDA 510(k) cleared radiology medical device. Manufacturer: Avicenna.Ai. Cleared Mar 2024. https://www.510kdatabase.net/k233747/ 2024-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k233747-concha-sol-hearing-aids-cl-1001-fda-510k.jpg K233747 - Concha Sol Hearing Aids (CL-1001) K233747 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Concha Labs. Cleared Mar 2024. https://www.510kdatabase.net/k233748/ 2024-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k233748-ciartic-move-vb10-fda-510k.jpg K233748 - CIARTIC Move (VB10) K233748 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k233799/ 2024-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k233799-wrist-blood-pressure-monitor-222-fda-510k.jpg K233799 - Wrist Blood Pressure Monitor (222) K233799 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Yuezhongxing Technology Co., Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k233814/ 2024-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k233814-3m-attest-super-rapid-vaporized-fda-510k.jpg K233814 - 3M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD) K233814 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Mar 2024. https://www.510kdatabase.net/k233881/ 2024-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k233881-ivwatch-model-400-fda-510k.jpg K233881 - ivWatch® Model 400 K233881 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ivwatch, LLC. Cleared Mar 2024. https://www.510kdatabase.net/k233986/ 2024-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k233986-bd-phoenix-automated-microbiology-fda-510k.jpg K233986 - BD Phoenix™ Automated Microbiology System - GN Ciprofloxacin (0.0156–4 µg/mL) K233986 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson and Company. Cleared Mar 2024. https://www.510kdatabase.net/k234104/ 2024-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k234104-picoandy-q-switched-ndyag-laser-fda-510k.jpg K234104 - PICOANDY (Q-Switched Nd:YAG Laser) K234104 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wontech Co., Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k234115/ 2024-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k234115-apro-55-catheter-fda-510k.jpg K234115 - APRO 55 Catheter K234115 is a FDA 510(k) cleared neurology medical device. Manufacturer: Alembic, LLC. Cleared Mar 2024. https://www.510kdatabase.net/k240112/ 2024-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k240112-light-cure-composite-fda-510k.jpg K240112 - Light Cure Composite K240112 is a FDA 510(k) cleared dental medical device. Manufacturer: Sincera Technology (Changchun) Co., Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k240117/ 2024-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k240117-aventus-thrombectomy-system-im-2001im-fda-510k.jpg K240117 - Aventus Thrombectomy System (IM-2001/IM-0002) K240117 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inquis Medical. Cleared Mar 2024. https://www.510kdatabase.net/k240430/ 2024-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k240430-otoport-pro-fda-510k.jpg K240430 - Otoport Pro K240430 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Otodynamics, Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k240441/ 2024-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k240441-milagro-interference-screw-fda-510k.jpg K240441 - MILAGRO Interference Screw K240441 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Mitek. Cleared Mar 2024. https://www.510kdatabase.net/k240454/ 2024-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k240454-responder-polysaccharide-hemostat-fda-510k.jpg K240454 - RESPONDER® Polysaccharide Hemostat K240454 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Starch Medical, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k240466/ 2024-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k240466-starband-3d-fda-510k.jpg K240466 - STARband 3D K240466 is a FDA 510(k) cleared neurology medical device. Manufacturer: Orthomerica Products, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k240539/ 2024-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k240539-vital-spinal-fixation-system-fda-510k.jpg K240539 - Vital™ Spinal Fixation System K240539 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimvie Spine (Zimmer Biomet Spine, Inc.). Cleared Mar 2024. https://www.510kdatabase.net/k240694/ 2024-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k240694-forma-composite-shade-a3d-fda-510k.jpg K240694 - FORMA Composite (Shade A3D) K240694 is a FDA 510(k) cleared dental medical device. Manufacturer: Ultradent Products, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k231529/ 2024-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k231529-cloudpoint-fastdesign-chairside-fda-510k.jpg K231529 - CloudPoint FastDesign Chairside K231529 is a FDA 510(k) cleared dental medical device. Manufacturer: Prismatik Dentalcraft, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k231850/ 2024-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k231850-quartex-occipito-cervico-thoracic-fda-510k.jpg K231850 - QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments K231850 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k232301/ 2024-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k232301-define-rf-microneedling-system-fda-510k.jpg K232301 - Define RF Microneedling System K232301 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesthetic Management Partners. Cleared Mar 2024. https://www.510kdatabase.net/k232567/ 2024-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k232567-myriad-spectra-light-source-fda-510k.jpg K232567 - Myriad SPECTRA Light Source K232567 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nico Corporation. Cleared Mar 2024. https://www.510kdatabase.net/k232610/ 2024-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k232610-da-vinci-surgical-system-model-is5000-fda-510k.jpg K232610 - da Vinci Surgical System Model IS5000, da Vinci Insufflator and Tube Set with Smoke Evacuation K232610 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k232803/ 2024-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k232803-nxstage-system-one-with-cartridge-fda-510k.jpg K232803 - NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E) K232803 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Nxstage Medical, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k232980/ 2024-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k232980-spermalign-sperm-separation-device-fda-510k.jpg K232980 - SpermAlign Sperm Separation Device K232980 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Cytoswim, Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k233542/ 2024-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k233542-ortho-guidance-precision-knee-software-fda-510k.jpg K233542 - Ortho Guidance Precision Knee Software K233542 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Leibinger GmbH & Co KG. Cleared Mar 2024. https://www.510kdatabase.net/k233853/ 2024-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k233853-lumiguide-wire-fda-510k.jpg K233853 - LumiGuide Wire K233853 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Mar 2024. https://www.510kdatabase.net/k233958/ 2024-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k233958-hekadrill-fda-510k.jpg K233958 - hekaDrill K233958 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Zethon, Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k232022/ 2024-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k232022-cas-one-ir-fda-510k.jpg K232022 - CAS-One IR K232022 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cascination AG. Cleared Mar 2024. https://www.510kdatabase.net/k233070/ 2024-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k233070-smart-muscle-training-wearables-fda-510k.jpg K233070 - Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N) K233070 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Chongqing Rob Linka Science and Technology Co., Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k233136/ 2024-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k233136-hygeia-express-powered-breast-pump-fda-510k.jpg K233136 - Hygeia Express Powered Breast Pump K233136 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Hygeia II Medical Group, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k233466/ 2024-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k233466-edison-system-fda-510k.jpg K233466 - Edison System K233466 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: HistoSonics, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k233592/ 2024-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k233592-biopoly-radial-head-implant-fda-510k.jpg K233592 - BioPoly Radial Head Implant K233592 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: BioPoly, LLC. Cleared Mar 2024. https://www.510kdatabase.net/k233930/ 2024-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k233930-mrcp-version-2-mrcp-v2-fda-510k.jpg K233930 - MRCP+ version 2 (MRCP+ v2) K233930 is a FDA 510(k) cleared radiology medical device. Manufacturer: Perspectum. Cleared Mar 2024. https://www.510kdatabase.net/k233946/ 2024-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k233946-immulite-2000-br-ma-fda-510k.jpg K233946 - IMMULITE® 2000 BR-MA K233946 is a FDA 510(k) cleared immunology medical device. Manufacturer: Siemens Healthcare Diagnostics Products, Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k233949/ 2024-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k233949-accord-cable-system-fda-510k.jpg K233949 - ACCORD Cable System K233949 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k233952/ 2024-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k233952-deka-ace-pump-system-fda-510k.jpg K233952 - DEKA ACE Pump System K233952 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Deka Research and Development. Cleared Mar 2024. https://www.510kdatabase.net/k233968/ 2024-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k233968-cina-ipe-fda-510k.jpg K233968 - CINA-iPE K233968 is a FDA 510(k) cleared radiology medical device. Manufacturer: Avicenna.Ai. Cleared Mar 2024. https://www.510kdatabase.net/k234002/ 2024-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k234002-icefx-cryoablation-system-fprch8000-02-fda-510k.jpg K234002 - ICEfx Cryoablation System (FPRCH8000-02) K234002 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Boston Scientific. Cleared Mar 2024. https://www.510kdatabase.net/k234008/ 2024-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k234008-cerament-g-fda-510k.jpg K234008 - CERAMENT G K234008 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Bonesupport AB. Cleared Mar 2024. https://www.510kdatabase.net/k234055/ 2024-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k234055-deka-loop-fda-510k.jpg K234055 - DEKA Loop K234055 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Deka Research and Development. Cleared Mar 2024. https://www.510kdatabase.net/k231849/ 2024-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k231849-minicap-extended-life-pd-transfer-set-fda-510k.jpg K231849 - MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A K231849 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare. Cleared Mar 2024. https://www.510kdatabase.net/k232564/ 2024-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k232564-align-studio-fda-510k.jpg K232564 - Align Studio K232564 is a FDA 510(k) cleared dental medical device. Manufacturer: Laon Medi, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k233381/ 2024-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k233381-drx-evolution-plus-system-fda-510k.jpg K233381 - DRX-Evolution Plus System K233381 is a FDA 510(k) cleared radiology medical device. Manufacturer: Carestream Health, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k240132/ 2024-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k240132-emoled-v-2-usa-fda-510k.jpg K240132 - EmoLED (v. 2-USA) K240132 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Emoled, Srl. Cleared Mar 2024. https://www.510kdatabase.net/k240416/ 2024-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k240416-tranquil-c-interbody-system-fda-510k.jpg K240416 - Tranquil-C Interbody System K240416 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nexus Spine, LLC. Cleared Mar 2024. https://www.510kdatabase.net/k240424/ 2024-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k240424-mineral-collagen-composite-bioactive-fda-510k.jpg K240424 - Mineral Collagen Composite Bioactive Moldable Bone Graft Matrix K240424 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Collagen Matrix, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k240497/ 2024-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k240497-smartxide-tetra-pro-fda-510k.jpg K240497 - Smartxide Tetra Pro K240497 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: El.En S.P.A.. Cleared Mar 2024. https://www.510kdatabase.net/k231758/ 2024-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k231758-nxtag-respiratory-pathogen-panel-v2-fda-510k.jpg K231758 - NxTAG Respiratory Pathogen Panel v2 (NxTAG RPP v2) K231758 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Luminex Molecular Diagnostics, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k231789/ 2024-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k231789-pain-therapy-device-model-pts-vi-pts-vii-fda-510k.jpg K231789 - Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII) K231789 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Guangzhou Xinbo Electronic Co., Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k231864/ 2024-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k231864-fiber-optic-brushless-electronic-fda-510k.jpg K231864 - Fiber Optic Brushless Electronic Micromotor, model: iM100 K231864 is a FDA 510(k) cleared dental medical device. Manufacturer: Codent Technical Industry Co., Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k232140/ 2024-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k232140-ots-hip-fda-510k.jpg K232140 - OTS Hip K232140 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ortoma AB. Cleared Mar 2024. https://www.510kdatabase.net/k233724/ 2024-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k233724-28mm38d-mdm-x3-insert-for-mdm-liner-fda-510k.jpg K233724 - 28mm/38D MDM X3 Insert for MDM Liner K233724 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp., Dba Stryker Orthopaedics. Cleared Mar 2024. https://www.510kdatabase.net/k233912/ 2024-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k233912-arix-cannulated-screw-system-fda-510k.jpg K233912 - ARIX Cannulated Screw System K233912 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Jeil Medical Corporation. Cleared Mar 2024. https://www.510kdatabase.net/k233922/ 2024-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k233922-sp-newtron-can-a-fda-510k.jpg K233922 - SP NEWTRON CAN-A K233922 is a FDA 510(k) cleared dental medical device. Manufacturer: Satelec - Acteon Group. Cleared Mar 2024. https://www.510kdatabase.net/k234000/ 2024-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k234000-vitek-2-ast-gram-positive-lefamulin-fda-510k.jpg K234000 - VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) K234000 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k234015/ 2024-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k234015-caphosol-artifical-saliva-32-doses-fda-510k.jpg K234015 - Caphosol® Artifical Saliva (32 doses sachet box) K234015 is a FDA 510(k) cleared dental medical device. Manufacturer: Eusa Pharma (Uk) Limited. Cleared Mar 2024. https://www.510kdatabase.net/k233083/ 2024-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k233083-osteon-precision-milled-suprastructure-fda-510k.jpg K233083 - Osteon Precision Milled Suprastructure K233083 is a FDA 510(k) cleared dental medical device. Manufacturer: Implant Solutions Pty Ltd (Aka Osteon Medical). Cleared Mar 2024. https://www.510kdatabase.net/k230195/ 2024-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k230195-neo-advise-software-fda-510k.jpg K230195 - Neo ADVISE software K230195 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Comerge AG. Cleared Mar 2024. https://www.510kdatabase.net/k231056/ 2024-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k231056-esperance-distal-access-catheter-fda-510k.jpg K231056 - Esperance Distal Access Catheter K231056 is a FDA 510(k) cleared neurology medical device. Manufacturer: Wallaby Medical. Cleared Mar 2024. https://www.510kdatabase.net/k231734/ 2024-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k231734-steriject-low-dead-space-steriject-the-fda-510k.jpg K231734 - STERiJECT Low Dead Space, STERiJECT The Invisible Needle K231734 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Tsk Laboratory International Japan KK. Cleared Mar 2024. https://www.510kdatabase.net/k231760/ 2024-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k231760-hp-oct-hp-oct-fda-510k.jpg K231760 - HP-OCT (HP-OCT) K231760 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Cylite Pty. , Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k231813/ 2024-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k231813-ultrasonic-gastrovideoscope-fda-510k.jpg K231813 - Ultrasonic Gastrovideoscope K231813 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Sonoscape Medical Corp.. Cleared Mar 2024. https://www.510kdatabase.net/k231904/ 2024-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k231904-rapid-fentanyl-fyl-test-strip-rapid-fda-510k.jpg K231904 - Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test Dipcard K231904 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Co-Innovation Biotech Co., Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k232826/ 2024-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k232826-articulator-injection-needle-00711807-fda-510k.jpg K232826 - Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Needle (00711812), Carr-Locke Injection Needle (00711813), Carr-Locke Injection Needle (00711814), Carr-Locke Injection Needle (00711822), Carr-Locke Injection Needle (00711823), Carr-Locke Injection Needle (00711824) K232826 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Steris. Cleared Mar 2024. https://www.510kdatabase.net/k233038/ 2024-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k233038-vital-signs-monitor-model-im3s-im3as-fda-510k.jpg K233038 - Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s K233038 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edan Instruments, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k233177/ 2024-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k233177-nest-vt-vitrification-device-fda-510k.jpg K233177 - Nest VT Vitrification Device K233177 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Cook Incorporated. Cleared Mar 2024. https://www.510kdatabase.net/k233198/ 2024-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k233198-ossiofiber-threaded-trimmable-fixation-fda-510k.jpg K233198 - OSSIOfiber® Threaded Trimmable Fixation Nails K233198 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OSSIO , Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k233359/ 2024-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k233359-dominion-expandable-corpectomy-system-fda-510k.jpg K233359 - DOMINION Expandable Corpectomy System K233359 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Astura Medical. Cleared Mar 2024. https://www.510kdatabase.net/k233421/ 2024-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k233421-rescan-700-fda-510k.jpg K233421 - RESCAN 700 K233421 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Carl Zeiss Meditec, AG. Cleared Mar 2024. https://www.510kdatabase.net/k233438/ 2024-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k233438-sleepstageml-fda-510k.jpg K233438 - SleepStageML K233438 is a FDA 510(k) cleared neurology medical device. Manufacturer: Beacon Biosignals, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k233649/ 2024-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k233649-algo-pro-newborn-hearing-screener-algo-fda-510k.jpg K233649 - ALGO Pro Newborn Hearing Screener (ALGO Pro) K233649 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). Cleared Mar 2024. https://www.510kdatabase.net/k233705/ 2024-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k233705-cellfx-percutaneous-electrode-system-fda-510k.jpg K233705 - CellFX Percutaneous Electrode System (SYS3000) K233705 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Pulse Biosciences, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k233758/ 2024-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k233758-trivicta-hip-stem-fda-510k.jpg K233758 - Trivicta™ Hip Stem K233758 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ortho Development Corp.. Cleared Mar 2024. https://www.510kdatabase.net/k233899/ 2024-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k233899-knee-fda-510k.jpg K233899 - Knee+ K233899 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Pixee Medical. Cleared Mar 2024. https://www.510kdatabase.net/k233943/ 2024-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k233943-affera-mapping-system-afr-00003-fda-510k.jpg K233943 - Affera Mapping System (AFR-00003) K233943 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k234046/ 2024-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k234046-wallflex-colonic-stent-system-with-fda-510k.jpg K234046 - WallFlex Colonic Stent System with Anchor Lock Delivery System K234046 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Mar 2024. https://www.510kdatabase.net/k240264/ 2024-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k240264-home-use-hair-removal-device-fda-510k.jpg K240264 - Home Use Hair Removal Device (Model(s):T10A, T10B, T10C, T10D, T11A, T15A, T17A, T18A, T14A, T16A, T19A) K240264 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Mlay Intelligent Technology Co., Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k240384/ 2024-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k240384-sendero-microcatheter-fda-510k.jpg K240384 - SENDERO Microcatheter K240384 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Okami Medical, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k240396/ 2024-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k240396-elite-iq-pro-m122k1-fda-510k.jpg K240396 - Elite iQ PRO (M122K1) K240396 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cynosure, LLC. Cleared Mar 2024. https://www.510kdatabase.net/k232207/ 2024-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k232207-dkutting-pta-scoring-balloon-fda-510k.jpg K232207 - D·Kutting™ PTA Scoring Balloon Dilatation Catheter K232207 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Dk Medical Technology Co., Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k232781/ 2024-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k232781-safety-sliding-blood-collection-set-fda-510k.jpg K232781 - Safety Sliding Blood Collection Set K232781 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Caina Medical Co.,Ltd. Cleared Mar 2024. https://www.510kdatabase.net/k233692/ 2024-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k233692-voluson-signature-20-voluson-signature-fda-510k.jpg K233692 - Voluson Signature 20, Voluson Signature 18 K233692 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared Mar 2024. https://www.510kdatabase.net/k240371/ 2024-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k240371-0909fcc-0909fcc-hs-fda-510k.jpg K240371 - 0909FCC, 0909FCC-HS K240371 is a FDA 510(k) cleared radiology medical device. Manufacturer: Rayence Co., Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k240407/ 2024-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k240407-iconix-all-suture-anchor-fda-510k.jpg K240407 - ICONIX All-Suture Anchor K240407 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Endoscopy. Cleared Mar 2024. https://www.510kdatabase.net/k240458/ 2024-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k240458-synthetic-bone-putty-fda-510k.jpg K240458 - Synthetic Bone Putty K240458 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ventris Medical. Cleared Mar 2024. https://www.510kdatabase.net/k231403/ 2024-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k231403-evodrill-cranial-perforator-fda-510k.jpg K231403 - evoDrill Cranial Perforator K231403 is a FDA 510(k) cleared neurology medical device. Manufacturer: Evonos GmbH & Co. KG. Cleared Mar 2024. https://www.510kdatabase.net/k231497/ 2024-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k231497-choledochoscope-system-fda-510k.jpg K231497 - Choledochoscope System K231497 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Shenzhen HugeMed Medical Technical Development Co., Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k231677/ 2024-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k231677-edgeflow-uh10-fda-510k.jpg K231677 - EdgeFlow UH10 K231677 is a FDA 510(k) cleared radiology medical device. Manufacturer: Edgecare, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k231786/ 2024-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k231786-gynethotics-pessary-fda-510k.jpg K231786 - Gynethotics™ Pessary K231786 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Cosm Medical. Cleared Mar 2024. https://www.510kdatabase.net/k232004/ 2024-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k232004-defendo-pentax-single-use-biopsy-valve-fda-510k.jpg K232004 - Defendo Pentax Single Use Biopsy Valve, Defendo Pentax Single Use Air/Water Valve, Defendo Pentax Single Use Suction Valve, Endogator Pentax Single Use Connector K232004 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medivators (A Subsidiary of Steris Corporation). Cleared Mar 2024. https://www.510kdatabase.net/k232270/ 2024-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k232270-dvt-motion-pneumatic-compression-device-fda-510k.jpg K232270 - DVT Motion Pneumatic Compression Device K232270 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Koge Micro Tech Co., Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k232424/ 2024-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k232424-currentbody-skin-rf-fda-510k.jpg K232424 - CurrentBody Skin RF K232424 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: El Global Trade, Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k232703/ 2024-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k232703-disposable-bipolar-forceps-fda-510k.jpg K232703 - Disposable Bipolar Forceps K232703 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Jiangsu Hope Biomedical Science & Technology Co., Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k233021/ 2024-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k233021-bd-smartsite-13mm-vial-access-device-fda-510k.jpg K233021 - BD SmartSite™ 13mm Vial Access Device K233021 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Care Fusion. Cleared Mar 2024. https://www.510kdatabase.net/k233075/ 2024-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k233075-biogend-interbody-fusion-system-001-cage-fda-510k.jpg K233075 - “BioGend” Interbody Fusion System 001 Cage K233075 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biogend Therapeutics Co., Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k233572/ 2024-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k233572-autofuse-fda-510k.jpg K233572 - Autofuse K233572 is a FDA 510(k) cleared radiology medical device. Manufacturer: Pymedix. Cleared Mar 2024. https://www.510kdatabase.net/k233794/ 2024-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k233794-insulin-syringe-fda-510k.jpg K233794 - Insulin Syringe K233794 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Spm Medicare Pvt. , Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k233880/ 2024-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k233880-momcozy-wearable-breast-pump-bp137-fda-510k.jpg K233880 - Momcozy Wearable Breast Pump (BP137) K233880 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shenzhen Root Innovation Technology Co., Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k240273/ 2024-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k240273-access-free-t4-fda-510k.jpg K240273 - Access Free T4 K240273 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k240351/ 2024-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k240351-fastep-fentanyl-rapid-test-device-urine-fda-510k.jpg K240351 - FaStep Fentanyl Rapid Test Device (Urine) K240351 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Assure Tech., LLC. Cleared Mar 2024. https://www.510kdatabase.net/k240352/ 2024-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k240352-defendo-single-use-cleaning-adapter-fda-510k.jpg K240352 - Defendo Single Use Cleaning Adapter for Olympus Endoscopes K240352 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: STERIS Corporation. Cleared Mar 2024. https://www.510kdatabase.net/k240619/ 2024-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k240619-e-sdf-fda-510k.jpg K240619 - e-SDF K240619 is a FDA 510(k) cleared dental medical device. Manufacturer: Kids-E-Dental Llp. Cleared Mar 2024. https://www.510kdatabase.net/k231210/ 2024-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k231210-dga-abutment-fda-510k.jpg K231210 - DGA Abutment K231210 is a FDA 510(k) cleared dental medical device. Manufacturer: Modern Dental Laboratory (Dg) Co., Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k231260/ 2024-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k231260-htx-disposable-hysteroscope-system-fda-510k.jpg K231260 - HTx Disposable Hysteroscope System K231260 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Suzhou AcuVu Medical Technology Co., Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k233526/ 2024-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k233526-medline-open-back-level-3-protective-fda-510k.jpg K233526 - Medline Open-back Level 3 Protective Gown K233526 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, LP. Cleared Mar 2024. https://www.510kdatabase.net/k233859/ 2024-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k233859-basis-flow-ii-fda-510k.jpg K233859 - BASIS FLOW II K233859 is a FDA 510(k) cleared dental medical device. Manufacturer: YAMAHACHI DENTAL MFG., Co.. Cleared Mar 2024. https://www.510kdatabase.net/k234070/ 2024-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k234070-stelo-glucose-biosensor-system-fda-510k.jpg K234070 - Stelo Glucose Biosensor System K234070 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dexcom, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k240090/ 2024-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k240090-argo-knotless-genesys-anchor-fda-510k.jpg K240090 - Argo Knotless GENESYS Anchor K240090 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Conmed Corporation. Cleared Mar 2024. https://www.510kdatabase.net/k240404/ 2024-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k240404-novabone-putty-bioactive-synthetic-fda-510k.jpg K240404 - NovaBone Putty - Bioactive Synthetic Bone Graft (NB6600, NB6610, NB6615) K240404 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Novabone Products, LLC. Cleared Mar 2024. https://www.510kdatabase.net/k240459/ 2024-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k240459-cerament-bone-void-filler-fda-510k.jpg K240459 - Cerament Bone Void Filler K240459 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Bonesupport AB. Cleared Mar 2024. https://www.510kdatabase.net/k240597/ 2024-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k240597-tera-harz-clear-fda-510k.jpg K240597 - TERA HARZ CLEAR K240597 is a FDA 510(k) cleared dental medical device. Manufacturer: Graphy, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k230047/ 2024-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k230047-medical-diode-laser-systems-fda-510k.jpg K230047 - Medical Diode Laser Systems K230047 is a FDA 510(k) cleared dental medical device. Manufacturer: Gigaalaser Company , Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k231288/ 2024-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k231288-vyvo-fda-510k.jpg K231288 - Vyvo K231288 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Vyvo Technology Corp.(Vt). Cleared Mar 2024. https://www.510kdatabase.net/k233738/ 2024-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k233738-overjet-caries-assist-pediatric-fda-510k.jpg K233738 - Overjet Caries Assist-Pediatric K233738 is a FDA 510(k) cleared radiology medical device. Manufacturer: Overjet, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k233877/ 2024-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k233877-xt-series-power-wheelchair-xt2-xt-fda-510k.jpg K233877 - XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4) K233877 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Magic Mobility. Cleared Mar 2024. https://www.510kdatabase.net/k240453/ 2024-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k240453-rebossis-fda-510k.jpg K240453 - ReBOSSIS K240453 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthorebirth Co., Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k231365/ 2024-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k231365-nitrile-patient-examination-gloves-fda-510k.jpg K231365 - Nitrile Patient Examination Gloves with Hyaluronic Acid Blue Colored and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, aka Synguard C+ Nitrile Exam Gloves K231365 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Anhui Intco Medical Products Co., Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k231648/ 2024-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k231648-muscle-stimulator-fda-510k.jpg K231648 - Muscle Stimulator K231648 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Yiran Intelligent Co., Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k231690/ 2024-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k231690-icas-lv-fda-510k.jpg K231690 - iCAS-LV K231690 is a FDA 510(k) cleared radiology medical device. Manufacturer: Highrad , Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k231778/ 2024-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k231778-nihon-kohden-nkv-550-series-ventilator-fda-510k.jpg K231778 - Nihon Kohden NKV-550 Series Ventilator System K231778 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Nihon Kohden Orangemed, LLC. Cleared Mar 2024. https://www.510kdatabase.net/k231915/ 2024-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k231915-zfx-abutments-fda-510k.jpg K231915 - Zfx Abutments K231915 is a FDA 510(k) cleared dental medical device. Manufacturer: Zfx GmbH - A Company of Zimvie. Cleared Mar 2024. https://www.510kdatabase.net/k232040/ 2024-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k232040-gynatrof-fda-510k.jpg K232040 - Gynatrof K232040 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Tyros Biopharma, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k232316/ 2024-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k232316-deka-infusion-system-deka-fda-510k.jpg K232316 - DEKA Infusion System, DEKA Administration Set K232316 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Deka Research and Development. Cleared Mar 2024. https://www.510kdatabase.net/k232328/ 2024-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k232328-insignis-syringe-infusion-system-fda-510k.jpg K232328 - Insignis™ Syringe Infusion System K232328 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Innovative Health Sciences, LLC. Cleared Mar 2024. https://www.510kdatabase.net/k232385/ 2024-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k232385-oxiplexts200-fda-510k.jpg K232385 - OxiplexTS200 K232385 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Iss Medical, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k232791/ 2024-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k232791-access-intact-pth-fda-510k.jpg K232791 - Access Intact PTH K232791 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k232828/ 2024-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k232828-imagenet6-ophthalmic-data-system-fda-510k.jpg K232828 - IMAGEnet6 Ophthalmic Data System K232828 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Topcon Corporation. Cleared Mar 2024. https://www.510kdatabase.net/k233030/ 2024-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k233030-bonemri-fda-510k.jpg K233030 - BoneMRI K233030 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mriguidance B.V.. Cleared Mar 2024. https://www.510kdatabase.net/k233095/ 2024-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k233095-s21-otc-transcutaneous-electrical-fda-510k.jpg K233095 - S21 OTC Transcutaneous Electrical Nerve Stimulator K233095 is a FDA 510(k) cleared neurology medical device. Manufacturer: Micro Current Technology, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k233410/ 2024-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k233410-liaison-plex-respiratory-flex-assay-fda-510k.jpg K233410 - LIAISON PLEX Respiratory Flex Assay K233410 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Luminex Corporation. Cleared Mar 2024. https://www.510kdatabase.net/k233862/ 2024-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k233862-nuna-lux-nunl528-fda-510k.jpg K233862 - NUNA LUX (NUNL528) K233862 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Premier North America, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k240023/ 2024-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k240023-probe-covers-yf-001-yf-002-fda-510k.jpg K240023 - Probe Covers (YF-001, YF-002) K240023 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen YI Fang Blister Packaging Co., Ltd.. Cleared Mar 2024. https://www.510kdatabase.net/k240083/ 2024-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k240083-gore-propaten-vascular-graft-fda-510k.jpg K240083 - GORE® PROPATEN® Vascular Graft K240083 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k240277/ 2024-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k240277-mirodry-wound-matrix-fda-510k.jpg K240277 - MiroDry Wound Matrix K240277 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Reprise Biomedical, Inc.. Cleared Mar 2024. https://www.510kdatabase.net/k230837/ 2024-02-29 monthly 0.5 https://www.510kdatabase.net/og-image/k230837-plazmagik-fda-510k.jpg K230837 - PlazMagik K230837 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Agnes Medical Co., Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k231683/ 2024-02-29 monthly 0.5 https://www.510kdatabase.net/og-image/k231683-inheart-models-fda-510k.jpg K231683 - inHEART Models K231683 is a FDA 510(k) cleared radiology medical device. Manufacturer: Inheart, Sas. Cleared Feb 2024. https://www.510kdatabase.net/k232765/ 2024-02-29 monthly 0.5 https://www.510kdatabase.net/og-image/k232765-magnetom-cimax-fit-fda-510k.jpg K232765 - MAGNETOM Cima.X Fit K232765 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k232842/ 2024-02-29 monthly 0.5 https://www.510kdatabase.net/og-image/k232842-balloon-inflation-system-fda-510k.jpg K232842 - Balloon Inflation System K232842 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ningbo Hicren Biotechnology Co., Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k232971/ 2024-02-29 monthly 0.5 https://www.510kdatabase.net/og-image/k232971-apro-55-catheter-and-alembic-fda-510k.jpg K232971 - APRO 55 Catheter and Alembic Aspiration Tubing K232971 is a FDA 510(k) cleared neurology medical device. Manufacturer: Alembic, LLC. Cleared Feb 2024. https://www.510kdatabase.net/k233360/ 2024-02-29 monthly 0.5 https://www.510kdatabase.net/og-image/k233360-curiteva-thoracolumbar-plate-system-fda-510k.jpg K233360 - Curiteva Thoracolumbar Plate System K233360 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Curiteva, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k240051/ 2024-02-29 monthly 0.5 https://www.510kdatabase.net/og-image/k240051-powder-free-nitrile-examination-gloves-fda-510k.jpg K240051 - Powder Free Nitrile Examination Gloves (Blue), Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs K240051 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Lingshi Hongruida Health Protection Technology Co., Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k240244/ 2024-02-29 monthly 0.5 https://www.510kdatabase.net/og-image/k240244-npseal-small-medium-large-fda-510k.jpg K240244 - NPseal (Small, Medium, Large) K240244 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Guard Medical, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k240257/ 2024-02-29 monthly 0.5 https://www.510kdatabase.net/og-image/k240257-denali-vena-cava-filter-system-femoral-fda-510k.jpg K240257 - Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit K240257 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bd. Cleared Feb 2024. https://www.510kdatabase.net/k240268/ 2024-02-29 monthly 0.5 https://www.510kdatabase.net/og-image/k240268-accu-joint-hemi-implant-fda-510k.jpg K240268 - Accu-Joint Hemi Implant K240268 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Accufix Surgical, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k231845/ 2024-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k231845-dental-unit-model-mare-fda-510k.jpg K231845 - Dental unit Model: Mare K231845 is a FDA 510(k) cleared dental medical device. Manufacturer: Foshan Safety Medical Equipment Co., Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k232562/ 2024-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k232562-powerwire-radiofrequency-guidewire-kit-fda-510k.jpg K232562 - PowerWire Radiofrequency Guidewire Kit K232562 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baylis Medical Technologies, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k232613/ 2024-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k232613-ct-cardiomegaly-fda-510k.jpg K232613 - CT Cardiomegaly K232613 is a FDA 510(k) cleared radiology medical device. Manufacturer: Innolitics, LLC. Cleared Feb 2024. https://www.510kdatabase.net/k232885/ 2024-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k232885-dawn-diode-laser-system-fda-510k.jpg K232885 - Dawn Diode Laser System K232885 is a FDA 510(k) cleared dental medical device. Manufacturer: Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd. Cleared Feb 2024. https://www.510kdatabase.net/k233488/ 2024-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k233488-intraox-20-handheld-tissue-oximeter-fda-510k.jpg K233488 - Intra.Ox™ 2.0 Handheld Tissue Oximeter K233488 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Vioptix, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k233830/ 2024-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k233830-osteocool-20-rf-ablation-system-fda-510k.jpg K233830 - OsteoCool™ 2.0 RF Ablation System K233830 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/den230024/ 2024-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/den230024-technozym-adamts13-activity-fda-510k.jpg DEN230024 - Technozym ADAMTS13 Activity DEN230024 is a FDA 510(k) cleared hematology medical device. Manufacturer: Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM. Cleared Feb 2024. https://www.510kdatabase.net/k222400/ 2024-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k222400-coresculpt-magsculpt-fda-510k.jpg K222400 - Coresculpt & Magsculpt K222400 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: K1Med Co., Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k232522/ 2024-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k232522-ark-levetiracetam-ii-assay-fda-510k.jpg K232522 - ARK Levetiracetam II Assay K232522 is a FDA 510(k) cleared toxicology medical device. Manufacturer: ARK Diagnostics, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k232607/ 2024-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k232607-4cis-sara-spine-system-4cis-vertu-fda-510k.jpg K232607 - 4CIS SARA SPINE SYSTEM, 4CIS VERTU SPINE SYSTEM, 4CIS WILL PEDICLE SCREW SYSTEM, aBle SPINAL FIXATION SYSTEM, aBle Xt SPINAL FIXATION SYSTEM K232607 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Solco Biomedical Copany India Private Limited. Cleared Feb 2024. https://www.510kdatabase.net/k233435/ 2024-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k233435-peace-n-quiet-070-fda-510k.jpg K233435 - Peace N Quiet (0.7.0) K233435 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Pnq Health. Cleared Feb 2024. https://www.510kdatabase.net/k233623/ 2024-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k233623-praxiject-sp-09-nacl-fda-510k.jpg K233623 - Praxiject™ SP 0.9% NaCl K233623 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medxl, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k233879/ 2024-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k233879-vasoview-hemopro-3-endoscopic-vessel-fda-510k.jpg K233879 - Vasoview Hemopro 3 Endoscopic Vessel Harvesting System (VH-6000), Vasoview Hemopro 3 Endoscopic Vessel Harvesting System with Vasoshield (VH-6001), Vasoview Hemopro 3 Power Adapter (VH-6020) K233879 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Maquet Cardiovascular, LLC. Cleared Feb 2024. https://www.510kdatabase.net/k233972/ 2024-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k233972-camber-sacroiliac-si-fixation-system-fda-510k.jpg K233972 - Camber Sacroiliac (SI) Fixation System K233972 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Camber Spine Technologies. Cleared Feb 2024. https://www.510kdatabase.net/k234014/ 2024-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k234014-obsidian-now-fda-510k.jpg K234014 - Obsidian® NOW K234014 is a FDA 510(k) cleared dental medical device. Manufacturer: Prismatik Dentalcraft, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k230693/ 2024-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k230693-bis-advance-monitoring-system-fda-510k.jpg K230693 - BIS™ Advance Monitoring System K230693 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Covidien, LLC. Cleared Feb 2024. https://www.510kdatabase.net/k230782/ 2024-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k230782-tens-device-headaterm-2-model-yf-ht2-fda-510k.jpg K230782 - TENS device-HeadaTerm 2 (Model: YF-HT2) K230782 is a FDA 510(k) cleared neurology medical device. Manufacturer: Wat Medical Technology, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k231822/ 2024-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k231822-golff-sterile-anti-fog-solution-fda-510k.jpg K231822 - GOLFF Sterile Anti-Fog Solution K231822 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Batrik Medical Manufacturing, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k232084/ 2024-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k232084-stellaris-elite-vision-enhancement-fda-510k.jpg K232084 - Stellaris Elite vision enhancement system K232084 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Bausch and Lomb. Cleared Feb 2024. https://www.510kdatabase.net/k232628/ 2024-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k232628-vader-pedicle-system-fda-510k.jpg K232628 - VADER® Pedicle System K232628 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Icotec AG. Cleared Feb 2024. https://www.510kdatabase.net/k232752/ 2024-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k232752-stone-extraction-balloon-vdk-bal-23-fda-510k.jpg K232752 - Stone Extraction Balloon (VDK-BAL-23-11/13/15-B,VDK-BAL-23-15/18/20-B,VDK-BAL-23-9/12/15-B,VDK-BAL-23-10/13/16-B,VDK-BAL-23-8.5/11.5/15-B,VDK-BAL-23-12/15/18-B,VDK-BAL-23-11/13/15-C,VDK-BAL-23-15/18/20-C,VDK-BAL-23-9/12/15-C,VDK-BAL-23-10/13/16-C,VDK-BAL-23-8.5/11.5/15-C,VDK-BAL-23-12/15/18-C) K232752 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Jiangsu Vedkang Medical Science and Technology Co., Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k233560/ 2024-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k233560-powder-free-nitrile-examination-glove-fda-510k.jpg K233560 - Powder Free Nitrile Examination Glove Blue with Low Dermatitis Potential Claim, Tested for use with Chemotherapy Drugs, Fentanyl and Gastric Acid K233560 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Eco Medi Glove Sdn. Bhd.. Cleared Feb 2024. https://www.510kdatabase.net/k233675/ 2024-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k233675-fms-vue-fluid-management-and-tissue-fda-510k.jpg K233675 - FMS VUE™ Fluid Management and Tissue Debridement System K233675 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Mitek, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k234133/ 2024-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k234133-dexcom-g7-continuous-glucose-fda-510k.jpg K234133 - Dexcom G7 Continuous Glucose Monitoring System K234133 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Dexcom, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k230423/ 2024-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k230423-electronic-peak-flow-meter-fda-510k.jpg K230423 - Electronic Peak Flow Meter K230423 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Taian Dalu Medical Instrument Co., Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k231601/ 2024-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k231601-flc-kappa-flc-lambdaflc-control-level-fda-510k.jpg K231601 - FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2 K231601 is a FDA 510(k) cleared immunology medical device. Manufacturer: Sebia. Cleared Feb 2024. https://www.510kdatabase.net/k231679/ 2024-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k231679-contour-plus-blue-blood-glucose-fda-510k.jpg K231679 - CONTOUR® PLUS BLUE Blood Glucose Monitoring System K231679 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Ascensia Diabetes Care. Cleared Feb 2024. https://www.510kdatabase.net/k232075/ 2024-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k232075-statstrip-glucose-hospital-meter-system-fda-510k.jpg K232075 - StatStrip Glucose Hospital Meter System K232075 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Nova Biomedical Corporation. Cleared Feb 2024. https://www.510kdatabase.net/k232174/ 2024-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k232174-rainbowtm-multi-layer-block-bright-3-fda-510k.jpg K232174 - rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono K232174 is a FDA 510(k) cleared dental medical device. Manufacturer: Genoss Co., Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k232228/ 2024-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k232228-multi-drug-urine-test-cup-multi-drug-fda-510k.jpg K232228 - Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine Test Cup, Accurature Multi-drug Urine Test Dip Card K232228 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Shanghai Accurature Diagnostics Co., Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k232536/ 2024-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k232536-soldier-microcatheter-fda-510k.jpg K232536 - Soldier Microcatheter K232536 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Embolx, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k232800/ 2024-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k232800-navigation-tracking-instruments-fda-510k.jpg K232800 - Navigation Tracking Instruments K232800 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SI-BONE, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k233576/ 2024-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k233576-konmed-incontinence-stimulation-fda-510k.jpg K233576 - Konmed Incontinence Stimulation Electrode (Vaginal Probe: KM-503, KM-504, KM-505, KM-506, KM-507, KM-5013 K233576 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Shenzhen Konmed Technology Co., Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k233590/ 2024-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k233590-overjet-charting-assist-fda-510k.jpg K233590 - Overjet Charting Assist K233590 is a FDA 510(k) cleared radiology medical device. Manufacturer: Overjet, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k233709/ 2024-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k233709-exceed-unlimited-fda-510k.jpg K233709 - Exceed Unlimited K233709 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Mt. Derm GmbH. Cleared Feb 2024. https://www.510kdatabase.net/k233722/ 2024-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k233722-radspeed-pro-fda-510k.jpg K233722 - RADspeed Pro K233722 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shimadzu Corporation. Cleared Feb 2024. https://www.510kdatabase.net/k233754/ 2024-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k233754-aio-breathe-fda-510k.jpg K233754 - AIO Breathe K233754 is a FDA 510(k) cleared dental medical device. Manufacturer: Aiomega, LLC. Cleared Feb 2024. https://www.510kdatabase.net/k233784/ 2024-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k233784-enso-model-2-fda-510k.jpg K233784 - ENSO (Model 2) K233784 is a FDA 510(k) cleared neurology medical device. Manufacturer: Hinge Health, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k233995/ 2024-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k233995-ivotion-base-print-fda-510k.jpg K233995 - Ivotion Base Print K233995 is a FDA 510(k) cleared dental medical device. Manufacturer: Ivoclar Vivadent, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k240011/ 2024-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k240011-lymphedema-compression-fda-510k.jpg K240011 - Lymphedema Compression K240011 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Jkh Health Co., Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k240190/ 2024-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k240190-myotherm-xp-cardioplegia-delivery-fda-510k.jpg K240190 - MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated K240190 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic. Cleared Feb 2024. https://www.510kdatabase.net/k240201/ 2024-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k240201-pathloc-si-joint-fusion-system-fda-510k.jpg K240201 - PathLoc SI Joint Fusion System K240201 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: L & K Biomed Co., Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k240212/ 2024-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k240212-cognition-staple-system-fda-510k.jpg K240212 - COGNiTiON™ Staple System K240212 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ortho Solutions UK , Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k240213/ 2024-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k240213-iconix-knotless-anchor-fda-510k.jpg K240213 - Iconix Knotless Anchor K240213 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Riverpoint Medical. Cleared Feb 2024. https://www.510kdatabase.net/den230025/ 2024-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/den230025-mira-surgical-system-fda-510k.jpg DEN230025 - MIRA Surgical System DEN230025 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Virtual Incision. Cleared Feb 2024. https://www.510kdatabase.net/k214037/ 2024-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k214037-ergo-flex-technologies-back-on-trac-fda-510k.jpg K214037 - Ergo-Flex Technologies Back on Trac (BOTGEN1) and Cervi-Trac K214037 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Ergo-Flex Technologies, LLC. Cleared Feb 2024. https://www.510kdatabase.net/k223826/ 2024-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k223826-nanodrop-lancet-fda-510k.jpg K223826 - NanoDrop Lancet K223826 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Drawbridge Health, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k231875/ 2024-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k231875-vaginal-tactile-ultrasound-imager-fda-510k.jpg K231875 - Vaginal Tactile Ultrasound Imager K231875 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Advanced Tactile Imaging, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k231876/ 2024-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k231876-multipulse-hoplus-fda-510k.jpg K231876 - MultiPulse HoPLUS K231876 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Asclepion Laser Technologies GmbH. Cleared Feb 2024. https://www.510kdatabase.net/k232074/ 2024-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k232074-serafin-fda-510k.jpg K232074 - Serafin® K232074 is a FDA 510(k) cleared dental medical device. Manufacturer: Tns Co., Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k232163/ 2024-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k232163-lotus-single-lumen-ovum-aspiration-fda-510k.jpg K232163 - Lotus Single Lumen Ovum Aspiration Needle K232163 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Zhejiang Horizon Medical Technology Co., Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k232831/ 2024-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k232831-quiver-aspiration-pump-fda-510k.jpg K232831 - Quiver Aspiration Pump K232831 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Anoxia Medical, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k233544/ 2024-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k233544-mesheet-fda-510k.jpg K233544 - MESHEET K233544 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentis Co., Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k233640/ 2024-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k233640-segmental-plating-system-sps-fda-510k.jpg K233640 - Segmental Plating System (SPS) K233640 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k233749/ 2024-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k233749-revolution-ascend-sliding-fda-510k.jpg K233749 - Revolution Ascend Sliding K233749 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Hangwei Medical Systems Co., Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k233775/ 2024-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k233775-vivatmo-pro-fda-510k.jpg K233775 - Vivatmo pro K233775 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bosch Healthcare Solutions GmbH. Cleared Feb 2024. https://www.510kdatabase.net/k233996/ 2024-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k233996-ulthera-system-uc-1-control-unit-prime-fda-510k.jpg K233996 - Ulthera System (UC-1 Control Unit PRIME) K233996 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ulthera, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k240173/ 2024-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k240173-treace-medical-systems-tmc-plating-fda-510k.jpg K240173 - Treace Medical Systems (TMC) Plating System K240173 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Treace Medical Concepts, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k240174/ 2024-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k240174-1688-4k-camera-system-with-advanced-fda-510k.jpg K240174 - 1688 4K Camera System with Advanced Imaging Modality K240174 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker Endoscopy. Cleared Feb 2024. https://www.510kdatabase.net/k240193/ 2024-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k240193-r501-r502-aortic-root-cannulae-with-fda-510k.jpg K240193 - R501 - R502 aortic root cannulae with and without vent line (R501-15: R501-20: R501-26. R502-15 K240193 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sorin Group Italia S.R.L.. Cleared Feb 2024. https://www.510kdatabase.net/k240313/ 2024-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k240313-oligio-x-fda-510k.jpg K240313 - Oligio X K240313 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wontech Co., Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k231561/ 2024-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k231561-pulmonary-function-tester-model-a9-fda-510k.jpg K231561 - Pulmonary Function Tester, Model: A9 K231561 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Guangzhou Homesun Medical Technology Co., Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k231753/ 2024-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k231753-oneday-implant-abutment-fda-510k.jpg K231753 - Oneday Implant Abutment K231753 is a FDA 510(k) cleared dental medical device. Manufacturer: Oneday Biotech Co., Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k232148/ 2024-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k232148-x-guide-surgical-navigation-system-fda-510k.jpg K232148 - X-Guide Surgical Navigation System K232148 is a FDA 510(k) cleared dental medical device. Manufacturer: X-Nav Technologies, LLC. Cleared Feb 2024. https://www.510kdatabase.net/k232265/ 2024-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k232265-blueprint-patient-specific-fda-510k.jpg K232265 - BLUEPRINT™ Patient Specific Instrumentation K232265 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tornier S.A.S.. Cleared Feb 2024. https://www.510kdatabase.net/k232502/ 2024-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k232502-cocoon-convective-warming-system-model-fda-510k.jpg K232502 - Cocoon Convective Warming System, Model CWS7000 K232502 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Care Essentials Pty, Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k233199/ 2024-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k233199-rosa-shoulder-system-fda-510k.jpg K233199 - ROSA® Shoulder System K233199 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthosoft Inc. (d/b/a) Zimmer CAS. Cleared Feb 2024. https://www.510kdatabase.net/k233325/ 2024-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k233325-visionary-optics-scleral-contact-lens-fda-510k.jpg K233325 - Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A) K233325 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Visionary Optics, LLC. Cleared Feb 2024. https://www.510kdatabase.net/k233439/ 2024-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k233439-hd60-series-ultrasound-diagnostic-system-fda-510k.jpg K233439 - HD60 Series Ultrasound Diagnostic System K233439 is a FDA 510(k) cleared radiology medical device. Manufacturer: Qingdao Hisense Medical Equipment Co., Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k240194/ 2024-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k240194-procinch-quadcinch-fda-510k.jpg K240194 - ProCinch, QuadCinch K240194 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Riverpoint Medical. Cleared Feb 2024. https://www.510kdatabase.net/den230064/ 2024-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/den230064-braide-embolization-assist-device-fda-510k.jpg DEN230064 - BraidE Embolization Assist Device DEN230064 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Rapid Medical , Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k231896/ 2024-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k231896-diode-laser-therapy-system-fda-510k.jpg K231896 - Diode Laser Therapy System K231896 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Beijing Adss Development Co., Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k233150/ 2024-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k233150-net-brand-osteosynthesis-nailing-system-fda-510k.jpg K233150 - NET BRAND Osteosynthesis Nailing System K233150 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Narang Medical , Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k233194/ 2024-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k233194-ts-abutment-system-fda-510k.jpg K233194 - TS Abutment System K233194 is a FDA 510(k) cleared dental medical device. Manufacturer: Osstem Implant Co., Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k233454/ 2024-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k233454-online-tdm-methotrexate-fda-510k.jpg K233454 - ONLINE TDM Methotrexate K233454 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Operations. Cleared Feb 2024. https://www.510kdatabase.net/k233471/ 2024-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k233471-reprocessed-harmonic-1100-shears-5mm-fda-510k.jpg K233471 - Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120) K233471 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker Sustainability Solutions. Cleared Feb 2024. https://www.510kdatabase.net/k233760/ 2024-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k233760-mjolnir-pro-multielectrode-plasma-fda-510k.jpg K233760 - Mjolnir Pro. (Multi–electrode plasma) K233760 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Leaflife Technology Co., Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k240146/ 2024-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k240146-bd-prevue-ii-peripheral-vascular-fda-510k.jpg K240146 - BD Prevue™ II Peripheral Vascular Access System K240146 is a FDA 510(k) cleared radiology medical device. Manufacturer: Bard Access Systems, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k230235/ 2024-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k230235-medline-luer-lock-syringes-fda-510k.jpg K230235 - Medline Luer Lock Syringes K230235 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, LP. Cleared Feb 2024. https://www.510kdatabase.net/k231453/ 2024-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k231453-snaphammer-hammertoe-correction-system-fda-510k.jpg K231453 - SnapHammer Hammertoe Correction System K231453 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nvision Biomedical Technologies, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k231513/ 2024-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k231513-oral-matrix-fda-510k.jpg K231513 - Oral Matrix K231513 is a FDA 510(k) cleared dental medical device. Manufacturer: Beijing Biosis Healing Biolog Ical Technology Co., Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k231657/ 2024-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k231657-agilon-xo-shoulder-replacement-system-fda-510k.jpg K231657 - AGILON® XO Shoulder Replacement System K231657 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Implantcast GmbH. Cleared Feb 2024. https://www.510kdatabase.net/k231985/ 2024-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k231985-disposable-grounding-pad-fda-510k.jpg K231985 - Disposable Grounding Pad K231985 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Mecun Medical Supply Co., Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k232043/ 2024-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k232043-endoscopic-video-image-processor-rp-fda-510k.jpg K232043 - Endoscopic Video Image Processor (RP-IPD-V2000A, RP-IPD-V2000B, RP-IPD-V2000C, RP-IPD-V2000D), Single-Use Video Gastroscope (RP-GI-G02A, RP-GI-G02B), Single-Use Video Colonoscope (RP-GI-C02A, RP-GI-C02B) K232043 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Guangzhou Red Pine Medical Instrument Co., Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k232087/ 2024-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k232087-dental-lt-comfort-resin-fda-510k.jpg K232087 - Dental LT Comfort Resin K232087 is a FDA 510(k) cleared dental medical device. Manufacturer: Formlabs Ohio, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k232420/ 2024-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k232420-zenition-30-fda-510k.jpg K232420 - Zenition 30 K232420 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Feb 2024. https://www.510kdatabase.net/k232645/ 2024-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k232645-airgle-room-air-purifier-fda-510k.jpg K232645 - Airgle Room Air Purifier K232645 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Airgle Corporation. Cleared Feb 2024. https://www.510kdatabase.net/k232771/ 2024-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k232771-montage-flowable-settable-resorbable-fda-510k.jpg K232771 - Montage Flowable Settable, Resorbable Bone Paste K232771 is a FDA 510(k) cleared neurology medical device. Manufacturer: Orthocon, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k233652/ 2024-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k233652-contour-handwrist-q7000232-fda-510k.jpg K233652 - Contour Hand/Wrist (Q7000232) K233652 is a FDA 510(k) cleared radiology medical device. Manufacturer: Quality Electrodynamics. Cleared Feb 2024. https://www.510kdatabase.net/k233658/ 2024-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k233658-biowy-tym-tube-tt-fda-510k.jpg K233658 - Biowy Tym Tube (TT) K233658 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Biowy Corporation. Cleared Feb 2024. https://www.510kdatabase.net/k233708/ 2024-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k233708-navigo-12f-steerable-intracardiac-fda-510k.jpg K233708 - NaviGo 12F Steerable Intracardiac Catheter Introducer Kit (S12FS-01) K233708 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Synaptic Medical Corporation. Cleared Feb 2024. https://www.510kdatabase.net/k233906/ 2024-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k233906-s-patch-s-patch-exl-fda-510k.jpg K233906 - S-Patch (S-Patch ExL) K233906 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Wellysis Corp.. Cleared Feb 2024. https://www.510kdatabase.net/k234005/ 2024-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k234005-access-ck-mb-fda-510k.jpg K234005 - Access CK-MB K234005 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k240119/ 2024-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k240119-vasq-fda-510k.jpg K240119 - VasQ K240119 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Laminate Medical Technologies , Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k240137/ 2024-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k240137-cranial-loop-cranial-loop-l-and-fda-510k.jpg K240137 - Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System K240137 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neos Surgery S.L. Cleared Feb 2024. https://www.510kdatabase.net/k240148/ 2024-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k240148-scig60-infusion-system-fda-510k.jpg K240148 - SCIg60 Infusion System K240148 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Emed Technologies Corporation. Cleared Feb 2024. https://www.510kdatabase.net/k222917/ 2024-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k222917-breathing-circuit-bacterialviral-filter-fda-510k.jpg K222917 - Breathing circuit bacterial/viral filter K222917 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shaoxing Haitech Medical Products Co., Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k223493/ 2024-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k223493-pbc-separator-with-selux-ast-system-fda-510k.jpg K223493 - PBC Separator with Selux AST System K223493 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Selux Diagnostics, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k231107/ 2024-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k231107-bronchoscope-system-fda-510k.jpg K231107 - Bronchoscope System K231107 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Hunan Endoso Life Technology Co., Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k231522/ 2024-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k231522-emphasys-dual-mobility-system-fda-510k.jpg K231522 - EMPHASYS™ Dual Mobility System K231522 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Ireland UC. Cleared Feb 2024. https://www.510kdatabase.net/k231659/ 2024-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k231659-ms55-plus-digital-color-doppler-fda-510k.jpg K231659 - MS55 Plus Digital Color Doppler Ultrasound System (MS55) K231659 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medisono. Cleared Feb 2024. https://www.510kdatabase.net/k232245/ 2024-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k232245-veddilator-tm-3-stage-balloon-dilation-fda-510k.jpg K232245 - VedDilator ^TM (3-Stage Balloon Dilation Catheter) K232245 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Jiangsu Vedkang Medical Science and Technology Co., Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k232915/ 2024-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k232915-epimonitor-fda-510k.jpg K232915 - EpiMonitor K232915 is a FDA 510(k) cleared neurology medical device. Manufacturer: Empatica S.R.L.. Cleared Feb 2024. https://www.510kdatabase.net/k233483/ 2024-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k233483-freedomflow-orbital-circumferential-fda-510k.jpg K233483 - FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration) K233483 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cardio Flow Inc.,. Cleared Feb 2024. https://www.510kdatabase.net/k233656/ 2024-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k233656-contour-shoulder-fda-510k.jpg K233656 - Contour Shoulder K233656 is a FDA 510(k) cleared radiology medical device. Manufacturer: Quality Electrodynamics. Cleared Feb 2024. https://www.510kdatabase.net/k234028/ 2024-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k234028-copal-exchange-g-hip-spacer-fda-510k.jpg K234028 - COPAL® exchange G hip spacer K234028 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Heraeus Medical GmbH. Cleared Feb 2024. https://www.510kdatabase.net/k234036/ 2024-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k234036-sonik-monark-100-fda-510k.jpg K234036 - SONIK MONARK 100 K234036 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Neuro Spinal Innovation, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k240130/ 2024-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k240130-medical-monitor-21hq613d-fda-510k.jpg K240130 - Medical Monitor (21HQ613D) K240130 is a FDA 510(k) cleared radiology medical device. Manufacturer: Lg Electronics.Inc. Cleared Feb 2024. https://www.510kdatabase.net/k240157/ 2024-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k240157-invision-15-surgical-theatre-fda-510k.jpg K240157 - InVision™ 1.5 Surgical Theatre K240157 is a FDA 510(k) cleared radiology medical device. Manufacturer: Deerfield Imaging, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k231514/ 2024-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k231514-azure-fda-510k.jpg K231514 - Azure K231514 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Daeshin Enterprise Co., Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k233678/ 2024-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k233678-radiography-7000-m-fda-510k.jpg K233678 - Radiography 7000 M K233678 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Dmc GmbH. Cleared Feb 2024. https://www.510kdatabase.net/k240427/ 2024-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k240427-airvata-fda-510k.jpg K240427 - airVata™ K240427 is a FDA 510(k) cleared dental medical device. Manufacturer: Gelb Practice Solutions, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k231134/ 2024-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k231134-verteloc-spinal-system-fda-510k.jpg K231134 - VerteLoc Spinal System K231134 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Signature Orthopaedics Pty, Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k231855/ 2024-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k231855-qoca-image-smart-rt-contouring-system-fda-510k.jpg K231855 - QOCA® image Smart RT Contouring System K231855 is a FDA 510(k) cleared radiology medical device. Manufacturer: Quanta Computer, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k231990/ 2024-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k231990-apex-locator-fda-510k.jpg K231990 - Apex Locator K231990 is a FDA 510(k) cleared dental medical device. Manufacturer: Cefla S.C.. Cleared Feb 2024. https://www.510kdatabase.net/k232082/ 2024-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k232082-expd-4343s-fda-510k.jpg K232082 - EXPD 4343S K232082 is a FDA 510(k) cleared radiology medical device. Manufacturer: DRTECH Corporation. Cleared Feb 2024. https://www.510kdatabase.net/k233661/ 2024-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k233661-transorb-self-gripping-resorbable-mesh-fda-510k.jpg K233661 - Transorb™ Self-Gripping Resorbable Mesh K233661 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sofradim Production. Cleared Feb 2024. https://www.510kdatabase.net/k233740/ 2024-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k233740-black-nitrile-powder-free-patient-fda-510k.jpg K233740 - Black Nitrile Powder Free Patient Examination Glove, Non Sterile K233740 is a FDA 510(k) cleared general hospital medical device. Manufacturer: W.A. Rubbermate Co., Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k233788/ 2024-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k233788-epiq-series-diagnostic-ultrasound-fda-510k.jpg K233788 - EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System K233788 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Ultrasound, LLC. Cleared Feb 2024. https://www.510kdatabase.net/k233954/ 2024-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k233954-chemi-sil-hb-mb-lb-lbs-fda-510k.jpg K233954 - Chemi-SiL (HB, MB, LB, LBS) K233954 is a FDA 510(k) cleared dental medical device. Manufacturer: B&E Korea Co., Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k233959/ 2024-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k233959-epi-ease-epicardial-access-device-eas-fda-510k.jpg K233959 - EPi-Ease Epicardial Access Device (EAS) K233959 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: AtriCure, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k234048/ 2024-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k234048-must-pedicle-screw-system-extension-fda-510k.jpg K234048 - M.U.S.T. Pedicle Screw System - Extension K234048 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Feb 2024. https://www.510kdatabase.net/k234123/ 2024-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k234123-easi-vue-embolic-microspheres-system-fda-510k.jpg K234123 - Easi-Vue® embolic microspheres System K234123 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abk Biomedical, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k231468/ 2024-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k231468-scout-md-surgical-guidance-system-fda-510k.jpg K231468 - SCOUT MD Surgical Guidance System K231468 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Merit Medical System, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k232003/ 2024-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k232003-endoscopic-video-image-processor-fda-510k.jpg K232003 - Endoscopic Video Image Processor, Single-Use Video Hysteroscope K232003 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Guangzhou Red Pine Medical Instrument Co., Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k232674/ 2024-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k232674-painfreeze-ii-fda-510k.jpg K232674 - PainFreeze II K232674 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Nuance Medical, LLC. Cleared Feb 2024. https://www.510kdatabase.net/k233040/ 2024-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k233040-emstens-massager-device-fda-510k.jpg K233040 - EMS/TENS Massager Device K233040 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Shenzhen Imdk Medical Technology Co., Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k233092/ 2024-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k233092-pain-therapy-device-sm9075-sm9910-fda-510k.jpg K233092 - Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W) K233092 is a FDA 510(k) cleared neurology medical device. Manufacturer: Chongqing Rob Linka Science and Technology Co., Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k233134/ 2024-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k233134-its-ins-proximal-femur-nail-fda-510k.jpg K233134 - I.T.S. INS Proximal Femur Nail K233134 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: I.T.S. GmbH. Cleared Feb 2024. https://www.510kdatabase.net/k233217/ 2024-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k233217-mimics-cardiac-planner-fda-510k.jpg K233217 - Mimics Cardiac Planner K233217 is a FDA 510(k) cleared radiology medical device. Manufacturer: Materialise NV. Cleared Feb 2024. https://www.510kdatabase.net/k233260/ 2024-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k233260-univers-revers-ca-head-and-adapter-fda-510k.jpg K233260 - Univers Revers CA Head and Adapter K233260 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k233401/ 2024-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k233401-portable-liver-elastography-ultrasound-fda-510k.jpg K233401 - Portable Liver Elastography Ultrasound Diagnostic System (Liverscan Mobile) K233401 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eieling Technology Limited. Cleared Feb 2024. https://www.510kdatabase.net/k233533/ 2024-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k233533-nervetape-fda-510k.jpg K233533 - NerveTape K233533 is a FDA 510(k) cleared neurology medical device. Manufacturer: Biocircuit Technologies, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k233635/ 2024-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k233635-spy-cystoscopehysteroscope-fda-510k.jpg K233635 - SPY Cystoscope/Hysteroscope K233635 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Stryker Endoscopy. Cleared Feb 2024. https://www.510kdatabase.net/k233667/ 2024-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k233667-facial-toning-device-uic-189-fda-510k.jpg K233667 - Facial Toning device (UIC-189) K233667 is a FDA 510(k) cleared neurology medical device. Manufacturer: Body Trim Industrial Co., Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k231355/ 2024-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k231355-aurora-fda-510k.jpg K231355 - Aurora K231355 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Ensodata. Cleared Feb 2024. https://www.510kdatabase.net/k231733/ 2024-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k231733-neteera-130h-plus-vital-sign-fda-510k.jpg K231733 - Neteera 130H-Plus Vital Sign Monitoring Sensor K231733 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Neteera Technologies , Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k232072/ 2024-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k232072-amica-gen-agn-h-13-amica-gen-agn-33-fda-510k.jpg K232072 - AMICA-GEN AGN-H-1.3, AMICA-GEN AGN 3.3, AMICA-PROBE 17G & 18G K232072 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: H.S Hospital Service S.P.A. Cleared Feb 2024. https://www.510kdatabase.net/k232473/ 2024-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k232473-infrared-thermometer-model-yj600-fda-510k.jpg K232473 - Infrared Thermometer: Model YJ600 K232473 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zhuhai Yueja Medical Device Technology Co., Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k233464/ 2024-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k233464-wsa-self-fitting-hearing-aid-gen-2-fda-510k.jpg K233464 - WSA Self-Fitting Hearing Aid Gen 2 K233464 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Wsaud A/S. Cleared Feb 2024. https://www.510kdatabase.net/k233631/ 2024-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k233631-zapstim-controller-application-z1023-fda-510k.jpg K233631 - ZapStim Controller Application (Z1023) K233631 is a FDA 510(k) cleared neurology medical device. Manufacturer: Revital Lab, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k233638/ 2024-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k233638-verza-high-speed-drills-fda-510k.jpg K233638 - VERZA™ High Speed Drills K233638 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k234034/ 2024-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k234034-venacore-thrombectomy-catheter-46-101-fda-510k.jpg K234034 - VenaCore Thrombectomy Catheter (46-101) K234034 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inari Medical, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k234037/ 2024-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k234037-cats-l-tonometer-prism-fda-510k.jpg K234037 - CATS-L Tonometer™ Prism K234037 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Cats Tonometer, LLC. Cleared Feb 2024. https://www.510kdatabase.net/k240066/ 2024-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k240066-fine-osteotomy-fda-510k.jpg K240066 - Fine Osteotomy™ K240066 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Bodycad Laboratories, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k240072/ 2024-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k240072-powder-free-nitrile-examination-gloves-fda-510k.jpg K240072 - Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested For Use With Chemotherapy Drugs and Fentanyl Citrate K240072 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Luliang Hongruida Health Protection Technology Co., Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k240084/ 2024-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k240084-v-strut-vertebral-implant-fda-510k.jpg K240084 - V-STRUT® Vertebral Implant K240084 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Hyprevention. Cleared Feb 2024. https://www.510kdatabase.net/k240098/ 2024-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k240098-defendo-single-use-valve-kit-aws-fda-510k.jpg K240098 - DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS (00711900) K240098 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: STERIS Corporation. Cleared Feb 2024. https://www.510kdatabase.net/k230839/ 2024-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k230839-concentriq-dx-fda-510k.jpg K230839 - Concentriq Dx K230839 is a FDA 510(k) cleared pathology medical device. Manufacturer: Proscia, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k231536/ 2024-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k231536-equant-system-fda-510k.jpg K231536 - eQUANT System K231536 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Avails Medical, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k231575/ 2024-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k231575-vecttor-vt-300-fda-510k.jpg K231575 - Vecttor VT-300 K231575 is a FDA 510(k) cleared neurology medical device. Manufacturer: Artaflex, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k231662/ 2024-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k231662-aid-u-fda-510k.jpg K231662 - Aid-U K231662 is a FDA 510(k) cleared radiology medical device. Manufacturer: Iaid. Cleared Feb 2024. https://www.510kdatabase.net/k231913/ 2024-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k231913-t-fit-fda-510k.jpg K231913 - T-FIT K231913 is a FDA 510(k) cleared dental medical device. Manufacturer: Techwin Co., Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k232644/ 2024-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k232644-neuro42-mri-system-fda-510k.jpg K232644 - neuro42 MRI System K232644 is a FDA 510(k) cleared radiology medical device. Manufacturer: Neuro42, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k232854/ 2024-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k232854-leksell-gammaplan-lgp-fda-510k.jpg K232854 - Leksell GammaPlan (LGP) K232854 is a FDA 510(k) cleared radiology medical device. Manufacturer: Elekta Solutions AB. Cleared Feb 2024. https://www.510kdatabase.net/k233024/ 2024-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k233024-alma-harmony-fda-510k.jpg K233024 - Alma Harmony K233024 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Alma Lasers, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k233080/ 2024-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k233080-healthfld-fda-510k.jpg K233080 - HealthFLD K233080 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nano-X AI , Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k233184/ 2024-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k233184-t2bacteria-panel-fda-510k.jpg K233184 - T2Bacteria® Panel K233184 is a FDA 510(k) cleared microbiology medical device. Manufacturer: T2biosystems, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k233350/ 2024-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k233350-sinc-support-catheter-fda-510k.jpg K233350 - SINC Support Catheter K233350 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Reflow Medical, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k233476/ 2024-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k233476-z1-hip-system-fda-510k.jpg K233476 - Z1 Hip System K233476 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orchard Medical Development. Cleared Feb 2024. https://www.510kdatabase.net/k233480/ 2024-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k233480-access-shbg-fda-510k.jpg K233480 - Access SHBG K233480 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k233504/ 2024-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k233504-lexa-mini-ris-303-ris-305-fda-510k.jpg K233504 - Lexa MINI (RIS-303, RIS-305) K233504 is a FDA 510(k) cleared general hospital medical device. Manufacturer: W&H Sterilization S.R.L.. Cleared Feb 2024. https://www.510kdatabase.net/k233914/ 2024-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k233914-xvbeam2000-fda-510k.jpg K233914 - XVbeam2000 K233914 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Xpectvision Technology Co., Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k240069/ 2024-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k240069-endolumik-gastric-calibration-tube-m-fda-510k.jpg K240069 - Endolumik Gastric Calibration Tube M Series (EGCT36M) K240069 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Endolumik. Cleared Feb 2024. https://www.510kdatabase.net/k240086/ 2024-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k240086-ion-3d-fda-510k.jpg K240086 - Ion 3D K240086 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SurGenTec, LLC. Cleared Feb 2024. https://www.510kdatabase.net/k231956/ 2024-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k231956-fp-optiflow-duet-nasal-cannula-fda-510k.jpg K231956 - F&P Optiflow+ Duet Nasal Cannula K231956 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Fisher &Paykel Healthcare , Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k232171/ 2024-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k232171-purema-h-hemoconcentrator-eto-sterilized-fda-510k.jpg K232171 - Purema® H Hemoconcentrator (EtO Sterilized) K232171 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Tecnoideal America. Cleared Feb 2024. https://www.510kdatabase.net/k232764/ 2024-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k232764-cornflower-blue-powder-free-nitrile-fda-510k.jpg K232764 - Cornflower Blue Powder Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate K232764 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Eco Medi Glove Sdn. Bhd.. Cleared Feb 2024. https://www.510kdatabase.net/k240064/ 2024-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k240064-hair-boom-air-ulike-hair-upup-hair-fda-510k.jpg K240064 - Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair Boom K240064 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wontech Co., Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k240075/ 2024-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k240075-fujifilm-endoscope-model-eb-710xt-fda-510k.jpg K240075 - FUJIFILM Endoscope Model EB-710XT K240075 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Fujifilm Healthcare Americas Corporation. Cleared Feb 2024. https://www.510kdatabase.net/k232057/ 2024-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k232057-bhlmann-fcal-turbo-and-calex-cap-fda-510k.jpg K232057 - BÜHLMANN fCAL® turbo and CALEX® Cap K232057 is a FDA 510(k) cleared immunology medical device. Manufacturer: B?hlmann Laboratories AG. Cleared Feb 2024. https://www.510kdatabase.net/k233115/ 2024-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k233115-hawkeye-control-unit-with-eyas-endoscope-fda-510k.jpg K233115 - Hawkeye Control Unit with Eyas Endoscope K233115 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: E Surgical, LLC. Cleared Feb 2024. https://www.510kdatabase.net/k233221/ 2024-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k233221-metro-soft-silicone-hydrogel-daily-fda-510k.jpg K233221 - Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) K233221 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Metro Optics of Austin, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k233416/ 2024-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k233416-cryojet-plus-she-acp001-1-fda-510k.jpg K233416 - Cryojet Plus (SHE-ACP001-1) K233416 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Beijing Sano Laser S&T Development Co.,Ltd. Cleared Feb 2024. https://www.510kdatabase.net/k233593/ 2024-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k233593-magec-spinal-bracing-and-distraction-fda-510k.jpg K233593 - MAGEC Spinal Bracing and Distraction System K233593 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nuvasive Specialized Orthopedics, Incorporated. Cleared Feb 2024. https://www.510kdatabase.net/k233897/ 2024-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k233897-5mp-color-lcd-monitors-5mp-monochrome-fda-510k.jpg K233897 - 5MP Color LCD Monitors/ 5MP Monochrome LCD Monitors (C510S, G510S, CB5MP, MB5MP, C516S, G516S) K233897 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Beacon Display Technology Co., Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k233960/ 2024-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k233960-innoverse-spinal-system-fda-510k.jpg K233960 - INNOVERSE Spinal System K233960 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Innosys Co., Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/den230041/ 2024-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/den230041-sleep-apnea-feature-fda-510k.jpg DEN230041 - Sleep Apnea Feature DEN230041 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Samsung Electronics Co., Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k232363/ 2024-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k232363-viz-hds-viz-volume-plus-viz-ich-fda-510k.jpg K232363 - Viz HDS, Viz Volume Plus, Viz ICH+ K232363 is a FDA 510(k) cleared radiology medical device. Manufacturer: Viz. Ai, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k232379/ 2024-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k232379-prevent-kit-fda-510k.jpg K232379 - PREVENT Kit K232379 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Clear Choice Therapeutics. Cleared Feb 2024. https://www.510kdatabase.net/k232694/ 2024-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k232694-central-monitoring-system-mfm-cms-fda-510k.jpg K232694 - Central Monitoring System (MFM-CMS) K232694 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edan Instruments, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k233174/ 2024-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k233174-fastep-pregnancy-rapid-test-strip-fda-510k.jpg K233174 - FaStep™ Pregnancy Rapid Test Strip K233174 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Assure Tech. (Hangzhou) Co, Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k233600/ 2024-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k233600-smart-fit-knee-30t-fda-510k.jpg K233600 - Smart Fit Knee 3.0T K233600 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Healthcare (Suzhou) Co., Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k233895/ 2024-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k233895-ez-glide-aortic-perfusion-cannulae-fda-510k.jpg K233895 - EZ Glide Aortic Perfusion Cannulae (EZC21A, EZC21TA, EZC24A, EZC24TA, EZF21A, EZF21TA, EZF24A, EZF24TA, EZS21A, EZS21TA, EZS24A and EZS24TA) K233895 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences. Cleared Feb 2024. https://www.510kdatabase.net/k234013/ 2024-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k234013-mg-osteoinject-fda-510k.jpg K234013 - Mg OSTEOINJECT™ K234013 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Bone Solutions, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k234075/ 2024-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k234075-flow-nail-fda-510k.jpg K234075 - Flow-Nail K234075 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Flow-Fx, LLC. Cleared Feb 2024. https://www.510kdatabase.net/k240099/ 2024-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k240099-ziehm-vision-rfd-fda-510k.jpg K240099 - Ziehm Vision RFD K240099 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ziehm Imaging GmbH. Cleared Feb 2024. https://www.510kdatabase.net/k232210/ 2024-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k232210-x-trodes-system-m-fda-510k.jpg K232210 - X-trodes System M K232210 is a FDA 510(k) cleared neurology medical device. Manufacturer: X-Trodes. Cleared Feb 2024. https://www.510kdatabase.net/k232890/ 2024-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k232890-cerelink-icp-monitor-826820-cerelink-fda-510k.jpg K232890 - CereLink ICP Monitor (826820), CereLink ICP Extension Cable (826845) K232890 is a FDA 510(k) cleared neurology medical device. Manufacturer: Integra Lifesciences Production Corporation. Cleared Feb 2024. https://www.510kdatabase.net/k230548/ 2024-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k230548-myoaligner-appliance-fda-510k.jpg K230548 - Myoaligner Appliance K230548 is a FDA 510(k) cleared dental medical device. Manufacturer: Myohealth Technologies, LLC. Cleared Feb 2024. https://www.510kdatabase.net/k231325/ 2024-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k231325-corplex-p-theracor-p-allacor-p-fda-510k.jpg K231325 - Corplex P / Theracor P / Allacor P K231325 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stimlabs, LLC. Cleared Feb 2024. https://www.510kdatabase.net/k231373/ 2024-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k231373-bd-vacutainer-k2-edta-blood-collection-fda-510k.jpg K231373 - BD Vacutainer® K2 EDTA Blood Collection Tubes K231373 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Becton, Dickinson and Company. Cleared Feb 2024. https://www.510kdatabase.net/k231534/ 2024-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k231534-5008x-hemodialysis-system-fda-510k.jpg K231534 - 5008X Hemodialysis System K231534 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fresenius Medical Care. Cleared Feb 2024. https://www.510kdatabase.net/k231625/ 2024-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k231625-vitaldetect-fda-510k.jpg K231625 - VitalDetect K231625 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Wellvii, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k233143/ 2024-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k233143-pixel8-reveal-fda-510k.jpg K233143 - PiXel8-Reveal K233143 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Rohrer Aesthetics. Cleared Feb 2024. https://www.510kdatabase.net/k233472/ 2024-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k233472-cvac-aspiration-system-cvac-image-fda-510k.jpg K233472 - CVAC Aspiration System + CVAC Image Processor K233472 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Calyxo, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k233531/ 2024-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k233531-oic-flex-fix-system-fda-510k.jpg K233531 - OIC FLEX-FIX™ System K233531 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthopaedic Implant Company. Cleared Feb 2024. https://www.510kdatabase.net/k233756/ 2024-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k233756-artemis-diode-laser-system-rl-s20s-twc-fda-510k.jpg K233756 - Artemis Diode Laser System (RL-S20S-TWC, RL-S20S-810B, RL-S20S-755) K233756 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Rhein Laser Technologies Co., Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k233855/ 2024-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k233855-allpep-fda-510k.jpg K233855 - AllPEP K233855 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Enchant Tek Co. , Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k240030/ 2024-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k240030-indigo-aspiration-system-lightning-flash-fda-510k.jpg K240030 - Indigo® Aspiration System - Lightning® Flash K240030 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Penumbra, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k230657/ 2024-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k230657-btl-99-oc-fda-510k.jpg K230657 - BTL-99-OC K230657 is a FDA 510(k) cleared neurology medical device. Manufacturer: BTL Industries, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k232007/ 2024-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k232007-caas-mr-solutions-fda-510k.jpg K232007 - CAAS MR Solutions K232007 is a FDA 510(k) cleared radiology medical device. Manufacturer: Pie Medical Imaging BV. Cleared Feb 2024. https://www.510kdatabase.net/k232165/ 2024-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k232165-sterile-safety-hypodermic-needles-for-fda-510k.jpg K232165 - Sterile Safety Hypodermic Needles for Single Use K232165 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Berpu Medical Technology Co., Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k232339/ 2024-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k232339-augmented-reality-application-fda-510k.jpg K232339 - Augmented Reality Application K232339 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sira Medical, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k232949/ 2024-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k232949-kelowna-gyn-and-crook-prostate-templates-fda-510k.jpg K232949 - Kelowna GYN and Crook Prostate Templates K232949 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k233183/ 2024-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k233183-surgical-gown-40083-fda-510k.jpg K233183 - Surgical Gown (40083) K233183 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ammex-Weida (Hubei) Health and Safety Products Co., Ltd.. Cleared Feb 2024. https://www.510kdatabase.net/k233804/ 2024-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k233804-resonic-rapid-acoustic-pulse-device-fda-510k.jpg K233804 - Resonic Rapid Acoustic Pulse Device K233804 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Zeltiq Aesthetics, Inc.. Cleared Feb 2024. https://www.510kdatabase.net/k240018/ 2024-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k240018-watchman-trusteer-access-system-fda-510k.jpg K240018 - WATCHMAN TruSteer Access System (M635TU90050) K240018 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Feb 2024. https://www.510kdatabase.net/k214115/ 2024-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k214115-mightysat-otc-fda-510k.jpg K214115 - MightySat -OTC K214115 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Masimo Corporation. Cleared Jan 2024. https://www.510kdatabase.net/k231396/ 2024-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k231396-cephx-cephalometric-analysis-software-fda-510k.jpg K231396 - CEPHX- Cephalometric Analysis Software K231396 is a FDA 510(k) cleared radiology medical device. Manufacturer: Orca Dental AI , Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k232678/ 2024-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k232678-digital-thermometer-model-t28-t28l-fda-510k.jpg K232678 - Digital Thermometer, Model T28, T28L K232678 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guangdong Genial Technology Co., Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k233140/ 2024-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k233140-microwave-ablation-device-exceed-s10u-fda-510k.jpg K233140 - Microwave Ablation Device (Exceed S10U) K233140 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Hygea Medical Technology Co., Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k240004/ 2024-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k240004-cardiocurve-steerable-sheath-small-fda-510k.jpg K240004 - CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S ) K240004 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Circa Scientific, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k240025/ 2024-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k240025-clearblue-early-detection-pregnancy-test-fda-510k.jpg K240025 - Clearblue® Early Detection Pregnancy Test K240025 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Spd Swiss Precision Diagnostics GmbH. Cleared Jan 2024. https://www.510kdatabase.net/den210035/ 2024-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/den210035-genius-digital-diagnostics-system-with-fda-510k.jpg DEN210035 - “Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm” DEN210035 is a FDA 510(k) cleared pathology medical device. Manufacturer: Hologic, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k231343/ 2024-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k231343-redemption-duo-hindfoot-nail-system-fda-510k.jpg K231343 - Redemption Duo Hindfoot Nail System K231343 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Vilex, LLC. Cleared Jan 2024. https://www.510kdatabase.net/k231910/ 2024-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k231910-dermrays-revive-fda-510k.jpg K231910 - DermRays Revive K231910 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wuhan Lotuxs Technology Co., Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k232432/ 2024-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k232432-e3d-a-interbody-system-fda-510k.jpg K232432 - E3D™-A Interbody System K232432 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Evolution Spine. Cleared Jan 2024. https://www.510kdatabase.net/k232942/ 2024-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k232942-g-vitri-vitrification-freeze-media-fda-510k.jpg K232942 - G-Vitri™ Vitrification Freeze Media K232942 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Gimbo Medical Technology Shenzhen Co., Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k232986/ 2024-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k232986-varitrax-sternal-circumfixation-system-fda-510k.jpg K232986 - VariTrax Sternal CircumFixation System K232986 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Circumfix Solutions, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k234140/ 2024-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k234140-viva-combo-rf-system-viva-combo-rf-fda-510k.jpg K234140 - VIVA combo RF System (VIVA combo RF System) K234140 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Starmed Co., Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k240020/ 2024-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k240020-ziehm-vision-fd-fda-510k.jpg K240020 - Ziehm Vision FD K240020 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ziehm Imaging GmbH. Cleared Jan 2024. https://www.510kdatabase.net/k230794/ 2024-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k230794-rebuilder-nerve-guidance-conduit-fda-510k.jpg K230794 - Rebuilder Nerve Guidance Conduit K230794 is a FDA 510(k) cleared neurology medical device. Manufacturer: Celestray Biotech Company, LLC.,. Cleared Jan 2024. https://www.510kdatabase.net/k233394/ 2024-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k233394-gem-flow-now-gem2770-fn-fda-510k.jpg K233394 - Gem Flow Now (GEM2770-FN) K233394 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Synovis Micro Companies Alliance. Cleared Jan 2024. https://www.510kdatabase.net/k233224/ 2024-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k233224-epilaser-pro-fda-510k.jpg K233224 - Epilaser Pro K233224 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Epilady 2000, LLC. Cleared Jan 2024. https://www.510kdatabase.net/k231282/ 2024-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k231282-lifeoutcomes-c-quest-blood-culture-fda-510k.jpg K231282 - LifeOutcomes C-Quest™ Blood Culture Sampling Device K231282 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Lifeoutcomes, LLC. Cleared Jan 2024. https://www.510kdatabase.net/k231303/ 2024-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k231303-arm-type-fully-automatic-digital-blood-fda-510k.jpg K231303 - Arm-type Fully Automatic Digital Blood Pressure Monitor K231303 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Joytech Healthcare Co. , Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k231329/ 2024-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k231329-aptima-neisseria-gonorrhoeae-assay-fda-510k.jpg K231329 - Aptima Neisseria gonorrhoeae Assay K231329 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Hologic, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k231715/ 2024-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k231715-mondrian-anterior-lumbar-plate-system-fda-510k.jpg K231715 - MONDRIAN™ Anterior Lumbar Plate System K231715 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ctl Medical Corporation. Cleared Jan 2024. https://www.510kdatabase.net/k231785/ 2024-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k231785-perifit-pump-fda-510k.jpg K231785 - Perifit Pump K231785 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: X6 Innovations. Cleared Jan 2024. https://www.510kdatabase.net/k232182/ 2024-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k232182-one-fil-fda-510k.jpg K232182 - One-Fil K232182 is a FDA 510(k) cleared dental medical device. Manufacturer: Mediclus Co., Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k232450/ 2024-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k232450-disposable-hemostatic-clips-fda-510k.jpg K232450 - Disposable Hemostatic Clips K232450 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Zhejiang Soudon Medical Technology Co., Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k232864/ 2024-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k232864-egens-pregnancy-test-midstream-i-egens-fda-510k.jpg K232864 - EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II K232864 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Nantong Egens Biotechnology Co., Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k233299/ 2024-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k233299-exactechgps-system-fda-510k.jpg K233299 - ExactechGPS® System K233299 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Blue Ortho. Cleared Jan 2024. https://www.510kdatabase.net/k233485/ 2024-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k233485-m-wave-fda-510k.jpg K233485 - M-Wave K233485 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zynex Medical, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k233508/ 2024-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k233508-ifuse-bedrock-granite-implant-system-fda-510k.jpg K233508 - iFuse Bedrock Granite® Implant System K233508 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SI-BONE, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k233598/ 2024-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k233598-powder-free-nitrile-examination-glove-fda-510k.jpg K233598 - Powder Free Nitrile Examination Glove 2.8 Blue Color, Non-Sterile, and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, and Select Other Drugs K233598 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Anhui Intco Medical Products Co., Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k234109/ 2024-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k234109-ziehm-solo-fd-fda-510k.jpg K234109 - Ziehm Solo FD K234109 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ziehm Imaging GmbH. Cleared Jan 2024. https://www.510kdatabase.net/k234116/ 2024-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k234116-trigon-trigon-ha-stand-alone-wedge-fda-510k.jpg K234116 - Trigon Trigon HA Stand-Alone Wedge Fixation System K234116 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nvision Biomedical Technologies. Cleared Jan 2024. https://www.510kdatabase.net/k234118/ 2024-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k234118-centrimag-acute-circulatory-support-fda-510k.jpg K234118 - CentriMag™ Acute Circulatory Support System K234118 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared Jan 2024. https://www.510kdatabase.net/k234145/ 2024-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k234145-visigi-3d-gastric-sizing-tube-fda-510k.jpg K234145 - ViSiGi 3D Gastric Sizing Tube K234145 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boehringer Laboratories. Cleared Jan 2024. https://www.510kdatabase.net/k232417/ 2024-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k232417-mr-q-fda-510k.jpg K232417 - MR Q K232417 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Meridian AG. Cleared Jan 2024. https://www.510kdatabase.net/k232665/ 2024-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k232665-gentlecath-air-for-women-ch10-fda-510k.jpg K232665 - GentleCath Air for Women (CH10) K232665 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Convatec. Cleared Jan 2024. https://www.510kdatabase.net/k232912/ 2024-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k232912-facet-aurora-reusable-lancet-base-fda-510k.jpg K232912 - Facet Aurora Reusable Lancet Base K232912 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Facet Technologies, LLC. Cleared Jan 2024. https://www.510kdatabase.net/k233425/ 2024-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k233425-flextip-bipolar-electrodes-single-use-fda-510k.jpg K233425 - FlexTip Bipolar electrodes single-use (AR-S9805-0028), FlexTip Bipolar electrodes single-use (AR-S9805-0035) K233425 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sutter Medizintechnik GmbH. Cleared Jan 2024. https://www.510kdatabase.net/k233714/ 2024-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k233714-breview-fda-510k.jpg K233714 - BreView K233714 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems SCS. Cleared Jan 2024. https://www.510kdatabase.net/k233735/ 2024-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k233735-adira-lateral-plate-system-fda-510k.jpg K233735 - ADIRA™ Lateral Plate System K233735 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k233893/ 2024-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k233893-alphavent-knotless-sp-peek-anchor-fda-510k.jpg K233893 - AlphaVent Knotless SP PEEK Anchor K233893 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Endoscopy. Cleared Jan 2024. https://www.510kdatabase.net/k234127/ 2024-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k234127-clariti-1-day-multifocal-somofilcon-a-fda-510k.jpg K234127 - Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker K234127 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: CooperVision, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k231290/ 2024-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k231290-optilite-freelite-kappa-free-kit-fda-510k.jpg K231290 - Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit K231290 is a FDA 510(k) cleared immunology medical device. Manufacturer: The Binding Site, Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k231607/ 2024-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k231607-axial3d-cloud-segmentation-service-fda-510k.jpg K231607 - Axial3D Cloud Segmentation Service K231607 is a FDA 510(k) cleared radiology medical device. Manufacturer: Axial Medical Printing Limited. Cleared Jan 2024. https://www.510kdatabase.net/k233195/ 2024-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k233195-aplio-i900-aplio-i800-and-aplio-i700-fda-510k.jpg K233195 - Aplio i900, Aplio i800 and Aplio i700 Software V8.1 Diagnostic Ultrasound System K233195 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Jan 2024. https://www.510kdatabase.net/k233208/ 2024-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k233208-nobelprocera-titanium-asc-abutment-fda-510k.jpg K233208 - NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium K233208 is a FDA 510(k) cleared dental medical device. Manufacturer: Nobel Biocare AB. Cleared Jan 2024. https://www.510kdatabase.net/k230836/ 2024-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k230836-schursign-tissue-marker-fda-510k.jpg K230836 - SchurSign Tissue Marker K230836 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Surgmark GmbH. Cleared Jan 2024. https://www.510kdatabase.net/k231187/ 2024-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k231187-nano-check-covid-19-antigen-test-fda-510k.jpg K231187 - Nano-Check™ COVID-19 Antigen Test K231187 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Nano-Ditech Corporation. Cleared Jan 2024. https://www.510kdatabase.net/k231305/ 2024-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k231305-endoform-dental-membrane-fda-510k.jpg K231305 - Endoform Dental Membrane K231305 is a FDA 510(k) cleared dental medical device. Manufacturer: Aroa Biosurgery , Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k232673/ 2024-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k232673-dental-glass-ceramics-fda-510k.jpg K232673 - Dental Glass Ceramics K232673 is a FDA 510(k) cleared dental medical device. Manufacturer: Chengdu Besmile Medical Technology Co., Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k232676/ 2024-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k232676-dental-porcelain-powder-fda-510k.jpg K232676 - Dental Porcelain Powder K232676 is a FDA 510(k) cleared dental medical device. Manufacturer: Chengdu Besmile Medical Technology Co., Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k232917/ 2024-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k232917-chemo-mouthpiece-fda-510k.jpg K232917 - Chemo Mouthpiece K232917 is a FDA 510(k) cleared dental medical device. Manufacturer: Chemo Mouthpiece, LLC. Cleared Jan 2024. https://www.510kdatabase.net/k233013/ 2024-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k233013-2-way-100-silicone-cleartract-catheter-fda-510k.jpg K233013 - 2-Way 100% Silicone Cleartract Catheter K233013 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Silq Technologies Corporation. Cleared Jan 2024. https://www.510kdatabase.net/k230841/ 2024-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k230841-naillift-fda-510k.jpg K230841 - NailLift K230841 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Jps Corporation. Cleared Jan 2024. https://www.510kdatabase.net/k231299/ 2024-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k231299-nutricair-enteral-enfit-adapter-enfit-fda-510k.jpg K231299 - Nutricair enteral ENFit adapter: ENFit male – stepped/Christmas tree connector K231299 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cair Lgl. Cleared Jan 2024. https://www.510kdatabase.net/k231423/ 2024-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k231423-combo-electrotherapy-device-models-r-fda-510k.jpg K231423 - Combo Electrotherapy Device (Models: R-C101C, R-C101D, R-C101F, R-C101G, F100, MINI-TENS-COMB, RC101I, TENS3500) K231423 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Roundwhale Technology Co. , Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k233450/ 2024-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k233450-megagen-dental-implant-abutment-scan-fda-510k.jpg K233450 - MegaGen Dental Implant Abutment - Scan Healing Abutment K233450 is a FDA 510(k) cleared dental medical device. Manufacturer: Megagen Implant Co., Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k233887/ 2024-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k233887-ipl-hair-removal-device-ui06pn-ui06-pl-fda-510k.jpg K233887 - IPL Hair Removal Device (UI06PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD, UI08 BR, UI08 DB, UI08 BL, UI08 GP, UI08 PN, UI08 RE, UI08 WH, UI08 PW, UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07 PN, UI07 RE, UI07 WH, UI07 PW, UI20 BR, UI20 DB, UI20 BL, UI20 GP, UI20 PN, UI20 RE, UI20 WH, UI20 PW) K233887 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Ulike Smart Electronics Co., Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k234087/ 2024-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k234087-restor3d-tidal-lumbar-interbody-fusion-fda-510k.jpg K234087 - restor3d TIDAL Lumbar Interbody Fusion System K234087 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Restor3d. Cleared Jan 2024. https://www.510kdatabase.net/k233105/ 2024-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k233105-response-rib-and-pelvic-system-fda-510k.jpg K233105 - RESPONSE™ Rib and Pelvic System K233105 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OrthoPediatrics Corp.. Cleared Jan 2024. https://www.510kdatabase.net/k230133/ 2024-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k230133-plenity-fda-510k.jpg K230133 - Plenity K230133 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Gelesis, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k230524/ 2024-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k230524-cold-compression-wrap-pro-fda-510k.jpg K230524 - Cold Compression Wrap Pro K230524 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Chengdu Cryo-Push Medical Technology Co.,Ltd. Cleared Jan 2024. https://www.510kdatabase.net/k230817/ 2024-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k230817-torpedo-implant-system-fda-510k.jpg K230817 - TORPEDO Implant System® K230817 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Deltacor GmbH. Cleared Jan 2024. https://www.510kdatabase.net/k231071/ 2024-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k231071-mix2vial-transfer-device-fda-510k.jpg K231071 - Mix2Vial® Transfer Device K231071 is a FDA 510(k) cleared general hospital medical device. Manufacturer: West Pharma Services Il, Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k231192/ 2024-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k231192-rightest-blood-glucose-monitoring-fda-510k.jpg K231192 - RIGHTEST Blood Glucose Monitoring System Max Tel K231192 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bionime Corporation. Cleared Jan 2024. https://www.510kdatabase.net/k231213/ 2024-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k231213-hkt-anatomical-locking-trauma-system-fda-510k.jpg K231213 - HKT Anatomical Locking Trauma System K231213 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Hankil Tech Medical Co., Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k231218/ 2024-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k231218-distal-access-catheter-fda-510k.jpg K231218 - Distal Access Catheter K231218 is a FDA 510(k) cleared neurology medical device. Manufacturer: Accumedical Beijing , Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k231237/ 2024-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k231237-bd-vacutainer-fluoride-blood-fda-510k.jpg K231237 - BD Vacutainer® Fluoride Blood Collection Tubes K231237 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Becton, Dickinson and Company. Cleared Jan 2024. https://www.510kdatabase.net/k231873/ 2024-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k231873-depuy-summit-porocoat-hip-prosthesis-fda-510k.jpg K231873 - DePuy SUMMIT Porocoat Hip Prosthesis – MR Conditional, DePuy SUMMIT DuoFix Hip Prosthesis – MR Conditional, DePuy SUMMIT Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT FX Cemented Hip Prosthesis – MR Conditional, DePuy SUMMIT Basic Press-Fit Hip Prosthesis – MR Conditional K231873 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Ireland UC. Cleared Jan 2024. https://www.510kdatabase.net/k232156/ 2024-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k232156-rapid-aspects-v3-fda-510k.jpg K232156 - Rapid ASPECTS (v3) K232156 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ischemaview, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k232347/ 2024-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k232347-magnetos-granules-fda-510k.jpg K232347 - MagnetOs Granules K232347 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Kuros Biosciences B.V. Cleared Jan 2024. https://www.510kdatabase.net/k232466/ 2024-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k232466-electric-breast-pump-model-ym-8166-fda-510k.jpg K232466 - Electric Breast Pump, model: YM-8166 K232466 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Guangdong Youmeng Electrical Technology Co., Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k232679/ 2024-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k232679-cleaner-pro-thrombectomy-system-fda-510k.jpg K232679 - Cleaner™ Pro Thrombectomy System K232679 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Argon Medical Devices, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k232783/ 2024-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k232783-power-wheelchair-model-jmpw-01w-fda-510k.jpg K232783 - Power wheelchair (Model: JMPW-01W) K232783 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Jiangsu Jumao X-Care Medical Equipment Co., Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k233142/ 2024-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k233142-endosign-cell-collection-device-es-cyt-fda-510k.jpg K233142 - EndoSign® Cell collection device (ES-CYT-102) K233142 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cyted Limited. Cleared Jan 2024. https://www.510kdatabase.net/k233436/ 2024-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k233436-illuminoss-photodynamic-bone-fda-510k.jpg K233436 - IlluminOss Photodynamic Bone Stabilization System K233436 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Illuminoss Medical, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k233461/ 2024-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k233461-hi-dow-pro-touch-wireless-6-12-hd-19a-fda-510k.jpg K233461 - Hi-Dow PRO TOUCH WIRELESS 6-12 (HD-19A) K233461 is a FDA 510(k) cleared neurology medical device. Manufacturer: Hi-Dow International, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k233728/ 2024-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k233728-signa-champion-fda-510k.jpg K233728 - SIGNA Champion K233728 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare (Tianjin) Company Limited. Cleared Jan 2024. https://www.510kdatabase.net/k233736/ 2024-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k233736-lifesparc-system-fda-510k.jpg K233736 - LifeSPARC System K233736 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cardiacassist, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/den220009/ 2024-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/den220009-vertouch-spinal-imaging-device-fda-510k.jpg DEN220009 - VerTouch Spinal Imaging Device DEN220009 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Intuitap Medical, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k221866/ 2024-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k221866-s-plant-dental-implant-system-fda-510k.jpg K221866 - S-Plant Dental Implant System K221866 is a FDA 510(k) cleared dental medical device. Manufacturer: Newton Implant Systems, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k230592/ 2024-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k230592-luxcreo-dental-night-guard-resin-fda-510k.jpg K230592 - LuxCreo Dental Night Guard Resin K230592 is a FDA 510(k) cleared dental medical device. Manufacturer: LuxCreo, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k231166/ 2024-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k231166-levina-levina-incontinence-stimulation-fda-510k.jpg K231166 - Levina, Levina Incontinence Stimulation Electrodes (Sterile), Pelvic Floor Muscle Probe Electrodes K231166 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Zmi Electronics , Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k231405/ 2024-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k231405-sterile-single-use-electrosurgical-fda-510k.jpg K231405 - Sterile Single Use Electrosurgical Pencil with Non-Coated Electrode, Sterile Single Use Electrosurgical Pencil with Non-Stick Electrode K231405 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Jiangsu Rong FU Kang Medical Instruments Co., Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k231416/ 2024-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k231416-air-next-nvd-02-fda-510k.jpg K231416 - Air Next (NVD-02) K231416 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Nuvoair AB. Cleared Jan 2024. https://www.510kdatabase.net/k231573/ 2024-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k231573-thinkqa-edition-2-fda-510k.jpg K231573 - ThinkQA (Edition 2) K231573 is a FDA 510(k) cleared radiology medical device. Manufacturer: Dosisoft SA. Cleared Jan 2024. https://www.510kdatabase.net/k231762/ 2024-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k231762-uexplorer-fda-510k.jpg K231762 - uEXPLORER K231762 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k231860/ 2024-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k231860-tdm-screw-system-fda-510k.jpg K231860 - TDM Screw System K231860 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tdm Co., Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k232373/ 2024-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k232373-progrip-self-gripping-polypropylene-mesh-fda-510k.jpg K232373 - Progrip™ Self-Gripping Polypropylene Mesh K232373 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sofradim Production. Cleared Jan 2024. https://www.510kdatabase.net/k232577/ 2024-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k232577-radial-compression-device-fda-510k.jpg K232577 - Radial Compression Device K232577 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ningbo Dizegens Medical Science Co.,Ltd. Cleared Jan 2024. https://www.510kdatabase.net/k232698/ 2024-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k232698-nemoscan-fda-510k.jpg K232698 - NemoScan K232698 is a FDA 510(k) cleared radiology medical device. Manufacturer: Software Nemotec S.L.. Cleared Jan 2024. https://www.510kdatabase.net/k232860/ 2024-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k232860-pentax-medical-video-processor-epk-fda-510k.jpg K232860 - PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10, PENTAX Medical Video Bronchoscope EB15-J10, PENTAX Medical Video Bronchoscope EB19-J10U, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U K232860 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Pentax of America, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k233077/ 2024-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k233077-flashheal-2-flashheal-20-fda-510k.jpg K233077 - FlashHeal 2 (FlashHeal 2.0) K233077 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Inwound Aps. Cleared Jan 2024. https://www.510kdatabase.net/k233190/ 2024-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k233190-enfit-adaptor-fda-510k.jpg K233190 - ENFit Adaptor K233190 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Jiangsu Caina Medical Co.,Ltd. Cleared Jan 2024. https://www.510kdatabase.net/k233213/ 2024-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k233213-nxstage-pureflow-solution-fda-510k.jpg K233213 - NxStage PureFlow Solution K233213 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Nxstage Medical, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k233242/ 2024-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k233242-atellica-ch-high-sensitivity-c-fda-510k.jpg K233242 - Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) K233242 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k233447/ 2024-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k233447-cequr-simplicity-on-demand-insulin-fda-510k.jpg K233447 - CeQur Simplicity™ On-Demand Insulin Delivery System K233447 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Cequr SA. Cleared Jan 2024. https://www.510kdatabase.net/k233451/ 2024-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k233451-arthrex-synergy-vision-endoscopic-fda-510k.jpg K233451 - Arthrex Synergy Vision Endoscopic Imaging System K233451 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Arthrex, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k233507/ 2024-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k233507-evolution-tibial-cones-fda-510k.jpg K233507 - EVOLUTION® Tibial Cones K233507 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Microport Orthopedics, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k233680/ 2024-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k233680-celect-platinum-vena-cava-filter-set-fda-510k.jpg K233680 - Celect Platinum Vena Cava Filter Set for Femoral Vein Approach (IGTCFS-65-1-FEM-CELECT-PT) K233680 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: William Cook Europe Aps. Cleared Jan 2024. https://www.510kdatabase.net/k233744/ 2024-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k233744-curiteva-porous-peek-lumbar-interbody-fda-510k.jpg K233744 - Curiteva Porous PEEK Lumbar Interbody Fusion System K233744 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Curiteva, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k234011/ 2024-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k234011-amf-tt-cones-fda-510k.jpg K234011 - AMF TT Cones K234011 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Lima Corporate S.P.A.. Cleared Jan 2024. https://www.510kdatabase.net/k234031/ 2024-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k234031-medline-unite-ancillary-foot-recon-fda-510k.jpg K234031 - Medline UNITE Ancillary Foot Recon Plating System K234031 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medline Industires, LP. Cleared Jan 2024. https://www.510kdatabase.net/k234040/ 2024-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k234040-trimed-threaded-intramedullary-nail-fda-510k.jpg K234040 - TriMed Threaded Intramedullary Nail System K234040 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: TriMed, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k234051/ 2024-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k234051-minuteman-g5-mis-fusion-plate-fda-510k.jpg K234051 - Minuteman G5 MIS Fusion Plate K234051 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinal Simplicity, LLC. Cleared Jan 2024. https://www.510kdatabase.net/k231135/ 2024-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k231135-video-ureteroscope-system-fda-510k.jpg K231135 - Video Ureteroscope System K231135 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hunan Vathin Medical Instrument Co., Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k231871/ 2024-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k231871-radify-triage-fda-510k.jpg K231871 - Radify Triage K231871 is a FDA 510(k) cleared radiology medical device. Manufacturer: Envisionit Deepai, Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k232732/ 2024-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k232732-rapid-marijuana-thc-test-strip-20-fda-510k.jpg K232732 - Rapid Marijuana (THC) Test Strip 20, Rapid Marijuana (THC) Test Dipcard 20, Rapid Marijuana (THC) Test Strip 50, Rapid Marijuana (THC) Test Dipcard 50 K232732 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Co-Innovation Biotech Co., Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k233031/ 2024-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k233031-mbiopsy-surecore-automatic-disposable-fda-510k.jpg K233031 - M·Biopsy /SureCore Automatic Disposable Biopsy Needle, M·Biopsy /SureCore Semi-automatic Disposable Biopsy Needle, M·Biopsy /SureAim Coaxial Biopsy Needle K233031 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Canyon Medical, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k233226/ 2024-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k233226-flexview-diagnostic-v1120-fda-510k.jpg K233226 - FlexView Diagnostic (v1.1.20) K233226 is a FDA 510(k) cleared radiology medical device. Manufacturer: Radical Imaging, LLC. Cleared Jan 2024. https://www.510kdatabase.net/k233445/ 2024-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k233445-bactiseal-catheters-fda-510k.jpg K233445 - Bactiseal Catheters K233445 is a FDA 510(k) cleared neurology medical device. Manufacturer: Integra Lifesciences Production Corporation. Cleared Jan 2024. https://www.510kdatabase.net/k233710/ 2024-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k233710-symphion-operative-hysteroscopy-system-fda-510k.jpg K233710 - Symphion Operative Hysteroscopy System K233710 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Minerva Surgical, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k233730/ 2024-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k233730-footprint-mini-pk-35mm-suture-anchor-fda-510k.jpg K233730 - Footprint Mini PK, 3.5mm Suture Anchor K233730 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew. Cleared Jan 2024. https://www.510kdatabase.net/k233783/ 2024-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k233783-exgraft-eptfe-vascular-grafts-exgraft-fda-510k.jpg K233783 - exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts K233783 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Peca Labs, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k233988/ 2024-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k233988-cerenovus-large-bore-catheter-fda-510k.jpg K233988 - Cerenovus Large Bore Catheter K233988 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cerenovus, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k234030/ 2024-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k234030-clear-guide-scenergy-fda-510k.jpg K234030 - Clear Guide SCENERGY K234030 is a FDA 510(k) cleared radiology medical device. Manufacturer: Clear Guide Medical. Cleared Jan 2024. https://www.510kdatabase.net/k223234/ 2024-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k223234-delta4-insight-fda-510k.jpg K223234 - Delta4 Insight K223234 is a FDA 510(k) cleared radiology medical device. Manufacturer: Scandidos AB. Cleared Jan 2024. https://www.510kdatabase.net/k223266/ 2024-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k223266-hilzo-esophageal-stents-fda-510k.jpg K223266 - Hilzo Esophageal Stents K223266 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Thoracent, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k231138/ 2024-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k231138-aniti-snore-mouthguard-fda-510k.jpg K231138 - Aniti-Snore Mouthguard+ K231138 is a FDA 510(k) cleared dental medical device. Manufacturer: Oscimed SA. Cleared Jan 2024. https://www.510kdatabase.net/k231144/ 2024-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k231144-washtrays-fda-510k.jpg K231144 - Washtrays K231144 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Dentsply Sirona. Cleared Jan 2024. https://www.510kdatabase.net/k232062/ 2024-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k232062-uni-port-fda-510k.jpg K232062 - Uni-port K232062 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Dalim Medical Corp.. Cleared Jan 2024. https://www.510kdatabase.net/k232355/ 2024-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k232355-non-absorbable-surgical-silk-suture-fda-510k.jpg K232355 - Non absorbable Surgical Silk Suture K232355 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shandong Haidike Medical Product Co., Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k233293/ 2024-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k233293-generation-20-monarch-external-fda-510k.jpg K233293 - Generation 2.0 Monarch external Trigeminal Nerve Stimulation (eTNS) System® K233293 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neurosigma, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k233512/ 2024-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k233512-rapid-60-fda-510k.jpg K233512 - Rapid (6.0) K233512 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ischemaview, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k233796/ 2024-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k233796-disposable-safety-lancet-impress-fda-510k.jpg K233796 - Disposable safety lancet (Impress) K233796 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: SteriLance Medical (Suzhou), Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k233970/ 2024-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k233970-nephron-nitrile-nitrile-powder-free-fda-510k.jpg K233970 - Nephron Nitrile™, Nitrile Powder-Free Examination Blue Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) K233970 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Nephron Nitrile, LLC. Cleared Jan 2024. https://www.510kdatabase.net/k232350/ 2024-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k232350-stryker-facial-id-system-fda-510k.jpg K232350 - Stryker Facial iD System K232350 is a FDA 510(k) cleared dental medical device. Manufacturer: Stryker Craniomaxillofacial. Cleared Jan 2024. https://www.510kdatabase.net/k233216/ 2024-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k233216-clewicu-system-fda-510k.jpg K233216 - CLEWICU System K233216 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Clew Medical , Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k222783/ 2024-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k222783-md-mattress-suture-placement-device-fda-510k.jpg K222783 - MD Mattress Suture Placement Device K222783 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lsi Solutions, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k231315/ 2024-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k231315-velox-power-chair-fda-510k.jpg K231315 - Velox Power Chair K231315 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Velox Manufacturing, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k231371/ 2024-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k231371-bee-cervical-cage-fda-510k.jpg K231371 - BEE Cervical Cage K231371 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: NGMedical GmbH. Cleared Jan 2024. https://www.510kdatabase.net/k231558/ 2024-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k231558-smb-luer-lock-disposable-syringe-fda-510k.jpg K231558 - SMB Luer lock disposable syringe K231558 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Smb Corporation of India. Cleared Jan 2024. https://www.510kdatabase.net/k231684/ 2024-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k231684-quick-radius-disposable-set-fda-510k.jpg K231684 - Quick - Radius Disposable Set K231684 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: GM Dos Reis Industria e Comercio Ltda.. Cleared Jan 2024. https://www.510kdatabase.net/k231820/ 2024-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k231820-solosmart-injection-pen-adapter-fda-510k.jpg K231820 - SoloSmart Injection Pen Adapter (SoloSmart®) K231820 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Biocorp Production. Cleared Jan 2024. https://www.510kdatabase.net/k231970/ 2024-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k231970-pentax-medical-single-use-video-fda-510k.jpg K231970 - PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video Bronchoscope EB15-S01, PENTAX Medical Mobile Processor ONE-M, PENTAX Medical Mobile Processor Plug-In ONE-Dock K231970 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Pentax of America, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k232032/ 2024-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k232032-probeat-fr-fda-510k.jpg K232032 - PROBEAT-FR K232032 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha. Cleared Jan 2024. https://www.510kdatabase.net/k232170/ 2024-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k232170-ti-link-abutment-fda-510k.jpg K232170 - Ti Link Abutment K232170 is a FDA 510(k) cleared dental medical device. Manufacturer: Izenimplant Co., Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k232615/ 2024-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k232615-lumimark-biopsy-site-marker-lm0215t-fda-510k.jpg K232615 - LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)) K232615 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Devicor Medical Products, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k232970/ 2024-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k232970-hem-o-lok-ligating-clips-fda-510k.jpg K232970 - Hem-o-lok® Ligating Clips K232970 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Teleflex Medical. Cleared Jan 2024. https://www.510kdatabase.net/k232990/ 2024-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k232990-atomic-nitinol-fixation-system-fda-510k.jpg K232990 - A’TOMIC™ Nitinol Fixation System K232990 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Rmr Ortho, LLC. Cleared Jan 2024. https://www.510kdatabase.net/k233020/ 2024-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k233020-tautona-pneumoperitoneum-assist-device-fda-510k.jpg K233020 - TauTona Pneumoperitoneum Assist Device (TPAD) K233020 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Tautona Group Research & Development, Co., LLC. Cleared Jan 2024. https://www.510kdatabase.net/k233022/ 2024-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k233022-halyard-fluidshield-3-n95-particulate-fda-510k.jpg K233022 - Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 3 N95 Particulate Filter Respirator and Surgical Mask with Safety Seal and So Soft Lining, Orange, Regular and Small, Halyard Fluidshield 2 N95 Particulate Filter Respirator and Surgical Mask with So Soft Lining, White, Regular and Small K233022 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Owens & Minor (O&M) Halyard, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k233114/ 2024-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k233114-led-silicone-mask-model-lp-rvtglwp-wht-fda-510k.jpg K233114 - LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200) K233114 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Idea Light Limited. Cleared Jan 2024. https://www.510kdatabase.net/k233125/ 2024-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k233125-zirconia-block-fda-510k.jpg K233125 - Zirconia Block K233125 is a FDA 510(k) cleared dental medical device. Manufacturer: Hangzhou Ivista Medical Devices Co., Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k233141/ 2024-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k233141-smartframe-or-fda-510k.jpg K233141 - SmartFrame OR K233141 is a FDA 510(k) cleared neurology medical device. Manufacturer: ClearPoint Neuro, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k233144/ 2024-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k233144-clearpoint-bone-screw-fiducials-fda-510k.jpg K233144 - ClearPoint Bone Screw Fiducials K233144 is a FDA 510(k) cleared neurology medical device. Manufacturer: ClearPoint Neuro, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k233155/ 2024-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k233155-clearpointer-optical-navigation-wand-fda-510k.jpg K233155 - ClearPointer Optical Navigation Wand K233155 is a FDA 510(k) cleared neurology medical device. Manufacturer: ClearPoint Neuro, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k233355/ 2024-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k233355-cypris-exact-suturing-system-fda-510k.jpg K233355 - Cypris eXact Suturing System K233355 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cypris Medical. Cleared Jan 2024. https://www.510kdatabase.net/k233520/ 2024-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k233520-powder-free-non-sterile-blue-nitrile-fda-510k.jpg K233520 - Powder free, Non-sterile, Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs and Fentanyl K233520 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Anhui Powerguard Technology Co., Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k233677/ 2024-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k233677-biograph-vk10-fda-510k.jpg K233677 - Biograph VK10 K233677 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k233694/ 2024-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k233694-meridian-interbody-system-fda-510k.jpg K233694 - Meridian Interbody System K233694 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared Jan 2024. https://www.510kdatabase.net/k233964/ 2024-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k233964-gi-genius-module-100-ggm100us-fda-510k.jpg K233964 - GI Genius™ Module 100 (GGM100.US) K233964 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cosmo Artificial Intelligence - Ai, Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/den220040/ 2024-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/den220040-fibresolve-fda-510k.jpg DEN220040 - Fibresolve DEN220040 is a FDA 510(k) cleared radiology medical device. Manufacturer: Imvaria, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/den230008/ 2024-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/den230008-dermasensor-fda-510k.jpg DEN230008 - DermaSensor DEN230008 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Dermasensor, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/den230015/ 2024-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/den230015-osteoboost-belt-fda-510k.jpg DEN230015 - Osteoboost Belt DEN230015 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Bone Health Technologies, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k222929/ 2024-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k222929-toxiseal-vial-adapter-with-external-fda-510k.jpg K222929 - ToxiSeal Vial Adapter with External Balloon K222929 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Epic Medical Pte. , Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k231088/ 2024-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k231088-copper-foam-dressing-prescription-and-fda-510k.jpg K231088 - Copper Foam Dressing (Prescription and OTC) K231088 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Roosin Medical Co., Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k231633/ 2024-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k231633-disposable-hemoclip-af-series-fda-510k.jpg K231633 - Disposable Hemoclip (AF series) K231633 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Alton (Shanghai) Medical Instruments Co., Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k231774/ 2024-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k231774-coralview-single-use-digital-flexible-fda-510k.jpg K231774 - CoralView® Single-use Digital Flexible Ureteroscope (U10) K231774 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: MacroLux Medical Technology Co., Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k232250/ 2024-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k232250-surgicount-system-fda-510k.jpg K232250 - SurgiCount+ System K232250 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker Instruments. Cleared Jan 2024. https://www.510kdatabase.net/k232285/ 2024-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k232285-u-lite-pro-fda-510k.jpg K232285 - U-Lite PRO K232285 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sonoscanner Sarl. Cleared Jan 2024. https://www.510kdatabase.net/k232995/ 2024-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k232995-neurological-therapy-devices-fda-510k.jpg K232995 - Neurological Therapy Devices - Accessories: Electrotherapy device Electrode belt for Abdominal Muscle Trainer Toning, AC1001, AC1002, AC1003, AC1003, AC1004, AC1005 K232995 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Roundwhale Technology Co. , Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k233616/ 2024-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k233616-clevaligner-software-v100-fda-510k.jpg K233616 - Clevaligner Software (V1.0.0) K233616 is a FDA 510(k) cleared dental medical device. Manufacturer: Clevaligner, Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k233664/ 2024-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k233664-ipl-hair-removal-device-ui06-pn-ui06-fda-510k.jpg K233664 - IPL Hair Removal Device (UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD,UI06 WH, UI06 MG, UI06 OB, UI06 LY,UI06 IG,) K233664 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Ulike Smart Electronics Co., Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k233712/ 2024-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k233712-prima-humeral-system-fda-510k.jpg K233712 - PRIMA Humeral System K233712 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Lima Corporate S.P.A.. Cleared Jan 2024. https://www.510kdatabase.net/k233945/ 2024-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k233945-proxidiagnost-n90-precision-crf-706110-fda-510k.jpg K233945 - ProxiDiagnost N90 / Precision CRF (706110, 706400) K233945 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Dmc GmbH. Cleared Jan 2024. https://www.510kdatabase.net/den220066/ 2024-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/den220066-brainsee-fda-510k.jpg DEN220066 - BrainSee DEN220066 is a FDA 510(k) cleared neurology medical device. Manufacturer: Darmiyan, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k232604/ 2024-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k232604-lyher-urine-marijuana-thc-test-kit-fda-510k.jpg K232604 - LYHER® Urine Marijuana (THC) Test Kit (Strip), LYHER® Urine Marijuana (THC) Test Kit (Cassette) K232604 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Hangzhou Laihe Biotech Co., Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k232955/ 2024-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k232955-numen-coil-embolization-system-fda-510k.jpg K232955 - Numen Coil Embolization System K232955 is a FDA 510(k) cleared neurology medical device. Manufacturer: MicroPort NeuroTech (Shanghai) Co., Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k233364/ 2024-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k233364-axon-therapy-fda-510k.jpg K233364 - Axon Therapy K233364 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Neuralace Medical, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k233902/ 2024-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k233902-centurion-vision-system-active-sentry-fda-510k.jpg K233902 - Centurion™ Vision System (Active Sentry™) (8065753057) K233902 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Alcon Laboratories, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k233903/ 2024-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k233903-zeta-cranial-navigation-system-zns131-us-fda-510k.jpg K233903 - Zeta Cranial Navigation System (ZNS131-US) K233903 is a FDA 510(k) cleared neurology medical device. Manufacturer: Zeta Surgical, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k233944/ 2024-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k233944-carboclear-x-pedicle-screw-system-fda-510k.jpg K233944 - CarboClear® X Pedicle Screw System K233944 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: CarboFix Orthopedics , Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k232312/ 2024-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k232312-gore-propaten-vascular-graft-fda-510k.jpg K232312 - GORE® PROPATEN® Vascular Graft K232312 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k232597/ 2024-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k232597-lyher-urine-multi-drug-test-kitcup-fda-510k.jpg K232597 - LYHER® Urine Multi-Drug Test Kit(Cup), LYHER® Urine Multi-Drug Test Kit(Cassette), LYHER® Urine Multi-Drug Test Kit(Dipcard) K232597 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Hangzhou Laihe Biotech Co., Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k232710/ 2024-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k232710-dental-cone-beam-computed-tomography-fda-510k.jpg K232710 - Dental Cone-beam Computed Tomography K232710 is a FDA 510(k) cleared radiology medical device. Manufacturer: Yian Medical Technology (Haining) Co., Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k233327/ 2024-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k233327-1788-4k-camera-system-with-advanced-fda-510k.jpg K233327 - 1788 4K Camera System with Advanced Imaging Modality K233327 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker Endoscopy. Cleared Jan 2024. https://www.510kdatabase.net/k231324/ 2024-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k231324-dasi-dimensions-v10-fda-510k.jpg K231324 - DASI Dimensions (V1.0) K231324 is a FDA 510(k) cleared radiology medical device. Manufacturer: Dasi Simulations. Cleared Jan 2024. https://www.510kdatabase.net/k232106/ 2024-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k232106-air-gap-fiber-fda-510k.jpg K232106 - Air Gap Fiber K232106 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wontech Co., Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k232412/ 2024-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k232412-lungq-v300-fda-510k.jpg K232412 - LungQ v3.0.0 K232412 is a FDA 510(k) cleared radiology medical device. Manufacturer: Thirona BV. Cleared Jan 2024. https://www.510kdatabase.net/k232894/ 2024-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k232894-halyard-fluidshield-2-surgical-mask-fda-510k.jpg K232894 - HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining (39123), HALYARD* FLUIDSHIELD* 2 Surgical Mask with Expanded Chamber with SO SOFT* Lining and Visor (39124) K232894 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Owens & Minor (O&M) Halyard, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k233035/ 2024-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k233035-electronic-muscle-stimulator-model-mp01-fda-510k.jpg K233035 - Electronic Muscle Stimulator (Model MP01) K233035 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Hengbosi Industrial Co., Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k233444/ 2024-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k233444-inkspace-imaging-small-body-array-fda-510k.jpg K233444 - InkSpace Imaging Small Body Array K233444 is a FDA 510(k) cleared radiology medical device. Manufacturer: Inkspace Imaging, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k233615/ 2024-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k233615-electrosurgical-pads-gbs-dm-1030ac-gbs-fda-510k.jpg K233615 - Electrosurgical Pads (GBS-Dm 1030ac, GBS-Db 1031ac, GBS-Dm 1030a, GBS-Db 1031a, GBS-Dm 1130ac, GBS-Db 1131ac, GBS-Dm 1130a, GBS-Db 1131a, GBS-Dm 1040ac, GBS-Db 1041ac, GBS-Dm 1040a, GBS-Db 1041a, GBS-Dm 1140ac, GBS-Db 1141ac, GBS-Dm 1140a, GBS-Db 1141a, GBS-Db 4030c, GBS-Db 4030, GBS-Db 4040c, GBS-Db 4040, GBS-Dm 1030bc, GBS-Db 1031bc, GBS-Dm 1030b, GBS-Db 1031b, GBS-Dm 1130bc, GBS-Db 1131bc, GBS-Dm 1130b, GBS-Db 1131b, GBS-Dm 1030nc, GBS-Db 1031nc, GBS-Dm 1030n, GBS-Db 1031n, GBS-Dm 1 K233615 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Baisheng Medical Co., Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k231068/ 2024-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k231068-autoscore-fda-510k.jpg K231068 - autoSCORE K231068 is a FDA 510(k) cleared neurology medical device. Manufacturer: Holberg Eeg AS. Cleared Jan 2024. https://www.510kdatabase.net/k231608/ 2024-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k231608-teleport-xt-microcatheter-fda-510k.jpg K231608 - Teleport XT Microcatheter K231608 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: OrbusNeich Medical (Shenzhen) Co., Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k232721/ 2024-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k232721-lifetech-cardio-temporary-pacemaker-fda-510k.jpg K232721 - Lifetech Cardio Temporary Pacemaker K232721 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k221766/ 2024-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k221766-solon-fda-510k.jpg K221766 - Solon K221766 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lmg Lasers Comercio, Importacao E Exportacao Ltda. Cleared Jan 2024. https://www.510kdatabase.net/k231163/ 2024-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k231163-hs-fiber-sutures-fda-510k.jpg K231163 - HS Fiber Sutures K231163 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Riverpoint Medical. Cleared Jan 2024. https://www.510kdatabase.net/k231263/ 2024-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k231263-fusion-core-dc-flo-fda-510k.jpg K231263 - Fusion Core DC Flo K231263 is a FDA 510(k) cleared dental medical device. Manufacturer: Prevest Denpro Limited. Cleared Jan 2024. https://www.510kdatabase.net/k231273/ 2024-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k231273-archerqa-v10-fda-510k.jpg K231273 - ArcherQA (V1.0) K231273 is a FDA 510(k) cleared radiology medical device. Manufacturer: Wisdom Technologies., Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k231917/ 2024-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k231917-vea-align-fda-510k.jpg K231917 - VEA Align K231917 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eos Imaging. Cleared Jan 2024. https://www.510kdatabase.net/k232519/ 2024-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k232519-endocollect-specimen-retrieval-bag-fda-510k.jpg K232519 - ENDOCOLLECT Specimen Retrieval Bag K232519 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ximedica. Cleared Jan 2024. https://www.510kdatabase.net/k233229/ 2024-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k233229-navicam-small-bowel-capsule-endoscopy-fda-510k.jpg K233229 - NaviCam Small Bowel Capsule Endoscopy System with NaviCam SB Capsule and NaviCam Tether K233229 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Anx Robotica Corporation. Cleared Jan 2024. https://www.510kdatabase.net/k233316/ 2024-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k233316-dess-dental-smart-solutions-fda-510k.jpg K233316 - DESS Dental Smart Solutions K233316 is a FDA 510(k) cleared dental medical device. Manufacturer: Terrats Medical SL. Cleared Jan 2024. https://www.510kdatabase.net/k233679/ 2024-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k233679-ipl-hair-removal-device-ui04-mkui04-fda-510k.jpg K233679 - IPL Hair Removal Device (UI04 MK,UI04 BN,UI04 BU,UI04 CB,UI04 GY,UI04 LG,UI04 DG,UI04 PL,UI04 PN,UI04 SD,UI04 SG,UI04 MG) K233679 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Ulike Smart Electronics Co., Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k221110/ 2024-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k221110-luofucon-silver-gelling-fiber-surgical-fda-510k.jpg K221110 - LUOFUCON Silver Gelling Fiber Surgical Dressing, LUOFUCON Antibacterial Gelling Fiber Cover Dressing K221110 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Huizhou Foryou Medical Devices Co., Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k223228/ 2024-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k223228-dayspring-fda-510k.jpg K223228 - Dayspring K223228 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Koya Medical, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k230277/ 2024-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k230277-pulse-oximetermodel-oht60oxh78-fda-510k.jpg K230277 - Pulse Oximeter(Model OHT60,OXH78) K230277 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Cofoe Medical Technology Co., Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k230507/ 2024-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k230507-zimed-distal-medial-tibial-plate-and-fda-510k.jpg K230507 - Zimed Distal Medial Tibial Plate and Screw System K230507 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimed Medikal. Cleared Jan 2024. https://www.510kdatabase.net/k230996/ 2024-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k230996-pursuant-health-kiosk-g1d5-fda-510k.jpg K230996 - Pursuant Health Kiosk (G1.D5) K230996 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Pursuant Health. Cleared Jan 2024. https://www.510kdatabase.net/k231033/ 2024-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k231033-ceptre-knotted-uhmwpe-suture-peek-anchor-fda-510k.jpg K231033 - CEPTRE® Knotted UHMWPE Suture PEEK Anchor K231033 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Healthium Medtech Limited. Cleared Jan 2024. https://www.510kdatabase.net/k231058/ 2024-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k231058-hudson-rci-addipak-unit-dose-vial-fda-510k.jpg K231058 - Hudson RCI® AddiPak® Unit Dose Vial K231058 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Medline Industries, LP. Cleared Jan 2024. https://www.510kdatabase.net/k231072/ 2024-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k231072-anthogyr-flexibase-titanium-bases-for-fda-510k.jpg K231072 - Anthogyr FlexiBase® titanium bases for Axiom® BL K231072 is a FDA 510(k) cleared dental medical device. Manufacturer: Anthogyr. Cleared Jan 2024. https://www.510kdatabase.net/k232136/ 2024-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k232136-syngoct-applications-fda-510k.jpg K232136 - syngo.CT Applications K232136 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k232330/ 2024-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k232330-lancing-system-fda-510k.jpg K232330 - Lancing System K232330 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ningbo Medsun Medical Co., Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k232808/ 2024-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k232808-butterfly-iq3-ultrasound-system-fda-510k.jpg K232808 - Butterfly iQ3 Ultrasound System K232808 is a FDA 510(k) cleared radiology medical device. Manufacturer: Butterfly Network, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k233556/ 2024-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k233556-led-eye-mask-ey-20r-a20-ey-20n-fda-510k.jpg K233556 - LED Eye mask (EY-20R, A20, EY-20N) K233556 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Kaiyan Medical Equipment Co., Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k233671/ 2024-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k233671-ambu-ascope-5-broncho-4222-fda-510k.jpg K233671 - Ambu® aScope™ 5 Broncho 4.2/2.2 K233671 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Ambu A/S. Cleared Jan 2024. https://www.510kdatabase.net/k223397/ 2024-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k223397-hoya-illumina-sorafilcon-a-daily-fda-510k.jpg K223397 - HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact Lens K223397 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Hoya Lamphun , Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k231256/ 2024-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k231256-carecube-negative-pressure-isolation-fda-510k.jpg K231256 - Carecube Negative Pressure Isolation Chamber K231256 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Carecubes, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k231707/ 2024-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k231707-resq-administration-set-fda-510k.jpg K231707 - ResQ Administration Set K231707 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Q For Plastic Industries. Cleared Jan 2024. https://www.510kdatabase.net/k231779/ 2024-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k231779-remi-ai-discrete-detection-module-fda-510k.jpg K231779 - REMI AI Discrete Detection Module K231779 is a FDA 510(k) cleared neurology medical device. Manufacturer: Epitel, Inc.. Cleared Jan 2024. https://www.510kdatabase.net/k232589/ 2024-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k232589-horos-md-fda-510k.jpg K232589 - Horos MD™ K232589 is a FDA 510(k) cleared radiology medical device. Manufacturer: Icat Solutions, Ltd.. Cleared Jan 2024. https://www.510kdatabase.net/k233395/ 2024-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k233395-portable-dental-x-ray-axr60-s-fda-510k.jpg K233395 - Portable Dental X-Ray (AXR60 S) K233395 is a FDA 510(k) cleared radiology medical device. Manufacturer: Alliage S/A Industrias M?dico Odontol?gica. Cleared Jan 2024. https://www.510kdatabase.net/k233550/ 2024-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k233550-mosaic-3d-surgical-laser-fda-510k.jpg K233550 - MOSAIC 3D (Surgical Laser) K233550 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lutronic Aesthetic. Cleared Jan 2024. https://www.510kdatabase.net/k223714/ 2023-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k223714-unifit-dental-implant-system-fda-510k.jpg K223714 - UniFit Dental Implant System K223714 is a FDA 510(k) cleared dental medical device. Manufacturer: Adin Dental Implant Systems , Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k230438/ 2023-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k230438-uris-smart-path-implant-system-fda-510k.jpg K230438 - URIS Smart Path Implant System & Prosthetic K230438 is a FDA 510(k) cleared dental medical device. Manufacturer: Truabutment, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k230986/ 2023-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k230986-bladder-scanner-fda-510k.jpg K230986 - Bladder Scanner K230986 is a FDA 510(k) cleared radiology medical device. Manufacturer: Avantsonic Technology Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k232688/ 2023-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k232688-nq-tms-for-mdd-nqv1-mu-01-fda-510k.jpg K232688 - NQ TMS for MDD (NQv1-MU-01) K232688 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neuroqore, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k233362/ 2023-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k233362-flyte-mechanotherapy-system-aka-flyte-fda-510k.jpg K233362 - Flyte Mechanotherapy System (aka Flyte System) (MTI-1.0) K233362 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Pelvital USA, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k233790/ 2023-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k233790-acl-top-970-cl-fda-510k.jpg K233790 - ACL TOP 970 CL K233790 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory. Cleared Dec 2023. https://www.510kdatabase.net/k233856/ 2023-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k233856-precision1-fda-510k.jpg K233856 - Precision1 K233856 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Alcon Laboratories, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k230006/ 2023-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k230006-ankyras-fda-510k.jpg K230006 - Ankyras K230006 is a FDA 510(k) cleared neurology medical device. Manufacturer: Mentice Spain S.L.. Cleared Dec 2023. https://www.510kdatabase.net/k230891/ 2023-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k230891-surestitch-uhmwpe-suture-peek-button-fda-510k.jpg K230891 - SURESTITCH™ UHMWPE Suture PEEK Button Meniscus Repair Implant K230891 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Healthium Medtech Limited. Cleared Dec 2023. https://www.510kdatabase.net/k230985/ 2023-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k230985-planmeca-viso-fda-510k.jpg K230985 - Planmeca Viso K230985 is a FDA 510(k) cleared radiology medical device. Manufacturer: Planmeca Oy. Cleared Dec 2023. https://www.510kdatabase.net/k230997/ 2023-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k230997-evowalk-10-system-fda-510k.jpg K230997 - EvoWalk 1.0 System K230997 is a FDA 510(k) cleared neurology medical device. Manufacturer: Evolution Devices, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k231055/ 2023-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k231055-x-mind-dc-under-trademark-acteon-fda-510k.jpg K231055 - x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology) K231055 is a FDA 510(k) cleared radiology medical device. Manufacturer: De G?tzen S.R.L.. Cleared Dec 2023. https://www.510kdatabase.net/k233405/ 2023-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k233405-blue-powder-free-nitrile-examination-fda-510k.jpg K233405 - Blue Powder Free Nitrile Examination Glove with Chemotherapy Drugs and Fentanyl Test Claim K233405 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Eco Medi Glove Sdn. Bhd.. Cleared Dec 2023. https://www.510kdatabase.net/k231084/ 2023-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k231084-tearcare-mgx-system-fda-510k.jpg K231084 - TearCare MGX System K231084 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Sight Sciences, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k231914/ 2023-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k231914-nurochek-ii-system-fda-510k.jpg K231914 - Nurochek-II System K231914 is a FDA 510(k) cleared neurology medical device. Manufacturer: Headsafe Mfg Pty, Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k232518/ 2023-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k232518-endosound-vision-system-fda-510k.jpg K232518 - EndoSound Vision System K232518 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Endosound, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k232756/ 2023-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k232756-colibr-fda-510k.jpg K232756 - Colibrí K232756 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Copan Wasp Srl. Cleared Dec 2023. https://www.510kdatabase.net/k233858/ 2023-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k233858-trisalus-triguidetm-guiding-catheter-fda-510k.jpg K233858 - TriSalus TriGuideTM Guiding Catheter K233858 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Trisalus Life Sciences. Cleared Dec 2023. https://www.510kdatabase.net/k231130/ 2023-12-26 monthly 0.5 https://www.510kdatabase.net/og-image/k231130-tumorsight-viz-fda-510k.jpg K231130 - TumorSight Viz K231130 is a FDA 510(k) cleared radiology medical device. Manufacturer: SimBioSys, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k232937/ 2023-12-26 monthly 0.5 https://www.510kdatabase.net/og-image/k232937-btl-899m-fda-510k.jpg K232937 - BTL-899M K232937 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: BTL Industries, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k233300/ 2023-12-26 monthly 0.5 https://www.510kdatabase.net/og-image/k233300-poweream-14-drive-fda-510k.jpg K233300 - POWEReam 1/4 Drive K233300 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Instruments. Cleared Dec 2023. https://www.510kdatabase.net/k233515/ 2023-12-26 monthly 0.5 https://www.510kdatabase.net/og-image/k233515-dual-lumen-extended-length-catheter-fda-510k.jpg K233515 - Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102) K233515 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Nuwellis, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k233659/ 2023-12-26 monthly 0.5 https://www.510kdatabase.net/og-image/k233659-suture-wing-fda-510k.jpg K233659 - Suture Wing K233659 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonic Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k223745/ 2023-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k223745-novae-dual-mobility-system-hype-hip-fda-510k.jpg K223745 - Novae® Dual Mobility System, Hype® Hip System K223745 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Serf. Cleared Dec 2023. https://www.510kdatabase.net/k230267/ 2023-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k230267-neumodx-ctng-assay-20-fda-510k.jpg K230267 - NeuMoDx CT/NG Assay 2.0 K230267 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Neumodx Molecular, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k230439/ 2023-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k230439-wellcare-anoscope-fda-510k.jpg K230439 - WellCare Anoscope K230439 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Well Care (Wuhan) Medical Technology Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k231086/ 2023-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k231086-cpm-system-fda-510k.jpg K231086 - CPM System K231086 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Analog Devices, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k231794/ 2023-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k231794-elegant-advanced-comphort-fda-510k.jpg K231794 - Elegant™ Advanced CompHort K231794 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Viramal Limited. Cleared Dec 2023. https://www.510kdatabase.net/k231805/ 2023-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k231805-qxr-ln-fda-510k.jpg K231805 - qXR-LN K231805 is a FDA 510(k) cleared radiology medical device. Manufacturer: Qure.Ai Technologies. Cleared Dec 2023. https://www.510kdatabase.net/k232293/ 2023-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k232293-kallisio-stentra-oral-stent-fda-510k.jpg K232293 - kallisio stentra™ oral stent K232293 is a FDA 510(k) cleared radiology medical device. Manufacturer: Kallisio, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k232300/ 2023-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k232300-elastimed-sacs-fda-510k.jpg K232300 - ElastiMed SACS K232300 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Elastimed , Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k232338/ 2023-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k232338-electronic-thermometer-model-aet-f331-fda-510k.jpg K232338 - Electronic Thermometer, Model: AET-F331, AET-F332, AET-F333, AET-F344, AET-F345, AET-F346, AET-F354, AET-F355, AET-F356, AET-F361, AET-F362, AET-F363, AET-F371, AET-F372, AET-F373, AET-F381, AET-F382, AET-F383 K232338 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Alicn Medical (Shenzhen), Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k232479/ 2023-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k232479-art-plan-fda-510k.jpg K232479 - ART-Plan K232479 is a FDA 510(k) cleared radiology medical device. Manufacturer: Therapanacea. Cleared Dec 2023. https://www.510kdatabase.net/k232535/ 2023-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k232535-magnetom-sola-fda-510k.jpg K232535 - MAGNETOM Sola K232535 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k232717/ 2023-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k232717-apex-locator-al-pex-apex-locator-al-pex-fda-510k.jpg K232717 - Apex Locator (AL-Pex), Apex Locator (AL-Pex+) K232717 is a FDA 510(k) cleared dental medical device. Manufacturer: Changzhou Haili Medical Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k232789/ 2023-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k232789-vio-system-v-1000-fda-510k.jpg K232789 - VIO System (V-1000) K232789 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Enspectra Health, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k232881/ 2023-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k232881-winged-infusion-set-safety-winged-fda-510k.jpg K232881 - Winged Infusion Set, Safety Winged Infusion Set, Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Needle Holder K232881 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Kangbao Medical Equipment Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k233027/ 2023-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k233027-nanozoomer-s360md-slide-scanner-system-fda-510k.jpg K233027 - NanoZoomer S360MD Slide scanner system K233027 is a FDA 510(k) cleared pathology medical device. Manufacturer: Hamamatsu Photonics K.K.. Cleared Dec 2023. https://www.510kdatabase.net/k233058/ 2023-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k233058-vivachek-link-plus-blood-glucose-fda-510k.jpg K233058 - VivaChek Link Plus Blood Glucose Monitoring System K233058 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Vivachek Biotech (Hangzhou) Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k233082/ 2023-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k233082-topcem-dual-cure-resin-cement-fda-510k.jpg K233082 - TopCEM Dual Cure Resin Cement K233082 is a FDA 510(k) cleared dental medical device. Manufacturer: Rizhao Huge Biomaterials Company, Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k233104/ 2023-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k233104-sofwave-system-fda-510k.jpg K233104 - SofWave System K233104 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sofwave Medical, Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k233109/ 2023-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k233109-tp-pivot-pro-needle-guide-fda-510k.jpg K233109 - TP Pivot Pro™ Needle Guide K233109 is a FDA 510(k) cleared radiology medical device. Manufacturer: Civco Medical Solutions. Cleared Dec 2023. https://www.510kdatabase.net/k233205/ 2023-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k233205-distal-access-catheter-fda-510k.jpg K233205 - Distal Access Catheter K233205 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shanghai Heartcare Medical Technology Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k233264/ 2023-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k233264-anthogyr-integral-guided-surgery-fda-510k.jpg K233264 - Anthogyr INTEGRAL Guided Surgery Cassettes K233264 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Anthogyr. Cleared Dec 2023. https://www.510kdatabase.net/k233304/ 2023-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k233304-omnimax-s3-omnimax-s4-fda-510k.jpg K233304 - Omnimax S3, Omnimax S4 K233304 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sharplight Technologies, Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k233734/ 2023-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k233734-interson-usb-ultrasound-system-fda-510k.jpg K233734 - Interson USB Ultrasound System K233734 is a FDA 510(k) cleared radiology medical device. Manufacturer: Interson Corporation. Cleared Dec 2023. https://www.510kdatabase.net/k233742/ 2023-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k233742-cloudtms-edge-for-ocd-fda-510k.jpg K233742 - CloudTMS Edge for OCD K233742 is a FDA 510(k) cleared neurology medical device. Manufacturer: Teleemg, LLC. Cleared Dec 2023. https://www.510kdatabase.net/k234043/ 2023-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k234043-3m-transbond-orthodontic-adhesive-fda-510k.jpg K234043 - 3M™ Transbond™ Orthodontic Adhesive K234043 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Unitek Orthodontic Products. Cleared Dec 2023. https://www.510kdatabase.net/den230020/ 2023-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/den230020-biotraceio-lite-fda-510k.jpg DEN230020 - BioTraceIO Lite DEN230020 is a FDA 510(k) cleared radiology medical device. Manufacturer: Techsomed Medical Technologies , Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k221753/ 2023-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k221753-kangbeier-child-surgical-mask-fda-510k.jpg K221753 - Kangbeier Child Surgical Mask K221753 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Xinxiang Kangbeier Medical Technology Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k223359/ 2023-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k223359-luofucon-ag-foam-dressing-luofucon-ag-fda-510k.jpg K223359 - LUOFUCON® Ag+ Foam Dressing, LUOFUCON® Ag+ Antibacterial Foam Dressing K223359 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Huizhou Foryou Medical Devices Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k223729/ 2023-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k223729-flowpresso-fda-510k.jpg K223729 - FLOWpresso K223729 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Medella Health Limited. Cleared Dec 2023. https://www.510kdatabase.net/k230887/ 2023-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k230887-sysmex-xq-series-xq-320-automated-fda-510k.jpg K230887 - Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer K230887 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sysmex America, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k231027/ 2023-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k231027-kaibili-extended-viraltrans-fda-510k.jpg K231027 - KaiBiLi Extended ViralTrans K231027 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Hangzhou Genesis Biodetection & Biocontrol Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k231099/ 2023-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k231099-smr-hybrid-glenoid-system-fda-510k.jpg K231099 - SMR Hybrid Glenoid System K231099 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Lima Corporate S.P.A.. Cleared Dec 2023. https://www.510kdatabase.net/k231307/ 2023-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k231307-elos-accurate-customized-abutment-fda-510k.jpg K231307 - Elos Accurate Customized Abutment K231307 is a FDA 510(k) cleared dental medical device. Manufacturer: Elos Medtech Pinol A/S. Cleared Dec 2023. https://www.510kdatabase.net/k231531/ 2023-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k231531-pediarity-fda-510k.jpg K231531 - Pediarity™ K231531 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Hinlab, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k231889/ 2023-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k231889-endoscopic-ultrasonic-diagnostic-fda-510k.jpg K231889 - Endoscopic Ultrasonic Diagnostic Equipment /Disposable Sterile Endoscopic Ultrasonic Probe (USW-S1,USW140-S20MS) K231889 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ultrasound Biotechnology (Shanghai) Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k232320/ 2023-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k232320-isrobot-mona-lisa-20-fda-510k.jpg K232320 - iSR`obot Mona Lisa 2.0 K232320 is a FDA 510(k) cleared radiology medical device. Manufacturer: Biobot Surgical Pte., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k232329/ 2023-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k232329-defendo-fujifilm-700-single-use-biopsy-fda-510k.jpg K232329 - Defendo Fujifilm 700 Single Use Biopsy Valve K232329 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medivators (A Subsidiary of Steris Corporation). Cleared Dec 2023. https://www.510kdatabase.net/k232579/ 2023-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k232579-twoplus-applicator-fda-510k.jpg K232579 - Twoplus Applicator K232579 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Hannah Life Technologies Pte , Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k232744/ 2023-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k232744-syngo-virtual-cockpit-vb10a-fda-510k.jpg K232744 - syngo Virtual Cockpit (VB10A) K232744 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Healthcare GmbH. Cleared Dec 2023. https://www.510kdatabase.net/k232784/ 2023-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k232784-relizorb-fda-510k.jpg K232784 - RELiZORB® K232784 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Alcresta Therapeutics, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k232870/ 2023-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k232870-truebeam-truebeam-stx-edge-and-fda-510k.jpg K232870 - TrueBeam, TrueBeam STx, EDGE and VitalBeam (4.1) K232870 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k232888/ 2023-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k232888-disposable-laryngeal-electrodes-fda-510k.jpg K232888 - Disposable Laryngeal Electrodes K232888 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Suzhou Haishen Medical Device Associates Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k232944/ 2023-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k232944-callisto-eye-fda-510k.jpg K232944 - CALLISTO eye K232944 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Carl Zeiss Meditec, AG. Cleared Dec 2023. https://www.510kdatabase.net/k233016/ 2023-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k233016-dental-glass-ceramics-fda-510k.jpg K233016 - Dental Glass Ceramics K233016 is a FDA 510(k) cleared dental medical device. Manufacturer: Shenzhen Yurucheng Dental Materials Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k233018/ 2023-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k233018-picosecond-ndyag-laser-system-fda-510k.jpg K233018 - PICOSECOND Nd:YAG Laser System K233018 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ids, Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k233112/ 2023-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k233112-hm70-evo-diagnostic-ultrasound-system-fda-510k.jpg K233112 - HM70 EVO Diagnostic Ultrasound System K233112 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Medison Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k233154/ 2023-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k233154-skyops-orthopedic-plate-system-fda-510k.jpg K233154 - SkyOPS™ Orthopedic Plate System K233154 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Sky Surgical, LLC. Cleared Dec 2023. https://www.510kdatabase.net/k233276/ 2023-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k233276-reusable-blood-pressure-cuff-fda-510k.jpg K233276 - Reusable Blood Pressure Cuff K233276 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Suzhou Minhua Medical Apparatus Supplies Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k233396/ 2023-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k233396-cannulated-screw-system-fda-510k.jpg K233396 - Cannulated Screw System K233396 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k233423/ 2023-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k233423-tyber-medical-anatomical-plating-fda-510k.jpg K233423 - Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag System K233423 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tyber Medical, LLC. Cleared Dec 2023. https://www.510kdatabase.net/k233465/ 2023-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k233465-radiforce-mx317w-fda-510k.jpg K233465 - RadiForce MX317W K233465 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eizo Corporation. Cleared Dec 2023. https://www.510kdatabase.net/k233498/ 2023-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k233498-stryker-orthopaedics-hip-systems-fda-510k.jpg K233498 - Stryker Orthopaedics Hip Systems Labeling Update K233498 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp., Dba Stryker Orthopaedics. Cleared Dec 2023. https://www.510kdatabase.net/k233741/ 2023-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k233741-hoffmann-lrf-system-fda-510k.jpg K233741 - Hoffmann LRF System K233741 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker GmbH. Cleared Dec 2023. https://www.510kdatabase.net/k233813/ 2023-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k233813-bearing-nspva-express-fda-510k.jpg K233813 - Bearing nsPVA Express™ K233813 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k233848/ 2023-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k233848-sonata-transcervical-fibroid-ablation-fda-510k.jpg K233848 - Sonata Transcervical Fibroid Ablation System 2.2 (SONATA2-220) K233848 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Gynesonics, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k223585/ 2023-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k223585-pure-plus-uv-aspheric-otufilcon-a-fda-510k.jpg K223585 - Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear K223585 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Yung Sheng Optical Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k230545/ 2023-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k230545-inessa-system-fda-510k.jpg K230545 - Inessa System K230545 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Triple Jump Israel , Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k230736/ 2023-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k230736-magnetos-putty-fda-510k.jpg K230736 - MagnetOs Putty K230736 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Kuros Biosciences B.V. Cleared Dec 2023. https://www.510kdatabase.net/k230850/ 2023-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k230850-united-orthopedic-knee-patient-fda-510k.jpg K230850 - United Orthopedic Knee Patient Specific Instrumentation K230850 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Enhatch, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k230855/ 2023-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k230855-bd-vacutainer-serum-separator-sst-fda-510k.jpg K230855 - BD Vacutainer® Serum Separator (SST™) Blood Collection Tubes K230855 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Becton, Dickinson and Company. Cleared Dec 2023. https://www.510kdatabase.net/k230955/ 2023-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k230955-syngo-application-software-fda-510k.jpg K230955 - syngo Application Software K230955 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k231227/ 2023-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k231227-sureflex-hd-steerable-sheath-fda-510k.jpg K231227 - SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath K231227 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baylis Medical Company, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k231354/ 2023-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k231354-pocket-ultrasound-system-c10-fda-510k.jpg K231354 - Pocket Ultrasound System (C10) K231354 is a FDA 510(k) cleared radiology medical device. Manufacturer: Beijing Konted Medical Technology Co.,Ltd. Cleared Dec 2023. https://www.510kdatabase.net/k231402/ 2023-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k231402-hp-pta-balloon-dilatation-catheter-fda-510k.jpg K231402 - HP PTA Balloon Dilatation Catheter K231402 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Kossel Medtech (Suzhou) Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k231411/ 2023-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k231411-inno-sla-submerged-hybrid-ti-base-system-fda-510k.jpg K231411 - INNO SLA Submerged Hybrid Ti-Base System K231411 is a FDA 510(k) cleared dental medical device. Manufacturer: Cowellmedi Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k231556/ 2023-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k231556-spectrum-gv-bone-cement-fda-510k.jpg K231556 - SPECTRUM® GV Bone Cement K231556 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteoremedies, LLC. Cleared Dec 2023. https://www.510kdatabase.net/k231660/ 2023-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k231660-digital-image-scanner-of-dental-fda-510k.jpg K231660 - Digital image scanner of dental K231660 is a FDA 510(k) cleared radiology medical device. Manufacturer: Jiangsu Dynamic Medical Technology Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k231780/ 2023-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k231780-perifit-care-fda-510k.jpg K231780 - Perifit Care+ K231780 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: X6 Innovations. Cleared Dec 2023. https://www.510kdatabase.net/k231968/ 2023-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k231968-tactoset-injectable-bone-substitute-fda-510k.jpg K231968 - Tactoset® Injectable Bone Substitute K231968 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Anika Therapeutics, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k232017/ 2023-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k232017-ark-methotrexate-ii-assay-fda-510k.jpg K232017 - ARK Methotrexate II Assay K232017 is a FDA 510(k) cleared toxicology medical device. Manufacturer: ARK Diagnostics, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k232048/ 2023-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k232048-cogent-hemodynamic-monitoring-system-fda-510k.jpg K232048 - Cogent™ Hemodynamic Monitoring System K232048 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Icu Medical. Cleared Dec 2023. https://www.510kdatabase.net/k232286/ 2023-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k232286-savanna-hsv-12vzv-assay-savanna-hsv-fda-510k.jpg K232286 - Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument K232286 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Quidel Corporation. Cleared Dec 2023. https://www.510kdatabase.net/k232444/ 2023-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k232444-sterile-powder-free-latex-surgical-fda-510k.jpg K232444 - Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs K232444 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Grand Work Plastic Products Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k232736/ 2023-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k232736-chemtrue-drug-screen-fentanyltramadol-fda-510k.jpg K232736 - Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen Fentanyl/Tramadol Dip Card Test, Chemtrue® Multi-Panel Drug Screen Cup Test, Chemtrue® Multi-Panel Drug Screen Dip Card Test K232736 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Chemtron Biotech, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k232992/ 2023-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k232992-10therma-fda-510k.jpg K232992 - 10THERMA K232992 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Tentech, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k233017/ 2023-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k233017-tm-plating-system-fda-510k.jpg K233017 - TM Plating System K233017 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tyber Medical, LLC. Cleared Dec 2023. https://www.510kdatabase.net/k233130/ 2023-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k233130-blood-pressure-monitor-fda-510k.jpg K233130 - Blood Pressure Monitor K233130 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Guangdong Transtek Medical Electronics Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k233176/ 2023-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k233176-uomnispacemi-fda-510k.jpg K233176 - uOmnispace.MI K233176 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k233492/ 2023-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k233492-ems-neck-massager-fda-510k.jpg K233492 - EMS Neck Massager K233492 is a FDA 510(k) cleared neurology medical device. Manufacturer: Xiamen Comfier Technology Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k233782/ 2023-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k233782-smoothskin-pure-adapt-ssg3-fda-510k.jpg K233782 - SmoothSkin Pure Adapt (SSG3) K233782 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cyden Limited. Cleared Dec 2023. https://www.510kdatabase.net/k233839/ 2023-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k233839-peridot-pt-anterior-cervical-fda-510k.jpg K233839 - Peridot-PT Anterior Cervical Intervertebral body fusion System K233839 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Gbs Commonwealth Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k221199/ 2023-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k221199-conductive-silicone-electrode-model-fda-510k.jpg K221199 - Conductive Silicone Electrode (model: Foot Pad Electrode, Cupping Electrode, Point Electrode) K221199 is a FDA 510(k) cleared neurology medical device. Manufacturer: Green Island International Tcm Group Limited. Cleared Dec 2023. https://www.510kdatabase.net/k222810/ 2023-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k222810-td-7301-peak-flow-meter-fda-510k.jpg K222810 - TD-7301 Peak Flow meter K222810 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Gostar Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k230840/ 2023-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k230840-pmt-facet-fixation-system-lumbar-pmt-fda-510k.jpg K230840 - PMT Facet Fixation System, Lumbar (PMT FFS-LX) K230840 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Providence Medical Technology, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k231526/ 2023-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k231526-corail-cemented-femoral-stem-fda-510k.jpg K231526 - CORAIL Cemented Femoral Stem K231526 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Ireland UC. Cleared Dec 2023. https://www.510kdatabase.net/k231671/ 2023-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k231671-intellivue-patient-monitor-mx750-fda-510k.jpg K231671 - IntelliVue Patient Monitor MX750 (866471), IntelliVue Patient Monitor MX850 (866470), IntelliVue 4-Slot Module Rack FMX-4 (866468) K231671 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Philips Medizin Systeme Boeblingen GmbH. Cleared Dec 2023. https://www.510kdatabase.net/k232458/ 2023-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k232458-jetihydrodynamic-thrombectomy-system-fda-510k.jpg K232458 - JETi™Hydrodynamic Thrombectomy System K232458 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared Dec 2023. https://www.510kdatabase.net/k232560/ 2023-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k232560-angled-abutment-fda-510k.jpg K232560 - Angled Abutment K232560 is a FDA 510(k) cleared dental medical device. Manufacturer: Arum Dentistry Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k233132/ 2023-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k233132-primus-healthcare-sterilizer-model-fda-510k.jpg K233132 - PRIMUS Healthcare Sterilizer (Model PSS11-HA & PSS11-HB) K233132 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Primus Sterilizer Company, LLC. Cleared Dec 2023. https://www.510kdatabase.net/k233163/ 2023-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k233163-zenex-implant-systemshort-fda-510k.jpg K233163 - ZENEX Implant System_Short K233163 is a FDA 510(k) cleared dental medical device. Manufacturer: Izenimplant Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k233448/ 2023-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k233448-bactiseal-evd-catheter-sets-fda-510k.jpg K233448 - Bactiseal EVD Catheter Sets K233448 is a FDA 510(k) cleared neurology medical device. Manufacturer: Integra Lifesciences Production Corporation. Cleared Dec 2023. https://www.510kdatabase.net/k233470/ 2023-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k233470-deka-lily-fda-510k.jpg K233470 - DEKA LILY K233470 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: El.En S.P.A.. Cleared Dec 2023. https://www.510kdatabase.net/k233551/ 2023-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k233551-gore-acuseal-vascular-graft-fda-510k.jpg K233551 - GORE® ACUSEAL Vascular Graft K233551 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k222846/ 2023-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k222846-amt-g-tube-balloon-gastrostomy-feeding-fda-510k.jpg K222846 - AMT G-Tube Balloon Gastrostomy Feeding Device K222846 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Applied Medical Technology, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k222881/ 2023-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k222881-access-hstni-fda-510k.jpg K222881 - Access hsTnI K222881 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k231066/ 2023-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k231066-curator-ex3242-fd-fda-510k.jpg K231066 - CuratOR EX3242-FD K231066 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Eizo Corporation. Cleared Dec 2023. https://www.510kdatabase.net/k231429/ 2023-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k231429-s-plant-dental-implant-system-fda-510k.jpg K231429 - S-Plant Dental Implant System K231429 is a FDA 510(k) cleared dental medical device. Manufacturer: Idis Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k231587/ 2023-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k231587-magnetom-cimax-fda-510k.jpg K231587 - MAGNETOM Cima.X K231587 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k231929/ 2023-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k231929-iq-solutions-fda-510k.jpg K231929 - iQ-solutions K231929 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sydney Neuroimaging Analysis Centre Pty, Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k232780/ 2023-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k232780-cc-clip-implant-system-fda-510k.jpg K232780 - CC-Clip® Implant System K232780 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Cc-Instruments, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k232847/ 2023-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k232847-sioxd-wound-matrix-fda-510k.jpg K232847 - SiOxD Wound Matrix K232847 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sioxmed, LLC. Cleared Dec 2023. https://www.510kdatabase.net/k232984/ 2023-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k232984-ion-endoluminal-system-if1000-fda-510k.jpg K232984 - Ion Endoluminal System (IF1000) K232984 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k233815/ 2023-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k233815-clottriever-sheath-fda-510k.jpg K233815 - ClotTriever Sheath K233815 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inari Medical, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k233691/ 2023-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k233691-flexcath-cross-transseptal-solution-fda-510k.jpg K233691 - FlexCath Cross Transseptal Solution K233691 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Acutus Medical, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k233536/ 2023-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k233536-air-compression-recovery-system-fda-510k.jpg K233536 - Air Compression Recovery System K233536 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Shenzhen Dongjilian Medical Tech Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k223721/ 2023-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k223721-masimo-stork-fda-510k.jpg K223721 - Masimo Stork K223721 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Masimo Corporation. Cleared Dec 2023. https://www.510kdatabase.net/k230501/ 2023-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k230501-spirobank-oxi-fda-510k.jpg K230501 - Spirobank Oxi K230501 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Mir Medical International Research USA. Cleared Dec 2023. https://www.510kdatabase.net/k230751/ 2023-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k230751-ew10-ec02-endoscopy-support-program-fda-510k.jpg K230751 - EW10-EC02 Endoscopy Support Program K230751 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fujifilm Corporation. Cleared Dec 2023. https://www.510kdatabase.net/k230926/ 2023-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k230926-ova-k-ovap-usa-fda-510k.jpg K230926 - Ova+ (K-OVAP-USA) K230926 is a FDA 510(k) cleared neurology medical device. Manufacturer: Tenscare, Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k230949/ 2023-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k230949-artis-pheno-ve30a-fda-510k.jpg K230949 - ARTIS pheno (VE30A) K230949 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k231160/ 2023-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k231160-cardio-q50-cardio-q70-fda-510k.jpg K231160 - Cardio Q50, Cardio Q70 K231160 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bionet Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k231447/ 2023-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k231447-double-internal-joint-stabilizer-elbow-fda-510k.jpg K231447 - Double Internal Joint Stabilizer- Elbow K231447 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Skeletal Dynamics, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k231478/ 2023-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k231478-digital-blood-pressure-monitor-model-fda-510k.jpg K231478 - Digital Blood Pressure Monitor (Model: YB-800) K231478 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Wenzhou Yosun Medical Technology Co.,Ltd. Cleared Dec 2023. https://www.510kdatabase.net/k231700/ 2023-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k231700-ziehm-vision-fd-fda-510k.jpg K231700 - Ziehm Vision FD K231700 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ziehm Imaging GmbH. Cleared Dec 2023. https://www.510kdatabase.net/k231825/ 2023-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k231825-panther-tps-fda-510k.jpg K231825 - Panther TPS K231825 is a FDA 510(k) cleared radiology medical device. Manufacturer: Prowess, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k232095/ 2023-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k232095-septicyte-rapid-fda-510k.jpg K232095 - SeptiCyte RAPID K232095 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Immunexpress, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k232130/ 2023-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k232130-medline-renewal-reprocessed-viewflex-fda-510k.jpg K232130 - Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter K232130 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Surgical Instrument Services and Savings, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k232267/ 2023-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k232267-precice-max-system-fda-510k.jpg K232267 - Precice Max System K232267 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nuvasive Specialized Orthopedics, Incorporated. Cleared Dec 2023. https://www.510kdatabase.net/k232384/ 2023-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k232384-videa-dental-assist-fda-510k.jpg K232384 - Videa Dental Assist K232384 is a FDA 510(k) cleared radiology medical device. Manufacturer: Videahealth, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k232394/ 2023-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k232394-internal-locking-plate-and-screw-fda-510k.jpg K232394 - Internal Locking Plate and Screw Fixation System K232394 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k232598/ 2023-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k232598-unscented-menstrual-tampon-fda-510k.jpg K232598 - Unscented Menstrual Tampon K232598 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Unibeauty (Hubei) Technology Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k232887/ 2023-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k232887-invisalign-palatal-expander-system-fda-510k.jpg K232887 - Invisalign Palatal Expander System K232887 is a FDA 510(k) cleared dental medical device. Manufacturer: Align Technology, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k232892/ 2023-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k232892-hp-detect-stool-antigen-elisa-fda-510k.jpg K232892 - Hp Detect™ Stool Antigen ELISA K232892 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Biomerica, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k232939/ 2023-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k232939-ipl-hair-removal-device-fda-510k.jpg K232939 - IPL Hair Removal Device K232939 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Borria Technology Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k232957/ 2023-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k232957-sterile-and-non-sterile-ultrasound-gels-fda-510k.jpg K232957 - Sterile and Non-Sterile Ultrasound Gels K232957 is a FDA 510(k) cleared radiology medical device. Manufacturer: Jianerkang Medical Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k233182/ 2023-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k233182-powder-free-nitrile-examination-gloves-fda-510k.jpg K233182 - Powder Free Nitrile Examination Gloves (Blue, White, Black and/or Violet Blue) K233182 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zibo Kaiyue Mould Technology Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k233237/ 2023-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k233237-xeo-family-fda-510k.jpg K233237 - xeo+ Family K233237 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cutera, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k233564/ 2023-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k233564-fluobeam-lx-imaging-system-fb-lx-fda-510k.jpg K233564 - FLUOBEAM® LX Imaging System (FB-LX) K233564 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Fluoptics Sas (A Getinge Group Company). Cleared Dec 2023. https://www.510kdatabase.net/k233607/ 2023-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k233607-magnetos-easypack-putty-fda-510k.jpg K233607 - MagnetOs Easypack Putty K233607 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Kuros Biosciences B.V. Cleared Dec 2023. https://www.510kdatabase.net/k233668/ 2023-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k233668-auryon-atherectomy-catheter-15-mm-xl-fda-510k.jpg K233668 - Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon Atherectomy Catheter 0.9 mm XL, Hydrophilic Coating (EXM-4011-H000), Auryon Atherectomy Catheter 1.5 mm XL (EXM -4010-0000), Auryon Atherectomy Catheter 0.9 mm XL (EXM-4011-0000) K233668 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Eximo Medical, Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k233681/ 2023-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k233681-confirm-20-minute-incubator-fda-510k.jpg K233681 - ConFirm 20 Minute Incubator K233681 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Dec 2023. https://www.510kdatabase.net/k233682/ 2023-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k233682-verify-spore-test-strip-for-s40-fda-510k.jpg K233682 - VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE K233682 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Dec 2023. https://www.510kdatabase.net/den230050/ 2023-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/den230050-body-temperature-software-bts-fda-510k.jpg DEN230050 - Body Temperature Software (BTS) DEN230050 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Fitbit, LLC. Cleared Dec 2023. https://www.510kdatabase.net/k223470/ 2023-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k223470-c50-fda-510k.jpg K223470 - C50 K223470 is a FDA 510(k) cleared dental medical device. Manufacturer: Sopro. Cleared Dec 2023. https://www.510kdatabase.net/k230950/ 2023-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k230950-artis-icono-ve30a-fda-510k.jpg K230950 - ARTIS icono (VE30A) K230950 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k231181/ 2023-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k231181-bright-ct-fda-510k.jpg K231181 - bright CT K231181 is a FDA 510(k) cleared radiology medical device. Manufacturer: Dentium Co., Ltd (Ict Branch). Cleared Dec 2023. https://www.510kdatabase.net/k231570/ 2023-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k231570-strokeviewer-perfusion-fda-510k.jpg K231570 - StrokeViewer Perfusion K231570 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nico-Lab B.V.. Cleared Dec 2023. https://www.510kdatabase.net/k231645/ 2023-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k231645-pherdal-at-home-insemination-kit-fda-510k.jpg K231645 - PherDal® At-Home Insemination Kit K231645 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Pherdal Fertility Science, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k231721/ 2023-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k231721-disposable-hot-biopsy-forceps-fda-510k.jpg K231721 - Disposable Hot Biopsy Forceps K231721 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Beijing Zksk Technology Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k231801/ 2023-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k231801-medhealth-dvt-compression-devices-fda-510k.jpg K231801 - MedHealth DVT compression Devices MHH900S/MHH900E K231801 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medhealth Medical Limited. Cleared Dec 2023. https://www.510kdatabase.net/k231887/ 2023-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k231887-arix-ankle-distal-tibia-system-fda-510k.jpg K231887 - ARIX Ankle Distal Tibia System K231887 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Jeil Medical Corporation. Cleared Dec 2023. https://www.510kdatabase.net/k232283/ 2023-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k232283-physoftams-fda-510k.jpg K232283 - PhySoftAMS® K232283 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Physician Software Systems, LLC. Cleared Dec 2023. https://www.510kdatabase.net/k232401/ 2023-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k232401-disposable-veress-needles-fda-510k.jpg K232401 - Disposable Veress Needles K232401 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Hangzhou Kangji Medical Instrument Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k232455/ 2023-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k232455-sofwave-system-fda-510k.jpg K232455 - SofWave System K232455 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Sofwave Medical, Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k232580/ 2023-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k232580-disposable-endobronchial-blocker-tube-fda-510k.jpg K232580 - Disposable Endobronchial Blocker Tube K232580 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Insighters Medical Technology Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k232875/ 2023-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k232875-vial-adapter-20mm-fda-510k.jpg K232875 - Vial Adapter 20mm K232875 is a FDA 510(k) cleared general hospital medical device. Manufacturer: West Pharma Services Il, Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k233227/ 2023-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k233227-velys-robotic-assisted-solution-fda-510k.jpg K233227 - VELYS™ Robotic-Assisted Solution K233227 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Ireland UC. Cleared Dec 2023. https://www.510kdatabase.net/k233374/ 2023-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k233374-secret-pro-fda-510k.jpg K233374 - Secret Pro K233374 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ilooda Co,., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k233647/ 2023-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k233647-versacross-connect-transseptal-dilator-fda-510k.jpg K233647 - VersaCross Connect™ Transseptal Dilator K233647 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baylis Medical Company, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k233648/ 2023-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k233648-millipede-088-access-catheter-fda-510k.jpg K233648 - Millipede 088 Access Catheter K233648 is a FDA 510(k) cleared neurology medical device. Manufacturer: Perfuze, Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k233670/ 2023-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k233670-ascension-silicone-mcp-fda-510k.jpg K233670 - Ascension Silicone MCP K233670 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ascension Orthopedics, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k230742/ 2023-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k230742-acclarent-aera-eustachian-tube-fda-510k.jpg K230742 - ACCLARENT AERA Eustachian Tube Dilation System K230742 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Acclarent, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k230852/ 2023-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k230852-hemosil-chromogenic-factor-ix-fda-510k.jpg K230852 - HemosIL Chromogenic Factor IX K230852 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory Company. Cleared Dec 2023. https://www.510kdatabase.net/k230964/ 2023-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k230964-power-wheelchair-n5909-fda-510k.jpg K230964 - Power Wheelchair (N5909) K230964 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zhejiang Innuovo Rehabilitation Devices Co.,Ltd. Cleared Dec 2023. https://www.510kdatabase.net/k231039/ 2023-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k231039-clearfil-universal-bond-quick-2-fda-510k.jpg K231039 - CLEARFIL Universal Bond Quick 2 K231039 is a FDA 510(k) cleared dental medical device. Manufacturer: Kuraray Noritake Dental, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k231337/ 2023-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k231337-endeavorrx-fda-510k.jpg K231337 - EndeavorRx K231337 is a FDA 510(k) cleared neurology medical device. Manufacturer: Akili Interactive Labs, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k231614/ 2023-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k231614-mirotract-wound-matrix-fda-510k.jpg K231614 - MiroTract Wound Matrix K231614 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Reprise Biomedical, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k231666/ 2023-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k231666-endoscopic-ultrasonic-probe-p2612s-l-fda-510k.jpg K231666 - Endoscopic Ultrasonic Probe (P2612S-L) K231666 is a FDA 510(k) cleared radiology medical device. Manufacturer: Fujifilm Healthcare Americas Corporation. Cleared Dec 2023. https://www.510kdatabase.net/k231803/ 2023-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k231803-neodent-implant-system-zirconia-fda-510k.jpg K231803 - Neodent Implant System - Zirconia Implant System K231803 is a FDA 510(k) cleared dental medical device. Manufacturer: JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A.. Cleared Dec 2023. https://www.510kdatabase.net/k231870/ 2023-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k231870-case-v70-cardiac-testing-system-and-fda-510k.jpg K231870 - CASE V7.0 Cardiac Testing System and CardioSoft V7.0 Cardiac Testing System K231870 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k232063/ 2023-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k232063-salipen-fda-510k.jpg K232063 - SaliPen K232063 is a FDA 510(k) cleared dental medical device. Manufacturer: Saliwell , Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k232077/ 2023-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k232077-atalante-x-fda-510k.jpg K232077 - Atalante X K232077 is a FDA 510(k) cleared neurology medical device. Manufacturer: Wandercraft SAS. Cleared Dec 2023. https://www.510kdatabase.net/k232231/ 2023-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k232231-qp-brain-fda-510k.jpg K232231 - QP-Brain® K232231 is a FDA 510(k) cleared radiology medical device. Manufacturer: Quibim S.L.. Cleared Dec 2023. https://www.510kdatabase.net/k232237/ 2023-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k232237-tyto-insights-for-wheeze-detection-fda-510k.jpg K232237 - Tyto Insights for Wheeze Detection K232237 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Tyto Care , Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k232572/ 2023-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k232572-kalitec-navigated-instrument-system-fda-510k.jpg K232572 - Kalitec Navigated Instrument System K232572 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Kalitec Direct, LLC Doing Business AS Kalitec Medical. Cleared Dec 2023. https://www.510kdatabase.net/k232652/ 2023-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k232652-anatomical-plating-system-various-fda-510k.jpg K232652 - Anatomical Plating System (various) K232652 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tyber Medical, LLC. Cleared Dec 2023. https://www.510kdatabase.net/k232659/ 2023-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k232659-dochek-multi-drug-urine-test-cup-rx-fda-510k.jpg K232659 - Dochek® Multi-Drug Urine Test Cup Rx, Dochek® Multi-Drug Urine Test Cup K232659 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Guangzhou Decheng Biotechnology Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k232680/ 2023-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k232680-fmri-hardware-system-fda-510k.jpg K232680 - fMRI Hardware System K232680 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nordicneurolab AS. Cleared Dec 2023. https://www.510kdatabase.net/k232863/ 2023-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k232863-radiant-renewal-skincare-wand-hd-15-hd-fda-510k.jpg K232863 - Radiant Renewal Skincare Wand (HD-15, HD-15A) K232863 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Kaiyan Medical Equipment Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k232877/ 2023-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k232877-faset-fixation-system-unity-sacroiliac-fda-510k.jpg K232877 - FaSet Fixation System, UNITY Sacroiliac Joint Fixation System, Huvex Interspinous Fixation System, and AEON-C™ Stand Alone System K232877 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: K&J Consulting Corporation. Cleared Dec 2023. https://www.510kdatabase.net/k233019/ 2023-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k233019-alltest-multi-drug-rapid-test-cup-fda-510k.jpg K233019 - AllTest Multi-Drug Rapid Test Cup K233019 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Hangzhou AllTest Biotech Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k233594/ 2023-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k233594-genesys-spine-3dp-ais-c-ii-cervical-fda-510k.jpg K233594 - Genesys Spine 3DP AIS-C II Cervical Interbody System K233594 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Genesys Spine. Cleared Dec 2023. https://www.510kdatabase.net/k233621/ 2023-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k233621-neurostar-advanced-therapy-system-fda-510k.jpg K233621 - NeuroStar Advanced Therapy System (Version 3.8) K233621 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neuronetics. Cleared Dec 2023. https://www.510kdatabase.net/k233663/ 2023-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k233663-n-antisera-to-human-immunoglobulins-fda-510k.jpg K233663 - N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) K233663 is a FDA 510(k) cleared immunology medical device. Manufacturer: Siemens Healthcare Diagnostics Products GmbH. Cleared Dec 2023. https://www.510kdatabase.net/k233688/ 2023-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k233688-sofia-2-sars-antigen-fia-fda-510k.jpg K233688 - Sofia 2 SARS Antigen+ FIA K233688 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Quidel Corporation. Cleared Dec 2023. https://www.510kdatabase.net/k233811/ 2023-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k233811-dt-controlled-phototherapy-equipment-fda-510k.jpg K233811 - DT Controlled Phototherapy Equipment K233811 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Daavlin Distributing Co.. Cleared Dec 2023. https://www.510kdatabase.net/k230872/ 2023-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k230872-halis-lumbar-cage-system-lydia-fda-510k.jpg K230872 - Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction Changeable Lumbar Cage System, KEYSTONE Cage System K230872 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Shanghai Sanyou Medical Co, Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k231669/ 2023-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k231669-ziehm-solo-fd-fda-510k.jpg K231669 - Ziehm Solo FD K231669 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ziehm Imaging GmbH. Cleared Dec 2023. https://www.510kdatabase.net/k232425/ 2023-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k232425-signature-one-system-fda-510k.jpg K232425 - Signature™ ONE System K232425 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthosoft Inc. (d/b/a) Zimmer CAS. Cleared Dec 2023. https://www.510kdatabase.net/k232451/ 2023-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k232451-insulia-bolus-companion-fda-510k.jpg K232451 - Insulia Bolus Companion K232451 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Voluntis Sa.. Cleared Dec 2023. https://www.510kdatabase.net/k232947/ 2023-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k232947-sira-rfa-electrosurgical-device-fda-510k.jpg K232947 - SIRA™ RFA Electrosurgical Device K232947 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Innoblative Designs, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k233037/ 2023-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k233037-sterile-hypodermic-needles-for-single-fda-510k.jpg K233037 - Sterile Hypodermic Needles for Single Use K233037 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zhejiang Kindly Medical Device Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k233222/ 2023-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k233222-aygn-sterilization-container-systems-fda-510k.jpg K233222 - Aygün Sterilization Container Systems K233222 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Aygun Surgical Instruments Co., Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k233455/ 2023-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k233455-arx-mis-spinal-screw-system-fda-510k.jpg K233455 - ARx MIS Spinal Screw System K233455 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k233634/ 2023-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k233634-telescan-fda-510k.jpg K233634 - TeleScan K233634 is a FDA 510(k) cleared radiology medical device. Manufacturer: Bb Imaging. Cleared Dec 2023. https://www.510kdatabase.net/k233645/ 2023-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k233645-stonesmart-connect-console-lithovue-fda-510k.jpg K233645 - StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection K233645 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Dec 2023. https://www.510kdatabase.net/k233646/ 2023-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k233646-intri24-introducer-sheath-52-101-fda-510k.jpg K233646 - Intri24 Introducer Sheath (52-101) K233646 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inari Medical, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k233684/ 2023-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k233684-trialtis-spine-system-fda-510k.jpg K233684 - TriALTIS™ Spine System K233684 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International SARL. Cleared Dec 2023. https://www.510kdatabase.net/den230027/ 2023-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/den230027-navicam-proscan-fda-510k.jpg DEN230027 - NaviCam ProScan DEN230027 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ankon Technologies Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k223340/ 2023-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k223340-eds-calculus-softener-turbo-cr-fda-510k.jpg K223340 - EDS Calculus Softener TURBO CR K223340 is a FDA 510(k) cleared dental medical device. Manufacturer: Essential Dental Systems, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k223690/ 2023-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k223690-iflash-hcg-fda-510k.jpg K223690 - iFlash-HCG K223690 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Shenzhen Yhlo Biotech Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k232096/ 2023-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k232096-transpara-density-100-fda-510k.jpg K232096 - Transpara Density 1.0.0 K232096 is a FDA 510(k) cleared radiology medical device. Manufacturer: Screenpoint Medical B.V.. Cleared Dec 2023. https://www.510kdatabase.net/k232290/ 2023-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k232290-intellio-shift-system-fda-510k.jpg K232290 - INTELLIO SHIFT System K232290 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: ArthroCare Corporation. Cleared Dec 2023. https://www.510kdatabase.net/k232303/ 2023-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k232303-attune-porous-fixed-bearing-tibial-fda-510k.jpg K232303 - ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology K232303 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Ireland UC. Cleared Dec 2023. https://www.510kdatabase.net/k232797/ 2023-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k232797-hygenix-fda-510k.jpg K232797 - Hygenix K232797 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen Hygenix Industrial Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k232815/ 2023-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k232815-wrist-blood-pressure-monitor-fda-510k.jpg K232815 - Wrist Blood Pressure Monitor K232815 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Zhuhai Yueja Medical Device Technology Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k232985/ 2023-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k232985-24hr513c-fda-510k.jpg K232985 - 24HR513C K232985 is a FDA 510(k) cleared radiology medical device. Manufacturer: Lg Electronics.Inc. Cleared Dec 2023. https://www.510kdatabase.net/k233248/ 2023-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k233248-faradrive-steerable-sheath-fda-510k.jpg K233248 - FARADRIVE™ Steerable Sheath K233248 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Dec 2023. https://www.510kdatabase.net/k233693/ 2023-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k233693-nio-color-8mp-mdnc-8132-fda-510k.jpg K233693 - Nio Color 8MP (MDNC-8132) K233693 is a FDA 510(k) cleared radiology medical device. Manufacturer: Barco N.V.. Cleared Dec 2023. https://www.510kdatabase.net/k221851/ 2023-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k221851-lumina-ptfe-titanium-fda-510k.jpg K221851 - Lumina-PTFE Titanium K221851 is a FDA 510(k) cleared dental medical device. Manufacturer: Criteria Industria E Comercio DE Produtos Medicinais. Cleared Dec 2023. https://www.510kdatabase.net/k223757/ 2023-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k223757-bonelogic-fda-510k.jpg K223757 - Bonelogic K223757 is a FDA 510(k) cleared radiology medical device. Manufacturer: Disior, Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k230722/ 2023-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k230722-eagle-device-fda-510k.jpg K230722 - Eagle device K230722 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Belkin Vision, Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k231061/ 2023-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k231061-neuroblate-system-fda-510k.jpg K231061 - NeuroBlate System K231061 is a FDA 510(k) cleared neurology medical device. Manufacturer: Monteris Medical,. Cleared Dec 2023. https://www.510kdatabase.net/k231743/ 2023-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k231743-f3d-lateral-lumbar-interbody-system-fda-510k.jpg K231743 - F3D Lateral Lumbar Interbody System, CL5 Lateral Lumbar Interbody System, and Oro Lateral Plate System K231743 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corelink, LLC. Cleared Dec 2023. https://www.510kdatabase.net/k231898/ 2023-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k231898-dtx-studio-clinic-40-fda-510k.jpg K231898 - DTX Studio Clinic (4.0) K231898 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nobel Biocare AB. Cleared Dec 2023. https://www.510kdatabase.net/k231964/ 2023-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k231964-novii-wireless-patch-system-fda-510k.jpg K231964 - Novii+ Wireless Patch System K231964 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Datex-Ohmeda. Cleared Dec 2023. https://www.510kdatabase.net/k232053/ 2023-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k232053-simplesense-bp-simplesense-bp-software-fda-510k.jpg K232053 - SimpleSense-BP, SimpleSense-BP Software Application K232053 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nanowear, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k232085/ 2023-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k232085-dvas-dvas-m-dvas-w-fda-510k.jpg K232085 - DVAS (DVAS-M, DVAS-W) K232085 is a FDA 510(k) cleared radiology medical device. Manufacturer: Genoray Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k232515/ 2023-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k232515-valkyrie-thoracic-fixation-system-fda-510k.jpg K232515 - Valkyrie Thoracic Fixation System K232515 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices. Cleared Dec 2023. https://www.510kdatabase.net/k232517/ 2023-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k232517-transcutaneous-electrical-nerve-fda-510k.jpg K232517 - Transcutaneous Electrical Nerve Stimulator For Pain Relief (Model: KTR-2302, KTR-2401, KTR-2402, KTR-2411, KTR-2412) K232517 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Kentro Medical Electronics Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k232737/ 2023-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k232737-powerport-clearvue-slim-ecg-enabled-fda-510k.jpg K232737 - PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port K232737 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bard Peripheral Vascular, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k232750/ 2023-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k232750-bti-interna-prosthetic-components-fda-510k.jpg K232750 - BTI Interna Prosthetic Components K232750 is a FDA 510(k) cleared dental medical device. Manufacturer: B.T.I. Biotechnology Institute, Sl.. Cleared Dec 2023. https://www.510kdatabase.net/k232830/ 2023-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k232830-vibrant-system-fda-510k.jpg K232830 - Vibrant System K232830 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Vibrant, Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k233261/ 2023-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k233261-global-modular-replacement-system-fda-510k.jpg K233261 - Global Modular Replacement System K233261 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. Cleared Dec 2023. https://www.510kdatabase.net/k233432/ 2023-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k233432-10f-sheath-and-dilator-set-fda-510k.jpg K233432 - 10F Sheath and Dilator Set K233432 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Argon Medical Devices, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k233654/ 2023-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k233654-verify-chemical-indicator-for-system-fda-510k.jpg K233654 - VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems K233654 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Steris. Cleared Dec 2023. https://www.510kdatabase.net/k230137/ 2023-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k230137-reliance-fusion-sterilization-wraps-fda-510k.jpg K230137 - Reliance® Fusion Sterilization Wraps K230137 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ahlstrom-Munksjo Nonwovens, LLC. Cleared Dec 2023. https://www.510kdatabase.net/k231127/ 2023-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k231127-sin-dental-implant-system-fda-510k.jpg K231127 - S.I.N. Dental Implant System K231127 is a FDA 510(k) cleared dental medical device. Manufacturer: S.I.N. ? Sistema DE Implante Nacional S.A.. Cleared Dec 2023. https://www.510kdatabase.net/k231206/ 2023-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k231206-dlp-silicone-coronary-artery-ostial-fda-510k.jpg K231206 - DLP Silicone Coronary Artery Ostial Cannulae K231206 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k231515/ 2023-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k231515-myspine-cervical-guides-fda-510k.jpg K231515 - MySpine Cervical Guides K231515 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Dec 2023. https://www.510kdatabase.net/k231967/ 2023-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k231967-ari-excon-implant-system-fda-510k.jpg K231967 - ARi ExCon Implant System K231967 is a FDA 510(k) cleared dental medical device. Manufacturer: Megagen Implant Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k232273/ 2023-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k232273-rm-electrode-rmh-23-01-fda-510k.jpg K232273 - RM Electrode (RMH 23-01) K232273 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Retmap, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k232381/ 2023-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k232381-logiq-totus-fda-510k.jpg K232381 - LOGIQ Totus K232381 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared Dec 2023. https://www.510kdatabase.net/k232661/ 2023-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k232661-myocardial-strain-software-application-fda-510k.jpg K232661 - Myocardial Strain Software Application K232661 is a FDA 510(k) cleared radiology medical device. Manufacturer: Circle Cardiovascular Imaging. Cleared Dec 2023. https://www.510kdatabase.net/k232761/ 2023-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k232761-pronephro-aki-ngal-fda-510k.jpg K232761 - ProNephro AKI™ (NGAL) K232761 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bioporto Diagnostic, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k232795/ 2023-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k232795-led-mask-platinum-exclusive-md-fda-510k.jpg K232795 - Led Mask Platinum Exclusive MD K232795 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stg24 Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k232846/ 2023-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k232846-light-based-hair-removal-device-fda-510k.jpg K232846 - Light Based Hair Removal Device K232846 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Meik Beauty Industry Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k233429/ 2023-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k233429-ots-25-100-1-fda-510k.jpg K233429 - OTS 25 (100-1) K233429 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ots Medical , Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k222930/ 2023-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k222930-evolve-nitric-oxide-delivery-system-fda-510k.jpg K222930 - Evolve Nitric Oxide Delivery System K222930 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Mallinckrodt Manufacturing, LLC. Cleared Dec 2023. https://www.510kdatabase.net/k230677/ 2023-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k230677-cork-medical-versa-negative-pressure-fda-510k.jpg K230677 - Cork Medical VERSA Negative Pressure Wound System (VCMPP-100) K230677 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cork Medical. Cleared Dec 2023. https://www.510kdatabase.net/k230712/ 2023-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k230712-sg-lanset-i-sg-lancets-soft-lancets-fda-510k.jpg K230712 - SG Lanset I, SG Lancets, Soft Lancets K230712 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sewon Medical Co.. Cleared Dec 2023. https://www.510kdatabase.net/k231125/ 2023-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k231125-2008t-bluestar-hemodialysis-machine-fda-510k.jpg K231125 - 2008T BlueStar Hemodialysis Machine K231125 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC. Cleared Dec 2023. https://www.510kdatabase.net/k231465/ 2023-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k231465-q-pad-test-system-fda-510k.jpg K231465 - Q-Pad Test System K231465 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Qurasense. Cleared Dec 2023. https://www.510kdatabase.net/k231675/ 2023-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k231675-onerf-ablation-system-fda-510k.jpg K231675 - OneRF Ablation System K231675 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neuroone Medical Technologies Corp.. Cleared Dec 2023. https://www.510kdatabase.net/k232206/ 2023-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k232206-somatom-propulse-fda-510k.jpg K232206 - SOMATOM Pro.Pulse K232206 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k232769/ 2023-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k232769-beamed-laser-surgery-fibers-fda-510k.jpg K232769 - BeaMed Laser Surgery Fibers K232769 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bt Beamedical Tachnoogies Ltd. (Beamed). Cleared Dec 2023. https://www.510kdatabase.net/k233042/ 2023-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k233042-sterile-nitrile-examination-gloves-fda-510k.jpg K233042 - Sterile Nitrile Examination Gloves Powder Free Tested for Use with Chemotherapy Drugs and Fentanyl Citrate K233042 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shandong Intco Medical Products Co, Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k233334/ 2023-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k233334-aquilion-serve-sp-tsx-307b1-v13-fda-510k.jpg K233334 - Aquilion Serve SP (TSX-307B/1) V1.3 K233334 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Dec 2023. https://www.510kdatabase.net/k233521/ 2023-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k233521-qt-ecg-qterd100-fda-510k.jpg K233521 - QT ECG (QTERD100) K233521 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: QT Medical, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k233562/ 2023-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k233562-linq-ii-insertable-cardiac-monitor-fda-510k.jpg K233562 - LINQ II Insertable Cardiac Monitor K233562 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k233597/ 2023-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k233597-sonosite-lx-ultrasound-system-fda-510k.jpg K233597 - Sonosite LX Ultrasound System K233597 is a FDA 510(k) cleared radiology medical device. Manufacturer: FUJIFILM Sonosite, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k222057/ 2023-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k222057-thermoclick-fda-510k.jpg K222057 - THERMOCLICK K222057 is a FDA 510(k) cleared general hospital medical device. Manufacturer: T&R BIOFAB CO., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k223170/ 2023-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k223170-electronic-blood-pressure-monitor-fda-510k.jpg K223170 - Electronic Blood Pressure Monitor, model: HTD6602US K223170 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hetaida Technology Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k230734/ 2023-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k230734-multispectral-imager-kit-msi-kit-300-fda-510k.jpg K230734 - Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009) K230734 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Precision Healing, LLC. Cleared Dec 2023. https://www.510kdatabase.net/k231005/ 2023-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k231005-aurelia-surgical-mask-astm-level-1-fda-510k.jpg K231005 - Aurelia Surgical Mask ASTM Level 1 K231005 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Supermax Healthcare Canada-Supermax Medical. Cleared Dec 2023. https://www.510kdatabase.net/k231230/ 2023-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k231230-optina-4c-mhrc-c1n-fda-510k.jpg K231230 - Optina-4C (MHRC-C1N) K231230 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Optina Diagnostics, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k231615/ 2023-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k231615-disposable-endoscopic-bipolar-fda-510k.jpg K231615 - Disposable Endoscopic Bipolar K231615 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Jiangsu Hope Biomedical Science & Technology Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k231923/ 2023-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k231923-liberty-si-lateral-implant-system-fda-510k.jpg K231923 - Liberty SI Lateral Implant System K231923 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinal Simplicity, LLC. Cleared Dec 2023. https://www.510kdatabase.net/k232220/ 2023-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k232220-ss-abutment-system-fda-510k.jpg K232220 - SS Abutment System K232220 is a FDA 510(k) cleared dental medical device. Manufacturer: Osstem Implant Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k232434/ 2023-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k232434-bd-veritor-system-for-rapid-detection-fda-510k.jpg K232434 - BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit K232434 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd. Cleared Dec 2023. https://www.510kdatabase.net/k232440/ 2023-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k232440-adravision-perio-fda-510k.jpg K232440 - Adravision Perio K232440 is a FDA 510(k) cleared radiology medical device. Manufacturer: Adra Corporation. Cleared Dec 2023. https://www.510kdatabase.net/k232814/ 2023-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k232814-electronic-blood-pressure-monitor-fda-510k.jpg K232814 - Electronic Blood Pressure Monitor K232814 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Zhuhai Yueja Medical Device Technology Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k233335/ 2023-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k233335-tablo-hemodialysis-system-fda-510k.jpg K233335 - Tablo® Hemodialysis System K233335 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Outset Medical, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k233490/ 2023-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k233490-signafuse-bioactive-strip-sbs-fda-510k.jpg K233490 - SIGNAFUSE Bioactive Strip (SBS) K233490 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Bioventus, LLC. Cleared Dec 2023. https://www.510kdatabase.net/k233568/ 2023-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k233568-ceevra-reveal-3-fda-510k.jpg K233568 - Ceevra Reveal 3+ K233568 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ceevra, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k220525/ 2023-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k220525-responder-polysaccharide-hemostat-fda-510k.jpg K220525 - RESPONDER Polysaccharide Hemostat K220525 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Starch Medical, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k223783/ 2023-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k223783-cobas-sars-cov-2-nucleic-acid-test-for-fda-510k.jpg K223783 - cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System K223783 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Molecular Systems, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k230648/ 2023-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k230648-access-hstni-fda-510k.jpg K230648 - Access hsTnI K230648 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k230724/ 2023-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k230724-arcad-20-duo-quadro-osteosynthesis-fda-510k.jpg K230724 - arcad® 2.0 Duo & Quadro osteosynthesis compressive staples K230724 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Novastep. Cleared Dec 2023. https://www.510kdatabase.net/k231895/ 2023-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k231895-maxtec-maxblend2p-fda-510k.jpg K231895 - Maxtec MaxBlend2+p K231895 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Maxtec, LLC. Cleared Dec 2023. https://www.510kdatabase.net/k232308/ 2023-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k232308-monarch-blood-collection-set-fda-510k.jpg K232308 - Monarch Blood Collection Set K232308 is a FDA 510(k) cleared general hospital medical device. Manufacturer: The Monarch Company. Cleared Dec 2023. https://www.510kdatabase.net/k232581/ 2023-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k232581-medical-disposable-sterile-needle-fda-510k.jpg K232581 - Medical Disposable Sterile Needle Electrode K232581 is a FDA 510(k) cleared neurology medical device. Manufacturer: Suzhou Haishen Medical Device Associates Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k232693/ 2023-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k232693-tyber-medical-distal-radius-plating-fda-510k.jpg K232693 - Tyber Medical Distal Radius Plating System K232693 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tyber Medical, LLC. Cleared Dec 2023. https://www.510kdatabase.net/k232932/ 2023-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k232932-intense-pulse-light-therapeutic-fda-510k.jpg K232932 - Intense Pulse Light Therapeutic Apparatus K232932 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Greatro Electronic Technology Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k233347/ 2023-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k233347-verruca-freeze-h-fda-510k.jpg K233347 - Verruca-Freeze® H K233347 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cryosurgery, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/den230045/ 2023-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/den230045-sonu-fda-510k.jpg DEN230045 - Sonu DEN230045 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Sound Health Systems, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k233397/ 2023-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k233397-cosine-10tm-diagnostic-catheter-fda-510k.jpg K233397 - Cosine-10TM Diagnostic Catheter K233397 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k230391/ 2023-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k230391-bd-minidraw-capillary-blood-collection-fda-510k.jpg K230391 - BD MiniDraw™ Capillary Blood Collection System with BD MiniDraw™ SST™ Capillary Blood Collection Tube K230391 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Becton, Dickinson and Company. Cleared Dec 2023. https://www.510kdatabase.net/k230528/ 2023-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k230528-extension-set-fda-510k.jpg K230528 - Extension Set K230528 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medcaptain Life Science Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k230621/ 2023-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k230621-laproglide-disposable-monopolar-ptfe-fda-510k.jpg K230621 - LaproGlide™ Disposable Monopolar PTFE Coated Laparoscopic Probes K230621 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Surgical Principals, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k230639/ 2023-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k230639-align-cervical-interbody-fusion-system-fda-510k.jpg K230639 - Align Cervical Interbody Fusion System K230639 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Acuity Surgical Devices, LLC. Cleared Dec 2023. https://www.510kdatabase.net/k230988/ 2023-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k230988-vial2bag-advanced-13mm-admixture-device-fda-510k.jpg K230988 - Vial2Bag Advanced® 13mm Admixture Device K230988 is a FDA 510(k) cleared general hospital medical device. Manufacturer: West Pharma Services Il, Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k231057/ 2023-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k231057-antibacterial-gel-wound-dressing-fda-510k.jpg K231057 - Antibacterial Gel Wound Dressing K231057 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Winner Medical Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k231179/ 2023-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k231179-slinky-catheter-fda-510k.jpg K231179 - Slinky Catheter K231179 is a FDA 510(k) cleared neurology medical device. Manufacturer: Anoxia Medical, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k231211/ 2023-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k231211-medline-comforttemp-patient-warming-fda-510k.jpg K231211 - Medline ComfortTemp Patient Warming System K231211 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medline Industries, LP. Cleared Dec 2023. https://www.510kdatabase.net/k231272/ 2023-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k231272-ossiofiber-pin-product-family-fda-510k.jpg K231272 - OSSIOfiber® Pin Product Family, OSSIOfiber® Compression Screw, OSSIOfiber® Trimmable Fixation Nail K231272 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OSSIO , Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k231476/ 2023-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k231476-trueness-air-blood-glucose-monitoring-fda-510k.jpg K231476 - TRUENESS™ AIR Blood Glucose Monitoring System K231476 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sinocare, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k231817/ 2023-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k231817-alignerflow-lc-fda-510k.jpg K231817 - AlignerFlow LC K231817 is a FDA 510(k) cleared dental medical device. Manufacturer: Voco GmbH. Cleared Dec 2023. https://www.510kdatabase.net/k232093/ 2023-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k232093-woo-more-play-coconut-love-oil-fda-510k.jpg K232093 - Woo More Play Coconut Love Oil K232093 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Woo Essentials, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k232249/ 2023-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k232249-pentax-medical-gaswater-feeding-valve-fda-510k.jpg K232249 - PENTAX Medical Gas/Water Feeding Valve OE-B14 K232249 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Pentax of America, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k232418/ 2023-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k232418-single-platform-sp1-implant-system-fda-510k.jpg K232418 - Single Platform SP1 Implant System K232418 is a FDA 510(k) cleared dental medical device. Manufacturer: Southern Implants (Pty), Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k232438/ 2023-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k232438-dental-glass-ceramics-blocks-fda-510k.jpg K232438 - Dental Glass Ceramics Blocks K232438 is a FDA 510(k) cleared dental medical device. Manufacturer: Aibodent Biotechnology Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k232708/ 2023-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k232708-intense-pulsed-light-therapy-device-fda-510k.jpg K232708 - Intense pulsed light therapy device K232708 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Hebei Zhemai Technology Co., Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k232758/ 2023-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k232758-comatryx-otc-fda-510k.jpg K232758 - Comatryx OTC K232758 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Strukmyer Medical, LLC. Cleared Dec 2023. https://www.510kdatabase.net/k232856/ 2023-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k232856-syngo-carbon-clinicals-fda-510k.jpg K232856 - Syngo Carbon Clinicals K232856 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Healthcare GmbH. Cleared Dec 2023. https://www.510kdatabase.net/k233149/ 2023-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k233149-cathtong-iii-tapered-picc-catheter-fda-510k.jpg K233149 - CATHTONG III Tapered PICC Catheter K233149 is a FDA 510(k) cleared general hospital medical device. Manufacturer: L&Z Us, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k233159/ 2023-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k233159-pureflow-402-pureflow-400-pureflow-406-fda-510k.jpg K233159 - pureFLOW 402, pureFLOW 400, pureFLOW 406, pureFLOW 401, pureFLOW 502, pureFLOW 504 K233159 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC. Cleared Dec 2023. https://www.510kdatabase.net/k233301/ 2023-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k233301-ultrapulse-alpha-co2-laser-system-fda-510k.jpg K233301 - ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories K233301 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lumenis Be, Ltd.. Cleared Dec 2023. https://www.510kdatabase.net/k233529/ 2023-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k233529-bd-nexiva-diffusics-closed-iv-catheter-fda-510k.jpg K233529 - BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ Needle-free Connector K233529 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton Dickinson Infusion Therapy Systems, Inc.. Cleared Dec 2023. https://www.510kdatabase.net/k221787/ 2023-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k221787-auxeins-dhsdcs-plate-system-fda-510k.jpg K221787 - Auxein's DHS/DCS Plate System K221787 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Auxein Medical Private Limited. Cleared Nov 2023. https://www.510kdatabase.net/k230061/ 2023-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k230061-insulin-syringe-fda-510k.jpg K230061 - Insulin Syringe K230061 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k230587/ 2023-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k230587-wrist-pulse-oximeter-fda-510k.jpg K230587 - Wrist Pulse Oximeter K230587 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Beijing Choice Electronic Technology Co., Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k230669/ 2023-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k230669-l-cath-single-and-dual-lumen-catheters-fda-510k.jpg K230669 - L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline Catheters K230669 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Argon Medical Devices. Cleared Nov 2023. https://www.510kdatabase.net/k231393/ 2023-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k231393-radical-the-dude-7f-guide-catheter-fda-510k.jpg K231393 - Radical the Dude 7F Guide Catheter K231393 is a FDA 510(k) cleared neurology medical device. Manufacturer: Maduro Medical, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k231546/ 2023-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k231546-somfit-fda-510k.jpg K231546 - Somfit K231546 is a FDA 510(k) cleared neurology medical device. Manufacturer: Compumedics Limited. Cleared Nov 2023. https://www.510kdatabase.net/k231877/ 2023-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k231877-navaclick-injection-system-fda-510k.jpg K231877 - NavaClick Injection System K231877 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Lineage Biomedical, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k232155/ 2023-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k232155-syngoct-dual-energy-fda-510k.jpg K232155 - syngo.CT Dual Energy K232155 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k232262/ 2023-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k232262-lumeneye-x1-endoscope-lx1-scp-203-fda-510k.jpg K232262 - LumenEye® X1 endoscope (LX1-SCP-203) K232262 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Surgease Innovations Limited. Cleared Nov 2023. https://www.510kdatabase.net/k232611/ 2023-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k232611-trulift-micro-expandable-spacer-system-fda-510k.jpg K232611 - TruLift Micro Expandable Spacer System & TruLift Expandable Spacer System K232611 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k232709/ 2023-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k232709-diode-laser-therapy-device-fda-510k.jpg K232709 - Diode laser therapy device K232709 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Hebei Zhemai Technology Co., Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k232716/ 2023-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k232716-q-switched-ndyag-laser-fda-510k.jpg K232716 - Q-Switched Nd:Yag laser K232716 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Hebei Zhemai Technology Co., Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k233500/ 2023-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k233500-benesta-tissue-removal-device-fda-510k.jpg K233500 - Benesta Tissue Removal Device K233500 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Caldera Medical, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k233503/ 2023-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k233503-14f-isleeve-introducer-set-fda-510k.jpg K233503 - 14F iSLEEVE Introducer Set K233503 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Nov 2023. https://www.510kdatabase.net/k233545/ 2023-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k233545-epiq-series-diagnostic-ultrasound-system-fda-510k.jpg K233545 - EPIQ Series Diagnostic Ultrasound System K233545 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Ultrasound, LLC. Cleared Nov 2023. https://www.510kdatabase.net/k233552/ 2023-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k233552-ideal-ziploop-fda-510k.jpg K233552 - IDEAL Ziploop K233552 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Riverpoint Medical. Cleared Nov 2023. https://www.510kdatabase.net/k230179/ 2023-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k230179-6440-mylabx90-fda-510k.jpg K230179 - 6440 MyLabX90 K230179 is a FDA 510(k) cleared radiology medical device. Manufacturer: Esaote, S.P.A.. Cleared Nov 2023. https://www.510kdatabase.net/k230646/ 2023-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k230646-surecore-prime-biopsy-instrument-fda-510k.jpg K230646 - SUREcore Prime Biopsy Instrument K230646 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Uro-1 Medical, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k230726/ 2023-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k230726-cereglide-92-intermediate-catheter-fda-510k.jpg K230726 - CEREGLIDE 92 Intermediate Catheter K230726 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cerenovus, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k231203/ 2023-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k231203-mosie-baby-kit-fda-510k.jpg K231203 - Mosie Baby Kit K231203 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Mosie Baby. Cleared Nov 2023. https://www.510kdatabase.net/k231482/ 2023-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k231482-uct-atlas-astound-with-uws-ct-dual-fda-510k.jpg K231482 - uCT ATLAS Astound with uWS-CT-Dual Energy Analysis, uCT ATLAS with uWS-CT-Dual Energy Analysis K231482 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k231821/ 2023-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k231821-xo-cath-microcatheter-e20-090-s-e20-fda-510k.jpg K231821 - XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,) K231821 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Transit Scientific, LLC. Cleared Nov 2023. https://www.510kdatabase.net/k232033/ 2023-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k232033-hybridknife-flex-fda-510k.jpg K232033 - HYBRIDknife® flex K232033 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Erbe Elektromedizin GmbH. Cleared Nov 2023. https://www.510kdatabase.net/k232069/ 2023-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k232069-expandable-lumbar-fusion-cage-type-fda-510k.jpg K232069 - Expandable Lumbar Fusion Cage (Type I,Type II) K232069 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Shanghai Reach Medical Instrument Co, Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k232244/ 2023-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k232244-disposable-endoscope-valves-system-fda-510k.jpg K232244 - Disposable Endoscope Valves System K232244 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Changzhou Endoclean Medical Device Co., Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k232684/ 2023-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k232684-surgify-halo-fda-510k.jpg K232684 - Surgify Halo K232684 is a FDA 510(k) cleared neurology medical device. Manufacturer: Surgify Medical OY. Cleared Nov 2023. https://www.510kdatabase.net/k232772/ 2023-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k232772-blood-pressure-cuff-1201d112l2d11202d112-fda-510k.jpg K232772 - Blood Pressure Cuff (1201D1,12L2D1,1202D1,12L3D1,1203D1,1204D1,1205D1,1206D1,1207D1-1#,1207D1-2#,1207D1-3#,1207D1-4#,1207D1-5#,1201B1,12L2B1,1202B1,12L3B1,1203B1,1204B1,1205B1,1206B1,1207B1-1#,1207B1-2#,,1207B1-3#,1207B1-4#,1207B1-5#,1201W2,12L2W2,1202W2,12L3W2,1203W2,1204W2,1205W2,1206W2 and 1207W2) K232772 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Plinma Technology Co. , Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k233527/ 2023-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k233527-minuteman-g5-mis-fusion-plate-fda-510k.jpg K233527 - Minuteman G5 MIS Fusion Plate K233527 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinal Simplicity, LLC. Cleared Nov 2023. https://www.510kdatabase.net/k233532/ 2023-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k233532-multix-impact-e-fda-510k.jpg K233532 - MULTIX Impact E K233532 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions. Cleared Nov 2023. https://www.510kdatabase.net/k222845/ 2023-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k222845-clench-relief-mouth-piece-pro-rx-fda-510k.jpg K222845 - Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece K222845 is a FDA 510(k) cleared dental medical device. Manufacturer: Frey Oral Technologies, LLC. Cleared Nov 2023. https://www.510kdatabase.net/k230883/ 2023-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k230883-versapump-infusion-system-fda-510k.jpg K230883 - VersaPump Infusion System K230883 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Emed Technologies Corporation. Cleared Nov 2023. https://www.510kdatabase.net/k230947/ 2023-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k230947-care-appliance-dna-mrna-mmrna-fda-510k.jpg K230947 - C.A.R.E. Appliance (DNA, mRNA, mmRNA) K230947 is a FDA 510(k) cleared dental medical device. Manufacturer: Vivos Therapeutics, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k231250/ 2023-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k231250-digital-blood-pressure-monitor-fda-510k.jpg K231250 - Digital Blood Pressure Monitor K231250 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Guangdong Genial Technology Co., Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k231473/ 2023-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k231473-monarch-bronchoscope-fda-510k.jpg K231473 - Monarch Bronchoscope K231473 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Auris Health, Inc., A Johnson and Johnson Family Company. Cleared Nov 2023. https://www.510kdatabase.net/k231631/ 2023-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k231631-briefcase-quantification-fda-510k.jpg K231631 - BriefCase-Quantification K231631 is a FDA 510(k) cleared radiology medical device. Manufacturer: Aidoc Medical , Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k232000/ 2023-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k232000-syngovia-mi-workflows-fda-510k.jpg K232000 - syngo.via MI Workflows K232000 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k232012/ 2023-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k232012-n1-fda-510k.jpg K232012 - N1 K232012 is a FDA 510(k) cleared radiology medical device. Manufacturer: Osstem Implant Co., Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k232117/ 2023-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k232117-diode-laser-hair-removal-lhr-v6s-1064-fda-510k.jpg K232117 - Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) K232117 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wuhan Lotuxs Technology Co., Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k232252/ 2023-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k232252-nitrile-powder-free-examination-gloves-fda-510k.jpg K232252 - Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange) K232252 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Dehai (Shandong) Medical Gloves, Co., Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k232595/ 2023-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k232595-kinos-axiom-total-ankle-system-fda-510k.jpg K232595 - Kinos Axiom Total Ankle System K232595 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Restor3d. Cleared Nov 2023. https://www.510kdatabase.net/k232633/ 2023-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k232633-gold-probe-bipolar-electrohemostasis-fda-510k.jpg K232633 - Gold Probe Bipolar Electrohemostasis Catheter K232633 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific. Cleared Nov 2023. https://www.510kdatabase.net/k232643/ 2023-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k232643-cue-covid-19-molecular-test-fda-510k.jpg K232643 - Cue COVID-19 Molecular Test K232643 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Cue Health, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k232713/ 2023-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k232713-blood-pressure-monitor-fda-510k.jpg K232713 - Blood Pressure Monitor K232713 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Guangdong Transtek Medical Electronics Co., Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k233414/ 2023-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k233414-shoreline-acs-interbody-system-fda-510k.jpg K233414 - Shoreline ACS Interbody System K233414 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared Nov 2023. https://www.510kdatabase.net/k233493/ 2023-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k233493-tricera-arthroscopic-system-fda-510k.jpg K233493 - Tricera Arthroscopic System K233493 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Relign Corporation. Cleared Nov 2023. https://www.510kdatabase.net/k230379/ 2023-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k230379-portable-ultrasonic-nebulizer-fda-510k.jpg K230379 - Portable (Ultrasonic) Nebulizer K230379 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Dongguan Simzo Electronic Technology Co., Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k230493/ 2023-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k230493-bd-minidraw-capillary-blood-collection-fda-510k.jpg K230493 - BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube K230493 is a FDA 510(k) cleared hematology medical device. Manufacturer: Becton, Dickinson and Company. Cleared Nov 2023. https://www.510kdatabase.net/k231104/ 2023-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k231104-abpmpro-fda-510k.jpg K231104 - ABPMpro K231104 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Somnomedics GmbH. Cleared Nov 2023. https://www.510kdatabase.net/k231661/ 2023-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k231661-cryothin-surgical-system-and-accessories-fda-510k.jpg K231661 - CryoThin™ Surgical System and Accessories K231661 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medinux (Tianjin) Technologies Co., Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k232222/ 2023-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k232222-primo-dental-laser-primo-primo-komfort-fda-510k.jpg K232222 - Primo Dental Laser (Primo, Primo Komfort, Primo Lite, Primo Blue, and Primo Triplo) K232222 is a FDA 510(k) cleared dental medical device. Manufacturer: Medency S.R.L.. Cleared Nov 2023. https://www.510kdatabase.net/k232624/ 2023-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k232624-cardiophase-hscrp-fda-510k.jpg K232624 - CardioPhase® hsCRP K232624 is a FDA 510(k) cleared immunology medical device. Manufacturer: Siemens Healthcare Diagnostic Products GmbH. Cleared Nov 2023. https://www.510kdatabase.net/k232658/ 2023-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k232658-t-top-10-t-top-t-top-11-fda-510k.jpg K232658 - T-Top 10 & T-Top T-Top 11 K232658 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Tuttnauer U.S.A Co, Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k233171/ 2023-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k233171-pf-keep-fda-510k.jpg K233171 - PF Keep K233171 is a FDA 510(k) cleared dental medical device. Manufacturer: Clemde SA DE CV. Cleared Nov 2023. https://www.510kdatabase.net/k233243/ 2023-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k233243-clearpoint-system-software-version-22-fda-510k.jpg K233243 - ClearPoint System (Software Version 2.2) K233243 is a FDA 510(k) cleared neurology medical device. Manufacturer: ClearPoint Neuro, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k233332/ 2023-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k233332-statera-c-spinal-system-fda-510k.jpg K233332 - Statera-C™ Spinal System K233332 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: K&J Consulting Corp.. Cleared Nov 2023. https://www.510kdatabase.net/k233343/ 2023-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k233343-stericap-safety-needle-fda-510k.jpg K233343 - SteriCap Safety Needle K233343 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ocuject, LLC. Cleared Nov 2023. https://www.510kdatabase.net/k233160/ 2023-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k233160-neutrace-ep-mapping-system-v21-fda-510k.jpg K233160 - NeuTrace EP Mapping System v.2.1 K233160 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Anumana, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k230311/ 2023-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k230311-hypersuture-fda-510k.jpg K230311 - HyperSuture K230311 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Threadstone, LLC. Cleared Nov 2023. https://www.510kdatabase.net/k230319/ 2023-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k230319-passio-pump-drainage-system-fda-510k.jpg K230319 - Passio Pump Drainage System K230319 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Bearpac Medical. Cleared Nov 2023. https://www.510kdatabase.net/k230701/ 2023-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k230701-stim2go-fda-510k.jpg K230701 - Stim2Go K230701 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: PAJUNK GmbH Medizintechnologie. Cleared Nov 2023. https://www.510kdatabase.net/k232059/ 2023-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k232059-tympanostomy-tubes-fda-510k.jpg K232059 - Tympanostomy Tubes K232059 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Grace Medical, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k233525/ 2023-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k233525-mf-sc-facial-toning-system-fda-510k.jpg K233525 - MF SC Facial Toning System K233525 is a FDA 510(k) cleared neurology medical device. Manufacturer: Micro Current Technology, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k222499/ 2023-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k222499-disposable-endoscope-valves-kit-fda-510k.jpg K222499 - Disposable Endoscope Valves Kit K222499 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Shanghai SeeGen Photoelectric Technology Co., Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k222712/ 2023-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k222712-fogg-system-patient-monitoring-cables-fda-510k.jpg K222712 - Fogg System Patient Monitoring Cables K222712 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Fogg System Company, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k230529/ 2023-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k230529-healiaid-dental-collagen-wound-dressing-fda-510k.jpg K230529 - HealiAid Dental Collagen Wound Dressing K230529 is a FDA 510(k) cleared dental medical device. Manufacturer: Maxigen Biotech, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k230604/ 2023-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k230604-intellivue-patient-monitor-mx100-fda-510k.jpg K230604 - IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030) K230604 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Philips Medizin Systeme Boeblingen GmbH. Cleared Nov 2023. https://www.510kdatabase.net/k231245/ 2023-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k231245-digital-blood-pressure-monitor-arm-type-fda-510k.jpg K231245 - Digital Blood Pressure Monitor (Arm Type) K231245 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Guangdong Genial Technology Co., Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k231797/ 2023-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k231797-medifun-lancing-device-model-no-ld-e1-fda-510k.jpg K231797 - Medifun Lancing Device, Model No. LD-E1 K231797 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medifun Corporation. Cleared Nov 2023. https://www.510kdatabase.net/k232593/ 2023-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k232593-fitme-customized-silicone-implant-fda-510k.jpg K232593 - FITme Customized Silicone Implant K232593 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Keosan Trading Co.. Cleared Nov 2023. https://www.510kdatabase.net/k232600/ 2023-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k232600-dxflex-flow-cytometer-fda-510k.jpg K232600 - DxFLEX Flow Cytometer K232600 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k232621/ 2023-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k232621-blood-pressure-monitor-fda-510k.jpg K232621 - Blood pressure monitor K232621 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Guangdong Transtek Medical Electronics Co., Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k232635/ 2023-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k232635-iceseed-15-cx-90-needle-h7493967433170-fda-510k.jpg K232635 - IceSeed 1.5 CX 90º Needle (H7493967433170) K232635 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Boston Scientific. Cleared Nov 2023. https://www.510kdatabase.net/k233078/ 2023-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k233078-posterior-cervical-spine-system-fda-510k.jpg K233078 - Posterior Cervical Spine System K233078 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Double Medical Technology, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k233110/ 2023-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k233110-carnation-ambulatory-monitor-fda-510k.jpg K233110 - Carnation Ambulatory Monitor K233110 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bardy Diagnostics, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k221606/ 2023-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k221606-absorbable-cranial-flap-fixation-system-fda-510k.jpg K221606 - Absorbable Cranial Flap Fixation System K221606 is a FDA 510(k) cleared neurology medical device. Manufacturer: Chendu Medart Medical Scientific Co., Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k222511/ 2023-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k222511-oxy2pro-fda-510k.jpg K222511 - Oxy2Pro K222511 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Southmedic, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k223615/ 2023-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k223615-digital-clarusscope-system-digital-fda-510k.jpg K223615 - Digital ClarusScope System, Digital NeuroPEN System K223615 is a FDA 510(k) cleared neurology medical device. Manufacturer: Clarus Medical, LLC. Cleared Nov 2023. https://www.510kdatabase.net/k230211/ 2023-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k230211-cranioxpand-fda-510k.jpg K230211 - CranioXpand K230211 is a FDA 510(k) cleared neurology medical device. Manufacturer: KLS-Martin L.P.. Cleared Nov 2023. https://www.510kdatabase.net/k230287/ 2023-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k230287-savisafe-safety-device-fda-510k.jpg K230287 - SaviSafe Safety Device K230287 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Suzhou Savicred Biotechnology Co., Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k230641/ 2023-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k230641-ultrasonic-scaler-tips-fda-510k.jpg K230641 - Ultrasonic Scaler Tips K230641 is a FDA 510(k) cleared dental medical device. Manufacturer: Guilin Refine Medical Instrument Co., Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k230773/ 2023-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k230773-endoscopy-irrigation-tubing-fda-510k.jpg K230773 - Endoscopy Irrigation Tubing K230773 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Zhejiang Chuangxiang Medical Technology Co., Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k230834/ 2023-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k230834-cardipia-ecg-model-cardipia400h-fda-510k.jpg K230834 - CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H K230834 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Trismed Co., Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k231443/ 2023-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k231443-mini-osteo-pedicle-fixation-system-fda-510k.jpg K231443 - Mini-OSTEO Pedicle Fixation System K231443 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteomed Ind?stria E Com?rcio DE Implantes Ltda. Cleared Nov 2023. https://www.510kdatabase.net/k231975/ 2023-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k231975-pnk-total-knee-system-fda-510k.jpg K231975 - PNK Total Knee System K231975 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tjc Life Co., Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k232001/ 2023-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k232001-nu-skin-renuspa-io-fda-510k.jpg K232001 - Nu Skin RenuSpa iO K232001 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nse Products, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k232388/ 2023-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k232388-high-pressure-tubing-fda-510k.jpg K232388 - High Pressure Tubing K232388 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ningbo Dizegens Medical Science Co.,Ltd. Cleared Nov 2023. https://www.510kdatabase.net/k232496/ 2023-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k232496-brainomix-360-triage-stroke-fda-510k.jpg K232496 - Brainomix 360 Triage Stroke K232496 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainomix Limited. Cleared Nov 2023. https://www.510kdatabase.net/k232546/ 2023-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k232546-meta-g-ucla-abutment-fda-510k.jpg K232546 - Meta G UCLA Abutment K232546 is a FDA 510(k) cleared dental medical device. Manufacturer: Cowellmedi Co., Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k232549/ 2023-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k232549-nemocast-fda-510k.jpg K232549 - NemoCast K232549 is a FDA 510(k) cleared dental medical device. Manufacturer: Software Nemotec S.L.. Cleared Nov 2023. https://www.510kdatabase.net/k232573/ 2023-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k232573-infiniti-ambi-angiographic-catheter-fda-510k.jpg K232573 - INFINITI™ Ambi Angiographic Catheter K232573 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis US Corp. Cleared Nov 2023. https://www.510kdatabase.net/k232576/ 2023-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k232576-medical-nitrile-examination-gloves-fda-510k.jpg K232576 - Medical Nitrile Examination Gloves K232576 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Complete Sincerity Medical New Materials Co., Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k232719/ 2023-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k232719-promis-extension-rod-system-fda-510k.jpg K232719 - ProMIS Extension Rod System K232719 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Premia Spine, Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k232898/ 2023-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k232898-quantisal-oral-fluid-collection-device-fda-510k.jpg K232898 - Quantisal™ Oral Fluid Collection Device K232898 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Immunalysis Corporation. Cleared Nov 2023. https://www.510kdatabase.net/k232977/ 2023-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k232977-biophotas-celluma-contour-fda-510k.jpg K232977 - Biophotas Celluma CONTOUR K232977 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Biophotas, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k232988/ 2023-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k232988-aplio-flex-and-aplio-go-software-v20-fda-510k.jpg K232988 - Aplio flex and Aplio go Software V2.0 Diagnostic Ultrasound System K232988 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Nov 2023. https://www.510kdatabase.net/k233010/ 2023-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k233010-beagank-4t-plus-fda-510k.jpg K233010 - Beagank 4T Plus K233010 is a FDA 510(k) cleared neurology medical device. Manufacturer: Belega, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k233049/ 2023-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k233049-td-200-automated-tee-probe-disinfector-fda-510k.jpg K233049 - TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck™ Chemical Indicator K233049 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cs Medical, LLC. Cleared Nov 2023. https://www.510kdatabase.net/k233053/ 2023-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k233053-dexis-ti2-intraoral-sensor-dexis-ixs-fda-510k.jpg K233053 - DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor K233053 is a FDA 510(k) cleared radiology medical device. Manufacturer: Dental Imaging Technologies Corporation. Cleared Nov 2023. https://www.510kdatabase.net/k233084/ 2023-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k233084-peridot-pt-anterior-cervical-fda-510k.jpg K233084 - Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system K233084 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Gbs Commonwealth Co., Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k233191/ 2023-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k233191-totalti-acdf-by-sagico-fda-510k.jpg K233191 - TotalTi ACDF by SAGICO K233191 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinal Analytics & Geometrical Implant Co, LLC. Cleared Nov 2023. https://www.510kdatabase.net/k233245/ 2023-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k233245-magnetos-flex-matrix-fda-510k.jpg K233245 - MagnetOs Flex Matrix K233245 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Kuros Biosciences B.V. Cleared Nov 2023. https://www.510kdatabase.net/k233333/ 2023-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k233333-karl-storz-icg-imaging-system-karl-fda-510k.jpg K233333 - KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit K233333 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Karl Storz SE & CO. KG. Cleared Nov 2023. https://www.510kdatabase.net/k230627/ 2023-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k230627-zilia-ocular-fc-zil-10002-fda-510k.jpg K230627 - Zilia Ocular FC (ZIL-10002) K230627 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Zilia, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k230700/ 2023-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k230700-riwotrack-navigation-system-fda-510k.jpg K230700 - RIWOtrack Navigation System K230700 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Fiagon GmbH. Cleared Nov 2023. https://www.510kdatabase.net/k231498/ 2023-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k231498-traumacad-neo-fda-510k.jpg K231498 - TraumaCad Neo K231498 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab , Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k231692/ 2023-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k231692-ziehm-vision-rfd-fda-510k.jpg K231692 - Ziehm Vision RFD K231692 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ziehm Imaging GmbH. Cleared Nov 2023. https://www.510kdatabase.net/k231941/ 2023-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k231941-arietta-x10-fda-510k.jpg K231941 - ARIETTA x10 K231941 is a FDA 510(k) cleared radiology medical device. Manufacturer: Fujifilm Healthcare Americas Corporation. Cleared Nov 2023. https://www.510kdatabase.net/k232545/ 2023-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k232545-the-sensitox-b-anthracis-toxin-test-fda-510k.jpg K232545 - The SensiTox B. anthracis Toxin Test K232545 is a FDA 510(k) cleared microbiology medical device. Manufacturer: First Light Diagnostics, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k232555/ 2023-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k232555-harmony-fda-510k.jpg K232555 - Harmony K232555 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Topcon Healthcare Solutions. Cleared Nov 2023. https://www.510kdatabase.net/k232575/ 2023-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k232575-hair-removal-device-models-r2815-g-pro-fda-510k.jpg K232575 - Hair Removal Device, Model(s): R2815-G Pro, R2815-G K232575 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Jianchao Intelligent Technology Co., Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k233346/ 2023-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k233346-heinrich-single-use-non-stick-bayonet-fda-510k.jpg K233346 - Heinrich Single Use Non-Stick Bayonet Bipolar Forceps, 180mm, 0.5mm Tip with Cable (HMAL18/005) K233346 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Hg Innovations, Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k233351/ 2023-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k233351-single-use-non-stick-mcpherson-bipolar-fda-510k.jpg K233351 - Single Use Non-Stick McPherson Bipolar Forceps, 110mm, 0.5mm Tip with Cable (HNSAG-5110M) K233351 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Hg Innovations, Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k230190/ 2023-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k230190-polyver-silver-alginate-dressing-fda-510k.jpg K230190 - Polyver Silver Alginate Dressing (Prescription and OTC) K230190 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Roosin Medical Co., Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k230589/ 2023-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k230589-celox-rapid-x-ray-gauze-fda-510k.jpg K230589 - Celox Rapid X-Ray Gauze K230589 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medtrade Products , Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k230612/ 2023-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k230612-edwards-algorithm-for-measurement-of-fda-510k.jpg K230612 - Edwards Algorithm for Measurement of Blood Hemoglobin K230612 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Nov 2023. https://www.510kdatabase.net/k230954/ 2023-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k230954-samfilcon-b-custom-contact-lens-fda-510k.jpg K230954 - Samfilcon B Custom Contact Lens K230954 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Bausch & Lomb, Incorporated. Cleared Nov 2023. https://www.510kdatabase.net/k231020/ 2023-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k231020-alinity-c-tricyclic-antidepressants-fda-510k.jpg K231020 - Alinity c Tricyclic Antidepressants Reagent Kit K231020 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Microgenics Corporation. Cleared Nov 2023. https://www.510kdatabase.net/k231559/ 2023-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k231559-multi-unit-das-system-fda-510k.jpg K231559 - Multi-Unit DAS System K231559 is a FDA 510(k) cleared dental medical device. Manufacturer: Talladium Espa?a, SL. Cleared Nov 2023. https://www.510kdatabase.net/k231600/ 2023-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k231600-sendero-microcatheter-fda-510k.jpg K231600 - SENDERO Microcatheter K231600 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Okami Medical, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k232028/ 2023-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k232028-q-vision-sterile-single-use-adult-fda-510k.jpg K232028 - Q Vision Sterile Single Use Adult Flexible Gastroscope (G-100) K232028 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Iq Endoscopes Limited. Cleared Nov 2023. https://www.510kdatabase.net/k232501/ 2023-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k232501-ai-platform-aip001-fda-510k.jpg K232501 - AI Platform (AIP001) K232501 is a FDA 510(k) cleared radiology medical device. Manufacturer: Exo, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k232512/ 2023-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k232512-masimo-w1-fda-510k.jpg K232512 - Masimo W1 K232512 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Masimo Corporation. Cleared Nov 2023. https://www.510kdatabase.net/k232538/ 2023-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k232538-dual-color-nitrile-examination-gloves-fda-510k.jpg K232538 - DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL K232538 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wrp Asia Pacific Sdn. Bhd.. Cleared Nov 2023. https://www.510kdatabase.net/k232925/ 2023-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k232925-gastric-alimetry-system-fda-510k.jpg K232925 - Gastric Alimetry System K232925 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Alimetry , Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k232974/ 2023-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k232974-ekgenius-smart-system-fda-510k.jpg K232974 - EKGenius Smart System K232974 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ekgenius, LLC. Cleared Nov 2023. https://www.510kdatabase.net/k230451/ 2023-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k230451-aptima-chlamydia-trachomatis-assay-fda-510k.jpg K230451 - Aptima® Chlamydia trachomatis Assay K230451 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Hologic, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k231445/ 2023-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k231445-link-embrace-shoulder-system-reverse-fda-510k.jpg K231445 - LINK Embrace Shoulder System - Reverse Configuration K231445 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Waldemar Link GmbH & Co. KG. Cleared Nov 2023. https://www.510kdatabase.net/k231652/ 2023-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k231652-d100-kids-fda-510k.jpg K231652 - D100 KIDS K231652 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sorin Group Italia S.R.L.. Cleared Nov 2023. https://www.510kdatabase.net/k231694/ 2023-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k231694-masada-modular-spinal-fixation-system-fda-510k.jpg K231694 - MASADA Modular Spinal Fixation System K231694 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Astura Medical. Cleared Nov 2023. https://www.510kdatabase.net/k231738/ 2023-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k231738-neuwave-microwave-ablation-system-and-fda-510k.jpg K231738 - NEUWAVE™ Microwave Ablation System and Accessories K231738 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Neuwave Medical, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k232139/ 2023-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k232139-innova-vision-inifilcon-a-silicone-fda-510k.jpg K232139 - Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens K232139 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Innova Vision, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k232392/ 2023-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k232392-ct-lung-ventilation-analysis-software-fda-510k.jpg K232392 - CT Lung Ventilation Analysis Software (CT:V) K232392 is a FDA 510(k) cleared radiology medical device. Manufacturer: 4Dmedical Limited. Cleared Nov 2023. https://www.510kdatabase.net/k232521/ 2023-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k232521-exactechgps-total-ankle-application-fda-510k.jpg K232521 - ExactechGPS® Total Ankle Application K232521 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Blue Ortho. Cleared Nov 2023. https://www.510kdatabase.net/k232533/ 2023-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k232533-rosa-partial-knee-system-fda-510k.jpg K232533 - ROSA Partial Knee System K232533 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthosoft D/B/A Zimmer Cas. Cleared Nov 2023. https://www.510kdatabase.net/k232753/ 2023-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k232753-expd-4343d-fda-510k.jpg K232753 - EXPD 4343D K232753 is a FDA 510(k) cleared radiology medical device. Manufacturer: DRTECH Corporation. Cleared Nov 2023. https://www.510kdatabase.net/k232921/ 2023-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k232921-dailies-total1-fda-510k.jpg K232921 - DAILIES TOTAL1® K232921 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Alcon Laboratories, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k232945/ 2023-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k232945-trio-ct-triple-lumen-catheter-w-curved-fda-510k.jpg K232945 - Trio-CT­® Triple Lumen Catheter w/ Curved Extensions K232945 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medical Components, Inc. (dba MedComp). Cleared Nov 2023. https://www.510kdatabase.net/k233200/ 2023-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k233200-xplus-35-series-xplus-35-xplus-35fd-fda-510k.jpg K233200 - XPLUS 35 Series (XPLUS 35, XPLUS 35FD) K233200 is a FDA 510(k) cleared radiology medical device. Manufacturer: GEMSS HEALTHCARE CO., LTD.. Cleared Nov 2023. https://www.510kdatabase.net/k233302/ 2023-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k233302-ossiofiber-compression-staple-fda-510k.jpg K233302 - OSSIOfiber® Compression Staple K233302 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OSSIO , Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k233443/ 2023-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k233443-vital-navigation-system-fda-510k.jpg K233443 - Vital™ Navigation System K233443 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimvie Spine (Zimmer Biomet Spine, Inc.). Cleared Nov 2023. https://www.510kdatabase.net/k223414/ 2023-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k223414-curing-light-model-maxcure-9-fda-510k.jpg K223414 - Curing Light, Model: MaxCure 9 K223414 is a FDA 510(k) cleared dental medical device. Manufacturer: Guilin Refine Medical Instrument Co., Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k230463/ 2023-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k230463-nsite-scoliosis-assessment-app-fda-510k.jpg K230463 - NSite Scoliosis Assessment App K230463 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Nsite, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k231012/ 2023-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k231012-coolseal-trinity-fda-510k.jpg K231012 - CoolSeal Trinity K231012 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bolder Surgical, LLC. Cleared Nov 2023. https://www.510kdatabase.net/k231818/ 2023-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k231818-metic-airway-balloon-catheter-fda-510k.jpg K231818 - METIC™- Airway Balloon Catheter K231818 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: M/S Meril Life Sciences Pvt. , Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k231852/ 2023-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k231852-binkiert-fda-510k.jpg K231852 - BinkieRT K231852 is a FDA 510(k) cleared radiology medical device. Manufacturer: Papricalab. Cleared Nov 2023. https://www.510kdatabase.net/k232841/ 2023-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k232841-axial3d-insight-fda-510k.jpg K232841 - Axial3D Insight K232841 is a FDA 510(k) cleared radiology medical device. Manufacturer: Axial Medical Printing Limited. Cleared Nov 2023. https://www.510kdatabase.net/k232973/ 2023-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k232973-arthrex-knee-fibertak-button-suture-fda-510k.jpg K232973 - Arthrex Knee FiberTak® Button Suture Anchor K232973 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/den200070/ 2023-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/den200070-simple-2-test-fda-510k.jpg DEN200070 - Simple 2 Test DEN200070 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Letsgetchecked Inc. (Formerly Privapath Diagnostics Inc.). Cleared Nov 2023. https://www.510kdatabase.net/k230856/ 2023-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k230856-brainspec-core-software-fda-510k.jpg K230856 - BrainSpec Core™ Software K230856 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainspec, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k230878/ 2023-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k230878-qscout-lab-fda-510k.jpg K230878 - QScout Lab K230878 is a FDA 510(k) cleared hematology medical device. Manufacturer: Ad Astra Diagnostics, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k231097/ 2023-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k231097-inclusive-titanium-abutments-fda-510k.jpg K231097 - Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss® ProActive® Standard, MIS® SEVEN®, Zimmer® Eztetic® Implant Systems K231097 is a FDA 510(k) cleared dental medical device. Manufacturer: Prismatik Dentalcraft, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k231521/ 2023-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k231521-broncho-videoscope-system-fda-510k.jpg K231521 - Broncho Videoscope System K231521 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Scivita Medical Technology Co., Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k231554/ 2023-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k231554-unipearls-embolic-microspheres-fda-510k.jpg K231554 - UniPearls® Embolic Microspheres K231554 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Suzhou Haowei Medical Technology Co., Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k231783/ 2023-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k231783-vitropro-fda-510k.jpg K231783 - VitroPRO K231783 is a FDA 510(k) cleared radiology medical device. Manufacturer: CIVCO Medical Instruments Co., Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k232050/ 2023-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k232050-saremco-print-bridgetec-fda-510k.jpg K232050 - saremco print BRIDGETEC K232050 is a FDA 510(k) cleared dental medical device. Manufacturer: Saremco Dental AG. Cleared Nov 2023. https://www.510kdatabase.net/k232092/ 2023-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k232092-great-basin-toxigenic-c-difficile-fda-510k.jpg K232092 - Great Basin Toxigenic C. difficile Direct Test (CDF2) K232092 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Vela Operations USA. Cleared Nov 2023. https://www.510kdatabase.net/k232461/ 2023-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k232461-powder-free-nitrile-examination-glove-fda-510k.jpg K232461 - Powder Free Nitrile Examination Glove, Pink Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate K232461 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Kossan International Sdn Bhd. Cleared Nov 2023. https://www.510kdatabase.net/k232494/ 2023-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k232494-magnetom-avanto-fit-fda-510k.jpg K232494 - MAGNETOM Avanto fit K232494 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k232656/ 2023-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k232656-blu-totale-model-eneob852-fda-510k.jpg K232656 - BLU TOTALE (Model: ENEOB852) K232656 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Premier North America, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k232845/ 2023-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k232845-ipl-cooling-hair-removal-device-fda-510k.jpg K232845 - IPL Cooling Hair Removal Device K232845 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Siken 3D Technology Development Co., Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k233434/ 2023-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k233434-silent-nite-sleep-appliance-with-the-fda-510k.jpg K233434 - Silent Nite® Sleep Appliance with the Glidewell Hinge™ (SNGLHG) K233434 is a FDA 510(k) cleared dental medical device. Manufacturer: Prismatik Dentalcraft, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k233468/ 2023-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k233468-iconix-anchor-fda-510k.jpg K233468 - Iconix Anchor K233468 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Riverpoint Medical. Cleared Nov 2023. https://www.510kdatabase.net/k230831/ 2023-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k230831-inhance-shoulder-system-convertible-fda-510k.jpg K230831 - INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid K230831 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Ireland UC. Cleared Nov 2023. https://www.510kdatabase.net/k230849/ 2023-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k230849-ellavi-ubt-fda-510k.jpg K230849 - ELLAVI UBT K230849 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Sinapi Biomedical (Pty) , Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k231118/ 2023-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k231118-cystoscope-system-fda-510k.jpg K231118 - Cystoscope System K231118 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Shenzhen HugeMed Medical Technical Development Co., Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k231937/ 2023-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k231937-foundation-dermal-regeneration-fda-510k.jpg K231937 - Foundation Dermal Regeneration Scaffold (DRS) Solo K231937 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bionova Medical, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k232083/ 2023-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k232083-briefcase-quantification-fda-510k.jpg K232083 - BriefCase-Quantification K232083 is a FDA 510(k) cleared radiology medical device. Manufacturer: Aidoc Medical , Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k232240/ 2023-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k232240-microwave-ablation-system-bd-gt-fda-510k.jpg K232240 - Microwave Ablation System (BD-GT) K232240 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Betters(Suzhou) Medical Co., Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k232241/ 2023-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k232241-disposable-microwave-ablation-needle-t-fda-510k.jpg K232241 - Disposable Microwave Ablation Needle (T-1408, T-1410, T-1608, T-1610, L-1815, L-1818, L-2015, L-2018) K232241 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Betters(Suzhou) Medical Co., Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k232257/ 2023-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k232257-clarius-bladder-ai-fda-510k.jpg K232257 - Clarius Bladder AI K232257 is a FDA 510(k) cleared radiology medical device. Manufacturer: Clarius Mobile Health Corp.. Cleared Nov 2023. https://www.510kdatabase.net/k232488/ 2023-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k232488-accu-chek-safe-t-pro-plus-lancing-device-fda-510k.jpg K232488 - Accu-Chek Safe-T-Pro Plus Lancing Device K232488 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Roche Diabetes Care, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k232509/ 2023-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k232509-accu-chek-safe-t-pro-uno-lancing-device-fda-510k.jpg K232509 - Accu-Chek Safe-T-Pro Uno Lancing Device K232509 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Roche Diabetes Care, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k231564/ 2023-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k231564-skin-and-wound-cleanser-fda-510k.jpg K231564 - Skin and Wound Cleanser K231564 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Winner Medical Co., Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k222780/ 2023-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k222780-lily-extension-tube-and-needleless-fda-510k.jpg K222780 - LILY Extension Tube and Needleless Connector K222780 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Lily Medical Corporation. Cleared Nov 2023. https://www.510kdatabase.net/k223682/ 2023-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k223682-sirius-pintuition-seed-sirius-fda-510k.jpg K223682 - Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit K223682 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sirius Medical Systems B.V.. Cleared Nov 2023. https://www.510kdatabase.net/k223754/ 2023-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k223754-bravecx-fda-510k.jpg K223754 - BraveCX K223754 is a FDA 510(k) cleared radiology medical device. Manufacturer: Bering, Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k230828/ 2023-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k230828-flowflex-covid-19-antigen-home-test-fda-510k.jpg K230828 - Flowflex COVID-19 Antigen Home Test K230828 is a FDA 510(k) cleared microbiology medical device. Manufacturer: ACON Laboratories, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k230969/ 2023-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k230969-oxygen-concentrator-fda-510k.jpg K230969 - Oxygen Concentrator K230969 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Jiangsu Jumao X-Care Medical Equipment Co., Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k231150/ 2023-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k231150-cardio-p1-fda-510k.jpg K231150 - Cardio P1 K231150 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bionet Co., Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k231277/ 2023-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k231277-tissuestat-fda-510k.jpg K231277 - TissueStat K231277 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Durastat, LLC. Cleared Nov 2023. https://www.510kdatabase.net/k231366/ 2023-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k231366-neuronaute-plus-fda-510k.jpg K231366 - Neuronaute Plus K231366 is a FDA 510(k) cleared neurology medical device. Manufacturer: Bioserenity Sas. Cleared Nov 2023. https://www.510kdatabase.net/k231508/ 2023-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k231508-power-wheelchair-w5521-fda-510k.jpg K231508 - Power Wheelchair, W5521 K231508 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zhejiang Innuovo Rehabilitation Devices Co.,Ltd. Cleared Nov 2023. https://www.510kdatabase.net/k231617/ 2023-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k231617-magnetom-freemax-fda-510k.jpg K231617 - MAGNETOM Free.Max K231617 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k231724/ 2023-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k231724-flush-syringe-prefilled-09-normal-fda-510k.jpg K231724 - Flush Syringe (Prefilled 0.9% normal saline solution) K231724 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Spm Medicare Pvt. , Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k231752/ 2023-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k231752-ark-hydrocodone-assay-fda-510k.jpg K231752 - ARK Hydrocodone Assay K231752 is a FDA 510(k) cleared chemistry medical device. Manufacturer: ARK Diagnostics, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k231804/ 2023-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k231804-prime-xv-freezis-dmso-free-md-fda-510k.jpg K231804 - PRIME-XV FreezIS DMSO-Free MD K231804 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fujifilm Irvine Scientific. Cleared Nov 2023. https://www.510kdatabase.net/k231911/ 2023-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k231911-glenoid-reconstruction-system-full-fda-510k.jpg K231911 - Glenoid Reconstruction System – Full Wedge Baseplate K231911 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Nov 2023. https://www.510kdatabase.net/k231920/ 2023-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k231920-longeviti-clearfit-ots-cranial-implant-fda-510k.jpg K231920 - Longeviti ClearFit OTS Cranial Implant K231920 is a FDA 510(k) cleared neurology medical device. Manufacturer: Longeviti Neuro Solutions, LLC. Cleared Nov 2023. https://www.510kdatabase.net/k232442/ 2023-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k232442-disposable-endoscope-injection-needles-fda-510k.jpg K232442 - Disposable Endoscope Injection Needles K232442 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Zhejiang Soudon Medical Technology Co., Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k232810/ 2023-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k232810-dental-handpiece-wireless-endodontic-fda-510k.jpg K232810 - Dental Handpiece, Wireless Endodontic Handpiece, endoit K232810 is a FDA 510(k) cleared dental medical device. Manufacturer: Micro-Nx Co., Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k233366/ 2023-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k233366-symphony-oct-system-fda-510k.jpg K233366 - SYMPHONY OCT System K233366 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International SARL. Cleared Nov 2023. https://www.510kdatabase.net/k233408/ 2023-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k233408-materialise-shoulder-system-fda-510k.jpg K233408 - Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner K233408 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Materialise NV. Cleared Nov 2023. https://www.510kdatabase.net/k233596/ 2023-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k233596-varseosmile-triniq-fda-510k.jpg K233596 - VarseoSmile TriniQ K233596 is a FDA 510(k) cleared dental medical device. Manufacturer: Bego Bremer Goldschl?gerei Wilh. Herbst GmbH & Co. KG. Cleared Nov 2023. https://www.510kdatabase.net/k223739/ 2023-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k223739-vs-tabletop-tonometer-fda-510k.jpg K223739 - VS Tabletop Tonometer K223739 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Medimaging Integrated Solution, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k230400/ 2023-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k230400-cure-catheter-closed-system-fda-510k.jpg K230400 - Cure Catheter Closed System K230400 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Convatec, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k230534/ 2023-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k230534-briefcase-quantification-fda-510k.jpg K230534 - BriefCase-Quantification K230534 is a FDA 510(k) cleared radiology medical device. Manufacturer: Aidoc Medical , Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k231765/ 2023-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k231765-contour-protgai-fda-510k.jpg K231765 - Contour ProtégéAI K231765 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mim Software, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k231773/ 2023-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k231773-quantum-perfusion-blood-oxygenator-fda-510k.jpg K231773 - Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT75-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U K231773 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Qura S.R.L. Cleared Nov 2023. https://www.510kdatabase.net/k231798/ 2023-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k231798-da-vinci-sp-surgical-system-fda-510k.jpg K231798 - da Vinci SP Surgical System K231798 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k232152/ 2023-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k232152-nerivioinfinity-fda-510k.jpg K232152 - NerivioInfinity K232152 is a FDA 510(k) cleared neurology medical device. Manufacturer: Theranica Bioelectronics , Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k232886/ 2023-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k232886-infiloop-fixed-loop-uhmwpe-suture-fda-510k.jpg K232886 - INFILOOP® Fixed Loop UHMWPE Suture Titanium Button K232886 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Healthium Medtech Limited. Cleared Nov 2023. https://www.510kdatabase.net/den220091/ 2023-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/den220091-dream-sock-fda-510k.jpg DEN220091 - Dream Sock DEN220091 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Owlet Babycare, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k231155/ 2023-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k231155-biodegradable-medical-surgical-mask-fda-510k.jpg K231155 - Biodegradable Medical surgical mask K231155 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guangdong Kingfa Sci. & Tech.Co., Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k231966/ 2023-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k231966-logiq-e10-fda-510k.jpg K231966 - LOGIQ E10 K231966 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared Nov 2023. https://www.510kdatabase.net/k231989/ 2023-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k231989-logiq-e10s-logiq-fortis-fda-510k.jpg K231989 - LOGIQ E10s, LOGIQ Fortis K231989 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems Ultrasound and Primary Care Diagnostic,. Cleared Nov 2023. https://www.510kdatabase.net/k232292/ 2023-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k232292-peridot-ex-expandable-intervertebral-fda-510k.jpg K232292 - Peridot-EX Expandable Intervertebral Body Fusion System K232292 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Gbs Commonwealth Co., Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k232476/ 2023-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k232476-disposable-sphincterotome-fda-510k.jpg K232476 - Disposable Sphincterotome K232476 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Zhejiang Soudon Medical Technology Co., Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k232866/ 2023-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k232866-disposable-abdominal-trocars-bladed-fda-510k.jpg K232866 - Disposable Abdominal Trocars (Bladed Trocars, Bladeless Trocars, Optical Trocars) K232866 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Jiangsu Channel Medical Device Co., Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k233420/ 2023-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k233420-axium-detachable-coil-fda-510k.jpg K233420 - Axium Detachable Coil K233420 is a FDA 510(k) cleared neurology medical device. Manufacturer: Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular. Cleared Nov 2023. https://www.510kdatabase.net/k231316/ 2023-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k231316-aptima-trichomonas-vaginalis-assay-fda-510k.jpg K231316 - Aptima Trichomonas vaginalis Assay K231316 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Hologic, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k231470/ 2023-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k231470-lunit-insight-dbt-fda-510k.jpg K231470 - Lunit INSIGHT DBT K231470 is a FDA 510(k) cleared radiology medical device. Manufacturer: Lunit, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k231519/ 2023-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k231519-revital-cady-fda-510k.jpg K231519 - Revital Cady K231519 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Revital Healthcare (Epz) Limited. Cleared Nov 2023. https://www.510kdatabase.net/k231865/ 2023-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k231865-mouth-guard-atg0603r-fda-510k.jpg K231865 - Mouth Guard (ATG0603R) K231865 is a FDA 510(k) cleared dental medical device. Manufacturer: Reazeal Corp. Cleared Nov 2023. https://www.510kdatabase.net/k232857/ 2023-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k232857-karl-storz-icg-imaging-system-fda-510k.jpg K232857 - KARL STORZ ICG Imaging System K232857 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Karl Storz SE & CO. KG. Cleared Nov 2023. https://www.510kdatabase.net/den220090/ 2023-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/den220090-easysep-human-bone-marrow-cd138-fda-510k.jpg DEN220090 - EasySep™ Human Bone Marrow CD138 Positive Selection Kit (100-0748) DEN220090 is a FDA 510(k) cleared pathology medical device. Manufacturer: Stemcell Technologies Canada, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k230078/ 2023-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k230078-trax-cr-total-knee-system-fda-510k.jpg K230078 - TRAX® CR Total Knee System K230078 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Amplitude. Cleared Nov 2023. https://www.510kdatabase.net/k230100/ 2023-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k230100-scizer-sc1-m410-fda-510k.jpg K230100 - SCIZER (SC1-M410) K230100 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Classys, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k230343/ 2023-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k230343-proseal-closed-system-administration-set-fda-510k.jpg K230343 - ProSeal™ Closed System Administration Set K230343 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Epic Medical Pte. , Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k230475/ 2023-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k230475-medical-video-endoscope-system-fda-510k.jpg K230475 - Medical Video Endoscope System K230475 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Huger Medical Instrument Co., Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k230481/ 2023-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k230481-evenflo-premium-double-electric-breast-fda-510k.jpg K230481 - Evenflo Premium Double Electric Breast Pump (Model 4018) K230481 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Evenflo Feeding, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k231182/ 2023-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k231182-thermogard-hq-temperature-management-fda-510k.jpg K231182 - Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Management System K231182 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Zoll Circulation, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k231254/ 2023-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k231254-griptract-gi-endoscopic-tissue-fda-510k.jpg K231254 - GripTract-GI Endoscopic Tissue Manipulator K231254 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Actuated Medical, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k231440/ 2023-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k231440-combo-electrotherapy-device-fda-510k.jpg K231440 - Combo Electrotherapy Device K231440 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Shenzhen Roundwhale Technology Co. , Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k231569/ 2023-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k231569-manaflexx-2-model-mf002-rx-mf002-otc-fda-510k.jpg K231569 - ManaFlexx 2 (model: MF002-RX, MF002-OTC) K231569 is a FDA 510(k) cleared neurology medical device. Manufacturer: Manamed, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k231586/ 2023-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k231586-endophys-blood-pressure-monitor-model-fda-510k.jpg K231586 - Endophys Blood Pressure Monitor model BPM-30 K231586 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Endophys Technologies, LLC. Cleared Nov 2023. https://www.510kdatabase.net/k231918/ 2023-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k231918-freedom60-infusion-pump-fda-510k.jpg K231918 - Freedom60 Infusion Pump K231918 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Koru Medical Systems. Cleared Nov 2023. https://www.510kdatabase.net/k231955/ 2023-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k231955-aprevo-digital-segmentation-fda-510k.jpg K231955 - aprevo® Digital Segmentation K231955 is a FDA 510(k) cleared radiology medical device. Manufacturer: Carlsmed, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k232113/ 2023-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k232113-halcyon-ethos-radiotherapy-system-fda-510k.jpg K232113 - Halcyon, Ethos Radiotherapy System K232113 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k232186/ 2023-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k232186-logiq-e-fda-510k.jpg K232186 - LOGIQ e K232186 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems Ultrasound and Primary Care Diagnostic,. Cleared Nov 2023. https://www.510kdatabase.net/k232251/ 2023-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k232251-aptus-cannulated-compression-screws-fda-510k.jpg K232251 - APTUS Cannulated Compression Screws Line Extension, APTUS K-Wire System Line Extension K232251 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medartis AG. Cleared Nov 2023. https://www.510kdatabase.net/k232266/ 2023-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k232266-powder-free-nitrile-patient-fda-510k.jpg K232266 - Powder Free Nitrile Patient Examination Gloves, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate K232266 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Better Care Plastic Technology Co., Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k232380/ 2023-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k232380-tslim-x2-insulin-pump-with-fda-510k.jpg K232380 - t:slim X2 Insulin Pump with Interoperable Technology K232380 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Tandem Diabetes Care, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k232382/ 2023-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k232382-control-iq-technology-fda-510k.jpg K232382 - Control-IQ Technology K232382 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Tandem Diabetes Care, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k232742/ 2023-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k232742-arthrex-fibertak-suture-anchor-fda-510k.jpg K232742 - Arthrex FiberTak Suture Anchor K232742 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k233428/ 2023-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k233428-easycess-aspiration-pump-fda-510k.jpg K233428 - Easycess Aspiration Pump K233428 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Guangzhou Easycess Medical Co.,Ltd. Cleared Nov 2023. https://www.510kdatabase.net/k230326/ 2023-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k230326-enfit-to-enfit-extension-sets-fda-510k.jpg K230326 - ENFit to ENFit Extension Sets K230326 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Vesco Medical. Cleared Nov 2023. https://www.510kdatabase.net/k230800/ 2023-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k230800-xvision-525-horizon-hi-300-hi-500-fda-510k.jpg K230800 - XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50 K230800 is a FDA 510(k) cleared radiology medical device. Manufacturer: GEMSS HEALTHCARE CO., LTD.. Cleared Nov 2023. https://www.510kdatabase.net/k232029/ 2023-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k232029-versawrap-nerve-protector-fda-510k.jpg K232029 - VersaWrap Nerve Protector K232029 is a FDA 510(k) cleared neurology medical device. Manufacturer: Alafair Biosciences, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k232076/ 2023-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k232076-fibercure-fda-510k.jpg K232076 - Fibercure K232076 is a FDA 510(k) cleared dental medical device. Manufacturer: Lumendo AG. Cleared Nov 2023. https://www.510kdatabase.net/k232176/ 2023-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k232176-stellar-knee-fda-510k.jpg K232176 - STELLAR Knee K232176 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Polarisar, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k232345/ 2023-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k232345-atec-posterior-navigated-disc-prep-fda-510k.jpg K232345 - ATEC Posterior Navigated Disc Prep Instruments K232345 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k232532/ 2023-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k232532-ndyag-laser-therapy-systems-fda-510k.jpg K232532 - Nd:Yag Laser Therapy Systems K232532 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Beijing Unt Technology Co., Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k232725/ 2023-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k232725-javelot-ti-suture-anchor-javelot-ti-d-fda-510k.jpg K232725 - Javelot Ti Suture Anchor, Javelot Ti-D Suture Anchor K232725 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Suzhou Endophix Co., Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k233056/ 2023-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k233056-epizact-fda-510k.jpg K233056 - EpiZact K233056 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Guidestar Medical Devices. Cleared Nov 2023. https://www.510kdatabase.net/k233062/ 2023-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k233062-biosievetm-multi-drug-urine-test-panel-fda-510k.jpg K233062 - BioSieveTM Multi-Drug Urine Test Panel K233062 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Vivachek Biotech (Hangzhou) Co., Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k233407/ 2023-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k233407-atriclip-laa-exclusion-system-with-fda-510k.jpg K233407 - AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip (LAA0) K233407 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: AtriCure, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k233518/ 2023-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k233518-base290-led-curing-light-fda-510k.jpg K233518 - BASE290 LED Curing Light K233518 is a FDA 510(k) cleared dental medical device. Manufacturer: Handpiece Headquarters. Cleared Nov 2023. https://www.510kdatabase.net/k230927/ 2023-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k230927-optimesh-multiplanar-expandable-fda-510k.jpg K230927 - OptiMesh Multiplanar Expandable Interbody Fusion System K230927 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spineology, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k231414/ 2023-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k231414-cmo8-adult-pmp-oxygenator-with-tubing-fda-510k.jpg K231414 - CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009) K231414 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Chalice Medical , Ltd.. Cleared Nov 2023. https://www.510kdatabase.net/k232730/ 2023-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k232730-aventus-thrombectomy-system-fda-510k.jpg K232730 - Aventus Thrombectomy System K232730 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inquis Medical. Cleared Nov 2023. https://www.510kdatabase.net/k232880/ 2023-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k232880-inzii-ripstop-redeployable-retrieval-fda-510k.jpg K232880 - Inzii Ripstop Redeployable Retrieval System K232880 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Applied Medical Resources Corporation. Cleared Nov 2023. https://www.510kdatabase.net/k233402/ 2023-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k233402-bard-3dmax-mesh-fda-510k.jpg K233402 - Bard 3DMax Mesh K233402 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Davol Inc., Subsidiary of C. R. Bard, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k233502/ 2023-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k233502-tera-harz-ii-fda-510k.jpg K233502 - TERA HARZ II K233502 is a FDA 510(k) cleared dental medical device. Manufacturer: Graphy, Inc.. Cleared Nov 2023. https://www.510kdatabase.net/k230083/ 2023-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k230083-safira-fda-510k.jpg K230083 - SAFIRA K230083 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medovate Limited. Cleared Oct 2023. https://www.510kdatabase.net/k230328/ 2023-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k230328-speedboat-flush-sb1-instrument-fda-510k.jpg K230328 - Speedboat Flush SB1 Instrument K230328 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Creo Medical, Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k230352/ 2023-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k230352-tornier-humeral-nail-and-tornier-long-fda-510k.jpg K230352 - Tornier Humeral Nail and Tornier Long Humeral Nail K230352 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tornier, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k230602/ 2023-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k230602-hudson-rci-turbomist-nebulizer-system-fda-510k.jpg K230602 - Hudson RCI® TurboMist™ Nebulizer System K230602 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Medline Industries, LP. Cleared Oct 2023. https://www.510kdatabase.net/k230814/ 2023-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k230814-vrnt-fda-510k.jpg K230814 - VRNT K230814 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Cognifisense, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k231238/ 2023-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k231238-ultravision2-system-fda-510k.jpg K231238 - Ultravision2™ System K231238 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Alesi Surgical, Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k231243/ 2023-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k231243-finger-clip-pulse-oximeter-fda-510k.jpg K231243 - Finger Clip Pulse Oximeter K231243 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Guangdong Genial Technology Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k231298/ 2023-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k231298-ultravision2-system-integrated-fda-510k.jpg K231298 - Ultravision2™ System Integrated Monopolar L-Hook (H/S)™ K231298 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Alesi Surgical, Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k231362/ 2023-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k231362-ocs-heart-leukocyte-depleting-filter-fda-510k.jpg K231362 - OCS Heart Leukocyte Depleting Filter K231362 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: TransMedics, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k231629/ 2023-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k231629-091-balloon-guide-catheter-fda-510k.jpg K231629 - 091 Balloon Guide Catheter K231629 is a FDA 510(k) cleared neurology medical device. Manufacturer: Eosolutions, Corp.. Cleared Oct 2023. https://www.510kdatabase.net/k231868/ 2023-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k231868-electric-wheelchair-robooter-e40-model-fda-510k.jpg K231868 - Electric Wheelchair (Robooter E40), Model name: BBR-E40-01 K231868 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Shanghai Bangbang Robotics Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k231947/ 2023-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k231947-evolution-cement-keel-fda-510k.jpg K231947 - EVOLUTION® Cement Keel K231947 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Microport Orthopedics, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k232099/ 2023-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k232099-neodent-implant-system-gm-zygomatic-fda-510k.jpg K232099 - Neodent Implant System - GM Zygomatic Implant System K232099 is a FDA 510(k) cleared dental medical device. Manufacturer: JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A.. Cleared Oct 2023. https://www.510kdatabase.net/k232294/ 2023-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k232294-hemosphere-alta-advanced-monitoring-fda-510k.jpg K232294 - HemoSphere Alta Advanced Monitoring Platform K232294 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Oct 2023. https://www.510kdatabase.net/k232310/ 2023-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k232310-sensititre-20-24-hour-haemophilus-fda-510k.jpg K232310 - Sensititre 20-24 hour Haemophilus influenzaelStreptococcus pneumoniae MIC or Breakpoint Susceptibility System with Ceftolozane-tazobactam in the dilution range of 0.03/4-64/4ug/ml K232310 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Thermo Fisher Scientific. Cleared Oct 2023. https://www.510kdatabase.net/k232318/ 2023-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k232318-victory-lumbar-plate-system-fda-510k.jpg K232318 - VICTORY™ Lumbar Plate System K232318 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k232321/ 2023-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k232321-flexcath-contour-steerable-sheath-fda-510k.jpg K232321 - FlexCath Contour™ Steerable Sheath K232321 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k233320/ 2023-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k233320-linq-ii-insertable-cardiac-monitor-lnq22-fda-510k.jpg K233320 - LINQ II™ Insertable Cardiac Monitor (LNQ22) K233320 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k230457/ 2023-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k230457-empatica-health-monitoring-platform-fda-510k.jpg K230457 - Empatica Health Monitoring Platform K230457 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Empatica S.R.L.. Cleared Oct 2023. https://www.510kdatabase.net/k230755/ 2023-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k230755-nuera-tight-rf-model-optistream-fda-510k.jpg K230755 - NuEra Tight RF Model OptiStream K230755 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bios S.R.L.. Cleared Oct 2023. https://www.510kdatabase.net/k231029/ 2023-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k231029-nitrile-exam-glove-tested-for-use-with-fda-510k.jpg K231029 - Nitrile Exam Glove, Tested For Use With Chemotherapy Drugs And Fentanyl K231029 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zhonghong Pulin Medical Products Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k231222/ 2023-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k231222-3d-optical-coherence-tomography-3d-oct-fda-510k.jpg K231222 - 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2) K231222 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Topcon Corporation. Cleared Oct 2023. https://www.510kdatabase.net/k231340/ 2023-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k231340-renova-spine-balloon-catheter-fda-510k.jpg K231340 - Renova Spine Balloon Catheter K231340 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biopsybell S.R.L.. Cleared Oct 2023. https://www.510kdatabase.net/k231378/ 2023-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k231378-exablate-model-2100v1-exablate-fda-510k.jpg K231378 - Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0 K231378 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Insightec , Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k231836/ 2023-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k231836-clarivy-cervical-ibf-system-fda-510k.jpg K231836 - ClariVy™ Cervical IBF System K231836 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Vy Spine, LLC. Cleared Oct 2023. https://www.510kdatabase.net/k231874/ 2023-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k231874-aot-t-l-abutment-fda-510k.jpg K231874 - AOT & T-L Abutment K231874 is a FDA 510(k) cleared dental medical device. Manufacturer: Truabutment, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k231965/ 2023-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k231965-voluson-expert-22-voluson-expert-20-fda-510k.jpg K231965 - Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 K231965 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared Oct 2023. https://www.510kdatabase.net/k232145/ 2023-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k232145-acuson-sequoia-diagnostic-ultrasound-fda-510k.jpg K232145 - ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System, ACUSON Origin Diagnostic Ultrasound System K232145 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k232751/ 2023-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k232751-briefcase-triage-fda-510k.jpg K232751 - BriefCase-Triage K232751 is a FDA 510(k) cleared radiology medical device. Manufacturer: Aidoc Medical , Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k232280/ 2023-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k232280-nextar-tsa-platform-fda-510k.jpg K232280 - NextAR™ TSA Platform K232280 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Oct 2023. https://www.510kdatabase.net/k230418/ 2023-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k230418-mighty-wire-guide-wire-fda-510k.jpg K230418 - Mighty Wire Guide Wire K230418 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k233270/ 2023-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k233270-acunav-crystal-ultrasound-catheter-fda-510k.jpg K233270 - AcuNav Crystal Ultrasound Catheter K233270 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k213146/ 2023-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k213146-safety-butterfly-type-blood-collection-fda-510k.jpg K213146 - Safety butterfly type blood collection needle, Butterfly type blood collection needle, Pen type blood collection needle, Safety pen K213146 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Rongye Technology Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k220493/ 2023-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k220493-plaxpot-multi-plasma-fda-510k.jpg K220493 - Plaxpot Multi Plasma K220493 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Gcs Co. Limited. Cleared Oct 2023. https://www.510kdatabase.net/k222459/ 2023-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k222459-centrix-fluorosilver-silver-diamine-fda-510k.jpg K222459 - Centrix FluoroSilver Silver Diamine Fluoride 38% K222459 is a FDA 510(k) cleared dental medical device. Manufacturer: Centrix, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k223541/ 2023-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k223541-coldhot-compression-fda-510k.jpg K223541 - Cold/Hot Compression K223541 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Jkh Health Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k230275/ 2023-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k230275-i-stat-cg8-cartridge-with-the-i-stat-1-fda-510k.jpg K230275 - i-STAT CG8+ cartridge with the i-STAT 1 System K230275 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Point of Care, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k230285/ 2023-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k230285-i-stat-cg8-cartridge-with-the-i-stat-1-fda-510k.jpg K230285 - i-STAT CG8+ cartridge with the i-STAT 1 System K230285 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Point of Care, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k230300/ 2023-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k230300-i-stat-cg8-cartridge-with-the-i-stat-1-fda-510k.jpg K230300 - i-STAT CG8+ cartridge with the i-STAT 1 System K230300 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Point of Care, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k230490/ 2023-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k230490-pmd-clean-acne-model-4004-cablue-na-fda-510k.jpg K230490 - PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA, 4004-LPUR-NA, 4004-CABLUE-NA-INT, 4004-GREY-INT, 4004-YELLOW-INT, 4004-PSTO-INT, 4004-LPUR-INT K230490 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Dongguan Hunter Electronic Technology Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k230826/ 2023-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k230826-modius-sleep-fda-510k.jpg K230826 - Modius Sleep K230826 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neurovalens , Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k230854/ 2023-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k230854-swiftmr-fda-510k.jpg K230854 - SwiftMR K230854 is a FDA 510(k) cleared radiology medical device. Manufacturer: Airs Medical, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k231165/ 2023-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k231165-shina-syringe-fda-510k.jpg K231165 - Shina Syringe K231165 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shina Med Corporation. Cleared Oct 2023. https://www.510kdatabase.net/k231214/ 2023-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k231214-liaison-vzv-igg-ht-liaison-control-vzv-fda-510k.jpg K231214 - LIAISON VZV IgG HT, LIAISON Control VZV IgG HT K231214 is a FDA 510(k) cleared microbiology medical device. Manufacturer: DiaSorin, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k231310/ 2023-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k231310-electronic-blood-pressure-monitor-fda-510k.jpg K231310 - Electronic Blood Pressure Monitor K231310 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Jumper Medical Equipment Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k231494/ 2023-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k231494-corelink-robotic-navigation-instruments-fda-510k.jpg K231494 - CoreLink Robotic Navigation Instruments K231494 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corelink, LLC. Cleared Oct 2023. https://www.510kdatabase.net/k231545/ 2023-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k231545-hearoae-fda-510k.jpg K231545 - hearOAE K231545 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Hearx SA (Pty) , Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k231761/ 2023-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k231761-podskan-hf-diagnostic-x-ray-system-fda-510k.jpg K231761 - PodSKAN HF Diagnostic X-ray System K231761 is a FDA 510(k) cleared radiology medical device. Manufacturer: Skanray Technologies Limited. Cleared Oct 2023. https://www.510kdatabase.net/k231908/ 2023-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k231908-45-micron-polyisoprene-condom-fda-510k.jpg K231908 - 45 Micron Polyisoprene Condom K231908 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Suretex Limited. Cleared Oct 2023. https://www.510kdatabase.net/k231934/ 2023-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k231934-gia-stapler-with-tri-staple-technology-fda-510k.jpg K231934 - GIA™ Stapler with Tri-Staple™ Technology K231934 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien. Cleared Oct 2023. https://www.510kdatabase.net/k232045/ 2023-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k232045-mevis-liver-suite-fda-510k.jpg K232045 - MeVis Liver Suite K232045 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mevis Medical Solutions AG. Cleared Oct 2023. https://www.510kdatabase.net/k232346/ 2023-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k232346-digital-expert-access-with-remote-fda-510k.jpg K232346 - Digital Expert Access with Remote Scanning K232346 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Oct 2023. https://www.510kdatabase.net/k232348/ 2023-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k232348-rigel-3dr-standalone-anterior-cervical-fda-510k.jpg K232348 - RIGEL™ 3DR Standalone Anterior Cervical Interbody Fusion System K232348 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: MiRus, LLC. Cleared Oct 2023. https://www.510kdatabase.net/k232393/ 2023-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k232393-blutube-dental-unit-water-purification-fda-510k.jpg K232393 - BluTube® Dental Unit Water Purification Cartridge (BluTube®) K232393 is a FDA 510(k) cleared dental medical device. Manufacturer: Proedge Dental Products, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k232618/ 2023-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k232618-aurora-surgiscope-system-fda-510k.jpg K232618 - Aurora Surgiscope System K232618 is a FDA 510(k) cleared neurology medical device. Manufacturer: Rebound Therapeutics Corporation. Cleared Oct 2023. https://www.510kdatabase.net/k232667/ 2023-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k232667-or3o-dual-mobility-liners-fda-510k.jpg K232667 - OR3O Dual Mobility Liners K232667 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k233090/ 2023-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k233090-deka-again-pro-family-fda-510k.jpg K233090 - DEKA AGAIN PRO family K233090 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: El.En S.P.A.. Cleared Oct 2023. https://www.510kdatabase.net/k233187/ 2023-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k233187-celerity-vaporized-vh2o2-process-fda-510k.jpg K233187 - Celerity Vaporized VH2O2 Process Indicator Adhesive Label (PCC078) K233187 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Steris. Cleared Oct 2023. https://www.510kdatabase.net/k233207/ 2023-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k233207-polaris-x-unidirectional-steerable-fda-510k.jpg K233207 - Polaris X™ Unidirectional Steerable Diagnostic Catheter K233207 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Oct 2023. https://www.510kdatabase.net/k233220/ 2023-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k233220-encor-enspirebreast-biopsy-system-fda-510k.jpg K233220 - EnCor Enspire™Breast Biopsy System (E4115, E4230) K233220 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Senorx, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k233241/ 2023-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k233241-solace-sacroiliac-fixation-system-fda-510k.jpg K233241 - SOLACE Sacroiliac Fixation System K233241 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ht Medical, LLC Dba Xenix Medical. Cleared Oct 2023. https://www.510kdatabase.net/k233292/ 2023-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k233292-isis-headboxes-isis-neurostimulator-fda-510k.jpg K233292 - ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress K233292 is a FDA 510(k) cleared neurology medical device. Manufacturer: Inomed Medizintechnik GmbH. Cleared Oct 2023. https://www.510kdatabase.net/k233318/ 2023-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k233318-axios-stent-and-electrocautery-fda-510k.jpg K233318 - AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm) K233318 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Oct 2023. https://www.510kdatabase.net/k213473/ 2023-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k213473-antimicrobial-gelling-fiber-dressing-fda-510k.jpg K213473 - Antimicrobial Gelling Fiber Dressing with PHMB K213473 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Advanced Medical Solutions, Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k230320/ 2023-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k230320-nim-standard-reinforced-emg-fda-510k.jpg K230320 - NIM Standard Reinforced EMG Endotracheal Tube K230320 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Medtronic Xomed, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k230500/ 2023-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k230500-air-compression-therapy-recovery-fda-510k.jpg K230500 - Air Compression Therapy Recovery System (model: MF-AWI, MF-AWI.LED.A-801, MF-AWI.LED.B-801, MF-AWI.OLED.A-601, MF-AWI.LED.A-601, MF-AWI.LED.B-601, MF-AWI.OLED.A-401, MF-AWI.LED.A-401, MF-AWI.LED.B-401) K230500 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Jiangsu Maxf Electric Appliance Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k230559/ 2023-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k230559-hudson-rci-disposable-humidifier-with-fda-510k.jpg K230559 - Hudson RCI® Disposable Humidifier with 4 PSI Pressure Relief Valve (3230), Hudson RCI® Disposable Humidifier with 6 PSI Pressure Relief Valve (3260) K230559 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Medline Industries, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k230662/ 2023-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k230662-nitrile-exam-glove-extended-cuff-fda-510k.jpg K230662 - Nitrile Exam Glove, Extended cuff, Tested For Use With Chemotherapy Drugs, Fentanyl Citrate, And Select Other Drugs K230662 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zhonghong Pulin Medical Products Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k231550/ 2023-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k231550-sontro-otc-hearing-aids-ai-fda-510k.jpg K231550 - Sontro® OTC Hearing Aids (AI) K231550 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Soundwave Hearing, LLC. Cleared Oct 2023. https://www.510kdatabase.net/k231579/ 2023-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k231579-molli-2-fda-510k.jpg K231579 - MOLLI 2 K231579 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Molli Surgical, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k231595/ 2023-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k231595-electric-breast-pump-fda-510k.jpg K231595 - Electric Breast Pump K231595 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shenzhen Changkun Technology Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k231685/ 2023-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k231685-te-air-diagnostic-ultrasound-system-fda-510k.jpg K231685 - TE Air Diagnostic Ultrasound System K231685 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k231737/ 2023-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k231737-anax-55-spinal-system-fda-510k.jpg K231737 - ANAX™ 5.5 Spinal System K231737 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Innosys Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k232271/ 2023-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k232271-simda-abutment-fda-510k.jpg K232271 - SIMDA abutment K232271 is a FDA 510(k) cleared dental medical device. Manufacturer: Simda Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k232500/ 2023-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k232500-lumify-diagnostic-ultrasound-system-fda-510k.jpg K232500 - Lumify Diagnostic Ultrasound System K232500 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Ultrasound. Cleared Oct 2023. https://www.510kdatabase.net/k233091/ 2023-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k233091-quantum-perfusion-centrifugal-blood-fda-510k.jpg K233091 - Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT) K233091 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Qura S.R.L. Cleared Oct 2023. https://www.510kdatabase.net/k233101/ 2023-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k233101-luja-coude-20108-male-ch18-large-fda-510k.jpg K233101 - Luja Coude (20108 Male CH18 - large packaging) K233101 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Coloplast Corp.. Cleared Oct 2023. https://www.510kdatabase.net/k233170/ 2023-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k233170-cryoice-cryosphere-cryoablation-probe-fda-510k.jpg K233170 - cryoICE cryoSPHERE+ Cryoablation Probe (CRYOSP) K233170 is a FDA 510(k) cleared neurology medical device. Manufacturer: AtriCure, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k233223/ 2023-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k233223-ogmend-implant-enhancement-system-fda-510k.jpg K233223 - OGmend® Implant Enhancement System K233223 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Woven Orthopedic Technologies. Cleared Oct 2023. https://www.510kdatabase.net/k233234/ 2023-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k233234-presson-spinal-fixation-system-fda-510k.jpg K233234 - PressON Spinal Fixation System K233234 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nexus Spine, LLC. Cleared Oct 2023. https://www.510kdatabase.net/k233417/ 2023-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k233417-alltest-fentanyl-urine-test-cassette-fda-510k.jpg K233417 - AllTest Fentanyl Urine Test Cassette K233417 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Hangzhou AllTest Biotech Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k221315/ 2023-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k221315-unidental-symphony-implant-system-fda-510k.jpg K221315 - UNIdental Symphony Implant System K221315 is a FDA 510(k) cleared dental medical device. Manufacturer: Unidental Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k221615/ 2023-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k221615-newclip-patient-matched-fda-510k.jpg K221615 - Newclip Patient-matched instrumentation non sterile PSI K221615 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Newclip Technics. Cleared Oct 2023. https://www.510kdatabase.net/k222997/ 2023-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k222997-vvr-generator-system-fda-510k.jpg K222997 - VVR Generator system K222997 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Starmed Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k230284/ 2023-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k230284-penumbra-lp-coil-system-fda-510k.jpg K230284 - Penumbra LP Coil System K230284 is a FDA 510(k) cleared neurology medical device. Manufacturer: Penumbra, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k230511/ 2023-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k230511-k3900-ultrasound-imaging-system-fda-510k.jpg K230511 - K3900 Ultrasound Imaging System K230511 is a FDA 510(k) cleared radiology medical device. Manufacturer: Maui Imaging. Cleared Oct 2023. https://www.510kdatabase.net/k230645/ 2023-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k230645-benehold-surgical-incise-drape-with-fda-510k.jpg K230645 - BeneHold™ Surgical Incise Drape with CHG antimicrobial II K230645 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Avery Dennison Medical , Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k230842/ 2023-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k230842-signalhf-im008-fda-510k.jpg K230842 - SignalHF (IM008) K230842 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Implicity, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k231069/ 2023-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k231069-perla-tl-posterior-thoraco-lumbar-fda-510k.jpg K231069 - PERLA® TL Posterior Thoraco-lumbar Fixation System K231069 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spineart SA. Cleared Oct 2023. https://www.510kdatabase.net/k231327/ 2023-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k231327-powerseal-sealer-and-divider-fda-510k.jpg K231327 - POWERSEAL Sealer and Divider K231327 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Gyrus Acmi, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k231995/ 2023-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k231995-acuityudr-fda-510k.jpg K231995 - AcuityUDR K231995 is a FDA 510(k) cleared radiology medical device. Manufacturer: Radmedix, LLC. Cleared Oct 2023. https://www.510kdatabase.net/k232235/ 2023-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k232235-magstimhorizon-30-tms-therapy-system-fda-510k.jpg K232235 - Magstim®Horizon® 3.0 TMS Therapy System K232235 is a FDA 510(k) cleared neurology medical device. Manufacturer: The Magstim Company , Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k232436/ 2023-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k232436-rapid-sdh-fda-510k.jpg K232436 - Rapid SDH K232436 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ischemaview, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k233093/ 2023-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k233093-balanced-knee-system-trimax-ps-plus-fda-510k.jpg K233093 - Balanced Knee® System TriMax PS Plus Tibial Insert K233093 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ortho Development Corporation. Cleared Oct 2023. https://www.510kdatabase.net/k233113/ 2023-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k233113-elra-electrode-7-2b11s-7-2b11l-7-2b22s-fda-510k.jpg K233113 - ELRA Electrode (7-2B11S, 7-2B11L, 7-2B22S, 7-2B22L, 7-4B18S, 7-4B18L, 7-4B33S, 7-4B33L) K233113 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Starmed Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k233147/ 2023-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k233147-pixel8-rf-fda-510k.jpg K233147 - PiXel8-RF K233147 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Rohrer Aesthetics. Cleared Oct 2023. https://www.510kdatabase.net/k233210/ 2023-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k233210-sam-cs-long-duration-ultrasound-device-fda-510k.jpg K233210 - sam CS Long Duration Ultrasound Device K233210 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: ZetrOZ Systems, LLC. Cleared Oct 2023. https://www.510kdatabase.net/k230472/ 2023-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k230472-sonopuls-190-fda-510k.jpg K230472 - Sonopuls 190 K230472 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Enraf-Nonius, B.V.. Cleared Oct 2023. https://www.510kdatabase.net/k230919/ 2023-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k230919-acumen-iq-finger-cuff-fda-510k.jpg K230919 - Acumen IQ finger cuff K230919 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Oct 2023. https://www.510kdatabase.net/k231509/ 2023-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k231509-aco-apache-ultrasound-system-fda-510k.jpg K231509 - Aco Apache Ultrasound System K231509 is a FDA 510(k) cleared radiology medical device. Manufacturer: Aco Healthcare Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k232051/ 2023-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k232051-visulas-green-fda-510k.jpg K232051 - VISULAS green K232051 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Carl Zeiss Meditec. Cleared Oct 2023. https://www.510kdatabase.net/k232086/ 2023-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k232086-spineeos-fda-510k.jpg K232086 - spineEOS K232086 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eos Imaging. Cleared Oct 2023. https://www.510kdatabase.net/k232211/ 2023-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k232211-reunion-sacroiliac-joint-fusion-system-fda-510k.jpg K232211 - REUNION Sacroiliac Joint Fusion System K232211 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Astura Medical. Cleared Oct 2023. https://www.510kdatabase.net/k232223/ 2023-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k232223-pladuo-system-fda-510k.jpg K232223 - PlaDuo System K232223 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: ShenB Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k232356/ 2023-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k232356-laser-cap-model-hat-01-fda-510k.jpg K232356 - Laser Cap, Model: Hat-01 K232356 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Hubei Yjt Technology Co.,Ltd. Cleared Oct 2023. https://www.510kdatabase.net/k232570/ 2023-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k232570-steerant-super-stiff-guidewire-fda-510k.jpg K232570 - Steerant™ Super Stiff Guidewire K232570 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Oct 2023. https://www.510kdatabase.net/k232584/ 2023-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k232584-vein360-reprocessed-visions-pv014p-rx-fda-510k.jpg K232584 - Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter K232584 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vein 360, LLC. Cleared Oct 2023. https://www.510kdatabase.net/k232586/ 2023-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k232586-rexious-spinal-fixation-system-statera-fda-510k.jpg K232586 - Rexious Spinal Fixation System, Statera™ Spinal System, Statera-M™ Spinal System K232586 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: K&J Consulting Corp.. Cleared Oct 2023. https://www.510kdatabase.net/k232638/ 2023-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k232638-filteredflo-warming-blankets-fda-510k.jpg K232638 - FilteredFlo Warming Blankets K232638 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Iob Medical, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k232683/ 2023-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k232683-knotilus-peek-knotless-anchor-fda-510k.jpg K232683 - Knotilus+ PEEK Knotless Anchor K232683 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Endoscopy. Cleared Oct 2023. https://www.510kdatabase.net/k233185/ 2023-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k233185-model-p8400-controller-for-c2dxs-fda-510k.jpg K233185 - MODEL P8400 Controller for C2DX’s Hemostatix Thermal Scalpel System K233185 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C2dx, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k233348/ 2023-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k233348-16-breast-coil-fda-510k.jpg K233348 - 16 Breast Coil K233348 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical System Nederlands B.V.. Cleared Oct 2023. https://www.510kdatabase.net/k230281/ 2023-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k230281-picoclamp-fda-510k.jpg K230281 - PICOCLAMP K230281 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Kono Seisakusho Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k230893/ 2023-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k230893-swiss-lthoclast-trilogy-fda-510k.jpg K230893 - Swiss LthoClast Trilogy K230893 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: E.M.S Electro Medical Systems S.A. Cleared Oct 2023. https://www.510kdatabase.net/k231560/ 2023-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k231560-magnetom-vida-fda-510k.jpg K231560 - MAGNETOM Vida K231560 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k231732/ 2023-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k231732-cleanseal-advanced-bipolar-vessel-fda-510k.jpg K231732 - CleanSeal Advanced Bipolar Vessel Sealer Maryland K231732 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Conmed Corporation. Cleared Oct 2023. https://www.510kdatabase.net/k231764/ 2023-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k231764-ultrasound-system-1300-fda-510k.jpg K231764 - Ultrasound System 1300 K231764 is a FDA 510(k) cleared radiology medical device. Manufacturer: Bk Medical Aps. Cleared Oct 2023. https://www.510kdatabase.net/k232143/ 2023-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k232143-applanation-tonometer-ht-5000-fda-510k.jpg K232143 - Applanation Tonometer HT-5000 K232143 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Huvitz Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k232201/ 2023-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k232201-vitek-2-ast-streptococcus-penicillin-fda-510k.jpg K232201 - VITEK 2 AST-Streptococcus Penicillin (<=0.06 - =>8 µg/mL), VITEK 2 Streptococcus Penicillin (<=0.06 - >=8 µg/mL), VITEK 2 Streptococcus Penicillin K232201 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k232205/ 2023-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k232205-vesco-q-enteral-feeding-pump-fda-510k.jpg K232205 - Vesco Q™ Enteral Feeding Pump K232205 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Vesco Medical, LLC. Cleared Oct 2023. https://www.510kdatabase.net/k232305/ 2023-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k232305-ai-rad-companion-brain-mr-fda-510k.jpg K232305 - AI-Rad Companion Brain MR K232305 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions U.S.A.. Cleared Oct 2023. https://www.510kdatabase.net/k232561/ 2023-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k232561-ripley-spinal-screw-system-by-sagico-fda-510k.jpg K232561 - Ripley Spinal Screw System by SAGICO K232561 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Sagico VA USA, LLC. Cleared Oct 2023. https://www.510kdatabase.net/k233258/ 2023-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k233258-shadow-knotless-all-suture-anchors-fda-510k.jpg K233258 - Shadow Knotless All-Suture Anchors K233258 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Responsive Arthroscopy, LLC. Cleared Oct 2023. https://www.510kdatabase.net/k232091/ 2023-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k232091-jo-coconut-hybrid-cooling-personal-fda-510k.jpg K232091 - JO Coconut Hybrid Cooling Personal Lubricant K232091 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: CC Wellness, LLC. Cleared Oct 2023. https://www.510kdatabase.net/k231539/ 2023-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k231539-preset-lite-thrombectomy-device-fda-510k.jpg K231539 - pRESET LITE Thrombectomy Device K231539 is a FDA 510(k) cleared neurology medical device. Manufacturer: Phenox Limited. Cleared Oct 2023. https://www.510kdatabase.net/k223557/ 2023-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k223557-spectralis-hraoct-and-variants-fda-510k.jpg K223557 - SPECTRALIS HRA+OCT and variants K223557 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Heidelberg Engineering GmbH. Cleared Oct 2023. https://www.510kdatabase.net/k223909/ 2023-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k223909-r2gate-lite-tm-fda-510k.jpg K223909 - R2GATE Lite TM K223909 is a FDA 510(k) cleared radiology medical device. Manufacturer: Megagen Implant Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k230209/ 2023-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k230209-sonix-health-fda-510k.jpg K230209 - Sonix Health K230209 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ontact Health Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k230983/ 2023-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k230983-unicare-k-unicare-usa-fda-510k.jpg K230983 - Unicare (K-UNICARE-USA) K230983 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Tenscare, Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k230998/ 2023-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k230998-digital-wireless-intraoral-x-ray-sensor-fda-510k.jpg K230998 - Digital Wireless Intraoral X-Ray Sensor K230998 is a FDA 510(k) cleared radiology medical device. Manufacturer: Iray Imaging Technology (Haining) Limited. Cleared Oct 2023. https://www.510kdatabase.net/k231388/ 2023-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k231388-nextdent-base-fda-510k.jpg K231388 - NextDent Base K231388 is a FDA 510(k) cleared dental medical device. Manufacturer: Vertex-Dental B.V.. Cleared Oct 2023. https://www.510kdatabase.net/k231578/ 2023-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k231578-lucitone-digital-print-denture-system-fda-510k.jpg K231578 - Lucitone Digital Print Denture System K231578 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona. Cleared Oct 2023. https://www.510kdatabase.net/k231809/ 2023-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k231809-momentum-posterior-spinal-fixation-fda-510k.jpg K231809 - Momentum® Posterior Spinal Fixation System with G21 V-STEADY Bone Cement K231809 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ulrich Medical USA. Cleared Oct 2023. https://www.510kdatabase.net/k231902/ 2023-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k231902-gammex-pi-hybrid-micro-340002055-fda-510k.jpg K231902 - GAMMEX PI Hybrid Micro (340002055) K231902 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ansell Healthcare. Cleared Oct 2023. https://www.510kdatabase.net/k232042/ 2023-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k232042-nexport-trocar-system-ts211001-fda-510k.jpg K232042 - NexPort™ Trocar System (TS211001) K232042 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Mediconcepts Technology (Shenzhen) Company Limited. Cleared Oct 2023. https://www.510kdatabase.net/k232236/ 2023-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k232236-echo-fda-510k.jpg K232236 - Echo K232236 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Quanta System Spa. Cleared Oct 2023. https://www.510kdatabase.net/k232550/ 2023-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k232550-nitrile-examination-gloves-dual-color-fda-510k.jpg K232550 - Nitrile Examination Gloves, Dual Color Black-Blue K232550 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shanxi Hongjin Plastic Technology Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k232552/ 2023-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k232552-tuxdeluxe-size-1-6100b-size-2-6101b-fda-510k.jpg K232552 - TuxDeluxe (Size 1 6100B, Size 2 6101B) K232552 is a FDA 510(k) cleared radiology medical device. Manufacturer: Tuxedo Imaging, LLC. Cleared Oct 2023. https://www.510kdatabase.net/k232922/ 2023-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k232922-pure-vu-evs-system-fda-510k.jpg K232922 - Pure-Vu EVS System K232922 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Motus GI Medical Technologies , Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k232951/ 2023-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k232951-bioshield-biopsy-valve-00711124-fda-510k.jpg K232951 - BioShield Biopsy Valve (00711124) K232951 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Steris. Cleared Oct 2023. https://www.510kdatabase.net/k233065/ 2023-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k233065-v-pro-max-2-low-temperature-fda-510k.jpg K233065 - V-PRO maX 2 Low Temperature Sterilization System K233065 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Steris. Cleared Oct 2023. https://www.510kdatabase.net/k230178/ 2023-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k230178-easyone-sky-spirometer-fda-510k.jpg K230178 - EasyOne Sky Spirometer K230178 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Ndd Medizintechnik AG. Cleared Oct 2023. https://www.510kdatabase.net/k230459/ 2023-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k230459-cc-life-21-fda-510k.jpg K230459 - C.C. Life 21 K230459 is a FDA 510(k) cleared neurology medical device. Manufacturer: 21 Equipment S.R.L.. Cleared Oct 2023. https://www.510kdatabase.net/k230476/ 2023-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k230476-oran-park-mask-fda-510k.jpg K230476 - Oran Park Mask K230476 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Resmed Pty Ltd (Registration Number: 3004604967). Cleared Oct 2023. https://www.510kdatabase.net/k230478/ 2023-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k230478-acro-composites-interbody-system-fda-510k.jpg K230478 - Acro Composites Interbody System K230478 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Acro Composites, LLC. Cleared Oct 2023. https://www.510kdatabase.net/k231381/ 2023-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k231381-xpert-xpress-mvp-fda-510k.jpg K231381 - Xpert Xpress MVP K231381 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Cepheid. Cleared Oct 2023. https://www.510kdatabase.net/k231664/ 2023-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k231664-irraflow-active-fluid-exchange-system-fda-510k.jpg K231664 - IRRAflow Active Fluid Exchange System (AFES) K231664 is a FDA 510(k) cleared neurology medical device. Manufacturer: Irras USA, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k231704/ 2023-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k231704-pro-link-pro-link-ti-barbs-cervical-fda-510k.jpg K231704 - Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System K231704 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k231749/ 2023-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k231749-radio-frequency-system-fda-510k.jpg K231749 - Radio Frequency System K231749 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhenshi Sincoheren S&T Development Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k231976/ 2023-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k231976-stealthstation-cranial-software-v315-fda-510k.jpg K231976 - StealthStation Cranial Software, v3.1.5 (9735585) K231976 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Navigation, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k232371/ 2023-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k232371-actinia-hip-stems-fda-510k.jpg K232371 - Actinia® hip stems K232371 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Implantcast GmbH. Cleared Oct 2023. https://www.510kdatabase.net/k232484/ 2023-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k232484-keylift-expandable-interlaminar-fda-510k.jpg K232484 - KeyLift™ Expandable Interlaminar Stabilization System K232484 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Flospine. Cleared Oct 2023. https://www.510kdatabase.net/k232905/ 2023-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k232905-medline-unite-reflex-nitinol-staple-kit-fda-510k.jpg K232905 - Medline UNITE® REFLEX® Nitinol Staple Kit K232905 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medline Industries, LP. Cleared Oct 2023. https://www.510kdatabase.net/k232910/ 2023-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k232910-combidiagnost-r90-fda-510k.jpg K232910 - CombiDiagnost R90 K232910 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Dmc GmbH. Cleared Oct 2023. https://www.510kdatabase.net/k230199/ 2023-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k230199-byte-aligner-system-fda-510k.jpg K230199 - Byte Aligner System K230199 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k230702/ 2023-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k230702-portable-oxygen-concentrator-model-p2-fda-510k.jpg K230702 - Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3) K230702 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Qingdao Kingon Medical Science and Technology Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k230951/ 2023-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k230951-terumo-injection-filter-needle-nf-fda-510k.jpg K230951 - Terumo Injection Filter Needle (NF-3013RBKE05M) K230951 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terumo Europe N.V.. Cleared Oct 2023. https://www.510kdatabase.net/k231225/ 2023-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k231225-econsole1-fda-510k.jpg K231225 - EConsole1 K231225 is a FDA 510(k) cleared radiology medical device. Manufacturer: DRTECH Corporation. Cleared Oct 2023. https://www.510kdatabase.net/k231395/ 2023-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k231395-inno-sla-submerged-narrow-implant-system-fda-510k.jpg K231395 - INNO SLA Submerged Narrow Implant System K231395 is a FDA 510(k) cleared dental medical device. Manufacturer: Cowellmedi Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k231781/ 2023-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k231781-optimesh-multiplanar-expandable-fda-510k.jpg K231781 - OptiMesh Multiplanar Expandable Interbody Fusion System K231781 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spineology, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k231824/ 2023-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k231824-smartbolus-calculator-fda-510k.jpg K231824 - SmartBolus Calculator K231824 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Insulet Corporation. Cleared Oct 2023. https://www.510kdatabase.net/k231826/ 2023-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k231826-omnipod-5-ace-pump-fda-510k.jpg K231826 - Omnipod 5 ACE Pump K231826 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Insulet Corporation. Cleared Oct 2023. https://www.510kdatabase.net/k231907/ 2023-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k231907-medline-safety-insulin-and-tb-syringes-fda-510k.jpg K231907 - Medline Safety Insulin and TB Syringes K231907 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, LP. Cleared Oct 2023. https://www.510kdatabase.net/k232123/ 2023-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k232123-mectalif-anterior-lag-extension-fda-510k.jpg K232123 - MectaLIF Anterior Lag Extension K232123 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Oct 2023. https://www.510kdatabase.net/k232524/ 2023-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k232524-millipede-070-aspiration-catheter-fda-510k.jpg K232524 - Millipede 070 Aspiration Catheter K232524 is a FDA 510(k) cleared neurology medical device. Manufacturer: Perfuze, Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k232897/ 2023-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k232897-arthrex-small-external-fixation-system-fda-510k.jpg K232897 - Arthrex Small External Fixation System K232897 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k232924/ 2023-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k232924-t-line-hernia-mesh-fda-510k.jpg K232924 - T-Line® Hernia Mesh K232924 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Deep Blue Medical Advances, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k222214/ 2023-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k222214-vivi-surgical-helmet-system-vivi-fda-510k.jpg K222214 - ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood) K222214 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Thi Total Healthcare Innovation GmbH. Cleared Oct 2023. https://www.510kdatabase.net/k223911/ 2023-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k223911-lumen-155-sf-fda-510k.jpg K223911 - Lumen 155-SF K223911 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Intricon Corporation. Cleared Oct 2023. https://www.510kdatabase.net/k231105/ 2023-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k231105-flexible-choledochoscope-model-cs50h-fda-510k.jpg K231105 - Flexible Choledochoscope (Model: CS50H-20EU, CS50H-20US) K231105 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Shanghai AnQing Medical Instrument Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k231477/ 2023-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k231477-infinity-centralstation-wide-infinity-fda-510k.jpg K231477 - Infinity CentralStation Wide, Infinity M300, Infinity M300+ K231477 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Draeger Medical Systems, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k231899/ 2023-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k231899-hatetracell-c-titanium-cervical-ibf-fda-510k.jpg K231899 - HAtetracell™-C Titanium Cervical IBF System K231899 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Innovasis, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k232089/ 2023-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k232089-sozo-pro-fda-510k.jpg K232089 - SOZO Pro K232089 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: ImpediMed Limited. Cleared Oct 2023. https://www.510kdatabase.net/k232151/ 2023-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k232151-dynamic-tibase-fda-510k.jpg K232151 - Dynamic TiBase K232151 is a FDA 510(k) cleared dental medical device. Manufacturer: Talladium Espa?a, SL. Cleared Oct 2023. https://www.510kdatabase.net/k232878/ 2023-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k232878-transloc-3d-fda-510k.jpg K232878 - TransLoc 3D K232878 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Foundation Fusion Solutions, LLC (Dba Cornerloc). Cleared Oct 2023. https://www.510kdatabase.net/k232903/ 2023-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k232903-legend-x-platform-fda-510k.jpg K232903 - Legend X Platform K232903 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Pollogen, Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k230104/ 2023-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k230104-anthogyr-axiom-bl-x3-implants-anthogyr-fda-510k.jpg K230104 - Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL K230104 is a FDA 510(k) cleared dental medical device. Manufacturer: Anthogyr. Cleared Oct 2023. https://www.510kdatabase.net/k230249/ 2023-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k230249-ikshana-fda-510k.jpg K230249 - Ikshana K230249 is a FDA 510(k) cleared radiology medical device. Manufacturer: Immersivetouch. Cleared Oct 2023. https://www.510kdatabase.net/k230570/ 2023-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k230570-willow-generation-3-breast-pump-fda-510k.jpg K230570 - Willow Generation 3 Breast Pump K230570 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Willow Innovations, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k231725/ 2023-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k231725-laparoscope-4ka0-4ka0r-4ka30-4ka30r-fda-510k.jpg K231725 - Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R) K231725 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Hunan Endoso Life Technology Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k232020/ 2023-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k232020-iontophoresis-electrodes-fda-510k.jpg K232020 - Iontophoresis Electrodes K232020 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Top-Rank Health Care Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k232118/ 2023-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k232118-andorate-valve-kit-fda-510k.jpg K232118 - ANDORATE® Valve Kit K232118 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ga Health Company Limited. Cleared Oct 2023. https://www.510kdatabase.net/k232128/ 2023-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k232128-infrared-thermometer-aoj-20a-fda-510k.jpg K232128 - Infrared Thermometer (AOJ-20A) K232128 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen AOJ Medical Technology Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k211676/ 2023-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k211676-motiva-flora-smoothsilk-tissue-expander-fda-510k.jpg K211676 - Motiva Flora SmoothSilk Tissue Expander K211676 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Motiva USA, LLC. Cleared Oct 2023. https://www.510kdatabase.net/k222143/ 2023-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k222143-apis-r-veris-tm-fda-510k.jpg K222143 - APIS (R), VERIS (TM) K222143 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sweetbio, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k223697/ 2023-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k223697-mri-compatibility-for-existing-fda-510k.jpg K223697 - MRI compatibility for existing BioHorizons dental implants and abutments K223697 is a FDA 510(k) cleared dental medical device. Manufacturer: BioHorizons Implant Systems, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k223863/ 2023-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k223863-bonhawa-respiratory-humidifier-fda-510k.jpg K223863 - BONHAWA Respiratory Humidifier K223863 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Telesair, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k230125/ 2023-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k230125-neuroblade-system-fda-510k.jpg K230125 - Neuroblade System K230125 is a FDA 510(k) cleared neurology medical device. Manufacturer: Clearmind Biomedical. Cleared Oct 2023. https://www.510kdatabase.net/k230370/ 2023-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k230370-spotlightspotlight-duo-with-dlir-option-fda-510k.jpg K230370 - SpotLight/SpotLight Duo (with DLIR option) K230370 is a FDA 510(k) cleared radiology medical device. Manufacturer: Arineta , Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k230440/ 2023-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k230440-xpert-xpress-cov-2-plus-fda-510k.jpg K230440 - Xpert® Xpress CoV-2 plus K230440 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Cepheid. Cleared Oct 2023. https://www.510kdatabase.net/k230495/ 2023-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k230495-serena-sleep-night-guard-fda-510k.jpg K230495 - Serena Sleep Night Guard K230495 is a FDA 510(k) cleared dental medical device. Manufacturer: Meris Investment Group. Cleared Oct 2023. https://www.510kdatabase.net/k230741/ 2023-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k230741-macro-micro-test-hcg-pregnancy-test-fda-510k.jpg K230741 - Macro & Micro-Test HCG Pregnancy Test Midstream K230741 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k231495/ 2023-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k231495-the-evolve-system-with-the-transform-fda-510k.jpg K231495 - The Evolve System with the Transform Applicator K231495 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Inmode , Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k231642/ 2023-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k231642-veuron-brain-pab3-fda-510k.jpg K231642 - Veuron-Brain-pAb3 K231642 is a FDA 510(k) cleared radiology medical device. Manufacturer: Heuron Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k231672/ 2023-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k231672-s1-fda-510k.jpg K231672 - S1 K231672 is a FDA 510(k) cleared dental medical device. Manufacturer: Medpark Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k231744/ 2023-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k231744-vylink-spinal-screw-system-fda-510k.jpg K231744 - VyLink™ Spinal Screw System K231744 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Vy Spine, LLC. Cleared Oct 2023. https://www.510kdatabase.net/k232429/ 2023-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k232429-titan-dental-design-fda-510k.jpg K232429 - Titan Dental Design K232429 is a FDA 510(k) cleared dental medical device. Manufacturer: Clearadvance, LLC. Cleared Oct 2023. https://www.510kdatabase.net/k232437/ 2023-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k232437-paragon-8f-balloon-guide-catheter-fda-510k.jpg K232437 - Paragon 8F Balloon Guide Catheter K232437 is a FDA 510(k) cleared neurology medical device. Manufacturer: Wallaby Medical. Cleared Oct 2023. https://www.510kdatabase.net/k232481/ 2023-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k232481-rigel-3dr-anterior-cervical-corpectomy-fda-510k.jpg K232481 - RIGEL™ 3DR Anterior Cervical Corpectomy System K232481 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: MiRus, LLC. Cleared Oct 2023. https://www.510kdatabase.net/k232504/ 2023-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k232504-calibrate-ccx-interbody-system-fda-510k.jpg K232504 - Calibrate CCX Interbody System K232504 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k232822/ 2023-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k232822-peridot-td-spacer-system-the-peridot-fda-510k.jpg K232822 - Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior cervical interbody fusion - ACIF (The Peridot-TD Anterior Cervical Intervertebral body fusion system) K232822 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Gbs Commonwealth Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k222222/ 2023-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k222222-artemis-artemis-tpo-artemis-mx-fda-510k.jpg K222222 - Artemis, Artemis TPO, Artemis MX K222222 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eigen. Cleared Oct 2023. https://www.510kdatabase.net/k230650/ 2023-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k230650-monopolar-electrode-surgical-instrument-fda-510k.jpg K230650 - Monopolar Electrode Surgical Instrument K230650 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Vhmed (Nantong) Co. , Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k230707/ 2023-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k230707-skypro-surgical-gown-6021-fda-510k.jpg K230707 - Skypro, Surgical Gown 6021 K230707 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Skypro Medical Supplies Company. Cleared Oct 2023. https://www.510kdatabase.net/k230717/ 2023-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k230717-exactech-vantage-total-ankle-system-fda-510k.jpg K230717 - Exactech® Vantage® Total Ankle System K230717 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k231152/ 2023-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k231152-collagen-wound-dressing-fda-510k.jpg K231152 - Collagen Wound Dressing K231152 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Winner Medical Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k231231/ 2023-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k231231-mr-safety-and-compatibility-testing-fda-510k.jpg K231231 - MR Safety and Compatibility Testing and Labeling for Paragon 28 Orthopedic Fixation Devices K231231 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paragon 28, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k231475/ 2023-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k231475-montage-qs-settable-resorbable-bone-fda-510k.jpg K231475 - MONTAGE-QS Settable, Resorbable Bone Putty K231475 is a FDA 510(k) cleared neurology medical device. Manufacturer: Orthocon, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k231486/ 2023-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k231486-stable-l-standalone-lumbar-interbody-fda-510k.jpg K231486 - Stable-L Standalone Lumbar Interbody System K231486 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nexus Spine, LLC. Cleared Oct 2023. https://www.510kdatabase.net/k231551/ 2023-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k231551-stethophone-fda-510k.jpg K231551 - Stethophone K231551 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sparrow Acoustics, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k231574/ 2023-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k231574-scenaria-view-42-fda-510k.jpg K231574 - Scenaria View 4.2 K231574 is a FDA 510(k) cleared radiology medical device. Manufacturer: Fujifilm Healthcare Americas Corporation. Cleared Oct 2023. https://www.510kdatabase.net/k231708/ 2023-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k231708-axoguard-ha-nerve-protector-agha12-fda-510k.jpg K231708 - Axoguard HA+ Nerve Protector (AGHA12) K231708 is a FDA 510(k) cleared neurology medical device. Manufacturer: Axogen Corporation. Cleared Oct 2023. https://www.510kdatabase.net/k231814/ 2023-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k231814-valvulopro-valvuloplasty-balloon-fda-510k.jpg K231814 - ValvuloPro Valvuloplasty Balloon Catheter K231814 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Dongguan TT Medical, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k232448/ 2023-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k232448-freeprint-splintmaster-fda-510k.jpg K232448 - FREEPRINT® splintmaster K232448 is a FDA 510(k) cleared dental medical device. Manufacturer: Detax GmbH. Cleared Oct 2023. https://www.510kdatabase.net/k232802/ 2023-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k232802-tmini-miniature-robotic-system-fda-510k.jpg K232802 - TMINI™ Miniature Robotic System K232802 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: THINK Surgical, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k232809/ 2023-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k232809-cross-vascular-rf-generator-and-fda-510k.jpg K232809 - Cross Vascular RF Generator and Footswitch (optional accessory) K232809 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cross Vascular, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k232838/ 2023-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k232838-monkey-ringstm-external-fixation-system-fda-510k.jpg K232838 - Monkey RingsTM External Fixation System K232838 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paragon 28, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k232852/ 2023-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k232852-cross-vascular-rf-transseptal-needle-fda-510k.jpg K232852 - Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable K232852 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cross Vascular, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k232998/ 2023-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k232998-montage-xt-settable-resorbable-fda-510k.jpg K232998 - Montage- XT Settable, Resorbable Hemostatic Bone Putty K232998 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthocon, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/den200076/ 2023-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/den200076-ori-fda-510k.jpg DEN200076 - ORi DEN200076 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Masimo Corporation. Cleared Oct 2023. https://www.510kdatabase.net/k222025/ 2023-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k222025-g4derm-g4derm-plus-synthetic-wound-fda-510k.jpg K222025 - G4Derm / G4Derm Plus Synthetic Wound Matrix K222025 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Gel4med, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k223126/ 2023-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k223126-surgiaid-collagen-wound-dressing-fda-510k.jpg K223126 - SurgiAid® Collagen Wound Dressing K223126 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Maxigen Biotech, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k230116/ 2023-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k230116-vital-spinal-fixation-system-fda-510k.jpg K230116 - Vital™ Spinal Fixation System K230116 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimvie Spine (Zimmer Biomet Spine, Inc.). Cleared Oct 2023. https://www.510kdatabase.net/k230148/ 2023-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k230148-vlab-fda-510k.jpg K230148 - Vlab K230148 is a FDA 510(k) cleared neurology medical device. Manufacturer: Dormotech Medical, Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k230220/ 2023-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k230220-neuviz-128-multi-slice-ct-scanner-system-fda-510k.jpg K230220 - NeuViz 128 Multi-Slice CT Scanner System K230220 is a FDA 510(k) cleared radiology medical device. Manufacturer: Neusoft Medical Systems Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k230618/ 2023-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k230618-megagen-dental-implant-systems-fda-510k.jpg K230618 - MegaGen Dental Implant Systems Portfolio - MR Conditional K230618 is a FDA 510(k) cleared dental medical device. Manufacturer: Megagen Implant Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k230897/ 2023-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k230897-anterion-fda-510k.jpg K230897 - Anterion K230897 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Heidelberg Engineering GmbH. Cleared Oct 2023. https://www.510kdatabase.net/k231050/ 2023-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k231050-arm-blood-pressure-monitor-fda-510k.jpg K231050 - Arm Blood Pressure Monitor K231050 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Alicn Medical (Shenzhen), Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k232070/ 2023-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k232070-biodegradable-nitrile-examination-fda-510k.jpg K232070 - Biodegradable Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Black, Green) K232070 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Better Care Plastic Technology Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k232090/ 2023-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k232090-jo-coconut-hybrid-warming-personal-fda-510k.jpg K232090 - JO Coconut Hybrid Warming Personal Lubricant K232090 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: CC Wellness, LLC. Cleared Oct 2023. https://www.510kdatabase.net/k232344/ 2023-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k232344-allia-igs-3-allia-igs-5-allia-igs-7-fda-510k.jpg K232344 - Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR K232344 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems SCS. Cleared Oct 2023. https://www.510kdatabase.net/k232460/ 2023-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k232460-disposable-electrosurgical-pencil-md1000-fda-510k.jpg K232460 - Disposable electrosurgical pencil (MD1000) K232460 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Mecun Medical Supply Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k232499/ 2023-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k232499-ipl-hair-removal-device-ls-t106-ls-fda-510k.jpg K232499 - IPL Hair Removal Device (LS-T106, LS-T107, LS-T108) K232499 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Lescolton Electrical Appliance Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k232574/ 2023-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k232574-vassallo-gt-crossing14-fda-510k.jpg K232574 - VASSALLO GT Crossing14 K232574 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Filmec Co. , Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k232578/ 2023-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k232578-vassallo-gt-018-g12-fda-510k.jpg K232578 - VASSALLO GT 018 G12 K232578 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Filmec Co. , Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k232981/ 2023-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k232981-synq-software-version-13-fda-510k.jpg K232981 - Synq Software Version 1.3 K232981 is a FDA 510(k) cleared radiology medical device. Manufacturer: Synaptive Medical, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k233233/ 2023-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k233233-emphasys-femoral-stems-fda-510k.jpg K233233 - EMPHASYS Femoral Stems K233233 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Ireland UC. Cleared Oct 2023. https://www.510kdatabase.net/k223027/ 2023-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k223027-neurotrigger-basic-ntb-fda-510k.jpg K223027 - NeuroTrigger Basic (NTB) K223027 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Neurotrigger. Cleared Oct 2023. https://www.510kdatabase.net/k230130/ 2023-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k230130-micromate-navi-fda-510k.jpg K230130 - Micromate™ Navi+ K230130 is a FDA 510(k) cleared radiology medical device. Manufacturer: Isys Medizintechnik GmbH. Cleared Oct 2023. https://www.510kdatabase.net/k230916/ 2023-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k230916-wesensor-fda-510k.jpg K230916 - WeSensor K230916 is a FDA 510(k) cleared radiology medical device. Manufacturer: Picopack, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k230961/ 2023-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k230961-zeus-spinal-system-fda-510k.jpg K230961 - Zeus Spinal System K230961 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Shanghai Sanyou Medical Co, Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k231413/ 2023-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k231413-ipd-dental-implant-abutments-fda-510k.jpg K231413 - IPD Dental Implant Abutments K231413 is a FDA 510(k) cleared dental medical device. Manufacturer: Implant Protesis Dental 2004, S.L.. Cleared Oct 2023. https://www.510kdatabase.net/k231658/ 2023-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k231658-veos-spinal-fixation-system-fda-510k.jpg K231658 - VEOS Spinal Fixation System K231658 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spineway. Cleared Oct 2023. https://www.510kdatabase.net/k232341/ 2023-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k232341-carboclear-pedicle-screw-system-fda-510k.jpg K232341 - CarboClear® Pedicle Screw System K232341 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: CarboFix Orthopedics , Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k232471/ 2023-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k232471-vy-spine-vylam-laminoplasty-system-fda-510k.jpg K232471 - Vy Spine™ VyLam™ Laminoplasty System K232471 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Vy Spine, LLC. Cleared Oct 2023. https://www.510kdatabase.net/k232775/ 2023-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k232775-id-now-influenza-a-b-2-fda-510k.jpg K232775 - ID NOW Influenza A & B 2 K232775 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Diagnostics Scarborough, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k221777/ 2023-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k221777-disposable-sterile-syringe-fda-510k.jpg K221777 - Disposable Sterile Syringe K221777 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Weihai Shengjie Medical Technology Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k223802/ 2023-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k223802-accufit-fda-510k.jpg K223802 - accufit K223802 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Mettler Electronics Corporation. Cleared Oct 2023. https://www.510kdatabase.net/k223905/ 2023-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k223905-vivio-lvedp-system-fda-510k.jpg K223905 - Vivio® LVEDP System K223905 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Avicena, LLC. Cleared Oct 2023. https://www.510kdatabase.net/k223926/ 2023-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k223926-versavue-single-use-flexible-fda-510k.jpg K223926 - VersaVue Single-Use Flexible Cystoscope, VersaVue Tablet, and VersaVue Video Box K223926 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medimaging Integrated Solution, Inc (Miis). Cleared Oct 2023. https://www.510kdatabase.net/k230091/ 2023-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k230091-the-cover-fda-510k.jpg K230091 - THE Cover K230091 is a FDA 510(k) cleared dental medical device. Manufacturer: Purgo Biologics, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k230144/ 2023-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k230144-dentiai-detect-fda-510k.jpg K230144 - Denti.AI Detect K230144 is a FDA 510(k) cleared radiology medical device. Manufacturer: Denti.Ai Technology, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k230265/ 2023-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k230265-mome-arc-wireless-ambulatory-ecg-fda-510k.jpg K230265 - MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System K230265 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Infobionic, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k230777/ 2023-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k230777-patient-examination-gloves-fda-510k.jpg K230777 - Patient Examination Gloves K230777 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3A Glove Sdn. Bhd.. Cleared Oct 2023. https://www.510kdatabase.net/k230853/ 2023-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k230853-earp-nerve-cuff-electrode-fda-510k.jpg K230853 - EARP Nerve Cuff Electrode K230853 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nvision Biomedical Technologies, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k231300/ 2023-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k231300-nutricair-enteral-syringe-with-enfit-fda-510k.jpg K231300 - Nutricair Enteral Syringe with ENFit K231300 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cair Lgl. Cleared Oct 2023. https://www.510kdatabase.net/k231603/ 2023-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k231603-standard-staple-line-reinforcement-fda-510k.jpg K231603 - Standard Staple-Line Reinforcement (SSLR23) K231603 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Standard Bariatrics, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k231863/ 2023-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k231863-probeam-360-proton-therapy-system-v20-fda-510k.jpg K231863 - ProBeam 360° Proton Therapy System v2.0 (Multiroom) K231863 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k232044/ 2023-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k232044-invictus-robotic-navigation-instruments-fda-510k.jpg K232044 - Invictus Robotic Navigation Instruments K232044 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k232046/ 2023-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k232046-kangaroo-skin-level-balloon-fda-510k.jpg K232046 - Kangaroo Skin Level Balloon Gastrostomy Kit, Kangaroo Bolus Feed Set with ENFIT Connection, Kangaroo Continuous Feed Set with ENFIT Connection K232046 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Xeridiem Medical Devices, A Spectrum Plastics Group Company. Cleared Oct 2023. https://www.510kdatabase.net/k232055/ 2023-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k232055-vial-adapter-fda-510k.jpg K232055 - Vial Adapter K232055 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shanghai Lingfu Technology Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k232056/ 2023-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k232056-ipl-hair-removal-device-models-pb1-pb2-fda-510k.jpg K232056 - IPL Hair Removal Device, Model(s): PB1, PB2, PB3, PB4, TM002 K232056 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Dongguan Lide Electric Appliance Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k232173/ 2023-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k232173-ascend-vbr-system-ascend-nanotec-vbr-fda-510k.jpg K232173 - Ascend VBR System, Ascend NanoTec VBR System K232173 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k232276/ 2023-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k232276-thermo-scientific-oxoid-fda-510k.jpg K232276 - Thermo Scientific Oxoid Sulbactam/Durlobactam Disc (10/10 µg) SUD20 K232276 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Oxoid Limited (Part of Thermo Fisher Scientific). Cleared Oct 2023. https://www.510kdatabase.net/k232407/ 2023-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k232407-cautery-protective-actuation-system-cpas-fda-510k.jpg K232407 - Cautery Protective Actuation System (CPAS) K232407 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Safer Surgeries Medical Devices, LLC. Cleared Oct 2023. https://www.510kdatabase.net/k232411/ 2023-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k232411-juggerknot-soft-anchor-oc-fda-510k.jpg K232411 - JuggerKnot Soft Anchor OC K232411 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Riverpoint Medical, LLC. Cleared Oct 2023. https://www.510kdatabase.net/k232480/ 2023-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k232480-protekduo-veno-venous-cannula-sets-fda-510k.jpg K232480 - ProtekDuo Veno-Venous Cannula Sets K232480 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cardiacassist, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k232492/ 2023-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k232492-27-mm-gryphon-flex-knotless-peek-anchor-fda-510k.jpg K232492 - 2.7 mm GRYPHON™ Flex Knotless PEEK Anchor K232492 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International SARL. Cleared Oct 2023. https://www.510kdatabase.net/k232755/ 2023-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k232755-arthrex-fibertape-and-tigertape-fda-510k.jpg K232755 - Arthrex FiberTape and TigerTape Cerclage Sutures K232755 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k232760/ 2023-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k232760-swoop-portable-mr-imaging-system-fda-510k.jpg K232760 - Swoop® Portable MR Imaging System® K232760 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hyperfine, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k232787/ 2023-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k232787-scannav-anatomy-peripheral-nerve-block-fda-510k.jpg K232787 - ScanNav Anatomy Peripheral Nerve Block K232787 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Intelligent Ultrasound Limited. Cleared Oct 2023. https://www.510kdatabase.net/den220087/ 2023-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/den220087-edison-system-fda-510k.jpg DEN220087 - Edison System DEN220087 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: HistoSonics, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k220451/ 2023-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k220451-evidence-multistat-doa-urine-multiplex-fda-510k.jpg K220451 - Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT K220451 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Randox Laboratories Limited. Cleared Oct 2023. https://www.510kdatabase.net/k221550/ 2023-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k221550-evidence-multistat-doa-urine-multiplex-fda-510k.jpg K221550 - Evidence MultiSTAT DOA Urine MultiPlex K221550 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Randox Laboratories Limited. Cleared Oct 2023. https://www.510kdatabase.net/k223740/ 2023-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k223740-oxygen-concentrator-model-ksw-5-ksn-5-fda-510k.jpg K223740 - Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5) K223740 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Jiangsu Konsung Bio-Medical Science and Technology Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k230070/ 2023-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k230070-mesoram-hypodermic-needle-710301-fda-510k.jpg K230070 - MESORAM® Hypodermic Needle (710301) K230070 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Promamedical, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k230242/ 2023-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k230242-osteocentric-dental-implant-system-fda-510k.jpg K230242 - OsteoCentric Dental Implant System K230242 is a FDA 510(k) cleared dental medical device. Manufacturer: OsteoCentric Technologies. Cleared Oct 2023. https://www.510kdatabase.net/k230780/ 2023-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k230780-mfg-05-fda-510k.jpg K230780 - MFG-05 K230780 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Zimmer Medizinsysteme GmbH. Cleared Oct 2023. https://www.510kdatabase.net/k231001/ 2023-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k231001-deeptek-cxr-analyzer-v10-fda-510k.jpg K231001 - DeepTek CXR Analyzer v1.0 K231001 is a FDA 510(k) cleared radiology medical device. Manufacturer: Deeptek Medical Imaging Pvt, Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k231078/ 2023-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k231078-all-suture-anchor-fda-510k.jpg K231078 - All-Suture Anchor K231078 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Riverpoint Medical, LLC. Cleared Oct 2023. https://www.510kdatabase.net/k232279/ 2023-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k232279-lifestyles-nrl-textured-condom-fda-510k.jpg K232279 - LifeStyles NRL Textured Condom K232279 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Suretex Limited. Cleared Oct 2023. https://www.510kdatabase.net/k232367/ 2023-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k232367-cmangio-v10-fda-510k.jpg K232367 - cmAngio® V1.0 K232367 is a FDA 510(k) cleared radiology medical device. Manufacturer: Curemetrix, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k232395/ 2023-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k232395-etest-sulbactamdurlobactam-sud-00044-fda-510k.jpg K232395 - ETEST® Sulbactam/Durlobactam (SUD) (0.004/4-64/4 µg/mL), ETEST® SUD K232395 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Biom?rieux. Cleared Oct 2023. https://www.510kdatabase.net/k232675/ 2023-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k232675-heating-tens-ft-615-fda-510k.jpg K232675 - Heating Tens, FT-615 K232675 is a FDA 510(k) cleared neurology medical device. Manufacturer: Hivox Biotek, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k232704/ 2023-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k232704-clarius-ultrasound-scanner-fda-510k.jpg K232704 - Clarius Ultrasound Scanner K232704 is a FDA 510(k) cleared radiology medical device. Manufacturer: Clarius Mobile Health Corp.. Cleared Oct 2023. https://www.510kdatabase.net/k233044/ 2023-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k233044-tandem-mobi-insulin-pump-with-fda-510k.jpg K233044 - Tandem Mobi insulin pump with interoperable technology K233044 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Tandem Diabetes Care, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k230135/ 2023-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k230135-copioumed-chemotherapy-isolation-gown-fda-510k.jpg K230135 - Copioumed Chemotherapy Isolation Gown K230135 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Copioumed International, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k231025/ 2023-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k231025-efai-neurosuite-ct-ich-assessment-system-fda-510k.jpg K231025 - EFAI NeuroSuite CT ICH Assessment System K231025 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ever Fortune.Ai, Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k231398/ 2023-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k231398-vuno-med-deepbrain-fda-510k.jpg K231398 - VUNO Med-DeepBrain K231398 is a FDA 510(k) cleared radiology medical device. Manufacturer: Vuno, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k231567/ 2023-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k231567-biodegradable-nitrile-powder-free-fda-510k.jpg K231567 - Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and select other drugs (Blue) K231567 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Better Care Plastic Technology Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k232023/ 2023-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k232023-momentum-spine-fda-510k.jpg K232023 - Momentum Spine K232023 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Momentum Health, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k232763/ 2023-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k232763-electrode-handpieces-vct-rftv-bmdt-fda-510k.jpg K232763 - Electrode Handpieces (VCT, RFTV, BMDT series) K232763 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: RF Medical Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k232767/ 2023-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k232767-nautilus-vf-ecmo-oxygenator-fda-510k.jpg K232767 - Nautilus VF ECMO Oxygenator K232767 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Mc3, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k232844/ 2023-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k232844-the-iqooltm-system-fda-510k.jpg K232844 - The IQoolTM System K232844 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Braincool AB. Cleared Oct 2023. https://www.510kdatabase.net/den230002/ 2023-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/den230002-duragraft-fda-510k.jpg DEN230002 - DuraGraft DEN230002 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Marizyme, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k230085/ 2023-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k230085-lung-cad-fda-510k.jpg K230085 - Lung-CAD K230085 is a FDA 510(k) cleared radiology medical device. Manufacturer: Imagen Technologies, Inc.. Cleared Oct 2023. https://www.510kdatabase.net/k231772/ 2023-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k231772-v8h8-diagnostic-ultrasound-system-v7h7-fda-510k.jpg K231772 - V8/H8 Diagnostic Ultrasound System, V7/H7 Diagnostic Ultrasound System, V6/H6 Diagnostic Ultrasound System K231772 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Medison Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k231960/ 2023-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k231960-navicam-xpress-stomach-capsule-fda-510k.jpg K231960 - NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Capsule and NaviCam Tether K231960 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Anx Robotica Corporation. Cleared Oct 2023. https://www.510kdatabase.net/k232094/ 2023-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k232094-orchid-safety-release-valvetm-fda-510k.jpg K232094 - Orchid Safety Release ValveTM K232094 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Linear Health Sciences, LLC. Cleared Oct 2023. https://www.510kdatabase.net/k232230/ 2023-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k232230-yj-k1k2-wheelchair-yj-k1f-16-nde-fda-510k.jpg K232230 - YJ-K1/K2 Wheelchair (YJ-K1F 16 NDE K232230 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zhenjiang Assure Medical Equipment Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k232406/ 2023-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k232406-karl-storz-or1-scb-control-wu300-fda-510k.jpg K232406 - KARL STORZ OR1™ SCB CONTROL (WU300) K232406 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Karl Storz SE & CO. KG. Cleared Oct 2023. https://www.510kdatabase.net/k232712/ 2023-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k232712-umi-panorama-fda-510k.jpg K232712 - uMI Panorama K232712 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k232722/ 2023-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k232722-endodigital-platform-fda-510k.jpg K232722 - endo.digital Platform K232722 is a FDA 510(k) cleared chemistry medical device. Manufacturer: DreaMed Diabetes, Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k232762/ 2023-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k232762-ds-breast-coil-7ch-15t-fda-510k.jpg K232762 - dS Breast Coil 7ch 1.5T K232762 is a FDA 510(k) cleared radiology medical device. Manufacturer: Invivo Corporation (Business Trade Name: Philips). Cleared Oct 2023. https://www.510kdatabase.net/k232914/ 2023-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k232914-system-1e-liquid-chemical-sterilant-fda-510k.jpg K232914 - SYSTEM 1E Liquid Chemical Sterilant Processing System (P6500) K232914 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Oct 2023. https://www.510kdatabase.net/k232918/ 2023-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k232918-enspire-300-series-automated-endoscope-fda-510k.jpg K232918 - enspire 300 Series Automated Endoscope Reprocessor K232918 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Oct 2023. https://www.510kdatabase.net/k221972/ 2023-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k221972-warantec-custom-abutment-fda-510k.jpg K221972 - Warantec Custom Abutment K221972 is a FDA 510(k) cleared dental medical device. Manufacturer: Warantec Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k230681/ 2023-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k230681-blue-non-sterile-powder-free-nitrile-fda-510k.jpg K230681 - Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl K230681 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Central Medicare Sdn Bhd. Cleared Oct 2023. https://www.510kdatabase.net/k231520/ 2023-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k231520-tmcmf-solution-fda-510k.jpg K231520 - tmCMF Solution K231520 is a FDA 510(k) cleared dental medical device. Manufacturer: Techmah Cmf. Cleared Oct 2023. https://www.510kdatabase.net/k231716/ 2023-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k231716-osteoflo-hydroputty-fda-510k.jpg K231716 - OsteoFlo® HydroPutty™ K231716 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SurGenTec, LLC. Cleared Oct 2023. https://www.510kdatabase.net/k232064/ 2023-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k232064-powder-free-frost-nitrile-examination-fda-510k.jpg K232064 - Powder-Free Frost Nitrile Examination Gloves (Blue) (Tested for use with Chemotherapy Drugs and Fentanyl Citrate) K232064 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Isikel Manufacturing, LLC. Cleared Oct 2023. https://www.510kdatabase.net/k232359/ 2023-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k232359-surgical-face-mask-fda-510k.jpg K232359 - Surgical face mask K232359 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Kingstar Medical (Xianning) Co., Ltd.. Cleared Oct 2023. https://www.510kdatabase.net/k221890/ 2023-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k221890-elecsys-tg-ii-fda-510k.jpg K221890 - Elecsys Tg II K221890 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics. Cleared Sep 2023. https://www.510kdatabase.net/k212769/ 2023-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k212769-dynex-smartplex-mmrv-igg-assay-kit-fda-510k.jpg K212769 - DYNEX SmartPLEX MMRV IgG Assay Kit K212769 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dynex Technologies, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k213403/ 2023-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k213403-aptiva-ctd-essential-reagent-fda-510k.jpg K213403 - Aptiva CTD Essential Reagent K213403 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k220458/ 2023-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k220458-ultraflo-r-push-button-blood-fda-510k.jpg K220458 - UltraFlo-R Push Button Blood Collection Set K220458 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Innovative Medical Technologies, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k221274/ 2023-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k221274-starformer-tightwave-fda-510k.jpg K221274 - StarFormer, TightWave K221274 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fotona D.O.O.. Cleared Sep 2023. https://www.510kdatabase.net/k221359/ 2023-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k221359-acl-top-970-cl-hemosil-cl-anti-fda-510k.jpg K221359 - ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM K221359 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 2023. https://www.510kdatabase.net/k221508/ 2023-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k221508-anemocheck-home-fda-510k.jpg K221508 - AnemoCheck Home K221508 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sanguina, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k221570/ 2023-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k221570-antibacterial-bandage-fda-510k.jpg K221570 - Antibacterial bandage K221570 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Allmed Medical Products Co., Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k221900/ 2023-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k221900-stat-profile-prime-plus-analyzer-system-fda-510k.jpg K221900 - Stat Profile Prime Plus Analyzer System K221900 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Nova Biomedical Corporation. Cleared Sep 2023. https://www.510kdatabase.net/k223085/ 2023-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k223085-miris-human-milk-analyzer-hma-fda-510k.jpg K223085 - Miris Human Milk Analyzer (HMA) K223085 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miris AB. Cleared Sep 2023. https://www.510kdatabase.net/k223873/ 2023-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k223873-boppli-infant-blood-pressure-monitor-fda-510k.jpg K223873 - Boppli Infant Blood Pressure Monitor K223873 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Pyrames, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k230045/ 2023-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k230045-hipcheck-fda-510k.jpg K230045 - HipCheck K230045 is a FDA 510(k) cleared radiology medical device. Manufacturer: Stryker Corp.. Cleared Sep 2023. https://www.510kdatabase.net/k230187/ 2023-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k230187-terran-nm-101-fda-510k.jpg K230187 - Terran NM-101 K230187 is a FDA 510(k) cleared radiology medical device. Manufacturer: Terran Biosciences, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k230591/ 2023-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k230591-trileap-plating-system-fda-510k.jpg K230591 - TriLEAP Plating System K230591 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Crossroads Extremity Systems. Cleared Sep 2023. https://www.510kdatabase.net/k230847/ 2023-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k230847-chemotherapy-gloves-fda-510k.jpg K230847 - Chemotherapy Gloves K230847 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3A Glove Sdn. Bhd.. Cleared Sep 2023. https://www.510kdatabase.net/k231527/ 2023-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k231527-trialtis-navigation-enabled-instruments-fda-510k.jpg K231527 - TriALTIS Navigation Enabled Instruments K231527 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International S?rl. Cleared Sep 2023. https://www.510kdatabase.net/k231622/ 2023-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k231622-reger-nebulizer-irrigation-cannula-fda-510k.jpg K231622 - REGER Nebulizer Irrigation Cannula K231622 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Reger Medizintechnik, GmbH. Cleared Sep 2023. https://www.510kdatabase.net/k231628/ 2023-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k231628-beshape-one-device-fda-510k.jpg K231628 - BeShape One™ Device K231628 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Beshape Technologies , Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k231649/ 2023-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k231649-intraosseous-fusion-device-system-fda-510k.jpg K231649 - Intraosseous Fusion Device System K231649 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Auxano Medical, LLC. Cleared Sep 2023. https://www.510kdatabase.net/k231702/ 2023-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k231702-wiscope-digital-cystoscope-system-fda-510k.jpg K231702 - WiScope® Digital Cystoscope System, WiScope® Single-Use Digital Flexible Cystoscope, WiScope® Medical Tablet K231702 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: OTU Medical, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k231957/ 2023-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k231957-safebreak-vascular-fda-510k.jpg K231957 - SafeBreak® Vascular K231957 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Lineus Medical. Cleared Sep 2023. https://www.510kdatabase.net/k231973/ 2023-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k231973-polyisoprene-powder-free-black-colour-fda-510k.jpg K231973 - PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove K231973 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ineo Tech Sdn Bhd. Cleared Sep 2023. https://www.510kdatabase.net/k232299/ 2023-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k232299-ceraputty-fda-510k.jpg K232299 - CeraPutty K232299 is a FDA 510(k) cleared dental medical device. Manufacturer: Meta Biomed Co., Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k232647/ 2023-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k232647-microcatheter-fda-510k.jpg K232647 - Microcatheter K232647 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Surmodics,Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k232650/ 2023-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k232650-kheiron-spinal-fixation-system-fda-510k.jpg K232650 - KHEIRON® Spinal Fixation System, including patient specific K-ROD K232650 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: S.M.A.I.O. Cleared Sep 2023. https://www.510kdatabase.net/k232651/ 2023-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k232651-blazer-dx-20-bidirectional-steerable-fda-510k.jpg K232651 - BLAZER™ Dx-20 Bidirectional Steerable Diagnostic Catheter K232651 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Sep 2023. https://www.510kdatabase.net/k232669/ 2023-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k232669-tbi-fda-510k.jpg K232669 - TBI K232669 is a FDA 510(k) cleared immunology medical device. Manufacturer: Abbott Laboratories. Cleared Sep 2023. https://www.510kdatabase.net/k232690/ 2023-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k232690-amulet-steerable-delivery-sheath-fda-510k.jpg K232690 - Amulet™ Steerable Delivery Sheath K232690 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared Sep 2023. https://www.510kdatabase.net/k232701/ 2023-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k232701-guardenia-gar-1-fda-510k.jpg K232701 - Guardenia (GAR-1) K232701 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Advanced Surgical Concepts. Cleared Sep 2023. https://www.510kdatabase.net/k233257/ 2023-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k233257-3m-clarityaligners-with-quick-fda-510k.jpg K233257 - 3M™ Clarity™Aligners with Quick Attachments K233257 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company, Unitek Orthodontic Products. Cleared Sep 2023. https://www.510kdatabase.net/den210011/ 2023-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/den210011-invitae-common-hereditary-cancers-panel-fda-510k.jpg DEN210011 - Invitae Common Hereditary Cancers Panel DEN210011 is a FDA 510(k) cleared medical genetics medical device. Manufacturer: Invitae Corporation. Cleared Sep 2023. https://www.510kdatabase.net/den210056/ 2023-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/den210056-procise-ifx-fda-510k.jpg DEN210056 - Procise IFX DEN210056 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Procisedx, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/den220023/ 2023-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/den220023-procise-adl-fda-510k.jpg DEN220023 - Procise ADL DEN220023 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Procisedx, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k230865/ 2023-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k230865-pivo-pro-needle-free-blood-collection-fda-510k.jpg K230865 - PIVO™ Pro Needle-free Blood Collection Device K230865 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton Dickinson Infusion Therapy Systems, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k231013/ 2023-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k231013-dnarna-shield-safecollect-saliva-fda-510k.jpg K231013 - DNA/RNA Shield SafeCollect Saliva Collection kit K231013 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Zymo Research. Cleared Sep 2023. https://www.510kdatabase.net/k231188/ 2023-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k231188-align-radial-head-system-fda-510k.jpg K231188 - ALIGN Radial Head System K231188 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Skeletal Dynamics, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k231792/ 2023-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k231792-verisafe-safety-sterile-syringes-fda-510k.jpg K231792 - VeriSafe Safety sterile syringes K231792 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Promisemed Hangzhou Meditech Co., Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k231837/ 2023-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k231837-brainomix-360-triage-lvo-fda-510k.jpg K231837 - Brainomix 360 Triage LVO K231837 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainomix Limited. Cleared Sep 2023. https://www.510kdatabase.net/k231901/ 2023-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k231901-hakon-hakon-smart-fda-510k.jpg K231901 - Hakon, Hakon Smart K231901 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medical San Ind?stria DE Equipamentos M?dicos Ltda.. Cleared Sep 2023. https://www.510kdatabase.net/k232274/ 2023-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k232274-ipl-hair-removal-device-fda-510k.jpg K232274 - IPL hair removal device K232274 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lumenessa Corp. Cleared Sep 2023. https://www.510kdatabase.net/k232605/ 2023-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k232605-sacrix-sacroiliac-joint-fusion-device-fda-510k.jpg K232605 - Sacrix® Sacroiliac Joint Fusion Device System, Inspan® ScrewLES Fusion System, Invue® MAX™ + Invue Inset Anterior Cervical Plate System, and FacetFuse® Screw Fixation System K232605 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Lesspine Innovations. Cleared Sep 2023. https://www.510kdatabase.net/k232699/ 2023-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k232699-low-ejection-fraction-ai-ecg-algorithm-fda-510k.jpg K232699 - Low Ejection Fraction AI-ECG Algorithm K232699 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Anumana, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k233161/ 2023-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k233161-beautilink-sa-fda-510k.jpg K233161 - BeautiLink SA K233161 is a FDA 510(k) cleared dental medical device. Manufacturer: Shofu Dental Corporation. Cleared Sep 2023. https://www.510kdatabase.net/k214117/ 2023-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k214117-afinion-hba1c-afinion-2-and-alere-fda-510k.jpg K214117 - Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer K214117 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Diagnostics Technologies AS. Cleared Sep 2023. https://www.510kdatabase.net/k222638/ 2023-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k222638-xpert-xpress-gbs-genexpert-dx-system-fda-510k.jpg K222638 - Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems K222638 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Cepheid. Cleared Sep 2023. https://www.510kdatabase.net/k230563/ 2023-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k230563-evolution-hinge-knee-system-fda-510k.jpg K230563 - EVOLUTION® Hinge Knee System K230563 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Microport Orthopedics, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k230925/ 2023-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k230925-disposable-injection-needle-af-series-fda-510k.jpg K230925 - Disposable Injection Needle AF series K230925 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Alton (Shanghai) Medical Instruments Co., Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k231007/ 2023-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k231007-cedia-heroin-metabolite-6-am-assay-fda-510k.jpg K231007 - CEDIA Heroin Metabolite (6-AM) Assay K231007 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Microgenics Corporation. Cleared Sep 2023. https://www.510kdatabase.net/k231076/ 2023-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k231076-varilift-c-interbody-fusion-system-fda-510k.jpg K231076 - VariLift®-C Interbody Fusion System K231076 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wenzel Spine, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k231108/ 2023-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k231108-talon-transseptal-sheath-fda-510k.jpg K231108 - Talon Transseptal Sheath K231108 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inari Medical, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k231363/ 2023-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k231363-hantech-pre-filled-09-normal-saline-fda-510k.jpg K231363 - Hantech Pre-filled 0.9% Normal Saline Flush Syringes (Models PFS-1003, PFS-1005, PFS-1010) K231363 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hantech Medical Device Co., Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k231538/ 2023-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k231538-freedomflow-orbital-circumferential-fda-510k.jpg K231538 - FreedomFlow Orbital Circumferential Atherectomy System K231538 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cardio Flow Inc.,. Cleared Sep 2023. https://www.510kdatabase.net/k232167/ 2023-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k232167-vyspan-pct-system-fda-510k.jpg K232167 - VySpan™ PCT System K232167 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Vy Spine, LLC. Cleared Sep 2023. https://www.510kdatabase.net/k232255/ 2023-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k232255-ezsensor-xhd-fda-510k.jpg K232255 - EZSensor XHD K232255 is a FDA 510(k) cleared radiology medical device. Manufacturer: Qpix Solutions, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k232260/ 2023-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k232260-thinline-sheath-introducer-fda-510k.jpg K232260 - Thinline Sheath Introducer K232260 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inneuroco, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k232275/ 2023-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k232275-invictus-spinal-fixation-system-fda-510k.jpg K232275 - Invictus® Spinal Fixation System K232275 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k232596/ 2023-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k232596-endogi-s-path-biliary-stent-system-fda-510k.jpg K232596 - EndoGI S-Path Biliary Stent System K232596 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Endogi Medical, Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k232609/ 2023-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k232609-micro-ace-advanced-micro-access-system-fda-510k.jpg K232609 - Micro Ace™ Advanced Micro Access System K232609 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k232616/ 2023-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k232616-volta-af-xplorer-fda-510k.jpg K232616 - Volta AF-Xplorer K232616 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Volta Medical. Cleared Sep 2023. https://www.510kdatabase.net/k232668/ 2023-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k232668-cove-strip-osteocove-strip-fda-510k.jpg K232668 - Cove Strip, OsteoCove Strip K232668 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared Sep 2023. https://www.510kdatabase.net/k213517/ 2023-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k213517-access-thyroglobulin-antibody-ii-fda-510k.jpg K213517 - Access Thyroglobulin Antibody II K213517 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k220396/ 2023-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k220396-easystat-300-fda-510k.jpg K220396 - EasyStat 300 K220396 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Medica Corporation. Cleared Sep 2023. https://www.510kdatabase.net/k223496/ 2023-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k223496-inclusive-titanium-abutments-fda-510k.jpg K223496 - Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1 Implant Systems K223496 is a FDA 510(k) cleared dental medical device. Manufacturer: Prismatik Dentalcraft, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k230252/ 2023-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k230252-ofix-mis-app-fda-510k.jpg K230252 - OFIX MIS App K230252 is a FDA 510(k) cleared radiology medical device. Manufacturer: Orthofix US, LLC. Cleared Sep 2023. https://www.510kdatabase.net/k230398/ 2023-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k230398-medcad-accuplate-3dti-patient-specific-fda-510k.jpg K230398 - MedCAD® AccuPlate® 3DTi Patient-Specific Plating System K230398 is a FDA 510(k) cleared dental medical device. Manufacturer: Medcad. Cleared Sep 2023. https://www.510kdatabase.net/k230513/ 2023-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k230513-arthrex-univers-apex-optifit-humeral-fda-510k.jpg K230513 - Arthrex Univers Apex OptiFit Humeral Stem K230513 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k230884/ 2023-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k230884-avvigo-multi-modality-guidance-system-fda-510k.jpg K230884 - AVVIGO'+ Multi-Modality Guidance System K230884 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Sep 2023. https://www.510kdatabase.net/k231971/ 2023-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k231971-deka-physiq-360-fda-510k.jpg K231971 - DEKA PHYSIQ 360 K231971 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: El.En S.P.A.. Cleared Sep 2023. https://www.510kdatabase.net/k232233/ 2023-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k232233-invisalign-system-with-mandibular-fda-510k.jpg K232233 - Invisalign System with Mandibular Advancement Featuring Occlusal Blocks K232233 is a FDA 510(k) cleared dental medical device. Manufacturer: Align Technology, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k232336/ 2023-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k232336-es-series-v2-fda-510k.jpg K232336 - ES Series V2 K232336 is a FDA 510(k) cleared radiology medical device. Manufacturer: E-Scopics. Cleared Sep 2023. https://www.510kdatabase.net/k232617/ 2023-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k232617-acuson-maple-diagnostic-ultrasound-fda-510k.jpg K232617 - ACUSON Maple Diagnostic Ultrasound System, ACUSON Maple Select Diagnostic Ultrasound System K232617 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/den220026/ 2023-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/den220026-vasq-fda-510k.jpg DEN220026 - VasQ DEN220026 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Laminate Medical Technologies , Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k221052/ 2023-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k221052-self-fitting-hearing-aids-fda-510k.jpg K221052 - Self-Fitting hearing aids K221052 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Huizhou Jinghao Medical Technology Co., Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k223933/ 2023-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k223933-exactech-equinoxe-phx-fracture-system-fda-510k.jpg K223933 - Exactech Equinoxe PHx Fracture System K223933 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k230184/ 2023-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k230184-holter-ecg-and-abp-system-fda-510k.jpg K230184 - Holter ECG and ABP System K230184 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edan Instruments, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k230778/ 2023-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k230778-endocore-fda-510k.jpg K230778 - EndoCore K230778 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Praxis Medical, LLC. Cleared Sep 2023. https://www.510kdatabase.net/k230825/ 2023-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k230825-smileyscope-system-therapy-mode-fda-510k.jpg K230825 - Smileyscope System (Therapy Mode) K230825 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Smileyscope Holding, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k230857/ 2023-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k230857-tilink-p-si-joint-fusion-system-fda-510k.jpg K230857 - TiLink-P SI Joint Fusion System K230857 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SurGenTec, LLC. Cleared Sep 2023. https://www.510kdatabase.net/k231739/ 2023-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k231739-cervical-spine-truss-system-csts-fda-510k.jpg K231739 - Cervical Spine Truss System (CSTS) K231739 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 4Web Medical, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k231888/ 2023-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k231888-bd-texium-needle-free-syringe-fda-510k.jpg K231888 - BD Texium™ Needle-Free Syringe K231888 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Care Fusion. Cleared Sep 2023. https://www.510kdatabase.net/k231891/ 2023-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k231891-virtue-male-sling-system-with-alexis-fda-510k.jpg K231891 - Virtue Male Sling System with Alexis Wound Retractor Convenience Kit K231891 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Coloplast. Cleared Sep 2023. https://www.510kdatabase.net/k231928/ 2023-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k231928-efai-rtsuite-ct-hcap-segmentation-system-fda-510k.jpg K231928 - EFAI RTSUITE CT HCAP-Segmentation System K231928 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ever Fortune.Ai, Co., Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k231977/ 2023-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k231977-peach-2-peach-2-duo-peach-2-go-fda-510k.jpg K231977 - PEACH 2, PEACH 2 Duo, PEACH 2 go K231977 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Foreo, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k232097/ 2023-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k232097-identiti-alif-interbody-systems-fda-510k.jpg K232097 - IdentiTi ALIF Interbody Systems K232097 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k220265/ 2023-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k220265-advia-centaur-nt-probnpii-pbnpii-fda-510k.jpg K220265 - ADVIA Centaur® NT-proBNPII (PBNPII) K220265 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k222778/ 2023-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k222778-osstem-implant-system-fda-510k.jpg K222778 - Osstem Implant System K222778 is a FDA 510(k) cleared dental medical device. Manufacturer: Osstem Implant Co., Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k223919/ 2023-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k223919-blight-clear-evo-and-blight-restore-evo-fda-510k.jpg K223919 - B.Light Clear Evo and B.Light Restore Evo K223919 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bemer Int AG. Cleared Sep 2023. https://www.510kdatabase.net/k220179/ 2023-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k220179-high-speed-air-turbine-fda-510k.jpg K220179 - High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors K220179 is a FDA 510(k) cleared dental medical device. Manufacturer: Foshan Coxo Medical Instrument Co., Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k221817/ 2023-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k221817-alfis-vitamin-d-alfis-3-analyzer-fda-510k.jpg K221817 - ALFIS Vitamin D, ALFIS-3 Analyzer K221817 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Immunostics Inc.,. Cleared Sep 2023. https://www.510kdatabase.net/k223659/ 2023-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k223659-jazz-fda-510k.jpg K223659 - Jazz K223659 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ai Medical AG. Cleared Sep 2023. https://www.510kdatabase.net/k223921/ 2023-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k223921-access-cea-fda-510k.jpg K223921 - Access CEA K223921 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k230067/ 2023-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k230067-para-fix-external-fixation-system-fda-510k.jpg K230067 - Para-Fix External Fixation System K230067 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: New Paradigm Biomedical. Cleared Sep 2023. https://www.510kdatabase.net/k230350/ 2023-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k230350-visulas-yag-fda-510k.jpg K230350 - VISULAS yag K230350 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Carl Zeiss Meditec, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k230980/ 2023-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k230980-micromatrix-flex-fda-510k.jpg K230980 - MicroMatrix® Flex K230980 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Acell, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k231092/ 2023-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k231092-t-shape-2-fda-510k.jpg K231092 - T-SHAPE 2 K231092 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: B&M S.R.L. Marketing Nel Benessere. Cleared Sep 2023. https://www.510kdatabase.net/k231149/ 2023-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k231149-qxr-ctr-fda-510k.jpg K231149 - qXR-CTR K231149 is a FDA 510(k) cleared radiology medical device. Manufacturer: Qure.Ai Technologies. Cleared Sep 2023. https://www.510kdatabase.net/k231239/ 2023-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k231239-nexiva-closed-iv-catheter-system-with-fda-510k.jpg K231239 - Nexiva™ Closed IV Catheter System with NearPort™ IV Access K231239 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton Dickinson Infusion Therapy Systems, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k231384/ 2023-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k231384-annalise-enterprise-ctb-triage-trauma-fda-510k.jpg K231384 - Annalise Enterprise CTB Triage Trauma K231384 is a FDA 510(k) cleared radiology medical device. Manufacturer: Annalise-Ai Pty , Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k231446/ 2023-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k231446-single-use-latex-sterile-surgical-fda-510k.jpg K231446 - Single-Use Latex Sterile Surgical Gloves (SG100) K231446 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Fitone Latex Products Co., Ltd. Guangdong. Cleared Sep 2023. https://www.510kdatabase.net/k231479/ 2023-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k231479-trialtis-spine-system-fda-510k.jpg K231479 - TriALTIS Spine System K231479 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International SARL. Cleared Sep 2023. https://www.510kdatabase.net/k231730/ 2023-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k231730-femaseed-intratubal-insemination-fda-510k.jpg K231730 - FemaSeed Intratubal Insemination K231730 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Femasys, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k231767/ 2023-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k231767-annalise-enterprise-ctb-triage-trauma-fda-510k.jpg K231767 - Annalise Enterprise CTB Triage Trauma K231767 is a FDA 510(k) cleared radiology medical device. Manufacturer: Annalise-Ai Pty , Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k232183/ 2023-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k232183-ipl-hair-removal-device-models-t1-t2-fda-510k.jpg K232183 - IPL Hair Removal Device, Model(s): T1, T2, T3, T7, T10 K232183 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Koli Technology Co.,Ltd. Cleared Sep 2023. https://www.510kdatabase.net/k232193/ 2023-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k232193-electrically-power-wheelchairs-fda-510k.jpg K232193 - Electrically Power Wheelchairs (Models:YLB-W-0812-A01, YLB-W-0812-A02, YLB-W-0812-A03) K232193 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Yurob Rehabilitation Medical Co., Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k232224/ 2023-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k232224-ilet-dosing-decision-software-fda-510k.jpg K232224 - iLet® Dosing Decision Software K232224 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beta Bionics, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k232558/ 2023-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k232558-urolift-2-atc-advanced-tissue-control-fda-510k.jpg K232558 - UroLift 2 ATC Advanced Tissue Control System K232558 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Neotract, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k232571/ 2023-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k232571-cathtong-ii-picc-catheter-fda-510k.jpg K232571 - CATHTONG™ II PICC Catheter K232571 is a FDA 510(k) cleared general hospital medical device. Manufacturer: L&Z Us, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k232594/ 2023-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k232594-cathtong-ii-picc-catheter-fda-510k.jpg K232594 - CATHTONG™ II PICC Catheter K232594 is a FDA 510(k) cleared general hospital medical device. Manufacturer: L&Z Us, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k232978/ 2023-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k232978-dx-bond-v-dental-bonding-adhesive-fda-510k.jpg K232978 - DX. Bond V Dental Bonding Adhesive K232978 is a FDA 510(k) cleared dental medical device. Manufacturer: Sino-Dentex Co., Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k223214/ 2023-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k223214-powder-free-nitrile-examination-gloves-fda-510k.jpg K223214 - Powder-Free Nitrile Examination Gloves K223214 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Global Protection Corp.. Cleared Sep 2023. https://www.510kdatabase.net/k223354/ 2023-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k223354-egis-biliary-single-bare-stent-fda-510k.jpg K223354 - EGIS Biliary Single Bare Stent K223354 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: S&G Biotech, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k230102/ 2023-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k230102-smart-double-sides-wearable-breast-fda-510k.jpg K230102 - Smart double sides wearable breast pump, Electric bilateral breast pump K230102 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Huizhou Lvb Maternal and Infant Supplies Co., Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k230193/ 2023-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k230193-servator-p-plus-salf-solution-fda-510k.jpg K230193 - Servator P Plus SALF Solution K230193 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: S.A.L.F. Spa. Cleared Sep 2023. https://www.510kdatabase.net/k230226/ 2023-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k230226-integrity-si-fusion-system-fda-510k.jpg K230226 - Integrity-SI® Fusion System K230226 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OsteoCentric Technologies. Cleared Sep 2023. https://www.510kdatabase.net/k230467/ 2023-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k230467-btl-899f-fda-510k.jpg K230467 - BTL-899F K230467 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: BTL Industries, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k230767/ 2023-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k230767-pelvic-floor-muscle-stimulator-fda-510k.jpg K230767 - Pelvic Floor Muscle Stimulator K230767 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Nanjing Vishee Medical Technology Co., Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k231248/ 2023-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k231248-swan-ganz-catheters-flotrac-sensors-fda-510k.jpg K231248 - Swan-Ganz Catheters, FloTrac sensors, ClearSight finger cuffs, HemoSphere Advanced Monitoring Platform K231248 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciencess, LLC. Cleared Sep 2023. https://www.510kdatabase.net/k231401/ 2023-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k231401-polysafety-bc-polysafety-bc-adva-fda-510k.jpg K231401 - Polysafety BC, Polysafety BC Adva, Polywin Safety, Polywin Safety Adva K231401 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Poly Medicure Limited. Cleared Sep 2023. https://www.510kdatabase.net/k231678/ 2023-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k231678-overjet-periapical-radiolucency-assist-fda-510k.jpg K231678 - Overjet Periapical Radiolucency Assist K231678 is a FDA 510(k) cleared radiology medical device. Manufacturer: Overjet, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k232159/ 2023-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k232159-qevo-system-fda-510k.jpg K232159 - QEVO System K232159 is a FDA 510(k) cleared neurology medical device. Manufacturer: Carl Zeiss Meditec, AG. Cleared Sep 2023. https://www.510kdatabase.net/k232569/ 2023-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k232569-caremibrain-fda-510k.jpg K232569 - CAREMIBRAIN K232569 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Equipment For Medical Imaging, S.A.. Cleared Sep 2023. https://www.510kdatabase.net/k213987/ 2023-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k213987-architect-hsv-1-igg-architect-hsv-1-fda-510k.jpg K213987 - ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls K213987 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Biokit, S.A.. Cleared Sep 2023. https://www.510kdatabase.net/k223179/ 2023-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k223179-cholestech-ldx-system-fda-510k.jpg K223179 - Cholestech LDX ™ System K223179 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Alere San Diego, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k223421/ 2023-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k223421-medcad-accuplan-orthopedics-system-fda-510k.jpg K223421 - MedCAD AccuPlan Orthopedics System K223421 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medcad. Cleared Sep 2023. https://www.510kdatabase.net/k223913/ 2023-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k223913-socrates-aspiration-system-fda-510k.jpg K223913 - Socrates Aspiration System K223913 is a FDA 510(k) cleared neurology medical device. Manufacturer: Scientia Vascular, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k230011/ 2023-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k230011-mpact-extension-fda-510k.jpg K230011 - Mpact Extension K230011 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Sep 2023. https://www.510kdatabase.net/k230043/ 2023-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k230043-insulin-pen-needle-fda-510k.jpg K230043 - Insulin Pen Needle K230043 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k230239/ 2023-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k230239-airseal-ifs-system-fda-510k.jpg K230239 - AirSeal iFS System K230239 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Conmed Corporation. Cleared Sep 2023. https://www.510kdatabase.net/k230692/ 2023-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k230692-tulsa-pro-system-fda-510k.jpg K230692 - TULSA-PRO System K230692 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Profound Medical, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k231342/ 2023-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k231342-insufflator-opto-ifl1000-fda-510k.jpg K231342 - Insufflator (OPTO-IFL1000) K231342 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Guangdong Optomedic Technologies, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k231385/ 2023-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k231385-rology-teleradiology-platform-v1221103-fda-510k.jpg K231385 - Rology Teleradiology Platform (v.1.22.1103) K231385 is a FDA 510(k) cleared radiology medical device. Manufacturer: Rology, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k231854/ 2023-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k231854-1788-4k-camera-system-with-advanced-fda-510k.jpg K231854 - 1788 4K Camera System with Advanced Imaging Modality K231854 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker. Cleared Sep 2023. https://www.510kdatabase.net/k231894/ 2023-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k231894-led-spectrum-therapy-instrument-fda-510k.jpg K231894 - LED Spectrum therapy instrument K231894 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhenshi Sincoheren S&T Development Co., Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k232556/ 2023-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k232556-depuy-3d-additive-triflange-acetabular-fda-510k.jpg K232556 - DePuy 3D Additive TriFlange Acetabular Cup and DePuy TriFlange II Acetabular Cup System K232556 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Ireland UC. Cleared Sep 2023. https://www.510kdatabase.net/k232582/ 2023-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k232582-ambu-ascope-5-broncho-4222-sampler-set-fda-510k.jpg K232582 - Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler Set K232582 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Ambu A/S. Cleared Sep 2023. https://www.510kdatabase.net/k232583/ 2023-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k232583-catalyst-r1-reverse-shoulder-system-fda-510k.jpg K232583 - Catalyst R1 Reverse Shoulder System K232583 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Catalyst Orthoscience, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k232592/ 2023-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k232592-citrelock-duo-fda-510k.jpg K232592 - CITRELOCK® DUO K232592 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Acuitive Technologies, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k221309/ 2023-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k221309-ai100-with-shonit-fda-510k.jpg K221309 - AI100 with Shonit K221309 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigtuple Technologies Pvt. , Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k222948/ 2023-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k222948-q-distal-access-catheter-fda-510k.jpg K222948 - Q Distal Access Catheter K222948 is a FDA 510(k) cleared neurology medical device. Manufacturer: Mivi Neuroscience, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k230966/ 2023-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k230966-angiocclude-ligating-clips-fda-510k.jpg K230966 - angiOCCLUDE Ligating Clips K230966 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: A2 Medical Systems, LLC. Cleared Sep 2023. https://www.510kdatabase.net/k231106/ 2023-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k231106-accuject-refra-injector-ar2900-fda-510k.jpg K231106 - Accuject Refra Injector AR2900 K231106 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Medicel AG. Cleared Sep 2023. https://www.510kdatabase.net/k231281/ 2023-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k231281-aquilion-serve-tsx-307a1-v13-fda-510k.jpg K231281 - Aquilion Serve (TSX-307A/1) V1.3 K231281 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Sep 2023. https://www.510kdatabase.net/k231802/ 2023-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k231802-millipede-088-access-catheter-fda-510k.jpg K231802 - Millipede 088 Access Catheter K231802 is a FDA 510(k) cleared neurology medical device. Manufacturer: Perfuze, Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k232178/ 2023-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k232178-gxr-esecs-diagnostic-x-ray-system-fda-510k.jpg K232178 - GXR-ES/ECS Diagnostic X-Ray System, (Models GXR-ES series, GXR-ECS series) K232178 is a FDA 510(k) cleared radiology medical device. Manufacturer: DRGEM Corporation. Cleared Sep 2023. https://www.510kdatabase.net/k222251/ 2023-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k222251-brahms-cga-ii-kryptor-brahms-cga-ii-fda-510k.jpg K222251 - B·R·A·H·M·S CgA II KRYPTOR, B·R·A·H·M·S CgA II KRYPTOR CAL, B·R·A·H·M·S CgA II KRYPTOR QC K222251 is a FDA 510(k) cleared immunology medical device. Manufacturer: B.R.A.H.M.S GmbH, Part of Thermo Fisher. Cleared Sep 2023. https://www.510kdatabase.net/k223835/ 2023-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k223835-ma-40-ma-112-fda-510k.jpg K223835 - MA-40, MA-112 K223835 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medify Air, LLC. Cleared Sep 2023. https://www.510kdatabase.net/k231367/ 2023-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k231367-wrist-electronic-blood-pressure-fda-510k.jpg K231367 - Wrist Electronic Blood Pressure Monitor(Model FC-BP200, FC-BP201, FC-BP210,FC-BP211, FC-BP220, FC-BP221) K231367 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Finicare Co., Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k231663/ 2023-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k231663-the-aveotsd-tongue-stabilizing-device-fda-510k.jpg K231663 - The AVEOtsd (Tongue Stabilizing Device) Mouthpiece K231663 is a FDA 510(k) cleared dental medical device. Manufacturer: Innovative Health Technologies (Nz), Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k231832/ 2023-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k231832-access-myoglobin-fda-510k.jpg K231832 - Access Myoglobin K231832 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k232172/ 2023-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k232172-btl-785bnf-handpiece-fda-510k.jpg K232172 - BTL-785BNF Handpiece K232172 is a FDA 510(k) cleared neurology medical device. Manufacturer: BTL Industries, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k232513/ 2023-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k232513-x-twist-biocomposite-suture-anchor-fda-510k.jpg K232513 - X-Twist Biocomposite Suture Anchor K232513 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Parcus Medical. Cleared Sep 2023. https://www.510kdatabase.net/k232530/ 2023-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k232530-stable-l-standalone-lumbar-interbody-fda-510k.jpg K232530 - Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System K232530 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nexus Spine, LLC. Cleared Sep 2023. https://www.510kdatabase.net/k232544/ 2023-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k232544-apollo-esg-nxt-system-apollo-revise-fda-510k.jpg K232544 - Apollo ESG NXT System, Apollo REVISE NXT System K232544 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Apollo Endosurgery, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k230483/ 2023-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k230483-passy-muir-tracheostomy-viral-fda-510k.jpg K230483 - Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) K230483 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Passy-Muir, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k231688/ 2023-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k231688-impact-version-4-fda-510k.jpg K231688 - ImPACT Version 4 K231688 is a FDA 510(k) cleared neurology medical device. Manufacturer: Impact Applications, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k220735/ 2023-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k220735-avologi-gel-primer-model-av25-fda-510k.jpg K220735 - Avologi Gel Primer (Model: Av25) K220735 is a FDA 510(k) cleared neurology medical device. Manufacturer: Premier North America, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k220972/ 2023-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k220972-access-thyroglobulin-fda-510k.jpg K220972 - Access Thyroglobulin K220972 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k221860/ 2023-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k221860-plpt-ldvlow-dead-volume-lcluer-cone-fda-510k.jpg K221860 - PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLPT LDV(Low Dead Volume) LL(Luer-Lock) Sterile Syringe K221860 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Poonglim Pharmatech, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k222610/ 2023-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k222610-elecsys-anti-tg-fda-510k.jpg K222610 - Elecsys Anti-Tg K222610 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics. Cleared Sep 2023. https://www.510kdatabase.net/k223788/ 2023-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k223788-the-medsource-truesafe-blood-control-fda-510k.jpg K223788 - The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter K223788 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medsource International, LLC. Cleared Sep 2023. https://www.510kdatabase.net/k223812/ 2023-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k223812-sensis-vibe-vd15-fda-510k.jpg K223812 - Sensis Vibe (VD15) K223812 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k223857/ 2023-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k223857-i-stat-g3-cartridge-with-the-i-stat-1-fda-510k.jpg K223857 - i-STAT G3+ cartridge with the i-STAT 1 System K223857 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Point of Care, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k230066/ 2023-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k230066-carnation-series-diagnostic-ultrasound-fda-510k.jpg K230066 - Carnation series Diagnostic Ultrasound System K230066 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Wisonic Medical Technology Co. , Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k230332/ 2023-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k230332-ambu-ascope-colon-fda-510k.jpg K230332 - Ambu® aScope™ Colon K230332 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ambu A/S. Cleared Sep 2023. https://www.510kdatabase.net/k230752/ 2023-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k230752-over-tube-tr-1208a-fda-510k.jpg K230752 - Over-tube (TR-1208A) K230752 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fujifilm Healthcare Americas Corporation. Cleared Sep 2023. https://www.510kdatabase.net/k230946/ 2023-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k230946-accelerate-compression-screw-system-fda-510k.jpg K230946 - Accelerate Compression Screw System-Small Product Code ACC-S K230946 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Trax Surgical. Cleared Sep 2023. https://www.510kdatabase.net/k230974/ 2023-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k230974-nido-pedicle-screw-system-fda-510k.jpg K230974 - NIDO™ Pedicle Screw System K230974 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Kalitec Medical. Cleared Sep 2023. https://www.510kdatabase.net/k231235/ 2023-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k231235-lw-ucla-abutment-fda-510k.jpg K231235 - LW UCLA Abutment K231235 is a FDA 510(k) cleared dental medical device. Manufacturer: Ossvis Co., Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k231242/ 2023-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k231242-perifix-fx-catheter-fda-510k.jpg K231242 - Perifix FX Catheter K231242 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k231336/ 2023-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k231336-t2-biothreat-panel-fda-510k.jpg K231336 - T2 Biothreat Panel K231336 is a FDA 510(k) cleared microbiology medical device. Manufacturer: T2biosystems, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k231791/ 2023-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k231791-pento-ndyag-and-alexandrite-laser-system-fda-510k.jpg K231791 - PENTO Nd:YAG and Alexandrite laser system K231791 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ilooda Co,., Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k231827/ 2023-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k231827-bti-dental-implant-system-unicca-fda-510k.jpg K231827 - BTI Dental Implant System UnicCa® – Aesthetic Post Abutments K231827 is a FDA 510(k) cleared dental medical device. Manufacturer: B.T.I. Biotechnology Institute, Sl.. Cleared Sep 2023. https://www.510kdatabase.net/k232102/ 2023-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k232102-clearpoint-array-system-version-12-fda-510k.jpg K232102 - ClearPoint Array System (Version 1.2) K232102 is a FDA 510(k) cleared neurology medical device. Manufacturer: ClearPoint Neuro, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k232121/ 2023-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k232121-power-wheelchair-modelbc-ea8000-fda-510k.jpg K232121 - Power wheelchair (Model:BC-EA8000) K232121 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Ningbo Baichen Medical Devices Co., Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k232198/ 2023-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k232198-reclining-wheelchair-yj-011s-16d-yj-fda-510k.jpg K232198 - Reclining wheelchair (YJ-011S 16”D, YJ-011S 16”DF, YJ-011S 18”D, YJ-011S 18”DF, YJ-011S 20”D, YJ-011S 20”DF) K232198 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zhenjiang Assure Medical Equipment Co., Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k232199/ 2023-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k232199-bariatric-heavy-duty-wheelchair-yj-fda-510k.jpg K232199 - Bariatric Heavy Duty Wheelchair (YJ-010B 20’’DS K232199 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zhenjiang Assure Medical Equipment Co., Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k232315/ 2023-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k232315-catalyst-bone-void-filler-fda-510k.jpg K232315 - Catalyst Bone Void Filler K232315 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ossdsign AB. Cleared Sep 2023. https://www.510kdatabase.net/k232508/ 2023-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k232508-barrier-easywarm-active-self-warming-fda-510k.jpg K232508 - Barrier EasyWarm Active Self-Warming Blanket K232508 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Molnlycke Health Care Us, LLC. Cleared Sep 2023. https://www.510kdatabase.net/k220034/ 2023-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k220034-neuroshield-fda-510k.jpg K220034 - NEUROShield K220034 is a FDA 510(k) cleared radiology medical device. Manufacturer: In-Med Prognostics L3c. Cleared Sep 2023. https://www.510kdatabase.net/k223833/ 2023-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k223833-exactech-equinoxe-reverse-humeral-fda-510k.jpg K223833 - Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter Trays K223833 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k223869/ 2023-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k223869-choicespine-blackhawk-ti-cervical-fda-510k.jpg K223869 - ChoiceSpine Blackhawk Ti Cervical Spacer System K223869 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Choice Spine, LLC. Cleared Sep 2023. https://www.510kdatabase.net/k223885/ 2023-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k223885-hopkins-telescopes-fda-510k.jpg K223885 - HOPKINS Telescopes K223885 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k230108/ 2023-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k230108-straumann-blc-and-tlc-implants-fda-510k.jpg K230108 - Straumann® BLC and TLC Implants K230108 is a FDA 510(k) cleared dental medical device. Manufacturer: Institut Straumann AG. Cleared Sep 2023. https://www.510kdatabase.net/k230167/ 2023-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k230167-back-4-fda-510k.jpg K230167 - BACK 4 K230167 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Swims America Corp. Cleared Sep 2023. https://www.510kdatabase.net/k230237/ 2023-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k230237-dental-braces-model-hk-y-04-hk-y-045-fda-510k.jpg K230237 - Dental Braces (Model: HK-Y-0.4, HK-Y-0.45, HK-Y-0.63, HK-Y-0.7, HK-Y-ST-0.76, HK-Y-CF-0.76, HK-Y-0.9, HK-Y-1.0, HK-Y-2.0) K230237 is a FDA 510(k) cleared dental medical device. Manufacturer: Hkable 3D Biologic Printing Technology(Chongqing) Co., Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k230526/ 2023-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k230526-tea-device-fda-510k.jpg K230526 - TEA Device K230526 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Transtimulation Research, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k230746/ 2023-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k230746-non-absorbable-surgical-polypropylene-fda-510k.jpg K230746 - Non absorbable Surgical Polypropylene Suture K230746 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shandong Haidike Medical Products Co., Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k230775/ 2023-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k230775-sofia-ex-intracranial-support-catheter-fda-510k.jpg K230775 - SOFIA EX Intracranial Support Catheter K230775 is a FDA 510(k) cleared neurology medical device. Manufacturer: MicroVention, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k230959/ 2023-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k230959-vitreject-needle-fda-510k.jpg K230959 - VitreJect® Needle K230959 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ocuject, LLC. Cleared Sep 2023. https://www.510kdatabase.net/k230987/ 2023-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k230987-flowstar-analog-mixer-flowmeter-fda-510k.jpg K230987 - FlowStar Analog Mixer Flowmeter K230987 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Baldus Sedation GmbH & Co. KG. Cleared Sep 2023. https://www.510kdatabase.net/k231030/ 2023-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k231030-cove-putty-osteocove-putty-fda-510k.jpg K231030 - Cove Putty, OsteoCove Putty K231030 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared Sep 2023. https://www.510kdatabase.net/k231079/ 2023-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k231079-lw-retraction-cap-fda-510k.jpg K231079 - LW Retraction Cap K231079 is a FDA 510(k) cleared dental medical device. Manufacturer: Ossvis Co., Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k231147/ 2023-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k231147-hammerdesis-interphalangeal-fusion-fda-510k.jpg K231147 - Hammerdesis™ Interphalangeal Fusion System K231147 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Intelivation. Cleared Sep 2023. https://www.510kdatabase.net/k231353/ 2023-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k231353-accuctp-pro-fda-510k.jpg K231353 - AccuCTP Pro K231353 is a FDA 510(k) cleared radiology medical device. Manufacturer: ArteryFlow Technology Co., Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k231484/ 2023-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k231484-pureway-14-quart-sharps-collector-fda-510k.jpg K231484 - PureWay 1.4 Quart Sharps Collector K231484 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Pureway Compliance, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k231576/ 2023-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k231576-cneuro-cpet-fda-510k.jpg K231576 - cNeuro cPET K231576 is a FDA 510(k) cleared radiology medical device. Manufacturer: Combinostics OY. Cleared Sep 2023. https://www.510kdatabase.net/k232124/ 2023-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k232124-ipl-hair-removal-model-w-1095-w-1098-fda-510k.jpg K232124 - IPL Hair Removal, Model: W-1095, W-1098 K232124 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Wochuan Electronic Co., Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k232146/ 2023-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k232146-anovo-pedestal-fda-510k.jpg K232146 - Anovo Pedestal K232146 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Momentis Surgical , Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k232189/ 2023-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k232189-orionxr-fda-510k.jpg K232189 - OrionXR K232189 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hoth Intelligence, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k232462/ 2023-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k232462-thermpix-thermovisual-camera-fda-510k.jpg K232462 - ThermPix Thermovisual Camera K232462 is a FDA 510(k) cleared radiology medical device. Manufacturer: Usa Therm, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k232467/ 2023-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k232467-cleancart-a-cleancart-c-ak-98-fda-510k.jpg K232467 - CleanCart A, CleanCart C, AK 98 Hemodialysis Machine K232467 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corporation. Cleared Sep 2023. https://www.510kdatabase.net/k232487/ 2023-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k232487-provecta-3d-prime-and-provecta-3d-fda-510k.jpg K232487 - Provecta 3D Prime and Provecta 3D Prime Ceph K232487 is a FDA 510(k) cleared radiology medical device. Manufacturer: Durr Dental SE. Cleared Sep 2023. https://www.510kdatabase.net/k232827/ 2023-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k232827-lightforce-orthodontic-system-fda-510k.jpg K232827 - LightForce Orthodontic System K232827 is a FDA 510(k) cleared dental medical device. Manufacturer: Lightforce Orthodontics. Cleared Sep 2023. https://www.510kdatabase.net/k221640/ 2023-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k221640-allomap-heart-molecular-expression-fda-510k.jpg K221640 - AlloMap Heart Molecular Expression Testing K221640 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Caredx, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k222831/ 2023-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k222831-cryocheck-factor-viii-deficient-plasma-fda-510k.jpg K222831 - CRYOcheck Factor VIII Deficient Plasma with VWF K222831 is a FDA 510(k) cleared hematology medical device. Manufacturer: Precision Biologic, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k223811/ 2023-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k223811-lung-cad-fda-510k.jpg K223811 - Lung-CAD K223811 is a FDA 510(k) cleared radiology medical device. Manufacturer: Imagen Technologies, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k230609/ 2023-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k230609-ng-delivery-catheter-fda-510k.jpg K230609 - NG Delivery Catheter K230609 is a FDA 510(k) cleared neurology medical device. Manufacturer: Balt USA, LLC. Cleared Sep 2023. https://www.510kdatabase.net/k230735/ 2023-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k230735-ultimate-rtms-fda-510k.jpg K230735 - Ultimate rTMS K230735 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brain Ultimate, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k230750/ 2023-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k230750-ossiofiber-cannulated-trimmable-fda-510k.jpg K230750 - OSSIOfiber® Cannulated Trimmable Fixation Nail K230750 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OSSIO , Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k232158/ 2023-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k232158-genx-cr-fda-510k.jpg K232158 - GenX-CR K232158 is a FDA 510(k) cleared radiology medical device. Manufacturer: Genoray Co., Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k232485/ 2023-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k232485-amsco-600-steam-sterilizer-fda-510k.jpg K232485 - AMSCO 600 Steam Sterilizer K232485 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Steris. Cleared Sep 2023. https://www.510kdatabase.net/den230021/ 2023-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/den230021-ensoetm-fda-510k.jpg DEN230021 - ensoETM DEN230021 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Advanced Cooling Therapy, Inc. D/B/A Attune Medical. Cleared Sep 2023. https://www.510kdatabase.net/k213767/ 2023-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k213767-endure-etco202-nasal-cannula-fda-510k.jpg K213767 - Endure ETCO2/02 Nasal Cannula K213767 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Endure Industries, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k222938/ 2023-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k222938-ablation-fit-fda-510k.jpg K222938 - Ablation-fit K222938 is a FDA 510(k) cleared radiology medical device. Manufacturer: R.A.W. S.R.L. Cleared Sep 2023. https://www.510kdatabase.net/k230598/ 2023-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k230598-stone-extraction-baskets-fda-510k.jpg K230598 - Stone Extraction Baskets K230598 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Jiangsu Vedkang Medical Science and Technology Co., Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k231011/ 2023-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k231011-merilas-532-shortpulse-merilas-577-fda-510k.jpg K231011 - Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse K231011 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Meridian AG. Cleared Sep 2023. https://www.510kdatabase.net/k231112/ 2023-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k231112-materialise-shoulder-system-fda-510k.jpg K231112 - Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner K231112 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Materialise NV. Cleared Sep 2023. https://www.510kdatabase.net/k231317/ 2023-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k231317-truebeam-truebeam-stx-edge-vitalbeam-fda-510k.jpg K231317 - TrueBeam, TrueBeam STx, Edge, VitalBeam K231317 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k231748/ 2023-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k231748-cartesion-prime-pcd-1000a3-v1015-fda-510k.jpg K231748 - Cartesion Prime (PCD-1000A/3) V10.15 K231748 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Sep 2023. https://www.510kdatabase.net/k231766/ 2023-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k231766-skyway-anterior-cervical-plate-system-fda-510k.jpg K231766 - Skyway Anterior Cervical Plate System K231766 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Kyocera Medical Technologies Inc. (KMTI). Cleared Sep 2023. https://www.510kdatabase.net/k231892/ 2023-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k231892-definium-pace-select-fda-510k.jpg K231892 - Definium Pace Select K231892 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Hualun Medical Systems Co. , Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k232459/ 2023-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k232459-velacur-fda-510k.jpg K232459 - Velacur K232459 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sonic Incytes. Cleared Sep 2023. https://www.510kdatabase.net/k232526/ 2023-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k232526-xidf-aws801-angio-workstation-alphenix-fda-510k.jpg K232526 - XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.5 K232526 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Sep 2023. https://www.510kdatabase.net/k223755/ 2023-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k223755-i-stat-g-cartridge-with-the-i-stat-1-fda-510k.jpg K223755 - i-STAT G cartridge with the i-STAT 1 System K223755 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Point of Care, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k230362/ 2023-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k230362-planar-led-mate-fda-510k.jpg K230362 - Planar LED mate K230362 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Leaflife Technology Co., Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k230517/ 2023-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k230517-legends-orthopedics-suture-anchors-fda-510k.jpg K230517 - Legends Orthopedics Suture Anchors (Legends Orthopedics 5.5 mm Suture Anchors, Legends Orthopedics 2.9 mm Suture Anchor, and Legends Orthopedics 5.5 mm Knotless Suture Anchor) K230517 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Jarmon Medical, LLC (Dba Legends Orthopedics). Cleared Sep 2023. https://www.510kdatabase.net/k230881/ 2023-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k230881-change-healthcare-cardiology-fda-510k.jpg K230881 - Change Healthcare Cardiology Hemodynamics™ K230881 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Change Healthcare Israel , Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k231283/ 2023-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k231283-siterite-9-ultrasound-system-fda-510k.jpg K231283 - SiteRite™ 9 Ultrasound System K231283 is a FDA 510(k) cleared radiology medical device. Manufacturer: Bard Access Systems, Inc. (C.R. Bard, Inc.). Cleared Sep 2023. https://www.510kdatabase.net/k231504/ 2023-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k231504-titanex-microbeam-screw-system-titanex-fda-510k.jpg K231504 - TITANEX™ MICROBEAM Screw System, TITANEX™ ARTEMIS Screw System K231504 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Vilex, LLC. Cleared Sep 2023. https://www.510kdatabase.net/k231746/ 2023-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k231746-verify-spore-test-strip-for-s40-fda-510k.jpg K231746 - VERIFY Spore Test Strip for S40 Sterilant Concentrate K231746 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Sep 2023. https://www.510kdatabase.net/k232002/ 2023-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k232002-vantage-total-ankle-system-fda-510k.jpg K232002 - Vantage® Total Ankle System K232002 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k232154/ 2023-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k232154-mirus-3dr-lateral-lumbar-interbody-fda-510k.jpg K232154 - MiRus 3DR Lateral Lumbar Interbody Fusion System with Integrated Plate Fixation K232154 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: MiRus, LLC. Cleared Sep 2023. https://www.510kdatabase.net/k232192/ 2023-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k232192-venus-versa-pro-system-fda-510k.jpg K232192 - Venus Versa PRO System K232192 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Venus Concept, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k223864/ 2023-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k223864-alignment-system-cranial-alignment-fda-510k.jpg K223864 - Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial K223864 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Sep 2023. https://www.510kdatabase.net/k213510/ 2023-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k213510-immuliteimmulite-1000-om-ma-immulite-fda-510k.jpg K213510 - IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA K213510 is a FDA 510(k) cleared immunology medical device. Manufacturer: Siemens Healthcare Diagnostics Products, Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k222921/ 2023-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k222921-minuteful-kidney-test-fda-510k.jpg K222921 - Minuteful-kidney test K222921 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Healthy.Io, Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k223621/ 2023-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k223621-deepxray-fda-510k.jpg K223621 - DeepXray K223621 is a FDA 510(k) cleared radiology medical device. Manufacturer: Alpha Intelligence Manifolds, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k223827/ 2023-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k223827-fujifilm-endoscope-model-ec-760s-al-fda-510k.jpg K223827 - FUJIFILM Endoscope Model EC-760S-A/L, Endoscopy Support Program EW10-VM01 K223827 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fujifilm Corporation. Cleared Sep 2023. https://www.510kdatabase.net/k223848/ 2023-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k223848-intrisound-tuned-lumen-155-hearing-aids-fda-510k.jpg K223848 - Intrisound™ Tuned Lumen® 155 Hearing Aids K223848 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Tuned , Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k230310/ 2023-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k230310-stat-medical-device-lancing-system-fda-510k.jpg K230310 - STAT Medical Device Lancing System K230310 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stat Medical Devices. Cleared Sep 2023. https://www.510kdatabase.net/k230372/ 2023-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k230372-vitreject-syringe-fda-510k.jpg K230372 - VitreJect Syringe K230372 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ocuject, LLC. Cleared Sep 2023. https://www.510kdatabase.net/k230535/ 2023-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k230535-karl-storz-urological-laser-accessories-fda-510k.jpg K230535 - KARL STORZ Urological Laser Accessories K230535 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Karl Storz SE & CO. KG. Cleared Sep 2023. https://www.510kdatabase.net/k230661/ 2023-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k230661-zeta-cranial-navigation-system-fda-510k.jpg K230661 - Zeta Cranial Navigation System K230661 is a FDA 510(k) cleared neurology medical device. Manufacturer: Zeta Surgical. Cleared Sep 2023. https://www.510kdatabase.net/k230890/ 2023-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k230890-ise-electrodes-fda-510k.jpg K230890 - ISE Electrodes K230890 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Randox Laboratories, Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k231141/ 2023-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k231141-starfix-designer-software-c0265-fda-510k.jpg K231141 - STarFix Designer Software C0265 K231141 is a FDA 510(k) cleared neurology medical device. Manufacturer: FHC, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k231146/ 2023-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k231146-alitight-fda-510k.jpg K231146 - AliTight K231146 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Alic Iotech, LLC. Cleared Sep 2023. https://www.510kdatabase.net/k231240/ 2023-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k231240-maxtack-motorized-fixation-device-fda-510k.jpg K231240 - MaxTack™ Motorized Fixation Device K231240 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien. Cleared Sep 2023. https://www.510kdatabase.net/k231284/ 2023-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k231284-onpoint-augmented-reality-spine-system-fda-510k.jpg K231284 - OnPoint Augmented Reality Spine System K231284 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Onpoint Surgical, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k231335/ 2023-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k231335-cleerly-ischemia-fda-510k.jpg K231335 - Cleerly ISCHEMIA K231335 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cleerly, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k231471/ 2023-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k231471-airwater-bottle-tubing-co2-source-tubing-fda-510k.jpg K231471 - Air/Water Bottle Tubing, CO2 Source Tubing K231471 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Zhejiang Chuangxiang Medical Technology Co., Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k231643/ 2023-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k231643-biodegradable-nitrile-powder-free-fda-510k.jpg K231643 - Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) K231643 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Syntex Healthcare Products Co., Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k231720/ 2023-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k231720-sterile-hypodermic-needles-for-single-fda-510k.jpg K231720 - Sterile Hypodermic Needles for Single Use K231720 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wepon Medical Technology Co., Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k231723/ 2023-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k231723-sterile-safety-hypodermic-needles-for-fda-510k.jpg K231723 - Sterile Safety Hypodermic Needles for Single Use K231723 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wepon Medical Technology Co., Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k231727/ 2023-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k231727-sterile-auto-disable-syringes-fda-510k.jpg K231727 - Sterile Auto-Disable Syringes with/without Needle for Single Use K231727 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wepon Medical Technology Co., Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k231729/ 2023-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k231729-sterile-syringes-for-single-use-fda-510k.jpg K231729 - Sterile syringes for single use with/without needle K231729 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wepon Medical Technology Co., Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k232166/ 2023-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k232166-prexion3d-expedition-fda-510k.jpg K232166 - PreXion3D Expedition K232166 is a FDA 510(k) cleared radiology medical device. Manufacturer: Prexion Corporation. Cleared Sep 2023. https://www.510kdatabase.net/k232386/ 2023-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k232386-ilumien-optis-system-optis-integrated-fda-510k.jpg K232386 - ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with AptiVue™ Imaging Software version E.6 K232386 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared Sep 2023. https://www.510kdatabase.net/k232400/ 2023-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k232400-variseed-v10-fda-510k.jpg K232400 - VariSeed (v10) K232400 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems. Cleared Sep 2023. https://www.510kdatabase.net/k232413/ 2023-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k232413-fusion-robotic-navigation-system-fda-510k.jpg K232413 - Fusion Robotic Navigation System K232413 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k232414/ 2023-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k232414-klassic-tibial-insert-ps-post-klassic-fda-510k.jpg K232414 - Klassic® Tibial Insert, PS-Post, Klassic All Poly Tibia, PS-Post K232414 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Total Joint Othopedics, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k232426/ 2023-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k232426-identity-imprint-porous-cruciate-fda-510k.jpg K232426 - Identity Imprint Porous Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Inserts K232426 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Conformis, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k232457/ 2023-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k232457-q-fix-ultra-all-suture-anchor-fda-510k.jpg K232457 - Q-FIX ULTRA All-Suture Anchor K232457 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew. Cleared Sep 2023. https://www.510kdatabase.net/k232686/ 2023-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k232686-corvista-system-fda-510k.jpg K232686 - CorVista® System K232686 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Corvista Health, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k221743/ 2023-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k221743-radio-frequency-plasma-surgical-systems-fda-510k.jpg K221743 - Radio Frequency Plasma Surgical Systems K221743 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Jiangsu Bonss Medical Technology Co., Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k222823/ 2023-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k222823-aerodvx-arm-system-fda-510k.jpg K222823 - AeroDVx Arm System K222823 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sun Scientific, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k230049/ 2023-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k230049-skore-smooth-dotted-thin-condoms-skore-fda-510k.jpg K230049 - SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine K230049 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ttk Healthcare Limited. Cleared Sep 2023. https://www.510kdatabase.net/k230644/ 2023-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k230644-signum-opaque-f-fda-510k.jpg K230644 - Signum opaque F K230644 is a FDA 510(k) cleared dental medical device. Manufacturer: Kulzer, LLC. Cleared Sep 2023. https://www.510kdatabase.net/k230649/ 2023-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k230649-arm-blood-pressure-monitor-fda-510k.jpg K230649 - Arm Blood Pressure Monitor K230649 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Alicn Medical (Shenzhen), Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k231207/ 2023-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k231207-carto-3-ep-navigation-system-software-fda-510k.jpg K231207 - CARTO™ 3 EP Navigation System Software V8.0 (FG-5400-00, FG-5400-00U) K231207 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biosense Webster, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k231542/ 2023-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k231542-digital-blood-pressure-monitor-wbp-fda-510k.jpg K231542 - Digital Blood Pressure Monitor WBP Series K231542 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Weony (Shenzhen) Technology Co., Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k231687/ 2023-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k231687-gradual-dental-zirconia-blank-fda-510k.jpg K231687 - Gradual Dental Zirconia Blank K231687 is a FDA 510(k) cleared dental medical device. Manufacturer: Liaoning Upcera Co., Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k231800/ 2023-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k231800-ipl-hair-removal-device-models-jp1-jr3-fda-510k.jpg K231800 - IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9 K231800 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Qianyu Technology Co., Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k231828/ 2023-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k231828-pounce-sheath-fda-510k.jpg K231828 - Pounce™ Sheath K231828 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Surmodics,Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k231996/ 2023-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k231996-steriking-lt-blueline-pouches-with-tyvek-fda-510k.jpg K231996 - Steriking® LT-Blueline Pouches with Tyvek® K231996 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wipak OY. Cleared Sep 2023. https://www.510kdatabase.net/k231999/ 2023-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k231999-steriking-lt-blueline-pouches-with-tyvek-fda-510k.jpg K231999 - Steriking® LT-Blueline Pouches with Tyvek® K231999 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wipak OY. Cleared Sep 2023. https://www.510kdatabase.net/k232389/ 2023-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k232389-carescape-spo2-masimo-fda-510k.jpg K232389 - Carescape SpO2 - Masimo K232389 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Masimo Corporation. Cleared Sep 2023. https://www.510kdatabase.net/k232443/ 2023-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k232443-single-loop-snare-retrieval-kit-triple-fda-510k.jpg K232443 - Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit K232443 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Argon Medical Devices, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k223575/ 2023-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k223575-phoenix-icon-phoenix-icon-go-fda-510k.jpg K223575 - Phoenix ICON, Phoenix ICON GO K223575 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Neolight, LLC. Cleared Sep 2023. https://www.510kdatabase.net/k230024/ 2023-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k230024-hi-emt-magshape-fda-510k.jpg K230024 - HI-EMT MAGSHAPE K230024 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Beijing Sano Laser S&T Development Co.,Ltd. Cleared Sep 2023. https://www.510kdatabase.net/k230127/ 2023-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k230127-biliary-plastic-stent-biliary-plastic-fda-510k.jpg K230127 - Biliary Plastic Stent, Biliary Plastic Stent Introducer, Biliary Plastic Stent Set, Biliary Plastic Stent Introducer/ short-wire compatible, Biliary Plastic Stent Set/ short-wire compatible K230127 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Micro-Tech (Nanjing) Co., Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k230824/ 2023-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k230824-intelliwave3-silicone-hydrogel-daily-fda-510k.jpg K230824 - IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) K230824 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Art Optical Contact Lens, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k231717/ 2023-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k231717-ipl-home-use-hair-removal-device-fda-510k.jpg K231717 - IPL Home Use Hair Removal Device, Model(s): JD-TM002, JD-TM003, JD-TM012, JD-TM016, JD-TM022 K231717 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Foshan Jindi Electric Appliance Co., Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k232482/ 2023-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k232482-magnetom-viatomobile-fda-510k.jpg K232482 - MAGNETOM Viato.Mobile K232482 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/den230006/ 2023-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/den230006-esolution-fda-510k.jpg DEN230006 - esolution DEN230006 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: S4 Medical Corp.. Cleared Sep 2023. https://www.510kdatabase.net/k200583/ 2023-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k200583-ki-mobility-focus-cr-ki-mobility-focus-fda-510k.jpg K200583 - Ki Mobility Focus CR, Ki Mobility Focus CRe, Ki Mobility Focus CR TTL K200583 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Ki Mobility, LLC. Cleared Sep 2023. https://www.510kdatabase.net/k201869/ 2023-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k201869-ki-power-tilt-system-fda-510k.jpg K201869 - Ki Power Tilt System K201869 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Ki Mobility, LLC. Cleared Sep 2023. https://www.510kdatabase.net/k221197/ 2023-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k221197-vitros-immunodiagnostic-products-fda-510k.jpg K221197 - VITROS Immunodiagnostic Products Intact PTH II Reagent Pack K221197 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Ortho-Clinical Diagnostics. Cleared Sep 2023. https://www.510kdatabase.net/k221869/ 2023-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k221869-bcr-abl1-p210-is-kit-digital-pcr-method-fda-510k.jpg K221869 - BCR-ABL1 (p210) % IS Kit (Digital PCR Method) K221869 is a FDA 510(k) cleared medical genetics medical device. Manufacturer: Suzhou Sniper Medical Technologies Co., Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k223684/ 2023-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k223684-fp-820-humidification-system-fda-510k.jpg K223684 - F&P 820 Humidification System K223684 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Fisher &Paykel Healthcare , Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k230743/ 2023-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k230743-ichor-14f-embolectomy-system-fda-510k.jpg K230743 - ICHOR 14F Embolectomy System K230743 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ichor. Cleared Sep 2023. https://www.510kdatabase.net/k231819/ 2023-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k231819-quick-start-orthopaedic-fixation-screw-fda-510k.jpg K231819 - Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw K231819 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Innovate Orthopaedics Limited. Cleared Sep 2023. https://www.510kdatabase.net/k232361/ 2023-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k232361-promaxo-mri-system-ii-fda-510k.jpg K232361 - Promaxo MRI System II K232361 is a FDA 510(k) cleared radiology medical device. Manufacturer: Promaxo, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k232691/ 2023-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k232691-polibond-fda-510k.jpg K232691 - Polibond K232691 is a FDA 510(k) cleared dental medical device. Manufacturer: Zirkonzahn Srl. Cleared Sep 2023. https://www.510kdatabase.net/k213273/ 2023-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k213273-brain-anesthesia-response-monitor-bar-fda-510k.jpg K213273 - Brain Anesthesia Response Monitor (Bar Monitor) K213273 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Cortical Dynamics , Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k213413/ 2023-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k213413-hemostatic-dressing-fda-510k.jpg K213413 - Hemostatic Dressing K213413 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Jiangsu Newvalue Medical Products Co., Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k221601/ 2023-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k221601-ms-39-fda-510k.jpg K221601 - MS-39 K221601 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: C.S.O. S.R.L.. Cleared Sep 2023. https://www.510kdatabase.net/k222988/ 2023-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k222988-neowave-ls-lumbar-straight-neowave-c-fda-510k.jpg K222988 - neoWave LS Lumbar Straight, neoWave C Cervical, and Ti3D Cervical K222988 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ht Medical D.B.A. Xenix Medical. Cleared Sep 2023. https://www.510kdatabase.net/k223622/ 2023-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k223622-faceheart-vitals-software-development-fda-510k.jpg K223622 - FaceHeart Vitals Software Development Kit (FH vitals SDK) K223622 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Faceheart Corp.. Cleared Sep 2023. https://www.510kdatabase.net/k223674/ 2023-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k223674-ezsure-empty-fluid-container-models-fda-510k.jpg K223674 - eZSURE™ Empty Fluid Container (models 426030, 426040, 426110) K223674 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Epic Medical Pte. , Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k223901/ 2023-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k223901-apnearx-pro-fda-510k.jpg K223901 - ApneaRX Pro K223901 is a FDA 510(k) cleared dental medical device. Manufacturer: Apnea Sciences Coporation. Cleared Sep 2023. https://www.510kdatabase.net/k230317/ 2023-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k230317-elos-accurate-hybrid-base-fda-510k.jpg K230317 - Elos Accurate Hybrid Base K230317 is a FDA 510(k) cleared dental medical device. Manufacturer: Elos Medtech Pinol A/S. Cleared Sep 2023. https://www.510kdatabase.net/k230623/ 2023-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k230623-kite-distal-fibula-kit-fda-510k.jpg K230623 - KITE Distal Fibula Kit K230623 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Intrauma S.P.A. Cleared Sep 2023. https://www.510kdatabase.net/k230805/ 2023-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k230805-trimed-clavicle-fixation-system-fda-510k.jpg K230805 - TriMed Clavicle Fixation System K230805 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: TriMed, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k230918/ 2023-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k230918-masterx-800-series-fda-510k.jpg K230918 - MasterX 800 Series K230918 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medicatech USA. Cleared Sep 2023. https://www.510kdatabase.net/k231047/ 2023-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k231047-unisyn-molecular-imaging-6-3-1-fda-510k.jpg K231047 - UniSyn Molecular Imaging (6-3-1) K231047 is a FDA 510(k) cleared radiology medical device. Manufacturer: Convergent Imaging Solutions. Cleared Sep 2023. https://www.510kdatabase.net/k231270/ 2023-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k231270-montage-flowable-settable-resorbable-fda-510k.jpg K231270 - Montage Flowable Settable, Resorbable Bone Paste K231270 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthocon, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k231710/ 2023-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k231710-ow100s-fda-510k.jpg K231710 - OW100S K231710 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Softwave/Trt, LLC. Cleared Sep 2023. https://www.510kdatabase.net/k231884/ 2023-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k231884-trioclear-system-fda-510k.jpg K231884 - TRIOCLEAR System K231884 is a FDA 510(k) cleared dental medical device. Manufacturer: Modern Dental Laboratory (Dg) Co., Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k232014/ 2023-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k232014-conduit-atp-inserters-fda-510k.jpg K232014 - CONDUIT™ ATP Inserters K232014 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Enztec Limited. Cleared Sep 2023. https://www.510kdatabase.net/k232021/ 2023-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k232021-smart-fit-torsocardiac-15t-and-smart-fda-510k.jpg K232021 - Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T K232021 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Healthcare (Suzhou) Co., Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k232068/ 2023-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k232068-hyperlight-portable-x-ray-unit-fda-510k.jpg K232068 - HyperLight Portable X-ray Unit K232068 is a FDA 510(k) cleared radiology medical device. Manufacturer: Changzhou Sifary Medical Technology Co., Ltd.. Cleared Sep 2023. https://www.510kdatabase.net/k232314/ 2023-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k232314-hood-dh-106stl-dh-116stl-dh-126stl-dh-fda-510k.jpg K232314 - Hood (DH-106STL, DH-116STL, DH-126STL, DH-096ST) K232314 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fujifilm Healthcare Americas Corporation. Cleared Sep 2023. https://www.510kdatabase.net/k232334/ 2023-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k232334-deka-simon-fda-510k.jpg K232334 - DEKA SIMON K232334 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: El.En S.P.A.. Cleared Sep 2023. https://www.510kdatabase.net/k232340/ 2023-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k232340-arthrex-24mm-knotless-hip-suturetak-fda-510k.jpg K232340 - Arthrex 2.4mm Knotless Hip SutureTak® Suture Anchor K232340 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k232657/ 2023-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k232657-innerview-lc-fda-510k.jpg K232657 - InnerView LC K232657 is a FDA 510(k) cleared dental medical device. Manufacturer: Perimetrics, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/den230007/ 2023-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/den230007-lightstrike-mxsuv1-sl-and-mxsuv1-ft-fda-510k.jpg DEN230007 - LightStrike+ (MXSUV1-SL and MXSUV1-FT) DEN230007 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Xenex Disinfection Services, Inc.. Cleared Sep 2023. https://www.510kdatabase.net/k213271/ 2023-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k213271-mediclosetm-system-fda-510k.jpg K213271 - MedicloseTM System K213271 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Health Value Creation B.V., Trading AS Corporis Medical. Cleared Aug 2023. https://www.510kdatabase.net/k221959/ 2023-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k221959-q21-fda-510k.jpg K221959 - Q21 K221959 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neurofield, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k222563/ 2023-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k222563-bd-kiestra-identifa-fda-510k.jpg K222563 - BD Kiestra IdentifA K222563 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson and Company. Cleared Aug 2023. https://www.510kdatabase.net/k223527/ 2023-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k223527-little-wave-clik-rogue-xp-little-wave-fda-510k.jpg K223527 - Little Wave Clik, Rogue XP, Little Wave XP, Spark K223527 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Ki Mobility, LLC. Cleared Aug 2023. https://www.510kdatabase.net/k223533/ 2023-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k223533-little-wave-arc-fda-510k.jpg K223533 - Little Wave Arc K223533 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Ki Mobility, LLC. Cleared Aug 2023. https://www.510kdatabase.net/k223597/ 2023-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k223597-23andme-personal-genome-service-pgs-fda-510k.jpg K223597 - 23andMe® Personal Genome Service® (PGS®) Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) K223597 is a FDA 510(k) cleared pathology medical device. Manufacturer: 23AndMe, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k230488/ 2023-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k230488-el27-compact-fda-510k.jpg K230488 - EL27-Compact K230488 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Walz Elektronik GmbH. Cleared Aug 2023. https://www.510kdatabase.net/k230578/ 2023-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k230578-polyisoprene-surgical-glove-unified-fda-510k.jpg K230578 - Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl K230578 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wrp Asia Pacific Sdn. Bhd.. Cleared Aug 2023. https://www.510kdatabase.net/k231323/ 2023-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k231323-ancora-sb-fda-510k.jpg K231323 - Ancora-SB K231323 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Aspero Medical, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k231433/ 2023-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k231433-the-sensititre-yeastone-susceptibility-fda-510k.jpg K231433 - The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL K231433 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Thermo Fisher Scientific. Cleared Aug 2023. https://www.510kdatabase.net/k231611/ 2023-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k231611-holo-portal-surgical-guidance-system-fda-510k.jpg K231611 - HOLO Portal™ Surgical Guidance System K231611 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Surgalign Spine Technologies. Cleared Aug 2023. https://www.510kdatabase.net/k231616/ 2023-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k231616-zeus-ifatm-ndna-test-system-zeus-difine-fda-510k.jpg K231616 - ZEUS IFA(TM) nDNA Test System, ZEUS dIFine K231616 is a FDA 510(k) cleared immunology medical device. Manufacturer: Zeus Scientific. Cleared Aug 2023. https://www.510kdatabase.net/k231626/ 2023-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k231626-osprey-closed-iv-catheter-system-fda-510k.jpg K231626 - OSPREY Closed IV Catheter System (OspreyV2) K231626 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Skydance Vascular, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k231978/ 2023-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k231978-biosieve-marijuana-test-panel-50-fda-510k.jpg K231978 - BioSieve™ Marijuana Test Panel 50 K231978 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Vivachek Biotech (Hangzhou) Co., Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k232287/ 2023-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k232287-rayscan-a-expert3d-fda-510k.jpg K232287 - RAYSCAN a-Expert3D K232287 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ray Co., Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k232353/ 2023-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k232353-powder-free-nitrile-examination-gloves-fda-510k.jpg K232353 - Powder Free Nitrile Examination Gloves (Black) K232353 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shanxi Hongjin Plastic Technology Co., Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k213418/ 2023-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k213418-montage-settable-resorbable-hemostatic-fda-510k.jpg K213418 - MONTAGE Settable, Resorbable Hemostatic Bone Putty K213418 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Orthocon, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k223130/ 2023-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k223130-shiley-pediatric-oralnasal-fda-510k.jpg K223130 - Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160) K223130 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Covidien. Cleared Aug 2023. https://www.510kdatabase.net/k223303/ 2023-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k223303-spinery-rf-ablation-system-fda-510k.jpg K223303 - Spinery™ RF Ablation System K223303 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Axon Spine Medical System. Cleared Aug 2023. https://www.510kdatabase.net/k223367/ 2023-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k223367-ochsner-connected-inhaler-sensor-fda-510k.jpg K223367 - Ochsner Connected Inhaler Sensor K223367 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Ochsner Clinic Foundation. Cleared Aug 2023. https://www.510kdatabase.net/k223468/ 2023-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k223468-nexis-compressive-screws-fda-510k.jpg K223468 - Nexis® compressive screws K223468 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Novastep. Cleared Aug 2023. https://www.510kdatabase.net/k230013/ 2023-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k230013-silkn-titan-allways-fda-510k.jpg K230013 - Silk'n Titan Allways K230013 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Silk'N Beauty , Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k230155/ 2023-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k230155-mick-valencia-applicator-set-fda-510k.jpg K230155 - Mick Valencia Applicator Set K230155 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mick Radio-Nuclear Instruments, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k230355/ 2023-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k230355-vantage-galan-3t-mrt-3020-v90-with-fda-510k.jpg K230355 - Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR K230355 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Aug 2023. https://www.510kdatabase.net/k230603/ 2023-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k230603-arrow-non-stimulating-snaplock-adapter-fda-510k.jpg K230603 - Arrow Non-Stimulating SnapLock Adapter (K-05520-005C) K230603 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Teleflex Medical. Cleared Aug 2023. https://www.510kdatabase.net/k231024/ 2023-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k231024-aquabeam-robotic-system-fda-510k.jpg K231024 - AquaBeam Robotic System K231024 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Procept Biorobotics, Corporation. Cleared Aug 2023. https://www.510kdatabase.net/k231093/ 2023-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k231093-alphavent-suture-anchors-fda-510k.jpg K231093 - AlphaVent Suture Anchors K231093 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Endoscopy. Cleared Aug 2023. https://www.510kdatabase.net/k231123/ 2023-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k231123-phoenix-contact-lens-case-dome-top-fda-510k.jpg K231123 - Phoenix Contact Lens Case - dome top flat pack (CL-01) K231123 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k231156/ 2023-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k231156-enzyme-packed-cartridge-relizorb-fda-510k.jpg K231156 - Enzyme Packed Cartridge - RELiZORB K231156 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Alcresta Therapeutics, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k231246/ 2023-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k231246-ventrax-delivery-system-vtr851-fda-510k.jpg K231246 - Ventrax™ Delivery System (VTR851) K231246 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k231276/ 2023-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k231276-smartcardia-7l-platform-fda-510k.jpg K231276 - SmartCardia 7L Platform K231276 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Smartcardia SA. Cleared Aug 2023. https://www.510kdatabase.net/k231289/ 2023-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k231289-s-patch-ex-wearable-ecg-patch-fda-510k.jpg K231289 - S-Patch Ex Wearable ECG Patch K231289 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Wellysis Corp.. Cleared Aug 2023. https://www.510kdatabase.net/k231580/ 2023-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k231580-nim-35cm-long-surgeon-control-probe-fda-510k.jpg K231580 - NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) K231580 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Medtronic Xomed, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k231656/ 2023-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k231656-brainomix-360-e-mri-fda-510k.jpg K231656 - Brainomix 360 e-MRI K231656 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainomix Limited. Cleared Aug 2023. https://www.510kdatabase.net/k231961/ 2023-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k231961-nibpcuff-fda-510k.jpg K231961 - NIBPCuff K231961 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Sino-K Medical Technology Co.,Ltd. Cleared Aug 2023. https://www.510kdatabase.net/k231988/ 2023-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k231988-sensititre-20-24-hour-haemophilus-fda-510k.jpg K231988 - Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dalbavancin in the dilution range of 0.0005-2µg/ml K231988 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Thermo Fisher Scientific. Cleared Aug 2023. https://www.510kdatabase.net/k232295/ 2023-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k232295-laa-exclusion-system-fda-510k.jpg K232295 - LAA Exclusion System K232295 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Syntheon, LLC. Cleared Aug 2023. https://www.510kdatabase.net/k232324/ 2023-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k232324-stealthfix-intraosseous-fixation-system-fda-510k.jpg K232324 - StealthFix Intraosseous Fixation System K232324 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medartis, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k232343/ 2023-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k232343-ac3-series-iabp-fda-510k.jpg K232343 - AC3™ Series IABP K232343 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Arrow International, LLC. Cleared Aug 2023. https://www.510kdatabase.net/k221361/ 2023-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k221361-circul-pro-ring-fda-510k.jpg K221361 - circul™ pro Ring K221361 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Bodimetrics, LLC. Cleared Aug 2023. https://www.510kdatabase.net/k230765/ 2023-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k230765-precice-ankle-salvage-system-fda-510k.jpg K230765 - Precice Ankle Salvage System K230765 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nuvasive Specialized Orthopedics, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k231407/ 2023-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k231407-starfin-fda-510k.jpg K231407 - StarFin K231407 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Premium Medical Technology, LLC. Cleared Aug 2023. https://www.510kdatabase.net/k232226/ 2023-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k232226-arrow-off-centred-humeral-insert-fda-510k.jpg K232226 - ARROW Off-Centred Humeral Insert K232226 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: FH Industrie. Cleared Aug 2023. https://www.510kdatabase.net/k232313/ 2023-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k232313-ligaclip-endoscopic-rotating-multiple-fda-510k.jpg K232313 - LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420) K232313 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon Endo-Surgery, LLC. Cleared Aug 2023. https://www.510kdatabase.net/k222525/ 2023-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k222525-alveoair-digital-spirometer-fda-510k.jpg K222525 - Alveoair Digital Spirometer K222525 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Roundworks Technologies Private Limited. Cleared Aug 2023. https://www.510kdatabase.net/k223639/ 2023-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k223639-visableio-fda-510k.jpg K223639 - VisAble.IO K223639 is a FDA 510(k) cleared radiology medical device. Manufacturer: Techsomed. Cleared Aug 2023. https://www.510kdatabase.net/k230159/ 2023-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k230159-soundbite-crossing-system-xs-peripheral-fda-510k.jpg K230159 - SoundBite® Crossing System XS Peripheral K230159 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Soundbite Medical Solutions, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k230221/ 2023-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k230221-qdose-multi-purpose-voxel-dosimetry-fda-510k.jpg K230221 - QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy) K230221 is a FDA 510(k) cleared radiology medical device. Manufacturer: Versant Medical Physics and Radiation Safety. Cleared Aug 2023. https://www.510kdatabase.net/k231422/ 2023-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k231422-precision-gi-fda-510k.jpg K231422 - Precision GI K231422 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Limaca Medical, Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k231435/ 2023-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k231435-kimtech-polaris-xtra-nitrile-powder-fda-510k.jpg K231435 - KIMTECH™ Polaris™ Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid K231435 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Kimberly Clark Corporation. Cleared Aug 2023. https://www.510kdatabase.net/k231537/ 2023-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k231537-sofwave-system-fda-510k.jpg K231537 - SofWave System K231537 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sofwave Medical, Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k231623/ 2023-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k231623-distal-elbow-plating-system-fda-510k.jpg K231623 - Distal Elbow Plating System K231623 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Skeletal Dynamics, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k231676/ 2023-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k231676-callisto-eye-fda-510k.jpg K231676 - CALLISTO eye K231676 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Carl Zeiss Meditec, AG. Cleared Aug 2023. https://www.510kdatabase.net/k232387/ 2023-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k232387-treace-medical-concepts-tmc-fda-510k.jpg K232387 - Treace Medical Concepts (TMC) Compression Implant System K232387 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Treace Medical Concepts. Cleared Aug 2023. https://www.510kdatabase.net/k213670/ 2023-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k213670-bd-vacutainer-k2edta-blood-collection-fda-510k.jpg K213670 - BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes K213670 is a FDA 510(k) cleared hematology medical device. Manufacturer: Becton, Dickinson and Company. Cleared Aug 2023. https://www.510kdatabase.net/k222786/ 2023-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k222786-072-aspiration-system-fda-510k.jpg K222786 - 072 Aspiration System K222786 is a FDA 510(k) cleared neurology medical device. Manufacturer: Q'Apel Medical, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k222972/ 2023-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k222972-bioprotect-balloon-implant-system-fda-510k.jpg K222972 - BioProtect Balloon Implant™ System K222972 is a FDA 510(k) cleared radiology medical device. Manufacturer: Bioprotect, Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k223180/ 2023-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k223180-airascore-fda-510k.jpg K223180 - AIRAscore K223180 is a FDA 510(k) cleared radiology medical device. Manufacturer: Airamed GmbH. Cleared Aug 2023. https://www.510kdatabase.net/k223600/ 2023-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k223600-sterilization-wrap-fda-510k.jpg K223600 - Sterilization Wrap K223600 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wuhan Zonsen Medical Products Co., Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k223727/ 2023-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k223727-lavieen-fda-510k.jpg K223727 - Lavieen K223727 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wontech Co., Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k223807/ 2023-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k223807-reusable-temperature-probe-disposable-fda-510k.jpg K223807 - Reusable Temperature Probe, Disposable Temperature Probe K223807 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen Sino-K Medical Technology Co.,Ltd. Cleared Aug 2023. https://www.510kdatabase.net/k223898/ 2023-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k223898-vitalflowtm-centrifugal-pump-fda-510k.jpg K223898 - VitalFlowTM Centrifugal Pump K223898 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.). Cleared Aug 2023. https://www.510kdatabase.net/k230014/ 2023-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k230014-magventure-pain-therapy-magpro-r30-fda-510k.jpg K230014 - MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption K230014 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Tonica Elektronik A/S. Cleared Aug 2023. https://www.510kdatabase.net/k230094/ 2023-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k230094-responsive-arthroscopy-stealth-and-fda-510k.jpg K230094 - Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors K230094 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Responsive Arthroscopy, LLC. Cleared Aug 2023. https://www.510kdatabase.net/k230165/ 2023-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k230165-luja-coud-20118-male-ch8-small-fda-510k.jpg K230165 - Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small packaging (Pocket size)), Luja Coudé (20112 Male CH12 - small packaging (Pocket size)), Luja Coudé (20114 Male CH14 - small packaging (Pocket size)), Luja Coudé (20101 Male CH10 - large packaging), Luja Coudé (20102 Male CH12 - large packaging), Luja Coudé (20104 Male CH14 - large packaging), Luja Coudé (20106 Male CH16 - large packaging) K230165 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Coloplast. Cleared Aug 2023. https://www.510kdatabase.net/k230364/ 2023-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k230364-vitalflow-console-fda-510k.jpg K230364 - VitalFlow™ Console K230364 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Michigan Critical Care Consultants, Inc. (D.B.A Mc3 Inc.). Cleared Aug 2023. https://www.510kdatabase.net/k230409/ 2023-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k230409-wrist-type-blood-pressure-monitor-fda-510k.jpg K230409 - Wrist Type Blood Pressure Monitor (W05,W1101L) K230409 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Jamr Technology Co., Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k230566/ 2023-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k230566-arm-type-fully-automatic-digital-blood-fda-510k.jpg K230566 - Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor K230566 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Joytech Healthcare Co. , Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k230928/ 2023-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k230928-vein360-reprocessed-visions-pv018-fda-510k.jpg K230928 - Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter K230928 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vein 360, LLC. Cleared Aug 2023. https://www.510kdatabase.net/k231183/ 2023-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k231183-non-absorbable-surgical-polyester-suture-fda-510k.jpg K231183 - Non absorbable Surgical Polyester Suture K231183 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shandong Haidike Medical Products Co., Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k231255/ 2023-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k231255-novofine-plus-fda-510k.jpg K231255 - NovoFine® Plus K231255 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Novo Nordisk, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k231872/ 2023-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k231872-polaris-bipolar-electrosurgical-fda-510k.jpg K231872 - Polaris Bipolar Electrosurgical Generator (29-1000) K231872 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Kirwan Surgical Products, LLC. Cleared Aug 2023. https://www.510kdatabase.net/k231903/ 2023-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k231903-montage-qs-settable-resorbable-bone-fda-510k.jpg K231903 - Montage-QS Settable, Resorbable Bone Putty K231903 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthocon, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k231994/ 2023-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k231994-sensititre-18-24-hour-mic-or-fda-510k.jpg K231994 - Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/4-32/4 ug/mL K231994 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Thermo Fisher Scientific. Cleared Aug 2023. https://www.510kdatabase.net/k232214/ 2023-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k232214-omni-surgical-system-fda-510k.jpg K232214 - OMNI Surgical System K232214 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Sight Sciences, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k212766/ 2023-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k212766-maxiocel-chitosan-wound-dressing-fda-510k.jpg K212766 - Maxiocel Chitosan Wound Dressing K212766 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Advamedica, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k220085/ 2023-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k220085-kronus-ia-2-autoantibody-ia-2ab-elisa-fda-510k.jpg K220085 - KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit K220085 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Kronus, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k220145/ 2023-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k220145-monaghan-medical-filtered-mouthpiece-kit-fda-510k.jpg K220145 - Monaghan medical filtered mouthpiece kit K220145 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Monaghan Medical Corporation. Cleared Aug 2023. https://www.510kdatabase.net/k222103/ 2023-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k222103-nitrile-patient-examination-gloves-fda-510k.jpg K222103 - Nitrile Patient Examination Gloves, Powder Free, Pink Color K222103 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shandong Yinghng Medical Products Co., Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k223150/ 2023-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k223150-aps-metal-plate-screw-system-fda-510k.jpg K223150 - APS Metal Plate & Screw System K223150 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: A Plus Biotechnology Co., Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k223606/ 2023-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k223606-lifeshield-infusion-safety-software-fda-510k.jpg K223606 - LifeShield™ Infusion Safety Software Suite K223606 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Icu Medical, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k223607/ 2023-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k223607-plum-duo-infusion-system-fda-510k.jpg K223607 - Plum Duo™ Infusion System K223607 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Icu Medical, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k230976/ 2023-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k230976-arthrex-radiopaque-fibertape-cerclage-fda-510k.jpg K230976 - Arthrex Radiopaque FiberTape Cerclage sutures K230976 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k231274/ 2023-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k231274-natural-cycles-fda-510k.jpg K231274 - Natural Cycles K231274 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Natural Cycles Nordic AB. Cleared Aug 2023. https://www.510kdatabase.net/k231506/ 2023-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k231506-current-health-system-fda-510k.jpg K231506 - Current Health System K231506 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Current Health , Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k231557/ 2023-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k231557-zenex-freemilling-ccm-cast-abutment-fda-510k.jpg K231557 - ZENEX FreeMilling & CCM Cast Abutment K231557 is a FDA 510(k) cleared dental medical device. Manufacturer: Izenimplant Co., Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k231599/ 2023-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k231599-stryker-mp-mandible-hmmf-and-mmf-axs-fda-510k.jpg K231599 - Stryker MP, Mandible, HMMF and MMF AXS Screws K231599 is a FDA 510(k) cleared dental medical device. Manufacturer: Stryker Leibinger GmbH & Co KG. Cleared Aug 2023. https://www.510kdatabase.net/k231604/ 2023-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k231604-instrument-case-fda-510k.jpg K231604 - Instrument Case K231604 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cochlear Americas. Cleared Aug 2023. https://www.510kdatabase.net/k231680/ 2023-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k231680-accelfix-lumbar-expandable-cage-system-fda-510k.jpg K231680 - AccelFix Lumbar Expandable Cage System K231680 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: L & K Biomed Co., Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k231944/ 2023-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k231944-catamaran-si-joint-fusion-system-fda-510k.jpg K231944 - CATAMARAN SI Joint Fusion System K231944 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tenon Medical, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k232215/ 2023-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k232215-quantra-hemostasis-analyzer-fda-510k.jpg K232215 - Quantra Hemostasis Analyzer K232215 is a FDA 510(k) cleared hematology medical device. Manufacturer: Hemosonics, LLC. Cleared Aug 2023. https://www.510kdatabase.net/k232218/ 2023-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k232218-zenius-spinal-system-fda-510k.jpg K232218 - Zenius™ Spinal System K232218 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medyssey USA, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k232291/ 2023-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k232291-essenz-hlm-essenz-ilbm-fda-510k.jpg K232291 - Essenz HLM, Essenz ILBM K232291 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Livanova Deutschland, GmbH. Cleared Aug 2023. https://www.510kdatabase.net/k222946/ 2023-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k222946-oneday-mini-implant-system-fda-510k.jpg K222946 - Oneday Mini Implant System K222946 is a FDA 510(k) cleared dental medical device. Manufacturer: Oneday Biotech Co., Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k223590/ 2023-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k223590-access-folate-assay-fda-510k.jpg K223590 - Access Folate Assay K223590 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k230079/ 2023-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k230079-polyisoprene-surgical-gloves-tested-fda-510k.jpg K230079 - Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential K230079 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ansell Healthcare Products, LLC. Cleared Aug 2023. https://www.510kdatabase.net/k230610/ 2023-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k230610-disposable-surgical-gown-level-3-fda-510k.jpg K230610 - Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series) K230610 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Dongguan Shin YI Healthcare Products Factory. Cleared Aug 2023. https://www.510kdatabase.net/k230812/ 2023-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k230812-withings-scan-monitor-20-fda-510k.jpg K230812 - Withings Scan Monitor 2.0 K230812 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Withings. Cleared Aug 2023. https://www.510kdatabase.net/k231517/ 2023-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k231517-vitros-immunodiagnostic-products-cea-fda-510k.jpg K231517 - VITROS Immunodiagnostic Products CEA Reagent Pack K231517 is a FDA 510(k) cleared immunology medical device. Manufacturer: Ortho-Clinical Diagnostics. Cleared Aug 2023. https://www.510kdatabase.net/k232243/ 2023-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k232243-evo-700-series-high-speed-handpiece-fda-510k.jpg K232243 - EVO 700 series high speed handpiece K232243 is a FDA 510(k) cleared dental medical device. Manufacturer: Ttbio Corp.. Cleared Aug 2023. https://www.510kdatabase.net/k220938/ 2023-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k220938-nova-hd-fda-510k.jpg K220938 - Nova HD+ K220938 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Aura Wellness, LLC. Cleared Aug 2023. https://www.510kdatabase.net/k223574/ 2023-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k223574-intellivue-patient-monitor-mx400-fda-510k.jpg K223574 - IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 (866064), IntelliVue Patient Monitor MX550 (866066) K223574 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Philips Medizin Systeme Boeblingen GmbH. Cleared Aug 2023. https://www.510kdatabase.net/k230899/ 2023-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k230899-qxr-ptx-pe-fda-510k.jpg K230899 - qXR-PTX-PE K230899 is a FDA 510(k) cleared radiology medical device. Manufacturer: Qure.Ai Technologies. Cleared Aug 2023. https://www.510kdatabase.net/k231205/ 2023-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k231205-gurunanda-dry-mouth-oral-rinse-and-fda-510k.jpg K231205 - GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray K231205 is a FDA 510(k) cleared dental medical device. Manufacturer: Gurunanda, LLC. Cleared Aug 2023. https://www.510kdatabase.net/k231496/ 2023-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k231496-titan-3-d-wedge-system-fda-510k.jpg K231496 - TITAN 3-D Wedge System K231496 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paragon 28, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k231503/ 2023-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k231503-cuptimize-advanced-fda-510k.jpg K231503 - CUPTIMIZE™ Advanced K231503 is a FDA 510(k) cleared radiology medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k231510/ 2023-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k231510-surgical-gown-smlxlxxlxxxl-fda-510k.jpg K231510 - Surgical Gown (S,M,L,XL,XXL,XXXL) K231510 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Xiantao Zhibo Non-Woven Products Co., Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k231811/ 2023-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k231811-zavation-connector-system-fda-510k.jpg K231811 - Zavation Connector System K231811 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zavation Medical Products, LLC. Cleared Aug 2023. https://www.510kdatabase.net/k232190/ 2023-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k232190-6f-sherpa-nx-balanced-guide-catheter-fda-510k.jpg K232190 - 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter K232190 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Aug 2023. https://www.510kdatabase.net/den220052/ 2023-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/den220052-brachygel-vaginal-hydrogel-packing-fda-510k.jpg DEN220052 - BrachyGel Vaginal Hydrogel Packing System DEN220052 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brachyfoam, Inc. D/B/A Advaray. Cleared Aug 2023. https://www.510kdatabase.net/k222245/ 2023-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k222245-acr-screw-system-fda-510k.jpg K222245 - ACR Screw System K222245 is a FDA 510(k) cleared dental medical device. Manufacturer: Biomaterials Korea, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k223560/ 2023-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k223560-plato-17-microcatheter-fda-510k.jpg K223560 - Plato 17 Microcatheter K223560 is a FDA 510(k) cleared neurology medical device. Manufacturer: Scientia Vascular, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k223813/ 2023-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k223813-aveta-system-20-fda-510k.jpg K223813 - Aveta System 2.0 K223813 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Meditrina, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k230486/ 2023-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k230486-cove-strip-fda-510k.jpg K230486 - Cove Strip K230486 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared Aug 2023. https://www.510kdatabase.net/k231266/ 2023-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k231266-pediatric-nailing-platform-tibia-fda-510k.jpg K231266 - Pediatric Nailing Platform Tibia K231266 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OrthoPediatrics Corp.. Cleared Aug 2023. https://www.510kdatabase.net/k231731/ 2023-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k231731-optional-screen-displays-for-heartsee-fda-510k.jpg K231731 - Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4 K231731 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mcgovern Medical School. Cleared Aug 2023. https://www.510kdatabase.net/k231763/ 2023-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k231763-stable-c-interbody-system-fda-510k.jpg K231763 - Stable-C Interbody System K231763 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nexus Spine, LLC. Cleared Aug 2023. https://www.510kdatabase.net/k231867/ 2023-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k231867-grappler-suture-anchor-system-fda-510k.jpg K231867 - Grappler Suture Anchor System K231867 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paragon 28, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k232185/ 2023-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k232185-sm-iv-fda-510k.jpg K232185 - SM-IV K232185 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sedecal., Sa.. Cleared Aug 2023. https://www.510kdatabase.net/k231328/ 2023-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k231328-lux-dx-ii-m302-fda-510k.jpg K231328 - LUX-Dx II (M302) K231328 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Aug 2023. https://www.510kdatabase.net/k220253/ 2023-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k220253-eco-abutment-multiunit-abutment-fda-510k.jpg K220253 - Eco Abutment, Multiunit Abutment K220253 is a FDA 510(k) cleared dental medical device. Manufacturer: Dio Corporation. Cleared Aug 2023. https://www.510kdatabase.net/k222993/ 2023-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k222993-flexylon-surgical-powder-free-gloves-fda-510k.jpg K222993 - Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green Tested For Use with 13 Chemotherapy Drugs K222993 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sentienx Sdn Bhd. Cleared Aug 2023. https://www.510kdatabase.net/k223163/ 2023-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k223163-sleepiz-one-fda-510k.jpg K223163 - Sleepiz One+ K223163 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sleepiz AG. Cleared Aug 2023. https://www.510kdatabase.net/k223526/ 2023-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k223526-allevyn-ag-border-antimicrobial-fda-510k.jpg K223526 - ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Border Sacrum Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Surgical Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing K223526 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew Medical Limited. Cleared Aug 2023. https://www.510kdatabase.net/k223539/ 2023-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k223539-dreem-3s-fda-510k.jpg K223539 - Dreem 3S K223539 is a FDA 510(k) cleared neurology medical device. Manufacturer: Beacon Biosignals, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k223573/ 2023-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k223573-onera-sleep-test-system-onera-sts-fda-510k.jpg K223573 - Onera Sleep Test System (Onera STS) K223573 is a FDA 510(k) cleared neurology medical device. Manufacturer: Onera B.V.. Cleared Aug 2023. https://www.510kdatabase.net/k223867/ 2023-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k223867-ids-acth-ii-fda-510k.jpg K223867 - IDS ACTH II K223867 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Immunodiagnostic Systems Limited. Cleared Aug 2023. https://www.510kdatabase.net/k223883/ 2023-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k223883-daye-tampon-fda-510k.jpg K223883 - Daye Tampon K223883 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Annes Daye, Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k230579/ 2023-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k230579-smart-wedge-algorithm-fda-510k.jpg K230579 - Smart Wedge algorithm K230579 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Aug 2023. https://www.510kdatabase.net/k231026/ 2023-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k231026-12mp-color-lcd-monitor-c1216w-c12-0-to-fda-510k.jpg K231026 - 12MP Color LCD Monitor C1216W, C12*** (* = 0 to 9, A to Z or blank, and the difference among models means the product is named according to different appearance colors and customer models) K231026 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Beacon Display Technology Co., Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k231053/ 2023-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k231053-unicare-k-unicare-usa-fda-510k.jpg K231053 - Unicare (K-UNICARE-USA) K231053 is a FDA 510(k) cleared neurology medical device. Manufacturer: Tenscare, Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k231085/ 2023-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k231085-15t-hd-tr-knee-array-10-f34127-fda-510k.jpg K231085 - 1.5T HD T/R Knee Array (10-F34127) K231085 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen RF Tech Co., Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k231096/ 2023-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k231096-automatic-continuous-effusion-shunt-fda-510k.jpg K231096 - Automatic Continuous Effusion Shunt (ACES) System ACES System K231096 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Pleural Dynamics, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k231204/ 2023-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k231204-cochlear-osia-system-fda-510k.jpg K231204 - Cochlear™ Osia® System K231204 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Cochlear. Cleared Aug 2023. https://www.510kdatabase.net/k231257/ 2023-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k231257-pangea-utility-plating-system-pangea-fda-510k.jpg K231257 - Pangea Utility Plating System, Pangea Platform K231257 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker GmbH. Cleared Aug 2023. https://www.510kdatabase.net/k231262/ 2023-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k231262-pangea-femur-plating-system-pangea-fda-510k.jpg K231262 - Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System K231262 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker GmbH. Cleared Aug 2023. https://www.510kdatabase.net/k231457/ 2023-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k231457-spark-scan-fda-510k.jpg K231457 - SPARK Scan K231457 is a FDA 510(k) cleared neurology medical device. Manufacturer: Spark Neuro, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k231673/ 2023-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k231673-p200te-a10700-fda-510k.jpg K231673 - P200TE (A10700) K231673 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Optos Plc.. Cleared Aug 2023. https://www.510kdatabase.net/k231718/ 2023-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k231718-holmium-medical-laser-fda-510k.jpg K231718 - Holmium Medical Laser K231718 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Allengers Global Healthcare Private Limited. Cleared Aug 2023. https://www.510kdatabase.net/k231777/ 2023-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k231777-electrosurgical-generator-esg-410-and-fda-510k.jpg K231777 - Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W) K231777 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Olympus Winter & Ibe GmbH. Cleared Aug 2023. https://www.510kdatabase.net/k232144/ 2023-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k232144-sterile-products-of-the-aptus-system-fda-510k.jpg K232144 - Sterile Products of the APTUS System K232144 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medartis AG. Cleared Aug 2023. https://www.510kdatabase.net/k232150/ 2023-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k232150-zsfab-cervical-interbody-system-fda-510k.jpg K232150 - ZSFab Cervical Interbody System K232150 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zsfab, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k232153/ 2023-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k232153-avli-fda-510k.jpg K232153 - Avéli K232153 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Revelle Aesthetics, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k232157/ 2023-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k232157-connected-or-hub-with-device-and-voice-fda-510k.jpg K232157 - Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control K232157 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker Corporation. Cleared Aug 2023. https://www.510kdatabase.net/k232498/ 2023-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k232498-ultraseal-xt-plus-bioprotection-by-fda-510k.jpg K232498 - UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio K232498 is a FDA 510(k) cleared dental medical device. Manufacturer: Ultradent Product, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/den230019/ 2023-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/den230019-axios-stent-and-electrocautery-fda-510k.jpg DEN230019 - AXIOS Stent and Electrocautery-Enhanced Delivery System (10mm x 10mm Stent) DEN230019 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Aug 2023. https://www.510kdatabase.net/k222772/ 2023-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k222772-oralenteral-syringe-with-enfit-connector-fda-510k.jpg K222772 - Oral/Enteral Syringe with ENFit connector K222772 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Anhui Tiankang Medical Technology Co., Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k222773/ 2023-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k222773-feeding-tube-fda-510k.jpg K222773 - Feeding Tube K222773 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Anhui Tiankang Medical Technology Co., Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k223167/ 2023-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k223167-spirair-nasal-septal-strap-fda-510k.jpg K223167 - Spirair Nasal Septal Strap K223167 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Spirair, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k223538/ 2023-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k223538-integrity-implant-fda-510k.jpg K223538 - Integrity Implant K223538 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Anika Therapeutics, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k223912/ 2023-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k223912-intercollagen-guide-fda-510k.jpg K223912 - InterCollagen® Guide K223912 is a FDA 510(k) cleared dental medical device. Manufacturer: Sigmagraft, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k230415/ 2023-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k230415-cadwell-guardian-fda-510k.jpg K230415 - Cadwell Guardian K230415 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cadwell Industries, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k230588/ 2023-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k230588-aer-o-scope-colonoscope-system-fda-510k.jpg K230588 - Aer-O-Scope Colonoscope System K230588 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Gi View , Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k230690/ 2023-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k230690-tandry-locking-plate-system-fda-510k.jpg K230690 - Tandry Locking Plate System K230690 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Microware Precision Co., Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k230871/ 2023-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k230871-extron-5-fda-510k.jpg K230871 - EXTRON 5 K230871 is a FDA 510(k) cleared radiology medical device. Manufacturer: DRTECH Corporation. Cleared Aug 2023. https://www.510kdatabase.net/k231481/ 2023-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k231481-xpert-xpress-cov-2flursv-plus-fda-510k.jpg K231481 - Xpert Xpress CoV-2/Flu/RSV plus K231481 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Cepheid. Cleared Aug 2023. https://www.510kdatabase.net/k222148/ 2023-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k222148-hemoscreen-hematology-analyzer-fda-510k.jpg K222148 - HemoScreen Hematology Analyzer K222148 is a FDA 510(k) cleared hematology medical device. Manufacturer: Pixcell Medical Technologies, Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k223479/ 2023-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k223479-aquabase-nx-fda-510k.jpg K223479 - AQUAbase nX K223479 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k223709/ 2023-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k223709-kyphoplasty-balloon-catheter-fda-510k.jpg K223709 - Kyphoplasty Balloon Catheter K223709 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Jiangsu Changmei Medtech Co., Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k223922/ 2023-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k223922-somnum-v112-fda-510k.jpg K223922 - SOMNUM (V.1.1.2.) K223922 is a FDA 510(k) cleared neurology medical device. Manufacturer: Honeynaps Co., Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k230298/ 2023-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k230298-celsi-monitor-fda-510k.jpg K230298 - Celsi Monitor K230298 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hadleigh Health Technologies. Cleared Aug 2023. https://www.510kdatabase.net/k230314/ 2023-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k230314-sterile-powder-free-nitrile-fda-510k.jpg K230314 - Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors) K230314 is a FDA 510(k) cleared general hospital medical device. Manufacturer: New Era Medicare Sdn. Bhd.. Cleared Aug 2023. https://www.510kdatabase.net/k230342/ 2023-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k230342-phototherapy-system-ol-pdt950-fda-510k.jpg K230342 - Phototherapy System (OL-PDT950) K230342 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shanghai Omni Laser Skinology Co., Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k230577/ 2023-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k230577-sterile-triplex-surgical-gown-s-m-l-xl-fda-510k.jpg K230577 - Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL) K230577 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi. Cleared Aug 2023. https://www.510kdatabase.net/k230581/ 2023-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k230581-topa12-portable-x-ray-unit-fda-510k.jpg K230581 - TOPA12 Portable X-ray Unit K230581 is a FDA 510(k) cleared radiology medical device. Manufacturer: Neuf, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k230832/ 2023-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k230832-powdered-free-sterile-natural-rubber-fda-510k.jpg K230832 - Powdered Free Sterile Natural Rubber Latex Surgical Gloves K230832 is a FDA 510(k) cleared general hospital medical device. Manufacturer: The Egyptian Company For Medical & Electronic Industries. Cleared Aug 2023. https://www.510kdatabase.net/k231087/ 2023-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k231087-guided-surgery-kit-fda-510k.jpg K231087 - Guided Surgery Kit K231087 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Implant Direct Sybron Manufacturing, LLC. Cleared Aug 2023. https://www.510kdatabase.net/k231389/ 2023-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k231389-harvest-dental-hd-gum-strip-fda-510k.jpg K231389 - Harvest Dental HD Gum Strip K231389 is a FDA 510(k) cleared dental medical device. Manufacturer: Harvest Dental Products, LLC. Cleared Aug 2023. https://www.510kdatabase.net/k231491/ 2023-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k231491-ta-stapler-and-loading-unit-with-dst-fda-510k.jpg K231491 - TA™ Stapler and Loading Unit with DST Series™ Technology K231491 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien. Cleared Aug 2023. https://www.510kdatabase.net/k232116/ 2023-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k232116-corelink-navigation-instruments-fda-510k.jpg K232116 - CoreLink Navigation Instruments K232116 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corelink, LLC. Cleared Aug 2023. https://www.510kdatabase.net/k232126/ 2023-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k232126-eeacircular-stapler-with-tri-staple-fda-510k.jpg K232126 - EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler Anvil K232126 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien. Cleared Aug 2023. https://www.510kdatabase.net/k232141/ 2023-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k232141-cd-horizon-modulex-fns-screw-set-fda-510k.jpg K232141 - CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw) K232141 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/den220073/ 2023-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/den220073-revi-system-fda-510k.jpg DEN220073 - Revi System DEN220073 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Bluewind Medical , Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k223874/ 2023-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k223874-baroguard-fda-510k.jpg K223874 - BAROguard K223874 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Paragonix Technologies. Cleared Aug 2023. https://www.510kdatabase.net/k231094/ 2023-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k231094-annalise-enterprise-ctb-triage-oh-fda-510k.jpg K231094 - Annalise Enterprise CTB Triage-OH K231094 is a FDA 510(k) cleared radiology medical device. Manufacturer: Annalise-Ai Pty , Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k231301/ 2023-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k231301-vscan-air-fda-510k.jpg K231301 - Vscan Air K231301 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared Aug 2023. https://www.510kdatabase.net/k231455/ 2023-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k231455-implant-one-system-fda-510k.jpg K231455 - Implant-One System K231455 is a FDA 510(k) cleared dental medical device. Manufacturer: Implant Logistics, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k231583/ 2023-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k231583-route-92-medical-full-length-054-fda-510k.jpg K231583 - Route 92 Medical Full Length 054 Access System K231583 is a FDA 510(k) cleared neurology medical device. Manufacturer: Route 92 Medical, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k231750/ 2023-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k231750-ma012-aluminum-wheelchair-ms019-steel-fda-510k.jpg K231750 - MA012 Aluminum wheelchair, MS019 steel wheelchair K231750 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Sichuan Ast Medical Equipment Co., Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k231807/ 2023-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k231807-primalok-sp-interspinous-fusion-system-fda-510k.jpg K231807 - primaLOK™ SP Interspinous Fusion System K231807 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wenzel Spine, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k231829/ 2023-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k231829-xenix-medical-sacroiliac-fixation-system-fda-510k.jpg K231829 - Xenix Medical Sacroiliac Fixation System K231829 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ht Medical D.B.A. Xenix Medical. Cleared Aug 2023. https://www.510kdatabase.net/k231838/ 2023-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k231838-rxsight-insertion-device-63002-fda-510k.jpg K231838 - RxSight® Insertion Device (63002) K231838 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Rxsight, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k232127/ 2023-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k232127-21hq513d-32hl512d-31hn713d-32hq713d-fda-510k.jpg K232127 - 21HQ513D, 32HL512D, 31HN713D, 32HQ713D K232127 is a FDA 510(k) cleared radiology medical device. Manufacturer: Lg Electronics.Inc. Cleared Aug 2023. https://www.510kdatabase.net/k223660/ 2023-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k223660-saintview-fda-510k.jpg K223660 - SaintView K223660 is a FDA 510(k) cleared radiology medical device. Manufacturer: Inviz Corporation. Cleared Aug 2023. https://www.510kdatabase.net/k230607/ 2023-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k230607-spicca-cervical-fusion-cages-fda-510k.jpg K230607 - SPICCA Cervical Fusion Cages K230607 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Southern Medical (Pty) , Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k230608/ 2023-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k230608-spicca-stand-alone-cervical-fusion-cages-fda-510k.jpg K230608 - SPICCA Stand-Alone Cervical Fusion Cages K230608 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Southern Medical (Pty) , Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k230663/ 2023-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k230663-density-fda-510k.jpg K230663 - Density K230663 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Jeisys Medical, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k231018/ 2023-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k231018-yomi-robotic-system-fda-510k.jpg K231018 - Yomi Robotic System K231018 is a FDA 510(k) cleared dental medical device. Manufacturer: Neocis, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k231054/ 2023-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k231054-v-laser-fda-510k.jpg K231054 - V-Laser K231054 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wontech Co., Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k231208/ 2023-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k231208-stryker-resorbable-fixation-system-fda-510k.jpg K231208 - Stryker Resorbable Fixation System K231208 is a FDA 510(k) cleared neurology medical device. Manufacturer: Stryker Leibinger GmbH & Co KG. Cleared Aug 2023. https://www.510kdatabase.net/k231341/ 2023-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k231341-organic-cotton-tampon-viscose-tampon-fda-510k.jpg K231341 - Organic cotton tampon, Viscose tampon K231341 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Zhejiang Tianqing Manufacturing Technology Group Co., Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k231418/ 2023-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k231418-endogator-hybrid-irrigation-tubing-fda-510k.jpg K231418 - ENDOGATOR™ Hybrid Irrigation Tubing K231418 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medivators. Cleared Aug 2023. https://www.510kdatabase.net/k231434/ 2023-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k231434-dess-dental-smart-solutions-fda-510k.jpg K231434 - DESS Dental Smart Solutions K231434 is a FDA 510(k) cleared dental medical device. Manufacturer: Terrats Medical SL. Cleared Aug 2023. https://www.510kdatabase.net/k231905/ 2023-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k231905-electro-spec-steri-caps-fda-510k.jpg K231905 - Electro-Spec Steri-Caps K231905 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Electro-Spec, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k232162/ 2023-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k232162-autotome-pro-rx-39-sphincterotome-fda-510k.jpg K232162 - Autotome Pro RX 39 Sphincterotome K232162 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Aug 2023. https://www.510kdatabase.net/k232311/ 2023-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k232311-lnk-spinal-fixation-system-openloc-l-fda-510k.jpg K232311 - LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System K232311 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: L & K Biomed Co., Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k223584/ 2023-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k223584-pre-filled-normal-saline-flush-syringe-fda-510k.jpg K223584 - Pre-Filled Normal Saline Flush Syringe K223584 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Anhui Tianyang Pharmaceutical Co., Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k230172/ 2023-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k230172-pulse-oximeter-fda-510k.jpg K230172 - Pulse Oximeter K230172 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Beijing Choice Electronic Technology Co., Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k230756/ 2023-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k230756-tk-pre-filled-normal-saline-flush-fda-510k.jpg K230756 - TK Pre-Filled Normal Saline Flush Syringe K230756 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Anhui Tiankang Medical Technology Co., Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k222888/ 2023-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k222888-bluestar-cgm-insulin-dose-calculator-fda-510k.jpg K222888 - BlueStar CGM insulin dose calculator K222888 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Welldoc, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k223463/ 2023-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k223463-otsuka-digital-feedback-device-rw-fda-510k.jpg K223463 - Otsuka Digital Feedback Device-RW K223463 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Otsuka America Pharmaceutical, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k223519/ 2023-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k223519-carex-hybrid-personal-lubricant-fda-510k.jpg K223519 - Carex Hybrid Personal Lubricant K223519 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Karex Industries Sdn. Bhd.. Cleared Aug 2023. https://www.510kdatabase.net/k223840/ 2023-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k223840-erapid-nebulizer-system-fda-510k.jpg K223840 - eRapid Nebulizer System K223840 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Pari Respiratory Equipment, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k223856/ 2023-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k223856-nuera-tight-rf-family-fda-510k.jpg K223856 - NuEra Tight RF Family K223856 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bios S.R.L.. Cleared Aug 2023. https://www.510kdatabase.net/k230297/ 2023-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k230297-pmt-expandable-cage-pmt-exp-fda-510k.jpg K230297 - PMT Expandable Cage (PMT EXP) K230297 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Providence Medical Technology, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k230384/ 2023-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k230384-polywear-personal-protective-level-3-fda-510k.jpg K230384 - PolyWear® Personal Protective Level 3 Gown K230384 is a FDA 510(k) cleared general hospital medical device. Manufacturer: PolyConversions, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k230420/ 2023-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k230420-dr-pen-microneedling-system-fda-510k.jpg K230420 - Dr. pen Microneedling System K230420 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Guangzhou Ekai Electronic Technology Co., Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k230626/ 2023-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k230626-portrait-central-viewer-application-fda-510k.jpg K230626 - Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services (Portrait CSS01), Portrait™ Clinical Alarming Unit (Portrait CAU01) K230626 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Ge Medical Systems Information Technologies, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k230632/ 2023-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k230632-versihd-with-guideme-software-fda-510k.jpg K230632 - VersiHD with GuideMe software K230632 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Nxstage Medical, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k230642/ 2023-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k230642-electronic-blood-pressure-monitor-fda-510k.jpg K230642 - Electronic Blood Pressure Monitor K230642 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Dongguan Kangweile Electronic Technology Co., Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k231408/ 2023-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k231408-basic-synguard-nitrile-exam-gloves-fda-510k.jpg K231408 - Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile K231408 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shandong Intco Medical Products Co, Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k231409/ 2023-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k231409-erchonia-fx-405-fda-510k.jpg K231409 - Erchonia FX-405 K231409 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Erchonia Corporation. Cleared Aug 2023. https://www.510kdatabase.net/k231439/ 2023-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k231439-powder-free-white-black-and-purple-fda-510k.jpg K231439 - Powder Free White, Black, and Purple Nitrile Examination Glove K231439 is a FDA 510(k) cleared general hospital medical device. Manufacturer: S&S Glove Corporation. Cleared Aug 2023. https://www.510kdatabase.net/k231493/ 2023-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k231493-nitinex-memory-compression-staple-fda-510k.jpg K231493 - NITINEX Memory Compression Staple K231493 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Vilex, LLC. Cleared Aug 2023. https://www.510kdatabase.net/k231696/ 2023-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k231696-fusion-bond-5-fusion-bond-7-fusion-fda-510k.jpg K231696 - Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal K231696 is a FDA 510(k) cleared dental medical device. Manufacturer: Prevest Denpro Limited. Cleared Aug 2023. https://www.510kdatabase.net/k231823/ 2023-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k231823-noxboxi-nitric-oxide-delivery-system-fda-510k.jpg K231823 - NOxBOXi Nitric Oxide Delivery System K231823 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Linde Gas & Equipment, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k213131/ 2023-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k213131-accu-chek-guide-solo-diabetes-manager-fda-510k.jpg K213131 - Accu-Chek Guide Solo diabetes manager blood glucose monitoring system K213131 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diabetes Care GmbH. Cleared Aug 2023. https://www.510kdatabase.net/k213134/ 2023-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k213134-accu-chek-solo-micropump-system-with-fda-510k.jpg K213134 - Accu-Chek Solo micropump system with interoperable technology K213134 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diabetes Care GmbH. Cleared Aug 2023. https://www.510kdatabase.net/k221925/ 2023-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k221925-id-now-covid-19-20-fda-510k.jpg K221925 - ID NOW COVID-19 2.0 K221925 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Diagnostics Scarborough, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k222850/ 2023-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k222850-havab-igg-ii-fda-510k.jpg K222850 - HAVAb IgG II K222850 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Aug 2023. https://www.510kdatabase.net/k223445/ 2023-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k223445-artifascia-fda-510k.jpg K223445 - ArtiFascia K223445 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nurami Medical , Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k223500/ 2023-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k223500-superball-meniscal-repair-system-fda-510k.jpg K223500 - SuperBall Meniscal Repair System K223500 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Arcuro Medical , Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k223608/ 2023-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k223608-gem-premier-7000-with-iqm3-fda-510k.jpg K223608 - GEM Premier 7000 with IQM3 K223608 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory Company. Cleared Aug 2023. https://www.510kdatabase.net/k223711/ 2023-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k223711-anne-one-fda-510k.jpg K223711 - ANNE One K223711 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sibel Health, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k230268/ 2023-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k230268-zenpro-40-fda-510k.jpg K230268 - ZenPro 40 K230268 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: BLUECORE COMPANY Co., Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k230428/ 2023-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k230428-ambu-ascope-5-broncho-2712-ambu-ascope-fda-510k.jpg K230428 - Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aBox™ 2 K230428 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Ambu A/S. Cleared Aug 2023. https://www.510kdatabase.net/k230625/ 2023-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k230625-relion-premier-blu-blood-glucose-fda-510k.jpg K230625 - ReliOn Premier BLU Blood Glucose Monitoring System K230625 is a FDA 510(k) cleared chemistry medical device. Manufacturer: I-Sens, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k231380/ 2023-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k231380-airlife-duotherm-humidification-system-fda-510k.jpg K231380 - AirLife DuoTherm™ Humidification System K231380 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Vyaire Medical, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k231415/ 2023-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k231415-ensite-x-ep-system-fda-510k.jpg K231415 - EnSite™ X EP System K231415 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared Aug 2023. https://www.510kdatabase.net/k231420/ 2023-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k231420-aura-10-petct-fda-510k.jpg K231420 - Aura 10 PET/CT K231420 is a FDA 510(k) cleared radiology medical device. Manufacturer: Xeos Medical. Cleared Aug 2023. https://www.510kdatabase.net/k222443/ 2023-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k222443-air-smart-extra-spirometer-fda-510k.jpg K222443 - Air Smart Extra Spirometer K222443 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Feellife Health, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k230304/ 2023-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k230304-polyisoprene-surgical-gloves-fda-510k.jpg K230304 - Polyisoprene Surgical Gloves K230304 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Puyang Linshi Medical Supplies Co., Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k231114/ 2023-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k231114-zimmer-natural-nail-system-fda-510k.jpg K231114 - Zimmer® Natural Nail® System Cephalomedullary Nails K231114 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer Switzerland Manufacturing GmbH. Cleared Aug 2023. https://www.510kdatabase.net/k231164/ 2023-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k231164-conductive-carbon-film-electrode-fda-510k.jpg K231164 - Conductive carbon film electrode K231164 is a FDA 510(k) cleared neurology medical device. Manufacturer: Guangzhou Xinbo Electronic Co., Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k231167/ 2023-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k231167-conductive-silicone-rubber-electrode-fda-510k.jpg K231167 - Conductive Silicone Rubber Electrode K231167 is a FDA 510(k) cleared neurology medical device. Manufacturer: Guangzhou Xinbo Electronic Co., Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k231376/ 2023-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k231376-q-fix-with-needles-q-fix-with-needles-fda-510k.jpg K231376 - Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape) K231376 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k231394/ 2023-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k231394-intense-pulsed-light-system-fda-510k.jpg K231394 - Intense Pulsed Light System K231394 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smedtrum Medical Technology Co., Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k231525/ 2023-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k231525-vitros-immunodiagnostic-products-ca-19-fda-510k.jpg K231525 - VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack K231525 is a FDA 510(k) cleared immunology medical device. Manufacturer: Ortho-Clinical Diagnostics. Cleared Aug 2023. https://www.510kdatabase.net/k231885/ 2023-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k231885-medline-unite-reflex-nitinol-staple-fda-510k.jpg K231885 - Medline UNITE® REFLEX® Nitinol Staple System K231885 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medline Industries, LP. Cleared Aug 2023. https://www.510kdatabase.net/k232039/ 2023-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k232039-sterile-powder-free-nitrile-fda-510k.jpg K232039 - Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate K232039 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Grand Work Plastic Products Co., Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k222128/ 2023-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k222128-protective-gown-aami-level-4-fda-510k.jpg K222128 - Protective Gown AAMI Level 4 K222128 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Kenpax International Limited. Cleared Aug 2023. https://www.510kdatabase.net/k222439/ 2023-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k222439-atellica-ch-phencyclidine-pcp-atellica-fda-510k.jpg K222439 - Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc) K222439 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k223633/ 2023-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k223633-rubicon-control-support-catheter-fda-510k.jpg K223633 - Rubicon™ Control Support Catheter (H749394323506A1) K223633 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Aug 2023. https://www.510kdatabase.net/k223924/ 2023-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k223924-lw-implant-system-fda-510k.jpg K223924 - LW Implant System K223924 is a FDA 510(k) cleared dental medical device. Manufacturer: Ossvis Co., Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k230551/ 2023-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k230551-visual-ice-cryoablation-system-fda-510k.jpg K230551 - Visual-ICE Cryoablation System K230551 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Boston Scientific Corporation. Cleared Aug 2023. https://www.510kdatabase.net/k230620/ 2023-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k230620-gentuity-hf-oct-imaging-system-with-fda-510k.jpg K230620 - Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter K230620 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Gentuity, LLC. Cleared Aug 2023. https://www.510kdatabase.net/k231857/ 2023-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k231857-arthrex-tightrope-ii-fda-510k.jpg K231857 - Arthrex TightRope II K231857 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k232008/ 2023-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k232008-disposable-medical-examination-nitrile-fda-510k.jpg K232008 - Disposable Medical Examination Nitrile Gloves K232008 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Raxwell Industrial, LLC. Cleared Aug 2023. https://www.510kdatabase.net/k232052/ 2023-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k232052-ceribell-instant-eeg-headband-fda-510k.jpg K232052 - Ceribell Instant EEG Headband K232052 is a FDA 510(k) cleared neurology medical device. Manufacturer: Ceribell, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k232100/ 2023-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k232100-efai-pacs-picture-archiving-and-fda-510k.jpg K232100 - Efai Pacs Picture Archiving and Communication System Pro K232100 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ever Fortune.Ai, Co., Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k220828/ 2023-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k220828-sqa-io-sperm-quality-analyzer-fda-510k.jpg K220828 - SQA-iO Sperm Quality Analyzer K220828 is a FDA 510(k) cleared hematology medical device. Manufacturer: Medical Electronic Systems , Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k223476/ 2023-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k223476-v-pro-max-2-low-temperature-fda-510k.jpg K223476 - V-PRO maX 2 Low Temperature Sterilization System K223476 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Aug 2023. https://www.510kdatabase.net/k223713/ 2023-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k223713-powder-free-nitrile-examination-glove-fda-510k.jpg K223713 - Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate K223713 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Better Care Plastic Technology Co., Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k230376/ 2023-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k230376-reprocessed-agilis-nxt-steerable-fda-510k.jpg K230376 - Reprocessed Agilis NxT Steerable Introducer K230376 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Innovative Health, LLC. Cleared Aug 2023. https://www.510kdatabase.net/k231098/ 2023-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k231098-linesider-spinal-system-fda-510k.jpg K231098 - LineSider® Spinal System K231098 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Integrity Implants, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k231488/ 2023-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k231488-celerity-hp-chemical-indicator-fda-510k.jpg K231488 - Celerity™ HP Chemical Indicator K231488 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Steris. Cleared Aug 2023. https://www.510kdatabase.net/k231490/ 2023-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k231490-celerity-20-hp-biological-indicator-fda-510k.jpg K231490 - Celerity 20 HP Biological Indicator K231490 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Aug 2023. https://www.510kdatabase.net/k231500/ 2023-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k231500-vis-u-all-low-temperature-fda-510k.jpg K231500 - Vis-U-All Low Temperature Sterilization Pouches K231500 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Aug 2023. https://www.510kdatabase.net/k231501/ 2023-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k231501-pro-lite-sterilization-tray-fda-510k.jpg K231501 - PRO-LITE Sterilization Tray K231501 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Aug 2023. https://www.510kdatabase.net/k230733/ 2023-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k230733-stryker-resorbable-fixation-system-fda-510k.jpg K230733 - Stryker Resorbable Fixation System K230733 is a FDA 510(k) cleared dental medical device. Manufacturer: Stryker Leibinger GmbH & Co KG. Cleared Aug 2023. https://www.510kdatabase.net/k220031/ 2023-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k220031-alinity-h-series-system-fda-510k.jpg K220031 - Alinity h-series System K220031 is a FDA 510(k) cleared hematology medical device. Manufacturer: Abbott Laboratories. Cleared Aug 2023. https://www.510kdatabase.net/k221138/ 2023-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k221138-titus-titanium-cervical-by-sagico-fda-510k.jpg K221138 - Titus Titanium Cervical by SAGICO K221138 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Sagico VA USA, LLC. Cleared Aug 2023. https://www.510kdatabase.net/k222635/ 2023-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k222635-premier-resolution-system-fda-510k.jpg K222635 - Premier Resolution System K222635 is a FDA 510(k) cleared hematology medical device. Manufacturer: Trinity Biotech (Primus Corporation, Dba Trinity Biotech). Cleared Aug 2023. https://www.510kdatabase.net/k223431/ 2023-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k223431-citric-complete-liquid-citric-acid-fda-510k.jpg K223431 - Citric Complete Liquid Citric Acid Concentrate K223431 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Nipro Renal Solutions USA, Corp.. Cleared Aug 2023. https://www.510kdatabase.net/k223507/ 2023-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k223507-cl-dp40-drs-light-prime-cl-dp40-drs-fda-510k.jpg K223507 - CL-DP40 (Dr’s Light PRIME), CL-DP40 (Dr’s Light CHOICE) K223507 is a FDA 510(k) cleared dental medical device. Manufacturer: Good Doctors Co., Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k223673/ 2023-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k223673-surgeon-controlled-arm-fda-510k.jpg K223673 - Surgeon Controlled Arm K223673 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Levita Magnetics International Corp. Cleared Aug 2023. https://www.510kdatabase.net/k223787/ 2023-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k223787-ecgenius-system-fda-510k.jpg K223787 - ECGenius System K223787 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cath Vision Aps. Cleared Aug 2023. https://www.510kdatabase.net/k230126/ 2023-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k230126-dentis-s-clean-regular-abutment-fda-510k.jpg K230126 - Dentis s-Clean Regular Abutment K230126 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentis Co., Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k230672/ 2023-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k230672-annabella-breast-pump-fda-510k.jpg K230672 - Annabella Breast Pump K230672 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Annabella , Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k231333/ 2023-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k231333-stretto-cable-system-fda-510k.jpg K231333 - STRETTO™ Cable System K231333 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k231370/ 2023-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k231370-dewin-blastocyst-medium-with-hsa-and-fda-510k.jpg K231370 - Dewin Blastocyst Medium (with HSA and without HSA) K231370 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Donnevie Medical Technology (Shanghai) Co. , Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k231400/ 2023-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k231400-bladeless-trocar-artemis-lap-cannula-fda-510k.jpg K231400 - Bladeless Trocar – Artemis Lap Cannula K231400 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: T.A.G. Medical Products Corporation, Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k231404/ 2023-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k231404-t-button-a-adjustable-loop-uhmwpe-fda-510k.jpg K231404 - T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button K231404 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Healthium Medtech Limited. Cleared Aug 2023. https://www.510kdatabase.net/k232005/ 2023-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k232005-healicoil-pk-suture-anchor-with-fda-510k.jpg K232005 - HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue) K232005 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k232006/ 2023-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k232006-legacy-ipc-fda-510k.jpg K232006 - LEGACY® IPC K232006 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ig Technology, Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k232010/ 2023-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k232010-itempshield-fda-510k.jpg K232010 - iTEMPSHIELD K232010 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Aion Biosystems, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k221894/ 2023-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k221894-lumbar-expandable-lnterbody-spacers-fda-510k.jpg K221894 - Lumbar Expandable lnterbody Spacers -Additional Indications/Implants K221894 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k223122/ 2023-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k223122-menix-fda-510k.jpg K223122 - MENIX® K223122 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: S.B.M. Sas (Science & Bio Materials). Cleared Aug 2023. https://www.510kdatabase.net/k223133/ 2023-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k223133-visirad-xr-fda-510k.jpg K223133 - VisiRad XR K223133 is a FDA 510(k) cleared radiology medical device. Manufacturer: Imidex, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k223542/ 2023-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k223542-tubavent-balloon-dilatation-system-fda-510k.jpg K223542 - TubaVent Balloon Dilatation System K223542 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Spiggle & Theis Medizintechnik GmbH. Cleared Aug 2023. https://www.510kdatabase.net/k223551/ 2023-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k223551-sterile-water-for-inhalation-in-1l-fda-510k.jpg K223551 - Sterile Water for Inhalation in 1L Flexoval ® bottles. K223551 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Hometa, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k230380/ 2023-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k230380-surgical-face-masks-model-efmds-l50pn-fda-510k.jpg K230380 - Surgical Face Masks, Model: EFMDS-L50Pn BLU K230380 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Iris USA. Cleared Aug 2023. https://www.510kdatabase.net/k230419/ 2023-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k230419-sequel-tampon-with-plastic-applicator-fda-510k.jpg K230419 - Sequel Tampon with Plastic Applicator K230419 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Tampro, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k231458/ 2023-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k231458-extremity-staple-fda-510k.jpg K231458 - Extremity Staple K231458 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Restor3d. Cleared Aug 2023. https://www.510kdatabase.net/k231548/ 2023-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k231548-medical-diode-laser-model-s1pro-fda-510k.jpg K231548 - Medical Diode Laser, Model S1Pro K231548 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wuhan Pioon Technology Co., Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k231654/ 2023-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k231654-northstar-oct-system-fda-510k.jpg K231654 - NorthStar OCT System K231654 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Seaspine, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k231831/ 2023-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k231831-tilink-l-joint-fusion-system-fda-510k.jpg K231831 - TiLink-L Joint Fusion System K231831 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Surgentec. Cleared Aug 2023. https://www.510kdatabase.net/k232015/ 2023-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k232015-atmos-scope-50770000-fda-510k.jpg K232015 - ATMOS Scope (507.7000.0) K232015 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Atmos Medizintechnik GmbH & Co. KG. Cleared Aug 2023. https://www.510kdatabase.net/k232058/ 2023-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k232058-yosemiteview-4343wyosemiteview-3643w-fda-510k.jpg K232058 - YosemiteView 4343W/YosemiteView 3643W K232058 is a FDA 510(k) cleared radiology medical device. Manufacturer: Careray Digital Medical Technology Co., Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k232132/ 2023-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k232132-lifesparc-system-fda-510k.jpg K232132 - LifeSPARC System K232132 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cardiacassist, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/den230003/ 2023-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/den230003-viz-hcm-fda-510k.jpg DEN230003 - Viz HCM DEN230003 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Viz. Ai, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k221114/ 2023-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k221114-immunoglobulin-g-igg-fda-510k.jpg K221114 - Immunoglobulin G (IgG) K221114 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k223114/ 2023-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k223114-suture-anchors-hta-headless-titanium-fda-510k.jpg K223114 - Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors K223114 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Gm Dos Reis Industria E Comerico Ltda.. Cleared Aug 2023. https://www.510kdatabase.net/k223553/ 2023-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k223553-spine-planning-20-elements-spine-fda-510k.jpg K223553 - Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine K223553 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Brainlab AG. Cleared Aug 2023. https://www.510kdatabase.net/k223689/ 2023-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k223689-disposable-needle-guides-and-grids-fda-510k.jpg K223689 - Disposable Needle Guides and Grids K223689 is a FDA 510(k) cleared radiology medical device. Manufacturer: Advance Medical Designs, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k223821/ 2023-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k223821-self-cath-closed-system-fda-510k.jpg K223821 - Self-Cath Closed System K223821 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Coloplast. Cleared Aug 2023. https://www.510kdatabase.net/k230613/ 2023-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k230613-skeeper-fda-510k.jpg K230613 - SKEEPER K230613 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Smartsound Corporation. Cleared Aug 2023. https://www.510kdatabase.net/k230748/ 2023-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k230748-disposable-ureteral-access-sheath-fda-510k.jpg K230748 - Disposable Ureteral Access Sheath K230748 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Youcare Technology Co.,Ltd. (Wuhan). Cleared Aug 2023. https://www.510kdatabase.net/k231126/ 2023-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k231126-eblator-device-fda-510k.jpg K231126 - Eblator Device K231126 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: E Surgical, LLC. Cleared Aug 2023. https://www.510kdatabase.net/k231174/ 2023-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k231174-bpbio750-fda-510k.jpg K231174 - BPBIO750 K231174 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inbody Co., Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k231286/ 2023-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k231286-chemfort-catheter-adaptor-fda-510k.jpg K231286 - Chemfort® Catheter Adaptor K231286 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Simplivia Healthcare , Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k231344/ 2023-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k231344-activsight-intraoperative-imaging-system-fda-510k.jpg K231344 - ActivSight Intraoperative Imaging System K231344 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Activ Surgical, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k231593/ 2023-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k231593-sapphire-x3-anterior-cervical-plate-fda-510k.jpg K231593 - Sapphire X3 Anterior Cervical Plate System K231593 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinal Elements, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k231942/ 2023-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k231942-mineral-collagen-composite-bioactive-fda-510k.jpg K231942 - Mineral Collagen Composite Bioactive Extra Moldable K231942 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Collagen Matrix, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k232030/ 2023-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k232030-ingenia-elition-r571-sp4-mr-systems-fda-510k.jpg K232030 - Ingenia Elition R5.7.1 SP4 MR Systems K232030 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Aug 2023. https://www.510kdatabase.net/k230162/ 2023-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k230162-uct-760-with-uws-ct-dual-energy-fda-510k.jpg K230162 - uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis K230162 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k230873/ 2023-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k230873-angulated-screw-channel-asc-solution-fda-510k.jpg K230873 - Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments K230873 is a FDA 510(k) cleared dental medical device. Manufacturer: Southern Implants (Pty), Ltd.. Cleared Aug 2023. https://www.510kdatabase.net/k231278/ 2023-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k231278-knotless-suture-anchor-fda-510k.jpg K231278 - Knotless Suture Anchor K231278 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Riverpoint Medical, LLC. Cleared Aug 2023. https://www.510kdatabase.net/k231602/ 2023-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k231602-protego-air-water-connector-fda-510k.jpg K231602 - Protego Air Water Connector K231602 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ga Health Company Limited. Cleared Aug 2023. https://www.510kdatabase.net/k231620/ 2023-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k231620-nuubo-smart-fda-510k.jpg K231620 - Nuubo Smart K231620 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Smart Solutions Technologies SL. Cleared Aug 2023. https://www.510kdatabase.net/k231954/ 2023-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k231954-aristotle-18-guidewire-fda-510k.jpg K231954 - Aristotle 18 Guidewire K231954 is a FDA 510(k) cleared neurology medical device. Manufacturer: Scientia Vascular, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k231959/ 2023-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k231959-expd-4357-fda-510k.jpg K231959 - EXPD 4357 K231959 is a FDA 510(k) cleared radiology medical device. Manufacturer: DRTECH Corporation. Cleared Aug 2023. https://www.510kdatabase.net/k231963/ 2023-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k231963-real-intelligence-cori-fda-510k.jpg K231963 - REAL INTELLIGENCE™ CORI™ K231963 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Blue Belt Technologies, Inc.. Cleared Aug 2023. https://www.510kdatabase.net/k221767/ 2023-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k221767-surgical-sutures-with-or-without-needle-fda-510k.jpg K221767 - Surgical Sutures with or without Needle K221767 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Huaian Seamen Medical Technology Co., Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k223097/ 2023-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k223097-renanav-ureteroscope-system-fda-510k.jpg K223097 - RenaNav Ureteroscope System K223097 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: CenterPoint Systems, LLC. Cleared Jul 2023. https://www.510kdatabase.net/k223567/ 2023-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k223567-cns-2101-central-monitor-fda-510k.jpg K223567 - CNS-2101 Central Monitor K223567 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden Corporation. Cleared Jul 2023. https://www.510kdatabase.net/k230004/ 2023-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k230004-disposable-hemoclip-fda-510k.jpg K230004 - Disposable Hemoclip K230004 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Yangzhou Fartley Medical Instrument Technology Co., Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k230630/ 2023-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k230630-zenex-implant-systemnarrow-fda-510k.jpg K230630 - ZENEX Implant System_Narrow K230630 is a FDA 510(k) cleared dental medical device. Manufacturer: Izenimplant Co., Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k230858/ 2023-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k230858-quatera-700-fda-510k.jpg K230858 - QUATERA 700 K230858 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Carl Zeiss Meditec, AG. Cleared Jul 2023. https://www.510kdatabase.net/k230956/ 2023-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k230956-bd-respiratory-viral-panel-for-bd-max-fda-510k.jpg K230956 - BD Respiratory Viral Panel for BD MAX™ System K230956 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Integrated Diagnostic Solutions /. Cleared Jul 2023. https://www.510kdatabase.net/k231321/ 2023-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k231321-nooance-led-and-laser-helmet-fda-510k.jpg K231321 - Nooance Led And Laser Helmet K231321 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Kaiyan Medical Equipment Co., Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k231591/ 2023-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k231591-v-print-cb-temp-fda-510k.jpg K231591 - V-Print c&b temp K231591 is a FDA 510(k) cleared dental medical device. Manufacturer: Voco GmbH. Cleared Jul 2023. https://www.510kdatabase.net/k231613/ 2023-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k231613-intense-pulsed-light-device-models-fda-510k.jpg K231613 - Intense pulsed light device, Model(s): DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G. K231613 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Zhuzhou Goldenhot Medical Technology Co., Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k231698/ 2023-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k231698-alltest-fentanyl-rapid-test-urine-fda-510k.jpg K231698 - AllTest Fentanyl Rapid Test (Urine) K231698 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Hangzhou AllTest Biotech Co., Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k232088/ 2023-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k232088-altris-ims-fda-510k.jpg K232088 - Altris IMS K232088 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Altris, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k222862/ 2023-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k222862-silkpro-titanium-diode-laser-system-fda-510k.jpg K222862 - SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWC K222862 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lotuxs Medtech (Suzhou) Co., Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k222587/ 2023-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k222587-patcom-distal-chip-endoscope-fda-510k.jpg K222587 - PatCom Distal Chip Endoscope K222587 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: H&A Mui Enterprises, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k222735/ 2023-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k222735-hjy-visualnext-endoscopic-vision-system-fda-510k.jpg K222735 - HJY VisualNext Endoscopic Vision System K222735 is a FDA 510(k) cleared neurology medical device. Manufacturer: Hjy Smart Medical Device Co., Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k222794/ 2023-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k222794-flowstar-touch-digital-mixer-flowmeter-fda-510k.jpg K222794 - FlowStar Touch Digital Mixer Flowmeter K222794 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Baldus Sedation GmbH & Co. KG. Cleared Jul 2023. https://www.510kdatabase.net/k222902/ 2023-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k222902-electrocardiograph-se-1200-pro-and-se-fda-510k.jpg K222902 - Electrocardiograph: SE-1200 Pro and SE-1201 Pro K222902 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edan Instruments, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k223670/ 2023-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k223670-mesi-mtablet-ecg-diagnostic-system-fda-510k.jpg K223670 - MESI mTablet ECG Diagnostic System, MESI mTablet ECG K223670 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O.. Cleared Jul 2023. https://www.510kdatabase.net/k223710/ 2023-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k223710-i-stat-cg8-cartridge-with-the-i-stat-1-fda-510k.jpg K223710 - i-STAT CG8+ cartridge with the i-STAT 1 System K223710 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Point of Care, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k223781/ 2023-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k223781-quantisal-ii-oral-fluid-collection-fda-510k.jpg K223781 - Quantisal™ II Oral Fluid Collection Device K223781 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Immunalysis Corporation. Cleared Jul 2023. https://www.510kdatabase.net/k230801/ 2023-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k230801-pathfinder-endoscope-overtube-with-fda-510k.jpg K230801 - Pathfinder Endoscope Overtube with Balloon Device K230801 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Neptune Medical, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k230813/ 2023-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k230813-bluestar-and-bluestar-rx-fda-510k.jpg K230813 - BlueStar and BlueStar Rx K230813 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Welldoc, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k230898/ 2023-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k230898-fluobeam-lx-red-fda-510k.jpg K230898 - FLUOBEAM® LX Red K230898 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Fluoptics Sas. Cleared Jul 2023. https://www.510kdatabase.net/k231073/ 2023-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k231073-skinstylus-sterilock-microsystem-model-fda-510k.jpg K231073 - SkinStylus SteriLock® MicroSystem, Model Number MP1209SL K231073 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Esthetic Medical, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k231249/ 2023-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k231249-pentax-medical-video-processor-epk-fda-510k.jpg K231249 - PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL K231249 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Pentax of America, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k231313/ 2023-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k231313-therapy-mask-3100-ncsp-fda-510k.jpg K231313 - Therapy Mask 3100 NC/SP K231313 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k231480/ 2023-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k231480-bright-mta-sealer-plus-fda-510k.jpg K231480 - Bright MTA Sealer Plus K231480 is a FDA 510(k) cleared dental medical device. Manufacturer: Genoss Co., Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k231552/ 2023-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k231552-dia-cem-fda-510k.jpg K231552 - Dia-Cem K231552 is a FDA 510(k) cleared dental medical device. Manufacturer: DiaDent Group International. Cleared Jul 2023. https://www.510kdatabase.net/k231589/ 2023-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k231589-blood-tubing-lines-for-hemodialysis-fda-510k.jpg K231589 - Blood Tubing Lines for Hemodialysis AV06C-E K231589 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: NIKKISO CO., LTD.. Cleared Jul 2023. https://www.510kdatabase.net/k231618/ 2023-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k231618-3-layer-surgical-mask-134252531-fda-510k.jpg K231618 - 3 Layer Surgical Mask (134252531) K231618 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Original Mattress Factory, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k231931/ 2023-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k231931-adena-zina-spinal-system-fda-510k.jpg K231931 - Adena-Zina Spinal System K231931 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Shanghai Sanyou Medical Co, Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k231951/ 2023-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k231951-si-cure-sacroiliac-joint-fusion-system-fda-510k.jpg K231951 - SI-Cure Sacroiliac Joint Fusion System K231951 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alevio, LLC. Cleared Jul 2023. https://www.510kdatabase.net/k212077/ 2023-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k212077-teleflex-rusch-softsimplastic-foley-fda-510k.jpg K212077 - Teleflex Rusch SoftSimplastic Foley Catheters K212077 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Teleflexmedical, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k223591/ 2023-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k223591-cobas-sars-cov-2-influenza-ab-nucleic-fda-510k.jpg K223591 - cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System K223591 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Molecular Systems, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k230074/ 2023-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k230074-rapid-aneurysm-triage-and-notification-fda-510k.jpg K230074 - Rapid Aneurysm Triage and Notification K230074 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ischemaview, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k230838/ 2023-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k230838-cardinal-health-smartgown-edge-fda-510k.jpg K230838 - Cardinal Health™ SmartGown™ EDGE Breathable Surgical Gown with ASSIST™ Instrument Pockets K230838 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cardinal Health200, LLC. Cleared Jul 2023. https://www.510kdatabase.net/k231044/ 2023-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k231044-r2p-navicross-fda-510k.jpg K231044 - R2P Navicross K231044 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corporation. Cleared Jul 2023. https://www.510kdatabase.net/k231195/ 2023-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k231195-brainomix-360-triage-ich-fda-510k.jpg K231195 - Brainomix 360 Triage ICH K231195 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainomix Limited. Cleared Jul 2023. https://www.510kdatabase.net/k231221/ 2023-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k231221-mdx-chex-for-bc-gp-fda-510k.jpg K231221 - MDx-Chex for BC-GP K231221 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Streck. Cleared Jul 2023. https://www.510kdatabase.net/k231223/ 2023-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k231223-mdx-chex-for-bc-gn-fda-510k.jpg K231223 - MDx-Chex for BC-GN K231223 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Streck. Cleared Jul 2023. https://www.510kdatabase.net/k231236/ 2023-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k231236-ibs-b-mis-beveled-screw-system-fda-510k.jpg K231236 - IBS-B MIS Beveled Screw System K231236 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: In2bones USA, LLC. Cleared Jul 2023. https://www.510kdatabase.net/k231261/ 2023-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k231261-altaviz-needle-kit-ii-fda-510k.jpg K231261 - Altaviz Needle Kit II K231261 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Altaviz, LLC. Cleared Jul 2023. https://www.510kdatabase.net/k231555/ 2023-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k231555-luma-led-patches-luma-blemish-tn2197-fda-510k.jpg K231555 - LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189)) K231555 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: iSMART Developments, Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k231886/ 2023-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k231886-surgivisio-device-fda-510k.jpg K231886 - SURGIVISIO Device K231886 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ecential Robotics. Cleared Jul 2023. https://www.510kdatabase.net/k231912/ 2023-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k231912-therm-x-fda-510k.jpg K231912 - Therm-X K231912 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zenith Technical Innovations. Cleared Jul 2023. https://www.510kdatabase.net/k220765/ 2023-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k220765-hs-fiber-cerclage-fda-510k.jpg K220765 - HS Fiber Cerclage K220765 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Riverpoint Medical, LLC. Cleared Jul 2023. https://www.510kdatabase.net/k222874/ 2023-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k222874-carboclear-cervical-cage-system-fda-510k.jpg K222874 - CarboClear Cervical Cage System, CarboClear Cervical VBR System K222874 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Carbofix Orthpedics , Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k222994/ 2023-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k222994-arm-blood-pressure-monitor-models-aoj-fda-510k.jpg K222994 - Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33B K222994 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen AOJ Medical Technology Co., Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k231038/ 2023-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k231038-global-hypoperfusion-index-ghi-algorithm-fda-510k.jpg K231038 - Global Hypoperfusion Index (GHI) Algorithm K231038 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Jul 2023. https://www.510kdatabase.net/k231172/ 2023-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k231172-apolloknee-fda-510k.jpg K231172 - ApolloKnee K231172 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corin U.S.A. Limited. Cleared Jul 2023. https://www.510kdatabase.net/k231572/ 2023-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k231572-umi-panorama-fda-510k.jpg K231572 - uMI Panorama K231572 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k231787/ 2023-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k231787-ecofix-fda-510k.jpg K231787 - ecoFIX® K231787 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Science & Bio Materials (S.B.M.) Sas. Cleared Jul 2023. https://www.510kdatabase.net/k231922/ 2023-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k231922-depuy-synthes-maxframe-autostrut-system-fda-510k.jpg K231922 - DEPUY SYNTHES MAXFRAME AUTOSTRUT System K231922 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Synthes. Cleared Jul 2023. https://www.510kdatabase.net/k213536/ 2023-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k213536-deka-ace-pump-system-fda-510k.jpg K213536 - DEKA ACE Pump System K213536 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Deka Research and Development. Cleared Jul 2023. https://www.510kdatabase.net/k221605/ 2023-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k221605-emit-ii-plus-buprenorphine-assay-fda-510k.jpg K221605 - Emit® II Plus Buprenorphine Assay K221605 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k222438/ 2023-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k222438-a-lyte-integrated-multisensor-imt-na-k-fda-510k.jpg K222438 - A-LYTE® Integrated Multisensor (IMT Na K Cl) K222438 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k223473/ 2023-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k223473-me-apds-fda-510k.jpg K223473 - ME-APDS™ K223473 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Magentiq Eye, Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k230365/ 2023-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k230365-sonio-detect-fda-510k.jpg K230365 - Sonio Detect K230365 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sonio. Cleared Jul 2023. https://www.510kdatabase.net/k230455/ 2023-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k230455-enamel-coating-resin-fda-510k.jpg K230455 - Enamel Coating Resin K230455 is a FDA 510(k) cleared dental medical device. Manufacturer: Rizhao Huge Biomaterials Company, Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k230540/ 2023-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k230540-patient-specific-planning-solution-3d-fda-510k.jpg K230540 - Patient Specific Planning Solution™ 3D Bone Models K230540 is a FDA 510(k) cleared radiology medical device. Manufacturer: Biomet Manufacturing Corp. Cleared Jul 2023. https://www.510kdatabase.net/k230576/ 2023-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k230576-identify-fda-510k.jpg K230576 - IDENTIFY K230576 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k230730/ 2023-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k230730-apyx-fda-510k.jpg K230730 - Apyx K230730 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Escala Medical. Cleared Jul 2023. https://www.510kdatabase.net/k230913/ 2023-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k230913-andi-fda-510k.jpg K230913 - ANDI K230913 is a FDA 510(k) cleared radiology medical device. Manufacturer: Imeka Solutions, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k231275/ 2023-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k231275-exceed-biplanar-expandable-interbody-fda-510k.jpg K231275 - Exceed™ Biplanar Expandable Interbody System K231275 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spine Wave, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k231577/ 2023-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k231577-mobilett-impact-fda-510k.jpg K231577 - MOBILETT Impact K231577 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions. Cleared Jul 2023. https://www.510kdatabase.net/k231621/ 2023-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k231621-reprocessed-viewflex-xtra-ice-catheter-fda-510k.jpg K231621 - Reprocessed ViewFlex Xtra ICE Catheter (D087031) K231621 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Stryker Sustainability Solutions. Cleared Jul 2023. https://www.510kdatabase.net/k231878/ 2023-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k231878-uretero1-single-use-digital-flexible-fda-510k.jpg K231878 - Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101, Uretero1 Single-Use Digital Flexible Ureteroscope (reverse deflection), PN URORD101, Vision1 Imaging Console and Display System, PN VIS101 K231878 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: STERIS Corporation. Cleared Jul 2023. https://www.510kdatabase.net/k231900/ 2023-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k231900-a-tap-previously-called-arthrotap-fda-510k.jpg K231900 - A-TAP (previously called Arthrotap) K231900 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Elcam Medical Acal. Cleared Jul 2023. https://www.510kdatabase.net/k231924/ 2023-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k231924-ez-io-intraosseous-vascular-access-fda-510k.jpg K231924 - EZ-IO Intraosseous Vascular Access System K231924 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Teleflex Medical. Cleared Jul 2023. https://www.510kdatabase.net/k223322/ 2023-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k223322-argus-cognitive-revision-software-fda-510k.jpg K223322 - Argus Cognitive ReVISION Software K223322 is a FDA 510(k) cleared radiology medical device. Manufacturer: Argus Cognitive, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k223347/ 2023-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k223347-ultrasight-ai-guidance-fda-510k.jpg K223347 - UltraSight AI Guidance K223347 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ultrasight, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k223752/ 2023-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k223752-black-non-sterile-powder-free-nitrile-fda-510k.jpg K223752 - Black Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Chloroquine, Cyclosporin A, Retrovir, Gastric Acid and Fentanyl K223752 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Central Medicare Sdn Bhd. Cleared Jul 2023. https://www.510kdatabase.net/k230333/ 2023-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k230333-profisil-fluoride-varnish-combi-pack-fda-510k.jpg K230333 - Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800) K230333 is a FDA 510(k) cleared dental medical device. Manufacturer: Kettenbach GmbH & Co. KG. Cleared Jul 2023. https://www.510kdatabase.net/k231523/ 2023-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k231523-escom250-fda-510k.jpg K231523 - EsCom250 K231523 is a FDA 510(k) cleared dental medical device. Manufacturer: Spident Co., Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k230931/ 2023-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k230931-atlan-fda-510k.jpg K230931 - Atlan K230931 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Dr?gerwerk AG & Co KGaA. Cleared Jul 2023. https://www.510kdatabase.net/k211218/ 2023-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k211218-bd-alaris-system-with-guardrails-suite-fda-510k.jpg K211218 - BD Alaris System with Guardrails Suite MX v12.1.2 K211218 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Carefusion 303, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k221319/ 2023-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k221319-bd-alaris-pump-epidural-infusion-set-fda-510k.jpg K221319 - BD Alaris™ Pump Epidural Infusion Set K221319 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Care Fusion. Cleared Jul 2023. https://www.510kdatabase.net/k221327/ 2023-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k221327-bd-alaris-pump-infusion-sets-fda-510k.jpg K221327 - BD Alaris™ Pump Infusion Sets K221327 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Care Fusion. Cleared Jul 2023. https://www.510kdatabase.net/k223037/ 2023-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k223037-infrared-thermometer-model-ir8807-fda-510k.jpg K223037 - Infrared Thermometer, Model: IR8807 K223037 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shen Zhen Rong Feng Technology Co., Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k223189/ 2023-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k223189-firefighter-nc-pro-ptca-balloon-catheter-fda-510k.jpg K223189 - Firefighter™ NC Pro PTCA Balloon Catheter K223189 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shanghai MicroPort Medical (Group) Co., Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k223288/ 2023-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k223288-cranial-navigation-navigation-software-fda-510k.jpg K223288 - Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI K223288 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Jul 2023. https://www.510kdatabase.net/k223316/ 2023-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k223316-identity-imprint-porous-total-knee-fda-510k.jpg K223316 - Identity Imprint Porous Total Knee Replacement System, Identity Imprint Porous Cruciate Retaining Total Knee Replacement System K223316 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Conformis, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k223317/ 2023-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k223317-alkaline-phosphatase2-fda-510k.jpg K223317 - Alkaline Phosphatase2 K223317 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Ireland Diagnostics Division. Cleared Jul 2023. https://www.510kdatabase.net/k223499/ 2023-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k223499-three-way-stop-cock-fda-510k.jpg K223499 - Three Way Stop Cock K223499 is a FDA 510(k) cleared general hospital medical device. Manufacturer: M/S Romsons International. Cleared Jul 2023. https://www.510kdatabase.net/k223637/ 2023-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k223637-elecsys-probnp-ii-elecsys-probnp-ii-stat-fda-510k.jpg K223637 - Elecsys proBNP II, Elecsys proBNP II STAT K223637 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Jul 2023. https://www.510kdatabase.net/k223769/ 2023-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k223769-nextar-spine-platform-fda-510k.jpg K223769 - NextAR™ Spine Platform K223769 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Jul 2023. https://www.510kdatabase.net/k230150/ 2023-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k230150-optimmri-fda-510k.jpg K230150 - OptimMRI K230150 is a FDA 510(k) cleared radiology medical device. Manufacturer: Rebrain, Sas. Cleared Jul 2023. https://www.510kdatabase.net/k230560/ 2023-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k230560-enspire-300-series-automated-endoscope-fda-510k.jpg K230560 - enspire 300 Series Automated Endoscope Reprocessor System K230560 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Jul 2023. https://www.510kdatabase.net/k231021/ 2023-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k231021-kimtech-polaris-nitrile-powder-free-fda-510k.jpg K231021 - KIMTECH™ Polaris™ Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid K231021 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Kimberly Clark Corporation. Cleared Jul 2023. https://www.510kdatabase.net/k231161/ 2023-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k231161-09-sodium-chloride-injection-usp-bd-fda-510k.jpg K231161 - 0.9% Sodium Chloride Injection, USP BD PosiFlush™ SF Saline Flush Syringe K231161 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson and Company. Cleared Jul 2023. https://www.510kdatabase.net/k231173/ 2023-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k231173-irregular-rhythm-notification-feature-fda-510k.jpg K231173 - Irregular Rhythm Notification Feature (IRNF) K231173 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Apple, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k231474/ 2023-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k231474-erchonia-violet-zerona-z6-otc-fda-510k.jpg K231474 - Erchonia Violet ZERONA® Z6 OTC K231474 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Erchonia Corporation. Cleared Jul 2023. https://www.510kdatabase.net/k231483/ 2023-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k231483-myspine-unilateral-guides-fda-510k.jpg K231483 - MySpine Unilateral Guides K231483 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Jul 2023. https://www.510kdatabase.net/k231516/ 2023-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k231516-inhance-shoulder-system-sterile-single-fda-510k.jpg K231516 - INHANCE™ Shoulder System, Sterile Single Use Instrumentation K231516 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Ireland UC. Cleared Jul 2023. https://www.510kdatabase.net/k231848/ 2023-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k231848-triever20-curve-21-201-fda-510k.jpg K231848 - Triever20 Curve (21-201) K231848 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inari Medical, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k231861/ 2023-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k231861-endofliptm-300-system-fda-510k.jpg K231861 - EndoflipTM 300 System K231861 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Covidien, LLC. Cleared Jul 2023. https://www.510kdatabase.net/k231862/ 2023-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k231862-trudi-navigation-system-v3-fg-2000-00-fda-510k.jpg K231862 - TruDi® Navigation System V3 (FG-2000-00) K231862 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Acclarent, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k213098/ 2023-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k213098-panther-5-fda-510k.jpg K213098 - Panther 5 K213098 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Origin Medical Devices. Cleared Jul 2023. https://www.510kdatabase.net/k220977/ 2023-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k220977-ise-reagents-glucose-crp-latex-dxc-500-fda-510k.jpg K220977 - ISE Reagents, Glucose, CRP Latex, DxC 500 AU Clinical Chemistry Analyzer K220977 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k222920/ 2023-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k222920-oxygen-concentrator-fda-510k.jpg K222920 - Oxygen concentrator K222920 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Zhengzhou Olive Electronic Technology Co., Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k223301/ 2023-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k223301-astra-avant-navigation-instruments-fda-510k.jpg K223301 - ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments System K223301 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinecraft, LLC. Cleared Jul 2023. https://www.510kdatabase.net/k223484/ 2023-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k223484-igar-system-1001a-fda-510k.jpg K223484 - IGAR System (1001.A) K223484 is a FDA 510(k) cleared radiology medical device. Manufacturer: Insight Medbotics, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k223834/ 2023-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k223834-accucheck-fda-510k.jpg K223834 - AccuCheck K223834 is a FDA 510(k) cleared radiology medical device. Manufacturer: Manteia Technologies Co., Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k230039/ 2023-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k230039-uomnispace-fda-510k.jpg K230039 - uOmnispace K230039 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k230377/ 2023-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k230377-crosslead-penetration-peripheral-guide-fda-510k.jpg K230377 - CROSSLEAD Penetration Peripheral Guide Wire K230377 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Asahi Intecc Co., Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k230787/ 2023-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k230787-oscar-15-oscar-15i-fda-510k.jpg K230787 - Oscar 15 & Oscar 15i K230787 is a FDA 510(k) cleared radiology medical device. Manufacturer: Genoray Co., Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k230875/ 2023-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k230875-blue-non-sterile-powder-free-nitrile-fda-510k.jpg K230875 - Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims K230875 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Central Medicare Sdn Bhd. Cleared Jul 2023. https://www.510kdatabase.net/k231103/ 2023-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k231103-rosa-one-brain-application-fda-510k.jpg K231103 - ROSA ONE Brain Application K231103 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtech S.A.S. Cleared Jul 2023. https://www.510kdatabase.net/k231790/ 2023-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k231790-the-inmode-system-with-the-morpheus8-fda-510k.jpg K231790 - The InMode System with the Morpheus8 Applicators K231790 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Inmode , Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k231799/ 2023-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k231799-inertia-connexx-modular-pedicle-screw-fda-510k.jpg K231799 - INERTIA® CONNEXX™ Modular Pedicle Screw System K231799 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nexxt Spine, LLC. Cleared Jul 2023. https://www.510kdatabase.net/k231808/ 2023-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k231808-quasar-standalone-acif-system-fda-510k.jpg K231808 - QUASAR Standalone ACIF System K231808 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: GS Medical Co., Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k231840/ 2023-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k231840-castleloc-s-posterior-cervical-fda-510k.jpg K231840 - CastleLoc-S Posterior Cervical Fixation System K231840 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: L & K Biomed Co., Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k231945/ 2023-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k231945-venacure-evlt-nevertouch-procedure-kits-fda-510k.jpg K231945 - VenaCure EVLT NeverTouch Procedure Kits K231945 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: AngioDynamics, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k210801/ 2023-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k210801-axinon-ldl-p-test-system-fda-510k.jpg K210801 - AXINON® LDL-p Test System K210801 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Numares AG. Cleared Jul 2023. https://www.510kdatabase.net/k223151/ 2023-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k223151-nu-beca-transcutaneous-electrical-fda-510k.jpg K223151 - Nu-beca Transcutaneous Electrical Nerve Stimulation K223151 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nu-Beca & Maxcellent Co.. Cleared Jul 2023. https://www.510kdatabase.net/k230037/ 2023-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k230037-back-3-fda-510k.jpg K230037 - BACK 3 K230037 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Swims America Corp. Cleared Jul 2023. https://www.510kdatabase.net/k231157/ 2023-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k231157-syngoct-lung-cad-version-vd30-fda-510k.jpg K231157 - syngo.CT Lung CAD (Version VD30) K231157 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Healthcare GmbH. Cleared Jul 2023. https://www.510kdatabase.net/k231292/ 2023-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k231292-tamina-35mm-proximal-humerus-system-fda-510k.jpg K231292 - TAMINA 3.5mm Proximal Humerus System K231292 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Bonebridge AG. Cleared Jul 2023. https://www.510kdatabase.net/k231410/ 2023-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k231410-renapure-endotoxin-retentive-filter-fda-510k.jpg K231410 - RenaPure Endotoxin Retentive Filter K231410 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Evoqua Water Technologies, LLC. Cleared Jul 2023. https://www.510kdatabase.net/k231437/ 2023-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k231437-lf900-fda-510k.jpg K231437 - LF900 K231437 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Daesung Maref Co., Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k231448/ 2023-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k231448-tandem-hip-system-fda-510k.jpg K231448 - TANDEM Hip System K231448 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k231472/ 2023-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k231472-mobility-scooter-s1-sport-s1-plus-max-fda-510k.jpg K231472 - Mobility Scooter (S1 SPORT, S1 PLUS, MAX SPORT) K231472 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Suzhou Sweetrich Vehicle Industry Technology Co., Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k231796/ 2023-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k231796-grreen-x-12-model-pht-75chs-fda-510k.jpg K231796 - Grreen X 12 (Model: PHT-75CHS) K231796 is a FDA 510(k) cleared radiology medical device. Manufacturer: VATECH Co., Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k231839/ 2023-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k231839-castleloc-p-anterior-cervical-plate-fda-510k.jpg K231839 - CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate System K231839 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: L & K Biomed Co., Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/den220047/ 2023-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/den220047-galen-es-cooperative-surgical-fda-510k.jpg DEN220047 - Galen ES Cooperative Surgical Assistant Platform, Galen ES DEN220047 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Galen Robotics. Cleared Jul 2023. https://www.510kdatabase.net/k213100/ 2023-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k213100-fmt-reusable-temperature-probes-fda-510k.jpg K213100 - FMT Reusable Temperature Probes K213100 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Metko Medikal VE Ttbbi Cihazlar D1s Ticaret Ltd. Sti. Cleared Jul 2023. https://www.510kdatabase.net/k221107/ 2023-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k221107-trust-fda-510k.jpg K221107 - TRUST K221107 is a FDA 510(k) cleared dental medical device. Manufacturer: Rgorithm Korea. Cleared Jul 2023. https://www.510kdatabase.net/k222925/ 2023-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k222925-hypodermic-syringes-needle-fda-510k.jpg K222925 - Hypodermic Syringes & Needle K222925 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Lifelong Meditech Private Limited. Cleared Jul 2023. https://www.510kdatabase.net/k223339/ 2023-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k223339-bone-chamber-implant-fda-510k.jpg K223339 - Bone Chamber Implant K223339 is a FDA 510(k) cleared dental medical device. Manufacturer: Megagen Implant Co., Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k230716/ 2023-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k230716-robotic-graft-delivery-instruments-fda-510k.jpg K230716 - Robotic Graft Delivery Instruments K230716 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k230945/ 2023-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k230945-forma-medical-headless-compression-screw-fda-510k.jpg K230945 - Forma Medical Headless Compression Screw K230945 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Forma Medical, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k211143/ 2023-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k211143-pulse-oximeter-fda-510k.jpg K211143 - Pulse Oximeter K211143 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Brav Electronic Technologies Co., Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k213953/ 2023-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k213953-bd-vacutainer-trace-element-k2edta-fda-510k.jpg K213953 - BD Vacutainer® Trace Element K2EDTA Tubes, BD Vacutainer® Trace Element Serum Tubes K213953 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Becton, Dickinson and Company. Cleared Jul 2023. https://www.510kdatabase.net/k222683/ 2023-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k222683-fibroid-mapping-reviewer-application-fda-510k.jpg K222683 - Fibroid Mapping Reviewer Application (FMRA) K222683 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nesa Medtech Private Limited. Cleared Jul 2023. https://www.510kdatabase.net/k223252/ 2023-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k223252-truliant-e-px-tibial-inserts-fda-510k.jpg K223252 - TRULIANT® E-PX Tibial Inserts K223252 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k230077/ 2023-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k230077-laserme-fda-510k.jpg K230077 - LaserME K230077 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Neauvia North America. Cleared Jul 2023. https://www.510kdatabase.net/k230087/ 2023-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k230087-point-kinguide-agile-hybrid-navigation-fda-510k.jpg K230087 - “POINT” Kinguide Agile Hybrid Navigation System K230087 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Point Robotics MedTech, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k230257/ 2023-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k230257-arthrex-intramedullary-nails-fda-510k.jpg K230257 - Arthrex Intramedullary Nails K230257 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k230395/ 2023-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k230395-durio-surgical-face-mask-models-501-3-fda-510k.jpg K230395 - Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue) K230395 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Durio Ppe Sdn Bhd. Cleared Jul 2023. https://www.510kdatabase.net/k230407/ 2023-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k230407-flonavi-open-field-fluorescence-fda-510k.jpg K230407 - FloNavi Open Field Fluorescence Imaging System K230407 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Guangdong Optomedic Technologies, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k230462/ 2023-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k230462-optix-h2-patient-specific-instrument-fda-510k.jpg K230462 - OPTIX H2 Patient Specific Instrument System K230462 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Vilex, LLC. Cleared Jul 2023. https://www.510kdatabase.net/k230558/ 2023-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k230558-revital-ox-paa-high-level-disinfectant-fda-510k.jpg K230558 - Revital-Ox PAA High Level Disinfectant Chemical Indicator K230558 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Jul 2023. https://www.510kdatabase.net/k230846/ 2023-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k230846-itotal-identity-knee-replacement-system-fda-510k.jpg K230846 - iTotal Identity Knee Replacement System K230846 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Conformis, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k231441/ 2023-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k231441-arix-ankle-system-fda-510k.jpg K231441 - ARIX Ankle System K231441 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Jeil Medical Corporation. Cleared Jul 2023. https://www.510kdatabase.net/k231456/ 2023-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k231456-avitus-dragonwing-large-volume-fda-510k.jpg K231456 - Avitus® DragonWing Large Volume Autograft Delivery System K231456 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Avitus Orthopaedics, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k231460/ 2023-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k231460-fortis-and-hana-anterior-cervical-fda-510k.jpg K231460 - FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System, and Osprey™ Anterior Cervical Plate System K231460 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: K&J Consulting Corp.. Cleared Jul 2023. https://www.510kdatabase.net/k220282/ 2023-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k220282-i-stat-ptplus-cartridge-with-the-i-fda-510k.jpg K220282 - i-STAT PTplus Cartridge with the i-STAT 1 System K220282 is a FDA 510(k) cleared hematology medical device. Manufacturer: Abbott Laboratories. Cleared Jul 2023. https://www.510kdatabase.net/k221673/ 2023-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k221673-bonafix-tibase-fda-510k.jpg K221673 - Bonafix TiBase K221673 is a FDA 510(k) cleared dental medical device. Manufacturer: Zentek Medical, LLC. Cleared Jul 2023. https://www.510kdatabase.net/k222026/ 2023-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k222026-neodent-implant-system-zirconia-fda-510k.jpg K222026 - Neodent Implant System - Zirconia Implant System K222026 is a FDA 510(k) cleared dental medical device. Manufacturer: Jjgc Industria E Comercio DE Materiais Dentarios S.A.. Cleared Jul 2023. https://www.510kdatabase.net/k223106/ 2023-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k223106-brainlab-elements-image-fusion-fda-510k.jpg K223106 - Brainlab Elements Image Fusion, Contouring (4.5) K223106 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab AG. Cleared Jul 2023. https://www.510kdatabase.net/k223173/ 2023-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k223173-proxeo-ultra-pb-510-pb-520-and-pb-530-fda-510k.jpg K223173 - Proxeo ULTRA (PB-510, PB-520 and PB-530) K223173 is a FDA 510(k) cleared dental medical device. Manufacturer: W&H Dentalwerk Buermoss GmbH. Cleared Jul 2023. https://www.510kdatabase.net/k223290/ 2023-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k223290-commandep-data-manager-pc-dpc02-fda-510k.jpg K223290 - CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02) K223290 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sentiar, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k223791/ 2023-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k223791-talwire-fda-510k.jpg K223791 - TalWire K223791 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Embrace Medical , Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k223886/ 2023-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k223886-wearable-breast-pump-model-s18-fda-510k.jpg K223886 - Wearable Breast Pump (Model S18) K223886 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shenzhen TPH Technology Co., Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k230016/ 2023-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k230016-cercare-medical-neurosuite-fda-510k.jpg K230016 - Cercare Medical Neurosuite K230016 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cercare Medical A/S. Cleared Jul 2023. https://www.510kdatabase.net/k230269/ 2023-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k230269-ultraflex-tracheobronchial-stent-system-fda-510k.jpg K230269 - Ultraflex™ Tracheobronchial Stent System K230269 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Boston Scientific Corporation. Cleared Jul 2023. https://www.510kdatabase.net/k230445/ 2023-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k230445-onx-tough-fda-510k.jpg K230445 - OnX Tough K230445 is a FDA 510(k) cleared dental medical device. Manufacturer: Sprintray, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k231041/ 2023-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k231041-jivex-model-number-release-54-fda-510k.jpg K231041 - JiveX (Model Number / Release: 5.4) K231041 is a FDA 510(k) cleared radiology medical device. Manufacturer: Visus Health IT GmbH. Cleared Jul 2023. https://www.510kdatabase.net/k231392/ 2023-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k231392-navinetics-reusable-stereotactic-fda-510k.jpg K231392 - NaviNetics Reusable Stereotactic System (NN1000) K231392 is a FDA 510(k) cleared neurology medical device. Manufacturer: Navinetics, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k231428/ 2023-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k231428-mobility-scooter-models-w3431d-fda-510k.jpg K231428 - Mobility Scooter (Models: W3431D) K231428 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zhejiang Innuovo Rehabilitation Devices Co.,Ltd. Cleared Jul 2023. https://www.510kdatabase.net/k231757/ 2023-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k231757-ez3d-i-e3-fda-510k.jpg K231757 - Ez3D-i /E3 K231757 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ewoosoft Co., Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k231782/ 2023-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k231782-flowsaver-blood-return-system-80-101-fda-510k.jpg K231782 - FlowSaver Blood Return System (80-101) K231782 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inari Medical, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k231841/ 2023-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k231841-pathloc-si-joint-fusion-system-fda-510k.jpg K231841 - PathLoc SI Joint Fusion System K231841 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: L & K Biomed Co., Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/den230012/ 2023-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/den230012-ruthless-spine-rjb-fda-510k.jpg DEN230012 - Ruthless Spine RJB DEN230012 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ruthless, LLC Dba Ruthless Spine. Cleared Jul 2023. https://www.510kdatabase.net/k221961/ 2023-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k221961-hydromark-plus-breast-biopsy-site-marker-fda-510k.jpg K221961 - HydroMARK Plus Breast Biopsy Site Marker K221961 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Devicor Medical Products, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k222116/ 2023-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k222116-atellica-ci-analyzer-atellica-fda-510k.jpg K222116 - Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP) K222116 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k223125/ 2023-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k223125-xr90-xr90-sys-fda-510k.jpg K223125 - XR90 (XR90-SYS) K223125 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mediview Xr, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k223261/ 2023-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k223261-open-rib-fda-510k.jpg K223261 - Open Rib K223261 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Informatics, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k223424/ 2023-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k223424-spine-auto-views-fda-510k.jpg K223424 - Spine Auto Views K223424 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems SCS. Cleared Jul 2023. https://www.510kdatabase.net/k223426/ 2023-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k223426-echelon-synergy-mri-system-fda-510k.jpg K223426 - ECHELON Synergy MRI system K223426 is a FDA 510(k) cleared radiology medical device. Manufacturer: Fujifilm Healthcare Corporation. Cleared Jul 2023. https://www.510kdatabase.net/k223728/ 2023-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k223728-micro-rx-fda-510k.jpg K223728 - Micro Rx K223728 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Imds Operations B.V.. Cleared Jul 2023. https://www.510kdatabase.net/k230611/ 2023-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k230611-x80-radiant-photoelectric-therapy-fda-510k.jpg K230611 - X80 / RADiant / PhotoElectric Therapy System (RADiant Aura) K230611 is a FDA 510(k) cleared radiology medical device. Manufacturer: Xstrahl, Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k230863/ 2023-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k230863-zeus-solinas-borrelia-vlse1pepc10-fda-510k.jpg K230863 - ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System K230863 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Zeus Scientific. Cleared Jul 2023. https://www.510kdatabase.net/k230877/ 2023-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k230877-admira-fusion-5-fda-510k.jpg K230877 - Admira Fusion 5 K230877 is a FDA 510(k) cleared dental medical device. Manufacturer: Voco GmbH. Cleared Jul 2023. https://www.510kdatabase.net/k231064/ 2023-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k231064-reddyport-elbow-fda-510k.jpg K231064 - ReddyPort Elbow K231064 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Smd Manufacturing, LLC. Cleared Jul 2023. https://www.510kdatabase.net/k231351/ 2023-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k231351-chondral-quant-fda-510k.jpg K231351 - Chondral Quant K231351 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Soultions USA, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k231438/ 2023-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k231438-calibrate-psx-interbody-system-fda-510k.jpg K231438 - Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System K231438 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k231449/ 2023-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k231449-portable-x-ray-system-model-ray98p-fda-510k.jpg K231449 - Portable X-ray System Model Ray98(P) K231449 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ningbo Runyes Medical Instrument Co., Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k231754/ 2023-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k231754-praxiject-09-nacl-fda-510k.jpg K231754 - Praxiject™ 0.9% NaCl K231754 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medxl, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k231769/ 2023-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k231769-activl-next-generation-instrumentation-fda-510k.jpg K231769 - activL® Next Generation Instrumentation K231769 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aesculap Implants Systems, LLC. Cleared Jul 2023. https://www.510kdatabase.net/k231833/ 2023-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k231833-biograph-visionx-and-biograph-visionx-fda-510k.jpg K231833 - Biograph Vision.X and Biograph Vision.X Edge K231833 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k223631/ 2023-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k223631-comprehensive-segmental-revision-fda-510k.jpg K223631 - Comprehensive Segmental Revision System(SRS) K223631 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet Orthopedics. Cleared Jul 2023. https://www.510kdatabase.net/k223808/ 2023-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k223808-zavation-navigation-instrument-system-fda-510k.jpg K223808 - Zavation Navigation Instrument System K223808 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zavation Medical Products, LLC. Cleared Jul 2023. https://www.510kdatabase.net/k230532/ 2023-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k230532-radx-intraoral-appliance-for-snoring-fda-510k.jpg K230532 - RADx Intraoral Appliance for Snoring and Sleep Apnea K230532 is a FDA 510(k) cleared dental medical device. Manufacturer: Achaemenid, LLC. Cleared Jul 2023. https://www.510kdatabase.net/k230823/ 2023-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k230823-ausculthing-acc-fda-510k.jpg K230823 - AusculThing ACC K230823 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ausculthing OY. Cleared Jul 2023. https://www.510kdatabase.net/k231035/ 2023-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k231035-fusedco-algorithm-fda-510k.jpg K231035 - FusedCO Algorithm K231035 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Jul 2023. https://www.510kdatabase.net/k231241/ 2023-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k231241-nanohive-medical-lumbar-interbody-system-fda-510k.jpg K231241 - NanoHive Medical Lumbar Interbody System K231241 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: NanoHive Medical, LLC. Cleared Jul 2023. https://www.510kdatabase.net/k231709/ 2023-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k231709-acuitydr-1013-g4-acuitydr-1417-g4-fda-510k.jpg K231709 - AcuityDR 1013 G4, AcuityDR 1417 G4, AcuityDR 1717G4 K231709 is a FDA 510(k) cleared radiology medical device. Manufacturer: Radmedix, LLC. Cleared Jul 2023. https://www.510kdatabase.net/k231714/ 2023-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k231714-graftys-quickset-fda-510k.jpg K231714 - Graftys Quickset K231714 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Graftys. Cleared Jul 2023. https://www.510kdatabase.net/k221137/ 2023-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k221137-play-and-joy-water-based-lubricant-fda-510k.jpg K221137 - Play and Joy Water-Based Lubricant K221137 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Innovemed Bio-Tech Co., Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k230307/ 2023-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k230307-dentis-i-clean-system-fda-510k.jpg K230307 - Dentis i-Clean System K230307 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentis Co., Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k230427/ 2023-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k230427-cusa-clarity-ultrasonic-surgical-fda-510k.jpg K230427 - CUSA Clarity Ultrasonic Surgical Aspirator System K230427 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Integra LifeSciences Corporation. Cleared Jul 2023. https://www.510kdatabase.net/k230680/ 2023-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k230680-anthogyr-surgical-cassettes-fda-510k.jpg K230680 - Anthogyr Surgical Cassettes K230680 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Anthogyr. Cleared Jul 2023. https://www.510kdatabase.net/k230942/ 2023-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k230942-spira-posterior-lumbar-spacers-fda-510k.jpg K230942 - SPIRA® Posterior Lumbar Spacers K230942 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Camber Spine Technologies. Cleared Jul 2023. https://www.510kdatabase.net/k231386/ 2023-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k231386-montage-flowable-xro-settable-fda-510k.jpg K231386 - Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste K231386 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthocon, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k231528/ 2023-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k231528-bonalive-orthopedics-granules-fda-510k.jpg K231528 - Bonalive Orthopedics granules K231528 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Bonalive Biomaterials, Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k231711/ 2023-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k231711-microinr-system-fda-510k.jpg K231711 - microINR System K231711 is a FDA 510(k) cleared hematology medical device. Manufacturer: Iline Microsystems, S.L.. Cleared Jul 2023. https://www.510kdatabase.net/k231735/ 2023-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k231735-nuvasive-coroent-small-interbody-system-fda-510k.jpg K231735 - NuVasive CoRoent Small Interbody System K231735 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Jul 2023. https://www.510kdatabase.net/k231925/ 2023-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k231925-minima-s-system-fda-510k.jpg K231925 - MINIMA S System K231925 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Lima Corporate S.P.A.. Cleared Jul 2023. https://www.510kdatabase.net/k220646/ 2023-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k220646-playjoy-invisilube-lubricant-capsule-fda-510k.jpg K220646 - Play&Joy InvisiLube Lubricant Capsule K220646 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Innovemed Bio-Tech Co., Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k221307/ 2023-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k221307-edge-upper-cervical-system-fda-510k.jpg K221307 - Edge Upper Cervical System K221307 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinal Simplicity, LLC. Cleared Jul 2023. https://www.510kdatabase.net/k222666/ 2023-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k222666-x-view-3d-panx-view-2d-pan-fda-510k.jpg K222666 - X-View 3D Pan/X-View 2D Pan K222666 is a FDA 510(k) cleared radiology medical device. Manufacturer: Trident S.R.L. Cleared Jul 2023. https://www.510kdatabase.net/k223213/ 2023-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k223213-tandem-mobi-insulin-pump-with-fda-510k.jpg K223213 - Tandem Mobi Insulin Pump with Interoperable Technology K223213 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Tandem Diabetes Care, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k223683/ 2023-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k223683-enteraloc-flow-fda-510k.jpg K223683 - EnteraLoc Flow K223683 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Vonco Products. Cleared Jul 2023. https://www.510kdatabase.net/k223724/ 2023-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k223724-mozi-tps-fda-510k.jpg K223724 - MOZI TPS K223724 is a FDA 510(k) cleared radiology medical device. Manufacturer: Manteia Technologies Co., Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k231091/ 2023-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k231091-acqmap-high-resolution-imaging-and-fda-510k.jpg K231091 - AcQMap High Resolution Imaging and Mapping System K231091 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Acutus Medical, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k231312/ 2023-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k231312-pentaray-nav-eco-high-density-mapping-fda-510k.jpg K231312 - PENTARAY® NAV ECO High Density Mapping Catheter, DECANAV® Mapping Catheter, Webster® CS Catheter with Auto ID, Webster® CS Catheter with EZ Steer Technology, Webster® CS Catheter with EZ Steer Technology with Auto ID K231312 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biosense Webster, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k231387/ 2023-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k231387-endofill-fda-510k.jpg K231387 - Endofill K231387 is a FDA 510(k) cleared dental medical device. Manufacturer: Lumendo AG. Cleared Jul 2023. https://www.510kdatabase.net/k231412/ 2023-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k231412-carto-vizigo-85f-bi-directional-fda-510k.jpg K231412 - CARTO VIZIGO® 8.5F Bi-Directional Guiding Sheath (D-1385-01-S, D-1385-02-S, D-1385-03-S) K231412 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biosense Webster, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k231701/ 2023-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k231701-ziehm-vision-rfd-3d-fda-510k.jpg K231701 - Ziehm Vision RFD 3D K231701 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ziehm Imaging GmbH. Cleared Jul 2023. https://www.510kdatabase.net/k222707/ 2023-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k222707-ih-implant-system-fda-510k.jpg K222707 - IH Implant System K222707 is a FDA 510(k) cleared dental medical device. Manufacturer: Sewonmedix, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k223382/ 2023-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k223382-aevicemd-fda-510k.jpg K223382 - AeviceMD K223382 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Aevice Health Pte. , Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k223388/ 2023-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k223388-invia-integrated-dressing-fda-510k.jpg K223388 - Invia® Integrated Dressing K223388 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medela AG. Cleared Jul 2023. https://www.510kdatabase.net/k223448/ 2023-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k223448-bladder-scanner-model-bvt02-fda-510k.jpg K223448 - Bladder Scanner Model: BVT02 K223448 is a FDA 510(k) cleared radiology medical device. Manufacturer: Xuzhou Kaixin Electronic Instrument Co., Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k223578/ 2023-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k223578-t3-platform-software-fda-510k.jpg K223578 - T3 Platform software K223578 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Etiometry, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k230080/ 2023-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k230080-blood-collection-set-blood-collection-fda-510k.jpg K230080 - Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood K230080 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Yangzhou Medline Industry, Co., Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k230804/ 2023-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k230804-complement-kit-cases-fda-510k.jpg K230804 - Complement Kit Cases K230804 is a FDA 510(k) cleared general hospital medical device. Manufacturer: JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A.. Cleared Jul 2023. https://www.510kdatabase.net/k230932/ 2023-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k230932-andorate-valve-kit-fda-510k.jpg K230932 - ANDORATE® Valve Kit K230932 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ga Health Company Limited. Cleared Jul 2023. https://www.510kdatabase.net/k231253/ 2023-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k231253-overture-orthopaedics-patellofemoral-fda-510k.jpg K231253 - Overture Orthopaedics Patellofemoral System K231253 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Overture Resurfacing, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k231318/ 2023-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k231318-electromagnetic-stimulator-devicemodel-fda-510k.jpg K231318 - Electromagnetic Stimulator Device(Model EM Contouring and Tesla Duet) K231318 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Beijing Adss Development Co., Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k231668/ 2023-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k231668-spine-camp-11-fda-510k.jpg K231668 - Spine CAMP™ (1.1) K231668 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medical Metrics, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k231844/ 2023-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k231844-promis-fixation-system-fda-510k.jpg K231844 - ProMIS™ Fixation System K231844 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Premia Spine, Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k232011/ 2023-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k232011-cleo-fda-510k.jpg K232011 - Cleo K232011 is a FDA 510(k) cleared dental medical device. Manufacturer: American Orthodontics. Cleared Jul 2023. https://www.510kdatabase.net/den220058/ 2023-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/den220058-bt-001-fda-510k.jpg DEN220058 - BT-001 DEN220058 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Better Therapeutics. Cleared Jul 2023. https://www.510kdatabase.net/k221056/ 2023-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k221056-argus-pb-3000-fda-510k.jpg K221056 - ARGUS PB-3000 K221056 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Schiller AG. Cleared Jul 2023. https://www.510kdatabase.net/k222220/ 2023-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k222220-spinmedix-absorbable-fibrous-membrane-fda-510k.jpg K222220 - SpinMedix Absorbable Fibrous Membrane K222220 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Celestray Biotech Company, LLC.,. Cleared Jul 2023. https://www.510kdatabase.net/k223747/ 2023-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k223747-whitsundays-mask-system-fda-510k.jpg K223747 - Whitsundays Mask System K223747 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Resmed Pty Ltd (Registration Number: 3004604967). Cleared Jul 2023. https://www.510kdatabase.net/k223780/ 2023-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k223780-lumos-3dx-fda-510k.jpg K223780 - Lumos 3DX K223780 is a FDA 510(k) cleared radiology medical device. Manufacturer: 3Dio. Cleared Jul 2023. https://www.510kdatabase.net/k223806/ 2023-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k223806-verticale-triangular-fixation-system-fda-510k.jpg K223806 - VERTICALE® Triangular Fixation System K223806 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Silony Medical GmbH. Cleared Jul 2023. https://www.510kdatabase.net/k230173/ 2023-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k230173-servo-air-lite-ventilator-system-fda-510k.jpg K230173 - Servo-air Lite Ventilator System K230173 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Maquet Critical Care AB. Cleared Jul 2023. https://www.510kdatabase.net/k230510/ 2023-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k230510-myellevate-fda-510k.jpg K230510 - MyEllevate K230510 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cynosure, LLC. Cleared Jul 2023. https://www.510kdatabase.net/k230968/ 2023-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k230968-vybe-rf-electrosurgical-system-fda-510k.jpg K230968 - VYBE RF Electrosurgical System K230968 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: ShenB Co., Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k231003/ 2023-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k231003-laparoscope-21033fa-21033fc-21033wa-fda-510k.jpg K231003 - Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC) K231003 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Guangdong Optomedic Technologies, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k231339/ 2023-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k231339-tyber-medical-pin-and-wire-system-fda-510k.jpg K231339 - Tyber Medical Pin and Wire System (various) K231339 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tyber Medical, LLC. Cleared Jul 2023. https://www.510kdatabase.net/k231568/ 2023-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k231568-hardydisk-ast-sulbactamdurlobactam-fda-510k.jpg K231568 - HardyDisk AST Sulbactam/Durlobactam 10/10µg (SUD20) K231568 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Hardy Diagnostics. Cleared Jul 2023. https://www.510kdatabase.net/k220980/ 2023-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k220980-tissue-approximation-system-tas-fda-510k.jpg K220980 - Tissue Approximation System (TAS) K220980 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Tas Medical, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k221058/ 2023-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k221058-lungtrainer-md2-md3-fda-510k.jpg K221058 - LungTrainer (MD2 & MD3) K221058 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Lung Trainers, LLC. Cleared Jul 2023. https://www.510kdatabase.net/k222015/ 2023-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k222015-integral-titanium-cervical-interbody-fda-510k.jpg K222015 - Integral Titanium Cervical Interbody K222015 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nvision Biomedical Technologies, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k230001/ 2023-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k230001-electric-scooter-model-m2020-fda-510k.jpg K230001 - Electric Scooter (Model: M2020) K230001 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Guangdong Prestige Technology Co., Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k230864/ 2023-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k230864-vitek-2-ast-gram-positive-daptomycin-fda-510k.jpg K230864 - VITEK 2 AST-Gram Positive Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin (<=0.12 - >=8 µg/mL), VITEK 2 AST-GP Daptomycin K230864 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k231279/ 2023-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k231279-peregrine-system-infusion-catheter-4-7-fda-510k.jpg K231279 - Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mm K231279 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ablative Solutions, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k231358/ 2023-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k231358-universal-seal-5-12-mm-fda-510k.jpg K231358 - Universal Seal (5-12 mm) K231358 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k231641/ 2023-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k231641-rotium-bioresorbable-wick-fda-510k.jpg K231641 - Rotium Bioresorbable Wick K231641 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nanofiber Solutions, LLC. Cleared Jul 2023. https://www.510kdatabase.net/k231740/ 2023-07-04 monthly 0.5 https://www.510kdatabase.net/og-image/k231740-memorialtm-gloves-fda-510k.jpg K231740 - MemorialTM Gloves K231740 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Us Glove Supply. Cleared Jul 2023. https://www.510kdatabase.net/k221664/ 2023-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k221664-clearinse-cts-specimen-collection-and-fda-510k.jpg K221664 - CLEARinse CTS Specimen Collection and Transport System K221664 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Aardvark Medical, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k222745/ 2023-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k222745-axial3d-insight-fda-510k.jpg K222745 - Axial3D Insight K222745 is a FDA 510(k) cleared radiology medical device. Manufacturer: Axial Medical Printing Limited. Cleared Jul 2023. https://www.510kdatabase.net/k230025/ 2023-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k230025-ivylaser-handhold-hair-removal-machine-fda-510k.jpg K230025 - IVYLASER Handhold Hair Removal Machine K230025 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ivylaser (Beijing) Technology Co.,Ltd. Cleared Jul 2023. https://www.510kdatabase.net/k230487/ 2023-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k230487-dental-lithium-disilicate-glass-ceramic-fda-510k.jpg K230487 - Dental Lithium Disilicate Glass-Ceramic K230487 is a FDA 510(k) cleared dental medical device. Manufacturer: Fuzhou Rick Brown Biomaterials Co., Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k230569/ 2023-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k230569-cardinal-health-surgical-mask-with-fda-510k.jpg K230569 - Cardinal Health Surgical Mask With Anti-fog Hydrogel (Level 3 ) K230569 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cardinalhealth. Cleared Jul 2023. https://www.510kdatabase.net/k230720/ 2023-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k230720-lustre-3xpress-light-beauty-therapy-fda-510k.jpg K230720 - LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001 K230720 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Light Tree Ventures Europe B.V.. Cleared Jul 2023. https://www.510kdatabase.net/k230901/ 2023-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k230901-premier-hpsa-flex-619096-fda-510k.jpg K230901 - Premier HpSA Flex (619096) K230901 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Meridian Bioscience, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k231280/ 2023-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k231280-carboclear-x-pedicle-screw-system-fda-510k.jpg K231280 - CarboClear® X Pedicle Screw System K231280 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: CarboFix Orthopedics , Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k231653/ 2023-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k231653-bashir-035-endovascular-catheter-fda-510k.jpg K231653 - BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular Catheter K231653 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Thrombolex, Inc.. Cleared Jul 2023. https://www.510kdatabase.net/k230725/ 2023-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k230725-nb-implant-system-fda-510k.jpg K230725 - NB Implant System K230725 is a FDA 510(k) cleared dental medical device. Manufacturer: Arum Dentistry Co., Ltd.. Cleared Jul 2023. https://www.510kdatabase.net/k212409/ 2023-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k212409-ulspira-ts-nitric-oxide-therapy-system-fda-510k.jpg K212409 - Ulspira TS Nitric Oxide Therapy System K212409 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Airgas Therapeutics. Cleared Jun 2023. https://www.510kdatabase.net/k213253/ 2023-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k213253-pixylneuro-fda-510k.jpg K213253 - Pixyl.Neuro K213253 is a FDA 510(k) cleared radiology medical device. Manufacturer: Pixyl SA. Cleared Jun 2023. https://www.510kdatabase.net/k221294/ 2023-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k221294-precardia-occlusion-system-fda-510k.jpg K221294 - preCARDIA Occlusion System K221294 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abiomed, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k222466/ 2023-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k222466-airtom-fda-510k.jpg K222466 - AirTom K222466 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Bilab. Cleared Jun 2023. https://www.510kdatabase.net/k223135/ 2023-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k223135-ablatepal-radiofrequency-ablation-system-fda-510k.jpg K223135 - AblatePal Radiofrequency Ablation System K223135 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Compal Electronics, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k223374/ 2023-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k223374-blood-pressure-monitor-fda-510k.jpg K223374 - Blood Pressure Monitor K223374 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Guangdong Transtek Medical Electronics Co., Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k223694/ 2023-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k223694-tinearity-g1-6103-fda-510k.jpg K223694 - Tinearity G1 (6103) K223694 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Duearity AB. Cleared Jun 2023. https://www.510kdatabase.net/k223854/ 2023-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k223854-unistik-shieldlock-unistik-vacuflip-fda-510k.jpg K223854 - Unistik® ShieldLock, Unistik VacuFlip K223854 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Owen Mumford, Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k230052/ 2023-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k230052-inogen-rove-6-fda-510k.jpg K230052 - Inogen Rove 6 K230052 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Inogen, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k230156/ 2023-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k230156-5f-launcher-guide-catheter-6f-launcher-fda-510k.jpg K230156 - 5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter K230156 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jun 2023. https://www.510kdatabase.net/k230456/ 2023-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k230456-sgm-femoral-nail-system-fda-510k.jpg K230456 - SGM Femoral Nail System K230456 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k230469/ 2023-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k230469-compact-wearable-pump-fda-510k.jpg K230469 - Compact Wearable Pump K230469 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Lansinoh Laboratories. Cleared Jun 2023. https://www.510kdatabase.net/k230917/ 2023-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k230917-febridx-bacterial-non-bacterial-point-fda-510k.jpg K230917 - FebriDx Bacterial / Non-bacterial Point of Care Assay K230917 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Lumos Diagnostics, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k230930/ 2023-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k230930-enspire-3000-cleaning-and-liquid-fda-510k.jpg K230930 - enspire 3000 Cleaning and Liquid Chemical Sterile Processing System K230930 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Jun 2023. https://www.510kdatabase.net/k230933/ 2023-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k230933-remi-remote-eeg-monitoring-system-fda-510k.jpg K230933 - REMI Remote EEG Monitoring System K230933 is a FDA 510(k) cleared neurology medical device. Manufacturer: Epitel, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k230935/ 2023-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k230935-sensititre-20-24-hour-haemophilus-fda-510k.jpg K230935 - Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC, or Breakpoint Susceptibility System with Imipenem-relebactam in the dilution, range of 0.03/4-128-4ug/ml (Haemophilus influenzae) K230935 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Thermo Fisher Scientific. Cleared Jun 2023. https://www.510kdatabase.net/k230944/ 2023-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k230944-memed-bv-fda-510k.jpg K230944 - MeMed BV K230944 is a FDA 510(k) cleared microbiology medical device. Manufacturer: MeMed Diagnostics, Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k230991/ 2023-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k230991-pillcam-sb-3-capsule-endoscopy-system-fda-510k.jpg K230991 - PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E K230991 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Given Imaging Ltd. (Medtronic). Cleared Jun 2023. https://www.510kdatabase.net/k231252/ 2023-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k231252-ventana-l-spinal-system-fda-510k.jpg K231252 - Ventana™ L Spinal System K231252 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinal Elements, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k231264/ 2023-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k231264-easy-on-universal-glaze-stain-fda-510k.jpg K231264 - Easy On Universal Glaze & Stain K231264 is a FDA 510(k) cleared dental medical device. Manufacturer: Doctus Global. Cleared Jun 2023. https://www.510kdatabase.net/k231267/ 2023-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k231267-cleartip-fda-510k.jpg K231267 - ClearTip K231267 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Finemedix Co., Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k231585/ 2023-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k231585-vantage-psi-system-fda-510k.jpg K231585 - Vantage PSI System K231585 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 3D Systems, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k231588/ 2023-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k231588-viewflex-eco-reprocessed-ice-catheter-fda-510k.jpg K231588 - ViewFlex™ Eco Reprocessed ICE Catheter K231588 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared Jun 2023. https://www.510kdatabase.net/k231596/ 2023-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k231596-iob-temperature-management-system-fda-510k.jpg K231596 - IOB Temperature Management System K231596 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Iob Medical, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k231689/ 2023-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k231689-ifuse-torq-implant-system-fda-510k.jpg K231689 - iFuse TORQ® Implant System K231689 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SI-BONE, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k221436/ 2023-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k221436-fp-950-accessory-breathing-circuit-kits-fda-510k.jpg K221436 - F&P 950 Accessory Breathing Circuit Kits K221436 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Fisher &Paykel Healthcare , Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k222933/ 2023-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k222933-myah-fda-510k.jpg K222933 - MYAH K222933 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Visia Imaging S.R.L.. Cleared Jun 2023. https://www.510kdatabase.net/k223047/ 2023-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k223047-neuroswift-pro-fda-510k.jpg K223047 - NeuroSwift Pro K223047 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Neurobit Technologies Co., Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k223596/ 2023-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k223596-sqline-kerrison-fda-510k.jpg K223596 - SQ.line KERRISON K223596 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k230176/ 2023-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k230176-upper-arm-blood-pressure-monitor-fda-510k.jpg K230176 - Upper Arm Blood Pressure Monitor K230176 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Yolanda Technology Co., Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k230337/ 2023-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k230337-earlipoint-fda-510k.jpg K230337 - EarliPoint K230337 is a FDA 510(k) cleared neurology medical device. Manufacturer: Earlitec Diagnostics, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k230374/ 2023-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k230374-coronary-dilatation-balloon-catheter-fda-510k.jpg K230374 - Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Balloon Catheter (VesTraveler®), Coronary Dilatation Balloon Catheter (VexPander®) K230374 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Dongguan TT Medical, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k230595/ 2023-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k230595-osteocentric-acl-fixation-system-fda-510k.jpg K230595 - OsteoCentric ACL Fixation System K230595 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OsteoCentric Technologies. Cleared Jun 2023. https://www.510kdatabase.net/k230866/ 2023-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k230866-hotdog-warming-mattress-return-electrode-fda-510k.jpg K230866 - HotDog Warming Mattress + Return Electrode K230866 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Augustine Temperature Management, LLC. Cleared Jun 2023. https://www.510kdatabase.net/k231101/ 2023-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k231101-flume-catheter-fda-510k.jpg K231101 - Flume Catheter K231101 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Flume Catheter Company, Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k231549/ 2023-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k231549-advantage-ultra-system-advantage-fit-fda-510k.jpg K231549 - Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System K231549 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Jun 2023. https://www.510kdatabase.net/k231553/ 2023-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k231553-overstitch-nxt-endoscopic-suturing-fda-510k.jpg K231553 - OverStitch NXT Endoscopic Suturing System K231553 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Apollo Endosurgery, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k231647/ 2023-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k231647-xenoview-30t-chest-coil-fda-510k.jpg K231647 - XENOVIEW 3.0T Chest Coil K231647 is a FDA 510(k) cleared radiology medical device. Manufacturer: Polarean, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k231691/ 2023-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k231691-phantom-xl-insulated-dilators-fda-510k.jpg K231691 - Phantom XL Insulated Dilators K231691 is a FDA 510(k) cleared neurology medical device. Manufacturer: TeDan Surgical Innovations, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/den200052/ 2023-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/den200052-kidneyintelxdkd-fda-510k.jpg DEN200052 - KidneyIntelX.dkd DEN200052 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Renalytix Ai, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k210924/ 2023-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k210924-e-celsius-medical-system-fda-510k.jpg K210924 - e-Celsius Medical System K210924 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bodycap. Cleared Jun 2023. https://www.510kdatabase.net/k213652/ 2023-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k213652-cresilon-hemostatic-gel-chg-cresilon-fda-510k.jpg K213652 - Cresilon Hemostatic Gel, CHG, Cresilon Hemostatic Gel (CHG) K213652 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cresilon, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k220198/ 2023-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k220198-medi-lift-plus-fda-510k.jpg K220198 - Medi Lift PLUS K220198 is a FDA 510(k) cleared neurology medical device. Manufacturer: Ya-Man, Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k223722/ 2023-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k223722-mio-blood-glucose-monitoring-system-fda-510k.jpg K223722 - MIO Blood Glucose Monitoring System K223722 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Mio Labs, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k230075/ 2023-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k230075-microlife-upper-arm-automatic-digital-fda-510k.jpg K230075 - Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KVl-5K K230075 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Microlife Intellectual Property GmbH. Cleared Jun 2023. https://www.510kdatabase.net/k230859/ 2023-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k230859-aneroid-sphygmomanometer-fda-510k.jpg K230859 - Aneroid Sphygmomanometer K230859 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Wenzhou Kangshun Medical Devices Co.,Ltd. Cleared Jun 2023. https://www.510kdatabase.net/k231232/ 2023-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k231232-curiteva-laminoplasty-system-fda-510k.jpg K231232 - Curiteva Laminoplasty System K231232 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Curiteva, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k213046/ 2023-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k213046-aceconnex-pre-sutured-fascia-fda-510k.jpg K213046 - AceConnex Pre-Sutured Fascia K213046 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Allosource. Cleared Jun 2023. https://www.510kdatabase.net/k222492/ 2023-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k222492-hopeher-vaginal-dilators-fda-510k.jpg K222492 - Hope&Her Vaginal Dilators K222492 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Lujena, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k223100/ 2023-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k223100-hudson-rci-aquatherm-iii-plus-external-fda-510k.jpg K223100 - Hudson RCI AquaTherm III Plus External Adjustable Electronic Heater (050-14) K223100 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Medline Industries, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k230706/ 2023-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k230706-embold-soft-detachable-coil-system-fda-510k.jpg K230706 - EMBOLD™ Soft Detachable Coil System K230706 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Jun 2023. https://www.510kdatabase.net/k230861/ 2023-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k230861-vader-pedicle-system-navigated-fda-510k.jpg K230861 - VADER® Pedicle System Navigated Instruments K230861 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Icotec AG. Cleared Jun 2023. https://www.510kdatabase.net/k230876/ 2023-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k230876-riknee-adjustable-tibia-cut-guide-fda-510k.jpg K230876 - RI.KNEE Adjustable Tibia Cut Guide K230876 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Enztec Limited. Cleared Jun 2023. https://www.510kdatabase.net/k231124/ 2023-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k231124-unistik-3-single-use-safety-lancets-fda-510k.jpg K231124 - Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G) K231124 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Owen Mumford, Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k231219/ 2023-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k231219-nobelzygoma-pureset-tray-fda-510k.jpg K231219 - NobelZygoma PureSet™ Tray K231219 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Nobel Biocare Services AG. Cleared Jun 2023. https://www.510kdatabase.net/k231636/ 2023-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k231636-lnk-spinal-fixation-system-openloc-l-fda-510k.jpg K231636 - LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System. K231636 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: L & K Biomed Co., Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k221488/ 2023-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k221488-z7-zirconia-implant-system-fda-510k.jpg K221488 - Z7 Zirconia Implant System K221488 is a FDA 510(k) cleared dental medical device. Manufacturer: Z7, LLC. Cleared Jun 2023. https://www.510kdatabase.net/k222378/ 2023-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k222378-vitek-2-ast-gram-negative-levofloxacin-fda-510k.jpg K222378 - VITEK 2 AST-Gram Negative Levofloxacin (</=0.125 ->/=8 ug/mL) K222378 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k223138/ 2023-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k223138-ab1-electrosurgical-instrument-creo-fda-510k.jpg K223138 - AB1 Electrosurgical Instrument, Creo Electrosurgical System K223138 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Creo Medical, Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k223143/ 2023-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k223143-sagico-spinal-system-fda-510k.jpg K223143 - SAGICO Spinal System K223143 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Sagico VA USA, LLC. Cleared Jun 2023. https://www.510kdatabase.net/k230492/ 2023-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k230492-avitus-precision-autograft-delivery-fda-510k.jpg K230492 - Avitus® Precision Autograft Delivery System K230492 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Avitus Orthopaedics, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k230867/ 2023-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k230867-bone-bolt-system-fda-510k.jpg K230867 - Bone Bolt System K230867 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: University of Utah, Department of Orthopaedics. Cleared Jun 2023. https://www.510kdatabase.net/k230914/ 2023-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k230914-aris-coblation-turbinate-reduction-fda-510k.jpg K230914 - ARIS¿ COBLATION¿ Turbinate Reduction Wand (72290113) K230914 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: ArthroCare Corporation. Cleared Jun 2023. https://www.510kdatabase.net/k231215/ 2023-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k231215-ipl-hair-removal-device-model-skin-fda-510k.jpg K231215 - IPL Hair Removal Device Model: Skin Expert Pro IPL 008, Skin Expert Pro IPL 008S K231215 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Zhongshan Qizhe Technology Co., Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k222142/ 2023-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k222142-br-sla-type-implant-system-fda-510k.jpg K222142 - BR SLA Type Implant System K222142 is a FDA 510(k) cleared dental medical device. Manufacturer: Biotem Co., Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k220955/ 2023-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k220955-hudson-rci-variable-concentration-fda-510k.jpg K220955 - Hudson RCI Variable concentration Large Volume Nebulizer (1770) K220955 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Medline Industires, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k221411/ 2023-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k221411-surflo-winged-infusion-set-fda-510k.jpg K221411 - Surflo Winged Infusion Set K221411 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terumo Medical Products Hangzhou Co., Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k221827/ 2023-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k221827-mais-central-venous-catheter-fda-510k.jpg K221827 - Mais Central Venous Catheter K221827 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Saudi Mais Co. For Medical Products. Cleared Jun 2023. https://www.510kdatabase.net/k222323/ 2023-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k222323-black-diamond-fda-510k.jpg K222323 - Black Diamond K222323 is a FDA 510(k) cleared dental medical device. Manufacturer: Elevate Oral Care, LLC. Cleared Jun 2023. https://www.510kdatabase.net/k222592/ 2023-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k222592-altivate-anatomic-shoulder-ag-e-with-fda-510k.jpg K222592 - AltiVate® Anatomic Shoulder AG e+™ with Markers K222592 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Encore Medical, L.P.. Cleared Jun 2023. https://www.510kdatabase.net/k222969/ 2023-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k222969-ferti-lily-conception-cup-fda-510k.jpg K222969 - FERTI-LILY Conception Cup K222969 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Rosesta Medical BV. Cleared Jun 2023. https://www.510kdatabase.net/k222982/ 2023-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k222982-virtus-metabolic-monitor-fda-510k.jpg K222982 - Virtus Metabolic Monitor K222982 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Virtus Technology Aps. Cleared Jun 2023. https://www.510kdatabase.net/k223013/ 2023-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k223013-accurecg-analysis-system-fda-510k.jpg K223013 - AccurECG Analysis System K223013 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Accurkardia, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k223019/ 2023-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k223019-sam-20-long-ultrasound-device-fda-510k.jpg K223019 - sam 2.0 Long Ultrasound Device K223019 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: ZetrOZ Systems, LLC. Cleared Jun 2023. https://www.510kdatabase.net/k223048/ 2023-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k223048-medisystem-pacs-fda-510k.jpg K223048 - Medisystem Pacs K223048 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medilab Manutencao E Sitemas Ltda. Cleared Jun 2023. https://www.510kdatabase.net/k223159/ 2023-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k223159-radixact-treatment-delivery-system-fda-510k.jpg K223159 - Radixact Treatment Delivery System K223159 is a FDA 510(k) cleared radiology medical device. Manufacturer: Accuray Incorporated. Cleared Jun 2023. https://www.510kdatabase.net/k223187/ 2023-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k223187-hemosil-liquid-anti-xa-fda-510k.jpg K223187 - HemosIL Liquid Anti-Xa K223187 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jun 2023. https://www.510kdatabase.net/k223638/ 2023-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k223638-neodent-implant-system-helix-short-fda-510k.jpg K223638 - Neodent Implant System - Helix Short Implant System K223638 is a FDA 510(k) cleared dental medical device. Manufacturer: Jjgc Industria E Comercio DE Materiais Dentarios S.A.. Cleared Jun 2023. https://www.510kdatabase.net/k230036/ 2023-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k230036-pre-sutured-tendon-4561sc-single-strand-fda-510k.jpg K230036 - Pre-Sutured Tendon (4561SC / Single Strand) K230036 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Rti Surgical, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k230160/ 2023-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k230160-vinno-g86vinno-g86evinno-g65vinno-fda-510k.jpg K230160 - VINNO G86,VINNO G86E,VINNO G65,VINNO G65P,VINNO G65E,VINNO G65D,VINNO M86, VINNO M86E,VINNO G90,VINNO G90E K230160 is a FDA 510(k) cleared radiology medical device. Manufacturer: Vinno Technology (Suzhou) Co.,Ltd. Cleared Jun 2023. https://www.510kdatabase.net/k230276/ 2023-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k230276-techfit-disrp-system-fda-510k.jpg K230276 - TECHFIT DISRP® System K230276 is a FDA 510(k) cleared dental medical device. Manufacturer: Techfit Digital Surgery. Cleared Jun 2023. https://www.510kdatabase.net/k230359/ 2023-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k230359-koh-ultramicro-injection-cannula-26167nn-fda-510k.jpg K230359 - KOH Ultramicro Injection Cannula (26167NN) K230359 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k230369/ 2023-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k230369-europa-navigated-instruments-fda-510k.jpg K230369 - EUROPA™ Navigated Instruments K230369 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: MiRus, LLC. Cleared Jun 2023. https://www.510kdatabase.net/k230410/ 2023-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k230410-dd-medical-polymers-pmma-fda-510k.jpg K230410 - DD medical polymers (PMMA) K230410 is a FDA 510(k) cleared dental medical device. Manufacturer: Dental Direkt GmbH. Cleared Jun 2023. https://www.510kdatabase.net/k230518/ 2023-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k230518-hydradose-vaginal-suppositories-fda-510k.jpg K230518 - HydraDose Vaginal Suppositories K230518 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: MD Labs, LLC. Cleared Jun 2023. https://www.510kdatabase.net/k230774/ 2023-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k230774-perla-tl-system-fda-510k.jpg K230774 - PERLA® TL System K230774 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spineart. Cleared Jun 2023. https://www.510kdatabase.net/k231117/ 2023-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k231117-nexus-ultrasonic-surgical-aspirator-fda-510k.jpg K231117 - neXus Ultrasonic Surgical Aspirator System K231117 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Misonix, LLC, A Bioventus Company. Cleared Jun 2023. https://www.510kdatabase.net/k231153/ 2023-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k231153-neuhat-hair-growth-system-fda-510k.jpg K231153 - Neuhat Hair Growth System K231153 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Nature, Inc.redible, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k231185/ 2023-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k231185-maprt-fda-510k.jpg K231185 - MapRT K231185 is a FDA 510(k) cleared radiology medical device. Manufacturer: Vision Rt, Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k231505/ 2023-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k231505-gore-acuseal-vascular-graft-fda-510k.jpg K231505 - GORE® ACUSEAL Vascular Graft K231505 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k231532/ 2023-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k231532-actigraph-leap-activity-monitor-fda-510k.jpg K231532 - ActiGraph LEAP activity monitor (ActiGraph LEAP) K231532 is a FDA 510(k) cleared neurology medical device. Manufacturer: Actigraph, LLC. Cleared Jun 2023. https://www.510kdatabase.net/k222932/ 2023-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k222932-invocell-intravaginal-culture-system-fda-510k.jpg K222932 - INVOcell Intravaginal Culture System K222932 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Invo Bioscience. Cleared Jun 2023. https://www.510kdatabase.net/k223083/ 2023-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k223083-straumann-slactive-labeling-changes-fda-510k.jpg K223083 - Straumann SLActive labeling changes K223083 is a FDA 510(k) cleared dental medical device. Manufacturer: Institut Straumann AG. Cleared Jun 2023. https://www.510kdatabase.net/k223379/ 2023-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k223379-portable-oxygen-concentrator-model-p2-fda-510k.jpg K223379 - Portable Oxygen Concentrator (Model: P2-E7, P2-E) K223379 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Qingdao Kingon Medical Science and Technology Co., Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k223558/ 2023-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k223558-cuvis-spine-fda-510k.jpg K223558 - CUVIS-spine K223558 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Curexo, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k223741/ 2023-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k223741-pusen-single-use-flexible-video-fda-510k.jpg K223741 - Pusen Single Use Flexible Video Cystoscope/Choledochoscope System (Single Use Flexible Video Cystoscope/Choledochoscope:PC200-AS, PC200-AR, PC200-S and PC200-R K223741 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Zhuhai Pusen Medical Technology Co., Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k223871/ 2023-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k223871-miria-skin-treatment-system-fda-510k.jpg K223871 - Miria Skin Treatment System K223871 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Avava, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k230322/ 2023-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k230322-selectflex-neurovascular-access-system-fda-510k.jpg K230322 - SelectFlex Neurovascular Access System Family K230322 is a FDA 510(k) cleared neurology medical device. Manufacturer: Q'Apel Medical, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k230444/ 2023-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k230444-talee-talee-postop-fda-510k.jpg K230444 - Talee, Talee PostOp K230444 is a FDA 510(k) cleared neurology medical device. Manufacturer: Invent Medical USA, LLC. Cleared Jun 2023. https://www.510kdatabase.net/k230497/ 2023-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k230497-bladder-ai-aibv01-fda-510k.jpg K230497 - Bladder AI (AIBV01) K230497 is a FDA 510(k) cleared radiology medical device. Manufacturer: Exo, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k230599/ 2023-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k230599-targetcool-fda-510k.jpg K230599 - TargetCool™ K230599 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Recensmedical, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k230904/ 2023-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k230904-arthrex-virtual-implant-positioning-fda-510k.jpg K230904 - Arthrex Virtual Implant Positioning (VIP) System K230904 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k231131/ 2023-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k231131-diode-laser-body-sculpture-systems-fda-510k.jpg K231131 - Diode Laser Body Sculpture Systems K231131 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shanghai Bele Medical Technology Co.,Ltd. Cleared Jun 2023. https://www.510kdatabase.net/k231202/ 2023-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k231202-quickraypro-fda-510k.jpg K231202 - QuickRayPRO K231202 is a FDA 510(k) cleared radiology medical device. Manufacturer: Denterprise International, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k221311/ 2023-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k221311-antibacterial-bandage-fda-510k.jpg K221311 - Antibacterial Bandage K221311 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Winner Medical Co., Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k222658/ 2023-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k222658-accurate-24-non-invasive-blood-fda-510k.jpg K222658 - Accurate 24 Non-invasive blood pressure monitor K222658 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Accurate Meditech, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k223033/ 2023-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k223033-tixel-2-system-fda-510k.jpg K223033 - Tixel® 2 System K223033 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Novoxel , Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k223248/ 2023-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k223248-tablo-hemodialysis-system-fda-510k.jpg K223248 - Tablo® Hemodialysis System K223248 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Outset Medical, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k223376/ 2023-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k223376-monoject-magellan-insulin-safety-fda-510k.jpg K223376 - Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (8881893110) K223376 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cardinal Health200, LLC. Cleared Jun 2023. https://www.510kdatabase.net/k230309/ 2023-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k230309-intra-operative-positioning-system-fda-510k.jpg K230309 - Intra-Operative Positioning System (IOPS®) (MC-1) K230309 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Centerline Biomedical, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k230506/ 2023-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k230506-purelift-pro-edition-fda-510k.jpg K230506 - PureLift Pro Edition K230506 is a FDA 510(k) cleared neurology medical device. Manufacturer: Xtreem Pulse. Cleared Jun 2023. https://www.510kdatabase.net/k230886/ 2023-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k230886-connected-or-hub-with-device-and-voice-fda-510k.jpg K230886 - Connected OR Hub with Device and Voice Control K230886 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker Endoscopy. Cleared Jun 2023. https://www.510kdatabase.net/k231031/ 2023-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k231031-acl-top-family-70-series-fda-510k.jpg K231031 - ACL TOP Family 70 Series K231031 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory Company. Cleared Jun 2023. https://www.510kdatabase.net/k231212/ 2023-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k231212-da-vinci-e-200-electrosurgical-generator-fda-510k.jpg K231212 - da Vinci E-200 Electrosurgical Generator K231212 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical. Cleared Jun 2023. https://www.510kdatabase.net/k231467/ 2023-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k231467-1417wce-1417wce-hr-1417wce-hs-1417wce-gf-fda-510k.jpg K231467 - 1417WCE, 1417WCE-HR, 1417WCE-HS, 1417WCE-GF K231467 is a FDA 510(k) cleared radiology medical device. Manufacturer: Rayence Co., Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k231469/ 2023-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k231469-paxgene-blood-dna-tube-fda-510k.jpg K231469 - PAXgene® Blood DNA Tube K231469 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Preanalytix GmbH. Cleared Jun 2023. https://www.510kdatabase.net/k231485/ 2023-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k231485-ilet-ace-pump-fda-510k.jpg K231485 - iLet® ACE Pump K231485 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beta Bionics, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k231489/ 2023-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k231489-sturdy-autoclave-super-microm-fda-510k.jpg K231489 - Sturdy Autoclave Super Microm K231489 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sturdy Industrial Co., Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k231533/ 2023-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k231533-habib-endohpb-fda-510k.jpg K231533 - Habib EndoHPB K231533 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Jun 2023. https://www.510kdatabase.net/k221024/ 2023-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k221024-tremoflo-c2-airwave-oscillometry-system-fda-510k.jpg K221024 - tremoflo C2 Airwave Oscillometry System K221024 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Thorasys Thoracic Medical Systems, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k222998/ 2023-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k222998-f3-fda-510k.jpg K222998 - F3 K222998 is a FDA 510(k) cleared radiology medical device. Manufacturer: Acrew Imaging, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k223029/ 2023-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k223029-perfit-cl-fda-510k.jpg K223029 - Perfit CL K223029 is a FDA 510(k) cleared dental medical device. Manufacturer: Vatech Mcis Co., Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k223103/ 2023-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k223103-bethaloc-stem-cementless-ha-fda-510k.jpg K223103 - BethaLoc® stem cementless HA K223103 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Implantcast GmbH. Cleared Jun 2023. https://www.510kdatabase.net/k223522/ 2023-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k223522-nc-thermometer-gen-3-model-number-nctg3-fda-510k.jpg K223522 - NC° Thermometer (Gen 3), Model Number: NCTG3 K223522 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Xiamen Intretech, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k223535/ 2023-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k223535-smartbase-abutment-system-fda-510k.jpg K223535 - SMARTbase Abutment System K223535 is a FDA 510(k) cleared dental medical device. Manufacturer: Implant Direct Sybron Manufacturing, LLC. Cleared Jun 2023. https://www.510kdatabase.net/k230346/ 2023-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k230346-voluson-swift-fda-510k.jpg K230346 - Voluson SWIFT K230346 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems Ultrasound & Primary Care Diagnostic, LLC. Cleared Jun 2023. https://www.510kdatabase.net/k230781/ 2023-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k230781-belle-sensilube-fda-510k.jpg K230781 - Belle Sensilube K230781 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Rb Health (Us), LLC. Cleared Jun 2023. https://www.510kdatabase.net/k230796/ 2023-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k230796-sparrow-ascent-fda-510k.jpg K230796 - Sparrow Ascent K230796 is a FDA 510(k) cleared neurology medical device. Manufacturer: Spark Biomedical, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k230993/ 2023-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k230993-coda-anterior-cervical-plate-system-fda-510k.jpg K230993 - CODA™ Anterior Cervical Plate System K230993 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech. Cleared Jun 2023. https://www.510kdatabase.net/k231075/ 2023-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k231075-fluorescence-accessories-yellow-560-fda-510k.jpg K231075 - Fluorescence Accessories (YELLOW 560 and INFRARED 800 with FLOW 800 Option) K231075 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Carl Zeiss Meditec, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k231148/ 2023-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k231148-sclerosafe-150-mm-sclerosafe-350-mm-fda-510k.jpg K231148 - ScleroSafe™ 150 mm, ScleroSafe™ 350 mm K231148 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vvt Medical , Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k231459/ 2023-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k231459-hepafatsmart-v200-fda-510k.jpg K231459 - HepaFatSmart (V2.0.0) K231459 is a FDA 510(k) cleared radiology medical device. Manufacturer: Resonance Health Analysis Services Pty, Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k220072/ 2023-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k220072-sinobot-x1-fda-510k.jpg K220072 - Sinobot X1 K220072 is a FDA 510(k) cleared neurology medical device. Manufacturer: Sinovation (Beijing) Medical Technology Co., Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k223917/ 2023-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k223917-vinno-e20-vinno-e10vinno-e10pvinno-fda-510k.jpg K223917 - VINNO E20, VINNO E10,VINNO E10P,VINNO E10E, VINNO X1,VINNO X1E,VINNO X1P, VINNO X2,VINNO X2E,VINNO X2P K223917 is a FDA 510(k) cleared radiology medical device. Manufacturer: Vinno Technology (Suzhou) Co.,Ltd. Cleared Jun 2023. https://www.510kdatabase.net/k223920/ 2023-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k223920-vinno-g50-vinno-g55-vinno-m50-vinno-fda-510k.jpg K223920 - VINNO G50, VINNO G55, VINNO M50, VINNO E30, VINNO X5, VINNO X6, VINNO X7, VINNO M55, VINNO E35, VINNO X65, VINNO X55, VINNO X35, VINNO G55E, VINNO G55P, VINNO M55E, VINNO M55P, VINNO E35E, VINNO E35P K223920 is a FDA 510(k) cleared radiology medical device. Manufacturer: Vinno Technology (Suzhou) Co.,Ltd. Cleared Jun 2023. https://www.510kdatabase.net/k220107/ 2023-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k220107-mindray-sv600-ventilator-mindray-sv800-fda-510k.jpg K220107 - Mindray SV600 Ventilator, Mindray SV800 Ventilator K220107 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k220703/ 2023-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k220703-fp-950-respiratory-humidifier-fda-510k.jpg K220703 - F&P 950 Respiratory Humidifier K220703 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Fisher & Paykel Healthcare. Cleared Jun 2023. https://www.510kdatabase.net/k220907/ 2023-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k220907-the-inap-one-sleep-therapy-system-fda-510k.jpg K220907 - The iNAP One Sleep Therapy System K220907 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Somnics, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k221121/ 2023-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k221121-volumat-polyethylene-iv-administration-fda-510k.jpg K221121 - Volumat Polyethylene I.V. Administration Set K221121 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Fresenius Kabi. Cleared Jun 2023. https://www.510kdatabase.net/k222597/ 2023-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k222597-babysat-3-fda-510k.jpg K222597 - BabySat 3 K222597 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Owlet Babycare, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k222906/ 2023-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k222906-maxcon-reusable-sharps-container-17-fda-510k.jpg K222906 - Maxcon Reusable Sharps Container, 17 Gallon Sharps Container MA1421 K222906 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ningbo Maxcon Medical Technology Co., Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k222999/ 2023-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k222999-surgical-gown-fda-510k.jpg K222999 - Surgical Gown K222999 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hubei Woozon Healthcare Co., Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k223217/ 2023-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k223217-zynex-monitoring-system-model-cm-1600-fda-510k.jpg K223217 - Zynex Monitoring System, Model CM-1600 K223217 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Zynex Medical, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k223357/ 2023-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k223357-eyeart-v220-fda-510k.jpg K223357 - EyeArt v2.2.0 K223357 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Eyenuk, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k223556/ 2023-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k223556-deepcatch-fda-510k.jpg K223556 - DeepCatch K223556 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medical IP Co., Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k223646/ 2023-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k223646-ib-lab-lama-fda-510k.jpg K223646 - IB Lab LAMA K223646 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ib Lab GmbH. Cleared Jun 2023. https://www.510kdatabase.net/k223890/ 2023-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k223890-naja-gastrointestinal-catheter-fda-510k.jpg K223890 - NAJA Gastrointestinal Catheter K223890 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Chess Medical, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k230015/ 2023-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k230015-omnibone-bone-marrow-biopsy-kit-with-fda-510k.jpg K230015 - OmniBone™ Bone Marrow Biopsy Kit with Power Driver, OmniBone™ Bone Biopsy Kit with Power Driver K230015 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Laurane Medical Sas. Cleared Jun 2023. https://www.510kdatabase.net/k230421/ 2023-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k230421-somatom-edge-plus-somatom-confidence-fda-510k.jpg K230421 - SOMATOM Edge Plus, SOMATOM Confidence, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATOM Drive, SOMATOM Force, SOMATOM Definition Flash K230421 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k230514/ 2023-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k230514-blood-tubing-lines-for-hemodialysis-al-fda-510k.jpg K230514 - Blood Tubing Lines for Hemodialysis AL Series (Archloop), Blood Tubing Lines for Hemodialysis C18 Series K230514 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: NIKKISO CO., LTD.. Cleared Jun 2023. https://www.510kdatabase.net/k230538/ 2023-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k230538-all-day-clear-slim-adcs1-hearing-aid-fda-510k.jpg K230538 - All-Day Clear Slim ADCS1 Hearing Aid. All-Day Clear ADC1 Hearing Aid K230538 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Sonova AG. Cleared Jun 2023. https://www.510kdatabase.net/k230894/ 2023-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k230894-nuvasive-modulus-alif-system-fda-510k.jpg K230894 - NuVasive Modulus ALIF System K230894 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Jun 2023. https://www.510kdatabase.net/k230910/ 2023-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k230910-newvision-sc-tisilfocon-a-scleral-lens-fda-510k.jpg K230910 - NewVision SC (tisilfocon A) Scleral Lens K230910 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Acculens, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k230965/ 2023-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k230965-acuity-100-hexafocon-a-with-tangible-fda-510k.jpg K230965 - Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lens K230965 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Acuity Polymers, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k231045/ 2023-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k231045-healgen-urs-test-strips-fda-510k.jpg K231045 - Healgen URS Test Strips K231045 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Healgen Scientific, LLC. Cleared Jun 2023. https://www.510kdatabase.net/k231110/ 2023-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k231110-manual-wheelchair-a006-fda-510k.jpg K231110 - Manual Wheelchair (A006) K231110 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Ningbo Shenyu Medical Equipment Co.,Ltd. Cleared Jun 2023. https://www.510kdatabase.net/k231136/ 2023-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k231136-fitness-belt-model-klt-07-fda-510k.jpg K231136 - Fitness Belt (Model: KLT-07) K231136 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Shenzhen Kelutongda Industrial Co., Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k231199/ 2023-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k231199-solar-lumbar-interbody-fusion-system-fda-510k.jpg K231199 - Solar Lumbar Interbody Fusion System K231199 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Degen Medical. Cleared Jun 2023. https://www.510kdatabase.net/k231461/ 2023-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k231461-smart-correction-system-ha-half-pins-fda-510k.jpg K231461 - Smart Correction System (HA Half Pins) K231461 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wishbone Medical, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/den220048/ 2023-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/den220048-neoasis-fda-510k.jpg DEN220048 - Neoasis DEN220048 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Invictus Medical, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k222861/ 2023-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k222861-evis-xi-video-system-center-olympus-cv-fda-510k.jpg K222861 - EVIS XI Video System Center Olympus CV-1500, Bronchovideoscope Olympus BF-H1100, Bronchovideoscope Olympus BF-1TH1100 K222861 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Olympus Medical Systems Corporation. Cleared Jun 2023. https://www.510kdatabase.net/k223258/ 2023-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k223258-tni-clear-guard-3-angled-breathing-fda-510k.jpg K223258 - TNI Clear-Guard™ 3 angled breathing filter (1545020) K223258 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Intersurgical , Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k223469/ 2023-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k223469-wallflex-biliary-rx-stent-system-fda-510k.jpg K223469 - WallFlex™ Biliary RX Stent System K223469 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Jun 2023. https://www.510kdatabase.net/k223715/ 2023-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k223715-celerity-incubator-fda-510k.jpg K223715 - Celerity Incubator K223715 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Jun 2023. https://www.510kdatabase.net/k223717/ 2023-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k223717-celerity-5-hp-biological-indicator-fda-510k.jpg K223717 - Celerity 5 HP Biological Indicator K223717 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Jun 2023. https://www.510kdatabase.net/k230386/ 2023-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k230386-spassageq-fda-510k.jpg K230386 - SpassageQ K230386 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Spass, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k230473/ 2023-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k230473-ipl-hair-removal-device-models-mly-t069-fda-510k.jpg K230473 - IPL Hair Removal Device Models: MLY-T069 K230473 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Miley Technology (Hebei) Co., Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k230718/ 2023-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k230718-utc-3ml-medication-cartridge-fda-510k.jpg K230718 - UTC 3mL Medication Cartridge K230718 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Gilero, LLC. Cleared Jun 2023. https://www.510kdatabase.net/k230762/ 2023-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k230762-eden-spinal-fixation-mis-system-fda-510k.jpg K230762 - EDEN Spinal Fixation MIS System K230762 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Jmt Co., Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k231023/ 2023-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k231023-erbejet-2-system-fda-510k.jpg K231023 - ERBEJET® 2 System K231023 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Erbe Elektromedizin GmbH. Cleared Jun 2023. https://www.510kdatabase.net/k231090/ 2023-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k231090-zevo-anterior-cervical-plate-system-fda-510k.jpg K231090 - Zevo Anterior Cervical Plate System K231090 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k231109/ 2023-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k231109-xerxes-hip-stem-fda-510k.jpg K231109 - Xerxes Hip Stem K231109 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Xerxes Arthopedix, LLC. Cleared Jun 2023. https://www.510kdatabase.net/k221540/ 2023-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k221540-synexis-sphere-rx-fda-510k.jpg K221540 - Synexis Sphere Rx K221540 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Synexis, LLC. Cleared Jun 2023. https://www.510kdatabase.net/k222144/ 2023-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k222144-ir-sla-type-implant-system-fda-510k.jpg K222144 - IR SLA Type Implant System K222144 is a FDA 510(k) cleared dental medical device. Manufacturer: Biotem Co., Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k222790/ 2023-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k222790-f65-laser-system-fda-510k.jpg K222790 - F65 Laser System K222790 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lumenis Be, Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k222822/ 2023-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k222822-ventstar-helix-dual-heated-n-plus-fda-510k.jpg K222822 - VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608) K222822 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Draegerwerk AG & CO Kgaa. Cleared Jun 2023. https://www.510kdatabase.net/k223067/ 2023-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k223067-niti-s-duodenal-stent-fda-510k.jpg K223067 - Niti-S Duodenal Stent K223067 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Taewoong Medical Co., Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k223291/ 2023-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k223291-electronic-blood-pressure-monitor-fda-510k.jpg K223291 - Electronic Blood Pressure Monitor K223291 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Pango Medical Electronics Co., Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k230536/ 2023-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k230536-single-use-flexible-rhinolaryngoscope-fda-510k.jpg K230536 - Single-use Flexible Rhinolaryngoscope K230536 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Hunan Vathin Medical Instrument Co., Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k230731/ 2023-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k230731-zavation-alif-system-fda-510k.jpg K230731 - Zavation ALIF System K230731 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zavation Medical Products, LLC. Cleared Jun 2023. https://www.510kdatabase.net/k230761/ 2023-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k230761-trigen-meta-nail-nail-system-fda-510k.jpg K230761 - TRIGEN META-NAIL Nail System K230761 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k231406/ 2023-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k231406-clearumtm-hs-fda-510k.jpg K231406 - ClearumTM HS K231406 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Bellco Srl. Cleared Jun 2023. https://www.510kdatabase.net/k201153/ 2023-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k201153-tisuthes-e-ptfe-surgical-patch-fda-510k.jpg K201153 - Tisuthes e-PTFE Surgical Patch K201153 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shanghai Suokang Medical Implants Co., Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k223517/ 2023-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k223517-clear-aligner-fda-510k.jpg K223517 - Clear Aligner K223517 is a FDA 510(k) cleared dental medical device. Manufacturer: Wuxi EA Medical Instruments Technologies Limited.. Cleared Jun 2023. https://www.510kdatabase.net/k223518/ 2023-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k223518-iortho-fda-510k.jpg K223518 - iOrtho K223518 is a FDA 510(k) cleared dental medical device. Manufacturer: Shanghai EA Medical Instruments Co., Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k230112/ 2023-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k230112-cac-software-fda-510k.jpg K230112 - CAC Software K230112 is a FDA 510(k) cleared radiology medical device. Manufacturer: Imbio, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k230567/ 2023-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k230567-optivu-rosa-mxr-fda-510k.jpg K230567 - OptiVu™ ROSA® MxR K230567 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthosoft Inc. (d/b/a) Zimmer CAS. Cleared Jun 2023. https://www.510kdatabase.net/k230573/ 2023-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k230573-powder-free-latex-patient-examination-fda-510k.jpg K230573 - Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein) K230573 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Kossan International Sdn Bhd. Cleared Jun 2023. https://www.510kdatabase.net/k230759/ 2023-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k230759-safelan-2-modelssafelan-26g-safelan-fda-510k.jpg K230759 - SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro) K230759 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bosungmeditech Co., Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k231145/ 2023-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k231145-axis-anterior-cervical-plate-system-fda-510k.jpg K231145 - Axis Anterior Cervical Plate System K231145 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Southern Medical (Pty) , Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k213754/ 2023-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k213754-spirohome-personal-spirohome-clinic-fda-510k.jpg K213754 - SpiroHome Personal, SpiroHome Clinic K213754 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Inofab Saglik Teknolojileri A.S. Cleared Jun 2023. https://www.510kdatabase.net/k221888/ 2023-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k221888-genadyne-hybrid-foam-dressings-fda-510k.jpg K221888 - Genadyne Hybrid Foam Dressings K221888 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Genadyne Biotechnologies, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k223078/ 2023-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k223078-atellica-ch-diazo-direct-bilirubin-ddbil-fda-510k.jpg K223078 - Atellica® CH Diazo Direct Bilirubin (D_DBil) K223078 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k223669/ 2023-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k223669-secureportiv-advanced-catheter-fda-510k.jpg K223669 - SecurePortIV Advanced Catheter Securement Adhesive K223669 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Adhezion Biomedical, LLC. Cleared Jun 2023. https://www.510kdatabase.net/k230397/ 2023-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k230397-cut-screw-percutaneous-compression-screw-fda-510k.jpg K230397 - Cut Screw - Percutaneous Compression Screw K230397 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: GM Dos Reis Industria e Comercio Ltda.. Cleared Jun 2023. https://www.510kdatabase.net/k231022/ 2023-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k231022-pounce-thrombectomy-system-fda-510k.jpg K231022 - Pounce™ Thrombectomy System K231022 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Surmodics,Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k231466/ 2023-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k231466-rxsight-insertion-device-fda-510k.jpg K231466 - RxSight Insertion Device K231466 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Rxsight, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k223361/ 2023-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k223361-bmr-1900-phisio-fda-510k.jpg K223361 - BMR 1900 PHISIO K223361 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sorin Group Italia S.R.L.. Cleared Jun 2023. https://www.510kdatabase.net/k220498/ 2023-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k220498-novogen-wound-matrix-fda-510k.jpg K220498 - NovoGen Wound Matrix K220498 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Novabone Products, LLC. Cleared Jun 2023. https://www.510kdatabase.net/k222450/ 2023-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k222450-lvis-neuromatch-fda-510k.jpg K222450 - LVIS NeuroMatch K222450 is a FDA 510(k) cleared neurology medical device. Manufacturer: LVIS Corporation. Cleared Jun 2023. https://www.510kdatabase.net/k223091/ 2023-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k223091-ct-perfusion-v10-fda-510k.jpg K223091 - CT Perfusion V1.0 K223091 is a FDA 510(k) cleared radiology medical device. Manufacturer: Olea Medical. Cleared Jun 2023. https://www.510kdatabase.net/k223865/ 2023-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k223865-hemosphere-advanced-monitor-hemosphere-fda-510k.jpg K223865 - HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Assisted Fluid Management software feature with Acumen AFM Cable and Acumen IQ fluid meter, Pressure Controller, Heart Reference Sensor K223865 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Jun 2023. https://www.510kdatabase.net/k230293/ 2023-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k230293-theraface-mask-fda-510k.jpg K230293 - TheraFace Mask K230293 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Therabody, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k230502/ 2023-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k230502-ear-pressure-relief-devicemodeler813b-fda-510k.jpg K230502 - Ear Pressure Relief Device(Model:ER813B) K230502 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Ningbo Albert Novosino Co., Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k230505/ 2023-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k230505-orthopantomograph-op-3d-lx-fda-510k.jpg K230505 - Orthopantomograph™ OP 3D LX K230505 is a FDA 510(k) cleared radiology medical device. Manufacturer: Palodex Group OY. Cleared Jun 2023. https://www.510kdatabase.net/k230512/ 2023-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k230512-gamma4-system-fda-510k.jpg K230512 - Gamma4 System K230512 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker GmbH. Cleared Jun 2023. https://www.510kdatabase.net/k230586/ 2023-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k230586-renuvion-micro-handpiece-fda-510k.jpg K230586 - Renuvion® Micro Handpiece K230586 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Apyx Medical Corporation. Cleared Jun 2023. https://www.510kdatabase.net/k230709/ 2023-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k230709-auryon-atherectomy-system-fda-510k.jpg K230709 - Auryon Atherectomy System K230709 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Eximo Medical, Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k230728/ 2023-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k230728-jusha-c810gc810g-lcd-monitor-jusha-fda-510k.jpg K230728 - JUSHA-C810G/C810G LCD Monitor, JUSHA-C660/JUSHA-C660G/C660/C660G LCD Monitor K230728 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nanjing Jusha Display Technology Co., Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k230744/ 2023-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k230744-acumed-acutrak-3-headless-compression-fda-510k.jpg K230744 - Acumed Acutrak 3 Headless Compression Screw System K230744 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Acumed, LLC. Cleared Jun 2023. https://www.510kdatabase.net/k230768/ 2023-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k230768-m9m9cvm9tm8-elitem10m10cvcrius-fda-510k.jpg K230768 - M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System K230768 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k230776/ 2023-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k230776-momcozy-wearable-electric-breast-pump-fda-510k.jpg K230776 - Momcozy Wearable Electric Breast Pump ( Model: S9 Pro, S12 Pro) K230776 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shenzhen Lutejiacheng Technology Co., Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k230779/ 2023-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k230779-powder-free-nitrile-examination-gloves-fda-510k.jpg K230779 - Powder Free Nitrile Examination Gloves (Black), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate K230779 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shanxi Hongjin Plastic Technology Co., Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k230892/ 2023-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k230892-fixone-biocomposite-anchor-fda-510k.jpg K230892 - Fixone Biocomposite Anchor K230892 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aju Pharm Co., Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k230905/ 2023-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k230905-orthopulse-20e-opi2e-100-fda-510k.jpg K230905 - OrthoPulse 2.0E (OPi2E-100) K230905 is a FDA 510(k) cleared dental medical device. Manufacturer: Biolux Technology GmbH. Cleared Jun 2023. https://www.510kdatabase.net/k230992/ 2023-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k230992-djf-intravascular-administration-set-fda-510k.jpg K230992 - DJF Intravascular Administration Set K230992 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Yangzhou Wei DE LI Trade Co., Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k231037/ 2023-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k231037-myknee-uni-st-fda-510k.jpg K231037 - MyKnee UNI-ST K231037 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Jun 2023. https://www.510kdatabase.net/k231347/ 2023-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k231347-bruxzir-tintefx-coloring-liquid-fda-510k.jpg K231347 - BruxZir™ TintEFX Coloring Liquid K231347 is a FDA 510(k) cleared dental medical device. Manufacturer: Prismatik Dentalcraft, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k231359/ 2023-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k231359-rodin-expandable-lumbar-cage-system-fda-510k.jpg K231359 - RODIN™ Expandable Lumbar Cage System K231359 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ctl Medical Corporation. Cleared Jun 2023. https://www.510kdatabase.net/k231368/ 2023-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k231368-bemer-therapy-system-evo-fda-510k.jpg K231368 - Bemer Therapy System Evo K231368 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Bemer Int AG. Cleared Jun 2023. https://www.510kdatabase.net/den220078/ 2023-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/den220078-eroxon-fda-510k.jpg DEN220078 - Eroxon DEN220078 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Futura Medical Developments Limited. Cleared Jun 2023. https://www.510kdatabase.net/k214124/ 2023-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k214124-allox2-pro-tissue-expanders-fda-510k.jpg K214124 - AlloX2 Pro Tissue Expanders K214124 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sientra, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k222001/ 2023-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k222001-irreversible-electroporation-ablation-fda-510k.jpg K222001 - Irreversible Electroporation Ablation Generator, Irreversible Electroporation Probe K222001 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Zhejiang Curaway Medical Technology Co., Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k222684/ 2023-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k222684-xia-45-spinal-system-xia-45-cortical-fda-510k.jpg K222684 - XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA® Growth Rod Conversion Set, XIA® II Spinal System, XIA® Precision System, XIA® Anterior, Diapason® Spinal System, Opus™ Spinal System, Radius® Spinal System, Mantis® Spinal System, Mantis® Redux, Trio® & Trio+ Spinal Fixation System, ES2™ Spinal System, ES2™ Augmentable Spinal System, Oasys® Occipito-Cervico-Thoracic System, Nile® Proximal Fixation Spinal System, Nile® Alternative Fi K222684 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Spine. Cleared Jun 2023. https://www.510kdatabase.net/k222762/ 2023-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k222762-siddharth-ii-fda-510k.jpg K222762 - SIDDHARTH-II K222762 is a FDA 510(k) cleared radiology medical device. Manufacturer: Panacea Medical Technologies Pvt. , Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k222792/ 2023-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k222792-snucone-tissue-level-implant-system-fda-510k.jpg K222792 - SNUCONE Tissue Level Implant System K222792 is a FDA 510(k) cleared dental medical device. Manufacturer: Snucone Co., Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k223918/ 2023-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k223918-altatrack-equipment-r12-altatrack-fda-510k.jpg K223918 - AltaTrack Equipment R1.2, AltaTrack Guidewire, AltaTrack 3D Hub K223918 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Jun 2023. https://www.510kdatabase.net/k230008/ 2023-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k230008-ablamap-system-fda-510k.jpg K230008 - Ablamap® System K230008 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ablacon, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k230057/ 2023-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k230057-acumen-hypotension-prediction-index-fda-510k.jpg K230057 - Acumen Hypotension Prediction Index (HPI) Algorithm K230057 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Jun 2023. https://www.510kdatabase.net/k230659/ 2023-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k230659-zionic-aesthetic-fda-510k.jpg K230659 - Zionic Aesthetic K230659 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Termosalud. Cleared Jun 2023. https://www.510kdatabase.net/k230715/ 2023-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k230715-promisemed-safety-huber-needle-fda-510k.jpg K230715 - Promisemed Safety Huber Needle K230715 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Promisemed Hangzhou Meditech Co., Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k231042/ 2023-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k231042-disposable-laparoscopic-trocar-fda-510k.jpg K231042 - Disposable Laparoscopic Trocar K231042 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Changzhou Ankang Medical Instruments Co., Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k231350/ 2023-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k231350-ocd-mt-cap-85-00397-000-fda-510k.jpg K231350 - OCD MT Cap (85-00397-000) K231350 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neuronetics. Cleared Jun 2023. https://www.510kdatabase.net/k212183/ 2023-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k212183-sta-r-max-3-sta-compact-max-3-fda-510k.jpg K212183 - STA R Max 3, STA Compact Max 3 K212183 is a FDA 510(k) cleared hematology medical device. Manufacturer: Diagnostica Stago S.A.S. Cleared Jun 2023. https://www.510kdatabase.net/k213611/ 2023-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k213611-fenom-pro-fda-510k.jpg K213611 - Fenom Pro K213611 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Caire Diagnostics, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k222248/ 2023-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k222248-infrared-thermometer-fda-510k.jpg K222248 - Infrared Thermometer K222248 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Alicn Medical (Shenzhen), Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k223059/ 2023-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k223059-xenco-medical-interalign-cervical-fda-510k.jpg K223059 - Xenco Medical InterAlign Cervical Interbody System K223059 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Xenco Medical, LLC. Cleared Jun 2023. https://www.510kdatabase.net/k230381/ 2023-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k230381-ethos-automated-ultrasound-probe-fda-510k.jpg K230381 - Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical Indicator K230381 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cs Medical, LLC. Cleared Jun 2023. https://www.510kdatabase.net/k230446/ 2023-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k230446-tilink-l-si-joint-fusion-system-fda-510k.jpg K230446 - TiLink-L SI Joint Fusion System K230446 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SurGenTec, LLC. Cleared Jun 2023. https://www.510kdatabase.net/k230572/ 2023-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k230572-aetos-shoulder-system-fda-510k.jpg K230572 - AETOS Shoulder System K230572 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k230651/ 2023-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k230651-bd-bbl-sensi-disc-lefamulin-20g-lmu-20-fda-510k.jpg K230651 - BD BBL™ Sensi-Disc™ Lefamulin 20µg (LMU-20) K230651 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson and Company. Cleared Jun 2023. https://www.510kdatabase.net/k230691/ 2023-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k230691-hypervue-imaging-system-fda-510k.jpg K230691 - HyperVue™ Imaging System K230691 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Spectrawave, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k231002/ 2023-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k231002-javelot-pk-s-suture-anchor-javelot-pk-fda-510k.jpg K231002 - Javelot PK-S suture anchor, Javelot PK-S suture anchor (Knotless), Javelot PK-P suture anchor, Javelot PK-P suture anchor (Knotless), Javelot PK-L suture anchor (Knotless) K231002 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Suzhou Endophix Co., Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k231170/ 2023-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k231170-c350c350g-lcd-monitor-fda-510k.jpg K231170 - C350/C350G LCD Monitor K231170 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nanjing Jusha Display Technology Co., Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k231322/ 2023-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k231322-fix2lockpeek-self-punching-fda-510k.jpg K231322 - Fix2Lock(PEEK Self Punching) K231322 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonic Co., Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k231360/ 2023-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k231360-ambra-pacs-fda-510k.jpg K231360 - Ambra PACS K231360 is a FDA 510(k) cleared radiology medical device. Manufacturer: Dicom Grid Dba Ambra Health. Cleared Jun 2023. https://www.510kdatabase.net/k231430/ 2023-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k231430-intimate-rose-vaginal-dilators-fda-510k.jpg K231430 - Intimate Rose Vaginal Dilators K231430 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Plus EV Holdings Dba Intimate Rose. Cleared Jun 2023. https://www.510kdatabase.net/k212733/ 2023-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k212733-diode-laser-therapy-device-fda-510k.jpg K212733 - Diode laser therapy device K212733 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Beijing Star New Tech Co., Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k212734/ 2023-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k212734-diode-laser-therapy-device-fda-510k.jpg K212734 - Diode laser therapy device K212734 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Triangel Rsd Limited. Cleared Jun 2023. https://www.510kdatabase.net/k220117/ 2023-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k220117-arc-intensive-care-information-system-fda-510k.jpg K220117 - ARC Intensive Care Information System (ARC System) K220117 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ordinatrum Solutions. Cleared Jun 2023. https://www.510kdatabase.net/k223532/ 2023-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k223532-olea-sia-neurovascular-v10-fda-510k.jpg K223532 - Olea S.I.A. Neurovascular V1.0 K223532 is a FDA 510(k) cleared radiology medical device. Manufacturer: Olea Medical. Cleared Jun 2023. https://www.510kdatabase.net/k223855/ 2023-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k223855-feops-heartguidetm-feops-heartguidetm-fda-510k.jpg K223855 - FEops HEARTguideTM, FEops HEARTguideTM ALPACA K223855 is a FDA 510(k) cleared radiology medical device. Manufacturer: Feops NV. Cleared Jun 2023. https://www.510kdatabase.net/k230005/ 2023-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k230005-pantheris-lv-atherectomy-catheter-fda-510k.jpg K230005 - Pantheris LV Atherectomy Catheter K230005 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Avinger, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k230261/ 2023-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k230261-gnesis-ems-plus-fda-510k.jpg K230261 - Gnesis EMS Plus K230261 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Creative Fitness Developments S.L.. Cleared Jun 2023. https://www.510kdatabase.net/k230329/ 2023-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k230329-f3d-interbody-system-fda-510k.jpg K230329 - F3D Interbody System K230329 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corelink, LLC. Cleared Jun 2023. https://www.510kdatabase.net/k230584/ 2023-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k230584-vein360-reprocessed-visions-pv035-fda-510k.jpg K230584 - Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter K230584 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vein 360, LLC. Cleared Jun 2023. https://www.510kdatabase.net/k230660/ 2023-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k230660-aviclear-laser-system-fda-510k.jpg K230660 - AviClear Laser System K230660 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cutera, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k231349/ 2023-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k231349-nephron-nitrile-powder-free-nitrile-fda-510k.jpg K231349 - Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs and Fentanyl) K231349 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Nephron Nitrile, LLC. Cleared Jun 2023. https://www.510kdatabase.net/k231635/ 2023-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k231635-a-line-advanced-fda-510k.jpg K231635 - A-Line Advanced K231635 is a FDA 510(k) cleared dental medical device. Manufacturer: Biocetec Co., Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/den220028/ 2023-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/den220028-cue-covid-19-molecular-test-fda-510k.jpg DEN220028 - Cue COVID-19 Molecular Test DEN220028 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Cue Health, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k211618/ 2023-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k211618-fluido-compact-blood-and-fluid-warming-fda-510k.jpg K211618 - Fluido Compact Blood and Fluid Warming System K211618 is a FDA 510(k) cleared general hospital medical device. Manufacturer: The Surgical Company International B.V.. Cleared Jun 2023. https://www.510kdatabase.net/k223718/ 2023-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k223718-handx-self-righting-needle-holder-fda-510k.jpg K223718 - HandX™ Self-Righting Needle Holder K223718 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Human Xtensions , Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k223801/ 2023-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k223801-fx-v135tm-shoulder-prosthesis-fda-510k.jpg K223801 - FX V135(TM) Shoulder Prosthesis K223801 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Fx Shoulder USA, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k230225/ 2023-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k230225-dynaflex-clear-brackets-buttons-fda-510k.jpg K230225 - DynaFlex Clear Brackets & Buttons K230225 is a FDA 510(k) cleared dental medical device. Manufacturer: Dyna Flex. Cleared Jun 2023. https://www.510kdatabase.net/k230498/ 2023-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k230498-artisential-laparoscopic-instruments-fda-510k.jpg K230498 - ArtiSential Laparoscopic Instruments-Electrodes K230498 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Livsmed, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k230633/ 2023-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k230633-apollo-advantage-nitrile-examination-fda-510k.jpg K230633 - APOLLO ADVANTAGE Nitrile Examination Gloves K230633 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Dell Corning Corporation. Cleared Jun 2023. https://www.510kdatabase.net/k230727/ 2023-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k230727-spy-portable-handheld-imaging-spy-phi-fda-510k.jpg K230727 - SPY Portable Handheld Imaging (SPY-PHI) System K230727 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Novadaq Technologies Ulc (A Part of Stryker). Cleared Jun 2023. https://www.510kdatabase.net/k230937/ 2023-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k230937-alinity-i-total-hcg-reagent-kit-glp-fda-510k.jpg K230937 - Alinity i Total ß-hCG Reagent Kit, GLP systems Track K230937 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jun 2023. https://www.510kdatabase.net/k231320/ 2023-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k231320-zhenjiang-assure-mechanical-fda-510k.jpg K231320 - Zhenjiang Assure Mechanical Wheelchair,model:K1 K231320 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zhenjiang Assure Medical Equipment Co., Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k231348/ 2023-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k231348-elecsys-amyloid-1-42-csf-ii-elecsys-fda-510k.jpg K231348 - Elecsys ß-Amyloid (1-42) CSF II, Elecsys Total-Tau CSF K231348 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics. Cleared Jun 2023. https://www.510kdatabase.net/k221752/ 2023-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k221752-stella-fda-510k.jpg K221752 - Stella K221752 is a FDA 510(k) cleared dental medical device. Manufacturer: Shinhung Mst Co., Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k220301/ 2023-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k220301-volumat-line-fda-510k.jpg K220301 - Volumat Line K220301 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Fresenius Kabi. Cleared Jun 2023. https://www.510kdatabase.net/k220728/ 2023-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k220728-vwf-ag-fda-510k.jpg K220728 - vWF Ag K220728 is a FDA 510(k) cleared hematology medical device. Manufacturer: Siemens Healthcare Diagnostics Products GmbH. Cleared Jun 2023. https://www.510kdatabase.net/k221801/ 2023-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k221801-advia-centaur-anti-mllerian-hormone-amh-fda-510k.jpg K221801 - ADVIA Centaur® Anti-Müllerian Hormone (AMH) K221801 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k222018/ 2023-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k222018-breathe-fda-510k.jpg K222018 - Breathe+ K222018 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Peep Medical, LLC Dba Go2 Devices. Cleared Jun 2023. https://www.510kdatabase.net/k222702/ 2023-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k222702-rgs-fda-510k.jpg K222702 - RGS K222702 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Genesis Air, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k222727/ 2023-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k222727-i3-one-203100-s-fda-510k.jpg K222727 - i3 ONE (203100-S) K222727 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: I3 Membrane GmbH. Cleared Jun 2023. https://www.510kdatabase.net/k222961/ 2023-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k222961-harvest-conceal-zr-block-out-fda-510k.jpg K222961 - Harvest Conceal ZR Block Out K222961 is a FDA 510(k) cleared dental medical device. Manufacturer: Harvest Dental Products, LLC. Cleared Jun 2023. https://www.510kdatabase.net/k223074/ 2023-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k223074-corneat-everpatch-fda-510k.jpg K223074 - CorNeat EverPatch K223074 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Corneat Vision , Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k223562/ 2023-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k223562-xpan-universal-trocar-system-fda-510k.jpg K223562 - Xpan Universal Trocar System K223562 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Xpan, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k223822/ 2023-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k223822-activbraid-fda-510k.jpg K223822 - ACTIVBRAID™ K223822 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Embody, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k230214/ 2023-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k230214-huma-rpm-rpm-fda-510k.jpg K230214 - Huma RPM (RPM) K230214 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medopad, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k230635/ 2023-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k230635-pen-needle-fda-510k.jpg K230635 - Pen Needle K230635 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Caina Medical Co.,Ltd. Cleared Jun 2023. https://www.510kdatabase.net/k230888/ 2023-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k230888-titanium-turbine-fda-510k.jpg K230888 - Titanium Turbine K230888 is a FDA 510(k) cleared dental medical device. Manufacturer: Nakanishi, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k230936/ 2023-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k230936-anatomic-peek-cervical-fusion-system-fda-510k.jpg K230936 - Anatomic PEEK™ Cervical Fusion System with Nanotechnology K230936 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nanovis, LLC. Cleared Jun 2023. https://www.510kdatabase.net/k230952/ 2023-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k230952-triathlon-total-knee-system-triathlon-fda-510k.jpg K230952 - Triathlon® Total Knee System - Triathlon® Pro Posterior Stabilized (PS) Femoral Component K230952 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp., Dba Stryker Orthopaedics. Cleared Jun 2023. https://www.510kdatabase.net/k230971/ 2023-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k230971-aptus-35-trilock-straight-plates-fda-510k.jpg K230971 - APTUS® 3.5 TriLock Straight Plates K230971 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medartis AG. Cleared Jun 2023. https://www.510kdatabase.net/k231309/ 2023-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k231309-scar-3-fda-510k.jpg K231309 - SCAR 3 K231309 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: El.En Electroinc Engineering Spa. Cleared Jun 2023. https://www.510kdatabase.net/k231311/ 2023-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k231311-cps-direct-universal-slittable-outer-fda-510k.jpg K231311 - CPS Direct™ Universal slittable outer guide catheter (DS2C029) K231311 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared Jun 2023. https://www.510kdatabase.net/k231314/ 2023-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k231314-fine-osteotomy-fda-510k.jpg K231314 - Fine Osteotomy™ K231314 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Bodycad Laboratories, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/den220041/ 2023-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/den220041-tristel-duo-ult-fda-510k.jpg DEN220041 - Tristel Duo ULT DEN220041 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Tristel Solutions Limited. Cleared Jun 2023. https://www.510kdatabase.net/k222905/ 2023-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k222905-maxcon-sharps-container-1-qt-sharps-fda-510k.jpg K222905 - Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT Sharps Container, MA1212), Maxcon Sharps Container (5.4 QT Sharps Container, MA1213), Maxcon Sharps Container (7 Liter Sharps Container, MA1324) K222905 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ningbo Maxcon Medical Technology Co., Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k223299/ 2023-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k223299-ambu-ascope-5-broncho-hd-5022-ambu-fda-510k.jpg K223299 - Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2 Advance K223299 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Ambu A/S. Cleared Jun 2023. https://www.510kdatabase.net/k223447/ 2023-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k223447-omnitom-elite-fda-510k.jpg K223447 - OmniTom Elite K223447 is a FDA 510(k) cleared radiology medical device. Manufacturer: Neurologica Corporation, A Subsidiary of Samsung. Cleared Jun 2023. https://www.510kdatabase.net/k223498/ 2023-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k223498-radius-vsm-and-accessories-fda-510k.jpg K223498 - Radius VSM and Accessories K223498 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Masimo Corporation. Cleared Jun 2023. https://www.510kdatabase.net/k223555/ 2023-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k223555-brainomix-360-e-ctp-fda-510k.jpg K223555 - Brainomix 360 e-CTP K223555 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainomix Limited. Cleared Jun 2023. https://www.510kdatabase.net/k223676/ 2023-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k223676-somnicheck-fda-510k.jpg K223676 - SomniCheck K223676 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainmatterz, LLC. Cleared Jun 2023. https://www.510kdatabase.net/k223929/ 2023-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k223929-laguna-clot-retriever-system-and-fda-510k.jpg K223929 - Laguna™ Clot Retriever System and Malibu™ Aspiration Catheter System (Laguna Thrombectomy System) K223929 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Innova Vascular, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k230185/ 2023-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k230185-ant-x-system-fda-510k.jpg K230185 - ANT-X System K230185 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ndr Medical Technology Pte. , Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k230408/ 2023-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k230408-k-shield-zen-model-numbers-pbmh-pbma-pbm-fda-510k.jpg K230408 - K-SHIELD Zen (Model Numbers: PBMH/ PBMA/ PBM) K230408 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sb-Kawasumi Laboratories, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k230617/ 2023-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k230617-surgical-face-mask-l-17595mm-fda-510k.jpg K230617 - Surgical Face Mask (L 175*95mm) K230617 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Henan Chaoya Medical Equipment Co., Ltd.. Cleared Jun 2023. https://www.510kdatabase.net/k230827/ 2023-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k230827-hardydisk-ast-rezafungin-5g-rzf5-fda-510k.jpg K230827 - HardyDisk AST Rezafungin 5µg (RZF5) K230827 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Hardy Diagnostics. Cleared Jun 2023. https://www.510kdatabase.net/k230990/ 2023-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k230990-candela-vbeam-family-of-pulsed-dye-fda-510k.jpg K230990 - Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) K230990 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Candela Corporation. Cleared Jun 2023. https://www.510kdatabase.net/k231293/ 2023-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k231293-drakon-and-sequre-microcatheters-fda-510k.jpg K231293 - Drakon™ and Sequre® Microcatheters K231293 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Accurate Medical Therapeutics. Cleared Jun 2023. https://www.510kdatabase.net/k231306/ 2023-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k231306-cobas-sars-cov-2-qualitative-for-use-fda-510k.jpg K231306 - cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems K231306 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Molecular Systems, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k231330/ 2023-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k231330-fibertak-suture-anchor-fda-510k.jpg K231330 - FiberTak® Suture Anchor K231330 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jun 2023. https://www.510kdatabase.net/k211056/ 2023-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k211056-oxus-sieve-beds-fda-510k.jpg K211056 - Oxus Sieve Beds K211056 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Oxus, Inc.. Cleared May 2023. https://www.510kdatabase.net/k213010/ 2023-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k213010-feelject-ldv-low-dead-volume-syringe-fda-510k.jpg K213010 - FEELject LDV (Low dead volume) syringe K213010 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Feeltech Co., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k213992/ 2023-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k213992-combiset-hemodialysis-blood-tubing-set-fda-510k.jpg K213992 - CombiSet Hemodialysis Blood Tubing Set K213992 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC. Cleared May 2023. https://www.510kdatabase.net/k221067/ 2023-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k221067-medline-renewal-reprocessed-st-jude-fda-510k.jpg K221067 - Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter K221067 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Surgical Instrument Service and Savings, Inc.. Cleared May 2023. https://www.510kdatabase.net/k222556/ 2023-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k222556-btl-785x-fda-510k.jpg K222556 - BTL-785X K222556 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: BTL Industries, Inc.. Cleared May 2023. https://www.510kdatabase.net/k222644/ 2023-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k222644-nihon-kohden-nkv-440-ventilator-system-fda-510k.jpg K222644 - Nihon Kohden NKV-440 Ventilator System K222644 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Nihon Kohden Orangemed, Inc.. Cleared May 2023. https://www.510kdatabase.net/k222885/ 2023-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k222885-pegavision-hioxifilcon-a-one-day-soft-fda-510k.jpg K222885 - Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) K222885 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Pegavision Corporation. Cleared May 2023. https://www.510kdatabase.net/k230542/ 2023-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k230542-disposable-nitrile-gloves-abc-dg01-fda-510k.jpg K230542 - Disposable Nitrile Gloves (ABC-DG01) K230542 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Huizhou Anboson Technology Co., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k230671/ 2023-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k230671-pitch-pasoft-tissue-reinforcement-device-fda-510k.jpg K230671 - Pitch PaSoft Tissue Reinforcement Device K230671 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Xiros, Ltd.. Cleared May 2023. https://www.510kdatabase.net/k231259/ 2023-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k231259-iroot-sp-plus-fda-510k.jpg K231259 - iRoot SP Plus K231259 is a FDA 510(k) cleared dental medical device. Manufacturer: Innovative Bioceramix, Inc.. Cleared May 2023. https://www.510kdatabase.net/k231326/ 2023-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k231326-fix2lockbiocomposite-medial-lateral-fda-510k.jpg K231326 - Fix2Lock(Biocomposite medial, lateral, Biocombi Self Punching) K231326 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonic Co., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k220706/ 2023-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k220706-mypao-guides-fda-510k.jpg K220706 - MyPAO Guides K220706 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared May 2023. https://www.510kdatabase.net/k221897/ 2023-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k221897-hydrozid-precise-fda-510k.jpg K221897 - Hydrozid Precise K221897 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bibawo Medical A/S. Cleared May 2023. https://www.510kdatabase.net/k222359/ 2023-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k222359-quicktome-software-suite-fda-510k.jpg K222359 - Quicktome Software Suite K222359 is a FDA 510(k) cleared radiology medical device. Manufacturer: Omniscient Neurotechnology Pty Ltd (O8t). Cleared May 2023. https://www.510kdatabase.net/k223523/ 2023-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k223523-sonic-dl-fda-510k.jpg K223523 - Sonic DL K223523 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems,Llc (Ge Healthcare). Cleared May 2023. https://www.510kdatabase.net/k223762/ 2023-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k223762-smith-nephew-accord-cable-system-fda-510k.jpg K223762 - Smith & Nephew ACCORD™ Cable System K223762 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew. Cleared May 2023. https://www.510kdatabase.net/k223809/ 2023-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k223809-precisiontavi-v11-fda-510k.jpg K223809 - PrecisionTAVI (v1.1) K223809 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Dasi Simulations. Cleared May 2023. https://www.510kdatabase.net/k223841/ 2023-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k223841-kba3d-fda-510k.jpg K223841 - KBA3D K223841 is a FDA 510(k) cleared radiology medical device. Manufacturer: S.M.A.I.O. Cleared May 2023. https://www.510kdatabase.net/k230030/ 2023-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k230030-excipio-sv-aspiration-catheter-and-fda-510k.jpg K230030 - Excipio SV Aspiration Catheter and Tubing K230030 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Contego Medical, Inc.. Cleared May 2023. https://www.510kdatabase.net/k230278/ 2023-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k230278-babyroo-tn300-fda-510k.jpg K230278 - Babyroo TN300 K230278 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Draeger Medical Systems, Inc.. Cleared May 2023. https://www.510kdatabase.net/k230571/ 2023-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k230571-rfp-100a-connector-cable-single-use-fda-510k.jpg K230571 - RFP-100A Connector Cable (Single Use) K230571 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baylis Medical Technologies, Inc.. Cleared May 2023. https://www.510kdatabase.net/k230593/ 2023-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k230593-victan-fda-510k.jpg K230593 - Victan K230593 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Jiangsu Haize Medical Scientific Development Co., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k230909/ 2023-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k230909-echotip-acucore-ultrasound-biopsy-fda-510k.jpg K230909 - EchoTip® AcuCore™ Ultrasound Biopsy Needle (ECHO-BX-3-22) K230909 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Ireland, Ltd.. Cleared May 2023. https://www.510kdatabase.net/k230958/ 2023-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k230958-first-glove-blue-nitrile-examination-fda-510k.jpg K230958 - First Glove Blue Nitrile Examination Gloves Powder Free K230958 is a FDA 510(k) cleared general hospital medical device. Manufacturer: First Glove Sdn. Bhd.. Cleared May 2023. https://www.510kdatabase.net/k230601/ 2023-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k230601-blue-nitrile-examination-gloves-powder-fda-510k.jpg K230601 - Blue Nitrile Examination Gloves Powder Free K230601 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Latrile Gloves Private Limited. Cleared May 2023. https://www.510kdatabase.net/k203599/ 2023-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k203599-image-navigator-by-immuno-concepts-fda-510k.jpg K203599 - Image Navigator by Immuno Concepts, Immuno Concepts IgG Anti-nDNA Fluorescent Test System K203599 is a FDA 510(k) cleared immunology medical device. Manufacturer: Immuno Concepts, N.A. , Ltd.. Cleared May 2023. https://www.510kdatabase.net/k213289/ 2023-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k213289-gammex-pi-plus-glove-in-glove-system-fda-510k.jpg K213289 - Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs K213289 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ansell Healthcare Products, LLC. Cleared May 2023. https://www.510kdatabase.net/k222606/ 2023-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k222606-v-hyadase-fda-510k.jpg K222606 - V-HYADASE K222606 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Vitromed GmbH. Cleared May 2023. https://www.510kdatabase.net/k222640/ 2023-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k222640-sweden-martina-surgical-trays-fda-510k.jpg K222640 - Sweden & Martina Surgical Trays K222640 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sweden & Martina S.P.A.. Cleared May 2023. https://www.510kdatabase.net/k223096/ 2023-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k223096-dark-star-deformity-pedicle-screw-system-fda-510k.jpg K223096 - Dark Star Deformity Pedicle Screw System K223096 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Republic Spine, LLC. Cleared May 2023. https://www.510kdatabase.net/k223329/ 2023-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k223329-electric-breast-pump-model-yy-a46-yy-fda-510k.jpg K223329 - Electric Breast Pump (model: YY-A46, YY-A203, YY-A204, YY-TC201) K223329 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Guangzhou Yongyi Industrial Co., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k223626/ 2023-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k223626-niti-s-biliary-speed-d-stent-fda-510k.jpg K223626 - Niti-S Biliary Speed D Stent K223626 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Taewoong Medical Co., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k223651/ 2023-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k223651-cerebral-adaptive-index-cai-algorithm-fda-510k.jpg K223651 - Cerebral Adaptive Index (CAI) Algorithm K223651 is a FDA 510(k) cleared neurology medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared May 2023. https://www.510kdatabase.net/k230044/ 2023-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k230044-pre-sure-fda-510k.jpg K230044 - Pre-Sure K230044 is a FDA 510(k) cleared radiology medical device. Manufacturer: Lazarus 3D. Cleared May 2023. https://www.510kdatabase.net/k230065/ 2023-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k230065-vensure-balloon-dilation-system-fda-510k.jpg K230065 - VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation System K230065 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Fiagon GmbH. Cleared May 2023. https://www.510kdatabase.net/k230111/ 2023-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k230111-core-500-digital-stethoscope-fda-510k.jpg K230111 - CORE 500 Digital Stethoscope K230111 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Eko Devices, Inc.. Cleared May 2023. https://www.510kdatabase.net/k230263/ 2023-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k230263-finesse-injectable-pta-balloon-fda-510k.jpg K230263 - Finesse™ Injectable PTA Balloon Dilatation Catheter K230263 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Summa Therapeutics, LLC. Cleared May 2023. https://www.510kdatabase.net/k230316/ 2023-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k230316-flexband-fda-510k.jpg K230316 - FlexBand K230316 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: International Life Sciences. Cleared May 2023. https://www.510kdatabase.net/k230557/ 2023-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k230557-eclipse-treatment-planning-system-v180-fda-510k.jpg K230557 - Eclipse Treatment Planning System (v18.0) K230557 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared May 2023. https://www.510kdatabase.net/k230580/ 2023-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k230580-diode-laser-system-fda-510k.jpg K230580 - Diode Laser System K230580 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smedtrum Medical Technology Co., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k230679/ 2023-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k230679-wellsform-tricuspid-annuloplasty-band-wf-fda-510k.jpg K230679 - WellsForm Tricuspid Annuloplasty Band (WF) K230679 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Genesee Biomedical, Inc.. Cleared May 2023. https://www.510kdatabase.net/k230739/ 2023-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k230739-hand-held-ipl-device-ipl-home-use-hair-fda-510k.jpg K230739 - Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100, FZ-200 K230739 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Ionka Medical Technology Co., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k230851/ 2023-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k230851-kodiak-lumbar-spacer-system-fda-510k.jpg K230851 - Kodiak Lumbar Spacer System K230851 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Met One Technologies, LLC. Cleared May 2023. https://www.510kdatabase.net/k231184/ 2023-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k231184-cd-horizon-spinal-system-fda-510k.jpg K231184 - CD Horizon™ Spinal System K231184 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared May 2023. https://www.510kdatabase.net/k231233/ 2023-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k231233-identity-imprint-cr-krs-and-identity-fda-510k.jpg K231233 - Identity™ Imprint™ CR KRS and Identity™ Imprint™ PS KRS K231233 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Conformis, Inc.. Cleared May 2023. https://www.510kdatabase.net/k213256/ 2023-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k213256-thermotk-fda-510k.jpg K213256 - ThermoTK K213256 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Zimmer Medizinsysteme GmbH. Cleared May 2023. https://www.510kdatabase.net/k220759/ 2023-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k220759-armis-vericyn-wound-wash-fda-510k.jpg K220759 - Armis VeriCyn Wound Wash K220759 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Armis Biopharma, Inc.. Cleared May 2023. https://www.510kdatabase.net/k222229/ 2023-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k222229-advanced-lumfix-spinal-fixation-system-fda-510k.jpg K222229 - Advanced LumFix Spinal Fixation System K222229 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: CG Bio Co., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k222311/ 2023-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k222311-circa-matrix12-m-esophageal-fda-510k.jpg K222311 - CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System K222311 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Circa Scientific, Inc.. Cleared May 2023. https://www.510kdatabase.net/k222624/ 2023-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k222624-kls-martin-linos-wrist-system-fda-510k.jpg K222624 - KLS Martin LINOS Wrist System K222624 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: KLS-Martin L.P.. Cleared May 2023. https://www.510kdatabase.net/k222852/ 2023-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k222852-nipro-safetouch-needle-fda-510k.jpg K222852 - Nipro SafeTouch Needle K222852 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Nipro Medical Corporation. Cleared May 2023. https://www.510kdatabase.net/k222891/ 2023-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k222891-dental-desensitizer-fda-510k.jpg K222891 - Dental Desensitizer K222891 is a FDA 510(k) cleared dental medical device. Manufacturer: Guangzhou Beogene Biotech Co., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k223491/ 2023-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k223491-critical-care-suite-with-pneumothorax-fda-510k.jpg K223491 - Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite K223491 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems, LLC. Cleared May 2023. https://www.510kdatabase.net/k223814/ 2023-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k223814-genesis-active-implant-system-fda-510k.jpg K223814 - Genesis ACTIVE Implant System K223814 is a FDA 510(k) cleared dental medical device. Manufacturer: Keystone Dental, Inc.. Cleared May 2023. https://www.510kdatabase.net/k223818/ 2023-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k223818-model-9160-vitaloqub-fda-510k.jpg K223818 - Model 9160 VitaloQUB K223818 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Vitalograph (Ireland) , Ltd.. Cleared May 2023. https://www.510kdatabase.net/k230246/ 2023-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k230246-dentis-s-clean-sq-sl-narrow-implant-fda-510k.jpg K230246 - Dentis s-Clean SQ-SL Narrow Implant System K230246 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentis Co., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k230258/ 2023-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k230258-bb-8-sinus-dilation-kit-fda-510k.jpg K230258 - BB 8 Sinus Dilation Kit K230258 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Excelent, Inc.. Cleared May 2023. https://www.510kdatabase.net/k230259/ 2023-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k230259-soreal-press-soreal-cad-fda-510k.jpg K230259 - Soreal Press, Soreal CAD K230259 is a FDA 510(k) cleared dental medical device. Manufacturer: Shenzhen Up3D Technology Co., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k230273/ 2023-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k230273-saranas-early-bird-bleed-monitoring-fda-510k.jpg K230273 - Saranas Early Bird Bleed Monitoring System K230273 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Saranas, Inc.. Cleared May 2023. https://www.510kdatabase.net/k231169/ 2023-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k231169-sterlink-plus-sterilizer-with-sterload-fda-510k.jpg K231169 - STERLINK plus Sterilizer with STERLOAD Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) K231169 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Plasmapp Co,., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k231176/ 2023-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k231176-stingray-lp-catheter-fda-510k.jpg K231176 - Stingray LP Catheter K231176 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific. Cleared May 2023. https://www.510kdatabase.net/k231229/ 2023-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k231229-s-comp-reform-poct-navigation-fda-510k.jpg K231229 - S-COMP Reform® POCT Navigation Instruments K231229 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Precision Spine, Inc.. Cleared May 2023. https://www.510kdatabase.net/k221634/ 2023-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k221634-oxymag-transport-and-emergency-fda-510k.jpg K221634 - Oxymag - Transport and Emergency Ventilator K221634 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Magnamed Tecnologia Medica S/A. Cleared May 2023. https://www.510kdatabase.net/k222035/ 2023-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k222035-avatar-medical-software-v1-fda-510k.jpg K222035 - Avatar Medical Software V1 K222035 is a FDA 510(k) cleared radiology medical device. Manufacturer: Avatar Medical. Cleared May 2023. https://www.510kdatabase.net/k223259/ 2023-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k223259-coactiv-antimicrobial-wound-gel-fda-510k.jpg K223259 - coactiv+™ Antimicrobial Wound Gel K223259 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Kane Biotech, Inc.. Cleared May 2023. https://www.510kdatabase.net/k223620/ 2023-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k223620-reprieve-by-regenesistm-fda-510k.jpg K223620 - Reprieve by RegenesisTM K223620 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Regenesis Biomedical, Inc.. Cleared May 2023. https://www.510kdatabase.net/k223663/ 2023-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k223663-simda-abutment-fda-510k.jpg K223663 - SIMDA Abutment K223663 is a FDA 510(k) cleared dental medical device. Manufacturer: Simda Co., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k230106/ 2023-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k230106-general-cutting-straight-fda-510k.jpg K230106 - General Cutting Straight K230106 is a FDA 510(k) cleared dental medical device. Manufacturer: Nakanishi, Inc.. Cleared May 2023. https://www.510kdatabase.net/k230523/ 2023-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k230523-s-clean-link-abutment-narrow-fda-510k.jpg K230523 - s-Clean Link Abutment Narrow K230523 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentis Co., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k223504/ 2023-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k223504-ceribell-status-epilepticus-monitor-fda-510k.jpg K223504 - Ceribell Status Epilepticus Monitor K223504 is a FDA 510(k) cleared neurology medical device. Manufacturer: Ceribell, Inc.. Cleared May 2023. https://www.510kdatabase.net/k230096/ 2023-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k230096-genius-ai-detection-20-with-cc-mlo-fda-510k.jpg K230096 - Genius AI Detection 2.0 with CC-MLO Correlation K230096 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hologic, Inc.. Cleared May 2023. https://www.510kdatabase.net/k230134/ 2023-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k230134-laser-therapy-hair-growth-comb-model-fda-510k.jpg K230134 - Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002 K230134 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Hubei Yjt Technology Co.,Ltd. Cleared May 2023. https://www.510kdatabase.net/k230152/ 2023-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k230152-umr-omega-fda-510k.jpg K230152 - uMR Omega K230152 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k230564/ 2023-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k230564-green-non-sterile-powder-free-nitrile-fda-510k.jpg K230564 - Green Non Sterile Powder Free Nitrile Examination Gloves K230564 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Central Medicare Sdn Bhd. Cleared May 2023. https://www.510kdatabase.net/k230803/ 2023-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k230803-adas-3d-fda-510k.jpg K230803 - ADAS 3D K230803 is a FDA 510(k) cleared radiology medical device. Manufacturer: Adas3D Medical S.L.. Cleared May 2023. https://www.510kdatabase.net/k230874/ 2023-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k230874-syntheface-peek-interference-screw-fda-510k.jpg K230874 - Syntheface PEEK Interference Screw, Syntheface PEEK Screw Sheath K230874 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Suzhou Endophix Co., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k231162/ 2023-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k231162-rosa-hip-system-fda-510k.jpg K231162 - ROSA Hip System K231162 is a FDA 510(k) cleared radiology medical device. Manufacturer: Orthosoft Inc. (d/b/a) Zimmer CAS. Cleared May 2023. https://www.510kdatabase.net/k231178/ 2023-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k231178-actera-hip-system-fda-510k.jpg K231178 - ACTERA™ hip system K231178 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Conformis, Inc.. Cleared May 2023. https://www.510kdatabase.net/k220722/ 2023-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k220722-pvc-hydrophilic-urethral-catheter-fda-510k.jpg K220722 - PVC Hydrophilic Urethral Catheter K220722 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Well Lead Medical Co., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k222705/ 2023-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k222705-introducer-needle-fda-510k.jpg K222705 - Introducer Needle K222705 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Youcare Technology Co.,Ltd. (Wuhan). Cleared May 2023. https://www.510kdatabase.net/k223839/ 2023-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k223839-truebeam-truebeam-stx-edge-vitalbeam-fda-510k.jpg K223839 - TrueBeam, TrueBeam STx, Edge, VitalBeam K223839 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared May 2023. https://www.510kdatabase.net/k223860/ 2023-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k223860-integrity-bone-staple-fixation-system-fda-510k.jpg K223860 - Integrity™ Bone Staple Fixation System K223860 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Anika Therapeutics, Inc.. Cleared May 2023. https://www.510kdatabase.net/k230373/ 2023-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k230373-helios-785-pico-fda-510k.jpg K230373 - HELIOS 785 Pico K230373 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Laseroptek Co., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k230443/ 2023-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k230443-tens-ems-device-ly-et-01-ly-et-02-ly-fda-510k.jpg K230443 - TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04) K230443 is a FDA 510(k) cleared neurology medical device. Manufacturer: Jiangxi Royall Smart Technology Co., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k230460/ 2023-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k230460-laser-thermal-therapy-kit-fda-510k.jpg K230460 - Laser Thermal Therapy Kit K230460 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Elesta S.P.A. Cleared May 2023. https://www.510kdatabase.net/k230464/ 2023-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k230464-mixject-transfer-device-fda-510k.jpg K230464 - MixJect® Transfer Device K230464 is a FDA 510(k) cleared general hospital medical device. Manufacturer: West Pharma Services Il, Ltd.. Cleared May 2023. https://www.510kdatabase.net/k230465/ 2023-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k230465-hi-bond-universal-fda-510k.jpg K230465 - Hi-Bond Universal K230465 is a FDA 510(k) cleared dental medical device. Manufacturer: Mediclus Co., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k230631/ 2023-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k230631-kodiak-dual-port-coaxial-introducer-kit-fda-510k.jpg K230631 - Kodiak™ Dual Port Coaxial Introducer Kit K230631 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Argon Medical Devices. Cleared May 2023. https://www.510kdatabase.net/k230708/ 2023-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k230708-peridot-td-spacer-system-the-peridot-fda-510k.jpg K230708 - Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system) K230708 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Gbs Commonwealth Co., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k231168/ 2023-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k231168-tracstar-ldp-large-distal-platform-fda-510k.jpg K231168 - TracStar LDP Large Distal Platform K231168 is a FDA 510(k) cleared neurology medical device. Manufacturer: Imperative Care, Inc.. Cleared May 2023. https://www.510kdatabase.net/k231464/ 2023-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k231464-3m-clarity-aligners-3m-clarity-fda-510k.jpg K231464 - 3M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex) K231464 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company, Unitek Orthodontic Products. Cleared May 2023. https://www.510kdatabase.net/k212758/ 2023-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k212758-autoplaque-fda-510k.jpg K212758 - Autoplaque K212758 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cedars-Sinai Medical Center: Aim. Cleared May 2023. https://www.510kdatabase.net/k220402/ 2023-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k220402-virtuost-fda-510k.jpg K220402 - VirtuOst K220402 is a FDA 510(k) cleared radiology medical device. Manufacturer: O.N. Diagnostics. Cleared May 2023. https://www.510kdatabase.net/k220842/ 2023-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k220842-quantum-perfusion-centrifugal-blood-fda-510k.jpg K220842 - Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors K220842 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Qura S.R.L. Cleared May 2023. https://www.510kdatabase.net/k220916/ 2023-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k220916-ilet-dosing-decision-software-fda-510k.jpg K220916 - iLet® Dosing Decision Software K220916 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beta Bionics, Inc.. Cleared May 2023. https://www.510kdatabase.net/k221323/ 2023-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k221323-exactech-alteon-short-tapered-wedge-fda-510k.jpg K221323 - Exactech® Alteon® Short Tapered Wedge K221323 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared May 2023. https://www.510kdatabase.net/k222545/ 2023-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k222545-disposable-medical-mask-fda-510k.jpg K222545 - Disposable Medical Mask K222545 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guangzhou Fuzelong Hygiene Material Co., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k222703/ 2023-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k222703-atto-mobility-scooter-atto-fda-510k.jpg K222703 - ATTO Mobility Scooter (ATTO) K222703 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Moving Life, Ltd.. Cleared May 2023. https://www.510kdatabase.net/k222833/ 2023-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k222833-ventana-c-spinal-system-fda-510k.jpg K222833 - Ventana™ C Spinal System K222833 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinal Elements, Inc.. Cleared May 2023. https://www.510kdatabase.net/k222979/ 2023-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k222979-microlife-upper-arm-automatic-digital-fda-510k.jpg K222979 - Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3KV1-5W K222979 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Microlife Intellectual Property GmbH. Cleared May 2023. https://www.510kdatabase.net/k223486/ 2023-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k223486-safebreak-vascular-fda-510k.jpg K223486 - SafeBreak® Vascular K223486 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Lineus Medical. Cleared May 2023. https://www.510kdatabase.net/k223846/ 2023-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k223846-ilet-ace-pump-fda-510k.jpg K223846 - iLet® ACE Pump K223846 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beta Bionics, Inc.. Cleared May 2023. https://www.510kdatabase.net/k230375/ 2023-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k230375-biomonitor-iv-fda-510k.jpg K230375 - BIOMONITOR IV K230375 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biotronik, Inc.. Cleared May 2023. https://www.510kdatabase.net/k230416/ 2023-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k230416-triathlon-hinge-knee-system-fda-510k.jpg K230416 - Triathlon® Hinge Knee System K230416 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker. Cleared May 2023. https://www.510kdatabase.net/k230537/ 2023-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k230537-klassic-knee-revision-system-fda-510k.jpg K230537 - Klassic Knee Revision System K230537 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Total Joint Othopedics, Inc.. Cleared May 2023. https://www.510kdatabase.net/k230769/ 2023-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k230769-previsea-device-fda-510k.jpg K230769 - PrevisEA Device K230769 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Entac Medical, Inc.. Cleared May 2023. https://www.510kdatabase.net/k230790/ 2023-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k230790-alinity-i-total-b-hcg-reagent-kit-fda-510k.jpg K230790 - Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series K230790 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared May 2023. https://www.510kdatabase.net/k231137/ 2023-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k231137-xenta-drug-screen-cup-xenta-drug-fda-510k.jpg K231137 - Xenta Drug Screen Cup, Xenta Drug Screen Dipcard K231137 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Xenta Biomedical Science Co., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k231140/ 2023-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k231140-aprevo-transforaminal-lumbar-interbody-fda-510k.jpg K231140 - aprevo® transforaminal lumbar interbody fusion device K231140 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Carlsmed, Inc.. Cleared May 2023. https://www.510kdatabase.net/k231143/ 2023-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k231143-gi-genius-system-100-and-gi-genius-fda-510k.jpg K231143 - GI Genius System 100 and GI Genius System 200 K231143 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cosmo Artificial Intelligence - Ai, Ltd.. Cleared May 2023. https://www.510kdatabase.net/k220829/ 2023-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k220829-endo-motor-fda-510k.jpg K220829 - Endo Motor K220829 is a FDA 510(k) cleared dental medical device. Manufacturer: Foshan Coxo Medical Instrument Co., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k222356/ 2023-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k222356-claritag-advanced-fda-510k.jpg K222356 - Claritag Advanced K222356 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Dgi Technologies. Cleared May 2023. https://www.510kdatabase.net/k222578/ 2023-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k222578-3m-ioban-chg-chlorhexidine-gluconate-fda-510k.jpg K222578 - 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) K222578 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared May 2023. https://www.510kdatabase.net/k223269/ 2023-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k223269-spencer-probe-depth-electrodes-fda-510k.jpg K223269 - Spencer Probe Depth Electrodes K223269 is a FDA 510(k) cleared neurology medical device. Manufacturer: Ad-Tech Medical Instrument Corporation. Cleared May 2023. https://www.510kdatabase.net/k223276/ 2023-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k223276-anchor-bolts-as-accessories-to-depth-fda-510k.jpg K223276 - Anchor Bolts as Accessories to Depth Electrodes K223276 is a FDA 510(k) cleared neurology medical device. Manufacturer: Ad-Tech Medical Instrument Corporation. Cleared May 2023. https://www.510kdatabase.net/k223645/ 2023-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k223645-iv-administration-set-iv-extension-set-fda-510k.jpg K223645 - I.V. Administration Set, I.V. Extension Set K223645 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bq Plus Medical Co., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k223725/ 2023-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k223725-restrata-minimatrix-fda-510k.jpg K223725 - Restrata® MiniMatrix K223725 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Acera Surgical, Inc.. Cleared May 2023. https://www.510kdatabase.net/k230200/ 2023-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k230200-single-use-flexible-ureteroscope-fda-510k.jpg K230200 - Single-Use Flexible Ureteroscope K230200 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hunan Vathin Medical Instrument Co., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k230432/ 2023-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k230432-single-use-bipolar-forceps-fda-510k.jpg K230432 - Single Use Bipolar Forceps K230432 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Hg Innovations, Ltd.. Cleared May 2023. https://www.510kdatabase.net/k230453/ 2023-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k230453-opticrosstm-hd-coronary-imaging-fda-510k.jpg K230453 - OptiCrossTM HD Coronary Imaging Catheter, OptiCrossTM 6 HD Coronary Imaging Catheter K230453 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared May 2023. https://www.510kdatabase.net/k230479/ 2023-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k230479-comasp-cefiderocol-0008-128-fda-510k.jpg K230479 - ComASP Cefiderocol 0.008-128 K230479 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Liofilchem S. R. L.. Cleared May 2023. https://www.510kdatabase.net/k230723/ 2023-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k230723-c510gjusha-c510gc510jusha-c510-lcd-fda-510k.jpg K230723 - C510G/JUSHA-C510G/C510/JUSHA- C510 LCD Monitor K230723 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nanjing Jusha Display Technology Co., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k230758/ 2023-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k230758-umr-570-fda-510k.jpg K230758 - uMR 570 K230758 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k231113/ 2023-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k231113-arthrex-fibertak-suture-anchor-fda-510k.jpg K231113 - Arthrex FiberTak Suture Anchor K231113 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared May 2023. https://www.510kdatabase.net/den220027/ 2023-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/den220027-brahms-sflt-1-plgf-kryptor-test-system-fda-510k.jpg DEN220027 - B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test System DEN220027 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Brahms GmbH, Part of Thermo Fisher Scientific. Cleared May 2023. https://www.510kdatabase.net/k222728/ 2023-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k222728-radiation-planning-assistant-rpa-fda-510k.jpg K222728 - Radiation Planning Assistant (RPA) K222728 is a FDA 510(k) cleared radiology medical device. Manufacturer: University of Texas, MD Anderson Cancer Center. Cleared May 2023. https://www.510kdatabase.net/k223437/ 2023-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k223437-biodegradable-nitrile-powder-free-fda-510k.jpg K223437 - Biodegradable Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Fusion Colour) K223437 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hartalega NGC Sdn. Bhd.. Cleared May 2023. https://www.510kdatabase.net/k223696/ 2023-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k223696-fp-solo-mask-range-fda-510k.jpg K223696 - F&P Solo Mask Range K223696 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Fisher &Paykel Healthcare , Ltd.. Cleared May 2023. https://www.510kdatabase.net/k230286/ 2023-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k230286-assert-iq-insertable-cardiac-monitor-fda-510k.jpg K230286 - Assert-IQ™ Insertable Cardiac Monitor K230286 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared May 2023. https://www.510kdatabase.net/k230448/ 2023-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k230448-deepx-dermosight-dermatoscope-fda-510k.jpg K230448 - DeepX DermoSight Dermatoscope K230448 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Deepx Health, LLC. Cleared May 2023. https://www.510kdatabase.net/k231102/ 2023-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k231102-symbia-prospecta-va20a-family-fda-510k.jpg K231102 - Symbia Pro.specta VA20A Family K231102 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 2023. https://www.510kdatabase.net/k231128/ 2023-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k231128-juggerknot-soft-anchor-fda-510k.jpg K231128 - JuggerKnot Soft Anchor K231128 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Riverpoint Medical, LLC. Cleared May 2023. https://www.510kdatabase.net/k220964/ 2023-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k220964-versajet-hydrosurgery-system-iii-fda-510k.jpg K220964 - VERSAJET Hydrosurgery System (III) K220964 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew Medical Limited. Cleared May 2023. https://www.510kdatabase.net/k222024/ 2023-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k222024-evita-v800-evita-v600-fda-510k.jpg K222024 - Evita V800, Evita V600 K222024 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Draegerwerk AG & CO Kgaa. Cleared May 2023. https://www.510kdatabase.net/k222207/ 2023-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k222207-babylog-vn800-babylog-vn600-fda-510k.jpg K222207 - Babylog VN800, Babylog VN600 K222207 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Draegerwerk AG & CO Kgaa. Cleared May 2023. https://www.510kdatabase.net/k222254/ 2023-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k222254-gunther-tulip-vena-cava-filter-fda-510k.jpg K222254 - Gunther Tulip Vena Cava Filter Retrieval Set K222254 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared May 2023. https://www.510kdatabase.net/k222560/ 2023-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k222560-bluecheck-caries-detection-monitoring-fda-510k.jpg K222560 - BlueCheck™ Caries Detection & Monitoring K222560 is a FDA 510(k) cleared dental medical device. Manufacturer: Incisive Technologies Pty, Ltd.. Cleared May 2023. https://www.510kdatabase.net/k222736/ 2023-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k222736-panther-fusion-sars-cov-2flu-abrsv-assay-fda-510k.jpg K222736 - Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay K222736 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Hologic, Inc.. Cleared May 2023. https://www.510kdatabase.net/k222812/ 2023-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k222812-insufflator-fda-510k.jpg K222812 - Insufflator K222812 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Scivita Medical Technology Co., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k222912/ 2023-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k222912-c1trac-fda-510k.jpg K222912 - c1Trac K222912 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zimmer Medizinsysteme GmbH. Cleared May 2023. https://www.510kdatabase.net/k223893/ 2023-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k223893-infrared-heat-model-e0221-fda-510k.jpg K223893 - Infrared Heat (Model: E0221) K223893 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Light Tree Ventures Europe B.V.. Cleared May 2023. https://www.510kdatabase.net/k230219/ 2023-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k230219-eminent-spine-3d-lumbar-interbody-fda-510k.jpg K230219 - Eminent Spine 3D Lumbar Interbody Fusion Systems K230219 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Eminent Spine, LLC. Cleared May 2023. https://www.510kdatabase.net/k230262/ 2023-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k230262-bruxzir-incisal-coloring-liquid-fda-510k.jpg K230262 - BruxZir™ Incisal Coloring Liquid K230262 is a FDA 510(k) cleared dental medical device. Manufacturer: Prismatik Dentalcraft, Inc.. Cleared May 2023. https://www.510kdatabase.net/k230358/ 2023-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k230358-savi-dual-tm-migraine-therapy-fda-510k.jpg K230358 - SAVI Dual (TM) Migraine Therapy K230358 is a FDA 510(k) cleared neurology medical device. Manufacturer: Eneura, Inc.. Cleared May 2023. https://www.510kdatabase.net/k202993/ 2023-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k202993-buzzy-models-mini-healthcare-xl-fda-510k.jpg K202993 - Buzzy® (models: Mini Healthcare, XL Healthcare, Mini Personal, XL Personal, Pro) K202993 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Mmj Labs, LLC. Cleared May 2023. https://www.510kdatabase.net/k220526/ 2023-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k220526-hd12-hd15-fda-510k.jpg K220526 - HD+12, HD+15 K220526 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cardioline S.P.A. Cleared May 2023. https://www.510kdatabase.net/k222836/ 2023-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k222836-straumann-variobase-abutments-and-fda-510k.jpg K222836 - Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs K222836 is a FDA 510(k) cleared dental medical device. Manufacturer: Institut Straumann AG. Cleared May 2023. https://www.510kdatabase.net/k223836/ 2023-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k223836-vathin-video-bronchoscope-system-fda-510k.jpg K223836 - Vathin® Video Bronchoscope System K223836 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Hunan Vathin Medical Instrument Co., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k230121/ 2023-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k230121-nitrile-examination-gloves-powder-free-fda-510k.jpg K230121 - Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black) K230121 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Careglove Global Sdn. Bhd.. Cleared May 2023. https://www.510kdatabase.net/k231081/ 2023-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k231081-dexcom-g7-continuous-glucose-fda-510k.jpg K231081 - Dexcom G7 Continuous Glucose Monitoring (CGM) System K231081 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dexcom, Inc.. Cleared May 2023. https://www.510kdatabase.net/k231391/ 2023-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k231391-combi-touch-fda-510k.jpg K231391 - Combi Touch K231391 is a FDA 510(k) cleared dental medical device. Manufacturer: Mectron S.P.A.. Cleared May 2023. https://www.510kdatabase.net/k223147/ 2023-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k223147-myledmask-fda-510k.jpg K223147 - myLEDmask K223147 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Myblend. Cleared May 2023. https://www.510kdatabase.net/k223308/ 2023-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k223308-heating-tensems-ft-810r-fda-510k.jpg K223308 - HEATING TENS/EMS, FT-810R K223308 is a FDA 510(k) cleared neurology medical device. Manufacturer: Hivox Biotek, Inc.. Cleared May 2023. https://www.510kdatabase.net/k230217/ 2023-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k230217-sterile-polyisoprene-powder-free-fda-510k.jpg K230217 - Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs K230217 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Grand Work Plastic Products Co., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k221969/ 2023-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k221969-iu-implant-system-abutment-fda-510k.jpg K221969 - IU Implant System Abutment K221969 is a FDA 510(k) cleared dental medical device. Manufacturer: Warantec Co., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k222106/ 2023-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k222106-waypoint-gps-fda-510k.jpg K222106 - Waypoint GPS K222106 is a FDA 510(k) cleared neurology medical device. Manufacturer: Waypoint Orthopedics, Inc.. Cleared May 2023. https://www.510kdatabase.net/k222460/ 2023-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k222460-intraoperative-ultrasound-probe-cover-fda-510k.jpg K222460 - Intraoperative Ultrasound Probe Cover K222460 is a FDA 510(k) cleared radiology medical device. Manufacturer: Exact Medical Manufacturing. Cleared May 2023. https://www.510kdatabase.net/k222489/ 2023-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k222489-harvest-printable-resin-fda-510k.jpg K222489 - Harvest Printable Resin K222489 is a FDA 510(k) cleared dental medical device. Manufacturer: Harvest Dental Products, LLC. Cleared May 2023. https://www.510kdatabase.net/k222854/ 2023-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k222854-itflow-fda-510k.jpg K222854 - iTFlow K222854 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cardio Flow Design, Inc.. Cleared May 2023. https://www.510kdatabase.net/k223101/ 2023-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k223101-bd-secondary-infusion-set-fda-510k.jpg K223101 - BD Secondary Infusion Set K223101 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Care Fusion. Cleared May 2023. https://www.510kdatabase.net/k223706/ 2023-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k223706-pmma-block-fda-510k.jpg K223706 - PMMA BLOCK K223706 is a FDA 510(k) cleared dental medical device. Manufacturer: Huliang(Shanghai) Bio-Tech Co., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k230394/ 2023-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k230394-euroscrew-ng-fda-510k.jpg K230394 - EUROSCREW NG K230394 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Teknimed. Cleared May 2023. https://www.510kdatabase.net/k230414/ 2023-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k230414-clarivy-cervical-ibf-system-fda-510k.jpg K230414 - ClariVy™ Cervical IBF System K230414 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Vy Spine, LLC. Cleared May 2023. https://www.510kdatabase.net/k230684/ 2023-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k230684-radiforce-mx217-fda-510k.jpg K230684 - RadiForce MX217 K230684 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eizo Corporation. Cleared May 2023. https://www.510kdatabase.net/k230975/ 2023-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k230975-ahmed-glaucoma-valve-model-fp7-fda-510k.jpg K230975 - Ahmed® Glaucoma Valve Model FP7 K230975 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: New World Medical, Inc.. Cleared May 2023. https://www.510kdatabase.net/k231051/ 2023-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k231051-ahmed-glaucoma-valve-model-fp8-fda-510k.jpg K231051 - Ahmed® Glaucoma Valve Model FP8 K231051 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: New World Medical, Inc.. Cleared May 2023. https://www.510kdatabase.net/k231063/ 2023-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k231063-somavac-100-sustained-vacuum-system-fda-510k.jpg K231063 - SOMAVAC® 100 Sustained Vacuum System K231063 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Somavac Medical Solutions, Inc.. Cleared May 2023. https://www.510kdatabase.net/k231190/ 2023-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k231190-epiq-series-diagnostic-ultrasound-system-fda-510k.jpg K231190 - EPIQ Series Diagnostic Ultrasound System K231190 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Ultrasound, LLC. Cleared May 2023. https://www.510kdatabase.net/k231224/ 2023-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k231224-da-vinci-xi-surgical-system-is4000-da-fda-510k.jpg K231224 - da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) K231224 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared May 2023. https://www.510kdatabase.net/k220721/ 2023-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k220721-fx-coral-60-fx-coral-80-fx-coral-100-fda-510k.jpg K220721 - FX CorAL 60, FX CorAL 80, FX CorAL 100, FX CorAL 120, FX CorAL 600, FX CorAL 800, FX CorAL 1000 K220721 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC. Cleared May 2023. https://www.510kdatabase.net/k222501/ 2023-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k222501-regeneten-bioinductive-implant-fda-510k.jpg K222501 - Regeneten Bioinductive Implant K222501 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith and Nephew, Inc.. Cleared May 2023. https://www.510kdatabase.net/k222549/ 2023-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k222549-opentex-fda-510k.jpg K222549 - OpenTex K222549 is a FDA 510(k) cleared dental medical device. Manufacturer: Purgo Biologics, Inc.. Cleared May 2023. https://www.510kdatabase.net/k223265/ 2023-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k223265-cryox-vitrification-freeze-kit-thaw-kit-fda-510k.jpg K223265 - CryoX Vitrification Freeze Kit / Thaw Kit K223265 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Zhejiang Horizon Medical Technology Co., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k223623/ 2023-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k223623-subtlemr-23x-fda-510k.jpg K223623 - SubtleMR (2.3.x) K223623 is a FDA 510(k) cleared radiology medical device. Manufacturer: Subtle Medical, Inc.. Cleared May 2023. https://www.510kdatabase.net/k230280/ 2023-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k230280-andorate-suction-valve-and-andorate-fda-510k.jpg K230280 - ANDORATE® Suction Valve and ANDORATE® Biopsy Valve K230280 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Ga Health Company Limited. Cleared May 2023. https://www.510kdatabase.net/k230550/ 2023-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k230550-jaws-nitinol-staple-system-fda-510k.jpg K230550 - JAWS Nitinol Staple System K230550 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paragon 28, Inc.. Cleared May 2023. https://www.510kdatabase.net/k231052/ 2023-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k231052-exactrac-dynamic-112-fda-510k.jpg K231052 - ExacTrac Dynamic 1.1.2 K231052 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab AG. Cleared May 2023. https://www.510kdatabase.net/k220437/ 2023-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k220437-neurophet-aqua-fda-510k.jpg K220437 - Neurophet AQUA K220437 is a FDA 510(k) cleared radiology medical device. Manufacturer: Neurophet., Inc.. Cleared May 2023. https://www.510kdatabase.net/k221127/ 2023-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k221127-sientra-inc-portfinder-fda-510k.jpg K221127 - Sientra, inc. Portfinder K221127 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sientra, Inc.. Cleared May 2023. https://www.510kdatabase.net/k222870/ 2023-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k222870-transcutaneous-electrical-nerve-fda-510k.jpg K222870 - Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032, KTR-4012, KTR-4015, KTR-4029, KTR-4027, KTR-4026, KTR-4021, KTR-4034, KTR-4036, KTR-4037, KTR-4039 K222870 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Kentro Medical Electronics Co., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k222987/ 2023-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k222987-akunah-reflect-fda-510k.jpg K222987 - Akunah REFLECT K222987 is a FDA 510(k) cleared radiology medical device. Manufacturer: Akunah Pty, Ltd.. Cleared May 2023. https://www.510kdatabase.net/k223044/ 2023-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k223044-digital-thermometer-model-qt001-fda-510k.jpg K223044 - Digital Thermometer (Model QT001) K223044 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shen Zhen Rong Feng Technology Co., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k223318/ 2023-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k223318-internal-joint-stabilizer-elbow-fda-510k.jpg K223318 - Internal Joint Stabilizer - Elbow K223318 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Skeletal Dynamics, Inc.. Cleared May 2023. https://www.510kdatabase.net/k223624/ 2023-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k223624-emerald-herbst-fda-510k.jpg K223624 - Emerald Herbst K223624 is a FDA 510(k) cleared dental medical device. Manufacturer: Island Dental Lab, Inc Dba Emerald Dental. Cleared May 2023. https://www.510kdatabase.net/k230491/ 2023-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k230491-handx-monopolar-scissors-fda-510k.jpg K230491 - HandX™ Monopolar Scissors K230491 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Human Xtensions , Ltd.. Cleared May 2023. https://www.510kdatabase.net/k231032/ 2023-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k231032-amp-by-method-mobility-amp-plus-or-by-fda-510k.jpg K231032 - AMP by Method Mobility, AMP Plus (or +) by Method Mobility K231032 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Method Mobility. Cleared May 2023. https://www.510kdatabase.net/k231338/ 2023-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k231338-3m-clinpro-clear-21-sodium-fluoride-fda-510k.jpg K231338 - 3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment K231338 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Espe Dental Products. Cleared May 2023. https://www.510kdatabase.net/k212857/ 2023-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k212857-sterile-syringe-for-single-use-with-fda-510k.jpg K212857 - Sterile Syringe for Single Use (with Needle), Sterile Hypodermic Needle for Single Use K212857 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Zhiyu Medical Instrument Co, Ltd.. Cleared May 2023. https://www.510kdatabase.net/k222436/ 2023-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k222436-latitud-hip-replacement-system-fda-510k.jpg K222436 - Latitud™ Hip Replacement System K222436 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Meril Healthcare Pvt. , Ltd.. Cleared May 2023. https://www.510kdatabase.net/k222484/ 2023-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k222484-retitrack-fda-510k.jpg K222484 - Retitrack K222484 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: C. Light Technologies, Inc.. Cleared May 2023. https://www.510kdatabase.net/k222719/ 2023-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k222719-cx50n-fda-510k.jpg K222719 - CX50N K222719 is a FDA 510(k) cleared radiology medical device. Manufacturer: Wide Corporation. Cleared May 2023. https://www.510kdatabase.net/k223015/ 2023-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k223015-sterlink-fps-15s-plus-sterilizer-with-fda-510k.jpg K223015 - STERLINK™ FPS-15s Plus sterilizer with STERPACK™ plus cassette K223015 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Plasmapp Co,., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k223023/ 2023-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k223023-terragene-bionava-scbi-bt96-terragene-fda-510k.jpg K223023 - Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) K223023 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Plasmapp Co,., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k223025/ 2023-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k223025-tyvek-roll-with-ci-for-sterlink-fda-510k.jpg K223025 - Tyvek Roll with CI for STERLINK Sterilizer K223025 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Plasmapp Co,., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k223335/ 2023-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k223335-sirion-lateral-lumbar-interbody-system-fda-510k.jpg K223335 - SIRION Lateral Lumbar Interbody System K223335 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Astura Medical. Cleared May 2023. https://www.510kdatabase.net/k223655/ 2023-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k223655-catalyst-r1-reverse-shoulder-system-fda-510k.jpg K223655 - Catalyst R1 Reverse Shoulder System K223655 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Catalyst Orthoscience, Inc.. Cleared May 2023. https://www.510kdatabase.net/k223825/ 2023-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k223825-tens-ems-device-fda-510k.jpg K223825 - Tens & Ems Device K223825 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Shenzhen Jian Feng Electronic Technology Co., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k230721/ 2023-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k230721-atec-lateral-plate-system-fda-510k.jpg K230721 - ATEC Lateral Plate System K230721 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine, Inc.. Cleared May 2023. https://www.510kdatabase.net/den220083/ 2023-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/den220083-stanza-fda-510k.jpg DEN220083 - Stanza DEN220083 is a FDA 510(k) cleared neurology medical device. Manufacturer: Swing Therapeutics, Inc.. Cleared May 2023. https://www.510kdatabase.net/k222487/ 2023-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k222487-anika-tissue-tack-fixation-system-fda-510k.jpg K222487 - Anika Tissue Tack Fixation System K222487 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Anika Therapeutics, Inc.. Cleared May 2023. https://www.510kdatabase.net/k222716/ 2023-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k222716-mx50n-fda-510k.jpg K222716 - MX50N K222716 is a FDA 510(k) cleared radiology medical device. Manufacturer: Wide Corporation. Cleared May 2023. https://www.510kdatabase.net/k223280/ 2023-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k223280-disposible-nitrile-gloves-fda-510k.jpg K223280 - Disposible Nitrile Gloves K223280 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Holik Asia Group Co.,Ltd. Cleared May 2023. https://www.510kdatabase.net/k223428/ 2023-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k223428-electronic-stimulator-models-ulumb-fda-510k.jpg K223428 - Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B, uNeck-9512A, uNeck-9515A, uNeck-9517B, uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck-9529A, LQ-9535A) K223428 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Leqing Medical Instrument Co., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k230674/ 2023-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k230674-jo-water-based-anal-thick-lubricant-fda-510k.jpg K230674 - JO Water Based Anal Thick Lubricant 2oz Model 40112, JO Water Based Anal Thick Lubricant 4oz Model 40112, JO Water Based Anal Thick Lubricant 8oz Model 40114 K230674 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: CC Wellness, LLC. Cleared May 2023. https://www.510kdatabase.net/k202963/ 2023-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k202963-elec-master-elec-master-dual-fda-510k.jpg K202963 - ELEC Master, ELEC Master Dual K202963 is a FDA 510(k) cleared dental medical device. Manufacturer: Mgnewton , Ltd.. Cleared May 2023. https://www.510kdatabase.net/k220781/ 2023-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k220781-armada-ureteral-dilator-set-armada-fda-510k.jpg K220781 - ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer Catheter K220781 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Allwin Medical Devices, Inc.. Cleared May 2023. https://www.510kdatabase.net/k221768/ 2023-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k221768-oxfore100-hexafocon-a-rigid-gas-fda-510k.jpg K221768 - Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses K221768 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Paragon Vision Sciences, Inc.. Cleared May 2023. https://www.510kdatabase.net/k222926/ 2023-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k222926-arm-blood-pressure-monitor-model-fda-510k.jpg K222926 - Arm Blood Pressure Monitor, Model Name:111, Arm Blood Pressure Monitor, Model Name: B1681, Arm Blood Pressure Monitor, Model Name: B1682, Arm Blood Pressure Monitor, Model Name: B1683 K222926 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Yuezhongxing Technology Co., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k223858/ 2023-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k223858-lexa-mini-ris-303-ris-305-fda-510k.jpg K223858 - Lexa MINI (RIS-303, RIS-305) K223858 is a FDA 510(k) cleared general hospital medical device. Manufacturer: W&H Sterilization S.R.L.. Cleared May 2023. https://www.510kdatabase.net/k230351/ 2023-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k230351-led-facial-mask-fda-510k.jpg K230351 - LED Facial Mask K230351 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Sungpo Hi-Tech Electronic Co., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k230615/ 2023-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k230615-electric-scooter-model-s3312-fda-510k.jpg K230615 - Electric Scooter (Model: S3312) K230615 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Guangdong Prestige Technology Co., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k230616/ 2023-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k230616-polyguard-and-polyshield-safety-iv-fda-510k.jpg K230616 - Polyguard and Polyshield Safety IV Catheters K230616 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Poly Medicure Limited. Cleared May 2023. https://www.510kdatabase.net/k230637/ 2023-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k230637-wattson-temporary-pacing-guidewire-2250-fda-510k.jpg K230637 - Wattson temporary pacing guidewire (2250) K230637 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vascular Solutions, LLC. Cleared May 2023. https://www.510kdatabase.net/k230989/ 2023-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k230989-rod-registration-frame-fda-510k.jpg K230989 - Rod Registration Frame K230989 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared May 2023. https://www.510kdatabase.net/k231017/ 2023-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k231017-panther-fusion-advhmpvrv-assay-fda-510k.jpg K231017 - Panther Fusion AdV/hMPV/RV Assay K231017 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Hologic, Inc.. Cleared May 2023. https://www.510kdatabase.net/den210038/ 2023-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/den210038-vitros-immunodiagnostic-products-anti-fda-510k.jpg DEN210038 - VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator DEN210038 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Ortho-Clinical Diagnostics, Inc.. Cleared May 2023. https://www.510kdatabase.net/den210040/ 2023-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/den210040-vitros-immunodiagnostic-products-anti-fda-510k.jpg DEN210040 - VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators DEN210040 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Ortho-Clinical Diagnostics, Inc.. Cleared May 2023. https://www.510kdatabase.net/k203245/ 2023-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k203245-bladder-epicheck-dna-extraction-kit-fda-510k.jpg K203245 - Bladder EpiCheck DNA extraction kit, NX899090-01C, Bladder EpiCheck test kit, NX899090-02C, Bladder EpiCheck Software, NX899090-03C K203245 is a FDA 510(k) cleared medical genetics medical device. Manufacturer: Nucleix , Ltd.. Cleared May 2023. https://www.510kdatabase.net/k213280/ 2023-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k213280-bd-kiestra-methicillin-resistant-fda-510k.jpg K213280 - BD Kiestra Methicillin-resistant Staphylococcus aureus (MRSA) Application, BD Kiestra MRSA App K213280 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Kiestra B.V.. Cleared May 2023. https://www.510kdatabase.net/k220290/ 2023-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k220290-revitalair-430-fda-510k.jpg K220290 - Revitalair 430+ K220290 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Us Hyperbaric Network. Cleared May 2023. https://www.510kdatabase.net/k220322/ 2023-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k220322-pollogen-stop-u-model-uxv-device-fda-510k.jpg K220322 - Pollogen STOP U Model UXV Device K220322 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Pollogen, Ltd.. Cleared May 2023. https://www.510kdatabase.net/k220713/ 2023-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k220713-sol-guard-auto-disable-syringe-fda-510k.jpg K220713 - Sol-Guard Auto-disable Syringe K220713 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sol-Millennium Medical, Inc.. Cleared May 2023. https://www.510kdatabase.net/k221798/ 2023-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k221798-finger-pulse-oximeter-model-x1906p-fda-510k.jpg K221798 - Finger Pulse Oximeter, Model: X1906P K221798 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Changkun Technology Co., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k222097/ 2023-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k222097-olympic-deformity-band-system-fda-510k.jpg K222097 - OLYMPIC Deformity Band System K222097 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Astura Medical. Cleared May 2023. https://www.510kdatabase.net/k222388/ 2023-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k222388-swiftpro-system-fda-510k.jpg K222388 - swiftPro System K222388 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Emblation , Ltd.. Cleared May 2023. https://www.510kdatabase.net/k222847/ 2023-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k222847-ceramic-brackets-orthometric-fda-510k.jpg K222847 - Ceramic Brackets Orthometric K222847 is a FDA 510(k) cleared dental medical device. Manufacturer: Orthometric - Industria E Comercio DE Produtos Medicos. Cleared May 2023. https://www.510kdatabase.net/k223430/ 2023-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k223430-prolift-micro-expandable-spacer-system-fda-510k.jpg K223430 - ProLift Micro Expandable Spacer System K223430 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared May 2023. https://www.510kdatabase.net/k223756/ 2023-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k223756-simpro-now-gentlecath-hydrophilic-fda-510k.jpg K223756 - SimPro™ Now, GentleCath™ Hydrophilic K223756 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Dentsply Sirona. Cleared May 2023. https://www.510kdatabase.net/k223771/ 2023-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k223771-lumify-diagnostic-ultrasound-system-fda-510k.jpg K223771 - Lumify Diagnostic Ultrasound System K223771 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Ultrasound. Cleared May 2023. https://www.510kdatabase.net/k223805/ 2023-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k223805-agnes-fda-510k.jpg K223805 - Agnes K223805 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Agnes Medical Co., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k230082/ 2023-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k230082-auto-segmentation-fda-510k.jpg K230082 - Auto Segmentation K230082 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems, LLC. Cleared May 2023. https://www.510kdatabase.net/k230266/ 2023-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k230266-orchid-safety-release-valve-fda-510k.jpg K230266 - Orchid Safety Release Valve K230266 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Linear Health Sciences, LLC. Cleared May 2023. https://www.510kdatabase.net/k230340/ 2023-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k230340-lucas-plus-fda-510k.jpg K230340 - Lucas Plus K230340 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Amt Engineering Co., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k230530/ 2023-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k230530-sozo-pro-fda-510k.jpg K230530 - SOZO Pro K230530 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: ImpediMed Limited. Cleared May 2023. https://www.510kdatabase.net/k230531/ 2023-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k230531-sozo-pro-fda-510k.jpg K230531 - SOZO Pro K230531 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: ImpediMed Limited. Cleared May 2023. https://www.510kdatabase.net/k230619/ 2023-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k230619-hubly-electric-drill-h100-fda-510k.jpg K230619 - Hubly Electric Drill (H100) K230619 is a FDA 510(k) cleared neurology medical device. Manufacturer: Hubly, Inc.. Cleared May 2023. https://www.510kdatabase.net/k230653/ 2023-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k230653-smith-nephew-inc-anthem-total-knee-fda-510k.jpg K230653 - Smith & Nephew, Inc. ANTHEM Total Knee System, Genesis Uni Knee System, JOURNEY BCS and II Knee Systems, JOURNEY II CR Knee System, JOURNEY II Uni Knee System, Journey II UK Knee System, JOURNEY II XR Bi-Cruciate Retaining Knee System, JOURNEY PFJ System, JOURNEY Uni Knee System, Legion Hinge Total Knee System, Legion Total Knee System, ZUK Unicompartmental Knee System, ENGAGE Partial Knee System and Porous Patella and Porous Tibial Baseplates K230653 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared May 2023. https://www.510kdatabase.net/k230960/ 2023-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k230960-dlp-silicone-coronary-artery-ostial-fda-510k.jpg K230960 - DLP™ Silicone Coronary Artery Ostial Cannulae K230960 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared May 2023. https://www.510kdatabase.net/k230994/ 2023-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k230994-alinity-i-stat-high-sensitivity-fda-510k.jpg K230994 - Alinity i STAT High Sensitivity Troponin-I K230994 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories Diagnostics Division. Cleared May 2023. https://www.510kdatabase.net/k212743/ 2023-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k212743-medschenker-smart-transport-medium-fda-510k.jpg K212743 - MedSchenker Smart Transport Medium (STM15-A/STM20-A/STM30-A/SCS30-A) System K212743 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Medschenker, Inc.. Cleared May 2023. https://www.510kdatabase.net/k222421/ 2023-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k222421-sphincterotome-fda-510k.jpg K222421 - Sphincterotome K222421 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hangzhou AGS MedTech Co., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k223758/ 2023-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k223758-epione-fda-510k.jpg K223758 - Epione K223758 is a FDA 510(k) cleared radiology medical device. Manufacturer: Quantum Surgical Sas. Cleared May 2023. https://www.510kdatabase.net/k223843/ 2023-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k223843-flopatch-fp120-fda-510k.jpg K223843 - FloPatch FP120 K223843 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Flosonics Medical. Cleared May 2023. https://www.510kdatabase.net/k230123/ 2023-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k230123-apollo-knotless-suture-anchor-fda-510k.jpg K230123 - Apollo Knotless Suture Anchor K230123 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Maruho Medical. Cleared May 2023. https://www.510kdatabase.net/k230203/ 2023-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k230203-dentis-i-fix-abutment-fda-510k.jpg K230203 - Dentis I-FIX Abutment K230203 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentis Co., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k230655/ 2023-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k230655-peek-rci-screw-fda-510k.jpg K230655 - PEEK RCI Screw K230655 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Signature Orthopaedics Pty, Ltd.. Cleared May 2023. https://www.510kdatabase.net/k230934/ 2023-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k230934-viewflex-eco-reprocessed-ice-catheter-fda-510k.jpg K230934 - ViewFlex™ Eco Reprocessed ICE Catheter K230934 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared May 2023. https://www.510kdatabase.net/k230938/ 2023-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k230938-arix-humerus-system-fda-510k.jpg K230938 - ARIX Humerus System K230938 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Jeil Medical Corporation. Cleared May 2023. https://www.510kdatabase.net/k230948/ 2023-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k230948-bflex-2-slim-38-single-use-bronchoscope-fda-510k.jpg K230948 - BFlex™ 2 Slim 3.8 Single-Use Bronchoscope K230948 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Verathon Medical (Canada) Ulc. Cleared May 2023. https://www.510kdatabase.net/k212579/ 2023-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k212579-fortishield-biosynthetic-wound-matrix-fda-510k.jpg K212579 - FortiShield (Biosynthetic Wound Matrix) K212579 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Organogenesis, Inc.. Cleared May 2023. https://www.510kdatabase.net/k221779/ 2023-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k221779-asept-peritoneal-drainage-system-fda-510k.jpg K221779 - ASEPT Peritoneal Drainage System K221779 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Pfm Medical, Inc.. Cleared May 2023. https://www.510kdatabase.net/k223495/ 2023-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k223495-zeolite-hemostatic-cotton-fda-510k.jpg K223495 - Zeolite Hemostatic Cotton K223495 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Hangzhou Zeo-Innov Life Technology Co., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k223511/ 2023-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k223511-excella-navigation-instruments-fda-510k.jpg K223511 - Excella Navigation Instruments K223511 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Innovasis, Inc.. Cleared May 2023. https://www.510kdatabase.net/k223529/ 2023-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k223529-presson-spinal-fixation-system-fda-510k.jpg K223529 - PressON Spinal Fixation System K223529 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nexus Spine, LLC. Cleared May 2023. https://www.510kdatabase.net/k223907/ 2023-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k223907-nuera-tight-rf-model-apmd145m70-us-fda-510k.jpg K223907 - NuEra Tight RF Model APMD145.M70-US K223907 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bios S.R.L.. Cleared May 2023. https://www.510kdatabase.net/k230119/ 2023-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k230119-3d-anatomic-model-fda-510k.jpg K230119 - 3D Anatomic Model K230119 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ricoh USA, Inc.. Cleared May 2023. https://www.510kdatabase.net/k230292/ 2023-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k230292-samsung-ecg-monitor-application-with-fda-510k.jpg K230292 - Samsung ECG Monitor Application with Irregular Heart Rhythm Notification K230292 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Samsung Electronics Co., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k230606/ 2023-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k230606-acqmap-high-resolution-imaging-and-fda-510k.jpg K230606 - AcQMap® High Resolution Imaging and Mapping System K230606 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Acutus Medical, Inc.. Cleared May 2023. https://www.510kdatabase.net/k230614/ 2023-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k230614-cortium-fda-510k.jpg K230614 - Cortium™ K230614 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ulrich Medical USA. Cleared May 2023. https://www.510kdatabase.net/k230880/ 2023-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k230880-corelink-navigation-instruments-fda-510k.jpg K230880 - CoreLink Navigation Instruments K230880 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corelink, LLC. Cleared May 2023. https://www.510kdatabase.net/k230912/ 2023-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k230912-artix-bg-fda-510k.jpg K230912 - Artix BG K230912 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inari Medical. Cleared May 2023. https://www.510kdatabase.net/k230957/ 2023-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k230957-trisalus-trinav-lv-infusion-system-fda-510k.jpg K230957 - TriSalus TriNav® LV Infusion System K230957 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Trisalus Life Sciences. Cleared May 2023. https://www.510kdatabase.net/k230977/ 2023-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k230977-sis-system-fda-510k.jpg K230977 - SIS System K230977 is a FDA 510(k) cleared radiology medical device. Manufacturer: Surgical Information Sciences, Inc.. Cleared May 2023. https://www.510kdatabase.net/k221870/ 2023-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k221870-carnalife-holo-fda-510k.jpg K221870 - CarnaLife Holo K221870 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medapp S.A.. Cleared May 2023. https://www.510kdatabase.net/k222416/ 2023-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k222416-ria-safeguard-fda-510k.jpg K222416 - RIA Safeguard K222416 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ria Tech Co., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k223182/ 2023-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k223182-arial-dental-mistral-dental-amalgam-fda-510k.jpg K223182 - Arial Dental, Mistral Dental Amalgam, World Work Dental Amalgam, BMS Non Gamma 2 Alloy, Flexi Alloy, Hi-S Alloy, WW Dental Amalgam, Hi - Mix, Non Gamma 2 Alloy K223182 is a FDA 510(k) cleared dental medical device. Manufacturer: Worldwork S.R.L. Cleared May 2023. https://www.510kdatabase.net/k223595/ 2023-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k223595-vpatch-fda-510k.jpg K223595 - vPATCH K223595 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Virility Medical , Ltd.. Cleared May 2023. https://www.510kdatabase.net/k230643/ 2023-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k230643-cp620g-lcd-monitor-cp620-lcd-monitor-fda-510k.jpg K230643 - CP620G LCD monitor, CP620 LCD monitor K230643 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nanjing Jusha Display Technology Co., Ltd.. Cleared May 2023. https://www.510kdatabase.net/k213825/ 2023-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k213825-oxygen-concentrator-model-8f-3a-oxygen-fda-510k.jpg K213825 - Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A K213825 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Jiangsu Yuyue Medical Equipment& Supply Co., Ltd.. Cleared Apr 2023. https://www.510kdatabase.net/k220677/ 2023-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k220677-kurin-blood-culture-collection-set-fda-510k.jpg K220677 - Kurin Blood Culture Collection Set with Kurin Lock Technology K220677 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Kurin, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k221390/ 2023-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k221390-bnle-access-guidewire-fda-510k.jpg K221390 - BNLE Access Guidewire K221390 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biomerics Nle. Cleared Apr 2023. https://www.510kdatabase.net/k222004/ 2023-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k222004-integrate-c-interbody-fusion-system-fda-510k.jpg K222004 - INTEGRATE -C Interbody Fusion System K222004 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Happe Spine. Cleared Apr 2023. https://www.510kdatabase.net/k222636/ 2023-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k222636-et-abutment-system-fda-510k.jpg K222636 - ET Abutment System K222636 is a FDA 510(k) cleared dental medical device. Manufacturer: Hiossen, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k222934/ 2023-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k222934-nanoxarc-fda-510k.jpg K222934 - Nanox.ARC K222934 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nano-X Imaging , Ltd.. Cleared Apr 2023. https://www.510kdatabase.net/k223634/ 2023-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k223634-customized-abutment-fda-510k.jpg K223634 - Customized Abutment K223634 is a FDA 510(k) cleared dental medical device. Manufacturer: Arum Dentistry Co., Ltd.. Cleared Apr 2023. https://www.510kdatabase.net/k223677/ 2023-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k223677-titanium-abutment-blank-nobel-biocare-fda-510k.jpg K223677 - Titanium Abutment Blank Nobel Biocare N1 TCC K223677 is a FDA 510(k) cleared dental medical device. Manufacturer: Nobel Biocare AB. Cleared Apr 2023. https://www.510kdatabase.net/k223862/ 2023-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k223862-hair-boom-69-hair-boomair-hair-boom-fda-510k.jpg K223862 - Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUp K223862 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wontech Co., Ltd.. Cleared Apr 2023. https://www.510kdatabase.net/k230042/ 2023-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k230042-q-rejuvalight-pro-facewear-model-p19-fda-510k.jpg K230042 - Q-Rejuvalight Pro Facewear (Model: P19-0023) K230042 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Light Tree Ventures Europe B.V.. Cleared Apr 2023. https://www.510kdatabase.net/k230058/ 2023-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k230058-bladeless-trocar-artemis-lap-cannula-fda-510k.jpg K230058 - Bladeless Trocar – Artemis Lap Cannula K230058 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: T.A.G. Medical Products Corporation, Ltd.. Cleared Apr 2023. https://www.510kdatabase.net/k230480/ 2023-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k230480-weck-auto-endo5-5mm-automatic-fda-510k.jpg K230480 - Weck Auto Endo5 5mm Automatic Endoscopic 35cm Applier (AE05ML) K230480 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Teleflex Medical. Cleared Apr 2023. https://www.510kdatabase.net/k230597/ 2023-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k230597-aduro-comb-model-sz-22-sz-22a-sz-22b-fda-510k.jpg K230597 - Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B) K230597 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Light Tree Ventures Europe B.V.. Cleared Apr 2023. https://www.510kdatabase.net/k230600/ 2023-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k230600-veriton-ct-300-series-digital-spectct-fda-510k.jpg K230600 - VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364) K230600 is a FDA 510(k) cleared radiology medical device. Manufacturer: Spectrum Dynamics Medical, Ltd.. Cleared Apr 2023. https://www.510kdatabase.net/k230908/ 2023-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k230908-hand-trauma-threaded-nail-system-fda-510k.jpg K230908 - Hand Trauma Threaded Nail System K230908 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Skeletal Dynamics, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k230972/ 2023-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k230972-ingenia-elition-and-mr-7700-mr-systems-fda-510k.jpg K230972 - Ingenia Elition and MR 7700 MR Systems K230972 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Apr 2023. https://www.510kdatabase.net/k213078/ 2023-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k213078-myolift-qt-fda-510k.jpg K213078 - Myolift QT K213078 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Johari Digital Healthcare Limited. Cleared Apr 2023. https://www.510kdatabase.net/k221963/ 2023-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k221963-cumulus-functional-neurophysiology-fda-510k.jpg K221963 - Cumulus Functional Neurophysiology Platform K221963 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cumulus Neuroscience Limited. Cleared Apr 2023. https://www.510kdatabase.net/k221983/ 2023-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k221983-biodegradable-powder-free-nitrile-fda-510k.jpg K221983 - Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Biodegradable Powder Free Nitrile Examination Glove, Blue Violet Color, Biodegradable Powder Free Nitrile Examination Glove, Green Color K221983 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guangdong Kingfa Sci. & Tech.Co., Ltd.. Cleared Apr 2023. https://www.510kdatabase.net/k222352/ 2023-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k222352-epildream-hp-4000-med-fda-510k.jpg K222352 - Epildream HP 4000 MED K222352 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: D.E.A Project S.R.1.. Cleared Apr 2023. https://www.510kdatabase.net/k222381/ 2023-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k222381-peripro-femur-system-variable-angle-fda-510k.jpg K222381 - PeriPRO™ Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System K222381 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker GmbH. Cleared Apr 2023. https://www.510kdatabase.net/k222694/ 2023-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k222694-empro-eps-ep4514c-190-ep6514c-190-fda-510k.jpg K222694 - EmPro EPS (EP4514C-190, EP6514C-190) K222694 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: MicroVention, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k223210/ 2023-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k223210-clottriever-xl-catheter-fda-510k.jpg K223210 - ClotTriever XL Catheter K223210 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inari Medical, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k223212/ 2023-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k223212-precision-dl-fda-510k.jpg K223212 - Precision DL K223212 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Apr 2023. https://www.510kdatabase.net/k223398/ 2023-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k223398-gastric-alimetry-system-fda-510k.jpg K223398 - Gastric Alimetry System K223398 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Alimetry , Ltd.. Cleared Apr 2023. https://www.510kdatabase.net/k223520/ 2023-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k223520-unidrive-siii-system-fda-510k.jpg K223520 - UNIDRIVE SIII System K223520 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k223734/ 2023-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k223734-ent-em-fda-510k.jpg K223734 - ENT EM K223734 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Brainlab AG. Cleared Apr 2023. https://www.510kdatabase.net/k223892/ 2023-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k223892-dentmix-vps-impression-material-fda-510k.jpg K223892 - DentMix VPS Impression Material K223892 is a FDA 510(k) cleared dental medical device. Manufacturer: Innovative Product Brands, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k230272/ 2023-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k230272-renuvion-apr-handpiece-fda-510k.jpg K230272 - Renuvion® APR Handpiece K230272 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Apyx Medical Corporation. Cleared Apr 2023. https://www.510kdatabase.net/k230539/ 2023-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k230539-artisential-laparoscopic-instruments-fda-510k.jpg K230539 - ArtiSential Laparoscopic Instruments-Electrodes K230539 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Livsmed, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k230547/ 2023-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k230547-plumepen-elite-surgical-smoke-fda-510k.jpg K230547 - PlumePen Elite Surgical Smoke Evacuation Pencils, PlumePen Pro Surgical Smoke Evacuation Pencil, PlumePen Ultra Surgical Smoke Evacuation Pencils, PenAdapt Electrosurgical Pencil Adapter, SnapEvac Electrosurgical Pencil Adapter K230547 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Conmed Corporation. Cleared Apr 2023. https://www.510kdatabase.net/k230844/ 2023-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k230844-identity-imprint-cruciate-retaining-cr-fda-510k.jpg K230844 - Identity Imprint Cruciate Retaining (CR) Knee Replacement System (KRS) with Cruciate Sacrificing (CS) Insert K230844 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Conformis, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k230845/ 2023-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k230845-32hl512d-31hn713d-32hq713d-fda-510k.jpg K230845 - 32HL512D, 31HN713D, 32HQ713D K230845 is a FDA 510(k) cleared radiology medical device. Manufacturer: Lg Electronics.Inc. Cleared Apr 2023. https://www.510kdatabase.net/k230911/ 2023-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k230911-braun-skin-iexpert-fda-510k.jpg K230911 - Braun Skin i.expert K230911 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cyden Limited. Cleared Apr 2023. https://www.510kdatabase.net/k222548/ 2023-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k222548-endo-motor-fda-510k.jpg K222548 - Endo Motor K222548 is a FDA 510(k) cleared dental medical device. Manufacturer: Shenzhen Perfect Medical Instruments Co., Ltd.. Cleared Apr 2023. https://www.510kdatabase.net/k222584/ 2023-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k222584-evis-x1-video-system-center-olympus-cv-fda-510k.jpg K222584 - EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-1500, COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL/I, GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1100 K222584 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Medical Systems Corporation. Cleared Apr 2023. https://www.510kdatabase.net/k222996/ 2023-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k222996-access-pct-fda-510k.jpg K222996 - Access PCT K222996 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k223868/ 2023-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k223868-pyxis-3d-titanium-cage-system-fda-510k.jpg K223868 - PYXIS 3D Titanium Cage System K223868 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: GS Medical Co., Ltd.. Cleared Apr 2023. https://www.510kdatabase.net/k223932/ 2023-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k223932-safeair-combi-sfr-combi-us-fda-510k.jpg K223932 - SafeAir combi (SFR-combi-US) K223932 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Lina Medical Aps. Cleared Apr 2023. https://www.510kdatabase.net/k230499/ 2023-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k230499-artisential-laparoscopic-instruments-fda-510k.jpg K230499 - ArtiSential Laparoscopic Instruments-Electrodes K230499 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Livsmed, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k230552/ 2023-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k230552-mr-dwiflair-measurement-v10-fda-510k.jpg K230552 - MR DWI/FLAIR Measurement V1.0 K230552 is a FDA 510(k) cleared radiology medical device. Manufacturer: Olea Medical. Cleared Apr 2023. https://www.510kdatabase.net/k230553/ 2023-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k230553-linq-ii-insertable-cardiac-monitor-fda-510k.jpg K230553 - LINQ II Insertable Cardiac Monitor, CareLink SmartSync LINQ II ICM Application K230553 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k230829/ 2023-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k230829-tens7000-rechargeable-modeltens7000-fda-510k.jpg K230829 - TENS7000 Rechargeable (Model:TENS7000 Rechargeable) K230829 is a FDA 510(k) cleared neurology medical device. Manufacturer: Chongqing Rob Linka Science and Technology Co., Ltd.. Cleared Apr 2023. https://www.510kdatabase.net/k220513/ 2023-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k220513-nitro-interbody-fusion-cage-system-fda-510k.jpg K220513 - NITRO Interbody Fusion Cage System Family K220513 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ctl Medical Corporation. Cleared Apr 2023. https://www.510kdatabase.net/k222676/ 2023-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k222676-ceevra-reveal-3-fda-510k.jpg K222676 - Ceevra Reveal 3 K222676 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ceevra, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k223139/ 2023-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k223139-wallaby-017-micro-catheter-fda-510k.jpg K223139 - Wallaby 017 Micro Catheter K223139 is a FDA 510(k) cleared neurology medical device. Manufacturer: Wallaby Medical. Cleared Apr 2023. https://www.510kdatabase.net/k230056/ 2023-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k230056-mivu-esophageal-endo-cap-fda-510k.jpg K230056 - MiVu™ Esophageal Endo Cap K230056 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Diversatek Healthcare. Cleared Apr 2023. https://www.510kdatabase.net/k230202/ 2023-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k230202-tmini-miniature-robotic-system-fda-510k.jpg K230202 - TMINI™ Miniature Robotic System K230202 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: THINK Surgical, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k230204/ 2023-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k230204-alphalok-plating-system-fda-510k.jpg K230204 - ALPHALOK Plating System K230204 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Vilex, LLC. Cleared Apr 2023. https://www.510kdatabase.net/k230218/ 2023-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k230218-dd-solid-connect-cadcam-abutments-fda-510k.jpg K230218 - DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) K230218 is a FDA 510(k) cleared dental medical device. Manufacturer: Dental Direkt GmbH. Cleared Apr 2023. https://www.510kdatabase.net/k230223/ 2023-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k230223-icac-device-fda-510k.jpg K230223 - iCAC Device K230223 is a FDA 510(k) cleared radiology medical device. Manufacturer: Bunkerhill, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k230503/ 2023-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k230503-polaris-x-catheter-cable-blazer-dx-20-fda-510k.jpg K230503 - Polaris X™ Catheter Cable, Blazer™ Dx-20 Catheter Cable K230503 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific. Cleared Apr 2023. https://www.510kdatabase.net/k230549/ 2023-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k230549-ipl-hair-removal-device-models-fy-fda-510k.jpg K230549 - IPL Hair Removal Device, Model(s): FY-B505AL, FY-B505AG, FY-B505BL, FY-B505BG, FY-B507AL, FY-B507AG, FY-B507BL, FY-B507BG, FY-B508AL, FY-B508AG, FY-B508BL, FY-B508BG, FY-B509AL, FY-B509AG, FY-B509BL, FY-B509BG K230549 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Xiazhifeng Electronic Co., Ltd.. Cleared Apr 2023. https://www.510kdatabase.net/k230594/ 2023-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k230594-tigereye-st-cto-crossing-catheter-fda-510k.jpg K230594 - Tigereye ST CTO-Crossing Catheter K230594 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Avinger, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k230906/ 2023-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k230906-konicaminolta-di-x1-fda-510k.jpg K230906 - Konicaminolta DI-X1 K230906 is a FDA 510(k) cleared radiology medical device. Manufacturer: Konica Minolta, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k220261/ 2023-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k220261-nest-c-interbody-system-fda-510k.jpg K220261 - NEST-C Interbody System K220261 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paonan Biotech Co., Ltd.. Cleared Apr 2023. https://www.510kdatabase.net/k220274/ 2023-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k220274-kisar-stratford-si-screw-system-fda-510k.jpg K220274 - Kisar Stratford SI Screw System K220274 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Anjali Investments L.L.C. Cleared Apr 2023. https://www.510kdatabase.net/k222330/ 2023-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k222330-the-heart-seat-fda-510k.jpg K222330 - The Heart Seat K222330 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Casana Care, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k222690/ 2023-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k222690-smartguide-deflectable-hydrophilic-fda-510k.jpg K222690 - SmartGUIDE deflectable hydrophilic guidewire K222690 is a FDA 510(k) cleared neurology medical device. Manufacturer: Artiria Medical SA. Cleared Apr 2023. https://www.510kdatabase.net/k223141/ 2023-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k223141-str8-clear-aligner-fda-510k.jpg K223141 - STR8 Clear Aligner K223141 is a FDA 510(k) cleared dental medical device. Manufacturer: Str8 Oral Care. Cleared Apr 2023. https://www.510kdatabase.net/k223372/ 2023-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k223372-omnipod-go-insulin-delivery-device-fda-510k.jpg K223372 - Omnipod GO Insulin Delivery Device K223372 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Insulet Corporation. Cleared Apr 2023. https://www.510kdatabase.net/k230103/ 2023-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k230103-klockner-abutments-fda-510k.jpg K230103 - Klockner Abutments K230103 is a FDA 510(k) cleared dental medical device. Manufacturer: SOADCO, S.L.. Cleared Apr 2023. https://www.510kdatabase.net/k230136/ 2023-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k230136-trueview-200-pro-us-specimen-fda-510k.jpg K230136 - TrueView 200 Pro-US Specimen Radiography System (TrueView 200 Pro-US) K230136 is a FDA 510(k) cleared radiology medical device. Manufacturer: Compai Healthcare (Suzhou) Co.,Ltd. Cleared Apr 2023. https://www.510kdatabase.net/k230140/ 2023-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k230140-trueview-core-100pro-us-core-specimen-fda-510k.jpg K230140 - TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US) K230140 is a FDA 510(k) cleared radiology medical device. Manufacturer: Compai Healthcare (Suzhou) Co.,Ltd. Cleared Apr 2023. https://www.510kdatabase.net/k230704/ 2023-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k230704-rain-sheath-tibial-pedal-introducer-fda-510k.jpg K230704 - RAIN Sheath™ Tibial Pedal Introducer K230704 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis US Corp. Cleared Apr 2023. https://www.510kdatabase.net/k221142/ 2023-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k221142-kyphoplasty-balloon-system-fda-510k.jpg K221142 - Kyphoplasty Balloon System K221142 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OK Medinet Korea Co., Ltd.. Cleared Apr 2023. https://www.510kdatabase.net/k221742/ 2023-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k221742-conneqt-pulse-fda-510k.jpg K221742 - CONNEQT PULSE K221742 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Atcor Medical. Cleared Apr 2023. https://www.510kdatabase.net/k222210/ 2023-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k222210-aeon-endoscopic-stapler-fda-510k.jpg K222210 - AEON Endoscopic Stapler K222210 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lexington Medical, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k222291/ 2023-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k222291-paradigm-system-fda-510k.jpg K222291 - Paradigm System K222291 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Proprio, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k222604/ 2023-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k222604-dentona-flexisplint-optimill-fda-510k.jpg K222604 - dentona flexisplint, optimill memosplint, dentona vivatemp, optimill memosplint version S K222604 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentona AG. Cleared Apr 2023. https://www.510kdatabase.net/k223069/ 2023-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k223069-modular-rotating-hinge-knee-systems-fda-510k.jpg K223069 - Modular Rotating Hinge Knee Systems and Compatible Components K223069 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp., Dba Stryker Orthopaedics. Cleared Apr 2023. https://www.510kdatabase.net/k223300/ 2023-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k223300-estacore-pro-automatic-biopsy-needle-fda-510k.jpg K223300 - Estacore-Pro Automatic Biopsy Needle, Geotek Semiautomatic Biopsy Needle, Maxicore-M Automatic Biopsy Gun Needle, Maxicore-M Automatic Biopsy Needle and Instrument K223300 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Geotek Medikal Ltd Sti. Cleared Apr 2023. https://www.510kdatabase.net/k223501/ 2023-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k223501-viewfinder-software-version-11-fda-510k.jpg K223501 - ViewFinder Software Version 1.1 K223501 is a FDA 510(k) cleared radiology medical device. Manufacturer: Elaitra, Ltd.. Cleared Apr 2023. https://www.510kdatabase.net/k230084/ 2023-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k230084-hera-w10-diagnostic-ultrasound-system-fda-510k.jpg K230084 - HERA W10 Diagnostic Ultrasound System K230084 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Medison Co., Ltd.. Cleared Apr 2023. https://www.510kdatabase.net/k230468/ 2023-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k230468-ezdent-web-fda-510k.jpg K230468 - EzDent Web K230468 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ewoosoft Co., Ltd.. Cleared Apr 2023. https://www.510kdatabase.net/k230783/ 2023-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k230783-anatase-spine-surgery-navigation-system-fda-510k.jpg K230783 - Anatase Spine Surgery Navigation System K230783 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Remex Medical Corp.. Cleared Apr 2023. https://www.510kdatabase.net/k230789/ 2023-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k230789-knee-fda-510k.jpg K230789 - Knee+ K230789 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Pixee Medical. Cleared Apr 2023. https://www.510kdatabase.net/k230808/ 2023-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k230808-peek-sa-anterior-lumbar-interbody-fda-510k.jpg K230808 - PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System K230808 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Kyocera Medical Technologies, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k230811/ 2023-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k230811-digital-intraoral-x-ray-sensor-fda-510k.jpg K230811 - Digital Intraoral X-Ray Sensor K230811 is a FDA 510(k) cleared radiology medical device. Manufacturer: Iray Imaging Technology (Haining) Limited. Cleared Apr 2023. https://www.510kdatabase.net/k230816/ 2023-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k230816-intense-pulsed-light-treatment-system-fda-510k.jpg K230816 - Intense Pulsed Light Treatment System K230816 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shangdong Huamei Technology Co., Ltd.. Cleared Apr 2023. https://www.510kdatabase.net/k230819/ 2023-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k230819-omniguide-rfid-surgical-laser-fibers-fda-510k.jpg K230819 - OmniGuide RFID Surgical Laser Fibers K230819 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Omni-Guide Holdings, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k211153/ 2023-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k211153-inomax-dsir-fda-510k.jpg K211153 - Inomax DSIR K211153 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Mallinckrodt Manufacturing, LLC. Cleared Apr 2023. https://www.510kdatabase.net/k212220/ 2023-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k212220-artfx-spinal-fixation-system-fda-510k.jpg K212220 - ArtFX Spinal Fixation System K212220 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Artfx Medical, LLC. Cleared Apr 2023. https://www.510kdatabase.net/k220981/ 2023-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k220981-superplast-double-occluder-superplast-fda-510k.jpg K220981 - SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe K220981 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Fehling Surgical Instruments, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k222095/ 2023-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k222095-bashir-endovascular-catheter-ref-no-fda-510k.jpg K222095 - BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101 K222095 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Thrombolex, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k222261/ 2023-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k222261-flexible-video-choledochoscope-system-fda-510k.jpg K222261 - Flexible Video-Choledochoscope System K222261 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Shanghai SeeGen Photoelectric Technology Co., Ltd.. Cleared Apr 2023. https://www.510kdatabase.net/k223238/ 2023-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k223238-starband-3d-fda-510k.jpg K223238 - STARband 3D K223238 is a FDA 510(k) cleared neurology medical device. Manufacturer: Orthomerica Products, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k223287/ 2023-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k223287-velacur-fda-510k.jpg K223287 - Velacur K223287 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sonic Incytes. Cleared Apr 2023. https://www.510kdatabase.net/k223662/ 2023-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k223662-neodent-implant-system-helix-short-fda-510k.jpg K223662 - Neodent Implant System - Helix Short Surgical Kit Cases K223662 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jjgc Industria E Comercio DE Materiais Dentarios S.A.. Cleared Apr 2023. https://www.510kdatabase.net/k223768/ 2023-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k223768-radiforce-rx270-fda-510k.jpg K223768 - RadiForce RX270 K223768 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eizo Corporation. Cleared Apr 2023. https://www.510kdatabase.net/k230565/ 2023-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k230565-hiline-fixation-system-fda-510k.jpg K230565 - HILINE™ Fixation System K230565 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k230785/ 2023-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k230785-precision1-precision1-for-astigmatism-fda-510k.jpg K230785 - Precision1, Precision1 for Astigmatism K230785 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Alcon Laboratories, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k230807/ 2023-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k230807-deep-learning-image-reconstruction-fda-510k.jpg K230807 - Deep Learning Image Reconstruction K230807 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare Japan Corporation. Cleared Apr 2023. https://www.510kdatabase.net/den220082/ 2023-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/den220082-breast-implant-removal-device-bird-fda-510k.jpg DEN220082 - Breast Implant Removal Device (BIRD) DEN220082 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Gaylord Solutions, LLC. Cleared Apr 2023. https://www.510kdatabase.net/k211748/ 2023-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k211748-selux-ast-system-fda-510k.jpg K211748 - Selux AST System K211748 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Selux Diagnostics, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k220288/ 2023-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k220288-np-medical-npulse-k150-neutral-fda-510k.jpg K220288 - NP Medical nPulse K150 Neutral Displacement Needle Free Connector, nPulse Neutral displacement needle free connector, nPulse K150 Needle Free Connector K220288 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Np Medical, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k221042/ 2023-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k221042-renova-rp-centesis-pump-fda-510k.jpg K221042 - Renova RP Centesis Pump K221042 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Gi Supply, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k221220/ 2023-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k221220-montross-extremity-medical-hemi-fda-510k.jpg K221220 - Montross Extremity Medical Hemi Implant System K221220 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Montross Extremity Medical. Cleared Apr 2023. https://www.510kdatabase.net/k223168/ 2023-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k223168-tubing-and-accessories-sets-for-fda-510k.jpg K223168 - Tubing and Accessories Sets for Extracorporeal Membrane Oxygenation (ECMO) with Balance™ Biosurface K223168 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k223201/ 2023-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k223201-tap-lancet-fda-510k.jpg K223201 - TAP Lancet K223201 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Yourbio Health, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k223552/ 2023-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k223552-brainlab-elements-trajectory-planning-fda-510k.jpg K223552 - Brainlab Elements – Trajectory Planning (2.6), Elements Stereotaxy, Elements Lead Localization, Elements Trajectory Planning Cranial K223552 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Apr 2023. https://www.510kdatabase.net/k230023/ 2023-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k230023-art-plan-fda-510k.jpg K230023 - ART-Plan K230023 is a FDA 510(k) cleared radiology medical device. Manufacturer: Therapanacea Sas. Cleared Apr 2023. https://www.510kdatabase.net/k230053/ 2023-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k230053-simplifix-hip-system-fda-510k.jpg K230053 - SimpliFix Hip System K230053 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stabiliz Orthopaedics, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k230090/ 2023-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k230090-diode-laser-hair-removal-fda-510k.jpg K230090 - Diode Laser Hair Removal K230090 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wuhan Lotuxs Technology Co., Ltd.. Cleared Apr 2023. https://www.510kdatabase.net/k230766/ 2023-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k230766-altus-spine-monaco-pedicle-screw-system-fda-510k.jpg K230766 - Altus Spine Monaco Pedicle Screw System K230766 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Altus Spine. Cleared Apr 2023. https://www.510kdatabase.net/k213170/ 2023-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k213170-sensoseeg-depth-electrodes-fda-510k.jpg K213170 - SENSOSEEG Depth Electrodes K213170 is a FDA 510(k) cleared neurology medical device. Manufacturer: Sensomedical Labs, Ltd.. Cleared Apr 2023. https://www.510kdatabase.net/k221895/ 2023-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k221895-terumo-advanced-perfusion-system-1-fda-510k.jpg K221895 - Terumo Advanced Perfusion System 1 K221895 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Cardiovascular Systems Corporation. Cleared Apr 2023. https://www.510kdatabase.net/k223513/ 2023-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k223513-univy-osteovy-ti-cervical-ibf-system-fda-510k.jpg K223513 - UniVy™ OsteoVy™-Ti Cervical IBF System K223513 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Vy Spine, LLC. Cleared Apr 2023. https://www.510kdatabase.net/k223784/ 2023-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k223784-precision-tc2-precision-tc3-precision-fda-510k.jpg K223784 - Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200 K223784 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Deltronix Equipamentos Ltda. Cleared Apr 2023. https://www.510kdatabase.net/k230494/ 2023-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k230494-clottriever-bold-catheter-fda-510k.jpg K230494 - ClotTriever BOLD Catheter K230494 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inari Medical, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k230698/ 2023-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k230698-anivia-sg1000-pump-console-fda-510k.jpg K230698 - Anivia SG1000 Pump Console K230698 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Apmtd, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k230764/ 2023-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k230764-osteocentric-integrated-hip-fastener-fda-510k.jpg K230764 - OsteoCentric Integrated Hip Fastener System K230764 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OsteoCentric Technologies. Cleared Apr 2023. https://www.510kdatabase.net/k230820/ 2023-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k230820-sofwave-system-fda-510k.jpg K230820 - SofWave System K230820 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sofwave Medical, Ltd.. Cleared Apr 2023. https://www.510kdatabase.net/k222469/ 2023-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k222469-tib-abutments-fda-510k.jpg K222469 - TIB Abutments K222469 is a FDA 510(k) cleared dental medical device. Manufacturer: Southern Implants (Pty), Ltd.. Cleared Apr 2023. https://www.510kdatabase.net/k222829/ 2023-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k222829-curian-shiga-toxin-fda-510k.jpg K222829 - Curian® Shiga Toxin K222829 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Meridian Bioscience, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k223454/ 2023-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k223454-custom-made-invisible-aligners-fda-510k.jpg K223454 - Custom-made Invisible Aligners K223454 is a FDA 510(k) cleared dental medical device. Manufacturer: Zhejiang Yinchili Medical Technology Co., Ltd.. Cleared Apr 2023. https://www.510kdatabase.net/k223564/ 2023-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k223564-x-cube-50-x-cube-60-fda-510k.jpg K223564 - X-CUBE 50, X-CUBE 60 K223564 is a FDA 510(k) cleared radiology medical device. Manufacturer: Alpinion Medical Systems Co., Ltd.. Cleared Apr 2023. https://www.510kdatabase.net/k223577/ 2023-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k223577-localite-tms-navigator-ts-fda-510k.jpg K223577 - Localite TMS Navigator TS K223577 is a FDA 510(k) cleared neurology medical device. Manufacturer: Localite GmbH. Cleared Apr 2023. https://www.510kdatabase.net/k230429/ 2023-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k230429-tigertriever-21-revascularization-fda-510k.jpg K230429 - Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device K230429 is a FDA 510(k) cleared neurology medical device. Manufacturer: Rapid Medical , Ltd.. Cleared Apr 2023. https://www.510kdatabase.net/k230544/ 2023-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k230544-snugfit-all-suture-anchor-extension-fda-510k.jpg K230544 - SnugFit All-Suture Anchor extension K230544 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Apr 2023. https://www.510kdatabase.net/k230749/ 2023-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k230749-trimed-threaded-intramedullary-nail-fda-510k.jpg K230749 - TriMed Threaded Intramedullary Nail System K230749 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: TriMed, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k230772/ 2023-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k230772-quantib-prostate-fda-510k.jpg K230772 - Quantib Prostate K230772 is a FDA 510(k) cleared radiology medical device. Manufacturer: Quantib B.V.. Cleared Apr 2023. https://www.510kdatabase.net/den220059/ 2023-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/den220059-ntx100-tonic-motor-activation-ntx100-fda-510k.jpg DEN220059 - NTX100 Tonic Motor Activation (NTX100 ToMAc) System DEN220059 is a FDA 510(k) cleared neurology medical device. Manufacturer: Noctrix Health, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k213676/ 2023-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k213676-masimo-rad-g-with-temperature-fda-510k.jpg K213676 - Masimo Rad-G with Temperature K213676 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Masimo Corporation. Cleared Apr 2023. https://www.510kdatabase.net/k221974/ 2023-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k221974-epifinder-fda-510k.jpg K221974 - EpiFinder K221974 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Omeq Medical , Ltd.. Cleared Apr 2023. https://www.510kdatabase.net/k220345/ 2023-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k220345-sterlink-mini-sterilizer-with-sterload-fda-510k.jpg K220345 - STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer K220345 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Plasmapp Co,., Ltd.. Cleared Apr 2023. https://www.510kdatabase.net/k220854/ 2023-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k220854-trachcuff-cuff-controller-fda-510k.jpg K220854 - TrachCuff Cuff Controller K220854 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Aw Technologies Aps. Cleared Apr 2023. https://www.510kdatabase.net/k221865/ 2023-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k221865-btl-094-fda-510k.jpg K221865 - BTL-094 K221865 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: BTL Industries, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k222066/ 2023-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k222066-link-mobilelink-acetabular-cup-system-fda-510k.jpg K222066 - LINK MobileLink Acetabular Cup System K222066 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Waldemar Link GmbH & Co. KG. Cleared Apr 2023. https://www.510kdatabase.net/k223018/ 2023-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k223018-osprey-peripheral-iv-catheter-system-fda-510k.jpg K223018 - OSPREY PERIPHERAL IV Catheter System K223018 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Skydance Vascular, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k223509/ 2023-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k223509-compremium-compartment-compressibility-fda-510k.jpg K223509 - Compremium Compartment Compressibility Monitoring System (CPM#1) K223509 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Compremium AG. Cleared Apr 2023. https://www.510kdatabase.net/k223566/ 2023-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k223566-elita-femtosecond-laser-system-elita-fda-510k.jpg K223566 - ELITA™ Femtosecond Laser System, ELITA™ Patient Interface K223566 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Johnson & Johnson Surgical Vision, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k223705/ 2023-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k223705-endofliptm-300-fda-510k.jpg K223705 - EndoflipTM 300 K223705 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Covidien, LLC. Cleared Apr 2023. https://www.510kdatabase.net/k223785/ 2023-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k223785-n9-fda-510k.jpg K223785 - N9+ K223785 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nonagon , Ltd.. Cleared Apr 2023. https://www.510kdatabase.net/k230411/ 2023-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k230411-dragonfly-opstar-imaging-catheter-fda-510k.jpg K230411 - Dragonfly OpStar™ Imaging Catheter K230411 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared Apr 2023. https://www.510kdatabase.net/k230685/ 2023-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k230685-autocontour-model-radac-v3-fda-510k.jpg K230685 - AutoContour Model RADAC V3 K230685 is a FDA 510(k) cleared radiology medical device. Manufacturer: Radformation, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k193514/ 2023-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k193514-aution-max-ax-4060-urinalysis-system-fda-510k.jpg K193514 - AUTION MAX AX-4060 Urinalysis System K193514 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Arkray, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k213986/ 2023-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k213986-cerebralgo-plus-fda-510k.jpg K213986 - CerebralGo Plus K213986 is a FDA 510(k) cleared radiology medical device. Manufacturer: Yukun (Beijing) Technology Co., Ltd.. Cleared Apr 2023. https://www.510kdatabase.net/k220763/ 2023-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k220763-alpco-calprotectin-immunoturbidimetric-fda-510k.jpg K220763 - ALPCO Calprotectin Immunoturbidimetric Assay K220763 is a FDA 510(k) cleared immunology medical device. Manufacturer: ALPCO. Cleared Apr 2023. https://www.510kdatabase.net/k222185/ 2023-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k222185-stratus-infusion-catheter-fda-510k.jpg K222185 - Stratus Infusion Catheter K222185 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intervene, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k222200/ 2023-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k222200-cirrus-hd-oct-fda-510k.jpg K222200 - CIRRUS HD-OCT K222200 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Carl Zeiss Meditec, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k222350/ 2023-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k222350-sterile-nitrile-surgical-gloves-powder-fda-510k.jpg K222350 - Sterile Nitrile Surgical Gloves Powder Free K222350 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jr Engineering & Medical Technologies (M) Sdn. Bhd.. Cleared Apr 2023. https://www.510kdatabase.net/k222738/ 2023-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k222738-point-implant-system-fda-510k.jpg K222738 - Point implant system K222738 is a FDA 510(k) cleared dental medical device. Manufacturer: Pointnix Co., Ltd.. Cleared Apr 2023. https://www.510kdatabase.net/k223435/ 2023-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k223435-freestyle-libre-3-continuous-glucose-fda-510k.jpg K223435 - FreeStyle Libre 3 Continuous Glucose Monitoring System K223435 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Diabetes Care, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k223879/ 2023-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k223879-quantum-pureflow-standard-heat-fda-510k.jpg K223879 - Quantum PureFlow Standard Heat Exchangers (HX11W-S2, HX11W-S1M and HX11W-S2M) K223879 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quara S.R.L.. Cleared Apr 2023. https://www.510kdatabase.net/k230010/ 2023-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k230010-adseal-plus-fda-510k.jpg K230010 - ADSEAL Plus K230010 is a FDA 510(k) cleared dental medical device. Manufacturer: Meta Biomed Co., Ltd.. Cleared Apr 2023. https://www.510kdatabase.net/k230098/ 2023-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k230098-trusana-fda-510k.jpg K230098 - Trusana™ K230098 is a FDA 510(k) cleared dental medical device. Manufacturer: Myerson, LLC. Cleared Apr 2023. https://www.510kdatabase.net/k230143/ 2023-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k230143-dess-dental-smart-solutions-fda-510k.jpg K230143 - DESS Dental Smart Solutions K230143 is a FDA 510(k) cleared dental medical device. Manufacturer: Terrats Medical SL. Cleared Apr 2023. https://www.510kdatabase.net/k230264/ 2023-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k230264-ezra-flash-fda-510k.jpg K230264 - Ezra Flash K230264 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ezra Ai, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k230387/ 2023-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k230387-enseal-x1-curved-tissue-sealers-25-cm-fda-510k.jpg K230387 - ENSEAL X1 Curved Tissue Sealers, 25 cm shaft length (NSLX125C) K230387 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon Endo-Surgery, LLC. Cleared Apr 2023. https://www.510kdatabase.net/k230393/ 2023-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k230393-unicam-evo-software-fda-510k.jpg K230393 - UniCam Evo Software K230393 is a FDA 510(k) cleared radiology medical device. Manufacturer: Inter Medical Medizintechnik GmbH. Cleared Apr 2023. https://www.510kdatabase.net/k230412/ 2023-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k230412-symmed-elite-aesthetic-fda-510k.jpg K230412 - Symmed Elite Aesthetic K230412 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Termosalud. Cleared Apr 2023. https://www.510kdatabase.net/k230694/ 2023-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k230694-navicam-xpress-stomach-system-navicam-fda-510k.jpg K230694 - NaviCam Xpress Stomach System, NaviCam Xpress System K230694 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Anx Robotica Corp. Cleared Apr 2023. https://www.510kdatabase.net/k230719/ 2023-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k230719-biofire-spotfire-respiratory-r-panel-fda-510k.jpg K230719 - BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini K230719 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Biofire Diagnostics, LLC. Cleared Apr 2023. https://www.510kdatabase.net/k230868/ 2023-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k230868-spotfire-rsp-pos-neg-controls-spotfire-fda-510k.jpg K230868 - SPOTFIRE® RSP Pos & Neg Controls, SPOTFIRE® RSP Positive Control, SPOTFIRE® RSP Negative Control K230868 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Maine Molecular Quality Controls, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k220312/ 2023-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k220312-polyfusion-iv-administration-sets-fda-510k.jpg K220312 - Polyfusion IV Administration Sets K220312 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Poly Medicure Limited. Cleared Apr 2023. https://www.510kdatabase.net/k223332/ 2023-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k223332-task-force-core-fda-510k.jpg K223332 - Task Force CORE K223332 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cnsystems Medizintechnik GmbH. Cleared Apr 2023. https://www.510kdatabase.net/k223838/ 2023-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k223838-catalys-precision-laser-system-fda-510k.jpg K223838 - Catalys™ Precision Laser System K223838 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Amo Manufacturing USA, LLC. Cleared Apr 2023. https://www.510kdatabase.net/k230424/ 2023-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k230424-omnia-medical-coupler-a-anterior-fda-510k.jpg K230424 - Omnia Medical Coupler-A™ Anterior Lumbar Plate System K230424 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Omnia Medical, LLC. Cleared Apr 2023. https://www.510kdatabase.net/k221303/ 2023-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k221303-neuspera-nuity-system-fda-510k.jpg K221303 - Neuspera Nuity System K221303 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neuspera Medical, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k222781/ 2023-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k222781-augmento-fda-510k.jpg K222781 - Augmento K222781 is a FDA 510(k) cleared radiology medical device. Manufacturer: Deeptek Medical Imaging Private Limited. Cleared Apr 2023. https://www.510kdatabase.net/k222910/ 2023-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k222910-bronchoscope-system-fda-510k.jpg K222910 - Bronchoscope System K222910 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Shenzhen HugeMed Medical Technical Development Co., Ltd.. Cleared Apr 2023. https://www.510kdatabase.net/k223530/ 2023-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k223530-route-92-medical-full-length-070-fda-510k.jpg K223530 - Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set K223530 is a FDA 510(k) cleared neurology medical device. Manufacturer: Route 92 Medical, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k223763/ 2023-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k223763-zeptolink-iol-positioning-system-fda-510k.jpg K223763 - ZeptoLink IOL Positioning System K223763 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Centricity Vision, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k223830/ 2023-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k223830-ultrasound-system-2300-fda-510k.jpg K223830 - Ultrasound System 2300 K223830 is a FDA 510(k) cleared radiology medical device. Manufacturer: Bk Medical Aps. Cleared Apr 2023. https://www.510kdatabase.net/k230402/ 2023-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k230402-enroute-transcarotid-neuroprotection-fda-510k.jpg K230402 - ENROUTE® Transcarotid Neuroprotection System K230402 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Silk Road Medical. Cleared Apr 2023. https://www.510kdatabase.net/k230705/ 2023-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k230705-pot-ptca-balloon-dilatation-catheter-fda-510k.jpg K230705 - POT PTCA Balloon Dilatation Catheter K230705 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Brosmed Medical Co., Ltd.. Cleared Apr 2023. https://www.510kdatabase.net/k230732/ 2023-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k230732-eagle-ssaevo-slimd700-slim-fda-510k.jpg K230732 - Eagle S/Saevo Slim/D700 Slim K230732 is a FDA 510(k) cleared radiology medical device. Manufacturer: Alliage S/A Industrias Medica Odontol?gico.. Cleared Apr 2023. https://www.510kdatabase.net/k230753/ 2023-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k230753-rct800-fda-510k.jpg K230753 - RCT800 K230753 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ray Co., Ltd.. Cleared Apr 2023. https://www.510kdatabase.net/k230754/ 2023-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k230754-l12-led-light-source-with-aim-fda-510k.jpg K230754 - L12 LED Light Source with AIM K230754 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker. Cleared Apr 2023. https://www.510kdatabase.net/k222887/ 2023-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k222887-arm-blood-pressure-monitorautomatic-fda-510k.jpg K222887 - Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor K222887 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Famidoc Technology Company Limited. Cleared Apr 2023. https://www.510kdatabase.net/k223176/ 2023-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k223176-cleaner-plus-thrombectomy-system-fda-510k.jpg K223176 - Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration Catheter, Cleaner Plus™ Handpiece with 65cm Maceration Wire, Cleaner Plus™ Handpiece with 135cm Maceration Wire, Cleaner Plus™ Aspiration Canister K223176 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Argon Medical Devices, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k223550/ 2023-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k223550-dmx-fda-510k.jpg K223550 - DMX K223550 is a FDA 510(k) cleared radiology medical device. Manufacturer: Del Medical, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k230122/ 2023-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k230122-ipl-hair-removal-device-models-ui04sd-fda-510k.jpg K230122 - IPL Hair Removal Device, Model(s): UI04 SD, UI04 DG K230122 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Ulike Smart Electronics Co., Ltd.. Cleared Apr 2023. https://www.510kdatabase.net/k230164/ 2023-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k230164-tens-and-ems-stimulation-otc-fda-510k.jpg K230164 - TENS and EMS Stimulation (OTC) K230164 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Changsha Yuwen Medical Equipment Co., Ltd.. Cleared Apr 2023. https://www.510kdatabase.net/k230360/ 2023-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k230360-ipl-cooling-hair-removal-device-models-fda-510k.jpg K230360 - IPL Cooling Hair Removal Device, Model(s): NBB01, NBB02 K230360 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Jizhimei Technology Co., Ltd.. Cleared Apr 2023. https://www.510kdatabase.net/k230366/ 2023-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k230366-arthrex-univers-revers-monoblock-stem-fda-510k.jpg K230366 - Arthrex Univers Revers Monoblock Stem Size 4/33 K230366 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k230695/ 2023-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k230695-apro-70-catheter-and-alembic-fda-510k.jpg K230695 - APRO 70 Catheter and Alembic Aspiration Tubing K230695 is a FDA 510(k) cleared neurology medical device. Manufacturer: Alembic, LLC. Cleared Apr 2023. https://www.510kdatabase.net/k230699/ 2023-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k230699-aria-radiation-therapy-management-v180-fda-510k.jpg K230699 - ARIA Radiation Therapy Management (v18.0) K230699 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/den220033/ 2023-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/den220033-misha-knee-system-fda-510k.jpg DEN220033 - MISHA Knee System DEN220033 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Moximed, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k220456/ 2023-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k220456-elecsys-ft4-iv-fda-510k.jpg K220456 - Elecsys FT4 IV K220456 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Apr 2023. https://www.510kdatabase.net/k222909/ 2023-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k222909-axiostat-gauze-fda-510k.jpg K222909 - Axiostat Gauze K222909 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Advamedica, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k223052/ 2023-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k223052-peri-guard-and-supple-peri-guard-fda-510k.jpg K223052 - Peri-Guard and Supple Peri-Guard K223052 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Synovis Life Technologies, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k223088/ 2023-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k223088-bd-smartsite-needle-free-connector-fda-510k.jpg K223088 - BD SmartSite™ Needle-Free Connector K223088 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Care Fusion. Cleared Apr 2023. https://www.510kdatabase.net/k223373/ 2023-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k223373-enivo-fda-510k.jpg K223373 - Enivo™ K223373 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aroa Biosurgery , Ltd.. Cleared Apr 2023. https://www.510kdatabase.net/k223640/ 2023-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k223640-axoguard-ha-nerve-protector-agha12-fda-510k.jpg K223640 - Axoguard HA+ Nerve Protector (AGHA12) K223640 is a FDA 510(k) cleared neurology medical device. Manufacturer: Axogen Corporation. Cleared Apr 2023. https://www.510kdatabase.net/k223772/ 2023-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k223772-pro-plating-system-stryker-trauma-fda-510k.jpg K223772 - PRO Plating System, Stryker Trauma Pelvic Set (Matta) K223772 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker GmbH. Cleared Apr 2023. https://www.510kdatabase.net/k223816/ 2023-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k223816-dental-ct-scanner-axr-fda-510k.jpg K223816 - Dental CT Scanner AXR K223816 is a FDA 510(k) cleared radiology medical device. Manufacturer: Alliage S/A Industrias Medico Odontol?gica. Cleared Apr 2023. https://www.510kdatabase.net/k230064/ 2023-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k230064-mazor-x-system-mazor-x-stealth-edition-fda-510k.jpg K230064 - Mazor X System (Mazor X Stealth Edition) K230064 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Mazor Robotics , Ltd.. Cleared Apr 2023. https://www.510kdatabase.net/k230318/ 2023-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k230318-memo-3d-semirigid-annuloplasty-ring-fda-510k.jpg K230318 - Memo 3D Semirigid Annuloplasty Ring K230318 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Corcym S.r.l.. Cleared Apr 2023. https://www.510kdatabase.net/k230575/ 2023-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k230575-limbus-contour-fda-510k.jpg K230575 - Limbus Contour K230575 is a FDA 510(k) cleared radiology medical device. Manufacturer: Limbus Ai, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k230658/ 2023-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k230658-skout-system-fda-510k.jpg K230658 - SKOUT® system K230658 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Iterative Scopes, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/den210055/ 2023-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/den210055-the-n-sweat-patch-fda-510k.jpg DEN210055 - The N-SWEAT Patch DEN210055 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Candesant Biomedical, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k222023/ 2023-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k222023-rayflow-fda-510k.jpg K222023 - RayFlow K222023 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hexacath. Cleared Apr 2023. https://www.510kdatabase.net/k222197/ 2023-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k222197-fp-optiflow-junior-22-nasal-cannula-fda-510k.jpg K222197 - F&P Optiflow Junior 2/2+ Nasal Cannula Interface Range K222197 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Fisher &Paykel Healthcare , Ltd.. Cleared Apr 2023. https://www.510kdatabase.net/k222360/ 2023-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k222360-ai-rad-companion-cardiovascular-fda-510k.jpg K222360 - AI-Rad Companion (Cardiovascular) K222360 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions U.S.A.. Cleared Apr 2023. https://www.510kdatabase.net/k222739/ 2023-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k222739-disposable-insulin-pen-needle-fda-510k.jpg K222739 - Disposable Insulin Pen Needle K222739 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hantech Medical Device Co., Ltd.. Cleared Apr 2023. https://www.510kdatabase.net/k223458/ 2023-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k223458-ingenia-ingenia-cx-ingenia-elition-fda-510k.jpg K223458 - Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems K223458 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Apr 2023. https://www.510kdatabase.net/k223531/ 2023-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k223531-carescape-canvas-1000-carescape-canvas-fda-510k.jpg K223531 - CARESCAPE Canvas 1000, CARESCAPE Canvas Smart Display, CARESCAPE Canvas D19, F2 Frame (F2-01) K223531 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: GE Healthcare Finland Oy. Cleared Apr 2023. https://www.510kdatabase.net/k223774/ 2023-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k223774-contour-protgai-fda-510k.jpg K223774 - Contour ProtégéAI K223774 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mim Software, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k230069/ 2023-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k230069-sin-dental-implant-system-fda-510k.jpg K230069 - S.I.N. Dental Implant System K230069 is a FDA 510(k) cleared dental medical device. Manufacturer: S.I.N. ? Sistema DE Implante Nacional S.A.. Cleared Apr 2023. https://www.510kdatabase.net/k230097/ 2023-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k230097-ipl-hair-removal-device-models-bsxt101-fda-510k.jpg K230097 - IPL Hair Removal Device, Model(s): BSXT101, BSXT102, BSXT103, BSXT105, BSXT106, BSXT108 K230097 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Bsx Technology Electronics Co., Ltd.. Cleared Apr 2023. https://www.510kdatabase.net/k230169/ 2023-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k230169-empowr-revision-vvc-varus-valgus-fda-510k.jpg K230169 - EMPOWR Revision VVC+ (Varus / Valgus Constrained), e+ Tibial Insert K230169 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Encore Medical, L.P Dba Enovis. Cleared Apr 2023. https://www.510kdatabase.net/k230313/ 2023-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k230313-quantum-patient-specific-fda-510k.jpg K230313 - QUANTUM Patient Specific Instrumentation (PSI) System K230313 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: In2bones Sas. Cleared Apr 2023. https://www.510kdatabase.net/k230341/ 2023-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k230341-acrifix-fda-510k.jpg K230341 - ACRIFIX K230341 is a FDA 510(k) cleared dental medical device. Manufacturer: Deltamed GmbH. Cleared Apr 2023. https://www.510kdatabase.net/k230640/ 2023-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k230640-affinity-fusion-oxygenator-system-fda-510k.jpg K230640 - Affinity Fusion™ Oxygenator System K230640 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k211556/ 2023-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k211556-n2-fda-510k.jpg K211556 - N2 K211556 is a FDA 510(k) cleared dental medical device. Manufacturer: Megagen Implant Co., Ltd.. Cleared Apr 2023. https://www.510kdatabase.net/k214009/ 2023-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k214009-dkaptain-pta-high-pressure-balloon-fda-510k.jpg K214009 - D·Kaptain PTA High Pressure Balloon Dilatation Catheter K214009 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Dk Medical Technology Co., Ltd.. Cleared Apr 2023. https://www.510kdatabase.net/k221118/ 2023-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k221118-co2-mainstream-sensor-fda-510k.jpg K221118 - CO2 Mainstream Sensor K221118 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Draegerwerk AG & CO Kgaa. Cleared Apr 2023. https://www.510kdatabase.net/k221493/ 2023-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k221493-microscan-prompt-inoculation-system-d-fda-510k.jpg K221493 - MicroScan Prompt Inoculation System-D K221493 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k221537/ 2023-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k221537-nightwear-aligners-fda-510k.jpg K221537 - Nightwear Aligners K221537 is a FDA 510(k) cleared dental medical device. Manufacturer: Smylio, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k222012/ 2023-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k222012-faq-101-fda-510k.jpg K222012 - FAQ 101 K222012 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Foreo, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k222677/ 2023-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k222677-intermittent-nelaton-catheter-for-fda-510k.jpg K222677 - Intermittent nelaton catheter for single use K222677 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hangzhou Jimushi Meditech Co., Ltd.. Cleared Apr 2023. https://www.510kdatabase.net/k223256/ 2023-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k223256-optimos-cystotome-fda-510k.jpg K223256 - Optimos™ Cystotome K223256 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Taewoong Medical Co., Ltd.. Cleared Apr 2023. https://www.510kdatabase.net/k223310/ 2023-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k223310-antimicrobial-silicone-phmb-foam-wound-fda-510k.jpg K223310 - Antimicrobial Silicone PHMB Foam Wound Dressing K223310 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Advanced Medical Solutions Limited. Cleared Apr 2023. https://www.510kdatabase.net/k223630/ 2023-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k223630-reveal-linq-insertable-cardiac-monitor-fda-510k.jpg K223630 - Reveal LINQ Insertable Cardiac Monitor, LINQ II Insertable Cardiac Monitor, AccuRhythm AI ECG Classification System K223630 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k230033/ 2023-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k230033-da-vinci-sp-surgical-system-sp1098-fda-510k.jpg K230033 - Da Vinci SP Surgical System (SP1098) K230033 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k230035/ 2023-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k230035-biosci-disposable-virus-sampling-tubes-fda-510k.jpg K230035 - BioSci™ Disposable Virus Sampling Tubes K230035 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Shenzhen Dakewe Bio-Engineering Co., Ltd.. Cleared Apr 2023. https://www.510kdatabase.net/k230107/ 2023-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k230107-aimanfun-lumea-comfort-model-a-2788-a-fda-510k.jpg K230107 - Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588 K230107 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Kam Yuen Plastic Products , Ltd.. Cleared Apr 2023. https://www.510kdatabase.net/k230336/ 2023-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k230336-currentbody-skin-led-hair-fda-510k.jpg K230336 - CurrentBody Skin™ Led Hair Regrowth(Model: MZ-07) K230336 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Light Tree Ventures Europe B.V.. Cleared Apr 2023. https://www.510kdatabase.net/k230689/ 2023-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k230689-t-fix-3dsi-joint-fusion-system-fda-510k.jpg K230689 - T-FIX™ 3DSI Joint Fusion System K230689 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Cutting Edge Spine, LLC. Cleared Apr 2023. https://www.510kdatabase.net/k213584/ 2023-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k213584-reprocessed-nrg-transseptal-needle-fda-510k.jpg K213584 - Reprocessed NRG Transseptal Needle K213584 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Innovative Health, LLC. Cleared Apr 2023. https://www.510kdatabase.net/k220142/ 2023-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k220142-brm-digitalis-spacer-fda-510k.jpg K220142 - BRM Digitalis Spacer K220142 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Brm Extremities Srl. Cleared Apr 2023. https://www.510kdatabase.net/k230029/ 2023-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k230029-neurostar-advanced-therapy-system-fda-510k.jpg K230029 - NeuroStar Advanced Therapy System (Version 3.7) K230029 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neuronetics. Cleared Apr 2023. https://www.510kdatabase.net/k230385/ 2023-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k230385-ballancer-platinum-1222-fda-510k.jpg K230385 - Ballancer Platinum (1222) K230385 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Mego Afek. Cleared Apr 2023. https://www.510kdatabase.net/k213749/ 2023-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k213749-g7-dental-operative-unit-and-accessories-fda-510k.jpg K213749 - G7, Dental Operative Unit and Accessories K213749 is a FDA 510(k) cleared dental medical device. Manufacturer: Shinhung Company, Ltd.. Cleared Apr 2023. https://www.510kdatabase.net/k220454/ 2023-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k220454-vivally-system-wearable-non-invasive-fda-510k.jpg K220454 - Vivally System Wearable, Non-Invasive Neuromodulation System and Mobile Application K220454 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Avation Medical, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k221802/ 2023-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k221802-iswab-respiratory-tract-sample-fda-510k.jpg K221802 - iSWAB-Respiratory Tract Sample Collection Media-Extraction Less (iSWAB-RC-EL) K221802 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Mawi Dna Technologies. Cleared Apr 2023. https://www.510kdatabase.net/k222006/ 2023-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k222006-sclerotherapy-endoscopic-needles-fda-510k.jpg K222006 - Sclerotherapy & Endoscopic Needles K222006 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: G-Flex Europe Sprl. Cleared Apr 2023. https://www.510kdatabase.net/k222865/ 2023-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k222865-m-biopsy-surecore-automatic-disposable-fda-510k.jpg K222865 - M Biopsy /SureCore Automatic Disposable Biopsy Needle, M Biopsy /SureCore Semi-Automatic Disposable Biopsy Needle, M Biopsy /SureAim Coaxial Biopsy Needle K222865 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Canyon Medical, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k223240/ 2023-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k223240-annalise-enterprise-ctb-triage-trauma-fda-510k.jpg K223240 - Annalise Enterprise CTB Triage Trauma K223240 is a FDA 510(k) cleared radiology medical device. Manufacturer: Annalise-Ai Pty , Ltd.. Cleared Apr 2023. https://www.510kdatabase.net/k230028/ 2023-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k230028-kendall-scd-smartflow-controller-fda-510k.jpg K230028 - Kendall SCD SmartFlow Controller, Cardinal Health Element Sleeves, Kendall SCD Express Sleeves, Kendall SCD Express Foot Cuff, Kendall SCD Sequential Compression Comfort Sleeves, Kendall SCD SmartFlow Controller Tubing Assembly K230028 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cardinal Health200, LLC. Cleared Apr 2023. https://www.510kdatabase.net/k222370/ 2023-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k222370-spo2-extension-cable-fda-510k.jpg K222370 - SpO2 Extension Cable K222370 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Beijing Rongrui-Century Science & Technology Co., Ltd.. Cleared Apr 2023. https://www.510kdatabase.net/k221734/ 2023-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k221734-maxtec-maxo2-mep-fda-510k.jpg K221734 - Maxtec MaxO2 ME+p K221734 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Maxtec, LLC. Cleared Apr 2023. https://www.510kdatabase.net/k230568/ 2023-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k230568-fibertak-suture-anchor-fda-510k.jpg K230568 - FiberTak Suture Anchor K230568 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Apr 2023. https://www.510kdatabase.net/k211059/ 2023-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k211059-cereflow-v12-fda-510k.jpg K211059 - CereFlow™ V1.2 K211059 is a FDA 510(k) cleared radiology medical device. Manufacturer: Translational Mri, LLC. Cleared Mar 2023. https://www.510kdatabase.net/k213272/ 2023-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k213272-formus-hip-fda-510k.jpg K213272 - Formus Hip K213272 is a FDA 510(k) cleared radiology medical device. Manufacturer: Formus Labs, Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k213660/ 2023-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k213660-radally-fda-510k.jpg K213660 - RadAlly K213660 is a FDA 510(k) cleared radiology medical device. Manufacturer: Imaging Wave, LLC. Cleared Mar 2023. https://www.510kdatabase.net/k220068/ 2023-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k220068-butterfly-iqiq-ultrasound-system-fda-510k.jpg K220068 - Butterfly iQ/iQ+ Ultrasound System K220068 is a FDA 510(k) cleared radiology medical device. Manufacturer: Butterfly Network, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k220780/ 2023-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k220780-rovo-mechanical-thrombectomy-device-fda-510k.jpg K220780 - ROVO Mechanical Thrombectomy Device K220780 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: 2mg, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k223017/ 2023-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k223017-aplio-i900i800i700-diagnostic-fda-510k.jpg K223017 - Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 K223017 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Mar 2023. https://www.510kdatabase.net/k223570/ 2023-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k223570-sonoair-series-digital-color-doppler-fda-510k.jpg K223570 - SonoAir Series Digital Color Doppler Ultrasound System K223570 is a FDA 510(k) cleared radiology medical device. Manufacturer: CHISON Medical Technologies Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k223778/ 2023-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k223778-diode-laser-hair-removal-system-rd-fda-510k.jpg K223778 - Diode Laser Hair Removal System (RD-SLD600) K223778 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shanghai Omni Laser Skinology Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k230003/ 2023-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k230003-topzir-dental-zirconia-blank-dental-fda-510k.jpg K230003 - Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank K230003 is a FDA 510(k) cleared dental medical device. Manufacturer: Topzir Biotech Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k230021/ 2023-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k230021-ipl-hair-removal-device-models-ap10-fda-510k.jpg K230021 - IPL Hair Removal Device, Model(s): AP10, AP20, AP30, AP32 K230021 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Yangyi Technology ., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k230022/ 2023-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k230022-baxter-sigma-spectrum-infusion-pump-fda-510k.jpg K230022 - Baxter SIGMA Spectrum Infusion Pump with Master Drug Library K230022 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corporation. Cleared Mar 2023. https://www.510kdatabase.net/k230041/ 2023-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k230041-spectrum-iq-infusion-system-with-dose-fda-510k.jpg K230041 - Spectrum IQ Infusion System with Dose IQ Safety Software K230041 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corporation. Cleared Mar 2023. https://www.510kdatabase.net/k230238/ 2023-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k230238-bioeasy-u-catch-max-multi-drug-test-fda-510k.jpg K230238 - BIOEASY™ U-Catch MAX Multi-Drug Test Cup, BIOEASY™ U-Catch MAX Multi-Drug Test Cup Rx K230238 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Shenzhen Bioeasy Biotechnology Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k230274/ 2023-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k230274-medical-diode-laser-m2-fda-510k.jpg K230274 - Medical Diode Laser (M2) K230274 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wuhan Pioon Technology Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k230312/ 2023-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k230312-iris-airshuttle-fda-510k.jpg K230312 - Iris AirShuttle™ K230312 is a FDA 510(k) cleared radiology medical device. Manufacturer: Qfix. Cleared Mar 2023. https://www.510kdatabase.net/k230356/ 2023-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k230356-aspirex-thrombectomy-system-fda-510k.jpg K230356 - Aspirex™ Thrombectomy System K230356 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k230605/ 2023-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k230605-1788-4k-camera-system-with-advanced-fda-510k.jpg K230605 - 1788 4K Camera System with Advanced Imaging Modality K230605 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker. Cleared Mar 2023. https://www.510kdatabase.net/den200011/ 2023-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/den200011-masimo-safetynet-fda-510k.jpg DEN200011 - Masimo SafetyNet DEN200011 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Masimo Corporation. Cleared Mar 2023. https://www.510kdatabase.net/k220088/ 2023-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k220088-powder-free-nitrile-examination-glove-fda-510k.jpg K220088 - Powder Free Nitrile Examination Glove, Non-Sterile, and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate K220088 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Professional Latex Sdn Bhd. Cleared Mar 2023. https://www.510kdatabase.net/k221320/ 2023-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k221320-scanning-laser-ophthalmoscope-mirante-fda-510k.jpg K221320 - Scanning Laser Ophthalmoscope Mirante [SLO/OCT Model] with Image Filing Software NAVIS-EX K221320 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Nidek Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k221324/ 2023-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k221324-enza-o-titanium-lateral-anterior-fda-510k.jpg K221324 - ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF) K221324 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Camber Spine Technologies. Cleared Mar 2023. https://www.510kdatabase.net/k221872/ 2023-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k221872-itrack-advance-canaloplasty-fda-510k.jpg K221872 - ITrack Advance Canaloplasty Microcatheter with Advanced Delivery System K221872 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Nova Eye Inc. (Business Name Nova Eye Medical). Cleared Mar 2023. https://www.510kdatabase.net/k222112/ 2023-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k222112-comfort-marker-20-fda-510k.jpg K222112 - Comfort Marker 2.0 K222112 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medical Precision BV. Cleared Mar 2023. https://www.510kdatabase.net/k223326/ 2023-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k223326-axiom-psr-system-fda-510k.jpg K223326 - Axiom PSR System K223326 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Restor3d. Cleared Mar 2023. https://www.510kdatabase.net/k223342/ 2023-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k223342-motoband-cp-implant-system-dynabunion-fda-510k.jpg K223342 - MotoBAND™ CP Implant System: DynaBunion™ 4D Minimal-incision Bunion System, DynaMET™ Lesser TMT Fusion System K223342 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Crossroads Extremity Systems, LLC. Cleared Mar 2023. https://www.510kdatabase.net/k223377/ 2023-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k223377-biasurge-advanced-surgical-solution-fda-510k.jpg K223377 - BIASURGE Advanced Surgical Solution K223377 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Rochal Technologies, LLC. Cleared Mar 2023. https://www.510kdatabase.net/k223422/ 2023-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k223422-emory-cardiac-toolbox-43-fda-510k.jpg K223422 - Emory Cardiac Toolbox 4.3 K223422 is a FDA 510(k) cleared radiology medical device. Manufacturer: Syntermed. Cleared Mar 2023. https://www.510kdatabase.net/k223853/ 2023-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k223853-medartis-aptus-ulna-plates-fda-510k.jpg K223853 - Medartis APTUS® Ulna Plates K223853 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medartis AG. Cleared Mar 2023. https://www.510kdatabase.net/k223923/ 2023-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k223923-hopkins-telescopes-fda-510k.jpg K223923 - HOPKINS Telescopes K223923 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k230161/ 2023-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k230161-online-tdm-phenytoin-free-phenytoin-fda-510k.jpg K230161 - ONLINE TDM Phenytoin - Free Phenytoin application K230161 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Mar 2023. https://www.510kdatabase.net/k230555/ 2023-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k230555-cemented-tibia-baseplate-no-taper-with-fda-510k.jpg K230555 - Cemented Tibia Baseplate no Taper with JRNY Lock K230555 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k230590/ 2023-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k230590-ardo-bellis-fda-510k.jpg K230590 - ARDO Bellis K230590 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ardo Medical AG. Cleared Mar 2023. https://www.510kdatabase.net/k230636/ 2023-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k230636-maestro-microcatheter-fda-510k.jpg K230636 - Maestro Microcatheter K230636 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical System, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/den210039/ 2023-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/den210039-snoo-smart-sleeper-fda-510k.jpg DEN210039 - SNOO Smart Sleeper DEN210039 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Happiest Baby, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k212423/ 2023-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k212423-endodrill-model-x-fda-510k.jpg K212423 - EndoDrill® Model X K212423 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Bibbinstruments AB. Cleared Mar 2023. https://www.510kdatabase.net/k213815/ 2023-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k213815-sijoint3-fda-510k.jpg K213815 - SiJoin®T3 K213815 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Vgi Medical, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k221984/ 2023-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k221984-interview-xp-fda-510k.jpg K221984 - InterView XP K221984 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mediso Medical Imaging Systems, Lttd.. Cleared Mar 2023. https://www.510kdatabase.net/k222312/ 2023-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k222312-raystation-12a-fda-510k.jpg K222312 - RayStation 12A K222312 is a FDA 510(k) cleared radiology medical device. Manufacturer: RaySearch Laboratories AB (PUBL). Cleared Mar 2023. https://www.510kdatabase.net/k222397/ 2023-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k222397-kls-martin-level-one-rib-fixation-system-fda-510k.jpg K222397 - KLS Martin Level One Rib Fixation System K222397 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: KLS-Martin L.P.. Cleared Mar 2023. https://www.510kdatabase.net/k222485/ 2023-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k222485-smartrion-combialexandrite-long-pulsed-fda-510k.jpg K222485 - SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser K222485 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ids, Limited. Cleared Mar 2023. https://www.510kdatabase.net/k222871/ 2023-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k222871-stethophone-v1-fda-510k.jpg K222871 - Stethophone v1 K222871 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sparrow Acoustics, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k223305/ 2023-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k223305-trevo-nxt-provue-retriever-fda-510k.jpg K223305 - Trevo NXT ProVue Retriever K223305 is a FDA 510(k) cleared neurology medical device. Manufacturer: Stryker Neurovascular. Cleared Mar 2023. https://www.510kdatabase.net/k223611/ 2023-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k223611-calibrate-ltx-interbody-system-fda-510k.jpg K223611 - Calibrate LTX Interbody System K223611 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k223915/ 2023-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k223915-tactoset-fda-510k.jpg K223915 - Tactoset K223915 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Anika Therapeutics, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k223916/ 2023-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k223916-puma-g-system-fda-510k.jpg K223916 - PUMA-G System K223916 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Coaptech, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k230243/ 2023-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k230243-rosa-knee-system-fda-510k.jpg K230243 - ROSA® Knee System K230243 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthosoft D/B/A Zimmer Cas. Cleared Mar 2023. https://www.510kdatabase.net/k230527/ 2023-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k230527-wishbone-medical-plate-and-screw-system-fda-510k.jpg K230527 - WishBone Medical Plate and Screw System K230527 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wishbone Medical, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/den220030/ 2023-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/den220030-remeos-screw-lag-solid-fda-510k.jpg DEN220030 - RemeOs™ Screw LAG Solid DEN220030 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Bioretec, Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k213867/ 2023-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k213867-carestation-750750c-fda-510k.jpg K213867 - Carestation 750/750c K213867 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Datex-Ohmeda, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k220226/ 2023-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k220226-x-y-lubricating-jelly-fda-510k.jpg K220226 - X-Y Lubricating Jelly K220226 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: R&R Medical Corporation, Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k221921/ 2023-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k221921-dtx-studio-clinic-30-fda-510k.jpg K221921 - DTX Studio Clinic 3.0 K221921 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nobel Biocare AB. Cleared Mar 2023. https://www.510kdatabase.net/k221938/ 2023-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k221938-kls-martin-pure-pectus-system-fda-510k.jpg K221938 - KLS Martin Pure Pectus System K221938 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: KLS-Martin L.P.. Cleared Mar 2023. https://www.510kdatabase.net/k221995/ 2023-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k221995-gas-insufflator-fda-510k.jpg K221995 - Gas Insufflator K221995 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k222146/ 2023-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k222146-disposable-endoscopic-hemoclip-fda-510k.jpg K222146 - Disposable Endoscopic Hemoclip K222146 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Jiangsu Vedkang Medical Science and Technology Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k222174/ 2023-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k222174-radiolens-v10-fda-510k.jpg K222174 - RadioLens v1.0 K222174 is a FDA 510(k) cleared radiology medical device. Manufacturer: Synapsica. Cleared Mar 2023. https://www.510kdatabase.net/k222179/ 2023-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k222179-annalise-enterprise-cxr-triage-trauma-fda-510k.jpg K222179 - Annalise Enterprise CXR Triage Trauma K222179 is a FDA 510(k) cleared radiology medical device. Manufacturer: Annalise-Ai Pty , Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k222260/ 2023-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k222260-capenergy-c-equipment-rf-system-c25-fda-510k.jpg K222260 - Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500 K222260 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Capenergy Medical S.L.. Cleared Mar 2023. https://www.510kdatabase.net/k222268/ 2023-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k222268-annalise-enterprise-cxr-triage-trauma-fda-510k.jpg K222268 - Annalise Enterprise CXR Triage Trauma K222268 is a FDA 510(k) cleared radiology medical device. Manufacturer: Annalise-Ai Pty , Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k222729/ 2023-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k222729-electrical-scooter-wt-t4qp2-fda-510k.jpg K222729 - Electrical Scooter, WT-T4QP2 K222729 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Wu'S Tech Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k223343/ 2023-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k223343-magnetom-amira-fda-510k.jpg K223343 - MAGNETOM Amira K223343 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k223625/ 2023-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k223625-capnospot-pneumothorax-decompression-fda-510k.jpg K223625 - CapnoSpot™ Pneumothorax Decompression Indicator K223625 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Pneumeric, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k223928/ 2023-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k223928-intense-pulsed-light-ipl-system-model-fda-510k.jpg K223928 - Intense Pulsed Light (IPL) System, model: T023K, T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K K223928 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Fansizhe Science And Technology Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k230026/ 2023-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k230026-squale-fda-510k.jpg K230026 - SQUALE K230026 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Implanet, S.A.. Cleared Mar 2023. https://www.510kdatabase.net/k230251/ 2023-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k230251-reprocessed-ligasure-curved-small-jaw-fda-510k.jpg K230251 - Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) K230251 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker Sustainability Solutions. Cleared Mar 2023. https://www.510kdatabase.net/k230255/ 2023-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k230255-remanufactured-ligasure-exact-fda-510k.jpg K230255 - Remanufactured LigaSure Exact Dissector Without Nano-coating LF2019 K230255 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker Sustainability Solutions. Cleared Mar 2023. https://www.510kdatabase.net/k230271/ 2023-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k230271-isolis-cryoprobe-fda-510k.jpg K230271 - ISOLIS Cryoprobe K230271 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k230582/ 2023-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k230582-system-1-endo-liquid-chemical-fda-510k.jpg K230582 - SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 K230582 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Mar 2023. https://www.510kdatabase.net/k200452/ 2023-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k200452-meril-bonewax-fda-510k.jpg K200452 - Meril-Bonewax K200452 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: M/s. Meril Endo Surgery Private Limited.. Cleared Mar 2023. https://www.510kdatabase.net/k222746/ 2023-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k222746-overjet-caries-assist-fda-510k.jpg K222746 - Overjet Caries Assist K222746 is a FDA 510(k) cleared radiology medical device. Manufacturer: Overjet, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k223192/ 2023-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k223192-xt-stainglaze-fda-510k.jpg K223192 - XT Stain/Glaze K223192 is a FDA 510(k) cleared dental medical device. Manufacturer: Shenzhen Xiangtong Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k223365/ 2023-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k223365-rodin-palette-naturalizing-kit-fda-510k.jpg K223365 - RODIN Palette Naturalizing Kit K223365 is a FDA 510(k) cleared dental medical device. Manufacturer: Belport Company, Inc., Gingi-Pak. Cleared Mar 2023. https://www.510kdatabase.net/k223581/ 2023-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k223581-solero-microwave-tissue-ablation-mta-fda-510k.jpg K223581 - Solero Microwave Tissue Ablation (MTA) System and Accessories K223581 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: AngioDynamics, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k223823/ 2023-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k223823-disposable-surgical-face-mask-fda-510k.jpg K223823 - Disposable Surgical Face Mask K223823 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Efofex, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k223882/ 2023-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k223882-narrowband-uv-phototherapy-light-lamp-fda-510k.jpg K223882 - Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02) K223882 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Honpal Optoelectronic Technology Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k220644/ 2023-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k220644-non-sterile-powder-free-ambidextrous-fda-510k.jpg K220644 - Non-sterile, Powder Free, ambidextrous, textured, beaded cuff, single use, Doffy® Nitrile Examination Glove, Tested for use with Chemotherapy Drugs K220644 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Yty Industry (Manjung) Sdn Bhd. Cleared Mar 2023. https://www.510kdatabase.net/k230046/ 2023-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k230046-vinyl-examination-gloves-fda-510k.jpg K230046 - Vinyl examination gloves K230046 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guangdong Kingfa Sci. & Tech.Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k220212/ 2023-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k220212-bd-vacutainer-push-button-blood-fda-510k.jpg K220212 - BD Vacutainer® Push Button Blood Collection Set, BD Vacutainer® Push Button Blood Collection Set with Pre-Attached Holder K220212 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson and Company. Cleared Mar 2023. https://www.510kdatabase.net/k221589/ 2023-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k221589-starly-pad-fda-510k.jpg K221589 - Starly pad K221589 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Xingyuanli Technology Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k222559/ 2023-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k222559-bd-bactec-mycof-lytic-culture-vials-fda-510k.jpg K222559 - BD BACTEC™ Myco/F Lytic Culture Vials K222559 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson and Company. Cleared Mar 2023. https://www.510kdatabase.net/k222591/ 2023-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k222591-bd-bactec-plus-aerobicf-culture-vials-fda-510k.jpg K222591 - BD BACTEC™ Plus Aerobic/F Culture Vials K222591 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson and Company. Cleared Mar 2023. https://www.510kdatabase.net/k223076/ 2023-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k223076-bd-texium-closed-male-luer-fda-510k.jpg K223076 - BD Texium™ Closed Male Luer K223076 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Care Fusion. Cleared Mar 2023. https://www.510kdatabase.net/k223236/ 2023-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k223236-medline-surgical-face-mask-and-medline-fda-510k.jpg K223236 - Medline Surgical Face Mask and Medline Procedural Face Mask K223236 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, LP. Cleared Mar 2023. https://www.510kdatabase.net/k223323/ 2023-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k223323-blood-collection-needle-withwithout-fda-510k.jpg K223323 - Blood Collection Needle (with/without Needle Holder) K223323 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k223803/ 2023-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k223803-canary-tibial-extension-cte-with-fda-510k.jpg K223803 - Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System K223803 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Canary Medical USA, LLC. Cleared Mar 2023. https://www.510kdatabase.net/k230002/ 2023-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k230002-nitrile-powder-free-black-patient-fda-510k.jpg K230002 - Nitrile Powder Free Black Patient Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs K230002 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Mah Sing Healthcare Sdn. Bhd.. Cleared Mar 2023. https://www.510kdatabase.net/k230206/ 2023-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k230206-entarik-feeding-tube-system-fda-510k.jpg K230206 - Entarik Feeding Tube System K230206 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Gravitas Medical, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k230382/ 2023-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k230382-3-series-neolux-fda-510k.jpg K230382 - 3 Series NeoLux K230382 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Daavlin Distributing Co.. Cleared Mar 2023. https://www.510kdatabase.net/k230461/ 2023-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k230461-quantra-hemostasis-analyzer-fda-510k.jpg K230461 - Quantra Hemostasis Analyzer K230461 is a FDA 510(k) cleared hematology medical device. Manufacturer: Hemosonics, LLC. Cleared Mar 2023. https://www.510kdatabase.net/k230474/ 2023-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k230474-eva5-insufflator-fda-510k.jpg K230474 - EVA5 Insufflator K230474 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Palliare , Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k230797/ 2023-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k230797-smartmta-capsule-fda-510k.jpg K230797 - SmartMTA Capsule K230797 is a FDA 510(k) cleared dental medical device. Manufacturer: Sprig Oral Health Technologies, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k212121/ 2023-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k212121-vht-200-wound-treatment-system-fda-510k.jpg K212121 - VHT-200 Wound Treatment System K212121 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Vaporox, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k212207/ 2023-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k212207-sterile-hypodermic-syringe-for-single-fda-510k.jpg K212207 - Sterile Hypodermic Syringe for Single Use K212207 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shandong Weigao Group Medical Polymer Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k212394/ 2023-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k212394-implant-one-multi-unit-abutment-fda-510k.jpg K212394 - Implant-One Multi-Unit Abutment K212394 is a FDA 510(k) cleared dental medical device. Manufacturer: Implant Logistics, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k221585/ 2023-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k221585-3m-vac-veraflo-cleanse-choice-dressing-fda-510k.jpg K221585 - 3M V.A.C. Veraflo Cleanse Choice Dressing Kit, 3M Veraflo Cleanse Choice Complete Dressing Kit K221585 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3M Healthcare Business Group. Cleared Mar 2023. https://www.510kdatabase.net/k221805/ 2023-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k221805-accursound-electronic-stethoscope-as-101-fda-510k.jpg K221805 - AccurSound Electronic Stethoscope AS-101 K221805 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Heroic Faith International , Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k222096/ 2023-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k222096-endo-ultrasonic-activator-fda-510k.jpg K222096 - Endo Ultrasonic Activator K222096 is a FDA 510(k) cleared dental medical device. Manufacturer: Foshan Coxo Medical Instrument Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k222105/ 2023-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k222105-response-5560-cannulated-screw-system-fda-510k.jpg K222105 - RESPONSE 5.5/6.0 Cannulated Screw System K222105 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OrthoPediatrics Corp.. Cleared Mar 2023. https://www.510kdatabase.net/k222151/ 2023-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k222151-sterilization-wrap-fda-510k.jpg K222151 - Sterilization Wrap K222151 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Kenpax International Limited. Cleared Mar 2023. https://www.510kdatabase.net/k222332/ 2023-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k222332-memed-bv-fda-510k.jpg K222332 - MeMed BV K222332 is a FDA 510(k) cleared microbiology medical device. Manufacturer: MeMed Diagnostics, Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k222367/ 2023-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k222367-save-gbr-fda-510k.jpg K222367 - SAVE GBR K222367 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentis Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k222423/ 2023-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k222423-fixone-all-suture-anchor-fda-510k.jpg K222423 - Fixone All Suture Anchor K222423 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aju Pharm Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k222620/ 2023-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k222620-sterilized-latex-surgical-gloves-fda-510k.jpg K222620 - Sterilized Latex Surgical Gloves K222620 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Suzhou Colour-Way New Material Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k222859/ 2023-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k222859-3m-vac-peel-and-place-dressing-kit-fda-510k.jpg K222859 - 3M V.A.C. Peel and Place Dressing Kit, Small (EZ10SML), 3M V.A.C. Peel and Place Dressing Kit, Medium (EZ10MED), 3M V.A.C. Peel and Place Dressing Kit, Large (EZ10LRG) K222859 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3M. Cleared Mar 2023. https://www.510kdatabase.net/k223419/ 2023-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k223419-triever16-curve-fda-510k.jpg K223419 - Triever16 Curve K223419 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inari Medical. Cleared Mar 2023. https://www.510kdatabase.net/k223441/ 2023-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k223441-spaceflex-acetabular-cup-fda-510k.jpg K223441 - SpaceFlex Acetabular Cup K223441 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: G21, S.R.L.. Cleared Mar 2023. https://www.510kdatabase.net/k223488/ 2023-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k223488-closurefast-endovenous-radiofrequency-fda-510k.jpg K223488 - ClosureFast™ Endovenous Radiofrequency Ablation Catheter K223488 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medtronic, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k223765/ 2023-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k223765-atec-lateral-navigation-instruments-fda-510k.jpg K223765 - ATEC Lateral Navigation Instruments K223765 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k223895/ 2023-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k223895-disposable-medical-nitrile-examination-fda-510k.jpg K223895 - Disposable Medical Nitrile Examination Gloves K223895 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hebei Titans Hongsen Medical Technology Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k230482/ 2023-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k230482-swedge-pedicle-screw-fixation-system-fda-510k.jpg K230482 - Swedge™ Pedicle Screw Fixation System K230482 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinal Resources, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k213362/ 2023-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k213362-biofire-global-fever-special-pathogens-fda-510k.jpg K213362 - BioFire Global Fever Special Pathogens Panel K213362 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Biofire Defense, LLC. Cleared Mar 2023. https://www.510kdatabase.net/k220464/ 2023-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k220464-tigon-medical-gryphon-anchor-line-fda-510k.jpg K220464 - Tigon Medical Gryphon Anchor Line K220464 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tigon Medical. Cleared Mar 2023. https://www.510kdatabase.net/k221402/ 2023-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k221402-cerec-tessera-abutment-block-cerec-fda-510k.jpg K221402 - CEREC Tessera Abutment Block, CEREC Tessera Abutment System K221402 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k222036/ 2023-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k222036-mpxa-2000-fda-510k.jpg K222036 - MPXA-2000 K222036 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medipixel, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k223049/ 2023-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k223049-cardiostat-ecg-test-solution-fda-510k.jpg K223049 - CardioSTAT® ECG Test Solution K223049 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Icentia, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k223086/ 2023-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k223086-ceribell-instant-eeg-headcap-fda-510k.jpg K223086 - Ceribell Instant EEG Headcap K223086 is a FDA 510(k) cleared neurology medical device. Manufacturer: Ceribell, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k223593/ 2023-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k223593-inno-port-disposable-bladeless-trocar-fda-510k.jpg K223593 - Inno-Port Disposable Bladeless Trocar, Inno-Port Disposable Optical Trocar K223593 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Taiwan Surgical Corporation. Cleared Mar 2023. https://www.510kdatabase.net/k223824/ 2023-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k223824-polarsheath-steerable-sheath-12f-fda-510k.jpg K223824 - POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAP™ EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6310), -SMARTFREEZE™ 16 PIN Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6320), -SMARTFREEZE™ CIRCA Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6340), SMARTFREEZE™ Pressure Sensor K223824 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Mar 2023. https://www.510kdatabase.net/k223837/ 2023-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k223837-spira-c-integrated-fixation-system-fda-510k.jpg K223837 - SPIRA®-C Integrated Fixation System K223837 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Camber Spine Technologies. Cleared Mar 2023. https://www.510kdatabase.net/k223889/ 2023-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k223889-stativ-knotted-uhmwpe-suture-anchor-fda-510k.jpg K223889 - Stativ® Knotted UHMWPE Suture Anchor K223889 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Healthium Medtech Limited. Cleared Mar 2023. https://www.510kdatabase.net/k230142/ 2023-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k230142-epi-stop-nasal-gelepistaxis-pack-fda-510k.jpg K230142 - Epi-Stop Nasal Gel/epistaxis pack K230142 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Biomed Ent, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k230191/ 2023-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k230191-arise-uhp-dilatation-catheter-fda-510k.jpg K230191 - Arise™ UHP Dilatation Catheter K230191 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Creagh Medical, Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k230194/ 2023-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k230194-hf-surgery-generator-400khz-fda-510k.jpg K230194 - HF Surgery Generator 400KHZ K230194 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Richard Wolf Medical Instruments Corporation. Cleared Mar 2023. https://www.510kdatabase.net/k230533/ 2023-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k230533-motive-electrode-fda-510k.jpg K230533 - Motive™ Electrode K230533 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cymedica Orthopedics, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k230583/ 2023-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k230583-tryptik-ti-fda-510k.jpg K230583 - Tryptik Ti K230583 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spineart SA. Cleared Mar 2023. https://www.510kdatabase.net/k214070/ 2023-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k214070-ovitex-prs-long-term-resorbable-fda-510k.jpg K214070 - OviTex PRS (Long Term Resorbable) K214070 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Tela Bio. Cleared Mar 2023. https://www.510kdatabase.net/k220026/ 2023-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k220026-genomadix-cube-cyp2c19-system-fda-510k.jpg K220026 - Genomadix Cube CYP2C19 System K220026 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Genomadix, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k222617/ 2023-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k222617-easytouch-lancing-device-fda-510k.jpg K222617 - EasyTouch Lancing Device K222617 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stat Medical Devices. Cleared Mar 2023. https://www.510kdatabase.net/k222709/ 2023-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k222709-retraction-cwm-910t-apolex-tite-fda-510k.jpg K222709 - Retraction, CWM-910T, APOLEX Tite K222709 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Chungwoo Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k223490/ 2023-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k223490-flightplan-for-embolization-fda-510k.jpg K223490 - FlightPlan for Embolization K223490 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems SCS. Cleared Mar 2023. https://www.510kdatabase.net/k223672/ 2023-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k223672-instrument-case-p1340904-fda-510k.jpg K223672 - Instrument Case P1340904 K223672 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cochlear. Cleared Mar 2023. https://www.510kdatabase.net/k223708/ 2023-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k223708-entasis-3d-dual-lead-sacroiliac-fda-510k.jpg K223708 - Entasis 3D Dual-Lead Sacroiliac Implant System K223708 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corelink, LLC. Cleared Mar 2023. https://www.510kdatabase.net/k223844/ 2023-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k223844-sensititre-20-24-hour-haemophilus-fda-510k.jpg K223844 - Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Delafloxacin in the dilution range of 0.00025-8ug/ml (Streptococcus species) and 0.000125-8ug/ml (Haemophilus influenzae) K223844 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Thermo Fisher Scientific. Cleared Mar 2023. https://www.510kdatabase.net/k230054/ 2023-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k230054-dsm-biomedical-calcium-phosphate-cement-fda-510k.jpg K230054 - DSM Biomedical Calcium Phosphate Cement K230054 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Dsm Biomedical. Cleared Mar 2023. https://www.510kdatabase.net/k230471/ 2023-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k230471-linksymphoknee-fixed-bearing-fda-510k.jpg K230471 - LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface K230471 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Waldemar Link GmbH & Co. KG. Cleared Mar 2023. https://www.510kdatabase.net/k230520/ 2023-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k230520-nio-color-2mp-mdnc-2521-fda-510k.jpg K230520 - Nio Color 2MP (MDNC-2521) K230520 is a FDA 510(k) cleared radiology medical device. Manufacturer: Barco N.V.. Cleared Mar 2023. https://www.510kdatabase.net/k230561/ 2023-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k230561-syngo-carbon-space-va30a-fda-510k.jpg K230561 - Syngo Carbon Space VA30A K230561 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Healthcare GmbH. Cleared Mar 2023. https://www.510kdatabase.net/k220725/ 2023-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k220725-hpr45i-fda-510k.jpg K220725 - HPR45i K220725 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: F Care Systems USA, LLC. Cleared Mar 2023. https://www.510kdatabase.net/k221996/ 2023-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k221996-p-cure-proton-beam-therapy-system-fda-510k.jpg K221996 - P-Cure Proton Beam Therapy System K221996 is a FDA 510(k) cleared radiology medical device. Manufacturer: P-Cure, Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k222104/ 2023-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k222104-atellica-ch-diazo-total-bilirubin-dtbil-fda-510k.jpg K222104 - Atellica® CH Diazo Total Bilirubin (D_TBil) K222104 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k222417/ 2023-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k222417-shina-safety-needle-fda-510k.jpg K222417 - Shina Safety Needle K222417 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shina Corporation. Cleared Mar 2023. https://www.510kdatabase.net/k222828/ 2023-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k222828-specimen-bag-model-wep040306b-fda-510k.jpg K222828 - Specimen Bag, model: WEP040306B, WEP010304B, WEP040304B, WEP010759B, WEP010709B, WEP010304A, WEP010759A, WEP010709A K222828 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wickimed (Huizhou) Medical Equipment Manufacturing Co.,Ltd. Cleared Mar 2023. https://www.510kdatabase.net/k223043/ 2023-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k223043-the-integrity-spine-core-system-fda-510k.jpg K223043 - The Integrity Spine Core System K223043 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Integrity Spine. Cleared Mar 2023. https://www.510kdatabase.net/k223245/ 2023-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k223245-colibr-fda-510k.jpg K223245 - Colibrí K223245 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Copan Wasp Srl. Cleared Mar 2023. https://www.510kdatabase.net/k223875/ 2023-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k223875-mobineuro-alita-intraoperative-mri-fda-510k.jpg K223875 - MOBINEURO Alita Intraoperative MRI System K223875 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sino Canada Health Engineering Research Institute (Hefei). Cleared Mar 2023. https://www.510kdatabase.net/k230163/ 2023-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k230163-tens-and-ems-stimulation-otc-fda-510k.jpg K230163 - TENS and EMS Stimulation (OTC) K230163 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Changsha Yuwen Medical Equipment Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k230174/ 2023-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k230174-tens-and-ems-stimulation-otc-fda-510k.jpg K230174 - TENS and EMS Stimulation (OTC) K230174 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Changsha Yuwen Medical Equipment Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k221808/ 2023-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k221808-inteross-collagen-fda-510k.jpg K221808 - InterOss Collagen K221808 is a FDA 510(k) cleared dental medical device. Manufacturer: Sigmagraft, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k221841/ 2023-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k221841-eolife-fda-510k.jpg K221841 - EOlife® K221841 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Archeon. Cleared Mar 2023. https://www.510kdatabase.net/k220963/ 2023-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k220963-simplexa-covid-19-flu-ab-direct-fda-510k.jpg K220963 - Simplexa COVID-19 & Flu A/B Direct K220963 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Diasorin Molecular, LLC. Cleared Mar 2023. https://www.510kdatabase.net/k221119/ 2023-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k221119-rcrp-flex-reagent-cartridge-fda-510k.jpg K221119 - RCRP Flex reagent cartridge K221119 is a FDA 510(k) cleared immunology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k221544/ 2023-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k221544-magventure-tms-atlas-neuro-navigation-fda-510k.jpg K221544 - MagVenture TMS Atlas Neuro Navigation System K221544 is a FDA 510(k) cleared neurology medical device. Manufacturer: Tonica Elektronik A/S. Cleared Mar 2023. https://www.510kdatabase.net/k221758/ 2023-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k221758-smr-stemless-anatomic-fda-510k.jpg K221758 - SMR Stemless Anatomic K221758 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Lima Corporate S.P.A.. Cleared Mar 2023. https://www.510kdatabase.net/k221772/ 2023-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k221772-neurorpm-fda-510k.jpg K221772 - NeuroRPM K221772 is a FDA 510(k) cleared neurology medical device. Manufacturer: New Touch Digital, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k221782/ 2023-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k221782-meritrans-eco-reusable-pressure-fda-510k.jpg K221782 - Meritrans ECO Reusable Pressure Transducer, Meritrans ECO Domes K221782 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Pte. , Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k221893/ 2023-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k221893-karl-storz-bipolar-resectoscopes-with-fda-510k.jpg K221893 - KARL STORZ Bipolar Resectoscopes with HF Cable K221893 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k221965/ 2023-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k221965-femdx-falloview-fda-510k.jpg K221965 - FemDx FalloView K221965 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Femdx Medsystems, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k222101/ 2023-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k222101-prism-fda-510k.jpg K222101 - Prism K222101 is a FDA 510(k) cleared neurology medical device. Manufacturer: Graymatters Health , Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k223073/ 2023-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k223073-alio-fda-510k.jpg K223073 - Alio K223073 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Alio, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k223162/ 2023-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k223162-healgen-accurate-oral-fluid-drug-test-fda-510k.jpg K223162 - Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COT K223162 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Healgen Scientific, LLC. Cleared Mar 2023. https://www.510kdatabase.net/k223418/ 2023-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k223418-degen-impulse-am-system-fda-510k.jpg K223418 - DeGen Impulse AM™ System K223418 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Degen Medical. Cleared Mar 2023. https://www.510kdatabase.net/k223443/ 2023-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k223443-viz-aaa-fda-510k.jpg K223443 - Viz AAA K223443 is a FDA 510(k) cleared radiology medical device. Manufacturer: Viz. Ai, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k223613/ 2023-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k223613-inthrill-thrombectomy-system-fda-510k.jpg K223613 - InThrill Thrombectomy System K223613 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inari Medical, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k223666/ 2023-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k223666-ablacath-mapping-catheter-fda-510k.jpg K223666 - Ablacath™ Mapping Catheter K223666 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ablacon, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k223878/ 2023-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k223878-aevumed-rapid-suture-anchors-fda-510k.jpg K223878 - Aevumed RAPID Suture Anchors K223878 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aevumed, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k230115/ 2023-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k230115-denture-base-resin-fda-510k.jpg K230115 - Denture Base Resin K230115 is a FDA 510(k) cleared dental medical device. Manufacturer: Aidite (Qinhuangdao) Technology Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k230141/ 2023-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k230141-loqteq-va-elbow-plates-2735-system-fda-510k.jpg K230141 - LOQTEQ® VA Elbow Plates 2.7/3.5 System K230141 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aap Implantate AG. Cleared Mar 2023. https://www.510kdatabase.net/k230435/ 2023-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k230435-arthrex-39-mm-swivelock-anchor-fda-510k.jpg K230435 - Arthrex 3.9 mm SwiveLock Anchor K230435 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k230441/ 2023-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k230441-empowr-stem-extender-50mm-fda-510k.jpg K230441 - EMPOWR Stem Extender, 50mm K230441 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Encore Medical, L.P Dba Enovis. Cleared Mar 2023. https://www.510kdatabase.net/k220673/ 2023-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k220673-sterile-silver-alginate-wound-dressing-fda-510k.jpg K220673 - Sterile Silver Alginate Wound Dressing K220673 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Qingdao Bright Moon Biomedical Materials Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k222619/ 2023-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k222619-ensmile-fda-510k.jpg K222619 - Ensmile K222619 is a FDA 510(k) cleared dental medical device. Manufacturer: Ensmile Pvt, Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k222813/ 2023-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k222813-nitrile-examination-gloves-fda-510k.jpg K222813 - Nitrile Examination Gloves K222813 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ecoglove Medical Manufacturing Company Limited. Cleared Mar 2023. https://www.510kdatabase.net/k222838/ 2023-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k222838-isyncbrain-c-fda-510k.jpg K222838 - iSyncBrain©-C K222838 is a FDA 510(k) cleared neurology medical device. Manufacturer: iMediSync, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k222839/ 2023-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k222839-endowrist-stapler-30-system-endowrist-fda-510k.jpg K222839 - EndoWrist Stapler 30 System, EndoWrist Stapler 45 System, SureForm 45 System, SureForm 60 System, 8 mm SureForm 30 System K222839 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k223084/ 2023-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k223084-milkmate-breast-pump-fda-510k.jpg K223084 - MilkMate Breast Pump K223084 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Milkmate Products, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k223095/ 2023-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k223095-senhance-surgical-system-fda-510k.jpg K223095 - Senhance Surgical System K223095 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Asensus Surgical, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k223154/ 2023-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k223154-magstim-horizon-30-tms-therapy-system-fda-510k.jpg K223154 - Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+ K223154 is a FDA 510(k) cleared neurology medical device. Manufacturer: Magstim Company, Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k223393/ 2023-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k223393-electric-wheelchair-fda-510k.jpg K223393 - Electric Wheelchair K223393 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Shanghai Bangbang Robotics Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k223828/ 2023-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k223828-bencox-delta-option-heads-fda-510k.jpg K223828 - BENCOX Delta Option Heads K223828 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corentec Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k230404/ 2023-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k230404-biofire-filmarray-gastrointestinal-gi-fda-510k.jpg K230404 - BIOFIRE FILMARRAY Gastrointestinal (GI) Panel K230404 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Biofire Diagnostics, LLC. Cleared Mar 2023. https://www.510kdatabase.net/k214001/ 2023-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k214001-comprehensive-shoulder-system-fda-510k.jpg K214001 - Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System K214001 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet Manufacturing Corp. Cleared Mar 2023. https://www.510kdatabase.net/k220122/ 2023-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k220122-apex-6-fda-510k.jpg K220122 - APEX 6 K220122 is a FDA 510(k) cleared neurology medical device. Manufacturer: Rf Innovations, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k220234/ 2023-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k220234-precice-intramedullary-limb-fda-510k.jpg K220234 - Precice Intramedullary Limb Lengthening System K220234 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nuvasive Specialized Orthopedics, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k221924/ 2023-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k221924-digital-routines-fda-510k.jpg K221924 - Digital Routines K221924 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Gnc Holdings, LLC. Cleared Mar 2023. https://www.510kdatabase.net/k222983/ 2023-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k222983-neuroblate-fusion-s-software-v317-fda-510k.jpg K222983 - NeuroBlate Fusion-S Software V3.17 K222983 is a FDA 510(k) cleared neurology medical device. Manufacturer: Monteris Medical,. Cleared Mar 2023. https://www.510kdatabase.net/k222991/ 2023-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k222991-air-compression-leg-massager-model-emk-fda-510k.jpg K222991 - Air Compression Leg Massager (model: EMK-701) K222991 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Xiamen Emoka Health Science & Technology Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k223102/ 2023-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k223102-tegamen-nitrile-examination-gloves-fda-510k.jpg K223102 - Tegamen Nitrile Examination Gloves K223102 is a FDA 510(k) cleared general hospital medical device. Manufacturer: M/S Tegamen Safety Products Private Limited. Cleared Mar 2023. https://www.510kdatabase.net/k223375/ 2023-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k223375-powder-free-nitrile-patient-fda-510k.jpg K223375 - Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate. K223375 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Kossan International Sdn Bhd3. Cleared Mar 2023. https://www.510kdatabase.net/k223381/ 2023-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k223381-iexaminer-system-with-panoptic-plus-fda-510k.jpg K223381 - iExaminer System with Panoptic Plus K223381 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Welch Allyn, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k223760/ 2023-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k223760-echelon-linear-60-mm-cutter-glc60-fda-510k.jpg K223760 - ECHELON LINEAR™ 60 mm Cutter (GLC60) K223760 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon Endo-Surgery. Cleared Mar 2023. https://www.510kdatabase.net/k230124/ 2023-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k230124-lustre-clearskin-renew-pro-facewear-fda-510k.jpg K230124 - LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001) K230124 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Light Tree Ventures Europe B.V.. Cleared Mar 2023. https://www.510kdatabase.net/k212906/ 2023-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k212906-heartbuds-electronic-stethoscope-fda-510k.jpg K212906 - HeartBuds Electronic Stethoscope K212906 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Heartbuds, LLC. Cleared Mar 2023. https://www.510kdatabase.net/k213247/ 2023-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k213247-jett-plasma-medical-ii-fda-510k.jpg K213247 - JETT PLASMA Medical II K213247 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Compex, Spol, S.R.O.. Cleared Mar 2023. https://www.510kdatabase.net/k223137/ 2023-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k223137-lexie-lumen-self-fitting-otc-hearing-fda-510k.jpg K223137 - Lexie Lumen Self-Fitting OTC Hearing Aids with Lexie Application K223137 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Hearx SA (Pty) , Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k223279/ 2023-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k223279-rt-elements-40-fda-510k.jpg K223279 - RT Elements (4.0) K223279 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab AG. Cleared Mar 2023. https://www.510kdatabase.net/k223464/ 2023-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k223464-leg-and-foot-air-wave-pressure-therapy-fda-510k.jpg K223464 - Leg and Foot Air Wave Pressure Therapy Device K223464 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zhangzhou Easepal Innovation CO , Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k223609/ 2023-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k223609-revcore-thrombectomy-catheter-fda-510k.jpg K223609 - RevCore™ Thrombectomy Catheter. K223609 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inari Medical, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k223753/ 2023-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k223753-cervical-plate-system-fda-510k.jpg K223753 - Cervical Plate System K223753 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Double Medical Technology, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k230019/ 2023-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k230019-sofwave-system-fda-510k.jpg K230019 - SofWave System K230019 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sofwave Medical, Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k230145/ 2023-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k230145-one-cuf-fda-510k.jpg K230145 - ONE-CUF K230145 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k221352/ 2023-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k221352-surgical-face-mask-fda-510k.jpg K221352 - Surgical Face Mask K221352 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wuhan Huashida Protective Products Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k222775/ 2023-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k222775-aarhus-applicator-set-fda-510k.jpg K222775 - Aarhus Applicator Set K222775 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k222954/ 2023-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k222954-innova-vision-hydrogel-etafilcon-a-fda-510k.jpg K222954 - Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens K222954 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Innova Vision, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k223321/ 2023-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k223321-omnia-medical-coupler-c-anterior-fda-510k.jpg K223321 - Omnia Medical Coupler-C Anterior Cervical Plate K223321 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Omnia Medical, LLC. Cleared Mar 2023. https://www.510kdatabase.net/k223350/ 2023-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k223350-remi-robotic-navigation-system-fda-510k.jpg K223350 - Remi Robotic Navigation System K223350 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Fusion Robotics, LLC. Cleared Mar 2023. https://www.510kdatabase.net/k222456/ 2023-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k222456-high-protection-surgical-gown-fda-510k.jpg K222456 - High Protection Surgical Gown K222456 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3A Medical Products Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k213744/ 2023-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k213744-avoset-infusion-pump-system-fda-510k.jpg K213744 - Avoset Infusion Pump System K213744 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Eitan Medical , Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k220398/ 2023-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k220398-aristotle-14-guidewire-fda-510k.jpg K220398 - Aristotle 14 Guidewire K220398 is a FDA 510(k) cleared neurology medical device. Manufacturer: Scientia Vascular, LLC. Cleared Mar 2023. https://www.510kdatabase.net/k221129/ 2023-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k221129-cloudtms-for-ocd-fda-510k.jpg K221129 - CloudTMS for OCD K221129 is a FDA 510(k) cleared neurology medical device. Manufacturer: Teleemg, LLC. Cleared Mar 2023. https://www.510kdatabase.net/k221198/ 2023-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k221198-sensititre-yeastone-susceptibility-fda-510k.jpg K221198 - Sensititre YeastOne Susceptibility System with Fluconazole in the dilution range of 0.12-128ug/mL K221198 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Thermo Fisher Scientific. Cleared Mar 2023. https://www.510kdatabase.net/k221292/ 2023-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k221292-uni-knee-resurfacing-system-fda-510k.jpg K221292 - Uni Knee Resurfacing System K221292 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Overture Resurfacing, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k221623/ 2023-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k221623-flexsys-flexsys-uvb-epl-308-nm-flexsys-fda-510k.jpg K221623 - FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm K221623 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Gme (German Medical Engineering) GmbH. Cleared Mar 2023. https://www.510kdatabase.net/k222478/ 2023-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k222478-bd-vacutainer-luer-lok-access-device-fda-510k.jpg K222478 - BD Vacutainer® Luer-Lok™ Access Device, BD Vacutainer® Blood Transfer Device K222478 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson and Company. Cleared Mar 2023. https://www.510kdatabase.net/k222718/ 2023-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k222718-vial-adapter-fda-510k.jpg K222718 - Vial Adapter K222718 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hangzhou Qiantang Longyue Biotechnology Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k223175/ 2023-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k223175-lntravascular-administration-sets-with-fda-510k.jpg K223175 - lntravascular Administration Sets with Stopcock and Manifold K223175 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corporation. Cleared Mar 2023. https://www.510kdatabase.net/k223325/ 2023-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k223325-umi-panorama-fda-510k.jpg K223325 - uMI Panorama K223325 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k230295/ 2023-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k230295-attune-revision-cones-fda-510k.jpg K230295 - ATTUNE® Revision Cones K230295 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Ireland UC. Cleared Mar 2023. https://www.510kdatabase.net/k230349/ 2023-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k230349-lyra-rsvhmpv-assay-fda-510k.jpg K230349 - Lyra RSV+hMPV Assay K230349 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Quidel Corporation. Cleared Mar 2023. https://www.510kdatabase.net/k230433/ 2023-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k230433-arthrex-knotless-fibertak-suture-anchor-fda-510k.jpg K230433 - Arthrex Knotless FiberTak Suture Anchor K230433 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k221301/ 2023-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k221301-dess-dental-smart-solutions-fda-510k.jpg K221301 - DESS Dental Smart Solutions K221301 is a FDA 510(k) cleared dental medical device. Manufacturer: Terrats Medical SL. Cleared Mar 2023. https://www.510kdatabase.net/k221373/ 2023-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k221373-essenz-hlm-fda-510k.jpg K221373 - Essenz HLM K221373 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Livanova Deutschland, GmbH. Cleared Mar 2023. https://www.510kdatabase.net/k221700/ 2023-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k221700-autopulse-nxt-resuscitation-system-fda-510k.jpg K221700 - AutoPulse NXT Resuscitation System K221700 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Zoll Circulation, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k221706/ 2023-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k221706-accucontour-fda-510k.jpg K221706 - AccuContour K221706 is a FDA 510(k) cleared radiology medical device. Manufacturer: Manteia Technologies Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k221816/ 2023-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k221816-wesper-lab-fda-510k.jpg K221816 - Wesper Lab K221816 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Wesper, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k221919/ 2023-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k221919-doubleflo-inflowoutflow-pump-fda-510k.jpg K221919 - DOUBLEFLO INFLOW/OUTFLOW PUMP, accessories and tubing sets K221919 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Hemodia Sas. Cleared Mar 2023. https://www.510kdatabase.net/k221930/ 2023-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k221930-cereglide-71-intermediate-catheter-fda-510k.jpg K221930 - CEREGLIDE 71 Intermediate Catheter K221930 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cerenovus, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k221934/ 2023-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k221934-cereglide-71-intermediate-catheter-fda-510k.jpg K221934 - CEREGLIDE 71 Intermediate Catheter K221934 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cerenovus, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k222430/ 2023-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k222430-vitek-2-ast-gram-negative-fosfomycin-4-fda-510k.jpg K222430 - VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin K222430 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Biomerieux Sa, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k222663/ 2023-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k222663-multistage-balloon-dilatation-catheter-fda-510k.jpg K222663 - MultiStage Balloon Dilatation Catheter K222663 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Dongguan TT Medical, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k222875/ 2023-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k222875-powered-muscle-stimulator-model-fda-510k.jpg K222875 - Powered Muscle Stimulator (Model name:MagGraver F200) K222875 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Nanjing Vishee Medical Technology Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k223432/ 2023-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k223432-vassallo-gt-018-hybrid-fda-510k.jpg K223432 - Vassallo GT 018 Hybrid K223432 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Filmecc Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k223514/ 2023-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k223514-spectral-bone-marrow-fda-510k.jpg K223514 - Spectral Bone Marrow K223514 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems, LLC. Cleared Mar 2023. https://www.510kdatabase.net/k223642/ 2023-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k223642-led-lip-perfector-model-zc-05-fda-510k.jpg K223642 - LED Lip Perfector, model: ZC-05 K223642 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Light Tree Ventures Europe B.V.. Cleared Mar 2023. https://www.510kdatabase.net/k223693/ 2023-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k223693-electric-breast-pump-model-m5-fda-510k.jpg K223693 - Electric breast pump (model: M5) K223693 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shenzhen Lutejiacheng Technology Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k223790/ 2023-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k223790-huvex-interspinous-fusion-system-fda-510k.jpg K223790 - Huvex Interspinous Fusion System K223790 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Dio Medical Corp.. Cleared Mar 2023. https://www.510kdatabase.net/k230363/ 2023-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k230363-cps-locator-3d-delivery-catheter-fda-510k.jpg K230363 - CPS Locator 3D Delivery Catheter K230363 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: CenterPoint Systems, LLC. Cleared Mar 2023. https://www.510kdatabase.net/k213906/ 2023-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k213906-extricare-1000-negative-pressure-wound-fda-510k.jpg K213906 - extriCARE 1000 Negative Pressure Wound Therapy System K213906 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Alleva Medical, Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k220101/ 2023-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k220101-pulse-oximeter-fda-510k.jpg K220101 - Pulse Oximeter K220101 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Beijing Choice Electronic Technology Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k220613/ 2023-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k220613-bausch-lomb-kalifilcon-a-soft-fda-510k.jpg K220613 - Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia K220613 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Bausch & Lomb, Incorporated. Cleared Mar 2023. https://www.510kdatabase.net/k220966/ 2023-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k220966-sinefix-fda-510k.jpg K220966 - SINEFIX K220966 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: BAAT Medical Products B.V.. Cleared Mar 2023. https://www.510kdatabase.net/k221209/ 2023-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k221209-precision-eco-compostable-plant-based-fda-510k.jpg K221209 - PRECISION ECO Compostable / Plant Based Procedural Mask with Earloops K221209 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Padm Medical, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k222007/ 2023-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k222007-arthrex-virtual-implant-positioning-fda-510k.jpg K222007 - Arthrex Virtual Implant Positioning (VIP) System K222007 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k222098/ 2023-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k222098-manasport-fda-510k.jpg K222098 - ManaSport+ K222098 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Manamed, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k222136/ 2023-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k222136-cryo-thermo-compression-device-fgk002-fda-510k.jpg K222136 - Cryo-Thermo Compression Device (FGK002) K222136 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Suzhou Microport Rehabtech (Group) Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k222355/ 2023-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k222355-pathkeeper-system-fda-510k.jpg K222355 - PathKeeper System K222355 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Pathkeeper Surgical , Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k223681/ 2023-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k223681-respiree-cardio-respiratory-monitor-fda-510k.jpg K223681 - Respiree Cardio-Respiratory Monitor K223681 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respiree Pte, Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k223688/ 2023-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k223688-conduit-lateral-lumbar-intervertebral-fda-510k.jpg K223688 - CONDUIT™ Lateral Lumbar Intervertebral Fusion Cage, CONDUIT™ Instruments K223688 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International S?rl. Cleared Mar 2023. https://www.510kdatabase.net/k223742/ 2023-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k223742-dental-ceramic-blocks-fda-510k.jpg K223742 - Dental Ceramic Blocks K223742 is a FDA 510(k) cleared dental medical device. Manufacturer: Aidite (Qinhuangdao) Technology Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k230076/ 2023-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k230076-enhanced-aurora-medical-diode-system-fda-510k.jpg K230076 - Enhanced AURORA™ Medical Diode System, and related accessories K230076 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Psoria-Shield, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k230321/ 2023-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k230321-persona-personalized-knee-system-fda-510k.jpg K230321 - Persona™ Personalized Knee System K230321 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/den220039/ 2023-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/den220039-sofia-2-sars-antigen-fia-sofia-2-sars-fda-510k.jpg DEN220039 - Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set DEN220039 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Quidel Corporation. Cleared Mar 2023. https://www.510kdatabase.net/k213892/ 2023-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k213892-grosz-warming-liquid-grosz-play-fda-510k.jpg K213892 - Grosz Warming Liquid, Grosz Play Tingling, Grosz KY Yours & Mine K213892 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Rb Health (Us), LLC. Cleared Mar 2023. https://www.510kdatabase.net/k220407/ 2023-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k220407-visby-medical-sexual-health-test-fda-510k.jpg K220407 - Visby Medical Sexual Health Test K220407 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Visby Medical. Cleared Mar 2023. https://www.510kdatabase.net/k220549/ 2023-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k220549-mint-product-family-including-mint-fda-510k.jpg K220549 - MINT Product Family (Including MINT, MINT Lift, and MINT-I Sutures), MINT Lift ML 1043, MINT Lift ML 1013, MINT Lift 1019, MINT Lift Mini 1014 K220549 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Hans Biomed Corporation. Cleared Mar 2023. https://www.510kdatabase.net/k221883/ 2023-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k221883-solero-microwave-tissue-ablation-mta-fda-510k.jpg K221883 - Solero Microwave Tissue Ablation (MTA) System and Accessories K221883 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: AngioDynamics, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k222465/ 2023-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k222465-tyber-medical-anatomical-plating-system-fda-510k.jpg K222465 - Tyber Medical Anatomical Plating System K222465 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tyber Medical, LLC. Cleared Mar 2023. https://www.510kdatabase.net/k222897/ 2023-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k222897-enlight-2100-fda-510k.jpg K222897 - Enlight 2100 K222897 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Timpel S.A.. Cleared Mar 2023. https://www.510kdatabase.net/k223024/ 2023-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k223024-medcad-accuplan-system-fda-510k.jpg K223024 - MedCAD AccuPlan System K223024 is a FDA 510(k) cleared dental medical device. Manufacturer: Medcad. Cleared Mar 2023. https://www.510kdatabase.net/k223401/ 2023-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k223401-disposable-surgical-gowns-smlxlxxlxxxl-fda-510k.jpg K223401 - Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL) K223401 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Xiamen Probtain Medical Techology Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k223726/ 2023-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k223726-aquilion-precision-tsx-304a4-v1014-fda-510k.jpg K223726 - Aquilion Precision (TSX-304A/4) V10.14 with AiCE K223726 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Mar 2023. https://www.510kdatabase.net/k230301/ 2023-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k230301-athena-iii-cervical-plate-system-fda-510k.jpg K230301 - Athena III Cervical Plate System K230301 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medyssey USA, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k230331/ 2023-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k230331-protrieve-sheath-fda-510k.jpg K230331 - Protrieve Sheath K230331 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inari Medical, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k212161/ 2023-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k212161-radical-7-pulse-co-oximeter-and-fda-510k.jpg K212161 - Radical-7 Pulse CO-Oximeter and Accessories, Rad-97 and Accessories K212161 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Masimo Corporation. Cleared Mar 2023. https://www.510kdatabase.net/k221158/ 2023-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k221158-single-use-video-flexible-fda-510k.jpg K221158 - Single-Use Video Flexible Ureterorenoscope System K221158 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Guangzhou Red Pine Medical Instrument Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k221621/ 2023-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k221621-pro-x1-trochanteric-nailing-system-fda-510k.jpg K221621 - Pro-X1™ Trochanteric Nailing System K221621 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: X-Bolt Orthopedics. Cleared Mar 2023. https://www.510kdatabase.net/k222445/ 2023-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k222445-lc-chromeflow-fda-510k.jpg K222445 - LC ChromeFlow K222445 is a FDA 510(k) cleared dental medical device. Manufacturer: S&C Polymer Silicon- Und Composite Spezialitaten GmbH. Cleared Mar 2023. https://www.510kdatabase.net/k222457/ 2023-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k222457-provata-implant-system-fda-510k.jpg K222457 - Provata Implant System K222457 is a FDA 510(k) cleared dental medical device. Manufacturer: Southern Implants (Pty), Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k222672/ 2023-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k222672-disposable-insulin-syringe-fda-510k.jpg K222672 - Disposable Insulin Syringe K222672 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hantech Medical Device Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k223232/ 2023-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k223232-procedure-masksurgical-maskface-mask-fda-510k.jpg K223232 - Procedure mask/Surgical mask/Face mask K223232 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Winner Medical Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k223653/ 2023-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k223653-bd-vaginal-panel-fda-510k.jpg K223653 - BD Vaginal Panel K223653 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson and Company. Cleared Mar 2023. https://www.510kdatabase.net/k223930/ 2023-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k223930-a1417mcwa1717mcwf1417mcw-fda-510k.jpg K223930 - A1417MCW/A1717MCW/F1417MCW K223930 is a FDA 510(k) cleared radiology medical device. Manufacturer: H&abyz Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k230315/ 2023-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k230315-materialise-shoulder-system-fda-510k.jpg K230315 - Materialise Shoulder System™ Materialise Shoulder Guide and Models SurgiCase Shoulder Planner K230315 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Materialise NV. Cleared Mar 2023. https://www.510kdatabase.net/k230383/ 2023-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k230383-savvy-surgical-mask-level-3-fda-510k.jpg K230383 - Savvy Surgical Mask - Level 3 K230383 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Alg Health, LLC. Cleared Mar 2023. https://www.510kdatabase.net/den210033/ 2023-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/den210033-lenire-tinnitus-treatment-device-fda-510k.jpg DEN210033 - Lenire Tinnitus Treatment Device DEN210033 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Neuromod Devices Limited. Cleared Mar 2023. https://www.510kdatabase.net/k223452/ 2023-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k223452-nitronox-scavenger-plus-fda-510k.jpg K223452 - Nitronox Scavenger Plus K223452 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Parker Hannifin Corporation. Cleared Mar 2023. https://www.510kdatabase.net/k212696/ 2023-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k212696-aspira-pleural-drainage-system-fda-510k.jpg K212696 - Aspira Pleural Drainage System K212696 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k221084/ 2023-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k221084-dyna-locking-trochanteric-nail-fda-510k.jpg K221084 - Dyna Locking Trochanteric Nail™ K221084 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Innosys. Cleared Mar 2023. https://www.510kdatabase.net/k221587/ 2023-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k221587-dhx-70h-xtg-70h-fda-510k.jpg K221587 - DHX-70H, XTG-70H K221587 is a FDA 510(k) cleared radiology medical device. Manufacturer: Digimed Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k221652/ 2023-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k221652-nikkicart-fda-510k.jpg K221652 - NIKKICART K221652 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Renal Care Dialysis Solutions, S.A. DE C.V.. Cleared Mar 2023. https://www.510kdatabase.net/k221661/ 2023-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k221661-abdominal-aortic-and-junctional-fda-510k.jpg K221661 - Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S) K221661 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Compression Works, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k221697/ 2023-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k221697-injection-pin-kip02031-02061-03031-03061-fda-510k.jpg K221697 - INJECTION PIN (KIP(02031-02061) (03031-03061)) K221697 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Slk Ortho, LLC. Cleared Mar 2023. https://www.510kdatabase.net/k221713/ 2023-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k221713-polypectomy-snare-fda-510k.jpg K221713 - Polypectomy Snare K221713 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hangzhou AGS MedTech Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k222379/ 2023-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k222379-alinity-m-sti-assay-fda-510k.jpg K222379 - Alinity m STI Assay K222379 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Molecular, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k222394/ 2023-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k222394-electronic-sphygmomanometers-fda-510k.jpg K222394 - Electronic Sphygmomanometers K222394 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Qingdao Yasee Medical Device Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k222447/ 2023-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k222447-freestyle-libre-2-flash-glucose-fda-510k.jpg K222447 - FreeStyle Libre 2 Flash Glucose Monitoring System K222447 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Diabetes Care, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k222573/ 2023-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k222573-imani-i2plus-breast-pump-fda-510k.jpg K222573 - imani i2Plus Breast Pump K222573 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Imani Co.. Cleared Mar 2023. https://www.510kdatabase.net/k222819/ 2023-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k222819-aquilion-serve-tsx-307a1-v12-with-aice-i-fda-510k.jpg K222819 - Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i K222819 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Mar 2023. https://www.510kdatabase.net/k222880/ 2023-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k222880-endolumik-fluorescence-guided-gastric-fda-510k.jpg K222880 - Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie) K222880 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Endolumik, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k223589/ 2023-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k223589-grappler-suture-anchor-r3flex-iol-system-fda-510k.jpg K223589 - Grappler Suture Anchor R3FLEX IOL System K223589 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paragon 28, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k223776/ 2023-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k223776-peek-spinal-infusion-cage-fda-510k.jpg K223776 - PEEK Spinal Infusion Cage K223776 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k230009/ 2023-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k230009-ez-bond-universal-fda-510k.jpg K230009 - EZ Bond Universal K230009 is a FDA 510(k) cleared dental medical device. Manufacturer: Meta Biomed Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k230060/ 2023-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k230060-light-based-hair-removal-device-gp592-fda-510k.jpg K230060 - Light Based Hair Removal Device GP592 K230060 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Gsd Tech Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k230236/ 2023-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k230236-lyra-influenza-ab-assay-fda-510k.jpg K230236 - Lyra Influenza A+B Assay K230236 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Quidel Corporation. Cleared Mar 2023. https://www.510kdatabase.net/k230256/ 2023-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k230256-rebellion-phantom-multi-bite-kerrison-fda-510k.jpg K230256 - Rebellion, Phantom Multi-Bite Kerrison Rongeur K230256 is a FDA 510(k) cleared neurology medical device. Manufacturer: Morpheus AG. Cleared Mar 2023. https://www.510kdatabase.net/k230294/ 2023-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k230294-coverscan-coverscan-v11-fda-510k.jpg K230294 - CoverScan (CoverScan v1.1) K230294 is a FDA 510(k) cleared radiology medical device. Manufacturer: Perspectum. Cleared Mar 2023. https://www.510kdatabase.net/k221340/ 2023-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k221340-inod-ultrasound-guided-biopsy-needle-fda-510k.jpg K221340 - iNod Ultrasound Guided Biopsy Needle (UPN: M00502060), iNod Ultrasound Guidance Console (UPN: M00503210) K221340 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Boston Scientific Corporation. Cleared Mar 2023. https://www.510kdatabase.net/k221696/ 2023-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k221696-rewalk-p60-fda-510k.jpg K221696 - ReWalk P6.0 K221696 is a FDA 510(k) cleared neurology medical device. Manufacturer: Re Walk Robotics , Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k222176/ 2023-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k222176-boneview-fda-510k.jpg K222176 - BoneView K222176 is a FDA 510(k) cleared radiology medical device. Manufacturer: Gleamer. Cleared Mar 2023. https://www.510kdatabase.net/k222603/ 2023-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k222603-6f-wallaby-long-sheath-fda-510k.jpg K222603 - 6F Wallaby Long Sheath K222603 is a FDA 510(k) cleared neurology medical device. Manufacturer: Wallaby Medical, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k222884/ 2023-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k222884-rapid-ncct-stroke-fda-510k.jpg K222884 - Rapid NCCT Stroke K222884 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ischemaview, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k223203/ 2023-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k223203-15t-24e-posterior-array-fda-510k.jpg K223203 - 1.5T 24E Posterior Array K223203 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen RF Tech Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k223352/ 2023-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k223352-tenderfoot-fda-510k.jpg K223352 - Tenderfoot K223352 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Accriva Diagnostics, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k223436/ 2023-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k223436-artix-ax-fda-510k.jpg K223436 - Artix AX K223436 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inari Medical. Cleared Mar 2023. https://www.510kdatabase.net/k223440/ 2023-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k223440-plasma-pen-plasma-md-fda-510k.jpg K223440 - Plasma Pen (Plasma MD) K223440 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Plasma Concepts. Cleared Mar 2023. https://www.510kdatabase.net/k223453/ 2023-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k223453-insulin-syringe-fda-510k.jpg K223453 - Insulin Syringe K223453 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Promisemed Hangzhou Meditech Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k223602/ 2023-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k223602-traumatic-brain-injury-tbi-test-fda-510k.jpg K223602 - Traumatic brain injury (TBI) test K223602 is a FDA 510(k) cleared immunology medical device. Manufacturer: Abbott Laboratories. Cleared Mar 2023. https://www.510kdatabase.net/k223628/ 2023-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k223628-neba-compact-eeg2r-mobile-headset-fda-510k.jpg K223628 - NEBA® Compact EEG2R Mobile Headset K223628 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neba Health, LLC. Cleared Mar 2023. https://www.510kdatabase.net/k223902/ 2023-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k223902-fibroscan-device-models-502-touch-530-fda-510k.jpg K223902 - FibroScan® device (Models: 502 Touch, 530 Compact, 430 Mini+, 230, and 630) K223902 is a FDA 510(k) cleared radiology medical device. Manufacturer: Echosens. Cleared Mar 2023. https://www.510kdatabase.net/k230093/ 2023-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k230093-disposable-4-layers-surgical-face-mask-fda-510k.jpg K230093 - Disposable 4 Layers Surgical Face Mask K230093 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Social Medical Supply, LLC. Cleared Mar 2023. https://www.510kdatabase.net/k230253/ 2023-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k230253-optrell-mapping-catheter-with-trueref-fda-510k.jpg K230253 - OPTRELL™ Mapping Catheter with TRUEref™ Technology K230253 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biosense Webster, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k230303/ 2023-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k230303-accuffrangio-plus-fda-510k.jpg K230303 - AccuFFRangio Plus K230303 is a FDA 510(k) cleared radiology medical device. Manufacturer: ArteryFlow Technology Co., Ltd.. Cleared Mar 2023. https://www.510kdatabase.net/k213898/ 2023-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k213898-protrack-pigtail-wire-fda-510k.jpg K213898 - ProTrack Pigtail Wire K213898 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baylis Medical Company, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k220014/ 2023-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k220014-rshock-fda-510k.jpg K220014 - RSHOCK K220014 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Swims America Corp. Cleared Mar 2023. https://www.510kdatabase.net/k221053/ 2023-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k221053-magnes-c-anterior-cervical-plate-system-fda-510k.jpg K221053 - Magnes-C Anterior Cervical Plate System K221053 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Fellowship of Orthopaedic Researchers, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k221680/ 2023-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k221680-xeleris-v-processing-and-review-system-fda-510k.jpg K221680 - Xeleris V Processing and Review System K221680 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Mar 2023. https://www.510kdatabase.net/k222187/ 2023-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k222187-multistage-balloon-dilatation-catheter-fda-510k.jpg K222187 - Multistage Balloon Dilatation Catheter K222187 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Dongguan TT Medical, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k222280/ 2023-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k222280-bigfoot-unity-diabetes-management-system-fda-510k.jpg K222280 - Bigfoot Unity® Diabetes Management System K222280 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bigfoot Biomedical, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k222975/ 2023-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k222975-advantis-platform-fda-510k.jpg K222975 - Advantis Platform K222975 is a FDA 510(k) cleared radiology medical device. Manufacturer: Advantis Medical Imaging Single Member P.C.. Cleared Mar 2023. https://www.510kdatabase.net/k223040/ 2023-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k223040-endo-smartcap-fda-510k.jpg K223040 - Endo SmartCap K223040 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medivators, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k223144/ 2023-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k223144-galaxy-system-fda-510k.jpg K223144 - Galaxy System K223144 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Noah Medical Corp.. Cleared Mar 2023. https://www.510kdatabase.net/k223423/ 2023-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k223423-32hq713d-fda-510k.jpg K223423 - 32HQ713D K223423 is a FDA 510(k) cleared radiology medical device. Manufacturer: Lg Electronics.Inc. Cleared Mar 2023. https://www.510kdatabase.net/k230283/ 2023-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k230283-peel-away-introducer-405104-405108-fda-510k.jpg K230283 - Peel-Away Introducer (405104, 405108, 405112, 405116, 405118, 405119, 405120, 405122, 405124, 405128, 405129, 405136, 405144, 405145, 405146, 405147, 405149, 405153, 405154, 405254, 405269, 405270, 405404, 405408, 405412, 405416, 405418, 405420, 405422, 405424, 405428) K230283 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared Mar 2023. https://www.510kdatabase.net/k230308/ 2023-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k230308-alma-harmony-fda-510k.jpg K230308 - Alma Harmony K230308 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Alma Lasers, Inc.. Cleared Mar 2023. https://www.510kdatabase.net/k221257/ 2023-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k221257-spectrawave-imaging-system-fda-510k.jpg K221257 - SpectraWAVE Imaging System K221257 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Spectrawave, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k221641/ 2023-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k221641-terragene-bionova-hyper-biological-fda-510k.jpg K221641 - Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene® Bionova® NanoBio Auto-reader Incubator (BNB) K221641 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terragene S.A.. Cleared Feb 2023. https://www.510kdatabase.net/k221705/ 2023-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k221705-u2-total-knee-system-pf-fda-510k.jpg K221705 - U2 Total Knee System-PF+ K221705 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: United Orthopedic Corporation. Cleared Feb 2023. https://www.510kdatabase.net/k221711/ 2023-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k221711-accuicas-fda-510k.jpg K221711 - AccuICAS K221711 is a FDA 510(k) cleared radiology medical device. Manufacturer: ArteryFlow Technology Co., Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k221790/ 2023-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k221790-harmonic-700-shears-fda-510k.jpg K221790 - HARMONIC 700 Shears K221790 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon Endo-Surgery, LLC. Cleared Feb 2023. https://www.510kdatabase.net/k222240/ 2023-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k222240-explorer-air-ii-fda-510k.jpg K222240 - EXPLORER AIR® II K222240 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Surgvision GmbH. Cleared Feb 2023. https://www.510kdatabase.net/k222481/ 2023-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k222481-purastat-fda-510k.jpg K222481 - PuraStat K222481 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3-D Matrix, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k222507/ 2023-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k222507-mobility-scooter-models-w3431q-w3431r-fda-510k.jpg K222507 - Mobility Scooter (Models: W3431Q, W3431R) K222507 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zhejiang Innuovo Rehabilitation Devices Co.,Ltd. Cleared Feb 2023. https://www.510kdatabase.net/k223116/ 2023-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k223116-8x-10-6xxx-camera-head-fda-510k.jpg K223116 - 8X-10-6XXX Camera Head K223116 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Santa Barbara Imaging Systems. Cleared Feb 2023. https://www.510kdatabase.net/k223272/ 2023-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k223272-surblate-ablation-system-fda-510k.jpg K223272 - SurBlate Ablation System K223272 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Mima-Pro Scientific, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k223392/ 2023-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k223392-revcon-tm-screw-system-fda-510k.jpg K223392 - REVCON (TM) Screw System K223392 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Voom Medical Devices, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k223618/ 2023-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k223618-ipl-hair-removal-device-models-ui06-pn-fda-510k.jpg K223618 - IPL Hair Removal Device, Model(s): UI06 PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD K223618 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Ulike Smart Electronics Co., Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k230038/ 2023-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k230038-misslan-pregnancy-rapid-test-strip-fda-510k.jpg K230038 - MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream) K230038 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Guangzhou Decheng Biotechnology Co., Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k230245/ 2023-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k230245-lnk-spinal-fixation-systemopenloc-l-fda-510k.jpg K230245 - LnK Spinal Fixation System/OpenLoc-L Spinal Fixation System K230245 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: L & K Biomed Co., Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k230248/ 2023-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k230248-viola-fda-510k.jpg K230248 - VIOLA K230248 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vascular Graft Solutions, Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k211181/ 2023-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k211181-idylla-msi-test-fda-510k.jpg K211181 - Idylla MSI Test K211181 is a FDA 510(k) cleared pathology medical device. Manufacturer: Biocartis NV. Cleared Feb 2023. https://www.510kdatabase.net/k220035/ 2023-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k220035-milli-vaginal-dilator-fda-510k.jpg K220035 - Milli Vaginal Dilator K220035 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Materna Medical. Cleared Feb 2023. https://www.510kdatabase.net/k222173/ 2023-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k222173-saneso-lens-wash-bottle-assembly-san-fda-510k.jpg K222173 - Saneso Lens Wash Bottle Assembly (SAN-LWB-A) K222173 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Saneso, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k223075/ 2023-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k223075-ogmend-implant-enhancement-system-fda-510k.jpg K223075 - Ogmend® Implant Enhancement System K223075 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Woven Orthopedic Technologies. Cleared Feb 2023. https://www.510kdatabase.net/k223223/ 2023-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k223223-bencox-mirabo-z-cup-cortinium-fda-510k.jpg K223223 - BENCOX Mirabo Z Cup Cortinium K223223 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corentec Co., Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k223253/ 2023-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k223253-non-sterile-zirconia-block-arena-star-fda-510k.jpg K223253 - Non-Sterile Zirconia Block (ARENA Star, Mont Blanc) K223253 is a FDA 510(k) cleared dental medical device. Manufacturer: Arum Dentistry Co., Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k213431/ 2023-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k213431-handheld-pulse-oximeter-fda-510k.jpg K213431 - Handheld Pulse Oximeter K213431 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Witleaf Medical Electronics Co., Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k221702/ 2023-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k221702-compuflo-epidural-computer-controlled-fda-510k.jpg K221702 - CompuFlo Epidural Computer Controlled Anesthesia System K221702 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Milestone Scientific, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k211554/ 2023-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k211554-innogenic-non-resorbable-membrane-fda-510k.jpg K211554 - InnoGenic Non-resorbable Membrane K211554 is a FDA 510(k) cleared dental medical device. Manufacturer: Cowellmedi Co., Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k213805/ 2023-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k213805-magnetom-vida-fda-510k.jpg K213805 - MAGNETOM Vida K213805 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k213891/ 2023-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k213891-realnow-fda-510k.jpg K213891 - RealNow K213891 is a FDA 510(k) cleared radiology medical device. Manufacturer: Yiwei Medical Technology Co., Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k221592/ 2023-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k221592-aview-lung-nodule-cad-fda-510k.jpg K221592 - AVIEW Lung Nodule CAD K221592 is a FDA 510(k) cleared radiology medical device. Manufacturer: Coreline Soft Co., Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k221614/ 2023-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k221614-tytocare-lung-sounds-analyzer-fda-510k.jpg K221614 - TytoCare Lung Sounds Analyzer K221614 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Tyto Care , Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k221845/ 2023-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k221845-blue-sky-bio-aligner-g-blue-sky-plan-fda-510k.jpg K221845 - Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G K221845 is a FDA 510(k) cleared dental medical device. Manufacturer: Blue Sky Bio, LLC. Cleared Feb 2023. https://www.510kdatabase.net/k222386/ 2023-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k222386-visionbody-fda-510k.jpg K222386 - Visionbody K222386 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Vb Technologies AG. Cleared Feb 2023. https://www.510kdatabase.net/k222757/ 2023-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k222757-clarus-viewer-fda-510k.jpg K222757 - Clarus Viewer K222757 is a FDA 510(k) cleared radiology medical device. Manufacturer: Clarus Viewer Corporation. Cleared Feb 2023. https://www.510kdatabase.net/k223231/ 2023-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k223231-ti-largo-cervical-interbody-system-fda-510k.jpg K223231 - Ti-Largo Cervical Interbody System K223231 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Flospine. Cleared Feb 2023. https://www.510kdatabase.net/k223582/ 2023-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k223582-mectalock-ti-triple-loaded-suture-anchor-fda-510k.jpg K223582 - MectaLock TI Triple Loaded Suture Anchor K223582 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Feb 2023. https://www.510kdatabase.net/k223759/ 2023-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k223759-arthrex-synergyid-endoscopic-imaging-fda-510k.jpg K223759 - Arthrex SynergyID Endoscopic Imaging System K223759 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Arthex, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k223810/ 2023-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k223810-kawasumi-multiple-sample-adapter-with-fda-510k.jpg K223810 - Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) K223810 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sb-Kawasumi Laboratories, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k223852/ 2023-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k223852-vyspan-pct-system-fda-510k.jpg K223852 - VySpan™ PCT System K223852 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Vy Spine, LLC. Cleared Feb 2023. https://www.510kdatabase.net/k223884/ 2023-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k223884-elitone-urge-urinary-incontinence-device-fda-510k.jpg K223884 - ELITONE Urge Urinary Incontinence Device K223884 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Elidah, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k223900/ 2023-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k223900-babylance-safety-heelstick-blm-bln-blp-fda-510k.jpg K223900 - babyLance Safety Heelstick (BLM, BLN, BLP) K223900 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Clinical Innovations, LLC. Cleared Feb 2023. https://www.510kdatabase.net/k230205/ 2023-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k230205-veloxion-system-fda-510k.jpg K230205 - Veloxion System K230205 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Corinth Medtech, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k230339/ 2023-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k230339-esocheck-cell-collection-device-fda-510k.jpg K230339 - EsoCheck Cell Collection Device K230339 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Lucid Diagnostics, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/den220063/ 2023-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/den220063-caption-interpretation-automated-fda-510k.jpg DEN220063 - Caption Interpretation Automated Ejection Fraction Software DEN220063 is a FDA 510(k) cleared radiology medical device. Manufacturer: Caption Health, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/den220065/ 2023-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/den220065-pill-sense-system-fda-510k.jpg DEN220065 - Pill Sense System DEN220065 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Enterasense , Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k213863/ 2023-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k213863-everion-system-fda-510k.jpg K213863 - Everion+ System K213863 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biofourmis Singapore Pte., Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k221559/ 2023-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k221559-disposable-surgical-gown-level-4-fda-510k.jpg K221559 - Disposable Surgical Gown, Level 4 K221559 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Stringking. Cleared Feb 2023. https://www.510kdatabase.net/k221564/ 2023-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k221564-brainomix-360-e-aspects-fda-510k.jpg K221564 - Brainomix 360 e-ASPECTS K221564 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainomix Limited. Cleared Feb 2023. https://www.510kdatabase.net/k221591/ 2023-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k221591-camera-system-camera-control-unit-fda-510k.jpg K221591 - Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source K221591 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Schoelly Fiberoptic GmbH. Cleared Feb 2023. https://www.510kdatabase.net/k222579/ 2023-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k222579-belun-sleep-system-bls-100-fda-510k.jpg K222579 - Belun Sleep System BLS-100 K222579 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Belun Technology Company Limited. Cleared Feb 2023. https://www.510kdatabase.net/k223161/ 2023-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k223161-oxy-1-system-fda-510k.jpg K223161 - OXY-1 System K223161 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abiomed, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k223209/ 2023-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k223209-elekta-unity-fda-510k.jpg K223209 - Elekta Unity K223209 is a FDA 510(k) cleared radiology medical device. Manufacturer: Elekta Solutions AB. Cleared Feb 2023. https://www.510kdatabase.net/k223216/ 2023-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k223216-symphony-thrombectomy-system-fda-510k.jpg K223216 - Symphony Thrombectomy System K223216 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Truvic Medical, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k223229/ 2023-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k223229-mosaiq-ois-oncology-information-system-fda-510k.jpg K223229 - MOSAIQ® OIS (Oncology Information System) K223229 is a FDA 510(k) cleared radiology medical device. Manufacturer: Elekta Solutions AB. Cleared Feb 2023. https://www.510kdatabase.net/k223233/ 2023-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k223233-monaco-rtp-system-fda-510k.jpg K223233 - Monaco RTP System K223233 is a FDA 510(k) cleared radiology medical device. Manufacturer: Elekta Solutions AB. Cleared Feb 2023. https://www.510kdatabase.net/k223262/ 2023-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k223262-renuvion-apr-handpiece-fda-510k.jpg K223262 - Renuvion® APR Handpiece K223262 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Apyx Medical Corporation. Cleared Feb 2023. https://www.510kdatabase.net/k223544/ 2023-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k223544-led-light-therapy-mask-fm-01-fm-02-fm-03-fda-510k.jpg K223544 - LED light therapy mask (FM-01, FM-02, FM-03) K223544 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Guangdong Newdermo Biotech Co., Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k223797/ 2023-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k223797-neuro20-pro-system-fda-510k.jpg K223797 - Neuro20 Pro System K223797 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Neuro20 Technologies. Cleared Feb 2023. https://www.510kdatabase.net/k230212/ 2023-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k230212-orthobutton-al-fda-510k.jpg K230212 - OrthoButton AL K230212 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Riverpoint Medical, LLC. Cleared Feb 2023. https://www.510kdatabase.net/k230216/ 2023-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k230216-1688-4k-camera-control-unit-with-fda-510k.jpg K230216 - 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000) K230216 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker. Cleared Feb 2023. https://www.510kdatabase.net/k230227/ 2023-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k230227-t-line-hernia-mesh-fda-510k.jpg K230227 - T-Line Hernia Mesh K230227 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Deep Blue Medical Advances, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k230228/ 2023-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k230228-iridex-532-laser-fda-510k.jpg K230228 - Iridex 532 Laser K230228 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Iridex Corporation. Cleared Feb 2023. https://www.510kdatabase.net/k230241/ 2023-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k230241-jumong-general-fda-510k.jpg K230241 - Jumong General K230241 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sg Healthcare Co, Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k212587/ 2023-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k212587-3d-rd-s-fda-510k.jpg K212587 - 3D-RD-S K212587 is a FDA 510(k) cleared radiology medical device. Manufacturer: Radiopharmaceutical Imaging and Dosimetry, LLC. Cleared Feb 2023. https://www.510kdatabase.net/k221329/ 2023-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k221329-eyer-retinal-camera-nm-std-fda-510k.jpg K221329 - Eyer Retinal Camera NM-STD K221329 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Phelcom Technologies. Cleared Feb 2023. https://www.510kdatabase.net/k221469/ 2023-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k221469-pati-protector-against-tongue-injury-fda-510k.jpg K221469 - PATI (Protector Against Tongue Injury) K221469 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neurovice, LLC. Cleared Feb 2023. https://www.510kdatabase.net/k221629/ 2023-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k221629-tri-staple-20-black-circular-reloads-fda-510k.jpg K221629 - Tri-Staple™ 2.0 Black Circular Reloads (for use with Signia™ Circular Adapters) K221629 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien. Cleared Feb 2023. https://www.510kdatabase.net/k221741/ 2023-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k221741-traus-air-dental-handpiece-fda-510k.jpg K221741 - TRAUS Air Dental Handpiece K221741 is a FDA 510(k) cleared dental medical device. Manufacturer: Saeshin Precision Co., Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k221903/ 2023-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k221903-delta-iii-pro-fda-510k.jpg K221903 - Delta III Pro K221903 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Dornier Medtech America, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k223298/ 2023-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k223298-sterile-latex-examination-gloves-fda-510k.jpg K223298 - Sterile Latex Examination Gloves Powder Free (S, M, L, Extra L) K223298 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shandong Intco Medical Products Co, Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k223492/ 2023-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k223492-efoldi-scooter-lite-fda-510k.jpg K223492 - eFOLDi Scooter, Lite K223492 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Suntech UK , Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k230180/ 2023-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k230180-rosa-knee-system-fda-510k.jpg K230180 - Rosa Knee System K230180 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthosoft Inc. (d/b/a) Zimmer CAS. Cleared Feb 2023. https://www.510kdatabase.net/k230197/ 2023-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k230197-bonemri-v16-fda-510k.jpg K230197 - BoneMRI v1.6 K230197 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mriguidance B.V.. Cleared Feb 2023. https://www.510kdatabase.net/k230201/ 2023-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k230201-disposable-pre-calibrated-brain-biopsy-fda-510k.jpg K230201 - Disposable Pre-calibrated Brain Biopsy Needle 2.0 K230201 is a FDA 510(k) cleared neurology medical device. Manufacturer: PAJUNK GmbH Medizintechnologie. Cleared Feb 2023. https://www.510kdatabase.net/k230208/ 2023-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k230208-swoop-portable-mr-imaging-system-fda-510k.jpg K230208 - Swoop® Portable MR Imaging System™ K230208 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hyperfine, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k230371/ 2023-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k230371-the-alma-soprano-titanium-fda-510k.jpg K230371 - The Alma Soprano Titanium K230371 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Alma Lasers, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k213348/ 2023-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k213348-bond-mmr-antibody-panel-fda-510k.jpg K213348 - BOND MMR Antibody Panel K213348 is a FDA 510(k) cleared pathology medical device. Manufacturer: Leica Biosystems Newcastle, Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k214068/ 2023-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k214068-quantia-ige-fda-510k.jpg K214068 - Quantia IgE K214068 is a FDA 510(k) cleared immunology medical device. Manufacturer: Biokit, S.A.. Cleared Feb 2023. https://www.510kdatabase.net/k222184/ 2023-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k222184-introducer-sheath-kits-fda-510k.jpg K222184 - Introducer Sheath Kits K222184 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Beijing Demax Medical Technology Co.,Ltd. Cleared Feb 2023. https://www.510kdatabase.net/k222259/ 2023-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k222259-neona-15t-mri-system-fda-510k.jpg K222259 - NEONA 1.5T MRI System K222259 is a FDA 510(k) cleared radiology medical device. Manufacturer: Time Medical Limited. Cleared Feb 2023. https://www.510kdatabase.net/k223537/ 2023-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k223537-freestyle-libre-2-system-freestyle-fda-510k.jpg K223537 - FreeStyle Libre 2 System, FreeStyle Libre 3 System K223537 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Diabetes Care, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k223612/ 2023-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k223612-ranfac-lateral-access-bone-marrow-fda-510k.jpg K223612 - Ranfac Lateral Access Bone Marrow Aspiration Needle (CRVS-BMA-LA) K223612 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ranfac Corporation. Cleared Feb 2023. https://www.510kdatabase.net/k223643/ 2023-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k223643-verifine-ease-lancing-device-verifine-fda-510k.jpg K223643 - Verifine® Ease Lancing Device, Verifine® Lancing Device K223643 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Promisemed Hangzhou Meditech Co., Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k220214/ 2023-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k220214-painless-ipl-system-kdt750-fda-510k.jpg K220214 - Painless IPL System - KDT750 K220214 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shanghai Omni Laser Skinology Co., Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k221861/ 2023-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k221861-flonavi-endoscopic-fluorescence-fda-510k.jpg K221861 - FloNavi Endoscopic Fluorescence Imaging System K221861 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Guangdong Optomedic Technologies, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k213755/ 2023-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k213755-peridot-pt-anterior-cervical-fda-510k.jpg K213755 - Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT Intervertebral body fusion system K213755 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Gbs Commonwealth Co., Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k220276/ 2023-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k220276-infrared-thermometer-tet-351-fda-510k.jpg K220276 - Infrared Thermometer TET-351 K220276 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Truly Instrument Limited. Cleared Feb 2023. https://www.510kdatabase.net/k221043/ 2023-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k221043-doctor-tecar-plus-doctor-tecar-smart-fda-510k.jpg K221043 - Doctor Tecar Plus, Doctor Tecar Smart K221043 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Mectronic Medicale S.R.L.. Cleared Feb 2023. https://www.510kdatabase.net/k221483/ 2023-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k221483-flowsaver-blood-return-system-fda-510k.jpg K221483 - FlowSaver Blood Return System K221483 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inari Medical, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k221513/ 2023-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k221513-equashield-closed-system-transfer-device-fda-510k.jpg K221513 - Equashield Closed System Transfer Device K221513 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Equashield Medical , Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k221645/ 2023-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k221645-prosteptm-mis-5mm-chamfer-screw-system-fda-510k.jpg K221645 - PROstep(TM) MIS 5mm Chamfer Screw System K221645 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wright Medical Technology. Cleared Feb 2023. https://www.510kdatabase.net/k222226/ 2023-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k222226-eon-fda-510k.jpg K222226 - EON K222226 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Dominion Aesthetic Technologies, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k222588/ 2023-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k222588-temp-pal-smart-thermometer-patch-model-fda-510k.jpg K222588 - Temp Pal (Smart Thermometer Patch) Model Number: STP-MB01-1 K222588 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Iweecare Co., Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k222695/ 2023-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k222695-trocarwash-system-fda-510k.jpg K222695 - troCarWash™ System K222695 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Biotex, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k222971/ 2023-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k222971-ultrabutton-quad-adjustable-fixation-fda-510k.jpg K222971 - ULTRABUTTON QUAD Adjustable Fixation Device K222971 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k222977/ 2023-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k222977-dsps-prominent-masks-fda-510k.jpg K222977 - DSPS-Prominent™ Masks K222977 is a FDA 510(k) cleared radiology medical device. Manufacturer: Macromedics BV. Cleared Feb 2023. https://www.510kdatabase.net/k223466/ 2023-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k223466-uretero1-single-use-digital-flexible-fda-510k.jpg K223466 - Uretero1 Single-Use Digital Flexible Ureteroscope (standard deflection), PN UROSD101 K223466 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: STERIS Corporation. Cleared Feb 2023. https://www.510kdatabase.net/k223497/ 2023-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k223497-spectrum-saliva-collection-device-fda-510k.jpg K223497 - Spectrum Saliva Collection Device K223497 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Spectrum Solutions, LLC. Cleared Feb 2023. https://www.510kdatabase.net/k223545/ 2023-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k223545-apro-70-catheter-and-alembic-fda-510k.jpg K223545 - APRO 70 Catheter and Alembic Aspiration Tubing K223545 is a FDA 510(k) cleared neurology medical device. Manufacturer: Alembic, LLC. Cleared Feb 2023. https://www.510kdatabase.net/k223798/ 2023-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k223798-glidewell-tuffsplint-appliance-resin-fda-510k.jpg K223798 - Glidewell TuffSplint™ Appliance Resin K223798 is a FDA 510(k) cleared dental medical device. Manufacturer: Prismatik Dentalcraft, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k223820/ 2023-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k223820-ezdent-i-e2-prora-view-smart-m-viewer-fda-510k.jpg K223820 - EzDent-i / E2 / Prora View/ Smart M Viewer K223820 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ewoosoft Co., Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k223897/ 2023-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k223897-excipio-lv-thrombectomy-device-fda-510k.jpg K223897 - Excipio LV Thrombectomy Device K223897 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Contego Medical, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/den210022/ 2023-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/den210022-pmd-200-fda-510k.jpg DEN210022 - PMD-200 DEN210022 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Medasense Biometrics , Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k212194/ 2023-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k212194-stryker-q-guidance-system-with-cranial-fda-510k.jpg K212194 - Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting System K212194 is a FDA 510(k) cleared neurology medical device. Manufacturer: Stryker Corporation. Cleared Feb 2023. https://www.510kdatabase.net/k213844/ 2023-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k213844-surgical-gown-fda-510k.jpg K213844 - Surgical Gown K213844 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bayteks Teknik Tekstil San. VE Tic. A.S.. Cleared Feb 2023. https://www.510kdatabase.net/k220698/ 2023-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k220698-bambino-3-s3-and-s3-swing-u3-and-u3-fda-510k.jpg K220698 - Bambino 3, S3 and S3 Swing, U3 and U3 Light, X K220698 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Panthera AB. Cleared Feb 2023. https://www.510kdatabase.net/k221784/ 2023-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k221784-single-use-video-pancreaticobiliary-fda-510k.jpg K221784 - Single-use Video Pancreaticobiliary Scope, PB Digital Controller K221784 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Micro-Tech (Nanjing) Co., Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k222065/ 2023-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k222065-passeo-35-xeo-peripheral-dilatation-fda-510k.jpg K222065 - Passeo-35 Xeo Peripheral Dilatation Catheter K222065 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biotronik, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k222622/ 2023-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k222622-disposable-infusion-bag-for-parenteral-fda-510k.jpg K222622 - Disposable Infusion Bag for Parenteral Nutrition K222622 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Beijing L&Z Medical Technology Development Co., Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k222755/ 2023-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k222755-umr-680-fda-510k.jpg K222755 - uMR 680 K222755 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Intelligence Co., Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k223028/ 2023-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k223028-uct-atlas-astound-with-uws-ct-dual-fda-510k.jpg K223028 - uCT ATLAS Astound with uWS-CT-Dual Energy Analysis K223028 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k223056/ 2023-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k223056-jaws-nitinol-staple-system-fda-510k.jpg K223056 - JAWS Nitinol Staple System K223056 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paragon 28, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k223327/ 2023-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k223327-sterile-aesthetic-cannula-and-fda-510k.jpg K223327 - Sterile Aesthetic Cannula and Hypodermic Needle K223327 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shanghai Kindly Enterprise Development Group Co., Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k223477/ 2023-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k223477-pmma-blocks-for-dental-use-fda-510k.jpg K223477 - PMMA Blocks for Dental Use K223477 is a FDA 510(k) cleared dental medical device. Manufacturer: Aidite (Qinhuangdao) Technology Co., Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k223478/ 2023-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k223478-vitek-2-ast-gram-negative-plazomicin-fda-510k.jpg K223478 - VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL) K223478 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k223524/ 2023-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k223524-ipl-hair-removal-models-sb01-sb01a-fda-510k.jpg K223524 - IPL Hair Removal, Model(s): SB01, SB01A, SB01B, SB01C, SN02, SN03 K223524 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Morlaser Shenzhen Co., Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k223733/ 2023-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k223733-carto-3-ep-navigation-system-with-fda-510k.jpg K223733 - CARTO® 3 EP Navigation System with CARTOSOUND™ 4D Version 7.4 K223733 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biosense Webster, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k223766/ 2023-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k223766-nuvision-nav-ultrasound-catheter-fda-510k.jpg K223766 - NUVISION™ NAV Ultrasound Catheter K223766 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biosense Webster, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k223770/ 2023-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k223770-sonopet-1q-3-7cm-1q-large-fda-510k.jpg K223770 - Sonopet 1Q 3 7cm 1Q Large K223770 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker Corporation. Cleared Feb 2023. https://www.510kdatabase.net/k223832/ 2023-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k223832-vivid-s60n-vivid-s70n-fda-510k.jpg K223832 - Vivid S60N, Vivid S70N K223832 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical System Ultrasound and Primary Care Diagnostics. Cleared Feb 2023. https://www.510kdatabase.net/k230118/ 2023-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k230118-bony-trauma-extremity-system-btes-fda-510k.jpg K230118 - Bony Trauma Extremity System (BTES) Screw Range, NX Nail K230118 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Field Orthopaedics Pty, Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k213669/ 2023-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k213669-lightscalpel-ls-4020-fda-510k.jpg K213669 - LIGHTSCALPEL LS-4020 K213669 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lightscalpel, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k221523/ 2023-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k221523-tanning-lamp-fda-510k.jpg K221523 - Tanning Lamp K221523 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Unilam Co., Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k221874/ 2023-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k221874-altis-single-incision-sling-system-fda-510k.jpg K221874 - Altis Single Incision Sling System K221874 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Coloplast A/S. Cleared Feb 2023. https://www.510kdatabase.net/k222271/ 2023-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k222271-verisafe-safety-sterile-needles-fda-510k.jpg K222271 - Verisafe Safety sterile needles K222271 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Promisemed Hangzhou Meditech Co., Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k222389/ 2023-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k222389-zeus-system-fda-510k.jpg K222389 - ZEUS System K222389 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: iRhythm Technologies, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k222869/ 2023-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k222869-arm-blood-pressure-monitor-fda-510k.jpg K222869 - Arm Blood Pressure Monitor K222869 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Andon Health Co, Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k223022/ 2023-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k223022-sc-honkytonk-ptca-balloon-dilatation-fda-510k.jpg K223022 - SC HONKYTONK PTCA Balloon Dilatation Catheter K223022 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sino Medical Sciences Technology, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k223046/ 2023-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k223046-xpert-fii-fv-fda-510k.jpg K223046 - Xpert® FII & FV K223046 is a FDA 510(k) cleared hematology medical device. Manufacturer: Cepheid. Cleared Feb 2023. https://www.510kdatabase.net/k223407/ 2023-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k223407-versana-essential-fda-510k.jpg K223407 - Versana Essential K223407 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared Feb 2023. https://www.510kdatabase.net/k223815/ 2023-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k223815-one-drop-lancing-device-fda-510k.jpg K223815 - ONE DROP Lancing Device K223815 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stat Medical Devices. Cleared Feb 2023. https://www.510kdatabase.net/k223891/ 2023-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k223891-cobra-catheter-system-fda-510k.jpg K223891 - Cobra Catheter System K223891 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Endovascular Engineering. Cleared Feb 2023. https://www.510kdatabase.net/k230131/ 2023-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k230131-reshape-calibration-tubes-fda-510k.jpg K230131 - ReShape Calibration Tubes K230131 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Reshape Lifesciences. Cleared Feb 2023. https://www.510kdatabase.net/k230175/ 2023-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k230175-digital-radiography-cxdi-cs01-fda-510k.jpg K230175 - Digital Radiography CXDI-CS01 K230175 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k213757/ 2023-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k213757-endocem-mta-premixed-regular-fda-510k.jpg K213757 - Endocem MTA Premixed Regular K213757 is a FDA 510(k) cleared dental medical device. Manufacturer: Maruchi. Cleared Feb 2023. https://www.510kdatabase.net/k221468/ 2023-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k221468-citregen-tendon-interference-screw-tis-fda-510k.jpg K221468 - Citregen™ Tendon Interference Screw (TIS), Citrelock™ Tendon Fixation Device, Citrespline™ and Citrelock™ ACL Implants K221468 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Acuitive Technologies, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k221490/ 2023-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k221490-tritanium-c-anterior-cervical-cage-fda-510k.jpg K221490 - Tritanium C Anterior Cervical Cage, Tritanium PL Cage, Tritanium TL Curved Posterior Lumbar Cage, Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage, Stryker Spine VLIFT Vertebral Body Replacement System, VLIFT-s Vertebral Body Replacement System, Ascential IBD PEEKc Spacer, Aero-AL Lumbar Cage System, Aero-LL Lumbar Cage System, Aero-C Cervical Cage System, AVS Aria PEEK Spacer, AVS Anchor-C Cervical Cage System, AVS Anchor-L Spacer K221490 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Spine. Cleared Feb 2023. https://www.510kdatabase.net/k221527/ 2023-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k221527-stitchkit-fda-510k.jpg K221527 - StitchKit K221527 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Origami Surgical Inc .. Cleared Feb 2023. https://www.510kdatabase.net/k221672/ 2023-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k221672-creo-electrosurgical-system-with-np1-fda-510k.jpg K221672 - Creo Electrosurgical System with NP1 Instrument K221672 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Creo Medical, Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k223174/ 2023-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k223174-x-pac-expandable-llif-cage-system-fda-510k.jpg K223174 - X-Pac Expandable LLIF Cage System K223174 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Expanding Innovations, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k223225/ 2023-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k223225-8ch-tr-knee-coil-fda-510k.jpg K223225 - 8ch T/R Knee Coil K223225 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen RF Tech Co., Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k212635/ 2023-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k212635-sofjec-fda-510k.jpg K212635 - Sofjec K212635 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hwajin Medical Co., Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k213030/ 2023-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k213030-curiteva-porous-peek-cervical-fda-510k.jpg K213030 - Curiteva Porous PEEK Cervical Interbody Fusion System K213030 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Curiteva, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k221875/ 2023-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k221875-sterilization-pouch-and-roll-fda-510k.jpg K221875 - Sterilization Pouch and Roll K221875 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Qianjiang Kingphar Medical Packaging & Printing Co., Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k222327/ 2023-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k222327-bloomlife-mfm-pro-fda-510k.jpg K222327 - Bloomlife MFM-Pro K222327 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Bloom Technologies NV. Cleared Feb 2023. https://www.510kdatabase.net/k222341/ 2023-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k222341-arrow-02-micron-flat-filter-gvs-fda-510k.jpg K222341 - Arrow 0.2 Micron Flat Filter, GVS K222341 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Arrow International, LLC. Cleared Feb 2023. https://www.510kdatabase.net/k223186/ 2023-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k223186-indigo-aspiration-system-lightning-fda-510k.jpg K223186 - Indigo® Aspiration System – Lightning Bolt Aspiration Tubing K223186 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Penumbra, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k223263/ 2023-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k223263-prevena-plus-125-therapy-unit-fda-510k.jpg K223263 - Prevena Plus 125 Therapy Unit K223263 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3M. Cleared Feb 2023. https://www.510kdatabase.net/k223370/ 2023-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k223370-neatnick-heel-safety-lancet-fda-510k.jpg K223370 - NeatNick Heel Safety Lancet K223370 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Facet Technologies, LLC. Cleared Feb 2023. https://www.510kdatabase.net/k223387/ 2023-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k223387-v8-diagnostic-ultrasound-system-v7-fda-510k.jpg K223387 - V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System K223387 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Medison Co., Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k223439/ 2023-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k223439-signa-victor-fda-510k.jpg K223439 - SIGNA Victor K223439 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare (Tianjin) Company Limited. Cleared Feb 2023. https://www.510kdatabase.net/k223656/ 2023-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k223656-ameriwater-mediqa-reverse-osmosis-fda-510k.jpg K223656 - AmeriWater MediQA Reverse Osmosis System (MSP3HF) K223656 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: AmeriWater, LLC. Cleared Feb 2023. https://www.510kdatabase.net/k223761/ 2023-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k223761-oic-intramedullary-screw-system-fda-510k.jpg K223761 - OIC Intramedullary Screw System K223761 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthopaedic Implant Company. Cleared Feb 2023. https://www.510kdatabase.net/k223767/ 2023-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k223767-ortho-guidance-precision-knee-software-fda-510k.jpg K223767 - Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance System K223767 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Leibinger GmbH & Co KG. Cleared Feb 2023. https://www.510kdatabase.net/k223779/ 2023-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k223779-empowr-blade-stem-fda-510k.jpg K223779 - EMPOWR™ blade stem K223779 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Encore Medical, LLC. Cleared Feb 2023. https://www.510kdatabase.net/k223859/ 2023-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k223859-rhino-non-sterile-powder-free-nitrile-fda-510k.jpg K223859 - Rhino Non-sterile Powder-Free Nitrile Exam Glove – Periwinkle Color Tested for Use with Chemotherapy Drugs and Fentanyl K223859 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Rhino Health, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k230196/ 2023-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k230196-syngovia-viewgo-va40a-fda-510k.jpg K230196 - syngo.via View&GO VA40A K230196 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Healthcare GmbH. Cleared Feb 2023. https://www.510kdatabase.net/k230207/ 2023-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k230207-acuson-juniper-diagnostic-ultrasound-fda-510k.jpg K230207 - ACUSON Juniper Diagnostic Ultrasound System, ACUSON Juniper Select Diagnostic Ultrasound System K230207 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k213629/ 2023-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k213629-smile-fda-510k.jpg K213629 - SMILE K213629 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nu Eyne Co., Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k213853/ 2023-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k213853-renasys-wf-white-foam-npwt-dressing-fda-510k.jpg K213853 - RENASYS™-WF White Foam NPWT Dressing Small K213853 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith and Nephew Medical Limited. Cleared Feb 2023. https://www.510kdatabase.net/k220435/ 2023-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k220435-sejong-surgical-gown-soft-fda-510k.jpg K220435 - SEJONG Surgical Gown Soft K220435 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sejong Healthcare Co., Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k220657/ 2023-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k220657-medical-infrared-thermometer-model-rst-fda-510k.jpg K220657 - Medical Infrared Thermometer (Model: RST-TC59-1001, RST-TC60-1001) K220657 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zhejiang Rongsheng Industrial Co., Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k220715/ 2023-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k220715-artsmedia-in-vitro-culture-medium-am-fda-510k.jpg K220715 - ARTSMedia In Vitro Culture Medium (AM-IVC Medium) K220715 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Artsmedia Denmark Aps. Cleared Feb 2023. https://www.510kdatabase.net/k221452/ 2023-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k221452-dilumen-c1-ez1-and-tool-mount-fda-510k.jpg K221452 - DiLumen C1, EZ1 and Tool Mount K221452 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Lumendi, LLC. Cleared Feb 2023. https://www.510kdatabase.net/k221474/ 2023-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k221474-primus-healthcare-sterilizer-model-fda-510k.jpg K221474 - PRIMUS Healthcare Sterilizer (Model PSS11-HC) K221474 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Primus Sterilizer Company, LLC. Cleared Feb 2023. https://www.510kdatabase.net/k221476/ 2023-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k221476-perifit-fda-510k.jpg K221476 - Perifit K221476 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: X6 Innovations. Cleared Feb 2023. https://www.510kdatabase.net/k222129/ 2023-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k222129-nitrile-examination-powder-free-glove-fda-510k.jpg K222129 - Nitrile Examination Powder Free Glove, Blue Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim, Nitrile Examination Powder Free Glove, Black Tested For Use With 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim K222129 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Top Glove Medical (Thailand) Co., Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k222513/ 2023-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k222513-glass-ceramics-fda-510k.jpg K222513 - Glass Ceramics K222513 is a FDA 510(k) cleared dental medical device. Manufacturer: Yilink (Tianjin) Biotechnology Co., Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k222596/ 2023-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k222596-s90-exp-series-digital-color-doppler-fda-510k.jpg K222596 - S90 Exp Series Digital Color Doppler Ultrasound System K222596 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sonoscape Medical Corp.. Cleared Feb 2023. https://www.510kdatabase.net/k223194/ 2023-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k223194-glass-ceramic-fda-510k.jpg K223194 - Glass Ceramic K223194 is a FDA 510(k) cleared dental medical device. Manufacturer: Shenzhen Xiangtong Co., Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k223208/ 2023-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k223208-safety-lancet-fda-510k.jpg K223208 - Safety Lancet K223208 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Suzhou Zhenwu Medical Co., Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k223249/ 2023-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k223249-pro-tx-endorectal-balloon-prot-25-fda-510k.jpg K223249 - Pro-Tx Endorectal Balloon (PROT-25) K223249 is a FDA 510(k) cleared radiology medical device. Manufacturer: Dxtx Medical, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k223413/ 2023-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k223413-pisces-sa-standalone-alif-interbody-fda-510k.jpg K223413 - Pisces™-SA STANDALONE ALIF Interbody System K223413 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osseus Fusion Systems. Cleared Feb 2023. https://www.510kdatabase.net/k223425/ 2023-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k223425-mdai-viewer-fda-510k.jpg K223425 - MD.ai Viewer K223425 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mdai, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k223438/ 2023-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k223438-teligen-system-peripheral-motor-nerve-fda-510k.jpg K223438 - TELIGEN System Peripheral Motor Nerve Stimulation Indications K223438 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medos International SARL. Cleared Feb 2023. https://www.510kdatabase.net/k223467/ 2023-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k223467-disposable-isolation-gown-fda-510k.jpg K223467 - Disposable Isolation Gown K223467 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Nanning Tecbod Biological Technology Co., Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k223680/ 2023-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k223680-eneka-pro-fda-510k.jpg K223680 - Eneka Pro K223680 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Termosalud. Cleared Feb 2023. https://www.510kdatabase.net/k223786/ 2023-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k223786-orthex-external-fixation-system-fda-510k.jpg K223786 - Orthex External Fixation System K223786 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OrthoPediatrics Corp.. Cleared Feb 2023. https://www.510kdatabase.net/k203211/ 2023-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k203211-insulin-syringe-with-integrated-needle-fda-510k.jpg K203211 - Insulin syringe with integrated needle DL K203211 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Dlp Medical Products, Corp.. Cleared Feb 2023. https://www.510kdatabase.net/k220505/ 2023-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k220505-attiva-fda-510k.jpg K220505 - ATTIVA K220505 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Italian Engineering S.R.L.. Cleared Feb 2023. https://www.510kdatabase.net/k221223/ 2023-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k221223-extricare-3000-negative-wound-pressure-fda-510k.jpg K221223 - extriCARE® 3000 Negative Wound Pressure Therapy System K221223 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Alleva Medical Devices. Cleared Feb 2023. https://www.510kdatabase.net/k221400/ 2023-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k221400-hygh-tec-drainage-fda-510k.jpg K221400 - hygh-tec drainage K221400 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Creative Balloons GmbH. Cleared Feb 2023. https://www.510kdatabase.net/k221694/ 2023-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k221694-external-drainage-system-fda-510k.jpg K221694 - External Drainage System K221694 is a FDA 510(k) cleared neurology medical device. Manufacturer: Jmed(Shenzhen) Technology Limited. Cleared Feb 2023. https://www.510kdatabase.net/k222041/ 2023-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k222041-cygnus-c-standalone-acif-system-fda-510k.jpg K222041 - CYGNUS-C Standalone ACIF System K222041 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: GS Medical Co., Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k222073/ 2023-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k222073-vitek-2-ast-gram-negative-cefazolin-1-fda-510k.jpg K222073 - VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL) K222073 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k223338/ 2023-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k223338-toothsi-smilealigners-fda-510k.jpg K223338 - Toothsi, Smilealigners K223338 is a FDA 510(k) cleared dental medical device. Manufacturer: Makeo Healthcare Technologies Private Limited. Cleared Feb 2023. https://www.510kdatabase.net/k223559/ 2023-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k223559-nephron-nitrile-powder-free-nitrile-fda-510k.jpg K223559 - Nephron Nitrile Powder-Free Nitrile Examination Gloves (Tested For Use With Chemotherapy Drugs) K223559 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Nephron Pharmaceuticals Corporation. Cleared Feb 2023. https://www.510kdatabase.net/k223678/ 2023-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k223678-sterile-syringes-for-single-use-fda-510k.jpg K223678 - Sterile Syringes for Single Use K223678 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shanghai Kindly Enterprise Development Group Co., Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k230063/ 2023-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k230063-g-surgical-marksman-spinal-deformity-fda-510k.jpg K230063 - G Surgical Marksman Spinal Deformity System K230063 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: G Surgical, LLC. Cleared Feb 2023. https://www.510kdatabase.net/k230073/ 2023-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k230073-okti-fda-510k.jpg K230073 - Okti K230073 is a FDA 510(k) cleared neurology medical device. Manufacturer: Compumedics Limited. Cleared Feb 2023. https://www.510kdatabase.net/k230089/ 2023-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k230089-ethicon-linx-esophagus-sizing-tool-fda-510k.jpg K230089 - ETHICON LINX® Esophagus Sizing Tool K230089 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Torax Medical, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k221472/ 2023-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k221472-filter-and-hmefilter-fda-510k.jpg K221472 - Filter and HME/Filter K221472 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ningbo Huakun Medical Equipment Co., Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k222247/ 2023-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k222247-hailie-sensor-nf0110-fda-510k.jpg K222247 - Hailie Sensor NF0110 K222247 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Adherium (Nz), Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k222685/ 2023-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k222685-nira-model-2-fda-510k.jpg K222685 - NIRA Model 2 K222685 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Dermal Photonics Corp. Cleared Feb 2023. https://www.510kdatabase.net/k223038/ 2023-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k223038-access-cortisol-fda-510k.jpg K223038 - Access Cortisol K223038 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k223304/ 2023-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k223304-disposable-isolation-gowns-smlxlxxlxxxl-fda-510k.jpg K223304 - Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) K223304 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Xiamen Probtain Medical Technology Co., Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k222451/ 2023-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k222451-save-gbr-fda-510k.jpg K222451 - SAVE GBR K222451 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentis Co., Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k222928/ 2023-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k222928-resona-r9-resona-r9-exp-resona-r9-pro-fda-510k.jpg K222928 - Resona R9/ Resona R9 Exp/ Resona R9 Pro/ Resona R9S/ Nuewa R9/ Nuewa R9 Exp Diagnostic Ultrasound Sysem, Nuewa R9 Pro/ Nuewa R9S/ Resona 7/ Resona 7CV/Resona 7EXP/Resona 7S/ Resona 70B Diagnostic Ultrasound System, Resona 7PRO/Imagyn 7/ Resona Y/Resona R9W/Resona R7W Nuewa R9W/Nuewa R7W Diagnostic Ultrasound System K222928 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k223146/ 2023-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k223146-evolution-spine-interbody-system-fda-510k.jpg K223146 - EVOLUTION SPINE Interbody System K223146 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Evolution Spine. Cleared Feb 2023. https://www.510kdatabase.net/k223686/ 2023-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k223686-medical-protective-masks-fda-510k.jpg K223686 - Medical Protective Masks K223686 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Qinhuangdao Taizhi Medical Technology Co., Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k212701/ 2023-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k212701-eminent-spine-3d-cervical-interbody-fda-510k.jpg K212701 - Eminent Spine 3D Cervical Interbody Fusion System K212701 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Eminent Spine. Cleared Feb 2023. https://www.510kdatabase.net/k221531/ 2023-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k221531-clottriever-thrombectomy-system-fda-510k.jpg K221531 - ClotTriever Thrombectomy System K221531 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inari Medical, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k221980/ 2023-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k221980-disposable-powder-free-vinyl-fda-510k.jpg K221980 - Disposable Powder Free Vinyl Examination Gloves, Beige/Clear K221980 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ever Global (Vietnam) Enterprise Corporation. Cleared Feb 2023. https://www.510kdatabase.net/k222398/ 2023-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k222398-care-team-portal-fda-510k.jpg K222398 - Care Team Portal K222398 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vivify Health, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k222955/ 2023-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k222955-xenta-drug-screen-cup-xenta-drug-fda-510k.jpg K222955 - Xenta Drug Screen Cup, Xenta Drug Screen Dipcard K222955 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Xenta Biomedical Science Co., Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k223169/ 2023-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k223169-nerivio-fda-510k.jpg K223169 - Nerivio K223169 is a FDA 510(k) cleared neurology medical device. Manufacturer: Theranica Bioelectronics , Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k223296/ 2023-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k223296-videa-perio-assist-fda-510k.jpg K223296 - Videa Perio Assist K223296 is a FDA 510(k) cleared radiology medical device. Manufacturer: Videahealth, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k223444/ 2023-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k223444-powder-free-blue-nitrile-examination-fda-510k.jpg K223444 - Powder Free Blue Nitrile Examination Glove K223444 is a FDA 510(k) cleared general hospital medical device. Manufacturer: S&S Glove Corporation. Cleared Feb 2023. https://www.510kdatabase.net/k223735/ 2023-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k223735-acuson-sequoia-diagnostic-ultrasound-fda-510k.jpg K223735 - ACUSON Sequoia Diagnostic Ultrasound System, ACUSON Sequoia Select Diagnostic Ultrasound System K223735 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k230095/ 2023-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k230095-scanx-swift-20-scanx-swift-view-20-fda-510k.jpg K230095 - ScanX Swift 2.0, ScanX Swift View 2.0 K230095 is a FDA 510(k) cleared radiology medical device. Manufacturer: Durr Dental SE. Cleared Feb 2023. https://www.510kdatabase.net/k230270/ 2023-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k230270-3m-vitcal-linerbase-fda-510k.jpg K230270 - 3M™ VitCal Liner/Base K230270 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Espe Dental Products. Cleared Feb 2023. https://www.510kdatabase.net/k222570/ 2023-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k222570-copal-knee-moulds-fda-510k.jpg K222570 - COPAL knee moulds K222570 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Heraeus Medical GmbH. Cleared Feb 2023. https://www.510kdatabase.net/k222574/ 2023-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k222574-simparo-anchor-line-fixation-system-fda-510k.jpg K222574 - Simparo Anchor Line Fixation System K222574 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Simparo, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k213954/ 2023-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k213954-biofire-spotfire-respiratory-r-panel-fda-510k.jpg K213954 - BIOFIRE SPOTFIRE Respiratory (R) Panel K213954 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Biofire Diagnostics. Cleared Feb 2023. https://www.510kdatabase.net/k220296/ 2023-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k220296-manta-ray-tdf-spacer-fda-510k.jpg K220296 - Manta Ray TDF Spacer K220296 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared Feb 2023. https://www.510kdatabase.net/k220337/ 2023-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k220337-gaiabone-bioabsorbable-bone-graft-fda-510k.jpg K220337 - GaiaBone Bioabsorbable Bone Graft K220337 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corliber (Shenzhen) Medical Device Co., Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k220996/ 2023-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k220996-duoblade-fda-510k.jpg K220996 - Duoblade K220996 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cnc Technologies. Cleared Feb 2023. https://www.510kdatabase.net/k221253/ 2023-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k221253-spotfire-rsp-positive-control-spotfire-fda-510k.jpg K221253 - SPOTFIRE RSP Positive Control, SPOTFIRE RSP Negative Control K221253 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Maine Molecular Quality Controls, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k221348/ 2023-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k221348-intellivue-patient-monitor-mx750-866471-fda-510k.jpg K221348 - IntelliVue Patient Monitor MX750 (866471) K221348 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Philips Medizin Systeme B?blingen GmbH. Cleared Feb 2023. https://www.510kdatabase.net/k221491/ 2023-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k221491-anivia-sg1000-pump-console-fda-510k.jpg K221491 - Anivia SG1000 Pump Console K221491 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Apmtd, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k222063/ 2023-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k222063-montage-settable-resorbable-bone-putty-fda-510k.jpg K222063 - MONTAGE Settable, Resorbable Bone Putty K222063 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthocon, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k222153/ 2023-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k222153-microlife-upper-arm-automatic-digital-fda-510k.jpg K222153 - Microlife Upper Arm Automatic Digital BPM, Model WatchBP Office Vascular (TWIN200 VSR) K222153 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Microlife Intellectual Property GmbH. Cleared Feb 2023. https://www.510kdatabase.net/k222950/ 2023-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k222950-acupebble-ox100-fda-510k.jpg K222950 - AcuPebble OX100 K222950 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Acurable Limited. Cleared Feb 2023. https://www.510kdatabase.net/k223026/ 2023-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k223026-nes-reprocessed-eagle-eye-platinum-rx-fda-510k.jpg K223026 - NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter K223026 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Northeast Scientific, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k223051/ 2023-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k223051-pre-formed-silicone-block-fda-510k.jpg K223051 - Pre-Formed Silicone Block K223051 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: International Medical Devices, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k223395/ 2023-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k223395-luna-dental-implant-system-fda-510k.jpg K223395 - Luna Dental Implant System K223395 is a FDA 510(k) cleared dental medical device. Manufacturer: Shinhung Mst Co., Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k223481/ 2023-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k223481-vitek-2-streptococcus-tetracycline-025-fda-510k.jpg K223481 - VITEK® 2 Streptococcus Tetracycline (<=0.25 - >=16 µg/mL) K223481 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k223648/ 2023-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k223648-cook-spectrum-2-mrc-central-venous-fda-510k.jpg K223648 - Cook® Spectrum® 2 MRC Central Venous Catheter K223648 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cook Advanced Technologies. Cleared Feb 2023. https://www.510kdatabase.net/k223679/ 2023-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k223679-access-amh-fda-510k.jpg K223679 - Access AMH K223679 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k223876/ 2023-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k223876-smr-shoulder-system-fda-510k.jpg K223876 - SMR Shoulder System K223876 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Lima Corporate S.P.A.. Cleared Feb 2023. https://www.510kdatabase.net/k230051/ 2023-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k230051-14f-isleeve-introducer-set-fda-510k.jpg K230051 - 14F iSLEEVE™ Introducer Set K230051 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Feb 2023. https://www.510kdatabase.net/k230059/ 2023-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k230059-digital-flat-panel-detector-fda-510k.jpg K230059 - Digital Flat Panel Detector K230059 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ray Imaging Technology (Haining) Limited. Cleared Feb 2023. https://www.510kdatabase.net/den220044/ 2023-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/den220044-active-anthrax-detecttm-plus-rapid-test-fda-510k.jpg DEN220044 - Active Anthrax DetectTM Plus Rapid Test DEN220044 is a FDA 510(k) cleared microbiology medical device. Manufacturer: InBios International, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k210751/ 2023-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k210751-seal-hemostatic-wound-spray-fda-510k.jpg K210751 - S.E.A.L. Hemostatic Wound Spray K210751 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bc3 Technologies, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k213545/ 2023-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k213545-steelco-vs-series-steam-sterilizers-fda-510k.jpg K213545 - Steelco VS Series Steam Sterilizers, models 262839, 262851, 262869 K213545 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Steelco S.P.A.. Cleared Feb 2023. https://www.510kdatabase.net/k220126/ 2023-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k220126-geonic-nasal-aspirator-geonic-nasal-fda-510k.jpg K220126 - Geonic Nasal Aspirator, Geonic Nasal Cleaner K220126 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Geon Corporation. Cleared Feb 2023. https://www.510kdatabase.net/k221356/ 2023-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k221356-wee-bell-fda-510k.jpg K221356 - Wee Bell K221356 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Wee Medical. Cleared Feb 2023. https://www.510kdatabase.net/k221515/ 2023-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k221515-stonesmart-connect-console-lithovue-fda-510k.jpg K221515 - StoneSmart Connect Console, LithoVue Elite Single Use Digital Flexible Ureteroscope Standard w/Pressure Monitoring, LithoVue Elite Single Use Digital Flexible Ureteroscope Reverse w/Pressure Monitoring K221515 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Feb 2023. https://www.510kdatabase.net/k221781/ 2023-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k221781-image-processing-unit-model-opto-fda-510k.jpg K221781 - Image Processing Unit, Model: OPTO-CAM104K, Camera Head, Model: OPTO-CHD104KH K221781 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Guangdong Optomedic Technologies, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k222211/ 2023-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k222211-implant-direct-dental-implant-systems-fda-510k.jpg K222211 - Implant Direct Dental Implant Systems Portfolio - MR Conditional K222211 is a FDA 510(k) cleared dental medical device. Manufacturer: Implant Direct Sybron Manufacturing, LLC. Cleared Feb 2023. https://www.510kdatabase.net/k222422/ 2023-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k222422-polaris-valve-electronic-reading-fda-510k.jpg K222422 - Polaris Valve Electronic Reading Instrument K222422 is a FDA 510(k) cleared neurology medical device. Manufacturer: Sophysa. Cleared Feb 2023. https://www.510kdatabase.net/k222671/ 2023-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k222671-deltascan-patch-fda-510k.jpg K222671 - DeltaScan Patch K222671 is a FDA 510(k) cleared neurology medical device. Manufacturer: Prolira B.V.. Cleared Feb 2023. https://www.510kdatabase.net/k222680/ 2023-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k222680-deltascan-monitor-fda-510k.jpg K222680 - DeltaScan Monitor K222680 is a FDA 510(k) cleared neurology medical device. Manufacturer: Prolira B.V.. Cleared Feb 2023. https://www.510kdatabase.net/k222803/ 2023-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k222803-oncospace-fda-510k.jpg K222803 - Oncospace K222803 is a FDA 510(k) cleared radiology medical device. Manufacturer: Oncospace, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k223284/ 2023-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k223284-sutureloc-implant-fda-510k.jpg K223284 - SutureLoc™ Implant K223284 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k223362/ 2023-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k223362-cervical-spine-truss-system-stand-fda-510k.jpg K223362 - Cervical Spine Truss System - Stand Alone (CSTS-SA) Interbody Fusion Device K223362 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 4Web Medical, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k223406/ 2023-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k223406-smartrelease-endoscopic-soft-tissue-fda-510k.jpg K223406 - SmartRelease Endoscopic Soft Tissue Release System K223406 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Microaire Surgical Instruments. Cleared Feb 2023. https://www.510kdatabase.net/k223627/ 2023-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k223627-preview-iii-anterior-cervical-plate-fda-510k.jpg K223627 - PreView-III™ Anterior Cervical Plate System K223627 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nexus Spine, LLC. Cleared Feb 2023. https://www.510kdatabase.net/k230012/ 2023-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k230012-atomica-planner-fda-510k.jpg K230012 - Atomica Planner K230012 is a FDA 510(k) cleared radiology medical device. Manufacturer: Atomica Technology, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k213480/ 2023-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k213480-31p1h-head-coil-23na1h-head-coil-13c1h-fda-510k.jpg K213480 - 31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil K213480 is a FDA 510(k) cleared radiology medical device. Manufacturer: Rapid Biomedical GmbH. Cleared Feb 2023. https://www.510kdatabase.net/k221168/ 2023-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k221168-tinnitogram-signal-generator-fda-510k.jpg K221168 - Tinnitogram Signal Generator K221168 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Goldenear Company, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k221943/ 2023-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k221943-embedmed-fda-510k.jpg K221943 - EmbedMed K221943 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 3D Lifeprints UK , Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k222751/ 2023-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k222751-led-light-therapy-device-kn-7000l-fda-510k.jpg K222751 - LED Light Therapy Device, KN-7000L K222751 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Xuzhou Kernel Medical Equipment Co., Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k222863/ 2023-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k222863-garment-electrodes-fda-510k.jpg K222863 - Garment Electrodes K222863 is a FDA 510(k) cleared neurology medical device. Manufacturer: Tone-A-Matic International, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k222970/ 2023-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k222970-lvivo-iqs-fda-510k.jpg K222970 - LVivo IQS K222970 is a FDA 510(k) cleared radiology medical device. Manufacturer: Dia Imaging Analysis, Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/k223330/ 2023-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k223330-certas-plus-programmable-valves-fda-510k.jpg K223330 - Certas Plus Programmable Valves K223330 is a FDA 510(k) cleared neurology medical device. Manufacturer: Integra Lifesciences Production Corporation. Cleared Feb 2023. https://www.510kdatabase.net/k223396/ 2023-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k223396-rapid-rvlv-fda-510k.jpg K223396 - Rapid RV/LV K223396 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ischemaview, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k230020/ 2023-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k230020-briefcase-fda-510k.jpg K230020 - BriefCase K230020 is a FDA 510(k) cleared radiology medical device. Manufacturer: Aidoc Medical , Ltd.. Cleared Feb 2023. https://www.510kdatabase.net/den220014/ 2023-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/den220014-reflexion-medical-radiotherapy-system-fda-510k.jpg DEN220014 - RefleXion Medical Radiotherapy System (RMRS) DEN220014 is a FDA 510(k) cleared radiology medical device. Manufacturer: Reflexion Medical, Inc.. Cleared Feb 2023. https://www.510kdatabase.net/k221200/ 2023-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k221200-xbody-go-usa-xbody-pro-usa-fda-510k.jpg K221200 - XBody Go USA, XBody Pro USA K221200 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Xbody Hungary Kft.. Cleared Jan 2023. https://www.510kdatabase.net/k223117/ 2023-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k223117-v-sperm-wash-fda-510k.jpg K223117 - V-SPERM WASH K223117 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Vitromed GmbH. Cleared Jan 2023. https://www.510kdatabase.net/k223351/ 2023-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k223351-naviswiss-knee-fda-510k.jpg K223351 - Naviswiss Knee K223351 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Naviswiss AG. Cleared Jan 2023. https://www.510kdatabase.net/k210112/ 2023-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k210112-xchange-device-xchange-system-fda-510k.jpg K210112 - XChange Device, XChange System K210112 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Pneuma Therapeutics, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k221532/ 2023-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k221532-phmb-wound-dressing-fda-510k.jpg K221532 - PHMB Wound Dressing K221532 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Winner Medical Co., Ltd.. Cleared Jan 2023. https://www.510kdatabase.net/k222567/ 2023-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k222567-playground-for-all-love-sesh-fda-510k.jpg K222567 - Playground For All Love Sesh K222567 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Playground For All. Cleared Jan 2023. https://www.510kdatabase.net/k223348/ 2023-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k223348-my3d-personalized-pelvic-reconstruction-fda-510k.jpg K223348 - My3D® Personalized Pelvic Reconstruction K223348 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Onkos Surgical, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k212684/ 2023-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k212684-brainview-qeeg-software-fda-510k.jpg K212684 - BrainView QEEG Software K212684 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medeia, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k203833/ 2023-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k203833-tacrolimus-assay-kit-fda-510k.jpg K203833 - Tacrolimus Assay Kit K203833 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Shanghai Genext Medical Technology Co., Ltd.. Cleared Jan 2023. https://www.510kdatabase.net/k210166/ 2023-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k210166-omnispec-ed1000-fda-510k.jpg K210166 - Omnispec ED1000 K210166 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Medispec, Ltd.. Cleared Jan 2023. https://www.510kdatabase.net/k211559/ 2023-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k211559-easystat-300-fda-510k.jpg K211559 - EasyStat 300 K211559 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Medica Corporation. Cleared Jan 2023. https://www.510kdatabase.net/k213059/ 2023-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k213059-tibia-and-fibula-system-fda-510k.jpg K213059 - Tibia and Fibula System K213059 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Auxein Medical Private Limited. Cleared Jan 2023. https://www.510kdatabase.net/k220803/ 2023-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k220803-vitek-2-ast-gram-positive-moxifloxacin-fda-510k.jpg K220803 - VITEK 2 AST-Gram Positive Moxifloxacin (=0.25 - =8 µg/ml), VITEK 2 AST-GP Moxifloxacin (=0.25 - =8 µg/mL), VITEK 2 AST-GP Moxifloxacin K220803 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k221306/ 2023-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k221306-soltive-pro-superpulsed-laser-soltive-fda-510k.jpg K221306 - SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE SuperPulsed Laser Fibers, and Accessories K221306 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Gyrus Acmi, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k221338/ 2023-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k221338-fp-airvo-3-fda-510k.jpg K221338 - F&P Airvo 3 K221338 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Fisher & Paykel Healthcare. Cleared Jan 2023. https://www.510kdatabase.net/k221551/ 2023-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k221551-fujifilm-endoscope-model-ei-740ds-fda-510k.jpg K221551 - FUJIFILM Endoscope Model EI-740D/S K221551 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fujifilm Corporaton. Cleared Jan 2023. https://www.510kdatabase.net/k221868/ 2023-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k221868-qoca-image-smart-cxr-image-processing-fda-510k.jpg K221868 - QOCA image Smart CXR Image Processing System K221868 is a FDA 510(k) cleared radiology medical device. Manufacturer: Quanta Computer, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k222664/ 2023-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k222664-simsize-fda-510k.jpg K222664 - Sim&Size K222664 is a FDA 510(k) cleared neurology medical device. Manufacturer: Sim&Cure. Cleared Jan 2023. https://www.510kdatabase.net/k222835/ 2023-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k222835-prophecy-preoperative-navigation-fda-510k.jpg K222835 - Prophecy Preoperative Navigation Alignment System K222835 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jan 2023. https://www.510kdatabase.net/k222901/ 2023-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k222901-eva15-insufflator-fda-510k.jpg K222901 - EVA15 insufflator K222901 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Palliare , Ltd.. Cleared Jan 2023. https://www.510kdatabase.net/k223016/ 2023-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k223016-bd-veritortm-system-for-rapid-fda-510k.jpg K223016 - BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit K223016 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd. Cleared Jan 2023. https://www.510kdatabase.net/k223090/ 2023-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k223090-gem-premier-chemstat-fda-510k.jpg K223090 - GEM Premier ChemSTAT K223090 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jan 2023. https://www.510kdatabase.net/k223254/ 2023-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k223254-c2-xplore-fda-510k.jpg K223254 - C2 Xplore K223254 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Inomed Medizintechnik GmbH. Cleared Jan 2023. https://www.510kdatabase.net/k223546/ 2023-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k223546-14hq721g-b-fda-510k.jpg K223546 - 14HQ721G-B K223546 is a FDA 510(k) cleared radiology medical device. Manufacturer: Lg Electronics.Inc. Cleared Jan 2023. https://www.510kdatabase.net/k223903/ 2023-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k223903-non-sterile-single-use-powder-free-fda-510k.jpg K223903 - Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SMALL SIZE (NGPF102) K223903 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Semperit Investments Asia Pte , Ltd.. Cleared Jan 2023. https://www.510kdatabase.net/k223927/ 2023-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k223927-360cas-fda-510k.jpg K223927 - 360CAS K223927 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Kico Knee Innovation Company Pty Limited. Cleared Jan 2023. https://www.510kdatabase.net/k220073/ 2023-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k220073-rmf-2000-fda-510k.jpg K220073 - RMF-2000 K220073 is a FDA 510(k) cleared radiology medical device. Manufacturer: DRTECH Corporation. Cleared Jan 2023. https://www.510kdatabase.net/k221424/ 2023-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k221424-sterile-surgical-powder-free-latex-glove-fda-510k.jpg K221424 - Sterile Surgical Powder Free Latex Glove K221424 is a FDA 510(k) cleared general hospital medical device. Manufacturer: New Era Medicare Sdn. Bhd.. Cleared Jan 2023. https://www.510kdatabase.net/k221619/ 2023-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k221619-echelon-oval-v62-mri-system-fda-510k.jpg K221619 - ECHELON Oval V6.2 MRI System K221619 is a FDA 510(k) cleared radiology medical device. Manufacturer: Fujifilm Healthcare Corporation. Cleared Jan 2023. https://www.510kdatabase.net/k221949/ 2023-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k221949-ortho-device-adaptix-3d-orthopedic-fda-510k.jpg K221949 - Ortho Device, ADAPTIX 3D Orthopedic Imaging System K221949 is a FDA 510(k) cleared radiology medical device. Manufacturer: Pausch Medical GmbH. Cleared Jan 2023. https://www.510kdatabase.net/k222056/ 2023-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k222056-global-modular-replacement-system-fda-510k.jpg K222056 - Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee K222056 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp., Dba Stryker Orthopaedics. Cleared Jan 2023. https://www.510kdatabase.net/k222403/ 2023-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k222403-surgical-gown-fda-510k.jpg K222403 - Surgical Gown K222403 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guangzhou Fuzelong Hygiene Material Co., Ltd.. Cleared Jan 2023. https://www.510kdatabase.net/k222437/ 2023-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k222437-aristotle-colossus-guidewire-fda-510k.jpg K222437 - Aristotle Colossus Guidewire K222437 is a FDA 510(k) cleared neurology medical device. Manufacturer: Scientia Vascular, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k222589/ 2023-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k222589-flexible-suturing-system-with-anchors-fda-510k.jpg K222589 - Flexible Suturing System with Anchors (FSSA) K222589 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Integrity Orthopaedics, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k222779/ 2023-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k222779-revogene-fda-510k.jpg K222779 - Revogene K222779 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Meridian Bioscience, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k223415/ 2023-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k223415-nitrile-powder-free-blue-patient-fda-510k.jpg K223415 - Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate K223415 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Mah Sing Healthcare Sdn. Bhd.. Cleared Jan 2023. https://www.510kdatabase.net/k223588/ 2023-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k223588-pallas-premium-fda-510k.jpg K223588 - PALLAS Premium K223588 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Laseroptek Co., Ltd.. Cleared Jan 2023. https://www.510kdatabase.net/k220114/ 2023-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k220114-powerpak-syringe-fda-510k.jpg K220114 - PowerPAK Syringe K220114 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Vault Paragon Group, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k221150/ 2023-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k221150-advanced-bone-plate-fda-510k.jpg K221150 - Advanced Bone Plate K221150 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Double Medical Technology, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k222665/ 2023-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k222665-medline-unite-ankle-fusion-plating-fda-510k.jpg K222665 - Medline UNITE® Ankle Fusion Plating System K222665 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medline Industries, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k222801/ 2023-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k222801-safety-lancet-fda-510k.jpg K222801 - Safety Lancet K222801 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sarstedt AG & CO KG. Cleared Jan 2023. https://www.510kdatabase.net/k223306/ 2023-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k223306-sprint-peripheral-nerve-stimulation-fda-510k.jpg K223306 - SPRINT Peripheral Nerve Stimulation (PNS) System K223306 is a FDA 510(k) cleared neurology medical device. Manufacturer: Spr Therapeutics, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k223314/ 2023-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k223314-disposable-blood-lancets-fda-510k.jpg K223314 - Disposable Blood Lancets K223314 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Huaian Hening Medical Instruments Co., Ltd.. Cleared Jan 2023. https://www.510kdatabase.net/k223563/ 2023-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k223563-osteocnx-fda-510k.jpg K223563 - OsteoCNX K223563 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Converg Engineering. Cleared Jan 2023. https://www.510kdatabase.net/k223847/ 2023-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k223847-creed-cannulated-screws-fda-510k.jpg K223847 - CREED™ Cannulated Screws K223847 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Glw, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k223866/ 2023-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k223866-carevix-suction-cervical-stabilizer-fda-510k.jpg K223866 - Carevix™ Suction Cervical Stabilizer K223866 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Aspivix SA. Cleared Jan 2023. https://www.510kdatabase.net/k222818/ 2023-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k222818-xpedition-powered-stair-chair-fda-510k.jpg K222818 - Xpedition ™ Powered Stair Chair (625700000000) K222818 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Stryker Medical. Cleared Jan 2023. https://www.510kdatabase.net/k222879/ 2023-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k222879-transcutaneous-electrical-nerve-fda-510k.jpg K222879 - Transcutaneous Electrical Nerve Stimulator (model: TENS WMPS6-1) K222879 is a FDA 510(k) cleared neurology medical device. Manufacturer: Wuxi Jiajian Medical Instrument Co., Ltd.. Cleared Jan 2023. https://www.510kdatabase.net/k203689/ 2023-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k203689-tidepool-loop-fda-510k.jpg K203689 - Tidepool Loop K203689 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Tidepool Project. Cleared Jan 2023. https://www.510kdatabase.net/k221494/ 2023-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k221494-quality-mix-blender-oxymixer-fda-510k.jpg K221494 - Quality Mix Blender, Oxymixer K221494 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Dehas Medical Systems GmbH. Cleared Jan 2023. https://www.510kdatabase.net/k222406/ 2023-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k222406-clarius-ai-fda-510k.jpg K222406 - Clarius AI K222406 is a FDA 510(k) cleared radiology medical device. Manufacturer: Clarius Mobile Health Corp.. Cleared Jan 2023. https://www.510kdatabase.net/k223158/ 2023-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k223158-ligasure-xp-maryland-jaw-sealerdivider-fda-510k.jpg K223158 - LigaSure™ XP Maryland Jaw Sealer/Divider K223158 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien, LLC. Cleared Jan 2023. https://www.510kdatabase.net/k223313/ 2023-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k223313-disposable-safety-lancets-fda-510k.jpg K223313 - Disposable Safety Lancets K223313 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Huaian Hening Medical Instruments Co., Ltd.. Cleared Jan 2023. https://www.510kdatabase.net/k223494/ 2023-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k223494-cd-horizon-spinal-system-fda-510k.jpg K223494 - CD Horizon Spinal System K223494 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic. Cleared Jan 2023. https://www.510kdatabase.net/k222531/ 2023-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k222531-synthetic-polymer-glove-polyethylene-fda-510k.jpg K222531 - Synthetic Polymer Glove - Polyethylene (Black) K222531 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ur Industry Sdn Bhd. Cleared Jan 2023. https://www.510kdatabase.net/k222832/ 2023-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k222832-sentimag-system-fda-510k.jpg K222832 - Sentimag System K222832 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Endomagnetics Ltd.,. Cleared Jan 2023. https://www.510kdatabase.net/k223118/ 2023-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k223118-oic-variable-angle-small-fragment-fda-510k.jpg K223118 - OIC Variable Angle Small Fragment Locking Plate System K223118 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthopaedic Implant Company. Cleared Jan 2023. https://www.510kdatabase.net/k223516/ 2023-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k223516-vx1-fda-510k.jpg K223516 - VX1+ K223516 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Volta Medical. Cleared Jan 2023. https://www.510kdatabase.net/k203792/ 2023-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k203792-insupen-pen-needle-insupen-original-fda-510k.jpg K203792 - Insupen Pen needle, Insupen ORIGINAL Pen Needle, Insupen ADVANCED pen needle K203792 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Pikdare Spa. Cleared Jan 2023. https://www.510kdatabase.net/k214077/ 2023-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k214077-digital-thermometer-model-dt007-dt008-fda-510k.jpg K214077 - Digital Thermometer, Model: DT007, DT008 K214077 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guangzhou Berrcom Medical Device Co., Ltd.. Cleared Jan 2023. https://www.510kdatabase.net/k221419/ 2023-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k221419-td-5010-lancing-device-and-td-5084-fda-510k.jpg K221419 - TD-5010 Lancing Device and TD-5084 Sterile Lancets K221419 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Gostar Co., Ltd.. Cleared Jan 2023. https://www.510kdatabase.net/k221683/ 2023-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k221683-cysto-nephro-videoscope-olympus-cyf-v2-fda-510k.jpg K221683 - CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-V2R), CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VH) and CYSTO-NEPHRO VIDEOSCOPE (OLYMPUS CYF-VHR) K221683 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Medical Systems Corporation. Cleared Jan 2023. https://www.510kdatabase.net/k221725/ 2023-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k221725-advanced-myhip-planner-fda-510k.jpg K221725 - Advanced MyHip Planner K221725 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medacta International S.A.. Cleared Jan 2023. https://www.510kdatabase.net/k221899/ 2023-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k221899-the-sensititre-yeastone-susceptibility-fda-510k.jpg K221899 - The Sensititre YeastOne Susceptibility System with Caspofungin in the dilution range of 0.015-16ug/ml K221899 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Thermo Fisher Scientific. Cleared Jan 2023. https://www.510kdatabase.net/k222158/ 2023-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k222158-capiflo-5001-fda-510k.jpg K222158 - Capiflo 5001 K222158 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: K&L Distributing, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k222462/ 2023-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k222462-semi-automatic-biopsy-needle-bim-1820-fda-510k.jpg K222462 - Semi-automatic Biopsy-Needle (BIM 18/20) K222462 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Itp Innovative Tomography Products GmbH. Cleared Jan 2023. https://www.510kdatabase.net/k222510/ 2023-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k222510-blueprint-mixed-reality-system-fda-510k.jpg K222510 - Blueprint Mixed Reality system K222510 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tornier S.A.S.. Cleared Jan 2023. https://www.510kdatabase.net/k222848/ 2023-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k222848-preset-thrombectomy-device-fda-510k.jpg K222848 - pRESET Thrombectomy Device K222848 is a FDA 510(k) cleared neurology medical device. Manufacturer: Phenox Limited. Cleared Jan 2023. https://www.510kdatabase.net/k222889/ 2023-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k222889-flowart-needle-free-split-septum-valve-fda-510k.jpg K222889 - FlowArt® Needle-Free Split Septum Valve K222889 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Asset Medikal Tasarim San Tic As.. Cleared Jan 2023. https://www.510kdatabase.net/k223177/ 2023-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k223177-highlander-014-pta-balloon-dilatation-fda-510k.jpg K223177 - Highlander™ 014 PTA Balloon Dilatation Catheter K223177 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k223404/ 2023-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k223404-duetto-suprema-fda-510k.jpg K223404 - Duetto Suprema K223404 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Quanta System Spa. Cleared Jan 2023. https://www.510kdatabase.net/k223521/ 2023-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k223521-zespin-si-joint-fusion-system-fda-510k.jpg K223521 - ZESPIN SI Joint Fusion System K223521 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aegis Spine, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k223528/ 2023-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k223528-triathlon-hinge-knee-system-fda-510k.jpg K223528 - Triathlon® Hinge Knee System K223528 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp., Dba Stryker Orthopaedics. Cleared Jan 2023. https://www.510kdatabase.net/k223548/ 2023-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k223548-gmk-sphere-gmk-spherika-cementless-fda-510k.jpg K223548 - GMK Sphere & GMK SpheriKA Cementless K223548 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Jan 2023. https://www.510kdatabase.net/k223842/ 2023-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k223842-drx-compass-fda-510k.jpg K223842 - DRX - Compass K223842 is a FDA 510(k) cleared radiology medical device. Manufacturer: Carestream Health, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k211197/ 2023-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k211197-disposable-endoscopic-cutter-stapler-fda-510k.jpg K211197 - Disposable Endoscopic Cutter Stapler and Cartridge K211197 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Changzhou Waston Medical Appliance Co., Ltd.. Cleared Jan 2023. https://www.510kdatabase.net/k213175/ 2023-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k213175-no-stress-impress-fda-510k.jpg K213175 - No Stress Impress K213175 is a FDA 510(k) cleared dental medical device. Manufacturer: No Stress Impress, LLC. Cleared Jan 2023. https://www.510kdatabase.net/k213772/ 2023-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k213772-lm-9300-plus-lithotripter-fda-510k.jpg K213772 - LM-9300 Plus Lithotripter K213772 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Lite-Med, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k220059/ 2023-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k220059-biosci-inactivated-transport-medium-fda-510k.jpg K220059 - Biosci™ Inactivated Transport Medium, Biosci™ ITM K220059 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Shenzhen Dakewe Bio-Engineering Co., Ltd.. Cleared Jan 2023. https://www.510kdatabase.net/k220448/ 2023-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k220448-disposable-non-invasive-eeg-sensor-fda-510k.jpg K220448 - Disposable Non-invasive EEG Sensor K220448 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Med-Link Electronics Tech Co., Ltd.. Cleared Jan 2023. https://www.510kdatabase.net/k221163/ 2023-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k221163-tunnel-crossing-catheter-fda-510k.jpg K221163 - Tunnel Crossing Catheter K221163 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Tractus Vascular, LLC. Cleared Jan 2023. https://www.510kdatabase.net/k221522/ 2023-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k221522-hf-cables-resusable-fda-510k.jpg K221522 - HF-cables (resusable) K221522 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Winter & Ibe GmbH. Cleared Jan 2023. https://www.510kdatabase.net/k221627/ 2023-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k221627-perfusiongo-plus-fda-510k.jpg K221627 - PerfusionGo Plus K221627 is a FDA 510(k) cleared radiology medical device. Manufacturer: Yukun (Beijing) Technology Co., Ltd.. Cleared Jan 2023. https://www.510kdatabase.net/k222252/ 2023-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k222252-self-adhesive-electrode-fda-510k.jpg K222252 - Self-adhesive Electrode K222252 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Roundwhale Technology Co. , Ltd.. Cleared Jan 2023. https://www.510kdatabase.net/k222554/ 2023-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k222554-el-capitan-anterior-lumbar-interbody-fda-510k.jpg K222554 - EL CAPITAN Anterior Lumbar Interbody Fusion K222554 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Astura Medical. Cleared Jan 2023. https://www.510kdatabase.net/k223108/ 2023-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k223108-teligen-system-navigation-ready-fda-510k.jpg K223108 - TELIGEN System Navigation Ready Indications (TELIGEN Access Probe, TELIGEN Clear) K223108 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International SARL. Cleared Jan 2023. https://www.510kdatabase.net/k223166/ 2023-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k223166-medaica-m1-telehealth-stethoscope-fda-510k.jpg K223166 - Medaica M1 Telehealth Stethoscope K223166 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medaica, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k223250/ 2023-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k223250-disposable-nitrile-examination-glove-fda-510k.jpg K223250 - Disposable Nitrile Examination Glove K223250 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Yangzhou Saraguard Medical Supplies Co., Ltd.. Cleared Jan 2023. https://www.510kdatabase.net/k223503/ 2023-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k223503-access-25oh-vitamin-d-total-fda-510k.jpg K223503 - Access 25(OH) Vitamin D Total K223503 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k223540/ 2023-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k223540-avalanchelase-family-fda-510k.jpg K223540 - AvalancheLase Family K223540 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Fotona D.O.O.. Cleared Jan 2023. https://www.510kdatabase.net/k223872/ 2023-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k223872-low-profile-companion-sheath-fda-510k.jpg K223872 - Low Profile Companion Sheath K223872 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k211759/ 2023-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k211759-selux-ast-system-fda-510k.jpg K211759 - Selux AST System K211759 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Selux Diagnostics, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k213597/ 2023-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k213597-multicut-solo-fda-510k.jpg K213597 - MultiCut Solo K213597 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Asclepion Laser Technologies GmbH. Cleared Jan 2023. https://www.510kdatabase.net/k221088/ 2023-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k221088-anatomic-bone-plate-fda-510k.jpg K221088 - Anatomic Bone Plate K221088 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Double Medical Technology, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k221726/ 2023-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k221726-uni-fuze-c-bone-strip-fda-510k.jpg K221726 - Uni-FuZe-C Bone Strip K221726 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zavation Medical Products, LLC. Cleared Jan 2023. https://www.510kdatabase.net/k222000/ 2023-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k222000-transit-pellets-fda-510k.jpg K222000 - Transit-Pellets K222000 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medifactia AB. Cleared Jan 2023. https://www.510kdatabase.net/k222593/ 2023-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k222593-truplan-computed-tomography-ct-imaging-fda-510k.jpg K222593 - TruPlan Computed Tomography (CT) Imaging Software K222593 is a FDA 510(k) cleared radiology medical device. Manufacturer: Circle Cardiovascular Imaging, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k223107/ 2023-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k223107-molli-2-fda-510k.jpg K223107 - MOLLI 2 K223107 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Molli Surgical, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k223446/ 2023-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k223446-exciteosa-without-remote-control-3000-fda-510k.jpg K223446 - eXciteOSA without remote control (3000) K223446 is a FDA 510(k) cleared dental medical device. Manufacturer: Signifier Medical Technologies, Ltd.. Cleared Jan 2023. https://www.510kdatabase.net/k223804/ 2023-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k223804-percunav-image-fusion-and-fda-510k.jpg K223804 - PercuNav Image Fusion and Interventional Navigation System K223804 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Ultrasound, LLC. Cleared Jan 2023. https://www.510kdatabase.net/k223819/ 2023-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k223819-si-cure-sacroiliac-joint-fusion-system-fda-510k.jpg K223819 - SI-Cure Sacroiliac Joint Fusion System K223819 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alevio, LLC. Cleared Jan 2023. https://www.510kdatabase.net/k213655/ 2023-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k213655-hitop-models-hitop4touch-hitop2touch-fda-510k.jpg K213655 - HiTop® (Models: HiToP®4touch, HiToP®2touch, HiToP®1touch) K213655 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Hilltek, LLC. Cleared Jan 2023. https://www.510kdatabase.net/k220649/ 2023-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k220649-elucis-fda-510k.jpg K220649 - Elucis K220649 is a FDA 510(k) cleared radiology medical device. Manufacturer: Realize Medical, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k220884/ 2023-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k220884-disposable-endoscope-valve-sets-fda-510k.jpg K220884 - Disposable Endoscope Valve Sets K220884 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Sml Med-Tech Solutions Limited. Cleared Jan 2023. https://www.510kdatabase.net/k221754/ 2023-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k221754-ag-foam-dressing-non-adhesive-otc-fda-510k.jpg K221754 - Ag Foam Dressing Non-Adhesive (OTC) K221754 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Winner Medical Co., Ltd.. Cleared Jan 2023. https://www.510kdatabase.net/k222941/ 2023-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k222941-halcyon-ethos-radiotherapy-system-fda-510k.jpg K222941 - Halcyon, Ethos Radiotherapy System K222941 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k223010/ 2023-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k223010-portable-x-ray-system-fda-510k.jpg K223010 - Portable X-ray System K223010 is a FDA 510(k) cleared radiology medical device. Manufacturer: Iray Technology Taicang , Ltd.. Cleared Jan 2023. https://www.510kdatabase.net/k223222/ 2023-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k223222-plasma-iq-fda-510k.jpg K223222 - Plasma IQ K223222 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Neauvia North America, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k223794/ 2023-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k223794-hyperion-x9-pro-newtom-giano-hr-x-fda-510k.jpg K223794 - hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS K223794 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cefla S.C.. Cleared Jan 2023. https://www.510kdatabase.net/k223795/ 2023-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k223795-fairfix-qt-adjustable-button-fda-510k.jpg K223795 - FairFix QT Adjustable Button K223795 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Jan 2023. https://www.510kdatabase.net/k223800/ 2023-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k223800-mim-additional-tracers-fda-510k.jpg K223800 - MIM – Additional Tracers K223800 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mim Software, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k213514/ 2023-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k213514-spectricept-skin-and-wound-cleanser-fda-510k.jpg K213514 - Spectricept Skin and Wound Cleanser K213514 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Spectrum Antimicrobials, Inc. (Subsidiary of Collidion, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k214078/ 2023-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k214078-silkn-toothwave-fda-510k.jpg K214078 - Silk’n Toothwave K214078 is a FDA 510(k) cleared dental medical device. Manufacturer: Home Skinovations , Ltd.. Cleared Jan 2023. https://www.510kdatabase.net/k220495/ 2023-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k220495-signasure-dual-mobility-system-fda-510k.jpg K220495 - SignaSure Dual Mobility System K220495 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Signature Orthopaedics Pty, Ltd.. Cleared Jan 2023. https://www.510kdatabase.net/k221020/ 2023-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k221020-accuryn-monitoring-system-accuryn-fda-510k.jpg K221020 - Accuryn Monitoring System, Accuryn SmartFoley IAP UO Temp Tray System 12 F, Accuryn SmartFoley IAP UO Temp Tray System 14 F K221020 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Potrero Medical, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k221252/ 2023-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k221252-scivita-4kinsight-icg-imaging-system-fda-510k.jpg K221252 - Scivita 4KINSIGHT ICG Imaging System K221252 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Scivita Medical Technology Co., Ltd.. Cleared Jan 2023. https://www.510kdatabase.net/k221317/ 2023-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k221317-s-mono-fda-510k.jpg K221317 - S-Mono K221317 is a FDA 510(k) cleared dental medical device. Manufacturer: Shinhung Mst Co., Ltd.. Cleared Jan 2023. https://www.510kdatabase.net/k221542/ 2023-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k221542-galileo-vertebral-body-replacement-fda-510k.jpg K221542 - Galileo Vertebral Body Replacement Device K221542 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Bright Spine. Cleared Jan 2023. https://www.510kdatabase.net/k221682/ 2023-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k221682-ideal-med-pro-3-ply-disposable-face-mask-fda-510k.jpg K221682 - Ideal Med Pro 3-Ply Disposable Face Mask K221682 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jsn Holdings, LLC. Cleared Jan 2023. https://www.510kdatabase.net/k221755/ 2023-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k221755-antimicrobial-gauze-sponge-dressing-fda-510k.jpg K221755 - Antimicrobial gauze sponge dressing K221755 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Winner Medical Co., Ltd.. Cleared Jan 2023. https://www.510kdatabase.net/k221933/ 2023-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k221933-montage-settable-resorbable-bone-putty-fda-510k.jpg K221933 - MONTAGE Settable, Resorbable Bone Putty K221933 is a FDA 510(k) cleared neurology medical device. Manufacturer: Orthocon, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k222170/ 2023-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k222170-power-acute-triple-lumen-hemodialysis-fda-510k.jpg K222170 - Power Acute Triple Lumen Hemodialysis Catheter K222170 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Health Line International Corporation. Cleared Jan 2023. https://www.510kdatabase.net/k222171/ 2023-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k222171-magstim-horizon-30-tms-therapy-system-fda-510k.jpg K222171 - Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+ K222171 is a FDA 510(k) cleared neurology medical device. Manufacturer: Magstim Company, Ltd.. Cleared Jan 2023. https://www.510kdatabase.net/k222782/ 2023-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k222782-wearable-breast-pump-modelyd-1193yd-fda-510k.jpg K222782 - Wearable Breast Pump (Model:YD-1193,YD-1195,YD-1196,YD-1198,YD-1199 K222782 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Zhejiang Carebao Co., Ltd.. Cleared Jan 2023. https://www.510kdatabase.net/k222913/ 2023-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k222913-s-clean-link-abutment-fda-510k.jpg K222913 - s-Clean Link Abutment K222913 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentis Co., Ltd.. Cleared Jan 2023. https://www.510kdatabase.net/k223031/ 2023-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k223031-vibrant-system-fda-510k.jpg K223031 - Vibrant System K223031 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Vibrant, Ltd.. Cleared Jan 2023. https://www.510kdatabase.net/k223183/ 2023-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k223183-light-guide-cables-fda-510k.jpg K223183 - Light-Guide Cables K223183 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Olympus Winter & Ibe GmbH. Cleared Jan 2023. https://www.510kdatabase.net/k223221/ 2023-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k223221-non-sterile-powder-free-nitrile-fda-510k.jpg K223221 - Non-Sterile Powder Free Nitrile Examination Gloves K223221 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Dynacare Sdn Bhd. Cleared Jan 2023. https://www.510kdatabase.net/k223405/ 2023-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k223405-access-testosterone-fda-510k.jpg K223405 - Access Testosterone K223405 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k223429/ 2023-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k223429-contour-knee-fda-510k.jpg K223429 - Contour Knee K223429 is a FDA 510(k) cleared radiology medical device. Manufacturer: Quality Electrodynamics, LLC. Cleared Jan 2023. https://www.510kdatabase.net/k223474/ 2023-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k223474-pathloc-ta-expandable-lumbar-cage-system-fda-510k.jpg K223474 - PathLoc-TA Expandable Lumbar Cage System K223474 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: L & K Biomed Co., Ltd.. Cleared Jan 2023. https://www.510kdatabase.net/k223480/ 2023-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k223480-medipoint-blood-lancets-fda-510k.jpg K223480 - Medipoint Blood Lancets K223480 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medipoint Holdings, LLC. Cleared Jan 2023. https://www.510kdatabase.net/k223502/ 2023-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k223502-mr-diffusion-perfusion-mismatch-v10-fda-510k.jpg K223502 - MR Diffusion Perfusion Mismatch V1.0 K223502 is a FDA 510(k) cleared radiology medical device. Manufacturer: Olea Medical. Cleared Jan 2023. https://www.510kdatabase.net/k223746/ 2023-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k223746-solex-7-intravascular-heat-exchange-fda-510k.jpg K223746 - Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard XP Console, Thermogard HQ Console K223746 is a FDA 510(k) cleared neurology medical device. Manufacturer: Zoll Circulation, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k223748/ 2023-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k223748-nitrile-exam-gloves-chemotherapy-drug-fda-510k.jpg K223748 - Nitrile Exam Gloves (Chemotherapy Drug Tested) K223748 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Us Medical Glove Company, LLC. Cleared Jan 2023. https://www.510kdatabase.net/k221774/ 2023-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k221774-garmin-ecg-app-fda-510k.jpg K221774 - Garmin ECG App K221774 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Garmin International, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k221873/ 2023-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k221873-neogen-psr-system-fda-510k.jpg K221873 - NeoGen PSR System K221873 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Energist Limited. Cleared Jan 2023. https://www.510kdatabase.net/k222011/ 2023-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k222011-handx-instrument-monopolar-spatula-fda-510k.jpg K222011 - HandX Instrument - Monopolar Spatula K222011 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Human Xtensions , Ltd.. Cleared Jan 2023. https://www.510kdatabase.net/k222150/ 2023-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k222150-prexion3d-expedition-fda-510k.jpg K222150 - PreXion3D Expedition K222150 is a FDA 510(k) cleared radiology medical device. Manufacturer: Prexion Corporation. Cleared Jan 2023. https://www.510kdatabase.net/k222458/ 2023-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k222458-aibolit-3d-fda-510k.jpg K222458 - AIBOLIT 3D+ K222458 is a FDA 510(k) cleared radiology medical device. Manufacturer: Aibolit Technologies, LLC. Cleared Jan 2023. https://www.510kdatabase.net/k222830/ 2023-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k222830-rainbow-360-fda-510k.jpg K222830 - Rainbow 360 K222830 is a FDA 510(k) cleared dental medical device. Manufacturer: Kerr Corporation. Cleared Jan 2023. https://www.510kdatabase.net/k222976/ 2023-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k222976-mu-system-fda-510k.jpg K222976 - MU System K222976 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentis Co., Ltd.. Cleared Jan 2023. https://www.510kdatabase.net/k223363/ 2023-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k223363-mammovista-bsmart-vb70-fda-510k.jpg K223363 - MAMMOVISTA B.smart (VB70) K223363 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k223644/ 2023-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k223644-neuronaute-with-icecap-2-icecap-2-small-fda-510k.jpg K223644 - Neuronaute with IceCap 2 & IceCap 2 Small K223644 is a FDA 510(k) cleared neurology medical device. Manufacturer: Bioserenity. Cleared Jan 2023. https://www.510kdatabase.net/k223731/ 2023-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k223731-nuvasive-modulus-c-interbody-system-fda-510k.jpg K223731 - NuVasive Modulus-C Interbody System K223731 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nuvasive, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k223782/ 2023-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k223782-ambu-ascope-5-broncho-hd-5628-sampler-fda-510k.jpg K223782 - Ambu aScope 5 Broncho HD 5.6/2.8 Sampler Set, Ambu aScope 5 Broncho HD 5.0/2.2 Sampler Set K223782 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Ambu A/S. Cleared Jan 2023. https://www.510kdatabase.net/k191111/ 2023-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k191111-dd-solid-connect-cadcam-abutments-fda-510k.jpg K191111 - DD Solid Connect® CAD/CAM Abutments K191111 is a FDA 510(k) cleared dental medical device. Manufacturer: Dental Direkt GmbH. Cleared Jan 2023. https://www.510kdatabase.net/k221278/ 2023-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k221278-transducer-probe-cover-fda-510k.jpg K221278 - Transducer Probe Cover K221278 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hony Medical Co., Ltd.. Cleared Jan 2023. https://www.510kdatabase.net/k222181/ 2023-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k222181-iconic-blue-nitrile-glove-tested-for-fda-510k.jpg K222181 - Iconic Blue Nitrile Glove - Tested for use with Chemotherapy Drugs & Fentanyl Citrate K222181 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Iconic Medicare Sdn Bhd. Cleared Jan 2023. https://www.510kdatabase.net/k223000/ 2023-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k223000-artix-bg-fda-510k.jpg K223000 - Artix BG K223000 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inari Medical. Cleared Jan 2023. https://www.510kdatabase.net/k223181/ 2023-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k223181-nuvasive-reline-system-fda-510k.jpg K223181 - NuVasive Reline System K223181 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Jan 2023. https://www.510kdatabase.net/k223295/ 2023-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k223295-endoscope-model-en-580t-over-tube-ts-fda-510k.jpg K223295 - Endoscope Model EN-580T, Over-tube TS-1314B, Balloon BS-4, Tube Kit TY-500D K223295 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fujifilm Corporaton. Cleared Jan 2023. https://www.510kdatabase.net/k223465/ 2023-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k223465-radiancetx-radionuclide-brachytherapy-fda-510k.jpg K223465 - RadianceTx Radionuclide Brachytherapy Source K223465 is a FDA 510(k) cleared radiology medical device. Manufacturer: Radiance Therapeutics, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k223719/ 2023-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k223719-paeon-anterior-cervical-plate-system-fda-510k.jpg K223719 - Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System K223719 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aegis Spine, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k223738/ 2023-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k223738-alpha-control-liner-system-acls-fda-510k.jpg K223738 - Alpha Control Liner System (ACLS) K223738 is a FDA 510(k) cleared neurology medical device. Manufacturer: Coapt. Cleared Jan 2023. https://www.510kdatabase.net/k223764/ 2023-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k223764-infinity-oct-system-fda-510k.jpg K223764 - INFINITY OCT System K223764 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k223931/ 2023-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k223931-dexcom-g6-continuous-glucose-fda-510k.jpg K223931 - Dexcom G6 Continuous Glucose Monitoring (CGM) System K223931 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dexcom, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k211047/ 2023-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k211047-cocr-head-fda-510k.jpg K211047 - CoCr Head K211047 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer GmbH. Cleared Jan 2023. https://www.510kdatabase.net/k221090/ 2023-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k221090-metal-cannulated-screw-fda-510k.jpg K221090 - Metal Cannulated Screw K221090 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Double Medical Technology, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k222115/ 2023-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k222115-isaac-neurovascular-navigation-catheter-fda-510k.jpg K222115 - ISAAC Neurovascular Navigation Catheter K222115 is a FDA 510(k) cleared neurology medical device. Manufacturer: MicroVention, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k222799/ 2023-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k222799-haymaker-screw-system-fda-510k.jpg K222799 - Haymaker® Screw System K222799 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthocircle Spine D.B.A. OC Medical Devices. Cleared Jan 2023. https://www.510kdatabase.net/k211163/ 2023-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k211163-bone-cement-genta-bone-cement-hv-bone-fda-510k.jpg K211163 - Bone Cement Genta, Bone Cement HV, Bone Cement LV K211163 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tecres S.P.A.. Cleared Jan 2023. https://www.510kdatabase.net/k222711/ 2023-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k222711-hs186b-scooter-fda-510k.jpg K222711 - HS186B Scooter K222711 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Suzhou Master Machinery Manufacturing Co.,Ltd. Cleared Jan 2023. https://www.510kdatabase.net/k222787/ 2023-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k222787-sunkingdom-ophthalmic-ultrasound-fda-510k.jpg K222787 - Sunkingdom Ophthalmic Ultrasound Examination Instrument SK-3000A, SK-3000B, SK-3000C, SK-2000AP, SK-2000A, SK-2000P K222787 is a FDA 510(k) cleared radiology medical device. Manufacturer: Chongqing Sunkingdom Medical Instrument Co., Ltd.. Cleared Jan 2023. https://www.510kdatabase.net/k222789/ 2023-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k222789-vader-pedicle-system-g21-cement-fda-510k.jpg K222789 - VADER® Pedicle System, G21 Cement K222789 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Icotec AG. Cleared Jan 2023. https://www.510kdatabase.net/k223336/ 2023-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k223336-vitrea-software-package-vstp-002a-fda-510k.jpg K223336 - Vitrea Software Package, VSTP-002A K223336 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Jan 2023. https://www.510kdatabase.net/k223789/ 2023-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k223789-21hq513d-fda-510k.jpg K223789 - 21HQ513D K223789 is a FDA 510(k) cleared radiology medical device. Manufacturer: Lg Electronics.Inc. Cleared Jan 2023. https://www.510kdatabase.net/k203380/ 2023-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k203380-disposable-surgical-face-mask-fda-510k.jpg K203380 - Disposable Surgical Face Mask K203380 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shandong Pop Jeans Intelligent Manufacturing Co., Ltd.. Cleared Jan 2023. https://www.510kdatabase.net/k211812/ 2023-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k211812-bluediamond-implant-abutment-screw-fda-510k.jpg K211812 - BLUEDIAMOND IMPLANT, Abutment Screw K211812 is a FDA 510(k) cleared dental medical device. Manufacturer: Megagen Implant Co., Ltd.. Cleared Jan 2023. https://www.510kdatabase.net/k213423/ 2023-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k213423-t3-platform-software-fda-510k.jpg K213423 - T3 Platform software K213423 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Etiometry, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k221260/ 2023-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k221260-csf-3-fda-510k.jpg K221260 - CSF-3 K221260 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cardiacsense. Cleared Jan 2023. https://www.510kdatabase.net/k222296/ 2023-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k222296-articuleze-ceramic-heads-fda-510k.jpg K222296 - ARTICUL/EZE Ceramic Heads K222296 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Ireland UC. Cleared Jan 2023. https://www.510kdatabase.net/k222577/ 2023-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k222577-techfit-diagnostic-models-fda-510k.jpg K222577 - TECHFIT Diagnostic Models K222577 is a FDA 510(k) cleared radiology medical device. Manufacturer: Techfit Digital Surgery, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k223200/ 2023-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k223200-curiteva-navigation-system-fda-510k.jpg K223200 - Curiteva Navigation System K223200 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Curiteva, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k223412/ 2023-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k223412-lumivy-lumbar-ibf-system-fda-510k.jpg K223412 - LumiVy™ Lumbar IBF System K223412 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Vy Spine, LLC. Cleared Jan 2023. https://www.510kdatabase.net/k223675/ 2023-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k223675-watchpat-one-wp1-fda-510k.jpg K223675 - WatchPAT ONE (WP1) K223675 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Itamar Medical , Ltd.. Cleared Jan 2023. https://www.510kdatabase.net/k223749/ 2023-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k223749-u-by-kotex-click-unscented-menstrual-fda-510k.jpg K223749 - U by Kotex® Click® Unscented Menstrual Tampons K223749 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Kimberly Clark Corporation. Cleared Jan 2023. https://www.510kdatabase.net/k213198/ 2023-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k213198-ax-surgi-surgical-hemostat-fda-510k.jpg K213198 - Ax-Surgi Surgical Hemostat K213198 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Advamedica, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k221149/ 2023-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k221149-u-motion-ii-acetabular-system-fda-510k.jpg K221149 - U-Motion II Acetabular System-Extension line K221149 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: United Orthopedic Corporation. Cleared Jan 2023. https://www.510kdatabase.net/k221181/ 2023-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k221181-treace-medical-concepts-tmc-plating-fda-510k.jpg K221181 - Treace Medical Concepts (TMC) Plating System K221181 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Treace Medical Concepts, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k221266/ 2023-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k221266-cervical-spine-truss-system-csts-fda-510k.jpg K221266 - Cervical Spine Truss System (CSTS) Interbody Fusion Device K221266 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 4Web Medical, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k222834/ 2023-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k222834-safety-push-button-blood-collection-set-fda-510k.jpg K222834 - Safety Push Button Blood Collection Set K222834 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Caina Medical Co.,Ltd. Cleared Jan 2023. https://www.510kdatabase.net/k223650/ 2023-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k223650-remedy-stemmed-knee-spacer-fda-510k.jpg K223650 - REMEDY Stemmed Knee Spacer K223650 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteoremedies, LLC. Cleared Jan 2023. https://www.510kdatabase.net/k223671/ 2023-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k223671-conduit-llif-straight-inserters-fda-510k.jpg K223671 - CONDUIT LLIF Straight Inserters K223671 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Enztec Limited. Cleared Jan 2023. https://www.510kdatabase.net/k213263/ 2023-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k213263-onyxceph-fda-510k.jpg K213263 - OnyxCeph K213263 is a FDA 510(k) cleared dental medical device. Manufacturer: Image Instruments GmbH. Cleared Jan 2023. https://www.510kdatabase.net/k221125/ 2023-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k221125-silentcloud-fda-510k.jpg K221125 - SilentCloud K221125 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Aureliym GmbH. Cleared Jan 2023. https://www.510kdatabase.net/k221379/ 2023-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k221379-steriking-lt-blueline-pouches-with-tyvek-fda-510k.jpg K221379 - Steriking LT-Blueline Pouches with Tyvek K221379 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wipak OY. Cleared Jan 2023. https://www.510kdatabase.net/k221693/ 2023-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k221693-elecsys-anti-hcv-ii-08837031190-fda-510k.jpg K221693 - Elecsys Anti-HCV II (08837031190) K221693 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Diagnostics. Cleared Jan 2023. https://www.510kdatabase.net/k222045/ 2023-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k222045-wearable-breast-pump-model-s1dw-fda-510k.jpg K222045 - Wearable Breast Pump (Model S1DW) K222045 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shenzhen TPH Technology Co., Ltd.. Cleared Jan 2023. https://www.510kdatabase.net/k222182/ 2023-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k222182-radial-artery-compression-tourniquets-fda-510k.jpg K222182 - Radial Artery Compression Tourniquets K222182 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Beijing Demax Medical Technology Co.,Ltd. Cleared Jan 2023. https://www.510kdatabase.net/k222221/ 2023-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k222221-deka-helix-fda-510k.jpg K222221 - DEKA HELIX K222221 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: El.En Electronic Engineering Spa. Cleared Jan 2023. https://www.510kdatabase.net/k222483/ 2023-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k222483-surgical-face-mask-fda-510k.jpg K222483 - Surgical Face Mask K222483 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hubei Woozon Healthcare Co., Ltd.. Cleared Jan 2023. https://www.510kdatabase.net/k222907/ 2023-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k222907-nitrile-powder-free-examination-glove-fda-510k.jpg K222907 - Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate K222907 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Rmkh Glove (Cambodia) Co., Ltd.. Cleared Jan 2023. https://www.510kdatabase.net/k223411/ 2023-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k223411-disposable-isolation-gowns-smlxlxxlxxxl-fda-510k.jpg K223411 - Disposable Isolation Gowns (S,M,L,XL,XXL,XXXL) K223411 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Xiamen Probtain Medical Techology Co., Ltd.. Cleared Jan 2023. https://www.510kdatabase.net/k223635/ 2023-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k223635-sonoclot-coagulation-platelet-function-fda-510k.jpg K223635 - Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer K223635 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sienco, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k223685/ 2023-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k223685-smoothcool-hr-system-fda-510k.jpg K223685 - SmoothCool HR System K223685 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Jeisys Medical, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k220847/ 2023-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k220847-aetos-shoulder-system-fda-510k.jpg K220847 - AETOS Shoulder System K220847 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jan 2023. https://www.510kdatabase.net/k222809/ 2023-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k222809-medical-disposable-face-masks-fda-510k.jpg K222809 - Medical Disposable Face Masks K222809 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Anqing Mayfield Medical Limited. Cleared Jan 2023. https://www.510kdatabase.net/k223378/ 2023-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k223378-30t-16ch-air-aa-fda-510k.jpg K223378 - 3.0T 16ch AIR AA K223378 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare Coils (Usa Instruments, Inc.). Cleared Jan 2023. https://www.510kdatabase.net/k223775/ 2023-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k223775-ez-stik-electrodes-fda-510k.jpg K223775 - EZ-STIK Electrodes K223775 is a FDA 510(k) cleared neurology medical device. Manufacturer: South Dakota Partners. Cleared Jan 2023. https://www.510kdatabase.net/k210313/ 2022-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k210313-easyfinder-fixed-curve-diagnostic-fda-510k.jpg K210313 - EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter K210313 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shanghai Microport EP Medtech Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k213260/ 2022-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k213260-cmflextm-fda-510k.jpg K213260 - CMFlexTM K213260 is a FDA 510(k) cleared dental medical device. Manufacturer: Dimension Inx Corp.. Cleared Dec 2022. https://www.510kdatabase.net/k213430/ 2022-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k213430-fingertip-pulse-oximeter-fda-510k.jpg K213430 - Fingertip Pulse Oximeter K213430 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Witleaf Medical Electronics Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k214041/ 2022-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k214041-aesculap-aicon-container-fda-510k.jpg K214041 - Aesculap AICON Container K214041 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Aesculap, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k221358/ 2022-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k221358-isolator-linear-pen-mlp1-fda-510k.jpg K221358 - Isolator® Linear Pen (MLP1) K221358 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: AtriCure, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k221796/ 2022-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k221796-cyware-4h-and-cysart-4h-fda-510k.jpg K221796 - Cyware 4H and Cysart 4H K221796 is a FDA 510(k) cleared radiology medical device. Manufacturer: Abys Medical. Cleared Dec 2022. https://www.510kdatabase.net/k222002/ 2022-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k222002-persyst-15-eeg-review-and-analysis-fda-510k.jpg K222002 - Persyst 15 EEG Review and Analysis Software K222002 is a FDA 510(k) cleared neurology medical device. Manufacturer: Persyst Development Corporation. Cleared Dec 2022. https://www.510kdatabase.net/k222010/ 2022-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k222010-biobeat-platform-2-and-bb-613wp-patch-fda-510k.jpg K222010 - Biobeat Platform-2 and BB-613WP Patch K222010 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biobeat Technologies , Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k222195/ 2022-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k222195-aprevo-digital-workflow-fda-510k.jpg K222195 - aprevo® Digital Workflow K222195 is a FDA 510(k) cleared radiology medical device. Manufacturer: Carlsmed, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k222767/ 2022-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k222767-peekmed-web-v1-fda-510k.jpg K222767 - PeekMed web (v1) K222767 is a FDA 510(k) cleared radiology medical device. Manufacturer: Peek Health, S.A.. Cleared Dec 2022. https://www.510kdatabase.net/k222872/ 2022-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k222872-dna-appliance-fda-510k.jpg K222872 - DNA Appliance K222872 is a FDA 510(k) cleared dental medical device. Manufacturer: Vivos Therapeutics, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k223605/ 2022-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k223605-controlseal-electrode-elsb-fda-510k.jpg K223605 - ControlSeal Electrode (ELSB) K223605 is a FDA 510(k) cleared neurology medical device. Manufacturer: Coapt. Cleared Dec 2022. https://www.510kdatabase.net/k223616/ 2022-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k223616-acquire-s-endoscopic-ultrasound-fine-fda-510k.jpg K223616 - Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device K223616 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Dec 2022. https://www.510kdatabase.net/k223687/ 2022-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k223687-x-ray-flat-panel-detectors-everestview-fda-510k.jpg K223687 - X-ray Flat Panel Detectors (EverestView 4343X) K223687 is a FDA 510(k) cleared radiology medical device. Manufacturer: Careray Digital Medical Technology Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k211557/ 2022-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k211557-endopatx-fda-510k.jpg K211557 - EndoPATx K211557 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Itamar Medical , Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k211619/ 2022-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k211619-multi-parameter-patient-monitor-fda-510k.jpg K211619 - Multi-Parameter Patient Monitor K211619 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Comen Medical Instruments Co.,Ltd. Cleared Dec 2022. https://www.510kdatabase.net/k220935/ 2022-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k220935-digital-dialysis-clinic-intelligent-fda-510k.jpg K220935 - Digital Dialysis Clinic - Intelligent Dialysis Assistant (IDA) with Medical Supervision Portal and IDA Smartphone App K220935 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Iren-Medical, Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k221333/ 2022-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k221333-acumed-acutrak-system-mr-conditional-fda-510k.jpg K221333 - Acumed Acutrak System- MR Conditional, Acumed Acturak 2 System- MR Conditional K221333 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Acumed, LLC. Cleared Dec 2022. https://www.510kdatabase.net/k221477/ 2022-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k221477-ag100s-fda-510k.jpg K221477 - AG100s K221477 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Hospitech Respiration , Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k221690/ 2022-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k221690-oes-cystonephro-fiberscope-olympus-cyf-fda-510k.jpg K221690 - OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5), OES CYSTONEPHRO FIBERSCOPE (OLYMPUS CYF-5R), LIGHT GUIDE ADAPTER (MAJ-1413) K221690 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Dec 2022. https://www.510kdatabase.net/k221859/ 2022-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k221859-atalante-fda-510k.jpg K221859 - Atalante K221859 is a FDA 510(k) cleared neurology medical device. Manufacturer: Wandercraft SAS. Cleared Dec 2022. https://www.510kdatabase.net/k221981/ 2022-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k221981-safer-syringe-and-safer-sting-fda-510k.jpg K221981 - SafeR Syringe and SafeR Sting K221981 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Roncadelle Operations Srl. Cleared Dec 2022. https://www.510kdatabase.net/k222528/ 2022-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k222528-well-life-probe-electrode-for-fda-510k.jpg K222528 - Well-Life Probe Electrode for Stimulation/EMG Probe (Model: SA), Well-Life Incontinence Stimulation/EMG Electrode Probe, Well-Life Probe Electrode K222528 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Well-Life Healthcare Limited. Cleared Dec 2022. https://www.510kdatabase.net/k222984/ 2022-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k222984-bioclean-implant-restorative-system-fda-510k.jpg K222984 - BioClean Implant Restorative System K222984 is a FDA 510(k) cleared dental medical device. Manufacturer: Bioclean Dental, LLC. Cleared Dec 2022. https://www.510kdatabase.net/k223324/ 2022-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k223324-total-bilirubin2-fda-510k.jpg K223324 - Total Bilirubin2 K223324 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Ireland Diagnostics Division. Cleared Dec 2022. https://www.510kdatabase.net/k223592/ 2022-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k223592-advanix-pancreatic-stent-and-naviflex-fda-510k.jpg K223592 - Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers K223592 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Dec 2022. https://www.510kdatabase.net/k223603/ 2022-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k223603-reflow-system-mini-and-reflow-mini-fda-510k.jpg K223603 - Reflow System Mini and ReFlow Mini Flusher K223603 is a FDA 510(k) cleared neurology medical device. Manufacturer: Anuncia Medical, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k223647/ 2022-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k223647-clearbrilliant-touch-laser-system-fda-510k.jpg K223647 - CLEAR+BRILLIANT TOUCH® Laser System K223647 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Solta Medical, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k221344/ 2022-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k221344-nview-s1-with-nav-option-fda-510k.jpg K221344 - nView s1 with nav option K221344 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nview Medical. Cleared Dec 2022. https://www.510kdatabase.net/k221660/ 2022-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k221660-rhino-laryngofiberscope-olympus-enf-fda-510k.jpg K221660 - RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP K221660 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Dec 2022. https://www.510kdatabase.net/k222760/ 2022-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k222760-stageone-select-hip-cement-spacer-molds-fda-510k.jpg K222760 - StageOne™ Select Hip Cement Spacer Molds K222760 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k223286/ 2022-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k223286-bd-autoshield-duo-pen-needle-fda-510k.jpg K223286 - BD AutoShield Duo™ Pen Needle K223286 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson and Company. Cleared Dec 2022. https://www.510kdatabase.net/k223654/ 2022-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k223654-medussa-pl-cage-fda-510k.jpg K223654 - Medussa-PL Cage K223654 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medyssey USA, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k220974/ 2022-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k220974-rgen-fda-510k.jpg K220974 - R:GEN K220974 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Lutronic Vision, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k221669/ 2022-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k221669-iob-warming-blankets-fda-510k.jpg K221669 - IOB Warming Blankets K221669 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Iob Medical, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k221990/ 2022-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k221990-access-total-hcg-5th-is-fda-510k.jpg K221990 - Access Total ßhCG (5th IS) K221990 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k222978/ 2022-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k222978-poly-tapeinfinity-lock-soft-tissue-fda-510k.jpg K222978 - Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device K222978 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Xiros, Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k223094/ 2022-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k223094-ensite-x-ep-system-tactiflex-ablation-fda-510k.jpg K223094 - EnSite™ X EP System TactiFlex™ Ablation Catheter, Sensor Enabled™, Software Upgrade K223094 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared Dec 2022. https://www.510kdatabase.net/k210017/ 2022-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k210017-actonco-actonco-ivd-fda-510k.jpg K210017 - ACTOnco, ACTOnco IVD K210017 is a FDA 510(k) cleared pathology medical device. Manufacturer: Act Genomics. Cleared Dec 2022. https://www.510kdatabase.net/k211485/ 2022-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k211485-sta-neoptimal-fda-510k.jpg K211485 - STA- NeoPTimal K211485 is a FDA 510(k) cleared hematology medical device. Manufacturer: Diagnostica Stago S.A.S. Cleared Dec 2022. https://www.510kdatabase.net/k212239/ 2022-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k212239-xenoview-30t-chest-coil-fda-510k.jpg K212239 - XENOVIEW 3.0T Chest Coil K212239 is a FDA 510(k) cleared radiology medical device. Manufacturer: Polarean, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k214002/ 2022-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k214002-cryocheck-chromogenic-factor-ix-fda-510k.jpg K214002 - CRYOcheck Chromogenic Factor IX K214002 is a FDA 510(k) cleared hematology medical device. Manufacturer: Precision Biologic, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k214036/ 2022-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k214036-aview-fda-510k.jpg K214036 - AVIEW K214036 is a FDA 510(k) cleared radiology medical device. Manufacturer: Coreline Soft Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k221048/ 2022-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k221048-episealer-patellofemoral-system-fda-510k.jpg K221048 - Episealer Patellofemoral System K221048 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Episurf Medical, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k221193/ 2022-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k221193-ossiofiber-compression-screw-fda-510k.jpg K221193 - OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm K221193 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OSSIO , Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k221708/ 2022-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k221708-cimilre-free-t2-plus-fda-510k.jpg K221708 - CIMILRE Free-T2 Plus K221708 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Cimilre Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k221765/ 2022-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k221765-online-dat-benzodiazepines-ii-fda-510k.jpg K221765 - ONLINE DAT Benzodiazepines II K221765 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics. Cleared Dec 2022. https://www.510kdatabase.net/k222164/ 2022-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k222164-visant-medical-canalicular-plug-fda-510k.jpg K222164 - Visant Medical Canalicular Plug K222164 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Visant Medical, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k222726/ 2022-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k222726-smartpump-30-double-electric-breast-pump-fda-510k.jpg K222726 - Smartpump 3.0 Double Electric Breast Pump K222726 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Lansinoh Laboratories. Cleared Dec 2022. https://www.510kdatabase.net/k222748/ 2022-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k222748-shineo-silicone-implant-fda-510k.jpg K222748 - ShiNeo Silicone Implant K222748 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shineo Technology Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k222924/ 2022-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k222924-leg-massager-rf-alm070-fda-510k.jpg K222924 - Leg Massager RF-ALM070 K222924 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Shenzhen Ruiyi Business Technology Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k223071/ 2022-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k223071-xenoview-vdp-fda-510k.jpg K223071 - Xenoview VDP K223071 is a FDA 510(k) cleared radiology medical device. Manufacturer: Polarean, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k223289/ 2022-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k223289-access-vitamin-b12-fda-510k.jpg K223289 - Access Vitamin B12 K223289 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k223442/ 2022-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k223442-mr-5300-and-mr-7700-r11-mr-systems-fda-510k.jpg K223442 - MR 5300 and MR 7700 R11 MR Systems K223442 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederlands B.V.. Cleared Dec 2022. https://www.510kdatabase.net/k223565/ 2022-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k223565-lnk-spinal-fixation-system-openloc-l-fda-510k.jpg K223565 - LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System. K223565 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: L & K Biomed Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/den220017/ 2022-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/den220017-bioxmark-fda-510k.jpg DEN220017 - BioXmark DEN220017 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nanovi A/S. Cleared Dec 2022. https://www.510kdatabase.net/k211058/ 2022-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k211058-lpa-ultra-fda-510k.jpg K211058 - Lp(a) Ultra K211058 is a FDA 510(k) cleared chemistry medical device. Manufacturer: SENTINEL CH. SpA. Cleared Dec 2022. https://www.510kdatabase.net/k221377/ 2022-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k221377-steriking-lt-blueline-pouches-with-tyvek-fda-510k.jpg K221377 - SteriKing LT-Blueline Pouches with Tyvek K221377 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wipak OY. Cleared Dec 2022. https://www.510kdatabase.net/k221396/ 2022-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k221396-arthrex-fibertak-suture-anchor-fda-510k.jpg K221396 - Arthrex FiberTak Suture Anchor K221396 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k221428/ 2022-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k221428-periostom-dental-dressing-fda-510k.jpg K221428 - PerioStom Dental Dressing K221428 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Forward Science, LLC. Cleared Dec 2022. https://www.510kdatabase.net/k222216/ 2022-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k222216-truwave-disposable-pressure-transducer-fda-510k.jpg K222216 - TruWave Disposable Pressure Transducer K222216 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Dec 2022. https://www.510kdatabase.net/k222262/ 2022-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k222262-sunrise-fda-510k.jpg K222262 - Sunrise K222262 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sunrise SA. Cleared Dec 2022. https://www.510kdatabase.net/k222774/ 2022-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k222774-ifuse-bedrock-granite-implant-system-fda-510k.jpg K222774 - iFuse Bedrock Granite® Implant System K222774 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SI-BONE, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k222806/ 2022-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k222806-kodiak-c-spinal-implant-system-fda-510k.jpg K222806 - Kodiak C Spinal Implant System K222806 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Met One Technologies, LLC. Cleared Dec 2022. https://www.510kdatabase.net/k222894/ 2022-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k222894-invisalign-system-pre-formed-fda-510k.jpg K222894 - Invisalign System, Pre-Formed Attachment System K222894 is a FDA 510(k) cleared dental medical device. Manufacturer: Align Technology, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k222949/ 2022-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k222949-air-compression-leg-massager-model-ly-fda-510k.jpg K222949 - Air Compression Leg Massager (Model: LY-670D) K222949 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zhejiang Luyao Electronics Technology Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k223105/ 2022-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k223105-tesera-k-sc-system-fda-510k.jpg K223105 - Tesera-K SC System K223105 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Kyocera Medical Technologies, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k223142/ 2022-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k223142-coltolux-comfort-led-curing-light-fda-510k.jpg K223142 - Coltolux Comfort LED Curing Light K223142 is a FDA 510(k) cleared dental medical device. Manufacturer: Dent4you AG. Cleared Dec 2022. https://www.510kdatabase.net/k223273/ 2022-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k223273-astra-spine-system-fda-510k.jpg K223273 - ASTRA Spine System K223273 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinecraft, LLC. Cleared Dec 2022. https://www.510kdatabase.net/k223311/ 2022-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k223311-philips-ct-3500-fda-510k.jpg K223311 - Philips CT 3500 K223311 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Healthcare (Suzhou) Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k223508/ 2022-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k223508-cardioblate-gemini-s-49260-surgical-fda-510k.jpg K223508 - Cardioblate Gemini-s 49260 Surgical Ablation Device K223508 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k223547/ 2022-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k223547-biograph-vision-quadra-petct-system-fda-510k.jpg K223547 - Biograph Vision Quadra PET/CT System K223547 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k223649/ 2022-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k223649-verticale-navigation-instruments-fda-510k.jpg K223649 - VERTICALE® Navigation Instruments K223649 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Silony Medical GmbH. Cleared Dec 2022. https://www.510kdatabase.net/k202965/ 2022-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k202965-cura-temp-fda-510k.jpg K202965 - CURA-Temp K202965 is a FDA 510(k) cleared dental medical device. Manufacturer: Mgnewton , Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k213235/ 2022-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k213235-pentax-medical-one-pulmo-single-use-fda-510k.jpg K213235 - PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System K213235 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Pentax of America, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k213564/ 2022-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k213564-biwaze-clear-system-fda-510k.jpg K213564 - BiWaze Clear System K213564 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Abmrc, LLC. Cleared Dec 2022. https://www.510kdatabase.net/k213875/ 2022-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k213875-dri-tm-tricyclics-serum-tox-assay-fda-510k.jpg K213875 - DRI TM Tricyclics Serum Tox Assay K213875 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Microgenics Corporation. Cleared Dec 2022. https://www.510kdatabase.net/k213893/ 2022-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k213893-comfort-gown-safewear-gown-fda-510k.jpg K213893 - Comfort Gown, Safewear Gown K213893 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Xuchang Zhengde Environstar Medical Products Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k220012/ 2022-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k220012-bresodx1-fda-510k.jpg K220012 - BresoDX1 K220012 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Bresotec, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k220286/ 2022-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k220286-electrocyn-soma-fda-510k.jpg K220286 - ELECTROCYN soma K220286 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: V3Bio Sdn. Bhd. Cleared Dec 2022. https://www.510kdatabase.net/k221054/ 2022-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k221054-core-injector-fda-510k.jpg K221054 - CORE-INJECTOR K221054 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Incore Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k221221/ 2022-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k221221-advanced-intramedullary-nail-system-fda-510k.jpg K221221 - Advanced Intramedullary Nail System K221221 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Double Medical Technology, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k221698/ 2022-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k221698-eargo-5-eargo-6-fda-510k.jpg K221698 - Eargo 5 , Eargo 6 K221698 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Eargo, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k221720/ 2022-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k221720-extra-silver-gelling-fiber-dressing-fda-510k.jpg K221720 - Extra Silver Gelling Fiber Dressing K221720 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Winner Medical Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k221826/ 2022-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k221826-bd-bbl-sensi-disc-cefiderocol-30ug-fdc-fda-510k.jpg K221826 - BD BBL Sensi-Disc Cefiderocol 30ug (FDC-30) K221826 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson and Company. Cleared Dec 2022. https://www.510kdatabase.net/k221902/ 2022-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k221902-limflow-vector-fda-510k.jpg K221902 - LimFlow Vector K221902 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: LimFlow, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k221911/ 2022-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k221911-vinno-6pro-vinno-6exp-vinno-5pro-vinno-fda-510k.jpg K221911 - VINNO 6PRO, VINNO 6EXP, VINNO 5PRO, VINNO 5EXP, VINNO 3, VINNO 3PRO, VINNO 3EXP K221911 is a FDA 510(k) cleared radiology medical device. Manufacturer: Vinno Technology (Suzhou) Co.,Ltd. Cleared Dec 2022. https://www.510kdatabase.net/k222234/ 2022-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k222234-glucosure-advance-link-blood-glucose-fda-510k.jpg K222234 - GlucoSure ADVANCE Link Blood Glucose Monitoring System K222234 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Apex BioTechnology Corp.. Cleared Dec 2022. https://www.510kdatabase.net/k222351/ 2022-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k222351-inspired-vhb20-heated-humidifier-fda-510k.jpg K222351 - inspired™ VHB20 Heated Humidifier K222351 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Vincent Healthcare Products Limited. Cleared Dec 2022. https://www.510kdatabase.net/k222538/ 2022-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k222538-nc-rockstar-non-compliant-ptca-balloon-fda-510k.jpg K222538 - NC ROCKSTAR Non-Compliant PTCA Balloon Dilatation Catheter K222538 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sino Medical Sciences Technology, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k222586/ 2022-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k222586-mural-clinical-viewer-fda-510k.jpg K222586 - Mural Clinical Viewer K222586 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k222637/ 2022-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k222637-trimed-wrist-fixation-system-3-fda-510k.jpg K222637 - TriMed Wrist Fixation System 3 K222637 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: TriMed, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k222864/ 2022-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k222864-8mp-color-lcd-monitor-cl-r813-fda-510k.jpg K222864 - 8MP Color LCD Monitor CL-R813 K222864 is a FDA 510(k) cleared radiology medical device. Manufacturer: Jvckenwood Corporation. Cleared Dec 2022. https://www.510kdatabase.net/k222867/ 2022-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k222867-ad-2126-transcutaneous-electrical-fda-510k.jpg K222867 - AD-2126 Transcutaneous Electrical Nerve Stimulators (TENS) K222867 is a FDA 510(k) cleared neurology medical device. Manufacturer: Andon Health Co, Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k223050/ 2022-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k223050-azur-hydropack-18-45-880005-fda-510k.jpg K223050 - AZUR HydroPack 18 (45-880005 K223050 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: MicroVention, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k223244/ 2022-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k223244-pristine-arthroscopic-visualization-fda-510k.jpg K223244 - Pristine Arthroscopic Visualization System K223244 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Pristine Surgical. Cleared Dec 2022. https://www.510kdatabase.net/k223482/ 2022-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k223482-revive-light-therapy-wrinkle-and-acne-fda-510k.jpg K223482 - reVive Light Therapy® Wrinkle and Acne LED Device K223482 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Led Technologies, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k213677/ 2022-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k213677-bonafix-2-plus-fda-510k.jpg K213677 - Bonafix 2 Plus K213677 is a FDA 510(k) cleared dental medical device. Manufacturer: Zentek Medical, LLC. Cleared Dec 2022. https://www.510kdatabase.net/k220517/ 2022-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k220517-ibs-system-fda-510k.jpg K220517 - IBS System K220517 is a FDA 510(k) cleared dental medical device. Manufacturer: Innobiosurg Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k220991/ 2022-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k220991-intellisep-test-fda-510k.jpg K220991 - IntelliSep test K220991 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Cytovale, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k221004/ 2022-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k221004-hopkins-telescopes-fda-510k.jpg K221004 - HOPKINS Telescopes K221004 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k221011/ 2022-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k221011-aime-system-fda-510k.jpg K221011 - AI.ME System K221011 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Venus Concept USA, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k221031/ 2022-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k221031-arthrex-dualcompression-hindfoot-fda-510k.jpg K221031 - Arthrex DualCompression Hindfoot Fusion Nail Implant System K221031 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k221039/ 2022-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k221039-infrared-thermometer-models-aoj-20a-fda-510k.jpg K221039 - Infrared Thermometer, models AOJ-20A, AOJ-20B, AOJ-20C, AOJ-20D, AOJ-20E, AOJ-20F, AOJ-20H, AOJ-20M, AOJ-20T, AOJ-20R and AOJ-20Y K221039 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen AOJ Medical Technology Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k221070/ 2022-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k221070-dp4-microneedling-device-fda-510k.jpg K221070 - DP4 Microneedling device K221070 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Equipmed USA, LLC. Cleared Dec 2022. https://www.510kdatabase.net/k221603/ 2022-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k221603-kangaroo-omni-enteral-feeding-pump-fda-510k.jpg K221603 - Kangaroo OMNI™ Enteral Feeding Pump (385400 ) K221603 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cardinal Health, LLC. Cleared Dec 2022. https://www.510kdatabase.net/k221735/ 2022-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k221735-mineral-collagen-composite-bioactive-fda-510k.jpg K221735 - Mineral Collagen Composite Bioactive Moldable K221735 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Collagen Matrix, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k221775/ 2022-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k221775-led-light-therapy-mask-model-mk-78-mk-fda-510k.jpg K221775 - LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003) K221775 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Light Tree Ventures Europe B.V.. Cleared Dec 2022. https://www.510kdatabase.net/k221904/ 2022-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k221904-ek12-v2-algorithm-fda-510k.jpg K221904 - EK12 V2 Algorithm K221904 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k221926/ 2022-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k221926-invictus-bone-cement-invictus-spinal-fda-510k.jpg K221926 - Invictus® Bone Cement, Invictus Spinal Fixation System K221926 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k222308/ 2022-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k222308-al-smile-aligner-fda-510k.jpg K222308 - Al Smile Aligner K222308 is a FDA 510(k) cleared dental medical device. Manufacturer: Nanjing Jiahe Dental Technology Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k222358/ 2022-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k222358-indigo-aspiration-system-lightning-flash-fda-510k.jpg K222358 - Indigo Aspiration System - Lightning Flash K222358 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Penumbra, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k222405/ 2022-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k222405-smart-space-shoulder-planner-and-3d-fda-510k.jpg K222405 - Smart SPACE Shoulder Planner and 3D Positioners K222405 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Lima Corporate S.P.A.. Cleared Dec 2022. https://www.510kdatabase.net/k222808/ 2022-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k222808-penumbra-system-reperfusion-catheter-fda-510k.jpg K222808 - Penumbra System (Reperfusion Catheter RED 43) K222808 is a FDA 510(k) cleared neurology medical device. Manufacturer: Penumbra, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k222896/ 2022-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k222896-airray-fda-510k.jpg K222896 - AirRay K222896 is a FDA 510(k) cleared radiology medical device. Manufacturer: Poskom Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k223140/ 2022-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k223140-aeon-c-stand-alone-system-fda-510k.jpg K223140 - AEON-C™ Stand Alone System K223140 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Dio Medical, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k223294/ 2022-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k223294-spinejack-expansion-kit-fda-510k.jpg K223294 - SpineJack® Expansion Kit K223294 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Instruments. Cleared Dec 2022. https://www.510kdatabase.net/k213196/ 2022-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k213196-marvel-growing-rods-fda-510k.jpg K213196 - MARVEL™ Growing Rods K213196 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k213653/ 2022-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k213653-4cis-black-marlin-plif-cage-system-fda-510k.jpg K213653 - 4CIS BLACK MARLIN PLIF CAGE SYSTEM, 4CIS DOLPHIN TLIF CAGE SYSTEM K213653 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Solco Biomedical Company India Private Limited. Cleared Dec 2022. https://www.510kdatabase.net/k214076/ 2022-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k214076-escem-fda-510k.jpg K214076 - EsCem K214076 is a FDA 510(k) cleared dental medical device. Manufacturer: Spident Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k221351/ 2022-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k221351-mechanical-guidewire-fda-510k.jpg K221351 - Mechanical Guidewire K221351 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baylis Medical Company, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k221896/ 2022-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k221896-breathid-hp-system-fda-510k.jpg K221896 - BreathID Hp System K221896 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Meridian Bioscience Israel , Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k222213/ 2022-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k222213-pulse-oximeter-uc-200-uc-201-uc-202-uc-fda-510k.jpg K222213 - Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104) K222213 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Unimed Medical Supplies, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k222217/ 2022-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k222217-viewflex-xtra-reprocessed-ice-catheter-fda-510k.jpg K222217 - ViewFlex Xtra Reprocessed ICE Catheter K222217 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared Dec 2022. https://www.510kdatabase.net/k222919/ 2022-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k222919-gore-enform-biomaterial-fda-510k.jpg K222919 - GORE® ENFORM Biomaterial K222919 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W. L. Gore and Associates, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k220881/ 2022-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k220881-inoue-balloon-a-fda-510k.jpg K220881 - INOUE BALLOON A K220881 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Toray Industries, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k212559/ 2022-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k212559-cardiophase-hscrp-fda-510k.jpg K212559 - CardioPhase® hsCRP K212559 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics Products GmbH. Cleared Dec 2022. https://www.510kdatabase.net/k213110/ 2022-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k213110-auxilock-peek-optima-screw-in-suture-fda-510k.jpg K213110 - AUXILOCK PEEK OPTIMA Screw-In Suture Anchor, AUXILOCK ROTADOR PEEK OPTIMA Screw-In Anchor K213110 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Auxein Medical Private Limited. Cleared Dec 2022. https://www.510kdatabase.net/k213601/ 2022-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k213601-surgical-mask-fda-510k.jpg K213601 - Surgical Mask K213601 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wuhan Zonsen Medical Products Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k213984/ 2022-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k213984-oximeter-model-jzk-301jzk-303jzk-fda-510k.jpg K213984 - Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307) K213984 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Zhengkang Technology Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k220010/ 2022-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k220010-daylily-single-use-sterile-embryo-fda-510k.jpg K220010 - Daylily Single Use Sterile Embryo Transfer Catheter K220010 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shanghai Horizon Medical Technology Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k220036/ 2022-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k220036-wellead-ureteral-catheter-fda-510k.jpg K220036 - Wellead Ureteral Catheter K220036 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Well Lead Medical Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k220052/ 2022-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k220052-copan-fecalswab-collection-transport-fda-510k.jpg K220052 - Copan FecalSwab Collection, Transport and Preservation System K220052 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Copan Italia Spa. Cleared Dec 2022. https://www.510kdatabase.net/k220281/ 2022-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k220281-multifiltratepro-system-fda-510k.jpg K220281 - multiFiltratePRO System K220281 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC. Cleared Dec 2022. https://www.510kdatabase.net/k220554/ 2022-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k220554-caduceus-s-fda-510k.jpg K220554 - Caduceus S K220554 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Taiwan Main Orthopaedic Biotechnology Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k220928/ 2022-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k220928-overjet-calculus-assist-fda-510k.jpg K220928 - Overjet Calculus Assist K220928 is a FDA 510(k) cleared radiology medical device. Manufacturer: Overjet, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k222275/ 2022-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k222275-saige-density-fda-510k.jpg K222275 - Saige-Density K222275 is a FDA 510(k) cleared radiology medical device. Manufacturer: DeepHealth, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k222502/ 2022-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k222502-klick-variants-power-race-monster-fda-510k.jpg K222502 - KLICK (VARIANTS: POWER, RACE, MONSTER) K222502 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Klaxon Mobility GmbH. Cleared Dec 2022. https://www.510kdatabase.net/k222608/ 2022-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k222608-tuttnauer-pre-vacuum-steam-sterilizer-fda-510k.jpg K222608 - Tuttnauer Pre-vacuum Steam Sterilizer models 3870HSG and 3870HSG-WS K222608 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Tuttnauer , Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k222798/ 2022-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k222798-rejoni-intrauterine-catheter-fda-510k.jpg K222798 - Rejoni Intrauterine Catheter K222798 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Rejoni, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k222820/ 2022-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k222820-brm-tool-screws-bioplan-subtalar-implant-fda-510k.jpg K222820 - BRM TOOL Screws, BIOPLAN Subtalar Implant K222820 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Brm Extremities. Cleared Dec 2022. https://www.510kdatabase.net/k223153/ 2022-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k223153-catalyft-ls-expandable-interbody-fda-510k.jpg K223153 - Catalyft LS Expandable Interbody System with Titan nanoLOCK Surface Technology K223153 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k223184/ 2022-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k223184-phantom-metatarsal-shortening-system-fda-510k.jpg K223184 - Phantom Metatarsal Shortening System K223184 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paragon 28, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k223237/ 2022-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k223237-sofwave-system-fda-510k.jpg K223237 - SofWave System K223237 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sofwave Medical, Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k223243/ 2022-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k223243-bd-microtainer-contact-activated-lancets-fda-510k.jpg K223243 - BD Microtainer® Contact-Activated Lancets K223243 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Becton, Dickinson and Company. Cleared Dec 2022. https://www.510kdatabase.net/k223251/ 2022-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k223251-hexanium-plif-fda-510k.jpg K223251 - Hexanium PLIF K223251 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinevision, S.A.S.. Cleared Dec 2022. https://www.510kdatabase.net/k223268/ 2022-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k223268-braininsight-fda-510k.jpg K223268 - BrainInsight K223268 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hyperfine, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k223334/ 2022-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k223334-sterile-hypodermic-needles-for-single-fda-510k.jpg K223334 - Sterile Hypodermic Needles for Single Use K223334 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zhejiang Kindly Medical Devices Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/den220012/ 2022-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/den220012-tornier-pyrocarbon-humeral-head-fda-510k.jpg DEN220012 - Tornier Pyrocarbon Humeral Head DEN220012 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tornier S.A.S.. Cleared Dec 2022. https://www.510kdatabase.net/k214086/ 2022-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k214086-bright-impress-light-bright-impress-fda-510k.jpg K214086 - Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty K214086 is a FDA 510(k) cleared dental medical device. Manufacturer: Genoss Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k220520/ 2022-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k220520-pm-excellence-sequr-100-surgical-face-fda-510k.jpg K220520 - PM Excellence SEQUR 100 Surgical Face Mask K220520 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Pm Excellence, LLC. Cleared Dec 2022. https://www.510kdatabase.net/k220591/ 2022-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k220591-proxima-fda-510k.jpg K220591 - Proxima K220591 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Dynasthetics, LLC. Cleared Dec 2022. https://www.510kdatabase.net/k220873/ 2022-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k220873-perceptive-electric-dental-motor-and-fda-510k.jpg K220873 - Perceptive electric dental motor and control unit K220873 is a FDA 510(k) cleared dental medical device. Manufacturer: Lares Research. Cleared Dec 2022. https://www.510kdatabase.net/k220883/ 2022-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k220883-small-field-applicator-fda-510k.jpg K220883 - Small Field Applicator K220883 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hitachi, Ltd. Radiation Oncology Systems, Kashiwanoha. Cleared Dec 2022. https://www.510kdatabase.net/k221102/ 2022-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k221102-lotus-series-4-enhanced-shears-lotus-fda-510k.jpg K221102 - LOTUS Series 4 Enhanced Shears, LOTUS Series 5 K221102 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sra Developments, Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k221267/ 2022-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k221267-vs-8-vital-signs-monitor-vs-8a-vital-fda-510k.jpg K221267 - VS 8 Vital Signs Monitor, VS 8A Vital Signs Monitor, VS 9 Vital Signs Monitor K221267 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k221453/ 2022-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k221453-sin-dental-implant-system-fda-510k.jpg K221453 - S.I.N. Dental Implant System K221453 is a FDA 510(k) cleared dental medical device. Manufacturer: S.I.N. ? Sistema DE Implante Nacional S.A.. Cleared Dec 2022. https://www.510kdatabase.net/k221555/ 2022-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k221555-dozee-vs-fda-510k.jpg K221555 - Dozee VS K221555 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Turtle Shell Technologies Private Limited. Cleared Dec 2022. https://www.510kdatabase.net/k222892/ 2022-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k222892-powder-free-polyurethane-examination-fda-510k.jpg K222892 - Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy Drugs K222892 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Grand Work Plastic Products Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k223472/ 2022-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k223472-tightrail-guardian-motorized-dilator-fda-510k.jpg K223472 - TightRail Guardian Motorized Dilator Sheath, 9 French (575-009) K223472 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Spectranetics, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k213722/ 2022-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k213722-ice-ceramics-ice-stains-fresco-fda-510k.jpg K213722 - ICE Ceramics, ICE Stains, Fresco K213722 is a FDA 510(k) cleared dental medical device. Manufacturer: Zirkonzahn Srl. Cleared Dec 2022. https://www.510kdatabase.net/k220079/ 2022-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k220079-magicore-narrow-system-fda-510k.jpg K220079 - Magicore Narrow System K220079 is a FDA 510(k) cleared dental medical device. Manufacturer: Innobiosurg Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k220971/ 2022-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k220971-quikclot-control-hemostatic-dressing-fda-510k.jpg K220971 - QuikClot Control+ Hemostatic Dressing K220971 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Z-Medica, LLC. Cleared Dec 2022. https://www.510kdatabase.net/k221245/ 2022-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k221245-pta-balloon-dilatation-catheter-fda-510k.jpg K221245 - PTA Balloon Dilatation Catheter K221245 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Kossel Medtech (Suzhou) Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k221800/ 2022-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k221800-infrared-thermometer-model-y20001-y20002-fda-510k.jpg K221800 - Infrared Thermometer (Model: Y20001, Y20002) K221800 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zhangzhou Easepal Medical Science and Technology Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k221891/ 2022-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k221891-uno-negative-pressure-wound-therapy-fda-510k.jpg K221891 - UNO Negative Pressure Wound Therapy System K221891 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Genadyne Biotechnologies, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k221910/ 2022-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k221910-qrs-dental-implants-system-fda-510k.jpg K221910 - QRS Dental Implants System K221910 is a FDA 510(k) cleared dental medical device. Manufacturer: Qrs Medical , Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k222527/ 2022-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k222527-nitrile-patient-examination-glove-fda-510k.jpg K222527 - Nitrile Patient Examination Glove K222527 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Pingan Medical Products Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k222533/ 2022-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k222533-target-tetra-detachable-coils-fda-510k.jpg K222533 - Target Tetra Detachable Coils K222533 is a FDA 510(k) cleared neurology medical device. Manufacturer: Stryker Neurovascular. Cleared Dec 2022. https://www.510kdatabase.net/k222623/ 2022-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k222623-digital-crown-fda-510k.jpg K222623 - Digital Crown K222623 is a FDA 510(k) cleared dental medical device. Manufacturer: Sprintray, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k212071/ 2022-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k212071-cefaly-dual-enhanced-with-rfid-otc-fda-510k.jpg K212071 - Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx K212071 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cefaly Technology. Cleared Dec 2022. https://www.510kdatabase.net/k213105/ 2022-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k213105-epilaser-absolute-fda-510k.jpg K213105 - Epilaser Absolute K213105 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Epilady 2000, LLC. Cleared Dec 2022. https://www.510kdatabase.net/k214004/ 2022-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k214004-ccbio-ascpo-needle-fda-510k.jpg K214004 - CCBIO ASCPO Needle K214004 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cc Biotechnology Corporation. Cleared Dec 2022. https://www.510kdatabase.net/k220046/ 2022-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k220046-superbio-fentanyl-urine-detection-kit-fda-510k.jpg K220046 - Superbio Fentanyl Urine Detection Kit, Superbio Immunofluorescence Analyzer EASY-11 K220046 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Shenzhen Superbio Technology Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k221318/ 2022-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k221318-hvt-20-fda-510k.jpg K221318 - HVT 2.0 K221318 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Vapotherm, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k221342/ 2022-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k221342-redemption-beaming-system-fda-510k.jpg K221342 - REDEMPTION Beaming System K221342 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Vilex, LLC. Cleared Dec 2022. https://www.510kdatabase.net/k222651/ 2022-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k222651-surgical-face-mask-fda-510k.jpg K222651 - Surgical Face Mask K222651 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Xiantao Sanda Industrial Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k222770/ 2022-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k222770-conductive-gel-fda-510k.jpg K222770 - Conductive Gel K222770 is a FDA 510(k) cleared neurology medical device. Manufacturer: Top-Rank Health Care Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k223433/ 2022-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k223433-quantra-qplus-system-fda-510k.jpg K223433 - Quantra QPlus System K223433 is a FDA 510(k) cleared hematology medical device. Manufacturer: Hemosonics, LLC. Cleared Dec 2022. https://www.510kdatabase.net/k202674/ 2022-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k202674-medidenta-high-speed-handpieces-fda-510k.jpg K202674 - Medidenta High Speed Handpieces K202674 is a FDA 510(k) cleared dental medical device. Manufacturer: Pac-Dent, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k212957/ 2022-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k212957-biobutton-system-fda-510k.jpg K212957 - BioButton System K212957 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biolntellisense, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k220921/ 2022-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k220921-metal-bone-screw-fda-510k.jpg K220921 - Metal Bone Screw K220921 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Double Medical Technology, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k220926/ 2022-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k220926-spectra-wearable-fda-510k.jpg K220926 - Spectra Wearable K220926 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Uzinmedicare Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k221355/ 2022-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k221355-vitros-immuodiagnostic-products-ca-125-fda-510k.jpg K221355 - VITROS Immuodiagnostic Products CA 125 II Reagent Pack K221355 is a FDA 510(k) cleared immunology medical device. Manufacturer: Ortho-Clinical Diagnostics. Cleared Dec 2022. https://www.510kdatabase.net/k221642/ 2022-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k221642-sirius-endoscope-system-fda-510k.jpg K221642 - SIRIUS Endoscope System K221642 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Precision Robotics (Hong Kong) Limited. Cleared Dec 2022. https://www.510kdatabase.net/k223190/ 2022-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k223190-hive-standalone-cervical-system-fda-510k.jpg K223190 - Hive™ Standalone Cervical System K223190 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: NanoHive Medical, LLC. Cleared Dec 2022. https://www.510kdatabase.net/k223510/ 2022-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k223510-matrix-ha-fusion-porous-cervical-ibf-fda-510k.jpg K223510 - Matrix HA Fusion Porous Cervical IBF System K223510 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Innovasis, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k222733/ 2022-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k222733-disposable-nitrile-examination-glove-fda-510k.jpg K222733 - Disposable Nitrile Examination Glove (Tested for use with Chemotherapy Drug) K222733 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Inner Mongolia Boming Medical Supplies Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k213054/ 2022-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k213054-medline-sure-snap-safety-needle-fda-510k.jpg K213054 - Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe K213054 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k220774/ 2022-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k220774-robpath-total-hip-application-fda-510k.jpg K220774 - RobPath® Total Hip Application K220774 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Hangzhou Lancet Robotics Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k220822/ 2022-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k220822-3d-shaper-fda-510k.jpg K220822 - 3D-SHAPER K220822 is a FDA 510(k) cleared radiology medical device. Manufacturer: 3D-Shaper Medical S.L. Cleared Dec 2022. https://www.510kdatabase.net/k220951/ 2022-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k220951-pmt-facet-fixation-system-pmt-ffs-fda-510k.jpg K220951 - PMT Facet Fixation System (PMT FFS) K220951 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Providence Medical Technology, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k221280/ 2022-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k221280-vesseal-fda-510k.jpg K221280 - Vesseal K221280 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lydus Medical , Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k221598/ 2022-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k221598-wearable-breast-pump-fda-510k.jpg K221598 - Wearable breast pump K221598 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Mayborn (Uk) Limited. Cleared Dec 2022. https://www.510kdatabase.net/k222086/ 2022-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k222086-inogen-rove-4-portable-oxygen-fda-510k.jpg K222086 - Inogen Rove 4 Portable Oxygen Concentrator K222086 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Inogen. Cleared Dec 2022. https://www.510kdatabase.net/k222117/ 2022-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k222117-swang-ganz-iq-pulmonary-artery-catheter-fda-510k.jpg K222117 - Swang-Ganz IQ pulmonary artery catheter K222117 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesiences, LLC. Cleared Dec 2022. https://www.510kdatabase.net/k222242/ 2022-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k222242-flopatch-fp120-fda-510k.jpg K222242 - FloPatch FP120 K222242 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Flosonics Medical. Cleared Dec 2022. https://www.510kdatabase.net/k222552/ 2022-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k222552-120v-neptune-s-rover-0711-001-000-fda-510k.jpg K222552 - 120V Neptune S Rover (0711-001-000) K222552 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker Instruments. Cleared Dec 2022. https://www.510kdatabase.net/k222650/ 2022-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k222650-stryker-cutomized-mandible-recon-plate-fda-510k.jpg K222650 - Stryker Cutomized Mandible Recon Plate K222650 is a FDA 510(k) cleared dental medical device. Manufacturer: Stryker Craniomaxillofacial (Cmf). Cleared Dec 2022. https://www.510kdatabase.net/k222753/ 2022-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k222753-seaspine-7d-navigation-instruments-fda-510k.jpg K222753 - SeaSpine 7D Navigation Instruments K222753 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared Dec 2022. https://www.510kdatabase.net/k222916/ 2022-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k222916-us-450-diode-laser-equipment-fda-510k.jpg K222916 - US 450 Diode Laser Equipment K222916 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Beijing Globalipl Development Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k223193/ 2022-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k223193-airos-8p-sequential-compression-device-fda-510k.jpg K223193 - AIROS 8P Sequential Compression Device K223193 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Airos Medical, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k223195/ 2022-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k223195-airos-6p-sequential-compression-device-fda-510k.jpg K223195 - AIROS 6P Sequential Compression Device K223195 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Airos Medical, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k223275/ 2022-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k223275-cello-ii-balloon-guide-catheter-fda-510k.jpg K223275 - CELLO II Balloon Guide Catheter K223275 is a FDA 510(k) cleared neurology medical device. Manufacturer: Fuji Systems Corporation. Cleared Dec 2022. https://www.510kdatabase.net/k223402/ 2022-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k223402-hemosil-von-willebrand-factor-antigen-fda-510k.jpg K223402 - HemosIL von Willebrand Factor Antigen K223402 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Dec 2022. https://www.510kdatabase.net/k223403/ 2022-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k223403-liaison-anti-hav-fda-510k.jpg K223403 - LIAISON Anti-HAV K223403 is a FDA 510(k) cleared microbiology medical device. Manufacturer: DiaSorin, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k211800/ 2022-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k211800-warrior-blood-and-fluid-warmer-warrior-fda-510k.jpg K211800 - Warrior Blood and Fluid Warmer, Warrior EXTREME Blood and Fluid Warmer, Warrior Lite Blood and Fluid Warmer K211800 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Quality IN Flow , Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k213210/ 2022-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k213210-oxygen-concentrator-model-jay-5aw-fda-510k.jpg K213210 - Oxygen Concentrator, Model JAY-5AW K213210 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Longfian Scitech Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k220667/ 2022-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k220667-sleeved-ic-fda-510k.jpg K220667 - Sleeved IC K220667 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hollister Incorporated. Cleared Dec 2022. https://www.510kdatabase.net/k220826/ 2022-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k220826-led-curing-light-fda-510k.jpg K220826 - LED Curing Light K220826 is a FDA 510(k) cleared dental medical device. Manufacturer: Foshan Coxo Medical Instrument Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k221182/ 2022-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k221182-southern-transforaminal-lumbar-fda-510k.jpg K221182 - Southern Transforaminal Lumbar Interbody Fusion (TLIF) K221182 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Southern Medical (Pty) , Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k221444/ 2022-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k221444-led-eye-perfector-model-ey-36a-ey-36b-fda-510k.jpg K221444 - LED Eye Perfector, model: EY-36A, EY-36B K221444 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Light Tree Ventures Europe B.V.. Cleared Dec 2022. https://www.510kdatabase.net/k221862/ 2022-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k221862-yy-a02-b-overlapped-compression-therapy-fda-510k.jpg K221862 - YY-A02-B Overlapped Compression Therapy K221862 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Huizhou Xinyi Technology Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k222038/ 2022-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k222038-centrimag-blood-pump-for-use-with-fda-510k.jpg K222038 - CentriMag™ Blood Pump for use with CentriMag™ Acute Circulatory Support System K222038 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott (Formerly Thoratec Corporation). Cleared Dec 2022. https://www.510kdatabase.net/k222471/ 2022-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k222471-irraflow-active-fluid-exchange-system-fda-510k.jpg K222471 - IRRAflow Active Fluid Exchange System (AFES) K222471 is a FDA 510(k) cleared neurology medical device. Manufacturer: Irras USA. Cleared Dec 2022. https://www.510kdatabase.net/k222750/ 2022-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k222750-yomi-robotic-system-fda-510k.jpg K222750 - Yomi Robotic System K222750 is a FDA 510(k) cleared dental medical device. Manufacturer: Neocis, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k222837/ 2022-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k222837-turbo-power-20mm-laser-atherectomy-fda-510k.jpg K222837 - Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters K222837 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Spectranetics, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k223112/ 2022-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k223112-maverick-mini-external-fixation-system-fda-510k.jpg K223112 - MAVERICK Mini External Fixation System K223112 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k223239/ 2022-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k223239-8ch-wrist-coil-fda-510k.jpg K223239 - 8ch Wrist Coil K223239 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen RF Tech Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k223487/ 2022-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k223487-inkspace-imaging-body-array-fda-510k.jpg K223487 - InkSpace Imaging Body Array K223487 is a FDA 510(k) cleared radiology medical device. Manufacturer: Inkspace Imaging, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k212567/ 2022-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k212567-pvc-hydrophilic-urethral-catheter-fda-510k.jpg K212567 - PVC Hydrophilic Urethral Catheter K212567 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Chengdu Daxan Innovative Medical Tech. Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k213919/ 2022-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k213919-dexcom-g7-continuous-glucose-fda-510k.jpg K213919 - Dexcom G7 Continuous Glucose Monitoring System K213919 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dexcom, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k220772/ 2022-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k220772-hydromid-4f-single-lumen-midline-fda-510k.jpg K220772 - HydroMID 4F Single Lumen Midline Catheter K220772 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Access Vascular, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k220843/ 2022-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k220843-oaktree-anterior-lumbar-plate-and-fda-510k.jpg K220843 - OAKTREE Anterior Lumbar Plate and Screw System K220843 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Oak Tree Engineering, LLC. Cleared Dec 2022. https://www.510kdatabase.net/k221626/ 2022-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k221626-jr-medic-blue-nitrile-examination-fda-510k.jpg K221626 - Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs and Fentanyl Citrate K221626 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jr Engineering & Medical Technologies (M) Sdn. Bhd.. Cleared Dec 2022. https://www.510kdatabase.net/k221836/ 2022-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k221836-filter-carestar-plus-filter-safestar-fda-510k.jpg K221836 - Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus K221836 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Dr?gerwerk AG & Co KGaA. Cleared Dec 2022. https://www.510kdatabase.net/k221842/ 2022-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k221842-elecsys-b-amyloid-1-42-csf-ii-elecsys-fda-510k.jpg K221842 - Elecsys B-Amyloid (1-42) CSF II, Elecsys Phospho-Tau (181P) CSF K221842 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics. Cleared Dec 2022. https://www.510kdatabase.net/k222441/ 2022-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k222441-ultrasound-system-2300-fda-510k.jpg K222441 - Ultrasound System 2300 K222441 is a FDA 510(k) cleared radiology medical device. Manufacturer: Bk Medical Aps. Cleared Dec 2022. https://www.510kdatabase.net/k223045/ 2022-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k223045-3-ply-disposable-medical-mask-fda-510k.jpg K223045 - 3-Ply Disposable Medical Mask K223045 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wealth Lead Industrial Limited. Cleared Dec 2022. https://www.510kdatabase.net/k223077/ 2022-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k223077-viewflex-xtra-ice-catheter-fda-510k.jpg K223077 - ViewFlex Xtra ICE Catheter K223077 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Irvine Biomedical, A St. Jude Medical Company. Cleared Dec 2022. https://www.510kdatabase.net/k223281/ 2022-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k223281-disposable-nitrile-examination-glove-fda-510k.jpg K223281 - Disposable Nitrile Examination Glove K223281 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Anhui Kindguard Medical Supplies Technology Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k223394/ 2022-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k223394-visionary-optics-scleral-contact-lens-fda-510k.jpg K223394 - Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A) K223394 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Visionary Optics, LLC. Cleared Dec 2022. https://www.510kdatabase.net/k223410/ 2022-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k223410-cios-select-va21-flat-panel-fda-510k.jpg K223410 - Cios Select (VA21) Flat Panel K223410 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k221021/ 2022-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k221021-femoral-trochanteric-nail-system-neonail-fda-510k.jpg K221021 - Femoral Trochanteric Nail System – Neonail K221021 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Neoortho Produtos Ortop?dicos S/A. Cleared Dec 2022. https://www.510kdatabase.net/k222219/ 2022-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k222219-r2-studio-qrct820-fda-510k.jpg K222219 - R2 Studio Q/RCT820 K222219 is a FDA 510(k) cleared radiology medical device. Manufacturer: Megagen Implant Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k222320/ 2022-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k222320-meddream-fda-510k.jpg K222320 - MedDream K222320 is a FDA 510(k) cleared radiology medical device. Manufacturer: Softneta Uab. Cleared Dec 2022. https://www.510kdatabase.net/k222385/ 2022-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k222385-bifurcated-needle-fda-510k.jpg K222385 - Bifurcated Needle K222385 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Anhui Tiankang Medical Technology Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k222541/ 2022-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k222541-bausch-lomb-preservative-free-fda-510k.jpg K222541 - Bausch + Lomb Preservative Free Lubricating and Rewetting Drops K222541 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Bausch & Lomb, Incorporated. Cleared Dec 2022. https://www.510kdatabase.net/k222575/ 2022-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k222575-hurrichem-device-kit-fda-510k.jpg K222575 - HurriChem Device Kit K222575 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Thermasolutions, LLC. Cleared Dec 2022. https://www.510kdatabase.net/k222626/ 2022-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k222626-dental-zirconia-ceramic-fda-510k.jpg K222626 - Dental Zirconia Ceramic K222626 is a FDA 510(k) cleared dental medical device. Manufacturer: Aidite (Qinhuangdao) Technology Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k222706/ 2022-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k222706-ice-sg2-subcutaneous-electrode-kit-fda-510k.jpg K222706 - iCE-SG2 Subcutaneous Electrode Kit K222706 is a FDA 510(k) cleared neurology medical device. Manufacturer: Ice Neurosystems, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k223247/ 2022-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k223247-swoop-portable-mr-imaging-system-fda-510k.jpg K223247 - Swoop Portable MR Imaging System K223247 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hyperfine, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k223386/ 2022-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k223386-optima-coil-system-fda-510k.jpg K223386 - Optima Coil System K223386 is a FDA 510(k) cleared neurology medical device. Manufacturer: Balt USA, LLC. Cleared Dec 2022. https://www.510kdatabase.net/k223409/ 2022-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k223409-cios-select-va21-image-intensifier-fda-510k.jpg K223409 - Cios Select (VA21) Image Intensifier K223409 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k223632/ 2022-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k223632-premiers-multimatch-universal-fda-510k.jpg K223632 - Premier's MultiMatch Universal Chameleon Restorative Composite K223632 is a FDA 510(k) cleared dental medical device. Manufacturer: Premier Dental Products Company. Cleared Dec 2022. https://www.510kdatabase.net/k213169/ 2022-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k213169-bpap-system-fda-510k.jpg K213169 - BPAP System K213169 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: BMC Medical Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k221612/ 2022-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k221612-clearread-ct-fda-510k.jpg K221612 - ClearRead CT K221612 is a FDA 510(k) cleared radiology medical device. Manufacturer: Riverain Technologies, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k221806/ 2022-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k221806-trulift-lateral-expandable-spacer-fda-510k.jpg K221806 - TruLift Lateral Expandable Spacer System & Lateral Plate System K221806 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k222137/ 2022-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k222137-ok-plus-indicator-fda-510k.jpg K222137 - OK Plus Indicator K222137 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Propper Manufacturing Co., Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k222614/ 2022-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k222614-zavation-spinal-system-fda-510k.jpg K222614 - Zavation Spinal System K222614 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zavation Medical Products, LLC. Cleared Dec 2022. https://www.510kdatabase.net/k222669/ 2022-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k222669-cryopush-cold-compression-device-fda-510k.jpg K222669 - Cryopush Cold Compression Device K222669 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Chengdu Cryo-Push Medical Technology Co.,Ltd. Cleared Dec 2022. https://www.510kdatabase.net/k222681/ 2022-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k222681-altaviz-needle-kit-fda-510k.jpg K222681 - Altaviz Needle Kit K222681 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Altaviz, LLC. Cleared Dec 2022. https://www.510kdatabase.net/k222689/ 2022-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k222689-mallya-injection-pen-adapter-mallya-fda-510k.jpg K222689 - Mallya Injection Pen Adapter (Mallya® for Solostar®) K222689 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Biocorp Production. Cleared Dec 2022. https://www.510kdatabase.net/k222692/ 2022-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k222692-briefcase-fda-510k.jpg K222692 - BriefCase K222692 is a FDA 510(k) cleared radiology medical device. Manufacturer: Aidoc Medical , Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k223055/ 2022-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k223055-disposable-medical-face-mask-fda-510k.jpg K223055 - Disposable Medical Face Mask K223055 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Xiantao Zhuobo Industrial Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k222019/ 2022-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k222019-reprocessed-rd-set-adt-pulse-oximeter-fda-510k.jpg K222019 - Reprocessed RD SET Adt Pulse Oximeter Sensor (4000), Reprocessed RD SET Pdt Pulse Oximeter Sensor (4001), Reprocessed RD SET Inf Pulse Oximeter Sensor (4002), Reprocessed RD SET Adt Pulse Oximeter Sensor (4003) K222019 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Stryker Sustainability Solutions. Cleared Dec 2022. https://www.510kdatabase.net/k222815/ 2022-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k222815-powder-free-nitrile-examination-gloves-fda-510k.jpg K222815 - Powder Free Nitrile Examination Gloves (Blue, White and Black), Tested For Use With Chemotherapy Drugs and Fentanyl K222815 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zibo Lanhua Medical Packaging Material Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k223004/ 2022-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k223004-disposable-nitrile-examination-gloves-fda-510k.jpg K223004 - Disposable Nitrile Examination Gloves K223004 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangxi Handspro Products Solutions Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k212866/ 2022-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k212866-trusculpt-flex-fda-510k.jpg K212866 - truSculpt flex K212866 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Johari Digital Healthcare Limited. Cleared Dec 2022. https://www.510kdatabase.net/k222713/ 2022-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k222713-white-nitrile-powder-free-patient-fda-510k.jpg K222713 - White Nitrile Powder Free Patient Examination Glove, Non Sterile K222713 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Safeskin Retailing (Hk) Limited. Cleared Dec 2022. https://www.510kdatabase.net/k222715/ 2022-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k222715-black-nitrile-powder-free-patient-fda-510k.jpg K222715 - Black Nitrile Powder Free Patient Examination Glove, Non Sterile K222715 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Safeskin Retailing (Hk) Limited. Cleared Dec 2022. https://www.510kdatabase.net/k222720/ 2022-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k222720-blue-nitrile-powder-free-patient-fda-510k.jpg K222720 - Blue Nitrile Powder Free Patient Examination Glove, Non Sterile K222720 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Safeskin Retailing (Hk) Limited. Cleared Dec 2022. https://www.510kdatabase.net/k213465/ 2022-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k213465-cardiographe-fda-510k.jpg K213465 - CardioGraphe K213465 is a FDA 510(k) cleared radiology medical device. Manufacturer: Arineta , Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k220390/ 2022-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k220390-creodent-solidex-customized-abutment-fda-510k.jpg K220390 - CreoDent Solidex Customized Abutment and Screw K220390 is a FDA 510(k) cleared dental medical device. Manufacturer: Creodent Prosthetics, Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k220611/ 2022-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k220611-surecore-plus-biopsy-instrument-fda-510k.jpg K220611 - SUREcore Plus Biopsy Instrument K220611 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Uro-1, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k220688/ 2022-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k220688-silentzpro-20-fda-510k.jpg K220688 - SilentZPro 2.0 K220688 is a FDA 510(k) cleared dental medical device. Manufacturer: Shinrin-Yoku Traders, LLC. Cleared Dec 2022. https://www.510kdatabase.net/k220778/ 2022-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k220778-chemical-indicator-for-steam-fda-510k.jpg K220778 - Chemical Indicator for Steam K220778 is a FDA 510(k) cleared general hospital medical device. Manufacturer: True Indicating, LLC. Cleared Dec 2022. https://www.510kdatabase.net/k221113/ 2022-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k221113-accutorr-3-vital-signs-monitor-rosebud-fda-510k.jpg K221113 - Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor K221113 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k221141/ 2022-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k221141-pagewriter-tc35-cardiograph-fda-510k.jpg K221141 - PageWriter TC35 Cardiograph K221141 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medizin Systeme Boblingen GmbH. Cleared Dec 2022. https://www.510kdatabase.net/k221401/ 2022-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k221401-self-cath-and-self-cath-plus-fda-510k.jpg K221401 - Self-Cath and Self-Cath Plus K221401 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Coloplast. Cleared Dec 2022. https://www.510kdatabase.net/k221410/ 2022-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k221410-maestro-platform-fda-510k.jpg K221410 - Maestro Platform K221410 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Moon Surgical. Cleared Dec 2022. https://www.510kdatabase.net/k221590/ 2022-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k221590-navicam-small-bowel-capsule-endoscopy-fda-510k.jpg K221590 - NaviCam Small Bowel Capsule Endoscopy System K221590 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ankon Technologies Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k223072/ 2022-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k223072-pentax-medical-video-esophagoscope-fda-510k.jpg K223072 - PENTAX Medical Video Esophagoscope EE17-J10 K223072 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Pentax of America, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k223211/ 2022-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k223211-inhancetm-shoulder-system-humeral-fda-510k.jpg K223211 - INHANCETM Shoulder System – Humeral Stems and Stemless K223211 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Ireland UC. Cleared Dec 2022. https://www.510kdatabase.net/k223218/ 2022-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k223218-parietene-macroporous-mesh-fda-510k.jpg K223218 - Parietene Macroporous Mesh K223218 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sofradim Production. Cleared Dec 2022. https://www.510kdatabase.net/k223353/ 2022-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k223353-dropsafetm-sicuratm-fda-510k.jpg K223353 - DropSafeTM SicuraTM K223353 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Pikdare Spa. Cleared Dec 2022. https://www.510kdatabase.net/k223369/ 2022-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k223369-trufreeze-console-pn-cc301-fda-510k.jpg K223369 - truFreeze Console, PN CC301 K223369 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: STERIS Corporation. Cleared Dec 2022. https://www.510kdatabase.net/k213768/ 2022-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k213768-bolt-navigation-system-fda-510k.jpg K213768 - Bolt Navigation System K213768 is a FDA 510(k) cleared radiology medical device. Manufacturer: Circinus Medical Technology, LLC. Cleared Dec 2022. https://www.510kdatabase.net/k220786/ 2022-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k220786-star-apollo-mapping-system-fda-510k.jpg K220786 - STAR Apollo Mapping System K220786 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Rhythm Al, Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k221747/ 2022-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k221747-nitrile-patient-examination-gloves-fda-510k.jpg K221747 - Nitrile Patient Examination Gloves Tested For Use With Chemotherapy Drugs K221747 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Fitone Latex Products Co., Ltd. Guangdong. Cleared Dec 2022. https://www.510kdatabase.net/k221791/ 2022-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k221791-probeam-360-proton-therapy-system-fda-510k.jpg K221791 - ProBeam 360° Proton Therapy System K221791 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k222118/ 2022-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k222118-2-way-100-silicone-cleartract-catheter-fda-510k.jpg K222118 - 2-Way 100% Silicone Cleartract Catheter K222118 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Silq Technologies, Corp.. Cleared Dec 2022. https://www.510kdatabase.net/k222125/ 2022-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k222125-arm-blood-pressure-monitor-models-aoj-fda-510k.jpg K222125 - Arm Blood Pressure Monitor, models AOJ-30A, AOJ-30B, AOJ-30C, AOJ-30D, AOJ-30E, AOJ-30F and AOJ-30G K222125 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen AOJ Medical Technology Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k222297/ 2022-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k222297-centrimag-pre-connected-pack-fda-510k.jpg K222297 - CentriMag Pre-connected Pack K222297 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott. Cleared Dec 2022. https://www.510kdatabase.net/k222340/ 2022-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k222340-chartis-precision-catheter-fda-510k.jpg K222340 - Chartis Precision Catheter K222340 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Pulmonx Corporation. Cleared Dec 2022. https://www.510kdatabase.net/k222368/ 2022-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k222368-mist-ic-fda-510k.jpg K222368 - MIST IC K222368 is a FDA 510(k) cleared dental medical device. Manufacturer: Imagine Milling Technologies, LLC. Cleared Dec 2022. https://www.510kdatabase.net/k222516/ 2022-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k222516-mercury-ii-spinal-system-fda-510k.jpg K222516 - Mercury® II Spinal System K222516 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinal Elements, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k222710/ 2022-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k222710-ipl-cooling-hair-removal-device-fda-510k.jpg K222710 - IPL Cooling Hair Removal Device K222710 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Siken 3D Technology Development Co., Ltd.. Cleared Dec 2022. https://www.510kdatabase.net/k223226/ 2022-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k223226-trigon-ha-stand-alone-wedge-fixation-fda-510k.jpg K223226 - Trigon™ HA Stand-Alone Wedge Fixation System K223226 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nvision Biomedical Technologies, Inc.. Cleared Dec 2022. https://www.510kdatabase.net/k212717/ 2022-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k212717-paneffort-aami-level-3-isolation-gown-fda-510k.jpg K212717 - Paneffort AAMI Level 3 Isolation Gown K212717 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Paneffort, LLC. Cleared Nov 2022. https://www.510kdatabase.net/k220254/ 2022-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k220254-neuron-spectrum-am-with-neuron-fda-510k.jpg K220254 - Neuron-Spectrum-AM with Neuron-Spectrum.NET Software K220254 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neurosoft , Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k221082/ 2022-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k221082-rhino-non-sterile-powder-free-nitrile-fda-510k.jpg K221082 - Rhino Non-Sterile, Powder-Free Nitrile Exam Gloves – Periwinkle Color Tested for Use with Chemotherapy Drugs, and Fentanyl K221082 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Rhino Health, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k221771/ 2022-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k221771-eea-circular-stapler-with-tri-staple-fda-510k.jpg K221771 - EEA Circular Stapler with Tri-Staple Technology K221771 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien. Cleared Nov 2022. https://www.510kdatabase.net/k222044/ 2022-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k222044-elos-accurate-customized-abutment-fda-510k.jpg K222044 - Elos Accurate Customized Abutment K222044 is a FDA 510(k) cleared dental medical device. Manufacturer: Elos Medtech Pinol A/S. Cleared Nov 2022. https://www.510kdatabase.net/k222299/ 2022-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k222299-steripath-micro-blood-collection-system-fda-510k.jpg K222299 - Steripath Micro Blood Collection System K222299 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Magnolia Medical Technologies. Cleared Nov 2022. https://www.510kdatabase.net/k222305/ 2022-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k222305-misslan-digital-pregnancy-rapid-test-fda-510k.jpg K222305 - MissLan™ Digital Pregnancy Rapid Test K222305 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Guangzhou Decheng Biotechnology Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k222472/ 2022-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k222472-lancing-system-sterile-lancet-for-fda-510k.jpg K222472 - Lancing System, Sterile Lancet for Single Use, Lancing Device K222472 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shandong Lianfa Medical Plastic Products Co. , Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k223328/ 2022-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k223328-purgo-fda-510k.jpg K223328 - Purgo K223328 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Aeroclean Technologies, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k213917/ 2022-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k213917-qstat-cartridge-fda-510k.jpg K213917 - QStat Cartridge K213917 is a FDA 510(k) cleared hematology medical device. Manufacturer: Hemosonics, LLC. Cleared Nov 2022. https://www.510kdatabase.net/k213943/ 2022-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k213943-smartsurgn-visualization-system-fda-510k.jpg K213943 - SmartSurgN Visualization System K213943 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smartsurgn Incorporated. Cleared Nov 2022. https://www.510kdatabase.net/k222408/ 2022-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k222408-disposable-safety-lancet-fda-510k.jpg K222408 - Disposable Safety Lancet K222408 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Beijing Ruicheng Medical Supplies Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k222641/ 2022-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k222641-signia-small-diameter-reloads-fda-510k.jpg K222641 - Signia™ Small Diameter Reloads Including Regular (Round) Tip Version K222641 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien. Cleared Nov 2022. https://www.510kdatabase.net/k211050/ 2022-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k211050-infrared-thermometer-model-jkh-300-jkh-fda-510k.jpg K211050 - Infrared Thermometer, Model: JKH-300, JKH-301, JKH-302, JKH-303, JKH-304 K211050 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jkh Health Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k220630/ 2022-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k220630-torchtm-software-fda-510k.jpg K220630 - TorchTM Software K220630 is a FDA 510(k) cleared radiology medical device. Manufacturer: Voximetry, Incorporated. Cleared Nov 2022. https://www.510kdatabase.net/k221279/ 2022-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k221279-pnovus-21-microcatheter-fda-510k.jpg K221279 - pNOVUS 21 Microcatheter K221279 is a FDA 510(k) cleared neurology medical device. Manufacturer: Phenox, Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k221556/ 2022-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k221556-t-line-hernia-mesh-fda-510k.jpg K221556 - T-Line Hernia Mesh K221556 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Deep Blue Medical Advances, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k222363/ 2022-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k222363-aevumed-phantom-lp-suture-anchors-fda-510k.jpg K222363 - Aevumed PHANTOM™-LP Suture Anchors K222363 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aevumed, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k222611/ 2022-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k222611-male-latex-condoms-fda-510k.jpg K222611 - Male Latex Condoms K222611 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Suzhou Colour-Way New Material Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k222652/ 2022-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k222652-aneroid-sphygmomanometer-fda-510k.jpg K222652 - Aneroid Sphygmomanometer K222652 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cardicare Company, Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k223039/ 2022-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k223039-da-vinci-e-200-electrosurgical-generator-fda-510k.jpg K223039 - da Vinci E-200 Electrosurgical Generator K223039 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical. Cleared Nov 2022. https://www.510kdatabase.net/k223099/ 2022-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k223099-facet-manatee-reusable-lancing-base-fda-510k.jpg K223099 - Facet Manatee Reusable Lancing Base K223099 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Facet Technologies, LLC. Cleared Nov 2022. https://www.510kdatabase.net/k223274/ 2022-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k223274-momentum-mis-posterior-spinal-fixation-fda-510k.jpg K223274 - Momentum® MIS Posterior Spinal Fixation System K223274 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ulrich Medical USA. Cleared Nov 2022. https://www.510kdatabase.net/k223009/ 2022-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k223009-wirelesswired-x-ray-flat-panel-detectors-fda-510k.jpg K223009 - Wireless/Wired X-Ray Flat Panel Detectors K223009 is a FDA 510(k) cleared radiology medical device. Manufacturer: Allengers Medical Systems Limited. Cleared Nov 2022. https://www.510kdatabase.net/k213215/ 2022-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k213215-vsi-holomedicine-fda-510k.jpg K213215 - VSI HoloMedicine K213215 is a FDA 510(k) cleared radiology medical device. Manufacturer: Apoqlar GmbH. Cleared Nov 2022. https://www.510kdatabase.net/k222612/ 2022-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k222612-powder-free-latex-examination-gloves-fda-510k.jpg K222612 - Powder-Free Latex examination gloves K222612 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guangdong Kingfa Sci. & Tech.Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k222918/ 2022-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k222918-dentcare-aligners-fda-510k.jpg K222918 - DentCare Aligners K222918 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentcare Dental Lab Pvt , Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k201460/ 2022-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k201460-closed-system-transfer-device-fda-510k.jpg K201460 - Closed System Transfer Device K201460 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shinva Ande Healthcare Apparatus Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k213459/ 2022-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k213459-glenoid-reconstruction-system-fda-510k.jpg K213459 - Glenoid Reconstruction System K213459 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Nov 2022. https://www.510kdatabase.net/k221152/ 2022-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k221152-curingpen-dental-curing-light-fda-510k.jpg K221152 - CuringPen Dental Curing Light K221152 is a FDA 510(k) cleared dental medical device. Manufacturer: Changzhou Sifary Medical Technology Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k221210/ 2022-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k221210-painshield-md-plus-fda-510k.jpg K221210 - PainShield MD PLUS K221210 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Nanovibronix, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k221815/ 2022-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k221815-electrosurgical-pencil-obs-db-obs-dr-fda-510k.jpg K221815 - Electrosurgical Pencil (OBS-Db, OBS-Dr, OBS-Dc, OBS-Df, OBS-Di, OBS-De) K221815 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Baisheng Medical Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k222452/ 2022-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k222452-disposable-automatically-retractable-fda-510k.jpg K222452 - Disposable Automatically Retractable Safety Syringes (with detachable needle) K222452 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shantou Wealy Medical Instrument Co.,Ltd. Cleared Nov 2022. https://www.510kdatabase.net/k222463/ 2022-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k222463-echogo-heart-failure-fda-510k.jpg K222463 - EchoGo Heart Failure K222463 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ultromics Limited. Cleared Nov 2022. https://www.510kdatabase.net/k222534/ 2022-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k222534-nitrile-patient-examination-glove-fda-510k.jpg K222534 - Nitrile Patient Examination Glove K222534 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangxi Jiangxi Zhonghong Pulin Medical Products Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k222569/ 2022-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k222569-ai-ray-dental-x-ray-device-fda-510k.jpg K222569 - Ai Ray Dental X-Ray Device K222569 is a FDA 510(k) cleared radiology medical device. Manufacturer: Guilin Woodpecker Medical Instrument Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k222656/ 2022-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k222656-lde4-lancing-device-fda-510k.jpg K222656 - LDE4 Lancing Device K222656 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: I-Sens, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k222967/ 2022-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k222967-avanti-orthopaedics-22mm-and-27mm-fda-510k.jpg K222967 - Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated Screws K222967 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Avanti Orthopaedics, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k223068/ 2022-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k223068-medical-protective-mask-model-8862-fda-510k.jpg K223068 - Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E) K223068 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guangdong Golden Leaves Technology Development Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k223292/ 2022-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k223292-tempsure-system-fda-510k.jpg K223292 - TempSure System K223292 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cynosure, LLC. Cleared Nov 2022. https://www.510kdatabase.net/k211507/ 2022-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k211507-airdog-x5-recirculating-air-cleaner-fda-510k.jpg K211507 - Airdog X5 Recirculating Air Cleaner (model KJ300F-X5) K211507 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Beiang Air Tech , Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k212736/ 2022-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k212736-canady-flex-robowrist-fda-510k.jpg K212736 - Canady Flex RoboWrist K212736 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Us Medical Innovations, LLC. Cleared Nov 2022. https://www.510kdatabase.net/k213427/ 2022-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k213427-primed-pediatric-facemask-fda-510k.jpg K213427 - PRIMED Pediatric Facemask K213427 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Primed Medical Products, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k220663/ 2022-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k220663-accuctp-fda-510k.jpg K220663 - AccuCTP K220663 is a FDA 510(k) cleared radiology medical device. Manufacturer: ArteryFlow Technology Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k221123/ 2022-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k221123-wise-cortical-strip-wcs-fda-510k.jpg K221123 - WISE Cortical Strip (WCS) K221123 is a FDA 510(k) cleared neurology medical device. Manufacturer: Wise S.R.L.. Cleared Nov 2022. https://www.510kdatabase.net/k221250/ 2022-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k221250-easyone-filter-fda-510k.jpg K221250 - EasyOne Filter K221250 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ndd Medizintechnik AG. Cleared Nov 2022. https://www.510kdatabase.net/k221412/ 2022-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k221412-arix-rib-system-fda-510k.jpg K221412 - ARIX Rib System K221412 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Jeil Medical Corporation. Cleared Nov 2022. https://www.510kdatabase.net/k221471/ 2022-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k221471-e3-and-profile-fda-510k.jpg K221471 - E3 and Profile K221471 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Diagnosys, LLC. Cleared Nov 2022. https://www.510kdatabase.net/k221499/ 2022-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k221499-minimally-invasive-prostate-surgery-fda-510k.jpg K221499 - Minimally Invasive Prostate Surgery Navigation System K221499 is a FDA 510(k) cleared radiology medical device. Manufacturer: Augment Intelligent Medical System (China) Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k221530/ 2022-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k221530-anne-pediatric-fda-510k.jpg K221530 - ANNE Pediatric K221530 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sibel, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k221608/ 2022-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k221608-navicam-capsule-endoscope-system-with-fda-510k.jpg K221608 - NaviCam Capsule Endoscope System with NaviCam Stomach Capsule and NaviCam Tether, NaviCam Xpress Stomach Capsule Endoscope System (NaviCam Xpress Stomach System) with NaviCam Stomach Capsule and NaviCam Tether K221608 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Anx Robotica Corp. Cleared Nov 2022. https://www.510kdatabase.net/k221624/ 2022-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k221624-avenda-health-ai-prostate-cancer-fda-510k.jpg K221624 - Avenda Health AI Prostate Cancer Planning Software K221624 is a FDA 510(k) cleared radiology medical device. Manufacturer: Avenda Health, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k221704/ 2022-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k221704-hemosphere-advanced-monitor-right-fda-510k.jpg K221704 - HemoSphere Advanced Monitor, Right Ventricular Pressure (RVP), Global Hypoperfusion Index (GHI) K221704 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Nov 2022. https://www.510kdatabase.net/k221716/ 2022-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k221716-cina-fda-510k.jpg K221716 - CINA K221716 is a FDA 510(k) cleared radiology medical device. Manufacturer: Avicenna.Ai. Cleared Nov 2022. https://www.510kdatabase.net/k221946/ 2022-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k221946-led-light-therapy-mask-model-mk66r-b-fda-510k.jpg K221946 - LED Light Therapy Mask (model: MK66R-B) K221946 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Light Tree Ventures Europe B.V.. Cleared Nov 2022. https://www.510kdatabase.net/k222009/ 2022-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k222009-aprevo-anterior-lumbar-interbody-fda-510k.jpg K222009 - aprevo® anterior lumbar interbody fusion device with interfixation K222009 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Carlsmed, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k222052/ 2022-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k222052-vitropro-fda-510k.jpg K222052 - VitroPRO K222052 is a FDA 510(k) cleared radiology medical device. Manufacturer: CIVCO Medical Instruments Co., Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k222054/ 2022-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k222054-dentiai-auto-chart-fda-510k.jpg K222054 - Denti.AI Auto-Chart K222054 is a FDA 510(k) cleared radiology medical device. Manufacturer: Denti.Ai Technology, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k222160/ 2022-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k222160-gus610-blood-pressure-monitor-fda-510k.jpg K222160 - GUS610 Blood pressure monitor K222160 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Globalcare Medical Technology Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k222237/ 2022-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k222237-cala-kiq-fda-510k.jpg K222237 - Cala kIQ K222237 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cala Health, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k222895/ 2022-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k222895-dynamiciq-fda-510k.jpg K222895 - DynamicIQ K222895 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems SCS. Cleared Nov 2022. https://www.510kdatabase.net/k222964/ 2022-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k222964-biopoly-lesser-toe-hemiarthroplasty-fda-510k.jpg K222964 - BioPoly Lesser Toe Hemiarthroplasty Implant K222964 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: BioPoly, LLC. Cleared Nov 2022. https://www.510kdatabase.net/k222992/ 2022-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k222992-iroot-bp-root-repair-material-fda-510k.jpg K222992 - iRoot BP Root Repair Material BioAggregate Paste K222992 is a FDA 510(k) cleared dental medical device. Manufacturer: Innovative Bioceramix, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k223041/ 2022-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k223041-renasys-edge-66803126-fda-510k.jpg K223041 - Renasys Edge (66803126) K223041 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew Medical Limited. Cleared Nov 2022. https://www.510kdatabase.net/k223080/ 2022-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k223080-da-vinci-x-surgical-system-is4200-da-fda-510k.jpg K223080 - da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000) K223080 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k223152/ 2022-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k223152-vision-2-evarvision-trackvision-2-fda-510k.jpg K223152 - Vision 2, EVARVision, TrackVision 2, HeartVision 2 K223152 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems SCS. Cleared Nov 2022. https://www.510kdatabase.net/k211358/ 2022-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k211358-implanter-incl-accessories-fda-510k.jpg K211358 - Implanter incl. Accessories K211358 is a FDA 510(k) cleared dental medical device. Manufacturer: Guilin Woodpecker Medical Instrument Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k212936/ 2022-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k212936-vision-monitor-moncvone-fda-510k.jpg K212936 - Vision Monitor- MonCvONE K212936 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Metrovision. Cleared Nov 2022. https://www.510kdatabase.net/k220846/ 2022-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k220846-core-snare-fda-510k.jpg K220846 - CORE-SNARE K220846 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Incore Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k221069/ 2022-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k221069-infusion-sets-for-single-use-with-fda-510k.jpg K221069 - Infusion Sets for Single Use with Needles K221069 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sichuan Prius Biotechnology Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k221075/ 2022-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k221075-infusion-sets-for-single-use-fda-510k.jpg K221075 - Infusion Sets for Single Use K221075 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sichuan Prius Biotechnology Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k221078/ 2022-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k221078-intravenous-needles-for-single-fda-510k.jpg K221078 - Intravenous Needles for Single Use,Safety Intravenous Needles for Single Use K221078 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sichuan Prius Biotechnology Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k221268/ 2022-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k221268-sr-1-skin-treatment-system-fda-510k.jpg K221268 - SR-1 Skin Treatment System K221268 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Avava, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k221811/ 2022-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k221811-vista-bc-sealer-fda-510k.jpg K221811 - Vista BC Sealer K221811 is a FDA 510(k) cleared dental medical device. Manufacturer: Inter-Med, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k222246/ 2022-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k222246-disposable-sterile-lancet-fda-510k.jpg K222246 - Disposable Sterile Lancet K222246 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Tianjin Rilifine Medical Device Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k222372/ 2022-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k222372-kowa-sl-19-fda-510k.jpg K222372 - Kowa SL-19 K222372 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Kowa Company , Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k222390/ 2022-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k222390-flex-thread-ulna-intramedullary-nail-fda-510k.jpg K222390 - Flex-Thread™ Ulna Intramedullary Nail System K222390 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Flower Orthopedics Corporation Dba Conventus Flower. Cleared Nov 2022. https://www.510kdatabase.net/k222420/ 2022-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k222420-disposable-blood-pressure-cuff-fda-510k.jpg K222420 - Disposable Blood Pressure Cuff K222420 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Wenzhou Xikang Medical Instruments Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k222645/ 2022-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k222645-treace-medical-concepts-tmc-implant-fda-510k.jpg K222645 - Treace Medical Concepts (TMC) Implant Fixation System K222645 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Treace Medical Concepts. Cleared Nov 2022. https://www.510kdatabase.net/k222951/ 2022-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k222951-sm-v-fda-510k.jpg K222951 - SM-V K222951 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sedecal., Sa.. Cleared Nov 2022. https://www.510kdatabase.net/k222980/ 2022-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k222980-pentax-medical-valve-set-fda-510k.jpg K222980 - Pentax Medical Valve Set K222980 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Yangzhou Fartley Medical Instrument Technology Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k223032/ 2022-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k223032-sis-system-version-560-fda-510k.jpg K223032 - SIS System (Version 5.6.0) K223032 is a FDA 510(k) cleared radiology medical device. Manufacturer: Surgical Information Sciences, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k223257/ 2022-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k223257-miro3d-wound-matrix-fda-510k.jpg K223257 - Miro3D Wound Matrix K223257 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Reprise Biomedical. Cleared Nov 2022. https://www.510kdatabase.net/k221165/ 2022-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k221165-non-sterile-powder-free-nitrile-fda-510k.jpg K221165 - Non-Sterile, Powder-Free Nitrile Examination Glove Violet Blue Tested for use with Chemotherapy Drugs and Fentanyl and Non-Sterile, Powder-Free Nitrile Examination Glove Blue Tested for use with Chemotherapy Drugs and Fentanyl K221165 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sri Trang Gloves (Thailand) Public Company Limited. Cleared Nov 2022. https://www.510kdatabase.net/k221282/ 2022-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k221282-empatica-health-monitoring-platform-fda-510k.jpg K221282 - Empatica Health Monitoring Platform K221282 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Empatica S.R.L.. Cleared Nov 2022. https://www.510kdatabase.net/k210623/ 2022-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k210623-flc-kappa-flc-lambda-flc-control-level-fda-510k.jpg K210623 - FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2 K210623 is a FDA 510(k) cleared immunology medical device. Manufacturer: Sebia. Cleared Nov 2022. https://www.510kdatabase.net/k212911/ 2022-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k212911-konig-mogen-clamp-fda-510k.jpg K212911 - Konig Mogen Clamp K212911 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Medline Industries, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k213018/ 2022-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k213018-auxilock-gfs-mini-gfs-ii-large-and-gfs-fda-510k.jpg K213018 - Auxilock GFS Mini, GFS II Large, and GFS Ultimate K213018 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Auxein Medical Private Limited. Cleared Nov 2022. https://www.510kdatabase.net/k220351/ 2022-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k220351-polso-watch-fda-510k.jpg K220351 - Polso Watch K220351 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Chronisense Medical, Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k220658/ 2022-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k220658-cosy-cervicothoracic-occipital-rod-fda-510k.jpg K220658 - COSY Cervicothoracic Occipital Rod-Screw System K220658 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Signus Medizintechnik GmbH. Cleared Nov 2022. https://www.510kdatabase.net/k221330/ 2022-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k221330-briefcase-fda-510k.jpg K221330 - BriefCase K221330 is a FDA 510(k) cleared radiology medical device. Manufacturer: Aidoc Medical , Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k221369/ 2022-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k221369-fbcc-night-guard-fda-510k.jpg K221369 - FBCC Night Guard K221369 is a FDA 510(k) cleared dental medical device. Manufacturer: Fbcc, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k221580/ 2022-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k221580-single-use-flexible-cystoscope-fda-510k.jpg K221580 - Single-Use Flexible Cystoscope K221580 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hunan Vathin Medical Instrument Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k221581/ 2022-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k221581-single-use-flexible-rhinolaryngoscope-fda-510k.jpg K221581 - Single-Use Flexible Rhinolaryngoscope K221581 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Hunan Vathin Medical Instrument Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k222189/ 2022-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k222189-sioxd-wound-matrix-fda-510k.jpg K222189 - SiOxD Wound Matrix K222189 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sioxmed, LLC. Cleared Nov 2022. https://www.510kdatabase.net/k222455/ 2022-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k222455-calibrate-ltx-interbody-system-fda-510k.jpg K222455 - Calibrate LTX Interbody System K222455 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k222477/ 2022-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k222477-hair-growth-device-fda-510k.jpg K222477 - Hair Growth Device K222477 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Dongguan Lescolton Medical Equipment Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k222493/ 2022-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k222493-coda-anterior-cervical-plate-system-fda-510k.jpg K222493 - CODA™ Anterior Cervical Plate System K222493 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Pioneer Surgical Technology, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k222496/ 2022-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k222496-electromed-smartvest-airway-clearance-fda-510k.jpg K222496 - Electromed SmartVest Airway Clearance System K222496 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Electromed, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k222535/ 2022-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k222535-ocs-lung-donor-flush-set-fda-510k.jpg K222535 - OCS Lung Donor Flush Set K222535 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: TransMedics, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k222539/ 2022-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k222539-facet-blood-lancets-fda-510k.jpg K222539 - Facet Blood Lancets K222539 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Facet Technologies, LLC. Cleared Nov 2022. https://www.510kdatabase.net/k222701/ 2022-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k222701-manta-laser-fda-510k.jpg K222701 - MANTA Laser K222701 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Squalus Med , Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k222816/ 2022-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k222816-opulent-tinbn-coated-knee-fda-510k.jpg K222816 - Opulent TiNbN Coated Knee K222816 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Meril Healthcare Pvt. , Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k222903/ 2022-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k222903-tailored-h-cervical-stand-alone-system-fda-510k.jpg K222903 - Tailored-H Cervical Stand Alone System K222903 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Bespoke Technologies, LLC. Cleared Nov 2022. https://www.510kdatabase.net/k223003/ 2022-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k223003-banded-face-mask-fda-510k.jpg K223003 - Banded Face Mask K223003 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hubei Medlink Healthcare Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k223124/ 2022-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k223124-expd-86p-expd-86pg-expd-129p-expd-129pg-fda-510k.jpg K223124 - EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG K223124 is a FDA 510(k) cleared radiology medical device. Manufacturer: DRTECH Corporation. Cleared Nov 2022. https://www.510kdatabase.net/k223246/ 2022-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k223246-hillrom-heart-and-respiration-rate-fda-510k.jpg K223246 - Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense K223246 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Baxter Healthcare Corproration. Cleared Nov 2022. https://www.510kdatabase.net/k223293/ 2022-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k223293-contour-next-gen-blood-glucose-fda-510k.jpg K223293 - CONTOUR® NEXT GEN Blood Glucose Monitoring System K223293 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Ascensia Diabetes Care U.S., Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k211265/ 2022-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k211265-tfx-lt2000-therapy-light-fda-510k.jpg K211265 - TFX-LT2000 Therapy Light K211265 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Toefx, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k212910/ 2022-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k212910-dental-high-speed-turbine-handpiece-fda-510k.jpg K212910 - Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece K212910 is a FDA 510(k) cleared dental medical device. Manufacturer: Shenzhen Carejoy Technology Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k213042/ 2022-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k213042-supra-non-stick-bipolar-forceps-fda-510k.jpg K213042 - Supra Non-Stick Bipolar Forceps K213042 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Guenter Bissinger Medizintechnik GmbH. Cleared Nov 2022. https://www.510kdatabase.net/k213295/ 2022-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k213295-cc-life-21-fda-510k.jpg K213295 - C.C. LIFE 21 K213295 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 21 Equipment S.R.L.. Cleared Nov 2022. https://www.510kdatabase.net/k220042/ 2022-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k220042-dentca-base-premium-dentca-base-hi-fda-510k.jpg K220042 - Dentca Base Premium, Dentca Base Hi-Impact K220042 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentca, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k220558/ 2022-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k220558-blood-administration-sets-fda-510k.jpg K220558 - Blood Administration Sets K220558 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corporation. Cleared Nov 2022. https://www.510kdatabase.net/k220739/ 2022-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k220739-disposable-urine-collection-tube-fda-510k.jpg K220739 - Disposable Urine Collection Tube K220739 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Zhejiang Gongdong Medical Technology Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k220820/ 2022-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k220820-parky-app-fda-510k.jpg K220820 - Parky App K220820 is a FDA 510(k) cleared neurology medical device. Manufacturer: H2o Bilisim Yazilim. Cleared Nov 2022. https://www.510kdatabase.net/k220905/ 2022-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k220905-xvision-spine-system-fda-510k.jpg K220905 - xvision Spine System K220905 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Augmedics, Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k221178/ 2022-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k221178-disposable-insulin-pen-needle-fda-510k.jpg K221178 - Disposable Insulin Pen Needle K221178 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ningbo Medsun Medical Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k221281/ 2022-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k221281-multitom-rax-fda-510k.jpg K221281 - Multitom Rax K221281 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions. Cleared Nov 2022. https://www.510kdatabase.net/k221479/ 2022-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k221479-persona-personalized-knee-system-fda-510k.jpg K221479 - Persona Personalized Knee System K221479 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k221593/ 2022-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k221593-cure-ultra-male-cure-ultra-female-cure-fda-510k.jpg K221593 - Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus K221593 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Convatec, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k222109/ 2022-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k222109-accure-laser-fda-510k.jpg K222109 - Accure Laser K222109 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Accure Acne, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k222208/ 2022-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k222208-hisense-lcd-monitor-hmd2c21a-hmd4c27s-fda-510k.jpg K222208 - Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D K222208 is a FDA 510(k) cleared radiology medical device. Manufacturer: Qingdao Hisense Medical Equipment Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k222476/ 2022-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k222476-omegaai-image-viewer-fda-510k.jpg K222476 - OmegaAI Image Viewer K222476 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ramsoft, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k222518/ 2022-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k222518-fx-contra-fda-510k.jpg K222518 - FX Contra K222518 is a FDA 510(k) cleared dental medical device. Manufacturer: Nakanishi, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k222598/ 2022-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k222598-ipl-hair-removal-device-fda-510k.jpg K222598 - IPL Hair Removal Device K222598 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Noble Smart Manufacturing Tech Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k222673/ 2022-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k222673-alexandrite-and-ndyag-laser-models-fda-510k.jpg K222673 - Alexandrite and Nd:YAG Laser models CANLASE and TORLASE K222673 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Canadian Pioneer Medical Technology Corporation (Cpmt Laser). Cleared Nov 2022. https://www.510kdatabase.net/k222973/ 2022-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k222973-identiti-and-transcend-interbody-fda-510k.jpg K222973 - IdentiTi and Transcend Interbody Systems: IndentiTi Cervical Porous Ti Interbody System, IdentiTi NanoTec Cervical Interbody System, Transcend Cervical PEEK Interbody System, Transcend NanoTec Cervical Interbody System, IdentiTi Cervical Standalone Interbody System, IdentiTi NanoTec Cervical Standalone Interbody Sytem K222973 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k223227/ 2022-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k223227-maven-patient-specific-instrumentation-fda-510k.jpg K223227 - MAVEN™ Patient-Specific Instrumentation K223227 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paragon 28, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k223267/ 2022-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k223267-skr-3000-fda-510k.jpg K223267 - SKR 3000 K223267 is a FDA 510(k) cleared radiology medical device. Manufacturer: Konica Minolta, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k223278/ 2022-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k223278-easy-claire-fda-510k.jpg K223278 - easy Claire K223278 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Y & J Bio Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k203528/ 2022-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k203528-knh-surgical-face-mask-fda-510k.jpg K203528 - KNH Surgical Face Mask K203528 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Knh Surgical Face Mask. Cleared Nov 2022. https://www.510kdatabase.net/k212812/ 2022-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k212812-surgical-gown-fda-510k.jpg K212812 - Surgical Gown K212812 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Xianning Marveldas Protective Articles Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k220302/ 2022-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k220302-disposable-surgical-face-mask-fda-510k.jpg K220302 - Disposable surgical face mask K220302 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shandong Aida Medical Products Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k220465/ 2022-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k220465-pentax-medical-epk-3000-imaging-system-fda-510k.jpg K220465 - PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-J10 K220465 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Pentax of America, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k220533/ 2022-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k220533-endoscopy-oxygen-mask-fda-510k.jpg K220533 - Endoscopy Oxygen Mask K220533 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Engineered Medical Systems, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k220635/ 2022-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k220635-heater-cooler-system-3t-fda-510k.jpg K220635 - Heater-Cooler System 3T K220635 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Livanova Deutschland, GmbH. Cleared Nov 2022. https://www.510kdatabase.net/k220841/ 2022-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k220841-primetaper-ev-dental-implants-30-ds-fda-510k.jpg K220841 - PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS) K220841 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona. Cleared Nov 2022. https://www.510kdatabase.net/k221094/ 2022-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k221094-omnitaper-ev-dental-implants-ds-fda-510k.jpg K221094 - OmniTaper EV Dental Implants, DS Implants abutments with EV connection K221094 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona. Cleared Nov 2022. https://www.510kdatabase.net/k221762/ 2022-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k221762-bonemri-v14-fda-510k.jpg K221762 - BoneMRI v1.4 K221762 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mrlguidance B.V.. Cleared Nov 2022. https://www.510kdatabase.net/k222364/ 2022-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k222364-xtrallux-alpha-xa136r-usa-xtrallux-fda-510k.jpg K222364 - Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA), Xtrallux Turbo Pro (XP316R-USA), Xtrallux Extreme RX (XR352R-USA) K222364 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Xtrallux, LLC. Cleared Nov 2022. https://www.510kdatabase.net/k222628/ 2022-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k222628-life-spine-alif-buttress-plate-system-fda-510k.jpg K222628 - Life Spine ALIF Buttress Plate System K222628 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k211830/ 2022-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k211830-lifesparc-system-fda-510k.jpg K211830 - LifeSPARC System K211830 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cardiacassist, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k212612/ 2022-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k212612-omnia-medical-tibrid-sc-fda-510k.jpg K212612 - Omnia Medical TiBrid-SC K212612 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Omnia Medical, LLC. Cleared Nov 2022. https://www.510kdatabase.net/k212700/ 2022-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k212700-dyflex-ii-fda-510k.jpg K212700 - Dyflex-II K212700 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Taeyeon Medical Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k220535/ 2022-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k220535-cardio10-fda-510k.jpg K220535 - Cardio10 K220535 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bionet Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k221558/ 2022-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k221558-alphalok-plating-system-fda-510k.jpg K221558 - ALPHALOK Plating System K221558 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Vilex, LLC. Cleared Nov 2022. https://www.510kdatabase.net/k221722/ 2022-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k221722-haemonetics-cell-saver-eliteelite-fda-510k.jpg K221722 - Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) K221722 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Haemonetics Corporation. Cleared Nov 2022. https://www.510kdatabase.net/k221744/ 2022-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k221744-stratafix-spiral-monocryl-plus-fda-510k.jpg K221744 - STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device K221744 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k222055/ 2022-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k222055-disposable-sterile-lancet-fda-510k.jpg K222055 - Disposable Sterile Lancet K222055 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Tianjin Rilifine Medical Device Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k222175/ 2022-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k222175-bloomi-delight-oil-based-personal-fda-510k.jpg K222175 - Bloomi Delight Oil-Based Personal Lubricant K222175 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: The Bloomi Inc... Cleared Nov 2022. https://www.510kdatabase.net/k222309/ 2022-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k222309-gamma4-system-fda-510k.jpg K222309 - Gamma4 System K222309 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker GmbH. Cleared Nov 2022. https://www.510kdatabase.net/k222488/ 2022-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k222488-everyway-analog-otc-tens-fda-510k.jpg K222488 - Everyway Analog OTC TENS K222488 is a FDA 510(k) cleared neurology medical device. Manufacturer: Everyway Medical Instruments Co.,Ltd. Cleared Nov 2022. https://www.510kdatabase.net/k222564/ 2022-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k222564-treace-medical-concepts-tmc-hammertoe-fda-510k.jpg K222564 - Treace Medical Concepts (TMC) Hammertoe Fixation System K222564 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Treace Medical Concepts, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k222915/ 2022-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k222915-quadruple-laser-system-models-cpmt-fda-510k.jpg K222915 - Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE PLUS K222915 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Canadian Pioneer Medical Technology Corporation (Cpmt Laser). Cleared Nov 2022. https://www.510kdatabase.net/k223199/ 2022-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k223199-21-x-255mm-drill-22mm-stop-fda-510k.jpg K223199 - 2.1 x 255mm Drill, 22mm Stop K223199 is a FDA 510(k) cleared neurology medical device. Manufacturer: Biomet Microfixation. Cleared Nov 2022. https://www.510kdatabase.net/k210980/ 2022-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k210980-smith-nephew-intramedullary-nail-systems-fda-510k.jpg K210980 - Smith & Nephew Intramedullary Nail Systems K210980 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k213217/ 2022-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k213217-disposable-hemoclip-fda-510k.jpg K213217 - Disposable hemoclip K213217 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Beijing Zksk Technology Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k220326/ 2022-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k220326-posisep-x-bam-hemostat-fda-510k.jpg K220326 - PosiSep X BAM Hemostat Dressing/Intranasal Splint K220326 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Hemostasis, LLC. Cleared Nov 2022. https://www.510kdatabase.net/k221578/ 2022-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k221578-hexanium-acif-fda-510k.jpg K221578 - Hexanium ACIF K221578 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinevision, S.A.S.. Cleared Nov 2022. https://www.510kdatabase.net/k221655/ 2022-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k221655-multiflex-steerable-sheath-fda-510k.jpg K221655 - Multiflex Steerable Sheath K221655 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vizaramed, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k222428/ 2022-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k222428-syngo-dynamics-version-va40f-fda-510k.jpg K222428 - Syngo Dynamics (Version VA40F) K222428 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k222480/ 2022-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k222480-standard-surgical-gown-aami-level-2-fda-510k.jpg K222480 - Standard Surgical Gown (AAMI Level 2) K222480 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Foshan Nanhai Plus Medical Co, Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k222490/ 2022-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k222490-hbl-blade-assembly-fda-510k.jpg K222490 - HBL Blade Assembly K222490 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Hand Biomechanics Lab, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k222520/ 2022-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k222520-zirconia-block-fda-510k.jpg K222520 - Zirconia Block K222520 is a FDA 510(k) cleared dental medical device. Manufacturer: Yilink (Tianjin) Biotechnology Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k222529/ 2022-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k222529-surgical-face-mask-fda-510k.jpg K222529 - Surgical Face Mask K222529 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Xiantao Rayxin Medical Products Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k222540/ 2022-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k222540-upmr-790-fda-510k.jpg K222540 - uPMR 790 K222540 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k222749/ 2022-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k222749-high-fluid-resistant-surgical-and-fda-510k.jpg K222749 - High Fluid-Resistant Surgical and Procedure Mask K222749 is a FDA 510(k) cleared general hospital medical device. Manufacturer: America?S Supply Chains. Cleared Nov 2022. https://www.510kdatabase.net/k213981/ 2022-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k213981-nitrile-examination-gloves-fda-510k.jpg K213981 - Nitrile Examination Gloves K213981 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Emerald Glove Manufacturing Sdn Bhd. Cleared Nov 2022. https://www.510kdatabase.net/k212164/ 2022-11-11 monthly 0.5 https://www.510kdatabase.net/og-image/k212164-mapping-suction-probe-fda-510k.jpg K212164 - Mapping Suction Probe K212164 is a FDA 510(k) cleared neurology medical device. Manufacturer: Inomed Medizintechnik GmbH. Cleared Nov 2022. https://www.510kdatabase.net/k220983/ 2022-11-11 monthly 0.5 https://www.510kdatabase.net/og-image/k220983-imsonic-tr-1-ultrasonic-pulsed-doppler-fda-510k.jpg K220983 - ImSonic TR-1 Ultrasonic Pulsed Doppler Imaging System K220983 is a FDA 510(k) cleared radiology medical device. Manufacturer: Imsonic Medical China, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k222225/ 2022-11-11 monthly 0.5 https://www.510kdatabase.net/og-image/k222225-nitrile-powder-free-examination-glove-fda-510k.jpg K222225 - Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Blue) K222225 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hartalega NGC Sdn. Bhd.. Cleared Nov 2022. https://www.510kdatabase.net/k211934/ 2022-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k211934-apdl-drainage-catheter-system-flexima-fda-510k.jpg K211934 - APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL Drainage Catheter System Kit with Dissolving Tip, Flexima APDL Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System, Flexima APD Drainage Catheter System Kit, Flexima APD Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System Kit with Dissolving Tip, Flexima Quickstick Drainage Catheter System, vanSonnenberg Drainage Cateter System, vanSonnenberg K211934 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Nov 2022. https://www.510kdatabase.net/k211954/ 2022-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k211954-subdural-electrode-stripintraoperative-fda-510k.jpg K211954 - Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid K211954 is a FDA 510(k) cleared neurology medical device. Manufacturer: Spes Medica Srl. Cleared Nov 2022. https://www.510kdatabase.net/k213294/ 2022-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k213294-dermal-cooling-system-fda-510k.jpg K213294 - Dermal Cooling System K213294 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: R2 Technologies, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k220230/ 2022-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k220230-amsure-enteral-feeding-pump-fda-510k.jpg K220230 - AMSure Enteral Feeding Pump K220230 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Amsino International, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k220360/ 2022-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k220360-tandry-cmf-plate-system-fda-510k.jpg K220360 - Tandry CMF Plate System K220360 is a FDA 510(k) cleared dental medical device. Manufacturer: Microware Precision Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k220408/ 2022-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k220408-aview-rt-acs-fda-510k.jpg K220408 - AVIEW RT ACS K220408 is a FDA 510(k) cleared radiology medical device. Manufacturer: Coreline Soft Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k220562/ 2022-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k220562-tigen-abutment-zrgen-abutment-and-scan-fda-510k.jpg K220562 - TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment K220562 is a FDA 510(k) cleared dental medical device. Manufacturer: Megagen Implant Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k220794/ 2022-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k220794-10pl-fda-510k.jpg K220794 - 10PL K220794 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Tentech Co. , Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k220957/ 2022-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k220957-fujifilm-endoscope-model-eb-710p-fda-510k.jpg K220957 - FUJIFILM Endoscope Model EB-710P K220957 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Fujifilm Corporaton. Cleared Nov 2022. https://www.510kdatabase.net/k221139/ 2022-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k221139-bodygard-sfs-surgical-gown-level-4-fda-510k.jpg K221139 - Bodygard SFS Surgical Gown Level 4 K221139 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Feliks Plastik Laminasyon VE Ambalaj Malzemeleri. Cleared Nov 2022. https://www.510kdatabase.net/k221183/ 2022-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k221183-aeye-ds-fda-510k.jpg K221183 - AEYE-DS K221183 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Aeye Health, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k221225/ 2022-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k221225-access-tsh-3rd-is-assay-dxi-9000-fda-510k.jpg K221225 - Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer K221225 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k221391/ 2022-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k221391-wolf-thrombectomy-smartclaw-catheter-fda-510k.jpg K221391 - WOLF Thrombectomy™ SmartClaw Catheter K221391 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Devoro Medical, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k221677/ 2022-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k221677-synapse-3d-base-tools-v66-fda-510k.jpg K221677 - Synapse 3D Base Tools v6.6 K221677 is a FDA 510(k) cleared radiology medical device. Manufacturer: Fujifilm Corporation. Cleared Nov 2022. https://www.510kdatabase.net/k221678/ 2022-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k221678-sprintray-high-impact-denture-base-fda-510k.jpg K221678 - SprintRay High Impact Denture Base K221678 is a FDA 510(k) cleared dental medical device. Manufacturer: Sprintray, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k222061/ 2022-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k222061-dental-lt-clear-v2-resin-fda-510k.jpg K222061 - Dental LT Clear V2 Resin K222061 is a FDA 510(k) cleared dental medical device. Manufacturer: Formlabs Ohio, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k222067/ 2022-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k222067-sc-hemodialysis-device-sc-dialysate-fda-510k.jpg K222067 - SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood Tube Set K222067 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quanta Dialysis Technologies, Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k222317/ 2022-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k222317-catalyst-ea-convertible-stemmed-shoulder-fda-510k.jpg K222317 - Catalyst EA Convertible Stemmed Shoulder K222317 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Catalyst Orthoscience, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k222475/ 2022-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k222475-snor-lock-fda-510k.jpg K222475 - SNOR LOCK K222475 is a FDA 510(k) cleared dental medical device. Manufacturer: Solbaro Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k222504/ 2022-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k222504-h1-fda-510k.jpg K222504 - H1 K222504 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k222551/ 2022-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k222551-humask-pro-vision-humask-pro-vision-3000-fda-510k.jpg K222551 - Humask Pro Vision, Humask Pro Vision 3000 K222551 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Entreprise Premont, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k222667/ 2022-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k222667-wisdiag-multi-drug-urine-test-cup-fda-510k.jpg K222667 - Wisdiag Multi-Drug Urine Test Cup, Wisdiag Multi-Drug Urine Test Cup Rx K222667 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Vivachek Biotech (Hangzhou) Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k223171/ 2022-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k223171-aquapulse-irrigation-tubing-fda-510k.jpg K223171 - AquaPulse® Irrigation Tubing K223171 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ga Health Company Limited. Cleared Nov 2022. https://www.510kdatabase.net/k223185/ 2022-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k223185-breathid-smart-system-fda-510k.jpg K223185 - BreathID® Smart System K223185 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Meridian Bioscience Israel , Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k223198/ 2022-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k223198-bd-intraosseous-vascular-access-system-fda-510k.jpg K223198 - BD Intraosseous Vascular Access System EMS Powered Driver (D001003) K223198 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bard Access Systems. Cleared Nov 2022. https://www.510kdatabase.net/k203035/ 2022-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k203035-eonis-scid-sma-kit-fda-510k.jpg K203035 - Eonis SCID-SMA kit K203035 is a FDA 510(k) cleared medical genetics medical device. Manufacturer: Perkinelmer, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k220334/ 2022-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k220334-monet-anterior-cervical-plate-system-fda-510k.jpg K220334 - MONET Anterior Cervical Plate System K220334 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ctl Medical Corporation. Cleared Nov 2022. https://www.510kdatabase.net/k221539/ 2022-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k221539-gammatile-fda-510k.jpg K221539 - GammaTile K221539 is a FDA 510(k) cleared radiology medical device. Manufacturer: Gt Medical Technologies. Cleared Nov 2022. https://www.510kdatabase.net/k221855/ 2022-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k221855-universal-cmf-system-fda-510k.jpg K221855 - Universal CMF System K221855 is a FDA 510(k) cleared dental medical device. Manufacturer: Stryker Leibinger GmbH & Co KG. Cleared Nov 2022. https://www.510kdatabase.net/k222162/ 2022-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k222162-flexible-cystoscope-model-cy50h-20eu-fda-510k.jpg K222162 - Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US) K222162 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Shanghai AnQing Medical Instrument Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k222166/ 2022-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k222166-solix-fda-510k.jpg K222166 - SOLIX K222166 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Optovue, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k222198/ 2022-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k222198-exo-iris-el2001-fda-510k.jpg K222198 - Exo Iris (El2001) K222198 is a FDA 510(k) cleared radiology medical device. Manufacturer: Exo Imaging, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k222497/ 2022-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k222497-zaga-zygomatic-system-fda-510k.jpg K222497 - Zaga Zygomatic System K222497 is a FDA 510(k) cleared dental medical device. Manufacturer: Southern Implants (Pty), Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k222754/ 2022-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k222754-viewmate-multi-ultrasound-system-fda-510k.jpg K222754 - ViewMate Multi Ultrasound System K222754 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k223132/ 2022-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k223132-iridex-pascal-532-iridex-pascal-577-fda-510k.jpg K223132 - Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models) K223132 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Iridex Corporation. Cleared Nov 2022. https://www.510kdatabase.net/den200044/ 2022-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/den200044-eonis-scid-sma-kit-fda-510k.jpg DEN200044 - Eonis SCID-SMA Kit DEN200044 is a FDA 510(k) cleared medical genetics medical device. Manufacturer: Perkinelmer, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k203812/ 2022-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k203812-oxyfit-pulse-oximeter-fda-510k.jpg K203812 - Oxyfit Pulse Oximeter K203812 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Viatom Technology Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k210346/ 2022-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k210346-sysmex-xw-100-automated-hematology-fda-510k.jpg K210346 - Sysmex XW-100 Automated Hematology Analyzer K210346 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sysmex America, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k221552/ 2022-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k221552-efai-chestsuite-xr-pneumothorax-fda-510k.jpg K221552 - EFAI ChestSuite XR Pneumothorax Assessment System K221552 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ever Fortune.Ai, Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k222132/ 2022-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k222132-hisense-lcd-monitor-hmd2g21s-hmd3g21s-fda-510k.jpg K222132 - Hisense LCD monitor HMD2G21S, HMD3G21S K222132 is a FDA 510(k) cleared radiology medical device. Manufacturer: Qingdao Hisense Medical Equipment Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k222304/ 2022-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k222304-sonata-transcervical-fibroid-ablation-fda-510k.jpg K222304 - Sonata Transcervical Fibroid Ablation System 2.2 K222304 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Gynesonics, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k222734/ 2022-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k222734-diversatek-healthcare-pureflo-fda-510k.jpg K222734 - Diversatek Healthcare PureFlo Irrigation System / Water Bottle Tubing K222734 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Diversatek Healthcare. Cleared Nov 2022. https://www.510kdatabase.net/k223178/ 2022-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k223178-selectsite-c304-deflectable-catheter-fda-510k.jpg K223178 - SelectSite C304 Deflectable Catheter System, C315 Delivery System K223178 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic. Cleared Nov 2022. https://www.510kdatabase.net/k212317/ 2022-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k212317-eclipse-mini-model-98900-fda-510k.jpg K212317 - Eclipse MINI Model 98900 K212317 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Spacelabs Healthcare, Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k220346/ 2022-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k220346-lotus-prophy-angle-fda-510k.jpg K220346 - Lotus Prophy Angle K220346 is a FDA 510(k) cleared dental medical device. Manufacturer: Ajk Engineering, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k220489/ 2022-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k220489-durex-patronus-closefit-durex-patronus-fda-510k.jpg K220489 - Durex Patronus CloseFit, Durex Patronus Regular K220489 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Rb Health (Us), LLC. Cleared Nov 2022. https://www.510kdatabase.net/k220874/ 2022-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k220874-smooth-drive-contra-angle-and-straight-fda-510k.jpg K220874 - Smooth Drive contra angle and straight handpieces K220874 is a FDA 510(k) cleared dental medical device. Manufacturer: Lares Research. Cleared Nov 2022. https://www.510kdatabase.net/k221833/ 2022-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k221833-hemosphere-advanced-monitor-hemosphere-fda-510k.jpg K221833 - HemoSphere Advanced Monitor, HemoSphere ClearSight Module K221833 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Nov 2022. https://www.510kdatabase.net/k222679/ 2022-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k222679-vericor-support-catheter-fda-510k.jpg K222679 - Vericor Support Catheter K222679 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vascupatent Medical (Shenzhen) Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k222732/ 2022-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k222732-waveform-a-interbody-system-fda-510k.jpg K222732 - WaveForm A Interbody System K222732 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared Nov 2022. https://www.510kdatabase.net/k222741/ 2022-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k222741-denu-light-bodyregular-fast-denu-heavy-fda-510k.jpg K222741 - DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast) K222741 is a FDA 510(k) cleared dental medical device. Manufacturer: Hdi, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k222800/ 2022-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k222800-diode-laser-hair-removal-systems-for-fda-510k.jpg K222800 - Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A) K222800 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sanhe Laserconn Tech Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k222873/ 2022-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k222873-attain-command-surevalve-delivery-fda-510k.jpg K222873 - Attain Command + SureValve Delivery System, Attain Select II + SureValve delivery system K222873 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic. Cleared Nov 2022. https://www.510kdatabase.net/k222898/ 2022-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k222898-safesource-direct-blue-powder-free-fda-510k.jpg K222898 - SafeSource Direct Blue Powder-Free Nitrile Exam Gloves K222898 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Safesource Direct, LLC. Cleared Nov 2022. https://www.510kdatabase.net/k222936/ 2022-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k222936-humeris-135-shoulder-system-fda-510k.jpg K222936 - Humeris® 135 Shoulder System K222936 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Fx Shoulder USA, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k223127/ 2022-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k223127-hemosphere-advanced-monitoring-fda-510k.jpg K223127 - HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable K223127 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifeciences, LLC. Cleared Nov 2022. https://www.510kdatabase.net/k202755/ 2022-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k202755-simplexa-congenital-cmv-direct-and-fda-510k.jpg K202755 - Simplexa Congenital CMV Direct and Simplexa Congenital CMV Positive Control Pack K202755 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Diasorin Molecular, LLC. Cleared Nov 2022. https://www.510kdatabase.net/k201256/ 2022-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k201256-procise-crp-procisedx-analyzer-fda-510k.jpg K201256 - Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartridge K201256 is a FDA 510(k) cleared immunology medical device. Manufacturer: Procise Diagnostics. Cleared Nov 2022. https://www.510kdatabase.net/k212764/ 2022-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k212764-medwell-technology-ltd-syringes-fda-510k.jpg K212764 - Medwell Technology Ltd Syringes, various sizes K212764 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medwell Technology, Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k213108/ 2022-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k213108-humerus-ulna-system-fda-510k.jpg K213108 - Humerus & Ulna System K213108 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Auxein Medical Private Limited. Cleared Nov 2022. https://www.510kdatabase.net/k220421/ 2022-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k220421-bgm039-blood-glucose-monitoring-system-fda-510k.jpg K220421 - BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System K220421 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Apex BioTechnology Corp.. Cleared Nov 2022. https://www.510kdatabase.net/k220833/ 2022-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k220833-citregen-tendon-interference-screw-fda-510k.jpg K220833 - Citregen Tendon Interference Screw, Citrelock, Citrefix, Citrespline ACL, and Citrelock ACL K220833 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Acuitive Technologies, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k221007/ 2022-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k221007-cobas-hcv-fda-510k.jpg K221007 - cobas HCV K221007 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Molecular Systems, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k221086/ 2022-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k221086-cryorobot-select-system-fda-510k.jpg K221086 - CryoRobot Select System K221086 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Tmrw Life Sciences, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k221162/ 2022-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k221162-univy-osteovy-cervical-ibf-system-fda-510k.jpg K221162 - UniVy OsteoVy Cervical IBF System K221162 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Vy Spine, LLC. Cleared Nov 2022. https://www.510kdatabase.net/k221610/ 2022-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k221610-nextra-ch-cannulated-hammertoe-system-fda-510k.jpg K221610 - Nextra CH Cannulated Hammertoe System K221610 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nextremity Solutions, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k221659/ 2022-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k221659-luminopia-one-fda-510k.jpg K221659 - Luminopia One K221659 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Luminopia, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k221675/ 2022-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k221675-united-u2-femoral-head-22mm-delta-fda-510k.jpg K221675 - United U2 femoral head, 22mm delta ceramic head K221675 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: United Orthopedic Corporation. Cleared Nov 2022. https://www.510kdatabase.net/k221822/ 2022-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k221822-benchmark-bmx81-access-system-fda-510k.jpg K221822 - BENCHMARK BMX81 Access System K221822 is a FDA 510(k) cleared neurology medical device. Manufacturer: Penumbra, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k222049/ 2022-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k222049-yomi-robotic-system-fda-510k.jpg K222049 - Yomi Robotic System K222049 is a FDA 510(k) cleared dental medical device. Manufacturer: Neocis, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k222124/ 2022-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k222124-sterile-hypodermic-syringe-withwithout-fda-510k.jpg K222124 - Sterile Hypodermic Syringe with/without Needle, Hypodermic Needle K222124 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k222453/ 2022-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k222453-self-adhesive-electrode-fda-510k.jpg K222453 - Self-adhesive Electrode K222453 is a FDA 510(k) cleared neurology medical device. Manufacturer: Guangdong Comytens Medical Technology Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k222639/ 2022-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k222639-vha-radiotherapy-bolus-fda-510k.jpg K222639 - VHA Radiotherapy Bolus K222639 is a FDA 510(k) cleared radiology medical device. Manufacturer: Vha Dean. Cleared Nov 2022. https://www.510kdatabase.net/k222697/ 2022-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k222697-disposable-medical-face-mask-df3-001-fda-510k.jpg K222697 - Disposable Medical Face Mask (DF3-001) K222697 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wellmed Dental Medical Supply Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k223062/ 2022-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k223062-world-total-knee-system-fda-510k.jpg K223062 - World Total Knee System K223062 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Signature Orthopaedics Pty, Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k223164/ 2022-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k223164-aquilo-sports-cct1500-system-fda-510k.jpg K223164 - Aquilo Sports CCT1500 System K223164 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aquilo Sports, LLC. Cleared Nov 2022. https://www.510kdatabase.net/k220263/ 2022-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k220263-vortex-surgical-laser-probes-vortex-fda-510k.jpg K220263 - Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgical Chandeliers K220263 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Vortex Surgical, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k220466/ 2022-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k220466-ibiomedi-electronic-stethoscope-es-2020-fda-510k.jpg K220466 - ibiomedi Electronic Stethoscope ES-2020 K220466 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sound Land Corp.. Cleared Nov 2022. https://www.510kdatabase.net/k221045/ 2022-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k221045-insulin-syringes-without-needle-fda-510k.jpg K221045 - Insulin Syringes without needle K221045 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Berpu Medical Technology Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k221518/ 2022-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k221518-np-medical-ncompass-extension-set-with-fda-510k.jpg K221518 - NP Medical nCompass Extension Set with Stabilizing Base K221518 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Np Medical. Cleared Nov 2022. https://www.510kdatabase.net/k221719/ 2022-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k221719-abtross-alif-expandable-cage-system-fda-510k.jpg K221719 - ABTross ALIF Expandable Cage System K221719 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aegis Spine, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k222107/ 2022-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k222107-black-diamond-poct-spinal-system-fda-510k.jpg K222107 - Black Diamond™ POCT Spinal System K222107 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osseus Fusion Systems. Cleared Nov 2022. https://www.510kdatabase.net/k222168/ 2022-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k222168-unistik-tinytouch-sterile-single-use-fda-510k.jpg K222168 - Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie and Full-Term, Unistik Heelstik Sterile Single-Use Heel Incision Safety Lancets - MicroPreemie, Preemie, Full-Term and Toddler K222168 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Owen Mumford, Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k222377/ 2022-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k222377-led-mask-platinum-md-fda-510k.jpg K222377 - Led Mask Platinum Md K222377 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cellreturn Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k223110/ 2022-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k223110-trusculpt-id-fda-510k.jpg K223110 - truSculpt iD K223110 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cutera, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k223355/ 2022-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k223355-tera-harz-clear-fda-510k.jpg K223355 - Tera Harz Clear K223355 is a FDA 510(k) cleared dental medical device. Manufacturer: Graphy, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k211816/ 2022-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k211816-brightway-brand-nitrile-examination-fda-510k.jpg K211816 - Brightway Brand, Nitrile Examination Gloves, Powder Free (Blue) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate K211816 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Brightway Holdings Sdn. Bhd.. Cleared Nov 2022. https://www.510kdatabase.net/k220371/ 2022-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k220371-nitrile-two-toned-bluegreen-powder-fda-510k.jpg K220371 - Nitrile Two Toned Blue/Green, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves, Tested for Use with the Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit) K220371 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Summit Glove, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k221184/ 2022-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k221184-origo-system-fda-510k.jpg K221184 - ORiGO System K221184 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Bien-Air Surgery SA. Cleared Nov 2022. https://www.510kdatabase.net/k222084/ 2022-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k222084-onetouch-delica-safety-hemocue-safety-fda-510k.jpg K222084 - OneTouch Delica Safety, HemoCue Safety Lancet, Assure Lance and Assure Lance Plus, Capiject Safety Lancet, Heel Lancet Newborn, Heel Lancet Preemie K222084 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Asahi Polyslider Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k222395/ 2022-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k222395-tango-neo-tango-reflex-neo-ultra-q-fda-510k.jpg K222395 - Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo K222395 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Ellex Medical Pty, Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k223320/ 2022-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k223320-powder-free-nitrile-examination-gloves-fda-510k.jpg K223320 - Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate K223320 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Lingshi Hongruida Health Protection Technology Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k214090/ 2022-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k214090-back-3-color-fda-510k.jpg K214090 - Back 3 COLOR K214090 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Swims America Corp. Cleared Nov 2022. https://www.510kdatabase.net/k220539/ 2022-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k220539-klarity-srs-baseplate-klarity-promise-fda-510k.jpg K220539 - Klarity SRS Baseplate, Klarity Promise Baseplate K220539 is a FDA 510(k) cleared radiology medical device. Manufacturer: Klarity Medical & Equipment (GZ) Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k221247/ 2022-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k221247-sterile-disposable-syringe-with-safety-fda-510k.jpg K221247 - Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Safety Needle, Sterile Disposable Needle K221247 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Kangbao Medical Equipment Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k221478/ 2022-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k221478-dolphin-blue-imaging-fda-510k.jpg K221478 - Dolphin Blue Imaging K221478 is a FDA 510(k) cleared radiology medical device. Manufacturer: Patterson Dental Supply, Inc.. Cleared Nov 2022. https://www.510kdatabase.net/k222258/ 2022-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k222258-combined-high-frequency-x-ray-source-fda-510k.jpg K222258 - Combined High Frequency X-ray Source K222258 is a FDA 510(k) cleared radiology medical device. Manufacturer: Suzhou Powersite Electric Co., Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k222508/ 2022-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k222508-3m-comply-hydrogen-peroxide-chemical-fda-510k.jpg K222508 - 3M™ Comply™ Hydrogen Peroxide Chemical Indicator 1248 K222508 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Nov 2022. https://www.510kdatabase.net/k222550/ 2022-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k222550-current-health-system-fda-510k.jpg K222550 - Current Health System K222550 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Current Health , Ltd.. Cleared Nov 2022. https://www.510kdatabase.net/k223270/ 2022-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k223270-pose-health-care-surgical-mask-fda-510k.jpg K223270 - POSE™ Health Care Surgical Mask K223270 is a FDA 510(k) cleared general hospital medical device. Manufacturer: America?S Supply Chains. Cleared Nov 2022. https://www.510kdatabase.net/k213697/ 2022-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k213697-origo-system-fda-510k.jpg K213697 - ORiGO System K213697 is a FDA 510(k) cleared neurology medical device. Manufacturer: Bien-Air Surgery SA. Cleared Oct 2022. https://www.510kdatabase.net/k220890/ 2022-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k220890-io-needle-safety-sheath-fda-510k.jpg K220890 - IO Needle Safety Sheath K220890 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Actuated Medical, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k220929/ 2022-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k220929-excelsior-fda-510k.jpg K220929 - Excelsior K220929 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Merit Cro, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k221810/ 2022-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k221810-lenshooke-ca1-sperm-separation-device-fda-510k.jpg K221810 - LensHooke CA1 Sperm Separation Device, LensHooke CA0 Sperm Separation Device K221810 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Bonraybio Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k222085/ 2022-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k222085-standard-tapered-bougie-38-fr-fda-510k.jpg K222085 - Standard Tapered Bougie, 38 Fr. K222085 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Standard Bariatrics, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k222318/ 2022-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k222318-fresenius-liberty-select-cycler-fda-510k.jpg K222318 - Fresenius Liberty Select Cycler K222318 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC. Cleared Oct 2022. https://www.510kdatabase.net/k222717/ 2022-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k222717-cl24n-fda-510k.jpg K222717 - CL24N K222717 is a FDA 510(k) cleared radiology medical device. Manufacturer: Wide Corporation. Cleared Oct 2022. https://www.510kdatabase.net/k222722/ 2022-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k222722-cw60n-fda-510k.jpg K222722 - CW60N K222722 is a FDA 510(k) cleared radiology medical device. Manufacturer: Wide Corporation. Cleared Oct 2022. https://www.510kdatabase.net/k221064/ 2022-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k221064-nuheara-iqbuds-2-pro-hearing-aid-fda-510k.jpg K221064 - Nuheara IQbuds 2 PRO Hearing Aid K221064 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Nuheara Limited. Cleared Oct 2022. https://www.510kdatabase.net/k211060/ 2022-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k211060-disposable-surgical-gown-rk-3011c-fda-510k.jpg K211060 - Disposable Surgical Gown Rk-3011C K211060 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Xiantao Rhycom Non-Woven Products Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k212473/ 2022-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k212473-welch-allyn-connex-central-station-fda-510k.jpg K212473 - Welch Allyn Connex Central Station K212473 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Welch Allyn, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k214109/ 2022-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k214109-peek-patient-specific-fda-510k.jpg K214109 - PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) K214109 is a FDA 510(k) cleared neurology medical device. Manufacturer: Kontour(Xi?An) Medical Technology Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k220305/ 2022-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k220305-syntheon-laa-exclusion-system-syntheon-fda-510k.jpg K220305 - Syntheon LAA Exclusion System, Syntheon LAA Selection Guide K220305 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Syntheon. Cleared Oct 2022. https://www.510kdatabase.net/k220869/ 2022-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k220869-vapotherm-aerosol-adapter-aaa-2-fda-510k.jpg K220869 - Vapotherm Aerosol Adapter AAA-2 K220869 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Vapotherm, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k221406/ 2022-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k221406-vented-vial-transfer-pin-fda-510k.jpg K221406 - Vented Vial Transfer Pin K221406 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Caina Medical Co.,Ltd. Cleared Oct 2022. https://www.510kdatabase.net/k221435/ 2022-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k221435-supertilt-plus-stp-fda-510k.jpg K221435 - SUPERTILT PLUS (STP) K221435 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Power Plus Mobility. Cleared Oct 2022. https://www.510kdatabase.net/k221521/ 2022-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k221521-disposable-safety-lancet-fda-510k.jpg K221521 - Disposable Safety Lancet K221521 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: SteriLance Medical (Suzhou), Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k221667/ 2022-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k221667-non-sterile-powder-free-latex-fda-510k.jpg K221667 - Non Sterile Powder Free Latex Examination Glove K221667 is a FDA 510(k) cleared general hospital medical device. Manufacturer: New Era Medicare Sdn. Bhd.. Cleared Oct 2022. https://www.510kdatabase.net/k222031/ 2022-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k222031-spinal-inner-fixation-system-fda-510k.jpg K222031 - Spinal Inner Fixation System K222031 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Changzhou Geasure Medical Apparatus and Instruments Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k222191/ 2022-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k222191-aixplorer-mach30-supersonic-mach30-fda-510k.jpg K222191 - Aixplorer MACH30 / SUPERSONIC MACH30, Aixplorer MACH20 / SUPERSONIC , MACH20, SUPERSONIC MACH40 K222191 is a FDA 510(k) cleared radiology medical device. Manufacturer: Supersonic Imagine. Cleared Oct 2022. https://www.510kdatabase.net/k222581/ 2022-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k222581-stela-automix-system-fda-510k.jpg K222581 - Stela Automix System K222581 is a FDA 510(k) cleared dental medical device. Manufacturer: Sdi Limited. Cleared Oct 2022. https://www.510kdatabase.net/k222583/ 2022-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k222583-stela-capsule-system-fda-510k.jpg K222583 - Stela Capsule System K222583 is a FDA 510(k) cleared dental medical device. Manufacturer: Sdi Limited. Cleared Oct 2022. https://www.510kdatabase.net/k222653/ 2022-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k222653-journey-ii-uk-and-engage-cementless-fda-510k.jpg K222653 - JOURNEY II UK™ and ENGAGE™ Cementless Partial Knee System K222653 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k223020/ 2022-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k223020-vs3-iridium-system-vs3-ir-fda-510k.jpg K223020 - VS3-Iridium System (VS3-IR) K223020 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Visionsense, Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k223064/ 2022-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k223064-ally-ii-uterine-positioning-system-ups-fda-510k.jpg K223064 - ALLY II Uterine Positioning System™ (UPS) K223064 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: CooperSurgical, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k223070/ 2022-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k223070-remi-robotic-navigation-system-fda-510k.jpg K223070 - Remi Robotic Navigation System K223070 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Fusion Robotics, LLC. Cleared Oct 2022. https://www.510kdatabase.net/k223079/ 2022-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k223079-stage-fda-510k.jpg K223079 - Stage K223079 is a FDA 510(k) cleared radiology medical device. Manufacturer: Spintech, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k223098/ 2022-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k223098-bakri-essential-postpartum-balloon-fda-510k.jpg K223098 - Bakri Essential Postpartum Balloon K223098 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Cook Incorporated. Cleared Oct 2022. https://www.510kdatabase.net/k212745/ 2022-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k212745-oracollectdx-fda-510k.jpg K212745 - ORAcollect®•Dx K212745 is a FDA 510(k) cleared chemistry medical device. Manufacturer: DNA Genotek, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k220332/ 2022-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k220332-umr-omega-with-uws-mr-mrs-fda-510k.jpg K220332 - uMR Omega with uWS-MR-MRS K220332 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k220880/ 2022-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k220880-arthrex-biosuture-fda-510k.jpg K220880 - Arthrex BioSuture K220880 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Arthrex, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k220949/ 2022-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k220949-architect-cmv-igg-fda-510k.jpg K220949 - Architect CMV IgG K220949 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Oct 2022. https://www.510kdatabase.net/k221322/ 2022-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k221322-custmbite-snoring-system-fda-510k.jpg K221322 - CUSTMBITE Snoring System K221322 is a FDA 510(k) cleared dental medical device. Manufacturer: Dental Choice Holdings, LLC. Cleared Oct 2022. https://www.510kdatabase.net/k221420/ 2022-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k221420-alphaid-at-home-genetic-health-risk-fda-510k.jpg K221420 - AlphaID™ At Home Genetic Health Risk Service K221420 is a FDA 510(k) cleared immunology medical device. Manufacturer: Progenika Biopharma S.A., A Grifols Company. Cleared Oct 2022. https://www.510kdatabase.net/k221489/ 2022-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k221489-artemis-proximal-femoral-nail-system-fda-510k.jpg K221489 - Artemis Proximal Femoral Nail System K221489 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Glw, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k222231/ 2022-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k222231-sin-dental-implant-system-fda-510k.jpg K222231 - S.I.N. Dental Implant System K222231 is a FDA 510(k) cleared dental medical device. Manufacturer: S.I.N. ? Sistema DE Implante Nacional S.A.. Cleared Oct 2022. https://www.510kdatabase.net/k222282/ 2022-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k222282-hemc-brand-locking-bone-plates-and-fda-510k.jpg K222282 - HEMC BRAND Locking Bone Plates and Screws Osteosynthesis Plating System K222282 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Hospital Equipment Manufacturing Company. Cleared Oct 2022. https://www.510kdatabase.net/k222288/ 2022-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k222288-dess-dental-smart-solutions-fda-510k.jpg K222288 - DESS Dental Smart Solutions K222288 is a FDA 510(k) cleared dental medical device. Manufacturer: Terrats Medical SL. Cleared Oct 2022. https://www.510kdatabase.net/k222348/ 2022-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k222348-jr-medic-fda-510k.jpg K222348 - JR MEDIC K222348 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jr Engineering & Medical Technologies (M) Sdn. Bhd.. Cleared Oct 2022. https://www.510kdatabase.net/k222505/ 2022-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k222505-curvafix-im-system-fda-510k.jpg K222505 - CurvaFix IM System K222505 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Curvafix, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k222514/ 2022-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k222514-sin-instrument-kits-fda-510k.jpg K222514 - S.I.N. Instrument Kits K222514 is a FDA 510(k) cleared general hospital medical device. Manufacturer: S.I.N. ? Sistema DE Implante Nacional S.A.. Cleared Oct 2022. https://www.510kdatabase.net/k222601/ 2022-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k222601-filmarray-pneumonia-panel-plus-fda-510k.jpg K222601 - FilmArray Pneumonia Panel plus K222601 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Biofire Diagnostics, LLC. Cleared Oct 2022. https://www.510kdatabase.net/k222678/ 2022-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k222678-mobility-enteral-feeding-system-fda-510k.jpg K222678 - Mobility+ Enteral Feeding System K222678 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Rockfield Medical. Cleared Oct 2022. https://www.510kdatabase.net/k222952/ 2022-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k222952-2008t-bluestar-hemodailysis-machine-fda-510k.jpg K222952 - 2008T BlueStar Hemodailysis Machine K222952 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC. Cleared Oct 2022. https://www.510kdatabase.net/k222966/ 2022-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k222966-cirq-arm-system-20-fda-510k.jpg K222966 - Cirq Arm System (2.0) K222966 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Brainlab AG. Cleared Oct 2022. https://www.510kdatabase.net/k213690/ 2022-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k213690-eclipse-blood-collection-set-fda-510k.jpg K213690 - Eclipse Blood Collection Set K213690 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Eclipse Medcorp, LLC. Cleared Oct 2022. https://www.510kdatabase.net/k220132/ 2022-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k220132-firefly-cervical-navigation-guide-fda-510k.jpg K220132 - FIREFLY® Cervical Navigation Guide K220132 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Mighty Oak Medical, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k220823/ 2022-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k220823-preat-abutments-fda-510k.jpg K220823 - Preat Abutments K220823 is a FDA 510(k) cleared dental medical device. Manufacturer: Preat Corporation. Cleared Oct 2022. https://www.510kdatabase.net/k221218/ 2022-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k221218-silverlon-wound-contact-burn-contact-fda-510k.jpg K221218 - Silverlon Wound Contact, Burn Contact Dressings K221218 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Argentum Medical, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k221374/ 2022-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k221374-disposable-medical-rubber-examination-fda-510k.jpg K221374 - Disposable Medical Rubber Examination Gloves (XS/S/M/L/XL) K221374 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hebei Titans Hongsen Medical Technology Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k221885/ 2022-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k221885-23andme-personal-genome-service-pgs-fda-510k.jpg K221885 - 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports K221885 is a FDA 510(k) cleared chemistry medical device. Manufacturer: 23AndMe, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k222032/ 2022-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k222032-neuromark-system-fda-510k.jpg K222032 - NEUROMARK System K222032 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Neurent Medical. Cleared Oct 2022. https://www.510kdatabase.net/k222047/ 2022-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k222047-leksell-gamma-knife-perfexion-leksell-fda-510k.jpg K222047 - Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant) K222047 is a FDA 510(k) cleared radiology medical device. Manufacturer: Elekta Solutions AB. Cleared Oct 2022. https://www.510kdatabase.net/k222269/ 2022-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k222269-dess-dental-smart-solutions-fda-510k.jpg K222269 - DESS Dental Smart Solutions K222269 is a FDA 510(k) cleared dental medical device. Manufacturer: Terrats Medical SL. Cleared Oct 2022. https://www.510kdatabase.net/k222281/ 2022-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k222281-intracept-intraosseous-nerve-ablation-fda-510k.jpg K222281 - Intracept Intraosseous Nerve Ablation System K222281 is a FDA 510(k) cleared neurology medical device. Manufacturer: Relievant Medsystems, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k222366/ 2022-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k222366-esocheck-cell-collection-device-fda-510k.jpg K222366 - EsoCheck Cell Collection Device K222366 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Lucid Diagnostics, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k222498/ 2022-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k222498-medical-examination-gloves-nitrile-xs-fda-510k.jpg K222498 - Medical Examination Gloves (Nitrile) (XS, S, M, L, XL) K222498 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Humanwell Healthcare Group Medical Supplies Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k222631/ 2022-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k222631-vassallo-gt-ext-fda-510k.jpg K222631 - VASSALLO GT EXT K222631 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Filmecc Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k222807/ 2022-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k222807-tema-elbow-system-line-extension-fda-510k.jpg K222807 - TEMA Elbow system - Line extension K222807 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Lima Corporate S.P.A.. Cleared Oct 2022. https://www.510kdatabase.net/k223058/ 2022-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k223058-ezray-air-2-wall-model-vex-s350w-fda-510k.jpg K223058 - EzRay Air 2 Wall (Model: VEX-S350W) K223058 is a FDA 510(k) cleared radiology medical device. Manufacturer: VATECH Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k223060/ 2022-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k223060-digix-fdx-fda-510k.jpg K223060 - DigiX FDX K223060 is a FDA 510(k) cleared radiology medical device. Manufacturer: Allengers Medical Systems Limited. Cleared Oct 2022. https://www.510kdatabase.net/k223065/ 2022-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k223065-adcura-sagittae-lateral-lumbar-fda-510k.jpg K223065 - Adcura® Sagittae® Lateral Lumbar Interbody Fusion Devices K223065 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Adcura, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k223235/ 2022-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k223235-nitrile-examination-gloves-powder-free-fda-510k.jpg K223235 - Nitrile Examination Gloves Powder Free (Tested for use with Chemotherapy Drugs) K223235 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Pt. Sintong Unigolden Glove. Cleared Oct 2022. https://www.510kdatabase.net/k212649/ 2022-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k212649-disposable-surgical-face-mask-fda-510k.jpg K212649 - Disposable Surgical Face Mask K212649 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Lyncmed Medical Technology (Beijing) Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k220565/ 2022-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k220565-hudson-rci-triflo-ii-incentive-deep-fda-510k.jpg K220565 - Hudson RCI Triflo II Incentive Deep Breathing Exerciser K220565 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Medline Industries, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k221169/ 2022-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k221169-jr-medic-nitrile-examination-gloves-fda-510k.jpg K221169 - JR MEDIC Nitrile Examination Gloves Powder Free- Black K221169 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jr Engineering & Medical Technologies (M) Sdn. Bhd.. Cleared Oct 2022. https://www.510kdatabase.net/k222070/ 2022-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k222070-endonaut-fda-510k.jpg K222070 - EndoNaut K222070 is a FDA 510(k) cleared radiology medical device. Manufacturer: Therenva Sas. Cleared Oct 2022. https://www.510kdatabase.net/k222303/ 2022-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k222303-unistik-pro-fda-510k.jpg K222303 - Unistik® Pro K222303 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Owen Mumford, Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k222365/ 2022-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k222365-leltek-ultrasound-imaging-system-model-fda-510k.jpg K222365 - Leltek Ultrasound Imaging System (Model: LU700 Series) K222365 is a FDA 510(k) cleared radiology medical device. Manufacturer: Leltek, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k222415/ 2022-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k222415-rexious-spinal-fixation-system-fda-510k.jpg K222415 - Rexious Spinal Fixation System K222415 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Dio Medical Corporation. Cleared Oct 2022. https://www.510kdatabase.net/k222470/ 2022-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k222470-3dicom-md-fda-510k.jpg K222470 - 3Dicom MD K222470 is a FDA 510(k) cleared radiology medical device. Manufacturer: Singular Health Pty, Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k222968/ 2022-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k222968-vantage-fortianorian-15t-mrt-1550-v80-fda-510k.jpg K222968 - Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR K222968 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Oct 2022. https://www.510kdatabase.net/k212493/ 2022-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k212493-kodex-epd-system-150-fda-510k.jpg K212493 - KODEX – EPD™ System 1.5.0 K212493 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Philips Medical Systems Nederland, B.V. (Pmsn). Cleared Oct 2022. https://www.510kdatabase.net/k220190/ 2022-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k220190-the-giro-growth-modulation-system-fda-510k.jpg K220190 - The GIRO Growth Modulation System K220190 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Pega Medical, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k221545/ 2022-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k221545-mectalif-anterior-extension-fda-510k.jpg K221545 - MectaLIF Anterior Extension K221545 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Oct 2022. https://www.510kdatabase.net/k221563/ 2022-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k221563-neurosteer-eeg-recorder-fda-510k.jpg K221563 - Neurosteer EEG Recorder K221563 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neurosteer, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k221783/ 2022-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k221783-safeticet-safety-lancet-fda-510k.jpg K221783 - SafetiCET Safety Lancet K221783 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Nsp Tech Pte, Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k222127/ 2022-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k222127-soft-palate-elevator-fda-510k.jpg K222127 - Soft Palate Elevator K222127 is a FDA 510(k) cleared dental medical device. Manufacturer: The Tmj Clinic PC. Cleared Oct 2022. https://www.510kdatabase.net/k213804/ 2022-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k213804-cobas-sars-cov-2-qualitative-for-use-fda-510k.jpg K213804 - cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems K213804 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Molecular Systems, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k222058/ 2022-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k222058-polyisoprene-surgical-glove-powder-fda-510k.jpg K222058 - Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant K222058 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wrp Asia Pacific Sdn. Bhd.. Cleared Oct 2022. https://www.510kdatabase.net/k210414/ 2022-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k210414-coveru-disposable-gown-with-tape-aami-fda-510k.jpg K210414 - CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown K210414 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medtecs (Taiwan) Corp.. Cleared Oct 2022. https://www.510kdatabase.net/k212391/ 2022-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k212391-mci-neuro-fixation-system-fda-510k.jpg K212391 - MCI-Neuro Fixation System K212391 is a FDA 510(k) cleared neurology medical device. Manufacturer: Mci Medical Concept Innovation, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k213128/ 2022-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k213128-intraop-vsp-software-device-fda-510k.jpg K213128 - IntraOp VSP Software Device K213128 is a FDA 510(k) cleared radiology medical device. Manufacturer: Xironetic, LLC. Cleared Oct 2022. https://www.510kdatabase.net/k220165/ 2022-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k220165-enteral-transition-adaptor-fda-510k.jpg K220165 - Enteral Transition Adaptor K220165 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: GBUK Group, Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k220273/ 2022-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k220273-onetouch-non-paraben-lubricant-gel-fda-510k.jpg K220273 - Onetouch Non-paraben Lubricant Gel K220273 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Thai Nippon Rubber Industry Public Company Limited.. Cleared Oct 2022. https://www.510kdatabase.net/k221022/ 2022-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k221022-nextdent-ortho-flex-fda-510k.jpg K221022 - NextDent Ortho Flex K221022 is a FDA 510(k) cleared dental medical device. Manufacturer: Vertex-Dental B.V.. Cleared Oct 2022. https://www.510kdatabase.net/k221443/ 2022-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k221443-purelift-pro-plus-fda-510k.jpg K221443 - PureLift Pro Plus K221443 is a FDA 510(k) cleared neurology medical device. Manufacturer: Xtreem Pulse, LLC. Cleared Oct 2022. https://www.510kdatabase.net/k221462/ 2022-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k221462-depuy-reclaim-monobloc-revision-fda-510k.jpg K221462 - DePuy Reclaim Monobloc Revision Femoral Stem K221462 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Ireland UC. Cleared Oct 2022. https://www.510kdatabase.net/k221643/ 2022-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k221643-hair-removal-device-model-ipl-d26-ipl-fda-510k.jpg K221643 - Hair Removal Device (Model: IPL-D26, IPL-D19) K221643 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Desida Technology Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k221751/ 2022-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k221751-nuvasive-cohere-alif-system-fda-510k.jpg K221751 - NuVasive Cohere ALIF System Intervertebral Body Fusion Device K221751 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Oct 2022. https://www.510kdatabase.net/k221958/ 2022-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k221958-flex-mi-fda-510k.jpg K221958 - Flex-MI K221958 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Emsi, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k221992/ 2022-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k221992-electronic-pulse-stimulator-fda-510k.jpg K221992 - Electronic Pulse Stimulator K221992 is a FDA 510(k) cleared neurology medical device. Manufacturer: Beijing Choice Electronic Technology Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k222141/ 2022-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k222141-safety-blood-collection-needle-without-fda-510k.jpg K222141 - Safety Blood Collection Needle (Without Needle Holder) K222141 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k222199/ 2022-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k222199-collagen-pin-percutaneous-induction-fda-510k.jpg K222199 - Collagen P.I.N. (Percutaneous Induction Needling) K222199 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Induction Therapies, LLC. Cleared Oct 2022. https://www.510kdatabase.net/k222201/ 2022-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k222201-biological-feedback-and-stimulation-fda-510k.jpg K222201 - Biological Feedback and Stimulation System K222201 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Medlander Medical Technology, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k222215/ 2022-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k222215-ipd-dental-implant-abutments-fda-510k.jpg K222215 - IPD Dental Implant Abutments K222215 is a FDA 510(k) cleared dental medical device. Manufacturer: Implant Protesis Dental 2004, S.L.. Cleared Oct 2022. https://www.510kdatabase.net/k222270/ 2022-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k222270-hedron-cervical-spacers-hedron-lumbar-fda-510k.jpg K222270 - HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS Instruments K222270 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k222349/ 2022-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k222349-jr-medic-nitrile-examination-gloves-fda-510k.jpg K222349 - JR MEDIC Nitrile Examination Gloves Powder Free (Orange, Purple) K222349 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jr Engineering & Medical Technologies (M) Sdn. Bhd.. Cleared Oct 2022. https://www.510kdatabase.net/k222632/ 2022-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k222632-uhr-bipolar-implants-restoration-gap-fda-510k.jpg K222632 - UHR Bipolar Implants, Restoration GAP II Implants K222632 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp., Dba Stryker Orthopaedics. Cleared Oct 2022. https://www.510kdatabase.net/k223042/ 2022-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k223042-viz-lvo-contact-fda-510k.jpg K223042 - Viz LVO ContaCT K223042 is a FDA 510(k) cleared radiology medical device. Manufacturer: Viz. Ai, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k213106/ 2022-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k213106-bti-interna-dental-implant-system-fda-510k.jpg K213106 - BTI Interna Dental Implant System UnicCa - Prosthetic Components K213106 is a FDA 510(k) cleared dental medical device. Manufacturer: B.T.I. Biotechnology Institute, Sl.. Cleared Oct 2022. https://www.510kdatabase.net/k213429/ 2022-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k213429-accusert-needle-inserter-fda-510k.jpg K213429 - AccuSert Needle Inserter K213429 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Emed Technologies Corporation. Cleared Oct 2022. https://www.510kdatabase.net/k213466/ 2022-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k213466-houdini-cross-support-catheter-fda-510k.jpg K213466 - Houdini Cross Support Catheter K213466 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cruzar Medsystems, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k214073/ 2022-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k214073-ewave-monitor-fda-510k.jpg K214073 - eWave Monitor K214073 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Wearlinq, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k220099/ 2022-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k220099-eclinic-stethopod-fda-510k.jpg K220099 - eClinic Stethopod K220099 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Homediagnostic, LLC. Cleared Oct 2022. https://www.510kdatabase.net/k220527/ 2022-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k220527-padnet-xpress-fda-510k.jpg K220527 - PADnet Xpress K220527 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Collaborative Care Diagnostics, LLC, D.B.A. Biomedix. Cleared Oct 2022. https://www.510kdatabase.net/k220870/ 2022-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k220870-biofire-global-fever-panel-biofire-fda-510k.jpg K220870 - BioFire Global Fever Panel, BIOFIRE SHIELD Control Kit for the BioFire Global Fever Panel K220870 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Biofire Defense, LLC. Cleared Oct 2022. https://www.510kdatabase.net/k221740/ 2022-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k221740-smith-nephew-intellio-4k-camera-fda-510k.jpg K221740 - SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NETWORK ENABLED (72205447), SMITH & NEPHEW INTELLIO 4K CAMERA CONTROL UNIT, NON-NETWORK ENABLED (72205448) K221740 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith and Nephew, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k221947/ 2022-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k221947-tyber-medical-staple-fixation-system-fda-510k.jpg K221947 - Tyber Medical Staple Fixation System (various) K221947 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tyber Medical, LLC. Cleared Oct 2022. https://www.510kdatabase.net/k221977/ 2022-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k221977-disposable-surgical-gown-g4003-fda-510k.jpg K221977 - Disposable Surgical Gown (G4003) K221977 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Xiantao Topmed Nonwoven Protective Products Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k222361/ 2022-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k222361-ai-rad-companion-musculoskeletal-fda-510k.jpg K222361 - AI-Rad Companion (Musculoskeletal) K222361 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k222404/ 2022-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k222404-evo-seeg-system-fda-510k.jpg K222404 - Evo® sEEG System K222404 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neuroone Medical Technologies Corp.. Cleared Oct 2022. https://www.510kdatabase.net/k222547/ 2022-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k222547-electric-nasal-aspirator-fda-510k.jpg K222547 - Electric nasal aspirator K222547 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Shenzhen Xinlianfeng Technology Co.,Ltd. Cleared Oct 2022. https://www.510kdatabase.net/k222827/ 2022-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k222827-da-vinci-firefly-imaging-system-fda-510k.jpg K222827 - da Vinci Firefly Imaging System K222827 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k222842/ 2022-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k222842-v-patch-cardiac-monitor-fda-510k.jpg K222842 - V-Patch Cardiac Monitor K222842 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shandong Corecare Technology Limited. Cleared Oct 2022. https://www.510kdatabase.net/k222886/ 2022-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k222886-mercu-1717v-fda-510k.jpg K222886 - Mercu 1717V K222886 is a FDA 510(k) cleared radiology medical device. Manufacturer: Iray Technology Taicang , Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k211409/ 2022-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k211409-proximerge-2-dental-implant-system-fda-510k.jpg K211409 - Proximerge 2 Dental Implant System K211409 is a FDA 510(k) cleared dental medical device. Manufacturer: Quadric Biomed, LLC. Cleared Oct 2022. https://www.510kdatabase.net/k213742/ 2022-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k213742-infinity-pro-logic-quality-sprint-fda-510k.jpg K213742 - Infinity Pro, Logic, Quality, Sprint K213742 is a FDA 510(k) cleared dental medical device. Manufacturer: Olsen Ind?stria E Com?rcio S.A.. Cleared Oct 2022. https://www.510kdatabase.net/k220992/ 2022-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k220992-disposable-powder-free-vinyl-exam-fda-510k.jpg K220992 - Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple K220992 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ever Global (Vietnam) Enterprise Corporation. Cleared Oct 2022. https://www.510kdatabase.net/k221029/ 2022-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k221029-peri-guard-repair-patch-supple-peri-fda-510k.jpg K221029 - PERI-GUARD Repair Patch, SUPPLE PERI-GUARD Repair Patch K221029 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Synovis Life Technologies, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k221032/ 2022-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k221032-vascu-guard-vascular-repair-patch-fda-510k.jpg K221032 - Vascu-Guard Vascular Repair Patch K221032 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Synovis Life Technologies, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k221728/ 2022-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k221728-aviator-anterior-cervical-plating-acp-fda-510k.jpg K221728 - Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran™ Anterior Cervical Plating (ACP) System, Reflex™ Hybrid ACP System, UniVise™ Spinous Process Fixation Plate K221728 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Corporation. Cleared Oct 2022. https://www.510kdatabase.net/k221795/ 2022-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k221795-stern-fix-sternal-stabilization-system-fda-510k.jpg K221795 - STERN FIX Sternal Stabilization System K221795 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Neos Surgery S.L. Cleared Oct 2022. https://www.510kdatabase.net/k222643/ 2022-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k222643-sirius-pintuition-seed-sirius-fda-510k.jpg K222643 - Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit K222643 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sirius Medical Systems B.V.. Cleared Oct 2022. https://www.510kdatabase.net/k222856/ 2022-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k222856-somavac-100-sustained-vacuum-system-fda-510k.jpg K222856 - SOMAVAC 100 Sustained Vacuum System K222856 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Somavac Medical Solutions, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k222890/ 2022-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k222890-radiance-ultra-32-4k-zerowire-duo-fda-510k.jpg K222890 - RADIANCE ULTRA 32 4K ZEROWIRE DUO K222890 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Nds Surgical Imaging, LLC. Cleared Oct 2022. https://www.510kdatabase.net/k203549/ 2022-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k203549-nova-primary-glucose-analyzer-system-fda-510k.jpg K203549 - Nova Primary Glucose Analyzer System K203549 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Nova Biomedical Corporation. Cleared Oct 2022. https://www.510kdatabase.net/k213123/ 2022-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k213123-evos-wrist-spanning-plate-fda-510k.jpg K213123 - EVOS Wrist Spanning Plate K213123 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k213978/ 2022-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k213978-teligen-system-fda-510k.jpg K213978 - TELIGEN System K213978 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International SARL. Cleared Oct 2022. https://www.510kdatabase.net/k221072/ 2022-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k221072-truedraw-lancing-device-mini-lancing-fda-510k.jpg K221072 - TRUEdraw Lancing Device, Mini Lancing Device K221072 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Trividia Health. Cleared Oct 2022. https://www.510kdatabase.net/k221321/ 2022-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k221321-mac-5-a4-mac-5-a5-mac-5-lite-resting-fda-510k.jpg K221321 - MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System K221321 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k221632/ 2022-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k221632-spine-camp-fda-510k.jpg K221632 - Spine CAMP™ K221632 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medical Metrics, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k221986/ 2022-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k221986-xo-score-lp-percutaneous-transluminal-fda-510k.jpg K221986 - XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter K221986 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Transit Scientific, LLC. Cleared Oct 2022. https://www.510kdatabase.net/k222167/ 2022-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k222167-e-z-chek-chlorine-residual-test-strips-fda-510k.jpg K222167 - E-Z Chek Chlorine Residual Test Strips (K100-0101B) K222167 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Reprocessing Products Corporation (Rpc). Cleared Oct 2022. https://www.510kdatabase.net/k222203/ 2022-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k222203-dualxslimr-tplif-fda-510k.jpg K222203 - DualXSLIM(R) T/PLIF K222203 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Amplify Surgical, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k222298/ 2022-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k222298-violet-nitrile-powder-free-patient-fda-510k.jpg K222298 - Violet Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid K222298 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Onetexx Sdn Bhd. Cleared Oct 2022. https://www.510kdatabase.net/k222572/ 2022-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k222572-fortis-and-hana-anterior-cervical-fda-510k.jpg K222572 - FORTIS and HANA Anterior Cervical Plate System, Rex Anterior Cervical Plate System, and BALTEUM™ & BALTEUM-ONE™ Lumbar Plate System K222572 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Dio Medical Corporation. Cleared Oct 2022. https://www.510kdatabase.net/k222657/ 2022-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k222657-mebo-wound-dressing-fda-510k.jpg K222657 - MEBO Wound Dressing K222657 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Mebo Life Science, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k222721/ 2022-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k222721-violet-nitrile-powder-free-patient-fda-510k.jpg K222721 - Violet Nitrile Powder Free Patient Examination Glove, Non Sterile K222721 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Safeskin Retailing (Hk) Limited. Cleared Oct 2022. https://www.510kdatabase.net/den220024/ 2022-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/den220024-scannav-anatomy-peripheral-nerve-block-fda-510k.jpg DEN220024 - ScanNav Anatomy Peripheral Nerve Block DEN220024 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Intelligent Ultrasound Limited. Cleared Oct 2022. https://www.510kdatabase.net/k211785/ 2022-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k211785-cassatt-sij-fixation-system-fda-510k.jpg K211785 - CASSATT™ SIJ Fixation System K211785 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ctl Medical Corporation. Cleared Oct 2022. https://www.510kdatabase.net/k212746/ 2022-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k212746-attune-revision-cones-fda-510k.jpg K212746 - ATTUNE Revision Cones K212746 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Ireland UC. Cleared Oct 2022. https://www.510kdatabase.net/k221014/ 2022-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k221014-effortless-oxygen-conserver-system-fda-510k.jpg K221014 - Effortless Oxygen Conserver System Models Effortless Pro and Effortless Mobile K221014 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Effortless Oxygen, LLC. Cleared Oct 2022. https://www.510kdatabase.net/k221175/ 2022-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k221175-multi-lancet-device-2-relion-premier-fda-510k.jpg K221175 - Multi-Lancet Device 2, ReliOn Premier Lancing Device K221175 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Arkray, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k221308/ 2022-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k221308-disposable-syringe-with-permanently-fda-510k.jpg K221308 - Disposable Syringe with permanently attached needle, Safety Syringe with permanently attached needle K221308 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangxi Maidikang Medical Devices Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k221372/ 2022-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k221372-yuwell-electronic-blood-pressure-monitor-fda-510k.jpg K221372 - YUWELL Electronic Blood Pressure Monitor K221372 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Jiangsu Yuyue Medical Equipment& Supply Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k221936/ 2022-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k221936-standalone-alif-interbody-fusion-system-fda-510k.jpg K221936 - Standalone ALIF Interbody Fusion System K221936 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Eminent Spine. Cleared Oct 2022. https://www.510kdatabase.net/k222074/ 2022-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k222074-powder-free-nitrile-examination-gloves-fda-510k.jpg K222074 - Powder Free Nitrile Examination Gloves (Blue, Black, White and/or Violet Blue), Powder Free Latex Examination Gloves K222074 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zibo Langu New Material Technology Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k222209/ 2022-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k222209-acqmap-high-resolution-imaging-and-fda-510k.jpg K222209 - AcQMap High Resolution Imaging and Mapping System K222209 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Acutus Medical, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k222495/ 2022-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k222495-mobility-scooter-model-w3331f-fda-510k.jpg K222495 - Mobility Scooter, Model: W3331F K222495 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zhejiang Innuovo Rehabilitation Devices Co.,Ltd. Cleared Oct 2022. https://www.510kdatabase.net/k222566/ 2022-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k222566-zimmer-persona-personalized-knee-system-fda-510k.jpg K222566 - Zimmer Persona Personalized Knee System K222566 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k222793/ 2022-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k222793-wavelinq-generator-fda-510k.jpg K222793 - WavelinQ™ Generator K222793 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k222855/ 2022-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k222855-digital-radiography-cxdi-pro-digital-fda-510k.jpg K222855 - Digital Radiography CXDI-Pro, Digital Radiography D1 K222855 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k213049/ 2022-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k213049-stimpod-nms450-nerve-stimulator-fda-510k.jpg K213049 - STIMPOD NMS450 Nerve Stimulator K213049 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Xavant Technology (Pty), Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k221574/ 2022-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k221574-ludwig-electrosurgical-device-fda-510k.jpg K221574 - LUDWIG Electrosurgical Device K221574 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesthetics Biomedical. Cleared Oct 2022. https://www.510kdatabase.net/k221979/ 2022-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k221979-pulse-oximeter-model-c101a2-c101b1-fda-510k.jpg K221979 - Pulse Oximeter (Model C101A2, C101B1, C101A3) K221979 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Imdk Medical Technology Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k222791/ 2022-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k222791-safebreak-vascular-fda-510k.jpg K222791 - SafeBreak Vascular K222791 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Lineus Medical, LLC. Cleared Oct 2022. https://www.510kdatabase.net/k222276/ 2022-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k222276-conduit-cages-fda-510k.jpg K222276 - CONDUIT Cages K222276 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Spine. Cleared Oct 2022. https://www.510kdatabase.net/k213183/ 2022-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k213183-safety-insulin-pen-needles-fda-510k.jpg K213183 - Safety Insulin Pen Needles K213183 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zhejiang Kindly Medical Devices Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k213748/ 2022-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k213748-corelevee-fda-510k.jpg K213748 - CoreLevee K213748 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Lutronic Corporation. Cleared Oct 2022. https://www.510kdatabase.net/k213857/ 2022-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k213857-heartflow-analysis-fda-510k.jpg K213857 - HeartFlow Analysis K213857 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: HeartFlow, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k214054/ 2022-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k214054-tp-orthodontics-light-cure-adhesive-fda-510k.jpg K214054 - TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520 K214054 is a FDA 510(k) cleared dental medical device. Manufacturer: Tp Orthodontics, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k220318/ 2022-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k220318-pal-infiltration-system-fda-510k.jpg K220318 - PAL Infiltration System K220318 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Microaire Surgical Instruments, LLC. Cleared Oct 2022. https://www.510kdatabase.net/k220914/ 2022-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k220914-tornier-perform-humeral-system-fracture-fda-510k.jpg K220914 - Tornier Perform Humeral System – Fracture K220914 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tornier, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k220994/ 2022-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k220994-shoulder-pacemakertm-fda-510k.jpg K220994 - Shoulder PacemakerTM K220994 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Ncs Lab Srl. Cleared Oct 2022. https://www.510kdatabase.net/k221093/ 2022-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k221093-x-cube-70-x-cube-90-fda-510k.jpg K221093 - X-CUBE 70, X-CUBE 90 K221093 is a FDA 510(k) cleared radiology medical device. Manufacturer: Alpinion Medical Systems Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k221172/ 2022-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k221172-focus-interbody-system-fda-510k.jpg K221172 - FOCUS Interbody System K221172 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Oc Medical Devices. Cleared Oct 2022. https://www.510kdatabase.net/k221305/ 2022-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k221305-ai-rad-companion-organs-rt-fda-510k.jpg K221305 - AI-Rad Companion Organs RT K221305 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k221447/ 2022-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k221447-southern-anterior-screw-fixated-cage-fda-510k.jpg K221447 - Southern Anterior Screw Fixated Cage (SASCA) K221447 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Southern Medical (Pty) , Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k221501/ 2022-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k221501-syngovia-viewgo-fda-510k.jpg K221501 - syngo.via View&GO K221501 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Healthcare GmbH. Cleared Oct 2022. https://www.510kdatabase.net/k221504/ 2022-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k221504-bd-surgiphor-antimicrobial-irrigation-fda-510k.jpg K221504 - BD Surgiphor™ Antimicrobial Irrigation System K221504 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bd. Cleared Oct 2022. https://www.510kdatabase.net/k221840/ 2022-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k221840-hakim-programmable-valves-hakim-fda-510k.jpg K221840 - Hakim Programmable Valves, Hakim Precision Fixed Pressure Valves K221840 is a FDA 510(k) cleared neurology medical device. Manufacturer: Integra Lifesciences Production Corporation. Cleared Oct 2022. https://www.510kdatabase.net/k221858/ 2022-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k221858-zsfab-lumbar-interbody-system-fda-510k.jpg K221858 - ZSFab Lumbar Interbody System K221858 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zsfab, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k221886/ 2022-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k221886-sublime-microcatheter-fda-510k.jpg K221886 - Sublime Microcatheter K221886 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Surmodics,Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k222284/ 2022-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k222284-voyant-maryland-fusion-device-with-fda-510k.jpg K222284 - Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214) K222284 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Applied Medical Resources Corporation. Cleared Oct 2022. https://www.510kdatabase.net/k222407/ 2022-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k222407-16ch-breast-coil-16ch-breast-coils-15t-fda-510k.jpg K222407 - 16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil, 3T 16ch Breast Coil K222407 is a FDA 510(k) cleared radiology medical device. Manufacturer: Neocoil, LLC. Cleared Oct 2022. https://www.510kdatabase.net/k222537/ 2022-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k222537-ipl-hair-removal-device-models-fda-510k.jpg K222537 - IPL Hair Removal Device, Model(s): skn001,skn005,skn006,skn002,RoseSkinCo Lumi K222537 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Ishine Technology Company Limited. Cleared Oct 2022. https://www.510kdatabase.net/k222662/ 2022-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k222662-vitrea-ct-cardiac-analysis-fda-510k.jpg K222662 - Vitrea CT Cardiac Analysis K222662 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Informatics, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k222797/ 2022-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k222797-x-pac-expandable-lumbar-cage-system-fda-510k.jpg K222797 - X-Pac Expandable Lumbar Cage System K222797 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Expanding Innovations, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/den210027/ 2022-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/den210027-the-cooral-system-fda-510k.jpg DEN210027 - The Cooral System DEN210027 is a FDA 510(k) cleared dental medical device. Manufacturer: Braincool AB. Cleared Oct 2022. https://www.510kdatabase.net/k211321/ 2022-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k211321-wireless-probe-type-ultrasound-scanner-fda-510k.jpg K211321 - Wireless Probe Type Ultrasound Scanner (Model: CProbe K211321 is a FDA 510(k) cleared radiology medical device. Manufacturer: Guangzhou Sonostar Technologies Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k211427/ 2022-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k211427-creokorrekt-aligners-fda-510k.jpg K211427 - CREOKORREKT Aligners K211427 is a FDA 510(k) cleared dental medical device. Manufacturer: Creodent Prosthetics, Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k212702/ 2022-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k212702-imst-fixture-system-fda-510k.jpg K212702 - IM/ST Fixture System K212702 is a FDA 510(k) cleared dental medical device. Manufacturer: Guilin Fiteeth Medical Instrument Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k213396/ 2022-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k213396-spife-a1at-kit-fda-510k.jpg K213396 - SPIFE A1AT kit K213396 is a FDA 510(k) cleared immunology medical device. Manufacturer: Helena Laboratories, Corp.. Cleared Oct 2022. https://www.510kdatabase.net/k220730/ 2022-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k220730-allflex-ureteral-catheters-krait-fda-510k.jpg K220730 - allFlex Ureteral Catheters, Krait Ureteral Catheters K220730 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Allwin Medical Devices, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k220805/ 2022-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k220805-vitek-2-ast-gram-positive-cefoxitin-fda-510k.jpg K220805 - VITEK 2 AST-Gram Positive Cefoxitin Screen K220805 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k220853/ 2022-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k220853-picoway-laser-system-fda-510k.jpg K220853 - PicoWay Laser System K220853 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Candela Corporation. Cleared Oct 2022. https://www.510kdatabase.net/k220857/ 2022-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k220857-x-cube-50-x-cube-60-fda-510k.jpg K220857 - X-CUBE 50, X-CUBE 60 K220857 is a FDA 510(k) cleared radiology medical device. Manufacturer: Alpinion Medical Systems Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k221770/ 2022-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k221770-fiber-laser-treatment-system-fda-510k.jpg K221770 - Fiber Laser Treatment System K221770 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shanghai Apolo Medical Technology Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k221857/ 2022-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k221857-aneroid-sphygmomanometer-with-fda-510k.jpg K221857 - Aneroid sphygmomanometer with stethoscope, QL-50, Aneroid sphygmomanometer, QL-20, Aneroid sphygmomanometer, QL-201 K221857 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Zhejiang Lude Technology Development Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k221989/ 2022-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k221989-the-oligio-fda-510k.jpg K221989 - The Oligio K221989 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wontech Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k222081/ 2022-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k222081-id-510-irestore-elite-fda-510k.jpg K222081 - ID-510 iRestore Elite K222081 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Freedom Laser Therapy, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k222087/ 2022-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k222087-scig60-infusion-system-fda-510k.jpg K222087 - SCIg60 Infusion System K222087 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Emed Technologies Corporation. Cleared Oct 2022. https://www.510kdatabase.net/k222113/ 2022-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k222113-abiomed-14fr-low-profile-introducer-set-fda-510k.jpg K222113 - Abiomed 14Fr Low Profile Introducer Set K222113 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abiomed, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k222448/ 2022-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k222448-unity-sacroiliac-joint-fixation-system-fda-510k.jpg K222448 - UNITY Sacroiliac Joint Fixation System K222448 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Dio Medical Corporation. Cleared Oct 2022. https://www.510kdatabase.net/k222473/ 2022-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k222473-expedium-spine-system-expedium-verse-fda-510k.jpg K222473 - EXPEDIUM® Spine System, EXPEDIUM VERSE® Spine System: ALTALYNE™ Ultra Rods K222473 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International SARL. Cleared Oct 2022. https://www.510kdatabase.net/k222763/ 2022-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k222763-responsive-arthroscopy-mustang-and-fda-510k.jpg K222763 - Responsive Arthroscopy Mustang and Mustang Knotless Suture Anchors K222763 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Responsive Arthroscopy, LLC. Cleared Oct 2022. https://www.510kdatabase.net/k203638/ 2022-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k203638-at-patch-ecg-analysis-system-fda-510k.jpg K203638 - AT-Patch ECG Analysis System K203638 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Atsens Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k211872/ 2022-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k211872-piezoimplant-system-fda-510k.jpg K211872 - PiezoImplant System K211872 is a FDA 510(k) cleared dental medical device. Manufacturer: Rex Implants, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k213120/ 2022-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k213120-ow100s-model-ow100s-us-fda-510k.jpg K213120 - OW100S (model OW100S-US) K213120 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Tissue Regeneration Technologies, LLC Dba AS Softwave Trt. Cleared Oct 2022. https://www.510kdatabase.net/k220102/ 2022-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k220102-most-t-autoclave-fda-510k.jpg K220102 - MOST-T Autoclave K220102 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shinva Medical Instrument Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k220227/ 2022-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k220227-auto-folding-scooter-s21f-fda-510k.jpg K220227 - Auto Folding Scooter, S21F K220227 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Heartway Medical Products Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k220911/ 2022-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k220911-elecsys-cmv-igg-fda-510k.jpg K220911 - Elecsys CMV IgG K220911 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Diagnostics. Cleared Oct 2022. https://www.510kdatabase.net/k220923/ 2022-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k220923-elecsys-hsv-1-igg-08948844160-fda-510k.jpg K220923 - Elecsys HSV-1 IgG (08948844160) K220923 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Diagnostics. Cleared Oct 2022. https://www.510kdatabase.net/k220924/ 2022-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k220924-elecsys-hsv-2-igg-08948887160-fda-510k.jpg K220924 - Elecsys HSV-2 IgG (08948887160) K220924 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Diagnostics. Cleared Oct 2022. https://www.510kdatabase.net/k221263/ 2022-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k221263-aqua-naina-plus-sterile-saline-solution-fda-510k.jpg K221263 - Aqua Naina Plus Sterile Saline Solution K221263 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Chemtex USA, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k221510/ 2022-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k221510-trusfil-flow-flowable-composite-fda-510k.jpg K221510 - TrusFIL-Flow Flowable Composite Restorative K221510 is a FDA 510(k) cleared dental medical device. Manufacturer: Rizhao Huge Biomaterials Company, Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k221576/ 2022-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k221576-ameda-pearl-electric-breast-pump-fda-510k.jpg K221576 - Ameda Pearl Electric Breast Pump K221576 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ameda, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k221712/ 2022-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k221712-fotona-xpulse-laser-system-family-fda-510k.jpg K221712 - Fotona XPulse Laser System Family (XPulse 1064 nm, XPulse 810 nm, XPulse 980 nm) K221712 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Fotona D.O.O.. Cleared Oct 2022. https://www.510kdatabase.net/k221913/ 2022-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k221913-arm-blood-pressure-monitor-fda-510k.jpg K221913 - Arm Blood Pressure Monitor K221913 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Alicn Medical (Shenzhen), Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k222064/ 2022-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k222064-the-alma-soprano-titanium-fda-510k.jpg K222064 - The Alma Soprano Titanium K222064 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Alma Lasers, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k222068/ 2022-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k222068-durex-penck-iii-regular-fda-510k.jpg K222068 - Durex Penck III Regular K222068 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Rb Health (Us), LLC. Cleared Oct 2022. https://www.510kdatabase.net/k214116/ 2022-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k214116-aami4-isolation-gown-fda-510k.jpg K214116 - AAMI4 Isolation Gown K214116 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hubei Xinxin Non-Woven Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k220169/ 2022-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k220169-sonome-wireless-probe-type-ultrasound-fda-510k.jpg K220169 - SonoMe Wireless Probe Type Ultrasound Scanner (Model: 5C, 5CB, H5C, 10L, 14L, 10LB, H10L, H5C10L) and SonoFinder Wireless Probe Type Ultrasound Scanner (Model: SF14L25) K220169 is a FDA 510(k) cleared radiology medical device. Manufacturer: Bionet Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k221830/ 2022-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k221830-apyx-one-console-fda-510k.jpg K221830 - Apyx One Console K221830 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Apyx Medical Corporation. Cleared Oct 2022. https://www.510kdatabase.net/k221951/ 2022-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k221951-branchor-balloon-guide-catheter-fda-510k.jpg K221951 - Branchor Balloon Guide Catheter K221951 is a FDA 510(k) cleared neurology medical device. Manufacturer: Asahi Intecc Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k222079/ 2022-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k222079-connected-or-hub-with-device-and-voice-fda-510k.jpg K222079 - Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control K222079 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker Endoscopy. Cleared Oct 2022. https://www.510kdatabase.net/k222157/ 2022-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k222157-echo-photocoagulator-fda-510k.jpg K222157 - ECHO Photocoagulator K222157 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Norlase. Cleared Oct 2022. https://www.510kdatabase.net/k222335/ 2022-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k222335-surgical-mask-fda-510k.jpg K222335 - Surgical Mask K222335 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Luoyang Sunmed Devices Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k222432/ 2022-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k222432-ipl-hair-removal-device-models-kca423-fda-510k.jpg K222432 - IPL Hair Removal Device, Model(s): KCA423, KCA437, KCA439 K222432 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Hunan Guangye Biotechnology Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k222435/ 2022-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k222435-renamel-microhybrid-fda-510k.jpg K222435 - Renamel® Microhybrid K222435 is a FDA 510(k) cleared dental medical device. Manufacturer: Cosmedent, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k222744/ 2022-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k222744-sol-m-luer-lock-syringe-fda-510k.jpg K222744 - Sol-M Luer Lock Syringe K222744 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sol-Millennium Medical, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k223008/ 2022-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k223008-disposable-vinyl-examination-gloves-fda-510k.jpg K223008 - Disposable Vinyl Examination Gloves K223008 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangxi Handspro Products Solutions Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k202163/ 2022-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k202163-mico-one-orthodontic-screw-fda-510k.jpg K202163 - Mico One Orthodontic Screw K202163 is a FDA 510(k) cleared dental medical device. Manufacturer: Ze Fang Technology Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k213061/ 2022-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k213061-supercheck-pro-blood-glucose-fda-510k.jpg K213061 - SuperCheck Pro Blood Glucose Monitoring System K213061 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Ok Biotech Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k213610/ 2022-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k213610-kogent-disposable-copper-forceps-fda-510k.jpg K213610 - Kogent Disposable Copper Forceps, Kogent Disposable Irrigating Copper Forceps, Kogent Disposable Illuminating Copper Forceps K213610 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Katalyst Surgical, LLC. Cleared Oct 2022. https://www.510kdatabase.net/k213969/ 2022-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k213969-visionair-patient-specific-airway-stent-fda-510k.jpg K213969 - VisionAir Patient-Specific Airway Stent K213969 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: New Cos Inc. Dba Visionair Solutions. Cleared Oct 2022. https://www.510kdatabase.net/k220057/ 2022-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k220057-disposable-sterile-syringe-with-fda-510k.jpg K220057 - Disposable Sterile Syringe with permanently attached needle K220057 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shinva Ande Healthcare Apparatus Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k220092/ 2022-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k220092-yadu-surgical-gowns-fda-510k.jpg K220092 - YADU Surgical Gowns K220092 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Henan Yadu Industrial Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k220111/ 2022-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k220111-respirasense-fda-510k.jpg K220111 - RespiraSense K220111 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Pmd Solutions. Cleared Oct 2022. https://www.510kdatabase.net/k220156/ 2022-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k220156-electrically-powered-wheelchair-joy-fda-510k.jpg K220156 - Electrically Powered Wheelchair, Joy Rider K220156 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Tung Keng Enterprise Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k220256/ 2022-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k220256-mim-ablation-fda-510k.jpg K220256 - MIM-Ablation K220256 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mim Software, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k220267/ 2022-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k220267-amsafe-neuflo-needleless-connector-fda-510k.jpg K220267 - AMSafe NeuFlo Needleless Connector K220267 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Amsino International, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k220709/ 2022-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k220709-briefcase-fda-510k.jpg K220709 - BriefCase K220709 is a FDA 510(k) cleared radiology medical device. Manufacturer: Aidoc Medical , Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k221154/ 2022-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k221154-infant-heel-warmertm-fda-510k.jpg K221154 - Infant Heel WarmerTM K221154 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: International Biomedical. Cleared Oct 2022. https://www.510kdatabase.net/k221170/ 2022-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k221170-forehead-thermometer-models-aoj-f101-fda-510k.jpg K221170 - Forehead Thermometer, models AOJ-F101, AOJ-F102, AOJ-F103, AOJ-F104 AOJ-F105, AOJ-F106, AOJ-F107 K221170 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen AOJ Medical Technology Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k221310/ 2022-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k221310-endoscopic-clean-connecting-tubes-fda-510k.jpg K221310 - Endoscopic Clean Connecting Tubes, Endoscopic CO2 Source Tubing K221310 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Changzhou Endoclean Medical Device Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k221492/ 2022-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k221492-steritite-container-system-with-fda-510k.jpg K221492 - SteriTite Container System with MediTray Parts K221492 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Case Medical, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k221498/ 2022-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k221498-miha-bodytec-ii-fda-510k.jpg K221498 - Miha Bodytec II K221498 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Miha Bodytec GmbH. Cleared Oct 2022. https://www.510kdatabase.net/k221575/ 2022-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k221575-pre-formed-blue-fda-510k.jpg K221575 - Pre-Formed Blue K221575 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Lake Region Medical. Cleared Oct 2022. https://www.510kdatabase.net/k221764/ 2022-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k221764-inbody-blood-pressure-monitor-model-fda-510k.jpg K221764 - InBody Blood pressure monitor, Model BPBIO480KV K221764 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inbody Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k221818/ 2022-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k221818-rebellion-fda-510k.jpg K221818 - Rebellion K221818 is a FDA 510(k) cleared neurology medical device. Manufacturer: Morpheus AG. Cleared Oct 2022. https://www.510kdatabase.net/k222028/ 2022-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k222028-identiti-porous-ti-interbody-system-fda-510k.jpg K222028 - IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System K222028 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine. Cleared Oct 2022. https://www.510kdatabase.net/k222205/ 2022-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k222205-cold-sore-device-model-qpz-01-fda-510k.jpg K222205 - Cold Sore Device (Model: QPZ-01) K222205 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Light Tree Ventures Europe B.V.. Cleared Oct 2022. https://www.510kdatabase.net/k222369/ 2022-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k222369-pure-laser-fda-510k.jpg K222369 - PURE Laser K222369 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Endymed Medical, Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k222418/ 2022-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k222418-nuvola-fda-510k.jpg K222418 - Nuvola K222418 is a FDA 510(k) cleared dental medical device. Manufacturer: Gruppo Europeo Ortodonzia Srl. Cleared Oct 2022. https://www.510kdatabase.net/k222424/ 2022-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k222424-protect-it-custom-fit-dental-guard-fda-510k.jpg K222424 - Protect-It Custom Fit Dental Guard K222424 is a FDA 510(k) cleared dental medical device. Manufacturer: Doc Brands, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k222698/ 2022-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k222698-cuvis-spine-fda-510k.jpg K222698 - CUVIS-spine K222698 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Curexo, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k222714/ 2022-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k222714-nitrile-patient-examination-gloves-fda-510k.jpg K222714 - Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs K222714 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guangdong Kingfa Sci. & Tech.Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k211892/ 2022-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k211892-artfx-corpectomy-cages-espinax-and-fda-510k.jpg K211892 - ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) K211892 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arftx Medical, LLC. Cleared Oct 2022. https://www.510kdatabase.net/k212168/ 2022-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k212168-ad-medical-um-212ble-blood-pressure-fda-510k.jpg K212168 - A&D Medical UM-212BLE Blood Pressure Monitor K212168 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: A&D Company, Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k213666/ 2022-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k213666-nucath-wedge-pressure-catheter-fda-510k.jpg K213666 - NuCath Wedge Pressure Catheter K213666 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Pfm Medical, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k220365/ 2022-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k220365-gemini-sterilization-wrap-fda-510k.jpg K220365 - Gemini Sterilization Wrap K220365 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, LP. Cleared Oct 2022. https://www.510kdatabase.net/k220852/ 2022-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k220852-icare-ic200-fda-510k.jpg K220852 - iCare IC200 K220852 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Icare Finland OY. Cleared Oct 2022. https://www.510kdatabase.net/k221449/ 2022-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k221449-genius-ai-detection-20-fda-510k.jpg K221449 - Genius AI Detection 2.0 K221449 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hologic, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k221653/ 2022-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k221653-infatherm-disposable-infant-warming-fda-510k.jpg K221653 - InfaTherm Disposable Infant Warming Mattress K221653 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: International Biomedical. Cleared Oct 2022. https://www.510kdatabase.net/k221889/ 2022-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k221889-prosomnus-evo-ph-sleep-and-snore-fda-510k.jpg K221889 - ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring K221889 is a FDA 510(k) cleared dental medical device. Manufacturer: Prosomnus Sleep Technologies. Cleared Oct 2022. https://www.510kdatabase.net/k222080/ 2022-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k222080-garion-image-intensified-fluoroscopic-fda-510k.jpg K222080 - Garion Image-Intensified Fluoroscopic X-Ray System, Mobile K222080 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sg Healthcare Co, Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k222427/ 2022-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k222427-prima-tt-glenoid-fda-510k.jpg K222427 - PRIMA TT Glenoid K222427 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Lima Corporate S.P.A.. Cleared Oct 2022. https://www.510kdatabase.net/k222431/ 2022-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k222431-b-oner-mobio-total-knee-system-fda-510k.jpg K222431 - b-ONER MOBIO Total Knee System K222431 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: B-One Ortho, Corp.. Cleared Oct 2022. https://www.510kdatabase.net/k222686/ 2022-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k222686-perfit-fs-dental-zirconia-fully-fda-510k.jpg K222686 - Perfit FS Dental Zirconia Fully Sintered Block K222686 is a FDA 510(k) cleared dental medical device. Manufacturer: Vatech Acucera, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k222700/ 2022-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k222700-tibial-baseplate-tibial-insert-fda-510k.jpg K222700 - Tibial baseplate, Tibial insert K222700 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: United Orthopedic Corporation. Cleared Oct 2022. https://www.510kdatabase.net/k212779/ 2022-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k212779-coag-sense-prothrombin-pt-inr-fda-510k.jpg K212779 - Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing K212779 is a FDA 510(k) cleared hematology medical device. Manufacturer: Coagusense, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k220138/ 2022-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k220138-surtron-80-d-surtron-160-surtron-200-fda-510k.jpg K220138 - Surtron 80 D, Surtron 160, Surtron 200, Surtron Flash 160 HF, Surtron 400 HP K220138 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Led Spa. Cleared Oct 2022. https://www.510kdatabase.net/k220140/ 2022-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k220140-clearcorrect-system-fda-510k.jpg K220140 - ClearCorrect System K220140 is a FDA 510(k) cleared dental medical device. Manufacturer: Clearcorrect, LLC. Cleared Oct 2022. https://www.510kdatabase.net/k220546/ 2022-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k220546-colibr-system-fda-510k.jpg K220546 - Colibrí System K220546 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Copan Wasp Srl. Cleared Oct 2022. https://www.510kdatabase.net/k221128/ 2022-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k221128-arthrex-acl-tightrope-pcl-tightrope-fda-510k.jpg K221128 - Arthrex ACL TightRope®, PCL TightRope®, and TightRope® II K221128 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k221759/ 2022-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k221759-cornisol-fda-510k.jpg K221759 - Cornisol K221759 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Aurolab. Cleared Oct 2022. https://www.510kdatabase.net/k221892/ 2022-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k221892-visionair-fda-510k.jpg K221892 - VISIONAIR K221892 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Pacificmd Biotech, LLC. Cleared Oct 2022. https://www.510kdatabase.net/k222515/ 2022-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k222515-faset-fixation-system-fda-510k.jpg K222515 - FaSet Fixation System K222515 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Dio Medical Corporation. Cleared Oct 2022. https://www.510kdatabase.net/k222737/ 2022-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k222737-flexible-ureterorenoscope-model-us31e-fda-510k.jpg K222737 - Flexible Ureterorenoscope (Model: US31E-12-EU, US31E-12-US) K222737 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Shanghai AnQing Medical Instrument Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k213464/ 2022-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k213464-hemosil-liquid-anti-xa-fda-510k.jpg K213464 - HemosIL Liquid Anti-Xa K213464 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Oct 2022. https://www.510kdatabase.net/k220683/ 2022-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k220683-indigo-aspiration-system-cat-rx-fda-510k.jpg K220683 - INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4) K220683 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Penumbra, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k221066/ 2022-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k221066-sterile-hypodermic-needles-for-single-fda-510k.jpg K221066 - Sterile Hypodermic Needles for Single Use K221066 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sichuan Prius Biotechnology Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k221068/ 2022-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k221068-sterile-hypodermic-syringes-for-single-fda-510k.jpg K221068 - Sterile Hypodermic Syringes for Single Use with Needles K221068 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sichuan Prius Biotechnology Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k221073/ 2022-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k221073-sterile-hypodermic-syringes-for-single-fda-510k.jpg K221073 - Sterile Hypodermic Syringes for Single Use with Safety Needles K221073 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sichuan Prius Biotechnology Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k221079/ 2022-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k221079-sterile-hypodermic-syringes-for-single-fda-510k.jpg K221079 - Sterile Hypodermic Syringes for Single Use K221079 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sichuan Prius Biotechnology Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k221080/ 2022-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k221080-sterile-safety-hypodermic-needles-for-fda-510k.jpg K221080 - Sterile Safety Hypodermic Needles for Single Use K221080 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sichuan Prius Biotechnology Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k221517/ 2022-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k221517-polyvue-polymacon-soft-hydrophilic-fda-510k.jpg K221517 - POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lens K221517 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: INTEROJO, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k221646/ 2022-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k221646-cd-horizon-astute-spinal-system-fda-510k.jpg K221646 - CD HORIZON™ ASTUTE™ SPINAL SYSTEM K221646 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k221928/ 2022-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k221928-rosa-knee-system-fda-510k.jpg K221928 - ROSA® Knee System K221928 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthosoft D/B/A Zimmer Cas. Cleared Oct 2022. https://www.510kdatabase.net/k221994/ 2022-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k221994-hailie-sensor-nf0107-nf0108-fda-510k.jpg K221994 - Hailie Sensor NF0107 & NF0108 K221994 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Adherium (Nz), Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k222380/ 2022-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k222380-triverse-total-knee-replacement-system-fda-510k.jpg K222380 - TriVerse Total Knee Replacement System K222380 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Signature Orthopaedics Pty, Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k222743/ 2022-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k222743-route-92-medical-full-length-070-fda-510k.jpg K222743 - Route 92 Medical Full Length 070 Access System K222743 is a FDA 510(k) cleared neurology medical device. Manufacturer: Route 92 Medical, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k201237/ 2022-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k201237-velanovascularbloodcollectionadapter-fda-510k.jpg K201237 - Velano Vascular Blood Collection Adapter  K201237 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Velano Vascular. Cleared Oct 2022. https://www.510kdatabase.net/k202953/ 2022-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k202953-aurolase-therapy-laser-delivery-device-fda-510k.jpg K202953 - Aurolase Therapy, Laser Delivery Device (LDD) K202953 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Nanospectra Biosciences, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k212262/ 2022-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k212262-pca-syringe-sets-fda-510k.jpg K212262 - PCA Syringe Sets K212262 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corporation. Cleared Oct 2022. https://www.510kdatabase.net/k213014/ 2022-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k213014-varixis-elbow-system-fda-510k.jpg K213014 - Varixis Elbow System K213014 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Auxein Medical Private Limited. Cleared Oct 2022. https://www.510kdatabase.net/k213842/ 2022-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k213842-onvoy-acetabular-system-fda-510k.jpg K213842 - ONVOY Acetabular System K213842 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k220220/ 2022-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k220220-electronic-sphygmomanometer-model-lt-p30-fda-510k.jpg K220220 - Electronic Sphygmomanometer (Model: LT-P30) K220220 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Zhuhai Linte Medical Instrument Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k221047/ 2022-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k221047-silo-tfx-mis-sacroiliac-joint-fixation-fda-510k.jpg K221047 - SILO TFX MIS Sacroiliac Joint Fixation System K221047 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aurora Spine, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k221613/ 2022-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k221613-freestyle-lancing-device-ii-autolet-fda-510k.jpg K221613 - Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets K221613 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Owen Mumford, Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k221778/ 2022-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k221778-disposable-safety-lancets-fda-510k.jpg K221778 - Disposable Safety Lancets K221778 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Suzhou Kyuan Medical Apparatus Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k222267/ 2022-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k222267-arthrex-24-mm-volar-distal-radius-fda-510k.jpg K222267 - Arthrex 2.4 mm Volar Distal Radius Plate System K222267 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Oct 2022. https://www.510kdatabase.net/k222354/ 2022-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k222354-elastic-traction-system-fda-510k.jpg K222354 - Elastic Traction System K222354 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Micro-Tech (Nanjing) Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k222376/ 2022-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k222376-lianfa-safety-lancet-five-models-npa-fda-510k.jpg K222376 - Lianfa Safety Lancet (Five Models: NPA, PA, PA2, TPA, and APA) K222376 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shandong Lianfa Medical Plastic Products Co. , Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k222937/ 2022-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k222937-disposable-nitrile-examination-glove-fda-510k.jpg K222937 - Disposable Nitrile Examination Glove K222937 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Cureguard Glove Co., Ltd.. Cleared Oct 2022. https://www.510kdatabase.net/k200073/ 2022-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k200073-augmenta-penile-implant-fda-510k.jpg K200073 - AugMENTA Penile Implant K200073 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Augmenta, LLC. Cleared Sep 2022. https://www.510kdatabase.net/k210478/ 2022-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k210478-8mm-monopolar-curved-scissors-fda-510k.jpg K210478 - 8mm Monopolar Curved Scissors K210478 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Iconocare Health. Cleared Sep 2022. https://www.510kdatabase.net/k210567/ 2022-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k210567-ultrasonic-surgical-system-fda-510k.jpg K210567 - Ultrasonic Surgical System K210567 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Miconvey Technologies Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k211611/ 2022-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k211611-qir-suite-fda-510k.jpg K211611 - QIR Suite K211611 is a FDA 510(k) cleared radiology medical device. Manufacturer: Casis Cardiac Simulation & Imaging Software. Cleared Sep 2022. https://www.510kdatabase.net/k212316/ 2022-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k212316-doublechek-dc-1001-fda-510k.jpg K212316 - DoubleChek DC-1001 K212316 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Nasogastric Feeding Solutions, Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k213023/ 2022-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k213023-blood-pressure-monitormodely30001-fda-510k.jpg K213023 - Blood Pressure Monitor(Model:Y30001) K213023 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Zhangzhou Easepal Medical Science and Technology Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k213904/ 2022-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k213904-kerecis-oral-fda-510k.jpg K213904 - Kerecis Oral K213904 is a FDA 510(k) cleared dental medical device. Manufacturer: Kerecis. Cleared Sep 2022. https://www.510kdatabase.net/k220336/ 2022-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k220336-mg-psz-ceramic-femoral-head-fda-510k.jpg K220336 - Mg-PSZ Ceramic Femoral Head K220336 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Theken Companies. Cleared Sep 2022. https://www.510kdatabase.net/k220366/ 2022-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k220366-embedmed-fda-510k.jpg K220366 - EmbedMed K220366 is a FDA 510(k) cleared dental medical device. Manufacturer: 3D Lifeprints UK , Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k220758/ 2022-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k220758-e-ortho-shoulder-software-v11-fda-510k.jpg K220758 - e-Ortho Shoulder Software v1.1 K220758 is a FDA 510(k) cleared radiology medical device. Manufacturer: FH Industrie. Cleared Sep 2022. https://www.510kdatabase.net/k221003/ 2022-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k221003-autosuture-eea-stapler-circular-fda-510k.jpg K221003 - Autosuture EEA Stapler / circular stapler with DST Series Technology / EEA Autosuture Circular Stapler with DST Series Technology / DST Series EEA Stapler / DST EEA K221003 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien. Cleared Sep 2022. https://www.510kdatabase.net/k221243/ 2022-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k221243-ofnat-lubricant-l15-fda-510k.jpg K221243 - OFNat Lubricant (L15) K221243 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Suretex Limited. Cleared Sep 2022. https://www.510kdatabase.net/k221378/ 2022-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k221378-nitrile-powder-free-blue-patient-fda-510k.jpg K221378 - Nitrile Powder Free Blue Patient Examination Gloves, Non-Sterile K221378 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Tec Gloves Industry (M) Sdn.Bhd.. Cleared Sep 2022. https://www.510kdatabase.net/k222046/ 2022-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k222046-unscented-menstrual-tampon-fda-510k.jpg K222046 - Unscented Menstrual Tampon K222046 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Suzhou Borage Medical Technology Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k222090/ 2022-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k222090-safety-lancet-fda-510k.jpg K222090 - Safety Lancet K222090 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ningbo Medsun Medical Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k222206/ 2022-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k222206-air-compression-leg-massager-models-fda-510k.jpg K222206 - Air Compression Leg Massager (Models: S9036C, S9036B and S9036A) K222206 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Shenzhen Dongjilian Medical Tech Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k222244/ 2022-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k222244-arthrex-35-mm-locking-compression-plates-fda-510k.jpg K222244 - Arthrex 3.5 mm Locking Compression Plates K222244 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k222339/ 2022-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k222339-udr-380i-pro-fda-510k.jpg K222339 - uDR 380i Pro K222339 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k222625/ 2022-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k222625-shield-system-fda-510k.jpg K222625 - Shield System K222625 is a FDA 510(k) cleared radiology medical device. Manufacturer: Radiaction , Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k222849/ 2022-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k222849-amsco-600-steam-sterilizer-v-pro-max-2-fda-510k.jpg K222849 - AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector K222849 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Steris. Cleared Sep 2022. https://www.510kdatabase.net/k213034/ 2022-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k213034-spinear-snap-fda-510k.jpg K213034 - SpineAR SNAP K213034 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Surgical Theater, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k213126/ 2022-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k213126-smith-nephew-inc-plates-and-screws-fda-510k.jpg K213126 - Smith & Nephew, Inc. Plates and Screws Systems: EVOS, Peri-Loc, D-Rad, TC-100, VLP Mini-Mod, Compression Hip Screw (CHS), CONQUEST FN, and cannulated screws K213126 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k213417/ 2022-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k213417-ghost-spacer-system-fda-510k.jpg K213417 - Ghost Spacer System K213417 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k213716/ 2022-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k213716-innovaburn-fda-510k.jpg K213716 - InnovaBurn K213716 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Triad Life Sciences, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k220080/ 2022-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k220080-cognet-qmtriage-fda-510k.jpg K220080 - CogNet QmTRIAGE K220080 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medcognetics, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k221300/ 2022-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k221300-consona-n9-consona-n9-pro-consona-n9-fda-510k.jpg K221300 - Consona N9, Consona N9 Pro, Consona N9 Super, Consona Nova, Consona N9S, Consona NI, Consona NT, Nuewa N9, Recho N9, Consona N9 Exp, Consona N9 Elite, Resona N9, Consona N9T, Consona N8, Consona N8 Pro, Consona N8 Super, Consona OR, Consona N8S, Consona OI, Consona OT, Consona N8 Exp, Consona N8 Elite, Consona N8T, Consona N7, Consona N7 Pro, Consona N7 Super, Consona VR, Consona N7S, Consona VI, Consona VT, Consona N7 Exp, Consona N7 Elite, Consona N7T Diagnostic Ultrasound System K221300 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k221375/ 2022-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k221375-curesight-cs100-fda-510k.jpg K221375 - CureSight-CS100 K221375 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Novasight , Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k221496/ 2022-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k221496-consona-n6-consona-n6-pro-consona-n6-fda-510k.jpg K221496 - Consona N6, Consona N6 Pro, Consona N6 Super, Consona AR, Consona N6S, Consona AE, Consona AT, Consona N6 Exp Diagnostic Ultrasound System, Consona N6 Elite, Consona N6T Diagnostic Ultrasound System K221496 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k221637/ 2022-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k221637-surgical-gown-sterile-fda-510k.jpg K221637 - Surgical Gown (Sterile) K221637 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Allmed Medical (Hubei) Protective Products Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k221918/ 2022-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k221918-reflow-system-mini-fda-510k.jpg K221918 - ReFlow System Mini K221918 is a FDA 510(k) cleared neurology medical device. Manufacturer: Anuncia Medical, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k222005/ 2022-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k222005-sin-instrument-kits-fda-510k.jpg K222005 - S.I.N. Instrument Kits K222005 is a FDA 510(k) cleared general hospital medical device. Manufacturer: S.I.N. ? Sistema DE Implante Nacional S.A.. Cleared Sep 2022. https://www.510kdatabase.net/k222353/ 2022-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k222353-gm85-fda-510k.jpg K222353 - GM85 K222353 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Electronics Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k222383/ 2022-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k222383-anteralign-ls-spinal-system-with-titan-fda-510k.jpg K222383 - Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX Stealth(TM) Edition K222383 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k222605/ 2022-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k222605-ifuse-torq-implant-system-fda-510k.jpg K222605 - iFuse TORQ® Implant System K222605 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SI-BONE, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k222687/ 2022-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k222687-digital-radiography-cxdi-elite-digital-fda-510k.jpg K222687 - Digital Radiography CXDI-Elite, Digital Radiography E1 K222687 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/den200067/ 2022-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/den200067-innovance-vwf-ac-fda-510k.jpg DEN200067 - INNOVANCE VWF Ac DEN200067 is a FDA 510(k) cleared hematology medical device. Manufacturer: Siemens Healthcare Diagnostics Products GmbH. Cleared Sep 2022. https://www.510kdatabase.net/k211902/ 2022-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k211902-innovamatrix-pd-fda-510k.jpg K211902 - InnovaMatrix PD K211902 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Triad Life Sciences, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k212143/ 2022-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k212143-neteera-130h131h-vital-sign-monitoring-fda-510k.jpg K212143 - Neteera 130H/131H Vital Sign Monitoring Sensor K212143 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Neteera Technologies , Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k220081/ 2022-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k220081-core-sport-fda-510k.jpg K220081 - CORE-SPORT K220081 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Incore Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k220245/ 2022-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k220245-pocket-fetal-doppler-models-contec10c-fda-510k.jpg K220245 - Pocket Fetal Doppler (Models CONTEC10C and CONTEC10CL) K220245 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Contec Medical Systems Co.,Ltd. Cleared Sep 2022. https://www.510kdatabase.net/k221397/ 2022-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k221397-mitraclip-g4-steerable-guide-catheter-fda-510k.jpg K221397 - MitraClip G4 Steerable Guide Catheter K221397 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared Sep 2022. https://www.510kdatabase.net/k221548/ 2022-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k221548-dental-air-polishing-handpiece-fda-510k.jpg K221548 - Dental Air Polishing Handpiece K221548 is a FDA 510(k) cleared dental medical device. Manufacturer: Guilin Woodpecker Medical Instrument Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k221906/ 2022-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k221906-trojan-fire-ice-lubricated-male-fda-510k.jpg K221906 - TROJAN Fire & Ice lubricated male natural rubber latex condom K221906 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Church & Dwight Co., Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k222316/ 2022-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k222316-ipl-hair-removal-device-fda-510k.jpg K222316 - IPL Hair Removal Device K222316 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Goodwind Technology Development Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k222328/ 2022-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k222328-stericube-multiple-tray-sterilization-fda-510k.jpg K222328 - SteriCUBE® Multiple Tray Sterilization Systems K222328 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Stericube, LLC. Cleared Sep 2022. https://www.510kdatabase.net/k222329/ 2022-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k222329-briefcase-fda-510k.jpg K222329 - BriefCase K222329 is a FDA 510(k) cleared radiology medical device. Manufacturer: Aidoc Medical , Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k222442/ 2022-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k222442-disposable-vinyl-examination-gloves-fda-510k.jpg K222442 - DISPOSABLE VINYL EXAMINATION GLOVES (Pink, Black, Blue) K222442 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Anhui Bytech Medical Supplies Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k222482/ 2022-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k222482-agilon-xo-shoulder-system-fda-510k.jpg K222482 - AGILON XO Shoulder System K222482 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Implantcast GmbH. Cleared Sep 2022. https://www.510kdatabase.net/k222615/ 2022-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k222615-system-1e-liquid-chemical-sterilant-fda-510k.jpg K222615 - SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate K222615 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Sep 2022. https://www.510kdatabase.net/k222627/ 2022-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k222627-endogi-s-path-biliary-stent-system-fda-510k.jpg K222627 - EndoGI S-Path Biliary Stent System K222627 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Endo GI Medical. Cleared Sep 2022. https://www.510kdatabase.net/k212561/ 2022-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k212561-mtx-c1-fda-510k.jpg K212561 - MTX-C1 K212561 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ilooda Co,., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k213883/ 2022-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k213883-nanozoomer-s360md-slide-scanner-system-fda-510k.jpg K213883 - NanoZoomer S360MD Slide scanner system K213883 is a FDA 510(k) cleared pathology medical device. Manufacturer: Hamamatsu Photonics K.K.. Cleared Sep 2022. https://www.510kdatabase.net/k220342/ 2022-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k220342-xidf-aws801-angio-workstation-alphenix-fda-510k.jpg K220342 - XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3 K220342 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Sep 2022. https://www.510kdatabase.net/k220785/ 2022-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k220785-clean-connecting-tube-fda-510k.jpg K220785 - Clean Connecting Tube K220785 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Yangzhou Fartley Medical Instrument Technology Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k220831/ 2022-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k220831-dental-implantation-systems-dental-fda-510k.jpg K220831 - Dental Implantation Systems, Dental Electrical Motors K220831 is a FDA 510(k) cleared dental medical device. Manufacturer: Foshan Coxo Medical Instrument Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k221211/ 2022-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k221211-infrared-thermometer-fda-510k.jpg K221211 - Infrared thermometer K221211 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen Yolanda Technology Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k221360/ 2022-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k221360-medline-unite-medial-malleolus-peg-fda-510k.jpg K221360 - Medline UNITE® Medial Malleolus Peg Plate System K221360 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medline Industries, LP. Cleared Sep 2022. https://www.510kdatabase.net/k221738/ 2022-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k221738-ns-hglio-fda-510k.jpg K221738 - NS-HGlio K221738 is a FDA 510(k) cleared radiology medical device. Manufacturer: Neosoma, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k222648/ 2022-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k222648-5000-compact-series-ultrasound-systems-fda-510k.jpg K222648 - 5000 Compact Series Ultrasound Systems (Ultrasound System 5500 G, Ultrasound System 5500 P, Ultrasound System 5500 W, Ultrasound System 5500 CV, Ultrasound System 5300 G, Ultrasound System 5300 P, Ultrasound System 5300 W) K222648 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Ultrasound, LLC. Cleared Sep 2022. https://www.510kdatabase.net/k222661/ 2022-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k222661-digital-radiography-cxdi-cs01-fda-510k.jpg K222661 - Digital Radiography CXDI-CS01 K222661 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k214015/ 2022-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k214015-palm-nrg-cellulite-body-device-model-fda-510k.jpg K214015 - Palm NRG cellulite body device (model: Palm NRG body device) K214015 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Heat IN A Click, LLC. Cleared Sep 2022. https://www.510kdatabase.net/k220116/ 2022-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k220116-auryon-atherectomy-catheters-fda-510k.jpg K220116 - Auryon Atherectomy Catheters K220116 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Eximo Medical, Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k220795/ 2022-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k220795-qt-ecg-fda-510k.jpg K220795 - QT ECG K220795 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: QT Medical, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k221062/ 2022-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k221062-rightest-lancing-device-gd500-ge-fda-510k.jpg K221062 - RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device K221062 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bionime Corporation. Cleared Sep 2022. https://www.510kdatabase.net/k221473/ 2022-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k221473-flowart-fda-510k.jpg K221473 - Flowart K221473 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Asset Medikal Tasarim As.. Cleared Sep 2022. https://www.510kdatabase.net/k221631/ 2022-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k221631-tracheal-intubation-fiberscope-olympus-fda-510k.jpg K221631 - Tracheal Intubation Fiberscope OLYMPUS LF-P, VISERA Tracheal Intubation Videoscope OLYMPUS LF Type V K221631 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Sep 2022. https://www.510kdatabase.net/k222266/ 2022-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k222266-surgical-mask-gfm-96-gfm-91-gfm-90-gfm-fda-510k.jpg K222266 - Surgical Mask (GFM 96, GFM 91, GFM 90, GFM 88, GFM 81, GFM 80) K222266 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jingzhou Haixin Green Cross Medical Products Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k222602/ 2022-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k222602-pusen-single-use-flexible-video-fda-510k.jpg K222602 - Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope: PC200-AS, PC200-AR, PC200-S and PC200-R K222602 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Zhuhai Pusen Medical Technology Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k222655/ 2022-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k222655-otosight-middle-ear-scope-fda-510k.jpg K222655 - OtoSight Middle Ear Scope K222655 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Photonicare, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k222629/ 2022-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k222629-resonic-rapid-acoustic-pulse-device-fda-510k.jpg K222629 - Resonic Rapid Acoustic Pulse Device K222629 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Zeltiq Aesthetics, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k212751/ 2022-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k212751-powder-free-nitrile-examination-glove-fda-510k.jpg K212751 - Powder Free Nitrile Examination Glove K212751 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Dainam Glove Joint Stock Company. Cleared Sep 2022. https://www.510kdatabase.net/k221718/ 2022-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k221718-polyisoprene-powder-free-surgical-fda-510k.jpg K221718 - Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural) K221718 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hartalega NGC Sdn. Bhd.. Cleared Sep 2022. https://www.510kdatabase.net/k221887/ 2022-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k221887-nitrile-examination-glove-pink-color-fda-510k.jpg K221887 - Nitrile Examination Glove, Pink Color K221887 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guangdong Kingfa Sci. & Tech.Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k222294/ 2022-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k222294-black-nitrile-powder-free-patient-fda-510k.jpg K222294 - Black Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested for Use With Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl In Gastric Acid K222294 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Onetexx Sdn Bhd. Cleared Sep 2022. https://www.510kdatabase.net/k222342/ 2022-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k222342-betel-gloves-nitrile-examination-glove-fda-510k.jpg K222342 - Betel Gloves Nitrile Examination Glove Powder Free K222342 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Betel Care Sdn. Bhd.. Cleared Sep 2022. https://www.510kdatabase.net/k222693/ 2022-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k222693-single-use-medical-latex-examination-fda-510k.jpg K222693 - Single-use medical latex examination gloves (LG100) K222693 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Fitone Latex Products Co., Ltd. Guangdong. Cleared Sep 2022. https://www.510kdatabase.net/k202144/ 2022-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k202144-ab-dental-devices-dental-implants-system-fda-510k.jpg K202144 - A.B. Dental Devices Dental Implants System K202144 is a FDA 510(k) cleared dental medical device. Manufacturer: A.B. Dental Device , Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k213339/ 2022-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k213339-denu-composite-resin-denu-flow-resin-fda-510k.jpg K213339 - DENU Composite Resin, DENU Flow Resin K213339 is a FDA 510(k) cleared dental medical device. Manufacturer: Hdi, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k213759/ 2022-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k213759-xact-robotic-system-ace-model-fda-510k.jpg K213759 - XACT Robotic System, ACE Model K213759 is a FDA 510(k) cleared radiology medical device. Manufacturer: Xact Robotics, Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k220369/ 2022-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k220369-esthetic-colorant-fda-510k.jpg K220369 - Esthetic Colorant K220369 is a FDA 510(k) cleared dental medical device. Manufacturer: Kuraray Noritake Dental, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k220483/ 2022-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k220483-platform-acetabular-system-fda-510k.jpg K220483 - Platform® Acetabular System K220483 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Total Joint Orthopedics, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k220941/ 2022-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k220941-hotdog-temperature-management-system-fda-510k.jpg K220941 - HotDog Temperature Management System K220941 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Augustine Temperature Management. Cleared Sep 2022. https://www.510kdatabase.net/k221481/ 2022-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k221481-neutrart-fda-510k.jpg K221481 - NeutrArt K221481 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Asset Medikal Tasarim As.. Cleared Sep 2022. https://www.510kdatabase.net/k221724/ 2022-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k221724-conductive-gel-fda-510k.jpg K221724 - Conductive Gel K221724 is a FDA 510(k) cleared neurology medical device. Manufacturer: Tone-A-Matic International, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k221821/ 2022-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k221821-atec-iom-accessory-instruments-fda-510k.jpg K221821 - ATEC IOM Accessory Instruments K221821 is a FDA 510(k) cleared neurology medical device. Manufacturer: Alphatec Spine, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k221829/ 2022-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k221829-wet-flavored-personal-lubricants-fda-510k.jpg K221829 - Wet Flavored Personal Lubricants K221829 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Trigg Laboratories, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k222152/ 2022-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k222152-3m-attest-hydrogen-peroxide-indicator-fda-510k.jpg K222152 - 3M™ Attest™ Hydrogen Peroxide Indicator Tape 1228 K222152 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Sep 2022. https://www.510kdatabase.net/k222204/ 2022-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k222204-medical-surgical-mask-fda-510k.jpg K222204 - Medical Surgical Mask K222204 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guangzhou Zhengkang Medical Equipment Co.,Ltd. Cleared Sep 2022. https://www.510kdatabase.net/k222265/ 2022-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k222265-diosculpt-fda-510k.jpg K222265 - Diosculpt K222265 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd. Cleared Sep 2022. https://www.510kdatabase.net/k222555/ 2022-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k222555-reepot-nd-fda-510k.jpg K222555 - reepot Nd K222555 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ilooda Co,., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k222561/ 2022-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k222561-align-fda-510k.jpg K222561 - Align K222561 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Acuity Surgical Devices, LLC. Cleared Sep 2022. https://www.510kdatabase.net/k222568/ 2022-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k222568-opticross-18-peripheral-imaging-catheter-fda-510k.jpg K222568 - OptiCross™ 18 Peripheral Imaging Catheter K222568 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Sep 2022. https://www.510kdatabase.net/k222877/ 2022-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k222877-freeprint-crown-fda-510k.jpg K222877 - FREEPRINT crown K222877 is a FDA 510(k) cleared dental medical device. Manufacturer: Detax GmbH. Cleared Sep 2022. https://www.510kdatabase.net/k211605/ 2022-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k211605-dual-switch-fda-510k.jpg K211605 - Dual Switch K211605 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Laser Engineering, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k212197/ 2022-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k212197-washercap-fixation-system-fda-510k.jpg K212197 - WasherCap Fixation System K212197 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Abanza Tecnomed S.L. Cleared Sep 2022. https://www.510kdatabase.net/k213674/ 2022-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k213674-cellfx-system-fda-510k.jpg K213674 - CellFX System K213674 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Pulse Biosciences, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k214125/ 2022-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k214125-tranberg-thermoguide-therapy-system-fda-510k.jpg K214125 - TRANBERG Thermoguide Therapy System K214125 is a FDA 510(k) cleared neurology medical device. Manufacturer: Clinical Laserthermia Systems, AB. Cleared Sep 2022. https://www.510kdatabase.net/k220089/ 2022-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k220089-disposable-polyp-snare-fda-510k.jpg K220089 - Disposable Polyp Snare K220089 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Jiangsu Vedkang Medical Science and Technology Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k220540/ 2022-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k220540-progrip-self-gripping-polypropylene-mesh-fda-510k.jpg K220540 - ProGrip Self-Gripping Polypropylene Mesh K220540 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien. Cleared Sep 2022. https://www.510kdatabase.net/k220681/ 2022-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k220681-talee-talee-postop-fda-510k.jpg K220681 - Talee, Talee PostOP K220681 is a FDA 510(k) cleared neurology medical device. Manufacturer: Invent Medical USA, LLC. Cleared Sep 2022. https://www.510kdatabase.net/k222224/ 2022-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k222224-surgilance-safety-lancet-fda-510k.jpg K222224 - SurgiLance® Safety Lancet K222224 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medipurpose Pte. , Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k222253/ 2022-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k222253-glasionomer-fx-ultra-fda-510k.jpg K222253 - GlasIonomer FX ULTRA K222253 is a FDA 510(k) cleared dental medical device. Manufacturer: Shofu Dental Corporation. Cleared Sep 2022. https://www.510kdatabase.net/k222804/ 2022-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k222804-irrisept-antimicrobial-wound-lavage-fda-510k.jpg K222804 - Irrisept Antimicrobial Wound Lavage K222804 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Irrimax Corporation. Cleared Sep 2022. https://www.510kdatabase.net/k210475/ 2022-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k210475-eq-m-fda-510k.jpg K210475 - EQ-M K210475 is a FDA 510(k) cleared dental medical device. Manufacturer: Meta Systems Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k212359/ 2022-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k212359-pwd-negative-pressure-wound-therapy-fda-510k.jpg K212359 - PWD Negative Pressure Wound Therapy System K212359 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Applied Tissue Technologies, LLC. Cleared Sep 2022. https://www.510kdatabase.net/k212615/ 2022-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k212615-epifaith-cv-fda-510k.jpg K212615 - EpiFaith CV K212615 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Flat Medical Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k213379/ 2022-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k213379-clearblue-early-pregnancy-test-fda-510k.jpg K213379 - Clearblue ® Early Pregnancy Test K213379 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Spd Swiss Precision Diagnostics GmbH. Cleared Sep 2022. https://www.510kdatabase.net/k220236/ 2022-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k220236-v-print-dentbase-fda-510k.jpg K220236 - V-Print dentbase K220236 is a FDA 510(k) cleared dental medical device. Manufacturer: Voco GmbH. Cleared Sep 2022. https://www.510kdatabase.net/k220607/ 2022-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k220607-bd-max-enteric-viral-panel-fda-510k.jpg K220607 - BD MAX Enteric Viral Panel K220607 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson and Company. Cleared Sep 2022. https://www.510kdatabase.net/k221179/ 2022-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k221179-somnometry-fda-510k.jpg K221179 - SomnoMetry K221179 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neumetry Medical, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k221214/ 2022-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k221214-hand-held-ipl-device-ipl-home-use-hair-fda-510k.jpg K221214 - Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100, FZ-200 K221214 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Ionka Medical Technology Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k221383/ 2022-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k221383-medtfine-blood-lancet-fda-510k.jpg K221383 - MedtFine Blood Lancet K221383 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shanghai Carelife International Trading Co. , Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k222059/ 2022-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k222059-speedicath-flex-set-fda-510k.jpg K222059 - SpeediCath Flex Set K222059 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Coloplast. Cleared Sep 2022. https://www.510kdatabase.net/k222293/ 2022-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k222293-arcsp-suprapubic-sling-system-fda-510k.jpg K222293 - ArcSP Suprapubic Sling System K222293 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Urocure, LLC. Cleared Sep 2022. https://www.510kdatabase.net/k222542/ 2022-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k222542-mcb-unit-model-v10gmcbus-fda-510k.jpg K222542 - MCB UNIT Model: V10GMCBUS K222542 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Lamidey Noury Medical. Cleared Sep 2022. https://www.510kdatabase.net/k213353/ 2022-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k213353-aorta-cad-fda-510k.jpg K213353 - Aorta-CAD K213353 is a FDA 510(k) cleared radiology medical device. Manufacturer: Imagen Technologies, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k213598/ 2022-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k213598-luofucon-collagen-wound-dressing-fda-510k.jpg K213598 - LUOFUCON Collagen Wound Dressing K213598 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Huizhou Foryou Medical Devices Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k214048/ 2022-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k214048-millipede-088-access-catheter-fda-510k.jpg K214048 - Millipede 088 Access Catheter K214048 is a FDA 510(k) cleared neurology medical device. Manufacturer: Perfuze, Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k214056/ 2022-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k214056-disposable-nitrile-inspection-gloves-fda-510k.jpg K214056 - Disposable Nitrile Inspection Gloves (Tested for Use with Chemotherapy Drugs) K214056 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Mezorrison Medical Technology (Dongying) Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k220359/ 2022-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k220359-tandry-compression-screw-system-fda-510k.jpg K220359 - Tandry Compression Screw System K220359 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Microware Precision Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k221227/ 2022-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k221227-tuttnauer-horizontal-autoclave-series-fda-510k.jpg K221227 - Tuttnauer Horizontal autoclave series model: 4472, 5596, 6690, 66120 K221227 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Tuttnauer , Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k221717/ 2022-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k221717-disposable-surgical-gown-um-148-fda-510k.jpg K221717 - Disposable Surgical Gown UM-148 K221717 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Unimax Medical Products Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k221809/ 2022-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k221809-depuy-synthes-35mm-intrapelvic-fda-510k.jpg K221809 - DePuy Synthes 3.5mm Intrapelvic Acetabular System K221809 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Synthes. Cleared Sep 2022. https://www.510kdatabase.net/k221908/ 2022-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k221908-jo-cumplay-personal-lubricant-fda-510k.jpg K221908 - JO CUMPLAY Personal Lubricant K221908 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: CC Wellness, LLC. Cleared Sep 2022. https://www.510kdatabase.net/k221976/ 2022-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k221976-surgical-face-mask-non-sterile-fda-510k.jpg K221976 - Surgical Face Mask (Non-sterile) K221976 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Xiantao Junhui Plastic Products Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k222642/ 2022-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k222642-disposable-nitrile-examination-fda-510k.jpg K222642 - Disposable Nitrile Examination Glove(Tested for use with Chemotherapy Drug) K222642 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Inner Mongolia Cureguard Medical Technology Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k213013/ 2022-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k213013-sterile-single-use-ldv-syringe-fda-510k.jpg K213013 - Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use LDV Syringe K213013 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jeil Tech Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k213897/ 2022-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k213897-pro-m-class-fda-510k.jpg K213897 - Pro M Class K213897 is a FDA 510(k) cleared dental medical device. Manufacturer: Saeyang Microtech Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k214060/ 2022-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k214060-landmark-reboa-catheter-fda-510k.jpg K214060 - LANDMARK REBOA Catheter K214060 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Zien Medical Technologies, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k220129/ 2022-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k220129-promisemed-x-safety-pen-needle-fda-510k.jpg K220129 - Promisemed X-Safety Pen Needle K220129 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Promisemed Hangzhou Meditech Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k220839/ 2022-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k220839-arthrex-compression-ft-pins-fda-510k.jpg K220839 - Arthrex Compression FT Pins K220839 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k221638/ 2022-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k221638-rhino-laryngo-videoscope-olympus-enf-fda-510k.jpg K221638 - Rhino-Laryngo Videoscope Olympus ENF-VH, Rhino-Laryngo Videoscope Olympus ENF-V3 K221638 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Sep 2022. https://www.510kdatabase.net/k221819/ 2022-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k221819-35g-standard-smms-surgical-gown-fda-510k.jpg K221819 - 35g Standard SMMS Surgical Gown K221819 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Winner Medical Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k221839/ 2022-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k221839-lancet-fda-510k.jpg K221839 - Lancet K221839 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Hebei Xinle Sci&Tech Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k222121/ 2022-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k222121-c630g-lcd-monitor-jusha-c630g-lcd-fda-510k.jpg K222121 - C630G LCD monitor, JUSHA-C630G LCD monitor, C630 LCD monitor, JUSHA-C630 LCD monitor K222121 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nanjing Jusha Display Technology Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k222131/ 2022-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k222131-nb-1-sa-implant-system-fda-510k.jpg K222131 - NB 1 SA Implant System K222131 is a FDA 510(k) cleared dental medical device. Manufacturer: Arum Dentistry Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k202929/ 2022-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k202929-nexpowder-fda-510k.jpg K202929 - Nexpowder K202929 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Nextbiomedical Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k211027/ 2022-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k211027-altus-spine-pedicle-screw-system-fda-510k.jpg K211027 - Altus Spine Pedicle Screw System K211027 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Altus Partners, LLC. Cleared Sep 2022. https://www.510kdatabase.net/k212217/ 2022-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k212217-tempo-smart-button-fda-510k.jpg K212217 - Tempo Smart Button K212217 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Eli Lilly and Company. Cleared Sep 2022. https://www.510kdatabase.net/k212926/ 2022-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k212926-alluretm-surgical-mask-fda-510k.jpg K212926 - AllureTM Surgical Mask K212926 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Allure Gift Wraps Private Limited. Cleared Sep 2022. https://www.510kdatabase.net/k220134/ 2022-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k220134-cobas-pure-integrated-solutions-fda-510k.jpg K220134 - cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH K220134 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Sep 2022. https://www.510kdatabase.net/k220297/ 2022-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k220297-true-tulip-true-mis-fda-510k.jpg K220297 - True Tulip, True M.I.S. K220297 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Innovative Surgical Designs, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k220339/ 2022-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k220339-esthetic-abutments-nobel-biocare-n1-fda-510k.jpg K220339 - Esthetic Abutments Nobel Biocare N1 K220339 is a FDA 510(k) cleared dental medical device. Manufacturer: Nobel Biocare Services AG. Cleared Sep 2022. https://www.510kdatabase.net/k220441/ 2022-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k220441-cygnus-more-anterior-cervical-plate-fda-510k.jpg K220441 - CYGNUS™ MoRe Anterior Cervical Plate System K220441 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: MiRus, LLC. Cleared Sep 2022. https://www.510kdatabase.net/k220553/ 2022-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k220553-neuro-omega-system-neurosmart-system-fda-510k.jpg K220553 - Neuro Omega System, NeuroSmart System K220553 is a FDA 510(k) cleared neurology medical device. Manufacturer: Alpha Omega Engineering , Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k220969/ 2022-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k220969-gelpoint-v-path-vaginal-access-system-fda-510k.jpg K220969 - GelPOINT V-Path Vaginal Access System K220969 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Applied Medical Resources Corporation. Cleared Sep 2022. https://www.510kdatabase.net/k221074/ 2022-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k221074-optablate-rf-generator-optablate-fda-510k.jpg K221074 - OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device K221074 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker Corporation. Cleared Sep 2022. https://www.510kdatabase.net/k221194/ 2022-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k221194-ledex-fda-510k.jpg K221194 - LEDEX K221194 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentmate Technology Co. , Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k221249/ 2022-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k221249-l1p-1f-trios-5-fda-510k.jpg K221249 - L1P-1F (TRIOS 5) K221249 is a FDA 510(k) cleared dental medical device. Manufacturer: 3Shape TRIOS A/S. Cleared Sep 2022. https://www.510kdatabase.net/k221343/ 2022-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k221343-echelon-endopath-staple-line-fda-510k.jpg K221343 - ECHELON ENDOPATH Staple Line Reinforcement K221343 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon Endo-Surgery, LLC. Cleared Sep 2022. https://www.510kdatabase.net/k221534/ 2022-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k221534-surgical-face-masks-ear-loops-and-tie-on-fda-510k.jpg K221534 - Surgical Face Masks (Ear Loops And Tie-On) K221534 is a FDA 510(k) cleared general hospital medical device. Manufacturer: San-M Package Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k221676/ 2022-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k221676-exsalta-fda-510k.jpg K221676 - Exsalta K221676 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Drw Medical. Cleared Sep 2022. https://www.510kdatabase.net/k221799/ 2022-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k221799-electric-wheelchair-model-9000n-fda-510k.jpg K221799 - Electric Wheelchair, Model: 9000N K221799 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Silver Fox Corporation Limited. Cleared Sep 2022. https://www.510kdatabase.net/k222155/ 2022-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k222155-single-use-o-ring-gasket-syringe-with-fda-510k.jpg K222155 - Single Use O-ring gasket syringe with ENFit Connector, Reusable O-ring gasket syringe with ENFit connector K222155 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Jiangsu Caina Medical Co.,Ltd. Cleared Sep 2022. https://www.510kdatabase.net/k222519/ 2022-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k222519-clearpoint-system-fda-510k.jpg K222519 - ClearPoint System K222519 is a FDA 510(k) cleared neurology medical device. Manufacturer: ClearPoint Neuro, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/den220025/ 2022-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/den220025-phagenyx-system-fda-510k.jpg DEN220025 - Phagenyx System DEN220025 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Phagenesis Limited. Cleared Sep 2022. https://www.510kdatabase.net/k203336/ 2022-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k203336-thermo-scientific-oxoid-omadacycline-fda-510k.jpg K203336 - Thermo Scientific Oxoid Omadacycline Disc (30 ug) OMC30 K203336 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Oxoid Limited (Part of Thermo Fisher Scientific). Cleared Sep 2022. https://www.510kdatabase.net/k211204/ 2022-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k211204-safeporttm-manifold-or-stopcock-fda-510k.jpg K211204 - SafePort(TM) Manifold (or Stopcock) K211204 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Elcam Medical Acal. Cleared Sep 2022. https://www.510kdatabase.net/k213641/ 2022-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k213641-mondrian-alif-cage-with-supplementary-fda-510k.jpg K213641 - MONDRIAN ALIF Cage with Supplementary Fixation Plate K213641 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ctl Medical Corporation. Cleared Sep 2022. https://www.510kdatabase.net/k213856/ 2022-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k213856-identity-shoulder-system-fda-510k.jpg K213856 - Identity Shoulder System K213856 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k220176/ 2022-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k220176-elecsys-afp-fda-510k.jpg K220176 - Elecsys AFP K220176 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics. Cleared Sep 2022. https://www.510kdatabase.net/k220697/ 2022-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k220697-nitrile-patient-examination-gloves-fda-510k.jpg K220697 - Nitrile Patient Examination Gloves, Powder Free K220697 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Lalan Rubbers (Pvt), Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k220830/ 2022-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k220830-truebalance-surgical-system-fda-510k.jpg K220830 - TrueBalance™ Surgical System K220830 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: These Three Medical, LLC. Cleared Sep 2022. https://www.510kdatabase.net/k221089/ 2022-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k221089-p12-elite-series-digital-color-doppler-fda-510k.jpg K221089 - P12 Elite Series Digital Color Doppler Ultrasound System K221089 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sonoscape Medical Corp.. Cleared Sep 2022. https://www.510kdatabase.net/k221553/ 2022-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k221553-diamond-air-ui04a-ui04b-ui04c-fda-510k.jpg K221553 - Diamond Air+ (UI04A, UI04B, UI04C) K221553 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ulike Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k221597/ 2022-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k221597-co2-laser-system-fda-510k.jpg K221597 - CO2 Laser System K221597 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smedtrum Medical Technology Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k221686/ 2022-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k221686-novosorb-matrix-fda-510k.jpg K221686 - NovoSorb Matrix K221686 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Polynovo Biomaterials Pty, Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k221966/ 2022-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k221966-dynamic-tibase-fda-510k.jpg K221966 - Dynamic TiBase K221966 is a FDA 510(k) cleared dental medical device. Manufacturer: Talladium Espana, SL. Cleared Sep 2022. https://www.510kdatabase.net/k221968/ 2022-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k221968-stageone-shoulder-cement-spacer-molds-fda-510k.jpg K221968 - StageOne™ Shoulder Cement Spacer Molds K221968 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k222468/ 2022-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k222468-arcto-transobturator-sling-system-fda-510k.jpg K222468 - ArcTO Transobturator Sling System K222468 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Urocure, LLC. Cleared Sep 2022. https://www.510kdatabase.net/k222500/ 2022-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k222500-air-optix-colors-fda-510k.jpg K222500 - AIR OPTIX COLORS K222500 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Alcon Laboratories, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k201049/ 2022-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k201049-finder-g6pd-fda-510k.jpg K201049 - FINDER G6PD K201049 is a FDA 510(k) cleared hematology medical device. Manufacturer: Baebies, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k212618/ 2022-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k212618-irelieve-microcurrent-pain-relief-system-fda-510k.jpg K212618 - iRelieve Microcurrent Pain Relief System K212618 is a FDA 510(k) cleared neurology medical device. Manufacturer: Fast Track Technologies, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k213293/ 2022-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k213293-v-hepes-plus-fda-510k.jpg K213293 - V-HEPES PLUS K213293 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Vitromed Langenfeld. Cleared Sep 2022. https://www.510kdatabase.net/k213854/ 2022-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k213854-savvywire-fda-510k.jpg K213854 - SavvyWire K213854 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Opsens, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k220418/ 2022-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k220418-tornier-perform-humeral-system-stemless-fda-510k.jpg K220418 - Tornier Perform Humeral System – Stemless K220418 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tornier, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k220978/ 2022-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k220978-tsx-implants-fda-510k.jpg K220978 - TSX Implants K220978 is a FDA 510(k) cleared dental medical device. Manufacturer: Biomet 3i, LLC. Cleared Sep 2022. https://www.510kdatabase.net/k220979/ 2022-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k220979-sprintray-denture-base-fda-510k.jpg K220979 - SprintRay Denture Base K220979 is a FDA 510(k) cleared dental medical device. Manufacturer: Sprintray, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k220990/ 2022-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k220990-qorda-qd1-fda-510k.jpg K220990 - Qorda QD1 K220990 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Winix, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k221707/ 2022-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k221707-safesept-transseptal-guidewire-ss-140-fda-510k.jpg K221707 - SafeSept® Transseptal Guidewire (SS-140) K221707 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Pressure Products Medical Device Manufacturing, LLC. Cleared Sep 2022. https://www.510kdatabase.net/k221761/ 2022-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k221761-solea-fda-510k.jpg K221761 - Solea K221761 is a FDA 510(k) cleared dental medical device. Manufacturer: Convergent Dental, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k221797/ 2022-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k221797-bravos-afterloader-family-bravos-fda-510k.jpg K221797 - BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes and Length Assessment Device K221797 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k221843/ 2022-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k221843-gem-biover-microvascular-clamps-fda-510k.jpg K221843 - GEM Biover Microvascular Clamps K221843 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Synovis Micro Companies Alliance, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k222078/ 2022-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k222078-arthrex-softstitch-fda-510k.jpg K222078 - Arthrex SoftStitch K222078 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Arthrex, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k222091/ 2022-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k222091-grappler-suture-anchor-system-fda-510k.jpg K222091 - Grappler Suture Anchor System K222091 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paragon 28, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k222331/ 2022-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k222331-watchpat300-wp300-fda-510k.jpg K222331 - WatchPAT300 (WP300) K222331 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Itamar Medical , Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k222503/ 2022-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k222503-resolution-clip-resolution-360-clip-fda-510k.jpg K222503 - Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip K222503 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Sep 2022. https://www.510kdatabase.net/k222764/ 2022-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k222764-lightforce-orthodontic-system-fda-510k.jpg K222764 - LightForce Orthodontic System K222764 is a FDA 510(k) cleared dental medical device. Manufacturer: Lightforce Orthodontics. Cleared Sep 2022. https://www.510kdatabase.net/k210929/ 2022-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k210929-magicath-ii-fda-510k.jpg K210929 - MagiCath II K210929 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Woo Young Medical Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k212147/ 2022-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k212147-simplexa-covid-19-direct-fda-510k.jpg K212147 - Simplexa COVID-19 Direct K212147 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Diasorin Molecular, LLC. Cleared Sep 2022. https://www.510kdatabase.net/k213575/ 2022-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k213575-female-ic-not-finalized-fda-510k.jpg K213575 - Female IC (Not Finalized) K213575 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hollister Incorporated. Cleared Sep 2022. https://www.510kdatabase.net/k213770/ 2022-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k213770-sp-cl-hip-stem-and-lcu-hip-system-fda-510k.jpg K213770 - SP-CL Hip Stem and LCU Hip System K213770 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Waldemar Link GmbH & Co. KG. Cleared Sep 2022. https://www.510kdatabase.net/k214035/ 2022-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k214035-laitest-medical-face-mask-fda-510k.jpg K214035 - LAITEST Medical Face Mask K214035 is a FDA 510(k) cleared general hospital medical device. Manufacturer: R&R Medical Corporation, Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k220239/ 2022-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k220239-solid-state-x-ray-imagermodel-fxrd-fda-510k.jpg K220239 - Solid State X-ray Imager(Model: FXRD-4386WB) K220239 is a FDA 510(k) cleared radiology medical device. Manufacturer: Vieworks Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k220953/ 2022-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k220953-choicespine-tigershark-m-modular-fda-510k.jpg K220953 - ChoiceSpine TigerShark™ M, Modular Interbody System K220953 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Choice Spine, LLC. Cleared Sep 2022. https://www.510kdatabase.net/k221092/ 2022-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k221092-transcutaneous-electrical-nerve-fda-510k.jpg K221092 - Transcutaneous Electrical Nerve Stimulator Model: ST-304 K221092 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Future Electronic Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k221140/ 2022-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k221140-p20-elite-series-digital-color-doppler-fda-510k.jpg K221140 - P20 Elite Series Digital Color Doppler Ultrasound System K221140 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sonoscape Medical Corp.. Cleared Sep 2022. https://www.510kdatabase.net/k221417/ 2022-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k221417-clarox-plus-model-vx-100-fda-510k.jpg K221417 - CLAROX plus (Model: VX-100) K221417 is a FDA 510(k) cleared radiology medical device. Manufacturer: Vsi Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k221425/ 2022-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k221425-primary-relief-fda-510k.jpg K221425 - Primary Relief K221425 is a FDA 510(k) cleared neurology medical device. Manufacturer: Dyansys, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k221733/ 2022-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k221733-magnetom-sola-magnetom-altea-magnetom-fda-510k.jpg K221733 - MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit K221733 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k221748/ 2022-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k221748-medispo-rubber-surgical-gloves-medispo-fda-510k.jpg K221748 - Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves K221748 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guilin Hbm Health Protections, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k214024/ 2022-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k214024-sofia-88-catheter-fda-510k.jpg K214024 - SOFIA 88 Catheter K214024 is a FDA 510(k) cleared neurology medical device. Manufacturer: MicroVention, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k220084/ 2022-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k220084-infrared-forehead-thermometer-fda-510k.jpg K220084 - Infrared Forehead Thermometer K220084 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Qingdao Yasee Medical Device Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k220986/ 2022-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k220986-aquilion-precision-tsx-304a4-v1010-fda-510k.jpg K220986 - Aquilion Precision (TSX-304A/4) V10.10 with AiCE K220986 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Sep 2022. https://www.510kdatabase.net/k221450/ 2022-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k221450-phosphoric-acid-etching-gel-fda-510k.jpg K221450 - Phosphoric Acid Etching Gel K221450 is a FDA 510(k) cleared dental medical device. Manufacturer: Rizhao Huge Biomaterials Company, Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k221456/ 2022-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k221456-rapid-ich-fda-510k.jpg K221456 - Rapid ICH K221456 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ischemaview, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k221533/ 2022-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k221533-plasma-shield-fda-510k.jpg K221533 - Plasma Shield K221533 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Plasmatica, Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k221568/ 2022-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k221568-kolo-evolution-xhd-series-ultrasound-fda-510k.jpg K221568 - KOLO Evolution XHD Series Ultrasound Diagnostic System K221568 is a FDA 510(k) cleared radiology medical device. Manufacturer: Kolo Medical (Suzhou) Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k222512/ 2022-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k222512-integrity-si-fusion-system-fda-510k.jpg K222512 - Integrity-SI Fusion System K222512 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OsteoCentric Technologies. Cleared Sep 2022. https://www.510kdatabase.net/k213244/ 2022-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k213244-accusil-dental-impression-materials-fda-510k.jpg K213244 - Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration) K213244 is a FDA 510(k) cleared dental medical device. Manufacturer: Prevest Denpro Limited. Cleared Sep 2022. https://www.510kdatabase.net/k214028/ 2022-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k214028-micor-lens-fragmentation-system-fda-510k.jpg K214028 - MICOR Lens Fragmentation System K214028 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Carl Zeiss Meditec Cataract Technology, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k220002/ 2022-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k220002-dexus-prosthetics-system-model-msl1-msr1-fda-510k.jpg K220002 - Dexus Prosthetics System (Model: MSL1, MSR1) K220002 is a FDA 510(k) cleared neurology medical device. Manufacturer: Zhejiang Qiangnao Technology Co.,Ltd. Cleared Sep 2022. https://www.510kdatabase.net/k220659/ 2022-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k220659-autobahnr-evo-femoral-nails-fda-510k.jpg K220659 - AUTOBAHN(R) EVO Femoral Nails K220659 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k220859/ 2022-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k220859-powder-free-nitrile-examination-gloves-fda-510k.jpg K220859 - Powder Free Nitrile Examination Gloves, Colored (Green, Orange, Purple, White, & Black) K220859 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Careglove Global Sdn. Bhd.. Cleared Sep 2022. https://www.510kdatabase.net/k220944/ 2022-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k220944-pointcore-surgical-mask-fda-510k.jpg K220944 - PointCore Surgical Mask K220944 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Pointcore, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k221354/ 2022-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k221354-arthrex-suturetape-fda-510k.jpg K221354 - Arthrex SutureTape K221354 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Arthrex, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k221388/ 2022-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k221388-nuvasive-reline-cervical-system-fda-510k.jpg K221388 - NuVasive Reline Cervical System K221388 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Sep 2022. https://www.510kdatabase.net/k222093/ 2022-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k222093-v-pro-max-2-low-temperature-fda-510k.jpg K222093 - V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System K222093 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Steris. Cleared Sep 2022. https://www.510kdatabase.net/k222429/ 2022-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k222429-ellusa-reusable-bipolar-cable-fda-510k.jpg K222429 - Ellusa Reusable Bipolar Cable K222429 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ellusa, LLC. Cleared Sep 2022. https://www.510kdatabase.net/k222440/ 2022-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k222440-vis-u-all-low-temperature-fda-510k.jpg K222440 - Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays K222440 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Steris. Cleared Sep 2022. https://www.510kdatabase.net/k222723/ 2022-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k222723-ambarino-high-class-fda-510k.jpg K222723 - AMBARINO High-Class K222723 is a FDA 510(k) cleared dental medical device. Manufacturer: Creamed GmbH & Co. Produktions- Und Handels KG. Cleared Sep 2022. https://www.510kdatabase.net/k210973/ 2022-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k210973-mammaprint-ffpe-ngs-kit-fda-510k.jpg K210973 - MammaPrint FFPE NGS Kit K210973 is a FDA 510(k) cleared pathology medical device. Manufacturer: Agendia, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k211648/ 2022-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k211648-diazyme-human-kappa-free-light-chain-fda-510k.jpg K211648 - Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay K211648 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diazyme Laboratories, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k213267/ 2022-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k213267-dynamis-pro-family-fda-510k.jpg K213267 - Dynamis Pro Family K213267 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Fotona D.O.O.. Cleared Sep 2022. https://www.510kdatabase.net/k213947/ 2022-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k213947-ultrasonic-endo-activation-device-fda-510k.jpg K213947 - Ultrasonic Endo Activation Device (Model:Actor I pro) K213947 is a FDA 510(k) cleared dental medical device. Manufacturer: Changzhou Bomedent Medical Technology Co.,Ltd. Cleared Sep 2022. https://www.510kdatabase.net/k213989/ 2022-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k213989-cranial-em-system-fda-510k.jpg K213989 - Cranial EM System K213989 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Sep 2022. https://www.510kdatabase.net/k220143/ 2022-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k220143-barbie-polymacon-daily-wear-soft-fda-510k.jpg K220143 - BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens K220143 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Shenzhen Dashicheng Optical Technology Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k220330/ 2022-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k220330-soundly-anti-snoring-device-fda-510k.jpg K220330 - Soundly Anti Snoring Device K220330 is a FDA 510(k) cleared dental medical device. Manufacturer: Greystone Ip, Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k220595/ 2022-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k220595-neonavia-biopsy-system-fda-510k.jpg K220595 - NeoNavia Biopsy System K220595 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Neodynamics AB. Cleared Sep 2022. https://www.510kdatabase.net/k221331/ 2022-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k221331-disposable-endoscope-valves-system-fda-510k.jpg K221331 - Disposable Endoscope Valves System K221331 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Changzhou Endoclean Medical Device Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k221684/ 2022-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k221684-osstem-abutment-system-fda-510k.jpg K221684 - Osstem Abutment System K221684 is a FDA 510(k) cleared dental medical device. Manufacturer: Osstem Implant Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k222020/ 2022-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k222020-hd-550-video-endoscope-system-fda-510k.jpg K222020 - HD-550 Video Endoscope System K222020 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Sonoscape Medical Corp.. Cleared Sep 2022. https://www.510kdatabase.net/k222076/ 2022-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k222076-efai-chestsuite-xr-pleural-effusion-fda-510k.jpg K222076 - EFAI ChestSuite XR Pleural Effusion Assessment System K222076 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ever Fortune.Ai, Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k222409/ 2022-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k222409-captivate-compression-screws-fda-510k.jpg K222409 - CAPTIVATE® Compression Screws K222409 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k222425/ 2022-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k222425-ellusa-reusable-neutral-plates-fda-510k.jpg K222425 - Ellusa Reusable Neutral Plates K222425 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ellusa, LLC. Cleared Sep 2022. https://www.510kdatabase.net/k203594/ 2022-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k203594-eyectester-fda-510k.jpg K203594 - EyeCTester K203594 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Neuro-Eye Diagnostic Systems, LLC. Cleared Sep 2022. https://www.510kdatabase.net/k220112/ 2022-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k220112-axios-stent-and-electrocautery-fda-510k.jpg K220112 - AXIOS Stent and Electrocautery-Enhanced Delivery System K220112 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Sep 2022. https://www.510kdatabase.net/k220567/ 2022-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k220567-easi-vue-embolic-microspheres-system-fda-510k.jpg K220567 - Easi-Vue embolic microspheres System K220567 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abk Biomedical, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k220783/ 2022-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k220783-syngovia-rt-image-suite-fda-510k.jpg K220783 - syngo.via RT Image Suite K220783 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k220920/ 2022-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k220920-matreneu-percutaneous-balloon-fda-510k.jpg K220920 - Matreneu Percutaneous Balloon Compression Kit K220920 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Shineyard Medical Device Co. , Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k221731/ 2022-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k221731-fiberstitch-implant-curved-with-two-fda-510k.jpg K221731 - FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire K221731 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: T.A.G. Medical Products Corporation, Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k222034/ 2022-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k222034-rightlance-blood-lancing-system-fda-510k.jpg K222034 - RightLance Blood Lancing System K222034 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Beijing Ruicheng Medical Supplies Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k222110/ 2022-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k222110-mariner-rdx-system-fda-510k.jpg K222110 - Mariner RDX System K222110 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared Sep 2022. https://www.510kdatabase.net/k222111/ 2022-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k222111-unistik-touch-single-use-safety-fda-510k.jpg K222111 - Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G K222111 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Owen Mumford, Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k211858/ 2022-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k211858-tulsa-pro-system-fda-510k.jpg K211858 - TULSA-PRO System K211858 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Profound Medical, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k213868/ 2022-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k213868-asahi-gladius-mongo18-pv-es-fda-510k.jpg K213868 - ASAHI Gladius Mongo18 PV ES K213868 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Asahi Intecc Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k213960/ 2022-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k213960-livermultiscan-v5-lmsv5-fda-510k.jpg K213960 - LiverMultiScan v5 (LMSv5) K213960 is a FDA 510(k) cleared radiology medical device. Manufacturer: Perspectum. Cleared Sep 2022. https://www.510kdatabase.net/k220251/ 2022-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k220251-neodent-implant-system-gm-narrow-fda-510k.jpg K220251 - Neodent Implant System - GM Narrow Implant System K220251 is a FDA 510(k) cleared dental medical device. Manufacturer: Jjgc Industria E Comercio DE Materiais Dentarios S.A.. Cleared Sep 2022. https://www.510kdatabase.net/k220962/ 2022-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k220962-rotapro-rotational-atherectomy-system-fda-510k.jpg K220962 - ROTAPRO Rotational Atherectomy System K220962 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Sep 2022. https://www.510kdatabase.net/k221283/ 2022-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k221283-hammertoe-truss-system-hts-fda-510k.jpg K221283 - Hammertoe Truss System (HTS) K221283 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 4Web Medical, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k221636/ 2022-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k221636-emphasys-acetabular-system-fda-510k.jpg K221636 - EMPHASYS Acetabular System K221636 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Ireland UC. Cleared Sep 2022. https://www.510kdatabase.net/k221929/ 2022-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k221929-smithnephew-intellio-tablet-fda-510k.jpg K221929 - Smith+Nephew INTELLIO Tablet K221929 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew. Cleared Sep 2022. https://www.510kdatabase.net/k222048/ 2022-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k222048-spectrum-iq-infusion-system-with-dose-fda-510k.jpg K222048 - Spectrum IQ Infusion System with Dose IQ Safety Software K222048 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corporation. Cleared Sep 2022. https://www.510kdatabase.net/k222069/ 2022-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k222069-ez3d-ie3-fda-510k.jpg K222069 - Ez3D-i/E3 K222069 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ewoosoft Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k203503/ 2022-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k203503-camber-sacroiliac-si-fixation-system-fda-510k.jpg K203503 - Camber Sacroiliac (SI) Fixation System K203503 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Camber Spine Technologies, LLC. Cleared Sep 2022. https://www.510kdatabase.net/k211178/ 2022-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k211178-duramesh-mesh-suture-fda-510k.jpg K211178 - DURAMESH Mesh Suture K211178 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Msi. Cleared Sep 2022. https://www.510kdatabase.net/k212189/ 2022-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k212189-fibrolux-fda-510k.jpg K212189 - FibroLux K212189 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Multi Radiance Medical. Cleared Sep 2022. https://www.510kdatabase.net/k212222/ 2022-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k212222-soniquence-reusable-3-button-fda-510k.jpg K212222 - Soniquence Reusable 3 Button Fingerswitch Wand K212222 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Soniquence, LLC. Cleared Sep 2022. https://www.510kdatabase.net/k213287/ 2022-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k213287-stageone-knee-cement-spacer-molds-fda-510k.jpg K213287 - StageOne Knee Cement Spacer Molds K213287 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k213855/ 2022-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k213855-arrow-pressure-injectable-midline-fda-510k.jpg K213855 - Arrow Pressure Injectable Midline Catheter K213855 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Arrow International, LLC Subsidiary of Teleflex Incorporated. Cleared Sep 2022. https://www.510kdatabase.net/k213864/ 2022-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k213864-bonebridge-osteosynthesis-plating-system-fda-510k.jpg K213864 - Bonebridge Osteosynthesis Plating System K213864 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Bonebridge AG. Cleared Sep 2022. https://www.510kdatabase.net/k213983/ 2022-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k213983-eye-secret-59-uv-aspheric-omafilcon-a-fda-510k.jpg K213983 - Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear K213983 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Yung Sheng Optical Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k221085/ 2022-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k221085-lina-operascope-needle-fda-510k.jpg K221085 - LiNA OperaScope Needle K221085 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Lina Medical Aps. Cleared Sep 2022. https://www.510kdatabase.net/k221277/ 2022-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k221277-mygen-m-3004-rf-generator-m-3004-fda-510k.jpg K221277 - Mygen M-3004 RF Generator M-3004 K221277 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: RF Medical Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k221414/ 2022-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k221414-enroute-enflate-transcarotid-rx-fda-510k.jpg K221414 - ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter K221414 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Silk Road Medical, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k221557/ 2022-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k221557-visera-hysterovideoscope-olympus-hyf-fda-510k.jpg K221557 - Visera Hysterovideoscope Olympus HYF Type V K221557 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Olympus Medical Systems Corporation. Cleared Sep 2022. https://www.510kdatabase.net/k221644/ 2022-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k221644-synthetic-bone-putty-fda-510k.jpg K221644 - Synthetic Bone Putty K221644 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ventris Medical. Cleared Sep 2022. https://www.510kdatabase.net/k221932/ 2022-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k221932-omni-legend-fda-510k.jpg K221932 - Omni Legend K221932 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Sep 2022. https://www.510kdatabase.net/k221957/ 2022-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k221957-savewo-classicmask-fda-510k.jpg K221957 - Savewo ClassicMASK K221957 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Savewo Limited. Cleared Sep 2022. https://www.510kdatabase.net/k222075/ 2022-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k222075-cellfx-system-fda-510k.jpg K222075 - CellFX System K222075 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Pulse Biosciences, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k222426/ 2022-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k222426-perfetta-moderate-medical-face-mask-fda-510k.jpg K222426 - Perfetta Moderate Medical Face Mask K222426 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Phu Bao Group Company Limited. Cleared Sep 2022. https://www.510kdatabase.net/k201876/ 2022-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k201876-soteria-bed-barrier-fda-510k.jpg K201876 - Soteria Bed Barrier K201876 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Trinity Guardion. Cleared Sep 2022. https://www.510kdatabase.net/k220104/ 2022-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k220104-knee-fda-510k.jpg K220104 - Knee+ K220104 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Pixee Medical. Cleared Sep 2022. https://www.510kdatabase.net/k220177/ 2022-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k220177-magnus-neuromodulation-system-mns-with-fda-510k.jpg K220177 - Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K K220177 is a FDA 510(k) cleared neurology medical device. Manufacturer: Magnus Medical, Inc.. Cleared Sep 2022. https://www.510kdatabase.net/k220531/ 2022-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k220531-fox-810-fox-980-fda-510k.jpg K220531 - FOX 810, FOX 980 K220531 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: A.R.C Laser GmbH. Cleared Sep 2022. https://www.510kdatabase.net/k220563/ 2022-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k220563-ambient-hipvac-50-wand-with-integrated-fda-510k.jpg K220563 - Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System, WEREWOLF COBLATION System, WEREWOLF+ COBLATION System K220563 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: ArthroCare Corporation. Cleared Sep 2022. https://www.510kdatabase.net/k220579/ 2022-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k220579-hybrid-c70-fda-510k.jpg K220579 - Hybrid C70 K220579 is a FDA 510(k) cleared radiology medical device. Manufacturer: Digimed Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k220997/ 2022-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k220997-wireless-tensems-bruno-aela-fda-510k.jpg K220997 - Wireless TENS/EMS, Bruno, Aela K220997 is a FDA 510(k) cleared neurology medical device. Manufacturer: Zmi Elecronics , Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k221038/ 2022-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k221038-disposable-medical-masks-fda-510k.jpg K221038 - Disposable Medical Masks K221038 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hantech Medical Device Co., Ltd.. Cleared Sep 2022. https://www.510kdatabase.net/k221241/ 2022-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k221241-draid-for-radiology-v1-fda-510k.jpg K221241 - DrAid for Radiology v1 K221241 is a FDA 510(k) cleared radiology medical device. Manufacturer: Vinbrain Joint Stock Company. Cleared Sep 2022. https://www.510kdatabase.net/k221987/ 2022-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k221987-erchonia-gvl-fda-510k.jpg K221987 - Erchonia GVL K221987 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Erchonia Corporation. Cleared Sep 2022. https://www.510kdatabase.net/k210935/ 2022-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k210935-its-pelvic-reconstruction-system-prs-fda-510k.jpg K210935 - I.T.S. Pelvic Reconstruction System (PRS RX & PRS Phoenix) K210935 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: I.T.S. GmbH. Cleared Aug 2022. https://www.510kdatabase.net/k213513/ 2022-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k213513-vented-vial-adapter-20mm-fda-510k.jpg K213513 - Vented Vial Adapter 20mm K213513 is a FDA 510(k) cleared general hospital medical device. Manufacturer: West Pharma Services Il, Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k220933/ 2022-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k220933-qt-scanner-2000-model-a-fda-510k.jpg K220933 - QT Scanner 2000 Model A K220933 is a FDA 510(k) cleared radiology medical device. Manufacturer: Qt Imaging, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k221040/ 2022-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k221040-electronic-sphygmomanometers-model-x1-fda-510k.jpg K221040 - Electronic Sphygmomanometers, Model: X1, X2, X5, X6, X7,X8, X11) K221040 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Jiangxi Aicare Medical Technology Co., Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k221255/ 2022-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k221255-simplishade-bulk-fill-simplishade-bulk-fda-510k.jpg K221255 - SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow K221255 is a FDA 510(k) cleared dental medical device. Manufacturer: Kerr Corporation. Cleared Aug 2022. https://www.510kdatabase.net/k221467/ 2022-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k221467-inhancetm-reverse-glenoid-peripheral-fda-510k.jpg K221467 - INHANCETM Reverse Glenoid Peripheral Posts K221467 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Ireland UC. Cleared Aug 2022. https://www.510kdatabase.net/k221475/ 2022-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k221475-myclearalign-dental-aligner-system-fda-510k.jpg K221475 - MyClearALIGN Dental Aligner System K221475 is a FDA 510(k) cleared dental medical device. Manufacturer: Key Dental Technologies, LLC. Cleared Aug 2022. https://www.510kdatabase.net/k221507/ 2022-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k221507-disposable-blood-lancet-fda-510k.jpg K221507 - Disposable Blood Lancet K221507 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: SteriLance Medical (Suzhou), Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k221541/ 2022-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k221541-limflow-arc-fda-510k.jpg K221541 - LimFlow ARC K221541 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: LimFlow, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k221635/ 2022-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k221635-ipl-sapphire-ice-cooling-hair-remove-fda-510k.jpg K221635 - IPL sapphire ice cooling hair remove device K221635 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Desida Technology Co., Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k221745/ 2022-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k221745-sterile-posterior-spinal-fixation-system-fda-510k.jpg K221745 - Sterile Posterior Spinal Fixation System K221745 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Shanghai Reach Medical Instrument Co, Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k221955/ 2022-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k221955-brasseler-gem-brasseler-gem10-fda-510k.jpg K221955 - Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20 K221955 is a FDA 510(k) cleared radiology medical device. Manufacturer: Realcloud Imaging Inc. Dba Realcloud Imaging. Cleared Aug 2022. https://www.510kdatabase.net/k222325/ 2022-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k222325-8ch-wrist-coil-fda-510k.jpg K222325 - 8ch Wrist Coil K222325 is a FDA 510(k) cleared radiology medical device. Manufacturer: Invivo Corporation (Business Trade Name: Philips). Cleared Aug 2022. https://www.510kdatabase.net/k222387/ 2022-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k222387-vantage-galan-3t-mrt-3020-v80-with-fda-510k.jpg K222387 - Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR K222387 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Aug 2022. https://www.510kdatabase.net/k211124/ 2022-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k211124-dose-iq-safety-software-fda-510k.jpg K211124 - Dose IQ Safety Software K211124 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corporation. Cleared Aug 2022. https://www.510kdatabase.net/k211125/ 2022-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k211125-novum-iq-syringe-pump-fda-510k.jpg K211125 - Novum IQ Syringe Pump K211125 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corporation. Cleared Aug 2022. https://www.510kdatabase.net/k212846/ 2022-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k212846-sterile-hypodermic-syringe-for-single-fda-510k.jpg K212846 - Sterile Hypodermic Syringe for Single Use, with/without Needle, Sterile Hypodermic Needle for Single Use K212846 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Jichun Medical Devices Co., Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k213718/ 2022-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k213718-sol-guard-safety-pull-button-fda-510k.jpg K213718 - SOL-GUARD Safety Pull Button Collection Set K213718 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sol-Millennium Medical, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k214118/ 2022-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k214118-riva-cem-automix-fda-510k.jpg K214118 - Riva Cem Automix K214118 is a FDA 510(k) cleared dental medical device. Manufacturer: Sdi Limited. Cleared Aug 2022. https://www.510kdatabase.net/k220067/ 2022-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k220067-medical-surgery-mask-model2626-7-fda-510k.jpg K220067 - Medical Surgery Mask, Model:2626-7 K220067 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Dongguan Missadola Technology Co., Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k220280/ 2022-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k220280-arrow-stiffening-stylet-fda-510k.jpg K220280 - Arrow Stiffening Stylet K220280 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Arrow International, LLC (A subsidiary of Teleflex, Inc.). Cleared Aug 2022. https://www.510kdatabase.net/k220618/ 2022-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k220618-salipen-fda-510k.jpg K220618 - SaliPen K220618 is a FDA 510(k) cleared dental medical device. Manufacturer: Saliwell , Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k221157/ 2022-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k221157-jr-medic-fda-510k.jpg K221157 - JR Medic K221157 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jr Engineering & Medical Technologies (M) Sdn. Bhd.. Cleared Aug 2022. https://www.510kdatabase.net/k221164/ 2022-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k221164-powder-free-nitrile-examination-glove-fda-510k.jpg K221164 - Powder Free Nitrile Examination Glove - Blue, Non-Sterile, Tested for use with Chemotherapy Drugs and Fentanyl K221164 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hong Seng Gloves Sdn Bhd. Cleared Aug 2022. https://www.510kdatabase.net/k221486/ 2022-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k221486-index-bpm-fda-510k.jpg K221486 - INDEX BPM K221486 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ya Horng Electronic Co., Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k221618/ 2022-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k221618-spine-trauma-navigation-spine-fda-510k.jpg K221618 - Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine & Trauma, Alignment System Spine, Alignment Software Spine, Cirq Arm System K221618 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Brainlab AG. Cleared Aug 2022. https://www.510kdatabase.net/k221871/ 2022-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k221871-healstone-accurate-tm-drug-of-abuse-fda-510k.jpg K221871 - Healstone Accurate (TM) Drug of Abuse Urine Test Cup, Healstone Accurate (TM) Drug of Abuse Urine Test Cup Rx K221871 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Healstone Biotech, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k221970/ 2022-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k221970-lancing-device-fda-510k.jpg K221970 - Lancing device K221970 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: SteriLance Medical (Suzhou), Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k221999/ 2022-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k221999-ultrasound-transmission-gels-fda-510k.jpg K221999 - Ultrasound Transmission Gels K221999 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hony Medical Co., Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k222558/ 2022-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k222558-non-variola-orthopoxvirus-real-time-fda-510k.jpg K222558 - Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set K222558 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Centers For Disease Control and Prevention. Cleared Aug 2022. https://www.510kdatabase.net/k212248/ 2022-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k212248-glucoleader-enhance-2-blood-glucose-fda-510k.jpg K212248 - GlucoLeader Enhance 2 Blood Glucose Monitoring System K212248 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Hmd Biomedical, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k212370/ 2022-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k212370-leaderflex-mini-and-leaderflex-nano-fda-510k.jpg K212370 - Leaderflex Mini and Leaderflex Nano K212370 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Vygon USA. Cleared Aug 2022. https://www.510kdatabase.net/k220676/ 2022-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k220676-blood-pressure-monitor-fda-510k.jpg K220676 - Blood Pressure Monitor K220676 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Guangdong Transtek Medical Electronics Co., Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k220799/ 2022-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k220799-k-shield-zen-fda-510k.jpg K220799 - K-SHIELD Zen K220799 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sb-Kawasumi Laboratories, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k221100/ 2022-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k221100-viz-rvlv-fda-510k.jpg K221100 - Viz RV/LV K221100 is a FDA 510(k) cleared radiology medical device. Manufacturer: Viz. Ai, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k221111/ 2022-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k221111-non-mydriatic-retinal-camera-nw500-fda-510k.jpg K221111 - Non-Mydriatic Retinal Camera NW500 K221111 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Topcon Corporation. Cleared Aug 2022. https://www.510kdatabase.net/k221189/ 2022-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k221189-oliz-ltb-1000a-fda-510k.jpg K221189 - OLIZ LTB-1000A K221189 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Ltbio Co., Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k221785/ 2022-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k221785-tcl3-motion-tracking-system-fda-510k.jpg K221785 - TCL3 Motion Tracking System K221785 is a FDA 510(k) cleared radiology medical device. Manufacturer: Tracinnovations A/S. Cleared Aug 2022. https://www.510kdatabase.net/k222279/ 2022-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k222279-rusch-intermittent-urethral-catheters-fda-510k.jpg K222279 - Rusch Intermittent Urethral Catheters K222279 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Teleflex Medical. Cleared Aug 2022. https://www.510kdatabase.net/k222362/ 2022-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k222362-salvo-spine-system-fda-510k.jpg K222362 - Salvo® Spine System K222362 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spine Wave, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k222449/ 2022-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k222449-nitrile-powder-free-examination-gloves-fda-510k.jpg K222449 - Nitrile Powder Free Examination Gloves, Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Dark Blue) K222449 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Better Care Plastic Technology Co., Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k213802/ 2022-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k213802-stimontm-pain-relief-system-gm2439-fda-510k.jpg K213802 - StimOnTM Pain Relief System (GM2439) K213802 is a FDA 510(k) cleared neurology medical device. Manufacturer: Gimer Medical Co., Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k214058/ 2022-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k214058-beamer-aveo-electrosurgical-generator-fda-510k.jpg K214058 - Beamer AVEO Electrosurgical Generator, Beamer AVEO Argon Module, Beamer AVEO Cart, Beamer AVEO Wired Foot Pedal, Beamer AVEO Argon Pressure Reducer K214058 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Conmed Corporation. Cleared Aug 2022. https://www.510kdatabase.net/k220091/ 2022-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k220091-poly-tapeinfinity-lock-soft-tissue-fda-510k.jpg K220091 - Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device K220091 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Xiros, Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k220159/ 2022-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k220159-flexible-ureterorenoscope-model-us31d-fda-510k.jpg K220159 - Flexible Ureterorenoscope (Model: US31D-12-EU), Flexible Ureterorenoscope (Model: US31D-12-US) K220159 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Shanghai AnQing Medical Instrument Co., Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k220262/ 2022-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k220262-dimension-exl-loci-brahms-fda-510k.jpg K220262 - Dimension EXL LOCI BRAHMS Procalcitonin (PCT) K220262 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k220357/ 2022-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k220357-medcad-accushape-titanium-patient-fda-510k.jpg K220357 - MedCAD AccuShape Titanium Patient-Specific Cranial Implant K220357 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medcad. Cleared Aug 2022. https://www.510kdatabase.net/k220819/ 2022-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k220819-brainsway-deep-tms-system-fda-510k.jpg K220819 - BrainsWay Deep TMS System K220819 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainsway , Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k220875/ 2022-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k220875-hacancellous-peek-c-porous-ha-peek-fda-510k.jpg K220875 - HAcancellous PEEK-C Porous HA PEEK Cervical IBF System K220875 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Innovasis, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k221212/ 2022-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k221212-upper-arm-blood-pressure-monitor-fda-510k.jpg K221212 - Upper Arm Blood Pressure Monitor K221212 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Yolanda Technology Co., Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k221487/ 2022-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k221487-neoveil-staple-line-reinforcement-fda-510k.jpg K221487 - NEOVEIL Staple Line Reinforcement K221487 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Gunze Limited. Cleared Aug 2022. https://www.510kdatabase.net/k222256/ 2022-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k222256-bonos-inject-bone-cement-fda-510k.jpg K222256 - BonOs® Inject Bone Cement K222256 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Neo Medical SA. Cleared Aug 2022. https://www.510kdatabase.net/k222263/ 2022-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k222263-arthrex-self-punching-swivelock-suture-fda-510k.jpg K222263 - Arthrex Self Punching SwiveLock Suture Anchors K222263 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k222277/ 2022-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k222277-briefcase-fda-510k.jpg K222277 - BriefCase K222277 is a FDA 510(k) cleared radiology medical device. Manufacturer: Aidoc Medical , Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k222278/ 2022-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k222278-lospa-tkr-system-instrumentation-exult-fda-510k.jpg K222278 - LOSPA TKR System Instrumentation, EXULT TKR System Instrumentation K222278 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corentec Co., Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/den210052/ 2022-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/den210052-vibrant-system-fda-510k.jpg DEN210052 - Vibrant System DEN210052 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Vibrant, Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k211298/ 2022-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k211298-wiemspro-fda-510k.jpg K211298 - WiEMSpro K211298 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Medical Cables S.L.. Cleared Aug 2022. https://www.510kdatabase.net/k211841/ 2022-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k211841-mri-planner-fda-510k.jpg K211841 - MRI Planner K211841 is a FDA 510(k) cleared radiology medical device. Manufacturer: Spectronic Medical AB. Cleared Aug 2022. https://www.510kdatabase.net/k212140/ 2022-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k212140-glucosure-link-blood-glucose-fda-510k.jpg K212140 - GlucoSure Link Blood Glucose Monitoring System K212140 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Apex BioTechnology Corp.. Cleared Aug 2022. https://www.510kdatabase.net/k212253/ 2022-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k212253-apollo-duet-model-apd-4000-fda-510k.jpg K212253 - Apollo Duet (Model : APD-4000) K212253 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Weero Co.. Cleared Aug 2022. https://www.510kdatabase.net/k213905/ 2022-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k213905-onx-large-external-fixation-system-fda-510k.jpg K213905 - ONX Large External Fixation System K213905 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthonovis, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k220055/ 2022-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k220055-disposable-vinyl-examination-gloves-fda-510k.jpg K220055 - Disposable, vinyl examination gloves, Yellow K220055 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Dezhou Hengchang Medical Technology Co., Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k221143/ 2022-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k221143-nitrile-exam-gloves-blue-black-fda-510k.jpg K221143 - Nitrile Exam Gloves (Blue, Black) K221143 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hebei Astro Medical Supply Co., Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k221206/ 2022-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k221206-compass-steerable-needle-fda-510k.jpg K221206 - Compass Steerable Needle K221206 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Serpex Medical, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k221325/ 2022-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k221325-conduit-lateral-switch-plate-fda-510k.jpg K221325 - CONDUIT Lateral Switch Plate K221325 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International SARL. Cleared Aug 2022. https://www.510kdatabase.net/k221365/ 2022-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k221365-lapbox-tissue-containment-removal-system-fda-510k.jpg K221365 - LapBox Tissue Containment Removal System K221365 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ark Surgical, Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k221648/ 2022-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k221648-iconic-latex-glove-fda-510k.jpg K221648 - Iconic Latex Glove K221648 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Iconic Medicare Sdn Bhd. Cleared Aug 2022. https://www.510kdatabase.net/k221792/ 2022-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k221792-acute-qc-strut-and-components-fda-510k.jpg K221792 - Acute QC Strut and Components K221792 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k221962/ 2022-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k221962-linq-ii-insertable-cardiac-monitor-fda-510k.jpg K221962 - LINQ II Insertable Cardiac Monitor K221962 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k222543/ 2022-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k222543-amsco-600-steam-sterilizer-v-pro-max-2-fda-510k.jpg K222543 - AMSCO 600 Steam Sterilizer, V-PRO maX 2 Low Temperature Sterilization System, V-PRO s2 Low Temperature Sterilization System, RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP and 7053HP Single Chamber Washer Disinfector K222543 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Steris. Cleared Aug 2022. https://www.510kdatabase.net/k211771/ 2022-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k211771-the-good-high-fluid-resistant-surgical-fda-510k.jpg K211771 - The GOOD High Fluid-Resistant Surgical Mask, The GOOD High Fluid-Resistant Surgical Procedure KF Mask, The GOOD Super Guard Design High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Procedure KF Mask, The KOEASY Super Guard Design High Fluid-Resistant Surgical Mask K211771 is a FDA 510(k) cleared general hospital medical device. Manufacturer: The Good Corporation. Cleared Aug 2022. https://www.510kdatabase.net/k212784/ 2022-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k212784-tightrail-guardian-motorized-dilator-fda-510k.jpg K212784 - TightRail Guardian Motorized Dilator Sheath K212784 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Spectranetics, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k220598/ 2022-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k220598-autocontour-model-radac-v2-fda-510k.jpg K220598 - AutoContour Model RADAC V2 K220598 is a FDA 510(k) cleared radiology medical device. Manufacturer: Radformation, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k220998/ 2022-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k220998-transcutaneous-electrical-nerve-fda-510k.jpg K220998 - Transcutaneous Electrical Nerve Stimulator, Model: KTR-405 K220998 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Shenzhen Kentro Medical Electronics Co., Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k221427/ 2022-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k221427-v-laser-fda-510k.jpg K221427 - V-Laser K221427 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wontech Co., Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k221920/ 2022-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k221920-arix-small-fragment-system-fda-510k.jpg K221920 - ARIX Small Fragment System K221920 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Jeil Medical Corporation. Cleared Aug 2022. https://www.510kdatabase.net/k222212/ 2022-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k222212-ivwatch-model-400-fda-510k.jpg K222212 - ivWatch Model 400 K222212 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ivwatch, LLC. Cleared Aug 2022. https://www.510kdatabase.net/k222230/ 2022-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k222230-neurostar-neurostar-tms-therapy-system-fda-510k.jpg K222230 - NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental Health K222230 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neuronetics, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k222232/ 2022-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k222232-sherlock-3cg-tip-positioning-system-fda-510k.jpg K222232 - Sherlock 3CG® Tip Positioning System (TPS) Stylet/T-Lock Assembly K222232 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bard Access Systems, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k222236/ 2022-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k222236-micor-system-lens-fragmentation-system-fda-510k.jpg K222236 - miCOR System Lens Fragmentation System K222236 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Carl Zeiss Meditec Cataract Technology, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k213072/ 2022-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k213072-21-x-255mm-drill-22mm-stop-fda-510k.jpg K213072 - 2.1 x 255mm Drill, 22mm Stop K213072 is a FDA 510(k) cleared neurology medical device. Manufacturer: Biomet Micofixation. Cleared Aug 2022. https://www.510kdatabase.net/k213803/ 2022-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k213803-fibergraft-aeridyan-matrix-bone-graft-fda-510k.jpg K213803 - FIBERGRAFT Aeridyan Matrix Bone Graft Substitute K213803 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Prosidyan, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k220061/ 2022-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k220061-safety-insulin-syringes-fda-510k.jpg K220061 - Safety Insulin Syringes K220061 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Berpu Medical Technology Co., Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k220268/ 2022-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k220268-picosecond-laser-system-model-ps10-a-fda-510k.jpg K220268 - Picosecond Laser System (Model PS10-A and PS10-B) K220268 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Beijing Adss Development Co., Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k220583/ 2022-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k220583-clearcheck-model-radcc-v2-fda-510k.jpg K220583 - ClearCheck Model RADCC V2 K220583 is a FDA 510(k) cleared radiology medical device. Manufacturer: Radformation, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k220603/ 2022-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k220603-disposable-medical-safety-hypodermic-fda-510k.jpg K220603 - Disposable Medical Safety Hypodermic Needle K220603 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hantech Medical Device Co., Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k220640/ 2022-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k220640-bifix-hybrid-abutment-cement-fda-510k.jpg K220640 - Bifix Hybrid Abutment Cement K220640 is a FDA 510(k) cleared dental medical device. Manufacturer: Voco GmbH. Cleared Aug 2022. https://www.510kdatabase.net/k221546/ 2022-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k221546-onetouch-delica-plus-lancing-system-fda-510k.jpg K221546 - OneTouch Delica Plus Lancing System K221546 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Asahi Polyslider Co., Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k221850/ 2022-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k221850-gmk-3d-metal-tibial-tray-fda-510k.jpg K221850 - GMK 3D Metal Tibial Tray K221850 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Aug 2022. https://www.510kdatabase.net/k222257/ 2022-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k222257-15-tr-quad-extremity-coil-15t-8ch-tr-fda-510k.jpg K222257 - 1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil K222257 is a FDA 510(k) cleared radiology medical device. Manufacturer: Invivo Corporation (Business Trade Name: Philips). Cleared Aug 2022. https://www.510kdatabase.net/k222274/ 2022-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k222274-fona-xdc-fda-510k.jpg K222274 - FONA XDC K222274 is a FDA 510(k) cleared radiology medical device. Manufacturer: Fona S.R.L. Cleared Aug 2022. https://www.510kdatabase.net/k201730/ 2022-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k201730-powered-inflatable-tube-massager-slim-fda-510k.jpg K201730 - Powered Inflatable Tube Massager - SLIM UP DRAIN K201730 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Foggiare Technologies, LLC. Cleared Aug 2022. https://www.510kdatabase.net/k211601/ 2022-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k211601-powder-free-latex-examination-glove-fda-510k.jpg K211601 - Powder Free Latex Examination Glove, Non-Sterile K211601 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wrp Asia Pacific Sdn. Bhd.. Cleared Aug 2022. https://www.510kdatabase.net/k212095/ 2022-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k212095-surguard3-safety-hypodermic-needle-fda-510k.jpg K212095 - SurGuard3 Safety Hypodermic Needle K212095 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terumo Europe N.V.. Cleared Aug 2022. https://www.510kdatabase.net/k213109/ 2022-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k213109-auxilock-draw-tight-suture-based-anchor-fda-510k.jpg K213109 - Auxilock Draw Tight Suture-Based Anchor K213109 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Auxein Medical Private Limited. Cleared Aug 2022. https://www.510kdatabase.net/k220363/ 2022-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k220363-vps-rhythm-dlx-device-with-tiptracker-fda-510k.jpg K220363 - VPS Rhythm DLX Device with TipTracker Technology K220363 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Arrow International, LLC (A subsidiary of Teleflex, Inc.). Cleared Aug 2022. https://www.510kdatabase.net/k220582/ 2022-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k220582-clearcalc-model-radca-v2-fda-510k.jpg K220582 - ClearCalc Model RADCA V2 K220582 is a FDA 510(k) cleared radiology medical device. Manufacturer: Radformation, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k221485/ 2022-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k221485-arthrex-fibertape-and-tigertape-fda-510k.jpg K221485 - Arthrex FiberTape and TigerTape Cerclage Sutures K221485 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Arthrex, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k221528/ 2022-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k221528-fogarty-dilation-atrioseptostomy-fda-510k.jpg K221528 - Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter K221528 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Aug 2022. https://www.510kdatabase.net/k221599/ 2022-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k221599-hs40-diagnostic-ultrasound-system-fda-510k.jpg K221599 - HS40 Diagnostic Ultrasound System K221599 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Medison Co., Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k221604/ 2022-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k221604-safetiheel-mediheel-novaplus-fda-510k.jpg K221604 - SafetiHeel, MediHeel, Novaplus K221604 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Nsp Tech Pte, Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k221832/ 2022-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k221832-saber-014-pta-dilatation-catheter-fda-510k.jpg K221832 - SABER .014 PTA Dilatation Catheter K221832 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis US Corp. Cleared Aug 2022. https://www.510kdatabase.net/k221835/ 2022-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k221835-cusa-clarity-ultrasonic-surgical-fda-510k.jpg K221835 - CUSA Clarity Ultrasonic Surgical Aspirator System K221835 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Integra LifeSciences Corporation. Cleared Aug 2022. https://www.510kdatabase.net/k203078/ 2022-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k203078-carewe-surgical-face-mask-models-n001-fda-510k.jpg K203078 - CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW K203078 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Huizhou Tianchang Industrial Co., Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k212525/ 2022-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k212525-advcare-vial-direct-to-bag-vdb-needle-fda-510k.jpg K212525 - Advcare Vial Direct to Bag (VDB) Needle-free Admixture Devices K212525 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Advcare Medical. Cleared Aug 2022. https://www.510kdatabase.net/k212554/ 2022-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k212554-bonvadis-topical-cream-fda-510k.jpg K212554 - Bonvadis Topical Cream K212554 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stemcyte, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k213520/ 2022-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k213520-axir-cx-fda-510k.jpg K213520 - AXIR-CX K213520 is a FDA 510(k) cleared radiology medical device. Manufacturer: Radisen Co., Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k213758/ 2022-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k213758-lexa-plus-ris-311-fda-510k.jpg K213758 - Lexa PLUS RIS-311 K213758 is a FDA 510(k) cleared general hospital medical device. Manufacturer: W&H Sterilization S.R.L.. Cleared Aug 2022. https://www.510kdatabase.net/k213933/ 2022-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k213933-percent-oxygen-sensors-fda-510k.jpg K213933 - Percent Oxygen Sensors K213933 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Careox, LLC. Cleared Aug 2022. https://www.510kdatabase.net/k220016/ 2022-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k220016-viramed-borrela-all-in-one-virachip-fda-510k.jpg K220016 - Viramed Borrela All-In-One ViraChip Test Kit K220016 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Viramed Biotech AG. Cleared Aug 2022. https://www.510kdatabase.net/k220193/ 2022-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k220193-bd-max-enteric-parasite-panel-fda-510k.jpg K220193 - BD MAX Enteric Parasite Panel K220193 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson and Company. Cleared Aug 2022. https://www.510kdatabase.net/k220292/ 2022-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k220292-disposable-endoscope-injection-needle-fda-510k.jpg K220292 - Disposable Endoscope Injection Needle K220292 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Yangzhou Fartley Medical Instrument Technology Co., Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k220394/ 2022-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k220394-smartadjusttm-technology-fda-510k.jpg K220394 - SmartAdjust(TM) technology K220394 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Insulet Corporation. Cleared Aug 2022. https://www.510kdatabase.net/k220696/ 2022-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k220696-ucerv-flux-c-3d-porous-titanium-fda-510k.jpg K220696 - uCerv Flux-C 3D Porous Titanium Cervical Interbody K220696 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ulrich Medical USA. Cleared Aug 2022. https://www.510kdatabase.net/k220812/ 2022-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k220812-dynaclip-bone-staple-fda-510k.jpg K220812 - DynaClip® Bone Staple K220812 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: MedShape, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k221023/ 2022-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k221023-posterior-fusion-plateha-posterior-fda-510k.jpg K221023 - Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA Minuteman G3, HA Minuteman G3-R, Minuteman G5 K221023 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinal Simplicity, LLC. Cleared Aug 2022. https://www.510kdatabase.net/k221224/ 2022-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k221224-real-intelligence-cori-fda-510k.jpg K221224 - REAL INTELLIGENCE CORI K221224 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Blue Belt Technologies, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k221238/ 2022-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k221238-fujifilm-ultrasonic-endoscope-eg-740ut-fda-510k.jpg K221238 - FUJIFILM Ultrasonic Endoscope EG-740UT K221238 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fujifilm Corporation. Cleared Aug 2022. https://www.510kdatabase.net/k221403/ 2022-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k221403-cortera-spinal-fixation-system-fda-510k.jpg K221403 - Cortera Spinal Fixation System K221403 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Surgalign Spine Technologies. Cleared Aug 2022. https://www.510kdatabase.net/k221824/ 2022-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k221824-opclear-platform-cu3-di3-opclear-fda-510k.jpg K221824 - OpClear Platform (CU3 DI3), OpClear Control Unit with Footswitch (CS-CU33), OpClear Disposable Procedure Kits (CS-10-00-300, CS-10-30-300, CS-10-00-315, CS-10-30-315, CS-10-00-330, CS-10-30-330, CS-05-00-290, CS-05-30-290), Contd from 3 above: CS-05-00-300, CS-05-30-300, CS-05-00-315, CS-05-30-315 K221824 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cipher Surgical Limited. Cleared Aug 2022. https://www.510kdatabase.net/k221848/ 2022-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k221848-prodisc-c-sk-prodisc-c-nova-and-fda-510k.jpg K221848 - prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments K221848 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Centinel Spine, LLC. Cleared Aug 2022. https://www.510kdatabase.net/k221917/ 2022-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k221917-stent-positioning-assistance-system-spas-fda-510k.jpg K221917 - Stent Positioning Assistance System (SPAS) K221917 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Seven Sons , Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k222130/ 2022-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k222130-1688-4k-camera-system-with-advanced-fda-510k.jpg K222130 - 1688 4K Camera System with Advanced Imaging Modality K222130 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker. Cleared Aug 2022. https://www.510kdatabase.net/k222172/ 2022-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k222172-mi-viewgo-fda-510k.jpg K222172 - MI View&GO K222172 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k222194/ 2022-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k222194-baby-gorillagorilla-plating-system-fda-510k.jpg K222194 - Baby Gorilla®/Gorilla® Plating System K222194 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paragon 28, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k222239/ 2022-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k222239-smartbolus-calculator-fda-510k.jpg K222239 - SmartBolus Calculator K222239 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Insulet Corporation. Cleared Aug 2022. https://www.510kdatabase.net/k210797/ 2022-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k210797-bio-mem-ti-reinforced-membrane-fda-510k.jpg K210797 - Bio-MEM Ti Reinforced Membrane K210797 is a FDA 510(k) cleared dental medical device. Manufacturer: B&Medi Co., Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k212518/ 2022-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k212518-jeesung-safety-syringe-and-single-use-fda-510k.jpg K212518 - Jeesung Safety Syringe and Single Use Needles K212518 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jeesung Medical Co., Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k212856/ 2022-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k212856-iclean-viral-transport-system-vtm-rt-kit-fda-510k.jpg K212856 - iClean Viral Transport System (VTM-RT kit) K212856 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Huachenyang (Shenzhen) Technology Co. , Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k212905/ 2022-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k212905-sotair-device-fda-510k.jpg K212905 - Sotair Device K212905 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Safe Bvm Corporation. Cleared Aug 2022. https://www.510kdatabase.net/k213390/ 2022-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k213390-benchmark-bmx96-access-system-fda-510k.jpg K213390 - Benchmark BMX96 Access System K213390 is a FDA 510(k) cleared neurology medical device. Manufacturer: Penumbra, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k220647/ 2022-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k220647-guideliner-coast-55f-5270-fda-510k.jpg K220647 - GuideLiner Coast, 5.5F (5270) K220647 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vascular Solutions, LLC. Cleared Aug 2022. https://www.510kdatabase.net/k220959/ 2022-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k220959-or3o-dual-mobility-system-fda-510k.jpg K220959 - OR3O Dual Mobility System K220959 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k221213/ 2022-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k221213-ensite-x-ep-system-fda-510k.jpg K221213 - EnSite X EP System K221213 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott. Cleared Aug 2022. https://www.510kdatabase.net/k221353/ 2022-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k221353-quantum-perfusion-dual-lumen-cannula-fda-510k.jpg K221353 - Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F, Quantum Perfusion Dual Lumen Cannula 29F, Quantum Perfusion Dual Lumen Cannula 24F-V1, Quantum Perfusion Dual Lumen Cannula 27F-V1, Quantum Perfusion Dual Lumen Cannula 29F-V1, Quantum Perfusion Dual Lumen Cannula 27F-VS, Quantum Perfusion Dual Lumen Cannula 31F-VS K221353 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Qura S.R.L. Cleared Aug 2022. https://www.510kdatabase.net/k221520/ 2022-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k221520-miro3d-wound-matrix-fda-510k.jpg K221520 - Miro3D Wound Matrix K221520 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Reprise Biomedical, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k222272/ 2022-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k222272-trufreeze-console-pn-cc301-fda-510k.jpg K222272 - truFreeze Console, PN CC301 K222272 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: STERIS Corporation. Cleared Aug 2022. https://www.510kdatabase.net/k210678/ 2022-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k210678-implafit-hip-stems-fda-510k.jpg K210678 - implaFit® hip stems K210678 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Implantcast GmbH. Cleared Aug 2022. https://www.510kdatabase.net/k212033/ 2022-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k212033-disposable-sterile-syringe-withwithout-fda-510k.jpg K212033 - Disposable Sterile Syringe, with/without needle K212033 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shandong Zhushi Pharmaceutical Group Co., Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k212273/ 2022-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k212273-cross-protection-resq300-plus-surgical-fda-510k.jpg K212273 - Cross Protection ResQ300 Plus Surgical Face Mask K212273 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cross Protection (M) Sdn Bhd. Cleared Aug 2022. https://www.510kdatabase.net/k220387/ 2022-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k220387-disposable-blood-lancets-fda-510k.jpg K220387 - Disposable Blood Lancets K220387 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Suzhou Kyuan Medical Apparatus Co., Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k220452/ 2022-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k220452-materialise-shoulder-systemtm-fda-510k.jpg K220452 - Materialise Shoulder SystemTM Materialise Shoulder Guide and Models SurgiCase Shoulder Planner K220452 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Materialise NV. Cleared Aug 2022. https://www.510kdatabase.net/k220530/ 2022-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k220530-tetragraph-neuromuscular-transmission-fda-510k.jpg K220530 - Tetragraph Neuromuscular Transmission Monitor K220530 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Senzime AB. Cleared Aug 2022. https://www.510kdatabase.net/k220897/ 2022-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k220897-disposable-brain-biopsy-needle-20-fda-510k.jpg K220897 - Disposable Brain Biopsy Needle 2.0 K220897 is a FDA 510(k) cleared neurology medical device. Manufacturer: PAJUNK GmbH Medizintechnologie. Cleared Aug 2022. https://www.510kdatabase.net/k220903/ 2022-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k220903-webceph-fda-510k.jpg K220903 - WebCeph K220903 is a FDA 510(k) cleared radiology medical device. Manufacturer: Assemblecircle Corp.. Cleared Aug 2022. https://www.510kdatabase.net/k221112/ 2022-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k221112-carto-3-ep-navigation-system-with-fda-510k.jpg K221112 - CARTO 3 EP Navigation System with Advanced Focus Mapping (AFM) K221112 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biosense Webster, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k221838/ 2022-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k221838-surgical-face-mask-hnfm0103-fda-510k.jpg K221838 - Surgical Face Mask (HNFM0103) K221838 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shanghai Hua EN Industrial Co, Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k221844/ 2022-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k221844-tdm-lumbar-interbody-fusion-cage-system-fda-510k.jpg K221844 - TDM Lumbar Interbody Fusion Cage System K221844 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tdm Co., Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k212385/ 2022-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k212385-yuwell-finger-pulse-oximeter-fda-510k.jpg K212385 - YUWELL Finger Pulse Oximeter K212385 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Jiangsu Yuyue Medical Equipment& Supply Co., Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k213026/ 2022-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k213026-clear-aligner-fda-510k.jpg K213026 - Clear Aligner K213026 is a FDA 510(k) cleared dental medical device. Manufacturer: Shenzhen Meiming Dentistry Technology Co., Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k213426/ 2022-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k213426-hemosil-readiplastin-fda-510k.jpg K213426 - HemosIL ReadiPlasTin K213426 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Aug 2022. https://www.510kdatabase.net/k213937/ 2022-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k213937-halyard-lavender-nitrile-low-fda-510k.jpg K213937 - Halyard Lavender Nitrile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid Fluid/Fentanyl Citrate Injection Mix 50/50 Solution K213937 is a FDA 510(k) cleared general hospital medical device. Manufacturer: O&M Halyard, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k220329/ 2022-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k220329-g-cam-fda-510k.jpg K220329 - G-CAM K220329 is a FDA 510(k) cleared dental medical device. Manufacturer: Graphenano Dental S.L.. Cleared Aug 2022. https://www.510kdatabase.net/k220433/ 2022-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k220433-syngo-application-software-ve21-fda-510k.jpg K220433 - syngo Application Software (VE21) K220433 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solution USA, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k221190/ 2022-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k221190-acuson-juniper-diagnostic-ultrasound-fda-510k.jpg K221190 - ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic Ultrasound System K221190 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k221852/ 2022-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k221852-shockwave-intravascular-lithotripsy-fda-510k.jpg K221852 - Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL Catheter K221852 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shockwave Medical, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k222169/ 2022-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k222169-fairfix-adjustable-button-system-fda-510k.jpg K222169 - FairFix Adjustable Button System K222169 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Aug 2022. https://www.510kdatabase.net/k212790/ 2022-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k212790-xlase-plus-fda-510k.jpg K212790 - XLase Plus K212790 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Biotec Italia, Srl. Cleared Aug 2022. https://www.510kdatabase.net/k213527/ 2022-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k213527-forum-fda-510k.jpg K213527 - FORUM K213527 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Carl Zeiss Meditec, AG. Cleared Aug 2022. https://www.510kdatabase.net/k213845/ 2022-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k213845-hero-graft-fda-510k.jpg K213845 - HeRO Graft K213845 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k214095/ 2022-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k214095-da-vinci-xxi-is4200is4000-8mm-reusable-fda-510k.jpg K214095 - da Vinci X/Xi (IS4200/IS4000) 8mm Reusable Instruments K214095 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k220163/ 2022-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k220163-her-2-er-pr-ihcontrols-fda-510k.jpg K220163 - Her-2, ER, PR IHControls K220163 is a FDA 510(k) cleared pathology medical device. Manufacturer: Boston Cell Standards, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k221302/ 2022-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k221302-recon-steerable-sheath-fda-510k.jpg K221302 - Recon Steerable Sheath K221302 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Serpex Medical, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k202461/ 2022-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k202461-thermacor-1200-disposable-sets-for-the-fda-510k.jpg K202461 - ThermaCor 1200 Disposable Sets for the ThermaCor 1200 Rapid Thermal Infusion System K202461 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Smisson-Cartledge Biomedical, LLC. Cleared Aug 2022. https://www.510kdatabase.net/k202508/ 2022-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k202508-hemo-lyte-c-cartridge-fda-510k.jpg K202508 - Hemo-Lyte C Cartridge K202508 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Di-Chem, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k202739/ 2022-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k202739-bioland-g-425-2v-blood-glucose-fda-510k.jpg K202739 - Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System K202739 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bioland Technology, Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k213686/ 2022-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k213686-skout-software-fda-510k.jpg K213686 - SKOUT Software K213686 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Iterative Scopes, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k220090/ 2022-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k220090-visibly-digital-acuity-product-fda-510k.jpg K220090 - Visibly Digital Acuity Product K220090 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Visibly, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k220349/ 2022-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k220349-terarecon-neuro-fda-510k.jpg K220349 - TeraRecon Neuro K220349 is a FDA 510(k) cleared radiology medical device. Manufacturer: Terarecon,Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k220385/ 2022-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k220385-intense-pulsed-light-equipment-fda-510k.jpg K220385 - Intense Pulsed Light Equipment K220385 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Beijing Globalipl Development Co., Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k220403/ 2022-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k220403-vibe-sf-self-fitting-hearing-aid-fda-510k.jpg K220403 - Vibe SF Self-Fitting Hearing Aid K220403 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Wsaud A/S. Cleared Aug 2022. https://www.510kdatabase.net/k220434/ 2022-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k220434-blue-eye-ts-905-fda-510k.jpg K220434 - Blue Eye (TS-905) K220434 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: The Standard Co., Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k220680/ 2022-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k220680-denture-base-polymers-fda-510k.jpg K220680 - Denture Base Polymers K220680 is a FDA 510(k) cleared dental medical device. Manufacturer: Shandong Huge Dental Material Corporation. Cleared Aug 2022. https://www.510kdatabase.net/k220835/ 2022-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k220835-arkligners-fda-510k.jpg K220835 - Arkligners K220835 is a FDA 510(k) cleared dental medical device. Manufacturer: Arklign Laboratories. Cleared Aug 2022. https://www.510kdatabase.net/k221027/ 2022-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k221027-isolation-gown-s-m-l-xl-xxl-yellow-blue-fda-510k.jpg K221027 - Isolation Gown (S, M, L, XL, XXL (Yellow, Blue)) K221027 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Allmed Medical (Hubei) Protective Products Co., Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k221049/ 2022-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k221049-zavation-varisync-plate-system-and-fda-510k.jpg K221049 - Zavation VariSync Plate System and VariSync Spacer System K221049 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zavation Medical Products, LLC. Cleared Aug 2022. https://www.510kdatabase.net/k221126/ 2022-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k221126-unistik-3-sterile-single-use-safety-fda-510k.jpg K221126 - Unistik® 3, sterile single-use safety lancets K221126 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Owen Mumford, Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k221131/ 2022-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k221131-tasso-fda-510k.jpg K221131 - Tasso+ K221131 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Tasso, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k221466/ 2022-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k221466-ipl-hair-removal-device-model-ai01-fda-510k.jpg K221466 - IPL Hair Removal Device, model: AI01, AI06, AI08, AI16, AI17 K221466 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Century Dongyuan Technology CO , Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k222082/ 2022-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k222082-aprevo-anterior-and-lateral-lumbar-fda-510k.jpg K222082 - aprevo® anterior and lateral lumbar interbody fusion devices, aprevo® transforaminal lumbar interbody fusion devices K222082 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Carlsmed, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k222145/ 2022-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k222145-ezdent-i-e2-prora-view-smart-m-viewer-fda-510k.jpg K222145 - EzDent-i / E2 / Prora View/ Smart M Viewer K222145 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ewoosoft Co., Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k210949/ 2022-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k210949-foundation-dermal-regeneration-fda-510k.jpg K210949 - Foundation Dermal Regeneration Scaffold (DRS) Solo K210949 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bionova Medical, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k212361/ 2022-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k212361-novo-fda-510k.jpg K212361 - Novo K212361 is a FDA 510(k) cleared pathology medical device. Manufacturer: PathAI, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k213713/ 2022-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k213713-ai-rad-companion-pulmonary-fda-510k.jpg K213713 - AI-Rad Companion (Pulmonary) K213713 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Healthcare GmbH. Cleared Aug 2022. https://www.510kdatabase.net/k220050/ 2022-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k220050-kls-martin-ips-distraction-fda-510k.jpg K220050 - KLS Martin IPS Distraction K220050 is a FDA 510(k) cleared dental medical device. Manufacturer: KLS-Martin L.P.. Cleared Aug 2022. https://www.510kdatabase.net/k220308/ 2022-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k220308-patient-monitor-resparray-fda-510k.jpg K220308 - Patient Monitor: RespArray K220308 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edan Instruments, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k220472/ 2022-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k220472-neuwave-microwave-ablation-system-and-fda-510k.jpg K220472 - NEUWAVE Microwave Ablation System and Accessories K220472 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Neuwave Medical, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k220648/ 2022-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k220648-omf-asp-system-fda-510k.jpg K220648 - OMF ASP System K220648 is a FDA 510(k) cleared dental medical device. Manufacturer: Vha Dean. Cleared Aug 2022. https://www.510kdatabase.net/k220731/ 2022-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k220731-insignia-hip-stem-restoration-modular-fda-510k.jpg K220731 - Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem K220731 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker. Cleared Aug 2022. https://www.510kdatabase.net/k220910/ 2022-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k220910-medical-image-processing-software-fda-510k.jpg K220910 - Medical image processing software K220910 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hangzhou Deepwise & League of PHD Technology Co., Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k221177/ 2022-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k221177-erbes-tubingcap-sets-fda-510k.jpg K221177 - Erbe's Tubing/Cap Sets K221177 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Erbe USA, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k221385/ 2022-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k221385-liftup-ref-nr-2005601-liftup-kit-ref-fda-510k.jpg K221385 - LiftUp (Ref. Nr.: 200.56.01), LiftUp Kit (Ref. Nr.: 200.56.02) K221385 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ovesco Endoscopy AG. Cleared Aug 2022. https://www.510kdatabase.net/k221737/ 2022-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k221737-instafill-graft-delivery-system-fda-510k.jpg K221737 - InstaFill Graft Delivery System, SIGNIFY Bioactive K221737 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Globus Medical, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k222161/ 2022-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k222161-arthrex-knotless-fibertak-biceps-fda-510k.jpg K222161 - Arthrex Knotless FiberTak Biceps Suture Anchor K222161 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k222414/ 2022-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k222414-tera-harz-denture-fda-510k.jpg K222414 - TERA HARZ DENTURE K222414 is a FDA 510(k) cleared dental medical device. Manufacturer: Graphy, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k212364/ 2022-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k212364-blt-dental-implant-system-fda-510k.jpg K212364 - BLT Dental Implant System K212364 is a FDA 510(k) cleared dental medical device. Manufacturer: Bio Concept Co., Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k212763/ 2022-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k212763-univit-he-univit-uhs-fda-510k.jpg K212763 - UniVit HE, UniVit UHS K212763 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Visioncare Devices, LLC. Cleared Aug 2022. https://www.510kdatabase.net/k213524/ 2022-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k213524-cytonpro-5000-fda-510k.jpg K213524 - CytonPro-5000 K213524 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Cytonsys, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k220056/ 2022-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k220056-isyncwave-fda-510k.jpg K220056 - iSyncWave K220056 is a FDA 510(k) cleared neurology medical device. Manufacturer: iMediSync, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k220900/ 2022-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k220900-safety-blood-collection-needles-fda-510k.jpg K220900 - Safety Blood Collection Needles with/without Needle Holder K220900 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k221381/ 2022-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k221381-kdg-abutments-fda-510k.jpg K221381 - KDG Abutments K221381 is a FDA 510(k) cleared dental medical device. Manufacturer: Keystone Dental, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k221879/ 2022-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k221879-patient-monitor-models-lm-8-lm-10-lm-fda-510k.jpg K221879 - Patient Monitor, models LM-8, LM-10, LM-12 and LM-15 K221879 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Caf Medical Solutions, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k212482/ 2022-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k212482-non-sterile-powder-free-latex-fda-510k.jpg K212482 - Non-sterile, Powder-Free Latex Examination Glove Ocean Blue, Violet Blue, Black and Natural White K212482 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sri Trang Gloves (Thailand) Public Company Limited. Cleared Aug 2022. https://www.510kdatabase.net/k213609/ 2022-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k213609-nova-resin-dual-cure-self-adhesive-fda-510k.jpg K213609 - NOVA RESIN dual cure, self adhesive resin cement K213609 is a FDA 510(k) cleared dental medical device. Manufacturer: Imicryl Dis Malzemeleri Sanayi VE Ticaret AS. Cleared Aug 2022. https://www.510kdatabase.net/k220077/ 2022-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k220077-imicryl-composite-composite-flow-fda-510k.jpg K220077 - IMICRYL Composite, Composite Flow Materials K220077 is a FDA 510(k) cleared dental medical device. Manufacturer: Imicryl Dis Malzemeleri Sanayi VE Ticaret AS. Cleared Aug 2022. https://www.510kdatabase.net/k220241/ 2022-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k220241-point-kinguide-robotic-assisted-fda-510k.jpg K220241 - “POINT” Kinguide Robotic-Assisted Surgical System K220241 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Point Robotics MedTech, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k221776/ 2022-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k221776-nextgen-pedicle-screw-system-fda-510k.jpg K221776 - NextGen Pedicle Screw System K221776 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corelink, LLC. Cleared Aug 2022. https://www.510kdatabase.net/k221789/ 2022-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k221789-iris-pi-q-switched-nd-yag-laser-fda-510k.jpg K221789 - IRIS Pi Q switched Nd YAG laser K221789 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bio-Med USA, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k222083/ 2022-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k222083-limflow-v-ceiver-fda-510k.jpg K222083 - LimFlow V-Ceiver K222083 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: LimFlow, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k222357/ 2022-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k222357-denmat-glutaraldehyde-desensitizer-fda-510k.jpg K222357 - DenMat Glutaraldehyde Desensitizer K222357 is a FDA 510(k) cleared dental medical device. Manufacturer: Denmat Holding, LLC. Cleared Aug 2022. https://www.510kdatabase.net/k211675/ 2022-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k211675-dasky-disposable-sampling-tube-model-fda-510k.jpg K211675 - Dasky Disposable Sampling Tube (Model name: VSM02) K211675 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Ningbo Dasky Life Science Co., Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k212243/ 2022-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k212243-vitek-2-ast-gram-positive-telavancin-fda-510k.jpg K212243 - VITEK 2 AST- Gram Positive Telavancin (<=0.015 - >=1 µg/mL) K212243 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k213645/ 2022-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k213645-clearpoint-maestro-brain-model-fda-510k.jpg K213645 - ClearPoint Maestro Brain Model K213645 is a FDA 510(k) cleared radiology medical device. Manufacturer: ClearPoint Neuro, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k213727/ 2022-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k213727-ds-sentinelle-breast-16ch-30t-coil-fda-510k.jpg K213727 - dS Sentinelle Breast 16ch 3.0T Coil K213727 is a FDA 510(k) cleared radiology medical device. Manufacturer: Invivo Corporation (Business Trade Name: Philips). Cleared Aug 2022. https://www.510kdatabase.net/k213735/ 2022-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k213735-ds-sentinelle-breast-16ch-15t-coil-fda-510k.jpg K213735 - dS Sentinelle Breast 16ch 1.5T Coil K213735 is a FDA 510(k) cleared radiology medical device. Manufacturer: Invivo Corporation (Business Trade Name: Philips). Cleared Aug 2022. https://www.510kdatabase.net/k221668/ 2022-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k221668-dental-impression-material-fda-510k.jpg K221668 - Dental Impression Material K221668 is a FDA 510(k) cleared dental medical device. Manufacturer: Chemoment Materials Co.,Ltd. Cleared Aug 2022. https://www.510kdatabase.net/k222072/ 2022-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k222072-dolphin-imaging-120-fda-510k.jpg K222072 - Dolphin Imaging 12.0 K222072 is a FDA 510(k) cleared radiology medical device. Manufacturer: Patterson Dental Supply, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k213934/ 2022-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k213934-pro-guard-nitrile-powder-free-fda-510k.jpg K213934 - Pro Guard Nitrile Powder Free Examination Glove K213934 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medical Glove Co., Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k221854/ 2022-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k221854-reprocesses-umbilical-cable-fda-510k.jpg K221854 - Reprocesses Umbilical Cable K221854 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Innovative Health, LLC. Cleared Aug 2022. https://www.510kdatabase.net/k212810/ 2022-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k212810-monofix-pgcl-knotless-wound-closure-fda-510k.jpg K212810 - MONOFIX PGCL, knotless wound closure device K212810 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Samyang Holdings Corp., Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k213791/ 2022-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k213791-unispace-sa-cervical-cage-fda-510k.jpg K213791 - Unispace SA Cervical Cage K213791 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Edisoninno Co., Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k213876/ 2022-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k213876-spineology-navigation-instruments-fda-510k.jpg K213876 - Spineology Navigation Instruments K213876 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spineology, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k213993/ 2022-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k213993-powder-free-chloroprene-examination-fda-510k.jpg K213993 - Powder Free Chloroprene Examination Glove Coloured (Blue, Green) K213993 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Careglove Global Sdn. Bhd.. Cleared Aug 2022. https://www.510kdatabase.net/k220045/ 2022-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k220045-trevues-polymacon-soft-hydrophilic-fda-510k.jpg K220045 - TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) K220045 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Dk Medivision Co., Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k220576/ 2022-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k220576-fama-male-latex-condoms-fda-510k.jpg K220576 - FAMA Male Latex Condoms K220576 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shanghai Personage Hygiene Products Co., Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k221336/ 2022-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k221336-avli-fda-510k.jpg K221336 - Avéli K221336 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Revelle Aesthetics, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k221350/ 2022-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k221350-non-sterile-powder-free-nitrile-fda-510k.jpg K221350 - Non-Sterile Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) K221350 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Rubberex Alliance Products Sdn Bhd. Cleared Aug 2022. https://www.510kdatabase.net/k221405/ 2022-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k221405-neurophet-scale-pet-fda-510k.jpg K221405 - Neurophet SCALE PET K221405 is a FDA 510(k) cleared radiology medical device. Manufacturer: Neurophet., Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k211614/ 2022-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k211614-centermed-patient-matched-assisted-fda-510k.jpg K211614 - CenterMed Patient Matched Assisted Surgical Planning (ASP) System K211614 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Centermed, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k220001/ 2022-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k220001-diazyme-human-kappa-free-light-chain-fda-510k.jpg K220001 - Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain Assay K220001 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diazyme Laboratories, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k220303/ 2022-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k220303-mdhearingaid-app-mdhearingaid-smart-fda-510k.jpg K220303 - MDHearingAid app, MDHearingAid Smart hearing aids K220303 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Mdhearingaid. Cleared Aug 2022. https://www.510kdatabase.net/k220524/ 2022-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k220524-well-life-mini-tens-stimulatorwl-fda-510k.jpg K220524 - Well-Life Mini TENS Stimulator(WL-23XXC/WL-23XXE Series) K220524 is a FDA 510(k) cleared neurology medical device. Manufacturer: Well-Life Healthcare Limited. Cleared Aug 2022. https://www.510kdatabase.net/k220887/ 2022-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k220887-mini-clottriever-thrombectomy-system-fda-510k.jpg K220887 - Mini-ClotTriever Thrombectomy System K220887 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inari Medical. Cleared Aug 2022. https://www.510kdatabase.net/k221104/ 2022-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k221104-actera-hip-system-fda-510k.jpg K221104 - Actera™ hip system K221104 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Conformis, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k221124/ 2022-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k221124-mantis-clip-fda-510k.jpg K221124 - MANTIS Clip K221124 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Aug 2022. https://www.510kdatabase.net/k221328/ 2022-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k221328-bloomi-smooth-water-based-lubricant-fda-510k.jpg K221328 - Bloomi Smooth Water Based Lubricant K221328 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: The Bloomi Inc... Cleared Aug 2022. https://www.510kdatabase.net/k221628/ 2022-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k221628-exgraft-exgraft-carbon-fda-510k.jpg K221628 - exGraft, exGraft Carbon K221628 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Peca Labs. Cleared Aug 2022. https://www.510kdatabase.net/k221952/ 2022-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k221952-endoscope-model-eg-580ut-and-endoscope-fda-510k.jpg K221952 - Endoscope Model EG-580UT and Endoscope Model EG-580UR K221952 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fujifilm Corporation. Cleared Aug 2022. https://www.510kdatabase.net/k221953/ 2022-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k221953-masimo-carescape-spo2-masimo-with-sphb-fda-510k.jpg K221953 - Masimo CARESCAPE SpO2 – Masimo with SpHb K221953 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Masimo Corporation. Cleared Aug 2022. https://www.510kdatabase.net/k191131/ 2022-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k191131-solidence-multipockets-fda-510k.jpg K191131 - Solidence Multipockets K191131 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Solidence Surgical Corporation. Cleared Aug 2022. https://www.510kdatabase.net/k212181/ 2022-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k212181-immunocap-allergen-f433-allergen-fda-510k.jpg K212181 - ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed K212181 is a FDA 510(k) cleared immunology medical device. Manufacturer: Phadia AB. Cleared Aug 2022. https://www.510kdatabase.net/k213477/ 2022-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k213477-root-zx3-fda-510k.jpg K213477 - Root ZX3 K213477 is a FDA 510(k) cleared dental medical device. Manufacturer: J. Morita USA, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k213614/ 2022-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k213614-cannulated-screws-fda-510k.jpg K213614 - Cannulated Screws K213614 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Maxxion Medical, LLC. Cleared Aug 2022. https://www.510kdatabase.net/k220139/ 2022-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k220139-qscreen-fda-510k.jpg K220139 - QScreen K220139 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Path Medical GmbH. Cleared Aug 2022. https://www.510kdatabase.net/k221347/ 2022-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k221347-transpara-172-fda-510k.jpg K221347 - Transpara 1.7.2 K221347 is a FDA 510(k) cleared radiology medical device. Manufacturer: Screenpoint Medical B.V.. Cleared Aug 2022. https://www.510kdatabase.net/k221432/ 2022-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k221432-customize-fda-510k.jpg K221432 - Customize K221432 is a FDA 510(k) cleared radiology medical device. Manufacturer: 3D-Side S.A.. Cleared Aug 2022. https://www.510kdatabase.net/k210179/ 2022-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k210179-qoca-portable-ecg-monitoring-device-fda-510k.jpg K210179 - QOCA Portable ECG Monitoring Device K210179 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quanta Computer, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k220032/ 2022-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k220032-istent-infinite-trabecular-micro-fda-510k.jpg K220032 - iStent infinite Trabecular Micro-Bypass System, Model iS3 K220032 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Glaukos Corporation. Cleared Aug 2022. https://www.510kdatabase.net/k220816/ 2022-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k220816-bruxzir-now-fda-510k.jpg K220816 - BruxZir NOW K220816 is a FDA 510(k) cleared dental medical device. Manufacturer: Prismatik Dentalcraft, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k213929/ 2022-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k213929-halyard-purple-nitrile-powder-free-fda-510k.jpg K213929 - Halyard Purple Nitrile, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid K213929 is a FDA 510(k) cleared general hospital medical device. Manufacturer: O&M Halyard, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k220237/ 2022-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k220237-disposable-medical-nitrile-examination-fda-510k.jpg K220237 - Disposable Medical Nitrile Examination Gloves K220237 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Fujian Jixiang Medical Technology Co.,Ltd. Cleared Aug 2022. https://www.510kdatabase.net/k220736/ 2022-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k220736-consolidated-hc-steam-sterilizer-fda-510k.jpg K220736 - Consolidated HC Steam Sterilizer K220736 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Consolidated Machine Corp.. Cleared Aug 2022. https://www.510kdatabase.net/k221451/ 2022-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k221451-ipl-hair-removal-fda-510k.jpg K221451 - IPL hair removal K221451 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Lizbella Technology Co.,Ltd. Cleared Aug 2022. https://www.510kdatabase.net/k221549/ 2022-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k221549-x-ray-flat-panel-detectors-careview-fda-510k.jpg K221549 - X-ray Flat Panel Detectors (CareView 1800 RF) K221549 is a FDA 510(k) cleared radiology medical device. Manufacturer: Careray Digital Medical Technology Co., Ltd.. Cleared Aug 2022. https://www.510kdatabase.net/k221616/ 2022-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k221616-patient-monitor-models-lmplus-12-fda-510k.jpg K221616 - Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17 K221616 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Caf Medical Solutions, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k221671/ 2022-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k221671-cellfx-system-fda-510k.jpg K221671 - CellFX® System K221671 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Pulse Biosciences, Inc.. Cleared Aug 2022. https://www.510kdatabase.net/k221773/ 2022-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k221773-blue-nitrile-powder-free-patient-fda-510k.jpg K221773 - Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With the Opioid Fentanyl Citrate, Simulated Gastric Acid, and Fentanyl In Gastric Acid K221773 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Onetexx Sdn Bhd. Cleared Jul 2022. https://www.510kdatabase.net/k202852/ 2022-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k202852-divitum-tka-fda-510k.jpg K202852 - DiviTum TKa K202852 is a FDA 510(k) cleared immunology medical device. Manufacturer: Biovica International AB. Cleared Jul 2022. https://www.510kdatabase.net/k211370/ 2022-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k211370-tablo-hemodialysis-system-fda-510k.jpg K211370 - Tablo Hemodialysis System K211370 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Outset Medical, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k211585/ 2022-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k211585-bodyport-cardiac-scale-fda-510k.jpg K211585 - Bodyport Cardiac Scale K211585 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bodyport, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k212982/ 2022-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k212982-medispine-spinal-needle-glospine-fda-510k.jpg K212982 - Medispine - Spinal Needle, Glospine - Spinal Needle K212982 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Global Medikit Limited. Cleared Jul 2022. https://www.510kdatabase.net/k213104/ 2022-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k213104-auxilock-titanium-screw-in-suture-anchor-fda-510k.jpg K213104 - Auxilock Titanium Screw-In Suture Anchor K213104 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Auxein Medical Private Limited. Cleared Jul 2022. https://www.510kdatabase.net/k213760/ 2022-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k213760-abmd-software-fda-510k.jpg K213760 - ABMD Software K213760 is a FDA 510(k) cleared radiology medical device. Manufacturer: HeartLung Corporation. Cleared Jul 2022. https://www.510kdatabase.net/k213911/ 2022-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k213911-microstream-co2-nanopod-fda-510k.jpg K213911 - Microstream CO2 NanoPod K213911 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Covidien, LLC. Cleared Jul 2022. https://www.510kdatabase.net/k213914/ 2022-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k213914-injection-needle-fda-510k.jpg K213914 - Injection Needle K213914 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Jiangsu Vedkang Medical Science and Technology Co., Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k220048/ 2022-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k220048-nobelprocera-zirconia-n1-base-fda-510k.jpg K220048 - NobelProcera Zirconia N1 Base K220048 is a FDA 510(k) cleared dental medical device. Manufacturer: Nobel Biocare Services AG. Cleared Jul 2022. https://www.510kdatabase.net/k220331/ 2022-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k220331-091-balloon-guide-catheter-fda-510k.jpg K220331 - 091 Balloon Guide Catheter K220331 is a FDA 510(k) cleared neurology medical device. Manufacturer: Inneuroco, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k220566/ 2022-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k220566-vascette-hp-hemostatic-pad-fda-510k.jpg K220566 - Vascette HP (hemostatic pad) K220566 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Koag, LLC. Cleared Jul 2022. https://www.510kdatabase.net/k220577/ 2022-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k220577-dental-handpiece-model-ca160-ca160l-fda-510k.jpg K220577 - Dental Handpiece, Model CA160, CA160L, and CA500L K220577 is a FDA 510(k) cleared dental medical device. Manufacturer: Micro-Nx Co., Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k220733/ 2022-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k220733-optivu-rosa-mxr-fda-510k.jpg K220733 - OptiVu ROSA MxR K220733 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthosoft Inc. (d/b/a) Zimmer CAS. Cleared Jul 2022. https://www.510kdatabase.net/k220901/ 2022-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k220901-s-core-implant-system-fda-510k.jpg K220901 - S-Core Implant System K220901 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Subchondral Solutions, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k220961/ 2022-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k220961-deep-learning-image-reconstruction-fda-510k.jpg K220961 - Deep Learning Image Reconstruction K220961 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare Japan Corporation. Cleared Jul 2022. https://www.510kdatabase.net/k220989/ 2022-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k220989-next-generation-netkonnect-fda-510k.jpg K220989 - Next Generation NetKonnect K220989 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden Digital Health Solutions, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k221242/ 2022-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k221242-vsmilehappyzir-dental-zirconia-blank-fda-510k.jpg K221242 - Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank K221242 is a FDA 510(k) cleared dental medical device. Manufacturer: Hunan Vsmile Biotechnology Co., Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k221251/ 2022-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k221251-ems-foot-stimulator-model-hk701-hk701a-fda-510k.jpg K221251 - Ems Foot Stimulator (model: HK701, HK701A, HK701B, HK701C) K221251 is a FDA 510(k) cleared neurology medical device. Manufacturer: Guangzhou Huakai Electronic Technology Co., Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k221259/ 2022-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k221259-dexcom-g6-continuous-glucose-fda-510k.jpg K221259 - Dexcom G6 Continuous Glucose Monitoring (CGM) System, Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System, Dexcom G6 Professional Continuous Glucose Monitoring (CGM) System K221259 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dexcom, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k221901/ 2022-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k221901-elegard-fda-510k.jpg K221901 - EleGARD K221901 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Advancedcpr Solutions, LLC. Cleared Jul 2022. https://www.510kdatabase.net/k221907/ 2022-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k221907-rhinaer-stylus-fg1393-fda-510k.jpg K221907 - RhinAer® Stylus (FG1393) K221907 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Aerin Medical, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k221914/ 2022-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k221914-catapult-guide-sheath-fda-510k.jpg K221914 - Catapult Guide Sheath K221914 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Contract Medical International, GmbH. Cleared Jul 2022. https://www.510kdatabase.net/k212113/ 2022-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k212113-magxtract-collection-tube-fda-510k.jpg K212113 - MagXtract Collection Tube K212113 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Magbio Genomics, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k213998/ 2022-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k213998-cvi42-auto-imaging-software-application-fda-510k.jpg K213998 - cvi42 Auto Imaging Software Application K213998 is a FDA 510(k) cleared radiology medical device. Manufacturer: Circle Cardiovascular Imaging, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k214122/ 2022-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k214122-bd-max-enteric-bacterial-panel-bd-max-fda-510k.jpg K214122 - BD MAX Enteric Bacterial Panel, BD MAX Extended Enteric Bacterial Panel K214122 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson and Company. Cleared Jul 2022. https://www.510kdatabase.net/k220063/ 2022-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k220063-single-use-cytology-brush-fda-510k.jpg K220063 - Single Use Cytology Brush K220063 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Zhejiang Chuangxiang Medical Technology Co., Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k221230/ 2022-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k221230-tron-fda-510k.jpg K221230 - TRON K221230 is a FDA 510(k) cleared radiology medical device. Manufacturer: Xoran Technologies, LLC. Cleared Jul 2022. https://www.510kdatabase.net/k221235/ 2022-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k221235-nexus-ultrasonic-surgical-aspirator-fda-510k.jpg K221235 - neXus Ultrasonic Surgical Aspirator System K221235 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Misonix, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k221332/ 2022-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k221332-osteocentric-spine-mis-pedicle-fda-510k.jpg K221332 - OsteoCentric Spine MIS Pedicle Fastener System K221332 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OsteoCentric Technologies. Cleared Jul 2022. https://www.510kdatabase.net/k221898/ 2022-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k221898-gastrointestinal-boundary-identifier-fda-510k.jpg K221898 - Gastrointestinal Boundary Identifier (GIBI HD) K221898 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Reshape Lifesciences. Cleared Jul 2022. https://www.510kdatabase.net/k221905/ 2022-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k221905-inertia-connexx-modular-pedicle-screw-fda-510k.jpg K221905 - INERTIA CONNEXX Modular Pedicle Screw System K221905 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nexxt Spine, LLC. Cleared Jul 2022. https://www.510kdatabase.net/k221922/ 2022-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k221922-trinias-fda-510k.jpg K221922 - Trinias K221922 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shimadzu Corporation Medical Systems Division. Cleared Jul 2022. https://www.510kdatabase.net/k221923/ 2022-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k221923-swoop-portable-mr-imaging-system-fda-510k.jpg K221923 - Swoop Portable MR Imaging System K221923 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hyperfine, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k221945/ 2022-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k221945-beamer-aveo-filter-integrated-argon-fda-510k.jpg K221945 - Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8mm x 160 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 1.8 mm X 320 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 mm X 230 cm, Beamer AVEO FILTER INTEGRATED ARGON PROBE 2.3 mm x 320 cm, Beamer AVEO FILTER INTEGRATED ARGON SIDEFIRE PROBE 2.3 mm x 230 cm K221945 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Conmed Corporation. Cleared Jul 2022. https://www.510kdatabase.net/k222014/ 2022-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k222014-exalt-model-b-single-use-bronchoscope-fda-510k.jpg K222014 - EXALT Model B Single-Use Bronchoscope K222014 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Boston Scientific Corporation. Cleared Jul 2022. https://www.510kdatabase.net/k222017/ 2022-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k222017-biotres-fda-510k.jpg K222017 - Biotres K222017 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biotricity. Cleared Jul 2022. https://www.510kdatabase.net/k210822/ 2022-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k210822-deeprhythmai-fda-510k.jpg K210822 - DeepRhythmAI K210822 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medicalgorithmics S.A.. Cleared Jul 2022. https://www.510kdatabase.net/k210902/ 2022-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k210902-elia-ro52-elia-ro60-fda-510k.jpg K210902 - EliA Ro52, EliA Ro60 K210902 is a FDA 510(k) cleared immunology medical device. Manufacturer: Phadia AB. Cleared Jul 2022. https://www.510kdatabase.net/k211385/ 2022-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k211385-keriflex-mcp-and-pip-finger-joint-fda-510k.jpg K211385 - KeriFlex® MCP and PIP Finger Joint Prostheses K211385 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Keri Medical SA. Cleared Jul 2022. https://www.510kdatabase.net/k211496/ 2022-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k211496-transloc-3d-fda-510k.jpg K211496 - TransLoc 3D K211496 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Foundation Fusion Solutions, LLC (Dba Cornerloc). Cleared Jul 2022. https://www.510kdatabase.net/k213252/ 2022-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k213252-dornier-thulio-fda-510k.jpg K213252 - Dornier Thulio K213252 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Dornier Medtech America, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k213507/ 2022-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k213507-aquaa-fda-510k.jpg K213507 - AquaA K213507 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fresenius Medical Care Rental Therapies Group, LLC. Cleared Jul 2022. https://www.510kdatabase.net/k214007/ 2022-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k214007-halyard-one-step-sterilization-wrap-fda-510k.jpg K214007 - HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap K214007 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Owens & Minor (O&M) Halyard, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k220876/ 2022-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k220876-aok-95a-medical-mask-20200049-fda-510k.jpg K220876 - AOK 95A Medical Mask (20200049) K220876 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Aok Tooling Limited. Cleared Jul 2022. https://www.510kdatabase.net/k220886/ 2022-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k220886-upper-arm-type-blood-pressure-monitor-fda-510k.jpg K220886 - Upper Arm Type Blood Pressure Monitor K220886 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Jamr Technology Co., Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k220922/ 2022-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k220922-cochlear-osia-2-system-cochlear-osia-fda-510k.jpg K220922 - Cochlear Osia 2 System, Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Cochlear Osia Fitting Software 2, Cochlear MRI Kit K220922 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Cochlear Americas. Cleared Jul 2022. https://www.510kdatabase.net/k220958/ 2022-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k220958-real-intelligence-cori-fda-510k.jpg K220958 - Real Intelligence Cori K220958 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Blue Belt Technologies, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k221254/ 2022-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k221254-hummingbird-tympanostomy-tube-system-fda-510k.jpg K221254 - Hummingbird Tympanostomy Tube System K221254 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Preceptis Medical, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k221269/ 2022-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k221269-powder-free-nitrile-examination-gloves-fda-510k.jpg K221269 - Powder Free Nitrile Examination Gloves (Blue),Tested for Use with Chemotherapy Drugs and Fentanyl Citrate K221269 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Better Care Plastic Technology Co., Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k221271/ 2022-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k221271-disposable-nitrile-powder-free-fda-510k.jpg K221271 - Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs) K221271 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shandong Maida Medical Technology Co., Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k221430/ 2022-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k221430-revive-light-therapy-led-cleansing-fda-510k.jpg K221430 - reVive Light Therapy LED Cleansing System K221430 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Led Technologies, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k221464/ 2022-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k221464-corpath-grx-system-fda-510k.jpg K221464 - CorPath GRX System K221464 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Corindus, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k221687/ 2022-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k221687-pegasus-x-expandable-plif-system-fda-510k.jpg K221687 - Pegasus-X Expandable PLIF System K221687 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: GS Medical Co., Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k221853/ 2022-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k221853-otc-ddr-fda-510k.jpg K221853 - OTC DDR K221853 is a FDA 510(k) cleared radiology medical device. Manufacturer: Konica Minolta Healthcare Americas, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k221856/ 2022-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k221856-biomonitor-iiim-biomonitor-iii-fda-510k.jpg K221856 - BIOMONITOR IIIm, BIOMONITOR III K221856 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biotronik, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k212407/ 2022-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k212407-gastric-lightguide-glg-fda-510k.jpg K212407 - Gastric Lightguide (GLG) K212407 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Naser Dib Gabinet Lekarksi Nasmed. Cleared Jul 2022. https://www.510kdatabase.net/k213858/ 2022-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k213858-liaison-calprotectin-liaison-qset-fda-510k.jpg K213858 - LIAISON Calprotectin, LIAISON Q.S.E.T. Device Plus K213858 is a FDA 510(k) cleared immunology medical device. Manufacturer: DiaSorin, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k214112/ 2022-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k214112-invia-ease-negative-pressure-wound-fda-510k.jpg K214112 - Invia Ease Negative Pressure Wound Therapy (NPWT) System K214112 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medela AG. Cleared Jul 2022. https://www.510kdatabase.net/k221404/ 2022-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k221404-identity-imprint-knee-replacement-fda-510k.jpg K221404 - Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) K221404 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Conformis, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k221502/ 2022-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k221502-parcus-synd-ez-ss-fda-510k.jpg K221502 - Parcus Synd-EZ SS K221502 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Parcus Medical, LLC. Cleared Jul 2022. https://www.510kdatabase.net/k221567/ 2022-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k221567-lcd-monitor-hmd3c21s-lcd-monitor-fda-510k.jpg K221567 - LCD monitor (HMD3C21S), LCD monitor (HMD5G21S) K221567 is a FDA 510(k) cleared radiology medical device. Manufacturer: Qingdao Hisense Medical Equipment Co., Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k221572/ 2022-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k221572-vyplate-anterior-cervical-plate-system-fda-510k.jpg K221572 - VyPlate Anterior Cervical Plate System K221572 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Vy Spine, LLC. Cleared Jul 2022. https://www.510kdatabase.net/k221939/ 2022-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k221939-cemented-round-patella-with-jrny-pegs-fda-510k.jpg K221939 - Cemented Round Patella with JRNY Pegs K221939 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/den210032/ 2022-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/den210032-accumeasure-system-fda-510k.jpg DEN210032 - AccuMeasure System DEN210032 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: RQMIS, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k220439/ 2022-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k220439-viz-sdh-fda-510k.jpg K220439 - Viz SDH K220439 is a FDA 510(k) cleared radiology medical device. Manufacturer: Viz. Ai, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k220606/ 2022-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k220606-ambu-ascope-5-broncho-hd-5628-ambu-fda-510k.jpg K220606 - Ambu aScope 5 Broncho HD 5.6/2.8, Ambu aScope 5 Broncho HD 5.0/2.2, Ambu aBox 2 K220606 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Ambu A/S. Cleared Jul 2022. https://www.510kdatabase.net/k220808/ 2022-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k220808-tigertriever-13-revascularization-device-fda-510k.jpg K220808 - Tigertriever 13 Revascularization Device K220808 is a FDA 510(k) cleared neurology medical device. Manufacturer: Rapid Medical , Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k221409/ 2022-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k221409-paneffort-3-ply-surgical-and-fda-510k.jpg K221409 - Paneffort 3-ply Surgical and Procedural Masks K221409 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Paneffort, LLC. Cleared Jul 2022. https://www.510kdatabase.net/k221460/ 2022-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k221460-biofire-covid-19-test-2-fda-510k.jpg K221460 - BioFire COVID-19 Test 2 K221460 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Biofire Defense, LLC. Cleared Jul 2022. https://www.510kdatabase.net/k221877/ 2022-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k221877-powder-free-nitrile-examination-glove-fda-510k.jpg K221877 - Powder-Free Nitrile Examination Glove, Non-Sterile K221877 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Goodgloves Industries Sdn Bhd. Cleared Jul 2022. https://www.510kdatabase.net/k203680/ 2022-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k203680-biofire-ji-control-panel-m420-fda-510k.jpg K203680 - BioFire JI Control Panel M420 K203680 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Maine Molecular Quality Controls, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k211346/ 2022-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k211346-blue-400-fda-510k.jpg K211346 - BLUE 400 K211346 is a FDA 510(k) cleared neurology medical device. Manufacturer: Carl Zeiss Meditec, AG. Cleared Jul 2022. https://www.510kdatabase.net/k211399/ 2022-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k211399-sterile-level-3-surgical-gown-fda-510k.jpg K211399 - Sterile Level 3 Surgical Gown K211399 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Barco Tekstil Sanayi VE Ticaret A.S.. Cleared Jul 2022. https://www.510kdatabase.net/k211891/ 2022-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k211891-dm-converter-tin-coated-fda-510k.jpg K211891 - DM Converter - TiN coated K211891 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Jul 2022. https://www.510kdatabase.net/k212975/ 2022-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k212975-medwand-fda-510k.jpg K212975 - MedWand K212975 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medwand Solutions, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k213813/ 2022-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k213813-durafuse-clip-and-applier-system-fda-510k.jpg K213813 - DuraFuse Clip and Applier System K213813 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Neuramedica, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k213922/ 2022-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k213922-fx-sps-fda-510k.jpg K213922 - FX SPS K213922 is a FDA 510(k) cleared radiology medical device. Manufacturer: Pixee Medical. Cleared Jul 2022. https://www.510kdatabase.net/k220064/ 2022-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k220064-synergy-marble-model-opasm-fda-510k.jpg K220064 - Synergy Marble (Model: Opasm) K220064 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Yrs Group, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k220216/ 2022-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k220216-c-stem-amt-le-prosthesis-fda-510k.jpg K220216 - C-Stem AMT LE Prosthesis K220216 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Ireland UC. Cleared Jul 2022. https://www.510kdatabase.net/k220486/ 2022-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k220486-kentrospine-pss-pedicle-screw-system-fda-510k.jpg K220486 - Kentrospine PSS Pedicle Screw System K220486 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Rivarp Medical Private Limited. Cleared Jul 2022. https://www.510kdatabase.net/k220624/ 2022-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k220624-ai4cmr-v10-fda-510k.jpg K220624 - AI4CMR v1.0 K220624 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ai4medimaging Medical Solutions S.A.. Cleared Jul 2022. https://www.510kdatabase.net/k220882/ 2022-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k220882-vivid-e80-vivid-e90-vivid-e95-fda-510k.jpg K220882 - Vivid E80, Vivid E90, Vivid E95 K220882 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems Ultrasound And. Cleared Jul 2022. https://www.510kdatabase.net/k220906/ 2022-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k220906-secure-lock-fda-510k.jpg K220906 - SECURE-LOCK K220906 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Xiros, Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k220940/ 2022-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k220940-echopac-software-only-echopac-plug-in-fda-510k.jpg K220940 - EchoPAC Software Only, EchoPAC Plug-in K220940 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared Jul 2022. https://www.510kdatabase.net/k221196/ 2022-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k221196-disposable-medical-face-mask-ear-loop-fda-510k.jpg K221196 - Disposable Medical Face Mask (ear loop) K221196 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Xiantao Topmed Nonwoven Protective Products Co., Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k221234/ 2022-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k221234-targetcool-fda-510k.jpg K221234 - TargetCool K221234 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Recensmedical, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k221394/ 2022-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k221394-14hq701g-b-fda-510k.jpg K221394 - 14HQ701G-B K221394 is a FDA 510(k) cleared radiology medical device. Manufacturer: Lg Electronics.Inc. Cleared Jul 2022. https://www.510kdatabase.net/k221461/ 2022-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k221461-10hq701g-b-fda-510k.jpg K221461 - 10HQ701G-B K221461 is a FDA 510(k) cleared radiology medical device. Manufacturer: Lg Electronics.Inc. Cleared Jul 2022. https://www.510kdatabase.net/k221525/ 2022-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k221525-prexion3d-explorer-pro-fda-510k.jpg K221525 - PreXion3D Explorer PRO K221525 is a FDA 510(k) cleared radiology medical device. Manufacturer: Prexion Corporation. Cleared Jul 2022. https://www.510kdatabase.net/k221535/ 2022-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k221535-align-lumbar-interbody-fusion-system-fda-510k.jpg K221535 - Align Lumbar Interbody Fusion System K221535 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Acuity Surgical Devices, LLC. Cleared Jul 2022. https://www.510kdatabase.net/k211543/ 2022-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k211543-wei-nasal-jet-tube-fda-510k.jpg K211543 - Wei Nasal Jet Tube K211543 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Well Lead Medical Co., Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k211952/ 2022-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k211952-bti-interna-narrowplus-dental-implant-fda-510k.jpg K211952 - BTI Interna Narrow/Plus Dental Implant System UnicCa K211952 is a FDA 510(k) cleared dental medical device. Manufacturer: B.T.I. Biotechnology Institute, Sl.. Cleared Jul 2022. https://www.510kdatabase.net/k213158/ 2022-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k213158-syringe-with-permanently-attached-needle-fda-510k.jpg K213158 - Syringe with permanently attached needle K213158 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Berpu Medical Technology Co., Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k213773/ 2022-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k213773-insufflation-retention-device-fda-510k.jpg K213773 - Insufflation Retention Device K213773 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Bpendo, LLC. Cleared Jul 2022. https://www.510kdatabase.net/k213881/ 2022-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k213881-celerity-incubator-fda-510k.jpg K213881 - Celerity Incubator K213881 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Jul 2022. https://www.510kdatabase.net/k220184/ 2022-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k220184-pump-alignment-syringe-fda-510k.jpg K220184 - Pump Alignment Syringe K220184 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Caina Medical Co.,Ltd. Cleared Jul 2022. https://www.510kdatabase.net/k220671/ 2022-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k220671-manual-wheelchair-fda-510k.jpg K220671 - Manual Wheelchair K220671 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Hebei Ruilangde Medical Equipment Technology Group Co., Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k220976/ 2022-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k220976-life-scope-pt-bsm-1700-series-bedside-fda-510k.jpg K220976 - Life Scope PT BSM-1700 Series Bedside Monitor K220976 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Nihon Kohden Corporation. Cleared Jul 2022. https://www.510kdatabase.net/k221823/ 2022-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k221823-cionic-neural-sleeve-ns-100-fda-510k.jpg K221823 - Cionic Neural Sleeve NS-100 K221823 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Cionic. Cleared Jul 2022. https://www.510kdatabase.net/k212178/ 2022-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k212178-root-apex-locator-fda-510k.jpg K212178 - Root Apex Locator K212178 is a FDA 510(k) cleared dental medical device. Manufacturer: Foshan Coxo Medical Instrument Co., Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k213060/ 2022-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k213060-areustm-endobronchial-ultrasound-fda-510k.jpg K213060 - AreusTM Endobronchial Ultrasound Aspiration Needle, TridentTM Endobronchial Ultrasound Aspiration Needle K213060 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Micro-Tech (Nanjing) Co., Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k214080/ 2022-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k214080-pentaflush-fda-510k.jpg K214080 - Pentaflush K214080 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Pentaferte Italia S.R.L.. Cleared Jul 2022. https://www.510kdatabase.net/k220039/ 2022-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k220039-autoseg-fda-510k.jpg K220039 - AutoSeg K220039 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ai Medic, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k220161/ 2022-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k220161-biofeedback-nerve-and-muscle-stimulator-fda-510k.jpg K220161 - Biofeedback Nerve and Muscle Stimulator K220161 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Shenzhen Konmed Technology Co., Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k220679/ 2022-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k220679-pediatric-nailing-platform-femur-fda-510k.jpg K220679 - Pediatric Nailing Platform Femur K220679 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OrthoPediatrics Corp.. Cleared Jul 2022. https://www.510kdatabase.net/k220956/ 2022-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k220956-libby-echoprio-fda-510k.jpg K220956 - Libby Echo:Prio K220956 is a FDA 510(k) cleared radiology medical device. Manufacturer: Dyad Medical, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k221037/ 2022-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k221037-trudi-shaver-blade-fda-510k.jpg K221037 - TruDi Shaver Blade K221037 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Acclarent, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k221363/ 2022-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k221363-af-laser-fda-510k.jpg K221363 - AF Laser K221363 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: ShenB Co., Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k221512/ 2022-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k221512-vivix-s-fw-model-fxrd-2530faw-fxrd-fda-510k.jpg K221512 - Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW) K221512 is a FDA 510(k) cleared radiology medical device. Manufacturer: Vieworks Co., Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k221794/ 2022-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k221794-vario-cup-system-fda-510k.jpg K221794 - Vario-Cup System K221794 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Waldemar Link GmbH & Co. KG. Cleared Jul 2022. https://www.510kdatabase.net/k212215/ 2022-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k212215-tiche-pta-balloon-dilatation-catheter-fda-510k.jpg K212215 - Tiche PTA Balloon Dilatation Catheter K212215 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Brosmed Medical Co., Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k213357/ 2022-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k213357-study-watch-with-irregular-pulse-fda-510k.jpg K213357 - Study Watch with Irregular Pulse Monitor (Home), Study Watch with Irregular Pulse Monitor K213357 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Verily Life Sciences, LLC. Cleared Jul 2022. https://www.510kdatabase.net/k213409/ 2022-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k213409-zeus-system-zio-watch-fda-510k.jpg K213409 - ZEUS System (Zio Watch) K213409 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: iRhythm Technologies, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k213435/ 2022-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k213435-magic-flow-dependent-microcatheter-fda-510k.jpg K213435 - MAGIC Flow-Dependent Microcatheter K213435 is a FDA 510(k) cleared neurology medical device. Manufacturer: Balt USA, LLC. Cleared Jul 2022. https://www.510kdatabase.net/k213761/ 2022-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k213761-joule-diva-system-fda-510k.jpg K213761 - Joule diVa System K213761 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sciton, Inc. Cleared Jul 2022. https://www.510kdatabase.net/k220777/ 2022-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k220777-surgical-face-mask-fda-510k.jpg K220777 - Surgical face mask K220777 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hubei Qianjiang Kingphar Medical Material Co., Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k220815/ 2022-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k220815-braininsight-fda-510k.jpg K220815 - BrainInsight K220815 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hyperfine, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k220943/ 2022-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k220943-dual-color-bluewhite-powder-free-fda-510k.jpg K220943 - Dual Color Blue/White Powder Free Nitrile Examination Glove with Chemotherapy Drug and Fentanyl Test Claim K220943 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Eco Medi Glove Sdn. Bhd.. Cleared Jul 2022. https://www.510kdatabase.net/k221151/ 2022-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k221151-beauty-led-mask-model-kfb265-fda-510k.jpg K221151 - Beauty LED Mask, Model: KFB265 K221151 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Hunan Guangye Biotechnology Co., Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k221516/ 2022-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k221516-artis-icono-ceiling-configuration-fda-510k.jpg K221516 - ARTIS icono (Ceiling Configuration) K221516 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k222037/ 2022-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k222037-selectra-lead-implantation-system-fda-510k.jpg K222037 - Selectra Lead Implantation System K222037 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biotronik, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k210731/ 2022-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k210731-kls-martin-individual-patient-solutions-fda-510k.jpg K210731 - KLS Martin Individual Patient Solutions K210731 is a FDA 510(k) cleared dental medical device. Manufacturer: KLS-Martin L.P.. Cleared Jul 2022. https://www.510kdatabase.net/k211720/ 2022-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k211720-planmed-clarity-2d-planmed-clarify-s-fda-510k.jpg K211720 - Planmed Clarity 2D, Planmed Clarify S K211720 is a FDA 510(k) cleared radiology medical device. Manufacturer: Planmed OY. Cleared Jul 2022. https://www.510kdatabase.net/k212509/ 2022-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k212509-ossix-breeze-fda-510k.jpg K212509 - OSSIX Breeze K212509 is a FDA 510(k) cleared dental medical device. Manufacturer: Datum Dental, Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k212614/ 2022-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k212614-ultrasonic-scalpel-system-fda-510k.jpg K212614 - Ultrasonic Scalpel System K212614 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k221147/ 2022-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k221147-vivid-t8-vivid-t9-fda-510k.jpg K221147 - Vivid T8, Vivid T9 K221147 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared Jul 2022. https://www.510kdatabase.net/k221148/ 2022-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k221148-vivid-iq-fda-510k.jpg K221148 - Vivid iq K221148 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. Cleared Jul 2022. https://www.510kdatabase.net/k221803/ 2022-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k221803-phoenixaerodr-tx-m01-and-phoenixmkdr-fda-510k.jpg K221803 - PHOENIX/AeroDR TX m01 and PHOENIX/mKDR Xpress. K221803 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sedecal., Sa.. Cleared Jul 2022. https://www.510kdatabase.net/k213955/ 2022-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k213955-09-sodium-chloride-injection-usp-bd-fda-510k.jpg K213955 - 0.9% Sodium Chloride Injection, USP, BD PosiFlush SafeScrub K213955 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson and Company. Cleared Jul 2022. https://www.510kdatabase.net/k221229/ 2022-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k221229-powder-free-nitrile-examination-gloves-fda-510k.jpg K221229 - Powder Free Nitrile Examination Gloves, (Cobalt Blue and Violet Blue), Powder Free Latex Examination Gloves K221229 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zibo Blue Sail Health Technology Co., Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k210665/ 2022-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k210665-nerve-tape-fda-510k.jpg K210665 - Nerve Tape K210665 is a FDA 510(k) cleared neurology medical device. Manufacturer: Biocircuit Technologies, Incorporated. Cleared Jul 2022. https://www.510kdatabase.net/k212778/ 2022-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k212778-alinity-m-ebv-amp-kit-list-no-09n43-fda-510k.jpg K212778 - Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075) K212778 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Molecular, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k212883/ 2022-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k212883-ers2-ergoline-rehabilitation-system-fda-510k.jpg K212883 - ers2 - ergoline Rehabilitation System K212883 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ergoline GmbH. Cleared Jul 2022. https://www.510kdatabase.net/k213576/ 2022-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k213576-tatum-surgical-dental-implant-system-fda-510k.jpg K213576 - Tatum Surgical Dental Implant System K213576 is a FDA 510(k) cleared dental medical device. Manufacturer: Suncoast Dental, Inc. Dba Tatum Surgical. Cleared Jul 2022. https://www.510kdatabase.net/k213872/ 2022-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k213872-compas2-fda-510k.jpg K213872 - ComPAS2 K213872 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Morgan Scientific, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k213997/ 2022-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k213997-kontact-dental-implant-system-fda-510k.jpg K213997 - Kontact Dental Implant System K213997 is a FDA 510(k) cleared dental medical device. Manufacturer: Biotech Dental, Sas. Cleared Jul 2022. https://www.510kdatabase.net/k220127/ 2022-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k220127-neurostar-tms-therapy-system-neurostar-fda-510k.jpg K220127 - NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health K220127 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neuronetics, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k220619/ 2022-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k220619-vivid-s60n-vivid-s70n-fda-510k.jpg K220619 - Vivid S60N, Vivid S70N K220619 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared Jul 2022. https://www.510kdatabase.net/k220622/ 2022-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k220622-hailie-sensor-nf0106-fda-510k.jpg K220622 - Hailie Sensor NF0106 K220622 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Adherium (Nz), Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k220631/ 2022-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k220631-nomadair-pmu810-fda-510k.jpg K220631 - NomadAir PMU810 K220631 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neurotronics, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k220742/ 2022-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k220742-nxtgen-infant-transport-incubator-fda-510k.jpg K220742 - NxtGen Infant Transport Incubator K220742 is a FDA 510(k) cleared general hospital medical device. Manufacturer: International Biomedical. Cleared Jul 2022. https://www.510kdatabase.net/k220877/ 2022-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k220877-selecta-duet-led-digital-duet-selecta-fda-510k.jpg K220877 - Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems K220877 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Lumenis Be, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k220970/ 2022-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k220970-renuvion-apr-handpiece-fda-510k.jpg K220970 - Renuvion APR Handpiece K220970 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Apyx Medical Corporation(Formerly Bovie Medical Corporation). Cleared Jul 2022. https://www.510kdatabase.net/k221030/ 2022-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k221030-model-9100-pftdico-fda-510k.jpg K221030 - Model 9100 PFT/DICO K221030 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Vitalograph (Ireland) , Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k221433/ 2022-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k221433-facet-28g-universal-lancet-fda-510k.jpg K221433 - Facet 28G Universal Lancet K221433 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Facet Technologies, LLC. Cleared Jul 2022. https://www.510kdatabase.net/k221763/ 2022-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k221763-cusa-clarity-ultrasonic-surgical-fda-510k.jpg K221763 - CUSA Clarity Ultrasonic Surgical Aspirator System K221763 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Integra LifeSciences Corporation. Cleared Jul 2022. https://www.510kdatabase.net/k221814/ 2022-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k221814-ok-handpiece-fda-510k.jpg K221814 - OK Handpiece K221814 is a FDA 510(k) cleared dental medical device. Manufacturer: Jaintek Co.,Ltd. Cleared Jul 2022. https://www.510kdatabase.net/k221876/ 2022-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k221876-digital-radiography-cxdi-pro-digital-fda-510k.jpg K221876 - Digital Radiography CXDI-Pro, Digital Radiography D1 K221876 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k203013/ 2022-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k203013-agnes-fda-510k.jpg K203013 - AGNES K203013 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Agnes Medical Co., Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k212073/ 2022-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k212073-alma-diode-tabletop-laser-fda-510k.jpg K212073 - Alma Diode Tabletop Laser K212073 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Alma Lasers , Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k213498/ 2022-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k213498-pelnac-meshed-bilayer-wound-matrix-fda-510k.jpg K213498 - PELNAC Meshed Bilayer Wound Matrix K213498 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Gunze Limited. Cleared Jul 2022. https://www.510kdatabase.net/k213936/ 2022-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k213936-liaison-memed-bv-liaison-memed-bv-fda-510k.jpg K213936 - LIAISON MeMed BV, LIAISON MeMed BV Control Set K213936 is a FDA 510(k) cleared microbiology medical device. Manufacturer: DiaSorin, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k213961/ 2022-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k213961-truabutment-ds-trubase-fda-510k.jpg K213961 - TruAbutment DS, TruBase K213961 is a FDA 510(k) cleared dental medical device. Manufacturer: Truabutment, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k214017/ 2022-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k214017-examination-gloves-type-alatex-gloves-fda-510k.jpg K214017 - Examination gloves-Type A(Latex gloves) K214017 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k220040/ 2022-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k220040-cerepak-uniform-uniform-xl-uniform-3d-fda-510k.jpg K220040 - CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil Systems K220040 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medos International SARL. Cleared Jul 2022. https://www.510kdatabase.net/k220204/ 2022-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k220204-disposabel-syringe-with-permanently-fda-510k.jpg K220204 - Disposabel Syringe with permanently attached needle, Safety Syringe with permanently attached needle K220204 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Anhui Tiankang Medical Technology Co., Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k220258/ 2022-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k220258-20g-open-system-ally-device-kit-fda-510k.jpg K220258 - 20G Open-System Ally Device Kit (AV100000), 22G Open-System Ally Device Kit (AV110000) K220258 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Avia Vascular. Cleared Jul 2022. https://www.510kdatabase.net/k220348/ 2022-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k220348-anatase-spine-surgery-navigation-fda-510k.jpg K220348 - Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and SNS-spine2-V K220348 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Remex Medical Corporation. Cleared Jul 2022. https://www.510kdatabase.net/k220560/ 2022-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k220560-dermatac-drape-fda-510k.jpg K220560 - Dermatac Drape K220560 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3M. Cleared Jul 2022. https://www.510kdatabase.net/k220862/ 2022-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k220862-e-gps-navigated-instruments-fda-510k.jpg K220862 - E-GPS Navigated Instruments K220862 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Precision Spine, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k221097/ 2022-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k221097-smileseries-fda-510k.jpg K221097 - SmileSeries K221097 is a FDA 510(k) cleared dental medical device. Manufacturer: Ordont Orthodontic Laboratories, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k221203/ 2022-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k221203-ahi-system-fda-510k.jpg K221203 - AHI System K221203 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Fifth Eye, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k221429/ 2022-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k221429-kdf-zirconia-disc-fda-510k.jpg K221429 - KDF Zirconia Disc K221429 is a FDA 510(k) cleared dental medical device. Manufacturer: Denken-Highdental Co., Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k221431/ 2022-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k221431-trojantm-her-pleasure-warming-male-fda-510k.jpg K221431 - TROJAN(TM) Her Pleasure Warming male natural rubber latex condom with warming lubricant K221431 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Church & Dwight Co., Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k221666/ 2022-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k221666-normatec-go-fda-510k.jpg K221666 - Normatec Go K221666 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: NormaTec Industries, LP. Cleared Jul 2022. https://www.510kdatabase.net/k210354/ 2022-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k210354-snucone-bone-level-implant-system-fda-510k.jpg K210354 - SNUCONE Bone Level Implant System K210354 is a FDA 510(k) cleared dental medical device. Manufacturer: Snucone Co., Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k221407/ 2022-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k221407-trusculpt-id-fda-510k.jpg K221407 - truSculpt iD K221407 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cutera, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k221434/ 2022-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k221434-17hq701g-b-fda-510k.jpg K221434 - 17HQ701G-B K221434 is a FDA 510(k) cleared radiology medical device. Manufacturer: Lg Electronics.Inc. Cleared Jul 2022. https://www.510kdatabase.net/k221727/ 2022-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k221727-syngoct-extended-functionality-fda-510k.jpg K221727 - syngo.CT Extended Functionality K221727 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k203279/ 2022-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k203279-veuron-brain-mn1-fda-510k.jpg K203279 - Veuron-Brain-mN1 K203279 is a FDA 510(k) cleared radiology medical device. Manufacturer: Heuron Co., Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k213143/ 2022-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k213143-hemoclip-fda-510k.jpg K213143 - Hemoclip K213143 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hangzhou AGS MedTech Co., Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k213574/ 2022-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k213574-nitrile-vinyl-blend-powder-free-fda-510k.jpg K213574 - Nitrile Vinyl Blend Powder Free Examination Gloves (Black) K213574 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Grand Work Plastic Products Co., Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k213799/ 2022-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k213799-n-series-patient-monitors-fda-510k.jpg K213799 - N Series Patient Monitors K213799 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k213899/ 2022-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k213899-vitek-2-ast-yeast-caspofungin-0125-8-fda-510k.jpg K213899 - VITEK 2 AST-Yeast Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin (<=0.125 - >=8 µg/mL), VITEK 2 AST-YS Caspofungin K213899 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k220415/ 2022-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k220415-protrieve-sheath-fda-510k.jpg K220415 - Protrieve Sheath K220415 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inari Medical, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k220814/ 2022-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k220814-naeotom-alpha-scango-software-fda-510k.jpg K220814 - NAEOTOM Alpha, Scan&GO Software K220814 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k221083/ 2022-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k221083-smartlux-mini-fda-510k.jpg K221083 - Smartlux Mini K221083 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medmix Co., Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k221098/ 2022-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k221098-scopis-ent-software-scopis-ent-fda-510k.jpg K221098 - Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit K221098 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Stryker Corporation. Cleared Jul 2022. https://www.510kdatabase.net/k221108/ 2022-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k221108-nitrile-medical-examination-gloves-fda-510k.jpg K221108 - Nitrile Medical Examination Gloves K221108 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Anhui Fulewei Electronic Technology Co.,Ltd. Cleared Jul 2022. https://www.510kdatabase.net/k221454/ 2022-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k221454-disposable-medical-nitrile-examination-fda-510k.jpg K221454 - Disposable Medical Nitrile Examination Gloves - Non Sterile K221454 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guangzhou Kangling Biotechnology Co., Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/den210045/ 2022-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/den210045-apollo-esg-system-apollo-esg-sx-system-fda-510k.jpg DEN210045 - APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System DEN210045 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Apollo Endosurgery, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k220095/ 2022-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k220095-anne-sleep-fda-510k.jpg K220095 - ANNE Sleep K220095 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sibel, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k220480/ 2022-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k220480-revogene-fda-510k.jpg K220480 - Revogene K220480 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Meridian Bioscience, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k220538/ 2022-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k220538-dolorclast-radial-fda-510k.jpg K220538 - DolorClast Radial K220538 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: E.M.S Electro Medical Systems S.A. Cleared Jul 2022. https://www.510kdatabase.net/k221364/ 2022-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k221364-mitek-tight-n-anchor-fda-510k.jpg K221364 - Mitek TIGHT-N Anchor K221364 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International SARL. Cleared Jul 2022. https://www.510kdatabase.net/k221846/ 2022-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k221846-artix-ballon-guiding-sheath-fda-510k.jpg K221846 - Artix Ballon Guiding Sheath K221846 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inari Medical. Cleared Jul 2022. https://www.510kdatabase.net/k213405/ 2022-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k213405-mine-alnu-model-mine-21-fda-510k.jpg K213405 - MINE ALNU (Model: Mine 2.1) K213405 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hdt Co., Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k220573/ 2022-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k220573-noodle-fda-510k.jpg K220573 - Noodle K220573 is a FDA 510(k) cleared neurology medical device. Manufacturer: Pourang Bral, Dds, LLC. Cleared Jul 2022. https://www.510kdatabase.net/k201440/ 2022-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k201440-rotem-sigma-thromboelastometry-system-fda-510k.jpg K201440 - ROTEM sigma Thromboelastometry System K201440 is a FDA 510(k) cleared hematology medical device. Manufacturer: Tem Innovations GmbH. Cleared Jul 2022. https://www.510kdatabase.net/k210228/ 2022-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k210228-kls-martin-ips-preprosthetic-fda-510k.jpg K210228 - KLS Martin IPS Preprosthetic K210228 is a FDA 510(k) cleared dental medical device. Manufacturer: KLS-Martin L.P.. Cleared Jul 2022. https://www.510kdatabase.net/k210793/ 2022-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k210793-vidas-nephrocheck-fda-510k.jpg K210793 - VIDAS NEPHROCHECK K210793 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Biom?rieux SA. Cleared Jul 2022. https://www.510kdatabase.net/k212775/ 2022-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k212775-adin-short-implants-fda-510k.jpg K212775 - Adin Short Implants K212775 is a FDA 510(k) cleared dental medical device. Manufacturer: Adin Dental Implants Systems , Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k212783/ 2022-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k212783-prostatid-fda-510k.jpg K212783 - ProstatID K212783 is a FDA 510(k) cleared radiology medical device. Manufacturer: Scanmed, LLC. Cleared Jul 2022. https://www.510kdatabase.net/k213009/ 2022-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k213009-transcranial-doppler-ultrasound-system-fda-510k.jpg K213009 - Transcranial Doppler Ultrasound System K213009 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Delica Medical Equipment Co., Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k213782/ 2022-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k213782-single-use-video-bronchoscopes-digital-fda-510k.jpg K213782 - Single-Use Video Bronchoscopes, Digital Controller K213782 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Micro-Tech (Nanjing) Co., Lts. Cleared Jul 2022. https://www.510kdatabase.net/k220284/ 2022-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k220284-powder-free-nitrile-examination-gloves-fda-510k.jpg K220284 - Powder Free Nitrile Examination Gloves (Blue) K220284 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Kgm Gloves Sdn. Bhd.. Cleared Jul 2022. https://www.510kdatabase.net/k220424/ 2022-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k220424-through-the-scope-tracheal-stent-system-fda-510k.jpg K220424 - Through the Scope Tracheal Stent System K220424 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Micro-Tech (Nanjing) Co., Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k220643/ 2022-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k220643-dropsafe-acti-lance-safety-lancets-fda-510k.jpg K220643 - DropSafe Acti-Lance Safety Lancets K220643 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Htl-Strefa S.A. Cleared Jul 2022. https://www.510kdatabase.net/k220825/ 2022-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k220825-sapphire-pro-powder-free-royal-blue-fda-510k.jpg K220825 - Sapphire Pro Powder-Free Royal Blue Nitrile Exam Gloves K220825 is a FDA 510(k) cleared general hospital medical device. Manufacturer: American Nitrile Operations, LLC. Cleared Jul 2022. https://www.510kdatabase.net/k221051/ 2022-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k221051-dental-zirconia-blank-dental-zirconia-fda-510k.jpg K221051 - Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank K221051 is a FDA 510(k) cleared dental medical device. Manufacturer: Changsha Honchon Technology Co., Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k221346/ 2022-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k221346-stryker-variax-2-mis-calcaneus-fda-510k.jpg K221346 - Stryker VariAx 2 MIS Calcaneus K221346 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker GmbH. Cleared Jul 2022. https://www.510kdatabase.net/k221399/ 2022-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k221399-zip-mis-interspinous-fusion-system-fda-510k.jpg K221399 - ZIP™ MIS Interspinous Fusion System K221399 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aurora Spine, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k212472/ 2022-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k212472-agejet-fda-510k.jpg K212472 - AgeJet K212472 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Triworks Group Srl. Cleared Jul 2022. https://www.510kdatabase.net/k213056/ 2022-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k213056-led-facial-mask-fda-510k.jpg K213056 - LED Facial Mask K213056 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Osto Technology Company Limited. Cleared Jul 2022. https://www.510kdatabase.net/k213387/ 2022-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k213387-altivate-anatomic-shoulder-ag-e-with-fda-510k.jpg K213387 - AltiVate® Anatomic Shoulder AG e+™ with Markers K213387 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Encore Medical, L.P.. Cleared Jul 2022. https://www.510kdatabase.net/k213873/ 2022-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k213873-skywalker-total-knee-system-fda-510k.jpg K213873 - SkyWalker Total Knee System K213873 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Microport Navibot International, LLC. Cleared Jul 2022. https://www.510kdatabase.net/k220534/ 2022-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k220534-wet-essential95-personal-lubricant-fda-510k.jpg K220534 - Wet Essential95 Personal Lubricant K220534 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Trigg Laboratories, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k220771/ 2022-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k220771-stratasys-truedent-fda-510k.jpg K220771 - Stratasys TrueDent K220771 is a FDA 510(k) cleared dental medical device. Manufacturer: Stratasys, Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k221246/ 2022-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k221246-ipl-hair-removal-model-sl-b080-sl-b126-fda-510k.jpg K221246 - IPL Hair Removal (Model: SL-B080, SL-B126, SL-B136) K221246 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Semlamp Intelligent Technology Co., Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k221293/ 2022-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k221293-e-brik-visualization-assistant-fda-510k.jpg K221293 - E-Brik Visualization Assistant K221293 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Jdi Surgical, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k221654/ 2022-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k221654-medi-pneumatic-compression-system-pcs-fda-510k.jpg K221654 - medi pneumatic compression system (pcs)-genius (Model 652) K221654 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medi USA, LP. Cleared Jul 2022. https://www.510kdatabase.net/k221679/ 2022-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k221679-ipl-hair-remover-model-g993-g996-g998-fda-510k.jpg K221679 - IPL Hair Remover, Model: G993, G996, G998 and G885 K221679 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Mywin Technology Co., Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k210069/ 2022-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k210069-minuteful-kidney-test-fda-510k.jpg K210069 - Minuteful - kidney test K210069 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Healthy.Io, Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k212815/ 2022-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k212815-my3d-personalized-pelvic-reconstruction-fda-510k.jpg K212815 - My3D® Personalized Pelvic Reconstruction K212815 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Onkos Surgical. Cleared Jul 2022. https://www.510kdatabase.net/k212819/ 2022-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k212819-disposable-biopsy-refill-needle-fda-510k.jpg K212819 - Disposable Biopsy Refill Needle K212819 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Suzhou Leapmed Healthcare Corporation. Cleared Jul 2022. https://www.510kdatabase.net/k212820/ 2022-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k212820-disposable-semi-automatic-biopsy-fda-510k.jpg K212820 - Disposable Semi Automatic Biopsy Instrument K212820 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Suzhou Leapmed Healthcare Corporation. Cleared Jul 2022. https://www.510kdatabase.net/k212822/ 2022-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k212822-disposable-coaxial-biopsy-needle-fda-510k.jpg K212822 - Disposable Coaxial Biopsy Needle K212822 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Suzhou Leapmed Healthcare Corporation. Cleared Jul 2022. https://www.510kdatabase.net/k213007/ 2022-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k213007-cerebra-sleep-system-fda-510k.jpg K213007 - Cerebra Sleep System K213007 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cerebra Medical , Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k213822/ 2022-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k213822-cobas-influenza-ab-rsv-nucleic-acid-fda-510k.jpg K213822 - cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System K213822 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Molecular Systems, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k214038/ 2022-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k214038-oscar-peripheral-multifunctional-fda-510k.jpg K214038 - Oscar Peripheral Multifunctional Catheter system K214038 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biotronik, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k220024/ 2022-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k220024-choicespine-navigation-system-fda-510k.jpg K220024 - ChoiceSpine Navigation System K220024 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Choice Spine, LLC. Cleared Jul 2022. https://www.510kdatabase.net/k220475/ 2022-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k220475-lancet-i-ii-iii-v-vi-fda-510k.jpg K220475 - Lancet (I, II, III, V, VI) K220475 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Tianjin Huahong Technology Co., Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k221028/ 2022-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k221028-surgivisio-device-fda-510k.jpg K221028 - SURGIVISIO Device K221028 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ecential Robotics. Cleared Jul 2022. https://www.510kdatabase.net/k221033/ 2022-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k221033-uniprime-a-uniprime-e-uniprime-ec-fda-510k.jpg K221033 - UniPrime A, UniPrime E, UniPrime E/C K221033 is a FDA 510(k) cleared dental medical device. Manufacturer: S&C Polymer Silicon- Und Composite Spezialit?ten GmbH. Cleared Jul 2022. https://www.510kdatabase.net/k221173/ 2022-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k221173-surgical-mask-model-0868f-0866f-fda-510k.jpg K221173 - Surgical Mask (Model: 0868F, 0866F) K221173 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangxi Sanhao Medical Instruments Co.,Ltd. Cleared Jul 2022. https://www.510kdatabase.net/k221426/ 2022-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k221426-functional-mr-v10-fda-510k.jpg K221426 - Functional MR V1.0 K221426 is a FDA 510(k) cleared radiology medical device. Manufacturer: Olea Medical S.A.S.. Cleared Jul 2022. https://www.510kdatabase.net/k213360/ 2022-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k213360-sleepcheckrx-fda-510k.jpg K213360 - SleepCheckRx K213360 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Resapp Health. Cleared Jul 2022. https://www.510kdatabase.net/k220743/ 2022-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k220743-ceditec-fda-510k.jpg K220743 - CediTEC K220743 is a FDA 510(k) cleared dental medical device. Manufacturer: Voco GmbH. Cleared Jul 2022. https://www.510kdatabase.net/k220827/ 2022-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k220827-electric-wheelchair-fda-510k.jpg K220827 - Electric Wheelchair K220827 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Foshan Dahao Medical Technology Co., Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k221019/ 2022-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k221019-osteon-precision-milled-suprastructure-fda-510k.jpg K221019 - Osteon Precision Milled Suprastructure K221019 is a FDA 510(k) cleared dental medical device. Manufacturer: Implant Solutions Pty Ltd (Aka Osteon Medical). Cleared Jul 2022. https://www.510kdatabase.net/k221337/ 2022-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k221337-materialise-tka-guide-system-fda-510k.jpg K221337 - Materialise TKA Guide System K221337 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Materialise NV. Cleared Jul 2022. https://www.510kdatabase.net/k203134/ 2022-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k203134-hanger-cranial-band-3d-fda-510k.jpg K203134 - Hanger Cranial Band 3D K203134 is a FDA 510(k) cleared neurology medical device. Manufacturer: Symbion Logistics, LLC. Cleared Jul 2022. https://www.510kdatabase.net/k211085/ 2022-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k211085-bd-perisafe-tuohy-epidural-needle-bd-fda-510k.jpg K211085 - BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle K211085 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Becton, Dickinson and Company. Cleared Jul 2022. https://www.510kdatabase.net/k211150/ 2022-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k211150-dental-diode-laser-soga-laser-ilaser-ii-fda-510k.jpg K211150 - Dental diode laser, SOGA Laser, ILaser II K211150 is a FDA 510(k) cleared dental medical device. Manufacturer: Shenzhen Soga Technology Co., Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k211176/ 2022-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k211176-smith-nephew-hip-systems-fda-510k.jpg K211176 - Smith & Nephew Hip Systems K211176 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k213232/ 2022-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k213232-novacore-semi-automatic-biopsy-fda-510k.jpg K213232 - NovaCore Semi-Automatic Biopsy Instrument K213232 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Argon Medical Devices. Cleared Jul 2022. https://www.510kdatabase.net/k213315/ 2022-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k213315-crosslead-peripheral-guide-wire-fda-510k.jpg K213315 - CROSSLEAD Peripheral Guide Wire K213315 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Asahi Intecc Co., Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k213385/ 2022-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k213385-gem-fda-510k.jpg K213385 - GEM K213385 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Obsidio, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k213488/ 2022-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k213488-bladder-scanner-model-namem5-fda-510k.jpg K213488 - Bladder Scanner, Model Name:M5 K213488 is a FDA 510(k) cleared radiology medical device. Manufacturer: Suzhou Peaksonic Medical Technology Co., Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k213521/ 2022-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k213521-nihon-kohden-nkv-330-ventilator-system-fda-510k.jpg K213521 - Nihon Kohden NKV-330 Ventilator System K213521 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Nihon Kohden Orangemed, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k213871/ 2022-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k213871-ennovate-cervical-spinal-and-occiput-fda-510k.jpg K213871 - Ennovate Cervical Spinal and Occiput System K213871 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aesculap Implant Systems, LLC. Cleared Jul 2022. https://www.510kdatabase.net/k214050/ 2022-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k214050-ent-nasopharyngoscope-and-accessories-fda-510k.jpg K214050 - ENT Nasopharyngoscope and Accessories K214050 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Medimaging Integrated Solution, Inc (Miis). Cleared Jul 2022. https://www.510kdatabase.net/k220171/ 2022-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k220171-nes-reprocessed-09mm-turbo-elite-laser-fda-510k.jpg K220171 - NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter K220171 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Northeast Scientific, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k220248/ 2022-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k220248-home-use-hair-removal-device-fda-510k.jpg K220248 - Home use hair removal device K220248 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Mareal Tech Co., Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k220298/ 2022-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k220298-cerrozone-mobile-fda-510k.jpg K220298 - CerroZone Mobile K220298 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cerrozone. Cleared Jul 2022. https://www.510kdatabase.net/k220317/ 2022-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k220317-puraply-micronized-wound-matrix-fda-510k.jpg K220317 - PuraPly Micronized Wound Matrix (PuraPly MZ) K220317 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Organogenesis, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k220500/ 2022-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k220500-ergoline-vitality-total-light-3-planet-fda-510k.jpg K220500 - Ergoline Vitality Total Light 3, Planet Fitness 50/4 TLT by Ergoline, Planet Fitness 42/3 TLT by Ergoline, Ergoline Vitality Hybrid Light 3, Ergoline Vitality Hybrid Light, Planet Fitness 50/4 HLT by Ergoline, Planet Fitness 46/3 HLT by Ergoline, Ergoline Vitality Pure Light 3, Ergoline Vitality Pure Light, Planet Fitness 50/4 PLT III by Ergoline, Planet Fitness 50/4 PLT by Ergoline, Planet Fitness 46/3 PLT by Ergoline, Planet Fitness 42/3 PLT by Ergoline K220500 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Jk Holding GmbH. Cleared Jul 2022. https://www.510kdatabase.net/k220660/ 2022-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k220660-prevena-restor-adapti-form-dressing-fda-510k.jpg K220660 - Prevena Restor Adapti-Form Dressing K220660 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3M Healthcare Business Group. Cleared Jul 2022. https://www.510kdatabase.net/k220784/ 2022-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k220784-acqmap-high-resolution-imaging-and-fda-510k.jpg K220784 - AcQMap High Resolution Imaging and Mapping System K220784 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Acutus Medical, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k221025/ 2022-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k221025-i-field-15t-superconducting-magnetic-fda-510k.jpg K221025 - i_ Field 1.5T Superconducting Magnetic Resonance Imaging System K221025 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mri Division,Beijing Wandong Medical Technology Co., Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k221026/ 2022-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k221026-power-wheelchair-fda-510k.jpg K221026 - Power Wheelchair K221026 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zhejiang Innuovo Rehabilitation Devices Co.,Ltd. Cleared Jul 2022. https://www.510kdatabase.net/k221036/ 2022-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k221036-astroglide-warming-fda-510k.jpg K221036 - Astroglide Warming K221036 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Biofilm, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k221176/ 2022-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k221176-insulin-pen-needle-fda-510k.jpg K221176 - Insulin Pen Needle K221176 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Tianjin Huahong Technology Co., Ltd.. Cleared Jul 2022. https://www.510kdatabase.net/k221395/ 2022-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k221395-footmotion-plating-system-fda-510k.jpg K221395 - Footmotion Plating System K221395 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Newclip Technics. Cleared Jul 2022. https://www.510kdatabase.net/k221625/ 2022-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k221625-2-way-100-silicone-cleartract-catheter-fda-510k.jpg K221625 - 2-Way 100% Silicone ClearTract Catheter K221625 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Silq Technologies Corporation. Cleared Jul 2022. https://www.510kdatabase.net/k221909/ 2022-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k221909-j-temp-fda-510k.jpg K221909 - J-Temp K221909 is a FDA 510(k) cleared dental medical device. Manufacturer: Ultradent Products, Inc.. Cleared Jul 2022. https://www.510kdatabase.net/k203597/ 2022-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k203597-cholesterol2-fda-510k.jpg K203597 - Cholesterol2 K203597 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Ireland Diagnostics Division. Cleared Jun 2022. https://www.510kdatabase.net/k212418/ 2022-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k212418-hcg-one-step-pregnancy-test-fda-510k.jpg K212418 - hCG One Step Pregnancy Test K212418 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Healstone Biotech, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k212785/ 2022-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k212785-blue-sky-bio-multi-one-implant-system-fda-510k.jpg K212785 - Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments K212785 is a FDA 510(k) cleared dental medical device. Manufacturer: Blue Sky Bio, LLC. Cleared Jun 2022. https://www.510kdatabase.net/k213582/ 2022-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k213582-epicardial-access-system-fda-510k.jpg K213582 - Epicardial Access System K213582 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baylis Medical Company, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k213913/ 2022-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k213913-leva-pelvic-health-system-fda-510k.jpg K213913 - leva Pelvic Health System K213913 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Renovia, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k213949/ 2022-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k213949-vassallo-gt-018-floppy-fda-510k.jpg K213949 - VASSALLO GT 018 Floppy K213949 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Filmecc Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k220378/ 2022-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k220378-sparta-3-ply-surgical-disposable-face-fda-510k.jpg K220378 - Sparta 3-Ply Surgical Disposable Face Mask K220378 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sparta East, LLC. Cleared Jun 2022. https://www.510kdatabase.net/k220634/ 2022-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k220634-nc-trek-neo-coronary-dilatation-catheter-fda-510k.jpg K220634 - NC TREK NEO Coronary Dilatation Catheter K220634 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Vascular. Cleared Jun 2022. https://www.510kdatabase.net/k220651/ 2022-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k220651-wrist-type-blood-pressure-monitor-fda-510k.jpg K220651 - Wrist Type Blood Pressure Monitor K220651 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Jamr Medical Technology Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k221050/ 2022-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k221050-zespin-si-joint-fusion-system-paeon-fda-510k.jpg K221050 - ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior Cervical Plate System, Spinema Lumbar Plate System K221050 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aegis Spine, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k221569/ 2022-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k221569-intense-pulsed-light-ipl-system-model-fda-510k.jpg K221569 - Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K K221569 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Fansizhe Science And Technology Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k221571/ 2022-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k221571-inmode-multi-system-fda-510k.jpg K221571 - InMode Multi-system K221571 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Inmode , Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k221750/ 2022-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k221750-cps-aim-universal-ii-slittable-inner-fda-510k.jpg K221750 - CPS AIM Universal II Slittable Inner Catheter K221750 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared Jun 2022. https://www.510kdatabase.net/k211016/ 2022-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k211016-powered-breast-pump-models-7v-and-7x-fda-510k.jpg K211016 - Powered Breast Pump (Models 7V and 7X) K211016 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Haenim Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k213231/ 2022-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k213231-kerecis-silicone-fda-510k.jpg K213231 - Kerecis Silicone K213231 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Kerecis Limited. Cleared Jun 2022. https://www.510kdatabase.net/k213794/ 2022-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k213794-eko-murmur-analysis-software-emas-fda-510k.jpg K213794 - Eko Murmur Analysis Software (EMAS) K213794 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Eko Devices, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k220017/ 2022-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k220017-coloring-liquid-fda-510k.jpg K220017 - Coloring Liquid K220017 is a FDA 510(k) cleared dental medical device. Manufacturer: Dongguan Xiangtong Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k220289/ 2022-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k220289-fridamom-anti-nausea-bands-fda-510k.jpg K220289 - FridaMom Anti-Nausea Bands K220289 is a FDA 510(k) cleared neurology medical device. Manufacturer: Fridababy, LLC. Cleared Jun 2022. https://www.510kdatabase.net/k220409/ 2022-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k220409-artis-pheno-ve21-system-fda-510k.jpg K220409 - ARTIS pheno (VE21) System K220409 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k220410/ 2022-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k220410-ebony-hp-pta-otw-0035-catheter-fda-510k.jpg K220410 - Ebony HP PTA OTW 0.035 Catheter K220410 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Natec Medical , Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k220432/ 2022-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k220432-artis-icono-ve21-system-fda-510k.jpg K220432 - ARTIS icono (VE21) System K220432 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k220544/ 2022-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k220544-dabra-excimer-laser-system-dabra-laser-fda-510k.jpg K220544 - DABRA Excimer Laser System (DABRA Laser model RA-308 and DABRA Catheter model 2.0) K220544 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ra Medical Systems,Inc. Cleared Jun 2022. https://www.510kdatabase.net/k220834/ 2022-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k220834-powder-free-nitrile-examination-glove-fda-510k.jpg K220834 - Powder Free Nitrile Examination Glove K220834 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Daxwell, LLC. Cleared Jun 2022. https://www.510kdatabase.net/k220934/ 2022-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k220934-radifocus-torque-device-fda-510k.jpg K220934 - RADIFOCUS Torque Device K220934 is a FDA 510(k) cleared neurology medical device. Manufacturer: Terumo Medical Products Hangzhou Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k220937/ 2022-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k220937-arthrex-mini-fragment-system-fda-510k.jpg K220937 - Arthrex Mini Fragment System K220937 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k220960/ 2022-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k220960-bruxzir-opaque-coloring-liquid-fda-510k.jpg K220960 - BruxZir Opaque Coloring Liquid K220960 is a FDA 510(k) cleared dental medical device. Manufacturer: Prismatik Dentalcraft, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k220975/ 2022-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k220975-v8-diagnostic-ultrasound-system-v7-fda-510k.jpg K220975 - V8 Diagnostic Ultrasound System, V7 Diagnostic Ultrasound System K220975 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Medison Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k221286/ 2022-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k221286-clarox-fda-510k.jpg K221286 - CLAROX K221286 is a FDA 510(k) cleared radiology medical device. Manufacturer: Vsi Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k221312/ 2022-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k221312-diode-laser-hair-removal-device-fda-510k.jpg K221312 - Diode Laser Hair Removal Device K221312 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Guangzhou Chuang Zao Mei Technology Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k221611/ 2022-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k221611-780-nm-l11-led-light-source-with-aim-fda-510k.jpg K221611 - 780 nm L11 LED Light Source with AIM K221611 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker. Cleared Jun 2022. https://www.510kdatabase.net/k221714/ 2022-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k221714-flat-panel-detector-fda-510k.jpg K221714 - Flat Panel Detector K221714 is a FDA 510(k) cleared radiology medical device. Manufacturer: Iray Technology Taicang , Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k211076/ 2022-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k211076-patient-specific-marking-guides-fda-510k.jpg K211076 - Patient Specific Marking Guides K211076 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Additive Orthopaedics, LLC. Cleared Jun 2022. https://www.510kdatabase.net/k211705/ 2022-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k211705-3m-attest-rapid-readout-biological-fda-510k.jpg K211705 - 3M Attest Rapid Readout Biological Indicator, 1295 K211705 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Jun 2022. https://www.510kdatabase.net/k211718/ 2022-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k211718-venus-cervical-plate-system-fda-510k.jpg K211718 - Venus Cervical Plate System K211718 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Artfx Medical, LLC. Cleared Jun 2022. https://www.510kdatabase.net/k213478/ 2022-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k213478-bd-pen-needle-fda-510k.jpg K213478 - BD Pen Needle K213478 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson and Company. Cleared Jun 2022. https://www.510kdatabase.net/k213577/ 2022-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k213577-venair-sequential-compression-system-fda-510k.jpg K213577 - VenAir, Sequential Compression System K213577 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Apex Medical Corp.. Cleared Jun 2022. https://www.510kdatabase.net/k213726/ 2022-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k213726-pl-1-skin-treatment-system-fda-510k.jpg K213726 - PL-1 Skin Treatment System K213726 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Avava, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k220447/ 2022-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k220447-med-link-disposable-ecg-cable-and-fda-510k.jpg K220447 - Med-link Disposable ECG Cable and Leadwires K220447 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Med-Link Electronics Tech Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k220449/ 2022-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k220449-depuy-conduit-llif-squid-inserter-fda-510k.jpg K220449 - DePuy CONDUIT LLIF SQUID Inserter K220449 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Enztec Limited. Cleared Jun 2022. https://www.510kdatabase.net/k220670/ 2022-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k220670-magnum-fda-510k.jpg K220670 - Magnum K220670 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Magnum Health and Safety Pvt, Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k221195/ 2022-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k221195-osteoprobe-fda-510k.jpg K221195 - OsteoProbe K221195 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Active Life Scientific, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k221256/ 2022-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k221256-mg-osteoinject-fda-510k.jpg K221256 - Mg OSTEOINJECT K221256 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Bone Solutions, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k221272/ 2022-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k221272-medical-face-mask-fda-510k.jpg K221272 - Medical Face Mask K221272 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shandong Xingyu Gloves Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k221273/ 2022-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k221273-medical-face-mask-m001-fda-510k.jpg K221273 - Medical Face Mask (M001) K221273 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Xingyu Medical Tech Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k210947/ 2022-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k210947-navident-fda-510k.jpg K210947 - Navident K210947 is a FDA 510(k) cleared dental medical device. Manufacturer: Claronav, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k213786/ 2022-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k213786-cirx-single-use-electrosurgical-pencil-fda-510k.jpg K213786 - CiRX Single use electrosurgical pencil with non-coated and coated electrode K213786 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ningbo Shun YE Medical Company, Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k213818/ 2022-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k213818-versaone-optical-trocar-with-fixation-fda-510k.jpg K213818 - VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula K213818 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien. Cleared Jun 2022. https://www.510kdatabase.net/k220309/ 2022-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k220309-wearable-breast-pump-model-s10-fda-510k.jpg K220309 - Wearable Breast Pump (Model S10) K220309 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shenzhen Lutejiacheng Technology Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k220790/ 2022-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k220790-disposable-polypectomy-snare-fda-510k.jpg K220790 - Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare K220790 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Yangzhou Fartley Medical Instrument Technology Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k220848/ 2022-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k220848-venue-fit-fda-510k.jpg K220848 - Venue Fit K220848 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Jun 2022. https://www.510kdatabase.net/k220851/ 2022-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k220851-venue-fda-510k.jpg K220851 - Venue K220851 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Jun 2022. https://www.510kdatabase.net/k221233/ 2022-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k221233-dt-703-fda-510k.jpg K221233 - DT-703 K221233 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ecotron Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k200715/ 2022-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k200715-roughrider-aurora-manual-wheelchair-fda-510k.jpg K200715 - RoughRider Aurora Manual Wheelchair K200715 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Roughrider America, LLC. Cleared Jun 2022. https://www.510kdatabase.net/k210852/ 2022-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k210852-noris-medical-dental-implants-system-fda-510k.jpg K210852 - Noris Medical Dental Implants System - Cortical K210852 is a FDA 510(k) cleared dental medical device. Manufacturer: Noris Medical , Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k212043/ 2022-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k212043-traus-endo-fda-510k.jpg K212043 - TRAUS ENDO K212043 is a FDA 510(k) cleared dental medical device. Manufacturer: Saeshin Precision Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k212741/ 2022-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k212741-ezypor-fda-510k.jpg K212741 - EZYPOR K212741 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Fci (France Chirurgie Instrumentation) Sas. Cleared Jun 2022. https://www.510kdatabase.net/k213114/ 2022-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k213114-bentriotm-allergy-blocker-fda-510k.jpg K213114 - BentrioTM Allergy Blocker K213114 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Altamira Therapeutics, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k213250/ 2022-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k213250-secret-duo-fda-510k.jpg K213250 - Secret Duo K213250 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ilooda Co,., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k213439/ 2022-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k213439-flexboardtm-eagleboardtm-breastboard-fda-510k.jpg K213439 - FlexBoardTM, EagleBoardTM, BreastBoard SXTM K213439 is a FDA 510(k) cleared radiology medical device. Manufacturer: Macromedics BV. Cleared Jun 2022. https://www.510kdatabase.net/k213789/ 2022-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k213789-intelligence-lasercomb-fda-510k.jpg K213789 - Intelligence LaserComb K213789 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Yibin Yingtong Intelligent Technology Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k214123/ 2022-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k214123-t-fix-3dsi-joint-fusion-system-fda-510k.jpg K214123 - T-FIX® 3DSI Joint Fusion System K214123 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Cutting Edge Spine, LLC. Cleared Jun 2022. https://www.510kdatabase.net/k220300/ 2022-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k220300-otoplan-fda-510k.jpg K220300 - OTOPLAN K220300 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Cascination AG. Cleared Jun 2022. https://www.510kdatabase.net/k220377/ 2022-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k220377-procedure-mask-fda-510k.jpg K220377 - Procedure Mask K220377 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Little Rapids Corporation. Cleared Jun 2022. https://www.510kdatabase.net/k220575/ 2022-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k220575-magnetom-freemax-magnetom-freestar-fda-510k.jpg K220575 - MAGNETOM Free.Max, MAGNETOM Free.Star K220575 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k220801/ 2022-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k220801-id-now-instrument-id-now-influenza-a-b-fda-510k.jpg K220801 - ID Now Instrument, ID Now Influenza A & B 2, ID NOW Strep A 2 K220801 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Diagnostics Scarborough, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k220942/ 2022-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k220942-3m-attest-steam-chemical-integrators-fda-510k.jpg K220942 - 3M Attest Steam Chemical Integrators (1243A, 1243B, 1243RE, 1243RES) K220942 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Jun 2022. https://www.510kdatabase.net/k221524/ 2022-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k221524-sugita-avm-microclip-applier-fda-510k.jpg K221524 - Sugita AVM Microclip Applier K221524 is a FDA 510(k) cleared neurology medical device. Manufacturer: Mizuho America, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k221834/ 2022-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k221834-non-variola-orthopoxvirus-real-time-fda-510k.jpg K221834 - Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set K221834 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Centers For Disease Control and Prevention. Cleared Jun 2022. https://www.510kdatabase.net/k201788/ 2022-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k201788-eden-spinal-fixation-system-fda-510k.jpg K201788 - EDEN Spinal Fixation System K201788 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Jmt Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k211173/ 2022-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k211173-maxmorespine-bipolar-electrodes-fda-510k.jpg K211173 - maxmorespine Bipolar Electrodes K211173 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Hoogland Spine Products, GmbH. Cleared Jun 2022. https://www.510kdatabase.net/k213194/ 2022-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k213194-hd-mediastinoscope-fda-510k.jpg K213194 - HD Mediastinoscope K213194 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k213233/ 2022-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k213233-ezypro-ecg-recorder-model-ug02-fda-510k.jpg K213233 - EZYPRO ECG Recorder (Model: UG02) K213233 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sigknow Biomedical Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k213338/ 2022-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k213338-core-clip-fda-510k.jpg K213338 - CORE-CLIP K213338 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Incore Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k213349/ 2022-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k213349-catalyst-r1-reverse-shoulder-system-fda-510k.jpg K213349 - Catalyst R1 Reverse Shoulder System K213349 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Catalyst Orthoscience, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k213612/ 2022-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k213612-sylfirm-x-fda-510k.jpg K213612 - SYLFIRM X K213612 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: VIOL Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k220494/ 2022-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k220494-breathid-hp-lab-system-breathid-smart-fda-510k.jpg K220494 - BreathID Hp Lab System, BreathID Smart System K220494 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Meridian Bioscience Israel , Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k220497/ 2022-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k220497-columbo-fda-510k.jpg K220497 - CoLumbo K220497 is a FDA 510(k) cleared radiology medical device. Manufacturer: Smart Soft Healthcare AD. Cleared Jun 2022. https://www.510kdatabase.net/k220514/ 2022-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k220514-bite-away-neo-fda-510k.jpg K220514 - bite away neo K220514 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: mibeTec GmbH. Cleared Jun 2022. https://www.510kdatabase.net/k220732/ 2022-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k220732-mural-perinatal-surveillance-fda-510k.jpg K220732 - Mural Perinatal Surveillance K220732 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ge Medical Systems Information Technologies, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k220756/ 2022-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k220756-introcan-safety-2-iv-catheter-fda-510k.jpg K220756 - Introcan Safety 2 IV Catheter K220756 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k220993/ 2022-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k220993-ultrasound-system-sonimage-mx1-fda-510k.jpg K220993 - Ultrasound System SONIMAGE MX1 K220993 is a FDA 510(k) cleared radiology medical device. Manufacturer: Konica Minolta, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k221188/ 2022-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k221188-zepto-precision-capsulotomy-system-fda-510k.jpg K221188 - ZEPTO Precision Capsulotomy System K221188 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Centricity Vision, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k221204/ 2022-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k221204-excipio-sv-thrombectomy-device-fda-510k.jpg K221204 - Excipio SV Thrombectomy Device K221204 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Contego Medical, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k221511/ 2022-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k221511-axial3d-cloud-segmentation-service-fda-510k.jpg K221511 - Axial3D Cloud Segmentation Service K221511 is a FDA 510(k) cleared radiology medical device. Manufacturer: Axial Medical Printing Limited. Cleared Jun 2022. https://www.510kdatabase.net/k211877/ 2022-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k211877-klassic-knee-system-fda-510k.jpg K211877 - Klassic Knee System K211877 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Total Joint Orthopedics, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k212665/ 2022-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k212665-pulse-oximeter-model-number-so611-fda-510k.jpg K212665 - Pulse Oximeter (Model Number-SO611), Pulse Oximeter (Model Number- S0711), Pulse Oximeter (S0811), Pulse Oximeter (S0911) K212665 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Huizhou Xiaoou Technology Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k213230/ 2022-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k213230-t3-platform-software-fda-510k.jpg K213230 - T3 Platform Software K213230 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Etiometry, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k213274/ 2022-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k213274-qlicksmart-bladeflask-universal-fda-510k.jpg K213274 - Qlicksmart BladeFlask UNIVERSAL K213274 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Qlicksmart Pty , Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k213283/ 2022-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k213283-gentlecath-air-for-men-hydrophilic-fda-510k.jpg K213283 - GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter K213283 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Convatec Limited. Cleared Jun 2022. https://www.510kdatabase.net/k213345/ 2022-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k213345-sentiero-audx-audx-pro-sentiero-fda-510k.jpg K213345 - Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE K213345 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Path Medical GmbH. Cleared Jun 2022. https://www.510kdatabase.net/k213682/ 2022-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k213682-hemosphere-advanced-monitor-hemosphere-fda-510k.jpg K213682 - HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable, HemoSphere Pressure Cable, HemoSphere ClearSight Module, HemoSphere Technology Module, HemoSphere ForeSight Oximeter Cable, Acumen Hypotension Prediction Index Feature, Acumen Assisted Fluid Management Feature, Viewfinder Remote K213682 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Jun 2022. https://www.510kdatabase.net/k213739/ 2022-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k213739-nitrile-examination-gloves-fda-510k.jpg K213739 - Nitrile Examination Gloves K213739 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hangzhou Runheng Medical Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k213765/ 2022-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k213765-glidewell-3dp-denture-base-resin-fda-510k.jpg K213765 - Glidewell 3DP Denture Base Resin K213765 is a FDA 510(k) cleared dental medical device. Manufacturer: Prismatik Dentalcraft, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k220413/ 2022-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k220413-canary-tibial-extension-cte-with-fda-510k.jpg K220413 - Canary Tibial Extension (CTE) with Canary Health Implanted Reporting Processor (CHIRP) System K220413 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Canary Medical USA, LLC. Cleared Jun 2022. https://www.510kdatabase.net/k220586/ 2022-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k220586-symbotex-composite-mesh-progrip-self-fda-510k.jpg K220586 - Symbotex Composite Mesh, ProGrip Self-Gripping Polyester Mesh, Parietex Hydrophilic 2D 3D Anatomical Mesh, Versatex Monofilament Mesh K220586 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sofradim Production. Cleared Jun 2022. https://www.510kdatabase.net/k221008/ 2022-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k221008-hdr-sensor-hdr361-size-1-hdr-sensor-fda-510k.jpg K221008 - HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2) K221008 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai Handy Medical Equipment Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k221185/ 2022-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k221185-tc-gloves-fda-510k.jpg K221185 - TC Gloves K221185 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Thanh Cong Pharmaceutical and Trading Company Limited. Cleared Jun 2022. https://www.510kdatabase.net/k221192/ 2022-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k221192-disposable-nitrile-powder-free-fda-510k.jpg K221192 - Disposable Nitrile Powder-Free Examination Gloves K221192 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shandong Maida Medical Technology Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k221482/ 2022-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k221482-esophageal-tts-stent-fda-510k.jpg K221482 - Esophageal TTS Stent K221482 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Taewoong Medical Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k203791/ 2022-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k203791-stainless-turbine-fda-510k.jpg K203791 - Stainless Turbine K203791 is a FDA 510(k) cleared dental medical device. Manufacturer: Nakanishi, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k210766/ 2022-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k210766-acqmap-3d-imaging-and-mapping-catheter-fda-510k.jpg K210766 - AcQMap 3D Imaging and Mapping Catheter, Model 900009 K210766 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Acutus Medical, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k211148/ 2022-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k211148-core-trocar-fda-510k.jpg K211148 - CORE-Trocar K211148 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Incore Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k211979/ 2022-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k211979-lumenis-yr-laser-system-fda-510k.jpg K211979 - Lumenis Y&R Laser System K211979 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lumenis, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k213220/ 2022-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k213220-revaree-plus-vaginal-suppositories-fda-510k.jpg K213220 - Revaree Plus Vaginal Suppositories K213220 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Farma-Derma S.R.L.. Cleared Jun 2022. https://www.510kdatabase.net/k213665/ 2022-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k213665-syngo-carbon-space-va20a-fda-510k.jpg K213665 - Syngo Carbon Space VA20A K213665 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Healthcare GmbH. Cleared Jun 2022. https://www.510kdatabase.net/k220270/ 2022-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k220270-aspirex-thrombectomy-system-fda-510k.jpg K220270 - Aspirex Thrombectomy System K220270 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k220478/ 2022-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k220478-nuvasive-mod-ex-xlif-interbody-system-fda-510k.jpg K220478 - NuVasive MOD-EX XLIF Interbody System, NuVasive MOD-EX XLIF Plated 2.0 Interbody System K220478 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Jun 2022. https://www.510kdatabase.net/k220482/ 2022-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k220482-sherlock-fda-510k.jpg K220482 - Sherlock K220482 is a FDA 510(k) cleared dental medical device. Manufacturer: Open Implants, LLC. Cleared Jun 2022. https://www.510kdatabase.net/k220800/ 2022-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k220800-venue-go-fda-510k.jpg K220800 - Venue Go K220800 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared Jun 2022. https://www.510kdatabase.net/k220856/ 2022-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k220856-vial-adapter-13mm-fda-510k.jpg K220856 - Vial Adapter Ø13mm K220856 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Avenir Performance Europ?enne Medical (Apem). Cleared Jun 2022. https://www.510kdatabase.net/k213228/ 2022-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k213228-neuroline-disposable-cranial-fda-510k.jpg K213228 - NeuroLine Disposable Cranial Perforator with Hudson end K213228 is a FDA 510(k) cleared neurology medical device. Manufacturer: Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft.. Cleared Jun 2022. https://www.510kdatabase.net/k211099/ 2022-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k211099-freezen-clear-skin-clinic-warts-tags-fda-510k.jpg K211099 - Freeze’n Clear Skin Clinic Warts & Tags K211099 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cryoconcepts LP. Cleared Jun 2022. https://www.510kdatabase.net/k212871/ 2022-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k212871-aliyatm-system-aliyatm-generator-fda-510k.jpg K212871 - Aliya(TM) System, Aliya(TM) Generator, Aliya(TM) Needle, Aliya(TM) Electrode K212871 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Galvanize Therapeutics, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k213037/ 2022-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k213037-idx-dr-v23-fda-510k.jpg K213037 - IDx-DR v2.3 K213037 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Digital Diagnostics, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k213197/ 2022-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k213197-myonyx-system-fda-510k.jpg K213197 - MyOnyx System K213197 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Thought Technology , Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k213255/ 2022-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k213255-cipherox-cri-tablet-fda-510k.jpg K213255 - CipherOx CRI Tablet K213255 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Flashback Technologies, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k220210/ 2022-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k220210-disposable-endoscopy-adapter-set-fda-510k.jpg K220210 - Disposable Endoscopy Adapter Set K220210 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Yangzhou Fartley Medical Instrument Technology Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k220431/ 2022-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k220431-blue-nitrile-powder-free-patient-fda-510k.jpg K220431 - Blue Nitrile Powder-Free Patient Examination Glove, Non-Sterile K220431 is a FDA 510(k) cleared general hospital medical device. Manufacturer: One Glove Industrial Sdn Bhd. Cleared Jun 2022. https://www.510kdatabase.net/k220523/ 2022-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k220523-restor3d-tidal-lumbar-interbody-fusion-fda-510k.jpg K220523 - restor3d TiDAL Lumbar Interbody Fusion Device K220523 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Restor3d. Cleared Jun 2022. https://www.510kdatabase.net/k220572/ 2022-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k220572-ceragem-automatic-thermal-massager-fda-510k.jpg K220572 - Ceragem Automatic Thermal Massager, Model CGM MB-1701 & CGM MB-1702 K220572 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Ceragem Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k220813/ 2022-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k220813-art-plan-fda-510k.jpg K220813 - ART-PLAN K220813 is a FDA 510(k) cleared radiology medical device. Manufacturer: Therapanacea. Cleared Jun 2022. https://www.510kdatabase.net/k221117/ 2022-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k221117-rs85-diagnostic-ultrasound-system-rs80-fda-510k.jpg K221117 - RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System K221117 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Medison Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k221217/ 2022-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k221217-spy-laparoscope-fda-510k.jpg K221217 - SPY Laparoscope K221217 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker. Cleared Jun 2022. https://www.510kdatabase.net/k221408/ 2022-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k221408-aria-radiation-therapy-management-v161-fda-510k.jpg K221408 - ARIA Radiation Therapy Management (v16.1 MR3) K221408 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k221463/ 2022-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k221463-elucidvivo-a3-fda-510k.jpg K221463 - ElucidVivo A.3 K221463 is a FDA 510(k) cleared radiology medical device. Manufacturer: Elucid Bioimaging, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k221465/ 2022-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k221465-baby-gorillagorilla-plating-system-fda-510k.jpg K221465 - Baby Gorilla/Gorilla Plating System K221465 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paragon 28, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k221470/ 2022-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k221470-langston-dual-lumen-catheter-fda-510k.jpg K221470 - Langston dual lumen catheter K221470 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vascular Solutions, LLC. Cleared Jun 2022. https://www.510kdatabase.net/den210004/ 2022-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/den210004-zuno-smart-sterilization-container-fda-510k.jpg DEN210004 - Zuno Smart Sterilization Container DEN210004 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zuno Medical, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k201037/ 2022-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k201037-fora-advanced-gd40-glucose-ketone-and-fda-510k.jpg K201037 - FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System K201037 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Taidoc Technology Corporation. Cleared Jun 2022. https://www.510kdatabase.net/k201348/ 2022-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k201348-depuy-3d-additive-triflange-acetabular-fda-510k.jpg K201348 - DePuy 3D Additive TriFlange Acetabular Cup K201348 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy International, Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k203624/ 2022-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k203624-custom-made-invisible-aligners-fda-510k.jpg K203624 - Custom-made Invisible Aligners K203624 is a FDA 510(k) cleared dental medical device. Manufacturer: Zhejiang Yinchili Medical Technology Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k212426/ 2022-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k212426-dewin-reproductive-media-dewin-fda-510k.jpg K212426 - Dewin Reproductive Media (Dewin Fertilization Medium [with HSA and without HSA] and Dewin Cleavage Medium [with HSA and without HSA]) K212426 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Donnevie Medical Technology (Shanghai) Co. , Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k212788/ 2022-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k212788-seer-home-fda-510k.jpg K212788 - Seer Home K212788 is a FDA 510(k) cleared neurology medical device. Manufacturer: Seer Medical Pty, Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k212870/ 2022-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k212870-tlc-unicompartmental-knee-system-fda-510k.jpg K212870 - TLC Unicompartmental Knee System K212870 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Signature Orthopaedics Pty, Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k213504/ 2022-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k213504-aquilion-one-tsx-306a3-v1012-with-fda-510k.jpg K213504 - Aquilion ONE (TSX-306A/3) V10.12 with Spectral Imaging System, Vitrea Software Package, VSTP-001A K213504 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Jun 2022. https://www.510kdatabase.net/k220299/ 2022-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k220299-ion-endoluminal-system-if1000-fda-510k.jpg K220299 - Ion Endoluminal System (IF1000) K220299 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k220399/ 2022-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k220399-wiscope-digital-bronchoscope-system-fda-510k.jpg K220399 - WiScope Digital Bronchoscope System, WiScope Single-Use Digital Flexible Bronchoscope, WiScope Image System K220399 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: OTU Medical, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k220440/ 2022-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k220440-dentis-s-clean-abutment-mini-fda-510k.jpg K220440 - Dentis s-Clean Abutment Mini K220440 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentis Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k220469/ 2022-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k220469-disposable-vinyl-examination-glove-fda-510k.jpg K220469 - Disposable Vinyl Examination Glove K220469 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Chifeng Huawei Medical Science&Technology Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k220878/ 2022-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k220878-straumann-tlx-variobase-c-fda-510k.jpg K220878 - Straumann TLX Variobase C K220878 is a FDA 510(k) cleared dental medical device. Manufacturer: Institut Straumann AG. Cleared Jun 2022. https://www.510kdatabase.net/k221186/ 2022-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k221186-tc-gloves-fda-510k.jpg K221186 - TC Gloves K221186 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Thanh Cong Pharmaceutical and Trading Company Limited. Cleared Jun 2022. https://www.510kdatabase.net/k221226/ 2022-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k221226-1st-glove-blue-nitrile-examination-fda-510k.jpg K221226 - 1st Glove Blue Nitrile Examination Gloves Powder Free K221226 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Koove Iot Pvt. , Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k221345/ 2022-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k221345-wireless-digital-flat-panel-detector-fda-510k.jpg K221345 - Wireless Digital Flat Panel Detector K221345 is a FDA 510(k) cleared radiology medical device. Manufacturer: Iray Technology Taicang , Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k212325/ 2022-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k212325-eeg-acp-fda-510k.jpg K212325 - EEG-acp K212325 is a FDA 510(k) cleared neurology medical device. Manufacturer: Somnomedics GmbH. Cleared Jun 2022. https://www.510kdatabase.net/k213088/ 2022-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k213088-zquiet-advance-fda-510k.jpg K213088 - ZQuiet Advance K213088 is a FDA 510(k) cleared dental medical device. Manufacturer: Sleeping Well, LLC. Cleared Jun 2022. https://www.510kdatabase.net/k213626/ 2022-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k213626-vitros-afp-fda-510k.jpg K213626 - VITROS AFP K213626 is a FDA 510(k) cleared immunology medical device. Manufacturer: Ortho-Clinical Diagnostics. Cleared Jun 2022. https://www.510kdatabase.net/k213684/ 2022-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k213684-surgicase-viewer-fda-510k.jpg K213684 - SurgiCase Viewer K213684 is a FDA 510(k) cleared radiology medical device. Manufacturer: Materialise NV. Cleared Jun 2022. https://www.510kdatabase.net/k220106/ 2022-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k220106-qardioarm-2-fda-510k.jpg K220106 - QardioArm 2 K220106 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Qardio, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k220614/ 2022-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k220614-medoject-fine-pen-needles-fda-510k.jpg K220614 - MEDOJECT fine Pen Needles K220614 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Chirana T. Injecta. Cleared Jun 2022. https://www.510kdatabase.net/k220804/ 2022-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k220804-dia-x-bond-universal-fda-510k.jpg K220804 - Dia-X Bond Universal K220804 is a FDA 510(k) cleared dental medical device. Manufacturer: DiaDent Group International. Cleared Jun 2022. https://www.510kdatabase.net/k221448/ 2022-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k221448-aria-radiation-therapy-management-v158-fda-510k.jpg K221448 - ARIA Radiation Therapy Management (v15.8), Eclipse Treatment Planning System (v15.8) K221448 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k211466/ 2022-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k211466-yomi-robotic-system-with-yomiplan-go-fda-510k.jpg K211466 - Yomi Robotic System with YomiPlan Go K211466 is a FDA 510(k) cleared dental medical device. Manufacturer: Neocis, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k212808/ 2022-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k212808-logic-hd-camera-head-green-system-green-fda-510k.jpg K212808 - Logic Hd camera head green, System green K212808 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Richard Wolf Medical Instruments Corporation. Cleared Jun 2022. https://www.510kdatabase.net/k213467/ 2022-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k213467-eva-nexus-ophthalmic-surgical-system-fda-510k.jpg K213467 - EVA NEXUS Ophthalmic Surgical System K213467 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: D.O.R.C. Dutch Ophthalmic Research Center (International). Cleared Jun 2022. https://www.510kdatabase.net/k220004/ 2022-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k220004-zsquare-ent-flex-endoscope-fda-510k.jpg K220004 - Zsquare ENT-Flex Endoscope K220004 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Zsquare, Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k220550/ 2022-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k220550-disposable-surgical-face-mask-m663be-fda-510k.jpg K220550 - Disposable Surgical Face Mask (M663BE, M663BT) K220550 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Makrite Industries, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k221386/ 2022-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k221386-perf-gen-pulsatile-perfusion-solution-fda-510k.jpg K221386 - PERF-GEN Pulsatile Perfusion Solution K221386 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Institut Georges Lopez. Cleared Jun 2022. https://www.510kdatabase.net/k221387/ 2022-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k221387-bel-gen-cold-storage-solution-fda-510k.jpg K221387 - BEL-GEN Cold Storage Solution K221387 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Institut Georges Lopez. Cleared Jun 2022. https://www.510kdatabase.net/k221500/ 2022-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k221500-acuson-sequoia-diagnostic-ultrasound-fda-510k.jpg K221500 - ACUSON Sequoia Diagnostic Ultrasound System K221500 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k221620/ 2022-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k221620-digital-radiography-cxdi-elite-digital-fda-510k.jpg K221620 - Digital Radiography CXDI-Elite, Digital Radiography E1 K221620 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k220157/ 2022-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k220157-disposable-hemostatic-closure-clip-fda-510k.jpg K220157 - Disposable Hemostatic Closure Clip Device K220157 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Micro-Tech (Nanjing) Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k221081/ 2022-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k221081-iqflex-m-mobile-x-ray-system-iqflex-md-fda-510k.jpg K221081 - iQFlex M Mobile X-ray System, iQFlex MD Mobile X-ray System K221081 is a FDA 510(k) cleared radiology medical device. Manufacturer: First Source, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k221695/ 2022-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k221695-3m-filtek-supreme-flowable-restorative-fda-510k.jpg K221695 - 3M Filtek Supreme Flowable Restorative K221695 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company Espe Dental Products. Cleared Jun 2022. https://www.510kdatabase.net/den220006/ 2022-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/den220006-prodigi-fda-510k.jpg DEN220006 - ProdiGI DEN220006 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Covidien, LLC. Cleared Jun 2022. https://www.510kdatabase.net/k203208/ 2022-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k203208-guardian-angel-rx-ga2000-series-fda-510k.jpg K203208 - Guardian Angel Rx GA2000 Series Digital Vital Sign Monitoring System K203208 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Taiwan Aulisa Medical Devices Technologies, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k221384/ 2022-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k221384-heating-tensems-device-ft-240-1-fda-510k.jpg K221384 - Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2 K221384 is a FDA 510(k) cleared neurology medical device. Manufacturer: Hivox Biotek, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k203757/ 2022-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k203757-elecsys-amh-fda-510k.jpg K203757 - Elecsys AMH K203757 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Jun 2022. https://www.510kdatabase.net/k210582/ 2022-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k210582-easyclip-and-easyclip-xpress-fda-510k.jpg K210582 - EasyClip® and EasyClip® Xpress K210582 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker GmbH. Cleared Jun 2022. https://www.510kdatabase.net/k212024/ 2022-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k212024-pal-system-fda-510k.jpg K212024 - PAL System K212024 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Microaire Surgical Instruments, LLC. Cleared Jun 2022. https://www.510kdatabase.net/k213097/ 2022-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k213097-armory-motion-fda-510k.jpg K213097 - Armory Motion K213097 is a FDA 510(k) cleared neurology medical device. Manufacturer: Pain Management Technologies, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k213442/ 2022-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k213442-extroducer-infusion-catheter-system-fda-510k.jpg K213442 - Extroducer Infusion Catheter System K213442 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: SmartWise Sweden AB. Cleared Jun 2022. https://www.510kdatabase.net/k213515/ 2022-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k213515-wespero2-fda-510k.jpg K213515 - WesperO2 K213515 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Wesper, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k213519/ 2022-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k213519-rune-labs-tremor-transducer-system-fda-510k.jpg K213519 - Rune Labs Tremor Transducer System K213519 is a FDA 510(k) cleared neurology medical device. Manufacturer: Rune Labs, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k213667/ 2022-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k213667-ifuse-torq-implant-system-fda-510k.jpg K213667 - iFuse-TORQ® Implant System K213667 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SI-BONE, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k220060/ 2022-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k220060-pre-filled-syringe-with-saline-fda-510k.jpg K220060 - Pre-filled Syringe with Saline K220060 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Caina Medical Co.,Ltd. Cleared Jun 2022. https://www.510kdatabase.net/k220319/ 2022-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k220319-asnis-iii-cannulated-screw-system-fda-510k.jpg K220319 - Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System K220319 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker GmbH. Cleared Jun 2022. https://www.510kdatabase.net/k220420/ 2022-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k220420-saffron-fixation-system-fda-510k.jpg K220420 - Saffron Fixation System K220420 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Coloplast A/S. Cleared Jun 2022. https://www.510kdatabase.net/k220528/ 2022-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k220528-surgical-isolation-cover-gown-fda-510k.jpg K220528 - Surgical Isolation Cover Gown K220528 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wuhan Dymex Healthcare Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k220796/ 2022-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k220796-intellamap-orion-high-resolution-fda-510k.jpg K220796 - IntellaMap Orion High Resolution Mapping Catheter K220796 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Jun 2022. https://www.510kdatabase.net/k220894/ 2022-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k220894-smileguard-fda-510k.jpg K220894 - SmileGuard K220894 is a FDA 510(k) cleared dental medical device. Manufacturer: Envisiontec GmbH. Cleared Jun 2022. https://www.510kdatabase.net/k221065/ 2022-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k221065-medilab-fda-510k.jpg K221065 - MediLab K221065 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sigma Scientific Services, LLC. Cleared Jun 2022. https://www.510kdatabase.net/k221087/ 2022-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k221087-synergy-cranial-v229-stealthstation-fda-510k.jpg K221087 - Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4 K221087 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Navigation, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k221362/ 2022-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k221362-omni-foot-and-ankle-plating-system-fda-510k.jpg K221362 - Omni Foot and Ankle Plating System K221362 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exremity Medical, LLC. Cleared Jun 2022. https://www.510kdatabase.net/k221376/ 2022-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k221376-nalu-neurostimulation-system-fda-510k.jpg K221376 - Nalu Neurostimulation System K221376 is a FDA 510(k) cleared neurology medical device. Manufacturer: Boston Scientific Neuromodulation. Cleared Jun 2022. https://www.510kdatabase.net/k221393/ 2022-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k221393-swoop-portable-mr-imaging-system-fda-510k.jpg K221393 - Swoop Portable MR Imaging System K221393 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hyperfine, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k221658/ 2022-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k221658-non-variola-orthopoxvirus-real-time-fda-510k.jpg K221658 - Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set K221658 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Centers For Disease Control and Prevention. Cleared Jun 2022. https://www.510kdatabase.net/k211000/ 2022-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k211000-acutron-fda-510k.jpg K211000 - ACUTRON K211000 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ilooda Co,., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k211909/ 2022-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k211909-cysto-gastro-sets-fda-510k.jpg K211909 - Cysto-Gastro-Sets K211909 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: G-Flex Europe Sprl. Cleared Jun 2022. https://www.510kdatabase.net/k211981/ 2022-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k211981-kheiron-spinal-fixation-system-fda-510k.jpg K211981 - KHEIRON® Spinal Fixation System K211981 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: S.M.A.I.O. Cleared Jun 2022. https://www.510kdatabase.net/k212663/ 2022-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k212663-helios-iv-785-fda-510k.jpg K212663 - HELIOS IV 785 K212663 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Laseroptek Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k213258/ 2022-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k213258-nasogastric-feeding-tubes-enfit-port-pvc-fda-510k.jpg K213258 - Nasogastric Feeding Tubes - ENFit Port - PVC K213258 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cair Lgl. Cleared Jun 2022. https://www.510kdatabase.net/k213587/ 2022-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k213587-mycro-band-fda-510k.jpg K213587 - MyCRO Band K213587 is a FDA 510(k) cleared neurology medical device. Manufacturer: Otto Bock Healthcare LP. Cleared Jun 2022. https://www.510kdatabase.net/k220259/ 2022-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k220259-ally-adaptive-cataract-treatment-system-fda-510k.jpg K220259 - ALLY Adaptive Cataract Treatment System K220259 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Lensar, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k220717/ 2022-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k220717-redpoint-medicals-better-bunion-system-fda-510k.jpg K220717 - RedPoint Medical's Better Bunion System K220717 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Redpoint Medical, LLC. Cleared Jun 2022. https://www.510kdatabase.net/k220729/ 2022-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k220729-the-luminance-red-acne-device-fda-510k.jpg K220729 - The Luminance RED Acne Device K220729 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Luminance Medical Ventures, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k220782/ 2022-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k220782-identiti-porous-ti-interbody-system-fda-510k.jpg K220782 - IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™ PEEK Interbody System, Transcend™ NanoTec™ Interbody System, IdentiTi™ ALIF Standalone Interbody System, IdentiTi™ NanoTec™ ALIF Standalone Interbody System, IdentiTi™ Cervical Standalone Interbody System, IdentiTi™ NanoTec™ Cervical Standalone Interbody System K220782 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k220988/ 2022-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k220988-eksonr-fda-510k.jpg K220988 - EksoNR K220988 is a FDA 510(k) cleared neurology medical device. Manufacturer: Ekso Bionics, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k221071/ 2022-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k221071-niti-s-biliary-slim-m-stent-fda-510k.jpg K221071 - Niti-S Biliary Slim M Stent K221071 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Taewoong Medical Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k221077/ 2022-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k221077-auryon-atherectomy-system-fda-510k.jpg K221077 - Auryon Atherectomy System K221077 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Eximo Medical, Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k221339/ 2022-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k221339-paladin-carotid-post-dilation-balloon-fda-510k.jpg K221339 - Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection K221339 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Contego Medical, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k221368/ 2022-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k221368-promisemed-blood-lancet-verifine-fda-510k.jpg K221368 - Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet K221368 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Promisemed Hangzhou Meditech Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k212933/ 2022-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k212933-inhancetm-hybrid-anatomic-glenoid-fda-510k.jpg K212933 - INHANCETM Hybrid Anatomic Glenoid Implant K212933 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Ireland UC. Cleared Jun 2022. https://www.510kdatabase.net/k213173/ 2022-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k213173-trabex-pro-fda-510k.jpg K213173 - TrabEx Pro K213173 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Microsurgical Technologies, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k213185/ 2022-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k213185-imajin-silicone-double-loop-ureteral-fda-510k.jpg K213185 - ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kits K213185 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Coloplast Corp.. Cleared Jun 2022. https://www.510kdatabase.net/k213717/ 2022-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k213717-air-recon-dl-fda-510k.jpg K213717 - AIR Recon DL K213717 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems,Llc (Ge Healthcare). Cleared Jun 2022. https://www.510kdatabase.net/k213862/ 2022-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k213862-hd60-series-ultrasound-diagnostic-system-fda-510k.jpg K213862 - HD60 Series Ultrasound Diagnostic System K213862 is a FDA 510(k) cleared radiology medical device. Manufacturer: Qingdao Hisense Medical Equipment Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k213882/ 2022-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k213882-earlipoint-system-fda-510k.jpg K213882 - EarliPoint System K213882 is a FDA 510(k) cleared neurology medical device. Manufacturer: Earlitec Diagnostics, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k221371/ 2022-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k221371-promisemed-heel-blood-lancet-fda-510k.jpg K221371 - Promisemed Heel Blood Lancet K221371 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Promisemed Hangzhou Meditech Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k221389/ 2022-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k221389-fairfix-am-adjustable-button-fairfix-fda-510k.jpg K221389 - FairFix AM Adjustable Button FairFix PSP Adjustable Button K221389 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Jun 2022. https://www.510kdatabase.net/k203579/ 2022-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k203579-infinity-gateway-suite-fda-510k.jpg K203579 - Infinity Gateway Suite K203579 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Draeger Medical Systems, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k210804/ 2022-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k210804-adhese-universal-dc-cention-primer-fda-510k.jpg K210804 - Adhese Universal DC, Cention Primer K210804 is a FDA 510(k) cleared dental medical device. Manufacturer: Ivoclar Vivadent, AG. Cleared Jun 2022. https://www.510kdatabase.net/k213087/ 2022-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k213087-natural-rubber-latex-ultrasound-fda-510k.jpg K213087 - Natural Rubber Latex Ultrasound Transducer Probe Covers K213087 is a FDA 510(k) cleared radiology medical device. Manufacturer: Global Protection Corp.. Cleared Jun 2022. https://www.510kdatabase.net/k213117/ 2022-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k213117-fx-v135-shoulder-prosthesis-fda-510k.jpg K213117 - FX V135 Shoulder Prosthesis K213117 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Fx Shoulder USA, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k220455/ 2022-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k220455-lap-band-system-calibration-tube-fda-510k.jpg K220455 - Lap-Band System Calibration Tube K220455 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Reshape Lifesciences. Cleared Jun 2022. https://www.510kdatabase.net/k220693/ 2022-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k220693-zoupure-nitrile-powder-free-fda-510k.jpg K220693 - Zoupure Nitrile Powder Free Examination glove K220693 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Thai Rayong Product Glove Zoupure Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k221160/ 2022-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k221160-xpert-xpress-mvp-genexpert-dx-system-fda-510k.jpg K221160 - Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System K221160 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Cepheid. Cleared Jun 2022. https://www.510kdatabase.net/k221335/ 2022-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k221335-drs-and-drs-9090-fda-510k.jpg K221335 - D²RS and D²RS 9090 K221335 is a FDA 510(k) cleared radiology medical device. Manufacturer: Stephanix. Cleared Jun 2022. https://www.510kdatabase.net/k221438/ 2022-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k221438-whill-model-f-fda-510k.jpg K221438 - WHILL Model F K221438 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Whill, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k211207/ 2022-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k211207-diacare-7000-fda-510k.jpg K211207 - Diacare 7000 K211207 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Globus Sport and Health Technologies, LLC. Cleared Jun 2022. https://www.510kdatabase.net/k212450/ 2022-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k212450-keos-anterior-cervical-interbody-fda-510k.jpg K212450 - Keos Anterior Cervical Interbody Fusion Device System K212450 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Keos. Cleared Jun 2022. https://www.510kdatabase.net/k213222/ 2022-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k213222-disposable-polypectomy-snare-fda-510k.jpg K213222 - Disposable Polypectomy Snare K213222 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Beijing Zksk Technology Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k213223/ 2022-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k213223-multi-band-ligator-fda-510k.jpg K213223 - Multi-Band Ligator K213223 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Beijing Zksk Technology Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k213448/ 2022-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k213448-powder-free-nitrile-gloves-fda-510k.jpg K213448 - Powder Free Nitrile Gloves K213448 is a FDA 510(k) cleared general hospital medical device. Manufacturer: St Future International Limited. Cleared Jun 2022. https://www.510kdatabase.net/k220358/ 2022-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k220358-voluson-expert-22-voluson-expert-20-fda-510k.jpg K220358 - Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 K220358 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared Jun 2022. https://www.510kdatabase.net/k220612/ 2022-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k220612-primeloc-attachment-system-fda-510k.jpg K220612 - PrimeLOC Attachment System K220612 is a FDA 510(k) cleared dental medical device. Manufacturer: Innovative Product Brands, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k220947/ 2022-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k220947-arthrex-knotless-ac-repair-devices-fda-510k.jpg K220947 - Arthrex Knotless AC Repair Devices K220947 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k221222/ 2022-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k221222-surgical-face-mask-hnfm0304-fda-510k.jpg K221222 - Surgical Face Mask (HNFM0304) K221222 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shanghai Hua EN Industrial Co, Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k221231/ 2022-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k221231-drug-relief-v1-fda-510k.jpg K221231 - Drug Relief v1 K221231 is a FDA 510(k) cleared neurology medical device. Manufacturer: Dyansys, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k221366/ 2022-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k221366-smart-correction-system-rings-and-fda-510k.jpg K221366 - Smart Correction System Rings and Compatible HA-Coated Half Pins K221366 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wishbone Medical, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k213846/ 2022-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k213846-q2-blood-administration-sets-fda-510k.jpg K213846 - Q2 Blood Administration Sets K213846 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Quest Medical, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k210084/ 2022-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k210084-silkro-fda-510k.jpg K210084 - SILKRO K210084 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Hironic Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k210371/ 2022-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k210371-portable-oxygen-concentrator-model-p2-e6-fda-510k.jpg K210371 - Portable Oxygen Concentrator, model: P2-E6 K210371 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Qingdao Kingon Medical Science and Technology Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k210741/ 2022-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k210741-kls-martin-neuro-rongeurs-fda-510k.jpg K210741 - KLS Martin Neuro Rongeurs K210741 is a FDA 510(k) cleared neurology medical device. Manufacturer: KLS-Martin L.P.. Cleared Jun 2022. https://www.510kdatabase.net/k211046/ 2022-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k211046-ecaremanager-45-fda-510k.jpg K211046 - eCareManager 4.5 K211046 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Visicu, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k211567/ 2022-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k211567-bimobile-instruments-for-bimobile-dual-fda-510k.jpg K211567 - BiMobile Instruments (for BiMobile Dual Mobility System) K211567 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Waldemar Link GmbH & Co. KG. Cleared Jun 2022. https://www.510kdatabase.net/k213332/ 2022-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k213332-multifrax-laser-system-fda-510k.jpg K213332 - Multifrax Laser System K213332 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Paradigm Medical Corporation. Cleared Jun 2022. https://www.510kdatabase.net/k213924/ 2022-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k213924-gastric-alimetry-system-fda-510k.jpg K213924 - Gastric Alimetry System K213924 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Alimetry , Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k213931/ 2022-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k213931-vitek-2-ast-gram-negative-omadacycline-fda-510k.jpg K213931 - VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL) K213931 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k213971/ 2022-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k213971-atrial-fibrillation-history-feature-fda-510k.jpg K213971 - Atrial Fibrillation History Feature K213971 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Apple, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k213977/ 2022-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k213977-truebeam-truebeam-stx-edge-vitalbeam-fda-510k.jpg K213977 - TrueBeam, TrueBeam STx, Edge, VitalBeam K213977 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k213988/ 2022-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k213988-soft-plug-extended-duration-180-fda-510k.jpg K213988 - SOFT PLUG Extended Duration 180 Tapered Canalicular Plug K213988 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Oasis Medical, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k214063/ 2022-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k214063-model-121-biopsy-needle-model-111-fda-510k.jpg K214063 - Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle K214063 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Guangzhou Shengwei Medical Devices Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k214089/ 2022-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k214089-fujifilm-ultrasonic-processor-sp-900-fda-510k.jpg K214089 - FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2 K214089 is a FDA 510(k) cleared radiology medical device. Manufacturer: Fujifilm Corporation. Cleared Jun 2022. https://www.510kdatabase.net/k220205/ 2022-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k220205-3d-anatomic-models-fda-510k.jpg K220205 - 3D Anatomic Models K220205 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ricoh USA, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k220321/ 2022-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k220321-aptima-combo-2-assay-250-test-kit-fda-510k.jpg K220321 - Aptima Combo 2 Assay (250 test kit) Panther, Aptima Combo 2 Assay (250 test kit) Tigris, Aptima Trichomonas Vaginalis Assay (250 test kit) Panther, Aptima Trichomonas Vaginalis Assay (250 test kit) Tigris K220321 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Hologic, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k220633/ 2022-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k220633-microlet-next-lancing-device-microlet-fda-510k.jpg K220633 - MICROLET NEXT lancing device, MICROLET Lancet K220633 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ascensia Diabetes Care U.S., Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k220652/ 2022-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k220652-knee-3-fda-510k.jpg K220652 - Knee 3 K220652 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Brainlab AG. Cleared Jun 2022. https://www.510kdatabase.net/k220665/ 2022-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k220665-surgical-gown-blue-sterile-fda-510k.jpg K220665 - Surgical Gown, Blue, Sterile K220665 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Excellent Medical Technology Group Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k220672/ 2022-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k220672-blue-powder-free-nitrile-examination-fda-510k.jpg K220672 - Blue Powder Free Nitrile Examination Glove with Grape Scented, Chemotherapy Drugs and Fentanyl Test Claim K220672 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Riverstone Resources Sdn Bhd. Cleared Jun 2022. https://www.510kdatabase.net/k220761/ 2022-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k220761-circul8-connect-dvt-prevention-device-fda-510k.jpg K220761 - CIRCUL8 Connect DVT Prevention Device K220761 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ortho8, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k221061/ 2022-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k221061-21hq613d-fda-510k.jpg K221061 - 21HQ613D K221061 is a FDA 510(k) cleared radiology medical device. Manufacturer: Lg Electronics.Inc. Cleared Jun 2022. https://www.510kdatabase.net/k221314/ 2022-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k221314-briefcase-fda-510k.jpg K221314 - BriefCase K221314 is a FDA 510(k) cleared radiology medical device. Manufacturer: Aidoc Medical , Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k200754/ 2022-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k200754-hemosure-accu-reader-a100-fda-510k.jpg K200754 - Hemosure Accu-Reader A100 K200754 is a FDA 510(k) cleared hematology medical device. Manufacturer: W.H.P.M., Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k210758/ 2022-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k210758-q-patch-fda-510k.jpg K210758 - Q Patch K210758 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medicalgorithmics S.A.. Cleared Jun 2022. https://www.510kdatabase.net/k212288/ 2022-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k212288-minjie-catheter-system-fda-510k.jpg K212288 - Minjie Catheter System K212288 is a FDA 510(k) cleared neurology medical device. Manufacturer: Kai Medtech, LLC. Cleared Jun 2022. https://www.510kdatabase.net/k213239/ 2022-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k213239-endoscopic-injection-needle-fda-510k.jpg K213239 - Endoscopic Injection Needle K213239 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Beijing Zksk Technology Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k213261/ 2022-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k213261-epilme-fda-510k.jpg K213261 - EpilME K213261 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Neauvia North America. Cleared Jun 2022. https://www.510kdatabase.net/k213588/ 2022-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k213588-q2-iv-administration-sets-fda-510k.jpg K213588 - Q2 IV Administration Sets K213588 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Quest Medical, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k214049/ 2022-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k214049-leaseir-mhr-xcell-fda-510k.jpg K214049 - Leaseir MHR Xcell K214049 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Leaseir Technologies, Slu. Cleared Jun 2022. https://www.510kdatabase.net/k220008/ 2022-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k220008-solex-7-intravascular-heat-exchange-fda-510k.jpg K220008 - Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ Console K220008 is a FDA 510(k) cleared neurology medical device. Manufacturer: Zoll Circulation, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k220164/ 2022-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k220164-rayvolve-fda-510k.jpg K220164 - Rayvolve K220164 is a FDA 510(k) cleared radiology medical device. Manufacturer: Azmed Sas. Cleared Jun 2022. https://www.510kdatabase.net/k220541/ 2022-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k220541-purezero-limon-nitrile-powder-free-fda-510k.jpg K220541 - PureZero LIMON Nitrile Powder-Free Exam Gloves, PureZero LIMON-XTRA Nitrile Powder-Free Exam Gloves K220541 is a FDA 510(k) cleared general hospital medical device. Manufacturer: O&M Halyard, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k220547/ 2022-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k220547-purezero-marin-nitrile-powder-free-fda-510k.jpg K220547 - PureZero MARIN Nitrile Powder-Free Exam Gloves, PureZero MARIN-XTRA Nitrile Powder-Free Exam Gloves K220547 is a FDA 510(k) cleared general hospital medical device. Manufacturer: O&M Halyard, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k220581/ 2022-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k220581-zavation-ezspand-interbody-system-fda-510k.jpg K220581 - Zavation eZspand Interbody System K220581 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zavation Medical Products, LLC. Cleared Jun 2022. https://www.510kdatabase.net/k220632/ 2022-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k220632-boss-crossing-support-catheter-fda-510k.jpg K220632 - Boss Crossing Support Catheter K220632 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Marvao Medical Devices, Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k220751/ 2022-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k220751-straumann-blx-temporary-abutment-vita-fda-510k.jpg K220751 - Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA K220751 is a FDA 510(k) cleared dental medical device. Manufacturer: Institut Straumann AG. Cleared Jun 2022. https://www.510kdatabase.net/k220861/ 2022-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k220861-m6-c-artificial-cervical-disc-fda-510k.jpg K220861 - M6-C Artificial Cervical Disc Instruments AS K220861 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinal Kinetics, LLC. Cleared Jun 2022. https://www.510kdatabase.net/k220927/ 2022-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k220927-ipl-hair-removal-fda-510k.jpg K220927 - IPL Hair Removal K220927 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Qiaochengli Technology Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k220930/ 2022-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k220930-restoris-multi-compartmental-knee-system-fda-510k.jpg K220930 - Restoris Multi-Compartmental Knee System K220930 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Mako Surgical Corp.. Cleared Jun 2022. https://www.510kdatabase.net/k203233/ 2022-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k203233-4cis-chiron-spinal-fixation-system-fda-510k.jpg K203233 - 4CIS Chiron Spinal Fixation System K203233 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Solco Biomedical Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k210107/ 2022-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k210107-genadyne-uno-plus-uno-negative-fda-510k.jpg K210107 - Genadyne UNO Plus (UNO+) Negative Pressure Wound Therapy System K210107 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Genadyne Biotechnologies, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k212445/ 2022-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k212445-freeflex-transfer-adapter-fda-510k.jpg K212445 - freeflex+ Transfer Adapter K212445 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Fresenius Kabi AG. Cleared Jun 2022. https://www.510kdatabase.net/k213201/ 2022-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k213201-deltafil-deltafil-conditioner-fda-510k.jpg K213201 - DeltaFil, DeltaFil Conditioner K213201 is a FDA 510(k) cleared dental medical device. Manufacturer: Dmg Chemisch Pharmazeutische Fabrik GmbH. Cleared Jun 2022. https://www.510kdatabase.net/k213753/ 2022-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k213753-purgo-fda-510k.jpg K213753 - Purgo K213753 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Aeroclean Technologies, LLC. Cleared Jun 2022. https://www.510kdatabase.net/k213838/ 2022-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k213838-aneuguide-fda-510k.jpg K213838 - AneuGuide K213838 is a FDA 510(k) cleared neurology medical device. Manufacturer: ArteryFlow Technology Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k220058/ 2022-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k220058-benevision-central-monitoring-system-fda-510k.jpg K220058 - BeneVision Central Monitoring System K220058 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k220488/ 2022-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k220488-disposable-nitrile-powder-free-fda-510k.jpg K220488 - Disposable Nitrile Powder-Free Examination Gloves (Tested for Use with Chemotherapy Drugs) K220488 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k220650/ 2022-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k220650-trimed-ripcord-device-fda-510k.jpg K220650 - TriMed Ripcord Device K220650 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: TriMed, Inc.. Cleared Jun 2022. https://www.510kdatabase.net/k220973/ 2022-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k220973-corelink-navigation-instruments-fda-510k.jpg K220973 - CoreLink Navigation Instruments K220973 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corelink, LLC. Cleared Jun 2022. https://www.510kdatabase.net/k221002/ 2022-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k221002-ipl-hair-removal-device-models-ui04a-fda-510k.jpg K221002 - IPL Hair Removal Device, Model(s): UI04A, UI04B, UI04C K221002 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Ulike Smart Electronics Co., Ltd.. Cleared Jun 2022. https://www.510kdatabase.net/k221264/ 2022-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k221264-frog-forceps-valve-val1-f1-100-fda-510k.jpg K221264 - FROG Forceps Valve (VAL1-F1-100) K221264 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fujifilm Medwork GmbH. Cleared Jun 2022. https://www.510kdatabase.net/k203771/ 2022-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k203771-urea-nitrogen2-fda-510k.jpg K203771 - Urea Nitrogen2 K203771 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Ireland Diagnostics Division. Cleared May 2022. https://www.510kdatabase.net/k210987/ 2022-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k210987-irrigo-wound-wash-jet-system-fda-510k.jpg K210987 - IRRIGO Wound Wash Jet System K210987 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Inopro, Inc.. Cleared May 2022. https://www.510kdatabase.net/k211571/ 2022-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k211571-small-foam-kit-medium-foam-kit-large-fda-510k.jpg K211571 - Small Foam Kit, Medium Foam Kit, Large Foam Kit, Extra Large Foam Kit K211571 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Zhejiang Longterm Medical Technology Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k212680/ 2022-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k212680-luxcreo-clear-aligner-system-fda-510k.jpg K212680 - LuxCreo Clear Aligner System K212680 is a FDA 510(k) cleared dental medical device. Manufacturer: LuxCreo, Inc.. Cleared May 2022. https://www.510kdatabase.net/k212699/ 2022-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k212699-disposable-powder-free-polyethylene-fda-510k.jpg K212699 - Disposable Powder Free Polyethylene Examination Gloves K212699 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Mastermax Plastic (Huizhou), Ltd.. Cleared May 2022. https://www.510kdatabase.net/k212729/ 2022-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k212729-bone-cement-normal-viscosity-fda-510k.jpg K212729 - Bone Cement-Normal Viscosity K212729 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomecanica Industria E Comerciode Produtos Ortopedicos Ltda. Cleared May 2022. https://www.510kdatabase.net/k213065/ 2022-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k213065-distal-access-catheter-fda-510k.jpg K213065 - Distal Access Catheter K213065 is a FDA 510(k) cleared neurology medical device. Manufacturer: Guangzhou Easycess Medical Co.,Ltd. Cleared May 2022. https://www.510kdatabase.net/k213341/ 2022-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k213341-fibrillar-collagen-wound-dressing-fda-510k.jpg K213341 - Fibrillar Collagen Wound Dressing K213341 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Collagen Matrix, Inc.. Cleared May 2022. https://www.510kdatabase.net/k213731/ 2022-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k213731-efai-cardiosuite-spect-myocardial-fda-510k.jpg K213731 - EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows K213731 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ever Fortune.Ai, Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k214096/ 2022-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k214096-respire-clear-fda-510k.jpg K214096 - Respire Clear K214096 is a FDA 510(k) cleared dental medical device. Manufacturer: Respire Medical, LLC. Cleared May 2022. https://www.510kdatabase.net/k220113/ 2022-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k220113-upper-arm-electronic-blood-pressure-fda-510k.jpg K220113 - Upper Arm Electronic Blood Pressure Monitor(Model FC-BP100,FC-BP101,FC-BP102,FC-BP110,FC-BP111,FC-BP112) K220113 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Finicare Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k220766/ 2022-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k220766-emurmur-heart-ai-fda-510k.jpg K220766 - eMurmur Heart AI K220766 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Csd Labs GmbH. Cleared May 2022. https://www.510kdatabase.net/k221248/ 2022-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k221248-rapid-lvo-fda-510k.jpg K221248 - Rapid LVO K221248 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ischemaview, Inc.. Cleared May 2022. https://www.510kdatabase.net/k221270/ 2022-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k221270-echonavigator-r40-fda-510k.jpg K221270 - EchoNavigator R4.0 K221270 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared May 2022. https://www.510kdatabase.net/k221440/ 2022-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k221440-liverty-tips-access-set-fda-510k.jpg K221440 - Liverty™ TIPS Access Set K221440 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bard Peripheral Vascular, Inc.. Cleared May 2022. https://www.510kdatabase.net/k212584/ 2022-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k212584-blue-nitrile-examination-gloves-powder-fda-510k.jpg K212584 - Blue Nitrile Examination Gloves Powder Free K212584 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Amazing Rubber Products Pvt, Ltd.. Cleared May 2022. https://www.510kdatabase.net/k212597/ 2022-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k212597-amazing-latex-examination-powder-free-fda-510k.jpg K212597 - Amazing+ Latex Examination Powder Free Gloves K212597 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Amazing Rubber Products Pvt, Ltd.. Cleared May 2022. https://www.510kdatabase.net/k213141/ 2022-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k213141-biodegradable-powder-free-nitrile-fda-510k.jpg K213141 - Biodegradable Powder Free Nitrile Examination Glove, Blue and Green colors, Low Dermatitis Potential, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate-Simulated Gastric Acid Solution K213141 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shen Wei (Usa), Inc.. Cleared May 2022. https://www.510kdatabase.net/k212268/ 2022-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k212268-fmd-peripheral-guide-wires-f-14-and-f-fda-510k.jpg K212268 - FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT K212268 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: FMD Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k212669/ 2022-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k212669-single-use-hemoclip-fda-510k.jpg K212669 - Single Use Hemoclip K212669 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Zhejiang Chuangxiang Medical Technology Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k212838/ 2022-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k212838-benchmark-intracranial-access-system-fda-510k.jpg K212838 - Benchmark Intracranial Access System K212838 is a FDA 510(k) cleared neurology medical device. Manufacturer: Penumbra, Inc.. Cleared May 2022. https://www.510kdatabase.net/k212873/ 2022-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k212873-aspire-cristalle-fda-510k.jpg K212873 - Aspire Cristalle K212873 is a FDA 510(k) cleared radiology medical device. Manufacturer: Fujifilm Corporation. Cleared May 2022. https://www.510kdatabase.net/k213698/ 2022-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k213698-colink-pcr-plating-system-fda-510k.jpg K213698 - CoLink PCR Plating System K213698 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: In2bones USA, LLC. Cleared May 2022. https://www.510kdatabase.net/k220146/ 2022-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k220146-visar-fda-510k.jpg K220146 - VisAR K220146 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Novarad Corporation. Cleared May 2022. https://www.510kdatabase.net/k220557/ 2022-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k220557-moisturemeterd-compact-lymphscanner-fda-510k.jpg K220557 - MoistureMeterD Compact, LymphScanner K220557 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Delfin Technologies, Ltd.. Cleared May 2022. https://www.510kdatabase.net/k220593/ 2022-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k220593-spine-guidance-software-stryker-q-fda-510k.jpg K220593 - Spine Guidance Software, Stryker Q Guidance System K220593 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Leibinger GmbH & Co KG. Cleared May 2022. https://www.510kdatabase.net/k220609/ 2022-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k220609-powder-free-nitrile-examination-glove-fda-510k.jpg K220609 - Powder-Free Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl (White, Blue, Black, Orange and Green Color) K220609 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Encompass Industries Sdn. Bhd.. Cleared May 2022. https://www.510kdatabase.net/k220610/ 2022-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k220610-solo-l-fda-510k.jpg K220610 - SOLO-L K220610 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aurora Spine, Inc.. Cleared May 2022. https://www.510kdatabase.net/k220889/ 2022-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k220889-senhance-surgical-system-fda-510k.jpg K220889 - Senhance Surgical System K220889 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Asensus Surgical, Inc.. Cleared May 2022. https://www.510kdatabase.net/k220902/ 2022-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k220902-navagio-lumbar-cage-fda-510k.jpg K220902 - Navagio Lumbar Cage K220902 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Kalitec Medical, LLC. Cleared May 2022. https://www.510kdatabase.net/k210633/ 2022-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k210633-amylase2-fda-510k.jpg K210633 - Amylase2 K210633 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Ireland Diagnostics Division. Cleared May 2022. https://www.510kdatabase.net/k211779/ 2022-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k211779-es001-digital-stethoscope-for-general-fda-510k.jpg K211779 - ES001 Digital stethoscope for general-purpose auscultation, ES002 Digital stethoscope for hearing impaired users, ES003 Digital stethoscope for telemedicine. K211779 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Chip Ideas Electronics S.L.. Cleared May 2022. https://www.510kdatabase.net/k212132/ 2022-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k212132-freestyle-libre-3-continuous-glucose-fda-510k.jpg K212132 - FreeStyle Libre 3 Continuous Glucose Monitoring System K212132 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Diabetes Care, Inc.. Cleared May 2022. https://www.510kdatabase.net/k212413/ 2022-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k212413-i-motion-fda-510k.jpg K212413 - I-Motion K212413 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: I-Motion Group Global Iberica S.L.. Cleared May 2022. https://www.510kdatabase.net/k212629/ 2022-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k212629-pp-care-nitrile-examination-gloves-fda-510k.jpg K212629 - PP Care Nitrile Examination Gloves K212629 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Eg Group Product and Services Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k212644/ 2022-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k212644-aura-storm-fda-510k.jpg K212644 - Aura Storm K212644 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Invictus Lighting. Cleared May 2022. https://www.510kdatabase.net/k213027/ 2022-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k213027-laser-hair-growth-comb-fda-510k.jpg K213027 - Laser Hair Growth Comb K213027 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Kam Yuen Plastic Products , Ltd.. Cleared May 2022. https://www.510kdatabase.net/k213171/ 2022-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k213171-aveta-system-aveta-disposable-fda-510k.jpg K213171 - Aveta System, Aveta Disposable Hysteroscope (Pearl/Opal/Coral), Aveta Disposable Cystoscope (Coral) K213171 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Meditrina, Inc.. Cleared May 2022. https://www.510kdatabase.net/k213221/ 2022-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k213221-amadeo-m-uk1015-incl-attachments-and-fda-510k.jpg K213221 - AMADEO, M-UK1015 (incl. attachments and accessories) K213221 is a FDA 510(k) cleared dental medical device. Manufacturer: W&H Dentalwerk Buermoss GmbH. Cleared May 2022. https://www.510kdatabase.net/k213996/ 2022-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k213996-freestyle-libre-3-continuous-glucose-fda-510k.jpg K213996 - FreeStyle Libre 3 Continuous Glucose Monitoring System K213996 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Diabetes Care, Inc.. Cleared May 2022. https://www.510kdatabase.net/k214074/ 2022-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k214074-latex-powder-free-surgical-glove-with-fda-510k.jpg K214074 - Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less per Gram of Glove and Tested for Use with Chemotherapy Drugs K214074 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hartalega NGC Sdn. Bhd.. Cleared May 2022. https://www.510kdatabase.net/k220195/ 2022-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k220195-ifuse-bedrock-granite-implant-system-fda-510k.jpg K220195 - iFuse Bedrock Granite™ Implant System K220195 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SI-BONE, Inc.. Cleared May 2022. https://www.510kdatabase.net/k220249/ 2022-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k220249-sterile-nitrile-powder-free-fda-510k.jpg K220249 - Sterile Nitrile Powder Free Examination Gloves Tested For Use With Chemotherapy Drugs And Fentanyl Citrate (Blue) K220249 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Grand Work Plastic Products Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k220355/ 2022-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k220355-astroglide-ultra-gentle-gel-fda-510k.jpg K220355 - Astroglide Ultra Gentle Gel K220355 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Biofilm, Inc.. Cleared May 2022. https://www.510kdatabase.net/k220545/ 2022-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k220545-powder-free-nitrile-examination-gloves-fda-510k.jpg K220545 - Powder Free Nitrile Examination Gloves, Blue, Tested for use with Chemotherapy Drugs K220545 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hl Rubber Industries Sdn Bhd. Cleared May 2022. https://www.510kdatabase.net/k220596/ 2022-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k220596-wearable-breast-pump-model-s9-fda-510k.jpg K220596 - Wearable Breast Pump (Model S9) K220596 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shenzhen TPH Technology Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k220597/ 2022-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k220597-disposable-surgical-face-mask-fm-fda-510k.jpg K220597 - Disposable Surgical Face Mask (FM-34EE,FM-44EE) K220597 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Qingdao Bestex Rubber & Plastic Products Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k220641/ 2022-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k220641-barrigel-injectable-gel-fda-510k.jpg K220641 - Barrigel Injectable Gel K220641 is a FDA 510(k) cleared radiology medical device. Manufacturer: Palette Life Sciences. Cleared May 2022. https://www.510kdatabase.net/k201393/ 2022-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k201393-restor3d-mtp-implant-fda-510k.jpg K201393 - restor3d MTP Implant K201393 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Restor3D, Inc.. Cleared May 2022. https://www.510kdatabase.net/k202920/ 2022-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k202920-opticomp-fda-510k.jpg K202920 - OptiComp K202920 is a FDA 510(k) cleared dental medical device. Manufacturer: Pac-Dent, Inc.. Cleared May 2022. https://www.510kdatabase.net/k203661/ 2022-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k203661-cryo-arctic-cryo-penguin-fda-510k.jpg K203661 - CRYO Arctic, CRYO Penguin K203661 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Cryoscience North America, Inc.. Cleared May 2022. https://www.510kdatabase.net/k210655/ 2022-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k210655-reprocessed-eagle-eye-platinum-rx-fda-510k.jpg K210655 - Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter K210655 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Innovative Health, LLC. Cleared May 2022. https://www.510kdatabase.net/k210748/ 2022-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k210748-well-life-tm-pen-needles-well-life-tm-fda-510k.jpg K210748 - Well-life TM Pen Needles, Well-life TM Safety Pen Needles K210748 is a FDA 510(k) cleared general hospital medical device. Manufacturer: W. L. Med Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k211652/ 2022-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k211652-renuvion-dermal-handpiece-renuvion-fda-510k.jpg K211652 - Renuvion Dermal Handpiece, Renuvion Dermal System K211652 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Apyx Medical Corporation(Formerly Bovie Medical Corporation). Cleared May 2022. https://www.510kdatabase.net/k211953/ 2022-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k211953-disposable-sterilized-latex-surgical-fda-510k.jpg K211953 - Disposable Sterilized Latex Surgical Gloves K211953 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k213039/ 2022-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k213039-micro-current-facial-cold-and-hot-fda-510k.jpg K213039 - Micro-current facial cold and hot service (model: TPML-100) K213039 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Li-Tek Electronics Technology C0., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k213485/ 2022-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k213485-digital-thermometer-models-aoj-25a-aoj-fda-510k.jpg K213485 - Digital Thermometer, Models: AOJ-25A, AOJ-25B, AOJ-25C, AOJ-25D and AOJ-25E K213485 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen AOJ Medical Technology Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k214046/ 2022-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k214046-780-nm-1688-4k-camera-system-780-nm-fda-510k.jpg K214046 - 780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable K214046 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker. Cleared May 2022. https://www.510kdatabase.net/k220065/ 2022-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k220065-single-use-ureteral-access-sheath-fda-510k.jpg K220065 - Single Use Ureteral Access Sheath K220065 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Zhejiang Chuangxiang Medical Technology Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k220083/ 2022-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k220083-ldvlow-dead-volume-syringe-fda-510k.jpg K220083 - LDV((Low Dead Volume )Syringe K220083 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k220200/ 2022-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k220200-paltop-conical-implant-system-fda-510k.jpg K220200 - Paltop Conical Implant System K220200 is a FDA 510(k) cleared dental medical device. Manufacturer: Paltop Advanced Dental Solutions, Ltd.. Cleared May 2022. https://www.510kdatabase.net/k220350/ 2022-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k220350-kardiamobile-6l-fda-510k.jpg K220350 - KardiaMobile 6L K220350 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: AliveCor, Inc.. Cleared May 2022. https://www.510kdatabase.net/k220416/ 2022-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k220416-swiftmr-fda-510k.jpg K220416 - SwiftMR K220416 is a FDA 510(k) cleared radiology medical device. Manufacturer: Airs Medical, Inc.. Cleared May 2022. https://www.510kdatabase.net/k220481/ 2022-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k220481-remanufactured-ligasure-exact-fda-510k.jpg K220481 - Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019) K220481 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker Sustainability Solutions. Cleared May 2022. https://www.510kdatabase.net/k220578/ 2022-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k220578-transcutaneous-electrical-nerve-fda-510k.jpg K220578 - Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) K220578 is a FDA 510(k) cleared neurology medical device. Manufacturer: Bozhou Rongjian Medical Appliance Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k220793/ 2022-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k220793-innovoyce-laser-fiber-fda-510k.jpg K220793 - InnoVoyce Laser Fiber K220793 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Innovoyce, LLC. Cleared May 2022. https://www.510kdatabase.net/k221180/ 2022-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k221180-anteraligntm-spinal-system-with-titan-fda-510k.jpg K221180 - Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated Instruments K221180 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared May 2022. https://www.510kdatabase.net/k221244/ 2022-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k221244-cd-horizon-spinal-system-fda-510k.jpg K221244 - CD Horizon™ Spinal System K221244 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic. Cleared May 2022. https://www.510kdatabase.net/k210614/ 2022-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k210614-bencox-mirabo-z-cup-cortinium-fda-510k.jpg K210614 - BENCOX Mirabo Z Cup Cortinium K210614 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corentec Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k212327/ 2022-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k212327-m-vizion-monobloc-fda-510k.jpg K212327 - M-Vizion Monobloc K212327 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared May 2022. https://www.510kdatabase.net/k213191/ 2022-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k213191-s-line-fda-510k.jpg K213191 - S-Line K213191 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Barkey GmbH & Co. KG. Cleared May 2022. https://www.510kdatabase.net/k213481/ 2022-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k213481-medline-general-surgery-tray-fda-510k.jpg K213481 - Medline General Surgery Tray K213481 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medline Industries, Inc.. Cleared May 2022. https://www.510kdatabase.net/k213659/ 2022-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k213659-ligapass-20-ligament-augmentation-system-fda-510k.jpg K213659 - LigaPASS™ 2.0 Ligament Augmentation System K213659 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medicrea International SA. Cleared May 2022. https://www.510kdatabase.net/k220191/ 2022-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k220191-disposable-face-mask-fda-510k.jpg K220191 - Disposable Face Mask K220191 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiujiang Taixin Technology Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k220888/ 2022-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k220888-myspine-s2-si-pedicle-and-sacro-iliac-fda-510k.jpg K220888 - MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides K220888 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared May 2022. https://www.510kdatabase.net/k220952/ 2022-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k220952-my01-continuous-compartmental-pressure-fda-510k.jpg K220952 - MY01 Continuous Compartmental Pressure Monitor K220952 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: MY01, Inc.. Cleared May 2022. https://www.510kdatabase.net/k221215/ 2022-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k221215-e-motion-m25-fda-510k.jpg K221215 - e-motion M25 K221215 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Alber GmbH. Cleared May 2022. https://www.510kdatabase.net/den200062/ 2022-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/den200062-parsortix-pc1-device-fda-510k.jpg DEN200062 - Parsortix PC1 Device DEN200062 is a FDA 510(k) cleared medical genetics medical device. Manufacturer: Angle Europe , Ltd.. Cleared May 2022. https://www.510kdatabase.net/k200788/ 2022-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k200788-assure-titanium-blood-glucose-fda-510k.jpg K200788 - Assure Titanium Blood Glucose Monitoring System K200788 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Arkray, Inc.. Cleared May 2022. https://www.510kdatabase.net/k211810/ 2022-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k211810-shamrock-powder-free-blue-nitrile-fda-510k.jpg K211810 - Shamrock Powder Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy Drugs and Fentanyl) K211810 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Pt. Shamrock Manufacturing Corpora. Cleared May 2022. https://www.510kdatabase.net/k211878/ 2022-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k211878-liquiband-xl-fda-510k.jpg K211878 - LiquiBand XL K211878 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Advanced Medical Solutions Limited. Cleared May 2022. https://www.510kdatabase.net/k212563/ 2022-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k212563-calapex-calplus-cerafill-rcs-endoseal-fda-510k.jpg K212563 - CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid K212563 is a FDA 510(k) cleared dental medical device. Manufacturer: Prevest Denpro Limited. Cleared May 2022. https://www.510kdatabase.net/k212803/ 2022-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k212803-dailymate-orthodontic-aligner-system-fda-510k.jpg K212803 - DailyMate Orthodontic Aligner System K212803 is a FDA 510(k) cleared dental medical device. Manufacturer: 3D Global Biotech, Inc.. Cleared May 2022. https://www.510kdatabase.net/k212988/ 2022-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k212988-ono-retrieval-device-fda-510k.jpg K212988 - ONO Retrieval Device K212988 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Onocor Vascular, LLC. Cleared May 2022. https://www.510kdatabase.net/k213402/ 2022-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k213402-triever24-triever20-fda-510k.jpg K213402 - Triever24, Triever20 K213402 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inari Medical. Cleared May 2022. https://www.510kdatabase.net/k213829/ 2022-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k213829-scenaria-view-fda-510k.jpg K213829 - SCENARIA View K213829 is a FDA 510(k) cleared radiology medical device. Manufacturer: Fujifilm Healthcare Corporation. Cleared May 2022. https://www.510kdatabase.net/k220155/ 2022-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k220155-powder-free-nitrile-examination-gloves-fda-510k.jpg K220155 - Powder-free Nitrile Examination Gloves Tested for use with Chemotherapy Drugs K220155 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Motex Healthcare (Anhui) Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k220470/ 2022-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k220470-smart-wireless-stethoscope-fda-510k.jpg K220470 - Smart Wireless Stethoscope K220470 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shanghai Hulu Devices Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k220507/ 2022-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k220507-3m-curos-tamper-evident-device-3m-fda-510k.jpg K220507 - 3M Curos Tamper-Evident Device, 3M Curos Tamper-Evident Device, Large K220507 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared May 2022. https://www.510kdatabase.net/k220532/ 2022-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k220532-disposable-surgical-mask-fda-510k.jpg K220532 - Disposable surgical mask K220532 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Xiamen Blue Star Enterprise Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k220564/ 2022-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k220564-3m-comply-lead-free-steam-indicator-fda-510k.jpg K220564 - 3M Comply Lead Free Steam Indicator Tape 1322, 3M Attest Lead Free Steam Indicator Tape 1355 K220564 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared May 2022. https://www.510kdatabase.net/k220867/ 2022-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k220867-tapestry-biointegrative-implant-fda-510k.jpg K220867 - Tapestry Biointegrative Implant K220867 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Embody, Inc.. Cleared May 2022. https://www.510kdatabase.net/k221000/ 2022-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k221000-on3d-fda-510k.jpg K221000 - ON3D K221000 is a FDA 510(k) cleared radiology medical device. Manufacturer: 3D Ons, Inc.. Cleared May 2022. https://www.510kdatabase.net/k210545/ 2022-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k210545-infrared-red-blue-led-light-heat-fda-510k.jpg K210545 - Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine K210545 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Marci Beauty, Inc.. Cleared May 2022. https://www.510kdatabase.net/k211256/ 2022-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k211256-disposable-sampler-viral-transport-media-fda-510k.jpg K211256 - Disposable Sampler Viral Transport Media K211256 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Wuxi Nest Biotechnology Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k212752/ 2022-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k212752-med-link-pulse-oximeter-fda-510k.jpg K212752 - Med-link Pulse Oximeter K212752 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Med-Link Electronics Tech Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k212979/ 2022-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k212979-calcshift-displacement-calcaneal-fda-510k.jpg K212979 - CalcShift™ Displacement Calcaneal Osteotomy System K212979 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nextremity Solutions, Inc.. Cleared May 2022. https://www.510kdatabase.net/k213540/ 2022-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k213540-quantum-superpac-tubing-set-quantum-fda-510k.jpg K213540 - Quantum SuperPAC Tubing Set, Quantum SuperPAC Cardioplegia Set K213540 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Qura S.R.L. Cleared May 2022. https://www.510kdatabase.net/k220381/ 2022-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k220381-diode-laser-therapy-systems-fda-510k.jpg K220381 - Diode Laser Therapy Systems K220381 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Beijing Lasertell Medical Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k220522/ 2022-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k220522-7d-surgical-system-percutaneous-fda-510k.jpg K220522 - 7D Surgical System - Percutaneous Application (7D Flash Frame) K220522 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 7D Surgical. Cleared May 2022. https://www.510kdatabase.net/k220656/ 2022-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k220656-iovera-system-fda-510k.jpg K220656 - iovera System K220656 is a FDA 510(k) cleared neurology medical device. Manufacturer: Pacira Biosciences, Inc.. Cleared May 2022. https://www.510kdatabase.net/k220832/ 2022-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k220832-syngo-dynamics-version-va40e-fda-510k.jpg K220832 - syngo Dynamics (Version VA40E) K220832 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 2022. https://www.510kdatabase.net/k220838/ 2022-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k220838-artisan-bone-plug-universal-cement-fda-510k.jpg K220838 - Artisan Bone Plug, Universal Cement Restrictor K220838 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics, Dba Stryker Orthopaedics. Cleared May 2022. https://www.510kdatabase.net/k202525/ 2022-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k202525-alinity-i-stat-high-sensitivity-fda-510k.jpg K202525 - Alinity i STAT High Sensitivity Troponin-I K202525 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories Diagnostics Division. Cleared May 2022. https://www.510kdatabase.net/k210596/ 2022-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k210596-architect-toxo-igg-fda-510k.jpg K210596 - ARCHITECT Toxo IgG K210596 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared May 2022. https://www.510kdatabase.net/k210983/ 2022-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k210983-bd-epilor-syringe-fda-510k.jpg K210983 - BD Epilor Syringe K210983 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Becton, Dickinson and Company. Cleared May 2022. https://www.510kdatabase.net/k211534/ 2022-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k211534-revolix-htl-fda-510k.jpg K211534 - RevoLix HTL K211534 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Lisa Laser Products GmbH. Cleared May 2022. https://www.510kdatabase.net/k211869/ 2022-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k211869-ogm-1-polymethylmethacrylate-pmma-bone-fda-510k.jpg K211869 - OGM 1 Polymethylmethacrylate (PMMA) bone cement, OGM 1A Polymethylmethacrylate (PMMA) bone cement K211869 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi VE. Cleared May 2022. https://www.510kdatabase.net/k212565/ 2022-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k212565-coverscan-v1-fda-510k.jpg K212565 - CoverScan v1 K212565 is a FDA 510(k) cleared radiology medical device. Manufacturer: Perspectum, Ltd.. Cleared May 2022. https://www.510kdatabase.net/k213174/ 2022-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k213174-salem-sump-silicone-dual-lumen-stomach-fda-510k.jpg K213174 - Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection K213174 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cardinalhealth. Cleared May 2022. https://www.510kdatabase.net/k213800/ 2022-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k213800-artiglass-nrfittm-tip-lor-glass-syringes-fda-510k.jpg K213800 - Artiglass NRFitTM Tip L.O.R. Glass Syringes K213800 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Artiglass Srl. Cleared May 2022. https://www.510kdatabase.net/k220285/ 2022-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k220285-pine-pedicle-screw-system-fda-510k.jpg K220285 - PINE Pedicle Screw System K220285 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tdm Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k220370/ 2022-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k220370-safety-lancet-xiii-xvii-xxi-xxii-xxiii-fda-510k.jpg K220370 - Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI) K220370 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Tianjin Huahong Technology Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k220392/ 2022-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k220392-papaya-3d-papaya-3d-plus-fda-510k.jpg K220392 - PAPAYA 3D & PAPAYA 3D Plus K220392 is a FDA 510(k) cleared radiology medical device. Manufacturer: Genoray Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k220423/ 2022-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k220423-papaya-papaya-plus-fda-510k.jpg K220423 - PAPAYA & PAPAYA Plus K220423 is a FDA 510(k) cleared radiology medical device. Manufacturer: Genoray Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k220485/ 2022-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k220485-wireless-hand-control-eg1a-wireless-hc-fda-510k.jpg K220485 - Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC) K220485 is a FDA 510(k) cleared neurology medical device. Manufacturer: The Anspach Effort, Inc.. Cleared May 2022. https://www.510kdatabase.net/k220792/ 2022-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k220792-smr-reverse-liner-fda-510k.jpg K220792 - SMR Reverse Liner K220792 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Lima Corporate S.P.A.. Cleared May 2022. https://www.510kdatabase.net/k220824/ 2022-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k220824-medical-surgical-mask-planar-type-fda-510k.jpg K220824 - Medical Surgical Mask (Planar type) K220824 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hunan Chopard Medical Devices Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k220849/ 2022-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k220849-accu-chek-safe-t-pro-plus-lancing-device-fda-510k.jpg K220849 - Accu-Chek Safe-T-Pro Plus Lancing Device K220849 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Roche Diabetes Care, Inc.. Cleared May 2022. https://www.510kdatabase.net/k221134/ 2022-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k221134-procedure-mask-with-ear-loops-and-fda-510k.jpg K221134 - Procedure Mask with Ear Loops and Surgical Mask with Ties K221134 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Safesource Direct, LLC. Cleared May 2022. https://www.510kdatabase.net/k221135/ 2022-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k221135-x-twist-peek-suture-anchor-fda-510k.jpg K221135 - X-Twist PEEK Suture Anchor K221135 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Parcus Medical, LLC. Cleared May 2022. https://www.510kdatabase.net/k221232/ 2022-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k221232-univers-revers-humeral-cup-implant-fda-510k.jpg K221232 - Univers Revers Humeral Cup Implant K221232 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared May 2022. https://www.510kdatabase.net/k212408/ 2022-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k212408-powder-free-nitrile-examination-gloves-fda-510k.jpg K212408 - Powder Free Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs Use and Simulated Gastric Acid) K212408 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Pt. Maja Agung Latexindo. Cleared May 2022. https://www.510kdatabase.net/k212416/ 2022-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k212416-wx-non-automated-blood-pressure-fda-510k.jpg K212416 - WX non-Automated Blood Pressure Meter,MODEL WX02, WX non-Automated Blood Pressure Meter with Stethoscope, MODEL WX0201, WX0202, WX0203 K212416 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Wenzhou Xikang Medical Instruments Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k213840/ 2022-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k213840-moleculight-ix-fda-510k.jpg K213840 - MolecuLight I:X K213840 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Moleculight, Inc.. Cleared May 2022. https://www.510kdatabase.net/k214120/ 2022-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k214120-gss610n21-series-steam-sterilizer-fda-510k.jpg K214120 - GSS610N21 Series Steam Sterilizer K214120 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Maquet GmbH. Cleared May 2022. https://www.510kdatabase.net/k220211/ 2022-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k220211-nitrile-powder-free-examination-gloves-fda-510k.jpg K220211 - Nitrile Powder Free Examination Gloves K220211 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hebei Kangxida Medical Technology Development Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k220218/ 2022-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k220218-siren-sgt-fda-510k.jpg K220218 - Siren SGT K220218 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Tools For Surgery, LLC. Cleared May 2022. https://www.510kdatabase.net/k220333/ 2022-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k220333-medline-orbis-lvl-3-surgical-gown-fda-510k.jpg K220333 - Medline Orbis LVL 3 Surgical Gown K220333 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, LP. Cleared May 2022. https://www.510kdatabase.net/k220463/ 2022-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k220463-osteotomy-truss-system-ots-fda-510k.jpg K220463 - Osteotomy Truss System (OTS) K220463 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 4Web Medical, Inc.. Cleared May 2022. https://www.510kdatabase.net/k220467/ 2022-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k220467-the-family-of-ultrapulse-co2-surgical-fda-510k.jpg K220467 - The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories K220467 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lumenis Be, Ltd.. Cleared May 2022. https://www.510kdatabase.net/k220468/ 2022-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k220468-bencox-mirabo-cup-system-fda-510k.jpg K220468 - BENCOX Mirabo Cup System K220468 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corentec Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k220917/ 2022-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k220917-gentleheel-micro-preemie-gentleheel-fda-510k.jpg K220917 - gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler K220917 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Gri-Alleset, Inc.. Cleared May 2022. https://www.510kdatabase.net/den210046/ 2022-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/den210046-quell-fm-fda-510k.jpg DEN210046 - Quell-FM DEN210046 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neurometrix, Inc.. Cleared May 2022. https://www.510kdatabase.net/k210548/ 2022-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k210548-medline-integrated-arterial-catheter-fda-510k.jpg K210548 - Medline Integrated Arterial Catheter K210548 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Centurion Medical Products. Cleared May 2022. https://www.510kdatabase.net/k211396/ 2022-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k211396-neoss-individual-prosthetics-fda-510k.jpg K211396 - Neoss Individual Prosthetics K211396 is a FDA 510(k) cleared dental medical device. Manufacturer: Neoss, Ltd.. Cleared May 2022. https://www.510kdatabase.net/k212527/ 2022-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k212527-cervical-spine-truss-system-plating-fda-510k.jpg K212527 - Cervical Spine Truss System Plating Solution (CSTS-PS) K212527 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 4Web Medical, Inc.. Cleared May 2022. https://www.510kdatabase.net/k212761/ 2022-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k212761-biocore9-acetabular-cup-system-fda-510k.jpg K212761 - Biocore9 Acetabular Cup System K212761 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biocore9, LLC. Cleared May 2022. https://www.510kdatabase.net/k212782/ 2022-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k212782-sternalock-sternal-closure-system-fda-510k.jpg K212782 - SternaLock Sternal Closure System K212782 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet Microfixation. Cleared May 2022. https://www.510kdatabase.net/k213787/ 2022-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k213787-monaco-rtp-system-fda-510k.jpg K213787 - Monaco RTP System K213787 is a FDA 510(k) cleared radiology medical device. Manufacturer: Elekta Solutions AB. Cleared May 2022. https://www.510kdatabase.net/k220168/ 2022-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k220168-skin-care-beauty-mask-model-mj-06-fda-510k.jpg K220168 - Skin Care Beauty Mask (Model: MJ-06) K220168 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Kaiyan Medical CO , Ltd.. Cleared May 2022. https://www.510kdatabase.net/k220194/ 2022-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k220194-procedure-masksurgical-maskface-mask-fda-510k.jpg K220194 - Procedure mask/Surgical mask/Face mask K220194 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Winner Medical Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k220372/ 2022-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k220372-heel-stick-safety-lancet-hhz-ii-hhz-iii-fda-510k.jpg K220372 - Heel Stick Safety Lancet (HHZ-II, HHZ-III) K220372 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Tianjin Huahong Technology Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k220499/ 2022-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k220499-rapid-pe-triage-and-notification-petn-fda-510k.jpg K220499 - Rapid PE Triage and Notification (PETN) K220499 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ischemaview, Inc.. Cleared May 2022. https://www.510kdatabase.net/k220516/ 2022-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k220516-catalys-precision-laser-system-fda-510k.jpg K220516 - CATALYS Precision Laser system K220516 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Amo Manufacturing USA, LLC. Cleared May 2022. https://www.510kdatabase.net/k220807/ 2022-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k220807-imperative-care-radial-088-access-system-fda-510k.jpg K220807 - Imperative Care Radial 088 Access System K220807 is a FDA 510(k) cleared neurology medical device. Manufacturer: Imperative Care, Inc.. Cleared May 2022. https://www.510kdatabase.net/k220919/ 2022-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k220919-multix-impact-e-fda-510k.jpg K220919 - MULTIX Impact E K220919 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 2022. https://www.510kdatabase.net/k221219/ 2022-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k221219-syngoct-cascoring-fda-510k.jpg K221219 - syngo.CT CaScoring K221219 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 2022. https://www.510kdatabase.net/k221240/ 2022-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k221240-briefcase-fda-510k.jpg K221240 - BriefCase K221240 is a FDA 510(k) cleared radiology medical device. Manufacturer: Aidoc Medical , Ltd.. Cleared May 2022. https://www.510kdatabase.net/den210044/ 2022-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/den210044-cerament-g-fda-510k.jpg DEN210044 - CERAMENT G DEN210044 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Bonesupport AB. Cleared May 2022. https://www.510kdatabase.net/k210516/ 2022-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k210516-clicky-cross-fda-510k.jpg K210516 - Clicky Cross K210516 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Yomura Technologies, Inc.. Cleared May 2022. https://www.510kdatabase.net/k211665/ 2022-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k211665-sonon-ultrasound-imaging-system-model-fda-510k.jpg K211665 - SONON Ultrasound Imaging System, Model: SONON300C K211665 is a FDA 510(k) cleared radiology medical device. Manufacturer: Healcerion Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k212376/ 2022-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k212376-caas-qardia-fda-510k.jpg K212376 - Caas Qardia K212376 is a FDA 510(k) cleared radiology medical device. Manufacturer: Pie Medical Imaging BV. Cleared May 2022. https://www.510kdatabase.net/k213583/ 2022-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k213583-achieva-ingenia-ingenia-cx-ingenia-fda-510k.jpg K213583 - Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems K213583 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared May 2022. https://www.510kdatabase.net/k213832/ 2022-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k213832-aami3-isolation-gown-fda-510k.jpg K213832 - AAMI3 Isolation Gown K213832 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hubei Xinxin Non-Woven Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k220404/ 2022-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k220404-sterrad-nx-with-allclear-technology-fda-510k.jpg K220404 - STERRAD NX with ALLClear Technology K220404 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Advanced Sterilization Products, Inc.. Cleared May 2022. https://www.510kdatabase.net/k220669/ 2022-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k220669-ipl-hair-removal-handset-model-ipl-666-fda-510k.jpg K220669 - IPL HAIR REMOVAL HANDSET, Model: IPL-666 K220669 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Junbobeauty Technology Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k220491/ 2022-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k220491-disposable-medical-nitrile-examination-fda-510k.jpg K220491 - Disposable Medical Nitrile Examination Gloves -Tested for Use with Chemotherapy Drugs K220491 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hainan Asther Medical Equipment Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k220626/ 2022-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k220626-introcan-safety-iv-catheter-fda-510k.jpg K220626 - Introcan Safety IV Catheter K220626 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared May 2022. https://www.510kdatabase.net/k210575/ 2022-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k210575-hdf-assist-mudule-hdf-infusion-set-and-fda-510k.jpg K210575 - HDF Assist Mudule, HDF Infusion Set and Substitution Filter K210575 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Nephros. Cleared May 2022. https://www.510kdatabase.net/k210615/ 2022-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k210615-thompson-brain-retractor-table-mounted-fda-510k.jpg K210615 - Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM) K210615 is a FDA 510(k) cleared neurology medical device. Manufacturer: Thompson Surgical Instruments, Inc.. Cleared May 2022. https://www.510kdatabase.net/k212475/ 2022-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k212475-prevest-denpro-cavity-liners-apacal-fda-510k.jpg K212475 - Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) K212475 is a FDA 510(k) cleared dental medical device. Manufacturer: Prevest Denpro Limited. Cleared May 2022. https://www.510kdatabase.net/k212875/ 2022-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k212875-spectral-ct-on-rails-fda-510k.jpg K212875 - Spectral CT on Rails K212875 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared May 2022. https://www.510kdatabase.net/k213119/ 2022-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k213119-innova-vision-hydrogel-hioxifilcon-a-fda-510k.jpg K213119 - Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens K213119 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Innova Vision, Inc.. Cleared May 2022. https://www.510kdatabase.net/k213137/ 2022-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k213137-intdose-fda-510k.jpg K213137 - INTDose K213137 is a FDA 510(k) cleared radiology medical device. Manufacturer: Carina Medical, LLC. Cleared May 2022. https://www.510kdatabase.net/k213203/ 2022-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k213203-provenatm-midline-catheter-fda-510k.jpg K213203 - Provena(TM) Midline Catheter K213203 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 2022. https://www.510kdatabase.net/k213535/ 2022-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k213535-sterile-safety-hypodermic-needles-for-fda-510k.jpg K213535 - Sterile Safety Hypodermic Needles for Single Use K213535 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zhejiang Kangkang Medical-Devices Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k213785/ 2022-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k213785-smr-tt-hybrid-glenoid-smr-3-pegs-fda-510k.jpg K213785 - SMR TT Hybrid Glenoid, SMR 3-Pegs Cemented Glenoid K213785 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Limacorporate. Cleared May 2022. https://www.510kdatabase.net/k220115/ 2022-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k220115-antares-3dr-standalone-anterior-lumbar-fda-510k.jpg K220115 - ANTARES 3DR Standalone Anterior Lumbar Interbody Fusion System K220115 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: MiRus, LLC. Cleared May 2022. https://www.510kdatabase.net/k220186/ 2022-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k220186-zone-specific-aim-fda-510k.jpg K220186 - Zone Specific AIM K220186 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Conmed Corporation. Cleared May 2022. https://www.510kdatabase.net/k220411/ 2022-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k220411-reprocessed-ligasure-curved-small-jaw-fda-510k.jpg K220411 - Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) K220411 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker Sustainability Solutions. Cleared May 2022. https://www.510kdatabase.net/k220429/ 2022-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k220429-violet-nitrile-powder-free-patient-fda-510k.jpg K220429 - Violet Nitrile Powder-Free Patient Examination Glove, Non Sterile K220429 is a FDA 510(k) cleared general hospital medical device. Manufacturer: One Glove Industrial Sdn Bhd. Cleared May 2022. https://www.510kdatabase.net/k220589/ 2022-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k220589-magnetom-skyra-fit-fda-510k.jpg K220589 - MAGNETOM Skyra Fit K220589 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 2022. https://www.510kdatabase.net/k220749/ 2022-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k220749-surgical-face-mask-model-number-fda-510k.jpg K220749 - Surgical Face Mask, Model Number-17.5X9.5CM EAR-LOOP K220749 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Unimax Medical Products Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k220757/ 2022-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k220757-argo-knotless-sp-anchor-fda-510k.jpg K220757 - Argo Knotless SP Anchor K220757 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Conmed Corporation. Cleared May 2022. https://www.510kdatabase.net/k220760/ 2022-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k220760-pre-formed-penile-silicone-block-fda-510k.jpg K220760 - Pre-Formed Penile Silicone Block K220760 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: International Medical Devices, Inc.. Cleared May 2022. https://www.510kdatabase.net/k221099/ 2022-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k221099-arthrex-self-punching-pushlock-suture-fda-510k.jpg K221099 - Arthrex Self-Punching PushLock Suture Anchor K221099 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared May 2022. https://www.510kdatabase.net/k221106/ 2022-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k221106-quantib-prostate-fda-510k.jpg K221106 - Quantib Prostate K221106 is a FDA 510(k) cleared radiology medical device. Manufacturer: Quantib B.V.. Cleared May 2022. https://www.510kdatabase.net/k221115/ 2022-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k221115-flow-nail-fda-510k.jpg K221115 - Flow-Nail K221115 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Flow-Fx, LLC. Cleared May 2022. https://www.510kdatabase.net/k221116/ 2022-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k221116-xact-ace-robotic-system-fda-510k.jpg K221116 - XACT ACE Robotic System K221116 is a FDA 510(k) cleared radiology medical device. Manufacturer: Xact Robotics, Ltd.. Cleared May 2022. https://www.510kdatabase.net/k221144/ 2022-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k221144-pedra-1417mc-pedra-1417mg-pedra-1417fc-fda-510k.jpg K221144 - PEDRA-1417MC, PEDRA-1417MG, PEDRA-1417FC, PEDRA-1417FG K221144 is a FDA 510(k) cleared radiology medical device. Manufacturer: Radisen Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k221174/ 2022-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k221174-telepack-fda-510k.jpg K221174 - Telepack + K221174 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared May 2022. https://www.510kdatabase.net/k210937/ 2022-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k210937-electronic-thermometer-model-aet-f101-fda-510k.jpg K210937 - Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241 K210937 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Alicn Medical (Shenzhen), Inc.. Cleared May 2022. https://www.510kdatabase.net/k212620/ 2022-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k212620-citrasate-liquid-acid-concentrate-fda-510k.jpg K212620 - Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate K212620 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC. Cleared May 2022. https://www.510kdatabase.net/k213025/ 2022-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k213025-laser-hair-growth-helmet-fda-510k.jpg K213025 - Laser hair growth helmet K213025 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Kam Yuen Plastic Products , Ltd.. Cleared May 2022. https://www.510kdatabase.net/k213491/ 2022-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k213491-universal-pilot-guidance-instrument-fda-510k.jpg K213491 - Universal Pilot Guidance Instrument System K213491 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ctl Medical Corporation. Cleared May 2022. https://www.510kdatabase.net/k213811/ 2022-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k213811-sterile-hypodermic-syringes-for-single-fda-510k.jpg K213811 - Sterile Hypodermic Syringes for Single Use K213811 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Berpu Medical Technology Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k220105/ 2022-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k220105-saige-dx-fda-510k.jpg K220105 - Saige-Dx K220105 is a FDA 510(k) cleared radiology medical device. Manufacturer: DeepHealth, Inc.. Cleared May 2022. https://www.510kdatabase.net/k220118/ 2022-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k220118-nitrile-powder-free-examination-gloves-fda-510k.jpg K220118 - Nitrile Powder Free Examination Gloves, Chemotherapy Nitrile Powder Free Examination Gloves K220118 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Kl-Kepong Rubber Products Sdn. Bhd.. Cleared May 2022. https://www.510kdatabase.net/k220397/ 2022-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k220397-ansistim-pp-fda-510k.jpg K220397 - ANSiStim-PP K220397 is a FDA 510(k) cleared neurology medical device. Manufacturer: Dyansys, Inc.. Cleared May 2022. https://www.510kdatabase.net/k220430/ 2022-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k220430-capsulo-fda-510k.jpg K220430 - Capsulo K220430 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Quantel Medical. Cleared May 2022. https://www.510kdatabase.net/k220442/ 2022-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k220442-synguard-nitrile-exam-glove-fda-510k.jpg K220442 - Synguard Nitrile Exam Glove K220442 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Tianjin Aoshang Outdoor Equipment Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k220723/ 2022-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k220723-hand-trauma-screw-system-fda-510k.jpg K220723 - Hand Trauma Screw System K220723 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Skeletal Dynamics, Inc.. Cleared May 2022. https://www.510kdatabase.net/k220738/ 2022-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k220738-motive-knee-wrap-fda-510k.jpg K220738 - Motive Knee Wrap K220738 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Cymedica Orthopedics, Inc.. Cleared May 2022. https://www.510kdatabase.net/k220740/ 2022-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k220740-power-wheelchair-w5907-q50-r-carbon-fda-510k.jpg K220740 - Power Wheelchair, W5907 (Q50 R Carbon) K220740 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zhejiang Innuovo Rehabilitation Devices Co.,Ltd. Cleared May 2022. https://www.510kdatabase.net/k220747/ 2022-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k220747-power-wheelchair-n5515b-fda-510k.jpg K220747 - Power Wheelchair (N5515B) K220747 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zhejiang Innuovo Rehabilitation Devices Co.,Ltd. Cleared May 2022. https://www.510kdatabase.net/k221001/ 2022-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k221001-ipl-home-use-hair-removal-device-fda-510k.jpg K221001 - IPL Home Use Hair Removal Device K221001 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k211152/ 2022-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k211152-durex-condom-with-benzocaine-fda-510k.jpg K211152 - Durex Condom with Benzocaine K211152 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Rb Health (Us), LLC. Cleared May 2022. https://www.510kdatabase.net/k212909/ 2022-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k212909-vacuumcushions-feetsupports-leps-lower-fda-510k.jpg K212909 - VacuumCushions, FeetSupports, LEPS (Lower Extermities Positioning System), CouchStrips K212909 is a FDA 510(k) cleared radiology medical device. Manufacturer: Macromedics BV. Cleared May 2022. https://www.510kdatabase.net/k213001/ 2022-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k213001-procedure-mask-surgical-mask-fda-510k.jpg K213001 - Procedure Mask, Surgical Mask K213001 is a FDA 510(k) cleared general hospital medical device. Manufacturer: A Plus International, Inc.. Cleared May 2022. https://www.510kdatabase.net/k213177/ 2022-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k213177-plus-medical-cover-gown-fda-510k.jpg K213177 - Plus Medical Cover Gown K213177 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Foshan Nanhai Plus Medical Co, Ltd.. Cleared May 2022. https://www.510kdatabase.net/k213299/ 2022-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k213299-wireless-eeg-system-fda-510k.jpg K213299 - Wireless EEG System K213299 is a FDA 510(k) cleared neurology medical device. Manufacturer: Pascall Systems, Inc.. Cleared May 2022. https://www.510kdatabase.net/k220250/ 2022-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k220250-sterile-powder-free-nitrile-fda-510k.jpg K220250 - Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs K220250 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Grand Work Plastic Products Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k220446/ 2022-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k220446-versana-balance-fda-510k.jpg K220446 - Versana Balance K220446 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared May 2022. https://www.510kdatabase.net/k220587/ 2022-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k220587-evis-exera-iii-duodenovideoscope-fda-510k.jpg K220587 - Evis Exera III Duodenovideoscope Olympus TJF-Q190V K220587 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared May 2022. https://www.510kdatabase.net/k220662/ 2022-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k220662-disposable-barrier-sleeves-fda-510k.jpg K220662 - Disposable Barrier Sleeves K220662 is a FDA 510(k) cleared dental medical device. Manufacturer: Premium Plus (Dongguan) Limited. Cleared May 2022. https://www.510kdatabase.net/k210585/ 2022-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k210585-bd-ctgctv2-fda-510k.jpg K210585 - BD CTGCTV2 K210585 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson and Company. Cleared May 2022. https://www.510kdatabase.net/k212519/ 2022-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k212519-overjet-caries-assist-fda-510k.jpg K212519 - Overjet Caries Assist K212519 is a FDA 510(k) cleared radiology medical device. Manufacturer: Overjet, Inc.. Cleared May 2022. https://www.510kdatabase.net/k213004/ 2022-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k213004-needle-free-connector-fda-510k.jpg K213004 - Needle Free Connector K213004 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medcaptain Life Science Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k214008/ 2022-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k214008-dental-diode-laser-fda-510k.jpg K214008 - Dental diode laser K214008 is a FDA 510(k) cleared dental medical device. Manufacturer: Shenzhen Soga Technology Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k220427/ 2022-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k220427-white-nitrile-powder-free-patient-fda-510k.jpg K220427 - White Nitrile Powder-Free Patient Examination Glove, Non Sterile K220427 is a FDA 510(k) cleared general hospital medical device. Manufacturer: One Glove Industrial Sdn Bhd. Cleared May 2022. https://www.510kdatabase.net/k220428/ 2022-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k220428-black-nitrile-powder-free-patient-fda-510k.jpg K220428 - Black Nitrile Powder-Free Patient Examination Glove, Non-Sterile K220428 is a FDA 510(k) cleared general hospital medical device. Manufacturer: One Glove Industrial Sdn Bhd. Cleared May 2022. https://www.510kdatabase.net/k220711/ 2022-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k220711-seaspine-meridian-system-seaspine-fda-510k.jpg K220711 - SeaSpine Meridian System, SeaSpine Meridian Anterior Plate System K220711 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared May 2022. https://www.510kdatabase.net/k220727/ 2022-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k220727-inheart-models-fda-510k.jpg K220727 - inHEART MODELS K220727 is a FDA 510(k) cleared radiology medical device. Manufacturer: Inheart, Sas. Cleared May 2022. https://www.510kdatabase.net/k221059/ 2022-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k221059-identity-imprint-knee-replacement-fda-510k.jpg K221059 - Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) K221059 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Conformis, Inc.. Cleared May 2022. https://www.510kdatabase.net/k221136/ 2022-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k221136-radiforce-mx243w-fda-510k.jpg K221136 - RadiForce MX243W K221136 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eizo Corporation. Cleared May 2022. https://www.510kdatabase.net/k203429/ 2022-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k203429-xpert-gbs-lb-xc-genexpert-dx-system-fda-510k.jpg K203429 - Xpert GBS LB XC, GeneXpert Dx System, GeneXpert Infinity System K203429 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Cepheid. Cleared May 2022. https://www.510kdatabase.net/k203527/ 2022-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k203527-immunalysis-tapentadol-urine-heia-fda-510k.jpg K203527 - Immunalysis Tapentadol Urine HEIA K203527 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Lmmunalysis Corporation. Cleared May 2022. https://www.510kdatabase.net/k211840/ 2022-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k211840-sight-olo-fda-510k.jpg K211840 - Sight OLO K211840 is a FDA 510(k) cleared hematology medical device. Manufacturer: S.D. Sight Diagnostics , Ltd.. Cleared May 2022. https://www.510kdatabase.net/k213022/ 2022-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k213022-cefla-dental-micromotors-i-mmr-i-mmr-l-fda-510k.jpg K213022 - CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED K213022 is a FDA 510(k) cleared dental medical device. Manufacturer: Cefla S.C.. Cleared May 2022. https://www.510kdatabase.net/k213946/ 2022-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k213946-compass-bds-biliary-stent-fda-510k.jpg K213946 - Compass BDS Biliary Stent K213946 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Ireland, Ltd.. Cleared May 2022. https://www.510kdatabase.net/k220414/ 2022-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k220414-versacross-connect-transseptal-dilator-fda-510k.jpg K220414 - VersaCross Connect Transseptal Dilator K220414 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baylis Medical Company, Inc.. Cleared May 2022. https://www.510kdatabase.net/k203711/ 2022-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k203711-iwl2020-blood-glucose-monitoring-system-fda-510k.jpg K203711 - IWL2020 Blood Glucose Monitoring System K203711 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diabetes Care, Inc.. Cleared May 2022. https://www.510kdatabase.net/k211021/ 2022-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k211021-sterile-biliary-stone-retrieval-fda-510k.jpg K211021 - Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible K211021 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Micro-Tech (Nanjing) Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k211685/ 2022-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k211685-elecsys-testosterone-ii-fda-510k.jpg K211685 - Elecsys Testosterone II K211685 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared May 2022. https://www.510kdatabase.net/k211966/ 2022-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k211966-segment-3dprint-fda-510k.jpg K211966 - Segment 3DPrint K211966 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medviso AB. Cleared May 2022. https://www.510kdatabase.net/k212092/ 2022-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k212092-portable-folding-electric-wheelchair-fda-510k.jpg K212092 - Portable Folding Electric Wheelchair (Model: DC01) K212092 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Anhui Jbh Medical Apparatus Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k212289/ 2022-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k212289-neurostar-advanced-therapy-for-fda-510k.jpg K212289 - NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar K212289 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neuronetics, Inc.. Cleared May 2022. https://www.510kdatabase.net/k212555/ 2022-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k212555-nellcor-oxysoft-neonatal-adult-spo2-fda-510k.jpg K212555 - Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftN, Nellcor OxySoft Neonatal-Adult SpO2 Sensor, OxySoftNHC K212555 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Covidien, LLC. Cleared May 2022. https://www.510kdatabase.net/k212564/ 2022-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k212564-electric-breast-pump-fda-510k.jpg K212564 - Electric Breast Pump K212564 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Guangdong Horigen Mother & Baby Products Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k212582/ 2022-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k212582-spyglass-discover-balloon-dilation-fda-510k.jpg K212582 - SpyGlass Discover Balloon Dilation Catheter K212582 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared May 2022. https://www.510kdatabase.net/k212657/ 2022-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k212657-quantum-heater-cooler-fda-510k.jpg K212657 - Quantum Heater-Cooler K212657 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Spectrum Medical , Ltd.. Cleared May 2022. https://www.510kdatabase.net/k213788/ 2022-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k213788-tensems-stimulator-model-kres100d-fda-510k.jpg K213788 - TENS&EMS STIMULATOR (Model: KRES100D, KRES1010, KRES1020, KRES1080) K213788 is a FDA 510(k) cleared neurology medical device. Manufacturer: Dongguan Bohuikang Technology Co.,Ltd. Cleared May 2022. https://www.510kdatabase.net/k213884/ 2022-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k213884-disposable-eeg-cable-fda-510k.jpg K213884 - Disposable EEG cable K213884 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Changke Connect Electronics Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k213900/ 2022-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k213900-wavi-scan-eeg-system-and-accessories-fda-510k.jpg K213900 - WAVi SCAN EEG System and Accessories K213900 is a FDA 510(k) cleared neurology medical device. Manufacturer: Wavi Co.. Cleared May 2022. https://www.510kdatabase.net/k213935/ 2022-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k213935-pisces-sa-standalone-alif-interbody-fda-510k.jpg K213935 - PISCES-SA Standalone ALIF Interbody System K213935 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osseus Fusion Systems. Cleared May 2022. https://www.510kdatabase.net/k213975/ 2022-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k213975-keops-balance-analyzer-3d-fda-510k.jpg K213975 - KEOPS Balance Analyzer 3D K213975 is a FDA 510(k) cleared radiology medical device. Manufacturer: S.M.A.I.O. Cleared May 2022. https://www.510kdatabase.net/k214072/ 2022-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k214072-masimo-o3-regional-oximeter-system-fda-510k.jpg K214072 - Masimo O3 Regional Oximeter System K214072 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Masimo Corporation. Cleared May 2022. https://www.510kdatabase.net/k214108/ 2022-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k214108-medline-orbis-chemo-surgical-gown-fda-510k.jpg K214108 - Medline Orbis Chemo Surgical Gown K214108 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, LP. Cleared May 2022. https://www.510kdatabase.net/k220110/ 2022-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k220110-quantum-pureflow-standard-heat-fda-510k.jpg K220110 - Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger K220110 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Qura S.R.L. Cleared May 2022. https://www.510kdatabase.net/k220269/ 2022-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k220269-hm70-evo-diagnostic-ultrasound-system-fda-510k.jpg K220269 - HM70 EVO Diagnostic Ultrasound System K220269 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Medison Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k220653/ 2022-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k220653-astroglide-glycerin-paraben-free-fda-510k.jpg K220653 - Astroglide Glycerin & Paraben Free K220653 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Biofilm, Inc.. Cleared May 2022. https://www.510kdatabase.net/k220664/ 2022-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k220664-newtom-7g-fda-510k.jpg K220664 - NewTom 7G K220664 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cefla S.C.. Cleared May 2022. https://www.510kdatabase.net/k220689/ 2022-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k220689-vatech-clismile-fda-510k.jpg K220689 - Vatech Clismile K220689 is a FDA 510(k) cleared dental medical device. Manufacturer: Rayence Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k221046/ 2022-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k221046-invu-by-nuvo-fda-510k.jpg K221046 - Invu by Nuvo K221046 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Nuvo- Group , Ltd.. Cleared May 2022. https://www.510kdatabase.net/k210411/ 2022-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k210411-posisep-ear-fragmentable-ear-dressing-fda-510k.jpg K210411 - PosiSep EAR Fragmentable Ear Dressing K210411 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Hemostasis, LLC. Cleared May 2022. https://www.510kdatabase.net/k210565/ 2022-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k210565-infrared-thermometer-model-aet-r1b1-fda-510k.jpg K210565 - Infrared Thermometer, Model: AET-R1B1, AET-R161, AET-R171, AET-R1D1, AET-R1D2, AET-R1F1, AET-R701, AET-R711 K210565 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Alicn Medical (Shenzhen), Inc.. Cleared May 2022. https://www.510kdatabase.net/k211529/ 2022-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k211529-navirfa-scope-fda-510k.jpg K211529 - NAVIRFA Scope K211529 is a FDA 510(k) cleared radiology medical device. Manufacturer: Navifus Corporation. Cleared May 2022. https://www.510kdatabase.net/k212346/ 2022-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k212346-infrared-thermometer-model-pg-irt1612-fda-510k.jpg K212346 - Infrared Thermometer, Model: PG-IRT1612, PG-IRT1613, PG-IRT1615, PG-IRT1618 K212346 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen Pango Medical Electronics Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k212434/ 2022-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k212434-neuromuscular-transmission-monitor-tof3d-fda-510k.jpg K212434 - Neuromuscular Transmission Monitor TOF3D K212434 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: MIPM Mammendorfer Institut f?r Physik und Medizin GmbH. Cleared May 2022. https://www.510kdatabase.net/k212756/ 2022-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k212756-discectomy-navigation-ready-fda-510k.jpg K212756 - Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set K212756 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International SARL. Cleared May 2022. https://www.510kdatabase.net/k220041/ 2022-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k220041-handpico-fda-510k.jpg K220041 - HandPICO K220041 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Vydence Medical Industria E Comercio Ltda. Cleared May 2022. https://www.510kdatabase.net/k220559/ 2022-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k220559-17hq901g-b-fda-510k.jpg K220559 - 17HQ901G-B K220559 is a FDA 510(k) cleared radiology medical device. Manufacturer: Lg Electronics.Inc. Cleared May 2022. https://www.510kdatabase.net/k220685/ 2022-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k220685-hightop-multi-drug-urine-test-cup-fda-510k.jpg K220685 - HIGHTOP Multi-Drug Urine Test Cup, HIGHTOP Multi-Drug Urine Test Cup Rx K220685 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Qingdao Hightop Biotech Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k220691/ 2022-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k220691-liquid-061-guide-catheter-extension-fda-510k.jpg K220691 - LiquID 061 Guide Catheter Extension, LiquID 071 Guide Catheter Extension K220691 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Seigla Medical, Inc.. Cleared May 2022. https://www.510kdatabase.net/k220716/ 2022-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k220716-spartan-sc-069-fda-510k.jpg K220716 - Spartan SC 069 K220716 is a FDA 510(k) cleared neurology medical device. Manufacturer: Spartan Micro, Inc.. Cleared May 2022. https://www.510kdatabase.net/k221013/ 2022-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k221013-gia-auto-suture-stapler-with-dst-fda-510k.jpg K221013 - GIA Auto Suture Stapler with DST Series Technology K221013 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien. Cleared May 2022. https://www.510kdatabase.net/k221016/ 2022-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k221016-steriking-packaging-for-medical-devices-fda-510k.jpg K221016 - Steriking Packaging for Medical Devices K221016 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wipak OY. Cleared May 2022. https://www.510kdatabase.net/k221044/ 2022-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k221044-acqguide-vue-steerable-sheath-fda-510k.jpg K221044 - AcQGuide® VUE Steerable Sheath K221044 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Acutus Medical, Inc.. Cleared May 2022. https://www.510kdatabase.net/k221057/ 2022-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k221057-viatrac-14-plus-peripheral-dilatation-fda-510k.jpg K221057 - Viatrac 14 Plus Peripheral Dilatation Catheter K221057 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Vascular. Cleared May 2022. https://www.510kdatabase.net/k201302/ 2022-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k201302-liveone-fda-510k.jpg K201302 - LiveOne K201302 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Livemetric (Medical) S.A.. Cleared May 2022. https://www.510kdatabase.net/k211036/ 2022-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k211036-plus-medical-chemotherapy-gown-fda-510k.jpg K211036 - Plus Medical Chemotherapy Gown K211036 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Foshan Nanhai Plus Medical Co, Ltd.. Cleared May 2022. https://www.510kdatabase.net/k211707/ 2022-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k211707-bioteke-sterile-disposable-virus-fda-510k.jpg K211707 - BioTeke Sterile Disposable Virus Sampling Kit K211707 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bioteke Corporation (Wuxi) Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k212257/ 2022-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k212257-electronic-thermometer-model-aet-e201-fda-510k.jpg K212257 - Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231, AET-E241, AET-E251, AET-E301, AET-E311 K212257 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Alicn Medical (Shenzhen), Inc.. Cleared May 2022. https://www.510kdatabase.net/k212588/ 2022-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k212588-conquest-40-pta-dilatation-catheter-fda-510k.jpg K212588 - Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation Catheter, Vida BAV Balloon Valvuloplasty Catheter K212588 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 2022. https://www.510kdatabase.net/k213420/ 2022-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k213420-waveform-l-system-waveform-to-system-fda-510k.jpg K213420 - WaveForm L System, WaveForm TO System, WaveForm TA System K213420 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared May 2022. https://www.510kdatabase.net/k213526/ 2022-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k213526-aurora-rt-fda-510k.jpg K213526 - Aurora-RT K213526 is a FDA 510(k) cleared radiology medical device. Manufacturer: Magnettx Oncology Solutions , Ltd.. Cleared May 2022. https://www.510kdatabase.net/k213550/ 2022-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k213550-hydropicc-5f-dual-lumen-catheter-fda-510k.jpg K213550 - HydroPICC 5F Dual Lumen Catheter K213550 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Access Vascular, Inc.. Cleared May 2022. https://www.510kdatabase.net/k214065/ 2022-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k214065-rosa-one-brain-application-fda-510k.jpg K214065 - ROSA ONE Brain application K214065 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtech S.A.S. Cleared May 2022. https://www.510kdatabase.net/k220030/ 2022-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k220030-vista-ophthalmics-vitrectomy-probe-fda-510k.jpg K220030 - Vista Ophthalmics Vitrectomy Probe K220030 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Vista Ophthalmics, LLC. Cleared May 2022. https://www.510kdatabase.net/k220700/ 2022-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k220700-heart5r-110-portable-x-ray-machine-fda-510k.jpg K220700 - Heart5R-110 Portable X-Ray Machine, Heart3R-110 Portable X-ray Machine K220700 is a FDA 510(k) cleared radiology medical device. Manufacturer: Yian Medical Technology (Haining) Co., Ltd.. Cleared May 2022. https://www.510kdatabase.net/k220704/ 2022-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k220704-serranator-pta-serration-balloon-fda-510k.jpg K220704 - Serranator PTA Serration Balloon Catheter K220704 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cagent Vascular, LLC. Cleared May 2022. https://www.510kdatabase.net/k220705/ 2022-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k220705-myknee-r-pin-positioners-fda-510k.jpg K220705 - MyKnee R Pin Positioners K220705 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared May 2022. https://www.510kdatabase.net/den200072/ 2022-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/den200072-lumipulse-g-amyloid-ratio-1-421-40-fda-510k.jpg DEN200072 - Lumipulse G ß-Amyloid Ratio (1-42/1-40) DEN200072 is a FDA 510(k) cleared immunology medical device. Manufacturer: Fujirebio Diagnostics,Inc.. Cleared May 2022. https://www.510kdatabase.net/k212064/ 2022-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k212064-orchid-safety-release-valvetm-fda-510k.jpg K212064 - Orchid Safety Release Valve(TM) K212064 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Linear Health Sciences, LLC. Cleared May 2022. https://www.510kdatabase.net/k212915/ 2022-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k212915-mvision-ai-segmentation-fda-510k.jpg K212915 - MVision AI Segmentation K212915 is a FDA 510(k) cleared radiology medical device. Manufacturer: MVision AI. Cleared May 2022. https://www.510kdatabase.net/k213302/ 2022-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k213302-exoplan-fda-510k.jpg K213302 - exoplan K213302 is a FDA 510(k) cleared radiology medical device. Manufacturer: Exocad GmbH. Cleared May 2022. https://www.510kdatabase.net/k213594/ 2022-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k213594-echolaser-x4-fda-510k.jpg K213594 - ECHOLASER X4 K213594 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Elesta S.P.A. Cleared May 2022. https://www.510kdatabase.net/k220013/ 2022-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k220013-x100ht-with-slide-loader-with-full-fda-510k.jpg K220013 - X100HT with Slide Loader with Full Field Peripheral Blood Smear (PBS) Application K220013 is a FDA 510(k) cleared hematology medical device. Manufacturer: Scopio Labs , Ltd.. Cleared May 2022. https://www.510kdatabase.net/k220306/ 2022-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k220306-ecgenius-system-fda-510k.jpg K220306 - ECGenius System K220306 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cath Vision Aps. Cleared May 2022. https://www.510kdatabase.net/k220311/ 2022-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k220311-cardiovascular-angiography-system-fda-510k.jpg K220311 - Cardiovascular Angiography System K220311 is a FDA 510(k) cleared radiology medical device. Manufacturer: Allengers Medical Systems Limited. Cleared May 2022. https://www.510kdatabase.net/k220628/ 2022-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k220628-link-endo-model-evo-knee-system-fda-510k.jpg K220628 - LINK Endo-Model EVO Knee System K220628 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Waldemar Link GmbH & Co. KG. Cleared May 2022. https://www.510kdatabase.net/k220791/ 2022-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k220791-surgical-and-prosthetic-trays-fda-510k.jpg K220791 - Surgical and Prosthetic Trays K220791 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Dentsply Sirona. Cleared May 2022. https://www.510kdatabase.net/k221010/ 2022-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k221010-intraox-20-handheld-tissue-oximeter-fda-510k.jpg K221010 - Intra.Ox 2.0 Handheld Tissue Oximeter K221010 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Vioptix, Inc.. Cleared May 2022. https://www.510kdatabase.net/k211180/ 2022-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k211180-liver-suite-fda-510k.jpg K211180 - Liver Suite K211180 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems SCS. Cleared May 2022. https://www.510kdatabase.net/k212348/ 2022-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k212348-alphalok-plating-system-fda-510k.jpg K212348 - ALPHALOK™ Plating System K212348 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Vilex, LLC. Cleared May 2022. https://www.510kdatabase.net/k213837/ 2022-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k213837-arthrx-fracture-plates-fda-510k.jpg K213837 - Arthrx Fracture Plates K213837 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared May 2022. https://www.510kdatabase.net/k213877/ 2022-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k213877-exactechgps-system-fda-510k.jpg K213877 - ExactechGPS® System K213877 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Blue Ortho. Cleared May 2022. https://www.510kdatabase.net/k220283/ 2022-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k220283-tens-pms-modelsm9009-sm9021-sm9128h-fda-510k.jpg K220283 - TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033) K220283 is a FDA 510(k) cleared neurology medical device. Manufacturer: Hong Qiangxing (Shenzhen) Electronics Limited. Cleared May 2022. https://www.510kdatabase.net/k220341/ 2022-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k220341-arx-modular-spinal-system-fda-510k.jpg K220341 - ARx Modular Spinal System K220341 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared May 2022. https://www.510kdatabase.net/den200063/ 2022-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/den200063-kerasave-fda-510k.jpg DEN200063 - Kerasave DEN200063 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Al.Chi.Mi.A. S.R.L. Cleared May 2022. https://www.510kdatabase.net/k220243/ 2022-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k220243-ultiri-measurement-system-fda-510k.jpg K220243 - Ultiri Measurement System K220243 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared Apr 2022. https://www.510kdatabase.net/k201956/ 2022-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k201956-zeus-ifa-ana-hep-2-test-system-zeus-fda-510k.jpg K201956 - Zeus IFA ANA HEp-2 Test System, Zeus dIFine K201956 is a FDA 510(k) cleared immunology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k202977/ 2022-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k202977-alinity-m-sti-assay-fda-510k.jpg K202977 - Alinity m STI Assay K202977 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Molecular, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k211350/ 2022-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k211350-bindex-bi-2-fda-510k.jpg K211350 - Bindex BI-2 K211350 is a FDA 510(k) cleared radiology medical device. Manufacturer: Bone Index Finland , Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k212422/ 2022-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k212422-disposable-surgical-isolation-gown-fda-510k.jpg K212422 - Disposable Surgical Isolation Gown K212422 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Crown Name Disposable Hygiene Products Fty., Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k212430/ 2022-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k212430-bonree-nelaton-catheter-fda-510k.jpg K212430 - BONREE Nelaton Catheter K212430 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Bonree Medical Co., Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k212514/ 2022-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k212514-safety-pen-needle-for-single-use-fda-510k.jpg K212514 - Safety Pen Needle for Single Use, Insulin Pen Needles K212514 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Berpu Medical Technology Co., Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k212711/ 2022-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k212711-steritite-container-system-with-fda-510k.jpg K212711 - SteriTite Container System with MediTray Products K212711 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Case Medical, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k213334/ 2022-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k213334-monarch-platform-urology-fda-510k.jpg K213334 - Monarch Platform, Urology K213334 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Auris Health, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k213482/ 2022-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k213482-tia-tip-cariosity-transillumination-fda-510k.jpg K213482 - TIA Tip, Cariosity, Transillumination Accessory Tip K213482 is a FDA 510(k) cleared dental medical device. Manufacturer: D4D Technologies, LLC. Cleared Apr 2022. https://www.510kdatabase.net/k213649/ 2022-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k213649-bodytom-64-fda-510k.jpg K213649 - BodyTom 64 K213649 is a FDA 510(k) cleared radiology medical device. Manufacturer: Neurologica Corporation. Cleared Apr 2022. https://www.510kdatabase.net/k214045/ 2022-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k214045-freedomedge-syringe-infusion-system-fda-510k.jpg K214045 - FreedomEdge Syringe Infusion System K214045 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Repro-Medical System, Inc., Dba Koru Medical Systems. Cleared Apr 2022. https://www.510kdatabase.net/k220038/ 2022-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k220038-camber-spine-navigation-system-fda-510k.jpg K220038 - Camber Spine Navigation System K220038 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Camber Spine Technologies. Cleared Apr 2022. https://www.510kdatabase.net/k220189/ 2022-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k220189-lisa-laser-surgical-fibers-fda-510k.jpg K220189 - LISA Laser Surgical Fibers K220189 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Omni-Guide Holdings, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k220271/ 2022-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k220271-hand-diagnostic-radiography-imaging-fda-510k.jpg K220271 - Hand Diagnostic Radiography Imaging System K220271 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nanoray Biotech Co., Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k220295/ 2022-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k220295-arietta-50-fda-510k.jpg K220295 - ARIETTA 50 K220295 is a FDA 510(k) cleared radiology medical device. Manufacturer: Fujifilm Healthcare Corporation. Cleared Apr 2022. https://www.510kdatabase.net/k220338/ 2022-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k220338-exactrac-dynamic-fda-510k.jpg K220338 - ExacTrac Dynamic K220338 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab AG. Cleared Apr 2022. https://www.510kdatabase.net/k220383/ 2022-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k220383-lobo-vascular-occlusion-system-models-fda-510k.jpg K220383 - LOBO Vascular Occlusion System (models LOBO-7 and LOBO-9) K220383 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Okami Medical. Cleared Apr 2022. https://www.510kdatabase.net/k220417/ 2022-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k220417-spectrum-iq-infusion-system-with-dose-fda-510k.jpg K220417 - Spectrum IQ Infusion System with Dose IQ Safety Software K220417 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corporation. Cleared Apr 2022. https://www.510kdatabase.net/k220590/ 2022-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k220590-apromise-x-fda-510k.jpg K220590 - aPROMISE X K220590 is a FDA 510(k) cleared radiology medical device. Manufacturer: Exini Diagnostics AB. Cleared Apr 2022. https://www.510kdatabase.net/k220608/ 2022-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k220608-accu-chek-fastclix-blood-lancing-system-fda-510k.jpg K220608 - Accu-Chek FastClix Blood Lancing System K220608 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Roche Diabetes Care, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k220684/ 2022-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k220684-oryx-cloud-imaging-fda-510k.jpg K220684 - Oryx Cloud Imaging K220684 is a FDA 510(k) cleared radiology medical device. Manufacturer: Oryx Dental Software, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k220695/ 2022-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k220695-elite-biomedical-solutions-dose-fda-510k.jpg K220695 - Elite Biomedical Solutions Dose Request Cord K220695 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Elite Biomedical Solutions. Cleared Apr 2022. https://www.510kdatabase.net/k220899/ 2022-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k220899-oxehealth-vital-signs-fda-510k.jpg K220899 - Oxehealth Vital Signs K220899 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Oxehealth Limited. Cleared Apr 2022. https://www.510kdatabase.net/k220939/ 2022-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k220939-magnetom-lumina-and-magnetom-vida-fit-fda-510k.jpg K220939 - MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A K220939 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k221005/ 2022-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k221005-eea-circular-stapler-with-tri-staple-fda-510k.jpg K221005 - EEA Circular Stapler with Tri-Staple Technology K221005 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien. Cleared Apr 2022. https://www.510kdatabase.net/k221006/ 2022-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k221006-gia-stapler-with-tri-staple-technology-fda-510k.jpg K221006 - GIA Stapler with Tri-Staple Technology K221006 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien. Cleared Apr 2022. https://www.510kdatabase.net/den200066/ 2022-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/den200066-biofire-joint-infection-ji-panel-fda-510k.jpg DEN200066 - BioFire Joint Infection (JI) Panel DEN200066 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Biofire Diagnostics, LLC. Cleared Apr 2022. https://www.510kdatabase.net/k202691/ 2022-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k202691-ortholock-anchorage-devices-fda-510k.jpg K202691 - Ortholock Anchorage Devices K202691 is a FDA 510(k) cleared dental medical device. Manufacturer: Craniofacial Technologies, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k211713/ 2022-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k211713-angiocloud-service-fda-510k.jpg K211713 - AngioCloud Service K211713 is a FDA 510(k) cleared radiology medical device. Manufacturer: Angiocloud, LLC. Cleared Apr 2022. https://www.510kdatabase.net/k211715/ 2022-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k211715-retinai-discovery-fda-510k.jpg K211715 - RetinAI Discovery K211715 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Retinai Medical AG. Cleared Apr 2022. https://www.510kdatabase.net/k212477/ 2022-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k212477-earp-interbody-system-fda-510k.jpg K212477 - EARP Interbody System K212477 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nvision Biomedical Technologies, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k212512/ 2022-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k212512-g7-vivacit-e-freedom-constrained-liner-fda-510k.jpg K212512 - G7® Vivacit-E® Freedom® Constrained Liner K212512 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k213278/ 2022-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k213278-planmed-verity-fda-510k.jpg K213278 - Planmed Verity K213278 is a FDA 510(k) cleared radiology medical device. Manufacturer: Planmed OY. Cleared Apr 2022. https://www.510kdatabase.net/k213607/ 2022-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k213607-geistlich-wound-matrix-plus-fda-510k.jpg K213607 - Geistlich Wound Matrix PLUS K213607 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Geistlich Pharma AG. Cleared Apr 2022. https://www.510kdatabase.net/k213921/ 2022-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k213921-microthin-natural-rubber-latex-condom-fda-510k.jpg K213921 - Microthin Natural Rubber Latex Condom K213921 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Suretex Limited. Cleared Apr 2022. https://www.510kdatabase.net/k220244/ 2022-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k220244-dvr-crosslock-wrist-spanning-plate-fda-510k.jpg K220244 - DVR® Crosslock Wrist Spanning Plate (131849181) K220244 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Pioneer Surgical Technology, Inc D.B.A Resolve Surgical Tech. Cleared Apr 2022. https://www.510kdatabase.net/k220264/ 2022-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k220264-efai-rtsuite-ct-hn-segmentation-system-fda-510k.jpg K220264 - EFAI RTSuite CT HN-Segmentation System K220264 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ever Fortune.Ai, Co., Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k220536/ 2022-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k220536-digital-flat-panel-detector-fda-510k.jpg K220536 - Digital flat panel detector K220536 is a FDA 510(k) cleared radiology medical device. Manufacturer: Iray Technology Taicang , Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k212441/ 2022-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k212441-philips-incisive-ct-fda-510k.jpg K212441 - Philips Incisive CT K212441 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Healthcare (Suzhou) Co., Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k213040/ 2022-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k213040-nitrile-patient-examination-gloves-fda-510k.jpg K213040 - Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs,Nitrile Patient Examination Gloves Black Tested For Use With Chemotherapy Drugs K213040 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guangdong Kingfa Sci. & Tech.Co., Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k213077/ 2022-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k213077-automatically-retractable-safety-syringe-fda-510k.jpg K213077 - Automatically Retractable Safety Syringe K213077 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zhejiang Lingyang Medical Apparatus Co., Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k213236/ 2022-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k213236-eplex-blood-culture-identification-fda-510k.jpg K213236 - ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel K213236 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Genmark Diagnostics, Incorporated. Cleared Apr 2022. https://www.510kdatabase.net/k213265/ 2022-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k213265-tomey-corneaanterior-segment-oct-casia2-fda-510k.jpg K213265 - Tomey Cornea/Anterior Segment OCT CASIA2 K213265 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Tomey Corporation. Cleared Apr 2022. https://www.510kdatabase.net/k220231/ 2022-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k220231-gyrostim-fda-510k.jpg K220231 - GyroStim K220231 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Ultrathera Technologies, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k220568/ 2022-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k220568-diamondback-360-peripheral-orbital-fda-510k.jpg K220568 - Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series K220568 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cardiovascualr Systems, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k220592/ 2022-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k220592-venus-blissmax-fda-510k.jpg K220592 - Venus BlissMAX K220592 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Venus Concept USA, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k220604/ 2022-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k220604-extesia-introducer-sheath-set-fda-510k.jpg K220604 - EXTesia Introducer Sheath Set K220604 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Curatia Medical Co.. Cleared Apr 2022. https://www.510kdatabase.net/k220645/ 2022-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k220645-hand-held-ipl-device-jovs-hair-removal-fda-510k.jpg K220645 - Hand-held IPL device (JOVS Hair Removal Device) K220645 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Qianyu Technology Co., Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k220892/ 2022-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k220892-exsomed-innate-nanotm-lag-screw-system-fda-510k.jpg K220892 - ExsoMed INnate NanoTM Lag Screw System K220892 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exsomed Corp.. Cleared Apr 2022. https://www.510kdatabase.net/k220893/ 2022-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k220893-strados-remote-electronic-stethoscope-fda-510k.jpg K220893 - Strados Remote Electronic Stethoscope Platform (RESP) K220893 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Strados Labs, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k220898/ 2022-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k220898-noxboxi-nitric-oxide-delivery-system-fda-510k.jpg K220898 - NOxBOXi Nitric Oxide Delivery System K220898 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Linde Gas & Equipment, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k210250/ 2022-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k210250-speedcath-compact-male-fda-510k.jpg K210250 - SpeedCath Compact Male K210250 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Coloplast. Cleared Apr 2022. https://www.510kdatabase.net/k210284/ 2022-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k210284-manasport-fda-510k.jpg K210284 - ManaSport K210284 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Manamed, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k212662/ 2022-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k212662-alivecor-qt-service-fda-510k.jpg K212662 - AliveCor QT Service K212662 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: AliveCor, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k213483/ 2022-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k213483-snaploc-wire-lock-fda-510k.jpg K213483 - SnapLoc Wire Lock K213483 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Wilson Cook Medical. Cleared Apr 2022. https://www.510kdatabase.net/k213886/ 2022-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k213886-briefcase-fda-510k.jpg K213886 - BriefCase K213886 is a FDA 510(k) cleared radiology medical device. Manufacturer: Aidoc Medical , Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k220219/ 2022-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k220219-permaloop-suture-permatape-suture-fda-510k.jpg K220219 - PERMALOOP Suture, PERMATAPE Suture K220219 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medos International SARL. Cleared Apr 2022. https://www.510kdatabase.net/k220222/ 2022-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k220222-ipl-hair-removal-device-models-s1-a-s2-fda-510k.jpg K220222 - IPL Hair Removal Device, model(s): S1-A, S2-A, S1, S2, S3, S4 K220222 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Yuwei Electronic Technology Co., Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k220487/ 2022-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k220487-disposable-medical-face-mask-fda-510k.jpg K220487 - Disposable Medical Face Mask K220487 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hubei Mediunion Medical Products Co., Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k220570/ 2022-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k220570-must-mini-posterior-cervical-screws-fda-510k.jpg K220570 - M.U.S.T. MINI Posterior Cervical Screws System Extension K220570 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Apr 2022. https://www.510kdatabase.net/k220896/ 2022-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k220896-legion-inserts-with-jrny-lock-fda-510k.jpg K220896 - Legion Inserts with JRNY Lock K220896 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k213861/ 2022-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k213861-cer-s-fda-510k.jpg K213861 - CER-S K213861 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cardiocalm Srl. Cleared Apr 2022. https://www.510kdatabase.net/k213925/ 2022-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k213925-myocycle-mc-2-home-home-pro-pro-fda-510k.jpg K213925 - MyoCycle MC-2 (Home / Home + / Pro / Pro +) K213925 is a FDA 510(k) cleared neurology medical device. Manufacturer: Myolyn, LLC. Cleared Apr 2022. https://www.510kdatabase.net/k220512/ 2022-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k220512-disposable-surgical-face-mask-m01-m02-fda-510k.jpg K220512 - Disposable Surgical Face Mask (M01, M02) K220512 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Fomed Industries, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k221041/ 2022-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k221041-shockwave-medical-peripheral-fda-510k.jpg K221041 - Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System K221041 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shockwave Medical, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k212530/ 2022-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k212530-ivx-fluid-transfer-set-fda-510k.jpg K212530 - IVX Fluid Transfer Set K212530 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Omnicell, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k213775/ 2022-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k213775-glovatex-white-latex-gloves-glovanil-fda-510k.jpg K213775 - Glovatex™ White Latex Gloves, Glovanil™ Blue Nitrile Gloves K213775 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Avecena Gloves Sdn Bhd. Cleared Apr 2022. https://www.510kdatabase.net/k220503/ 2022-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k220503-tens-device-emeterm-2-model-yf-zty-e2-fda-510k.jpg K220503 - TENS device-EmeTerm 2, Model: YF-ZTY-E2 K220503 is a FDA 510(k) cleared neurology medical device. Manufacturer: Wat Medical Technology, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k203855/ 2022-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k203855-conextions-tr-tendon-repair-system-fda-510k.jpg K203855 - CoNextions TR Tendon Repair System K203855 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Conextions Medical. Cleared Apr 2022. https://www.510kdatabase.net/k211123/ 2022-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k211123-luofucon-silver-wound-gel-luofucon-fda-510k.jpg K211123 - LUOFUCON Silver Wound Gel, LUOFUCON Silver Antimicrobial Wound Gel K211123 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Huizhou Foryou Medical Devices Co., Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k212031/ 2022-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k212031-fp-850-airspiral-adult-niv-and-nhf-fda-510k.jpg K212031 - F&P 850 AirSpiral Adult NIV and NHF Circuit Kit K212031 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Fisher &Paykel Healthcare , Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k212090/ 2022-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k212090-electric-scooter-fda-510k.jpg K212090 - Electric Scooter K212090 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Anhui Jbh Medical Apparatus Co., Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k212400/ 2022-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k212400-sonon-ultrasound-imaging-system-model-fda-510k.jpg K212400 - SONON Ultrasound Imaging System, Model: SONON 500L K212400 is a FDA 510(k) cleared radiology medical device. Manufacturer: Healcerion Co., Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k212608/ 2022-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k212608-ribfix-blu-thoracic-fixation-system-fda-510k.jpg K212608 - RibFix Blu Thoracic Fixation System K212608 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet Microfixation. Cleared Apr 2022. https://www.510kdatabase.net/k212928/ 2022-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k212928-lorals-fda-510k.jpg K212928 - Lorals K212928 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Brazen Goods Inc. Dba Lorals. Cleared Apr 2022. https://www.510kdatabase.net/k212981/ 2022-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k212981-mirrorme3d-modeling-system-fda-510k.jpg K212981 - MirrorMe3D Modeling System K212981 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mirrorme3D, LLC. Cleared Apr 2022. https://www.510kdatabase.net/k213620/ 2022-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k213620-atusa-automated-3d-breast-ultrasound-fda-510k.jpg K213620 - ATUSA™ Automated 3D Breast Ultrasound System K213620 is a FDA 510(k) cleared radiology medical device. Manufacturer: Isono Health, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k213683/ 2022-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k213683-promisemed-fine-biopsy-needle-fda-510k.jpg K213683 - Promisemed Fine Biopsy Needle K213683 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Promisemed Hangzhou Meditech Co., Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k213708/ 2022-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k213708-rosa-knee-system-fda-510k.jpg K213708 - ROSA® Knee System K213708 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthosoft Inc. (d/b/a) Zimmer CAS. Cleared Apr 2022. https://www.510kdatabase.net/k213889/ 2022-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k213889-picostar-fda-510k.jpg K213889 - PicoStar K213889 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Asclepion Laser Technologies GmbH. Cleared Apr 2022. https://www.510kdatabase.net/k213944/ 2022-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k213944-healthost-fda-510k.jpg K213944 - HealthOST K213944 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nanoxai , Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k220574/ 2022-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k220574-hybrid-s70-fda-510k.jpg K220574 - HYBRID S70 K220574 is a FDA 510(k) cleared radiology medical device. Manufacturer: Digimed Co., Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k220588/ 2022-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k220588-avanos-cortrak-2-enteral-access-system-fda-510k.jpg K220588 - Avanos* CORTRAK* 2 Enteral Access System (EAS) K220588 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Avanos Medical, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k220840/ 2022-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k220840-1-series-phototherapy-equipment-fda-510k.jpg K220840 - 1 Series Phototherapy Equipment K220840 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Daavlin Distributing Co.. Cleared Apr 2022. https://www.510kdatabase.net/k220895/ 2022-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k220895-1688-4k-camera-control-unit-with-fda-510k.jpg K220895 - 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K Pendulum Camera Head (1688310130) K220895 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker. Cleared Apr 2022. https://www.510kdatabase.net/k210183/ 2022-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k210183-waterlase-iplus-fda-510k.jpg K210183 - Waterlase iPLus K210183 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Biolase, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k212158/ 2022-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k212158-hydromark-breast-biopsy-site-marker-fda-510k.jpg K212158 - HydroMARK Breast Biopsy Site Marker K212158 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Devicor Medical Products, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k212277/ 2022-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k212277-tempo-tampon-fda-510k.jpg K212277 - Tempo Tampon K212277 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Dong-A Pharmaceutical Co., Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k212737/ 2022-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k212737-inhance-reverse-shoulder-system-fda-510k.jpg K212737 - INHANCE™ Reverse Shoulder System K212737 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Ireland UC. Cleared Apr 2022. https://www.510kdatabase.net/k213452/ 2022-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k213452-gems-h-fda-510k.jpg K213452 - GEMS-H K213452 is a FDA 510(k) cleared neurology medical device. Manufacturer: Samsung Electronics Co., Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k213559/ 2022-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k213559-femto-ldv-z8-femtosecond-surgical-laser-fda-510k.jpg K213559 - FEMTO LDV Z8 Femtosecond Surgical Laser K213559 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Sie Ag,Surgical Instrument Engineering. Cleared Apr 2022. https://www.510kdatabase.net/k213681/ 2022-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k213681-ivory-glove-powder-free-nitrile-fda-510k.jpg K213681 - Ivory Glove Powder-Free Nitrile Examination Gloves K213681 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ivory Gloves Sdn. Bhd.. Cleared Apr 2022. https://www.510kdatabase.net/k213730/ 2022-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k213730-mesi-mtablet-tbi-diagnostic-system-fda-510k.jpg K213730 - MESI mTABLET TBI diagnostic system, MESI mTABLET TBI K213730 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O.. Cleared Apr 2022. https://www.510kdatabase.net/k213795/ 2022-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k213795-videa-caries-assist-fda-510k.jpg K213795 - Videa Caries Assist K213795 is a FDA 510(k) cleared radiology medical device. Manufacturer: Videahealth, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k220175/ 2022-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k220175-gm85-fda-510k.jpg K220175 - GM85 K220175 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Electronics Co., Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k220382/ 2022-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k220382-disposable-nitrile-examination-gloves-fda-510k.jpg K220382 - Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) - Blue/Black/Purple K220382 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Bytech Medical Supplies Co., Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k220605/ 2022-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k220605-venus-bulk-flow-one-fda-510k.jpg K220605 - Venus Bulk Flow ONE K220605 is a FDA 510(k) cleared dental medical device. Manufacturer: Kulzer, LLC. Cleared Apr 2022. https://www.510kdatabase.net/k212022/ 2022-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k212022-3m-attest-vaporized-hydrogen-peroxide-fda-510k.jpg K212022 - 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E K212022 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Apr 2022. https://www.510kdatabase.net/k213484/ 2022-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k213484-smoothcool-hr-system-fda-510k.jpg K213484 - SmoothCool HR System K213484 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Jeisys Medical, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k213974/ 2022-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k213974-gem-flow-coupler-monitor-gem1020m-2-fda-510k.jpg K213974 - GEM FLOW COUPLER Monitor (GEM1020M-2) K213974 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Synovis Micro Companies Alliance, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k220543/ 2022-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k220543-auxo-a300-a150-and-apod-fda-510k.jpg K220543 - Auxo A300, A150 and APod K220543 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Auxo Hair, LLC. Cleared Apr 2022. https://www.510kdatabase.net/k220866/ 2022-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k220866-ekos-endovascular-device-fda-510k.jpg K220866 - EKOS+ Endovascular Device K220866 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific. Cleared Apr 2022. https://www.510kdatabase.net/k220872/ 2022-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k220872-saberscope5-laparoscope-fda-510k.jpg K220872 - Saberscope5 Laparoscope K220872 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Xenocor, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k192931/ 2022-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k192931-v8-nexus-hemoglobin-ultrascreen-v8-fda-510k.jpg K192931 - V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control K192931 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories, Corp.. Cleared Apr 2022. https://www.510kdatabase.net/k211837/ 2022-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k211837-altus-spine-interbody-standalone-fda-510k.jpg K211837 - Altus Spine Interbody Standalone Fusion System K211837 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Altus Partners, LLC. Cleared Apr 2022. https://www.510kdatabase.net/k212241/ 2022-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k212241-quatera-700-fda-510k.jpg K212241 - QUATERA 700 K212241 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Carl Zeiss Meditec, AG. Cleared Apr 2022. https://www.510kdatabase.net/k213930/ 2022-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k213930-brainlab-elements-guide-xt-guide-30-fda-510k.jpg K213930 - Brainlab Elements Guide XT, Guide 3.0 K213930 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Apr 2022. https://www.510kdatabase.net/k220075/ 2022-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k220075-spartan-center-wire-fda-510k.jpg K220075 - Spartan Center Wire K220075 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Spartan Micro, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k220149/ 2022-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k220149-general-radiography-x-ray-system-model-fda-510k.jpg K220149 - General Radiography X-ray System (Model: GR10X 40K), General Radiography X-ray System (Model: GR10X 50K) K220149 is a FDA 510(k) cleared radiology medical device. Manufacturer: Xera Medical Systems & Technology , Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k220152/ 2022-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k220152-tens-pms-modelsm9089-sm9587-sm9592-fda-510k.jpg K220152 - TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555) K220152 is a FDA 510(k) cleared neurology medical device. Manufacturer: Hong Qiangxing (Shenzhen) Electronics Limited. Cleared Apr 2022. https://www.510kdatabase.net/k220810/ 2022-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k220810-infinity-oct-system-and-pass-oct-fda-510k.jpg K220810 - Infinity™ OCT System and PASS OCT Spinal System K220810 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medicrea International. Cleared Apr 2022. https://www.510kdatabase.net/k212952/ 2022-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k212952-psychemedics-homogeneous-enzyme-fda-510k.jpg K212952 - Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Phencyclidine in Hair K212952 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Psychemedics Corporation. Cleared Apr 2022. https://www.510kdatabase.net/k220131/ 2022-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k220131-kyphon-vue-bone-cement-fda-510k.jpg K220131 - KYPHON VuE Bone Cement K220131 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tecres S.P.A.. Cleared Apr 2022. https://www.510kdatabase.net/k220871/ 2022-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k220871-nautilus-fda-510k.jpg K220871 - Nautilus K220871 is a FDA 510(k) cleared radiology medical device. Manufacturer: Dornier Medtech America, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k213408/ 2022-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k213408-bpg-chemoplus-nitrile-patient-fda-510k.jpg K213408 - BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free K213408 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Meditech Gloves Sdn Bhd. Cleared Apr 2022. https://www.510kdatabase.net/k212377/ 2022-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k212377-transcutaneous-electrical-applicator-fda-510k.jpg K212377 - Transcutaneous Electrical Applicator (TEA), Model SNM-FDC01 K212377 is a FDA 510(k) cleared neurology medical device. Manufacturer: Ningbo Medkinetic Medical Device Co., Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k212522/ 2022-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k212522-lilliput-apd-system-fda-510k.jpg K212522 - Lilliput APD System K212522 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC. Cleared Apr 2022. https://www.510kdatabase.net/k212677/ 2022-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k212677-abont-syringe-fda-510k.jpg K212677 - aboNT SYRINGE K212677 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Nipro Medical Corporation. Cleared Apr 2022. https://www.510kdatabase.net/k212773/ 2022-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k212773-ardo-alyssa-fda-510k.jpg K212773 - ARDO Alyssa K212773 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ardo Medical AG. Cleared Apr 2022. https://www.510kdatabase.net/k213350/ 2022-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k213350-mjoule-system-and-accessories-fda-510k.jpg K213350 - mJOULE System and Accessories K213350 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sciton, Inc. Cleared Apr 2022. https://www.510kdatabase.net/k213706/ 2022-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k213706-ai-rad-companion-brain-mr-fda-510k.jpg K213706 - AI-Rad Companion Brain MR K213706 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Healthcare GmbH. Cleared Apr 2022. https://www.510kdatabase.net/k220141/ 2022-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k220141-raystation-11b-fda-510k.jpg K220141 - RayStation 11B K220141 is a FDA 510(k) cleared radiology medical device. Manufacturer: RaySearch Laboratories AB (PUBL). Cleared Apr 2022. https://www.510kdatabase.net/k220459/ 2022-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k220459-mako-total-knee-application-fda-510k.jpg K220459 - Mako Total Knee Application K220459 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Mako Surgical Corp.. Cleared Apr 2022. https://www.510kdatabase.net/k220779/ 2022-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k220779-xd-fda-510k.jpg K220779 - XD K220779 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mirada Medical, Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k220797/ 2022-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k220797-foothold-system-fda-510k.jpg K220797 - FootHold System K220797 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Crossroads Extremity Systems, LLC. Cleared Apr 2022. https://www.510kdatabase.net/k220946/ 2022-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k220946-surgivisio-device-fda-510k.jpg K220946 - SURGIVISIO Device K220946 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ecential Robotics. Cleared Apr 2022. https://www.510kdatabase.net/k212163/ 2022-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k212163-coala-heart-monitor-fda-510k.jpg K212163 - Coala Heart Monitor K212163 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Coala Life AB. Cleared Apr 2022. https://www.510kdatabase.net/k213959/ 2022-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k213959-magnetos-flex-matrix-fda-510k.jpg K213959 - MagnetOs Flex Matrix K213959 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Kuros Biosciences B.V. Cleared Apr 2022. https://www.510kdatabase.net/k214023/ 2022-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k214023-vitek-2-ast-gram-negative-fda-510k.jpg K214023 - VITEK 2 AST-Gram Negative Ciprofloxacin (?0.06 - ?4 µg/mL) K214023 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k214053/ 2022-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k214053-amputee-garment-for-use-with-lympha-fda-510k.jpg K214053 - Amputee Garment for use with Lympha Press Optimal Plus K214053 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Mego Afek AC , Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k220252/ 2022-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k220252-high-retention-attachment-system-fda-510k.jpg K220252 - High Retention Attachment System K220252 is a FDA 510(k) cleared dental medical device. Manufacturer: Zest Anchors, LLC. Cleared Apr 2022. https://www.510kdatabase.net/k220510/ 2022-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k220510-yushan-x-ray-flat-panel-detector-with-fda-510k.jpg K220510 - Yushan X-Ray Flat Panel Detector with DROC K220510 is a FDA 510(k) cleared radiology medical device. Manufacturer: Innocare Optoelectronics Corp.. Cleared Apr 2022. https://www.510kdatabase.net/k220561/ 2022-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k220561-disposable-medical-nitrile-examination-fda-510k.jpg K220561 - Disposable Medical Nitrile Examination Gloves K220561 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Nanjing Universal Medical Equipment Co., Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k220767/ 2022-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k220767-telescan-fda-510k.jpg K220767 - TeleScan K220767 is a FDA 510(k) cleared radiology medical device. Manufacturer: Bb Imaging. Cleared Apr 2022. https://www.510kdatabase.net/k203842/ 2022-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k203842-bendit21-microcatheter-fda-510k.jpg K203842 - Bendit21 Microcatheter K203842 is a FDA 510(k) cleared neurology medical device. Manufacturer: Bend IT Technologies, Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k210146/ 2022-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k210146-cannulated-compression-device-system-fda-510k.jpg K210146 - Cannulated Compression Device System K210146 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthopedic Designs North America, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k210148/ 2022-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k210148-flosteril-poly-reinforced-isolation-fda-510k.jpg K210148 - Flosteril Poly-reinforced Isolation Gowns Model 8120 (Catalogue Number 8120400), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120410), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120430), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120450), Flosteril Poly-reinforced Isolation Gowns Model (Catalogue Number 8120460) K210148 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Flomak Tekstil Makine Muh. Mum. Taah. San. Tic. Ltd. Sti.. Cleared Apr 2022. https://www.510kdatabase.net/k210419/ 2022-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k210419-bioteq-drainage-catheter-bt-pds-series-fda-510k.jpg K210419 - BIOTEQ Drainage Catheter BT-PDS-series K210419 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Bioteque Corporation. Cleared Apr 2022. https://www.510kdatabase.net/k210634/ 2022-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k210634-mcl-31-dermablate-system-fda-510k.jpg K210634 - MCL 31 Dermablate System K210634 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Asclepion Laser Technologies GmbH. Cleared Apr 2022. https://www.510kdatabase.net/k211090/ 2022-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k211090-zenex-implant-system-fda-510k.jpg K211090 - ZENEX Implant System K211090 is a FDA 510(k) cleared dental medical device. Manufacturer: Izenimplant Co., Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k212202/ 2022-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k212202-wiscope-digital-cystoscope-system-fda-510k.jpg K212202 - WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System K212202 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: OTU Medical, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k212245/ 2022-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k212245-spine-and-trauma-navigation-system-fda-510k.jpg K212245 - Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument Selection, Fluoro 3D, Registration Software Fluoro 3D, Registration Software Paired Point, Registration Software Spine Surface Matching, Spine Planning, Elements Screw Planning Spine, Elements Spine Screw Planning K212245 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Brainlab AG. Cleared Apr 2022. https://www.510kdatabase.net/k212260/ 2022-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k212260-sensuva-premium-silicone-personal-fda-510k.jpg K212260 - Sensuva Premium Silicone Personal Lubricant K212260 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Valencia Naturals, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k213133/ 2022-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k213133-keffort-mc-100-mc-100a-fda-510k.jpg K213133 - Keffort (MC-100, MC-100A) K213133 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Oriental Inspiration Limited. Cleared Apr 2022. https://www.510kdatabase.net/k213181/ 2022-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k213181-carescape-b650-e-musb-fda-510k.jpg K213181 - CARESCAPE B650, E-musb K213181 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: GE Healthcare Finland Oy. Cleared Apr 2022. https://www.510kdatabase.net/k213336/ 2022-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k213336-carescape-b850-e-musb-fda-510k.jpg K213336 - Carescape B850, E-musb K213336 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: GE Healthcare Finland Oy. Cleared Apr 2022. https://www.510kdatabase.net/k213363/ 2022-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k213363-carescape-b450-e-musb-fda-510k.jpg K213363 - CARESCAPE B450, E-musb K213363 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: GE Healthcare Finland Oy. Cleared Apr 2022. https://www.510kdatabase.net/k214051/ 2022-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k214051-neodent-implant-system-helix-ngm-fda-510k.jpg K214051 - Neodent Implant System-Helix NGM Compact Surgical Kit Cases K214051 is a FDA 510(k) cleared general hospital medical device. Manufacturer: JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A.. Cleared Apr 2022. https://www.510kdatabase.net/k220373/ 2022-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k220373-get-a-griprescue-grip-nitrile-two-fda-510k.jpg K220373 - Get-A-Grip/Rescue-Grip, Nitrile Two Toned Black/Green, Diamond Grip Technology, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Grade Exam Gloves, Tested for Use with Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit) K220373 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Summit Glove, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k220375/ 2022-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k220375-intercept-free-nitrile-two-toned-fda-510k.jpg K220375 - Intercept Free, Nitrile Two Toned White/Green, Textured Fingertips, Powder-Free, Non-sterile, Ambidextrous, Beaded Cuff, Medical Examination Gloves, Tested for Use with Opioids Fentanyl citrate, Heroin, and both Opioids in simulated Gastric Acid (Vomit) K220375 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Summit Glove, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k220556/ 2022-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k220556-opensensorx-series-fda-510k.jpg K220556 - OpenSensorX Series K220556 is a FDA 510(k) cleared radiology medical device. Manufacturer: Dentimax, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k220773/ 2022-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k220773-everest-20-inflation-device-and-3-way-fda-510k.jpg K220773 - Everest 20 Inflation Device and 3-way Stopcock (AC2200) K220773 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Apr 2022. https://www.510kdatabase.net/k212811/ 2022-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k212811-ti3z-lumbar-interbody-system-fda-510k.jpg K212811 - Ti3Z Lumbar Interbody System K212811 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zavation Medical Products, LLC. Cleared Apr 2022. https://www.510kdatabase.net/k213234/ 2022-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k213234-carescape-one-and-carescape-dock-f0-fda-510k.jpg K213234 - CARESCAPE ONE and CARESCAPE DOCK F0, Model Numbers MBZ323 and MFA101, CARESCAPE ECG, Model Number MKE101,CARESCAPE TEMP, Model Number MKT101, CARESCAPE PRES, Model Number MKP101, CARESCAPE SPO2, Model Numbers MKS101 and MKS201 K213234 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k213296/ 2022-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k213296-anprolene-steritest-rrbi-fda-510k.jpg K213296 - Anprolene SteriTest RRBI K213296 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Andersen Sterilizers, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k213398/ 2022-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k213398-embold-fibered-detachable-coil-system-fda-510k.jpg K213398 - EMBOLD Fibered Detachable Coil System K213398 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Apr 2022. https://www.510kdatabase.net/k213518/ 2022-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k213518-carescape-co2-microstream-parameter-fda-510k.jpg K213518 - CARESCAPE CO2 Microstream parameter K213518 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Covidien, LLC. Cleared Apr 2022. https://www.510kdatabase.net/k213557/ 2022-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k213557-finexel-fda-510k.jpg K213557 - Finexel K213557 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Snj Co., Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k213650/ 2022-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k213650-thermpix-thermovisual-camera-fda-510k.jpg K213650 - ThermPix Thermovisual Camera K213650 is a FDA 510(k) cleared radiology medical device. Manufacturer: Usa Therm, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k214010/ 2022-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k214010-anteralign-spinal-system-with-titan-fda-510k.jpg K214010 - Anteralign Spinal System with Titan nanoLOCK Surface Technology K214010 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA. Cleared Apr 2022. https://www.510kdatabase.net/k214025/ 2022-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k214025-prowler-select-lp-es-microcatheter-fda-510k.jpg K214025 - PROWLER SELECT LP ES Microcatheter K214025 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medos International SARL. Cleared Apr 2022. https://www.510kdatabase.net/k214040/ 2022-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k214040-clearpoint-array-system-version-11-fda-510k.jpg K214040 - ClearPoint Array System (version 1.1) K214040 is a FDA 510(k) cleared neurology medical device. Manufacturer: ClearPoint Neuro, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k214075/ 2022-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k214075-safety-blood-collection-infusion-set-fda-510k.jpg K214075 - Safety Blood Collection / Infusion Set (with/without needle holder), Blood Collection / Infusion Set (with/without needle holder) K214075 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k214088/ 2022-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k214088-disposable-surgical-gown-fda-510k.jpg K214088 - Disposable Surgical Gown K214088 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Weihai Hongyu Nonwoven Fabric Products Co., Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k220027/ 2022-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k220027-audion-et-dilation-system-fda-510k.jpg K220027 - Audion ET dilation system K220027 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Entellus Medical, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k220103/ 2022-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k220103-led-therapy-device-planar-ledplanar-fda-510k.jpg K220103 - LED Therapy Device (Planar LED/Planar LED mini) K220103 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Leaflife Technology Co., Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k220405/ 2022-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k220405-amis-k-long-fda-510k.jpg K220405 - Amis K Long K220405 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Apr 2022. https://www.510kdatabase.net/k212719/ 2022-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k212719-micro-catheter-and-guidewire-system-fda-510k.jpg K212719 - Micro Catheter and Guidewire System K212719 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Suzhou Hengrui Hongyuan Medical Co., Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k212881/ 2022-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k212881-intense-pulsed-light-ipl-system-fda-510k.jpg K212881 - Intense Pulsed Light (IPL) System K212881 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Fansizhe Science And Technology Co., Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k212962/ 2022-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k212962-trellis-si-joint-fusion-system-fda-510k.jpg K212962 - TRELLIS™ SI Joint Fusion System K212962 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthofundamentals, LLC. Cleared Apr 2022. https://www.510kdatabase.net/k213437/ 2022-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k213437-blue-non-sterile-powder-free-nitrile-fda-510k.jpg K213437 - Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims K213437 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Central Medicare Sdn Bhd. Cleared Apr 2022. https://www.510kdatabase.net/k213675/ 2022-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k213675-mp-reconstruction-system-fda-510k.jpg K213675 - MP Reconstruction System K213675 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Waldemar Link GmbH & Co. KG. Cleared Apr 2022. https://www.510kdatabase.net/k214107/ 2022-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k214107-xo-cross-coronary-support-catheter-fda-510k.jpg K214107 - XO CROSS CORONARY Support Catheter K214107 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Transit Scientific, LLC. Cleared Apr 2022. https://www.510kdatabase.net/k220121/ 2022-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k220121-non-sterile-nitrile-powder-free-fda-510k.jpg K220121 - Non Sterile Nitrile Powder Free Examination Gloves – Blue,Green, and Black K220121 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Aamedix Glove Sdn Bhd. Cleared Apr 2022. https://www.510kdatabase.net/k220158/ 2022-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k220158-g-eye-system-fda-510k.jpg K220158 - G-EYE System K220158 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Smart Medical Systems , Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k220209/ 2022-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k220209-powder-free-nitrile-examination-glove-fda-510k.jpg K220209 - Powder Free Nitrile Examination Glove, Non-sterile (Blue) K220209 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ksg Medicare Sdn. Bhd.. Cleared Apr 2022. https://www.510kdatabase.net/k220477/ 2022-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k220477-cellvizio-100-series-system-with-fda-510k.jpg K220477 - Cellvizio 100 series system with confocal Miniprobes K220477 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Mauna Kea Technologies. Cleared Apr 2022. https://www.510kdatabase.net/k220737/ 2022-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k220737-world-knee-vit-e-all-poly-tibial-fda-510k.jpg K220737 - World Knee Vit-E All-poly Tibial Inserts (CR, PS and UC), World Knee Vit-E Meniscal Inserts (CR, PS and UC) K220737 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Signature Orthopaedics Pty, Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k212929/ 2022-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k212929-nitrile-examination-gloves-fda-510k.jpg K212929 - Nitrile Examination Gloves K212929 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Watchtower Ppe Supplies, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k220401/ 2022-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k220401-pink-powder-free-nitrile-examination-fda-510k.jpg K220401 - Pink Powder Free Nitrile Examination Glove With Bubblegum Scented, Chemotherapy Drugs And Fentanyl Test Claim K220401 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Riverstone Resources Sdn Bhd. Cleared Apr 2022. https://www.510kdatabase.net/k202389/ 2022-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k202389-oxygen-concentrator-fda-510k.jpg K202389 - Oxygen Concentrator K202389 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Foshan Mic Medical Technology Co., Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k210109/ 2022-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k210109-visor2-system-fda-510k.jpg K210109 - visor2 system K210109 is a FDA 510(k) cleared neurology medical device. Manufacturer: Eemagine Medical Imaging Solutions GmbH. Cleared Apr 2022. https://www.510kdatabase.net/k212017/ 2022-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k212017-thermeo-system-fda-510k.jpg K212017 - Thermeo System K212017 is a FDA 510(k) cleared dental medical device. Manufacturer: Pro3dure Medical GmbH. Cleared Apr 2022. https://www.510kdatabase.net/k212274/ 2022-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k212274-int-contour-fda-510k.jpg K212274 - INT Contour K212274 is a FDA 510(k) cleared radiology medical device. Manufacturer: Carina Medical, LLC. Cleared Apr 2022. https://www.510kdatabase.net/k212309/ 2022-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k212309-non-sterile-powder-free-latex-fda-510k.jpg K212309 - Non-sterile, Powder-Free Latex Examination Glove K212309 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sri Trang Gloves (Thailand) Public Company Limited. Cleared Apr 2022. https://www.510kdatabase.net/k212372/ 2022-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k212372-fitbit-irregular-rhythm-notifications-fda-510k.jpg K212372 - Fitbit Irregular Rhythm Notifications K212372 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Fitbit, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k212882/ 2022-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k212882-scout-bx-delivery-system-fda-510k.jpg K212882 - SCOUT BX Delivery System K212882 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k213015/ 2022-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k213015-dora-disposable-av-fistula-needle-sets-fda-510k.jpg K213015 - DORA Disposable A.V. Fistula Needle Sets K213015 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Bain Medical Equipment (Guangzhou) Co., Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k213063/ 2022-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k213063-tlx-sras-and-tlx-gold-abutments-fda-510k.jpg K213063 - TLX SRAs and TLX Gold Abutments K213063 is a FDA 510(k) cleared dental medical device. Manufacturer: Institut Straumann AG. Cleared Apr 2022. https://www.510kdatabase.net/k213509/ 2022-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k213509-latex-examination-gloves-powder-free-fda-510k.jpg K213509 - Latex Examination Gloves, Powder Free K213509 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shandong Intco Medical Products Co, Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k213633/ 2022-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k213633-echelon-3000-45mm-stapler-echelon-3000-fda-510k.jpg K213633 - ECHELON 3000 45mm Stapler, ECHELON 3000 60mm Stapler K213633 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon Endo-Surgery, LLC. Cleared Apr 2022. https://www.510kdatabase.net/k213958/ 2022-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k213958-bioabsorbable-anchor-fda-510k.jpg K213958 - Bioabsorbable Anchor K213958 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Embody, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k220144/ 2022-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k220144-breast-bi-coil-set-055t-fda-510k.jpg K220144 - Breast BI Coil Set 0.55T K220144 is a FDA 510(k) cleared radiology medical device. Manufacturer: Noras Mri Products GmbH. Cleared Apr 2022. https://www.510kdatabase.net/k220192/ 2022-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k220192-vantage-galan-3t-mrt-3020-v80-with-fda-510k.jpg K220192 - Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR K220192 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Apr 2022. https://www.510kdatabase.net/k220490/ 2022-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k220490-imacor-zura-handheld-zhh-010-fda-510k.jpg K220490 - ImaCor Zura Handheld ZHH-010 K220490 is a FDA 510(k) cleared radiology medical device. Manufacturer: Imacor, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k220699/ 2022-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k220699-prestige-coil-system-fda-510k.jpg K220699 - Prestige Coil System K220699 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bait USA, LLC. Cleared Apr 2022. https://www.510kdatabase.net/k220724/ 2022-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k220724-cd-horizon-spinal-system-and-pass-lp-fda-510k.jpg K220724 - CD Horizon™ Spinal System and PASS LP™ Spinal System K220724 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medicrea International. Cleared Apr 2022. https://www.510kdatabase.net/k220809/ 2022-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k220809-drive-rail-system-fda-510k.jpg K220809 - Drive Rail System K220809 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OrthoPediatrics Corp.. Cleared Apr 2022. https://www.510kdatabase.net/k210860/ 2022-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k210860-comfort-guard-mask-level-1-comfort-fda-510k.jpg K210860 - Comfort Guard Mask, level 1, Comfort Guard Mask, level 3 K210860 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Gri-Alleset, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k211203/ 2022-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k211203-green-or-reprocessed-aquamantys-fda-510k.jpg K211203 - Green OR Reprocessed Aquamantys Bipolar Sealer K211203 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Green Or, LLC. Cleared Apr 2022. https://www.510kdatabase.net/k212069/ 2022-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k212069-corin-metafix-hip-stem-fda-510k.jpg K212069 - Corin MetaFix™ Hip Stem K212069 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corin U.S.A. Limited. Cleared Apr 2022. https://www.510kdatabase.net/k212203/ 2022-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k212203-dong-hai-xiang-surgical-mask-fda-510k.jpg K212203 - Dong Hai Xiang Surgical Mask K212203 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Taizhou Donghaixiang Protective Equipment Co., Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k212278/ 2022-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k212278-electrocardiograph-fda-510k.jpg K212278 - Electrocardiograph K212278 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edan Instruments, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k220287/ 2022-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k220287-invisalign-system-fda-510k.jpg K220287 - Invisalign System K220287 is a FDA 510(k) cleared dental medical device. Manufacturer: Align Technology, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k202106/ 2022-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k202106-plasmage-system-fda-510k.jpg K202106 - Plasmage System K202106 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Brera Medical, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k202534/ 2022-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k202534-mtm301-blood-glucose-and-ketone-fda-510k.jpg K202534 - MTM301 Blood Glucose and Ketone Monitoring System K202534 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Apex BioTechnology Corp.. Cleared Apr 2022. https://www.510kdatabase.net/k203783/ 2022-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k203783-claripulmo-fda-510k.jpg K203783 - ClariPulmo K203783 is a FDA 510(k) cleared radiology medical device. Manufacturer: Claripi, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k210593/ 2022-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k210593-onera-sleep-test-system-onera-sts-fda-510k.jpg K210593 - Onera Sleep Test System (Onera STS) K210593 is a FDA 510(k) cleared neurology medical device. Manufacturer: Onera B.V.. Cleared Apr 2022. https://www.510kdatabase.net/k210714/ 2022-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k210714-extended-reservoir-fda-510k.jpg K210714 - Extended Reservoir K210714 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Medtronic Minimed, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k213506/ 2022-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k213506-nb-1-sa-implant-system-fda-510k.jpg K213506 - NB 1 SA Implant System K213506 is a FDA 510(k) cleared dental medical device. Manufacturer: Arum Dentistry Co., Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k213578/ 2022-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k213578-balloon-dilatation-catheter-fda-510k.jpg K213578 - Balloon Dilatation Catheter K213578 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hangzhou AGS MedTech Co., Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k213809/ 2022-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k213809-3m-attest-super-rapid-steam-biological-fda-510k.jpg K213809 - 3M Attest Super Rapid Steam Biological Indicator, 3M Attest Super Rapid Steam Challenge Pack, 3M Attest Auto-reader, 3M Attest Mini Auto-reader K213809 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Apr 2022. https://www.510kdatabase.net/k214085/ 2022-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k214085-disposable-medical-mask-fda-510k.jpg K214085 - Disposable Medical Mask K214085 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hubei Wanli Protective Products Co., Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k214114/ 2022-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k214114-prodigy-thrombectomy-system-fda-510k.jpg K214114 - Prodigy Thrombectomy System K214114 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Truvic Medical, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k220625/ 2022-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k220625-altms-magnetic-stimulation-therapy-fda-510k.jpg K220625 - ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System K220625 is a FDA 510(k) cleared neurology medical device. Manufacturer: Remed Co., Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k220654/ 2022-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k220654-angioguard-xp-emboli-capture-guidewire-fda-510k.jpg K220654 - ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire K220654 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corporation. Cleared Apr 2022. https://www.510kdatabase.net/k200946/ 2022-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k200946-clever-forehead-thermometer-clever-fda-510k.jpg K200946 - Clever Forehead Thermometer / Clever Medical Forehead Thermometer (Model TD-1241) K200946 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Taidoc Technology Corporation. Cleared Apr 2022. https://www.510kdatabase.net/k212463/ 2022-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k212463-geistlich-bio-gide-geistlich-bio-gide-fda-510k.jpg K212463 - Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen and Geistlich Perio-System Combi Pack K212463 is a FDA 510(k) cleared dental medical device. Manufacturer: Geistlich Pharma AG. Cleared Apr 2022. https://www.510kdatabase.net/k212601/ 2022-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k212601-drpx-locking-distal-radius-plate-system-fda-510k.jpg K212601 - DRPx Locking Distal Radius Plate System K212601 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthopaedic Implant Company. Cleared Apr 2022. https://www.510kdatabase.net/k213011/ 2022-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k213011-infrared-thermometer-model-e201-fda-510k.jpg K213011 - Infrared Thermometer (model: E201) K213011 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bioland Technology, Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k213450/ 2022-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k213450-medical-surgical-mask-black-mask-level-fda-510k.jpg K213450 - Medical surgical mask (Black mask, Level 1 and Level 3) K213450 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guangdong Kingfa Sci. & Tech.Co., Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k213560/ 2022-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k213560-verifine-safety-syringe-with-fixed-fda-510k.jpg K213560 - Verifine Safety Syringe with Fixed Needle K213560 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Promisemed Hangzhou Meditech Co., Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k213746/ 2022-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k213746-digital-thermometer-model-dt101-dt102-fda-510k.jpg K213746 - Digital thermometer, Model DT101, DT102 K213746 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guangzhou Berrcom Medical Device Co., Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k213783/ 2022-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k213783-apyx-fda-510k.jpg K213783 - Apyx K213783 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Escala Medical. Cleared Apr 2022. https://www.510kdatabase.net/k213808/ 2022-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k213808-co-innovation-one-step-human-chorionic-fda-510k.jpg K213808 - Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Strip, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Cassette, Co-Innovation One Step Human Chorionic Gonadotropin (HCG) Test Midstream K213808 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Co-Innovation Biotech Co., Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k214081/ 2022-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k214081-mrcat-head-neck-fda-510k.jpg K214081 - MRCAT Head & Neck K214081 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips OY. Cleared Apr 2022. https://www.510kdatabase.net/k220043/ 2022-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k220043-hera-w10-diagnostic-ultrasound-system-fda-510k.jpg K220043 - HERA W10 Diagnostic Ultrasound System, HERA W9 Diagnostic Ultrasound System K220043 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Medison Co., Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k220335/ 2022-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k220335-vantage-fortianorian-15t-mrt-1550-v80-fda-510k.jpg K220335 - Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR K220335 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Apr 2022. https://www.510kdatabase.net/k220364/ 2022-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k220364-accu-chek-safe-t-pro-uno-lancing-device-fda-510k.jpg K220364 - Accu-Chek Safe-T-Pro Uno Lancing Device K220364 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Roche Diabetes Care, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k212126/ 2022-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k212126-mediexpand-cervical-expandable-vbr-fda-510k.jpg K212126 - MediExpand Cervical Expandable VBR System K212126 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Cmf Medicon Surgical, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k212624/ 2022-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k212624-efai-intelligent-cardiothoracic-ratio-fda-510k.jpg K212624 - EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System K212624 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ever Fortune.Ai, Co., Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k213282/ 2022-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k213282-eri-handheld-dental-x-ray-system-model-fda-510k.jpg K213282 - ERI Handheld Dental X-ray System (Model AG100) K213282 is a FDA 510(k) cleared radiology medical device. Manufacturer: Energy Resources International Co., Ltd. Hsinchu Branch. Cleared Apr 2022. https://www.510kdatabase.net/k213388/ 2022-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k213388-alphavac-multipurpose-mechanical-fda-510k.jpg K213388 - AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System K213388 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: AngioDynamics, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k214006/ 2022-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k214006-invictus-spinal-fixation-system-fda-510k.jpg K214006 - Invictus® Spinal Fixation System K214006 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k220022/ 2022-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k220022-trate-dental-implant-system-fda-510k.jpg K220022 - TRATE Dental Implant System K220022 is a FDA 510(k) cleared dental medical device. Manufacturer: Trate AG. Cleared Apr 2022. https://www.510kdatabase.net/k213604/ 2022-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k213604-elaz-nitrile-powder-free-examination-fda-510k.jpg K213604 - ELAZ Nitrile Powder Free Examination Glove K213604 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Protect Gloves Co., Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k220066/ 2022-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k220066-medical-nitrile-examination-gloves-fda-510k.jpg K220066 - Medical Nitrile Examination Gloves K220066 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hunan Zhenheyikang Medical Instrument Co., Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k212947/ 2022-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k212947-trinity-plus-wrinkle-reducer-fda-510k.jpg K212947 - Trinity Plus Wrinkle Reducer K212947 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Carol Cole Company Dba Nuface. Cleared Apr 2022. https://www.510kdatabase.net/k220343/ 2022-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k220343-nitrile-examination-gloves-fda-510k.jpg K220343 - Nitrile Examination Gloves K220343 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Nb Medical Co., Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k210052/ 2022-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k210052-saneso-colonoscope-360-a-model-fda-510k.jpg K210052 - Saneso Colonoscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Colonoscope-A (Model: with/without Select Band Imaging (SBI)), Saneso Gastroscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Gastroscope-A (Model: with/without Select Band Imaging (SBI)) K210052 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Saneso, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k210558/ 2022-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k210558-liteaire-basic-dual-valved-collapsible-fda-510k.jpg K210558 - LiteAire Basic Dual-Valved, Collapsible MDI Holding Chamber K210558 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Thayer Medical Corporation. Cleared Apr 2022. https://www.510kdatabase.net/k211882/ 2022-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k211882-hd-550-video-endoscope-system-fda-510k.jpg K211882 - HD-550 Video Endoscope System K211882 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Sonoscape Medical Corp.. Cleared Apr 2022. https://www.510kdatabase.net/k212184/ 2022-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k212184-tens-and-ems-stimulation-otc-fda-510k.jpg K212184 - TENS and EMS Stimulation (OTC) K212184 is a FDA 510(k) cleared neurology medical device. Manufacturer: Changsha Yuwen Medical Equipment Co., Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k212216/ 2022-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k212216-prismaflex-st60-set-prismaflex-st100-fda-510k.jpg K212216 - Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set K212216 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corporation. Cleared Apr 2022. https://www.510kdatabase.net/k212392/ 2022-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k212392-intri24-sheath-fda-510k.jpg K212392 - Intri24 Sheath K212392 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inari Medical, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k213118/ 2022-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k213118-dakota-alif-system-fda-510k.jpg K213118 - Dakota ALIF System K213118 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Precision Spine, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k213432/ 2022-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k213432-mis-angulated-multi-unit-abutments-fda-510k.jpg K213432 - MIS Angulated multi-unit abutments K213432 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona. Cleared Apr 2022. https://www.510kdatabase.net/k213490/ 2022-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k213490-monitor-b105m-monitor-b125m-monitor-fda-510k.jpg K213490 - Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P K213490 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k213494/ 2022-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k213494-aveir-retrieval-catheter-fda-510k.jpg K213494 - Aveir Retrieval Catheter K213494 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared Apr 2022. https://www.510kdatabase.net/k213552/ 2022-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k213552-purastat-rm-fda-510k.jpg K213552 - PuraStat-RM K213552 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: 3-D Matrix, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k213657/ 2022-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k213657-deepvessel-ffr-fda-510k.jpg K213657 - DEEPVESSEL FFR K213657 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Keyamed Na, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k213793/ 2022-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k213793-empowr-revision-knee-fda-510k.jpg K213793 - EMPOWR Revision Knee K213793 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Encore Medical, L.P.. Cleared Apr 2022. https://www.510kdatabase.net/k220005/ 2022-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k220005-tens-pms-unit-fda-510k.jpg K220005 - TENS & PMS Unit K220005 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Yuehua Xinsen Technology Co., Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k220151/ 2022-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k220151-magnetom-avanto-fit-fda-510k.jpg K220151 - MAGNETOM Avanto Fit K220151 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 2022. https://www.510kdatabase.net/k220518/ 2022-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k220518-skanrad-400-fda-510k.jpg K220518 - SKANRAD 400 K220518 is a FDA 510(k) cleared radiology medical device. Manufacturer: Skanray Technologies Limited. Cleared Apr 2022. https://www.510kdatabase.net/k220601/ 2022-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k220601-cooltone-fda-510k.jpg K220601 - CoolTone K220601 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zimmer Medizinsysteme GmbH. Cleared Apr 2022. https://www.510kdatabase.net/k220668/ 2022-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k220668-wireless-digital-flat-panel-detector-fda-510k.jpg K220668 - Wireless Digital Flat Panel Detector K220668 is a FDA 510(k) cleared radiology medical device. Manufacturer: Iray Technology Taicang , Ltd.. Cleared Apr 2022. https://www.510kdatabase.net/k210546/ 2022-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k210546-elecsys-probnp-ii-elecsys-probnp-ii-stat-fda-510k.jpg K210546 - Elecsys proBNP II, Elecsys proBNP II STAT K210546 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Mar 2022. https://www.510kdatabase.net/k211043/ 2022-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k211043-alexis-contained-extraction-system-fda-510k.jpg K211043 - Alexis Contained Extraction System K211043 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Applied Medical Resources Corporation. Cleared Mar 2022. https://www.510kdatabase.net/k211120/ 2022-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k211120-eric-retrieval-device-fda-510k.jpg K211120 - ERIC Retrieval Device K211120 is a FDA 510(k) cleared neurology medical device. Manufacturer: MicroVention, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k212888/ 2022-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k212888-golnit-nylon-monofilament-suture-fda-510k.jpg K212888 - Golnit Nylon Monofilament Suture K212888 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Antarma, LLC Dba Golnit Sutures. Cleared Mar 2022. https://www.510kdatabase.net/k212894/ 2022-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k212894-phastipp-fda-510k.jpg K212894 - PhasTIPP K212894 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: LeMaitre Vascular, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k213736/ 2022-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k213736-medical-face-mask-fda-510k.jpg K213736 - Medical Face Mask K213736 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hangzhou Runheng Medical Co., Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k213745/ 2022-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k213745-air-compression-therapy-device-model-fda-510k.jpg K213745 - Air Compression Therapy Device, model: ST-502 K213745 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Shenzhen Future Electronic Co., Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k213843/ 2022-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k213843-nitrile-examination-gloves-fda-510k.jpg K213843 - Nitrile Examination Gloves K213843 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Dong Tai City Huayi Gloves Co., Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k214057/ 2022-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k214057-statim-6000b-vacuum-autoclave-fda-510k.jpg K214057 - STATIM 6000B Vacuum Autoclave K214057 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Scican , Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k220025/ 2022-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k220025-arx-spinal-system-fda-510k.jpg K220025 - ARx® Spinal System K220025 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k220160/ 2022-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k220160-pediguard-threaded-fda-510k.jpg K220160 - PediGuard Threaded K220160 is a FDA 510(k) cleared neurology medical device. Manufacturer: Spineguard S.A.. Cleared Mar 2022. https://www.510kdatabase.net/k220202/ 2022-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k220202-uterine-elevator-pro-with-occludor-fda-510k.jpg K220202 - Uterine ElevatOR PRO with OccludOR Balloon K220202 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: The O R Company Pty, Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k220240/ 2022-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k220240-vinyl-co-polymer-powder-free-fda-510k.jpg K220240 - Vinyl Co-Polymer Powder-free Examination Gloves, Black K220240 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Grand Work Plastic Products Co., Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k220260/ 2022-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k220260-hercules-syndesmosis-implant-system-fda-510k.jpg K220260 - Hercules Syndesmosis Implant System K220260 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: In2bones USA, LLC. Cleared Mar 2022. https://www.510kdatabase.net/k220291/ 2022-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k220291-nexxt-spine-navigation-system-fda-510k.jpg K220291 - NEXXT SPINE NAVIGATION System K220291 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nexxt Spine, LLC. Cleared Mar 2022. https://www.510kdatabase.net/k220353/ 2022-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k220353-disposal-medical-nitrile-examination-fda-510k.jpg K220353 - Disposal Medical Nitrile Examination Gloves-Tested for Use with Chemotherapy Drugs K220353 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Niujian Technology Co., Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k220584/ 2022-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k220584-bd-cathena-safety-iv-catheter-fda-510k.jpg K220584 - BD Cathena Safety IV Catheter K220584 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton Dickinson Infusion Therapy Systems, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k220674/ 2022-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k220674-targetcool-fda-510k.jpg K220674 - TargetCool K220674 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Recensmedical, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k220678/ 2022-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k220678-apx-24-portable-x-ray-system-fda-510k.jpg K220678 - APX-24 Portable X-ray System K220678 is a FDA 510(k) cleared radiology medical device. Manufacturer: Aspenstate, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k210422/ 2022-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k210422-intai-surgical-mask-non-sterile-fda-510k.jpg K210422 - INTAI Surgical Mask (non-sterile) K210422 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Intai Technology Corp.. Cleared Mar 2022. https://www.510kdatabase.net/k211681/ 2022-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k211681-eon-fda-510k.jpg K211681 - EON K211681 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Dominion Aesthetic Technologies, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k212159/ 2022-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k212159-shield-system-fda-510k.jpg K212159 - Shield System K212159 is a FDA 510(k) cleared radiology medical device. Manufacturer: Radiaction , Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k212464/ 2022-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k212464-dukal-corporation-aami-level-4-open-fda-510k.jpg K212464 - Dukal Corporation AAMI Level 4 Open-Back Protective Gown K212464 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Dukal Corporation. Cleared Mar 2022. https://www.510kdatabase.net/k213370/ 2022-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k213370-veriqa-fda-510k.jpg K213370 - VERIQA K213370 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ptw-Freiburg Physikalisch-Technische-Werkstaetten. Cleared Mar 2022. https://www.510kdatabase.net/k213699/ 2022-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k213699-caretaker-monitor-app-fda-510k.jpg K213699 - CareTaker Monitor App K213699 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Caretaker Medical, LLC. Cleared Mar 2022. https://www.510kdatabase.net/k213896/ 2022-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k213896-bd-trek-powered-bone-biopsy-system-fda-510k.jpg K213896 - BD Trek Powered Bone Biopsy System K213896 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bard Peripheral Vascular. Cleared Mar 2022. https://www.510kdatabase.net/k214047/ 2022-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k214047-el-capitan-anterior-lumbar-interbody-fda-510k.jpg K214047 - EL CAPITAN Anterior Lumbar Interbody Fusion System K214047 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Astura Medical. Cleared Mar 2022. https://www.510kdatabase.net/k214093/ 2022-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k214093-vsp-bolus-fda-510k.jpg K214093 - VSP Bolus K214093 is a FDA 510(k) cleared radiology medical device. Manufacturer: 3D Systems. Cleared Mar 2022. https://www.510kdatabase.net/k220182/ 2022-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k220182-aggeris-c-fda-510k.jpg K220182 - Aggeris™-C K220182 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Clariance. Cleared Mar 2022. https://www.510kdatabase.net/k220213/ 2022-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k220213-empulse-r90-fda-510k.jpg K220213 - Empulse R90 K220213 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Sunrise Medical (Us), LLC. Cleared Mar 2022. https://www.510kdatabase.net/k202266/ 2022-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k202266-reliance-cervical-ibf-system-fda-510k.jpg K202266 - Reliance Cervical IBF System K202266 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Reliance Medical Systems, LLC. Cleared Mar 2022. https://www.510kdatabase.net/k210321/ 2022-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k210321-dukal-corporation-level-1-pediatric-fda-510k.jpg K210321 - Dukal Corporation Level 1 Pediatric Face Mask K210321 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Dukal Corporation. Cleared Mar 2022. https://www.510kdatabase.net/k213529/ 2022-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k213529-focus-hd-43-detector-fda-510k.jpg K213529 - Focus HD 43 Detector K213529 is a FDA 510(k) cleared radiology medical device. Manufacturer: Iray Technology Taicang , Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k213646/ 2022-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k213646-focus-hd-35-detector-fda-510k.jpg K213646 - Focus HD 35 Detector K213646 is a FDA 510(k) cleared radiology medical device. Manufacturer: Iray Technology Taicang , Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k213887/ 2022-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k213887-gal-1a-plus-blood-glucose-monitoring-fda-510k.jpg K213887 - GAL-1A Plus Blood Glucose Monitoring System K213887 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Apex BioTechnology Corp.. Cleared Mar 2022. https://www.510kdatabase.net/k220247/ 2022-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k220247-guidewire-locking-device-fda-510k.jpg K220247 - Guidewire Locking Device K220247 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Micro-Tech (Nanjing) Co., Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k220255/ 2022-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k220255-real-intelligence-cori-fda-510k.jpg K220255 - REAL INTELLIGENCE CORI K220255 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Blue Belt Technologies, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/den200042/ 2022-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/den200042-braintemp-neonate-system-btneo-system-fda-510k.jpg DEN200042 - BrainTemp Neonate System (BTNeo System) DEN200042 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brain Temp, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k212037/ 2022-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k212037-sancdam-latex-oral-dam-fda-510k.jpg K212037 - SancDam Latex Oral Dam K212037 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Sanctuary Health Sdn. Bhd.. Cleared Mar 2022. https://www.510kdatabase.net/k212889/ 2022-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k212889-syngoct-dual-energy-fda-510k.jpg K212889 - Syngo.CT Dual Energy K212889 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k213147/ 2022-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k213147-cerabien-milai-fda-510k.jpg K213147 - CERABIEN MiLai K213147 is a FDA 510(k) cleared dental medical device. Manufacturer: Kuraray Noritake Dental, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k213415/ 2022-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k213415-ossiofiber-suture-anchor-fda-510k.jpg K213415 - OSSIOfiber Suture Anchor K213415 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OSSIO , Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k213662/ 2022-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k213662-disposable-nitrile-rubber-protective-fda-510k.jpg K213662 - Disposable nitrile rubber protective gloves (Tested for Use with Chemotherapy Drugs) K213662 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Taishan Weibang Medical Equipment Co., Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k213672/ 2022-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k213672-t3-pro-implants-fda-510k.jpg K213672 - T3 Pro Implants K213672 is a FDA 510(k) cleared dental medical device. Manufacturer: Biomet 3i, LLC. Cleared Mar 2022. https://www.510kdatabase.net/k214113/ 2022-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k214113-hand-held-ipl-devicejovs-graphene-hair-fda-510k.jpg K214113 - Hand-held IPL device(JOVS Graphene Hair Removal Device) K214113 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Qianyu Technology Co., Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k210352/ 2022-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k210352-ggm-breathing-circuit-bacterial-filter-fda-510k.jpg K210352 - GGM Breathing Circuit Bacterial Filter K210352 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Great Group Medical Co, Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k213729/ 2022-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k213729-clover-glove-fda-510k.jpg K213729 - Clover Glove K213729 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Clover Glove Company Limited. Cleared Mar 2022. https://www.510kdatabase.net/k220215/ 2022-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k220215-powder-free-nitrile-examination-glove-fda-510k.jpg K220215 - Powder Free Nitrile Examination Glove, Non-sterile, Tested for Use with Chemotherapy Drugs, and the Opioid Fentanyl citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid (Blue) K220215 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ksg Medicare Sdn. Bhd.. Cleared Mar 2022. https://www.510kdatabase.net/k220229/ 2022-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k220229-powder-free-nitrile-examination-gloves-fda-510k.jpg K220229 - Powder Free Nitrile Examination Gloves, Orange K220229 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shanxi Hongjin Plastic Technology Co., Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k202437/ 2022-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k202437-infusion-sets-for-single-use-fda-510k.jpg K202437 - Infusion Sets for Single Use K202437 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Suyun Medical Materials Co., Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k210037/ 2022-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k210037-pluski-safe-1-safety-iv-catheter-fda-510k.jpg K210037 - Pluski Safe 1 Safety IV Catheter K210037 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Mediplus (India) Limited. Cleared Mar 2022. https://www.510kdatabase.net/k212153/ 2022-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k212153-biobeat-platform-bb-613wp-patch-fda-510k.jpg K212153 - Biobeat Platform, BB-613WP Patch K212153 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biobeat Technologies , Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k212231/ 2022-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k212231-c1210g-lcd-monitor-jusha-c1210g-lcd-fda-510k.jpg K212231 - C1210G LCD Monitor, JUSHA-C1210G LCD Monitor, C1210 LCD Monitor, JUSHA-C1210 LCD Monitor K212231 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nanjing Jusha Display Technology Co., Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k212263/ 2022-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k212263-luna-g3-bpap-system-fda-510k.jpg K212263 - Luna G3 BPAP System K212263 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: 3B Medical, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k212395/ 2022-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k212395-nebulizer-fda-510k.jpg K212395 - Nebulizer K212395 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Homed Medical Device Co., Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k213355/ 2022-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k213355-toro-l-interbody-fusion-system-fda-510k.jpg K213355 - Toro-L Interbody Fusion System K213355 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Integrity Implants, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k213562/ 2022-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k213562-dtx-studio-clinic-30-fda-510k.jpg K213562 - DTX Studio Clinic 3.0 K213562 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nobel Biocare AB. Cleared Mar 2022. https://www.510kdatabase.net/k213820/ 2022-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k213820-balteum-one-lumbar-plate-system-fda-510k.jpg K213820 - BALTEUM - ONE™ Lumbar Plate System K213820 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Huvexel Co. , Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k213848/ 2022-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k213848-medical-nitrile-examination-gloves-fda-510k.jpg K213848 - Medical nitrile examination gloves (Model: JL001) K213848 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guangdong Jiali Pharmaceutical Co.,Ltd. Cleared Mar 2022. https://www.510kdatabase.net/k220187/ 2022-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k220187-medical-surgical-mask-model-jm92-jm92b-fda-510k.jpg K220187 - Medical Surgical Mask (Model: JM92, JM92B) K220187 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guangdong Jia Mei Biological Technology Co.Ltd. Cleared Mar 2022. https://www.510kdatabase.net/k220242/ 2022-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k220242-tex20tex20-protex20stex20ttex20-fda-510k.jpg K220242 - TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System K220242 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k220362/ 2022-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k220362-le-12ch-fda-510k.jpg K220362 - LE-12CH K220362 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Caf Medical Solutions, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k220600/ 2022-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k220600-artix-thrombectomy-device-fda-510k.jpg K220600 - Artix Thrombectomy Device K220600 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inari Medical. Cleared Mar 2022. https://www.510kdatabase.net/k220637/ 2022-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k220637-3-ply-medical-grade-single-use-fda-510k.jpg K220637 - 3 Ply Medical Grade Single Use Procedural Disposable Face Mask K220637 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Kdi Med Supply. Cleared Mar 2022. https://www.510kdatabase.net/k202903/ 2022-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k202903-surgical-face-mask-fda-510k.jpg K202903 - Surgical Face Mask K202903 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Rizhao Sanqi Medical & Health Articles Co., Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k211365/ 2022-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k211365-alio-medical-remote-monitoring-system-fda-510k.jpg K211365 - Alio Medical Remote Monitoring System K211365 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Graftworx, Inc. Dba Alio. Cleared Mar 2022. https://www.510kdatabase.net/k212916/ 2022-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k212916-black-nitrile-powder-free-patient-fda-510k.jpg K212916 - Black Nitrile Powder Free Patient Examination Glove, Non Sterile K212916 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Rimba Glove Sdn Bhd. Cleared Mar 2022. https://www.510kdatabase.net/k213461/ 2022-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k213461-aviclear-laser-system-fda-510k.jpg K213461 - AviClear Laser System K213461 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cutera, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k213492/ 2022-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k213492-dib-ultranav-transseptal-catheter-system-fda-510k.jpg K213492 - Dib UltraNav Transseptal Catheter System K213492 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Dib Ultranav Medical, LLC. Cleared Mar 2022. https://www.510kdatabase.net/k213589/ 2022-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k213589-fubuki-xf-neurovascular-long-sheath-fda-510k.jpg K213589 - FUBUKI XF Neurovascular Long Sheath K213589 is a FDA 510(k) cleared neurology medical device. Manufacturer: Asahi Intecc Co., Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k220196/ 2022-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k220196-steth-io-spot-fda-510k.jpg K220196 - Steth IO Spot K220196 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Stratoscientific. Cleared Mar 2022. https://www.510kdatabase.net/k220206/ 2022-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k220206-mobility-scooter-fda-510k.jpg K220206 - Mobility Scooter K220206 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zhejiang Innuovo Rehabilitation Devices Co.,Ltd. Cleared Mar 2022. https://www.510kdatabase.net/k220207/ 2022-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k220207-mobility-scooter-model-w3468-fda-510k.jpg K220207 - Mobility Scooter, Model W3468 K220207 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zhejiang Innuovo Rehabilitation Devices Co.,Ltd. Cleared Mar 2022. https://www.510kdatabase.net/k220354/ 2022-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k220354-disposable-medical-synthetic-nitrile-fda-510k.jpg K220354 - Disposable Medical Synthetic Nitrile Examination Gloves K220354 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Niujian Technology Co., Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k220453/ 2022-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k220453-flarehawk-interbody-fusion-system-fda-510k.jpg K220453 - FlareHawk Interbody Fusion System K220453 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Integrity Implants, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k220519/ 2022-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k220519-erchonia-zerona-z-bed-fda-510k.jpg K220519 - Erchonia Zerona Z-Bed K220519 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Erchonia Corporation. Cleared Mar 2022. https://www.510kdatabase.net/k220629/ 2022-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k220629-emerge-monorail-ptca-dilatation-catheter-fda-510k.jpg K220629 - Emerge Monorail PTCA Dilatation Catheter K220629 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific. Cleared Mar 2022. https://www.510kdatabase.net/k220655/ 2022-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k220655-x-pac-expandable-lumbar-cage-system-fda-510k.jpg K220655 - X-Pac Expandable Lumbar Cage System K220655 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Expanding Innovations, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k210718/ 2022-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k210718-luofucon-extra-silver-gelling-fiber-fda-510k.jpg K210718 - LUOFUCON Extra Silver Gelling Fiber Dressing, LUOFUCON Silver Antibacterial Gelling Fiber Dressing K210718 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Huizhou Foryou Medical Devices Co., Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k212625/ 2022-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k212625-pathbuilder-transseptal-needle-fda-510k.jpg K212625 - PathBuilder Transseptal Needle K212625 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shanghai Microport EP Medtech Co., Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k212626/ 2022-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k212626-pathbuilder-transseptal-guiding-fda-510k.jpg K212626 - PathBuilder Transseptal Guiding Introducer K212626 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shanghai Microport EP Medtech Co., Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k212726/ 2022-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k212726-disposable-medical-surgical-mask-fda-510k.jpg K212726 - Disposable Medical Surgical Mask K212726 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hubei Huaqiang High-Tech Co., Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k213568/ 2022-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k213568-drx-rise-mobile-x-ray-system-fda-510k.jpg K213568 - DRX-Rise Mobile X-ray System K213568 is a FDA 510(k) cleared radiology medical device. Manufacturer: Carestream Health. Cleared Mar 2022. https://www.510kdatabase.net/k213592/ 2022-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k213592-iridex-810-laser-fda-510k.jpg K213592 - Iridex 810 Laser K213592 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Iridex Corporation. Cleared Mar 2022. https://www.510kdatabase.net/k213616/ 2022-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k213616-bd-surgiphor-antimicrobial-irrigation-fda-510k.jpg K213616 - BD Surgiphor Antimicrobial Irrigation System K213616 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Becton, Dickinson and Company. Cleared Mar 2022. https://www.510kdatabase.net/k213860/ 2022-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k213860-arthrofree-wireless-surgical-camera-fda-510k.jpg K213860 - ArthroFree Wireless Surgical Camera System K213860 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lazurite Holdings, LLC. Cleared Mar 2022. https://www.510kdatabase.net/k214101/ 2022-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k214101-project-e-beauty-led-light-therapy-fda-510k.jpg K214101 - Project E Beauty LED Light Therapy Mask (Model: PE730) K214101 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Duplex International Trading Limited. Cleared Mar 2022. https://www.510kdatabase.net/k220178/ 2022-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k220178-total-immunoglobulin-e-ige-fda-510k.jpg K220178 - Total Immunoglobulin E (IgE) K220178 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k220492/ 2022-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k220492-copal-exchange-g-hip-spacer-fda-510k.jpg K220492 - COPAL exchange G hip spacer K220492 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Heraeus Medical GmbH. Cleared Mar 2022. https://www.510kdatabase.net/k220501/ 2022-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k220501-pounce-thrombectomy-system-fda-510k.jpg K220501 - Pounce Thrombectomy System K220501 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Surmodics,Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k200828/ 2022-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k200828-athelas-home-fda-510k.jpg K200828 - Athelas Home K200828 is a FDA 510(k) cleared hematology medical device. Manufacturer: Athelas, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k210452/ 2022-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k210452-creatinine2-fda-510k.jpg K210452 - Creatinine2 K210452 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Ireland Diagnostics Division. Cleared Mar 2022. https://www.510kdatabase.net/k210693/ 2022-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k210693-plexr-plus-fda-510k.jpg K210693 - PLEXR PLUS K210693 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Gmv S.R.L.. Cleared Mar 2022. https://www.510kdatabase.net/k212960/ 2022-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k212960-aplio-a550-aplio-a450-and-aplio-a-fda-510k.jpg K212960 - Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Software V6.5 K212960 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Mar 2022. https://www.510kdatabase.net/k213522/ 2022-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k213522-amsafe-pre-filled-normal-saline-flush-fda-510k.jpg K213522 - AMSafe Pre-Filled Normal Saline Flush Syringe K213522 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Amsino International, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k213678/ 2022-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k213678-powder-free-blue-nitrile-examination-fda-510k.jpg K213678 - Powder Free Blue Nitrile Examination Gloves K213678 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Lienteh Technology Sdn Bhd. Cleared Mar 2022. https://www.510kdatabase.net/k214039/ 2022-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k214039-logiq-p10-logiq-p9-logiq-p8-fda-510k.jpg K214039 - LOGIQ P10, LOGIQ P9, LOGIQ P8 K214039 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared Mar 2022. https://www.510kdatabase.net/k214103/ 2022-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k214103-shani-darden-led-light-therapy-mask-fda-510k.jpg K214103 - Shani Darden LED light therapy mask K214103 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Harpar Grace International. Cleared Mar 2022. https://www.510kdatabase.net/k220181/ 2022-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k220181-stealthfix-intraosseous-fixation-system-fda-510k.jpg K220181 - StealthFix Intraosseous Fixation System K220181 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nextremity Solutions, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k220511/ 2022-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k220511-medline-unite-im-fibula-implant-fda-510k.jpg K220511 - Medline UNITE IM Fibula Implant K220511 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medline Industries, LP. Cleared Mar 2022. https://www.510kdatabase.net/k203839/ 2022-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k203839-watchpat200u-wp200u-fda-510k.jpg K203839 - WatchPAT200U (WP200U) K203839 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Itamar Medical , Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k212999/ 2022-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k212999-multi-functional-electrosurgical-knife-fda-510k.jpg K212999 - Multi-Functional Electrosurgical Knife K212999 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Anrei Medical (Hangzhou) Co., Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k213200/ 2022-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k213200-solus-gold-embolization-device-fda-510k.jpg K213200 - Solus Gold Embolization Device K213200 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Artio Medical, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k213246/ 2022-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k213246-nim-surgeon-control-probe-prass-tip-fda-510k.jpg K213246 - NIM Surgeon Control Probe, Prass Tip, NIM Surgeon Control Probe, 1mm Ball Tip, NIM Surgeon Control Probe, 1mm Ball Tip, 35cm Long K213246 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Medtronic Xomed, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k213721/ 2022-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k213721-briefcase-fda-510k.jpg K213721 - BriefCase K213721 is a FDA 510(k) cleared radiology medical device. Manufacturer: Aidoc Medical , Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k220199/ 2022-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k220199-affinity-proximal-tibia-system-fda-510k.jpg K220199 - AFFINITY Proximal Tibia System K220199 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Techfit Digital Surgery, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k203237/ 2022-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k203237-dukal-sterile-aami-level-3-reinforced-fda-510k.jpg K203237 - Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown K203237 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Dukal Corporation. Cleared Mar 2022. https://www.510kdatabase.net/k203530/ 2022-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k203530-albumin-bcp2-fda-510k.jpg K203530 - Albumin BCP2 K203530 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Ireland Diagnostics Division. Cleared Mar 2022. https://www.510kdatabase.net/k210171/ 2022-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k210171-non-contact-infrared-thermometer-fda-510k.jpg K210171 - Non-contact Infrared Thermometer (Models WL-301, WL-501, WL-601, WL-701) K210171 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sichuan Youkede Medical Equipment Co.,Ltd. Cleared Mar 2022. https://www.510kdatabase.net/k210823/ 2022-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k210823-lyma-laser-fda-510k.jpg K210823 - LYMA Laser K210823 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lyma Life , Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k211132/ 2022-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k211132-ariste-ab-mesh-fda-510k.jpg K211132 - ARISTE AB Mesh K211132 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ariste Medical, LLC. Cleared Mar 2022. https://www.510kdatabase.net/k211438/ 2022-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k211438-optrell-mapping-catheter-with-trueref-fda-510k.jpg K211438 - OPTRELL Mapping Catheter with TRUEref Technology K211438 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biosense Webster, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k212371/ 2022-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k212371-fp-evora-full-face-mask-fda-510k.jpg K212371 - F&P Evora Full Face Mask K212371 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Fisher &Paykel Healthcare , Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k212498/ 2022-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k212498-stable-l-standalone-lumbar-interbody-fda-510k.jpg K212498 - Stable-L Standalone Lumbar Interbody System K212498 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nexus Spine, LLC. Cleared Mar 2022. https://www.510kdatabase.net/k212891/ 2022-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k212891-tempsure-system-fda-510k.jpg K212891 - TempSure System K212891 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cynosure, LLC. Cleared Mar 2022. https://www.510kdatabase.net/k212939/ 2022-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k212939-vintage-prime-press-fda-510k.jpg K212939 - Vintage Prime Press K212939 is a FDA 510(k) cleared dental medical device. Manufacturer: Shofu Dental Corporation. Cleared Mar 2022. https://www.510kdatabase.net/k213563/ 2022-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k213563-depuy-synthes-radial-head-replacement-fda-510k.jpg K213563 - DePuy Synthes Radial Head Replacement System K213563 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Synthes. Cleared Mar 2022. https://www.510kdatabase.net/k213834/ 2022-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k213834-cardio-flow-peripheral-guide-wire-fda-510k.jpg K213834 - Cardio Flow Peripheral Guide Wire K213834 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cardio Flow Inc.,. Cleared Mar 2022. https://www.510kdatabase.net/k213965/ 2022-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k213965-beautibond-xtreme-fda-510k.jpg K213965 - BeautiBond Xtreme K213965 is a FDA 510(k) cleared dental medical device. Manufacturer: Shofu Dental Corporation. Cleared Mar 2022. https://www.510kdatabase.net/k214016/ 2022-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k214016-15l-cycler-drainage-bag-fda-510k.jpg K214016 - 15L Cycler Drainage Bag K214016 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corporation. Cleared Mar 2022. https://www.510kdatabase.net/k220153/ 2022-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k220153-needle-stimulator-model-rjns6-1-fda-510k.jpg K220153 - Needle Stimulator (Model: RJNS6-1) K220153 is a FDA 510(k) cleared neurology medical device. Manufacturer: Bozhou Rongjian Medical Appliance Co., Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k220228/ 2022-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k220228-powder-free-nitrile-examination-gloves-fda-510k.jpg K220228 - Powder Free Nitrile Examination Gloves, Blue and Violet Blue, Test For Use With Chemotherapy Drugs K220228 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shandong Blue Sail Health Technology Co., Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k220275/ 2022-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k220275-emerge-anterior-cervical-plate-system-fda-510k.jpg K220275 - EMERGE Anterior Cervical Plate System K220275 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Evolution Spine. Cleared Mar 2022. https://www.510kdatabase.net/k220473/ 2022-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k220473-celerity-20-hp-challenge-pack-fda-510k.jpg K220473 - CELERITY 20 HP Challenge Pack K220473 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Steris. Cleared Mar 2022. https://www.510kdatabase.net/k220529/ 2022-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k220529-merits-p335-powered-wheelchair-fda-510k.jpg K220529 - Merits P335 Powered Wheelchair K220529 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Merits Health Products Co., Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k220627/ 2022-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k220627-surgivisio-device-fda-510k.jpg K220627 - SURGIVISIO Device K220627 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ecential Robotics. Cleared Mar 2022. https://www.510kdatabase.net/k210315/ 2022-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k210315-single-use-hand-switch-monopolar-fda-510k.jpg K210315 - Single Use Hand Switch Monopolar Forceps with Smoke Evacuation, Single Use Hand Switch Bipolar Forceps with Smoke Evacuation, Single Use Hand Switch Monopolar Forceps, Single Use Hand Switch Bipolar Forceps K210315 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Modern Medical Equipment Manufacturing, Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k210489/ 2022-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k210489-sictapered-sicvantage-tapered-fda-510k.jpg K210489 - SICtapered & SICvantage tapered K210489 is a FDA 510(k) cleared dental medical device. Manufacturer: Sic Invent AG. Cleared Mar 2022. https://www.510kdatabase.net/k212631/ 2022-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k212631-optimum-infinite-tisilfocon-a-daily-fda-510k.jpg K212631 - Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses K212631 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Contamac, Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k213444/ 2022-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k213444-relief-ureteral-stent-kit-fda-510k.jpg K213444 - RELIEF Ureteral Stent Kit K213444 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ureteral Stent Company. Cleared Mar 2022. https://www.510kdatabase.net/k213948/ 2022-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k213948-oxyminder-fda-510k.jpg K213948 - OxyMinder K213948 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Bio-Med Devices, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k210528/ 2022-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k210528-intellifat-disposable-adipose-tissue-fda-510k.jpg K210528 - IntelliFat Disposable Adipose Tissue Harvesting and Transfer Kit, IntelliFat Body On Demand (BOD) Kit K210528 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Millennium Medical Technologies Inc (Dba Cellmyx). Cleared Mar 2022. https://www.510kdatabase.net/k212623/ 2022-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k212623-healgen-strep-a-rapid-test-strip-fda-510k.jpg K212623 - Healgen Strep A Rapid Test Strip (Throat Swab) K212623 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Healgen Scientific, LLC. Cleared Mar 2022. https://www.510kdatabase.net/k212851/ 2022-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k212851-echosk-and-echosgyn-modules-for-echos-fda-510k.jpg K212851 - EchoSK and EchoSGyn modules for EchoS Family devices K212851 is a FDA 510(k) cleared radiology medical device. Manufacturer: Echolight S.P.A. Cleared Mar 2022. https://www.510kdatabase.net/k213623/ 2022-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k213623-itear100-neurostimulator-fda-510k.jpg K213623 - iTEAR100 Neurostimulator K213623 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Olympic Ophthalmics. Cleared Mar 2022. https://www.510kdatabase.net/k213779/ 2022-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k213779-customize-fda-510k.jpg K213779 - Customize K213779 is a FDA 510(k) cleared radiology medical device. Manufacturer: 3D-Side S.A.. Cleared Mar 2022. https://www.510kdatabase.net/k213823/ 2022-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k213823-intera-refill-kit-fda-510k.jpg K213823 - Intera Refill Kit K213823 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Intera Oncology, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k220324/ 2022-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k220324-accufit-lateral-2-hole-plate-fda-510k.jpg K220324 - AccuFit Lateral 2-Hole Plate K220324 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Precision Spine, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k220426/ 2022-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k220426-fiber-dust-pro-fda-510k.jpg K220426 - Fiber Dust PRO K220426 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Quanta System Spa. Cleared Mar 2022. https://www.510kdatabase.net/k220726/ 2022-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k220726-k-clear-fda-510k.jpg K220726 - K Clear K220726 is a FDA 510(k) cleared dental medical device. Manufacturer: Kline Europe GmbH. Cleared Mar 2022. https://www.510kdatabase.net/k212461/ 2022-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k212461-vitek-ms-prime-fda-510k.jpg K212461 - VITEK MS PRIME K212461 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k212709/ 2022-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k212709-voqx-electronic-stethoscope-fda-510k.jpg K212709 - VoqX Electronic Stethoscope K212709 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sanolla , Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k212955/ 2022-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k212955-fit-pro-breast-pump-fda-510k.jpg K212955 - Fit Pro Breast Pump K212955 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Hygeia II Medical Group, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k213121/ 2022-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k213121-disposable-nitrile-examination-glove-fda-510k.jpg K213121 - Disposable Nitrile Examination Glove K213121 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Cureguard Glove Co., Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k213314/ 2022-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k213314-cerusendo-microcatheter-027-fda-510k.jpg K213314 - CerusEndo Microcatheter (027) K213314 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cerus Endovascular, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k213980/ 2022-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k213980-peridot-spinal-interbody-system-fda-510k.jpg K213980 - Peridot Spinal Interbody System K213980 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Gbs Commonwealth Co., Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k203738/ 2022-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k203738-qitexio-fda-510k.jpg K203738 - Qitexio K203738 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medex. Cleared Mar 2022. https://www.510kdatabase.net/k203744/ 2022-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k203744-arterys-mica-fda-510k.jpg K203744 - Arterys MICA K203744 is a FDA 510(k) cleared radiology medical device. Manufacturer: Arterys, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k211324/ 2022-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k211324-24mm-distal-radius-system-fda-510k.jpg K211324 - 2.4mm Distal Radius System K211324 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Auxein Medical Private Limited. Cleared Mar 2022. https://www.510kdatabase.net/k211420/ 2022-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k211420-stasis-gel-fda-510k.jpg K211420 - Stasis Gel K211420 is a FDA 510(k) cleared dental medical device. Manufacturer: Belport Company, Inc., Gingi-Pak. Cleared Mar 2022. https://www.510kdatabase.net/k212330/ 2022-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k212330-yadu-medical-face-mask-level-1-fda-510k.jpg K212330 - Yadu Medical Face Mask (Level 1) K212330 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Henan Yadu Industrial Co., Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k212393/ 2022-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k212393-opn-nc-ptca-dilatation-catheter-fda-510k.jpg K212393 - OPN NC PTCA Dilatation Catheter K212393 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sis Medical AG. Cleared Mar 2022. https://www.510kdatabase.net/k213790/ 2022-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k213790-aluminum-back-folding-wheelchair-syiv-fda-510k.jpg K213790 - Aluminum back folding wheelchair SYIV 100-LQXAL2482-407 K213790 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Mobility Source Medical Technology Co., Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k213894/ 2022-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k213894-dwfritz-asm2000-fda-510k.jpg K213894 - DWFritz ASM2000 K213894 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Dwfritz Automation, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k213907/ 2022-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k213907-careguard-sterilization-wrap-fda-510k.jpg K213907 - CareGUARD Sterilization Wrap K213907 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Care Essentials Pty, Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k214043/ 2022-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k214043-briefcase-fda-510k.jpg K214043 - BriefCase K214043 is a FDA 510(k) cleared radiology medical device. Manufacturer: Aidoc Medical , Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k220049/ 2022-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k220049-optimotion-implants-porous-metal-fda-510k.jpg K220049 - Optimotion Implants Porous Metal-Backed Patella K220049 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Optimotion Implants, LLC. Cleared Mar 2022. https://www.510kdatabase.net/k213806/ 2022-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k213806-disposable-medical-face-mask-fda-510k.jpg K213806 - Disposable Medical Face Mask K213806 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Xiantao Zhibo Nonwoven Products Co., Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k201229/ 2022-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k201229-intai-anatomic-locking-plate-and-screw-fda-510k.jpg K201229 - Intai Anatomic Locking Plate and Screw System K201229 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Intai Technology Corporation. Cleared Mar 2022. https://www.510kdatabase.net/k201351/ 2022-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k201351-maxima-surgical-gown-fda-510k.jpg K201351 - Maxima Surgical Gown K201351 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Elevate Textiles. Cleared Mar 2022. https://www.510kdatabase.net/k202075/ 2022-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k202075-dental-electric-motor-fda-510k.jpg K202075 - Dental Electric Motor K202075 is a FDA 510(k) cleared dental medical device. Manufacturer: Foshan Cicada Dental Instrument Co, Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k211880/ 2022-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k211880-minuteman-g5-mis-fusion-plate-fda-510k.jpg K211880 - Minuteman G5 MIS Fusion Plate K211880 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinal Simplicity, LLC. Cleared Mar 2022. https://www.510kdatabase.net/k211887/ 2022-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k211887-personal-kinetigraph-pkg-system-gen-2-fda-510k.jpg K211887 - Personal Kinetigraph (PKG) System Gen 2 Plus K211887 is a FDA 510(k) cleared neurology medical device. Manufacturer: Gkc Manufacturing Pty, Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k212040/ 2022-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k212040-rihip-modeler-fda-510k.jpg K212040 - RI.HIP MODELER K212040 is a FDA 510(k) cleared radiology medical device. Manufacturer: Blue Belt Technologies, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k212628/ 2022-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k212628-dess-dental-smart-solutions-fda-510k.jpg K212628 - DESS Dental Smart Solutions K212628 is a FDA 510(k) cleared dental medical device. Manufacturer: Terrats Medical SL. Cleared Mar 2022. https://www.510kdatabase.net/k212920/ 2022-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k212920-sterile-safety-syringe-with-needle-for-fda-510k.jpg K212920 - Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use,Sterile Auto-Disable Syringe with Needle for Single Use K212920 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shandong Weigao Group Medical Polymer Co., Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k213005/ 2022-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k213005-apollo-ankle-fracture-plating-system-fda-510k.jpg K213005 - Apollo Ankle Fracture Plating System K213005 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Glw Medical, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k213354/ 2022-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k213354-unify-multifunction-energy-platform-fda-510k.jpg K213354 - Unify Multifunction Energy Platform, CleanSeal Vessel Sealers, Unify Bipolar Resection Cables, Unify Wireless FootSwitch, Unify Cart K213354 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Conmed Corporation. Cleared Mar 2022. https://www.510kdatabase.net/k213534/ 2022-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k213534-phantom-trilogy-fda-510k.jpg K213534 - PHantom Trilogy K213534 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Resurgeonz, LLC. Cleared Mar 2022. https://www.510kdatabase.net/k213615/ 2022-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k213615-shoulder-innovations-total-shoulder-fda-510k.jpg K213615 - Shoulder Innovations Total Shoulder System K213615 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Shoulder Innovations, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k213658/ 2022-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k213658-deka-smartperio-fda-510k.jpg K213658 - DEKA SMARTPERIO K213658 is a FDA 510(k) cleared dental medical device. Manufacturer: El.En Electronic Engineering Spa. Cleared Mar 2022. https://www.510kdatabase.net/k213687/ 2022-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k213687-32ch-air-open-coil-suite-15t-air-open-fda-510k.jpg K213687 - 32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Open Neck Chest Anterior 7ch / 3.0T AIR Open Neck Chest Anterior 7ch, 1.5T AIR Open Head Anterior 16ch / 3.0T AIR Open Head Anterior 16ch K213687 is a FDA 510(k) cleared radiology medical device. Manufacturer: Neocoil, LLC. Cleared Mar 2022. https://www.510kdatabase.net/k213712/ 2022-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k213712-pectus-support-bar-system-fda-510k.jpg K213712 - Pectus Support Bar System K213712 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet Microfixation. Cleared Mar 2022. https://www.510kdatabase.net/k213725/ 2022-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k213725-cardiq-suite-fda-510k.jpg K213725 - CardIQ Suite K213725 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems SCS. Cleared Mar 2022. https://www.510kdatabase.net/k213827/ 2022-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k213827-titan-total-shoulder-system-tss-titan-fda-510k.jpg K213827 - TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), Katalyst Bipolar Radial Head System (Katalyst) K213827 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k213836/ 2022-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k213836-intracept-intraosseous-nerve-ablation-fda-510k.jpg K213836 - Intracept Intraosseous Nerve Ablation System K213836 is a FDA 510(k) cleared neurology medical device. Manufacturer: Relievant Medsystems, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k213869/ 2022-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k213869-embryoslide-ic8-dish-fda-510k.jpg K213869 - EmbryoSlide+ ic8 dish K213869 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Vitrolife A/S. Cleared Mar 2022. https://www.510kdatabase.net/k213957/ 2022-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k213957-demetra-dermatoscope-bdem-01-fda-510k.jpg K213957 - Demetra Dermatoscope BDEM-01 K213957 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Barco N.V.. Cleared Mar 2022. https://www.510kdatabase.net/k220315/ 2022-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k220315-montage-xt-settable-resorbable-fda-510k.jpg K220315 - MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty K220315 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthocon, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k220395/ 2022-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k220395-endogator-endoscopy-irrigation-tubing-fda-510k.jpg K220395 - EndoGator Endoscopy Irrigation Tubing K220395 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: STERIS Corporation. Cleared Mar 2022. https://www.510kdatabase.net/k220422/ 2022-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k220422-dental-sensors-nanopix1-nanopix2-fda-510k.jpg K220422 - Dental sensors NanoPix1, NanoPix2 K220422 is a FDA 510(k) cleared radiology medical device. Manufacturer: Iray Technology Taicang , Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k220425/ 2022-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k220425-magnetom-vida-magnetom-sola-fda-510k.jpg K220425 - MAGNETOM Vida, MAGNETOM Sola K220425 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k210341/ 2022-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k210341-one-step-pregnancy-test-fda-510k.jpg K210341 - One Step Pregnancy Test K210341 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Spd Swiss Precision Diagnostics GmbH. Cleared Mar 2022. https://www.510kdatabase.net/k210367/ 2022-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k210367-d-laser-blue-d-laser-16-fda-510k.jpg K210367 - D-Laser Blue, D-Laser 16 K210367 is a FDA 510(k) cleared dental medical device. Manufacturer: Guilin Woodpecker Medical Instrument Co., Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k211911/ 2022-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k211911-kolibri-percutaneous-nephrostomy-fda-510k.jpg K211911 - Kolibri Percutaneous Nephrostomy Catheters, Kolibri Percutaneous Nephrostomy Kits, Kolibri Direct Puncture Sets K211911 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Coloplast Corp.. Cleared Mar 2022. https://www.510kdatabase.net/k212148/ 2022-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k212148-non-sterile-powder-free-fda-510k.jpg K212148 - Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use with Chemotherapy Drugs K212148 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ansell Healthcare Products, LLC. Cleared Mar 2022. https://www.510kdatabase.net/k212165/ 2022-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k212165-reprocessed-carto-vizigo-bi-fda-510k.jpg K212165 - Reprocessed Carto Vizigo Bi-Directional Guiding Sheath K212165 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Innovative Health, LLC. Cleared Mar 2022. https://www.510kdatabase.net/k212755/ 2022-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k212755-signus-sacronail-transsacral-fda-510k.jpg K212755 - SIGNUS SACRONAIL® Transsacral Stabilization System K212755 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Signus Medizintechnik GmbH. Cleared Mar 2022. https://www.510kdatabase.net/k212965/ 2022-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k212965-smile-100-system-fda-510k.jpg K212965 - Smile-100 System K212965 is a FDA 510(k) cleared radiology medical device. Manufacturer: Niramai Health Analytix Private Limited. Cleared Mar 2022. https://www.510kdatabase.net/k213038/ 2022-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k213038-infrared-forehead-thermometer-model-hs-fda-510k.jpg K213038 - Infrared Forehead Thermometer, model: HS-9802D K213038 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiaxing Shangjia Intelligence Technology Co., Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k213373/ 2022-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k213373-powder-free-green-biodegradable-fda-510k.jpg K213373 - Powder-Free Green Biodegradable Nitrile Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate K213373 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Smart Glove Corporation Sdn. Bhd.. Cleared Mar 2022. https://www.510kdatabase.net/k213486/ 2022-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k213486-glp-systems-track-fda-510k.jpg K213486 - GLP systems Track K213486 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Mar 2022. https://www.510kdatabase.net/k213566/ 2022-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k213566-clearread-xray-pneumothorax-fda-510k.jpg K213566 - ClearRead Xray Pneumothorax K213566 is a FDA 510(k) cleared radiology medical device. Manufacturer: Riverain Technologies, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k213751/ 2022-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k213751-nextar-tka-platform-my-knee-pps-fda-510k.jpg K213751 - NextAR™ TKA Platform My Knee PPS K213751 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Mar 2022. https://www.510kdatabase.net/k213910/ 2022-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k213910-disposable-medical-nitrile-examination-fda-510k.jpg K213910 - Disposable Medical Nitrile Examination Gloves- Tested for Use with Chemotherapy Drugs K213910 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Changzhou Universal Medical Equipment Co., Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k214071/ 2022-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k214071-hexa-temp-fda-510k.jpg K214071 - Hexa-Temp K214071 is a FDA 510(k) cleared dental medical device. Manufacturer: Spident Co., Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k220133/ 2022-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k220133-sterilization-wraps-fda-510k.jpg K220133 - Sterilization Wraps K220133 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Weihai Hongyu Nonwoven Fabric Products Co., Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k220361/ 2022-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k220361-reliance-eps-endoscope-processing-fda-510k.jpg K220361 - Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide K220361 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Mar 2022. https://www.510kdatabase.net/k211155/ 2022-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k211155-auto-cpap-system-fda-510k.jpg K211155 - Auto CPAP System K211155 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: BMC Medical Co., Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k211780/ 2022-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k211780-zen-2090-turbo-fda-510k.jpg K211780 - ZEN-2090 Turbo K211780 is a FDA 510(k) cleared radiology medical device. Manufacturer: Genoray Co., Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k212499/ 2022-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k212499-bd-insulin-syringe-03ml-fda-510k.jpg K212499 - BD Insulin Syringe (0.3mL) K212499 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson and Company. Cleared Mar 2022. https://www.510kdatabase.net/k213441/ 2022-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k213441-pathloc-lumbar-interbody-fusion-cage-fda-510k.jpg K213441 - PathLoc Lumbar Interbody Fusion Cage System K213441 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: L & K Biomed Co., Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k213849/ 2022-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k213849-safeop-2-neural-informatix-system-fda-510k.jpg K213849 - SafeOp 2: Neural Informatix System K213849 is a FDA 510(k) cleared neurology medical device. Manufacturer: Alphatec Spine, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k213851/ 2022-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k213851-disposable-medical-nitrile-gloves-fda-510k.jpg K213851 - Disposable Medical Nitrile gloves K213851 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guangdong Xingcan Brothers Medical Technology Co.,Ltd. Cleared Mar 2022. https://www.510kdatabase.net/k220069/ 2022-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k220069-4k-uhd-lcd-monitor-oev321uh-fda-510k.jpg K220069 - 4K UHD LCD Monitor OEV321UH K220069 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Mar 2022. https://www.510kdatabase.net/k220096/ 2022-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k220096-genesys-spine-3dp-lumbar-interbody-fda-510k.jpg K220096 - Genesys Spine 3DP Lumbar Interbody System K220096 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Genesys Spine. Cleared Mar 2022. https://www.510kdatabase.net/k220340/ 2022-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k220340-amplatzer-steerable-delivery-sheath-fda-510k.jpg K220340 - Amplatzer Steerable Delivery Sheath K220340 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared Mar 2022. https://www.510kdatabase.net/k220376/ 2022-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k220376-acetabular-dome-hole-plug-fda-510k.jpg K220376 - Acetabular Dome Hole Plug K220376 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp., Dba Stryker Orthopaedics. Cleared Mar 2022. https://www.510kdatabase.net/k203637/ 2022-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k203637-speedicath-compact-28578-28580-28582-fda-510k.jpg K203637 - SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814) K203637 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Coloplast. Cleared Mar 2022. https://www.510kdatabase.net/k211138/ 2022-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k211138-reprocessed-pulse-oximeter-sensor-d-25-fda-510k.jpg K211138 - Reprocessed Pulse Oximeter Sensor (D-25), Reprocessed Pulse Oximeter Sensor (D-25L), Reprocessed Pulse Oximeter Sensor (D-20), Reprocessed Pulse Oximeter Sensor (N-25), Reprocessed Pulse Oximeter Sensor (I-20), Reprocessed Pulse Oximeter Sensor (Max-A), Reprocessed Pulse Oximeter Sensor (Max-AL), Reprocessed Pulse Oximeter Sensor (Max-P), Reprocessed Pulse Oximeter Sensor (Max-N), Reprocessed Pulse Oximeter Sensor (Max-I) K211138 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Stryker Sustainability Solutions. Cleared Mar 2022. https://www.510kdatabase.net/k211140/ 2022-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k211140-reprocessed-masimo-pulse-oximeter-1859-fda-510k.jpg K211140 - Reprocessed Masimo Pulse Oximeter (1859 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (1860 Pediatric O2 Transducer), Reprocessed Masimo Pulse Oximeter (1861 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (1862 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2317 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2319 Infant O2 Transducer), Reprocessed Masimo Pulse Oximeter (2320 Adult O2 Transducer), Reprocessed Masimo Pulse Oximeter (2328 Infant O2 K211140 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Stryker Sustainability Solutions. Cleared Mar 2022. https://www.510kdatabase.net/k212049/ 2022-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k212049-oclet-tds-1000-fda-510k.jpg K212049 - Oclet TDS 1000 K212049 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Tendonova Corporation. Cleared Mar 2022. https://www.510kdatabase.net/k213434/ 2022-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k213434-elation-pulmonary-balloon-dilation-fda-510k.jpg K213434 - Elation Pulmonary Balloon Dilation Catheter K213434 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k213558/ 2022-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k213558-ipl-hair-removal-device-fda-510k.jpg K213558 - IPL Hair Removal Device K213558 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ulike Co., Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k213741/ 2022-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k213741-tens-ems-device-model-fm-b2403a-fda-510k.jpg K213741 - TENS & EMS DEVICE (Model: FM-B2403A) K213741 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Shenzhen Jian Feng Electronic Technology Co., Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k214087/ 2022-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k214087-medical-face-mask-fda-510k.jpg K214087 - Medical Face Mask K214087 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hubei Medlink Healthcare Co., Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k220374/ 2022-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k220374-expedium-verse-fenestrated-screw-fda-510k.jpg K220374 - EXPEDIUM VERSE® Fenestrated Screw System (Sterile Fenestrated Screws) K220374 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International SARL. Cleared Mar 2022. https://www.510kdatabase.net/k211639/ 2022-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k211639-btl-785w-fda-510k.jpg K211639 - BTL-785W K211639 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: BTL Industries, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k220450/ 2022-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k220450-syngoct-applications-fda-510k.jpg K220450 - syngo.CT Applications K220450 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k220506/ 2022-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k220506-skinpen-precision-system-fda-510k.jpg K220506 - SkinPen Precision System K220506 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Crown Aesthetics. Cleared Mar 2022. https://www.510kdatabase.net/k202675/ 2022-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k202675-inroad-dental-synthetic-bone-graft-fda-510k.jpg K202675 - InRoad® Dental Synthetic Bone Graft K202675 is a FDA 510(k) cleared dental medical device. Manufacturer: Osteogene Tech Corp. Cleared Mar 2022. https://www.510kdatabase.net/k210216/ 2022-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k210216-disposable-automatically-retractable-fda-510k.jpg K210216 - Disposable Automatically Retractable Insulin Safety Syringe K210216 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shantou Wealy Medical Instrument Co.,Ltd. Cleared Mar 2022. https://www.510kdatabase.net/k210330/ 2022-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k210330-powder-free-black-nitrile-examination-fda-510k.jpg K210330 - Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant K210330 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wrp Asia Pacific Sdn. Bhd.. Cleared Mar 2022. https://www.510kdatabase.net/k210365/ 2022-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k210365-second-opinion-fda-510k.jpg K210365 - Second Opinion K210365 is a FDA 510(k) cleared radiology medical device. Manufacturer: Pearl, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k211808/ 2022-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k211808-medcare-powder-free-blue-nitrile-fda-510k.jpg K211808 - Medcare Powder-Free Blue Nitrile Patient Examination Gloves K211808 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Dongguan Grinvald Technology Co., Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k211843/ 2022-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k211843-polylock-plating-system-fda-510k.jpg K211843 - PolyLock Plating System K211843 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Fusion Orthopedics. Cleared Mar 2022. https://www.510kdatabase.net/k211900/ 2022-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k211900-patient-information-center-ix-fda-510k.jpg K211900 - Patient Information Center iX K211900 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Philips Medizin Systeme B?blingen GmbH. Cleared Mar 2022. https://www.510kdatabase.net/k211919/ 2022-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k211919-kiss-dynamic-back-support-kiss-dynamic-fda-510k.jpg K211919 - KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat K211919 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Kinetic Innovative Seating System, LLC. Cleared Mar 2022. https://www.510kdatabase.net/k212281/ 2022-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k212281-surgical-trays-fda-510k.jpg K212281 - Surgical Trays K212281 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Dentsply Sirona, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k212356/ 2022-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k212356-exactech-equinoxe-laser-cage-glenoid-fda-510k.jpg K212356 - Exactech® Equinoxe® Laser Cage Glenoid K212356 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k212723/ 2022-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k212723-btl-995-rtms-fda-510k.jpg K212723 - BTL-995-rTMS K212723 is a FDA 510(k) cleared neurology medical device. Manufacturer: BTL Industries, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k212940/ 2022-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k212940-skanmobile-skanmobile-dr-fda-510k.jpg K212940 - Skanmobile, Skanmobile-Dr K212940 is a FDA 510(k) cleared radiology medical device. Manufacturer: Skanray Technologies Limited. Cleared Mar 2022. https://www.510kdatabase.net/k213358/ 2022-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k213358-surgical-mask-fda-510k.jpg K213358 - Surgical Mask K213358 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k213703/ 2022-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k213703-surgical-gown-fda-510k.jpg K213703 - Surgical Gown K213703 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wujiang Tutaike Textiles & Finishing Co., Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k213994/ 2022-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k213994-flexible-block-fda-510k.jpg K213994 - Flexible Block K213994 is a FDA 510(k) cleared dental medical device. Manufacturer: Shandong Huge Dental Material Corporation. Cleared Mar 2022. https://www.510kdatabase.net/k220051/ 2022-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k220051-te-air-diagnostic-ultrasound-system-fda-510k.jpg K220051 - TE Air Diagnostic Ultrasound System K220051 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k220327/ 2022-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k220327-geko-w-3-fda-510k.jpg K220327 - geko W-3 K220327 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Firstkind Limited. Cleared Mar 2022. https://www.510kdatabase.net/k211658/ 2022-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k211658-or-head-holder-lucy-with-headcoilset-fda-510k.jpg K211658 - OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with HeadCoilSet Siemens 3T, OR Head Holder LUCY with HeadCoilSet Philips 1.5T, OR Head Holder LUCY with HeadCoilSet Philips 3T K211658 is a FDA 510(k) cleared radiology medical device. Manufacturer: Noras Mri Products GmbH. Cleared Mar 2022. https://www.510kdatabase.net/k211787/ 2022-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k211787-hemoclip-fda-510k.jpg K211787 - Hemoclip K211787 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hangzhou AGS MedTech Co., Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k211811/ 2022-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k211811-disposable-endoscopic-staplers-and-fda-510k.jpg K211811 - Disposable Endoscopic Staplers and Reload Unit, Disposable Hemorrhoidal Cutter Staplers, Disposable Linear Cutter Staplers, Disposable Circular Staplers K211811 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wuxi Beien Surgery Device Co., Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k211850/ 2022-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k211850-air-compression-leg-massager-model-fe-fda-510k.jpg K211850 - Air Compression Leg Massager (model: FE-7204B) K211850 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Xiamen Healthpal Electronic Co.,Ltd. Cleared Mar 2022. https://www.510kdatabase.net/k212149/ 2022-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k212149-myndmove-20-fda-510k.jpg K212149 - MyndMove 2.0 K212149 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Myndtec, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k212676/ 2022-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k212676-osteon-precision-milled-suprastructure-fda-510k.jpg K212676 - Osteon Precision Milled Suprastructure K212676 is a FDA 510(k) cleared dental medical device. Manufacturer: Implant Solutions Pty Ltd (Osteon Medical). Cleared Mar 2022. https://www.510kdatabase.net/k212720/ 2022-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k212720-nordicdsc-fda-510k.jpg K212720 - nordicDSC K212720 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nordicneurolab AS. Cleared Mar 2022. https://www.510kdatabase.net/k213285/ 2022-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k213285-easy-claire-fda-510k.jpg K213285 - easy Claire K213285 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Y & J Bio Co., Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k213516/ 2022-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k213516-ingenia-30t-ingenia-30t-cx-ingenia-fda-510k.jpg K213516 - Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nudclei K213516 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Mar 2022. https://www.510kdatabase.net/k213671/ 2022-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k213671-astroglide-sensual-strawberry-personal-fda-510k.jpg K213671 - Astroglide Sensual Strawberry Personal Lubricant K213671 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Biofilm, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k213778/ 2022-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k213778-iv-administration-set-fda-510k.jpg K213778 - IV Administration Set K213778 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k213835/ 2022-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k213835-tens-ems-device-fda-510k.jpg K213835 - TENS & EMS Device K213835 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Shenzhen Jian Feng Electronic Technology Co., Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k220018/ 2022-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k220018-mr-elastography-fda-510k.jpg K220018 - MR Elastography K220018 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Mar 2022. https://www.510kdatabase.net/k220379/ 2022-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k220379-impeace-and-impeace-uni-anterior-fda-510k.jpg K220379 - IMPEACE and IMPEACE-Uni Anterior Cervical Plate System K220379 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medynus, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k201861/ 2022-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k201861-bio-fluff-system-fda-510k.jpg K201861 - Bio Fluff System K201861 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Gnali Bocia S.R.L.. Cleared Mar 2022. https://www.510kdatabase.net/k203376/ 2022-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k203376-astm-level-1en14683-type-iir-3-ply-fda-510k.jpg K203376 - ASTM Level 1/EN14683 Type IIR 3-Ply disposable Surgical Mask, Model number: FM-1400G K203376 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medtecs (Taiwan) Corp.. Cleared Mar 2022. https://www.510kdatabase.net/k210923/ 2022-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k210923-southern-implants-instrument-trays-fda-510k.jpg K210923 - Southern Implants Instrument Trays K210923 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Southern Implants (Pty), Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k211183/ 2022-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k211183-sugita-avm-microclips-fda-510k.jpg K211183 - Sugita AVM Microclips K211183 is a FDA 510(k) cleared neurology medical device. Manufacturer: Mizuho America, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k212379/ 2022-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k212379-n-latex-flc-kappa-n-latex-flc-lambda-fda-510k.jpg K212379 - N Latex FLC kappa, N Latex FLC lambda K212379 is a FDA 510(k) cleared immunology medical device. Manufacturer: Siemens Healthcare Diagnostics Products GmbH. Cleared Mar 2022. https://www.510kdatabase.net/k212652/ 2022-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k212652-sterile-syringe-with-fixed-safety-fda-510k.jpg K212652 - Sterile Syringe with Fixed Safety Needle for Single Use K212652 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Gemtier Medical (Shanghai), Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k212698/ 2022-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k212698-plus-medical-isolation-gown-level-3-fda-510k.jpg K212698 - Plus Medical Isolation Gown Level 3 K212698 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Foshan Nanhai Plus Medical Co, Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k213127/ 2022-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k213127-renew-disposable-scissor-tips-fda-510k.jpg K213127 - ReNew Disposable Scissor Tips K213127 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Microline Surgical, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k213135/ 2022-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k213135-plasma-edge-resection-and-vaporization-fda-510k.jpg K213135 - Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge K213135 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Chirurgie Innovation. Cleared Mar 2022. https://www.510kdatabase.net/k213279/ 2022-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k213279-novaguide-2-intelligent-ultrasound-fda-510k.jpg K213279 - NovaGuide 2 Intelligent Ultrasound K213279 is a FDA 510(k) cleared radiology medical device. Manufacturer: Novasignal Corporation. Cleared Mar 2022. https://www.510kdatabase.net/k213457/ 2022-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k213457-fort-defiance-industries-front-line-fda-510k.jpg K213457 - Fort Defiance Industries FRONT-LINE Field Sterilizer FL120, Fort Defiance Industries FRONT-LINE Field Sterilizer FL135 K213457 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Fort Defiance Industries, LLC. Cleared Mar 2022. https://www.510kdatabase.net/k213551/ 2022-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k213551-giraffe-omnibed-carestation-cs1-fda-510k.jpg K213551 - Giraffe Omnibed Carestation CS1 K213551 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Datex-Ohmeda, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k213553/ 2022-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k213553-giraffe-incubator-carestation-cs1-fda-510k.jpg K213553 - Giraffe Incubator Carestation CS1 K213553 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Datex-Ohmeda, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k213567/ 2022-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k213567-medline-unite-calcaneal-fracture-fda-510k.jpg K213567 - Medline UNITE Calcaneal Fracture Plating System K213567 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medline Industries, LP. Cleared Mar 2022. https://www.510kdatabase.net/k213579/ 2022-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k213579-stellaris-2d-stellaris-2d-ceph-fda-510k.jpg K213579 - Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph K213579 is a FDA 510(k) cleared radiology medical device. Manufacturer: Fona S.R.L. Cleared Mar 2022. https://www.510kdatabase.net/k213932/ 2022-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k213932-a-dec-300-a-dec-500-fda-510k.jpg K213932 - A-dec 300, A-dec 500 K213932 is a FDA 510(k) cleared dental medical device. Manufacturer: A-Dec, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k214091/ 2022-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k214091-dental-image-plate-scanner-model-dfc-fda-510k.jpg K214091 - Dental Image Plate Scanner, Model DFC-4T-SMART K214091 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hefei Dentafilm Medical Equipment Co., Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k220006/ 2022-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k220006-angiolock-polymer-ligating-clip-fda-510k.jpg K220006 - angioLOCK Polymer Ligating Clip K220006 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: A2 Medical Systems, LLC. Cleared Mar 2022. https://www.510kdatabase.net/k202046/ 2022-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k202046-lota-sla-dental-implant-system-and-fda-510k.jpg K202046 - LOTA SLA Dental Implant System and LOTA HA Dental Implant System K202046 is a FDA 510(k) cleared dental medical device. Manufacturer: Kj Meditech Co., Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k210073/ 2022-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k210073-agilia-vp-infusion-system-agilia-vp-mc-fda-510k.jpg K210073 - Agilia VP Infusion System, Agilia VP MC WIFI Infusion Pump, Volumat Lines Administration Sets, Agilia Link, Agilia Duo K210073 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Fresenius Kabi AG. Cleared Mar 2022. https://www.510kdatabase.net/k210074/ 2022-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k210074-agilia-sp-infusion-system-agilia-sp-mc-fda-510k.jpg K210074 - Agilia SP Infusion System, Agilia SP MC WIFI Infusion Pump, Agilia Link, Agilia Duo, Agilia USB Cable K210074 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Fresenius Kabi AG. Cleared Mar 2022. https://www.510kdatabase.net/k210075/ 2022-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k210075-vigilant-software-suite-vigilant-fda-510k.jpg K210075 - Vigilant Software Suite – Vigilant Master Med K210075 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Fresenius Kabi AG. Cleared Mar 2022. https://www.510kdatabase.net/k210151/ 2022-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k210151-digimamo-d-fda-510k.jpg K210151 - Digimamo D K210151 is a FDA 510(k) cleared radiology medical device. Manufacturer: Vmi Tecnologias Ltda. Cleared Mar 2022. https://www.510kdatabase.net/k210811/ 2022-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k210811-dynamyx-digital-pathology-software-fda-510k.jpg K210811 - Dynamyx Digital Pathology Software K210811 is a FDA 510(k) cleared pathology medical device. Manufacturer: Inspirata, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k210848/ 2022-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k210848-sure-fine-insulin-syringes-fda-510k.jpg K210848 - Sure-Fine Insulin Syringes K210848 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shina Med Corporation. Cleared Mar 2022. https://www.510kdatabase.net/k211484/ 2022-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k211484-disposablesterilesyringewithsafetyneedle-fda-510k.jpg K211484 - Disposable Sterile Syringe with Safety Needle K211484 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shinva Ande Healthcare Apparatus Co., Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k211776/ 2022-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k211776-microlife-non-contact-infrared-fda-510k.jpg K211776 - Microlife Non-Contact Infrared Forehead Thermometer, Model FR1MF1-B (NC150 BT) K211776 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Microlife Intellectual Property GmbH. Cleared Mar 2022. https://www.510kdatabase.net/k211802/ 2022-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k211802-goback-crossing-catheter-fda-510k.jpg K211802 - GoBack Crossing Catheter K211802 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Upstream Peripheral Technologies, Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k211868/ 2022-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k211868-myah-fda-510k.jpg K211868 - MYAH K211868 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Visia Imaging S.R.L.. Cleared Mar 2022. https://www.510kdatabase.net/k212057/ 2022-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k212057-endoluminal-occlusion-system-eos-x-fda-510k.jpg K212057 - Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS K212057 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Artventive Medical Group, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k212187/ 2022-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k212187-restoration-modular-hip-system-fda-510k.jpg K212187 - Restoration® Modular Hip System K212187 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp., Dba Stryker Orthopaedics. Cleared Mar 2022. https://www.510kdatabase.net/k212365/ 2022-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k212365-boneview-fda-510k.jpg K212365 - BoneView K212365 is a FDA 510(k) cleared radiology medical device. Manufacturer: Gleamer. Cleared Mar 2022. https://www.510kdatabase.net/k212596/ 2022-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k212596-sterile-latex-surgical-gloves-powder-fda-510k.jpg K212596 - Sterile Latex Surgical Gloves Powder Free K212596 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Amazing Rubber Products Pvt, Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k212945/ 2022-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k212945-sterile-disposable-temperature-probe-fda-510k.jpg K212945 - Sterile Disposable Temperature Probe K212945 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen Envisen Industry Co., Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k213189/ 2022-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k213189-wrist-type-fully-automatic-digital-fda-510k.jpg K213189 - Wrist-type Fully Automatic Digital Blood Pressure Monitor K213189 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Joytech Healthcare Co. , Ltd.. Cleared Mar 2022. https://www.510kdatabase.net/k213400/ 2022-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k213400-grosz-play-aloe-grosz-play-ylang-grosz-fda-510k.jpg K213400 - Grosz Play Aloe, Grosz Play Ylang, Grosz Play Guarana, Grosz Play Cherry, Grosz Play Strawberry K213400 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Rb Health (Us). Cleared Mar 2022. https://www.510kdatabase.net/k213590/ 2022-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k213590-blue-topaz-sacroiliac-screw-system-fda-510k.jpg K213590 - Blue Topaz Sacroiliac Screw System K213590 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osseus Fusion Systems, LLC. Cleared Mar 2022. https://www.510kdatabase.net/k220109/ 2022-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k220109-diamondback-360-peripheral-orbital-fda-510k.jpg K220109 - DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System K220109 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cardiovascular Systems, Inc.. Cleared Mar 2022. https://www.510kdatabase.net/k211661/ 2022-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k211661-enfit-enteral-syringes-nutrifit-fda-510k.jpg K211661 - ENFit enteral syringes (NUTRIFIT) K211661 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Pentaferte Italia S.R.L.. Cleared Feb 2022. https://www.510kdatabase.net/k212833/ 2022-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k212833-disposable-nitrile-examination-gloves-fda-510k.jpg K212833 - Disposable Nitrile Examination Gloves K212833 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Chifeng Huawei Medical Science&Technology Co., Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k213635/ 2022-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k213635-vathin-video-bronchoscope-system-fda-510k.jpg K213635 - Vathin Video Bronchoscope System K213635 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Hunan Vathin Medical Instrument Co., Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k213750/ 2022-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k213750-vylink-spinal-screw-system-fda-510k.jpg K213750 - VyLink™ Spinal Screw System K213750 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Vy Spine, LLC. Cleared Feb 2022. https://www.510kdatabase.net/k193406/ 2022-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k193406-cardiochek-plus-test-system-fda-510k.jpg K193406 - CardioChek Plus Test System K193406 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Polymer Technology Systems, Inc. D/B/A Pts Diagnostics. Cleared Feb 2022. https://www.510kdatabase.net/k203113/ 2022-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k203113-masimo-sedline-sedation-monitor-and-fda-510k.jpg K203113 - Masimo SedLine Sedation Monitor and Accessories K203113 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Masimo Corporation. Cleared Feb 2022. https://www.510kdatabase.net/k203150/ 2022-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k203150-cool-tip-rf-ablation-system-e-series-fda-510k.jpg K203150 - Cool-tip RF Ablation System E Series K203150 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien, LLC. Cleared Feb 2022. https://www.510kdatabase.net/k203541/ 2022-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k203541-okamoto-002-lubricated-polyurethane-fda-510k.jpg K203541 - Okamoto 002 Lubricated Polyurethane Male Condom K203541 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Okamoto USA, Inc.. Cleared Feb 2022. https://www.510kdatabase.net/k211711/ 2022-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k211711-omnitom-elite-fda-510k.jpg K211711 - OmniTom Elite K211711 is a FDA 510(k) cleared radiology medical device. Manufacturer: Neurologica Corporation, A Subsidiary of Samsung Electronics. Cleared Feb 2022. https://www.510kdatabase.net/k211722/ 2022-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k211722-laser-treatment-system-models-nyx-plus-fda-510k.jpg K211722 - Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares K211722 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Canadian Pioneer Medical Technology Corporation. Cleared Feb 2022. https://www.510kdatabase.net/k211855/ 2022-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k211855-ion-facet-screw-system-fda-510k.jpg K211855 - Ion Facet Screw System K211855 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SurGenTec, LLC. Cleared Feb 2022. https://www.510kdatabase.net/k212300/ 2022-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k212300-pulse-oximeter-fda-510k.jpg K212300 - Pulse Oximeter K212300 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Mericonn Technology Co., Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k212800/ 2022-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k212800-prima-humeral-system-and-smr-fda-510k.jpg K212800 - PRIMA Humeral System and SMR Glenosphere Ø42 K212800 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Lima Corporate S.P.A.. Cleared Feb 2022. https://www.510kdatabase.net/k213043/ 2022-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k213043-levator-elite-model-le9011-fda-510k.jpg K213043 - Levator Elite (Model LE9011) K213043 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Shenzhen Dongdixin Technology Co., Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k213084/ 2022-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k213084-ear-thermometer-model-et005-et008-et009-fda-510k.jpg K213084 - Ear Thermometer, Model ET005, ET008, ET009 K213084 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guangzhou Berrcom Medical Device Co., Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k213241/ 2022-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k213241-vitek-2-ast-yeast-fluconazole-05-64-fda-510k.jpg K213241 - VITEK 2 AST-Yeast Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole (<=0.5->=64 µg/mL), VITEK 2 AST-YS Fluconazole K213241 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Feb 2022. https://www.510kdatabase.net/k213693/ 2022-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k213693-magnetom-vida-with-syngo-mr-xa50a-fda-510k.jpg K213693 - MAGNETOM Vida with syngo MR XA50A K213693 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 2022. https://www.510kdatabase.net/k214066/ 2022-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k214066-feops-heartguide-fda-510k.jpg K214066 - FEops HEARTguide K214066 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Feops NV. Cleared Feb 2022. https://www.510kdatabase.net/k214097/ 2022-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k214097-explorer-air-ii-fda-510k.jpg K214097 - Explorer Air II K214097 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Surgvision GmbH. Cleared Feb 2022. https://www.510kdatabase.net/k220217/ 2022-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k220217-normatec-3-fda-510k.jpg K220217 - Normatec 3 K220217 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: NormaTec Industries, LP. Cleared Feb 2022. https://www.510kdatabase.net/k220238/ 2022-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k220238-cohitech-cottonlock-tampons-with-fda-510k.jpg K220238 - Cohitech Cottonlock Tampons with Reusable Applicator K220238 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Cotton High Tech S.L.. Cleared Feb 2022. https://www.510kdatabase.net/k202845/ 2022-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k202845-bodygard-sfs-surgical-gown-level-3-fda-510k.jpg K202845 - Bodygard SFS Surgical Gown Level 3 K202845 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi. Cleared Feb 2022. https://www.510kdatabase.net/k210135/ 2022-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k210135-promogran-prisma-matrix-small-dressing-fda-510k.jpg K210135 - PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing K210135 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3M Healthcare Business Group. Cleared Feb 2022. https://www.510kdatabase.net/k211320/ 2022-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k211320-capri-corpectomy-cage-system-fda-510k.jpg K211320 - CAPRI Corpectomy Cage System K211320 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: K2m, Inc.. Cleared Feb 2022. https://www.510kdatabase.net/k211510/ 2022-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k211510-ulab-systems-dental-aligner-kit-fda-510k.jpg K211510 - uLab Systems Dental Aligner Kit K211510 is a FDA 510(k) cleared dental medical device. Manufacturer: Ulab Systems, Inc.. Cleared Feb 2022. https://www.510kdatabase.net/k211645/ 2022-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k211645-epione-fda-510k.jpg K211645 - Epione K211645 is a FDA 510(k) cleared radiology medical device. Manufacturer: Quantum Surgical Sas. Cleared Feb 2022. https://www.510kdatabase.net/k211798/ 2022-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k211798-cleaner-plus-thrombectomy-system-fda-510k.jpg K211798 - Cleaner Plus Thrombectomy System K211798 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Argon Medical Devices, Inc.. Cleared Feb 2022. https://www.510kdatabase.net/k212949/ 2022-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k212949-sterile-syringe-with-safety-needle-for-fda-510k.jpg K212949 - Sterile Syringe with Safety Needle for Single Use, Sterile Syringe with Needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use, Sterile Needle for Single Use K212949 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Henan Nursecare Biotechnology Co., Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k213941/ 2022-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k213941-annalise-enterprise-cxr-triage-fda-510k.jpg K213941 - Annalise Enterprise CXR Triage Pneumothorax K213941 is a FDA 510(k) cleared radiology medical device. Manufacturer: Annalise-Ai. Cleared Feb 2022. https://www.510kdatabase.net/k214094/ 2022-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k214094-roki-surgical-mask-fda-510k.jpg K214094 - ROKI Surgical Mask K214094 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Roki Co., Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k214100/ 2022-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k214100-luminice-fda-510k.jpg K214100 - Luminice K214100 is a FDA 510(k) cleared neurology medical device. Manufacturer: Premier North America, Inc.. Cleared Feb 2022. https://www.510kdatabase.net/k220028/ 2022-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k220028-nightowl-fda-510k.jpg K220028 - NightOwl K220028 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Ectosense NV. Cleared Feb 2022. https://www.510kdatabase.net/k220384/ 2022-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k220384-artisential-laparoscopic-instruments-fda-510k.jpg K220384 - ArtiSential Laparoscopic Instruments-Electrodes K220384 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Livsmed, Inc.. Cleared Feb 2022. https://www.510kdatabase.net/k211965/ 2022-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k211965-stimrouter-neuromodulation-system-fda-510k.jpg K211965 - StimRouter Neuromodulation System K211965 is a FDA 510(k) cleared neurology medical device. Manufacturer: Bioness, Inc.. Cleared Feb 2022. https://www.510kdatabase.net/k212378/ 2022-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k212378-arsenal-ankle-plating-system-fda-510k.jpg K212378 - Arsenal Ankle Plating System K212378 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Trilliant Surgical. Cleared Feb 2022. https://www.510kdatabase.net/k212668/ 2022-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k212668-sclerotherapy-needle-fda-510k.jpg K212668 - Sclerotherapy Needle K212668 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Zhejiang Chuangxiang Medical Technology Co., Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k212786/ 2022-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k212786-levalap-laparoscopic-access-device-fda-510k.jpg K212786 - LevaLap Laparoscopic Access Device K212786 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Core Access Surgical Technologies, Inc.. Cleared Feb 2022. https://www.510kdatabase.net/k213599/ 2022-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k213599-superline-fda-510k.jpg K213599 - SuperLine K213599 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentium Co., Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k213654/ 2022-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k213654-nuvasive-reline-cervical-system-fda-510k.jpg K213654 - NuVasive Reline Cervical System K213654 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Feb 2022. https://www.510kdatabase.net/k214102/ 2022-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k214102-glidewell-appliance-resin-hardsoft-fda-510k.jpg K214102 - Glidewell Appliance Resin, Hard/Soft K214102 is a FDA 510(k) cleared dental medical device. Manufacturer: Prismatik Dentalcraft, Inc.. Cleared Feb 2022. https://www.510kdatabase.net/k220003/ 2022-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k220003-ezortho-v13-fda-510k.jpg K220003 - EzOrtho v1.3 K220003 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ewoosoft Co., Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k220197/ 2022-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k220197-trigon-ha-wedge-fixation-system-fda-510k.jpg K220197 - Trigon HA Wedge Fixation System K220197 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nvision Biomedical Technologies, Inc.. Cleared Feb 2022. https://www.510kdatabase.net/den210034/ 2022-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/den210034-one-male-condom-fda-510k.jpg DEN210034 - ONE Male Condom DEN210034 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Global Protection Corp.. Cleared Feb 2022. https://www.510kdatabase.net/k211686/ 2022-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k211686-flexible-video-choledo-cysto-fda-510k.jpg K211686 - Flexible Video-Choledo-Cysto-Ureteroscope System K211686 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Shanghai SeeGen Photoelectric Technology Co., Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k212380/ 2022-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k212380-pds-plus-antibacterial-polydioxanone-fda-510k.jpg K212380 - PDS Plus Antibacterial (Polydioxanone) Sterile Synthetic Absorable Surgical Suture K212380 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Feb 2022. https://www.510kdatabase.net/k213392/ 2022-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k213392-inliant-surgical-navigation-system-fda-510k.jpg K213392 - INLIANT Surgical Navigation System K213392 is a FDA 510(k) cleared dental medical device. Manufacturer: Navigate Surgical Technologies, Inc.. Cleared Feb 2022. https://www.510kdatabase.net/k213991/ 2022-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k213991-enbio-s-fda-510k.jpg K213991 - Enbio S K213991 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Enbio Group AG. Cleared Feb 2022. https://www.510kdatabase.net/k220471/ 2022-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k220471-valo-x-valo-x-accessory-lenses-fda-510k.jpg K220471 - VALO X, VALO X Accessory Lenses K220471 is a FDA 510(k) cleared dental medical device. Manufacturer: Ultradent Products, Inc.. Cleared Feb 2022. https://www.510kdatabase.net/k203548/ 2022-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k203548-endoarmor-surgical-gown-fda-510k.jpg K203548 - EndoArmor™ + Surgical Gown K203548 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Boston Scientific Corporation. Cleared Feb 2022. https://www.510kdatabase.net/k213500/ 2022-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k213500-tmg-nitrile-powder-free-examination-fda-510k.jpg K213500 - TMG Nitrile Powder Free Examination Glove K213500 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Thai Medical Glove Co., Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k213548/ 2022-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k213548-nitrylex-classic-powder-free-nitrile-fda-510k.jpg K213548 - Nitrylex Classic Powder Free Nitrile Blue Examination Gloves Tested for Use with Chemotherapy K213548 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Mercator Medical (Thailand), Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k213724/ 2022-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k213724-medical-surgical-mask-fda-510k.jpg K213724 - Medical Surgical Mask K213724 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hunan Zhenheyikang Medical Instrument Co., Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k220232/ 2022-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k220232-nitrile-powder-free-examination-gloves-fda-510k.jpg K220232 - Nitrile Powder Free Examination Gloves, Non-Sterile - Blue, Black, Orange K220232 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Megine Industries Sdn Bhd. Cleared Feb 2022. https://www.510kdatabase.net/k212366/ 2022-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k212366-heartland-health-surgical-mask-fda-510k.jpg K212366 - Heartland Health Surgical Mask K212366 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Heartland Health Products. Cleared Feb 2022. https://www.510kdatabase.net/k212863/ 2022-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k212863-surgical-face-mask-fda-510k.jpg K212863 - Surgical Face Mask K212863 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Taiwan Comfort Champ Manufacturing Co., Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k212935/ 2022-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k212935-air-pressure-foot-massager-fda-510k.jpg K212935 - Air Pressure Foot Massager K212935 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Xiamen Simo Electronic Co., Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k212998/ 2022-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k212998-powder-free-nitrile-examination-gloves-fda-510k.jpg K212998 - Powder Free Nitrile Examination Gloves (White, Blue and Black) K212998 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Alcatron Gloves Factory. Cleared Feb 2022. https://www.510kdatabase.net/k213091/ 2022-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k213091-well-life-tensemsheating-stimulator-fda-510k.jpg K213091 - Well-Life TENS/EMS/Heating Stimulator K213091 is a FDA 510(k) cleared neurology medical device. Manufacturer: Well-Life Healthcare Limited. Cleared Feb 2022. https://www.510kdatabase.net/k213286/ 2022-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k213286-eons-nitrile-examination-gloves-powder-fda-510k.jpg K213286 - EONS Nitrile Examination Gloves Powder Free K213286 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Eons Gloves (Thailand) Co., Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k213600/ 2022-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k213600-medical-nitrile-examination-gloves-fda-510k.jpg K213600 - Medical nitrile examination gloves (Model: SH001) K213600 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangxi Sanhao Medical Instruments Co.,Ltd. Cleared Feb 2022. https://www.510kdatabase.net/k213912/ 2022-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k213912-disposable-medical-nitrile-examination-fda-510k.jpg K213912 - Disposable Medical Nitrile Examination Gloves K213912 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Maolin Medical Technology Co., Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k214110/ 2022-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k214110-nitrile-powder-free-blue-patient-fda-510k.jpg K214110 - Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs K214110 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Mah Sing Healthcare Sdn. Bhd.. Cleared Feb 2022. https://www.510kdatabase.net/k201510/ 2022-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k201510-traufix-osteosynthesis-osteotomy-and-fda-510k.jpg K201510 - Traufix osteosynthesis, osteotomy, and arthrodesis devices K201510 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Fixier S.A. DE C.V.. Cleared Feb 2022. https://www.510kdatabase.net/k202644/ 2022-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k202644-acetaminophen-fda-510k.jpg K202644 - Acetaminophen K202644 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Sekisui Diagnostics P.E.I., Inc.. Cleared Feb 2022. https://www.510kdatabase.net/k211746/ 2022-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k211746-pocket-ultrasound-system-fda-510k.jpg K211746 - Pocket Ultrasound System K211746 is a FDA 510(k) cleared radiology medical device. Manufacturer: Guangdong Youkey Medical Co., Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k212212/ 2022-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k212212-multitom-rax-with-true2scale-body-scan-fda-510k.jpg K212212 - Multitom Rax with True2scale Body Scan Option K212212 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions. Cleared Feb 2022. https://www.510kdatabase.net/k212447/ 2022-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k212447-sejoy-hcg-one-step-pregnancy-test-fda-510k.jpg K212447 - SEJOY hCG One Step Pregnancy Test Strip, SEJOY hCG One Step Pregnancy Test Cassette, SEJOY hCG One Step Pregnancy Test Midstream K212447 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Hangzhou Sejoy Electronics & Instruments Co., Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k212627/ 2022-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k212627-true-tulip-true-mis-fda-510k.jpg K212627 - True Tulip, True M.I.S. K212627 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Innovative Surgical Designs, Inc.. Cleared Feb 2022. https://www.510kdatabase.net/k213057/ 2022-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k213057-examvue-duo-fda-510k.jpg K213057 - ExamVue Duo K213057 is a FDA 510(k) cleared radiology medical device. Manufacturer: Jpi Healthcare Co, Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k213079/ 2022-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k213079-ear-thermometer-model-et001-fda-510k.jpg K213079 - Ear Thermometer, Model ET001 K213079 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guangzhou Berrcom Medical Device Co., Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k213306/ 2022-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k213306-powder-free-nitrile-examination-gloves-fda-510k.jpg K213306 - Powder Free Nitrile Examination Gloves, Blue,Test For Use With Chemotherapy Drugs K213306 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zibo Sinocare Plastic Products Co., Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k213319/ 2022-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k213319-viz-aneurysm-viz-anx-fda-510k.jpg K213319 - Viz ANEURYSM, Viz ANX K213319 is a FDA 510(k) cleared radiology medical device. Manufacturer: Viz. Ai, Inc.. Cleared Feb 2022. https://www.510kdatabase.net/k213440/ 2022-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k213440-powder-free-nitrile-examination-gloves-fda-510k.jpg K213440 - Powder Free Nitrile Examination Gloves (Blue, Purple-Blue), Tested for Use with Chemotherapy Drugs K213440 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Luliang Hongruida Health Protection Technology Co., Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k213503/ 2022-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k213503-wrist-blood-pressure-monitor-models-fda-510k.jpg K213503 - Wrist Blood Pressure Monitor, models AOJ-35A, AOJ-35B, AOJ-35C, AOJ-35D, AOJ-35E K213503 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen AOJ Medical Technology Co., Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k213634/ 2022-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k213634-vinylnitrile-blend-exam-glove-fda-510k.jpg K213634 - Vinyl/Nitrile Blend Exam Glove K213634 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Dezhou Hengchang Medical Technology Co., Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k213688/ 2022-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k213688-nitrile-examination-gloves-model-zmg1351-fda-510k.jpg K213688 - Nitrile Examination Gloves (Model: ZMG1351) K213688 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wuhan Zonsen Medical Products Co., Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k213999/ 2022-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k213999-deep-learning-image-reconstruction-fda-510k.jpg K213999 - Deep Learning Image Reconstruction K213999 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems, LLC. Cleared Feb 2022. https://www.510kdatabase.net/k214003/ 2022-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k214003-dental-zirconia-pre-shaded-block-fda-510k.jpg K214003 - Dental Zirconia Pre-shaded Block K214003 is a FDA 510(k) cleared dental medical device. Manufacturer: Shenzhen Yurucheng Dental Materials Co., Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k214005/ 2022-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k214005-zirconia-dental-ceramics-fda-510k.jpg K214005 - Zirconia Dental Ceramics K214005 is a FDA 510(k) cleared dental medical device. Manufacturer: Shenzhen Yurucheng Dental Materials Co., Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k220162/ 2022-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k220162-noveos-immunoanalyzer-system-noveos-fda-510k.jpg K220162 - Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, Alternaria K220162 is a FDA 510(k) cleared immunology medical device. Manufacturer: Hycor Biomedical. Cleared Feb 2022. https://www.510kdatabase.net/k210208/ 2022-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k210208-titan-condoms-fda-510k.jpg K210208 - Titan Condoms K210208 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Titan Condoms, LLC. Cleared Feb 2022. https://www.510kdatabase.net/k210864/ 2022-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k210864-safety-pen-needle-fda-510k.jpg K210864 - Safety Pen Needle K210864 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sandstone Medical (Suzhou), Inc.. Cleared Feb 2022. https://www.510kdatabase.net/k211212/ 2022-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k211212-lofric-elle-fda-510k.jpg K211212 - LoFric Elle K211212 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Dentsply Sirona. Cleared Feb 2022. https://www.510kdatabase.net/k211679/ 2022-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k211679-xtractor-device-fda-510k.jpg K211679 - Xtractor device K211679 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Xcardia Innovation , Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k212586/ 2022-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k212586-amazing-fda-510k.jpg K212586 - Amazing+ K212586 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Amazing Rubber Products Pvt, Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k212824/ 2022-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k212824-bluezone-model-rx-450-air-purifier-fda-510k.jpg K212824 - Bluezone Model RX-450 Air Purifier K212824 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bluezone Products, Inc.. Cleared Feb 2022. https://www.510kdatabase.net/k212977/ 2022-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k212977-super-torque-mb-angiographic-catheter-fda-510k.jpg K212977 - SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands K212977 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corporation. Cleared Feb 2022. https://www.510kdatabase.net/k213107/ 2022-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k213107-powder-free-blue-nitrile-examination-fda-510k.jpg K213107 - Powder Free Blue Nitrile Examination Gloves K213107 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Novid Ppe Sdn. Bhd.. Cleared Feb 2022. https://www.510kdatabase.net/k213625/ 2022-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k213625-vinyl-examination-gloves-fda-510k.jpg K213625 - Vinyl Examination Gloves K213625 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Dezhou Hengchang Medical Technology Co., Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k213647/ 2022-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k213647-durex-patronus-wide-fda-510k.jpg K213647 - Durex Patronus Wide K213647 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Rb Health (Us), LLC. Cleared Feb 2022. https://www.510kdatabase.net/k213689/ 2022-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k213689-voluson-p6-voluson-p8-fda-510k.jpg K213689 - Voluson P6, Voluson P8 K213689 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Feb 2022. https://www.510kdatabase.net/k213710/ 2022-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k213710-da-vinci-fluorescence-imaging-vision-fda-510k.jpg K213710 - da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System K213710 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Feb 2022. https://www.510kdatabase.net/k213972/ 2022-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k213972-mac-lab-recording-systems-altix-fda-510k.jpg K213972 - Mac-Lab Recording Systems AltiX, CardioLab Recording Systems AltiX, ComboLab Recording Systems AltiX, MLCL Client Software AltiX K213972 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Healthcare Information Technologies, Inc.. Cleared Feb 2022. https://www.510kdatabase.net/k213982/ 2022-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k213982-pacific-instruments-orthopedic-fda-510k.jpg K213982 - Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires K213982 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Pacific Instruments. Cleared Feb 2022. https://www.510kdatabase.net/k214022/ 2022-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k214022-accu-chek-softclix-blood-lancing-system-fda-510k.jpg K214022 - Accu-Chek Softclix Blood Lancing System K214022 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Roche Diabetes Care, Inc.. Cleared Feb 2022. https://www.510kdatabase.net/k220124/ 2022-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k220124-yandr-system-voluderm-handpiece-fda-510k.jpg K220124 - YandR System, VoluDerm Handpiece, VoluDerm Tips K220124 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Pollogen, Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k220137/ 2022-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k220137-lunderquist-extra-stiff-wire-guide-fda-510k.jpg K220137 - Lunderquist Extra Stiff Wire Guide K220137 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: William Cook Europe Aps. Cleared Feb 2022. https://www.510kdatabase.net/k220150/ 2022-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k220150-tens-pms-model-sm9126-fda-510k.jpg K220150 - TENS & PMS (Model: SM9126) K220150 is a FDA 510(k) cleared neurology medical device. Manufacturer: Hong Qiangxing (Shenzhen) Electronics Limited. Cleared Feb 2022. https://www.510kdatabase.net/k220277/ 2022-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k220277-digital-intraoral-x-ray-sensor-fda-510k.jpg K220277 - Digital Intraoral X-ray Sensor K220277 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Xpectvision Technology Co., Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k212886/ 2022-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k212886-broncoflex-agile-broncoflex-vortex-fda-510k.jpg K212886 - Broncoflex Agile, Broncoflex Vortex, Screeni K212886 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Axess Vision Technology. Cleared Feb 2022. https://www.510kdatabase.net/k212930/ 2022-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k212930-lumivy-lumbar-ibf-system-fda-510k.jpg K212930 - LumiVy Lumbar IBF System K212930 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Vy Spine, LLC. Cleared Feb 2022. https://www.510kdatabase.net/k213186/ 2022-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k213186-novoflow-reinforced-ureteral-stent-fda-510k.jpg K213186 - NovoFlow Reinforced Ureteral Stent K213186 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Coloplast Corp.. Cleared Feb 2022. https://www.510kdatabase.net/k213533/ 2022-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k213533-sequential-circulators-sc-1004-dl-sc-fda-510k.jpg K213533 - Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL K213533 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Bio Compression Systems, Inc.. Cleared Feb 2022. https://www.510kdatabase.net/k214044/ 2022-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k214044-14hq901g-b-fda-510k.jpg K214044 - 14HQ901G-B K214044 is a FDA 510(k) cleared radiology medical device. Manufacturer: Lg Electronics.Inc. Cleared Feb 2022. https://www.510kdatabase.net/k220136/ 2022-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k220136-treace-medical-concepts-tmc-plating-fda-510k.jpg K220136 - Treace Medical Concepts (TMC) Plating System K220136 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Treace Medical Concepts, Inc.. Cleared Feb 2022. https://www.510kdatabase.net/k220147/ 2022-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k220147-aspiron-s-acp-system-fda-510k.jpg K220147 - Aspiron S ACP System K220147 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: U&I Corporation. Cleared Feb 2022. https://www.510kdatabase.net/k220419/ 2022-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k220419-apapro-desensitizer-fda-510k.jpg K220419 - Apapro Desensitizer K220419 is a FDA 510(k) cleared dental medical device. Manufacturer: Sangi Co, Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k203234/ 2022-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k203234-tslim-x2-insulin-pump-with-fda-510k.jpg K203234 - t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app) K203234 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Tandem Diabetes Care, Inc.. Cleared Feb 2022. https://www.510kdatabase.net/k210229/ 2022-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k210229-sterile-auto-disable-syringes-fda-510k.jpg K210229 - Sterile Auto-Disable Syringes with/without Needle for Single Use K210229 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zhejiang Kangkang Medical-Devices Co., Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k210636/ 2022-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k210636-morpheus-fda-510k.jpg K210636 - Morpheus K210636 is a FDA 510(k) cleared dental medical device. Manufacturer: S4S UK , Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k203793/ 2022-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k203793-rithmid-sd-steerable-diagnostic-fda-510k.jpg K203793 - RithmID-SD Steerable Diagnostic Electrophysiology Catheter K203793 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Synaptic Medical Corporation. Cleared Feb 2022. https://www.510kdatabase.net/k211610/ 2022-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k211610-fogarty-occlusion-catheter-fda-510k.jpg K211610 - Fogarty Occlusion Catheter K211610 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Feb 2022. https://www.510kdatabase.net/k212011/ 2022-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k212011-vinyl-powder-free-examination-glove-fda-510k.jpg K212011 - Vinyl Powder Free Examination Glove K212011 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Top Glove Vietnam Company Limited. Cleared Feb 2022. https://www.510kdatabase.net/k213606/ 2022-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k213606-evoendo-single-use-endoscopy-system-fda-510k.jpg K213606 - EvoEndo Single-Use Endoscopy System K213606 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: EvoEndo, Inc.. Cleared Feb 2022. https://www.510kdatabase.net/k213622/ 2022-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k213622-cionic-neural-sleeve-ns-100-fda-510k.jpg K213622 - Cionic Neural Sleeve NS-100 K213622 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cionic. Cleared Feb 2022. https://www.510kdatabase.net/k203337/ 2022-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k203337-paintb-paintj-fda-510k.jpg K203337 - PainTB, PainTJ K203337 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Ptech Co., Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k211024/ 2022-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k211024-electric-breast-pump-fda-510k.jpg K211024 - Electric Breast Pump K211024 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shantou Huihengqi Electronic Technology Co., Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k211248/ 2022-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k211248-artus-fda-510k.jpg K211248 - ArtUs K211248 is a FDA 510(k) cleared radiology medical device. Manufacturer: Telemed. Cleared Feb 2022. https://www.510kdatabase.net/k211400/ 2022-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k211400-pulse-oximeter-fda-510k.jpg K211400 - Pulse Oximeter K211400 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Beijing Choice Electronic Technology Co., Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k211712/ 2022-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k211712-3-anterior-cervical-plating-system-fda-510k.jpg K211712 - 3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallmark Anterior Plate System, NewBridge Laminoplasty Fixation System, CETRA Anterior Cervical Plate System K211712 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthofix US, LLC. Cleared Feb 2022. https://www.510kdatabase.net/k212180/ 2022-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k212180-wearable-breast-pump-model-s12-fda-510k.jpg K212180 - Wearable Breast Pump (Model S12) K212180 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shenzhen TPH Technology Co., Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k212545/ 2022-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k212545-flexitsystem-knee-osteotomy-system-fda-510k.jpg K212545 - FlexitSystem Knee osteotomy system K212545 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Neosteo. Cleared Feb 2022. https://www.510kdatabase.net/k212570/ 2022-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k212570-osteoplan-system-fda-510k.jpg K212570 - OsteoPlan System K212570 is a FDA 510(k) cleared dental medical device. Manufacturer: Osteomed, LLC. Cleared Feb 2022. https://www.510kdatabase.net/k212622/ 2022-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k212622-zyter-rpm-fda-510k.jpg K212622 - Zyter RPM K212622 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Zyter, Inc.. Cleared Feb 2022. https://www.510kdatabase.net/k212885/ 2022-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k212885-actively-trying-personal-lubricant-fda-510k.jpg K212885 - Actively Trying Personal Lubricant Rose Scented K212885 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: CC Wellness, LLC. Cleared Feb 2022. https://www.510kdatabase.net/k213328/ 2022-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k213328-gamma4-system-gamma3-system-imn-screws-fda-510k.jpg K213328 - Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System K213328 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker GmbH. Cleared Feb 2022. https://www.510kdatabase.net/k213462/ 2022-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k213462-ezray-m18-model-vmx-p400-fda-510k.jpg K213462 - EzRay M18 (Model: VMX-P400) K213462 is a FDA 510(k) cleared radiology medical device. Manufacturer: VATECH Co., Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k213487/ 2022-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k213487-acuson-p500-ultrasound-system-fda-510k.jpg K213487 - ACUSON P500 Ultrasound System K213487 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 2022. https://www.510kdatabase.net/k213603/ 2022-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k213603-signa-artist-evo-fda-510k.jpg K213603 - SIGNA Artist Evo K213603 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare (Tianjin) Company Limited. Cleared Feb 2022. https://www.510kdatabase.net/k213617/ 2022-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k213617-surgical-face-mask-fda-510k.jpg K213617 - Surgical Face Mask K213617 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Megasoft (China) Co., Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k213664/ 2022-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k213664-b-braun-introcan-safety-2-iv-catheter-fda-510k.jpg K213664 - B. Braun Introcan Safety 2 IV Catheter K213664 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Feb 2022. https://www.510kdatabase.net/k213874/ 2022-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k213874-maverick-external-fixation-system-fda-510k.jpg K213874 - MAVERICK External Fixation System K213874 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Feb 2022. https://www.510kdatabase.net/k213890/ 2022-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k213890-imicryl-impression-materials-fda-510k.jpg K213890 - IMICRYL Impression Materials K213890 is a FDA 510(k) cleared dental medical device. Manufacturer: Imicryl Dis Malzemeleri San. VE Tic. A.S.. Cleared Feb 2022. https://www.510kdatabase.net/k202234/ 2022-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k202234-nervalign-nerve-cuff-fda-510k.jpg K202234 - NervAlign Nerve Cuff K202234 is a FDA 510(k) cleared neurology medical device. Manufacturer: Renerve, Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k202728/ 2022-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k202728-action-trackchair-hawk-fda-510k.jpg K202728 - Action Trackchair Hawk K202728 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Action Manufacturing, Inc.. Cleared Feb 2022. https://www.510kdatabase.net/k202926/ 2022-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k202926-micro-catheter-fda-510k.jpg K202926 - Micro Catheter K202926 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shanghai Heartcare Medical Technology Co., Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k203811/ 2022-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k203811-gpc-intraheal-intramedullary-nailing-fda-510k.jpg K203811 - GPC Intraheal Intramedullary Nailing System K203811 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Gpc Medical Limited. Cleared Feb 2022. https://www.510kdatabase.net/k211327/ 2022-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k211327-khelix-steerable-electrophysiology-fda-510k.jpg K211327 - Khelix Steerable Electrophysiology Catheters, Khelix Loop Fixed Electrophysiology Catheters, Khelix Fixed Loop Steerable Electrophysiology Catheters, Khelix Variable Loop Steerable Electrophysiology Catheters K211327 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: CathRx, Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k211570/ 2022-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k211570-zeolite-hemostatic-gauze-fda-510k.jpg K211570 - Zeolite Hemostatic Gauze K211570 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Hangzhou Zeo-Innov Life Technology Co., Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k212971/ 2022-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k212971-npseal-fda-510k.jpg K212971 - NPseal K212971 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Guard Medical, Inc.. Cleared Feb 2022. https://www.510kdatabase.net/k213632/ 2022-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k213632-instylla-delivery-kit-fda-510k.jpg K213632 - Instylla Delivery Kit K213632 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Instylla, Inc.. Cleared Feb 2022. https://www.510kdatabase.net/k220007/ 2022-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k220007-pure-vu-evs-system-fda-510k.jpg K220007 - Pure-Vu EVS System K220007 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Motus GI Medical Technologies , Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k211617/ 2022-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k211617-infrascanner-fda-510k.jpg K211617 - Infrascanner K211617 is a FDA 510(k) cleared neurology medical device. Manufacturer: Infrascan, Inc.. Cleared Feb 2022. https://www.510kdatabase.net/k212167/ 2022-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k212167-r350-guidewire-spectre-guidewire-fda-510k.jpg K212167 - R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire K212167 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vascular Solutions, LLC. Cleared Feb 2022. https://www.510kdatabase.net/k212211/ 2022-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k212211-turnpike-catheter-turnpike-spiral-fda-510k.jpg K212211 - Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheter K212211 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vascular Solutions, LLC. Cleared Feb 2022. https://www.510kdatabase.net/k212213/ 2022-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k212213-xpert-xpress-mvp-genexpert-dx-system-fda-510k.jpg K212213 - Xpert Xpress MVP, GeneXpert Dx System, GeneXpert Infinity System K212213 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Cepheid. Cleared Feb 2022. https://www.510kdatabase.net/k212658/ 2022-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k212658-cloudcath-peritoneal-dialysis-drain-fda-510k.jpg K212658 - CloudCath Peritoneal Dialysis Drain Set Monitoring System K212658 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cloudcath. Cleared Feb 2022. https://www.510kdatabase.net/k212705/ 2022-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k212705-actively-trying-personal-lubricant-fda-510k.jpg K212705 - Actively Trying Personal Lubricant Unfragrance K212705 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: CC Wellness, LLC. Cleared Feb 2022. https://www.510kdatabase.net/k213297/ 2022-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k213297-redline-fda-510k.jpg K213297 - Redline K213297 is a FDA 510(k) cleared dental medical device. Manufacturer: Johns Dental Laboratories. Cleared Feb 2022. https://www.510kdatabase.net/k213311/ 2022-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k213311-lucy-breast-pump-fda-510k.jpg K213311 - Lucy Breast Pump K213311 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Willow Innovations, Inc.. Cleared Feb 2022. https://www.510kdatabase.net/k213313/ 2022-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k213313-veinoflow-scd-model-lbtk-m-i-5006-fda-510k.jpg K213313 - Veinoflow SCD (Model: LBTK-M-I 5006) K213313 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Dalian Labtek Science & Development Co., Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k213573/ 2022-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k213573-pelnac-wound-matrix-fda-510k.jpg K213573 - PELNAC Wound Matrix K213573 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Gunze Limited. Cleared Feb 2022. https://www.510kdatabase.net/k213918/ 2022-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k213918-degen-navigated-instrumentation-fda-510k.jpg K213918 - DeGen Navigated Instrumentation K213918 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Degen Medical. Cleared Feb 2022. https://www.510kdatabase.net/k214011/ 2022-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k214011-catalyft-pl-expandable-interbody-fda-510k.jpg K214011 - Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™ TL Spinal System with Titan nanoLOCK™ Surface Technology Navigated Instruments, and CD Horizon™ Solera™ Voyager™ Spinal System Navigated, Guided, and Powered Drivers K214011 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Feb 2022. https://www.510kdatabase.net/k220108/ 2022-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k220108-sdc4k-information-management-system-fda-510k.jpg K220108 - SDC4K Information Management System with Device and Voice Control Package K220108 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker Endoscopy. Cleared Feb 2022. https://www.510kdatabase.net/k211530/ 2022-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k211530-pathbuilder-steerable-introducer-fda-510k.jpg K211530 - PathBuilder Steerable Introducer K211530 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shanghai Microport EP Medtech Co., Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k213058/ 2022-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k213058-ostar-nitrile-examination-gloves-fda-510k.jpg K213058 - O'Star Nitrile Examination Gloves Powder Free K213058 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Star Investment and Trade Joint Stock Company. Cleared Feb 2022. https://www.510kdatabase.net/k213165/ 2022-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k213165-rapid-fda-510k.jpg K213165 - Rapid K213165 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ischemaview, Inc.. Cleared Feb 2022. https://www.510kdatabase.net/k220047/ 2022-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k220047-acqcross-qx-integrated-transseptal-fda-510k.jpg K220047 - AcQCross Qx Integrated Transseptal Dilator/Needle K220047 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Acutus Medical, Inc.. Cleared Feb 2022. https://www.510kdatabase.net/k201191/ 2022-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k201191-elec-led-fda-510k.jpg K201191 - ELEC-LED K201191 is a FDA 510(k) cleared dental medical device. Manufacturer: Micro-Nx Co., Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k212431/ 2022-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k212431-biomet-answerimpactintegral-distal-fda-510k.jpg K212431 - Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve K212431 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Feb 2022. https://www.510kdatabase.net/k210356/ 2022-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k210356-noris-medical-dental-implants-system-fda-510k.jpg K210356 - Noris Medical Dental Implants System K210356 is a FDA 510(k) cleared dental medical device. Manufacturer: Noris Medical , Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k211417/ 2022-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k211417-f3d-c2-cervical-stand-alone-system-fda-510k.jpg K211417 - F3D-C2 Cervical Stand-Alone System K211417 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corelink, LLC. Cleared Feb 2022. https://www.510kdatabase.net/k212271/ 2022-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k212271-smart-sync-fda-510k.jpg K212271 - smart-sync K212271 is a FDA 510(k) cleared radiology medical device. Manufacturer: Northh Medical GmbH. Cleared Feb 2022. https://www.510kdatabase.net/k212419/ 2022-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k212419-magnifico-open-magnifico-msk-fda-510k.jpg K212419 - Magnifico Open, Magnifico MSK K212419 is a FDA 510(k) cleared radiology medical device. Manufacturer: Esaote, S.P.A.. Cleared Feb 2022. https://www.510kdatabase.net/k212654/ 2022-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k212654-micro-c-medical-imaging-system-m01-fda-510k.jpg K212654 - Micro C Medical Imaging System, M01 K212654 is a FDA 510(k) cleared radiology medical device. Manufacturer: Oxos Medical, Inc.. Cleared Feb 2022. https://www.510kdatabase.net/k212721/ 2022-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k212721-genex-bone-graft-substitute-fda-510k.jpg K212721 - Genex Bone Graft Substitute K212721 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biocomposites, Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k212724/ 2022-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k212724-bd-vacutainer-ultratouch-push-button-fda-510k.jpg K212724 - BD Vacutainer UltraTouch Push Button Blood Collection Set K212724 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson and Company. Cleared Feb 2022. https://www.510kdatabase.net/k212774/ 2022-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k212774-vensure-lightguide-fda-510k.jpg K212774 - VenSure LightGuide K212774 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Intersect Ent.. Cleared Feb 2022. https://www.510kdatabase.net/k212849/ 2022-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k212849-vitek-2-ast-gram-positive-linezolid-05-fda-510k.jpg K212849 - VITEK 2 AST-Gram Positive Linezolid (<=0.5 – >=8 µg/mL) K212849 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Biom?rieux, Inc.. Cleared Feb 2022. https://www.510kdatabase.net/k213569/ 2022-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k213569-hollywood-spectra-laser-system-fda-510k.jpg K213569 - HOLLYWOOD SPECTRA Laser System K213569 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lutronic Corporation. Cleared Feb 2022. https://www.510kdatabase.net/k213777/ 2022-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k213777-stryker-resorbable-fixation-system-fda-510k.jpg K213777 - Stryker Resorbable Fixation System K213777 is a FDA 510(k) cleared dental medical device. Manufacturer: Stryker Leibinger Micro Implants. Cleared Feb 2022. https://www.510kdatabase.net/k213801/ 2022-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k213801-veuron-brain-pab2-fda-510k.jpg K213801 - Veuron-Brain-pAb2 K213801 is a FDA 510(k) cleared radiology medical device. Manufacturer: Heuron Co., Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k213938/ 2022-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k213938-revolution-ascend-fda-510k.jpg K213938 - Revolution Ascend K213938 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare Japan Corporation. Cleared Feb 2022. https://www.510kdatabase.net/k214062/ 2022-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k214062-radialis-pet-camera-fda-510k.jpg K214062 - Radialis PET Camera K214062 is a FDA 510(k) cleared radiology medical device. Manufacturer: Radialis, Inc.. Cleared Feb 2022. https://www.510kdatabase.net/k220020/ 2022-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k220020-cryo-7-fda-510k.jpg K220020 - Cryo 7 K220020 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Zimmer Medizinsysteme GmbH. Cleared Feb 2022. https://www.510kdatabase.net/k220053/ 2022-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k220053-diathermic-slitter-flushknife-dk2620ji-fda-510k.jpg K220053 - Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI K220053 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fujifilm Corporation. Cleared Feb 2022. https://www.510kdatabase.net/k220070/ 2022-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k220070-myday-stenfilcon-a-soft-hydrophilic-fda-510k.jpg K220070 - MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens K220070 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: CooperVision, Inc.. Cleared Feb 2022. https://www.510kdatabase.net/k220098/ 2022-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k220098-digital-radiography-cxdi-pro-digital-fda-510k.jpg K220098 - Digital Radiography CXDI-Pro, Digital Radiography D1 K220098 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon, Inc.. Cleared Feb 2022. https://www.510kdatabase.net/k203335/ 2022-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k203335-mectascrew-extension-fda-510k.jpg K203335 - MectaScrew Extension K203335 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Feb 2022. https://www.510kdatabase.net/k210826/ 2022-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k210826-healing-abutment-cover-screw-fda-510k.jpg K210826 - Healing Abutment, Cover Screw K210826 is a FDA 510(k) cleared dental medical device. Manufacturer: Megagen Implant Co., Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k211822/ 2022-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k211822-lifepath-remote-patient-monitoring-fda-510k.jpg K211822 - LifePath Remote Patient Monitoring Platform K211822 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Elastic Care Incorporated. Cleared Feb 2022. https://www.510kdatabase.net/k212382/ 2022-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k212382-ambu-ascope-gastro-ambu-abox2-fda-510k.jpg K212382 - Ambu® aScope™ Gastro, Ambu® aBox™2 K212382 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ambu A/S. Cleared Feb 2022. https://www.510kdatabase.net/k213824/ 2022-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k213824-sonopet-iq-ultrasonic-aspirator-system-fda-510k.jpg K213824 - Sonopet iQ Ultrasonic Aspirator System K213824 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker Corporation. Cleared Feb 2022. https://www.510kdatabase.net/k213976/ 2022-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k213976-contour-protgai-fda-510k.jpg K213976 - Contour ProtégéAI K213976 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mim Software, Inc.. Cleared Feb 2022. https://www.510kdatabase.net/k220071/ 2022-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k220071-soniquence-reusable-neutral-plate-fda-510k.jpg K220071 - Soniquence Reusable Neutral Plate K220071 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Soniquence, LLC. Cleared Feb 2022. https://www.510kdatabase.net/k201403/ 2022-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k201403-nattrol-bd-max-vaginal-panel-external-fda-510k.jpg K201403 - NATtrol BD MAX Vaginal Panel External Controls K201403 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Zeptometrix. Cleared Feb 2022. https://www.510kdatabase.net/k203586/ 2022-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k203586-endoserter-pl-fda-510k.jpg K203586 - EndoSerter-PL K203586 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Corneagen, Inc.. Cleared Feb 2022. https://www.510kdatabase.net/k210832/ 2022-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k210832-evoclean-cleansert-ultrasonic-insert-fda-510k.jpg K210832 - EVOCLEAN CLEANsert Ultrasonic Insert K210832 is a FDA 510(k) cleared dental medical device. Manufacturer: Ttbio Corp.. Cleared Feb 2022. https://www.510kdatabase.net/k211228/ 2022-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k211228-rosso-fda-510k.jpg K211228 - Rosso K211228 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Quanta System Spa. Cleared Feb 2022. https://www.510kdatabase.net/k211603/ 2022-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k211603-aquamax-etafilcon-a-daily-disposable-fda-510k.jpg K211603 - Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses K211603 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Pegavision Corporation. Cleared Feb 2022. https://www.510kdatabase.net/k212079/ 2022-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k212079-teesuvac-breast-biopsy-device-mark-1-fda-510k.jpg K212079 - TeesuVac Breast Biopsy Device Mark 1 K212079 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Teesuvac Aps. Cleared Feb 2022. https://www.510kdatabase.net/k213554/ 2022-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k213554-sentient-manufacturing-laser-fiber-fda-510k.jpg K213554 - Sentient Manufacturing Laser Fiber K213554 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sentient Manufacturing , LLC. Cleared Feb 2022. https://www.510kdatabase.net/k213812/ 2022-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k213812-palacos-mv-pro-fda-510k.jpg K213812 - PALACOS MV pro K213812 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Heraeus Medical GmbH. Cleared Feb 2022. https://www.510kdatabase.net/k213814/ 2022-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k213814-viveve-20-system-fda-510k.jpg K213814 - Viveve 2.0 System K213814 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Viveve, Inc.. Cleared Feb 2022. https://www.510kdatabase.net/k203088/ 2022-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k203088-infinity-acute-care-system-iacs-fda-510k.jpg K203088 - Infinity Acute Care System (IACS) Monitoring System K203088 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Draeger Medical Systems, Inc.. Cleared Feb 2022. https://www.510kdatabase.net/k210727/ 2022-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k210727-hotdog-warming-mattress-return-electrode-fda-510k.jpg K210727 - HotDog Warming Mattress + Return Electrode K210727 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Augustine Temperature Management, LLC. Cleared Feb 2022. https://www.510kdatabase.net/k211701/ 2022-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k211701-x-guide-surgical-navigation-system-fda-510k.jpg K211701 - X-Guide® Surgical Navigation System K211701 is a FDA 510(k) cleared dental medical device. Manufacturer: X-Nav Technologies, LLC. Cleared Feb 2022. https://www.510kdatabase.net/k212410/ 2022-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k212410-vitavitro-sperm-washing-medium-fda-510k.jpg K212410 - VitaVitro Sperm Washing Medium, VitaVitro Sperm Gradient Medium K212410 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shenzhen Vitavitro Biotech Co., Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k212611/ 2022-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k212611-co2-laser-equipment-fda-510k.jpg K212611 - CO2 Laser Equipment K212611 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Beijing Globalipl Development Co., Ltd.. Cleared Feb 2022. https://www.510kdatabase.net/k213565/ 2022-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k213565-jeti-aio-peripheral-thrombectomy-system-fda-510k.jpg K213565 - JETi AIO Peripheral Thrombectomy System K213565 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Walk Vascular, LLC. Cleared Feb 2022. https://www.510kdatabase.net/k213701/ 2022-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k213701-exeter-x3-rimfit-cup-fda-510k.jpg K213701 - Exeter® X3® RimFit® Cup K213701 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp., Dba Stryker Orthopaedics. Cleared Feb 2022. https://www.510kdatabase.net/k213830/ 2022-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k213830-home-use-hair-removal-device-model-fda-510k.jpg K213830 - Home use hair removal device, model: Precise Touch Pro K213830 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Iluminage Beauty Co., Limited. Cleared Feb 2022. https://www.510kdatabase.net/k220257/ 2022-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k220257-permadyne-fda-510k.jpg K220257 - Permadyne K220257 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Deutschland GmbH. Cleared Feb 2022. https://www.510kdatabase.net/k203272/ 2022-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k203272-alltest-pregnancy-rapid-combo-test-fda-510k.jpg K203272 - Alltest Pregnancy Rapid Combo Test Cassette K203272 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Hangzhou AllTest Biotech Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k211628/ 2022-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k211628-mis-precision-chevron-bunion-system-fda-510k.jpg K211628 - MIS Precision Chevron Bunion System K211628 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Relja Innovations, LLC. Cleared Jan 2022. https://www.510kdatabase.net/k213188/ 2022-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k213188-primary-relief-fda-510k.jpg K213188 - Primary Relief K213188 is a FDA 510(k) cleared neurology medical device. Manufacturer: Dyansys, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k213401/ 2022-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k213401-diaplus-universal-fda-510k.jpg K213401 - DIAPLUS Universal K213401 is a FDA 510(k) cleared dental medical device. Manufacturer: DiaDent Group International. Cleared Jan 2022. https://www.510kdatabase.net/k213908/ 2022-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k213908-skr-3000-fda-510k.jpg K213908 - SKR 3000 K213908 is a FDA 510(k) cleared radiology medical device. Manufacturer: Konica Minolta, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k220023/ 2022-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k220023-8mm-monopolar-curved-scissors-fda-510k.jpg K220023 - 8mm Monopolar Curved Scissors K220023 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k203260/ 2022-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k203260-syngoct-brain-hemorrhage-fda-510k.jpg K203260 - syngo.CT Brain Hemorrhage K203260 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k203395/ 2022-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k203395-platform-treatment-system-fda-510k.jpg K203395 - Platform treatment system K203395 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shanghai Apolo Medical Technology Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k211096/ 2022-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k211096-optiflow-oxygen-kit-fda-510k.jpg K211096 - Optiflow Oxygen Kit K211096 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Fisher &Paykel Healthcare , Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k212120/ 2022-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k212120-surgical-masks-fda-510k.jpg K212120 - Surgical Masks K212120 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hubei Xinxin Non-Woven Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k212341/ 2022-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k212341-quantum-perfusion-blood-oxygenator-fda-510k.jpg K212341 - Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2U, Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT160-C1U,Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2U K212341 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Qura S.R.L. Cleared Jan 2022. https://www.510kdatabase.net/k212533/ 2022-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k212533-blx-wb-50-l18-55-and-65-mm-l14-and-l16-fda-510k.jpg K212533 - BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants K212533 is a FDA 510(k) cleared dental medical device. Manufacturer: Institut Straumann AG. Cleared Jan 2022. https://www.510kdatabase.net/k212598/ 2022-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k212598-ihealth-infrared-ear-thermometer-pt5-fda-510k.jpg K212598 - iHealth infrared Ear thermometer PT5 K212598 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Andon Health Co, Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k212648/ 2022-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k212648-vitros-immunodiagnostic-products-ck-mb-fda-510k.jpg K212648 - VITROS Immunodiagnostic Products CK-MB Reagent Pack K212648 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Ortho-Clinical Diagnostics. Cleared Jan 2022. https://www.510kdatabase.net/k212943/ 2022-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k212943-synthecel-dura-repair-fda-510k.jpg K212943 - SyntheCel Dura Repair K212943 is a FDA 510(k) cleared neurology medical device. Manufacturer: Synthes USA Products, LLC. Cleared Jan 2022. https://www.510kdatabase.net/k213082/ 2022-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k213082-non-contact-infrared-thermometer-fda-510k.jpg K213082 - Non-contact Infrared Thermometer, Models JXB-315, JXB-319, JXB-320, JXB-311 K213082 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guangzhou Berrcom Medical Device Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k213093/ 2022-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k213093-step-1-pumetch-fda-510k.jpg K213093 - STEP-1 PumEtch K213093 is a FDA 510(k) cleared dental medical device. Manufacturer: Rounding Third, LLC. Cleared Jan 2022. https://www.510kdatabase.net/k213142/ 2022-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k213142-biodegradable-powder-free-flock-lined-fda-510k.jpg K213142 - Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors, Tested for use with Chemotherapy drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl Citrate Simulated Gastric Acid Solution K213142 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shen Wei (Usa), Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k213317/ 2022-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k213317-shinevac-smoke-evacuation-pencil-fda-510k.jpg K213317 - ShinEvac Smoke Evacuation Pencil K213317 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shining World Health Care Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k213325/ 2022-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k213325-disposable-medical-nitrile-examination-fda-510k.jpg K213325 - Disposable Medical Nitrile Examination Gloves- Tested for Use With Chemotherapy Drugs K213325 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Anhui Xinyisheng Medical Technology Co.,Ltd. Cleared Jan 2022. https://www.510kdatabase.net/k213523/ 2022-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k213523-x-cube-i8-x-cube-i9-fda-510k.jpg K213523 - X-CUBE i8, X-CUBE i9 K213523 is a FDA 510(k) cleared radiology medical device. Manufacturer: Alpinion Medical Systems Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k214106/ 2022-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k214106-quikpass-catheter-fda-510k.jpg K214106 - QuikPass Catheter K214106 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Traverse Vascular, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k203768/ 2022-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k203768-omnipod-5-ace-pump-pod-fda-510k.jpg K203768 - Omnipod 5 ACE Pump (Pod) K203768 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Insulet Corporation. Cleared Jan 2022. https://www.510kdatabase.net/k203772/ 2022-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k203772-omnipod-5-smartbolus-calculator-fda-510k.jpg K203772 - Omnipod 5 SmartBolus Calculator K203772 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Insulet Corporation. Cleared Jan 2022. https://www.510kdatabase.net/k203774/ 2022-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k203774-smartadjust-technology-fda-510k.jpg K203774 - SmartAdjust technology K203774 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Insulet Corporation. Cleared Jan 2022. https://www.510kdatabase.net/k210360/ 2022-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k210360-neuro-plating-system-neuro-plating-fda-510k.jpg K210360 - Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro Plating System-Packaging unit(NSP-001 and 10 models), Neuro Plating System-Sterile Kit(TCN-011 and 69 models), Neuro Plating System-Screws(N15A03 and 11 models) K210360 is a FDA 510(k) cleared neurology medical device. Manufacturer: Osteonic Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k211210/ 2022-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k211210-sterile-auto-disable-syringes-fda-510k.jpg K211210 - Sterile Auto-Disable Syringes with/without Needle for Single Use K211210 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Azur Medical Company, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k211436/ 2022-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k211436-intermittent-catheter-not-finalized-fda-510k.jpg K211436 - Intermittent Catheter (Not Finalized) K211436 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hollister Incorporated. Cleared Jan 2022. https://www.510kdatabase.net/k211589/ 2022-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k211589-vascuchek-kit-vascuchek-transceiver-fda-510k.jpg K211589 - VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger K211589 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Remington Medical, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k211941/ 2022-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k211941-9line-fda-510k.jpg K211941 - 9Line K211941 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Energetic Designs, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k212312/ 2022-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k212312-ra-t59-wrist-blood-pressure-monitor-fda-510k.jpg K212312 - RA-T59 Wrist blood pressure monitor K212312 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Lotusnine Medical Limited. Cleared Jan 2022. https://www.510kdatabase.net/k212373/ 2022-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k212373-simsize-fda-510k.jpg K212373 - Sim&Size K212373 is a FDA 510(k) cleared neurology medical device. Manufacturer: Sim&Cure. Cleared Jan 2022. https://www.510kdatabase.net/k213211/ 2022-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k213211-carolina-liquid-chemistries-cocaine-fda-510k.jpg K213211 - Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System K213211 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Carolina Liquid Chemistries Corp.. Cleared Jan 2022. https://www.510kdatabase.net/k213475/ 2022-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k213475-elevo-snoring-intervention-set-fda-510k.jpg K213475 - Elevo Snoring Intervention Set K213475 is a FDA 510(k) cleared dental medical device. Manufacturer: Zelegent, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k213489/ 2022-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k213489-wishbone-medical-plate-and-screw-fda-510k.jpg K213489 - Wishbone Medical Plate and Screw System: 3.0mm Screws and 7-Hole Straight Fibula Plate K213489 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wishbone Medical, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k213493/ 2022-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k213493-fortilink-with-tiplus-technology-fda-510k.jpg K213493 - Fortilink with TiPlus Technology K213493 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paradigm Spine. Cleared Jan 2022. https://www.510kdatabase.net/k213771/ 2022-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k213771-merlin-aspiration-system-fda-510k.jpg K213771 - Merlin Aspiration System K213771 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Mivi Neurovascular, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k202914/ 2022-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k202914-sternafuse-fixation-system-fda-510k.jpg K202914 - SternaFuse Fixation System K202914 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Fusion Innovations, LLC. Cleared Jan 2022. https://www.510kdatabase.net/k210101/ 2022-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k210101-american-made-surgical-mask-fda-510k.jpg K210101 - American-Made Surgical Mask K210101 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Armbrust, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k211219/ 2022-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k211219-lassostar-nav-circular-mapping-catheter-fda-510k.jpg K211219 - LASSOSTAR NAV Circular Mapping Catheter K211219 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biosense Webster, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k212610/ 2022-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k212610-surgical-face-mask-fda-510k.jpg K212610 - Surgical Face Mask K212610 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Foshan Nanhai Plus Medical Co, Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k212771/ 2022-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k212771-lightstim-elipsa-fda-510k.jpg K212771 - LightStim Elipsa K212771 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Led Intellectual Properties, LLC. Cleared Jan 2022. https://www.510kdatabase.net/k212868/ 2022-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k212868-jfil-ureteral-stents-jfil-ureteral-fda-510k.jpg K212868 - JFil Ureteral Stents, JFil Ureteral Stents ECO KIT K212868 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Rocamed Sam. Cleared Jan 2022. https://www.510kdatabase.net/k212938/ 2022-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k212938-vitalograph-model-6000-alpha-fda-510k.jpg K212938 - Vitalograph Model 6000 Alpha K212938 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Vitalograph (Ireland) , Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k213591/ 2022-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k213591-anthem-fracture-system-fda-510k.jpg K213591 - ANTHEM® Fracture System K213591 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k213692/ 2022-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k213692-smoothskin-pure-mini-fda-510k.jpg K213692 - SmoothSkin Pure Mini K213692 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cyden Limited. Cleared Jan 2022. https://www.510kdatabase.net/k201323/ 2022-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k201323-inno-sla-submerged-implant-system-fda-510k.jpg K201323 - INNO SLA Submerged Implant System K201323 is a FDA 510(k) cleared dental medical device. Manufacturer: Cowellmedi Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k211355/ 2022-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k211355-icare-home2-fda-510k.jpg K211355 - iCare HOME2 K211355 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Icare Finland OY. Cleared Jan 2022. https://www.510kdatabase.net/k212173/ 2022-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k212173-hdh-treatment-planning-system-fda-510k.jpg K212173 - HDH Treatment Planning System K212173 is a FDA 510(k) cleared dental medical device. Manufacturer: Cdb Corporation. Cleared Jan 2022. https://www.510kdatabase.net/k213347/ 2022-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k213347-adi-medical-surgical-face-mask-fda-510k.jpg K213347 - ADI Medical Surgical Face Mask K213347 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Asia Dynamics Inc., D/B/A Adi Medical. Cleared Jan 2022. https://www.510kdatabase.net/k211482/ 2022-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k211482-disposable-syringe-with-needle-fda-510k.jpg K211482 - Disposable Syringe with Needle K211482 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shandong Qinkai Medical Industry Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k212333/ 2022-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k212333-aplio-i900i800i700-diagnostic-fda-510k.jpg K212333 - Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5 K212333 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Jan 2022. https://www.510kdatabase.net/k213639/ 2022-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k213639-revaclear-500-revaclear-400-revaclear-fda-510k.jpg K213639 - Revaclear 500, Revaclear 400, Revaclear 300 K213639 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corporation. Cleared Jan 2022. https://www.510kdatabase.net/k213780/ 2022-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k213780-digital-radiography-cxdi-elite-digital-fda-510k.jpg K213780 - DIGITAL RADIOGRAPHY CXDI-Elite, DIGITAL RADIOGRAPHY E1 K213780 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k210463/ 2022-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k210463-thermoplastic-elastomer-tpe-hybrid-fda-510k.jpg K210463 - Thermoplastic Elastomer (TPE) Hybrid Examination Glove K210463 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Xuzhou Full Sun Medical Products , Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k210810/ 2022-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k210810-steiking-packaging-for-medical-devices-fda-510k.jpg K210810 - Steiking Packaging for Medical Devices K210810 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wipak OY. Cleared Jan 2022. https://www.510kdatabase.net/k212111/ 2022-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k212111-myflon-surgical-mask-level-3-fda-510k.jpg K212111 - Myflon Surgical Mask Level 3 K212111 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi. Cleared Jan 2022. https://www.510kdatabase.net/k213970/ 2022-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k213970-d-care-surgical-face-mask-3-ply-d-care-fda-510k.jpg K213970 - D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply K213970 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Danameco Medical Joint Stock Corporation. Cleared Jan 2022. https://www.510kdatabase.net/k191105/ 2022-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k191105-e-throne-folding-wheelchair-model-et-fda-510k.jpg K191105 - e-Throne Folding Wheelchair, Model: ET-12F22 K191105 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Golden Motor Technology Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k203293/ 2022-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k203293-abbott-medical-grounding-pad-model-rf-fda-510k.jpg K203293 - Abbott Medical Grounding Pad, model RF-DGP-IS K203293 is a FDA 510(k) cleared neurology medical device. Manufacturer: Abbott Medical. Cleared Jan 2022. https://www.510kdatabase.net/k203761/ 2022-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k203761-paramotion-fda-510k.jpg K203761 - ParaMotion K203761 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Powerbasetec GmbH. Cleared Jan 2022. https://www.510kdatabase.net/k211752/ 2022-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k211752-infrared-thermometer-fda-510k.jpg K211752 - Infrared Thermometer K211752 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Beijing Choice Electronic Technology Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k211864/ 2022-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k211864-powder-free-nitrile-patient-fda-510k.jpg K211864 - Powder Free Nitrile Patient Examination Gloves, Blue Color K211864 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Siyang Jaysun Medtech Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k212594/ 2022-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k212594-ossiofiber-staple-fda-510k.jpg K212594 - OSSIOfiber® Staple K212594 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OSSIO , Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k212991/ 2022-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k212991-osteorevive-fda-510k.jpg K212991 - Osteorevive K212991 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Bone Solutions, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k213044/ 2022-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k213044-nitrile-examination-gloves-fda-510k.jpg K213044 - Nitrile Examination Gloves K213044 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Huayuan Medical Technology Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k213343/ 2022-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k213343-saremco-print-crowntec-fda-510k.jpg K213343 - Saremco Print CROWNTEC K213343 is a FDA 510(k) cleared dental medical device. Manufacturer: Saremco Dental AG. Cleared Jan 2022. https://www.510kdatabase.net/k213412/ 2022-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k213412-verify-steam-integrating-indicator-fda-510k.jpg K213412 - VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM K213412 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Steris Corparation. Cleared Jan 2022. https://www.510kdatabase.net/k213470/ 2022-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k213470-perla-tl-posterior-osteosynthesis-system-fda-510k.jpg K213470 - PERLA® TL Posterior Osteosynthesis System K213470 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spineart. Cleared Jan 2022. https://www.510kdatabase.net/k213673/ 2022-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k213673-b-one-mobio-total-knee-system-fda-510k.jpg K213673 - b-ONE MOBIO Total Knee System K213673 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: B-One Ortho, Corp.. Cleared Jan 2022. https://www.510kdatabase.net/k213696/ 2022-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k213696-ethicon-megadyne-electrosurgical-fda-510k.jpg K213696 - ETHICON Megadyne Electrosurgical Generator K213696 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Megadyne Medical Products, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k214030/ 2022-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k214030-universal-dr-1748-fda-510k.jpg K214030 - Universal DR 1748 K214030 is a FDA 510(k) cleared radiology medical device. Manufacturer: Konica Minolta Healthcare Americas, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/den200059/ 2022-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/den200059-pomcpcsk1lepr-cdx-panel-fda-510k.jpg DEN200059 - POMC/PCSK1/LEPR CDx Panel DEN200059 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Preventiongenetics, LLC. Cleared Jan 2022. https://www.510kdatabase.net/k203161/ 2022-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k203161-surgical-face-mask-fda-510k.jpg K203161 - Surgical Face Mask K203161 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wuhan Raytex Protection Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k210259/ 2022-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k210259-parkell-self-adhesive-cement-fda-510k.jpg K210259 - Parkell Self-Adhesive Cement K210259 is a FDA 510(k) cleared dental medical device. Manufacturer: Parkell, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k211333/ 2022-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k211333-kidney-assist-transport-fda-510k.jpg K211333 - KIDNEY ASSIST-transport K211333 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Xvivo Perfusion AB. Cleared Jan 2022. https://www.510kdatabase.net/k212357/ 2022-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k212357-surgical-isolation-gown-fda-510k.jpg K212357 - Surgical isolation gown K212357 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wuhan Zonsen Medical Products Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k212458/ 2022-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k212458-flexible-video-uretero-renoscope-ssu-fda-510k.jpg K212458 - Flexible Video-Uretero-Renoscope SSU System K212458 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Karl Storz Endoscopy America. Cleared Jan 2022. https://www.510kdatabase.net/k212592/ 2022-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k212592-gas-chex-indicator-fda-510k.jpg K212592 - Gas-Chex Indicator K212592 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Propper Manufacturing Co., Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k212748/ 2022-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k212748-disposable-dual-action-tissue-clip-fda-510k.jpg K212748 - Disposable Dual Action Tissue Clip K212748 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Micro-Tech (Nanjing) Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k212884/ 2022-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k212884-electric-breast-pump-fda-510k.jpg K212884 - Electric breast pump K212884 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Dongguan Rongfeng Medical Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k212941/ 2022-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k212941-porous-patella-fda-510k.jpg K212941 - Porous Patella K212941 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Encore Medical, L.P. Dba Djo Surgical. Cleared Jan 2022. https://www.510kdatabase.net/k213075/ 2022-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k213075-goody-gloves-wincare-tbg-gloves-fda-510k.jpg K213075 - Goody Gloves, Wincare, TBG Gloves K213075 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Thai Rubber Gloves Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k213356/ 2022-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k213356-entuit-peg-entuit-pegj-fda-510k.jpg K213356 - Entuit PEG, Entuit PEGJ K213356 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Wilson-Cook Medical, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k213668/ 2022-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k213668-signa-hero-fda-510k.jpg K213668 - SIGNA Hero K213668 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare (Ge Medical Systems, LLC). Cleared Jan 2022. https://www.510kdatabase.net/k213709/ 2022-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k213709-signa-petmr-fda-510k.jpg K213709 - SIGNA PET/MR K213709 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems, LLC. Cleared Jan 2022. https://www.510kdatabase.net/k214019/ 2022-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k214019-syngoct-extended-functionality-fda-510k.jpg K214019 - syngo.CT Extended Functionality K214019 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k214084/ 2022-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k214084-hyperion-x9-pro-newtom-giano-hr-x-fda-510k.jpg K214084 - hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS K214084 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cefla S.C.. Cleared Jan 2022. https://www.510kdatabase.net/k203072/ 2022-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k203072-franz-zirconia-dental-crown-fda-510k.jpg K203072 - Franz Zirconia Dental Crown K203072 is a FDA 510(k) cleared dental medical device. Manufacturer: Franz Biotech, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k210747/ 2022-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k210747-caption-interpretation-automated-fda-510k.jpg K210747 - Caption Interpretation Automated Ejection Fraction Software K210747 is a FDA 510(k) cleared radiology medical device. Manufacturer: Caption Health. Cleared Jan 2022. https://www.510kdatabase.net/k211003/ 2022-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k211003-showar-blue-nitrile-powder-free-fda-510k.jpg K211003 - SHOWA(R) Blue Nitrile Powder Free Medical Examination Glove K211003 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Showa Best Glove, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k211330/ 2022-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k211330-r3-large-head-liners-fda-510k.jpg K211330 - R3 Large Head Liners K211330 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k211532/ 2022-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k211532-arm-blood-pressure-monitor-model-ob30-fda-510k.jpg K211532 - Arm Blood Pressure Monitor, model OB30, OB31, OB32, OB33 K211532 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Yibin Junxin Electronics Technology Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k211613/ 2022-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k211613-stern-fix-sternal-stabilization-system-fda-510k.jpg K211613 - Stern Fix Sternal Stabilization System K211613 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Neos Surgery S.L. Cleared Jan 2022. https://www.510kdatabase.net/k211709/ 2022-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k211709-biotres-fda-510k.jpg K211709 - Biotres K211709 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biotricity. Cleared Jan 2022. https://www.510kdatabase.net/k212012/ 2022-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k212012-follicle-clarity-fda-510k.jpg K212012 - Follicle Clarity K212012 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cycle Clarity. Cleared Jan 2022. https://www.510kdatabase.net/k212576/ 2022-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k212576-mdx-chex-for-bcid2-fda-510k.jpg K212576 - MDx-Chex for BCID2 K212576 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Streck, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k212581/ 2022-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k212581-variax-2-distal-radius-system-variax-2-fda-510k.jpg K212581 - VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System K212581 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker GmbH. Cleared Jan 2022. https://www.510kdatabase.net/k212650/ 2022-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k212650-celeris-disposable-sinus-debrider-fda-510k.jpg K212650 - Celeris, Disposable Sinus Debrider K212650 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Gyrus Acmi, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k212683/ 2022-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k212683-global-icon-stemless-shoulder-system-fda-510k.jpg K212683 - GLOBAL ICON Stemless Shoulder System K212683 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy(Ireland). Cleared Jan 2022. https://www.510kdatabase.net/k212826/ 2022-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k212826-disposable-medical-mask-fda-510k.jpg K212826 - Disposable Medical Mask K212826 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Nanfang Medical Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k213227/ 2022-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k213227-powder-free-nitrile-examination-glove-fda-510k.jpg K213227 - Powder free Nitrile Examination Glove-(Test for use with Chemotherapy Drugs) K213227 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Uweport, LLC. Cleared Jan 2022. https://www.510kdatabase.net/k213424/ 2022-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k213424-jabra-enhance-plus-fda-510k.jpg K213424 - Jabra Enhance Plus K213424 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: GN Hearing A/S. Cleared Jan 2022. https://www.510kdatabase.net/k213438/ 2022-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k213438-3d-bolus-software-application-3d-fda-510k.jpg K213438 - 3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory K213438 is a FDA 510(k) cleared radiology medical device. Manufacturer: Adaptiiv. Cleared Jan 2022. https://www.510kdatabase.net/k213447/ 2022-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k213447-lllt-laser-hair-growth-cap-model-hair-fda-510k.jpg K213447 - LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210. K213447 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Cosbeauty Technology Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k214059/ 2022-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k214059-corelink-navigation-instruments-fda-510k.jpg K214059 - CoreLink Navigation Instruments K214059 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corelink, LLC. Cleared Jan 2022. https://www.510kdatabase.net/k201044/ 2022-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k201044-chirana-insulin-syringes-fda-510k.jpg K201044 - CHIRANA Insulin Syringes K201044 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Chirana T. Injecta. Cleared Jan 2022. https://www.510kdatabase.net/k210679/ 2022-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k210679-medical-face-mask-fda-510k.jpg K210679 - Medical Face Mask K210679 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wuxi Yushou Medical Appliances Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k212503/ 2022-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k212503-hp458e-electrically-powered-wheelchair-fda-510k.jpg K212503 - HP458E Electrically Powered Wheelchair K212503 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Kunshan Hi-Fortune Health Products Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k212713/ 2022-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k212713-air-compression-leg-massager-hy-1117a-fda-510k.jpg K212713 - Air compression leg massager HY-1117A K212713 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Xiamen High Top Electronic Technology Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k212842/ 2022-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k212842-microvolume-luer-access-device-fda-510k.jpg K212842 - Microvolume Luer Access Device K212842 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k213216/ 2022-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k213216-qualis-linofilcon-a-soft-hydrophilic-fda-510k.jpg K213216 - Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens K213216 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Unicon Optical Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k213572/ 2022-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k213572-juniortho-plating-system-fda-510k.jpg K213572 - JuniOrtho Plating System™ K213572 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthofix Srl. Cleared Jan 2022. https://www.510kdatabase.net/k213781/ 2022-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k213781-attune-porous-fixed-bearing-tibial-fda-510k.jpg K213781 - ATTUNE® Porous Fixed Bearing Tibial Base with AFFIXIUM™ 3DP K213781 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Ireland UC. Cleared Jan 2022. https://www.510kdatabase.net/k212994/ 2022-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k212994-medical-face-mask-fda-510k.jpg K212994 - Medical Face Mask K212994 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guangzhou Quantum Laser Intelligent Equipment Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k211833/ 2022-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k211833-disposable-medical-face-mask-fda-510k.jpg K211833 - Disposable Medical Face Mask K211833 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zhejiang the Purples Protective Products Co.,Ltd. Cleared Jan 2022. https://www.510kdatabase.net/k211980/ 2022-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k211980-signa-prime-fda-510k.jpg K211980 - SIGNA Prime K211980 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare (Tianjin) Company Limited. Cleared Jan 2022. https://www.510kdatabase.net/k213920/ 2022-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k213920-kangbeier-surgical-mask-model-kbr-1001-fda-510k.jpg K213920 - Kangbeier Surgical Mask (Model: KBR-1001) K213920 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Xinxiang Kangbeier Medical Technology Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k211360/ 2022-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k211360-disposable-nitrile-powder-free-fda-510k.jpg K211360 - Disposable Nitrile Powder Free Examination Gloves (Non-sterile) K211360 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Pt. Universal Gloves. Cleared Jan 2022. https://www.510kdatabase.net/k212772/ 2022-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k212772-precision-align-fda-510k.jpg K212772 - Precision Align K212772 is a FDA 510(k) cleared dental medical device. Manufacturer: Precision Align, LLC. Cleared Jan 2022. https://www.510kdatabase.net/k201057/ 2022-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k201057-bio-medicus-life-support-catheter-and-fda-510k.jpg K201057 - Bio-Medicus Life Support Catheter and Introducer K201057 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k202783/ 2022-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k202783-renasys-f-xl-foam-dressing-kit-with-fda-510k.jpg K202783 - Renasys-F XL Foam Dressing Kit With Soft Port, Renasys XL Transparent Film Dressing K202783 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew Medical Limited. Cleared Jan 2022. https://www.510kdatabase.net/k203773/ 2022-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k203773-brm-tool-screws-fda-510k.jpg K203773 - BRM TOOL Screws K203773 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Brm Extremities Srl. Cleared Jan 2022. https://www.510kdatabase.net/k210466/ 2022-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k210466-silver-gelling-fiber-dressing-fda-510k.jpg K210466 - Silver Gelling Fiber Dressing K210466 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Winner Medical Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k210760/ 2022-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k210760-precise-image-fda-510k.jpg K210760 - Precise Image K210760 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Jan 2022. https://www.510kdatabase.net/k211254/ 2022-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k211254-arai-surgical-navigation-system-fda-510k.jpg K211254 - ARAI Surgical Navigation System K211254 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Surgalign Spine Technologies. Cleared Jan 2022. https://www.510kdatabase.net/k211632/ 2022-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k211632-pulse-oximeter-fro-200-fro-201-fro-202-fda-510k.jpg K211632 - Pulse Oximeter (FRO-200, FRO-201, FRO-202, FRO-203, FRO-204, FRO-100, FRO-101, FRO-102, FRO-103, FRO-104) K211632 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Narig Bio-Medical Technology Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k211814/ 2022-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k211814-wellead-endoscopic-seal-fda-510k.jpg K211814 - Wellead Endoscopic Seal K211814 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Well Lead Medical Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k212093/ 2022-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k212093-medline-universal-grounding-pad-fda-510k.jpg K212093 - Medline Universal Grounding Pad K212093 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medline Industries, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k212318/ 2022-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k212318-ipl-hair-removal-fda-510k.jpg K212318 - IPL Hair Removal K212318 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Dongguan Define Beauty Electronic Technology Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k212478/ 2022-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k212478-dermatological-diode-laser-system-fda-510k.jpg K212478 - Dermatological diode laser system K212478 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Beijing Stelle Laser Technology Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k212913/ 2022-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k212913-surgical-face-mask-fda-510k.jpg K212913 - Surgical Face Mask K212913 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangxi Ganlong Pharmaceutical Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k212997/ 2022-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k212997-surgical-mask-fda-510k.jpg K212997 - Surgical Mask K212997 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guangdong Zhizhen Biological Medical Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k213033/ 2022-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k213033-iassist-knee-system-fda-510k.jpg K213033 - iASSIST Knee System K213033 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthosoft D/B/A Zimmer Cas. Cleared Jan 2022. https://www.510kdatabase.net/k213307/ 2022-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k213307-eclipse-ii-with-smart-noise-cancellation-fda-510k.jpg K213307 - Eclipse II with Smart Noise Cancellation K213307 is a FDA 510(k) cleared radiology medical device. Manufacturer: Carestream Health, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k213335/ 2022-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k213335-capsule-surveillance-system-fda-510k.jpg K213335 - Capsule Surveillance System K213335 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Capsule Surveillance Technologies, Sas /Capsule Tech, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k213593/ 2022-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k213593-opticross-opticross-hd-opticross-6-fda-510k.jpg K213593 - OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD K213593 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Jan 2022. https://www.510kdatabase.net/k213602/ 2022-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k213602-argyle-peritoneal-dialysis-cathetor-fda-510k.jpg K213602 - Argyle Peritoneal Dialysis Cathetor and Kit, Ritus Peritoneal Dialysis Catheter Tunneling Tool Kit K213602 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Covidien, LLC. Cleared Jan 2022. https://www.510kdatabase.net/k213643/ 2022-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k213643-ultraprint-dental-temp-cb-uv-fda-510k.jpg K213643 - UltraPrint-Dental Temp C&B UV K213643 is a FDA 510(k) cleared dental medical device. Manufacturer: Guangzhou Heygears IMC., Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k213737/ 2022-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k213737-quantib-nd-fda-510k.jpg K213737 - Quantib ND K213737 is a FDA 510(k) cleared radiology medical device. Manufacturer: Quantib B.V.. Cleared Jan 2022. https://www.510kdatabase.net/k213833/ 2022-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k213833-scope-buddy-plus-endoscope-flushing-aid-fda-510k.jpg K213833 - SCOPE BUDDY PLUS Endoscope Flushing Aid K213833 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medivators, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k213927/ 2022-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k213927-respiratory-gating-for-scanners-v20-fda-510k.jpg K213927 - Respiratory Gating for Scanners v2.0 K213927 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k203706/ 2022-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k203706-dental-electric-motor-fda-510k.jpg K203706 - Dental Electric Motor K203706 is a FDA 510(k) cleared dental medical device. Manufacturer: Guilin Woodpecker Medical Instrument Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k211361/ 2022-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k211361-3n-contact-lenses-adjunct-cleaner-fda-510k.jpg K211361 - 3N Contact Lenses Adjunct Cleaner K211361 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Suzhou 3N Biological Technology Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k213642/ 2022-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k213642-voluson-s6-voluson-s8-voluson-s8t-fda-510k.jpg K213642 - Voluson S6, Voluson S8, Voluson S8t, Voluson S10, Voluson S10 Expert K213642 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Jan 2022. https://www.510kdatabase.net/k213859/ 2022-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k213859-stronghold-group-nitrile-examination-fda-510k.jpg K213859 - Stronghold Group Nitrile Examination Glove, Powder Free K213859 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Stronghold Group, LLC. Cleared Jan 2022. https://www.510kdatabase.net/k213895/ 2022-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k213895-distal-humerus-plating-system-fda-510k.jpg K213895 - Distal Humerus Plating System K213895 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Skeletal Dynamics, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k220097/ 2022-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k220097-president-the-original-fda-510k.jpg K220097 - PRESIDENT The Original K220097 is a FDA 510(k) cleared dental medical device. Manufacturer: Colt?ne/Whaledent AG. Cleared Jan 2022. https://www.510kdatabase.net/k212005/ 2022-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k212005-unid-spine-analyzer-fda-510k.jpg K212005 - UNiD Spine Analyzer K212005 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medicrea International, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k212569/ 2022-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k212569-materialise-shoulder-system-fda-510k.jpg K212569 - Materialise Shoulder System™, Materialise Shoulder Guide and Models, SurgiCase Shoulder Planner K212569 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Materialise NV. Cleared Jan 2022. https://www.510kdatabase.net/k212718/ 2022-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k212718-surgical-gowns-fda-510k.jpg K212718 - Surgical gowns K212718 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Xiantao Dingcheng Non-Woven Product Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k212877/ 2022-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k212877-arm-blood-pressure-monitor-fda-510k.jpg K212877 - Arm Blood Pressure Monitor K212877 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Alicn Medical (Shenzhen), Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k213095/ 2022-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k213095-andorate-suction-valve-andorate-fda-510k.jpg K213095 - andorate Suction Valve, andorate Air/Water Valve K213095 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ga Health Company Limited. Cleared Jan 2022. https://www.510kdatabase.net/k213308/ 2022-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k213308-venus-blissmax-fda-510k.jpg K213308 - Venus BlissMAX K213308 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Venus Concept USA, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k213915/ 2022-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k213915-bib-stent-placement-catheter-fda-510k.jpg K213915 - BIB Stent Placement Catheter K213915 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: NuMED, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k214012/ 2022-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k214012-straight-arm-ddr-fda-510k.jpg K214012 - Straight Arm DDR K214012 is a FDA 510(k) cleared radiology medical device. Manufacturer: Konica Minolta Healthcare Americas, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k191356/ 2022-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k191356-i3-foldable-mobility-scooter-fda-510k.jpg K191356 - i3 Foldable Mobility Scooter K191356 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Puc Perfect Union Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k202094/ 2022-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k202094-cardiovascular-suite-421-fda-510k.jpg K202094 - Cardiovascular Suite 4.2.1 K202094 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quipu S.R.L. Cleared Jan 2022. https://www.510kdatabase.net/k211851/ 2022-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k211851-ora-aid-fda-510k.jpg K211851 - Ora-Aid K211851 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Tbm Corporation. Cleared Jan 2022. https://www.510kdatabase.net/k212591/ 2022-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k212591-disposable-surgical-gown-fda-510k.jpg K212591 - Disposable Surgical Gown K212591 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Suzhou Janee Medical Technology Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k212735/ 2022-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k212735-nitrile-disposable-examination-gloves-fda-510k.jpg K212735 - Nitrile disposable examination gloves (Tested for use with Chemotherapy Drugs) K212735 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Xingyu Medical Tech Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k213102/ 2022-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k213102-es1-system-fda-510k.jpg K213102 - ES1 System K213102 is a FDA 510(k) cleared radiology medical device. Manufacturer: E-Scopics. Cleared Jan 2022. https://www.510kdatabase.net/k213168/ 2022-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k213168-medical-examination-gloves-fda-510k.jpg K213168 - Medical Examination Gloves K213168 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shandong Huiwosheng Health Technology Co.,Ltd. Cleared Jan 2022. https://www.510kdatabase.net/k213199/ 2022-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k213199-asnis-iii-cannulated-screw-system-and-fda-510k.jpg K213199 - Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System K213199 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker GmbH. Cleared Jan 2022. https://www.510kdatabase.net/k213380/ 2022-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k213380-360cas-fda-510k.jpg K213380 - 360CAS K213380 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Kico Knee Innovation Company Pty Limited. Cleared Jan 2022. https://www.510kdatabase.net/k213391/ 2022-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k213391-high-retention-attachment-system-fda-510k.jpg K213391 - High Retention Attachment System K213391 is a FDA 510(k) cleared dental medical device. Manufacturer: Zest Anchors, LLC. Cleared Jan 2022. https://www.510kdatabase.net/k213942/ 2022-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k213942-esteya-fda-510k.jpg K213942 - Esteya K213942 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nucletron B.V.. Cleared Jan 2022. https://www.510kdatabase.net/k211260/ 2022-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k211260-sheng-jing-tang-surgical-mask-fda-510k.jpg K211260 - Sheng Jing Tang Surgical Mask K211260 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Liaoning Shengjingtang Biotechnology Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k211274/ 2022-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k211274-iq-2-nasal-mask-phantom-2-nasal-mask-fda-510k.jpg K211274 - iQ 2 Nasal Mask, Phantom 2 Nasal Mask K211274 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sleepnet Corporation. Cleared Jan 2022. https://www.510kdatabase.net/k211419/ 2022-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k211419-gingi-aid-gel-fda-510k.jpg K211419 - Gingi-Aid Gel K211419 is a FDA 510(k) cleared dental medical device. Manufacturer: Belport Company, Inc., Gingi-Pak. Cleared Jan 2022. https://www.510kdatabase.net/k212358/ 2022-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k212358-romero-cervical-cage-fda-510k.jpg K212358 - Romero Cervical Cage K212358 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spineup, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k212505/ 2022-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k212505-dumi-manipulator-fda-510k.jpg K212505 - DUMI ManipulatOR K212505 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: The O R Company Pty, Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k212541/ 2022-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k212541-3delta-denture-base-3delta-denture-fda-510k.jpg K212541 - 3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix K212541 is a FDA 510(k) cleared dental medical device. Manufacturer: Deltamed GmbH. Cleared Jan 2022. https://www.510kdatabase.net/k212688/ 2022-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k212688-quantum-pureflow-standard-heat-fda-510k.jpg K212688 - Quantum PureFlow Standard Heat Exchanger, Quantum PureFlow Cardioplegia Heat Exchanger K212688 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Qura S.R.L. Cleared Jan 2022. https://www.510kdatabase.net/k212854/ 2022-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k212854-powered-wheelchair-fda-510k.jpg K212854 - Powered Wheelchair K212854 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zhejiang Qianxi Vehicle Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k212954/ 2022-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k212954-g-tech-wireless-patch-system-wps-fda-510k.jpg K212954 - G-Tech Wireless Patch System (WPS) K212954 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: G-Tech Medical. Cleared Jan 2022. https://www.510kdatabase.net/k213111/ 2022-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k213111-magnetos-granules-fda-510k.jpg K213111 - MagnetOs granules K213111 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Kuros Biosciences B.V. Cleared Jan 2022. https://www.510kdatabase.net/k211666/ 2022-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k211666-powder-free-nitrile-examination-gloves-fda-510k.jpg K211666 - Powder Free Nitrile Examination Gloves, Blue Chemotest K211666 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Careglove Global Sdn. Bhd.. Cleared Jan 2022. https://www.510kdatabase.net/k212801/ 2022-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k212801-powder-free-nitrile-examination-glove-fda-510k.jpg K212801 - Powder free nitrile examination glove- black, non sterile K212801 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hong Seng Gloves Sdn Bhd. Cleared Jan 2022. https://www.510kdatabase.net/k203360/ 2022-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k203360-ek-implants-and-abutments-system-fda-510k.jpg K203360 - EK Implants and Abutments System K203360 is a FDA 510(k) cleared dental medical device. Manufacturer: Hiossen, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k210039/ 2022-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k210039-core1-implant-system-fda-510k.jpg K210039 - CORE1 Implant System K210039 is a FDA 510(k) cleared dental medical device. Manufacturer: Cybermed, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k210198/ 2022-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k210198-gpc-24mm-variable-angle-locking-twon-fda-510k.jpg K210198 - GPC 2.4mm Variable Angle Locking Twon Column Volar Distal Radius Plates, 6 head Holes, GPC 2.4mm Variable Angle Locking Two Column Volar Distal Radius Plates, 7 Head Holes, 2.4 mm Variable Angle Locking Two Column Volar Distal Radius Plate-Narrow, 6 Head Holes, Variable Angle Locking Screw 2.4 mm, Stardrive K210198 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Gpc Medical Limited. Cleared Jan 2022. https://www.510kdatabase.net/k210564/ 2022-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k210564-infrared-thermometer-fda-510k.jpg K210564 - Infrared Thermometer K210564 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Alicn Medical (Shenzhen), Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k211110/ 2022-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k211110-agile-devices-angler-steerable-fda-510k.jpg K211110 - Agile Devices Angler Steerable, Deflectable Microcatheter K211110 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Agile Devices, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k211269/ 2022-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k211269-visualase-mri-guided-laser-ablation-fda-510k.jpg K211269 - Visualase MRI-Guided Laser Ablation System (SW 3.4) K211269 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Navigation, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k211349/ 2022-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k211349-selebrek-ptca-balloon-dilatation-fda-510k.jpg K211349 - Selebrek PTCA Balloon Dilatation Catheter K211349 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Kossel Medtech (Suzhou) Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k211443/ 2022-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k211443-aibolit-3d-fda-510k.jpg K211443 - AIBOLIT 3D+ K211443 is a FDA 510(k) cleared radiology medical device. Manufacturer: Aibolit Technologies, LLC. Cleared Jan 2022. https://www.510kdatabase.net/k211716/ 2022-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k211716-dropsafe-safety-pen-needles-fda-510k.jpg K211716 - DropSafe Safety Pen Needles K211716 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Htl Strefa SA. Cleared Jan 2022. https://www.510kdatabase.net/k211742/ 2022-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k211742-signasure-dual-mobility-system-fda-510k.jpg K211742 - SignaSure Dual Mobility System K211742 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Signature Orthopaedics Pty, Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k211940/ 2022-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k211940-fetal-doppler-fda-510k.jpg K211940 - Fetal Doppler K211940 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shenzhen Taikang Medical Equipment Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k212127/ 2022-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k212127-picocaremajesty-fda-510k.jpg K212127 - Picocaremajesty K212127 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wontech Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k212152/ 2022-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k212152-prelude-ideal-9f-hydrophilic-sheath-fda-510k.jpg K212152 - Prelude IDeal 9F Hydrophilic Sheath Introducer K212152 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems. Cleared Jan 2022. https://www.510kdatabase.net/k212166/ 2022-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k212166-isis-headboxes-isis-neurostimulator-fda-510k.jpg K212166 - ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress K212166 is a FDA 510(k) cleared neurology medical device. Manufacturer: Inomed Medizintechnik GmbH. Cleared Jan 2022. https://www.510kdatabase.net/k212841/ 2022-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k212841-pectus-blu-support-bar-system-fda-510k.jpg K212841 - Pectus Blu Support Bar System K212841 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet Micofixation. Cleared Jan 2022. https://www.510kdatabase.net/k212980/ 2022-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k212980-tesera-k-alif-system-fda-510k.jpg K212980 - Tesera-k ALIF System K212980 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Kyocera Medical Technologies, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k212990/ 2022-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k212990-acumed-ankle-syndesmosis-repair-system-fda-510k.jpg K212990 - Acumed Ankle Syndesmosis Repair System K212990 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Acumed, LLC. Cleared Jan 2022. https://www.510kdatabase.net/k213262/ 2022-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k213262-celerity-hp-chemical-indicator-fda-510k.jpg K213262 - CELERITY HP Chemical Indicator K213262 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Jan 2022. https://www.510kdatabase.net/k213570/ 2022-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k213570-dental-zirconia-ceramic-fda-510k.jpg K213570 - Dental Zirconia Ceramic K213570 is a FDA 510(k) cleared dental medical device. Manufacturer: Aidite (Qinhuangdao) Technology Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k213720/ 2022-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k213720-vital-navigation-system-fda-510k.jpg K213720 - Vital Navigation System K213720 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimvie (Zimmer Biomet Spine, Inc.). Cleared Jan 2022. https://www.510kdatabase.net/k213880/ 2022-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k213880-custom-stable-rigid-gas-permeable-fda-510k.jpg K213880 - Custom Stable Rigid Gas Permeable Scleral Contact Lens K213880 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Valley Contax, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k213901/ 2022-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k213901-cyclops-anterior-cervical-plate-system-fda-510k.jpg K213901 - Cyclops™ Anterior Cervical Plate System K213901 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Degen Medical. Cleared Jan 2022. https://www.510kdatabase.net/den210015/ 2022-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/den210015-sunrise-sleep-disorder-diagnostic-aid-fda-510k.jpg DEN210015 - Sunrise Sleep Disorder Diagnostic Aid DEN210015 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sunrise. Cleared Jan 2022. https://www.510kdatabase.net/k211135/ 2022-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k211135-enlight-2100-fda-510k.jpg K211135 - Enlight 2100 K211135 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Timpel S.A.. Cleared Jan 2022. https://www.510kdatabase.net/k211499/ 2022-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k211499-23andme-pgs-genetic-risk-report-for-fda-510k.jpg K211499 - 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related) K211499 is a FDA 510(k) cleared medical genetics medical device. Manufacturer: 23AndMe, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k212468/ 2022-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k212468-tigereye-cto-crossing-catheter-fda-510k.jpg K212468 - Tigereye CTO-Crossing Catheter K212468 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Avinger, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k212797/ 2022-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k212797-iprime-viscodelivery-system-fda-510k.jpg K212797 - iPrime Viscodelivery System K212797 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Glaukos. Cleared Jan 2022. https://www.510kdatabase.net/k212847/ 2022-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k212847-penta-glove-fda-510k.jpg K212847 - Penta Glove K212847 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Pentavest Holdings Sdn Bhd. Cleared Jan 2022. https://www.510kdatabase.net/k213053/ 2022-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k213053-gold-anchor-fda-510k.jpg K213053 - Gold Anchor K213053 is a FDA 510(k) cleared radiology medical device. Manufacturer: Naslund Medical AB. Cleared Jan 2022. https://www.510kdatabase.net/k213544/ 2022-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k213544-tomtec-arena-fda-510k.jpg K213544 - TOMTEC-ARENA K213544 is a FDA 510(k) cleared radiology medical device. Manufacturer: Tomtec Imaging Systems GmbH. Cleared Jan 2022. https://www.510kdatabase.net/k213546/ 2022-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k213546-exactechgps-total-shoulder-application-fda-510k.jpg K213546 - ExactechGPS Total Shoulder Application, Equinoxe Planning Software K213546 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Blue Ortho. Cleared Jan 2022. https://www.510kdatabase.net/k213839/ 2022-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k213839-depuy-corail-amt-hip-prosthesis-fda-510k.jpg K213839 - DePuy Corail AMT Hip Prosthesis K213839 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k213841/ 2022-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k213841-eneo-totale-model-eneot947-fda-510k.jpg K213841 - ENEO TOTALE (Model: ENEOT947) K213841 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Premier North America, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k211149/ 2022-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k211149-urethral-warming-catheter-kit-fda-510k.jpg K211149 - Urethral Warming Catheter Kit K211149 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k211318/ 2022-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k211318-pico-7-single-use-negative-pressure-fda-510k.jpg K211318 - PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Packs K211318 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew Medical Limited. Cleared Jan 2022. https://www.510kdatabase.net/k211978/ 2022-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k211978-jplant-fda-510k.jpg K211978 - Jplant K211978 is a FDA 510(k) cleared dental medical device. Manufacturer: Jj Medical Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k212115/ 2022-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k212115-arm-type-fully-automatic-digital-blood-fda-510k.jpg K212115 - Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor K212115 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Joytech Healthcare Co. , Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k212609/ 2022-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k212609-bha100-series-braun-clear-hearing-aid-fda-510k.jpg K212609 - BHA100 Series Braun Clear Hearing Aid K212609 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Kaz USA, Inc., A Helen of Troy Company. Cleared Jan 2022. https://www.510kdatabase.net/k213019/ 2022-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k213019-vinyl-exam-gloves-fda-510k.jpg K213019 - Vinyl Exam Gloves K213019 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hebei Astro Medical Supply Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k213281/ 2022-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k213281-pass-lp-spinal-system-cd-horizon-fda-510k.jpg K213281 - PASS LP™ Spinal System, CD Horizon™ Spinal System K213281 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medicrea International SA. Cleared Jan 2022. https://www.510kdatabase.net/k213342/ 2022-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k213342-pro-dense-lovisc-bone-graft-substitute-fda-510k.jpg K213342 - PRO-DENSE LoVisc Bone Graft Substitute K213342 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jan 2022. https://www.510kdatabase.net/k213344/ 2022-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k213344-btl-899a-fda-510k.jpg K213344 - BTL-899A K213344 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: BTL Industries, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k213816/ 2022-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k213816-mpo-hip-instruments-fda-510k.jpg K213816 - MPO Hip Instruments K213816 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Microport Orthopedics, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k213817/ 2022-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k213817-mpo-knee-instruments-fda-510k.jpg K213817 - MPO Knee Instruments K213817 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Microport Orthopedics, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k213879/ 2022-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k213879-self-adhesive-electrode-fda-510k.jpg K213879 - Self-adhesive Electrode K213879 is a FDA 510(k) cleared neurology medical device. Manufacturer: Bozhou Rongjian Medical Appliance Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k213951/ 2022-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k213951-forza-xp-expandable-spacer-system-fda-510k.jpg K213951 - FORZA XP Expandable Spacer System K213951 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthofix US, LLC. Cleared Jan 2022. https://www.510kdatabase.net/k202994/ 2022-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k202994-innoclip-disposable-clip-applier-fda-510k.jpg K202994 - InnoClip Disposable Clip Applier, InnoClip Clip Applier K202994 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Taiwan Surgical Corporation. Cleared Jan 2022. https://www.510kdatabase.net/k203595/ 2022-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k203595-dynafuse-fixation-system-fda-510k.jpg K203595 - DynaFuse Fixation System K203595 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: MedShape, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k211647/ 2022-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k211647-hp358ea-electrically-powered-wheelchair-fda-510k.jpg K211647 - HP358EA Electrically Powered Wheelchair K211647 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Kunshan Hi-Fortune Health Products Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k211789/ 2022-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k211789-restor3d-pin-implants-fda-510k.jpg K211789 - restor3d Pin Implants K211789 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Restor3d. Cleared Jan 2022. https://www.510kdatabase.net/k212299/ 2022-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k212299-medical-surgical-mask-fda-510k.jpg K212299 - Medical Surgical Mask K212299 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wepon Medical Technology Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k212375/ 2022-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k212375-disposable-medical-surgical-mask-fda-510k.jpg K212375 - Disposable Medical Surgical Mask K212375 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangxi Bestgrand Health Technology Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k213080/ 2022-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k213080-t-edge-10-t-edge-11-fda-510k.jpg K213080 - T-Edge 10, T-Edge 11 K213080 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Tuttnauer , Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k213831/ 2022-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k213831-olympus-pk-electrosurgical-instruments-fda-510k.jpg K213831 - Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle K213831 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Gyrus Acmi, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k210830/ 2022-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k210830-vuze-system-fda-510k.jpg K210830 - VUZE System K210830 is a FDA 510(k) cleared radiology medical device. Manufacturer: Vuze Medical , Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k213068/ 2022-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k213068-medline-smoke-evacuation-shroud-fda-510k.jpg K213068 - Medline Smoke Evacuation Shroud K213068 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k213187/ 2022-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k213187-disposable-nitrile-medical-powder-free-fda-510k.jpg K213187 - Disposable Nitrile Medical Powder-free Glove K213187 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Fujian Chunhui Medical Supply Co., Ltd.. Cleared Jan 2022. https://www.510kdatabase.net/k203177/ 2022-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k203177-sterisystem-dry-base-instrument-tray-fda-510k.jpg K203177 - Sterisystem Dry-Base Instrument Tray K203177 is a FDA 510(k) cleared general hospital medical device. Manufacturer: O&M Halyard, Inc.. Cleared Jan 2022. https://www.510kdatabase.net/k202898/ 2021-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k202898-tzoar-207-negative-pressure-wound-fda-510k.jpg K202898 - Tzoar 207 Negative Pressure Wound Therapy (NPWT) System K202898 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lightstone Medical Products (Ningbo) Co, Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k211159/ 2021-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k211159-eco-x-series-eco-x-eco-x-s-fda-510k.jpg K211159 - eco-x Series (eco-x, eco-x-s) K211159 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hdx Will Corp.. Cleared Dec 2021. https://www.510kdatabase.net/k211263/ 2021-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k211263-intrelief-fda-510k.jpg K211263 - Intrelief K211263 is a FDA 510(k) cleared neurology medical device. Manufacturer: Easymed Instruments Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k211458/ 2021-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k211458-disposable-anorectal-staplers-fda-510k.jpg K211458 - Disposable Anorectal Staplers, Disposable Intraluminal Staplers, Disposable Linear Cutting Staplers, Disposable Endoscopic Cutting Staplers K211458 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ningbo Verykind Medical Device Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k212547/ 2021-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k212547-quick-start-screws-fda-510k.jpg K212547 - Quick-Start Screws K212547 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Innovate Orthopaedics Limited. Cleared Dec 2021. https://www.510kdatabase.net/k212834/ 2021-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k212834-disposable-nitrile-medical-examination-fda-510k.jpg K212834 - Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs) K212834 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Siyang Threeguard Medical Supplies Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k213538/ 2021-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k213538-acuity-200-with-tangible-hydra-peg-fda-510k.jpg K213538 - Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens K213538 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Acuity Polymers, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k202101/ 2021-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k202101-gem-hemochron-100-system-gem-hemochron-fda-510k.jpg K202101 - GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), directCHECK ACT+ Whole Blood Control, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Control, Level 1 and Level 2 K202101 is a FDA 510(k) cleared hematology medical device. Manufacturer: Accriva Diagnostics, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k211156/ 2021-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k211156-convivo-in-vivo-pathology-suite-fda-510k.jpg K211156 - CONVIVO In Vivo Pathology Suite K211156 is a FDA 510(k) cleared neurology medical device. Manufacturer: Carl Zeiss Meditec, AG. Cleared Dec 2021. https://www.510kdatabase.net/k212656/ 2021-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k212656-flexible-intubation-video-endoscope-fda-510k.jpg K212656 - Flexible Intubation Video Endoscope – Sterile (FIVE-S) K212656 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Karl Storz Endoscopy America. Cleared Dec 2021. https://www.510kdatabase.net/k213073/ 2021-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k213073-goody-gloves-wincare-tbg-gloves-fda-510k.jpg K213073 - Goody Gloves, Wincare, TBG Gloves K213073 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Thai Rubber Gloves Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k213316/ 2021-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k213316-life-scope-pt-bsm-1700-series-ay-fda-510k.jpg K213316 - Life Scope PT BSM-1700 Series, AY Series, Data Acquisition Unit, LIFE SCOPE BSM 6000 SERIES BEDSIDE MONITORING SYSTEM, Nihon Kohden CSM-1901 BEDSIDE MONITORING SYSTEM K213316 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Nihon Kohden Corporation. Cleared Dec 2021. https://www.510kdatabase.net/k213776/ 2021-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k213776-liversmart-fda-510k.jpg K213776 - LiverSmart K213776 is a FDA 510(k) cleared radiology medical device. Manufacturer: Resonance Health Analysis Services Pty, Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k212806/ 2021-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k212806-alcon-serafilcon-a-soft-contact-lenses-fda-510k.jpg K212806 - Alcon (serafilcon A) soft contact lenses for daily wear K212806 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Alcon Laboratories, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k213016/ 2021-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k213016-atm-glove-fda-510k.jpg K213016 - ATM Glove K213016 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Phu Duc Huy Production Trading Services Corporation. Cleared Dec 2021. https://www.510kdatabase.net/k213209/ 2021-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k213209-ez-trax-zimmer-g7-acetabular-system-fda-510k.jpg K213209 - EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment Device K213209 is a FDA 510(k) cleared general hospital medical device. Manufacturer: K1 Medical, LLC. Cleared Dec 2021. https://www.510kdatabase.net/k193138/ 2021-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k193138-colibri-system-fda-510k.jpg K193138 - Colibri System K193138 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Copan Wasp Srl. Cleared Dec 2021. https://www.510kdatabase.net/k212716/ 2021-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k212716-dermoaroma-disposable-nitrile-fda-510k.jpg K212716 - Dermoaroma Disposable Nitrile Examination Glove K212716 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Chuzhou Harmony Gloves Medical Technology Co.,Ltd. Cleared Dec 2021. https://www.510kdatabase.net/k212848/ 2021-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k212848-sterile-latex-surgical-gloves-powder-fda-510k.jpg K212848 - Sterile Latex Surgical Gloves Powder Free K212848 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Pentavest Holdings Sdn Bhd. Cleared Dec 2021. https://www.510kdatabase.net/k213763/ 2021-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k213763-sonosite-px-ultrasound-system-fda-510k.jpg K213763 - Sonosite PX Ultrasound System K213763 is a FDA 510(k) cleared radiology medical device. Manufacturer: FUJIFILM Sonosite, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k203523/ 2021-12-25 monthly 0.5 https://www.510kdatabase.net/og-image/k203523-fixone-hybrid-knotless-anchor-fda-510k.jpg K203523 - Fixone hybrid knotless anchor K203523 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aju Pharm Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k211770/ 2021-12-25 monthly 0.5 https://www.510kdatabase.net/og-image/k211770-r3act-stabilization-system-fda-510k.jpg K211770 - R3ACT Stabilization System K211770 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paragon 28, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k202255/ 2021-12-24 monthly 0.5 https://www.510kdatabase.net/og-image/k202255-skypro-sp02-mask-3-fda-510k.jpg K202255 - Skypro, SP02 Mask (3) K202255 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Skypro Medical Supplies Company. Cleared Dec 2021. https://www.510kdatabase.net/k212921/ 2021-12-24 monthly 0.5 https://www.510kdatabase.net/og-image/k212921-nitrile-examination-golves-powder-free-fda-510k.jpg K212921 - Nitrile Examination Golves Powder Free K212921 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Standard Health Co.,Ltd. Cleared Dec 2021. https://www.510kdatabase.net/k213136/ 2021-12-24 monthly 0.5 https://www.510kdatabase.net/og-image/k213136-cpl-surgical-face-mask-fda-510k.jpg K213136 - CPL Surgical Face Mask K213136 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Control Print Limited. Cleared Dec 2021. https://www.510kdatabase.net/k193407/ 2021-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k193407-contour-next-gen-blood-glucose-fda-510k.jpg K193407 - Contour® next GEN Blood Glucose Monitoring System K193407 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Ascensia Diabetes Care. Cleared Dec 2021. https://www.510kdatabase.net/k202788/ 2021-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k202788-sonomed-iv-sonomed-v-fda-510k.jpg K202788 - Sonomed IV, Sonomed V K202788 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Carci Industria E Comercio DE Aparelhos Cirurgicos E Orto. Cleared Dec 2021. https://www.510kdatabase.net/k203714/ 2021-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k203714-nuvasive-thoracolumbar-interbody-fda-510k.jpg K203714 - NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVasive Cohere Thoracolumbar Interbody System, NuVasive Modulus XLIF Interbody System, NuVasive Modulus TLIF Interbody System, NuVasive Modulus ALIF System, NuVasive Attrax Putty K203714 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Dec 2021. https://www.510kdatabase.net/k210976/ 2021-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k210976-curian-campy-fda-510k.jpg K210976 - Curian Campy K210976 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Meridian Bioscience, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k210992/ 2021-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k210992-altech-exhalation-valve-single-limb-fda-510k.jpg K210992 - Altech® Exhalation Valve (Single Limb and Dual Limb) K210992 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Meditera Tibbi Malzeme San VE Tic AS. Cleared Dec 2021. https://www.510kdatabase.net/k212088/ 2021-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k212088-integrity-implants-navigated-instruments-fda-510k.jpg K212088 - Integrity Implants Navigated Instruments K212088 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Integrity Implants, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k212436/ 2021-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k212436-nbr-synthetic-nitrile-examination-gloves-fda-510k.jpg K212436 - NBR Synthetic Nitrile Examination Gloves K212436 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shandong Langtai International Trade Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k213208/ 2021-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k213208-twist-drills-fda-510k.jpg K213208 - Twist Drills K213208 is a FDA 510(k) cleared neurology medical device. Manufacturer: Biomet Microfixation. Cleared Dec 2021. https://www.510kdatabase.net/k213219/ 2021-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k213219-vy-spine-vywasher-buttress-system-fda-510k.jpg K213219 - Vy Spine™ VyWasher™ Buttress System K213219 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Vy Spine, LLC. Cleared Dec 2021. https://www.510kdatabase.net/k213479/ 2021-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k213479-drs-and-drs-9090-fda-510k.jpg K213479 - D²RS and D²RS 9090 K213479 is a FDA 510(k) cleared radiology medical device. Manufacturer: Stephanix. Cleared Dec 2021. https://www.510kdatabase.net/k213547/ 2021-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k213547-skore-smooth-condoms-skore-colors-fda-510k.jpg K213547 - SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla K213547 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ttk Healthcare Limited. Cleared Dec 2021. https://www.510kdatabase.net/k213766/ 2021-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k213766-ds-footankle-16ch-coils-for-15t-and-fda-510k.jpg K213766 - dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small Extremity 16Ch Coils for 1.5T and 3.0T K213766 is a FDA 510(k) cleared radiology medical device. Manufacturer: Invivo Corporation. Cleared Dec 2021. https://www.510kdatabase.net/k202404/ 2021-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k202404-bonemri-fda-510k.jpg K202404 - BoneMRI K202404 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mriguidance B.V.. Cleared Dec 2021. https://www.510kdatabase.net/k203564/ 2021-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k203564-sefria-oxycodone-oral-fluid-enzyme-fda-510k.jpg K203564 - SEFRIA Oxycodone Oral Fluid Enzyme Immunoassay K203564 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Immunalysis Corporation. Cleared Dec 2021. https://www.510kdatabase.net/k203647/ 2021-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k203647-sefria-methamphetamine-oral-fluid-fda-510k.jpg K203647 - SEFRIA Methamphetamine Oral Fluid Enzyme Immunoassay K203647 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Immunalysis Corporation. Cleared Dec 2021. https://www.510kdatabase.net/k210147/ 2021-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k210147-unico-high-performance-surgical-mask-fda-510k.jpg K210147 - Unico High Performance Surgical Mask, Unico High Performance Surgical Mask with Face Shield K210147 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Unicoglobal, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k210305/ 2021-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k210305-pulse-oximeter-fda-510k.jpg K210305 - Pulse Oximeter K210305 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Dongguan Lingxin Technologies Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k210711/ 2021-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k210711-neocis-guidance-system-ngs-with-yomi-fda-510k.jpg K210711 - Neocis Guidance System (NGS) with Yomi Plan v2.0.1 K210711 is a FDA 510(k) cleared dental medical device. Manufacturer: Neocis, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k210978/ 2021-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k210978-bd-quincke-spinal-needle-bd-whitacre-fda-510k.jpg K210978 - BD Quincke Spinal Needle, BD Whitacre Spinal Needle, BD Spinal Introducer Needle K210978 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Becton, Dickinson and Company. Cleared Dec 2021. https://www.510kdatabase.net/k211022/ 2021-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k211022-blue-non-sterile-powder-free-nitrile-fda-510k.jpg K211022 - Blue Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims. K211022 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Central Medicare Sdn Bhd. Cleared Dec 2021. https://www.510kdatabase.net/k211691/ 2021-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k211691-ultrast-gel-fda-510k.jpg K211691 - Ultrast Gel K211691 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ultrast, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k212285/ 2021-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k212285-electrical-neuromuscular-stimulator-fda-510k.jpg K212285 - Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android) K212285 is a FDA 510(k) cleared neurology medical device. Manufacturer: Oriental Inspiration Limited. Cleared Dec 2021. https://www.510kdatabase.net/k212310/ 2021-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k212310-eyebox-model-ebx-4-fda-510k.jpg K212310 - EyeBOX (Model EBX-4) K212310 is a FDA 510(k) cleared neurology medical device. Manufacturer: Oculogica, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k212397/ 2021-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k212397-stealthstation-s8-cranial-v20-fda-510k.jpg K212397 - StealthStation S8 Cranial v2.0 K212397 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Navigation. Cleared Dec 2021. https://www.510kdatabase.net/k212603/ 2021-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k212603-non-absorbable-surgical-nylon-suture-fda-510k.jpg K212603 - Non Absorbable Surgical Nylon Suture K212603 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shandong Haidike Medical Product Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k212767/ 2021-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k212767-sleepright-select-comfort-dental-guard-fda-510k.jpg K212767 - SleepRight Select-Comfort Dental Guard K212767 is a FDA 510(k) cleared dental medical device. Manufacturer: Splintek, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k212914/ 2021-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k212914-glovmaster-nitrile-examination-glove-fda-510k.jpg K212914 - Glovmaster Nitrile Examination Glove Powder Free K212914 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Glovmaster Sdn. Bhd.. Cleared Dec 2021. https://www.510kdatabase.net/k213024/ 2021-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k213024-oren-led-perioral-light-therapy-system-fda-510k.jpg K213024 - Oren LED Perioral Light Therapy System K213024 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Kaiyan Medical CO , Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k213094/ 2021-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k213094-id-500-irestore-hair-growth-system-fda-510k.jpg K213094 - ID-500 iRestore Hair Growth System K213094 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Freedom Laser Therapy, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k213140/ 2021-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k213140-claritas-ipet-fda-510k.jpg K213140 - Claritas iPET K213140 is a FDA 510(k) cleared radiology medical device. Manufacturer: Claritas Healthtech Pte, Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k213144/ 2021-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k213144-biodegradable-powder-free-vinyl-fda-510k.jpg K213144 - Biodegradable Powder Free Vinyl Examination Gloves Blue, Green and White Colors K213144 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shen Wei (Usa), Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k213159/ 2021-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k213159-encore-system-fda-510k.jpg K213159 - Encore System K213159 is a FDA 510(k) cleared dental medical device. Manufacturer: Siesta Medical, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k213207/ 2021-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k213207-sheath-stopcock-accessory-fda-510k.jpg K213207 - Sheath, Stopcock Accessory K213207 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Olympus Winter & Ibe GmbH. Cleared Dec 2021. https://www.510kdatabase.net/k213225/ 2021-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k213225-diode-laser-system-gp900a8-diode-laser-fda-510k.jpg K213225 - Diode Laser System GP900A8, Diode Laser System GP900Q8 K213225 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Gsd Tech Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k213411/ 2021-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k213411-isrobot-mona-lisa-20-fda-510k.jpg K213411 - iSR’obot Mona Lisa 2.0 K213411 is a FDA 510(k) cleared radiology medical device. Manufacturer: Biobot Surgical Pte., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k213428/ 2021-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k213428-edgepro-fda-510k.jpg K213428 - EdgePro K213428 is a FDA 510(k) cleared dental medical device. Manufacturer: Biolase, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k213691/ 2021-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k213691-solas-or-fda-510k.jpg K213691 - Solas OR K213691 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cirdan Imaging, Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k203343/ 2021-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k203343-wesper-lab-fda-510k.jpg K203343 - Wesper Lab K203343 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Wesper, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k203660/ 2021-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k203660-tri-matrix-implant-line-fda-510k.jpg K203660 - TRI-matrix Implant Line K203660 is a FDA 510(k) cleared dental medical device. Manufacturer: Tri Dental Implants Int. AG. Cleared Dec 2021. https://www.510kdatabase.net/k210099/ 2021-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k210099-meticuly-patient-specific-titanium-fda-510k.jpg K210099 - Meticuly Patient-Specific Titanium Mesh Implant K210099 is a FDA 510(k) cleared neurology medical device. Manufacturer: Meticuly Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k210331/ 2021-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k210331-cardiamend-pericardial-and-epicardial-fda-510k.jpg K210331 - CardiaMend Pericardial and Epicardial Reconstruction Matrix K210331 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Helios Cardio, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k210670/ 2021-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k210670-bu-cad-fda-510k.jpg K210670 - BU-CAD K210670 is a FDA 510(k) cleared radiology medical device. Manufacturer: Taihao Medical, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k210968/ 2021-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k210968-revive-light-therapy-essentials-fda-510k.jpg K210968 - reVive Light Therapy Essentials K210968 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Led Technologies, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k211078/ 2021-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k211078-progreat-lambda-fda-510k.jpg K211078 - Progreat Lambda K211078 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Clinical Supply Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k211086/ 2021-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k211086-the-progen-trochanteric-nail-system-fda-510k.jpg K211086 - The Progen™ Trochanteric Nail System K211086 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ortho Development Corporation. Cleared Dec 2021. https://www.510kdatabase.net/k211109/ 2021-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k211109-n1-tiultra-tcc-implant-system-fda-510k.jpg K211109 - N1 TiUltra TCC Implant System K211109 is a FDA 510(k) cleared dental medical device. Manufacturer: Nobel Biocare Services AG. Cleared Dec 2021. https://www.510kdatabase.net/k211918/ 2021-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k211918-icoquit-smokerlyzer-fda-510k.jpg K211918 - iCOquit® Smokerlyzer® K211918 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bedfont Scientific, Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k212155/ 2021-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k212155-theraface-led-fda-510k.jpg K212155 - TheraFace LED K212155 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Theragun, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k212266/ 2021-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k212266-fix-c-peek-anterior-cervical-interbody-fda-510k.jpg K212266 - FIX-C PEEK Anterior Cervical Interbody System K212266 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Jeil Medical Corporation. Cleared Dec 2021. https://www.510kdatabase.net/k212613/ 2021-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k212613-powder-free-nitrile-examination-gloves-fda-510k.jpg K212613 - Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue) K212613 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Koon Seng Sdn Bhd. Cleared Dec 2021. https://www.510kdatabase.net/k212690/ 2021-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k212690-qxr-bt-fda-510k.jpg K212690 - qXR-BT K212690 is a FDA 510(k) cleared radiology medical device. Manufacturer: Qure.Ai Technologies. Cleared Dec 2021. https://www.510kdatabase.net/k212730/ 2021-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k212730-bellatek-encode-emergence-healing-fda-510k.jpg K212730 - BellaTek Encode Emergence Healing Abutments K212730 is a FDA 510(k) cleared dental medical device. Manufacturer: Biomet 3i, LLC. Cleared Dec 2021. https://www.510kdatabase.net/k212770/ 2021-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k212770-vision-fda-510k.jpg K212770 - Vision K212770 is a FDA 510(k) cleared dental medical device. Manufacturer: Softsmile, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k212830/ 2021-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k212830-ct3000pro-fda-510k.jpg K212830 - CT3000Pro K212830 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Srs Medical. Cleared Dec 2021. https://www.510kdatabase.net/k213006/ 2021-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k213006-vinyl-examination-gloves-fda-510k.jpg K213006 - Vinyl Examination Gloves K213006 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Taian Hengchang Medical Technology Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k213045/ 2021-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k213045-tearcare-system-fda-510k.jpg K213045 - TearCare System K213045 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Sight Sciences, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k213129/ 2021-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k213129-restoration-modular-115mm-conical-fda-510k.jpg K213129 - Restoration Modular 115mm Conical Distal Stem K213129 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp., Dba Stryker Orthopaedics. Cleared Dec 2021. https://www.510kdatabase.net/k213139/ 2021-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k213139-surgmatic-s15-l-pro-fda-510k.jpg K213139 - SURGmatic S15 L Pro K213139 is a FDA 510(k) cleared dental medical device. Manufacturer: Kavo Dental GmbH. Cleared Dec 2021. https://www.510kdatabase.net/k213301/ 2021-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k213301-incore-subtalar-system-fda-510k.jpg K213301 - InCore Subtalar System K213301 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nextremity Solutions, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k213456/ 2021-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k213456-xenco-medical-multilevel-cervikit-fda-510k.jpg K213456 - Xenco Medical Multilevel CerviKit K213456 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Xenco Medical, LLC. Cleared Dec 2021. https://www.510kdatabase.net/k213596/ 2021-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k213596-ossiofiber-compression-screw-35mm-fda-510k.jpg K213596 - OSSIOfiber Compression Screw, 3.5mm K213596 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OSSIO , Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k213705/ 2021-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k213705-drsplus-fda-510k.jpg K213705 - DRSplus K213705 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Centervue S.P.A.. Cleared Dec 2021. https://www.510kdatabase.net/den210024/ 2021-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/den210024-cavaclear-laser-sheath-fda-510k.jpg DEN210024 - CavaClear Laser Sheath DEN210024 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Spectranetics, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k202568/ 2021-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k202568-mpact-3d-metal-implants-dmls-technology-fda-510k.jpg K202568 - Mpact® 3D Metal Implants - DMLS Technology K202568 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Dec 2021. https://www.510kdatabase.net/k203468/ 2021-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k203468-tcat-tka-instrument-tray-fda-510k.jpg K203468 - TCAT TKA Instrument Tray K203468 is a FDA 510(k) cleared general hospital medical device. Manufacturer: THINK Surgical, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k203741/ 2021-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k203741-sensititre-18-24-hour-mic-or-fda-510k.jpg K203741 - Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 ug/ml K203741 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Thermo Fisher Scientific. Cleared Dec 2021. https://www.510kdatabase.net/k211185/ 2021-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k211185-ipl-home-use-hair-removal-device-fda-510k.jpg K211185 - IPL Home Use Hair Removal Device K211185 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k211521/ 2021-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k211521-3m-veraflo-cleanse-choice-complete-fda-510k.jpg K211521 - 3M Veraflo Cleanse Choice Complete Dressing Kit (Medium Dressing Kit: VFCCC05MD, Large Dressing Kit: VFCCC05LG) K211521 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3M Healthcare Business Group. Cleared Dec 2021. https://www.510kdatabase.net/k211750/ 2021-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k211750-disposable-surgical-face-mask-fda-510k.jpg K211750 - Disposable Surgical Face Mask, Disposable Surgical Face Mask (Sterile) K211750 is a FDA 510(k) cleared general hospital medical device. Manufacturer: National Bridge Industrial (S.Z.) Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k211842/ 2021-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k211842-servator-m-salf-solution-fda-510k.jpg K211842 - Servator M SALF Solution K211842 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: S.A.L.F. Spa. Cleared Dec 2021. https://www.510kdatabase.net/k211847/ 2021-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k211847-advance-xp-male-sling-system-fda-510k.jpg K211847 - AdVance XP Male Sling System K211847 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Dec 2021. https://www.510kdatabase.net/k211865/ 2021-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k211865-powder-free-vinyl-patient-examination-fda-510k.jpg K211865 - Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) K211865 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Liao Ning Shangwei Medical Products Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k212492/ 2021-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k212492-frax-1940-for-nordlys-and-frax-pro-fda-510k.jpg K212492 - Frax 1940 for Nordlys and Frax Pro K212492 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Candela Corporation. Cleared Dec 2021. https://www.510kdatabase.net/k212715/ 2021-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k212715-vy-spine-clarivy-cervical-ibf-system-fda-510k.jpg K212715 - Vy Spine ClariVy Cervical IBF System K212715 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Vy Spine, LLC. Cleared Dec 2021. https://www.510kdatabase.net/k212776/ 2021-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k212776-reprocessed-advisor-hd-grid-mapping-fda-510k.jpg K212776 - Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled K212776 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Innovative Health, LLC. Cleared Dec 2021. https://www.510kdatabase.net/k212859/ 2021-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k212859-first-relief-fda-510k.jpg K212859 - First Relief K212859 is a FDA 510(k) cleared neurology medical device. Manufacturer: Dyansys, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k213031/ 2021-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k213031-solex-7-intravascular-heat-exchange-fda-510k.jpg K213031 - Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console K213031 is a FDA 510(k) cleared neurology medical device. Manufacturer: Zoll Circulation, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k213076/ 2021-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k213076-aspenmed-fda-510k.jpg K213076 - AspenMed+ K213076 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Aspen Glove Sdn. Bhd.. Cleared Dec 2021. https://www.510kdatabase.net/k213275/ 2021-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k213275-echogo-core-20-fda-510k.jpg K213275 - EchoGo Core (2.0) K213275 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ultromics Limited. Cleared Dec 2021. https://www.510kdatabase.net/k213531/ 2021-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k213531-tr-band-radial-compression-device-fda-510k.jpg K213531 - TR BAND Radial Compression Device K213531 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corporation. Cleared Dec 2021. https://www.510kdatabase.net/k210559/ 2021-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k210559-atoz-mini-screw-fda-510k.jpg K210559 - ATOZ Mini-Screw K210559 is a FDA 510(k) cleared dental medical device. Manufacturer: Mk Meditech, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k211457/ 2021-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k211457-powder-free-nitrile-examination-gloves-fda-510k.jpg K211457 - Powder Free Nitrile Examination Gloves (Blue, Black, Indigo) K211457 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ammex Corporation. Cleared Dec 2021. https://www.510kdatabase.net/k211624/ 2021-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k211624-usa-gloves-nitrile-powder-free-exam-fda-510k.jpg K211624 - USA Gloves Nitrile Powder Free Exam Gloves K211624 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Usa Gloves. Cleared Dec 2021. https://www.510kdatabase.net/k212932/ 2021-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k212932-nobel-biocare-nobelspeedy-groovy-fda-510k.jpg K212932 - Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC PureSet Tray K212932 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Nobel Biocare Services AG. Cleared Dec 2021. https://www.510kdatabase.net/k213048/ 2021-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k213048-nitrile-patient-examination-gloves-fda-510k.jpg K213048 - Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs) K213048 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Huayuan Medical Technology(Shangqiu) Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k213051/ 2021-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k213051-nitrile-patient-examination-gloves-fda-510k.jpg K213051 - Nitrile Patient Examination Gloves (Tested for Use with Chemotherapy Drugs) K213051 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Yunnan Huazhiyuan Medical Technology Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k193081/ 2021-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k193081-rheonix-sti-triplex-assay-rheonix-fda-510k.jpg K193081 - Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit K193081 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Rheonix, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k200943/ 2021-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k200943-circa-s-cath-m-esophageal-temperature-fda-510k.jpg K200943 - Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System K200943 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Circa Scientific, LLC. Cleared Dec 2021. https://www.510kdatabase.net/k203424/ 2021-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k203424-quantum-perfusion-blood-oxygenator-ecc-fda-510k.jpg K203424 - Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum Perfusion Blood Oxygenator ECC VT160-E1, Quantum Perfusion Blood Oxygenator ECC VT160-E2 K203424 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Qura S.R.L. Cleared Dec 2021. https://www.510kdatabase.net/k203695/ 2021-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k203695-nobreath-fda-510k.jpg K203695 - NObreath® K203695 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bedfont Scientific, Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k203821/ 2021-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k203821-donagamex-blue-performance-protective-fda-510k.jpg K203821 - Donagamex Blue Performance Protective Gown K203821 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Dong Nai Garment Corporation (Donagamex). Cleared Dec 2021. https://www.510kdatabase.net/k210077/ 2021-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k210077-med-rf-4000-fda-510k.jpg K210077 - MED RF 4000 K210077 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: F Care Systems USA, LLC. Cleared Dec 2021. https://www.510kdatabase.net/k210102/ 2021-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k210102-topwide-surgical-face-mask-fda-510k.jpg K210102 - Topwide Surgical Face Mask K210102 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Topwide (Hubei) Medical Products Manufacturer. Cleared Dec 2021. https://www.510kdatabase.net/k210825/ 2021-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k210825-revitive-medic-coach-model-number-5575aq-fda-510k.jpg K210825 - Revitive Medic Coach (Model Number 5575AQ) K210825 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Actegy , Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k210871/ 2021-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k210871-pdo-max-suture-with-dual-needle-fda-510k.jpg K210871 - PDO Max Suture with Dual Needle K210871 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Pdo Max, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k210914/ 2021-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k210914-sterile-syringe-for-single-use-fda-510k.jpg K210914 - Sterile Syringe for Single Use K210914 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Suyun Medical Material Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k210931/ 2021-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k210931-libby-iaaa-v10-fda-510k.jpg K210931 - Libby IAAA v1.0 K210931 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Dyad Medical, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k211172/ 2021-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k211172-single-use-electrosurgical-knife-with-fda-510k.jpg K211172 - Single Use Electrosurgical Knife with Fluid Pump System K211172 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Micro-Tech (Nanjing) Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k211209/ 2021-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k211209-hycare-med-nitrile-examination-gloves-fda-510k.jpg K211209 - Hycare Med+ Nitrile Examination Gloves K211209 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hycare International Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k211531/ 2021-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k211531-cordless-prophy-system-model-i-polish-fda-510k.jpg K211531 - Cordless Prophy System, Model: i-Polish K211531 is a FDA 510(k) cleared dental medical device. Manufacturer: Guilin Woodpecker Medical Instrument Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k212059/ 2021-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k212059-surgical-face-mask-fda-510k.jpg K212059 - Surgical Face Mask K212059 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zhongshan Saifute Labor Protective Articles Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k212340/ 2021-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k212340-emboguard-balloon-guide-catheter-fda-510k.jpg K212340 - EMBOGUARD Balloon Guide Catheter K212340 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neuravi Limited. Cleared Dec 2021. https://www.510kdatabase.net/k212872/ 2021-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k212872-avenger-radial-head-system-fda-510k.jpg K212872 - Avenger Radial Head System K212872 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: In2bones USA, LLC. Cleared Dec 2021. https://www.510kdatabase.net/k213381/ 2021-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k213381-physica-system-fda-510k.jpg K213381 - Physica system K213381 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Lima Corporate S.P.A.. Cleared Dec 2021. https://www.510kdatabase.net/k213397/ 2021-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k213397-inkspace-imaging-pediatric-body-array-fda-510k.jpg K213397 - InkSpace Imaging Pediatric Body Array K213397 is a FDA 510(k) cleared radiology medical device. Manufacturer: Inkspace Imaging, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k213627/ 2021-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k213627-rf-vapor-system-fda-510k.jpg K213627 - RF Vapor System K213627 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Aqua Medical, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k213644/ 2021-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k213644-arthrex-knotless-mini-tightropes-fda-510k.jpg K213644 - Arthrex Knotless Mini TightRopes K213644 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k213715/ 2021-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k213715-revolution-apex-revolution-apex-elite-fda-510k.jpg K213715 - Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT K213715 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems, LLC. Cleared Dec 2021. https://www.510kdatabase.net/k202803/ 2021-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k202803-activmotion-s-dto-fda-510k.jpg K202803 - Activmotion S DTO K202803 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Newclip Technics. Cleared Dec 2021. https://www.510kdatabase.net/k202818/ 2021-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k202818-voyant-fine-fusion-device-eb230-fda-510k.jpg K202818 - Voyant Fine Fusion Device (EB230) K202818 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Applied Medical. Cleared Dec 2021. https://www.510kdatabase.net/k210355/ 2021-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k210355-surgical-gown-model-surgical-gown-hp-3-fda-510k.jpg K210355 - Surgical Gown, Model: surgical gown-hp-3 K210355 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Weihai Dishang Medical Technology Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k211217/ 2021-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k211217-profound-matrix-fda-510k.jpg K211217 - Profound Matrix K211217 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Candela Corporation. Cleared Dec 2021. https://www.510kdatabase.net/k211277/ 2021-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k211277-theia-npwt-foam-wound-dressing-kit-fda-510k.jpg K211277 - Theia NPWT Foam Wound Dressing Kit K211277 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Clear Choice Therapeutics, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k211378/ 2021-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k211378-lm-surgical-mask-level-3-lm-surgical-fda-510k.jpg K211378 - LM Surgical Mask Level 3, LM Surgical Mask Level 2, K211378 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Liberty Mask, LLC. Cleared Dec 2021. https://www.510kdatabase.net/k211471/ 2021-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k211471-balanced-knee-system-uni-fda-510k.jpg K211471 - Balanced Knee System Uni K211471 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ortho Development Corporation. Cleared Dec 2021. https://www.510kdatabase.net/k212055/ 2021-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k212055-connected-or-hub-with-device-and-voice-fda-510k.jpg K212055 - Connected OR Hub with Device and Voice Control K212055 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker Corporation. Cleared Dec 2021. https://www.510kdatabase.net/k212402/ 2021-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k212402-mivi-q-distal-access-catheter-fda-510k.jpg K212402 - MIVI Q Distal Access Catheter K212402 is a FDA 510(k) cleared neurology medical device. Manufacturer: Mivi Neuroscience, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k212420/ 2021-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k212420-brainlab-elements-brainlab-elements-fda-510k.jpg K212420 - Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio K212420 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab AG. Cleared Dec 2021. https://www.510kdatabase.net/k212616/ 2021-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k212616-koios-ds-fda-510k.jpg K212616 - Koios DS K212616 is a FDA 510(k) cleared radiology medical device. Manufacturer: Koios Medical, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k212630/ 2021-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k212630-tango-tango-reflex-ultra-q-ultra-q-fda-510k.jpg K212630 - Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo K212630 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Ellex Medical Pty, Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k212645/ 2021-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k212645-at-fda-510k.jpg K212645 - AT K212645 is a FDA 510(k) cleared general hospital medical device. Manufacturer: At Glove Engineering Sdn. Bhd. Cleared Dec 2021. https://www.510kdatabase.net/k212898/ 2021-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k212898-blue-nitrile-powder-free-patient-fda-510k.jpg K212898 - Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With Chemotherapy Drugs K212898 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Rimba Glove Snd Bhd. Cleared Dec 2021. https://www.510kdatabase.net/k212985/ 2021-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k212985-6mp-color-lcd-monitor-cl-s600-fda-510k.jpg K212985 - 6MP Color LCD Monitor CL-S600 K212985 is a FDA 510(k) cleared radiology medical device. Manufacturer: Jvckenwood Corporation. Cleared Dec 2021. https://www.510kdatabase.net/k213020/ 2021-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k213020-ipl-hair-removal-machine-fda-510k.jpg K213020 - IPL hair removal machine K213020 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Borria Technology Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k213407/ 2021-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k213407-ulticare-disposable-pen-needles-fda-510k.jpg K213407 - UltiCare Disposable Pen Needles K213407 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ultimed Incorporated. Cleared Dec 2021. https://www.510kdatabase.net/k213463/ 2021-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k213463-nightowl-fda-510k.jpg K213463 - NightOwl K213463 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Ectosense NV. Cleared Dec 2021. https://www.510kdatabase.net/k213628/ 2021-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k213628-vbrain-fda-510k.jpg K213628 - VBrain K213628 is a FDA 510(k) cleared radiology medical device. Manufacturer: Vysioneer, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k213733/ 2021-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k213733-ponto-5-superpower-fda-510k.jpg K213733 - Ponto 5 SuperPower K213733 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Oticon Medical AB. Cleared Dec 2021. https://www.510kdatabase.net/k213916/ 2021-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k213916-archform-orthodontic-software-system-fda-510k.jpg K213916 - ArchForm Orthodontic Software System K213916 is a FDA 510(k) cleared dental medical device. Manufacturer: Archform, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k200176/ 2021-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k200176-freedom-integrated-syringe-infusion-fda-510k.jpg K200176 - FREEDOM Integrated Syringe Infusion System K200176 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Repro-Med Systems, Inc. Dba Koru Medical Systems. Cleared Dec 2021. https://www.510kdatabase.net/k202822/ 2021-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k202822-helianthus-fda-510k.jpg K202822 - Helianthus K202822 is a FDA 510(k) cleared radiology medical device. Manufacturer: Metaltronica Spa. Cleared Dec 2021. https://www.510kdatabase.net/k202823/ 2021-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k202823-innomed-npwt-silicone-foam-dressing-fda-510k.jpg K202823 - Innomed NPWT Silicone Foam Dressing K202823 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Zhejiang Longterm Medical Technology Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k210212/ 2021-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k210212-psychemedics-homogeneous-enzyme-fda-510k.jpg K210212 - Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in Hair K210212 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Psychemedics Corporation. Cleared Dec 2021. https://www.510kdatabase.net/k210223/ 2021-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k210223-transcutaneous-electrical-nerve-fda-510k.jpg K210223 - Transcutaneous Electrical Nerve Stimulator K210223 is a FDA 510(k) cleared neurology medical device. Manufacturer: Top-Rank Health Care Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k210405/ 2021-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k210405-protec-usa-ezdoff-gown-fda-510k.jpg K210405 - ProTEC-USA EZDoff Gown K210405 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cadillac Products, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k210965/ 2021-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k210965-revive-light-therapy-essentials-fda-510k.jpg K210965 - reVive Light Therapy Essentials K210965 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Led Technologies, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k211039/ 2021-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k211039-bit-motion-fda-510k.jpg K211039 - BIT-Motion K211039 is a FDA 510(k) cleared radiology medical device. Manufacturer: Dde Mri Solutions, Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k211114/ 2021-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k211114-will3d-fda-510k.jpg K211114 - Will3D K211114 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hdx Will Corp.. Cleared Dec 2021. https://www.510kdatabase.net/k211539/ 2021-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k211539-sensititre-yeastone-susceptibility-fda-510k.jpg K211539 - Sensititre YeastOne Susceptibility System with Voriconazole in the dilution range of 0.008 - 8 ug/mL K211539 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Thermo Fisher Scientific. Cleared Dec 2021. https://www.510kdatabase.net/k211803/ 2021-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k211803-healthppt-fda-510k.jpg K211803 - HealthPPT K211803 is a FDA 510(k) cleared radiology medical device. Manufacturer: Zebra Medical Vision, Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k212351/ 2021-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k212351-revolution-peripheral-atherectomy-system-fda-510k.jpg K212351 - Revolution Peripheral Atherectomy System K212351 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Rex Medical, L.P.. Cleared Dec 2021. https://www.510kdatabase.net/k212398/ 2021-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k212398-surgical-face-mask-non-sterile-fda-510k.jpg K212398 - Surgical Face Mask (Non-sterile) K212398 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hubei Kimsoul Industrial Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k212781/ 2021-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k212781-posterior-fusion-plateha-posterior-fda-510k.jpg K212781 - Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA Minuteman G3 MIS Fusion Plate, HA Minuteman G3-R MIS Fusion Plate K212781 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinal Simplicity, LLC. Cleared Dec 2021. https://www.510kdatabase.net/k212817/ 2021-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k212817-merit-siege-vascular-plug-fda-510k.jpg K212817 - Merit Siege Vascular Plug K212817 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical System, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k212861/ 2021-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k212861-surgical-gown-reinforced-surgical-gown-fda-510k.jpg K212861 - Surgical Gown, Reinforced Surgical Gown K212861 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wuhan Zonsen Medical Products Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k212903/ 2021-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k212903-simpact-sacroiliac-joint-fixation-system-fda-510k.jpg K212903 - SIMPACT Sacroiliac Joint Fixation System K212903 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k212919/ 2021-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k212919-disposable-nitrile-examination-gloves-fda-510k.jpg K212919 - Disposable Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) K212919 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiujiang Taixin Technology Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k212944/ 2021-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k212944-disposable-surgical-mask-fda-510k.jpg K212944 - Disposable Surgical Mask K212944 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Heilongjiang Yinjia Medical Equipment Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k213092/ 2021-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k213092-cellusheet-cellufil-fda-510k.jpg K213092 - Cellusheet, Cellufil K213092 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Human Biosciences, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k213155/ 2021-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k213155-rt-mind-ai-fda-510k.jpg K213155 - RT-Mind-AI K213155 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medmind Technology Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k213443/ 2021-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k213443-insignia-anterior-cervical-plate-system-fda-510k.jpg K213443 - Insignia™ Anterior Cervical Plate System K213443 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k213631/ 2021-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k213631-chocolate-pta-balloon-catheter-fda-510k.jpg K213631 - Chocolate PTA Balloon Catheter K213631 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k213728/ 2021-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k213728-serranator-pta-serration-balloon-fda-510k.jpg K213728 - Serranator PTA Serration Balloon Catheter K213728 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cagent Vascular, LLC. Cleared Dec 2021. https://www.510kdatabase.net/k200932/ 2021-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k200932-blood-collection-needles-fda-510k.jpg K200932 - Blood Collection Needles K200932 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Vacutest Kima Srl. Cleared Dec 2021. https://www.510kdatabase.net/k202848/ 2021-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k202848-s2-pigment-removal-system-fda-510k.jpg K202848 - S2 Pigment Removal System K202848 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lightsense Technologies, Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k203716/ 2021-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k203716-pico-single-use-negative-pressure-fda-510k.jpg K203716 - PICO Single Use Negative Pressure Wound Therapy System, PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System K203716 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith and Nephew Medical Limited. Cleared Dec 2021. https://www.510kdatabase.net/k210481/ 2021-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k210481-instant-20s-indicator-fda-510k.jpg K210481 - Instant 20s Indicator K210481 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: True Indicating, LLC. Cleared Dec 2021. https://www.510kdatabase.net/k210744/ 2021-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k210744-surgical-mask-fda-510k.jpg K210744 - Surgical Mask K210744 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Chongqing PA Xijia Biotechnology Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k210827/ 2021-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k210827-zepto-precision-capsulotomy-system-fda-510k.jpg K210827 - ZEPTO Precision Capsulotomy System K210827 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Centricity Vision, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k212538/ 2021-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k212538-dess-dental-implants-fda-510k.jpg K212538 - DESS Dental Implants K212538 is a FDA 510(k) cleared dental medical device. Manufacturer: Terrats Medical SL. Cleared Dec 2021. https://www.510kdatabase.net/k212574/ 2021-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k212574-surgical-face-mask-fda-510k.jpg K212574 - Surgical Face Mask K212574 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Xiantao Deming Healthcare Products Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k212675/ 2021-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k212675-aspira-peritoneal-drainage-system-fda-510k.jpg K212675 - Aspira Peritoneal Drainage System K212675 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k212832/ 2021-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k212832-timewaver-frequency-fda-510k.jpg K212832 - TimeWaver Frequency K212832 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Timewaver Production GmbH. Cleared Dec 2021. https://www.510kdatabase.net/k212904/ 2021-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k212904-seaspine-waveform-c-interbody-system-fda-510k.jpg K212904 - SeaSpine WaveForm C Interbody System K212904 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared Dec 2021. https://www.510kdatabase.net/k212958/ 2021-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k212958-mridian-linac-system-fda-510k.jpg K212958 - MRIdian Linac System K212958 is a FDA 510(k) cleared radiology medical device. Manufacturer: Viewray, Incorporated. Cleared Dec 2021. https://www.510kdatabase.net/k213029/ 2021-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k213029-nitrile-examination-gloves-powder-free-fda-510k.jpg K213029 - Nitrile Examination Gloves (Powder free, Blue) K213029 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Weihai Hongyu Nonwoven Fabric Products Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k213422/ 2021-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k213422-ekosonic-endovascular-device-ekos-fda-510k.jpg K213422 - EkoSonic Endovascular Device, EKOS+ Endovascular Device K213422 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Dec 2021. https://www.510kdatabase.net/k202794/ 2021-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k202794-surgical-face-mask-f-y1-a-fda-510k.jpg K202794 - Surgical face mask: F-Y1-A K202794 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiande Chaomei Daily Chemicals Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k210388/ 2021-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k210388-non-sterile-nitrile-powder-free-fda-510k.jpg K210388 - Non Sterile Nitrile Powder Free Examination Gloves – Blue, Green and Black color K210388 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Mexpo International, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k211572/ 2021-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k211572-aesculap-slim-clip-applier-fda-510k.jpg K211572 - Aesculap Slim Clip Applier K211572 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k211942/ 2021-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k211942-heating-lumbar-therapy-cushion-model-fda-510k.jpg K211942 - Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B) K211942 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Shenzhen Osto Technology Company Limited. Cleared Dec 2021. https://www.510kdatabase.net/k212060/ 2021-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k212060-nexus-ultrasonic-surgical-aspirator-fda-510k.jpg K212060 - neXus Ultrasonic Surgical Aspirator System K212060 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Misonix, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k212186/ 2021-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k212186-philips-radiology-smart-assistant-fda-510k.jpg K212186 - Philips Radiology Smart Assistant K212186 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Dmc GmbH. Cleared Dec 2021. https://www.510kdatabase.net/k212221/ 2021-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k212221-diazyme-dz-lite-iflash-total-beta-hcg-fda-510k.jpg K212221 - Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer K212221 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diazyme Laboratories, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k212428/ 2021-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k212428-centerpiece-plate-fixation-system-fda-510k.jpg K212428 - Centerpiece Plate Fixation System K212428 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Dec 2021. https://www.510kdatabase.net/k212706/ 2021-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k212706-sleepright-prorx-custom-dental-guard-fda-510k.jpg K212706 - SleepRight ProRx + Custom Dental Guard, SleepRight ProRx Custom Dental Guard K212706 is a FDA 510(k) cleared dental medical device. Manufacturer: Splintek, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k212869/ 2021-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k212869-disposable-surgical-gown-disposable-fda-510k.jpg K212869 - Disposable Surgical Gown, Disposable Reinforced Surgical Gown K212869 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Fugou County Shenxiang Manufacturing Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k212890/ 2021-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k212890-nyquistiq-fda-510k.jpg K212890 - Nyquist.IQ K212890 is a FDA 510(k) cleared radiology medical device. Manufacturer: Omega Medical Imaging, LLC. Cleared Dec 2021. https://www.510kdatabase.net/k212918/ 2021-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k212918-heat-stimplus-fda-510k.jpg K212918 - Heat StimPlus K212918 is a FDA 510(k) cleared neurology medical device. Manufacturer: Famidoc Technology Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k212924/ 2021-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k212924-nitrile-examination-gloves-fda-510k.jpg K212924 - Nitrile Examination Gloves K212924 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shanxi Nacosa Medical Technology Co.,Ltd. Cleared Dec 2021. https://www.510kdatabase.net/k212925/ 2021-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k212925-disposable-surgical-gown-fda-510k.jpg K212925 - Disposable Surgical Gown K212925 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Henan Robestain Medical Products Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k213069/ 2021-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k213069-colink-neofuse-plating-system-fda-510k.jpg K213069 - CoLink NeoFuse Plating System K213069 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: In2bones USA, LLC. Cleared Dec 2021. https://www.510kdatabase.net/k213176/ 2021-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k213176-disposable-nitrile-powder-free-fda-510k.jpg K213176 - Disposable Nitrile Powder-Free Examination Gloves K213176 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Anhui Zhong Lian Latex Gloves Manufacturing Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k213700/ 2021-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k213700-multix-impact-multix-impact-c-fda-510k.jpg K213700 - MULTIX Impact, MULTIX Impact C K213700 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k212085/ 2021-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k212085-siam-ntd-nitrile-powder-free-fda-510k.jpg K212085 - Siam NTD+ Nitrile Powder-Free Examination gloves K212085 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Siam Ntd Corporation Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k212182/ 2021-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k212182-iconic-nitrile-glove-fda-510k.jpg K212182 - Iconic Nitrile Glove K212182 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Iconic Medicare Sdn Bhd. Cleared Dec 2021. https://www.510kdatabase.net/k212840/ 2021-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k212840-nitrile-gloves-model-ne01-fda-510k.jpg K212840 - Nitrile Gloves (Model: NE01) K212840 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Byd Auto Industry Company Limited. Cleared Dec 2021. https://www.510kdatabase.net/k212867/ 2021-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k212867-medical-surgical-mask-fda-510k.jpg K212867 - Medical Surgical Mask K212867 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Nanchang Kanghua Health Materials Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k212899/ 2021-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k212899-disposable-vinylnitrile-blend-medical-fda-510k.jpg K212899 - Disposable Vinyl/Nitrile Blend Medical Examination Gloves K212899 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bytech Dongtai Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k201600/ 2021-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k201600-infrared-thermometer-models-kft-22m-fda-510k.jpg K201600 - Infrared thermometer, models KFT-22M, KFT-22, KFT-23, KFT-24, KFT-25, KFT-26, KFT-27, KFT-28 K201600 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Kangfu Medical Equipment Factory. Cleared Dec 2021. https://www.510kdatabase.net/k202510/ 2021-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k202510-amg-pmp-infant-fda-510k.jpg K202510 - AMG PMP Infant K202510 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Eurosets S.R.L. Cleared Dec 2021. https://www.510kdatabase.net/k203539/ 2021-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k203539-unico-global-level-3-surgical-gown-fda-510k.jpg K203539 - Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE) K203539 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Unicoglobal, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k203615/ 2021-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k203615-dental-scaler-and-air-polisher-fda-510k.jpg K203615 - Dental Scaler and Air Polisher K203615 is a FDA 510(k) cleared dental medical device. Manufacturer: Guilin Woodpecker Medical Instrument Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k203723/ 2021-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k203723-branchor-balloon-guide-catheter-fda-510k.jpg K203723 - Branchor Balloon Guide Catheter K203723 is a FDA 510(k) cleared neurology medical device. Manufacturer: Asahi Intecc Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k203743/ 2021-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k203743-exa-fda-510k.jpg K203743 - EXA K203743 is a FDA 510(k) cleared radiology medical device. Manufacturer: Konica Minolta Healthcare Americas, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k210004/ 2021-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k210004-i8-tanning-booth-fda-510k.jpg K210004 - i8 Tanning Booth K210004 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ultrasun International B.V.. Cleared Dec 2021. https://www.510kdatabase.net/k210842/ 2021-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k210842-versys-cemented-revisioncalcar-fda-510k.jpg K210842 - VerSys Cemented Revision/Calcar K210842 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k210847/ 2021-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k210847-ultraclear-fractional-laser-system-fda-510k.jpg K210847 - UltraClear Fractional Laser System K210847 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Fa International, LP. Cleared Dec 2021. https://www.510kdatabase.net/k211560/ 2021-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k211560-airvo-nebulizer-adapter-fda-510k.jpg K211560 - Airvo Nebulizer Adapter K211560 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Fisher & Paykel Healthcare Limited. Cleared Dec 2021. https://www.510kdatabase.net/k211612/ 2021-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k211612-medline-unite-reflex-dynamic-discs-fda-510k.jpg K211612 - Medline UNITE REFLEX Dynamic Discs K211612 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medline Industries, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k211997/ 2021-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k211997-8-mm-sureform-30-curved-tip-stapler-8-fda-510k.jpg K211997 - 8 mm SureForm 30 Curved-Tip Stapler, 8 mm SureForm 30 Stapler, SureForm 30 Reloads K211997 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k212137/ 2021-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k212137-x-clever-fda-510k.jpg K212137 - X-Clever K212137 is a FDA 510(k) cleared radiology medical device. Manufacturer: Lg Electronics.Inc. Cleared Dec 2021. https://www.510kdatabase.net/k212176/ 2021-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k212176-cintec-histology-fda-510k.jpg K212176 - CINtec Histology K212176 is a FDA 510(k) cleared pathology medical device. Manufacturer: Ventana Medical Systems, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k212349/ 2021-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k212349-powder-free-white-blue-pink-black-fda-510k.jpg K212349 - Powder Free, White, Blue, Pink, Black Nitrile Synthetic Rubber Examination Gloves K212349 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medi Legion Sdn.Bhd. Cleared Dec 2021. https://www.510kdatabase.net/k212435/ 2021-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k212435-comprehensive-humeral-fracture-fda-510k.jpg K212435 - Comprehensive Humeral Fracture Positioning Sleeves K212435 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k212577/ 2021-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k212577-dess-dental-smart-solutions-fda-510k.jpg K212577 - DESS Dental Smart Solutions K212577 is a FDA 510(k) cleared dental medical device. Manufacturer: Terrats Medical SL. Cleared Dec 2021. https://www.510kdatabase.net/k212850/ 2021-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k212850-comfortpro-blue-nitrile-examination-fda-510k.jpg K212850 - ComfortPro Blue Nitrile Examination Gloves Powder Free K212850 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Thai Rubber Industry Company Limited. Cleared Dec 2021. https://www.510kdatabase.net/k212922/ 2021-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k212922-nitrile-examination-gloves-fda-510k.jpg K212922 - Nitrile Examination Gloves K212922 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hsk Medical Apparatus Foshan China Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k213394/ 2021-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k213394-vy-spine-vyspan-pct-system-fda-510k.jpg K213394 - Vy Spine™ VySpan™ PCT System K213394 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Vy Spine, LLC. Cleared Dec 2021. https://www.510kdatabase.net/k213460/ 2021-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k213460-invictus-spinal-fixation-system-fda-510k.jpg K213460 - Invictus Spinal Fixation System K213460 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k213543/ 2021-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k213543-neurostar-tms-therapy-system-neurostar-fda-510k.jpg K213543 - NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health K213543 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neuronetics, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k213637/ 2021-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k213637-jazz-solo-sensor-fda-510k.jpg K213637 - JAZZ Solo sensor K213637 is a FDA 510(k) cleared radiology medical device. Manufacturer: Jazz Imaging, LLC Dba Jazz Imaging. Cleared Dec 2021. https://www.510kdatabase.net/k213638/ 2021-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k213638-traveler-0038-stylet-portal-vein-fda-510k.jpg K213638 - Traveler 0.038 Stylet Portal Vein Access (TPS001), Traveler 21ga Needle Portal Vein Access Set (TPS002), Traveler 16ga Needle Portal Vein Access Set (TPS003) K213638 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Argon Medical Devices. Cleared Dec 2021. https://www.510kdatabase.net/den200041/ 2021-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/den200041-comfort-marker-20-fda-510k.jpg DEN200041 - Comfort Marker 2.0. DEN200041 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medical Precision BV. Cleared Dec 2021. https://www.510kdatabase.net/k201764/ 2021-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k201764-infinity-acute-care-system-iacs-fda-510k.jpg K201764 - Infinity Acute Care System (IACS) Monitoring Solution K201764 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Draeger Medical Systems, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k211949/ 2021-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k211949-airstrip-one-web-client-with-alarm-fda-510k.jpg K211949 - AirStrip ONE Web Client with Alarm Communication Management (ACM) K211949 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Airstrip Technologies, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k212034/ 2021-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k212034-lospa-tkr-system-fda-510k.jpg K212034 - LOSPA TKR System K212034 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corentec Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k212329/ 2021-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k212329-plasma-iq-fda-510k.jpg K212329 - Plasma IQ K212329 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Neauvia North America, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k212466/ 2021-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k212466-lvivo-seamless-fda-510k.jpg K212466 - LVivo Seamless K212466 is a FDA 510(k) cleared radiology medical device. Manufacturer: Dia Imaging Analysis, Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k213149/ 2021-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k213149-voco-retraction-paste-fda-510k.jpg K213149 - VOCO Retraction Paste K213149 is a FDA 510(k) cleared dental medical device. Manufacturer: Voco GmbH. Cleared Dec 2021. https://www.510kdatabase.net/k213359/ 2021-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k213359-seaspine-waveform-c-interbody-system-fda-510k.jpg K213359 - SeaSpine WaveForm, C Interbody System K213359 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared Dec 2021. https://www.510kdatabase.net/k213371/ 2021-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k213371-disposable-medical-nitrile-examination-fda-510k.jpg K213371 - Disposable Medical Nitrile Examination Gloves (Model:XYS-001) K213371 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Anhui Xinyisheng Medical Technology Co.,Ltd. Cleared Dec 2021. https://www.510kdatabase.net/k213530/ 2021-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k213530-nextra-ch-cannulated-hammertoe-system-fda-510k.jpg K213530 - Nextra CH Cannulated Hammertoe System K213530 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nextremity Solutions, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k210817/ 2021-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k210817-cb-50-hybrid-fda-510k.jpg K210817 - C&B 5.0 Hybrid K210817 is a FDA 510(k) cleared dental medical device. Manufacturer: Arum Dentistry Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k211487/ 2021-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k211487-maf-guard-fda-510k.jpg K211487 - MAF Guard K211487 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Maf Clothing Pvt Ltd Unit-3. Cleared Dec 2021. https://www.510kdatabase.net/k211629/ 2021-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k211629-infrared-forehead-thermometer-ld-ft-100b-fda-510k.jpg K211629 - Infrared forehead thermometer LD-FT-100B K211629 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Honsun (Nantong) Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k211898/ 2021-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k211898-asahi-pci-guide-wire-asahi-confianza-fda-510k.jpg K211898 - ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20 K211898 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Asahi Intecc Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k212075/ 2021-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k212075-shurfit-lumbar-interbody-system-fda-510k.jpg K212075 - ShurFit Lumbar Interbody System K212075 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Precision Spine, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k212524/ 2021-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k212524-anteralign-spinal-system-with-titan-fda-510k.jpg K212524 - Anteralign Spinal System with Titan nanoLOCK Surface Technology K212524 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k212573/ 2021-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k212573-picolo-premium-fda-510k.jpg K212573 - PicoLO Premium K212573 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Laseroptek Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k212639/ 2021-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k212639-disposable-medical-nitrile-examination-fda-510k.jpg K212639 - Disposable Medical Nitrile Examination Gloves (Non sterile) K212639 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Nanfang Medical Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k212983/ 2021-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k212983-injectable-root-canal-bioceramic-sealer-fda-510k.jpg K212983 - Injectable Root Canal Bioceramic Sealer K212983 is a FDA 510(k) cleared dental medical device. Manufacturer: Beijing C-Root Dental Medical Devices Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k213156/ 2021-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k213156-bd-nano-2nd-gen-pen-needle-fda-510k.jpg K213156 - BD Nano 2nd Gen Pen Needle K213156 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson and Company. Cleared Dec 2021. https://www.510kdatabase.net/k211309/ 2021-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k211309-endomina-system-fda-510k.jpg K211309 - endomina system K211309 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Endo Tools Therapeutics S.A.. Cleared Dec 2021. https://www.510kdatabase.net/k212302/ 2021-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k212302-baylab-3-ply-surgical-mask-beacon-i-fda-510k.jpg K212302 - BAYLAB 3-Ply Surgical Mask (BEACON I) K212302 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baylab USA, LLC. Cleared Dec 2021. https://www.510kdatabase.net/k212438/ 2021-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k212438-comfortpro-fda-510k.jpg K212438 - Comfortpro K212438 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Thai Rubber Industry Company Limited. Cleared Dec 2021. https://www.510kdatabase.net/k213303/ 2021-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k213303-makoto-intravascular-imaging-system-fda-510k.jpg K213303 - Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42, Peripheral 014 Imaging Catheter, TVC-E195-42 K213303 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Infraredx, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k213512/ 2021-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k213512-dermabond-prineo-skin-closure-system-fda-510k.jpg K213512 - DERMABOND PRINEO Skin Closure System K213512 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k211448/ 2021-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k211448-aquamax-etafilcon-a-daily-disposable-fda-510k.jpg K211448 - Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses K211448 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Pegavision Corporation. Cleared Dec 2021. https://www.510kdatabase.net/k211772/ 2021-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k211772-pmw01-procedure-mask-level-1-fda-510k.jpg K211772 - PMW01 Procedure Mask Level 1 K211772 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Defender Safety, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k211804/ 2021-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k211804-3delta-crown-fda-510k.jpg K211804 - 3Delta Crown K211804 is a FDA 510(k) cleared dental medical device. Manufacturer: Deltamed GmbH. Cleared Dec 2021. https://www.510kdatabase.net/k212235/ 2021-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k212235-surgical-face-mask-fda-510k.jpg K212235 - Surgical Face Mask K212235 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shanghai Yunqing Industrial Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k212381/ 2021-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k212381-versatap-versalat-duelock-versati-miniti-fda-510k.jpg K212381 - VersaTap, VersaLat, DueLock, VersaTi, MiniTi K212381 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ortho-Design (Pty), Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k212548/ 2021-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k212548-luxen-cl-dental-liquid-fda-510k.jpg K212548 - LUXEN CL Dental Liquid K212548 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentalmax Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k212827/ 2021-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k212827-jr-medic-blue-nitrile-examination-fda-510k.jpg K212827 - Jr Medic Blue Nitrile Examination Gloves Powder Free tested for use with Chemotherapy drugs K212827 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jr Engineering & Medical Technologies (M) Sdn. Bhd.. Cleared Dec 2021. https://www.510kdatabase.net/k212852/ 2021-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k212852-areustm-adapt-endoscopic-ultrasound-fda-510k.jpg K212852 - Areus(TM) Adapt Endoscopic Ultrasound Aspiration Needle, Tridemt(TM) Endoscopic Ultrasound Aspiration Needle K212852 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Micro-Tech (Nanjing) Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k213096/ 2021-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k213096-al-rad-companion-pulmonary-fda-510k.jpg K213096 - Al-Rad Companion (Pulmonary) K213096 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k213115/ 2021-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k213115-chena-c-spacer-system-fda-510k.jpg K213115 - CHENA-C Spacer System K213115 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Kahtnu Surgical, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k211561/ 2021-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k211561-invos-pm7100-patient-monitor-invos-fda-510k.jpg K211561 - INVOS PM7100 Patient Monitor, INVOS Pediatric rSO2 Sensor, INVOS Infant Regional Saturation Sensor (also referred to as OxyAlert NIRSensor) K211561 is a FDA 510(k) cleared neurology medical device. Manufacturer: Covidien, LLC. Cleared Dec 2021. https://www.510kdatabase.net/k212535/ 2021-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k212535-nitrile-powder-free-blue-examination-fda-510k.jpg K212535 - Nitrile Powder Free Blue Examination Gloves, Non-Sterile K212535 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Mah Sing Healthcare Sdn. Bhd.. Cleared Dec 2021. https://www.510kdatabase.net/k201435/ 2021-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k201435-molecular-flow-simulations-fda-510k.jpg K201435 - Molecular Flow Simulations K201435 is a FDA 510(k) cleared neurology medical device. Manufacturer: Therataxis, LLC. Cleared Dec 2021. https://www.510kdatabase.net/k210126/ 2021-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k210126-sodium-chloride-inhalation-solutions-3-fda-510k.jpg K210126 - Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10% K210126 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: The Ritedose Corporation. Cleared Dec 2021. https://www.510kdatabase.net/k210241/ 2021-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k210241-implastation-fda-510k.jpg K210241 - ImplaStation K210241 is a FDA 510(k) cleared radiology medical device. Manufacturer: Prodigident, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k210916/ 2021-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k210916-pvmed-contouring-software-fda-510k.jpg K210916 - PVmed Contouring Software K210916 is a FDA 510(k) cleared radiology medical device. Manufacturer: Perception Vision Medical Technologies Ltd.Co.. Cleared Dec 2021. https://www.510kdatabase.net/k211786/ 2021-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k211786-independent-corneal-viewing-chamber-fda-510k.jpg K211786 - Independent Corneal Viewing Chamber (IVC-21) K211786 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Bausch & Lomb, Incorporated. Cleared Dec 2021. https://www.510kdatabase.net/k212219/ 2021-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k212219-ahi-system-fda-510k.jpg K212219 - AHI System K212219 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Fifth Eye, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k212258/ 2021-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k212258-medline-cardiovascular-procedure-kit-fda-510k.jpg K212258 - Medline Cardiovascular Procedure Kit K212258 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medline Industries, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k212295/ 2021-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k212295-21hq513d-fda-510k.jpg K212295 - 21HQ513D K212295 is a FDA 510(k) cleared radiology medical device. Manufacturer: Lg Electronics.Inc. Cleared Dec 2021. https://www.510kdatabase.net/k212442/ 2021-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k212442-cydar-ev-series-b-and-cydar-ev-maps-fda-510k.jpg K212442 - Cydar EV (Series B) and Cydar EV Maps K212442 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cydar , Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k212500/ 2021-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k212500-artisential-trocar-fda-510k.jpg K212500 - ArtiSential Trocar K212500 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Livsmed, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k212807/ 2021-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k212807-surgical-masks-fda-510k.jpg K212807 - Surgical Masks K212807 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Weihai Hongyu Nonwoven Fabric Products Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k213067/ 2021-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k213067-solero-microwave-tissue-ablation-mta-fda-510k.jpg K213067 - Solero Microwave Tissue Ablation (MTA) System and Accessories K213067 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: AngioDynamics, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k213116/ 2021-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k213116-everyway-incontinence-stimulation-system-fda-510k.jpg K213116 - Everyway Incontinence Stimulation System K213116 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Everyway Medical Instruments Co.,Ltd. Cleared Dec 2021. https://www.510kdatabase.net/k213266/ 2021-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k213266-inspan-screwles-fusion-system-fda-510k.jpg K213266 - Inspan ScrewLES Fusion System K213266 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Lespine Innovations, LLC. Cleared Dec 2021. https://www.510kdatabase.net/k213580/ 2021-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k213580-adapter-sleeve-for-biolox-option-fda-510k.jpg K213580 - Adapter Sleeve for BIOLOX® OPTION Femoral Head, +10.5mm head length K213580 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Total Joint Othopedics, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/den200005/ 2021-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/den200005-klox-biophotonic-lumiheal-system-fda-510k.jpg DEN200005 - Klox Biophotonic LumiHeal System DEN200005 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Klox Technlogies, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k202175/ 2021-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k202175-oxylight-20-fda-510k.jpg K202175 - OxyLight 2.0 K202175 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Raja Trading Company, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k203745/ 2021-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k203745-aurora-evacuator-coag-fda-510k.jpg K203745 - AURORA Evacuator +Coag K203745 is a FDA 510(k) cleared neurology medical device. Manufacturer: Rebound Therapeutics. Cleared Dec 2021. https://www.510kdatabase.net/k211452/ 2021-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k211452-encevis-fda-510k.jpg K211452 - Encevis K211452 is a FDA 510(k) cleared neurology medical device. Manufacturer: Austrian Institute of Technology GmbH. Cleared Dec 2021. https://www.510kdatabase.net/k211721/ 2021-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k211721-ps-system-fda-510k.jpg K211721 - PS System K211721 is a FDA 510(k) cleared dental medical device. Manufacturer: Inter-Med, Inc.. Cleared Dec 2021. https://www.510kdatabase.net/k211773/ 2021-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k211773-single-use-surgical-mask-fda-510k.jpg K211773 - Single-use Surgical Mask K211773 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Taiwan Seafood and Fish Corporation. Cleared Dec 2021. https://www.510kdatabase.net/k211886/ 2021-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k211886-clivia-series-diagnostic-ultrasound-fda-510k.jpg K211886 - Clivia series Diagnostic Ultrasound System K211886 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Wisonic Medical Technology Co. , Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k212578/ 2021-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k212578-nitrile-disposable-examination-gloves-fda-510k.jpg K212578 - Nitrile disposable examination gloves K212578 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Xingyu Medical Tech Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k212740/ 2021-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k212740-puravita-medical-fold-flat-surgical-mask-fda-510k.jpg K212740 - Puravita Medical Fold Flat Surgical Mask K212740 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Puravita M, LLC. Cleared Dec 2021. https://www.510kdatabase.net/k212802/ 2021-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k212802-powder-free-nitrile-examination-glove-fda-510k.jpg K212802 - powder free nitrile examination glove - white, non-sterile K212802 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hong Seng Gloves Sdn Bhd. Cleared Dec 2021. https://www.510kdatabase.net/k212907/ 2021-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k212907-aimanfun-lumea-comfort-a-2789a-3588-fda-510k.jpg K212907 - Aimanfun Lumea Comfort, A-2789/A-3588 K212907 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Kam Yuen Plastic Products , Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k212950/ 2021-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k212950-fujifilm-video-laparoscope-el-r740m30-fda-510k.jpg K212950 - FUJIFILM Video Laparoscope EL-R740M30 K212950 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Fujifilm Corporaton. Cleared Dec 2021. https://www.510kdatabase.net/k210934/ 2021-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k210934-sphincterotome-short-wire-compatible-fda-510k.jpg K210934 - Sphincterotome / short-wire compatible, Sterile Sphincterotome K210934 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Micro-Tech (Nanjing) Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k211755/ 2021-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k211755-electric-breast-pump-fda-510k.jpg K211755 - Electric Breast Pump K211755 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Zhejiang Carebao Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k211959/ 2021-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k211959-milli-vaginal-dilator-fda-510k.jpg K211959 - Milli Vaginal Dilator K211959 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Materna Medical. Cleared Dec 2021. https://www.510kdatabase.net/k212050/ 2021-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k212050-ngm-wave-plif-cage-fda-510k.jpg K212050 - NGM WAVE PLIF Cage K212050 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: NGMedical GmbH. Cleared Dec 2021. https://www.510kdatabase.net/k212326/ 2021-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k212326-ac-cream-conductive-paste-fda-510k.jpg K212326 - AC Cream - Conductive paste K212326 is a FDA 510(k) cleared neurology medical device. Manufacturer: Spes Medica Srl. Cleared Dec 2021. https://www.510kdatabase.net/k212789/ 2021-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k212789-nitrile-examination-gloves-tested-for-fda-510k.jpg K212789 - Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) K212789 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 5r Med Instruments (Chengdu) Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k212804/ 2021-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k212804-powder-free-nitrile-examination-glove-fda-510k.jpg K212804 - Powder free nitrile examination glove- blue, non-sterile K212804 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hong Seng Gloves Sdn Bhd. Cleared Dec 2021. https://www.510kdatabase.net/k212864/ 2021-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k212864-ds-torsocardiac-15t-ds-msk-s-15t-ds-fda-510k.jpg K212864 - dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T K212864 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Healthcare (Suzhou) Co., Ltd.. Cleared Dec 2021. https://www.510kdatabase.net/k213305/ 2021-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k213305-vantage-fortian-15t-mrt-1550-v80-with-fda-510k.jpg K213305 - Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR K213305 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Dec 2021. https://www.510kdatabase.net/k202024/ 2021-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k202024-arrow-short-stem-humeral-system-fda-510k.jpg K202024 - ARROW Short Stem Humeral System K202024 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: FH Industrie. Cleared Nov 2021. https://www.510kdatabase.net/k210117/ 2021-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k210117-paltop-narrow-implant-fda-510k.jpg K210117 - Paltop Narrow Implant K210117 is a FDA 510(k) cleared dental medical device. Manufacturer: Paltop Advanced Dental Solutions, Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k210836/ 2021-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k210836-instrusafe-instrument-protection-system-fda-510k.jpg K210836 - InstruSafe Instrument Protection System K210836 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Summitt Medical, LLC. Cleared Nov 2021. https://www.510kdatabase.net/k211668/ 2021-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k211668-kardiamobile-card-fda-510k.jpg K211668 - KardiaMobile Card K211668 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: AliveCor, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k211696/ 2021-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k211696-disposable-surgical-face-mask-fda-510k.jpg K211696 - Disposable Surgical Face Mask K211696 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Anhui Cleanpro Pharmpack Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k212664/ 2021-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k212664-sherlock-fda-510k.jpg K212664 - Sherlock K212664 is a FDA 510(k) cleared dental medical device. Manufacturer: Open Implants, LLC. Cleared Nov 2021. https://www.510kdatabase.net/k203748/ 2021-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k203748-septicyte-rapid-fda-510k.jpg K203748 - SeptiCyte RAPID K203748 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Immunexpress, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k210930/ 2021-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k210930-acuvue-oasys-max-1-day-contact-lenses-fda-510k.jpg K210930 - ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A) K210930 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Johnson & Johnson Vision Care, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k212237/ 2021-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k212237-3d-cut-fda-510k.jpg K212237 - 3D-Cut K212237 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 3D-Side S.A.. Cleared Nov 2021. https://www.510kdatabase.net/k212762/ 2021-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k212762-geko-w-2-fda-510k.jpg K212762 - geko W-2 K212762 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Firstkind Limited. Cleared Nov 2021. https://www.510kdatabase.net/k212814/ 2021-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k212814-c2-cryoballoon-ablation-system-fda-510k.jpg K212814 - C2 CryoBalloon Ablation System K212814 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Pentax of America, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k213226/ 2021-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k213226-rct700-fda-510k.jpg K213226 - RCT700 K213226 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ray Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k202537/ 2021-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k202537-altms-magnetic-stimulation-therapy-fda-510k.jpg K202537 - ALTMS Magnetic Stimulation Therapy System K202537 is a FDA 510(k) cleared neurology medical device. Manufacturer: Remed Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k202842/ 2021-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k202842-medical-surgical-mask-fda-510k.jpg K202842 - Medical surgical mask K202842 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Henan Huibo Medical Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k210782/ 2021-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k210782-tablo-cartridge-fda-510k.jpg K210782 - Tablo Cartridge K210782 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Outset Medical, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k210833/ 2021-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k210833-portex-bluxl-extra-length-tracheostomy-fda-510k.jpg K210833 - Portex BLUxl Extra Length Tracheostomy Tube, BLUxl Suctionaid Extra Length Tracheostomy Tube, BLUxl Extra Length Tracheostomy Inner Cannula K210833 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Smiths Medical Asd, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k211139/ 2021-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k211139-cube-air-purifier-fda-510k.jpg K211139 - CUBE Air Purifier K211139 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Samsung Electronics Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k211541/ 2021-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k211541-mammoscreen-20-fda-510k.jpg K211541 - MammoScreen 2.0 K211541 is a FDA 510(k) cleared radiology medical device. Manufacturer: Therapixel. Cleared Nov 2021. https://www.510kdatabase.net/k211594/ 2021-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k211594-trevo-trak-21-microcatheter-fda-510k.jpg K211594 - Trevo Trak 21 Microcatheter K211594 is a FDA 510(k) cleared neurology medical device. Manufacturer: Stryker Neurovascular. Cleared Nov 2021. https://www.510kdatabase.net/k212488/ 2021-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k212488-synthetic-nitrile-examination-gloves-fda-510k.jpg K212488 - Synthetic Nitrile Examination Gloves K212488 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shandong Hongxin Chemicals Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k212722/ 2021-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k212722-nitrile-examination-gloves-fda-510k.jpg K212722 - Nitrile Examination Gloves K212722 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wuhan Huirui Technology Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k210009/ 2021-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k210009-guiding-catheter-fda-510k.jpg K210009 - Guiding Catheter K210009 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: CenterPoint Systems, LLC. Cleared Nov 2021. https://www.510kdatabase.net/k211169/ 2021-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k211169-bronchoscope-system-fda-510k.jpg K211169 - Bronchoscope System K211169 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Shanghai AnQing Medical Instrument Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k211295/ 2021-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k211295-surgical-mask-sterile-fda-510k.jpg K211295 - Surgical Mask (sterile) K211295 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Nanjing 3h Medical Products Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k211345/ 2021-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k211345-c-30-crown-kit-fda-510k.jpg K211345 - C-30 Crown Kit K211345 is a FDA 510(k) cleared dental medical device. Manufacturer: Perfect Fit Crowns, LLC. Cleared Nov 2021. https://www.510kdatabase.net/k211463/ 2021-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k211463-regulora-fda-510k.jpg K211463 - Regulora K211463 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Metame Health, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k211650/ 2021-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k211650-the-radian-mis-bunion-system-fda-510k.jpg K211650 - The Radian MIS Bunion System K211650 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nvision Biomedical Technologies, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k211744/ 2021-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k211744-non-contact-infrared-thermometer-model-fda-510k.jpg K211744 - Non-Contact Infrared Thermometer, model HL710H K211744 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Health & Life Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k211894/ 2021-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k211894-trachealator-fda-510k.jpg K211894 - Trachealator K211894 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Disa Medinotec. Cleared Nov 2021. https://www.510kdatabase.net/k211983/ 2021-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k211983-amra-profiler-fda-510k.jpg K211983 - AMRA Profiler K211983 is a FDA 510(k) cleared radiology medical device. Manufacturer: Amra Medical AB. Cleared Nov 2021. https://www.510kdatabase.net/k212223/ 2021-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k212223-atellica-ch-enzymatic-creatinine3-ecre3-fda-510k.jpg K212223 - Atellica CH Enzymatic Creatinine_3 (ECre3) K212223 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k212558/ 2021-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k212558-micropen-evo-fda-510k.jpg K212558 - MicroPen EVO K212558 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Eclipse Medcorp, LLC. Cleared Nov 2021. https://www.510kdatabase.net/k212633/ 2021-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k212633-disposable-isolation-gown-level-3-fda-510k.jpg K212633 - Disposable Isolation Gown -Level 3, Large, Blue, Disposable Isolation Gown - Level 3, X-Large, Blue K212633 is a FDA 510(k) cleared general hospital medical device. Manufacturer: String King Lacrosse, LLC. Cleared Nov 2021. https://www.510kdatabase.net/k213214/ 2021-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k213214-xpert-wrist-fda-510k.jpg K213214 - Xpert Wrist K213214 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Newclip Technics. Cleared Nov 2021. https://www.510kdatabase.net/k213455/ 2021-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k213455-controlrad-select-model-z-fda-510k.jpg K213455 - ControlRad Select Model Z K213455 is a FDA 510(k) cleared radiology medical device. Manufacturer: Controlrad, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k202445/ 2021-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k202445-hystero-v-hysteroscope-fda-510k.jpg K202445 - Hystero-V Hysteroscope K202445 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Hysterovue, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k203248/ 2021-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k203248-albumin-bcg2-fda-510k.jpg K203248 - Albumin BCG2 K203248 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Ireland Diagnostics Division. Cleared Nov 2021. https://www.510kdatabase.net/k210095/ 2021-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k210095-playboy-premium-silicone-lubricant-fda-510k.jpg K210095 - Playboy Premium Silicone Lubricant K210095 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Thai Nippon Rubber Industry Public Company Limited.. Cleared Nov 2021. https://www.510kdatabase.net/k211342/ 2021-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k211342-sofia-2-campylobacter-fia-fda-510k.jpg K211342 - Sofia 2 Campylobacter FIA K211342 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Quidel Corporation. Cleared Nov 2021. https://www.510kdatabase.net/k211347/ 2021-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k211347-uretero1-ureteroscope-system-fda-510k.jpg K211347 - Uretero1 Ureteroscope System K211347 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: STERIS Corporation. Cleared Nov 2021. https://www.510kdatabase.net/k211387/ 2021-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k211387-breathe-easy-mobile-respiratory-fda-510k.jpg K211387 - Breathe Easy Mobile Respiratory Monitor (MRM) K211387 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sound Life Sciences, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k211432/ 2021-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k211432-myomics-q-fda-510k.jpg K211432 - Myomics Q K211432 is a FDA 510(k) cleared radiology medical device. Manufacturer: Phantomics, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k211562/ 2021-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k211562-virtue-rf-fda-510k.jpg K211562 - Virtue RF K211562 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: ShenB Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k211649/ 2021-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k211649-pcea-syringe-set-fda-510k.jpg K211649 - PCEA Syringe Set K211649 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corporation. Cleared Nov 2021. https://www.510kdatabase.net/k211765/ 2021-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k211765-cardinal-health-royalsilk-surgical-fda-510k.jpg K211765 - Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse Gown K211765 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cardinal Health, LLC. Cleared Nov 2021. https://www.510kdatabase.net/k211956/ 2021-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k211956-039-surgical-face-mask-fda-510k.jpg K211956 - 039 Surgical Face Mask K211956 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Aok Tooling Limited. Cleared Nov 2021. https://www.510kdatabase.net/k212101/ 2021-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k212101-da-vinci-sp-firefly-imaging-system-fda-510k.jpg K212101 - da Vinci SP Firefly Imaging System K212101 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k212150/ 2021-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k212150-exablate-prostate-system-fda-510k.jpg K212150 - Exablate Prostate System K212150 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: InSightec, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k212169/ 2021-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k212169-air-compression-therapy-system-fo3002-fda-510k.jpg K212169 - Air compression therapy system FO3002 K212169 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Foshan Hongfeng Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k212529/ 2021-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k212529-hypotension-decision-assist-model-hda-fda-510k.jpg K212529 - Hypotension Decision Assist Model HDA-OR2 K212529 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Directed Systems, Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k213184/ 2021-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k213184-mz-skin-lightmax-supercharged-led-mask-fda-510k.jpg K213184 - MZ Skin LightMAX Supercharged LED Mask 2.0 K213184 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Mz Skin. Cleared Nov 2021. https://www.510kdatabase.net/k213454/ 2021-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k213454-midas-rex-mr8-depth-stop-attachment-fda-510k.jpg K213454 - Midas Rex MR8 Depth Stop Attachment, Midas Rex MR8 Depth Stop Tool 2.4mm, Midas Rex MR8 Depth Stop Tool 3.2mm, Midas Rex MR8 Depth Stop Tool 3.2mm Long, Midas Rex MR8 Depth Stop Tool 7.5mm K213454 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Powered Surgical Solutions. Cleared Nov 2021. https://www.510kdatabase.net/den210012/ 2021-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/den210012-vpatch-fda-510k.jpg DEN210012 - vPatch DEN210012 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Virility Medical. Cleared Nov 2021. https://www.510kdatabase.net/k210265/ 2021-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k210265-vs3-iridium-sytem-fda-510k.jpg K210265 - VS3 Iridium Sytem K210265 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Visionsense, Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k210943/ 2021-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k210943-freestyle-libre-2-flash-glucose-fda-510k.jpg K210943 - FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) K210943 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Diabetes Care, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k210990/ 2021-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k210990-non-sterile-powder-free-nitrile-fda-510k.jpg K210990 - Non-sterile Powder Free Nitrile Examination Gloves K210990 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Rubberex Alliance Sdn Bhd. Cleared Nov 2021. https://www.510kdatabase.net/k211168/ 2021-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k211168-philips-incisive-ct-on-trailer-fda-510k.jpg K211168 - Philips Incisive CT on Trailer K211168 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Healthcare (Suzhou) Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k211651/ 2021-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k211651-eclipse-pro-fda-510k.jpg K211651 - Eclipse PRO K211651 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Spacelabs Healthcare, Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k211741/ 2021-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k211741-pre-formed-extra-support-guidewire-fda-510k.jpg K211741 - Pre-Formed Extra Support Guidewire K211741 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Lake Region Medical. Cleared Nov 2021. https://www.510kdatabase.net/k211854/ 2021-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k211854-vita-akzent-lc-fda-510k.jpg K211854 - VITA Akzent LC K211854 is a FDA 510(k) cleared dental medical device. Manufacturer: Vita Zahnfabrik GmbH H Rauter & CO. Cleared Nov 2021. https://www.510kdatabase.net/k211960/ 2021-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k211960-agile-esophageal-otw-stent-system-fda-510k.jpg K211960 - Agile Esophageal OTW Stent System K211960 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Nov 2021. https://www.510kdatabase.net/k212989/ 2021-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k212989-low-frequency-stimulator-model-ast-645-fda-510k.jpg K212989 - Low-frequency Stimulator (Model: AST-645, AST-646) K212989 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Osto Technology Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k213451/ 2021-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k213451-spartan-mc-0165-fda-510k.jpg K213451 - Spartan MC 0165 K213451 is a FDA 510(k) cleared neurology medical device. Manufacturer: Spartan Micro. Cleared Nov 2021. https://www.510kdatabase.net/k202288/ 2021-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k202288-finebeam-fda-510k.jpg K202288 - Finebeam K202288 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Snj Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k203074/ 2021-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k203074-disposable-latex-examination-gloves-fda-510k.jpg K203074 - Disposable Latex Examination Gloves (Non-Sterile), Disposable Nitrile Examination Gloves (Non-Sterile) K203074 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Pt. Universal Gloves. Cleared Nov 2021. https://www.510kdatabase.net/k210573/ 2021-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k210573-velofix-sa-cervical-cage-fda-510k.jpg K210573 - Velofix SA Cervical Cage K210573 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: U&I Corporation. Cleared Nov 2021. https://www.510kdatabase.net/k210831/ 2021-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k210831-onq-neuro-fda-510k.jpg K210831 - OnQ Neuro K210831 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cortechs Labs, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k211032/ 2021-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k211032-urinary-catheter-12-fr-urinary-fda-510k.jpg K211032 - Urinary Catheter 12 Fr, Urinary Catheter 16 Fr K211032 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Urogen Pharma, Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k211063/ 2021-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k211063-halyard-flexaprene-green-powder-free-fda-510k.jpg K211063 - HALYARD Flexaprene Green Powder-Free Exam Glove K211063 is a FDA 510(k) cleared general hospital medical device. Manufacturer: O&M Halyard, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k211080/ 2021-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k211080-ekosonic-endovascular-device-fda-510k.jpg K211080 - EkoSonic Endovascular Device K211080 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific. Cleared Nov 2021. https://www.510kdatabase.net/k211326/ 2021-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k211326-endoscreener-fda-510k.jpg K211326 - EndoScreener K211326 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Chengdu Wision Medical Device Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k212015/ 2021-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k212015-bd-nano-2nd-gen-pen-needle-fda-510k.jpg K212015 - BD Nano 2nd Gen Pen Needle K212015 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson and Company. Cleared Nov 2021. https://www.510kdatabase.net/k212653/ 2021-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k212653-catalyft-ls-expandable-interbody-system-fda-510k.jpg K212653 - Catalyft LS Expandable Interbody System K212653 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k212661/ 2021-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k212661-disposable-nitrile-examination-glove-fda-510k.jpg K212661 - Disposable Nitrile Examination Glove K212661 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Inner Mongolia Cureguard Medical Technology Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k212673/ 2021-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k212673-mr-5300-fda-510k.jpg K212673 - MR 5300 K212673 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Nov 2021. https://www.510kdatabase.net/k212697/ 2021-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k212697-leaf-smooth-fda-510k.jpg K212697 - Leaf Smooth K212697 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Leaflife Technology Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k213090/ 2021-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k213090-frontier-series-power-wheelchairs-fda-510k.jpg K213090 - Frontier Series Power Wheelchairs K213090 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Magic Mobility. Cleared Nov 2021. https://www.510kdatabase.net/k213213/ 2021-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k213213-arthrex-vortex-threaded-bone-marrow-fda-510k.jpg K213213 - Arthrex Vortex Threaded Bone Marrow Recovery Needle K213213 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Arthrex, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k213421/ 2021-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k213421-vector-hammertoe-correction-system-fda-510k.jpg K213421 - Vector® Hammertoe Correction System K213421 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nvision Biomedical Technologies, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k200091/ 2021-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k200091-capiox-icp-centrifugal-pump-fda-510k.jpg K200091 - Capiox iCP Centrifugal Pump K200091 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Cardiovascular Systems Corporation. Cleared Nov 2021. https://www.510kdatabase.net/k202087/ 2021-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k202087-dixi-medical-microdeep-micro-macro-fda-510k.jpg K202087 - DIXI Medical Microdeep Micro-Macro Depth Electrodes K202087 is a FDA 510(k) cleared neurology medical device. Manufacturer: Dixi Medical. Cleared Nov 2021. https://www.510kdatabase.net/k210350/ 2021-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k210350-gemini-2-810980-soft-tissue-laser-fda-510k.jpg K210350 - Gemini 2 810+980 Soft Tissue Laser K210350 is a FDA 510(k) cleared dental medical device. Manufacturer: Azena Medical, LLC. Cleared Nov 2021. https://www.510kdatabase.net/k211662/ 2021-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k211662-reprocessed-intellamap-orion-high-fda-510k.jpg K211662 - Reprocessed IntellaMap Orion High Resolution Mapping Catheter K211662 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Innovative Health, LLC. Cleared Nov 2021. https://www.510kdatabase.net/k211871/ 2021-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k211871-faico-dental-implant-system-and-cadcam-fda-510k.jpg K211871 - FAICO Dental Implant System and CAD/CAM Abutments K211871 is a FDA 510(k) cleared dental medical device. Manufacturer: Faico Medical, LLC. Cleared Nov 2021. https://www.510kdatabase.net/k211937/ 2021-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k211937-synecare-1100-deep-vein-thrombosis-fda-510k.jpg K211937 - SyneCare 1100 Deep Vein Thrombosis Prevention Therapy System K211937 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Jiangsu Synecoun Medical Technology Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k211998/ 2021-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k211998-desnuda-reflect-fda-510k.jpg K211998 - Desnuda Reflect K211998 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Good Clean Love, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k212000/ 2021-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k212000-medley-fda-510k.jpg K212000 - Medley K212000 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Good Clean Love, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k212046/ 2021-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k212046-impertech-surgical-face-mask-fda-510k.jpg K212046 - Impertech Surgical Face Mask K212046 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Impertech Industries , Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k212104/ 2021-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k212104-water-soluble-personal-lubricant-fda-510k.jpg K212104 - Water-soluble Personal Lubricant K212104 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Foshan Pingchuang Medical Technology Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k212112/ 2021-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k212112-cardiologs-holter-platform-fda-510k.jpg K212112 - Cardiologs Holter Platform K212112 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cardiologs Technologies. Cleared Nov 2021. https://www.510kdatabase.net/k212275/ 2021-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k212275-dermalux-flex-md-fda-510k.jpg K212275 - Dermalux Flex MD K212275 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesthetic Technology, Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k212487/ 2021-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k212487-colink-vallux-plating-system-fda-510k.jpg K212487 - CoLink Vallux Plating System K212487 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: In2bones USA, LLC. Cleared Nov 2021. https://www.510kdatabase.net/k212600/ 2021-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k212600-disposable-medical-nitrile-examination-fda-510k.jpg K212600 - Disposable Medical Nitrile Examination Gloves (Non-sterile) K212600 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Suqian Linglian Medical Technology Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k212640/ 2021-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k212640-stratum-ankle-fusion-plating-system-fda-510k.jpg K212640 - Stratum® Ankle Fusion Plating System K212640 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Nextremity Solutions, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k212992/ 2021-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k212992-link-embrace-shoulder-system-reverse-fda-510k.jpg K212992 - LINK® Embrace Shoulder System - Reverse Configuration K212992 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Waldemar Link GmbH & Co. KG. Cleared Nov 2021. https://www.510kdatabase.net/k213041/ 2021-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k213041-ipl-hair-removal-model-obt-02-fda-510k.jpg K213041 - IPL Hair Removal, Model: OBT-02 K213041 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Glan Electronics Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k213070/ 2021-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k213070-md-320w-ultrasound-biomicroscope-fda-510k.jpg K213070 - MD-320W Ultrasound Biomicroscope K213070 is a FDA 510(k) cleared radiology medical device. Manufacturer: MEDA Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k213251/ 2021-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k213251-hanarostent-esophagus-asymmetric-ccc-fda-510k.jpg K213251 - HANAROSTENT Esophagus Asymmetric (CCC) K213251 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: M.I. Tech Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k213406/ 2021-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k213406-savvy-mask-level-3-surgical-face-mask-fda-510k.jpg K213406 - Savvy Mask - Level 3 Surgical Face Mask K213406 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Texas Medplast, LLC. Cleared Nov 2021. https://www.510kdatabase.net/k213469/ 2021-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k213469-valory-fda-510k.jpg K213469 - VALORY K213469 is a FDA 510(k) cleared radiology medical device. Manufacturer: Agfa N.V.. Cleared Nov 2021. https://www.510kdatabase.net/k210042/ 2021-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k210042-disposable-surgical-mask-fda-510k.jpg K210042 - Disposable Surgical Mask K210042 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Suzhou Letian Protective Products Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k211538/ 2021-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k211538-protect-x-level-3-isolation-gown-fda-510k.jpg K211538 - Protect X Level 3 Isolation Gown K211538 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Azac Group. Cleared Nov 2021. https://www.510kdatabase.net/k211678/ 2021-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k211678-lunit-insight-mmg-fda-510k.jpg K211678 - Lunit INSIGHT MMG K211678 is a FDA 510(k) cleared radiology medical device. Manufacturer: Lunit, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k211890/ 2021-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k211890-promisemed-sharps-container-fda-510k.jpg K211890 - Promisemed Sharps container K211890 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Promisemed Hangzhou Meditech Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k212336/ 2021-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k212336-soteriaai-fda-510k.jpg K212336 - Soteria.AI K212336 is a FDA 510(k) cleared radiology medical device. Manufacturer: Omega Medical Imaging, LLC. Cleared Nov 2021. https://www.510kdatabase.net/k212415/ 2021-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k212415-arthrex-modular-glenoid-system-fda-510k.jpg K212415 - Arthrex Modular Glenoid System-Titanium Glenosphere K212415 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k212444/ 2021-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k212444-qora-stool-management-kit-fda-510k.jpg K212444 - Qora Stool Management Kit K212444 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cm Technologies, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k212456/ 2021-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k212456-swoop-point-of-care-magnetic-resonance-fda-510k.jpg K212456 - Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System K212456 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hyperfine, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k213425/ 2021-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k213425-bruxzir-esthetic-fda-510k.jpg K213425 - BruxZir Esthetic K213425 is a FDA 510(k) cleared dental medical device. Manufacturer: Prismatik Dentalcraft, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k210854/ 2021-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k210854-enteral-feeding-set-fda-510k.jpg K210854 - Enteral Feeding Set K210854 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Kb Medical (Group), Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k211286/ 2021-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k211286-ultipor-u55u55n-breathing-circuit-fda-510k.jpg K211286 - Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger K211286 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Pall Corporation. Cleared Nov 2021. https://www.510kdatabase.net/k211697/ 2021-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k211697-esperance-aspiration-catheter-system-fda-510k.jpg K211697 - Esperance Aspiration Catheter System K211697 is a FDA 510(k) cleared neurology medical device. Manufacturer: Wallaby Medical. Cleared Nov 2021. https://www.510kdatabase.net/k211845/ 2021-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k211845-deploy-expandable-interbody-system-fda-510k.jpg K211845 - Deploy Expandable Interbody System K211845 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Southern Spine, LLC. Cleared Nov 2021. https://www.510kdatabase.net/k212029/ 2021-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k212029-disposable-medical-nitrile-examination-fda-510k.jpg K212029 - Disposable Medical Nitrile Examination Gloves (non-sterile) K212029 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Taizhou Kangjian Medical Equipments Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k212047/ 2021-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k212047-pantheris-system-fda-510k.jpg K212047 - Pantheris System K212047 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Avinger, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k212265/ 2021-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k212265-tex20tex20-protex20stex20ttex20-fda-510k.jpg K212265 - TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System K212265 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k212344/ 2021-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k212344-surgical-mask-fda-510k.jpg K212344 - Surgical Mask K212344 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Xiantao Dingcheng Non-Woven Product Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k212455/ 2021-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k212455-inzone-detachment-system-fda-510k.jpg K212455 - InZone Detachment System K212455 is a FDA 510(k) cleared neurology medical device. Manufacturer: Stryker Neurovascular. Cleared Nov 2021. https://www.510kdatabase.net/k212839/ 2021-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k212839-opulent-tinbn-coated-knee-fda-510k.jpg K212839 - Opulent TiNbN Coated Knee K212839 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Meril Healthcare Pvt. , Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k212996/ 2021-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k212996-sterile-phalinx-hammertoe-system-fda-510k.jpg K212996 - Sterile PHALINX Hammertoe System K212996 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Nov 2021. https://www.510kdatabase.net/k213071/ 2021-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k213071-mototm-partial-knee-moto-pfj-systems-fda-510k.jpg K213071 - MOTOTM Partial Knee & MOTO PFJ Systems Extension K213071 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Nov 2021. https://www.510kdatabase.net/den210014/ 2021-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/den210014-easevrx-fda-510k.jpg DEN210014 - EaseVRx DEN210014 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Appliedvr, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k211329/ 2021-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k211329-sterile-disposable-syringe-with-saftey-fda-510k.jpg K211329 - Sterile Disposable Syringe with Saftey Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle K211329 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Kangbao Medical Equipment Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k211483/ 2021-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k211483-sofwave-system-fda-510k.jpg K211483 - SofWave System K211483 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sofwave Medical, Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k211754/ 2021-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k211754-vital-signs-monitor-fda-510k.jpg K211754 - Vital Signs Monitor K211754 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Beijing Choice Electronic Technology Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k212301/ 2021-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k212301-sonicision-7-curved-jaw-cordless-fda-510k.jpg K212301 - Sonicision 7 Curved Jaw Cordless Ultrasonic Dissection Device K212301 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien, LLC. Cleared Nov 2021. https://www.510kdatabase.net/k212607/ 2021-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k212607-darwin-fda-510k.jpg K212607 - Darwin K212607 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Luvo Medical Technologies, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k212695/ 2021-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k212695-karl-storz-icg-imaging-system-fda-510k.jpg K212695 - KARL STORZ ICG Imaging System K212695 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Karl Storz Endoscopy America. Cleared Nov 2021. https://www.510kdatabase.net/k212731/ 2021-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k212731-circul8-pro-fda-510k.jpg K212731 - Circul8 Pro K212731 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ortho8, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k212765/ 2021-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k212765-bloomden-dental-zirconia-blank-dental-fda-510k.jpg K212765 - Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank K212765 is a FDA 510(k) cleared dental medical device. Manufacturer: Bloomden Bioceramics (Hunan) Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k213000/ 2021-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k213000-air-compression-massager-model-lf-ft003-fda-510k.jpg K213000 - Air Compression Massager (Model LF-FT003) K213000 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Wenzhou Lingfeng Electronic Technology Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k213254/ 2021-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k213254-axialis-ophthalmic-ultrasound-system-fda-510k.jpg K213254 - Axialis Ophthalmic Ultrasound System K213254 is a FDA 510(k) cleared radiology medical device. Manufacturer: Quantel Medical. Cleared Nov 2021. https://www.510kdatabase.net/k213436/ 2021-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k213436-clarius-ultrasound-scanner-fda-510k.jpg K213436 - Clarius Ultrasound Scanner K213436 is a FDA 510(k) cleared radiology medical device. Manufacturer: Clarius Mobile Health Corp.. Cleared Nov 2021. https://www.510kdatabase.net/k213449/ 2021-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k213449-ds-implants-abutments-provided-with-fda-510k.jpg K213449 - DS Implants abutments provided with the EV connection K213449 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona. Cleared Nov 2021. https://www.510kdatabase.net/k213497/ 2021-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k213497-add-model-name-had1417mcw-add-model-fda-510k.jpg K213497 - ADD (Model Name: HAD1417MCW), ADD (Model Name: HAD1717MCW) K213497 is a FDA 510(k) cleared radiology medical device. Manufacturer: H&abyz Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k212109/ 2021-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k212109-spin-care-disposable-protective-mask-fda-510k.jpg K212109 - Spin Care Disposable Protective Mask Level 3 K212109 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Spintech, LLC. Cleared Nov 2021. https://www.510kdatabase.net/k212575/ 2021-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k212575-surgical-face-mask-fda-510k.jpg K212575 - Surgical Face Mask K212575 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hubei Huanfu Plastic Products Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k210785/ 2021-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k210785-disposable-surgical-gowns-fda-510k.jpg K210785 - Disposable Surgical Gowns K210785 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Chongqing Litai Fashion Group Limited Company. Cleared Nov 2021. https://www.510kdatabase.net/k212264/ 2021-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k212264-surgical-face-mask-fda-510k.jpg K212264 - Surgical Face mask K212264 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Nantong Taiweishi Medical Technology Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/den210006/ 2021-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/den210006-hemolung-respiratory-assist-system-fda-510k.jpg DEN210006 - Hemolung Respiratory Assist System DEN210006 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Alung Technologies, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k202319/ 2021-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k202319-insulin-pen-needle-ordinary-type-fda-510k.jpg K202319 - Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) K202319 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Tianjin Huahong Technology Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k202671/ 2021-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k202671-dr-hos-back-pain-relief-system-pro-fda-510k.jpg K202671 - DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II) K202671 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Guangzhou Xinbo Electronic Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k203184/ 2021-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k203184-hydrashift-24-isatuximab-fda-510k.jpg K203184 - HYDRASHIFT 2/4 isatuximab K203184 is a FDA 510(k) cleared immunology medical device. Manufacturer: Sebia. Cleared Nov 2021. https://www.510kdatabase.net/k210383/ 2021-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k210383-wrap-accessory-electrodes-fda-510k.jpg K210383 - Wrap Accessory Electrodes K210383 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Hi-Dow International, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k210757/ 2021-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k210757-etest-fosfomycin-fo-0032-512-gml-fda-510k.jpg K210757 - ETEST Fosfomycin (FO) (0.032-512 µg/mL) K210757 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Biomerieux S.A.. Cleared Nov 2021. https://www.510kdatabase.net/k210989/ 2021-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k210989-cirq-cirq-robotic-alignment-system-fda-510k.jpg K210989 - Cirq, Cirq Robotic Alignment System, Cirq Robotic Alignment Module Cranial, Cirq Robotic Alignment Module, Cirq Robotic Alignment Cranial And Spine, CIRQ Robotic Alignment Cranial and Spine System K210989 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Nov 2021. https://www.510kdatabase.net/k211359/ 2021-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k211359-tornier-perform-patient-matched-fda-510k.jpg K211359 - Tornier Perform™ Patient-Matched Primary Reversed Glenoid and BLUEPRINT™ Patient Specific Instrumentation K211359 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tornier, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k211876/ 2021-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k211876-intellijoint-view-fda-510k.jpg K211876 - Intellijoint VIEW K211876 is a FDA 510(k) cleared radiology medical device. Manufacturer: Intellijoint Surgical, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k212259/ 2021-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k212259-zirdent-dental-zirconia-blank-dental-fda-510k.jpg K212259 - Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank K212259 is a FDA 510(k) cleared dental medical device. Manufacturer: Zirdent New Material Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k212448/ 2021-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k212448-nightguard-flex-fda-510k.jpg K212448 - NightGuard Flex K212448 is a FDA 510(k) cleared dental medical device. Manufacturer: Sprintray, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k212595/ 2021-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k212595-erchonia-fx-405-fda-510k.jpg K212595 - Erchonia FX-405 K212595 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Erchonia Corporation. Cleared Nov 2021. https://www.510kdatabase.net/k212621/ 2021-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k212621-mammovista-bsmart-fda-510k.jpg K212621 - MAMMOVISTA B.smart K212621 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k212984/ 2021-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k212984-mipacs-html5-web-viewer-fda-510k.jpg K212984 - MiPACS HTML5 Web Viewer K212984 is a FDA 510(k) cleared radiology medical device. Manufacturer: Lead Technologies, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k212497/ 2021-11-11 monthly 0.5 https://www.510kdatabase.net/og-image/k212497-nitrile-examination-glove-powder-free-fda-510k.jpg K212497 - Nitrile Examination Glove (Powder free, Blue) K212497 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Jinlian Medical Technology Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k212532/ 2021-11-11 monthly 0.5 https://www.510kdatabase.net/og-image/k212532-disposable-powder-free-nitrile-exam-fda-510k.jpg K212532 - Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs) K212532 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Crdlight Optoelectronic Technology Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k213364/ 2021-11-11 monthly 0.5 https://www.510kdatabase.net/og-image/k213364-ensite-x-ep-system-fda-510k.jpg K213364 - EnSite X EP System K213364 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared Nov 2021. https://www.510kdatabase.net/k201082/ 2021-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k201082-ltv2-series-ventilators-fda-510k.jpg K201082 - LTV2 Series Ventilators K201082 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Vyaire Medical, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k203746/ 2021-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k203746-venen-trainer-model-fm150-sfm90-fda-510k.jpg K203746 - Venen-trainer (Model: FM150, SFM90) K203746 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Pango Electronic Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k210344/ 2021-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k210344-invisionos-fda-510k.jpg K210344 - inVisionOS K210344 is a FDA 510(k) cleared radiology medical device. Manufacturer: Precisionos Technology, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k210779/ 2021-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k210779-powder-free-nitrile-patient-fda-510k.jpg K210779 - Powder Free Nitrile Patient Examination Gloves, Blue Color K210779 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shandong Shangwei Medical Products Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k211244/ 2021-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k211244-vsp-orthopedics-system-fda-510k.jpg K211244 - VSP® Orthopedics System K211244 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 3D Systems. Cleared Nov 2021. https://www.510kdatabase.net/k211733/ 2021-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k211733-lunit-insight-cxr-triage-fda-510k.jpg K211733 - Lunit INSIGHT CXR Triage K211733 is a FDA 510(k) cleared radiology medical device. Manufacturer: Lunit, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k211975/ 2021-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k211975-desara-tv-ez-30-system-desara-blue-tv-fda-510k.jpg K211975 - Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara Blue TV EZ 2.7 System K211975 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Caldera Medical, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k212003/ 2021-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k212003-essenz-patient-monitor-fda-510k.jpg K212003 - ESSENZ Patient Monitor K212003 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Livanova Deutschland, GmbH. Cleared Nov 2021. https://www.510kdatabase.net/k212013/ 2021-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k212013-ekuore-pro-4t-ref-ep0098-fda-510k.jpg K212013 - eKuore Pro 4T - REF EP0098 K212013 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Chip Ideas Electronics S.L.. Cleared Nov 2021. https://www.510kdatabase.net/k212107/ 2021-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k212107-reverso-fda-510k.jpg K212107 - Reverso K212107 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intelis Instruments , Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k212284/ 2021-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k212284-disposable-automatic-core-biopsy-fda-510k.jpg K212284 - Disposable Automatic Core Biopsy Instrument K212284 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Suzhou Leapmed Healthcare Corporation. Cleared Nov 2021. https://www.510kdatabase.net/k212583/ 2021-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k212583-alignrt-plus-fda-510k.jpg K212583 - AlignRT Plus K212583 is a FDA 510(k) cleared radiology medical device. Manufacturer: Vision Rt, Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k212659/ 2021-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k212659-more-cell-system-fda-510k.jpg K212659 - More-Cell-System K212659 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Agency For Medical Innovations GmbH. Cleared Nov 2021. https://www.510kdatabase.net/k212887/ 2021-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k212887-rtapp-fda-510k.jpg K212887 - RTapp K212887 is a FDA 510(k) cleared radiology medical device. Manufacturer: Segana, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k212978/ 2021-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k212978-diode-laser-therapy-system-fda-510k.jpg K212978 - Diode laser therapy system K212978 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Beijing Unt Technology Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k213089/ 2021-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k213089-ivenix-infusion-system-lvp-epidural-fda-510k.jpg K213089 - Ivenix Infusion System, LVP Epidural Administraion Set NRFit Connector K213089 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ivenix, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k213389/ 2021-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k213389-identity-imprint-cruciate-retaining-cr-fda-510k.jpg K213389 - Identity Imprint Cruciate Retaining (CR) Knee Replacement System and Identity Imprint Posterior Stabilized (PS) Knee Replacement System K213389 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Conformis, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k202326/ 2021-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k202326-bespa-charcot-system-fda-510k.jpg K202326 - BESPA Charcot System K202326 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Bespa Global, LLC. Cleared Nov 2021. https://www.510kdatabase.net/k211165/ 2021-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k211165-medical-face-masks-model-namemy020003-fda-510k.jpg K211165 - Medical Face Masks, Model Name:MY020003 K211165 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Huizhou Jie Bai Purification Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k211206/ 2021-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k211206-freedomedger-syringe-infusion-system-fda-510k.jpg K211206 - FreedomEdge(R) Syringe Infusion System K211206 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Repro-Medical System, Inc., Dba Koru Medical Systems. Cleared Nov 2021. https://www.510kdatabase.net/k211289/ 2021-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k211289-rmu-2000-automated-chest-compression-fda-510k.jpg K211289 - RMU-2000 Automated Chest Compression System K211289 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Defibtech, LLC. Cleared Nov 2021. https://www.510kdatabase.net/k211315/ 2021-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k211315-comby-eeg-caps-fda-510k.jpg K211315 - Comby EEG Caps K211315 is a FDA 510(k) cleared neurology medical device. Manufacturer: Pamel D.O.O. Cleared Nov 2021. https://www.510kdatabase.net/k211517/ 2021-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k211517-optica-xt-thulium-fiber-laser-and-fda-510k.jpg K211517 - Optica XT Thulium Fiber Laser and Accessories, also known as Optica XT, Optica XT Thulium Fiber Laser, Thulium Fiber Laser 1940 nm, Optica XT Thulium Fiber Laser 1940 nm, Optica XT 60 Thulium Fiber Laser 1940 nm, Optica XT Superpulse Thulium Fiber Laser 1940 nm, OptiLITE Laser Fibers and Accessories K211517 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Convergent Laser Technologies. Cleared Nov 2021. https://www.510kdatabase.net/k211546/ 2021-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k211546-vektor-computational-ecg-mapping-fda-510k.jpg K211546 - Vektor Computational ECG Mapping System (vMap) K211546 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vektor Medical, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k211967/ 2021-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k211967-sensual-massage-ultra-pure-fda-510k.jpg K211967 - Sensual Massage, Ultra Pure K211967 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Dreambrands, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k212331/ 2021-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k212331-bodysculp-fda-510k.jpg K212331 - BodySculp K212331 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Rohrer Aesthetics, LLC. Cleared Nov 2021. https://www.510kdatabase.net/k212526/ 2021-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k212526-surgical-face-mask-fda-510k.jpg K212526 - Surgical Face Mask K212526 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Suzhou Janee Medical Technology Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k213383/ 2021-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k213383-whill-model-c2-fda-510k.jpg K213383 - WHILL Model C2 K213383 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Whill, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k202371/ 2021-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k202371-highspeed-airturbine-handpiece-fda-510k.jpg K202371 - Highspeed Airturbine Handpiece K202371 is a FDA 510(k) cleared dental medical device. Manufacturer: Beijing Dongbo Dental Handpiece Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k203067/ 2021-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k203067-quantum-perfusion-single-lumen-cannula-fda-510k.jpg K203067 - Quantum Perfusion Single Lumen Cannula 22F, Quantum Perfusion Dual Lumen Cannula 31F, Quantum Perfusion Dual Lumen Cannula 27F, Quantum Perfusion Dual Lumen Cannula 24F K203067 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Qura S.R.L. Cleared Nov 2021. https://www.510kdatabase.net/k211199/ 2021-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k211199-st-aia-pack-bnp-assay-fda-510k.jpg K211199 - ST AIA-PACK BNP Assay K211199 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Tosoh Bioscience, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k211356/ 2021-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k211356-giquant-fda-510k.jpg K211356 - GIQuant K211356 is a FDA 510(k) cleared radiology medical device. Manufacturer: Motilent, Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k212068/ 2021-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k212068-biotech-dental-kits-fda-510k.jpg K212068 - Biotech Dental Kits K212068 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Biotech Dental, Sas. Cleared Nov 2021. https://www.510kdatabase.net/k212550/ 2021-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k212550-hura-ctp-v10-fda-510k.jpg K212550 - Hura CTP v1.0 K212550 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hura Imaging, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k212787/ 2021-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k212787-gt5-conductive-abrasive-gel-fda-510k.jpg K212787 - GT5 conductive & abrasive gel K212787 is a FDA 510(k) cleared neurology medical device. Manufacturer: Wuhan Greentek Pty , Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k212895/ 2021-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k212895-paragon-28-external-ring-fixation-system-fda-510k.jpg K212895 - Paragon 28 External Ring Fixation System K212895 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paragon 28, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k212956/ 2021-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k212956-fdr-cross-dr-xd-3000-fda-510k.jpg K212956 - FDR Cross (DR-XD 3000) K212956 is a FDA 510(k) cleared radiology medical device. Manufacturer: Fujifilm Corporation. Cleared Nov 2021. https://www.510kdatabase.net/k212504/ 2021-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k212504-isolation-gown-aami-level-3-fda-510k.jpg K212504 - Isolation Gown AAMI Level 3 K212504 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Kenpax International Limited. Cleared Nov 2021. https://www.510kdatabase.net/k212506/ 2021-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k212506-medical-examination-gloves-tested-for-fda-510k.jpg K212506 - Medical Examination Gloves (Tested for Use with Chemotherapy) K212506 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guangdong Gymda Medical Technology Co.,Ltd. Cleared Nov 2021. https://www.510kdatabase.net/k202110/ 2021-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k202110-mstim-drop-model-lgt-233-fda-510k.jpg K202110 - MStim Drop Model: LGT-233 K202110 is a FDA 510(k) cleared neurology medical device. Manufacturer: Guangzhou Longest Science & Technology Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k202676/ 2021-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k202676-disposable-medical-face-mask-fda-510k.jpg K202676 - Disposable Medical Face Mask K202676 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zhejiang Senhong Medical&Instrument Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k210253/ 2021-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k210253-best-glove-latex-powder-free-fda-510k.jpg K210253 - Best Glove-Latex Powder Free Examination Glove K210253 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bestsafe Glove Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k210859/ 2021-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k210859-nextar-spine-platform-fda-510k.jpg K210859 - NextAR™ Spine Platform K210859 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Nov 2021. https://www.510kdatabase.net/k211055/ 2021-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k211055-microcurrent-device-model-hbr2-1-fda-510k.jpg K211055 - Microcurrent device (Model: HBR2-1) K211055 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen DJ Medical Equipment Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k211577/ 2021-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k211577-softfix-balloon-trocar-fda-510k.jpg K211577 - SoftFix Balloon Trocar K211577 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Unimax Medical Systems, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k211726/ 2021-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k211726-acuson-sc2000-diagnostic-ultrasound-fda-510k.jpg K211726 - Acuson SC2000 Diagnostic Ultrasound System K211726 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k211817/ 2021-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k211817-anterion-fda-510k.jpg K211817 - Anterion K211817 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Heidelberg Engineering GmbH. Cleared Nov 2021. https://www.510kdatabase.net/k211971/ 2021-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k211971-drug-relief-v1-fda-510k.jpg K211971 - Drug Relief v1 K211971 is a FDA 510(k) cleared neurology medical device. Manufacturer: Dyansys, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k212044/ 2021-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k212044-truelok-evo-fda-510k.jpg K212044 - TrueLok Evo K212044 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthofix Srl. Cleared Nov 2021. https://www.510kdatabase.net/k212460/ 2021-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k212460-medical-surgical-mask-model-zkm-u01non-fda-510k.jpg K212460 - Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm)) K212460 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guangzhou Zhengkang Medical Equipment Co.,Ltd. Cleared Nov 2021. https://www.510kdatabase.net/k212485/ 2021-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k212485-disposable-nitrile-examination-gloves-fda-510k.jpg K212485 - Disposable Nitrile Examination gloves K212485 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Fujian Yuanxin Safety Protection Technology Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k212502/ 2021-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k212502-resonic-rapid-acoustic-pulse-device-fda-510k.jpg K212502 - Resonic Rapid Acoustic Pulse Device K212502 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Soliton, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k212523/ 2021-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k212523-vfss-pro-mobile-digital-imaging-system-fda-510k.jpg K212523 - VFSS Pro Mobile Digital Imaging System K212523 is a FDA 510(k) cleared radiology medical device. Manufacturer: Imagexray, LLC. Cleared Nov 2021. https://www.510kdatabase.net/k212551/ 2021-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k212551-nitrile-examination-gloves-fda-510k.jpg K212551 - Nitrile Examination Gloves K212551 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Anhui Fine Glove Medical Technology Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k212707/ 2021-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k212707-coolsculpting-elite-system-fda-510k.jpg K212707 - CoolSculpting Elite System K212707 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Zeltiq Aesthetics, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k212853/ 2021-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k212853-cervical-stand-alone-system-fda-510k.jpg K212853 - Cervical Stand-Alone System K212853 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Eminent Spine, LLC. Cleared Nov 2021. https://www.510kdatabase.net/k212896/ 2021-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k212896-visible-patient-suite-fda-510k.jpg K212896 - Visible Patient Suite K212896 is a FDA 510(k) cleared radiology medical device. Manufacturer: Visible Patient, Sas. Cleared Nov 2021. https://www.510kdatabase.net/k212900/ 2021-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k212900-mx7mx7tvaus7zeusme7anesus-me7anesus-fda-510k.jpg K212900 - MX7/MX7T/Vaus7/Zeus/ME7/Anesus ME7/Anesus ME7T/MX8/MX8T/Vaus8/ME8 Diagnostic Ultrasound System K212900 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k210384/ 2021-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k210384-carescape-r860-fda-510k.jpg K210384 - CARESCAPE R860 K210384 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Datex-Ohmeda, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k210628/ 2021-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k210628-x-flo-fluid-management-system-fda-510k.jpg K210628 - X-FLO Fluid Management System K210628 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Thermedx, LLC. Cleared Nov 2021. https://www.510kdatabase.net/k211103/ 2021-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k211103-powder-free-vinyl-examination-gloves-fda-510k.jpg K211103 - Powder Free Vinyl Examination Gloves K211103 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shanghai Shengda Medical Applications Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k211288/ 2021-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k211288-microlife-wrist-watch-blood-pressure-fda-510k.jpg K211288 - Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B K211288 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Microlife Intellectual Property GmbH. Cleared Nov 2021. https://www.510kdatabase.net/k211729/ 2021-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k211729-comprehensive-convertible-glenoid-fda-510k.jpg K211729 - Comprehensive® Convertible Glenoid - Vivacit-E Liner K211729 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet Manufacturing Corp. Cleared Nov 2021. https://www.510kdatabase.net/k212019/ 2021-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k212019-blood-collection-needle-for-single-use-fda-510k.jpg K212019 - Blood Collection Needle for Single Use & Blood Collection Needle with Holder for Single Use, Safety Blood Collection Needle for Single Use, Safety Blood Collection Needle with Holder for Single Use, Blood Collection Set for Single Use & Safety Blood Collection Set with Holder for Single Use, Safety Blood Collection Set for Single Use & Blood Collection Set with Holder for Single K212019 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Micsafe Medical Technology Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k212467/ 2021-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k212467-disposable-nitrile-examination-glove-fda-510k.jpg K212467 - Disposable Nitrile Examination Glove K212467 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Inner Mongolia Boming Medical Supplies Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k212471/ 2021-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k212471-medical-face-mask-fda-510k.jpg K212471 - Medical Face Mask K212471 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Haian Medigauze Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k212496/ 2021-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k212496-ortho-aligner-system-fda-510k.jpg K212496 - Ortho Aligner System K212496 is a FDA 510(k) cleared dental medical device. Manufacturer: Ortho Lab Services, LLC. Cleared Nov 2021. https://www.510kdatabase.net/k212510/ 2021-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k212510-7-series-phototherapy-device-fda-510k.jpg K212510 - 7 Series Phototherapy Device K212510 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Daavlin Distributing Co.. Cleared Nov 2021. https://www.510kdatabase.net/k212511/ 2021-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k212511-1688-4k-camera-control-unit-with-fda-510k.jpg K212511 - 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K Autoclave Camera Head, C-Mount (1688410105), AIM 4K Autoclave Coupler, C-Mount (1688410110) K212511 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker. Cleared Nov 2021. https://www.510kdatabase.net/k212897/ 2021-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k212897-ipl-hair-removal-device-model-ai01-fda-510k.jpg K212897 - IPL Hair Removal Device, model: AI01 K212897 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Century Dongyuan Technology CO , Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k212912/ 2021-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k212912-onefix-biocomposite-anchors-onefix-fda-510k.jpg K212912 - OneFix Biocomposite Anchors, OneFix Biocomposite Small Anchors, OneFix All Suture Anchors, OneFix Interference Screws, OneFix Cannula System K212912 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: B-One Ortho, Corp.. Cleared Nov 2021. https://www.510kdatabase.net/k212937/ 2021-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k212937-dakota-alif-plate-system-fda-510k.jpg K212937 - Dakota ALIF Plate System K212937 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Precision Spine, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k191964/ 2021-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k191964-bd-kiestra-identifa-fda-510k.jpg K191964 - BD Kiestra IdentifA K191964 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson and Company. Cleared Nov 2021. https://www.510kdatabase.net/k201320/ 2021-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k201320-quantum-pureflow-centrifugal-blood-fda-510k.jpg K201320 - Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor K201320 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Qura S.R.L. Cleared Nov 2021. https://www.510kdatabase.net/k202732/ 2021-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k202732-sol-care-iv-bag-safety-connector-fda-510k.jpg K202732 - SOL-CARE IV Bag Safety Connector K202732 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sol-Millennium Medical Group. Cleared Nov 2021. https://www.510kdatabase.net/k203372/ 2021-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k203372-symri-fda-510k.jpg K203372 - SyMRI K203372 is a FDA 510(k) cleared radiology medical device. Manufacturer: Syntheticmr AB. Cleared Nov 2021. https://www.510kdatabase.net/k210432/ 2021-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k210432-leltek-ultrasound-imaging-system-model-fda-510k.jpg K210432 - LELTEK Ultrasound Imaging System (Model: LU700 Series) K210432 is a FDA 510(k) cleared radiology medical device. Manufacturer: Leltek, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k210543/ 2021-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k210543-im007-fda-510k.jpg K210543 - IM007 K210543 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Implicity, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k210969/ 2021-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k210969-nulife-fda-510k.jpg K210969 - Nulife K210969 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Mrk Healthcare Pvt, Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k211544/ 2021-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k211544-trajectory-planning-elements-fda-510k.jpg K211544 - Trajectory Planning, Elements Trajectory Planning, Elements Lead Localization K211544 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Nov 2021. https://www.510kdatabase.net/k211947/ 2021-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k211947-glidescope-bflex-28-single-use-fda-510k.jpg K211947 - GlideScope BFlex 2.8 Single-Use Bronchoscope K211947 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Verathon Medical (Canada) Ulc. Cleared Nov 2021. https://www.510kdatabase.net/k212084/ 2021-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k212084-fetal-doppler-fda-510k.jpg K212084 - Fetal Doppler K212084 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shenzhen Mericonn Technology Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k212151/ 2021-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k212151-flume-catheter-fda-510k.jpg K212151 - FLUME catheter K212151 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: The Flume Catheter Company, Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k212199/ 2021-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k212199-asap-aspiration-catheter-asaplp-fda-510k.jpg K212199 - ASAP Aspiration Catheter, ASAPLP Aspiration Catheter K212199 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k212404/ 2021-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k212404-sin-instrument-kits-fda-510k.jpg K212404 - S.I.N. Instrument Kits K212404 is a FDA 510(k) cleared general hospital medical device. Manufacturer: S.I.N. ? Sistema DE Implante Nacional S.A.. Cleared Nov 2021. https://www.510kdatabase.net/k212446/ 2021-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k212446-nuvasive-anterior-cervical-plate-systems-fda-510k.jpg K212446 - NuVasive Anterior Cervical Plate Systems K212446 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Nov 2021. https://www.510kdatabase.net/k212515/ 2021-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k212515-movix-dreamy-fda-510k.jpg K212515 - MOVIX DReamy K212515 is a FDA 510(k) cleared radiology medical device. Manufacturer: Stephanix. Cleared Nov 2021. https://www.510kdatabase.net/k212537/ 2021-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k212537-real-intelligence-cori-cori-fda-510k.jpg K212537 - REAL INTELLIGENCE CORI (CORI) K212537 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Blue Belt Technologies, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/den200040/ 2021-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/den200040-omnigene-gut-dx-fda-510k.jpg DEN200040 - OMNIgene GUT Dx DEN200040 is a FDA 510(k) cleared microbiology medical device. Manufacturer: DNA Genotek, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k210222/ 2021-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k210222-disposable-medical-mask-fda-510k.jpg K210222 - Disposable Medical Mask K210222 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guangdong Lide Medical Technology Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k210473/ 2021-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k210473-nova-glass-cements-nova-glass-l-nova-fda-510k.jpg K210473 - Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus) K210473 is a FDA 510(k) cleared dental medical device. Manufacturer: Imicryl Dis Malzemeleri Sanayi VE Ticaret AS. Cleared Nov 2021. https://www.510kdatabase.net/k210598/ 2021-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k210598-pediatric-nasogastric-feeding-tubes-fda-510k.jpg K210598 - Pediatric Nasogastric Feeding Tubes - Single ENFit Port K210598 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cair Lgl. Cleared Nov 2021. https://www.510kdatabase.net/k210777/ 2021-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k210777-powder-free-nitrile-patient-fda-510k.jpg K210777 - Powder Free Nitrile Patient Examination Gloves, Blue Color K210777 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shandong Jieshi Medical Products Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k210921/ 2021-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k210921-taichib-fda-510k.jpg K210921 - TaiChiB K210921 is a FDA 510(k) cleared radiology medical device. Manufacturer: Our United Corporation. Cleared Nov 2021. https://www.510kdatabase.net/k212306/ 2021-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k212306-tapestry-biointegrative-implant-fda-510k.jpg K212306 - Tapestry Biointegrative Implant K212306 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Embody, Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k213326/ 2021-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k213326-visionx-30-fda-510k.jpg K213326 - VisionX 3.0 K213326 is a FDA 510(k) cleared radiology medical device. Manufacturer: Durr Dental SE. Cleared Nov 2021. https://www.510kdatabase.net/k210499/ 2021-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k210499-alpha-dent-implants-dental-implants-fda-510k.jpg K210499 - Alpha Dent Implants Dental Implants System K210499 is a FDA 510(k) cleared dental medical device. Manufacturer: Alpha Dent Implants GmbH. Cleared Nov 2021. https://www.510kdatabase.net/k211079/ 2021-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k211079-biofire-covid-19-test-2-fda-510k.jpg K211079 - BioFire COVID-19 Test 2 K211079 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Biofire Defense, LLC. Cleared Nov 2021. https://www.510kdatabase.net/k211586/ 2021-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k211586-nitrile-examination-gloves-blue-violet-fda-510k.jpg K211586 - Nitrile Examination Gloves (Blue, Violet) K211586 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Lyncmed Medical Technology (Beijing) Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k212171/ 2021-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k212171-electronic-blood-pressure-monitor-fda-510k.jpg K212171 - Electronic Blood Pressure Monitor K212171 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Dongguan Kangweile Electronic Technology Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k212338/ 2021-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k212338-sterileright-sterilization-pouch-and-fda-510k.jpg K212338 - SterileRight sterilization pouch and roll K212338 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sterileright Packaging Mfg., Inc.. Cleared Nov 2021. https://www.510kdatabase.net/k212823/ 2021-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k212823-depuy-conduit-llif-angled-inserters-fda-510k.jpg K212823 - DePuy CONDUIT LLIF Angled Inserters K212823 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Enztec Limited. Cleared Nov 2021. https://www.510kdatabase.net/k212948/ 2021-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k212948-pain-therapy-devicemodel-dh-pts-i-dh-fda-510k.jpg K212948 - Pain Therapy Device(Model: DH-P.T.S-I, DH-P.T.S-II, DH-P.T.S-IIA, DH-P.T.S-IIB, DH-CP-I) K212948 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Guangzhou Xinbo Electronic Co., Ltd.. Cleared Nov 2021. https://www.510kdatabase.net/k210588/ 2021-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k210588-black-nitrile-powder-free-patient-fda-510k.jpg K210588 - Black Nitrile Powder Free Patient Examination Glove, Non Sterile K210588 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Onetexx Sdn Bhd. Cleared Oct 2021. https://www.510kdatabase.net/k212403/ 2021-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k212403-tracheal-stent-system-y-shaped-fda-510k.jpg K212403 - Tracheal Stent System (Y-Shaped) K212403 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Micro-Tech (Nanjing) Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k201032/ 2021-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k201032-phoenix-digital-thermometer-fda-510k.jpg K201032 - Phoenix Digital Thermometer K201032 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k201496/ 2021-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k201496-n-latex-flc-kappa-n-latex-flc-lambda-fda-510k.jpg K201496 - N Latex FLC kappa, N Latex FLC lambda K201496 is a FDA 510(k) cleared immunology medical device. Manufacturer: Siemens Healthcare Diagnostics Products GmbH. Cleared Oct 2021. https://www.510kdatabase.net/k210279/ 2021-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k210279-enbio-s-fda-510k.jpg K210279 - Enbio S K210279 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Enbio Group AG. Cleared Oct 2021. https://www.510kdatabase.net/k210570/ 2021-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k210570-traumaguard-intra-abdominal-pressure-fda-510k.jpg K210570 - TraumaGuard Intra-abdominal Pressure Sensing System K210570 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sentinel Medical Technologies, LLC. Cleared Oct 2021. https://www.510kdatabase.net/k211064/ 2021-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k211064-nview-s1-with-nav-option-fda-510k.jpg K211064 - nView s1 with nav option K211064 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nview Medical. Cleared Oct 2021. https://www.510kdatabase.net/k211161/ 2021-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k211161-critical-care-suite-with-endotracheal-fda-510k.jpg K211161 - Critical Care Suite with Endotracheal Tube Positing AI algorithm K211161 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems, LLC. Cleared Oct 2021. https://www.510kdatabase.net/k211987/ 2021-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k211987-atec-alignment-app-fda-510k.jpg K211987 - ATEC Alignment App K211987 is a FDA 510(k) cleared radiology medical device. Manufacturer: Alphatec Spine, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k212308/ 2021-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k212308-shark-gloves-blue-nitrile-examination-fda-510k.jpg K212308 - SHARK GLOVES Blue Nitrile Examination Gloves Powder Free, INCONGLOVE Blue Nitrile Examination Gloves Powder Free K212308 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Srirungruang Global Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k212389/ 2021-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k212389-advantage-lumbar-system-alif-plif-dlif-fda-510k.jpg K212389 - Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF K212389 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Intelivation, LLC. Cleared Oct 2021. https://www.510kdatabase.net/k212831/ 2021-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k212831-mectalif-extension-fda-510k.jpg K212831 - MectaLIF Extension K212831 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Oct 2021. https://www.510kdatabase.net/k213163/ 2021-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k213163-versawrap-fda-510k.jpg K213163 - VersaWrap K213163 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Alafair Biosciences, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k213195/ 2021-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k213195-balloon-bs-3-fda-510k.jpg K213195 - Balloon BS-3 K213195 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fujifilm Corporation. Cleared Oct 2021. https://www.510kdatabase.net/k213264/ 2021-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k213264-carto-3-ep-navigation-system-version-72-fda-510k.jpg K213264 - CARTO 3 EP Navigation System Version 7.2 K213264 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biosense Webster, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k213351/ 2021-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k213351-ds-head-32ch-30t-fda-510k.jpg K213351 - ds Head 32ch 3.0T K213351 is a FDA 510(k) cleared radiology medical device. Manufacturer: Invivo Corporation (Business Trade Name: Philips). Cleared Oct 2021. https://www.510kdatabase.net/k200839/ 2021-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k200839-apas-independence-with-ic-chromogenic-fda-510k.jpg K200839 - APAS Independence with IC Chromogenic MRSA BD Analysis Module K200839 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Clever Culture Systems. Cleared Oct 2021. https://www.510kdatabase.net/k210287/ 2021-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k210287-vitek-2-ast-streptococcus-cefotaxime-fda-510k.jpg K210287 - VITEK 2 AST- Streptococcus Cefotaxime (<=0.125 - =>8 ug/mL) K210287 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k211019/ 2021-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k211019-disposable-monopolar-laparoscopic-tips-fda-510k.jpg K211019 - Disposable Monopolar Laparoscopic Tips and Reusable Handles K211019 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Dannik, LLC. Cleared Oct 2021. https://www.510kdatabase.net/k211160/ 2021-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k211160-endotool-subq-21-fda-510k.jpg K211160 - EndoTool SubQ 2.1 K211160 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Monarch Medical Technologies, LLC. Cleared Oct 2021. https://www.510kdatabase.net/k211581/ 2021-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k211581-disposable-nitrile-examination-gloves-fda-510k.jpg K211581 - Disposable Nitrile Examination Gloves (Powder free, Blue) K211581 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Leping Shengde Medical Technology Company Limited. Cleared Oct 2021. https://www.510kdatabase.net/k211797/ 2021-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k211797-tracker-plus-kyphoplasty-system-fda-510k.jpg K211797 - TRACKER Plus Kyphoplasty System K211797 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: GS Medical Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k212290/ 2021-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k212290-examination-gloves-type-c-nitrile-gloves-fda-510k.jpg K212290 - Examination gloves -Type C (Nitrile gloves) K212290 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangxi Kemei Medical Apparatus & Instruments Group Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k212424/ 2021-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k212424-amsco-400-small-steam-sterilizers-fda-510k.jpg K212424 - AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers K212424 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Oct 2021. https://www.510kdatabase.net/k212489/ 2021-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k212489-bonos-inject-bone-cement-fda-510k.jpg K212489 - BonOs Inject Bone Cement K212489 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Neo Medical SA. Cleared Oct 2021. https://www.510kdatabase.net/k201520/ 2021-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k201520-the-alma-opus-system-colibri-fda-510k.jpg K201520 - The Alma Opus System, Colibri Applicator and Tips K201520 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Alma Lasers, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k203316/ 2021-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k203316-vaculta-negative-pressure-wound-fda-510k.jpg K203316 - V.A.C.ULTA Negative Pressure Wound Therapy System K203316 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Kci, A Part of 3M Health Care Business Group. Cleared Oct 2021. https://www.510kdatabase.net/k210873/ 2021-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k210873-thermo-scientific-oxoid-lefamulin-disc-fda-510k.jpg K210873 - Thermo Scientific Oxoid Lefamulin Disc (20µg) LMU20 K210873 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Oxoid Limited (Part of Thermo Fisher Scientific). Cleared Oct 2021. https://www.510kdatabase.net/k211604/ 2021-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k211604-powder-free-nitrile-examination-gloves-fda-510k.jpg K211604 - Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs K211604 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shanxi Hongjin Plastic Technology Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k213125/ 2021-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k213125-peri-strips-dry-staple-line-fda-510k.jpg K213125 - PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology K213125 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Synovis Life Technologies. Inc. (A Subsidiary of Baxter. Cleared Oct 2021. https://www.510kdatabase.net/k213153/ 2021-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k213153-spiway-endonasal-access-guide-fda-510k.jpg K213153 - SPIWay Endonasal Access Guide K213153 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Spiway, LLC. Cleared Oct 2021. https://www.510kdatabase.net/k202998/ 2021-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k202998-vydence-zye-and-vydence-one-fda-510k.jpg K202998 - Vydence Zye and Vydence One K202998 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Vydence Medical Industria E Comercio Ltda. Cleared Oct 2021. https://www.510kdatabase.net/k211069/ 2021-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k211069-endsnorz-sleep-appliance-fda-510k.jpg K211069 - EndSnorZ Sleep Appliance K211069 is a FDA 510(k) cleared dental medical device. Manufacturer: Prismatik Dentalcraft, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k211537/ 2021-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k211537-quickaligners-fda-510k.jpg K211537 - QuickAligners K211537 is a FDA 510(k) cleared dental medical device. Manufacturer: Oral Image, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k211977/ 2021-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k211977-medical-diode-laser-systems-fda-510k.jpg K211977 - Medical Diode Laser Systems K211977 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wuhan Dimed Laser Technology Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k212363/ 2021-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k212363-disposable-medical-nitrile-examination-fda-510k.jpg K212363 - Disposable Medical Nitrile Examination Gloves K212363 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Lanhuo Medical Technology (Jiangsu) Co.,Ltd. Cleared Oct 2021. https://www.510kdatabase.net/k213081/ 2021-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k213081-clisis-systems-discovery-rf180-fda-510k.jpg K213081 - CLISIS SYSTEMS, Discovery RF180 K213081 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Medical Merate S.P.A. Cleared Oct 2021. https://www.510kdatabase.net/k213124/ 2021-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k213124-tomier-perform-reversed-glenoid-fda-510k.jpg K213124 - Tomier Perform™ Reversed Glenoid Cannulated Glenospheres K213124 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tornier, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k213164/ 2021-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k213164-avaira-vitality-fda-510k.jpg K213164 - Avaira Vitality K213164 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: CooperVision, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k213166/ 2021-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k213166-thrombuster-ii-aspiration-catheter-fda-510k.jpg K213166 - Thrombuster II Aspiration Catheter K213166 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Kaneka Medical America, LLC. Cleared Oct 2021. https://www.510kdatabase.net/k210249/ 2021-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k210249-best-glove-nitrile-powder-free-fda-510k.jpg K210249 - Best Glove-Nitrile Powder Free Examination Glove K210249 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bestsafe Glove Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k210488/ 2021-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k210488-ultrasonic-surgical-electrosurgical-fda-510k.jpg K210488 - Ultrasonic Surgical & Electrosurgical Generator K210488 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k212146/ 2021-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k212146-arthrex-looploc-knotless-suture-fda-510k.jpg K212146 - Arthrex LoopLoc Knotless Suture K212146 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Arthrex, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k212218/ 2021-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k212218-advanced-algorithms-for-treatment-fda-510k.jpg K212218 - Advanced Algorithms for Treatment Management Applications (AATMA) K212218 is a FDA 510(k) cleared radiology medical device. Manufacturer: Elekta Solutions AB. Cleared Oct 2021. https://www.510kdatabase.net/k212293/ 2021-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k212293-surgical-mask-model-wk1701-02a-wk1701-fda-510k.jpg K212293 - Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A) K212293 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangmen Ningrui Medical Supplies Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k212401/ 2021-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k212401-disposable-nitrile-examination-glove-fda-510k.jpg K212401 - Disposable Nitrile Examination Glove K212401 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Inner Mongolia Cureguard Medical Technology Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k212793/ 2021-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k212793-laser-treatment-system-model-hera-armo-fda-510k.jpg K212793 - Laser Treatment System, Model: Hera, Armo K212793 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Canadian Pioneer Medical Technology Corporation. Cleared Oct 2021. https://www.510kdatabase.net/k213085/ 2021-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k213085-introcan-safety-3-closed-iv-catheter-fda-510k.jpg K213085 - Introcan Safety 3 Closed IV Catheter K213085 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k213386/ 2021-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k213386-titan-manufacturing-bipolar-forceps-fda-510k.jpg K213386 - Titan Manufacturing Bipolar Forceps K213386 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Titan Manufacturing, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k210348/ 2021-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k210348-disposable-medical-surgical-mask-fda-510k.jpg K210348 - Disposable Medical Surgical Mask K210348 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Weihai Dishang Medical Technology Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k211509/ 2021-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k211509-surgical-gown-fda-510k.jpg K211509 - Surgical Gown K211509 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hubei Wanli Protective Products Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k211698/ 2021-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k211698-vinyl-examination-glovesyellow-fda-510k.jpg K211698 - Vinyl Examination Gloves(Yellow) K211698 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Liuping Trading Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k212368/ 2021-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k212368-surgical-face-mask-fda-510k.jpg K212368 - Surgical Face Mask K212368 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Anhui Tiankang Medical Technology Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k202120/ 2021-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k202120-p300-attachment-fda-510k.jpg K202120 - P300 Attachment K202120 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nakanishi, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k210310/ 2021-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k210310-cryodose-v-5050-175ml-canister-kit-fda-510k.jpg K210310 - CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit K210310 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Nuance Medical, LLC. Cleared Oct 2021. https://www.510kdatabase.net/k210424/ 2021-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k210424-quantum-anterior-cervical-plate-fda-510k.jpg K210424 - Quantum Anterior Cervical Plate K210424 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nvision Biomedical Technologies, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k210807/ 2021-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k210807-flightplan-for-liver-fda-510k.jpg K210807 - FlightPlan for Liver K210807 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems SCS. Cleared Oct 2021. https://www.510kdatabase.net/k211186/ 2021-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k211186-erchonia-xlr8-fda-510k.jpg K211186 - Erchonia XLR8 K211186 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Erchonia Corporation. Cleared Oct 2021. https://www.510kdatabase.net/k211735/ 2021-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k211735-co2-laser-machine-model-bw-203b-fda-510k.jpg K211735 - CO2 Laser Machine, Model: BW-203B K211735 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Zhengzhou Bestview ST Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k211775/ 2021-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k211775-cohitech-organic-cotton-non-applicator-fda-510k.jpg K211775 - Cohitech Organic Cotton Non-Applicator Cottonlock Tampons K211775 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Cotton High Tech S.L.. Cleared Oct 2021. https://www.510kdatabase.net/k211819/ 2021-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k211819-dilumen-c2-and-tool-mount-fda-510k.jpg K211819 - DiLumen C2 and Tool Mount K211819 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Lumendi, LLC. Cleared Oct 2021. https://www.510kdatabase.net/k212061/ 2021-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k212061-ensite-x-ep-system-fda-510k.jpg K212061 - EnSite X EP System K212061 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott. Cleared Oct 2021. https://www.510kdatabase.net/k212193/ 2021-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k212193-terragene-bionova-scbi-bt96-terragene-fda-510k.jpg K212193 - Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) K212193 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Plasmapp Co,., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k212198/ 2021-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k212198-tyvekr-roll-with-ci-for-sterlinktm-fda-510k.jpg K212198 - Tyvek(R) Roll with CI for STERLINKTM Sterilizer K212198 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Plasmapp Co,., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k212200/ 2021-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k212200-sterlinktm-fps-15s-plus-sterilizer-fda-510k.jpg K212200 - STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette K212200 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Plasmapp Co,., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k212396/ 2021-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k212396-urolift-system-rigid-retrieval-kit-fda-510k.jpg K212396 - UroLift System Rigid Retrieval Kit Sterilization Tray K212396 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Neotract, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k212399/ 2021-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k212399-aveli-fda-510k.jpg K212399 - Aveli K212399 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Nc8, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k212516/ 2021-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k212516-irnf-app-fda-510k.jpg K212516 - IRNF App K212516 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Apple, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k212666/ 2021-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k212666-neuromark-system-fda-510k.jpg K212666 - Neuromark System K212666 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Neurent Medical. Cleared Oct 2021. https://www.510kdatabase.net/k200545/ 2021-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k200545-legend-pro-dma-fda-510k.jpg K200545 - Legend Pro DMA K200545 is a FDA 510(k) cleared neurology medical device. Manufacturer: Pollogen, Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k210322/ 2021-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k210322-xo-cross-support-catheter-fda-510k.jpg K210322 - XO Cross Support Catheter K210322 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Transit Scientific, LLC. Cleared Oct 2021. https://www.510kdatabase.net/k210928/ 2021-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k210928-pentax-medical-video-bronchoscope-eb11-fda-510k.jpg K210928 - PENTAX Medical Video Bronchoscope EB11-J10 K210928 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Pentax of America, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k211171/ 2021-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k211171-carescape-respiratory-modules-e-sco-e-fda-510k.jpg K211171 - CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX, E-sCAiOE, E-sCAiOVE and accessories K211171 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: GE Healthcare Finland Oy. Cleared Oct 2021. https://www.510kdatabase.net/k211407/ 2021-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k211407-belun-ring-blr-100x-fda-510k.jpg K211407 - Belun Ring BLR-100X K211407 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Belun Technology Company Limited. Cleared Oct 2021. https://www.510kdatabase.net/k211415/ 2021-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k211415-gr-splint-resin-system-fda-510k.jpg K211415 - GR Splint Resin System K211415 is a FDA 510(k) cleared dental medical device. Manufacturer: Pro3dure Medical GmbH. Cleared Oct 2021. https://www.510kdatabase.net/k211526/ 2021-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k211526-portable-scalp-cooling-system-fda-510k.jpg K211526 - Portable Scalp Cooling System K211526 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cooler Heads Care, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k212270/ 2021-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k212270-deka-lipoai-fda-510k.jpg K212270 - DEKA LipoAI K212270 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: El.En Electronic Engineering Spa. Cleared Oct 2021. https://www.510kdatabase.net/k212311/ 2021-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k212311-medical-examination-gloves-fda-510k.jpg K212311 - Medical Examination Gloves K212311 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guangzhou Junda Gloves Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k212314/ 2021-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k212314-ipl-hair-removal-device-fda-510k.jpg K212314 - IPL Hair Removal Device K212314 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Zhongshan Bisen Plastic Electronic Products Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k213028/ 2021-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k213028-tenax-laser-resistant-endotracheal-tube-fda-510k.jpg K213028 - Tenax Laser Resistant Endotracheal Tube K213028 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Bryan Medical, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k213036/ 2021-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k213036-treace-medical-concepts-tmc-screw-fda-510k.jpg K213036 - Treace Medical Concepts (TMC) Screw Fixation System K213036 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Treace Medical Concepts, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k213113/ 2021-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k213113-orthoscan-tau-mini-c-arm-fda-510k.jpg K213113 - Orthoscan Tau Mini C-Arm K213113 is a FDA 510(k) cleared radiology medical device. Manufacturer: Orthoscan, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k200865/ 2021-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k200865-piccolo-potassium-test-system-fda-510k.jpg K200865 - Piccolo Potassium Test System K200865 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abaxis, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k203808/ 2021-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k203808-multi-unit-abutment-multi-unit-angled-fda-510k.jpg K203808 - Multi-unit Abutment, Multi-unit Angled Abutment K203808 is a FDA 510(k) cleared dental medical device. Manufacturer: Megagen Implant Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k210177/ 2021-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k210177-pentax-medical-video-upper-gi-scopes-fda-510k.jpg K210177 - PENTAX Medical Video Upper GI Scopes EG17-J10 K210177 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Pentax of America, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k210511/ 2021-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k210511-intray-gc-fda-510k.jpg K210511 - InTray GC K210511 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Biomed Diagnostics Incorporated. Cleared Oct 2021. https://www.510kdatabase.net/k210618/ 2021-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k210618-beamer-aveo-irrigation-pump-endolinq-fda-510k.jpg K210618 - Beamer Aveo Irrigation Pump, Endolinq Endoscopic Irrigation Pump, Endoscopic Irrigation Pump Series K210618 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Chongqing Jinshan Science & Technology Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k210632/ 2021-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k210632-contour-protegeai-fda-510k.jpg K210632 - Contour ProtegeAI K210632 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mim Software, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k210789/ 2021-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k210789-eq-pex-fda-510k.jpg K210789 - EQ-PEX K210789 is a FDA 510(k) cleared dental medical device. Manufacturer: Meta Systems Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k211672/ 2021-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k211672-mts-piperacillin-tazobactam-00164-fda-510k.jpg K211672 - MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL K211672 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Liofilchem S. R. L.. Cleared Oct 2021. https://www.510kdatabase.net/k211921/ 2021-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k211921-sin-dental-implant-system-fda-510k.jpg K211921 - S.I.N. Dental Implant System K211921 is a FDA 510(k) cleared dental medical device. Manufacturer: S.I.N. ? Sistema DE Implante Nacional S.A.. Cleared Oct 2021. https://www.510kdatabase.net/k212427/ 2021-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k212427-cobas-cdiff-nucleic-acid-test-for-use-fda-510k.jpg K212427 - cobas Cdiff nucleic acid test for use on the cobas Liat System K212427 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Molecular Systems, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k212470/ 2021-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k212470-irad-fda-510k.jpg K212470 - iRAD K212470 is a FDA 510(k) cleared radiology medical device. Manufacturer: Claritas Healthtech Pte, Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k212490/ 2021-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k212490-avvigo-guidance-system-ii-fda-510k.jpg K212490 - AVVIGO Guidance System II K212490 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Oct 2021. https://www.510kdatabase.net/den210005/ 2021-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/den210005-luminopia-one-fda-510k.jpg DEN210005 - Luminopia One DEN210005 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Luminopia, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k192746/ 2021-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k192746-myoworx-tm20-fda-510k.jpg K192746 - MyoWorx TM20 K192746 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Myoworx, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k201773/ 2021-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k201773-picohi-fda-510k.jpg K201773 - PICOHI K201773 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Hironic Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k202982/ 2021-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k202982-silver-alginate-dressing-prescription-fda-510k.jpg K202982 - Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use) K202982 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Winner Medical Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k203565/ 2021-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k203565-surgical-3d-mask-fda-510k.jpg K203565 - Surgical 3D Mask K203565 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Inno Lifecare. Cleared Oct 2021. https://www.510kdatabase.net/k210124/ 2021-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k210124-synergy-gold-sg-portable-models-fda-510k.jpg K210124 - Synergy Gold (SG) Portable (Models MM011450 and MM011460) K210124 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Uzinmedicare Co.. Cleared Oct 2021. https://www.510kdatabase.net/k210204/ 2021-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k210204-capsule-vitals-plus-patient-monitoring-fda-510k.jpg K210204 - Capsule Vitals Plus Patient Monitoring System K210204 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Capsule Technologie Sas. Cleared Oct 2021. https://www.510kdatabase.net/k210706/ 2021-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k210706-nitrile-examination-gloves-fda-510k.jpg K210706 - Nitrile Examination Gloves K210706 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Niujian Technology Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k210911/ 2021-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k210911-wolf-thrombectomy-system-14f-fda-510k.jpg K210911 - WOLF Thrombectomy System, 14F K210911 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Devoro Medical, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k211035/ 2021-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k211035-u9000-plus-ultrafilter-fda-510k.jpg K211035 - U9000 Plus Ultrafilter K211035 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corporation. Cleared Oct 2021. https://www.510kdatabase.net/k211084/ 2021-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k211084-aneroid-sphygmomanometer-aneroid-fda-510k.jpg K211084 - Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscope K211084 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shanghai Caremate Medical Device Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k211170/ 2021-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k211170-single-use-irrigation-bipolar-cable-fda-510k.jpg K211170 - Single Use Irrigation bipolar cable K211170 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Modern Medical Equipment Manufacturing, Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k211564/ 2021-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k211564-sterile-high-pressure-angiographic-fda-510k.jpg K211564 - Sterile High-pressure Angiographic Syringes for Single-use K211564 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen Boon Medical Supply Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k212254/ 2021-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k212254-dentria-series-dentria-dentri-ca-fda-510k.jpg K212254 - DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa) K212254 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hdx Will Corp.. Cleared Oct 2021. https://www.510kdatabase.net/k212703/ 2021-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k212703-acupulse-co2-laser-system-delivery-fda-510k.jpg K212703 - AcuPulse CO2 Laser System, Delivery Devices and Accessories K212703 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lumenis, Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k193613/ 2021-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k193613-allergen-specific-ige-assay-12-fda-510k.jpg K193613 - Allergen-Specific IgE Assay 12 Allergen Bundle K193613 is a FDA 510(k) cleared immunology medical device. Manufacturer: Hitachi Chemical Diagnostics, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k201017/ 2021-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k201017-bd-max-vaginal-panel-bd-max-system-bd-fda-510k.jpg K201017 - BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit K201017 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Geneohm Sciences Canada, Inc. (Bd Life Sciences). Cleared Oct 2021. https://www.510kdatabase.net/k211555/ 2021-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k211555-hypodermic-safety-needle-fda-510k.jpg K211555 - Hypodermic Safety Needle K211555 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k211582/ 2021-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k211582-loqteq-proximal-humerus-plate-35-system-fda-510k.jpg K211582 - LOQTEQ Proximal Humerus Plate 3.5 System K211582 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aap Implantate AG. Cleared Oct 2021. https://www.510kdatabase.net/k211809/ 2021-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k211809-surgical-gown-fda-510k.jpg K211809 - Surgical Gown K211809 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wuhan Dymex Healthcare Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k212528/ 2021-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k212528-change-healthcare-cardiology-fda-510k.jpg K212528 - Change Healthcare Cardiology K212528 is a FDA 510(k) cleared radiology medical device. Manufacturer: Change Healthcare Israel , Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k212632/ 2021-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k212632-clottriever-thrombectomy-system-fda-510k.jpg K212632 - ClotTriever Thrombectomy System K212632 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inari Medical, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k212753/ 2021-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k212753-0909fcb-1212fca-fda-510k.jpg K212753 - 0909FCB, 1212FCA K212753 is a FDA 510(k) cleared radiology medical device. Manufacturer: Rayence Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k201880/ 2021-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k201880-multisure-gk-link-blood-glucose-and-fda-510k.jpg K201880 - MultiSure GK Link Blood Glucose and Ketone Monitoring System K201880 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Apex BioTechnology Corp.. Cleared Oct 2021. https://www.510kdatabase.net/k202433/ 2021-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k202433-aqueduct-200-cervical-dilation-balloon-fda-510k.jpg K202433 - Aqueduct 200 Cervical Dilation Balloon Catheter K202433 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Gtimd, LLC. Cleared Oct 2021. https://www.510kdatabase.net/k210563/ 2021-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k210563-arm-blood-pressure-monitor-fda-510k.jpg K210563 - Arm Blood Pressure Monitor K210563 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Alicn Medical (Shenzhen), Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k211091/ 2021-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k211091-deka-tiac-ii-fda-510k.jpg K211091 - Deka Tiac II K211091 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: El.En Electronic Engineering Spa. Cleared Oct 2021. https://www.510kdatabase.net/k211224/ 2021-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k211224-rm4-control-unit-fda-510k.jpg K211224 - RM4 Control Unit K211224 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Institut Georges Lopez. Cleared Oct 2021. https://www.510kdatabase.net/k211403/ 2021-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k211403-hivox-otc-electrical-stimulator-ft610-b-fda-510k.jpg K211403 - HIVOX OTC Electrical Stimulator, FT610-B K211403 is a FDA 510(k) cleared neurology medical device. Manufacturer: Hivox Biotek, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k211992/ 2021-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k211992-ortho-mi-system-fda-510k.jpg K211992 - Ortho MI System K211992 is a FDA 510(k) cleared dental medical device. Manufacturer: Osteonic Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k212517/ 2021-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k212517-magicore-system-fda-510k.jpg K212517 - Magicore System K212517 is a FDA 510(k) cleared dental medical device. Manufacturer: Innobiosurg Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k212593/ 2021-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k212593-viacath-acqrate-dx-steerable-catheter-fda-510k.jpg K212593 - ViaCath, AcQRate Dx Steerable Catheter K212593 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biotronick, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k212636/ 2021-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k212636-corus-spinal-system-x-fda-510k.jpg K212636 - CORUS Spinal System-X K212636 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Providence Medical Technology, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k212959/ 2021-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k212959-acuson-acunav-volume-intracardiac-fda-510k.jpg K212959 - ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter K212959 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k212967/ 2021-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k212967-axtiha-stand-alone-alif-system-fda-510k.jpg K212967 - AxTiHA Stand-Alone ALIF System K212967 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Innovasis, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k202688/ 2021-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k202688-afs-medical-sterile-single-use-access-fda-510k.jpg K202688 - AFS Medical Sterile Single-Use Access Port System K202688 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Afs Medical Co. , Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k202808/ 2021-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k202808-brainance-md-fda-510k.jpg K202808 - Brainance MD K202808 is a FDA 510(k) cleared radiology medical device. Manufacturer: Advantis Medical Imaging Single Member P.C.. Cleared Oct 2021. https://www.510kdatabase.net/k210231/ 2021-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k210231-vittra-aps-unique-fda-510k.jpg K210231 - Vittra APS Unique K210231 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentscare Ltda. Cleared Oct 2021. https://www.510kdatabase.net/k210999/ 2021-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k210999-swiftmr-fda-510k.jpg K210999 - SwiftMR K210999 is a FDA 510(k) cleared radiology medical device. Manufacturer: Airs Medical, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k211121/ 2021-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k211121-intera-non-coring-huber-refill-needles-fda-510k.jpg K211121 - Intera Non-coring (Huber) Refill Needles, Intera Non-coring (Huber) Special bolus Needles and OR Prep Kit K211121 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Intera Oncology, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k211147/ 2021-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k211147-algo-7i-fda-510k.jpg K211147 - ALGO 7i K211147 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Path Medical GmbH. Cleared Oct 2021. https://www.510kdatabase.net/k211214/ 2021-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k211214-sterile-hypodermic-needles-for-single-fda-510k.jpg K211214 - Sterile Hypodermic Needles for Single Use K211214 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Azur Medical Company, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k211461/ 2021-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k211461-family-of-venus-rf-systems-venus-freedom-fda-510k.jpg K211461 - Family of Venus RF Systems - Venus Freedom K211461 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Venus Concept USA, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k211753/ 2021-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k211753-sterile-syringe-with-safety-needle-fda-510k.jpg K211753 - Sterile Syringe With Safety Needle K211753 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangxi Hongda Medical Equipment Group , Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k211807/ 2021-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k211807-sapphire-nc-24-fda-510k.jpg K211807 - Sapphire NC 24 K211807 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: OrbusNeich Medical (Shenzhen) Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k211914/ 2021-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k211914-nitrile-patient-examination-gloves-fda-510k.jpg K211914 - Nitrile Patient Examination Gloves K211914 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Yingxiang Glove Products Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k212205/ 2021-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k212205-medical-protective-masks-fda-510k.jpg K212205 - Medical Protective Masks K212205 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Qinhuangdao Taizhi Medical Technology Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k212261/ 2021-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k212261-strokesens-lvo-fda-510k.jpg K212261 - StrokeSENS LVO K212261 is a FDA 510(k) cleared radiology medical device. Manufacturer: Circle Neurovascular Imaging, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k213002/ 2021-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k213002-scorpion-portal-vein-access-set-fda-510k.jpg K213002 - SCORPION Portal Vein Access Set K213002 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Argon Medical Devices. Cleared Oct 2021. https://www.510kdatabase.net/k210116/ 2021-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k210116-video-endoscopy-system-3d-video-fda-510k.jpg K210116 - Video Endoscopy System, 3D Video Endoscopy System K210116 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k211374/ 2021-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k211374-proclean-nitrile-powder-free-fda-510k.jpg K211374 - Proclean - Nitrile Powder Free Examination Gloves K211374 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Dr.Boo Company Limited. Cleared Oct 2021. https://www.510kdatabase.net/k211801/ 2021-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k211801-sprint-pns-system-fda-510k.jpg K211801 - SPRINT PNS System K211801 is a FDA 510(k) cleared neurology medical device. Manufacturer: Spr Therapeutics, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k211905/ 2021-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k211905-ultracal-xs-fda-510k.jpg K211905 - UltraCal XS K211905 is a FDA 510(k) cleared dental medical device. Manufacturer: Ultradent Products, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k212014/ 2021-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k212014-medical-nitrile-examination-gloves-fda-510k.jpg K212014 - Medical Nitrile Examination Gloves K212014 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangxi Ronglai Medical Technology Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k212544/ 2021-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k212544-miniload-syringe-fda-510k.jpg K212544 - MiniLoad Syringe K212544 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ocuject, LLC. Cleared Oct 2021. https://www.510kdatabase.net/k212825/ 2021-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k212825-corelink-navigation-instruments-fda-510k.jpg K212825 - CoreLink Navigation Instruments K212825 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corelink, LLC. Cleared Oct 2021. https://www.510kdatabase.net/k212908/ 2021-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k212908-embotrap-ii-revascularization-device-fda-510k.jpg K212908 - EmboTrap II Revascularization Device, EMBOTRAP III Revascularization Device K212908 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neuravi, Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k210845/ 2021-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k210845-disposable-surgical-mask-model-yykz-01-fda-510k.jpg K210845 - Disposable Surgical Mask (Model: YYKZ-01) K210845 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiaxing Amazing Travel-Ware Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k211927/ 2021-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k211927-nitrile-examination-gloves-fda-510k.jpg K211927 - Nitrile examination gloves K211927 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Fitone Latex Products Co., Ltd. Guangdong. Cleared Oct 2021. https://www.510kdatabase.net/k212116/ 2021-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k212116-vbrain-oar-fda-510k.jpg K212116 - VBrain-OAR K212116 is a FDA 510(k) cleared radiology medical device. Manufacturer: Vysioneer, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k212307/ 2021-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k212307-bc-reflex-uni-knee-system-fda-510k.jpg K212307 - BC Reflex Uni Knee System K212307 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Bodycad Laboratories, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k212552/ 2021-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k212552-correx-software-fda-510k.jpg K212552 - Correx Software K212552 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Vilex, LLC. Cleared Oct 2021. https://www.510kdatabase.net/k212560/ 2021-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k212560-signature-one-system-fda-510k.jpg K212560 - Signature™ ONE System K212560 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthosoft Inc. (d/b/a) Zimmer CAS. Cleared Oct 2021. https://www.510kdatabase.net/k212562/ 2021-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k212562-idys-c-zp-3dti-fda-510k.jpg K212562 - Idys-C ZP 3DTi K212562 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Clariance, SA. Cleared Oct 2021. https://www.510kdatabase.net/k201514/ 2021-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k201514-child-face-mask-fda-510k.jpg K201514 - Child Face Mask K201514 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shandong Shengquan New Material Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k203750/ 2021-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k203750-straumann-cares-p-series-cadcam-system-fda-510k.jpg K203750 - Straumann CARES P-Series CAD/CAM System K203750 is a FDA 510(k) cleared dental medical device. Manufacturer: Institut Straumann AG. Cleared Oct 2021. https://www.510kdatabase.net/k212174/ 2021-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k212174-sterrad-100nx-sterilizer-with-allclear-fda-510k.jpg K212174 - STERRAD 100NX Sterilizer with ALLClear Technology K212174 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Advanced Sterilization Products, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k201210/ 2021-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k201210-the-micro-screw-system-micro-screw-fda-510k.jpg K201210 - The Micro Screw System, Micro Screw System Basic K201210 is a FDA 510(k) cleared dental medical device. Manufacturer: Hager& Meisinger GmbH. Cleared Oct 2021. https://www.510kdatabase.net/k201989/ 2021-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k201989-b4c-system-fda-510k.jpg K201989 - B4C System K201989 is a FDA 510(k) cleared neurology medical device. Manufacturer: Braincare Desenvolvimento E Inovacao Tecnologica S.A.. Cleared Oct 2021. https://www.510kdatabase.net/k203497/ 2021-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k203497-infrared-thermometer-model-k9-fda-510k.jpg K203497 - Infrared Thermometer (Model K9) K203497 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Kangzhan Communication Electronics Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k203688/ 2021-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k203688-clear-aligner-fda-510k.jpg K203688 - Clear Aligner K203688 is a FDA 510(k) cleared dental medical device. Manufacturer: Wuxi EA Medical Instruments Technologies Limited.. Cleared Oct 2021. https://www.510kdatabase.net/k210128/ 2021-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k210128-integra-wound-matrix-macro-channels-fda-510k.jpg K210128 - INTEGRA Wound Matrix (Macro-Channels) K210128 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Integra LifeSciences Corporation. Cleared Oct 2021. https://www.510kdatabase.net/k210211/ 2021-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k210211-purastat-om-fda-510k.jpg K210211 - PuraStat-OM K210211 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3-D Matrix, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k210622/ 2021-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k210622-single-use-medical-face-mask-fda-510k.jpg K210622 - Single-Use Medical Face Mask K210622 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangxi Hongda Medical Equipment Group Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k210813/ 2021-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k210813-medical-surgical-mask-fda-510k.jpg K210813 - Medical Surgical Mask K210813 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sichuan Pharmaceutical., Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k211680/ 2021-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k211680-streamline-surgical-system-fda-510k.jpg K211680 - Streamline Surgical System K211680 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: New World Medical, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k211706/ 2021-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k211706-esophageal-tts-stent-fda-510k.jpg K211706 - Esophageal TTS Stent K211706 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Taewoong Medical Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k212078/ 2021-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k212078-medical-examination-gloves-fda-510k.jpg K212078 - Medical Examination Gloves K212078 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guangdong Gymda Medical Technology Co.,Ltd. Cleared Oct 2021. https://www.510kdatabase.net/k212156/ 2021-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k212156-abccolla-bone-matrix-fda-510k.jpg K212156 - ABCcolla Bone Matrix K212156 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Acro Biomedical Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k212479/ 2021-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k212479-cohitech-reusable-tampon-applicator-fda-510k.jpg K212479 - Cohitech Reusable Tampon Applicator K212479 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Cotton High Tech S.L.. Cleared Oct 2021. https://www.510kdatabase.net/k212520/ 2021-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k212520-prolift-micro-expandable-spacer-system-fda-510k.jpg K212520 - ProLift Micro Expandable Spacer System K212520 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k212876/ 2021-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k212876-carescape-spo2-masimo-fda-510k.jpg K212876 - Carescape SpO2 - Masimo K212876 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Masimo Corporation. Cleared Oct 2021. https://www.510kdatabase.net/k210024/ 2021-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k210024-neomatrix-wound-matrix-fda-510k.jpg K210024 - NeoMatriX Wound Matrix K210024 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Nextgen Biologics, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k210376/ 2021-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k210376-superior-hair-remover-fda-510k.jpg K210376 - Superior Hair Remover K210376 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Guangzhou Haoxingwan Technology Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k210906/ 2021-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k210906-intellivue-patient-monitor-mx750-fda-510k.jpg K210906 - IntelliVue Patient Monitor MX750, IntelliVue Patient Monitor MX850, IntelliVue 4-Slot module rack FMX-4 K210906 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Philips Medizin Systeme Boeblingen GmbH. Cleared Oct 2021. https://www.510kdatabase.net/k211077/ 2021-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k211077-surgical-gown-fda-510k.jpg K211077 - Surgical Gown K211077 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wujiang Tutaike Textiles & Finishing Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k211211/ 2021-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k211211-sterile-syringes-for-single-use-fda-510k.jpg K211211 - Sterile syringes for single use with/without needle K211211 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Azur Medical Company, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k211406/ 2021-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k211406-oasis-mri-system-fda-510k.jpg K211406 - OASIS MRI System K211406 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hitachi Healthcare Americas. Cleared Oct 2021. https://www.510kdatabase.net/k212065/ 2021-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k212065-vascuchek-kit-vascuchek-transceiver-fda-510k.jpg K212065 - VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger K212065 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Remington Medical, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k212279/ 2021-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k212279-digital-intraoral-x-ray-imaging-system-fda-510k.jpg K212279 - Digital Intraoral X-ray Imaging System K212279 is a FDA 510(k) cleared radiology medical device. Manufacturer: Iray Technology Taicang , Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k212860/ 2021-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k212860-smartband-emr-kit-sb-emr-k-sb-emr-k-12-fda-510k.jpg K212860 - SmartBand EMR Kit (SB-EMR-K, SB-EMR-K-12, SB-EMR-K-9.4), SmartBand EMR Pack (SB-EMR-P, SB-EMR-P-12, SB-EMR-P-9.4), SmartSnare EMR Hexagonal Snare (SS-230-1 or packaged with kit) K212860 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: STERIS Corporation. Cleared Oct 2021. https://www.510kdatabase.net/k202063/ 2021-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k202063-trusfil-universal-composite-restorative-fda-510k.jpg K202063 - TrusFIL Universal Composite Restorative K202063 is a FDA 510(k) cleared dental medical device. Manufacturer: Rizhao Huge Biomaterials Company, Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k211621/ 2021-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k211621-latex-surgical-gloves-powder-free-with-fda-510k.jpg K211621 - Latex Surgical Gloves, Powder Free with Protein claim (50 micrograms or less) K211621 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Careplus (M) Sdn Bhd. Cleared Oct 2021. https://www.510kdatabase.net/k211719/ 2021-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k211719-zinrom-nitrile-examination-gloves-fda-510k.jpg K211719 - ZinRom Nitrile examination gloves K211719 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Changzhou Xingrong Medical Technology Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k212082/ 2021-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k212082-picore-fda-510k.jpg K212082 - Picore K212082 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bio-Med USA, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k212191/ 2021-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k212191-adhesive-electrodes-fda-510k.jpg K212191 - Adhesive Electrodes K212191 is a FDA 510(k) cleared neurology medical device. Manufacturer: Voncare Medical Device Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k212739/ 2021-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k212739-actiflip-fda-510k.jpg K212739 - ActiFlip K212739 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Parcus Medical, LLC. Cleared Oct 2021. https://www.510kdatabase.net/k212835/ 2021-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k212835-aquabeam-robotic-system-fda-510k.jpg K212835 - AquaBeam Robotic System K212835 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Procept Biorobotics, Corporation. Cleared Oct 2021. https://www.510kdatabase.net/k201394/ 2021-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k201394-caresens-n-feliz-blood-glucose-fda-510k.jpg K201394 - CareSens N Feliz Blood Glucose Monitoring System, CareSens N Feliz BT Blood Glucose Monitoring System K201394 is a FDA 510(k) cleared chemistry medical device. Manufacturer: I-Sens, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k201456/ 2021-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k201456-scan-monitor-fda-510k.jpg K201456 - Scan Monitor K201456 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Withings SA. Cleared Oct 2021. https://www.510kdatabase.net/k203002/ 2021-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k203002-salgina-25mm-volar-distal-radius-fda-510k.jpg K203002 - SALGINA 2.5mm Volar Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, TAMlNA 3.5mm Proximal Humerus System, TRIFT 3.5mm 1/3 Tubular System K203002 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Bonebridge AG. Cleared Oct 2021. https://www.510kdatabase.net/k203288/ 2021-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k203288-cala-trio-fda-510k.jpg K203288 - Cala Trio K203288 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cala Health, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k210406/ 2021-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k210406-bipolar-coagulation-foreceps-fda-510k.jpg K210406 - Bipolar Coagulation Foreceps K210406 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hangzhou AGS MedTech Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k210490/ 2021-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k210490-chm-45mm-cortical-screws-fda-510k.jpg K210490 - ChM 4.5mm Cortical screws K210490 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Chm Sp. Z O.O.. Cleared Oct 2021. https://www.510kdatabase.net/k211429/ 2021-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k211429-naviplan-ct-planning-software-for-fda-510k.jpg K211429 - NAVIPLAN - CT Planning Software for Total Hip Replacement K211429 is a FDA 510(k) cleared radiology medical device. Manufacturer: Naviswiss AG. Cleared Oct 2021. https://www.510kdatabase.net/k211475/ 2021-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k211475-vital-signs-monitors-fda-510k.jpg K211475 - Vital Signs Monitors K211475 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k211508/ 2021-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k211508-steinmann-pins-and-kirschner-wires-fda-510k.jpg K211508 - Steinmann Pins and Kirschner Wires K211508 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker GmbH. Cleared Oct 2021. https://www.510kdatabase.net/k211728/ 2021-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k211728-sterile-hypodermic-syringes-for-single-fda-510k.jpg K211728 - Sterile hypodermic syringes for single use K211728 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Kangyou Medical Instrument Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k212036/ 2021-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k212036-nitrile-powder-free-examination-fda-510k.jpg K212036 - Nitrile Powder Free Examination Gloves,Tested For Use With Chemotherapy Drugs K212036 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Yanfang Medical Technology Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k212233/ 2021-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k212233-rthawk-heartvista-cardiac-package-fda-510k.jpg K212233 - RTHawk, HeartVista Cardiac Package K212233 is a FDA 510(k) cleared radiology medical device. Manufacturer: Heartvista, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k200558/ 2021-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k200558-smart-neck-stimulator-fda-510k.jpg K200558 - Smart Neck Stimulator K200558 is a FDA 510(k) cleared neurology medical device. Manufacturer: Guandong Skg Intelligent Technology Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k201312/ 2021-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k201312-vitros-immunodiagnostic-products-nt-fda-510k.jpg K201312 - VITROS Immunodiagnostic Products NT-proBNP II Reagent Pack K201312 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Ortho-Clinical Diagnostics. Cleared Oct 2021. https://www.510kdatabase.net/k211308/ 2021-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k211308-inni-cera-fda-510k.jpg K211308 - INNI-CERA K211308 is a FDA 510(k) cleared dental medical device. Manufacturer: Aon Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k211368/ 2021-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k211368-ipl-hair-remover-model-g993-g996-g998-fda-510k.jpg K211368 - IPL Hair Remover, Model: G993, G996, G998 and G885 K211368 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Mywin Technology Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k211405/ 2021-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k211405-prelude-guide-sheath-fda-510k.jpg K211405 - Prelude Guide Sheath K211405 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k211425/ 2021-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k211425-private-stock-labs-surgical-face-mask-fda-510k.jpg K211425 - Private Stock Labs Surgical Face Mask K211425 is a FDA 510(k) cleared general hospital medical device. Manufacturer: J.K. Private Stock, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k211745/ 2021-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k211745-recoveryair-pro-fda-510k.jpg K211745 - RecoveryAir PRO K211745 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Theragun, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k211795/ 2021-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k211795-ezdent-i-e2-prora-view-smart-m-viewer-fda-510k.jpg K211795 - EzDent-i/ E2/ Prora View/ Smart M Viewer K211795 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ewoosoft Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k211899/ 2021-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k211899-surgical-face-mask-fda-510k.jpg K211899 - Surgical Face Mask K211899 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hubei Yi-Ya Protective Products Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k212135/ 2021-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k212135-dry-dbm-a-putty-fda-510k.jpg K212135 - Dry DBM- A Putty K212135 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Seaspine Corporation. Cleared Oct 2021. https://www.510kdatabase.net/k201931/ 2021-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k201931-dixi-medical-intraoperative-subdural-fda-510k.jpg K201931 - Dixi Medical Intraoperative Subdural Electrodes (Strips and Grids) K201931 is a FDA 510(k) cleared neurology medical device. Manufacturer: Dixi Medical. Cleared Oct 2021. https://www.510kdatabase.net/k202927/ 2021-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k202927-eye-sync-fda-510k.jpg K202927 - EYE-SYNC K202927 is a FDA 510(k) cleared neurology medical device. Manufacturer: Syncthink, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k200011/ 2021-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k200011-e-class-dual-mobility-inserts-and-fda-510k.jpg K200011 - E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS K200011 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Microport Orthopedics, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k201934/ 2021-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k201934-surgimatix-absorbable-fixation-system-fda-510k.jpg K201934 - Surgimatix Absorbable Fixation System K201934 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Surgimatix, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k210002/ 2021-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k210002-stella-bio-fda-510k.jpg K210002 - STELLA BIO K210002 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Egzotech Sp. Z O. O.. Cleared Oct 2021. https://www.510kdatabase.net/k210139/ 2021-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k210139-ambulatory-blood-pressure-monitor-fda-510k.jpg K210139 - Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 and SA-09 K210139 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edan Instruments, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k210140/ 2021-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k210140-electrocardiograph-se-1202-fda-510k.jpg K210140 - electrocardiograph: SE-1202 K210140 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edan Instruments, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k210270/ 2021-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k210270-medical-endoscope-image-processing-fda-510k.jpg K210270 - Medical Endoscope Image Processing System K210270 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Jiangsu Jiyuan Medical Technology Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k210562/ 2021-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k210562-hrspheres-narrow-size-embolic-fda-510k.jpg K210562 - HRSpheres Narrow-Size Embolic Microspheres K210562 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Suzhou Hengrui Hongyuan Medical Co., Ltd.. Cleared Oct 2021. https://www.510kdatabase.net/k211221/ 2021-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k211221-porous-patella-and-porous-tibia-fda-510k.jpg K211221 - Porous Patella and Porous Tibia Baseplate K211221 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k211332/ 2021-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k211332-d-camera-controller-fda-510k.jpg K211332 - D Camera Controller K211332 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Richard Wolf Medical Instruments Corporation. Cleared Oct 2021. https://www.510kdatabase.net/k212114/ 2021-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k212114-elekta-unity-fda-510k.jpg K212114 - Elekta Unity K212114 is a FDA 510(k) cleared radiology medical device. Manufacturer: Elekta Solutions AB. Cleared Oct 2021. https://www.510kdatabase.net/k212201/ 2021-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k212201-pentax-medical-auto-leakage-tester-sha-fda-510k.jpg K212201 - PENTAX Medical Auto Leakage Tester SHA-P6 K212201 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Pentax of America, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k212414/ 2021-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k212414-ossdsign-cranial-psi-fda-510k.jpg K212414 - OSSDSIGN Cranial PSI K212414 is a FDA 510(k) cleared neurology medical device. Manufacturer: Ossdsign AB. Cleared Oct 2021. https://www.510kdatabase.net/k212433/ 2021-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k212433-anthem-fracture-system-fda-510k.jpg K212433 - Anthem Fracture System K212433 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k212813/ 2021-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k212813-zenition-70-fda-510k.jpg K212813 - Zenition 70 K212813 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Oct 2021. https://www.510kdatabase.net/k212828/ 2021-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k212828-brius-planner-software-fda-510k.jpg K212828 - BRIUS Planner Software K212828 is a FDA 510(k) cleared dental medical device. Manufacturer: Brius Technologies, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/den190055/ 2021-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/den190055-iotasoft-insertion-system-drive-unit-fda-510k.jpg DEN190055 - iotaSOFT Insertion System - Drive Unit, Controller and Accessories DEN190055 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Iotamotion, Inc.. Cleared Oct 2021. https://www.510kdatabase.net/k191288/ 2021-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k191288-acuitas-amr-gene-panel-fda-510k.jpg K191288 - Acuitas AMR Gene Panel K191288 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Opgen, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k203609/ 2021-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k203609-intravascular-administration-sets-fda-510k.jpg K203609 - Intravascular Administration Sets K203609 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corporation. Cleared Sep 2021. https://www.510kdatabase.net/k210523/ 2021-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k210523-implanova-fda-510k.jpg K210523 - Implanova K210523 is a FDA 510(k) cleared dental medical device. Manufacturer: Dental Evolutions, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k211439/ 2021-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k211439-small-bone-nailing-system-fda-510k.jpg K211439 - Small Bone Nailing System K211439 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Skeletal Dynamics, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k211450/ 2021-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k211450-playboy-3-contour-condom-fda-510k.jpg K211450 - Playboy 3 Contour Condom K211450 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Thai Nippon Rubber Industry Public Company Limited.. Cleared Sep 2021. https://www.510kdatabase.net/k211591/ 2021-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k211591-naeotom-alpha-scango-fda-510k.jpg K211591 - NAEOTOM Alpha, Scan&GO K211591 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k211593/ 2021-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k211593-enteral-pump-syringe-fda-510k.jpg K211593 - Enteral Pump Syringe K211593 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Jiangsu Caina Medical Co.,Ltd. Cleared Sep 2021. https://www.510kdatabase.net/k211935/ 2021-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k211935-orio-ti-intervertebral-body-fusion-fda-510k.jpg K211935 - ORIO-Ti Intervertebral Body Fusion Cage System K211935 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinecraft, LLC. Cleared Sep 2021. https://www.510kdatabase.net/k212208/ 2021-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k212208-philips-intellivue-guardiansoftware-fda-510k.jpg K212208 - Philips IntelliVue GuardianSoftware (Rev. E.0X) K212208 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Philips Medizin Systeme Boeblingen GmbH. Cleared Sep 2021. https://www.510kdatabase.net/k212227/ 2021-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k212227-philips-mr-patient-care-portal-fda-510k.jpg K212227 - Philips MR Patient Care Portal K212227 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Invivo Corporation. Cleared Sep 2021. https://www.510kdatabase.net/k212386/ 2021-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k212386-angiovac-f18-85-fda-510k.jpg K212386 - AngioVac F18 85 K212386 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: AngioDynamics, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k212405/ 2021-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k212405-emerge-anterior-cervical-plate-system-fda-510k.jpg K212405 - EMERGE™ Anterior Cervical Plate System K212405 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Evolution Spine. Cleared Sep 2021. https://www.510kdatabase.net/k212757/ 2021-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k212757-jada-system-fda-510k.jpg K212757 - Jada System K212757 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Alydia Health. Cleared Sep 2021. https://www.510kdatabase.net/k212794/ 2021-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k212794-accuray-precision-treatment-planning-fda-510k.jpg K212794 - Accuray Precision Treatment Planning System K212794 is a FDA 510(k) cleared radiology medical device. Manufacturer: Accuray Incorporated. Cleared Sep 2021. https://www.510kdatabase.net/k212805/ 2021-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k212805-stericap-mini-needle-and-standard-fda-510k.jpg K212805 - SteriCap Mini Needle and Standard Needles K212805 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ocuject, LLC. Cleared Sep 2021. https://www.510kdatabase.net/k200639/ 2021-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k200639-lap-ix-fda-510k.jpg K200639 - LAP-iX K200639 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sejong Medical Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k203350/ 2021-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k203350-endotube-fda-510k.jpg K203350 - ENDOtube K203350 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Nissha Medical Technologies Sas. Cleared Sep 2021. https://www.510kdatabase.net/k203668/ 2021-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k203668-reli-nrfit-epidural-needles-phoenix-fda-510k.jpg K203668 - RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles K203668 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Myco Medical Supplies, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k210513/ 2021-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k210513-uniweb-surgical-mask-model-astm-level-fda-510k.jpg K210513 - UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask, Model: ASTM Level 2 K210513 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Universal Incorporation. Cleared Sep 2021. https://www.510kdatabase.net/k210590/ 2021-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k210590-axis-spine-technologies-alif-fda-510k.jpg K210590 - Axis Spine Technologies ALIF K210590 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Axis Spine Technologies, Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k210726/ 2021-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k210726-immersivetouch-fda-510k.jpg K210726 - ImmersiveTouch K210726 is a FDA 510(k) cleared radiology medical device. Manufacturer: Immersivetouch, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k210763/ 2021-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k210763-inman-digital-clear-aligners-fda-510k.jpg K210763 - Inman Digital Clear Aligners K210763 is a FDA 510(k) cleared dental medical device. Manufacturer: Inman Orthodontic Laboratories, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k211740/ 2021-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k211740-dualx-fda-510k.jpg K211740 - DualX K211740 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Amplify Surgical, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k211781/ 2021-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k211781-disposable-nitrile-gloves-fda-510k.jpg K211781 - Disposable Nitrile Gloves K211781 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Jinke Protective Equipment Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k212136/ 2021-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k212136-cochlear-baha-6-system-cochlear-baha-fda-510k.jpg K212136 - Cochlear Baha 6 System, Cochlear Baha Fitting Software 6, Cochlear Baha Baha Smart App K212136 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Cochlear Americas. Cleared Sep 2021. https://www.510kdatabase.net/k212226/ 2021-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k212226-dr-safety-syringe-sterile-hypodermic-fda-510k.jpg K212226 - DR Safety Syringe, Sterile Hypodermic needle for Single use K212226 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zhuhai DR Medical Instruments Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k212238/ 2021-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k212238-theraface-microcurrent-fda-510k.jpg K212238 - TheraFace Microcurrent K212238 is a FDA 510(k) cleared neurology medical device. Manufacturer: Theragun, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k212747/ 2021-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k212747-da-vinci-sp-surgical-system-fda-510k.jpg K212747 - Da Vinci SP Surgical System K212747 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k201855/ 2021-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k201855-electrically-powered-wheelchair-model-fda-510k.jpg K201855 - Electrically Powered Wheelchair -Model HP358E K201855 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Kunshan Hi-Fortune Health Products Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k202481/ 2021-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k202481-thermart-model-ir-eft-fda-510k.jpg K202481 - ThermArt (Model IR-EFT) K202481 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Comper Chuangxiang (Beijing) Technology Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k210561/ 2021-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k210561-advisor-pro-platform-fda-510k.jpg K210561 - Advisor Pro Platform K210561 is a FDA 510(k) cleared chemistry medical device. Manufacturer: DreaMed Diabetes, Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k210878/ 2021-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k210878-surgical-face-mask-model-cm2006-cm2008-fda-510k.jpg K210878 - Surgical Face Mask (Model: CM2006, CM2008, A88) K210878 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen Realtone Medical Appliance Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k210894/ 2021-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k210894-siddharth-ii-fda-510k.jpg K210894 - SIDDHARTH-II K210894 is a FDA 510(k) cleared radiology medical device. Manufacturer: Panacea Medical Technologies Pvt. , Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k211700/ 2021-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k211700-ezdent-web-fda-510k.jpg K211700 - EzDent Web K211700 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ewoosoft Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k211760/ 2021-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k211760-panther-ois-fda-510k.jpg K211760 - Panther OIS K211760 is a FDA 510(k) cleared radiology medical device. Manufacturer: Prowess, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k211794/ 2021-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k211794-disposable-surgical-mask-fda-510k.jpg K211794 - Disposable surgical mask K211794 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shanghai No.9 Knitting Mill Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k211964/ 2021-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k211964-subtlepet-fda-510k.jpg K211964 - SubtlePET K211964 is a FDA 510(k) cleared radiology medical device. Manufacturer: Subtle Medical, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k212045/ 2021-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k212045-softspot-fda-510k.jpg K212045 - SoftSpot K212045 is a FDA 510(k) cleared neurology medical device. Manufacturer: Pediametrix, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k212129/ 2021-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k212129-persona-personalized-knee-system-fda-510k.jpg K212129 - Persona® Personalized Knee System K212129 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer Switzerland Manufacturing GmbH. Cleared Sep 2021. https://www.510kdatabase.net/k212320/ 2021-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k212320-dermatac-drape-and-vac-granufoam-fda-510k.jpg K212320 - Dermatac™ Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology-Small (5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Small (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology - Medium(5 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology -Medium (10 pack), Dermatac Drape and V.A.C. Granufoam Dressings Featuring SensaT.R.A.C. Technology- Large (5 pac K212320 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3M Healthcare Business Group. Cleared Sep 2021. https://www.510kdatabase.net/k203674/ 2021-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k203674-b-dispensing-line-fda-510k.jpg K203674 - B Dispensing Line K203674 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Aea Srl. Cleared Sep 2021. https://www.510kdatabase.net/k211236/ 2021-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k211236-disposable-vinyl-examination-gloves-fda-510k.jpg K211236 - Disposable Vinyl Examination Gloves K211236 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Tangshan Hongyun Healthcare Products Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k212026/ 2021-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k212026-amplatzer-steerable-delivery-sheath-fda-510k.jpg K212026 - Amplatzer Steerable Delivery Sheath K212026 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared Sep 2021. https://www.510kdatabase.net/k212028/ 2021-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k212028-dark-star-navigation-instrument-system-fda-510k.jpg K212028 - Dark Star Navigation Instrument System K212028 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Republic Spine, LLC. Cleared Sep 2021. https://www.510kdatabase.net/k212080/ 2021-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k212080-imaging-plate-scanner-i-scan-fda-510k.jpg K212080 - Imaging Plate Scanner, i-Scan K212080 is a FDA 510(k) cleared radiology medical device. Manufacturer: Guilin Woodpecker Medical Instrument Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k212643/ 2021-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k212643-powerseal-curved-jaw-sealer-and-fda-510k.jpg K212643 - POWERSEAL Curved Jaw Sealer and Divider, Double Action K212643 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Olympus Surgical Technologies America. Cleared Sep 2021. https://www.510kdatabase.net/k212738/ 2021-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k212738-amplatzer-talisman-delivery-sheath-fda-510k.jpg K212738 - Amplatzer Talisman Delivery Sheath K212738 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared Sep 2021. https://www.510kdatabase.net/k212750/ 2021-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k212750-ultrasonic-surgical-aspirator-system-fda-510k.jpg K212750 - Ultrasonic Surgical Aspirator System, Model: XD880B K212750 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smtp Technology Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k201592/ 2021-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k201592-cardinal-health-protexis-pi-blue-with-fda-510k.jpg K201592 - Cardinal Health Protexis PI Blue with Neu-Thera Surgical Glove K201592 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cardinal Health200, LLC. Cleared Sep 2021. https://www.510kdatabase.net/k202459/ 2021-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k202459-bact-trap-filter-bact-trap-mini-bact-fda-510k.jpg K202459 - Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter and Bact-HME Midi HME/Filter K202459 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Pharma System AB. Cleared Sep 2021. https://www.510kdatabase.net/k203731/ 2021-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k203731-dt100-digital-thermometer-fda-510k.jpg K203731 - DT100 Digital Thermometer K203731 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Smart Technology Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k210908/ 2021-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k210908-surgical-mask-fda-510k.jpg K210908 - Surgical Mask K210908 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sichuan Prius Biotechnology Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k212328/ 2021-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k212328-disccath-needle-set-fda-510k.jpg K212328 - DiscCath Needle Set K212328 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Disccath, LLC. Cleared Sep 2021. https://www.510kdatabase.net/k202618/ 2021-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k202618-iv-administration-sets-fda-510k.jpg K202618 - IV Administration Sets K202618 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k210857/ 2021-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k210857-personal-lubricant-fda-510k.jpg K210857 - Personal Lubricant K210857 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shenzhen Huanqiu Xuebao Technology Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k211505/ 2021-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k211505-encore-hip-stem-fda-510k.jpg K211505 - Encore Hip Stem K211505 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Signature Orthopaedics Pty, Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k211973/ 2021-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k211973-dri-cocaine-metabolite-assay-fda-510k.jpg K211973 - DRI Cocaine Metabolite Assay K211973 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Microgenics Corporation. Cleared Sep 2021. https://www.510kdatabase.net/k212099/ 2021-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k212099-red-wave-hair-removal-fda-510k.jpg K212099 - Red Wave Hair Removal K212099 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Accompany Technology Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k212108/ 2021-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k212108-dynamic-tibase-fda-510k.jpg K212108 - Dynamic TiBase K212108 is a FDA 510(k) cleared dental medical device. Manufacturer: Talladium Espa?a, SL. Cleared Sep 2021. https://www.510kdatabase.net/k212125/ 2021-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k212125-nobel-biocare-dental-implant-systems-fda-510k.jpg K212125 - Nobel Biocare Dental Implant Systems Portfolio - MR Conditional K212125 is a FDA 510(k) cleared dental medical device. Manufacturer: Nobel Biocare AG. Cleared Sep 2021. https://www.510kdatabase.net/k212557/ 2021-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k212557-virtual-c-drf-neo-digital-imaging-system-fda-510k.jpg K212557 - Virtual C DRF-NEO Digital Imaging System K212557 is a FDA 510(k) cleared radiology medical device. Manufacturer: Portavision Medical, LLC. Cleared Sep 2021. https://www.510kdatabase.net/k212704/ 2021-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k212704-philips-epiq-diagnostic-ultrasound-fda-510k.jpg K212704 - Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System K212704 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems. Cleared Sep 2021. https://www.510kdatabase.net/k212725/ 2021-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k212725-vipercross-support-catheters-fda-510k.jpg K212725 - ViperCross Support Catheters K212725 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cardiovascular Systems, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k212777/ 2021-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k212777-collaboration-live-fda-510k.jpg K212777 - Collaboration Live K212777 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Ultrasound, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k202092/ 2021-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k202092-abc-dental-implant-system-fda-510k.jpg K202092 - ABC Dental Implant System K202092 is a FDA 510(k) cleared dental medical device. Manufacturer: Abracadabra Implants , Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k203446/ 2021-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k203446-torrentx-wound-wash-fda-510k.jpg K203446 - TorrentX Wound Wash K203446 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Next Science, LLC. Cleared Sep 2021. https://www.510kdatabase.net/k203662/ 2021-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k203662-infrared-thermometer-models-yrk-002a-fda-510k.jpg K203662 - Infrared thermometer, Models: YRK-002A, T8, T9, T10, T11 K203662 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Yibin Junxin Electronics Technology Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k210152/ 2021-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k210152-automatic-digital-blood-pressure-monitor-fda-510k.jpg K210152 - Automatic Digital Blood Pressure Monitor K210152 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Aviche Shandong Medical Technology Co, Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k210232/ 2021-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k210232-sterile-hypodermic-needles-for-single-fda-510k.jpg K210232 - Sterile Hypodermic Needles for Single Use K210232 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zhejiang Kangkang Medical-Devices Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k210294/ 2021-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k210294-one-touch-spiral-condom-fda-510k.jpg K210294 - One Touch Spiral Condom K210294 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Thai Nippon Rubber Industry Public Company Limited.. Cleared Sep 2021. https://www.510kdatabase.net/k210707/ 2021-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k210707-onguard2-chemfort-closed-fda-510k.jpg K210707 - OnGuard2 Chemfort Closed Administration (CADM) K210707 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Simplivia Healthcare , Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k211667/ 2021-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k211667-disposable-medical-synthetic-nitrile-fda-510k.jpg K211667 - Disposable Medical Synthetic Nitrile Examination Gloves (Non-Sterile) K211667 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Changzhou Universal Medical Equipment Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k211747/ 2021-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k211747-reusable-nibp-cuff-fda-510k.jpg K211747 - Reusable NIBP Cuff K211747 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Coreray Technology Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k211827/ 2021-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k211827-level-3-fluid-resistant-fda-510k.jpg K211827 - Level 3 Fluid Resistant Procedure/Surgical Mask (model:15604F, 1570F) K211827 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zhejiang Lanhine Medical Products, Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k211974/ 2021-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k211974-led-photic-system-fda-510k.jpg K211974 - LED PHOTIC System K211974 is a FDA 510(k) cleared neurology medical device. Manufacturer: Micromed S.P.A.. Cleared Sep 2021. https://www.510kdatabase.net/k211996/ 2021-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k211996-nexta-peek-hammertoe-correction-system-fda-510k.jpg K211996 - Nexta PEEK Hammertoe Correction System K211996 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nextremity Solutions, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k212002/ 2021-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k212002-synthetic-vinyl-examination-gloves-fda-510k.jpg K212002 - Synthetic Vinyl Examination Gloves K212002 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Yunnan Huazhiyuan Medical Technology Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k212321/ 2021-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k212321-jivex-model-number-release-53-fda-510k.jpg K212321 - JiveX (Model Number / Release: 5.3) K212321 is a FDA 510(k) cleared radiology medical device. Manufacturer: Visus Health IT GmbH. Cleared Sep 2021. https://www.510kdatabase.net/k212342/ 2021-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k212342-ziip-device-fda-510k.jpg K212342 - ZIIP+ Device K212342 is a FDA 510(k) cleared neurology medical device. Manufacturer: Ziip, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k212411/ 2021-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k212411-identity-imprint-knee-replacement-fda-510k.jpg K212411 - Identity Imprint Knee Replacement System (including Identity Imprint Posterior Stabilized (PS) KRS and Identity Imprint Cruciate Retaining (CR) KRS) K212411 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Conformis, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k212708/ 2021-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k212708-halo-one-thin-walled-guiding-sheath-fda-510k.jpg K212708 - Halo One Thin-Walled Guiding Sheath K212708 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k212728/ 2021-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k212728-standard-bougie-38-fr-and-hand-pump-fda-510k.jpg K212728 - Standard Bougie, 38 Fr. and Hand Pump K212728 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Standard Bariatrics. Cleared Sep 2021. https://www.510kdatabase.net/k212792/ 2021-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k212792-medynus-iva-acif-dlif-plif-tlif-alif-fda-510k.jpg K212792 - Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage K212792 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medynus, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k200423/ 2021-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k200423-electric-wheelchair-xw-ly001-fda-510k.jpg K200423 - Electric Wheelchair (XW-LY001) K200423 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Yongkang Dingchang Industry & Trade Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k210045/ 2021-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k210045-activa-presto-pack-fda-510k.jpg K210045 - ACTIVA PRESTO PACK K210045 is a FDA 510(k) cleared dental medical device. Manufacturer: Pulpdent Corporation. Cleared Sep 2021. https://www.510kdatabase.net/k210263/ 2021-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k210263-mpres-neck-preserving-stem-fda-510k.jpg K210263 - Mpres Neck Preserving Stem K210263 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Sep 2021. https://www.510kdatabase.net/k210772/ 2021-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k210772-3-layer-medical-face-masks-xmm3l3c-3-fda-510k.jpg K210772 - 3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT) K210772 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Vr Vertical, LLC Dba Xrgo. Cleared Sep 2021. https://www.510kdatabase.net/k211097/ 2021-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k211097-banyan-usa-surgical-mask-level-3-fda-510k.jpg K211097 - Banyan USA Surgical Mask Level 3 K211097 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Banyan USA, LLC. Cleared Sep 2021. https://www.510kdatabase.net/k211805/ 2021-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k211805-identiti-porous-ti-interbody-system-fda-510k.jpg K211805 - IdentiTi Porous Ti Interbody System, Transcend PEEK Interbody System, IdentiTi NanoTec Interbody System, Transcend NanoTec Interbody System K211805 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k212160/ 2021-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k212160-simplesense-platform-fda-510k.jpg K212160 - SimpleSENSE Platform K212160 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nanowear, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k212353/ 2021-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k212353-db-ez-bone-void-filler-fda-510k.jpg K212353 - DB-EZ Bone Void Filler K212353 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Dimensional Bioceramics, LLC. Cleared Sep 2021. https://www.510kdatabase.net/k212660/ 2021-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k212660-smylio-invisible-clear-aligners-fda-510k.jpg K212660 - Smylio Invisible Clear Aligners K212660 is a FDA 510(k) cleared dental medical device. Manufacturer: Smylio, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k212667/ 2021-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k212667-single-use-guide-sheath-kit-401-k-402-fda-510k.jpg K212667 - Single Use Guide Sheath Kit-401, K-402 K212667 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Sep 2021. https://www.510kdatabase.net/k212727/ 2021-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k212727-filmarray-pneumonia-panel-fda-510k.jpg K212727 - FilmArray Pneumonia Panel K212727 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Biofire Diagnostics, LLC. Cleared Sep 2021. https://www.510kdatabase.net/k200898/ 2021-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k200898-medicon-hellas-albumin-medicon-hellas-fda-510k.jpg K200898 - Medicon Hellas Albumin, Medicon Hellas Calcium, Medicon Hellas Creatinine, Medicon Hellas Urea Nitrogen, Medicon Hellas Glucose, Medicon Hellas Total Bilirubin, Medicon Hellas Direct Bilirubin K200898 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Medicon Hellas S.A. Cleared Sep 2021. https://www.510kdatabase.net/k201441/ 2021-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k201441-elecsys-troponin-t-gen-5-fda-510k.jpg K201441 - Elecsys Troponin T Gen 5 K201441 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Sep 2021. https://www.510kdatabase.net/k211073/ 2021-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k211073-disposable-nitrile-examination-gloves-fda-510k.jpg K211073 - Disposable Nitrile Examination Gloves K211073 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Foshan Kangkang Biotechnology Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k211689/ 2021-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k211689-keystone-peek-cage-system-fda-510k.jpg K211689 - KEYSTONE PEEK Cage System K211689 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Shanghai Sanyou Medical Co, Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k212287/ 2021-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k212287-dayspring-lite-fda-510k.jpg K212287 - Dayspring Lite K212287 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Koya Medical, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k212303/ 2021-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k212303-t2-fda-510k.jpg K212303 - T2 K212303 is a FDA 510(k) cleared radiology medical device. Manufacturer: Osstem Implant Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k212334/ 2021-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k212334-geo-extremity-and-ankle-plating-system-fda-510k.jpg K212334 - GEO Extremity and Ankle Plating System K212334 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Gramercy Extremity Orthopedics, LLC. Cleared Sep 2021. https://www.510kdatabase.net/k212655/ 2021-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k212655-flyte-fda-510k.jpg K212655 - Flyte K212655 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Pelvital USA, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k212692/ 2021-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k212692-mariner-pedicle-screw-system-fda-510k.jpg K212692 - Mariner Pedicle Screw System K212692 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared Sep 2021. https://www.510kdatabase.net/k212837/ 2021-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k212837-proxidiagnost-n90-fda-510k.jpg K212837 - ProxiDiagnost N90 K212837 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Dmc GmbH. Cleared Sep 2021. https://www.510kdatabase.net/den200080/ 2021-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/den200080-paige-prostate-fda-510k.jpg DEN200080 - Paige Prostate DEN200080 is a FDA 510(k) cleared pathology medical device. Manufacturer: Paige.Ai. Cleared Sep 2021. https://www.510kdatabase.net/k201789/ 2021-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k201789-ct-stor-fda-510k.jpg K201789 - CT-STOR K201789 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Energy Delivery Solutions. Cleared Sep 2021. https://www.510kdatabase.net/k203799/ 2021-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k203799-proflex-co2-laser-fiber-fda-510k.jpg K203799 - ProFlex CO2 Laser Fiber K203799 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Innovaquartz, LLC. Cleared Sep 2021. https://www.510kdatabase.net/k210440/ 2021-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k210440-disposable-sampler-inactivated-fda-510k.jpg K210440 - Disposable Sampler Inactivated Transport Media, Nest ITM K210440 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Wuxi Nest Biotechnology Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k210955/ 2021-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k210955-kubtec-mozart-supra-xpert-84-fda-510k.jpg K210955 - Kubtec Mozart Supra (XPERT 84) Radiography System K210955 is a FDA 510(k) cleared radiology medical device. Manufacturer: Kub Technologies, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k211477/ 2021-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k211477-latex-examination-powder-free-gloves-fda-510k.jpg K211477 - Latex Examination Powder Free Gloves K211477 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Aspen Glove Sdn. Bhd.. Cleared Sep 2021. https://www.510kdatabase.net/k211922/ 2021-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k211922-ipl-home-use-hair-removal-device-fda-510k.jpg K211922 - IPL Home Use Hair Removal Device K211922 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Beauty Every Moment Intelligent Electric Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k211931/ 2021-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k211931-medline-digital-thermometer-non-fda-510k.jpg K211931 - Medline Digital Thermometer Non-Lubricated Probe Sheath K211931 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k212224/ 2021-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k212224-tracstar-ldp-large-distal-platform-fda-510k.jpg K212224 - TracStar LDP Large Distal Platform K212224 is a FDA 510(k) cleared neurology medical device. Manufacturer: Imperative Care, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k212961/ 2021-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k212961-smilers-fda-510k.jpg K212961 - SMILERS K212961 is a FDA 510(k) cleared dental medical device. Manufacturer: Biotech Dental Smilers, Sas. Cleared Sep 2021. https://www.510kdatabase.net/k201832/ 2021-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k201832-endoeye-flex-deflectable-videoscope-fda-510k.jpg K201832 - Endoeye Flex Deflectable Videoscope Olympus LTF-S190-5 K201832 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Sep 2021. https://www.510kdatabase.net/k202790/ 2021-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k202790-syntec-orthodontic-mini-screw-extended-fda-510k.jpg K202790 - Syntec Orthodontic Mini Screw Extended System K202790 is a FDA 510(k) cleared dental medical device. Manufacturer: Syntec Scientific Corporation. Cleared Sep 2021. https://www.510kdatabase.net/k203141/ 2021-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k203141-uramix-curaway-biopsy-needle-fda-510k.jpg K203141 - Uramix CuraWay Biopsy Needle K203141 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Uramix, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k203155/ 2021-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k203155-breathesuite-mdi-v1-fda-510k.jpg K203155 - BreatheSuite MDI V1 K203155 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Breathesuite, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k203418/ 2021-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k203418-surgical-mask-procedure-mask-models-fda-510k.jpg K203418 - Surgical Mask (Procedure Mask) (Models: OH02-01, OH02-01 (Bandage)) K203418 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ningbo Ouhan Medical Device Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k203762/ 2021-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k203762-nellcor-easycap-ii-adult-colorimetric-fda-510k.jpg K203762 - Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector K203762 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Covidien. Cleared Sep 2021. https://www.510kdatabase.net/k203845/ 2021-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k203845-philips-intellisite-pathology-solution-fda-510k.jpg K203845 - Philips IntelliSite Pathology Solution K203845 is a FDA 510(k) cleared pathology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Sep 2021. https://www.510kdatabase.net/k210399/ 2021-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k210399-unifine-safecontrol-fda-510k.jpg K210399 - Unifine SafeControl K210399 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Owen Mumford, Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k210441/ 2021-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k210441-incontinence-probe-fda-510k.jpg K210441 - Incontinence Probe K210441 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Shenzhen Med-Link Electronics Tech Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k211158/ 2021-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k211158-nti-clenchguard-fda-510k.jpg K211158 - NTI ClenchGuard K211158 is a FDA 510(k) cleared dental medical device. Manufacturer: Boyd Research, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k211234/ 2021-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k211234-redex-fda-510k.jpg K211234 - RedEx K211234 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Advanced Surgical Concepts, Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k211751/ 2021-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k211751-welltrust-wt-iii-mask-with-flat-earloop-fda-510k.jpg K211751 - WELLTRUST WT-III Mask with Flat Earloop K211751 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Lonestar Meadows, LLC. Cleared Sep 2021. https://www.510kdatabase.net/k211904/ 2021-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k211904-vinyl-glove-fda-510k.jpg K211904 - Vinyl Glove K211904 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Dihong Industry and Trade Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k212067/ 2021-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k212067-deep-learning-image-reconstruction-fda-510k.jpg K212067 - Deep Learning Image Reconstruction K212067 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare Japan Corporation. Cleared Sep 2021. https://www.510kdatabase.net/k212269/ 2021-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k212269-intelligent-nr-fda-510k.jpg K212269 - Intelligent NR K212269 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k212272/ 2021-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k212272-tempo-natural-tampon-fda-510k.jpg K212272 - Tempo Natural Tampon K212272 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Dong-A Pharmaceutical Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k203111/ 2021-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k203111-affinity-fusion-oxygenator-system-fda-510k.jpg K203111 - Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System K203111 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic. Cleared Sep 2021. https://www.510kdatabase.net/k203112/ 2021-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k203112-disposable-medical-mask-fda-510k.jpg K203112 - Disposable Medical Mask K203112 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Yangzhou Runyi Arts & Crafts Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k211478/ 2021-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k211478-sterile-latex-surgical-gloves-powder-fda-510k.jpg K211478 - Sterile Latex Surgical Gloves Powder Free K211478 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Aspen Glove Sdn. Bhd.. Cleared Sep 2021. https://www.510kdatabase.net/k211479/ 2021-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k211479-blue-nitrile-examination-glove-powder-fda-510k.jpg K211479 - Blue Nitrile Examination Glove Powder Free K211479 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Aspen Glove Sdn. Bhd.. Cleared Sep 2021. https://www.510kdatabase.net/k211512/ 2021-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k211512-visionaire-uk-patient-matched-cutting-fda-510k.jpg K211512 - VISIONAIRE UK Patient Matched Cutting Guides K211512 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k212021/ 2021-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k212021-6430-mylabx75-6430-mylab-xpro75-fda-510k.jpg K212021 - 6430 MyLabX75, 6430 MyLab XPro75 K212021 is a FDA 510(k) cleared radiology medical device. Manufacturer: Esaote, S.P.A.. Cleared Sep 2021. https://www.510kdatabase.net/k212283/ 2021-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k212283-bioroot-flow-05g-bioroot-flow-2g-fda-510k.jpg K212283 - BioRoot Flow 0.5g, BioRoot Flow 2g K212283 is a FDA 510(k) cleared dental medical device. Manufacturer: Septodont. Cleared Sep 2021. https://www.510kdatabase.net/k212604/ 2021-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k212604-symbia-va10a-family-fda-510k.jpg K212604 - Symbia VA10A Family K212604 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k212641/ 2021-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k212641-stratamr-ii-valves-and-shunts-fda-510k.jpg K212641 - StrataMR II Valves and Shunts K212641 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Neurosurgery. Cleared Sep 2021. https://www.510kdatabase.net/k212742/ 2021-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k212742-gemini-sl-total-knee-system-endo-model-fda-510k.jpg K212742 - GEMINI SL Total Knee System, Endo-Model Knee System, and Sled Knee System with LINK PorEx (TiNbN) inhouse coating K212742 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Waldemar Link GmbH & Co. KG. Cleared Sep 2021. https://www.510kdatabase.net/k202369/ 2021-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k202369-rxs-1000-fda-510k.jpg K202369 - RXS 1000 K202369 is a FDA 510(k) cleared radiology medical device. Manufacturer: Rolence Enterprise, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k202885/ 2021-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k202885-glucosure-ht-plus-blood-glucose-fda-510k.jpg K202885 - GlucoSure HT Plus Blood Glucose Monitoring System K202885 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Apex BioTechnology Corp.. Cleared Sep 2021. https://www.510kdatabase.net/k203492/ 2021-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k203492-instrument-tray-for-semi-rigid-fda-510k.jpg K203492 - Instrument tray, for semi-rigid ureteroscope K203492 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Olympus Winter & Ibe GmbH. Cleared Sep 2021. https://www.510kdatabase.net/k203649/ 2021-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k203649-truabutment-ds-trubase-fda-510k.jpg K203649 - TruAbutment DS, TruBase K203649 is a FDA 510(k) cleared dental medical device. Manufacturer: Truabutment, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k210085/ 2021-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k210085-healthccsng-fda-510k.jpg K210085 - HealthCCSng K210085 is a FDA 510(k) cleared radiology medical device. Manufacturer: Zebra Medical Vision, Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k210118/ 2021-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k210118-infrared-body-thermometer-model-yk-001-fda-510k.jpg K210118 - INFRARED BODY THERMOMETER (Model: YK-001) K210118 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Longnan Renzhong Medical Equipment Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k210818/ 2021-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k210818-truecare-biomedix-tamper-evident-cap-fda-510k.jpg K210818 - TrueCare Biomedix Tamper Evident Cap K210818 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Us Infusion Inc. D/B/A Truecare Biomedix-USA. Cleared Sep 2021. https://www.510kdatabase.net/k211227/ 2021-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k211227-htx-disposable-hysteroscope-system-fda-510k.jpg K211227 - HTx Disposable Hysteroscope System K211227 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Acuvu, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k211276/ 2021-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k211276-reprocessed-dynamic-tip-and-xt-fda-510k.jpg K211276 - Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters K211276 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Innovative Health, LLC. Cleared Sep 2021. https://www.510kdatabase.net/k212009/ 2021-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k212009-disposable-nitrile-gloves-fda-510k.jpg K212009 - Disposable Nitrile Gloves K212009 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Shenglijie Safety Products Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k212556/ 2021-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k212556-mi-eye-3-needlescope-with-cannula-mi-fda-510k.jpg K212556 - mi-eye 3 needlescope with cannula, mi-tablet 3 K212556 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Trice Medical, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k212606/ 2021-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k212606-beamsite-fda-510k.jpg K212606 - BeamSite K212606 is a FDA 510(k) cleared radiology medical device. Manufacturer: Doseoptics, LLC. Cleared Sep 2021. https://www.510kdatabase.net/k212710/ 2021-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k212710-global-unite-platform-shoulder-system-fda-510k.jpg K212710 - GLOBAL UNITE™ Platform Shoulder System K212710 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Ireland UC. Cleared Sep 2021. https://www.510kdatabase.net/k193650/ 2021-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k193650-liaison-ferritin-fda-510k.jpg K193650 - LIAISON Ferritin K193650 is a FDA 510(k) cleared immunology medical device. Manufacturer: DiaSorin, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k202396/ 2021-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k202396-vitek-2-ast-gram-positive-fosfomycin-8-fda-510k.jpg K202396 - VITEK 2 AST-Gram Positive Fosfomycin (<=8 - >=256 ug/mL) K202396 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k210184/ 2021-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k210184-wilson-tech-disposable-medical-face-mask-fda-510k.jpg K210184 - Wilson Tech Disposable Medical Face Mask K210184 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wilson Tech (International) Limited. Cleared Sep 2021. https://www.510kdatabase.net/k210461/ 2021-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k210461-end-cap-fda-510k.jpg K210461 - End Cap K210461 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medical Components Inc (Medcomp). Cleared Sep 2021. https://www.510kdatabase.net/k210586/ 2021-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k210586-diamonback-360-peripheral-orbital-fda-510k.jpg K210586 - Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system K210586 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cardiovascular Systems, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k211283/ 2021-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k211283-compressible-limb-and-circulation-fda-510k.jpg K211283 - Compressible Limb and Circulation Therapy System, Model POWER-Q2300 K211283 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Wonjin Mulsan Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k211305/ 2021-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k211305-anne-one-fda-510k.jpg K211305 - ANNE One K211305 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sibel, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k211389/ 2021-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k211389-magstim-horizon-30-tms-therapy-system-fda-510k.jpg K211389 - Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0 with Navigation K211389 is a FDA 510(k) cleared neurology medical device. Manufacturer: Magstim Company, Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k211464/ 2021-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k211464-nitta-mt-safety-box-fda-510k.jpg K211464 - Nitta M&T Safety Box K211464 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Nitta M&T (Thailand) Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k211474/ 2021-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k211474-kleiner-kg2-system-fda-510k.jpg K211474 - Kleiner KG2 System K211474 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: BAAT Medical Products B.V.. Cleared Sep 2021. https://www.510kdatabase.net/k211494/ 2021-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k211494-polaris-x-unidirectional-steerable-fda-510k.jpg K211494 - Polaris X Unidirectional Steerable Diagnostic Catheter K211494 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Sep 2021. https://www.510kdatabase.net/k211738/ 2021-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k211738-rotarex-atherectomy-system-fda-510k.jpg K211738 - Rotarex Atherectomy System K211738 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k212291/ 2021-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k212291-phoenix-fda-510k.jpg K212291 - PHOENIX K212291 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sedecal., Sa.. Cleared Sep 2021. https://www.510kdatabase.net/k212678/ 2021-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k212678-viveve-system-viveve-20-system-fda-510k.jpg K212678 - Viveve System, Viveve 2.0 System K212678 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Viveve Medical, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k201793/ 2021-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k201793-eden-peek-cage-fda-510k.jpg K201793 - EDEN Peek Cage K201793 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Jmt Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k202540/ 2021-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k202540-elia-rib-p-fda-510k.jpg K202540 - EliA Rib-P K202540 is a FDA 510(k) cleared immunology medical device. Manufacturer: Phadia AB. Cleared Sep 2021. https://www.510kdatabase.net/k202541/ 2021-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k202541-elia-rna-pol-iii-fda-510k.jpg K202541 - EliA RNA Pol III K202541 is a FDA 510(k) cleared immunology medical device. Manufacturer: Phadia AB. Cleared Sep 2021. https://www.510kdatabase.net/k203455/ 2021-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k203455-disposable-medical-mask-fda-510k.jpg K203455 - Disposable Medical Mask K203455 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Fujian Kang Chen Daily Necessities Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k210396/ 2021-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k210396-harmony-referral-system-fda-510k.jpg K210396 - Harmony Referral System K210396 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Topcon Healthcare Solutions EMEA Oy. Cleared Sep 2021. https://www.510kdatabase.net/k211270/ 2021-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k211270-civ-clear-cover-fda-510k.jpg K211270 - CIV-Clear cover K211270 is a FDA 510(k) cleared radiology medical device. Manufacturer: CIVCO Medical Instruments Co., Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k212214/ 2021-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k212214-handx-fda-510k.jpg K212214 - HandX K212214 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Human Xtensions , Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k212412/ 2021-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k212412-iris-xp-fda-510k.jpg K212412 - IRIS-XP K212412 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medicore Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k212685/ 2021-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k212685-konicaminolta-di-x1-fda-510k.jpg K212685 - KONICAMINOLTA DI-X1 K212685 is a FDA 510(k) cleared radiology medical device. Manufacturer: Konica Minolta, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k211296/ 2021-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k211296-surgical-face-mask-fda-510k.jpg K211296 - Surgical face mask K211296 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sunsmed Protective Products , Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k202056/ 2021-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k202056-kinepict-medical-imaging-tool-40-fda-510k.jpg K202056 - Kinepict Medical Imaging Tool 4.0 K202056 is a FDA 510(k) cleared radiology medical device. Manufacturer: Kinepict Health, Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k203785/ 2021-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k203785-clarisigmam-fda-510k.jpg K203785 - ClariSIGMAM K203785 is a FDA 510(k) cleared radiology medical device. Manufacturer: Claripi, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k210093/ 2021-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k210093-accuffrangio-fda-510k.jpg K210093 - AccuFFRangio K210093 is a FDA 510(k) cleared radiology medical device. Manufacturer: ArteryFlow Technology Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k210160/ 2021-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k210160-alertwatchac-fda-510k.jpg K210160 - AlertWatch:AC K210160 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Alertwatch, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k210227/ 2021-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k210227-sterile-syringe-for-single-use-fda-510k.jpg K210227 - Sterile syringe for single use with/without needle K210227 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zhejiang Kangkang Medical-Devices Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k210410/ 2021-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k210410-s-clean-pre-milled-abutment-mini-fda-510k.jpg K210410 - s-Clean Pre-Milled Abutment Mini K210410 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentis Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k210438/ 2021-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k210438-versana-premier-fda-510k.jpg K210438 - Versana Premier K210438 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared Sep 2021. https://www.510kdatabase.net/k210625/ 2021-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k210625-jazz-suction-valve-jazz-airwater-valve-fda-510k.jpg K210625 - JAZZ Suction Valve, JAZZ Air/Water Valve, JAZZ Forceps Valve K210625 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fujifilm Medwork GmbH. Cleared Sep 2021. https://www.510kdatabase.net/k211257/ 2021-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k211257-efai-pacs-picture-archiving-and-fda-510k.jpg K211257 - EFAI PACS Picture Archiving and Communication System K211257 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ever Fortune.Ai, Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k211334/ 2021-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k211334-iovera-system-fda-510k.jpg K211334 - Iovera System K211334 is a FDA 510(k) cleared neurology medical device. Manufacturer: Pacira Pharmaceuticals, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k211375/ 2021-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k211375-blazer-dx-20-bidirectional-steerable-fda-510k.jpg K211375 - Blazer™ Dx-20 Bidirectional Steerable Diagnostic Catheter K211375 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Sep 2021. https://www.510kdatabase.net/k211488/ 2021-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k211488-logiq-e10-fda-510k.jpg K211488 - LOGIQ E10 K211488 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Sep 2021. https://www.510kdatabase.net/k211828/ 2021-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k211828-aquilion-exceed-lb-fda-510k.jpg K211828 - Aquilion Exceed LB K211828 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Sep 2021. https://www.510kdatabase.net/k211856/ 2021-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k211856-gammacore-sapphire-fda-510k.jpg K211856 - gammaCore Sapphire K211856 is a FDA 510(k) cleared neurology medical device. Manufacturer: Electrocore, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k212451/ 2021-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k212451-surgical-mask-fda-510k.jpg K212451 - Surgical Mask K212451 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Remade USA, LLC. Cleared Sep 2021. https://www.510kdatabase.net/k212540/ 2021-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k212540-explorer-to-system-fda-510k.jpg K212540 - Explorer TO System K212540 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared Sep 2021. https://www.510kdatabase.net/k201785/ 2021-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k201785-epien-dental-cleanser-fda-510k.jpg K201785 - EPIEN Dental Cleanser K201785 is a FDA 510(k) cleared dental medical device. Manufacturer: Epien Medical, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k210385/ 2021-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k210385-cobas-cdiff-nucleic-acid-test-for-use-fda-510k.jpg K210385 - cobas Cdiff nucleic acid test for use on the cobas Liat System K210385 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Molecular Systems, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k210402/ 2021-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k210402-curiteva-sacroiliac-joint-fusion-system-fda-510k.jpg K210402 - Curiteva Sacroiliac Joint Fusion System K210402 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Curiteva, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k210509/ 2021-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k210509-rocket-platinum-cured-cathter-fda-510k.jpg K210509 - Rocket Platinum Cured Cathter K210509 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Rocket Medical Plc. Cleared Sep 2021. https://www.510kdatabase.net/k211242/ 2021-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k211242-promisemed-sterile-hypodermic-syringes-fda-510k.jpg K211242 - Promisemed Sterile Hypodermic Syringes, Verifine Sterile Hypodermic Syringes K211242 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Promisemed Hangzhou Meditech Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k211352/ 2021-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k211352-electronic-thermometer-xhf2001-xhf2002-fda-510k.jpg K211352 - Electronic Thermometer (XHF2001, XHF2002) K211352 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Putian Hanjiang Huafeng Plastic Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k211824/ 2021-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k211824-hera-w9-hera-w10-diagnostic-ultrasound-fda-510k.jpg K211824 - HERA W9, HERA W10 Diagnostic Ultrasound System K211824 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Medison Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k212246/ 2021-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k212246-exofin-precision-pen-fda-510k.jpg K212246 - Exofin Precision Pen K212246 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Chemence Medical, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k212553/ 2021-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k212553-digital-radiography-cxdi-pro-d1-fda-510k.jpg K212553 - DIGITAL RADIOGRAPHY CXDI-Pro, D1 K212553 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k203434/ 2021-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k203434-bluestar-rx-fda-510k.jpg K203434 - BlueStar Rx K203434 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Welldoc, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k203555/ 2021-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k203555-amcad-ut-fda-510k.jpg K203555 - AmCAD-UT K203555 is a FDA 510(k) cleared radiology medical device. Manufacturer: Amcad Biomed Corporation. Cleared Sep 2021. https://www.510kdatabase.net/k210712/ 2021-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k210712-verifine-mechanical-safety-insulin-fda-510k.jpg K210712 - Verifine Mechanical Safety Insulin Syringe K210712 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Promisemed Hangzhou Meditech Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k211127/ 2021-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k211127-full-automatic-nibp-blood-pressure-fda-510k.jpg K211127 - Full Automatic (NIBP) Blood Pressure Monitor, Model HL858DM K211127 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Health & Life Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k211235/ 2021-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k211235-circul8-luxe-dvt-prevention-device-fda-510k.jpg K211235 - CIRCUL8 Luxe DVT Prevention Device K211235 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ortho8, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k211597/ 2021-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k211597-epiq-series-diagnostic-ultrasound-fda-510k.jpg K211597 - EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System K211597 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems. Cleared Sep 2021. https://www.510kdatabase.net/k211832/ 2021-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k211832-fluid-resistant-procedure-mask-fluid-fda-510k.jpg K211832 - Fluid Resistant Procedure Mask, Fluid Resistant Surgical Mask K211832 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zhejiang Lanhine Medical Products, Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k211867/ 2021-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k211867-raystation-110-fda-510k.jpg K211867 - RayStation 11.0 K211867 is a FDA 510(k) cleared radiology medical device. Manufacturer: RaySearch Laboratories AB (PUBL). Cleared Sep 2021. https://www.510kdatabase.net/k211945/ 2021-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k211945-v8-diagnostic-ultrasound-system-fda-510k.jpg K211945 - V8 Diagnostic Ultrasound System K211945 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Medison Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k212058/ 2021-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k212058-longeviti-clearfit-ots-cranial-implants-fda-510k.jpg K212058 - Longeviti ClearFit™ OTS Cranial Implants K212058 is a FDA 510(k) cleared neurology medical device. Manufacturer: Longeviti Neuro Solutions, LLC. Cleared Sep 2021. https://www.510kdatabase.net/k212495/ 2021-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k212495-leva-pelvic-health-system-fda-510k.jpg K212495 - Leva Pelvic Health System K212495 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Renovia, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/den200030/ 2021-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/den200030-feops-heartguide-fda-510k.jpg DEN200030 - FEops HEARTguide DEN200030 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Feops NV. Cleared Sep 2021. https://www.510kdatabase.net/k202049/ 2021-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k202049-python-catheterover-the-wire-latis-fda-510k.jpg K202049 - Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter K202049 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Applied Medical Resources Corporation. Cleared Sep 2021. https://www.510kdatabase.net/k210997/ 2021-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k210997-preferx-delivery-system-fda-510k.jpg K210997 - PreferX Delivery System K210997 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Md3, LLC. Cleared Sep 2021. https://www.510kdatabase.net/k211579/ 2021-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k211579-coolseal-trinity-30-cm-shaft-coolseal-fda-510k.jpg K211579 - CoolSeal Trinity (30 cm shaft), CoolSeal Trinity (37 cm shaft), CoolSeal Trinity (44 cm shaft) K211579 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bolder Surgical, LLC. Cleared Sep 2021. https://www.510kdatabase.net/k211607/ 2021-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k211607-system-1e-liquid-chemical-sterilant-fda-510k.jpg K211607 - SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate K211607 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Sep 2021. https://www.510kdatabase.net/k211769/ 2021-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k211769-onelif-intervertebral-body-replacement-fda-510k.jpg K211769 - OneLIF Intervertebral Body Replacement System K211769 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Novapproach Spine. Cleared Sep 2021. https://www.510kdatabase.net/k202796/ 2021-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k202796-sansin-tubing-sets-for-hemodialysis-fda-510k.jpg K202796 - SANSIN Tubing Sets for Hemodialysis K202796 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Jiangxi Sanxin Medtec Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k211736/ 2021-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k211736-electronic-muscle-stimulator-model-ast-fda-510k.jpg K211736 - Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W) K211736 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Osto Technology Company Limited. Cleared Sep 2021. https://www.510kdatabase.net/k212081/ 2021-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k212081-3mtm-complytm-hydrogen-peroxide-fda-510k.jpg K212081 - 3M(TM) Comply(TM) Hydrogen Peroxide Indicator Tape 1228 K212081 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Sep 2021. https://www.510kdatabase.net/k201305/ 2021-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k201305-auto-transfusion-ats-chest-drains-fda-510k.jpg K201305 - Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain K201305 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Atrium Medical Corporation. Cleared Sep 2021. https://www.510kdatabase.net/k202689/ 2021-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k202689-dentilube-spray-fda-510k.jpg K202689 - Dentilube Spray K202689 is a FDA 510(k) cleared dental medical device. Manufacturer: Oxy2plus, LLC. Cleared Sep 2021. https://www.510kdatabase.net/k202786/ 2021-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k202786-dental-low-speed-handpieces-and-fda-510k.jpg K202786 - Dental Low-speed Handpieces and Accessories K202786 is a FDA 510(k) cleared dental medical device. Manufacturer: Microp Technology (Taiwan), Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k203536/ 2021-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k203536-male-latex-condom-fda-510k.jpg K203536 - Male Latex Condom K203536 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Global Protection Corp.. Cleared Sep 2021. https://www.510kdatabase.net/k210133/ 2021-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k210133-current-health-monitoring-system-gen-2-fda-510k.jpg K210133 - Current Health Monitoring System Gen 2 (G2) K210133 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Current Health. Cleared Sep 2021. https://www.510kdatabase.net/k210342/ 2021-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k210342-bioshield-ercp-biopsy-valve-bioshield-fda-510k.jpg K210342 - BioShield- ERCP Biopsy Valve, BioShield Irrigator - Extension Tubing, BioShield Irrigating Adaptor K210342 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: STERIS Corporation. Cleared Sep 2021. https://www.510kdatabase.net/k210470/ 2021-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k210470-c-curve-interbody-fusion-device-fda-510k.jpg K210470 - C-CURVE Interbody Fusion Device K210470 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medicrea International SA. Cleared Sep 2021. https://www.510kdatabase.net/k210861/ 2021-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k210861-reunion-reversible-fracture-system-rfx-fda-510k.jpg K210861 - ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) K210861 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker GmbH. Cleared Sep 2021. https://www.510kdatabase.net/k210940/ 2021-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k210940-luxaprint-ortho-plus-fda-510k.jpg K210940 - LuxaPrint Ortho Plus K210940 is a FDA 510(k) cleared dental medical device. Manufacturer: Dmg Digital Enterprises SE. Cleared Sep 2021. https://www.510kdatabase.net/k211200/ 2021-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k211200-woundexpress-fda-510k.jpg K211200 - WoundExpress K211200 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Huntleigh Healthcare , Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k211583/ 2021-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k211583-infrared-thermometer-model-hw-1-fda-510k.jpg K211583 - Infrared Thermometer, Model: HW-1 K211583 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Dongguan Simzo Electronic Technology Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k211637/ 2021-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k211637-aroma-grand-fda-510k.jpg K211637 - AROMA GRAND K211637 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Daeju Meditech Engineering Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k211762/ 2021-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k211762-altor-safety-4-ply-surgical-mask-fda-510k.jpg K211762 - Altor Safety 4-Ply Surgical Mask (Model:62232) K211762 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Altor Safety, LLC. Cleared Sep 2021. https://www.510kdatabase.net/k212421/ 2021-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k212421-adas-3d-fda-510k.jpg K212421 - ADAS 3D K212421 is a FDA 510(k) cleared radiology medical device. Manufacturer: Adas3D Medical S.L.. Cleared Sep 2021. https://www.510kdatabase.net/k212476/ 2021-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k212476-karl-storz-flexible-hd-cysto-fda-510k.jpg K212476 - KARL STORZ Flexible HD Cysto-Urethroscope System K212476 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k201445/ 2021-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k201445-multicath-acqrate-dx-fixed-curve-fda-510k.jpg K201445 - MultiCath, AcQRate Dx Fixed Curve Catheter K201445 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biotronik, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k201612/ 2021-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k201612-elegant-2-in-1-vaginal-moisturizer-fda-510k.jpg K201612 - Elegant 2 in 1 Vaginal Moisturizer, Elegant Advanced 5 K201612 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Viramal Limited. Cleared Sep 2021. https://www.510kdatabase.net/k203722/ 2021-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k203722-raypilot-system-fda-510k.jpg K203722 - RayPilot System K203722 is a FDA 510(k) cleared radiology medical device. Manufacturer: Micropos Medical AB. Cleared Sep 2021. https://www.510kdatabase.net/k210868/ 2021-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k210868-nitrile-examination-gloves-powder-free-fda-510k.jpg K210868 - Nitrile Examination Gloves Powder Free (Blue) K210868 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Great Eco Glove Sdn. Bhd.. Cleared Sep 2021. https://www.510kdatabase.net/k211074/ 2021-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k211074-univers-revers-modular-glenoid-system-fda-510k.jpg K211074 - Univers Revers Modular Glenoid System, Standard Augment Baseplates K211074 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k211201/ 2021-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k211201-magnetos-easypack-putty-fda-510k.jpg K211201 - MagnetOs Easypack Putty K211201 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Kuros Biosciences B.V. Cleared Sep 2021. https://www.510kdatabase.net/k211778/ 2021-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k211778-nitrile-examination-gloves-green-blue-fda-510k.jpg K211778 - Nitrile Examination Gloves, Green/ Blue/ Black Color K211778 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zhenjiang Suhui Latex Products Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k211881/ 2021-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k211881-ai-segmentation-fda-510k.jpg K211881 - AI Segmentation K211881 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k212491/ 2021-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k212491-air-relax-pro-model-ar-40-fda-510k.jpg K212491 - Air Relax Pro Model AR-4.0 K212491 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Diode Art Engineering Doing Business AS Air Relax. Cleared Sep 2021. https://www.510kdatabase.net/k212494/ 2021-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k212494-lung-image-analysis-fda-510k.jpg K212494 - Lung Image Analysis K212494 is a FDA 510(k) cleared radiology medical device. Manufacturer: Pulmonx Corporation. Cleared Sep 2021. https://www.510kdatabase.net/k201258/ 2021-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k201258-easymax-tag-self-monitoring-blood-fda-510k.jpg K201258 - EASYMAX Tag Self-Monitoring Blood Glucose System K201258 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eps Bio Technology Corp.. Cleared Sep 2021. https://www.510kdatabase.net/k202204/ 2021-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k202204-tracheal-stent-system-fda-510k.jpg K202204 - Tracheal Stent System K202204 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Micro-Tech (Nanjing) Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k202395/ 2021-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k202395-sp-1000-sp-2000-fda-510k.jpg K202395 - SP-1000, SP-2000 K202395 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Daesung Maref Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k203014/ 2021-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k203014-endolif-delta-cage-and-doublewedge-cage-fda-510k.jpg K203014 - EndoLIF Delta-Cage and DoubleWedge-Cage K203014 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Joimax GmbH. Cleared Sep 2021. https://www.510kdatabase.net/k203625/ 2021-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k203625-numen-coil-embolization-system-fda-510k.jpg K203625 - Numen Coil Embolization System K203625 is a FDA 510(k) cleared neurology medical device. Manufacturer: MicroPort NeuroTech (Shanghai) Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k210032/ 2021-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k210032-leadtek-fingertip-pulse-oximeter-fda-510k.jpg K210032 - Leadtek Fingertip Pulse Oximeter (Wireless), Leadtek Fingertip Pulse Oximeter (Wireless) K210032 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Leadtek Research, Inc.. Cleared Sep 2021. https://www.510kdatabase.net/k210254/ 2021-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k210254-memed-bv-fda-510k.jpg K210254 - MeMed BV K210254 is a FDA 510(k) cleared microbiology medical device. Manufacturer: MeMed Diagnostics, Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k210901/ 2021-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k210901-elecsys-vitamin-d-total-iii-fda-510k.jpg K210901 - Elecsys Vitamin D total III K210901 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Sep 2021. https://www.510kdatabase.net/k210951/ 2021-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k210951-leonardo-mini-blue-fda-510k.jpg K210951 - Leonardo Mini Blue K210951 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ceramoptec GmbH. Cleared Sep 2021. https://www.510kdatabase.net/k211174/ 2021-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k211174-ipl-hair-removal-fda-510k.jpg K211174 - IPL Hair Removal K211174 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Qiaochengli Technology Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k211367/ 2021-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k211367-evo-seeg-system-fda-510k.jpg K211367 - Evo sEEG System K211367 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neuroone Medical Technologies Corp.. Cleared Sep 2021. https://www.510kdatabase.net/k211536/ 2021-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k211536-welspun-health-surgical-mask-fda-510k.jpg K211536 - Welspun Health Surgical Mask K211536 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Welspun India Limited. Cleared Sep 2021. https://www.510kdatabase.net/k211673/ 2021-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k211673-disposable-medical-nitrile-gloves-fda-510k.jpg K211673 - Disposable Medical Nitrile Gloves K211673 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Changzhou Yihua Sanitation Material Co., Ltd.. Cleared Sep 2021. https://www.510kdatabase.net/k211823/ 2021-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k211823-bonine-acupressure-bands-fda-510k.jpg K211823 - Bonine Acupressure Bands K211823 is a FDA 510(k) cleared neurology medical device. Manufacturer: Wellspring Pharmaceutical Corporation. Cleared Sep 2021. https://www.510kdatabase.net/k211972/ 2021-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k211972-omeza-collagen-matrix-fda-510k.jpg K211972 - Omeza Collagen Matrix K211972 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Omeza, LLC. Cleared Sep 2021. https://www.510kdatabase.net/k212139/ 2021-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k212139-admiral-acp-system-fda-510k.jpg K212139 - Admiral ACP System K212139 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared Sep 2021. https://www.510kdatabase.net/k201560/ 2021-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k201560-auto-lung-nodule-detection-fda-510k.jpg K201560 - Auto Lung Nodule Detection K201560 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Electronics Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k203084/ 2021-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k203084-ablamap-software-fda-510k.jpg K203084 - Ablamap Software K203084 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ablacon, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k203636/ 2021-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k203636-pluscare-temperature-probes-skin-types-fda-510k.jpg K203636 - PlusCare Temperature Probes, Skin Types: PT2252-AS, PTHP-AS, PTMQ-AS, PTSW-AS, PTSM-15AS, PTSL-AS, PTMR-AS K203636 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jkh USA, LLC. Cleared Aug 2021. https://www.510kdatabase.net/k210448/ 2021-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k210448-adhesive-electrode-fda-510k.jpg K210448 - Adhesive Electrode K210448 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shaoxing Yingtuo Healthcare Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k210956/ 2021-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k210956-kubtec-mozart-xpert42-fda-510k.jpg K210956 - Kubtec Mozart (XPERT42) K210956 is a FDA 510(k) cleared radiology medical device. Manufacturer: Kub Technologies, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k210957/ 2021-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k210957-kubec-xpert-80-radiography-system-fda-510k.jpg K210957 - Kubec Xpert 80 Radiography System K210957 is a FDA 510(k) cleared radiology medical device. Manufacturer: Kub Technologies, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k211449/ 2021-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k211449-triton-sacroiliac-joint-fixation-system-fda-510k.jpg K211449 - Triton™ Sacroiliac Joint Fixation System K211449 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Choice Spine, LLC. Cleared Aug 2021. https://www.510kdatabase.net/k211704/ 2021-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k211704-construx-mini-peek-spacer-fda-510k.jpg K211704 - CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer System, CONSTRUX Mini Ti Spacer System, FORZA PEEK Spacer System, FORZA PTC Spacer System, FORZA Ti Spacer System, FORZA XP Expandable Spacer System, Lonestar Cervical Standalone System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, PILLAR SA PTC Spacer System, SKYHAWK Lateral Interbody Fusion System K211704 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthofix, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k212083/ 2021-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k212083-tactoset-injectable-bone-substitute-fda-510k.jpg K212083 - Tactoset Injectable Bone Substitute K212083 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Anika Therapeutics, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k212145/ 2021-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k212145-dr-800-with-dsa-dr-800-fda-510k.jpg K212145 - DR 800 with DSA, DR 800 K212145 is a FDA 510(k) cleared radiology medical device. Manufacturer: Agfa N.V.. Cleared Aug 2021. https://www.510kdatabase.net/k212383/ 2021-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k212383-endonaut-fda-510k.jpg K212383 - EndoNaut K212383 is a FDA 510(k) cleared radiology medical device. Manufacturer: Therenva Sas. Cleared Aug 2021. https://www.510kdatabase.net/k210090/ 2021-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k210090-impulse-am-interbody-fusion-system-fda-510k.jpg K210090 - Impulse AM Interbody Fusion System K210090 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Degen Medical. Cleared Aug 2021. https://www.510kdatabase.net/k210805/ 2021-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k210805-ceribell-instant-eeg-headband-fda-510k.jpg K210805 - Ceribell Instant EEG Headband K210805 is a FDA 510(k) cleared neurology medical device. Manufacturer: Ceribell, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k211041/ 2021-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k211041-wrist-blood-pressure-monitor-model-fda-510k.jpg K211041 - Wrist Blood Pressure Monitor, Model Name:W203, Wrist Blood Pressure Monitor, Model Name:W202, Wrist Blood Pressure Monitor, Model Name:W1681 K211041 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Yuezhongxing Technology Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k211322/ 2021-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k211322-paratrooper-plantar-plate-repair-system-fda-510k.jpg K211322 - Paratrooper Plantar Plate Repair System K211322 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paragon 28, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k211630/ 2021-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k211630-vitek-2-ast-gram-negative-piperacillin-fda-510k.jpg K211630 - VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 µg/mL) K211630 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k211903/ 2021-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k211903-shoreline-threaded-truprofile-plate-fda-510k.jpg K211903 - Shoreline Threaded TruProfile® Plate K211903 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared Aug 2021. https://www.510kdatabase.net/k212054/ 2021-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k212054-senhance-surgical-system-fda-510k.jpg K212054 - Senhance Surgical System K212054 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Asensus Surgical, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k212070/ 2021-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k212070-kmti-s141-lumbar-interbody-fusion-system-fda-510k.jpg K212070 - KMTI S141 Lumbar Interbody Fusion System K212070 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Kyocera Medical Technologies, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k212103/ 2021-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k212103-starx-1-starx-2-starx-pro-1-and-starx-fda-510k.jpg K212103 - StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2 K212103 is a FDA 510(k) cleared radiology medical device. Manufacturer: Fona S.R.L. Cleared Aug 2021. https://www.510kdatabase.net/k203554/ 2021-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k203554-anyone-external-implant-system-fda-510k.jpg K203554 - AnyOne External Implant System K203554 is a FDA 510(k) cleared dental medical device. Manufacturer: Megagen Implant Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k211255/ 2021-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k211255-surgical-mask-fda-510k.jpg K211255 - Surgical Mask K211255 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Tianchang Kanghui Protective Products Co, Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k211390/ 2021-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k211390-nitrile-blue-powder-free-examination-fda-510k.jpg K211390 - Nitrile Blue Powder-free Examination Glove K211390 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cardinal Health200, LLC. Cleared Aug 2021. https://www.510kdatabase.net/k202746/ 2021-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k202746-surgical-mask-fda-510k.jpg K202746 - Surgical mask K202746 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ningbo Jingeao Electronics, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k202752/ 2021-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k202752-axs-vecta-46-intermediate-catheter-fda-510k.jpg K202752 - AXS Vecta 46 Intermediate Catheter K202752 is a FDA 510(k) cleared neurology medical device. Manufacturer: Stryker Neurovascular. Cleared Aug 2021. https://www.510kdatabase.net/k202781/ 2021-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k202781-neuspera-neurostimulation-system-nns-fda-510k.jpg K202781 - Neuspera Neurostimulation System (NNS) K202781 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neuspera Medical, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k202861/ 2021-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k202861-needle-stimulator-fda-510k.jpg K202861 - Needle Stimulator K202861 is a FDA 510(k) cleared neurology medical device. Manufacturer: Wuxi Jiajian Medical Instrument Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k203251/ 2021-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k203251-solopass-system-fda-510k.jpg K203251 - SOLOPASS System K203251 is a FDA 510(k) cleared neurology medical device. Manufacturer: Intravent Medical Partners, LP. Cleared Aug 2021. https://www.510kdatabase.net/k203613/ 2021-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k203613-enfit-reusable-enteral-syringe-fda-510k.jpg K203613 - ENFit Reusable Enteral Syringe K203613 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Shantou Wealy Medical Instrument Co.,Ltd. Cleared Aug 2021. https://www.510kdatabase.net/k203696/ 2021-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k203696-rbknee-fda-510k.jpg K203696 - RBknee K203696 is a FDA 510(k) cleared radiology medical device. Manufacturer: Radiobotics Aps. Cleared Aug 2021. https://www.510kdatabase.net/k210047/ 2021-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k210047-stiletto-extended-dwell-catheter-fda-510k.jpg K210047 - Stiletto Extended Dwell Catheter K210047 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Piper Access, LLC. Cleared Aug 2021. https://www.510kdatabase.net/k210122/ 2021-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k210122-sterile-bioabsorbable-bone-screw-fda-510k.jpg K210122 - Sterile Bioabsorbable bone screw (Bioabsorbable ACL screw) K210122 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonic Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k210373/ 2021-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k210373-clear-aligners-fda-510k.jpg K210373 - Clear Aligners K210373 is a FDA 510(k) cleared dental medical device. Manufacturer: Shenzhen Yinuo Dental Technology Co.Ltd. Cleared Aug 2021. https://www.510kdatabase.net/k210502/ 2021-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k210502-trevo-nxt-provue-retriever-fda-510k.jpg K210502 - Trevo NXT ProVue Retriever K210502 is a FDA 510(k) cleared neurology medical device. Manufacturer: Stryker Neurovascular. Cleared Aug 2021. https://www.510kdatabase.net/k210530/ 2021-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k210530-wolf-thrombectomy-system-6f-fda-510k.jpg K210530 - WOLF Thrombectomy System, 6F K210530 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Devoro Medical, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k210610/ 2021-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k210610-primetaper-ev-dental-implant-fda-510k.jpg K210610 - PrimeTaper EV Dental Implant K210610 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k210676/ 2021-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k210676-xstat-30-pouch-fda-510k.jpg K210676 - XSTAT 30 Pouch K210676 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Revmedx, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k211373/ 2021-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k211373-somatom-goplatform-scanners-somatom-fda-510k.jpg K211373 - SOMATOM go.Platform Scanners - SOMATOM go.Now, go.Up, go.All, go.Top, SOMATOM X. Platform Scanners - SOMATOM X.cite and SOMATOM X.ceed, Scan&GO Software K211373 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k211413/ 2021-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k211413-bee-plif-cage-fda-510k.jpg K211413 - BEE PLIF Cage K211413 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: NGMedical GmbH. Cleared Aug 2021. https://www.510kdatabase.net/k211524/ 2021-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k211524-logiq-e10s-logiq-fortis-fda-510k.jpg K211524 - LOGIQ E10s, LOGIQ Fortis K211524 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Aug 2021. https://www.510kdatabase.net/k211684/ 2021-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k211684-pillcam-sb-3-capsule-endoscopy-system-fda-510k.jpg K211684 - PillCam SB 3 capsule endoscopy system, PillCam Software 9.0E K211684 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Given Imaging Ltd. (Medtronic). Cleared Aug 2021. https://www.510kdatabase.net/k211995/ 2021-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k211995-sonendo-filling-material-5c-fda-510k.jpg K211995 - Sonendo Filling Material 5C K211995 is a FDA 510(k) cleared dental medical device. Manufacturer: Sonendo, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k212004/ 2021-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k212004-myospect-myospect-es-fda-510k.jpg K212004 - MyoSPECT, MyoSpect ES K212004 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Aug 2021. https://www.510kdatabase.net/k212023/ 2021-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k212023-virage-navigation-system-fda-510k.jpg K212023 - Virage Navigation System K212023 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer Biomet Spine, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k212038/ 2021-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k212038-kj-iva-acif-dlif-plif-tlif-alif-peek-fda-510k.jpg K212038 - K&J IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage K212038 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: K&J Consulting Corporation. Cleared Aug 2021. https://www.510kdatabase.net/k212345/ 2021-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k212345-acqmap-high-resolution-imaging-and-fda-510k.jpg K212345 - AcQMap High Resolution Imaging and Mapping System K212345 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Acutus Medical, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/den200064/ 2021-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/den200064-canary-tibial-extension-with-canary-fda-510k.jpg DEN200064 - Canary Tibial Extension with Canary Health Implanted Reporting Processor (CHIRP) System DEN200064 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Canary Medical, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k200230/ 2021-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k200230-aptiva-celiac-disease-igg-reagent-fda-510k.jpg K200230 - Aptiva Celiac Disease IgG Reagent K200230 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k200748/ 2021-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k200748-visby-medical-sexual-health-fda-510k.jpg K200748 - Visby Medical Sexual Health K200748 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Visby Medical. Cleared Aug 2021. https://www.510kdatabase.net/k202802/ 2021-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k202802-tt-electric-breast-pump-tt-double-fda-510k.jpg K202802 - TT Electric Breast Pump, TT Double Electric Breast Pump K202802 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Wuxi Xinzhongrui Baby Supplies Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k202831/ 2021-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k202831-the-imask-childs-face-mask-fda-510k.jpg K202831 - The iMask Child's Face Mask K202831 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Pac-Dent, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k202952/ 2021-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k202952-amber-mill-q-series-amber-mill-direct-fda-510k.jpg K202952 - Amber Mill Q Series & Amber Mill Direct Series K202952 is a FDA 510(k) cleared dental medical device. Manufacturer: Hass Corp.. Cleared Aug 2021. https://www.510kdatabase.net/k210131/ 2021-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k210131-comfortguard-surgical-isolation-gown-fda-510k.jpg K210131 - ComfortGuard Surgical Isolation Gown K210131 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Gri-Alleset, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k210288/ 2021-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k210288-disposable-manual-resuscitator-fda-510k.jpg K210288 - Disposable Manual Resuscitator K210288 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Xiamen Compower Medical Tech. Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k210745/ 2021-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k210745-heel-incision-safety-lancet-fda-510k.jpg K210745 - Heel Incision Safety Lancet K210745 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: SteriLance Medical (Suzhou), Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k210898/ 2021-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k210898-disposable-nitrile-examination-gloves-fda-510k.jpg K210898 - Disposable Nitrile Examination Gloves (Powder Free, Purple-Blue, Blue) K210898 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Tangshan Lanhai Medical Supplies Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k210991/ 2021-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k210991-disposable-sterile-syringe-disposable-fda-510k.jpg K210991 - Disposable Sterile Syringe, Disposable Sterile Syringe with Needle K210991 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guangdong Antmed Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k211240/ 2021-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k211240-vipercross-support-catheters-fda-510k.jpg K211240 - ViperCross Support Catheters K211240 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cardiovascular Systems, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k211634/ 2021-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k211634-hypodermic-needle-pro-edge-safety-device-fda-510k.jpg K211634 - Hypodermic Needle-Pro EDGE Safety Device K211634 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Smiths Medical Asd, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k212048/ 2021-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k212048-ion-endoluminal-system-ion-fully-fda-510k.jpg K212048 - Ion Endoluminal System (Ion Fully Articulating Catheter), Ion Endoluminal System (Ion Peripheral Vision Probe) K212048 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k212355/ 2021-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k212355-checkpoint-guardian-intraoperative-fda-510k.jpg K212355 - Checkpoint Guardian Intraoperative Lead, Medium, Checkpoint Guardian Intraoperative Lead, Large K212355 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Checkpoint Surgical. Cleared Aug 2021. https://www.510kdatabase.net/k202148/ 2021-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k202148-e-fit-infinity-system-ef-2090-fda-510k.jpg K202148 - E-Fit Infinity System (EF-2090 Controller and EF-100 Unit) K202148 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fit-Pro , Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k202916/ 2021-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k202916-balloon-guiding-catheter-fda-510k.jpg K202916 - Balloon Guiding Catheter K202916 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shanghai Heartcare Medical Technology Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k203344/ 2021-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k203344-premilled-titanium-block-system-fda-510k.jpg K203344 - Premilled Titanium Block System K203344 is a FDA 510(k) cleared dental medical device. Manufacturer: Innobiosurg Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k203357/ 2021-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k203357-hvt-20-fda-510k.jpg K203357 - HVT 2.0 K203357 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Vapotherm, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k210790/ 2021-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k210790-lateralized-and-augmented-baseplates-fda-510k.jpg K210790 - Lateralized and Augmented Baseplates K210790 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Fx Shoulder USA, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k210792/ 2021-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k210792-auxein-nailing-system-fda-510k.jpg K210792 - Auxein Nailing System K210792 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Auxein Medical Private Limited. Cleared Aug 2021. https://www.510kdatabase.net/k210838/ 2021-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k210838-prowler-select-plus-fda-510k.jpg K210838 - PROWLER SELECT PLUS K210838 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medos International SARL. Cleared Aug 2021. https://www.510kdatabase.net/k210936/ 2021-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k210936-elvie-stride-fda-510k.jpg K210936 - Elvie Stride K210936 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Chiaro Technology Limited. Cleared Aug 2021. https://www.510kdatabase.net/k211362/ 2021-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k211362-scar-3-fda-510k.jpg K211362 - SCAR 3 K211362 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: El.En Electronic Engineering Spa. Cleared Aug 2021. https://www.510kdatabase.net/k211444/ 2021-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k211444-cellfx-system-fda-510k.jpg K211444 - CellFX System K211444 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Pulse Biosciences, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k211451/ 2021-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k211451-disposable-surgical-mask-non-sterile-fda-510k.jpg K211451 - Disposable Surgical Mask (non sterile) K211451 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Qinhuangdao Taizhi Medical Technology Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k211500/ 2021-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k211500-amsco-600-medium-steam-sterilizer-fda-510k.jpg K211500 - AMSCO 600 Medium Steam Sterilizer K211500 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Aug 2021. https://www.510kdatabase.net/k211609/ 2021-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k211609-attune-medial-stabilized-ms-fixed-fda-510k.jpg K211609 - ATTUNE Medial Stabilized (MS) Fixed Bearing (FB) Insert K211609 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Ireland UC. Cleared Aug 2021. https://www.510kdatabase.net/k211616/ 2021-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k211616-excelsiushub-fda-510k.jpg K211616 - ExcelsiusHub K211616 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k212051/ 2021-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k212051-rfa-1717dig-rfa-1717dic-fda-510k.jpg K212051 - RFA-1717DIG, RFA-1717DIC K212051 is a FDA 510(k) cleared radiology medical device. Manufacturer: Astel, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k212134/ 2021-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k212134-diagnostic-x-ray-systemplx5200a-fda-510k.jpg K212134 - Diagnostic X-ray System/PLX5200A K212134 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nanjing Perlove Medical Equipment Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k212323/ 2021-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k212323-instinct-plus-endoscopic-clipping-device-fda-510k.jpg K212323 - Instinct Plus Endoscopic Clipping Device K212323 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Wilson-Cook Medical, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k201157/ 2021-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k201157-prime-biofoam-multi-hole-shells-fda-510k.jpg K201157 - Prime BIOFOAM® Multi-Hole Shells K201157 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Microport Orthopedics, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k203739/ 2021-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k203739-elan-4-electro-motor-system-fda-510k.jpg K203739 - ELAN 4 Electro Motor System K203739 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k210464/ 2021-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k210464-auto-disable-syringe-fda-510k.jpg K210464 - Auto Disable Syringe K210464 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Anhui Tiankang Medical Technology Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k210619/ 2021-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k210619-skr-3000-fda-510k.jpg K210619 - SKR 3000 K210619 is a FDA 510(k) cleared radiology medical device. Manufacturer: Konica Minolta, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k210674/ 2021-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k210674-shoulder-pacemaker-fda-510k.jpg K210674 - Shoulder Pacemaker K210674 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Ncs Lab Srl. Cleared Aug 2021. https://www.510kdatabase.net/k210844/ 2021-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k210844-dreamwear-silicone-pillows-mask-fda-510k.jpg K210844 - DreamWear Silicone Pillows Mask K210844 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k210897/ 2021-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k210897-disposable-nitrile-examination-gloves-fda-510k.jpg K210897 - Disposable Nitrile Examination Gloves K210897 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shandong DS Safety Technology Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k211501/ 2021-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k211501-advantage-c-peek-cervical-lnterbody-fda-510k.jpg K211501 - Advantage-C PEEK Cervical lnterbody Fusion Device K211501 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Lntelivation, LLC. Cleared Aug 2021. https://www.510kdatabase.net/k211515/ 2021-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k211515-nitrile-examination-gloves-fda-510k.jpg K211515 - Nitrile Examination Gloves K211515 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Beijing Reagent Latex Products Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k211516/ 2021-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k211516-disposable-vinyl-nitrile-synthetic-fda-510k.jpg K211516 - Disposable Vinyl Nitrile Synthetic Gloves Powder Free K211516 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Tangshan Hongyun Plastic Products Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k212027/ 2021-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k212027-turbohawk-plus-directional-atherectomy-fda-510k.jpg K212027 - TurboHawk Plus Directional Atherectomy System K212027 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k200657/ 2021-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k200657-smartguard-anti-snoring-device-fda-510k.jpg K200657 - SmartGuard Anti-Snoring Device K200657 is a FDA 510(k) cleared dental medical device. Manufacturer: Smartguard Rx, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k201400/ 2021-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k201400-npsims-negative-pressure-surgical-fda-510k.jpg K201400 - npSIMS Negative Pressure Surgical Incision Management System™ (npSIMS)™ K201400 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aatru Medical, LLC. Cleared Aug 2021. https://www.510kdatabase.net/k202745/ 2021-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k202745-disposable-medical-face-mask-fda-510k.jpg K202745 - Disposable medical face mask K202745 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ningbo Jingeao Electronics, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k203396/ 2021-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k203396-deka-smartperio-fda-510k.jpg K203396 - DEKA SMARTPERIO K203396 is a FDA 510(k) cleared dental medical device. Manufacturer: El.En Electronic Engineering Spa. Cleared Aug 2021. https://www.510kdatabase.net/k211793/ 2021-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k211793-ezortho-fda-510k.jpg K211793 - EzOrtho K211793 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ewoosoft Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k212039/ 2021-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k212039-clareon-monarch-iv-iol-delivery-system-fda-510k.jpg K212039 - CLAREON MONARCH IV IOL Delivery System K212039 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Alcon Laboratories, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k212105/ 2021-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k212105-6543z-4386z-4343z-4343zf-3543z-3543zf-fda-510k.jpg K212105 - 6543Z, 4386Z, 4343Z, 4343ZF, 3543Z, 3543ZF, 3030Z, 3025Z, 3025ZF K212105 is a FDA 510(k) cleared radiology medical device. Manufacturer: Pzmedical Technology Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k212324/ 2021-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k212324-renovocath-fda-510k.jpg K212324 - RenovoCath K212324 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Renovorx, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k212367/ 2021-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k212367-imris-imri-3t-v-fda-510k.jpg K212367 - IMRIS iMRI 3T V K212367 is a FDA 510(k) cleared radiology medical device. Manufacturer: Deerfield Imaging, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/den210003/ 2021-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/den210003-suretune4-software-fda-510k.jpg DEN210003 - SureTune4 Software DEN210003 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Neuromodulation. Cleared Aug 2021. https://www.510kdatabase.net/k202532/ 2021-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k202532-disposable-surgical-gowns-fda-510k.jpg K202532 - Disposable Surgical Gowns K202532 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Anhui Medpurest Medical Technology Co.,Ltd. Cleared Aug 2021. https://www.510kdatabase.net/k201857/ 2021-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k201857-powder-free-nitrile-examination-glove-fda-510k.jpg K201857 - Powder Free Nitrile Examination Glove Black and Dual Color White-Blue K201857 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Careplus (M) Sdn Bhd. Cleared Aug 2021. https://www.510kdatabase.net/k202670/ 2021-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k202670-nam-illumination-probe-with-chopper-fda-510k.jpg K202670 - Nam illumination probe with chopper K202670 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Oculight , Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k202705/ 2021-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k202705-prime-and-dynasty-additive-fda-510k.jpg K202705 - Prime and DYNASTY® Additive Manufacturing Shells K202705 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Microport Orthopedics, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k203029/ 2021-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k203029-auxilock-titanium-interference-screw-fda-510k.jpg K203029 - Auxilock Titanium Interference Screw K203029 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Auxein Medical Private Limited. Cleared Aug 2021. https://www.510kdatabase.net/k203486/ 2021-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k203486-otoplan-fda-510k.jpg K203486 - Otoplan K203486 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Cascination AG. Cleared Aug 2021. https://www.510kdatabase.net/k203607/ 2021-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k203607-moss-vrs-spinal-system-fda-510k.jpg K203607 - MOSS VRS Spinal System K203607 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biedermann Motech GmbH & Co. KG. Cleared Aug 2021. https://www.510kdatabase.net/k203622/ 2021-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k203622-medical-gloves-fda-510k.jpg K203622 - Medical Gloves K203622 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Beijing Biosis Healing Biolog Ical Technology Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k203705/ 2021-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k203705-latex-examination-glove-powder-free-fda-510k.jpg K203705 - Latex Examination Glove, Powder free with Protein Content Labeling Claim (50 ug/g or less of total extractable Protein) K203705 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Careplus (M) Sdn Bhd. Cleared Aug 2021. https://www.510kdatabase.net/k203790/ 2021-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k203790-gem-premier-5000-fda-510k.jpg K203790 - GEM Premier 5000 K203790 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Aug 2021. https://www.510kdatabase.net/k210533/ 2021-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k210533-inset-reverse-total-shoulder-system-fda-510k.jpg K210533 - Inset Reverse Total Shoulder System K210533 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Shoulder Innovations, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k210800/ 2021-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k210800-io-expandable-lumbar-interbody-fusion-fda-510k.jpg K210800 - IO Expandable Lumbar Interbody Fusion System K210800 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: MiRus, LLC. Cleared Aug 2021. https://www.510kdatabase.net/k210887/ 2021-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k210887-altus-spine-sochi-oct-spinal-system-fda-510k.jpg K210887 - Altus Spine Sochi OCT Spinal System K210887 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Altus Partners, LLC. Cleared Aug 2021. https://www.510kdatabase.net/k211194/ 2021-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k211194-molekule-air-pro-fda-510k.jpg K211194 - Molekule Air Pro K211194 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Molekule, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k211527/ 2021-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k211527-exo-iris-fda-510k.jpg K211527 - Exo Iris K211527 is a FDA 510(k) cleared radiology medical device. Manufacturer: Exo Imaging, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k211551/ 2021-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k211551-wishbone-ha-fda-510k.jpg K211551 - Wishbone HA K211551 is a FDA 510(k) cleared dental medical device. Manufacturer: Wishbone SA. Cleared Aug 2021. https://www.510kdatabase.net/k211699/ 2021-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k211699-nitrile-exam-gloves-powder-free-blue-fda-510k.jpg K211699 - Nitrile Exam Gloves, Powder Free, Blue K211699 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hengchang (Dongying) Medical Technology Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k211757/ 2021-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k211757-simplify-disc-fda-510k.jpg K211757 - Simplify Disc K211757 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nuvasive, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k211791/ 2021-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k211791-ez3d-ie3-fda-510k.jpg K211791 - Ez3D-i/E3 K211791 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ewoosoft Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k211846/ 2021-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k211846-discovery-mi-gen2-fda-510k.jpg K211846 - Discovery MI Gen2 K211846 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems, LLC. Cleared Aug 2021. https://www.510kdatabase.net/k211895/ 2021-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k211895-bc-reflex-uni-knee-system-fda-510k.jpg K211895 - BC Reflex Uni Knee System K211895 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Bodycad Laboratories, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k211916/ 2021-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k211916-ips-emax-one-fda-510k.jpg K211916 - IPS e.max One K211916 is a FDA 510(k) cleared dental medical device. Manufacturer: Ivoclar Vivadent, AG. Cleared Aug 2021. https://www.510kdatabase.net/k212294/ 2021-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k212294-ethos-treatment-management-ethos-fda-510k.jpg K212294 - Ethos Treatment Management, Ethos Treatment Planning K212294 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k212297/ 2021-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k212297-omni-foot-and-ankle-plating-system-fda-510k.jpg K212297 - Omni Foot and Ankle Plating System K212297 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Extremity Medical, LLC. Cleared Aug 2021. https://www.510kdatabase.net/den190056/ 2021-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/den190056-advia-centaur-enhanced-liver-fibrosis-fda-510k.jpg DEN190056 - ADVIA Centaur Enhanced Liver Fibrosis (ELF) DEN190056 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k202425/ 2021-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k202425-surgilattice-scaffold-fda-510k.jpg K202425 - SurgiLattice scaffold K202425 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Tepha, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k202652/ 2021-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k202652-servator-p-salf-solution-with-tham-fda-510k.jpg K202652 - Servator P SALF Solution with THAM K202652 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: S.A.L.F. Spa. Cleared Aug 2021. https://www.510kdatabase.net/k202836/ 2021-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k202836-gx-navigation-instrument-system-fda-510k.jpg K202836 - GX Navigation Instrument System K202836 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k203633/ 2021-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k203633-enteral-extension-sets-fda-510k.jpg K203633 - Enteral Extension Sets K203633 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: GBUK Group, Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k210203/ 2021-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k210203-mmrna-appliance-fda-510k.jpg K210203 - mmRNA appliance K210203 is a FDA 510(k) cleared dental medical device. Manufacturer: Vivos Therapeutics, Inc. (Formerly Vivos Biotechnologies, I). Cleared Aug 2021. https://www.510kdatabase.net/k210256/ 2021-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k210256-cirx-r-surgical-mask-fda-510k.jpg K210256 - CiRx (R) Surgical Mask K210256 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ningbo Shun YE Medical Company, Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k210317/ 2021-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k210317-apogee-1000-apogee-1000neo-apogee-fda-510k.jpg K210317 - Apogee 1000/ Apogee 1000Neo/ Apogee 1000Lite/ Apogee 1000Exp/ Apogee 1000B/W / Apogee 1U/ Apogee 1T/ Apogee 1G Digital Color Doppler Ultrasound Imaging System K210317 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui). Cleared Aug 2021. https://www.510kdatabase.net/k210362/ 2021-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k210362-s-clean-pre-milled-abutment-fda-510k.jpg K210362 - s-Clean Pre-Milled Abutment K210362 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentis Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k210698/ 2021-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k210698-ecoma-level-2-disposable-surgical-mask-fda-510k.jpg K210698 - ECOMA Level 2 Disposable Surgical Mask with Ear Loops K210698 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Xianning Eco Medical Articles Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k210749/ 2021-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k210749-empty-eva-bag-fda-510k.jpg K210749 - Empty EVA Bag K210749 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Haemotronic S.P.A.. Cleared Aug 2021. https://www.510kdatabase.net/k211066/ 2021-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k211066-sovereign-america-surgical-mask-model-fda-510k.jpg K211066 - Sovereign America Surgical Mask, Model Number: 2000SM2, Sovereign America Surgical Mask, Model Number: 2000SM3 K211066 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Homtex, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k211104/ 2021-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k211104-airseal-dv-solution-airseal-cannula-fda-510k.jpg K211104 - AirSeal® dV Solution- AirSeal® Cannula Cap and AirSeal® Bifurcated Filtered Tube Set K211104 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Conmed Corporation. Cleared Aug 2021. https://www.510kdatabase.net/k211319/ 2021-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k211319-purism-non-sterile-powder-free-nitrile-fda-510k.jpg K211319 - Purism Non-Sterile Powder Free Nitrile Examination Gloves K211319 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Dezhou Purism Medical Technology Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k211328/ 2021-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k211328-eidon-fa-eidon-eidon-af-eidon-uwfl-fda-510k.jpg K211328 - EIDON FA, EIDON, EIDON AF, EIDON UWFL K211328 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Centervue S.P.A.. Cleared Aug 2021. https://www.510kdatabase.net/k211462/ 2021-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k211462-disposable-ear-loop-medical-face-mask-fda-510k.jpg K211462 - Disposable Ear-loop Medical Face Mask, Disposable Tie-On Medical Face Mask K211462 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Xiantao S&J Protective Products Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k211576/ 2021-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k211576-wyz-surgical-mask-fda-510k.jpg K211576 - WYZ Surgical Mask K211576 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wyz Medical Supplies, LLC. Cleared Aug 2021. https://www.510kdatabase.net/k211584/ 2021-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k211584-oral-surgery-contra-fda-510k.jpg K211584 - Oral Surgery Contra K211584 is a FDA 510(k) cleared dental medical device. Manufacturer: Nakanishi, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k211620/ 2021-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k211620-biodegradable-powder-free-latex-fda-510k.jpg K211620 - Biodegradable Powder Free Latex Examination Gloves Natural, Blue, Black and Green Colors with protein content labeling claim (50 micrograms or less) K211620 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shen Wei (Usa), Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k212185/ 2021-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k212185-golden-isles-pedicle-screw-system-fda-510k.jpg K212185 - Golden Isles Pedicle Screw System K212185 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Intelivation, LLC. Cleared Aug 2021. https://www.510kdatabase.net/k212296/ 2021-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k212296-distal-cap-model-dh-32en-distal-cap-fda-510k.jpg K212296 - Distal Cap Model DH-32EN, Distal Cap Model DH-17EN2 K212296 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fujifilm Corporation. Cleared Aug 2021. https://www.510kdatabase.net/k212304/ 2021-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k212304-callaly-tampliner-super-plus-absorbency-fda-510k.jpg K212304 - Callaly Tampliner (super plus absorbency) K212304 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Calla Lily Personal Care, Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/den210013/ 2021-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/den210013-osteoprobe-fda-510k.jpg DEN210013 - OsteoProbe DEN210013 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Active Life Scientific, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k203227/ 2021-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k203227-elecsys-hcg-stat-fda-510k.jpg K203227 - Elecsys HCG STAT K203227 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Aug 2021. https://www.510kdatabase.net/k210318/ 2021-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k210318-apogee-6500apogee-6300apogee-6200-fda-510k.jpg K210318 - Apogee 6500,Apogee 6300,Apogee 6200 Digital Color Doppler Ultrasound Imaging System K210318 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui). Cleared Aug 2021. https://www.510kdatabase.net/k210971/ 2021-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k210971-enteraloc-flow-fda-510k.jpg K210971 - EnteraLoc Flow K210971 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Vonco Products. Cleared Aug 2021. https://www.510kdatabase.net/k211233/ 2021-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k211233-hailie-sensor-nf0109-fda-510k.jpg K211233 - Hailie Sensor NF0109 K211233 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Adherium (Nz), Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k211454/ 2021-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k211454-surgical-mask-fda-510k.jpg K211454 - Surgical mask K211454 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Xingtong Biotechnology Group Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k211513/ 2021-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k211513-sam-x1-long-duration-ultrasound-device-fda-510k.jpg K211513 - sam X1 Long Duration Ultrasound Device K211513 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: ZetrOZ Systems, LLC. Cleared Aug 2021. https://www.510kdatabase.net/k211631/ 2021-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k211631-surgical-face-mask-fda-510k.jpg K211631 - Surgical Face Mask K211631 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Macheng Thimble Technology Investment Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k211813/ 2021-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k211813-triton-fda-510k.jpg K211813 - Triton K211813 is a FDA 510(k) cleared dental medical device. Manufacturer: Inter-Med / Vista Dental. Cleared Aug 2021. https://www.510kdatabase.net/k211957/ 2021-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k211957-quartex-occipito-cervico-thoracic-fda-510k.jpg K211957 - QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments K211957 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k212097/ 2021-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k212097-disposable-medical-surgical-mask-fda-510k.jpg K212097 - Disposable medical surgical mask K212097 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hebei Titans Hongsen Medical Technology Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k212322/ 2021-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k212322-cellvizio-ive-system-with-confocal-fda-510k.jpg K212322 - Cellvizio I.V.E. system with Confocal Miniprobes K212322 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Mauna Kea Technologies. Cleared Aug 2021. https://www.510kdatabase.net/k201573/ 2021-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k201573-brain-perfusion-bp-application-fda-510k.jpg K201573 - Brain Perfusion (BP) application K201573 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Aug 2021. https://www.510kdatabase.net/k203089/ 2021-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k203089-dexcom-g6-glucose-program-continuous-fda-510k.jpg K203089 - Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System K203089 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dexcom, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k203820/ 2021-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k203820-aspivix-v11-cervical-suction-tenaculum-fda-510k.jpg K203820 - ASPIVIX v1.1 Cervical Suction Tenaculum K203820 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Aspivix SA. Cleared Aug 2021. https://www.510kdatabase.net/k210201/ 2021-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k210201-deep-transcranial-magnetic-stimulation-fda-510k.jpg K210201 - Deep Transcranial Magnetic Stimulation (DTMS) System K210201 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainsway , Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k210998/ 2021-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k210998-rosa-hip-system-fda-510k.jpg K210998 - ROSA Hip System K210998 is a FDA 510(k) cleared radiology medical device. Manufacturer: Orthosoft D/B/A Zimmer Cas. Cleared Aug 2021. https://www.510kdatabase.net/k211376/ 2021-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k211376-starband-fda-510k.jpg K211376 - STARband K211376 is a FDA 510(k) cleared neurology medical device. Manufacturer: Orthomerica Products, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k211671/ 2021-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k211671-journey-ii-mid-level-tibial-inserts-fda-510k.jpg K211671 - Journey II Mid-Level Tibial Inserts K211671 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k211708/ 2021-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k211708-disposable-medical-nitrile-gloves-fda-510k.jpg K211708 - Disposable Medical Nitrile Gloves K211708 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Health-Peace Medical Technology Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k201094/ 2021-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k201094-imap-3d-mapping-navigation-system-imap-fda-510k.jpg K201094 - iMap 3D Mapping & Navigation System (iMap System) K201094 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cardionxt, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k202636/ 2021-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k202636-metallic-fabric-electrodes-fda-510k.jpg K202636 - Metallic Fabric Electrodes K202636 is a FDA 510(k) cleared neurology medical device. Manufacturer: Guangzhou Xinbo Electronic Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k203236/ 2021-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k203236-rhino-health-non-sterile-powder-free-fda-510k.jpg K203236 - Rhino Health Non-Sterile, Powder-free Nitrile Exam Glove K203236 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Rhino Health, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k210569/ 2021-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k210569-disposable-monopolar-laparoscopic-fda-510k.jpg K210569 - Disposable Monopolar Laparoscopic Shafts and Reusable Handles K210569 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Dannik, LLC. Cleared Aug 2021. https://www.510kdatabase.net/k210695/ 2021-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k210695-cpm-medical-consultants-tibial-fda-510k.jpg K210695 - CPM Medical Consultants Tibial Revision Knee System K210695 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Cpm Medical Consultants, LLC. Cleared Aug 2021. https://www.510kdatabase.net/k210841/ 2021-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k210841-nuvent-eustachian-tube-dilation-balloon-fda-510k.jpg K210841 - NuVent Eustachian Tube Dilation Balloon K210841 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Medtronic Xomed, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k211294/ 2021-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k211294-multi-link-x2-ecg-cable-and-leadwire-fda-510k.jpg K211294 - Multi-Link X2 ECG Cable and Leadwire System K211294 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vyaire Medical, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k211654/ 2021-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k211654-penumbra-system-reperfusion-catheter-fda-510k.jpg K211654 - Penumbra System (Reperfusion Catheter RED 72) K211654 is a FDA 510(k) cleared neurology medical device. Manufacturer: Penumbra, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k211703/ 2021-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k211703-insignia-hip-stem-fda-510k.jpg K211703 - Insignia Hip Stem K211703 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Orthopaedics. Cleared Aug 2021. https://www.510kdatabase.net/k212066/ 2021-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k212066-adena-zina-system-fda-510k.jpg K212066 - Adena-Zina System K212066 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Shanghai Sanyou Medical Co, Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k212230/ 2021-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k212230-truspect-radiological-image-processing-fda-510k.jpg K212230 - TruSPECT Radiological Image Processing Station K212230 is a FDA 510(k) cleared radiology medical device. Manufacturer: Spectrum Dynamics Medical, Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k210381/ 2021-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k210381-iv-administration-set-fda-510k.jpg K210381 - I.V. Administration Set K210381 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bq Plus Medical Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k192823/ 2021-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k192823-mega-tms-fda-510k.jpg K192823 - MEGA-TMS K192823 is a FDA 510(k) cleared neurology medical device. Manufacturer: Soterix Medical, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k200913/ 2021-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k200913-clearblue-early-digital-pregnancy-test-fda-510k.jpg K200913 - Clearblue® Early Digital Pregnancy Test K200913 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Spd Swiss Precision Diagnostics GmbH. Cleared Aug 2021. https://www.510kdatabase.net/k202279/ 2021-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k202279-insignis-subcutaneous-needle-sets-fda-510k.jpg K202279 - Insignis Subcutaneous Needle Sets K202279 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Innovative Health Sciences, LLC. Cleared Aug 2021. https://www.510kdatabase.net/k203693/ 2021-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k203693-nisus-touch-negative-pressure-wound-fda-510k.jpg K203693 - Nisus Touch Negative Pressure Wound Therapy Pump K203693 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cork Medical Products, LLC. Cleared Aug 2021. https://www.510kdatabase.net/k203817/ 2021-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k203817-tyber-medical-anatomical-plating-system-fda-510k.jpg K203817 - Tyber Medical Anatomical Plating System K203817 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tyber Medical, LLC. Cleared Aug 2021. https://www.510kdatabase.net/k210336/ 2021-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k210336-neodent-implant-system-zirconia-fda-510k.jpg K210336 - Neodent Implant System - Zirconia Implant System K210336 is a FDA 510(k) cleared dental medical device. Manufacturer: Jjgc Industria E Comercio DE Materiais Dentarios S.A.. Cleared Aug 2021. https://www.510kdatabase.net/k210671/ 2021-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k210671-digital-blood-pressure-monitor-wbp-fda-510k.jpg K210671 - Digital Blood Pressure Monitor WBP Series, including: WBP101, WBP102, WBP103, WBP104, WBP105, WBP106, WBP107 K210671 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Weony (Shenzhen) Technology Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k210858/ 2021-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k210858-vitros-chemistry-products-phbr-slides-fda-510k.jpg K210858 - VITROS Chemistry Products PHBR Slides K210858 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Ortho-Clinical Diagnostics, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k210958/ 2021-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k210958-i-stat-chem8-cartridge-with-the-i-stat-fda-510k.jpg K210958 - i-STAT CHEM8+ cartridge with the i-STAT 1 System K210958 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Point of Care, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k211383/ 2021-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k211383-nflk-2501-portable-x-ray-unit-fda-510k.jpg K211383 - NFLK-2501 Portable X-ray Unit K211383 is a FDA 510(k) cleared radiology medical device. Manufacturer: Neuf, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k211519/ 2021-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k211519-every-cycle-reusable-tampon-applicator-fda-510k.jpg K211519 - Every Cycle Reusable Tampon Applicator K211519 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Cycle, LLC. Cleared Aug 2021. https://www.510kdatabase.net/k211563/ 2021-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k211563-pitch-patchs-fda-510k.jpg K211563 - Pitch-Patchs K211563 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Xiros, Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k211575/ 2021-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k211575-omnipod-insulin-management-system-fda-510k.jpg K211575 - Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System K211575 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Insulet Corporation. Cleared Aug 2021. https://www.510kdatabase.net/k211588/ 2021-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k211588-caretaker-platform-vitalstream-fda-510k.jpg K211588 - Caretaker Platform, VitalStream Platform, CT5 K211588 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Caretaker Medical. Cleared Aug 2021. https://www.510kdatabase.net/k211777/ 2021-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k211777-arco-fp-s-fda-510k.jpg K211777 - ARCO FP-S K211777 is a FDA 510(k) cleared radiology medical device. Manufacturer: A.T.S. Applicazione Tecnologie Speciali S.R.L.. Cleared Aug 2021. https://www.510kdatabase.net/k211860/ 2021-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k211860-powder-free-nitrile-patient-fda-510k.jpg K211860 - Powder Free Nitrile Patient Examination Gloves, Blue Color K211860 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Anhui Powerguard Technology Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k211969/ 2021-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k211969-emm-ultrasonic-transducer-cover-fda-510k.jpg K211969 - EMM Ultrasonic Transducer Cover K211969 is a FDA 510(k) cleared radiology medical device. Manufacturer: Exact Medical Manufacturing. Cleared Aug 2021. https://www.510kdatabase.net/k212206/ 2021-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k212206-jot-dx-insertable-cardiac-monitor-fda-510k.jpg K212206 - Jot Dx Insertable Cardiac Monitor K212206 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott (St. Jude Medical). Cleared Aug 2021. https://www.510kdatabase.net/k212228/ 2021-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k212228-watchman-fxd-curve-access-system-fda-510k.jpg K212228 - WATCHMAN FXD Curve Access System K212228 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Aug 2021. https://www.510kdatabase.net/k212229/ 2021-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k212229-white-endoseal-mta-fda-510k.jpg K212229 - White Endoseal MTA K212229 is a FDA 510(k) cleared dental medical device. Manufacturer: Maruchi. Cleared Aug 2021. https://www.510kdatabase.net/k201630/ 2021-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k201630-assuretech-doa-dipstick-screen-panel-fda-510k.jpg K201630 - AssureTech DOA Dipstick Screen Panel Tests, AssureTech DOA Integrated Cup Tests K201630 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Assure Tech. (Hangzhou) Co, Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k203363/ 2021-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k203363-crosser-iq-cto-recanalization-system-fda-510k.jpg K203363 - Crosser iQ CTO Recanalization System K203363 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k210327/ 2021-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k210327-first-sign-multi-drug-test-dip-card-fda-510k.jpg K210327 - First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card, First Sign Multi-Drug Screen Test Cup K210327 is a FDA 510(k) cleared toxicology medical device. Manufacturer: W.H.P.M., Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k210510/ 2021-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k210510-disposable-surgical-gown-fda-510k.jpg K210510 - Disposable Surgical Gown K210510 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shandong Zhushi Pharmaceutical Group Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k210661/ 2021-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k210661-sc-hemodialysis-machine-sc-dialysate-fda-510k.jpg K210661 - SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tubeset K210661 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quanta Dialysis Technologies, Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k210912/ 2021-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k210912-excelsius3d-fda-510k.jpg K210912 - Excelsius3D K210912 is a FDA 510(k) cleared radiology medical device. Manufacturer: Globus Medical, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k210946/ 2021-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k210946-promisemed-automatic-biopsy-needles-fda-510k.jpg K210946 - Promisemed Automatic Biopsy Needles, Promisemed Co-Axial Biopsy Devices, Promisemed Semi-automatic Biopsy Needles K210946 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Promisemed Hangzhou Meditech Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k211179/ 2021-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k211179-inferread-ct-strokeai-fda-510k.jpg K211179 - InferRead CT Stroke.AI K211179 is a FDA 510(k) cleared radiology medical device. Manufacturer: Infervision Medical Technology Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k211205/ 2021-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k211205-prase-c-anterior-cervical-plate-system-fda-510k.jpg K211205 - Prase-C Anterior Cervical Plate System K211205 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Gbs Commonwealth Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k211863/ 2021-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k211863-evolve-pacs-fda-510k.jpg K211863 - eVolve PACS K211863 is a FDA 510(k) cleared radiology medical device. Manufacturer: Evolve Pacs, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k212007/ 2021-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k212007-verticale-navigation-instruments-fda-510k.jpg K212007 - VERTICALE Navigation Instruments K212007 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Silony Medical GmbH. Cleared Aug 2021. https://www.510kdatabase.net/k202536/ 2021-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k202536-non-sterile-powder-free-nitrile-fda-510k.jpg K202536 - Non-sterile, Powder Free Nitrile Examination Aloe Vera Gloves, Low Dermatitis Potential, Tested for use with Chemotherapy Drugs, And Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs and Fentanyl Citrate K202536 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Yty Industry (Manjung) Sdn Bhd. Cleared Aug 2021. https://www.510kdatabase.net/k203152/ 2021-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k203152-disposable-face-mask-fda-510k.jpg K203152 - Disposable Face Mask K203152 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Chaozhou Cecilia Technology Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k203448/ 2021-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k203448-uct-atlas-with-uws-ct-dual-energy-fda-510k.jpg K203448 - uCT ATLAS with uWS-CT-Dual Energy Analysis K203448 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k203643/ 2021-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k203643-sensatronic-reusable-temperature-probes-fda-510k.jpg K203643 - Sensatronic Reusable Temperature Probes K203643 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sensatronic GmbH. Cleared Aug 2021. https://www.510kdatabase.net/k210687/ 2021-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k210687-contour-next-one-blood-glucose-fda-510k.jpg K210687 - CONTOUR® NEXT ONE Blood Glucose Monitoring System K210687 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Ascensia Diabetes Care. Cleared Aug 2021. https://www.510kdatabase.net/k210759/ 2021-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k210759-solo-swing-maxi-fda-510k.jpg K210759 - Solo, Swing Maxi K210759 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Medela, LLC. Cleared Aug 2021. https://www.510kdatabase.net/k211102/ 2021-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k211102-freestyle-libre-2-flash-glucose-fda-510k.jpg K211102 - FreeStyle Libre 2 Flash Glucose Monitoring System K211102 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Diabetes Care, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k211353/ 2021-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k211353-medical-face-mask-fda-510k.jpg K211353 - Medical Face Mask K211353 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen Lyttop Healthcare Limited. Cleared Aug 2021. https://www.510kdatabase.net/k211552/ 2021-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k211552-surgical-mask-fda-510k.jpg K211552 - Surgical mask K211552 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shandong Shengquan New Materials Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k211883/ 2021-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k211883-quantum-patient-specific-fda-510k.jpg K211883 - QUANTUM® Patient Specific Instrumentation (PSI) System K211883 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: In2bones Sas. Cleared Aug 2021. https://www.510kdatabase.net/k211993/ 2021-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k211993-z-linkpc-system-fda-510k.jpg K211993 - Z-LINKPC System K211993 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zavation Medical Products, LLC. Cleared Aug 2021. https://www.510kdatabase.net/k212204/ 2021-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k212204-synovasure-alpha-defensin-lateral-flow-fda-510k.jpg K212204 - Synovasure Alpha Defensin Lateral Flow Test Kit (1 Kit), Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit K212204 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Cd Diagnostics, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k201026/ 2021-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k201026-solve-tube-fda-510k.jpg K201026 - sOLVe Tube K201026 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Hytek Medical, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k210730/ 2021-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k210730-nitrile-patient-examination-glove-fda-510k.jpg K210730 - Nitrile Patient Examination Glove K210730 is a FDA 510(k) cleared general hospital medical device. Manufacturer: American Performance Polymers, LLC. Cleared Aug 2021. https://www.510kdatabase.net/k210820/ 2021-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k210820-eagle-edge-axr90-and-axr120-fda-510k.jpg K210820 - EAGLE EDGE AXR90 and AXR120 K210820 is a FDA 510(k) cleared radiology medical device. Manufacturer: Alliage S/A Industrias Medico Odontol?gica. Cleared Aug 2021. https://www.510kdatabase.net/k211414/ 2021-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k211414-kheiron-spinal-fixation-system-fda-510k.jpg K211414 - KHEIRON Spinal Fixation System K211414 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: S.M.A.I.O. Cleared Aug 2021. https://www.510kdatabase.net/k211640/ 2021-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k211640-ponto-5-mini-fda-510k.jpg K211640 - Ponto 5 Mini K211640 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Oticon Medical AB. Cleared Aug 2021. https://www.510kdatabase.net/k211799/ 2021-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k211799-biodentine-xp-500-biodentine-xp-200-fda-510k.jpg K211799 - Biodentine XP 500, Biodentine XP 200 K211799 is a FDA 510(k) cleared dental medical device. Manufacturer: Septodont. Cleared Aug 2021. https://www.510kdatabase.net/k211873/ 2021-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k211873-psx-interbody-system-fda-510k.jpg K211873 - PSX Interbody System K211873 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k211030/ 2021-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k211030-exalt-model-b-single-use-bronchoscope-fda-510k.jpg K211030 - EXALT Model B Single-Use Bronchoscope (Slim), EXALT Model B Single-Use Bronchoscope (Regular), EXALT Model B Single-Use Bronchoscope (Large), EXALT Monitor K211030 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Boston Scientific Corporation. Cleared Aug 2021. https://www.510kdatabase.net/k211299/ 2021-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k211299-x-cube-70-fda-510k.jpg K211299 - X-CUBE 70 K211299 is a FDA 510(k) cleared radiology medical device. Manufacturer: Alpinion Medical Systems Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k211300/ 2021-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k211300-x-cube-90-fda-510k.jpg K211300 - X-CUBE 90 K211300 is a FDA 510(k) cleared radiology medical device. Manufacturer: Alpinion Medical Systems Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k211540/ 2021-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k211540-edma-synthetic-nitrile-examination-fda-510k.jpg K211540 - Edma Synthetic Nitrile Examination Gloves K211540 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Edma Group, LLC. Cleared Aug 2021. https://www.510kdatabase.net/k211354/ 2021-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k211354-disposable-synthetic-vinyl-nitrile-fda-510k.jpg K211354 - Disposable Synthetic Vinyl Nitrile Examination Glove K211354 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Cureguard Glove Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k200193/ 2021-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k200193-kisses-plus-implant-system-fda-510k.jpg K200193 - Kisses Plus Implant System K200193 is a FDA 510(k) cleared dental medical device. Manufacturer: Achimhai Medical Corporation. Cleared Aug 2021. https://www.510kdatabase.net/k203136/ 2021-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k203136-diazyme-plac-test-for-lp-pla2-activity-fda-510k.jpg K203136 - Diazyme PLAC® Test for Lp-PLA2 Activity K203136 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diazyme Laboratories, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k203305/ 2021-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k203305-tiger-reusable-sharps-container-fda-510k.jpg K203305 - Tiger Reusable Sharps Container K203305 is a FDA 510(k) cleared general hospital medical device. Manufacturer: International Marketing Specialists, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k210320/ 2021-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k210320-clearcorrect-system-fda-510k.jpg K210320 - ClearCorrect System K210320 is a FDA 510(k) cleared dental medical device. Manufacturer: Clearcorrect, LLC. Cleared Aug 2021. https://www.510kdatabase.net/k210541/ 2021-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k210541-ulrichinject-ct-motion-fda-510k.jpg K210541 - ulrichINJECT CT motion K210541 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ulrich GmbH & Co. KG. Cleared Aug 2021. https://www.510kdatabase.net/k210725/ 2021-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k210725-nitrile-patient-examination-glove-fda-510k.jpg K210725 - Nitrile Patient Examination Glove K210725 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Pingan Medical Products Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k211202/ 2021-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k211202-1688-4k-camera-system-l11-led-light-fda-510k.jpg K211202 - 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes K211202 is a FDA 510(k) cleared neurology medical device. Manufacturer: Stryker. Cleared Aug 2021. https://www.510kdatabase.net/k211435/ 2021-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k211435-pao-cortical-screw-fda-510k.jpg K211435 - PAO Cortical Screw K211435 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Aug 2021. https://www.510kdatabase.net/k211725/ 2021-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k211725-senographe-pristina-fda-510k.jpg K211725 - Senographe Pristina K211725 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Aug 2021. https://www.510kdatabase.net/k211764/ 2021-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k211764-vereos-petct-fda-510k.jpg K211764 - Vereos PET/CT K211764 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Aug 2021. https://www.510kdatabase.net/k211783/ 2021-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k211783-trimed-threaded-intramedullary-nail-fda-510k.jpg K211783 - TriMed Threaded Intramedullary Nail System K211783 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: TriMed, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k211784/ 2021-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k211784-da-vinci-xi-surgical-system-is4000-da-fda-510k.jpg K211784 - da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) K211784 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k212100/ 2021-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k212100-kosmos-fda-510k.jpg K212100 - Kosmos K212100 is a FDA 510(k) cleared radiology medical device. Manufacturer: EchoNous, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k200904/ 2021-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k200904-tosoh-automated-glycohemoglobin-fda-510k.jpg K200904 - Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 K200904 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Tosoh Bioscience, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k201089/ 2021-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k201089-ark-lacosamide-assay-fda-510k.jpg K201089 - ARK Lacosamide Assay K201089 is a FDA 510(k) cleared toxicology medical device. Manufacturer: ARK Diagnostics, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k202621/ 2021-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k202621-neurosense-monitoring-system-model-ns-fda-510k.jpg K202621 - NeuroSENSE Monitoring System, Model NS-901 K202621 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Neurowave Systems, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k202969/ 2021-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k202969-biomet-microfixation-omnimax-mmf-system-fda-510k.jpg K202969 - Biomet Microfixation OmniMax MMF System K202969 is a FDA 510(k) cleared dental medical device. Manufacturer: Biomet Microfixation. Cleared Aug 2021. https://www.510kdatabase.net/k203006/ 2021-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k203006-r2-dermabrasion-tip-for-dermal-cooling-fda-510k.jpg K203006 - R2 Dermabrasion Tip (for Dermal Cooling System) K203006 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: R2 Technologies, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k203362/ 2021-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k203362-tracoe-vario-fda-510k.jpg K203362 - TRACOE vario K203362 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Tracoe Medical GmbH. Cleared Aug 2021. https://www.510kdatabase.net/k203727/ 2021-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k203727-harmony-latex-dam-harmony-non-latex-dam-fda-510k.jpg K203727 - Harmony Latex Dam, Harmony Non-Latex Dam K203727 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Pamco Distributing, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k210680/ 2021-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k210680-acqmap-high-resolution-imaging-and-fda-510k.jpg K210680 - AcQMap High Resolution Imaging and Mapping System K210680 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Acutus Medical, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k211075/ 2021-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k211075-disposable-medical-nitrile-examination-fda-510k.jpg K211075 - Disposable Medical Nitrile Examination Gloves (Non-Sterile) K211075 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Cherish Medical Technology Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k211388/ 2021-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k211388-lateral-spine-truss-system-lsts-fda-510k.jpg K211388 - Lateral Spine Truss System (LSTS) Interbody Fusion Device K211388 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 4Web Medical, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k211434/ 2021-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k211434-nitrile-patient-examination-gloves-fda-510k.jpg K211434 - Nitrile Patient Examination Gloves K211434 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zhangjiagang Huayuan Protective Equipment Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k211608/ 2021-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k211608-disposable-nitrile-medical-examination-fda-510k.jpg K211608 - Disposable Nitrile Medical Examination Glove (Tested for Use with Chemotherapy Drugs) K211608 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Cureguard Glove Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k211657/ 2021-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k211657-emphasys-femoral-stems-fda-510k.jpg K211657 - EMPHASYS Femoral Stems K211657 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Ireland UC. Cleared Aug 2021. https://www.510kdatabase.net/k211893/ 2021-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k211893-selectflex-neurovascular-access-system-fda-510k.jpg K211893 - SelectFlex Neurovascular Access System Family K211893 is a FDA 510(k) cleared neurology medical device. Manufacturer: Q'Apel Medical, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k203246/ 2021-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k203246-atlas-one-step-hcg-urine-pregnancy-fda-510k.jpg K203246 - Atlas One Step hCG Urine Pregnancy Test (Strip), Atlas One Step hCG Urine Pregnancy Test (Cassette), Atlas One Step hCG Urine Pregnancy Test (Midstream) K203246 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Atlas Link Technology Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k203464/ 2021-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k203464-dess-dental-smart-solutions-fda-510k.jpg K203464 - DESS Dental Smart Solutions K203464 is a FDA 510(k) cleared dental medical device. Manufacturer: Terrats Medical SL. Cleared Aug 2021. https://www.510kdatabase.net/k210643/ 2021-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k210643-disposable-surgical-face-mask-fda-510k.jpg K210643 - Disposable Surgical Face Mask K210643 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shandong Zhushi Pharmaceutical Group Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k210913/ 2021-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k210913-v12-pro-fda-510k.jpg K210913 - V12 PRO K210913 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Slk Medical GmbH. Cleared Aug 2021. https://www.510kdatabase.net/k211049/ 2021-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k211049-tigon-medical-button-system-fda-510k.jpg K211049 - Tigon Medical Button System K211049 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tigon Medical. Cleared Aug 2021. https://www.510kdatabase.net/k211068/ 2021-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k211068-previsea-device-fda-510k.jpg K211068 - PrevisEA Device K211068 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Entac Medical, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k211502/ 2021-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k211502-alpha-vent-peek-suture-anchor-fda-510k.jpg K211502 - Alpha Vent PEEK Suture Anchor K211502 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Endoscopy. Cleared Aug 2021. https://www.510kdatabase.net/k211553/ 2021-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k211553-tecomet-global-unite-short-stem-fda-510k.jpg K211553 - Tecomet Global Unite Short Stem Instrumentation K211553 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Symmetry Medical Manufacturing Inc. Dba Tecomet, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k211714/ 2021-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k211714-nitrile-exam-gloves-powder-freeblue-fda-510k.jpg K211714 - Nitrile Exam Gloves, Powder Free,Blue (Tested for Use with Chemotherapy) K211714 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hengchang (Dongying) Medical Technology Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k211838/ 2021-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k211838-ultrasonic-bipolar-generator-usg-410-fda-510k.jpg K211838 - Ultrasonic Bipolar Generator USG-410 with accessories K211838 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Olympus Medical Systems Corporation. Cleared Aug 2021. https://www.510kdatabase.net/k212056/ 2021-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k212056-vantage-galan-3t-mrt-3020-v70-with-fda-510k.jpg K212056 - Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR K212056 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Aug 2021. https://www.510kdatabase.net/k201246/ 2021-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k201246-pta-balloon-catheter-pvq-mit-pta-fda-510k.jpg K201246 - PTA Balloon Catheter (PVQ), MIT PTA Balloon Catheter (PVQ) K201246 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Qualimed USA, LLC. Cleared Aug 2021. https://www.510kdatabase.net/k210651/ 2021-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k210651-resection-electrodes-with-hf-cable-fda-510k.jpg K210651 - Resection Electrodes with HF cable K210651 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Olympus Winter & Ibe GmbH. Cleared Aug 2021. https://www.510kdatabase.net/k210724/ 2021-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k210724-encore-latex-acclaim-powder-free-latex-fda-510k.jpg K210724 - ENCORE Latex Acclaim, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Standard, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (50 ug/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs K210724 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Careplus (M) Sdn Bhd. Cleared Aug 2021. https://www.510kdatabase.net/k211026/ 2021-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k211026-minitube-dentasleeve-protective-fda-510k.jpg K211026 - Minitube Dentasleeve Protective Barrier Sleeves K211026 is a FDA 510(k) cleared dental medical device. Manufacturer: Minitube AB. Cleared Aug 2021. https://www.510kdatabase.net/k211290/ 2021-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k211290-cannulated-fasteners-and-nuts-fda-510k.jpg K211290 - Cannulated Fasteners and Nuts K211290 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OsteoCentric Technologies. Cleared Aug 2021. https://www.510kdatabase.net/k211758/ 2021-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k211758-polychloroprene-powder-free-fda-510k.jpg K211758 - Polychloroprene Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Fusion Colour) K211758 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hartalega NGC Sdn. Bhd.. Cleared Aug 2021. https://www.510kdatabase.net/k211806/ 2021-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k211806-venclose-digirf-generator-with-maven-fda-510k.jpg K211806 - Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter K211806 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Venclose, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k211897/ 2021-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k211897-surgical-face-mask-fda-510k.jpg K211897 - Surgical Face Mask K211897 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zhejiang Hongyu Medicali Commodity Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k212144/ 2021-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k212144-remex-ka6-fda-510k.jpg K212144 - Remex KA6 K212144 is a FDA 510(k) cleared radiology medical device. Manufacturer: Remedi Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k200986/ 2021-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k200986-opti-b-lac-cassette-fda-510k.jpg K200986 - OPTI® B-Lac Cassette K200986 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Opti Medical Systems, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k203174/ 2021-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k203174-disposable-medical-mask-fda-510k.jpg K203174 - Disposable Medical Mask K203174 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Dong Guan Kinyet Metal Products Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k203538/ 2021-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k203538-sensicare-pi-ortho-lt-surgical-glove-fda-510k.jpg K203538 - SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs) K203538 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k203542/ 2021-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k203542-neodent-implant-system-mini-abutment-60-fda-510k.jpg K203542 - Neodent Implant System - Mini Abutment 60° K203542 is a FDA 510(k) cleared dental medical device. Manufacturer: Jjgc Industria E Comercio DE Materiais Dentarios S.A.. Cleared Aug 2021. https://www.510kdatabase.net/k210339/ 2021-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k210339-bullfrog-micro-infusion-device-fda-510k.jpg K210339 - Bullfrog Micro-Infusion Device K210339 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Mercator Medsystems, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k210521/ 2021-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k210521-dexa-c-cervical-interbody-system-fda-510k.jpg K210521 - DEXA-C Cervical Interbody System K210521 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aurora Spine, Inc.. Cleared Aug 2021. https://www.510kdatabase.net/k211431/ 2021-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k211431-breastscape-v10-fda-510k.jpg K211431 - breastscape v1.0 K211431 is a FDA 510(k) cleared radiology medical device. Manufacturer: Olea Medical. Cleared Aug 2021. https://www.510kdatabase.net/k212106/ 2021-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k212106-relivion-fda-510k.jpg K212106 - Relivion K212106 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neurolief , Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k212175/ 2021-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k212175-dynacad-fda-510k.jpg K212175 - DynaCAD K212175 is a FDA 510(k) cleared radiology medical device. Manufacturer: Invivo Corporation. Cleared Aug 2021. https://www.510kdatabase.net/k211182/ 2021-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k211182-h2h-powder-free-examination-blue-glove-fda-510k.jpg K211182 - H2H Powder Free Examination Blue Glove K211182 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ntl Innovation Co., Ltd.. Cleared Aug 2021. https://www.510kdatabase.net/k200770/ 2021-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k200770-mini-pcnl-system-fda-510k.jpg K200770 - Mini PCNL-System K200770 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Trokamed GmbH. Cleared Jul 2021. https://www.510kdatabase.net/k201761/ 2021-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k201761-freestyle-libre-2-flash-glucose-fda-510k.jpg K201761 - FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App) K201761 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Diabetes Care, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k202208/ 2021-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k202208-benehold-surgical-incise-drape-with-fda-510k.jpg K202208 - BeneHold Surgical Incise Drape with CHG antimicrobial K202208 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Avery Dennison Belgie Bvba. Cleared Jul 2021. https://www.510kdatabase.net/k202780/ 2021-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k202780-sectum-fda-510k.jpg K202780 - Sectum K202780 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Neauvia North America. Cleared Jul 2021. https://www.510kdatabase.net/k203224/ 2021-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k203224-acumen-hypotension-prediction-index-fda-510k.jpg K203224 - Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform K203224 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Jul 2021. https://www.510kdatabase.net/k203408/ 2021-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k203408-summit-patella-plating-system-fda-510k.jpg K203408 - Summit Patella Plating System K203408 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Endeavor Orthopaedics, LLC. Cleared Jul 2021. https://www.510kdatabase.net/k203700/ 2021-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k203700-thermo-scientific-oxoid-cefiderocol-fda-510k.jpg K203700 - Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30 K203700 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Oxoid Limited (Part of Thermo Fisher Scientific). Cleared Jul 2021. https://www.510kdatabase.net/k203796/ 2021-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k203796-firefly-needleless-connector-fda-510k.jpg K203796 - Firefly Needleless Connector K203796 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Puracath Medical, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k210154/ 2021-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k210154-labat-series-diagnostic-ultrasound-fda-510k.jpg K210154 - Labat series Diagnostic Ultrasound System K210154 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Wisonic Medical Technology Co. , Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k210248/ 2021-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k210248-lab-bag-with-fabric-pouch-fda-510k.jpg K210248 - Lab Bag with Fabric Pouch K210248 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Advanced Medical Design Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k210264/ 2021-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k210264-bd-powerpicc-catheter-fda-510k.jpg K210264 - BD PowerPiCC Catheter K210264 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bard Access Systems, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k210274/ 2021-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k210274-fingertip-pulse-oximeter-fda-510k.jpg K210274 - Fingertip Pulse Oximeter K210274 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Zhuhai Linte Medical Instrument Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k210691/ 2021-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k210691-disposable-nitrile-medical-examination-fda-510k.jpg K210691 - Disposable Nitrile Medical Examination Glove K210691 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Cureguard Glove Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k210768/ 2021-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k210768-wrist-blood-pressure-monitor-blood-fda-510k.jpg K210768 - Wrist Blood Pressure Monitor, Blood Pressure Monitor K210768 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Andon Health Co, Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k210870/ 2021-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k210870-meo-med-disposable-medical-face-mask-fda-510k.jpg K210870 - MEO Med Disposable Medical Face Mask K210870 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Fujian Meo Medical Technology Limited. Cleared Jul 2021. https://www.510kdatabase.net/k210938/ 2021-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k210938-powerdot-pd-01mt2-muscle-stimulator-fda-510k.jpg K210938 - PowerDot PD-01MT2 Muscle Stimulator K210938 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Smartmissimo Technologies Pte, Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k211222/ 2021-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k211222-qer-quant-fda-510k.jpg K211222 - qER-Quant K211222 is a FDA 510(k) cleared radiology medical device. Manufacturer: Qure.Ai Technologies. Cleared Jul 2021. https://www.510kdatabase.net/k211264/ 2021-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k211264-disposable-nitrile-examination-gloves-fda-510k.jpg K211264 - Disposable Nitrile Examination Gloves K211264 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen Shiqiao Science and Technology Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k211338/ 2021-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k211338-embotrap-iii-revascularization-device-fda-510k.jpg K211338 - EMBOTRAP III Revascularization Device K211338 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neuravi, Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k211379/ 2021-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k211379-syngovia-rt-image-suite-fda-510k.jpg K211379 - syngo.via RT Image Suite K211379 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k211380/ 2021-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k211380-elexir-fda-510k.jpg K211380 - Elexir K211380 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nu Eyne Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k211402/ 2021-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k211402-powersculp-laser-lipolysis-system-fda-510k.jpg K211402 - Powersculp laser lipolysis system K211402 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lotuxs Medtech (Suzhou) Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k211492/ 2021-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k211492-pounce-thrombectomy-system-fda-510k.jpg K211492 - Pounce Thrombectomy System K211492 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Surmodics,Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k211710/ 2021-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k211710-ascent-poct-system-centurion-poct-fda-510k.jpg K211710 - Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal Fixation Systems: (Firebird Deformity Spinal Fixation System, Phoenix MIS Spinal Fixation System, Phoenix CDX MIS Spinal Fixation System, JANUS Midline Fixation Screws, Firebird NXG Spinal Fixation System, JANUS Fenestrated Screws), Connector System, FIREBIRD SI Fusion System K211710 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthofix, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k211761/ 2021-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k211761-ultralase-flexible-co2-laser-waveguide-fda-510k.jpg K211761 - UltraLase Flexible CO2 Laser Waveguide K211761 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W & R Investments, LLC Dba Laser Engineering. Cleared Jul 2021. https://www.510kdatabase.net/k211790/ 2021-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k211790-dx-d-imaging-package-with-xd-detectors-fda-510k.jpg K211790 - DX-D Imaging Package with XD Detectors K211790 is a FDA 510(k) cleared radiology medical device. Manufacturer: Agfa N.V.. Cleared Jul 2021. https://www.510kdatabase.net/k212035/ 2021-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k212035-fibroscan-230-fda-510k.jpg K212035 - FibroScan 230 K212035 is a FDA 510(k) cleared radiology medical device. Manufacturer: Echosens. Cleared Jul 2021. https://www.510kdatabase.net/k202825/ 2021-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k202825-bti-extra-short-dental-implant-system-fda-510k.jpg K202825 - BTI Extra-Short Dental Implant System UnicCa K202825 is a FDA 510(k) cleared dental medical device. Manufacturer: B.T.I. Biotechnology Institute, Sl.. Cleared Jul 2021. https://www.510kdatabase.net/k203753/ 2021-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k203753-straumann-surgical-cassettes-fda-510k.jpg K203753 - Straumann Surgical Cassettes K203753 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Straumann USA, LLC. Cleared Jul 2021. https://www.510kdatabase.net/k210115/ 2021-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k210115-fitebac-cc-orthoseal-fda-510k.jpg K210115 - FiteBac CC OrthoSeal K210115 is a FDA 510(k) cleared dental medical device. Manufacturer: Largent Health, LLC. Cleared Jul 2021. https://www.510kdatabase.net/k210574/ 2021-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k210574-nuvasive-pulse-system-fda-510k.jpg K210574 - NuVasive Pulse System K210574 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Jul 2021. https://www.510kdatabase.net/k210770/ 2021-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k210770-arm-blood-pressure-monitor-wireless-fda-510k.jpg K210770 - Arm Blood Pressure Monitor, Wireless Blood Pressure Monitor K210770 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Andon Health Co, Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k210862/ 2021-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k210862-hemafuse-system-fda-510k.jpg K210862 - Hemafuse System K210862 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sisu Global Health. Cleared Jul 2021. https://www.510kdatabase.net/k210953/ 2021-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k210953-smart-taylor-spatial-frame-fda-510k.jpg K210953 - SMART Taylor Spatial Frame K210953 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k211131/ 2021-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k211131-disposable-nitrile-medical-examination-fda-510k.jpg K211131 - Disposable Nitrile Medical Examination Glove K211131 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Siyang Threeguard Medical Supplies Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k211229/ 2021-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k211229-vinyl-compound-examination-gloves-fda-510k.jpg K211229 - Vinyl compound examination gloves K211229 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hebei Titans Hongsen Medical Technology Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k211314/ 2021-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k211314-ocs-lung-solution-fda-510k.jpg K211314 - OCS Lung Solution K211314 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: TransMedics, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k211317/ 2021-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k211317-cruxview-fda-510k.jpg K211317 - CRUXVIEW K211317 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cruxell Corp.. Cleared Jul 2021. https://www.510kdatabase.net/k211341/ 2021-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k211341-blue-nitrile-exam-gloves-fda-510k.jpg K211341 - Blue Nitrile Exam Gloves K211341 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangxi Surefine Medical Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k211663/ 2021-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k211663-zap-x-radiosurgical-system-fda-510k.jpg K211663 - Zap-X Radiosurgical System K211663 is a FDA 510(k) cleared radiology medical device. Manufacturer: Zap Surgical Systems, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k211664/ 2021-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k211664-gmk-sphere-revision-fda-510k.jpg K211664 - GMK Sphere Revision K211664 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Jul 2021. https://www.510kdatabase.net/k201657/ 2021-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k201657-corin-ltd-hip-products-trinity-fda-510k.jpg K201657 - Corin Ltd. Hip Products: Trinity™ Acetabular System, Trinity™ PLUS Acetabular Shell, MetaFix™ Hip System, TriFit™ CF and TS Hip Systems, TaperFit™ Hip System, Revival™ Modular Hip System, MiniHip™, Trinity™ Dual Mobility, MobiliT, BiPolar-i, OMNI MOD™ Hip System, OMNI K1 and K2 Hip Systems, OMNI Bipolar Heads, Corin Biolox Delta Ceramic Heads, OMNI Delta Ceramic Heads K201657 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corin, Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k203359/ 2021-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k203359-bd-flu-syringe-fda-510k.jpg K203359 - BD Flu+ Syringe K203359 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson and Company. Cleared Jul 2021. https://www.510kdatabase.net/k203431/ 2021-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k203431-disposable-ear-thermometer-probe-cover-fda-510k.jpg K203431 - Disposable Ear Thermometer Probe Cover K203431 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Huaian Zhongxin Packing Material Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k210189/ 2021-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k210189-pac-dent-denture-base-resin-fda-510k.jpg K210189 - Pac-Dent Denture Base Resin K210189 is a FDA 510(k) cleared dental medical device. Manufacturer: Pac-Dent, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k210379/ 2021-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k210379-broncho-videoscope-system-fda-510k.jpg K210379 - Broncho Videoscope System K210379 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Scivita Medical Technology Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k210409/ 2021-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k210409-disposable-surgical-face-mask-fda-510k.jpg K210409 - Disposable Surgical Face Mask K210409 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shandong Zhushi Pharmaceutical Group Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k210856/ 2021-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k210856-purism-disposable-surgical-mask-fda-510k.jpg K210856 - Purism Disposable Surgical Mask K210856 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Chuzhou Daddy'S Choice Science and Technology Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k211014/ 2021-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k211014-portray-fda-510k.jpg K211014 - Portray K211014 is a FDA 510(k) cleared radiology medical device. Manufacturer: Surround Medical Systems. Cleared Jul 2021. https://www.510kdatabase.net/k211129/ 2021-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k211129-neocis-guidance-system-ngs-with-fda-510k.jpg K211129 - Neocis Guidance System (NGS) with Intraoral Fiducial Array K211129 is a FDA 510(k) cleared dental medical device. Manufacturer: Neocis, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k211225/ 2021-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k211225-mis-ti-base-abutment-fda-510k.jpg K211225 - MIS Ti-base abutment K211225 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona. Cleared Jul 2021. https://www.510kdatabase.net/k211335/ 2021-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k211335-diode-laser-machine-model-number-bm-100-fda-510k.jpg K211335 - Diode Laser Machine, Model Number: BM-100 K211335 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Zhengzhou Bestview ST Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k211395/ 2021-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k211395-nio-i-fda-510k.jpg K211395 - NIO-I K211395 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Einstein Works, LLC. Cleared Jul 2021. https://www.510kdatabase.net/k211455/ 2021-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k211455-powder-free-nitrile-examination-gloves-fda-510k.jpg K211455 - Powder Free Nitrile Examination Gloves with Aloe Vera, Orange and Orange-White Colors K211455 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shen Wei (Usa), Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k211489/ 2021-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k211489-dental-impression-material-fda-510k.jpg K211489 - Dental Impression Material K211489 is a FDA 510(k) cleared dental medical device. Manufacturer: Nanchang Dental Bright Technology Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k211497/ 2021-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k211497-surgical-mask-fda-510k.jpg K211497 - Surgical Mask K211497 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Honeywell Safety Products. Cleared Jul 2021. https://www.510kdatabase.net/k211646/ 2021-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k211646-fine-osteotomy-fda-510k.jpg K211646 - FINE Osteotomy K211646 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Bodycad Laboratories, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k211677/ 2021-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k211677-eleos-limb-salvage-system-fda-510k.jpg K211677 - ELEOS Limb Salvage System K211677 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Onkos Surgical. Cleared Jul 2021. https://www.510kdatabase.net/k211839/ 2021-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k211839-electrode-market-disposable-surface-fda-510k.jpg K211839 - Electrode Market Disposable Surface Electrodes K211839 is a FDA 510(k) cleared neurology medical device. Manufacturer: Electrode Market Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k211861/ 2021-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k211861-taiji-professional-series-level-3-fda-510k.jpg K211861 - TAIJI Professional Series Level 3 Surgical Face Mask K211861 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Taiji Medical Supplies, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k211874/ 2021-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k211874-gnther-tulip-vena-cava-filter-set-for-fda-510k.jpg K211874 - Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Jugular Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach K211874 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: William Cook Europe Aps. Cleared Jul 2021. https://www.510kdatabase.net/k211875/ 2021-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k211875-cook-celect-platinum-vena-cava-filter-fda-510k.jpg K211875 - Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filte Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach K211875 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: William Cook Europe Aps. Cleared Jul 2021. https://www.510kdatabase.net/k211991/ 2021-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k211991-catalyst-r1-reverse-shoulder-system-fda-510k.jpg K211991 - Catalyst R1 Reverse Shoulder System K211991 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Catalyst Orthoscience, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k211994/ 2021-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k211994-braun-silkexpert-mini-fda-510k.jpg K211994 - Braun Silk.expert Mini K211994 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cyden Limited. Cleared Jul 2021. https://www.510kdatabase.net/k201326/ 2021-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k201326-psychemedics-homogeneous-enzyme-fda-510k.jpg K201326 - Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Opiates in Hair, Psychemedics Homogeneous Enzyme Immunoassay (HEIA) for Oxycodone in Hair K201326 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Psychemedics Corporation. Cleared Jul 2021. https://www.510kdatabase.net/k210016/ 2021-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k210016-integra-digifuse-cannulated-fda-510k.jpg K210016 - Integra DigiFuse Cannulated Intramedullary Fusion System,Integra Total Foot System,Integra CAPTURE Screw System & Integra Ti6 Internal Fixation System,Subtalar MBA System,MetaSurg Subtalar Implant,NewDeal BOLD Screw,NewDeal HALLU Lock Plate System,NewDeal HALLU Plates,QWIX Positioning Screw,SPIN Snap-Off Screw,NewDeal TIBIAXYS System K210016 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Integra LifeSciences Corporation. Cleared Jul 2021. https://www.510kdatabase.net/k210469/ 2021-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k210469-insight-agile-drf-fda-510k.jpg K210469 - Insight Agile DRF K210469 is a FDA 510(k) cleared radiology medical device. Manufacturer: Imaging Engineering, LLC. Cleared Jul 2021. https://www.510kdatabase.net/k210635/ 2021-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k210635-route-92-medical-full-length-088-fda-510k.jpg K210635 - Route 92 Medical Full Length 088 Access System K210635 is a FDA 510(k) cleared neurology medical device. Manufacturer: Route 92 Medical, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k210664/ 2021-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k210664-dabra-laser-system-dabra-laser-model-fda-510k.jpg K210664 - DABRA Laser System (DABRA Laser model RA-308 and DABRA Catheter model 101) K210664 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ra Medical Systems,Inc. Cleared Jul 2021. https://www.510kdatabase.net/k210736/ 2021-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k210736-doctorgram-stethoscope-des-i-fda-510k.jpg K210736 - doctorgram Stethoscope DES-I K210736 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Gv Concepts. Cleared Jul 2021. https://www.510kdatabase.net/k210791/ 2021-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k210791-us2v1-fda-510k.jpg K210791 - Us2.v1 K210791 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eko.Ai Pte Ltd. D/B/A Us2.Ai. Cleared Jul 2021. https://www.510kdatabase.net/k210884/ 2021-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k210884-1derful-hs-1derful-ht-fda-510k.jpg K210884 - 1Derful HS, 1Derful HT K210884 is a FDA 510(k) cleared dental medical device. Manufacturer: 1derful, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k211247/ 2021-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k211247-pet-vcar-fda-510k.jpg K211247 - PET VCAR K211247 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems SCS. Cleared Jul 2021. https://www.510kdatabase.net/k211279/ 2021-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k211279-volpara-imaging-software-fda-510k.jpg K211279 - Volpara Imaging Software K211279 is a FDA 510(k) cleared radiology medical device. Manufacturer: Volpara Health Technologies Limited. Cleared Jul 2021. https://www.510kdatabase.net/k211325/ 2021-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k211325-senhance-surgical-system-fda-510k.jpg K211325 - Senhance Surgical System K211325 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Asensus Surgical, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k211655/ 2021-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k211655-apromise-fda-510k.jpg K211655 - aPROMISE K211655 is a FDA 510(k) cleared radiology medical device. Manufacturer: Exini Diagnostics AB. Cleared Jul 2021. https://www.510kdatabase.net/k211932/ 2021-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k211932-fixxsure-anterior-lumbar-plate-and-fda-510k.jpg K211932 - Fixxsure Anterior Lumbar Plate and Screw System K211932 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Oak Tree Engineering, LLC. Cleared Jul 2021. https://www.510kdatabase.net/k211989/ 2021-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k211989-aveir-introducer-fda-510k.jpg K211989 - Aveir Introducer K211989 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared Jul 2021. https://www.510kdatabase.net/k211990/ 2021-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k211990-rist-071-radial-access-guide-catheter-fda-510k.jpg K211990 - Rist 071 Radial Access Guide Catheter K211990 is a FDA 510(k) cleared neurology medical device. Manufacturer: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. Cleared Jul 2021. https://www.510kdatabase.net/k212074/ 2021-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k212074-clarictai-fda-510k.jpg K212074 - ClariCT.AI K212074 is a FDA 510(k) cleared radiology medical device. Manufacturer: Claripi, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k200129/ 2021-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k200129-oncomate-msi-dx-analysis-system-fda-510k.jpg K200129 - OncoMate MSI Dx Analysis System K200129 is a FDA 510(k) cleared pathology medical device. Manufacturer: Promega Corporation. Cleared Jul 2021. https://www.510kdatabase.net/k210412/ 2021-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k210412-pac-dent-ceramic-nanohybrid-resin-fda-510k.jpg K210412 - Pac-Dent Ceramic Nanohybrid Resin K210412 is a FDA 510(k) cleared dental medical device. Manufacturer: Pac-Dent, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k210477/ 2021-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k210477-atricure-isolator-encompass-ablation-fda-510k.jpg K210477 - AtriCure Isolator Encompass Ablation System, GLIDEPATH Magnetic GUIDE K210477 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: AtriCure, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k211643/ 2021-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k211643-vision-monitor-monpackone-fda-510k.jpg K211643 - Vision Monitor - MonpackONE K211643 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Metrovision. Cleared Jul 2021. https://www.510kdatabase.net/k211984/ 2021-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k211984-masc-surgical-mask-fda-510k.jpg K211984 - MASC Surgical Mask K211984 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Mid-America Safety Corp.. Cleared Jul 2021. https://www.510kdatabase.net/k211262/ 2021-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k211262-disposable-vinyl-nitrile-synthetic-fda-510k.jpg K211262 - Disposable Vinyl Nitrile Synthetic Gloves Powder Free K211262 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Tangshan Hongyun Healthcare Products Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k211363/ 2021-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k211363-medical-face-mask-fda-510k.jpg K211363 - Medical Face Mask K211363 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hubei Kangning Protective Products Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k201160/ 2021-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k201160-hanarostent-esophagus-ccc-hanarostent-fda-510k.jpg K201160 - HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN) K201160 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: M.I. Tech Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k201265/ 2021-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k201265-disposable-microwave-therapeutic-fda-510k.jpg K201265 - Disposable Microwave Therapeutic Antennas K201265 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Nanjing Eco Microwave System Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k201887/ 2021-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k201887-vs-newborn-heart-rate-monitor-fda-510k.jpg K201887 - VS Newborn Heart Rate Monitor K201887 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Surepulse Medical Limited. Cleared Jul 2021. https://www.510kdatabase.net/k202060/ 2021-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k202060-disposable-iv-catheter-fda-510k.jpg K202060 - Disposable IV catheter K202060 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shinva Ande Healthcare Apparatus Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k202296/ 2021-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k202296-infrared-forehead-thermometer-model-fda-510k.jpg K202296 - Infrared Forehead Thermometer, Model BSX976 K202296 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen Bsx Technology Electronics Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k202612/ 2021-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k202612-sensititre-20-24-hour-haemophilus-fda-510k.jpg K202612 - Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dtest (containing erythromycin at 1 ug/mL and clindamycin at 0.5 ug/mL) K202612 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Thermo Fisher Scientific. Cleared Jul 2021. https://www.510kdatabase.net/k202727/ 2021-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k202727-peregrine-endoscopy-system-fda-510k.jpg K202727 - Peregrine Endoscopy System K202727 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: 3nt Medical , Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k210159/ 2021-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k210159-intralock-system-fda-510k.jpg K210159 - IntraLock System K210159 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Fusion Orthopedics, LLC. Cleared Jul 2021. https://www.510kdatabase.net/k210185/ 2021-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k210185-cardiocurve-steerable-sheath-fda-510k.jpg K210185 - CardioCurve Steerable Sheath K210185 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Talon Surgical. Cleared Jul 2021. https://www.510kdatabase.net/k210311/ 2021-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k210311-home-use-ipl-beauty-device-models-ms-fda-510k.jpg K210311 - Home Use IPL Beauty Device, Model(s): MS-208B, MS-212B, MS-216B, MS-218B, MELSYA-M6, MELSYA-M7. K210311 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Mismon Technology Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k210382/ 2021-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k210382-blustone-synergy-diamond-sa-cervical-fda-510k.jpg K210382 - Blustone Synergy Diamond SA Cervical System K210382 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Blustone Synergy, LLC. Cleared Jul 2021. https://www.510kdatabase.net/k210468/ 2021-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k210468-sc1-handheld-ultrasound-imaging-system-fda-510k.jpg K210468 - SC1 Handheld Ultrasound Imaging System (Model: SC1) K210468 is a FDA 510(k) cleared radiology medical device. Manufacturer: Fcu Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k210903/ 2021-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k210903-is-multi-unit-abutment-system-fda-510k.jpg K210903 - IS Multi Unit Abutment System K210903 is a FDA 510(k) cleared dental medical device. Manufacturer: Neobiotech Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k211012/ 2021-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k211012-nitrile-patient-examination-gloves-fda-510k.jpg K211012 - Nitrile Patient Examination Gloves K211012 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Huayuan Medical Technology(Shangqiu) Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k211249/ 2021-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k211249-altor-safety-3-ply-surgical-mask-fda-510k.jpg K211249 - Altor Safety 3-Ply Surgical Mask (Model:62222) K211249 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Altor Safety, LLC. Cleared Jul 2021. https://www.510kdatabase.net/k211316/ 2021-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k211316-da-vinci-sp-surgical-system-sp1098-fda-510k.jpg K211316 - da Vinci SP Surgical System (SP1098) K211316 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k211386/ 2021-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k211386-myspine-webplanner-mybalance-fda-510k.jpg K211386 - MySpine WebPlanner & MyBalance K211386 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medacta International S.A.. Cleared Jul 2021. https://www.510kdatabase.net/k211602/ 2021-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k211602-klassic-knee-system-fda-510k.jpg K211602 - Klassic Knee System K211602 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Total Joint Orthopedics, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k211951/ 2021-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k211951-gi-genius-fda-510k.jpg K211951 - GI Genius K211951 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cosmo Artificial Intelligence - Ai, Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k212030/ 2021-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k212030-flex-thread-distal-fibula-fda-510k.jpg K212030 - Flex-Thread™ Distal Fibula lntramedullary Nail System K212030 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Flower Orthopedics Corporation Dba Conventus Flower. Cleared Jul 2021. https://www.510kdatabase.net/k212052/ 2021-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k212052-hmb32-dialysis-solution-fda-510k.jpg K212052 - HMB32 Dialysis Solution K212052 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Haemopharm Biofluids S.R.L.. Cleared Jul 2021. https://www.510kdatabase.net/k202582/ 2021-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k202582-arthrex-synergyid-endoscopic-imaging-fda-510k.jpg K202582 - Arthrex SynergyID Endoscopic Imaging System K202582 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Arthrex, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k202603/ 2021-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k202603-temp-pal-fda-510k.jpg K202603 - Temp Pal K202603 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Iweecare Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k203175/ 2021-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k203175-polarstem-cemented-femoral-stem-fda-510k.jpg K203175 - POLARSTEM Cemented Femoral Stem K203175 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k203214/ 2021-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k203214-demarkq-wow-demarkq-pop-fda-510k.jpg K203214 - DemarkQ WOW, DemarkQ POP K203214 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Kaiyan Medical CO , Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k203411/ 2021-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k203411-syngoct-skull-unfolding-fda-510k.jpg K203411 - syngo.CT Skull Unfolding K203411 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k203694/ 2021-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k203694-delta-xtend-reverse-shoulder-system-fda-510k.jpg K203694 - DELTA XTEND Reverse Shoulder System K203694 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Ireland UC. Cleared Jul 2021. https://www.510kdatabase.net/k210143/ 2021-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k210143-standard-surgical-gown-aami-level-3-fda-510k.jpg K210143 - Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3) K210143 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Foshan Nanhai Plus Medical Co, Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k210176/ 2021-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k210176-flowsaver-blood-filter-fda-510k.jpg K210176 - FlowSaver Blood Filter K210176 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inari Medical. Cleared Jul 2021. https://www.510kdatabase.net/k210391/ 2021-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k210391-single-use-medical-face-mask-fda-510k.jpg K210391 - Single-use medical face mask K210391 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zhuhai Herald Datanetics Limited.. Cleared Jul 2021. https://www.510kdatabase.net/k210415/ 2021-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k210415-qsm-software-qsmetric-fda-510k.jpg K210415 - QSM software, QSMetric K210415 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medimagemetric, LLC. Cleared Jul 2021. https://www.510kdatabase.net/k210579/ 2021-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k210579-wiscope-om-endoscope-system-wiscope-fda-510k.jpg K210579 - WiScope OM Endoscope System, WiScope Single-Use Digital Flexible Ureteroscope.Choledochoscope, WiScope Image System K210579 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: OTU Medical, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k211220/ 2021-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k211220-nitrile-patient-examination-gloves-fda-510k.jpg K211220 - Nitrile Patient Examination Gloves Blue Tested For Use With Chemotherapy Drugs, Nitrile Patient Examination Gloves Blue Violet Tested For Use With Chemotherapy Drugs K211220 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guangdong Kingfa Sci. & Tech.Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k211633/ 2021-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k211633-vantage-orian-15t-mrt-1550-v70-with-fda-510k.jpg K211633 - Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR K211633 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Jul 2021. https://www.510kdatabase.net/k211688/ 2021-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k211688-dc-air-and-athlos-1-and-athlos-air-fda-510k.jpg K211688 - DC-Air and Athlos-1 and Athlos-Air K211688 is a FDA 510(k) cleared radiology medical device. Manufacturer: Athlos OY. Cleared Jul 2021. https://www.510kdatabase.net/k211939/ 2021-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k211939-exactrac-dynamic-fda-510k.jpg K211939 - ExacTrac Dynamic K211939 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab AG. Cleared Jul 2021. https://www.510kdatabase.net/k211944/ 2021-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k211944-medline-unite-digital-fusion-screw-fda-510k.jpg K211944 - Medline UNITE® Digital Fusion Screw System K211944 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medline Industries, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k211968/ 2021-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k211968-nio-adult-fda-510k.jpg K211968 - NIO+ Adult K211968 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Waismed, Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k212008/ 2021-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k212008-reveal-linq-insertable-cardiac-monitor-fda-510k.jpg K212008 - Reveal LINQ Insertable Cardiac Monitor K212008 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k193352/ 2021-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k193352-abutmentcad-fda-510k.jpg K193352 - AbutmentCAD K193352 is a FDA 510(k) cleared dental medical device. Manufacturer: Exocad GmbH. Cleared Jul 2021. https://www.510kdatabase.net/k201009/ 2021-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k201009-chiravac-blood-collection-needles-fda-510k.jpg K201009 - CHIRAVAC Blood Collection Needles K201009 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Chirana T. Injecta. Cleared Jul 2021. https://www.510kdatabase.net/k202868/ 2021-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k202868-lifesignals-multi-parameter-remote-fda-510k.jpg K202868 - LifeSignals Multi-Parameter Remote Monitoring Platform K202868 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Lifesignals, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k203271/ 2021-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k203271-aduro-light-therapy-handheld-fda-510k.jpg K203271 - Aduro light therapy Handheld K203271 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Kaiyan Medical CO , Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k203534/ 2021-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k203534-surgical-face-mask-model-flat-ear-fda-510k.jpg K203534 - Surgical face mask (Model: Flat Ear Loop/CN102) K203534 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Crown Name Disposable Hygiene Products Fty., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k210059/ 2021-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k210059-promisemed-insulin-pen-needle-fda-510k.jpg K210059 - Promisemed Insulin Pen Needle K210059 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Promisemed Hangzhou Meditech Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k210686/ 2021-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k210686-nitrile-patient-examination-glove-fda-510k.jpg K210686 - Nitrile Patient Examination Glove K210686 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Yunnan Huazhiyuan Medical Technology Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k210688/ 2021-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k210688-aero-chrome-select-breathable-fda-510k.jpg K210688 - AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown K210688 is a FDA 510(k) cleared general hospital medical device. Manufacturer: O&M Halyard, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k210970/ 2021-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k210970-single-use-surgical-mask-model-fe2311b-fda-510k.jpg K210970 - Single-Use Surgical Mask Model FE2311B K210970 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Byd Precison Manufacturer Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k211223/ 2021-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k211223-advantage-ultra-system-advantage-fit-fda-510k.jpg K211223 - Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System K211223 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Jul 2021. https://www.510kdatabase.net/k211901/ 2021-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k211901-moleculightdx-fda-510k.jpg K211901 - MolecuLightDX K211901 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Moleculight, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k211958/ 2021-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k211958-cd-horizon-spinal-system-fda-510k.jpg K211958 - CD Horizon Spinal System K211958 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k203168/ 2021-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k203168-lifelens-wireless-ecg-monitor-fda-510k.jpg K203168 - LifeLens Wireless ECG Monitor K203168 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: LifeLens Technologies, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k203712/ 2021-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k203712-the-slide-fda-510k.jpg K203712 - The Slide K203712 is a FDA 510(k) cleared dental medical device. Manufacturer: Biotex, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k203765/ 2021-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k203765-zirkonzahnimplant-planner-fda-510k.jpg K203765 - ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice, CAD/CAM STL Converter, CAD/CAM Z-Tray K203765 is a FDA 510(k) cleared radiology medical device. Manufacturer: Zirkonzahn Srl. Cleared Jul 2021. https://www.510kdatabase.net/k210129/ 2021-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k210129-rf-thermal-system-fda-510k.jpg K210129 - RF Thermal System K210129 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Luvo Medical Technologies, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k210349/ 2021-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k210349-tko-composite-bite-turbo-gel-fda-510k.jpg K210349 - TKO Composite Bite Turbo Gel K210349 is a FDA 510(k) cleared dental medical device. Manufacturer: Reliance Orthodontic Products, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k210666/ 2021-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k210666-chest-cad-fda-510k.jpg K210666 - Chest-CAD K210666 is a FDA 510(k) cleared radiology medical device. Manufacturer: Imagen Technologies, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k210684/ 2021-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k210684-disposable-nitrile-medical-examination-fda-510k.jpg K210684 - Disposable Nitrile Medical Examination Glove K210684 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Cureguard Glove Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k210719/ 2021-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k210719-change-healthcare-anatomical-ai-fda-510k.jpg K210719 - Change Healthcare Anatomical AI K210719 is a FDA 510(k) cleared radiology medical device. Manufacturer: Change Healthcare Canada Company. Cleared Jul 2021. https://www.510kdatabase.net/k211192/ 2021-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k211192-grivamax-family-of-lasers-models-272-fda-510k.jpg K211192 - Grivamax Family of Lasers, Models 272 and 148 K211192 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Leana Orders, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k211302/ 2021-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k211302-elecsys-syphilis-fda-510k.jpg K211302 - Elecsys Syphilis K211302 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Diagnostics. Cleared Jul 2021. https://www.510kdatabase.net/k211859/ 2021-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k211859-acuson-sequoia-diagnostic-ultrasound-fda-510k.jpg K211859 - ACUSON Sequoia Diagnostic Ultrasound System K211859 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k211906/ 2021-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k211906-vital-signs-fda-510k.jpg K211906 - Vital Signs K211906 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Oxehealth Limited. Cleared Jul 2021. https://www.510kdatabase.net/k201147/ 2021-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k201147-elos-intramedullary-nailing-system-fda-510k.jpg K201147 - Elos® Intramedullary Nailing System K201147 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Intrauma S.P.A. Cleared Jul 2021. https://www.510kdatabase.net/k210877/ 2021-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k210877-evolve-system-with-the-t3-applicator-fda-510k.jpg K210877 - Evolve System with the T3 Applicator K210877 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Inmode , Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k210963/ 2021-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k210963-ennovate-spinal-system-fda-510k.jpg K210963 - ENNOVATE Spinal System K210963 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aesculap Implant Systems, LLC. Cleared Jul 2021. https://www.510kdatabase.net/k211188/ 2021-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k211188-xvision-spine-system-xvs-fda-510k.jpg K211188 - xvision Spine system (XVS) K211188 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Augmedics, Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k211291/ 2021-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k211291-cube-navigation-system-virtueye-v2-fda-510k.jpg K211291 - Cube Navigation System, VirtuEye V2, Navigation Sensor NanoRest, Navigation Unit Cube 4D K211291 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Fiagon GmbH. Cleared Jul 2021. https://www.510kdatabase.net/k211548/ 2021-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k211548-polarstem-calcar-reamer-guide-fda-510k.jpg K211548 - POLARSTEM Calcar Reamer Guide K211548 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k211910/ 2021-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k211910-z-6-atrioseptostomy-catheter-fda-510k.jpg K211910 - Z-6 Atrioseptostomy Catheter K211910 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: NuMED, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k211177/ 2021-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k211177-powder-free-vinyl-patient-examination-fda-510k.jpg K211177 - Powder Free Vinyl Patient Examination Gloves K211177 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shijiazhuang Hongjun Plastic Manufacture Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k211239/ 2021-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k211239-vinyl-patient-examination-gloves-fda-510k.jpg K211239 - Vinyl Patient Examination Gloves K211239 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangxi Shengda Medical Technology Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k193397/ 2021-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k193397-advia-centaur-digoxin-assay-fda-510k.jpg K193397 - ADVIA Centaur® Digoxin assay K193397 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k201473/ 2021-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k201473-exoatlet-ii-fda-510k.jpg K201473 - ExoAtlet-II K201473 is a FDA 510(k) cleared neurology medical device. Manufacturer: Exoatlet Asia Co. , Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k203108/ 2021-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k203108-ignite-stemless-anatomic-shoulder-system-fda-510k.jpg K203108 - Ignite Stemless Anatomic Shoulder System K203108 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ignite Orthopedics, LLC. Cleared Jul 2021. https://www.510kdatabase.net/k203435/ 2021-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k203435-nihon-kohden-life-scope-g5-bedside-fda-510k.jpg K203435 - Nihon Kohden Life Scope G5 Bedside Monitoring System, Nihon Kohden Life Scope G7 Bedside Monitoring System K203435 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden Corporation. Cleared Jul 2021. https://www.510kdatabase.net/k210011/ 2021-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k210011-js-dental-lab-mouth-guard-fda-510k.jpg K210011 - JS Dental Lab Mouth Guard K210011 is a FDA 510(k) cleared dental medical device. Manufacturer: Ampower Dental Laboratories, LLC. Cleared Jul 2021. https://www.510kdatabase.net/k210103/ 2021-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k210103-safeway-lifelong-premium-lifelong-matrix-fda-510k.jpg K210103 - SAFEWAY, LIFELONG PREMIUM, LIFELONG MATRIX K210103 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Lifelong Meditech Private Limited. Cleared Jul 2021. https://www.510kdatabase.net/k210186/ 2021-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k210186-pacbond-one-fda-510k.jpg K210186 - PacBond One K210186 is a FDA 510(k) cleared dental medical device. Manufacturer: Pac-Dent, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k210544/ 2021-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k210544-medtronic-extended-infusion-set-fda-510k.jpg K210544 - Medtronic Extended infusion set K210544 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Unomedical A/S. Cleared Jul 2021. https://www.510kdatabase.net/k210761/ 2021-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k210761-velguard-surgical-face-mask-fda-510k.jpg K210761 - Velguard Surgical Face Mask K210761 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Esstee Exports Health Care Division. Cleared Jul 2021. https://www.510kdatabase.net/k211111/ 2021-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k211111-suremax-sa-cervical-standalone-system-fda-510k.jpg K211111 - SureMAX-SA Cervical Standalone System K211111 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Additive Implants, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k211525/ 2021-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k211525-swiftninja-steerable-microcatheter-fda-510k.jpg K211525 - SwiftNINJA Steerable Microcatheter K211525 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k211592/ 2021-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k211592-avanti-orthopaedics-ulnar-shortening-fda-510k.jpg K211592 - Avanti Orthopaedics Ulnar Shortening System K211592 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Avanti Orthopaedics, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k211792/ 2021-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k211792-stitchkit-fda-510k.jpg K211792 - StitchKit K211792 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Origami Surgical Inc .. Cleared Jul 2021. https://www.510kdatabase.net/k211946/ 2021-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k211946-soniquence-reusable-bipolar-cable-fda-510k.jpg K211946 - Soniquence Reusable Bipolar Cable K211946 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Soniquence, LLC. Cleared Jul 2021. https://www.510kdatabase.net/k200096/ 2021-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k200096-crosstex-vh2o2-chemical-indicators-fda-510k.jpg K200096 - Crosstex VH2O2 Chemical Indicators K200096 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Crosstex International, Inc. (A Cantel Medical Company). Cleared Jul 2021. https://www.510kdatabase.net/k201100/ 2021-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k201100-bio-medicus-life-support-catheter-and-fda-510k.jpg K201100 - Bio-Medicus Life Support Catheter and Introducer K201100 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k201328/ 2021-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k201328-dexcom-g6-continuous-glucose-fda-510k.jpg K201328 - Dexcom G6 Continuous Glucose Monitoring (CGM) System K201328 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dexcom, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k202638/ 2021-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k202638-pain-therapy-device-fda-510k.jpg K202638 - Pain Therapy Device K202638 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Guangzhou Xinbo Electronic Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k202846/ 2021-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k202846-tera-harz-fda-510k.jpg K202846 - TERA HARZ K202846 is a FDA 510(k) cleared dental medical device. Manufacturer: Graphy, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k210431/ 2021-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k210431-recross-fda-510k.jpg K210431 - ReCross K210431 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Imds Operations B.V.. Cleared Jul 2021. https://www.510kdatabase.net/k210750/ 2021-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k210750-acumed-clavicle-hook-plating-system-fda-510k.jpg K210750 - Acumed Clavicle Hook Plating System K210750 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Acumed, LLC. Cleared Jul 2021. https://www.510kdatabase.net/k211042/ 2021-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k211042-disposable-procedural-ear-loop-face-mask-fda-510k.jpg K211042 - Disposable Procedural Ear-loop Face Mask K211042 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Changzhou Dsb Medical Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k211514/ 2021-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k211514-longeviti-porousfit-implant-fda-510k.jpg K211514 - Longeviti PorousFit implant K211514 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Longeviti Neuro Solutions, LLC. Cleared Jul 2021. https://www.510kdatabase.net/k211547/ 2021-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k211547-edma-nitrile-examination-gloves-tested-fda-510k.jpg K211547 - Edma Nitrile Examination Gloves (Tested for Use with Chemotherapy Drugs) K211547 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Edma Group, LLC. Cleared Jul 2021. https://www.510kdatabase.net/k211933/ 2021-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k211933-elevation-breast-biopsy-system-fda-510k.jpg K211933 - EleVation Breast Biopsy System K211933 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bard Peripheral Vascular. Cleared Jul 2021. https://www.510kdatabase.net/k193047/ 2021-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k193047-n-latex-flc-kappa-n-latex-flc-lambda-fda-510k.jpg K193047 - N Latex FLC kappa, N Latex FLC lambda K193047 is a FDA 510(k) cleared immunology medical device. Manufacturer: Siemens Healthcare Diagnostics Products GmbH. Cleared Jul 2021. https://www.510kdatabase.net/k200983/ 2021-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k200983-infrared-light-therapy-led-facial-fda-510k.jpg K200983 - Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine K200983 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ningbo Hesi Electric Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k201733/ 2021-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k201733-provident-ii-hip-stems-fda-510k.jpg K201733 - Provident II Hip Stems K201733 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k201844/ 2021-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k201844-surgical-face-mask-surgical-mask-fda-510k.jpg K201844 - Surgical Face Mask, Surgical Mask K201844 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Lear Corporation. Cleared Jul 2021. https://www.510kdatabase.net/k202067/ 2021-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k202067-elia-smdp-s-fda-510k.jpg K202067 - EliA SmDP-S K202067 is a FDA 510(k) cleared immunology medical device. Manufacturer: Phadia AB. Cleared Jul 2021. https://www.510kdatabase.net/k202304/ 2021-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k202304-nyu-langone-genome-pact-genome-fda-510k.jpg K202304 - NYU Langone Genome PACT (Genome Profiling of Actionable Cancer Targets) K202304 is a FDA 510(k) cleared pathology medical device. Manufacturer: Nyu Langone Medical Center. Cleared Jul 2021. https://www.510kdatabase.net/k202390/ 2021-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k202390-aduro-light-beauty-mask-fda-510k.jpg K202390 - Aduro Light Beauty Mask K202390 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Kaiyan Medical CO , Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k202918/ 2021-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k202918-osteosync-ti-dental-mesh-fda-510k.jpg K202918 - OsteoSync™ Ti Dental Mesh K202918 is a FDA 510(k) cleared dental medical device. Manufacturer: Sites Medical, LLC. Cleared Jul 2021. https://www.510kdatabase.net/k202989/ 2021-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k202989-myopia-master-fda-510k.jpg K202989 - Myopia Master K202989 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Oculus Optikger?te GmbH. Cleared Jul 2021. https://www.510kdatabase.net/k203023/ 2021-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k203023-pisces-spinal-system-fda-510k.jpg K203023 - Pisces Spinal System K203023 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ortho Development Corporation. Cleared Jul 2021. https://www.510kdatabase.net/k203115/ 2021-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k203115-arvis-surgical-navigation-system-fda-510k.jpg K203115 - ARVIS Surgical Navigation System K203115 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Insight Medical Systems, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k203496/ 2021-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k203496-nexo-gide-bilayer-collagen-membrane-fda-510k.jpg K203496 - Nexo-Gide Bilayer Collagen Membrane K203496 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Geistlich Pharma AG. Cleared Jul 2021. https://www.510kdatabase.net/k203509/ 2021-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k203509-smart-finder-fda-510k.jpg K203509 - SMART FINDER K203509 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ims Giotto S.P.A.. Cleared Jul 2021. https://www.510kdatabase.net/k203728/ 2021-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k203728-darwin-fda-510k.jpg K203728 - Darwin K203728 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Luvo Medical Technologies, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k211866/ 2021-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k211866-bencox-thr-system-fda-510k.jpg K211866 - Bencox THR System K211866 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corentec Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k192739/ 2021-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k192739-electric-wheelchair-models-fda-510k.jpg K192739 - Electric Wheelchair [Models: JRWD6010/JRWD6012] K192739 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Jerry Medical Instrument (Shanghai) Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k200210/ 2021-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k200210-advia-centaur-total-hcg-assay-fda-510k.jpg K200210 - ADVIA Centaur® Total hCG assay K200210 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k203562/ 2021-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k203562-finetest-lite-blood-glucose-monitoring-fda-510k.jpg K203562 - Finetest Lite Blood Glucose Monitoring System K203562 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Osang Healthcare Co. , Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k211237/ 2021-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k211237-ultratemp-rez-ii-fda-510k.jpg K211237 - UltraTemp Rez II K211237 is a FDA 510(k) cleared dental medical device. Manufacturer: Ultradent Products, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k211938/ 2021-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k211938-physica-lmc-knee-system-fda-510k.jpg K211938 - Physica LMC Knee System K211938 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Limacorporate. Cleared Jul 2021. https://www.510kdatabase.net/k203556/ 2021-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k203556-medtronic-model-5492a-5492v-5492al-fda-510k.jpg K203556 - Medtronic Model 5492A, 5492V, 5492AL, 5492VL Patient Cables K203556 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k210244/ 2021-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k210244-disposable-medical-face-mask-fda-510k.jpg K210244 - Disposable Medical Face Mask K210244 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Suzhou Bolisi Medical Technology Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k210386/ 2021-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k210386-magneto-nasal-mask-fda-510k.jpg K210386 - Magneto Nasal Mask K210386 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k210492/ 2021-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k210492-inmode-rf-pro-system-fda-510k.jpg K210492 - InMode RF Pro System K210492 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Inmode MD , Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k210717/ 2021-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k210717-bone-screws-dia-50-mm-fda-510k.jpg K210717 - Bone Screws dia. 5,0 mm K210717 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Lima Corporate S.P.A.. Cleared Jul 2021. https://www.510kdatabase.net/k210723/ 2021-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k210723-nitrile-patient-examination-glove-fda-510k.jpg K210723 - Nitrile Patient Examination Glove K210723 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangxi Zhonghong Pulin Medical Products Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k210776/ 2021-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k210776-nitrile-examination-gloves-fda-510k.jpg K210776 - Nitrile Examination Gloves K210776 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 5r Med Instruments (Chengdu) Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k211113/ 2021-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k211113-zavation-spinal-system-fda-510k.jpg K211113 - Zavation Spinal System K211113 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zavation Medical Products, LLC. Cleared Jul 2021. https://www.510kdatabase.net/k211491/ 2021-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k211491-radiforce-rx370-fda-510k.jpg K211491 - RadiForce RX370 K211491 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eizo Corporation. Cleared Jul 2021. https://www.510kdatabase.net/k211495/ 2021-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k211495-eos-pmp-fda-510k.jpg K211495 - EOS PMP K211495 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sorin Group Italia S.R.L.. Cleared Jul 2021. https://www.510kdatabase.net/k211506/ 2021-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k211506-powerlook-density-assessment-v40-fda-510k.jpg K211506 - PowerLook Density Assessment V4.0 K211506 is a FDA 510(k) cleared radiology medical device. Manufacturer: Icad, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/den200039/ 2021-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/den200039-inspace-subacromial-tissue-spacer-system-fda-510k.jpg DEN200039 - InSpace Subacromial Tissue Spacer System DEN200039 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ortho-Space , Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k210578/ 2021-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k210578-medical-nitrile-examination-gloves-fda-510k.jpg K210578 - Medical Nitrile Examination Gloves (Power free, Blue) K210578 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangxi Hongda Medical Equipment Group , Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k200575/ 2021-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k200575-truemed-hand-foot-and-ankle-plates-fda-510k.jpg K200575 - TRUEMED HAND, FOOT AND ANKLE PLATES SYSTEM K200575 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Truemed Group, LLC. Cleared Jul 2021. https://www.510kdatabase.net/k200915/ 2021-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k200915-powder-free-white-sterilized-fda-510k.jpg K200915 - Powder Free White Sterilized Polyisoprene Surgical Gloves-Tested for Use with The Chemotherapy Drugs K200915 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Gx Corporation Sdn Bhd. Cleared Jul 2021. https://www.510kdatabase.net/k201262/ 2021-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k201262-microwave-therapeutic-system-fda-510k.jpg K201262 - Microwave Therapeutic System K201262 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Nanjing Eco Microwave System Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k201675/ 2021-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k201675-vitek-2-ast-gram-negative-meropenem-fda-510k.jpg K201675 - VITEK 2 AST-Gram Negative Meropenem (<= 0.25 - >=16 µg/mL) K201675 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k202517/ 2021-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k202517-cytrellis-dermal-micro-coring-system-fda-510k.jpg K202517 - Cytrellis Dermal Micro-Coring System K202517 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cytrellis Biosystems, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k210012/ 2021-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k210012-tamarin-blue-ptca-rx-dilatation-catheter-fda-510k.jpg K210012 - Tamarin Blue PTCA RX Dilatation Catheter K210012 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Natec Medical , Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k210602/ 2021-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k210602-aortastat-occlusion-device-fda-510k.jpg K210602 - AortaSTAT Occlusion Device K210602 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Renalpro Medical, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k210607/ 2021-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k210607-palacos-r-pro-palacos-rg-pro-palacos-fda-510k.jpg K210607 - PALACOS R pro, PALACOS R+G pro, PALACOS MV+G pro K210607 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Heraeus Medical GmbH. Cleared Jul 2021. https://www.510kdatabase.net/k210713/ 2021-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k210713-hm70-evo-diagnostic-ultrasound-system-fda-510k.jpg K210713 - HM70 EVO Diagnostic Ultrasound System K210713 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Medison Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k210821/ 2021-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k210821-medical-pvc-examination-gloves-fda-510k.jpg K210821 - Medical PVC Examination Gloves K210821 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangxi Hongda Medical Equipment Group , Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k211088/ 2021-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k211088-grosz-play-feel-fda-510k.jpg K211088 - Grosz Play Feel K211088 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Rb Health (Us), LLC. Cleared Jul 2021. https://www.510kdatabase.net/k211107/ 2021-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k211107-btl-899-fp-fda-510k.jpg K211107 - BTL-899 FP K211107 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: BTL Industries, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k211493/ 2021-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k211493-monarch-platform-fda-510k.jpg K211493 - Monarch Platform K211493 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Auris Health, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k211542/ 2021-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k211542-primo-s-fda-510k.jpg K211542 - PRIMO S K211542 is a FDA 510(k) cleared radiology medical device. Manufacturer: A.T.S. Applicazione Tecnologie Speciali S.R.L.. Cleared Jul 2021. https://www.510kdatabase.net/k211574/ 2021-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k211574-extreme-x8-fda-510k.jpg K211574 - Extreme X8 K211574 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Magic Mobility. Cleared Jul 2021. https://www.510kdatabase.net/k192971/ 2021-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k192971-nebulizer-kit-fda-510k.jpg K192971 - Nebulizer Kit K192971 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Excellentcare Medical (Huizhou) , Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k193490/ 2021-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k193490-sensitox-c-difficile-toxin-test-fda-510k.jpg K193490 - SensiTox C. difficile Toxin Test K193490 is a FDA 510(k) cleared microbiology medical device. Manufacturer: First Light Diagnostics, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k201835/ 2021-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k201835-pre-sure-fda-510k.jpg K201835 - PRE-SURE K201835 is a FDA 510(k) cleared radiology medical device. Manufacturer: Lazarus 3D, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k202579/ 2021-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k202579-truabutment-ds-trubase-fda-510k.jpg K202579 - TruAbutment DS, TruBase K202579 is a FDA 510(k) cleared dental medical device. Manufacturer: Truabutment, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k202922/ 2021-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k202922-end-200-endoscopic-tubeset-fda-510k.jpg K202922 - END 200 Endoscopic Tubeset K202922 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Palliare , Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k203148/ 2021-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k203148-youha-electric-breast-pump-models-the-fda-510k.jpg K203148 - Youha Electric Breast Pump (Models: THE ONE, YH-8011, YH-8012, YH-8019, YY-5030) K203148 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ningbo Youhe Electrical Appliance Technology Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k203158/ 2021-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k203158-biowave-biowraps-fda-510k.jpg K203158 - BioWave BioWraps K203158 is a FDA 510(k) cleared neurology medical device. Manufacturer: Biowave Corporation. Cleared Jul 2021. https://www.510kdatabase.net/k203659/ 2021-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k203659-isrobot-mona-lisa-10-fda-510k.jpg K203659 - iSR'obot Mona Lisa 1.0 K203659 is a FDA 510(k) cleared radiology medical device. Manufacturer: Biobot Surgical Pte., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k210104/ 2021-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k210104-surroundscope-system-fda-510k.jpg K210104 - SurroundScope System K210104 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: 270surgical , Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k210267/ 2021-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k210267-disposable-surgical-mask-fda-510k.jpg K210267 - Disposable Surgical Mask K210267 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Xiamen Eagledon Pharmaceutical Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k210380/ 2021-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k210380-medical-surgical-mask-fda-510k.jpg K210380 - Medical surgical mask K210380 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shantou T&K Medical Equipment Factory Co.,Ltd. Cleared Jul 2021. https://www.510kdatabase.net/k210945/ 2021-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k210945-ultra-sep-fda-510k.jpg K210945 - Ultra SEP K210945 is a FDA 510(k) cleared dental medical device. Manufacturer: Reliance Orthodontic Products, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k211052/ 2021-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k211052-straumann-ridgefit-implants-fda-510k.jpg K211052 - Straumann RidgeFit Implants K211052 is a FDA 510(k) cleared dental medical device. Manufacturer: Institut Straumann AG. Cleared Jul 2021. https://www.510kdatabase.net/k211094/ 2021-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k211094-nerve-and-muscle-stimulator-fda-510k.jpg K211094 - Nerve and Muscle Stimulator K211094 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Shenzhen Xft Medical Limited. Cleared Jul 2021. https://www.510kdatabase.net/k211442/ 2021-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k211442-stealthstation-spinous-process-clamps-fda-510k.jpg K211442 - StealthStation Spinous Process Clamps K211442 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Navigation. Cleared Jul 2021. https://www.510kdatabase.net/k211465/ 2021-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k211465-hemosphere-advanced-monitor-viewfinder-fda-510k.jpg K211465 - HemoSphere Advanced Monitor, Viewfinder Remote, HemoSphere Advanced Monitoring Platform K211465 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lfesciences. Cleared Jul 2021. https://www.510kdatabase.net/k211480/ 2021-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k211480-nubex-fda-510k.jpg K211480 - NubeX K211480 is a FDA 510(k) cleared radiology medical device. Manufacturer: Techheim Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k211788/ 2021-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k211788-halo-fda-510k.jpg K211788 - HALO K211788 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nicolab B.V.. Cleared Jul 2021. https://www.510kdatabase.net/k201726/ 2021-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k201726-arterial-catheter-fda-510k.jpg K201726 - Arterial Catheter K201726 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Haolang Medical USA Corporation. Cleared Jul 2021. https://www.510kdatabase.net/k201740/ 2021-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k201740-hydrozid-fda-510k.jpg K201740 - Hydrozid K201740 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medilink A/S. Cleared Jul 2021. https://www.510kdatabase.net/k202741/ 2021-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k202741-infrared-forehead-thermometer-fda-510k.jpg K202741 - Infrared Forehead Thermometer K202741 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen Combei Technology Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k203003/ 2021-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k203003-pantheon-ibfd-fda-510k.jpg K203003 - Pantheon IBFD K203003 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Pantheon Spinal. Cleared Jul 2021. https://www.510kdatabase.net/k203432/ 2021-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k203432-axium-detachable-coil-fda-510k.jpg K203432 - Axium Detachable Coil K203432 is a FDA 510(k) cleared neurology medical device. Manufacturer: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. Cleared Jul 2021. https://www.510kdatabase.net/k210215/ 2021-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k210215-surgical-gowns-fda-510k.jpg K210215 - Surgical Gowns K210215 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Province Jianerkang Medical Dressing Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k210497/ 2021-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k210497-seaspine-spacer-system-nm-hollywood-fda-510k.jpg K210497 - SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L NanoMetalene, SeaSpine Vu e•POD System, SeaSpine Vu a•POD Prime NanoMetalene Intervertebral, SeaSpine Shoreline ACS - Anterior Cervical Standalone, SeaSpine Cervical Interbody RT System, SeaSpine Cambria System, SeaSpine Regatta Lateral System, SeaSpine Reef TO/TA System, SeaSpine Reef TH System, SeaSpine Meridian System K210497 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared Jul 2021. https://www.510kdatabase.net/k210524/ 2021-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k210524-surgical-mask-fda-510k.jpg K210524 - Surgical Mask K210524 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Changzhou Holymed Products Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k210653/ 2021-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k210653-one-planner-hip-fda-510k.jpg K210653 - ONE Planner Hip K210653 is a FDA 510(k) cleared radiology medical device. Manufacturer: Orthosoft D/B/A Zimmer Cas. Cleared Jul 2021. https://www.510kdatabase.net/k211002/ 2021-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k211002-grappler-suture-anchor-system-fda-510k.jpg K211002 - Grappler Suture Anchor System K211002 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paragon 28, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k211818/ 2021-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k211818-swoop-point-of-care-magnetic-resonance-fda-510k.jpg K211818 - Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System K211818 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hyperfine, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k193622/ 2021-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k193622-trioclear-system-fda-510k.jpg K193622 - TRIOCLEAR System K193622 is a FDA 510(k) cleared dental medical device. Manufacturer: Perfection Aligner System Hong Kong Limited. Cleared Jul 2021. https://www.510kdatabase.net/k203198/ 2021-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k203198-karl-storz-metal-sterilization-trays-fda-510k.jpg K203198 - KARL STORZ Metal Sterilization Trays K203198 is a FDA 510(k) cleared general hospital medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k203309/ 2021-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k203309-nuvo-cf-implant-system-fda-510k.jpg K203309 - NUVO CF Implant System K203309 is a FDA 510(k) cleared dental medical device. Manufacturer: JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A.. Cleared Jul 2021. https://www.510kdatabase.net/k203459/ 2021-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k203459-safecross-transseptal-puncture-and-fda-510k.jpg K203459 - SafeCross Transseptal Puncture and Introducer (TSP/I) System K203459 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: East End Medical I, LLC. Cleared Jul 2021. https://www.510kdatabase.net/k210480/ 2021-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k210480-acupebble-sa-fda-510k.jpg K210480 - AcuPebble SA K210480 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Acurable Limited. Cleared Jul 2021. https://www.510kdatabase.net/k211821/ 2021-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k211821-deka-motus-az-fda-510k.jpg K211821 - DEKA Motus AZ K211821 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: El.En Electronic Engineering Spa. Cleared Jul 2021. https://www.510kdatabase.net/k200256/ 2021-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k200256-advia-chemistry-enzymatic-hemoglobin-fda-510k.jpg K200256 - ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay K200256 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k202241/ 2021-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k202241-lykos-assisted-reproduction-laser-with-fda-510k.jpg K202241 - LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS) K202241 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Hamilton Thorne, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k202570/ 2021-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k202570-insulin-syringe-insulin-syringe-with-fda-510k.jpg K202570 - Insulin Syringe, Insulin Syringe with Safety Retractable K202570 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Micsafe Medical Technology Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k202954/ 2021-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k202954-disposable-surgical-mask-fda-510k.jpg K202954 - Disposable Surgical Mask K202954 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Xiamen Probtain Medical Techology Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k203347/ 2021-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k203347-sleep-apnea-breathing-therapy-mask-yf-fda-510k.jpg K203347 - Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03 Full Face Mask, YN-02 Nasal Mask, YN-03 Nasal Mask, YP-01 Nasal Pillow Mask K203347 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Suzhou Yuyue Medical Technology Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k203441/ 2021-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k203441-the-alma-hybrid-laser-system-fda-510k.jpg K203441 - The Alma Hybrid Laser System K203441 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Alma Lasers , Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k203498/ 2021-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k203498-lx9max-fda-510k.jpg K203498 - LX9max K203498 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Daesung Maref Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k203591/ 2021-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k203591-single-use-medical-face-mask-fda-510k.jpg K203591 - Single-use Medical Face Mask K203591 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Conod Medical Co., Limited. Cleared Jul 2021. https://www.510kdatabase.net/k203800/ 2021-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k203800-syntrfuge-system-fda-510k.jpg K203800 - SyntrFuge System K203800 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Syntr Health Technologies, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k210097/ 2021-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k210097-estar-z-fda-510k.jpg K210097 - Estar-Z K210097 is a FDA 510(k) cleared dental medical device. Manufacturer: Osstem Implant Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k210127/ 2021-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k210127-iq200-system-ichemvelocity-automated-fda-510k.jpg K210127 - iQ200 System, iChemVELOCITY Automated Urine Chemistry System K210127 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k210199/ 2021-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k210199-ricoh-meg-fda-510k.jpg K210199 - RICOH MEG K210199 is a FDA 510(k) cleared neurology medical device. Manufacturer: Ricoh Company, Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k211393/ 2021-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k211393-selethrutm-nc-ptca-balloon-dilatation-fda-510k.jpg K211393 - Selethru(TM) NC PTCA Balloon Dilatation Catheter K211393 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Kossel Medtech (Suzhou) Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k211422/ 2021-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k211422-level-2-standard-surgical-gown-level-3-fda-510k.jpg K211422 - Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown K211422 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Medplus Non-Woven Manufacturer Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k202171/ 2021-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k202171-pulmogine-vibrating-mesh-nebulizer-fda-510k.jpg K202171 - Pulmogine Vibrating Mesh Nebulizer K202171 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Hcmed Innovations Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k203262/ 2021-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k203262-cannula-for-organ-perfusion-fda-510k.jpg K203262 - Cannula for Organ Perfusion K203262 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Bridge TO Life, Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k203369/ 2021-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k203369-avance-solo-negative-pressure-wound-fda-510k.jpg K203369 - Avance Solo Negative Pressure Wound Therapy (NPWT) System K203369 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Molnlycke Health Care Us, LLC. Cleared Jul 2021. https://www.510kdatabase.net/k203575/ 2021-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k203575-glidepath-retro-long-term-hemodialysis-fda-510k.jpg K203575 - GlidePath Retro Long-Term Hemodialysis Catheter K203575 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k203672/ 2021-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k203672-mazic-claro-cad-and-mazic-claro-press-fda-510k.jpg K203672 - MAZIC Claro CAD and MAZIC Claro Press K203672 is a FDA 510(k) cleared dental medical device. Manufacturer: Vericom Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k210326/ 2021-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k210326-bravo-g4-chamber-autoclave-fda-510k.jpg K210326 - Bravo G4 Chamber Autoclave K210326 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Scican , Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k210611/ 2021-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k210611-magnetom-freemax-fda-510k.jpg K210611 - MAGNETOM Free.Max K210611 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k210910/ 2021-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k210910-snore-bandit-fda-510k.jpg K210910 - Snore Bandit K210910 is a FDA 510(k) cleared dental medical device. Manufacturer: Snorebandit, LLC. Cleared Jul 2021. https://www.510kdatabase.net/k211007/ 2021-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k211007-ez-traxtm-persona-knee-containment-fda-510k.jpg K211007 - EZ-TRAXTM Persona Knee Containment Device K211007 is a FDA 510(k) cleared general hospital medical device. Manufacturer: K1 Medical, LLC. Cleared Jul 2021. https://www.510kdatabase.net/k211337/ 2021-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k211337-dc-70dc-70tdc-70-prodc-70-expdc-75dc-fda-510k.jpg K211337 - DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System K211337 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Jul 2021. https://www.510kdatabase.net/k211411/ 2021-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k211411-penumbra-system-red-68-reperfusion-fda-510k.jpg K211411 - Penumbra System (RED 68 Reperfusion Catheter) K211411 is a FDA 510(k) cleared neurology medical device. Manufacturer: Penumbra, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k211511/ 2021-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k211511-decimal-bolus-fda-510k.jpg K211511 - decimal Bolus K211511 is a FDA 510(k) cleared radiology medical device. Manufacturer: .Decimal, LLC. Cleared Jul 2021. https://www.510kdatabase.net/k211782/ 2021-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k211782-controlrad-select-model-z-controlrad-fda-510k.jpg K211782 - ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9 K211782 is a FDA 510(k) cleared radiology medical device. Manufacturer: Controlrad, Inc.. Cleared Jul 2021. https://www.510kdatabase.net/k201206/ 2021-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k201206-pivot-breath-sensor-fda-510k.jpg K201206 - Pivot Breath Sensor K201206 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Carrot, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k203057/ 2021-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k203057-quantum-perfusion-arterial-cannula-graft-fda-510k.jpg K203057 - Quantum Perfusion Arterial Cannula Graft K203057 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Qura S.R.L. Cleared Jun 2021. https://www.510kdatabase.net/k203717/ 2021-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k203717-processor-vp-7000-light-source-bl-fda-510k.jpg K203717 - Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0 K203717 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Fujifilm Corporaton. Cleared Jun 2021. https://www.510kdatabase.net/k210044/ 2021-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k210044-crystal-spinal-system-vertu-spinal-fda-510k.jpg K210044 - Crystal Spinal System & Vertu Spinal System, Lucent Spinal System, Zeus Spinal System, Ceres-C Spinal System, Omega XP Spinal System K210044 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinal Elements, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k210377/ 2021-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k210377-stryker-ibur-hubs-and-cutting-fda-510k.jpg K210377 - Stryker iBur hubs and cutting accessories K210377 is a FDA 510(k) cleared neurology medical device. Manufacturer: Stryker Corporation. Cleared Jun 2021. https://www.510kdatabase.net/k210512/ 2021-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k210512-luminelle-dtx-system-fda-510k.jpg K210512 - LUMINELLE DTx System K210512 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Uvision360, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k210542/ 2021-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k210542-aprevo-transforaminal-ibf-fda-510k.jpg K210542 - aprevo Transforaminal IBF K210542 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Carlsmed, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k210560/ 2021-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k210560-page-writer-tc20-cardiograph-page-fda-510k.jpg K210560 - Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph K210560 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Philips Medical Systems. Cleared Jun 2021. https://www.510kdatabase.net/k210753/ 2021-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k210753-kardiamobile-6l-fda-510k.jpg K210753 - KardiaMobile 6L K210753 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: AliveCor, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k210904/ 2021-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k210904-metapaste-plus-fda-510k.jpg K210904 - Metapaste Plus K210904 is a FDA 510(k) cleared dental medical device. Manufacturer: Meta Biomed Co., Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k211025/ 2021-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k211025-oralenteral-syringe-with-enfit-connector-fda-510k.jpg K211025 - Oral/Enteral Syringe with ENFit connector K211025 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ningbo Tianyi Medical Appliance Co., Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k211768/ 2021-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k211768-link-endo-model-knee-system-femoral-fda-510k.jpg K211768 - LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE K211768 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Waldemar Link GmbH & Co. KG. Cleared Jun 2021. https://www.510kdatabase.net/k203645/ 2021-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k203645-aixplorer-mach30-supersonic-mach30-fda-510k.jpg K203645 - Aixplorer MACH30/ SUPERSONIC MACH30, Aixplorer MACH20/ SUPERSONIC MACH20, SUPERSONIC MACH40 K203645 is a FDA 510(k) cleared radiology medical device. Manufacturer: Supersonic Imagine. Cleared Jun 2021. https://www.510kdatabase.net/k203733/ 2021-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k203733-12mp-color-digital-mammography-lcd-fda-510k.jpg K203733 - 12MP Color Digital Mammography LCD Monitor CL-S1200 K203733 is a FDA 510(k) cleared radiology medical device. Manufacturer: Jvckenwood Corporation. Cleared Jun 2021. https://www.510kdatabase.net/k210437/ 2021-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k210437-standard-bougie-38-fr-fda-510k.jpg K210437 - Standard Bougie, 38 Fr. K210437 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Standard Bariatrics. Cleared Jun 2021. https://www.510kdatabase.net/k210445/ 2021-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k210445-nordiwell-surprotect-face-mask-fda-510k.jpg K210445 - Nordiwell Surprotect Face Mask K210445 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Changzhou Combat Protective Equipment Co., Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k210645/ 2021-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k210645-raystation-101-fda-510k.jpg K210645 - RayStation 10.1 K210645 is a FDA 510(k) cleared radiology medical device. Manufacturer: RaySearch Laboratories AB (PUBL). Cleared Jun 2021. https://www.510kdatabase.net/k210837/ 2021-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k210837-smith-nephew-plates-and-screws-fda-510k.jpg K210837 - Smith & Nephew Plates and Screws K210837 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k210843/ 2021-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k210843-stage-fda-510k.jpg K210843 - STAGE K210843 is a FDA 510(k) cleared radiology medical device. Manufacturer: Spintech, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k210954/ 2021-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k210954-synergy-fda-510k.jpg K210954 - Synergy K210954 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Yrs Group, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k211038/ 2021-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k211038-biophotas-celluma-restore-fda-510k.jpg K211038 - Biophotas Celluma RESTORE K211038 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Biophotas, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k201353/ 2021-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k201353-centermed-patient-matched-assisted-fda-510k.jpg K201353 - CenterMed Patient Matched Assisted Surgical Planning (ASP) System K201353 is a FDA 510(k) cleared dental medical device. Manufacturer: Centermed, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k203410/ 2021-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k203410-enfit-disposable-enteral-syringe-fda-510k.jpg K203410 - ENFit Disposable Enteral Syringe K203410 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Shantou Wealy Medical Instrument Co.,Ltd. Cleared Jun 2021. https://www.510kdatabase.net/k210421/ 2021-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k210421-diafil-diafil-capsule-fda-510k.jpg K210421 - Diafil & Diafil Capsule K210421 is a FDA 510(k) cleared dental medical device. Manufacturer: DiaDent Group International. Cleared Jun 2021. https://www.510kdatabase.net/k210587/ 2021-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k210587-violet-nitrile-powder-free-patient-fda-510k.jpg K210587 - Violet Nitrile Powder Free Patient Examination Glove, Non Sterile K210587 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Onetexx Sdn Bhd. Cleared Jun 2021. https://www.510kdatabase.net/k210775/ 2021-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k210775-white-nitrile-powder-free-patient-fda-510k.jpg K210775 - White Nitrile Powder Free Patient Examination Glove, Non Sterile K210775 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Onetexx Sdn Bhd. Cleared Jun 2021. https://www.510kdatabase.net/k210869/ 2021-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k210869-phantom-hindfoot-ttctc-nail-system-fda-510k.jpg K210869 - Phantom Hindfoot TTC/TC Nail System K210869 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paragon 28, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k201196/ 2021-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k201196-scooter-model-fdb01-fda-510k.jpg K201196 - Scooter (Model: FDB01) K201196 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Nanjing Jin Bai HE Medical Apparatus Co., Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k201228/ 2021-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k201228-psychemedics-homogeneous-enzyme-fda-510k.jpg K201228 - Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair K201228 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Psychemedics Corporation. Cleared Jun 2021. https://www.510kdatabase.net/k203657/ 2021-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k203657-vu-path-ultrasound-system-fda-510k.jpg K203657 - Vu-Path Ultrasound System K203657 is a FDA 510(k) cleared radiology medical device. Manufacturer: Crystalline Medical. Cleared Jun 2021. https://www.510kdatabase.net/k210098/ 2021-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k210098-purastat-gi-fda-510k.jpg K210098 - PuraStat-GI K210098 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3-D Matrix, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k210138/ 2021-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k210138-itind-system-fda-510k.jpg K210138 - iTind System K210138 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medi-Tate , Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k210889/ 2021-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k210889-ilab-polaris-multi-modality-guidance-fda-510k.jpg K210889 - iLab Polaris Multi-Modality Guidance System K210889 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Jun 2021. https://www.510kdatabase.net/k211193/ 2021-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k211193-bd-prevue-ii-peripheral-vascular-fda-510k.jpg K211193 - BD Prevue II Peripheral Vascular Vascular Access System K211193 is a FDA 510(k) cleared radiology medical device. Manufacturer: Bard Access Systems, Inc. (C.R. Bard, Inc.). Cleared Jun 2021. https://www.510kdatabase.net/k211232/ 2021-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k211232-apache-ultrasound-system-fda-510k.jpg K211232 - Apache Ultrasound System K211232 is a FDA 510(k) cleared radiology medical device. Manufacturer: Aco Healthcare Co., Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k211238/ 2021-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k211238-spinejack-expansion-kit-vertaplex-fda-510k.jpg K211238 - SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement K211238 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Instruments. Cleared Jun 2021. https://www.510kdatabase.net/k211252/ 2021-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k211252-nitrile-glove-fda-510k.jpg K211252 - Nitrile Glove K211252 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Dihong Industry and Trade Co., Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k211293/ 2021-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k211293-safety-winged-blood-collection-sets-fda-510k.jpg K211293 - Safety Winged Blood Collection Sets K211293 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Promisemed Hangzhou Meditech Co., Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k211656/ 2021-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k211656-3d-echo-v11-fda-510k.jpg K211656 - 3D Echo v1.1 K211656 is a FDA 510(k) cleared radiology medical device. Manufacturer: Jointvue, LLC. Cleared Jun 2021. https://www.510kdatabase.net/k201428/ 2021-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k201428-powder-free-black-nitrile-examination-fda-510k.jpg K201428 - Powder Free Black Nitrile Examination Glove K201428 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Vietglove Corporation. Cleared Jun 2021. https://www.510kdatabase.net/k202196/ 2021-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k202196-biofire-rp21rp21plus-control-panel-m441-fda-510k.jpg K202196 - BioFire RP2.1/RP2.1plus Control Panel M441 K202196 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Maine Molecular Quality Controls, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k202523/ 2021-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k202523-tmj-relax-fda-510k.jpg K202523 - TMJ Relax K202523 is a FDA 510(k) cleared dental medical device. Manufacturer: Moonwalker Innovations, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k202551/ 2021-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k202551-cor-knot-micro-fda-510k.jpg K202551 - Cor-Knot Micro K202551 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lsi Solutions, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k202897/ 2021-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k202897-natural-cycles-fda-510k.jpg K202897 - Natural Cycles K202897 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Natural Cycles Nordic AB. Cleared Jun 2021. https://www.510kdatabase.net/k203375/ 2021-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k203375-ovomotion-reverse-shoulder-fda-510k.jpg K203375 - OVOMotion Reverse Shoulder Arthroplasty System K203375 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrosurface, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k203590/ 2021-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k203590-perfit-fs-dental-zirconia-fully-fda-510k.jpg K203590 - Perfit FS Dental Zirconia Fully Sintered Block K203590 is a FDA 510(k) cleared dental medical device. Manufacturer: Vatech Acucera, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k210423/ 2021-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k210423-werewolf-coblation-system-werewolf-fda-510k.jpg K210423 - Werewolf+ Coblation System, Werewolf+ Controller, Werewolf Fastseal 6.0 Hemostasis Wand K210423 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: ArthroCare Corporation. Cleared Jun 2021. https://www.510kdatabase.net/k210656/ 2021-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k210656-encore-latex-ortho-powder-free-latex-fda-510k.jpg K210656 - ENCORE Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs, GAMMEX Latex Ortho, Powder Free Latex Surgical Gloves with Protein Content Labeling Claim (<50 µg/dm2 per glove of total aqueous extractable protein) and Tested for use with Chemotherapy drugs K210656 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Careplus (M) Sdn Bhd. Cleared Jun 2021. https://www.510kdatabase.net/k210909/ 2021-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k210909-easyendo-lite-linear-cutting-stapler-fda-510k.jpg K210909 - easyEndo Lite Linear Cutting Stapler and Loading Unit for Single Use K210909 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ezisurg Medical Co., Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k210948/ 2021-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k210948-omnilux-clear-fda-510k.jpg K210948 - Omnilux CLEAR K210948 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Globalmed Technologies. Cleared Jun 2021. https://www.510kdatabase.net/k210959/ 2021-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k210959-rs85-diagnostic-ultrasound-system-rs80-fda-510k.jpg K210959 - RS85 Diagnostic Ultrasound System, RS80 EVO Diagnostic Ultrasound System K210959 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Medison Co., Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k211191/ 2021-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k211191-virtual-c-drf-digital-imaging-system-fda-510k.jpg K211191 - Virtual C DRF Digital Imaging System K211191 is a FDA 510(k) cleared radiology medical device. Manufacturer: Portavision Medical, LLC. Cleared Jun 2021. https://www.510kdatabase.net/k211259/ 2021-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k211259-renamel-bulkfill-fda-510k.jpg K211259 - Renamel Bulkfill K211259 is a FDA 510(k) cleared dental medical device. Manufacturer: Cosmedent, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k211297/ 2021-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k211297-smartrelease-endoscopic-soft-tissue-fda-510k.jpg K211297 - SMARTRELEASE Endoscopic Soft Tissue Release System K211297 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Microaire Surgical Instruments. Cleared Jun 2021. https://www.510kdatabase.net/k211306/ 2021-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k211306-labyrinth-fda-510k.jpg K211306 - LABYRINTH K211306 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zavation Medical Products, LLC. Cleared Jun 2021. https://www.510kdatabase.net/k211623/ 2021-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k211623-thd-procto-software-system-fda-510k.jpg K211623 - THD Procto Software System K211623 is a FDA 510(k) cleared radiology medical device. Manufacturer: Thd Spa. Cleared Jun 2021. https://www.510kdatabase.net/k201806/ 2021-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k201806-reprocessed-pentaray-nav-eco-high-fda-510k.jpg K201806 - Reprocessed PentaRay Nav eco High-Density Mapping Catheter K201806 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sterilmed Inc. (Johnson and Johnson). Cleared Jun 2021. https://www.510kdatabase.net/k203456/ 2021-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k203456-straumann-cares-m-series-cadcam-system-fda-510k.jpg K203456 - Straumann CARES M-Series CAD/CAM System K203456 is a FDA 510(k) cleared dental medical device. Manufacturer: Institut Straumann AG. Cleared Jun 2021. https://www.510kdatabase.net/k203725/ 2021-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k203725-sin-dental-implant-system-fda-510k.jpg K203725 - S.I.N. Dental Implant System K203725 is a FDA 510(k) cleared dental medical device. Manufacturer: S.I.N. ? Sistema DE Implante Nacional S.A.. Cleared Jun 2021. https://www.510kdatabase.net/k210258/ 2021-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k210258-novofine-fda-510k.jpg K210258 - NovoFine K210258 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Novo Nordisk, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k211045/ 2021-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k211045-synthetic-vinyl-examination-gloves-fda-510k.jpg K211045 - Synthetic Vinyl Examination Gloves K211045 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Huayuan Medical Technology Co., Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k211408/ 2021-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k211408-cervalign-anterior-cervical-plate-system-fda-510k.jpg K211408 - CervAlign® Anterior Cervical Plate System K211408 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Pioneer Surgical Technology, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k211595/ 2021-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k211595-da-vinci-sp-surgical-system-sp1098-fda-510k.jpg K211595 - da Vinci SP Surgical System (SP1098) K211595 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k211596/ 2021-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k211596-cd-horizon-spinal-system-fda-510k.jpg K211596 - CD Horizon Spinal System K211596 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic. Cleared Jun 2021. https://www.510kdatabase.net/k211606/ 2021-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k211606-mariner-deformity-system-fda-510k.jpg K211606 - Mariner Deformity System K211606 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared Jun 2021. https://www.510kdatabase.net/k211695/ 2021-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k211695-valkyrie-thoracic-fixation-system-fda-510k.jpg K211695 - Valkyrie Thoracic Fixation System K211695 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices. Cleared Jun 2021. https://www.510kdatabase.net/k201935/ 2021-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k201935-air-pressure-therapy-system-fda-510k.jpg K201935 - Air Pressure Therapy System K201935 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Xiamen Weiyou Intelligent Technology Co., Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k202991/ 2021-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k202991-fotona-xpulse-pro-laser-platform-fda-510k.jpg K202991 - Fotona XPulse Pro Laser Platform K202991 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Fotona D.O.O.. Cleared Jun 2021. https://www.510kdatabase.net/k203019/ 2021-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k203019-lf900-fda-510k.jpg K203019 - LF900 K203019 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Daesung Maref Co., Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k203720/ 2021-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k203720-micromate-fda-510k.jpg K203720 - MICROMATE K203720 is a FDA 510(k) cleared radiology medical device. Manufacturer: Isys Medizintechnik GmbH. Cleared Jun 2021. https://www.510kdatabase.net/k210161/ 2021-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k210161-anyone-onestage-implant-system-fda-510k.jpg K210161 - AnyOne Onestage Implant System K210161 is a FDA 510(k) cleared dental medical device. Manufacturer: Megagen Implant Co., Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k210840/ 2021-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k210840-disposable-surgical-mask-fda-510k.jpg K210840 - Disposable Surgical Mask K210840 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Safeway Industry Healthcare.. Cleared Jun 2021. https://www.510kdatabase.net/k210881/ 2021-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k210881-m-series-phototherapy-equipment-fda-510k.jpg K210881 - M Series Phototherapy Equipment K210881 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Daavlin Distributing Co.. Cleared Jun 2021. https://www.510kdatabase.net/k210882/ 2021-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k210882-moleculight-ix-fda-510k.jpg K210882 - MolecuLight I:X K210882 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Moleculight, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k211215/ 2021-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k211215-senobright-hd-fda-510k.jpg K211215 - SenoBright HD K211215 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Jun 2021. https://www.510kdatabase.net/k211272/ 2021-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k211272-icoone-laser-med-also-referred-to-as-fda-510k.jpg K211272 - ICOONE Laser Med (also referred to as ICOONE Medical laser) K211272 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: I-Tech Industries Srl. Cleared Jun 2021. https://www.510kdatabase.net/k193301/ 2021-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k193301-codiagnostix-fda-510k.jpg K193301 - coDiagnostiX K193301 is a FDA 510(k) cleared dental medical device. Manufacturer: Dental Wings GmbH. Cleared Jun 2021. https://www.510kdatabase.net/k201737/ 2021-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k201737-posterior-spinal-fixation-system-fda-510k.jpg K201737 - Posterior Spinal Fixation System K201737 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Shanghai Reach Medical Instrument Co, Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k202085/ 2021-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k202085-biodegradable-powder-free-neoprene-fda-510k.jpg K202085 - Biodegradable Powder Free Neoprene Examination Glove, Low Dermatitis Potential Claim, Green K202085 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shen Wei (Usa), Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k202855/ 2021-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k202855-orthodontic-facemask-fda-510k.jpg K202855 - Orthodontic Facemask K202855 is a FDA 510(k) cleared dental medical device. Manufacturer: Ita.O Italian Orthodontic System S.R.L.. Cleared Jun 2021. https://www.510kdatabase.net/k202902/ 2021-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k202902-2430mca-with-xmaru-w-fda-510k.jpg K202902 - 2430MCA with Xmaru W K202902 is a FDA 510(k) cleared radiology medical device. Manufacturer: Rayence Co., Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k210375/ 2021-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k210375-powder-free-blue-nitrile-examination-fda-510k.jpg K210375 - Powder Free Blue Nitrile Examination Glove K210375 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Duramitt Sdn Bhd. Cleared Jun 2021. https://www.510kdatabase.net/k210457/ 2021-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k210457-7d-registration-frame-7d-flex-iliac-fda-510k.jpg K210457 - 7D Registration Frame, 7D Flex Iliac Pin Connector, 7D Pin Guide Block, 7D 3.2 mm Steinmann Pin, 7D Iliac Crest Pin Chuck & Key K210457 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 7D Surgical, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k210855/ 2021-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k210855-straumann-blx-implant-system-fda-510k.jpg K210855 - Straumann BLX Implant System K210855 is a FDA 510(k) cleared dental medical device. Manufacturer: Institut Straumann AG. Cleared Jun 2021. https://www.510kdatabase.net/k210866/ 2021-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k210866-steri-dot-process-indicator-fda-510k.jpg K210866 - Steri-Dot Process Indicator K210866 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Propper Manufacturing Co., Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k210899/ 2021-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k210899-link-embrace-shoulder-system-fda-510k.jpg K210899 - LINK Embrace Shoulder System- Anatomical Configuration K210899 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Waldemar Link GmbH & Co. KG. Cleared Jun 2021. https://www.510kdatabase.net/k211250/ 2021-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k211250-visionport-system-fda-510k.jpg K211250 - VisionPort System K211250 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: New View Surgical, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k202893/ 2021-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k202893-transcutaneous-electrical-nerve-fda-510k.jpg K202893 - Transcutaneous Electrical Nerve Stimulator K202893 is a FDA 510(k) cleared neurology medical device. Manufacturer: Wuxi Jiajian Medical Instrument Co., Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k202964/ 2021-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k202964-ibed-wireless-with-ibed-mobile-fda-510k.jpg K202964 - iBed Wireless with iBed Mobile K202964 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Stryker Corporation. Cleared Jun 2021. https://www.510kdatabase.net/k210220/ 2021-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k210220-kontact-dental-implant-system-fda-510k.jpg K210220 - Kontact Dental Implant System K210220 is a FDA 510(k) cleared dental medical device. Manufacturer: Biotech Dental, Sas. Cleared Jun 2021. https://www.510kdatabase.net/k210430/ 2021-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k210430-intravascular-extension-set-fda-510k.jpg K210430 - Intravascular Extension Set K210430 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corporation. Cleared Jun 2021. https://www.510kdatabase.net/k210495/ 2021-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k210495-port-access-system-fda-510k.jpg K210495 - Port Access System K210495 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Surgical Innovations Limited. Cleared Jun 2021. https://www.510kdatabase.net/k201314/ 2021-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k201314-restor3d-utility-wedge-fda-510k.jpg K201314 - Restor3d Utility Wedge K201314 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Restor3D, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k201744/ 2021-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k201744-su2ura-approximation-device-fda-510k.jpg K201744 - Su2ura Approximation Device K201744 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Anchora Medical, Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k202440/ 2021-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k202440-infrared-thermometer-fda-510k.jpg K202440 - Infrared Thermometer K202440 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen Sonida Digital Technology Co., Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k202806/ 2021-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k202806-fix2lock-biocomposite-medial-fda-510k.jpg K202806 - Fix2Lock (Biocomposite medial, Biocomposite lateral, Biocombi Self Punching) K202806 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonic Co., Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k203514/ 2021-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k203514-precise-position-fda-510k.jpg K203514 - Precise Position K203514 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Healthcare (Suzhou) Co., Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k210281/ 2021-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k210281-fist-assist-devices-model-fa-1-fda-510k.jpg K210281 - Fist Assist Devices Model FA-1 K210281 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fist Assist Devices, LLC. Cleared Jun 2021. https://www.510kdatabase.net/k210364/ 2021-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k210364-migraine-tens-digital-pain-reliever-fda-510k.jpg K210364 - Migraine Tens Digital Pain Reliever K210364 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Dongdixin Technology Co., Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k210700/ 2021-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k210700-navinetics-d1-stereotactic-system-fda-510k.jpg K210700 - NaviNetics D1 Stereotactic System K210700 is a FDA 510(k) cleared neurology medical device. Manufacturer: Navinetics, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k210883/ 2021-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k210883-ascope-4-broncho-regular-sampler-set-fda-510k.jpg K210883 - aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8 K210883 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Ambu A/S. Cleared Jun 2021. https://www.510kdatabase.net/k210886/ 2021-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k210886-mis-lance-conical-connection-dental-fda-510k.jpg K210886 - MIS Lance+ Conical Connection Dental Implant System K210886 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona. Cleared Jun 2021. https://www.510kdatabase.net/k211535/ 2021-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k211535-sonata-transcervical-fibroid-ablation-fda-510k.jpg K211535 - Sonata Transcervical Fibroid Ablation System 2.2 K211535 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Gynesonics, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k193604/ 2021-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k193604-aptiva-celiac-disease-iga-reagent-fda-510k.jpg K193604 - Aptiva Celiac Disease IgA Reagent K193604 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k202718/ 2021-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k202718-qmenta-care-platform-family-fda-510k.jpg K202718 - Qmenta Care Platform Family K202718 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mint Labs, Inc., D/B/A. Qmenta. Cleared Jun 2021. https://www.510kdatabase.net/k203200/ 2021-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k203200-disposable-medical-surgical-face-mask-fda-510k.jpg K203200 - Disposable Medical Surgical Face Mask K203200 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guangdong Haiou Medical Apparatus Co., Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k210034/ 2021-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k210034-ensosleep-fda-510k.jpg K210034 - EnsoSleep K210034 is a FDA 510(k) cleared neurology medical device. Manufacturer: Ensodata, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k210694/ 2021-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k210694-silent-nite-sleep-appliance-with-the-fda-510k.jpg K210694 - Silent Nite Sleep Appliance with the Glidewell Hinge K210694 is a FDA 510(k) cleared dental medical device. Manufacturer: Prismatik Dentalcraft, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k210920/ 2021-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k210920-ibot-personal-mobility-device-ibot-pmd-fda-510k.jpg K210920 - iBOT Personal Mobility Device (iBOT PMD) K210920 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Mobius Mobility. Cleared Jun 2021. https://www.510kdatabase.net/k211044/ 2021-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k211044-sublime-radial-access-018-rx-fda-510k.jpg K211044 - Sublime Radial Access 018 RX Dilatation Catheter K211044 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Creagh Medical Ltd. (A Wholly Owned Subsidiary of Surmodics,. Cleared Jun 2021. https://www.510kdatabase.net/k211310/ 2021-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k211310-amadex-nitrile-powder-free-examination-fda-510k.jpg K211310 - AMADEX - Nitrile Powder Free Examination Gloves Non-Sterile (Blue, Black, Orange) K211310 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Megine Industries Sdn Bhd. Cleared Jun 2021. https://www.510kdatabase.net/k211336/ 2021-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k211336-disposable-vinyl-examination-glove-fda-510k.jpg K211336 - Disposable Vinyl Examination Glove K211336 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Inner Mongolia Cureguard Medical Materials Co., Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k203244/ 2021-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k203244-cellchek-20-rc-fda-510k.jpg K203244 - CellChek 20 rc K203244 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Konan Medical, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k210595/ 2021-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k210595-spira-t-oblique-posterior-lumbar-fda-510k.jpg K210595 - SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar Spacers K210595 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Camber Spine Technologies, LLC. Cleared Jun 2021. https://www.510kdatabase.net/k211520/ 2021-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k211520-amerishield-surgical-mask-fda-510k.jpg K211520 - Amerishield Surgical Mask K211520 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Premiumestore, LLC. Cleared Jun 2021. https://www.510kdatabase.net/k200466/ 2021-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k200466-manual-wheelchair-model-w28-fda-510k.jpg K200466 - Manual Wheelchair (Model W28) K200466 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Jiangsu Jumao X-Care Medical Equipment Co., Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k201397/ 2021-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k201397-ultrasonic-mesh-nebulizer-fda-510k.jpg K201397 - Ultrasonic Mesh Nebulizer K201397 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Ivankaca Technology Co., Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k202813/ 2021-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k202813-uro-touch-9-french-probe-fda-510k.jpg K202813 - URO-TOUCH 9 French Probe K202813 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Northgate Technologies, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k203400/ 2021-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k203400-corrugated-tube-with-mouthpiece-fda-510k.jpg K203400 - Corrugated tube with mouthpiece accessory K203400 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Trudell Medical International. Cleared Jun 2021. https://www.510kdatabase.net/k203850/ 2021-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k203850-cats-d-tonometer-prism-fda-510k.jpg K203850 - CATS®-D Tonometer Prism K203850 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Cats Tonometer, LLC. Cleared Jun 2021. https://www.510kdatabase.net/k210518/ 2021-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k210518-surgical-face-mask-fda-510k.jpg K210518 - Surgical Face Mask K210518 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shandong Haidike Medical Products Co., Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k210814/ 2021-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k210814-coconu-water-based-personal-lubricant-fda-510k.jpg K210814 - Coconu Water Based Personal Lubricant K210814 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Coconu, LLC. Cleared Jun 2021. https://www.510kdatabase.net/k211101/ 2021-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k211101-e-temp-fda-510k.jpg K211101 - E-Temp K211101 is a FDA 510(k) cleared dental medical device. Manufacturer: Envisiontec GmbH. Cleared Jun 2021. https://www.510kdatabase.net/k211136/ 2021-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k211136-vitek-2-ast-gram-negative-fda-510k.jpg K211136 - VITEK 2 AST-Gram Negative Imipenem/Relebactam (<0.25/4 - >16/4 ug/ML) K211136 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k211518/ 2021-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k211518-24mm-x-130cm-phoenix-deflecting-fda-510k.jpg K211518 - 2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy System K211518 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Volcano Atheromed, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k210401/ 2021-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k210401-microflex-nitrile-patient-examination-fda-510k.jpg K210401 - Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Green Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate, Microflex Nitrile Patient Examination Gloves Black Colored Tested for Use with Chemotherapy Drugs and Fentanyl Citrate K210401 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ansell Healthcare Products, LLC. Cleared Jun 2021. https://www.510kdatabase.net/k202714/ 2021-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k202714-medical-face-mask-fda-510k.jpg K202714 - Medical Face Mask K202714 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Chongqing Chaoke Industry Development Co., Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k202766/ 2021-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k202766-eos-air-cleaner-fda-510k.jpg K202766 - EOS Air Cleaner K202766 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guangzhou Ajax Medical Equipment Co., Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k203030/ 2021-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k203030-powder-free-nitrile-surgical-glove-fda-510k.jpg K203030 - POWDER FREE NITRILE SURGICAL GLOVE, STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS K203030 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wrp Asia Pacific Sdn. Bhd.. Cleared Jun 2021. https://www.510kdatabase.net/k203215/ 2021-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k203215-radius-t-wearable-thermometer-fda-510k.jpg K203215 - Radius T wearable thermometer K203215 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Masimo Corporation. Cleared Jun 2021. https://www.510kdatabase.net/k203569/ 2021-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k203569-gold-tapered-weight-eyelid-implants-fda-510k.jpg K203569 - Gold Tapered Weight Eyelid Implants, Platinum Tapered Weight Eyelid Implants K203569 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Fci (France Chirurgie Instrumentation) Sas. Cleared Jun 2021. https://www.510kdatabase.net/k203732/ 2021-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k203732-surgical-face-mask-fda-510k.jpg K203732 - Surgical Face Mask K203732 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zhuhai Gaoge Medical Technology Co., Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k203818/ 2021-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k203818-replens-long-lasting-vaginal-moisturizer-fda-510k.jpg K203818 - Replens Long-Lasting Vaginal Moisturizer K203818 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Church & Dwight Co., Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k210021/ 2021-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k210021-axon-therapy-fda-510k.jpg K210021 - Axon Therapy K210021 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Neuralace Medical, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k210484/ 2021-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k210484-linq-ii-insertable-cardiac-monitor-fda-510k.jpg K210484 - LINQ II Insertable Cardiac Monitor, Zelda AI ECG Classification System K210484 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k210500/ 2021-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k210500-elekta-synergy-elekta-harmony-elekta-fda-510k.jpg K210500 - Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD K210500 is a FDA 510(k) cleared radiology medical device. Manufacturer: Elekta Limited. Cleared Jun 2021. https://www.510kdatabase.net/k210504/ 2021-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k210504-panavia-veneer-lc-fda-510k.jpg K210504 - PANAVIA Veneer LC K210504 is a FDA 510(k) cleared dental medical device. Manufacturer: Kuraray Noritake Dental, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k210756/ 2021-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k210756-neck-care-therapy-model-ast-905a-ast-fda-510k.jpg K210756 - Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H K210756 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Osto Technology Company Limited. Cleared Jun 2021. https://www.510kdatabase.net/k201493/ 2021-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k201493-spirometer-fda-510k.jpg K201493 - Spirometer K201493 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Mehow Innovative, Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k203629/ 2021-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k203629-idx-dr-fda-510k.jpg K203629 - IDx-DR K203629 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Digital Diagnostics, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k203756/ 2021-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k203756-disposable-surgical-mask-fda-510k.jpg K203756 - Disposable Surgical Mask K203756 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Lucky Textile Industrial(Wuxi) Co., Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k203779/ 2021-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k203779-symmetric-total-knee-system-fda-510k.jpg K203779 - Symmetric Total Knee System K203779 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Signal Medical Corporation. Cleared Jun 2021. https://www.510kdatabase.net/k210015/ 2021-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k210015-surgical-face-mask-fda-510k.jpg K210015 - Surgical Face Mask K210015 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sample King Manufacturing, Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k210335/ 2021-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k210335-blood-administration-set-fda-510k.jpg K210335 - Blood Administration Set K210335 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corporation. Cleared Jun 2021. https://www.510kdatabase.net/k210416/ 2021-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k210416-m9m9cvm9tm8-elitem10m10cvcrius-fda-510k.jpg K210416 - M9/M9CV/M9T/M8 Elite/M10/M10CV/Crius M10/M11/M11CV/Crius M11/Operus M11/M9 Premium Diagnostic Ultrasound System K210416 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k210522/ 2021-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k210522-disposable-vinyl-examination-gloves-fda-510k.jpg K210522 - Disposable Vinyl Examination Gloves K210522 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shandong Shengshixincheng Medical Science & Technology Co.,. Cleared Jun 2021. https://www.510kdatabase.net/k210699/ 2021-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k210699-resona-i9-resona-i9-exp-resona-i9s-fda-510k.jpg K210699 - Resona I9, Resona I9 Exp, Resona I9S, Resona I9T, Resona I9 Easi, Resona I9 Nasa, Resona IV, Imagyn I9, Imagyn I9S, Imagyn I9 Easi, Nuewa I9, Nuewa I9S, Nuewa I9T, Nuewa I9 Exp, Nuewa I9 Easi, Anesus I9, Anesus I9 Easi, Eagus I9 Diagnostic Ultrasound System K210699 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k210767/ 2021-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k210767-surgical-masks-modelfe-1-fda-510k.jpg K210767 - Surgical Masks, Model:FE-1 K210767 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hunan Triplex Precision Medical Devices Co., Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k210972/ 2021-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k210972-h2o-warming-personal-lubricant-h2o-fda-510k.jpg K210972 - H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tango for You, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Warming, #LubeLife Sensations Pleasure Kit for Two K210972 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: CC Wellness, LLC. Cleared Jun 2021. https://www.510kdatabase.net/k210986/ 2021-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k210986-h2o-cooling-personal-lubricant-h2o-fda-510k.jpg K210986 - H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, #LubeLife Sensations Cooling, #LubeLife Sensations Pleasure Kit for Two, JO 2 To Tango for Me, JO 2 To Tango Couples Pleasure Kit K210986 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: CC Wellness, LLC. Cleared Jun 2021. https://www.510kdatabase.net/k211061/ 2021-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k211061-bashir-endovascular-catheter-ref-7201-fda-510k.jpg K211061 - BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref. 7210), BASHIR Plus 20 Endovascular Catheter (Ref. 7220), BASHIR Plus 30 Endovascular Catheter (Ref. 7230), BASHIR Plus 40 Endovascular Catheter (Ref. 7240) K211061 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Thrombolex, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k211459/ 2021-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k211459-syngovia-mi-workflows-scenium-syngo-mbf-fda-510k.jpg K211459 - syngo.via MI WorkFlows, Scenium, syngo MBF K211459 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k211469/ 2021-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k211469-callaly-tampliner-fda-510k.jpg K211469 - Callaly Tampliner K211469 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Calla Lily Personal Care, Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k211590/ 2021-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k211590-fiducial-marker-fda-510k.jpg K211590 - Fiducial Marker K211590 is a FDA 510(k) cleared radiology medical device. Manufacturer: Carbon Medical Technologies, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k203815/ 2021-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k203815-eleos-limb-salvage-system-with-biogrip-fda-510k.jpg K203815 - ELEOS Limb Salvage System with BioGrip K203815 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Onkos Surgical. Cleared Jun 2021. https://www.510kdatabase.net/k210591/ 2021-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k210591-palm-bladder-scanner-pbsv71-fda-510k.jpg K210591 - Palm Bladder Scanner - PBSV7.1 K210591 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mianyang Meike Electronic Equipment Co., Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k211216/ 2021-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k211216-vivid-s60n-vivid-s70n-fda-510k.jpg K211216 - Vivid S60N / Vivid S70N K211216 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared Jun 2021. https://www.510kdatabase.net/k211441/ 2021-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k211441-navigated-anterolateral-disc-prep-fda-510k.jpg K211441 - Navigated Anterolateral Disc Prep Instruments K211441 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k211490/ 2021-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k211490-pi-drive-2-motor-model-number-5407-150-fda-510k.jpg K211490 - Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000 K211490 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Stryker Corporation. Cleared Jun 2021. https://www.510kdatabase.net/k202126/ 2021-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k202126-disposable-surgical-mask-fda-510k.jpg K202126 - Disposable Surgical Mask K202126 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen Peninsula Medical Co., Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k210458/ 2021-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k210458-optis-mobile-next-imaging-system-optis-fda-510k.jpg K210458 - OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System K210458 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared Jun 2021. https://www.510kdatabase.net/k211062/ 2021-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k211062-medical-face-mask-fda-510k.jpg K211062 - Medical Face Mask K211062 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ammex-Weida (Hubei) Health and Safety Products Co., Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k211476/ 2021-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k211476-zoom-71-reperfusion-catheter-fda-510k.jpg K211476 - ZOOM 71 Reperfusion Catheter K211476 is a FDA 510(k) cleared neurology medical device. Manufacturer: Imperative Care, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k193383/ 2021-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k193383-snugkap-fda-510k.jpg K193383 - SnugKap K193383 is a FDA 510(k) cleared neurology medical device. Manufacturer: Headstart, Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k201914/ 2021-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k201914-hrvwatch-mini-wrist-monitor-fda-510k.jpg K201914 - HRVWatch-Mini Wrist Monitor K201914 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Taiwan Scientific Corporation. Cleared Jun 2021. https://www.510kdatabase.net/k202580/ 2021-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k202580-disposable-surgical-mask-fda-510k.jpg K202580 - Disposable Surgical Mask K202580 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Qingdao Likangyuan Medical Device Co., Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k202663/ 2021-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k202663-suture-wing-fda-510k.jpg K202663 - Suture Wing K202663 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonic Co., Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k203802/ 2021-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k203802-x-pac-expandable-lumbar-cage-system-fda-510k.jpg K203802 - X-Pac Expandable Lumbar Cage System K203802 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Expanding Innovations, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k210050/ 2021-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k210050-augmented-vaultlock-glenoid-fda-510k.jpg K210050 - Augmented VaultLock Glenoid K210050 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k210372/ 2021-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k210372-disposable-surgical-mask-fda-510k.jpg K210372 - Disposable Surgical Mask K210372 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Dongguan Shin YI Healthcare Products Factory. Cleared Jun 2021. https://www.510kdatabase.net/k210433/ 2021-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k210433-surgical-face-mask-ear-loops-and-tie-on-fda-510k.jpg K210433 - Surgical Face Mask (Ear loops and Tie-on) K210433 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wuhan Dymex Healthcare Co., Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k210641/ 2021-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k210641-disposable-medical-mask-fda-510k.jpg K210641 - Disposable Medical Mask K210641 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Tuosheng Protective Products (Ningbo) Co., Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k200694/ 2021-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k200694-perfect-ems-fda-510k.jpg K200694 - Perfect EMS K200694 is a FDA 510(k) cleared neurology medical device. Manufacturer: Tenscare, Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k201309/ 2021-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k201309-ect-cotton-bite-block-size-large-ect-fda-510k.jpg K201309 - ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium K201309 is a FDA 510(k) cleared neurology medical device. Manufacturer: Mecta Corporation. Cleared Jun 2021. https://www.510kdatabase.net/k201842/ 2021-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k201842-trubase-s-fda-510k.jpg K201842 - TruBase S K201842 is a FDA 510(k) cleared dental medical device. Manufacturer: Truabutment, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k202217/ 2021-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k202217-kendall-npwt-incision-management-device-fda-510k.jpg K202217 - Kendall NPWT Incision Management Device K202217 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cardinalhealth. Cleared Jun 2021. https://www.510kdatabase.net/k202596/ 2021-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k202596-insulia-diabetes-management-companion-fda-510k.jpg K202596 - Insulia Diabetes Management Companion K202596 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Voluntis Sa.. Cleared Jun 2021. https://www.510kdatabase.net/k202763/ 2021-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k202763-fix2lock-peek-self-punching-fda-510k.jpg K202763 - Fix2Lock (PEEK Self Punching) K202763 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonic Co., Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k202828/ 2021-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k202828-surgical-green-laser-system-fda-510k.jpg K202828 - Surgical Green Laser System K202828 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Realton (Suzhou) Medical Technology Co., Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k203388/ 2021-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k203388-disposable-medical-mask-fda-510k.jpg K203388 - Disposable medical mask K203388 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Everwin Toys (Dongguan)., Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k203626/ 2021-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k203626-surestrip-vitrification-straw-surelock-fda-510k.jpg K203626 - SureStrip Vitrification Straw, SureLock Vitrification Straw K203626 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Allwin Medical Devices, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k203704/ 2021-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k203704-surgical-face-mask-fda-510k.jpg K203704 - Surgical face mask K203704 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Juntech(Jiaxing)Healthcare Materials Co,.Ltd. Cleared Jun 2021. https://www.510kdatabase.net/k210014/ 2021-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k210014-infrared-forehead-thermometer-model-fda-510k.jpg K210014 - Infrared Forehead Thermometer (Model: T80, T81, T82, T83, T84, T85) K210014 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guandong Genial Technology Co., Limited. Cleared Jun 2021. https://www.510kdatabase.net/k210080/ 2021-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k210080-dentis-s-clean-s-line-mini-fda-510k.jpg K210080 - Dentis s-Clean s-Line Mini K210080 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentis Co., Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k210613/ 2021-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k210613-hit-clear-aligner-fda-510k.jpg K210613 - HIT Clear Aligner K210613 is a FDA 510(k) cleared dental medical device. Manufacturer: Cdb Corporation. Cleared Jun 2021. https://www.510kdatabase.net/k211028/ 2021-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k211028-nitrile-patient-examination-gloves-fda-510k.jpg K211028 - Nitrile Patient Examination Gloves K211028 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Huayuan Medical Technology(Shangqiu) Co., Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k211081/ 2021-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k211081-alphavac-multipurpose-mechanical-fda-510k.jpg K211081 - AlphaVac Multipurpose Mechanical Aspiration (MMA) System K211081 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: AngioDynamics, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k211108/ 2021-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k211108-prudent-1717-prudent-1417-prudent-1212-fda-510k.jpg K211108 - Prudent 1717, Prudent 1417, Prudent 1212 K211108 is a FDA 510(k) cleared radiology medical device. Manufacturer: Pixxgen Corporation. Cleared Jun 2021. https://www.510kdatabase.net/k211303/ 2021-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k211303-avon-patello-femoral-joint-prosthesis-fda-510k.jpg K211303 - Avon Patello-femoral Joint Prosthesis K211303 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp., Dba Stryker Orthopaedics. Cleared Jun 2021. https://www.510kdatabase.net/k211410/ 2021-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k211410-glidepath-13f-long-term-hemodialysis-fda-510k.jpg K211410 - GlidePath 13F Long-Term Hemodialysis Catheter K211410 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Bard Peripheral Vascular, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k211473/ 2021-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k211473-micro-c-medical-imaging-system-m01-fda-510k.jpg K211473 - Micro C Medical Imaging System, M01 K211473 is a FDA 510(k) cleared radiology medical device. Manufacturer: Oxos Medical, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k200722/ 2021-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k200722-pca-c1-series-patient-cable-fda-510k.jpg K200722 - PCA-C1 series Patient Cable K200722 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: QT Medical, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k202128/ 2021-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k202128-allmed-surgical-face-masks-ear-loops-fda-510k.jpg K202128 - Allmed Surgical Face Masks (Ear loops) K202128 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Allmed Medical Products Co., Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k210604/ 2021-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k210604-intellihab-system-fda-510k.jpg K210604 - Intellihab System K210604 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Cymedica Orthopedics, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k210627/ 2021-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k210627-breezeway-ii-fda-510k.jpg K210627 - Breezeway II K210627 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Oscor, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k211323/ 2021-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k211323-astra-spine-system-fda-510k.jpg K211323 - ASTRA Spine System K211323 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinecraft, LLC. Cleared Jun 2021. https://www.510kdatabase.net/k211401/ 2021-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k211401-soltive-laser-system-soltive-pro-fda-510k.jpg K211401 - SOLTIVE Laser System (SOLTIVE Pro SuperPulsed Laser, SOLTIVE Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories) K211401 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Gyrus Acmi, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k200891/ 2021-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k200891-bd-intima-ii-closed-iv-catheter-system-fda-510k.jpg K200891 - BD Intima II Closed IV Catheter System, BD Intima II PLUS Closed IV Catheter System K200891 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson and Company. Cleared Jun 2021. https://www.510kdatabase.net/k203190/ 2021-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k203190-surgical-face-mask-fda-510k.jpg K203190 - Surgical Face Mask K203190 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Rfx+Care Manufactoring Co., Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k203229/ 2021-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k203229-natrelle-inspira-single-use-sizers-for-fda-510k.jpg K203229 - NATRELLE INSPIRA Single Use Sizers for Gel Implants K203229 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Allergan. Cleared Jun 2021. https://www.510kdatabase.net/k210150/ 2021-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k210150-disposable-medical-mask-fda-510k.jpg K210150 - Disposable Medical mask K210150 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hubei Wanli Protective Products Co., Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k210404/ 2021-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k210404-transpara-170-fda-510k.jpg K210404 - Transpara 1.7.0 K210404 is a FDA 510(k) cleared radiology medical device. Manufacturer: Screenpoint Medical B.V.. Cleared Jun 2021. https://www.510kdatabase.net/k210429/ 2021-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k210429-disposable-surgical-face-mask-fda-510k.jpg K210429 - Disposable Surgical Face Mask K210429 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangxi Heying Pharmaceutical Co., Ltd.. Cleared Jun 2021. https://www.510kdatabase.net/k210583/ 2021-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k210583-seaspine-waveform-a-interbody-system-fda-510k.jpg K210583 - SeaSpine WaveForm™ A Interbody System K210583 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared Jun 2021. https://www.510kdatabase.net/k210652/ 2021-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k210652-6ms-invisible-aligner-fda-510k.jpg K210652 - 6MS Invisible Aligner K210652 is a FDA 510(k) cleared dental medical device. Manufacturer: Sms Opco, LLC. Cleared Jun 2021. https://www.510kdatabase.net/k211051/ 2021-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k211051-depuy-synthes-27mm-straight-and-27mm-fda-510k.jpg K211051 - DePuy Synthes 2.7mm Straight and 2.7mm Adaption Plates (Modular Mini Fragment LCP System) K211051 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Synthes. Cleared Jun 2021. https://www.510kdatabase.net/k211372/ 2021-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k211372-mahana-parallel-digital-cognitive-fda-510k.jpg K211372 - Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS) K211372 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Mahana Therapeutics, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k211440/ 2021-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k211440-asm-301-level-3-surgical-mask-fda-510k.jpg K211440 - ASM-301 Level 3 Surgical Mask K211440 is a FDA 510(k) cleared general hospital medical device. Manufacturer: American Surgical Mask Company, LLC. Cleared Jun 2021. https://www.510kdatabase.net/den200069/ 2021-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/den200069-cognoa-asd-diagnosis-aid-fda-510k.jpg DEN200069 - Cognoa ASD Diagnosis Aid DEN200069 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cognoa, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k200942/ 2021-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k200942-well-life-garment-electrodes-gm-series-fda-510k.jpg K200942 - Well-Life Garment Electrodes (GM Series) K200942 is a FDA 510(k) cleared neurology medical device. Manufacturer: Well-Life Healthcare Limited. Cleared Jun 2021. https://www.510kdatabase.net/k210994/ 2021-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k210994-arthrex-beveled-ft-screws-fda-510k.jpg K210994 - Arthrex Beveled FT Screws K210994 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jun 2021. https://www.510kdatabase.net/k200607/ 2021-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k200607-link-mobilelink-acetabular-cup-system-fda-510k.jpg K200607 - LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters K200607 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Waldemar Link GmbH & Co. KG. Cleared May 2021. https://www.510kdatabase.net/k202932/ 2021-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k202932-abt12-multi-purpose-solution-fda-510k.jpg K202932 - ABT12 multi-purpose solution K202932 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Bausch & Lomb, Incorporated. Cleared May 2021. https://www.510kdatabase.net/k203687/ 2021-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k203687-hemosphere-advanced-monitor-hemosphere-fda-510k.jpg K203687 - HemoSphere Advanced Monitor, HemoSphere ClearSight Module, Acumen Hypotension Prediction Index K203687 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared May 2021. https://www.510kdatabase.net/k210025/ 2021-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k210025-invu-by-nuvo-fda-510k.jpg K210025 - INVU by Nuvo K210025 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Nuvo- Group , Ltd.. Cleared May 2021. https://www.510kdatabase.net/k210188/ 2021-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k210188-coracross-fda-510k.jpg K210188 - coraCross K210188 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Reflow Medical. Cleared May 2021. https://www.510kdatabase.net/k210289/ 2021-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k210289-infant-phototherapy-equipment-fda-510k.jpg K210289 - Infant Phototherapy Equipment K210289 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bistos Co., Ltd.. Cleared May 2021. https://www.510kdatabase.net/k210536/ 2021-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k210536-irrisept-antimicrobial-wound-lavage-fda-510k.jpg K210536 - Irrisept Antimicrobial Wound Lavage K210536 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Irrimax Corporation. Cleared May 2021. https://www.510kdatabase.net/k210917/ 2021-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k210917-single-use-injection-needle-fda-510k.jpg K210917 - Single Use Injection Needle K210917 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Anrei Medical (Hangzhou) Co., Ltd.. Cleared May 2021. https://www.510kdatabase.net/k211261/ 2021-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k211261-axis-charcot-fixation-system-fda-510k.jpg K211261 - Axis Charcot Fixation System K211261 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Extremity Medical, LLC. Cleared May 2021. https://www.510kdatabase.net/k211301/ 2021-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k211301-pathfinder-endoscope-overtube-fda-510k.jpg K211301 - Pathfinder Endoscope Overtube K211301 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Neptune Medical, Inc.. Cleared May 2021. https://www.510kdatabase.net/k211304/ 2021-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k211304-linq-ii-insertable-cardiac-monitor-fda-510k.jpg K211304 - LINQ II Insertable Cardiac Monitor K211304 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared May 2021. https://www.510kdatabase.net/k211311/ 2021-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k211311-atricure-isolator-synergy-surgical-fda-510k.jpg K211311 - AtriCure Isolator® Synergy™ Surgical Ablation System K211311 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: AtriCure, Inc.. Cleared May 2021. https://www.510kdatabase.net/k211344/ 2021-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k211344-micrusframe-deltafill-deltaxsft-galaxy-fda-510k.jpg K211344 - MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini Microcoil Delivery Systems K211344 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medos International SARL. Cleared May 2021. https://www.510kdatabase.net/k200704/ 2021-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k200704-zedview-fda-510k.jpg K200704 - ZedView K200704 is a FDA 510(k) cleared radiology medical device. Manufacturer: Lexi Co., Ltd.. Cleared May 2021. https://www.510kdatabase.net/k201639/ 2021-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k201639-disposable-circular-staple-disposable-fda-510k.jpg K201639 - Disposable Circular Staple, Disposable Hemorrhoidal Stapler, Disposable Linear Stapler and Reloads, Disposable Linear Cutter Stapler and Reloads, Disposable Endoscopic Linear Cutter Stapler and Reloads K201639 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Beijing Biosis Healing Biolog Ical Technology Co., Ltd.. Cleared May 2021. https://www.510kdatabase.net/k202765/ 2021-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k202765-encore-latex-textured-surgical-gloves-fda-510k.jpg K202765 - ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs K202765 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Careplus (M) Sdn Bhd. Cleared May 2021. https://www.510kdatabase.net/k211057/ 2021-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k211057-ligapass-spinal-system-cd-horizon-fda-510k.jpg K211057 - LigaPASS® Spinal System, CD Horizon™ Spinal System K211057 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic, Inc.. Cleared May 2021. https://www.510kdatabase.net/k211134/ 2021-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k211134-bib-stent-placement-catheter-fda-510k.jpg K211134 - BIB Stent Placement Catheter K211134 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: NuMED, Inc.. Cleared May 2021. https://www.510kdatabase.net/k211282/ 2021-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k211282-aqua-medical-rf-vapor-system-fda-510k.jpg K211282 - Aqua Medical RF Vapor System K211282 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Aqua Medical, Inc.. Cleared May 2021. https://www.510kdatabase.net/k211307/ 2021-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k211307-galastitch-absorbable-monofilament-fda-510k.jpg K211307 - GalaSTITCH Absorbable Monofilament Suture K211307 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Tepha, Inc.. Cleared May 2021. https://www.510kdatabase.net/den190043/ 2021-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/den190043-safebreak-vascular-fda-510k.jpg DEN190043 - SafeBreak Vascular DEN190043 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Site Saver, Inc. D/B/A Lineus Medical. Cleared May 2021. https://www.510kdatabase.net/k202832/ 2021-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k202832-implacil-implant-system-fda-510k.jpg K202832 - Implacil Implant System K202832 is a FDA 510(k) cleared dental medical device. Manufacturer: Implacil DE Bortoli Material Odontologico Ltda. Cleared May 2021. https://www.510kdatabase.net/k203196/ 2021-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k203196-peak-flow-meter-fda-510k.jpg K203196 - Peak flow meter K203196 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shanghai Sonmol Medical Equipment Co., Ltd.. Cleared May 2021. https://www.510kdatabase.net/k203322/ 2021-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k203322-spyglass-discover-retrieval-basket-fda-510k.jpg K203322 - SpyGlass Discover Retrieval Basket K203322 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared May 2021. https://www.510kdatabase.net/k210051/ 2021-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k210051-ote-mps-045-multi-purpose-lens-care-fda-510k.jpg K210051 - OTE MPS 045 Multi-purpose Lens Care Solution K210051 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Ote North America, LLC. Cleared May 2021. https://www.510kdatabase.net/k210520/ 2021-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k210520-disposable-synthetic-examination-gloves-fda-510k.jpg K210520 - Disposable Synthetic Examination Gloves K210520 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shandong Shengshixincheng Medical Science & Technology Co.,. Cleared May 2021. https://www.510kdatabase.net/k211098/ 2021-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k211098-breast-volume-navigator-bvn-model-g-2000-fda-510k.jpg K211098 - Breast Volume Navigator (BVN) Model G-2000 K211098 is a FDA 510(k) cleared radiology medical device. Manufacturer: Metritrack, Inc.. Cleared May 2021. https://www.510kdatabase.net/k211251/ 2021-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k211251-vipercath-xc-peripheral-exchange-fda-510k.jpg K211251 - ViperCath XC Peripheral Exchange Catheter K211251 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cardiovascular Systems, Inc.. Cleared May 2021. https://www.510kdatabase.net/k211253/ 2021-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k211253-plasmawave-fda-510k.jpg K211253 - PlasmaWave K211253 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Manamed, Inc.. Cleared May 2021. https://www.510kdatabase.net/k211258/ 2021-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k211258-endoskeleton-tc-interbody-system-fda-510k.jpg K211258 - Endoskeleton TC Interbody System, Endoskeleton TCS Interbody System, Endoskeleton TA Interbody System, Endoskeleton TAS & TAS Hyp Interbody System, Endoskeleton TL Interbody System, Endoskeleton TL Hyp. Interbody System, Endoskeleton TO Interbody System, Endoskeleton TT Interbody System K211258 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared May 2021. https://www.510kdatabase.net/k211292/ 2021-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k211292-fassier-duval-telescopic-im-system-fda-510k.jpg K211292 - Fassier-Duval Telescopic IM System K211292 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Pega Medical, Inc.. Cleared May 2021. https://www.510kdatabase.net/k203144/ 2021-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k203144-micropen-evo-fda-510k.jpg K203144 - MicroPen EVO K203144 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Eclipse Medcorp, LLC. Cleared May 2021. https://www.510kdatabase.net/k203724/ 2021-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k203724-hero-graft-hero-adapter-fda-510k.jpg K203724 - HeRO Graft, HeRO Adapter K203724 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared May 2021. https://www.510kdatabase.net/k203760/ 2021-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k203760-tokuyama-universal-bond-ii-fda-510k.jpg K203760 - Tokuyama Universal Bond II K203760 is a FDA 510(k) cleared dental medical device. Manufacturer: Tokuyama Dental Corporation. Cleared May 2021. https://www.510kdatabase.net/k210608/ 2021-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k210608-lux-dx-insertable-cardiac-monitor-fda-510k.jpg K210608 - LUX-Dx Insertable Cardiac Monitor K210608 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared May 2021. https://www.510kdatabase.net/k210915/ 2021-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k210915-pathfinder-endoscope-cap-fda-510k.jpg K210915 - Pathfinder Endoscope Cap K210915 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Neptune Medical, Inc.. Cleared May 2021. https://www.510kdatabase.net/k210977/ 2021-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k210977-e-dent-1000-fda-510k.jpg K210977 - E-Dent 1000 K210977 is a FDA 510(k) cleared dental medical device. Manufacturer: Envisiontec GmbH. Cleared May 2021. https://www.510kdatabase.net/k211275/ 2021-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k211275-airmax-procedure-mask-fda-510k.jpg K211275 - AirMax Procedure Mask K211275 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Premiumestore, LLC. Cleared May 2021. https://www.510kdatabase.net/k211313/ 2021-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k211313-maxframe-multi-axial-correction-system-fda-510k.jpg K211313 - MAXFRAME Multi-Axial Correction System (aka MAXFRAME) K211313 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes USA Products, LLC. Cleared May 2021. https://www.510kdatabase.net/k211460/ 2021-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k211460-air-relax-plus-model-ar-30-fda-510k.jpg K211460 - Air Relax Plus Model AR-3.0 K211460 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Diode Art Engineering Doing Business AS Air Relax. Cleared May 2021. https://www.510kdatabase.net/k210214/ 2021-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k210214-nuvasive-modulus-expandable-posterior-fda-510k.jpg K210214 - NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System K210214 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared May 2021. https://www.510kdatabase.net/k210425/ 2021-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k210425-catalyft-pl-expandable-interbody-system-fda-510k.jpg K210425 - Catalyft PL Expandable Interbody System K210425 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared May 2021. https://www.510kdatabase.net/k210535/ 2021-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k210535-ultralight-led-system-fda-510k.jpg K210535 - UltraLight LED System K210535 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Rohrer Aesthetics, LLC. Cleared May 2021. https://www.510kdatabase.net/k210975/ 2021-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k210975-bausch-lomb-kalifilcon-a-soft-fda-510k.jpg K210975 - Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia K210975 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Bausch & Lomb, Incorporated. Cleared May 2021. https://www.510kdatabase.net/k211246/ 2021-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k211246-legion-cr-porous-plus-ha-femoral-fda-510k.jpg K211246 - LEGION CR Porous Plus HA Femoral Components K211246 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared May 2021. https://www.510kdatabase.net/k190703/ 2021-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k190703-neuro-iom-system-with-neuro-iomnet-fda-510k.jpg K190703 - Neuro-IOM system with Neuro-IOM.NET software K190703 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neurosoft , Ltd.. Cleared May 2021. https://www.510kdatabase.net/k201192/ 2021-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k201192-impla-nx-model-ise-270m-fda-510k.jpg K201192 - Impla-NX (Model: ISE-270M) K201192 is a FDA 510(k) cleared dental medical device. Manufacturer: Micro-Nx Co., Ltd.. Cleared May 2021. https://www.510kdatabase.net/k201461/ 2021-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k201461-manual-wheelchair-model-a011-fda-510k.jpg K201461 - Manual Wheelchair, Model A011 K201461 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Ningbo Shenyu Medical Equipment Co.,Ltd. Cleared May 2021. https://www.510kdatabase.net/k202299/ 2021-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k202299-ultrasonic-surgical-aspirator-system-fda-510k.jpg K202299 - Ultrasonic Surgical Aspirator System K202299 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smtp Technology Co., Ltd.. Cleared May 2021. https://www.510kdatabase.net/k202359/ 2021-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k202359-zio-monitor-fda-510k.jpg K202359 - Zio Monitor K202359 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: iRhythm Technologies, Inc.. Cleared May 2021. https://www.510kdatabase.net/k202527/ 2021-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k202527-zio-ecg-utilization-software-zeus-system-fda-510k.jpg K202527 - Zio ECG Utilization Software (ZEUS) System K202527 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: iRhythm Technologies, Inc.. Cleared May 2021. https://www.510kdatabase.net/k203806/ 2021-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k203806-jwx-1-plus-navigo-16navigo-24-fda-510k.jpg K203806 - JWX-1 Plus (Navigo 16/Navigo 24) K203806 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Yamaha Motor Co., Ltd.. Cleared May 2021. https://www.510kdatabase.net/k210119/ 2021-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k210119-ipl-hair-removal-device-model-kca423-fda-510k.jpg K210119 - IPL Hair Removal Device (Model: KCA423) K210119 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd.. Cleared May 2021. https://www.510kdatabase.net/k210358/ 2021-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k210358-neurescue-device-fda-510k.jpg K210358 - Neurescue device K210358 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Neurescue Aps. Cleared May 2021. https://www.510kdatabase.net/k211273/ 2021-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k211273-harmonic-hand-piece-blue-harmonic-hand-fda-510k.jpg K211273 - Harmonic Hand Piece, Blue, Harmonic Hand Piece, Gray K211273 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon Endo-Surgery, LLC. Cleared May 2021. https://www.510kdatabase.net/k211312/ 2021-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k211312-universal-viewer-fda-510k.jpg K211312 - Universal Viewer K211312 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared May 2021. https://www.510kdatabase.net/k211423/ 2021-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k211423-rover-fda-510k.jpg K211423 - Rover K211423 is a FDA 510(k) cleared radiology medical device. Manufacturer: Micro-X Limited. Cleared May 2021. https://www.510kdatabase.net/k202716/ 2021-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k202716-ignite-anatomic-shoulder-system-fda-510k.jpg K202716 - Ignite Anatomic Shoulder System K202716 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ignite Orthopedics, LLC. Cleared May 2021. https://www.510kdatabase.net/k202899/ 2021-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k202899-procedure-mask-surgical-mask-fda-510k.jpg K202899 - Procedure Mask, Surgical Mask K202899 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Kenpax International Limited. Cleared May 2021. https://www.510kdatabase.net/k202919/ 2021-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k202919-ats-5000-automatic-tourniquet-instrument-fda-510k.jpg K202919 - ATS 5000 Automatic Tourniquet Instrument K202919 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Mcewen and Associates Consulting , Ltd.. Cleared May 2021. https://www.510kdatabase.net/k203331/ 2021-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k203331-quick-20m-fda-510k.jpg K203331 - Quick-20m K203331 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cgx, LLC. Cleared May 2021. https://www.510kdatabase.net/k203377/ 2021-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k203377-vr101-lubricating-intravaginal-ring-fda-510k.jpg K203377 - VR101 Lubricating Intravaginal Ring K203377 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: J3 Bioscience, Inc.. Cleared May 2021. https://www.510kdatabase.net/k203415/ 2021-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k203415-surgical-isolation-gown-fda-510k.jpg K203415 - Surgical Isolation Gown K203415 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Yanbian Pacific Textile Co., Ltd.. Cleared May 2021. https://www.510kdatabase.net/k203440/ 2021-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k203440-penumbra-system-reperfusion-catheter-fda-510k.jpg K203440 - Penumbra System (Reperfusion Catheter RED 62) K203440 is a FDA 510(k) cleared neurology medical device. Manufacturer: Penumbra, Inc.. Cleared May 2021. https://www.510kdatabase.net/k203583/ 2021-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k203583-yuwell-infrared-ear-thermometer-yht101-fda-510k.jpg K203583 - YUWELL infrared ear thermometer: YHT101, YHT200 K203583 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Yuyue Medical Equipment& Supply Co., Ltd.. Cleared May 2021. https://www.510kdatabase.net/k210086/ 2021-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k210086-vitals360-multi-vitals-mobile-monitor-fda-510k.jpg K210086 - Vitals360 Multi-Vitals Mobile Monitor K210086 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vocare, Inc.. Cleared May 2021. https://www.510kdatabase.net/k210257/ 2021-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k210257-xoran-workstation-model-10050-fda-510k.jpg K210257 - Xoran Workstation, Model 10050 K210257 is a FDA 510(k) cleared radiology medical device. Manufacturer: Xoran Technologies, LLC. Cleared May 2021. https://www.510kdatabase.net/k210476/ 2021-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k210476-echotip-ultra-endoscopic-ultrasound-fda-510k.jpg K210476 - EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy Needle K210476 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Ireland, Ltd.. Cleared May 2021. https://www.510kdatabase.net/k210581/ 2021-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k210581-actis-duofix-hip-prosthesis-collarless-fda-510k.jpg K210581 - Actis DuoFix Hip Prosthesis- Collarless K210581 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Ireland UC. Cleared May 2021. https://www.510kdatabase.net/k211001/ 2021-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k211001-c-qual-m-breastboard-fda-510k.jpg K211001 - C-Qual M™ Breastboard K211001 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medtec, Inc. Dba Civco Medical Solutions and Civco. Cleared May 2021. https://www.510kdatabase.net/k201569/ 2021-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k201569-cuvis-spine-fda-510k.jpg K201569 - CUVIS-spine K201569 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Curexo, Inc.. Cleared May 2021. https://www.510kdatabase.net/k201576/ 2021-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k201576-disposable-latex-powder-free-fda-510k.jpg K201576 - Disposable Latex Powder Free Examination Gloves (Non-sterile) K201576 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Pt. Universal Gloves. Cleared May 2021. https://www.510kdatabase.net/k202593/ 2021-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k202593-turbett-instrument-pod-fda-510k.jpg K202593 - Turbett Instrument Pod K202593 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Turbett Surgical, Inc.. Cleared May 2021. https://www.510kdatabase.net/k202866/ 2021-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k202866-tens-ems-device-fda-510k.jpg K202866 - TENS & EMS Device K202866 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Shenzhen Jian Feng Electronic Technology Co., Ltd.. Cleared May 2021. https://www.510kdatabase.net/k202955/ 2021-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k202955-contour-light-cl-100-fda-510k.jpg K202955 - Contour Light CL-100 K202955 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Contour Research, LLC. Cleared May 2021. https://www.510kdatabase.net/k203282/ 2021-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k203282-techfit-patient-specific-maxillofacial-fda-510k.jpg K203282 - TECHFIT Patient-Specific Maxillofacial System K203282 is a FDA 510(k) cleared dental medical device. Manufacturer: Industrias Medicas Sampedro S.A.S. Cleared May 2021. https://www.510kdatabase.net/k210187/ 2021-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k210187-overjet-dental-assist-fda-510k.jpg K210187 - Overjet Dental Assist K210187 is a FDA 510(k) cleared radiology medical device. Manufacturer: Overjet, Inc.. Cleared May 2021. https://www.510kdatabase.net/k210237/ 2021-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k210237-cina-chest-fda-510k.jpg K210237 - CINA CHEST K210237 is a FDA 510(k) cleared radiology medical device. Manufacturer: Avicenna.Ai. Cleared May 2021. https://www.510kdatabase.net/k210306/ 2021-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k210306-gii-spinal-fixation-system-fda-510k.jpg K210306 - GII Spinal Fixation System K210306 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Coligne AG. Cleared May 2021. https://www.510kdatabase.net/k210394/ 2021-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k210394-electrosurgical-accessory-fda-510k.jpg K210394 - Electrosurgical accessory K210394 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Dornier Medtech America, Inc.. Cleared May 2021. https://www.510kdatabase.net/k210540/ 2021-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k210540-ohlendorf-clear-aligner-fda-510k.jpg K210540 - Ohlendorf Clear Aligner K210540 is a FDA 510(k) cleared dental medical device. Manufacturer: Ohlendorf Appliance Laboratory. Cleared May 2021. https://www.510kdatabase.net/k210553/ 2021-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k210553-steam-dot-process-indicator-fda-510k.jpg K210553 - Steam-Dot Process Indicator K210553 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Propper Manufacturing Co., Inc.. Cleared May 2021. https://www.510kdatabase.net/k210880/ 2021-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k210880-vereos-petct-fda-510k.jpg K210880 - Vereos PET/CT K210880 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared May 2021. https://www.510kdatabase.net/k202423/ 2021-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k202423-microscan-microstrep-plus-panels-with-fda-510k.jpg K202423 - MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 µg/mL) K202423 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared May 2021. https://www.510kdatabase.net/k202458/ 2021-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k202458-bonos-inject-pedicle-screw-kits-cement-fda-510k.jpg K202458 - BonOs Inject, Pedicle screw kits, Cement pusher K202458 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osartis GmbH. Cleared May 2021. https://www.510kdatabase.net/k202667/ 2021-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k202667-personal-lubricant-jelly-fda-510k.jpg K202667 - Personal Lubricant Jelly K202667 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Nantong Health & Beyond Hygienic Products, Inc.. Cleared May 2021. https://www.510kdatabase.net/k202709/ 2021-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k202709-disposable-powered-endoscopic-linear-fda-510k.jpg K202709 - Disposable Powered Endoscopic Linear Cutting Staplers and Cartridges K202709 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ningbo Verykind Medical Device Co., Ltd.. Cleared May 2021. https://www.510kdatabase.net/k210816/ 2021-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k210816-true-tulip-true-mis-fda-510k.jpg K210816 - True Tulip, True M.I.S. K210816 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Innovative Surgical Designs, Inc.. Cleared May 2021. https://www.510kdatabase.net/k210829/ 2021-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k210829-persona-revision-knee-system-femoral-fda-510k.jpg K210829 - Persona Revision Knee System Femoral Metaphyseal Cones K210829 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared May 2021. https://www.510kdatabase.net/k202793/ 2021-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k202793-cercare-medical-neurosuite-fda-510k.jpg K202793 - Cercare Medical Neurosuite K202793 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cercare Medical Aps. Cleared May 2021. https://www.510kdatabase.net/k203682/ 2021-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k203682-electrosurgical-generator-esg-400-foot-fda-510k.jpg K203682 - Electrosurgical Generator ESG-400, Foot Switches, POWERSEAL Curved Jaw Sealer and Divider, Double Action K203682 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Olympus Winter & Ibe GmbH. Cleared May 2021. https://www.510kdatabase.net/k210217/ 2021-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k210217-needleless-connector-fda-510k.jpg K210217 - Needleless Connector K210217 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Caina Medical Co.,Ltd. Cleared May 2021. https://www.510kdatabase.net/k210460/ 2021-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k210460-nitritec-vinyl-glove-powder-free-blue-fda-510k.jpg K210460 - NitriTec Vinyl Glove Powder Free Blue K210460 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zhonghong Pulin Medical Products Co., Ltd.. Cleared May 2021. https://www.510kdatabase.net/k211037/ 2021-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k211037-vantage-galan-3t-mrt-3020-v60-with-fda-510k.jpg K211037 - Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR K211037 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared May 2021. https://www.510kdatabase.net/k211105/ 2021-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k211105-ear-friendly-mask-fda-510k.jpg K211105 - Ear-Friendly Mask K211105 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ray Co., Ltd.. Cleared May 2021. https://www.510kdatabase.net/k200573/ 2021-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k200573-bonetrust-mini-implant-system-fda-510k.jpg K200573 - BoneTrust Mini Implant System K200573 is a FDA 510(k) cleared dental medical device. Manufacturer: Medical Instinct Deutschland GmbH. Cleared May 2021. https://www.510kdatabase.net/k202138/ 2021-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k202138-cardiac-trigger-monitor-fda-510k.jpg K202138 - Cardiac Trigger Monitor K202138 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ivy Biomedical Systems, Inc.. Cleared May 2021. https://www.510kdatabase.net/k202747/ 2021-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k202747-klarity-bolus-fda-510k.jpg K202747 - Klarity Bolus K202747 is a FDA 510(k) cleared radiology medical device. Manufacturer: Klarity Medical & Equipment (GZ) Co., Ltd.. Cleared May 2021. https://www.510kdatabase.net/k202862/ 2021-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k202862-gx-ivf-gx-tl-gx-mops-plus-fda-510k.jpg K202862 - Gx-IVF, Gx-TL, Gx-MOPS PLUS K202862 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Vitrolife Sweden AB. Cleared May 2021. https://www.510kdatabase.net/k203226/ 2021-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k203226-telescope-0-o-10mm-wl-305mm-telescope-fda-510k.jpg K203226 - TELESCOPE 0 O 10MM WL 305MM / TELESCOPE 30 O 10MM WL 305MM / TELESCOPE 50 O 10MM WL 305MM, TELESCOPE 0 O 10MM WL 440MM / TELESCOPE 30 O 10MM WL 440MM / TELESCOPE 50 O 10MM WL 440MM K203226 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Richard Wolf Medical Instruments Corporation. Cleared May 2021. https://www.510kdatabase.net/k210072/ 2021-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k210072-holoscope-i-fda-510k.jpg K210072 - HOLOSCOPE-i K210072 is a FDA 510(k) cleared radiology medical device. Manufacturer: Real View Imaging , Ltd.. Cleared May 2021. https://www.510kdatabase.net/k210200/ 2021-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k210200-1-ml-sterile-hypodermic-syringe-for-fda-510k.jpg K210200 - 1 ml Sterile Hypodermic Syringe For Single Use. With/Without Needle. Luer/Luer-Lock K210200 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Set Medikal Sanayi VE Ticaret Anonim Sirketi. Cleared May 2021. https://www.510kdatabase.net/k210302/ 2021-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k210302-disposable-medical-mask-fda-510k.jpg K210302 - Disposable Medical mask K210302 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Anhui Jbh Medical Apparatus Co., Ltd.. Cleared May 2021. https://www.510kdatabase.net/k210417/ 2021-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k210417-sequential-circulators-sc-1004-dl-sc-fda-510k.jpg K210417 - Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL K210417 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bio Compression Systems, Inc.. Cleared May 2021. https://www.510kdatabase.net/k210774/ 2021-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k210774-powder-free-vinyl-patient-examination-fda-510k.jpg K210774 - Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) K210774 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shandong Jieshi Medical Products Co., Ltd.. Cleared May 2021. https://www.510kdatabase.net/k210780/ 2021-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k210780-powder-free-vinyl-patient-examination-fda-510k.jpg K210780 - Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) K210780 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shandong Shangwei Medical Products Co., Ltd.. Cleared May 2021. https://www.510kdatabase.net/k210799/ 2021-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k210799-powder-free-vinyl-patient-examination-fda-510k.jpg K210799 - Powder Free Vinyl Patient Examination Gloves K210799 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Yunnan Huazhiyuan Medical Technology Co., Ltd.. Cleared May 2021. https://www.510kdatabase.net/k210942/ 2021-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k210942-microfrance-monopolar-and-bipolar-fda-510k.jpg K210942 - MicroFrance Monopolar and Bipolar Electrosurgical Instruments K210942 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Integra Microfrance. Cleared May 2021. https://www.510kdatabase.net/k211100/ 2021-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k211100-acqguide-max-steerable-sheath-fda-510k.jpg K211100 - AcQGuide MAX Steerable Sheath K211100 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Acutus Medical, Inc.. Cleared May 2021. https://www.510kdatabase.net/k211130/ 2021-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k211130-npseal-fda-510k.jpg K211130 - NPseal K211130 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Guard Medical, Inc.. Cleared May 2021. https://www.510kdatabase.net/k200555/ 2021-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k200555-prevest-denpro-dental-cements-micron-fda-510k.jpg K200555 - Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner) K200555 is a FDA 510(k) cleared dental medical device. Manufacturer: Prevest Denpro Limited. Cleared May 2021. https://www.510kdatabase.net/k202697/ 2021-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k202697-united-sewing-high-fluid-resistant-fda-510k.jpg K202697 - United Sewing High Fluid Resistant Disposable Face Mask, United Sewing High Fluid Resistant Surgical Mask, United Sewing High Fluid Resistant Procedure Mask K202697 is a FDA 510(k) cleared general hospital medical device. Manufacturer: United Sewing Automation, Inc.. Cleared May 2021. https://www.510kdatabase.net/k202924/ 2021-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k202924-linksymphoknee-system-fda-510k.jpg K202924 - LinkSymphoKnee System K202924 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Waldemar Link GmbH & Co. KG. Cleared May 2021. https://www.510kdatabase.net/k203481/ 2021-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k203481-cryovive-fda-510k.jpg K203481 - CryoVIVE K203481 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Recensmedical, Inc.. Cleared May 2021. https://www.510kdatabase.net/k203566/ 2021-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k203566-tablet-application-fda-510k.jpg K203566 - Tablet Application K203566 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew. Cleared May 2021. https://www.510kdatabase.net/k210369/ 2021-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k210369-powder-free-nitrile-examination-glove-fda-510k.jpg K210369 - Powder Free Nitrile Examination Glove K210369 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Pastel Glove Sdn Bhd. Cleared May 2021. https://www.510kdatabase.net/k210426/ 2021-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k210426-hs40-diagnostic-ultrasound-system-fda-510k.jpg K210426 - HS40 Diagnostic Ultrasound System K210426 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Medison Co., Ltd.. Cleared May 2021. https://www.510kdatabase.net/k210485/ 2021-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k210485-pentax-medical-video-upper-gi-scopes-fda-510k.jpg K210485 - PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family) K210485 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Pentax of America, Inc.. Cleared May 2021. https://www.510kdatabase.net/k210815/ 2021-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k210815-disposable-face-mask-fda-510k.jpg K210815 - Disposable Face Mask K210815 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Biobase Scientific (Shandong) Co., Ltd.. Cleared May 2021. https://www.510kdatabase.net/k210874/ 2021-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k210874-reliance-spinal-screw-system-fda-510k.jpg K210874 - Reliance Spinal Screw System K210874 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Reliance Medical Systems, LLC. Cleared May 2021. https://www.510kdatabase.net/k210979/ 2021-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k210979-prelivia-fda-510k.jpg K210979 - Prelivia K210979 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Rehabtronics, Inc.. Cleared May 2021. https://www.510kdatabase.net/k211004/ 2021-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k211004-gmk-spherika-femurs-and-fixed-tibial-fda-510k.jpg K211004 - GMK Spherika Femurs and Fixed Tibial Trays Plus K211004 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared May 2021. https://www.510kdatabase.net/k211115/ 2021-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k211115-a1at-genotyping-test-fda-510k.jpg K211115 - A1AT Genotyping Test K211115 is a FDA 510(k) cleared immunology medical device. Manufacturer: Progenika Biopharma S.A., A Grifols Company. Cleared May 2021. https://www.510kdatabase.net/k211118/ 2021-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k211118-signa-70t-fda-510k.jpg K211118 - SIGNA 7.0T K211118 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems, LLC. Cleared May 2021. https://www.510kdatabase.net/k210153/ 2021-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k210153-nextar-rsa-platform-fda-510k.jpg K210153 - NextAR RSA Platform K210153 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared May 2021. https://www.510kdatabase.net/k210435/ 2021-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k210435-automatic-arm-electronic-blood-fda-510k.jpg K210435 - Automatic Arm Electronic Blood Pressure Monitor K210435 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Lepu Intelligent Medical Equipment Co., Ltd.. Cleared May 2021. https://www.510kdatabase.net/k210439/ 2021-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k210439-nuvasive-mod-ex-xlif-interbody-system-fda-510k.jpg K210439 - NuVasive MOD-EX XLIF Interbody System K210439 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared May 2021. https://www.510kdatabase.net/k210557/ 2021-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k210557-symbia-va10a-family-fda-510k.jpg K210557 - Symbia VA10A Family K210557 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 2021. https://www.510kdatabase.net/k210689/ 2021-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k210689-clottriever-thrombectomy-system-fda-510k.jpg K210689 - ClotTriever Thrombectomy System K210689 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inari Medical, Inc.. Cleared May 2021. https://www.510kdatabase.net/k210737/ 2021-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k210737-system-1e-liquid-chemical-sterilant-fda-510k.jpg K210737 - SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900, S40 Sterilant Concentrate K210737 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared May 2021. https://www.510kdatabase.net/k210809/ 2021-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k210809-itotal-identity-cruciate-retaining-cr-fda-510k.jpg K210809 - iTotal® Identity™ Cruciate Retaining (CR) Knee Replacement System (KRS) K210809 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Conformis, Inc.. Cleared May 2021. https://www.510kdatabase.net/k210974/ 2021-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k210974-high-performance-antimicrobial-gelling-fda-510k.jpg K210974 - High Performance Antimicrobial Gelling Fiber with Silver K210974 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Advanced Medical Solutions, Ltd.. Cleared May 2021. https://www.510kdatabase.net/k202272/ 2021-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k202272-hd-mediastinoscope-fda-510k.jpg K202272 - HD Mediastinoscope K202272 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared May 2021. https://www.510kdatabase.net/k202860/ 2021-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k202860-valley-contax-single-vision-sv-gas-fda-510k.jpg K202860 - Valley Contax Single Vision (SV) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax Goldeneye Aspheric Front Multifocal (AFM) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax V Kone (VK) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A) K202860 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Valley Contax, Inc.. Cleared May 2021. https://www.510kdatabase.net/k202973/ 2021-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k202973-hanarostent-benefit-biliary-nnn-fda-510k.jpg K202973 - HANAROSTENT Benefit Biliary (NNN) K202973 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: M.I. Tech Co., Ltd.. Cleared May 2021. https://www.510kdatabase.net/k203228/ 2021-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k203228-dart-fire-edge-cannulated-screw-system-fda-510k.jpg K203228 - DART-FIRE EDGE Cannulated Screw System K203228 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wright Medical. Cleared May 2021. https://www.510kdatabase.net/k210572/ 2021-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k210572-neurodyn-v20-neurodyn-aussie-v20-fda-510k.jpg K210572 - Neurodyn V2.0, Neurodyn Aussie V2.0 K210572 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Ibramed Equipamentos Medicos. Cleared May 2021. https://www.510kdatabase.net/k210967/ 2021-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k210967-air-pressure-therapy-system-vu-ipc06-fda-510k.jpg K210967 - Air Pressure Therapy System: VU-IPC06 K210967 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Xiamen Weiyou Intelligent Technology Co., Ltd.. Cleared May 2021. https://www.510kdatabase.net/k190737/ 2021-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k190737-solax-electric-scooter-models-s204311m-fda-510k.jpg K190737 - Solax Electric Scooter (Models: S204311M, S204161, S204143) K190737 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Dongguan Prestige Sporting Goods Co., Ltd.. Cleared May 2021. https://www.510kdatabase.net/k193649/ 2021-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k193649-yumizen-c1200-creatinine-pap-fda-510k.jpg K193649 - Yumizen C1200 Creatinine PAP K193649 is a FDA 510(k) cleared chemistry medical device. Manufacturer: HORIBA ABX SAS. Cleared May 2021. https://www.510kdatabase.net/k201504/ 2021-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k201504-single-use-medical-poly-vinyl-chloride-fda-510k.jpg K201504 - Single-use medical poly (vinyl chloride) examination glove K201504 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Anhui Bytech Medical Supplies Co., Ltd.. Cleared May 2021. https://www.510kdatabase.net/k203311/ 2021-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k203311-choicespine-blackhawk-ti-cervical-fda-510k.jpg K203311 - ChoiceSpine Blackhawk Ti Cervical Spacer System K203311 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Choice Spine, LLC. Cleared May 2021. https://www.510kdatabase.net/k203320/ 2021-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k203320-endo-motor-fda-510k.jpg K203320 - Endo Motor K203320 is a FDA 510(k) cleared dental medical device. Manufacturer: Guilin Woodpecker Medical Instrument Co., Ltd.. Cleared May 2021. https://www.510kdatabase.net/k210168/ 2021-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k210168-diode-laser-therapy-systems-fda-510k.jpg K210168 - Diode Laser Therapy Systems K210168 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Beijing Kes Biology Technology Co., Ltd.. Cleared May 2021. https://www.510kdatabase.net/k202145/ 2021-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k202145-bigfoot-unity-diabetes-management-system-fda-510k.jpg K202145 - Bigfoot Unity Diabetes Management System K202145 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bigfoot Biomedical, Inc.. Cleared May 2021. https://www.510kdatabase.net/k203036/ 2021-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k203036-non-sterile-powder-free-polyurethane-fda-510k.jpg K203036 - Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors) K203036 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Central Medicare Sdn Bhd. Cleared May 2021. https://www.510kdatabase.net/k203572/ 2021-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k203572-karl-storz-radel-sterilization-trays-fda-510k.jpg K203572 - Karl Storz Radel Sterilization Trays K203572 is a FDA 510(k) cleared general hospital medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared May 2021. https://www.510kdatabase.net/k203832/ 2021-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k203832-fuseforce-flex-dynamic-compression-fda-510k.jpg K203832 - FuseForce™ Flex Dynamic Compression System K203832 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wright Medical. Cleared May 2021. https://www.510kdatabase.net/k203847/ 2021-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k203847-reprocessed-tri-pulse-compression-fda-510k.jpg K203847 - Reprocessed Tri Pulse Compression Garment K203847 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Renu Medical, Inc.. Cleared May 2021. https://www.510kdatabase.net/k210218/ 2021-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k210218-surgical-mask-model-namec015-fda-510k.jpg K210218 - SURGICAL MASK, Model Name:C015 K210218 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Qingdao Hainuo Biological Engineering Co., Ltd.. Cleared May 2021. https://www.510kdatabase.net/k210366/ 2021-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k210366-blue-nitrile-powder-free-patient-fda-510k.jpg K210366 - Blue Nitrile Powder Free Patient Examination Glove, Non Sterile K210366 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Onetexx Sdn Bhd. Cleared May 2021. https://www.510kdatabase.net/k210755/ 2021-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k210755-powder-free-nitrile-patient-fda-510k.jpg K210755 - Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Blue) K210755 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Meditech Gloves Sdn Bhd. Cleared May 2021. https://www.510kdatabase.net/k201697/ 2021-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k201697-umbilical-vessels-catheter-fda-510k.jpg K201697 - Umbilical Vessels Catheter K201697 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Haolang Medical USA Corporation. Cleared May 2021. https://www.510kdatabase.net/k201936/ 2021-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k201936-smartsite-bag-500ml-smartsite-bag-250-fda-510k.jpg K201936 - SmartSite Bag 500mL, SmartSite Bag 250 mL, SmartSite Bag 100 mL K201936 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Gilero, LLC. Cleared May 2021. https://www.510kdatabase.net/k202031/ 2021-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k202031-talent-pro-electromagnetic-stimulator-fda-510k.jpg K202031 - Talent-Pro Electromagnetic Stimulator K202031 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Remed Co., Ltd.. Cleared May 2021. https://www.510kdatabase.net/k202578/ 2021-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k202578-kardiflex-nc-coronary-dilatation-fda-510k.jpg K202578 - KardiFlex NC Coronary Dilatation Catheter K202578 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medcaptain Life Science Co., Ltd.. Cleared May 2021. https://www.510kdatabase.net/k202598/ 2021-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k202598-3-layer-surgical-mask-with-ear-loops-fda-510k.jpg K202598 - 3 Layer Surgical Mask with Ear Loops Level 1, 3 Layer Surgical Mask with Ties Level 1, 3 Layer Surgical Mask with Ear Loops Level 2, 3 Layer Surgical Mask with Ties Level 2, 3 Layer Surgical Mask with Ear Loops Level 3, 3 Layer Surgical Marks with Ties Level 3 K202598 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3A Medical Products Co., Ltd.. Cleared May 2021. https://www.510kdatabase.net/k202971/ 2021-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k202971-drpx-locking-distal-radius-plate-system-fda-510k.jpg K202971 - DRPx Locking Distal Radius Plate System K202971 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthopaedic Implant Company. Cleared May 2021. https://www.510kdatabase.net/k203183/ 2021-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k203183-coolseal-trinity-30-cm-shaft-37-cm-fda-510k.jpg K203183 - CoolSeal Trinity (30 cm shaft, 37 cm shaft, and 44 cm shaft) K203183 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bolder Surgical, LLC. Cleared May 2021. https://www.510kdatabase.net/k203640/ 2021-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k203640-coolseal-reveal-fda-510k.jpg K203640 - CoolSeal Reveal K203640 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bolder Surgical, LLC. Cleared May 2021. https://www.510kdatabase.net/k210066/ 2021-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k210066-imagepilot-fda-510k.jpg K210066 - ImagePilot K210066 is a FDA 510(k) cleared radiology medical device. Manufacturer: Konica Minolta, Inc.. Cleared May 2021. https://www.510kdatabase.net/k210191/ 2021-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k210191-identity-imprint-knee-replacement-system-fda-510k.jpg K210191 - Identity Imprint Knee Replacement System K210191 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Conformis, Inc.. Cleared May 2021. https://www.510kdatabase.net/k210353/ 2021-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k210353-autocap-rx-fda-510k.jpg K210353 - AutoCap RX K210353 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared May 2021. https://www.510kdatabase.net/k210529/ 2021-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k210529-dr-yglo-wart-remover-fda-510k.jpg K210529 - Dr. Yglo Wart Remover K210529 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Theotclab Healthcare B.V.. Cleared May 2021. https://www.510kdatabase.net/k210705/ 2021-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k210705-defender-safety-procedure-mask-level-1-fda-510k.jpg K210705 - Defender Safety Procedure Mask Level 1, Defender Safety Procedure Mask Level 3, Defender Safety Surgical Mask Level 3 K210705 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Defender Safety, Inc.. Cleared May 2021. https://www.510kdatabase.net/k210728/ 2021-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k210728-conduit-instruments-fda-510k.jpg K210728 - CONDUIT Instruments K210728 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International SARL. Cleared May 2021. https://www.510kdatabase.net/k211034/ 2021-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k211034-corvus-radiation-therapy-planning-system-fda-510k.jpg K211034 - Corvus Radiation Therapy Planning System K211034 is a FDA 510(k) cleared radiology medical device. Manufacturer: Best Nomos. Cleared May 2021. https://www.510kdatabase.net/k200765/ 2021-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k200765-genius-genuin-total-knee-system-fda-510k.jpg K200765 - Genius / Genuin Total Knee System K200765 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biorad Medisys Pvt, Ltd.. Cleared May 2021. https://www.510kdatabase.net/k203525/ 2021-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k203525-d-function-fda-510k.jpg K203525 - D function K203525 is a FDA 510(k) cleared dental medical device. Manufacturer: Ito Co., Ltd.. Cleared May 2021. https://www.510kdatabase.net/k210298/ 2021-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k210298-gr-14-resin-system-fda-510k.jpg K210298 - GR-14 Resin System K210298 is a FDA 510(k) cleared dental medical device. Manufacturer: Pro3dure Medical GmbH. Cleared May 2021. https://www.510kdatabase.net/k210451/ 2021-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k210451-orthogold-100-fda-510k.jpg K210451 - OrthoGold 100 K210451 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Tissue Regeneration Technologies, LLC. Cleared May 2021. https://www.510kdatabase.net/k211008/ 2021-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k211008-bose-soundcontrol-hearing-aids-fda-510k.jpg K211008 - Bose SoundControl Hearing Aids K211008 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Bose Corporation. Cleared May 2021. https://www.510kdatabase.net/k211112/ 2021-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k211112-oic-external-fixation-system-fda-510k.jpg K211112 - OIC External Fixation System K211112 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthopaedic Implant Company. Cleared May 2021. https://www.510kdatabase.net/k200768/ 2021-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k200768-rebellion-phantom-multi-bite-kerrison-fda-510k.jpg K200768 - Rebellion, Phantom Multi-Bite Kerrison Rongeur  K200768 is a FDA 510(k) cleared neurology medical device. Manufacturer: Morpheus AG. Cleared May 2021. https://www.510kdatabase.net/k200893/ 2021-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k200893-prontopump-sterile-tube-set-fda-510k.jpg K200893 - ProntoPump Sterile Tube Set K200893 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ipax, Inc.. Cleared May 2021. https://www.510kdatabase.net/k201152/ 2021-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k201152-electric-breast-pump-fda-510k.jpg K201152 - Electric Breast Pump K201152 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Guangdong Horigen Mother & Baby Products Co., Ltd.. Cleared May 2021. https://www.510kdatabase.net/k201671/ 2021-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k201671-a-link-z-fda-510k.jpg K201671 - A-Link Z K201671 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Acuity Surgical Devices, LLC. Cleared May 2021. https://www.510kdatabase.net/k202521/ 2021-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k202521-ptolemedic-system-fda-510k.jpg K202521 - PtoleMedic System K202521 is a FDA 510(k) cleared radiology medical device. Manufacturer: Lento Medical Innovation, Inc.. Cleared May 2021. https://www.510kdatabase.net/k202921/ 2021-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k202921-uro-g-cystoscope-fda-510k.jpg K202921 - Uro-G Cystoscope K202921 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Uroviu Corporation. Cleared May 2021. https://www.510kdatabase.net/k203135/ 2021-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k203135-medline-vacu-line-suction-aspirator-fda-510k.jpg K203135 - Medline Vacu-line Suction Aspirator K203135 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medline Industries, Inc.. Cleared May 2021. https://www.510kdatabase.net/k203192/ 2021-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k203192-navicam-xpress-stomach-system-fda-510k.jpg K203192 - NaviCam Xpress Stomach System K203192 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Anx Robotica Corp. Cleared May 2021. https://www.510kdatabase.net/k203218/ 2021-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k203218-cap-spheres-pellet-pack-fda-510k.jpg K203218 - CaP Spheres Pellet Pack K203218 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer Biomet Spine, Inc.. Cleared May 2021. https://www.510kdatabase.net/k203450/ 2021-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k203450-esophacap-swallowable-cellular-fda-510k.jpg K203450 - EsophaCap Swallowable Cellular Retrieval Device (changed from Cell-Mata) K203450 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Capnostics, LLC. Cleared May 2021. https://www.510kdatabase.net/k203529/ 2021-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k203529-vassallo-gt-hybrid-fda-510k.jpg K203529 - VASSALLO GT Hybrid K203529 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Filmecc Co., Ltd.. Cleared May 2021. https://www.510kdatabase.net/k203655/ 2021-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k203655-reprocessed-webster-cs-bi-directional-fda-510k.jpg K203655 - Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID) K203655 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Innovative Health, LLC. Cleared May 2021. https://www.510kdatabase.net/k203698/ 2021-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k203698-colink-sfx-implant-system-fda-510k.jpg K203698 - CoLink Sfx Implant System K203698 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: In2bones USA, LLC. Cleared May 2021. https://www.510kdatabase.net/k210304/ 2021-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k210304-surgical-mask-fda-510k.jpg K210304 - Surgical Mask K210304 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jin Pin Electrical Co., Ltd. Zhuhai S.E.Z.. Cleared May 2021. https://www.510kdatabase.net/k210669/ 2021-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k210669-quantum-mini-ventilation-module-fda-510k.jpg K210669 - Quantum Mini Ventilation Module K210669 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Spectrum Medical , Ltd.. Cleared May 2021. https://www.510kdatabase.net/k210682/ 2021-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k210682-sota-cloud-imaging-fda-510k.jpg K210682 - SOTA Cloud Imaging K210682 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sota Precision Optics, Inc. Dba Sota Imaging. Cleared May 2021. https://www.510kdatabase.net/k203409/ 2021-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k203409-mc3-crescent-jugular-dual-lumen-catheter-fda-510k.jpg K203409 - MC3 Crescent Jugular Dual Lumen Catheter K203409 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Mc3, Inc.. Cleared May 2021. https://www.510kdatabase.net/k203710/ 2021-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k203710-storz-medical-magnetolith-muscle-fda-510k.jpg K203710 - Storz Medical MAGNETOLITH Muscle Stimulator K203710 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Storz Medical AG. Cleared May 2021. https://www.510kdatabase.net/k203749/ 2021-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k203749-ambu-vivasight-2-dlt-ambu-vivasight-2-fda-510k.jpg K203749 - Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cable K203749 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Ambu A/S. Cleared May 2021. https://www.510kdatabase.net/k210675/ 2021-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k210675-easywhip-fda-510k.jpg K210675 - EasyWhip K210675 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Winter Innovations, Inc.. Cleared May 2021. https://www.510kdatabase.net/k201949/ 2021-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k201949-smart-cable-nmt-module-and-accessories-fda-510k.jpg K201949 - Smart Cable NMT Module and Accessories, Life Scope BSM 3000 Series and Life Scope BSM 6000 Series K201949 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Nihon Kohden Corporation. Cleared May 2021. https://www.510kdatabase.net/k202430/ 2021-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k202430-kerecis-reconstruct-fda-510k.jpg K202430 - Kerecis Reconstruct K202430 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Kerecis Limited. Cleared May 2021. https://www.510kdatabase.net/k203165/ 2021-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k203165-disposable-ureteral-access-sheath-fda-510k.jpg K203165 - Disposable Ureteral Access Sheath K203165 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Suzhou Beyo Medical Technology Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k203267/ 2021-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k203267-the-biobrace-implant-fda-510k.jpg K203267 - The BioBrace Implant K203267 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Biorez, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k203580/ 2021-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k203580-artisential-laparoscopic-instruments-fda-510k.jpg K203580 - ArtiSential Laparoscopic Instruments-Electrodes K203580 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Livsmed, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k203601/ 2021-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k203601-innova-nasal-non-vented-mask-fda-510k.jpg K203601 - Innova Nasal Non-Vented Mask K203601 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sleepnet Corporation. Cleared Apr 2021. https://www.510kdatabase.net/k203699/ 2021-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k203699-syngo-ct-extended-functionalities-fda-510k.jpg K203699 - syngo. CT Extended Functionalities K203699 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k203786/ 2021-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k203786-mac-7-resting-ecg-analysis-system-fda-510k.jpg K203786 - MAC 7 - Resting ECG Analysis System K203786 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k210001/ 2021-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k210001-hyper-air-fda-510k.jpg K210001 - HYPER AiR K210001 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k210061/ 2021-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k210061-prolift-lateral-helo-fixated-fda-510k.jpg K210061 - ProLift Lateral HELO Fixated K210061 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k210247/ 2021-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k210247-osteocentric-integrated-hip-fastener-fda-510k.jpg K210247 - OsteoCentric Integrated Hip Fastener System K210247 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteocentric Technologies D.B.A. Osteocentric Trauma. Cleared Apr 2021. https://www.510kdatabase.net/k210290/ 2021-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k210290-jace-medical-thoracic-plating-system-fda-510k.jpg K210290 - JACE Medical Thoracic Plating System K210290 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Jace Medical, LLC. Cleared Apr 2021. https://www.510kdatabase.net/k210637/ 2021-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k210637-cd-horizon-spinal-system-fda-510k.jpg K210637 - CD Horizon™ Spinal System K210637 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic. Cleared Apr 2021. https://www.510kdatabase.net/k210647/ 2021-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k210647-supercross-microcatheter-supercross-ft-fda-510k.jpg K210647 - SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter K210647 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vascular Solutions, LLC. Cleared Apr 2021. https://www.510kdatabase.net/k210919/ 2021-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k210919-acuitydre-fda-510k.jpg K210919 - AcuityDRe K210919 is a FDA 510(k) cleared radiology medical device. Manufacturer: Radmedix, LLC. Cleared Apr 2021. https://www.510kdatabase.net/k210993/ 2021-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k210993-cerelink-icp-monitor-fda-510k.jpg K210993 - CereLink ICP Monitor K210993 is a FDA 510(k) cleared neurology medical device. Manufacturer: Integra Lifesciences Production Corporation. Cleared Apr 2021. https://www.510kdatabase.net/k211013/ 2021-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k211013-flowtriever-retrievalaspiration-system-fda-510k.jpg K211013 - FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24 K211013 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inari Medical, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k201024/ 2021-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k201024-expandable-titanium-pliftlif-system-fda-510k.jpg K201024 - Expandable Titanium PLIF/TLIF System K201024 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spectrum Spine, LLC. Cleared Apr 2021. https://www.510kdatabase.net/k202457/ 2021-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k202457-m1-surgical-face-mask-fda-510k.jpg K202457 - M1 Surgical Face Mask K202457 is a FDA 510(k) cleared general hospital medical device. Manufacturer: CHISON Medical Technologies Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k202619/ 2021-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k202619-kardiflex-ptca-balloon-dilatation-fda-510k.jpg K202619 - KardiFlex PTCA Balloon Dilatation Catheter K202619 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medcaptain Life Science Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k202987/ 2021-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k202987-rescue-pulmonary-grasping-forceps-fda-510k.jpg K202987 - Rescue Pulmonary Grasping Forceps K202987 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Anrei Medical (Hangzhou) Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k203454/ 2021-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k203454-infrared-thermometer-fda-510k.jpg K203454 - Infrared Thermometer K203454 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shandong Zhushi Pharmaceutical Group Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k210605/ 2021-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k210605-3m-bair-hugger-universal-warming-gown-fda-510k.jpg K210605 - 3M Bair Hugger Universal Warming Gown made with Thinsulate Insulation K210605 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: 3M Company. Cleared Apr 2021. https://www.510kdatabase.net/k210944/ 2021-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k210944-powder-free-nitrile-examination-glove-fda-510k.jpg K210944 - Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue) K210944 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Harbour Health, LLC. Cleared Apr 2021. https://www.510kdatabase.net/k210981/ 2021-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k210981-pure-vu-system-fda-510k.jpg K210981 - Pure Vu System K210981 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Motus GI Medical Technologies , Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k200391/ 2021-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k200391-mpact-extension-fda-510k.jpg K200391 - MPACT Extension K200391 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Apr 2021. https://www.510kdatabase.net/k202757/ 2021-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k202757-contec08a-electronic-sphygmomanometer-fda-510k.jpg K202757 - CONTEC08A Electronic Sphygmomanometer, CONTEC08C Electronic Sphygmomanometer, ABPM50 Automatic Blood Pressure Monitor K202757 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Contec Medical Systems Co.,Ltd. Cleared Apr 2021. https://www.510kdatabase.net/k203277/ 2021-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k203277-electrosurgical-generator-esg-410-foot-fda-510k.jpg K203277 - Electrosurgical Generator ESG-410, Foot Switches, PK Cutting Forceps K203277 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Olympus Winter & Ibe GmbH. Cleared Apr 2021. https://www.510kdatabase.net/k203436/ 2021-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k203436-disposable-nitrile-examination-gloves-fda-510k.jpg K203436 - Disposable Nitrile Examination Gloves K203436 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shandong Zhushi Pharmaceutical Group Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k203451/ 2021-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k203451-tcl3-motion-tracking-system-fda-510k.jpg K203451 - TCL3 Motion Tracking System K203451 is a FDA 510(k) cleared radiology medical device. Manufacturer: Tracinnovations Aps. Cleared Apr 2021. https://www.510kdatabase.net/k203532/ 2021-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k203532-bi-mentum-altrx-dual-mobility-liner-fda-510k.jpg K203532 - BI-MENTUM™ ALTRX® Dual Mobility Liner K203532 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Ireland UC. Cleared Apr 2021. https://www.510kdatabase.net/k203535/ 2021-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k203535-trinias-fda-510k.jpg K203535 - Trinias K203535 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shimadzu Corporation Medical Systems. Cleared Apr 2021. https://www.510kdatabase.net/k210020/ 2021-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k210020-medical-mask-fda-510k.jpg K210020 - Medical Mask K210020 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zhende Medical Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k210242/ 2021-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k210242-astroglide-x-silicone-personal-lubricant-fda-510k.jpg K210242 - Astroglide X Silicone Personal Lubricant K210242 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Biofilm, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k210278/ 2021-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k210278-titan-sgs-fda-510k.jpg K210278 - Titan SGS K210278 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Standard Bariatrics. Cleared Apr 2021. https://www.510kdatabase.net/k210601/ 2021-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k210601-plato-17-microcatheter-fda-510k.jpg K210601 - Plato 17 Microcatheter K210601 is a FDA 510(k) cleared neurology medical device. Manufacturer: Scientia Vascular, LLC. Cleared Apr 2021. https://www.510kdatabase.net/k210621/ 2021-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k210621-oralenteral-syringe-fda-510k.jpg K210621 - Oral/Enteral Syringe K210621 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ningbo Tianyi Medical Appliance Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k210925/ 2021-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k210925-flexiva-pulse-laser-fiber-flexiva-fda-510k.jpg K210925 - Flexiva Pulse Laser Fiber, Flexiva Pulse Tractip Laser Fiber, Flexiva Pulse ID Laser Fiber, Flexiva Pulse ID TracTip Laser Fiber K210925 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific. Cleared Apr 2021. https://www.510kdatabase.net/k210982/ 2021-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k210982-amx-navigate-fda-510k.jpg K210982 - AMX Navigate K210982 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems, LLC. Cleared Apr 2021. https://www.510kdatabase.net/k210985/ 2021-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k210985-1717fcc-fda-510k.jpg K210985 - 1717FCC K210985 is a FDA 510(k) cleared radiology medical device. Manufacturer: Rayence Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k191951/ 2021-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k191951-avazzia-otc-tens-for-aesthetics-model-fda-510k.jpg K191951 - Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device K191951 is a FDA 510(k) cleared neurology medical device. Manufacturer: Avazzia, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k203098/ 2021-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k203098-starband-starlight-st-louis-band-fda-510k.jpg K203098 - STARband, STARlight, St. Louis Band K203098 is a FDA 510(k) cleared neurology medical device. Manufacturer: Orthomerica Products, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k203121/ 2021-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k203121-responsive-arthroscopy-thunderbolt-fda-510k.jpg K203121 - Responsive Arthroscopy Thunderbolt System K203121 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Responsive Arthroscopy, LLC. Cleared Apr 2021. https://www.510kdatabase.net/k203240/ 2021-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k203240-accelx-abutments-fda-510k.jpg K203240 - AccelX Abutments K203240 is a FDA 510(k) cleared dental medical device. Manufacturer: Integrated Dental Systems, LLC. Cleared Apr 2021. https://www.510kdatabase.net/k210609/ 2021-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k210609-aquasplash-polymacon-soft-hydrophilic-fda-510k.jpg K210609 - AQUASPLASH (Polymacon) Soft (Hydrophilic) Daily Wear Contact Lens K210609 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Vp Optics. Cleared Apr 2021. https://www.510kdatabase.net/k210660/ 2021-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k210660-stone-retrieval-balloon-catheter-fda-510k.jpg K210660 - Stone Retrieval Balloon Catheter K210660 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Anrei Medical (Hangzhou) Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k210964/ 2021-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k210964-resonic-rapid-acoustic-pulse-device-fda-510k.jpg K210964 - Resonic Rapid Acoustic Pulse Device K210964 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Soliton, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k211072/ 2021-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k211072-safety-trocar-cannula-fda-510k.jpg K211072 - Safety Trocar Cannula K211072 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Apr 2021. https://www.510kdatabase.net/k193070/ 2021-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k193070-vivace-electrosurgical-device-fda-510k.jpg K193070 - VIVACE Electrosurgical Device K193070 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: ShenB Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k200260/ 2021-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k200260-percuflex-ureteral-stent-system-fda-510k.jpg K200260 - Percuflex Ureteral Stent System, Percuflex Ureteral Stent System Kit, Percuflex Nephroureteral Stent System, Amplatz Anchor Catheter System K200260 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Apr 2021. https://www.510kdatabase.net/k202258/ 2021-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k202258-erise-laser-handpiece-fda-510k.jpg K202258 - ERISE Laser handpiece K202258 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: El.En Electronic Engineering Spa. Cleared Apr 2021. https://www.510kdatabase.net/k202464/ 2021-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k202464-vital-sign-monitoring-sensor-model-xk300-fda-510k.jpg K202464 - Vital Sign Monitoring Sensor (Model :XK300) K202464 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Xandar Kardian, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k202647/ 2021-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k202647-surgical-mask-fda-510k.jpg K202647 - Surgical Mask K202647 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ningbo Green Textile Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k203264/ 2021-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k203264-microdose-injector-fda-510k.jpg K203264 - MicroDose Injector K203264 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Medone Surgical, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k203512/ 2021-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k203512-powder-free-blue-nitrile-examination-fda-510k.jpg K203512 - Powder Free Blue Nitrile Examination Glove K203512 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Vip Glove Sdn Bhd. Cleared Apr 2021. https://www.510kdatabase.net/k210347/ 2021-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k210347-vsp-system-fda-510k.jpg K210347 - VSP System K210347 is a FDA 510(k) cleared dental medical device. Manufacturer: 3D Systems. Cleared Apr 2021. https://www.510kdatabase.net/k210663/ 2021-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k210663-dermatological-diode-laser-systems-fda-510k.jpg K210663 - Dermatological Diode Laser Systems K210663 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Beijing HuaCheng Taike Technology Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k210918/ 2021-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k210918-da-vinci-fluorescence-imaging-vision-fda-510k.jpg K210918 - da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System K210918 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k211010/ 2021-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k211010-illusion-aligners-fda-510k.jpg K211010 - Illusion Aligners K211010 is a FDA 510(k) cleared dental medical device. Manufacturer: Laxmi Dental Exports Pvt, Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k192190/ 2021-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k192190-solax-electric-scooter-fda-510k.jpg K192190 - Solax Electric Scooter K192190 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Dongguan Prestige Sporting Goods Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k201853/ 2021-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k201853-naton-disposable-surgical-face-mask-fda-510k.jpg K201853 - Naton Disposable Surgical Face Mask K201853 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Naton Biotechnology (Beijing) Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k202043/ 2021-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k202043-secret-duo-fda-510k.jpg K202043 - Secret Duo K202043 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ilooda Co,., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k202257/ 2021-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k202257-dermatological-diode-laser-systems-fda-510k.jpg K202257 - Dermatological Diode Laser Systems K202257 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Zhuolu Jontelaser Manufacturing Technology Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k202387/ 2021-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k202387-disposable-surgical-face-mask-fda-510k.jpg K202387 - Disposable Surgical Face Mask K202387 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guangdong Bida Medical Technology Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k202462/ 2021-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k202462-sigma-sterilization-pouch-and-roll-fda-510k.jpg K202462 - SIGMA Sterilization Pouch and Roll K202462 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sigma Medical Supplies Corporation. Cleared Apr 2021. https://www.510kdatabase.net/k202607/ 2021-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k202607-surgical-mask-level-3-blue-50-pcs-fda-510k.jpg K202607 - Surgical Mask - Level 3 - Blue - 50 pcs, Surgical Mask - Level 3 - White - 50 pcs, Procedure Mask - Level 3 - Blue - 50 pcs, Procedure Mask - Level 3 - White - 50 pcs K202607 is a FDA 510(k) cleared general hospital medical device. Manufacturer: String King Lacrosse, LLC. Cleared Apr 2021. https://www.510kdatabase.net/k202915/ 2021-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k202915-iris-thermocoagulator-and-digital-fda-510k.jpg K202915 - IRIS Thermocoagulator and Digital Colposcope K202915 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Liger Medical, LLC. Cleared Apr 2021. https://www.510kdatabase.net/k203314/ 2021-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k203314-cartesion-prime-pcd-1000a3-v108-fda-510k.jpg K203314 - Cartesion Prime (PCD-1000A/3) V10.8 K203314 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Apr 2021. https://www.510kdatabase.net/k203502/ 2021-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k203502-medo-thyroid-fda-510k.jpg K203502 - MEDO-Thyroid K203502 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medo DX Pte. , Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k203605/ 2021-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k203605-steritrak-fda-510k.jpg K203605 - SteriTrak K203605 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arbutus Medical, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k203735/ 2021-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k203735-brainsway-deep-tms-system-fda-510k.jpg K203735 - Brainsway Deep TMS System K203735 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainsway , Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k203835/ 2021-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k203835-mis-solution-fda-510k.jpg K203835 - MIS Solution K203835 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Next Science, LLC. Cleared Apr 2021. https://www.510kdatabase.net/k203854/ 2021-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k203854-pulse-oximeter-fda-510k.jpg K203854 - Pulse Oximeter K203854 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Hexin Zondan Medical Equipment Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k210007/ 2021-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k210007-face-mask-fda-510k.jpg K210007 - Face Mask K210007 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jinhua Jingdi Medical Supplies Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k210030/ 2021-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k210030-medical-surgical-mask-fda-510k.jpg K210030 - Medical Surgical Mask K210030 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Tianjin Aoshang Outdoor Equipment Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k210312/ 2021-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k210312-plutox-digital-intraoral-x-ray-imaging-fda-510k.jpg K210312 - PlutoX Digital Intraoral X-Ray Imaging System K210312 is a FDA 510(k) cleared radiology medical device. Manufacturer: Iray Technology Taicang , Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k210345/ 2021-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k210345-2mp-monochrome-lcd-monitor-ms-s200-fda-510k.jpg K210345 - 2MP Monochrome LCD Monitor MS-S200 K210345 is a FDA 510(k) cleared radiology medical device. Manufacturer: Jvckenwood Corporation. Cleared Apr 2021. https://www.510kdatabase.net/k210626/ 2021-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k210626-saber-035-percutaneous-transluminal-fda-510k.jpg K210626 - SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter K210626 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corporation. Cleared Apr 2021. https://www.510kdatabase.net/k210885/ 2021-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k210885-dayspring-fda-510k.jpg K210885 - Dayspring K210885 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Koya Medical, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k210890/ 2021-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k210890-gps-cervical-spacers-fda-510k.jpg K210890 - GPS Cervical Spacers K210890 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: G Surgical, LLC. Cleared Apr 2021. https://www.510kdatabase.net/k210996/ 2021-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k210996-zoom-71-55-45-35-reperfusion-catheters-fda-510k.jpg K210996 - ZOOM (71, 55, 45, 35) Reperfusion Catheters K210996 is a FDA 510(k) cleared neurology medical device. Manufacturer: Imperative Care, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k211190/ 2021-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k211190-3m-clarity-aligners-3m-clarity-fda-510k.jpg K211190 - 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex) K211190 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company, Unitek Orthodontic Products. Cleared Apr 2021. https://www.510kdatabase.net/den200046/ 2021-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/den200046-neurolutions-upper-extremity-fda-510k.jpg DEN200046 - Neurolutions Upper Extremity Rehabilitation System DEN200046 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Neurolutions, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k200329/ 2021-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k200329-idcam-dental-implants-fda-510k.jpg K200329 - IDCAM Dental Implants K200329 is a FDA 510(k) cleared dental medical device. Manufacturer: Implants Diffusion International. Cleared Apr 2021. https://www.510kdatabase.net/k202480/ 2021-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k202480-nitronox-plus-0-70-nitronox-0-50-fda-510k.jpg K202480 - Nitronox Plus 0-70, Nitronox 0-50, Nitronox Plus 50/50 K202480 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Parker Hannifin. Cleared Apr 2021. https://www.510kdatabase.net/k203353/ 2021-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k203353-dvt-pro-fda-510k.jpg K203353 - DVT-PRO K203353 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Daesung Maref Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k203365/ 2021-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k203365-shockwave-intravascular-lithotripsy-fda-510k.jpg K203365 - Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter K203365 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shockwave Medical, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k203570/ 2021-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k203570-mya-joy-plus-breast-pump-fda-510k.jpg K203570 - Mya Joy PLUS Breast Pump K203570 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ameda, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k203646/ 2021-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k203646-disposable-medical-face-mask-fda-510k.jpg K203646 - Disposable Medical Face Mask K203646 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guangzhou Mei YI Kang Medical Technology Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k210065/ 2021-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k210065-verifine-safety-type-insulin-pen-needle-fda-510k.jpg K210065 - Verifine Safety Type Insulin Pen Needle K210065 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Promisemed Hangzhou Meditech Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k210482/ 2021-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k210482-medline-unite-reflex-nitinol-staple-fda-510k.jpg K210482 - Medline UNITE REFLEX Nitinol Staple System K210482 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medline Industries, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k210525/ 2021-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k210525-my01-continuous-compartmental-pressure-fda-510k.jpg K210525 - MY01 Continuous Compartmental Pressure Monitor K210525 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: MY01, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k210549/ 2021-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k210549-arx-spinal-system-fda-510k.jpg K210549 - ARx Spinal System K210549 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k210893/ 2021-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k210893-restoration-anatomic-shell-fda-510k.jpg K210893 - Restoration Anatomic Shell K210893 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. Cleared Apr 2021. https://www.510kdatabase.net/k202639/ 2021-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k202639-si-mochi-fda-510k.jpg K202639 - si-Mochi K202639 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biostone, Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k202750/ 2021-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k202750-knee-fda-510k.jpg K202750 - Knee+ K202750 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Pixee Medical. Cleared Apr 2021. https://www.510kdatabase.net/k202759/ 2021-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k202759-disposable-medical-surgical-mask-fda-510k.jpg K202759 - Disposable medical surgical mask K202759 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Chongqing Coe Display Technology Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k203533/ 2021-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k203533-vassallo-gt-fda-510k.jpg K203533 - VASSALLO GT K203533 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Filmecc Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k210145/ 2021-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k210145-nitrile-glove-powder-free-blue-fda-510k.jpg K210145 - Nitrile Glove Powder Free Blue K210145 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Changzhou Universal Medical Equipment Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k210483/ 2021-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k210483-mobio-total-knee-system-fda-510k.jpg K210483 - MOBIO Total Knee System K210483 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: B-One Ortho, Corp.. Cleared Apr 2021. https://www.510kdatabase.net/k210556/ 2021-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k210556-preview-shoulder-fda-510k.jpg K210556 - Preview Shoulder K210556 is a FDA 510(k) cleared radiology medical device. Manufacturer: Genesis Software Innovations. Cleared Apr 2021. https://www.510kdatabase.net/k210580/ 2021-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k210580-innovamatrix-fs-fda-510k.jpg K210580 - InnovaMatrix FS K210580 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Triad Life Sciences, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k210851/ 2021-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k210851-dilumen-endolumenal-interventional-fda-510k.jpg K210851 - DiLumen Endolumenal Interventional Platform (DiLumen) K210851 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Lumendi, LLC. Cleared Apr 2021. https://www.510kdatabase.net/k210867/ 2021-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k210867-nuera-tight-rf-nuera-tight-rf-plus-fda-510k.jpg K210867 - NuEra Tight RF, NuEra Tight RF Plus K210867 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bios S.R.L.. Cleared Apr 2021. https://www.510kdatabase.net/k210961/ 2021-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k210961-u2-total-knee-system-xpe-tibial-insert-fda-510k.jpg K210961 - U2 Total Knee System, XPE Tibial Insert, PS PLUS K210961 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: United Orthopedic Corporation. Cleared Apr 2021. https://www.510kdatabase.net/k210988/ 2021-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k210988-yushan-x-ray-flat-panel-detector-with-fda-510k.jpg K210988 - Yushan X-Ray Flat Panel Detector with DROC K210988 is a FDA 510(k) cleared radiology medical device. Manufacturer: Innocare Optoelectronics Corp.. Cleared Apr 2021. https://www.510kdatabase.net/k201874/ 2021-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k201874-servo-u-ventilator-system-41-servo-n-fda-510k.jpg K201874 - Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1 K201874 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Maquet Critical Care AB. Cleared Apr 2021. https://www.510kdatabase.net/k203276/ 2021-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k203276-bead-block-100-300m-1ml-bead-block-300-fda-510k.jpg K203276 - Bead Block (100 - 300µm, 1ml), Bead Block (300 - 500µm, 1ml), Bead Block (500 - 700µm, 1ml), Bead Block (700 - 900µm, 1ml), Bead Block (900 - 1200µm, 1ml), Bead Block (100 - 300µm, 2ml), Bead Block (300 - 500µm, 2ml), Bead Block (500 - 700µm, 2ml), Bead Block (700 - 900µm, 2ml), Bead Block (900 - 1200µm, 2ml) K203276 is a FDA 510(k) cleared neurology medical device. Manufacturer: Biocompatibles UK Ltd (Part of Boston Scientific Corporation. Cleared Apr 2021. https://www.510kdatabase.net/k203489/ 2021-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k203489-sefria-pcp-oral-fluid-enzyme-immunoassay-fda-510k.jpg K203489 - SEFRIA PCP Oral Fluid Enzyme Immunoassay K203489 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Immunalysis Corporation. Cleared Apr 2021. https://www.510kdatabase.net/k203596/ 2021-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k203596-panthera-occlusal-appliance-fda-510k.jpg K203596 - Panthera Occlusal Appliance K203596 is a FDA 510(k) cleared dental medical device. Manufacturer: Panthera Dental, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k203610/ 2021-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k203610-automatic-anatomy-recognition-aar-fda-510k.jpg K203610 - Automatic Anatomy Recognition (AAR) K203610 is a FDA 510(k) cleared radiology medical device. Manufacturer: Quantitative Radiology Solutions, LLC. Cleared Apr 2021. https://www.510kdatabase.net/k203805/ 2021-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k203805-disposable-nitrile-examination-gloves-fda-510k.jpg K203805 - Disposable Nitrile Examination Gloves K203805 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Yanfang Medical Technology Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k210157/ 2021-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k210157-sole-medial-column-fusion-plate-fda-510k.jpg K210157 - SOLE Medial Column Fusion Plate K210157 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthofix Srl. Cleared Apr 2021. https://www.510kdatabase.net/k210427/ 2021-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k210427-must-midline-cortical-mc-screw-system-fda-510k.jpg K210427 - M.U.S.T. Midline Cortical (MC) Screw System K210427 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Apr 2021. https://www.510kdatabase.net/k210835/ 2021-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k210835-identify-fda-510k.jpg K210835 - Identify K210835 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k210839/ 2021-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k210839-soundbite-crossing-system-peripheral-14p-fda-510k.jpg K210839 - SoundBite Crossing System - Peripheral (14P) K210839 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Soundbite Medical Solutions, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k202506/ 2021-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k202506-karma-powered-wheelchair-fda-510k.jpg K202506 - Karma Powered Wheelchair K202506 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Karma Medical Products Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k203421/ 2021-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k203421-triathlon-as-1-fda-510k.jpg K203421 - Triathlon AS-1 K203421 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Conformis, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k203469/ 2021-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k203469-ai-segmentation-fda-510k.jpg K203469 - AI Segmentation K203469 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k203473/ 2021-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k203473-sozo-fda-510k.jpg K203473 - SOZO K203473 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: ImpediMed Limited. Cleared Apr 2021. https://www.510kdatabase.net/k203495/ 2021-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k203495-arthrex-swivelock-anchor-fda-510k.jpg K203495 - Arthrex SwiveLock Anchor K203495 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k203644/ 2021-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k203644-solevy-co-llc-silicone-based-personal-fda-510k.jpg K203644 - Solevy Co. LLC Silicone Based Personal Lubricant K203644 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Solevy Co., LLC. Cleared Apr 2021. https://www.510kdatabase.net/k203654/ 2021-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k203654-solevy-co-llc-water-based-personal-fda-510k.jpg K203654 - Solevy Co. LLC Water-Based Personal Lubricant K203654 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Solevy Co., LLC. Cleared Apr 2021. https://www.510kdatabase.net/k203824/ 2021-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k203824-vps-impression-material-fda-510k.jpg K203824 - VPS Impression Material K203824 is a FDA 510(k) cleared dental medical device. Manufacturer: Hygedent, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k210121/ 2021-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k210121-rosa-partial-knee-system-fda-510k.jpg K210121 - ROSA Partial Knee System K210121 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthosoft D/B/A Zimmer Cas. Cleared Apr 2021. https://www.510kdatabase.net/k210134/ 2021-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k210134-dentis-s-clean-s-line-fda-510k.jpg K210134 - Dentis s-Clean s-Line K210134 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentis Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k210420/ 2021-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k210420-goblin-and-goblin-ls-pedicle-screw-fda-510k.jpg K210420 - Goblin and Goblin LS Pedicle Screw Systems K210420 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medynus, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k200270/ 2021-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k200270-rainbow-mct-fda-510k.jpg K200270 - rainbow MCT K200270 is a FDA 510(k) cleared radiology medical device. Manufacturer: Dentium Co., Ltd (Ict Branch). Cleared Apr 2021. https://www.510kdatabase.net/k200271/ 2021-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k200271-rainbow-ct-fda-510k.jpg K200271 - rainbow CT K200271 is a FDA 510(k) cleared radiology medical device. Manufacturer: Dentium Co., Ltd (Ict Branch). Cleared Apr 2021. https://www.510kdatabase.net/k200978/ 2021-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k200978-electric-wheelchair-model-s7110-fda-510k.jpg K200978 - Electric Wheelchair (Model: S7110) K200978 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Dongguan Prestige Sporting Goods Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k201047/ 2021-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k201047-fusion-taper-system-fda-510k.jpg K201047 - Fusion Taper System K201047 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Signature Orthopaedics Pty, Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k202055/ 2021-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k202055-looper-model-zx-579s-fda-510k.jpg K202055 - Looper (Model: ZX-579S) K202055 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Heat IN A Click, LLC. Cleared Apr 2021. https://www.510kdatabase.net/k202419/ 2021-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k202419-biotech-nitrile-examination-gloves-fda-510k.jpg K202419 - BIOTECH Nitrile Examination Gloves K202419 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Tk Hitech Technology Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k203170/ 2021-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k203170-infrared-thermometer-models-dt-8806s-fda-510k.jpg K203170 - Infrared Thermometer Models: DT-8806S, DT-8807S K203170 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen Everbest Machinery Industry Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k203517/ 2021-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k203517-saige-q-fda-510k.jpg K203517 - Saige-Q K203517 is a FDA 510(k) cleared radiology medical device. Manufacturer: DeepHealth, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k203616/ 2021-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k203616-brainsway-deep-dtms-system-fda-510k.jpg K203616 - Brainsway Deep (DTMS) System K203616 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainsway , Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k210169/ 2021-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k210169-hair-growth-device-fda-510k.jpg K210169 - Hair Growth Device K210169 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Dongguan Lescolton Intelligent Electrical Appliance Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k210276/ 2021-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k210276-disposable-nitrile-gloves-fda-510k.jpg K210276 - Disposable Nitrile Gloves K210276 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Fujian Ercon Medical Management Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k210600/ 2021-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k210600-molli-fda-510k.jpg K210600 - MOLLI K210600 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Molli Surgical, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k201718/ 2021-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k201718-gd-disposable-medical-face-mask-fda-510k.jpg K201718 - GD Disposable Medical Face Mask K201718 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Guangda Medical Material Group Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k202403/ 2021-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k202403-skore-colors-flavors-skore-colors-fda-510k.jpg K202403 - SKORE (Colors & Flavors), SKORE (Colors) K202403 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ttk Healthcare Limited. Cleared Apr 2021. https://www.510kdatabase.net/k202830/ 2021-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k202830-axiostat-patch-fda-510k.jpg K202830 - Axiostat Patch K202830 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Advamedica, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k203132/ 2021-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k203132-axios-stent-and-electrocautery-fda-510k.jpg K203132 - AXIOS Stent and Electrocautery Enhanced Delivery System K203132 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Apr 2021. https://www.510kdatabase.net/k203315/ 2021-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k203315-blueprint-patient-specific-fda-510k.jpg K203315 - BLUEPRINT™ Patient Specific Instrumentation K203315 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tornier S.A.S.. Cleared Apr 2021. https://www.510kdatabase.net/k203364/ 2021-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k203364-mdpc-8127-fda-510k.jpg K203364 - MDPC-8127 K203364 is a FDA 510(k) cleared pathology medical device. Manufacturer: Barco N.V.. Cleared Apr 2021. https://www.510kdatabase.net/k203701/ 2021-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k203701-locator-overdenture-implant-system-fda-510k.jpg K203701 - Locator Overdenture Implant System K203701 is a FDA 510(k) cleared dental medical device. Manufacturer: Ivory Super Holdco Inc. / Zest Anchors, LLC. Cleared Apr 2021. https://www.510kdatabase.net/k210235/ 2021-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k210235-verrata-plus-pressure-guide-wire-fda-510k.jpg K210235 - Verrata PLUS Pressure Guide Wire K210235 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Volcano Corporation. Cleared Apr 2021. https://www.510kdatabase.net/k210338/ 2021-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k210338-edge-insulated-blade-electrode-fda-510k.jpg K210338 - Edge Insulated Blade Electrode K210338 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien, LLC. Cleared Apr 2021. https://www.510kdatabase.net/k210539/ 2021-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k210539-corelink-midline-fixation-system-fda-510k.jpg K210539 - CoreLink Midline Fixation System K210539 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corelink, LLC. Cleared Apr 2021. https://www.510kdatabase.net/k210808/ 2021-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k210808-instylla-microcatheter-12-fda-510k.jpg K210808 - Instylla Microcatheter 1.2 K210808 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Instylla, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k201127/ 2021-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k201127-defend-ear-loop-face-masks-fda-510k.jpg K201127 - DEFEND Ear-loop Face Masks K201127 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Young Dental Manufacturing Co. 1, LLC. Cleared Apr 2021. https://www.510kdatabase.net/k201138/ 2021-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k201138-amsure-single-use-saline-topical-fda-510k.jpg K201138 - AMSure® Single Use Saline Topical Solution K201138 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Amsino Medical, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k202617/ 2021-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k202617-metapex-plus-fda-510k.jpg K202617 - Metapex Plus K202617 is a FDA 510(k) cleared dental medical device. Manufacturer: Meta Biomed Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k202992/ 2021-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k202992-briefcase-rib-fractures-triage-ribfx-fda-510k.jpg K202992 - BriefCase, RIB Fractures Triage (RibFx) K202992 is a FDA 510(k) cleared radiology medical device. Manufacturer: Aidoc Medical , Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k203390/ 2021-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k203390-artimes-pro-balloon-dilatation-catheter-fda-510k.jpg K203390 - Artimes pro Balloon Dilatation Catheter K203390 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Brosmed Medical Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k203449/ 2021-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k203449-fp-visairo-niv-mask-range-fda-510k.jpg K203449 - F&P Visairo NIV Mask Range K203449 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Fisher &Paykel Healthcare , Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k210493/ 2021-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k210493-cx30n-cx30pqx-fda-510k.jpg K210493 - CX30N (CX30PQX) K210493 is a FDA 510(k) cleared radiology medical device. Manufacturer: Wide Corporation. Cleared Apr 2021. https://www.510kdatabase.net/k210752/ 2021-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k210752-hydromark-breast-biopsy-site-marker-fda-510k.jpg K210752 - HydroMARK Breast Biopsy Site Marker K210752 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Devicor Medical Products, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k210754/ 2021-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k210754-cannulated-fasteners-and-nuts-fda-510k.jpg K210754 - Cannulated Fasteners and Nuts K210754 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OsteoCentric Technologies. Cleared Apr 2021. https://www.510kdatabase.net/k202136/ 2021-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k202136-ids-cortisol-fda-510k.jpg K202136 - IDS Cortisol K202136 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Immunodiagnostic Systems , Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k202884/ 2021-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k202884-sr-1-skin-treatment-system-fda-510k.jpg K202884 - SR-1 Skin Treatment System K202884 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Avava, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k202906/ 2021-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k202906-endopilot2-fda-510k.jpg K202906 - EndoPilot2 K202906 is a FDA 510(k) cleared dental medical device. Manufacturer: Schlumbohm GmbH & Co. KG. Cleared Apr 2021. https://www.510kdatabase.net/k203500/ 2021-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k203500-retcam-envision-fda-510k.jpg K203500 - RetCam Envision K203500 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). Cleared Apr 2021. https://www.510kdatabase.net/k210088/ 2021-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k210088-1688-4k-camera-system-l11-led-light-fda-510k.jpg K210088 - 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM Laparoscopes K210088 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker. Cleared Apr 2021. https://www.510kdatabase.net/k210197/ 2021-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k210197-nfc-600-automated-portable-retinal-fda-510k.jpg K210197 - NFC-600 Automated Portable Retinal Camera K210197 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Crystalvue Medical Corporation. Cleared Apr 2021. https://www.510kdatabase.net/k210658/ 2021-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k210658-volition-plating-system-fda-510k.jpg K210658 - Volition Plating System K210658 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ortho Solutions UK , Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k210764/ 2021-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k210764-flyte-fda-510k.jpg K210764 - Flyte K210764 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Pelvital USA, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k200919/ 2021-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k200919-idys-alif-3dti-fda-510k.jpg K200919 - Idys ALIF 3DTi K200919 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Clariance. Cleared Apr 2021. https://www.510kdatabase.net/k202679/ 2021-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k202679-optional-screen-display-for-heartsee-fda-510k.jpg K202679 - Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3 K202679 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mcgovern Medical School. Cleared Apr 2021. https://www.510kdatabase.net/k203210/ 2021-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k203210-invacare-platinum-5nxg-oxygen-fda-510k.jpg K203210 - Invacare Platinum 5NXG Oxygen Concentrator K203210 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Invacare Corporation. Cleared Apr 2021. https://www.510kdatabase.net/k203751/ 2021-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k203751-omnivision-system-fda-510k.jpg K203751 - OMNIVision system K203751 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corin USA. Cleared Apr 2021. https://www.510kdatabase.net/k210087/ 2021-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k210087-athena-surgical-rmus-system-fda-510k.jpg K210087 - Athena Surgical RMUS System K210087 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Athena Surgical, LLC. Cleared Apr 2021. https://www.510kdatabase.net/k210436/ 2021-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k210436-total30-total30-for-astigmatism-fda-510k.jpg K210436 - Total30, Total30 for Astigmatism, Total30 Multifocal, Total30 Multifocal Toric, Total30 Asphere K210436 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Alcon Laboratories, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k210456/ 2021-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k210456-ligament-staple-fda-510k.jpg K210456 - Ligament Staple K210456 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Apr 2021. https://www.510kdatabase.net/k210629/ 2021-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k210629-securacath-fda-510k.jpg K210629 - SecurAcath K210629 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Interrad Medical, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k210900/ 2021-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k210900-alphenix-infx-8000cb-infx-8000cs-v92-fda-510k.jpg K210900 - Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2 K210900 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Apr 2021. https://www.510kdatabase.net/k191479/ 2021-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k191479-velocity-alpha-highspeed-surgical-fda-510k.jpg K191479 - Velocity Alpha Highspeed Surgical Drill System K191479 is a FDA 510(k) cleared neurology medical device. Manufacturer: Adeor Medical AG. Cleared Apr 2021. https://www.510kdatabase.net/k202761/ 2021-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k202761-medical-surgical-mask-non-sterile-fda-510k.jpg K202761 - Medical Surgical Mask (Non-sterile) K202761 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guangdong Goodfeeling Hygiene Material Tec Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k203012/ 2021-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k203012-surgical-mask-fda-510k.jpg K203012 - Surgical Mask K203012 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Customfab, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k210018/ 2021-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k210018-disposable-medical-mask-fda-510k.jpg K210018 - Disposable Medical Mask K210018 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Diasia Biomedical Technology Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k193630/ 2021-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k193630-hekadrill-fda-510k.jpg K193630 - hekaDrill K193630 is a FDA 510(k) cleared neurology medical device. Manufacturer: Zethon, Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k201563/ 2021-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k201563-pure-pmma-disc-fda-510k.jpg K201563 - PuRE PMMA Disc K201563 is a FDA 510(k) cleared dental medical device. Manufacturer: Quest Dental USA Corp.. Cleared Apr 2021. https://www.510kdatabase.net/k201903/ 2021-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k201903-electric-breast-pump-models-rh-228-and-fda-510k.jpg K201903 - Electric breast pump (Models: RH-228 and RH-338) K201903 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Cixi Ruihong Electric Appliance Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k202084/ 2021-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k202084-deeplook-precise-fda-510k.jpg K202084 - DeepLook PRECISE K202084 is a FDA 510(k) cleared radiology medical device. Manufacturer: Deeplook, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k202325/ 2021-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k202325-easypoint-blood-collection-plus-fda-510k.jpg K202325 - EasyPoint Blood Collection Plus K202325 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Retractable Technologies, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k202513/ 2021-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k202513-disposable-medical-face-mask-model-fm-04-fda-510k.jpg K202513 - Disposable Medical Face Mask-Model FM-04 K202513 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen Jinko Industrial Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k202748/ 2021-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k202748-enteral-feeding-catheter-fda-510k.jpg K202748 - Enteral Feeding Catheter K202748 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medcaptain Life Science Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k203000/ 2021-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k203000-keyprint-keysplint-hard-fda-510k.jpg K203000 - KeyPrint KeySplint Hard K203000 is a FDA 510(k) cleared dental medical device. Manufacturer: Mycone Dental Supply Co. Inc. (Dba Keystone Industries). Cleared Apr 2021. https://www.510kdatabase.net/k203571/ 2021-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k203571-acuity-200-fluoroxyfocon-a-rigid-gas-fda-510k.jpg K203571 - Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens K203571 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Acuity Polymers, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k203681/ 2021-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k203681-rt-elements-cranial-srs-w-cones-fda-510k.jpg K203681 - RT Elements, Cranial SRS w/ Cones, Multiple Brain Mets SRS, Cranial SRS, Spine SRS, RT QA, Dose Review K203681 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab AG. Cleared Apr 2021. https://www.510kdatabase.net/k203742/ 2021-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k203742-identiti-alif-standalone-interbody-fda-510k.jpg K203742 - IdentiTi ALIF Standalone Interbody System K203742 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k210068/ 2021-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k210068-hs50-diagnostic-ultrasound-system-hs60-fda-510k.jpg K210068 - HS50 Diagnostic Ultrasound System, HS60 Diagnostic Ultrasound System K210068 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Medison Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k210162/ 2021-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k210162-endoscope-model-ei-740ds-fda-510k.jpg K210162 - Endoscope Model EI-740D/S K210162 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fujifilm Corporation. Cleared Apr 2021. https://www.510kdatabase.net/k210418/ 2021-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k210418-hyper-focus-fda-510k.jpg K210418 - HYPER Focus K210418 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k210710/ 2021-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k210710-pentax-medical-video-duedenoscope-ed34-fda-510k.jpg K210710 - PENTAX Medical Video Duedenoscope ED34-i10T2 K210710 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Pentax of America, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/den200055/ 2021-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/den200055-gi-genius-fda-510k.jpg DEN200055 - GI Genius DEN200055 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cosmo Artificial Intelligence - Ai, Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k202134/ 2021-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k202134-well-lead-all-silicone-foley-catheter-fda-510k.jpg K202134 - Well Lead All Silicone Foley Catheter with Temperature Sensor K202134 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Well Lead Medical Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k202632/ 2021-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k202632-electric-wheelchair-s7204s7205-fda-510k.jpg K202632 - Electric wheelchair (S7204/S7205) K202632 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Dongguan Prestige Sporting Goods Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k202729/ 2021-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k202729-microlife-upper-arm-automatic-digital-fda-510k.jpg K202729 - Microlife Upper Arm Automatic Digital Blood Pressure Monitor K202729 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Microlife Intellectual Property GmbH. Cleared Apr 2021. https://www.510kdatabase.net/k202785/ 2021-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k202785-resona-r9resona-r9-expresona-r9-fda-510k.jpg K202785 - Resona R9,Resona R9 Exp,Resona R9 Pro,Resona R9S, Nuewa R9,Nuewa R9 Exp,Nuewa R9 Pro,Nuewa R9S,Resona 7,Resona 7CV,Resona 7EXP,Resona 7S, Resona 7OB,Resona 7PRO,Imagyn 7,Resona Y Diagnostic Ultrasound System K202785 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k203550/ 2021-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k203550-activsight-intraoperative-imaging-system-fda-510k.jpg K203550 - ActivSight Intraoperative Imaging System K203550 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Activ Surgical, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k210062/ 2021-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k210062-mectaplug-pe-ii-fda-510k.jpg K210062 - Mectaplug PE II K210062 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Apr 2021. https://www.510kdatabase.net/k210408/ 2021-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k210408-depuy-synthes-variable-angle-locking-fda-510k.jpg K210408 - DePuy Synthes Variable Angle Locking Patella Plating System K210408 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes USA Products, LLC. Cleared Apr 2021. https://www.510kdatabase.net/k210491/ 2021-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k210491-cw120n-fda-510k.jpg K210491 - CW120N K210491 is a FDA 510(k) cleared radiology medical device. Manufacturer: Wide Corporation. Cleared Apr 2021. https://www.510kdatabase.net/k200463/ 2021-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k200463-huber-needle-infusion-set-safety-huber-fda-510k.jpg K200463 - Huber Needle Infusion Set, Safety Huber Needle Infusion Set K200463 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Caina Medical Co.,Ltd. Cleared Apr 2021. https://www.510kdatabase.net/k203491/ 2021-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k203491-picolo-nd-yag-picosecond-laser-system-fda-510k.jpg K203491 - PicoLO Nd: YAG Picosecond Laser System K203491 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Laseroptek Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k203520/ 2021-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k203520-blustone-synergy-interbody-fusion-system-fda-510k.jpg K203520 - Blustone Synergy Interbody Fusion System K203520 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Blustone Synergy, LLC. Cleared Apr 2021. https://www.510kdatabase.net/k210106/ 2021-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k210106-nitrile-examination-gloves-fda-510k.jpg K210106 - Nitrile Examination Gloves K210106 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zhenjiang Huayang Latex Products Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k210182/ 2021-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k210182-panama-anterior-cervical-plate-acp-fda-510k.jpg K210182 - PANAMA™ Anterior Cervical Plate (ACP) System K210182 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Flospine. Cleared Apr 2021. https://www.510kdatabase.net/k210701/ 2021-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k210701-catalys-precision-laser-system-fda-510k.jpg K210701 - CATALYS Precision Laser System K210701 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Amo Manufacturing USA, LLC. Cleared Apr 2021. https://www.510kdatabase.net/k201257/ 2021-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k201257-mibo-myoboost-ems-system-mb-1000-mb-fda-510k.jpg K201257 - MI.BO. ® MyoBoost EMS System (MB-1000, MB-600, MB-400) K201257 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Arrive Systems, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k201457/ 2021-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k201457-auxein-brand-vertaux-55-mm-pedicle-fda-510k.jpg K201457 - Auxein Brand Vertaux 5.5 mm Pedicle Screw System K201457 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Auxein Medical Private Limited/71164. Cleared Apr 2021. https://www.510kdatabase.net/k202703/ 2021-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k202703-vascutek-gelsoft-plus-ers-vascular-graft-fda-510k.jpg K202703 - Vascutek Gelsoft Plus ERS Vascular Graft K202703 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vascutek, Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k203673/ 2021-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k203673-myspine-pedicle-screw-placement-guides-fda-510k.jpg K203673 - MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC and Drill Pilot Guides, and MySpine S2-Alar/Alar Iliac Guides) K203673 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Apr 2021. https://www.510kdatabase.net/k203801/ 2021-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k203801-disposable-surgical-face-mask-fda-510k.jpg K203801 - Disposable Surgical Face Mask K203801 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Anhui Jiabao Protective Equipments Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k210554/ 2021-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k210554-physica-system-fda-510k.jpg K210554 - Physica system K210554 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Lima Corporate S.P.A.. Cleared Apr 2021. https://www.510kdatabase.net/k210681/ 2021-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k210681-siteseal-sv-fda-510k.jpg K210681 - SiteSeal SV K210681 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ensite Vascular. Cleared Apr 2021. https://www.510kdatabase.net/k210685/ 2021-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k210685-acqcross-qx-integrated-transseptal-fda-510k.jpg K210685 - AcQCross Qx Integrated Transseptal Dilator/Needle K210685 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Acutus Medical, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k210716/ 2021-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k210716-carboclear-x-pedicle-screw-system-fda-510k.jpg K210716 - CarboClear X Pedicle Screw System, CarboClear X Navigated Instruments K210716 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: CarboFix Orthopedics , Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k210734/ 2021-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k210734-endovascular-dilator-and-sets-fda-510k.jpg K210734 - Endovascular Dilator and Sets K210734 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Apr 2021. https://www.510kdatabase.net/k202655/ 2021-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k202655-disposable-medical-mask-fda-510k.jpg K202655 - Disposable Medical Mask K202655 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Dongguan Runlin Medical Supplies Technology Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k203480/ 2021-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k203480-doubleflo-system-fda-510k.jpg K203480 - DOUBLEFLO system K203480 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Hemodia Sas. Cleared Apr 2021. https://www.510kdatabase.net/k203499/ 2021-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k203499-perfit-zr-st-dental-zirconia-blank-fda-510k.jpg K203499 - Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank K203499 is a FDA 510(k) cleared dental medical device. Manufacturer: Vatech Acucera, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k203567/ 2021-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k203567-oral-b-dry-mouth-oral-rinse-fda-510k.jpg K203567 - Oral-B Dry Mouth Oral Rinse K203567 is a FDA 510(k) cleared dental medical device. Manufacturer: The Procter & Gamble Company. Cleared Apr 2021. https://www.510kdatabase.net/k203623/ 2021-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k203623-stentboost-mobile-fda-510k.jpg K203623 - StentBoost Mobile K203623 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips India Limited. Cleared Apr 2021. https://www.510kdatabase.net/k210130/ 2021-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k210130-stockert-s5-system-fda-510k.jpg K210130 - Stockert S5 System K210130 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Livanova Deutschland, GmbH. Cleared Apr 2021. https://www.510kdatabase.net/k210850/ 2021-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k210850-adas-3d-fda-510k.jpg K210850 - ADAS 3D K210850 is a FDA 510(k) cleared radiology medical device. Manufacturer: Adas3D Medical S.L.. Cleared Apr 2021. https://www.510kdatabase.net/k201171/ 2021-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k201171-leoni-laser-fibers-barefiber-fda-510k.jpg K201171 - LEONI Laser Fibers: BareFiber Disposable, BareFiber Reusable and Endoprobe Disposable K201171 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Leoni Fiber Optics, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k201611/ 2021-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k201611-apex-knee-system-fda-510k.jpg K201611 - Apex Knee System K201611 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Omnilife Science. Cleared Apr 2021. https://www.510kdatabase.net/k202183/ 2021-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k202183-porcine-mineral-collagen-composite-fda-510k.jpg K202183 - Porcine Mineral Collagen Composite K202183 is a FDA 510(k) cleared dental medical device. Manufacturer: Collagen Matrix, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k202243/ 2021-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k202243-skinpen-precision-system-fda-510k.jpg K202243 - SkinPen Precision System K202243 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Crown Aesthetics. Cleared Apr 2021. https://www.510kdatabase.net/k202441/ 2021-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k202441-eclipse-ii-with-smart-noise-cancellation-fda-510k.jpg K202441 - Eclipse II with Smart Noise Cancellation K202441 is a FDA 510(k) cleared radiology medical device. Manufacturer: Carestream Health, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k202447/ 2021-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k202447-medline-orbis-surgical-gown-fda-510k.jpg K202447 - Medline Orbis Surgical Gown K202447 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k202909/ 2021-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k202909-creodent-solidex-customized-abutment-fda-510k.jpg K202909 - CreoDent Solidex Customized Abutment K202909 is a FDA 510(k) cleared dental medical device. Manufacturer: Creodent Prosthetics, Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k202928/ 2021-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k202928-dv-target-fda-510k.jpg K202928 - DV. Target K202928 is a FDA 510(k) cleared radiology medical device. Manufacturer: Deepvoxel, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k203230/ 2021-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k203230-global-shoulder-and-delta-cta-systems-fda-510k.jpg K203230 - Global Shoulder and Delta CTA systems K203230 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Lnc.. Cleared Apr 2021. https://www.510kdatabase.net/k203310/ 2021-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k203310-synecare-1000-deep-vein-thrombosis-fda-510k.jpg K203310 - SyneCare 1000 Deep Vein Thrombosis Prevention Therapy System K203310 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Jiangsu Synecoun Medical Technology Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k203472/ 2021-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k203472-kmti-hip-replacement-system-fda-510k.jpg K203472 - KMTI Hip Replacement System K203472 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Kyocera Medical Technologies, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k203767/ 2021-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k203767-pristine-long-term-hemodialysis-catheter-fda-510k.jpg K203767 - Pristine Long-Term Hemodialysis Catheter K203767 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C B Bard, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k203816/ 2021-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k203816-degen-navigated-instrumentation-fda-510k.jpg K203816 - DeGen Navigated Instrumentation K203816 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Degen Medical. Cleared Apr 2021. https://www.510kdatabase.net/k210023/ 2021-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k210023-surgical-face-mask-fda-510k.jpg K210023 - Surgical Face Mask K210023 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guangdong Winsun Personal Care Products Co.,Ltd. Cleared Apr 2021. https://www.510kdatabase.net/k210251/ 2021-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k210251-clearpath-disposable-introducer-fda-510k.jpg K210251 - ClearPath Disposable Introducer K210251 is a FDA 510(k) cleared neurology medical device. Manufacturer: Clearmind Biomedical. Cleared Apr 2021. https://www.510kdatabase.net/k210275/ 2021-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k210275-polaris-spinal-system-fda-510k.jpg K210275 - Polaris Spinal System K210275 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer Biomet Spine, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k210692/ 2021-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k210692-digitaldiagnost-fda-510k.jpg K210692 - DigitalDiagnost K210692 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Dmc GmbH. Cleared Apr 2021. https://www.510kdatabase.net/k210784/ 2021-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k210784-extended-ha-half-pins-fda-510k.jpg K210784 - Extended HA Half Pins K210784 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k202032/ 2021-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k202032-idys-llif-3dti-fda-510k.jpg K202032 - Idys LLIF 3DTi K202032 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Clariance, Sas. Cleared Apr 2021. https://www.510kdatabase.net/k202129/ 2021-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k202129-largan-db-db-color-ocufilcon-d-daily-fda-510k.jpg K202129 - Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigma, Largan DB / DB Color (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyo K202129 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Largan Medical Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k202154/ 2021-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k202154-b-capta-fda-510k.jpg K202154 - B-Capta K202154 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Livanova Deutschland, GmbH. Cleared Apr 2021. https://www.510kdatabase.net/k202206/ 2021-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k202206-amg-pmp-pediatric-fda-510k.jpg K202206 - AMG PMP Pediatric K202206 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Eurosets S.R.L. Cleared Apr 2021. https://www.510kdatabase.net/k202228/ 2021-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k202228-omron-model-bp7900-blood-pressure-fda-510k.jpg K202228 - Omron Model BP7900 Blood Pressure Monitor + EKG K202228 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Omron Healthcare, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k202365/ 2021-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k202365-pentax-medical-video-duodenoscope-ed32-fda-510k.jpg K202365 - Pentax Medical Video Duodenoscope ED32-i10 K202365 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Pentax of America, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k202768/ 2021-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k202768-kosmo-femoral-stem-fda-510k.jpg K202768 - KOSMO Femoral Stem K202768 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: B-One Ortho, Corp.. Cleared Apr 2021. https://www.510kdatabase.net/k203195/ 2021-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k203195-simpleware-scanip-medical-fda-510k.jpg K203195 - Simpleware ScanIP Medical K203195 is a FDA 510(k) cleared radiology medical device. Manufacturer: Synopsys (Northern Europe) , Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k203782/ 2021-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k203782-nanox-cart-x-ray-system-fda-510k.jpg K203782 - Nanox Cart X-ray System K203782 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nano-X Imaging , Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k203795/ 2021-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k203795-star-rf-electrode-viva-rf-electrode-fda-510k.jpg K203795 - Star RF Electrode, VIVA RF Electrode K203795 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Starmed Co., Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k210300/ 2021-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k210300-vuesonic-one-contact-lens-cleaning-fda-510k.jpg K210300 - VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System K210300 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Vuesonic, LLC. Cleared Apr 2021. https://www.510kdatabase.net/k210340/ 2021-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k210340-vantage-orian-15t-mrt-1550-v60-with-fda-510k.jpg K210340 - Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR K210340 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Apr 2021. https://www.510kdatabase.net/k210668/ 2021-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k210668-tsolution-one-total-knee-application-fda-510k.jpg K210668 - TSolution One Total Knee Application K210668 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: THINK Surgical, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/k210743/ 2021-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k210743-acuson-redwood-diagnostic-ultrasound-fda-510k.jpg K210743 - ACUSON Redwood Diagnostic Ultrasound System K210743 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 2021. https://www.510kdatabase.net/den200038/ 2021-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/den200038-gili-pro-biosensor-also-known-as-gili-fda-510k.jpg DEN200038 - Gili Pro BioSensor (also known as “Gili BioSensor System”) DEN200038 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Continuse Biometrics , Ltd.. Cleared Apr 2021. https://www.510kdatabase.net/k200502/ 2021-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k200502-myriad-particles-fda-510k.jpg K200502 - Myriad Particles K200502 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aroa Biosurgery , Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k201879/ 2021-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k201879-digital-thermometer-model-t103-t104-fda-510k.jpg K201879 - Digital Thermometer Model T103, T104 K201879 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bioland Technology, Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k202424/ 2021-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k202424-surgical-mask-models-cr02-2-cr02-fda-510k.jpg K202424 - Surgical Mask-Models CR02-2, CR02 K202424 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Foshan Xinbao Technology Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k203101/ 2021-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k203101-secure-wear-usa-surgical-face-mask-fda-510k.jpg K203101 - Secure Wear USA Surgical Face Mask K203101 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Secured Ortho Manufacturing of America, LLC. Cleared Mar 2021. https://www.510kdatabase.net/k203258/ 2021-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k203258-syngoct-lung-cad-fda-510k.jpg K203258 - syngo.CT Lung CAD K203258 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Healthcare GmbH. Cleared Mar 2021. https://www.510kdatabase.net/k203378/ 2021-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k203378-pulsehaler-fda-510k.jpg K203378 - Pulsehaler K203378 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respinova, Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k203443/ 2021-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k203443-magnetom-vida-magnetom-sola-magnetom-fda-510k.jpg K203443 - MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea K203443 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k210057/ 2021-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k210057-blue-nitrile-exam-glove-powder-free-fda-510k.jpg K210057 - Blue Nitrile Exam Glove, Powder Free K210057 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Real Star Medical Technology Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k210071/ 2021-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k210071-sis-system-version-510-fda-510k.jpg K210071 - SIS System (Version 5.1.0) K210071 is a FDA 510(k) cleared radiology medical device. Manufacturer: Surgical Information Sciences, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k210110/ 2021-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k210110-guidion-fda-510k.jpg K210110 - Guidion K210110 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Imds Operations B.V.. Cleared Mar 2021. https://www.510kdatabase.net/k210616/ 2021-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k210616-longeviti-pmma-static-cranial-implant-fda-510k.jpg K210616 - Longeviti PMMA Static Cranial Implant K210616 is a FDA 510(k) cleared neurology medical device. Manufacturer: Longeviti Neuro Solutions, LLC. Cleared Mar 2021. https://www.510kdatabase.net/k210631/ 2021-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k210631-avitusr-bone-harvester-fda-510k.jpg K210631 - Avitus(r) Bone Harvester K210631 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Avitus Orthopaedics, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k210654/ 2021-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k210654-encor-breast-biopsy-probe-with-rinse-fda-510k.jpg K210654 - EnCor Breast Biopsy Probe with Rinse Tube K210654 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Senorx, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k201001/ 2021-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k201001-modulith-slx-f2-fda-510k.jpg K201001 - Modulith SLX-F2 K201001 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Karl Storz Endoscopy America. Cleared Mar 2021. https://www.510kdatabase.net/k201896/ 2021-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k201896-ivi-n3003-surgical-face-mask-ivi-n6006-fda-510k.jpg K201896 - ivi N3003 Surgical face Mask, ivi N6006 Surgical mask K201896 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Iob Medical, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k202708/ 2021-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k202708-surgical-face-masks-fda-510k.jpg K202708 - Surgical Face Masks K202708 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Intco Medical(Hk) Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k203641/ 2021-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k203641-e-denture-pro-fda-510k.jpg K203641 - E-Denture Pro K203641 is a FDA 510(k) cleared dental medical device. Manufacturer: Envisiontec GmbH. Cleared Mar 2021. https://www.510kdatabase.net/k203836/ 2021-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k203836-bomedent-apex-locator-wismy-apex-locator-fda-510k.jpg K203836 - BOMEDENT Apex locator, WISMY Apex locator K203836 is a FDA 510(k) cleared dental medical device. Manufacturer: Changzhou Bomedent Medical Technology Co.,Ltd. Cleared Mar 2021. https://www.510kdatabase.net/k210058/ 2021-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k210058-blue-nitrile-exam-glove-powder-free-fda-510k.jpg K210058 - Blue Nitrile Exam Glove, Powder Free K210058 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Great Harvest Trading Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k210226/ 2021-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k210226-picosure-workstation-fda-510k.jpg K210226 - PicoSure Workstation K210226 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cynosure, LLC. Cleared Mar 2021. https://www.510kdatabase.net/k210308/ 2021-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k210308-empowr-porous-femur-with-hanano-fda-510k.jpg K210308 - EMPOWR Porous Femur with HAnano SurfaceTM K210308 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Encore Medical, L.P.. Cleared Mar 2021. https://www.510kdatabase.net/k210603/ 2021-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k210603-3m-bair-hugger-temperature-management-fda-510k.jpg K210603 - 3M Bair Hugger Temperature Management System (Model 675) K210603 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: 3M Company. Cleared Mar 2021. https://www.510kdatabase.net/k200601/ 2021-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k200601-lumicare-caries-diagnostic-rinse-fda-510k.jpg K200601 - LumiCare Caries Diagnostic Rinse K200601 is a FDA 510(k) cleared dental medical device. Manufacturer: GreenMark Biomedical, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k201590/ 2021-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k201590-emma-capnograph-fda-510k.jpg K201590 - EMMA Capnograph K201590 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Masimo Corporation. Cleared Mar 2021. https://www.510kdatabase.net/k202191/ 2021-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k202191-surgical-mask-fda-510k.jpg K202191 - Surgical Mask K202191 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wuhan Zonsen Medical Products Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k203505/ 2021-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k203505-doro-qr3-headrest-system-aluminum-fda-510k.jpg K203505 - DORO QR3 Headrest System (Aluminum) K203505 is a FDA 510(k) cleared neurology medical device. Manufacturer: Pro-Med Instruments GmbH. Cleared Mar 2021. https://www.510kdatabase.net/k203826/ 2021-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k203826-lasercap-family-of-lasers-300-224-120-80-fda-510k.jpg K203826 - LaserCap Family of Lasers 300, 224, 120 & 80 K203826 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Transdermal Cap, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k203827/ 2021-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k203827-remi-fda-510k.jpg K203827 - REMI K203827 is a FDA 510(k) cleared neurology medical device. Manufacturer: Epitel, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k210173/ 2021-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k210173-starguide-fda-510k.jpg K210173 - StarGuide K210173 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Mar 2021. https://www.510kdatabase.net/k203417/ 2021-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k203417-dvt-4000s-fda-510k.jpg K203417 - DVT-4000S K203417 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Daesung Maref Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k201197/ 2021-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k201197-truabutment-ds-trubase-s-fda-510k.jpg K201197 - TruAbutment DS, TruBase S K201197 is a FDA 510(k) cleared dental medical device. Manufacturer: Truabutment, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k201426/ 2021-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k201426-mycro-band-fda-510k.jpg K201426 - MyCRO Band K201426 is a FDA 510(k) cleared neurology medical device. Manufacturer: Otto Bock Healthcare LP. Cleared Mar 2021. https://www.510kdatabase.net/k201466/ 2021-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k201466-tranberg-cls-laser-applicator-fda-510k.jpg K201466 - Tranberg CLS Laser Applicator K201466 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Clinical Laserthermia Systems, AB. Cleared Mar 2021. https://www.510kdatabase.net/k201634/ 2021-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k201634-rg-3ml-medication-cartridge-fda-510k.jpg K201634 - RG 3ml Medication Cartridge K201634 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Chengdu Shifeng Medical Technology Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k201734/ 2021-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k201734-allerblock-junior-fda-510k.jpg K201734 - AllerBlock Junior K201734 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Nasaleze International, Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k201921/ 2021-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k201921-spacelabs-lifescreen-pro-analyzer-fda-510k.jpg K201921 - Spacelabs Lifescreen PRO Analyzer K201921 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Spacelabs Healthcare, Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k201957/ 2021-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k201957-a8-a9-anesthesia-system-fda-510k.jpg K201957 - A8, A9 Anesthesia System K201957 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k202547/ 2021-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k202547-surgivisio-system-fda-510k.jpg K202547 - Surgivisio system K202547 is a FDA 510(k) cleared radiology medical device. Manufacturer: Surgivisio. Cleared Mar 2021. https://www.510kdatabase.net/k202725/ 2021-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k202725-etd4000-fda-510k.jpg K202725 - ETD4000 K202725 is a FDA 510(k) cleared neurology medical device. Manufacturer: Therasigma, LLC. Cleared Mar 2021. https://www.510kdatabase.net/k202751/ 2021-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k202751-tandemheart-pump-and-escort-controller-fda-510k.jpg K202751 - TandemHeart Pump and Escort Controller K202751 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cardiacassist, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k202905/ 2021-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k202905-disposable-face-mask-fda-510k.jpg K202905 - Disposable Face Mask K202905 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Excellence Medical Supplies Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k203038/ 2021-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k203038-toro-l-interbody-fusion-system-fda-510k.jpg K203038 - Toro-L Interbody Fusion System K203038 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Integrity Implants, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k203254/ 2021-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k203254-lucent-3d-spinal-system-fda-510k.jpg K203254 - Lucent 3D Spinal System K203254 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinal Elements, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k203259/ 2021-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k203259-fairfix-adjustable-button-system-fda-510k.jpg K203259 - FairFix Adjustable Button System K203259 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Mar 2021. https://www.510kdatabase.net/k203685/ 2021-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k203685-disposable-surgical-face-mask-fda-510k.jpg K203685 - Disposable Surgical Face Mask K203685 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Xiantao Zhongyi Safety & Protection Products Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k203788/ 2021-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k203788-dermav-laser-system-fda-510k.jpg K203788 - DermaV Laser System K203788 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lutronic Corporation. Cleared Mar 2021. https://www.510kdatabase.net/k210205/ 2021-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k210205-depuy-synthes-3545-mm-variable-angle-fda-510k.jpg K210205 - DePuy Synthes 3.5/4.5 mm Variable Angle LCP Periprosthetic Proximal Femur Plating System K210205 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes USA Products, LLC. Cleared Mar 2021. https://www.510kdatabase.net/k210207/ 2021-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k210207-humeral-eccentric-reverse-metaphysis-fda-510k.jpg K210207 - Humeral Eccentric Reverse Metaphysis K210207 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Mar 2021. https://www.510kdatabase.net/k210534/ 2021-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k210534-geo-firstfuse-1st-mtp-joint-fda-510k.jpg K210534 - GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System K210534 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Gramercy Extremity Orthopedics, LLC. Cleared Mar 2021. https://www.510kdatabase.net/k210638/ 2021-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k210638-i-ed-coil-system-fda-510k.jpg K210638 - i-ED COIL System K210638 is a FDA 510(k) cleared neurology medical device. Manufacturer: Kaneka Medical America, LLC. Cleared Mar 2021. https://www.510kdatabase.net/den200019/ 2021-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/den200019-oxehealth-vital-signs-fda-510k.jpg DEN200019 - Oxehealth Vital Signs DEN200019 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Oxehealth Limited. Cleared Mar 2021. https://www.510kdatabase.net/den200050/ 2021-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/den200050-portable-neuromodulation-stimulator-pons-fda-510k.jpg DEN200050 - Portable Neuromodulation Stimulator (PoNS) DEN200050 is a FDA 510(k) cleared neurology medical device. Manufacturer: Helius Medical, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k200177/ 2021-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k200177-low-frequency-multi-function-fda-510k.jpg K200177 - Low-frequency Multi-function physiotherapy instrument K200177 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Kentro Medical Electronics Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k201376/ 2021-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k201376-anam-test-system-fda-510k.jpg K201376 - ANAM Test System K201376 is a FDA 510(k) cleared neurology medical device. Manufacturer: Vista Lifesciences, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k201878/ 2021-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k201878-st-z5-fda-510k.jpg K201878 - ST-Z5 K201878 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Z-Systems AG. Cleared Mar 2021. https://www.510kdatabase.net/k201982/ 2021-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k201982-air-compression-therapy-system-fo-3001-fda-510k.jpg K201982 - Air compression therapy system FO-3001 K201982 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Foshan Hongfeng Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k202073/ 2021-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k202073-needlesmart-professional-ns-pro-fda-510k.jpg K202073 - NeedleSmart Professional (NS Pro) K202073 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Needlesmart Limited. Cleared Mar 2021. https://www.510kdatabase.net/k202083/ 2021-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k202083-biodegradable-powder-free-nitrile-fda-510k.jpg K202083 - Biodegradable Powder Free Nitrile Examination Glove, Blue-White Color with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs K202083 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shen Wei (Usa), Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k202133/ 2021-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k202133-disposable-medical-mask-fda-510k.jpg K202133 - Disposable Medical Mask K202133 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hangzhou Qianzhiya Sanitary Products Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k202824/ 2021-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k202824-brs-procedure-face-mask-fda-510k.jpg K202824 - BRS Procedure Face Mask K202824 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Blackbriar Regulatory Services, LLC. Cleared Mar 2021. https://www.510kdatabase.net/k202944/ 2021-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k202944-nebulae-srs-laparoscopic-surgical-fda-510k.jpg K202944 - NEBULAE SRS Laparoscopic Surgical Smoke Removal System K202944 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Northgate Technologies, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k203273/ 2021-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k203273-fibroscan-family-of-products-models-fda-510k.jpg K203273 - FibroScan® Family of Products (Models: 502 Touch, 530 Compact, 430 Mini+, and 630) K203273 is a FDA 510(k) cleared radiology medical device. Manufacturer: Echosens. Cleared Mar 2021. https://www.510kdatabase.net/k203547/ 2021-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k203547-nalu-neurostimulation-system-fda-510k.jpg K203547 - Nalu Neurostimulation System K203547 is a FDA 510(k) cleared neurology medical device. Manufacturer: Boston Scientific Neuromodulation. Cleared Mar 2021. https://www.510kdatabase.net/k203776/ 2021-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k203776-surgical-masks-model-snn200640-mn112-fda-510k.jpg K203776 - Surgical Masks, Model SNN200640 & MN112 K203776 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sq Medical Supplies, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k203834/ 2021-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k203834-arthrex-patella-sutureplates-fda-510k.jpg K203834 - Arthrex Patella SuturePlates K203834 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k210333/ 2021-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k210333-diapaste-fda-510k.jpg K210333 - DiaPaste K210333 is a FDA 510(k) cleared dental medical device. Manufacturer: DiaDent Group International. Cleared Mar 2021. https://www.510kdatabase.net/k210566/ 2021-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k210566-legion-porous-cr-narrow-femoral-fda-510k.jpg K210566 - LEGION Porous CR Narrow Femoral Components K210566 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k210667/ 2021-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k210667-firebird-si-fusion-system-fda-510k.jpg K210667 - FIREBIRD SI Fusion System K210667 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthofix, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k201626/ 2021-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k201626-safety-subcutaneous-infusion-set-fda-510k.jpg K201626 - Safety Subcutaneous Infusion Set K201626 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Epic Medical Pte. , Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k202015/ 2021-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k202015-white-endoseal-mta-fda-510k.jpg K202015 - White ENDOSEAL MTA K202015 is a FDA 510(k) cleared dental medical device. Manufacturer: Maruchi. Cleared Mar 2021. https://www.510kdatabase.net/k202080/ 2021-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k202080-biodegradable-powder-free-nitroprene-fda-510k.jpg K202080 - Biodegradable Powder Free Nitroprene Examination Glove, Low Dermatitis Potential Claim, Teal-Black Color K202080 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shen Wei (Usa), Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k202453/ 2021-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k202453-safecare-multi-drug-urine-test-cup-fda-510k.jpg K202453 - SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card K202453 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Safecare Biotech (Hangzhou) Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k202650/ 2021-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k202650-medical-disposable-face-mask-non-sterile-fda-510k.jpg K202650 - Medical disposable face mask non sterile K202650 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guangdong Zhong Ling Industrial Group Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k203133/ 2021-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k203133-envizion-medical-envue-envizion-fda-510k.jpg K203133 - ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube K203133 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Envizion Medical , Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k203225/ 2021-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k203225-aquilion-one-tsx-306a3-v104-with-fda-510k.jpg K203225 - Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System K203225 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Mar 2021. https://www.510kdatabase.net/k203560/ 2021-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k203560-sterizone-vp4-test-pack-fda-510k.jpg K203560 - STERIZONE VP4 Test Pack K203560 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Tso3 Inc., Now A Part of Stryker. Cleared Mar 2021. https://www.510kdatabase.net/k203703/ 2021-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k203703-i-q-view-fda-510k.jpg K203703 - I-Q View K203703 is a FDA 510(k) cleared radiology medical device. Manufacturer: First Source, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k210498/ 2021-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k210498-betta-link-knotless-implant-system-fda-510k.jpg K210498 - Betta Link Knotless Implant System K210498 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: T.A.G. Medical Products Corporation, Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k202186/ 2021-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k202186-truerelief-device-fda-510k.jpg K202186 - TrueRelief Device K202186 is a FDA 510(k) cleared neurology medical device. Manufacturer: Truerelief. Cleared Mar 2021. https://www.510kdatabase.net/k202483/ 2021-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k202483-myhomedoc-fda-510k.jpg K202483 - MyHomeDoc K202483 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Myhomedoc , Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k202917/ 2021-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k202917-ligasure-exact-dissector-nano-coated-fda-510k.jpg K202917 - LigaSure Exact Dissector, Nano-coated K202917 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien, LLC. Cleared Mar 2021. https://www.510kdatabase.net/k203064/ 2021-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k203064-icu-health-surgical-mask-fda-510k.jpg K203064 - ICU Health Surgical Mask K203064 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Plastikon Industries. Cleared Mar 2021. https://www.510kdatabase.net/k203205/ 2021-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k203205-navigated-spine-instruments-fda-510k.jpg K203205 - Navigated Spine Instruments K203205 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Spine. Cleared Mar 2021. https://www.510kdatabase.net/k203391/ 2021-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k203391-te7te5te7-maxte5-maxte9-diagnostic-fda-510k.jpg K203391 - TE7/TE5/TE7 Max/TE5 Max/TE9 Diagnostic Ultrasound System K203391 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k203592/ 2021-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k203592-tigertriever-and-tigertriever-17-fda-510k.jpg K203592 - Tigertriever and Tigertriever 17 Revascularization Devce K203592 is a FDA 510(k) cleared neurology medical device. Manufacturer: Rapid Medical , Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k203620/ 2021-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k203620-aneroid-sphygmomanometer-fda-510k.jpg K203620 - Aneroid Sphygmomanometer K203620 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Wuxi Exanovo Medical Instrument Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k203780/ 2021-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k203780-harvester-si-sacroiliac-fixation-system-fda-510k.jpg K203780 - Harvester SI: Sacroiliac Fixation System K203780 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinus International, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k210209/ 2021-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k210209-viz-ich-fda-510k.jpg K210209 - Viz ICH K210209 is a FDA 510(k) cleared radiology medical device. Manufacturer: Viz. Ai, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k210325/ 2021-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k210325-apollo-anterior-cervical-plate-acp-fda-510k.jpg K210325 - APOLLO Anterior Cervical Plate (ACP) System K210325 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aurora Spine, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k210555/ 2021-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k210555-7d-surgical-system-drill-guide-fda-510k.jpg K210555 - 7D Surgical System - Drill Guide K210555 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 7D Surgical, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k210828/ 2021-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k210828-dionavi-denture02-fda-510k.jpg K210828 - DIOnavi-Denture02 K210828 is a FDA 510(k) cleared dental medical device. Manufacturer: Dio Corporation. Cleared Mar 2021. https://www.510kdatabase.net/k202009/ 2021-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k202009-probe-cover-jz-kbt-001-jz-kbt-002-jz-fda-510k.jpg K202009 - Probe Cover: JZ-KBT-001, JZ-KBT-002, JZ-KBT-005, JZ-KBT-007, JZ-KBT-008, JZ-KBT-009, JZ-KBT-010, JZ-KBT-015, JZ-KBT-025, JZ-KBT-026 K202009 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen Juzhong Technology Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k202492/ 2021-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k202492-ez-io-intraosseous-vascular-access-fda-510k.jpg K202492 - EZ-IO Intraosseous Vascular Access System K202492 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Teleflex Medical. Cleared Mar 2021. https://www.510kdatabase.net/k203289/ 2021-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k203289-gold-standard-diagnostics-borrelia-fda-510k.jpg K203289 - Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit K203289 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Gold Standard Diagnostics. Cleared Mar 2021. https://www.510kdatabase.net/k203292/ 2021-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k203292-gold-standard-diagnostics-borrelia-fda-510k.jpg K203292 - Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit K203292 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Gold Standard Diagnostics. Cleared Mar 2021. https://www.510kdatabase.net/k203295/ 2021-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k203295-gold-standard-diagnostics-borrelia-fda-510k.jpg K203295 - Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit K203295 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Gold Standard Diagnostics. Cleared Mar 2021. https://www.510kdatabase.net/k203296/ 2021-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k203296-gold-standard-diagnostics-borrelia-fda-510k.jpg K203296 - Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit K203296 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Gold Standard Diagnostics. Cleared Mar 2021. https://www.510kdatabase.net/k203612/ 2021-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k203612-capture-cmv-fda-510k.jpg K203612 - Capture-CMV K203612 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Immucor, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k203737/ 2021-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k203737-spark-clear-aligner-system-fda-510k.jpg K203737 - Spark Clear Aligner System K203737 is a FDA 510(k) cleared dental medical device. Manufacturer: Ormco Corporation. Cleared Mar 2021. https://www.510kdatabase.net/k203052/ 2021-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k203052-movement-and-compressions-system-the-fda-510k.jpg K203052 - Movement and Compressions System (the MAC System) K203052 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Recovery Force, LLC. Cleared Mar 2021. https://www.510kdatabase.net/k192731/ 2021-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k192731-zida-wearable-neuromodulation-system-fda-510k.jpg K192731 - ZIDA Wearable Neuromodulation System K192731 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Exodus Innovations. Cleared Mar 2021. https://www.510kdatabase.net/k201095/ 2021-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k201095-sovereign-america-surgical-face-mask-fda-510k.jpg K201095 - Sovereign America Surgical Face Mask K201095 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Homtex, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k202081/ 2021-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k202081-biodegradable-dritek-powder-free-fda-510k.jpg K202081 - Biodegradable DriTek Powder Free Nitrile Examination Glove, Low Dermatitis Potential Claim, Blue K202081 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shen Wei (Usa), Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k202379/ 2021-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k202379-invacare-aviva-storm-rx-power-chair-fda-510k.jpg K202379 - Invacare AVIVA Storm RX Power Chair K202379 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Invacare Corporation. Cleared Mar 2021. https://www.510kdatabase.net/k202628/ 2021-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k202628-disposable-medical-face-mask-fda-510k.jpg K202628 - Disposable Medical Face Mask K202628 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Qinghai Zhong Dao Win-Win Medical Protective Equipment Co.,. Cleared Mar 2021. https://www.510kdatabase.net/k202985/ 2021-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k202985-lightwalker-laser-system-family-fda-510k.jpg K202985 - LightWalker Laser System Family K202985 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Fotona D.O.O.. Cleared Mar 2021. https://www.510kdatabase.net/k203116/ 2021-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k203116-sensorx-fda-510k.jpg K203116 - SensorX K203116 is a FDA 510(k) cleared radiology medical device. Manufacturer: Durr Dental SE. Cleared Mar 2021. https://www.510kdatabase.net/k203235/ 2021-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k203235-vbrain-fda-510k.jpg K203235 - VBrain K203235 is a FDA 510(k) cleared radiology medical device. Manufacturer: Vysioneer, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k203593/ 2021-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k203593-patient-examination-gloves-fda-510k.jpg K203593 - Patient Examination Gloves K203593 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guangdong Kingfa Sci. & Tech.Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k210120/ 2021-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k210120-bonos-hv-bonos-mv-bonos-lv-fda-510k.jpg K210120 - BonOs HV, BonOs MV, BonOs LV K210120 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osartis GmbH. Cleared Mar 2021. https://www.510kdatabase.net/k210125/ 2021-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k210125-bonos-hv-genta-bonos-mv-genta-bonos-lv-fda-510k.jpg K210125 - BonOs HV Genta, BonOs MV Genta, BonOs LV Genta K210125 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osartis GmbH. Cleared Mar 2021. https://www.510kdatabase.net/k210472/ 2021-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k210472-spineart-navigation-instrument-system-fda-510k.jpg K210472 - SPINEART Navigation Instrument System K210472 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spineart. Cleared Mar 2021. https://www.510kdatabase.net/k210479/ 2021-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k210479-impact-and-x-ranger-fda-510k.jpg K210479 - IMPACT and X-Ranger K210479 is a FDA 510(k) cleared radiology medical device. Manufacturer: Minxray, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k200925/ 2021-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k200925-clarus-peel-away-introducer-sheath-fda-510k.jpg K200925 - Clarus Peel-Away Introducer Sheath K200925 is a FDA 510(k) cleared neurology medical device. Manufacturer: Clarus Medical, LLC. Cleared Mar 2021. https://www.510kdatabase.net/k201624/ 2021-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k201624-spin-care-disposable-protective-mask-fda-510k.jpg K201624 - Spin Care Disposable Protective Mask K201624 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Spintech, LLC. Cleared Mar 2021. https://www.510kdatabase.net/k201681/ 2021-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k201681-straumann-immediate-temporary-abutments-fda-510k.jpg K201681 - Straumann Immediate Temporary Abutments K201681 is a FDA 510(k) cleared dental medical device. Manufacturer: Institut Straumann AG. Cleared Mar 2021. https://www.510kdatabase.net/k202482/ 2021-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k202482-y207-electric-wheelchair-fda-510k.jpg K202482 - Y207 Electric Wheelchair K202482 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Jiangsu Intco Medical Products Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k202773/ 2021-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k202773-s-clean-sq-sl-implant-system-mini-fda-510k.jpg K202773 - s-Clean SQ-SL Implant System Mini K202773 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentis Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k202937/ 2021-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k202937-ceragem-automatic-thermal-massager-fda-510k.jpg K202937 - Ceragem Automatic Thermal Massager Model CGM-MB-1701 & CGM-MB-1702 K202937 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Ceragem Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k203186/ 2021-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k203186-dynatape-suture-fda-510k.jpg K203186 - DYNATAPE Suture K203186 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medos International SARL. Cleared Mar 2021. https://www.510kdatabase.net/k203342/ 2021-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k203342-construx-mini-ti-spacer-system-fda-510k.jpg K203342 - CONSTRUX Mini Ti Spacer System K203342 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthofix, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k203444/ 2021-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k203444-bee-ha-cage-fda-510k.jpg K203444 - BEE HA Cage K203444 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: NGMedical GmbH. Cleared Mar 2021. https://www.510kdatabase.net/k203679/ 2021-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k203679-automatic-registration-fda-510k.jpg K203679 - Automatic Registration K203679 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Brainlab AG. Cleared Mar 2021. https://www.510kdatabase.net/k210041/ 2021-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k210041-hysil-plus-impression-materials-fda-510k.jpg K210041 - HySil Plus Impression Materials K210041 is a FDA 510(k) cleared dental medical device. Manufacturer: Osstem Implant Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k210285/ 2021-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k210285-adaptable-ortho-innovations-fda-510k.jpg K210285 - Adaptable Ortho Innovations Intramedullary Nail System K210285 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Adaptable Ortho Innovations, LLC. Cleared Mar 2021. https://www.510kdatabase.net/k210286/ 2021-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k210286-cure-20-anterior-cervical-plate-acp-fda-510k.jpg K210286 - Cure 2.0 Anterior Cervical Plate (ACP) System K210286 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Meditech Spine, LLC. Cleared Mar 2021. https://www.510kdatabase.net/k210449/ 2021-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k210449-infinity-oct-system-pass-oct-spinal-fda-510k.jpg K210449 - Infinity™ OCT System, PASS OCT® Spinal System K210449 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic. Cleared Mar 2021. https://www.510kdatabase.net/k210551/ 2021-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k210551-persona-revision-knee-system-fda-510k.jpg K210551 - Persona Revision Knee System K210551 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k210584/ 2021-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k210584-sdc3-hd-information-management-system-fda-510k.jpg K210584 - SDC3 HD Information Management System with Wireless Device Control Capability K210584 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker. Cleared Mar 2021. https://www.510kdatabase.net/k202082/ 2021-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k202082-biodegradable-powder-free-nitrile-fda-510k.jpg K202082 - Biodegradable Powder Free Nitrile Examination Glove, Green-White and Orange-White Colors with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs, Fentanyl Citrate and Simulated Gastric Acid K202082 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shen Wei (Usa), Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k203083/ 2021-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k203083-magic-360-power-wheelchair-fda-510k.jpg K203083 - Magic 360 Power Wheelchair K203083 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Magic Mobility. Cleared Mar 2021. https://www.510kdatabase.net/k203361/ 2021-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k203361-prolift-wedge-expandable-spacer-system-fda-510k.jpg K203361 - ProLift Wedge Expandable Spacer System K203361 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k203428/ 2021-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k203428-ziehm-vision-rfd-fda-510k.jpg K203428 - Ziehm Vision RFD K203428 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ziehm Imaging GmbH. Cleared Mar 2021. https://www.510kdatabase.net/k203684/ 2021-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k203684-neurosign-v4-intraoperative-nerve-fda-510k.jpg K203684 - Neurosign V4 Intraoperative Nerve Monitor K203684 is a FDA 510(k) cleared neurology medical device. Manufacturer: Magstim Company, Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k210450/ 2021-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k210450-bbx-pet-scanner-fda-510k.jpg K210450 - BBX-PET Scanner K210450 is a FDA 510(k) cleared radiology medical device. Manufacturer: Prescient Imaging, LLC. Cleared Mar 2021. https://www.510kdatabase.net/den200031/ 2021-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/den200031-biofire-respiratory-panel-21-rp21-fda-510k.jpg DEN200031 - BioFire Respiratory Panel 2.1 (RP2.1) DEN200031 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Biofire Diagnostics, LLC. Cleared Mar 2021. https://www.510kdatabase.net/k201723/ 2021-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k201723-fp-optiflow-nasal-oxygen-cannula-with-fda-510k.jpg K201723 - F&P Optiflow Nasal Oxygen Cannula with CO2 Sampling K201723 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Fisher &Paykel Healthcare , Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k202086/ 2021-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k202086-biodegradable-powder-free-nitrile-fda-510k.jpg K202086 - Biodegradable Powder Free Nitrile Examination Glove, Low Dermatitis,Potential Claim, Blue, Green, Black, White, Orange, Black-White, Teal-Gray, White-Green, White-Orange, White-Blue, Blue-White, Green-White, Orange-White Colors K202086 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shen Wei (Usa), Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k202554/ 2021-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k202554-reprocessed-harmonic-ace-7-5-mm-fda-510k.jpg K202554 - Reprocessed HARMONIC ACE+ 7, 5 mm Diameter Shears with Advanced Hemostasis K202554 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker Sustainability Solutions. Cleared Mar 2021. https://www.510kdatabase.net/k203252/ 2021-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k203252-multi-unit-abutments-for-conelog-fda-510k.jpg K203252 - Multi-unit Abutments for CONELOG K203252 is a FDA 510(k) cleared dental medical device. Manufacturer: BioHorizons Implant Systems, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k210487/ 2021-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k210487-miplni-yk-244-disposable-surgical-mask-fda-510k.jpg K210487 - MIPLNI YK-244 Disposable Surgical Mask K210487 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hunan Yuankang Biological Technology Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k201698/ 2021-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k201698-medical-surgical-mask-fda-510k.jpg K201698 - Medical Surgical Mask K201698 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hangzhou Mycode Bio-Medicine Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k201924/ 2021-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k201924-single-use-surgical-mask-fda-510k.jpg K201924 - Single-Use Surgical Mask K201924 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Qiqihar Hengxin Medical Supplies, Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k202438/ 2021-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k202438-ensure-single-use-coagulation-forceps-fda-510k.jpg K202438 - Ensure Single-Use Coagulation Forceps K202438 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Micro-Tech (Nanjing) Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k203382/ 2021-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k203382-neodent-implant-system-easy-pack-fda-510k.jpg K203382 - Neodent Implant System-Easy Pack K203382 is a FDA 510(k) cleared dental medical device. Manufacturer: Jjgc Industria E Comercio DE Materiais Dentarios S.A.. Cleared Mar 2021. https://www.510kdatabase.net/k210193/ 2021-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k210193-db-composite-fda-510k.jpg K210193 - DB-Composite K210193 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Dimensional Bioceramics, LLC. Cleared Mar 2021. https://www.510kdatabase.net/k192649/ 2021-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k192649-endo-motor-fda-510k.jpg K192649 - Endo Motor K192649 is a FDA 510(k) cleared dental medical device. Manufacturer: Foshan Cicada Dental Instrument Co, Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k201410/ 2021-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k201410-venus-bracket-rose-bracket-fda-510k.jpg K201410 - VENUS Bracket, ROSE Bracket K201410 is a FDA 510(k) cleared dental medical device. Manufacturer: Gni Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k201452/ 2021-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k201452-groshong-nxt-picc-catheter-fda-510k.jpg K201452 - Groshong NXT PICC Catheter K201452 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k201617/ 2021-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k201617-tipvision-videoscope-system-tipvision-fda-510k.jpg K201617 - TipVision Videoscope System (TipVision VideoScope 0°/30° K201617 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Schoelly Fiberoptic GmbH. Cleared Mar 2021. https://www.510kdatabase.net/k202284/ 2021-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k202284-oncospace-fda-510k.jpg K202284 - Oncospace K202284 is a FDA 510(k) cleared radiology medical device. Manufacturer: Oncospace, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k203060/ 2021-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k203060-veritas-phacoemulsification-console-fda-510k.jpg K203060 - VERITAS Phacoemulsification Console, VERITAS Advanced Fluidics Pack and Advanced Infusion Pack, VERITAS Swivel Handpiece, VERITAS Advanced Foot Pedal, VERITAS Remote Control K203060 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Johnson & Johnson Surgical Vision, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k203188/ 2021-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k203188-add-fda-510k.jpg K203188 - ADD K203188 is a FDA 510(k) cleared radiology medical device. Manufacturer: H&abyz Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k203250/ 2021-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k203250-taichic-fda-510k.jpg K203250 - TaiChiC K203250 is a FDA 510(k) cleared radiology medical device. Manufacturer: Our United Corporation. Cleared Mar 2021. https://www.510kdatabase.net/k203666/ 2021-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k203666-vinyl-examination-glovesyellow-fda-510k.jpg K203666 - Vinyl Examination Gloves(Yellow) K203666 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Lutai Medical Technology Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k203697/ 2021-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k203697-bc-reflex-uni-knee-system-fda-510k.jpg K203697 - BC Reflex Uni Knee System K203697 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Bodycad Laboratories, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k203707/ 2021-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k203707-infrared-forehead-thermometer-model-fda-510k.jpg K203707 - Infrared Forehead Thermometer, Model JZK-601, JZK-602, JZK-603 K203707 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen Zhengkang Technology Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k203775/ 2021-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k203775-aic-disposable-medical-mask-fda-510k.jpg K203775 - AIC disposable medical mask K203775 is a FDA 510(k) cleared general hospital medical device. Manufacturer: The Aleen International Corporation. Cleared Mar 2021. https://www.510kdatabase.net/k203822/ 2021-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k203822-profound-ai-software-v30-fda-510k.jpg K203822 - ProFound AI Software V3.0 K203822 is a FDA 510(k) cleared radiology medical device. Manufacturer: Icad, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k210060/ 2021-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k210060-colink-mfx-implant-system-fda-510k.jpg K210060 - CoLink Mfx Implant System K210060 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: In2bones USA, LLC. Cleared Mar 2021. https://www.510kdatabase.net/k210526/ 2021-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k210526-medline-cautery-tip-cleaner-fda-510k.jpg K210526 - Medline Cautery Tip Cleaner K210526 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medline Industries, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k201892/ 2021-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k201892-ritleng-and-ritleng-pvp-fda-510k.jpg K201892 - Ritleng®+ and Ritleng®+ PVP K201892 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Fci (France Chirurgie Instrumentation) Sas. Cleared Mar 2021. https://www.510kdatabase.net/k201975/ 2021-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k201975-miha-bodytec-ii-fda-510k.jpg K201975 - miha bodytec II K201975 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Miha Bodytec GmbH. Cleared Mar 2021. https://www.510kdatabase.net/k202062/ 2021-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k202062-wheezo-wheezerate-detector-fda-510k.jpg K202062 - wheezo WheezeRate Detector K202062 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respiri Limited. Cleared Mar 2021. https://www.510kdatabase.net/k202443/ 2021-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k202443-smart-kit-basic-smart-kit-pro-fda-510k.jpg K202443 - Smart Kit Basic, Smart Kit Pro K202443 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bsl Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k202961/ 2021-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k202961-aquabeam-robotic-system-fda-510k.jpg K202961 - AquaBeam Robotic System K202961 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Procept Biorobotics, Corporation. Cleared Mar 2021. https://www.510kdatabase.net/k203614/ 2021-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k203614-monarch-bronchoscope-fda-510k.jpg K203614 - Monarch Bronchoscope K203614 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Auris Health, Inc., A Johnson and Johnson Family Company. Cleared Mar 2021. https://www.510kdatabase.net/k210078/ 2021-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k210078-stryker-procinch-adjustable-loop-device-fda-510k.jpg K210078 - Stryker ProCinch Adjustable Loop Device K210078 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Endoscopy. Cleared Mar 2021. https://www.510kdatabase.net/k210142/ 2021-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k210142-fiber-dust-fda-510k.jpg K210142 - Fiber Dust K210142 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Quanta System Spa. Cleared Mar 2021. https://www.510kdatabase.net/k210392/ 2021-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k210392-workmate-claris-system-fda-510k.jpg K210392 - WorkMate Claris System K210392 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott. Cleared Mar 2021. https://www.510kdatabase.net/k193663/ 2021-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k193663-flopump-57ml-centrifugal-pump-fda-510k.jpg K193663 - FloPump 57mL Centrifugal Pump K193663 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: International Biophysics Corporation. Cleared Mar 2021. https://www.510kdatabase.net/k201492/ 2021-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k201492-non-sterile-zirconia-block-fda-510k.jpg K201492 - Non-Sterile Zirconia Block K201492 is a FDA 510(k) cleared dental medical device. Manufacturer: Bioden Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k201809/ 2021-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k201809-ak-98-dialysis-machine-u9000-fda-510k.jpg K201809 - AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory K201809 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corportation. Cleared Mar 2021. https://www.510kdatabase.net/k201866/ 2021-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k201866-novaline-tubing-sets-for-hemodialysis-fda-510k.jpg K201866 - NovaLine Tubing Sets for Hemodialysis K201866 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Bain Medical Equipment (Guangzhou) Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k202161/ 2021-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k202161-surgical-face-mask-fda-510k.jpg K202161 - Surgical Face Mask K202161 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hunan Eexi Technology & Service Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k202411/ 2021-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k202411-surgical-mask-fda-510k.jpg K202411 - Surgical Mask K202411 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Allmed Medical Products Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k202548/ 2021-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k202548-surgical-face-mask-fda-510k.jpg K202548 - Surgical Face Mask K202548 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wanxinda (Guangzhou) Technology Product Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k202815/ 2021-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k202815-prophecy-preoperative-navigation-fda-510k.jpg K202815 - PROPHECY Preoperative Navigation Alignment System K202815 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Mar 2021. https://www.510kdatabase.net/k203065/ 2021-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k203065-lumbar-spine-truss-system-plating-fda-510k.jpg K203065 - Lumbar Spine Truss System Plating Solution (LSTS-PS) K203065 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 4Web, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k203574/ 2021-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k203574-hivox-otc-electrical-stimulator-em59-l-fda-510k.jpg K203574 - HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2 K203574 is a FDA 510(k) cleared neurology medical device. Manufacturer: Hivox Biotek, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k203606/ 2021-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k203606-serena-sleep-block-mandibular-fda-510k.jpg K203606 - Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA) K203606 is a FDA 510(k) cleared dental medical device. Manufacturer: Meris Investment Group. Cleared Mar 2021. https://www.510kdatabase.net/k210164/ 2021-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k210164-vantage-elan-15t-mrt-2020-v60-fda-510k.jpg K210164 - Vantage Elan 1.5T, MRT-2020, V6.0 K210164 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Mar 2021. https://www.510kdatabase.net/k210359/ 2021-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k210359-hexanium-tlif-fda-510k.jpg K210359 - Hexanium TLIF K210359 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinevision, S.A.S.. Cleared Mar 2021. https://www.510kdatabase.net/k201508/ 2021-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k201508-infrared-thermometer-fda-510k.jpg K201508 - Infrared Thermometer K201508 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Dongguan Prestige Sporting Goods Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k202205/ 2021-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k202205-surgical-face-mask-fda-510k.jpg K202205 - Surgical Face Mask K202205 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Micsafe Medical Technology Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k202375/ 2021-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k202375-zoll-propaq-m-fda-510k.jpg K202375 - ZOLL Propaq M K202375 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: ZOLL Medical Corporation. Cleared Mar 2021. https://www.510kdatabase.net/k202409/ 2021-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k202409-surgical-mask-fda-510k.jpg K202409 - Surgical Mask K202409 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Allmed Medical Products Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k202591/ 2021-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k202591-body-infrared-thermometer-ht-820d-fda-510k.jpg K202591 - Body Infrared Thermometer HT-820D K202591 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Dongguan Xintai Instrument Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k202710/ 2021-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k202710-disposable-medical-face-mask-fda-510k.jpg K202710 - Disposable Medical Face Mask K202710 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wanxinda (Guangzhou) Technology Product Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k202891/ 2021-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k202891-blood-pressure-monitor-fda-510k.jpg K202891 - Blood Pressure Monitor K202891 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Guangdong Transtek Medical Electronics Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k203256/ 2021-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k203256-imbio-rvlv-software-fda-510k.jpg K203256 - Imbio RV/LV Software K203256 is a FDA 510(k) cleared radiology medical device. Manufacturer: Imbio, LLC. Cleared Mar 2021. https://www.510kdatabase.net/k203518/ 2021-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k203518-quicktome-fda-510k.jpg K203518 - Quicktome K203518 is a FDA 510(k) cleared radiology medical device. Manufacturer: Omniscient Neurotechnology Pty Ltd (O8t). Cleared Mar 2021. https://www.510kdatabase.net/k203600/ 2021-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k203600-versawrap-fda-510k.jpg K203600 - VersaWrap K203600 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Alafair Biosciences, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k203618/ 2021-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k203618-neodent-easyguide-kit-cases-fda-510k.jpg K203618 - Neodent EasyGuide Kit Cases K203618 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jjgc Industria E Comercio DE Materiais Dentarios S.A.. Cleared Mar 2021. https://www.510kdatabase.net/k210181/ 2021-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k210181-nordiwell-surgical-face-mask-fda-510k.jpg K210181 - Nordiwell Surgical Face Mask K210181 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Changzhou Combat Protective Equipment Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k200660/ 2021-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k200660-compressible-limb-and-circulation-fda-510k.jpg K200660 - Compressible Limb and Circulation Therapy System K200660 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Wonjin Mulsan Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k201678/ 2021-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k201678-ice-sg-subcutaneous-electrode-arrays-fda-510k.jpg K201678 - iCE-SG Subcutaneous Electrode Arrays K201678 is a FDA 510(k) cleared neurology medical device. Manufacturer: Ice Neurosystems, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k201728/ 2021-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k201728-versalock-periprosthetic-femur-plates-fda-510k.jpg K201728 - Versalock Periprosthetic Femur Plates System-GMReis K201728 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: GM Dos Reis Industria e Comercio Ltda.. Cleared Mar 2021. https://www.510kdatabase.net/k202439/ 2021-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k202439-disposable-medical-face-mask-fda-510k.jpg K202439 - Disposable Medical Face Mask K202439 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hunan Eexi Technology & Service Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k202753/ 2021-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k202753-ihealth-wireless-no-touch-forehead-fda-510k.jpg K202753 - iHealth Wireless No-Touch Forehead Thermometer K202753 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Andon Health Co, Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k203351/ 2021-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k203351-perfit-zr-ht-dental-zirconia-blank-fda-510k.jpg K203351 - Perfit ZR HT Dental Zirconia blank K203351 is a FDA 510(k) cleared dental medical device. Manufacturer: Vatech Acucera, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k201974/ 2021-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k201974-single-use-medical-face-mask-fda-510k.jpg K201974 - Single-use medical face mask K201974 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guangdong Horigen Mother & Baby Products Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k202125/ 2021-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k202125-century-perfusion-system-fda-510k.jpg K202125 - Century Perfusion System K202125 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Century Hlm, LLC. Cleared Mar 2021. https://www.510kdatabase.net/k201581/ 2021-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k201581-cpr-band-fda-510k.jpg K201581 - CPR BAND K201581 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Credo. Cleared Mar 2021. https://www.510kdatabase.net/k210390/ 2021-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k210390-apex-3d-total-ankle-replacement-system-fda-510k.jpg K210390 - Apex 3D Total Ankle Replacement System K210390 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paragon 28, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k191441/ 2021-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k191441-air-relax-compressible-limb-sleeve-fda-510k.jpg K191441 - Air Relax, Compressible Limb Sleeve System (Model: AR-1.0, AR-2.0) K191441 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Maxstar Industrial Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k201285/ 2021-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k201285-inmode-evolve-system-with-the-tone-fda-510k.jpg K201285 - InMode Evolve System with the Tone Applicator K201285 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Inmode , Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k201420/ 2021-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k201420-republic-spine-dark-star-spinal-system-fda-510k.jpg K201420 - Republic Spine Dark Star Spinal System K201420 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Republic Spine, LLC. Cleared Mar 2021. https://www.510kdatabase.net/k201775/ 2021-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k201775-nuvision-ice-catheter-fda-510k.jpg K201775 - NuVision ICE Catheter K201775 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nuvera Medical, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k202076/ 2021-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k202076-biodegradable-powder-free-flock-lined-fda-510k.jpg K202076 - Biodegradable Powder Free Flock-Lined Nitrile Examination Glove, Black and Gray Colors K202076 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shen Wei (Usa), Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k202078/ 2021-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k202078-biodegradable-thermoplastic-elastomer-fda-510k.jpg K202078 - Biodegradable Thermoplastic Elastomer Examination (TPE) Glove K202078 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shen Wei (Usa), Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k202300/ 2021-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k202300-optellum-virtual-nodule-clinic-fda-510k.jpg K202300 - Optellum Virtual Nodule Clinic, Optellum software, Optellum platform K202300 is a FDA 510(k) cleared radiology medical device. Manufacturer: Optellum, Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k202658/ 2021-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k202658-vivid-e80-vivid-e90-vivid-e95-fda-510k.jpg K202658 - Vivid E80/ Vivid E90/ Vivid E95 K202658 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared Mar 2021. https://www.510kdatabase.net/k202693/ 2021-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k202693-neowave-pain-relief-and-recovery-fda-510k.jpg K202693 - NeoWave Pain Relief and Recovery System, Model# T16-2020 K202693 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Eva Medtec, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k202838/ 2021-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k202838-andorate-universal-endoscope-tip-guard-fda-510k.jpg K202838 - Andorate Universal Endoscope Tip Guard K202838 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ga Health Company Limited. Cleared Mar 2021. https://www.510kdatabase.net/k202913/ 2021-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k202913-neurocap-model-dec22-fda-510k.jpg K202913 - NeuroCap (Model DEC22) K202913 is a FDA 510(k) cleared neurology medical device. Manufacturer: Memory MD, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k203054/ 2021-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k203054-flexsys-fda-510k.jpg K203054 - FlexSys K203054 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Gme (German Medical Engineering) GmbH. Cleared Mar 2021. https://www.510kdatabase.net/k203146/ 2021-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k203146-akesis-galaxy-rti-fda-510k.jpg K203146 - Akesis Galaxy RTi K203146 is a FDA 510(k) cleared radiology medical device. Manufacturer: Akesis, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k203261/ 2021-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k203261-reprocessed-inquiry-steerable-fda-510k.jpg K203261 - Reprocessed Inquiry Steerable Diagnostic EP Catheter K203261 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Innovative Health, LLC. Cleared Mar 2021. https://www.510kdatabase.net/k203346/ 2021-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k203346-oec-3d-fda-510k.jpg K203346 - OEC 3D K203346 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Oec Medical Systems, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k203425/ 2021-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k203425-surgical-mask-fda-510k.jpg K203425 - Surgical Mask K203425 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bdc Dental Corporation , Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k210309/ 2021-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k210309-cios-select-va21-flat-panel-fda-510k.jpg K210309 - Cios Select (VA21) Flat Panel K210309 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k210328/ 2021-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k210328-safesept-blunt-needle-fda-510k.jpg K210328 - SafeSept Blunt Needle K210328 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Pressure Products Medical Device Manufacturing, LLC. Cleared Mar 2021. https://www.510kdatabase.net/den200006/ 2021-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/den200006-clearup-sinus-relief-fda-510k.jpg DEN200006 - ClearUP Sinus Relief DEN200006 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Tivic Health Systems, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k202018/ 2021-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k202018-hill-rom-heart-and-respiration-rate-fda-510k.jpg K202018 - Hill-Rom Heart and Respiration Rate Monitoring System: Single Sensor, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Packs, Hill-Rom Heart and Respiration Rate Monitoring System: Sensor Activation K202018 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Hill-Rom, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k202137/ 2021-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k202137-disposable-medical-mask-fda-510k.jpg K202137 - Disposable medical mask K202137 is a FDA 510(k) cleared general hospital medical device. Manufacturer: U-Play Products Corporation. Cleared Mar 2021. https://www.510kdatabase.net/k203193/ 2021-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k203193-bd-intraosseous-infusion-system-fda-510k.jpg K203193 - BD Intraosseous Infusion System K203193 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bard Access Systems, Inc(Bas)[Wholly-Owned Subsidiary of Bd]. Cleared Mar 2021. https://www.510kdatabase.net/k203323/ 2021-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k203323-vantage-galan-3t-mrt-3020-v60-with-fda-510k.jpg K203323 - Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR K203323 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Mar 2021. https://www.510kdatabase.net/k203387/ 2021-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k203387-alignrt-plus-fda-510k.jpg K203387 - AlignRT Plus K203387 is a FDA 510(k) cleared radiology medical device. Manufacturer: Vision Rt, Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k210006/ 2021-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k210006-mi-detach-fda-510k.jpg K210006 - MI DeTACH K210006 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biorep Technologies, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k210019/ 2021-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k210019-unimed-co2-mainstream-module-model-fda-510k.jpg K210019 - Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+ K210019 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Unimed Medical Supplies, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k210225/ 2021-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k210225-surgical-face-mask-fda-510k.jpg K210225 - Surgical Face Mask K210225 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Feng Chun Yuan Medical Equipment (Shenzhen) Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k210307/ 2021-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k210307-cios-select-va21-image-intensifier-fda-510k.jpg K210307 - Cios Select (VA21) Image Intensifier K210307 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k210324/ 2021-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k210324-v-mueller-cosgrove-flex-clamps-model-fda-510k.jpg K210324 - V. Mueller Cosgrove Flex Clamps, Model Number-CV1033, CV1061, CV1133, CV1161, CV1186 K210324 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Carefusion 2200, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k201674/ 2021-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k201674-cultura-collection-and-transport-system-fda-510k.jpg K201674 - Cultura Collection and Transport System K201674 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k202316/ 2021-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k202316-medical-mask-model-kkf-1a-fda-510k.jpg K202316 - Medical mask (Model: KKF-1A) K202316 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Han Zhaoqing Sporting Goods Company Limited. Cleared Mar 2021. https://www.510kdatabase.net/k202518/ 2021-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k202518-promaxo-mri-system-fda-510k.jpg K202518 - Promaxo MRI System K202518 is a FDA 510(k) cleared radiology medical device. Manufacturer: Promaxo, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k202879/ 2021-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k202879-eogas-4-endo-steritest-rrbi-fda-510k.jpg K202879 - EOGas 4 Endo-SteriTest RRBI K202879 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Andersen Sterilizers, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k203521/ 2021-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k203521-finecross-m3-fda-510k.jpg K203521 - FineCross M3 K203521 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ashitaka Factory of Terumo Corporation. Cleared Mar 2021. https://www.510kdatabase.net/k203576/ 2021-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k203576-forza-ti-spacer-system-fda-510k.jpg K203576 - FORZA Ti Spacer System K203576 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthofix, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k203764/ 2021-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k203764-tracstar-large-distal-platform-zoom-88-fda-510k.jpg K203764 - TracStar Large Distal Platform, ZOOM 88 Large Distal Platform, ZOOM 88-T Large Distal Platform K203764 is a FDA 510(k) cleared neurology medical device. Manufacturer: Imperative Care, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k203807/ 2021-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k203807-ponto-bone-anchored-hearing-system-fda-510k.jpg K203807 - Ponto Bone Anchored Hearing System, MONO Surgery Kit K203807 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Oticon Medical AB. Cleared Mar 2021. https://www.510kdatabase.net/k210043/ 2021-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k210043-loqteq-distal-lateral-femur-plate-45-fda-510k.jpg K210043 - LOQTEQ Distal Lateral Femur Plate 4.5 System K210043 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aap Implantate AG. Cleared Mar 2021. https://www.510kdatabase.net/k210262/ 2021-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k210262-biograph-vision-quadra-petct-system-fda-510k.jpg K210262 - Biograph Vision Quadra PET/CT System K210262 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k210277/ 2021-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k210277-3m-attest-rapid-readout-biological-fda-510k.jpg K210277 - 3M Attest Rapid Readout Biological Indicator, 1295 K210277 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Mar 2021. https://www.510kdatabase.net/k210280/ 2021-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k210280-geistlich-mucograft-geistlich-fda-510k.jpg K210280 - Geistlich Mucograft®, Geistlich Mucograft® Seal K210280 is a FDA 510(k) cleared dental medical device. Manufacturer: Geistlich Pharma AG. Cleared Mar 2021. https://www.510kdatabase.net/k210282/ 2021-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k210282-wirion-embolic-protection-system-fda-510k.jpg K210282 - WIRION Embolic Protection System K210282 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cardiovascular Systems, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k210293/ 2021-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k210293-atriclip-laa-exclusion-system-fda-510k.jpg K210293 - AtriClip LAA Exclusion System K210293 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: AtriCure, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k210316/ 2021-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k210316-mars-1417x-wireless-digital-flat-panel-fda-510k.jpg K210316 - Mars 1417X Wireless Digital Flat Panel Detector K210316 is a FDA 510(k) cleared radiology medical device. Manufacturer: Iray Technology Taicang , Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k201422/ 2021-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k201422-arisure-closed-system-drug-transfer-fda-510k.jpg K201422 - Arisure Closed System Drug Transfer Device (CSTD) K201422 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Yukon Medical, LLC. Cleared Mar 2021. https://www.510kdatabase.net/k201852/ 2021-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k201852-surgical-mask-model-number-ear-loop-fda-510k.jpg K201852 - Surgical Mask-Model Number: Ear Loop, Flat-Pleated K201852 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Huizhou Foryou Medical Devices Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k201965/ 2021-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k201965-sonoeye-p1-sonoeye-p1-g-sonoeye-v1-fda-510k.jpg K201965 - SonoEye P1/ SonoEye P1-G/ SonoEye V1/ SonoEye V1-G/ SonoEye G1/ SonoEye G1-G Digital Color Doppler Palm Ultrasound System K201965 is a FDA 510(k) cleared radiology medical device. Manufacturer: CHISON Medical Technologies Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k202113/ 2021-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k202113-ceragem-automatic-thermal-massager-fda-510k.jpg K202113 - Ceragem Automatic Thermal Massager, Model CGM-MB-1901 K202113 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Ceragem Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k202166/ 2021-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k202166-senhance-surgical-system-fda-510k.jpg K202166 - Senhance Surgical System K202166 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Transenterix, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k202214/ 2021-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k202214-ifm-surgical-mask-model-sm3-fda-510k.jpg K202214 - IFM Surgical Mask Model SM3 K202214 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Fssc, LLC. Cleared Mar 2021. https://www.510kdatabase.net/k202356/ 2021-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k202356-powder-free-nitrile-examination-gloves-fda-510k.jpg K202356 - Powder free Nitrile Examination Gloves (Blue, Violet Blue, White, Cobalt Blue) K202356 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Kanglongda Vietnam Protection Technology Company Limited. Cleared Mar 2021. https://www.510kdatabase.net/k202889/ 2021-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k202889-able-medical-devices-valkyrie-thoracic-fda-510k.jpg K202889 - Able Medical Devices Valkyrie Thoracic Fixation System K202889 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Jm Longyear Manufacturing, LLC D.B.A. Able Medical Devices. Cleared Mar 2021. https://www.510kdatabase.net/k203086/ 2021-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k203086-x-plo2r-fda-510k.jpg K203086 - X-PLO2R K203086 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Belluscura, LLC. Cleared Mar 2021. https://www.510kdatabase.net/k203394/ 2021-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k203394-pleuraflow-system-with-flowglide-fda-510k.jpg K203394 - PleuraFlow System with FlowGlide K203394 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Clearflow, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k203617/ 2021-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k203617-maxfov-2-fda-510k.jpg K203617 - MaxFOV 2 K203617 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems, LLC. Cleared Mar 2021. https://www.510kdatabase.net/k203653/ 2021-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k203653-mri-ppg-patient-cable-fda-510k.jpg K203653 - MRI PPG Patient Cable K203653 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ivy Biomedical Systems, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k203755/ 2021-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k203755-shoulder-system-tinbn-coating-fda-510k.jpg K203755 - Shoulder System - TiNbN Coating K203755 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Mar 2021. https://www.510kdatabase.net/k210010/ 2021-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k210010-gmk-revision-hinge-extension-tinbn-fda-510k.jpg K210010 - GMK Revision & Hinge Extension - TiNbN Coating K210010 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Mar 2021. https://www.510kdatabase.net/k210266/ 2021-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k210266-overstitch-sx-endoscopic-suturing-system-fda-510k.jpg K210266 - OverStitch Sx Endoscopic Suturing System K210266 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Apollo Endosurgery, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k210314/ 2021-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k210314-mars1717x-wireless-digital-flat-panel-fda-510k.jpg K210314 - Mars1717X Wireless Digital Flat Panel Detector K210314 is a FDA 510(k) cleared radiology medical device. Manufacturer: Iray Technology Taicang , Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k201533/ 2021-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k201533-avinent-biomimetic-coral-and-ocean-fda-510k.jpg K201533 - Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes K201533 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Avinent Implant System S.L.U.. Cleared Mar 2021. https://www.510kdatabase.net/k201927/ 2021-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k201927-getinge-gss610n-series-steam-sterilizer-fda-510k.jpg K201927 - Getinge GSS610N Series Steam Sterilizer K201927 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Maquet GmbH. Cleared Mar 2021. https://www.510kdatabase.net/k202037/ 2021-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k202037-imani-i2-fda-510k.jpg K202037 - imani i2 K202037 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Imani Co.. Cleared Mar 2021. https://www.510kdatabase.net/k202402/ 2021-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k202402-nitrile-examination-gloves-blue-violet-fda-510k.jpg K202402 - Nitrile Examination Gloves (Blue, Violet Blue, White) K202402 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Tianshuo Medical Products Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k202678/ 2021-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k202678-omni-surgical-system-fda-510k.jpg K202678 - OMNI Surgical System K202678 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Sight Sciences, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k202743/ 2021-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k202743-med-link-temp-pulse-oximeter-fda-510k.jpg K202743 - Med-Link Temp-pulse Oximeter K202743 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Med-Link Electronics Tech Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k202776/ 2021-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k202776-fingertip-pulse-oximeter-fda-510k.jpg K202776 - Fingertip pulse oximeter K202776 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Lepu Intelligent Medical Equipment Co., Ltd.. Cleared Mar 2021. https://www.510kdatabase.net/k203275/ 2021-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k203275-recon-support-catheter-fda-510k.jpg K203275 - Recon Support Catheter K203275 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k203358/ 2021-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k203358-solitaire-x-revascularization-device-fda-510k.jpg K203358 - Solitaire X Revascularization Device K203358 is a FDA 510(k) cleared neurology medical device. Manufacturer: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. Cleared Mar 2021. https://www.510kdatabase.net/k210271/ 2021-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k210271-nuvasive-modulus-alif-system-fda-510k.jpg K210271 - NuVasive Modulus ALIF System K210271 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Mar 2021. https://www.510kdatabase.net/k210550/ 2021-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k210550-valo-grand-corded-and-accessory-lenses-fda-510k.jpg K210550 - VALO Grand Corded and Accessory Lenses K210550 is a FDA 510(k) cleared dental medical device. Manufacturer: Ultradent Products, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/den200022/ 2021-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/den200022-analytic-for-hemodynamic-instability-ahi-fda-510k.jpg DEN200022 - Analytic for Hemodynamic Instability (AHI) DEN200022 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Fifth Eye, Inc.. Cleared Mar 2021. https://www.510kdatabase.net/k201644/ 2021-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k201644-qardiocore-fda-510k.jpg K201644 - QardioCore K201644 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Qardio, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k173738/ 2021-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k173738-archworx-fda-510k.jpg K173738 - Archworx K173738 is a FDA 510(k) cleared dental medical device. Manufacturer: Utah Medical Products and Services. Cleared Feb 2021. https://www.510kdatabase.net/k200567/ 2021-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k200567-asi-plethysmogrpah-analyzer-fda-510k.jpg K200567 - ASI Plethysmogrpah Analyzer K200567 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Arterial Stiffness, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k201104/ 2021-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k201104-asoaligner-fda-510k.jpg K201104 - AsoAligner K201104 is a FDA 510(k) cleared dental medical device. Manufacturer: Aso International Manila, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k201316/ 2021-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k201316-bladder-scanner-model-m3-m3-hd-m4-m4-hd-fda-510k.jpg K201316 - Bladder Scanner (Model: M3, M3-HD, M4, M4-HD) K201316 is a FDA 510(k) cleared radiology medical device. Manufacturer: Suzhou Peaksonic Medical Technology Co., Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/k201387/ 2021-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k201387-ultrafast-ultrafast-plus-ultrafast-lite-fda-510k.jpg K201387 - Ultrafast, Ultrafast Plus, Ultrafast Lite K201387 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentlight, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k201967/ 2021-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k201967-sonoeye-p2-sonoeye-v2-sonoeye-g2-fda-510k.jpg K201967 - SonoEye P2/ SonoEye V2/ SonoEye G2 Digital Color Doppler Palm Ultrasound System K201967 is a FDA 510(k) cleared radiology medical device. Manufacturer: CHISON Medical Technologies Co., Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/k201968/ 2021-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k201968-sonoeye-p3-sonoeye-v3-sono-eye-g3-fda-510k.jpg K201968 - SonoEye P3/ SonoEye V3/ Sono Eye G3 Digital Color Doppler Palm Ultrasound System K201968 is a FDA 510(k) cleared radiology medical device. Manufacturer: CHISON Medical Technologies Co., Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/k202045/ 2021-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k202045-imani-i1-fda-510k.jpg K202045 - imani i1 K202045 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Imani Co.. Cleared Feb 2021. https://www.510kdatabase.net/k202111/ 2021-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k202111-medical-infrared-forehead-thermometer-fda-510k.jpg K202111 - Medical infrared forehead thermometer K202111 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hunan Honggao Electronic Technolofy Co., Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/k202167/ 2021-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k202167-brite-tip-radianz-guiding-sheath-fda-510k.jpg K202167 - Brite Tip Radianz Guiding Sheath K202167 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corporation. Cleared Feb 2021. https://www.510kdatabase.net/k202549/ 2021-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k202549-solax-electric-scooter-model-s202261b-fda-510k.jpg K202549 - Solax Electric Scooter (Model: S202261B) K202549 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Dongguan Prestige Sporting Goods Co., Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/k202702/ 2021-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k202702-flare-single-use-surgical-laser-fiber-fda-510k.jpg K202702 - FLARE Single-Use Surgical Laser Fiber K202702 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Realton (Suzhou) Medical Technology Co., Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/k202956/ 2021-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k202956-erisma-lp-navigated-instruments-fda-510k.jpg K202956 - Erisma LP Navigated Instruments K202956 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Clariance, Sas. Cleared Feb 2021. https://www.510kdatabase.net/k203020/ 2021-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k203020-spectral-ct-fda-510k.jpg K203020 - Spectral CT K203020 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Feb 2021. https://www.510kdatabase.net/k203182/ 2021-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k203182-subtlemr-fda-510k.jpg K203182 - SubtleMR K203182 is a FDA 510(k) cleared radiology medical device. Manufacturer: Subtle Medical, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k203439/ 2021-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k203439-disposable-vinyl-examination-gloves-fda-510k.jpg K203439 - Disposable Vinyl Examination Gloves K203439 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shandong Zhushi Pharmaceutical Group Co., Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/k203510/ 2021-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k203510-ipl-hair-removal-fda-510k.jpg K203510 - IPL Hair removal K203510 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Weikai Technology Co.,Ltd. Cleared Feb 2021. https://www.510kdatabase.net/k203651/ 2021-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k203651-cuptimize-fda-510k.jpg K203651 - Cuptimize K203651 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cuptimize, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k203819/ 2021-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k203819-t2-alpha-femur-retrograde-nailing-fda-510k.jpg K203819 - T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Tibial Nailing System, T2 Femoral System, T2 Supracondylar Nail System K203819 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker GmbH. Cleared Feb 2021. https://www.510kdatabase.net/k210033/ 2021-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k210033-laser-treatment-system-model-nyx-and-fda-510k.jpg K210033 - Laser Treatment System, Model: NYX and Grace K210033 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Canadian Pioneer Medical Technology Corporation. Cleared Feb 2021. https://www.510kdatabase.net/k210268/ 2021-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k210268-ltj-screws-and-washer-fda-510k.jpg K210268 - LTJ Screws and Washer K210268 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Azurmeds, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k210323/ 2021-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k210323-indigo-aspiration-system-lightning-fda-510k.jpg K210323 - Indigo Aspiration System - Lightning Aspiration Tubing K210323 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Penumbra, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/den190022/ 2021-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/den190022-hominis-surgical-system-fda-510k.jpg DEN190022 - Hominis Surgical System DEN190022 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Momentis Surgical , Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/den200017/ 2021-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/den200017-q-collar-fda-510k.jpg DEN200017 - Q-Collar DEN200017 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Q30 Sports Science, LLC. Cleared Feb 2021. https://www.510kdatabase.net/k201142/ 2021-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k201142-tevadaptor-bag-adaptor-ll-tevadaptor-fda-510k.jpg K201142 - TEVADAPTOR Bag Adaptor LL, TEVADAPTOR Bag Adaptor LL with ULTRASITE, TEVADAPTOR Bag Adaptor SP with ULTRASITE, TEVADAPTOR IV Secondary Safety Set with ULTRASITE, TEVADAPTOR IV Secondary Safety set K201142 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Simplivia Healthcare , Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/k201436/ 2021-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k201436-vortek-single-loop-ureteral-stent-fda-510k.jpg K201436 - Vortek Single Loop Ureteral Stent K201436 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Coloplast Corp.. Cleared Feb 2021. https://www.510kdatabase.net/k201945/ 2021-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k201945-karl-storz-udel-sterilization-trays-fda-510k.jpg K201945 - KARL STORZ UDEL Sterilization Trays K201945 is a FDA 510(k) cleared general hospital medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k201969/ 2021-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k201969-sonoeye-p6-sonoeye-v6-sonoeye-g6-fda-510k.jpg K201969 - SonoEye P6/ SonoEye V6/ SonoEye G6 Digital Color Doppler Palm Ultrasound System K201969 is a FDA 510(k) cleared radiology medical device. Manufacturer: CHISON Medical Technologies Co., Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/k201971/ 2021-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k201971-sonoeye-p5-sonoeye-v5-sonoeye-g5-fda-510k.jpg K201971 - SonoEye P5/ SonoEye V5/ SonoEye G5 Digital Color Doppler Palm Ultrasound System K201971 is a FDA 510(k) cleared radiology medical device. Manufacturer: CHISON Medical Technologies Co., Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/k202240/ 2021-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k202240-disposable-surgical-maskfluid-fda-510k.jpg K202240 - Disposable Surgical Mask/Fluid Resistant Procedure Mask K202240 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Lhm Medical Technology (Hong Kong) Limited. Cleared Feb 2021. https://www.510kdatabase.net/k202420/ 2021-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k202420-infrared-forehead-thermometer-fda-510k.jpg K202420 - Infrared Forehead Thermometer K202420 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Conmo Electronic Company Limited. Cleared Feb 2021. https://www.510kdatabase.net/k202514/ 2021-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k202514-echos-family-fda-510k.jpg K202514 - EchoS Family K202514 is a FDA 510(k) cleared radiology medical device. Manufacturer: Echolight S.P.A. Cleared Feb 2021. https://www.510kdatabase.net/k202988/ 2021-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k202988-tixel-system-fda-510k.jpg K202988 - Tixel System K202988 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Novoxel , Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/k202990/ 2021-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k202990-ninesmeasure-fda-510k.jpg K202990 - NinesMeasure K202990 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nines, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k203247/ 2021-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k203247-ifuse-torq-implant-system-fda-510k.jpg K203247 - iFuse-TORQ™ Implant System K203247 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SI-BONE, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k203332/ 2021-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k203332-non-contact-infrared-body-thermometer-fda-510k.jpg K203332 - Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C K203332 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hetaida Technology Co., Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/k203477/ 2021-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k203477-classic-fda-510k.jpg K203477 - Classic K203477 is a FDA 510(k) cleared dental medical device. Manufacturer: Orthoapnea S.L.. Cleared Feb 2021. https://www.510kdatabase.net/k203524/ 2021-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k203524-surgical-masks-fda-510k.jpg K203524 - Surgical Masks K203524 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bain Medical Equipment (Guangzhou) Co., Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/k203578/ 2021-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k203578-otis-21-optical-coherence-tomography-fda-510k.jpg K203578 - OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System K203578 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Perimeter Medical Imaging Ai, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k203665/ 2021-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k203665-stop-u-model-uxv-device-fda-510k.jpg K203665 - STOP U Model UXV Device K203665 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Pollogen, Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/k210230/ 2021-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k210230-phenom-catheters-fda-510k.jpg K210230 - Phenom Catheters K210230 is a FDA 510(k) cleared neurology medical device. Manufacturer: Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular. Cleared Feb 2021. https://www.510kdatabase.net/k200734/ 2021-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k200734-sirius-pintuition-seed-sirius-fda-510k.jpg K200734 - Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit K200734 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sirius Medical Systems B.V.. Cleared Feb 2021. https://www.510kdatabase.net/k201703/ 2021-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k201703-proxeo-twist-cordless-polishing-system-fda-510k.jpg K201703 - PROXEO Twist Cordless Polishing System PL-40 H K201703 is a FDA 510(k) cleared dental medical device. Manufacturer: W&H Dentalwerk Buermoos GmbH. Cleared Feb 2021. https://www.510kdatabase.net/k201906/ 2021-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k201906-trinity-ele-plus-and-trinity-ele-plus-fda-510k.jpg K201906 - Trinity ELE Plus and Trinity ELE Plus Pro K201906 is a FDA 510(k) cleared neurology medical device. Manufacturer: Carol Cole Company Dba Nuface. Cleared Feb 2021. https://www.510kdatabase.net/k202003/ 2021-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k202003-nitrile-powder-free-examination-glove-fda-510k.jpg K202003 - Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim K202003 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Gmp Medicare Sdn. Bhd.. Cleared Feb 2021. https://www.510kdatabase.net/k202184/ 2021-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k202184-practical-navigation-surgical-guidance-fda-510k.jpg K202184 - Practical Navigation Surgical Guidance System (PNSGS) K202184 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Practical Navigation, LLC. Cleared Feb 2021. https://www.510kdatabase.net/k203255/ 2021-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k203255-4k-uhd-laparoscope-fda-510k.jpg K203255 - 4K UHD Laparoscope K203255 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Scivita Medical Technology Co., Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/k203479/ 2021-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k203479-extremilock-lateral-ankle-fusion-plates-fda-510k.jpg K203479 - ExtremiLOCK Lateral Ankle Fusion Plates K203479 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteomed. Cleared Feb 2021. https://www.510kdatabase.net/k210195/ 2021-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k210195-triever-catheters-fda-510k.jpg K210195 - Triever Catheters K210195 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inari Medical. Cleared Feb 2021. https://www.510kdatabase.net/k210202/ 2021-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k210202-biowavego-rx-fda-510k.jpg K210202 - BioWaveGO RX K210202 is a FDA 510(k) cleared neurology medical device. Manufacturer: Biowave Corporation. Cleared Feb 2021. https://www.510kdatabase.net/k210239/ 2021-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k210239-citrespline-and-citrelock-acl-implants-fda-510k.jpg K210239 - CITRESPLINE and CITRELOCK ACL Implants K210239 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Acuitive Technologies, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k200439/ 2021-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k200439-velano-ext-extension-set-fda-510k.jpg K200439 - Velano ExT Extension Set K200439 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Velano Vascular. Cleared Feb 2021. https://www.510kdatabase.net/k201501/ 2021-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k201501-veolity-fda-510k.jpg K201501 - Veolity K201501 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mevis Medical Solutions AG. Cleared Feb 2021. https://www.510kdatabase.net/k201743/ 2021-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k201743-clarifeye-r10-clarifeye-needle-fda-510k.jpg K201743 - ClarifEye R1.0, ClarifEye Needle K201743 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederlands B.V.. Cleared Feb 2021. https://www.510kdatabase.net/k201915/ 2021-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k201915-genesiszr-4y-st1100-zirconia-fda-510k.jpg K201915 - GenesisZr 4Y+ (ST1100) Zirconia K201915 is a FDA 510(k) cleared dental medical device. Manufacturer: United Dental Resources Corporation. Cleared Feb 2021. https://www.510kdatabase.net/k202048/ 2021-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k202048-cochlear-baha-6-max-sound-processor-fda-510k.jpg K202048 - Cochlear Baha 6 Max Sound Processor, Cochlear Baha Fitting Software 6, Cochlear Baha Smart App K202048 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Cochlear Americas. Cleared Feb 2021. https://www.510kdatabase.net/k202339/ 2021-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k202339-molekule-air-mini-molekule-air-mini-fda-510k.jpg K202339 - Molekule Air Mini, Molekule Air Mini + K202339 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Molekule, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k202789/ 2021-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k202789-monaco-rtp-system-fda-510k.jpg K202789 - Monaco Rtp System K202789 is a FDA 510(k) cleared radiology medical device. Manufacturer: Elekta Solutions AB. Cleared Feb 2021. https://www.510kdatabase.net/k202950/ 2021-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k202950-stitchkit-combo-fda-510k.jpg K202950 - StitchKit COMBO K202950 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Origami Surgical. Cleared Feb 2021. https://www.510kdatabase.net/k203406/ 2021-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k203406-lumify-diagnostic-ultrasound-system-fda-510k.jpg K203406 - Lumify Diagnostic Ultrasound System K203406 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Ultrasound, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k203494/ 2021-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k203494-nissha-medical-technologies-neutral-fda-510k.jpg K203494 - Nissha Medical Technologies Neutral Electrodes K203494 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Nissha Medical Technologies, Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/k203784/ 2021-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k203784-prexion3d-explorer-pro-fda-510k.jpg K203784 - PreXion3D Explorer PRO K203784 is a FDA 510(k) cleared radiology medical device. Manufacturer: Prexion Corporation. Cleared Feb 2021. https://www.510kdatabase.net/k203804/ 2021-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k203804-global-med-systems-milesman-compact-fda-510k.jpg K203804 - Global Med Systems Milesman Compact Laser K203804 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Global Med Systems SL. Cleared Feb 2021. https://www.510kdatabase.net/k210190/ 2021-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k210190-clottriever-thrombectomy-system-fda-510k.jpg K210190 - ClotTriever Thrombectomy System K210190 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Irani Medical, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k210269/ 2021-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k210269-powerdot-pd-01mt2-muscle-stimulator-fda-510k.jpg K210269 - PowerDot PD-01MT2 Muscle Stimulator K210269 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Smartmissimo Technologies Pte, Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/den200028/ 2021-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/den200028-lumenis-stellar-m22-fda-510k.jpg DEN200028 - Lumenis Stellar M22 DEN200028 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Lumenis, Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/k200062/ 2021-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k200062-foot-and-ankle-system-fda-510k.jpg K200062 - Foot and Ankle System K200062 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Leith Medical, LLC. Cleared Feb 2021. https://www.510kdatabase.net/k201652/ 2021-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k201652-cobra-os-kit-fda-510k.jpg K201652 - COBRA-OS Kit K201652 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Front Line Medical Technologies, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k201868/ 2021-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k201868-phyziofit-medical-surgical-mask-fda-510k.jpg K201868 - Phyziofit Medical Surgical Mask K201868 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wellpower Sporting Goods Co., Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/k202662/ 2021-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k202662-parcus-titanium-interference-screws-fda-510k.jpg K202662 - Parcus Titanium Interference Screws K202662 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Parcus Medical, LLC. Cleared Feb 2021. https://www.510kdatabase.net/k203493/ 2021-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k203493-mectalock-extension-fda-510k.jpg K203493 - MectaLock Extension K203493 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Feb 2021. https://www.510kdatabase.net/k203522/ 2021-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k203522-surn5-electrosurgical-argon-beam-fda-510k.jpg K203522 - Surn5 Electrosurgical Argon Beam Generator and Accessories K203522 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Surnic Corporation. Cleared Feb 2021. https://www.510kdatabase.net/k210240/ 2021-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k210240-air-compression-therapy-device-model-fda-510k.jpg K210240 - Air Compression Therapy Device, model HW6007 K210240 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Konliking Tech & Dev. Limited. Cleared Feb 2021. https://www.510kdatabase.net/k202112/ 2021-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k202112-storz-medical-duolith-sd1-t-top-tower-fda-510k.jpg K202112 - Storz Medical Duolith SD1 T-Top & Tower System with C-Actor Sepia Handpiece K202112 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Storz Medical AG. Cleared Feb 2021. https://www.510kdatabase.net/k200527/ 2021-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k200527-pjur-woman-aloe-pjur-analyse-me-water-fda-510k.jpg K200527 - pjur WOMAN Aloe, pjur analyse me! water-based, pjur BACK DOOR water-based, pjur med Moisturising glide,pjur med NATURAL glide, We-Vibe Lube made by pjur K200527 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Pjur Group Luxembourg S.A.. Cleared Feb 2021. https://www.510kdatabase.net/k200589/ 2021-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k200589-mypao-planning-report-fda-510k.jpg K200589 - MyPAO Planning Report K200589 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medacta International S.A.. Cleared Feb 2021. https://www.510kdatabase.net/k201182/ 2021-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k201182-imask-disposable-surgical-face-mask-fda-510k.jpg K201182 - iMask Disposable Surgical Face Mask K201182 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Pac-Dent, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k201274/ 2021-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k201274-ultrasonic-osteotomy-surgical-system-fda-510k.jpg K201274 - Ultrasonic Osteotomy Surgical System K201274 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smtp Technology Co., Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/k201379/ 2021-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k201379-artemis-proximal-femoral-nail-system-fda-510k.jpg K201379 - Artemis Proximal Femoral Nail System K201379 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Glw, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k201425/ 2021-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k201425-disposable-intraoperative-probe-diop8-fda-510k.jpg K201425 - Disposable Intraoperative Probe (DIOP8) K201425 is a FDA 510(k) cleared radiology medical device. Manufacturer: Huntleigh Healthcare Limited. Cleared Feb 2021. https://www.510kdatabase.net/k201680/ 2021-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k201680-nuface-mini-plus-fda-510k.jpg K201680 - NuFACE Mini Plus K201680 is a FDA 510(k) cleared neurology medical device. Manufacturer: Carole Cole Company. Cleared Feb 2021. https://www.510kdatabase.net/k201860/ 2021-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k201860-elos-accurate-hybrid-base-fda-510k.jpg K201860 - Elos Accurate Hybrid Base K201860 is a FDA 510(k) cleared dental medical device. Manufacturer: Elos Medtech Pinol A/S. Cleared Feb 2021. https://www.510kdatabase.net/k202188/ 2021-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k202188-safety-blood-collection-sets-for-fda-510k.jpg K202188 - Safety Blood Collection Sets for Single Use K202188 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/k202212/ 2021-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k202212-truplan-fda-510k.jpg K202212 - TruPlan K202212 is a FDA 510(k) cleared radiology medical device. Manufacturer: Circle Cardiovascular Imaging, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k202232/ 2021-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k202232-comprehensive-vault-reconstruction-fda-510k.jpg K202232 - Comprehensive Vault Reconstruction System K202232 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet Manufacturing Corp. Cleared Feb 2021. https://www.510kdatabase.net/k202303/ 2021-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k202303-core-e3-suctionirrigator-fda-510k.jpg K202303 - CORE E3 Suction/irrigator K202303 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Conmed Corporation. Cleared Feb 2021. https://www.510kdatabase.net/k202346/ 2021-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k202346-spin-vision-video-bronchoscope-system-fda-510k.jpg K202346 - SPiN Vision Video Bronchoscope System K202346 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Veran Medical Technologies, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k202380/ 2021-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k202380-born-pt-lif-cage-ha-fda-510k.jpg K202380 - Born PT-LIF Cage HA K202380 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spineworxx AG. Cleared Feb 2021. https://www.510kdatabase.net/k202432/ 2021-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k202432-miniload-syringe-fda-510k.jpg K202432 - MiniLoad Syringe K202432 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ocuject, LLC. Cleared Feb 2021. https://www.510kdatabase.net/k202616/ 2021-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k202616-clearcap-distal-attachment-fda-510k.jpg K202616 - ClearCap Distal Attachment K202616 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Finemedix Co., Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/k202995/ 2021-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k202995-x-ray-flat-panel-detectorscareview-fda-510k.jpg K202995 - X-ray Flat Panel Detectors/CareView 3600RF K202995 is a FDA 510(k) cleared radiology medical device. Manufacturer: Careray Digital Medical System Co., Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/k203442/ 2021-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k203442-inbrace-orthodontic-system-fda-510k.jpg K203442 - Inbrace Orthodontic System K203442 is a FDA 510(k) cleared dental medical device. Manufacturer: Swift Health Systems, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k203462/ 2021-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k203462-advanced-dental-appliance-fda-510k.jpg K203462 - Advanced Dental Appliance K203462 is a FDA 510(k) cleared dental medical device. Manufacturer: Dasoft Partners. Cleared Feb 2021. https://www.510kdatabase.net/k203488/ 2021-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k203488-emfield-fda-510k.jpg K203488 - emField K203488 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zimmer Medizinsysteme GmbH. Cleared Feb 2021. https://www.510kdatabase.net/k203754/ 2021-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k203754-eustachi-ear-pressure-relief-device-fda-510k.jpg K203754 - Eustachi Ear Pressure Relief Device K203754 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Exercore, LLC. Cleared Feb 2021. https://www.510kdatabase.net/k210155/ 2021-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k210155-duo-expandable-interbody-fusion-system-fda-510k.jpg K210155 - Duo Expandable Interbody Fusion System K210155 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spineology, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k210167/ 2021-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k210167-delta-xtend-reverse-shoulder-system-fda-510k.jpg K210167 - DELTA XTEND Reverse Shoulder System K210167 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k210192/ 2021-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k210192-alps-clavicle-plating-system-fda-510k.jpg K210192 - A.L.P.S. Clavicle Plating System K210192 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k193330/ 2021-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k193330-clue-birth-control-fda-510k.jpg K193330 - Clue Birth Control K193330 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Biowink GmbH. Cleared Feb 2021. https://www.510kdatabase.net/k201378/ 2021-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k201378-3d-accuitomo-150n-fda-510k.jpg K201378 - 3D Accuitomo 150N K201378 is a FDA 510(k) cleared radiology medical device. Manufacturer: J. Morita USA, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k201408/ 2021-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k201408-demetra-analytics-toolkit-fda-510k.jpg K201408 - Demetra Analytics Toolkit K201408 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Barco N.V.. Cleared Feb 2021. https://www.510kdatabase.net/k201412/ 2021-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k201412-bego-semados-tr-58350-fda-510k.jpg K201412 - BEGO SEMADOS Tr 58350 K201412 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bego Implant Systems GmbH & Co. KG. Cleared Feb 2021. https://www.510kdatabase.net/k201720/ 2021-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k201720-lipps-analyzer-lipps-wire-pressure-fda-510k.jpg K201720 - LiPPS Analyzer, LiPPS Wire Pressure Guide Wire K201720 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Beijing Bywave Sensing Medical Technology Co., Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/k201863/ 2021-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k201863-tumark-vision-tumark-professional-fda-510k.jpg K201863 - Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape K201863 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Somatex Medical Technologies GmbH. Cleared Feb 2021. https://www.510kdatabase.net/k202498/ 2021-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k202498-4cis-sara-spine-system-4cis-vertu-fda-510k.jpg K202498 - 4CIS SARA Spine System, 4CIS VERTU Spine System K202498 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Solco Biomedical Company India Private Limited. Cleared Feb 2021. https://www.510kdatabase.net/k202573/ 2021-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k202573-liaison-lyme-igm-liaison-lyme-igm-fda-510k.jpg K202573 - LIAISON Lyme IgM, LIAISON Lyme IgM Control Set, LIAISON Lyme Total Antibody Plus K202573 is a FDA 510(k) cleared microbiology medical device. Manufacturer: DiaSorin, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k202574/ 2021-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k202574-liaison-lyme-igg-liaison-lyme-igg-fda-510k.jpg K202574 - LIAISON Lyme IgG, LIAISON Lyme IgG Control Set, LIAISON Lyme Total Antibody Plus K202574 is a FDA 510(k) cleared microbiology medical device. Manufacturer: DiaSorin, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k202687/ 2021-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k202687-infrared-forehead-thermometer-model-fda-510k.jpg K202687 - Infrared Forehead Thermometer, Model LFR30B, LFR50, LFR60 K202687 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen Lepu Intelligent Medical Equipment Co., Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/k203426/ 2021-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k203426-surgical-face-mask-non-sterile-fda-510k.jpg K203426 - Surgical Face Mask (non-sterile) K203426 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Nantong Taiweishi Medical Technology Co., Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/k210136/ 2021-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k210136-phantommsk-hip-fda-510k.jpg K210136 - PhantomMSK Hip K210136 is a FDA 510(k) cleared radiology medical device. Manufacturer: OrthoGrid Systems, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k210137/ 2021-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k210137-esocheck-cell-collection-device-fda-510k.jpg K210137 - EsoCheck Cell Collection Device K210137 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Lucid Diagnostics, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k210329/ 2021-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k210329-green-x-18model-pht-75chs-fda-510k.jpg K210329 - Green X 18(Model : PHT-75CHS) K210329 is a FDA 510(k) cleared radiology medical device. Manufacturer: VATECH Co., Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/k202338/ 2021-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k202338-spaceflex-shoulder-fda-510k.jpg K202338 - SpaceFlex Shoulder K202338 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: G21, S.R.L.. Cleared Feb 2021. https://www.510kdatabase.net/k202401/ 2021-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k202401-powder-free-nr-latex-surgical-glove-fda-510k.jpg K202401 - Powder Free NR Latex Surgical Glove (Sterile) with Protein content labelling claims 50ug/dm2 or less per glove of extractable Protein K202401 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Eco Medi Glove Sdn. Bhd.. Cleared Feb 2021. https://www.510kdatabase.net/k203307/ 2021-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k203307-viola-fda-510k.jpg K203307 - VIOLA K203307 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vascular Graft Solutions, Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/k203399/ 2021-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k203399-fitboner-taa-fda-510k.jpg K203399 - FITBONE(R) TAA K203399 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wittenstein Intens GmbH. Cleared Feb 2021. https://www.510kdatabase.net/k210132/ 2021-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k210132-s-clean-sq-sl-implant-system-regular-fda-510k.jpg K210132 - s-Clean SQ-SL Implant System Regular K210132 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentis Co., Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/k210252/ 2021-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k210252-itotal-identity-cruciate-retaining-cr-fda-510k.jpg K210252 - iTotal Identity Cruciate Retaining (CR) Knee Replacement System, iTotal Identity Posterior Stabilizing (PS) Knee Replacement System K210252 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Conformis, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k200626/ 2021-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k200626-vesseliq-xpress-fda-510k.jpg K200626 - VesselIQ Xpress K200626 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems SCS. Cleared Feb 2021. https://www.510kdatabase.net/k201391/ 2021-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k201391-easytech-anatomical-shoulder-system-fda-510k.jpg K201391 - Easytech® Anatomical Shoulder System K201391 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Fx Shoulder USA, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k201732/ 2021-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k201732-dukal-corporation-level-3-surgical-fda-510k.jpg K201732 - Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On K201732 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Dukal Corporation. Cleared Feb 2021. https://www.510kdatabase.net/k203312/ 2021-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k203312-vitrea-software-package-vstp-001a-fda-510k.jpg K203312 - Vitrea Software Package, VSTP-001A K203312 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Feb 2021. https://www.510kdatabase.net/k203419/ 2021-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k203419-relivion-fda-510k.jpg K203419 - Relivion K203419 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neurolief , Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/k203670/ 2021-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k203670-extra-large-check-flo-introducer-fda-510k.jpg K203670 - Extra Large Check-Flo Introducer K203670 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Feb 2021. https://www.510kdatabase.net/k210035/ 2021-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k210035-zespin-si-joint-fusion-system-fda-510k.jpg K210035 - ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix Anterior Cervical Plate System, Spinema Lumbar Plate System K210035 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aegis Spine. Cleared Feb 2021. https://www.510kdatabase.net/k210114/ 2021-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k210114-rebar-micro-catheter-fda-510k.jpg K210114 - Rebar Micro Catheter K210114 is a FDA 510(k) cleared neurology medical device. Manufacturer: Micro Therapeuatics, Inc. D/B/A Ev3 Neurovascular. Cleared Feb 2021. https://www.510kdatabase.net/k210234/ 2021-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k210234-cobas-influenza-ab-rsv-nucleic-acid-fda-510k.jpg K210234 - cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System K210234 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Molecular Systems, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k210443/ 2021-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k210443-plpt-ldv-low-dead-volume-sterile-syringe-fda-510k.jpg K210443 - PLPT LDV (Low Dead Volume) Sterile Syringe K210443 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Poonglim Pharmatech, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k210444/ 2021-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k210444-ez-injec-ldv-sterile-safety-needle-fda-510k.jpg K210444 - EZ-Injec LDV Sterile Safety Needle K210444 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Poonglim Pharmatech, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k200160/ 2021-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k200160-740-safesat-fda-510k.jpg K200160 - 740 SafeSAT K200160 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Zoe Medical, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k192742/ 2021-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k192742-straumann-variobase-c-fda-510k.jpg K192742 - Straumann Variobase C K192742 is a FDA 510(k) cleared dental medical device. Manufacturer: Institut Straumann AG. Cleared Feb 2021. https://www.510kdatabase.net/k193280/ 2021-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k193280-medcad-accuplate-patient-specific-plate-fda-510k.jpg K193280 - MedCAD® AccuPlate® Patient-Specific Plate K193280 is a FDA 510(k) cleared dental medical device. Manufacturer: Medcad. Cleared Feb 2021. https://www.510kdatabase.net/k200551/ 2021-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k200551-mectalif-transforaminal-tipeek-fda-510k.jpg K200551 - MectaLIF Transforaminal TiPEEK K200551 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta Inernational SA. Cleared Feb 2021. https://www.510kdatabase.net/k201356/ 2021-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k201356-plastic-lor-syringe-fda-510k.jpg K201356 - Plastic LOR Syringe K201356 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Jiangsu Caina Medical Co.,Ltd. Cleared Feb 2021. https://www.510kdatabase.net/k201490/ 2021-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k201490-electro-flo-6-airway-clearance-system-fda-510k.jpg K201490 - Electro Flo 6 Airway Clearance System K201490 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Med Systems, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k201545/ 2021-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k201545-surgical-face-mask-fda-510k.jpg K201545 - Surgical Face Mask K201545 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Amphastar Nanjing Pharmaceuticals, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k201628/ 2021-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k201628-panda-ires-warmer-giraffe-warmer-fda-510k.jpg K201628 - Panda iRes Warmer, Giraffe Warmer K201628 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ge Healthcare. Cleared Feb 2021. https://www.510kdatabase.net/k201799/ 2021-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k201799-cleanical-fda-510k.jpg K201799 - CleaniCal K201799 is a FDA 510(k) cleared dental medical device. Manufacturer: Maruchi. Cleared Feb 2021. https://www.510kdatabase.net/k202281/ 2021-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k202281-eds-bioceramic-sealer-bioseal-fda-510k.jpg K202281 - EDS Bioceramic Sealer (Bioseal) K202281 is a FDA 510(k) cleared dental medical device. Manufacturer: Essential Dental Systems. Cleared Feb 2021. https://www.510kdatabase.net/k202341/ 2021-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k202341-disposable-surgical-mask-fda-510k.jpg K202341 - Disposable Surgical Mask K202341 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shanghai Jianzhong Medical Packaging Co., Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/k202368/ 2021-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k202368-infrared-thermometer-fda-510k.jpg K202368 - Infrared Thermometer K202368 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shandong Bittel Intelligent Technology Co., Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/k202611/ 2021-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k202611-catalyst-orthoscience-r1-reverse-fda-510k.jpg K202611 - Catalyst OrthoScience R1 Reverse Shoulder System K202611 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Catalyst Orthoscience, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k202651/ 2021-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k202651-noa-sleep-apnea-and-snoring-device-fda-510k.jpg K202651 - NOA Sleep Apnea and Snoring Device K202651 is a FDA 510(k) cleared dental medical device. Manufacturer: Orthoapnea S.L.. Cleared Feb 2021. https://www.510kdatabase.net/k203091/ 2021-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k203091-mucolock-oral-gel-fda-510k.jpg K203091 - MucoLock Oral Gel K203091 is a FDA 510(k) cleared dental medical device. Manufacturer: Pcca, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k203191/ 2021-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k203191-lydus-nitrile-examination-gloves-fda-510k.jpg K203191 - LYDUS Nitrile Examination Gloves, Powder Free K203191 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Nathan Trading Co., Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/k203355/ 2021-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k203355-straumann-tlx-novaloc-and-cementable-fda-510k.jpg K203355 - Straumann TLX Novaloc and Cementable Abutments K203355 is a FDA 510(k) cleared dental medical device. Manufacturer: Institut Straumann AG. Cleared Feb 2021. https://www.510kdatabase.net/k203546/ 2021-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k203546-gammacore-sapphire-fda-510k.jpg K203546 - gammaCore Sapphire K203546 is a FDA 510(k) cleared neurology medical device. Manufacturer: Electrocore, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k203702/ 2021-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k203702-vinyl-examination-gloves-yellow-fda-510k.jpg K203702 - Vinyl Examination Gloves (Yellow) K203702 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Xinying Trading Co., Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/k203740/ 2021-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k203740-juggerknot-soft-anchor-fda-510k.jpg K203740 - JuggerKnot Soft Anchor K203740 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Riverpoint Medical. Cleared Feb 2021. https://www.510kdatabase.net/k203766/ 2021-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k203766-4d-integrated-treatment-console-fda-510k.jpg K203766 - 4D Integrated Treatment Console K203766 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k192839/ 2021-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k192839-dsp-implant-system-fda-510k.jpg K192839 - DSP Implant System K192839 is a FDA 510(k) cleared dental medical device. Manufacturer: D.S.P Industrial Eireli. Cleared Feb 2021. https://www.510kdatabase.net/k193662/ 2021-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k193662-ezlymph-ezlymph-m-fda-510k.jpg K193662 - Ezlymph, Ezlymph M K193662 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Eezcare Medical Corp. Cleared Feb 2021. https://www.510kdatabase.net/k201222/ 2021-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k201222-bio-c-repair-ion-fda-510k.jpg K201222 - Bio-C Repair Ion+ K201222 is a FDA 510(k) cleared dental medical device. Manufacturer: Angelus Industria DE Produtos Odontologicos S/A. Cleared Feb 2021. https://www.510kdatabase.net/k201292/ 2021-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k201292-traus-sip20-fda-510k.jpg K201292 - TRAUS SIP20 K201292 is a FDA 510(k) cleared dental medical device. Manufacturer: Saeshin Precision Co., Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/k202219/ 2021-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k202219-vortran-go2vent-with-peep-valve-fda-510k.jpg K202219 - VORTRAN GO2VENT with PEEP Valve K202219 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Vortran Medical Technology 1, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k203385/ 2021-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k203385-tenotac-soft-tissue-fixation-system-fda-510k.jpg K203385 - TenoTac Soft Tissue Fixation System K203385 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paragon 28, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k210089/ 2021-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k210089-catsmart-automated-blood-processing-fda-510k.jpg K210089 - CATSmart, Automated Blood Processing Autotransfusion System K210089 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Fresenius Kabi AG. Cleared Feb 2021. https://www.510kdatabase.net/k191897/ 2021-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k191897-solax-electric-scooter-models-s3023-fda-510k.jpg K191897 - Solax Electric Scooter (Models: S3023, S3024, S3025, S3026) K191897 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Dongguan Prestige Sporting Goods Co., Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/k200675/ 2021-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k200675-hi-bebe-super-models-bt-150s-and-bt-150l-fda-510k.jpg K200675 - Hi bebe super (Models BT-150S and BT-150L) K200675 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Bistos Co., Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/k201332/ 2021-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k201332-meditech-abpm-06-bp6-fda-510k.jpg K201332 - Meditech ABPM-06 (BP6) K201332 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Meditech , Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/k201454/ 2021-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k201454-dsg-connect-technology-fda-510k.jpg K201454 - DSG Connect Technology K201454 is a FDA 510(k) cleared neurology medical device. Manufacturer: Spineguard S.A.. Cleared Feb 2021. https://www.510kdatabase.net/k201536/ 2021-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k201536-infrared-forehead-thermometer-fda-510k.jpg K201536 - Infrared Forehead Thermometer K201536 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hangzhou Qingyuan Medical Equipment Technology Co., Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/k202174/ 2021-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k202174-digital-neuroport-biopotential-signal-fda-510k.jpg K202174 - Digital NeuroPort Biopotential Signal Processing System K202174 is a FDA 510(k) cleared neurology medical device. Manufacturer: Blackrock Microsystems. Cleared Feb 2021. https://www.510kdatabase.net/k202605/ 2021-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k202605-standard-procedure-mask-standard-fda-510k.jpg K202605 - Standard Procedure Mask, Standard Surgical Mask K202605 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Medplus Non-Woven Manufacturer Co., Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/k203490/ 2021-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k203490-fore-sight-elite-absolute-tissue-fda-510k.jpg K203490 - FORE-SIGHT ELITE Absolute Tissue Oximeter K203490 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Feb 2021. https://www.510kdatabase.net/k203513/ 2021-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k203513-slendertone-evolve-abs-type-735-fda-510k.jpg K203513 - SLENDERTONE Evolve Abs, Type 735 K203513 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Bio-Medical Research, Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/k203557/ 2021-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k203557-empowr-dual-mobility-metal-liner-fda-510k.jpg K203557 - EMPOWR Dual Mobility Metal Liner, EMPOWR Dual Mobility Poly Bearing K203557 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Encore Medical, L.P.. Cleared Feb 2021. https://www.510kdatabase.net/k203632/ 2021-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k203632-da-vinci-ssi-is2000is3000-5mm-and-8mm-fda-510k.jpg K203632 - da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments K203632 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k201583/ 2021-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k201583-smartct-r10-fda-510k.jpg K201583 - SmartCT R1.0 K201583 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Feb 2021. https://www.510kdatabase.net/k202850/ 2021-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k202850-concerto-versa-detachable-coil-fda-510k.jpg K202850 - Concerto Versa, Detachable Coil K202850 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. Cleared Feb 2021. https://www.510kdatabase.net/k203055/ 2021-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k203055-stryker-peek-customized-cranial-fda-510k.jpg K203055 - Stryker PEEK Customized Cranial Implant Kit K203055 is a FDA 510(k) cleared neurology medical device. Manufacturer: Stryker. Cleared Feb 2021. https://www.510kdatabase.net/k203079/ 2021-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k203079-mr-conditional-sticky-pad-electrode-fda-510k.jpg K203079 - MR Conditional Sticky Pad Electrode K203079 is a FDA 510(k) cleared neurology medical device. Manufacturer: Rhythmlink International, LLC. Cleared Feb 2021. https://www.510kdatabase.net/k203103/ 2021-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k203103-synapse-3d-synapse-3d-base-tools-v61-fda-510k.jpg K203103 - Synapse 3D, Synapse 3D Base Tools v6.1 K203103 is a FDA 510(k) cleared radiology medical device. Manufacturer: Fujifilm Corporation. Cleared Feb 2021. https://www.510kdatabase.net/k203265/ 2021-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k203265-npro-surgical-mask-fda-510k.jpg K203265 - nPro Surgical Mask K203265 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Np Medical, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k210083/ 2021-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k210083-indigo-system-aspiration-catheter-7-fda-510k.jpg K210083 - Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7 K210083 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Penumbra, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k210272/ 2021-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k210272-liaison-anti-hav-fda-510k.jpg K210272 - LIAISON Anti-HAV K210272 is a FDA 510(k) cleared microbiology medical device. Manufacturer: DiaSorin, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k202942/ 2021-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k202942-straumann-4-mm-short-implants-fda-510k.jpg K202942 - Straumann 4 mm Short Implants K202942 is a FDA 510(k) cleared dental medical device. Manufacturer: Straumann USA, LLC. Cleared Feb 2021. https://www.510kdatabase.net/k203069/ 2021-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k203069-hydromid-fda-510k.jpg K203069 - HydroMID K203069 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Access Vascular, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k200276/ 2021-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k200276-speac-system-fda-510k.jpg K200276 - SPEAC System K200276 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brain Sentinel, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k201635/ 2021-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k201635-mouthlab-vital-signs-monitoring-system-fda-510k.jpg K201635 - MouthLab Vital Signs Monitoring System K201635 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Multisensor Diagnostics (Dba Aidar Health). Cleared Feb 2021. https://www.510kdatabase.net/k200320/ 2021-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k200320-mirus-circular-stapler-mirus-linear-fda-510k.jpg K200320 - Mirus Circular Stapler, Mirus Linear Cutter and Reload, Mirus Hemorrhoidal Circular Stapler, Mirus Linear Stapler and Reload K200320 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: M/s. Meril Endo Surgery Private Limited.. Cleared Feb 2021. https://www.510kdatabase.net/k200368/ 2021-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k200368-link-embrace-shoulder-system-reverse-fda-510k.jpg K200368 - LINK Embrace Shoulder System - Reverse Configuration K200368 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Waldemar Link GmbH & Co. KG. Cleared Feb 2021. https://www.510kdatabase.net/k200470/ 2021-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k200470-shofu-block-hc-hard-fda-510k.jpg K200470 - Shofu Block HC Hard K200470 is a FDA 510(k) cleared dental medical device. Manufacturer: Shofu Dental Corporation. Cleared Feb 2021. https://www.510kdatabase.net/k201121/ 2021-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k201121-sphincterotome-fda-510k.jpg K201121 - Sphincterotome K201121 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hangzhou AGS MedTech Co., Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/k201306/ 2021-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k201306-hamilton-c3-fda-510k.jpg K201306 - HAMILTON-C3 K201306 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Hamilton Medical AG. Cleared Feb 2021. https://www.510kdatabase.net/k201324/ 2021-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k201324-antibacterial-bandage-fda-510k.jpg K201324 - Antibacterial Bandage K201324 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Jiangsu Excellence Medical Supplies Co., Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/k201421/ 2021-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k201421-dukal-corporation-level-2-surgical-fda-510k.jpg K201421 - Dukal Corporation Level 2 Surgical Mask with Ear Loops K201421 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Dukal Corporation. Cleared Feb 2021. https://www.510kdatabase.net/k203290/ 2021-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k203290-bonelogic-fda-510k.jpg K203290 - Bonelogic K203290 is a FDA 510(k) cleared radiology medical device. Manufacturer: Disior, Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/k203302/ 2021-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k203302-gentlewave-x-fda-510k.jpg K203302 - GentleWave X K203302 is a FDA 510(k) cleared dental medical device. Manufacturer: Sonendo, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k203319/ 2021-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k203319-symphony-oct-system-fda-510k.jpg K203319 - SYMPHONY™ OCT System K203319 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International SARL. Cleared Feb 2021. https://www.510kdatabase.net/k203334/ 2021-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k203334-the-citrefix-knotless-suture-anchor-fda-510k.jpg K203334 - The Citrefix Knotless Suture Anchor K203334 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Acuitive Technologies, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k203374/ 2021-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k203374-x-mind-prime-under-trade-mark-acteon-i-fda-510k.jpg K203374 - X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology) K203374 is a FDA 510(k) cleared radiology medical device. Manufacturer: De G?tzen S.R.L.. Cleared Feb 2021. https://www.510kdatabase.net/k203475/ 2021-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k203475-limacorporate-kirschner-wire-fda-510k.jpg K203475 - LimaCorporate Kirschner Wire K203475 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Lima Corporate S.P.A.. Cleared Feb 2021. https://www.510kdatabase.net/k203588/ 2021-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k203588-eleos-limb-salvage-system-fda-510k.jpg K203588 - ELEOS™ Limb Salvage System K203588 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Onkos Surgical. Cleared Feb 2021. https://www.510kdatabase.net/k203635/ 2021-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k203635-patient-monitoring-cables-fda-510k.jpg K203635 - Patient Monitoring Cables K203635 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Jkh USA, LLC. Cleared Feb 2021. https://www.510kdatabase.net/k210036/ 2021-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k210036-carnation-ambulatory-monitor-cam-fda-510k.jpg K210036 - Carnation Ambulatory Monitor (CAM) K210036 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bardy Diagnostics, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k210053/ 2021-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k210053-lvivo-software-application-fda-510k.jpg K210053 - LVivo Software Application K210053 is a FDA 510(k) cleared radiology medical device. Manufacturer: Dia Imaging Analysis, Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/k210054/ 2021-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k210054-cios-spin-fda-510k.jpg K210054 - Cios Spin K210054 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Systems USA, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k210055/ 2021-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k210055-cios-alpha-fda-510k.jpg K210055 - Cios Alpha K210055 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k210063/ 2021-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k210063-freudenberg-surgical-mask-fda-510k.jpg K210063 - Freudenberg Surgical Mask K210063 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Freudenberg Performance Materials LP. Cleared Feb 2021. https://www.510kdatabase.net/den200018/ 2021-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/den200018-exciteosa-with-remote-and-exciteosa-fda-510k.jpg DEN200018 - eXciteOSA with remote and eXciteOSA without remote DEN200018 is a FDA 510(k) cleared dental medical device. Manufacturer: Signifier Medical Technologies. Cleared Feb 2021. https://www.510kdatabase.net/k202493/ 2021-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k202493-medical-face-mask-fda-510k.jpg K202493 - Medical Face Mask K202493 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Gemtier Medical (Shanghai), Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k202872/ 2021-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k202872-prase-peek-anterior-cervical-interbody-fda-510k.jpg K202872 - Prase PEEK Anterior Cervical Interbody Spacer K202872 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Gbs Commonwealth Co., Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/k203573/ 2021-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k203573-response-navigation-instruments-fda-510k.jpg K203573 - RESPONSE Navigation Instruments K203573 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OrthoPediatrics Corp.. Cleared Feb 2021. https://www.510kdatabase.net/k203582/ 2021-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k203582-quibim-precision-prostate-qp-prostate-fda-510k.jpg K203582 - QUIBIM Precision Prostate (qp-Prostate) K203582 is a FDA 510(k) cleared radiology medical device. Manufacturer: Quibim S.L.. Cleared Feb 2021. https://www.510kdatabase.net/k210174/ 2021-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k210174-bemer-therapy-systems-bemer-classic-fda-510k.jpg K210174 - BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set K210174 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Bemer Int AG. Cleared Feb 2021. https://www.510kdatabase.net/k192568/ 2021-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k192568-jiajian-self-adhesive-electrode-fda-510k.jpg K192568 - Jiajian Self-Adhesive Electrode K192568 is a FDA 510(k) cleared neurology medical device. Manufacturer: Wuxi Jiajian Medical Instrument Co., Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/k200301/ 2021-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k200301-uniti-acdf-implant-system-fda-510k.jpg K200301 - UNiTi ACDF Implant System K200301 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Pressio, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k200636/ 2021-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k200636-axus-es-5-electro-acupuncture-device-fda-510k.jpg K200636 - AXUS ES-5 Electro-Acupuncture Device K200636 is a FDA 510(k) cleared neurology medical device. Manufacturer: Lhasa Oms, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k202027/ 2021-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k202027-balex-bone-expander-system-fda-510k.jpg K202027 - Balex bone Expander System K202027 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Taeyeon Medical Co., Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/k202151/ 2021-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k202151-smart-space-shoulder-system-fda-510k.jpg K202151 - Smart SPACE Shoulder System K202151 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Techmah Medical, LLC. Cleared Feb 2021. https://www.510kdatabase.net/k202627/ 2021-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k202627-medical-face-masks-fda-510k.jpg K202627 - Medical Face Masks K202627 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guilin Hbm Sanitary Protections, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k203294/ 2021-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k203294-arthrex-pilon-fusion-system-fda-510k.jpg K203294 - Arthrex Pilon Fusion System K203294 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k203420/ 2021-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k203420-ecofit-hip-system-fda-510k.jpg K203420 - EcoFit® Hip System K203420 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Implantcast GmbH. Cleared Feb 2021. https://www.510kdatabase.net/k203598/ 2021-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k203598-omnichroma-flow-bulk-fda-510k.jpg K203598 - Omnichroma Flow Bulk K203598 is a FDA 510(k) cleared dental medical device. Manufacturer: Tokuyama Dental Corporation. Cleared Feb 2021. https://www.510kdatabase.net/k193422/ 2021-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k193422-easydrip-pen-needle-easydrip-plus-pen-fda-510k.jpg K193422 - Easydrip Pen Needle, Easydrip Plus Pen Needle K193422 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sandstone Medical (Suzhou), Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k201231/ 2021-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k201231-ctxx85-ct-scanner-fda-510k.jpg K201231 - CTxx85 CT Scanner K201231 is a FDA 510(k) cleared radiology medical device. Manufacturer: Analogic Corporation. Cleared Feb 2021. https://www.510kdatabase.net/k202096/ 2021-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k202096-3-ply-ecoguard-b-with-earloop-3-ply-fda-510k.jpg K202096 - 3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On K202096 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ecoguard, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k202097/ 2021-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k202097-fundus-camera-fda-510k.jpg K202097 - Fundus Camera K202097 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Huvitz Co., Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/k202323/ 2021-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k202323-disposable-medical-surgical-masks-fda-510k.jpg K202323 - Disposable Medical Surgical Masks K202323 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Tianjin Teda Jinshan Easy Packing Manufacture Co., Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/k202331/ 2021-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k202331-medical-face-mask-fda-510k.jpg K202331 - Medical Face Mask K202331 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Gemtier Medical (Shanghai), Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k202511/ 2021-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k202511-disposable-medical-surgical-mask-fda-510k.jpg K202511 - Disposable Medical Surgical Mask K202511 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Improve Medical (Hunan) Co., Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/k203278/ 2021-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k203278-independence-spacers-hedron-ia-magnify-fda-510k.jpg K203278 - INDEPENDENCE Spacers, HEDRON IA, MAGNIFY-S Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, ELSA Spacers K203278 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k203299/ 2021-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k203299-cellfx-system-fda-510k.jpg K203299 - CellFX System K203299 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Pulse Biosciences, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k203553/ 2021-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k203553-vantage-galan-3t-mrt-3020-v70-with-fda-510k.jpg K203553 - Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR K203553 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Feb 2021. https://www.510kdatabase.net/k203634/ 2021-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k203634-biopoly-great-toe-hemiarthroplasty-fda-510k.jpg K203634 - BioPoly Great Toe Hemiarthroplasty Implant K203634 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: BioPoly, LLC. Cleared Feb 2021. https://www.510kdatabase.net/k203667/ 2021-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k203667-ezray-m-model-vmx-p300-fda-510k.jpg K203667 - EzRay M (Model: VMX-P300) K203667 is a FDA 510(k) cleared radiology medical device. Manufacturer: VATECH Co., Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/k203393/ 2021-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k203393-fast-fix-flex-fda-510k.jpg K203393 - FAST-FIX FLEX K203393 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k203483/ 2021-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k203483-medispo-rubber-surgical-gloves-medispo-fda-510k.jpg K203483 - Medispo Rubber Surgical Gloves, Medispo Polyisoprene Surgical Gloves K203483 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guilin Hbm Health Protections, Inc.. Cleared Feb 2021. https://www.510kdatabase.net/k203537/ 2021-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k203537-proteus-xrf-models-st-and-et-multirad-fda-510k.jpg K203537 - Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems K203537 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sedecal., Sa.. Cleared Feb 2021. https://www.510kdatabase.net/k203568/ 2021-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k203568-hoffmann-lrf-system-fda-510k.jpg K203568 - Hoffmann LRF System K203568 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker GmbH. Cleared Feb 2021. https://www.510kdatabase.net/k203603/ 2021-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k203603-monopolar-hook-fda-510k.jpg K203603 - Monopolar Hook K203603 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Human Xtensions , Ltd.. Cleared Feb 2021. https://www.510kdatabase.net/k203794/ 2021-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k203794-healix-ti-dual-threaded-suture-anchor-fda-510k.jpg K203794 - HEALIX Ti Dual Threaded Suture Anchor with DYNATAPE Suture K203794 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International SARL. Cleared Feb 2021. https://www.510kdatabase.net/k190677/ 2021-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k190677-endoclot-fda-510k.jpg K190677 - EndoClot K190677 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Endoclot Plus Co., Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k191878/ 2021-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k191878-dex-device-fda-510k.jpg K191878 - DEX Device K191878 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Dex Surgical. Cleared Jan 2021. https://www.510kdatabase.net/k192650/ 2021-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k192650-ispace-15t-superconducting-magnetic-fda-510k.jpg K192650 - i_Space 1.5T Superconducting Magnetic Resonance Imaging System K192650 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mri Division,Beijing Wandong Medical Technology Co., Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k200429/ 2021-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k200429-bee-cages-fda-510k.jpg K200429 - BEE Cages K200429 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: NGMedical GmbH. Cleared Jan 2021. https://www.510kdatabase.net/k201411/ 2021-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k201411-visage-breast-density-fda-510k.jpg K201411 - Visage Breast Density K201411 is a FDA 510(k) cleared radiology medical device. Manufacturer: Visage Imaging GmbH. Cleared Jan 2021. https://www.510kdatabase.net/k201418/ 2021-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k201418-sunset-heated-cpap-tube-fda-510k.jpg K201418 - Sunset Heated CPAP Tube K201418 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sunset Healthcare Solutions, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k201620/ 2021-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k201620-luna-g3-bpap-25a-fda-510k.jpg K201620 - Luna® G3 BPAP 25A K201620 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: 3B Medical, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k201752/ 2021-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k201752-disposable-pre-calibrated-suction-fda-510k.jpg K201752 - Disposable Pre-calibrated Suction K201752 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Jan 2021. https://www.510kdatabase.net/k201801/ 2021-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k201801-rapid-acoustic-pulse-device-fda-510k.jpg K201801 - Rapid Acoustic Pulse Device K201801 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Soliton, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k201838/ 2021-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k201838-pediflex-flexible-nail-system-fda-510k.jpg K201838 - PediFlex Flexible Nail System K201838 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OrthoPediatrics Corp.. Cleared Jan 2021. https://www.510kdatabase.net/k201993/ 2021-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k201993-e-connect-s-endo-motor-with-built-in-fda-510k.jpg K201993 - E-connect S Endo Motor with built-in Apex Locator K201993 is a FDA 510(k) cleared dental medical device. Manufacturer: Changzhou Sifary Medical Technology Co., Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k202221/ 2021-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k202221-vx650-fda-510k.jpg K202221 - VX650 K202221 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Luneau Technology Operations. Cleared Jan 2021. https://www.510kdatabase.net/k202282/ 2021-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k202282-neodent-implant-system-zirconia-fda-510k.jpg K202282 - Neodent Implant System - Zirconia Implant System K202282 is a FDA 510(k) cleared dental medical device. Manufacturer: Jjgc Industria E Comercio DE Materiais Dentarios S.A.. Cleared Jan 2021. https://www.510kdatabase.net/k202310/ 2021-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k202310-wildcat-pe-surgical-isolation-gown-fda-510k.jpg K202310 - Wildcat PE Surgical Isolation Gown Open Back, Wildcat PE Surgical Isolation Gown Full Back K202310 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wildcat Ppe, LLC. Cleared Jan 2021. https://www.510kdatabase.net/k202358/ 2021-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k202358-protective-face-mask-for-medical-use-fda-510k.jpg K202358 - Protective Face Mask for Medical Use K202358 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hunan Heng Chang Pharmaceutical Co., Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k202366/ 2021-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k202366-magic-infusion-catheter-fda-510k.jpg K202366 - MAGIC Infusion Catheter K202366 is a FDA 510(k) cleared neurology medical device. Manufacturer: Balt USA, LLC. Cleared Jan 2021. https://www.510kdatabase.net/k202398/ 2021-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k202398-ti3z-cervical-interbody-system-fda-510k.jpg K202398 - Ti3Z Cervical Interbody System K202398 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zavation Medical Products, LLC. Cleared Jan 2021. https://www.510kdatabase.net/k202878/ 2021-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k202878-prase-ap-anterior-cervical-plate-system-fda-510k.jpg K202878 - Prase-AP Anterior Cervical Plate System K202878 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Gbs Commonwealth Co., Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k202970/ 2021-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k202970-ventway-sparrow-fda-510k.jpg K202970 - Ventway Sparrow K202970 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Inovytech Medical Solutions , Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k203220/ 2021-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k203220-cobas-bkv-fda-510k.jpg K203220 - cobas BKV K203220 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Molecular Systems, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k203531/ 2021-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k203531-xypan-expandable-lumbar-cage-system-fda-510k.jpg K203531 - XYPAN Expandable Lumbar Cage System K203531 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aegis Spine, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k200289/ 2021-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k200289-michler-kapp-cardiovascular-vent-fda-510k.jpg K200289 - Michler-Kapp Cardiovascular Vent Catheter K200289 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Kapp Surgical Instrument, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k200384/ 2021-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k200384-hipxpert-3d-display-and-anchoring-fda-510k.jpg K200384 - HipXpert 3D Display and Anchoring Application K200384 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Surgical Planning Associates, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k201016/ 2021-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k201016-luofucon-phmb-alginate-dressing-rx-use-fda-510k.jpg K201016 - LUOFUCON PHMB Alginate Dressing (Rx use), LUOFUCON PHMB Antibacterial Alginate Wound Dressing (OTC use) K201016 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Huizhou Foryou Medical Devices Co., Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k201608/ 2021-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k201608-genesiszr-uht700-zirconia-fda-510k.jpg K201608 - GenesisZr UHT700 Zirconia K201608 is a FDA 510(k) cleared dental medical device. Manufacturer: United Dental Resources Corporation. Cleared Jan 2021. https://www.510kdatabase.net/k202524/ 2021-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k202524-standard-sterilizable-tray-fda-510k.jpg K202524 - Standard Sterilizable Tray K202524 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Implant Direct Sybron Manufacturing, LLC. Cleared Jan 2021. https://www.510kdatabase.net/k202754/ 2021-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k202754-masterscope-masterscope-ct-masterscope-fda-510k.jpg K202754 - MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU K202754 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Eresearchtechnology GmbH. Cleared Jan 2021. https://www.510kdatabase.net/k202892/ 2021-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k202892-vital-signs-monitorim3s-im3as-im3bs-fda-510k.jpg K202892 - Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s K202892 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edan Instruments, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k203223/ 2021-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k203223-reliance-eps-endoscope-processing-fda-510k.jpg K203223 - Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide K203223 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Steris. Cleared Jan 2021. https://www.510kdatabase.net/k203474/ 2021-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k203474-biomet-microfixation-ribfix-advantage-fda-510k.jpg K203474 - Biomet Microfixation RibFix Advantage System K203474 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet Micofixation. Cleared Jan 2021. https://www.510kdatabase.net/k203507/ 2021-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k203507-vitality-spinal-fixation-system-fda-510k.jpg K203507 - Vitality® Spinal Fixation System K203507 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer Biomet Spine, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k203840/ 2021-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k203840-boss-8f-balloon-guide-catheter-fda-510k.jpg K203840 - BOSS 8F Balloon Guide Catheter K203840 is a FDA 510(k) cleared neurology medical device. Manufacturer: Marblehead Medical, LLC. Cleared Jan 2021. https://www.510kdatabase.net/k193386/ 2021-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k193386-wrist-electronic-sphygmomanometer-fda-510k.jpg K193386 - Wrist Electronic Sphygmomanometer K193386 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Changkun Technology Co., Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k193387/ 2021-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k193387-arm-electronic-sphygmomanometer-fda-510k.jpg K193387 - Arm Electronic Sphygmomanometer K193387 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Changkun Technology Co., Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k193586/ 2021-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k193586-vivo-45-ls-fda-510k.jpg K193586 - Vivo 45 LS K193586 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Breas Medical AB. Cleared Jan 2021. https://www.510kdatabase.net/k203405/ 2021-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k203405-evos-large-fragment-plating-system-fda-510k.jpg K203405 - EVOS Large Fragment Plating System K203405 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k200922/ 2021-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k200922-altus-spine-ha-pedicle-screw-system-fda-510k.jpg K200922 - Altus Spine HA Pedicle Screw System K200922 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Altus Partners, LLC. Cleared Jan 2021. https://www.510kdatabase.net/k201300/ 2021-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k201300-airway-mobilescope-fda-510k.jpg K201300 - Airway Mobilescope K201300 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Jan 2021. https://www.510kdatabase.net/k202199/ 2021-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k202199-btl-899st-fda-510k.jpg K202199 - BTL-899ST K202199 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Btl. Cleared Jan 2021. https://www.510kdatabase.net/k202934/ 2021-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k202934-blood-pressure-monitor-fda-510k.jpg K202934 - Blood Pressure Monitor K202934 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bioland Technology, Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k203104/ 2021-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k203104-ibm-iconnect-access-fda-510k.jpg K203104 - IBM iConnect Access K203104 is a FDA 510(k) cleared radiology medical device. Manufacturer: Merge Healthcare Incorporated. Cleared Jan 2021. https://www.510kdatabase.net/k203482/ 2021-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k203482-must-pedicle-screw-extension-and-long-fda-510k.jpg K203482 - M.U.S.T. Pedicle Screw Extension and Long Tab Implants K203482 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Jan 2021. https://www.510kdatabase.net/k203803/ 2021-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k203803-vasoband-vascular-compression-device-fda-510k.jpg K203803 - VASOBand Vascular Compression Device K203803 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vasoinnovations, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k203849/ 2021-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k203849-general-radiography-cxdi-cs01-fda-510k.jpg K203849 - General Radiography CXDI-CS01 K203849 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k201468/ 2021-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k201468-pulse-oximeter-fda-510k.jpg K201468 - Pulse Oximeter K201468 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Creative Industry Co., Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k202742/ 2021-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k202742-dolphiniq-dolphin4d-and-dolphinmax-fda-510k.jpg K202742 - Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory K202742 is a FDA 510(k) cleared radiology medical device. Manufacturer: Viasonix , Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k202856/ 2021-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k202856-diagnostic-ultrasound-system-models-fda-510k.jpg K202856 - Diagnostic Ultrasound System, Models: Acclarix AX3, Acclarix AX3 Exp, Acclarix AX3 Super, Acclarix AX25, Acclarix AX28, Acclarix AX2, Acclarix AX2 Exp, Acclarix AX2 Super, Acclarix AX15, Acclarix AX18, Acclarix LX3, Acclarix LX3 Exp, Acclarix LX3 Super, Acclarix LX25 and Acclarix LX28 K202856 is a FDA 510(k) cleared radiology medical device. Manufacturer: Edan Instruments, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k203327/ 2021-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k203327-vertaconnect-tlif-cage-fda-510k.jpg K203327 - VERTACONNECT TLIF Cage K203327 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Signus Medizintechnik. Cleared Jan 2021. https://www.510kdatabase.net/k203453/ 2021-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k203453-bd-hypodermic-syringe-fda-510k.jpg K203453 - BD Hypodermic Syringe K203453 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson and Company. Cleared Jan 2021. https://www.510kdatabase.net/k203747/ 2021-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k203747-non-contact-forehead-thermometer-fda-510k.jpg K203747 - Non-Contact Forehead Thermometer (Models UT306H & UT308H) K203747 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Uni-Trend Technology (China) Co., Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k203797/ 2021-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k203797-vatech-a9-model-pht-30css-fda-510k.jpg K203797 - vatech A9 (Model : PHT-30CSS) K203797 is a FDA 510(k) cleared radiology medical device. Manufacturer: VATECH Co., Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k201187/ 2021-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k201187-cytoplast-titanium-reinforced-ptfe-fda-510k.jpg K201187 - Cytoplast Titanium-Reinforced PTFE Membranes K201187 is a FDA 510(k) cleared dental medical device. Manufacturer: Osteogenics Biomedical, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k202336/ 2021-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k202336-patient-monitor-fda-510k.jpg K202336 - Patient Monitor K202336 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edan Instruments, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k193266/ 2021-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k193266-miin-fda-510k.jpg K193266 - MIIN K193266 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medico USA, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k200037/ 2021-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k200037-piccolo-medical-smartpicc-system-fda-510k.jpg K200037 - Piccolo Medical SmartPICC System K200037 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Piccolo Medical, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k201066/ 2021-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k201066-enseal-x1-tissue-sealer-curved-jaw-25-fda-510k.jpg K201066 - ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length K201066 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon Endo-Surgery, LLC. Cleared Jan 2021. https://www.510kdatabase.net/k201553/ 2021-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k201553-simply-iconic-implants-fda-510k.jpg K201553 - Simply Iconic Implants K201553 is a FDA 510(k) cleared dental medical device. Manufacturer: Implant Direct Sybron Manufacturing, LLC. Cleared Jan 2021. https://www.510kdatabase.net/k201696/ 2021-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k201696-enseal-x1-tissue-sealer-straight-jaw-fda-510k.jpg K201696 - ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length K201696 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon Endo-Surgery, LLC. Cleared Jan 2021. https://www.510kdatabase.net/k201782/ 2021-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k201782-nuface-trinity-plus-device-fda-510k.jpg K201782 - NuFace Trinity Plus Device K201782 is a FDA 510(k) cleared neurology medical device. Manufacturer: Carol Cole Company Dba Nuface. Cleared Jan 2021. https://www.510kdatabase.net/k202415/ 2021-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k202415-virtuerf-fda-510k.jpg K202415 - VirtueRF K202415 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: ShenB Co., Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k202575/ 2021-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k202575-clearpoint-array-system-fda-510k.jpg K202575 - ClearPoint Array System K202575 is a FDA 510(k) cleared neurology medical device. Manufacturer: ClearPoint Neuro, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k202640/ 2021-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k202640-surgical-mask-fda-510k.jpg K202640 - Surgical Mask K202640 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Medpure Biological Technology Co., Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k202660/ 2021-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k202660-sprint-pns-system-fda-510k.jpg K202660 - SPRINT PNS System K202660 is a FDA 510(k) cleared neurology medical device. Manufacturer: Spr Therapeutics, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k202792/ 2021-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k202792-brius-clear-aligners-fda-510k.jpg K202792 - BRIUS Clear Aligners K202792 is a FDA 510(k) cleared dental medical device. Manufacturer: Brius Technologies, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k202858/ 2021-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k202858-flex-threadtm-distal-fibula-fda-510k.jpg K202858 - Flex-ThreadTM Distal Fibula Intramedullary Nail System K202858 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Conventus Orthopaedics, LLC. Cleared Jan 2021. https://www.510kdatabase.net/k203010/ 2021-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k203010-platinum-drf-imaging-system-fda-510k.jpg K203010 - Platinum dRF Imaging System K203010 is a FDA 510(k) cleared radiology medical device. Manufacturer: Apelem-Dms Group. Cleared Jan 2021. https://www.510kdatabase.net/k203131/ 2021-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k203131-ev1000-clinical-platform-non-invasive-fda-510k.jpg K203131 - EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform K203131 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Jan 2021. https://www.510kdatabase.net/k203181/ 2021-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k203181-nerivio-fgd000075-47-fda-510k.jpg K203181 - Nerivio, FGD000075-4.7 K203181 is a FDA 510(k) cleared neurology medical device. Manufacturer: Theranica Bioelectronics , Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k203373/ 2021-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k203373-advanced-research-medical-trident-si-fda-510k.jpg K203373 - Advanced Research Medical Trident SI Screw System K203373 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Advanced Research Medical, LLC. Cleared Jan 2021. https://www.510kdatabase.net/k203656/ 2021-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k203656-non-contact-forehead-thermometer-ut30h-fda-510k.jpg K203656 - Non-Contact Forehead Thermometer (UT30H) K203656 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Uni-Trend Technology (China) Co., Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k200731/ 2021-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k200731-pjur-aqua-baseline-pjur-aqua-guarana-fda-510k.jpg K200731 - pjur AQUA Baseline, pjur AQUA Guarana, pjur AQUA ProVitamin B5, pjur BACK DOOR anal Provitamin B5 K200731 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Pjur Group Luxembourg S.A.. Cleared Jan 2021. https://www.510kdatabase.net/k201366/ 2021-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k201366-forwarts-fda-510k.jpg K201366 - Forwarts K201366 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Pronova Laboratories BV. Cleared Jan 2021. https://www.510kdatabase.net/k201758/ 2021-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k201758-evis-exera-iii-bronchovideoscope-fda-510k.jpg K201758 - EVIS EXERA III Bronchovideoscope Olympus BF-XP190, EVIS EXERA III Bronchovideoscope Olympus BF-P190 K201758 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Jan 2021. https://www.510kdatabase.net/k202391/ 2021-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k202391-dir-800-fda-510k.jpg K202391 - DIR 800 K202391 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k202408/ 2021-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k202408-cobas-ctng-for-use-on-cobas-68008800-fda-510k.jpg K202408 - cobas CTNG for use on cobas 6800/8800 systems K202408 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Molecular Systems, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k202507/ 2021-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k202507-eea-circular-stapler-with-tri-staple-fda-510k.jpg K202507 - EEA Circular Stapler with Tri-Staple Technology K202507 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien. Cleared Jan 2021. https://www.510kdatabase.net/k202595/ 2021-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k202595-premier-guard-usa-3-layer-ear-loop-fda-510k.jpg K202595 - Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face Mask K202595 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Premier Guard USA, LLC. Cleared Jan 2021. https://www.510kdatabase.net/k202672/ 2021-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k202672-precision-delivery-infusion-set-fda-510k.jpg K202672 - Precision Delivery Infusion Set K202672 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Quest Medical, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k202839/ 2021-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k202839-overlapped-compression-therapy-fda-510k.jpg K202839 - Overlapped Compression Therapy K202839 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Jkh Health Co., Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k202904/ 2021-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k202904-surgical-face-mask-fda-510k.jpg K202904 - Surgical Face Mask K202904 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangxi Feilikang Medical Technology Co., Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k203189/ 2021-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k203189-aerocure-md-fda-510k.jpg K203189 - AEROCURE-MD K203189 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Aerobiotix, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k202629/ 2021-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k202629-dentsply-sirona-universal-spray-glazes-fda-510k.jpg K202629 - Dentsply Sirona Universal Spray Glazes K202629 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona. Cleared Jan 2021. https://www.510kdatabase.net/k192913/ 2021-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k192913-rd-series-nova-compo-b-plus-bottle-rd-fda-510k.jpg K192913 - R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose K192913 is a FDA 510(k) cleared dental medical device. Manufacturer: Imicryl Dis Malzemeleri Sanayi VE Ticaret AS. Cleared Jan 2021. https://www.510kdatabase.net/k200163/ 2021-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k200163-ava-fertility-tracker-fda-510k.jpg K200163 - Ava Fertility Tracker K200163 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ava AG. Cleared Jan 2021. https://www.510kdatabase.net/k201219/ 2021-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k201219-biocore9-femoral-head-resurfacing-fda-510k.jpg K201219 - Biocore9 Femoral Head Resurfacing Component K201219 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biocore9, LLC. Cleared Jan 2021. https://www.510kdatabase.net/k201685/ 2021-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k201685-potenza-fda-510k.jpg K201685 - Potenza K201685 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Jeisys Medical, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k202363/ 2021-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k202363-hbp7-settable-hemostatic-bone-putty-fda-510k.jpg K202363 - HBP7 Settable Hemostatic Bone Putty K202363 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Orthocon, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k202833/ 2021-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k202833-sequel-external-fixation-device-fda-510k.jpg K202833 - Sequel External Fixation Device K202833 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Sequel Medical, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k203153/ 2021-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k203153-creo-stabilization-system-navigation-fda-510k.jpg K203153 - CREO Stabilization System, Navigation Instruments, ExcelsiusGPS K203153 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k203485/ 2021-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k203485-snugfit-all-suture-anchor-fda-510k.jpg K203485 - SnugFit All-Suture Anchor K203485 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Jan 2021. https://www.510kdatabase.net/k203719/ 2021-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k203719-intrasight-mobile-fda-510k.jpg K203719 - IntraSight Mobile K203719 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Volcano Corporation. Cleared Jan 2021. https://www.510kdatabase.net/k203726/ 2021-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k203726-acuson-acunav-volume-intracardiac-fda-510k.jpg K203726 - ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter K203726 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k200565/ 2021-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k200565-galapogos-fda-510k.jpg K200565 - Galapogos K200565 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: ResMed Corp. Cleared Jan 2021. https://www.510kdatabase.net/k201930/ 2021-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k201930-nanum-syringe-fda-510k.jpg K201930 - Nanum Syringe K201930 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Nanum Company Co., Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k193271/ 2021-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k193271-uai-easytriage-rib-fda-510k.jpg K193271 - uAI EasyTriage-Rib K193271 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Intelligence Co., Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k193608/ 2021-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k193608-eberle-shaver-system-c3-and-accessories-fda-510k.jpg K193608 - EBERLE Shaver System C3 and Accessories K193608 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Eberle GmbH & Co. KG. Cleared Jan 2021. https://www.510kdatabase.net/k201085/ 2021-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k201085-neva-pv-thrombectomy-device-fda-510k.jpg K201085 - NeVa PV Thrombectomy Device K201085 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vesalio. Cleared Jan 2021. https://www.510kdatabase.net/k201579/ 2021-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k201579-infrared-thermometer-fda-510k.jpg K201579 - Infrared Thermometer K201579 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen Xunwei Industrial Co., Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k201582/ 2021-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k201582-non-contact-electronic-forehead-fda-510k.jpg K201582 - Non-contact Electronic Forehead Infrared Thermometer K201582 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zhongshan Jinli Electronic Weighing? Equipment Co., Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k201650/ 2021-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k201650-vmcore-biopsy-needle-fda-510k.jpg K201650 - VMCore Biopsy Needle K201650 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Uro-1, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k201897/ 2021-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k201897-sensor-ureterorenoscope-9-fr-wl-600-mm-fda-510k.jpg K201897 - Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525 K201897 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Richard Wolf Medical Instruments Corporation. Cleared Jan 2021. https://www.510kdatabase.net/k202107/ 2021-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k202107-medical-protective-mask-fda-510k.jpg K202107 - Medical Protective Mask K202107 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guangdong Kingfa Sci. & Tech.Co., Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k202141/ 2021-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k202141-scorpion-stylet-portal-vein-access-set-fda-510k.jpg K202141 - Scorpion Stylet Portal Vein Access Set, Scorpion Needle Portal Vein Access Set K202141 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Argon Medical Devices, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k202653/ 2021-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k202653-gymform-total-abs-fda-510k.jpg K202653 - Gymform Total ABS K202653 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Well Brain International , Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k202767/ 2021-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k202767-vantage-orian-15t-mrt-1550-v60-fda-510k.jpg K202767 - Vantage Orian 1.5T, MRT-1550, V6.0 K202767 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Jan 2021. https://www.510kdatabase.net/k202826/ 2021-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k202826-immulite-2000-cortisol-fda-510k.jpg K202826 - IMMULITE® 2000 Cortisol K202826 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Siemens Healthcare Diagnostics Products, Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k202847/ 2021-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k202847-accubrain-fda-510k.jpg K202847 - AccuBrain K202847 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainnow Medical Technology Limited. Cleared Jan 2021. https://www.510kdatabase.net/k203142/ 2021-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k203142-veuron-brain-pab-fda-510k.jpg K203142 - Veuron-Brain-pAb K203142 is a FDA 510(k) cleared radiology medical device. Manufacturer: Heuron Co., Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k203209/ 2021-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k203209-airphysio-positive-expiratory-pressure-fda-510k.jpg K203209 - AirPhysio Positive Expiratory Pressure (PEP) Device K203209 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Airphysio Pty, Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k203270/ 2021-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k203270-immuliteimmulite-1000-cortisol-fda-510k.jpg K203270 - IMMULITE/IMMULITE® 1000 Cortisol K203270 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics Products, Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k203308/ 2021-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k203308-ali-interbody-fusion-system-fda-510k.jpg K203308 - Ali Interbody Fusion System K203308 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Raed M. Ali, M.D., Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k203381/ 2021-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k203381-dynanail-mini-hybrid-fda-510k.jpg K203381 - Dynanail Mini Hybrid K203381 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: MedShape, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k203506/ 2021-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k203506-perla-tl-posterior-osteosynthesis-system-fda-510k.jpg K203506 - PERLA® TL posterior osteosynthesis system K203506 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spineart. Cleared Jan 2021. https://www.510kdatabase.net/k203677/ 2021-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k203677-viewpoint-6-fda-510k.jpg K203677 - ViewPoint 6 K203677 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. Cleared Jan 2021. https://www.510kdatabase.net/k203678/ 2021-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k203678-cd-horizon-spinal-system-fda-510k.jpg K203678 - CD HORIZON™ Spinal System K203678 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k203683/ 2021-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k203683-carboclear-lumbar-cage-system-fda-510k.jpg K203683 - CarboClear Lumbar Cage System K203683 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Carbofix Orthpedics , Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k200702/ 2021-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k200702-easypath-rf-introducer-sheath-fda-510k.jpg K200702 - EasyPath RF Introducer Sheath K200702 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Broncus Medical, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k201719/ 2021-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k201719-vital-sleep-fda-510k.jpg K201719 - Vital Sleep K201719 is a FDA 510(k) cleared dental medical device. Manufacturer: The Snore Reliever Company, LLC. Cleared Jan 2021. https://www.510kdatabase.net/k201922/ 2021-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k201922-trophikos-vaginal-moisturizer-fda-510k.jpg K201922 - Trophikos Vaginal Moisturizer K201922 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Trophikos, LLC. Cleared Jan 2021. https://www.510kdatabase.net/k202019/ 2021-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k202019-maven-patient-specific-instrumentation-fda-510k.jpg K202019 - Maven Patient-Specific Instrumentation K202019 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paragon 28, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k202104/ 2021-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k202104-bioguard-eus-airwater-and-suction-valves-fda-510k.jpg K202104 - BioGuard EUS Air/Water and Suction Valves K202104 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: STERIS Corporation. Cleared Jan 2021. https://www.510kdatabase.net/k202333/ 2021-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k202333-lockado-repositionable-hemostasis-clip-fda-510k.jpg K202333 - Lockado Repositionable Hemostasis Clip K202333 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Micro-Tech (Nanjing) Co., Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k202694/ 2021-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k202694-vycor-medical-viewsite-brain-access-fda-510k.jpg K202694 - Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”) K202694 is a FDA 510(k) cleared neurology medical device. Manufacturer: Vycor Medical, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k202700/ 2021-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k202700-art-plan-fda-510k.jpg K202700 - ART-Plan K202700 is a FDA 510(k) cleared radiology medical device. Manufacturer: Therapanacea. Cleared Jan 2021. https://www.510kdatabase.net/k202769/ 2021-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k202769-velys-robotic-assisted-solution-fda-510k.jpg K202769 - VELYS™ Robotic-Assisted Solution K202769 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Ireland UC. Cleared Jan 2021. https://www.510kdatabase.net/k203241/ 2021-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k203241-omniguide-beampath-oto-u-fiber-fda-510k.jpg K203241 - OmniGuide BeamPath OTO-U Fiber K203241 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Omniguide, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k203669/ 2021-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k203669-mobius3d-fda-510k.jpg K203669 - Mobius3D K203669 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k192933/ 2021-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k192933-polyisoprene-powder-free-black-colour-fda-510k.jpg K192933 - Polyisoprene Powder Free, Black Colour Surgical Gloves K192933 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Emerson & Co. Srl. Cleared Jan 2021. https://www.510kdatabase.net/k200609/ 2021-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k200609-entity-wifi-video-nasopharyngoscope-fda-510k.jpg K200609 - ENTity WiFi Video Nasopharyngoscope System K200609 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Optim, LLC. Cleared Jan 2021. https://www.510kdatabase.net/k201014/ 2021-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k201014-myonyx-system-fda-510k.jpg K201014 - MyOnyx System K201014 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Thought Technology , Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k201700/ 2021-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k201700-bego-semados-rsrsx-implant-system-fda-510k.jpg K201700 - BEGO Semados® RS/RSX Implant System K201700 is a FDA 510(k) cleared dental medical device. Manufacturer: Bego Implant Systems GmbH & Co. KG. Cleared Jan 2021. https://www.510kdatabase.net/k202314/ 2021-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k202314-procedure-face-mask-model-kkf-2a-fda-510k.jpg K202314 - Procedure face mask (Model: KKF-2A) K202314 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Han Zhaoqing Sporting Goods Company Limited. Cleared Jan 2021. https://www.510kdatabase.net/k203105/ 2021-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k203105-inion-compresson-screw-fda-510k.jpg K203105 - Inion CompressOn Screw K203105 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Inion OY. Cleared Jan 2021. https://www.510kdatabase.net/k203639/ 2021-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k203639-stealthstation-cranial-software-v132-fda-510k.jpg K203639 - StealthStation Cranial Software v1.3.2 K203639 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Navigation, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k203671/ 2021-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k203671-must-sacral-iliac-screw-and-pelvic-fda-510k.jpg K203671 - M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System K203671 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Jan 2021. https://www.510kdatabase.net/k201625/ 2021-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k201625-disposable-medical-surgical-mask-fda-510k.jpg K201625 - Disposable Medical Surgical Mask K201625 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Tianjin Saiyuan Technology Co., Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k201836/ 2021-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k201836-aquilion-lightning-tsx-036a7-v102-with-fda-510k.jpg K201836 - Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i K201836 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Jan 2021. https://www.510kdatabase.net/k202843/ 2021-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k202843-surgical-face-masks-sterile-surgical-fda-510k.jpg K202843 - Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile) K202843 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k203129/ 2021-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k203129-nexgen-standalone-anterior-cervical-fda-510k.jpg K203129 - NexGen Standalone Anterior Cervical Discectomy and Fusion (ACDF) System K203129 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Precision Spine, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k203201/ 2021-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k203201-nuvasive-thoracolumbar-interbody-fda-510k.jpg K203201 - NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Hyperlordotic System, Brigade Standalone System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, Modulus ALIF System K203201 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Jan 2021. https://www.510kdatabase.net/k203280/ 2021-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k203280-hepatica-v1-hepatica-v100-fda-510k.jpg K203280 - Hepatica v1 (Hepatica v1.0.0) K203280 is a FDA 510(k) cleared radiology medical device. Manufacturer: Perspectum, Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k203526/ 2021-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k203526-c-scope-visualization-system-fda-510k.jpg K203526 - C Scope Visualization System K203526 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Cit Ortho. Cleared Jan 2021. https://www.510kdatabase.net/k203658/ 2021-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k203658-micro-c-medical-imaging-system-m01-fda-510k.jpg K203658 - Micro C Medical Imaging System, M01 K203658 is a FDA 510(k) cleared radiology medical device. Manufacturer: Oxos Medical, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k193079/ 2021-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k193079-ice-compression-first-duo-moove-systems-fda-510k.jpg K193079 - ICE COMPRESSION FIRST, DUO, & MOOVE Systems K193079 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Mks Paris. Cleared Jan 2021. https://www.510kdatabase.net/k201241/ 2021-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k201241-striate-fda-510k.jpg K201241 - Striate+™ K201241 is a FDA 510(k) cleared dental medical device. Manufacturer: Orthocell, Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k201471/ 2021-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k201471-m-vizion-femoral-revision-system-fda-510k.jpg K201471 - M-Vizion Femoral Revision System Extension K201471 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Jan 2021. https://www.510kdatabase.net/k202505/ 2021-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k202505-getset-surgical-goplf-posterior-fda-510k.jpg K202505 - GetSet Surgical GoPLF! Posterior Lateral Fusion System K202505 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Getset Surgical, SA. Cleared Jan 2021. https://www.510kdatabase.net/k202577/ 2021-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k202577-medical-surgical-mask-model-mp002-5-fda-510k.jpg K202577 - Medical Surgical Mask-Model MP002-5, MP002-6 K202577 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangmen Sure&Me Medical Product Co., Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k203231/ 2021-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k203231-switched-internal-paddles-fda-510k.jpg K203231 - Switched Internal Paddles K203231 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Philips North America, LLC. Cleared Jan 2021. https://www.510kdatabase.net/k203397/ 2021-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k203397-marrow-pack-white-11gauge10cm-or-fda-510k.jpg K203397 - Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or 13gauge/10cm, Marrow-Set (violet)- 11gauge/10cm or 13gauge/10cm, Marrow-kit (grey)- 11gauge/10cm or 13gauge/10cm, Marrow-Stem (green)- 11gauge/10cm or 13gauge/10cm K203397 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Biopsybell S.R.L.. Cleared Jan 2021. https://www.510kdatabase.net/k200717/ 2021-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k200717-clewicu-system-clewicuserver-and-fda-510k.jpg K200717 - CLEWICU System (ClewICUServer and ClewICUnitor) K200717 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Clew Medical , Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k202874/ 2021-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k202874-puritan-bennett-cuff-pressure-manager-fda-510k.jpg K202874 - Puritan Bennett Cuff Pressure Manager K202874 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Covidien, LLC. Cleared Jan 2021. https://www.510kdatabase.net/k201259/ 2021-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k201259-ortholoc-2-with-3di-technology-pilon-fda-510k.jpg K201259 - ORTHOLOC 2 with 3Di Technology Pilon Fracture Plating System K201259 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jan 2021. https://www.510kdatabase.net/k201778/ 2021-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k201778-i-stat-tbi-plasma-cartridge-with-the-i-fda-510k.jpg K201778 - i-STAT TBI Plasma cartridge with the i-STAT Alinity System K201778 is a FDA 510(k) cleared immunology medical device. Manufacturer: Abbott Laboratories. Cleared Jan 2021. https://www.510kdatabase.net/k202017/ 2021-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k202017-passion-natural-water-based-lubricant-fda-510k.jpg K202017 - Passion Natural Water Based Lubricant K202017 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Xr, LLC. Cleared Jan 2021. https://www.510kdatabase.net/k202278/ 2021-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k202278-obs-anchorage-screw-biokey-anchorage-fda-510k.jpg K202278 - OBS Anchorage Screw, Biokey Anchorage Screw K202278 is a FDA 510(k) cleared dental medical device. Manufacturer: Bomei Co, Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k202291/ 2021-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k202291-button-loop-fda-510k.jpg K202291 - Button Loop K202291 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Yunyi (Beijing) Medical Device Co., Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k202721/ 2021-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k202721-celerity-20-steam-biological-indicator-fda-510k.jpg K202721 - Celerity 20 Steam Biological Indicator for IUSS K202721 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Jan 2021. https://www.510kdatabase.net/k203114/ 2021-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k203114-logiq-p10-logiq-p9-logiq-p8-fda-510k.jpg K203114 - LOGIQ P10, LOGIQ P9, LOGIQ P8 K203114 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared Jan 2021. https://www.510kdatabase.net/k203329/ 2021-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k203329-heartflow-analysis-fda-510k.jpg K203329 - HeartFlow Analysis K203329 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: HeartFlow, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k203341/ 2021-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k203341-acs-ld-uni-fb-knee-system-fda-510k.jpg K203341 - ACS LD Uni FB Knee System K203341 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Implantcast GmbH. Cleared Jan 2021. https://www.510kdatabase.net/k203630/ 2021-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k203630-bioguard-airwater-and-suction-valves-fda-510k.jpg K203630 - BioGuard Air/Water and Suction Valves K203630 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Steris Corporations. Cleared Jan 2021. https://www.510kdatabase.net/k200918/ 2021-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k200918-surgiwrap-frost-fda-510k.jpg K200918 - SurgiWrap FROST K200918 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Mast Biosurgery. Cleared Jan 2021. https://www.510kdatabase.net/k201577/ 2021-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k201577-matriderm-fda-510k.jpg K201577 - MatriDerm K201577 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medskin Solutions Dr. Suwelack AG. Cleared Jan 2021. https://www.510kdatabase.net/k202405/ 2021-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k202405-benevision-n12-benevision-n15-fda-510k.jpg K202405 - BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19, BeneVision N22, BeneVision N1 K202405 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k202414/ 2021-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k202414-braininsight-fda-510k.jpg K202414 - BrainInsight K202414 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hyperfine Research, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k202488/ 2021-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k202488-zsfab-cervical-interbody-system-fda-510k.jpg K202488 - ZSFab Cervical Interbody System K202488 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zsfab, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k202544/ 2021-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k202544-instylla-delivery-kit-fda-510k.jpg K202544 - Instylla Delivery Kit K202544 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Instylla, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k202622/ 2021-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k202622-halyard-lavender-low-dermatitis-fda-510k.jpg K202622 - Halyard Lavender, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and and Fentanyl Citrate K202622 is a FDA 510(k) cleared general hospital medical device. Manufacturer: O&M Halyard, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k203117/ 2021-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k203117-tissuetak-device-fda-510k.jpg K203117 - TissueTak device K203117 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Via Surgical , Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k203345/ 2021-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k203345-multix-impact-fda-510k.jpg K203345 - MULTIX Impact K203345 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k200021/ 2021-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k200021-applied-medical-anoscope-fda-510k.jpg K200021 - Applied Medical Anoscope K200021 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Applied Medical Resources. Cleared Jan 2021. https://www.510kdatabase.net/k200382/ 2021-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k200382-btl-703-2-fda-510k.jpg K200382 - BTL-703-2 K200382 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Btl. Cleared Jan 2021. https://www.510kdatabase.net/k200560/ 2021-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k200560-inbody-fda-510k.jpg K200560 - InBody K200560 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inbody Co., Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k200769/ 2021-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k200769-disposable-endoscope-valves-set-fda-510k.jpg K200769 - Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B K200769 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Wilson Instruments (Sha) Co., Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k200999/ 2021-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k200999-thermidas-ir-system-thir-a615-fda-510k.jpg K200999 - Thermidas IR System (ThIR-A615) K200999 is a FDA 510(k) cleared radiology medical device. Manufacturer: Thermidas Americas, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k202350/ 2021-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k202350-sr-1000-portable-dr-imaging-system-sr-fda-510k.jpg K202350 - SR-1000 Portable DR Imaging System, SR-1000S Portable DR Imaging System K202350 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui). Cleared Jan 2021. https://www.510kdatabase.net/k202491/ 2021-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k202491-disposable-surgical-face-mask-fda-510k.jpg K202491 - Disposable Surgical Face Mask K202491 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Newvalue Medical Products Co., Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k202495/ 2021-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k202495-sirion-lateral-lumbar-interbody-fusion-fda-510k.jpg K202495 - SIRION Lateral Lumbar Interbody Fusion K202495 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Astura Medical, LLC. Cleared Jan 2021. https://www.510kdatabase.net/k202594/ 2021-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k202594-medical-surgical-masks-non-sterile-fda-510k.jpg K202594 - Medical Surgical Masks-Non Sterile K202594 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shandong T&F Nonwoven Co., Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k202810/ 2021-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k202810-autostrut-g2-fda-510k.jpg K202810 - AutoStrut G2 K202810 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthospin, Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k202844/ 2021-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k202844-medical-surgical-gowns-fda-510k.jpg K202844 - Medical Surgical Gowns K202844 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Beijing Biosis Healing Biolog Ical Technology Co., Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k203339/ 2021-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k203339-neolab-clear-aligners-fda-510k.jpg K203339 - NEOLab Clear Aligners K203339 is a FDA 510(k) cleared dental medical device. Manufacturer: New England Ortho Lab, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k203340/ 2021-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k203340-multix-impact-c-fda-510k.jpg K203340 - MULTIX Impact C K203340 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k203465/ 2021-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k203465-ossiofiber-cannulated-trimmable-fda-510k.jpg K203465 - OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design K203465 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OSSIO , Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k203652/ 2021-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k203652-blood-pressure-cuff-u1883su1883d-fda-510k.jpg K203652 - Blood Pressure Cuff, U1883S,U1883D, U1882S, U1882D, U1881S, U1881D, Blood Pressure Cuff, U1885S, U1885D, U1880S, U1880D, U1886S, U1886D, Blood Pressure Cuff, U1869S, U1869D, U1889S, U1889D, U1884S, U1884D, Blood Pressure Cuff, U1710S, U1720S, U1730S,U1740S, U1750S, U1760S, Blood Pressure Cuff, U1770S, U1790s, U1710D, U1720D, U1730D, U1740D K203652 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Jkh USA, LLC. Cleared Jan 2021. https://www.510kdatabase.net/k193273/ 2021-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k193273-insulin-syringe-fda-510k.jpg K193273 - Insulin Syringe K193273 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Promisemed Hangzhou Meditech Co., Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k193497/ 2021-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k193497-fixone-biocomposite-interference-screw-fda-510k.jpg K193497 - Fixone Biocomposite Interference Screw K193497 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aju Pharm Co., Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k200159/ 2021-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k200159-non-contact-infrared-body-thermometer-fda-510k.jpg K200159 - Non-contact Infrared Body Thermometer, model:HTD8823US K200159 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hetaida Technology Co., Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k200298/ 2021-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k200298-abi-instrument-creo-electrosurgical-fda-510k.jpg K200298 - ABI Instrument, Creo Electrosurgical System K200298 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Creo Medical, Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k200491/ 2021-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k200491-bfix-orthopedic-external-fixator-systems-fda-510k.jpg K200491 - Bfix Orthopedic External Fixator Systems K200491 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aike (Shanghai) Medical Instrument Co., Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k200963/ 2021-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k200963-halo-single-loop-microsnare-kit-fda-510k.jpg K200963 - Halo Single-Loop Microsnare Kit K200963 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Argon Medical Devices, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k201114/ 2021-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k201114-bidop-7-fda-510k.jpg K201114 - Bidop 7 K201114 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Koven Technology, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k201872/ 2021-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k201872-neutrart-fda-510k.jpg K201872 - NeutrArt K201872 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Asset Medikal Tasarim As.. Cleared Jan 2021. https://www.510kdatabase.net/k202791/ 2021-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k202791-ihealth-clinical-digital-thermometer-fda-510k.jpg K202791 - iHealth Clinical Digital Thermometer K202791 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Andon Health Co, Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k202857/ 2021-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k202857-clearpath-aligner-fda-510k.jpg K202857 - ClearPath Aligner K202857 is a FDA 510(k) cleared dental medical device. Manufacturer: Clearpath Orthodontics, Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k202719/ 2021-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k202719-disposable-medical-face-masks-fda-510k.jpg K202719 - Disposable Medical Face Masks K202719 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangxi Sanxin Medtec Co., Ltd.. Cleared Jan 2021. https://www.510kdatabase.net/k202880/ 2021-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k202880-j-plasma-precise-flex-handpiece-fda-510k.jpg K202880 - J-Plasma Precise FLEX Handpiece K202880 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Apyx Medical Corporation(Formerly Bovie Medical Corporation). Cleared Jan 2021. https://www.510kdatabase.net/k203561/ 2021-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k203561-choicespine-navigation-system-fda-510k.jpg K203561 - ChoiceSpine Navigation System K203561 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Choice Spine, LLC. Cleared Jan 2021. https://www.510kdatabase.net/k201873/ 2021-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k201873-sparrow-therapy-system-fda-510k.jpg K201873 - Sparrow Therapy System K201873 is a FDA 510(k) cleared neurology medical device. Manufacturer: Spark Biomedical, Inc.. Cleared Jan 2021. https://www.510kdatabase.net/k201239/ 2020-12-31 monthly 0.5 https://www.510kdatabase.net/og-image/k201239-nuera-tight-family-ems-model-fda-510k.jpg K201239 - NuEra Tight Family, EMS Model K201239 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Bios S.R.L.. Cleared Dec 2020. https://www.510kdatabase.net/k201342/ 2020-12-31 monthly 0.5 https://www.510kdatabase.net/og-image/k201342-hanarostent-tracheabronchium-ccc-fda-510k.jpg K201342 - HANAROSTENT Trachea/Bronchium (CCC) K201342 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: M.I. Tech Co., Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k202267/ 2020-12-31 monthly 0.5 https://www.510kdatabase.net/og-image/k202267-sirius-mri-markers-cs-131-preloaded-fda-510k.jpg K202267 - Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles K202267 is a FDA 510(k) cleared radiology medical device. Manufacturer: Isoray Medical, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k202322/ 2020-12-31 monthly 0.5 https://www.510kdatabase.net/og-image/k202322-simsize-fda-510k.jpg K202322 - Sim&Size K202322 is a FDA 510(k) cleared neurology medical device. Manufacturer: Sim&Cure. Cleared Dec 2020. https://www.510kdatabase.net/k202615/ 2020-12-31 monthly 0.5 https://www.510kdatabase.net/og-image/k202615-nordiwell-medical-face-mask-fda-510k.jpg K202615 - Nordiwell Medical Face Mask K202615 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Changzhou Combat Protective Equipment Co., Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k202681/ 2020-12-31 monthly 0.5 https://www.510kdatabase.net/og-image/k202681-promisemed-covered-safety-pen-needle-fda-510k.jpg K202681 - Promisemed Covered Safety Pen Needle K202681 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Promisemed Hangzhou Meditech Co., Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k202706/ 2020-12-31 monthly 0.5 https://www.510kdatabase.net/og-image/k202706-surgical-gown-sterile-surgical-gown-fda-510k.jpg K202706 - Surgical Gown (Sterile), Surgical Gown (Non-sterile) K202706 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k193159/ 2020-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k193159-neuroamp-ii-neuroamp-ii5s-fda-510k.jpg K193159 - NeuroAmp II, NeuroAmp II.5s K193159 is a FDA 510(k) cleared neurology medical device. Manufacturer: Corscience GmbH & Co. KG. Cleared Dec 2020. https://www.510kdatabase.net/k201754/ 2020-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k201754-jianyu-surgical-mask-fda-510k.jpg K201754 - JianYu Surgical Mask K201754 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Jianyu Health Medical Co., Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k201776/ 2020-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k201776-foley-balloon-catheter-for-urology-fda-510k.jpg K201776 - Foley Balloon Catheter for Urology K201776 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Apollon Co., Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k202038/ 2020-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k202038-cryotreq-fda-510k.jpg K202038 - CryoTreQ K202038 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Vitreq BV. Cleared Dec 2020. https://www.510kdatabase.net/k202268/ 2020-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k202268-crossroads-tray-system-fda-510k.jpg K202268 - CrossRoads Tray System K202268 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Crossroads Extremity Systems, LLC. Cleared Dec 2020. https://www.510kdatabase.net/k202372/ 2020-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k202372-upper-arm-electronic-blood-pressure-fda-510k.jpg K202372 - Upper Arm Electronic Blood Pressure Monitor K202372 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Conmo Electronic Company Limited. Cleared Dec 2020. https://www.510kdatabase.net/k202690/ 2020-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k202690-remunity-pump-for-remodulin-fda-510k.jpg K202690 - Remunity Pump for Remodulin (treprostinil) Injection K202690 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Deka Research and Development. Cleared Dec 2020. https://www.510kdatabase.net/k203166/ 2020-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k203166-pentax-medical-ultrasound-upper-gi-fda-510k.jpg K203166 - PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR, PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U K203166 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Pentax of America, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k203239/ 2020-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k203239-arthrex-low-profile-screws-fda-510k.jpg K203239 - Arthrex Low Profile Screws K203239 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k200965/ 2020-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k200965-xr-mx1000-fda-510k.jpg K200965 - XR-MX/1000 K200965 is a FDA 510(k) cleared radiology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k202455/ 2020-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k202455-aixplorermach20-aixplorermach30-fda-510k.jpg K202455 - Aixplorer®MACH20, Aixplorer®MACH30, Supersonic MACH40, Supersonic MACH30 & Supersoinc MACH20 Ultrasonic Diagnostic Systems K202455 is a FDA 510(k) cleared radiology medical device. Manufacturer: Supersonic Imagine. Cleared Dec 2020. https://www.510kdatabase.net/k202456/ 2020-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k202456-m5-recorder-fda-510k.jpg K202456 - M5 Recorder K202456 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Global Instrumentation, LLC. Cleared Dec 2020. https://www.510kdatabase.net/k202699/ 2020-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k202699-e-cath-stim-acc-tsui-fda-510k.jpg K202699 - E-Cath STIM acc. Tsui K202699 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: PAJUNK GmbH Medizintechnologie. Cleared Dec 2020. https://www.510kdatabase.net/k202940/ 2020-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k202940-first-relief-v1-fda-510k.jpg K202940 - First Relief v1 K202940 is a FDA 510(k) cleared neurology medical device. Manufacturer: Dyansys, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k203137/ 2020-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k203137-venue-fit-fda-510k.jpg K203137 - Venue Fit K203137 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared Dec 2020. https://www.510kdatabase.net/k203219/ 2020-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k203219-trevo-xp-provue-retriever-and-trevo-fda-510k.jpg K203219 - Trevo XP ProVue Retriever and Trevo NXT™ ProVue Retriever K203219 is a FDA 510(k) cleared neurology medical device. Manufacturer: Stryker Neurovascular. Cleared Dec 2020. https://www.510kdatabase.net/k203508/ 2020-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k203508-briefcase-fda-510k.jpg K203508 - BriefCase K203508 is a FDA 510(k) cleared radiology medical device. Manufacturer: Aidoc Medical , Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k203511/ 2020-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k203511-baby-gorillagorilla-plating-system-fda-510k.jpg K203511 - Baby Gorilla/Gorilla Plating System K203511 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paragon 28, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k200321/ 2020-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k200321-novaerus-nv1050-fda-510k.jpg K200321 - Novaerus NV1050 K200321 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Novaerus Us, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k200458/ 2020-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k200458-tailored-c-cervical-interbody-fusion-fda-510k.jpg K200458 - Tailored-C Cervical Interbody Fusion System K200458 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Bespoke Technologies. Cleared Dec 2020. https://www.510kdatabase.net/k200968/ 2020-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k200968-abc33l-abc35l-abc37l-abc39l-abc33r-fda-510k.jpg K200968 - ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R K200968 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Insung Medical Co., Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k200970/ 2020-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k200970-self-contained-biological-indicator-fda-510k.jpg K200970 - Self-Contained Biological Indicator K200970 is a FDA 510(k) cleared general hospital medical device. Manufacturer: True Indicating, LLC. Cleared Dec 2020. https://www.510kdatabase.net/k201781/ 2020-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k201781-uni-fuze-p-bone-putty-fda-510k.jpg K201781 - Uni-FuZe-P Bone Putty K201781 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zavation Medical Products, LLC. Cleared Dec 2020. https://www.510kdatabase.net/k201800/ 2020-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k201800-portable-dental-x-ray-nr-f350-cs-2400p-fda-510k.jpg K201800 - Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X) K201800 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nanoray Co., Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k202248/ 2020-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k202248-attune-revision-sleeve-lps-femoral-fda-510k.jpg K202248 - Attune Revision Sleeve LPS Femoral Adaptors K202248 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Ireland UC. Cleared Dec 2020. https://www.510kdatabase.net/k202454/ 2020-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k202454-smart-space-shoulder-system-fda-510k.jpg K202454 - Smart SPACE Shoulder System K202454 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Techmah Medical, LLC. Cleared Dec 2020. https://www.510kdatabase.net/k202730/ 2020-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k202730-quadra-p-fda-510k.jpg K202730 - Quadra-P K202730 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Dec 2020. https://www.510kdatabase.net/k203062/ 2020-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k203062-optiflux-series-of-dialyzers-f160nr-fda-510k.jpg K203062 - Optiflux Series of Dialyzers F160NR, F180NR, F200NR K203062 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC. Cleared Dec 2020. https://www.510kdatabase.net/k193419/ 2020-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k193419-mbt-sepsityper-fda-510k.jpg K193419 - MBT Sepsityper K193419 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bruker Daltonik GmbH. Cleared Dec 2020. https://www.510kdatabase.net/k201747/ 2020-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k201747-8-ch-electroencephalography-amplifier-fda-510k.jpg K201747 - 8-CH Electroencephalography Amplifier K201747 is a FDA 510(k) cleared neurology medical device. Manufacturer: Hipposcreen Neurotech Corp.. Cleared Dec 2020. https://www.510kdatabase.net/k202485/ 2020-12-25 monthly 0.5 https://www.510kdatabase.net/og-image/k202485-impact-version-4-fda-510k.jpg K202485 - ImPACT Version 4 K202485 is a FDA 510(k) cleared neurology medical device. Manufacturer: Impact Applications, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k200422/ 2020-12-24 monthly 0.5 https://www.510kdatabase.net/og-image/k200422-image-quality-analyzer-iqa-fda-510k.jpg K200422 - Image Quality Analyzer (IQA) K200422 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Visionquest Biomedical, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k200426/ 2020-12-24 monthly 0.5 https://www.510kdatabase.net/og-image/k200426-acute-dual-lumen-hemodialysis-catheter-fda-510k.jpg K200426 - Acute Dual Lumen Hemodialysis Catheter K200426 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Health Line International Corporation. Cleared Dec 2020. https://www.510kdatabase.net/k203544/ 2020-12-24 monthly 0.5 https://www.510kdatabase.net/og-image/k203544-ultrapulse-surgical-and-aesthetic-co2-fda-510k.jpg K203544 - UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories K203544 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lumenis, Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k192073/ 2020-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k192073-helix-genetic-health-risk-app-for-late-fda-510k.jpg K192073 - Helix Genetic Health Risk App for late-onset Alzheimer’s disease K192073 is a FDA 510(k) cleared immunology medical device. Manufacturer: Helix Opco, LLC. Cleared Dec 2020. https://www.510kdatabase.net/k193670/ 2020-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k193670-sc-haemodialysis-machine-sc-dialysate-fda-510k.jpg K193670 - SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set K193670 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quanta Dialysis Technologies, Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k200610/ 2020-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k200610-customized-contour-implant-fda-510k.jpg K200610 - Customized Contour Implant K200610 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Implantech Associates, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k200631/ 2020-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k200631-deroyal-temperature-monitoring-probe-fda-510k.jpg K200631 - DeRoyal Temperature Monitoring Probe K200631 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Deroyal Industries, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k200697/ 2020-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k200697-atricure-cryoice-cryo-ablation-probe-fda-510k.jpg K200697 - AtriCure cryoICE cryo-ablation probe (Cryo2), AAtriCure cryoICE cryoSPHERE cryoablation probe (CryoS, CryoS-L) K200697 is a FDA 510(k) cleared neurology medical device. Manufacturer: AtriCure, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k201458/ 2020-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k201458-scrambler-therapy-technology-model-st-5a-fda-510k.jpg K201458 - Scrambler Therapy Technology (Model ST-5A) K201458 is a FDA 510(k) cleared neurology medical device. Manufacturer: Delta International Services & Logistics S.R.L. Cleared Dec 2020. https://www.510kdatabase.net/k201604/ 2020-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k201604-plasdent-disposable-barrier-sleeves-fda-510k.jpg K201604 - Plasdent Disposable Barrier Sleeves and Barrier Film K201604 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Plasdent Corporation. Cleared Dec 2020. https://www.510kdatabase.net/k202061/ 2020-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k202061-medical-face-mask-fda-510k.jpg K202061 - Medical Face mask K202061 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Province Jianerkang Medical Dressing Co., Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k202237/ 2020-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k202237-locking-device-fda-510k.jpg K202237 - Locking device K202237 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hangzhou AGS MedTech Co., Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k202320/ 2020-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k202320-cirq-robotic-alignment-module-cirq-fda-510k.jpg K202320 - CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal, Cirq Robotic Alignment Cranial and Spine, CIRQ Robotic Alignment Cranial and Spine System K202320 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Brainlab AG. Cleared Dec 2020. https://www.510kdatabase.net/k202353/ 2020-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k202353-sr-2300-portable-dr-imaging-system-sr-fda-510k.jpg K202353 - SR-2300 Portable DR Imaging System, SR-2300S Portable DR Imaging System K202353 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui). Cleared Dec 2020. https://www.510kdatabase.net/k202431/ 2020-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k202431-controlrad-select-model-z-fda-510k.jpg K202431 - ControlRad Select Model Z K202431 is a FDA 510(k) cleared radiology medical device. Manufacturer: Controlrad, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k202526/ 2020-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k202526-omnitom-elite-fda-510k.jpg K202526 - OmniTom Elite K202526 is a FDA 510(k) cleared radiology medical device. Manufacturer: Neurologica Corporation, A Subsidiary of Samsung Electronics. Cleared Dec 2020. https://www.510kdatabase.net/k202637/ 2020-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k202637-f3d-corpectomy-system-fda-510k.jpg K202637 - F3D Corpectomy System K202637 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corelink, LLC. Cleared Dec 2020. https://www.510kdatabase.net/k202882/ 2020-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k202882-affinity-fda-510k.jpg K202882 - Affinity K202882 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hermes Medical Solutions AB. Cleared Dec 2020. https://www.510kdatabase.net/k203026/ 2020-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k203026-altivate-anatomic-pegged-glenoid-with-fda-510k.jpg K203026 - AltiVate® Anatomic Pegged Glenoid with Markers K203026 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Encore Medical, L.P.. Cleared Dec 2020. https://www.510kdatabase.net/k203207/ 2020-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k203207-omnia-medical-tibrid-sa-fda-510k.jpg K203207 - Omnia Medical TiBrid-SA K203207 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Omnia Medical, LLC. Cleared Dec 2020. https://www.510kdatabase.net/k203257/ 2020-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k203257-lubi-water-based-personal-lubricant-fda-510k.jpg K203257 - LUBi Water Based Personal Lubricant K203257 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Boya Biotechnology Co., Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k203467/ 2020-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k203467-wishbone-medical-plate-and-screw-system-fda-510k.jpg K203467 - WishBone Medical Plate and Screw System K203467 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wishbone Medical, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k203540/ 2020-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k203540-bridge-occlusion-balloon-fda-510k.jpg K203540 - Bridge Occlusion Balloon K203540 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Spectranetics, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/den190035/ 2020-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/den190035-helix-laboratory-platform-fda-510k.jpg DEN190035 - Helix Laboratory Platform DEN190035 is a FDA 510(k) cleared medical genetics medical device. Manufacturer: Helix Opco, LLC. Cleared Dec 2020. https://www.510kdatabase.net/den200016/ 2020-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/den200016-endorotor-device-fda-510k.jpg DEN200016 - EndoRotor Device DEN200016 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Interscope, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k200473/ 2020-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k200473-soloasisst-ii-voice-control-fda-510k.jpg K200473 - SoloAsisst II, Voice Control K200473 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aktormed GmbH. Cleared Dec 2020. https://www.510kdatabase.net/k200908/ 2020-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k200908-ismile-fda-510k.jpg K200908 - iSMILE K200908 is a FDA 510(k) cleared dental medical device. Manufacturer: 3D Diagnostix, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k201036/ 2020-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k201036-planimax-orthodontic-software-fda-510k.jpg K201036 - PlaniMax Orthodontic Software K201036 is a FDA 510(k) cleared dental medical device. Manufacturer: Choice Biotech, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k201287/ 2020-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k201287-impulse-interbody-fusion-system-fda-510k.jpg K201287 - Impulse Interbody Fusion System K201287 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Degen Medical. Cleared Dec 2020. https://www.510kdatabase.net/k201489/ 2020-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k201489-traveler38-0038-stylet-portal-vein-fda-510k.jpg K201489 - Traveler38 0.038 Stylet Portal Vein Access Set, Traveler21 21ga Needle Portal Vein Access Set, Traveler16 16ga Needle Portal Vein Access set K201489 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Argon Medical Devices, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k201491/ 2020-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k201491-neodent-implant-system-zirconia-fda-510k.jpg K201491 - Neodent Implant System - Zirconia Implant System K201491 is a FDA 510(k) cleared dental medical device. Manufacturer: Jjgc Industria E Comercio DE Materiais Dentarios S.A.. Cleared Dec 2020. https://www.510kdatabase.net/k201643/ 2020-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k201643-choicespine-tiger-shark-cervical-fda-510k.jpg K201643 - ChoiceSpine Tiger Shark Cervical Spacer System K201643 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Choice Spine, LLC. Cleared Dec 2020. https://www.510kdatabase.net/k201705/ 2020-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k201705-revene-thrombectomy-catheter-fda-510k.jpg K201705 - ReVene Thrombectomy Catheter K201705 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vetex Medical, Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k201707/ 2020-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k201707-opallis-opallis-flow-fda-510k.jpg K201707 - Opallis, Opallis Flow K201707 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentscare Ltda. Cleared Dec 2020. https://www.510kdatabase.net/k201910/ 2020-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k201910-eztrack-fda-510k.jpg K201910 - EZTrack K201910 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neurologic, LLC. Cleared Dec 2020. https://www.510kdatabase.net/k202159/ 2020-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k202159-actitens-fda-510k.jpg K202159 - actiTENS K202159 is a FDA 510(k) cleared neurology medical device. Manufacturer: Sublimed. Cleared Dec 2020. https://www.510kdatabase.net/k202211/ 2020-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k202211-disposable-medical-surgical-face-masks-fda-510k.jpg K202211 - Disposable Medical Surgical Face Masks K202211 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guangdong Kaidi Garments Co.,Ltd. Cleared Dec 2020. https://www.510kdatabase.net/k202229/ 2020-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k202229-ai-metrics-fda-510k.jpg K202229 - AI Metrics K202229 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ai Metrics, LLC. Cleared Dec 2020. https://www.510kdatabase.net/k202298/ 2020-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k202298-lucent-xp-lucent-xp-curved-fda-510k.jpg K202298 - Lucent XP, Lucent XP Curved K202298 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinal Elements, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k202348/ 2020-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k202348-external-remote-controller-erc-4p-fda-510k.jpg K202348 - External Remote Controller ERC 4P K202348 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nuvasive Specialized Orthopedics, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k202820/ 2020-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k202820-australis-anterior-lumbar-cage-system-fda-510k.jpg K202820 - Australis Anterior Lumbar Cage System K202820 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Prism Surgical Designs Pty, Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k202849/ 2020-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k202849-everyway-analog-otc-tens-model-n103an302-fda-510k.jpg K202849 - Everyway Analog OTC TENS, model N103A/N302 K202849 is a FDA 510(k) cleared neurology medical device. Manufacturer: Everyway Medical Instruments Co.,Ltd. Cleared Dec 2020. https://www.510kdatabase.net/k202968/ 2020-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k202968-da-vinci-sp-surgical-system-fda-510k.jpg K202968 - Da Vinci SP Surgical System K202968 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k202974/ 2020-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k202974-dentek-fresh-protect-dental-guard-fda-510k.jpg K202974 - DenTek Fresh Protect Dental Guard K202974 is a FDA 510(k) cleared dental medical device. Manufacturer: Medtech Products, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k203066/ 2020-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k203066-coolief-cooled-radiofrequency-kit-fda-510k.jpg K203066 - COOLIEF Cooled Radiofrequency Kit Advanced K203066 is a FDA 510(k) cleared neurology medical device. Manufacturer: Avanos Medical, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k203281/ 2020-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k203281-mobile-imagingring-system-irm-loop-x-fda-510k.jpg K203281 - Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X K203281 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medphoton GmbH. Cleared Dec 2020. https://www.510kdatabase.net/k203437/ 2020-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k203437-serranator-pta-serration-balloon-fda-510k.jpg K203437 - Serranator PTA Serration Balloon Catheter K203437 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cagent Vascular, LLC. Cleared Dec 2020. https://www.510kdatabase.net/k203447/ 2020-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k203447-itotal-identity-cruciate-retaining-cr-fda-510k.jpg K203447 - iTotal Identity Cruciate Retaining (CR) Total Knee Replacement, iTotal Identity Posterior Stabilizing (PS) Total Knee Replacement K203447 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Conformis, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k203452/ 2020-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k203452-nano-fortifix-system-fda-510k.jpg K203452 - Nano FortiFix® System K203452 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nanovis, LLC. Cleared Dec 2020. https://www.510kdatabase.net/k203476/ 2020-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k203476-capere-thrombectomy-system-fda-510k.jpg K203476 - CAPERE Thrombectomy System K203476 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vascular Medcure, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k203504/ 2020-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k203504-cios-flow-fda-510k.jpg K203504 - Cios Flow K203504 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k203552/ 2020-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k203552-rapid-reboot-fda-510k.jpg K203552 - Rapid Reboot K203552 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Rapid Reboot Recovery Products, LLC. Cleared Dec 2020. https://www.510kdatabase.net/k192308/ 2020-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k192308-wus-electrical-scooter-fda-510k.jpg K192308 - Wu's Electrical Scooter K192308 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Wu'S Tech Co., Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k201113/ 2020-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k201113-resascope-rs-01b-fda-510k.jpg K201113 - Resascope RS-01/B K201113 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Advanced Medical Systems Group Srl. Cleared Dec 2020. https://www.510kdatabase.net/k201996/ 2020-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k201996-monocryl-plus-antibacterial-suture-fda-510k.jpg K201996 - Monocryl Plus Antibacterial Suture K201996 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k202782/ 2020-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k202782-num-vapocoolant-fda-510k.jpg K202782 - num Vapocoolant K202782 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: 623 Medical, LLC. Cleared Dec 2020. https://www.510kdatabase.net/k202979/ 2020-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k202979-mr-egometer-pedal-mr-ergometer-fda-510k.jpg K202979 - MR Egometer Pedal, MR Ergometer Push/Pull, MR Ergometer Up/Down, MR Ergometer Dorsal Ankle Flex, MR Ergometer Pedal Ultra K202979 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Lode B.V.. Cleared Dec 2020. https://www.510kdatabase.net/k203445/ 2020-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k203445-trigon-ha-stand-alone-wedge-fixation-fda-510k.jpg K203445 - Trigon HA Stand-Alone Wedge Fixation System K203445 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nvision Biomedical Technologies, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k201077/ 2020-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k201077-strados-remote-electronic-stethoscope-fda-510k.jpg K201077 - Strados Remote Electronic Stethoscope Platform (RESP) K201077 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Strados Labs. Cleared Dec 2020. https://www.510kdatabase.net/k203178/ 2020-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k203178-flexitouch-plus-system-fda-510k.jpg K203178 - Flexitouch Plus System K203178 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Tactile Systems Technology, Inc. (Dba Tactile Medical). Cleared Dec 2020. https://www.510kdatabase.net/k202005/ 2020-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k202005-novofine-plus-32g-tip-x-4-mm-fda-510k.jpg K202005 - NovoFine Plus 32G Tip x 4 mm K202005 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Novo Nordisk, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k202668/ 2020-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k202668-signature-latex-and-signature-latex-fda-510k.jpg K202668 - Signature Latex and Signature Latex Micro, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm2 per Glove of Extractable Protein K202668 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k191978/ 2020-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k191978-fever-garde-fda-510k.jpg K191978 - Fever Garde K191978 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hubdic Co., Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k201075/ 2020-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k201075-bd-insyte-autoguard-shielded-iv-fda-510k.jpg K201075 - BD Insyte Autoguard Shielded IV Catheter, BD Insyte Autoguard BC Shielded IV Catheter, BD Insyte Autoguard BC Pro Shielded IV Catheter K201075 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson and Company. Cleared Dec 2020. https://www.510kdatabase.net/k201185/ 2020-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k201185-microinr-system-fda-510k.jpg K201185 - microINR System K201185 is a FDA 510(k) cleared hematology medical device. Manufacturer: Iline Microsystems, S.L.. Cleared Dec 2020. https://www.510kdatabase.net/k201250/ 2020-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k201250-squeez-software-fda-510k.jpg K201250 - SQuEEZ Software K201250 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cardiowise, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k201555/ 2020-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k201555-echogo-pro-fda-510k.jpg K201555 - EchoGo Pro K201555 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ultromics, Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k201606/ 2020-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k201606-lacrijet-fda-510k.jpg K201606 - LacriJet® K201606 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Fci (France Chirurgie Instrumentation) Sas. Cleared Dec 2020. https://www.510kdatabase.net/k201980/ 2020-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k201980-infrared-thermometer-fda-510k.jpg K201980 - Infrared Thermometer K201980 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Contec Medical Systems Co.,Ltd. Cleared Dec 2020. https://www.510kdatabase.net/k202006/ 2020-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k202006-ent-plasma-wands-turbinator-wand-fda-510k.jpg K202006 - ENT Plasma Wands, Turbinator Wand, Werewolf Irrigation Tube Set, Werewolf ENT Adapter, Werewolf Coblation System K202006 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: ArthroCare Corporation. Cleared Dec 2020. https://www.510kdatabase.net/k202026/ 2020-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k202026-blue-sky-bio-cad-cam-abutments-fda-510k.jpg K202026 - Blue Sky Bio CAD-CAM Abutments K202026 is a FDA 510(k) cleared dental medical device. Manufacturer: Blue Sky Bio, LLC. Cleared Dec 2020. https://www.510kdatabase.net/k202345/ 2020-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k202345-flowtriever-retrievalaspiration-system-fda-510k.jpg K202345 - FlowTriever Retrieval/Aspiration System K202345 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inari Medical. Cleared Dec 2020. https://www.510kdatabase.net/k202361/ 2020-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k202361-ultraslim-digital-ultrasmooth-digital-fda-510k.jpg K202361 - UltraSlim Digital, UltraSmooth Digital K202361 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ward Photonics, LLC. Cleared Dec 2020. https://www.510kdatabase.net/k202412/ 2020-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k202412-clearrt-helical-kvct-for-the-radixact-fda-510k.jpg K202412 - ClearRT Helical kVCT for the Radixact Treatment Delivery System K202412 is a FDA 510(k) cleared radiology medical device. Manufacturer: Accuray Incorporated. Cleared Dec 2020. https://www.510kdatabase.net/k202749/ 2020-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k202749-adapt-for-gamma3-fda-510k.jpg K202749 - ADAPT for Gamma3 K202749 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker GmbH. Cleared Dec 2020. https://www.510kdatabase.net/k202812/ 2020-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k202812-identiti-cervical-standalone-interbody-fda-510k.jpg K202812 - IdentiTi Cervical Standalone Interbody System K202812 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k203125/ 2020-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k203125-invictus-oct-spinal-fixation-system-fda-510k.jpg K203125 - Invictus™ OCT Spinal Fixation System K203125 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k203126/ 2020-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k203126-s10-kirra-fda-510k.jpg K203126 - S10 Kirra K203126 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Resmed Pty , Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k203162/ 2020-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k203162-advanix-biliary-stent-with-naviflex-rx-fda-510k.jpg K203162 - Advanix Biliary Stent with NaviFlex RX Delivery System K203162 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Dec 2020. https://www.510kdatabase.net/k203172/ 2020-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k203172-mosaiq-oncology-information-system-fda-510k.jpg K203172 - MOSAIQ Oncology Information System K203172 is a FDA 510(k) cleared radiology medical device. Manufacturer: Elekta Solutions AB. Cleared Dec 2020. https://www.510kdatabase.net/k203461/ 2020-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k203461-aesculap-caiman-12-seal-and-cut-fda-510k.jpg K203461 - Aesculap Caiman 12 Seal and Cut Technology System K203461 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k203551/ 2020-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k203551-alphenix-infx-8000vb-s-v91-fda-510k.jpg K203551 - Alphenix, INFX-8000V/B, /S, V9.1 K203551 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Dec 2020. https://www.510kdatabase.net/k190217/ 2020-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k190217-aidite-pmma-fda-510k.jpg K190217 - Aidite PMMA K190217 is a FDA 510(k) cleared dental medical device. Manufacturer: Aidite (Qinhuangdao) Technology Co., Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k192770/ 2020-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k192770-s-dispensing-line-fda-510k.jpg K192770 - S dispensing line K192770 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Aea Srl. Cleared Dec 2020. https://www.510kdatabase.net/k200264/ 2020-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k200264-exofin-high-viscosity-topical-skin-fda-510k.jpg K200264 - Exofin High Viscosity Topical Skin Adhesive K200264 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Chemence Medical, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k200342/ 2020-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k200342-single-use-grasping-forceps-fg-214p-fda-510k.jpg K200342 - Single Use Grasping Forceps FG-214P, Single Use Grasping Forceps FG-220P, Single Use Grasping Forceps FG-226C, Single Use Grasping Forceps FG-232L, Single Use Grasping Forceps FG-804L K200342 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Dec 2020. https://www.510kdatabase.net/k200346/ 2020-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k200346-wrist-type-blood-pressure-monitor-fda-510k.jpg K200346 - Wrist Type Blood Pressure Monitor K200346 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Avita Corporation. Cleared Dec 2020. https://www.510kdatabase.net/k200730/ 2020-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k200730-pjur-woman-nude-pjur-med-sensitive-glide-fda-510k.jpg K200730 - pjur WOMAN Nude pjur med SENSITIVE glide K200730 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Pjur Group Luxembourg S.A.. Cleared Dec 2020. https://www.510kdatabase.net/k200857/ 2020-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k200857-electric-wheelchair-model-s7012-fda-510k.jpg K200857 - Electric wheelchair (Model: S7012) K200857 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Dongguan Prestige Sporting Goods Co., Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k201081/ 2020-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k201081-altatrack-equipment-altatrack-fda-510k.jpg K201081 - AltaTrack equipment, AltaTrack Guidewire, AltaTrack Catheter K201081 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Philips Medical System Nederland B.V.. Cleared Dec 2020. https://www.510kdatabase.net/k201165/ 2020-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k201165-in-ka-percutaneous-balloon-dilatation-fda-510k.jpg K201165 - In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath K201165 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Coloplast Corp.. Cleared Dec 2020. https://www.510kdatabase.net/k201594/ 2020-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k201594-primelase-excellence-fda-510k.jpg K201594 - Primelase Excellence K201594 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: High Technology Products S.L.U. Cleared Dec 2020. https://www.510kdatabase.net/k201905/ 2020-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k201905-smr-140-reverse-humeral-body-fda-510k.jpg K201905 - SMR 140° Reverse Humeral Body K201905 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Lima Corporate S.P.A.. Cleared Dec 2020. https://www.510kdatabase.net/k201919/ 2020-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k201919-blue-sky-bio-tad-fda-510k.jpg K201919 - Blue Sky Bio TAD K201919 is a FDA 510(k) cleared dental medical device. Manufacturer: Blue Sky Bio, LLC. Cleared Dec 2020. https://www.510kdatabase.net/k202925/ 2020-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k202925-karl-storz-icg-imaging-system-fda-510k.jpg K202925 - KARL STORZ ICG Imaging System K202925 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k203004/ 2020-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k203004-acist-cvi1-contrast-delivery-system-fda-510k.jpg K203004 - ACIST CVi1 Contrast Delivery System, ACIST CVi Contrast Delivery System K203004 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Acist Medical Systems, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k203163/ 2020-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k203163-arx-illiac-spinal-screw-system-fda-510k.jpg K203163 - ARx Illiac Spinal Screw System K203163 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k203222/ 2020-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k203222-perla-tl-posterior-osteosynthesis-system-fda-510k.jpg K203222 - PERLA TL Posterior Osteosynthesis System K203222 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spineart. Cleared Dec 2020. https://www.510kdatabase.net/k203303/ 2020-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k203303-emprint-sx-ablation-platform-with-fda-510k.jpg K203303 - Emprint SX Ablation Platform with Thermosphere Technology K203303 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien, LLC. Cleared Dec 2020. https://www.510kdatabase.net/k200291/ 2020-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k200291-creed-cannulated-screws-fda-510k.jpg K200291 - CREED™ Cannulated Screws K200291 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Glw Medical, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k200549/ 2020-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k200549-lucero-medical-cervical-cage-system-fda-510k.jpg K200549 - Lucero Medical Cervical Cage System K200549 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Lucero Medical, LLC. Cleared Dec 2020. https://www.510kdatabase.net/k201031/ 2020-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k201031-nrfit-caps-male-and-female-neuraxial-fda-510k.jpg K201031 - NRFit® Caps, Male and Female Neuraxial Tip Caps K201031 is a FDA 510(k) cleared general hospital medical device. Manufacturer: International Medical Industries, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k201213/ 2020-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k201213-pasteur-pipette-3ml-pasteur-pipette-1ml-fda-510k.jpg K201213 - Pasteur Pipette 3mL, Pasteur Pipette 1mL K201213 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Hertart Aps. Cleared Dec 2020. https://www.510kdatabase.net/k201509/ 2020-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k201509-disposable-stone-extraction-basket-fda-510k.jpg K201509 - Disposable Stone Extraction basket K201509 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hangzhou AGS MedTech Co., Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k202028/ 2020-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k202028-dermalux-flex-md-fda-510k.jpg K202028 - dermalux Flex MD K202028 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesthetic Technology, Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k202029/ 2020-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k202029-medical-surgical-mask-fda-510k.jpg K202029 - Medical Surgical Mask K202029 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Beijing Biosis Healing Biolog Ical Technology Co., Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k202095/ 2020-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k202095-creodent-solidex-customized-abutment-fda-510k.jpg K202095 - CreoDent Solidex Customized Abutment and Screw K202095 is a FDA 510(k) cleared dental medical device. Manufacturer: Creodent Prosthetics, Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k202289/ 2020-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k202289-reunion-reversible-fracture-system-rfx-fda-510k.jpg K202289 - ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) K202289 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker GmbH. Cleared Dec 2020. https://www.510kdatabase.net/k203097/ 2020-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k203097-hydromark-breast-biopsy-site-markers-fda-510k.jpg K203097 - HydroMARK Breast Biopsy Site Markers K203097 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Devicor Medical Products, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k203180/ 2020-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k203180-arthrex-dynanite-nitinol-staples-fda-510k.jpg K203180 - Arthrex DynaNite Nitinol Staples K203180 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k203349/ 2020-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k203349-longeviti-clearfit-cranial-implant-fda-510k.jpg K203349 - Longeviti ClearFit Cranial Implant K203349 is a FDA 510(k) cleared neurology medical device. Manufacturer: Longeviti Neuro Solutions, LLC. Cleared Dec 2020. https://www.510kdatabase.net/k203414/ 2020-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k203414-depuy-synthes-27mm-va-lcp-clavicle-fda-510k.jpg K203414 - DePuy Synthes 2.7mm VA LCP Clavicle Plate System, DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System K203414 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Synthes. Cleared Dec 2020. https://www.510kdatabase.net/den200035/ 2020-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/den200035-bear-bridge-enhanced-acl-repair-implant-fda-510k.jpg DEN200035 - BEAR (Bridge-Enhanced ACL Repair) Implant DEN200035 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Miach Orthopaedics, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k192709/ 2020-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k192709-fixone-all-suture-anchor-fda-510k.jpg K192709 - Fixone All Suture Anchor K192709 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aju Pharm Co., Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k200971/ 2020-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k200971-308nm-excimer-system-fda-510k.jpg K200971 - 308nm Excimer System K200971 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Xuzhou Kernel Medical Equipment Co., Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k201755/ 2020-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k201755-waveform-l-interbody-system-waveform-fda-510k.jpg K201755 - WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody System K201755 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared Dec 2020. https://www.510kdatabase.net/k201808/ 2020-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k201808-x-tack-endoscopic-helix-tacking-system-fda-510k.jpg K201808 - X-Tack Endoscopic HeliX Tacking System K201808 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Apollo Endosurgery, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k202226/ 2020-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k202226-lim-precision-steerable-ts-steerable-fda-510k.jpg K202226 - Lim Precision Steerable TS, Steerable Sheath, Dilator K202226 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Keystone Heart, Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k202230/ 2020-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k202230-nexxt-matrixx-stand-alone-alif-system-fda-510k.jpg K202230 - NEXXT MATRIXX Stand Alone ALIF System K202230 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nexxt Spine, LLC. Cleared Dec 2020. https://www.510kdatabase.net/k202337/ 2020-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k202337-pulsed-electromagnetic-field-wrap-fda-510k.jpg K202337 - Pulsed electromagnetic field wrap K202337 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Hi-Dow International, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k202601/ 2020-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k202601-single-use-sterile-medical-laser-fiber-fda-510k.jpg K202601 - Single-use Sterile medical laser fiber K202601 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Realton (Suzhou) Medical Technology Co., Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k202698/ 2020-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k202698-prefilled-syringe-fda-510k.jpg K202698 - Prefilled Syringe K202698 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hangzhou Primecare Medical Co., Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k202827/ 2020-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k202827-308nm-excimer-uv-light-skin-therapy-fda-510k.jpg K202827 - 308nm Excimer UV-light Skin Therapy System K202827 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Gsd Tech Co., Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k203383/ 2020-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k203383-philips-avent-double-electric-breast-fda-510k.jpg K203383 - Philips Avent Double electric breast pump Advanced SCF394/61, Philips Avent Double electric breast pump Advanced SCF394/62 K203383 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Philips Consumer Lifestyle - Innovation Site Eindhoven. Cleared Dec 2020. https://www.510kdatabase.net/k203401/ 2020-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k203401-neocis-guidance-system-ngs-with-fda-510k.jpg K203401 - Neocis Guidance System (NGS) with Patient Splints (EPS) K203401 is a FDA 510(k) cleared dental medical device. Manufacturer: Neocis, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k200374/ 2020-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k200374-columbus-guidewire-fda-510k.jpg K200374 - Columbus Guidewire K200374 is a FDA 510(k) cleared neurology medical device. Manufacturer: Rapid Medical , Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k201084/ 2020-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k201084-physica-system-fda-510k.jpg K201084 - Physica system K201084 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Lima Corporate S.P.A.. Cleared Dec 2020. https://www.510kdatabase.net/k201284/ 2020-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k201284-sterile-hypodermic-syringe-for-single-fda-510k.jpg K201284 - Sterile Hypodermic Syringe for Single Use, with/without needle, luer/luer-lock, Sterile Insulin Syringe for Single Use, with needle, Sterile Hypodermic needle for Single use K201284 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Set Medikal Sanayi VE Ticaret Anonim Sirketi. Cleared Dec 2020. https://www.510kdatabase.net/k201495/ 2020-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k201495-maxxi-flow-sensor-fda-510k.jpg K201495 - Maxxi Flow Sensor K201495 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Neurovirtual USA, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k201629/ 2020-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k201629-medical-face-mask-fda-510k.jpg K201629 - Medical Face Mask K201629 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shandong Shengquan New Material Co., Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k201735/ 2020-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k201735-pladuo-system-fda-510k.jpg K201735 - PlaDuo System K201735 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: ShenB Co., Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k202222/ 2020-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k202222-irrisept-wound-debridement-and-fda-510k.jpg K202222 - Irrisept Wound Debridement and Cleansing System K202222 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Irrimax Corporation. Cleared Dec 2020. https://www.510kdatabase.net/k202324/ 2020-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k202324-fingertip-pulse-oximeter-fda-510k.jpg K202324 - Fingertip Pulse Oximeter K202324 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Bsx Technology Electronics Co., Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k202467/ 2020-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k202467-disposable-powered-articulating-fda-510k.jpg K202467 - Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads K202467 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Fengh Medical Co., Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k202610/ 2020-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k202610-ventrax-delivery-system-fda-510k.jpg K202610 - Ventrax Delivery System K202610 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k202641/ 2020-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k202641-dnarna-shield-collection-tube-fda-510k.jpg K202641 - DNA/RNA Shield Collection Tube K202641 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Zymo Research. Cleared Dec 2020. https://www.510kdatabase.net/k202657/ 2020-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k202657-javelin-tailors-bunion-fixation-system-fda-510k.jpg K202657 - Javelin Tailor's Bunion Fixation System K202657 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nvision Biomedical Technologies, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k192916/ 2020-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k192916-nova-lite-dapi-dsdna-crithidia-fda-510k.jpg K192916 - NOVA Lite DAPI dsDNA Crithidia luciliae Kit K192916 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k200940/ 2020-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k200940-beamsite-fda-510k.jpg K200940 - BeamSite K200940 is a FDA 510(k) cleared radiology medical device. Manufacturer: Doseoptics, LLC. Cleared Dec 2020. https://www.510kdatabase.net/k200996/ 2020-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k200996-3m-attest-rapid-readout-biological-fda-510k.jpg K200996 - 3M Attest Rapid Readout Biological Indicator K200996 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Dec 2020. https://www.510kdatabase.net/k201046/ 2020-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k201046-automated-ankle-brachial-pressure-fda-510k.jpg K201046 - Automated ankle brachial pressure index measuring device, MESI mTABLET system K201046 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k201354/ 2020-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k201354-tens-pms-fda-510k.jpg K201354 - TENS & PMS K201354 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Hong Qiangxing (Shenzhen) Electronics Limited. Cleared Dec 2020. https://www.510kdatabase.net/k201658/ 2020-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k201658-hamilton-c6-fda-510k.jpg K201658 - Hamilton-C6 K201658 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Hamilton Medical AG. Cleared Dec 2020. https://www.510kdatabase.net/k202275/ 2020-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k202275-corpath-grx-system-fda-510k.jpg K202275 - CorPath GRX System K202275 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Corindus, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k202471/ 2020-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k202471-exgraft-eptfe-vascular-graft-exgraft-fda-510k.jpg K202471 - exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft K202471 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Peca Labs. Cleared Dec 2020. https://www.510kdatabase.net/k202684/ 2020-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k202684-gmk-total-knee-system-tinbn-coating-fda-510k.jpg K202684 - GMK Total Knee System - TiNbN Coating K202684 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Dec 2020. https://www.510kdatabase.net/k203090/ 2020-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k203090-eleos-limb-salvage-system-featuring-fda-510k.jpg K203090 - ELEOS Limb Salvage System featuring BIOGRIP K203090 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Onkos Surgical. Cleared Dec 2020. https://www.510kdatabase.net/k203458/ 2020-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k203458-3m-comply-hydrogen-peroxide-chemical-fda-510k.jpg K203458 - 3M Comply Hydrogen Peroxide Chemical Indicator 1248 K203458 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Dec 2020. https://www.510kdatabase.net/k203487/ 2020-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k203487-drakon-and-sequre-microcatheters-fda-510k.jpg K203487 - Drakon and Sequre Microcatheters K203487 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Accurate Medical Therapeutics, Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k192798/ 2020-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k192798-zimmer-segmental-system-fda-510k.jpg K192798 - Zimmer Segmental System K192798 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k200066/ 2020-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k200066-posterior-fusion-plate-ha-posterior-fda-510k.jpg K200066 - Posterior Fusion Plate, HA Posterior Fusion Plate K200066 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinal Simplicity, LLC. Cleared Dec 2020. https://www.510kdatabase.net/k200376/ 2020-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k200376-navbit-sprint-system-supine-fda-510k.jpg K200376 - Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral Registration K200376 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Navbit Pty, Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k201519/ 2020-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k201519-profemur-gladiator-cemented-classic-stem-fda-510k.jpg K201519 - PROFEMUR® GLADIATOR® Cemented Classic Stem K201519 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Microport Orthopedics, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k201745/ 2020-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k201745-deep-learning-image-reconstruction-for-fda-510k.jpg K201745 - Deep Learning Image Reconstruction for Gemstone Spectral Imaging K201745 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems, LLC. Cleared Dec 2020. https://www.510kdatabase.net/k202231/ 2020-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k202231-jade-fda-510k.jpg K202231 - JADE K202231 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: OrbusNeich Medical (Shenzhen) Co., Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k202334/ 2020-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k202334-neuronaute-fda-510k.jpg K202334 - Neuronaute K202334 is a FDA 510(k) cleared neurology medical device. Manufacturer: Bioserenity Sas. Cleared Dec 2020. https://www.510kdatabase.net/k202560/ 2020-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k202560-aquapulse-irrigation-tubing-fda-510k.jpg K202560 - AquaPulse Irrigation Tubing K202560 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ga Health Company Limited. Cleared Dec 2020. https://www.510kdatabase.net/k202635/ 2020-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k202635-my01-continuous-compartmental-pressure-fda-510k.jpg K202635 - MY01 Continuous Compartmental Pressure Monitor K202635 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: MY01, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k202673/ 2020-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k202673-x-cera-pre-shaded-zirconia-blanks-fda-510k.jpg K202673 - X-cera Pre-shaded Zirconia Blanks K202673 is a FDA 510(k) cleared dental medical device. Manufacturer: Dongguan Xiangtong Co., Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k202834/ 2020-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k202834-da-vinci-xi-surgical-system-is4000-da-fda-510k.jpg K202834 - da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) K202834 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k203042/ 2020-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k203042-aquilion-exceed-lb-tsx-202a3-v106-with-fda-510k.jpg K203042 - Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-I K203042 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Dec 2020. https://www.510kdatabase.net/k203285/ 2020-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k203285-3m-comply-hydrogen-peroxide-indicator-fda-510k.jpg K203285 - 3M Comply Hydrogen Peroxide Indicator Tape 1228 K203285 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Dec 2020. https://www.510kdatabase.net/k203333/ 2020-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k203333-triever20-curve-catheter-fda-510k.jpg K203333 - Triever20 Curve Catheter K203333 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inari Medical, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k200781/ 2020-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k200781-infrared-body-thermometer-fda-510k.jpg K200781 - Infrared Body Thermometer K200781 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Heitaida Technology Co., Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k201469/ 2020-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k201469-mini-spike-plus-68r-fda-510k.jpg K201469 - Mini Spike Plus 6/8R K201469 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k201893/ 2020-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k201893-disposable-surgical-mask-fda-510k.jpg K201893 - Disposable Surgical Mask K201893 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Xiamen Probtain Medical Techology Co., Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k202247/ 2020-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k202247-v30-system-v20-system-v10-system-v-vr-fda-510k.jpg K202247 - V30 system, V20 system, V10 system, V-VR Hand piece K202247 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Viora , Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k203119/ 2020-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k203119-clearpetra-suction-evacuation-sheath-fda-510k.jpg K203119 - ClearPetra Suction-Evacuation Sheath K203119 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Well Lead Medical Co., Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k203321/ 2020-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k203321-cystoject-syringe-lever-fda-510k.jpg K203321 - Cystoject Syringe Lever K203321 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Urogen Pharma, Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k200196/ 2020-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k200196-taperloc-complete-hip-stems-fda-510k.jpg K200196 - Taperloc® Complete Hip Stems K200196 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet Orthopedics. Cleared Dec 2020. https://www.510kdatabase.net/k200951/ 2020-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k200951-accu-joint-hemi-implant-fda-510k.jpg K200951 - Accu-Joint Hemi Implant K200951 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Accufix Surgical, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k201253/ 2020-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k201253-modular-rail-system-taylor-spatial-fda-510k.jpg K201253 - Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, Other External Fixation K201253 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew. Cleared Dec 2020. https://www.510kdatabase.net/k201711/ 2020-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k201711-cares-screw-retained-bars-and-bridges-fda-510k.jpg K201711 - CARES Screw - Retained Bars and Bridges (SRBB) K201711 is a FDA 510(k) cleared dental medical device. Manufacturer: Medentika GmbH. Cleared Dec 2020. https://www.510kdatabase.net/k201865/ 2020-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k201865-biomonitor-iii-biomonitor-iiim-fda-510k.jpg K201865 - Biomonitor III, Biomonitor IIIm K201865 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biotronik, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k202189/ 2020-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k202189-graffiti-fda-510k.jpg K202189 - Graffiti K202189 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k202623/ 2020-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k202623-novapak-nasal-sinus-packing-and-stent-fda-510k.jpg K202623 - Novapak Nasal Sinus Packing and Stent K202623 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Medtronic Xomed. Cleared Dec 2020. https://www.510kdatabase.net/k202631/ 2020-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k202631-ihelmet-laser-comb-fda-510k.jpg K202631 - iHelmet Laser Comb K202631 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Slinph Technologies Co., Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k202648/ 2020-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k202648-biofeedback-nerve-and-muscle-stimulator-fda-510k.jpg K202648 - Biofeedback Nerve and Muscle Stimulator K202648 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Shenzhen Konmed Technology Co., Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k202661/ 2020-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k202661-evis-exera-iii-duodenovideoscope-fda-510k.jpg K202661 - Evis Exera III Duodenovideoscope Olympus TJF-Q190V K202661 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Dec 2020. https://www.510kdatabase.net/k202983/ 2020-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k202983-easy-hairfull-fda-510k.jpg K202983 - easy Hairfull K202983 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Y & J Bio Co., Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k203291/ 2020-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k203291-cd-horizon-spinal-system-instruments-fda-510k.jpg K203291 - CD Horizon Spinal System Instruments K203291 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k200618/ 2020-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k200618-hydrosens-a-hioxifilcon-a-spherical-fda-510k.jpg K200618 - HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens K200618 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Visco Vision, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k200884/ 2020-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k200884-b-secur-heartkey-software-library-fda-510k.jpg K200884 - B-Secur HeartKey Software Library K200884 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: B-Secur , Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k201003/ 2020-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k201003-callaly-tampliner-fda-510k.jpg K201003 - Callaly Tampliner K201003 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Calla Lily Personal Care, Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k201039/ 2020-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k201039-hepafat-ai-fda-510k.jpg K201039 - HepaFat-AI K201039 is a FDA 510(k) cleared radiology medical device. Manufacturer: Resonance Health Analysis Services Pty, Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k201183/ 2020-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k201183-vortex-radial-spray-catheter-fda-510k.jpg K201183 - Vortex Radial Spray Catheter K201183 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: CSA Medical, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k201384/ 2020-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k201384-pulse-oximeter-fda-510k.jpg K201384 - Pulse Oximeter K201384 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Raysintone Technology Co., Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k201864/ 2020-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k201864-yuwell-infrared-thermometer-fda-510k.jpg K201864 - YUWELL Infrared Thermometer K201864 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Yuyue Medical Equipment& Supply Co., Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k202173/ 2020-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k202173-pulse-oximeter-fda-510k.jpg K202173 - Pulse Oximeter K202173 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen AOJ Medical Technology Co., Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k202330/ 2020-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k202330-impella-xr-sheath-set-fda-510k.jpg K202330 - Impella XR Sheath Set K202330 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abiomed, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k202588/ 2020-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k202588-bna-platform-fda-510k.jpg K202588 - BNA Platform K202588 is a FDA 510(k) cleared neurology medical device. Manufacturer: Elminda, Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k202701/ 2020-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k202701-gia-stapler-with-tri-staple-technology-fda-510k.jpg K202701 - GIA Stapler with Tri-Staple Technology K202701 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien. Cleared Dec 2020. https://www.510kdatabase.net/k203130/ 2020-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k203130-ophthalmic-yag-laser-system-yc-200-fda-510k.jpg K203130 - Ophthalmic Yag Laser System YC-200 K203130 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Nidek Co., Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k203284/ 2020-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k203284-3m-attest-vaporized-hydrogen-peroxide-fda-510k.jpg K203284 - 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator K203284 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Dec 2020. https://www.510kdatabase.net/k202599/ 2020-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k202599-transtek-wrist-blood-pressure-monitor-fda-510k.jpg K202599 - Transtek Wrist Blood Pressure Monitor K202599 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Guangdong Transtek Medical Electronics Co., Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k203016/ 2020-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k203016-dvt-2600-fda-510k.jpg K203016 - DVT-2600 K203016 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Daesung Maref Co., Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k193444/ 2020-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k193444-vagisan-moistcream-cremolum-fda-510k.jpg K193444 - Vagisan MoistCream Cremolum K193444 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Dr. August Wolff GmbH & Co. KG Arzneimittel. Cleared Dec 2020. https://www.510kdatabase.net/k193508/ 2020-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k193508-thermo-scientific-oxoid-eravacycline-fda-510k.jpg K193508 - Thermo Scientific Oxoid Eravacycline Disc (20ug) ERV20 K193508 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Oxoid Limited (Part of Thermo Fisher Scientific). Cleared Dec 2020. https://www.510kdatabase.net/k193646/ 2020-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k193646-dynamic-gas-scavenging-system-2-dgss-2-fda-510k.jpg K193646 - Dynamic Gas Scavenging System 2 (DGSS - 2) K193646 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Anesthetic Gas Reclamation, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k200442/ 2020-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k200442-inbody-fda-510k.jpg K200442 - InBody K200442 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inbody Co., Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k200646/ 2020-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k200646-tubeclear-system-fda-510k.jpg K200646 - TubeClear System K200646 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Actuated Medical, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k200716/ 2020-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k200716-electronic-blood-pressure-monitor-fda-510k.jpg K200716 - Electronic Blood Pressure Monitor K200716 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Pango Electronic Co., Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k200789/ 2020-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k200789-lnk-mis-spinal-system-pathloc-l-mis-fda-510k.jpg K200789 - LnK MIS Spinal System, PathLoc-L MIS Spinal System, AccelFix-MIS Spinal System K200789 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: L & K Biomed Co., Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k200876/ 2020-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k200876-dexcom-g6-continuous-glucose-fda-510k.jpg K200876 - Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System K200876 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dexcom, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k201317/ 2020-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k201317-ttbio-evoclean-ultrasonic-scaler-fda-510k.jpg K201317 - TTBIO EVOCLEAN Ultrasonic Scaler K201317 is a FDA 510(k) cleared dental medical device. Manufacturer: Ttbio Corp.. Cleared Dec 2020. https://www.510kdatabase.net/k201541/ 2020-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k201541-flowtriever-retrievalaspiration-system-fda-510k.jpg K201541 - FlowTriever Retrieval/Aspiration System K201541 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inari Medical. Cleared Dec 2020. https://www.510kdatabase.net/k202264/ 2020-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k202264-neocis-guidance-system-ngs-with-yomi-fda-510k.jpg K202264 - Neocis Guidance System (NGS) with Yomi Plan v2.0 K202264 is a FDA 510(k) cleared dental medical device. Manufacturer: Neocis, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k202487/ 2020-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k202487-healthjoint-fda-510k.jpg K202487 - HealthJOINT K202487 is a FDA 510(k) cleared radiology medical device. Manufacturer: Zebra Medical Vision, Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k202837/ 2020-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k202837-gospiro-fda-510k.jpg K202837 - GoSpiro K202837 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Monitored Therapeutics, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k203249/ 2020-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k203249-nucleusio-fda-510k.jpg K203249 - Nucleus.io K203249 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nucleushealth, LLC. Cleared Dec 2020. https://www.510kdatabase.net/k193008/ 2020-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k193008-tricoglam-home-use-fda-510k.jpg K193008 - Tricoglam Home Use K193008 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Advihair S.R.L.. Cleared Dec 2020. https://www.510kdatabase.net/k200404/ 2020-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k200404-orise-proknife-fda-510k.jpg K200404 - ORISE ProKnife K200404 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Dec 2020. https://www.510kdatabase.net/k201167/ 2020-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k201167-airehealth-nebulizertm-fda-510k.jpg K201167 - AireHealth NebulizerTM K201167 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Airehealth, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k201729/ 2020-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k201729-medical-mask-fda-510k.jpg K201729 - Medical Mask K201729 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zhende Medical Co., Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k201940/ 2020-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k201940-braces-on-demand-bracket-fda-510k.jpg K201940 - Braces on Demand Bracket K201940 is a FDA 510(k) cleared dental medical device. Manufacturer: Braces on Demand, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k201977/ 2020-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k201977-temptraq-fda-510k.jpg K201977 - TempTraq K201977 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Blue Spark Technologies, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k202034/ 2020-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k202034-aprevo-intervertebral-body-fusion-device-fda-510k.jpg K202034 - aprevo Intervertebral Body Fusion Device K202034 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Carlsmed, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k202418/ 2020-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k202418-magic-ucla-abutment-system-fda-510k.jpg K202418 - Magic UCLA Abutment System K202418 is a FDA 510(k) cleared dental medical device. Manufacturer: Innobiosurg Co., Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k202452/ 2020-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k202452-nobelprocera-zirconia-implant-bridge-fda-510k.jpg K202452 - NobelProcera Zirconia Implant Bridge K202452 is a FDA 510(k) cleared dental medical device. Manufacturer: Nobel Biocare AB. Cleared Dec 2020. https://www.510kdatabase.net/k203087/ 2020-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k203087-combidiagnost-r90-fda-510k.jpg K203087 - CombiDiagnost R90 K203087 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Dmc GmbH. Cleared Dec 2020. https://www.510kdatabase.net/k203253/ 2020-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k203253-nuvasive-acp-system-fda-510k.jpg K203253 - NuVasive ACP System K203253 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Dec 2020. https://www.510kdatabase.net/k203367/ 2020-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k203367-linesider-spinal-system-fda-510k.jpg K203367 - LineSider™ Spinal System K203367 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Integrity Implants, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k200572/ 2020-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k200572-planmeca-romexis-fda-510k.jpg K200572 - Planmeca Romexis K200572 is a FDA 510(k) cleared radiology medical device. Manufacturer: Planmeca Oy. Cleared Dec 2020. https://www.510kdatabase.net/k200719/ 2020-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k200719-nuvasive-navigations-instruments-fda-510k.jpg K200719 - NuVasive Navigation.S Instruments K200719 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Dec 2020. https://www.510kdatabase.net/k201072/ 2020-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k201072-ensemble-cmc-size-141-ensemble-cmc-fda-510k.jpg K201072 - Ensemble CMC, Size 141, Ensemble CMC, Size 151, Ensemble CMC, Size 161 K201072 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ensemble Orthopedics, LLC. Cleared Dec 2020. https://www.510kdatabase.net/k202270/ 2020-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k202270-ez-trax-stryker-mako-total-knee-with-fda-510k.jpg K202270 - EZ-TRAX Stryker Mako Total Knee with Triathlon Containment Device K202270 is a FDA 510(k) cleared general hospital medical device. Manufacturer: K1 Medical, LLC. Cleared Dec 2020. https://www.510kdatabase.net/k202384/ 2020-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k202384-palm-care-blue-nitrile-examination-fda-510k.jpg K202384 - Palm Care Blue Nitrile Examination Gloves Powder Free K202384 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hi-Care Thai Gloves Co. , Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k202565/ 2020-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k202565-wavicide-opa-mec-indicator-fda-510k.jpg K202565 - WAVICIDE-OPA MEC Indicator K202565 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Serim Research Corporation. Cleared Dec 2020. https://www.510kdatabase.net/k202835/ 2020-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k202835-auryon-atherectomy-system-fda-510k.jpg K202835 - Auryon Atherectomy System K202835 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Eximo Medical, Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k203041/ 2020-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k203041-sms-cementless-stem-fda-510k.jpg K203041 - SMS Cementless Stem K203041 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Dec 2020. https://www.510kdatabase.net/k203053/ 2020-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k203053-vantage-orian-15t-mrt-1550-v70-with-fda-510k.jpg K203053 - Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR K203053 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Dec 2020. https://www.510kdatabase.net/k203159/ 2020-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k203159-lux-35-detector-fda-510k.jpg K203159 - Lux 35 Detector K203159 is a FDA 510(k) cleared radiology medical device. Manufacturer: Carestream Health. Cleared Dec 2020. https://www.510kdatabase.net/k192970/ 2020-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k192970-slimus-fda-510k.jpg K192970 - SLIMUS K192970 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Hironic Co., Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k201015/ 2020-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k201015-acqmap-high-resolution-imaging-and-fda-510k.jpg K201015 - AcQMap High Resolution Imaging and Mapping System K201015 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Acutus Medical, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k201712/ 2020-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k201712-z5-tl-fda-510k.jpg K201712 - Z5-TL K201712 is a FDA 510(k) cleared dental medical device. Manufacturer: Z-Systems AG. Cleared Dec 2020. https://www.510kdatabase.net/k202069/ 2020-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k202069-base4-disposable-medical-mask-fda-510k.jpg K202069 - BASE4 Disposable Medical Mask K202069 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Base4 Group, Inc.. Cleared Dec 2020. https://www.510kdatabase.net/k202377/ 2020-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k202377-palm-care-latex-examination-powder-fda-510k.jpg K202377 - Palm Care Latex Examination Powder Free Gloves K202377 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hi-Care Thai Gloves Co. , Ltd.. Cleared Dec 2020. https://www.510kdatabase.net/k202388/ 2020-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k202388-apolo-d-apolo-s-fda-510k.jpg K202388 - Apolo D / Apolo S K202388 is a FDA 510(k) cleared radiology medical device. Manufacturer: Vmi Tecnologias Ltda. Cleared Dec 2020. https://www.510kdatabase.net/k202659/ 2020-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k202659-stryker-arthroscope-fda-510k.jpg K202659 - Stryker Arthroscope K202659 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker. Cleared Dec 2020. https://www.510kdatabase.net/k202876/ 2020-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k202876-confirm-rx-insertable-cardiac-monitor-fda-510k.jpg K202876 - Confirm Rx Insertable Cardiac Monitor K202876 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott (St. Jude Medical). Cleared Dec 2020. https://www.510kdatabase.net/k203199/ 2020-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k203199-ras-12-rack-ras-12-long-rack-used-in-fda-510k.jpg K203199 - RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-Disinfector K203199 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Dec 2020. https://www.510kdatabase.net/k200155/ 2020-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k200155-bright-high-flow-fda-510k.jpg K200155 - Bright High Flow K200155 is a FDA 510(k) cleared dental medical device. Manufacturer: Genoss Co., Ltd.. Cleared Nov 2020. https://www.510kdatabase.net/k200372/ 2020-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k200372-smoke-evacuation-fingerswitch-smoke-fda-510k.jpg K200372 - Smoke Evacuation Fingerswitch, Smoke evacuation system with electrosurgical pencil K200372 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Modern Medical Equipment Manufacturing, Ltd.. Cleared Nov 2020. https://www.510kdatabase.net/k201687/ 2020-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k201687-avenda-health-treatment-system-fda-510k.jpg K201687 - Avenda Health Treatment System K201687 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Avenda Health, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k202416/ 2020-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k202416-kimtech-prizm-multi-layered-exam-glove-fda-510k.jpg K202416 - Kimtech Prizm Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid, Kimtech Prizm Xtra Multi-Layered Exam Glove Tested for use with Chemotherapy Drugs, the Opioid Fentanyl Citrate, simulated Gastric Acid, and Fentanyl in Gastric Acid K202416 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Kimberly Clark Corporation. Cleared Nov 2020. https://www.510kdatabase.net/k201173/ 2020-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k201173-e-guard-fda-510k.jpg K201173 - E-Guard K201173 is a FDA 510(k) cleared dental medical device. Manufacturer: Envisiontec GmbH. Cleared Nov 2020. https://www.510kdatabase.net/k201294/ 2020-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k201294-pulse-oximeter-fda-510k.jpg K201294 - Pulse Oximeter K201294 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Guangdong Long Yao Electronic Technology Co., Ltd.. Cleared Nov 2020. https://www.510kdatabase.net/k201308/ 2020-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k201308-axonpen-axonmonitor-axonbox-tablet-fda-510k.jpg K201308 - Axonpen, Axonmonitor, Axonbox, Tablet K201308 is a FDA 510(k) cleared neurology medical device. Manufacturer: Clearmind Biomedical. Cleared Nov 2020. https://www.510kdatabase.net/k201653/ 2020-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k201653-compex-sport-elite-30-fda-510k.jpg K201653 - Compex Sport Elite 3.0 K201653 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Djo, LLC. Cleared Nov 2020. https://www.510kdatabase.net/k202851/ 2020-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k202851-spo2-sensor-fda-510k.jpg K202851 - Spo2 Sensor K202851 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Jkh USA, LLC. Cleared Nov 2020. https://www.510kdatabase.net/k203268/ 2020-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k203268-arthrex-fibertak-suture-anchor-fda-510k.jpg K203268 - Arthrex FiberTak Suture Anchor K203268 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k192177/ 2020-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k192177-sysmed-st-fda-510k.jpg K192177 - SysMed S/T K192177 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sysmed (China) Co., Ltd.. Cleared Nov 2020. https://www.510kdatabase.net/k192285/ 2020-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k192285-cpr-face-shield-fda-510k.jpg K192285 - CPR Face Shield K192285 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Firstar Healthcare Company Limited (Guangzhou). Cleared Nov 2020. https://www.510kdatabase.net/k192406/ 2020-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k192406-avecure-bt-microwave-ablation-system-fda-510k.jpg K192406 - AveCure BT Microwave Ablation System K192406 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medwaves, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k193155/ 2020-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k193155-nipro-dry-complete-dry-acid-fda-510k.jpg K193155 - Nipro Dry Complete Dry Acid Concentrate for Hemodialysis K193155 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Nipro Renal Solutions USA, Corp.. Cleared Nov 2020. https://www.510kdatabase.net/k193377/ 2020-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k193377-toplock-anchor-system-fda-510k.jpg K193377 - TopLock Anchor System K193377 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Fusion Orthopedics, LLC. Cleared Nov 2020. https://www.510kdatabase.net/k200402/ 2020-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k200402-dr-hos-electro-therapy-conductive-gel-fda-510k.jpg K200402 - DR-HO'S Electro Therapy Conductive Gel K200402 is a FDA 510(k) cleared neurology medical device. Manufacturer: Guangzhou Xinbo Electronic Co., Ltd.. Cleared Nov 2020. https://www.510kdatabase.net/k200484/ 2020-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k200484-carto-3-ep-navigation-system-with-fda-510k.jpg K200484 - CARTO® 3 EP Navigation System with Signal Processing Unit K200484 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biosense Webster, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k200761/ 2020-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k200761-tenax-laser-resistant-endotracheal-tube-fda-510k.jpg K200761 - Tenax Laser Resistant Endotracheal Tube K200761 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Bryan Medical, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k201193/ 2020-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k201193-seaspine-spacer-system-nm-hollywood-fda-510k.jpg K201193 - SeaSpine Spacer System NM (Hollywood, Hollywood VI, Pacifica, Redondo, Ventura), Vu a•POD-L NanoMetalene K201193 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared Nov 2020. https://www.510kdatabase.net/k202066/ 2020-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k202066-ensite-x-ep-system-advisor-vl-circular-fda-510k.jpg K202066 - EnSite X EP System, Advisor VL Circular Mapping Catheter, Sensor Enabled, Advisor FL Circular Mapping Catheter, Sensor Enabled, Advisor HD Grid High Density Mapping Catheter, Senor Enabled K202066 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared Nov 2020. https://www.510kdatabase.net/k202079/ 2020-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k202079-physiq-fda-510k.jpg K202079 - Physiq K202079 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: El.En Electronic Engineering Spa. Cleared Nov 2020. https://www.510kdatabase.net/k202098/ 2020-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k202098-global-unite-platform-shoulder-system-fda-510k.jpg K202098 - GLOBAL UNITE™ Platform Shoulder System K202098 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Ireland UC. Cleared Nov 2020. https://www.510kdatabase.net/k202194/ 2020-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k202194-attune-porous-fixed-bearing-tibial-fda-510k.jpg K202194 - ATTUNE® Porous Fixed Bearing Tibial Base, Medialized Dome Patella, and Medialized Anatomic Patella with AFFIXIUM™ 3DP Technology K202194 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Ireland UC. Cleared Nov 2020. https://www.510kdatabase.net/k202250/ 2020-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k202250-dermatological-carbon-dioxide-laser-fda-510k.jpg K202250 - Dermatological Carbon Dioxide Laser Systems K202250 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Zhuolu Jontelaser Manufacturing Technology Co., Ltd.. Cleared Nov 2020. https://www.510kdatabase.net/k202269/ 2020-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k202269-pre-milled-abutment-fda-510k.jpg K202269 - PRE-MILLED Abutment K202269 is a FDA 510(k) cleared dental medical device. Manufacturer: Mit Global Co., Ltd.. Cleared Nov 2020. https://www.510kdatabase.net/k202306/ 2020-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k202306-t3-platform-software-fda-510k.jpg K202306 - T3 Platform software K202306 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Etiometry, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k202465/ 2020-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k202465-night-guard-fda-510k.jpg K202465 - Night Guard K202465 is a FDA 510(k) cleared dental medical device. Manufacturer: 3D Diagnostix, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k202470/ 2020-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k202470-li-battery-powered-otc-tensems-model-fda-510k.jpg K202470 - Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300 K202470 is a FDA 510(k) cleared neurology medical device. Manufacturer: Everyway Medical Instruments Co.,Ltd. Cleared Nov 2020. https://www.510kdatabase.net/k202883/ 2020-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k202883-sterile-bone-screw-peek-acl-screw-fda-510k.jpg K202883 - Sterile bone screw (PEEK ACL screw) K202883 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonic Co., Ltd.. Cleared Nov 2020. https://www.510kdatabase.net/k203216/ 2020-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k203216-the-multimodality-advanced-vessel-fda-510k.jpg K203216 - The Multimodality Advanced Vessel Analysis K203216 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Nov 2020. https://www.510kdatabase.net/k203317/ 2020-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k203317-carboclear-x-pedicle-screw-system-fda-510k.jpg K203317 - CarboClear X Pedicle Screw System K203317 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: CarboFix Orthopedics , Ltd.. Cleared Nov 2020. https://www.510kdatabase.net/den200029/ 2020-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/den200029-parallel-fda-510k.jpg DEN200029 - Parallel DEN200029 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Mahana Therapeutics, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k193158/ 2020-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k193158-acent-central-venous-catheter-fda-510k.jpg K193158 - ACENT™ Central Venous Catheter K193158 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Global Medikit Limited. Cleared Nov 2020. https://www.510kdatabase.net/k200798/ 2020-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k200798-g-cem-one-fda-510k.jpg K200798 - G-CEM ONE K200798 is a FDA 510(k) cleared dental medical device. Manufacturer: GC America, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k200931/ 2020-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k200931-rf-surgical-generator-fda-510k.jpg K200931 - RF Surgical Generator K200931 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Fulwell, LLC. Cleared Nov 2020. https://www.510kdatabase.net/k201622/ 2020-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k201622-medical-surgical-mask-fda-510k.jpg K201622 - Medical surgical mask K201622 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guangdong Kingfa Sci. & Tech.Co., Ltd.. Cleared Nov 2020. https://www.510kdatabase.net/k201742/ 2020-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k201742-ekuore-one-wireless-electronic-fda-510k.jpg K201742 - eKuore One Wireless Electronic Interface for stethoscope K201742 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Chip Ideas Electronics S.L.. Cleared Nov 2020. https://www.510kdatabase.net/k201904/ 2020-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k201904-monet-curing-laser-fda-510k.jpg K201904 - Monet Curing Laser K201904 is a FDA 510(k) cleared dental medical device. Manufacturer: CAO Group, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k202515/ 2020-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k202515-nuvo-implant-system-nuvo-instrument-fda-510k.jpg K202515 - NUVO Implant System – NUVO Instrument Kit Cases K202515 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jjgc Industria E Comercio DE Materiais Dentarios S.A.. Cleared Nov 2020. https://www.510kdatabase.net/k202682/ 2020-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k202682-promisemed-triple-safety-pen-needle-fda-510k.jpg K202682 - Promisemed Triple Safety Pen Needle K202682 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Promisemed Hangzhou Meditech Co., Ltd.. Cleared Nov 2020. https://www.510kdatabase.net/k202943/ 2020-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k202943-optomonitor-3-fda-510k.jpg K202943 - OptoMonitor 3 K202943 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Opsens, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k202959/ 2020-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k202959-polylock-plating-system-fda-510k.jpg K202959 - PolyLock Plating System K202959 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Fusion Orthopedics, LLC. Cleared Nov 2020. https://www.510kdatabase.net/k202972/ 2020-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k202972-anterior-cervical-plate-system-fda-510k.jpg K202972 - Anterior Cervical Plate System K202972 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nutech Spine and Biologics. Cleared Nov 2020. https://www.510kdatabase.net/k203024/ 2020-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k203024-c2-cryoballoon-catheter-pear-c2-fda-510k.jpg K203024 - C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge K203024 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Pentax of America, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k203081/ 2020-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k203081-ram-cor-suture-qucik-load-surgical-fda-510k.jpg K203081 - RAM COR-SUTURE QUCIK LOAD Surgical Suture, COR-SUTURE QUICK LOAD Surgical Suture K203081 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lsi Solutions. Cleared Nov 2020. https://www.510kdatabase.net/k203120/ 2020-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k203120-rd-quick-load-suture-0-polyester-rd-fda-510k.jpg K203120 - RD QUICK LOAD SUTURE, 0 Polyester, RD QUICK LOAD SUTURE, 2-0 Polyester, RD QUCIK LOAD SUTURE, 2-0 Polypropylene K203120 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lsi Solutions, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/den190047/ 2020-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/den190047-cadscor-system-fda-510k.jpg DEN190047 - CADScor System DEN190047 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Acarix A/S. Cleared Nov 2020. https://www.510kdatabase.net/k193621/ 2020-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k193621-digital-thermometer-model-bt-301-bt-fda-510k.jpg K193621 - Digital Thermometer-(Model BT-301, BT-302, BT-303, BT-305, BT-306, BT-308, BT-311, BT-318) K193621 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Dongguan E-Test Technology Co., Ltd.. Cleared Nov 2020. https://www.510kdatabase.net/k200166/ 2020-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k200166-mirus-ligating-clip-mirus-ligating-fda-510k.jpg K200166 - Mirus Ligating Clip, Mirus Ligating Clip Applier K200166 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: M/s. Meril Endo Surgery Private Limited.. Cleared Nov 2020. https://www.510kdatabase.net/k201484/ 2020-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k201484-somnos-anti-snoring-mouth-guard-fda-510k.jpg K201484 - Somnos Anti-Snoring Mouth Guard K201484 is a FDA 510(k) cleared dental medical device. Manufacturer: Koncept Innovators, LLC. Cleared Nov 2020. https://www.510kdatabase.net/k201991/ 2020-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k201991-medical-surgical-mask-fda-510k.jpg K201991 - Medical surgical mask K201991 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen Everwin Precision Technology Co., Ltd.. Cleared Nov 2020. https://www.510kdatabase.net/k202475/ 2020-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k202475-palacos-r-palacos-r-pro-palacos-rg-fda-510k.jpg K202475 - PALACOS R, PALACOS R pro, PALACOS R+G, PALACOS R+G pro, PALACOS MV+G K202475 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Heraeus Medical GmbH. Cleared Nov 2020. https://www.510kdatabase.net/k202888/ 2020-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k202888-confirm-rx-insertable-cardiac-monitor-fda-510k.jpg K202888 - Confirm Rx Insertable Cardiac Monitor K202888 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott (St. Jude Medical). Cleared Nov 2020. https://www.510kdatabase.net/k203056/ 2020-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k203056-invictus-spinal-fixation-system-fda-510k.jpg K203056 - Invictus™ Spinal Fixation System K203056 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k202090/ 2020-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k202090-biogel-eclipse-biogel-eclipse-fda-510k.jpg K202090 - Biogel Eclipse / Biogel Eclipse Indicator Underglove, Biogel Surgeons / Biogel Indicator Underglove, Biogel PI Micro Indicator Underglove, Biogel PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim K202090 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Molnlycke Health Care Us, LLC. Cleared Nov 2020. https://www.510kdatabase.net/k193056/ 2020-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k193056-puritan-bennett-980-series-ventilator-fda-510k.jpg K193056 - Puritan Bennett 980 Series Ventilator System K193056 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Covidien, LLC. Cleared Nov 2020. https://www.510kdatabase.net/k193191/ 2020-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k193191-medumat-easy-cpr-medumat-easy-cpr-with-fda-510k.jpg K193191 - MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag K193191 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Weinmann Emergency Medical Technology GmbH + Co. KG. Cleared Nov 2020. https://www.510kdatabase.net/k193285/ 2020-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k193285-v-onestep-fda-510k.jpg K193285 - V-ONESTEP K193285 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Vitromed GmbH. Cleared Nov 2020. https://www.510kdatabase.net/k193287/ 2020-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k193287-corinsights-mri-fda-510k.jpg K193287 - CorInsights MRI K193287 is a FDA 510(k) cleared radiology medical device. Manufacturer: Adm Diagnostics, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k193346/ 2020-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k193346-codman-surgical-patties-strips-fda-510k.jpg K193346 - Codman Surgical Patties & Strips K193346 is a FDA 510(k) cleared neurology medical device. Manufacturer: Integra LifeSciences Corporation. Cleared Nov 2020. https://www.510kdatabase.net/k193576/ 2020-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k193576-solitaire-platinum-revascularization-fda-510k.jpg K193576 - Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device) K193576 is a FDA 510(k) cleared neurology medical device. Manufacturer: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. Cleared Nov 2020. https://www.510kdatabase.net/k200873/ 2020-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k200873-halo-fda-510k.jpg K200873 - HALO K200873 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nico-Lab B.V.. Cleared Nov 2020. https://www.510kdatabase.net/k201158/ 2020-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k201158-neurostar-advanced-therapy-fda-510k.jpg K201158 - NeuroStar Advanced Therapy K201158 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neuronetics, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k201325/ 2020-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k201325-optomed-smartscope-m5-with-optomed-fda-510k.jpg K201325 - Optomed Smartscope M5 with Optomed Smartscope FA K201325 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Optomed Oyj. Cleared Nov 2020. https://www.510kdatabase.net/k201404/ 2020-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k201404-passio-pump-drainage-system-fda-510k.jpg K201404 - Passio Pump Drainage System K201404 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Bearpac Medical. Cleared Nov 2020. https://www.510kdatabase.net/k201526/ 2020-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k201526-tipcam1-rubina-video-endoscope-system-fda-510k.jpg K201526 - TIPCAM1 Rubina Video Endoscope System K201526 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Karl Storz Endoscopy America. Cleared Nov 2020. https://www.510kdatabase.net/k201815/ 2020-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k201815-dornier-magellan-ureteral-access-sheath-fda-510k.jpg K201815 - Dornier MAGELLAN Ureteral Access Sheath K201815 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Dornier Medtech America, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k201825/ 2020-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k201825-minicat-2d-fda-510k.jpg K201825 - MiniCAT 2D K201825 is a FDA 510(k) cleared radiology medical device. Manufacturer: Xoran Technologies, LLC. Cleared Nov 2020. https://www.510kdatabase.net/k201984/ 2020-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k201984-mps-3-nd-myocardial-protection-system-fda-510k.jpg K201984 - MPS 3 ND Myocardial Protection System K201984 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quest Medical, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k202000/ 2020-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k202000-silatrix-oral-gel-fda-510k.jpg K202000 - Silatrix Oral Gel K202000 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sa3, LLC. Cleared Nov 2020. https://www.510kdatabase.net/k202035/ 2020-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k202035-vscan-air-fda-510k.jpg K202035 - Vscan Air K202035 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared Nov 2020. https://www.510kdatabase.net/k202042/ 2020-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k202042-reprocessed-viewflex-xtra-ice-fda-510k.jpg K202042 - Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter K202042 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Innovative Health, LLC. Cleared Nov 2020. https://www.510kdatabase.net/k202139/ 2020-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k202139-medical-surgical-mask-fda-510k.jpg K202139 - Medical surgical mask K202139 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guangdong Kingfa Sci. & Tech.Co., Ltd.. Cleared Nov 2020. https://www.510kdatabase.net/k202382/ 2020-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k202382-filmarray-global-fever-panel-external-fda-510k.jpg K202382 - FilmArray Global Fever Panel External Control Kit K202382 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Biofire Defense, LLC. Cleared Nov 2020. https://www.510kdatabase.net/k202413/ 2020-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k202413-lc-resincal-pc-fda-510k.jpg K202413 - LC ResinCal PC K202413 is a FDA 510(k) cleared dental medical device. Manufacturer: S&C Polymer Silicon- Und Composite Spezialitaten GmbH. Cleared Nov 2020. https://www.510kdatabase.net/k202529/ 2020-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k202529-prosomnus-evo-sleep-and-snore-device-fda-510k.jpg K202529 - ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring K202529 is a FDA 510(k) cleared dental medical device. Manufacturer: Prosomnus Sleep Technologies, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k202764/ 2020-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k202764-ortho-solutions-plating-system-fda-510k.jpg K202764 - Ortho Solutions Plating System K202764 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ortho Solutions UK , Ltd.. Cleared Nov 2020. https://www.510kdatabase.net/k202805/ 2020-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k202805-optimized-positioning-system-ops-insight-fda-510k.jpg K202805 - Optimized Positioning System (OPS) Insight K202805 is a FDA 510(k) cleared radiology medical device. Manufacturer: Corin USA. Cleared Nov 2020. https://www.510kdatabase.net/k202962/ 2020-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k202962-smoke-evacuation-button-switch-pencil-fda-510k.jpg K202962 - Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D1, Smoke Evacuation Button Switch Pencil, Non-Ext., 10ft, D2, Smoke Evacuation Button Switch Pencil, Non-Ext., 15ft, D2, Telescopic Smoke Evacuation Button Switch Pencil, 10ft, Telescopic Smoke Evacuation Button Switch Pencil, 15ft, Telescopic Smoke Evacuation Button Switch Pencil, 15ft, Telescopic Smoke Evacuation Button Switch Pencil, Lock, 15ft K202962 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: New Deantronics Taiwan , Ltd.. Cleared Nov 2020. https://www.510kdatabase.net/k203100/ 2020-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k203100-arthrex-eclipse-titanium-humeral-head-fda-510k.jpg K203100 - Arthrex Eclipse Titanium Humeral Head K203100 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k203156/ 2020-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k203156-dtx-studio-clinic-fda-510k.jpg K203156 - DTX Studio Clinic K203156 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nobel Biocare AB. Cleared Nov 2020. https://www.510kdatabase.net/k203169/ 2020-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k203169-revolution-ascend-fda-510k.jpg K203169 - Revolution Ascend K203169 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare Japan Corporation. Cleared Nov 2020. https://www.510kdatabase.net/k203179/ 2020-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k203179-fortress-introducer-sheath-system-fda-510k.jpg K203179 - Fortress Introducer Sheath System K203179 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Contract Medical International, GmbH. Cleared Nov 2020. https://www.510kdatabase.net/den200043/ 2020-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/den200043-filmarray-global-fever-panel-fda-510k.jpg DEN200043 - FilmArray Global Fever Panel DEN200043 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Biofire Defense, LLC. Cleared Nov 2020. https://www.510kdatabase.net/k192503/ 2020-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k192503-gm501-wash-with-phenol-red-and-fda-510k.jpg K192503 - GM501 Wash with Phenol Red and Gentamicin K192503 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Hamilton Thorne Incorporated. Cleared Nov 2020. https://www.510kdatabase.net/k192860/ 2020-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k192860-sapphire-infusion-pump-sapphire-fda-510k.jpg K192860 - Sapphire Infusion Pump, Sapphire administration sets K192860 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Q Core Medical , Ltd.. Cleared Nov 2020. https://www.510kdatabase.net/k200171/ 2020-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k200171-smr-tt-augmented-glenoid-system-fda-510k.jpg K200171 - SMR TT Augmented Glenoid System K200171 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Lima Corporate S.P.A.. Cleared Nov 2020. https://www.510kdatabase.net/k200580/ 2020-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k200580-fotodent-denture-fda-510k.jpg K200580 - FotoDent denture K200580 is a FDA 510(k) cleared dental medical device. Manufacturer: Dreve Dentamid GmbH. Cleared Nov 2020. https://www.510kdatabase.net/k200693/ 2020-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k200693-k2-mobile-fda-510k.jpg K200693 - K2 MOBILE K200693 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Hulaser, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k201694/ 2020-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k201694-air-compression-therapy-device-fda-510k.jpg K201694 - Air Compression Therapy Device K201694 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Shenzhen Dongjilian Electronics Co., Ltd.. Cleared Nov 2020. https://www.510kdatabase.net/k201867/ 2020-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k201867-homechoice-claria-apd-system-fda-510k.jpg K201867 - Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System K201867 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corporation. Cleared Nov 2020. https://www.510kdatabase.net/k202172/ 2020-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k202172-starwalker-fda-510k.jpg K202172 - StarWalker K202172 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Fotona D.O.O.. Cleared Nov 2020. https://www.510kdatabase.net/k202442/ 2020-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k202442-carewear-firefly-wrinkle-reduction-fda-510k.jpg K202442 - Carewear Firefly Wrinkle Reduction K202442 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Carewear Corp.. Cleared Nov 2020. https://www.510kdatabase.net/k202980/ 2020-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k202980-laser-therapy-device-fda-510k.jpg K202980 - Laser Therapy Device K202980 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Leaflife Technology Co., Ltd.. Cleared Nov 2020. https://www.510kdatabase.net/k203008/ 2020-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k203008-diamondback-360-peripheral-orbital-fda-510k.jpg K203008 - DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System K203008 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cardiovascular Systems, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k203167/ 2020-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k203167-depuy-corail-amt-hip-prosthesis-fda-510k.jpg K203167 - DePuy Corail AMT Hip Prosthesis K203167 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k193010/ 2020-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k193010-liebel-flarsheim-ibp-transfer-set-fda-510k.jpg K193010 - Liebel-Flarsheim IBP Transfer Set K193010 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Liebel-Flarsheim Company, LLC. Cleared Nov 2020. https://www.510kdatabase.net/k200472/ 2020-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k200472-viveve-system-fda-510k.jpg K200472 - Viveve System K200472 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Viveve Medical, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k200912/ 2020-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k200912-freedomr-tinbn-coated-knee-fda-510k.jpg K200912 - Freedom(R) - TiNbN Coated Knee K200912 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Maxx Orthopedics, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k201019/ 2020-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k201019-genius-ai-detection-fda-510k.jpg K201019 - Genius AI Detection K201019 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hologic, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k201195/ 2020-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k201195-syngovia-mi-workflows-syngo-mbf-fda-510k.jpg K201195 - syngo.via MI Workflows, syngo MBF K201195 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k201382/ 2020-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k201382-x-mind-prime-3d-under-trademark-acteon-fda-510k.jpg K201382 - X-MIND prime 3D (under trademark Acteon), I-MAX 3D (under trademark Owandy Radiology) K201382 is a FDA 510(k) cleared radiology medical device. Manufacturer: De Gotzen S.R.L.. Cleared Nov 2020. https://www.510kdatabase.net/k202150/ 2020-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k202150-glidepath-75f-long-term-dialysis-fda-510k.jpg K202150 - GlidePath 7.5F Long-Term Dialysis Catheter K202150 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k202233/ 2020-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k202233-venue-go-fda-510k.jpg K202233 - Venue Go K202233 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared Nov 2020. https://www.510kdatabase.net/k202449/ 2020-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k202449-signature-latex-lt-powder-free-fda-510k.jpg K202449 - Signature Latex LT, Powder-Free, Surgical Glove, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim of <50µg/dm² per glove of Extractable Protein K202449 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k202503/ 2020-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k202503-chrome-fda-510k.jpg K202503 - Chrome K202503 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Quanta System Spa. Cleared Nov 2020. https://www.510kdatabase.net/k202535/ 2020-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k202535-arthrex-fastthread-interference-screw-fda-510k.jpg K202535 - Arthrex FastThread Interference Screw K202535 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k202713/ 2020-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k202713-trueview-100-pro-fda-510k.jpg K202713 - TrueView 100 Pro K202713 is a FDA 510(k) cleared radiology medical device. Manufacturer: Compai Healthcare (Shenzhen) Co.,Ltd. Cleared Nov 2020. https://www.510kdatabase.net/k202800/ 2020-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k202800-pacific-plus-pta-catheter-fda-510k.jpg K202800 - Pacific Plus PTA Catheter K202800 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular,Inc(Formerly D.B.A Ev3 Inc.,Covidien, LLC). Cleared Nov 2020. https://www.510kdatabase.net/k202821/ 2020-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k202821-indigo-aspiration-system-aspiration-fda-510k.jpg K202821 - Indigo Aspiration System - Aspiration Catheter 12 and Separator 12 K202821 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Penumbra, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k203138/ 2020-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k203138-firebird-si-fusion-system-fda-510k.jpg K203138 - FIREBIRD SI Fusion System K203138 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthofix, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k203187/ 2020-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k203187-hirise-fda-510k.jpg K203187 - HiRise K203187 is a FDA 510(k) cleared radiology medical device. Manufacturer: Curvebeam, LLC. Cleared Nov 2020. https://www.510kdatabase.net/k203287/ 2020-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k203287-dbswin-vistaeasy-fda-510k.jpg K203287 - DBSWIN, VISTAEASY K203287 is a FDA 510(k) cleared radiology medical device. Manufacturer: D?rr Dental SE. Cleared Nov 2020. https://www.510kdatabase.net/k193306/ 2020-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k193306-proview-fda-510k.jpg K193306 - PROView K193306 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems SCS. Cleared Nov 2020. https://www.510kdatabase.net/k200612/ 2020-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k200612-r501-aortic-root-cannula-without-vent-fda-510k.jpg K200612 - R501 aortic root cannula without vent line, R502 aortic root cannula with vent line K200612 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sorin Group Italia S.R.L.. Cleared Nov 2020. https://www.510kdatabase.net/k200992/ 2020-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k200992-sin-dental-implant-system-fda-510k.jpg K200992 - S.I.N. Dental Implant System K200992 is a FDA 510(k) cleared dental medical device. Manufacturer: S.I.N. ? Sistema DE Implante Nacional S.A.. Cleared Nov 2020. https://www.510kdatabase.net/k201998/ 2020-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k201998-jeti-aio-peripheral-thrombectomy-system-fda-510k.jpg K201998 - JETi AIO Peripheral Thrombectomy System K201998 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Walk Vascular, LLC. Cleared Nov 2020. https://www.510kdatabase.net/k202307/ 2020-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k202307-activ-fuse-fda-510k.jpg K202307 - Activ Fuse K202307 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Newclip Technics. Cleared Nov 2020. https://www.510kdatabase.net/k202444/ 2020-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k202444-knotless-tensiontight-button-implant-fda-510k.jpg K202444 - Knotless TensionTight Button Implant System K202444 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k202777/ 2020-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k202777-verifixx-small-bone-implant-fda-510k.jpg K202777 - VeriFixx™ Small Bone Implant K202777 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Armis Biopharma, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k202931/ 2020-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k202931-disposable-trocar-fda-510k.jpg K202931 - Disposable Trocar K202931 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wuxi Shukang Medical Appliance Co., Ltd.. Cleared Nov 2020. https://www.510kdatabase.net/k193193/ 2020-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k193193-telio-cad-abutment-solutions-extra-fda-510k.jpg K193193 - Telio CAD Abutment Solutions- extra systems K193193 is a FDA 510(k) cleared dental medical device. Manufacturer: Ivoclar Vivadent, AG. Cleared Nov 2020. https://www.510kdatabase.net/k200461/ 2020-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k200461-freeprint-denture-fda-510k.jpg K200461 - Freeprint denture K200461 is a FDA 510(k) cleared dental medical device. Manufacturer: Detax GmbH & Co. KG. Cleared Nov 2020. https://www.510kdatabase.net/k200706/ 2020-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k200706-sientra-opus-silicone-gel-breast-fda-510k.jpg K200706 - Sientra OPUS Silicone Gel Breast Implant Sizer K200706 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sientra, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k201060/ 2020-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k201060-cordiana-dx16-fda-510k.jpg K201060 - Cordiana Dx16 K201060 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordiana Medical Informatics AG. Cleared Nov 2020. https://www.510kdatabase.net/k201918/ 2020-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k201918-evos-large-fragment-plating-system-fda-510k.jpg K201918 - EVOS Large Fragment Plating System K201918 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k202343/ 2020-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k202343-microscan-dried-gram-negative-miccombo-fda-510k.jpg K202343 - MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL ) K202343 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k202344/ 2020-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k202344-tiultra-implants-and-xeal-abutments-fda-510k.jpg K202344 - TiUltra Implants and Xeal Abutments K202344 is a FDA 510(k) cleared dental medical device. Manufacturer: Nobel Biocare AB. Cleared Nov 2020. https://www.510kdatabase.net/k202370/ 2020-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k202370-ion-endoluminal-system-fda-510k.jpg K202370 - Ion Endoluminal System K202370 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k202490/ 2020-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k202490-avid-ct2-fda-510k.jpg K202490 - Avid CT2 K202490 is a FDA 510(k) cleared neurology medical device. Manufacturer: Vision Quest Industries Inc./Dba VQ Orthocare. Cleared Nov 2020. https://www.510kdatabase.net/k202758/ 2020-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k202758-nd-yag-laser-therapy-systems-hm-yl900-fda-510k.jpg K202758 - Nd: YAG Laser Therapy Systems HM-YL900 K202758 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shangdong Huamei Technology Co., Ltd.. Cleared Nov 2020. https://www.510kdatabase.net/k202762/ 2020-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k202762-circular-fixation-with-balanced-cable-fda-510k.jpg K202762 - Circular Fixation with Balanced Cable Transport K202762 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k203149/ 2020-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k203149-must-mini-posterior-cervical-screws-fda-510k.jpg K203149 - M.U.S.T. MINI Posterior Cervical Screws System K203149 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Nov 2020. https://www.510kdatabase.net/k200401/ 2020-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k200401-apogee-fda-510k.jpg K200401 - Apogee K200401 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Incoba Ltd D/B/A Dynaris. Cleared Nov 2020. https://www.510kdatabase.net/k192612/ 2020-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k192612-kerecis-gingiva-graft-fda-510k.jpg K192612 - Kerecis Gingiva Graft K192612 is a FDA 510(k) cleared dental medical device. Manufacturer: Kerecis Limited. Cleared Nov 2020. https://www.510kdatabase.net/k200081/ 2020-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k200081-neuwave-microwave-ablation-system-and-fda-510k.jpg K200081 - NEUWAVE Microwave Ablation System and Accessories K200081 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Neuwave Medical, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k200239/ 2020-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k200239-astroglide-organix-gel-fda-510k.jpg K200239 - Astroglide Organix Gel K200239 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Biofilm, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k200820/ 2020-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k200820-speedicath-compact-set-fda-510k.jpg K200820 - SpeediCath Compact Set K200820 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Coloplast. Cleared Nov 2020. https://www.510kdatabase.net/k201666/ 2020-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k201666-single-use-manometer-fda-510k.jpg K201666 - SINGLE USE MANOMETER K201666 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Flexicare Medical Limited.. Cleared Nov 2020. https://www.510kdatabase.net/k201881/ 2020-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k201881-coroflow-cardiovascular-system-fda-510k.jpg K201881 - CoroFlow Cardiovascular System K201881 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Coroventis Research AB. Cleared Nov 2020. https://www.510kdatabase.net/k201937/ 2020-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k201937-ceramir-restore-quikcap-fda-510k.jpg K201937 - Ceramir Restore QuikCap K201937 is a FDA 510(k) cleared dental medical device. Manufacturer: Doxa Dental AB. Cleared Nov 2020. https://www.510kdatabase.net/k202132/ 2020-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k202132-venue-fda-510k.jpg K202132 - Venue K202132 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared Nov 2020. https://www.510kdatabase.net/k202178/ 2020-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k202178-versaloop-anchor-system-fda-510k.jpg K202178 - VersaLoop Anchor System K202178 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: T.A.G. Medical Products Corporation, Ltd.. Cleared Nov 2020. https://www.510kdatabase.net/k202317/ 2020-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k202317-li-battery-powered-otc-tensems-model-fda-510k.jpg K202317 - Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806 K202317 is a FDA 510(k) cleared neurology medical device. Manufacturer: Everyway Medical Instruments Co.,Ltd. Cleared Nov 2020. https://www.510kdatabase.net/k202355/ 2020-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k202355-stryker-omega-peek-knotless-anchor-fda-510k.jpg K202355 - Stryker Omega PEEK Knotless Anchor System K202355 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker. Cleared Nov 2020. https://www.510kdatabase.net/k202373/ 2020-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k202373-apex-3d-total-ankle-replacement-system-fda-510k.jpg K202373 - APEX 3D Total Ankle Replacement System K202373 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paragon 28, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k202620/ 2020-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k202620-flexcath-advance-steerable-sheath-and-fda-510k.jpg K202620 - FlexCath Advance Steerable Sheath and Dilator K202620 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Cryocath, LP. Cleared Nov 2020. https://www.510kdatabase.net/k202966/ 2020-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k202966-signa-architect-fda-510k.jpg K202966 - SIGNA Architect K202966 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare (Ge Medical Systems, LLC). Cleared Nov 2020. https://www.510kdatabase.net/k203011/ 2020-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k203011-monster-screw-system-fda-510k.jpg K203011 - Monster Screw System K203011 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paragon 28, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k203040/ 2020-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k203040-tsolution-one-total-knee-application-fda-510k.jpg K203040 - TSolution One Total Knee Application K203040 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: THINK Surgical, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/den190029/ 2020-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/den190029-acumen-assisted-fluid-management-afm-fda-510k.jpg DEN190029 - Acumen Assisted Fluid Management (AFM) Software Feature DEN190029 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences. Cleared Nov 2020. https://www.510kdatabase.net/k191433/ 2020-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k191433-agilon-xo-shoulder-replacement-system-fda-510k.jpg K191433 - AGILON® XO Shoulder Replacement System K191433 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Implantcast GmbH. Cleared Nov 2020. https://www.510kdatabase.net/k192978/ 2020-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k192978-eogas-4-ethylene-oxide-gas-sterilizer-fda-510k.jpg K192978 - EOGas 4 Ethylene Oxide Gas Sterilizer K192978 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Andersen Sterilizers, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k192980/ 2020-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k192980-eogas-4-endo-steritest-fda-510k.jpg K192980 - EOGas 4 Endo-SteriTest K192980 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Andersen Sterilizers, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k193289/ 2020-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k193289-faststroke-ct-perfusion-4d-fda-510k.jpg K193289 - FastStroke, CT Perfusion 4D K193289 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems SCS. Cleared Nov 2020. https://www.510kdatabase.net/k193385/ 2020-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k193385-tp-orthodontics-clear-aligner-system-fda-510k.jpg K193385 - TP Orthodontics Clear Aligner System K193385 is a FDA 510(k) cleared dental medical device. Manufacturer: Tp Orthodontics, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k193411/ 2020-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k193411-o2asis-personal-oxygen-humidifier-fda-510k.jpg K193411 - O2asis Personal Oxygen Humidifier K193411 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Perma Pure, LLC. Cleared Nov 2020. https://www.510kdatabase.net/k200334/ 2020-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k200334-an1036-dosimeter-fda-510k.jpg K200334 - AN1036 Dosimeter K200334 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Andersen Sterilizers, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k200335/ 2020-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k200335-sterisheet-sterilization-wrap-fda-510k.jpg K200335 - Sterisheet Sterilization Wrap K200335 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Andersen Sterilizers, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k200336/ 2020-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k200336-tyvek-sterilization-pouches-with-fda-510k.jpg K200336 - Tyvek Sterilization Pouches with Chevron Seal K200336 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Andersen Sterilizers, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k201523/ 2020-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k201523-sharps-container-fda-510k.jpg K201523 - Sharps container K201523 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zhejiang Gongdong Medical Technology Co., Ltd.. Cleared Nov 2020. https://www.510kdatabase.net/k201568/ 2020-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k201568-calvary-spine-pedicle-screw-system-fda-510k.jpg K201568 - Calvary Spine Pedicle Screw System K201568 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Calvary Spine, LLC. Cleared Nov 2020. https://www.510kdatabase.net/k201985/ 2020-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k201985-kardiaai-fda-510k.jpg K201985 - KardiaAI K201985 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: AliveCor, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k202074/ 2020-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k202074-apache-ultrasound-system-model-c62-fda-510k.jpg K202074 - Apache Ultrasound System (Model C62) K202074 is a FDA 510(k) cleared radiology medical device. Manufacturer: Compal Electronics, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k202571/ 2020-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k202571-da-vinci-sp-surgical-system-model-fda-510k.jpg K202571 - da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories K202571 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k203082/ 2020-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k203082-insight-infrared-video-goggles-fda-510k.jpg K203082 - Insight Infrared Video Goggles K203082 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Vestibular First. Cleared Nov 2020. https://www.510kdatabase.net/k203085/ 2020-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k203085-nova-patient-warming-system-fda-510k.jpg K203085 - NOVA Patient Warming System K203085 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Encompass Group, LLC. Cleared Nov 2020. https://www.510kdatabase.net/k203173/ 2020-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k203173-exactrac-dynamic-fda-510k.jpg K203173 - ExacTrac Dynamic K203173 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab AG. Cleared Nov 2020. https://www.510kdatabase.net/k203043/ 2020-11-11 monthly 0.5 https://www.510kdatabase.net/og-image/k203043-route-92-medical-070-access-system-fda-510k.jpg K203043 - Route 92 Medical 070 Access System K203043 is a FDA 510(k) cleared neurology medical device. Manufacturer: Route 92 Medical, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k183044/ 2020-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k183044-jtk-dental-implant-system-fda-510k.jpg K183044 - JTK Dental Implant System K183044 is a FDA 510(k) cleared dental medical device. Manufacturer: Jiangyin Jintech Biotech Co., Ltd.. Cleared Nov 2020. https://www.510kdatabase.net/k193214/ 2020-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k193214-washerloc-and-no-profile-screw-and-fda-510k.jpg K193214 - WasherLoc and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System, Biomet Headless Compression and Twist-Off Screws K193214 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k200098/ 2020-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k200098-vagivital-aktivgel-fda-510k.jpg K200098 - VagiVital Aktivgel K200098 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Peptonic Medical AB. Cleared Nov 2020. https://www.510kdatabase.net/k200428/ 2020-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k200428-multi-drive-interference-screw-system-fda-510k.jpg K200428 - Multi-Drive Interference Screw System K200428 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nvision Biomedical Technologies, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k200886/ 2020-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k200886-stimsite-fda-510k.jpg K200886 - StimSite K200886 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Allotrope Medical, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k201976/ 2020-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k201976-snapshotnir-fda-510k.jpg K201976 - SnapshotNIR K201976 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Kent Imaging. Cleared Nov 2020. https://www.510kdatabase.net/k203106/ 2020-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k203106-nio-fusion-12mp-mdnc-12130-fda-510k.jpg K203106 - Nio Fusion 12MP (MDNC-12130) K203106 is a FDA 510(k) cleared radiology medical device. Manufacturer: Barco N.V.. Cleared Nov 2020. https://www.510kdatabase.net/k193190/ 2020-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k193190-bd-purehub-disinfecting-cap-fda-510k.jpg K193190 - BD PureHub Disinfecting Cap K193190 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson and Company. Cleared Nov 2020. https://www.510kdatabase.net/k193432/ 2020-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k193432-vantage-psi-system-fda-510k.jpg K193432 - Vantage PSI System K193432 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 3D Systems. Cleared Nov 2020. https://www.510kdatabase.net/k200005/ 2020-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k200005-concinnity-aligners-fda-510k.jpg K200005 - Concinnity Aligners K200005 is a FDA 510(k) cleared dental medical device. Manufacturer: Drake Precision Dental Laboratory, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k201269/ 2020-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k201269-accula-strep-a-test-fda-510k.jpg K201269 - Accula Strep A Test K201269 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Mesa Biotech, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k201431/ 2020-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k201431-ogyili-tensnmes-stimulator-fda-510k.jpg K201431 - OGYILI TENS/NMES Stimulator K201431 is a FDA 510(k) cleared neurology medical device. Manufacturer: Gongguan Tutamen Metalwork Co., Ltd.. Cleared Nov 2020. https://www.510kdatabase.net/k201990/ 2020-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k201990-dc-30dc-32dc-28dc-26dc-25dc-20dc-30-fda-510k.jpg K201990 - DC-30/DC-32/DC-28/DC-26/DC-25/DC-20/DC-30 Exp/DC-32 Exp Diagnostic Ultrasound System K201990 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Nov 2020. https://www.510kdatabase.net/k202274/ 2020-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k202274-nalu-neurostimulation-kit-lntegmted-40-fda-510k.jpg K202274 - Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 em: Single 8/Dual8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 ern Kil, 40 cm/ 60 cm/60 em TrialJExtension Lead Kits, Patient Kits and miscellaneous replacement kits K202274 is a FDA 510(k) cleared neurology medical device. Manufacturer: Boston Scientific Neuromodulation. Cleared Nov 2020. https://www.510kdatabase.net/k203110/ 2020-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k203110-ifuse-implant-system-ifuse-navigation-fda-510k.jpg K203110 - iFuse Implant System - iFuse Navigation K203110 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SI-BONE, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k203128/ 2020-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k203128-evis-eus-endoscopic-ultrasound-center-fda-510k.jpg K203128 - EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2/EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2 PREMIER PLUS K203128 is a FDA 510(k) cleared radiology medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Nov 2020. https://www.510kdatabase.net/k192621/ 2020-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k192621-medical-rf-fda-510k.jpg K192621 - Medical RF K192621 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Triworks Group Srl. Cleared Nov 2020. https://www.510kdatabase.net/k193562/ 2020-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k193562-ai-rad-companion-organs-rt-fda-510k.jpg K193562 - AI-Rad Companion Organs RT K193562 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k200077/ 2020-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k200077-biomin-restore-plus-fda-510k.jpg K200077 - BioMin Restore Plus K200077 is a FDA 510(k) cleared dental medical device. Manufacturer: Dr. Collins, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k200672/ 2020-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k200672-durex-penck-standard-durex-penck-xl-fda-510k.jpg K200672 - Durex Penck Standard, Durex Penck XL K200672 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Rb Health (Us), LLC. Cleared Nov 2020. https://www.510kdatabase.net/k200750/ 2020-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k200750-neuroal-algorithm-fda-510k.jpg K200750 - Neuro.Al Algorithm K200750 is a FDA 510(k) cleared radiology medical device. Manufacturer: Terarecon,Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k200811/ 2020-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k200811-cobas-u-701-microscopy-analyzer-fda-510k.jpg K200811 - cobas u 701 microscopy analyzer K200811 is a FDA 510(k) cleared hematology medical device. Manufacturer: Roche Diagnostics. Cleared Nov 2020. https://www.510kdatabase.net/k201091/ 2020-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k201091-v-print-splint-fda-510k.jpg K201091 - V-Print splint K201091 is a FDA 510(k) cleared dental medical device. Manufacturer: Voco GmbH. Cleared Nov 2020. https://www.510kdatabase.net/k201669/ 2020-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k201669-simplesense-fda-510k.jpg K201669 - SimpleSENSE K201669 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nanowear, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k202427/ 2020-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k202427-aqueduct-100-plus-cervical-dilation-fda-510k.jpg K202427 - Aqueduct 100 Plus Cervical Dilation Balloon Catheter K202427 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Gtimd, LLC. Cleared Nov 2020. https://www.510kdatabase.net/k202583/ 2020-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k202583-bioshield-biopsy-valve-eus-linear-fda-510k.jpg K202583 - BioShield biopsy valve EUS - Linear K202583 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: STERIS Corporation. Cleared Nov 2020. https://www.510kdatabase.net/k202587/ 2020-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k202587-atec-lateral-interbody-system-fda-510k.jpg K202587 - ATEC Lateral Interbody System K202587 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k202589/ 2020-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k202589-aptus-cannulated-compression-screws-fda-510k.jpg K202589 - APTUS Cannulated Compression Screws, APTUS headed Cannulated Compression Screws, APTUS K-Wire System K202589 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medartis AG. Cleared Nov 2020. https://www.510kdatabase.net/k202664/ 2020-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k202664-clio-prime-and-clio-pedo-fda-510k.jpg K202664 - Clio Prime and Clio Pedo K202664 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sota Precision Optics, Inc. Dba Sota Imaging. Cleared Nov 2020. https://www.510kdatabase.net/k203061/ 2020-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k203061-amsco-evolution-medium-steam-fda-510k.jpg K203061 - Amsco Evolution Medium Steam Sterilizer (Models HC-900 and HC-1200),Evolution Automated Loading and Unloading System (ALUS) K203061 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Nov 2020. https://www.510kdatabase.net/k203076/ 2020-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k203076-mecta-c-stand-alone-extension-fda-510k.jpg K203076 - Mecta-C Stand Alone Extension K203076 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Nov 2020. https://www.510kdatabase.net/den200033/ 2020-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/den200033-nightware-kit-apple-iphone-apple-watch-fda-510k.jpg DEN200033 - NightWare Kit, Apple iPhone, Apple Watch, Apple iPhone Charging Cable, Apple Watch Charging Cable DEN200033 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nightware, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k200017/ 2020-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k200017-eclipse-dermaflex-cannula-fda-510k.jpg K200017 - Eclipse DermaFlex Cannula K200017 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Eclipse Medcorp, LLC. Cleared Nov 2020. https://www.510kdatabase.net/k201741/ 2020-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k201741-gabriel-3-way-enfit-valve-fda-510k.jpg K201741 - Gabriel 3 Way EnFit Valve K201741 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Syncro Medical Innovations, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k201827/ 2020-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k201827-gr-17-resin-system-fda-510k.jpg K201827 - GR-17 Resin System K201827 is a FDA 510(k) cleared dental medical device. Manufacturer: Pro3dure Medical GmbH. Cleared Nov 2020. https://www.510kdatabase.net/k201877/ 2020-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k201877-otoset-ear-cleaning-system-fda-510k.jpg K201877 - OtoSet- Ear Cleaning System K201877 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Safkan, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k201902/ 2020-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k201902-mammaprint-fda-510k.jpg K201902 - MammaPrint K201902 is a FDA 510(k) cleared pathology medical device. Manufacturer: Agendia, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k202244/ 2020-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k202244-spy-phi-system-with-spy-phi-fda-510k.jpg K202244 - SPY-PHI System with SPY-PHI Fluorescence Assessment Software K202244 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Novadaq Technologies Ulc. (Now A Part of Stryker). Cleared Nov 2020. https://www.510kdatabase.net/k202476/ 2020-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k202476-salvo-spine-system-fda-510k.jpg K202476 - Salvo® Spine System K202476 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spine Wave, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k203025/ 2020-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k203025-lobo-vascular-occlusion-system-model-fda-510k.jpg K203025 - LOBO Vascular Occlusion System (model LOBO-5) K203025 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Okami Medical. Cleared Nov 2020. https://www.510kdatabase.net/k203154/ 2020-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k203154-kasilof-cervical-plate-system-fda-510k.jpg K203154 - KASILOF Cervical Plate System K203154 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Kahtnu Surgical, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k182084/ 2020-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k182084-sweden-martina-surgical-tray-model-fda-510k.jpg K182084 - Sweden & Martina Surgical Tray (Model ZSHORTY-INT) K182084 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sweden & Martina S.P.A.. Cleared Nov 2020. https://www.510kdatabase.net/k193499/ 2020-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k193499-digiguide-system-fda-510k.jpg K193499 - DigiGuide System K193499 is a FDA 510(k) cleared dental medical device. Manufacturer: Protomed, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k200350/ 2020-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k200350-myhip-planner-verifier-fda-510k.jpg K200350 - MyHip Planner & Verifier K200350 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medacta International S.A.. Cleared Nov 2020. https://www.510kdatabase.net/k201840/ 2020-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k201840-aurora-surgiscope-system-surgiscope-fda-510k.jpg K201840 - Aurora Surgiscope System (Surgiscope), Aurora Surgiscope System (Image Control Box) K201840 is a FDA 510(k) cleared neurology medical device. Manufacturer: Rebound Therapeutics. Cleared Nov 2020. https://www.510kdatabase.net/k201941/ 2020-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k201941-monitor-b125-monitor-b105-fda-510k.jpg K201941 - Monitor B125, Monitor B105 K201941 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k202422/ 2020-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k202422-arietta-65-fda-510k.jpg K202422 - Arietta 65 K202422 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hitachi Healthcare Americas. Cleared Nov 2020. https://www.510kdatabase.net/k202581/ 2020-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k202581-arthrex-tightrope-ii-fda-510k.jpg K202581 - Arthrex TightRope II K202581 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k202624/ 2020-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k202624-z-span-plate-system-fda-510k.jpg K202624 - Z-Span Plate System K202624 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zavation Medical Products, LLC. Cleared Nov 2020. https://www.510kdatabase.net/k191940/ 2020-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k191940-palm-nrg-cellulite-and-muscle-toning-fda-510k.jpg K191940 - Palm NRG cellulite and muscle toning body device K191940 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Heat IN A Click. Cleared Nov 2020. https://www.510kdatabase.net/k200071/ 2020-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k200071-blue-beacon-submucosal-injectable-fda-510k.jpg K200071 - Blue Beacon Submucosal Injectable Solution K200071 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Micro-Tech (Nanjing) Co., Ltd.. Cleared Nov 2020. https://www.510kdatabase.net/k201683/ 2020-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k201683-pmma-block-fda-510k.jpg K201683 - PMMA Block K201683 is a FDA 510(k) cleared dental medical device. Manufacturer: Huge Dental Material Co., Ltd.. Cleared Nov 2020. https://www.510kdatabase.net/k202198/ 2020-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k202198-flarehawk-interbody-fusion-system-fda-510k.jpg K202198 - FlareHawk Interbody Fusion System K202198 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Integrity Implants, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k192618/ 2020-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k192618-e-motion-m25-fda-510k.jpg K192618 - e-Motion M25 K192618 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Alber GmbH. Cleared Nov 2020. https://www.510kdatabase.net/k192904/ 2020-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k192904-speedicath-compact-set-fda-510k.jpg K192904 - SpeediCath Compact Set K192904 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Coloplast. Cleared Nov 2020. https://www.510kdatabase.net/k202552/ 2020-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k202552-midas-rex-attachments-and-dissecting-fda-510k.jpg K202552 - Midas Rex Attachments and Dissecting Tools K202552 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Powered Surgical Solutions (Mpss). Cleared Nov 2020. https://www.510kdatabase.net/k202558/ 2020-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k202558-ellusa-bipolar-wands-fda-510k.jpg K202558 - Ellusa Bipolar Wands K202558 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ellusa, LLC. Cleared Nov 2020. https://www.510kdatabase.net/k202562/ 2020-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k202562-ellusa-generator-ellusa-bayonet-tip-fda-510k.jpg K202562 - Ellusa Generator, Ellusa Bayonet Tip, Ellusa RF-Cobb Tip, Ellusa SP-Pack and Tips, Ellusa Tip Set K202562 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ellusa, LLC. Cleared Nov 2020. https://www.510kdatabase.net/k203032/ 2020-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k203032-icepearl-21-cx-90-needle-icepearl-21-fda-510k.jpg K203032 - IcePearl 2.1 CX 90° Needle, IcePearl 2.1 CX L 90° Needle, IcePearl 2.1 CX Needle, IceFORCE 2.1 CX 90° Needle, IceFORCE 2.1 CX L 90° Needle, IceFORCE 2.1 CX Needle K203032 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Galil Medical, Inc.. Cleared Nov 2020. https://www.510kdatabase.net/k193296/ 2020-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k193296-ecordum-cardiac-monitor-ecordum-cm-fda-510k.jpg K193296 - eCordum Cardiac Monitor (eCordum CM) K193296 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ecordum, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k193421/ 2020-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k193421-smart-alarm-interface-fda-510k.jpg K193421 - Smart Alarm Interface K193421 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boxview, LLC. Cleared Oct 2020. https://www.510kdatabase.net/k200190/ 2020-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k200190-scalpelcric-fda-510k.jpg K200190 - ScalpelCric K200190 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: VBM Medizintechnik GmbH. Cleared Oct 2020. https://www.510kdatabase.net/k200316/ 2020-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k200316-unid-ib3d-alif-fda-510k.jpg K200316 - UNiD IB3D ALIF K200316 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medicrea International SA. Cleared Oct 2020. https://www.510kdatabase.net/k200323/ 2020-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k200323-autocontour-fda-510k.jpg K200323 - AutoContour K200323 is a FDA 510(k) cleared radiology medical device. Manufacturer: Radformation, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k201695/ 2020-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k201695-patent-hemostasis-band-ph-band-fda-510k.jpg K201695 - Patent Hemostasis Band (PH Band) K201695 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medical Ingenuities. Cleared Oct 2020. https://www.510kdatabase.net/k201988/ 2020-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k201988-t-lite-fda-510k.jpg K201988 - T-Lite K201988 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sonoscanner. Cleared Oct 2020. https://www.510kdatabase.net/k202013/ 2020-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k202013-wrdensity-by-whiterabbitai-fda-510k.jpg K202013 - WRDensity by Whiterabbit.ai K202013 is a FDA 510(k) cleared radiology medical device. Manufacturer: Whiterabbit.Ai, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k202157/ 2020-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k202157-pico-7-single-use-negative-pressure-fda-510k.jpg K202157 - PICO 7 Single Use Negative Pressure Wound Therapy System, PICO 7Y Single Use Negative Pressure Wound Therapy System, PICO 14 Single Use Negative Pressure Wound Therapy System, PICO Fluid Management Pack K202157 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew Medical Limited. Cleared Oct 2020. https://www.510kdatabase.net/k202302/ 2020-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k202302-atlas-spine-rebar-ti-spacer-system-fda-510k.jpg K202302 - Atlas Spine Rebar (Ti) Spacer System K202302 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Atlas Spine, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k202497/ 2020-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k202497-aulisa-multiple-patient-digital-vital-fda-510k.jpg K202497 - Aulisa Multiple Patient Digital Vital Sign Monitoring System K202497 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Taiwan Aulisa Medical Devices Technologies, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k202556/ 2020-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k202556-hs30-diagnostic-ultrasound-system-fda-510k.jpg K202556 - HS30 Diagnostic Ultrasound System K202556 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Medison Co., Ltd.. Cleared Oct 2020. https://www.510kdatabase.net/k202901/ 2020-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k202901-longeviti-clearfit-cranial-implant-fda-510k.jpg K202901 - Longeviti ClearFit Cranial Implant K202901 is a FDA 510(k) cleared neurology medical device. Manufacturer: Longeviti Neuro Solutions, LLC. Cleared Oct 2020. https://www.510kdatabase.net/k202938/ 2020-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k202938-aesculap-caiman-5-seal-and-cut-fda-510k.jpg K202938 - Aesculap Caiman 5 Seal and Cut Technology System K202938 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k203007/ 2020-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k203007-ekuore-pro-series-fda-510k.jpg K203007 - eKuore Pro Series K203007 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Chip Ideas Electronics S.L.. Cleared Oct 2020. https://www.510kdatabase.net/k203028/ 2020-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k203028-fujifilm-distal-end-cap-fda-510k.jpg K203028 - FUJIFILM Distal End Cap K203028 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fujifilm Corporation. Cleared Oct 2020. https://www.510kdatabase.net/k192282/ 2020-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k192282-medcad-accuplan-system-fda-510k.jpg K192282 - MedCAD® AccuPlan® System K192282 is a FDA 510(k) cleared dental medical device. Manufacturer: Medcad. Cleared Oct 2020. https://www.510kdatabase.net/k192989/ 2020-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k192989-libertas-e-xlpe-modular-liner-fda-510k.jpg K192989 - Libertas E-XLPE Modular Liner K192989 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Maxx Orthopedics, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k193090/ 2020-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k193090-hcg-zirconia-ceramic-block-fda-510k.jpg K193090 - HCG Zirconia Ceramic Block K193090 is a FDA 510(k) cleared dental medical device. Manufacturer: Hocheng Corporation. Cleared Oct 2020. https://www.510kdatabase.net/k193169/ 2020-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k193169-nelson-sentinel-series-basic-chlorine-fda-510k.jpg K193169 - Nelson Sentinel Series Basic Chlorine Sentinel K193169 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Nelson Environmental Technologies, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k193206/ 2020-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k193206-wizard-510-nasal-mask-fda-510k.jpg K193206 - WiZARD 510 Nasal Mask K193206 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Apex Medical Corp.. Cleared Oct 2020. https://www.510kdatabase.net/k200088/ 2020-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k200088-gestim-fes-fda-510k.jpg K200088 - g.Estim FES K200088 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: G.Tec Medical Engineering GmbH. Cleared Oct 2020. https://www.510kdatabase.net/k200299/ 2020-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k200299-curos-jet-disinfecting-cap-fda-510k.jpg K200299 - Curos Jet Disinfecting Cap K200299 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Oct 2020. https://www.510kdatabase.net/k200332/ 2020-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k200332-expert-joint-fixation-system-fda-510k.jpg K200332 - EXPERT - Joint Fixation System K200332 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: GM Dos Reis Industria e Comercio Ltda.. Cleared Oct 2020. https://www.510kdatabase.net/k200425/ 2020-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k200425-female-luer-lock-cap-fda-510k.jpg K200425 - Female Luer Lock Cap K200425 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medsafety Solutions, LLC. Cleared Oct 2020. https://www.510kdatabase.net/k201092/ 2020-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k201092-lsn-fda-510k.jpg K201092 - LSN K201092 is a FDA 510(k) cleared radiology medical device. Manufacturer: Imaging Biometrics, LLC. Cleared Oct 2020. https://www.510kdatabase.net/k201692/ 2020-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k201692-nuvasive-modulus-xlif-interbody-system-fda-510k.jpg K201692 - NuVasive Modulus XLIF Interbody System K201692 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Oct 2020. https://www.510kdatabase.net/k202105/ 2020-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k202105-osteomed-extremifix-mini-small-system-fda-510k.jpg K202105 - OsteoMed ExtremiFix Mini & Small System Tray K202105 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Osteomed, LLC. Cleared Oct 2020. https://www.510kdatabase.net/k202142/ 2020-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k202142-sleepware-g3-fda-510k.jpg K202142 - Sleepware G3 K202142 is a FDA 510(k) cleared neurology medical device. Manufacturer: Respironics, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k202496/ 2020-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k202496-anthem-fracture-system-fda-510k.jpg K202496 - ANTHEM Fracture System K202496 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k202539/ 2020-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k202539-nutriglidetm-nasal-feeding-tube-fda-510k.jpg K202539 - Nutriglide(TM) Nasal Feeding Tube K202539 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Applied Medical Technology, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k202646/ 2020-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k202646-visera-elite-ii-video-system-center-fda-510k.jpg K202646 - Visera Elite II Video System Center K202646 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Oct 2020. https://www.510kdatabase.net/k202912/ 2020-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k202912-arix-ankle-distal-tibia-system-fda-510k.jpg K202912 - ARIX Ankle Distal Tibia System K202912 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Jeil Medical Corporation. Cleared Oct 2020. https://www.510kdatabase.net/k202949/ 2020-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k202949-construx-mini-peek-spacer-system-fda-510k.jpg K202949 - CONSTRUX Mini PEEK Spacer System K202949 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthofix, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k202957/ 2020-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k202957-flexible-video-cysto-urethroscope-c-view-fda-510k.jpg K202957 - Flexible Video Cysto-Urethroscope (C-view) K202957 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k203058/ 2020-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k203058-cloudvue-fda-510k.jpg K203058 - CloudVue K203058 is a FDA 510(k) cleared radiology medical device. Manufacturer: International Medical Solutions, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k193038/ 2020-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k193038-comprehensive-shoulder-system-fda-510k.jpg K193038 - Comprehensive Shoulder System K193038 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet Manufacturing Corp. Cleared Oct 2020. https://www.510kdatabase.net/k200003/ 2020-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k200003-np1-instrument-creo-electrosurgical-fda-510k.jpg K200003 - NP1 Instrument, Creo Electrosurgical System K200003 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Creo Medical, Ltd.. Cleared Oct 2020. https://www.510kdatabase.net/k200125/ 2020-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k200125-thermoforming-sheet-materials-fda-510k.jpg K200125 - Thermoforming Sheet Materials K200125 is a FDA 510(k) cleared dental medical device. Manufacturer: Erkodent Erich Kopp GmbH. Cleared Oct 2020. https://www.510kdatabase.net/k200153/ 2020-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k200153-bright-bond-universal-fda-510k.jpg K200153 - Bright Bond Universal K200153 is a FDA 510(k) cleared dental medical device. Manufacturer: Genoss Co., Ltd.. Cleared Oct 2020. https://www.510kdatabase.net/k200759/ 2020-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k200759-nim-vital-nerve-integrity-monitor-fda-510k.jpg K200759 - NIM Vital, Nerve Integrity Monitor K200759 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Xomed, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k200790/ 2020-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k200790-lnk-spinal-fixation-system-openloc-l-fda-510k.jpg K200790 - LnK Spinal Fixation System, OpenLoc-L Spinal Fixation System K200790 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: L & K Biomed Co., Ltd.. Cleared Oct 2020. https://www.510kdatabase.net/k201395/ 2020-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k201395-sterile-high-pressure-angiographic-fda-510k.jpg K201395 - Sterile High-pressure Angiographic Syringes for single-use K201395 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Youwo (Guangzhou) Medical Device Co., Ltd.. Cleared Oct 2020. https://www.510kdatabase.net/k201475/ 2020-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k201475-ultimate-contour-ultimate-contour-mini-fda-510k.jpg K201475 - Ultimate Contour, Ultimate Contour Mini K201475 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: CAO Group, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k201497/ 2020-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k201497-evos-cabling-system-fda-510k.jpg K201497 - EVOS Cabling System K201497 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.). Cleared Oct 2020. https://www.510kdatabase.net/k202089/ 2020-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k202089-lenshooke-x1-pro-semen-quality-fda-510k.jpg K202089 - LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer K202089 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bonraybio Co., Ltd.. Cleared Oct 2020. https://www.510kdatabase.net/k202259/ 2020-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k202259-parcus-gfs-ii-and-gfs-mini-gfs-naked-fda-510k.jpg K202259 - Parcus GFS II and GFS Mini, GFS Naked, GFS Ultimate, GFS BTB, ATLAS, Synd-EZ Ti, Actiflip Naked, Actiflip Cinch, Actiflip Whip, and GFS Ultimate Hip K202259 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Parcus Medical, LLC. Cleared Oct 2020. https://www.510kdatabase.net/k202864/ 2020-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k202864-tri-staple-20-reloads-fda-510k.jpg K202864 - Tri-Staple 2.0 Reloads K202864 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien. Cleared Oct 2020. https://www.510kdatabase.net/k202935/ 2020-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k202935-syntec-femoral-nail-extended-system-fda-510k.jpg K202935 - Syntec Femoral Nail Extended System K202935 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Syntec Scientific Corporation. Cleared Oct 2020. https://www.510kdatabase.net/k193084/ 2020-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k193084-tib-abutment-system-fda-510k.jpg K193084 - TIB Abutment System K193084 is a FDA 510(k) cleared dental medical device. Manufacturer: Southern Implants (Pty), Ltd.. Cleared Oct 2020. https://www.510kdatabase.net/k200156/ 2020-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k200156-bright-low-flow-fda-510k.jpg K200156 - Bright Low Flow K200156 is a FDA 510(k) cleared dental medical device. Manufacturer: Genoss Co., Ltd.. Cleared Oct 2020. https://www.510kdatabase.net/k200273/ 2020-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k200273-freeprint-temp-fda-510k.jpg K200273 - FREEPRINT temp K200273 is a FDA 510(k) cleared dental medical device. Manufacturer: Detax GmbH & Co. KG. Cleared Oct 2020. https://www.510kdatabase.net/k201627/ 2020-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k201627-dental-computed-tomography-x-ray-fda-510k.jpg K201627 - Dental Computed Tomography X-Ray System, Green X K201627 is a FDA 510(k) cleared radiology medical device. Manufacturer: VATECH Co., Ltd.. Cleared Oct 2020. https://www.510kdatabase.net/k202152/ 2020-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k202152-nextar-tka-platform-fda-510k.jpg K202152 - NextAR TKA Platform K202152 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Oct 2020. https://www.510kdatabase.net/k202519/ 2020-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k202519-orthonext-platform-system-fda-510k.jpg K202519 - OrthoNext Platform System K202519 is a FDA 510(k) cleared radiology medical device. Manufacturer: Orthofix Srl. Cleared Oct 2020. https://www.510kdatabase.net/k202887/ 2020-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k202887-illuminoss-bone-stabilization-system-fda-510k.jpg K202887 - IlluminOss Bone Stabilization System K202887 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Illuminoss Medical, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k202960/ 2020-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k202960-general-cutting-contra-handpiece-fda-510k.jpg K202960 - General Cutting Contra Handpiece K202960 is a FDA 510(k) cleared dental medical device. Manufacturer: Nakanishi, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k203005/ 2020-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k203005-mazor-x-fda-510k.jpg K203005 - Mazor X K203005 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Mazor Robotics , Ltd.. Cleared Oct 2020. https://www.510kdatabase.net/k203099/ 2020-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k203099-triathlon-pkr-system-fda-510k.jpg K203099 - Triathlon PKR System K203099 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. Cleared Oct 2020. https://www.510kdatabase.net/k200150/ 2020-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k200150-medline-powder-free-orange-nitrile-fda-510k.jpg K200150 - Medline Powder-Free Orange Nitrile Patient Examination Glove (Tested for use with Fentanyl) K200150 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k200937/ 2020-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k200937-acura-stabilization-system-fda-510k.jpg K200937 - ACURA Stabilization System K200937 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Indius Medical Technologies Pvt. , Ltd.. Cleared Oct 2020. https://www.510kdatabase.net/k201811/ 2020-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k201811-coraforce-and-coraflex-support-catheters-fda-510k.jpg K201811 - coraForce and coraFlex Support Catheters K201811 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Reflow Medical, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k202065/ 2020-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k202065-dolomite-anterior-cervical-fda-510k.jpg K202065 - DOLOMITE Anterior Cervical Stabilization System K202065 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Astura Medical, LLC. Cleared Oct 2020. https://www.510kdatabase.net/k202179/ 2020-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k202179-medline-glide-on-3g-vinyl-examination-fda-510k.jpg K202179 - Medline Glide-On 3G Vinyl Examination Gloves (Tested for use with Chemotherapy Drugs) K202179 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k202469/ 2020-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k202469-g-eye-system-fda-510k.jpg K202469 - G-EYE System K202469 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Smart Medical Systems , Ltd.. Cleared Oct 2020. https://www.510kdatabase.net/k202489/ 2020-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k202489-aos-fibonacci-lower-extremity-plating-fda-510k.jpg K202489 - AOS Fibonacci Lower Extremity Plating System – AOS Proximal Tibia Plating System K202489 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Advanced Orthopaedic Solutions, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k202528/ 2020-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k202528-cannulated-power-driver-attachment-fda-510k.jpg K202528 - Cannulated Power Driver Attachment K202528 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: K2m, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k202722/ 2020-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k202722-1212fca-fda-510k.jpg K202722 - 1212FCA K202722 is a FDA 510(k) cleared radiology medical device. Manufacturer: Rayence Co., Ltd.. Cleared Oct 2020. https://www.510kdatabase.net/k201335/ 2020-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k201335-li-battery-powered-otc-tensems-fda-510k.jpg K201335 - Li-Battery powered OTC TENS/EMS Combination Stimulator K201335 is a FDA 510(k) cleared neurology medical device. Manufacturer: Everyway Medical Instruments Co.,Ltd. Cleared Oct 2020. https://www.510kdatabase.net/k192317/ 2020-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k192317-planmed-clarity-2d-and-clarity-s-fda-510k.jpg K192317 - Planmed Clarity 2D and Clarity S K192317 is a FDA 510(k) cleared radiology medical device. Manufacturer: Planmed OY. Cleared Oct 2020. https://www.510kdatabase.net/k192811/ 2020-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k192811-benestatm-tissue-removal-device-fda-510k.jpg K192811 - BenestaTM Tissue Removal Device K192811 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Caldera Medical, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k193088/ 2020-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k193088-maxzero-extension-sets-with-needle-fda-510k.jpg K193088 - MaxZero Extension Sets with Needle-Free Connector(s) K193088 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Carefusion, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k193357/ 2020-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k193357-v-mix-fda-510k.jpg K193357 - V-Mix K193357 is a FDA 510(k) cleared dental medical device. Manufacturer: Inter-Med/Vista Dental Products. Cleared Oct 2020. https://www.510kdatabase.net/k193556/ 2020-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k193556-cryocheck-hex-la-fda-510k.jpg K193556 - Cryocheck Hex LA K193556 is a FDA 510(k) cleared hematology medical device. Manufacturer: Precision Biologic. Cleared Oct 2020. https://www.510kdatabase.net/k200109/ 2020-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k200109-oxy-1-system-fda-510k.jpg K200109 - OXY-1 System K200109 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abiomed, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k200223/ 2020-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k200223-pocketdoc-micro-wound-therapy-system-fda-510k.jpg K200223 - PocketDoc™ Micro Wound Therapy System K200223 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Pensar Medical, LLC. Cleared Oct 2020. https://www.510kdatabase.net/k200249/ 2020-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k200249-sequential-culture-media-fertilization-fda-510k.jpg K200249 - Sequential Culture Media (Fertilization Medium [without HSA/rHA, with HSA, with rHA], Cleavage Medium [without HSA/rHA, with HSA, with rHA], Blastocyst Medium [without HSA/rHA, with HSA, with rHA]) K200249 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Kitazato Corporation. Cleared Oct 2020. https://www.510kdatabase.net/k201824/ 2020-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k201824-nerivio-fda-510k.jpg K201824 - Nerivio K201824 is a FDA 510(k) cleared neurology medical device. Manufacturer: Theranica Bio-Electronics, Ltd.. Cleared Oct 2020. https://www.510kdatabase.net/k201843/ 2020-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k201843-infrared-ear-and-forehead-thermometer-fda-510k.jpg K201843 - Infrared ear and forehead thermometer, model YI-100 K201843 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wenzhou Yosun Medical Technology Co.,Ltd. Cleared Oct 2020. https://www.510kdatabase.net/k202071/ 2020-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k202071-surgiphor-wound-irrigation-system-fda-510k.jpg K202071 - SURGIPHOR Wound Irrigation System K202071 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Orthophor, LLC. Cleared Oct 2020. https://www.510kdatabase.net/k202392/ 2020-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k202392-sir-spheres-microspheres-activity-fda-510k.jpg K202392 - SIR-Spheres Microspheres Activity Calculator (SMAC) K202392 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sirtex Medical US Holdings, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k202429/ 2020-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k202429-mobio-total-knee-system-fda-510k.jpg K202429 - Mobio Total Knee System K202429 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: B-One Ortho, Corp.. Cleared Oct 2020. https://www.510kdatabase.net/k202797/ 2020-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k202797-drakon-and-sequre-microcatheters-fda-510k.jpg K202797 - Drakon and Sequre Microcatheters K202797 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Accurate Medical Therapeutics, Ltd.. Cleared Oct 2020. https://www.510kdatabase.net/k202894/ 2020-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k202894-wiltrom-spinal-fixation-system-fda-510k.jpg K202894 - Wiltrom Spinal Fixation System K202894 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wiltrom Corporation Limited. Cleared Oct 2020. https://www.510kdatabase.net/k193623/ 2020-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k193623-dionavi-denture-fda-510k.jpg K193623 - DIOnavi-Denture K193623 is a FDA 510(k) cleared dental medical device. Manufacturer: Dio Corporation. Cleared Oct 2020. https://www.510kdatabase.net/k200318/ 2020-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k200318-unidrive-s-ii-ent-drillcut-x-ii-35-fda-510k.jpg K200318 - UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver Handpiece K200318 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k201768/ 2020-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k201768-voluson-e10-fda-510k.jpg K201768 - Voluson E10 K201768 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Oct 2020. https://www.510kdatabase.net/k202180/ 2020-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k202180-broncoflex-agile-fda-510k.jpg K202180 - Broncoflex Agile K202180 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Axess Vision Technology. Cleared Oct 2020. https://www.510kdatabase.net/k202428/ 2020-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k202428-acupulse-w-co2-laser-systems-delivery-fda-510k.jpg K202428 - AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories K202428 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lumenis, Ltd.. Cleared Oct 2020. https://www.510kdatabase.net/k202817/ 2020-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k202817-geo-bone-screw-system-fda-510k.jpg K202817 - GEO Bone Screw System K202817 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Gramercy Extremity Orthopedics, LLC. Cleared Oct 2020. https://www.510kdatabase.net/k202948/ 2020-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k202948-ezortho-fda-510k.jpg K202948 - EzOrtho K202948 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ewoosoft Co., Ltd.. Cleared Oct 2020. https://www.510kdatabase.net/k192771/ 2020-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k192771-c4-fiducial-marker-fda-510k.jpg K192771 - C4 Fiducial Marker K192771 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C4 Imaging, LLC. Cleared Oct 2020. https://www.510kdatabase.net/k193552/ 2020-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k193552-innovamatrix-fda-510k.jpg K193552 - InnovaMatrix K193552 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Triad Life Sciences, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k200507/ 2020-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k200507-pro-dense-lovisc-bone-graft-substitute-fda-510k.jpg K200507 - PRO-DENSE LoVisc Bone Graft Substitute K200507 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Oct 2020. https://www.510kdatabase.net/k201155/ 2020-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k201155-pleurx-peritoneal-catheter-system-fda-510k.jpg K201155 - PleurX Peritoneal Catheter System K201155 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Care Fusion. Cleared Oct 2020. https://www.510kdatabase.net/k201268/ 2020-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k201268-ethos-aquell-hioxifilcon-a-one-day-fda-510k.jpg K201268 - Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) K201268 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Plexus Optix, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k201415/ 2020-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k201415-vial2bag-advanced-20mm-admixture-device-fda-510k.jpg K201415 - Vial2Bag Advanced 20mm Admixture Device K201415 is a FDA 510(k) cleared general hospital medical device. Manufacturer: West Pharmaceutical Services Az, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k201427/ 2020-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k201427-trivergent-spinal-fixation-system-fda-510k.jpg K201427 - Trivergent Spinal Fixation System K201427 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Benvenue Medical, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k201438/ 2020-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k201438-asi-automated-rpr-rapid-plasma-reagin-fda-510k.jpg K201438 - ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer K201438 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Arlington Scientific, Inc. (Asi). Cleared Oct 2020. https://www.510kdatabase.net/k201610/ 2020-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k201610-ionicrf-generator-fda-510k.jpg K201610 - IonicRF Generator K201610 is a FDA 510(k) cleared neurology medical device. Manufacturer: Abbott Medical. Cleared Oct 2020. https://www.510kdatabase.net/k201670/ 2020-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k201670-ysio-xpree-fda-510k.jpg K201670 - YSIO X.pree K201670 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k201688/ 2020-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k201688-sin-instrument-kits-fda-510k.jpg K201688 - S.I.N. Instrument Kits K201688 is a FDA 510(k) cleared general hospital medical device. Manufacturer: S.I.N. ? Sistema DE Implante Nacional S.A.. Cleared Oct 2020. https://www.510kdatabase.net/k201724/ 2020-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k201724-pentacam-axl-wave-fda-510k.jpg K201724 - Pentacam AXL Wave K201724 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Oculus Optikgerate GmbH. Cleared Oct 2020. https://www.510kdatabase.net/k201884/ 2020-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k201884-renew-xr-handpiece-renew-xr-handpiece-fda-510k.jpg K201884 - ReNew XR Handpiece, ReNew XR Handpiece 34cm, ReNew XR Handpiece 42cm, ReNew XR Handpiece 25cm, Ratcheted ReNew XR Handpiece 34cm K201884 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Microline Surgical, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k202030/ 2020-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k202030-oasis-mri-system-fda-510k.jpg K202030 - OASIS MRI System K202030 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hitachi Healthcare Americas. Cleared Oct 2020. https://www.510kdatabase.net/k202044/ 2020-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k202044-powerpress-recovery-unit-fda-510k.jpg K202044 - Powerpress Recovery Unit K202044 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Hanuri Distribution, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k202472/ 2020-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k202472-actis-duofix-hip-prosthesis-fda-510k.jpg K202472 - ACTIS Duofix Hip Prosthesis K202472 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k202760/ 2020-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k202760-iridex-810-laser-fda-510k.jpg K202760 - Iridex 810 Laser K202760 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Iridex Corporation. Cleared Oct 2020. https://www.510kdatabase.net/k202799/ 2020-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k202799-eva15-fda-510k.jpg K202799 - EVA15 K202799 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Palliare , Ltd.. Cleared Oct 2020. https://www.510kdatabase.net/k181477/ 2020-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k181477-ms-lide-implant-systems-fda-510k.jpg K181477 - MS Lide Implant Systems K181477 is a FDA 510(k) cleared dental medical device. Manufacturer: Hangzhou Minsheng Lide Medical Science & Technology Co., Ltd.. Cleared Oct 2020. https://www.510kdatabase.net/k193000/ 2020-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k193000-hexanium-acif-fda-510k.jpg K193000 - Hexanium® ACIF K193000 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinevision, S.A.S.. Cleared Oct 2020. https://www.510kdatabase.net/k200794/ 2020-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k200794-accelfix-spinal-fixation-system-fda-510k.jpg K200794 - AccelFix Spinal Fixation System K200794 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: L & K Biomed Co., Ltd.. Cleared Oct 2020. https://www.510kdatabase.net/k201139/ 2020-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k201139-wego-pdo-barbed-suture-fda-510k.jpg K201139 - WEGO-PDO Barbed Suture K201139 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Foosin Medical Supplies Inc., Ltd.. Cleared Oct 2020. https://www.510kdatabase.net/k202393/ 2020-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k202393-spinejack-expansion-kit-fda-510k.jpg K202393 - SpineJack Expansion Kit K202393 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Corporation. Cleared Oct 2020. https://www.510kdatabase.net/k202756/ 2020-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k202756-clariti-1-day-somofilcon-a-clariti-1-fda-510k.jpg K202756 - Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day Multifocal (somofilcon A), Clariti 1 Day Multifocal Toric (somofilcon A) K202756 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: CooperVision, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k200084/ 2020-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k200084-zavation-ibf-system-fda-510k.jpg K200084 - Zavation IBF System K200084 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zavation Medical Products, LLC. Cleared Oct 2020. https://www.510kdatabase.net/k200237/ 2020-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k200237-transcutaneous-electronic-nerve-fda-510k.jpg K200237 - Transcutaneous Electronic Nerve Stimulator K200237 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Kentro Medical Electronics Co., Ltd.. Cleared Oct 2020. https://www.510kdatabase.net/k200821/ 2020-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k200821-anti-bacterial-bandage-fda-510k.jpg K200821 - anti-bacterial bandage K200821 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Planet (Suzhou) Medical Products Co., Ltd.. Cleared Oct 2020. https://www.510kdatabase.net/k201572/ 2020-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k201572-tapestry-biointegrative-implant-fda-510k.jpg K201572 - TAPESTRY Biointegrative Implant K201572 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Embody, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k201771/ 2020-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k201771-single-use-rotatable-and-fda-510k.jpg K201771 - Single Use Rotatable and Repositionable Hemoclip K201771 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Anrei Medical (Hangzhou) Co., Ltd.. Cleared Oct 2020. https://www.510kdatabase.net/k202100/ 2020-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k202100-neocis-guidance-system-ngs-with-fda-510k.jpg K202100 - Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS) K202100 is a FDA 510(k) cleared dental medical device. Manufacturer: Neocis, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k202374/ 2020-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k202374-4mp8mp-color-lcd-monitors-c44wc82w-fda-510k.jpg K202374 - 4MP/8MP Color LCD Monitors C44W+/C82W+, C83W+, C85W+ K202374 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Beacon Display Technology Co., Ltd.. Cleared Oct 2020. https://www.510kdatabase.net/k202771/ 2020-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k202771-cd-horizon-spinal-system-fda-510k.jpg K202771 - CD Horizon Spinal System K202771 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic. Cleared Oct 2020. https://www.510kdatabase.net/k193474/ 2020-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k193474-selectra-3d-outer-guiding-catheters-fda-510k.jpg K193474 - Selectra 3D Outer Guiding Catheters K193474 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biotronik, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k200045/ 2020-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k200045-mutars-cemented-femoral-stems-fda-510k.jpg K200045 - MUTARS Cemented Femoral Stems K200045 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Implantcast GmbH. Cleared Oct 2020. https://www.510kdatabase.net/k200408/ 2020-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k200408-vitavitro-fertilization-medium-fda-510k.jpg K200408 - VitaVitro® Fertilization Medium, VitaVitro® Gamete Buffer Medium, VitaVitro® Flushing Buffer Medium K200408 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shenzhen Vitavitro Biotech Co., Ltd.. Cleared Oct 2020. https://www.510kdatabase.net/k200595/ 2020-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k200595-cellavision-dc-1-cellavision-dc-1-ppa-fda-510k.jpg K200595 - CellaVision DC-1, CellaVision DC-1 PPA K200595 is a FDA 510(k) cleared hematology medical device. Manufacturer: CellaVision AB. Cleared Oct 2020. https://www.510kdatabase.net/k200906/ 2020-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k200906-minicone-implant-fda-510k.jpg K200906 - MINICONE Implant K200906 is a FDA 510(k) cleared dental medical device. Manufacturer: Medentika GmbH. Cleared Oct 2020. https://www.510kdatabase.net/k201129/ 2020-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k201129-medline-smoke-evacuation-pencil-fda-510k.jpg K201129 - Medline Smoke Evacuation Pencil K201129 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medline Industires, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k201396/ 2020-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k201396-finetest-lite-smart-blood-glucose-fda-510k.jpg K201396 - Finetest Lite Smart Blood Glucose Monitoring System K201396 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Osang Healthcare Co. , Ltd.. Cleared Oct 2020. https://www.510kdatabase.net/k201535/ 2020-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k201535-cerament-bone-void-filler-fda-510k.jpg K201535 - Cerament Bone Void Filler K201535 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Bonesupport AB. Cleared Oct 2020. https://www.510kdatabase.net/k201710/ 2020-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k201710-a-view-lcs-fda-510k.jpg K201710 - A View LCS K201710 is a FDA 510(k) cleared radiology medical device. Manufacturer: Coreline Soft Co., Ltd.. Cleared Oct 2020. https://www.510kdatabase.net/k201803/ 2020-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k201803-ossiofiber-hammertoe-fixation-fda-510k.jpg K201803 - OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant K201803 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OSSIO , Ltd.. Cleared Oct 2020. https://www.510kdatabase.net/k201816/ 2020-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k201816-arthrotap-fda-510k.jpg K201816 - ARTHROTAP K201816 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Accuro Technologies, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k202010/ 2020-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k202010-disposable-vinyl-glove-fda-510k.jpg K202010 - Disposable Vinyl Glove K202010 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Better Health Medical Products Co., Ltd.. Cleared Oct 2020. https://www.510kdatabase.net/k202016/ 2020-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k202016-dall-miles-cable-system-fda-510k.jpg K202016 - Dall-Miles® Cable System K202016 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp., Dba Stryker Orthopaedics. Cleared Oct 2020. https://www.510kdatabase.net/k202193/ 2020-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k202193-pullup-btb-adjustable-fixation-system-fda-510k.jpg K202193 - PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP Adjustable Fixation System for Ligament Reconstruction, PULLUP TEX CLIP Adjustable Fixation System for Ligament Reconstruction, BT LOOP Adjustable Fixation System for Ligament Reconstruction K202193 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: S.B.M. Sas (Science & Bio Materials). Cleared Oct 2020. https://www.510kdatabase.net/k202733/ 2020-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k202733-quantum-ventilation-module-fda-510k.jpg K202733 - Quantum Ventilation Module K202733 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Spectrum Medical , Ltd.. Cleared Oct 2020. https://www.510kdatabase.net/k202737/ 2020-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k202737-aplio-i900i800i700i600-diagnostic-fda-510k.jpg K202737 - Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, Aplio a550, Aplio a450, and Aplio a, Diagnostic Ultrasound System, Xario200G and Xario100G, Diagnostic Ultrasound System K202737 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Oct 2020. https://www.510kdatabase.net/k200207/ 2020-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k200207-xport-s-lens-fragmentation-system-fda-510k.jpg K200207 - xPORT S Lens Fragmentation System K200207 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Carl Zeiss Meditec Cataract Technology, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k200296/ 2020-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k200296-pegavision-etafilcon-a-color-daily-fda-510k.jpg K200296 - Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses, Pegavision (Etafilcon A) Color Soft (Hydrophilic) Contact Lenses K200296 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Pegavision Corporation. Cleared Oct 2020. https://www.510kdatabase.net/k200718/ 2020-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k200718-arthrosurface-wristmotion-total-wrist-fda-510k.jpg K200718 - Arthrosurface WristMotion Total Wrist Arthroplasty System K200718 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrosurface, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k200757/ 2020-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k200757-foley-catheter-with-temperature-sensor-fda-510k.jpg K200757 - Foley Catheter with Temperature Sensor K200757 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Deroyal Industries, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k200764/ 2020-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k200764-statstix-fda-510k.jpg K200764 - STATSTIX K200764 is a FDA 510(k) cleared dental medical device. Manufacturer: Centrix Incorporated. Cleared Oct 2020. https://www.510kdatabase.net/k201398/ 2020-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k201398-sinusprime-dilation-system-fda-510k.jpg K201398 - SINUSPRIME Dilation System K201398 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Stryker Ent. Cleared Oct 2020. https://www.510kdatabase.net/k201587/ 2020-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k201587-icotec-anterior-cervical-plate-system-fda-510k.jpg K201587 - icotec Anterior Cervical Plate System K201587 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Icotec AG. Cleared Oct 2020. https://www.510kdatabase.net/k201615/ 2020-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k201615-signa-70t-fda-510k.jpg K201615 - SIGNA 7.0T K201615 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems, LLC. Cleared Oct 2020. https://www.510kdatabase.net/k201908/ 2020-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k201908-liaison-testosterone-xt-fda-510k.jpg K201908 - LIAISON Testosterone xt K201908 is a FDA 510(k) cleared chemistry medical device. Manufacturer: DiaSorin, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k202041/ 2020-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k202041-opera-evo-fda-510k.jpg K202041 - Opera Evo K202041 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Quanta System Spa. Cleared Oct 2020. https://www.510kdatabase.net/k202327/ 2020-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k202327-invictus-osseoscrew-system-fda-510k.jpg K202327 - Invictus™ OsseoScrew® System K202327 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k202340/ 2020-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k202340-droplet-pen-needle-30g-33g-fda-510k.jpg K202340 - Droplet Pen Needle 30G & 33G K202340 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Htl-Strefa S.A. Cleared Oct 2020. https://www.510kdatabase.net/k202349/ 2020-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k202349-cartesion-prime-pcd-1000a-v107-fda-510k.jpg K202349 - Cartesion Prime, PCD-1000A, V10.7 K202349 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Oct 2020. https://www.510kdatabase.net/k202364/ 2020-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k202364-aplio-a550-aplio-a450-aplio-a-fda-510k.jpg K202364 - Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1 K202364 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Oct 2020. https://www.510kdatabase.net/k202665/ 2020-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k202665-echelon-flex-45mm-powered-plus-fda-510k.jpg K202665 - Echelon Flex 45mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Flex 60mm Powered Plus Articulating Endoscopic Linear cutters, Echelon Endopath Endoscopic Linear Cutter Reloads, 45mm, Echelon Endopath Endoscopic Linear Cutter Reloads, 60mm K202665 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon Endo-Surgery, LLC. Cleared Oct 2020. https://www.510kdatabase.net/k202680/ 2020-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k202680-osteomed-extremifix-mini-small-fda-510k.jpg K202680 - OsteoMed ExtremiFix Mini & Small Cannulated Screw System K202680 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteomed, LLC. Cleared Oct 2020. https://www.510kdatabase.net/k202683/ 2020-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k202683-acuson-sequoia-diagnostic-ultrasound-fda-510k.jpg K202683 - ACUSON Sequoia Diagnostic Ultrasound System, ACUSON SC2000 Diagnostic Ultrasound System, ACUSON Freestyle Diagnostic Ultrasound System,ACUSON S1000, S2000, S3000 Diagnostic Ultrasound Systems, ACUSON P200 Diagnostic Ultrasound System, ACUSON P500 Diagnostic Ultrasound System, ACUSON NX3, NX3 Elite Diagnostic Ultrasound System K202683 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k200386/ 2020-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k200386-z5-bl-fda-510k.jpg K200386 - Z5-BL K200386 is a FDA 510(k) cleared dental medical device. Manufacturer: Z-Systems AG. Cleared Oct 2020. https://www.510kdatabase.net/k201562/ 2020-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k201562-spirotrac-fda-510k.jpg K201562 - Spirotrac K201562 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Vitalograph (Ireland) , Ltd.. Cleared Oct 2020. https://www.510kdatabase.net/k201595/ 2020-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k201595-merit-hydrophilic-guide-wire-fda-510k.jpg K201595 - Merit Hydrophilic Guide Wire K201595 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k202666/ 2020-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k202666-construx-mini-ptc-spacer-system-fda-510k.jpg K202666 - CONSTRUX Mini PTC Spacer System K202666 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthofix, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k200114/ 2020-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k200114-astroglide-organix-liquid-fda-510k.jpg K200114 - Astroglide Organix Liquid K200114 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Biofilm, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k200596/ 2020-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k200596-g21-cement-vader-pedicle-system-fda-510k.jpg K200596 - G21 Cement, VADER® Pedicle System K200596 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Icotec AG. Cleared Oct 2020. https://www.510kdatabase.net/k201962/ 2020-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k201962-skeletal-dynamics-ulnar-shortening-fda-510k.jpg K201962 - Skeletal Dynamics Ulnar Shortening Plating System K201962 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Skeletal Dynamics, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k202305/ 2020-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k202305-zavation-ibf-system-fda-510k.jpg K202305 - Zavation IBF System K202305 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zavation Medical Products, LLC. Cleared Oct 2020. https://www.510kdatabase.net/k200633/ 2020-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k200633-halyard-black-fire-powder-free-nitrile-fda-510k.jpg K200633 - Halyard Black-Fire Powder-Free Nitrile Exam Glove, Halyard Purple Powder-Free Nitrile Exam Glove K200633 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 0 & M Halyard, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k201528/ 2020-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k201528-yushan-x-ray-flat-panel-detector-with-fda-510k.jpg K201528 - Yushan X-Ray Flat Panel Detector with DROC K201528 is a FDA 510(k) cleared radiology medical device. Manufacturer: Innocare Optoelectronics Corp.. Cleared Oct 2020. https://www.510kdatabase.net/k201828/ 2020-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k201828-voluson-swift-voluson-swift-fda-510k.jpg K201828 - Voluson SWIFT, Voluson SWIFT+ K201828 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared Oct 2020. https://www.510kdatabase.net/k202213/ 2020-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k202213-syngoct-neuro-perfusion-fda-510k.jpg K202213 - syngo.CT Neuro Perfusion K202213 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k202501/ 2020-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k202501-quantib-prostate-fda-510k.jpg K202501 - Quantib Prostate K202501 is a FDA 510(k) cleared radiology medical device. Manufacturer: Quantib B.V.. Cleared Oct 2020. https://www.510kdatabase.net/k192921/ 2020-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k192921-zeos-aqua-vision-pump-and-tube-fda-510k.jpg K192921 - Zeos Aqua Vision Pump and tube K192921 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Hemodia Sas. Cleared Oct 2020. https://www.510kdatabase.net/k193631/ 2020-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k193631-stethee-pro-1-stethee-pro-software-fda-510k.jpg K193631 - Stethee Pro 1, Stethee Pro Software System K193631 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: M3Dicine Pty , Ltd.. Cleared Oct 2020. https://www.510kdatabase.net/k200103/ 2020-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k200103-bioteq-drainage-catheter-set-one-step-fda-510k.jpg K200103 - BIOTEQ Drainage Catheter Set (One Step Type) K200103 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Bioteque Corporation. Cleared Oct 2020. https://www.510kdatabase.net/k200434/ 2020-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k200434-v20-v20a-avsm3-snf-fda-510k.jpg K200434 - V20, V20a, AVSM3 SNF K200434 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Mediana Co., Ltd.. Cleared Oct 2020. https://www.510kdatabase.net/k200510/ 2020-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k200510-multi-linktm-x2-ecg-adapter-and-fda-510k.jpg K200510 - Multi-LinkTM X2 ECG Adapter and Leadwires K200510 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vyaire Medical, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k201038/ 2020-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k201038-luce-ceramic-bracket-fda-510k.jpg K201038 - Luce Ceramic Bracket K201038 is a FDA 510(k) cleared dental medical device. Manufacturer: Luce Castle Co., Ltd.. Cleared Oct 2020. https://www.510kdatabase.net/k201377/ 2020-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k201377-saberx-radianz-percutaneous-fda-510k.jpg K201377 - SABERX RADIANZ Percutaneous Transluminal Angioplasty Dilatation Catheter K201377 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corporation. Cleared Oct 2020. https://www.510kdatabase.net/k201882/ 2020-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k201882-aeon-endoscopic-stapler-fda-510k.jpg K201882 - AEON Endoscopic Stapler K201882 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lexington Medical, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k201983/ 2020-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k201983-bci-602-lifts-1-mm-bci-lifts-1-mm-bci-fda-510k.jpg K201983 - BCI 602 Lifts (1 mm), BCI Lifts (1 mm), BCI Lifts (2 mm & 3 mm), BCI Lifts (4 mm) K201983 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Med-El Elektromedizinische Geraete GmbH. Cleared Oct 2020. https://www.510kdatabase.net/k202285/ 2020-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k202285-medline-enfit-otc-feeding-syringe-fda-510k.jpg K202285 - Medline ENfit OTC Feeding Syringe K202285 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medline Industries, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k202609/ 2020-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k202609-instrument-clamps-electromagnetic-fda-510k.jpg K202609 - Instrument Clamps Electromagnetic K202609 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Stryker Corporation. Cleared Oct 2020. https://www.510kdatabase.net/k202740/ 2020-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k202740-klassic-knee-system-tibial-inserts-ps-fda-510k.jpg K202740 - Klassic Knee System Tibial Inserts, PS-Max K202740 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Total Joint Orthopedics, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k192703/ 2020-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k192703-cranial-image-guided-surgery-system-fda-510k.jpg K192703 - Cranial Image Guided Surgery System, Navigation Software Cranial, Navigation Software ENT, Registration Software Cranial, Automatic Registration 2.0, Ultrasound Navigation Software (BK), Intraoperative Structure Update K192703 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Oct 2020. https://www.510kdatabase.net/k193542/ 2020-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k193542-clearum-hs-family-clearum-hs-models-hs-fda-510k.jpg K193542 - Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22 K193542 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Bellco Srl. Cleared Oct 2020. https://www.510kdatabase.net/k200661/ 2020-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k200661-steripath-micro-blood-collection-system-fda-510k.jpg K200661 - Steripath Micro Blood Collection System K200661 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Magnolia Medical Technologies, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k200767/ 2020-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k200767-silverstream-gel-fda-510k.jpg K200767 - SilverStream Gel K200767 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Enzysurge , Ltd.. Cleared Oct 2020. https://www.510kdatabase.net/k200793/ 2020-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k200793-lnk-posterior-cervical-fixation-system-fda-510k.jpg K200793 - LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System K200793 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: L & K Biomed Co., Ltd.. Cleared Oct 2020. https://www.510kdatabase.net/k200810/ 2020-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k200810-ips-casedesigner-fda-510k.jpg K200810 - IPS CaseDesigner K200810 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nobel Biocare AB. Cleared Oct 2020. https://www.510kdatabase.net/k201483/ 2020-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k201483-impression-material-fda-510k.jpg K201483 - Impression Material K201483 is a FDA 510(k) cleared dental medical device. Manufacturer: Zhengzhou Huaer Electro Optics Technology Co., Ltd.. Cleared Oct 2020. https://www.510kdatabase.net/k201525/ 2020-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k201525-ecg-app-fda-510k.jpg K201525 - ECG App K201525 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Apple, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k201777/ 2020-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k201777-31hn713d-fda-510k.jpg K201777 - 31HN713D K201777 is a FDA 510(k) cleared radiology medical device. Manufacturer: Lg Electronics.Inc. Cleared Oct 2020. https://www.510kdatabase.net/k201845/ 2020-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k201845-portable-electro-stimulation-therapy-fda-510k.jpg K201845 - Portable Electro-Stimulation Therapy Device, Model: LGT-232(US) K201845 is a FDA 510(k) cleared neurology medical device. Manufacturer: Guangzhou Longest Science & Technology Co., Ltd.. Cleared Oct 2020. https://www.510kdatabase.net/k201917/ 2020-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k201917-piccolo-composite-proximal-tibia-plate-fda-510k.jpg K201917 - Piccolo Composite Proximal Tibia Plate System K201917 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: CarboFix Orthopedics , Ltd.. Cleared Oct 2020. https://www.510kdatabase.net/k201939/ 2020-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k201939-gaia-lumbar-interbody-fusion-device-fda-510k.jpg K201939 - GAIA Lumbar Interbody Fusion Device (LIFD) Family K201939 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Printerprezz. Cleared Oct 2020. https://www.510kdatabase.net/k201970/ 2020-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k201970-schoelly-cystoscopeshysteroscopes-and-fda-510k.jpg K201970 - Schoelly Cystoscopes/Hysteroscopes and Accessories K201970 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Schoelly Fiberoptic GmbH. Cleared Oct 2020. https://www.510kdatabase.net/k201972/ 2020-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k201972-aplio-i900i800i700-diagnostic-fda-510k.jpg K201972 - Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V5.1 K201972 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Oct 2020. https://www.510kdatabase.net/k202309/ 2020-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k202309-epic-anterior-thoracolumbar-plate-fda-510k.jpg K202309 - Epic Anterior Thoracolumbar Plate System, Gallery Laminoplasty Fixation System, Concero Facet Screw System, Alpine XC Adjustable Fusion System, Aspen MIS Fusion System, L-Plate MIS Fusion System K202309 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer Biomet Spine, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k202478/ 2020-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k202478-captivator-single-use-polypectomy-fda-510k.jpg K202478 - Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares K202478 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Oct 2020. https://www.510kdatabase.net/k202592/ 2020-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k202592-adavanced-imaging-modality-system-1688-fda-510k.jpg K202592 - Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging Modality, L11 LED Light Source with Adavanced Imaging Modality) K202592 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker. Cleared Oct 2020. https://www.510kdatabase.net/k192949/ 2020-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k192949-flower-suture-anchor-set-fda-510k.jpg K192949 - Flower Suture Anchor Set K192949 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Flower Orthopedics Corporation. Cleared Oct 2020. https://www.510kdatabase.net/k200100/ 2020-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k200100-abutment-design-fda-510k.jpg K200100 - Abutment Design K200100 is a FDA 510(k) cleared dental medical device. Manufacturer: 3Shape A/S. Cleared Oct 2020. https://www.510kdatabase.net/k200725/ 2020-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k200725-citregen-tendon-interference-screw-and-fda-510k.jpg K200725 - Citregen Tendon Interference Screw and Citrelock K200725 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Acuitive Technologies. Cleared Oct 2020. https://www.510kdatabase.net/k200802/ 2020-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k200802-infrared-thermometer-fda-510k.jpg K200802 - Infrared Thermometer K200802 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen Urion Technology Co., Ltd.. Cleared Oct 2020. https://www.510kdatabase.net/k200817/ 2020-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k200817-uris-omni-narrow-system-prosthetic-fda-510k.jpg K200817 - URIS OMNI Narrow System & Prosthetic K200817 is a FDA 510(k) cleared dental medical device. Manufacturer: Truabutment, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k201380/ 2020-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k201380-livocare-surgical-mask-fda-510k.jpg K201380 - Livocare Surgical Mask K201380 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Andon Health Co, Ltd.. Cleared Oct 2020. https://www.510kdatabase.net/k201453/ 2020-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k201453-fortilink-cages-with-tiplus-technology-fda-510k.jpg K201453 - Fortilink Cages with TiPlus Technology K201453 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paradigm Spine GmbH. Cleared Oct 2020. https://www.510kdatabase.net/k202119/ 2020-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k202119-acusee-as-p1000-system-fda-510k.jpg K202119 - AcuSee AS-P1000 System K202119 is a FDA 510(k) cleared radiology medical device. Manufacturer: Weipeng (Suzhou) Medical Devices Co., Ltd.. Cleared Oct 2020. https://www.510kdatabase.net/k202293/ 2020-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k202293-radiographic-system-challenge-x-fda-510k.jpg K202293 - Radiographic System Challenge X K202293 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sedecal., Sa.. Cleared Oct 2020. https://www.510kdatabase.net/k202633/ 2020-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k202633-scanx-edge-fda-510k.jpg K202633 - ScanX Edge K202633 is a FDA 510(k) cleared radiology medical device. Manufacturer: D?rr Dental SE. Cleared Oct 2020. https://www.510kdatabase.net/k200728/ 2020-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k200728-pitkar-deftfix-system-fda-510k.jpg K200728 - Pitkar DeftFix System K200728 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: S.H.Pitkar Orthotools Pvt. , Ltd.. Cleared Oct 2020. https://www.510kdatabase.net/k200953/ 2020-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k200953-nuvasive-cohere-thoracolumbar-fda-510k.jpg K200953 - NuVasive® Cohere® Thoracolumbar Interbody System K200953 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Oct 2020. https://www.510kdatabase.net/k201701/ 2020-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k201701-r3-ha-coated-acetabular-shells-fda-510k.jpg K201701 - R3 HA Coated Acetabular Shells K201701 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k202114/ 2020-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k202114-coolseal-generatorcsl-200-50-coolseal-fda-510k.jpg K202114 - CoolSeal Generator/CSL-200-50, CoolSeal Trinity (30 cm shaft)/CSL-TR105-30, CoolSeal Trinity (37 cm shaft)/CSL-TR105-37, CoolSeal Trinity (44 cm shaft)/CSL-TR105-44, CoolSeal Mini (20cm shaft)/CSL-MN103-20 K202114 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bolder Surgical, LLC. Cleared Oct 2020. https://www.510kdatabase.net/k202253/ 2020-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k202253-truform-sievers-annuloplasty-ring-fda-510k.jpg K202253 - TruForm Sievers Annuloplasty Ring K202253 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Genesee Biomedical, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k202584/ 2020-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k202584-isleeve-introducer-set-fda-510k.jpg K202584 - iSleeve Introducer Set K202584 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Oct 2020. https://www.510kdatabase.net/k200031/ 2020-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k200031-neonatal-phototherapy-system-fda-510k.jpg K200031 - Neonatal Phototherapy System K200031 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Avalon Biomedical (Shenzhen) Limited. Cleared Oct 2020. https://www.510kdatabase.net/k200217/ 2020-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k200217-clearendoclip-fda-510k.jpg K200217 - ClearEndoclip K200217 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Finemedix Co., Ltd.. Cleared Oct 2020. https://www.510kdatabase.net/k200792/ 2020-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k200792-myspine-s2-alaralar-iliac-pedicle-fda-510k.jpg K200792 - MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement Guides K200792 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta Inernational SA. Cleared Oct 2020. https://www.510kdatabase.net/k201561/ 2020-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k201561-membrane-screws-and-membrane-tacks-fda-510k.jpg K201561 - Membrane Screws and Membrane Tacks K201561 is a FDA 510(k) cleared dental medical device. Manufacturer: Neoss Limited. Cleared Oct 2020. https://www.510kdatabase.net/k201659/ 2020-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k201659-kheiron-spinal-fixation-system-fda-510k.jpg K201659 - KHEIRON® Spinal Fixation System K201659 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: S.M.A.I.O. Cleared Oct 2020. https://www.510kdatabase.net/k202292/ 2020-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k202292-ude-fda-510k.jpg K202292 - UDE K202292 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ebm Technologies, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k202294/ 2020-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k202294-affirm-contrast-biopsy-fda-510k.jpg K202294 - Affirm Contrast Biopsy K202294 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hologic, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k190707/ 2020-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k190707-arthrex-softstitch-fda-510k.jpg K190707 - Arthrex SoftStitch K190707 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Arthrex, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k191320/ 2020-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k191320-slow-wave-ds8-fda-510k.jpg K191320 - Slow Wave DS8 K191320 is a FDA 510(k) cleared dental medical device. Manufacturer: Slow Wave, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k193410/ 2020-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k193410-sozo-body-fluid-analyzer-fda-510k.jpg K193410 - SOZO Body Fluid Analyzer K193410 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: ImpediMed Limited. Cleared Oct 2020. https://www.510kdatabase.net/k200623/ 2020-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k200623-ossguide-fda-510k.jpg K200623 - OssGuide K200623 is a FDA 510(k) cleared dental medical device. Manufacturer: Sk Bioland Co., Ltd.. Cleared Oct 2020. https://www.510kdatabase.net/k200682/ 2020-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k200682-bzf-29-fda-510k.jpg K200682 - BZF-29 K200682 is a FDA 510(k) cleared dental medical device. Manufacturer: GC America, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k201161/ 2020-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k201161-infrared-thermometer-model-e127-fda-510k.jpg K201161 - Infrared Thermometer Model E127 K201161 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bioland Technology, Ltd.. Cleared Oct 2020. https://www.510kdatabase.net/k201238/ 2020-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k201238-encore-system-fda-510k.jpg K201238 - Encore System K201238 is a FDA 510(k) cleared dental medical device. Manufacturer: Siesta Medical, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k201301/ 2020-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k201301-x100-with-full-field-peripheral-blood-fda-510k.jpg K201301 - X100 with Full Field Peripheral Blood Smear (PBS) Application K201301 is a FDA 510(k) cleared hematology medical device. Manufacturer: Scopio Labs , Ltd.. Cleared Oct 2020. https://www.510kdatabase.net/k201546/ 2020-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k201546-osopia-synthetic-bone-void-filler-fda-510k.jpg K201546 - OsOpia Synthetic Bone Void Filler K201546 is a FDA 510(k) cleared dental medical device. Manufacturer: Revisios BV. Cleared Oct 2020. https://www.510kdatabase.net/k201559/ 2020-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k201559-hal-for-medical-uselower-limb-type-fda-510k.jpg K201559 - HAL for Medical Use(Lower Limb type) K201559 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cyberdyne, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k201748/ 2020-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k201748-latex-powder-free-surgical-glove-with-fda-510k.jpg K201748 - Latex Powder Free Surgical Glove with Protein Labelling Claim of 50 Microgram or Less per Gram of Glove and Tested for use with Chemotherapy Drugs K201748 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hartalega Sdn Bhd. Cleared Oct 2020. https://www.510kdatabase.net/k202170/ 2020-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k202170-livermultiscan-fda-510k.jpg K202170 - LiverMultiScan K202170 is a FDA 510(k) cleared radiology medical device. Manufacturer: Perspectum, Ltd.. Cleared Oct 2020. https://www.510kdatabase.net/k202190/ 2020-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k202190-oculus-sa-lumbar-cage-system-fda-510k.jpg K202190 - Oculus-SA Lumbar Cage System K202190 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Neurostructures. Cleared Oct 2020. https://www.510kdatabase.net/k202207/ 2020-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k202207-materialise-pka-guide-system-fda-510k.jpg K202207 - Materialise PKA Guide System K202207 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Materialise NV. Cleared Oct 2020. https://www.510kdatabase.net/k202218/ 2020-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k202218-zelantedvt-thrombectomy-system-fda-510k.jpg K202218 - ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device K202218 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Oct 2020. https://www.510kdatabase.net/k202280/ 2020-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k202280-cleerly-labs-v20-fda-510k.jpg K202280 - Cleerly Labs v2.0 K202280 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cleerly, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k202557/ 2020-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k202557-quantum-workstation-12-elite-fda-510k.jpg K202557 - Quantum Workstation 12 Elite K202557 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Spectrum Medical , Ltd.. Cleared Oct 2020. https://www.510kdatabase.net/k200067/ 2020-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k200067-mectascope-system-fda-510k.jpg K200067 - MectaScope System K200067 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Oct 2020. https://www.510kdatabase.net/k200127/ 2020-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k200127-telegraph-evolution-humeral-nailing-fda-510k.jpg K200127 - TELEGRAPH® EVOLUTION Humeral Nailing System K200127 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: FH Industrie. Cleared Oct 2020. https://www.510kdatabase.net/k200544/ 2020-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k200544-smartlyte-plus-electrolyte-analyzer-fda-510k.jpg K200544 - SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+ K200544 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diamond Diagnostics, Inc.. Cleared Oct 2020. https://www.510kdatabase.net/k200710/ 2020-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k200710-infrared-pt2l-digital-no-touch-fda-510k.jpg K200710 - Infrared PT2L Digital No-Touch Thermometer K200710 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Andon Health Co, Ltd.. Cleared Oct 2020. https://www.510kdatabase.net/k201359/ 2020-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k201359-ecg-cables-and-leadwires-fda-510k.jpg K201359 - ECG Cables and Leadwires K201359 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Xinkang Medical Instrument Co. , Ltd.. Cleared Oct 2020. https://www.510kdatabase.net/k201381/ 2020-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k201381-philips-avent-singledouble-electric-fda-510k.jpg K201381 - Philips Avent Single/Double electric breast pump Advanced K201381 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Philips Consumer Lifestyle - Innovation Site Eindhoven. Cleared Oct 2020. https://www.510kdatabase.net/k201446/ 2020-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k201446-hemosphere-advanced-monitoring-fda-510k.jpg K201446 - HemoSphere Advanced Monitoring Platform, HemoSphere ClearSight Module K201446 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesiences, LLC. Cleared Oct 2020. https://www.510kdatabase.net/k202357/ 2020-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k202357-nutricare-clear-isosaf-nasogastric-fda-510k.jpg K202357 - Nutricare Clear-ISOSAF Nasogastric Feeding Tube K202357 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Three Circles Consulting Limited. Cleared Oct 2020. https://www.510kdatabase.net/k192051/ 2020-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k192051-thinq-fda-510k.jpg K192051 - THINQ K192051 is a FDA 510(k) cleared radiology medical device. Manufacturer: Corticometrics, LLC. Cleared Sep 2020. https://www.510kdatabase.net/k192077/ 2020-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k192077-tua-face-fitness-tua-trend-face-fda-510k.jpg K192077 - Tua Face Fitness / Tua Trend Face K192077 is a FDA 510(k) cleared neurology medical device. Manufacturer: Vupiesse S.R.L. Cleared Sep 2020. https://www.510kdatabase.net/k200475/ 2020-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k200475-ids-isys-ostase-bap-fda-510k.jpg K200475 - IDS-iSYS Ostase BAP K200475 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Immunodiagnostic Systems , Ltd.. Cleared Sep 2020. https://www.510kdatabase.net/k201188/ 2020-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k201188-clear-guide-scenergy-fda-510k.jpg K201188 - Clear Guide SCENERGY K201188 is a FDA 510(k) cleared radiology medical device. Manufacturer: Clear Guide Medical. Cleared Sep 2020. https://www.510kdatabase.net/k201928/ 2020-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k201928-e-ortho-shoulder-software-fda-510k.jpg K201928 - e-Ortho Shoulder Software K201928 is a FDA 510(k) cleared radiology medical device. Manufacturer: FH Industrie. Cleared Sep 2020. https://www.510kdatabase.net/k202376/ 2020-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k202376-everlift-submucosal-lifting-agent-fda-510k.jpg K202376 - EverLift Submucosal Lifting Agent K202376 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Gi Supply, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k202542/ 2020-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k202542-allura-vaginal-stent-fda-510k.jpg K202542 - Allura Vaginal Stent K202542 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Pmt Corporation. Cleared Sep 2020. https://www.510kdatabase.net/k202564/ 2020-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k202564-digitaldiagnost-c90-fda-510k.jpg K202564 - DigitalDiagnost C90 K202564 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Dmc GmbH. Cleared Sep 2020. https://www.510kdatabase.net/k202566/ 2020-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k202566-wiygul-catheter-fda-510k.jpg K202566 - Wiygul Catheter K202566 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Big Blue Biotech, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k191738/ 2020-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k191738-pagewriter-tc20-cardiograph-pagewriter-fda-510k.jpg K191738 - PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph, PageWriter TC70 Cardiograph K191738 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Philips Medical Systems. Cleared Sep 2020. https://www.510kdatabase.net/k193131/ 2020-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k193131-bd-quincke-spinal-nrfit-needle-bd-fda-510k.jpg K193131 - BD Quincke Spinal NRFit Needle, BD Whitacre Spinal NRFit Needle, BD Spinal Introducer NRFit Needle K193131 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Becton, Dickinson and Company. Cleared Sep 2020. https://www.510kdatabase.net/k193401/ 2020-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k193401-altatec-gmbh-camlogconelog-progressive-fda-510k.jpg K193401 - Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE Implants K193401 is a FDA 510(k) cleared dental medical device. Manufacturer: Altatec GmbH. Cleared Sep 2020. https://www.510kdatabase.net/k201790/ 2020-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k201790-dual-cure-resin-cement-fda-510k.jpg K201790 - Dual Cure Resin Cement K201790 is a FDA 510(k) cleared dental medical device. Manufacturer: Rizhao Huge Biomaterials Company, Ltd.. Cleared Sep 2020. https://www.510kdatabase.net/k201819/ 2020-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k201819-cadwell-apollo-system-fda-510k.jpg K201819 - Cadwell Apollo System K201819 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cadwell Industries, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k201895/ 2020-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k201895-cefaly-dual-fda-510k.jpg K201895 - Cefaly Dual K201895 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cefaly Technology. Cleared Sep 2020. https://www.510kdatabase.net/k202546/ 2020-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k202546-lvivo-seamless-fda-510k.jpg K202546 - LVivo Seamless K202546 is a FDA 510(k) cleared radiology medical device. Manufacturer: Dia Imaging Analysis, Ltd.. Cleared Sep 2020. https://www.510kdatabase.net/k192717/ 2020-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k192717-da-vinci-sp-surgical-system-fda-510k.jpg K192717 - da Vinci SP Surgical System K192717 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k193299/ 2020-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k193299-vitek-2-ast-gram-negative-ceftazidime-fda-510k.jpg K193299 - VITEK 2 AST-Gram Negative Ceftazidime (=<0.5 - =>32 µg/mL) K193299 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k200557/ 2020-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k200557-enteral-feeding-syringes-with-enfit-fda-510k.jpg K200557 - Enteral Feeding Syringes with ENfit connector (Model: 10 ml K200557 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Jiangsu Shenli Medical Production Co., Ltd.. Cleared Sep 2020. https://www.510kdatabase.net/k201221/ 2020-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k201221-electrosurgical-generator-fda-510k.jpg K201221 - Electrosurgical Generator K201221 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: New Deantronics Taiwan , Ltd.. Cleared Sep 2020. https://www.510kdatabase.net/k201682/ 2020-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k201682-rist-radial-access-catheter-fda-510k.jpg K201682 - RIST Radial Access Catheter K201682 is a FDA 510(k) cleared neurology medical device. Manufacturer: Rist Neurovascular, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k201795/ 2020-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k201795-transcend-fda-510k.jpg K201795 - Transcend K201795 is a FDA 510(k) cleared dental medical device. Manufacturer: Ultradent Product, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k201814/ 2020-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k201814-bd-facslyric-flow-cytometer-3-1-4-2-4-fda-510k.jpg K201814 - BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2, 4-3-3 and 4-3-5 optical configurations), BD FACSDuet Sample Preparation System, BD FACS Universal Loader, BD FACSuite Clinical software, BD Multitest 6-Color Assay Modules, BD Multitest 4-Color Assay Modules, BD FACSFlow Sheath Fluid, BD CS&T Beads, BD FC Beads 7-Color Kit K201814 is a FDA 510(k) cleared immunology medical device. Manufacturer: Becton, Dickinson and Company. Cleared Sep 2020. https://www.510kdatabase.net/k202543/ 2020-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k202543-omniwire-pressure-guide-wire-185-cm-fda-510k.jpg K202543 - OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip K202543 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Volcano Corporation. Cleared Sep 2020. https://www.510kdatabase.net/k202685/ 2020-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k202685-eon-aligner-fda-510k.jpg K202685 - Eon Aligner K202685 is a FDA 510(k) cleared dental medical device. Manufacturer: Eon Dental Jordan, LLC. Cleared Sep 2020. https://www.510kdatabase.net/k182906/ 2020-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k182906-portable-mesh-nebulizer-fda-510k.jpg K182906 - Portable Mesh Nebulizer K182906 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Feellife Health, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k191982/ 2020-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k191982-low-frequency-multi-function-fda-510k.jpg K191982 - Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212) K191982 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Kentro Medical Electronics Co., Ltd.. Cleared Sep 2020. https://www.510kdatabase.net/k193546/ 2020-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k193546-distal-centralizers-fda-510k.jpg K193546 - Distal Centralizers K193546 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k193583/ 2020-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k193583-restrata-fda-510k.jpg K193583 - Restrata® K193583 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Acera Surgical, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k200051/ 2020-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k200051-puggle-enteral-feeding-pump-and-fda-510k.jpg K200051 - PUGGLE Enteral Feeding Pump and Feeding Set K200051 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Amsino International, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k200076/ 2020-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k200076-breezing-med-fda-510k.jpg K200076 - Breezing Med K200076 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Tf Health Co.. Cleared Sep 2020. https://www.510kdatabase.net/k201103/ 2020-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k201103-xeleris-v-processing-and-review-systems-fda-510k.jpg K201103 - Xeleris V Processing and Review Systems K201103 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Sep 2020. https://www.510kdatabase.net/k201273/ 2020-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k201273-imagespectrum-fda-510k.jpg K201273 - ImageSPECTRUM K201273 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Canon, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k201439/ 2020-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k201439-ventilator-non-continuous-respirator-fda-510k.jpg K201439 - Ventilator, Non-continuous (Respirator) K201439 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k201756/ 2020-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k201756-reprocessed-myosure-tissue-removal-fda-510k.jpg K201756 - Reprocessed MyoSure Tissue Removal Device, Reprocessed MyoSure REACH Tissue Removal Device, Reprocessed MyoSure LITE Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device, Reprocessed MyoSure XL Tissue Removal Device for Fluent K201756 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Stryker Sustainability Solutions. Cleared Sep 2020. https://www.510kdatabase.net/k201787/ 2020-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k201787-light-cure-dental-adhesive-fda-510k.jpg K201787 - Light Cure Dental Adhesive K201787 is a FDA 510(k) cleared dental medical device. Manufacturer: Rizhao Huge Biomaterials Company, Ltd.. Cleared Sep 2020. https://www.510kdatabase.net/k201820/ 2020-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k201820-nuvasive-thoracolumbar-interbody-fda-510k.jpg K201820 - NuVasive Thoracolumbar Interbody Systems: CoRoent Thoracolumbar System, CoRoent XL Interfixated System, Brigade Standalone System and Brigade Hyperlordotic System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, Cohere Thoracolumbar Interbody System, Modulus XLIF Interbody System, Modulus TLIF Interbody System, 3DP Interfixated ALIF System K201820 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Sep 2020. https://www.510kdatabase.net/k202039/ 2020-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k202039-honorst-implant-system-fda-510k.jpg K202039 - Honorst Implant System K202039 is a FDA 510(k) cleared dental medical device. Manufacturer: Medimecca Co., Ltd.. Cleared Sep 2020. https://www.510kdatabase.net/k202277/ 2020-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k202277-surgical-face-mask-fda-510k.jpg K202277 - Surgical Face Mask K202277 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangxi 3l Medical Products Group Co., Ltd.. Cleared Sep 2020. https://www.510kdatabase.net/k202446/ 2020-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k202446-bd-preset-syringe-bd-a-line-syringe-fda-510k.jpg K202446 - BD Preset Syringe & BD A-Line Syringe K202446 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Becton, Dickinson and Company. Cleared Sep 2020. https://www.510kdatabase.net/k202522/ 2020-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k202522-synchro-select-guidewire-fda-510k.jpg K202522 - Synchro SELECT Guidewire K202522 is a FDA 510(k) cleared neurology medical device. Manufacturer: Stryker Neurovascular. Cleared Sep 2020. https://www.510kdatabase.net/k202567/ 2020-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k202567-wondfo-t-dip-multi-drug-urine-test-fda-510k.jpg K202567 - Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel Rx K202567 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.. Cleared Sep 2020. https://www.510kdatabase.net/k200115/ 2020-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k200115-cavetto-sa-cervical-cage-system-fda-510k.jpg K200115 - Cavetto-SA Cervical Cage System K200115 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Neurostructures, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k200569/ 2020-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k200569-raystation-fda-510k.jpg K200569 - RayStation K200569 is a FDA 510(k) cleared radiology medical device. Manufacturer: RaySearch Laboratories AB (PUBL). Cleared Sep 2020. https://www.510kdatabase.net/k201051/ 2020-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k201051-straumann-boneceramic-fda-510k.jpg K201051 - Straumann BoneCeramic K201051 is a FDA 510(k) cleared dental medical device. Manufacturer: Institut Straumann AG. Cleared Sep 2020. https://www.510kdatabase.net/k201260/ 2020-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k201260-dermal-cooling-system-fda-510k.jpg K201260 - Dermal Cooling System K201260 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: R2 Technologies, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k201684/ 2020-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k201684-a-silicone-for-bite-registration-fda-510k.jpg K201684 - A-Silicone for Bite Registration K201684 is a FDA 510(k) cleared dental medical device. Manufacturer: Shandong Huge Dental Material Corporation. Cleared Sep 2020. https://www.510kdatabase.net/k201770/ 2020-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k201770-masimo-rad-g-pulse-oximeter-masimo-rad-fda-510k.jpg K201770 - Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensor K201770 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Masimo Corporation. Cleared Sep 2020. https://www.510kdatabase.net/k202477/ 2020-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k202477-endogi-s-path-biliary-stent-system-fda-510k.jpg K202477 - EndoGI S-Path Biliary Stent System K202477 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Endo GI Medical. Cleared Sep 2020. https://www.510kdatabase.net/k202484/ 2020-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k202484-cordera-hip-system-fda-510k.jpg K202484 - Cordera Hip System K202484 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Conformis, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k202572/ 2020-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k202572-gxr-series-diagnostic-x-ray-system-fda-510k.jpg K202572 - GXR-Series Diagnostic X-Ray System K202572 is a FDA 510(k) cleared radiology medical device. Manufacturer: DRGEM Corporation. Cleared Sep 2020. https://www.510kdatabase.net/den200002/ 2020-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/den200002-tangible-boost-fda-510k.jpg DEN200002 - Tangible Boost DEN200002 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Tangible Science, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k193276/ 2020-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k193276-nerve-and-muscle-stimulator-fda-510k.jpg K193276 - Nerve and Muscle Stimulator K193276 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Xft Medical Limited. Cleared Sep 2020. https://www.510kdatabase.net/k200414/ 2020-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k200414-pulse-oximeter-fda-510k.jpg K200414 - Pulse Oximeter K200414 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Aeon Technology Co., Ltd.. Cleared Sep 2020. https://www.510kdatabase.net/k200416/ 2020-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k200416-boston-one-step-liquid-enzymatic-cleaner-fda-510k.jpg K200416 - Boston One Step Liquid Enzymatic Cleaner K200416 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Bausch & Lomb, Incorporated. Cleared Sep 2020. https://www.510kdatabase.net/k201208/ 2020-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k201208-halo-af-detection-system-fda-510k.jpg K201208 - Halo AF Detection System K201208 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Livmor. Cleared Sep 2020. https://www.510kdatabase.net/k201346/ 2020-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k201346-depuy-synthes-retrograde-femoral-nail-fda-510k.jpg K201346 - DePuy Synthes Retrograde Femoral Nail Advanced System, DePuy Synthes Locking Screws for Medullary Nails, 5.0 mm K201346 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes USA Products, LLC. Cleared Sep 2020. https://www.510kdatabase.net/k201367/ 2020-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k201367-flarehawk-tihawk9-interbody-fusion-fda-510k.jpg K201367 - FlareHawk TiHawk9 Interbody Fusion System K201367 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Integrity Implants, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k202479/ 2020-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k202479-ibs-implant-system-fda-510k.jpg K202479 - IBS Implant System K202479 is a FDA 510(k) cleared dental medical device. Manufacturer: Innobiosurg Co., Ltd.. Cleared Sep 2020. https://www.510kdatabase.net/k202569/ 2020-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k202569-responsive-arthroscopy-interference-fda-510k.jpg K202569 - Responsive Arthroscopy Interference Screw System K202569 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Responsive Arthroscopy, LLC. Cleared Sep 2020. https://www.510kdatabase.net/k200123/ 2020-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k200123-accessories-for-the-sixfix-hexapod-fda-510k.jpg K200123 - Accessories for the SixFix® Hexapod Fixator K200123 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arrowhead De, LLC. Cleared Sep 2020. https://www.510kdatabase.net/k200843/ 2020-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k200843-halyard-pink-underguard-zero-sterile-fda-510k.jpg K200843 - Halyard Pink Underguard Zero, Sterile Powder-Free Exam Gloves Tested with Chemotherapy Drugs K200843 is a FDA 510(k) cleared general hospital medical device. Manufacturer: O&M Halyard, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k200987/ 2020-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k200987-ltj-screws-and-washer-fda-510k.jpg K200987 - LTJ Screws and Washer K200987 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Azurmeds, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k201717/ 2020-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k201717-bd-cathena-safety-iv-catheter-fda-510k.jpg K201717 - BD Cathena Safety IV Catheter K201717 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton Dickinson Infusion Therapy Systems, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k202210/ 2020-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k202210-vantage-orian-15t-mrt-1550-v60-fda-510k.jpg K202210 - Vantage Orian 1.5T, MRT-1550, V6.0 K202210 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Sep 2020. https://www.510kdatabase.net/k202448/ 2020-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k202448-dailies-aquacomfort-plus-dacp-dacp-fda-510k.jpg K202448 - DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal K202448 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Alcon Laboratories, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k192707/ 2020-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k192707-optiflux-f180nr-dialyzer-fda-510k.jpg K192707 - Optiflux F180NR Dialyzer K192707 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC. Cleared Sep 2020. https://www.510kdatabase.net/k192814/ 2020-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k192814-pounce-thrombus-retrieval-system-fda-510k.jpg K192814 - Pounce Thrombus Retrieval System K192814 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Surmodics,Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k201278/ 2020-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k201278-world-hip-stem-world-cup-world-liner-fda-510k.jpg K201278 - World Hip Stem, World Cup, World Liner K201278 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Signature Orthopaedics Pty, Ltd.. Cleared Sep 2020. https://www.510kdatabase.net/k201290/ 2020-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k201290-medline-denovo-4pro-electrical-fda-510k.jpg K201290 - Medline DeNovo 4Pro Electrical Stimulation Device K201290 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Medline Industries, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k201467/ 2020-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k201467-blood-pressure-monitor-model-2005-2006-fda-510k.jpg K201467 - Blood Pressure Monitor-Model 2005, 2006-2, 2006-2B K201467 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bioland Technology, Ltd.. Cleared Sep 2020. https://www.510kdatabase.net/k200603/ 2020-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k200603-aaa-model-fda-510k.jpg K200603 - AAA Model K200603 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Ultrasound, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k201350/ 2020-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k201350-corvus-fda-510k.jpg K201350 - CORVUS K201350 is a FDA 510(k) cleared radiology medical device. Manufacturer: Best Nomos. Cleared Sep 2020. https://www.510kdatabase.net/k201532/ 2020-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k201532-bj-dvt-calfthigh-garments-models-fda-510k.jpg K201532 - B&J DVT Calf/Thigh Garments, Models 801/830 Series K201532 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: B&J Manufacturing , Ltd.. Cleared Sep 2020. https://www.510kdatabase.net/k190798/ 2020-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k190798-laborview-lv1000-wireless-electrode-fda-510k.jpg K190798 - LaborView™ LV1000 Wireless Electrode System K190798 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Obmedical Company. Cleared Sep 2020. https://www.510kdatabase.net/k192375/ 2020-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k192375-intellifuse-administration-and-fda-510k.jpg K192375 - Intellifuse Administration and Intellifuse Blood Administration Sets K192375 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Smiths Medical Asd, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k192702/ 2020-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k192702-depuy-synthes-craniomaxillofacial-fda-510k.jpg K192702 - DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional K192702 is a FDA 510(k) cleared neurology medical device. Manufacturer: Synthes USA Products, LLC. Cleared Sep 2020. https://www.510kdatabase.net/k192890/ 2020-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k192890-sentep-fda-510k.jpg K192890 - SentEP K192890 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sentiar, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k193368/ 2020-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k193368-smart-correction-system-fda-510k.jpg K193368 - Smart Correction System K193368 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wishbone Medical, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k200174/ 2020-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k200174-dia-root-bio-mta-fda-510k.jpg K200174 - DIA-ROOT BIO MTA K200174 is a FDA 510(k) cleared dental medical device. Manufacturer: DiaDent Group International. Cleared Sep 2020. https://www.510kdatabase.net/k200852/ 2020-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k200852-echopac-software-only-echopac-plug-in-fda-510k.jpg K200852 - EchoPAC Software Only, EchoPAC Plug-In K200852 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared Sep 2020. https://www.510kdatabase.net/k201013/ 2020-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k201013-optixon-1-day-fda-510k.jpg K201013 - Optixon 1-Day K201013 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Optixon, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k201073/ 2020-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k201073-seaspine-waveform-c-interbody-system-fda-510k.jpg K201073 - Seaspine WaveForm C Interbody System K201073 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared Sep 2020. https://www.510kdatabase.net/k201207/ 2020-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k201207-combiset-smartech-hemodialysis-blood-fda-510k.jpg K201207 - CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line K201207 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC. Cleared Sep 2020. https://www.510kdatabase.net/k201224/ 2020-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k201224-electrosurgical-generator-and-fda-510k.jpg K201224 - Electrosurgical Generator and Accessories K201224 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medrange. Cleared Sep 2020. https://www.510kdatabase.net/k201390/ 2020-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k201390-medline-powder-free-light-blue-nitrile-fda-510k.jpg K201390 - Medline Powder-Free Light Blue Nitrile Exam Gloves (Tested for Use with Chemotherapy Drugs) K201390 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industires, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k201538/ 2020-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k201538-life-spine-simpact-sacroiliac-joint-fda-510k.jpg K201538 - Life Spine SIMPACT Sacroiliac Joint Fixation System K201538 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k201547/ 2020-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k201547-bj-dvt-foot-garments-models-820-series-fda-510k.jpg K201547 - B&J DVT Foot Garments, Models 820 Series K201547 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: B&J Manufacturing , Ltd.. Cleared Sep 2020. https://www.510kdatabase.net/k201642/ 2020-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k201642-paragon-adult-maxi-pmp-oxygenator-with-fda-510k.jpg K201642 - Paragon Adult Maxi PMP Oxygenator with Tubing Pack K201642 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Chalice Medical , Ltd.. Cleared Sep 2020. https://www.510kdatabase.net/k201673/ 2020-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k201673-sms-cementless-stem-fda-510k.jpg K201673 - SMS Cementless Stem K201673 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Sep 2020. https://www.510kdatabase.net/k201746/ 2020-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k201746-tempus-pro-patient-monitor-fda-510k.jpg K201746 - Tempus Pro Patient Monitor K201746 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Remote Diagnostic Technologies Limited. Cleared Sep 2020. https://www.510kdatabase.net/k201992/ 2020-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k201992-caption-guidance-fda-510k.jpg K201992 - Caption Guidance K201992 is a FDA 510(k) cleared radiology medical device. Manufacturer: Caption Health. Cleared Sep 2020. https://www.510kdatabase.net/k202022/ 2020-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k202022-gmk-sphere-tibial-inserts-flex-tibial-fda-510k.jpg K202022 - GMK-SPHERE Tibial inserts FLEX Tibial Insert CR and Resurfacing Patella made of E-CROSS (Vitamin E Highly Crosslinked UHMWPE) K202022 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Sep 2020. https://www.510kdatabase.net/k202287/ 2020-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k202287-ran-flex-b-bone-marrow-aspiration-needle-fda-510k.jpg K202287 - Ran-Flex-B Bone Marrow Aspiration Needle K202287 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ranfac Corporation. Cleared Sep 2020. https://www.510kdatabase.net/k202399/ 2020-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k202399-orthobutton-fl-fda-510k.jpg K202399 - OrthoButton FL K202399 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Riverpoint Medical. Cleared Sep 2020. https://www.510kdatabase.net/k202463/ 2020-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k202463-disposable-surgical-mask-fda-510k.jpg K202463 - Disposable Surgical Mask K202463 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Unisources Group, LLC. Cleared Sep 2020. https://www.510kdatabase.net/den200010/ 2020-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/den200010-spineology-interbody-fusion-system-fda-510k.jpg DEN200010 - Spineology Interbody Fusion System DEN200010 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spineology, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k182020/ 2020-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k182020-portable-electro-stimulation-therapy-fda-510k.jpg K182020 - Portable Electro-Stimulation Therapy Device K182020 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Guangzhou Longest Science & Technology Co., Ltd.. Cleared Sep 2020. https://www.510kdatabase.net/k193115/ 2020-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k193115-euroimmun-anti-bp230-cf-elisa-igg-fda-510k.jpg K193115 - EUROIMMUN Anti-BP230-CF ELISA (IgG) K193115 is a FDA 510(k) cleared immunology medical device. Manufacturer: Euroimmun Us, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k201494/ 2020-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k201494-attest-drug-screen-cup-attest-drug-fda-510k.jpg K201494 - ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card K201494 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Advin Biotech, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k201686/ 2020-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k201686-gynecare-tvt-system-gynecare-tvt-with-fda-510k.jpg K201686 - GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™ Introducer and Catheter Guide, GYNECARE TVT EXACT™ Continence System and Trocar, GYNECARE TVT™ Obturator System and Passers and Winged Guide, GYNECARE TVT ABBREVO™ Continence System and Passers and Winged Guide K201686 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ethicon, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k201691/ 2020-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k201691-single-use-surgical-mask-with-ear-loop-fda-510k.jpg K201691 - Single-Use Surgical Mask With Ear Loop K201691 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Qiqihar Hengxin Medical Supplies, Ltd.. Cleared Sep 2020. https://www.510kdatabase.net/k201849/ 2020-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k201849-enat-molecular-collection-and-fda-510k.jpg K201849 - eNAT molecular collection and preservation medium K201849 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Copan Italia Spa. Cleared Sep 2020. https://www.510kdatabase.net/k202007/ 2020-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k202007-lzi-oxycodone-iii-enzyme-immunoassay-fda-510k.jpg K202007 - LZI Oxycodone III Enzyme Immunoassay K202007 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Lin-Zhi International, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k202192/ 2020-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k202192-struxxure-l-and-struxxure-a-plate-system-fda-510k.jpg K202192 - STRUXXURE®-L and STRUXXURE®-A Plate System K202192 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nexxt Spine, LLC. Cleared Sep 2020. https://www.510kdatabase.net/den190032/ 2020-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/den190032-hemosil-liquid-anti-xa-fda-510k.jpg DEN190032 - HemosIL Liquid Anti-Xa DEN190032 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 2020. https://www.510kdatabase.net/den190039/ 2020-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/den190039-toothwave-fda-510k.jpg DEN190039 - ToothWave™ DEN190039 is a FDA 510(k) cleared dental medical device. Manufacturer: Home Skinovations , Ltd.. Cleared Sep 2020. https://www.510kdatabase.net/k200430/ 2020-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k200430-precice-ankle-salvage-system-fda-510k.jpg K200430 - Precice® Ankle Salvage System K200430 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nuvasive Specialized Orthopedics, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k200469/ 2020-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k200469-papaya-3d-premium-papaya-3d-premium-plus-fda-510k.jpg K200469 - PAPAYA 3D Premium & PAPAYA 3D Premium Plus K200469 is a FDA 510(k) cleared radiology medical device. Manufacturer: Genoray Co., Ltd.. Cleared Sep 2020. https://www.510kdatabase.net/k201298/ 2020-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k201298-vx1-fda-510k.jpg K201298 - VX1 K201298 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Volta Medical. Cleared Sep 2020. https://www.510kdatabase.net/k201369/ 2020-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k201369-ava-augmented-vascular-analysis-fda-510k.jpg K201369 - AVA (Augmented Vascular Analysis) K201369 is a FDA 510(k) cleared radiology medical device. Manufacturer: See-Mode Technologies Pte, Ltd.. Cleared Sep 2020. https://www.510kdatabase.net/k201661/ 2020-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k201661-symphony-navigation-ready-instruments-fda-510k.jpg K201661 - Symphony Navigation Ready Instruments and Universal Navigation Adaptor Set K201661 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International SARL. Cleared Sep 2020. https://www.510kdatabase.net/k201774/ 2020-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k201774-polychloroprene-powder-free-sterile-fda-510k.jpg K201774 - Polychloroprene Powder Free Sterile Surgical Gloves, Low Dermatitis Potential and Tested for Use with Chemotherapy Drugs K201774 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Pt. Medisafe Technologies. Cleared Sep 2020. https://www.510kdatabase.net/k202286/ 2020-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k202286-tulsa-pro-system-fda-510k.jpg K202286 - Tulsa-Pro System K202286 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Profound Medical, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k202360/ 2020-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k202360-ziehm-vision-rfd-3d-fda-510k.jpg K202360 - Ziehm Vision RFD 3D K202360 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ziehm Imaging GmbH. Cleared Sep 2020. https://www.510kdatabase.net/k202394/ 2020-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k202394-eosedge-fda-510k.jpg K202394 - EOSedge K202394 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eos Imaging. Cleared Sep 2020. https://www.510kdatabase.net/k202406/ 2020-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k202406-butterfly-iq-ultrasound-system-fda-510k.jpg K202406 - Butterfly iQ Ultrasound System K202406 is a FDA 510(k) cleared radiology medical device. Manufacturer: Butterfly Network, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k192665/ 2020-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k192665-accelerate-pheno-system-accelerate-fda-510k.jpg K192665 - Accelerate Pheno System, Accelerate PhenoTest BC Kit K192665 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Accelerate Diagnostics, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k201170/ 2020-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k201170-athletis-pta-balloon-dilatation-catheter-fda-510k.jpg K201170 - Athletis PTA Balloon Dilatation Catheter K201170 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Sep 2020. https://www.510kdatabase.net/k201341/ 2020-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k201341-acqmap-3d-imaging-and-mapping-catheter-fda-510k.jpg K201341 - AcQMap 3D Imaging and Mapping Catheter K201341 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Acutus Medical, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k201645/ 2020-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k201645-massage-compression-boots-fda-510k.jpg K201645 - Massage Compression Boots K201645 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Jkh USA, LLC. Cleared Sep 2020. https://www.510kdatabase.net/k201656/ 2020-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k201656-arix-elbow-system-fda-510k.jpg K201656 - ARIX Elbow System K201656 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Jeil Medical Corporation. Cleared Sep 2020. https://www.510kdatabase.net/k201664/ 2020-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k201664-firebird-si-fusion-system-fda-510k.jpg K201664 - FIREBIRD SI Fusion System K201664 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthofix, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k201665/ 2020-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k201665-collaboration-live-fda-510k.jpg K201665 - Collaboration Live K201665 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Ultrasound, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k202347/ 2020-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k202347-unifuse-infusion-system-with-cooper-wire-fda-510k.jpg K202347 - UNIFUSE Infusion System with Cooper Wire K202347 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: AngioDynamics, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k200313/ 2020-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k200313-vivo-fda-510k.jpg K200313 - VIVO K200313 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Catheter Precision, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k200343/ 2020-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k200343-fusionframe-ring-lock-system-fda-510k.jpg K200343 - FusionFrame Ring Lock System K200343 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Glw Medical Innovation. Cleared Sep 2020. https://www.510kdatabase.net/k200862/ 2020-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k200862-feelix-stethoscope-fda-510k.jpg K200862 - Feelix Stethoscope K200862 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sonavi Labs, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k201631/ 2020-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k201631-versawrap-nerve-protector-fda-510k.jpg K201631 - VersaWrap Nerve Protector K201631 is a FDA 510(k) cleared neurology medical device. Manufacturer: Alafair Biosciences, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k201646/ 2020-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k201646-shoreline-acs-anterior-cervical-system-fda-510k.jpg K201646 - Shoreline ACS (Anterior Cervical System) K201646 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared Sep 2020. https://www.510kdatabase.net/k202227/ 2020-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k202227-artus-cervical-plate-system-fda-510k.jpg K202227 - Artus™ cervical plate system K202227 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ulrich GmbH & Co. KG. Cleared Sep 2020. https://www.510kdatabase.net/k202318/ 2020-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k202318-marathon-flow-directed-micro-catheter-fda-510k.jpg K202318 - Marathon Flow Directed Micro Catheter K202318 is a FDA 510(k) cleared neurology medical device. Manufacturer: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. Cleared Sep 2020. https://www.510kdatabase.net/k193657/ 2020-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k193657-disposable-enteral-feeding-syringe-fda-510k.jpg K193657 - Disposable Enteral Feeding Syringe with Enfit Connector K193657 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Shinva Ande Healthcare Apparatus Co., Ltd.. Cleared Sep 2020. https://www.510kdatabase.net/k191639/ 2020-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k191639-tk-insulin-syringe-withwithout-saftey-fda-510k.jpg K191639 - TK Insulin Syringe with/without Saftey Retractable Device K191639 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Anhui Tiankang Medical Technology Co., Ltd.. Cleared Sep 2020. https://www.510kdatabase.net/k192137/ 2020-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k192137-intellivue-patient-monitor-mx500-fda-510k.jpg K192137 - IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550 K192137 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Philips Medizin Systeme Boeblingen GmbH. Cleared Sep 2020. https://www.510kdatabase.net/k193340/ 2020-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k193340-gochek-blood-glucose-monitoring-system-fda-510k.jpg K193340 - GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose Monitoring System K193340 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Microtech Medical, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k193449/ 2020-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k193449-electric-breast-pump-model-kp03301-fda-510k.jpg K193449 - Electric Breast Pump (model KP033_01), Electric Double Breast Pump (model KP053_01) K193449 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Guangdong Horigen Mother & Baby Products Co., Ltd.. Cleared Sep 2020. https://www.510kdatabase.net/k200530/ 2020-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k200530-amicus-separator-system-fda-510k.jpg K200530 - AMICUS Separator System K200530 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fresenius Kabi AG. Cleared Sep 2020. https://www.510kdatabase.net/k200854/ 2020-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k200854-depuy-pinnacle-dual-mobility-liner-fda-510k.jpg K200854 - DePuy PINNACLE Dual Mobility Liner K200854 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Ireland UC. Cleared Sep 2020. https://www.510kdatabase.net/k200948/ 2020-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k200948-fitbit-ecg-app-fda-510k.jpg K200948 - Fitbit ECG App K200948 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Fitbit, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k201315/ 2020-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k201315-perform-humeral-system-stem-fda-510k.jpg K201315 - PERFORM Humeral System – Stem K201315 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tornier, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k201333/ 2020-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k201333-saber-035-pta-dilatation-catheter-fda-510k.jpg K201333 - SABER .035 PTA Dilatation Catheter K201333 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corporation. Cleared Sep 2020. https://www.510kdatabase.net/k201506/ 2020-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k201506-talos-c-cervical-intervertebral-body-fda-510k.jpg K201506 - Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System K201506 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Meditech Spine, LLC. Cleared Sep 2020. https://www.510kdatabase.net/k201570/ 2020-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k201570-pf4-enhanced-assay-fda-510k.jpg K201570 - PF4 Enhanced assay K201570 is a FDA 510(k) cleared hematology medical device. Manufacturer: Immucor Gti Diagnostics, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k201779/ 2020-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k201779-hotdog-temperature-management-controller-fda-510k.jpg K201779 - HotDog Temperature Management Controller K201779 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Augustine Temperature Management. Cleared Sep 2020. https://www.510kdatabase.net/k201859/ 2020-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k201859-porcine-mineral-collagen-composite-fda-510k.jpg K201859 - Porcine Mineral Collagen Composite Moldable K201859 is a FDA 510(k) cleared dental medical device. Manufacturer: Collagen Matrix, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k201959/ 2020-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k201959-depuy-synthes-27mm-va-lcp-clavicle-fda-510k.jpg K201959 - DePuy Synthes 2.7mm VA LCP Clavicle Hook Plate System K201959 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Synthes. Cleared Sep 2020. https://www.510kdatabase.net/k202143/ 2020-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k202143-dynex-micro-fda-510k.jpg K202143 - Dynex Micro K202143 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Vilex, LLC. Cleared Sep 2020. https://www.510kdatabase.net/k202187/ 2020-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k202187-flex-vessel-prep-system-fda-510k.jpg K202187 - FLEX Vessel Prep System K202187 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Venturemed Group, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k202297/ 2020-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k202297-aline-ablation-intelligence-fda-510k.jpg K202297 - Aline Ablation Intelligence K202297 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mirada Medical, Ltd.. Cleared Sep 2020. https://www.510kdatabase.net/k193212/ 2020-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k193212-dsm-biomedical-dental-bone-graft-plus-fda-510k.jpg K193212 - DSM Biomedical Dental Bone Graft Plus K193212 is a FDA 510(k) cleared dental medical device. Manufacturer: Dsm Biomedical. Cleared Sep 2020. https://www.510kdatabase.net/k200135/ 2020-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k200135-rgk-daily-range-wheelchairs-fda-510k.jpg K200135 - RGK Daily Range Wheelchairs K200135 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Rgk Wheelchairs, Ltd.. Cleared Sep 2020. https://www.510kdatabase.net/k200845/ 2020-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k200845-navigation-module-of-the-momentum-system-fda-510k.jpg K200845 - Navigation Module of the Momentum System K200845 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ulrich Medical USA. Cleared Sep 2020. https://www.510kdatabase.net/k201145/ 2020-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k201145-x-pac-expandable-lumbar-cage-system-fda-510k.jpg K201145 - X-Pac Expandable Lumbar Cage System K201145 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Expanding Innovations, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k201330/ 2020-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k201330-tigereye-cto-crossing-catheter-fda-510k.jpg K201330 - Tigereye CTO-Crossing Catheter K201330 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Avinger, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k201407/ 2020-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k201407-cd-horizon-spinal-system-fda-510k.jpg K201407 - CD Horizon™ Spinal System K201407 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k201450/ 2020-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k201450-straight-t-clear-dental-aligner-fda-510k.jpg K201450 - Straight T Clear Dental Aligner K201450 is a FDA 510(k) cleared dental medical device. Manufacturer: Straight T, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k201731/ 2020-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k201731-diode-laser-body-sculpture-system-fda-510k.jpg K201731 - Diode Laser Body Sculpture System K201731 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shanghai Apolo Medical Technology Co., Ltd.. Cleared Sep 2020. https://www.510kdatabase.net/k201738/ 2020-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k201738-subnovii-advanced-plasma-technology-fda-510k.jpg K201738 - SubNovii Advanced Plasma Technology K201738 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cartessa Aesthetics. Cleared Sep 2020. https://www.510kdatabase.net/k201909/ 2020-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k201909-rxsight-contact-lens-fda-510k.jpg K201909 - RxSight Contact Lens K201909 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Rxsight, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k201944/ 2020-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k201944-depuy-synthes-24mm-ti-self-tapping-fda-510k.jpg K201944 - DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) K201944 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes USA Products, LLC. Cleared Sep 2020. https://www.510kdatabase.net/k202008/ 2020-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k202008-disposable-vinyl-glove-fda-510k.jpg K202008 - Disposable Vinyl Glove K202008 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Best Care Trading Co., Ltd.. Cleared Sep 2020. https://www.510kdatabase.net/k202156/ 2020-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k202156-diamond-5a6a8a-fda-510k.jpg K202156 - DIAMOND-5A/6A/8A K202156 is a FDA 510(k) cleared radiology medical device. Manufacturer: DRGEM Corporation. Cleared Sep 2020. https://www.510kdatabase.net/k202242/ 2020-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k202242-hs-fiber-fda-510k.jpg K202242 - HS Fiber K202242 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Riverpoint Medical, LLC. Cleared Sep 2020. https://www.510kdatabase.net/k192423/ 2020-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k192423-mint-product-family-fda-510k.jpg K192423 - MINT Product Family K192423 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Hans Biomed Corporation. Cleared Sep 2020. https://www.510kdatabase.net/k192653/ 2020-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k192653-perseus-fda-510k.jpg K192653 - Perseus K192653 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthokey Italia S.R.L.. Cleared Sep 2020. https://www.510kdatabase.net/k192730/ 2020-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k192730-calcium-cresolphthalein-glucose-fda-510k.jpg K192730 - CALCIUM-CRESOLPHTHALEIN, GLUCOSE, UREA/BUN-UV K192730 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Biosystems S.A.. Cleared Sep 2020. https://www.510kdatabase.net/k192822/ 2020-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k192822-benesta-hysteroscope-fda-510k.jpg K192822 - Benesta Hysteroscope K192822 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Caldera Medical, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k193409/ 2020-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k193409-vista-rinse-vista-rinse-plus-fda-510k.jpg K193409 - Vista Rinse, Vista Rinse Plus K193409 is a FDA 510(k) cleared dental medical device. Manufacturer: Inter-Med/Vista Dental Products. Cleared Sep 2020. https://www.510kdatabase.net/k193462/ 2020-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k193462-clottriever-thrombectomy-system-fda-510k.jpg K193462 - ClotTriever Thrombectomy System K193462 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inari Medical. Cleared Sep 2020. https://www.510kdatabase.net/k193664/ 2020-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k193664-subqkath-catheter-and-needle-set-fda-510k.jpg K193664 - SubQKath Catheter and Needle Set K193664 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Hk Surgical. Cleared Sep 2020. https://www.510kdatabase.net/k200027/ 2020-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k200027-blood-collection-needle-withwithout-fda-510k.jpg K200027 - Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter K200027 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Caina Medical Co.,Ltd. Cleared Sep 2020. https://www.510kdatabase.net/k200708/ 2020-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k200708-vivid-iq-fda-510k.jpg K200708 - Vivid iq K200708 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems Ultrasound And. Cleared Sep 2020. https://www.510kdatabase.net/k200851/ 2020-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k200851-vivid-t8-vivid-t9-fda-510k.jpg K200851 - Vivid T8, Vivid T9 K200851 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared Sep 2020. https://www.510kdatabase.net/k201090/ 2020-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k201090-structur-cad-fda-510k.jpg K201090 - Structur CAD K201090 is a FDA 510(k) cleared dental medical device. Manufacturer: Voco GmbH. Cleared Sep 2020. https://www.510kdatabase.net/k201252/ 2020-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k201252-spectralis-hraoct-and-variants-fda-510k.jpg K201252 - Spectralis HRA+OCT and variants K201252 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Heidelberg Engineering GmbH. Cleared Sep 2020. https://www.510kdatabase.net/k201539/ 2020-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k201539-keeogo-dermoskeleton-system-fda-510k.jpg K201539 - Keeogo Dermoskeleton System K201539 is a FDA 510(k) cleared neurology medical device. Manufacturer: B-Temia, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k201551/ 2020-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k201551-ketosens-bt-blood-b-ketone-monitoring-fda-510k.jpg K201551 - KetoSens BT Blood B-Ketone Monitoring System K201551 is a FDA 510(k) cleared chemistry medical device. Manufacturer: I-Sens, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k201578/ 2020-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k201578-depuy-synthes-variable-angle-locking-fda-510k.jpg K201578 - DePuy Synthes Variable Angle Locking Patella Plating System K201578 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes USA Products, LLC. Cleared Sep 2020. https://www.510kdatabase.net/k201829/ 2020-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k201829-sensicare-pi-evolution-surgical-glove-fda-510k.jpg K201829 - SensiCare PI Evolution Surgical Glove (Tested for Use with Chemotherapy Drugs) K201829 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k201948/ 2020-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k201948-acrodti-visualizer-fda-510k.jpg K201948 - AcroDTI Visualizer K201948 is a FDA 510(k) cleared radiology medical device. Manufacturer: Acroviz, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k202153/ 2020-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k202153-responsive-arthroscopy-suture-anchor-fda-510k.jpg K202153 - Responsive Arthroscopy Suture Anchor System K202153 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Responsive Arthroscopy, LLC. Cleared Sep 2020. https://www.510kdatabase.net/k202256/ 2020-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k202256-3shape-implant-studio-fda-510k.jpg K202256 - 3Shape Implant Studio K202256 is a FDA 510(k) cleared radiology medical device. Manufacturer: 3Shape Medical A/S. Cleared Sep 2020. https://www.510kdatabase.net/k201194/ 2020-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k201194-acuity-200-fluoroxyfocon-a-rigid-gas-fda-510k.jpg K201194 - Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens K201194 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Acuity Polymers, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k201470/ 2020-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k201470-disposable-medical-face-mask-fda-510k.jpg K201470 - Disposable Medical Face Mask K201470 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jkh USA, LLC. Cleared Sep 2020. https://www.510kdatabase.net/k202014/ 2020-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k202014-magnetom-aera-magnetom-skyra-magnetom-fda-510k.jpg K202014 - Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fit K202014 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k202252/ 2020-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k202252-asahi-corsair-armet-18-microcatheter-fda-510k.jpg K202252 - ASAHI Corsair Armet 18 Microcatheter (Model: CSAR060-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR090-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR110-18N), ASAHI Corsair Armet 18 Microcatheter (Model: CSAR135-18N), K202252 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Asahi Intecc Co., Ltd.. Cleared Sep 2020. https://www.510kdatabase.net/k202328/ 2020-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k202328-cd-horizon-spinal-system-fda-510k.jpg K202328 - CD Horizon Spinal System K202328 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k202354/ 2020-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k202354-surgical-mask-model-number-cw01-fda-510k.jpg K202354 - Surgical Mask-Model Number CW01 K202354 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hunan Heng Chang Pharmaceutical Co., Ltd.. Cleared Sep 2020. https://www.510kdatabase.net/k201841/ 2020-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k201841-eyebox-fda-510k.jpg K201841 - EyeBOX K201841 is a FDA 510(k) cleared neurology medical device. Manufacturer: Oculogica, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k190561/ 2020-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k190561-nicu-v02-fda-510k.jpg K190561 - NICU V'02 K190561 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Cosmed Nordic Aps. Cleared Sep 2020. https://www.510kdatabase.net/k192524/ 2020-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k192524-lumipulse-g-ca15-3-fda-510k.jpg K192524 - Lumipulse G CA15-3 K192524 is a FDA 510(k) cleared immunology medical device. Manufacturer: Fujirebio Diagnostics,Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k192538/ 2020-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k192538-bd-syringe-nrfit-lok-and-bd-syringe-fda-510k.jpg K192538 - BD Syringe NRFit Lok and BD Syringe NRFit Slip K192538 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson and Company. Cleared Sep 2020. https://www.510kdatabase.net/k193341/ 2020-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k193341-ictmotor-wl-1-fda-510k.jpg K193341 - iCTmotor (WL-1) K193341 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentium Co., Ltd.. Cleared Sep 2020. https://www.510kdatabase.net/k193439/ 2020-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k193439-mebo-wound-dressing-fda-510k.jpg K193439 - MEBO Wound Dressing K193439 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Mebo Life Science, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k193655/ 2020-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k193655-msls6qf-tenspms-device-fda-510k.jpg K193655 - MSLS6QF TENS/PMS Device K193655 is a FDA 510(k) cleared neurology medical device. Manufacturer: Self Doctor Care, LLC. Cleared Sep 2020. https://www.510kdatabase.net/k200835/ 2020-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k200835-3m-tegaderm-chg-chlorhexidine-fda-510k.jpg K200835 - 3M Tegaderm CHG Chlorhexidine Gluconate Gel Pad K200835 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3M Company. Cleared Sep 2020. https://www.510kdatabase.net/k201134/ 2020-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k201134-arthrex-nanoscope-system-fda-510k.jpg K201134 - Arthrex NanoScope System K201134 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Arthrex, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k201225/ 2020-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k201225-neodent-implant-system-gm-helix-fda-510k.jpg K201225 - Neodent Implant System - GM Helix Implants 7.0 K201225 is a FDA 510(k) cleared dental medical device. Manufacturer: Jjgc Industria E Comercio DE Materiais Dentarios S.A.. Cleared Sep 2020. https://www.510kdatabase.net/k201517/ 2020-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k201517-plain-surgical-mask-fda-510k.jpg K201517 - Plain Surgical Mask K201517 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Aok Tooling Limited. Cleared Sep 2020. https://www.510kdatabase.net/k201537/ 2020-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k201537-protective-face-mask-for-medical-use-fda-510k.jpg K201537 - Protective Face Mask for Medical Use K201537 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shandong Shengquan New Material Co., Ltd.. Cleared Sep 2020. https://www.510kdatabase.net/k201721/ 2020-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k201721-trulift-expandable-spacer-system-fda-510k.jpg K201721 - TruLift Expandable Spacer System K201721 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k202197/ 2020-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k202197-astopad-patient-warming-system-fda-510k.jpg K202197 - Astopad Patient Warming System K202197 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Stihler Electronic GmbH. Cleared Sep 2020. https://www.510kdatabase.net/k202238/ 2020-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k202238-signa-artist-fda-510k.jpg K202238 - SIGNA Artist K202238 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare (Tianjin) Company Limited. Cleared Sep 2020. https://www.510kdatabase.net/k202335/ 2020-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k202335-ambra-proviewer-fda-510k.jpg K202335 - Ambra ProViewer K202335 is a FDA 510(k) cleared radiology medical device. Manufacturer: Dicom Grid Inc Dba Ambra Health. Cleared Sep 2020. https://www.510kdatabase.net/k192111/ 2020-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k192111-biodegradable-nitrile-examination-fda-510k.jpg K192111 - Biodegradable Nitrile Examination Powder Free Glove, Green K192111 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Top Glove Sdn. Bhd.. Cleared Sep 2020. https://www.510kdatabase.net/k192452/ 2020-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k192452-lyograft-fda-510k.jpg K192452 - Lyograft K192452 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: B. Bruan Surgical, SA. Cleared Sep 2020. https://www.510kdatabase.net/k193599/ 2020-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k193599-bounder-300-power-wheelchair-bounder-fda-510k.jpg K193599 - BOUNDER 300 Power Wheelchair, BOUNDER Plus 300 Power Wheelchair, BOUNDER 450 Power Wheelchair, BIG BOUNDER 600 Power Wheelchair, BIG BOUNDER 1000 Power Wheelchair K193599 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: 21st Century Scientific, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k200102/ 2020-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k200102-mis-dental-implant-system-fda-510k.jpg K200102 - MIS Dental Implant System K200102 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona. Cleared Sep 2020. https://www.510kdatabase.net/k200212/ 2020-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k200212-reprocessed-advisor-hd-grid-mapping-fda-510k.jpg K200212 - Reprocessed Advisor HD Grid Mapping Catheter, Sensor Enabled K200212 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Innovative Health, LLC. Cleared Sep 2020. https://www.510kdatabase.net/k200641/ 2020-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k200641-haloguard-protective-disc-with-chg-fda-510k.jpg K200641 - HaloGUARD Protective Disc with CHG K200641 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Attwill Medical Solutions. Cleared Sep 2020. https://www.510kdatabase.net/k201074/ 2020-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k201074-delta-iii-lithotripter-fda-510k.jpg K201074 - Delta III Lithotripter K201074 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Dornier Medtech America, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k201203/ 2020-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k201203-cliq-aspirator-fda-510k.jpg K201203 - Cliq Aspirator K201203 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Anest Iwata Sparmax Co., Ltd.. Cleared Sep 2020. https://www.510kdatabase.net/k201211/ 2020-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k201211-3mp-color-lcd-monitors-c32s-c32sp-fda-510k.jpg K201211 - 3MP Color LCD Monitors C32S+, C32SP+ K201211 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Beacon Display Technology Co., Ltd.. Cleared Sep 2020. https://www.510kdatabase.net/k201336/ 2020-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k201336-depuy-synthes-tibial-nail-advanced-fda-510k.jpg K201336 - DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm K201336 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes USA Products, LLC. Cleared Sep 2020. https://www.510kdatabase.net/k201522/ 2020-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k201522-arthrex-syndesmosis-tightrope-xp-fda-510k.jpg K201522 - Arthrex Syndesmosis TightRope XP Buttress Plate Implant System K201522 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k201591/ 2020-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k201591-flat-panel-detector-fda-510k.jpg K201591 - Flat Panel Detector K201591 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ka Imaging, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k201769/ 2020-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k201769-cavetto-max-cervical-cage-system-fda-510k.jpg K201769 - Cavetto [MAX] Cervical Cage System K201769 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Neurostructures, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k201900/ 2020-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k201900-3d-graftrasp-system-fda-510k.jpg K201900 - 3D GraftRasp System K201900 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Surgentec. Cleared Sep 2020. https://www.510kdatabase.net/k201966/ 2020-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k201966-7d-surgical-flashlock-1-7d-surgical-fda-510k.jpg K201966 - 7D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D Surgical Flex Array K201966 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 7D Surgical, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k202176/ 2020-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k202176-symetrex-lthd-catheter-symetrex-lthd-fda-510k.jpg K202176 - Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes K202176 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medical Components, Inc. (dba MedComp). Cleared Sep 2020. https://www.510kdatabase.net/k202235/ 2020-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k202235-artpix-drf-fda-510k.jpg K202235 - ArtPIX DRF K202235 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cmt Medical Technologies, Ltd.. Cleared Sep 2020. https://www.510kdatabase.net/k202499/ 2020-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k202499-diamond-digital-sleep-orthotic-ddso-fda-510k.jpg K202499 - Diamond Digital Sleep Orthotic (DDSO) K202499 is a FDA 510(k) cleared dental medical device. Manufacturer: Diamond Orthotic Laboratory. Cleared Sep 2020. https://www.510kdatabase.net/k192704/ 2020-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k192704-endofresh-digestive-endoscopy-system-fda-510k.jpg K192704 - Endofresh Digestive Endoscopy System K192704 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Huizhou Xzing Technology Co., Ltd.. Cleared Sep 2020. https://www.510kdatabase.net/k192830/ 2020-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k192830-bright-temporary-cb-fda-510k.jpg K192830 - Bright Temporary C&B K192830 is a FDA 510(k) cleared dental medical device. Manufacturer: Dmp Dental Industry S.A.. Cleared Sep 2020. https://www.510kdatabase.net/k193405/ 2020-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k193405-simplant-digital-guide-fda-510k.jpg K193405 - Simplant Digital Guide K193405 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona. Cleared Sep 2020. https://www.510kdatabase.net/k193618/ 2020-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k193618-exactechgps-system-fda-510k.jpg K193618 - ExactechGPS System K193618 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Blue Ortho. Cleared Sep 2020. https://www.510kdatabase.net/k200462/ 2020-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k200462-etchpro-etching-gel-fda-510k.jpg K200462 - EtchPro Etching Gel K200462 is a FDA 510(k) cleared dental medical device. Manufacturer: Belport Company, Inc., Gingi-Pak. Cleared Sep 2020. https://www.510kdatabase.net/k200503/ 2020-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k200503-atl-anchors-fda-510k.jpg K200503 - ATL Anchors K200503 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: International Life Sciences. Cleared Sep 2020. https://www.510kdatabase.net/k200516/ 2020-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k200516-oct-camera-id-21101a3-fda-510k.jpg K200516 - OCT-Camera ID 21101A3 K200516 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Optomedical Technologies GmbH. Cleared Sep 2020. https://www.510kdatabase.net/k200812/ 2020-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k200812-verisight-intracardiac-fda-510k.jpg K200812 - VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter K200812 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Philips Image Guided Therapy Corporation. Cleared Sep 2020. https://www.510kdatabase.net/k200827/ 2020-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k200827-locator-r-tx-fda-510k.jpg K200827 - LOCATOR R-Tx K200827 is a FDA 510(k) cleared dental medical device. Manufacturer: Ivory Super Holdco, Incp.. Cleared Sep 2020. https://www.510kdatabase.net/k200833/ 2020-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k200833-rx-1-rhythm-express-remote-cardiac-fda-510k.jpg K200833 - RX-1 Rhythm Express Remote Cardiac Monitoring System K200833 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vivaquant, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k201277/ 2020-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k201277-oral-b-dry-mouth-oral-rinse-fda-510k.jpg K201277 - Oral-B Dry Mouth Oral Rinse K201277 is a FDA 510(k) cleared dental medical device. Manufacturer: The Procter & Gamble Company. Cleared Sep 2020. https://www.510kdatabase.net/k201552/ 2020-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k201552-apollovue-s100-image-system-fda-510k.jpg K201552 - ApolloVue S100 Image System K201552 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Apollo Medical Optics, Ltd.. Cleared Sep 2020. https://www.510kdatabase.net/k201677/ 2020-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k201677-arthrex-mesh-plates-fda-510k.jpg K201677 - Arthrex Mesh Plates K201677 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k201765/ 2020-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k201765-smarthdm-510-system-fda-510k.jpg K201765 - SmartHDM-510 System K201765 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Mesa Laboratories, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k202124/ 2020-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k202124-aesculap-pas-port-proximal-anastomosis-fda-510k.jpg K202124 - Aesculap PAS-Port Proximal Anastomosis System K202124 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k202169/ 2020-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k202169-quantum-pureflow-centrifugal-blood-fda-510k.jpg K202169 - Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22 K202169 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Qura S.R.L. Cleared Sep 2020. https://www.510kdatabase.net/k202182/ 2020-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k202182-zoom-71-55-45-35-reperfusion-catheters-fda-510k.jpg K202182 - ZOOM (71, 55, 45, 35) Reperfusion Catheters K202182 is a FDA 510(k) cleared neurology medical device. Manufacturer: Imperative Care, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k202215/ 2020-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k202215-cobas-bkv-cobas-ebvbkv-control-kit-fda-510k.jpg K202215 - cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit K202215 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Molecular Systems, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k202216/ 2020-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k202216-epiq-series-diagnostic-ultrasound-fda-510k.jpg K202216 - EPIQ Series Diagnostic Ultrasound Systems K202216 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Ultrasound, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k193424/ 2020-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k193424-resolution-360-ultra-clip-fda-510k.jpg K193424 - Resolution 360™ ULTRA Clip K193424 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Sep 2020. https://www.510kdatabase.net/k200724/ 2020-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k200724-victus-femtosecond-laser-platform-fda-510k.jpg K200724 - VICTUS Femtosecond Laser Platform K200724 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Technolas Perfect Vision GmbH. Cleared Sep 2020. https://www.510kdatabase.net/k200916/ 2020-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k200916-patient-administration-set-fda-510k.jpg K200916 - Patient Administration Set K200916 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cyclomedica Australia Pty, Ltd.. Cleared Sep 2020. https://www.510kdatabase.net/k201135/ 2020-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k201135-image1-s-ccu-image1-s-4u-camera-head-fda-510k.jpg K201135 - Image1 S CCU, Image1 S 4U Camera Head K201135 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k201854/ 2020-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k201854-capogen-laser-cap-fda-510k.jpg K201854 - CAPOGEN Laser Cap K201854 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Nature, Inc.redible, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k201920/ 2020-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k201920-endoscope-reprocessor-oer-elite-fda-510k.jpg K201920 - Endoscope Reprocessor OER-Elite K201920 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Sep 2020. https://www.510kdatabase.net/k202160/ 2020-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k202160-sonosite-px-ultrasound-system-sonosite-fda-510k.jpg K202160 - Sonosite PX Ultrasound System, Sonosite SII Ultrasound System, Sonosite iViz Ultrasound System, Sonosite X-Porte Ultrasound System, Sonosite Edge II Ultrasound System, Sonosite Maxx Ultrasound System K202160 is a FDA 510(k) cleared radiology medical device. Manufacturer: FUJIFILM Sonosite, Inc.. Cleared Sep 2020. https://www.510kdatabase.net/k193589/ 2020-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k193589-truetear-intranasal-tear-neurostimulator-fda-510k.jpg K193589 - TrueTear Intranasal Tear Neurostimulator K193589 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Allergan. Cleared Aug 2020. https://www.510kdatabase.net/k201052/ 2020-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k201052-kls-martin-individual-patient-fda-510k.jpg K201052 - KLS Martin Individual Patient Solutions (IPS) Planning System K201052 is a FDA 510(k) cleared neurology medical device. Manufacturer: KLS-Martin L.P.. Cleared Aug 2020. https://www.510kdatabase.net/k201831/ 2020-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k201831-confidence-spinal-cement-system-fda-510k.jpg K201831 - CONFIDENCE Spinal Cement System K201831 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Spine, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k202251/ 2020-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k202251-penumbra-system-penumbra-jet-7-fda-510k.jpg K202251 - Penumbra System (Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology K202251 is a FDA 510(k) cleared neurology medical device. Manufacturer: Penumbra, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k201405/ 2020-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k201405-labpro-data-management-system-fda-510k.jpg K201405 - LabPro Data Management System K201405 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k201432/ 2020-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k201432-masimo-o3-regional-oximeter-system-fda-510k.jpg K201432 - Masimo O3 Regional Oximeter System K201432 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Masimo Corporation. Cleared Aug 2020. https://www.510kdatabase.net/k191041/ 2020-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k191041-orthodontic-fixation-screw-smart-fda-510k.jpg K191041 - Orthodontic Fixation Screw [Smart Anchor Miniscrew] K191041 is a FDA 510(k) cleared dental medical device. Manufacturer: Gni Co., Ltd.. Cleared Aug 2020. https://www.510kdatabase.net/k191938/ 2020-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k191938-fitrelief-tensems-wireless-device-fda-510k.jpg K191938 - FitRelief TENS&EMS Wireless Device K191938 is a FDA 510(k) cleared neurology medical device. Manufacturer: Heat IN A Click, LLC. Cleared Aug 2020. https://www.510kdatabase.net/k192671/ 2020-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k192671-hemostatic-xerogel-sponge-fda-510k.jpg K192671 - Hemostatic Xerogel Sponge K192671 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Solaplus Biotech Co., Ltd.. Cleared Aug 2020. https://www.510kdatabase.net/k193005/ 2020-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k193005-dimi-rrt-system-fda-510k.jpg K193005 - DIMI RRT System K193005 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Dialco Medical, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k200369/ 2020-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k200369-oes-elite-ureteroscopes-and-accessories-fda-510k.jpg K200369 - OES Elite Ureteroscopes and Accessories K200369 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Winter & Ibe GmbH. Cleared Aug 2020. https://www.510kdatabase.net/k200859/ 2020-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k200859-infinity-m300-fda-510k.jpg K200859 - Infinity M300 K200859 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Draeger Medical Systems, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k200926/ 2020-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k200926-orthogold-100-fda-510k.jpg K200926 - OrthoGold 100 K200926 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Tissue Regeneration Technologies, LLC. Cleared Aug 2020. https://www.510kdatabase.net/k200958/ 2020-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k200958-modulif-a-anterior-lumbar-interbody-fda-510k.jpg K200958 - MODULIF-A Anterior Lumbar Interbody Fusion System K200958 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinal Stability, LLC. Cleared Aug 2020. https://www.510kdatabase.net/k201166/ 2020-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k201166-temno-elite-biopsy-system-fda-510k.jpg K201166 - Temno Elite Biopsy System K201166 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k201199/ 2020-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k201199-jada-system-fda-510k.jpg K201199 - Jada System K201199 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Alydia Health. Cleared Aug 2020. https://www.510kdatabase.net/k201476/ 2020-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k201476-dreamed-advisor-pro-fda-510k.jpg K201476 - DreaMed Advisor Pro K201476 is a FDA 510(k) cleared chemistry medical device. Manufacturer: DreaMed Diabetes, Ltd.. Cleared Aug 2020. https://www.510kdatabase.net/k202099/ 2020-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k202099-aos-galileo-trochanteric-nail-system-fda-510k.jpg K202099 - AOS Galileo™ Trochanteric Nail System K202099 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Advanced Orthopaedic Solutions, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k202108/ 2020-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k202108-external-counterpulsation-system-fda-510k.jpg K202108 - External Counterpulsation System, Soulaire K202108 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vamed Medical Instrument Co., Ltd.. Cleared Aug 2020. https://www.510kdatabase.net/k202224/ 2020-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k202224-spaceoar-system-fda-510k.jpg K202224 - SpaceOAR System K202224 is a FDA 510(k) cleared radiology medical device. Manufacturer: Boston Scientific Corporation. Cleared Aug 2020. https://www.510kdatabase.net/den190042/ 2020-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/den190042-theranova-dialyzers-theranova-400-fda-510k.jpg DEN190042 - Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer DEN190042 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corporation. Cleared Aug 2020. https://www.510kdatabase.net/k190864/ 2020-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k190864-konix-anti-fog-solution-fda-510k.jpg K190864 - Konix Anti-Fog Solution K190864 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler. Cleared Aug 2020. https://www.510kdatabase.net/k192062/ 2020-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k192062-nucleoss-t6-dental-implant-system-fda-510k.jpg K192062 - Nucleoss T6 Dental Implant System K192062 is a FDA 510(k) cleared dental medical device. Manufacturer: Sanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST. Cleared Aug 2020. https://www.510kdatabase.net/k192953/ 2020-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k192953-aptos-threads-polypropylene-surgical-fda-510k.jpg K192953 - APTOS Threads – Polypropylene Surgical Sutures K192953 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aptos, LLC. Cleared Aug 2020. https://www.510kdatabase.net/k200881/ 2020-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k200881-oral-b-io-test-drive-power-brush-trial-fda-510k.jpg K200881 - Oral-B iO Test Drive Power Brush Trial Program Kit K200881 is a FDA 510(k) cleared dental medical device. Manufacturer: The Procter & Gamble Company. Cleared Aug 2020. https://www.510kdatabase.net/k200973/ 2020-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k200973-synapse-3d-cardiac-tools-fda-510k.jpg K200973 - Synapse 3D Cardiac Tools K200973 is a FDA 510(k) cleared radiology medical device. Manufacturer: Fujifilm Corporaton. Cleared Aug 2020. https://www.510kdatabase.net/k201115/ 2020-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k201115-next-generation-balloon-dilation-system-fda-510k.jpg K201115 - Next Generation Balloon Dilation System K201115 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Acclarent, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k201162/ 2020-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k201162-essence-55sp-large-monitor-system-fda-510k.jpg K201162 - Essence 55SP Large Monitor System K201162 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenyang Torch-Bigtide Digital Technology Co., Ltd.. Cleared Aug 2020. https://www.510kdatabase.net/k201807/ 2020-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k201807-ancoris-fda-510k.jpg K201807 - ANCORIS K201807 is a FDA 510(k) cleared radiology medical device. Manufacturer: Miegmbh. Cleared Aug 2020. https://www.510kdatabase.net/k201830/ 2020-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k201830-anser-clavicle-pin-fda-510k.jpg K201830 - ANSER Clavicle Pin K201830 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: BAAT Medical Products B.V.. Cleared Aug 2020. https://www.510kdatabase.net/k201981/ 2020-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k201981-magicore-system-fda-510k.jpg K201981 - Magicore System K201981 is a FDA 510(k) cleared dental medical device. Manufacturer: Innobiosurg Co., Ltd.. Cleared Aug 2020. https://www.510kdatabase.net/k191640/ 2020-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k191640-tk-intravascular-administration-set-fda-510k.jpg K191640 - TK Intravascular Administration Set K191640 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Anhui Tiankang Medical Technology Co., Ltd.. Cleared Aug 2020. https://www.510kdatabase.net/k192863/ 2020-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k192863-mondrian-lumbar-interbody-fusion-cage-fda-510k.jpg K192863 - MONDRIAN Lumbar Interbody Fusion Cage System K192863 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ctl Medical Corporation. Cleared Aug 2020. https://www.510kdatabase.net/k193177/ 2020-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k193177-cer-s-fda-510k.jpg K193177 - CER-S K193177 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cardiocalm. Cleared Aug 2020. https://www.510kdatabase.net/k193653/ 2020-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k193653-hydrophilic-coating-guide-wire-fda-510k.jpg K193653 - Hydrophilic Coating Guide Wire K193653 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Suzhou Hengrui Disheng Medical Co., Ltd.. Cleared Aug 2020. https://www.510kdatabase.net/k200373/ 2020-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k200373-deltaven-fast-flash-closed-iv-catheter-fda-510k.jpg K200373 - Deltaven Fast Flash Closed I.V. Catheter Systems K200373 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Delta Med Spa. Cleared Aug 2020. https://www.510kdatabase.net/k200714/ 2020-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k200714-aview-fda-510k.jpg K200714 - AVIEW K200714 is a FDA 510(k) cleared radiology medical device. Manufacturer: Coreline Soft Co., Ltd.. Cleared Aug 2020. https://www.510kdatabase.net/k200796/ 2020-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k200796-emprint-ablation-system-with-fda-510k.jpg K200796 - Emprint Ablation System with Thermosphere Technology K200796 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien, LLC. Cleared Aug 2020. https://www.510kdatabase.net/k200923/ 2020-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k200923-single-use-surgical-mask-fda-510k.jpg K200923 - Single-use Surgical Mask K200923 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Byd Precision Manufacturer Co., Ltd.. Cleared Aug 2020. https://www.510kdatabase.net/k201020/ 2020-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k201020-briefcase-fda-510k.jpg K201020 - BriefCase K201020 is a FDA 510(k) cleared radiology medical device. Manufacturer: Aidoc Medical , Ltd.. Cleared Aug 2020. https://www.510kdatabase.net/k201141/ 2020-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k201141-firmm-fda-510k.jpg K201141 - FIRMM K201141 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nous Imaging, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k201267/ 2020-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k201267-adaptix-interbody-system-with-titan-fda-510k.jpg K201267 - Adaptix Interbody System with Titan nanoLOCK Surface Technology K201267 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Aug 2020. https://www.510kdatabase.net/k201472/ 2020-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k201472-vensure-balloon-device-vensure-nav-fda-510k.jpg K201472 - VenSure Balloon Device, VenSure Nav Balloon Device K201472 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Fiagon GmbH. Cleared Aug 2020. https://www.510kdatabase.net/k201549/ 2020-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k201549-motex-anti-fog-surgical-face-mask-fda-510k.jpg K201549 - Motex Anti-Fog Surgical Face Mask K201549 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Modern Healthcare Corp.. Cleared Aug 2020. https://www.510kdatabase.net/k201805/ 2020-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k201805-versaone-reusable-positioning-trocar-fda-510k.jpg K201805 - VersaOne Reusable Positioning Trocar System K201805 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien. Cleared Aug 2020. https://www.510kdatabase.net/k201856/ 2020-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k201856-provicol-qm-aesthetic-fda-510k.jpg K201856 - Provicol QM Aesthetic K201856 is a FDA 510(k) cleared dental medical device. Manufacturer: Voco GmbH. Cleared Aug 2020. https://www.510kdatabase.net/k202064/ 2020-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k202064-admiral-acp-system-fda-510k.jpg K202064 - Admiral ACP System K202064 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared Aug 2020. https://www.510kdatabase.net/k202072/ 2020-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k202072-mindseye-expandable-port-fda-510k.jpg K202072 - MindsEye Expandable Port K202072 is a FDA 510(k) cleared neurology medical device. Manufacturer: Minnetronix Neuro, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k192464/ 2020-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k192464-injection-pen-needle-fda-510k.jpg K192464 - Injection Pen Needle K192464 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Gangan Medical Technology Jiangsu Co., Ltd.. Cleared Aug 2020. https://www.510kdatabase.net/k192809/ 2020-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k192809-dental-handpiece-fda-510k.jpg K192809 - Dental Handpiece K192809 is a FDA 510(k) cleared dental medical device. Manufacturer: Micro-Nx Co., Ltd.. Cleared Aug 2020. https://www.510kdatabase.net/k193338/ 2020-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k193338-med-link-reusable-temperature-probes-fda-510k.jpg K193338 - Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes K193338 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen Med-Link Electronics Tech Co., Ltd.. Cleared Aug 2020. https://www.510kdatabase.net/k193522/ 2020-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k193522-imedium-single-step-fda-510k.jpg K193522 - iMedium Single Step K193522 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Kitazato Corporation. Cleared Aug 2020. https://www.510kdatabase.net/k200587/ 2020-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k200587-verasense-for-exactech-equinoxe-size-fda-510k.jpg K200587 - VERASENSE for Exactech Equinoxe Size 38 mm, VERASENSE for Exactech Equinoxe Size 42 mm, LinkStation MINI, LinkStation MINI Evaluation Kit, VERASENSE Software Application for Shoulder K200587 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthosensor, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k201772/ 2020-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k201772-nitrile-powder-free-examination-gloves-fda-510k.jpg K201772 - Nitrile Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) K201772 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hartalega NGC Sdn. Bhd.. Cleared Aug 2020. https://www.510kdatabase.net/k201979/ 2020-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k201979-cervical-plate-system-fda-510k.jpg K201979 - Cervical Plate System K201979 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Eminent Spine, LLC. Cleared Aug 2020. https://www.510kdatabase.net/k192380/ 2020-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k192380-st-aia-pack-bnp-fda-510k.jpg K192380 - ST AIA-PACK BNP K192380 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Fujirebio Diagnostics,Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k193364/ 2020-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k193364-intimate-rose-kegel-exercise-system-fda-510k.jpg K193364 - Intimate Rose Kegel Exercise System K193364 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Plus EV Holdings Dba Intimate Rose. Cleared Aug 2020. https://www.510kdatabase.net/k200695/ 2020-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k200695-matrx-plus-fda-510k.jpg K200695 - MATRx plus K200695 is a FDA 510(k) cleared dental medical device. Manufacturer: Zephyr Sleep Technologies. Cleared Aug 2020. https://www.510kdatabase.net/k202054/ 2020-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k202054-dynex-ring-fixation-system-diametrix-fda-510k.jpg K202054 - Dynex Ring Fixation System, Diametrix Ring Fixation System K202054 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Vilex, LLC. Cleared Aug 2020. https://www.510kdatabase.net/k201505/ 2020-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k201505-simplexa-flu-ab-rsv-direct-gen-ii-fda-510k.jpg K201505 - Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack K201505 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Diasorin Molecular, LLC. Cleared Aug 2020. https://www.510kdatabase.net/k193201/ 2020-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k193201-btl-785f-fda-510k.jpg K193201 - BTL-785F K193201 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Btl. Cleared Aug 2020. https://www.510kdatabase.net/k193260/ 2020-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k193260-u-cem-premium-mazic-cem-fda-510k.jpg K193260 - U-Cem Premium & MAZIC Cem K193260 is a FDA 510(k) cleared dental medical device. Manufacturer: Vericom Co., Ltd.. Cleared Aug 2020. https://www.510kdatabase.net/k200216/ 2020-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k200216-4k-uhd-camera-system-fda-510k.jpg K200216 - 4K UHD Camera System K200216 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Scivita Medical Technology Co., Ltd.. Cleared Aug 2020. https://www.510kdatabase.net/k200957/ 2020-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k200957-brainsway-deep-tms-system-fda-510k.jpg K200957 - Brainsway Deep TMS System K200957 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainsway , Ltd.. Cleared Aug 2020. https://www.510kdatabase.net/k201056/ 2020-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k201056-neuroblate-system-fda-510k.jpg K201056 - NeuroBlate System K201056 is a FDA 510(k) cleared neurology medical device. Manufacturer: Monteris Medical, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k201513/ 2020-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k201513-quantra-qplus-system-fda-510k.jpg K201513 - Quantra QPlus System K201513 is a FDA 510(k) cleared hematology medical device. Manufacturer: Hemosonics, LLC. Cleared Aug 2020. https://www.510kdatabase.net/k201693/ 2020-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k201693-dc-90dc-90sdc-90qdc-95dc-95sdc-88dc-fda-510k.jpg K201693 - DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80AExp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System K201693 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Aug 2020. https://www.510kdatabase.net/k201749/ 2020-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k201749-arthrex-swivelock-anchor-fda-510k.jpg K201749 - Arthrex SwiveLock Anchor K201749 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k202036/ 2020-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k202036-focus-dailies-focus-dailies-toric-fda-510k.jpg K202036 - Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal K202036 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Alcon Laboratories, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k202116/ 2020-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k202116-ezdent-i-e2-prora-view-smart-m-viewer-fda-510k.jpg K202116 - EzDent-i/ E2/ Prora View/ Smart M Viewer K202116 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ewoosoft Co., Ltd.. Cleared Aug 2020. https://www.510kdatabase.net/k192291/ 2020-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k192291-tidalport-ap-implantable-apheresis-fda-510k.jpg K192291 - TidalPort-AP Implantable Apheresis Vascular Access Port K192291 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Norfolk Medical Products, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k193318/ 2020-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k193318-distinct-early-detection-pregnancy-test-fda-510k.jpg K193318 - Distinct® Early Detection Pregnancy Test K193318 is a FDA 510(k) cleared chemistry medical device. Manufacturer: ACON Laboratories, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k193578/ 2020-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k193578-non-spermicidal-lubricated-male-latex-fda-510k.jpg K193578 - Non-spermicidal Lubricated Male Latex Condom K193578 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Global Protection Corp.. Cleared Aug 2020. https://www.510kdatabase.net/k200093/ 2020-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k200093-synthetic-nitrile-patient-exam-gloves-fda-510k.jpg K200093 - Synthetic Nitrile Patient Exam Gloves, Powder Free, Blue, Tested for Use w/Chemotherapy Drug K200093 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Anhui Lntco Medical Products Co., Ltd.. Cleared Aug 2020. https://www.510kdatabase.net/k200586/ 2020-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k200586-straumann-tlx-implant-system-fda-510k.jpg K200586 - Straumann TLX Implant System K200586 is a FDA 510(k) cleared dental medical device. Manufacturer: Institut Straumann AG. Cleared Aug 2020. https://www.510kdatabase.net/k200939/ 2020-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k200939-electronic-blood-pressure-monitor-fda-510k.jpg K200939 - Electronic Blood Pressure Monitor K200939 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Jiangsu Yuyue Medical Equipment& Supply Co., Ltd.. Cleared Aug 2020. https://www.510kdatabase.net/k201636/ 2020-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k201636-hercules-suture-anchor-system-fda-510k.jpg K201636 - Hercules Suture Anchor System K201636 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: In2bones USA, LLC. Cleared Aug 2020. https://www.510kdatabase.net/k202130/ 2020-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k202130-fujifilm-video-laparoscope-fda-510k.jpg K202130 - FUJIFILM Video Laparoscope K202130 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Fujifilm Corporation. Cleared Aug 2020. https://www.510kdatabase.net/k192275/ 2020-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k192275-invisa-red-elite-fda-510k.jpg K192275 - invisa-RED ELITE K192275 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: IR Technology, LLC. Cleared Aug 2020. https://www.510kdatabase.net/k193476/ 2020-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k193476-varilymph-12-pro-fda-510k.jpg K193476 - VariLymph 12 pro K193476 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Slk Medical GmbH. Cleared Aug 2020. https://www.510kdatabase.net/k193537/ 2020-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k193537-omnichroma-flow-fda-510k.jpg K193537 - Omnichroma Flow K193537 is a FDA 510(k) cleared dental medical device. Manufacturer: Tokuyama Dental Corporation. Cleared Aug 2020. https://www.510kdatabase.net/k193563/ 2020-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k193563-medline-renewal-reprocessed-harmonic-fda-510k.jpg K193563 - Medline ReNewal Reprocessed Harmonic ACE+7 Shears K193563 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Surgical Instrument Service and Savings Inc.(Dba Medline Ren. Cleared Aug 2020. https://www.510kdatabase.net/k193595/ 2020-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k193595-indigo-aspiration-system-aspiration-fda-510k.jpg K193595 - Indigo Aspiration System - Aspiration Catheter 7 and Separator 7 K193595 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Penumbra, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k200033/ 2020-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k200033-hemosil-von-willebrand-factor-antigen-fda-510k.jpg K200033 - HemosIL von Willebrand Factor Antigen K200033 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Aug 2020. https://www.510kdatabase.net/k200191/ 2020-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k200191-sirona-dental-cadcam-system-with-inlab-fda-510k.jpg K200191 - Sirona Dental CAD/CAM System with InLab Software K200191 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona. Cleared Aug 2020. https://www.510kdatabase.net/k200597/ 2020-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k200597-straumann-blx-gold-abutments-fda-510k.jpg K200597 - Straumann BLX Gold Abutments K200597 is a FDA 510(k) cleared dental medical device. Manufacturer: Straumann USA, LLC (On Behalf of Institut Straumann Ag). Cleared Aug 2020. https://www.510kdatabase.net/k201137/ 2020-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k201137-asept-surgical-face-mask-fda-510k.jpg K201137 - Asept Surgical Face Mask K201137 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Pfm Medical, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k201360/ 2020-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k201360-reusable-and-disposable-spo2-sensors-fda-510k.jpg K201360 - Reusable and Disposable SpO2 Sensors K201360 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Xinkang Medical Instrument Co. , Ltd.. Cleared Aug 2020. https://www.510kdatabase.net/k201362/ 2020-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k201362-cd-horizon-fenestrated-screw-set-cd-fda-510k.jpg K201362 - CD Horizon™ Fenestrated Screw Set, CD Horizon™ Spinal System, Kyphon™ HV-R™ Bone Cement K201362 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic. Cleared Aug 2020. https://www.510kdatabase.net/k201995/ 2020-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k201995-cubescan-biocon-1100-fda-510k.jpg K201995 - CUBEScan BioCon-1100 K201995 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mcube Technology Co., Ltd.. Cleared Aug 2020. https://www.510kdatabase.net/k202050/ 2020-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k202050-cranial-4pi-immobilization-fda-510k.jpg K202050 - Cranial 4Pi Immobilization K202050 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab AG. Cleared Aug 2020. https://www.510kdatabase.net/k190600/ 2020-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k190600-orion-spinal-system-fda-510k.jpg K190600 - ORION Spinal System K190600 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orion Biotech, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k191591/ 2020-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k191591-bb-base-3d-printing-resin-for-denture-fda-510k.jpg K191591 - BB Base 3D printing resin for denture base K191591 is a FDA 510(k) cleared dental medical device. Manufacturer: Enlighten Materials Co., Ltd.. Cleared Aug 2020. https://www.510kdatabase.net/k192723/ 2020-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k192723-coloring-liquid-fda-510k.jpg K192723 - Coloring Liquid K192723 is a FDA 510(k) cleared dental medical device. Manufacturer: Aidite (Qinhuangdao) Technology Co., Ltd.. Cleared Aug 2020. https://www.510kdatabase.net/k201334/ 2020-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k201334-keystone-dental-xl-dental-implant-system-fda-510k.jpg K201334 - Keystone Dental XL Dental Implant System K201334 is a FDA 510(k) cleared dental medical device. Manufacturer: Keystone Dental, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k202012/ 2020-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k202012-mammotome-revolve-dual-vacuum-assisted-fda-510k.jpg K202012 - Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System K202012 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Devicor Medical Products, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k192597/ 2020-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k192597-cytrans-granules-fda-510k.jpg K192597 - Cytrans Granules K192597 is a FDA 510(k) cleared dental medical device. Manufacturer: GC America, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k192845/ 2020-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k192845-sperm-freeze-sperm-fridge-fda-510k.jpg K192845 - Sperm Freeze, Sperm Fridge K192845 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Kitazato Corporation. Cleared Aug 2020. https://www.510kdatabase.net/k193240/ 2020-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k193240-universal-cylinder-applicator-family-fda-510k.jpg K193240 - Universal Cylinder Applicator Family K193240 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k193492/ 2020-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k193492-23andme-personal-genome-service-pgs-fda-510k.jpg K193492 - 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports K193492 is a FDA 510(k) cleared chemistry medical device. Manufacturer: 23AndMe, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k200648/ 2020-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k200648-ekos-pe-endovascular-device-with-fda-510k.jpg K200648 - EKOS PE Endovascular Device with Control System 4.0 (CS4.0) K200648 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ekos Corporation. Cleared Aug 2020. https://www.510kdatabase.net/k201159/ 2020-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k201159-wallflex-colonic-stent-system-with-fda-510k.jpg K201159 - WallFlex Colonic Stent System with Anchor Lock Delivery System K201159 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Aug 2020. https://www.510kdatabase.net/k201177/ 2020-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k201177-radgil2-fda-510k.jpg K201177 - RadGil2 K201177 is a FDA 510(k) cleared radiology medical device. Manufacturer: R3 X-Ray L.L.C. Cleared Aug 2020. https://www.510kdatabase.net/k201352/ 2020-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k201352-3d-auto-laa-fda-510k.jpg K201352 - 3D Auto LAA K201352 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Health Care. Cleared Aug 2020. https://www.510kdatabase.net/k201399/ 2020-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k201399-hopkins-icgnir-10mm-ridgid-endoscope-fda-510k.jpg K201399 - HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 4mm Ridgid Endoscope 0°, 30°, 45°, VITOM II ICG/NIR Telescope, Power LED Rubina Light Source, Foot Switch, Fiber Optic Light Cable, Image S CCU, Image S 4U Rubina Camera Head K201399 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k193408/ 2020-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k193408-sirona-dental-cadcam-system-with-cerec-fda-510k.jpg K193408 - Sirona Dental CAD/CAM System with CEREC Chairside Software K193408 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona. Cleared Aug 2020. https://www.510kdatabase.net/k191708/ 2020-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k191708-origin-stem-evolve-stem-aria-hip-stem-fda-510k.jpg K191708 - Origin Stem, Evolve Stem, Aria Hip Stem, Remedy Stem, CoCr Femoral Head K191708 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Signature Orthopaedics Pty, Ltd.. Cleared Aug 2020. https://www.510kdatabase.net/k192682/ 2020-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k192682-orthocem-ortho-bite-fda-510k.jpg K192682 - Orthocem, Ortho Bite K192682 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentscare Ltda. Cleared Aug 2020. https://www.510kdatabase.net/k200064/ 2020-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k200064-osteoflo-nanoputty-quadphasic-fda-510k.jpg K200064 - OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft K200064 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SurGenTec, LLC. Cleared Aug 2020. https://www.510kdatabase.net/k200775/ 2020-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k200775-loop-led-curing-light-system-fda-510k.jpg K200775 - LOOP LED Curing Light System K200775 is a FDA 510(k) cleared dental medical device. Manufacturer: Garrison Dental Solutions, LLC. Cleared Aug 2020. https://www.510kdatabase.net/k200848/ 2020-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k200848-stimulator-stimulator-kit-external-fda-510k.jpg K200848 - Stimulator, Stimulator Kit, External Transmitter, External Transmitter Kit K200848 is a FDA 510(k) cleared neurology medical device. Manufacturer: Micron Medical Corporation. Cleared Aug 2020. https://www.510kdatabase.net/k201010/ 2020-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k201010-infinix-universal-composite-infinix-fda-510k.jpg K201010 - Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite K201010 is a FDA 510(k) cleared dental medical device. Manufacturer: Nobio , Ltd.. Cleared Aug 2020. https://www.510kdatabase.net/k201518/ 2020-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k201518-route-92-medical-088-access-system-fda-510k.jpg K201518 - Route 92 Medical 088 Access System K201518 is a FDA 510(k) cleared neurology medical device. Manufacturer: Route 92 Medical. Cleared Aug 2020. https://www.510kdatabase.net/k201632/ 2020-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k201632-tomtec-arena-fda-510k.jpg K201632 - TOMTEC-ARENA K201632 is a FDA 510(k) cleared radiology medical device. Manufacturer: Tomtec Imaging Systems GmbH. Cleared Aug 2020. https://www.510kdatabase.net/k202068/ 2020-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k202068-the-aio-solution-30-fda-510k.jpg K202068 - The AIO Solution 3.0 K202068 is a FDA 510(k) cleared radiology medical device. Manufacturer: Orfit Industries NV. Cleared Aug 2020. https://www.510kdatabase.net/k202276/ 2020-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k202276-bracepaste-band-and-build-lc-fda-510k.jpg K202276 - BracePaste Band and Build LC K202276 is a FDA 510(k) cleared dental medical device. Manufacturer: American Orthodontics. Cleared Aug 2020. https://www.510kdatabase.net/k181645/ 2020-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k181645-stimawell-120mtrs-fda-510k.jpg K181645 - StimaWELL 120MTRS K181645 is a FDA 510(k) cleared neurology medical device. Manufacturer: Pierenkemper GmbH. Cleared Aug 2020. https://www.510kdatabase.net/k192611/ 2020-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k192611-cuffix-fda-510k.jpg K192611 - Cuffix K192611 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Biovo Technologies , Ltd.. Cleared Aug 2020. https://www.510kdatabase.net/k192944/ 2020-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k192944-ancestrydna-factor-v-leiden-genetic-fda-510k.jpg K192944 - AncestryDNA Factor V Leiden Genetic Health Risk Test K192944 is a FDA 510(k) cleared hematology medical device. Manufacturer: Ancestry Genomics, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k192947/ 2020-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k192947-ancestrydna-saliva-collection-kit-fda-510k.jpg K192947 - AncestryDNA Saliva Collection Kit K192947 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Ancestry Genomics, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k193046/ 2020-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k193046-straumann-retentive-system-novaloc-tin-fda-510k.jpg K193046 - Straumann® Retentive System – Novaloc TiN Abutments K193046 is a FDA 510(k) cleared dental medical device. Manufacturer: Institut Straumann AG. Cleared Aug 2020. https://www.510kdatabase.net/k193429/ 2020-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k193429-exeter-v40-femoral-stem-exeter-x3-fda-510k.jpg K193429 - Exeter V40 Femoral Stem, Exeter X3 RimFit Cup K193429 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Aug 2020. https://www.510kdatabase.net/k200133/ 2020-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k200133-hcg-urine-test-strip-hcg-urine-test-fda-510k.jpg K200133 - hCG Urine Test Strip, hCG Urine Test Cassette, hCG Urine Test Midstream K200133 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Safecare Biotech (Hangzhou) Co., Ltd.. Cleared Aug 2020. https://www.510kdatabase.net/k200822/ 2020-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k200822-braid-fda-510k.jpg K200822 - Braid K200822 is a FDA 510(k) cleared radiology medical device. Manufacturer: Braid.Health. Cleared Aug 2020. https://www.510kdatabase.net/k200895/ 2020-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k200895-univers-revers-modular-glenoid-system-fda-510k.jpg K200895 - Univers Revers Modular Glenoid System, Half Augment Baseplate K200895 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k201232/ 2020-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k201232-limbus-contour-fda-510k.jpg K201232 - Limbus Contour K201232 is a FDA 510(k) cleared radiology medical device. Manufacturer: Limbus Ai, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k201444/ 2020-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k201444-syngovia-rt-image-suite-fda-510k.jpg K201444 - Syngo.via RT Image Suite K201444 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k201916/ 2020-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k201916-inspire-6m-hollow-fiber-oxygenator-fda-510k.jpg K201916 - Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator, Inspire 8M Hollow Fiber oxygenator K201916 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sorin Group Italia S.R.L.. Cleared Aug 2020. https://www.510kdatabase.net/k201960/ 2020-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k201960-spaceflex-knee-80mm-size-fda-510k.jpg K201960 - SpaceFlex Knee - 80mm Size K201960 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: G21, S.R.L.. Cleared Aug 2020. https://www.510kdatabase.net/k201961/ 2020-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k201961-illuminoss-photodynamic-bone-fda-510k.jpg K201961 - IlluminOss Photodynamic Bone Stabilization System K201961 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Illuminoss Medical, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k192620/ 2020-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k192620-sna-001-silver-photoparticle-topical-gel-fda-510k.jpg K192620 - SNA-001 Silver Photoparticle Topical Gel K192620 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sienna Biopharmaceuticals, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k193312/ 2020-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k193312-uniko-pointcloud-knee-instruments-fda-510k.jpg K193312 - UNIKO PointCloud™ Knee Instruments K193312 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Unik Orthopedics, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k200529/ 2020-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k200529-orion-fda-510k.jpg K200529 - Orion K200529 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Interacoustics A/S. Cleared Aug 2020. https://www.510kdatabase.net/k200534/ 2020-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k200534-visualeyes-fda-510k.jpg K200534 - VisualEyes K200534 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Interacoustics A/S. Cleared Aug 2020. https://www.510kdatabase.net/k200763/ 2020-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k200763-osteo-site-vertebral-balloon-fda-510k.jpg K200763 - Osteo-site Vertebral Balloon K200763 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Izi Medical. Cleared Aug 2020. https://www.510kdatabase.net/k200838/ 2020-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k200838-tyece-otc-tens-model-fda-510k.jpg K200838 - Tyece OTC TENS Model K200838 is a FDA 510(k) cleared neurology medical device. Manufacturer: Tyece Limited. Cleared Aug 2020. https://www.510kdatabase.net/k201054/ 2020-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k201054-somnoscreen-plus-fda-510k.jpg K201054 - SOMNOscreen plus K201054 is a FDA 510(k) cleared neurology medical device. Manufacturer: Somnomedics GmbH. Cleared Aug 2020. https://www.510kdatabase.net/k201099/ 2020-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k201099-bd-phaseal-optima-closed-system-drug-fda-510k.jpg K201099 - BD PhaSeal Optima Closed System Drug Transfer Device K201099 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson and Company. Cleared Aug 2020. https://www.510kdatabase.net/k201174/ 2020-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k201174-trudi-curette-fda-510k.jpg K201174 - TruDi Curette K201174 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Acclarent, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k201248/ 2020-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k201248-syringe-holder-accessory-fda-510k.jpg K201248 - Syringe Holder accessory K201248 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Vapocoolshot, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k201637/ 2020-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k201637-aurora-evacuator-coag-fda-510k.jpg K201637 - Aurora Evacuator +Coag K201637 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Rebound Therapeutics. Cleared Aug 2020. https://www.510kdatabase.net/k201871/ 2020-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k201871-surgical-mask-fda-510k.jpg K201871 - Surgical Mask K201871 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C & S Paper Yunfu Co., Ltd.. Cleared Aug 2020. https://www.510kdatabase.net/k191296/ 2020-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k191296-pointe-scientific-creatinine-kinase-ck-fda-510k.jpg K191296 - Pointe Scientific Creatinine Kinase (CK) Reagent Set K191296 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Medtest DX. Cleared Aug 2020. https://www.510kdatabase.net/k193175/ 2020-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k193175-lateralized-glenosphere-fda-510k.jpg K193175 - Lateralized Glenosphere K193175 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta Inernational SA. Cleared Aug 2020. https://www.510kdatabase.net/k193264/ 2020-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k193264-disposable-high-speed-air-turbine-fda-510k.jpg K193264 - Disposable High Speed Air Turbine Handpiece K193264 is a FDA 510(k) cleared dental medical device. Manufacturer: Ningbo Hpdove Dental Instruments Co., Ltd.. Cleared Aug 2020. https://www.510kdatabase.net/k200359/ 2020-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k200359-nuera-tight-nuera-tight-ems-fda-510k.jpg K200359 - NuEra Tight, NuEra Tight EMS K200359 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bios S.R.L.. Cleared Aug 2020. https://www.510kdatabase.net/k200740/ 2020-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k200740-hd-video-rhino-laryngoscope-fda-510k.jpg K200740 - HD Video Rhino Laryngoscope K200740 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k200981/ 2020-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k200981-mega-plus-mis-spine-system-fda-510k.jpg K200981 - Mega Plus MIS Spine System K200981 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Bk Meditech, Co., Ltd.. Cleared Aug 2020. https://www.510kdatabase.net/k201286/ 2020-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k201286-09-sodium-chloride-iv-flush-syringe-fda-510k.jpg K201286 - 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 1 syringe/pouch, 0.9% Sodium Chloride I.V. Flush Syringe for Sterile Delivery, 2 syringes/pouch K201286 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Nurse Assist, LLC. Cleared Aug 2020. https://www.510kdatabase.net/k201588/ 2020-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k201588-cryocare-touch-system-and-accessories-fda-510k.jpg K201588 - CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice K201588 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k201623/ 2020-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k201623-lion-photocoagulator-fda-510k.jpg K201623 - LION Photocoagulator K201623 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Norlase Aps. Cleared Aug 2020. https://www.510kdatabase.net/k201722/ 2020-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k201722-hyperfine-point-of-care-magnetic-fda-510k.jpg K201722 - Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System K201722 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hyperfine Research, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k201933/ 2020-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k201933-imagenspect-30-fda-510k.jpg K201933 - ImagenSPECT 3.0 K201933 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cardiovascular Imaging Technologies. Cleared Aug 2020. https://www.510kdatabase.net/k201953/ 2020-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k201953-omni-plus-surgical-system-fda-510k.jpg K201953 - OMNI PLUS Surgical System K201953 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Sight Sciences, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k192551/ 2020-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k192551-1ml-luer-slip-or-luer-lock-syringe-fda-510k.jpg K192551 - 1ml Luer Slip or Luer Lock Syringe, Syringe with permanently attached needle, Safety Syringe with permanently attached needle K192551 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Caina Medical Co.,Ltd. Cleared Aug 2020. https://www.510kdatabase.net/k193626/ 2020-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k193626-masimo-rad-97-pulse-co-oximeter-and-fda-510k.jpg K193626 - Masimo Rad-97 Pulse CO-Oximeter and Accessories K193626 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Masimo Corporation. Cleared Aug 2020. https://www.510kdatabase.net/k200592/ 2020-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k200592-gs-medical-anyplus-peek-cage-system-fda-510k.jpg K200592 - GS Medical AnyPlus PEEK Cage System K200592 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: GS Medical Co., Ltd.. Cleared Aug 2020. https://www.510kdatabase.net/k201567/ 2020-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k201567-precice-bone-transport-system-fda-510k.jpg K201567 - Precice® Bone Transport System K201567 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nuvasive Specialized Orthopedics, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k201585/ 2020-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k201585-monterey-al-interbody-system-fda-510k.jpg K201585 - Monterey AL Interbody System K201585 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Corporation. Cleared Aug 2020. https://www.510kdatabase.net/k193006/ 2020-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k193006-magventure-tms-therapy-for-treatment-fda-510k.jpg K193006 - MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system K193006 is a FDA 510(k) cleared neurology medical device. Manufacturer: Tonica Elektronik A/S. Cleared Aug 2020. https://www.510kdatabase.net/k192075/ 2020-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k192075-proseal-closed-system-drug-transfer-fda-510k.jpg K192075 - ProSeal™ Closed System drug Transfer Device (CSTD) K192075 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Epic Medical Pte. , Ltd.. Cleared Aug 2020. https://www.510kdatabase.net/k192657/ 2020-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k192657-sterile-high-pressure-angiographic-fda-510k.jpg K192657 - Sterile High-pressure Angiographic Syringes for Single-use K192657 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen Boon Medical Supply Co., Ltd.. Cleared Aug 2020. https://www.510kdatabase.net/k193082/ 2020-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k193082-fountain-valvetip-infusion-catheter-fda-510k.jpg K193082 - Fountain ValveTip Infusion Catheter K193082 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k193130/ 2020-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k193130-mvp-aligner-system-fda-510k.jpg K193130 - MVP Aligner System K193130 is a FDA 510(k) cleared dental medical device. Manufacturer: Mvp Aligners, LLC. Cleared Aug 2020. https://www.510kdatabase.net/k193207/ 2020-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k193207-taichia-fda-510k.jpg K193207 - TaiChiA K193207 is a FDA 510(k) cleared radiology medical device. Manufacturer: Our United Corporation. Cleared Aug 2020. https://www.510kdatabase.net/k193278/ 2020-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k193278-medsource-cathmed-iv-catheter-fda-510k.jpg K193278 - MedSource CathMED IV Catheter K193278 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medsource Labs. Cleared Aug 2020. https://www.510kdatabase.net/k200809/ 2020-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k200809-d-lux-fda-510k.jpg K200809 - D-LUX+ K200809 is a FDA 510(k) cleared dental medical device. Manufacturer: DiaDent Group International. Cleared Aug 2020. https://www.510kdatabase.net/k200990/ 2020-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k200990-vidavision-fda-510k.jpg K200990 - VIDAvision K200990 is a FDA 510(k) cleared radiology medical device. Manufacturer: Vida Diagnostics, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k201006/ 2020-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k201006-k2m-navigation-instruments-fda-510k.jpg K201006 - K2M Navigation Instruments K201006 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: K2m, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k201067/ 2020-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k201067-cupid-brand-male-natural-rubber-latex-fda-510k.jpg K201067 - CUPID Brand Male Natural Rubber Latex Condoms (Plain (banana) , Plain (strawberry), Dotted , Multi-textured (Dotted+Contoured + Ribbed)) K201067 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Cupid Limited. Cleared Aug 2020. https://www.510kdatabase.net/k201244/ 2020-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k201244-concorde-models-concorde-us-and-fda-510k.jpg K201244 - Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices K201244 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Transmed7, LLC. Cleared Aug 2020. https://www.510kdatabase.net/k201310/ 2020-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k201310-accipiolx-fda-510k.jpg K201310 - Accipiolx K201310 is a FDA 510(k) cleared radiology medical device. Manufacturer: Maxq-Al , Ltd.. Cleared Aug 2020. https://www.510kdatabase.net/k201619/ 2020-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k201619-endotool-iv-system-fda-510k.jpg K201619 - EndoTool IV System K201619 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Monarch Medical Technologies, LLC. Cleared Aug 2020. https://www.510kdatabase.net/k201883/ 2020-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k201883-65-mm-healix-advance-sp-peek-anchor-65-fda-510k.jpg K201883 - 6.5 mm Healix Advance SP Peek Anchor, 6.5 mm Healix Advance SP Biocomposite Anchor K201883 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International SARL. Cleared Aug 2020. https://www.510kdatabase.net/k201926/ 2020-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k201926-carboclear-pedicle-screw-system-fda-510k.jpg K201926 - CarboClear® Pedicle Screw System, CarboClear® II Pedicle Screw System K201926 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: CarboFix Orthopedics , Ltd.. Cleared Aug 2020. https://www.510kdatabase.net/k201932/ 2020-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k201932-x-ray-flat-panel-detectors-careview-fda-510k.jpg K201932 - X-ray Flat Panel Detectors (CareView 1800Cwe /CareView 1500Cwe) K201932 is a FDA 510(k) cleared radiology medical device. Manufacturer: Careray Digital Medical System Co., Ltd.. Cleared Aug 2020. https://www.510kdatabase.net/k201938/ 2020-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k201938-lzi-fentanyl-ii-enzyme-immunoassay-fda-510k.jpg K201938 - LZI Fentanyl II Enzyme Immunoassay K201938 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Lin-Zhi International, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/den200001/ 2020-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/den200001-cell-free-dna-bct-fda-510k.jpg DEN200001 - Cell-Free DNA BCT DEN200001 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Streck, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k191644/ 2020-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k191644-tk-safety-needle-fda-510k.jpg K191644 - TK Safety Needle K191644 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Anhui Tiankang Medical Technology Co., Ltd.. Cleared Aug 2020. https://www.510kdatabase.net/k193066/ 2020-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k193066-steripack-cases-and-tray-systems-fda-510k.jpg K193066 - Steripack cases and Tray Systems K193066 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Avalign Technologies, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k200324/ 2020-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k200324-nhancer-rx-fda-510k.jpg K200324 - NHancer Rx K200324 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Imds Operations B.V.. Cleared Aug 2020. https://www.510kdatabase.net/k200353/ 2020-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k200353-manaflow-fda-510k.jpg K200353 - ManaFlow K200353 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Manamed, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k200858/ 2020-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k200858-mini-sterilizable-tray-fda-510k.jpg K200858 - Mini Sterilizable Tray K200858 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Implant Direct Sybron Manufacturing, LLC. Cleared Aug 2020. https://www.510kdatabase.net/k200890/ 2020-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k200890-invacare-perfecto2v-oxygen-concentrator-fda-510k.jpg K200890 - Invacare Perfecto2V Oxygen Concentrator K200890 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Invacare Corporation. Cleared Aug 2020. https://www.510kdatabase.net/k201076/ 2020-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k201076-anchor-dual-lumen-guidewire-catheter-fda-510k.jpg K201076 - Anchor Dual Lumen Guidewire Catheter K201076 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aqure Medical, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k201143/ 2020-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k201143-vicryl-mesh-fda-510k.jpg K201143 - VICRYL Mesh K201143 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k201502/ 2020-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k201502-vitra-810-fda-510k.jpg K201502 - Vitra 810 K201502 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Quantel Medical. Cleared Aug 2020. https://www.510kdatabase.net/k201521/ 2020-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k201521-medina-anterior-cervical-plate-system-fda-510k.jpg K201521 - Medina Anterior Cervical Plate System K201521 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alliance Partners, LLC. Cleared Aug 2020. https://www.510kdatabase.net/k201641/ 2020-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k201641-disposable-laparoscope-trocar-fda-510k.jpg K201641 - Disposable Laparoscope Trocar K201641 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Beijing Biosis Healing Biolog Ical Technology Co., Ltd.. Cleared Aug 2020. https://www.510kdatabase.net/k201667/ 2020-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k201667-midmark-extraoral-imaging-system-eois-fda-510k.jpg K201667 - Midmark Extraoral Imaging System (EOIS) K201667 is a FDA 510(k) cleared radiology medical device. Manufacturer: Midmark Corporation. Cleared Aug 2020. https://www.510kdatabase.net/k201750/ 2020-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k201750-pentaray-nav-eco-high-density-mapping-fda-510k.jpg K201750 - Pentaray Nav eco High-Density Mapping Catheter K201750 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biosense Webster, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k201907/ 2020-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k201907-clarivein-ic-fda-510k.jpg K201907 - ClariVein IC K201907 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k190580/ 2020-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k190580-nadia-si-fusion-system-fda-510k.jpg K190580 - NADIA SI Fusion System K190580 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ilion Medical, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k191955/ 2020-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k191955-enhanced-external-counter-pulsation-fda-510k.jpg K191955 - Enhanced External Counter Pulsation Device Plus Omay-A K191955 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Omay(Guangzhou)Med Technologies Co., Ltd.. Cleared Aug 2020. https://www.510kdatabase.net/k192883/ 2020-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k192883-spartan-hip-stem-fda-510k.jpg K192883 - Spartan Hip Stem K192883 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Signature Orthopaedics Pty, Ltd.. Cleared Aug 2020. https://www.510kdatabase.net/k193247/ 2020-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k193247-latitude-ev-total-elbow-arthroplasty-fda-510k.jpg K193247 - LATITUDE EV™ Total Elbow Arthroplasty K193247 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tornier, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k200009/ 2020-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k200009-adaptive-biotechnologies-clonoseq-assay-fda-510k.jpg K200009 - Adaptive Biotechnologies clonoSEQ Assay K200009 is a FDA 510(k) cleared medical genetics medical device. Manufacturer: Adaptive Biotechnologies Corporation. Cleared Aug 2020. https://www.510kdatabase.net/k200351/ 2020-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k200351-plasmaflight-fda-510k.jpg K200351 - PlasmaFlight K200351 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Manamed, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k200780/ 2020-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k200780-xbit-series-digital-color-doppler-fda-510k.jpg K200780 - XBit Series Digital Color Doppler Ultrasound System K200780 is a FDA 510(k) cleared radiology medical device. Manufacturer: CHISON Medical Technologies Co., Ltd.. Cleared Aug 2020. https://www.510kdatabase.net/k200977/ 2020-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k200977-modular-toga-fda-510k.jpg K200977 - Modular Toga K200977 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Operating Room Innovations, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k201079/ 2020-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k201079-aurora-anterior-lumbar-plate-sytstem-fda-510k.jpg K201079 - Aurora® Anterior Lumbar Plate Sytstem K201079 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Prism Surgical Design Pty , Ltd.. Cleared Aug 2020. https://www.510kdatabase.net/k201240/ 2020-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k201240-mariner-cap-system-fda-510k.jpg K201240 - Mariner Cap System K201240 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared Aug 2020. https://www.510kdatabase.net/k201251/ 2020-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k201251-carboclear-navigated-instruments-fda-510k.jpg K201251 - CarboClear Navigated Instruments K201251 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: CarboFix Orthopedics , Ltd.. Cleared Aug 2020. https://www.510kdatabase.net/k201530/ 2020-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k201530-nitrile-powder-free-examination-glove-fda-510k.jpg K201530 - Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Fusion Dark Grey) K201530 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hartalega NGC Sdn. Bhd.. Cleared Aug 2020. https://www.510kdatabase.net/k201531/ 2020-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k201531-sterile-nitrile-powder-free-fda-510k.jpg K201531 - Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) K201531 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hartalega Sdn Bhd. Cleared Aug 2020. https://www.510kdatabase.net/k201715/ 2020-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k201715-smart-toe-ii-x-fuse-fda-510k.jpg K201715 - Smart Toe II, X Fuse K201715 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker GmbH. Cleared Aug 2020. https://www.510kdatabase.net/k201952/ 2020-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k201952-crossglide-ets-plus-fda-510k.jpg K201952 - CrossGlide ETS Plus K201952 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Crossbay Medical. Cleared Aug 2020. https://www.510kdatabase.net/k191670/ 2020-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k191670-cureos-tcp-fda-510k.jpg K191670 - CureOs TCP K191670 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Linacol Muh Dan Kim Cev Tek Med Ith Ihr San VE Tic. Cleared Aug 2020. https://www.510kdatabase.net/k193210/ 2020-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k193210-hyper-dlr-fda-510k.jpg K193210 - HYPER DLR K193210 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Aug 2020. https://www.510kdatabase.net/k193545/ 2020-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k193545-corin-optimized-positioning-system-ops-fda-510k.jpg K193545 - Corin Optimized Positioning System (OPS) Femoral K193545 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corin USA. Cleared Aug 2020. https://www.510kdatabase.net/k193666/ 2020-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k193666-powder-free-blue-nitrile-examination-fda-510k.jpg K193666 - Powder-Free Blue Nitrile Examination Gloves (Tested for use with Chemotherapy and Fentanyl) – Regular Cuff K193666 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k201168/ 2020-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k201168-ecg-monitor-app-fda-510k.jpg K201168 - ECG Monitor App K201168 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Samsung Electronics Co., Ltd.. Cleared Aug 2020. https://www.510kdatabase.net/k201217/ 2020-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k201217-hemocue-hb-301-system-fda-510k.jpg K201217 - HemoCue Hb 301 System K201217 is a FDA 510(k) cleared hematology medical device. Manufacturer: Hemocue AB. Cleared Aug 2020. https://www.510kdatabase.net/k201500/ 2020-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k201500-life-spine-plateau-a-ti-anterior-fda-510k.jpg K201500 - Life Spine Plateau-A Ti Anterior Lumbar Spacer & Plateau-X Ti Lateral Lumbar Spacer K201500 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k201704/ 2020-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k201704-cofix-system-fda-510k.jpg K201704 - CoFix System K201704 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paradigm Spine GmbH. Cleared Aug 2020. https://www.510kdatabase.net/k201850/ 2020-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k201850-vector-hammertoe-correction-system-fda-510k.jpg K201850 - Vector Hammertoe Correction System K201850 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nvision Biomedical Technologies, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k201958/ 2020-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k201958-etd-family-of-electrotherapy-devices-fda-510k.jpg K201958 - ETD Family of Electrotherapy Devices K201958 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Therasigma, LLC. Cleared Aug 2020. https://www.510kdatabase.net/k192712/ 2020-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k192712-attain-select-ii-surevalve-delivery-fda-510k.jpg K192712 - Attain Select II + SureValve delivery catheter system, Attain Command + SureValve Left Heart Delivery System, Attain Comman + SureValve Guide Catheters for Left Heart Delivery, C315 Delivery Catheter K192712 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k192991/ 2020-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k192991-vesco-medical-extension-feeding-set-fda-510k.jpg K192991 - Vesco Medical Extension Feeding Set K192991 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Vesco Medical, LLC. Cleared Aug 2020. https://www.510kdatabase.net/k193355/ 2020-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k193355-electrodes-handpieces-for-mygen-v-1000-fda-510k.jpg K193355 - Electrodes Handpieces for Mygen V-1000 RF System K193355 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: RF Medical Co., Ltd.. Cleared Aug 2020. https://www.510kdatabase.net/k200649/ 2020-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k200649-arm-type-fully-automatic-digital-blood-fda-510k.jpg K200649 - Arm-Type Fully Automatic Digital Blood Pressure Monitor K200649 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Joytech Healthcare Co. , Ltd.. Cleared Aug 2020. https://www.510kdatabase.net/k200667/ 2020-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k200667-eyeart-fda-510k.jpg K200667 - EyeArt K200667 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Eyenuk, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k200954/ 2020-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k200954-glaucoma-module-fda-510k.jpg K200954 - Glaucoma Module K200954 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Topcon Healthcare Solutions, Inc.. Cleared Aug 2020. https://www.510kdatabase.net/k190790/ 2020-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k190790-flex-fit-fda-510k.jpg K190790 - Flex Fit K190790 is a FDA 510(k) cleared dental medical device. Manufacturer: Dk Mungyo Corporation. Cleared Jul 2020. https://www.510kdatabase.net/k191101/ 2020-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k191101-kendall-npwt-incision-management-fda-510k.jpg K191101 - Kendall NPWT Incision Management Dressing Kit K191101 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cardinalhealth. Cleared Jul 2020. https://www.510kdatabase.net/k192294/ 2020-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k192294-i-do-fda-510k.jpg K192294 - I Do K192294 is a FDA 510(k) cleared dental medical device. Manufacturer: I DO Biotech Co., Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k192499/ 2020-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k192499-cyber-blade-fda-510k.jpg K192499 - Cyber Blade K192499 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: SIDAM S.r.l.. Cleared Jul 2020. https://www.510kdatabase.net/k193237/ 2020-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k193237-carto-octaray-mapping-catheter-with-fda-510k.jpg K193237 - Carto Octaray Mapping Catheter with Trueref Technology K193237 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biosense Webster, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k200039/ 2020-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k200039-p-pro-crown-bridge-fda-510k.jpg K200039 - P pro Crown & Bridge K200039 is a FDA 510(k) cleared dental medical device. Manufacturer: Deltamed GmbH. Cleared Jul 2020. https://www.510kdatabase.net/k200584/ 2020-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k200584-xport-304-micor-system-lens-fda-510k.jpg K200584 - xPORT 304 (miCOR) System Lens Fragmentation System K200584 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Carl Zeiss Meditec Cataract Technology, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k200791/ 2020-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k200791-navigation-enabled-intruments-fda-510k.jpg K200791 - Navigation Enabled Intruments K200791 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International SARL. Cleared Jul 2020. https://www.510kdatabase.net/k200803/ 2020-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k200803-bear-and-bear-mini-fda-510k.jpg K200803 - BEAR and BEAR mini K200803 is a FDA 510(k) cleared neurology medical device. Manufacturer: Foreo, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k201069/ 2020-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k201069-vibrantvue-scleral-saline-fda-510k.jpg K201069 - VibrantVue Scleral Saline K201069 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Dry Eye Innovations, LLC. Cleared Jul 2020. https://www.510kdatabase.net/k201087/ 2020-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k201087-corbel-spacers-fda-510k.jpg K201087 - CORBEL Spacers K201087 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k201442/ 2020-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k201442-lin-zhi-international-inc-lzi-fda-510k.jpg K201442 - Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus Analyzers K201442 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diatron Group. Cleared Jul 2020. https://www.510kdatabase.net/k201511/ 2020-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k201511-reprocessed-endoscopic-trocars-and-fda-510k.jpg K201511 - Reprocessed Endoscopic Trocars and Sleeves K201511 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker Sustainability Solutions. Cleared Jul 2020. https://www.510kdatabase.net/k201597/ 2020-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k201597-liver-incytes-model-1005-fda-510k.jpg K201597 - Liver Incytes, Model 1005 K201597 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sonic Incytes. Cleared Jul 2020. https://www.510kdatabase.net/k201833/ 2020-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k201833-bipad-hand-activated-disposable-fda-510k.jpg K201833 - BiPad Hand Activated, Disposable Bipolar Electrocautery Cords K201833 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bipad Surgical, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k201837/ 2020-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k201837-urolift-2-system-formerly-ul500-fda-510k.jpg K201837 - UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge K201837 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Neotract, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k201898/ 2020-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k201898-clear-guide-scenergy-fda-510k.jpg K201898 - Clear Guide SCENERGY K201898 is a FDA 510(k) cleared radiology medical device. Manufacturer: Clear Guide Medical. Cleared Jul 2020. https://www.510kdatabase.net/k201951/ 2020-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k201951-cemented-origin-hip-stem-fda-510k.jpg K201951 - Cemented Origin Hip Stem K201951 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Signature Orthopaedics Pty, Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k192663/ 2020-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k192663-joimax-intracs-system-fda-510k.jpg K192663 - Joimax Intracs System K192663 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Joimax GmbH. Cleared Jul 2020. https://www.510kdatabase.net/k193283/ 2020-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k193283-ai-rad-companion-prostate-mr-fda-510k.jpg K193283 - AI-Rad Companion Prostate MR K193283 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k193321/ 2020-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k193321-my01-continuous-compartmental-pressure-fda-510k.jpg K193321 - MY01 Continuous Compartmental Pressure Monitor K193321 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: MY01, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k193417/ 2020-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k193417-fracturedetect-fx-fda-510k.jpg K193417 - FractureDetect (FX) K193417 is a FDA 510(k) cleared radiology medical device. Manufacturer: Imagen Technologies, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k193660/ 2020-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k193660-ossiofiber-compression-screws-fda-510k.jpg K193660 - OSSIOfiber™ Compression Screws K193660 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OSSIO , Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k200060/ 2020-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k200060-reprocessed-nrg-transseptal-needle-fda-510k.jpg K200060 - Reprocessed NRG Transseptal Needle K200060 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Innovative Health, LLC. Cleared Jul 2020. https://www.510kdatabase.net/k200082/ 2020-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k200082-bd-univia-rightfit-enteral-extension-fda-510k.jpg K200082 - BD Univia RightFit Enteral Extension Sets and Transitional Adapters K200082 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Mps Medical, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k200142/ 2020-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k200142-speedicath-soft-fda-510k.jpg K200142 - SpeediCath Soft K200142 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Coloplast. Cleared Jul 2020. https://www.510kdatabase.net/k200280/ 2020-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k200280-medrad-imaging-bulk-package-transfer-fda-510k.jpg K200280 - MEDRAD Imaging Bulk Package Transfer Spike K200280 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bayer Medical Care, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k200678/ 2020-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k200678-pentax-medical-video-bronchoscope-eb-fda-510k.jpg K200678 - PENTAX Medical Video Bronchoscope EB-J10 Series K200678 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Pentax of America, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k200832/ 2020-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k200832-safey-peak-flow-meter-fda-510k.jpg K200832 - Safey Peak Flow Meter K200832 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Safey Medical Devices Pvt, Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k201002/ 2020-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k201002-safey-pocket-spirometer-fda-510k.jpg K201002 - Safey Pocket Spirometer K201002 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Safey Medical Devices Pvt, Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k201059/ 2020-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k201059-s60-elite-seriess70-series-digital-fda-510k.jpg K201059 - S60 Elite Series/S70 Series Digital Color Doppler Ultrasound System K201059 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sonoscape Medical Corp.. Cleared Jul 2020. https://www.510kdatabase.net/k201186/ 2020-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k201186-ky-grosz-jelly-fda-510k.jpg K201186 - KY Grosz Jelly K201186 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Rb Health (Us), LLC. Cleared Jul 2020. https://www.510kdatabase.net/k201543/ 2020-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k201543-magec-system-fda-510k.jpg K201543 - MAGEC® System K201543 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nuvasive Specialized Orthopedics, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k201648/ 2020-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k201648-sterispine-ps-fda-510k.jpg K201648 - Sterispine™ PS K201648 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Safe Orthopaedics. Cleared Jul 2020. https://www.510kdatabase.net/k201786/ 2020-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k201786-arthrex-mini-hip-pushlock-fda-510k.jpg K201786 - Arthrex Mini Hip PushLock K201786 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k201834/ 2020-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k201834-hi-torque-proceed-guide-wire-family-fda-510k.jpg K201834 - HI-TORQUE PROCEED Guide Wire Family K201834 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Vascular. Cleared Jul 2020. https://www.510kdatabase.net/k201851/ 2020-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k201851-exult-femoral-component-trial-left-fda-510k.jpg K201851 - EXULT Femoral component trial - Left, EXULT Femoral component trial - Right K201851 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corentec Co., Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/den200015/ 2020-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/den200015-cobas-ebv-cobas-ebvbkv-control-kit-fda-510k.jpg DEN200015 - cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit DEN200015 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Molecular Systems, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k182759/ 2020-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k182759-boniplus-dental-g-mesh-system-fda-510k.jpg K182759 - BoniPlus Dental G-Mesh System K182759 is a FDA 510(k) cleared dental medical device. Manufacturer: Montjade Engineering Co., Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k193647/ 2020-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k193647-superpipe-angiographic-catheter-fda-510k.jpg K193647 - Superpipe Angiographic Catheter K193647 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Suzhou Hengrui Disheng Medical Co., Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k200413/ 2020-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k200413-symphony-fda-510k.jpg K200413 - Symphony K200413 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aroa Biosurgery , Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k200504/ 2020-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k200504-bonebridge-system-samba-2-bb-symfit-80-fda-510k.jpg K200504 - BONEBRIDGE System, SAMBA 2 BB, SYMFIT 8.0, SAMBA 2 GO, SAMBA 2 Remote K200504 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Med-El Elektromedizinische Geraete GmbH. Cleared Jul 2020. https://www.510kdatabase.net/k200518/ 2020-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k200518-pitkar-external-fixation-system-rail-fda-510k.jpg K200518 - Pitkar External Fixation System - Rail Mechanism K200518 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: S.H.Pitkar Orthotools Pvt. , Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k200824/ 2020-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k200824-cardinal-health-smartgown-breathable-fda-510k.jpg K200824 - Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown K200824 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cardinal Health200, LLC. Cleared Jul 2020. https://www.510kdatabase.net/k200959/ 2020-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k200959-biolox-delta-ceramic-heads-biolox-fda-510k.jpg K200959 - Biolox® delta Ceramic Heads, Biolox® delta Option Ceramic Heads MR Labeling K200959 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet UK, Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k201040/ 2020-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k201040-bioflux-software-ii-fda-510k.jpg K201040 - Bioflux Software II K201040 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biotricity. Cleared Jul 2020. https://www.510kdatabase.net/k201361/ 2020-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k201361-pneumoclear-fda-510k.jpg K201361 - PNEUMOCLEAR K201361 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: W.O.M. World of Medicine GmbH. Cleared Jul 2020. https://www.510kdatabase.net/k201760/ 2020-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k201760-zoom-14-guidewire-fda-510k.jpg K201760 - Zoom 14 Guidewire K201760 is a FDA 510(k) cleared neurology medical device. Manufacturer: Scientia Vascular, LLC. Cleared Jul 2020. https://www.510kdatabase.net/k192481/ 2020-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k192481-accelfix-lumbar-plate-system-fda-510k.jpg K192481 - AccelFix Lumbar Plate System K192481 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: L & K Biomed Co., Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k192681/ 2020-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k192681-safety-scalp-vein-set-scalp-vein-set-fda-510k.jpg K192681 - Safety scalp vein set, Scalp vein set, Blood collection needle (Scalp vein set type), Blood collection needle (Needle holder type), Safety blood collection needle (Scalp vein set type), Safety blood collection needle (Needle holder type) K192681 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Kangbao Medical Equipment Co., Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k200801/ 2020-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k200801-quantisal-oral-fluid-collection-device-fda-510k.jpg K200801 - Quantisal Oral Fluid Collection Device K200801 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Immunalysis Corporation. Cleared Jul 2020. https://www.510kdatabase.net/k200805/ 2020-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k200805-neocis-guidance-system-ngs-with-fda-510k.jpg K200805 - Neocis Guidance System (NGS) with Patient Splints K200805 is a FDA 510(k) cleared dental medical device. Manufacturer: Neocis, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k201434/ 2020-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k201434-connected-or-hub-with-voice-control-fda-510k.jpg K201434 - Connected OR Hub with Voice Control, Connected OR Hub with Device Control K201434 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker. Cleared Jul 2020. https://www.510kdatabase.net/k201616/ 2020-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k201616-symri-fda-510k.jpg K201616 - SyMRI K201616 is a FDA 510(k) cleared radiology medical device. Manufacturer: Syntheticmr AB. Cleared Jul 2020. https://www.510kdatabase.net/k201792/ 2020-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k201792-truselect-microcatheter-fda-510k.jpg K201792 - TRUSELECT Microcatheter K201792 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Jul 2020. https://www.510kdatabase.net/k201794/ 2020-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k201794-jade-fda-510k.jpg K201794 - Jade K201794 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: OrbusNeich Medical (Shenzhen) Co., Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k200242/ 2020-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k200242-staclear-syringe-fda-510k.jpg K200242 - StaClear Syringe K200242 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Tribofilm Research, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k200550/ 2020-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k200550-vitalograph-model-2120-in2itive-ediary-fda-510k.jpg K200550 - Vitalograph Model 2120 In2itive eDiary K200550 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Vitalograph (Ireland) , Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k200785/ 2020-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k200785-stratum-reduced-size-foot-plating-system-fda-510k.jpg K200785 - Stratum™ Reduced Size Foot Plating System K200785 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nextremity Solutions, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k201132/ 2020-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k201132-arthrex-compression-screws-fda-510k.jpg K201132 - Arthrex Compression Screws K201132 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k201280/ 2020-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k201280-ethicon-circular-stapler-ethicon-fda-510k.jpg K201280 - Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed K201280 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon Endo-Surgery, LLC. Cleared Jul 2020. https://www.510kdatabase.net/k192669/ 2020-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k192669-extremely-thin-003-zero-zero-three-fda-510k.jpg K192669 - Extremely Thin 003, ZERO ZERO THREE K192669 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Okamoto USA, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k193575/ 2020-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k193575-arthrex-suturetape-fda-510k.jpg K193575 - Arthrex SutureTape K193575 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Arthrex, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k193601/ 2020-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k193601-single-use-electrosurgical-knife-fda-510k.jpg K193601 - Single Use Electrosurgical Knife K193601 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Micro-Tech (Nanjing) Co., Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k193625/ 2020-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k193625-disposable-temperature-probe-fda-510k.jpg K193625 - Disposable Temperature Probe K193625 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen Changke Connect Electronics Co., Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k200496/ 2020-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k200496-aer-x-fda-510k.jpg K200496 - Aer X K200496 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: 3B Medical, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k200643/ 2020-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k200643-hepatus-7hepatus-6hepatus-5hepatus-fda-510k.jpg K200643 - Hepatus 7/Hepatus 6/Hepatus 5/Hepatus 7S/Hepatus 6S/Hepatus 5S/Hepatus 7T/Hepatus 6T/Hepatus 5T/Fibrous 7/Fibrous K200643 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k200742/ 2020-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k200742-jusha-cp610-lcd-monitor-fda-510k.jpg K200742 - JUSHA-CP610 LCD Monitor K200742 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nanjing Jusha Display Technology Co., Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k200849/ 2020-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k200849-tempus-ls-manual-fda-510k.jpg K200849 - Tempus LS - Manual K200849 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Remote Diagnostic Technologies, Ltd. A Philips Company. Cleared Jul 2020. https://www.510kdatabase.net/k200927/ 2020-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k200927-transept-cervical-plate-system-fda-510k.jpg K200927 - Transept Cervical Plate System K200927 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Neurostructures, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k201293/ 2020-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k201293-ureterorenoscope-system-fda-510k.jpg K201293 - Ureterorenoscope System K201293 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Shanghai AnQing Medical Instrument Co., Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k201321/ 2020-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k201321-depuy-synthes-27mm-va-lcp-clavicle-fda-510k.jpg K201321 - DePuy Synthes 2.7mm VA LCP Clavicle Plate System K201321 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Synthes. Cleared Jul 2020. https://www.510kdatabase.net/k201479/ 2020-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k201479-dememask-fda-510k.jpg K201479 - DemeMASK K201479 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Demetech Corporation. Cleared Jul 2020. https://www.510kdatabase.net/k193450/ 2020-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k193450-pre-seed-fertility-lubricant-fda-510k.jpg K193450 - Pre-Seed™ Fertility Lubricant K193450 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Church & Dwight Co., Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k193520/ 2020-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k193520-eva-15-insufflator-fda-510k.jpg K193520 - EVA 15 Insufflator K193520 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Palliare , Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k200090/ 2020-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k200090-pentax-medical-eg-j10u-endoscopic-fda-510k.jpg K200090 - PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type), EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type), EG38-J10UT Ultrasound Upper GI Video Scope (Convex Array Type) K200090 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Pentax of America, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k200464/ 2020-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k200464-lg-pra-l-derma-ld-scalp-care-fda-510k.jpg K200464 - LG Pra. L Derma LD Scalp Care K200464 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lg Electronics.Inc. Cleared Jul 2020. https://www.510kdatabase.net/k200738/ 2020-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k200738-microlife-upper-arm-automatic-digital-fda-510k.jpg K200738 - Microlife Upper Arm Automatic Digital Blood Pressure Monitor K200738 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Microlife Intellectual Property GmbH. Cleared Jul 2020. https://www.510kdatabase.net/k200743/ 2020-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k200743-vivid-e80-vivid-e90-vivid-e95-fda-510k.jpg K200743 - Vivid E80/ Vivid E90/ Vivid E95 K200743 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems Ultrasound And. Cleared Jul 2020. https://www.510kdatabase.net/k201083/ 2020-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k201083-parcus-v-lox-titanium-suture-anchors-fda-510k.jpg K201083 - Parcus V-lox Titanium Suture Anchors, Parcus Miti Suture Anchors K201083 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Parcus Medical, LLC. Cleared Jul 2020. https://www.510kdatabase.net/k201122/ 2020-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k201122-canon-non-mydriatic-retinal-camera-cr-fda-510k.jpg K201122 - Canon non-mydriatic retinal camera CR series K201122 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Canon, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k201713/ 2020-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k201713-avvigo-guidance-system-fda-510k.jpg K201713 - AVVIGO Guidance System K201713 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Jul 2020. https://www.510kdatabase.net/k201796/ 2020-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k201796-1717scv-1717sgv-fda-510k.jpg K201796 - 1717SCV, 1717SGV K201796 is a FDA 510(k) cleared radiology medical device. Manufacturer: Rayence Co., Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k192511/ 2020-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k192511-venner-pneux-tt-tracheostomy-tube-size-fda-510k.jpg K192511 - Venner PneuX™ TT (Tracheostomy Tube) Size 7.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 8.0 mm, Venner PneuX™ TT (Tracheostomy Tube) Size 9.0 mm K192511 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Venner Medical (Singapore) Pte, Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k192998/ 2020-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k192998-reprocessed-brk-transseptal-needle-fda-510k.jpg K192998 - Reprocessed BRK Transseptal Needle K192998 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Innovative Health, LLC. Cleared Jul 2020. https://www.510kdatabase.net/k193277/ 2020-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k193277-somatom-onsite-and-onscene-fda-510k.jpg K193277 - SOMATOM On.site and On.scene K193277 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k193528/ 2020-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k193528-empty-eva-bag-fda-510k.jpg K193528 - Empty EVA Bag K193528 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Haemotronic S.P.A.. Cleared Jul 2020. https://www.510kdatabase.net/k200355/ 2020-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k200355-duranext-abutments-fda-510k.jpg K200355 - Duranext Abutments K200355 is a FDA 510(k) cleared dental medical device. Manufacturer: Elegant Dental Corp.. Cleared Jul 2020. https://www.510kdatabase.net/k200513/ 2020-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k200513-dac-dynamic-active-compression-plate-fda-510k.jpg K200513 - DAC Dynamic Active Compression Plate K200513 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Pioneer Surgical Technology, Inc., Dba Rti Surgical. Cleared Jul 2020. https://www.510kdatabase.net/k200621/ 2020-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k200621-caption-interpretation-automated-fda-510k.jpg K200621 - Caption Interpretation Automated Ejection Fraction Software K200621 is a FDA 510(k) cleared radiology medical device. Manufacturer: Caption Health. Cleared Jul 2020. https://www.510kdatabase.net/k200654/ 2020-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k200654-rubicon-sa-system-fda-510k.jpg K200654 - Rubicon SA System K200654 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Dymedix Diagnostics, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k200836/ 2020-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k200836-8ch-flex-suite-fda-510k.jpg K200836 - 8ch Flex Suite K200836 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen RF Tech Co., Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k200869/ 2020-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k200869-gamma3-system-fda-510k.jpg K200869 - Gamma3 System K200869 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Trauma GmbH. Cleared Jul 2020. https://www.510kdatabase.net/k201150/ 2020-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k201150-inmode-rf-multi-system-fda-510k.jpg K201150 - InMode RF Multi-System K201150 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Inmode , Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k201200/ 2020-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k201200-visera-elite-ii-video-system-center-fda-510k.jpg K201200 - Visera Elite II Video System Center K201200 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Jul 2020. https://www.510kdatabase.net/k201355/ 2020-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k201355-endomat-select-ibs-shaver-software-fda-510k.jpg K201355 - Endomat Select, IBS Shaver Software, License K201355 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Karl Storz SE & CO. KG. Cleared Jul 2020. https://www.510kdatabase.net/k201406/ 2020-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k201406-picowon-fda-510k.jpg K201406 - Picowon K201406 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wontech Co., Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k201527/ 2020-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k201527-evos-straight-proximal-humerus-7-15-fda-510k.jpg K201527 - EVOS Straight Proximal Humerus 7-15 hole Plates (137-225mm) K201527 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k201699/ 2020-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k201699-medline-renewal-reprocessed-nellcor-fda-510k.jpg K201699 - Medline ReNewal Reprocessed Nellcor OxiMax SpO2 Sensor K201699 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Surgical Instrument and Savings Inc (Dba Medline Renewal). Cleared Jul 2020. https://www.510kdatabase.net/k201751/ 2020-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k201751-pedicle-screw-system-fda-510k.jpg K201751 - Pedicle Screw System K201751 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Black Box Medical, LLC. Cleared Jul 2020. https://www.510kdatabase.net/k201780/ 2020-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k201780-true-tulip-system-true-mis-system-fda-510k.jpg K201780 - True Tulip System, True M.I.S. System K201780 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Innovative Surgical Designs, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k192847/ 2020-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k192847-autolign-fda-510k.jpg K192847 - AUTOLIGN K192847 is a FDA 510(k) cleared dental medical device. Manufacturer: Diorco Co., Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k193434/ 2020-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k193434-vita-lumex-ac-fda-510k.jpg K193434 - VITA LUMEX AC K193434 is a FDA 510(k) cleared dental medical device. Manufacturer: Vita Zahnfabrik GmbH H Rauter & CO. Cleared Jul 2020. https://www.510kdatabase.net/k193607/ 2020-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k193607-bobby-balloon-guide-catheter-fda-510k.jpg K193607 - BOBBY Balloon Guide Catheter K193607 is a FDA 510(k) cleared neurology medical device. Manufacturer: MicroVention, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k200383/ 2020-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k200383-wiggins-medical-surgical-instruments-fda-510k.jpg K200383 - Wiggins Medical Surgical Instruments K200383 is a FDA 510(k) cleared neurology medical device. Manufacturer: Wiggins Medical. Cleared Jul 2020. https://www.510kdatabase.net/k200387/ 2020-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k200387-ace-medical-surgical-instruments-fda-510k.jpg K200387 - Ace Medical Surgical Instruments K200387 is a FDA 510(k) cleared neurology medical device. Manufacturer: Ace Medical. Cleared Jul 2020. https://www.510kdatabase.net/k201689/ 2020-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k201689-riptide-aspiration-system-fda-510k.jpg K201689 - Riptide Aspiration System K201689 is a FDA 510(k) cleared neurology medical device. Manufacturer: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. Cleared Jul 2020. https://www.510kdatabase.net/k201690/ 2020-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k201690-mirage-hydrophilic-guidewire-fda-510k.jpg K201690 - Mirage Hydrophilic Guidewire K201690 is a FDA 510(k) cleared neurology medical device. Manufacturer: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. Cleared Jul 2020. https://www.510kdatabase.net/k191875/ 2020-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k191875-owgels-oxygen-concentrator-fda-510k.jpg K191875 - Owgels Oxygen Concentrator K191875 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Guangzhou Life Light Electronic Technology Co., Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k192366/ 2020-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k192366-intravascular-extension-sets-and-fda-510k.jpg K192366 - Intravascular Extension Sets and Accessories K192366 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corporation. Cleared Jul 2020. https://www.510kdatabase.net/k193022/ 2020-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k193022-retractable-safety-insulin-syringe-fda-510k.jpg K193022 - Retractable Safety Insulin Syringe K193022 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Caina Medical Co.,Ltd. Cleared Jul 2020. https://www.510kdatabase.net/k193380/ 2020-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k193380-cerenovus-large-bore-catheter-fda-510k.jpg K193380 - CERENOVUS Large Bore Catheter K193380 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k193392/ 2020-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k193392-biosicar-silicone-implant-fda-510k.jpg K193392 - BioSiCar Silicone Implant K193392 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Metalware Technology Corp.. Cleared Jul 2020. https://www.510kdatabase.net/k193603/ 2020-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k193603-benesta-medical-sterilization-tray-fda-510k.jpg K193603 - Benesta Medical Sterilization Tray K193603 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Caldera Medical, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k201179/ 2020-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k201179-ge-apexpro-ch-spo2-nellcor-cable-ge-fda-510k.jpg K201179 - GE ApexPro CH SpO2 - Nellcor Cable, GE ApexPro FH SpO2 - Nellcor Cable K201179 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Covidien, LLC. Cleared Jul 2020. https://www.510kdatabase.net/k201349/ 2020-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k201349-smithnephew-arthroscopes-fda-510k.jpg K201349 - Smith+Nephew Arthroscopes K201349 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew. Cleared Jul 2020. https://www.510kdatabase.net/k192793/ 2020-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k192793-evis-exera-iii-colonovideoscope-fda-510k.jpg K192793 - Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope Olympus PCF-H190TI, Evis Exera III Colonovideoscope Olympus PCF-HQ190L, Evis Exera III Colonovideoscope Olympus PCF-HQ190I K192793 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Jul 2020. https://www.510kdatabase.net/k193204/ 2020-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k193204-cryocheck-chromogenic-factor-viii-fda-510k.jpg K193204 - Cryocheck Chromogenic Factor VIII K193204 is a FDA 510(k) cleared hematology medical device. Manufacturer: Precision Biologic. Cleared Jul 2020. https://www.510kdatabase.net/k193526/ 2020-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k193526-syringe-with-safety-needle-safety-needle-fda-510k.jpg K193526 - Syringe with safety needle, Safety needle K193526 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Caina Medical Co.,Ltd. Cleared Jul 2020. https://www.510kdatabase.net/k200063/ 2020-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k200063-aeroeclipse-one-ban-fda-510k.jpg K200063 - AeroEclipse* ONE BAN K200063 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Trudell Medical International. Cleared Jul 2020. https://www.510kdatabase.net/k200498/ 2020-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k200498-scenaria-view-fda-510k.jpg K200498 - SCENARIA View K200498 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hitachi Healthcare Americas. Cleared Jul 2020. https://www.510kdatabase.net/k200542/ 2020-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k200542-visera-elite-ii-xenon-light-source-fda-510k.jpg K200542 - Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video System Center, HD 3CMOS Autoclavable Camera Head, HD 3CMOS Camera Head K200542 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Jul 2020. https://www.510kdatabase.net/k200680/ 2020-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k200680-synvitro-hyadase-fda-510k.jpg K200680 - Synvitro Hyadase K200680 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Origio A/S, A Coopersurgical Company. Cleared Jul 2020. https://www.510kdatabase.net/k200818/ 2020-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k200818-3dmax-mid-anatomical-mesh-fda-510k.jpg K200818 - 3DMax MID Anatomical Mesh K200818 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k201098/ 2020-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k201098-ambu-duodeno-system-fda-510k.jpg K201098 - Ambu Duodeno System K201098 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ambu Innovation GmbH. Cleared Jul 2020. https://www.510kdatabase.net/k201198/ 2020-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k201198-sn-laparoscopes-4ko-autoclavable-sn-fda-510k.jpg K201198 - S+N Laparoscopes, 4KO, Autoclavable, S+N Bariactric Laparoscopes, 4KO, Autoclavable K201198 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew. Cleared Jul 2020. https://www.510kdatabase.net/k201227/ 2020-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k201227-phantom-hindfoot-ttctc-nail-system-fda-510k.jpg K201227 - Phantom® Hindfoot TTC/TC Nail System K201227 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paragon 28, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k201364/ 2020-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k201364-link-trabeculink-femoral-cones-fda-510k.jpg K201364 - LINK TrabecuLink Femoral Cones K201364 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Waldemar Link GmbH & Co. KG. Cleared Jul 2020. https://www.510kdatabase.net/k201365/ 2020-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k201365-true-3d-viewer-fda-510k.jpg K201365 - True 3D Viewer K201365 is a FDA 510(k) cleared radiology medical device. Manufacturer: Echopixel, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k201465/ 2020-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k201465-surgical-planner-srp-brainstorm-fda-510k.jpg K201465 - SuRgical Planner (SRP) BrainStorm K201465 is a FDA 510(k) cleared radiology medical device. Manufacturer: Surgical Theater, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k201488/ 2020-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k201488-rover-fda-510k.jpg K201488 - Rover K201488 is a FDA 510(k) cleared radiology medical device. Manufacturer: Micro-X , Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k201672/ 2020-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k201672-signia-stapler-with-new-software-fda-510k.jpg K201672 - Signia Stapler (with new software) K201672 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien. Cleared Jul 2020. https://www.510kdatabase.net/k201798/ 2020-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k201798-myqa-ion-fda-510k.jpg K201798 - myQA iON K201798 is a FDA 510(k) cleared radiology medical device. Manufacturer: Iba Dosimetry GmbH. Cleared Jul 2020. https://www.510kdatabase.net/k191449/ 2020-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k191449-zca-all-poly-acetabular-cups-fda-510k.jpg K191449 - ZCA All-Poly Acetabular Cups K191449 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k191698/ 2020-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k191698-tin-coated-humeral-head-fda-510k.jpg K191698 - TiN Coated Humeral Head K191698 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Fx Shoulder USA, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k192386/ 2020-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k192386-kerastat-cream-fda-510k.jpg K192386 - KeraStat Cream K192386 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Keranetics. Cleared Jul 2020. https://www.510kdatabase.net/k193456/ 2020-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k193456-arm-blood-pressure-monitor-fda-510k.jpg K193456 - Arm Blood Pressure Monitor K193456 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ningbo Ranor Medical Science & Technology Co., Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k200497/ 2020-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k200497-vivid-s60n-vivid-s70n-fda-510k.jpg K200497 - Vivid S60N, Vivid S70N K200497 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared Jul 2020. https://www.510kdatabase.net/k200578/ 2020-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k200578-infrared-thermometer-model-number-rn-fda-510k.jpg K200578 - Infrared Thermometer Model Number RN-50A,RN-50B K200578 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ningbo Ranor Medical Science & Technology Co., Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k200655/ 2020-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k200655-fibroscan-630-fda-510k.jpg K200655 - FibroScan® 630 K200655 is a FDA 510(k) cleared radiology medical device. Manufacturer: Echosens. Cleared Jul 2020. https://www.510kdatabase.net/k200905/ 2020-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k200905-healthmammo-fda-510k.jpg K200905 - HealthMammo K200905 is a FDA 510(k) cleared radiology medical device. Manufacturer: Zebra Medical Vision, Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k201272/ 2020-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k201272-geneva-fda-510k.jpg K201272 - Geneva K201272 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nucletron B.V.. Cleared Jul 2020. https://www.510kdatabase.net/k201660/ 2020-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k201660-kmti-hip-replacement-system-tesera-fda-510k.jpg K201660 - KMTI Hip Replacement System, Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System K201660 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Kyocera Medical Technologies, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k201662/ 2020-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k201662-reduct-headless-compression-screw-system-fda-510k.jpg K201662 - REDUCT® Headless Compression Screw System K201662 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Skeletal Dynamics, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k201663/ 2020-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k201663-acupulse-w-co2-laser-systems-delivery-fda-510k.jpg K201663 - AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories K201663 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lumenis, Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k201676/ 2020-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k201676-barricaid-instrument-tray-fda-510k.jpg K201676 - Barricaid Instrument Tray K201676 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Intrinsic Therapeutics, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k191146/ 2020-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k191146-humelock-tin-coated-glenosphere-fda-510k.jpg K191146 - Humelock TiN Coated Glenosphere K191146 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Fx Shoulder USA, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k200531/ 2020-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k200531-ihealth-infrared-no-touch-forehead-fda-510k.jpg K200531 - iHealth Infrared No-Touch Forehead Thermometer K200531 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Andon Health Co, Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k200690/ 2020-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k200690-lifesignals-ecg-remote-monitoring-fda-510k.jpg K200690 - LifeSignals ECG Remote Monitoring Patch Platform K200690 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Lifesignals, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k201005/ 2020-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k201005-fullfocus-fda-510k.jpg K201005 - FullFocus K201005 is a FDA 510(k) cleared pathology medical device. Manufacturer: Paige.Ai, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k201018/ 2020-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k201018-encision-aem-entouch-2x-scissor-fda-510k.jpg K201018 - Encision AEM enTouch 2X Scissor K201018 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Encision, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k201064/ 2020-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k201064-v30-system-v20-system-v10-system-v-fr-fda-510k.jpg K201064 - V30 System, V20 System, V10 System, V-FR Handpiece K201064 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Viora , Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k201080/ 2020-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k201080-daily-breeze-b-olifilcon-b-spherical-fda-510k.jpg K201080 - Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Toric Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Multifocal Silicone Hydrogel Soft Contact Lens K201080 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Visco Vision, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k201109/ 2020-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k201109-co2-laser-therapy-system-fda-510k.jpg K201109 - CO2 Laser Therapy System K201109 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shanghai Apolo Medical Technology Co., Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k201149/ 2020-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k201149-colink-plating-system-fda-510k.jpg K201149 - CoLink Plating System K201149 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: In2bones USA, LLC. Cleared Jul 2020. https://www.510kdatabase.net/k201234/ 2020-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k201234-bd-soloshot-mini-syringe-bd-auto-fda-510k.jpg K201234 - BD SoloShot Mini Syringe/ BD Auto Disable Syringe K201234 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson and Company. Cleared Jul 2020. https://www.510kdatabase.net/k201605/ 2020-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k201605-eit-cellular-titanium-cervical-cage-fda-510k.jpg K201605 - EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium ALIF Cage, EIT Cellular Titanium TLIF Cage, EIT Cellular Titanium LLIF Cage, EIT Cellular Titanium T/PLIF Cage K201605 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Eit Emerging Implant Technologies GmbH. Cleared Jul 2020. https://www.510kdatabase.net/k201614/ 2020-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k201614-txtiha-ibf-system-axtiha-stand-alone-fda-510k.jpg K201614 - TxTiHA IBF System, AxTiHA Stand-Alone ALIF System K201614 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Innovasis, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k201618/ 2020-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k201618-nalu-neurostimulation-scs-system-fda-510k.jpg K201618 - Nalu Neurostimulation SCS system K201618 is a FDA 510(k) cleared neurology medical device. Manufacturer: Boston Scientific Neuromodulation. Cleared Jul 2020. https://www.510kdatabase.net/k201621/ 2020-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k201621-magicore-ii-system-fda-510k.jpg K201621 - Magicore II System K201621 is a FDA 510(k) cleared dental medical device. Manufacturer: Innobiosurg Co., Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k193063/ 2020-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k193063-embotrap-iii-revascularization-device-fda-510k.jpg K193063 - EMBOTRAP III Revascularization Device K193063 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neuravi, Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k193097/ 2020-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k193097-vantage-orian-15t-mrt-1550-v60-with-fda-510k.jpg K193097 - Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR K193097 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Jul 2020. https://www.510kdatabase.net/k193515/ 2020-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k193515-mako-total-knee-application-fda-510k.jpg K193515 - Mako Total Knee Application K193515 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Mako Surgical Corp.. Cleared Jul 2020. https://www.510kdatabase.net/k200325/ 2020-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k200325-orbit-subretinal-delivery-system-fda-510k.jpg K200325 - Orbit Subretinal Delivery System K200325 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Orbit Biomedical. Cleared Jul 2020. https://www.510kdatabase.net/k192561/ 2020-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k192561-traus-sus20-fda-510k.jpg K192561 - TRAUS SUS20 K192561 is a FDA 510(k) cleared dental medical device. Manufacturer: Saeshin Precision Co., Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k200218/ 2020-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k200218-digiscan-fdx-fda-510k.jpg K200218 - Digiscan FDX K200218 is a FDA 510(k) cleared radiology medical device. Manufacturer: Allengers Medical Systems Limited. Cleared Jul 2020. https://www.510kdatabase.net/k200960/ 2020-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k200960-medline-powder-free-examination-gloves-fda-510k.jpg K200960 - Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs) K200960 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industires, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k201000/ 2020-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k201000-biodesign-staple-line-reinforcement-fda-510k.jpg K201000 - Biodesign Staple Line Reinforcement K201000 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cook Biotech Incorporated. Cleared Jul 2020. https://www.510kdatabase.net/k201042/ 2020-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k201042-probeat-cr-fda-510k.jpg K201042 - PROBEAT-CR K201042 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hitachi , Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k201276/ 2020-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k201276-exactrac-dynamic-fda-510k.jpg K201276 - ExacTrac Dynamic K201276 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab AG. Cleared Jul 2020. https://www.510kdatabase.net/k201338/ 2020-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k201338-allograft-mis-delivery-system-fda-510k.jpg K201338 - Allograft MIS Delivery System K201338 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lifenet Health. Cleared Jul 2020. https://www.510kdatabase.net/k193627/ 2020-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k193627-automatic-upper-arm-blood-pressure-fda-510k.jpg K193627 - Automatic Upper Arm Blood Pressure Monitor K193627 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Dongguan E-Test Technology Co., Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k193628/ 2020-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k193628-age-automatic-wrist-blood-pressure-fda-510k.jpg K193628 - AGE Automatic Wrist Blood Pressure Monitor K193628 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Dongguan E-Test Technology Co., Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k192969/ 2020-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k192969-ezra-plexo-software-fda-510k.jpg K192969 - Ezra Plexo Software K192969 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ezra Ai, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k192994/ 2020-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k192994-paragon-28-apex-3d-total-ankle-fda-510k.jpg K192994 - Paragon 28 APEX 3D Total Ankle Replacement System K192994 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paragon 28, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k193294/ 2020-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k193294-ai-rad-companion-engine-fda-510k.jpg K193294 - AI-Rad Companion Engine K193294 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k193559/ 2020-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k193559-nextar-tka-platform-fda-510k.jpg K193559 - NextAR TKA Platform K193559 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta Inernational SA. Cleared Jul 2020. https://www.510kdatabase.net/k193624/ 2020-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k193624-automatic-upper-arm-blood-pressure-fda-510k.jpg K193624 - Automatic Upper Arm Blood Pressure Monitor K193624 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Dongguan E-Test Technology Co., Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k200047/ 2020-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k200047-excelsiusgps-cranial-10-module-fda-510k.jpg K200047 - ExcelsiusGPS Cranial 1.0 Module K200047 is a FDA 510(k) cleared neurology medical device. Manufacturer: Globus Medical, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k200203/ 2020-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k200203-infrascanner-fda-510k.jpg K200203 - Infrascanner K200203 is a FDA 510(k) cleared neurology medical device. Manufacturer: Infrascan, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k200409/ 2020-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k200409-pelvital-system-fda-510k.jpg K200409 - Pelvital System K200409 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Pelvital USA, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k200427/ 2020-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k200427-sonicision-cordless-ultrasonic-dissector-fda-510k.jpg K200427 - Sonicision Cordless Ultrasonic Dissector K200427 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien, LLC. Cleared Jul 2020. https://www.510kdatabase.net/k200449/ 2020-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k200449-x-cube-90-fda-510k.jpg K200449 - X-Cube 90 K200449 is a FDA 510(k) cleared radiology medical device. Manufacturer: Alpinion Medical Systems Co., Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k200450/ 2020-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k200450-x-cube-70-fda-510k.jpg K200450 - X-Cube 70 K200450 is a FDA 510(k) cleared radiology medical device. Manufacturer: Alpinion Medical Systems Co., Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k200480/ 2020-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k200480-dreamstation-2-system-dreamstation-2-fda-510k.jpg K200480 - DreamStation 2 System, DreamStation 2 Advanced System K200480 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k200568/ 2020-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k200568-bj-mhp800-deep-vein-thrombosis-dvt-fda-510k.jpg K200568 - B&J MHP800 Deep Vein Thrombosis (DVT) Prevention System K200568 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: B&J Manufacturing , Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k200856/ 2020-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k200856-smartlinx-vitals-plus-patient-fda-510k.jpg K200856 - SmartLinx Vitals Plus Patient Monitoring System K200856 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Capsule Technologie Sas. Cleared Jul 2020. https://www.510kdatabase.net/k201243/ 2020-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k201243-disposable-specimen-retrieval-bag-fda-510k.jpg K201243 - Disposable Specimen Retrieval Bag K201243 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Beijing Biosis Healing Biolog Ical Technology Co., Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k201279/ 2020-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k201279-assisto-universal-applicator-clamping-fda-510k.jpg K201279 - ASSISTO Universal Applicator Clamping Device K201279 is a FDA 510(k) cleared radiology medical device. Manufacturer: Geomed Medizin-Technik GmbH & Co. KG. Cleared Jul 2020. https://www.510kdatabase.net/k201299/ 2020-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k201299-hd-steth-fda-510k.jpg K201299 - HD Steth K201299 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hd Medical, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k201343/ 2020-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k201343-triathlon-total-kneesystem-fda-510k.jpg K201343 - Triathlon Total KneeSystem K201343 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp., Dba Stryker Orthopaedics. Cleared Jul 2020. https://www.510kdatabase.net/k201389/ 2020-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k201389-resoundant-acoustic-driver-system-fda-510k.jpg K201389 - Resoundant Acoustic Driver System K201389 is a FDA 510(k) cleared radiology medical device. Manufacturer: Resoundant, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k201607/ 2020-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k201607-eclipse-treatment-planning-system-v161-fda-510k.jpg K201607 - Eclipse Treatment Planning System v16.1 K201607 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k201725/ 2020-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k201725-digitaldiagnost-c50-fda-510k.jpg K201725 - DigitalDiagnost C50 K201725 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Healthcare (Suzhou) Co., Lit.. Cleared Jul 2020. https://www.510kdatabase.net/k192928/ 2020-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k192928-optiflux-enexa-f500-dialyzer-fda-510k.jpg K192928 - Optiflux Enexa F500 Dialyzer K192928 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fresenius Medical Care Reanal Therapies Group, LLC. Cleared Jul 2020. https://www.510kdatabase.net/k193113/ 2020-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k193113-gc-temp-print-fda-510k.jpg K193113 - GC Temp Print K193113 is a FDA 510(k) cleared dental medical device. Manufacturer: GC America, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k193272/ 2020-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k193272-gtk-trocars-fda-510k.jpg K193272 - GTK Trocars K193272 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Guangzhou T.K Medical Instrument Co., Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k200061/ 2020-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k200061-heatfx-microwave-ablation-system-fda-510k.jpg K200061 - HEATfx Microwave Ablation System, HEATfx Microwave Ablation System Cart, HEATfx 2.1 Needle, HEATfx 2.1 S Needle, Multi-Point Thermal Sensor (MTS) K200061 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Galil Medical, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k200637/ 2020-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k200637-sr-8100-portable-x-ray-unit-fda-510k.jpg K200637 - SR-8100 Portable X-ray Unit K200637 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui). Cleared Jul 2020. https://www.510kdatabase.net/k200823/ 2020-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k200823-zimmer-inc-hip-joint-prostheses-mr-fda-510k.jpg K200823 - Zimmer, Inc. Hip Joint Prostheses MR Labeling I K200823 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k200941/ 2020-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k200941-rapid-lvo-fda-510k.jpg K200941 - Rapid LVO K200941 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ischemaview, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k201035/ 2020-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k201035-ethicon-linx-esophagus-sizing-tool-fda-510k.jpg K201035 - ETHICON Linx Esophagus Sizing Tool K201035 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Torax Medical, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k201296/ 2020-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k201296-i-rapha-solution-fda-510k.jpg K201296 - i-Rapha Solution K201296 is a FDA 510(k) cleared radiology medical device. Manufacturer: Irm, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k201586/ 2020-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k201586-xact-robotic-system-fda-510k.jpg K201586 - XACT Robotic System K201586 is a FDA 510(k) cleared radiology medical device. Manufacturer: Xact Robotics, Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k201640/ 2020-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k201640-duradiagnost-fda-510k.jpg K201640 - DuraDiagnost K201640 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Healthcare (Suzhou) Co., Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k192231/ 2020-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k192231-dental-glass-ceramics-blocks-fda-510k.jpg K192231 - Dental Glass Ceramics Blocks K192231 is a FDA 510(k) cleared dental medical device. Manufacturer: Aidite (Qinhuangdao) Technology Co., Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k193345/ 2020-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k193345-arthrex-dynanite-compression-plate-fda-510k.jpg K193345 - Arthrex DynaNite Compression Plate K193345 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k200154/ 2020-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k200154-bj-dvt-compression-devices-fda-510k.jpg K200154 - B&J DVT Compression Devices MHH800/MHH800SQ K200154 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: B&J Manufacturing , Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k200599/ 2020-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k200599-digital-thermometer-fda-510k.jpg K200599 - Digital Thermometer K200599 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Joytech Healthcare Co. , Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k200656/ 2020-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k200656-delta-multihole-tt-pro-acetabular-system-fda-510k.jpg K200656 - Delta Multihole TT Pro Acetabular System K200656 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Lima Corporate S.P.A.. Cleared Jul 2020. https://www.510kdatabase.net/k200676/ 2020-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k200676-abro-1-resiton-gingiva-prime-and-fda-510k.jpg K200676 - ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA K200676 is a FDA 510(k) cleared dental medical device. Manufacturer: Zirkonzahn Srl. Cleared Jul 2020. https://www.510kdatabase.net/k200955/ 2020-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k200955-vascutek-gelseal-patch-vascutek-fda-510k.jpg K200955 - Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch K200955 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vascutek, Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k201216/ 2020-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k201216-capere-thrombectomy-system-fda-510k.jpg K201216 - CAPERE Thrombectomy System K201216 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vascular Medcure, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k201307/ 2020-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k201307-viscalor-fda-510k.jpg K201307 - VisCalor K201307 is a FDA 510(k) cleared dental medical device. Manufacturer: Voco GmbH. Cleared Jul 2020. https://www.510kdatabase.net/k201542/ 2020-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k201542-arthrex-eclipse-shoulder-prosthesis-fda-510k.jpg K201542 - Arthrex Eclipse Shoulder Prosthesis System K201542 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k201556/ 2020-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k201556-intraosseous-fixation-system-fda-510k.jpg K201556 - Intraosseous Fixation System K201556 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Extremity Medical, LLC. Cleared Jul 2020. https://www.510kdatabase.net/k201571/ 2020-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k201571-activac-negative-pressure-wound-fda-510k.jpg K201571 - ACTIV.A.C. Negative Pressure Wound Therapy System K201571 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Kci USA, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k201575/ 2020-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k201575-cmdr-2c-multiple-models-fda-510k.jpg K201575 - CMDR 2C (Multiple Models) K201575 is a FDA 510(k) cleared radiology medical device. Manufacturer: Minxray, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k201593/ 2020-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k201593-looking-glass-4k-integrated-fda-510k.jpg K201593 - Looking Glass 4K Integrated Visualization System K201593 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Conmed Corporation. Cleared Jul 2020. https://www.510kdatabase.net/k200392/ 2020-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k200392-rexsin-fda-510k.jpg K200392 - REXSIN K200392 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sm Eng Co., Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k191152/ 2020-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k191152-mis-ti-base-abutment-fda-510k.jpg K191152 - MIS Ti-base Abutment K191152 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona. Cleared Jul 2020. https://www.510kdatabase.net/k193073/ 2020-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k193073-deep-recon-fda-510k.jpg K193073 - Deep Recon K193073 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k200330/ 2020-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k200330-rc-prime-root-canal-preparation-cream-fda-510k.jpg K200330 - RC-Prime Root Canal Preparation Cream K200330 is a FDA 510(k) cleared dental medical device. Manufacturer: Pac-Dent, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k200652/ 2020-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k200652-lollipop-biteblock-fda-510k.jpg K200652 - Lollipop BiteBlock K200652 is a FDA 510(k) cleared radiology medical device. Manufacturer: Radtec Medical Devices, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k200850/ 2020-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k200850-fujifilm-ultrasonic-processor-fda-510k.jpg K200850 - Fujifilm Ultrasonic Processor K200850 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fujifilm Corporation. Cleared Jul 2020. https://www.510kdatabase.net/k201235/ 2020-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k201235-arthrex-maxforce-mtp-compression-fda-510k.jpg K201235 - Arthrex MaxForce MTP Compression Plates and Screws K201235 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k201540/ 2020-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k201540-umr570-fda-510k.jpg K201540 - uMR570 K201540 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k200537/ 2020-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k200537-oxxiom-fda-510k.jpg K200537 - Oxxiom K200537 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: True Wearables, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k200795/ 2020-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k200795-linq-ii-insertable-cardiac-monitor-fda-510k.jpg K200795 - LINQ II Insertable Cardiac Monitor, LINQ Mobile Manager, Device Command Library, Instrument Command Library, LINQ Tool Kit K200795 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k183471/ 2020-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k183471-ic-whcd100-inspire-fda-510k.jpg K183471 - IC-WHCD100 (Inspire) K183471 is a FDA 510(k) cleared dental medical device. Manufacturer: Good Doctors Co., Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k192385/ 2020-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k192385-ivwatch-model-400-device-accessories-fda-510k.jpg K192385 - ivWatch Model 400, Device Accessories: Extension Module, SmartTouch Sensor, Patient Cable K192385 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ivwatch, LLC. Cleared Jul 2020. https://www.510kdatabase.net/k192411/ 2020-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k192411-psoria-shield-aurora-fda-510k.jpg K192411 - Psoria-Shield AURORA K192411 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Psoria-Shield. Cleared Jul 2020. https://www.510kdatabase.net/k192872/ 2020-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k192872-ulrichinject-ct-motion-fda-510k.jpg K192872 - ulrichINJECT CT Motion K192872 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ulrich GmbH & Co. KG. Cleared Jul 2020. https://www.510kdatabase.net/k192880/ 2020-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k192880-inferread-lung-ctai-fda-510k.jpg K192880 - InferRead Lung CT.AI K192880 is a FDA 510(k) cleared radiology medical device. Manufacturer: Beijing Infervision Technology Co., Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k193172/ 2020-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k193172-luna-xd-ti-interbody-fusion-system-fda-510k.jpg K193172 - Luna XD Ti Interbody Fusion System K193172 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Benvenue Medical, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k193252/ 2020-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k193252-contour-protegeai-fda-510k.jpg K193252 - Contour ProtegeAI K193252 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mim Software, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k193259/ 2020-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k193259-aneroid-sphygmomanometer-with-fda-510k.jpg K193259 - Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer K193259 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Little Doctor Electronic (Nantong)Co.,Ltd. Cleared Jul 2020. https://www.510kdatabase.net/k193484/ 2020-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k193484-gc-fuji-triage-ep-fda-510k.jpg K193484 - GC Fuji Triage EP K193484 is a FDA 510(k) cleared dental medical device. Manufacturer: GC America, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k200285/ 2020-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k200285-venaone-fda-510k.jpg K200285 - VenaOne K200285 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vena Group, LLC. Cleared Jul 2020. https://www.510kdatabase.net/k200674/ 2020-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k200674-atriamp-atriamp-pacing-cable-medtronic-fda-510k.jpg K200674 - AtriAmp, AtriAmp - Pacing Cable Medtronic Connector, AtriAmp - Pacing Cable Oscor Connector K200674 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Atrility Medical, LLC. Cleared Jul 2020. https://www.510kdatabase.net/k200766/ 2020-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k200766-3m-attest-steam-chemical-integrator-fda-510k.jpg K200766 - 3M Attest Steam Chemical Integrator Test Pack K200766 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Jul 2020. https://www.510kdatabase.net/k200894/ 2020-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k200894-agape-cooling-personal-lubricant-fda-510k.jpg K200894 - Agape Cooling Personal Lubricant K200894 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: CC Wellness, LLC. Cleared Jul 2020. https://www.510kdatabase.net/k200947/ 2020-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k200947-inmode-system-with-the-morhpeus8-fda-510k.jpg K200947 - InMode System with the Morhpeus8 Applicators K200947 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Inmode , Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k201048/ 2020-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k201048-sherpapak-pediatric-liver-transport-fda-510k.jpg K201048 - SherpaPak Pediatric Liver Transport System K201048 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Paragonix Technologies. Cleared Jul 2020. https://www.510kdatabase.net/k201487/ 2020-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k201487-traxcess-7-mini-guidewire-fda-510k.jpg K201487 - Traxcess 7 Mini Guidewire K201487 is a FDA 510(k) cleared neurology medical device. Manufacturer: MicroVention, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k201599/ 2020-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k201599-2mp-colormonochrome-lcd-monitors-c22s-fda-510k.jpg K201599 - 2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+ K201599 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Beacon Display Technology Co., Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k201633/ 2020-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k201633-terason-usmart-3200t-plus-ultrasound-fda-510k.jpg K201633 - Terason uSmart 3200T Plus Ultrasound System K201633 is a FDA 510(k) cleared radiology medical device. Manufacturer: Teratech Corporation. Cleared Jul 2020. https://www.510kdatabase.net/k200138/ 2020-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k200138-versana-premier-fda-510k.jpg K200138 - Versana Premier K200138 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems Ultrasound And. Cleared Jul 2020. https://www.510kdatabase.net/k200248/ 2020-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k200248-allwin-embryo-transfer-catheters-etc-fda-510k.jpg K200248 - Allwin Embryo Transfer Catheters (ETC), Allwin ETC Stylets and Soft Obturators K200248 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Allwin Medical Devices, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k200561/ 2020-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k200561-stimplus-patch-stimplus-patch-stimplus-fda-510k.jpg K200561 - StimPlus Patch, StimPlus Patch, StimPlus Patch K200561 is a FDA 510(k) cleared neurology medical device. Manufacturer: Jkh Health Co., Ltd.. Cleared Jul 2020. https://www.510kdatabase.net/k200880/ 2020-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k200880-t2-tibial-nailing-system-t2-femoral-fda-510k.jpg K200880 - T2 Tibial Nailing System, T2 Femoral Nail System, T2 Supracondylar Nail System, T2 Recon Nail System, T2 Greater Trochanter Nail (GTN),T2 Ankle Arthrodesis Nail,T2 Arthrodesis Nail System K200880 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker GmbH. Cleared Jul 2020. https://www.510kdatabase.net/k201449/ 2020-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k201449-simuplus-flexible-annuloplasty-ring-fda-510k.jpg K201449 - SimuPlus Flexible Annuloplasty Ring, SimuPlus Flexible Annuloplasty Band, SimuForm Semi-Rigid Annuloplasty Ring K201449 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Jul 2020. https://www.510kdatabase.net/k201477/ 2020-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k201477-syngovia-viewgo-fda-510k.jpg K201477 - syngo.via View&GO K201477 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Healthcare GmbH. Cleared Jul 2020. https://www.510kdatabase.net/k191276/ 2020-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k191276-dental-electrical-motor-iroot-pro-fda-510k.jpg K191276 - Dental Electrical Motor iRoot Pro K191276 is a FDA 510(k) cleared dental medical device. Manufacturer: Changzhou Bomedent Medical Technology Co.,Ltd. Cleared Jun 2020. https://www.510kdatabase.net/k192778/ 2020-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k192778-kinos-axiom-total-ankle-system-fda-510k.jpg K192778 - Kinos Axiom Total Ankle System K192778 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Kinos Medical. Cleared Jun 2020. https://www.510kdatabase.net/k193632/ 2020-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k193632-lassostar-circular-mapping-catheter-fda-510k.jpg K193632 - LassoStar Circular Mapping Catheter K193632 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biosense Webster, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k200265/ 2020-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k200265-surgical-drills-fda-510k.jpg K200265 - Surgical Drills K200265 is a FDA 510(k) cleared dental medical device. Manufacturer: Implant Direct Sybron Manufacturing, LLC. Cleared Jun 2020. https://www.510kdatabase.net/k200272/ 2020-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k200272-terragene-chemdye-fda-510k.jpg K200272 - Terragene Chemdye K200272 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terragene S.A.. Cleared Jun 2020. https://www.510kdatabase.net/k200874/ 2020-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k200874-truview-light-cable-truview-lateral-fda-510k.jpg K200874 - TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal End K200874 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Innovasis, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k201455/ 2020-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k201455-litho-150-cyber-ho-150-fda-510k.jpg K201455 - Litho 150, Cyber Ho 150 K201455 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Quanta System Spa. Cleared Jun 2020. https://www.510kdatabase.net/k201464/ 2020-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k201464-altapore-mis-fda-510k.jpg K201464 - Altapore MIS K201464 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Baxter Healthcare Corporation. Cleared Jun 2020. https://www.510kdatabase.net/k192900/ 2020-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k192900-h500-multi-sensing-oximetry-system-fda-510k.jpg K192900 - H500 Multi-Sensing Oximetry System K192900 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Nonin Medical, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k193119/ 2020-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k193119-twin-pass-dual-access-catheter-fda-510k.jpg K193119 - Twin-Pass Dual Access Catheter K193119 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vascular Solutions, LLC. Cleared Jun 2020. https://www.510kdatabase.net/k200068/ 2020-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k200068-arthrex-dynanite-k-wire-fda-510k.jpg K200068 - Arthrex DynaNite K-Wire K200068 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k200354/ 2020-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k200354-electronic-stimulator-fda-510k.jpg K200354 - Electronic stimulator K200354 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Dongjilian Electronics Co., Ltd.. Cleared Jun 2020. https://www.510kdatabase.net/k200420/ 2020-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k200420-echelon-contour-curved-cutter-with-fda-510k.jpg K200420 - Echelon Contour Curved Cutter with blue reload, Echelon Contour Curved Cutter with green reload, Echelon Contour Curved Cutter reload, Blue, Echelon Contour Curved Cutter reload, Green K200420 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon Endo-Surgery, LLC. Cleared Jun 2020. https://www.510kdatabase.net/k200698/ 2020-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k200698-somnera-system-fda-510k.jpg K200698 - Somnera System K200698 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Fresca Medical, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k201156/ 2020-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k201156-artis-pheno-ve2-fda-510k.jpg K201156 - ARTIS pheno (VE2) K201156 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solution USA, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k201423/ 2020-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k201423-microscan-dried-gram-negative-miccombo-fda-510k.jpg K201423 - MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL) K201423 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k201503/ 2020-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k201503-edge-air1417-digital-flat-panel-x-ray-fda-510k.jpg K201503 - Edge Air(1417) Digital Flat Panel X-ray Detector K201503 is a FDA 510(k) cleared radiology medical device. Manufacturer: Osko, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k201507/ 2020-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k201507-cadence-total-ankle-system-fda-510k.jpg K201507 - Cadence Total Ankle System K201507 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Integra LifeSciences Corporation. Cleared Jun 2020. https://www.510kdatabase.net/k200888/ 2020-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k200888-omnibotics-knee-system-fda-510k.jpg K200888 - OMNIBotics Knee System K200888 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corin, Ltd.. Cleared Jun 2020. https://www.510kdatabase.net/k182081/ 2020-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k182081-jdentalcare-implant-system-jdicon-fda-510k.jpg K182081 - JDentalCare Implant System JDIcon K182081 is a FDA 510(k) cleared dental medical device. Manufacturer: Jdentalcare Srl. Cleared Jun 2020. https://www.510kdatabase.net/k191443/ 2020-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k191443-msdi-dental-implants-system-fda-510k.jpg K191443 - MSDI Dental Implants System K191443 is a FDA 510(k) cleared dental medical device. Manufacturer: Medical Systems and Devices International , Ltd.. Cleared Jun 2020. https://www.510kdatabase.net/k193042/ 2020-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k193042-optimized-positioning-system-ops-review-fda-510k.jpg K193042 - Optimized Positioning System (OPS) ReView K193042 is a FDA 510(k) cleared radiology medical device. Manufacturer: Corin USA. Cleared Jun 2020. https://www.510kdatabase.net/k193473/ 2020-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k193473-lux-dx-insertable-cardiac-monitor-fda-510k.jpg K193473 - LUX-Dx Insertable Cardiac Monitor, myLUX Software Mobile Application, LUX-Dx Clinic Assistant Software, Application Server Device Services (DS) - US K193473 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Jun 2020. https://www.510kdatabase.net/k193525/ 2020-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k193525-yumizen-c1200-immunoglobulin-a-yumizen-fda-510k.jpg K193525 - Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M K193525 is a FDA 510(k) cleared immunology medical device. Manufacturer: HORIBA ABX SAS. Cleared Jun 2020. https://www.510kdatabase.net/k193600/ 2020-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k193600-endogi-biliary-stent-system-fda-510k.jpg K193600 - EndoGI Biliary Stent System K193600 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Endogi Medical, Ltd.. Cleared Jun 2020. https://www.510kdatabase.net/k200095/ 2020-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k200095-streamline-navigated-instruments-fda-510k.jpg K200095 - Streamline Navigated Instruments K200095 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.). Cleared Jun 2020. https://www.510kdatabase.net/k200226/ 2020-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k200226-retrofix-fda-510k.jpg K200226 - RetroFix K200226 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Retrofix Screws, LLC. Cleared Jun 2020. https://www.510kdatabase.net/k200250/ 2020-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k200250-megadyne-smoke-evacuator-megadyne-fda-510k.jpg K200250 - Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor K200250 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Megadyne Medical Products, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k200720/ 2020-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k200720-d-stat-radial-topical-hemostat-fda-510k.jpg K200720 - D-Stat Radial Topical Hemostat K200720 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Vascular Solutions, LLC. Cleared Jun 2020. https://www.510kdatabase.net/k200723/ 2020-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k200723-stealthstation-flexent-9736242-fda-510k.jpg K200723 - StealthStation FlexENT (9736242), StealthStation S8 ENT Software (9735762) K200723 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Medtronic Navigation, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k200736/ 2020-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k200736-stardust-med-fda-510k.jpg K200736 - Stardust Med K200736 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: I.T.S. Group S.R.L.. Cleared Jun 2020. https://www.510kdatabase.net/k200760/ 2020-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k200760-rapid-aspects-fda-510k.jpg K200760 - Rapid ASPECTS K200760 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ischemaview, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k200825/ 2020-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k200825-noveos-specific-ige-sige-capture-fda-510k.jpg K200825 - NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus K200825 is a FDA 510(k) cleared immunology medical device. Manufacturer: Hycor Biomedical. Cleared Jun 2020. https://www.510kdatabase.net/k200840/ 2020-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k200840-duohex-ch-cannulated-hammertoe-system-fda-510k.jpg K200840 - DuoHex CH Cannulated Hammertoe System K200840 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nextremity Solutions, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k201119/ 2020-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k201119-chartcheck-fda-510k.jpg K201119 - ChartCheck K201119 is a FDA 510(k) cleared radiology medical device. Manufacturer: Radformation, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k201146/ 2020-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k201146-ion-endoluminal-system-fda-510k.jpg K201146 - Ion Endoluminal System K201146 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k201148/ 2020-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k201148-ensite-precision-cardiac-mapping-fda-510k.jpg K201148 - EnSite Precision Cardiac Mapping System v2.6, EnSite Precision Software Installation v2.6, EnSite LiveView Dynamic Display Software License K201148 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared Jun 2020. https://www.510kdatabase.net/k201164/ 2020-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k201164-venus-viva-md-device-fda-510k.jpg K201164 - Venus Viva MD Device K201164 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Venus Concept USA, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k201181/ 2020-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k201181-ensite-velocity-cardiac-mapping-system-fda-510k.jpg K201181 - EnSite Velocity Cardiac Mapping System, EnSite Precision Cardiac Mapping System K201181 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared Jun 2020. https://www.510kdatabase.net/k201373/ 2020-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k201373-drx-compass-fda-510k.jpg K201373 - DRX-Compass K201373 is a FDA 510(k) cleared radiology medical device. Manufacturer: Carestream Health, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k192028/ 2020-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k192028-yumizen-c1200-crp-fda-510k.jpg K192028 - Yumizen C1200 CRP K192028 is a FDA 510(k) cleared immunology medical device. Manufacturer: HORIBA ABX SAS. Cleared Jun 2020. https://www.510kdatabase.net/k192221/ 2020-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k192221-legacy2-legacy3-legacy4-simplylegacy2-fda-510k.jpg K192221 - Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants K192221 is a FDA 510(k) cleared dental medical device. Manufacturer: Implant Direct Sybron Manufacturing, LLC. Cleared Jun 2020. https://www.510kdatabase.net/k193348/ 2020-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k193348-blood-pressure-monitor-fda-510k.jpg K193348 - Blood Pressure Monitor K193348 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Viatom Technology Co., Ltd.. Cleared Jun 2020. https://www.510kdatabase.net/k200175/ 2020-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k200175-dia-root-bio-sealer-fda-510k.jpg K200175 - DIA-ROOT BIO Sealer K200175 is a FDA 510(k) cleared dental medical device. Manufacturer: DiaDent Group International. Cleared Jun 2020. https://www.510kdatabase.net/k200295/ 2020-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k200295-illuminoss-bone-stabilization-system-fda-510k.jpg K200295 - IlluminOss Bone Stabilization System K200295 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Illuminoss Medical, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k200437/ 2020-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k200437-blood-pressure-monitor-fda-510k.jpg K200437 - Blood Pressure Monitor K200437 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Jamr Technology Co., Ltd.. Cleared Jun 2020. https://www.510kdatabase.net/k200582/ 2020-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k200582-bendit27-steerable-microcatheter-fda-510k.jpg K200582 - Bendit2.7 Steerable Microcatheter K200582 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bend IT Technologies, Ltd.. Cleared Jun 2020. https://www.510kdatabase.net/k200614/ 2020-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k200614-fitebac-antimicrobial-cavity-cleanser-fda-510k.jpg K200614 - FiteBac Antimicrobial Cavity Cleanser K200614 is a FDA 510(k) cleared dental medical device. Manufacturer: Largent Health, LLC. Cleared Jun 2020. https://www.510kdatabase.net/k200815/ 2020-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k200815-vitriguard-fda-510k.jpg K200815 - VitriGuard K200815 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Origio A/S. Cleared Jun 2020. https://www.510kdatabase.net/k200834/ 2020-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k200834-lever-action-plate-system-fda-510k.jpg K200834 - Lever Action Plate System K200834 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Mcginley Orthpaedic Innovations, LLC. Cleared Jun 2020. https://www.510kdatabase.net/k201414/ 2020-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k201414-rotium-bioresorbable-wick-fda-510k.jpg K201414 - Rotium Bioresorbable Wick K201414 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nanofiber Solutions, LLC. Cleared Jun 2020. https://www.510kdatabase.net/k192710/ 2020-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k192710-the-simple-locking-intramedullary-slim-fda-510k.jpg K192710 - The Simple Locking Intramedullary (Slim) System K192710 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Pega Medical, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k193477/ 2020-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k193477-nd-yag-laser-therapy-systems-fda-510k.jpg K193477 - Nd: YAG Laser Therapy Systems K193477 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Beijing Kes Biology Technology Co., Ltd.. Cleared Jun 2020. https://www.510kdatabase.net/k200445/ 2020-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k200445-the-c100-contactless-breathing-monitor-fda-510k.jpg K200445 - The C100 Contactless Breathing Monitor K200445 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Circadia Technologies, Ltd.. Cleared Jun 2020. https://www.510kdatabase.net/k200495/ 2020-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k200495-andorate-disposable-airwater-valve-fda-510k.jpg K200495 - Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve K200495 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ga Health Company Limited. Cleared Jun 2020. https://www.510kdatabase.net/k200663/ 2020-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k200663-controlrad-trace-model-9-fda-510k.jpg K200663 - ControlRad Trace Model 9 K200663 is a FDA 510(k) cleared radiology medical device. Manufacturer: Controlrad, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k200855/ 2020-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k200855-cina-fda-510k.jpg K200855 - CINA K200855 is a FDA 510(k) cleared radiology medical device. Manufacturer: Avicenna.Ai. Cleared Jun 2020. https://www.510kdatabase.net/k200975/ 2020-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k200975-sonicaid-team3-antepartum-sonicaid-fda-510k.jpg K200975 - Sonicaid Team3 Antepartum, Sonicaid Team3 Intrapartum K200975 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Huntleigh Healthcare Limited. Cleared Jun 2020. https://www.510kdatabase.net/k201462/ 2020-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k201462-acuson-sequoia-diagnostic-ultrasound-fda-510k.jpg K201462 - ACUSON Sequoia Diagnostic Ultrasound System K201462 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k200232/ 2020-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k200232-lvivo-software-application-fda-510k.jpg K200232 - LVivo Software Application K200232 is a FDA 510(k) cleared radiology medical device. Manufacturer: Dia Imaging Analysis, Ltd.. Cleared Jun 2020. https://www.510kdatabase.net/k200617/ 2020-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k200617-logic-hd-camera-controller-logic-hd-fda-510k.jpg K200617 - Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter for Controller 5525 K200617 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Richard Wolf Medical Instruments Corporation. Cleared Jun 2020. https://www.510kdatabase.net/k200772/ 2020-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k200772-ulab-systems-udesign-software-fda-510k.jpg K200772 - ULab Systems uDesign Software K200772 is a FDA 510(k) cleared dental medical device. Manufacturer: Ulab Systems, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k200774/ 2020-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k200774-cusa-clarity-ultrasonic-surgical-fda-510k.jpg K200774 - CUSA Clarity Ultrasonic Surgical Aspirator System K200774 is a FDA 510(k) cleared neurology medical device. Manufacturer: Integra LifeSciences Corporation. Cleared Jun 2020. https://www.510kdatabase.net/k201096/ 2020-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k201096-co2mbiled-fda-510k.jpg K201096 - CO2mbiLED K201096 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k201668/ 2020-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k201668-varseosmile-crown-plus-fda-510k.jpg K201668 - VarseoSmile Crown plus K201668 is a FDA 510(k) cleared dental medical device. Manufacturer: Bego Bremer Goldschl?gerei Wilh. Herbst GmbH & Co. KG. Cleared Jun 2020. https://www.510kdatabase.net/k192337/ 2020-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k192337-zeroveno-fda-510k.jpg K192337 - Zeroveno K192337 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Dimedi Co., Ltd.. Cleared Jun 2020. https://www.510kdatabase.net/k192404/ 2020-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k192404-patient-monitoring-cable-spo2-fda-510k.jpg K192404 - Patient Monitoring Cable (SpO2 Extension Cable) K192404 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Coreray Technology, Ltd.. Cleared Jun 2020. https://www.510kdatabase.net/k192466/ 2020-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k192466-air-compression-therapy-system-fda-510k.jpg K192466 - Air Compression Therapy System K192466 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.. Cleared Jun 2020. https://www.510kdatabase.net/k192549/ 2020-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k192549-byteflies-kit-fda-510k.jpg K192549 - Byteflies Kit K192549 is a FDA 510(k) cleared neurology medical device. Manufacturer: Byteflies NV. Cleared Jun 2020. https://www.510kdatabase.net/k200195/ 2020-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k200195-nes-reprocessed-visions-pv-014p-rx-fda-510k.jpg K200195 - NES Reprocessed Visions PV .014P RX Digital IVUS Catheter K200195 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Northeast Scientific, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k200627/ 2020-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k200627-glidepath-10f-long-term-dialysis-fda-510k.jpg K200627 - GlidePath 10F Long-Term Dialysis Catheter K200627 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k201107/ 2020-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k201107-opera-lebody-gold-opera-lebody-zafiro-fda-510k.jpg K201107 - Opera Lebody (Gold), Opera Lebody (Zafiro) K201107 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Gtg Wellness Co., Ltd.. Cleared Jun 2020. https://www.510kdatabase.net/k201140/ 2020-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k201140-axeos-fda-510k.jpg K201140 - Axeos K201140 is a FDA 510(k) cleared radiology medical device. Manufacturer: Dentsply Sirona. Cleared Jun 2020. https://www.510kdatabase.net/k201151/ 2020-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k201151-o-mec-690-series-laparoscopes-fda-510k.jpg K201151 - O-Mec 690 Series Laparoscopes K201151 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Omec Medical, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k191923/ 2020-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k191923-everlift-submucosal-lifting-agent-fda-510k.jpg K191923 - EverLift Submucosal Lifting Agent K191923 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Gi Supply. Cleared Jun 2020. https://www.510kdatabase.net/k201430/ 2020-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k201430-inframe-cannulated-fixation-system-fda-510k.jpg K201430 - InFrame™ Cannulated Fixation System K201430 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exsomed Corp.. Cleared Jun 2020. https://www.510kdatabase.net/k190637/ 2020-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k190637-fit-brilliant-dental-implant-system-fda-510k.jpg K190637 - Fit & Brilliant Dental Implant System K190637 is a FDA 510(k) cleared dental medical device. Manufacturer: F&B Technology Co., Ltd.. Cleared Jun 2020. https://www.510kdatabase.net/k191913/ 2020-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k191913-truabutment-ds-fda-510k.jpg K191913 - TruAbutment DS K191913 is a FDA 510(k) cleared dental medical device. Manufacturer: Truabutment, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k192024/ 2020-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k192024-cemented-tsi-hip-stem-fda-510k.jpg K192024 - Cemented TSI Hip Stem K192024 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Signature Orthopaedics Pty, Ltd.. Cleared Jun 2020. https://www.510kdatabase.net/k192910/ 2020-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k192910-statclave-g4-chamber-autoclave-fda-510k.jpg K192910 - STATClave G4 Chamber Autoclave K192910 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Scican , Ltd.. Cleared Jun 2020. https://www.510kdatabase.net/k192954/ 2020-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k192954-power-free-nitrile-examination-gloves-fda-510k.jpg K192954 - Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl K192954 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Comfort Rubber Gloves Industries Sdn. Bhd.. Cleared Jun 2020. https://www.510kdatabase.net/k192963/ 2020-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k192963-kogent-torus-ultrasonic-aspirator-fda-510k.jpg K192963 - Kogent Torus Ultrasonic Aspirator K192963 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Katalyst Surgical, LLC. Cleared Jun 2020. https://www.510kdatabase.net/k193106/ 2020-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k193106-spinefrontier-lumbar-interbody-fusion-fda-510k.jpg K193106 - SpineFrontier Lumbar Interbody Fusion Device System K193106 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinefrontier, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k193298/ 2020-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k193298-briefcase-fda-510k.jpg K193298 - BriefCase K193298 is a FDA 510(k) cleared radiology medical device. Manufacturer: Aidoc Medical , Ltd.. Cleared Jun 2020. https://www.510kdatabase.net/k200438/ 2020-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k200438-mps-3-myocardial-protection-system-fda-510k.jpg K200438 - MPS 3 Myocardial Protection System K200438 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quest Medical, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k200471/ 2020-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k200471-infrared-thermometer-model-number-rn-fda-510k.jpg K200471 - Infrared Thermometer Model Number RN-60A,RN-60B K200471 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ningbo Ranor Medical Science & Technology Co., Ltd.. Cleared Jun 2020. https://www.510kdatabase.net/k200574/ 2020-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k200574-eksonr-fda-510k.jpg K200574 - EksoNR K200574 is a FDA 510(k) cleared neurology medical device. Manufacturer: Ekso Bionics, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k200671/ 2020-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k200671-microflex-nitrile-patient-examination-fda-510k.jpg K200671 - Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green Pink Colored Tested for K200671 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ansell Healthcare Products, LLC. Cleared Jun 2020. https://www.510kdatabase.net/k201339/ 2020-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k201339-the-noxboxi-nitric-oxide-delivery-system-fda-510k.jpg K201339 - The NOxBOXi Nitric Oxide Delivery System K201339 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Praxair, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k201340/ 2020-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k201340-aquila-320-d-aquila-320-s-fda-510k.jpg K201340 - AQUILA 320 D / AQUILA 320 S K201340 is a FDA 510(k) cleared radiology medical device. Manufacturer: Vmi Tecnologias Ltda. Cleared Jun 2020. https://www.510kdatabase.net/k201370/ 2020-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k201370-multiflex-tinnitus-technology-fda-510k.jpg K201370 - Multiflex Tinnitus Technology K201370 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Starkey Laboratories, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k192274/ 2020-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k192274-bv-dental-implant-system-fda-510k.jpg K192274 - BV Dental Implant System K192274 is a FDA 510(k) cleared dental medical device. Manufacturer: Bio Concept Co., Ltd.. Cleared Jun 2020. https://www.510kdatabase.net/k192604/ 2020-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k192604-servo-air-40-ventilator-system-fda-510k.jpg K192604 - Servo-air 4.0 Ventilator System K192604 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Maquet Critica Care AB. Cleared Jun 2020. https://www.510kdatabase.net/k193234/ 2020-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k193234-nuvo-if-implant-system-fda-510k.jpg K193234 - NUVO IF Implant System K193234 is a FDA 510(k) cleared dental medical device. Manufacturer: Jjgc Industria E Comercio DE Materiais Dentarios S.A.. Cleared Jun 2020. https://www.510kdatabase.net/k193513/ 2020-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k193513-signafuse-bioactive-bone-graft-fda-510k.jpg K193513 - SIGNAFUSE Bioactive Bone Graft K193513 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Bioventus. Cleared Jun 2020. https://www.510kdatabase.net/k193620/ 2020-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k193620-optomonitor-3-fda-510k.jpg K193620 - OptoMonitor 3 K193620 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Opsens, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k200283/ 2020-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k200283-medussa-pl-cage-fda-510k.jpg K200283 - Medussa-PL Cage K200283 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medyssey USA, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k200297/ 2020-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k200297-microlife-upper-arm-automatic-digital-fda-510k.jpg K200297 - Microlife Upper Arm Automatic Digital Blood Pressure Monitor K200297 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Microlife Intellectual Property GmbH. Cleared Jun 2020. https://www.510kdatabase.net/k200424/ 2020-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k200424-giotto-class-models-3000x-yy-and-4000x-fda-510k.jpg K200424 - Giotto Class (Models - 3000X-YY and 4000X-YY) K200424 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ims Giotto S.P.A.. Cleared Jun 2020. https://www.510kdatabase.net/k200481/ 2020-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k200481-andorate-biopsy-valve-andorate-biopsy-fda-510k.jpg K200481 - Andorate Biopsy Valve, Andorate Biopsy Irrigator K200481 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ga Health Company Limited. Cleared Jun 2020. https://www.510kdatabase.net/k200727/ 2020-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k200727-tens-and-muscle-stimulator-fda-510k.jpg K200727 - TENS and Muscle Stimulator K200727 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Astec Technology Co., Ltd.. Cleared Jun 2020. https://www.510kdatabase.net/k200892/ 2020-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k200892-harveyr-surgical-assistant-fda-510k.jpg K200892 - Harvey(R) Surgical Assistant K200892 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthalign, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k201311/ 2020-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k201311-pf4-igg-assay-fda-510k.jpg K201311 - PF4 IgG assay K201311 is a FDA 510(k) cleared hematology medical device. Manufacturer: Immucor Gti Diagnostics, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k201327/ 2020-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k201327-navlock-trackers-fda-510k.jpg K201327 - NavLock Trackers K201327 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Navigation. Cleared Jun 2020. https://www.510kdatabase.net/k201337/ 2020-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k201337-inpen-system-fda-510k.jpg K201337 - InPen System K201337 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Companion Medical, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k201347/ 2020-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k201347-depuy-attunetotal-knee-system-fda-510k.jpg K201347 - DePuy ATTUNE™ Total Knee System K201347 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k192478/ 2020-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k192478-lt-antibacterial-alginate-with-silver-fda-510k.jpg K192478 - LT Antibacterial Alginate with Silver Dressing K192478 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Zhejiang Longterm Medical Technology Co., Ltd.. Cleared Jun 2020. https://www.510kdatabase.net/k192747/ 2020-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k192747-yxoss-cbr-fda-510k.jpg K192747 - Yxoss CBR® K192747 is a FDA 510(k) cleared dental medical device. Manufacturer: Reoss GmbH. Cleared Jun 2020. https://www.510kdatabase.net/k193253/ 2020-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k193253-infrared-thermometer-model-number-ck-fda-510k.jpg K193253 - Infrared Thermometer, Model Number CK-T1501, CK-T1502, CK-T1503 K193253 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen Changkun Technology Co., Ltd.. Cleared Jun 2020. https://www.510kdatabase.net/k193290/ 2020-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k193290-ai-rad-companion-brain-mr-fda-510k.jpg K193290 - AI-Rad Companion Brain MR K193290 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k193399/ 2020-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k193399-miru-1day-upside-midafilcon-a-fda-510k.jpg K193399 - Miru 1day UpSide (midafilcon A) K193399 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Menicon Co, Ltd.. Cleared Jun 2020. https://www.510kdatabase.net/k200389/ 2020-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k200389-inomax-dsir-plus-fda-510k.jpg K200389 - INOmax DSIR Plus K200389 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Mallinckrodt Manufacturing, LLC. Cleared Jun 2020. https://www.510kdatabase.net/k200875/ 2020-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k200875-artisential-laparoscopic-instruments-fda-510k.jpg K200875 - ArtiSential Laparoscopic Instruments - Electrodes K200875 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Livsmed, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k200921/ 2020-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k200921-qer-fda-510k.jpg K200921 - qER K200921 is a FDA 510(k) cleared radiology medical device. Manufacturer: Qure.Ai Technologies. Cleared Jun 2020. https://www.510kdatabase.net/k201029/ 2020-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k201029-sapphire-spinal-system-sapphire-x-fda-510k.jpg K201029 - Sapphire® Spinal System, Sapphire X Anterior Cervical Plate Spinal System K201029 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinal Elements, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k201220/ 2020-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k201220-aerus-medical-guardianmodel-f170a-fda-510k.jpg K201220 - Aerus Medical Guardian,model F170A K201220 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Aerus Medical, LLC. Cleared Jun 2020. https://www.510kdatabase.net/k201319/ 2020-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k201319-medline-unite-jones-fracture-screw-fda-510k.jpg K201319 - Medline UNITE Jones Fracture Screw System K201319 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medline Industires, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k201322/ 2020-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k201322-entuit-nasal-jejunal-feeding-tube-fda-510k.jpg K201322 - Entuit Nasal Jejunal Feeding Tube K201322 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Wilson-Cook Medical, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k190408/ 2020-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k190408-spinal-fixation-system-fda-510k.jpg K190408 - Spinal Fixation System K190408 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Shangdong Kangsheng Medical Devices Co., Ltd.. Cleared Jun 2020. https://www.510kdatabase.net/k192542/ 2020-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k192542-foot-control-electrosurgical-pencil-fda-510k.jpg K192542 - Foot Control Electrosurgical Pencil, Push Button Electrosurgical Pencil, Rocker Switch Electrosurgical Pencil, Holster, Electorde K192542 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Modern Medical Equipment Manufacturing, Ltd.. Cleared Jun 2020. https://www.510kdatabase.net/k193288/ 2020-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k193288-koya-ripple-fda-510k.jpg K193288 - Koya Ripple K193288 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Koya, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k193540/ 2020-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k193540-trumatch-personalized-solutions-fda-510k.jpg K193540 - TRUMATCH Personalized Solutions K193540 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k200467/ 2020-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k200467-control-iq-technology-fda-510k.jpg K200467 - Control-IQ Technology K200467 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Tandem Diabetes Care, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k201023/ 2020-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k201023-itotal-identity-posterior-stabilized-fda-510k.jpg K201023 - iTotal® Identity Posterior Stabilized Knee Replacement System K201023 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Conformis, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k193376/ 2020-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k193376-visalis-v500-visalis-s500-fda-510k.jpg K193376 - Visalis V500, Visalis S500 K193376 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Carl Zeiss Meditec, AG. Cleared Jun 2020. https://www.510kdatabase.net/k200087/ 2020-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k200087-f3d-cervical-stand-alone-interbody-fda-510k.jpg K200087 - F3D Cervical Stand-Alone Interbody Fusion System K200087 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corelink, LLC. Cleared Jun 2020. https://www.510kdatabase.net/k200508/ 2020-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k200508-pump-in-style-fda-510k.jpg K200508 - Pump In Style K200508 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Medela, LLC. Cleared Jun 2020. https://www.510kdatabase.net/k200899/ 2020-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k200899-quantib-ai-node-fda-510k.jpg K200899 - Quantib AI Node K200899 is a FDA 510(k) cleared radiology medical device. Manufacturer: Quantib B.V.. Cleared Jun 2020. https://www.510kdatabase.net/k201116/ 2020-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k201116-abiomed-23-fr-sheath-fda-510k.jpg K201116 - Abiomed 23 Fr Sheath K201116 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abiomed, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k201313/ 2020-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k201313-cangaroo-envelope-small-cangaroo-fda-510k.jpg K201313 - CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Enevlope (extra extra large) (SubQ) K201313 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aziyo Biologics, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k201481/ 2020-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k201481-centurion-poct-system-fda-510k.jpg K201481 - Centurion POCT System K201481 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthofix, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/den200026/ 2020-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/den200026-endeavorrx-fda-510k.jpg DEN200026 - EndeavorRx DEN200026 is a FDA 510(k) cleared neurology medical device. Manufacturer: Akili Interactive Labs, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k200446/ 2020-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k200446-steris-patient-warming-system-fda-510k.jpg K200446 - STERIS Patient Warming System K200446 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: STERIS Corporation. Cleared Jun 2020. https://www.510kdatabase.net/k192201/ 2020-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k192201-electrical-stimulator-system-fda-510k.jpg K192201 - Electrical Stimulator System K192201 is a FDA 510(k) cleared neurology medical device. Manufacturer: Gymmax Technology Shenzen Co., Ltd.. Cleared Jun 2020. https://www.510kdatabase.net/k193166/ 2020-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k193166-mammomat-revelation-fda-510k.jpg K193166 - MAMMOMAT Revelation K193166 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k193371/ 2020-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k193371-freestyle-libre-2-flash-glucose-fda-510k.jpg K193371 - FreeStyle Libre 2 Flash Glucose Monitoring System K193371 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Diabetes Care, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k193379/ 2020-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k193379-fogarty-arterial-embolectomy-catheter-fda-510k.jpg K193379 - Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe K193379 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Jun 2020. https://www.510kdatabase.net/k200521/ 2020-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k200521-full-automaticnibp-blood-pressure-fda-510k.jpg K200521 - Full Automatic(NIBP) Blood Pressure Monitor K200521 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Health & Life Co., Ltd.. Cleared Jun 2020. https://www.510kdatabase.net/k200683/ 2020-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k200683-inspire-7fm-hollow-fiber-oxygenator-fda-510k.jpg K200683 - INSPIRE 7FM Hollow fiber oxygenator with integrated arterial filter, INSPIRE 7F Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir, INSPIRE 7F DUAL Hollow fiber oxygenator with integrated arterial filter and hardshell reservoir K200683 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sorin Group Italia S.R.L.. Cleared Jun 2020. https://www.510kdatabase.net/k200756/ 2020-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k200756-kubtec-mozart-supra-fda-510k.jpg K200756 - Kubtec Mozart Supra K200756 is a FDA 510(k) cleared radiology medical device. Manufacturer: Kub Technologies, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k200909/ 2020-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k200909-hemo-control-optional-add-pack-hemo-fda-510k.jpg K200909 - Hemo Control (optional Add Pack Hemo Control DM) K200909 is a FDA 510(k) cleared hematology medical device. Manufacturer: Ekf Diagnostic GmbH. Cleared Jun 2020. https://www.510kdatabase.net/k201022/ 2020-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k201022-real-intelligence-cori-cori-fda-510k.jpg K201022 - REAL INTELLIGENCE CORI (CORI) K201022 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Blue Belt Technologies, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k201288/ 2020-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k201288-expansure-large-access-transseptal-fda-510k.jpg K201288 - ExpanSure Large Access Transseptal Dilator K201288 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baylis Medical Company, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k192630/ 2020-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k192630-uws-mi-fda-510k.jpg K192630 - uWS-MI K192630 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Jun 2020. https://www.510kdatabase.net/k193415/ 2020-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k193415-physiq-heart-rhythm-and-respiration-fda-510k.jpg K193415 - physIQ Heart Rhythm and Respiration Module K193415 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Physiq, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k200356/ 2020-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k200356-medo-aria-fda-510k.jpg K200356 - MEDO ARIA K200356 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medo.Ai. Cleared Jun 2020. https://www.510kdatabase.net/k200616/ 2020-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k200616-eeyec-fda-510k.jpg K200616 - E>EyeC K200616 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: E-Swin. Cleared Jun 2020. https://www.510kdatabase.net/k200685/ 2020-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k200685-rigel-3dr-anterior-cervical-interbody-fda-510k.jpg K200685 - RIGEL 3DR Anterior Cervical Interbody Fusion System K200685 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: MiRus, LLC. Cleared Jun 2020. https://www.510kdatabase.net/k200980/ 2020-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k200980-auto-3d-bladder-volume-tool-fda-510k.jpg K200980 - Auto 3D Bladder Volume Tool K200980 is a FDA 510(k) cleared radiology medical device. Manufacturer: Butterfly Network, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k200998/ 2020-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k200998-versana-active-fda-510k.jpg K200998 - Versana Active K200998 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared Jun 2020. https://www.510kdatabase.net/k201007/ 2020-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k201007-in-ka-ureteral-balloon-dilatation-fda-510k.jpg K201007 - In-Ka Ureteral Balloon Dilatation Catheter K201007 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Coloplast Corp.. Cleared Jun 2020. https://www.510kdatabase.net/k201117/ 2020-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k201117-gold-anchor-fda-510k.jpg K201117 - Gold Anchor K201117 is a FDA 510(k) cleared radiology medical device. Manufacturer: Naslund Medical AB. Cleared Jun 2020. https://www.510kdatabase.net/k201271/ 2020-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k201271-benchmark-bmx96-access-system-fda-510k.jpg K201271 - Benchmark BMX96 Access System K201271 is a FDA 510(k) cleared neurology medical device. Manufacturer: Penumbra, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k192003/ 2020-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k192003-auxein-nailing-system-fda-510k.jpg K192003 - Auxein Nailing System K192003 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Auxein Medical Private Limited. Cleared Jun 2020. https://www.510kdatabase.net/k193094/ 2020-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k193094-naviswiss-hip-navigation-system-fda-510k.jpg K193094 - Naviswiss Hip Navigation System K193094 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Naviswiss AG. Cleared Jun 2020. https://www.510kdatabase.net/k200131/ 2020-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k200131-bruxzir-steel-fda-510k.jpg K200131 - BruxZir Steel K200131 is a FDA 510(k) cleared dental medical device. Manufacturer: Prismatik Dentalcraft, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k200487/ 2020-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k200487-raycare-31-fda-510k.jpg K200487 - RayCare 3.1 K200487 is a FDA 510(k) cleared radiology medical device. Manufacturer: RaySearch Laboratories AB (PUBL). Cleared Jun 2020. https://www.510kdatabase.net/k200879/ 2020-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k200879-seaspine-meridian-system-seaspine-fda-510k.jpg K200879 - SeaSpine Meridian System, SeaSpine Regatta Lateral System K200879 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared Jun 2020. https://www.510kdatabase.net/k200972/ 2020-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k200972-hemospray-endoscopic-hemostat-fda-510k.jpg K200972 - Hemospray Endoscopic Hemostat K200972 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wilson-Cook Medical, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k200976/ 2020-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k200976-sr-8230-sr-8230s-portable-x-ray-unit-fda-510k.jpg K200976 - SR-8230, SR-8230S Portable X-ray Unit K200976 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui). Cleared Jun 2020. https://www.510kdatabase.net/k201247/ 2020-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k201247-intraoral-sensor-fda-510k.jpg K201247 - Intraoral Sensor K201247 is a FDA 510(k) cleared radiology medical device. Manufacturer: Dentium Co., Ltd (Ict Branch). Cleared Jun 2020. https://www.510kdatabase.net/k201255/ 2020-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k201255-tsolution-one-total-knee-application-fda-510k.jpg K201255 - TSolution® One Total Knee Application K201255 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: THINK Surgical, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k181813/ 2020-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k181813-immersiveview-surgical-plan-ivsp-fda-510k.jpg K181813 - ImmersiveView Surgical Plan (IVSP®) K181813 is a FDA 510(k) cleared dental medical device. Manufacturer: Immersivetouch. Cleared Jun 2020. https://www.510kdatabase.net/k192033/ 2020-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k192033-contour-p-insert-90-contour-p-insert-fda-510k.jpg K192033 - Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip K192033 is a FDA 510(k) cleared dental medical device. Manufacturer: Bennett Jacoby, Dds, Ms, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k193075/ 2020-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k193075-osteo3-zp-putty-fda-510k.jpg K193075 - Osteo3 ZP Putty K193075 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Sirakoss , Ltd.. Cleared Jun 2020. https://www.510kdatabase.net/k200042/ 2020-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k200042-co2-laser-system-fda-510k.jpg K200042 - CO2 Laser System K200042 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Beijing Superlaser Technology Co., Ltd.. Cleared Jun 2020. https://www.510kdatabase.net/k200753/ 2020-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k200753-ibs-implant-system-ii-fda-510k.jpg K200753 - IBS Implant System II K200753 is a FDA 510(k) cleared dental medical device. Manufacturer: Innobiosurg Co., Ltd.. Cleared Jun 2020. https://www.510kdatabase.net/k200786/ 2020-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k200786-venus-epileve-fda-510k.jpg K200786 - Venus Epileve K200786 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Venus Concept USA, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k201063/ 2020-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k201063-dannik-disposable-monopolar-fda-510k.jpg K201063 - DANNIK Disposable Monopolar Laparoscopic Instrument K201063 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Dannik. Cleared Jun 2020. https://www.510kdatabase.net/k193067/ 2020-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k193067-the-inbone-total-ankle-system-the-fda-510k.jpg K193067 - The INBONE™ Total Ankle System, the INFINITY™ Total Ankle System and the INVISION™ Total Ankle Revision System K193067 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jun 2020. https://www.510kdatabase.net/k193354/ 2020-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k193354-air-compression-therapy-device-fda-510k.jpg K193354 - Air Compression Therapy Device K193354 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Shenzhen Dongjilian Electronics Co., Ltd.. Cleared Jun 2020. https://www.510kdatabase.net/k200015/ 2020-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k200015-epm-series-patient-monitors-fda-510k.jpg K200015 - ePM Series Patient monitors K200015 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Jun 2020. https://www.510kdatabase.net/k200967/ 2020-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k200967-mcarer-powder-free-nitrile-orange-fda-510k.jpg K200967 - mCare(R) Powder Free Nitrile Orange Examination Gloves K200967 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Mercator Medical (Thailand), Ltd.. Cleared Jun 2020. https://www.510kdatabase.net/k191461/ 2020-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k191461-exofin-fusion-skin-closure-system-fda-510k.jpg K191461 - Exofin Fusion Skin Closure System K191461 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Chemence Medical, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k191491/ 2020-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k191491-ez-cover-fda-510k.jpg K191491 - EZ-Cover K191491 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medxpress.Pro. Cleared Jun 2020. https://www.510kdatabase.net/k192550/ 2020-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k192550-3mtm-attesttm-super-rapid-steam-fda-510k.jpg K192550 - 3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid Steam Challenge Pack, 3MTM AttestTM Auto- Readers 490 and 490H K192550 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Jun 2020. https://www.510kdatabase.net/k192952/ 2020-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k192952-spire-health-remote-patient-monitoring-fda-510k.jpg K192952 - Spire Health Remote Patient Monitoring System K192952 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Spire, Inc. D/B/A Spire Health. Cleared Jun 2020. https://www.510kdatabase.net/k192957/ 2020-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k192957-vivachek-blood-glucose-and-b-ketone-fda-510k.jpg K192957 - VivaChek Blood Glucose and B-Ketone Monitoring System K192957 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Vivachek Biotech (Hangzhou) Co., Ltd.. Cleared Jun 2020. https://www.510kdatabase.net/k193003/ 2020-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k193003-nemocast-fda-510k.jpg K193003 - NemoCast K193003 is a FDA 510(k) cleared dental medical device. Manufacturer: Software Nemotec S.L.. Cleared Jun 2020. https://www.510kdatabase.net/k193150/ 2020-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k193150-latex-examination-powder-free-glove-fda-510k.jpg K193150 - Latex Examination Powder Free Glove, Aloe Vera K193150 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Top Glove Sdn. Bhd.. Cleared Jun 2020. https://www.510kdatabase.net/k200107/ 2020-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k200107-epoc-blood-analysis-system-fda-510k.jpg K200107 - epoc Blood Analysis System K200107 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Epocal, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k200398/ 2020-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k200398-axsos-3-af-system-and-axsos-3-ti-system-fda-510k.jpg K200398 - AxSOS 3 AF System and AxSOS 3 Ti System K200398 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker GmbH. Cleared Jun 2020. https://www.510kdatabase.net/k200441/ 2020-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k200441-urolift-advanced-tissue-control-atc-fda-510k.jpg K200441 - UroLift Advanced Tissue Control (ATC) System K200441 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Neotract, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k200615/ 2020-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k200615-signature-one-system-fda-510k.jpg K200615 - Signature ONE System K200615 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthosoft Inc. (d/b/a) Zimmer CAS. Cleared Jun 2020. https://www.510kdatabase.net/k200952/ 2020-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k200952-hummingbird-tympanostomy-tube-system-fda-510k.jpg K200952 - Hummingbird Tympanostomy Tube System K200952 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Preceptis Medical, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k201212/ 2020-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k201212-voyant-open-fusion-device-fda-510k.jpg K201212 - Voyant Open Fusion Device K201212 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Applied Medical Resources Corp.. Cleared Jun 2020. https://www.510kdatabase.net/k193555/ 2020-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k193555-disposable-powder-free-nitrile-fda-510k.jpg K193555 - Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate K193555 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ever Global (Vietnam) Enterprise Corp. Cleared Jun 2020. https://www.510kdatabase.net/k200057/ 2020-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k200057-bioli-lol-delivery-system-fda-510k.jpg K200057 - bioli lOL Delivery System K200057 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Ast Products, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k200104/ 2020-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k200104-oxylight-fda-510k.jpg K200104 - Oxylight K200104 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Raja Trading Company, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k200227/ 2020-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k200227-journey-ii-xr-knee-instrument-fda-510k.jpg K200227 - Journey II XR Knee Instrument K200227 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k200277/ 2020-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k200277-livongo-blood-glucose-monitoring-fda-510k.jpg K200277 - Livongo Blood Glucose Monitoring System (BG1000) K200277 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Livongo Health, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k200883/ 2020-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k200883-carboclear-cervical-plate-system-fda-510k.jpg K200883 - CarboClear® Cervical Plate System K200883 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: CarboFix Orthopedics , Ltd.. Cleared Jun 2020. https://www.510kdatabase.net/k200949/ 2020-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k200949-healix-advance-anchor-with-dynatape-fda-510k.jpg K200949 - HEALIX ADVANCE Anchor with DYNATAPE Suture K200949 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International SARL. Cleared Jun 2020. https://www.510kdatabase.net/k201214/ 2020-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k201214-tslim-x2-insulin-pump-with-fda-510k.jpg K201214 - t:slim X2 Insulin Pump with Interoperable Technology K201214 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Tandem Diabetes Care, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k201223/ 2020-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k201223-lzi-tramadol-enzyme-immunoassay-fda-510k.jpg K201223 - LZI Tramadol Enzyme Immunoassay K201223 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Lin-Zhi International, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k192310/ 2020-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k192310-flap-fixator-burr-hole-cover-fda-510k.jpg K192310 - Flap Fixator, Burr Hole Cover K192310 is a FDA 510(k) cleared neurology medical device. Manufacturer: Ossaware Biotech Co., Ltd.. Cleared Jun 2020. https://www.510kdatabase.net/k193021/ 2020-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k193021-vantage-orian-15t-mrt-1550-v60-fda-510k.jpg K193021 - Vantage Orian 1.5T, MRT-1550, V6.0 K193021 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Jun 2020. https://www.510kdatabase.net/k193226/ 2020-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k193226-altivate-anatomic-canal-sparing-cs-fda-510k.jpg K193226 - AltiVate Anatomic Canal-Sparing (CS) Shoulder K193226 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Encore Medical, L.P.. Cleared Jun 2020. https://www.510kdatabase.net/k200268/ 2020-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k200268-halo-single-loop-snare-kit-fda-510k.jpg K200268 - Halo™ Single-Loop Snare Kit K200268 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Argon Medical Devices, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k200459/ 2020-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k200459-preboa-pro-catheter-fda-510k.jpg K200459 - pREBOA-PRO Catheter K200459 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Prytime Medical Devices, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k200506/ 2020-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k200506-dpp-zika-igm-system-dpp-zika-igm-fda-510k.jpg K200506 - DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader K200506 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Chembio Diagnostic Systems. Cleared Jun 2020. https://www.510kdatabase.net/k200514/ 2020-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k200514-cardioblate-gemini-s-surgical-ablation-fda-510k.jpg K200514 - Cardioblate Gemini-s Surgical Ablation Device K200514 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic. Cleared Jun 2020. https://www.510kdatabase.net/k200602/ 2020-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k200602-premium-cooling-personal-lubricant-fda-510k.jpg K200602 - Premium Cooling Personal Lubricant, Premium Anal Cooling Lubricant K200602 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: CC Wellness, LLC. Cleared Jun 2020. https://www.510kdatabase.net/k200721/ 2020-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k200721-agilis-hispro-steerable-catheter-with-fda-510k.jpg K200721 - Agilis HisPro Steerable Catheter With Electrodes K200721 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott (St. Jude Medical). Cleared Jun 2020. https://www.510kdatabase.net/k200907/ 2020-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k200907-thales-3d-mr-scanner-fda-510k.jpg K200907 - Thales 3D Mr Scanner K200907 is a FDA 510(k) cleared radiology medical device. Manufacturer: Lap GmbH Laser Applikationen. Cleared Jun 2020. https://www.510kdatabase.net/k200929/ 2020-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k200929-hair-growth-system-fda-510k.jpg K200929 - Hair Growth System K200929 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Xuzhou Kernel Medical Equipment Co., Ltd.. Cleared Jun 2020. https://www.510kdatabase.net/k200974/ 2020-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k200974-qlab-advanced-quantification-software-fda-510k.jpg K200974 - QLAB Advanced Quantification Software K200974 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Health Care. Cleared Jun 2020. https://www.510kdatabase.net/k201175/ 2020-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k201175-stealthstation-cranial-software-v130-fda-510k.jpg K201175 - StealthStation Cranial Software v1.3.0 K201175 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Navigation, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k192779/ 2020-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k192779-bunny-wax-personal-lubricant-fda-510k.jpg K192779 - Bunny Wax Personal Lubricant K192779 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Reoxcyn, LLC. Cleared Jun 2020. https://www.510kdatabase.net/k193307/ 2020-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k193307-hip7-fda-510k.jpg K193307 - HIP7 K193307 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Brainlab AG. Cleared Jun 2020. https://www.510kdatabase.net/k193438/ 2020-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k193438-doro-sterile-disposable-skull-pins-fda-510k.jpg K193438 - DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium) K193438 is a FDA 510(k) cleared neurology medical device. Manufacturer: Pro-Med Instruments GmbH. Cleared Jun 2020. https://www.510kdatabase.net/k200089/ 2020-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k200089-fp-evora-nasal-mask-nasal-a-model-fda-510k.jpg K200089 - F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Medium/Large) Sleep Lab Model K200089 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Fisher &Paykel Healthcare , Ltd.. Cleared Jun 2020. https://www.510kdatabase.net/k200322/ 2020-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k200322-altus-spine-pedicle-screw-system-fda-510k.jpg K200322 - Altus Spine Pedicle Screw System K200322 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Altus Partners, LLC. Cleared Jun 2020. https://www.510kdatabase.net/k200528/ 2020-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k200528-bausch-lomb-kalifilcon-a-soft-contact-fda-510k.jpg K200528 - Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism K200528 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Bausch & Lomb, Incorporated. Cleared Jun 2020. https://www.510kdatabase.net/k200532/ 2020-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k200532-starpore-fda-510k.jpg K200532 - StarPore K200532 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Anatomics Pty, Ltd.. Cleared Jun 2020. https://www.510kdatabase.net/k200684/ 2020-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k200684-gastroduodenal-ftrd-set-fda-510k.jpg K200684 - gastroduodenal FTRD Set K200684 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ovesco Endoscopy AG. Cleared Jun 2020. https://www.510kdatabase.net/k200889/ 2020-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k200889-imac-27-pl-40-fda-510k.jpg K200889 - iMac 27 & PL 4.0 K200889 is a FDA 510(k) cleared radiology medical device. Manufacturer: Quantum-Spectra, LLC. Cleared Jun 2020. https://www.510kdatabase.net/k200911/ 2020-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k200911-mira-adapter-fda-510k.jpg K200911 - MIRA Adapter K200911 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Phakos. Cleared Jun 2020. https://www.510kdatabase.net/k201101/ 2020-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k201101-15t-16ch-shoulder-coil-30t-16ch-fda-510k.jpg K201101 - 1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil K201101 is a FDA 510(k) cleared radiology medical device. Manufacturer: Neocoil, LLC. Cleared Jun 2020. https://www.510kdatabase.net/k201202/ 2020-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k201202-mi-viewgo-fda-510k.jpg K201202 - MI View&GO K201202 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k191620/ 2020-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k191620-vitls-platform-fda-510k.jpg K191620 - Vitls Platform K191620 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vitls, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k192601/ 2020-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k192601-uws-mr-fda-510k.jpg K192601 - uWS-MR K192601 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Jun 2020. https://www.510kdatabase.net/k192864/ 2020-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k192864-unifuse-infusion-system-with-cooper-wire-fda-510k.jpg K192864 - UNI*FUSE Infusion System with Cooper Wire K192864 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: AngioDynamics, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k193077/ 2020-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k193077-shiley-adult-flexible-evac-fda-510k.jpg K193077 - Shiley Adult Flexible Evac Tracheostomy Tube with TaperGuard Cuff K193077 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Covidien. Cleared Jun 2020. https://www.510kdatabase.net/k193319/ 2020-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k193319-xycam-ri-xycam-ri-system-xycam-retinal-fda-510k.jpg K193319 - XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System K193319 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Vasoptic Medical, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k193361/ 2020-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k193361-procell-surgical-sponge-blood-recovery-fda-510k.jpg K193361 - ProCell Surgical Sponge-Blood Recovery Unit K193361 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Procell Surgical, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k193577/ 2020-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k193577-sleepright-prorx-custom-dental-guard-fda-510k.jpg K193577 - SleepRight ProRx Custom Dental Guard K193577 is a FDA 510(k) cleared dental medical device. Manufacturer: Splintek, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k200134/ 2020-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k200134-jimushi-sterile-urethral-catheter-for-fda-510k.jpg K200134 - Jimushi Sterile Urethral Catheter for single use K200134 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hangzhou Jimushi Meditech Co., Ltd.. Cleared Jun 2020. https://www.510kdatabase.net/k200536/ 2020-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k200536-3mtm-attesttm-rapid-5-steam-plus-test-fda-510k.jpg K200536 - 3MTM AttestTM Rapid 5 Steam-Plus Test Pack K200536 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Complany. Cleared Jun 2020. https://www.510kdatabase.net/k200538/ 2020-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k200538-skeletal-dynamics-forearm-plating-system-fda-510k.jpg K200538 - Skeletal Dynamics Forearm Plating System K200538 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Skeletal Dynamics, Inc.. Cleared Jun 2020. https://www.510kdatabase.net/k200540/ 2020-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k200540-brainstream-disposable-deep-cup-eeg-fda-510k.jpg K200540 - BRAINSTREAM Disposable Deep Cup EEG Electrodes K200540 is a FDA 510(k) cleared neurology medical device. Manufacturer: Conmed Corporation. Cleared Jun 2020. https://www.510kdatabase.net/k200897/ 2020-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k200897-polyisoprene-powder-free-surgical-fda-510k.jpg K200897 - Polyisoprene Powder Free Surgical Underglove for Use with Chemotherapy Drugs (Blue), Polyisoprene Powder Free Surgical Glove for Use with Chemotherapy Drugs (Natural) K200897 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hartalega Sdn Bhd. Cleared Jun 2020. https://www.510kdatabase.net/k190982/ 2020-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k190982-automatic-digital-blood-pressure-monitor-fda-510k.jpg K190982 - Automatic Digital Blood Pressure Monitor K190982 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Xiamen Ants Bro Technology Co., Ltd.. Cleared May 2020. https://www.510kdatabase.net/k191334/ 2020-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k191334-tek-rmd-tek-robotic-mobilization-fda-510k.jpg K191334 - Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD08 K191334 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Matia Robotics (Us), Inc.. Cleared May 2020. https://www.510kdatabase.net/k192262/ 2020-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k192262-dental-zirconia-blocks-fda-510k.jpg K192262 - Dental Zirconia Blocks K192262 is a FDA 510(k) cleared dental medical device. Manufacturer: De Corematrix Co., Ltd.. Cleared May 2020. https://www.510kdatabase.net/k192420/ 2020-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k192420-crownjun-nylon-suture-fda-510k.jpg K192420 - Crownjun Nylon Suture K192420 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Kono Seisakusho Co., Ltd.. Cleared May 2020. https://www.510kdatabase.net/k193495/ 2020-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k193495-xo-score-percutaneous-transluminal-fda-510k.jpg K193495 - XO Score Percutaneous Transluminal Angioplasty Scoring Catheter K193495 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Transit Scientific. Cleared May 2020. https://www.510kdatabase.net/k193602/ 2020-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k193602-lv-liberty-vision-model-1-90yttrium-fda-510k.jpg K193602 - LV Liberty Vision Model 1 90Yttrium Brachytherapy Source K193602 is a FDA 510(k) cleared radiology medical device. Manufacturer: Lv Liberty Vision Corporation. Cleared May 2020. https://www.510kdatabase.net/k200002/ 2020-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k200002-anterior-spine-truss-system-stand-fda-510k.jpg K200002 - Anterior Spine Truss System – Stand Alone (ASTS-SA) Interbody Fusion Device K200002 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 4Web, Inc.. Cleared May 2020. https://www.510kdatabase.net/k200235/ 2020-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k200235-kong-tl-vbr-system-kong-c-vbr-system-fda-510k.jpg K200235 - KONG-TL VBR System, KONG-C VBR System K200235 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Icotec AG. Cleared May 2020. https://www.510kdatabase.net/k200509/ 2020-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k200509-advia-centaur-vitamin-d-total-vitd-fda-510k.jpg K200509 - ADVIA Centaur Vitamin D Total (VitD) K200509 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared May 2020. https://www.510kdatabase.net/k200511/ 2020-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k200511-rosa-one-brain-application-fda-510k.jpg K200511 - ROSA ONE Brain application K200511 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtech S.A. Cleared May 2020. https://www.510kdatabase.net/k200629/ 2020-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k200629-aspire-mechanical-aspirator-g-fda-510k.jpg K200629 - Aspire Mechanical Aspirator G K200629 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Control Medical Technology. Cleared May 2020. https://www.510kdatabase.net/k200920/ 2020-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k200920-idys-alif-zp-3dti-fda-510k.jpg K200920 - Idys ALIF ZP 3DTi K200920 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Clariance, Sas. Cleared May 2020. https://www.510kdatabase.net/k201172/ 2020-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k201172-cfp-3131-cfp-2222-fda-510k.jpg K201172 - CFP-3131, CFP-2222 K201172 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mx Imaging, Inc.. Cleared May 2020. https://www.510kdatabase.net/k201178/ 2020-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k201178-ilab-polaris-multi-modality-guidance-fda-510k.jpg K201178 - iLab Polaris Multi-Modality Guidance System K201178 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific. Cleared May 2020. https://www.510kdatabase.net/k201189/ 2020-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k201189-stealthstation-s8-spine-software-v130-fda-510k.jpg K201189 - Stealthstation S8 Spine Software v1.3.0 K201189 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Navigation, Inc.. Cleared May 2020. https://www.510kdatabase.net/k192692/ 2020-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k192692-brainomix-360-e-cta-fda-510k.jpg K192692 - Brainomix 360 e-CTA K192692 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainomix Limited. Cleared May 2020. https://www.510kdatabase.net/k192981/ 2020-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k192981-indigo-system-aspiration-catheter-12-fda-510k.jpg K192981 - Indigo System Aspiration Catheter 12, Indigo Aspiration System Separator 12 K192981 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Penumbra, Inc.. Cleared May 2020. https://www.510kdatabase.net/k193539/ 2020-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k193539-revolve-envi-600-advanced-adipose-system-fda-510k.jpg K193539 - REVOLVE ENVI 600 Advanced Adipose System K193539 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lifecell Corporation. Cleared May 2020. https://www.510kdatabase.net/k193665/ 2020-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k193665-frozen-n-fda-510k.jpg K193665 - Frozen N K193665 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Yozma Bmtech Co., Ltd.. Cleared May 2020. https://www.510kdatabase.net/k200116/ 2020-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k200116-picosecond-nd-yag-laser-system-fda-510k.jpg K200116 - PicoSecond Nd: YAG Laser System K200116 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shanghai Apolo Medical Technology Co., Ltd.. Cleared May 2020. https://www.510kdatabase.net/k200885/ 2020-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k200885-meridian-anterior-plate-system-regatta-fda-510k.jpg K200885 - Meridian Anterior Plate System, Regatta Lateral Plate System K200885 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared May 2020. https://www.510kdatabase.net/k200979/ 2020-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k200979-dp-50dp-50tdp-50expertdp-50sdp-50pro-fda-510k.jpg K200979 - DP-50/DP-50T/DP-50Expert/DP-50S/DP-50Pro Digital Ultrasonic Diagnostic Imaging System K200979 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared May 2020. https://www.510kdatabase.net/k201131/ 2020-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k201131-firefly-t-2-fda-510k.jpg K201131 - firefly T-2 K201131 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Firstkind Limited. Cleared May 2020. https://www.510kdatabase.net/k192418/ 2020-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k192418-phacoemulsification-needle-tip-and-fda-510k.jpg K192418 - Phacoemulsification Needle (Tip) and Irrigation Sleeve K192418 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Raico, LLC. Cleared May 2020. https://www.510kdatabase.net/k192449/ 2020-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k192449-joline-kyphoplasty-system-allevo-fda-510k.jpg K192449 - Joline Kyphoplasty System Allevo K192449 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Joline GmbH & Co. KG. Cleared May 2020. https://www.510kdatabase.net/k192652/ 2020-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k192652-trv-fda-510k.jpg K192652 - TRV K192652 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Interacoustics A/S. Cleared May 2020. https://www.510kdatabase.net/k192914/ 2020-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k192914-stimuplex-onvision-system-fda-510k.jpg K192914 - Stimuplex Onvision System K192914 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared May 2020. https://www.510kdatabase.net/k193233/ 2020-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k193233-restoration-modular-hip-system-fda-510k.jpg K193233 - Restoration® Modular Hip System K193233 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp. (Aka Stryker Orthopaedics). Cleared May 2020. https://www.510kdatabase.net/k193336/ 2020-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k193336-synvaza-mouth-sore-and-wound-rinse-fda-510k.jpg K193336 - Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse K193336 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Synedgen, Inc.. Cleared May 2020. https://www.510kdatabase.net/k200253/ 2020-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k200253-megadyne-telescoping-smoke-evacuation-fda-510k.jpg K200253 - Megadyne Telescoping Smoke Evacuation Pencil - 10ft tubing, Megadyne Telescoping Smoke Evacuation Pencil - 15ft tubing, Megadyne Telescoping Smoke Evacuation Soft Tissue Dissector, Megadyne Telescoping Soft Tissue Dissector K200253 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon Endo-Surgery. Cleared May 2020. https://www.510kdatabase.net/k200525/ 2020-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k200525-medical-diode-laser-hair-removal-system-fda-510k.jpg K200525 - Medical Diode Laser Hair Removal System K200525 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Weifang Mingliang Electronics Co., Ltd.. Cleared May 2020. https://www.510kdatabase.net/k200984/ 2020-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k200984-guardian-needle-electrode-fda-510k.jpg K200984 - Guardian Needle Electrode K200984 is a FDA 510(k) cleared neurology medical device. Manufacturer: Rhythmlink International, LLC. Cleared May 2020. https://www.510kdatabase.net/k201112/ 2020-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k201112-ac3-iabp-ac3-optimus-iabp-autocat2-fda-510k.jpg K201112 - AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABP K201112 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Arrow International, Inc.. Cleared May 2020. https://www.510kdatabase.net/k201120/ 2020-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k201120-safecare-multi-drug-urine-test-cup-fda-510k.jpg K201120 - SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card K201120 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Safecare Biotech (Hangzhou) Co., Ltd.. Cleared May 2020. https://www.510kdatabase.net/k181691/ 2020-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k181691-high-speed-air-turbine-handpiece-low-fda-510k.jpg K181691 - High-speed air turbine handpiece / Low-speed air turbine handpiece K181691 is a FDA 510(k) cleared dental medical device. Manufacturer: Foshan Wenjian Medical Instrument Co., Ltd.. Cleared May 2020. https://www.510kdatabase.net/k192392/ 2020-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k192392-diaplus-fda-510k.jpg K192392 - DiaPlus K192392 is a FDA 510(k) cleared dental medical device. Manufacturer: DiaDent Group International. Cleared May 2020. https://www.510kdatabase.net/k193441/ 2020-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k193441-aqua-naina-sterile-saline-solution-fda-510k.jpg K193441 - Aqua Naina Sterile Saline Solution K193441 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Chemtex USA, Inc.. Cleared May 2020. https://www.510kdatabase.net/k193460/ 2020-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k193460-the-inap-one-sleep-therapy-system-fda-510k.jpg K193460 - The iNAP One Sleep Therapy System K193460 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Somnice, Inc.. Cleared May 2020. https://www.510kdatabase.net/k200032/ 2020-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k200032-rewalk-p60-fda-510k.jpg K200032 - ReWalk P6.0 K200032 is a FDA 510(k) cleared neurology medical device. Manufacturer: Re Walk Robotics , Ltd.. Cleared May 2020. https://www.510kdatabase.net/k200305/ 2020-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k200305-npseal-fda-510k.jpg K200305 - NPseal K200305 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Guard Medical, Inc.. Cleared May 2020. https://www.510kdatabase.net/k200944/ 2020-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k200944-uniexpert-2-plus-fda-510k.jpg K200944 - UNIEXPERT 2 PLUS K200944 is a FDA 510(k) cleared radiology medical device. Manufacturer: Adani. Cleared May 2020. https://www.510kdatabase.net/k200988/ 2020-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k200988-maximus-system-fda-510k.jpg K200988 - Maximus System K200988 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Hill-Rom Services Pte, Ltd.. Cleared May 2020. https://www.510kdatabase.net/k201111/ 2020-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k201111-gentlemax-pro-plus-fda-510k.jpg K201111 - GentleMax Pro Plus K201111 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Candela Corporation. Cleared May 2020. https://www.510kdatabase.net/k201118/ 2020-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k201118-exacta-external-drainage-and-fda-510k.jpg K201118 - Exacta External Drainage and Monitoring System, Exacta Pole with Laser Level, Exacta System Replacement Drainage Bag, Replacement Laser Level K201118 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic, Inc.. Cleared May 2020. https://www.510kdatabase.net/k201130/ 2020-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k201130-acuson-juniper-diagnostic-ultrasound-fda-510k.jpg K201130 - ACUSON Juniper Diagnostic Ultrasound System K201130 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 2020. https://www.510kdatabase.net/k190559/ 2020-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k190559-smartport-implantable-ports-smartport-fda-510k.jpg K190559 - SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports K190559 is a FDA 510(k) cleared general hospital medical device. Manufacturer: AngioDynamics, Inc.. Cleared May 2020. https://www.510kdatabase.net/k191847/ 2020-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k191847-adeor-medical-nxt-non-stick-bipolar-fda-510k.jpg K191847 - Adeor Medical nxt Non-stick Bipolar Forceps, Adeor Medical nxt Single-Use Non-stick Bipolar Forceps K191847 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Adeor Medical AG. Cleared May 2020. https://www.510kdatabase.net/k192488/ 2020-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k192488-co2-sidestream-module-fda-510k.jpg K192488 - CO2 Sidestream Module K192488 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Beijing Kingst Commercial & Trade Co., Ltd.. Cleared May 2020. https://www.510kdatabase.net/k192560/ 2020-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k192560-surgical-gown-fda-510k.jpg K192560 - Surgical Gown K192560 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shandong Kangli Medical Equipment Technology Co., Ltd.. Cleared May 2020. https://www.510kdatabase.net/k193423/ 2020-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k193423-vaderone-pedicle-system-mis-and-fda-510k.jpg K193423 - VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 K193423 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Icotec AG. Cleared May 2020. https://www.510kdatabase.net/k200126/ 2020-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k200126-verify-assert-self-contained-fda-510k.jpg K200126 - VERIFY Assert Self-Contained Biological Indicator K200126 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared May 2020. https://www.510kdatabase.net/k200246/ 2020-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k200246-jps-juniortho-plating-system-fda-510k.jpg K200246 - JPS JuniOrtho Plating System K200246 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthofix Srl. Cleared May 2020. https://www.510kdatabase.net/k200410/ 2020-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k200410-reconnaissance-pv-018-otw-digital-ivus-fda-510k.jpg K200410 - Reconnaissance PV .018 OTW Digital IVUS Catheter K200410 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Philips Image Guided Therapy Corporation. Cleared May 2020. https://www.510kdatabase.net/k200419/ 2020-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k200419-kalera-vacuum-aspiration-catheter-k-vac-fda-510k.jpg K200419 - Kalera Vacuum Aspiration Catheter (K-VAC) K200419 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Kalera Medical, Inc.. Cleared May 2020. https://www.510kdatabase.net/k200457/ 2020-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k200457-premium-warming-personal-lubricant-fda-510k.jpg K200457 - Premium Warming Personal Lubricant, Premium Anal Warming Lubricant, All-In-One Warming K200457 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: CC Wellness, LLC. Cleared May 2020. https://www.510kdatabase.net/k200936/ 2020-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k200936-invictus-ct-spinal-fixation-system-fda-510k.jpg K200936 - Invictus™ CT Spinal Fixation System K200936 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine, Inc.. Cleared May 2020. https://www.510kdatabase.net/den190037/ 2020-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/den190037-navicam-capsule-endoscope-system-with-fda-510k.jpg DEN190037 - NaviCam Capsule Endoscope System with NaviCam Stomach Capsule DEN190037 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Anx Robotica, Inc.. Cleared May 2020. https://www.510kdatabase.net/k191512/ 2020-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k191512-lotuscatheter-lotus-no-balloon-catheter-fda-510k.jpg K191512 - LotusCatheter (Lotus No Balloon Catheter) K191512 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hakki Medical Technologies, Inc.. Cleared May 2020. https://www.510kdatabase.net/k192265/ 2020-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k192265-gi-4000-electrosurgical-generator-fda-510k.jpg K192265 - gi-4000 Electrosurgical Generator K192265 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Endoscopy Group, Inc.. Cleared May 2020. https://www.510kdatabase.net/k192342/ 2020-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k192342-electrosurgical-system-electrosurgical-fda-510k.jpg K192342 - Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories) K192342 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hangzhou AGS MedTech Co., Ltd.. Cleared May 2020. https://www.510kdatabase.net/k192446/ 2020-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k192446-co2-mainstream-module-fda-510k.jpg K192446 - CO2 Mainstream Module K192446 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Beijing Kingst Commercial & Trade Co., Ltd.. Cleared May 2020. https://www.510kdatabase.net/k192879/ 2020-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k192879-acclarix-ax8-diagnostic-ultrasound-fda-510k.jpg K192879 - Acclarix AX8 Diagnostic Ultrasound System / Acclarix LX9 Series Diagnostic Ultrasound System K192879 is a FDA 510(k) cleared radiology medical device. Manufacturer: Edan Instruments, Inc.. Cleared May 2020. https://www.510kdatabase.net/k193391/ 2020-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k193391-benevision-central-monitoring-system-fda-510k.jpg K193391 - BeneVision Central Monitoring System K193391 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared May 2020. https://www.510kdatabase.net/k200252/ 2020-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k200252-getinge-assured-mi-steam-migrating-fda-510k.jpg K200252 - Getinge Assured MI Steam Migrating Integrator K200252 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Steritec Products Mfg Co, Inc.. Cleared May 2020. https://www.510kdatabase.net/k200274/ 2020-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k200274-caricloud-fda-510k.jpg K200274 - CariCloud K200274 is a FDA 510(k) cleared radiology medical device. Manufacturer: Caristo Diagnostics. Cleared May 2020. https://www.510kdatabase.net/k200400/ 2020-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k200400-systane-ilux2-fda-510k.jpg K200400 - Systane iLux2 K200400 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Tear Film Innovations, Inc.. Cleared May 2020. https://www.510kdatabase.net/k200468/ 2020-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k200468-v30-system-v20-system-v10-system-v-fc-fda-510k.jpg K200468 - V30 system, V20 system, V10 system, V-FC Handpiece K200468 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Viora , Ltd.. Cleared May 2020. https://www.510kdatabase.net/k200483/ 2020-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k200483-spyglass-discover-digital-catheter-fda-510k.jpg K200483 - SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller K200483 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Boston Scientific Corporation. Cleared May 2020. https://www.510kdatabase.net/k200662/ 2020-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k200662-x-guide-surgical-navigation-system-fda-510k.jpg K200662 - X-Guide® Surgical Navigation System K200662 is a FDA 510(k) cleared dental medical device. Manufacturer: X-Nav Technologies, LLC. Cleared May 2020. https://www.510kdatabase.net/k200737/ 2020-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k200737-spy-portable-handheld-imaging-spy-phi-fda-510k.jpg K200737 - SPY Portable Handheld Imaging (SPY-PHI) System K200737 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Novadaq Technologies Ulc. (Now A Part of Stryker). Cleared May 2020. https://www.510kdatabase.net/k200751/ 2020-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k200751-photodynamic-therapy-pdt-equipment-fda-510k.jpg K200751 - Photodynamic Therapy (PDT) Equipment K200751 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shangdong Huamei Technology Co., Ltd.. Cleared May 2020. https://www.510kdatabase.net/k200956/ 2020-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k200956-nuvasive-thoracolumbar-plates-fda-510k.jpg K200956 - NuVasive Thoracolumbar Plates K200956 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared May 2020. https://www.510kdatabase.net/k200969/ 2020-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k200969-nexxt-matrixx-system-fda-510k.jpg K200969 - NEXXT MATRIXX System K200969 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nexxt Spine, LLC. Cleared May 2020. https://www.510kdatabase.net/k200995/ 2020-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k200995-insignia-anterior-cervical-plate-system-fda-510k.jpg K200995 - Insignia™ Anterior Cervical Plate System K200995 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine, Inc.. Cleared May 2020. https://www.510kdatabase.net/k201068/ 2020-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k201068-affinity-cp-centrifugal-blood-pump-fda-510k.jpg K201068 - Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortiva BioActive Surface K201068 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared May 2020. https://www.510kdatabase.net/k201086/ 2020-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k201086-advincula-delineator-uterine-manipulator-fda-510k.jpg K201086 - Advincula Delineator Uterine Manipulator K201086 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: CooperSurgical, Inc.. Cleared May 2020. https://www.510kdatabase.net/k201106/ 2020-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k201106-intramarx-3d-radiopaque-marker-fda-510k.jpg K201106 - IntraMarX 3D Radiopaque Marker K201106 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Anx Robotica Corp. Cleared May 2020. https://www.510kdatabase.net/k191362/ 2020-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k191362-lifeflow-blood-system-fda-510k.jpg K191362 - LifeFlow Blood System K191362 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 410 Medical, Inc.. Cleared May 2020. https://www.510kdatabase.net/k192399/ 2020-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k192399-infinity-angioplasty-balloon-catheter-fda-510k.jpg K192399 - Infinity Angioplasty Balloon Catheter K192399 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Infinity Angioplasty Balloon Company, LLC. Cleared May 2020. https://www.510kdatabase.net/k192727/ 2020-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k192727-k-assay-r-rf-ver2-k-assay-r-rf-fda-510k.jpg K192727 - K-ASSAY (R) RF (Ver.2), K-ASSAY (R) RF Calibrator (Ver.2) K192727 is a FDA 510(k) cleared immunology medical device. Manufacturer: Kamiya Biomedical Company. Cleared May 2020. https://www.510kdatabase.net/k200352/ 2020-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k200352-axis-spine-technologies-alif-fda-510k.jpg K200352 - Axis Spine Technologies ALIF K200352 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Axis Spine Technologies, Ltd.. Cleared May 2020. https://www.510kdatabase.net/k200860/ 2020-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k200860-hanarostent-esophagus-tts-ccc-fda-510k.jpg K200860 - HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN) K200860 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: M.I. Tech Co., Ltd.. Cleared May 2020. https://www.510kdatabase.net/k201078/ 2020-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k201078-nuvasive-acp-system-fda-510k.jpg K201078 - NuVasive® ACP System K201078 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared May 2020. https://www.510kdatabase.net/k192016/ 2020-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k192016-smoov-o10-fda-510k.jpg K192016 - SMOOV O10 K192016 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Alber GmbH. Cleared May 2020. https://www.510kdatabase.net/k200303/ 2020-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k200303-reform-pedicle-screw-system-fda-510k.jpg K200303 - Reform Pedicle Screw System K200303 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Precision Spine. Cleared May 2020. https://www.510kdatabase.net/k200749/ 2020-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k200749-cubescan-biocon-900s-fda-510k.jpg K200749 - CUBEScan BioCon-900S K200749 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mcube Technology Co., Ltd.. Cleared May 2020. https://www.510kdatabase.net/k200864/ 2020-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k200864-5mp-color-lcd-monitors-c53s-c53sp-5mp-fda-510k.jpg K200864 - 5MP Color LCD Monitors C53S+, C53SP+, 5MP Monochrome LCD Monitors G53S+, G53SP+ K200864 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Beacon Display Technology Co., Ltd.. Cleared May 2020. https://www.510kdatabase.net/k201124/ 2020-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k201124-topaz-mobile-dr-system-fda-510k.jpg K201124 - TOPAZ Mobile DR System K201124 is a FDA 510(k) cleared radiology medical device. Manufacturer: DRGEM Corporation. Cleared May 2020. https://www.510kdatabase.net/k191906/ 2020-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k191906-mirus-3d-printed-lumbar-interbody-fda-510k.jpg K191906 - MiRus 3D Printed Lumbar Interbody Fusion Systems consisting of the Callisto 3D Printed PLIF, HYPERION 3D Printed TLIF, CALYPSO 3D Printed LLIF, and ANTARES 3D Printed ALIF K191906 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: MiRus, LLC. Cleared May 2020. https://www.510kdatabase.net/k193404/ 2020-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k193404-ufii-bar-holder-abutment-fda-510k.jpg K193404 - UF(II) Bar holder abutment K193404 is a FDA 510(k) cleared dental medical device. Manufacturer: Dio Corporation. Cleared May 2020. https://www.510kdatabase.net/k193553/ 2020-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k193553-varseosmile-temp-fda-510k.jpg K193553 - VarseoSmile Temp K193553 is a FDA 510(k) cleared dental medical device. Manufacturer: Bego Bremer Goldschlagerei Wilh. Herbst GmbH & Co. KG. Cleared May 2020. https://www.510kdatabase.net/k200056/ 2020-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k200056-catalys-precision-laser-system-fda-510k.jpg K200056 - Catalys Precision Laser System K200056 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Amo Manufacturng USA, LLC. Cleared May 2020. https://www.510kdatabase.net/k200390/ 2020-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k200390-vac-dermatac-drape-fda-510k.jpg K200390 - V.A.C. DERMATAC Drape K200390 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Kci USA, Inc.. Cleared May 2020. https://www.510kdatabase.net/k200431/ 2020-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k200431-3d-graftrasp-system-fda-510k.jpg K200431 - 3D GraftRasp System K200431 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Surgentec. Cleared May 2020. https://www.510kdatabase.net/k200878/ 2020-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k200878-natus-neuroworks-fda-510k.jpg K200878 - Natus NeuroWorks K200878 is a FDA 510(k) cleared neurology medical device. Manufacturer: Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). Cleared May 2020. https://www.510kdatabase.net/k201062/ 2020-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k201062-syngo-ultrasound-apps-suite-susas-fda-510k.jpg K201062 - syngo Ultrasound Apps Suite (sUSAS) K201062 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 2020. https://www.510kdatabase.net/k200866/ 2020-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k200866-aptima-combo-2-assay-panther-system-fda-510k.jpg K200866 - Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System) K200866 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Hologic, Inc.. Cleared May 2020. https://www.510kdatabase.net/k191745/ 2020-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k191745-medtronic-commander-flex-fda-510k.jpg K191745 - Medtronic Commander Flex K191745 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Care Management Services. Cleared May 2020. https://www.510kdatabase.net/k193058/ 2020-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k193058-sonarmed-airwave-airway-monitoring-fda-510k.jpg K193058 - SonarMed AirWave Airway Monitoring System K193058 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sonarmed, Inc.. Cleared May 2020. https://www.510kdatabase.net/k193122/ 2020-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k193122-biocore9-humeral-resurfacing-system-fda-510k.jpg K193122 - Biocore9 Humeral Resurfacing System K193122 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biocore9, LLC. Cleared May 2020. https://www.510kdatabase.net/k193334/ 2020-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k193334-pristina-serena-bright-fda-510k.jpg K193334 - Pristina Serena Bright K193334 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared May 2020. https://www.510kdatabase.net/k200287/ 2020-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k200287-bp-bt-kiosk-fda-510k.jpg K200287 - BP-BT Kiosk K200287 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ld Technology, LLC. Cleared May 2020. https://www.510kdatabase.net/k200479/ 2020-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k200479-aquapulse-auxiliary-water-connector-fda-510k.jpg K200479 - AquaPulse Auxiliary Water Connector K200479 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ga Health Company Limited. Cleared May 2020. https://www.510kdatabase.net/k200746/ 2020-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k200746-ipl-treatment-systems-fda-510k.jpg K200746 - IPL Treatment Systems K200746 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shanghai Apolo Medical Technology Co., Ltd.. Cleared May 2020. https://www.510kdatabase.net/k200747/ 2020-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k200747-purilens-plus-preservative-free-saline-fda-510k.jpg K200747 - PuriLens Plus Preservative Free Saline K200747 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: The Lifestyle Company, Inc.. Cleared May 2020. https://www.510kdatabase.net/k191819/ 2020-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k191819-ag-foam-dressing-non-adhesive-ag-foam-fda-510k.jpg K191819 - Ag Foam Dressing Non-Adhesive, Ag Foam Dressing Adhesive, Silicone Ag Foam Dressing, Silicone Ag Foam Dressing with Border K191819 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Winner Medical Co., Ltd.. Cleared May 2020. https://www.510kdatabase.net/k191826/ 2020-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k191826-keyi-total-hip-system-fda-510k.jpg K191826 - KeYi Total Hip System K191826 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Beijing Keyi Medical Device Technology Co., Ltd.. Cleared May 2020. https://www.510kdatabase.net/k192048/ 2020-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k192048-single-use-endoscope-valves-set-fda-510k.jpg K192048 - Single Use Endoscope Valves Set K192048 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Anrei Medical (Hangzhou) Co., Ltd.. Cleared May 2020. https://www.510kdatabase.net/k192463/ 2020-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k192463-phmb-foam-dressing-non-adhesive-phmb-fda-510k.jpg K192463 - PHMB Foam Dressing Non-Adhesive, PHMB Foam Dressing Adhesive, Silicone PHMB Foam Dressing, Silicone PHMB Foam Dressing with Border K192463 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Winner Medical Co., Ltd.. Cleared May 2020. https://www.510kdatabase.net/k192694/ 2020-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k192694-pal-single-use-cannulas-fda-510k.jpg K192694 - PAL Single-Use Cannulas K192694 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Microaire Surgical Instruments. Cleared May 2020. https://www.510kdatabase.net/k193096/ 2020-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k193096-sin-dental-implant-system-fda-510k.jpg K193096 - S.I.N. Dental Implant System K193096 is a FDA 510(k) cleared dental medical device. Manufacturer: S.I.N. ? Sistema DE Implante Nacional S.A.. Cleared May 2020. https://www.510kdatabase.net/k193293/ 2020-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k193293-xv-lung-ventilation-analysis-software-fda-510k.jpg K193293 - XV Lung Ventilation Analysis Software K193293 is a FDA 510(k) cleared radiology medical device. Manufacturer: 4Dx Limited. Cleared May 2020. https://www.510kdatabase.net/k193436/ 2020-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k193436-vita-ambria-fda-510k.jpg K193436 - VITA Ambria K193436 is a FDA 510(k) cleared dental medical device. Manufacturer: Vita Zahnfabrik GmbH H Rauter & CO. Cleared May 2020. https://www.510kdatabase.net/k200169/ 2020-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k200169-vfs1-bipolar-electrosurgical-generator-fda-510k.jpg K200169 - VFS1 Bipolar Electrosurgical Generator K200169 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: FHC, Inc.. Cleared May 2020. https://www.510kdatabase.net/k200317/ 2020-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k200317-support-catheter-fda-510k.jpg K200317 - Support Catheter K200317 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Qxmedical, LLC. Cleared May 2020. https://www.510kdatabase.net/k200367/ 2020-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k200367-distal-humerus-plating-system-fda-510k.jpg K200367 - Distal Humerus Plating System K200367 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Skeletal Dynamics, Inc.. Cleared May 2020. https://www.510kdatabase.net/k200700/ 2020-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k200700-surmodics-sublime-radial-access-014-rx-fda-510k.jpg K200700 - Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter K200700 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Creagh Medical, Ltd.. Cleared May 2020. https://www.510kdatabase.net/k200701/ 2020-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k200701-skeletal-dynamics-midshaft-humerus-fda-510k.jpg K200701 - Skeletal Dynamics Midshaft Humerus Plating System K200701 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Skeletal Dynamics, Inc.. Cleared May 2020. https://www.510kdatabase.net/k200989/ 2020-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k200989-reliance-endoscope-processing-system-fda-510k.jpg K200989 - Reliance Endoscope Processing System K200989 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared May 2020. https://www.510kdatabase.net/k200997/ 2020-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k200997-lumipulse-g-ca19-9-n-fda-510k.jpg K200997 - Lumipulse G CA19-9-N K200997 is a FDA 510(k) cleared immunology medical device. Manufacturer: Fujirebio Diagnostics,Inc.. Cleared May 2020. https://www.510kdatabase.net/k201034/ 2020-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k201034-syngoct-cascoring-fda-510k.jpg K201034 - Syngo.CT CaScoring K201034 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 2020. https://www.510kdatabase.net/k201053/ 2020-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k201053-percunav-image-fusion-and-fda-510k.jpg K201053 - PercuNav Image Fusion and Interventional Navigation K201053 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Ultrasound, Inc.. Cleared May 2020. https://www.510kdatabase.net/k190118/ 2020-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k190118-dr-hos-foot-pad-electrode-models-dhfre-fda-510k.jpg K190118 - Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III) K190118 is a FDA 510(k) cleared neurology medical device. Manufacturer: Guangzhou Xinbo Electronic Co., Ltd.. Cleared May 2020. https://www.510kdatabase.net/k192642/ 2020-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k192642-308nm-excimer-system-fda-510k.jpg K192642 - 308nm Excimer System K192642 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Chongqing Peninsula Medical Technology Co., Ltd.. Cleared May 2020. https://www.510kdatabase.net/k193055/ 2020-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k193055-purzir-dental-zirconia-fda-510k.jpg K193055 - Purzir Dental Zirconia K193055 is a FDA 510(k) cleared dental medical device. Manufacturer: 3DBiocad. Cleared May 2020. https://www.510kdatabase.net/k200124/ 2020-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k200124-incore-mpj-system-fda-510k.jpg K200124 - InCore MPJ System K200124 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nextremity Solutions, Inc.. Cleared May 2020. https://www.510kdatabase.net/k200205/ 2020-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k200205-reprocessed-advisor-fl-circular-fda-510k.jpg K200205 - Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled K200205 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Stryker Sustainability Solutions. Cleared May 2020. https://www.510kdatabase.net/k200782/ 2020-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k200782-triathlon-posterior-stabilized-femoral-fda-510k.jpg K200782 - Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-Apatite K200782 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared May 2020. https://www.510kdatabase.net/k200991/ 2020-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k200991-evol-spinal-interbody-system-fda-510k.jpg K200991 - EVOL Spinal Interbody System K200991 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Cutting Edge Spine, LLC. Cleared May 2020. https://www.510kdatabase.net/k201011/ 2020-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k201011-medtronic-model-5392-external-pulse-fda-510k.jpg K201011 - Medtronic Model 5392 External Pulse Generator (EPG) K201011 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared May 2020. https://www.510kdatabase.net/k192222/ 2020-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k192222-ez-inject-single-use-needle-fda-510k.jpg K192222 - EZ-Inject Single use Needle K192222 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Poonglim Pharmatech, Inc.. Cleared May 2020. https://www.510kdatabase.net/k192901/ 2020-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k192901-healthvcf-fda-510k.jpg K192901 - HealthVCF K192901 is a FDA 510(k) cleared radiology medical device. Manufacturer: Zebra Medical Vision, Ltd.. Cleared May 2020. https://www.510kdatabase.net/k192930/ 2020-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k192930-dymaxeon-spine-system-fda-510k.jpg K192930 - Dymaxeon Spine System K192930 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Back 2 Basics Direct, LLC. Cleared May 2020. https://www.510kdatabase.net/k193457/ 2020-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k193457-audere-lumbar-spacer-system-fda-510k.jpg K193457 - AUDERE Lumbar Spacer System K193457 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Met One Technologies. Cleared May 2020. https://www.510kdatabase.net/k200026/ 2020-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k200026-disposable-ecg-cable-fda-510k.jpg K200026 - Disposable ECG Cable K200026 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Changke Connect Electronics Co., Ltd.. Cleared May 2020. https://www.510kdatabase.net/k201043/ 2020-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k201043-wireless-digital-flat-panel-detector-fda-510k.jpg K201043 - Wireless Digital Flat Panel Detector (Model: Mars1717V-VSI, Mano4343W) K201043 is a FDA 510(k) cleared radiology medical device. Manufacturer: Iray Technology Taicang , Ltd.. Cleared May 2020. https://www.510kdatabase.net/k201136/ 2020-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k201136-cure-lumbar-plate-system-fda-510k.jpg K201136 - Cure™ Lumbar Plate System K201136 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Meditech Spine, LLC. Cleared May 2020. https://www.510kdatabase.net/k192103/ 2020-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k192103-thunderbeat-open-fine-jaw-type-x-hand-fda-510k.jpg K192103 - Thunderbeat Open Fine Jaw Type X Hand Instrument K192103 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared May 2020. https://www.510kdatabase.net/k192244/ 2020-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k192244-arcad-smilestudio-and-aligner-system-fda-510k.jpg K192244 - Arcad SmileStudio and Aligner System K192244 is a FDA 510(k) cleared dental medical device. Manufacturer: Arcadlab. Cleared May 2020. https://www.510kdatabase.net/k193043/ 2020-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k193043-critical-alert-commonpath-enterprise-fda-510k.jpg K193043 - Critical Alert CommonPath Enterprise K193043 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Critical Alert. Cleared May 2020. https://www.510kdatabase.net/k193085/ 2020-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k193085-puraderm-gel-fda-510k.jpg K193085 - PuraDERM Gel K193085 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3-D Matrix, Inc.. Cleared May 2020. https://www.510kdatabase.net/k200213/ 2020-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k200213-biograph-mmr-with-syngo-mr-e11p-ap01-fda-510k.jpg K200213 - Biograph mMR with syngo MR E11P-AP01 system software K200213 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 2020. https://www.510kdatabase.net/k200290/ 2020-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k200290-resorbable-mesh-pouch-ballast-mt-fda-510k.jpg K200290 - Resorbable Mesh Pouch (Ballast MT, OsteoBallast MT) K200290 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared May 2020. https://www.510kdatabase.net/k200501/ 2020-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k200501-artisential-laparoscopic-instrument-fda-510k.jpg K200501 - ArtiSential Laparoscopic Instrument-Electrodes K200501 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Livsmed, Inc.. Cleared May 2020. https://www.510kdatabase.net/k200841/ 2020-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k200841-harmonic-1100-shears-20cm-length-fda-510k.jpg K200841 - Harmonic 1100 Shears, 20cm length, Harmonic 1100 36cm length, Generator G11 K200841 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon Endo-Surgery, LLC. Cleared May 2020. https://www.510kdatabase.net/den190031/ 2020-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/den190031-np-screen-fda-510k.jpg DEN190031 - NP Screen DEN190031 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Advance Sentry Corporation. Cleared May 2020. https://www.510kdatabase.net/k200659/ 2020-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k200659-dermalux-tri-wave-md-fda-510k.jpg K200659 - Dermalux Tri-Wave MD K200659 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesthetic Technology, Ltd.. Cleared May 2020. https://www.510kdatabase.net/k192209/ 2020-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k192209-citrasate-dry-acid-concentrate-fda-510k.jpg K192209 - Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate K192209 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC. Cleared May 2020. https://www.510kdatabase.net/k192218/ 2020-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k192218-custom-legacy-and-custom-interactive-fda-510k.jpg K192218 - Custom Legacy and Custom InterActive Titanium Abutments K192218 is a FDA 510(k) cleared dental medical device. Manufacturer: Implant Direct Sybron Manufacturing, LLC. Cleared May 2020. https://www.510kdatabase.net/k193016/ 2020-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k193016-precice-bone-transport-system-fda-510k.jpg K193016 - PRECICE Bone Transport System K193016 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nuvasive Specialized Orthopedics, Inc.. Cleared May 2020. https://www.510kdatabase.net/k193617/ 2020-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k193617-precice-screws-fda-510k.jpg K193617 - Precice® Screws K193617 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nuvasive Specialized Orthopedics, Inc.. Cleared May 2020. https://www.510kdatabase.net/k200348/ 2020-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k200348-neocis-guidance-system-ngs-with-fda-510k.jpg K200348 - Neocis Guidance System (NGS) with Fiducial Array Splint (FAS) K200348 is a FDA 510(k) cleared dental medical device. Manufacturer: Neocis, Inc.. Cleared May 2020. https://www.510kdatabase.net/k200640/ 2020-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k200640-altapore-shape-fda-510k.jpg K200640 - ALTAPORE SHAPE K200640 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Baxter Healthcare Corporation. Cleared May 2020. https://www.510kdatabase.net/k200935/ 2020-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k200935-mazor-x-fda-510k.jpg K200935 - Mazor X K200935 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Mazor Robotics , Ltd.. Cleared May 2020. https://www.510kdatabase.net/k200950/ 2020-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k200950-ventricular-catheter-fda-510k.jpg K200950 - Ventricular Catheter K200950 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared May 2020. https://www.510kdatabase.net/k200961/ 2020-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k200961-treace-medical-concepts-tmc-plating-fda-510k.jpg K200961 - Treace Medical Concepts (TMC) Plating System K200961 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Treace Medical Concepts, Inc.. Cleared May 2020. https://www.510kdatabase.net/k200964/ 2020-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k200964-sonosite-px-ultrasound-system-fda-510k.jpg K200964 - Sonosite PX Ultrasound System K200964 is a FDA 510(k) cleared radiology medical device. Manufacturer: FUJIFILM Sonosite, Inc.. Cleared May 2020. https://www.510kdatabase.net/k192577/ 2020-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k192577-actreen-hi-lite-intermittent-urinary-fda-510k.jpg K192577 - Actreen Hi-Lite Intermittent Urinary Catheters K192577 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: B.Braun Medical, Inc.. Cleared May 2020. https://www.510kdatabase.net/k192651/ 2020-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k192651-zaga-zygomatic-system-fda-510k.jpg K192651 - ZAGA Zygomatic System K192651 is a FDA 510(k) cleared dental medical device. Manufacturer: Southern Implants (Pty), Ltd.. Cleared May 2020. https://www.510kdatabase.net/k192693/ 2020-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k192693-nuvo-nano-portable-oxygen-concentrator-fda-510k.jpg K192693 - Nuvo Nano Portable Oxygen Concentrator K192693 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Nidek Medical Products, Inc.. Cleared May 2020. https://www.510kdatabase.net/k192866/ 2020-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k192866-chemfort-cstd-fda-510k.jpg K192866 - Chemfort CSTD K192866 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Simplivia Healthcare , Ltd.. Cleared May 2020. https://www.510kdatabase.net/k192972/ 2020-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k192972-patient-monitor-fda-510k.jpg K192972 - Patient Monitor K192972 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared May 2020. https://www.510kdatabase.net/k193535/ 2020-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k193535-ezer-portable-x-ray-system-fda-510k.jpg K193535 - EZER, Portable X-ray System K193535 is a FDA 510(k) cleared radiology medical device. Manufacturer: Livermoretech, Inc.. Cleared May 2020. https://www.510kdatabase.net/k200120/ 2020-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k200120-litesaber-wire-torque-assist-device-fda-510k.jpg K200120 - LiteSaber Wire Torque Assist Device K200120 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vesatek, LLC. Cleared May 2020. https://www.510kdatabase.net/k200146/ 2020-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k200146-het-bipolar-electrocautery-forceps-het-fda-510k.jpg K200146 - HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery Monitor K200146 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien, LLC. Cleared May 2020. https://www.510kdatabase.net/k200395/ 2020-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k200395-lospa-ii-knee-system-exult-knee-fda-510k.jpg K200395 - LOSPA II Knee System (EXULT Knee Replacement System) K200395 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corentec Co., Ltd.. Cleared May 2020. https://www.510kdatabase.net/k200435/ 2020-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k200435-catalyst-catalyst-hd-fda-510k.jpg K200435 - Catalyst+, Catalyst+ HD K200435 is a FDA 510(k) cleared radiology medical device. Manufacturer: C-Rad Positioning AB. Cleared May 2020. https://www.510kdatabase.net/k200512/ 2020-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k200512-etest-plazomicin-plz-0016-256-gml-fda-510k.jpg K200512 - ETEST Plazomicin (PLZ) (0.016-256 µg/mL) K200512 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Biom?rieux SA. Cleared May 2020. https://www.510kdatabase.net/k200653/ 2020-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k200653-amf-revision-tt-cones-fda-510k.jpg K200653 - AMF Revision TT Cones K200653 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Lima Corporate S.P.A.. Cleared May 2020. https://www.510kdatabase.net/k200699/ 2020-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k200699-hs70a-diagnostic-ultrasound-system-fda-510k.jpg K200699 - HS70A Diagnostic Ultrasound System K200699 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Medison Co., Ltd.. Cleared May 2020. https://www.510kdatabase.net/k200966/ 2020-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k200966-icare-home-tonometer-fda-510k.jpg K200966 - Icare HOME Tonometer K200966 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Icare Finland OY. Cleared May 2020. https://www.510kdatabase.net/k192069/ 2020-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k192069-aerodentis-system-fda-510k.jpg K192069 - Aerodentis System K192069 is a FDA 510(k) cleared dental medical device. Manufacturer: Dror Orthodesign. Cleared May 2020. https://www.510kdatabase.net/k192283/ 2020-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k192283-medron-vessel-dilator-6f-x-22cm-hdpe-fda-510k.jpg K192283 - MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator K192283 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medron, LLC. Cleared May 2020. https://www.510kdatabase.net/k192586/ 2020-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k192586-liaison-folate-fda-510k.jpg K192586 - LIAISON® Folate K192586 is a FDA 510(k) cleared chemistry medical device. Manufacturer: DiaSorin, Inc.. Cleared May 2020. https://www.510kdatabase.net/k193189/ 2020-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k193189-rfid-localization-system-fda-510k.jpg K193189 - RFID Localization System K193189 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Health Beacons, Inc.. Cleared May 2020. https://www.510kdatabase.net/k193420/ 2020-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k193420-xo-cross-support-catheter-fda-510k.jpg K193420 - XO Cross Support Catheter K193420 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Transit Scientific. Cleared May 2020. https://www.510kdatabase.net/k193496/ 2020-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k193496-charmfil-fda-510k.jpg K193496 - CharmFil K193496 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentkist, Inc.. Cleared May 2020. https://www.510kdatabase.net/k201058/ 2020-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k201058-accuvue-fda-510k.jpg K201058 - Accuvue+ K201058 is a FDA 510(k) cleared radiology medical device. Manufacturer: Radmedix, LLC. Cleared May 2020. https://www.510kdatabase.net/k191590/ 2020-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k191590-aa-temp-temporary-restoration-3d-fda-510k.jpg K191590 - AA temp temporary restoration 3D printing photoreactive resin K191590 is a FDA 510(k) cleared dental medical device. Manufacturer: Enlighten Materials Co., Ltd.. Cleared May 2020. https://www.510kdatabase.net/k193176/ 2020-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k193176-umr-780-fda-510k.jpg K193176 - uMR 780 K193176 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared May 2020. https://www.510kdatabase.net/k193220/ 2020-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k193220-aview-lcs-fda-510k.jpg K193220 - AVIEW LCS K193220 is a FDA 510(k) cleared radiology medical device. Manufacturer: Coreline Soft Co., Ltd.. Cleared May 2020. https://www.510kdatabase.net/k200293/ 2020-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k200293-inmode-system-with-vtone-applicator-fda-510k.jpg K200293 - InMode System with vTone Applicator K200293 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Inmode , Ltd.. Cleared May 2020. https://www.510kdatabase.net/k200315/ 2020-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k200315-ziostation2-fda-510k.jpg K200315 - Ziostation2 K200315 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ziosoft, Inc.. Cleared May 2020. https://www.510kdatabase.net/k200546/ 2020-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k200546-zeeromed-view-fda-510k.jpg K200546 - ZeeroMED View K200546 is a FDA 510(k) cleared radiology medical device. Manufacturer: O3 Enterprise Srl. Cleared May 2020. https://www.510kdatabase.net/k200846/ 2020-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k200846-balteum-lumbar-plate-system-fda-510k.jpg K200846 - Balteum™ Lumbar Plate System K200846 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Huvexel Co. , Ltd.. Cleared May 2020. https://www.510kdatabase.net/k200914/ 2020-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k200914-healix-compression-screw-system-fda-510k.jpg K200914 - Healix Compression Screw System K200914 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nvision Biomedical Technologies, Inc.. Cleared May 2020. https://www.510kdatabase.net/k200933/ 2020-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k200933-syntec-non-sterile-steinmann-pins-system-fda-510k.jpg K200933 - Syntec Non-Sterile Steinmann Pins System K200933 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Syntec Scientific Corporation. Cleared May 2020. https://www.510kdatabase.net/k201184/ 2020-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k201184-lascod-impression-materials-fda-510k.jpg K201184 - Lascod Impression Materials K201184 is a FDA 510(k) cleared dental medical device. Manufacturer: Lascod Spa. Cleared May 2020. https://www.510kdatabase.net/k183110/ 2020-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k183110-livia-fda-510k.jpg K183110 - LIVIA K183110 is a FDA 510(k) cleared neurology medical device. Manufacturer: Lifecare , Ltd.. Cleared May 2020. https://www.510kdatabase.net/k192887/ 2020-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k192887-revitive-medic-plus-revitive-advanced-2-fda-510k.jpg K192887 - Revitive Medic Plus, Revitive Advanced 2 K192887 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Actegy , Ltd.. Cleared May 2020. https://www.510kdatabase.net/k193185/ 2020-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k193185-anscare-simo-negative-pressure-wound-fda-510k.jpg K193185 - Anscare SIMO Negative Pressure Wound Therapy (NPWT) System K193185 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Benq Materials Corporation. Cleared May 2020. https://www.510kdatabase.net/k193228/ 2020-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k193228-hamilton-g5-fda-510k.jpg K193228 - Hamilton-G5 K193228 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Hamilton Medical AG. Cleared May 2020. https://www.510kdatabase.net/k193516/ 2020-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k193516-sonata-sonography-guided-transcervical-fda-510k.jpg K193516 - Sonata® Sonography-Guided Transcervical Fibroid Ablation System 2.1 K193516 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Gynesonics, Inc.. Cleared May 2020. https://www.510kdatabase.net/k200035/ 2020-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k200035-ultravision-visual-field-clearing-system-fda-510k.jpg K200035 - Ultravision Visual Field Clearing System K200035 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Alesi Surgical, Ltd.. Cleared May 2020. https://www.510kdatabase.net/k200259/ 2020-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k200259-headless-compression-screw-system-fda-510k.jpg K200259 - Headless Compression Screw System K200259 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteocentric Extremities, LLC. Cleared May 2020. https://www.510kdatabase.net/k200871/ 2020-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k200871-aspire-max-7-11f-mechanical-fda-510k.jpg K200871 - Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical Aspirator K200871 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Control Medical Technology. Cleared May 2020. https://www.510kdatabase.net/k200417/ 2020-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k200417-rist-radial-access-catheter-fda-510k.jpg K200417 - RIST Radial Access Catheter K200417 is a FDA 510(k) cleared neurology medical device. Manufacturer: Rist Neurovascular, Inc.. Cleared May 2020. https://www.510kdatabase.net/k200910/ 2020-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k200910-boss-balloon-guide-catheter-fda-510k.jpg K200910 - BOSS Balloon Guide Catheter K200910 is a FDA 510(k) cleared neurology medical device. Manufacturer: Marblehead Medical. Cleared May 2020. https://www.510kdatabase.net/k192286/ 2020-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k192286-fujifilm-ep-6000-video-processor-fda-510k.jpg K192286 - FUJIFILM EP-6000 Video Processor K192286 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fujifilm Corporation. Cleared May 2020. https://www.510kdatabase.net/k192295/ 2020-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k192295-pdt-face-fda-510k.jpg K192295 - PDT-FACE K192295 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Beijing Adss Development Co., Ltd.. Cleared May 2020. https://www.510kdatabase.net/k192405/ 2020-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k192405-image-guidance-system-for-radiotherapy-fda-510k.jpg K192405 - Image Guidance System for Radiotherapy K192405 is a FDA 510(k) cleared radiology medical device. Manufacturer: Jiangsu Rayer Medical Technology Co., Ltd.. Cleared May 2020. https://www.510kdatabase.net/k192540/ 2020-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k192540-kitazato-et-catheters-fda-510k.jpg K192540 - Kitazato ET Catheters K192540 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Kitazato Corporation. Cleared May 2020. https://www.510kdatabase.net/k192633/ 2020-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k192633-gus831-compressor-nebulizer-fda-510k.jpg K192633 - GUS831 Compressor Nebulizer K192633 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Globalcare Medical Technology Co., Ltd.. Cleared May 2020. https://www.510kdatabase.net/k192656/ 2020-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k192656-optimized-positioning-system-ops-insight-fda-510k.jpg K192656 - Optimized Positioning System (OPS) Insight K192656 is a FDA 510(k) cleared radiology medical device. Manufacturer: Corin USA. Cleared May 2020. https://www.510kdatabase.net/k200173/ 2020-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k200173-stone-retrieval-balloon-fda-510k.jpg K200173 - Stone Retrieval Balloon K200173 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hangzhou AGS MedTech Co., Ltd.. Cleared May 2020. https://www.510kdatabase.net/k200279/ 2020-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k200279-immunocap-allergen-o215-component-ngal-fda-510k.jpg K200279 - ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovine K200279 is a FDA 510(k) cleared immunology medical device. Manufacturer: Phadia AB. Cleared May 2020. https://www.510kdatabase.net/k200453/ 2020-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k200453-non-sterile-powder-free-nitrile-fda-510k.jpg K200453 - NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, AND TESTED FOR USE WITH CHEMOTHERAPY DRUGS BLUE-AC K200453 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Yty Industry (Manjung) Sdn Bhd. Cleared May 2020. https://www.510kdatabase.net/k200571/ 2020-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k200571-perla-posterior-occipito-cervico-fda-510k.jpg K200571 - PERLA® Posterior Occipito-Cervico-Thoracic Fixation System K200571 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spineart. Cleared May 2020. https://www.510kdatabase.net/k200606/ 2020-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k200606-o-genesis-graft-delivery-system-fda-510k.jpg K200606 - O-Genesis Graft Delivery System K200606 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Orthofix, Inc.. Cleared May 2020. https://www.510kdatabase.net/k200870/ 2020-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k200870-carnation-ambulatory-monitor-fda-510k.jpg K200870 - Carnation Ambulatory Monitor K200870 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bardy Diagnostics, Inc.. Cleared May 2020. https://www.510kdatabase.net/k200917/ 2020-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k200917-azurion-r21-fda-510k.jpg K200917 - Azurion R2.1 K200917 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared May 2020. https://www.510kdatabase.net/k201004/ 2020-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k201004-wireless-digital-flat-panel-detector-fda-510k.jpg K201004 - Wireless Digital Flat Panel Detector Model Name Mars1417V-TSI, Wireless Digital Flat Panel Detector Model Name Mano4336W K201004 is a FDA 510(k) cleared radiology medical device. Manufacturer: Iray Technology Taicang , Ltd.. Cleared May 2020. https://www.510kdatabase.net/k201012/ 2020-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k201012-epiq-diagnostic-ultrasound-system-fda-510k.jpg K201012 - EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System K201012 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Ultrasound, Inc.. Cleared May 2020. https://www.510kdatabase.net/den180065/ 2020-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/den180065-ogmend-implant-system-fda-510k.jpg DEN180065 - OGmend Implant System DEN180065 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Woven Orthopedic Technologies, LLC. Cleared May 2020. https://www.510kdatabase.net/den190026/ 2020-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/den190026-itear-neurostimulator-fda-510k.jpg DEN190026 - iTEAR Neurostimulator DEN190026 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Olympic Ophthalmics, Inc.. Cleared May 2020. https://www.510kdatabase.net/k192169/ 2020-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k192169-pulsioflex-monitoring-system-with-fda-510k.jpg K192169 - PulsioFlex Monitoring System with ProAQT Sensor K192169 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Pulsion Medical Systems SE. Cleared Apr 2020. https://www.510kdatabase.net/k192246/ 2020-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k192246-biowy-picc-catheter-s-kit-fda-510k.jpg K192246 - Biowy PICC Catheter S Kit K192246 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Biowy Corporation. Cleared Apr 2020. https://www.510kdatabase.net/k192290/ 2020-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k192290-50g-sms-standard-surgical-gown-45g-sms-fda-510k.jpg K192290 - 50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g BVB Surgical Gown, 68g BVB Splicing Surgical Gown K192290 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Xuchang Zhengde Environstar Medical Products Co., Ltd.. Cleared Apr 2020. https://www.510kdatabase.net/k192350/ 2020-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k192350-medical-non-ablative-fractional-laser-fda-510k.jpg K192350 - Medical Non-Ablative Fractional Laser Systems K192350 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wingderm Electro-Optics , Ltd.. Cleared Apr 2020. https://www.510kdatabase.net/k193523/ 2020-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k193523-arthrexvip-web-portal-fda-510k.jpg K193523 - ArthrexVIP Web Portal K193523 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k200240/ 2020-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k200240-turbett-instrument-pod-fda-510k.jpg K200240 - Turbett Instrument Pod K200240 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Turbett Surgical, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k200519/ 2020-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k200519-carboclear-ii-pedicle-screw-system-fda-510k.jpg K200519 - CarboClear® II Pedicle Screw System K200519 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: CarboFix Orthopedics , Ltd.. Cleared Apr 2020. https://www.510kdatabase.net/k200523/ 2020-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k200523-biolign-roto-loc-cervical-plate-system-fda-510k.jpg K200523 - Biolign® Roto-Loc Cervical Plate System K200523 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Elite Surgical Supplies (Pty), Ltd.. Cleared Apr 2020. https://www.510kdatabase.net/k200816/ 2020-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k200816-spineex-sagittae-lateral-lumbar-fda-510k.jpg K200816 - SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices K200816 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spineex, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k200902/ 2020-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k200902-clickclean-fda-510k.jpg K200902 - ClickClean K200902 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medeon Biodesign, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k191816/ 2020-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k191816-m-vizion-femoral-revision-system-fda-510k.jpg K191816 - M-Vizion Femoral Revision System Extension K191816 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Apr 2020. https://www.510kdatabase.net/k191866/ 2020-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k191866-gelpoint-mini-advanced-access-platform-fda-510k.jpg K191866 - GelPOINT Mini Advanced Access Platform K191866 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Applied Medical. Cleared Apr 2020. https://www.510kdatabase.net/k191992/ 2020-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k191992-pelnac-bilayer-wound-matrix-fda-510k.jpg K191992 - PELNAC Bilayer Wound Matrix K191992 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Gunze Limited. Cleared Apr 2020. https://www.510kdatabase.net/k192097/ 2020-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k192097-exactech-equinoxe-stemless-humeral-fda-510k.jpg K192097 - Exactech® Equinoxe® Stemless Humeral Components K192097 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k192803/ 2020-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k192803-da-vinci-xi-surgical-system-da-vinci-x-fda-510k.jpg K192803 - da Vinci Xi Surgical System, da Vinci X Surgical System K192803 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical. Cleared Apr 2020. https://www.510kdatabase.net/k193394/ 2020-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k193394-humeral-cup-stability-humeral-cup-fda-510k.jpg K193394 - Humeral Cup Stability & Humeral Cup 135/145o Stability K193394 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Fx Shoulder USA, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k200327/ 2020-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k200327-evry-fda-510k.jpg K200327 - Evry K200327 is a FDA 510(k) cleared radiology medical device. Manufacturer: Synaptive Medical, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k200807/ 2020-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k200807-irraflow-catheter-irraflow-tube-set-fda-510k.jpg K200807 - IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit K200807 is a FDA 510(k) cleared neurology medical device. Manufacturer: Irras USA, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/den180055/ 2020-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/den180055-carpediem-system-fda-510k.jpg DEN180055 - CARPEDIEM System DEN180055 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Bellco Srl (Now Part of Medtronic, Inc). Cleared Apr 2020. https://www.510kdatabase.net/k192197/ 2020-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k192197-magicore-ii-system-fda-510k.jpg K192197 - Magicore II System K192197 is a FDA 510(k) cleared dental medical device. Manufacturer: Innobiosurg Co., Ltd.. Cleared Apr 2020. https://www.510kdatabase.net/k192498/ 2020-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k192498-single-use-injector-fda-510k.jpg K192498 - Single Use Injector K192498 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Apr 2020. https://www.510kdatabase.net/k193213/ 2020-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k193213-vicks-vnt200-no-touch-forehead-fda-510k.jpg K193213 - Vicks VNT200 No Touch Forehead Thermometer K193213 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Kaz USA, Inc., A Helen of Troy Company. Cleared Apr 2020. https://www.510kdatabase.net/k193592/ 2020-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k193592-neodent-implant-system-change-in-the-fda-510k.jpg K193592 - Neodent Implant System - Change in the Shelf Life of Neodent Acqua Implants K193592 is a FDA 510(k) cleared dental medical device. Manufacturer: Jjgc Industria E Comercio DE Materiais Dentarios S.A.. Cleared Apr 2020. https://www.510kdatabase.net/k200541/ 2020-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k200541-hive-stand-alone-anterior-lumbar-fda-510k.jpg K200541 - Hive™ Stand-alone Anterior Lumbar Interbody System K200541 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Hd Lifesciences, LLC. Cleared Apr 2020. https://www.510kdatabase.net/k200590/ 2020-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k200590-vitek-2-ast-gram-positive-delafloxacin-fda-510k.jpg K200590 - VITEK 2 AST-Gram Positive Delafloxacin (<=0.015 - >=1 µg/mL) K200590 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k200814/ 2020-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k200814-affixusr-natural-nailr-system-humeral-fda-510k.jpg K200814 - Affixus(R) Natural Nail(R) System Humeral Nail K200814 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer GmbH. Cleared Apr 2020. https://www.510kdatabase.net/k200863/ 2020-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k200863-tiger-occipital-cervical-thoracic-fda-510k.jpg K200863 - Tiger® Occipital-Cervical-Thoracic Spinal Fixation System K200863 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corelink, LLC. Cleared Apr 2020. https://www.510kdatabase.net/k200867/ 2020-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k200867-implantswiss-dental-implant-system-and-fda-510k.jpg K200867 - Implantswiss Dental Implant System and Implantswiss Dental Abutment System K200867 is a FDA 510(k) cleared dental medical device. Manufacturer: Novodent SA. Cleared Apr 2020. https://www.510kdatabase.net/k200896/ 2020-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k200896-solstice-cci-fda-510k.jpg K200896 - Solstice CCI K200896 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k193350/ 2020-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k193350-leadtek-fingertip-pulse-oximeter-fda-510k.jpg K193350 - Leadtek Fingertip Pulse Oximeter K193350 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Leadtek Research, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k193388/ 2020-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k193388-glasslok-kits-glasslok-powder-glasslok-fda-510k.jpg K193388 - GlassLok Kits, GlassLok Powder, GlassLok Liquid K193388 is a FDA 510(k) cleared dental medical device. Manufacturer: Reliance Orthodontic Products, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k193459/ 2020-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k193459-panther-stereotactic-fda-510k.jpg K193459 - Panther Stereotactic K193459 is a FDA 510(k) cleared radiology medical device. Manufacturer: Prowess, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k200101/ 2020-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k200101-wolf-thrombectomy-v-system-fda-510k.jpg K200101 - WOLF Thrombectomy V System K200101 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Devoro Medical, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k200141/ 2020-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k200141-oxi-w-system-fda-510k.jpg K200141 - Oxi-W System K200141 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Ld Technology, LLC. Cleared Apr 2020. https://www.510kdatabase.net/k200208/ 2020-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k200208-agape-warming-personal-lubricant-fda-510k.jpg K200208 - Agape Warming Personal Lubricant K200208 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: CC Wellness, LLC. Cleared Apr 2020. https://www.510kdatabase.net/k200254/ 2020-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k200254-mydriatic-hyperspectral-retinal-camera-fda-510k.jpg K200254 - Mydriatic Hyperspectral Retinal Camera (MHRC-C1) K200254 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Optina Diagnostics. Cleared Apr 2020. https://www.510kdatabase.net/k200533/ 2020-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k200533-binx-io-ctng-assay-and-binx-io-ctng-fda-510k.jpg K200533 - binx io CT/NG Assay and binx io CT/NG System K200533 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Binx Health, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k200594/ 2020-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k200594-capnostream-35-portable-respiratory-fda-510k.jpg K200594 - Capnostream 35 Portable Respiratory Monitor K200594 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Oridion Medical 1987 , Ltd.. Cleared Apr 2020. https://www.510kdatabase.net/k200624/ 2020-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k200624-percutaneous-introducer-fda-510k.jpg K200624 - Percutaneous Introducer K200624 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Epimed International, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k192834/ 2020-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k192834-mecta-sigma-fda-510k.jpg K192834 - MECTA Sigma K192834 is a FDA 510(k) cleared neurology medical device. Manufacturer: Mecta Corporation. Cleared Apr 2020. https://www.510kdatabase.net/k200238/ 2020-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k200238-controlrad-sterile-cover-fda-510k.jpg K200238 - ControlRad Sterile Cover K200238 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Controlrad, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k192068/ 2020-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k192068-i-ed-coil-fda-510k.jpg K192068 - i-ED COIL K192068 is a FDA 510(k) cleared neurology medical device. Manufacturer: Kaneka Pharma America, LLC. Cleared Apr 2020. https://www.510kdatabase.net/k192786/ 2020-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k192786-gatekeeper-balloon-catheter-fda-510k.jpg K192786 - Gatekeeper Balloon Catheter K192786 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Arch Catheter, LLC. Cleared Apr 2020. https://www.510kdatabase.net/k200007/ 2020-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k200007-profemur-gladiator-thin-ha-classic-hip-fda-510k.jpg K200007 - PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar K200007 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Microport Orthopedics, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k200581/ 2020-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k200581-biodegradable-nitrile-powder-free-fda-510k.jpg K200581 - Biodegradable Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue) K200581 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hartalega NGC Sdn. Bhd.. Cleared Apr 2020. https://www.510kdatabase.net/k190139/ 2020-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k190139-zircos-com-fda-510k.jpg K190139 - Zircos-Com K190139 is a FDA 510(k) cleared dental medical device. Manufacturer: Bioden Co., Ltd.. Cleared Apr 2020. https://www.510kdatabase.net/k191492/ 2020-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k191492-maxxi-position-sensor-fda-510k.jpg K191492 - Maxxi Position Sensor K191492 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neurovirtual USA, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k192017/ 2020-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k192017-citrasate-liquid-acid-concentrate-fda-510k.jpg K192017 - Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate K192017 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC. Cleared Apr 2020. https://www.510kdatabase.net/k192063/ 2020-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k192063-pgdx-elio-tissue-complete-fda-510k.jpg K192063 - PGDx elio tissue complete K192063 is a FDA 510(k) cleared pathology medical device. Manufacturer: Personal Genome Diagnostics. Cleared Apr 2020. https://www.510kdatabase.net/k192408/ 2020-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k192408-custodiol-htk-solution-fda-510k.jpg K192408 - Custodiol HTK Solution K192408 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Dr. Franz Kohler Chemie GmbH. Cleared Apr 2020. https://www.510kdatabase.net/k192856/ 2020-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k192856-mt-one-fda-510k.jpg K192856 - MT One K192856 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: M&T S.R.L.. Cleared Apr 2020. https://www.510kdatabase.net/k193033/ 2020-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k193033-gsi-audera-pro-fda-510k.jpg K193033 - GSI Audera Pro K193033 is a FDA 510(k) cleared neurology medical device. Manufacturer: Grason Stadler. Cleared Apr 2020. https://www.510kdatabase.net/k193153/ 2020-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k193153-spira-c-integrated-fixation-system-fda-510k.jpg K193153 - SPIRA-C Integrated Fixation System K193153 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Camber Spine Technologies. Cleared Apr 2020. https://www.510kdatabase.net/k193636/ 2020-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k193636-seaspine-reef-th-system-fda-510k.jpg K193636 - SeaSpine Reef TH System K193636 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared Apr 2020. https://www.510kdatabase.net/k200074/ 2020-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k200074-o-arm-o2-imaging-system-fda-510k.jpg K200074 - O-arm O2 Imaging System K200074 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medtronic, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k200245/ 2020-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k200245-expedium-spine-system-fda-510k.jpg K200245 - EXPEDIUM® Spine System K200245 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International S?rl. Cleared Apr 2020. https://www.510kdatabase.net/k200397/ 2020-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k200397-single-use-biopsy-forceps-fb-456d-fda-510k.jpg K200397 - Single Use Biopsy Forceps FB-456D K200397 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Apr 2020. https://www.510kdatabase.net/k200826/ 2020-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k200826-smithnephew-visionaire-patient-matched-fda-510k.jpg K200826 - Smith&Nephew VISIONAIRE Patient Matched Cutting Blocks K200826 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k191308/ 2020-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k191308-u-aligner-fda-510k.jpg K191308 - U-Aligner K191308 is a FDA 510(k) cleared dental medical device. Manufacturer: Universal Orthodontic Laboratory, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k192183/ 2020-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k192183-rocatub-ureteral-catheter-fda-510k.jpg K192183 - RocaTub Ureteral Catheter K192183 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Promepal Sam. Cleared Apr 2020. https://www.510kdatabase.net/k192230/ 2020-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k192230-mf-safecath-fda-510k.jpg K192230 - MF SAFECATH K192230 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medifirst Co., Ltd.. Cleared Apr 2020. https://www.510kdatabase.net/k192358/ 2020-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k192358-pressure-therapy-system-pt1003-fda-510k.jpg K192358 - Pressure Therapy System PT1003 K192358 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Xiamen Senyang Co., Ltd.. Cleared Apr 2020. https://www.510kdatabase.net/k192475/ 2020-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k192475-nemofab-fda-510k.jpg K192475 - NemoFAB K192475 is a FDA 510(k) cleared dental medical device. Manufacturer: Software Nemotec S.L.. Cleared Apr 2020. https://www.510kdatabase.net/k192644/ 2020-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k192644-gm501-spermair-and-gm501-spermactive-fda-510k.jpg K192644 - GM501 SpermAir and GM501 SpermActive K192644 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Hamilton Thorne Incorporated. Cleared Apr 2020. https://www.510kdatabase.net/k192807/ 2020-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k192807-duo-flow-side-x-side-double-lumen-fda-510k.jpg K192807 - Duo-Flow Side x Side Double Lumen Catheter K192807 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medical Components, Inc. (dba MedComp). Cleared Apr 2020. https://www.510kdatabase.net/k193305/ 2020-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k193305-dynaclip-bone-staple-fda-510k.jpg K193305 - DynaClip Bone Staple K193305 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: MedShape, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k200070/ 2020-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k200070-arx-spinal-system-fda-510k.jpg K200070 - ARx Spinal System K200070 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k200167/ 2020-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k200167-quikclot-control-fda-510k.jpg K200167 - QuikClot Control+ K200167 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Z-Medica, LLC. Cleared Apr 2020. https://www.510kdatabase.net/k200444/ 2020-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k200444-biomonitor-iii-biomonitor-iiim-fda-510k.jpg K200444 - Biomonitor III, Biomonitor IIIm K200444 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biotronik, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k200666/ 2020-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k200666-stryker-xia-3-power-adaptor-fda-510k.jpg K200666 - Stryker Xia 3 Power Adaptor K200666 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Spine. Cleared Apr 2020. https://www.510kdatabase.net/k200705/ 2020-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k200705-nurochek-system-fda-510k.jpg K200705 - Nurochek System K200705 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cryptych Pty, Ltd.. Cleared Apr 2020. https://www.510kdatabase.net/k200762/ 2020-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k200762-colink-cfx-plating-system-fda-510k.jpg K200762 - CoLink Cfx Plating System K200762 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: In2bones USA, LLC. Cleared Apr 2020. https://www.510kdatabase.net/k200787/ 2020-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k200787-bsd3543w-fda-510k.jpg K200787 - BSD3543W K200787 is a FDA 510(k) cleared radiology medical device. Manufacturer: Bontech Co., Ltd.. Cleared Apr 2020. https://www.510kdatabase.net/k200847/ 2020-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k200847-surgical-face-mask-fda-510k.jpg K200847 - Surgical Face Mask K200847 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Mexpo International, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k190984/ 2020-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k190984-infrared-forehead-thermometer-fda-510k.jpg K190984 - Infrared Forehead Thermometer K190984 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Xiamen Ants Bro Technology Co., Ltd.. Cleared Apr 2020. https://www.510kdatabase.net/k191882/ 2020-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k191882-masimo-centroid-system-fda-510k.jpg K191882 - Masimo Centroid System K191882 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Masimo Corporation. Cleared Apr 2020. https://www.510kdatabase.net/k191997/ 2020-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k191997-faico-cmf-system-fda-510k.jpg K191997 - FAICO CMF System K191997 is a FDA 510(k) cleared dental medical device. Manufacturer: Faico Medical, LLC. Cleared Apr 2020. https://www.510kdatabase.net/k192517/ 2020-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k192517-psychemedics-microplate-eia-for-fda-510k.jpg K192517 - Psychemedics Microplate EIA for Cotinine in Hair K192517 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Psychemedics Corporation. Cleared Apr 2020. https://www.510kdatabase.net/k200168/ 2020-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k200168-dermapose-access-fda-510k.jpg K200168 - Dermapose Access K200168 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Puregraft, LLC. Cleared Apr 2020. https://www.510kdatabase.net/k200185/ 2020-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k200185-sylfirm-x-fda-510k.jpg K200185 - SYLFIRM X K200185 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: VIOL Co., Ltd.. Cleared Apr 2020. https://www.510kdatabase.net/k200585/ 2020-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k200585-acuson-sc2000-diagnostic-ultrasound-fda-510k.jpg K200585 - Acuson SC2000 Diagnostic Ultrasound System K200585 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k200752/ 2020-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k200752-db-orthopedics-fda-510k.jpg K200752 - DB-Orthopedics K200752 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Dimensional Bioceramics, LLC. Cleared Apr 2020. https://www.510kdatabase.net/k200771/ 2020-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k200771-indigo-aspiration-system-lightning-fda-510k.jpg K200771 - Indigo Aspiration System Lightning Aspiration Tubing K200771 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Penumbra, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k192034/ 2020-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k192034-hdx-100-silicone-2-way-foley-catheter-fda-510k.jpg K192034 - HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc K192034 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Pathway, LLC. Cleared Apr 2020. https://www.510kdatabase.net/k192082/ 2020-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k192082-droplet-pen-needle-34g-fda-510k.jpg K192082 - Droplet Pen Needle 34G K192082 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Htl-Strefa S.A. Cleared Apr 2020. https://www.510kdatabase.net/k192145/ 2020-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k192145-galileo-vertebral-body-replacement-fda-510k.jpg K192145 - Galileo Vertebral Body Replacement Device K192145 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Bright Spine. Cleared Apr 2020. https://www.510kdatabase.net/k192492/ 2020-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k192492-el-capitan-anterior-lumber-interbody-fda-510k.jpg K192492 - EL CAPITAN Anterior Lumber Interbody System K192492 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Astura Medical, LLC. Cleared Apr 2020. https://www.510kdatabase.net/k192609/ 2020-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k192609-globalcare-blood-pressure-monitor-fda-510k.jpg K192609 - Globalcare Blood Pressure Monitor K192609 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Globalcare Medical Technology Co., Ltd.. Cleared Apr 2020. https://www.510kdatabase.net/k192701/ 2020-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k192701-dibs-digital-indirect-bonding-system-fda-510k.jpg K192701 - DIBS (Digital Indirect Bonding System) K192701 is a FDA 510(k) cleared dental medical device. Manufacturer: Orthoselect, LLC. Cleared Apr 2020. https://www.510kdatabase.net/k193074/ 2020-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k193074-bevel-up-holder-fda-510k.jpg K193074 - Bevel Up Holder K193074 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Nsp Tech Pte, Ltd.. Cleared Apr 2020. https://www.510kdatabase.net/k193161/ 2020-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k193161-pristine-scope-fda-510k.jpg K193161 - Pristine Scope K193161 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Pristine Surgical. Cleared Apr 2020. https://www.510kdatabase.net/k193351/ 2020-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k193351-ninesai-fda-510k.jpg K193351 - NinesAI K193351 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nines, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k200053/ 2020-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k200053-dannik-specimen-retrieval-system-with-fda-510k.jpg K200053 - DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only) K200053 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Dannik. Cleared Apr 2020. https://www.510kdatabase.net/k200162/ 2020-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k200162-disposable-eeg-electrodes-model-dl-e-fda-510k.jpg K200162 - Disposable EEG Electrodes (MODEL: DL, E-CAP, FLEX-CAP) K200162 is a FDA 510(k) cleared neurology medical device. Manufacturer: Wuhan Greentek Pty , Ltd.. Cleared Apr 2020. https://www.510kdatabase.net/k200744/ 2020-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k200744-instylla-microcatheter-fda-510k.jpg K200744 - Instylla Microcatheter K200744 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Instylla, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k200745/ 2020-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k200745-lariat-hotcold-snare-fda-510k.jpg K200745 - Lariat, Hot/Cold Snare K200745 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: United States Endoscopy Group, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k192154/ 2020-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k192154-rio-vial-to-bag-drug-reconstitution-fda-510k.jpg K192154 - Rio Vial-to-Bag Drug Reconstitution Device K192154 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Icu Medical. Cleared Apr 2020. https://www.510kdatabase.net/k192382/ 2020-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k192382-capklenz-fda-510k.jpg K192382 - CapKlenZ K192382 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Star Mountain Medical, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k193032/ 2020-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k193032-ky-grosz-liquid-fda-510k.jpg K193032 - KY Grosz Liquid K193032 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Rb Health (Us), LLC. Cleared Apr 2020. https://www.510kdatabase.net/k193197/ 2020-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k193197-quickclear-mechanical-thrombectomy-fda-510k.jpg K193197 - QuickClear Mechanical Thrombectomy System K193197 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Volcano Atheromed, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k193343/ 2020-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k193343-vista-solution-monitoring-kit-vista-fda-510k.jpg K193343 - Vista Solution Monitoring Kit, Vista Solution 2 10-day Evaluation Kit, VistaTablet 2 (Boxed) K193343 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vitalconnect, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k200024/ 2020-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k200024-umr-570-fda-510k.jpg K200024 - uMR 570 K200024 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Apr 2020. https://www.510kdatabase.net/k200122/ 2020-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k200122-moto-pfj-system-fda-510k.jpg K200122 - MOTO PFJ System K200122 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Apr 2020. https://www.510kdatabase.net/k200559/ 2020-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k200559-carpx-fda-510k.jpg K200559 - CarpX K200559 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Pavmed, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k200600/ 2020-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k200600-sentinel-fda-510k.jpg K200600 - Sentinel K200600 is a FDA 510(k) cleared radiology medical device. Manufacturer: C-Rad Positioning AB. Cleared Apr 2020. https://www.510kdatabase.net/k191995/ 2020-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k191995-s4-screw-system-fda-510k.jpg K191995 - S4 Screw System K191995 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Subchondral Solutions, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k200121/ 2020-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k200121-route-92-medical-088-access-system-110-fda-510k.jpg K200121 - Route 92 Medical 088 Access System, 110 cm K200121 is a FDA 510(k) cleared neurology medical device. Manufacturer: Route 92 Medical, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k191720/ 2020-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k191720-bruis-software-suite-fda-510k.jpg K191720 - BRUIS Software Suite K191720 is a FDA 510(k) cleared dental medical device. Manufacturer: Mechanodontics, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k192552/ 2020-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k192552-irradiation-cosmetic-device-fda-510k.jpg K192552 - Irradiation Cosmetic Device K192552 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Chongqing Peninsula Medical Technology Co., Ltd.. Cleared Apr 2020. https://www.510kdatabase.net/k200118/ 2020-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k200118-diode-laser-therapy-device-fda-510k.jpg K200118 - Diode Laser Therapy Device K200118 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shanghai Apolo Medical Technology Co., Ltd.. Cleared Apr 2020. https://www.510kdatabase.net/k200158/ 2020-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k200158-logiq-e10-fda-510k.jpg K200158 - LOGIQ E10 K200158 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. Cleared Apr 2020. https://www.510kdatabase.net/k200257/ 2020-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k200257-wallflex-colonic-soft-stent-system-fda-510k.jpg K200257 - WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System K200257 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Apr 2020. https://www.510kdatabase.net/k200338/ 2020-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k200338-prolift-lateral-fixated-fda-510k.jpg K200338 - ProLift Lateral Fixated K200338 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k200709/ 2020-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k200709-kyocera-bipolar-hip-system-fda-510k.jpg K200709 - Kyocera Bipolar Hip System K200709 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Kyocera Medical Technologies, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k200712/ 2020-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k200712-rumble-tuff-electric-breast-pump-fda-510k.jpg K200712 - Rumble Tuff Electric Breast Pump K200712 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: A Cute Baby, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k200733/ 2020-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k200733-opticross-35-15-mhz-peripheral-imaging-fda-510k.jpg K200733 - Opticross 35 15 MHz Peripheral Imaging Catheter K200733 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Apr 2020. https://www.510kdatabase.net/k200868/ 2020-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k200868-si-restore-sacroiliac-joint-fixation-fda-510k.jpg K200868 - SI-Restore Sacroiliac Joint Fixation System K200868 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biofusion Medical. Cleared Apr 2020. https://www.510kdatabase.net/k192875/ 2020-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k192875-philips-biosensor-bx100-fda-510k.jpg K192875 - Philips Biosensor BX100 K192875 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Philips Medical Systems. Cleared Apr 2020. https://www.510kdatabase.net/k193124/ 2020-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k193124-unicel-dxh-800-coulter-cellular-fda-510k.jpg K193124 - Unicel DxH 800 Coulter Cellular Analysis System K193124 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Coulter. Cleared Apr 2020. https://www.510kdatabase.net/k193326/ 2020-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k193326-artis-icono-fda-510k.jpg K193326 - ARTIS Icono K193326 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k193549/ 2020-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k193549-sigma-high-performance-hp-partial-knee-fda-510k.jpg K193549 - SIGMA High Performance (HP) Partial Knee System K193549 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Ireland UC. Cleared Apr 2020. https://www.510kdatabase.net/k193588/ 2020-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k193588-dd-contrast-fda-510k.jpg K193588 - DD Contrast K193588 is a FDA 510(k) cleared dental medical device. Manufacturer: Dental Direkt GmbH. Cleared Apr 2020. https://www.510kdatabase.net/k200547/ 2020-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k200547-traxcess-14-select-guidewire-fda-510k.jpg K200547 - Traxcess 14 SELECT Guidewire K200547 is a FDA 510(k) cleared neurology medical device. Manufacturer: MicroVention, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k200670/ 2020-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k200670-eon-portable-ro-water-purification-fda-510k.jpg K200670 - EON Portable RO Water Purification System K200670 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Mar Cor Purification, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k200729/ 2020-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k200729-hydrocision-spinejet-system-fda-510k.jpg K200729 - HydroCision SpineJet System K200729 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Hydrocision, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k200755/ 2020-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k200755-caption-guidance-fda-510k.jpg K200755 - Caption Guidance K200755 is a FDA 510(k) cleared radiology medical device. Manufacturer: Caption Health. Cleared Apr 2020. https://www.510kdatabase.net/den190028/ 2020-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/den190028-mycare-psychiatry-clozapine-assay-kit-fda-510k.jpg DEN190028 - MyCare Psychiatry Clozapine Assay Kit DEN190028 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Saladax Biomedical, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k191930/ 2020-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k191930-7-mm-extended-length-endoscope-fda-510k.jpg K191930 - 7 mm Extended Length Endoscope K191930 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Maquet Cardiovascular, LLC. Cleared Apr 2020. https://www.510kdatabase.net/k192588/ 2020-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k192588-g-eye-system-fda-510k.jpg K192588 - G-EYE System K192588 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Smart Medical Systems , Ltd.. Cleared Apr 2020. https://www.510kdatabase.net/k193181/ 2020-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k193181-serranator-pta-serration-balloon-fda-510k.jpg K193181 - Serranator PTA Serration Balloon Catheter K193181 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cagent Vascular, LLC. Cleared Apr 2020. https://www.510kdatabase.net/k193373/ 2020-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k193373-comprehensive-reverse-shoulder-fda-510k.jpg K193373 - Comprehensive® Reverse Shoulder K193373 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k193534/ 2020-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k193534-monarch-platform-fda-510k.jpg K193534 - Monarch Platform K193534 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Auris Health, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k193561/ 2020-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k193561-diposable-medical-device-self-seal-fda-510k.jpg K193561 - Diposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch K193561 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Weihai Xingtai Packaging Products Co., Ltd.. Cleared Apr 2020. https://www.510kdatabase.net/k200092/ 2020-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k200092-3mtm-attesttm-mini-auto-reader-490m-fda-510k.jpg K200092 - 3MTM AttestTM Mini Auto-reader 490M K200092 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M. Cleared Apr 2020. https://www.510kdatabase.net/k200181/ 2020-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k200181-black-colored-powder-free-nitrile-fda-510k.jpg K200181 - Black Colored Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate K200181 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Comfort Rubber Gloves Industries Sdn. Bhd.. Cleared Apr 2020. https://www.510kdatabase.net/k200500/ 2020-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k200500-molekule-air-pro-rx-fda-510k.jpg K200500 - Molekule Air Pro RX K200500 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Molekule, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k200613/ 2020-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k200613-tritanium-x-tl-expandable-curved-fda-510k.jpg K200613 - Tritanium® X TL Expandable Curved Posterior Lumbar Cage K200613 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Corporation. Cleared Apr 2020. https://www.510kdatabase.net/k200625/ 2020-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k200625-i-view-gold-and-imagen-gold-dental-fda-510k.jpg K200625 - I-View Gold and Imagen Gold Dental Sensors K200625 is a FDA 510(k) cleared radiology medical device. Manufacturer: Trident S.R.L. Cleared Apr 2020. https://www.510kdatabase.net/k200707/ 2020-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k200707-acuson-sequoia-diagnostic-ultrasound-fda-510k.jpg K200707 - ACUSON Sequoia Diagnostic Ultrasound System K200707 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k200887/ 2020-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k200887-as-10-fda-510k.jpg K200887 - AS-10 K200887 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k182400/ 2020-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k182400-solax-powered-wheelchair-models-s7101-fda-510k.jpg K182400 - Solax Powered Wheelchair (Models: S7101, S7103) K182400 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Dongguan Prestige Sporting Goods Co., Ltd.. Cleared Apr 2020. https://www.510kdatabase.net/k191353/ 2020-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k191353-comet-lumbar-interbody-fusion-cage-fda-510k.jpg K191353 - COMET Lumbar Interbody Fusion Cage K191353 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Baui Biotech Co., Ltd.. Cleared Apr 2020. https://www.510kdatabase.net/k191654/ 2020-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k191654-silicone-personal-lubricant-fda-510k.jpg K191654 - SILICONE Personal Lubricant K191654 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Bath Concept Cosmetics (Dongguan) Co., Ltd.. Cleared Apr 2020. https://www.510kdatabase.net/k191803/ 2020-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k191803-orthopedic-fixation-pin-fda-510k.jpg K191803 - Orthopedic Fixation Pin K191803 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tinavi (Anhui) Medical Technologies Co., Ltd.. Cleared Apr 2020. https://www.510kdatabase.net/k192781/ 2020-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k192781-urolift-system-procedure-kit-fda-510k.jpg K192781 - UroLift System Procedure Kit Sterilization Tray K192781 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Neotract, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k192982/ 2020-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k192982-ky-grosz-ultragel-fda-510k.jpg K192982 - KY Grosz UltraGel K192982 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Rb Health (Us), LLC. Cleared Apr 2020. https://www.510kdatabase.net/k193349/ 2020-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k193349-vapocoolshot-mist-fda-510k.jpg K193349 - Vapocoolshot Mist K193349 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Vapocoolshot, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k193363/ 2020-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k193363-dermapose-refresh-fda-510k.jpg K193363 - Dermapose Refresh K193363 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Puregraft, LLC. Cleared Apr 2020. https://www.510kdatabase.net/k193369/ 2020-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k193369-xelis-dental-20-fda-510k.jpg K193369 - Xelis Dental 2.0 K193369 is a FDA 510(k) cleared radiology medical device. Manufacturer: Infinitt Healthcare Co., Ltd.. Cleared Apr 2020. https://www.510kdatabase.net/k200388/ 2020-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k200388-vacutore-airwater-bottle-tubing-fda-510k.jpg K200388 - Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector K200388 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ga Health Company Limited. Cleared Apr 2020. https://www.510kdatabase.net/k200403/ 2020-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k200403-stat-profile-prime-plus-analyzer-system-fda-510k.jpg K200403 - Stat Profile Prime Plus Analyzer System K200403 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Nova Biomedical Corporation. Cleared Apr 2020. https://www.510kdatabase.net/k200703/ 2020-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k200703-jivex-fda-510k.jpg K200703 - JiveX K200703 is a FDA 510(k) cleared radiology medical device. Manufacturer: Visus Health IT GmbH. Cleared Apr 2020. https://www.510kdatabase.net/k192167/ 2020-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k192167-curarad-ich-fda-510k.jpg K192167 - CuraRad-ICH K192167 is a FDA 510(k) cleared radiology medical device. Manufacturer: Curacloud Corp.. Cleared Apr 2020. https://www.510kdatabase.net/k192838/ 2020-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k192838-quantumn-centrifugal-drive-high-fda-510k.jpg K192838 - Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium Pressure K192838 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Spectrum Medical , Ltd.. Cleared Apr 2020. https://www.510kdatabase.net/k192850/ 2020-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k192850-quantum-pureflow-centrifugal-blood-fda-510k.jpg K192850 - Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22 K192850 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Qura S.R.L. Cleared Apr 2020. https://www.510kdatabase.net/k193464/ 2020-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k193464-ndyag-laser-fda-510k.jpg K193464 - ND:YAG Laser K193464 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Beijing Superlaser Technology Co., Ltd.. Cleared Apr 2020. https://www.510kdatabase.net/k200099/ 2020-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k200099-s-clean-sq-sl-implant-system-mini-fda-510k.jpg K200099 - s-Clean SQ-SL Implant System Mini K200099 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentis Co., Ltd.. Cleared Apr 2020. https://www.510kdatabase.net/k200215/ 2020-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k200215-advia-centaur-cea-assay-fda-510k.jpg K200215 - ADVIA Centaur CEA Assay K200215 is a FDA 510(k) cleared immunology medical device. Manufacturer: Siemens Healthcare Disgnostics, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k200300/ 2020-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k200300-vivaer-stylus-fda-510k.jpg K200300 - VivAer Stylus K200300 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Aerin Medical, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k200726/ 2020-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k200726-acuitypdr-fda-510k.jpg K200726 - AcuityPDR K200726 is a FDA 510(k) cleared radiology medical device. Manufacturer: Radmedix, LLC. Cleared Apr 2020. https://www.510kdatabase.net/k200665/ 2020-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k200665-verasense-for-stryker-triathlon-fda-510k.jpg K200665 - VERASENSE for Stryker Triathlon K200665 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthosensor, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k193275/ 2020-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k193275-nerve-and-muscle-stimulator-fda-510k.jpg K193275 - Nerve and Muscle Stimulator K193275 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Shenzhen Xft Medical Limited. Cleared Apr 2020. https://www.510kdatabase.net/k190353/ 2020-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k190353-bfit-sleep-bfit-sleep-with-dentitrac-fda-510k.jpg K190353 - Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac K190353 is a FDA 510(k) cleared dental medical device. Manufacturer: Residential Home Sleep Services. Cleared Apr 2020. https://www.510kdatabase.net/k192679/ 2020-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k192679-sterile-syringe-with-safety-needle-for-fda-510k.jpg K192679 - Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use K192679 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Gemtier Medical (Shanghai), Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k193215/ 2020-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k193215-achieva-intera-ingenia-ingneia-cx-fda-510k.jpg K193215 - Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems K193215 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Apr 2020. https://www.510kdatabase.net/k193282/ 2020-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k193282-signa-premier-fda-510k.jpg K193282 - SIGNA Premier K193282 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare (Ge Medical Systems, LLC). Cleared Apr 2020. https://www.510kdatabase.net/k193573/ 2020-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k193573-biogel-skinsense-indicator-underglove-fda-510k.jpg K193573 - Biogel Skinsense Indicator Underglove, Biogel PI Ultratouch, Biogel PI Indicator Underglove, Biogel PI, Biogel PI Micro K193573 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Molnlycke Health Care Us, LLC. Cleared Apr 2020. https://www.510kdatabase.net/k200044/ 2020-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k200044-skinstylus-sterilock-microsystem-fda-510k.jpg K200044 - SkinStylus SteriLock MicroSystem K200044 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Esthetic Education, LLC. Cleared Apr 2020. https://www.510kdatabase.net/k200072/ 2020-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k200072-kimtech-purple-nitrile-powder-free-fda-510k.jpg K200072 - KIMTECH Purple Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs, the Opioid Fentanyl, Gastric acid, and Fentanyl in Gastric acid K200072 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Kimberly Clark Corporation. Cleared Apr 2020. https://www.510kdatabase.net/k200078/ 2020-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k200078-varo-plan-fda-510k.jpg K200078 - VARO Plan K200078 is a FDA 510(k) cleared radiology medical device. Manufacturer: 3D Industrial Imaging Co., Ltd.. Cleared Apr 2020. https://www.510kdatabase.net/k200112/ 2020-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k200112-zimmer-hip-joint-replacement-fda-510k.jpg K200112 - Zimmer Hip Joint Replacement K200112 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer GmbH. Cleared Apr 2020. https://www.510kdatabase.net/k200642/ 2020-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k200642-orthalign-plus-system-fda-510k.jpg K200642 - OrthAlign Plus System K200642 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthalign, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k200644/ 2020-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k200644-acuson-freestyle-diagnostic-ultrasound-fda-510k.jpg K200644 - ACUSON Freestyle Diagnostic Ultrasound System K200644 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k200668/ 2020-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k200668-dr-id-1200sdk-system-fda-510k.jpg K200668 - DR-ID 1200SDK System K200668 is a FDA 510(k) cleared radiology medical device. Manufacturer: Fujifilm Corporation. Cleared Apr 2020. https://www.510kdatabase.net/k191574/ 2020-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k191574-oxsat-100-fda-510k.jpg K191574 - OxSAT 100 K191574 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: S.L.P. , Ltd.. Cleared Apr 2020. https://www.510kdatabase.net/k191867/ 2020-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k191867-atlas-plating-system-fda-510k.jpg K191867 - ATLAS Plating System K191867 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: MiRus, LLC. Cleared Apr 2020. https://www.510kdatabase.net/k191935/ 2020-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k191935-nautilus-smart-ecmo-module-fda-510k.jpg K191935 - Nautilus Smart ECMO Module K191935 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Mc3 Incorporated. Cleared Apr 2020. https://www.510kdatabase.net/k192138/ 2020-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k192138-rejuvapen-nxt-fda-510k.jpg K192138 - Rejuvapen NXT K192138 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Refine USA, LLC. Cleared Apr 2020. https://www.510kdatabase.net/k193104/ 2020-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k193104-unified-arrhythmia-diagnostic-system-fda-510k.jpg K193104 - Unified Arrhythmia Diagnostic System PocketECG IV K193104 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medicalgorithmics S.A.. Cleared Apr 2020. https://www.510kdatabase.net/k193329/ 2020-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k193329-prexion3d-explorer-ex-fda-510k.jpg K193329 - PreXion3D Explorer EX K193329 is a FDA 510(k) cleared radiology medical device. Manufacturer: Prexion Corporation. Cleared Apr 2020. https://www.510kdatabase.net/k193640/ 2020-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k193640-clearcalc-fda-510k.jpg K193640 - ClearCalc K193640 is a FDA 510(k) cleared radiology medical device. Manufacturer: Radformation, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k200001/ 2020-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k200001-mx7-mx7t-vaus7-zeus-diagnostic-fda-510k.jpg K200001 - MX7/ MX7T/ Vaus7/ Zeus Diagnostic Ultrasound System, ME7/ Anesus ME7/ Anesus ME7T Diagnostic Ultrasound System, MX8/ MX8T/ Vaus8/ ME8 Diagnostic Ultrasound System K200001 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Apr 2020. https://www.510kdatabase.net/k200052/ 2020-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k200052-construx-mini-ptc-spacer-system-forza-fda-510k.jpg K200052 - CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer System K200052 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthofix, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k200326/ 2020-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k200326-powder-free-nitrile-examination-glove-fda-510k.jpg K200326 - Powder Free Nitrile Examination Glove (Aqua Green) K200326 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Riverstone Resources Sdn Bhd. Cleared Apr 2020. https://www.510kdatabase.net/k200492/ 2020-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k200492-i-stat-cg4-cartridge-with-the-i-stat-1-fda-510k.jpg K200492 - i-STAT CG4+ Cartridge with the i-STAT 1 System K200492 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Point of Care, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k200517/ 2020-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k200517-standard-trocar-fda-510k.jpg K200517 - Standard Trocar K200517 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Standard Bariatrics. Cleared Apr 2020. https://www.510kdatabase.net/k200539/ 2020-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k200539-non-sterile-powder-free-nitrile-fda-510k.jpg K200539 - Non-sterile, Powder-Free Nitrile Examination Glove Tested for use with Chemotherapy Drugs and Fentanyl K200539 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sri Trang Gloves (Thailand) Public Company Limited. Cleared Apr 2020. https://www.510kdatabase.net/k200630/ 2020-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k200630-medtronic-external-drainage-and-fda-510k.jpg K200630 - Medtronic External Drainage and Monitoring System, Medtronic External Drainage and Monitoring System, Becker Replacement Drainage Bags K200630 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k200634/ 2020-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k200634-arrow-fiberoptix-intra-aortic-balloon-fda-510k.jpg K200634 - Arrow FiberOptix Intra-Aortic Balloon Catheter Kit K200634 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Arrow International, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k200688/ 2020-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k200688-hyperion-x5-newtom-go-x-radius-compact-fda-510k.jpg K200688 - hyperion X5, NewTom GO, X-RADiUS COMPACT K200688 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cefla S.C.. Cleared Apr 2020. https://www.510kdatabase.net/k200713/ 2020-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k200713-echonavigator-fda-510k.jpg K200713 - EchoNavigator K200713 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Apr 2020. https://www.510kdatabase.net/k191885/ 2020-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k191885-standard-bougie-fda-510k.jpg K191885 - Standard Bougie K191885 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Standard Bariatrics. Cleared Apr 2020. https://www.510kdatabase.net/k192108/ 2020-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k192108-panthera-dental-milled-bars-fda-510k.jpg K192108 - Panthera Dental Milled Bars K192108 is a FDA 510(k) cleared dental medical device. Manufacturer: Panthera Dental, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k192636/ 2020-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k192636-tyrx-neuro-absorbable-antibacterial-fda-510k.jpg K192636 - TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable Antibacterial Envelope (Large) K192636 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medtronic, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k193300/ 2020-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k193300-aimi-triage-cxr-ptx-fda-510k.jpg K193300 - AIMI-Triage CXR PTX K193300 is a FDA 510(k) cleared radiology medical device. Manufacturer: Radlogics, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k193571/ 2020-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k193571-go2wire-guide-wire-fda-510k.jpg K193571 - Go2Wire Guide Wire K193571 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical System, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k200144/ 2020-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k200144-hi-torque-steelcore-bare-guide-wire-fda-510k.jpg K200144 - HI-TORQUE Steelcore Bare Guide Wire K200144 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Vascular. Cleared Apr 2020. https://www.510kdatabase.net/k200282/ 2020-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k200282-orfit-aerial-couchtop-fda-510k.jpg K200282 - Orfit Aerial Couchtop K200282 is a FDA 510(k) cleared radiology medical device. Manufacturer: Orfit Industries NV. Cleared Apr 2020. https://www.510kdatabase.net/k200411/ 2020-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k200411-z6z60z60tz60sz60-prodp-60-diagnostic-fda-510k.jpg K200411 - Z6/Z60/Z60T/Z60S/Z60 Pro/DP-60 Diagnostic Ultrasound System K200411 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Apr 2020. https://www.510kdatabase.net/k200477/ 2020-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k200477-flex-body-speeder-fda-510k.jpg K200477 - Flex Body Speeder K200477 is a FDA 510(k) cleared radiology medical device. Manufacturer: Quality Electrodynamics, LLC. Cleared Apr 2020. https://www.510kdatabase.net/k200598/ 2020-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k200598-voyant-maryland-fusion-device-fda-510k.jpg K200598 - Voyant Maryland Fusion Device K200598 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Applied Medical Resources Corp.. Cleared Apr 2020. https://www.510kdatabase.net/k200632/ 2020-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k200632-tcat-tka-instrument-tray-set-fda-510k.jpg K200632 - TCAT TKA Instrument Tray Set K200632 is a FDA 510(k) cleared general hospital medical device. Manufacturer: THINK Surgical, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k191084/ 2020-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k191084-the-optimotion-blue-total-knee-system-fda-510k.jpg K191084 - The Optimotion Blue Total Knee System K191084 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Optimotion Implants, LLC. Cleared Apr 2020. https://www.510kdatabase.net/k192013/ 2020-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k192013-verticale-cervical-system-fda-510k.jpg K192013 - VERTICALE® Cervical System K192013 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Silony Medical GmbH. Cleared Apr 2020. https://www.510kdatabase.net/k193218/ 2020-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k193218-innovision-audio-fda-510k.jpg K193218 - Innovision Audio K193218 is a FDA 510(k) cleared radiology medical device. Manufacturer: Innovere Medical, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k193654/ 2020-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k193654-bluestar-rx-fda-510k.jpg K193654 - BlueStar Rx K193654 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Welldoc, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k200266/ 2020-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k200266-bd-centro-vena-acute-central-line-7-fda-510k.jpg K200266 - BD Centro Vena Acute Central Line (7 French Dual Lumen) K200266 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bard Access Systems, Inc. (Bard Has Joined Bd). Cleared Apr 2020. https://www.510kdatabase.net/k200339/ 2020-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k200339-hs40-diagnostic-ultrasound-system-fda-510k.jpg K200339 - HS40 Diagnostic Ultrasound System K200339 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Medison Co., Ltd.. Cleared Apr 2020. https://www.510kdatabase.net/k191422/ 2020-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k191422-neural-navigator-fda-510k.jpg K191422 - Neural Navigator K191422 is a FDA 510(k) cleared neurology medical device. Manufacturer: Soterix Medical, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k191970/ 2020-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k191970-diode-laser-hair-removal-system-fda-510k.jpg K191970 - Diode Laser Hair Removal System K191970 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Beijing Sano Laser S&T Development Co.,Ltd. Cleared Apr 2020. https://www.510kdatabase.net/k192401/ 2020-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k192401-straumann-screw-retained-abutments-fda-510k.jpg K192401 - Straumann Screw-Retained Abutments K192401 is a FDA 510(k) cleared dental medical device. Manufacturer: Straumann USA, LLC. Cleared Apr 2020. https://www.510kdatabase.net/k192500/ 2020-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k192500-aneroid-sphygmomanometer-with-fda-510k.jpg K192500 - Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer K192500 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Honsun (Nantong) Co., Ltd.. Cleared Apr 2020. https://www.510kdatabase.net/k192558/ 2020-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k192558-q3-distal-access-catheter-q4-distal-fda-510k.jpg K192558 - Q3 Distal Access Catheter, Q4 Distal Access Catheter, Q5 Distal Access Catheter, Q6Distal Access Catheter K192558 is a FDA 510(k) cleared neurology medical device. Manufacturer: Mivi Neurovascular. Cleared Apr 2020. https://www.510kdatabase.net/k193217/ 2020-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k193217-sensicare-pi-and-sensicare-pi-micro-fda-510k.jpg K193217 - SensiCare PI and SensiCare PI Micro Surgical Gloves K193217 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k193250/ 2020-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k193250-irrigation-tubing-with-co2-or-air-fda-510k.jpg K193250 - Irrigation Tubing with CO2 or Air K193250 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Keymed (Medical and Industrial Equipment) , Ltd.. Cleared Apr 2020. https://www.510kdatabase.net/k193494/ 2020-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k193494-origin-anterior-cervical-plate-system-fda-510k.jpg K193494 - Origin™ Anterior Cervical Plate System K193494 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthopaedic & Spine Development. Cleared Apr 2020. https://www.510kdatabase.net/k200019/ 2020-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k200019-nitrile-powder-free-examination-gloved-fda-510k.jpg K200019 - Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black) K200019 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hartalega NGC Sdn. Bhd.. Cleared Apr 2020. https://www.510kdatabase.net/k200023/ 2020-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k200023-gold-standard-diagnostics-borrelia-fda-510k.jpg K200023 - Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit K200023 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Gold Standard Diagnostics. Cleared Apr 2020. https://www.510kdatabase.net/k200025/ 2020-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k200025-gold-standard-diagnostics-borrelia-fda-510k.jpg K200025 - Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit K200025 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Gold Standard Diagnostics. Cleared Apr 2020. https://www.510kdatabase.net/k200199/ 2020-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k200199-advia-centaur-ca-125ii-fda-510k.jpg K200199 - ADVIA Centaur CA 125II K200199 is a FDA 510(k) cleared immunology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k200204/ 2020-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k200204-stat-profile-prime-plus-analyzer-system-fda-510k.jpg K200204 - Stat Profile Prime Plus Analyzer System K200204 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Nova Biomedical Corporation. Cleared Apr 2020. https://www.510kdatabase.net/k200308/ 2020-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k200308-mts-lefamulin-0016-256-gml-fda-510k.jpg K200308 - MTS Lefamulin 0.016- 256 µg/mL K200308 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Liofilchem S. R. 1.. Cleared Apr 2020. https://www.510kdatabase.net/k200312/ 2020-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k200312-tryptik-ti-fda-510k.jpg K200312 - Tryptik Ti K200312 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spineart. Cleared Apr 2020. https://www.510kdatabase.net/k200361/ 2020-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k200361-akros-scruture-anchor-lisfranc-repair-fda-510k.jpg K200361 - Akros Scruture Anchor LisFranc Repair Kit K200361 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Akros Medical. Cleared Apr 2020. https://www.510kdatabase.net/k200576/ 2020-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k200576-clearmask-transparent-surgical-face-mask-fda-510k.jpg K200576 - ClearMask Transparent Surgical Face Mask K200576 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Clearmask, LLC. Cleared Apr 2020. https://www.510kdatabase.net/k200776/ 2020-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k200776-eko-core-fda-510k.jpg K200776 - Eko CORE K200776 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Eko Devices, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k192015/ 2020-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k192015-faico-dental-implant-system-fda-510k.jpg K192015 - Faico Dental Implant System K192015 is a FDA 510(k) cleared dental medical device. Manufacturer: Faico Medical, LLC. Cleared Apr 2020. https://www.510kdatabase.net/k192719/ 2020-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k192719-osom-ultra-plus-flu-ab-test-kit-fda-510k.jpg K192719 - Osom Ultra Plus Flu A&B Test Kit K192719 is a FDA 510(k) cleared microbiology medical device. Manufacturer: SEKISUI Diagnostics, LLC. Cleared Apr 2020. https://www.510kdatabase.net/k192735/ 2020-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k192735-diode-laser-hair-removal-machine-fda-510k.jpg K192735 - Diode Laser Hair Removal Machine K192735 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Beijing Lead Beauty S & T Co., Ltd.. Cleared Apr 2020. https://www.510kdatabase.net/k193026/ 2020-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k193026-visera-elite-ii-video-system-center-fda-510k.jpg K193026 - Visera Elite II Video System Center, Visera Elite II Endoeye 3D K193026 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Apr 2020. https://www.510kdatabase.net/k200022/ 2020-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k200022-flusion-9001-fluoroscopic-c-arm-mobile-fda-510k.jpg K200022 - FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System K200022 is a FDA 510(k) cleared radiology medical device. Manufacturer: Livermoretech, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k200564/ 2020-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k200564-aria-system-fda-510k.jpg K200564 - Aria System K200564 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inova Labs. Cleared Apr 2020. https://www.510kdatabase.net/k200566/ 2020-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k200566-adapt-tissue-fda-510k.jpg K200566 - ADAPT Tissue K200566 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Admedus Regen Pty, Ltd.. Cleared Apr 2020. https://www.510kdatabase.net/k200577/ 2020-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k200577-ras-12-rack-ras-12-long-rack-ras-cycle-fda-510k.jpg K200577 - RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector K200577 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Apr 2020. https://www.510kdatabase.net/k200608/ 2020-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k200608-eclipse-treatment-planning-system-v160-fda-510k.jpg K200608 - Eclipse Treatment Planning System v16.0 K200608 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k200638/ 2020-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k200638-lap-ix-suction-irrigation-fda-510k.jpg K200638 - LAP-iX Suction Irrigation K200638 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sejong Medical Co., Ltd.. Cleared Apr 2020. https://www.510kdatabase.net/k192006/ 2020-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k192006-sirion-lateral-lumbar-interbody-system-fda-510k.jpg K192006 - SIRION Lateral Lumbar Interbody System K192006 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Astura Medical, LLC. Cleared Apr 2020. https://www.510kdatabase.net/k192099/ 2020-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k192099-med-i-bone-marrow-aspiration-needle-fda-510k.jpg K192099 - MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System K192099 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medax Srl Unipersonale. Cleared Apr 2020. https://www.510kdatabase.net/k192101/ 2020-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k192101-medone-ultra-medextra-fda-510k.jpg K192101 - Medone Ultra, Medextra K192101 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medax Srl Unipersonale. Cleared Apr 2020. https://www.510kdatabase.net/k192176/ 2020-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k192176-intelepacs-fda-510k.jpg K192176 - IntelePACS K192176 is a FDA 510(k) cleared radiology medical device. Manufacturer: Intelerad Medical Systems Incorporated. Cleared Apr 2020. https://www.510kdatabase.net/k192445/ 2020-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k192445-qwikcheck-chemical-indicators-fda-510k.jpg K192445 - QwikCheck Chemical Indicators K192445 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Serim Research Corporation. Cleared Apr 2020. https://www.510kdatabase.net/k192514/ 2020-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k192514-patient-monitor-fda-510k.jpg K192514 - Patient Monitor K192514 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edan Instruments, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k192646/ 2020-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k192646-symphony-oct-system-fda-510k.jpg K192646 - SYMPHONY™ OCT System K192646 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International SARL. Cleared Apr 2020. https://www.510kdatabase.net/k192958/ 2020-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k192958-twitchview-system-fda-510k.jpg K192958 - TwitchView System K192958 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Blink Device Company. Cleared Apr 2020. https://www.510kdatabase.net/k193027/ 2020-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k193027-esophageal-stethoscope-9-french-fda-510k.jpg K193027 - Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French K193027 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Deroyal Industries, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k193095/ 2020-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k193095-ambu-ascope-4-cysto-fda-510k.jpg K193095 - Ambu aScope 4 Cysto K193095 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ambu A/S. Cleared Apr 2020. https://www.510kdatabase.net/k193322/ 2020-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k193322-novacross-cto-microcatheter-fda-510k.jpg K193322 - NovaCross CTO Microcatheter K193322 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nitiloop , Ltd.. Cleared Apr 2020. https://www.510kdatabase.net/k193390/ 2020-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k193390-cs-model-fda-510k.jpg K193390 - CS Model+ K193390 is a FDA 510(k) cleared dental medical device. Manufacturer: Trophy. Cleared Apr 2020. https://www.510kdatabase.net/k193591/ 2020-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k193591-arc-400-fda-510k.jpg K193591 - ARC 400 K193591 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bowa-Electronics GmbH & Co. KG. Cleared Apr 2020. https://www.510kdatabase.net/k200010/ 2020-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k200010-filmarray-bcid2-control-panel-m416-fda-510k.jpg K200010 - FilmArray BCID2 Control Panel M416 K200010 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Maine Molecular Quality Controls, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k200251/ 2020-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k200251-z5z50z50tz50sz50-pro-diagnostic-fda-510k.jpg K200251 - Z5/Z50/Z50T/Z50S/Z50 Pro Diagnostic Ultrasound System K200251 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Apr 2020. https://www.510kdatabase.net/k200319/ 2020-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k200319-hydro-temp-neonatal-skin-surface-fda-510k.jpg K200319 - HYDRO-TEMP Neonatal Skin Surface Temperature Sensor, HYDRO-TEMP Neonatal Skin Surface Temperature Sensor with Interface Cable K200319 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Deroyal Industries, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k200552/ 2020-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k200552-evos-lumbar-interbody-system-fda-510k.jpg K200552 - EVOS Lumbar Interbody System K200552 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Cutting Edge Spine, LLC. Cleared Apr 2020. https://www.510kdatabase.net/k200696/ 2020-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k200696-firebird-si-fusion-system-fda-510k.jpg K200696 - FIREBIRD SI Fusion System K200696 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthofix, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k191065/ 2020-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k191065-venus-vivatm-fda-510k.jpg K191065 - Venus VivaTM K191065 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Venus Concept USA, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k191762/ 2020-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k191762-magnetic-surgical-system-fda-510k.jpg K191762 - Magnetic Surgical System K191762 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Levita Magnetics International Corp. Cleared Apr 2020. https://www.510kdatabase.net/k192228/ 2020-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k192228-cs-medical-td-200-disinfector-with-td-fda-510k.jpg K192228 - CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant K192228 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cs Medical, LLC. Cleared Apr 2020. https://www.510kdatabase.net/k192658/ 2020-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k192658-manual-wheelchair-fda-510k.jpg K192658 - Manual Wheelchair K192658 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Jerry Medical Instrument (Shanghai) Co., Ltd.. Cleared Apr 2020. https://www.510kdatabase.net/k192676/ 2020-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k192676-introcan-safety-2-iv-catheter-18-24-fda-510k.jpg K192676 - Introcan Safety 2 IV Catheter 18-24 gauge K192676 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k192988/ 2020-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k192988-dermasure-green-sterile-fda-510k.jpg K192988 - Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for Use K192988 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k193580/ 2020-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k193580-verasense-for-zimmer-biomet-persona-cr-fda-510k.jpg K193580 - VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left K193580 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthosensor, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k200119/ 2020-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k200119-logiq-e10s-fda-510k.jpg K200119 - LOGIQ E10s K200119 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared Apr 2020. https://www.510kdatabase.net/k200188/ 2020-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k200188-dsi-dental-implant-system-fda-510k.jpg K200188 - DSI Dental Implant System K200188 is a FDA 510(k) cleared dental medical device. Manufacturer: Dsi Dental Solutions, Ltd.. Cleared Apr 2020. https://www.510kdatabase.net/k200524/ 2020-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k200524-somatom-xcite-scango-somatom-fda-510k.jpg K200524 - SOMATOM X.cite, Scan&GO, SOMATOM go.Platform - go.Up, go.Now, go.Top, go.All, go. Sim, go. Open Pro, Scan&GO K200524 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 2020. https://www.510kdatabase.net/k200622/ 2020-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k200622-focus-43c-detector-trimax-43c-detector-fda-510k.jpg K200622 - Focus 43C detector, TRIMAX 43C detector K200622 is a FDA 510(k) cleared radiology medical device. Manufacturer: Iray Technology Taicang , Ltd.. Cleared Apr 2020. https://www.510kdatabase.net/k183086/ 2020-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k183086-da-vinci-x-and-xi-surgical-system-fda-510k.jpg K183086 - da Vinci X and Xi Surgical System K183086 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k191860/ 2020-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k191860-sterile-powder-free-synthetic-rubber-fda-510k.jpg K191860 - Sterile Powder-Free Synthetic Rubber Surgeon’s Glove with Low Dermatitis Potential K191860 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Semperit Technische Produkte Gesellchaft M.B.H.. Cleared Mar 2020. https://www.510kdatabase.net/k191868/ 2020-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k191868-icewav-neuromonitoring-platform-fda-510k.jpg K191868 - iCEWav Neuromonitoring Platform K191868 is a FDA 510(k) cleared neurology medical device. Manufacturer: Ice Neurosystems, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k192413/ 2020-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k192413-siteseal-femoral-compression-device-fda-510k.jpg K192413 - SiteSeal Femoral Compression Device K192413 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ensite Vacular, LLC. Cleared Mar 2020. https://www.510kdatabase.net/k192818/ 2020-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k192818-vertaplex-hv-high-viscosity-radiopaque-fda-510k.jpg K192818 - Vertaplex HV High Viscosity Radiopaque Bone Cement K192818 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Corporation. Cleared Mar 2020. https://www.510kdatabase.net/k193054/ 2020-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k193054-sectra-digital-pathology-module-fda-510k.jpg K193054 - Sectra Digital Pathology Module K193054 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sectra AB. Cleared Mar 2020. https://www.510kdatabase.net/k193087/ 2020-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k193087-rapid-ich-fda-510k.jpg K193087 - Rapid ICH K193087 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ischemaview Incorporated. Cleared Mar 2020. https://www.510kdatabase.net/k193524/ 2020-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k193524-si-bone-ifuse-implant-system-fda-510k.jpg K193524 - SI-BONE iFuse Implant System® K193524 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SI-BONE, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k200278/ 2020-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k200278-cytocore-fda-510k.jpg K200278 - CytoCore K200278 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Praxis Medical, LLC. Cleared Mar 2020. https://www.510kdatabase.net/k200281/ 2020-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k200281-the-gecko-spinal-system-fda-510k.jpg K200281 - The Gecko Spinal System K200281 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ortho Development Corporation. Cleared Mar 2020. https://www.510kdatabase.net/k200455/ 2020-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k200455-trigger-switch-and-cord-fda-510k.jpg K200455 - Trigger Switch and Cord K200455 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: New Deantronics Taiwan , Ltd.. Cleared Mar 2020. https://www.510kdatabase.net/k200556/ 2020-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k200556-aquaflate-pre-filled-sterile-water-fda-510k.jpg K200556 - AquaFlate Pre-Filled Sterile Water Syringe 10mL K200556 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: H R Pharmaceuticals, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k200741/ 2020-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k200741-tablo-hemodialysis-system-fda-510k.jpg K200741 - Tablo Hemodialysis System K200741 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Outset Medical, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k173590/ 2020-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k173590-system-83-plus-washerdisinfector-fda-510k.jpg K173590 - System 83 Plus Washer/Disinfector K173590 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Custom Ultrasonics, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k192490/ 2020-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k192490-tevdek-ii-silky-ii-polydek-cottony-ii-fda-510k.jpg K192490 - Tevdek II, Silky II Polydek, 'Cottony' II, NextStitch K192490 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Teleflex Medical. Cleared Mar 2020. https://www.510kdatabase.net/k192640/ 2020-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k192640-kidro-digital-electric-breast-pump-dr-fda-510k.jpg K192640 - Kidro Digital Electric Breast Pump, Dr. Brown's Digital Electric Breast Pump K192640 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Guangzhou Yongyi Industrial Co., Ltd.. Cleared Mar 2020. https://www.510kdatabase.net/k193144/ 2020-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k193144-t-line-hernia-mesh-fda-510k.jpg K193144 - T-Line Hernia Mesh K193144 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Deep Blue Medical Advances, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k193487/ 2020-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k193487-agilon-strip-fda-510k.jpg K193487 - Agilon Strip K193487 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biogennix, LLC. Cleared Mar 2020. https://www.510kdatabase.net/k193541/ 2020-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k193541-nuvasive-cohere-thoracolumbar-fda-510k.jpg K193541 - NuVasive Cohere Thoracolumbar Interbody System K193541 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Mar 2020. https://www.510kdatabase.net/k200040/ 2020-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k200040-universal-base-conical-connection-cc-fda-510k.jpg K200040 - Universal Base Conical Connection (CC) K200040 is a FDA 510(k) cleared dental medical device. Manufacturer: Nobel Biocare AG. Cleared Mar 2020. https://www.510kdatabase.net/k192039/ 2020-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k192039-torc-body-fda-510k.jpg K192039 - Torc Body K192039 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Johari Digital Healthcare Limited. Cleared Mar 2020. https://www.510kdatabase.net/k200494/ 2020-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k200494-carescape-one-and-carescape-dock-fo-fda-510k.jpg K200494 - CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES K200494 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Healthcare. Cleared Mar 2020. https://www.510kdatabase.net/k200499/ 2020-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k200499-quickdraw-venous-cannula-fda-510k.jpg K200499 - QuickDraw Venous Cannula K200499 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Mar 2020. https://www.510kdatabase.net/k192852/ 2020-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k192852-mri-ecg-patient-cable-fda-510k.jpg K192852 - MRI ECG Patient Cable K192852 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ivy Biomedical Systems, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k190091/ 2020-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k190091-diapaste-fda-510k.jpg K190091 - Diapaste K190091 is a FDA 510(k) cleared dental medical device. Manufacturer: DiaDent Group International. Cleared Mar 2020. https://www.510kdatabase.net/k191401/ 2020-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k191401-pregsense-fda-510k.jpg K191401 - PregSense K191401 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Nuvo- Group , Ltd.. Cleared Mar 2020. https://www.510kdatabase.net/k191900/ 2020-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k191900-single-use-grasping-forceps-fda-510k.jpg K191900 - Single Use Grasping Forceps K191900 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Zhejiang Chuangxiang Medical Technology Co., Ltd.. Cleared Mar 2020. https://www.510kdatabase.net/k191912/ 2020-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k191912-biwaze-cough-fda-510k.jpg K191912 - BiWaze Cough K191912 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Abmrc, LLC. Cleared Mar 2020. https://www.510kdatabase.net/k192056/ 2020-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k192056-jj-series-container-system-fda-510k.jpg K192056 - JJ Series Container System K192056 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Aesculap, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k192240/ 2020-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k192240-rapidpoint-500e-blood-gas-system-fda-510k.jpg K192240 - RAPIDPoint 500e Blood Gas System K192240 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k192389/ 2020-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k192389-tyrx-absorbable-antibacterial-envelope-fda-510k.jpg K192389 - TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large) K192389 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medtronic, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k193052/ 2020-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k193052-hbp6-settable-resorbable-hemostatic-fda-510k.jpg K193052 - HBP6 Settable, Resorbable Hemostatic Bone Paste K193052 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Orthocon, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k193200/ 2020-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k193200-umr-omega-fda-510k.jpg K193200 - uMR Omega K193200 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Mar 2020. https://www.510kdatabase.net/k193656/ 2020-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k193656-skypulse-fda-510k.jpg K193656 - SkyPulse K193656 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Fotona D.O.O.. Cleared Mar 2020. https://www.510kdatabase.net/k200140/ 2020-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k200140-silhouette-instalift-fda-510k.jpg K200140 - Silhouette Instalift K200140 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Silhouette Lift, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k200294/ 2020-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k200294-grandioso-light-flow-fda-510k.jpg K200294 - GrandioSO Light Flow K200294 is a FDA 510(k) cleared dental medical device. Manufacturer: Voco GmbH. Cleared Mar 2020. https://www.510kdatabase.net/k200482/ 2020-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k200482-stimrouter-neuromodulation-system-fda-510k.jpg K200482 - StimRouter Neuromodulation System K200482 is a FDA 510(k) cleared neurology medical device. Manufacturer: Bioness, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k200548/ 2020-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k200548-cubescan-biocon-1100-fda-510k.jpg K200548 - CUBEScan BioCon-1100 K200548 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mcube Technology Co., Ltd.. Cleared Mar 2020. https://www.510kdatabase.net/k191558/ 2020-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k191558-konan-specular-microscope-xvii-fda-510k.jpg K191558 - Konan Specular Microscope XVII K191558 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Konan Medical, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k191749/ 2020-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k191749-tigr-matrix-surgical-mesh-tigr-fda-510k.jpg K191749 - TIGR Matrix Surgical Mesh, TIGR Surgical Mesh K191749 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Novus Scientific AB. Cleared Mar 2020. https://www.510kdatabase.net/k191830/ 2020-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k191830-gammacore-sapphire-fda-510k.jpg K191830 - gammaCore Sapphire K191830 is a FDA 510(k) cleared neurology medical device. Manufacturer: Electrocore, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k192724/ 2020-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k192724-propeller-sensor-for-symbicort-fda-510k.jpg K192724 - Propeller Sensor for Symbicort K192724 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Reciprocal Labs Corporation. Cleared Mar 2020. https://www.510kdatabase.net/k192732/ 2020-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k192732-bodyguardian-remote-monitoring-system-fda-510k.jpg K192732 - BodyGuardian Remote Monitoring System K192732 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Preventice Technologies, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k192886/ 2020-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k192886-omniwire-pressure-guide-wire-185-cm-fda-510k.jpg K192886 - OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip K192886 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Volcano Corporation. Cleared Mar 2020. https://www.510kdatabase.net/k192951/ 2020-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k192951-ellipse-frax-1940-for-ellipse-nordlys-fda-510k.jpg K192951 - Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun K192951 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ellipse A/S. Cleared Mar 2020. https://www.510kdatabase.net/k192987/ 2020-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k192987-aina-hba1c-monitoring-system-2-fda-510k.jpg K192987 - Aina HbA1c Monitoring System 2 K192987 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Jana Care, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k193053/ 2020-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k193053-tina-quant-hemoglobin-a1cdx-gen3-fda-510k.jpg K193053 - Tina-quant Hemoglobin A1cDx Gen.3 K193053 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Operations (Rdo). Cleared Mar 2020. https://www.510kdatabase.net/k193108/ 2020-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k193108-bonecam-suture-anchor-fda-510k.jpg K193108 - Bonecam Suture Anchor K193108 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Valeris Medical, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k193136/ 2020-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k193136-stryker-customized-mandible-recon-fda-510k.jpg K193136 - Stryker Customized Mandible Recon Plate Kit K193136 is a FDA 510(k) cleared dental medical device. Manufacturer: Stryker. Cleared Mar 2020. https://www.510kdatabase.net/k193143/ 2020-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k193143-stryker-facial-id-plating-system-fda-510k.jpg K193143 - Stryker Facial iD Plating System K193143 is a FDA 510(k) cleared dental medical device. Manufacturer: Stryker. Cleared Mar 2020. https://www.510kdatabase.net/k193518/ 2020-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k193518-kosmos-fda-510k.jpg K193518 - KOSMOS K193518 is a FDA 510(k) cleared radiology medical device. Manufacturer: EchoNous, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k193633/ 2020-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k193633-aptus-ankle-trauma-system-2835-fda-510k.jpg K193633 - APTUS® Ankle Trauma System 2.8/3.5 K193633 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medartis AG. Cleared Mar 2020. https://www.510kdatabase.net/k193639/ 2020-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k193639-aptus-foot-28-35-system-fda-510k.jpg K193639 - APTUS® Foot 2.8-3.5 System K193639 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medartis AG. Cleared Mar 2020. https://www.510kdatabase.net/k193652/ 2020-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k193652-abclose-port-site-closure-device-fda-510k.jpg K193652 - AbClose - Port Site Closure Device K193652 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medeon Biodesign, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k200108/ 2020-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k200108-geo-1st-mtp-joint-arthrodesis-plating-fda-510k.jpg K200108 - GEO 1st MTP Joint Arthrodesis Plating System K200108 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Gramercy Extremity Orthopedics, LLC. Cleared Mar 2020. https://www.510kdatabase.net/k200456/ 2020-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k200456-becker-external-drainage-and-fda-510k.jpg K200456 - Becker External Drainage and Monitoring System K200456 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k192008/ 2020-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k192008-lasershot-m-navilase-fda-510k.jpg K192008 - LaserShot M, NaviLase K192008 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Vitrolife GmbH. Cleared Mar 2020. https://www.510kdatabase.net/k192144/ 2020-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k192144-stratafix-spiral-pds-plus-fda-510k.jpg K192144 - STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device K192144 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k192284/ 2020-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k192284-diafil-flow-fda-510k.jpg K192284 - DiaFil Flow K192284 is a FDA 510(k) cleared dental medical device. Manufacturer: DiaDent Group International. Cleared Mar 2020. https://www.510kdatabase.net/k192437/ 2020-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k192437-arterys-mica-fda-510k.jpg K192437 - Arterys MICA K192437 is a FDA 510(k) cleared radiology medical device. Manufacturer: Arterys, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k192534/ 2020-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k192534-crossbay-endometrial-tissue-sampler-ets-fda-510k.jpg K192534 - CrossBay Endometrial Tissue Sampler (ETS) K192534 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Crossbay Medical. Cleared Mar 2020. https://www.510kdatabase.net/k192854/ 2020-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k192854-mammoscreen-fda-510k.jpg K192854 - MammoScreen K192854 is a FDA 510(k) cleared radiology medical device. Manufacturer: Therapixel. Cleared Mar 2020. https://www.510kdatabase.net/k192967/ 2020-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k192967-medacta-shoulder-system-fda-510k.jpg K192967 - Medacta Shoulder System K192967 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Mar 2020. https://www.510kdatabase.net/k193078/ 2020-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k193078-mis-connect-conical-connection-system-fda-510k.jpg K193078 - MIS CONNECT Conical Connection System K193078 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona. Cleared Mar 2020. https://www.510kdatabase.net/k193311/ 2020-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k193311-aluna-fda-510k.jpg K193311 - Aluna K193311 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Knox Medical Diagnostics, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k193328/ 2020-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k193328-ipl-diode-laser-machine-fda-510k.jpg K193328 - IPL + Diode Laser Machine K193328 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Beijing Globalipl Development Co., Ltd.. Cleared Mar 2020. https://www.510kdatabase.net/k193593/ 2020-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k193593-nuvasive-3dp-interfixated-alif-system-fda-510k.jpg K193593 - NuVasive 3DP Interfixated ALIF System K193593 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Mar 2020. https://www.510kdatabase.net/k193614/ 2020-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k193614-fine-osteotomy-around-the-knee-fda-510k.jpg K193614 - FINE Osteotomy around the knee K193614 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Bodycad Laboratories, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k193615/ 2020-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k193615-northstar-oct-spinal-system-fda-510k.jpg K193615 - NorthStar™ OCT Spinal System K193615 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared Mar 2020. https://www.510kdatabase.net/k193619/ 2020-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k193619-cry-ac-cry-ac-3-cry-baby-fda-510k.jpg K193619 - Cry-Ac®, Cry-Ac-3®, Cry-Baby K193619 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Brymill Cryogenic Systems. Cleared Mar 2020. https://www.510kdatabase.net/k193629/ 2020-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k193629-disposable-nibp-cuff-fda-510k.jpg K193629 - Disposable NIBP Cuff K193629 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Changke Connect Electronics Co., Ltd.. Cleared Mar 2020. https://www.510kdatabase.net/k193661/ 2020-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k193661-lightwalker-laser-system-family-fda-510k.jpg K193661 - LightWalker Laser System Family K193661 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Fotona D.O.O.. Cleared Mar 2020. https://www.510kdatabase.net/k193667/ 2020-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k193667-shapiro-md-model-laser-272-fda-510k.jpg K193667 - Shapiro MD model laser 272 K193667 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Conversion Labs, Pr, LLC. Cleared Mar 2020. https://www.510kdatabase.net/k200241/ 2020-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k200241-tempsure-system-fda-510k.jpg K200241 - TempSure System K200241 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cynosure, LLC. Cleared Mar 2020. https://www.510kdatabase.net/k200515/ 2020-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k200515-syngoct-cardiac-planning-fda-510k.jpg K200515 - syngo.CT Cardiac Planning K200515 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Soultions USA, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k193100/ 2020-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k193100-response-spine-system-response-4550-fda-510k.jpg K193100 - RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine System K193100 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OrthoPediatrics Corp.. Cleared Mar 2020. https://www.510kdatabase.net/k193145/ 2020-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k193145-ethicon-megadyne-electrosurgical-fda-510k.jpg K193145 - Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch K193145 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Megadyne Medical Products, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k193335/ 2020-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k193335-sherlock-fda-510k.jpg K193335 - Sherlock K193335 is a FDA 510(k) cleared dental medical device. Manufacturer: Open Implants, LLC. Cleared Mar 2020. https://www.510kdatabase.net/k193579/ 2020-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k193579-plasmablade-x-30s-light-fda-510k.jpg K193579 - PlasmaBlade X 3.0S LIGHT K193579 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medtronic Navigation. Cleared Mar 2020. https://www.510kdatabase.net/k200209/ 2020-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k200209-persona-personalized-knee-system-fda-510k.jpg K200209 - Persona Personalized Knee System K200209 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k200224/ 2020-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k200224-sea-link-anterior-cervical-plate-system-fda-510k.jpg K200224 - SEA-LINK Anterior Cervical Plate System K200224 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Indius Medical Technologies Pvt. , Ltd.. Cleared Mar 2020. https://www.510kdatabase.net/k200337/ 2020-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k200337-flopatch-fp120-fda-510k.jpg K200337 - FloPatch (FP120) K200337 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Flosonics Medical (R/A 1929803 Ontario Corp.). Cleared Mar 2020. https://www.510kdatabase.net/k191716/ 2020-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k191716-somryst-fda-510k.jpg K191716 - Somryst K191716 is a FDA 510(k) cleared neurology medical device. Manufacturer: Pear Therapeutics, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k191763/ 2020-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k191763-myday-stenfilcon-a-asphere-myday-fda-510k.jpg K191763 - MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) MULTIFOCAL, MyDay (Stenfilcon A) MULTIFOCAL TORIC K191763 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: CooperVision, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k191788/ 2020-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k191788-capstone-spinal-system-clydesdale-ptc-fda-510k.jpg K191788 - CAPSTONE Spinal System, CLYDESDALE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium, DIVERGENCE-L Anterior/Oblique Lumbar Fusion System K191788 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k191909/ 2020-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k191909-hepashield-bacterial-viral-breathing-fda-510k.jpg K191909 - HepaShield Bacterial Viral Breathing System Filter K191909 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Flexicare Medical Limited.. Cleared Mar 2020. https://www.510kdatabase.net/k193453/ 2020-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k193453-trudi-probe-fda-510k.jpg K193453 - TruDi Probe K193453 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Acclarent, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k193479/ 2020-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k193479-sternal-cable-system-fda-510k.jpg K193479 - Sternal Cable System K193479 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: A & E Medical Corporation. Cleared Mar 2020. https://www.510kdatabase.net/k200043/ 2020-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k200043-field-orthopaedics-bony-trauma-fda-510k.jpg K200043 - Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws K200043 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Field Orthopaedics Pty, Ltd.. Cleared Mar 2020. https://www.510kdatabase.net/k200436/ 2020-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k200436-aptima-combo-2-assay-panther-250-test-fda-510k.jpg K200436 - Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test kit, Aptima Trichomonas Vaginalis (Panther) - 250 test kit, Aptima Trichomonas Vaginalis (Tigris) - 250 test kit K200436 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Hologic, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k200485/ 2020-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k200485-radiforce-rx1270-radiforce-rx1270-ar-fda-510k.jpg K200485 - RadiForce RX1270, RadiForce RX1270-AR K200485 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eizo Corporation. Cleared Mar 2020. https://www.510kdatabase.net/k200543/ 2020-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k200543-nexxt-matrixx-stand-alone-cervical-fda-510k.jpg K200543 - NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System K200543 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nexxt Spine, LLC. Cleared Mar 2020. https://www.510kdatabase.net/k200493/ 2020-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k200493-stryker-t7-surgical-hoods-stryker-t7-fda-510k.jpg K200493 - Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7 Surgical Togas, Zippered with Peel Away Face Shield, Stryker T7 Surgical Togas, Pullover K200493 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Stryker Corporation. Cleared Mar 2020. https://www.510kdatabase.net/k191612/ 2020-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k191612-encision-aem-monopolar-laparoscopic-fda-510k.jpg K191612 - Encision AEM Monopolar Laparoscopic Instruments and Accessories K191612 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Encision Incorporated. Cleared Mar 2020. https://www.510kdatabase.net/k191657/ 2020-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k191657-bioland-blood-glucose-monitoring-system-fda-510k.jpg K191657 - Bioland Blood Glucose Monitoring System K191657 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bioland Technology, Ltd.. Cleared Mar 2020. https://www.510kdatabase.net/k191680/ 2020-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k191680-azur-vascular-plug-fda-510k.jpg K191680 - AZUR Vascular Plug K191680 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: MicroVention, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k191735/ 2020-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k191735-cpt-hip-system-fda-510k.jpg K191735 - CPT Hip System K191735 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k191838/ 2020-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k191838-clearform-aligners-fda-510k.jpg K191838 - Clearform Aligners K191838 is a FDA 510(k) cleared dental medical device. Manufacturer: Motor City Lab Works. Cleared Mar 2020. https://www.510kdatabase.net/k192300/ 2020-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k192300-enlightenvue-microendoscopy-system-fda-510k.jpg K192300 - EnlightenVue Microendoscopy System K192300 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Enlightenvue, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k192510/ 2020-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k192510-diafil-diafil-capsule-fda-510k.jpg K192510 - DIAFIL & DIAFIL Capsule K192510 is a FDA 510(k) cleared dental medical device. Manufacturer: DiaDent Group International. Cleared Mar 2020. https://www.510kdatabase.net/k192897/ 2020-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k192897-icotec-cervical-cage-fda-510k.jpg K192897 - icotec Cervical Cage K192897 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Icotec AG. Cleared Mar 2020. https://www.510kdatabase.net/k193089/ 2020-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k193089-multix-impact-fda-510k.jpg K193089 - MULTIX Impact K193089 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k193121/ 2020-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k193121-gen-2-nitrile-examination-glove-blue-fda-510k.jpg K193121 - GEN 2 Nitrile Examination Glove (Blue) With Low Dermatitis Potential Claim and with tested for use with Chemotherapy Drugs Claims K193121 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Eco Medi Glove Sdn. Bhd.. Cleared Mar 2020. https://www.510kdatabase.net/k193183/ 2020-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k193183-acist-hdi-system-acist-kodama-fda-510k.jpg K193183 - ACIST HDi System, ACIST Kodama Intravascular Ultrasound Catheter K193183 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Acist Medical Systems, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k193211/ 2020-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k193211-nano-fortifix-system-fda-510k.jpg K193211 - Nano FortiFix® System K193211 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nanovis Spine, LLC. Cleared Mar 2020. https://www.510kdatabase.net/k193281/ 2020-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k193281-hepatic-vcar-fda-510k.jpg K193281 - Hepatic VCAR K193281 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems SCS. Cleared Mar 2020. https://www.510kdatabase.net/k193327/ 2020-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k193327-cardinal-health-chemoplus-full-fda-510k.jpg K193327 - Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve K193327 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cardinal Health200, LLC. Cleared Mar 2020. https://www.510kdatabase.net/k193366/ 2020-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k193366-t2-icf-fda-510k.jpg K193366 - T2 ICF K193366 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker GmbH. Cleared Mar 2020. https://www.510kdatabase.net/k193560/ 2020-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k193560-materialise-shoulder-guide-and-models-fda-510k.jpg K193560 - Materialise Shoulder Guide and Models, Materialise SurgiCase Shoulder Planner, Materialise Shoulder Planner, SurgiCase Shoulder Planner, SurgiCase Planner K193560 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Materialise NV. Cleared Mar 2020. https://www.510kdatabase.net/k193581/ 2020-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k193581-non-sterile-powder-free-nitrile-exam-fda-510k.jpg K193581 - Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Lilac, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Orchid, Non-Sterile, Powder Free Nitrile Exam Glove Tested for use with Chemotherapy Drugs - Oyster K193581 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sri Trang Gloves (Thailand) Public Company Limited. Cleared Mar 2020. https://www.510kdatabase.net/k193609/ 2020-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k193609-q-switched-nd-yag-laser-machine-fda-510k.jpg K193609 - Q Switched Nd: YAG Laser machine K193609 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Beijing Lead Beauty S & T Co., Ltd.. Cleared Mar 2020. https://www.510kdatabase.net/k193659/ 2020-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k193659-itero-element-5d-fda-510k.jpg K193659 - iTero Element 5D K193659 is a FDA 510(k) cleared dental medical device. Manufacturer: Align Technology, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k200036/ 2020-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k200036-ai-ecg-tracker-fda-510k.jpg K200036 - AI-ECG Tracker K200036 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Carewell Electronics Co., Ltd.. Cleared Mar 2020. https://www.510kdatabase.net/k200180/ 2020-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k200180-mts-omadacycline-0002-32-ugml-fda-510k.jpg K200180 - MTS Omadacycline 0.002 - 32 ug/mL K200180 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Liofilchem S. R. L.. Cleared Mar 2020. https://www.510kdatabase.net/k200474/ 2020-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k200474-symbia-67-fda-510k.jpg K200474 - Symbia 6.7 K200474 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k191057/ 2020-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k191057-parks-pectus-system-fda-510k.jpg K191057 - Park's Pectus System K191057 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tdm Co., Ltd.. Cleared Mar 2020. https://www.510kdatabase.net/k191658/ 2020-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k191658-iv-sets-not-made-with-pvc-fda-510k.jpg K191658 - IV Sets not made with PVC K191658 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k191818/ 2020-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k191818-fp-optiflow-3s-nasal-cannula-small-fda-510k.jpg K191818 - F&P Optiflow 3S Nasal Cannula (Small, Medium, Large) K191818 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Fisher &Paykel Healthcare , Ltd.. Cleared Mar 2020. https://www.510kdatabase.net/k191856/ 2020-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k191856-compression-therapy-device-fda-510k.jpg K191856 - Compression Therapy Device K191856 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Guangzhou Longest Science & Technology Co., Ltd.. Cleared Mar 2020. https://www.510kdatabase.net/k192905/ 2020-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k192905-creo-electrosurgical-system-with-hs1-fda-510k.jpg K192905 - Creo Electrosurgical System with HS1 Hemostasis Accessory K192905 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Creo Medical, Ltd.. Cleared Mar 2020. https://www.510kdatabase.net/k193059/ 2020-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k193059-g1-40-radiopaque-bone-cement-fda-510k.jpg K193059 - G1 40 Radiopaque Bone Cement K193059 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: G21, S.R.L.. Cleared Mar 2020. https://www.510kdatabase.net/k193061/ 2020-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k193061-g3-40-radiopaque-bone-cement-fda-510k.jpg K193061 - G3 40 Radiopaque Bone Cement K193061 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: G21, S.R.L.. Cleared Mar 2020. https://www.510kdatabase.net/k193491/ 2020-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k193491-restor3d-metallic-interference-screw-fda-510k.jpg K193491 - restor3d Metallic Interference Screw K193491 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Restor3d. Cleared Mar 2020. https://www.510kdatabase.net/k193530/ 2020-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k193530-deklene-maxx-fda-510k.jpg K193530 - Deklene MAXX K193530 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Teleflex Medical. Cleared Mar 2020. https://www.510kdatabase.net/k200379/ 2020-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k200379-super-sheath-fda-510k.jpg K200379 - Super Sheath K200379 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Togo Medikit Co., Ltd.. Cleared Mar 2020. https://www.510kdatabase.net/k191027/ 2020-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k191027-flow-i-anesthesia-system-flow-c-fda-510k.jpg K191027 - Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System K191027 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Maquet Critical Care AB. Cleared Mar 2020. https://www.510kdatabase.net/k191876/ 2020-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k191876-pulmoscan-fda-510k.jpg K191876 - PulmoScan K191876 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Cognita Labs, LLC. Cleared Mar 2020. https://www.510kdatabase.net/k193517/ 2020-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k193517-vizishot-2-flex-fda-510k.jpg K193517 - ViziShot 2 FLEX K193517 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Olympus Surgical Technologies America. Cleared Mar 2020. https://www.510kdatabase.net/k193519/ 2020-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k193519-biofire-blood-culture-identification-2-fda-510k.jpg K193519 - BioFire Blood Culture Identification 2 (BCID2) Panel K193519 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Biofire Diagnostics, LLC. Cleared Mar 2020. https://www.510kdatabase.net/k193536/ 2020-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k193536-microscan-dried-gram-negative-miccombo-fda-510k.jpg K193536 - MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL) K193536 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k193558/ 2020-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k193558-healicoil-knotless-suture-anchors-fda-510k.jpg K193558 - HEALICOIL Knotless Suture Anchors K193558 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k193658/ 2020-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k193658-viz-ich-fda-510k.jpg K193658 - Viz ICH K193658 is a FDA 510(k) cleared radiology medical device. Manufacturer: Viz. Ai, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k200094/ 2020-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k200094-spex-lp-support-catheter-fda-510k.jpg K200094 - speX LP Support Catheter K200094 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Reflow Medical. Cleared Mar 2020. https://www.510kdatabase.net/k200113/ 2020-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k200113-link-trabeculink-tibial-cones-fda-510k.jpg K200113 - LINK TrabecuLink Tibial Cones K200113 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Waldemar Link GmbH & Co. KG. Cleared Mar 2020. https://www.510kdatabase.net/k200198/ 2020-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k200198-wirion-fda-510k.jpg K200198 - WIRION K200198 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cardiovascular Systems, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k200406/ 2020-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k200406-evolve-breast-pump-fda-510k.jpg K200406 - Evolve Breast Pump K200406 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Hygeia II Medical Group, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k200418/ 2020-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k200418-vivix-s-vw-fda-510k.jpg K200418 - VIVIX-S VW K200418 is a FDA 510(k) cleared radiology medical device. Manufacturer: Vieworks Co., Ltd.. Cleared Mar 2020. https://www.510kdatabase.net/k191753/ 2020-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k191753-medline-sterile-powder-free-nitrile-fda-510k.jpg K191753 - Medline Sterile Powder-Free Nitrile Examination Gloves - Green (Tested For Use with Chemotherapy Drugs) K191753 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k192007/ 2020-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k192007-therabase-therabase-ca-fda-510k.jpg K192007 - TheraBase, TheraBase Ca K192007 is a FDA 510(k) cleared dental medical device. Manufacturer: Bisco, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k192272/ 2020-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k192272-wolf445nm-fda-510k.jpg K192272 - Wolf445nm K192272 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: A.R.C Laser GmbH. Cleared Mar 2020. https://www.510kdatabase.net/k192753/ 2020-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k192753-neuralscan-system-fda-510k.jpg K192753 - NeuralScan System K192753 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medeia, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k193310/ 2020-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k193310-mymerlin-mobile-application-android-fda-510k.jpg K193310 - myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) K193310 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott (St. Jude Medical). Cleared Mar 2020. https://www.510kdatabase.net/k193582/ 2020-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k193582-sterilcontainer-s2-system-fda-510k.jpg K193582 - SterilContainer S2 System K193582 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Aesculap, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k200136/ 2020-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k200136-shear-wave-quantificational-ultrasound-fda-510k.jpg K200136 - Shear Wave Quantificational Ultrasound Diagnostic System K200136 is a FDA 510(k) cleared radiology medical device. Manufacturer: Wuxi Hisky Medical Technologies Co., Ltd.. Cleared Mar 2020. https://www.510kdatabase.net/k200151/ 2020-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k200151-persona-partial-knee-tibial-cut-guide-fda-510k.jpg K200151 - Persona Partial Knee Tibial Cut Guide 5 Deg Left Medial Right Lateral, Persona Partial Knee Tibial Cut Guide 5 Deg Right Medial Left Lateral, Persona Partial Knee 2MM Tibial Recutter Left Medial Right Lateral, Persona Partial Knee 2MM Tibial Recutter Right Medial Left Lateral, Persona Partial Knee Tibial Drill K200151 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k200243/ 2020-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k200243-acuvue-senofilcon-a-soft-contact-lens-fda-510k.jpg K200243 - ACUVUE (senofilcon A) Soft Contact Lens Multifocal K200243 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Johnson & Johnson Vision Care, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k200433/ 2020-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k200433-ibalance-uka-tibial-tray-implant-fda-510k.jpg K200433 - iBalance UKA Tibial Tray Implant K200433 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k200443/ 2020-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k200443-endotool-iv-110-fda-510k.jpg K200443 - EndoTool IV 1.10 K200443 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Monarch Medical Technologies, LLC. Cleared Mar 2020. https://www.510kdatabase.net/k190495/ 2020-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k190495-transferrin-fda-510k.jpg K190495 - Transferrin K190495 is a FDA 510(k) cleared immunology medical device. Manufacturer: Biosystems S.A.. Cleared Mar 2020. https://www.510kdatabase.net/k190767/ 2020-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k190767-anatomicaligner-fda-510k.jpg K190767 - AnatomicAligner K190767 is a FDA 510(k) cleared dental medical device. Manufacturer: The Methodist Hospital Research Institute D/B/A Houston. Cleared Mar 2020. https://www.510kdatabase.net/k191705/ 2020-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k191705-optikview-gup2103cmi-fda-510k.jpg K191705 - OptikView GUP2103CMI K191705 is a FDA 510(k) cleared radiology medical device. Manufacturer: The Linden Group Corp. Cleared Mar 2020. https://www.510kdatabase.net/k191827/ 2020-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k191827-sunmed-disposable-angio-closure-pads-fda-510k.jpg K191827 - Sunmed Disposable Angio-Closure Pads K191827 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sunny Medical Device (Shenzhen) Co., Ltd.. Cleared Mar 2020. https://www.510kdatabase.net/k192713/ 2020-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k192713-altera-filter-and-hmefilter-fda-510k.jpg K192713 - Altera Filter and HME/Filter K192713 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Meditera Tibbi Malzeme San VE Tic AS. Cleared Mar 2020. https://www.510kdatabase.net/k193267/ 2020-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k193267-al-rad-companion-musculoskeletal-fda-510k.jpg K193267 - Al-Rad Companion (Musculoskeletal) K193267 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k193486/ 2020-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k193486-epic-980-fda-510k.jpg K193486 - Epic 980 K193486 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Biolase, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k200097/ 2020-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k200097-response-bandloc-spinal-fixation-fda-510k.jpg K200097 - Response BandLoc Spinal Fixation K200097 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OrthoPediatrics Corp.. Cleared Mar 2020. https://www.510kdatabase.net/k200110/ 2020-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k200110-sandro-dual-fda-510k.jpg K200110 - SANDRO Dual K200110 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wontech Co., Ltd.. Cleared Mar 2020. https://www.510kdatabase.net/k200385/ 2020-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k200385-continuum-pacs-fda-510k.jpg K200385 - CONTINUUM PACS K200385 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Integrated Ophthalmic Systems, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k200522/ 2020-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k200522-aero-chrome-breathable-performance-fda-510k.jpg K200522 - AERO CHROME* Breathable Performance Surgical Gowns K200522 is a FDA 510(k) cleared general hospital medical device. Manufacturer: O&M Halyard, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k190783/ 2020-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k190783-health-expert-electronic-stimulator-fda-510k.jpg K190783 - Health Expert Electronic Stimulator (model: AST-300L) K190783 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Osto Technology Company Limited. Cleared Mar 2020. https://www.510kdatabase.net/k191869/ 2020-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k191869-biogelr-pi-ultratouch-s-surgical-glove-fda-510k.jpg K191869 - Biogel(R) PI UltraTouch S Surgical Glove with a Low Dermatitis Potential Claim, Biogel(R) PI UltraTouch S Indicator Underglove with a Low Dermatitis Potential Claim K191869 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Molnlycke Health Care Us, LLC. Cleared Mar 2020. https://www.510kdatabase.net/k192162/ 2020-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k192162-neurovention-cranial-fixation-system-fda-510k.jpg K192162 - NeuroVention Cranial Fixation System, NuCrani Plates, KTC Burr Hole Cover, DC Plate K192162 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neurovention, LLC. Cleared Mar 2020. https://www.510kdatabase.net/k192241/ 2020-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k192241-halyard-purple-xtra-and-purple-sterile-fda-510k.jpg K192241 - Halyard Purple Xtra and Purple Sterile, Low Dermatitis Potential, Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate K192241 is a FDA 510(k) cleared general hospital medical device. Manufacturer: O&M Haylard, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k192483/ 2020-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k192483-mediostar-fda-510k.jpg K192483 - MeDioStar K192483 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Asclepion Laser Technologies GmbH. Cleared Mar 2020. https://www.510kdatabase.net/k192720/ 2020-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k192720-gia-stapler-with-tri-staple-technology-fda-510k.jpg K192720 - GIA Stapler with Tri-Staple Technology K192720 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien. Cleared Mar 2020. https://www.510kdatabase.net/k192817/ 2020-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k192817-curian-hpsa-curian-analyzer-fda-510k.jpg K192817 - Curian HpSA, Curian Analyzer K192817 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Meridian Bioscience, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k192888/ 2020-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k192888-ezortho-fda-510k.jpg K192888 - EzOrtho K192888 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ewoosoft Co., Ltd.. Cleared Mar 2020. https://www.510kdatabase.net/k192925/ 2020-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k192925-32hl512d-fda-510k.jpg K192925 - 32HL512D K192925 is a FDA 510(k) cleared radiology medical device. Manufacturer: Lg Electronics.Inc. Cleared Mar 2020. https://www.510kdatabase.net/k193105/ 2020-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k193105-iuni-unicondylar-knee-replacement-fda-510k.jpg K193105 - iUni Unicondylar Knee Replacement System, iDuo Bicompartmental Knee Repair System, iTotal CR Knee Replacement System, iTotal PS Knee Replacement System K193105 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Conformis, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k193110/ 2020-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k193110-3m-attest-vaporized-hydrogen-peroxide-fda-510k.jpg K193110 - 3M Attest Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E K193110 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Healthcare. Cleared Mar 2020. https://www.510kdatabase.net/k193244/ 2020-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k193244-indigo-aspiration-system-lightning-fda-510k.jpg K193244 - Indigo Aspiration System – Lightning Aspiration Tubing K193244 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Penumbra, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k193325/ 2020-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k193325-avantgarde-faecal-management-systems-fda-510k.jpg K193325 - Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches K193325 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Prosys International, Ltd.. Cleared Mar 2020. https://www.510kdatabase.net/k193418/ 2020-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k193418-seaspine-skipjack-system-fda-510k.jpg K193418 - SeaSpine Skipjack System K193418 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared Mar 2020. https://www.510kdatabase.net/k193482/ 2020-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k193482-prismax-system-version-3-fda-510k.jpg K193482 - PrisMax System Version 3 K193482 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corporation. Cleared Mar 2020. https://www.510kdatabase.net/k193572/ 2020-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k193572-vitek-2-ast-gram-negative-fda-510k.jpg K193572 - VITEK 2 AST-Gram Negative Imipenem/Relebactam (<=0.25/4 - >=16/4 µg/mL) K193572 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k200069/ 2020-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k200069-disposable-spo2-sensor-fda-510k.jpg K200069 - Disposable SpO2 Sensor K200069 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Changke Connect Electronics Co., Ltd.. Cleared Mar 2020. https://www.510kdatabase.net/k200075/ 2020-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k200075-3dmetal-diaphyseal-femoral-cones-fda-510k.jpg K200075 - 3DMetal Diaphyseal Femoral Cones K200075 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Mar 2020. https://www.510kdatabase.net/k200183/ 2020-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k200183-cs-9600-fda-510k.jpg K200183 - CS 9600 K200183 is a FDA 510(k) cleared radiology medical device. Manufacturer: Trophy. Cleared Mar 2020. https://www.510kdatabase.net/k200349/ 2020-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k200349-stat-profile-prime-plus-analyzer-system-fda-510k.jpg K200349 - Stat Profile Prime Plus Analyzer System K200349 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Nova Biomedical Corporation. Cleared Mar 2020. https://www.510kdatabase.net/k200358/ 2020-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k200358-fem-flex-ii-femoral-arterial-cannula-fda-510k.jpg K200358 - Fem-Flex II Femoral Arterial Cannula, Fem-Flex II Femoral Venous Cannula, Femoral Venous Cannula, FemTrak Femoral Venous Cannula K200358 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Mar 2020. https://www.510kdatabase.net/k200407/ 2020-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k200407-legion-inserts-with-jrny-lock-fda-510k.jpg K200407 - LEGION Inserts with JRNY Lock K200407 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k190978/ 2020-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k190978-reflexion-medical-radiotherapy-system-fda-510k.jpg K190978 - RefleXion Medical Radiotherapy System K190978 is a FDA 510(k) cleared radiology medical device. Manufacturer: Reflexion Medical, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k191638/ 2020-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k191638-pointe-scientific-cocaine-metabolite-fda-510k.jpg K191638 - Pointe Scientific Cocaine Metabolite Enzyme Immunoassay K191638 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Medtest DX. Cleared Mar 2020. https://www.510kdatabase.net/k191910/ 2020-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k191910-spacestation-mri-fda-510k.jpg K191910 - SpaceStation MRI K191910 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B. Braun Melsugen AG. Cleared Mar 2020. https://www.510kdatabase.net/k192338/ 2020-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k192338-neolab-clear-aligners-fda-510k.jpg K192338 - NEOLab Clear Aligners K192338 is a FDA 510(k) cleared dental medical device. Manufacturer: New England Ortho Lab, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k192388/ 2020-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k192388-sonovision-ultrasound-imaging-system-fda-510k.jpg K192388 - SonoVision Ultrasound Imaging System K192388 is a FDA 510(k) cleared radiology medical device. Manufacturer: Tissue Differentiation Intelligence, LLC. Cleared Mar 2020. https://www.510kdatabase.net/k193367/ 2020-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k193367-elysion-pro-fda-510k.jpg K193367 - elysion-pro K193367 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: High Technology Products S.L.U. Cleared Mar 2020. https://www.510kdatabase.net/k193448/ 2020-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k193448-bionourish-lubricant-fda-510k.jpg K193448 - BioNourish Lubricant K193448 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Good Clean Love, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k193468/ 2020-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k193468-tritium-sternal-cable-plate-system-fda-510k.jpg K193468 - Tritium Sternal Cable Plate System K193468 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.). Cleared Mar 2020. https://www.510kdatabase.net/k193538/ 2020-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k193538-sensititre-18-24-hour-mic-or-fda-510k.jpg K193538 - Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 µg/ml K193538 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Thermo Fisher Scientific. Cleared Mar 2020. https://www.510kdatabase.net/k193612/ 2020-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k193612-amt-suture-delivery-system-fda-510k.jpg K193612 - AMT Suture Delivery System K193612 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Applied Medical Technology, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k200263/ 2020-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k200263-health-line-ct-midline-catheter-fda-510k.jpg K200263 - Health Line CT Midline Catheter K200263 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Health Line International Corporation. Cleared Mar 2020. https://www.510kdatabase.net/k200341/ 2020-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k200341-arthrex-fibertak-suture-anchor-fda-510k.jpg K200341 - Arthrex FiberTak Suture Anchor K200341 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k190129/ 2020-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k190129-ac5-topical-gel-fda-510k.jpg K190129 - AC5 Topical Gel K190129 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Arch Therapeutics, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k192484/ 2020-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k192484-fixone-biocomposite-anchor-fda-510k.jpg K192484 - Fixone Biocomposite Anchor K192484 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aju Pharm Co., Ltd.. Cleared Mar 2020. https://www.510kdatabase.net/k192810/ 2020-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k192810-apollo-suture-anchor-system-fda-510k.jpg K192810 - Apollo Suture Anchor System K192810 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Valeris Medical. Cleared Mar 2020. https://www.510kdatabase.net/k192924/ 2020-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k192924-magnetom-vida-magnetom-lumina-magnetom-fda-510k.jpg K192924 - MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida Fit K192924 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k192979/ 2020-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k192979-kls-martin-individual-patient-fda-510k.jpg K192979 - KLS Martin Individual Patient Solutions (IPS) Planning System K192979 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: KLS-Martin L.P.. Cleared Mar 2020. https://www.510kdatabase.net/k193447/ 2020-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k193447-vista-dyes-fda-510k.jpg K193447 - Vista Dyes K193447 is a FDA 510(k) cleared dental medical device. Manufacturer: Inter-Med/Vista Dental Products. Cleared Mar 2020. https://www.510kdatabase.net/k200328/ 2020-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k200328-tesera-trabecular-technologies-t3-fda-510k.jpg K200328 - Tesera Trabecular Technologies (T3) Acetabular Shell System, Porous Acetabular Cup System K200328 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Kyocera Medical Technologies, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k200363/ 2020-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k200363-quidel-triage-tox-drug-screen-94600-fda-510k.jpg K200363 - Quidel Triage® TOX Drug Screen, 94600 K200363 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Quidel Cardiovascular, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k192328/ 2020-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k192328-jrmedik-latex-surgeons-gloves-powder-fda-510k.jpg K192328 - JR.MEDIK Latex Surgeon’s Gloves Powder Free K192328 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jr Engineering & Medical Technologies (M) Sdn. Bhd.. Cleared Mar 2020. https://www.510kdatabase.net/k193446/ 2020-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k193446-bare-808-fda-510k.jpg K193446 - Bare: 808 K193446 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Luvo Medical Technologies, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k193481/ 2020-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k193481-aeronox-20-nitric-oxide-titration-fda-510k.jpg K193481 - AeroNOx 2.0 Nitric Oxide Titration & Monitoring System K193481 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: International Biomedical. Cleared Mar 2020. https://www.510kdatabase.net/k200041/ 2020-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k200041-flexpointer-15-single-use-flextube-3-fda-510k.jpg K200041 - FlexPointer 1.5 Single Use, FlexTube 3 Single Use K200041 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Fiagon GmbH. Cleared Mar 2020. https://www.510kdatabase.net/k200331/ 2020-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k200331-rapid-acoustic-pulse-device-fda-510k.jpg K200331 - Rapid Acoustic Pulse Device K200331 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Soliton, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k200370/ 2020-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k200370-cdc-human-influenza-virus-real-time-rt-fda-510k.jpg K200370 - CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/H5 Subtyping Kit K200370 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Centers For Disease Control and Prevention. Cleared Mar 2020. https://www.510kdatabase.net/k183570/ 2020-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k183570-liquiband-plus-fda-510k.jpg K183570 - LiquiBand Plus K183570 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Advanced Medical Solutions Limited. Cleared Mar 2020. https://www.510kdatabase.net/k191624/ 2020-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k191624-fp-nivairo-rt047-vented-hospital-full-fda-510k.jpg K191624 - F&P Nivairo RT047 Vented Hospital Full Face Mask, Anti-Asphyxiation Valve Version K191624 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Fisher & Paykel Healthcare Limited. Cleared Mar 2020. https://www.510kdatabase.net/k192574/ 2020-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k192574-vantage-galan-3t-mrt-3020-v60-with-fda-510k.jpg K192574 - Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR K192574 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Mar 2020. https://www.510kdatabase.net/k192815/ 2020-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k192815-elecsys-brahms-pct-fda-510k.jpg K192815 - Elecsys BRAHMS PCT K192815 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Diagnostics. Cleared Mar 2020. https://www.510kdatabase.net/k193216/ 2020-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k193216-syngoct-lung-cad-fda-510k.jpg K193216 - syngo.CT Lung CAD K193216 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medi Cal Solutions, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k193262/ 2020-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k193262-dr-600-with-tomosynthesis-fda-510k.jpg K193262 - DR 600 with Tomosynthesis K193262 is a FDA 510(k) cleared radiology medical device. Manufacturer: Agfa N.V.. Cleared Mar 2020. https://www.510kdatabase.net/k193425/ 2020-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k193425-pre-milled-blank-fda-510k.jpg K193425 - Pre-Milled Blank K193425 is a FDA 510(k) cleared dental medical device. Manufacturer: Arum Dentistry Co., Ltd.. Cleared Mar 2020. https://www.510kdatabase.net/k193426/ 2020-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k193426-elite-iq-fda-510k.jpg K193426 - Elite iQ K193426 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cynosure, LLC. Cleared Mar 2020. https://www.510kdatabase.net/k200048/ 2020-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k200048-mectalif-anterior-simple-fda-510k.jpg K200048 - MectaLIF Anterior Simple K200048 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Mar 2020. https://www.510kdatabase.net/k200049/ 2020-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k200049-senhance-surgical-system-fda-510k.jpg K200049 - Senhance Surgical System K200049 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Transenterix, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k200258/ 2020-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k200258-edwards-esheath-introducer-set-fda-510k.jpg K200258 - Edwards eSheath Introducer Set K200258 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences. Cleared Mar 2020. https://www.510kdatabase.net/k190652/ 2020-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k190652-ossiofiber-hammertoe-fixation-fda-510k.jpg K190652 - OSSIOfiber™ Hammertoe Fixation System/OSSIOfiber™ Hammertoe Fixation Implant K190652 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OSSIO , Ltd.. Cleared Mar 2020. https://www.510kdatabase.net/k190918/ 2020-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k190918-swabtip-male-disinfectant-cap-fda-510k.jpg K190918 - SwabTip Male Disinfectant Cap K190918 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Icu Medical. Cleared Mar 2020. https://www.510kdatabase.net/k191031/ 2020-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k191031-nightowl-fda-510k.jpg K191031 - NightOwl K191031 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Ectosense NV. Cleared Mar 2020. https://www.510kdatabase.net/k191562/ 2020-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k191562-yumizen-c1200-ferritin-yumizen-c1200-fda-510k.jpg K191562 - Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor K191562 is a FDA 510(k) cleared immunology medical device. Manufacturer: HORIBA ABX SAS. Cleared Mar 2020. https://www.510kdatabase.net/k191566/ 2020-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k191566-avinent-surgical-tray-fda-510k.jpg K191566 - Avinent Surgical Tray K191566 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Avinent Implant System S.L.U.. Cleared Mar 2020. https://www.510kdatabase.net/k191568/ 2020-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k191568-sam-20-long-duration-ultrasound-system-fda-510k.jpg K191568 - sam 2.0 Long Duration Ultrasound System K191568 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: ZetrOZ Systems, LLC. Cleared Mar 2020. https://www.510kdatabase.net/k191583/ 2020-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k191583-photonblade-with-smoke-evacuation-fda-510k.jpg K191583 - PhotonBlade with Smoke Evacuation K191583 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Invuity, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k191655/ 2020-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k191655-megafix-pedicle-screw-spinal-system-fda-510k.jpg K191655 - MEGAFIX® Pedicle Screw Spinal System K191655 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Seohancare Co., Ltd.. Cleared Mar 2020. https://www.510kdatabase.net/k191915/ 2020-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k191915-sensicare-sterile-power-free-polymer-fda-510k.jpg K191915 - SensiCare Sterile Power-Free Polymer Coated Polyisoprene Sugical Glove, Coated with Aloe V K191915 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k192164/ 2020-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k192164-single-use-guide-sheath-kit-k-401-k-fda-510k.jpg K192164 - Single Use Guide Sheath Kit K-401, K-402, & Single Use Guiding Device CC-220DR K192164 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Mar 2020. https://www.510kdatabase.net/k192813/ 2020-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k192813-plasma-iq-fda-510k.jpg K192813 - Plasma IQ K192813 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Neauvia North America, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k193393/ 2020-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k193393-bond-ready-to-use-primary-antibody-fda-510k.jpg K193393 - BOND Ready-to-Use Primary Antibody Progesterone Receptor (16), Novocastra Liquid Mouse Monoclonal Antibody Progesterone Receptor Clone 16 (Concentrated Liquid Antibody Format). K193393 is a FDA 510(k) cleared pathology medical device. Manufacturer: Leica Biosystems Newcastle, Ltd.. Cleared Mar 2020. https://www.510kdatabase.net/k200267/ 2020-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k200267-lospa-is-spinal-fixation-system-fda-510k.jpg K200267 - LOSPA® IS™ Spinal Fixation System K200267 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corentec Co., Ltd.. Cleared Mar 2020. https://www.510kdatabase.net/k200304/ 2020-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k200304-epiq-diagnostic-ultrasound-system-fda-510k.jpg K200304 - EPIQ Diagnostic Ultrasound System K200304 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Ultrasound, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k200306/ 2020-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k200306-centrimag-circulatory-support-system-fda-510k.jpg K200306 - CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula Kit K200306 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott (Formerly Thoratec Corporation). Cleared Mar 2020. https://www.510kdatabase.net/k200310/ 2020-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k200310-1688-pendulum-4k-camera-head-with-fda-510k.jpg K200310 - 1688 Pendulum 4K Camera Head with Integrated Coupler, 1688 4K Camera Control Unit with Advanced Imaging Modality K200310 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker. Cleared Mar 2020. https://www.510kdatabase.net/k200311/ 2020-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k200311-versawrap-tendon-protector-fda-510k.jpg K200311 - VersaWrap Tendon Protector K200311 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Alafair Biosciences, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k200396/ 2020-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k200396-insight-enhanced-drf-digital-imaging-fda-510k.jpg K200396 - Insight Enhanced DRF Digital Imaging System K200396 is a FDA 510(k) cleared radiology medical device. Manufacturer: Imaging Engineering, LLC. Cleared Mar 2020. https://www.510kdatabase.net/k190527/ 2020-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k190527-glidepath-long-term-hemodialysis-fda-510k.jpg K190527 - GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters K190527 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C. R. Bard. Cleared Mar 2020. https://www.510kdatabase.net/k190993/ 2020-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k190993-kinepict-medical-imaging-tool-version-fda-510k.jpg K190993 - Kinepict Medical Imaging Tool version v2.2 K190993 is a FDA 510(k) cleared radiology medical device. Manufacturer: Kinepict Health, Ltd.. Cleared Mar 2020. https://www.510kdatabase.net/k191184/ 2020-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k191184-immuview-s-pneumoniae-and-l-fda-510k.jpg K191184 - ImmuView S pneumoniae and L pneumophila Urinary Antigen Test K191184 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Ssi Diagnostica A/S. Cleared Mar 2020. https://www.510kdatabase.net/k191709/ 2020-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k191709-v-strut-vertebral-implant-fda-510k.jpg K191709 - V-STRUT Vertebral Implant K191709 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Hyprevention Sas. Cleared Mar 2020. https://www.510kdatabase.net/k191991/ 2020-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k191991-ezfil-fda-510k.jpg K191991 - Ezfil K191991 is a FDA 510(k) cleared dental medical device. Manufacturer: Meta Biomed Co., Ltd.. Cleared Mar 2020. https://www.510kdatabase.net/k192590/ 2020-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k192590-cura-778-fda-510k.jpg K192590 - CURA 778 K192590 is a FDA 510(k) cleared radiology medical device. Manufacturer: Fmi Medical Systems, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k192697/ 2020-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k192697-instinct-plus-endoscopic-clipping-device-fda-510k.jpg K192697 - Instinct Plus Endoscopic Clipping Device K192697 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Endoscopy. Cleared Mar 2020. https://www.510kdatabase.net/k193072/ 2020-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k193072-lucent-ipl-fda-510k.jpg K193072 - Lucent : IPL K193072 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Luvo Medical Technologies, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k193101/ 2020-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k193101-omnifix-low-dead-space-luer-lock-syringe-fda-510k.jpg K193101 - Omnifix Low Dead Space Luer Lock Syringe K193101 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k193139/ 2020-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k193139-provecta-3d-prime-ceph-fda-510k.jpg K193139 - ProVecta 3D Prime Ceph K193139 is a FDA 510(k) cleared radiology medical device. Manufacturer: Durr Dental SE. Cleared Mar 2020. https://www.510kdatabase.net/k193147/ 2020-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k193147-stereotaxis-genesis-rmn-with-navigant-fda-510k.jpg K193147 - Stereotaxis Genesis RMN with Navigant Workstation (NWS) and Cardiodrive System K193147 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Stereotaxis, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k193229/ 2020-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k193229-transpara-fda-510k.jpg K193229 - Transpara K193229 is a FDA 510(k) cleared radiology medical device. Manufacturer: Screenpoint Medical B.V.. Cleared Mar 2020. https://www.510kdatabase.net/k193402/ 2020-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k193402-allthread-peek-suture-anchor-fda-510k.jpg K193402 - ALLthread PEEK Suture Anchor K193402 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k193529/ 2020-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k193529-atlantis-abutment-for-mis-conical-fda-510k.jpg K193529 - ATLANTIS Abutment for MIS Conical Connection Implants K193529 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona. Cleared Mar 2020. https://www.510kdatabase.net/k200360/ 2020-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k200360-trackx-fda-510k.jpg K200360 - TrackX K200360 is a FDA 510(k) cleared radiology medical device. Manufacturer: Track X Technology, LLC. Cleared Mar 2020. https://www.510kdatabase.net/k190509/ 2020-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k190509-lubrina-2-fda-510k.jpg K190509 - Lubrina 2 K190509 is a FDA 510(k) cleared dental medical device. Manufacturer: J. Morita USA, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k191525/ 2020-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k191525-kinematx-total-wrist-arthroplasty-system-fda-510k.jpg K191525 - KinematX Total Wrist Arthroplasty System K191525 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Extremity Medical, LLC. Cleared Mar 2020. https://www.510kdatabase.net/k191550/ 2020-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k191550-broncholab-fda-510k.jpg K191550 - Broncholab K191550 is a FDA 510(k) cleared radiology medical device. Manufacturer: Fluidda, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k192906/ 2020-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k192906-mecta-c-stand-alone-fda-510k.jpg K192906 - Mecta-C Stand Alone K192906 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Mar 2020. https://www.510kdatabase.net/k193019/ 2020-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k193019-dannik-disposable-monopolar-fda-510k.jpg K193019 - DANNIK Disposable Monopolar Laparoscopic Instrument K193019 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Dannik. Cleared Mar 2020. https://www.510kdatabase.net/k193374/ 2020-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k193374-tumease-acupressure-bracelets-fda-510k.jpg K193374 - TumEase Acupressure Bracelets K193374 is a FDA 510(k) cleared neurology medical device. Manufacturer: Mumease. Cleared Mar 2020. https://www.510kdatabase.net/k193389/ 2020-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k193389-vista-clear-fda-510k.jpg K193389 - Vista Clear K193389 is a FDA 510(k) cleared dental medical device. Manufacturer: Inter-Med/Vista Dental Products. Cleared Mar 2020. https://www.510kdatabase.net/k193616/ 2020-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k193616-arix-ankle-system-fda-510k.jpg K193616 - ARIX Ankle System K193616 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Jeil Medical Corporation. Cleared Mar 2020. https://www.510kdatabase.net/k200028/ 2020-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k200028-coronet-soft-tissue-fixation-system-fda-510k.jpg K200028 - Coronet Soft Tissue Fixation System K200028 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Conextions Medical. Cleared Mar 2020. https://www.510kdatabase.net/k200262/ 2020-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k200262-l100-go-system-fda-510k.jpg K200262 - L100 Go System K200262 is a FDA 510(k) cleared neurology medical device. Manufacturer: Bioness, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k200269/ 2020-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k200269-sapphire-ii-pro-fda-510k.jpg K200269 - Sapphire II PRO K200269 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Orbusneich Medical Trading, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k200314/ 2020-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k200314-capere-thrombectomy-system-fda-510k.jpg K200314 - Capere Thrombectomy System K200314 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vascular Medcure, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k192032/ 2020-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k192032-fixone-biocomposite-small-anchor-fda-510k.jpg K192032 - Fixone Biocomposite Small Anchor K192032 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aju Pharm Co., Ltd.. Cleared Mar 2020. https://www.510kdatabase.net/k193064/ 2020-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k193064-atlantis-suprastructures-fda-510k.jpg K193064 - Atlantis suprastructures K193064 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k193358/ 2020-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k193358-microscan-dried-gram-negative-miccombo-fda-510k.jpg K193358 - MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16ug/mL) K193358 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k200275/ 2020-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k200275-ovision-imaging-system-fda-510k.jpg K200275 - OVision Imaging System K200275 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Ophthalmic Labs, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k183425/ 2020-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k183425-cardiovit-at-102-g2-fda-510k.jpg K183425 - CARDIOVIT AT-102 G2 K183425 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Schiller AG. Cleared Mar 2020. https://www.510kdatabase.net/k191872/ 2020-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k191872-menicon-3-hydrogen-peroxide-cleaning-fda-510k.jpg K191872 - Menicon 3% Hydrogen Peroxide Cleaning and Disinfecting Solution K191872 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Menicon Co, Ltd.. Cleared Mar 2020. https://www.510kdatabase.net/k192506/ 2020-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k192506-vantage-galan-3t-mrt-3020-v60-fda-510k.jpg K192506 - Vantage Galan 3T, MRT-3020, V6.0 K192506 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Mar 2020. https://www.510kdatabase.net/k192637/ 2020-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k192637-high-strength-suture-fda-510k.jpg K192637 - High Strength Suture K192637 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Yunyi (Beijing) Medical Device Co., Ltd.. Cleared Mar 2020. https://www.510kdatabase.net/k193256/ 2020-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k193256-anjon-bremer-halo-system-fda-510k.jpg K193256 - Anjon Bremer Halo System K193256 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Anjon Holdings, LLC. Cleared Mar 2020. https://www.510kdatabase.net/k193356/ 2020-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k193356-bizact-tonsillectomy-device-advanced-fda-510k.jpg K193356 - BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider K193356 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Covidien, LLC. Cleared Mar 2020. https://www.510kdatabase.net/k193378/ 2020-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k193378-carboclear-lumbar-cage-system-fda-510k.jpg K193378 - CarboClear Lumbar Cage System K193378 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: CarboFix Orthopedics , Ltd.. Cleared Mar 2020. https://www.510kdatabase.net/k193532/ 2020-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k193532-liaison-anti-hav-assay-fda-510k.jpg K193532 - LIAISON Anti-HAV Assay K193532 is a FDA 510(k) cleared microbiology medical device. Manufacturer: DiaSorin, Inc.. Cleared Mar 2020. https://www.510kdatabase.net/k190304/ 2020-02-29 monthly 0.5 https://www.510kdatabase.net/og-image/k190304-kingon-p2-oxygen-concentrator-fda-510k.jpg K190304 - Kingon P2 Oxygen Concentrator K190304 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Qingdao Kingon Medical Science and Technology Co.. Cleared Feb 2020. https://www.510kdatabase.net/k183680/ 2020-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k183680-i-stat-chem8-cartridge-with-the-i-stat-fda-510k.jpg K183680 - i-STAT CHEM8+ cartridge with the i-STAT 1 System K183680 is a FDA 510(k) cleared hematology medical device. Manufacturer: Abbott Point of Care, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k191246/ 2020-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k191246-paragon-adult-maxi-pmp-oxygenator-fda-510k.jpg K191246 - Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP) K191246 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Chalice Medical , Ltd.. Cleared Feb 2020. https://www.510kdatabase.net/k191555/ 2020-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k191555-harmonic-hd-1000i-shears-20-cm-length-fda-510k.jpg K191555 - HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length K191555 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon Endo-Surgery, LLC. Cleared Feb 2020. https://www.510kdatabase.net/k191556/ 2020-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k191556-red-dot-fda-510k.jpg K191556 - Red Dot K191556 is a FDA 510(k) cleared radiology medical device. Manufacturer: Behold.Ai Technologies Limited. Cleared Feb 2020. https://www.510kdatabase.net/k191928/ 2020-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k191928-accucontour-fda-510k.jpg K191928 - AccuContour K191928 is a FDA 510(k) cleared radiology medical device. Manufacturer: Xiamen Manteia Technology , Ltd.. Cleared Feb 2020. https://www.510kdatabase.net/k192247/ 2020-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k192247-steripath-gen2-blood-collection-system-fda-510k.jpg K192247 - Steripath Gen2 Blood Collection System K192247 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Magnolia Medical Technologies, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k192346/ 2020-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k192346-scaffolene-cl100-bioresorbable-fda-510k.jpg K192346 - scaffolene CL100 Bioresorbable Collagen Matrix K192346 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Freudenberg Technology Innovation SE & Co. KG. Cleared Feb 2020. https://www.510kdatabase.net/k192447/ 2020-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k192447-superelastic-staple-fda-510k.jpg K192447 - Superelastic Staple K192447 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Neosteo. Cleared Feb 2020. https://www.510kdatabase.net/k192496/ 2020-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k192496-magnetom-sola-magnetom-altea-and-fda-510k.jpg K192496 - Magnetom Sola, Magnetom Altea and Magnetom Sola Fit K192496 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k192570/ 2020-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k192570-atlas-spine-expandable-cervical-fda-510k.jpg K192570 - Atlas Spine Expandable Cervical Standalone Interbody System K192570 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Atlas Spine, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k192660/ 2020-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k192660-zimmer-ml-taper-hip-prosthesis-fda-510k.jpg K192660 - Zimmer M/L Taper Hip Prosthesis K192660 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k192820/ 2020-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k192820-sensicare-neoprene-synthetic-fda-510k.jpg K192820 - SensiCare Neoprene Synthetic Polychloroprene Surgical Glove (Tested for Use with Chemotherapy Drugs) K192820 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k192962/ 2020-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k192962-icobrain-ctp-fda-510k.jpg K192962 - icobrain-ctp K192962 is a FDA 510(k) cleared radiology medical device. Manufacturer: Icometrix NV. Cleared Feb 2020. https://www.510kdatabase.net/k193029/ 2020-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k193029-conquest-fn-fda-510k.jpg K193029 - CONQUEST FN K193029 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k193243/ 2020-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k193243-alta-multipurpose-device-fda-510k.jpg K193243 - Alta Multipurpose Device K193243 is a FDA 510(k) cleared radiology medical device. Manufacturer: Qfix. Cleared Feb 2020. https://www.510kdatabase.net/k193416/ 2020-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k193416-cellvizio-ive-with-confocal-miniprobes-fda-510k.jpg K193416 - Cellvizio I.V.E. with Confocal Miniprobes K193416 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Mauna Kea Technologies. Cleared Feb 2020. https://www.510kdatabase.net/k193483/ 2020-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k193483-basal-iq-technology-fda-510k.jpg K193483 - Basal-IQ Technology K193483 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Tandem Diabetes Care, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k193550/ 2020-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k193550-therm-x-fda-510k.jpg K193550 - Therm-X K193550 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zenith Technical Innovations. Cleared Feb 2020. https://www.510kdatabase.net/k200221/ 2020-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k200221-ct-fsd-compatible-applicators-fletcher-fda-510k.jpg K200221 - CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators (Henschke), HDR CT Compatible Split Ring Applicator, Segmented Vaginal Applicator, HDR Miami Applicator HDR Brachytherapy Applicator, 2/3 Endometrial Applicator Sets, CT HDR Ring & Tandem Applicator with Rectal Retractor K200221 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mick Radio-Nuclear Instruments, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k200225/ 2020-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k200225-arctic-sun-stat-temperature-management-fda-510k.jpg K200225 - Arctic Sun Stat Temperature Management System K200225 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medivance, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k200284/ 2020-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k200284-r-sensor-r-sensor-fda-510k.jpg K200284 - R-Sensor, R-Sensor K200284 is a FDA 510(k) cleared radiology medical device. Manufacturer: Remedi Co., Ltd.. Cleared Feb 2020. https://www.510kdatabase.net/k200381/ 2020-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k200381-daytona-small-stature-spinal-system-fda-510k.jpg K200381 - Daytona® Small Stature Spinal System K200381 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared Feb 2020. https://www.510kdatabase.net/k190032/ 2020-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k190032-disposable-sclerotherapy-needle-fda-510k.jpg K190032 - Disposable Sclerotherapy Needle K190032 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hangzhou AGS MedTech Co., Ltd.. Cleared Feb 2020. https://www.510kdatabase.net/k190682/ 2020-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k190682-explorer-mini-fda-510k.jpg K190682 - Explorer Mini K190682 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Permobil AB. Cleared Feb 2020. https://www.510kdatabase.net/k190919/ 2020-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k190919-st-internal-implant-system-fda-510k.jpg K190919 - ST Internal Implant System K190919 is a FDA 510(k) cleared dental medical device. Manufacturer: T-Plus Implant Tech. Co., Ltd.. Cleared Feb 2020. https://www.510kdatabase.net/k191462/ 2020-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k191462-proov-test-fda-510k.jpg K191462 - Proov Test K191462 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Mfb Fertility, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k191946/ 2020-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k191946-penumbra-system-penumbra-jet-7x-fda-510k.jpg K191946 - Penumbra System Penumbra JET 7X K191946 is a FDA 510(k) cleared neurology medical device. Manufacturer: Penumbra, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k192096/ 2020-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k192096-omnia-medical-trauma-screws-fda-510k.jpg K192096 - Omnia Medical Trauma Screws K192096 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Omnia Medical, LLC. Cleared Feb 2020. https://www.510kdatabase.net/k192305/ 2020-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k192305-colibri-endoscopy-system-fda-510k.jpg K192305 - Colibri Endoscopy System K192305 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: 3nt Medical , Ltd.. Cleared Feb 2020. https://www.510kdatabase.net/k192619/ 2020-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k192619-pitkar-locked-plating-system-fda-510k.jpg K192619 - Pitkar Locked Plating System K192619 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: S.H.Pitkar Orthotools Pvt. , Ltd.. Cleared Feb 2020. https://www.510kdatabase.net/k192683/ 2020-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k192683-biolox-delta-ceramic-heads-biolox-fda-510k.jpg K192683 - Biolox delta Ceramic Heads, Biolox delta Option Ceramic Heads K192683 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet UK, Ltd.. Cleared Feb 2020. https://www.510kdatabase.net/k192804/ 2020-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k192804-cerebase-da-guide-sheath-95cm-cerebase-fda-510k.jpg K192804 - CEREBASE DA Guide Sheath, 95cm, CEREBASE DA Guide Sheath, 90cm, CEREBASE DA Guide Sheath, 80cm, CEREBASE DA Guide Sheath, 70cm K192804 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medos International SARL. Cleared Feb 2020. https://www.510kdatabase.net/k192876/ 2020-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k192876-intellio-tablet-application-fda-510k.jpg K192876 - INTELLIO Tablet Application K192876 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew. Cleared Feb 2020. https://www.510kdatabase.net/k193242/ 2020-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k193242-masimo-rad-97-pulse-co-oximeter-and-fda-510k.jpg K193242 - Masimo Rad-97 Pulse CO-Oximeter and Accessories, Masimo Radical-7 Pulse CO-Oximeter and Accessories, Masimo Radius-7 Pulse CO-Oximeter and Accessories K193242 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Masimo Corporation. Cleared Feb 2020. https://www.510kdatabase.net/k193268/ 2020-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k193268-apriocore-plus-fda-510k.jpg K193268 - APrioCore Plus K193268 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Apriomed AB. Cleared Feb 2020. https://www.510kdatabase.net/k193274/ 2020-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k193274-rodo-abutment-system-fda-510k.jpg K193274 - Rodo Abutment System K193274 is a FDA 510(k) cleared dental medical device. Manufacturer: Rodo Medical, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k193313/ 2020-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k193313-elecsys-anti-tshr-fda-510k.jpg K193313 - Elecsys Anti-TSHR K193313 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics. Cleared Feb 2020. https://www.510kdatabase.net/k200206/ 2020-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k200206-axs-vecta-71-intermediate-catheter-axs-fda-510k.jpg K200206 - AXS Vecta 71 Intermediate Catheter, AXS Vecta 74 Intermediate Catheter K200206 is a FDA 510(k) cleared neurology medical device. Manufacturer: Stryker Neurovascular. Cleared Feb 2020. https://www.510kdatabase.net/k200247/ 2020-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k200247-fusion-quattro-extraction-balloon-fda-510k.jpg K200247 - Fusion Quattro Extraction Balloon K200247 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Wilson-Cook Medical, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k191463/ 2020-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k191463-depuy-synthes-hammertoe-continuous-fda-510k.jpg K191463 - DePuy Synthes Hammertoe Continuous Compression Implant K191463 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes USA Products, LLC. Cleared Feb 2020. https://www.510kdatabase.net/k192192/ 2020-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k192192-vsp-system-fda-510k.jpg K192192 - VSP System K192192 is a FDA 510(k) cleared dental medical device. Manufacturer: 3D Systems. Cleared Feb 2020. https://www.510kdatabase.net/k193506/ 2020-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k193506-nuvasive-x-core-expandable-vbr-system-fda-510k.jpg K193506 - NuVasive X-Core Expandable VBR System, NuVasive X-Core Mini Cervical Expandable VBR System K193506 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Feb 2020. https://www.510kdatabase.net/k200189/ 2020-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k200189-luna-dental-implant-system-healing-fda-510k.jpg K200189 - Luna Dental Implant System- Healing Abutment K200189 is a FDA 510(k) cleared dental medical device. Manufacturer: Shinhung Mst Co., Ltd.. Cleared Feb 2020. https://www.510kdatabase.net/k200197/ 2020-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k200197-ark-fentanyl-ii-assay-fda-510k.jpg K200197 - ARK Fentanyl II Assay K200197 is a FDA 510(k) cleared toxicology medical device. Manufacturer: ARK Diagnostics, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k191389/ 2020-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k191389-allcem-veneer-aps-fda-510k.jpg K191389 - Allcem Veneer APS K191389 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentscare Ltda. Cleared Feb 2020. https://www.510kdatabase.net/k191402/ 2020-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k191402-heater-cooler-system-3t-fda-510k.jpg K191402 - Heater-Cooler System 3T K191402 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Livanova Deutschland, GmbH. Cleared Feb 2020. https://www.510kdatabase.net/k192253/ 2020-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k192253-soniceye-dual-array-ultrasound-system-fda-510k.jpg K192253 - SonicEye Dual-Array Ultrasound System K192253 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sonivate Medical, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k192898/ 2020-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k192898-pneumoliner-fda-510k.jpg K192898 - PneumoLiner K192898 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Advanced Surgical Concepts. Cleared Feb 2020. https://www.510kdatabase.net/k193414/ 2020-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k193414-trigon-ha-stand-alone-wedge-fixation-fda-510k.jpg K193414 - Trigon HA Stand-Alone Wedge Fixation System K193414 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nvision Biomedical Technologies, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k200016/ 2020-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k200016-uct-530-uct-550-fda-510k.jpg K200016 - uCT 530, uCT 550 K200016 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Feb 2020. https://www.510kdatabase.net/k200178/ 2020-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k200178-ez3d-i-e3-fda-510k.jpg K200178 - Ez3D-i /E3 K200178 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ewoosoft Co., Ltd.. Cleared Feb 2020. https://www.510kdatabase.net/k200234/ 2020-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k200234-surgical-laser-fibers-fda-510k.jpg K200234 - Surgical laser fibers K200234 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Quanta System Spa. Cleared Feb 2020. https://www.510kdatabase.net/k200236/ 2020-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k200236-vitros-brahms-pct-reagent-pack-and-fda-510k.jpg K200236 - VITROS BRAHMS PCT Reagent Pack and Calibrators K200236 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Ortho-Clinical Diagnostics. Cleared Feb 2020. https://www.510kdatabase.net/den190020/ 2020-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/den190020-itind-system-fda-510k.jpg DEN190020 - iTind System DEN190020 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medi-Tate , Ltd.. Cleared Feb 2020. https://www.510kdatabase.net/k191474/ 2020-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k191474-naturalyte-dry-bicarbonate-concentrate-fda-510k.jpg K191474 - NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry Bicarbonate Concentrate (Carton) K191474 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC. Cleared Feb 2020. https://www.510kdatabase.net/k191858/ 2020-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k191858-pylant-monitor-fda-510k.jpg K191858 - Pylant Monitor K191858 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Kal-Med, LLC. Cleared Feb 2020. https://www.510kdatabase.net/k192756/ 2020-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k192756-aquadex-flexflow-system-20-fda-510k.jpg K192756 - Aquadex FlexFlow System 2.0 K192756 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Chf Solutions, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k192855/ 2020-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k192855-delta-xtendtm-reverse-shoulder-system-fda-510k.jpg K192855 - DELTA XTEND(TM) Reverse Shoulder System K192855 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy(Ireland). Cleared Feb 2020. https://www.510kdatabase.net/k193180/ 2020-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k193180-alliance-augmented-glenoid-fda-510k.jpg K193180 - Alliance Augmented Glenoid K193180 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k193412/ 2020-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k193412-nexxt-matrixx-system-fda-510k.jpg K193412 - NEXXT MATRIXX System K193412 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nexxt Spine, LLC. Cleared Feb 2020. https://www.510kdatabase.net/k193451/ 2020-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k193451-titanium-interference-screws-fda-510k.jpg K193451 - Titanium Interference Screws K193451 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k200214/ 2020-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k200214-3d-predict-fda-510k.jpg K200214 - 3D Predict K200214 is a FDA 510(k) cleared dental medical device. Manufacturer: 3D Smile USA, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k193308/ 2020-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k193308-t2-alpha-tibia-nailing-system-imn-fda-510k.jpg K193308 - T2 Alpha Tibia Nailing System, IMN Screws System K193308 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Trauma GmbH. Cleared Feb 2020. https://www.510kdatabase.net/k190363/ 2020-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k190363-omnia-medical-tibrid-cervical-cage-fda-510k.jpg K190363 - Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Medical TiBrid ALIF Cage, Omnia Medical TiBrid PLIF Cage, Omnia Medical TiBrid TLIF Cage K190363 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Omnia Medical, LLC. Cleared Feb 2020. https://www.510kdatabase.net/k190641/ 2020-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k190641-arn-sla-type-implant-system-fda-510k.jpg K190641 - AR_N SLA Type Implant System K190641 is a FDA 510(k) cleared dental medical device. Manufacturer: Biotem Co., Ltd.. Cleared Feb 2020. https://www.510kdatabase.net/k191030/ 2020-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k191030-applied-biosystems-3500-dx-genetic-fda-510k.jpg K191030 - Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic Analyzer K191030 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Life Technologies Corporation. Cleared Feb 2020. https://www.510kdatabase.net/k191313/ 2020-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k191313-unity-subcutaneous-infusion-system-for-fda-510k.jpg K191313 - Unity Subcutaneous Infusion System for Remodulin K191313 is a FDA 510(k) cleared general hospital medical device. Manufacturer: DEKA Research & Development. Cleared Feb 2020. https://www.510kdatabase.net/k191407/ 2020-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k191407-novalung-system-fda-510k.jpg K191407 - Novalung System K191407 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC. Cleared Feb 2020. https://www.510kdatabase.net/k191536/ 2020-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k191536-biatain-silicone-ag-fda-510k.jpg K191536 - Biatain Silicone Ag K191536 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Coloplast A/S. Cleared Feb 2020. https://www.510kdatabase.net/k191646/ 2020-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k191646-beamscan-mr-fda-510k.jpg K191646 - Beamscan MR K191646 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ptw-Freiburg Physikalisch-Technische-Werkstaetten. Cleared Feb 2020. https://www.510kdatabase.net/k191697/ 2020-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k191697-cardiac-monitor-1500-fda-510k.jpg K191697 - Cardiac Monitor 1500 K191697 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Zynex Medical, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k191728/ 2020-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k191728-ultepap-expiratory-positive-airway-fda-510k.jpg K191728 - ULTepap Expiratory Positive Airway Pressure (EPAP) Device K191728 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Bryggs Medical, LLC. Cleared Feb 2020. https://www.510kdatabase.net/k191740/ 2020-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k191740-doro-lucent-ixi-and-imri-headrest-system-fda-510k.jpg K191740 - DORO LUCENT® iXI and iMRI Headrest System K191740 is a FDA 510(k) cleared neurology medical device. Manufacturer: Pro-Med Instruments GmbH. Cleared Feb 2020. https://www.510kdatabase.net/k191894/ 2020-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k191894-upper-arm-blood-pressure-monitor-fda-510k.jpg K191894 - Upper Arm Blood Pressure Monitor K191894 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Zhengkang Technology Co., Ltd.. Cleared Feb 2020. https://www.510kdatabase.net/k192072/ 2020-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k192072-tina-quant-c-reactive-protein-iv-fda-510k.jpg K192072 - Tina-quant C-Reactive Protein IV K192072 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics Operations (Rdo). Cleared Feb 2020. https://www.510kdatabase.net/k192263/ 2020-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k192263-ucla-ccm-abutment-fda-510k.jpg K192263 - UCLA CCM Abutment K192263 is a FDA 510(k) cleared dental medical device. Manufacturer: Dio Corporation. Cleared Feb 2020. https://www.510kdatabase.net/k192491/ 2020-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k192491-coolief-radiofrequency-generator-crg-fda-510k.jpg K192491 - Coolief Radiofrequency Generator (CRG) System K192491 is a FDA 510(k) cleared neurology medical device. Manufacturer: Avanos Medical, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k192600/ 2020-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k192600-cyber-ho-60-cyber-ho-100-litho-100-fda-510k.jpg K192600 - Cyber Ho 60, Cyber Ho 100, Litho 100, Litho 60 K192600 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Quanta System Spa. Cleared Feb 2020. https://www.510kdatabase.net/k192691/ 2020-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k192691-patcom-single-use-introducer-fda-510k.jpg K192691 - PatCom Single-Use Introducer K192691 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: H&A Mui Enterprises, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k192799/ 2020-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k192799-glenoid-baseplate-with-screw-fda-510k.jpg K192799 - Glenoid Baseplate with Screw K192799 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Fx Shoulder USA, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k192832/ 2020-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k192832-aquilion-prime-sp-tsx-303b8-v102-with-fda-510k.jpg K192832 - Aquilion Prime SP (TSX-303B8) V10.2 with AiCE-i K192832 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Feb 2020. https://www.510kdatabase.net/k192851/ 2020-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k192851-oasis-mri-system-fda-510k.jpg K192851 - OASIS MRI System K192851 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hitachi Healthcare Americas. Cleared Feb 2020. https://www.510kdatabase.net/k193118/ 2020-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k193118-tgs-guidewire-and-updated-scopis-fda-510k.jpg K193118 - TGS Guidewire and updated Scopis Software K193118 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Stryker Ent. Cleared Feb 2020. https://www.510kdatabase.net/k200148/ 2020-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k200148-lightforce-orthodontic-system-lfo-system-fda-510k.jpg K200148 - LightForce Orthodontic System (LFO System) K200148 is a FDA 510(k) cleared dental medical device. Manufacturer: Lightforce Orthodontics. Cleared Feb 2020. https://www.510kdatabase.net/k200161/ 2020-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k200161-3mp-monochrome-digital-mammography-lcd-fda-510k.jpg K200161 - 3MP Monochrome Digital Mammography LCD Monitor MS-S300 K200161 is a FDA 510(k) cleared radiology medical device. Manufacturer: Jvckenwood Corporation. Cleared Feb 2020. https://www.510kdatabase.net/k200184/ 2020-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k200184-smoothskin-pure-fda-510k.jpg K200184 - SmoothSkin Pure K200184 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cyden Limited. Cleared Feb 2020. https://www.510kdatabase.net/den190023/ 2020-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/den190023-amplidex-fragile-x-dx-carrier-screen-kit-fda-510k.jpg DEN190023 - AmplideX Fragile X Dx & Carrier Screen Kit DEN190023 is a FDA 510(k) cleared medical genetics medical device. Manufacturer: Asuragen, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k190406/ 2020-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k190406-sds22-dental-implant-fda-510k.jpg K190406 - SDS2.2 dental implant K190406 is a FDA 510(k) cleared dental medical device. Manufacturer: Sds Swiss Dental Solutions AG. Cleared Feb 2020. https://www.510kdatabase.net/k190806/ 2020-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k190806-flowart-fda-510k.jpg K190806 - Flowart K190806 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Asset Medikal Tasarim As.. Cleared Feb 2020. https://www.510kdatabase.net/k191719/ 2020-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k191719-x-mind-trium-fda-510k.jpg K191719 - X-MIND Trium K191719 is a FDA 510(k) cleared radiology medical device. Manufacturer: De Gotzen S.R.L.. Cleared Feb 2020. https://www.510kdatabase.net/k192545/ 2020-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k192545-potenza-fda-510k.jpg K192545 - Potenza K192545 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Jeisys Medical Incorporated. Cleared Feb 2020. https://www.510kdatabase.net/k192617/ 2020-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k192617-gemini-810980-soft-tissue-laser-fda-510k.jpg K192617 - Gemini 810+980 Soft Tissue Laser K192617 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Azena Medical, LLC. Cleared Feb 2020. https://www.510kdatabase.net/k192624/ 2020-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k192624-apneatrak-fda-510k.jpg K192624 - ApneaTrak K192624 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cadwell Industries, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k192918/ 2020-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k192918-video-laparoscope-video-processor-fda-510k.jpg K192918 - Video Laparoscope, Video Processor, Light Source K192918 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Fujifilm Corporation. Cleared Feb 2020. https://www.510kdatabase.net/k192922/ 2020-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k192922-gentuity-hf-oct-imaging-system-with-fda-510k.jpg K192922 - Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter K192922 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Gentuity, LLC. Cleared Feb 2020. https://www.510kdatabase.net/k193015/ 2020-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k193015-hydropicc-picc-142-fda-510k.jpg K193015 - HydroPICC (PICC-142) K193015 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Access Vascular, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k193098/ 2020-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k193098-exactech-equinoxe-reverse-shoulder-fda-510k.jpg K193098 - Exactech® Equinoxe® Reverse Shoulder Glenospheres K193098 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k193255/ 2020-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k193255-largo-peek-interbody-system-fda-510k.jpg K193255 - Largo PEEK Interbody System K193255 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Flospine, LLC. Cleared Feb 2020. https://www.510kdatabase.net/k193303/ 2020-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k193303-tinnitus-sound-generator-module-fda-510k.jpg K193303 - Tinnitus Sound Generator Module K193303 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: GN Hearing A/S. Cleared Feb 2020. https://www.510kdatabase.net/k193533/ 2020-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k193533-win-flexible-nail-system-fda-510k.jpg K193533 - WIN Flexible Nail System K193533 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k193596/ 2020-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k193596-wingman-14-wingman-14c-wingman-18-fda-510k.jpg K193596 - Wingman 14, Wingman 14C, Wingman 18, Wingman 35 K193596 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Reflow Medical. Cleared Feb 2020. https://www.510kdatabase.net/k192000/ 2020-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k192000-d-r-burton-oxypap-fda-510k.jpg K192000 - D R Burton OxyPAP K192000 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: D R Burton Healthcare, LLC. Cleared Feb 2020. https://www.510kdatabase.net/k192460/ 2020-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k192460-sentinel-cerebral-protection-system-fda-510k.jpg K192460 - Sentinel Cerebral Protection System K192460 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Feb 2020. https://www.510kdatabase.net/k192973/ 2020-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k192973-densitas-densityai-fda-510k.jpg K192973 - densitas densityai K192973 is a FDA 510(k) cleared radiology medical device. Manufacturer: Densitas, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k193012/ 2020-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k193012-spex-support-catheter-fda-510k.jpg K193012 - speX Support Catheter K193012 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Reflow Medical. Cleared Feb 2020. https://www.510kdatabase.net/k193209/ 2020-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k193209-wego-stainless-steel-fda-510k.jpg K193209 - Wego-Stainless Steel K193209 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Foosin Medical Supplies Inc., Ltd.. Cleared Feb 2020. https://www.510kdatabase.net/k200228/ 2020-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k200228-clearcam-system-fda-510k.jpg K200228 - ClearCam System K200228 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Clearcam, LLC. Cleared Feb 2020. https://www.510kdatabase.net/k190487/ 2020-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k190487-inpen-dose-calculator-fda-510k.jpg K190487 - InPen Dose Calculator K190487 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Companion Medical, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k191514/ 2020-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k191514-carestart-flu-ab-plus-fda-510k.jpg K191514 - CareStart Flu A&B Plus K191514 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Access Bio, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k192381/ 2020-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k192381-dfv-desensitizing-varnish-strawberry-fda-510k.jpg K192381 - DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing Varnish-Bubblegum (Tutti-Fruity) Flavor, DFV Desensitizing Varnish-Spearmint Flavor, DFV Desensitizing Varnish-Chocolate Flavor, DFV Desensitizing Varnish-Marshmallow Flavor K192381 is a FDA 510(k) cleared dental medical device. Manufacturer: Scientific Pharmaceuticals. Cleared Feb 2020. https://www.510kdatabase.net/k192674/ 2020-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k192674-mixing-and-delivery-system-fda-510k.jpg K192674 - Mixing and Delivery System K192674 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bone Solutions, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k192677/ 2020-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k192677-safety-insulin-pen-needle-fda-510k.jpg K192677 - Safety Insulin Pen Needle K192677 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Caina Medical Co.,Ltd. Cleared Feb 2020. https://www.510kdatabase.net/k192894/ 2020-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k192894-vita-flex-cr-system-with-lli-fda-510k.jpg K192894 - Vita Flex CR System with LLI K192894 is a FDA 510(k) cleared radiology medical device. Manufacturer: Carestream Health, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k193203/ 2020-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k193203-mojave-expandable-interbody-system-fda-510k.jpg K193203 - MOJAVE Expandable Interbody System K193203 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: K2m, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k200132/ 2020-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k200132-ashvins-fda-510k.jpg K200132 - Ashvins K200132 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medicalcommunications GmbH. Cleared Feb 2020. https://www.510kdatabase.net/k200179/ 2020-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k200179-collaboration-live-fda-510k.jpg K200179 - Collaboration Live K200179 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Health Care. Cleared Feb 2020. https://www.510kdatabase.net/k193466/ 2020-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k193466-swan-ganz-catheters-fda-510k.jpg K193466 - Swan-Ganz Catheters K193466 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Feb 2020. https://www.510kdatabase.net/k193554/ 2020-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k193554-aptus-forearm-shaft-plates-and-aptus-fda-510k.jpg K193554 - APTUS® Forearm Shaft Plates and APTUS® Wrist 2.5 System K193554 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medartis AG. Cleared Feb 2020. https://www.510kdatabase.net/k191346/ 2020-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k191346-blackrock-neurocog-subdural-cortical-fda-510k.jpg K191346 - Blackrock NeuroCoG Subdural Cortical Electrodes (Strips and Grids) K191346 is a FDA 510(k) cleared neurology medical device. Manufacturer: Blackrock Microsystems. Cleared Feb 2020. https://www.510kdatabase.net/k191360/ 2020-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k191360-i-stat-chem8-cartridge-with-the-i-stat-fda-510k.jpg K191360 - i-STAT CHEM8+ cartridge with the i-STAT 1 System K191360 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Point of Care, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k191364/ 2020-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k191364-t-tas-01-total-thrombus-formation-fda-510k.jpg K191364 - T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 01 K191364 is a FDA 510(k) cleared hematology medical device. Manufacturer: Fujimori Kogyo, Co., Ltd.. Cleared Feb 2020. https://www.510kdatabase.net/k191737/ 2020-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k191737-the-graft-bone-substitute-fda-510k.jpg K191737 - The Graft Bone Substitute K191737 is a FDA 510(k) cleared dental medical device. Manufacturer: Purgo Biologics, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k191785/ 2020-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k191785-orion-lifespan-meg-fda-510k.jpg K191785 - Orion LifeSpan MEG K191785 is a FDA 510(k) cleared neurology medical device. Manufacturer: Compumedics Limited. Cleared Feb 2020. https://www.510kdatabase.net/k192120/ 2020-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k192120-venner-pneux-ett-endotracheal-tube-6-fda-510k.jpg K192120 - Venner PneuX™ ETT (Endotracheal Tube) 6 mm, Venner PneuX™ ETT (Endotracheal Tube) 7 mm, Venner PneuX™ ETT (Endotracheal Tube) 8 mm, Venner PneuX™ ETT (Endotracheal Tube) 9 mm K192120 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Venner Medical (Singapore) Pte, Ltd.. Cleared Feb 2020. https://www.510kdatabase.net/k192143/ 2020-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k192143-maximus-system-fda-510k.jpg K192143 - Maximus System K192143 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Hill-Rom Services Pte, Ltd.. Cleared Feb 2020. https://www.510kdatabase.net/k192277/ 2020-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k192277-cardiq-flow-fda-510k.jpg K192277 - CardIQ Flow K192277 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems SCS. Cleared Feb 2020. https://www.510kdatabase.net/k192372/ 2020-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k192372-ascend-image-viewer-fda-510k.jpg K192372 - ASCEND Image Viewer K192372 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ascend Hit. Cleared Feb 2020. https://www.510kdatabase.net/k192662/ 2020-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k192662-capsocam-plus-sv-3-capsule-endoscopy-fda-510k.jpg K192662 - CapsoCam Plus (SV-3) Capsule Endoscopy System K192662 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: CapsoVision, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k192923/ 2020-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k192923-vitrea-software-package-fda-510k.jpg K192923 - Vitrea Software Package K192923 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Feb 2020. https://www.510kdatabase.net/k193120/ 2020-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k193120-real-intelligence-cori-fda-510k.jpg K193120 - Real Intelligence Cori K193120 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Blue Belt Technologies, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k193152/ 2020-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k193152-affinity-fda-510k.jpg K193152 - Affinity K193152 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hermes Medical Solutions AB. Cleared Feb 2020. https://www.510kdatabase.net/k193245/ 2020-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k193245-dunamis-punchtac-suture-anchors-fda-510k.jpg K193245 - Dunamis PunchTac Suture Anchors K193245 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Dunamis, LLC. Cleared Feb 2020. https://www.510kdatabase.net/k193248/ 2020-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k193248-biograph-vision-biograph-mct-family-of-fda-510k.jpg K193248 - Biograph Vision, Biograph mCT Family of PET/CTs K193248 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k193475/ 2020-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k193475-onetouch-verio-reflect-blood-glucose-fda-510k.jpg K193475 - OneTouch Verio Reflect Blood Glucose Monitoring System K193475 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Lifescan Europe GmbH. Cleared Feb 2020. https://www.510kdatabase.net/k193502/ 2020-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k193502-tgs-universal-headrest-with-mounting-arm-fda-510k.jpg K193502 - TGS Universal Headrest with Mounting Arm K193502 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Stryker Ent. Cleared Feb 2020. https://www.510kdatabase.net/k193567/ 2020-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k193567-vitek-2-ast-gram-negative-polymyxin-b-fda-510k.jpg K193567 - VITEK 2 AST- Gram Negative Polymyxin B (<=0.25 – >=16 ug/mL) K193567 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k193644/ 2020-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k193644-e-com-dr-2000-dr-fda-510k.jpg K193644 - E-COM DR-2000 DR K193644 is a FDA 510(k) cleared radiology medical device. Manufacturer: Livermoretech, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k200083/ 2020-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k200083-emba-hourglass-peripheral-embolization-fda-510k.jpg K200083 - EMBA Hourglass Peripheral Embolization Device (PED) K200083 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Embolic Acceleration, LLC. Cleared Feb 2020. https://www.510kdatabase.net/k183024/ 2020-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k183024-implacil-implant-system-fda-510k.jpg K183024 - Implacil Implant System K183024 is a FDA 510(k) cleared dental medical device. Manufacturer: Implacil DE Bortoli Material Odontologico Ltda. Cleared Feb 2020. https://www.510kdatabase.net/k190882/ 2020-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k190882-xenosure-biologic-patch-fda-510k.jpg K190882 - XenoSure Biologic Patch K190882 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lemaitre Vascular. Cleared Feb 2020. https://www.510kdatabase.net/k190909/ 2020-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k190909-artisential-bipolar-fenestrated-forceps-fda-510k.jpg K190909 - ArtiSential Bipolar Fenestrated Forceps K190909 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Livsmed, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k191689/ 2020-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k191689-elegard-patient-positioning-system-fda-510k.jpg K191689 - EleGARD Patient Positioning System K191689 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Minnesota Resuscitation Solutions, D.B.D Advancedcpr Solutio. Cleared Feb 2020. https://www.510kdatabase.net/k191828/ 2020-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k191828-vathin-video-bronchoscope-system-fda-510k.jpg K191828 - Vathin Video Bronchoscope System K191828 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Hunan Vathin Medical Instrument Co., Ltd.. Cleared Feb 2020. https://www.510kdatabase.net/k191829/ 2020-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k191829-microlife-non-contact-infrared-fda-510k.jpg K191829 - Microlife Non-Contact Infrared Forehead Thermometer K191829 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Microlife Intellectual Property GmbH. Cleared Feb 2020. https://www.510kdatabase.net/k191966/ 2020-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k191966-newprim-system-fda-510k.jpg K191966 - NewPrim System K191966 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Brm Extremities. Cleared Feb 2020. https://www.510kdatabase.net/k192022/ 2020-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k192022-diatemp-flow-fda-510k.jpg K192022 - DiaTemp Flow K192022 is a FDA 510(k) cleared dental medical device. Manufacturer: DiaDent Group International. Cleared Feb 2020. https://www.510kdatabase.net/k192158/ 2020-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k192158-diatemp-fda-510k.jpg K192158 - DiaTemp K192158 is a FDA 510(k) cleared dental medical device. Manufacturer: DiaDent Group International. Cleared Feb 2020. https://www.510kdatabase.net/k192233/ 2020-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k192233-led-curing-light-fda-510k.jpg K192233 - LED Curing Light K192233 is a FDA 510(k) cleared dental medical device. Manufacturer: Foshan Cicada Dental Instrument Co, Ltd.. Cleared Feb 2020. https://www.510kdatabase.net/k192414/ 2020-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k192414-praxiject-09-nacl-fda-510k.jpg K192414 - Praxiject 0.9% NaCl K192414 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medxl, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k192557/ 2020-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k192557-youjia-unscented-tampon-with-plastic-fda-510k.jpg K192557 - Youjia Unscented Tampon with Plastic Applicators K192557 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Qingdao Youjia Hygiene Technology Co., Ltd.. Cleared Feb 2020. https://www.510kdatabase.net/k192614/ 2020-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k192614-meg-ball-attachment-system-meg-loc-fda-510k.jpg K192614 - Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment K192614 is a FDA 510(k) cleared dental medical device. Manufacturer: Megagen Implant Co., Ltd.. Cleared Feb 2020. https://www.510kdatabase.net/k192828/ 2020-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k192828-aquilion-one-tsx-306a3-v100-with-fda-510k.jpg K192828 - Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System K192828 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Feb 2020. https://www.510kdatabase.net/k193168/ 2020-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k193168-agilon-moldable-fda-510k.jpg K193168 - Agilon Moldable K193168 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biogennix, LLC. Cleared Feb 2020. https://www.510kdatabase.net/k193224/ 2020-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k193224-daytona-small-stature-growth-rod-fda-510k.jpg K193224 - Daytona® Small Stature Growth Rod Conversion Set K193224 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared Feb 2020. https://www.510kdatabase.net/k193232/ 2020-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k193232-emprint-ablation-system-with-fda-510k.jpg K193232 - Emprint Ablation System with Thermosphere Technology, Emprint SX Ablation Platform with Thermosphere Technology K193232 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien, LLC. Cleared Feb 2020. https://www.510kdatabase.net/k193472/ 2020-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k193472-orthocircle-spine-pedicle-screw-system-fda-510k.jpg K193472 - OrthoCircle Spine Pedicle Screw System K193472 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthocircle Spine. Cleared Feb 2020. https://www.510kdatabase.net/k193489/ 2020-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k193489-advia-centaur-br-fda-510k.jpg K193489 - ADVIA Centaur BR K193489 is a FDA 510(k) cleared immunology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k193498/ 2020-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k193498-infinitt-rt-pacs-fda-510k.jpg K193498 - Infinitt RT PACS K193498 is a FDA 510(k) cleared radiology medical device. Manufacturer: Infinitt Healthcare Co., Ltd.. Cleared Feb 2020. https://www.510kdatabase.net/k200079/ 2020-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k200079-clearpoint-system-and-accessories-fda-510k.jpg K200079 - ClearPoint System and Accessories K200079 is a FDA 510(k) cleared neurology medical device. Manufacturer: Mri Interventions, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k191235/ 2020-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k191235-leltek-ultrasound-imaging-system-fda-510k.jpg K191235 - Leltek Ultrasound Imaging System K191235 is a FDA 510(k) cleared radiology medical device. Manufacturer: Leltek, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k193178/ 2020-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k193178-biograph-horizon-fda-510k.jpg K193178 - Biograph Horizon K193178 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solution USA, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k191202/ 2020-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k191202-capenergy-c100-c200-c300-c400-c50-fda-510k.jpg K191202 - CAPENERGY - C100, C200, C300, C400, C50 K191202 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Capenergy Medical S.L.. Cleared Feb 2020. https://www.510kdatabase.net/k191453/ 2020-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k191453-cervitec-f-fda-510k.jpg K191453 - Cervitec F K191453 is a FDA 510(k) cleared dental medical device. Manufacturer: Ivoclar Vivadent, AG. Cleared Feb 2020. https://www.510kdatabase.net/k192165/ 2020-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k192165-acteon-imaging-suite-fda-510k.jpg K192165 - Acteon Imaging Suite K192165 is a FDA 510(k) cleared radiology medical device. Manufacturer: De Gotzen S.R.L.. Cleared Feb 2020. https://www.510kdatabase.net/k192596/ 2020-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k192596-ulab-systems-dental-aligner-kit-fda-510k.jpg K192596 - ULab Systems Dental Aligner Kit K192596 is a FDA 510(k) cleared dental medical device. Manufacturer: Ulab Systems, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k193013/ 2020-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k193013-acqmap-high-resolution-imaging-and-fda-510k.jpg K193013 - AcQMap High Resolution Imaging and Mapping System K193013 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Acutus Medical, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k200182/ 2020-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k200182-ezray-air-portable-model-vex-p300-fda-510k.jpg K200182 - EzRay Air Portable (Model: VEX-P300) K200182 is a FDA 510(k) cleared radiology medical device. Manufacturer: VATECH Co., Ltd.. Cleared Feb 2020. https://www.510kdatabase.net/k190192/ 2020-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k190192-k3pro-konus-new-abutments-and-implants-fda-510k.jpg K190192 - K3Pro Konus New Abutments and Implants K190192 is a FDA 510(k) cleared dental medical device. Manufacturer: Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG. Cleared Feb 2020. https://www.510kdatabase.net/k191919/ 2020-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k191919-elos-accurate-hybrid-base-fda-510k.jpg K191919 - Elos Accurate Hybrid Base K191919 is a FDA 510(k) cleared dental medical device. Manufacturer: Elos Medtech Pinol A/S. Cleared Feb 2020. https://www.510kdatabase.net/k192203/ 2020-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k192203-jo-for-him-h2o-gel-original-personal-fda-510k.jpg K192203 - JO for Him H2O Gel Original Personal Lubricant K192203 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: United Consortium. Cleared Feb 2020. https://www.510kdatabase.net/k192377/ 2020-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k192377-ethos-treatment-management-ethos-fda-510k.jpg K192377 - Ethos Treatment Management, Ethos Treatment Planning, Ethos Radiotherapy System, Halcyon K192377 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k192749/ 2020-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k192749-dermadry-fda-510k.jpg K192749 - Dermadry K192749 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Dermadry Laboratories, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k192841/ 2020-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k192841-inpen-system-fda-510k.jpg K192841 - InPen System K192841 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Companion Medical, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k192846/ 2020-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k192846-argen-clear-aligner-argen-clear-fda-510k.jpg K192846 - Argen Clear Aligner, Argen Clear Aligner Premium K192846 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Corporation. Cleared Feb 2020. https://www.510kdatabase.net/k193156/ 2020-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k193156-arthrex-mini-comprehensive-fixation-fda-510k.jpg K193156 - Arthrex Mini Comprehensive Fixation System - 1.0mm Screws K193156 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k193165/ 2020-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k193165-mectafix-cl-fixation-button-with-fda-510k.jpg K193165 - MectaFix CL Fixation Button with Continuous Loop K193165 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Feb 2020. https://www.510kdatabase.net/k193587/ 2020-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k193587-sutter-swyng-non-stick-bipolar-forceps-fda-510k.jpg K193587 - Sutter Swyng non-stick bipolar forceps, single-use K193587 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sutter Medizintechnik GmbH. Cleared Feb 2020. https://www.510kdatabase.net/k200065/ 2020-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k200065-cobas-influenza-ab-nucleic-acid-test-fda-510k.jpg K200065 - cobas Influenza A/B Nucleic acid test for use on the cobas Liat System, cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System, cobas Strep A Nucleic acid test for use on the cobas Liat System K200065 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Molecular Systems, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k200130/ 2020-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k200130-must-mini-posterior-cervical-screws-fda-510k.jpg K200130 - M.U.S.T. MINI Posterior Cervical Screws System K200130 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Feb 2020. https://www.510kdatabase.net/den190038/ 2020-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/den190038-surfacer-inside-out-access-catheter-fda-510k.jpg DEN190038 - Surfacer Inside-Out Access Catheter System DEN190038 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bluegrass Vascular Technologies, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k182927/ 2020-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k182927-pulmonary-cytology-brush-fda-510k.jpg K182927 - Pulmonary Cytology Brush K182927 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Hobbs Medical, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k183678/ 2020-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k183678-i-stat-chem8-cartridge-with-the-i-stat-fda-510k.jpg K183678 - i-STAT CHEM8+ cartridge with the i-STAT 1 System K183678 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Point of Care, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k183688/ 2020-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k183688-i-stat-chem8-cartridge-with-the-i-stat-fda-510k.jpg K183688 - i-STAT CHEM8+ cartridge with the i-STAT 1 System K183688 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Point of Care, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k190259/ 2020-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k190259-vesta-rf-cannula-fda-510k.jpg K190259 - Vesta RF Cannula K190259 is a FDA 510(k) cleared neurology medical device. Manufacturer: Biomerics. Cleared Feb 2020. https://www.510kdatabase.net/k191298/ 2020-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k191298-i-stat-chem8-cartridge-with-the-i-stat-fda-510k.jpg K191298 - i-STAT CHEM8+ cartridge with the i-STAT 1 System K191298 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Point of Care, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k191347/ 2020-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k191347-paragon-xhd-diagnostic-ultrasound-system-fda-510k.jpg K191347 - Paragon XHD Diagnostic Ultrasound System K191347 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Wisonic Medical Technology Co. , Ltd.. Cleared Feb 2020. https://www.510kdatabase.net/k191416/ 2020-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k191416-desara-one-single-incision-sling-fda-510k.jpg K191416 - Desara One Single Incision Sling System, 1 Pack K191416 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Caldera Medical, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k191975/ 2020-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k191975-elefix-v-paste-for-eeg-emg-fda-510k.jpg K191975 - Elefix V Paste for EEG & EMG K191975 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nihon Kohden Corporation. Cleared Feb 2020. https://www.510kdatabase.net/k192273/ 2020-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k192273-diaetch-economic-package-type-a-fda-510k.jpg K192273 - DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro Kit K192273 is a FDA 510(k) cleared dental medical device. Manufacturer: DiaDent Group International. Cleared Feb 2020. https://www.510kdatabase.net/k192527/ 2020-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k192527-rochal-antimicrobial-wound-gel-fda-510k.jpg K192527 - Rochal Antimicrobial Wound Gel K192527 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Rochal Industries, LLC. Cleared Feb 2020. https://www.510kdatabase.net/k193103/ 2020-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k193103-neobase-2-non-derivatized-msms-kit-fda-510k.jpg K193103 - NeoBase 2 Non-derivatized MSMS Kit K193103 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Perkinelmer, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k193129/ 2020-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k193129-yukon-oct-spinal-system-fda-510k.jpg K193129 - Yukon OCT Spinal System K193129 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: K2m, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k193154/ 2020-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k193154-3m-attest-super-rapid-5-steam-plus-fda-510k.jpg K193154 - 3M Attest Super Rapid 5 Steam-Plus Challenge Pack K193154 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Feb 2020. https://www.510kdatabase.net/k200117/ 2020-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k200117-trevo-nxt-provue-retriever-fda-510k.jpg K200117 - Trevo NXT ProVue Retriever K200117 is a FDA 510(k) cleared neurology medical device. Manufacturer: Stryker. Cleared Feb 2020. https://www.510kdatabase.net/den190040/ 2020-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/den190040-caption-guidance-fda-510k.jpg DEN190040 - Caption Guidance DEN190040 is a FDA 510(k) cleared radiology medical device. Manufacturer: Bay Labs, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k190800/ 2020-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k190800-cosmed-q-nrg-q-nrg-portable-metabolic-fda-510k.jpg K190800 - Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors K190800 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Cosmed Srl. Cleared Feb 2020. https://www.510kdatabase.net/k191290/ 2020-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k191290-ancora-nerve-block-catheter-set-fda-510k.jpg K191290 - Ancora Nerve Block Catheter Set K191290 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Ancora Medical Technology. Cleared Feb 2020. https://www.510kdatabase.net/k191411/ 2020-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k191411-ahyes-ob-coco-personal-lubricant-fda-510k.jpg K191411 - Ah!Yes Ob Coco Personal Lubricant K191411 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Bio-Tech Lubricants, Ltd.. Cleared Feb 2020. https://www.510kdatabase.net/k191529/ 2020-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k191529-da-vinci-xi-surgical-system-da-vinci-x-fda-510k.jpg K191529 - da Vinci Xi Surgical System, da Vinci X Surgical System K191529 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical. Cleared Feb 2020. https://www.510kdatabase.net/k191571/ 2020-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k191571-uv-radiation-treatment-system-fda-510k.jpg K191571 - UV Radiation Treatment System K191571 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Xuzhou Yongkang Electronic Science Technology Co., Ltd.. Cleared Feb 2020. https://www.510kdatabase.net/k191890/ 2020-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k191890-elos-accurate-customized-abutment-fda-510k.jpg K191890 - Elos Accurate Customized Abutment K191890 is a FDA 510(k) cleared dental medical device. Manufacturer: Elos Medtech Pinol A/S. Cleared Feb 2020. https://www.510kdatabase.net/k192002/ 2020-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k192002-lucy-point-of-care-magnetic-resonance-fda-510k.jpg K192002 - Lucy Point-of-Care Magnetic Resonance Imaging Device K192002 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hyperfine Research, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k192757/ 2020-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k192757-vitalpatch-5d-biosensor-single-fda-510k.jpg K192757 - VitalPatch 5D Biosensor - single, VitalPatch 7D Biosensor - single, VitalPatch 5D Biosensor – bag of 20, VitalPatch 7D Biosensor – bag of 20 K192757 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vitalconnect, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k193461/ 2020-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k193461-mectalock-all-suture-anchors-fda-510k.jpg K193461 - MectaLock All-Suture Anchors K193461 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Feb 2020. https://www.510kdatabase.net/k193521/ 2020-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k193521-steerable-plateau-ti-fda-510k.jpg K193521 - Steerable Plateau Ti K193521 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k193610/ 2020-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k193610-breathid-smart-system-fda-510k.jpg K193610 - BreathID Smart System K193610 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Exalenz Bioscience , Ltd.. Cleared Feb 2020. https://www.510kdatabase.net/k180935/ 2020-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k180935-infinity-infinity-cross-flex-dental-fda-510k.jpg K180935 - Infinity / Infinity Cross Flex Dental Systems K180935 is a FDA 510(k) cleared dental medical device. Manufacturer: Olsen Industria E Comercio S.A.. Cleared Feb 2020. https://www.510kdatabase.net/k192127/ 2020-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k192127-respire-pink-at-hard-hardsoft-ef-fda-510k.jpg K192127 - Respire Pink AT (Hard, Hard/Soft, EF) K192127 is a FDA 510(k) cleared dental medical device. Manufacturer: Respire Medical Holdings. Cleared Feb 2020. https://www.510kdatabase.net/k192785/ 2020-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k192785-optiscanner-5000-glucose-monitoring-fda-510k.jpg K192785 - OptiScanner® 5000 Glucose Monitoring System K192785 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Optiscan Biomedical Corporation. Cleared Feb 2020. https://www.510kdatabase.net/k192806/ 2020-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k192806-dentca-crown-and-bridge-fda-510k.jpg K192806 - DENTCA Crown and Bridge K192806 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentca, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k193396/ 2020-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k193396-perla-tl-posterior-osteosynthesis-system-fda-510k.jpg K193396 - PERLA® TL posterior osteosynthesis system K193396 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spineart. Cleared Feb 2020. https://www.510kdatabase.net/k200038/ 2020-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k200038-endosee-system-fda-510k.jpg K200038 - Endosee System K200038 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: CooperSurgical, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k200170/ 2020-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k200170-spinenet-ssp-system-fda-510k.jpg K200170 - SpineNet SSP System K200170 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinenet, LLC. Cleared Feb 2020. https://www.510kdatabase.net/k183148/ 2020-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k183148-okland-patient-return-electrode-pad-fda-510k.jpg K183148 - OKLand Patient Return Electrode Pad K183148 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Auckland Medical Polymer(Tianjin) Co., Ltd.. Cleared Feb 2020. https://www.510kdatabase.net/k191532/ 2020-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k191532-the-caterpillar-and-caterpillar-micro-fda-510k.jpg K191532 - The Caterpillar and Caterpillar Micro Arterial Embolization Devices K191532 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k191832/ 2020-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k191832-kurin-blood-culture-collection-set-fda-510k.jpg K191832 - Kurin Blood Culture Collection Set with Kurin Lock Technology, Push-Button Needle (Product models M-21221, M-21223, D-21221, D-21223, T-21221, T-21223) K191832 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Kurin, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k192688/ 2020-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k192688-s-clean-sq-sl-implant-system-regular-fda-510k.jpg K192688 - s-Clean SQ-SL Implant System Regular K192688 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentis Co., Ltd.. Cleared Feb 2020. https://www.510kdatabase.net/k193320/ 2020-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k193320-kmti-tesera-sa-anterior-lumbar-fda-510k.jpg K193320 - KMTI Tesera SA Anterior Lumbar Interbody Fusion (ALIF) System K193320 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Kyocera Medical Technologies, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k193324/ 2020-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k193324-motion-correction-system-fda-510k.jpg K193324 - Motion Correction System K193324 is a FDA 510(k) cleared radiology medical device. Manufacturer: Kineticor, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k193398/ 2020-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k193398-summit-duofix-ha-coating-fda-510k.jpg K193398 - Summit DuoFix HA Coating K193398 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k200050/ 2020-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k200050-akesis-galaxy-rtx-fda-510k.jpg K200050 - Akesis Galaxy RTx K200050 is a FDA 510(k) cleared radiology medical device. Manufacturer: Akesis, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k190842/ 2020-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k190842-comus-locking-plate-systems-fda-510k.jpg K190842 - Comus Locking Plate systems K190842 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Jiangsu Trauhui Medical Instrument Co., Ltd.. Cleared Feb 2020. https://www.510kdatabase.net/k190962/ 2020-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k190962-bella-mu-fda-510k.jpg K190962 - Bella-mu K190962 is a FDA 510(k) cleared general hospital medical device. Manufacturer: U-Needle B.V.. Cleared Feb 2020. https://www.510kdatabase.net/k190966/ 2020-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k190966-katalyst-training-system-fda-510k.jpg K190966 - Katalyst Training System K190966 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Katalyst, Inc.. Cleared Feb 2020. https://www.510kdatabase.net/k192579/ 2020-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k192579-x-guide-surgical-navigation-system-fda-510k.jpg K192579 - X-Guide Surgical Navigation System K192579 is a FDA 510(k) cleared dental medical device. Manufacturer: X-Nav Technologies, LLC. Cleared Feb 2020. https://www.510kdatabase.net/k193128/ 2020-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k193128-mako-total-hip-application-fda-510k.jpg K193128 - Mako Total Hip Application K193128 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Mako Surgical Corp.. Cleared Feb 2020. https://www.510kdatabase.net/k200030/ 2020-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k200030-optima-coil-system-fda-510k.jpg K200030 - Optima Coil System K200030 is a FDA 510(k) cleared neurology medical device. Manufacturer: Balt USA, LLC. Cleared Feb 2020. https://www.510kdatabase.net/k191330/ 2020-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k191330-arc-enterocuff-fda-510k.jpg K191330 - Arc Enterocuff K191330 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boddingtons Plastics, Ltd.. Cleared Jan 2020. https://www.510kdatabase.net/k191539/ 2020-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k191539-15t-endorectal-coil-30t-endorectal-fda-510k.jpg K191539 - 1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support K191539 is a FDA 510(k) cleared radiology medical device. Manufacturer: Rapid Biomedical GmbH. Cleared Jan 2020. https://www.510kdatabase.net/k192163/ 2020-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k192163-ttc-phantom-intramedullary-nail-system-fda-510k.jpg K192163 - TTC Phantom® Intramedullary Nail System K192163 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paragon 28, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k192234/ 2020-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k192234-actipatch-fda-510k.jpg K192234 - ActiPatch K192234 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Bioelectronics Corporation. Cleared Jan 2020. https://www.510kdatabase.net/k192462/ 2020-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k192462-syngomr-applications-fda-510k.jpg K192462 - syngo.MR Applications K192462 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k192535/ 2020-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k192535-unshaded-dental-zirconia-and-pre-fda-510k.jpg K192535 - Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia K192535 is a FDA 510(k) cleared dental medical device. Manufacturer: Qinhuangdao Audental Metal Technology Co., Ltd.. Cleared Jan 2020. https://www.510kdatabase.net/k193192/ 2020-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k193192-tamper-evident-cap-fda-510k.jpg K193192 - Tamper Evident Cap K193192 is a FDA 510(k) cleared general hospital medical device. Manufacturer: International Medical Industries, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k193257/ 2020-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k193257-acuson-sequoia-diagnostic-ultrasound-fda-510k.jpg K193257 - ACUSON Sequoia Diagnostic Ultrasound System K193257 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k193258/ 2020-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k193258-prolift-expandable-system-fda-510k.jpg K193258 - ProLift Expandable System K193258 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k193270/ 2020-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k193270-caplox-iitowerlox-mis-pedicle-screw-fda-510k.jpg K193270 - CapLOX II®/TowerLOX® MIS Pedicle Screw System K193270 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Captiva Spine, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k193284/ 2020-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k193284-physica-lmc-knee-system-fda-510k.jpg K193284 - Physica LMC Knee System K193284 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Lima Corporate S.P.A.. Cleared Jan 2020. https://www.510kdatabase.net/k193480/ 2020-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k193480-bioeasy-multi-drug-test-cup-fda-510k.jpg K193480 - BIOEASY Multi-Drug Test Cup K193480 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Shenzhen Bioeasy Biotechnology Co., Ltd.. Cleared Jan 2020. https://www.510kdatabase.net/k200018/ 2020-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k200018-had1717mc-fda-510k.jpg K200018 - HAD1717MC K200018 is a FDA 510(k) cleared radiology medical device. Manufacturer: H&Abyz. Cleared Jan 2020. https://www.510kdatabase.net/k190734/ 2020-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k190734-linshom-respiratory-monitoring-device-fda-510k.jpg K190734 - Linshom Respiratory Monitoring Device (LRMD) K190734 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Linshom Management, LLC. Cleared Jan 2020. https://www.510kdatabase.net/k190956/ 2020-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k190956-scs-17-01-fda-510k.jpg K190956 - SCS 17-01 K190956 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Anika Therapeutics, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k191254/ 2020-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k191254-endoclot-fda-510k.jpg K191254 - EndoClot K191254 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Endoclot Plus Co., Ltd.. Cleared Jan 2020. https://www.510kdatabase.net/k192339/ 2020-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k192339-teslatome-bipolar-sphincterotome-tesla-fda-510k.jpg K192339 - TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord K192339 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Wilson-Cook Medical, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k192397/ 2020-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k192397-trudi-navigation-system-fda-510k.jpg K192397 - TruDi Navigation System K192397 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Biosense Webster. Cleared Jan 2020. https://www.510kdatabase.net/k192889/ 2020-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k192889-neo-fda-510k.jpg K192889 - Neo K192889 is a FDA 510(k) cleared neurology medical device. Manufacturer: Eemagine Medical Imaging Solutions GmbH. Cleared Jan 2020. https://www.510kdatabase.net/k192941/ 2020-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k192941-hysil-super-fast-impression-materials-fda-510k.jpg K192941 - HySil Super Fast Impression Materials K192941 is a FDA 510(k) cleared dental medical device. Manufacturer: Osstem Implant Co., Ltd.. Cleared Jan 2020. https://www.510kdatabase.net/k193057/ 2020-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k193057-attune-all-polyethylene-tibia-fda-510k.jpg K193057 - ATTUNE All-Polyethylene Tibia K193057 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Ireland UC. Cleared Jan 2020. https://www.510kdatabase.net/k193060/ 2020-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k193060-noritake-super-porcelain-ex-3-fda-510k.jpg K193060 - Noritake Super Porcelain EX-3 K193060 is a FDA 510(k) cleared dental medical device. Manufacturer: Kuraray Noritake Dental, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k193339/ 2020-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k193339-gtk-veress-needles-fda-510k.jpg K193339 - GTK Veress Needles K193339 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Guangzhou T.K Medical Instrument Co., Ltd.. Cleared Jan 2020. https://www.510kdatabase.net/k183106/ 2020-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k183106-truabutment-ds-fda-510k.jpg K183106 - TruAbutment DS K183106 is a FDA 510(k) cleared dental medical device. Manufacturer: Truabutment, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k191323/ 2020-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k191323-carescape-b850-fda-510k.jpg K191323 - Carescape B850 K191323 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: GE Healthcare Finland Oy. Cleared Jan 2020. https://www.510kdatabase.net/k191380/ 2020-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k191380-quantum-total-ankle-prosthesis-fda-510k.jpg K191380 - Quantum® Total Ankle Prosthesis K191380 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: In2bones Sas. Cleared Jan 2020. https://www.510kdatabase.net/k191472/ 2020-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k191472-biopsy-needle-fda-510k.jpg K191472 - Biopsy Needle K191472 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ushare Medical, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k191498/ 2020-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k191498-cook-cope-loop-nephrostomy-set-fda-510k.jpg K191498 - Cook-Cope Loop Nephrostomy Set, Ultrathane Nephrostomy Set with Mac-Loc, Ultrathane Suprapubic Set with Mac-Loc K191498 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Jan 2020. https://www.510kdatabase.net/k191677/ 2020-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k191677-mectatap-ti-suture-anchor-fda-510k.jpg K191677 - MectaTap TI Suture Anchor K191677 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Jan 2020. https://www.510kdatabase.net/k191837/ 2020-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k191837-unismile-clear-aligner-system-fda-510k.jpg K191837 - UniSmile Clear Aligner System K191837 is a FDA 510(k) cleared dental medical device. Manufacturer: Vitang Technology, LLC. Cleared Jan 2020. https://www.510kdatabase.net/k191926/ 2020-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k191926-vita-vionic-bond-fda-510k.jpg K191926 - VITA VIONIC Bond K191926 is a FDA 510(k) cleared dental medical device. Manufacturer: Vita Zanhnfabrik H. Rauter GmbH Co.. Cleared Jan 2020. https://www.510kdatabase.net/k191937/ 2020-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k191937-ezvena-ipc-ezvena-sqs-fda-510k.jpg K191937 - Ezvena IPC, Ezvena SQS K191937 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Eezcare Medical Corp. Cleared Jan 2020. https://www.510kdatabase.net/k191989/ 2020-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k191989-wvsm-wireless-vital-signs-monitor-rwc-fda-510k.jpg K191989 - WVSM (Wireless Vital Signs Monitor) RWC + miniCap K191989 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Athena Gtx. Cleared Jan 2020. https://www.510kdatabase.net/k192585/ 2020-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k192585-bosley-revitalizer-96-laser-cap-bosley-fda-510k.jpg K192585 - Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap K192585 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC. Cleared Jan 2020. https://www.510kdatabase.net/k193051/ 2020-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k193051-liaison-lyme-total-antibody-plus-fda-510k.jpg K193051 - LIAISON Lyme Total Antibody Plus, LIAISON Lyme Total Antibody Plus Control Set K193051 is a FDA 510(k) cleared microbiology medical device. Manufacturer: DiaSorin, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k193099/ 2020-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k193099-anatomical-shoulder-system-fda-510k.jpg K193099 - Anatomical Shoulder System K193099 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer GmbH. Cleared Jan 2020. https://www.510kdatabase.net/k193642/ 2020-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k193642-dexcom-g6-glucose-program-continuous-fda-510k.jpg K193642 - Dexcom G6 Glucose Program Continuous Glucose Monitoring (CGM) System K193642 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dexcom, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k192146/ 2020-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k192146-v-denupet-fda-510k.jpg K192146 - V-DENUPET K192146 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Vitromed GmbH. Cleared Jan 2020. https://www.510kdatabase.net/k192581/ 2020-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k192581-the-nightblocks-appliance-fda-510k.jpg K192581 - The NightBlocks Appliance K192581 is a FDA 510(k) cleared dental medical device. Manufacturer: Advanced Facialdontics, LLC. Cleared Jan 2020. https://www.510kdatabase.net/k193510/ 2020-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k193510-terason-usmart3200t-ultrasound-system-fda-510k.jpg K193510 - Terason uSmart3200T Ultrasound System K193510 is a FDA 510(k) cleared radiology medical device. Manufacturer: Teratech Corporation. Cleared Jan 2020. https://www.510kdatabase.net/k193637/ 2020-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k193637-mrh-alfa-radiographic-system-mrh-ii-fda-510k.jpg K193637 - MRH ALFA Radiographic System, MRH II Radiographic System, MRH IIE Radiographic System K193637 is a FDA 510(k) cleared radiology medical device. Manufacturer: Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.. Cleared Jan 2020. https://www.510kdatabase.net/k191715/ 2020-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k191715-endoscope-tip-protector-sterile-fda-510k.jpg K191715 - Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile K191715 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: STERIS Corporation. Cleared Jan 2020. https://www.510kdatabase.net/k192090/ 2020-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k192090-cmos-video-rhino-laryngoscope-ssu-fda-510k.jpg K192090 - CMOS Video Rhino-Laryngoscope SSU K192090 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Karl Storz SE & CO. KG. Cleared Jan 2020. https://www.510kdatabase.net/k193315/ 2020-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k193315-xenocor-articulating-xenoscope-fda-510k.jpg K193315 - Xenocor Articulating Xenoscope Laparoscope K193315 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Xenocor, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k193365/ 2020-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k193365-must-pedicle-screw-system-fda-510k.jpg K193365 - M.U.S.T. Pedicle Screw System K193365 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Jan 2020. https://www.510kdatabase.net/k193241/ 2020-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k193241-emission-computed-tomography-system-fda-510k.jpg K193241 - Emission Computed Tomography System K193241 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Jan 2020. https://www.510kdatabase.net/k193512/ 2020-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k193512-thd-procto-software-system-fda-510k.jpg K193512 - THD Procto Software System K193512 is a FDA 510(k) cleared radiology medical device. Manufacturer: Thd Spa. Cleared Jan 2020. https://www.510kdatabase.net/k191186/ 2020-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k191186-subdural-stripintraoperative-split-fda-510k.jpg K191186 - Subdural Strip/Intraoperative Split Electrode, Subdural Grid/Intraoperative Grid Electrode, Dual-Sided Interhemispheric Subdural Electrode, Multi-Strip and Slit Grid Subdural Electrode, Intraoperative Mapping Grid Subdural Electrode K191186 is a FDA 510(k) cleared neurology medical device. Manufacturer: Ad-Tech Medical Instrument Corporation. Cleared Jan 2020. https://www.510kdatabase.net/k191144/ 2020-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k191144-cellvizio-100-series-system-with-fda-510k.jpg K191144 - Cellvizio 100 Series System with Confocal Miniprobes K191144 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Mauna Kea Technologies. Cleared Jan 2020. https://www.510kdatabase.net/k191227/ 2020-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k191227-paratrooper-plantar-plate-repair-system-fda-510k.jpg K191227 - Paratrooper Plantar Plate Repair System K191227 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paragon 28, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k191249/ 2020-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k191249-carescape-b450-fda-510k.jpg K191249 - CARESCAPE B450 K191249 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: GE Healthcare Finland Oy. Cleared Jan 2020. https://www.510kdatabase.net/k191293/ 2020-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k191293-lccs-vc-s-rf-cannula-fda-510k.jpg K191293 - LCCS VC-S RF Cannula K191293 is a FDA 510(k) cleared neurology medical device. Manufacturer: Lccs Products Limited. Cleared Jan 2020. https://www.510kdatabase.net/k191406/ 2020-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k191406-kardiamobile-kardiastation-fda-510k.jpg K191406 - KardiaMobile, KardiaStation K191406 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: AliveCor, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k191432/ 2020-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k191432-cortiq-pro-fda-510k.jpg K191432 - cortiQ PRO K191432 is a FDA 510(k) cleared neurology medical device. Manufacturer: G.Tec Medical Engineering GmbH. Cleared Jan 2020. https://www.510kdatabase.net/k192014/ 2020-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k192014-sypmhony-oct-system-fda-510k.jpg K192014 - SYPMHONY™ OCT System K192014 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International SARL. Cleared Jan 2020. https://www.510kdatabase.net/k192333/ 2020-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k192333-blue-nitrile-examination-gloves-powder-fda-510k.jpg K192333 - Blue Nitrile Examination Gloves Powder Free K192333 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jr Engineering & Medical Technologies (M) Sdn. Bhd.. Cleared Jan 2020. https://www.510kdatabase.net/k192493/ 2020-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k192493-bd-cathena-tm-safety-iv-catheter-fda-510k.jpg K192493 - BD Cathena (TM) Safety IV Catheter K192493 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton Dickinson Infusion Therapy Systems, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k192523/ 2020-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k192523-cmos-video-esophagoscope-ssu-fda-510k.jpg K192523 - CMOS Video Esophagoscope SSU K192523 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Karl Storz SE & CO. KG. Cleared Jan 2020. https://www.510kdatabase.net/k192608/ 2020-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k192608-disposable-spo2-sensor-fda-510k.jpg K192608 - Disposable SpO2 Sensor K192608 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Sino-K Medical Technology Co.,Ltd. Cleared Jan 2020. https://www.510kdatabase.net/k192641/ 2020-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k192641-gemini-titan-sterilization-wrap-fda-510k.jpg K192641 - Gemini Titan Sterilization Wrap K192641 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k192859/ 2020-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k192859-caresens-s-clear-bt-blood-glucose-fda-510k.jpg K192859 - CareSens S Clear BT Blood Glucose Monitoring System K192859 is a FDA 510(k) cleared chemistry medical device. Manufacturer: I-Sens, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k192984/ 2020-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k192984-aptus-clavicle-system-fda-510k.jpg K192984 - APTUS Clavicle System K192984 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medartis AG. Cleared Jan 2020. https://www.510kdatabase.net/k193109/ 2020-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k193109-mrcat-brain-fda-510k.jpg K193109 - MRCAT brain K193109 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems MR Finland. Cleared Jan 2020. https://www.510kdatabase.net/k193223/ 2020-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k193223-persona-personalized-knee-system-fda-510k.jpg K193223 - Persona Personalized Knee System K193223 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k193246/ 2020-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k193246-stat-profile-prime-plus-analyzer-system-fda-510k.jpg K193246 - Stat Profile Prime Plus Analyzer System K193246 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Nova Biomedical Corporation. Cleared Jan 2020. https://www.510kdatabase.net/k193261/ 2020-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k193261-flightplan-for-embolization-fda-510k.jpg K193261 - FlightPlan for Embolization K193261 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems SCS. Cleared Jan 2020. https://www.510kdatabase.net/k193263/ 2020-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k193263-reprocessed-achieve-catheter-fda-510k.jpg K193263 - Reprocessed Achieve Catheter Connecting Cable K193263 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Innovative Health, LLC. Cleared Jan 2020. https://www.510kdatabase.net/k193454/ 2020-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k193454-iqon-spectral-ct-fda-510k.jpg K193454 - IQon Spectral CT K193454 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Jan 2020. https://www.510kdatabase.net/k190120/ 2020-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k190120-vinno-8-vinno-6-vinno-5-fda-510k.jpg K190120 - VINNO 8, VINNO 6, VINNO 5 K190120 is a FDA 510(k) cleared radiology medical device. Manufacturer: Vinno Technology (Suzhou) Co.,Ltd. Cleared Jan 2020. https://www.510kdatabase.net/k190271/ 2020-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k190271-fitebac-cavity-cleanser-fda-510k.jpg K190271 - FiteBac Cavity Cleanser K190271 is a FDA 510(k) cleared dental medical device. Manufacturer: Largent Health, LLC. Cleared Jan 2020. https://www.510kdatabase.net/k190839/ 2020-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k190839-gammatile-fda-510k.jpg K190839 - GammaTile K190839 is a FDA 510(k) cleared radiology medical device. Manufacturer: Gt Medical Technologies. Cleared Jan 2020. https://www.510kdatabase.net/k191014/ 2020-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k191014-elements-viewer-fda-510k.jpg K191014 - Elements Viewer K191014 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab AG. Cleared Jan 2020. https://www.510kdatabase.net/k191270/ 2020-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k191270-proneb-max-fda-510k.jpg K191270 - Proneb Max K191270 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Pari Respiratory Equipment, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k191821/ 2020-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k191821-blue-phantom-pt-fda-510k.jpg K191821 - Blue Phantom PT K191821 is a FDA 510(k) cleared radiology medical device. Manufacturer: Iba Dosimetry GmbH. Cleared Jan 2020. https://www.510kdatabase.net/k192025/ 2020-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k192025-sterrad-velocity-biological-fda-510k.jpg K192025 - STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader K192025 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Advanced Sterilization Products (Asp). Cleared Jan 2020. https://www.510kdatabase.net/k192092/ 2020-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k192092-seca-medical-vital-signs-analyzer-535-fda-510k.jpg K192092 - Seca Medical Vital Signs Analyzer 535, Seca mVSA 535, Seca mVSA, Seca 535 K192092 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Seca GmbH & Co. KG. Cleared Jan 2020. https://www.510kdatabase.net/k192170/ 2020-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k192170-vistascan-usb-ultrasound-imaging-system-fda-510k.jpg K192170 - VistaScan USB Ultrasound Imaging System K192170 is a FDA 510(k) cleared radiology medical device. Manufacturer: Emagine Solutions Technology, LLC. Cleared Jan 2020. https://www.510kdatabase.net/k192330/ 2020-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k192330-eea-circular-stapler-with-tri-staple-fda-510k.jpg K192330 - EEA Circular Stapler with Tri-Staple Technology K192330 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien. Cleared Jan 2020. https://www.510kdatabase.net/k192349/ 2020-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k192349-bactisure-wound-lavage-fda-510k.jpg K192349 - Bactisure Wound Lavage K192349 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Next Science, LLC. Cleared Jan 2020. https://www.510kdatabase.net/k192436/ 2020-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k192436-healing-abutments-and-cover-screws-fda-510k.jpg K192436 - Healing Abutments and Cover Screws K192436 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentium Co., Ltd.. Cleared Jan 2020. https://www.510kdatabase.net/k192530/ 2020-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k192530-surefil-one-self-adhesive-composite-fda-510k.jpg K192530 - Surefil one Self-adhesive Composite Hybrid K192530 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona. Cleared Jan 2020. https://www.510kdatabase.net/k193295/ 2020-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k193295-parcus-knotless-peek-and-peek-cf-push-fda-510k.jpg K193295 - Parcus Knotless PEEK and PEEK CF Push-In Suture Anchor K193295 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Parcus Medical, LLC. Cleared Jan 2020. https://www.510kdatabase.net/k193504/ 2020-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k193504-hardydisk-ast-cefiderocol-30ug-fdc30-fda-510k.jpg K193504 - HardyDisk AST Cefiderocol 30ug (FDC30) K193504 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Hardy Diagnostics. Cleared Jan 2020. https://www.510kdatabase.net/k190837/ 2020-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k190837-internal-hex-implant-system-fda-510k.jpg K190837 - Internal Hex Implant System K190837 is a FDA 510(k) cleared dental medical device. Manufacturer: Ebi, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k190954/ 2020-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k190954-fundus-camera-fda-510k.jpg K190954 - Fundus Camera K190954 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Chongqing Bio Newvision Medical Equipment , Ltd.. Cleared Jan 2020. https://www.510kdatabase.net/k191093/ 2020-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k191093-isopure-dry-acid-dissolution-system-fda-510k.jpg K191093 - Isopure Dry Acid Dissolution System K191093 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Isopure, Corp.. Cleared Jan 2020. https://www.510kdatabase.net/k191109/ 2020-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k191109-spectra-q-fda-510k.jpg K191109 - Spectra Q K191109 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Uzinmedicare Co.. Cleared Jan 2020. https://www.510kdatabase.net/k191322/ 2020-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k191322-e-eegx-n-eegx-fda-510k.jpg K191322 - E-EEGX, N-EEGX K191322 is a FDA 510(k) cleared neurology medical device. Manufacturer: GE Healthcare Finland Oy. Cleared Jan 2020. https://www.510kdatabase.net/k192161/ 2020-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k192161-fastfit-ems-system-fda-510k.jpg K192161 - FastFit EMS System K192161 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fast Fit, LLC. Cleared Jan 2020. https://www.510kdatabase.net/k192502/ 2020-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k192502-anatomic-peek-cervical-fusion-system-fda-510k.jpg K192502 - Anatomic PEEK™ Cervical Fusion System, Anatomic PEEK™ PTC Cervical Fusion System, Capstone™ Spinal System, Capstone PTC™ Spinal System, Capstone Control™ Spinal System, Capstone Control PTC™ Spinal System, Clydesdale™ Spinal System, Clydesdale PTC™ Spinal System, Cornerstone™ PSR Cervical Fusion System, Crescent™ Spinal System, Crescent™ Spinal System Titanium, Divergence™ Anterior Cervical Fusion System (For Stand-Alone Interbody Device Only), Divergence-L™ Anterior/Oblique Lumbar Fus K192502 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k192684/ 2020-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k192684-hydropearl-microspheres-fda-510k.jpg K192684 - HydroPearl Microspheres K192684 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: MicroVention, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k192993/ 2020-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k192993-scarlet-al-t-fda-510k.jpg K192993 - SCARLET AL-T K192993 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spineart. Cleared Jan 2020. https://www.510kdatabase.net/k193574/ 2020-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k193574-q-rad-system-fda-510k.jpg K193574 - Q-Rad System K193574 is a FDA 510(k) cleared radiology medical device. Manufacturer: Carestream Health, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k193606/ 2020-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k193606-y-knot-onestep-anchor-fda-510k.jpg K193606 - Y-Knot OneStep Anchor K193606 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Conmed Corporation. Cleared Jan 2020. https://www.510kdatabase.net/k191149/ 2020-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k191149-carescape-b650-fda-510k.jpg K191149 - CARESCAPE B650 K191149 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: GE Healthcare Finland Oy. Cleared Jan 2020. https://www.510kdatabase.net/k191229/ 2020-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k191229-trapit-fda-510k.jpg K191229 - TrapIt K191229 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Imds Operations B.V.. Cleared Jan 2020. https://www.510kdatabase.net/k191425/ 2020-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k191425-hydro-temp-neonatal-skin-temperature-fda-510k.jpg K191425 - Hydro-Temp Neonatal Skin Temperature Probe Cover K191425 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Deroyal Industries, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k192564/ 2020-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k192564-disposable-gold-cup-eeg-electrodes-fda-510k.jpg K192564 - Disposable Gold Cup EEG Electrodes K192564 is a FDA 510(k) cleared neurology medical device. Manufacturer: Dymedix Diagnostics, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k192985/ 2020-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k192985-medline-glide-on-3g-vinyl-examination-fda-510k.jpg K192985 - Medline Glide-On 3G Vinyl Examination Gloves K192985 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k193370/ 2020-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k193370-nexxt-matrixx-system-fda-510k.jpg K193370 - Nexxt Matrixx System K193370 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nexxt Spine, LLC. Cleared Jan 2020. https://www.510kdatabase.net/k193566/ 2020-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k193566-zeltiq-coolsculpting-system-fda-510k.jpg K193566 - ZELTIQ CoolSculpting System K193566 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Zeltiq Aesthetics, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k193569/ 2020-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k193569-pivotm-fda-510k.jpg K193569 - PIVO(TM) K193569 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Velano Vascular. Cleared Jan 2020. https://www.510kdatabase.net/k192098/ 2020-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k192098-ezmobile-fda-510k.jpg K192098 - EzMobile K192098 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ewoosoft Co., Ltd.. Cleared Jan 2020. https://www.510kdatabase.net/k193222/ 2020-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k193222-tyber-medical-anatomical-plating-system-fda-510k.jpg K193222 - Tyber Medical Anatomical Plating System K193222 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tyber Medical, LLC. Cleared Jan 2020. https://www.510kdatabase.net/k193045/ 2020-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k193045-geko-w-2-fda-510k.jpg K193045 - geko™ W-2 K193045 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Firstkind Limited. Cleared Jan 2020. https://www.510kdatabase.net/k193548/ 2020-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k193548-mirage-hydrophilic-guidewire-x-pedion-fda-510k.jpg K193548 - Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire K193548 is a FDA 510(k) cleared neurology medical device. Manufacturer: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. Cleared Jan 2020. https://www.510kdatabase.net/k181089/ 2020-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k181089-surelead-cable-system-fda-510k.jpg K181089 - SureLead Cable System K181089 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Authentic Medical. Cleared Jan 2020. https://www.510kdatabase.net/k190306/ 2020-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k190306-amd-ritmed-assurewear-versagown-fda-510k.jpg K190306 - AMD Ritmed AssureWear VersaGown K190306 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Amd Medicom, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k190871/ 2020-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k190871-bio-tacks-orthodontic-mini-implant-fda-510k.jpg K190871 - Bio-TackS Orthodontic Mini Implant K190871 is a FDA 510(k) cleared dental medical device. Manufacturer: Biocetec Co., Ltd.. Cleared Jan 2020. https://www.510kdatabase.net/k192182/ 2020-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k192182-c015-fda-510k.jpg K192182 - C015 K192182 is a FDA 510(k) cleared radiology medical device. Manufacturer: Micronica Srl. Cleared Jan 2020. https://www.510kdatabase.net/k192211/ 2020-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k192211-soundbite-console-soundbite-active-fda-510k.jpg K192211 - SoundBite Console, SoundBite Active Wire 18 K192211 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Soundbite Medical Solution, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k192302/ 2020-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k192302-mahurkar-acute-single-lumen-catheter-fda-510k.jpg K192302 - Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter K192302 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Covidien, LLC. Cleared Jan 2020. https://www.510kdatabase.net/k192415/ 2020-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k192415-study-watch-with-irregular-pulse-monitor-fda-510k.jpg K192415 - Study Watch with Irregular Pulse Monitor K192415 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Verily Life Sciences, LLC. Cleared Jan 2020. https://www.510kdatabase.net/k192495/ 2020-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k192495-black-diamond-navigation-instruments-fda-510k.jpg K192495 - Black Diamond Navigation Instruments K192495 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osseus Fusion Systems. Cleared Jan 2020. https://www.510kdatabase.net/k192547/ 2020-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k192547-maglumi-2000-hcg-hcg-fda-510k.jpg K192547 - MAGLUMI 2000 HCG/ß-HCG K192547 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.. Cleared Jan 2020. https://www.510kdatabase.net/k192563/ 2020-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k192563-altera-gas-sampling-lines-fda-510k.jpg K192563 - Altera gas Sampling Lines K192563 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Meditera Tibbi Malzeme San VE Tic AS. Cleared Jan 2020. https://www.510kdatabase.net/k192583/ 2020-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k192583-picolazer-laser-system-fda-510k.jpg K192583 - PicoLazer Laser System K192583 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Rohrer Aesthetics, LLC. Cleared Jan 2020. https://www.510kdatabase.net/k192606/ 2020-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k192606-sac2-electrode-cream-fda-510k.jpg K192606 - SAC2 - Electrode Cream K192606 is a FDA 510(k) cleared neurology medical device. Manufacturer: Spes Medica Srl. Cleared Jan 2020. https://www.510kdatabase.net/k192635/ 2020-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k192635-powder-free-nitrile-patient-fda-510k.jpg K192635 - Powder Free Nitrile Patient Examination Gloves, Non-Sterile (Orange) K192635 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wrp Asia Pacific Sdn. Bhd.. Cleared Jan 2020. https://www.510kdatabase.net/k192761/ 2020-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k192761-asimov-mks-imaging-system-fda-510k.jpg K192761 - Asimov-MKS Imaging System K192761 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Onlume, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k192926/ 2020-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k192926-rxsight-insertion-device-fda-510k.jpg K192926 - RxSight Insertion Device K192926 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Rxsight, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k193007/ 2020-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k193007-lina-operascope-with-hdmi-cable-and-on-fda-510k.jpg K193007 - LiNA OperaScope with HDMI cable and on-board LCD - 6 units, LiNA OperaScope Recording Module K193007 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Lina Medical Aps. Cleared Jan 2020. https://www.510kdatabase.net/k193182/ 2020-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k193182-evis-exera-iii-duodenovideoscope-fda-510k.jpg K193182 - Evis Exera III Duodenovideoscope Olympus TJF-Q190V K193182 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Jan 2020. https://www.510kdatabase.net/k193507/ 2020-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k193507-merit-one-snare-system-fda-510k.jpg K193507 - Merit ONE Snare System K193507 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k193509/ 2020-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k193509-acqguide-flex-with-acqcross-qx-fda-510k.jpg K193509 - AcQGuide Flex with AcQCross QX, AcQGuide Mini with AcQCross QX K193509 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Acutus Medical, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k193543/ 2020-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k193543-colink-plating-system-fracture-and-fda-510k.jpg K193543 - CoLink Plating System, Fracture and Correction System, CoLink Mini Plating System, CoLink View Plating System, CoLink Afx Plating System K193543 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: In2bones USA, LLC. Cleared Jan 2020. https://www.510kdatabase.net/k193547/ 2020-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k193547-customizedbone-service-fda-510k.jpg K193547 - CustomizedBone Service K193547 is a FDA 510(k) cleared neurology medical device. Manufacturer: Fin-Ceramica Faenza S.P.A.. Cleared Jan 2020. https://www.510kdatabase.net/k193570/ 2020-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k193570-dental-pain-eraser-fda-510k.jpg K193570 - Dental Pain Eraser K193570 is a FDA 510(k) cleared dental medical device. Manufacturer: Synapse Dental. Cleared Jan 2020. https://www.510kdatabase.net/k193590/ 2020-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k193590-caresens-s-fit-bt-blood-glucose-fda-510k.jpg K193590 - CareSens S Fit BT Blood Glucose Monitoring System K193590 is a FDA 510(k) cleared chemistry medical device. Manufacturer: I-Sens, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k191095/ 2020-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k191095-maxxi-snore-sensor-fda-510k.jpg K191095 - Maxxi Snore Sensor K191095 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Neurovirtual USA, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k191538/ 2020-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k191538-resectr-tissue-resection-device-fda-510k.jpg K191538 - Resectr Tissue Resection Device K191538 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Boston Scientific Corporation. Cleared Jan 2020. https://www.510kdatabase.net/k191802/ 2020-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k191802-electric-breast-pump-fda-510k.jpg K191802 - Electric Breast Pump K191802 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ningbo Huiyoo Baby Products Co., Ltd.. Cleared Jan 2020. https://www.510kdatabase.net/k191831/ 2020-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k191831-mobilit-cup-fda-510k.jpg K191831 - MobiliT Cup K191831 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corin U.S.A. Limited. Cleared Jan 2020. https://www.510kdatabase.net/k192357/ 2020-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k192357-innovo-fda-510k.jpg K192357 - INNOVO K192357 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Atlantic Therapeutics, Ltd.. Cleared Jan 2020. https://www.510kdatabase.net/k192750/ 2020-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k192750-actiflip-naked-actiflip-cinch-actiflip-fda-510k.jpg K192750 - AcTiFlip Naked, AcTiFlip Cinch, AcTiFlip WHIP, GFS Ultimate Hip K192750 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Parcus Medical, LLC. Cleared Jan 2020. https://www.510kdatabase.net/k192869/ 2020-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k192869-sherpapak-lung-preservation-system-fda-510k.jpg K192869 - SherpaPak Lung Preservation System , SherpaPak Liver Transport System K192869 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Pragonix Technologies. Cleared Jan 2020. https://www.510kdatabase.net/k192942/ 2020-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k192942-allthread-titanium-suture-anchor-fda-510k.jpg K192942 - ALLthread Titanium Suture Anchor K192942 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k192956/ 2020-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k192956-auto-positioning-fda-510k.jpg K192956 - Auto Positioning K192956 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Hangwei Medical Systems Co., Ltd.. Cleared Jan 2020. https://www.510kdatabase.net/k193488/ 2020-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k193488-glidescope-bflex-38-single-use-fda-510k.jpg K193488 - GlideScope BFlex 3.8 Single-Use Bronchoscope K193488 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Verathon Medical (Canada) Ulc. Cleared Jan 2020. https://www.510kdatabase.net/k193500/ 2020-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k193500-stellar-m22-for-intense-pulsed-light-fda-510k.jpg K193500 - Stellar M22 for Intense Pulsed Light (IPL) and Laser System K193500 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lumenis, Ltd.. Cleared Jan 2020. https://www.510kdatabase.net/k193611/ 2020-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k193611-viveve-20-system-fda-510k.jpg K193611 - Viveve 2.0 System K193611 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Viveve Medical, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k181005/ 2020-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k181005-clenchguard-fda-510k.jpg K181005 - ClenchGuard K181005 is a FDA 510(k) cleared dental medical device. Manufacturer: Boyd Research, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k183284/ 2020-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k183284-intracel-rf-microneedle-system-fda-510k.jpg K183284 - INTRAcel RF Microneedle System K183284 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Jeisys Medical, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k190028/ 2020-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k190028-uno-30-fda-510k.jpg K190028 - UNO 30 K190028 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Genadyne Biotechnologies. Cleared Jan 2020. https://www.510kdatabase.net/k190981/ 2020-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k190981-nex-d2-posterior-fixation-system-fda-510k.jpg K190981 - NEX-D2 Posterior Fixation System K190981 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Next Orthosurgical. Cleared Jan 2020. https://www.510kdatabase.net/k191125/ 2020-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k191125-adas-3d-fda-510k.jpg K191125 - ADAS 3D K191125 is a FDA 510(k) cleared radiology medical device. Manufacturer: Galgo Medical S.L. Cleared Jan 2020. https://www.510kdatabase.net/k191266/ 2020-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k191266-vitalscan-ans-fda-510k.jpg K191266 - VitalScan ANS K191266 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medeia, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k191275/ 2020-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k191275-allincath-035m-pta-balloon-dilatation-fda-510k.jpg K191275 - All’InCath 035M PTA Balloon Dilatation Catheter K191275 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nexstep Medical. Cleared Jan 2020. https://www.510kdatabase.net/k192004/ 2020-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k192004-eko-analysis-software-fda-510k.jpg K192004 - Eko Analysis Software K192004 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Eko Devices, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k192251/ 2020-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k192251-livento-press-soprano-10-soprano-fda-510k.jpg K192251 - Livento Press, Soprano 10, Soprano K192251 is a FDA 510(k) cleared dental medical device. Manufacturer: Cendres & Metaux SA. Cleared Jan 2020. https://www.510kdatabase.net/k192454/ 2020-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k192454-wattson-temporary-pacing-guidewire-fda-510k.jpg K192454 - Wattson Temporary Pacing Guidewire K192454 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vascular Solutions. Cleared Jan 2020. https://www.510kdatabase.net/k193225/ 2020-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k193225-kdr-au-ddr-system-advanced-u-arm-with-fda-510k.jpg K193225 - KDR AU-DDR System Advanced U-Arm with Dynamic Digital Radiography, KDR AU System Advanced U-Arm with Static Digital Radiography K193225 is a FDA 510(k) cleared radiology medical device. Manufacturer: Konica Minolta Healthcare Americas, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k193493/ 2020-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k193493-advia-centaur-total-ige-tige-fda-510k.jpg K193493 - ADVIA Centaur Total IgE (tIgE) K193493 is a FDA 510(k) cleared immunology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k193503/ 2020-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k193503-arthrex-swivelock-suture-anchor-fda-510k.jpg K193503 - Arthrex SwiveLock Suture Anchor K193503 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k190316/ 2020-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k190316-icare-ic200-fda-510k.jpg K190316 - Icare ic200 K190316 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Icare Finland OY. Cleared Jan 2020. https://www.510kdatabase.net/k191020/ 2020-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k191020-g210-invicell-plus-with-signiphy-ph-fda-510k.jpg K191020 - G210 InviCell Plus with SignipHy pH monitoring K191020 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: CooperSurgical, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k192115/ 2020-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k192115-sable-expandable-spacer-fda-510k.jpg K192115 - SABLE Expandable Spacer K192115 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k192429/ 2020-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k192429-dental-pain-eraser-fda-510k.jpg K192429 - Dental Pain Eraser K192429 is a FDA 510(k) cleared dental medical device. Manufacturer: Synapse Dental. Cleared Jan 2020. https://www.510kdatabase.net/k192800/ 2020-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k192800-streamline-tl-spinal-fixation-system-fda-510k.jpg K192800 - Streamline TL Spinal Fixation System K192800 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.). Cleared Jan 2020. https://www.510kdatabase.net/k192920/ 2020-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k192920-oragenedx-fda-510k.jpg K192920 - Oragene®•Dx K192920 is a FDA 510(k) cleared chemistry medical device. Manufacturer: DNA Genotek, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k193188/ 2020-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k193188-miis-horus-eye-anterior-camera-fda-510k.jpg K193188 - MiiS Horus Eye Anterior Camera K193188 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Medimaging Integrated Solution, Inc (Miis). Cleared Jan 2020. https://www.510kdatabase.net/k193478/ 2020-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k193478-xtrac-momentum-excimer-laser-system-fda-510k.jpg K193478 - XTRAC Momentum Excimer Laser System K193478 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Strata Skin Sciences, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k191717/ 2020-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k191717-route-92-medical-sheath-system-fda-510k.jpg K191717 - Route 92 Medical Sheath System K191717 is a FDA 510(k) cleared neurology medical device. Manufacturer: Route 92 Medical, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k192409/ 2020-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k192409-midwest-rhino-xe-and-air-motor-m-fda-510k.jpg K192409 - Midwest Rhino XE and Air Motor M K192409 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona. Cleared Jan 2020. https://www.510kdatabase.net/k192544/ 2020-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k192544-erchonia-emerald-fda-510k.jpg K192544 - Erchonia Emerald K192544 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Erchonia Corporation. Cleared Jan 2020. https://www.510kdatabase.net/k193645/ 2020-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k193645-nva-nvp-and-nvt-fda-510k.jpg K193645 - nva, nvp, and nvt K193645 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nvision Biomedical Technologies, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k183074/ 2020-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k183074-tens-and-ems-stimulator-tens-stimulator-fda-510k.jpg K183074 - TENS and EMS Stimulator, TENS Stimulator K183074 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Astek Technology , Ltd.. Cleared Jan 2020. https://www.510kdatabase.net/k190878/ 2020-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k190878-trach-vac-endotracheal-tube-sftvpu-fda-510k.jpg K190878 - Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff, Trach- Vac Endotracheal Tube (SFTVVC) Subglottic Suction Tube with Salter Flex-Tip and Salter ThinCuff K190878 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Salter Labs, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k191221/ 2020-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k191221-cybird-led-curing-light-fda-510k.jpg K191221 - Cybird LED Curing Light K191221 is a FDA 510(k) cleared dental medical device. Manufacturer: Dxm Co., Ltd.. Cleared Jan 2020. https://www.510kdatabase.net/k191678/ 2020-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k191678-ip-converter-fda-510k.jpg K191678 - IP Converter K191678 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sony Electronics, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k191692/ 2020-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k191692-kardioscreen-fda-510k.jpg K191692 - KardioScreen K191692 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Imedrix Inc. (Formerly Piitech Inc.). Cleared Jan 2020. https://www.510kdatabase.net/k192307/ 2020-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k192307-nihon-kohden-nkv-550-series-ventilator-fda-510k.jpg K192307 - Nihon Kohden NKV-550 Series Ventilator System K192307 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Nihon Kohden Orangemed, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k192315/ 2020-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k192315-medline-green-ambidextrous-power-free-fda-510k.jpg K192315 - Medline Green Ambidextrous Power-Free Nitrile Examination Gloves with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs) K192315 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k192966/ 2020-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k192966-flowmet-fda-510k.jpg K192966 - FlowMet K192966 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Laser Associated Sciences, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k192995/ 2020-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k192995-osteoremedies-hip-spacer-system-fda-510k.jpg K192995 - OsteoRemedies Hip Spacer System K192995 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteoremedies, LLC. Cleared Jan 2020. https://www.510kdatabase.net/k193011/ 2020-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k193011-cd-horizon-fenestrated-screw-set-fda-510k.jpg K193011 - CD Horizon™ Fenestrated Screw Set K193011 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k193372/ 2020-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k193372-univers-revers-modular-glenoid-system-fda-510k.jpg K193372 - Univers Revers Modular Glenoid System (Augemented baseplates) K193372 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k193452/ 2020-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k193452-motoband-cp-implant-system-fda-510k.jpg K193452 - MotoBAND CP Implant System K193452 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Crossroads Extemity Systems, LLC. Cleared Jan 2020. https://www.510kdatabase.net/k193465/ 2020-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k193465-corticalink-spinal-fusion-platform-fda-510k.jpg K193465 - CorticaLINK Spinal Fusion Platform K193465 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spine Smith Holdings, LLC. Cleared Jan 2020. https://www.510kdatabase.net/k191052/ 2020-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k191052-hyalogyn-vaginal-moisturizing-fda-510k.jpg K191052 - HyaloGYN Vaginal Moisturizing Suppositories K191052 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Fidia Farmaceutici S.P.A.. Cleared Jan 2020. https://www.510kdatabase.net/k191210/ 2020-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k191210-longeviti-clearfit-cranial-implant-fda-510k.jpg K191210 - Longeviti ClearFit Cranial Implant K191210 is a FDA 510(k) cleared neurology medical device. Manufacturer: Longeviti Neuro Solutions, LLC. Cleared Jan 2020. https://www.510kdatabase.net/k192009/ 2020-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k192009-led-curing-light-fda-510k.jpg K192009 - LED Curing Light K192009 is a FDA 510(k) cleared dental medical device. Manufacturer: Ezgo Group, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k192363/ 2020-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k192363-altapore-fda-510k.jpg K192363 - Altapore K192363 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Baxter Healthcare Corporation. Cleared Jan 2020. https://www.510kdatabase.net/k192687/ 2020-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k192687-trelloss-l-mpf-fda-510k.jpg K192687 - TrellOss™-L MPF K192687 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nexxt Spine, LLC. Cleared Jan 2020. https://www.510kdatabase.net/k192975/ 2020-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k192975-tyber-medical-trauma-screws-fda-510k.jpg K192975 - Tyber Medical Trauma Screws K192975 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tyber Medical, LLC. Cleared Jan 2020. https://www.510kdatabase.net/k193433/ 2020-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k193433-amistem-c-fda-510k.jpg K193433 - AMIStem-C K193433 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Jan 2020. https://www.510kdatabase.net/k193440/ 2020-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k193440-er-reboa-plus-catheter-fda-510k.jpg K193440 - ER-REBOA PLUS Catheter K193440 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Prytime Medical Devices, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k191489/ 2020-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k191489-genesys-spine-3dp-cervical-interbody-fda-510k.jpg K191489 - Genesys Spine 3DP Cervical Interbody System K191489 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Genesys Spine. Cleared Jan 2020. https://www.510kdatabase.net/k191581/ 2020-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k191581-endoskeleton-tl-interbody-fusion-fda-510k.jpg K191581 - Endoskeleton TL Interbody Fusion Device, Endoskeleton TL Hyperlordotic Interbody Fusion Device K191581 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Titan Spine, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k192767/ 2020-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k192767-clear-aligner-fda-510k.jpg K192767 - Clear Aligner K192767 is a FDA 510(k) cleared dental medical device. Manufacturer: Royal Dental Lab. Cleared Jan 2020. https://www.510kdatabase.net/k192974/ 2020-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k192974-tyber-medical-trauma-screw-fda-510k.jpg K192974 - Tyber Medical Trauma Screw K192974 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tyber Medical, LLC. Cleared Jan 2020. https://www.510kdatabase.net/k193024/ 2020-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k193024-sensititre-20-24-hour-haemophilus-fda-510k.jpg K193024 - Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint, Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/mL K193024 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Thermo Fisher Scientific. Cleared Jan 2020. https://www.510kdatabase.net/k193137/ 2020-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k193137-easygrip-flo-41-precision-mis-delivery-fda-510k.jpg K193137 - EASYGRIP FLO-41 Precision MIS Delivery System K193137 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Baxter Healthcare Corportation. Cleared Jan 2020. https://www.510kdatabase.net/k190651/ 2020-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k190651-erbecryo-2-cryosurgical-unit-fda-510k.jpg K190651 - ERBECRYO 2 Cryosurgical Unit K190651 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Erbe Elektromedizin GmbH. Cleared Jan 2020. https://www.510kdatabase.net/k190942/ 2020-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k190942-disposable-powder-free-nitrile-fda-510k.jpg K190942 - Disposable Powder Free Nitrile Examination Glove, Pink/Black Color K190942 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ever Growth (Vietnam) Co. , Ltd.. Cleared Jan 2020. https://www.510kdatabase.net/k191870/ 2020-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k191870-vv330-continuous-ecg-platform-vivalnk-fda-510k.jpg K191870 - VV330 Continuous ECG Platform, VivaLNK Adhesive Patch K191870 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: VivaLNK, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k192715/ 2020-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k192715-crf-radiofrequency-ablation-system-fda-510k.jpg K192715 - CRF Radiofrequency Ablation System K192715 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cambridge Interventional, LLC. Cleared Jan 2020. https://www.510kdatabase.net/k192754/ 2020-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k192754-avenger-radial-head-system-fda-510k.jpg K192754 - Avenger Radial Head System K192754 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: In2bones USA, LLC. Cleared Jan 2020. https://www.510kdatabase.net/k192774/ 2020-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k192774-biocardia-8f-morph-dna-deflectable-fda-510k.jpg K192774 - BioCardia 8F Morph DNA Deflectable Guide Catheter K192774 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biocardia. Cleared Jan 2020. https://www.510kdatabase.net/k191123/ 2020-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k191123-multi-unit-abutments-fda-510k.jpg K191123 - Multi-unit Abutments K191123 is a FDA 510(k) cleared dental medical device. Manufacturer: Medentika GmbH. Cleared Jan 2020. https://www.510kdatabase.net/k191642/ 2020-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k191642-tk-sterile-piston-syringe-without-needle-fda-510k.jpg K191642 - TK Sterile Piston Syringe without Needle K191642 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Anhui Tiankang Medical Technology Co., Ltd.. Cleared Jan 2020. https://www.510kdatabase.net/k192412/ 2020-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k192412-sd500-elite-lubefree-high-speed-fda-510k.jpg K192412 - SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece K192412 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentalez, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k192497/ 2020-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k192497-evol-ha-d-lateral-interbody-fusion-fda-510k.jpg K192497 - EVOL ha - D Lateral Interbody Fusion System K192497 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Cutting Edge Spine, LLC. Cleared Jan 2020. https://www.510kdatabase.net/k192827/ 2020-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k192827-quadra-p-fda-510k.jpg K192827 - Quadra-P K192827 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Jan 2020. https://www.510kdatabase.net/k192903/ 2020-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k192903-rs85-diagnostic-ultrasound-system-fda-510k.jpg K192903 - RS85 Diagnostic Ultrasound System K192903 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Medison Co., Ltd.. Cleared Jan 2020. https://www.510kdatabase.net/k192917/ 2020-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k192917-viewpoint-6-fda-510k.jpg K192917 - ViewPoint 6 K192917 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems Ultrasound And. Cleared Jan 2020. https://www.510kdatabase.net/k193102/ 2020-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k193102-mriaudio-prem-system-with-mriview-fda-510k.jpg K193102 - MRIaudio PREM System with MRIview K193102 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mriaudio, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k193125/ 2020-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k193125-r2p-destination-slender-guiding-sheath-fda-510k.jpg K193125 - R2P Destination Slender Guiding Sheath K193125 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corporation. Cleared Jan 2020. https://www.510kdatabase.net/k192696/ 2020-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k192696-trimed-aset-foot-plating-system-fda-510k.jpg K192696 - TriMed ASET Foot Plating System K192696 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: TriMed, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k181546/ 2020-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k181546-dillard-nasal-balloon-catheter-fda-510k.jpg K181546 - Dillard Nasal Balloon Catheter K181546 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Intuit Medical Products, LLC. Cleared Jan 2020. https://www.510kdatabase.net/k190243/ 2020-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k190243-z5-bl-fda-510k.jpg K190243 - Z5-BL K190243 is a FDA 510(k) cleared dental medical device. Manufacturer: Z-Systems AG. Cleared Jan 2020. https://www.510kdatabase.net/k190669/ 2020-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k190669-endotics-fda-510k.jpg K190669 - Endotics K190669 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Era Endoscopy S.R.L.. Cleared Jan 2020. https://www.510kdatabase.net/k191056/ 2020-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k191056-conformity-stem-cemented-fda-510k.jpg K191056 - Conformity stem, cemented K191056 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: United Orthopedic Corporation. Cleared Jan 2020. https://www.510kdatabase.net/k191195/ 2020-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k191195-piccguard-fda-510k.jpg K191195 - PiccGuard K191195 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Piccguard, LLC. Cleared Jan 2020. https://www.510kdatabase.net/k191501/ 2020-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k191501-pallas-308311-solid-state-uv-laser-fda-510k.jpg K191501 - PALLAS 308/311 Solid-State UV Laser System K191501 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Laseroptek Co., Ltd.. Cleared Jan 2020. https://www.510kdatabase.net/k192893/ 2020-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k192893-straumann-ceramic-healing-abutments-fda-510k.jpg K192893 - Straumann Ceramic Healing Abutments K192893 is a FDA 510(k) cleared dental medical device. Manufacturer: Institut Straumann AG. Cleared Jan 2020. https://www.510kdatabase.net/k193140/ 2020-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k193140-flex-body-speeder-fda-510k.jpg K193140 - Flex Body SPEEDER K193140 is a FDA 510(k) cleared radiology medical device. Manufacturer: Quality Electrodynamics, LLC. Cleared Jan 2020. https://www.510kdatabase.net/k193239/ 2020-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k193239-mpowrx-snoring-solution-also-known-as-fda-510k.jpg K193239 - MPowRx Snoring Solution (also known as Good Morning Snore Solution) K193239 is a FDA 510(k) cleared dental medical device. Manufacturer: Mpowrx Health and Wellness Products 2012, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k193359/ 2020-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k193359-suremax-family-of-cervical-spacers-fda-510k.jpg K193359 - SureMAX Family of Cervical Spacers K193359 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Additive Implants, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k193375/ 2020-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k193375-neuroblate-system-fda-510k.jpg K193375 - NeuroBlate System K193375 is a FDA 510(k) cleared neurology medical device. Manufacturer: Monteris Medical,. Cleared Jan 2020. https://www.510kdatabase.net/k193431/ 2020-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k193431-alignrt-plus-fda-510k.jpg K193431 - AlignRT Plus K193431 is a FDA 510(k) cleared radiology medical device. Manufacturer: Vision Rt, Ltd.. Cleared Jan 2020. https://www.510kdatabase.net/k183089/ 2020-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k183089-air-next-fda-510k.jpg K183089 - Air Next K183089 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Nuvoair AB. Cleared Jan 2020. https://www.510kdatabase.net/k191061/ 2020-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k191061-optilume-basic-urological-balloon-fda-510k.jpg K191061 - Optilume Basic Urological Balloon Dilation Catheter K191061 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Urotronic, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k191147/ 2020-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k191147-oc-auto-sensor-io-ifob-test-fda-510k.jpg K191147 - OC-Auto SENSOR io iFOB Test K191147 is a FDA 510(k) cleared hematology medical device. Manufacturer: Eiken Chemical Co., Ltd.. Cleared Jan 2020. https://www.510kdatabase.net/k191446/ 2020-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k191446-ureteral-stent-systems-biliary-fda-510k.jpg K191446 - Ureteral Stent Systems, Biliary Drainage Catheters K191446 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Jan 2020. https://www.510kdatabase.net/k191739/ 2020-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k191739-sterile-leadconfirm-fda-510k.jpg K191739 - Sterile LeadConfirm K191739 is a FDA 510(k) cleared neurology medical device. Manufacturer: Alpha Omega Engineering , Ltd.. Cleared Jan 2020. https://www.510kdatabase.net/k191907/ 2020-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k191907-optowire-iii-fda-510k.jpg K191907 - OptoWire III K191907 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Opsens, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k192216/ 2020-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k192216-invacare-aviva-fx-power-wheelchair-fda-510k.jpg K192216 - Invacare AVIVA FX Power Wheelchair, Model: IFX-20MP K192216 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Invacare Corporation. Cleared Jan 2020. https://www.510kdatabase.net/k192457/ 2020-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k192457-elos-accurate-customized-abutment-fda-510k.jpg K192457 - Elos Accurate Customized Abutment K192457 is a FDA 510(k) cleared dental medical device. Manufacturer: Elos Medtech Pinol A/S. Cleared Jan 2020. https://www.510kdatabase.net/k192599/ 2020-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k192599-asahi-ptca-guide-wire-asahi-gaia-next-fda-510k.jpg K192599 - ASAHI PTCA Guide Wire ASAHI Gaia Next K192599 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Asahi Intecc Co., Ltd.. Cleared Jan 2020. https://www.510kdatabase.net/k193092/ 2020-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k193092-tunneloc-tibial-fixation-device-fda-510k.jpg K193092 - TunneLoc Tibial Fixation Device K193092 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jan 2020. https://www.510kdatabase.net/k193360/ 2020-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k193360-acuity-sdr-standard-acuity-sdr-plus-fda-510k.jpg K193360 - Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard K193360 is a FDA 510(k) cleared radiology medical device. Manufacturer: Radmedix, LLC. Cleared Jan 2020. https://www.510kdatabase.net/k190990/ 2019-12-31 monthly 0.5 https://www.510kdatabase.net/og-image/k190990-digital-thermometer-fda-510k.jpg K190990 - Digital Thermometer K190990 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Xiamen Ants Bro Technology Co., Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k192343/ 2019-12-31 monthly 0.5 https://www.510kdatabase.net/og-image/k192343-patient-monitor-fda-510k.jpg K192343 - Patient Monitor K192343 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Creative Industry Co., Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k192444/ 2019-12-31 monthly 0.5 https://www.510kdatabase.net/og-image/k192444-mcare-powder-free-nitrile-black-fda-510k.jpg K192444 - mCare® Powder Free Nitrile Black Examination Glove K192444 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Mercator Medical (Thailand), Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k192578/ 2019-12-31 monthly 0.5 https://www.510kdatabase.net/og-image/k192578-incore-tmt-system-fda-510k.jpg K192578 - InCore TMT System K192578 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nextremity Solutions, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k192912/ 2019-12-31 monthly 0.5 https://www.510kdatabase.net/og-image/k192912-automistar-fda-510k.jpg K192912 - AutoMIStar K192912 is a FDA 510(k) cleared radiology medical device. Manufacturer: Apollo Medical Imaging Technology Pty. , Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k193381/ 2019-12-31 monthly 0.5 https://www.510kdatabase.net/og-image/k193381-radcalc-software-fda-510k.jpg K193381 - RadCalc Software K193381 is a FDA 510(k) cleared radiology medical device. Manufacturer: Lifeline Software, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k190241/ 2019-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k190241-sterile-latex-surgical-glove-powder-free-fda-510k.jpg K190241 - Sterile Latex Surgical Glove, Powder Free K190241 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Careglove Global Sdn. Bhd.. Cleared Dec 2019. https://www.510kdatabase.net/k192258/ 2019-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k192258-disposable-valve-sets-fda-510k.jpg K192258 - Disposable Valve Sets K192258 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Zhejiang Chuangxiang Medical Technology Co., Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k192655/ 2019-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k192655-depuy-synthes-maxillofacial-portfolio-fda-510k.jpg K192655 - Depuy Synthes Maxillofacial Portfolio - MR Conditional K192655 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes USA Products, LLC. Cleared Dec 2019. https://www.510kdatabase.net/k191059/ 2019-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k191059-masimo-rad-97-and-accessories-fda-510k.jpg K191059 - Masimo Rad-97 and Accessories K191059 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Masimo Corporation. Cleared Dec 2019. https://www.510kdatabase.net/k191256/ 2019-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k191256-straumann-blx-35-mm-implants-fda-510k.jpg K191256 - Straumann BLX Ø3.5 mm Implants K191256 is a FDA 510(k) cleared dental medical device. Manufacturer: Institut Straumann AG. Cleared Dec 2019. https://www.510kdatabase.net/k191696/ 2019-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k191696-biodesign-anal-fistula-plug-biodesign-fda-510k.jpg K191696 - Biodesign Anal Fistula Plug, Biodesign Fistula Plug, Biodesign Plastic Surgery Matrix, Biodesign Tissue Graft K191696 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cook Biotech Incorporated. Cleared Dec 2019. https://www.510kdatabase.net/k192196/ 2019-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k192196-medical-radiation-dosimetry-system-fda-510k.jpg K192196 - Medical Radiation Dosimetry System microSTARii K192196 is a FDA 510(k) cleared radiology medical device. Manufacturer: Landauer. Cleared Dec 2019. https://www.510kdatabase.net/k192695/ 2019-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k192695-inmode-system-with-the-morpheus8-fda-510k.jpg K192695 - InMode System with the Morpheus8 (Fractora) Applicators K192695 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Inmode MD , Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k192700/ 2019-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k192700-xcam-fda-510k.jpg K192700 - Xcam K192700 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hdx Will Corp.. Cleared Dec 2019. https://www.510kdatabase.net/k192939/ 2019-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k192939-volumetric-specimen-imager-fda-510k.jpg K192939 - Volumetric Specimen Imager K192939 is a FDA 510(k) cleared radiology medical device. Manufacturer: Clarix Imaging. Cleared Dec 2019. https://www.510kdatabase.net/k193149/ 2019-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k193149-true-3d-viewer-software-fda-510k.jpg K193149 - True 3D Viewer Software K193149 is a FDA 510(k) cleared radiology medical device. Manufacturer: Echopixel, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k193403/ 2019-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k193403-uronav-system-fda-510k.jpg K193403 - UroNav System K193403 is a FDA 510(k) cleared radiology medical device. Manufacturer: Invivo Corporation. Cleared Dec 2019. https://www.510kdatabase.net/k190467/ 2019-12-26 monthly 0.5 https://www.510kdatabase.net/og-image/k190467-ihelmet-hair-growth-system-fda-510k.jpg K190467 - iHelmet Hair Growth System K190467 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Slinph Technologies Co., Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k190884/ 2019-12-26 monthly 0.5 https://www.510kdatabase.net/og-image/k190884-tigerpaw-pro-left-atrial-appendage-fda-510k.jpg K190884 - TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery Tool K190884 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Datascope Corp.. Cleared Dec 2019. https://www.510kdatabase.net/k192768/ 2019-12-26 monthly 0.5 https://www.510kdatabase.net/og-image/k192768-temporary-fixation-pins-fda-510k.jpg K192768 - Temporary Fixation Pins K192768 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Eisertech, LLC. Cleared Dec 2019. https://www.510kdatabase.net/k193050/ 2019-12-26 monthly 0.5 https://www.510kdatabase.net/og-image/k193050-alloclassic-zweymuller-sl-femoral-stem-fda-510k.jpg K193050 - Alloclassic Zweymuller SL Femoral Stem, Alloclassic Zweymuller SL Offset Femoral Stem K193050 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer GmbH. Cleared Dec 2019. https://www.510kdatabase.net/k192135/ 2019-12-24 monthly 0.5 https://www.510kdatabase.net/og-image/k192135-via-microcatheter-size-17-via-fda-510k.jpg K192135 - VIA Microcatheter (size 17), VIA Microcatheter (size 21), VIA Microcatheter (size 27), VIA Microcatheter (size 33) K192135 is a FDA 510(k) cleared neurology medical device. Manufacturer: MicroVention, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k182718/ 2019-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k182718-mini-and-micro-fragments-fda-510k.jpg K182718 - Mini and Micro Fragments Reconstruction System – GMReis K182718 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Gm Dos Reis Industria E Comerico Ltda.. Cleared Dec 2019. https://www.510kdatabase.net/k190665/ 2019-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k190665-neodent-instrument-kit-cases-fda-510k.jpg K190665 - Neodent Instrument Kit Cases K190665 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jjgc Industria E Comercio DE Materiais Dentarios S.A.. Cleared Dec 2019. https://www.510kdatabase.net/k190736/ 2019-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k190736-disposable-powder-free-nitrile-fda-510k.jpg K190736 - Disposable Powder Free Nitrile Examination Glove,Blue Color, Tested For Use With Chemotherapy Drugs K190736 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ever Growth (Vietnam) Co. , Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k190860/ 2019-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k190860-disposable-powder-free-nitrile-fda-510k.jpg K190860 - Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, White color, Disposable Powder Free Nitrile Examination Glove, Tested For Use With Chemotherapy Drugs, Orange color K190860 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ever Growth (Vietnam) Co. , Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k191551/ 2019-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k191551-rist-cath-radial-access-long-sheath-fda-510k.jpg K191551 - RIST Cath Radial Access Long Sheath K191551 is a FDA 510(k) cleared neurology medical device. Manufacturer: Rist Neurovascular, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k191846/ 2019-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k191846-maxreach-laser-probe-fda-510k.jpg K191846 - MAXReach Laser Probe K191846 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Vortex Surgical, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k191960/ 2019-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k191960-arthrex-univers-revers-modular-glenoid-fda-510k.jpg K191960 - Arthrex Univers Revers Modular Glenoid System K191960 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k192023/ 2019-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k192023-arm-blood-pressure-monitor-fda-510k.jpg K192023 - Arm Blood Pressure Monitor K192023 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Truly Instrument Limited. Cleared Dec 2019. https://www.510kdatabase.net/k192104/ 2019-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k192104-medline-sterile-power-free-nitrile-fda-510k.jpg K192104 - Medline Sterile Power-Free Nitrile Examination Gloves - Blue (Test for Use with Chemotherapy Drugs) K192104 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k192485/ 2019-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k192485-biocode-respiratory-pathogen-panel-rpp-fda-510k.jpg K192485 - BioCode Respiratory Pathogen Panel (RPP) K192485 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Applied BioCode, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k192487/ 2019-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k192487-ez-trax-containment-device-fda-510k.jpg K192487 - EZ-TRAX Containment Device K192487 is a FDA 510(k) cleared general hospital medical device. Manufacturer: K1 Medical, LLC. Cleared Dec 2019. https://www.510kdatabase.net/k192645/ 2019-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k192645-trigon-ti-stand-alone-wedge-fixation-fda-510k.jpg K192645 - Trigon™ Ti Stand-Alone Wedge Fixation System K192645 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nvision Biomedical Technologies, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k192733/ 2019-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k192733-relieforme-tensems-device-model-upk-ge01-fda-510k.jpg K192733 - RelieforMe TENS/EMS Device Model UPK-GE01 K192733 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Umeheal , Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k193254/ 2019-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k193254-3m-attest-steam-chemical-integrator-fda-510k.jpg K193254 - 3M Attest Steam Chemical Integrator K193254 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Dec 2019. https://www.510kdatabase.net/k193279/ 2019-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k193279-comet-ii-pressure-guidewire-fda-510k.jpg K193279 - Comet II Pressure Guidewire K193279 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Dec 2019. https://www.510kdatabase.net/den180067/ 2019-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/den180067-mucosal-integrity-conductivity-mi-test-fda-510k.jpg DEN180067 - Mucosal Integrity Conductivity (MI) Test System DEN180067 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Diversatek Healthcare, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k192559/ 2019-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k192559-acetabular-bone-screws-for-mobilelink-fda-510k.jpg K192559 - Acetabular Bone Screws (for MobileLink Acetabular Cup System) K192559 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Waldemar Link GmbH & Co. KG. Cleared Dec 2019. https://www.510kdatabase.net/k192629/ 2019-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k192629-spinalytics-fda-510k.jpg K192629 - Spinalytics K192629 is a FDA 510(k) cleared neurology medical device. Manufacturer: Optima Health Solutions International Corp.. Cleared Dec 2019. https://www.510kdatabase.net/k183213/ 2019-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k183213-icesense-3-prosense-multisense-fda-510k.jpg K183213 - IceSense 3, ProSense, MultiSense K183213 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: IceCure Medical , Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k190008/ 2019-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k190008-carescape-one-fda-510k.jpg K190008 - Carescape One K190008 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Healthcare. Cleared Dec 2019. https://www.510kdatabase.net/k190112/ 2019-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k190112-non-sterile-zirconia-block-fda-510k.jpg K190112 - Non-Sterile Zirconia Block K190112 is a FDA 510(k) cleared dental medical device. Manufacturer: Fine Advanced Compound Co., Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k190284/ 2019-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k190284-bengal-stackable-cage-system-fda-510k.jpg K190284 - Bengal Stackable Cage System K190284 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International SARL. Cleared Dec 2019. https://www.510kdatabase.net/k190633/ 2019-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k190633-nanoortho-nanoknee-system-fda-510k.jpg K190633 - NanoOrtho NanoKnee® System K190633 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nanoortho, LLC. Cleared Dec 2019. https://www.510kdatabase.net/k190730/ 2019-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k190730-iodosorb-fda-510k.jpg K190730 - IODOSORB K190730 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew Medical, Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k190756/ 2019-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k190756-iodoflex-fda-510k.jpg K190756 - IODOFLEX K190756 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew Medical, Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k190805/ 2019-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k190805-pentax-medical-video-processor-epk-fda-510k.jpg K190805 - PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL K190805 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Pentax of America, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k190929/ 2019-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k190929-xvision-spine-system-xvs-fda-510k.jpg K190929 - xvision Spine system (XVS) K190929 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Augmedics, Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k191234/ 2019-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k191234-apc-3-argon-plasma-coagulation-unit-fda-510k.jpg K191234 - APC 3 Argon Plasma Coagulation Unit, VIO 3 Electrosurgical Unit, FiAPC probes, Hybrid APC, APCapplicators, APC Pressure Reducer with Sensor, VIO Cart, Fastening sets K191234 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Erbe Elektromedizin GmbH. Cleared Dec 2019. https://www.510kdatabase.net/k191350/ 2019-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k191350-active-free-testosterone-ria-fda-510k.jpg K191350 - ACTIVE® Free Testosterone RIA K191350 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Immunotech S.R.O.. Cleared Dec 2019. https://www.510kdatabase.net/k191403/ 2019-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k191403-pulse-oximeter-fda-510k.jpg K191403 - Pulse Oximeter K191403 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Nonin Medical, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k191440/ 2019-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k191440-paragonix-sherpapak-pancreas-transport-fda-510k.jpg K191440 - Paragonix SherpaPak Pancreas Transport System K191440 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Paragonix Technologies. Cleared Dec 2019. https://www.510kdatabase.net/k191647/ 2019-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k191647-qlab-advanced-quantification-software-fda-510k.jpg K191647 - QLAB Advanced Quantification Software K191647 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Health Care. Cleared Dec 2019. https://www.510kdatabase.net/k191666/ 2019-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k191666-unscented-w-long-plastic-and-cardboard-fda-510k.jpg K191666 - Unscented W long plastic and cardboard applicator tampons K191666 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ontex Bvba. Cleared Dec 2019. https://www.510kdatabase.net/k191823/ 2019-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k191823-clear-aligners-fda-510k.jpg K191823 - Clear-Aligners K191823 is a FDA 510(k) cleared dental medical device. Manufacturer: Cdb Corporation. Cleared Dec 2019. https://www.510kdatabase.net/k191836/ 2019-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k191836-ceramill-a-splint-fda-510k.jpg K191836 - Ceramill A-Splint K191836 is a FDA 510(k) cleared dental medical device. Manufacturer: Amann Girrbach AG. Cleared Dec 2019. https://www.510kdatabase.net/k191879/ 2019-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k191879-drx-evolution-with-carestream-digital-fda-510k.jpg K191879 - DRX-Evolution with Carestream Digital Tomosynthesis K191879 is a FDA 510(k) cleared radiology medical device. Manufacturer: Carestream Health, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k191967/ 2019-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k191967-unyvero-lrt-bal-application-fda-510k.jpg K191967 - Unyvero LRT BAL Application K191967 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Curetis GmbH. Cleared Dec 2019. https://www.510kdatabase.net/k192027/ 2019-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k192027-werewolf-coblation-system-coblation-fda-510k.jpg K192027 - WEREWOLF COBLATION System, COBLATION HALO Wand K192027 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: ArthroCare Corporation. Cleared Dec 2019. https://www.510kdatabase.net/k192040/ 2019-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k192040-aview-modeler-fda-510k.jpg K192040 - AVIEW Modeler K192040 is a FDA 510(k) cleared radiology medical device. Manufacturer: Coreline Soft Co., Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k192178/ 2019-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k192178-rd-series-nova-compo-n-fda-510k.jpg K192178 - R&D Series Nova Compo N K192178 is a FDA 510(k) cleared dental medical device. Manufacturer: Imicryl Dis Malzemeleri Sanayi VE Ticaret AS. Cleared Dec 2019. https://www.510kdatabase.net/k192383/ 2019-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k192383-briefcase-fda-510k.jpg K192383 - BriefCase K192383 is a FDA 510(k) cleared radiology medical device. Manufacturer: Aidoc Medical , Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k192470/ 2019-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k192470-denmat-orthodontic-aligners-fda-510k.jpg K192470 - DenMat Orthodontic Aligners K192470 is a FDA 510(k) cleared dental medical device. Manufacturer: Denmat Holdings, LLC. Cleared Dec 2019. https://www.510kdatabase.net/k192471/ 2019-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k192471-rhin1-stylus-fda-510k.jpg K192471 - RHIN1 Stylus K192471 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Aerin Medical, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k192711/ 2019-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k192711-dannik-titanium-ligation-clip-fda-510k.jpg K192711 - Dannik Titanium Ligation Clip K192711 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Dannik. Cleared Dec 2019. https://www.510kdatabase.net/k192718/ 2019-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k192718-fortilink-interbody-fusion-device-ibf-fda-510k.jpg K192718 - Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology K192718 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.). Cleared Dec 2019. https://www.510kdatabase.net/k192755/ 2019-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k192755-soli-lite-lg4-galileo-fda-510k.jpg K192755 - Soli-Lite LG4 Galileo K192755 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Silhouet-Tone Corporation. Cleared Dec 2019. https://www.510kdatabase.net/k192833/ 2019-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k192833-indigo-aspiration-system-fda-510k.jpg K192833 - Indigo Aspiration System K192833 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Penumbra, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k192873/ 2019-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k192873-sx-one-microknife-fda-510k.jpg K192873 - SX-One MicroKnife K192873 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Sonex Health, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k192990/ 2019-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k192990-litho-evo-fda-510k.jpg K192990 - Litho Evo K192990 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Quanta System Spa. Cleared Dec 2019. https://www.510kdatabase.net/k193018/ 2019-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k193018-surgical-direct-hand-held-laparoscopic-fda-510k.jpg K193018 - Surgical Direct Hand-held Laparoscopic Instruments K193018 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Surgical Direct, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k193116/ 2019-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k193116-mropen-evo-fda-510k.jpg K193116 - MRopen EVO K193116 is a FDA 510(k) cleared radiology medical device. Manufacturer: Asg Superconductors S.P.A.. Cleared Dec 2019. https://www.510kdatabase.net/k193230/ 2019-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k193230-ziehm-vision-fd-fda-510k.jpg K193230 - Ziehm Vision FD K193230 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ziehm Imaging GmbH. Cleared Dec 2019. https://www.510kdatabase.net/k193235/ 2019-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k193235-telepack-fda-510k.jpg K193235 - Telepack + K193235 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k193238/ 2019-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k193238-nexus-dr-digital-x-ray-imaging-system-fda-510k.jpg K193238 - Nexus DR Digital X-Ray Imaging System (with vSharp) K193238 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varex Imaging Corporation. Cleared Dec 2019. https://www.510kdatabase.net/k193269/ 2019-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k193269-urolift-system-ul400-fda-510k.jpg K193269 - UroLift System (UL400) K193269 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Neotract, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k193292/ 2019-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k193292-voyant-5mm-fusion-device-voyant-fda-510k.jpg K193292 - Voyant 5mm Fusion Device, Voyant Maryland Fusion Device K193292 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Applied Medical Resources Corp.. Cleared Dec 2019. https://www.510kdatabase.net/k182388/ 2019-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k182388-krystal-klear-aligners-fda-510k.jpg K182388 - Krystal Klear Aligners K182388 is a FDA 510(k) cleared dental medical device. Manufacturer: Shatkin F.I.R.S.T., LLC. Cleared Dec 2019. https://www.510kdatabase.net/k183144/ 2019-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k183144-umc-560i-fda-510k.jpg K183144 - uMC 560i K183144 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k183676/ 2019-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k183676-dentiqair-fda-510k.jpg K183676 - DentiqAir K183676 is a FDA 510(k) cleared radiology medical device. Manufacturer: 3D Industrial Imaging Co., Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k190775/ 2019-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k190775-the-rhea-vital-sign-vigilance-system-fda-510k.jpg K190775 - The RHEA Vital Sign Vigilance System K190775 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Fiber Medical Technology Co. , Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k190829/ 2019-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k190829-gastrointestinal-injection-needles-vin-fda-510k.jpg K190829 - Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI) K190829 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Wilson-Cook Medical Inc./Cook Endoscopy. Cleared Dec 2019. https://www.510kdatabase.net/k190881/ 2019-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k190881-spinal-elements-navigated-instruments-fda-510k.jpg K190881 - Spinal Elements Navigated Instruments K190881 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinal Elements, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k190935/ 2019-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k190935-ezer-portable-x-ray-system-fda-510k.jpg K190935 - EZER, Portable X-ray System K190935 is a FDA 510(k) cleared radiology medical device. Manufacturer: Livermoretech, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k190939/ 2019-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k190939-zoll-arrhythmia-management-sysyem-fda-510k.jpg K190939 - ZOLL Arrhythmia Management Sysyem K190939 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Zoll Manufacturing Corporation. Cleared Dec 2019. https://www.510kdatabase.net/k191305/ 2019-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k191305-hereaeus-poseidon-microcatheter-fda-510k.jpg K191305 - Hereaeus Poseidon Microcatheter K191305 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Heraeus Medical Components, LLC. Cleared Dec 2019. https://www.510kdatabase.net/k191314/ 2019-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k191314-sunkingdom-applanation-tonometer-sk-r-fda-510k.jpg K191314 - Sunkingdom Applanation Tonometer SK-R, SK-T, SK-Q K191314 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Chongqing Sunkingdom Medical Instrument Co., Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k191643/ 2019-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k191643-tk-sterile-hypodermic-needle-fda-510k.jpg K191643 - TK Sterile Hypodermic Needle K191643 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Anhui Tiankang Medical Technology Co., Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k192044/ 2019-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k192044-4cis-marlin-peek-acif-cage-fda-510k.jpg K192044 - 4CIS Marlin PEEK ACIF Cage K192044 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Solco Biomedical Co., Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k192100/ 2019-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k192100-aveta-disposable-hysteroscope-fda-510k.jpg K192100 - Aveta Disposable Hysteroscope K192100 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Meditrina, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k192229/ 2019-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k192229-neodent-implant-system-gm-titanium-fda-510k.jpg K192229 - Neodent Implant System- GM Titanium Base for Bridge K192229 is a FDA 510(k) cleared dental medical device. Manufacturer: Jjgc Industria E Comercio DE Materiais Dentarios S.A.. Cleared Dec 2019. https://www.510kdatabase.net/k192313/ 2019-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k192313-halo-one-thin-walled-guiding-sheath-fda-510k.jpg K192313 - Halo One Thin-Walled Guiding Sheath K192313 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k192410/ 2019-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k192410-zs3-and-zone-pro-ultrasound-systems-fda-510k.jpg K192410 - ZS3 and z.one pro Ultrasound Systems K192410 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k192589/ 2019-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k192589-everyway-otc-tensems-combination-fda-510k.jpg K192589 - Everyway OTC TENS/EMS Combination K192589 is a FDA 510(k) cleared neurology medical device. Manufacturer: Everyway Medical Instruments Co.,Ltd. Cleared Dec 2019. https://www.510kdatabase.net/k192607/ 2019-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k192607-litewalk-fda-510k.jpg K192607 - LiteWalk K192607 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Viasonix , Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k193001/ 2019-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k193001-albumin-bcp-fda-510k.jpg K193001 - Albumin BCP K193001 is a FDA 510(k) cleared chemistry medical device. Manufacturer: SENTINEL CH. SpA. Cleared Dec 2019. https://www.510kdatabase.net/k193004/ 2019-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k193004-monopolar-cord-fda-510k.jpg K193004 - Monopolar Cord K193004 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: New Deantronics Taiwan , Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k182476/ 2019-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k182476-disposable-powered-articulating-fda-510k.jpg K182476 - Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads K182476 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Fengh Medical Co., Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k190012/ 2019-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k190012-omni-stat-vascular-rapid-fda-510k.jpg K190012 - OMNI-STAT Vascular (Rapid) K190012 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medtrade Product, Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k190824/ 2019-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k190824-airway-gas-sampling-set-disposable-fda-510k.jpg K190824 - Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 3m/10ft, Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 2m/7ft, Airway Gas Sampling Set, disposable, Infant, TPE, 2m/7ft, Airway Adapter with Luer Connector, Adult/Pediatric K190824 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Bluepoint Medical GmbH & Co. KG. Cleared Dec 2019. https://www.510kdatabase.net/k191087/ 2019-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k191087-intramarx-radiopaque-markers-fda-510k.jpg K191087 - IntraMarX Radiopaque Markers K191087 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Anx Robotica Corp. Cleared Dec 2019. https://www.510kdatabase.net/k191614/ 2019-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k191614-biosticker-system-fda-510k.jpg K191614 - BioSticker System K191614 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biointellisense, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k191667/ 2019-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k191667-electronic-stethoscope-fda-510k.jpg K191667 - Electronic Stethoscope K191667 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hefei Mintti Medical Technology Co., Ltd. China. Cleared Dec 2019. https://www.510kdatabase.net/k191898/ 2019-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k191898-sterile-latex-powder-free-surgical-fda-510k.jpg K191898 - Sterile Latex Powder-Free Surgical Gloves K191898 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Modern Healthcare Corp.. Cleared Dec 2019. https://www.510kdatabase.net/k192189/ 2019-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k192189-avenir-complete-hip-system-size-0-coxa-fda-510k.jpg K192189 - Avenir Complete Hip System, Size 0 Coxa Vara K192189 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k192580/ 2019-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k192580-stratafix-spiral-monocryl-plus-fda-510k.jpg K192580 - STRATAFIX Spiral Monocryl, Plus Bidirectional Knotless Tissue Control Device K192580 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k192584/ 2019-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k192584-beacon-caresystem-model-00002144-fda-510k.jpg K192584 - BEACON Caresystem Model 00002144 K192584 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Mermaid Care A/S. Cleared Dec 2019. https://www.510kdatabase.net/k192670/ 2019-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k192670-neodent-instrument-kit-cases-fda-510k.jpg K192670 - Neodent Instrument Kit Cases K192670 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jjgc Industria E Comercio DE Materiais Dentarios S.A.. Cleared Dec 2019. https://www.510kdatabase.net/k192680/ 2019-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k192680-percusys-plus-pedicle-screw-system-fda-510k.jpg K192680 - Percusys® Plus Pedicle Screw System K192680 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Joimax GmbH. Cleared Dec 2019. https://www.510kdatabase.net/k190725/ 2019-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k190725-nitrile-examination-glove-sterile-fda-510k.jpg K190725 - Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White K190725 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Riverstone Resources Sdn Bhd. Cleared Dec 2019. https://www.510kdatabase.net/k191758/ 2019-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k191758-single-loop-snare-retrieval-kit-triple-fda-510k.jpg K191758 - Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit K191758 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Argon Medical Devices, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k192249/ 2019-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k192249-inmode-system-with-tone-applicator-fda-510k.jpg K192249 - InMode System with Tone Applicator K192249 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Inmode , Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k192267/ 2019-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k192267-ilumien-system-with-aptivue-software-fda-510k.jpg K192267 - ILUMIEN System with AptiVue Software version D.3 K192267 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared Dec 2019. https://www.510kdatabase.net/k192450/ 2019-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k192450-precision-casting-solutions-total-hip-fda-510k.jpg K192450 - Precision Casting Solutions Total Hip System K192450 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Precision Casting Solution, LLC. Cleared Dec 2019. https://www.510kdatabase.net/k192572/ 2019-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k192572-cns-envision-fda-510k.jpg K192572 - CNS Envision K192572 is a FDA 510(k) cleared neurology medical device. Manufacturer: Moberg Research, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k192595/ 2019-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k192595-exspiron-2xi-fda-510k.jpg K192595 - ExSpiron 2Xi K192595 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respiratory Motion. Cleared Dec 2019. https://www.510kdatabase.net/k192615/ 2019-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k192615-peri-strips-dry-with-veritas-collagen-fda-510k.jpg K192615 - Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Technology (PSDV-SG) K192615 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Synovis Life Technologies, Inc. (Baxter International Inc.). Cleared Dec 2019. https://www.510kdatabase.net/k192763/ 2019-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k192763-syngoct-cascoring-fda-510k.jpg K192763 - syngo.CT CaScoring K192763 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k193039/ 2019-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k193039-single-use-balloon-dilator-v-with-knife-fda-510k.jpg K193039 - Single Use Balloon Dilator V (with knife) K193039 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Dec 2019. https://www.510kdatabase.net/k193071/ 2019-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k193071-bashir-plus-endovascular-catheter-fda-510k.jpg K193071 - Bashir Plus Endovascular Catheter K193071 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Thrombolex, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k193179/ 2019-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k193179-ev1000-clinical-platform-fda-510k.jpg K193179 - EV1000 Clinical Platform K193179 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Dec 2019. https://www.510kdatabase.net/k193219/ 2019-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k193219-g-surgical-marksman-system-fda-510k.jpg K193219 - G Surgical Marksman System K193219 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: G Surgical, LLC. Cleared Dec 2019. https://www.510kdatabase.net/k181548/ 2019-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k181548-pantheon-spinal-pontus-interbody-fda-510k.jpg K181548 - Pantheon Spinal Pontus Interbody Fusion Device K181548 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Pantheon Spinal. Cleared Dec 2019. https://www.510kdatabase.net/k190394/ 2019-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k190394-sunclear-aligner-system-fda-510k.jpg K190394 - SunClear Aligner system K190394 is a FDA 510(k) cleared dental medical device. Manufacturer: Sun Dental Laboratories, LLC. Cleared Dec 2019. https://www.510kdatabase.net/k190903/ 2019-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k190903-lawson-retrograde-nephrostomy-wire-fda-510k.jpg K190903 - Lawson Retrograde Nephrostomy Wire Puncture Set K190903 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Dec 2019. https://www.510kdatabase.net/k191306/ 2019-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k191306-llis-vittra-aps-fda-510k.jpg K191306 - Llis, Vittra APS K191306 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentscare Ltda. Cleared Dec 2019. https://www.510kdatabase.net/k191751/ 2019-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k191751-em-provisional-fda-510k.jpg K191751 - EM Provisional K191751 is a FDA 510(k) cleared dental medical device. Manufacturer: Hiossen, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k191834/ 2019-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k191834-stand-alone-alif-titanium-system-fda-510k.jpg K191834 - Stand-Alone ALIF Titanium System K191834 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k192539/ 2019-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k192539-deka-luxea-fda-510k.jpg K192539 - Deka Luxea K192539 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: El.En Electronic Engineering Spa. Cleared Dec 2019. https://www.510kdatabase.net/k192744/ 2019-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k192744-corridor-fixation-system-fda-510k.jpg K192744 - CORRIDOR Fixation System K192744 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k192762/ 2019-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k192762-physio-flex-annuloplasty-ring-fda-510k.jpg K192762 - Physio Flex Annuloplasty Ring K192762 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Dec 2019. https://www.510kdatabase.net/k192943/ 2019-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k192943-cedia-heroin-metabolite-6-am-assay-fda-510k.jpg K192943 - CEDIA Heroin Metabolite (6-AM) assay K192943 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Microgenics Corporation. Cleared Dec 2019. https://www.510kdatabase.net/k193174/ 2019-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k193174-keos-lumbar-ibfd-fda-510k.jpg K193174 - Keos Lumbar IBFD K193174 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Keos. Cleared Dec 2019. https://www.510kdatabase.net/k190833/ 2019-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k190833-axs-vecta-aspiration-catheter-fda-510k.jpg K190833 - AXS Vecta Aspiration Catheter K190833 is a FDA 510(k) cleared neurology medical device. Manufacturer: Stryker Neurovascular. Cleared Dec 2019. https://www.510kdatabase.net/k192356/ 2019-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k192356-airlock-centrolock-osteosynthesis-fda-510k.jpg K192356 - Airlock Centrolock Osteosynthesis Implant System K192356 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Novastep. Cleared Dec 2019. https://www.510kdatabase.net/k182731/ 2019-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k182731-corelink-navigation-instruments-fda-510k.jpg K182731 - Corelink Navigation Instruments K182731 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corelink, LLC. Cleared Dec 2019. https://www.510kdatabase.net/k183424/ 2019-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k183424-ambar-ambar-aps-ambar-universal-aps-fda-510k.jpg K183424 - Ambar, Ambar APS, Ambar Universal APS K183424 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentscare Ltda. Cleared Dec 2019. https://www.510kdatabase.net/k190715/ 2019-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k190715-endorotor-console-endorotor-catheter-fda-510k.jpg K190715 - EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Roll Stand K190715 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Interscope, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k190717/ 2019-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k190717-infrared-thermometer-model-pc808-fda-510k.jpg K190717 - Infrared Thermometer, model: PC808 K190717 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen Pacom Medical Instruments Co., Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k190738/ 2019-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k190738-myshoulder-placement-guides-fda-510k.jpg K190738 - MyShoulder Placement Guides K190738 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Dec 2019. https://www.510kdatabase.net/k190742/ 2019-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k190742-epiflo-28-fda-510k.jpg K190742 - EPIFLO-28 K190742 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Neogenix, LLC Dba Ogenix. Cleared Dec 2019. https://www.510kdatabase.net/k190752/ 2019-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k190752-satisfaite-fda-510k.jpg K190752 - Satisfaite K190752 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Femmepharma Consumer Healthcare, LLC. Cleared Dec 2019. https://www.510kdatabase.net/k191106/ 2019-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k191106-c50-and-c80-multi-parameter-patient-fda-510k.jpg K191106 - C50 and C80 Multi-parameter Patient Monitor K191106 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Comen Medical Instruments Co.,Ltd. Cleared Dec 2019. https://www.510kdatabase.net/k191118/ 2019-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k191118-avanti-distal-radius-and-forearm-system-fda-510k.jpg K191118 - Avanti Distal Radius and Forearm System K191118 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Avanti Orthopaedics, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k191796/ 2019-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k191796-neo-cage-system-fda-510k.jpg K191796 - Neo Cage System K191796 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Neo Medical SA. Cleared Dec 2019. https://www.510kdatabase.net/k192130/ 2019-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k192130-icobrain-fda-510k.jpg K192130 - Icobrain K192130 is a FDA 510(k) cleared radiology medical device. Manufacturer: Icometrix NV. Cleared Dec 2019. https://www.510kdatabase.net/k192152/ 2019-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k192152-dc-80dc-80-prodc-80-expdc-80sdc-85dc-fda-510k.jpg K192152 - DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85/DC-86/DC-86S/DC-89/DC-TV/DC-TQ Diagnostic Ultrasound System K192152 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k192220/ 2019-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k192220-relion-premier-classic-blood-glucose-fda-510k.jpg K192220 - ReliOn Premier Classic Blood Glucose Monitoring System K192220 is a FDA 510(k) cleared chemistry medical device. Manufacturer: I-Sens, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k192362/ 2019-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k192362-aero-blue-performance-surgical-gowns-fda-510k.jpg K192362 - Aero Blue Performance Surgical Gowns K192362 is a FDA 510(k) cleared general hospital medical device. Manufacturer: O&M Halyard, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k192370/ 2019-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k192370-medrad-stellant-flex-ct-injection-fda-510k.jpg K192370 - MEDRAD Stellant FLEX CT Injection System with Certegra Workstation K192370 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bayer Medical Care, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k192531/ 2019-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k192531-qyscore-software-fda-510k.jpg K192531 - QyScore Software K192531 is a FDA 510(k) cleared radiology medical device. Manufacturer: Qynapse. Cleared Dec 2019. https://www.510kdatabase.net/k192554/ 2019-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k192554-decimal3d-fda-510k.jpg K192554 - decimal3D K192554 is a FDA 510(k) cleared radiology medical device. Manufacturer: .Decimal, LLC. Cleared Dec 2019. https://www.510kdatabase.net/k192569/ 2019-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k192569-diode-laser-therapy-system-fda-510k.jpg K192569 - Diode Laser Therapy System K192569 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: San HE Lefis Electronics Co., Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k192627/ 2019-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k192627-laser-hair-growth-cap-fda-510k.jpg K192627 - Laser Hair Growth Cap K192627 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shang FA Biotechnology Co.. Cleared Dec 2019. https://www.510kdatabase.net/k192647/ 2019-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k192647-neria-guard-infusion-set-fda-510k.jpg K192647 - neria guard Infusion Set K192647 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Unomedical A/S. Cleared Dec 2019. https://www.510kdatabase.net/k192829/ 2019-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k192829-demetra-bdem-01-dermatoscope-fda-510k.jpg K192829 - Demetra BDEM-01 Dermatoscope K192829 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Barco N.V.. Cleared Dec 2019. https://www.510kdatabase.net/k193148/ 2019-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k193148-vapro-plus-pocket-vapro-plus-fda-510k.jpg K193148 - VaPro Plus Pocket, VaPro Plus K193148 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hollister Incorporated. Cleared Dec 2019. https://www.510kdatabase.net/k193162/ 2019-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k193162-epi-sense-guided-coagulation-system-fda-510k.jpg K193162 - EPi-Sense Guided Coagulation System with VisiTrax K193162 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: AtriCure, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k193170/ 2019-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k193170-deep-learning-image-reconstruction-fda-510k.jpg K193170 - Deep Learning Image Reconstruction K193170 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare Japan Corporation. Cleared Dec 2019. https://www.510kdatabase.net/k193173/ 2019-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k193173-careview-1800le-fda-510k.jpg K193173 - CareView 1800Le K193173 is a FDA 510(k) cleared radiology medical device. Manufacturer: Careray Digital Medical System Co., Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k193194/ 2019-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k193194-crosstorq-14-guidewire-fda-510k.jpg K193194 - CrossTorq 14 Guidewire K193194 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Scientia Cardio Access, LLC. Cleared Dec 2019. https://www.510kdatabase.net/k193202/ 2019-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k193202-exalt-model-d-single-use-duodenoscope-fda-510k.jpg K193202 - EXALT Model D Single-Use Duodenoscope, EXALT Controller K193202 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Dec 2019. https://www.510kdatabase.net/k193317/ 2019-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k193317-corelite-x-ray-specimen-cabinet-fda-510k.jpg K193317 - CoreLite X-Ray Specimen Cabinet K193317 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cirdan Imaging Limited. Cleared Dec 2019. https://www.510kdatabase.net/k193344/ 2019-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k193344-tri-ex-extraction-balloon-with-fda-510k.jpg K193344 - Tri-Ex Extraction Balloon with Multiple Sizing K193344 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Wilson-Cook Medical, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/den190034/ 2019-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/den190034-control-iq-technology-fda-510k.jpg DEN190034 - Control-IQ Technology DEN190034 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Tandem Diabetes Care, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k182987/ 2019-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k182987-genesys-spine-3dp-lumbar-interbody-fda-510k.jpg K182987 - Genesys Spine 3DP Lumbar Interbody System K182987 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Genesys Spine. Cleared Dec 2019. https://www.510kdatabase.net/k190537/ 2019-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k190537-bio-c-sealer-ion-fda-510k.jpg K190537 - BIO-C Sealer Ion+ K190537 is a FDA 510(k) cleared dental medical device. Manufacturer: Angelus Industria DE Produtos Odontologicos S/A. Cleared Dec 2019. https://www.510kdatabase.net/k190673/ 2019-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k190673-health-expert-electronic-stimulator-fda-510k.jpg K190673 - Health Expert Electronic Stimulator K190673 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Osto Technology Company Limited. Cleared Dec 2019. https://www.510kdatabase.net/k190793/ 2019-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k190793-tablo-hemodialysis-system-tablo-fda-510k.jpg K190793 - Tablo Hemodialysis System, Tablo Cartridge K190793 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Outset Medical, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k191163/ 2019-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k191163-lumax-guiding-catheter-fda-510k.jpg K191163 - Lumax Guiding Catheter K191163 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Dec 2019. https://www.510kdatabase.net/k192340/ 2019-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k192340-optomonitor-fda-510k.jpg K192340 - OptoMonitor K192340 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Opsens, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k192505/ 2019-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k192505-hs50hs60-diagnostics-ultrasound-system-fda-510k.jpg K192505 - HS50/HS60 Diagnostics Ultrasound System K192505 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Medison Co., Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k192938/ 2019-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k192938-invictus-spinal-fixation-system-fda-510k.jpg K192938 - Invictus™ Spinal Fixation System K192938 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k193133/ 2019-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k193133-blue-rhino-g1-multi-percutaneous-fda-510k.jpg K193133 - Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G1-Multi Percutaneous Tracheostomy Introducer Tray, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray, Weinmann-Multi Percutaneous Tracheostomy Exchange Set K193133 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Cook Incorporated. Cleared Dec 2019. https://www.510kdatabase.net/k193157/ 2019-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k193157-arthrex-39mm-corkscrew-suture-anchor-fda-510k.jpg K193157 - Arthrex 3.9mm Corkscrew Suture Anchor K193157 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/den180056/ 2019-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/den180056-gsp-neonatal-creatine-kinase-mm-kit-fda-510k.jpg DEN180056 - GSP Neonatal Creatine Kinase - MM kit DEN180056 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Perkinelmer, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k182739/ 2019-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k182739-endotracheal-tube-with-evacuation-lumen-fda-510k.jpg K182739 - Endotracheal Tube with Evacuation Lumen K182739 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Well Lead Medical Co., Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k190508/ 2019-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k190508-evo-450-series-high-speed-handpieces-fda-510k.jpg K190508 - EVO 450 series High Speed Handpieces K190508 is a FDA 510(k) cleared dental medical device. Manufacturer: Ttbio Corp.. Cleared Dec 2019. https://www.510kdatabase.net/k191086/ 2019-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k191086-exciplex-fda-510k.jpg K191086 - Exciplex K191086 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Clarteis. Cleared Dec 2019. https://www.510kdatabase.net/k191618/ 2019-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k191618-sleeptight-mouthpiece-stz-fda-510k.jpg K191618 - SleepTight Mouthpiece STZ K191618 is a FDA 510(k) cleared dental medical device. Manufacturer: Michael D Williams Dds PA. Cleared Dec 2019. https://www.510kdatabase.net/k191880/ 2019-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k191880-reprocessed-achieve-advance-mapping-fda-510k.jpg K191880 - Reprocessed Achieve Advance Mapping Diagnostic Electrophysiology Catheter K191880 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Innovative Health, LLC. Cleared Dec 2019. https://www.510kdatabase.net/k192149/ 2019-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k192149-mis-dental-implant-system-fda-510k.jpg K192149 - MIS Dental Implant System K192149 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k192507/ 2019-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k192507-lospa-ii-knee-system-fda-510k.jpg K192507 - LOSPA II Knee System K192507 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corentec Co., Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k192571/ 2019-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k192571-nemoscan-fda-510k.jpg K192571 - NemoScan K192571 is a FDA 510(k) cleared radiology medical device. Manufacturer: Software Nemotec S.L.. Cleared Dec 2019. https://www.510kdatabase.net/k193123/ 2019-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k193123-fujifilm-distal-cap-models-33-40-fda-510k.jpg K193123 - FUJIFILM Distal Cap Models 33-40 K193123 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fujifilm Corporation. Cleared Dec 2019. https://www.510kdatabase.net/k193126/ 2019-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k193126-hi-torque-infiltrac-guide-wire-family-fda-510k.jpg K193126 - HI-TORQUE InfilTrac Guide Wire Family K193126 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Vascular. Cleared Dec 2019. https://www.510kdatabase.net/k193132/ 2019-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k193132-clungene-hcg-pregnancy-rapid-test-fda-510k.jpg K193132 - CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream K193132 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Hangzhou Clongene Biotech Co., Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k193135/ 2019-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k193135-tsolution-one-total-knee-application-fda-510k.jpg K193135 - TSolution One Total Knee Application K193135 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: THINK Surgical, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k193167/ 2019-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k193167-nxtag-respiratory-pathogen-panel-nxtag-fda-510k.jpg K193167 - NxTAG Respiratory Pathogen Panel, NxTAG Respiratory Pathogen Panel Files, SYNCT Software K193167 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Luminex Molecular Diagnostics, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k190239/ 2019-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k190239-single-use-aspiration-needle-fda-510k.jpg K190239 - Single Use Aspiration Needle K190239 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Dec 2019. https://www.510kdatabase.net/k192287/ 2019-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k192287-transpara-fda-510k.jpg K192287 - Transpara K192287 is a FDA 510(k) cleared radiology medical device. Manufacturer: Screenpoint Medical B.V.. Cleared Dec 2019. https://www.510kdatabase.net/k192319/ 2019-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k192319-hera-w9-diagnostic-ultrasound-system-fda-510k.jpg K192319 - HERA W9 Diagnostic Ultrasound System, HERA W10 Diagnostic Ultrasound System K192319 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Medison Co., Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k192516/ 2019-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k192516-diode-laser-808nm-fda-510k.jpg K192516 - Diode Laser 808nm K192516 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Beijing Superlaser Technology Co., Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k192533/ 2019-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k192533-health-line-ct-cvc-fda-510k.jpg K192533 - Health Line CT CVC K192533 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Health Line International Corporation. Cleared Dec 2019. https://www.510kdatabase.net/k192929/ 2019-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k192929-system-1e-liquid-chemical-sterilant-fda-510k.jpg K192929 - SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6800, SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model P6900 K192929 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Dec 2019. https://www.510kdatabase.net/k181900/ 2019-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k181900-dental-high-speed-handpiece-dental-low-fda-510k.jpg K181900 - Dental high speed handpiece, Dental low speed handpiece K181900 is a FDA 510(k) cleared dental medical device. Manufacturer: Foshan Cicada Dental Instrument Co, Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k190968/ 2019-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k190968-cedia-benzodiazepine-assay-fda-510k.jpg K190968 - CEDIA Benzodiazepine Assay K190968 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Microgenics Corporation. Cleared Dec 2019. https://www.510kdatabase.net/k191054/ 2019-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k191054-southern-implants-max-implant-system-fda-510k.jpg K191054 - Southern Implants MAX Implant System K191054 is a FDA 510(k) cleared dental medical device. Manufacturer: Southern Implants (Pty), Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k191700/ 2019-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k191700-eyestat-fda-510k.jpg K191700 - EyeStat K191700 is a FDA 510(k) cleared neurology medical device. Manufacturer: Blinktbi, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k191793/ 2019-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k191793-nebula-brand-locking-bone-plates-and-fda-510k.jpg K191793 - Nebula Brand Locking Bone Plates and Screws Osteosynthesis Plating System, Nebula Brand of DHS Plating System K191793 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nebula Surgical Private Limited. Cleared Dec 2019. https://www.510kdatabase.net/k191895/ 2019-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k191895-straumann-mini-implants-fda-510k.jpg K191895 - Straumann Mini Implants K191895 is a FDA 510(k) cleared dental medical device. Manufacturer: Institut Straumann AG. Cleared Dec 2019. https://www.510kdatabase.net/k192225/ 2019-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k192225-legacy-ocufilcon-d-performance-tinted-fda-510k.jpg K192225 - Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) Daily Wear Contact Lenses K192225 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Vizionfocus, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k192439/ 2019-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k192439-jeti-peripheral-thrombectomy-system-fda-510k.jpg K192439 - JETi Peripheral Thrombectomy System K192439 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Walk Vascular, LLC. Cleared Dec 2019. https://www.510kdatabase.net/k192442/ 2019-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k192442-ffrangio-fda-510k.jpg K192442 - FFRangio K192442 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cathworks, Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k192522/ 2019-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k192522-tsv-bellatek-express-and-bellatek-flex-fda-510k.jpg K192522 - TSV BellaTek Express and BellaTek Flex Abutments K192522 is a FDA 510(k) cleared dental medical device. Manufacturer: Biomet 3i, LLC. Cleared Dec 2019. https://www.510kdatabase.net/k192885/ 2019-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k192885-ctm-mobility-scooter-hs-268-fda-510k.jpg K192885 - C.T.M. Mobility Scooter HS-268 K192885 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Chien TI Enterprise Co., Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k190273/ 2019-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k190273-t3-platform-software-fda-510k.jpg K190273 - T3 Platform software K190273 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Etiometry, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k192279/ 2019-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k192279-phantommsk-trauma-fda-510k.jpg K192279 - PhantomMSK Trauma K192279 is a FDA 510(k) cleared radiology medical device. Manufacturer: OrthoGrid Systems, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k183052/ 2019-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k183052-id-cap-system-fda-510k.jpg K183052 - ID-Cap System K183052 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Etectrx, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k190382/ 2019-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k190382-intraocular-pressure-tonometer-easyton-fda-510k.jpg K190382 - Intraocular Pressure Tonometer EASYTON K190382 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Company Elamed. Cleared Dec 2019. https://www.510kdatabase.net/k190552/ 2019-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k190552-jj-implant-system-fda-510k.jpg K190552 - JJ Implant System K190552 is a FDA 510(k) cleared dental medical device. Manufacturer: Jj Implants. Cleared Dec 2019. https://www.510kdatabase.net/k190612/ 2019-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k190612-equinox-balloon-dilatation-catheter-fda-510k.jpg K190612 - EQUINOX Balloon Dilatation Catheter K190612 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Dornier Medtech America, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k190656/ 2019-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k190656-dual-mobility-longevity-and-vivacit-e-fda-510k.jpg K190656 - Dual Mobility - Longevity and Vivacit-E Polyethylene Hip Bearings K190656 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k191239/ 2019-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k191239-smart-peak-flow-meter-fda-510k.jpg K191239 - Smart Peak Flow Meter K191239 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Guangzhou Homesun Medical Technology Co., Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k191279/ 2019-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k191279-disposable-spo2-sensor-fda-510k.jpg K191279 - Disposable SpO2 Sensor K191279 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Caremed Medical Technology Co., Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k191861/ 2019-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k191861-aurora-surgiscope-system-fda-510k.jpg K191861 - Aurora Surgiscope System K191861 is a FDA 510(k) cleared neurology medical device. Manufacturer: Rebound Therapeutics. Cleared Dec 2019. https://www.510kdatabase.net/k192324/ 2019-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k192324-sheridan-spiral-flex-endotracheal-tubes-fda-510k.jpg K192324 - Sheridan Spiral-Flex Endotracheal Tubes K192324 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Teleflexmedical, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k192443/ 2019-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k192443-dextile-anatomical-mesh-fda-510k.jpg K192443 - Dextile Anatomical Mesh K192443 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sofradim Production. Cleared Dec 2019. https://www.510kdatabase.net/k192521/ 2019-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k192521-intense-pulsed-light-treatment-system-fda-510k.jpg K192521 - Intense Pulsed Light Treatment System K192521 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shangdong Huamei Technology Co., Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k192773/ 2019-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k192773-allive-fda-510k.jpg K192773 - ALLIVE K192773 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nu Eyne Co., Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k193030/ 2019-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k193030-avenir-muller-stem-avenir-cemented-hip-fda-510k.jpg K193030 - Avenir Muller Stem, Avenir Cemented Hip Stem K193030 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer GmbH. Cleared Dec 2019. https://www.510kdatabase.net/k182758/ 2019-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k182758-mci-cmf-system-fda-510k.jpg K182758 - MCI - CMF System K182758 is a FDA 510(k) cleared dental medical device. Manufacturer: Mci Medical Concept Innovation, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k190660/ 2019-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k190660-g7-acetabular-system-longevity-highly-fda-510k.jpg K190660 - G7 Acetabular System Longevity Highly Crosslinked Polyethylene, G7 Acetabular System Vivacit-E Vitamin E Highly Crosslinked Polyethylene K190660 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k191191/ 2019-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k191191-neodent-implant-system-temporary-fda-510k.jpg K191191 - Neodent Implant System - Temporary Abutments K191191 is a FDA 510(k) cleared dental medical device. Manufacturer: Jjgc Industria E Comercio DE Materiais Dentarios S.A.. Cleared Dec 2019. https://www.510kdatabase.net/k191250/ 2019-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k191250-southern-implants-peek-abutments-fda-510k.jpg K191250 - Southern Implants PEEK Abutments K191250 is a FDA 510(k) cleared dental medical device. Manufacturer: Southern Implants (Pty), Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k191760/ 2019-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k191760-pico-14-single-use-negative-pressure-fda-510k.jpg K191760 - PICO 14 Single Use Negative Pressure Wound Therapy System K191760 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew Medical Limited. Cleared Dec 2019. https://www.510kdatabase.net/k191804/ 2019-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k191804-tomi-scope-fda-510k.jpg K191804 - TOMi Scope K191804 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Photonicare, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k191864/ 2019-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k191864-21hk512d-fda-510k.jpg K191864 - 21HK512D K191864 is a FDA 510(k) cleared radiology medical device. Manufacturer: Lg Electronics.Inc. Cleared Dec 2019. https://www.510kdatabase.net/k191962/ 2019-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k191962-vitra-2-fda-510k.jpg K191962 - Vitra 2 K191962 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Quantel Medical. Cleared Dec 2019. https://www.510kdatabase.net/k191996/ 2019-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k191996-bc-reflex-uni-knee-system-fda-510k.jpg K191996 - BC Reflex Uni Knee System K191996 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Bodycad Laboratories, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k192224/ 2019-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k192224-btl-899-fda-510k.jpg K192224 - BTL-899 K192224 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Btl. Cleared Dec 2019. https://www.510kdatabase.net/k192482/ 2019-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k192482-elekta-unity-fda-510k.jpg K192482 - Elekta Unity K192482 is a FDA 510(k) cleared radiology medical device. Manufacturer: Elekta Limited. Cleared Dec 2019. https://www.510kdatabase.net/k192766/ 2019-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k192766-digital-intraoral-imaging-plate-system-fda-510k.jpg K192766 - Digital Intraoral Imaging Plate System K192766 is a FDA 510(k) cleared radiology medical device. Manufacturer: Fsusen Technology Co., Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k193028/ 2019-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k193028-medrad-mark-7-arterion-injection-system-fda-510k.jpg K193028 - MEDRAD Mark 7 Arterion Injection System K193028 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bayer Medical Care, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/den190016/ 2019-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/den190016-cobas-vivodx-mrsa-fda-510k.jpg DEN190016 - cobas vivoDx MRSA DEN190016 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Molecular Systems, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k191371/ 2019-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k191371-moleculight-ix-fda-510k.jpg K191371 - MolecuLight i:X K191371 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Moleculight, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k191379/ 2019-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k191379-relizorb-fda-510k.jpg K191379 - RELiZORB K191379 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Alcresta Therapeutics, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k191759/ 2019-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k191759-medline-quick-switch-valve-with-enfit-fda-510k.jpg K191759 - Medline Quick Switch Valve with ENFit Connector K191759 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medline Industries, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k192335/ 2019-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k192335-tracker-kyphoplasty-system-fda-510k.jpg K192335 - TRACKER Kyphoplasty System K192335 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: GS Medical Co., Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k192348/ 2019-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k192348-sicat-implant-v20-fda-510k.jpg K192348 - SICAT Implant V2.0 K192348 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sicat GmbH & Co. KG. Cleared Dec 2019. https://www.510kdatabase.net/k192430/ 2019-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k192430-epic-980-fda-510k.jpg K192430 - Epic 980 K192430 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Biolase, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k193020/ 2019-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k193020-venapro-vascular-therapy-system-fda-510k.jpg K193020 - VenaPro Vascular Therapy System K193020 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Innovamed Health, LLC. Cleared Dec 2019. https://www.510kdatabase.net/k193068/ 2019-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k193068-airos-8-sequential-compression-device-fda-510k.jpg K193068 - AIROS 8 Sequential Compression Device K193068 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Airos Medical, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k193069/ 2019-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k193069-airos-6-sequential-compression-device-fda-510k.jpg K193069 - AIROS 6 Sequential Compression Device K193069 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Airos Medical, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k183371/ 2019-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k183371-deka-tiac-1-fda-510k.jpg K183371 - Deka Tiac 1 K183371 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: El..En. Electroic Engineering Spa. Cleared Dec 2019. https://www.510kdatabase.net/k191522/ 2019-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k191522-straumann-modular-cassette-fda-510k.jpg K191522 - Straumann Modular Cassette K191522 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Institut Straumann AG. Cleared Dec 2019. https://www.510kdatabase.net/k192132/ 2019-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k192132-seaspine-beachside-system-fda-510k.jpg K192132 - SeaSpine Beachside System K192132 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared Dec 2019. https://www.510kdatabase.net/k192473/ 2019-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k192473-exsomed-wrist-plating-system-fda-510k.jpg K192473 - Exsomed Wrist Plating System K192473 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exsomed Corporation. Cleared Dec 2019. https://www.510kdatabase.net/k192528/ 2019-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k192528-co2-laser-therapy-system-fda-510k.jpg K192528 - CO2 Laser Therapy System K192528 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shangdong Huamei Technology Co., Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k193009/ 2019-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k193009-promisemed-heel-blood-lancet-fda-510k.jpg K193009 - Promisemed Heel Blood Lancet K193009 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Promisemed Hangzhou Meditech Co., Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k193083/ 2019-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k193083-must-sacral-illiac-screw-and-pelvic-fda-510k.jpg K193083 - M.U.S.T. Sacral Illiac Screw and Pelvic Trauma System K193083 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Dec 2019. https://www.510kdatabase.net/k193107/ 2019-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k193107-trisalus-infusion-system-fda-510k.jpg K193107 - TriSalus Infusion System K193107 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Trisalus Life Sciences. Cleared Dec 2019. https://www.510kdatabase.net/k193160/ 2019-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k193160-glidesheath-slender-tibial-pedal-kit-fda-510k.jpg K193160 - Glidesheath Slender Tibial Pedal Kit K193160 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Coporation. Cleared Dec 2019. https://www.510kdatabase.net/k182819/ 2019-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k182819-decanting-device-fda-510k.jpg K182819 - Decanting Device K182819 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Gcmedica Enterprise Ltd.(Wuxi). Cleared Dec 2019. https://www.510kdatabase.net/k183622/ 2019-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k183622-nasalcease-and-bleedcease-fda-510k.jpg K183622 - NasalCEASE and BleedCEASE K183622 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Les Laboratoires Brothier S.A.. Cleared Dec 2019. https://www.510kdatabase.net/k190009/ 2019-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k190009-sunmas-tens-pms-model-sm9187-sm9180l-fda-510k.jpg K190009 - Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S) K190009 is a FDA 510(k) cleared neurology medical device. Manufacturer: Hong Qiangxing (Shenzhen) Electronics Limited. Cleared Dec 2019. https://www.510kdatabase.net/k190588/ 2019-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k190588-integra-titan-reverse-shoulder-system-fda-510k.jpg K190588 - Integra TITAN Reverse Shoulder System K190588 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Integra LifeSciences Corporation. Cleared Dec 2019. https://www.510kdatabase.net/k190659/ 2019-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k190659-ureteral-stent-open-tipclosed-fda-510k.jpg K190659 - Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via Ureterorenoscope Open Tip/Closed Tip, Pediatric Ureteral Stent Open Tip/Closed Tip, Mono J Urinary Diversion Ureteral Stent Open Tip/Closed Tip, Multiloop Ureteral Stent Open Tip/Closed Tip K190659 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Allwin Medical Devices, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k190876/ 2019-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k190876-mcarepowder-free-nitrile-blue-fda-510k.jpg K190876 - mCare®Powder-free Nitrile Blue Examination Gloves with Chemotherapy Drugs Labeling Claimed K190876 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Mercator Medical (Thailand), Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k190987/ 2019-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k190987-uroject12-syringe-lever-fda-510k.jpg K190987 - Uroject12 Syringe Lever K190987 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Urogen Pharma, Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k191088/ 2019-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k191088-checkme-o2-pulse-oximeter-fda-510k.jpg K191088 - Checkme O2 Pulse Oximeter K191088 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Viatom Technology Co., Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/k191656/ 2019-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k191656-zipbond-fda-510k.jpg K191656 - Zipbond K191656 is a FDA 510(k) cleared dental medical device. Manufacturer: Sdi Limited. Cleared Dec 2019. https://www.510kdatabase.net/k191722/ 2019-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k191722-vital-navigation-system-fda-510k.jpg K191722 - Vital Navigation System K191722 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer Biomet Spine, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k192038/ 2019-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k192038-emprint-visualization-application-fda-510k.jpg K192038 - Emprint Visualization Application K192038 is a FDA 510(k) cleared radiology medical device. Manufacturer: Covidien, LLC. Cleared Dec 2019. https://www.510kdatabase.net/k192374/ 2019-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k192374-cardinal-health-level-3-surgical-mask-fda-510k.jpg K192374 - Cardinal Health™ Level 3 Surgical Mask with Anti-Fog Foam Strip K192374 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cardinal Health200, LLC. Cleared Dec 2019. https://www.510kdatabase.net/k192394/ 2019-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k192394-hi-fatigue-bone-cement-fda-510k.jpg K192394 - Hi-Fatigue Bone Cement K192394 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osartis GmbH. Cleared Dec 2019. https://www.510kdatabase.net/k192666/ 2019-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k192666-promisemed-blood-lancet-verifine-fda-510k.jpg K192666 - Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety Lancet K192666 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Promisemed Hangzhou Meditech Co., Ltd.. Cleared Dec 2019. https://www.510kdatabase.net/den180014/ 2019-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/den180014-woundchek-bacterial-status-fda-510k.jpg DEN180014 - WOUNDCHEK Bacterial Status DEN180014 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Alere Scarborough, Inc.. Cleared Dec 2019. https://www.510kdatabase.net/k193040/ 2019-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k193040-resorbable-mesh-device-fda-510k.jpg K193040 - Resorbable Mesh Device K193040 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared Nov 2019. https://www.510kdatabase.net/k190710/ 2019-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k190710-elia-symphonys-immunoassay-fda-510k.jpg K190710 - EliA SymphonyS Immunoassay K190710 is a FDA 510(k) cleared immunology medical device. Manufacturer: Phadia AB. Cleared Nov 2019. https://www.510kdatabase.net/k192105/ 2019-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k192105-innonix-antiviral-childs-face-mask-fda-510k.jpg K192105 - Innonix Antiviral Child's Face Mask K192105 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Innonix Technologies Limited. Cleared Nov 2019. https://www.510kdatabase.net/k192186/ 2019-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k192186-i-portal-neuro-otologic-test-center-i-fda-510k.jpg K192186 - I-Portal Neuro Otologic Test Center, I-Portal Video Nystagmography System, I-Portal Portable Assessment System - Nysragmograph K192186 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Neurolign USA, LLC. Cleared Nov 2019. https://www.510kdatabase.net/k192365/ 2019-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k192365-shoulder-innovations-total-shoulder-fda-510k.jpg K192365 - Shoulder Innovations Total Shoulder System K192365 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Shoulder Innovations, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k192782/ 2019-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k192782-asahi-crosswalk-peripheral-support-fda-510k.jpg K192782 - ASAHI CROSSWALK Peripheral Support Catheter K192782 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Asahi Intecc Co., Ltd.. Cleared Nov 2019. https://www.510kdatabase.net/k193034/ 2019-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k193034-axs-infinity-ls-plus-long-sheath-fda-510k.jpg K193034 - AXS Infinity LS Plus Long Sheath K193034 is a FDA 510(k) cleared neurology medical device. Manufacturer: Stryker Neurovascular. Cleared Nov 2019. https://www.510kdatabase.net/k190577/ 2019-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k190577-world-knee-total-knee-systems-fda-510k.jpg K190577 - World Knee Total Knee Systems K190577 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Signature Orthopaedics Pty, Ltd.. Cleared Nov 2019. https://www.510kdatabase.net/k190811/ 2019-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k190811-optimus-neuro-system-sterile-kit-fda-510k.jpg K190811 - Optimus NEURO System - Sterile Kit K190811 is a FDA 510(k) cleared neurology medical device. Manufacturer: Osteonic Co., Ltd.. Cleared Nov 2019. https://www.510kdatabase.net/k190955/ 2019-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k190955-hypotension-decision-assist-fda-510k.jpg K190955 - Hypotension Decision Assist K190955 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Directed Systems, Ltd.. Cleared Nov 2019. https://www.510kdatabase.net/k191032/ 2019-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k191032-fmri-hardware-system-fda-510k.jpg K191032 - fMRI Hardware System K191032 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nordicneurolab AS. Cleared Nov 2019. https://www.510kdatabase.net/k191428/ 2019-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k191428-ecg-cable-fda-510k.jpg K191428 - ECG Cable K191428 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Changke Connect Electronics Co., Ltd.. Cleared Nov 2019. https://www.510kdatabase.net/k191673/ 2019-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k191673-upper-arm-blood-pressure-monitor-fda-510k.jpg K191673 - Upper Arm Blood Pressure Monitor K191673 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Famidoc Technology Company Limited. Cleared Nov 2019. https://www.510kdatabase.net/k191911/ 2019-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k191911-3shape-splint-design-fda-510k.jpg K191911 - 3Shape Splint Design K191911 is a FDA 510(k) cleared dental medical device. Manufacturer: 3Shape A/S. Cleared Nov 2019. https://www.510kdatabase.net/k191987/ 2019-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k191987-orapeutic-fda-510k.jpg K191987 - Orapeutic K191987 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Forward Science. Cleared Nov 2019. https://www.510kdatabase.net/k192079/ 2019-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k192079-eosedge-fda-510k.jpg K192079 - EOSedge K192079 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eos Imaging. Cleared Nov 2019. https://www.510kdatabase.net/k192379/ 2019-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k192379-hi-fatigue-g-bone-cement-fda-510k.jpg K192379 - Hi-Fatigue G Bone Cement K192379 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osartis GmbH. Cleared Nov 2019. https://www.510kdatabase.net/k192438/ 2019-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k192438-rhythmia-hdxtm-mapping-system-fda-510k.jpg K192438 - Rhythmia HDxTM Mapping System K192438 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Nov 2019. https://www.510kdatabase.net/k192468/ 2019-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k192468-male-nelaton-tip-ready-to-use-fda-510k.jpg K192468 - Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter K192468 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hangzhou Bever Medical Devices Co., Ltd.. Cleared Nov 2019. https://www.510kdatabase.net/k192519/ 2019-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k192519-multi-modality-workstation-fda-510k.jpg K192519 - Multi-modality workstation K192519 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Beijing Superlaser Technology Co., Ltd.. Cleared Nov 2019. https://www.510kdatabase.net/k192791/ 2019-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k192791-diagnostic-ultrasound-system-fda-510k.jpg K192791 - Diagnostic Ultrasound System K192791 is a FDA 510(k) cleared radiology medical device. Manufacturer: Edan Instruments, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k192945/ 2019-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k192945-7d-surgical-system-cranial-biopsy-and-fda-510k.jpg K192945 - 7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application K192945 is a FDA 510(k) cleared neurology medical device. Manufacturer: 7D Surgical, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k182892/ 2019-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k182892-traus-dental-handpieces-fda-510k.jpg K182892 - TRAUS Dental Handpieces K182892 is a FDA 510(k) cleared dental medical device. Manufacturer: Saeshin Precision Co., Ltd.. Cleared Nov 2019. https://www.510kdatabase.net/k190911/ 2019-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k190911-physica-kr-liner-and-smr-reverse-fda-510k.jpg K190911 - Physica KR Liner and SMR Reverse Humeral Liner K190911 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Limacorporate. Cleared Nov 2019. https://www.510kdatabase.net/k191426/ 2019-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k191426-fibertak-button-fda-510k.jpg K191426 - FiberTak Button K191426 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k191502/ 2019-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k191502-heraeus-peripheral-guidewire-fda-510k.jpg K191502 - Heraeus Peripheral Guidewire K191502 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Heraeus Medical Components, LLC. Cleared Nov 2019. https://www.510kdatabase.net/k191961/ 2019-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k191961-orthogold-fda-510k.jpg K191961 - OrthoGold K191961 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Tissue Regeneration Technologies. Cleared Nov 2019. https://www.510kdatabase.net/k192026/ 2019-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k192026-peridot-intervertebral-body-fusion-fda-510k.jpg K192026 - Peridot Intervertebral body fusion System K192026 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Gbs Commonwealth Co., Ltd.. Cleared Nov 2019. https://www.510kdatabase.net/k192271/ 2019-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k192271-access-pct-access-pct-calibrators-fda-510k.jpg K192271 - Access PCT, Access PCT Calibrators K192271 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k192320/ 2019-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k192320-healthcxr-fda-510k.jpg K192320 - HealthCXR K192320 is a FDA 510(k) cleared radiology medical device. Manufacturer: Zebra Medical Vision, Ltd.. Cleared Nov 2019. https://www.510kdatabase.net/k192367/ 2019-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k192367-ion-endoluminal-system-fda-510k.jpg K192367 - Ion Endoluminal System K192367 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k192376/ 2019-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k192376-simplexa-vzv-swab-direct-simplexa-vzv-fda-510k.jpg K192376 - Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack K192376 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Diasorin Molecular, LLC. Cleared Nov 2019. https://www.510kdatabase.net/k192396/ 2019-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k192396-streamline-mis-spinal-fixation-system-fda-510k.jpg K192396 - Streamline MIS Spinal Fixation System K192396 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Pioneer Surgical Technology, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k192417/ 2019-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k192417-arix-cannulated-screw-system-fda-510k.jpg K192417 - ARIX Cannulated Screw System K192417 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Jeil Medical Corporation. Cleared Nov 2019. https://www.510kdatabase.net/k192738/ 2019-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k192738-etest-delafloxacin-dfx-0002-32-gml-fda-510k.jpg K192738 - ETEST Delafloxacin (DFX) (0.002-32 µg/mL) K192738 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Biomerieux S.A.. Cleared Nov 2019. https://www.510kdatabase.net/k192745/ 2019-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k192745-depuy-synthes-trauma-screws-fda-510k.jpg K192745 - DePuy Synthes Trauma Screws K192745 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k192764/ 2019-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k192764-neuroone-cortical-electrode-fda-510k.jpg K192764 - NeuroOne Cortical Electrode K192764 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neuroone, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k192907/ 2019-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k192907-advocate-pta-catheter-fda-510k.jpg K192907 - Advocate PTA Catheter K192907 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k192919/ 2019-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k192919-pinnacle-duofix-ha-acetabular-cup-fda-510k.jpg K192919 - Pinnacle Duofix HA Acetabular Cup Prosthesis K192919 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k192946/ 2019-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k192946-depuy-corail-amt-hip-prosthesis-fda-510k.jpg K192946 - DePuy Corail AMT Hip Prosthesis K192946 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k181845/ 2019-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k181845-pivot-system-sterilization-case-fda-510k.jpg K181845 - Pivot System Sterilization case K181845 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Rp Medical, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k190494/ 2019-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k190494-infant-incubator-fda-510k.jpg K190494 - Infant Incubator K190494 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ningbo David Medical Device Co., Ltd.. Cleared Nov 2019. https://www.510kdatabase.net/k190529/ 2019-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k190529-sozo-fda-510k.jpg K190529 - SOZO K190529 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: ImpediMed Limited. Cleared Nov 2019. https://www.510kdatabase.net/k190590/ 2019-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k190590-allwin-ovum-pickup-needles-ace-single-fda-510k.jpg K190590 - Allwin Ovum Pickup Needles (ACE Single Lumen Ovum Pickup Needle, OVUMPICK Double Lumen Ovum Pickup Needle, ACE-FL Single Lumen Ovum Pickup Needle with Flushing Line, ACE-M Manual Single Lumen Ovum Pickup Needle) K190590 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Allwin Medical Devices, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k191851/ 2019-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k191851-vs3-ir-fda-510k.jpg K191851 - VS3-IR K191851 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medtronic. Cleared Nov 2019. https://www.510kdatabase.net/k192248/ 2019-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k192248-cortina-max-lumbar-cage-system-fda-510k.jpg K192248 - Cortina™ [MAX] Lumbar Cage System K192248 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Neurostructures, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k192329/ 2019-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k192329-blue-latex-examination-powder-free-fda-510k.jpg K192329 - Blue Latex Examination Powder Free Gloves K192329 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jr Engineering & Medical Technologies (M) Sdn. Bhd.. Cleared Nov 2019. https://www.510kdatabase.net/k192788/ 2019-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k192788-advia-centaur-cortisol-cor-fda-510k.jpg K192788 - ADVIA Centaur Cortisol (COR) K192788 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k182712/ 2019-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k182712-dexis-carivu-3-in-1-by-kavo-fda-510k.jpg K182712 - DEXIS CariVu 3-in-1 by KaVo K182712 is a FDA 510(k) cleared dental medical device. Manufacturer: Kaltenbach & Voigt GmbH. Cleared Nov 2019. https://www.510kdatabase.net/k190760/ 2019-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k190760-cadwell-bolt-software-fda-510k.jpg K190760 - Cadwell Bolt Software K190760 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cadwell Industries, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k171899/ 2019-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k171899-revitalair-430f-fda-510k.jpg K171899 - Revitalair 430F K171899 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Oxavita Srl. Cleared Nov 2019. https://www.510kdatabase.net/k190331/ 2019-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k190331-applied-medical-laparoscopic-linear-fda-510k.jpg K190331 - Applied Medical Laparoscopic Linear Cutter K190331 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Applied Medical Resources Corporation. Cleared Nov 2019. https://www.510kdatabase.net/k190512/ 2019-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k190512-smartband-emr-kit-smartband-emr-pack-fda-510k.jpg K190512 - SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare K190512 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Intelligent Endoscopy. Cleared Nov 2019. https://www.510kdatabase.net/k190518/ 2019-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k190518-color-liquid-vita-liquid-fda-510k.jpg K190518 - Color Liquid, Vita Liquid K190518 is a FDA 510(k) cleared dental medical device. Manufacturer: Zirkonzahn Srl. Cleared Nov 2019. https://www.510kdatabase.net/k190697/ 2019-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k190697-prevena-plus-incision-management-fda-510k.jpg K190697 - PREVENA PLUS Incision Management System (No Ag) K190697 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Kci USA, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k190977/ 2019-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k190977-navina-smart-system-navina-classic-fda-510k.jpg K190977 - Navina Smart System, Navina Classic System K190977 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Dentsply Sirona. Cleared Nov 2019. https://www.510kdatabase.net/k191028/ 2019-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k191028-kls-martin-individual-patient-solutions-fda-510k.jpg K191028 - KLS Martin Individual Patient Solutions K191028 is a FDA 510(k) cleared dental medical device. Manufacturer: KLS-Martin L.P.. Cleared Nov 2019. https://www.510kdatabase.net/k191075/ 2019-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k191075-healy-fda-510k.jpg K191075 - Healy K191075 is a FDA 510(k) cleared neurology medical device. Manufacturer: Timewaver Production GmbH. Cleared Nov 2019. https://www.510kdatabase.net/k191103/ 2019-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k191103-parkell-desensitizer-gel-fda-510k.jpg K191103 - Parkell Desensitizer Gel K191103 is a FDA 510(k) cleared dental medical device. Manufacturer: Parkell, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k191236/ 2019-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k191236-3m-attest-steam-chemical-integrators-fda-510k.jpg K191236 - 3M™ Attest™ Steam Chemical Integrators K191236 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Nov 2019. https://www.510kdatabase.net/k191734/ 2019-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k191734-matristem-ubm-pericardial-patch-fda-510k.jpg K191734 - MatriStem UBM Pericardial Patch K191734 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Acell, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k191746/ 2019-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k191746-smr-tt-augmented-glenoid-system-fda-510k.jpg K191746 - SMR TT Augmented Glenoid System K191746 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Lima Corporate S.P.A.. Cleared Nov 2019. https://www.510kdatabase.net/k191754/ 2019-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k191754-hair-growth-system-fda-510k.jpg K191754 - Hair Growth System K191754 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Kunshan Bella Optical Technology Co., Ltd.. Cleared Nov 2019. https://www.510kdatabase.net/k191903/ 2019-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k191903-bruxzir-gt-gum-tissue-color-fda-510k.jpg K191903 - BruxZir GT (Gum Tissue) Color K191903 is a FDA 510(k) cleared dental medical device. Manufacturer: Prismatik Dentalcraft, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k192122/ 2019-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k192122-trevo-trak-21-microcatheter-fda-510k.jpg K192122 - Trevo Trak 21 Microcatheter K192122 is a FDA 510(k) cleared neurology medical device. Manufacturer: Stryker. Cleared Nov 2019. https://www.510kdatabase.net/k192126/ 2019-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k192126-amistem-p-short-neck-fda-510k.jpg K192126 - AMIStem-P Short Neck K192126 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Nov 2019. https://www.510kdatabase.net/k192157/ 2019-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k192157-6450-ultrasound-system-fda-510k.jpg K192157 - 6450 Ultrasound system K192157 is a FDA 510(k) cleared radiology medical device. Manufacturer: Esaote, S.P.A.. Cleared Nov 2019. https://www.510kdatabase.net/k192207/ 2019-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k192207-trevo-nxt-provue-retriever-fda-510k.jpg K192207 - Trevo NXT ProVue Retriever K192207 is a FDA 510(k) cleared neurology medical device. Manufacturer: Stryker. Cleared Nov 2019. https://www.510kdatabase.net/k192242/ 2019-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k192242-synergy-platform-synergy-infinity-fda-510k.jpg K192242 - Synergy Platform, Synergy, Infinity, VersaHD K192242 is a FDA 510(k) cleared radiology medical device. Manufacturer: Elekta Limited. Cleared Nov 2019. https://www.510kdatabase.net/k192260/ 2019-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k192260-everx-flow-fda-510k.jpg K192260 - everX Flow K192260 is a FDA 510(k) cleared dental medical device. Manufacturer: GC America, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k192270/ 2019-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k192270-leva-pelvic-digital-health-system-fda-510k.jpg K192270 - LEva Pelvic Digital Health System K192270 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Renovia, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k192336/ 2019-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k192336-navigated-anterolateral-disc-prep-fda-510k.jpg K192336 - Navigated Anterolateral Disc Prep Instruments K192336 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k192508/ 2019-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k192508-medsynapse-ris-pacs-medsynapse-vna-fda-510k.jpg K192508 - Medsynapse Ris Pacs & Medsynapse VNA K192508 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medsynaptic Private, Ltd.. Cleared Nov 2019. https://www.510kdatabase.net/k192603/ 2019-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k192603-spes-medica-subdermal-needle-electrodes-fda-510k.jpg K192603 - Spes Medica Subdermal Needle Electrodes K192603 is a FDA 510(k) cleared neurology medical device. Manufacturer: Spes Medica Srl. Cleared Nov 2019. https://www.510kdatabase.net/k192675/ 2019-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k192675-variax-foot-fda-510k.jpg K192675 - VariAx Foot K192675 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker GmbH. Cleared Nov 2019. https://www.510kdatabase.net/k192777/ 2019-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k192777-advia-centaur-ca-15-3-assay-fda-510k.jpg K192777 - ADVIA Centaur CA 15-3 assay K192777 is a FDA 510(k) cleared immunology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k192843/ 2019-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k192843-innovita-hcg-pregnancy-rapid-test-fda-510k.jpg K192843 - INNOVITA HCG Pregnancy Rapid Test Strip, INNOVITA HCG Pregnancy Rapid Test Cassette, INNOVITA HCG Pregnancy Rapid Test Midstream K192843 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Innovita (Tangshan) Biological Technology Co., Ltd.. Cleared Nov 2019. https://www.510kdatabase.net/k192877/ 2019-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k192877-senhance-surgical-system-fda-510k.jpg K192877 - Senhance Surgical System K192877 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Transenterix, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k192964/ 2019-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k192964-parcus-synd-ez-ss-fda-510k.jpg K192964 - Parcus Synd-EZ SS K192964 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Parcus Medical, LLC. Cleared Nov 2019. https://www.510kdatabase.net/k193017/ 2019-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k193017-evs-4343w-evs-4343wg-evs-4343wp-evs-fda-510k.jpg K193017 - EVS 4343W / EVS 4343WG / EVS 4343WP / EVS 3643W / EVS 3643WG / EVS 3643WP K193017 is a FDA 510(k) cleared radiology medical device. Manufacturer: DRTECH Corporation. Cleared Nov 2019. https://www.510kdatabase.net/k193031/ 2019-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k193031-expd-4343p-expd-3643p-fda-510k.jpg K193031 - EXPD 4343P, EXPD 3643P K193031 is a FDA 510(k) cleared radiology medical device. Manufacturer: DRTECH Corporation. Cleared Nov 2019. https://www.510kdatabase.net/k193036/ 2019-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k193036-c2-cryoballoon-endogrip-fda-510k.jpg K193036 - C2 CryoBalloon EndoGrip K193036 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Pentax Medical, A Division of Pentax of America, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k193041/ 2019-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k193041-hemochron-signature-elite-fda-510k.jpg K193041 - Hemochron Signature Elite K193041 is a FDA 510(k) cleared hematology medical device. Manufacturer: Accriva Diagnostics, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k181839/ 2019-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k181839-cvs-health-dry-mouth-spray-oralabs-dry-fda-510k.jpg K181839 - CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray K181839 is a FDA 510(k) cleared dental medical device. Manufacturer: Oralabs, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k190439/ 2019-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k190439-engage-partial-knee-system-fda-510k.jpg K190439 - Engage™ Partial Knee System K190439 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Engage Uni, LLC. Cleared Nov 2019. https://www.510kdatabase.net/k191464/ 2019-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k191464-asahi-ptca-guide-wire-asahi-sion-series-fda-510k.jpg K191464 - Asahi PTCA Guide Wire Asahi SION Series K191464 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Asahi Intecc Co., Ltd.. Cleared Nov 2019. https://www.510kdatabase.net/k191488/ 2019-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k191488-sam-io-intraosseous-access-system-fda-510k.jpg K191488 - SAM IO Intraosseous Access System K191488 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sam? Medical Products, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k192061/ 2019-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k192061-somatom-go-platform-somatom-gonow-goup-fda-510k.jpg K192061 - SOMATOM Go Platform – SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan & GO K192061 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k192124/ 2019-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k192124-canady-plasma-smart-xl-1000-fda-510k.jpg K192124 - Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories K192124 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Us Medical Innovations, LLC. Cleared Nov 2019. https://www.510kdatabase.net/k192266/ 2019-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k192266-m-blue-adjustable-shunt-system-fda-510k.jpg K192266 - M. Blue Adjustable Shunt System K192266 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k192299/ 2019-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k192299-lzi-cotinine-ii-enzyme-immunoassay-fda-510k.jpg K192299 - LZI Cotinine II Enzyme Immunoassay K192299 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Lin-Zhi International, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k192480/ 2019-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k192480-torpedo-gelatin-foam-fda-510k.jpg K192480 - Torpedo Gelatin Foam K192480 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biosphere Medical, S.A.. Cleared Nov 2019. https://www.510kdatabase.net/k192592/ 2019-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k192592-axis-plating-system-fda-510k.jpg K192592 - Axis Plating System K192592 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Extremity Medical, LLC. Cleared Nov 2019. https://www.510kdatabase.net/k192625/ 2019-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k192625-pg-pro-microcatheter-fda-510k.jpg K192625 - PG Pro Microcatheter K192625 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: MicroVention, Inc. A TERUMO Group Company. Cleared Nov 2019. https://www.510kdatabase.net/k192996/ 2019-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k192996-selectra-catheters-selectra-accessory-fda-510k.jpg K192996 - Selectra Catheters, Selectra Accessory Kit, Selectra Slitter Tool K192996 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biotronik, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k181953/ 2019-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k181953-sds12-dental-implant-fda-510k.jpg K181953 - SDS1.2 dental implant K181953 is a FDA 510(k) cleared dental medical device. Manufacturer: Sds Swiss Dental Solutions AG. Cleared Nov 2019. https://www.510kdatabase.net/k190497/ 2019-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k190497-ziehm-8000-fda-510k.jpg K190497 - Ziehm 8000 K190497 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ziehm Imaging GmbH. Cleared Nov 2019. https://www.510kdatabase.net/k191865/ 2019-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k191865-smartlite-pro-modular-led-curing-light-fda-510k.jpg K191865 - SmartLite Pro Modular LED Curing Light K191865 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona. Cleared Nov 2019. https://www.510kdatabase.net/k192281/ 2019-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k192281-aegis-anterior-lumbar-plate-system-alc-fda-510k.jpg K192281 - AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine System, BOWTI Anterior Buttress Staple Spinal System, DISCOVERY Screw System, EXPEDIUM Anterior Spine System, FRONTIER Anterior Scoliosis System, KANEDA Anterior Scoliosis System, KANEDA SR Anterior Spinal System, M-2 Anterior Plate System, MOUNTAINEER Laminoplasty System, PROFILE Anterior Thoracolumbar Plate System, UNIVERSITY PLATE Anterior System, VIPER F2 Facet Fixation System K192281 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International SARL. Cleared Nov 2019. https://www.510kdatabase.net/k192664/ 2019-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k192664-fujifilm-endoscope-model-ec-760z-vl-fda-510k.jpg K192664 - FUJIFILM Endoscope Model EC-760Z-V/L K192664 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fujifilm Corporation. Cleared Nov 2019. https://www.510kdatabase.net/k192672/ 2019-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k192672-upmr-790-fda-510k.jpg K192672 - uPMR 790 K192672 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Nov 2019. https://www.510kdatabase.net/k192792/ 2019-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k192792-trans1-axialif-plus-system-fda-510k.jpg K192792 - TranS1 AxiaLIF Plus System K192792 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Trans1. Cleared Nov 2019. https://www.510kdatabase.net/k192955/ 2019-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k192955-penumbra-lp-coil-system-fda-510k.jpg K192955 - Penumbra LP Coil System K192955 is a FDA 510(k) cleared neurology medical device. Manufacturer: Penumbra, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/den180062/ 2019-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/den180062-echotip-insight-portosystemic-pressure-fda-510k.jpg DEN180062 - EchoTip Insight Portosystemic Pressure Gradient Measuring System DEN180062 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Ireland, Ltd.. Cleared Nov 2019. https://www.510kdatabase.net/k182979/ 2019-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k182979-intellivue-patient-monitors-mx100-fda-510k.jpg K182979 - IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3 K182979 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Philips Medizin Systeme Boeblingen GmbH. Cleared Nov 2019. https://www.510kdatabase.net/k190816/ 2019-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k190816-vial-adapter-20-mm-vial-adapter-13-mm-fda-510k.jpg K190816 - Vial Adapter Ø20 mm , Vial Adapter Ø13 mm K190816 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Avenir Performance Europeenne Medical (Apem). Cleared Nov 2019. https://www.510kdatabase.net/k191278/ 2019-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k191278-rsi-mri-fda-510k.jpg K191278 - RSI-MRI+ K191278 is a FDA 510(k) cleared radiology medical device. Manufacturer: Multimodal Imaging Services Corporation (Dba Healthlytix). Cleared Nov 2019. https://www.510kdatabase.net/k192204/ 2019-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k192204-sensuva-strawberry-personal-lubricant-fda-510k.jpg K192204 - Sensuva Strawberry Personal Lubricant, Sensuva Apple Candy Personal Lubricant, Sensuva Butter Rum Personal Lubricant, Sensuva Orange Creamsicle Personal Lubricant, Sensuva Salted Caramel Personal Lubricant, K192204 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Valencia Naturals, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k192269/ 2019-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k192269-twinscan-808755-laser-system-fda-510k.jpg K192269 - TwinScan 808/755 Laser System K192269 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Gme (German Medical Engineering) GmbH. Cleared Nov 2019. https://www.510kdatabase.net/k192292/ 2019-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k192292-l10-led-light-source-with-aim-l11-led-fda-510k.jpg K192292 - L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight Cable K192292 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker. Cleared Nov 2019. https://www.510kdatabase.net/k192573/ 2019-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k192573-dolphin-medical-imaging-usb-ultrasound-fda-510k.jpg K192573 - Dolphin Medical Imaging USB Ultrasound System K192573 is a FDA 510(k) cleared radiology medical device. Manufacturer: Dolphin Medical Imaging, LLC. Cleared Nov 2019. https://www.510kdatabase.net/k192643/ 2019-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k192643-dannik-laparoscopic-suction-irrigation-fda-510k.jpg K192643 - Dannik Laparoscopic Suction Irrigation System K192643 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Dannik. Cleared Nov 2019. https://www.510kdatabase.net/k182732/ 2019-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k182732-jtl-250-01-fda-510k.jpg K182732 - JTL-250-01 K182732 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Jointechlabs, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k182917/ 2019-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k182917-fluorocal-fda-510k.jpg K182917 - FluoroCal K182917 is a FDA 510(k) cleared dental medical device. Manufacturer: Bisco, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k183393/ 2019-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k183393-digital-thermometer-fda-510k.jpg K183393 - Digital Thermometer K183393 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Joytech Healthcare Co. , Ltd.. Cleared Nov 2019. https://www.510kdatabase.net/k190797/ 2019-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k190797-reedgyn-disposable-hysteroscope-model-fda-510k.jpg K190797 - Reedgyn disposable hysteroscope (Model RH-2S-01 and Model RH-2D-01) K190797 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Reed Medical (Zhejiang) Co., Ltd.. Cleared Nov 2019. https://www.510kdatabase.net/k191980/ 2019-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k191980-clearfil-majesty-es-flow-fda-510k.jpg K191980 - CLEARFIL MAJESTY ES Flow K191980 is a FDA 510(k) cleared dental medical device. Manufacturer: Kuraray Noritake Dental, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k192323/ 2019-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k192323-polylock-small-bone-plating-system-fda-510k.jpg K192323 - PolyLock Small Bone Plating System K192323 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Fusion Orthopedics, LLC. Cleared Nov 2019. https://www.510kdatabase.net/k192769/ 2019-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k192769-impella-cp-introducer-fda-510k.jpg K192769 - Impella CP Introducer K192769 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abiomed, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k192937/ 2019-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k192937-3m-comply-hydrogen-peroxide-chemical-fda-510k.jpg K192937 - 3M Comply Hydrogen Peroxide Chemical Indicator K192937 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Nov 2019. https://www.510kdatabase.net/k182672/ 2019-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k182672-rosa-bracket-fda-510k.jpg K182672 - ROSA Bracket K182672 is a FDA 510(k) cleared dental medical device. Manufacturer: Gni Co., Ltd.. Cleared Nov 2019. https://www.510kdatabase.net/k183598/ 2019-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k183598-keyprint-keysplint-soft-fda-510k.jpg K183598 - KeyPrint KeySplint Soft K183598 is a FDA 510(k) cleared dental medical device. Manufacturer: Keystone Industries. Cleared Nov 2019. https://www.510kdatabase.net/k190312/ 2019-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k190312-dornier-ureteral-stent-fda-510k.jpg K190312 - Dornier Ureteral Stent K190312 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Dornier Medtech America, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k190391/ 2019-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k190391-tdm-plate-and-screw-systems-fda-510k.jpg K190391 - TDM Plate and Screw Systems K190391 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tdm Co., Ltd.. Cleared Nov 2019. https://www.510kdatabase.net/k190397/ 2019-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k190397-immunalysis-carisoprodol-metabolite-fda-510k.jpg K190397 - Immunalysis Carisoprodol Metabolite / Meprobamate Urine HEIA K190397 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Immunalysis Corporation. Cleared Nov 2019. https://www.510kdatabase.net/k191201/ 2019-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k191201-em-sa-implant-system-fda-510k.jpg K191201 - EM SA Implant System K191201 is a FDA 510(k) cleared dental medical device. Manufacturer: Hiossen, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k191247/ 2019-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k191247-smartspace-shoulder-system-fda-510k.jpg K191247 - SmartSPACE Shoulder System K191247 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Techmah Medical, LLC. Cleared Nov 2019. https://www.510kdatabase.net/k191701/ 2019-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k191701-arcus-head-fixation-frame-fda-510k.jpg K191701 - Arcus Head Fixation Frame K191701 is a FDA 510(k) cleared neurology medical device. Manufacturer: Mri Interventions, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k191784/ 2019-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k191784-gabriel-feeding-tube-with-balloon-and-fda-510k.jpg K191784 - Gabriel Feeding Tube with Balloon, and EnFit Connector K191784 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Syncro Medical Innovations, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k191921/ 2019-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k191921-cochlear-osia-osi200-implant-cochlear-fda-510k.jpg K191921 - Cochlear Osia OSI200 Implant, Cochlear Osia 2 Sound Processor, Osia Fitting Software 2.0, Osia SmartApp, Cochlear Osia Surgical Instruments K191921 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Cochlear Americas. Cleared Nov 2019. https://www.510kdatabase.net/k192045/ 2019-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k192045-ophthalmic-yag-laser-system-yc-200-fda-510k.jpg K192045 - Ophthalmic Yag Laser System YC-200 K192045 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Nidek Co., Ltd.. Cleared Nov 2019. https://www.510kdatabase.net/k192113/ 2019-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k192113-drsplus-fda-510k.jpg K192113 - DRSplus K192113 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Centervue S.P.A.. Cleared Nov 2019. https://www.510kdatabase.net/k192174/ 2019-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k192174-spy-portable-handheld-imaging-spy-phi-fda-510k.jpg K192174 - SPY Portable Handheld Imaging (SPY-PHI) System K192174 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Novadaq Technologies Ulc. (Now A Part of Stryker). Cleared Nov 2019. https://www.510kdatabase.net/k192245/ 2019-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k192245-pentax-medical-video-duodenoscope-ed34-fda-510k.jpg K192245 - Pentax Medical Video Duodenoscope ED34-i10T2 K192245 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Pentax of America, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k192289/ 2019-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k192289-irraflow-catheter-irraflow-tube-set-fda-510k.jpg K192289 - IRRAflow Catheter, IRRAflow Tube Set, IRRAflow Control Unit K192289 is a FDA 510(k) cleared neurology medical device. Manufacturer: Irras USA, Ltd.. Cleared Nov 2019. https://www.510kdatabase.net/k192842/ 2019-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k192842-hemotrol-duo-low-hemotrol-duo-normal-fda-510k.jpg K192842 - HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High K192842 is a FDA 510(k) cleared hematology medical device. Manufacturer: Eurotrol B.V.. Cleared Nov 2019. https://www.510kdatabase.net/k192935/ 2019-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k192935-capere-thrombectomy-system-fda-510k.jpg K192935 - CAPERE Thrombectomy System K192935 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vascular Medcure, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k192936/ 2019-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k192936-soltus-500-fda-510k.jpg K192936 - Soltus 500 K192936 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sedecal., Sa.. Cleared Nov 2019. https://www.510kdatabase.net/k192940/ 2019-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k192940-cooltone-fda-510k.jpg K192940 - CoolTone K192940 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zimmer Medizinsysteme GmbH. Cleared Nov 2019. https://www.510kdatabase.net/k183666/ 2019-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k183666-eba-one-nailing-system-fda-510k.jpg K183666 - EBA One Nailing System K183666 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Citieffe S.R.L.. Cleared Nov 2019. https://www.510kdatabase.net/k190478/ 2019-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k190478-reprocessed-viewflex-xtra-ice-catheter-fda-510k.jpg K190478 - Reprocessed ViewFlex™ Xtra ICE Catheter K190478 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sterilmed, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k190522/ 2019-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k190522-allwin-intra-uterine-insemination-fda-510k.jpg K190522 - Allwin Intra Uterine Insemination Catheters (INSEMINA and INSEMINA Open Tip Intra Uterine Insemination Catheter, CURVED and CURVED Open Tip Intra Uterine Insemination Catheter, TRACKABLE and TRACKABLE Open Tip Intra Uterine Insemination Catheter, FLEXI and FLEXI Open Tip Intra Uterine Insemination Catheter, STUMPY Intra Uterine Insemination Catheter) K190522 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Allwin Medical Devices, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k190721/ 2019-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k190721-longbow-ti-fda-510k.jpg K190721 - LongBow Ti K190721 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k191110/ 2019-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k191110-herabeat-us-fda-510k.jpg K191110 - HeraBEAT™ US K191110 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Heramed, Ltd.. Cleared Nov 2019. https://www.510kdatabase.net/k191280/ 2019-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k191280-e-100-electrosurgical-generator-fda-510k.jpg K191280 - E-100 Electrosurgical Generator, SynchroSeal K191280 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k192347/ 2019-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k192347-st-internal-implant-system-fda-510k.jpg K192347 - ST Internal Implant System K192347 is a FDA 510(k) cleared dental medical device. Manufacturer: Megagen Implant Co., Ltd.. Cleared Nov 2019. https://www.510kdatabase.net/k192355/ 2019-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k192355-microscan-dried-gram-negative-miccombo-fda-510k.jpg K192355 - MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32ug/mL) K192355 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k192908/ 2019-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k192908-fusion-cytology-brush-cytomax-ii-fda-510k.jpg K192908 - Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes K192908 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Wilson-Cook Medical, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k192911/ 2019-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k192911-brainlab-compatible-k2m-navigation-fda-510k.jpg K192911 - Brainlab Compatible K2M Navigation Instruments K192911 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: K2m, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k191171/ 2019-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k191171-echogo-core-fda-510k.jpg K191171 - EchoGo Core K191171 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ultromics, Ltd.. Cleared Nov 2019. https://www.510kdatabase.net/k191477/ 2019-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k191477-aeon-c-stand-alone-system-fda-510k.jpg K191477 - AEON-C Stand Alone System K191477 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Huvexel Co. , Ltd.. Cleared Nov 2019. https://www.510kdatabase.net/k191570/ 2019-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k191570-infrared-thermometer-model-md-h30-fda-510k.jpg K191570 - Infrared Thermometer Model MD-H30 K191570 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Guangzhou Berrcom Medical Device Co., Ltd.. Cleared Nov 2019. https://www.510kdatabase.net/k191976/ 2019-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k191976-piper-go-io-intraosseous-infusion-system-fda-510k.jpg K191976 - Piper GO-IO Intraosseous Infusion System K191976 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Piper Access, LLC. Cleared Nov 2019. https://www.510kdatabase.net/k192150/ 2019-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k192150-amicus-separator-system-fda-510k.jpg K192150 - AMICUS Separator System K192150 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fresenius Kabi AG. Cleared Nov 2019. https://www.510kdatabase.net/k192469/ 2019-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k192469-nox-sleep-system-fda-510k.jpg K192469 - Nox Sleep System K192469 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nox Medical. Cleared Nov 2019. https://www.510kdatabase.net/k192582/ 2019-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k192582-nuvasive-coroent-small-interlock-system-fda-510k.jpg K192582 - NuVasive CoRoent Small Interlock System K192582 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Nov 2019. https://www.510kdatabase.net/k192915/ 2019-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k192915-gma-20-pedicle-screw-system-fda-510k.jpg K192915 - GMA 2.0 Pedicle Screw System K192915 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Grafton Medical Alliance. Cleared Nov 2019. https://www.510kdatabase.net/k190799/ 2019-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k190799-pentax-medical-video-upper-gi-scopes-fda-510k.jpg K190799 - PENTAX Medical Video Upper GI Scopes (EG Family) K190799 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Pentax of America, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k191161/ 2019-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k191161-xtag-gastrointestinal-pathogen-panel-gpp-fda-510k.jpg K191161 - xTAG Gastrointestinal Pathogen Panel (GPP) K191161 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Luminex Molecular Diagnostics, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k191972/ 2019-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k191972-arix-wrist-system-fda-510k.jpg K191972 - ARIX Wrist System K191972 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Jeil Medical Corporation. Cleared Nov 2019. https://www.510kdatabase.net/k192202/ 2019-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k192202-clear21-fda-510k.jpg K192202 - Clear21 K192202 is a FDA 510(k) cleared dental medical device. Manufacturer: World Class Technology Corporation. Cleared Nov 2019. https://www.510kdatabase.net/k192238/ 2019-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k192238-ac3-series-intra-aortic-balloon-pump-fda-510k.jpg K192238 - AC3 Series Intra-Aortic Balloon Pump (IABP) K192238 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Arrow International, Teleflex. Cleared Nov 2019. https://www.510kdatabase.net/k192331/ 2019-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k192331-lasemd-leo-laser-system-fda-510k.jpg K192331 - LaseMD LEO Laser System K192331 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lutronic Global. Cleared Nov 2019. https://www.510kdatabase.net/k192932/ 2019-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k192932-fdr-d-evo-iii-flat-panel-detector-system-fda-510k.jpg K192932 - FDR D-EVO III flat panel detector system K192932 is a FDA 510(k) cleared radiology medical device. Manufacturer: Fujifilm Corporation. Cleared Nov 2019. https://www.510kdatabase.net/k192968/ 2019-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k192968-identify-fda-510k.jpg K192968 - IDENTIFY K192968 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k191986/ 2019-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k191986-dess-dental-smart-solutions-fda-510k.jpg K191986 - DESS Dental Smart Solutions K191986 is a FDA 510(k) cleared dental medical device. Manufacturer: Terrats Medical SL. Cleared Nov 2019. https://www.510kdatabase.net/k192661/ 2019-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k192661-latera-absorbable-nasal-implant-system-fda-510k.jpg K192661 - LATERA Absorbable Nasal Implant System K192661 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Entellus Medical, Inc. (Aka Stryker Ent). Cleared Nov 2019. https://www.510kdatabase.net/k190661/ 2019-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k190661-omics-core-fda-510k.jpg K190661 - Omics Core K190661 is a FDA 510(k) cleared pathology medical device. Manufacturer: Nanthealth, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k190958/ 2019-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k190958-neodent-implant-system-fda-510k.jpg K190958 - Neodent Implant System K190958 is a FDA 510(k) cleared dental medical device. Manufacturer: Jjgc Industria E Comercio DE Materiais Dentarios S.A.. Cleared Nov 2019. https://www.510kdatabase.net/k182301/ 2019-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k182301-pfc-sigma-knee-system-fda-510k.jpg K182301 - PFC SIGMA Knee System K182301 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k190998/ 2019-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k190998-ba-pit-fissure-sealant-fda-510k.jpg K190998 - BA Pit & Fissure Sealant K190998 is a FDA 510(k) cleared dental medical device. Manufacturer: Apex Dental Materials, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k191230/ 2019-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k191230-halyard-sterling-nitrile-powder-free-fda-510k.jpg K191230 - Halyard Sterling* Nitrile Powder-Free Exam Gloves, Halyard Sterling SG* Nitrile Sensi-Guard Powder-Free Exam Gloves K191230 is a FDA 510(k) cleared general hospital medical device. Manufacturer: O&M Halyard, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k191237/ 2019-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k191237-cerenovus-large-bore-catheter-fda-510k.jpg K191237 - CERENOVUS Large Bore Catheter K191237 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k191282/ 2019-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k191282-pentax-medical-epk-i7010-and-pentax-fda-510k.jpg K191282 - PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family K191282 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Pentax of America, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k191286/ 2019-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k191286-contour-next-blood-glucose-monitoring-fda-510k.jpg K191286 - CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose Monitoring System, CONTOUR® NEXT ONE Blood Glucose Monitoring System, CONTOUR® NEXT EZ Blood Glucose Monitoring System, CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System K191286 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Ascensia Diabetes Care. Cleared Nov 2019. https://www.510kdatabase.net/k191527/ 2019-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k191527-visalys-cemcore-visalys-cem-core-try-fda-510k.jpg K191527 - Visalys CemCore, Visalys Cem Core Try In Paste K191527 is a FDA 510(k) cleared dental medical device. Manufacturer: Kettenbach GmbH & Co. KG. Cleared Nov 2019. https://www.510kdatabase.net/k191959/ 2019-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k191959-quantx-breast-mri-biopsy-guidance-plugin-fda-510k.jpg K191959 - QuantX Breast MRI Biopsy Guidance Plugin K191959 is a FDA 510(k) cleared radiology medical device. Manufacturer: Qlarity Imaging. Cleared Nov 2019. https://www.510kdatabase.net/k192019/ 2019-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k192019-dragonfly-opstar-imaging-catheter-fda-510k.jpg K192019 - Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1 K192019 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared Nov 2019. https://www.510kdatabase.net/k192049/ 2019-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k192049-oryx-cervical-plate-system-fda-510k.jpg K192049 - Oryx Cervical Plate System K192049 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Innovasis, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k192118/ 2019-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k192118-crp-vario-fda-510k.jpg K192118 - CRP Vario K192118 is a FDA 510(k) cleared immunology medical device. Manufacturer: SENTINEL CH. SpA. Cleared Nov 2019. https://www.510kdatabase.net/k192232/ 2019-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k192232-nitrile-powder-free-examination-glove-fda-510k.jpg K192232 - Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (White) K192232 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hartalega NGC Sdn. Bhd.. Cleared Nov 2019. https://www.510kdatabase.net/k192264/ 2019-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k192264-hivox-spopad-ems-sp-911-sp-921-fda-510k.jpg K192264 - HIVOX Spopad EMS SP-911, SP-921 K192264 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Hivox Biotek, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k192297/ 2019-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k192297-aptus-wrist-arthrodesis-plates-fda-510k.jpg K192297 - APTUS Wrist Arthrodesis Plates K192297 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medartis AG. Cleared Nov 2019. https://www.510kdatabase.net/k192403/ 2019-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k192403-vk100-percutaneous-vertebral-fda-510k.jpg K192403 - VK100 Percutaneous Vertebral Augmentation System K192403 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Bonwrx, Ltd.. Cleared Nov 2019. https://www.510kdatabase.net/k192432/ 2019-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k192432-ipl-home-use-hair-removal-device-fda-510k.jpg K192432 - IPL Home Use Hair Removal Device Model(s): D-1128, D-1103, D-1119, D-1129, D-1130 K192432 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Bosidin Technology Co., Ltd.. Cleared Nov 2019. https://www.510kdatabase.net/k192819/ 2019-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k192819-oec-elite-fda-510k.jpg K192819 - OEC Elite K192819 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Oec Medical Systems, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k190571/ 2019-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k190571-stonebite-and-stonebite-scan-fda-510k.jpg K190571 - StoneBite and StoneBite scan K190571 is a FDA 510(k) cleared dental medical device. Manufacturer: Dreve Dentamid GmbH. Cleared Nov 2019. https://www.510kdatabase.net/k190872/ 2019-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k190872-biogenesis-fertility-lubricant-fda-510k.jpg K190872 - BioGenesis Fertility Lubricant K190872 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Good Clean Love, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k190923/ 2019-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k190923-salem-sump-dual-lumen-stomach-tube-fda-510k.jpg K190923 - Salem Sump Dual Lumen Stomach Tube with ENFit Connection K190923 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cardinalhealth. Cleared Nov 2019. https://www.510kdatabase.net/k191026/ 2019-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k191026-medip-pro-fda-510k.jpg K191026 - MEDIP PRO K191026 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medical IP Co., Ltd.. Cleared Nov 2019. https://www.510kdatabase.net/k191361/ 2019-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k191361-demediox-barbed-absorbable-surgical-fda-510k.jpg K191361 - DemeDIOX Barbed Absorbable Surgical Suture K191361 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Demetech Corporation. Cleared Nov 2019. https://www.510kdatabase.net/k191466/ 2019-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k191466-sandshark-injectable-anchor-sia-system-fda-510k.jpg K191466 - SandShark Injectable Anchor (SIA) System K191466 is a FDA 510(k) cleared neurology medical device. Manufacturer: Stimwave Technologies, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k191564/ 2019-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k191564-progenikine-concentrating-system-25-ml-fda-510k.jpg K191564 - Progenikine Concentrating System 25 mL System K191564 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Emcyte Corporation. Cleared Nov 2019. https://www.510kdatabase.net/k192153/ 2019-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k192153-portux-cadcam-disc-fda-510k.jpg K192153 - Portux CAD/CAM Disc K192153 is a FDA 510(k) cleared dental medical device. Manufacturer: New Stetic, SA. Cleared Nov 2019. https://www.510kdatabase.net/k192181/ 2019-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k192181-precice-plating-system-fda-510k.jpg K192181 - PRECICE Plating System K192181 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nuvasive Specialized Orthopedics, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k192327/ 2019-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k192327-depuy-synthes-24mm-lcp-straight-wrist-fda-510k.jpg K192327 - DePuy Synthes 2.4mm LCP Straight Wrist Plate, Sterile K192327 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes USA Products, LLC. Cleared Nov 2019. https://www.510kdatabase.net/k192632/ 2019-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k192632-digital-radiography-cxdi-702c-wireless-fda-510k.jpg K192632 - DIGITAL RADIOGRAPHY CXDI-702C Wireless, DIGITAL RADIOGRAPHY CXDI-402C Wireless K192632 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k192871/ 2019-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k192871-b-anthracis-real-time-pcr-assay-fda-510k.jpg K192871 - B. anthracis Real-time PCR Assay K192871 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Centers For Disease Control and Prevention. Cleared Nov 2019. https://www.510kdatabase.net/k192891/ 2019-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k192891-laparoscope-lens-shield-device-lens-fda-510k.jpg K192891 - Laparoscope Lens Shield Device (LENS) K192891 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medeon Biodesign, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k192948/ 2019-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k192948-elevation-breast-biopsy-driver-fda-510k.jpg K192948 - EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G K192948 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bard Peripheral Vascular, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k182463/ 2019-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k182463-silicone-foley-catheter-fda-510k.jpg K182463 - Silicone Foley Catheter K182463 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Biosensors International Pte, Ltd.. Cleared Nov 2019. https://www.510kdatabase.net/k182929/ 2019-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k182929-bio-ray-a-1-anchor-screw-system-fda-510k.jpg K182929 - BIO-RAY A-1 Anchor Screw System K182929 is a FDA 510(k) cleared dental medical device. Manufacturer: Microware Precision Co., Ltd.. Cleared Nov 2019. https://www.510kdatabase.net/k190003/ 2019-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k190003-vivid-aligners-fda-510k.jpg K190003 - Vivid Aligners K190003 is a FDA 510(k) cleared dental medical device. Manufacturer: Orthodent Laboratory, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k190268/ 2019-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k190268-hydrofera-blue-ready-border-fda-510k.jpg K190268 - Hydrofera Blue READY - Border K190268 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Hydrofera, LLC. Cleared Nov 2019. https://www.510kdatabase.net/k190335/ 2019-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k190335-gsp-neonatal-total-galactose-kit-fda-510k.jpg K190335 - GSP Neonatal Total Galactose kit K190335 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Perkinelmer, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k191651/ 2019-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k191651-arthrex-nano-swivelock-suture-anchor-fda-510k.jpg K191651 - Arthrex Nano SwiveLock Suture Anchor K191651 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k191891/ 2019-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k191891-somatom-xcite-fda-510k.jpg K191891 - SOMATOM X.cite K191891 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k191914/ 2019-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k191914-thermo-scientific-sensititre-aris-hiq-fda-510k.jpg K191914 - Thermo Scientific Sensititre ARIS HiQ System K191914 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Thermo Fisher Scientific. Cleared Nov 2019. https://www.510kdatabase.net/k191918/ 2019-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k191918-thermo-scientific-sensititre-aris-hiq-fda-510k.jpg K191918 - Thermo Scientific Sensititre ARIS HiQ System K191918 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Thermo Fisher Scientific. Cleared Nov 2019. https://www.510kdatabase.net/k192198/ 2019-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k192198-conformis-hip-system-fda-510k.jpg K192198 - Conformis Hip System K192198 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Conformis, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k192729/ 2019-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k192729-sensititre-18-24-hour-mic-or-fda-510k.jpg K192729 - Sensititre 18-24 Hour MIC or Breakpoint Susceptibility System with Lefamulin in the dilution range of 0.008-16ug/ml K192729 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Thermo Fisher Scientific. Cleared Nov 2019. https://www.510kdatabase.net/k183457/ 2019-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k183457-zimmer-biomet-1214-cocr-femoral-head-fda-510k.jpg K183457 - Zimmer Biomet 12/14 CoCr Femoral Head and Freedom Head K183457 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k190144/ 2019-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k190144-mucopeg-fda-510k.jpg K190144 - MucoPEG K190144 is a FDA 510(k) cleared dental medical device. Manufacturer: Sunbio, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k190225/ 2019-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k190225-tap-blood-collection-device-fda-510k.jpg K190225 - TAP Blood Collection Device K190225 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Seventh Sense Biosystems, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k190541/ 2019-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k190541-mts225-and-mts300-multiple-tray-fda-510k.jpg K190541 - MTS225 and MTS300 Multiple Tray Sterilization Systems K190541 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Pmbs, LLC. Cleared Nov 2019. https://www.510kdatabase.net/k190868/ 2019-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k190868-cleerly-labs-fda-510k.jpg K190868 - Cleerly Labs K190868 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cleerly, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k191047/ 2019-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k191047-adi-tidal-osteotomy-wedge-fda-510k.jpg K191047 - ADI TiDAL Osteotomy Wedge K191047 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Additive Device, Inc. (Adi) D/B/A Restor3D. Cleared Nov 2019. https://www.510kdatabase.net/k191292/ 2019-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k191292-powder-free-vinyl-patient-examination-fda-510k.jpg K191292 - Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) K191292 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Anhui Powerguard Technology Co., Ltd.. Cleared Nov 2019. https://www.510kdatabase.net/k192080/ 2019-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k192080-iassist-knee-system-fda-510k.jpg K192080 - iASSIST Knee System K192080 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthosoft Inc. (d/b/a) Zimmer CAS. Cleared Nov 2019. https://www.510kdatabase.net/k192109/ 2019-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k192109-koala-fda-510k.jpg K192109 - KOALA K192109 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ib Lab GmbH. Cleared Nov 2019. https://www.510kdatabase.net/k192140/ 2019-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k192140-7d-surgical-system-fda-510k.jpg K192140 - 7D Surgical System K192140 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 7D Surgical, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k192236/ 2019-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k192236-fitmore-hip-stem-fda-510k.jpg K192236 - Fitmore Hip Stem K192236 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer GmbH. Cleared Nov 2019. https://www.510kdatabase.net/k192858/ 2019-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k192858-a1at-genotyping-test-fda-510k.jpg K192858 - A1AT Genotyping Test K192858 is a FDA 510(k) cleared immunology medical device. Manufacturer: Progenika Biopharma S.A., A Grifols Company. Cleared Nov 2019. https://www.510kdatabase.net/k192992/ 2019-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k192992-suglue-3-fda-510k.jpg K192992 - Suglue 3 K192992 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Deutschland GmbH. Cleared Nov 2019. https://www.510kdatabase.net/k190013/ 2019-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k190013-welldoc-bluestar-fda-510k.jpg K190013 - WellDoc BlueStar K190013 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Welldoc, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k190143/ 2019-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k190143-lars-ac-band-device-fda-510k.jpg K190143 - LARS AC Band Device K190143 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corin USA. Cleared Nov 2019. https://www.510kdatabase.net/k190330/ 2019-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k190330-drx-evolutionplus-with-dual-energy-fda-510k.jpg K190330 - DRX-Evolution/Plus with Dual Energy K190330 is a FDA 510(k) cleared radiology medical device. Manufacturer: Carestream Health, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k190608/ 2019-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k190608-mei-ceramic-bracket-fda-510k.jpg K190608 - Mei Ceramic Bracket K190608 is a FDA 510(k) cleared dental medical device. Manufacturer: Orthosun Co., Ltd.. Cleared Nov 2019. https://www.510kdatabase.net/k191160/ 2019-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k191160-xtag-gastrointestinal-pathogen-panel-fda-510k.jpg K191160 - xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) K191160 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Luminex Molecular Diagnostics, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k191304/ 2019-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k191304-ethanzir-zirconia-fda-510k.jpg K191304 - EthanZir Zirconia K191304 is a FDA 510(k) cleared dental medical device. Manufacturer: Besorah Dental Solutions NZ Limited. Cleared Nov 2019. https://www.510kdatabase.net/k191634/ 2019-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k191634-scan-abutments-and-comfort-caps-fda-510k.jpg K191634 - Scan Abutments and Comfort Caps K191634 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentium Co., Ltd.. Cleared Nov 2019. https://www.510kdatabase.net/k192125/ 2019-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k192125-isolator-transpolar-pen-isolator-long-fda-510k.jpg K192125 - Isolator Transpolar Pen, Isolator Long Pen TT, Isolator Linear Pen K192125 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: AtriCure, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k192168/ 2019-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k192168-idys-alif-zp-3dti-fda-510k.jpg K192168 - Idys ALIF ZP 3DTi K192168 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Clariance, Sas. Cleared Nov 2019. https://www.510kdatabase.net/k191974/ 2019-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k191974-nuvasive-attrax-putty-fda-510k.jpg K191974 - NuVasive AttraX Putty K191974 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Nov 2019. https://www.510kdatabase.net/k183465/ 2019-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k183465-allcem-allcem-core-fda-510k.jpg K183465 - Allcem, Allcem Core K183465 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentscare Ltda. Cleared Nov 2019. https://www.510kdatabase.net/k192824/ 2019-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k192824-parcus-knotless-ap-suture-anchors-fda-510k.jpg K192824 - Parcus Knotless AP Suture Anchors K192824 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Parcus Medical, LLC. Cleared Nov 2019. https://www.510kdatabase.net/k181993/ 2019-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k181993-sturdy-autoclave-super-microm-models-fda-510k.jpg K181993 - STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) K181993 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sturdy Industrial Co., Ltd.. Cleared Nov 2019. https://www.510kdatabase.net/k183018/ 2019-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k183018-vpro5-fda-510k.jpg K183018 - VPro5 K183018 is a FDA 510(k) cleared dental medical device. Manufacturer: Propel Orthodontics, LLC. Cleared Nov 2019. https://www.510kdatabase.net/k190119/ 2019-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k190119-foryou-npwt-dressing-kit-fda-510k.jpg K190119 - Foryou NPWT Dressing Kit K190119 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 4l Health Co., Ltd.. Cleared Nov 2019. https://www.510kdatabase.net/k190189/ 2019-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k190189-mdt2-ble-self-monitoring-blood-glucose-fda-510k.jpg K190189 - MDT2 BLE Self-Monitoring Blood Glucose System K190189 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eps Bio Technology Corp.. Cleared Nov 2019. https://www.510kdatabase.net/k190190/ 2019-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k190190-wv1-endoscope-fda-510k.jpg K190190 - WV1 Endoscope K190190 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: 270surgical , Ltd.. Cleared Nov 2019. https://www.510kdatabase.net/k190334/ 2019-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k190334-mimosa-imager-fda-510k.jpg K190334 - MIMOSA Imager K190334 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Mimosa Diagnostics, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k190344/ 2019-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k190344-depuy-corail-amt-hip-prosthesis-fda-510k.jpg K190344 - DePuy Corail AMT Hip Prosthesis K190344 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy(Ireland). Cleared Nov 2019. https://www.510kdatabase.net/k190544/ 2019-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k190544-xihpos-zfuze-interbody-fusion-system-fda-510k.jpg K190544 - XIHPOS™ ZFUZE™ Interbody Fusion System K190544 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Difusion Technologies. Cleared Nov 2019. https://www.510kdatabase.net/k190855/ 2019-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k190855-bd-acute-central-line-fda-510k.jpg K190855 - BD Acute Central Line K190855 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bard Access Systems, Inc. (Bard Has Joined Bd). Cleared Nov 2019. https://www.510kdatabase.net/k190898/ 2019-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k190898-sight-olo-fda-510k.jpg K190898 - Sight OLO K190898 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sight Diagnostics , Ltd.. Cleared Nov 2019. https://www.510kdatabase.net/k191016/ 2019-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k191016-copal-exchange-g-hip-and-knee-spacers-fda-510k.jpg K191016 - COPAL exchange G Hip and Knee Spacers K191016 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Heraeus Medical GmbH. Cleared Nov 2019. https://www.510kdatabase.net/k191312/ 2019-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k191312-perfect-pfe-fda-510k.jpg K191312 - Perfect PFE K191312 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Tenscare, Ltd.. Cleared Nov 2019. https://www.510kdatabase.net/k191497/ 2019-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k191497-nextdent-denture-3d-fda-510k.jpg K191497 - NextDent Denture 3D+ K191497 is a FDA 510(k) cleared dental medical device. Manufacturer: Vertex-Dental B.V.. Cleared Nov 2019. https://www.510kdatabase.net/k191597/ 2019-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k191597-stealth-autoguide-system-midas-rex-fda-510k.jpg K191597 - Stealth Autoguide System, Midas Rex Legend Depth Stop System K191597 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Navigation, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k191622/ 2019-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k191622-delta-multihole-tt-pro-acetabular-system-fda-510k.jpg K191622 - Delta Multihole TT Pro Acetabular System K191622 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Lima Corporate S.P.A.. Cleared Nov 2019. https://www.510kdatabase.net/k191631/ 2019-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k191631-zmaxx-dental-zirconia-blanks-fda-510k.jpg K191631 - ZMAXX Dental Zirconia Blanks K191631 is a FDA 510(k) cleared dental medical device. Manufacturer: Zmaxx Bioceramics, LLC. Cleared Nov 2019. https://www.510kdatabase.net/k191650/ 2019-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k191650-legion-system-fda-510k.jpg K191650 - LEGION System K191650 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Alcon Research, LLC. Cleared Nov 2019. https://www.510kdatabase.net/k191693/ 2019-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k191693-bc-5-fda-510k.jpg K191693 - BC-5 K191693 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Reveallux, Corp. Cleared Nov 2019. https://www.510kdatabase.net/k192087/ 2019-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k192087-combo-electrotherapy-device-fda-510k.jpg K192087 - Combo Electrotherapy Device K192087 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Roundwhale Technology Co. , Ltd.. Cleared Nov 2019. https://www.510kdatabase.net/k192095/ 2019-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k192095-capi-3-immunotyping-capillarys-3-tera-fda-510k.jpg K192095 - CAPI 3 Immunotyping, Capillarys 3 Tera K192095 is a FDA 510(k) cleared immunology medical device. Manufacturer: Sebia. Cleared Nov 2019. https://www.510kdatabase.net/k192117/ 2019-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k192117-small-vbr-fda-510k.jpg K192117 - Small VBR™ K192117 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ulrich GmbH & Co. KG. Cleared Nov 2019. https://www.510kdatabase.net/k192278/ 2019-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k192278-luminelle-dtx-hysteroscopy-system-fda-510k.jpg K192278 - Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic) K192278 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Uvision360, Inc.. Cleared Nov 2019. https://www.510kdatabase.net/k192440/ 2019-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k192440-fdr-se-lite-fda-510k.jpg K192440 - FDR SE Lite K192440 is a FDA 510(k) cleared radiology medical device. Manufacturer: Fujifilm Corporation. Cleared Nov 2019. https://www.510kdatabase.net/k183412/ 2019-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k183412-medicad-web-fda-510k.jpg K183412 - mediCAD Web K183412 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medicad Hectec GmbH. Cleared Oct 2019. https://www.510kdatabase.net/k190047/ 2019-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k190047-stimrouter-neuromodulation-system-fda-510k.jpg K190047 - StimRouter Neuromodulation System K190047 is a FDA 510(k) cleared neurology medical device. Manufacturer: Bioness, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k190281/ 2019-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k190281-ultrasonic-surgical-system-fda-510k.jpg K190281 - Ultrasonic Surgical System K190281 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medisonic Technology CO. Cleared Oct 2019. https://www.510kdatabase.net/k190747/ 2019-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k190747-claritag-fda-510k.jpg K190747 - Claritag K190747 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Dgi Technologies. Cleared Oct 2019. https://www.510kdatabase.net/k191002/ 2019-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k191002-or3o-dual-mobility-system-fda-510k.jpg K191002 - OR3O Dual Mobility System K191002 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k191769/ 2019-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k191769-epm-series-patient-monitors-fda-510k.jpg K191769 - ePM Series Patient monitors K191769 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Oct 2019. https://www.510kdatabase.net/k191896/ 2019-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k191896-belimed-steam-sterilizer-mst-h-top-5000-fda-510k.jpg K191896 - Belimed Steam Sterilizer MST-H TOP 5000 K191896 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Belimed AG. Cleared Oct 2019. https://www.510kdatabase.net/k192110/ 2019-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k192110-vitek-densichek-fda-510k.jpg K192110 - Vitek Densichek K192110 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k192345/ 2019-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k192345-mts-ampicillin-sulbactam-00160008-fda-510k.jpg K192345 - MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL K192345 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Liofilchem S. R. L.. Cleared Oct 2019. https://www.510kdatabase.net/k192525/ 2019-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k192525-087-balloon-guide-catheter-system-fda-510k.jpg K192525 - 087 Balloon Guide Catheter System K192525 is a FDA 510(k) cleared neurology medical device. Manufacturer: Q'Apel Medical, LLC. Cleared Oct 2019. https://www.510kdatabase.net/k192743/ 2019-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k192743-visionx-24-fda-510k.jpg K192743 - VisionX 2.4 K192743 is a FDA 510(k) cleared radiology medical device. Manufacturer: Durr Dental SE. Cleared Oct 2019. https://www.510kdatabase.net/k192867/ 2019-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k192867-apyx-helium-plasma-generator-apyx-fda-510k.jpg K192867 - Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3) K192867 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bovie Medical Corporation Dba Apyx Medical Corporation. Cleared Oct 2019. https://www.510kdatabase.net/k192961/ 2019-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k192961-adh19-fda-510k.jpg K192961 - ADH19 K192961 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Deutschland GmbH. Cleared Oct 2019. https://www.510kdatabase.net/k190267/ 2019-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k190267-eze-sit-valvulotome-fda-510k.jpg K190267 - EZE SIT Valvulotome K190267 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Lemaitre Vascular. Cleared Oct 2019. https://www.510kdatabase.net/k190921/ 2019-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k190921-arthrex-low-profile-screws-fda-510k.jpg K190921 - Arthrex Low Profile Screws K190921 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k191134/ 2019-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k191134-ib3d-alif-fda-510k.jpg K191134 - IB3D ALIF K191134 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medicrea International SA. Cleared Oct 2019. https://www.510kdatabase.net/k191170/ 2019-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k191170-reprocessed-reflexion-spiral-bi-fda-510k.jpg K191170 - Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology Catheter K191170 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Innovative Health, LLC. Cleared Oct 2019. https://www.510kdatabase.net/k191264/ 2019-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k191264-every-second-matters-uterine-balloon-fda-510k.jpg K191264 - Every Second Matters-Uterine Balloon Tamponade (“ESM-UBT”) K191264 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ujenzi Charitable Trust. Cleared Oct 2019. https://www.510kdatabase.net/k192083/ 2019-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k192083-okami-medical-lobo-vascular-occlusion-fda-510k.jpg K192083 - Okami Medical LOBO Vascular Occlusion System K192083 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Okami Medical. Cleared Oct 2019. https://www.510kdatabase.net/k192504/ 2019-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k192504-treace-medical-concepts-tmc-plating-fda-510k.jpg K192504 - Treace Medical Concepts (TMC) Plating System K192504 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Treace Medical Concepts, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k192775/ 2019-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k192775-niobe-magnetic-navigation-system-mns-fda-510k.jpg K192775 - Niobe® Magnetic Navigation System (MNS) with Navigant Workstation (NWS) and Cardiodri K192775 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Stereotaxis, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k192783/ 2019-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k192783-aristotle-24-guidewire-200cm-soft-fda-510k.jpg K192783 - Aristotle 24 Guidewire, 200cm, Soft Profile K192783 is a FDA 510(k) cleared neurology medical device. Manufacturer: Scientia Vascular, LLC. Cleared Oct 2019. https://www.510kdatabase.net/k192790/ 2019-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k192790-atellica-im-total-hcg-thcg-fda-510k.jpg K192790 - Atellica IM Total hCG (ThCG) K192790 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k191385/ 2019-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k191385-brilliant-componeer-fda-510k.jpg K191385 - BRILLIANT COMPONEER K191385 is a FDA 510(k) cleared dental medical device. Manufacturer: Coltene/Whaledent AG. Cleared Oct 2019. https://www.510kdatabase.net/k191855/ 2019-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k191855-emface-device-fda-510k.jpg K191855 - EmFace Device K191855 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Inmode MD , Ltd.. Cleared Oct 2019. https://www.510kdatabase.net/k191862/ 2019-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k191862-compression-therapy-device-model-lgt-fda-510k.jpg K191862 - Compression Therapy Device Model LGT-2200SP K191862 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Guangzhou Longest Science & Technology Co., Ltd.. Cleared Oct 2019. https://www.510kdatabase.net/k191925/ 2019-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k191925-matrx-plus-fda-510k.jpg K191925 - MATRx Plus K191925 is a FDA 510(k) cleared dental medical device. Manufacturer: Zephyr Sleep Technologies. Cleared Oct 2019. https://www.510kdatabase.net/k192041/ 2019-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k192041-g21-spaceflex-hip-fda-510k.jpg K192041 - G21 SpaceFlex Hip K192041 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: G21, S.R.L.. Cleared Oct 2019. https://www.510kdatabase.net/k192053/ 2019-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k192053-w-zirconia-implants-fda-510k.jpg K192053 - W Zirconia Implants K192053 is a FDA 510(k) cleared dental medical device. Manufacturer: Tav Medical , Ltd.. Cleared Oct 2019. https://www.510kdatabase.net/k192114/ 2019-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k192114-game-ready-grpro-21-system-fda-510k.jpg K192114 - Game Ready GRPro 2.1 System K192114 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Cool Systems, Inc. (Dba Game Ready). Cleared Oct 2019. https://www.510kdatabase.net/k192121/ 2019-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k192121-black-diamond-pedicle-screw-system-fda-510k.jpg K192121 - Black Diamond Pedicle Screw System K192121 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osseus Fusion Systems. Cleared Oct 2019. https://www.510kdatabase.net/k192133/ 2019-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k192133-zimmer-biomet-universal-navigation-fda-510k.jpg K192133 - Zimmer Biomet Universal Navigation System K192133 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer Biomet Spine, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k192173/ 2019-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k192173-rosa-one-spine-application-fda-510k.jpg K192173 - ROSA ONE Spine application K192173 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtech S.A. Cleared Oct 2019. https://www.510kdatabase.net/k192369/ 2019-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k192369-pixotest-poct-system-pixotest-poct-fda-510k.jpg K192369 - PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit K192369 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Ixensor Co, Ltd.. Cleared Oct 2019. https://www.510kdatabase.net/k192494/ 2019-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k192494-nexgen-anterior-cervical-plate-system-fda-510k.jpg K192494 - NexGen Anterior Cervical Plate System K192494 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Precision Spine. Cleared Oct 2019. https://www.510kdatabase.net/k180347/ 2019-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k180347-3d-cage-fda-510k.jpg K180347 - 3d Cage K180347 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Fims Co., Ltd.. Cleared Oct 2019. https://www.510kdatabase.net/k182605/ 2019-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k182605-hs-amica-devices-family-fda-510k.jpg K182605 - HS AMICA devices family K182605 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: H.S Hospital Service S.P.A. Cleared Oct 2019. https://www.510kdatabase.net/k191881/ 2019-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k191881-kbl-7000-alpha-hybridsun-kbl-7900-fda-510k.jpg K191881 - KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun K191881 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Kbl GmbH. Cleared Oct 2019. https://www.510kdatabase.net/k192029/ 2019-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k192029-straumann-pureloc-abutments-fda-510k.jpg K192029 - Straumann PUREloc abutments K192029 is a FDA 510(k) cleared dental medical device. Manufacturer: Institut Straumann AG. Cleared Oct 2019. https://www.510kdatabase.net/k192046/ 2019-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k192046-liaison-xl-zika-capture-igm-ii-and-fda-510k.jpg K192046 - LIAISON XL Zika Capture IgM II and LIAISON XL Zika Capture IgM II Control Set K192046 is a FDA 510(k) cleared microbiology medical device. Manufacturer: DiaSorin, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k192673/ 2019-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k192673-3m-comply-hydrogen-peroxide-indicator-fda-510k.jpg K192673 - 3M™ Comply™ Hydrogen Peroxide Indicator Tape 1228 K192673 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Oct 2019. https://www.510kdatabase.net/k192802/ 2019-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k192802-primemidline-catheters-fda-510k.jpg K192802 - primeMidline Catheters K192802 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Pfm Medical, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k190624/ 2019-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k190624-earlyvue-vs30-fda-510k.jpg K190624 - EarlyVue VS30 K190624 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Philips Medizin Systeme Boeblingen GmbH. Cleared Oct 2019. https://www.510kdatabase.net/k190181/ 2019-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k190181-instruments-for-link-megasystem-c-family-fda-510k.jpg K190181 - Instruments for LINK MEGASYSTEM-C Family K190181 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: LinkBio Corp.. Cleared Oct 2019. https://www.510kdatabase.net/k190221/ 2019-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k190221-iob-warming-blankets-fda-510k.jpg K190221 - IOB Warming Blankets K190221 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Iob Medical, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k190847/ 2019-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k190847-redapt-blade-augments-fda-510k.jpg K190847 - REDAPT Blade Augments K190847 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k191007/ 2019-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k191007-aixplorer-mach-30-aixplorer-mach-20-fda-510k.jpg K191007 - Aixplorer MACH 30, Aixplorer MACH 20 Ultrasound Diagnostic Systems K191007 is a FDA 510(k) cleared radiology medical device. Manufacturer: Supersonic Imagine. Cleared Oct 2019. https://www.510kdatabase.net/k191085/ 2019-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k191085-maverick-rnp-assay-and-maverick-fda-510k.jpg K191085 - Maverick RNP Assay and Maverick Diagnostic System K191085 is a FDA 510(k) cleared immunology medical device. Manufacturer: Genalyte, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k191470/ 2019-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k191470-c-cat-anaesthesia-catheter-kit-fda-510k.jpg K191470 - C-CAT Anaesthesia Catheter kit K191470 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Cimpax Aps. Cleared Oct 2019. https://www.510kdatabase.net/k191563/ 2019-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k191563-filtray-2g-disposable-water-filters-fda-510k.jpg K191563 - FILTRAY 2G Disposable Water Filters K191563 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Aqua-Tools. Cleared Oct 2019. https://www.510kdatabase.net/k191807/ 2019-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k191807-alpco-calprotectin-chemiluminescence-fda-510k.jpg K191807 - ALPCO Calprotectin Chemiluminescence ELISA, ALPCO Easy Stool Extraction Device K191807 is a FDA 510(k) cleared immunology medical device. Manufacturer: ALPCO. Cleared Oct 2019. https://www.510kdatabase.net/k191874/ 2019-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k191874-f5-corpus-vs-fda-510k.jpg K191874 - F5 Corpus VS K191874 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Permobil AB. Cleared Oct 2019. https://www.510kdatabase.net/k192360/ 2019-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k192360-intellamap-orion-high-resolution-fda-510k.jpg K192360 - IntellaMap Orion High Resolution Mapping Catheter K192360 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Oct 2019. https://www.510kdatabase.net/k192518/ 2019-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k192518-reusable-monopolar-active-cord-fda-510k.jpg K192518 - Reusable Monopolar Active Cord K192518 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Us Endoscopy. Cleared Oct 2019. https://www.510kdatabase.net/k192667/ 2019-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k192667-gel-e-flex-gel-otc-fda-510k.jpg K192667 - gel-e Flex+ gel OTC K192667 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Gel-E, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k192705/ 2019-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k192705-minicap-extended-life-pd-transfer-sets-fda-510k.jpg K192705 - MiniCap Extended Life PD Transfer Sets K192705 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare. Cleared Oct 2019. https://www.510kdatabase.net/k192725/ 2019-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k192725-cytal-wound-matrix-3-layer-fda-510k.jpg K192725 - Cytal Wound Matrix 3-Layer K192725 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Acell, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k192787/ 2019-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k192787-dexcom-g6-glucose-program-continuous-fda-510k.jpg K192787 - Dexcom G6 Glucose Program Continuous Glucose Monitoring (GCM) System K192787 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dexcom, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k181660/ 2019-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k181660-acapella-choice-blue-vibratory-pep-fda-510k.jpg K181660 - Acapella Choice Blue Vibratory PEP Device K181660 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Smiths Medical. Cleared Oct 2019. https://www.510kdatabase.net/k190037/ 2019-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k190037-cronus-hp-pta-balloon-catheter-fda-510k.jpg K190037 - Cronus HP PTA Balloon Catheter K190037 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nipro Medical Corporation. Cleared Oct 2019. https://www.510kdatabase.net/k190210/ 2019-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k190210-tear-pool-dissolvable-punctum-plugs-fda-510k.jpg K190210 - Tear Pool Dissolvable Punctum Plugs K190210 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Alphamed, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k190349/ 2019-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k190349-mediexpand-tl-expandable-vbr-system-fda-510k.jpg K190349 - MediExpand TL Expandable VBR System K190349 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Cmf Medicon Surgical, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k190426/ 2019-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k190426-alta-anterior-cervical-corpectomy-system-fda-510k.jpg K190426 - ALTA Anterior Cervical Corpectomy System K190426 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Astura Medical, LLC. Cleared Oct 2019. https://www.510kdatabase.net/k190556/ 2019-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k190556-zimmer-biomet-universal-navigation-fda-510k.jpg K190556 - Zimmer Biomet Universal Navigation System K190556 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer Biomet Spine, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k190632/ 2019-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k190632-latex-surgeons-gloves-powder-free-with-fda-510k.jpg K190632 - Latex Surgeon’s Gloves Powder Free with protein content labeling claim of 50µg/dm2 or less per glove of extractable protein K190632 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Lenora Glove Pvt , Ltd.. Cleared Oct 2019. https://www.510kdatabase.net/k191358/ 2019-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k191358-trident-ii-acetabular-system-fda-510k.jpg K191358 - Trident II Acetabular System K191358 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. Cleared Oct 2019. https://www.510kdatabase.net/k191812/ 2019-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k191812-adi-cervical-interbody-fusion-device-fda-510k.jpg K191812 - ADI Cervical Interbody Fusion Device K191812 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Additive Device, Inc. (Adi) D/B/A Restor3D. Cleared Oct 2019. https://www.510kdatabase.net/k191944/ 2019-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k191944-mu2net-fda-510k.jpg K191944 - MU2net K191944 is a FDA 510(k) cleared radiology medical device. Manufacturer: Dosisoft. Cleared Oct 2019. https://www.510kdatabase.net/k192678/ 2019-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k192678-genesys-spine-binary-lumbar-plate-system-fda-510k.jpg K192678 - Genesys Spine Binary® Lumbar Plate System K192678 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Genesys Spine. Cleared Oct 2019. https://www.510kdatabase.net/k192686/ 2019-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k192686-revolution-maxima-revolution-ace-fda-510k.jpg K192686 - Revolution Maxima, Revolution Ace K192686 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Hangwei Medical Systems Co., Ltd.. Cleared Oct 2019. https://www.510kdatabase.net/k192690/ 2019-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k192690-upgrade-kit-mr-gui-pro-mrj-3300-plus-fda-510k.jpg K192690 - Upgrade Kit MR GUI PRO, MrJ 3300 Plus K192690 is a FDA 510(k) cleared radiology medical device. Manufacturer: Asg Superconductors S.P.A.. Cleared Oct 2019. https://www.510kdatabase.net/k192722/ 2019-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k192722-padlock-clip-defect-closure-system-fda-510k.jpg K192722 - Padlock Clip defect closure system, Padlock Pro-Select defect closure device K192722 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: STERIS Corporation. Cleared Oct 2019. https://www.510kdatabase.net/k192728/ 2019-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k192728-agnes-fda-510k.jpg K192728 - Agnes K192728 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Agnes Medical Co., Ltd.. Cleared Oct 2019. https://www.510kdatabase.net/k182743/ 2019-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k182743-patient-specific-airway-stent-fda-510k.jpg K182743 - Patient-Specific Airway Stent K182743 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: New Cos, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k183562/ 2019-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k183562-powder-free-nitrile-examination-glove-fda-510k.jpg K183562 - Powder-Free Nitrile Examination Glove (White Colored, Blue Colored, and Black Colored) Tested for Use with Chemotherapy Drugs K183562 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Encompass Industries Sdn. Bhd.. Cleared Oct 2019. https://www.510kdatabase.net/k190157/ 2019-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k190157-diana-chemoclave-transfer-set-fda-510k.jpg K190157 - Diana ChemoClave Transfer Set K190157 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Icu Medical. Cleared Oct 2019. https://www.510kdatabase.net/k191258/ 2019-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k191258-intraosseous-infusion-device-fda-510k.jpg K191258 - Intraosseous infusion device K191258 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Einstein Works, LLC. Cleared Oct 2019. https://www.510kdatabase.net/k191814/ 2019-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k191814-alliance-glenoid-fda-510k.jpg K191814 - Alliance Glenoid K191814 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k192314/ 2019-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k192314-resonate-anterior-cervical-plate-system-fda-510k.jpg K192314 - RESONATE Anterior Cervical Plate System K192314 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k183309/ 2019-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k183309-stentfix-otsc-system-set-fda-510k.jpg K183309 - stentfix OTSC System Set K183309 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ovesco Endoscopy AG. Cleared Oct 2019. https://www.510kdatabase.net/k183661/ 2019-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k183661-clearedge-balance-system-fda-510k.jpg K183661 - ClearEdge Balance System K183661 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Quadrant Biosciences. Cleared Oct 2019. https://www.510kdatabase.net/k190539/ 2019-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k190539-turnsignal-stopcocks-sterile-fda-510k.jpg K190539 - TurnSignal Stopcocks Sterile, TurnSignal Stopcocks Buld Non Sterile, TurnSignal Stopcocks with Manifolds Sterile, TurnSignal Stopcocks with Manifolds Bulk Non Sterile K190539 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Monumedical, LLC. Cleared Oct 2019. https://www.510kdatabase.net/k190890/ 2019-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k190890-exactech-alteon-modular-dual-mobility-fda-510k.jpg K190890 - Exactech Alteon Modular Dual Mobility (MDM) System K190890 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k191073/ 2019-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k191073-vein360-endovenous-radiofrequency-fda-510k.jpg K191073 - Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter K191073 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Vein 360, LLC. Cleared Oct 2019. https://www.510kdatabase.net/k191373/ 2019-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k191373-vicryl-mesh-fda-510k.jpg K191373 - VICRYL Mesh K191373 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k191584/ 2019-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k191584-fortico-anterior-cervical-fixation-fda-510k.jpg K191584 - FORTICO Anterior Cervical Fixation System K191584 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Camber Spine Technologies, LLC. Cleared Oct 2019. https://www.510kdatabase.net/k191973/ 2019-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k191973-lumpipulse-g-ca19-9-n-fda-510k.jpg K191973 - Lumpipulse G CA19-9-N K191973 is a FDA 510(k) cleared immunology medical device. Manufacturer: Fujirebio Dianostics, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k191979/ 2019-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k191979-doro-qr3-xtom-headholder-system-fda-510k.jpg K191979 - DORO QR3 XTom Headholder System K191979 is a FDA 510(k) cleared neurology medical device. Manufacturer: Pro-Med Instruments GmbH. Cleared Oct 2019. https://www.510kdatabase.net/k192001/ 2019-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k192001-sterilucent-self-contained-biological-fda-510k.jpg K192001 - Sterilucent self-Contained Biological Indicator, Sterilucent Lumen Cycle Process Challenge Device, Sterilucent Flexible Cycle Process Challenge Device K192001 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sterilucent, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k192084/ 2019-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k192084-madison-total-knee-system-fda-510k.jpg K192084 - Madison Total Knee System K192084 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Implanet, S.A.. Cleared Oct 2019. https://www.510kdatabase.net/k192268/ 2019-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k192268-europa-pedicle-screw-system-fda-510k.jpg K192268 - Europa Pedicle Screw System K192268 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: MiRus, LLC. Cleared Oct 2019. https://www.510kdatabase.net/k192623/ 2019-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k192623-lipiflow-thermal-pulsation-system-fda-510k.jpg K192623 - LipiFlow Thermal Pulsation System K192623 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Tearscience, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k192737/ 2019-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k192737-rct800-fda-510k.jpg K192737 - RCT800 K192737 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ray Co., Ltd.. Cleared Oct 2019. https://www.510kdatabase.net/k192835/ 2019-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k192835-acuson-nx3-diagnostic-ultrasound-fda-510k.jpg K192835 - ACUSON NX3 Diagnostic Ultrasound System / ACUSON NX3 Elite Diagnostic Ultrasound System K192835 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k182862/ 2019-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k182862-servo-guard-fda-510k.jpg K182862 - Servo Guard K182862 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Maquet Critical Care AB. Cleared Oct 2019. https://www.510kdatabase.net/k190054/ 2019-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k190054-bd-insulin-syringe-fda-510k.jpg K190054 - BD Insulin Syringe K190054 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson and Company. Cleared Oct 2019. https://www.510kdatabase.net/k190136/ 2019-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k190136-fusion-silastic-system-fda-510k.jpg K190136 - Fusion Silastic System K190136 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Fusion Orthopedics, LLC. Cleared Oct 2019. https://www.510kdatabase.net/k190270/ 2019-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k190270-fore-sight-elite-tissue-oximeter-module-fda-510k.jpg K190270 - FORE-SIGHT ELITE Tissue Oximeter Module K190270 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cas Medical Systems, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k191957/ 2019-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k191957-bd-max-vaginal-panel-fda-510k.jpg K191957 - BD MAX Vaginal Panel K191957 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Geneohm Sciences Canada, Inc. (Bd Diagnostics). Cleared Oct 2019. https://www.510kdatabase.net/k191999/ 2019-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k191999-sterilucent-vh2o2-chemical-indicators-fda-510k.jpg K191999 - Sterilucent VH2O2 Chemical Indicators K191999 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sterilucent, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k192280/ 2019-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k192280-pentax-medical-ed-3490tk-video-fda-510k.jpg K192280 - PENTAX Medical ED-3490TK Video Duodenoscope K192280 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Pentax Medical. Cleared Oct 2019. https://www.510kdatabase.net/k192616/ 2019-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k192616-cangaroo-envelope-small-cangaroo-fda-510k.jpg K192616 - CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large), CanGaroo Envelope (extra extra large) (SubQ) K192616 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aziyo Biologics, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k192659/ 2019-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k192659-omnipod-insulin-management-system-fda-510k.jpg K192659 - Omnipod Insulin Management System, Omnipod DASH Insulin Management System K192659 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Insulet Corporation. Cleared Oct 2019. https://www.510kdatabase.net/k190124/ 2019-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k190124-ems-airflow-prophylaxis-master-ems-fda-510k.jpg K190124 - EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One K190124 is a FDA 510(k) cleared dental medical device. Manufacturer: E.M.S Electro Medical Systems S.A. Cleared Oct 2019. https://www.510kdatabase.net/k190636/ 2019-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k190636-nuvasive-reline-45-50-system-fda-510k.jpg K190636 - NuVasive® Reline® 4.5-5.0 System K190636 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Oct 2019. https://www.510kdatabase.net/k191513/ 2019-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k191513-altapore-shape-fda-510k.jpg K191513 - Altapore Shape K191513 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Baxter Healthcare Corporation. Cleared Oct 2019. https://www.510kdatabase.net/k192532/ 2019-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k192532-arthrex-swivelock-anchor-fda-510k.jpg K192532 - Arthrex SwiveLock Anchor K192532 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k181896/ 2019-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k181896-lipocel-fda-510k.jpg K181896 - LIPOcel K181896 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Jeisys Medical, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k183226/ 2019-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k183226-care-orchestrator-essence-fda-510k.jpg K183226 - Care Orchestrator Essence K183226 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k183274/ 2019-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k183274-rthawk-heartvista-cardiac-package-fda-510k.jpg K183274 - RTHawk, HeartVista Cardiac Package K183274 is a FDA 510(k) cleared radiology medical device. Manufacturer: Heartvista, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k183625/ 2019-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k183625-somnapatch-fda-510k.jpg K183625 - SomnaPatch K183625 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k190342/ 2019-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k190342-biafine-topical-cream-fda-510k.jpg K190342 - BIAFINE Topical Cream K190342 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bausch Health Americas Incorporated. Cleared Oct 2019. https://www.510kdatabase.net/k190465/ 2019-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k190465-evolve-breast-pump-fda-510k.jpg K190465 - Evolve Breast Pump K190465 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Hygeia II Medical Group, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k190646/ 2019-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k190646-qt-scanner-2000-model-a-fda-510k.jpg K190646 - QT Scanner 2000 Model A K190646 is a FDA 510(k) cleared radiology medical device. Manufacturer: Qt Ultrasound, LLC. Cleared Oct 2019. https://www.510kdatabase.net/k190795/ 2019-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k190795-tetragraph-neuromuscular-transmission-fda-510k.jpg K190795 - Tetragraph Neuromuscular Transmission Monitor K190795 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Senzime AB. Cleared Oct 2019. https://www.510kdatabase.net/k191283/ 2019-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k191283-infrared-thermometer-breeze-model-fda-510k.jpg K191283 - Infrared Thermometer, Breeze model K191283 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Suzhou Melodicare Medical Technology Co., Ltd.. Cleared Oct 2019. https://www.510kdatabase.net/k191430/ 2019-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k191430-pulse-oximeter-fda-510k.jpg K191430 - Pulse Oximeter K191430 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Yimi Life-Technology Co., Ltd.. Cleared Oct 2019. https://www.510kdatabase.net/k191436/ 2019-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k191436-saalio-fda-510k.jpg K191436 - Saalio K191436 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Saalmann Medical GmbH & Co. KG. Cleared Oct 2019. https://www.510kdatabase.net/k191544/ 2019-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k191544-synapse-3d-blood-flow-analysis-fda-510k.jpg K191544 - Synapse 3D Blood Flow Analysis K191544 is a FDA 510(k) cleared radiology medical device. Manufacturer: Fujifilm Corporation. Cleared Oct 2019. https://www.510kdatabase.net/k191668/ 2019-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k191668-infrared-forehead-thermometer-model-ir-fda-510k.jpg K191668 - Infrared Forehead Thermometer (Model IR-FT) K191668 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Comper Chuangxiang (Beijing) Technology Co., Ltd.. Cleared Oct 2019. https://www.510kdatabase.net/k191723/ 2019-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k191723-atec-iom-accessory-instruments-fda-510k.jpg K191723 - ATEC IOM Accessory Instruments K191723 is a FDA 510(k) cleared neurology medical device. Manufacturer: Alphatec Spine, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k191943/ 2019-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k191943-symphony-navigation-ready-instruments-fda-510k.jpg K191943 - SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor Set K191943 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International SARL. Cleared Oct 2019. https://www.510kdatabase.net/k192325/ 2019-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k192325-quantum-blood-and-fluid-warming-system-fda-510k.jpg K192325 - Quantum Blood and Fluid Warming System K192325 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Life Warmer, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k192593/ 2019-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k192593-confirm-rx-insertable-cardiac-monitor-fda-510k.jpg K192593 - Confirm Rx Insertable Cardiac Monitor K192593 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott. Cleared Oct 2019. https://www.510kdatabase.net/k192598/ 2019-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k192598-bashir-s-b-endovascular-catheter-ref-fda-510k.jpg K192598 - Bashir S-B Endovascular Catheter, Ref. No. 7101 K192598 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Thrombolex, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k192760/ 2019-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k192760-nuvasive-modulus-xlif-interbody-system-fda-510k.jpg K192760 - NuVasive Modulus XLIF Interbody System K192760 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Oct 2019. https://www.510kdatabase.net/k182073/ 2019-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k182073-bcss-picni-2000-sensor-fda-510k.jpg K182073 - BcSs-PICNI-2000 Sensor K182073 is a FDA 510(k) cleared neurology medical device. Manufacturer: Braincare Desenvolvimento E Inovacao Tecnologica S.A.. Cleared Oct 2019. https://www.510kdatabase.net/k183503/ 2019-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k183503-easymark-tissue-marker-fda-510k.jpg K183503 - EasyMark Tissue Marker K183503 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Inrad, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k190102/ 2019-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k190102-dyevert-plus-contrast-reduction-system-fda-510k.jpg K190102 - DyeVert™ Plus Contrast Reduction System, DyeTect™ Contrast Monitoring System, DyeVert™ Plus EZ Contrast Reduction System K190102 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Osprey Medical, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k190162/ 2019-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k190162-smartceph-fda-510k.jpg K190162 - SmartCeph K190162 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ortho2, LLC. Cleared Oct 2019. https://www.510kdatabase.net/k191216/ 2019-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k191216-voxel-dosimetry-v10-fda-510k.jpg K191216 - Voxel Dosimetry™ v1.0 K191216 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hermes Medical Solutions AB. Cleared Oct 2019. https://www.510kdatabase.net/k191653/ 2019-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k191653-freestyle-flex-fda-510k.jpg K191653 - Freestyle Flex K191653 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Medela AG. Cleared Oct 2019. https://www.510kdatabase.net/k191942/ 2019-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k191942-mt-one-diamond-fda-510k.jpg K191942 - MT One Diamond K191942 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: M&T S.R.L.. Cleared Oct 2019. https://www.510kdatabase.net/k192175/ 2019-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k192175-on-call-express-ii-blood-glucose-fda-510k.jpg K192175 - On Call Express II Blood Glucose Monitoring System K192175 is a FDA 510(k) cleared chemistry medical device. Manufacturer: ACON Laboratories, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k192239/ 2019-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k192239-wavelinq-plus-endoavf-system-fda-510k.jpg K192239 - WavelinQ Plus EndoAVF System K192239 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k192316/ 2019-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k192316-matrix-ha-peek-cervical-implant-system-fda-510k.jpg K192316 - Matrix HA PEEK Cervical Implant System K192316 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Sapphire Medical Group. Cleared Oct 2019. https://www.510kdatabase.net/k192441/ 2019-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k192441-arthrex-swivelock-anchors-fda-510k.jpg K192441 - Arthrex SwiveLock Anchors K192441 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k192455/ 2019-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k192455-merge-pacs-fda-510k.jpg K192455 - Merge PACS K192455 is a FDA 510(k) cleared radiology medical device. Manufacturer: Merge Healthcare Incorporated. Cleared Oct 2019. https://www.510kdatabase.net/k192556/ 2019-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k192556-carnation-ambulatory-monitor-fda-510k.jpg K192556 - Carnation Ambulatory Monitor K192556 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bardy Diagnostics, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k192566/ 2019-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k192566-reach-and-cqence-circular-staplers-fda-510k.jpg K192566 - Reach and CQ'ENCE Circular Staplers K192566 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Reach Surgical, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k190486/ 2019-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k190486-pitkar-external-fixation-system-fda-510k.jpg K190486 - Pitkar External Fixation System K190486 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: S.H.Pitkar Orthotools Pvt. , Ltd.. Cleared Oct 2019. https://www.510kdatabase.net/k190953/ 2019-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k190953-arthrex-minimally-invasive-ankle-fda-510k.jpg K190953 - Arthrex Minimally Invasive Ankle Fusion Plate K190953 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k191493/ 2019-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k191493-ventripoint-medical-system-plus-vms-30-fda-510k.jpg K191493 - Ventripoint Medical System Plus (VMS+) 3.0 K191493 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ventripoint Diagnostics , Ltd.. Cleared Oct 2019. https://www.510kdatabase.net/k191771/ 2019-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k191771-secure-screw-fda-510k.jpg K191771 - SECURE Screw K191771 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: A.M. Surgical, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k192250/ 2019-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k192250-sensititre-18-24-hour-mic-or-fda-510k.jpg K192250 - Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Imipenem-Relebactam in the dilution range of 0.03/4-256/4 ug/mL K192250 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Thermo Fisher Scientific. Cleared Oct 2019. https://www.510kdatabase.net/k192512/ 2019-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k192512-focus-35c-detector-trimax-35c-detector-fda-510k.jpg K192512 - Focus 35C Detector, Trimax 35C Detector K192512 is a FDA 510(k) cleared radiology medical device. Manufacturer: Iray Technology Taicang , Ltd.. Cleared Oct 2019. https://www.510kdatabase.net/k192541/ 2019-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k192541-digix-fdx-fda-510k.jpg K192541 - DigiX FDX K192541 is a FDA 510(k) cleared radiology medical device. Manufacturer: Allengers Medical Systems Limited. Cleared Oct 2019. https://www.510kdatabase.net/k190149/ 2019-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k190149-vial-adapter-20-mm-fda-510k.jpg K190149 - Vial Adapter Ø20 mm K190149 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Avenir Performance Europeenne Medical (Apem). Cleared Oct 2019. https://www.510kdatabase.net/k190840/ 2019-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k190840-medtronic-transportation-sterilization-fda-510k.jpg K190840 - Medtronic Transportation / Sterilization Cassettes K190840 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k191251/ 2019-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k191251-infared-thermometer-fda-510k.jpg K191251 - Infared Thermometer K191251 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen Calibeur Industries Co., Ltd.. Cleared Oct 2019. https://www.510kdatabase.net/k191326/ 2019-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k191326-arthrex-mini-comprehensive-fixation-fda-510k.jpg K191326 - Arthrex Mini Comprehensive Fixation System – 1.4mm & 1.6mm Module K191326 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k191672/ 2019-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k191672-nuface-mini-device-fda-510k.jpg K191672 - NuFACE Mini Device K191672 is a FDA 510(k) cleared neurology medical device. Manufacturer: Carol Cole Company Dba Nuface. Cleared Oct 2019. https://www.510kdatabase.net/k192194/ 2019-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k192194-totalshield-ii-surgical-helmet-system-fda-510k.jpg K192194 - TotalShield II Surgical Helmet System K192194 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zimmer Surgical, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k192434/ 2019-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k192434-dualx-lumbar-intervertebral-body-fda-510k.jpg K192434 - DualX Lumbar Intervertebral Body Fusion Device K192434 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Amplify Surgical, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k190937/ 2019-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k190937-echelon-endopath-staple-line-fda-510k.jpg K190937 - Echelon Endopath Staple Line Reinforcement K190937 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon Endo-Surgery, LLC. Cleared Oct 2019. https://www.510kdatabase.net/k183589/ 2019-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k183589-pmt-facet-screw-fda-510k.jpg K183589 - PMT Facet Screw K183589 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Providence Medical Technology, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k183674/ 2019-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k183674-electronic-pulse-stimulator-fda-510k.jpg K183674 - Electronic Pulse Stimulator K183674 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Leading Perfection Technology Co., Ltd.. Cleared Oct 2019. https://www.510kdatabase.net/k183681/ 2019-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k183681-protego-antimicrobial-wound-dressing-fda-510k.jpg K183681 - Protego Antimicrobial Wound Dressing K183681 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Global Health Solutions (Dba Turn Therapeutics). Cleared Oct 2019. https://www.510kdatabase.net/k190084/ 2019-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k190084-mclean-ring-enteral-feeding-tube-set-fda-510k.jpg K190084 - McLean-Ring Enteral Feeding Tube Set K190084 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Oct 2019. https://www.510kdatabase.net/k190713/ 2019-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k190713-fp-vitera-mask-full-face-a-model-small-fda-510k.jpg K190713 - F&P Vitera Mask Full Face A Model (Small, Medium, Large), F&P Vitera Mask Full Face Sleep Lab Model (Small, Medium, Large) K190713 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Fisher &Paykel Healthcare , Ltd.. Cleared Oct 2019. https://www.510kdatabase.net/k191181/ 2019-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k191181-nxpro-neuromuscular-electrical-fda-510k.jpg K191181 - NXPRO Neuromuscular Electrical Stimulation Device K191181 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Neux Technologies, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k191208/ 2019-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k191208-spectra-cashmere-fda-510k.jpg K191208 - Spectra Cashmere K191208 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Uzinmedicare Co.. Cleared Oct 2019. https://www.510kdatabase.net/k191420/ 2019-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k191420-reusable-spo2-sensor-fda-510k.jpg K191420 - Reusable SpO2 Sensor K191420 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Changke Connect Electronics Co., Ltd.. Cleared Oct 2019. https://www.510kdatabase.net/k191480/ 2019-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k191480-wet-water-based-personal-lubricant-fda-510k.jpg K191480 - Wet Water Based Personal Lubricant (additionally, branded as WET Platinum Houston, Elite Water-Based Hybrid) K191480 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Trigg Laboratories, Inc. D/B/A Wet International. Cleared Oct 2019. https://www.510kdatabase.net/k191542/ 2019-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k191542-apyx-plasmarf-handpiece-fda-510k.jpg K191542 - Apyx Plasma/RF Handpiece K191542 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bovie Medical Corporation Dba Apyx Medical Corporation. Cleared Oct 2019. https://www.510kdatabase.net/k191548/ 2019-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k191548-nexus-universal-self-cure-fda-510k.jpg K191548 - Nexus Universal Self-Cure K191548 is a FDA 510(k) cleared dental medical device. Manufacturer: Kerr Corporation. Cleared Oct 2019. https://www.510kdatabase.net/k191684/ 2019-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k191684-monitorr-icp-external-drainage-and-fda-510k.jpg K191684 - MoniTorr ICP External Drainage and Monitoring System, LimiTorr Volume Limiting External CSF Drainage System K191684 is a FDA 510(k) cleared neurology medical device. Manufacturer: Integra LifeSciences Corporation. Cleared Oct 2019. https://www.510kdatabase.net/k191822/ 2019-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k191822-nano-forticore-forticore-fda-510k.jpg K191822 - Nano FortiCore, FortiCore K191822 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nanovis, LLC. Cleared Oct 2019. https://www.510kdatabase.net/k191902/ 2019-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k191902-razor-everest-uc-liquid-fda-510k.jpg K191902 - Razor, Everest, U&C Liquid K191902 is a FDA 510(k) cleared dental medical device. Manufacturer: U&C International Co., Ltd.. Cleared Oct 2019. https://www.510kdatabase.net/k192057/ 2019-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k192057-k-pack-ii-needle-27g-x-12-extra-thin-fda-510k.jpg K192057 - K-Pack II Needle - 27G x 1/2” Extra Thin Wall, K-Pack II Needle - 27G x 1/2” Ultra Thin Wall, K-Pack II Needle - 30G x 1/2” Extra Thin Wall, K-Pack II Needle - 30G x 1/2” Ultra Thin Wall K192057 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terumo Europe N.V.. Cleared Oct 2019. https://www.510kdatabase.net/k192214/ 2019-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k192214-carboclear-vbr-system-fda-510k.jpg K192214 - CarboClear VBR System K192214 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: CarboFix Orthopedics , Ltd.. Cleared Oct 2019. https://www.510kdatabase.net/k192235/ 2019-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k192235-aeon-laparoscopic-instruments-fda-510k.jpg K192235 - AEON Laparoscopic Instruments K192235 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lexington Medical, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k192312/ 2019-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k192312-zimmer-natural-nail-system-fda-510k.jpg K192312 - Zimmer Natural Nail System Cephalomedullary Nails K192312 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer GmbH. Cleared Oct 2019. https://www.510kdatabase.net/k192515/ 2019-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k192515-bioeasy-marijuana-test-dip-card-40-fda-510k.jpg K192515 - BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY Marijuana Test Strip 40, BIOEASY Marijuana Test Strip 20 K192515 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Shenzhen Bioeasy Biotechnology Co., Ltd.. Cleared Oct 2019. https://www.510kdatabase.net/k182136/ 2019-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k182136-intelligent-wireless-fitness-apparatus-fda-510k.jpg K182136 - Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303) K182136 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Osto Technology Co., Ltd.. Cleared Oct 2019. https://www.510kdatabase.net/k182184/ 2019-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k182184-paper-sterilization-pouch-and-fda-510k.jpg K182184 - Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted) K182184 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Mdk (Shanghai) Medical Packing Co., Ltd.. Cleared Oct 2019. https://www.510kdatabase.net/k190319/ 2019-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k190319-waterlase-laser-system-family-fda-510k.jpg K190319 - Waterlase Laser System Family K190319 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Biolase, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k190386/ 2019-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k190386-kta-adipose-treatment-kit-fda-510k.jpg K190386 - KTA Adipose Treatment Kit K190386 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stemics S.A.S. Cleared Oct 2019. https://www.510kdatabase.net/k190523/ 2019-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k190523-cranial-psi-accessory-anatomical-model-fda-510k.jpg K190523 - Cranial PSI Accessory – Anatomical Model Original, Cranial PSI Accessory – Anatomical Model Modified, Cranial PSI Accessory – Plastic Drawing Guide, Cranial PSI Accessory – Cranial Implant Trial K190523 is a FDA 510(k) cleared neurology medical device. Manufacturer: Ossdsign AB. Cleared Oct 2019. https://www.510kdatabase.net/k190772/ 2019-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k190772-surgical-microscope-system-orbeye-with-fda-510k.jpg K190772 - SURGICAL MICROSCOPE SYSTEM ORBEYE with IR K190772 is a FDA 510(k) cleared neurology medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Oct 2019. https://www.510kdatabase.net/k191010/ 2019-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k191010-palladium-high-flow-therapy-system-fda-510k.jpg K191010 - Palladium High Flow Therapy System K191010 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Vapotherm, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k191174/ 2019-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k191174-mercy-babytape-fda-510k.jpg K191174 - Mercy babyTAPE K191174 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Children'S Mercy Hospital. Cleared Oct 2019. https://www.510kdatabase.net/k191417/ 2019-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k191417-belun-ring-fda-510k.jpg K191417 - Belun Ring K191417 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Belun Technology Company Limited. Cleared Oct 2019. https://www.510kdatabase.net/k191458/ 2019-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k191458-legacy-smartbase-abutments-fda-510k.jpg K191458 - Legacy SMARTBase Abutments K191458 is a FDA 510(k) cleared dental medical device. Manufacturer: Implant Direct Sybron Manufacturing, LLC. Cleared Oct 2019. https://www.510kdatabase.net/k191659/ 2019-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k191659-instylla-delivery-kit-fda-510k.jpg K191659 - Instylla Delivery Kit K191659 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Instylla, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k191963/ 2019-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k191963-smr-finned-short-stems-fda-510k.jpg K191963 - SMR Finned Short Stems K191963 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Lima Corporate S.P.A.. Cleared Oct 2019. https://www.510kdatabase.net/k192147/ 2019-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k192147-halyard-one-step-sterilization-wrap-fda-510k.jpg K192147 - Halyard ONE-STEP* Sterilization Wrap K192147 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Owens & Minor (O&M) Halyard, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k192210/ 2019-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k192210-esotest-multi-esophageal-temperature-fda-510k.jpg K192210 - ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System K192210 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Fiab Spa. Cleared Oct 2019. https://www.510kdatabase.net/k192465/ 2019-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k192465-digifix-sterile-kit-fda-510k.jpg K192465 - DigiFix Sterile Kit K192465 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Virak Orthopedics, LLC. Cleared Oct 2019. https://www.510kdatabase.net/k192474/ 2019-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k192474-vera-fda-510k.jpg K192474 - VERA K192474 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Reflexion Health, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k192526/ 2019-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k192526-spine-wave-navigated-instruments-fda-510k.jpg K192526 - Spine Wave Navigated Instruments K192526 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spine Wave, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/den190025/ 2019-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/den190025-oraquick-ebola-rapid-antigen-test-fda-510k.jpg DEN190025 - OraQuick Ebola Rapid Antigen Test DEN190025 is a FDA 510(k) cleared microbiology medical device. Manufacturer: OraSure Technologies, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k182448/ 2019-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k182448-anyridge-octa-1-implant-system-fda-510k.jpg K182448 - AnyRidge Octa 1 Implant System K182448 is a FDA 510(k) cleared dental medical device. Manufacturer: Megagen Implant Co., Ltd.. Cleared Oct 2019. https://www.510kdatabase.net/k190314/ 2019-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k190314-advanced-intelligent-volumetric-fda-510k.jpg K190314 - Advanced Intelligent Volumetric Ultrasound System, Model AiVUS 1000 K190314 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mednovel Technology, Ltd.. Cleared Oct 2019. https://www.510kdatabase.net/k190321/ 2019-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k190321-pediatric-nailing-platformfemur-fda-510k.jpg K190321 - Pediatric Nailing PlatformFemur K190321 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OrthoPediatrics Corp.. Cleared Oct 2019. https://www.510kdatabase.net/k190630/ 2019-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k190630-solidairity-iii-airway-stabilization-fda-510k.jpg K190630 - SolidAIRity III Airway Stabilization System K190630 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Securisyn Medical, LLC. Cleared Oct 2019. https://www.510kdatabase.net/k191359/ 2019-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k191359-nipro-syringe-fda-510k.jpg K191359 - Nipro Syringe K191359 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Nipro Medical Corporation. Cleared Oct 2019. https://www.510kdatabase.net/k191523/ 2019-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k191523-visalys-restorative-primer-fda-510k.jpg K191523 - Visalys Restorative Primer K191523 is a FDA 510(k) cleared dental medical device. Manufacturer: Kettenbach GmbH & Co. KG. Cleared Oct 2019. https://www.510kdatabase.net/k191596/ 2019-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k191596-arcadia-balloon-catheter-fda-510k.jpg K191596 - Arcadia Balloon Catheter K191596 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k191687/ 2019-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k191687-portal-steerable-hydrophilic-guidewire-fda-510k.jpg K191687 - pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire K191687 is a FDA 510(k) cleared neurology medical device. Manufacturer: Phenox Limited. Cleared Oct 2019. https://www.510kdatabase.net/k191783/ 2019-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k191783-parcus-synd-ez-ti-fda-510k.jpg K191783 - Parcus Synd-EZ Ti K191783 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Parcus Medical, LLC. Cleared Oct 2019. https://www.510kdatabase.net/k192185/ 2019-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k192185-the-cellfina-system-fda-510k.jpg K192185 - The Cellfina System K192185 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ulthera, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k192200/ 2019-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k192200-dynacad-fda-510k.jpg K192200 - DynaCAD K192200 is a FDA 510(k) cleared radiology medical device. Manufacturer: Invivo Corporation. Cleared Oct 2019. https://www.510kdatabase.net/k192208/ 2019-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k192208-cornice-cervical-spacer-system-fda-510k.jpg K192208 - CORNICE Cervical Spacer System K192208 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Legend Spine Technologies. Cleared Oct 2019. https://www.510kdatabase.net/k182773/ 2019-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k182773-single-use-non-stick-bipolar-forceps-fda-510k.jpg K182773 - Single-Use Non-Stick Bipolar forceps Bayonet, Single-Use Non-Stick Bipolar Irrigating forceps, Single Use Non-Stick Bipolar Suction forceps K182773 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Faulhaber Pinzetten Ohg. Cleared Oct 2019. https://www.510kdatabase.net/k183171/ 2019-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k183171-scopeseal-duodenoscope-protective-device-fda-510k.jpg K183171 - ScopeSeal Duodenoscope Protective Device K183171 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Gi Scientific, LLC. Cleared Oct 2019. https://www.510kdatabase.net/k191127/ 2019-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k191127-advanced-intermezzo-implant-system-fda-510k.jpg K191127 - Advanced Intermezzo Implant System K191127 is a FDA 510(k) cleared dental medical device. Manufacturer: Megagen Implant Co., Ltd.. Cleared Oct 2019. https://www.510kdatabase.net/k191133/ 2019-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k191133-katana-cleaner-katana-cleaner-trial-fda-510k.jpg K191133 - KATANA Cleaner, KATANA Cleaner (Trial) K191133 is a FDA 510(k) cleared dental medical device. Manufacturer: Kuraray Noritake Dental, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k191150/ 2019-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k191150-bodycad-unicompartmental-knee-system-fda-510k.jpg K191150 - Bodycad Unicompartmental Knee System K191150 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Bodycad Laboratories, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k191369/ 2019-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k191369-tsolution-one-total-knee-application-fda-510k.jpg K191369 - TSolution One Total Knee Application K191369 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: THINK Surgical, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k191448/ 2019-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k191448-barrier-sleeves-fda-510k.jpg K191448 - Barrier Sleeves K191448 is a FDA 510(k) cleared dental medical device. Manufacturer: Ivoclar Vivadent, AG. Cleared Oct 2019. https://www.510kdatabase.net/k191779/ 2019-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k191779-attune-revision-lps-inserts-fda-510k.jpg K191779 - Attune Revision LPS Inserts K191779 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy(Ireland). Cleared Oct 2019. https://www.510kdatabase.net/k191854/ 2019-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k191854-premia-spine-xl-instruments-fda-510k.jpg K191854 - Premia Spine XL Instruments K191854 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Premia Spine, Ltd.. Cleared Oct 2019. https://www.510kdatabase.net/k192206/ 2019-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k192206-32mm-glenosphere-and-humeral-cup-fda-510k.jpg K192206 - 32mm Glenosphere and Humeral Cup K192206 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Fx Shoulder USA, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k190086/ 2019-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k190086-cepheid-xpert-respiratory-control-panel-fda-510k.jpg K190086 - Cepheid Xpert Respiratory Control Panel K190086 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Microbiologics, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k190538/ 2019-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k190538-nio-i-fda-510k.jpg K190538 - NIO-I K190538 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Waismed, Ltd.. Cleared Oct 2019. https://www.510kdatabase.net/k191431/ 2019-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k191431-interlude-rolled-tampons-in-plastic-fda-510k.jpg K191431 - Interlude Rolled Tampons in Plastic Applicator K191431 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Albaad Fem. Cleared Oct 2019. https://www.510kdatabase.net/k191632/ 2019-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k191632-profemur-tl2-stems-fda-510k.jpg K191632 - PROFEMUR TL2 Stems K191632 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Microport Orthopedics, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k191833/ 2019-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k191833-dexcom-g6-pro-continuous-glucose-fda-510k.jpg K191833 - Dexcom G6 Pro Continuous Glucose Monitoring System K191833 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dexcom, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k192428/ 2019-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k192428-afx-femoral-implant-with-inserter-fda-510k.jpg K192428 - AFX Femoral Implant with Inserter K192428 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Cayenne Medical. Cleared Oct 2019. https://www.510kdatabase.net/k183441/ 2019-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k183441-powder-free-nitrile-patient-fda-510k.jpg K183441 - Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs K183441 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Semperit Investments Asia Pte , Ltd.. Cleared Oct 2019. https://www.510kdatabase.net/k183710/ 2019-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k183710-vivio-system-fda-510k.jpg K183710 - Vivio System K183710 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Avicena, LLC. Cleared Oct 2019. https://www.510kdatabase.net/k190060/ 2019-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k190060-urethrotech-ucd-fda-510k.jpg K190060 - Urethrotech UCD K190060 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Urethrotech. Cleared Oct 2019. https://www.510kdatabase.net/k190183/ 2019-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k190183-hypodermic-safety-needle-hypodermic-fda-510k.jpg K190183 - Hypodermic Safety Needle, Hypodermic Safety Needle with Syringe K190183 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.. Cleared Oct 2019. https://www.510kdatabase.net/k190298/ 2019-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k190298-dxa-5000-dxi-800-access-immunoassay-fda-510k.jpg K190298 - DxA 5000, DxI 800 Access Immunoassay System, Access Ferritin, Access Folate, Access TSH (3rd IS), Access Vitamin B12 K190298 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter Biomedical GmbH. Cleared Oct 2019. https://www.510kdatabase.net/k190591/ 2019-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k190591-safergel-sterile-ultrasound-gel-fda-510k.jpg K190591 - Safergel Sterile Ultrasound Gel K190591 is a FDA 510(k) cleared radiology medical device. Manufacturer: Safersonic Us, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k190940/ 2019-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k190940-tokuyama-rebase-iii-fda-510k.jpg K190940 - Tokuyama Rebase III K190940 is a FDA 510(k) cleared dental medical device. Manufacturer: Tokuyama Dental Corporation. Cleared Oct 2019. https://www.510kdatabase.net/k191713/ 2019-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k191713-cs-series-fp-radiographic-fluoroscopic-fda-510k.jpg K191713 - CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S / FluoroShield™ (ROI Assembly) K191713 is a FDA 510(k) cleared radiology medical device. Manufacturer: Omega Medical Imaging, LLC. Cleared Oct 2019. https://www.510kdatabase.net/k191843/ 2019-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k191843-ceramill-a-temp-fda-510k.jpg K191843 - Ceramill A-Temp K191843 is a FDA 510(k) cleared dental medical device. Manufacturer: Amann Girrbach AG. Cleared Oct 2019. https://www.510kdatabase.net/k191994/ 2019-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k191994-profound-ai-software-v21-fda-510k.jpg K191994 - ProFound AI Software V2.1 K191994 is a FDA 510(k) cleared radiology medical device. Manufacturer: Icad, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k192005/ 2019-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k192005-bausch-lomb-prevue-inserter-for-fda-510k.jpg K192005 - Bausch + Lomb PreVue Inserter for enVista Preloaded K192005 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Bausch & Lomb, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k192128/ 2019-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k192128-sutter-arrowtip-monopolar-electrodes-fda-510k.jpg K192128 - Sutter Arrowtip Monopolar Electrodes K192128 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sutter Medizintechnik GmbH. Cleared Oct 2019. https://www.510kdatabase.net/k192422/ 2019-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k192422-steerable-introducer-12f-fda-510k.jpg K192422 - Steerable Introducer 12F K192422 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Freudenberg Medical, LLC. Cleared Oct 2019. https://www.510kdatabase.net/k192433/ 2019-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k192433-lzi-methadone-ii-enzyme-immunoassay-fda-510k.jpg K192433 - LZI Methadone II Enzyme Immunoassay K192433 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Lin-Zhi International, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k192448/ 2019-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k192448-delta-xtend-revers-shoulder-system-fda-510k.jpg K192448 - Delta Xtend Revers Shoulder System K192448 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy(Ireland). Cleared Oct 2019. https://www.510kdatabase.net/k182143/ 2019-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k182143-alfa-gate-dental-implants-system-fda-510k.jpg K182143 - ALFA GATE Dental Implants System K182143 is a FDA 510(k) cleared dental medical device. Manufacturer: Alfa Gate Mazen, Ltd.. Cleared Oct 2019. https://www.510kdatabase.net/k183479/ 2019-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k183479-asthma-monitor-am3-fda-510k.jpg K183479 - Asthma Monitor AM3 K183479 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Eresearch Technology. Cleared Oct 2019. https://www.510kdatabase.net/k190179/ 2019-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k190179-sahara-stabilization-system-fda-510k.jpg K190179 - SAHARA Stabilization System K190179 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: K2m, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k190208/ 2019-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k190208-diversatek-healthcare-high-resolution-fda-510k.jpg K190208 - Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe K190208 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Diversatek Healthcare. Cleared Oct 2019. https://www.510kdatabase.net/k191066/ 2019-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k191066-cd-horizon-astute-spinal-system-fda-510k.jpg K191066 - CD Horizon™ Astute™ Spinal System K191066 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k191099/ 2019-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k191099-atlas-multi-drugs-screening-test-cup-fda-510k.jpg K191099 - Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel K191099 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Atlas Medical. Cleared Oct 2019. https://www.510kdatabase.net/k191332/ 2019-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k191332-xact-robotic-system-fda-510k.jpg K191332 - XACT Robotic System K191332 is a FDA 510(k) cleared radiology medical device. Manufacturer: Xact Robotics, Ltd.. Cleared Oct 2019. https://www.510kdatabase.net/k191344/ 2019-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k191344-arthrex-mini-comprehensive-fixation-fda-510k.jpg K191344 - Arthrex Mini Comprehensive Fixation System – 2.0mm & 2.4mm Module K191344 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k191490/ 2019-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k191490-retractable-safety-syringe-retractable-fda-510k.jpg K191490 - Retractable Safety Syringe, Retractable Safety Insulin Syringe, Retractable Safety Tuberculin Syringe, Retractable Safety Allergy Syringe K191490 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Caina Medical Co.,Ltd. Cleared Oct 2019. https://www.510kdatabase.net/k191794/ 2019-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k191794-vintage-art-universal-fda-510k.jpg K191794 - Vintage Art Universal K191794 is a FDA 510(k) cleared dental medical device. Manufacturer: Shofu Dental Corporation. Cleared Oct 2019. https://www.510kdatabase.net/k191806/ 2019-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k191806-propex-iq-apex-locator-fda-510k.jpg K191806 - Propex IQ Apex Locator K191806 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona. Cleared Oct 2019. https://www.510kdatabase.net/k191993/ 2019-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k191993-yumizen-c1200-crp-fda-510k.jpg K191993 - Yumizen C1200 CRP K191993 is a FDA 510(k) cleared chemistry medical device. Manufacturer: HORIBA ABX SAS. Cleared Oct 2019. https://www.510kdatabase.net/k192318/ 2019-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k192318-ultraverse-014-and-018-pta-balloon-fda-510k.jpg K192318 - Ultraverse 014 and 018 PTA Balloon Dilatation Catheters K192318 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bard Peripheral Vascular, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k192398/ 2019-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k192398-millenium-hx-fda-510k.jpg K192398 - Millenium HX K192398 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Mar Cor Purification, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k192400/ 2019-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k192400-evs-4343a-evs-4343ag-evs-3643a-evs-fda-510k.jpg K192400 - EVS 4343A, EVS 4343AG, EVS 3643A, EVS 3643AG K192400 is a FDA 510(k) cleared radiology medical device. Manufacturer: DRTECH Corporation. Cleared Oct 2019. https://www.510kdatabase.net/k192424/ 2019-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k192424-mobius3d-fda-510k.jpg K192424 - Mobius3D K192424 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k192427/ 2019-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k192427-ablation-confirmation-fda-510k.jpg K192427 - Ablation Confirmation K192427 is a FDA 510(k) cleared radiology medical device. Manufacturer: Neuwave Medical, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k190820/ 2019-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k190820-aimanfun-lumea-comfort-fda-510k.jpg K190820 - Aimanfun Lumea Comfort K190820 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Kam Yuen Plastic Products , Ltd.. Cleared Oct 2019. https://www.510kdatabase.net/k191363/ 2019-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k191363-neocis-planning-software-application-fda-510k.jpg K191363 - Neocis Planning Software Application (NPSA) for 3rd Party PCs K191363 is a FDA 510(k) cleared dental medical device. Manufacturer: Neocis, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k191397/ 2019-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k191397-oxysoft-olifilcon-c-silicone-hydrogel-fda-510k.jpg K191397 - OxySoft (olifilcon C) silicone hydrogel soft contact lens K191397 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Visco Vision, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k191889/ 2019-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k191889-ng-test-carba-5-fda-510k.jpg K191889 - NG-Test CARBA 5 K191889 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Ng Biotech. Cleared Oct 2019. https://www.510kdatabase.net/k191932/ 2019-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k191932-momentum-posterior-spinal-fixation-fda-510k.jpg K191932 - Momentum™ Posterior Spinal Fixation System K191932 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ulrich Medical USA. Cleared Oct 2019. https://www.510kdatabase.net/k192064/ 2019-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k192064-liaison-vitamin-b12-fda-510k.jpg K192064 - LIAISON Vitamin B12 K192064 is a FDA 510(k) cleared chemistry medical device. Manufacturer: DiaSorin, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k183462/ 2019-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k183462-applied-biosystems-bacillus-anthracis-fda-510k.jpg K183462 - Applied Biosystems Bacillus anthracis Detection Kit K183462 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Mriglobal. Cleared Oct 2019. https://www.510kdatabase.net/k191507/ 2019-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k191507-intellijoint-navigation-system-fda-510k.jpg K191507 - Intellijoint® Navigation System K191507 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Intellijoint Surgical, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k191526/ 2019-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k191526-cardioblate-cryoflex-surgical-ablation-fda-510k.jpg K191526 - Cardioblate CryoFlex Surgical Ablation System K191526 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k191610/ 2019-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k191610-rtapp-fda-510k.jpg K191610 - RTapp K191610 is a FDA 510(k) cleared radiology medical device. Manufacturer: Segana, LLC. Cleared Oct 2019. https://www.510kdatabase.net/k191958/ 2019-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k191958-aveta-system-fda-510k.jpg K191958 - Aveta System K191958 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Meditrina, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k192303/ 2019-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k192303-exactvu-high-resolution-micro-fda-510k.jpg K192303 - ExactVu High Resolution Micro-Ultrasound System K192303 is a FDA 510(k) cleared radiology medical device. Manufacturer: Exact Imaging, Inc.. Cleared Oct 2019. https://www.510kdatabase.net/k192416/ 2019-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k192416-biolox-delta-ceramic-femoral-heads-fda-510k.jpg K192416 - BIOLOX Delta Ceramic Femoral Heads, BIOLOX Option Ceramic Femoral Head System K192416 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer GmbH. Cleared Oct 2019. https://www.510kdatabase.net/k192426/ 2019-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k192426-signa-voyager-signa-voyager-quantum-fda-510k.jpg K192426 - Signa Voyager, Signa Voyager Quantum K192426 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare (Tianjin) Company Limited. Cleared Oct 2019. https://www.510kdatabase.net/k192453/ 2019-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k192453-diamond-5a6a8a-fda-510k.jpg K192453 - DIAMOND-5A/6A/8A K192453 is a FDA 510(k) cleared radiology medical device. Manufacturer: DRGEM Corporation. Cleared Oct 2019. https://www.510kdatabase.net/k190048/ 2019-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k190048-ufii-anatomic-abutment-fda-510k.jpg K190048 - UF(II) Anatomic abutment K190048 is a FDA 510(k) cleared dental medical device. Manufacturer: Dio Corporation. Cleared Sep 2019. https://www.510kdatabase.net/k191774/ 2019-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k191774-smilealign-orthodontic-aligner-system-fda-510k.jpg K191774 - SmileAlign Orthodontic Aligner System K191774 is a FDA 510(k) cleared dental medical device. Manufacturer: 3D Global Biotech, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k191844/ 2019-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k191844-fidmi-low-profile-enteral-feeding-device-fda-510k.jpg K191844 - Fidmi Low Profile Enteral Feeding Device K191844 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fidmi Medical, Ltd.. Cleared Sep 2019. https://www.510kdatabase.net/k191848/ 2019-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k191848-aptus-wrist-spanning-plates-25-fda-510k.jpg K191848 - APTUS Wrist Spanning Plates 2.5 K191848 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medartis AG. Cleared Sep 2019. https://www.510kdatabase.net/k192425/ 2019-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k192425-hair-boom-69-hair-boom-air-ulike-hair-fda-510k.jpg K192425 - Hair Boom 69, Hair Boom Air, Ulike Hair UpUp K192425 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wontech Co., Ltd.. Cleared Sep 2019. https://www.510kdatabase.net/k191524/ 2019-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k191524-visalys-tooth-primer-fda-510k.jpg K191524 - Visalys Tooth Primer K191524 is a FDA 510(k) cleared dental medical device. Manufacturer: Kettenbach GmbH & Co. KG. Cleared Sep 2019. https://www.510kdatabase.net/k180001/ 2019-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k180001-disposable-breathsensor-adult-fda-510k.jpg K180001 - Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor Infant K180001 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Embla Systems. Cleared Sep 2019. https://www.510kdatabase.net/k181606/ 2019-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k181606-precision-spine-navigation-fda-510k.jpg K181606 - Precision Spine Navigation Instrumentation K181606 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Precision Spine, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k182722/ 2019-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k182722-xlr8-abdominal-wound-dressing-kit-fda-510k.jpg K182722 - XLR8 Abdominal Wound Dressing Kit K182722 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Genadyne Biotechnologies. Cleared Sep 2019. https://www.510kdatabase.net/k190024/ 2019-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k190024-smart-c-fda-510k.jpg K190024 - Smart-C K190024 is a FDA 510(k) cleared radiology medical device. Manufacturer: Turner Imaging Systems, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k190059/ 2019-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k190059-cerec-guides-fda-510k.jpg K190059 - CEREC Guides K190059 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona. Cleared Sep 2019. https://www.510kdatabase.net/k190076/ 2019-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k190076-xpert-bcr-abl-ultra-genexpert-dx-fda-510k.jpg K190076 - Xpert BCR-ABL Ultra, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems K190076 is a FDA 510(k) cleared pathology medical device. Manufacturer: Cepheid. Cleared Sep 2019. https://www.510kdatabase.net/k191074/ 2019-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k191074-sorrento-bone-graft-substitute-fda-510k.jpg K191074 - Sorrento Bone Graft Substitute K191074 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Xenco Medical, LLC. Cleared Sep 2019. https://www.510kdatabase.net/k191444/ 2019-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k191444-affinity-nt-oxygenator-with-balance-fda-510k.jpg K191444 - Affinity NT Oxygenator with Balance Biosurface, Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir K191444 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k191521/ 2019-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k191521-radiance-330-proton-beam-therapy-system-fda-510k.jpg K191521 - Radiance 330 Proton Beam Therapy System K191521 is a FDA 510(k) cleared radiology medical device. Manufacturer: Protom International Holding Corporation. Cleared Sep 2019. https://www.510kdatabase.net/k191747/ 2019-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k191747-fujifilm-duodenoscope-model-ed-580xt-fda-510k.jpg K191747 - FUJIFILM Duodenoscope Model ED-580XT K191747 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fujifilm Corporation. Cleared Sep 2019. https://www.510kdatabase.net/k192050/ 2019-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k192050-etest-eravacycline-erv-0002-32-gml-fda-510k.jpg K192050 - ETEST Eravacycline (ERV) (0.002 – 32 µg/mL) K192050 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Biomerieux S.A.. Cleared Sep 2019. https://www.510kdatabase.net/k192112/ 2019-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k192112-flexband-plus-fda-510k.jpg K192112 - FlexBand Plus K192112 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: International Life Sciences. Cleared Sep 2019. https://www.510kdatabase.net/k192129/ 2019-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k192129-clearcolor-1-day-hioxifilcon-a-daily-fda-510k.jpg K192129 - ClearColor 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens, Aryan Color 1-day (hioxifilcon A) Daily Disposable Soft (hydrophilic) Contact Lens K192129 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Clearlab SG Pte, Ltd.. Cleared Sep 2019. https://www.510kdatabase.net/k192352/ 2019-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k192352-minimax-fda-510k.jpg K192352 - MiniMAX K192352 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Sep 2019. https://www.510kdatabase.net/k192368/ 2019-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k192368-catsmart-fda-510k.jpg K192368 - CATSmart K192368 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Fresenius Kabi AG. Cleared Sep 2019. https://www.510kdatabase.net/k192421/ 2019-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k192421-epifaith-syringe-fda-510k.jpg K192421 - EpiFaith Syringe K192421 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Flat Medical Co., Ltd.. Cleared Sep 2019. https://www.510kdatabase.net/k182009/ 2019-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k182009-dia-proseal-fda-510k.jpg K182009 - Dia-Proseal K182009 is a FDA 510(k) cleared dental medical device. Manufacturer: DiaDent Group International. Cleared Sep 2019. https://www.510kdatabase.net/k190029/ 2019-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k190029-disposable-bladeless-trocar-disposable-fda-510k.jpg K190029 - Disposable Bladeless Trocar, Disposable Optical Trocar, Disposable Blunt-Tip Trocar, Disposable Spiral Trocar, Disposable Bladed Trocar K190029 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Changzhou Xin Neng Yuan Medical Stapler Co.,Ltd. Cleared Sep 2019. https://www.510kdatabase.net/k190199/ 2019-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k190199-sepasperm-washing-solution-sepasperm-fda-510k.jpg K190199 - SepaSperm Washing Solution, SepaSperm Solution K190199 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Kitazato Corporation. Cleared Sep 2019. https://www.510kdatabase.net/k190454/ 2019-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k190454-nitrile-powder-free-examination-glove-fda-510k.jpg K190454 - Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue) - Extended Cuff K190454 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hartalega NGC Sdn. Bhd.. Cleared Sep 2019. https://www.510kdatabase.net/k190466/ 2019-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k190466-pf-nitrile-exam-glove-with-ph-coating-fda-510k.jpg K190466 - PF Nitrile Exam Glove with pH coating, Black-Gray & White-Black Colors, Tested for Use with chemotheraphy drugs and Fentanyl Citrate K190466 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shen Wei (Usa), Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k191336/ 2019-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k191336-precice-system-fda-510k.jpg K191336 - PRECICE System K191336 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nuvasive Specialized Orthopedics, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k191530/ 2019-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k191530-stonechecker-fda-510k.jpg K191530 - StoneChecker K191530 is a FDA 510(k) cleared radiology medical device. Manufacturer: Imaging Biometrics, LLC. Cleared Sep 2019. https://www.510kdatabase.net/k191537/ 2019-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k191537-ecarbon-ibds-fda-510k.jpg K191537 - eCarbon IBDs K191537 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Back 2 Basics Direct, LLC. Cleared Sep 2019. https://www.510kdatabase.net/k191545/ 2019-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k191545-exogenesis-hernia-mesh-fda-510k.jpg K191545 - Exogenesis Hernia Mesh K191545 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Exogenesis Corporation. Cleared Sep 2019. https://www.510kdatabase.net/k191748/ 2019-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k191748-genesys-spine-sacroiliac-joint-fusion-fda-510k.jpg K191748 - Genesys Spine Sacroiliac Joint Fusion System K191748 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Genesys Spine. Cleared Sep 2019. https://www.510kdatabase.net/k192195/ 2019-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k192195-sterile-dilator-fda-510k.jpg K192195 - Sterile Dilator K192195 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Galt Medical Corp.. Cleared Sep 2019. https://www.510kdatabase.net/k192364/ 2019-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k192364-gxr-series-diagnostic-x-ray-system-fda-510k.jpg K192364 - GXR-Series Diagnostic X-Ray System K192364 is a FDA 510(k) cleared radiology medical device. Manufacturer: DRGEM Corporation. Cleared Sep 2019. https://www.510kdatabase.net/k192371/ 2019-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k192371-biozorb-sp-marker-fda-510k.jpg K192371 - BioZorb SP Marker K192371 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Focal Therapeutics. Cleared Sep 2019. https://www.510kdatabase.net/k192391/ 2019-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k192391-spectralis-hraoct-and-variants-fda-510k.jpg K192391 - Spectralis HRA+OCT and Variants K192391 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Heidelberg Engineering GmbH. Cleared Sep 2019. https://www.510kdatabase.net/k192435/ 2019-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k192435-nuvasive-nuvaline-fda-510k.jpg K192435 - NuVasive NuvaLine K192435 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Sep 2019. https://www.510kdatabase.net/k183190/ 2019-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k183190-nustat-fda-510k.jpg K183190 - NuStat K183190 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Beeken Biomedical, LLC. Cleared Sep 2019. https://www.510kdatabase.net/k183675/ 2019-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k183675-3d-visualization-system-fda-510k.jpg K183675 - 3D Visualization System K183675 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Scivita Medical Technology Co., Ltd.. Cleared Sep 2019. https://www.510kdatabase.net/k183687/ 2019-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k183687-lifewindow-lw8-lite-fda-510k.jpg K183687 - LifeWindow LW8 Lite K183687 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Digicare Biomedical Technology, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k190022/ 2019-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k190022-safebreath-filter-mouthpiece-fda-510k.jpg K190022 - SafeBreath Filter Mouthpiece K190022 is a FDA 510(k) cleared general hospital medical device. Manufacturer: MD Diagnostics Limited. Cleared Sep 2019. https://www.510kdatabase.net/k190323/ 2019-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k190323-aloe-glide-lubricant-fda-510k.jpg K190323 - Aloe Glide Lubricant K190323 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Desert Harvest, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k190536/ 2019-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k190536-mediracer-ncs-fda-510k.jpg K190536 - Mediracer NCS K190536 is a FDA 510(k) cleared neurology medical device. Manufacturer: Mediracer OY. Cleared Sep 2019. https://www.510kdatabase.net/k190875/ 2019-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k190875-eva-anterior-machine-eva-combined-fda-510k.jpg K190875 - EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector) K190875 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: D.O.R.C. Dutch Ophthalmic Research Center (International). Cleared Sep 2019. https://www.510kdatabase.net/k191742/ 2019-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k191742-aries-mrsa-assay-fda-510k.jpg K191742 - ARIES MRSA Assay K191742 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Luminex Corporation. Cleared Sep 2019. https://www.510kdatabase.net/k191765/ 2019-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k191765-omni-tin-coated-apex-knee-system-fda-510k.jpg K191765 - OMNI TiN Coated Apex Knee™ System K191765 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Omni Life Science, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k191791/ 2019-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k191791-trans1-interbody-fusion-system-fda-510k.jpg K191791 - TranS1 Interbody Fusion System K191791 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Trans1. Cleared Sep 2019. https://www.510kdatabase.net/k192011/ 2019-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k192011-phoenix-fda-510k.jpg K192011 - PhoeniX K192011 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sedecal., Sa.. Cleared Sep 2019. https://www.510kdatabase.net/k192102/ 2019-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k192102-thermoplastic-masks-fda-510k.jpg K192102 - Thermoplastic Masks K192102 is a FDA 510(k) cleared radiology medical device. Manufacturer: Aktina Medical Corporation. Cleared Sep 2019. https://www.510kdatabase.net/k183391/ 2019-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k183391-novidia-universal-bond-fda-510k.jpg K183391 - Novidia Universal Bond K183391 is a FDA 510(k) cleared dental medical device. Manufacturer: Nobio , Ltd.. Cleared Sep 2019. https://www.510kdatabase.net/k190574/ 2019-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k190574-patient-assistant-model-pa97000-fda-510k.jpg K190574 - Patient Assistant Model PA97000 K190574 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k191006/ 2019-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k191006-easislush-fda-510k.jpg K191006 - EasiSlush K191006 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Bridge TO Life, Ltd.. Cleared Sep 2019. https://www.510kdatabase.net/k191212/ 2019-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k191212-crossover-cross-connectors-depuy-pulse-fda-510k.jpg K191212 - CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cross Connectors, EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, E-Z Link Cross Connectors, ISOLA Spine System, MONARCH Spine System, MOSS MIAMI Spine System, TiMX Low Back System, VIPER Fenestrated Screw System, VIPER PRIME System, VIPER PRIME Fenestrated Screws, VIPER SAI (Sacral-Alar-Iliac), VIPER System, VIPER 2 System, VSP Spine System K191212 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International SARL. Cleared Sep 2019. https://www.510kdatabase.net/k191718/ 2019-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k191718-buhlmann-fcal-turbo-and-calex-cap-fda-510k.jpg K191718 - Buhlmann fCAL turbo and CALEX Cap K191718 is a FDA 510(k) cleared immunology medical device. Manufacturer: Buhlmann Laboratories AG. Cleared Sep 2019. https://www.510kdatabase.net/k191998/ 2019-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k191998-mako-total-hip-application-mako-total-fda-510k.jpg K191998 - Mako Total Hip Application, Mako Total Knee Application K191998 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Mako Surgical Corp.. Cleared Sep 2019. https://www.510kdatabase.net/k192010/ 2019-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k192010-smoothskin-bare-fda-510k.jpg K192010 - SmoothSkin BARE+ K192010 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cyden Limited. Cleared Sep 2019. https://www.510kdatabase.net/k192354/ 2019-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k192354-innovasis-gibralt-spine-system-fda-510k.jpg K192354 - Innovasis Gibralt Spine System K192354 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Innovasis, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k190100/ 2019-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k190100-ustar-ii-system-fda-510k.jpg K190100 - USTAR II System K190100 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: United Orthopedic Corporation. Cleared Sep 2019. https://www.510kdatabase.net/k190483/ 2019-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k190483-spira-open-matrix-alif-and-llif-fda-510k.jpg K190483 - SPIRA Open Matrix ALIF and LLIF K190483 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Camber Spine Technologies. Cleared Sep 2019. https://www.510kdatabase.net/k192322/ 2019-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k192322-t-stat-20-microvascular-tissue-oximeter-fda-510k.jpg K192322 - T-Stat 2.0 Microvascular Tissue Oximeter K192322 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Spectros Corporation. Cleared Sep 2019. https://www.510kdatabase.net/k182671/ 2019-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k182671-medi-direct-tens-pen-fda-510k.jpg K182671 - Medi-Direct TENS Pen K182671 is a FDA 510(k) cleared neurology medical device. Manufacturer: Jkh USA, LLC. Cleared Sep 2019. https://www.510kdatabase.net/k180523/ 2019-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k180523-intai-surgery-navigation-system-fda-510k.jpg K180523 - INTAI Surgery Navigation System K180523 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Intai Technology Corporation. Cleared Sep 2019. https://www.510kdatabase.net/k181428/ 2019-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k181428-clyra-wound-irrigation-solution-fda-510k.jpg K181428 - Clyra Wound Irrigation Solution K181428 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Clyra Medical Technologies, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k190001/ 2019-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k190001-supercath-5-fda-510k.jpg K190001 - Supercath 5 K190001 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Togo Medikit Co., Ltd.. Cleared Sep 2019. https://www.510kdatabase.net/k190856/ 2019-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k190856-seefactorct3-fda-510k.jpg K190856 - SeeFactorCT3 K190856 is a FDA 510(k) cleared radiology medical device. Manufacturer: Epica International, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k191324/ 2019-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k191324-civaderm-fda-510k.jpg K191324 - CivaDerm K191324 is a FDA 510(k) cleared radiology medical device. Manufacturer: Civatech Oncology, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k191679/ 2019-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k191679-omnipod-dash-insulin-management-system-fda-510k.jpg K191679 - Omnipod DASH Insulin Management System with interoperable technology K191679 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Insulet Corporation. Cleared Sep 2019. https://www.510kdatabase.net/k191927/ 2019-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k191927-hinged-laminoplasty-system-fda-510k.jpg K191927 - Hinged Laminoplasty System K191927 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k192259/ 2019-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k192259-philips-intellisite-pathology-solution-fda-510k.jpg K192259 - Philips IntelliSite Pathology Solution K192259 is a FDA 510(k) cleared pathology medical device. Manufacturer: Philips Electronics Nederland B.V.. Cleared Sep 2019. https://www.510kdatabase.net/k192276/ 2019-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k192276-merge-cardio-fda-510k.jpg K192276 - Merge Cardio K192276 is a FDA 510(k) cleared radiology medical device. Manufacturer: Merge Healthcare Incorporated. Cleared Sep 2019. https://www.510kdatabase.net/k192296/ 2019-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k192296-medtronic-6f-taiga-guiding-catheter-fda-510k.jpg K192296 - Medtronic 6F Taiga Guiding Catheter K192296 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Sep 2019. https://www.510kdatabase.net/k192301/ 2019-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k192301-bioeasy-marijuana-test-dip-card-fda-510k.jpg K192301 - BIOEASY Marijuana Test Dip Card, BIOEASY Marijuana Test Strip K192301 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Shenzhen Bioeasy Biotechnology Co., Ltd.. Cleared Sep 2019. https://www.510kdatabase.net/k192332/ 2019-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k192332-clottriever-thrombectormy-system-fda-510k.jpg K192332 - ClotTriever Thrombectormy System, ClotTriever Catheter, ClotTriever Sheath K192332 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inari Medical. Cleared Sep 2019. https://www.510kdatabase.net/k192402/ 2019-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k192402-syngoct-extended-functionality-fda-510k.jpg K192402 - syngo.CT Extended Functionality K192402 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k182631/ 2019-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k182631-supascoota-motorized-vehicle-spartan-fda-510k.jpg K182631 - SupaScoota Motorized vehicle - Spartan (Sumo)/ Spartan SP (Sumo SP) K182631 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Eurogreen International, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k190526/ 2019-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k190526-high-v-bone-cement-carboclear-fda-510k.jpg K190526 - High V+ Bone Cement, CarboClear® Fenestrated Pedicle Screws K190526 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: CarboFix Orthopedics , Ltd.. Cleared Sep 2019. https://www.510kdatabase.net/k191112/ 2019-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k191112-gehc-dxa-bone-densitometers-with-fda-510k.jpg K191112 - GEHC DXA Bone Densitometers with enCORE version 18 K191112 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. Cleared Sep 2019. https://www.510kdatabase.net/k192030/ 2019-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k192030-rs80-evo-diagnostic-ultrasound-system-fda-510k.jpg K192030 - RS80 EVO Diagnostic Ultrasound System K192030 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Medison Co., Ltd.. Cleared Sep 2019. https://www.510kdatabase.net/k192252/ 2019-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k192252-properformance-recovery-system-fda-510k.jpg K192252 - ProPerformance Recovery System K192252 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Menlo Brands, LLC. Cleared Sep 2019. https://www.510kdatabase.net/k192326/ 2019-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k192326-hardydisk-ast-lefamulin-20g-lmu20-fda-510k.jpg K192326 - HardyDisk AST Lefamulin 20µg (LMU20) K192326 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Hardy Diagnostics. Cleared Sep 2019. https://www.510kdatabase.net/k192344/ 2019-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k192344-sapphire-nc-plus-coronary-dilatation-fda-510k.jpg K192344 - Sapphire NC Plus Coronary Dilatation Catheter K192344 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Orbusneich Medical Trading, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k182292/ 2019-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k182292-vortran-apm-plus-fda-510k.jpg K182292 - VORTRAN APM-Plus K182292 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Vortran Medical Technology 1, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k183103/ 2019-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k183103-ems-belt-model-mc0485-fda-510k.jpg K183103 - EMS Belt (Model MC0485) K183103 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Dongguan Yingfeng Metal & Plastic Products Co., Ltd.. Cleared Sep 2019. https://www.510kdatabase.net/k183436/ 2019-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k183436-oracure-fda-510k.jpg K183436 - OraCure K183436 is a FDA 510(k) cleared dental medical device. Manufacturer: Tbm Corporation. Cleared Sep 2019. https://www.510kdatabase.net/k190563/ 2019-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k190563-4cis-peek-plif-cage-4cis-pebble-beach-fda-510k.jpg K190563 - 4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Augusta PEEK ALIF Cage K190563 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Solco Biomedical Co., Ltd.. Cleared Sep 2019. https://www.510kdatabase.net/k190858/ 2019-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k190858-bucked-stride-silicone-lubricant-fda-510k.jpg K190858 - Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant K190858 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: United Consortium. Cleared Sep 2019. https://www.510kdatabase.net/k191113/ 2019-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k191113-geko-t-2-and-geko-t-3-neuromuscular-fda-510k.jpg K191113 - geko T-2 and geko T-3 Neuromuscular Stimulators K191113 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Firstkind Limited. Cleared Sep 2019. https://www.510kdatabase.net/k191187/ 2019-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k191187-dornier-minnow-ureteral-catheter-fda-510k.jpg K191187 - Dornier MINNOW Ureteral Catheter K191187 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Dornier Medtech America, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k191232/ 2019-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k191232-accucath-ace-intravascular-catheter-fda-510k.jpg K191232 - AccuCath Ace Intravascular Catheter K191232 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k191357/ 2019-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k191357-flexible-hd-cysto-urethroscope-system-fda-510k.jpg K191357 - Flexible HD Cysto-Urethroscope System K191357 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k191391/ 2019-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k191391-hedron-lumbar-spacers-fda-510k.jpg K191391 - HEDRON Lumbar Spacers K191391 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k191457/ 2019-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k191457-bonebridge-system-bone-conduction-fda-510k.jpg K191457 - BONEBRIDGE System, Bone Conduction Implant Kit (BCI 602 Implant Kit), BCI 602 Sizer Kit, BCI 602 Lifts (1mm) K191457 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Med-El Elektromedizinische Geraete GmbH. Cleared Sep 2019. https://www.510kdatabase.net/k191552/ 2019-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k191552-gm501-mineral-oil-fda-510k.jpg K191552 - GM501 Mineral Oil K191552 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Hamilton Thorne, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k191663/ 2019-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k191663-aplio-a550-aplio-a450-and-aplio-a-fda-510k.jpg K191663 - Aplio a550, Aplio a450 and Aplio a, Diagnostic Ultrasound System, V4.0 K191663 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Sep 2019. https://www.510kdatabase.net/k192065/ 2019-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k192065-syngovia-rt-image-suite-fda-510k.jpg K192065 - Syngo.Via RT Image Suite K192065 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k192254/ 2019-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k192254-innosight-diagnostic-ultrasound-system-fda-510k.jpg K192254 - InnoSight Diagnostic Ultrasound System K192254 is a FDA 510(k) cleared radiology medical device. Manufacturer: Qisda Corporation. Cleared Sep 2019. https://www.510kdatabase.net/k181416/ 2019-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k181416-sapphire-dorsal-comfort-fit-fda-510k.jpg K181416 - Sapphire Dorsal Comfort Fit K181416 is a FDA 510(k) cleared dental medical device. Manufacturer: Crane Dental Laboratory, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k183708/ 2019-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k183708-poly-clear-fda-510k.jpg K183708 - Poly Clear K183708 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medtek Skincare, LLC. Cleared Sep 2019. https://www.510kdatabase.net/k190049/ 2019-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k190049-simsize-fda-510k.jpg K190049 - Sim&Size K190049 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sim&Cure. Cleared Sep 2019. https://www.510kdatabase.net/k190308/ 2019-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k190308-medicom-safemask-sofskin-pediatric-fda-510k.jpg K190308 - Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Sofskin Pediatric Procedure Earloop Face Masks, Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1), Medicom SafeMask Premier Pediatric Procedure Earloop Face Masks (ASTM Level 1) K190308 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Amd Medicom, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k191243/ 2019-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k191243-hedron-cervical-spacers-fda-510k.jpg K191243 - HEDRON Cervical Spacers K191243 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k191253/ 2019-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k191253-reusable-nibp-cuff-fda-510k.jpg K191253 - Reusable NIBP Cuff K191253 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Changke Connect Electronics Co., Ltd.. Cleared Sep 2019. https://www.510kdatabase.net/k191297/ 2019-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k191297-insitu-bipolar-hip-system-fda-510k.jpg K191297 - iNSitu Bipolar Hip System K191297 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Theken Companies, LLC. Cleared Sep 2019. https://www.510kdatabase.net/k191842/ 2019-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k191842-discovery-pico-discovery-pico-plus-fda-510k.jpg K191842 - Discovery Pico, Discovery Pico Plus, Discovery Pico Derm K191842 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Quanta System Spa. Cleared Sep 2019. https://www.510kdatabase.net/k191929/ 2019-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k191929-unicon-hydrogel-hioxifilcon-a-soft-fda-510k.jpg K191929 - UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens K191929 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Unicon Optical Co., Ltd.. Cleared Sep 2019. https://www.510kdatabase.net/k191947/ 2019-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k191947-vasoview-hemopro-extension-cable-fda-510k.jpg K191947 - VASOVIEW HEMOPRO Extension Cable, VASOVIEW HEMOPRO 2 Extension Cable, Bipolar Extension Cable, Fixed Distance, Active Return Cord K191947 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Maquet Cardiovascular, LLC. Cleared Sep 2019. https://www.510kdatabase.net/k192037/ 2019-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k192037-advisor-vl-circular-mapping-catheter-fda-510k.jpg K192037 - Advisor VL Circular Mapping Catheter, Sensor Enabled K192037 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared Sep 2019. https://www.510kdatabase.net/k192059/ 2019-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k192059-bio-guard-airwater-suction-valves-fda-510k.jpg K192059 - Bio Guard Air/Water & Suction Valves K192059 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: United States Endoscopy Group, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k190507/ 2019-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k190507-full-automatic-nibp-blood-pressure-fda-510k.jpg K190507 - Full Automatic (NIBP) Blood Pressure Monitor K190507 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Health & Life Co., Ltd.. Cleared Sep 2019. https://www.510kdatabase.net/k190708/ 2019-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k190708-accelfix-lumbar-interbody-fusion-cage-fda-510k.jpg K190708 - AccelFix Lumbar Interbody Fusion Cage System K190708 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: L & K Biomed Co., Ltd.. Cleared Sep 2019. https://www.510kdatabase.net/k191576/ 2019-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k191576-mercury-spinal-system-overwatch-spinal-fda-510k.jpg K191576 - Mercury® Spinal System, Overwatch® Spinal System K191576 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinal Elements, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k191641/ 2019-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k191641-affinity-variable-angle-distal-radius-fda-510k.jpg K191641 - AFFINITY – Variable Angle Distal Radius System, AFFINITY – Variable Angle Distal Radius Plates, AFFINITY – Variable Angle Distal Radius Screws K191641 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Industrias Medicas Sampedro S.A.S. Cleared Sep 2019. https://www.510kdatabase.net/k191676/ 2019-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k191676-intraox-20-handheld-tissue-oximeter-fda-510k.jpg K191676 - Intra.Ox 2.0 Handheld Tissue Oximeter K191676 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Vioptix, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k191685/ 2019-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k191685-picoway-laser-system-fda-510k.jpg K191685 - PicoWay Laser System K191685 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Candela Corporation. Cleared Sep 2019. https://www.510kdatabase.net/k191688/ 2019-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k191688-subtlemr-fda-510k.jpg K191688 - SubtleMR K191688 is a FDA 510(k) cleared radiology medical device. Manufacturer: Subtle Medical, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k191800/ 2019-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k191800-sterile-powder-free-nitrile-fda-510k.jpg K191800 - Sterile Powder Free Nitrile Examination Glove, Blue Colored, with Non-Pyrogenic Labeling Claim, Sterile Powder Free Nitrile Examination Glove, White Colored, with Non-Pyrogenic Labeling Claim K191800 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Kossan International Sdn Bhd. Cleared Sep 2019. https://www.510kdatabase.net/k191378/ 2019-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k191378-09-sodium-chloride-injection-usp-pre-fda-510k.jpg K191378 - 0.9% Sodium Chloride Injection, USP, Pre-filled COP Syringe K191378 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k181478/ 2019-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k181478-roosin-xeroform-petrolatum-dressing-fda-510k.jpg K181478 - Roosin Xeroform Petrolatum Dressing K181478 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Roosin Medical Co., Ltd.. Cleared Sep 2019. https://www.510kdatabase.net/k182921/ 2019-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k182921-infinix-universal-composite-fda-510k.jpg K182921 - Infinix Universal Composite K182921 is a FDA 510(k) cleared dental medical device. Manufacturer: Nobio , Ltd.. Cleared Sep 2019. https://www.510kdatabase.net/k183364/ 2019-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k183364-bellavista-fda-510k.jpg K183364 - Bellavista K183364 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Imtmedical AG. Cleared Sep 2019. https://www.510kdatabase.net/k183586/ 2019-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k183586-capmedic-fda-510k.jpg K183586 - CapMedic K183586 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Cognita Labs, LLC. Cleared Sep 2019. https://www.510kdatabase.net/k183670/ 2019-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k183670-vexillum-zephyr-olifilcon-a-with-fda-510k.jpg K183670 - Vexillum Zephyr (olifilcon A) with Tangible Polymers Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens K183670 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Visco Vision, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k190005/ 2019-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k190005-sterilucent-hc-80tt-hydrogen-peroxide-fda-510k.jpg K190005 - Sterilucent HC 80TT Hydrogen Peroxide Sterilizer K190005 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sterilucent, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k190288/ 2019-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k190288-arthrex-tenodesis-button-fda-510k.jpg K190288 - Arthrex Tenodesis Button K190288 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k190473/ 2019-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k190473-acist-rxi-system-and-navvus-ii-catheter-fda-510k.jpg K190473 - ACIST RXi System and Navvus II Catheter K190473 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Acist Medical Systems, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k190830/ 2019-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k190830-tdm-screw-systems-fda-510k.jpg K190830 - TDM Screw Systems K190830 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tdm Co., Ltd.. Cleared Sep 2019. https://www.510kdatabase.net/k190841/ 2019-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k190841-scenaria-view-fda-510k.jpg K190841 - SCENARIA View K190841 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hitachi Healthcare Americas. Cleared Sep 2019. https://www.510kdatabase.net/k190869/ 2019-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k190869-pulse-oximeter-fda-510k.jpg K190869 - Pulse Oximeter K190869 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Aeon Technology Co., Ltd.. Cleared Sep 2019. https://www.510kdatabase.net/k190932/ 2019-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k190932-rfid-localization-system-fda-510k.jpg K190932 - RFID Localization System K190932 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Health Beacons, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k191021/ 2019-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k191021-terragene-bionova-terragene-bionova-fda-510k.jpg K191021 - Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene Chemdye K191021 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terragene S.A.. Cleared Sep 2019. https://www.510kdatabase.net/k191273/ 2019-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k191273-multi-link-x2-ecg-and-spo2-adapter-fda-510k.jpg K191273 - Multi-Link X2 ECG and SpO2 Adapter K191273 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vyaire Medical, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k191459/ 2019-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k191459-juggerstitch-meniscal-repair-device-fda-510k.jpg K191459 - JuggerStitch Meniscal Repair Device K191459 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k191595/ 2019-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k191595-architect-stat-high-sensitivity-fda-510k.jpg K191595 - ARCHITECT STAT High Sensitivity Troponin-I K191595 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories Diagnostics Division. Cleared Sep 2019. https://www.510kdatabase.net/k191599/ 2019-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k191599-nico-myriad-novus-fda-510k.jpg K191599 - NICO Myriad NOVUS K191599 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Nico Corporation. Cleared Sep 2019. https://www.510kdatabase.net/k191801/ 2019-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k191801-probeat-cr-fda-510k.jpg K191801 - PROBEAT-CR K191801 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hitachi , Ltd.. Cleared Sep 2019. https://www.510kdatabase.net/k191949/ 2019-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k191949-unfolder-vitan-inserter-fda-510k.jpg K191949 - UNFOLDER Vitan Inserter K191949 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Johnson & Johnson Surgical Vision, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k192217/ 2019-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k192217-ncb-plating-system-distal-femur-and-fda-510k.jpg K192217 - NCB Plating System Distal Femur and Proximal Tibia K192217 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer GmbH. Cleared Sep 2019. https://www.510kdatabase.net/k192304/ 2019-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k192304-sis-software-version-360-fda-510k.jpg K192304 - SIS Software Version 3.6.0 K192304 is a FDA 510(k) cleared radiology medical device. Manufacturer: Surgical Information Sciences, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k182257/ 2019-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k182257-upnride-fda-510k.jpg K182257 - UPnRIDE K182257 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Upnride Robotics , Ltd.. Cleared Sep 2019. https://www.510kdatabase.net/k183662/ 2019-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k183662-saline-wound-wash-stericleansetm-fda-510k.jpg K183662 - Saline Wound Wash, SteriCleanse(TM) K183662 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ascent Consumer Products, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k183695/ 2019-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k183695-orthoanalysis-software-fda-510k.jpg K183695 - OrthoAnalysis Software K183695 is a FDA 510(k) cleared dental medical device. Manufacturer: Inteware Co., Ltd.. Cleared Sep 2019. https://www.510kdatabase.net/k190002/ 2019-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k190002-sterile-hypodermic-syringe-for-single-fda-510k.jpg K190002 - Sterile Hypodermic Syringe for Single use, with/without needle, Sterile Insulin Syringe for Single use, with needle, Sterile Hypodermic needle for Single use K190002 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shanghai Kohope Medical Devices Co., Ltd.. Cleared Sep 2019. https://www.510kdatabase.net/k190398/ 2019-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k190398-republic-spine-restore-intervertebral-fda-510k.jpg K190398 - Republic Spine Restore Intervertebral Body Fusion System K190398 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Republic Spine, LLC. Cleared Sep 2019. https://www.510kdatabase.net/k190768/ 2019-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k190768-artis-icono-fda-510k.jpg K190768 - ARTIS icono K190768 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k190780/ 2019-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k190780-syngo-application-software-fda-510k.jpg K190780 - syngo Application Software K190780 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solution USA, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k191148/ 2019-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k191148-medtronic-hv-r-bone-cement-kyphon-fda-510k.jpg K191148 - Medtronic HV-R™ Bone Cement, Kyphon™ Xpede™ Bone Cement, CD Horizon™ Fenestrated Screw Set K191148 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k191300/ 2019-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k191300-mectalock-ti-suture-anchor-fda-510k.jpg K191300 - MectaLock Ti Suture Anchor K191300 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Sep 2019. https://www.510kdatabase.net/k191419/ 2019-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k191419-revolution-peripheral-atherectomy-fda-510k.jpg K191419 - Revolution Peripheral Atherectomy System, Revolution Peripheral Atherectomy Guidewire K191419 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Rex Medical, L.P.. Cleared Sep 2019. https://www.510kdatabase.net/k191516/ 2019-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k191516-ali-interbody-fusion-system-fda-510k.jpg K191516 - Ali Interbody Fusion System K191516 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Raed M. Ali, M.D., Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k191518/ 2019-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k191518-co2-laser-system-fda-510k.jpg K191518 - CO2 Laser System K191518 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Gsd Tech Co., Ltd.. Cleared Sep 2019. https://www.510kdatabase.net/k191587/ 2019-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k191587-l360-thigh-system-fda-510k.jpg K191587 - L360 Thigh System K191587 is a FDA 510(k) cleared neurology medical device. Manufacturer: Bioness, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k191629/ 2019-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k191629-facelite-fda-510k.jpg K191629 - faceLITE K191629 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ismart Marketing Svcs, Ltd.. Cleared Sep 2019. https://www.510kdatabase.net/k191726/ 2019-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k191726-mont-blanc-mont-blanc-mis-spinal-systems-fda-510k.jpg K191726 - mont blanc & mont blanc MIS Spinal Systems K191726 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spineway SA. Cleared Sep 2019. https://www.510kdatabase.net/k192012/ 2019-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k192012-capillus-112-capillus-244-fda-510k.jpg K192012 - Capillus 112, Capillus 244 K192012 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Capillus. Cleared Sep 2019. https://www.510kdatabase.net/k192199/ 2019-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k192199-crc-pc-smart-chamber-k1-fda-510k.jpg K192199 - CRC PC Smart Chamber K1 K192199 is a FDA 510(k) cleared radiology medical device. Manufacturer: Capintec, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k192293/ 2019-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k192293-udr-592h-udr-596i-fda-510k.jpg K192293 - uDR 592h, uDR 596i K192293 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Sep 2019. https://www.510kdatabase.net/k183370/ 2019-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k183370-peramobile-and-perawatch-fda-510k.jpg K183370 - PeraMobile and PeraWatch K183370 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Perahealth, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k183521/ 2019-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k183521-cnap-monitor-fda-510k.jpg K183521 - CNAP Monitor K183521 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cnsystems Medizintechnik GmbH. Cleared Sep 2019. https://www.510kdatabase.net/k190815/ 2019-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k190815-brainscope-tbi-fda-510k.jpg K190815 - BrainScope TBI K190815 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainscope Company, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k191301/ 2019-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k191301-ceribell-pocket-eeg-device-fda-510k.jpg K191301 - Ceribell Pocket EEG Device K191301 is a FDA 510(k) cleared neurology medical device. Manufacturer: Ceribell, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k191355/ 2019-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k191355-3m-high-fluid-resistant-surgical-mask-fda-510k.jpg K191355 - 3M™ High Fluid-Resistant Surgical Mask and 3M™ High Fluid-Resistant Procedure Mask K191355 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Healthcare. Cleared Sep 2019. https://www.510kdatabase.net/k191605/ 2019-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k191605-neocis-guidance-system-ngs-fda-510k.jpg K191605 - Neocis Guidance System (NGS) K191605 is a FDA 510(k) cleared dental medical device. Manufacturer: Neocis, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k191619/ 2019-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k191619-turbotemp-ez-fda-510k.jpg K191619 - TurboTemp EZ K191619 is a FDA 510(k) cleared dental medical device. Manufacturer: Zest Anchors, LLC. Cleared Sep 2019. https://www.510kdatabase.net/k191811/ 2019-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k191811-catalyst-orthoscience-csr-shoulder-fda-510k.jpg K191811 - Catalyst OrthoScience CSR Shoulder System K191811 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Catalyst Orthoscience, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k181602/ 2019-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k181602-pioneer-elite-diode-laser-fda-510k.jpg K181602 - Pioneer Elite Diode Laser K181602 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: CAO Group, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k181614/ 2019-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k181614-sterling-supreme-diode-laser-fda-510k.jpg K181614 - Sterling Supreme Diode Laser K181614 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: CAO Group, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k183268/ 2019-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k183268-ai-rad-companion-cardiovascular-fda-510k.jpg K183268 - AI-Rad Companion (Cardiovascular) K183268 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k190484/ 2019-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k190484-bh-medical-dental-barrier-sleeves-and-fda-510k.jpg K190484 - BH Medical Dental Barrier Sleeves and Barrier Film K190484 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bh Medical Products Co., Ltd.. Cleared Sep 2019. https://www.510kdatabase.net/k190683/ 2019-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k190683-external-counterpulsation-system-fda-510k.jpg K190683 - External Counterpulsation System K190683 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vamed Medical Instrument Co., Ltd.. Cleared Sep 2019. https://www.510kdatabase.net/k191013/ 2019-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k191013-welch-allyn-diagnostic-cardiology-fda-510k.jpg K191013 - Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option K191013 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Welch Allyn, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k191945/ 2019-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k191945-kowa-nonmyd-8-fda-510k.jpg K191945 - KOWA nonmyd 8 K191945 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Kowa Company , Ltd.. Cleared Sep 2019. https://www.510kdatabase.net/k181601/ 2019-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k181601-precise-shp-diode-laser-fda-510k.jpg K181601 - Precise SHP Diode Laser K181601 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: CAO Group, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k183444/ 2019-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k183444-cenorin-610-washer-pasteurizershigh-fda-510k.jpg K183444 - Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector K183444 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cenorin, LLC. Cleared Sep 2019. https://www.510kdatabase.net/k190668/ 2019-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k190668-encompass-15-channel-head-coil-3t-fda-510k.jpg K190668 - Encompass 15 Channel Head Coil, 3T K190668 is a FDA 510(k) cleared radiology medical device. Manufacturer: Qfix. Cleared Sep 2019. https://www.510kdatabase.net/k191354/ 2019-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k191354-ti3z-cervical-interbody-system-fda-510k.jpg K191354 - Ti3Z Cervical Interbody System K191354 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zavation Medical Products, LLC. Cleared Sep 2019. https://www.510kdatabase.net/k191421/ 2019-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k191421-sofacia-system-fda-510k.jpg K191421 - Sofacia System K191421 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sofwave Medical, Ltd.. Cleared Sep 2019. https://www.510kdatabase.net/k192172/ 2019-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k192172-connected-or-hub-with-device-and-voice-fda-510k.jpg K192172 - Connected OR Hub with Device and Voice Control K192172 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker. Cleared Sep 2019. https://www.510kdatabase.net/k183215/ 2019-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k183215-focus-tens-therapy-model-pm710-m-l-fda-510k.jpg K183215 - Focus TENS Therapy, Model PM710-M/-L K183215 is a FDA 510(k) cleared neurology medical device. Manufacturer: Omron Healthcare, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k181986/ 2019-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k181986-klinly-ultrasonic-tongue-cleaner-fda-510k.jpg K181986 - Klinly Ultrasonic Tongue Cleaner K181986 is a FDA 510(k) cleared dental medical device. Manufacturer: Kea Products, Ltd.. Cleared Sep 2019. https://www.510kdatabase.net/k182355/ 2019-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k182355-secret-rf-smartcure-applicator-with-fda-510k.jpg K182355 - Secret RF Smartcure Applicator with electrodes K182355 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ilooda Co,., Ltd.. Cleared Sep 2019. https://www.510kdatabase.net/k182751/ 2019-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k182751-reusable-temperature-probe-fda-510k.jpg K182751 - Reusable Temperature Probe K182751 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen Caremed Medical Technology Co., Ltd.. Cleared Sep 2019. https://www.510kdatabase.net/k182886/ 2019-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k182886-cytomics-fc-500-series-mpl-or-mcl-flow-fda-510k.jpg K182886 - Cytomics FC 500 Series (MPL or MCL) Flow Cytometer K182886 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter. Cleared Sep 2019. https://www.510kdatabase.net/k183027/ 2019-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k183027-steerable-catheter-control-system-fda-510k.jpg K183027 - Steerable catheter control system K183027 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Stereotaxis, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k183416/ 2019-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k183416-rhino-laryngo-videoscope-olympus-enf-vt3-fda-510k.jpg K183416 - Rhino-Laryngo Videoscope Olympus ENF-VT3 K183416 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Sep 2019. https://www.510kdatabase.net/k183516/ 2019-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k183516-pentax-medical-ultrasound-video-fda-510k.jpg K183516 - PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U K183516 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Pentax of America, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k183525/ 2019-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k183525-evis-eus-ultrasound-bronchofibervideosco-fda-510k.jpg K183525 - EVIS EUS Ultrasound Bronchofibervideoscope Olympus BF-UC190F K183525 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Sep 2019. https://www.510kdatabase.net/k183574/ 2019-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k183574-srx-handheld-doppler-dmx-handheld-fda-510k.jpg K183574 - SRX Handheld Doppler, DMX Handheld Doppler, Obstetric Probes, Vascular Probes K183574 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Huntleigh Healthcare , Ltd.. Cleared Sep 2019. https://www.510kdatabase.net/k183665/ 2019-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k183665-safety-needles-sterile-syringe-sterile-fda-510k.jpg K183665 - Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use K183665 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Micsafe Medical Technology Co., Ltd.. Cleared Sep 2019. https://www.510kdatabase.net/k190213/ 2019-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k190213-yikang-endotracheal-tube-fda-510k.jpg K190213 - Yikang Endotracheal Tube K190213 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Jiangxi Yikang Medical Instrument Group Co., Ltd.. Cleared Sep 2019. https://www.510kdatabase.net/k190250/ 2019-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k190250-microscope-navigation-fda-510k.jpg K190250 - Microscope Navigation K190250 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Sep 2019. https://www.510kdatabase.net/k190403/ 2019-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k190403-disposable-powder-free-nitrile-fda-510k.jpg K190403 - Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Blue, Tested for Use With Chemotherapy Drugs K190403 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ever Global (Vietnam) Enterprise Corporation. Cleared Sep 2019. https://www.510kdatabase.net/k190499/ 2019-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k190499-gem-flowcoupler-system-fda-510k.jpg K190499 - Gem FlowCoupler System K190499 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Baxter/ Synovis Micro Companies Alliance, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k191102/ 2019-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k191102-precision-s-4k-sinuscope-fda-510k.jpg K191102 - Precision S 4K Sinuscope K191102 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Stryker. Cleared Sep 2019. https://www.510kdatabase.net/k191121/ 2019-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k191121-apioc-efrofilcon-a-soft-hydrophilic-fda-510k.jpg K191121 - Apioc (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc P for Presbyopia (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc A for Astigmatism (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc AP (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens K191121 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Lentechs, LLC. Cleared Sep 2019. https://www.510kdatabase.net/k191294/ 2019-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k191294-transvaginal-access-platform-fda-510k.jpg K191294 - Transvaginal Access Platform K191294 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Applied Medical Resources Corp.. Cleared Sep 2019. https://www.510kdatabase.net/k191366/ 2019-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k191366-vacutore-airwater-bottle-tubing-fda-510k.jpg K191366 - Vacutore Air/Water Bottle Tubing K191366 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Smartdata Suzhou Co., Ltd.. Cleared Sep 2019. https://www.510kdatabase.net/k191392/ 2019-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k191392-acqmap-high-resolution-imaging-and-fda-510k.jpg K191392 - AcQMap High Resolution Imaging and Mapping System K191392 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Acutus Medical, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k191435/ 2019-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k191435-ipg-integrated-2540-cm-single-tined-fda-510k.jpg K191435 - IPG, integrated, 25/40 cm, single, tined, IPG, 2 cm, single 4, Lead (25/40 cm, 4, tined), Extension - 4 K191435 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nalu Medical, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k191528/ 2019-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k191528-venus-legacy-pro-device-fda-510k.jpg K191528 - Venus Legacy Pro Device K191528 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Venus Concept USA, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k191531/ 2019-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k191531-sure-fine-insulin-syringes-fda-510k.jpg K191531 - Sure-Fine Insulin Syringes K191531 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shina Med Corporation. Cleared Sep 2019. https://www.510kdatabase.net/k191577/ 2019-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k191577-willow-wearable-breast-pump-20-fda-510k.jpg K191577 - Willow Wearable Breast Pump 2.0 K191577 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Exploramed Nc7, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k191782/ 2019-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k191782-ttc-phantom-intramedullary-nail-system-fda-510k.jpg K191782 - TTC Phantom Intramedullary Nail System K191782 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paragon 28, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k191845/ 2019-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k191845-coronis-fusion-6mp-mdcc-6530-coronis-fda-510k.jpg K191845 - Coronis Fusion 6MP - MDCC-6530, Coronis Fusion 4MP - MDCC-4430, Intuitive Workflow Tools (IWT) K191845 is a FDA 510(k) cleared radiology medical device. Manufacturer: Barco N.V.. Cleared Sep 2019. https://www.510kdatabase.net/k192160/ 2019-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k192160-evo-platform-fda-510k.jpg K192160 - EVO Platform K192160 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Quanta System Spa. Cleared Sep 2019. https://www.510kdatabase.net/k192188/ 2019-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k192188-aquilion-one-tsx-306a3-v100-fda-510k.jpg K192188 - Aquilion ONE (TSX-306A/3) V10.0 K192188 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Sep 2019. https://www.510kdatabase.net/k192226/ 2019-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k192226-lumify-diagnostic-ultrasound-system-fda-510k.jpg K192226 - Lumify Diagnostic Ultrasound System K192226 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Health Care. Cleared Sep 2019. https://www.510kdatabase.net/k183419/ 2019-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k183419-evis-exera-iii-bronchovideoscope-fda-510k.jpg K183419 - EVIS EXERA III Bronchovideoscope Olympus BF-XT190 K183419 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Sep 2019. https://www.510kdatabase.net/k183433/ 2019-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k183433-fujifilm-ultrasonic-endoscope-fda-510k.jpg K183433 - FUJIFILM Ultrasonic Endoscope K183433 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fujifilm Corporation. Cleared Sep 2019. https://www.510kdatabase.net/k183563/ 2019-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k183563-holinwon-30-fda-510k.jpg K183563 - Holinwon 30 K183563 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wontech Co., Ltd.. Cleared Sep 2019. https://www.510kdatabase.net/k190383/ 2019-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k190383-gm501-wash-fda-510k.jpg K190383 - GM501 Wash K190383 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Hamilton Thorne, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k190899/ 2019-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k190899-bili-hut-fda-510k.jpg K190899 - bili-hut K190899 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Little Sparrows Technologies, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k190930/ 2019-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k190930-smartemp-x1-fda-510k.jpg K190930 - SmarTemp X1 K190930 is a FDA 510(k) cleared dental medical device. Manufacturer: Parkell, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k191004/ 2019-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k191004-advocate-non-contact-infrared-fda-510k.jpg K191004 - Advocate Non-Contact Infrared Thermometer K191004 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Broadmaster Biotech, Corp.. Cleared Sep 2019. https://www.510kdatabase.net/k191343/ 2019-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k191343-system-1-endo-liquid-chemical-fda-510k.jpg K191343 - SYSTEM 1 endo Liquid Chemical Sterilant Processing System,Model P6900 K191343 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Sep 2019. https://www.510kdatabase.net/k191625/ 2019-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k191625-persona-revision-knee-system-fda-510k.jpg K191625 - Persona Revision Knee System K191625 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k191710/ 2019-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k191710-flowtriever-retrievalaspiration-system-fda-510k.jpg K191710 - FlowTriever Retrieval/Aspiration System K191710 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inari Medical. Cleared Sep 2019. https://www.510kdatabase.net/k191853/ 2019-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k191853-dual-safety-pen-needle-fda-510k.jpg K191853 - Dual-Safety Pen Needle K191853 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Promisemed Hangzhou Meditech Co., Ltd.. Cleared Sep 2019. https://www.510kdatabase.net/k192020/ 2019-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k192020-celerity-hp-chemical-indicator-fda-510k.jpg K192020 - Celerity HP Chemical Indicator, Celerity Vaporized VH2O2 Process Indicator Adhesive Label, VERIFY V24 Self-Contained Biological Indicator Vial Label K192020 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Sep 2019. https://www.510kdatabase.net/k192119/ 2019-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k192119-3m-clarity-aligners-fda-510k.jpg K192119 - 3M Clarity Aligners K192119 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Sep 2019. https://www.510kdatabase.net/k192123/ 2019-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k192123-hightop-pregnancy-rapid-test-cassette-fda-510k.jpg K192123 - HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Rapid Test Strip, HIGHTOP Pregnancy Rapid Test Midstream K192123 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Qingdao Hightop Biotech Co., Ltd.. Cleared Sep 2019. https://www.510kdatabase.net/k192148/ 2019-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k192148-freedom-primary-pck-fda-510k.jpg K192148 - Freedom Primary PCK K192148 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Maxx Orthopedics, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k183347/ 2019-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k183347-k3-fda-510k.jpg K183347 - K3 K183347 is a FDA 510(k) cleared dental medical device. Manufacturer: Osstem Implant Co., Ltd.. Cleared Sep 2019. https://www.510kdatabase.net/k190758/ 2019-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k190758-opus-bulk-fill-aps-opus-bulk-fill-flow-fda-510k.jpg K190758 - Opus Bulk Fill APS, Opus Bulk Fill Flow APS K190758 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentscare Ltda. Cleared Sep 2019. https://www.510kdatabase.net/k190844/ 2019-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k190844-akesis-galaxy-fda-510k.jpg K190844 - Akesis Galaxy K190844 is a FDA 510(k) cleared radiology medical device. Manufacturer: Akesis, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k191034/ 2019-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k191034-vps-impression-material-fda-510k.jpg K191034 - VPS Impression Material K191034 is a FDA 510(k) cleared dental medical device. Manufacturer: Hygedent, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k191070/ 2019-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k191070-signia-small-diameter-reloads-fda-510k.jpg K191070 - Signia Small Diameter Reloads K191070 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien. Cleared Sep 2019. https://www.510kdatabase.net/k191179/ 2019-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k191179-myo-plus-fda-510k.jpg K191179 - Myo Plus K191179 is a FDA 510(k) cleared neurology medical device. Manufacturer: Otto Bock Healthcare Products GmbH. Cleared Sep 2019. https://www.510kdatabase.net/k191503/ 2019-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k191503-mobileray-pulse-se-digital-imaging-fda-510k.jpg K191503 - MobileRay Pulse SE Digital Imaging System K191503 is a FDA 510(k) cleared radiology medical device. Manufacturer: Portavision Medical, LLC. Cleared Sep 2019. https://www.510kdatabase.net/k191908/ 2019-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k191908-mts-imipenem-0016-256-gml-fda-510k.jpg K191908 - MTS Imipenem 0.016-256 µg/mL K191908 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Liofilchem S. R. L.. Cleared Sep 2019. https://www.510kdatabase.net/k192088/ 2019-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k192088-golnit-non-aborbable-ptfe-surgical-fda-510k.jpg K192088 - GOLNIT Non-aborbable PTFE Surgical Suture K192088 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Antarma, LLC Dba Golnit Sutures. Cleared Sep 2019. https://www.510kdatabase.net/k192116/ 2019-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k192116-human-iga-liquid-reagent-kit-for-use-fda-510k.jpg K192116 - Human IgA liquid reagent kit for Use on SPAPlus K192116 is a FDA 510(k) cleared immunology medical device. Manufacturer: The Binding Site Group , Ltd.. Cleared Sep 2019. https://www.510kdatabase.net/k192155/ 2019-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k192155-smith-nephew-dyonics-25-fluid-fda-510k.jpg K192155 - Smith & Nephew DYONICS 25 Fluid Management System K192155 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k192156/ 2019-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k192156-cartiva-sci-instrumentation-set-fda-510k.jpg K192156 - Cartiva SCI instrumentation set K192156 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Cartiva, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k182765/ 2019-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k182765-5cc-neuraxial-slip-tip-glass-fda-510k.jpg K182765 - 5cc Neuraxial Slip Tip Glass Syringe,5cc Neuraxial Lock Tip Glass Syringe,5cc Neuraxial Additive Slip Tip Glass Syringe,10cc Neuraxial Slip Tip Glass Syringe,10cc Neuraxial Lock Tip Glass Syringe K182765 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Top Corporation. Cleared Sep 2019. https://www.510kdatabase.net/k183438/ 2019-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k183438-geomed-vascular-dilators-fda-510k.jpg K183438 - Geomed Vascular Dilators K183438 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Geomed Medizin-Technik GmbH & Co.. Cleared Sep 2019. https://www.510kdatabase.net/k191500/ 2019-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k191500-nuvasive-acp-system-fda-510k.jpg K191500 - NuVasive® ACP System K191500 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Sep 2019. https://www.510kdatabase.net/k191617/ 2019-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k191617-syntec-tibial-nail-system-fda-510k.jpg K191617 - Syntec Tibial Nail System K191617 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Syntec Scientific Corporation. Cleared Sep 2019. https://www.510kdatabase.net/k192106/ 2019-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k192106-acqref-introducer-sheath-fda-510k.jpg K192106 - AcQRef Introducer Sheath K192106 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Acutus Medical, Inc.. Cleared Sep 2019. https://www.510kdatabase.net/k183407/ 2019-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k183407-triton-cage-fda-510k.jpg K183407 - Triton Cage K183407 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medyssey USA, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k183475/ 2019-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k183475-t1-cs-t1-c-fda-510k.jpg K183475 - T1-CS, T1-C K183475 is a FDA 510(k) cleared radiology medical device. Manufacturer: Osstem Implant Co., Ltd.. Cleared Aug 2019. https://www.510kdatabase.net/k190449/ 2019-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k190449-visera-elite-ii-video-system-center-fda-510k.jpg K190449 - Visera Elite II Video System Center, Visera Elite II HD 3CMOS Autoclavable Camera Head, Visera Elite II 3CMOS Camera Head K190449 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Aug 2019. https://www.510kdatabase.net/k190702/ 2019-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k190702-lumipulse-g-whole-pth-fda-510k.jpg K190702 - Lumipulse G whole PTH K190702 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Fujirebio Diagnostics,Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k190719/ 2019-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k190719-artemis-eye-system-fda-510k.jpg K190719 - Artemis Eye System K190719 is a FDA 510(k) cleared neurology medical device. Manufacturer: Penumbra, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k190810/ 2019-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k190810-opera-opera-eco-fda-510k.jpg K190810 - OPERA, OPERA eco K190810 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Unimom.Co. Cleared Aug 2019. https://www.510kdatabase.net/k191245/ 2019-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k191245-yumizen-c1200-alp-yumizen-c1200-albumin-fda-510k.jpg K191245 - Yumizen C1200 ALP, Yumizen C1200 Albumin K191245 is a FDA 510(k) cleared chemistry medical device. Manufacturer: HORIBA ABX SAS. Cleared Aug 2019. https://www.510kdatabase.net/k191415/ 2019-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k191415-pathfinder-endoscope-overtube-fda-510k.jpg K191415 - Pathfinder Endoscope Overtube K191415 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Neptune Medical, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k191471/ 2019-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k191471-carnation-ambulatory-monitor-fda-510k.jpg K191471 - Carnation Ambulatory Monitor K191471 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bardy Diagnostics, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k191547/ 2019-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k191547-reliefband-fda-510k.jpg K191547 - ReliefBand K191547 is a FDA 510(k) cleared neurology medical device. Manufacturer: Reliefband Technologies, LLC. Cleared Aug 2019. https://www.510kdatabase.net/k191554/ 2019-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k191554-lightwalker-laser-system-family-fda-510k.jpg K191554 - LightWalker Laser System Family K191554 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Fotona D.O.O.. Cleared Aug 2019. https://www.510kdatabase.net/k191664/ 2019-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k191664-selectflex-072-neurovascular-access-fda-510k.jpg K191664 - SelectFlex 072 Neurovascular Access System K191664 is a FDA 510(k) cleared neurology medical device. Manufacturer: Q'Apel Medical. Cleared Aug 2019. https://www.510kdatabase.net/k191732/ 2019-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k191732-sutter-ravor-bipolar-electrodes-fda-510k.jpg K191732 - Sutter RaVoR Bipolar Electrodes K191732 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Sutter Medizintechnik GmbH. Cleared Aug 2019. https://www.510kdatabase.net/k191786/ 2019-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k191786-cyclops-anterior-cervical-plate-system-fda-510k.jpg K191786 - Cyclops™ Anterior Cervical Plate System K191786 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Degen Medical, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k192058/ 2019-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k192058-ev1000-clinical-platform-ni-ev1000-fda-510k.jpg K192058 - EV1000 Clinical Platform NI, EV1000 Clinical Platform K192058 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Aug 2019. https://www.510kdatabase.net/k192071/ 2019-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k192071-insitu-total-hip-system-fda-510k.jpg K192071 - iNSitu Total Hip System K192071 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Theken Companies, LLC. Cleared Aug 2019. https://www.510kdatabase.net/k192074/ 2019-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k192074-signature-one-system-fda-510k.jpg K192074 - Signature ONE System K192074 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthosoft Inc. (d/b/a) Zimmer CAS. Cleared Aug 2019. https://www.510kdatabase.net/k182219/ 2019-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k182219-sgs-dental-implants-system-fda-510k.jpg K182219 - SGS Dental Implants System K182219 is a FDA 510(k) cleared dental medical device. Manufacturer: Sgs International, Ltd.. Cleared Aug 2019. https://www.510kdatabase.net/k182382/ 2019-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k182382-nitrile-examination-powder-free-glove-fda-510k.jpg K182382 - Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink K182382 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Gmp Medicare Sdn Bhd (F25). Cleared Aug 2019. https://www.510kdatabase.net/k182811/ 2019-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k182811-gel-e-flex-fda-510k.jpg K182811 - gel-e Flex+ K182811 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Gel-E, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k183489/ 2019-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k183489-d2p-fda-510k.jpg K183489 - D2P K183489 is a FDA 510(k) cleared radiology medical device. Manufacturer: 3D Systems, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k183605/ 2019-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k183605-spine-trauma-navigation-fda-510k.jpg K183605 - Spine & Trauma Navigation K183605 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Brainlab AG. Cleared Aug 2019. https://www.510kdatabase.net/k190205/ 2019-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k190205-hemosphere-advanced-monitor-hemosphere-fda-510k.jpg K190205 - HemoSphere Advanced Monitor, HemoSphere Tissue Oximetry Module K190205 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Aug 2019. https://www.510kdatabase.net/k190236/ 2019-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k190236-o2vent-optima-fda-510k.jpg K190236 - O2Vent Optima K190236 is a FDA 510(k) cleared dental medical device. Manufacturer: Oventus Manufacturing Pty, Ltd.. Cleared Aug 2019. https://www.510kdatabase.net/k190613/ 2019-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k190613-bd-max-check-points-cpo-fda-510k.jpg K190613 - BD MAX Check-Points CPO K190613 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Check-Points Health B.V.. Cleared Aug 2019. https://www.510kdatabase.net/k190744/ 2019-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k190744-endoeye-hd-ii-wa50040a-wa50042a-fda-510k.jpg K190744 - ENDOEYE HD II (WA50040A, WA50042A, WA50050A, WA50052A) K190744 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Olympus Winter & Ibe GmbH. Cleared Aug 2019. https://www.510kdatabase.net/k191159/ 2019-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k191159-concentrator-with-single-battery-pack-fda-510k.jpg K191159 - Concentrator with Single battery pack, carry bag with shoulder strap, back pack shoulder straps, A, POC1 USB Bluetooth Dongle, POC1 Invacare Mobile Medical Application Accessory for use on iOS and Android Devices, Invacare Platinum Mobile Oxygen Concentrator with Connectivity K191159 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Invacare Corporation. Cleared Aug 2019. https://www.510kdatabase.net/k191281/ 2019-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k191281-omni-hysteroscope-omni-lok-cervical-seal-fda-510k.jpg K191281 - Omni Hysteroscope, Omni Lok cervical seal K191281 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Hologic, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k191319/ 2019-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k191319-dunamis-fixation-button-system-fda-510k.jpg K191319 - Dunamis Fixation Button System K191319 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Dunamis, LLC. Cleared Aug 2019. https://www.510kdatabase.net/k191439/ 2019-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k191439-overstitch-2-0-polypropylene-suture-fda-510k.jpg K191439 - OverStitch 2-0 Polypropylene Suture K191439 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Apollo Endosurgery. Cleared Aug 2019. https://www.510kdatabase.net/k191475/ 2019-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k191475-nobel-biocare-n1-pureset-tray-nobel-fda-510k.jpg K191475 - Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray, Prosthetic PureSet Plate K191475 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Nobel Biocare AB. Cleared Aug 2019. https://www.510kdatabase.net/k191939/ 2019-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k191939-yushan-x-ray-flat-panel-detector-fda-510k.jpg K191939 - Yushan X-Ray Flat Panel Detector K191939 is a FDA 510(k) cleared radiology medical device. Manufacturer: Innocare Optoelectronics Corp.. Cleared Aug 2019. https://www.510kdatabase.net/k192035/ 2019-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k192035-evaqmax-smoke-evacuation-system-fda-510k.jpg K192035 - EvaQMax Smoke Evacuation System K192035 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bio Protech, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k192036/ 2019-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k192036-clottriever-thrombectomy-system-fda-510k.jpg K192036 - ClotTriever Thrombectomy System K192036 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inari Medical. Cleared Aug 2019. https://www.510kdatabase.net/k192042/ 2019-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k192042-geistlich-bio-gide-geistlich-bio-gide-fda-510k.jpg K192042 - Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft and Geistlich Mucograft Seal K192042 is a FDA 510(k) cleared dental medical device. Manufacturer: Geistlich Pharma AG. Cleared Aug 2019. https://www.510kdatabase.net/k192054/ 2019-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k192054-endoskeleton-tas-plate-fda-510k.jpg K192054 - Endoskeleton TAS Plate K192054 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Titan Spine, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k192076/ 2019-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k192076-binary-anterior-cervical-plate-system-fda-510k.jpg K192076 - Binary® Anterior Cervical Plate System K192076 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Genesys Spine. Cleared Aug 2019. https://www.510kdatabase.net/k192107/ 2019-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k192107-clarius-ultrasound-scanner-fda-510k.jpg K192107 - Clarius Ultrasound Scanner K192107 is a FDA 510(k) cleared radiology medical device. Manufacturer: Clarius Mobile Health Corp.. Cleared Aug 2019. https://www.510kdatabase.net/k192159/ 2019-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k192159-voluson-e6-voluson-e8-voluson-e10-fda-510k.jpg K192159 - Voluson E6, Voluson E8, Voluson E10 K192159 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Aug 2019. https://www.510kdatabase.net/k182142/ 2019-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k182142-femme-applicator-tampon-fda-510k.jpg K182142 - FEMME Applicator Tampon K182142 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Jiangsu Yoai Technology Co., Ltd.. Cleared Aug 2019. https://www.510kdatabase.net/k182401/ 2019-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k182401-bolt-base-unit-bolt-non-invasive-blood-fda-510k.jpg K182401 - B.O.L.T Base Unit, B.O.L.T Non-Invasive Blood Pressure (NIBP) Cuff, B.O.L.T Infared Radiation Energy Technology(IRT) Thermometer probe, B.O.L.T Pulse Oximeter(SPO2) probe, B.O.L.T Gluchobin Blood Glucose, Total Cholesterol and Hemoglobin meter K182401 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Amzetta Technologies Private Limited. Cleared Aug 2019. https://www.510kdatabase.net/k183485/ 2019-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k183485-cryovizion-system-fda-510k.jpg K183485 - CryoVizion System K183485 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Cryos Technologies, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k190269/ 2019-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k190269-purelift-fda-510k.jpg K190269 - PureLift K190269 is a FDA 510(k) cleared neurology medical device. Manufacturer: Xtreem Pulse, LLC. Cleared Aug 2019. https://www.510kdatabase.net/k190437/ 2019-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k190437-delta-3300-fda-510k.jpg K190437 - Delta 3300 K190437 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Netech Corporation. Cleared Aug 2019. https://www.510kdatabase.net/k190704/ 2019-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k190704-signature-ceramic-femoral-head-fda-510k.jpg K190704 - Signature Ceramic Femoral Head K190704 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Signature Orthopaedics Pty, Ltd.. Cleared Aug 2019. https://www.510kdatabase.net/k190904/ 2019-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k190904-conformis-benefit-hip-system-fda-510k.jpg K190904 - Conformis BeneFIT Hip System K190904 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Conformis, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k191399/ 2019-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k191399-biolox-contoura-ceramic-femoral-head-fda-510k.jpg K191399 - BIOLOX CONTOURA Ceramic Femoral Head K191399 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Total Joint Othopedics, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k191414/ 2019-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k191414-exeter-centralizer-exeter-25mm-plug-fda-510k.jpg K191414 - EXETER Centralizer, EXETER 2.5mm Plug K191414 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Orthopaedics. Cleared Aug 2019. https://www.510kdatabase.net/k191424/ 2019-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k191424-interphalangeal-joint-fusion-device-fda-510k.jpg K191424 - Interphalangeal Joint Fusion Device Range K191424 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Neosteo. Cleared Aug 2019. https://www.510kdatabase.net/k191533/ 2019-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k191533-advia-centaur-testosterone-ii-tstii-fda-510k.jpg K191533 - ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG K191533 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k191569/ 2019-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k191569-implantcast-ic-bipolar-head-system-fda-510k.jpg K191569 - Implantcast ic-Bipolar Head System K191569 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Implantcast GmbH. Cleared Aug 2019. https://www.510kdatabase.net/k191778/ 2019-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k191778-omnia-medical-vbr-fda-510k.jpg K191778 - Omnia Medical VBR K191778 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Omnia Medical, LLC. Cleared Aug 2019. https://www.510kdatabase.net/k191780/ 2019-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k191780-ap5030-insufflator-with-insuflow-port-fda-510k.jpg K191780 - AP50/30 Insufflator with Insuflow Port K191780 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Lexion Medical, LLC. Cleared Aug 2019. https://www.510kdatabase.net/k191810/ 2019-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k191810-curiteva-pedicle-screw-system-fda-510k.jpg K191810 - Curiteva Pedicle Screw System K191810 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Curiteva, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k191077/ 2019-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k191077-affinity-cp-centrifugal-blood-pump-fda-510k.jpg K191077 - Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortive BioActive Surface, Medtronic External Drive Motor K191077 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k191107/ 2019-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k191107-plexus-fda-510k.jpg K191107 - Plexus K191107 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Alleva Medical (D.G), Ltd.. Cleared Aug 2019. https://www.510kdatabase.net/k191039/ 2019-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k191039-navigated-t2-stratosphere-inserters-fda-510k.jpg K191039 - Navigated T2 STRATOSPHERE Inserters and Navigated Templates K191039 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k191382/ 2019-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k191382-ips-emax-cad-abutment-solutions-extra-fda-510k.jpg K191382 - IPS e.max CAD Abutment Solutions- extra systems K191382 is a FDA 510(k) cleared dental medical device. Manufacturer: Ivoclar Vivadent, AG. Cleared Aug 2019. https://www.510kdatabase.net/k191427/ 2019-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k191427-halley-resin-system-fda-510k.jpg K191427 - Halley resin system K191427 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona. Cleared Aug 2019. https://www.510kdatabase.net/k192043/ 2019-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k192043-axios-stent-and-electrocautery-fda-510k.jpg K192043 - AXIOS Stent and Electrocautery Enhanced Delivery System K192043 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Aug 2019. https://www.510kdatabase.net/k183122/ 2019-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k183122-810nm-diode-laser-system-fda-510k.jpg K183122 - 810nm Diode Laser System K183122 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd. Cleared Aug 2019. https://www.510kdatabase.net/k182950/ 2019-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k182950-acare-suction-unit-fda-510k.jpg K182950 - Acare Suction Unit K182950 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Acare Technology Co., Ltd.. Cleared Aug 2019. https://www.510kdatabase.net/k183315/ 2019-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k183315-custmbite-dental-guard-fda-510k.jpg K183315 - CustMBite Dental Guard K183315 is a FDA 510(k) cleared dental medical device. Manufacturer: Dental Choice Holdings, LLC. Cleared Aug 2019. https://www.510kdatabase.net/k183544/ 2019-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k183544-efficient-care-3d-planning-fda-510k.jpg K183544 - Efficient Care 3D Planning K183544 is a FDA 510(k) cleared radiology medical device. Manufacturer: Orthosoft Inc. (d/b/a) Zimmer CAS. Cleared Aug 2019. https://www.510kdatabase.net/k183567/ 2019-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k183567-vyntussentrysuite-product-line-fda-510k.jpg K183567 - Vyntus/SentrySuite Product Line K183567 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Vyaire Medical. Cleared Aug 2019. https://www.510kdatabase.net/k183607/ 2019-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k183607-fujifilm-bronchoscope-fda-510k.jpg K183607 - FUJIFILM Bronchoscope K183607 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Fujifilm Corporation. Cleared Aug 2019. https://www.510kdatabase.net/k183684/ 2019-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k183684-libertas-taper-uncemented-femoral-stem-fda-510k.jpg K183684 - Libertas – Taper Uncemented Femoral Stem K183684 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Maxx Orthopedics, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k190127/ 2019-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k190127-reprocessed-livewire-steerable-fda-510k.jpg K190127 - Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheter K190127 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Innovative Health, LLC. Cleared Aug 2019. https://www.510kdatabase.net/k190459/ 2019-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k190459-hemoflow-f3-and-f4-dialyzers-fda-510k.jpg K190459 - Hemoflow F3 and F4 Dialyzers K190459 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC. Cleared Aug 2019. https://www.510kdatabase.net/k190593/ 2019-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k190593-zio-xt-ecg-monitoring-system-zio-at-fda-510k.jpg K190593 - Zio XT ECG Monitoring System, Zio AT ECG Monitoring System K190593 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: iRhythm Technologies, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k190813/ 2019-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k190813-crossbay-cervical-dilator-catheter-fda-510k.jpg K190813 - CrossBay Cervical Dilator Catheter System K190813 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Crossbay Medical. Cleared Aug 2019. https://www.510kdatabase.net/k191063/ 2019-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k191063-1-step-culture-medium-fda-510k.jpg K191063 - 1-Step Culture Medium K191063 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shenzhen Vitavitro Biotech Co., Ltd.. Cleared Aug 2019. https://www.510kdatabase.net/k191119/ 2019-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k191119-ekosonic-endovascular-device-fda-510k.jpg K191119 - EkoSonic Endovascular Device K191119 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Btg International, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k191130/ 2019-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k191130-customized-contour-implant-fda-510k.jpg K191130 - Customized Contour Implant K191130 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Implantech Associates, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k191177/ 2019-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k191177-lens-4k-camera-control-unit-wifi-lens-fda-510k.jpg K191177 - LENS 4K Camera Control Unit - Wifi, LENS 4K Camera Control Unit - Non-Wifi, LENS 4K Camera Head K191177 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith and Nephew, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k191180/ 2019-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k191180-electronic-blood-pressure-monitor-fda-510k.jpg K191180 - Electronic Blood Pressure Monitor K191180 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen AOJ Medical Technology Co., Ltd.. Cleared Aug 2019. https://www.510kdatabase.net/k191412/ 2019-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k191412-variax-2-system-variax-2-mini-fragment-fda-510k.jpg K191412 - VariAx 2 System, VariAx 2 Mini Fragment System K191412 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker GmbH. Cleared Aug 2019. https://www.510kdatabase.net/k191809/ 2019-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k191809-mts-imipenem-relebactam-00024-324-gml-fda-510k.jpg K191809 - MTS Imipenem-relebactam 0.002/4-32/4 µg/mL K191809 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Liofilchem S. R. L.. Cleared Aug 2019. https://www.510kdatabase.net/k191981/ 2019-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k191981-remedy-acetabular-cup-fda-510k.jpg K191981 - REMEDY Acetabular Cup K191981 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteoremedies, LLC. Cleared Aug 2019. https://www.510kdatabase.net/k191990/ 2019-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k191990-osw-aligner-system-fda-510k.jpg K191990 - OSW Aligner System K191990 is a FDA 510(k) cleared dental medical device. Manufacturer: Osw Manufacturing, LLC. Cleared Aug 2019. https://www.510kdatabase.net/k192047/ 2019-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k192047-rampart-one-lumbar-interbody-fusion-fda-510k.jpg K192047 - Rampart™ One Lumbar Interbody Fusion System K192047 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spineology, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k181888/ 2019-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k181888-osstell-beacon-fda-510k.jpg K181888 - Osstell Beacon K181888 is a FDA 510(k) cleared dental medical device. Manufacturer: Osstell AB. Cleared Aug 2019. https://www.510kdatabase.net/k190126/ 2019-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k190126-bendit27-steerable-microcatheter-fda-510k.jpg K190126 - Bendit2.7 Steerable Microcatheter K190126 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bend IT Technologies, Ltd.. Cleared Aug 2019. https://www.510kdatabase.net/k190402/ 2019-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k190402-triathlon-total-knee-system-additional-fda-510k.jpg K190402 - Triathlon Total Knee System-Additional Components K190402 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Orthopaedics (Aka Howmedica Osteonics Corp.). Cleared Aug 2019. https://www.510kdatabase.net/k190792/ 2019-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k190792-bb-613wp-fda-510k.jpg K190792 - BB-613WP K190792 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biobeat Technologies , Ltd.. Cleared Aug 2019. https://www.510kdatabase.net/k191242/ 2019-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k191242-healix-advance-sp-biocomposite-anchor-fda-510k.jpg K191242 - HEALIX ADVANCE SP BIOCOMPOSITE Anchor K191242 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International SARL. Cleared Aug 2019. https://www.510kdatabase.net/k191393/ 2019-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k191393-infinity-total-ankle-system-inbone-fda-510k.jpg K191393 - INFINITY Total Ankle System, INBONE Total Ankle System K191393 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Aug 2019. https://www.510kdatabase.net/k191953/ 2019-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k191953-etest-imipenemrelebactam-ipr-00024-324-fda-510k.jpg K191953 - ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL) K191953 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Biomerieux S.A.. Cleared Aug 2019. https://www.510kdatabase.net/k192021/ 2019-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k192021-ncb-polyaxial-locking-plate-system-fda-510k.jpg K192021 - NCB Polyaxial Locking Plate System K192021 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer GmbH. Cleared Aug 2019. https://www.510kdatabase.net/k183390/ 2019-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k183390-qnext-and-dg-pt-fda-510k.jpg K183390 - QNext and DG-PT K183390 is a FDA 510(k) cleared hematology medical device. Manufacturer: Diagnostic Grifols, S.A.. Cleared Aug 2019. https://www.510kdatabase.net/k190026/ 2019-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k190026-arrow-epidural-needle-kz-05500-007luer-fda-510k.jpg K190026 - Arrow Epidural Needle KZ-05500-007(Luer) K190026 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Teleflex Medical. Cleared Aug 2019. https://www.510kdatabase.net/k190044/ 2019-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k190044-vsp-orthopedics-system-fda-510k.jpg K190044 - VSP Orthopedics System K190044 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 3D Systems, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k190081/ 2019-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k190081-ras-12-rack-ras-12-long-rack-fda-510k.jpg K190081 - RAS 12 Rack, RAS 12 Long Rack K190081 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Aug 2019. https://www.510kdatabase.net/k191413/ 2019-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k191413-atriclip-laa-exclusion-system-with-fda-510k.jpg K191413 - AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip, AtriClip LAA Exclusion System with preloaded V-Clip K191413 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: AtriCure, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k191623/ 2019-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k191623-scanx-touchscanx-duo-touch-fda-510k.jpg K191623 - ScanX Touch/ScanX Duo Touch K191623 is a FDA 510(k) cleared radiology medical device. Manufacturer: Air Techniques, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k191948/ 2019-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k191948-glidescope-bflex-58-single-use-fda-510k.jpg K191948 - GlideScope BFlex 5.8 Single-Use Bronchoscope K191948 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Verathon Medical (Canada) Ulc. Cleared Aug 2019. https://www.510kdatabase.net/k182086/ 2019-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k182086-arco-fp-fda-510k.jpg K182086 - ARCO FP K182086 is a FDA 510(k) cleared radiology medical device. Manufacturer: A.T.S. Applicazione Tecnologie Speciali S.R.L.. Cleared Aug 2019. https://www.510kdatabase.net/k191561/ 2019-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k191561-exactech-equinoxe-humeral-augmented-fda-510k.jpg K191561 - Exactech Equinoxe Humeral Augmented Trays K191561 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k191936/ 2019-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k191936-insitu-total-hip-system-fda-510k.jpg K191936 - iNSitu Total Hip System K191936 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Thecken Companies, LLC. Cleared Aug 2019. https://www.510kdatabase.net/k183356/ 2019-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k183356-disposable-medical-device-self-seal-fda-510k.jpg K183356 - Disposable Medical Device Self-seal Sterilization Pouch, Disposable Medical Device Sterilization Reel Pouch K183356 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Weihai Xingtai Packaging Products Co., Ltd.. Cleared Aug 2019. https://www.510kdatabase.net/k190207/ 2019-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k190207-blood-pressure-monitor-fda-510k.jpg K190207 - Blood Pressure Monitor K190207 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Viatom Technology Co., Ltd.. Cleared Aug 2019. https://www.510kdatabase.net/k191339/ 2019-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k191339-zavation-ezspand-interbody-system-fda-510k.jpg K191339 - Zavation eZspand Interbody System K191339 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zavation Medical Products, LLC. Cleared Aug 2019. https://www.510kdatabase.net/k191342/ 2019-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k191342-crossroads-screw-system-fda-510k.jpg K191342 - CrossRoads Screw System K191342 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Crossroads Extemity Systems, LLC. Cleared Aug 2019. https://www.510kdatabase.net/k191985/ 2019-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k191985-optilite-iga-kit-fda-510k.jpg K191985 - Optilite IgA Kit K191985 is a FDA 510(k) cleared immunology medical device. Manufacturer: The Binding Site Group , Ltd.. Cleared Aug 2019. https://www.510kdatabase.net/k183108/ 2019-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k183108-combined-aerobika-opep-and-versapap-fda-510k.jpg K183108 - Combined Aerobika OPEP and VersaPAP device K183108 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Trudell Medical International. Cleared Aug 2019. https://www.510kdatabase.net/k183536/ 2019-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k183536-latex-powder-free-surgical-glove-with-fda-510k.jpg K183536 - Latex Powder Free Surgical Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove K183536 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hartalega NGC Sdn. Bhd.. Cleared Aug 2019. https://www.510kdatabase.net/k190722/ 2019-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k190722-trimax-implant-system-fda-510k.jpg K190722 - TriMAX Implant System K190722 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Crossroads Extemity Systems, LLC. Cleared Aug 2019. https://www.510kdatabase.net/k190735/ 2019-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k190735-eq-balance-fda-510k.jpg K190735 - EQ Balance K190735 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Upright Science, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k190853/ 2019-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k190853-vyntus-body-fda-510k.jpg K190853 - Vyntus BODY K190853 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Vyaire Medical, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k190988/ 2019-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k190988-gim-stim-otc-tensems-system-fda-510k.jpg K190988 - GIM-STIM OTC TENS/EMS System K190988 is a FDA 510(k) cleared neurology medical device. Manufacturer: Gemore Technology Co, Ltd.. Cleared Aug 2019. https://www.510kdatabase.net/k191079/ 2019-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k191079-piezon-built-in-kit-piezon-built-in-fda-510k.jpg K191079 - Piezon Built-in Kit, Piezon Built-in Kit LED K191079 is a FDA 510(k) cleared dental medical device. Manufacturer: E.M.S Electro Medical Systems S.A. Cleared Aug 2019. https://www.510kdatabase.net/k191349/ 2019-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k191349-980nm-diode-laser-therapy-device-fda-510k.jpg K191349 - 980nm Diode Laser Therapy Device K191349 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shanghai Apolo Medical Technology Co., Ltd.. Cleared Aug 2019. https://www.510kdatabase.net/k191504/ 2019-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k191504-powerdr-fda-510k.jpg K191504 - PowerDR K191504 is a FDA 510(k) cleared radiology medical device. Manufacturer: Radiology Information Systems, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k191609/ 2019-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k191609-tria-soft-ureteral-stent-fda-510k.jpg K191609 - Tria Soft Ureteral Stent K191609 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Aug 2019. https://www.510kdatabase.net/k191626/ 2019-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k191626-stat-profile-prime-es-comp-plus-fda-510k.jpg K191626 - Stat Profile Prime ES Comp Plus Analyzer System K191626 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Nova Biomedical Corporation. Cleared Aug 2019. https://www.510kdatabase.net/k191636/ 2019-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k191636-aptus-foot-system-fda-510k.jpg K191636 - APTUS Foot System K191636 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medartis AG. Cleared Aug 2019. https://www.510kdatabase.net/k191645/ 2019-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k191645-skr-4000-fda-510k.jpg K191645 - SKR 4000 K191645 is a FDA 510(k) cleared radiology medical device. Manufacturer: Konica Minolta, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k191899/ 2019-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k191899-glucose-hk-gen3-ise-indirect-na-for-fda-510k.jpg K191899 - Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions K191899 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Aug 2019. https://www.510kdatabase.net/k191924/ 2019-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k191924-safecare-thc-urine-strip-test-fda-510k.jpg K191924 - SAFECARE® THC Urine Strip Test K191924 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Safecare Biotech (Hangzhou) Co., Ltd.. Cleared Aug 2019. https://www.510kdatabase.net/k191933/ 2019-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k191933-compact-intuitiv-system-compact-fda-510k.jpg K191933 - COMPACT INTUITIV System, COMPACT INTUITIV Wireless Remote Control, COMPACT INTUITIV Four-Button Foot Pedal, COMPACT INTUITIV Closed-Toe Foot Pedal K191933 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Johnson & Johnson Surgical Vision, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k192018/ 2019-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k192018-endoskeleton-ta-interbody-fusion-fda-510k.jpg K192018 - Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic Interbody Fusion Device, Endoskeleton TO Interbody Fusion Device, Endoskeleton TT Interbody Fusion Device, Endoskeleton TC Interbody Fusion Device, Endoskeleton TCS Interbody Fusion Device, Endoskeleton TL Interbody Fusion Device K192018 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Titan Spine, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k183208/ 2019-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k183208-suprasorb-a-ag-r-fda-510k.jpg K183208 - Suprasorb A + Ag “R” K183208 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Speciality Fibres and Materials, Ltd.. Cleared Aug 2019. https://www.510kdatabase.net/k183230/ 2019-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k183230-onedraw-a1c-test-system-fda-510k.jpg K183230 - OneDraw A1C Test System K183230 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Drawbridge Health, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k183282/ 2019-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k183282-biovitals-analytics-engine-fda-510k.jpg K183282 - Biovitals Analytics Engine K183282 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biofourmis Singapore Pte., Ltd.. Cleared Aug 2019. https://www.510kdatabase.net/k190264/ 2019-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k190264-viola-fda-510k.jpg K190264 - Viola K190264 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Meditime Co., Ltd.. Cleared Aug 2019. https://www.510kdatabase.net/k190328/ 2019-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k190328-hct-empty-eva-container-pack-fda-510k.jpg K190328 - HCT Empty EVA Container Pack K190328 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Health Care Technologies. Cleared Aug 2019. https://www.510kdatabase.net/k190610/ 2019-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k190610-reprocessed-harmonic-focus-shears-fda-510k.jpg K190610 - Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology K190610 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sterilmed, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k190925/ 2019-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k190925-heartflow-ffrct-analysis-fda-510k.jpg K190925 - HeartFlow FFRct Analysis K190925 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: HeartFlow, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k190991/ 2019-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k190991-triathlon-tritanium-central-femoral-fda-510k.jpg K190991 - Triathlon Tritanium Central Femoral Cone Augment, Triathlon Femoral Distal Augment K190991 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp. (Aka Stryker Orthopaedics). Cleared Aug 2019. https://www.510kdatabase.net/k191200/ 2019-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k191200-tulsa-pro-system-fda-510k.jpg K191200 - TULSA-PRO System K191200 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Profound Medical, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k191621/ 2019-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k191621-choicespine-octane-atp-spinal-implant-fda-510k.jpg K191621 - ChoiceSpine Octane A/T/P Spinal Implant System, ChoiceSpine Cervical Interbody Spacer System Ascendant PC, ChoiceSpine Cervical Interbody Spacer System Ascendant, ChoiceSpine Cervical Spacer System Blackhawk, ChoiceSpine Intervertebral Fusion Device Octane Straight, ChoiceSpine Intervertebral Fusion Device Octane Straight PC, ChoiceSpine VEO Laterial Access & Interbody Fusion System K191621 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Choice Spine, LLC. Cleared Aug 2019. https://www.510kdatabase.net/k191916/ 2019-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k191916-stryker-cmf-medpor-priority-customized-fda-510k.jpg K191916 - Stryker CMF MEDPOR Priority Customized Implant Kit K191916 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker Leibinger GmbH & Co KG. Cleared Aug 2019. https://www.510kdatabase.net/k191922/ 2019-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k191922-acuson-p200-diagnostic-ultrasound-system-fda-510k.jpg K191922 - ACUSON P200 Diagnostic Ultrasound System K191922 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k182618/ 2019-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k182618-sleepimage-system-fda-510k.jpg K182618 - SleepImage System K182618 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Mycardio, LLC Dba Sleepimage.. Cleared Aug 2019. https://www.510kdatabase.net/k190063/ 2019-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k190063-servator-c-salf-solution-fda-510k.jpg K190063 - Servator C SALF Solution K190063 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: S.A.L.F. Spa. Cleared Aug 2019. https://www.510kdatabase.net/k190261/ 2019-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k190261-boss-toe-fixation-system-fda-510k.jpg K190261 - BOSS Toe Fixation System K190261 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrosurface, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k190689/ 2019-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k190689-signalmark-breast-marker-fda-510k.jpg K190689 - SignalMark Breast Marker K190689 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: View Point Medical, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k190849/ 2019-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k190849-is-iii-active-systems-narrow-type-fda-510k.jpg K190849 - IS-III active System_S-narrow Type K190849 is a FDA 510(k) cleared dental medical device. Manufacturer: Neobiotech Co., Ltd.. Cleared Aug 2019. https://www.510kdatabase.net/k190852/ 2019-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k190852-zurich-pressure-guidewire-system-model-fda-510k.jpg K190852 - Zurich Pressure Guidewire System Model 100 K190852 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Zurich Medical, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k191241/ 2019-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k191241-autostrut-fda-510k.jpg K191241 - AutoStrut K191241 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthospin. Cleared Aug 2019. https://www.510kdatabase.net/k191553/ 2019-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k191553-nuvaisve-reline-cervical-system-fda-510k.jpg K191553 - NuVaisve® Reline® Cervical System K191553 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Aug 2019. https://www.510kdatabase.net/k190428/ 2019-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k190428-elecsys-anti-hav-ii-fda-510k.jpg K190428 - Elecsys Anti-HAV II K190428 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Diagnostics. Cleared Aug 2019. https://www.510kdatabase.net/k190970/ 2019-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k190970-prostep-tbi-tailors-bunion-implant-fda-510k.jpg K190970 - PROSTEP™ TBI™ (Tailors Bunion Implant) System K190970 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Aug 2019. https://www.510kdatabase.net/k191024/ 2019-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k191024-xport-lens-fragmentation-system-fda-510k.jpg K191024 - xPORT Lens Fragmentation System K191024 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Carl Zeiss Meditec Cataract Technology, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k191376/ 2019-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k191376-modular-power-standing-system-fda-510k.jpg K191376 - Modular Power Standing System K191376 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Motion Concepts. Cleared Aug 2019. https://www.510kdatabase.net/k191582/ 2019-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k191582-cartesion-prime-fda-510k.jpg K191582 - Cartesion Prime K191582 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Aug 2019. https://www.510kdatabase.net/k191731/ 2019-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k191731-instylla-microcatheter-fda-510k.jpg K191731 - Instylla Microcatheter K191731 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Instylla, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k183182/ 2019-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k183182-critical-care-suite-fda-510k.jpg K183182 - Critical Care Suite K183182 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems, LLC. Cleared Aug 2019. https://www.510kdatabase.net/k183316/ 2019-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k183316-dr-j-spinal-and-epidural-needles-fda-510k.jpg K183316 - Dr J Spinal and Epidural Needles K183316 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Dr. Japan Co., Ltd.. Cleared Aug 2019. https://www.510kdatabase.net/k190025/ 2019-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k190025-evol-si-joint-fusion-system-fda-510k.jpg K190025 - EVOL® -SI Joint Fusion System K190025 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Cutting Edge Spine, LLC. Cleared Aug 2019. https://www.510kdatabase.net/k190491/ 2019-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k190491-blue-sky-bio-zygomatic-implant-system-fda-510k.jpg K190491 - Blue Sky Bio Zygomatic Implant System K190491 is a FDA 510(k) cleared dental medical device. Manufacturer: Blue Sky Bio, LLC. Cleared Aug 2019. https://www.510kdatabase.net/k190870/ 2019-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k190870-cervical-spinal-truss-system-stand-fda-510k.jpg K190870 - Cervical Spinal Truss System-Stand Alone (CSTS-SA) K190870 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 4Web, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k191009/ 2019-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k191009-arsenal-plating-system-fda-510k.jpg K191009 - Arsenal Plating System K191009 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Trilliant Surgical. Cleared Aug 2019. https://www.510kdatabase.net/k191311/ 2019-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k191311-atec-lateral-interbody-system-fda-510k.jpg K191311 - ATEC Lateral Interbody System K191311 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k191494/ 2019-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k191494-facilis-spinal-system-fda-510k.jpg K191494 - Facilis™ Spinal System K191494 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Baui Biotech Co., Ltd.. Cleared Aug 2019. https://www.510kdatabase.net/k182881/ 2019-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k182881-bone-screw-bone-tack-fda-510k.jpg K182881 - Bone Screw, Bone Tack K182881 is a FDA 510(k) cleared dental medical device. Manufacturer: Osstem Implant Co., Ltd.. Cleared Aug 2019. https://www.510kdatabase.net/k183158/ 2019-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k183158-nxstage-cartridge-express-with-speedswap-fda-510k.jpg K183158 - NxStage Cartridge Express with Speedswap K183158 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Nxstage Medical, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k183203/ 2019-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k183203-elan-4-tools-fda-510k.jpg K183203 - ELAN 4 Tools K183203 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k183647/ 2019-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k183647-soltive-laser-systemsoltive-pro-fda-510k.jpg K183647 - SOLTIVE™ Laser System(SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™Laser Fibers, and Accessories) K183647 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Olympus Surgical Technologies America. Cleared Aug 2019. https://www.510kdatabase.net/k190371/ 2019-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k190371-morpheus-c-fda-510k.jpg K190371 - Morpheus-C K190371 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biogennix, LLC. Cleared Aug 2019. https://www.510kdatabase.net/k191114/ 2019-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k191114-ellipsys-vascular-access-system-fda-510k.jpg K191114 - Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Needle K191114 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Avenu Medical. Cleared Aug 2019. https://www.510kdatabase.net/k191233/ 2019-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k191233-arietta-750-fda-510k.jpg K191233 - ARIETTA 750 K191233 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hitachi Healthcare Americas. Cleared Aug 2019. https://www.510kdatabase.net/k191560/ 2019-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k191560-turnpike-catheter-fda-510k.jpg K191560 - Turnpike Catheter K191560 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vascular Solutions, LLC. Cleared Aug 2019. https://www.510kdatabase.net/k191792/ 2019-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k191792-versana-balance-fda-510k.jpg K191792 - Versana Balance K191792 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared Aug 2019. https://www.510kdatabase.net/k191798/ 2019-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k191798-versana-active-fda-510k.jpg K191798 - Versana Active K191798 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared Aug 2019. https://www.510kdatabase.net/k191884/ 2019-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k191884-dr-100s-fda-510k.jpg K191884 - DR 100s K191884 is a FDA 510(k) cleared radiology medical device. Manufacturer: Agfa N.V.. Cleared Aug 2019. https://www.510kdatabase.net/k181760/ 2019-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k181760-transit-pellets-fda-510k.jpg K181760 - Transit-Pellets K181760 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medifactia AB. Cleared Aug 2019. https://www.510kdatabase.net/k183312/ 2019-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k183312-conformity-stem-fda-510k.jpg K183312 - Conformity Stem K183312 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: United Orthopedic Corporation. Cleared Aug 2019. https://www.510kdatabase.net/k190385/ 2019-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k190385-colink-plating-system-fracture-and-fda-510k.jpg K190385 - CoLink Plating System, Fracture and Correction System, RTS Implant System, NeoSpan Compression Staple System K190385 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: In2bones USA, LLC. Cleared Aug 2019. https://www.510kdatabase.net/k190562/ 2019-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k190562-itotal-identity-cruciate-retaining-fda-510k.jpg K190562 - iTotal Identity Cruciate Retaining Knee Replacement System K190562 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Conformis, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k190674/ 2019-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k190674-refresh-relieva-for-contacts-fda-510k.jpg K190674 - REFRESH RELIEVA For CONTACTS K190674 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Allergan, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k190716/ 2019-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k190716-streamline-6491-unipolar-pediatric-fda-510k.jpg K190716 - Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead K190716 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic. Cleared Aug 2019. https://www.510kdatabase.net/k191257/ 2019-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k191257-erchonia-evrl-fda-510k.jpg K191257 - Erchonia EVRL K191257 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Erchonia Corporation. Cleared Aug 2019. https://www.510kdatabase.net/k191352/ 2019-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k191352-binx-health-io-ctng-assay-fda-510k.jpg K191352 - binx health io CT/NG Assay K191352 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Binx Health, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k191575/ 2019-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k191575-arx-spinal-system-fda-510k.jpg K191575 - ARx Spinal System K191575 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k183276/ 2019-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k183276-7d-surgical-system-fda-510k.jpg K183276 - 7D Surgical System K183276 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 7D Surgical, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k190650/ 2019-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k190650-revolution-centrifugal-blood-pump-fda-510k.jpg K190650 - Revolution Centrifugal Blood Pump K190650 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sorin Group Italia S.R.L.. Cleared Aug 2019. https://www.510kdatabase.net/k190885/ 2019-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k190885-elevation-spine-saber-c-system-fda-510k.jpg K190885 - Elevation Spine Saber-C System K190885 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Elevation Spine. Cleared Aug 2019. https://www.510kdatabase.net/k190893/ 2019-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k190893-non-invasive-hemodynamic-blood-fda-510k.jpg K190893 - Non-invasive Hemodynamic Blood Pressure Monitor K190893 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vita-Course Technologies Co., Ltd.. Cleared Aug 2019. https://www.510kdatabase.net/k191012/ 2019-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k191012-navigated-pedicle-access-kit-fda-510k.jpg K191012 - Navigated Pedicle Access Kit K191012 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Izi Medical Products, LLC. Cleared Aug 2019. https://www.510kdatabase.net/k191274/ 2019-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k191274-bonalive-granules-fda-510k.jpg K191274 - BonAlive Granules K191274 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Bonalive Biomaterials, Ltd.. Cleared Aug 2019. https://www.510kdatabase.net/k191394/ 2019-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k191394-illumisite-platform-fda-510k.jpg K191394 - ILLUMISITE Platform K191394 is a FDA 510(k) cleared radiology medical device. Manufacturer: Covidien, LLC. Cleared Aug 2019. https://www.510kdatabase.net/k191606/ 2019-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k191606-renovocath-fda-510k.jpg K191606 - RenovoCath K191606 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Renovorx, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k191840/ 2019-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k191840-peripheral-intravascular-lithotripsy-fda-510k.jpg K191840 - Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable Kit, IVL Connector Cable (Replacement) K191840 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shockwave Medical, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k191841/ 2019-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k191841-accurate-multi-panel-drug-urine-test-cup-fda-510k.jpg K191841 - Accurate Multi Panel Drug Urine Test Cup K191841 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Healstone Biotech, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k191871/ 2019-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k191871-15f-isleeve-introducer-set-14f-isleeve-fda-510k.jpg K191871 - 15F iSLEEVE Introducer Set, 14F iSLEEVE Introducer Set K191871 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Aug 2019. https://www.510kdatabase.net/k183120/ 2019-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k183120-embocube-embolization-gelatin-fda-510k.jpg K183120 - EmboCube Embolization Gelatin K183120 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biosphere Medical, S.A.. Cleared Aug 2019. https://www.510kdatabase.net/k183387/ 2019-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k183387-m3290b-patient-information-center-ix-fda-510k.jpg K183387 - M3290B Patient Information Center iX K183387 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Philips Medical Systems. Cleared Aug 2019. https://www.510kdatabase.net/k183458/ 2019-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k183458-exoplan-23-fda-510k.jpg K183458 - exoplan 2.3 K183458 is a FDA 510(k) cleared radiology medical device. Manufacturer: Exocad GmbH. Cleared Aug 2019. https://www.510kdatabase.net/k190502/ 2019-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k190502-enfit-oral-enteral-syringe-fda-510k.jpg K190502 - ENFit Oral / Enteral Syringe K190502 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Jiangsu Caina Medical Co.,Ltd. Cleared Aug 2019. https://www.510kdatabase.net/k190535/ 2019-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k190535-bimobile-dual-mobility-system-e-dur-fda-510k.jpg K190535 - BiMobile Dual Mobility System - E-Dur Inserts K190535 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Waldemar Link GmbH & Co. KG. Cleared Aug 2019. https://www.510kdatabase.net/k190992/ 2019-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k190992-orthopediatrics-pedifoot-deformity-fda-510k.jpg K190992 - OrthoPediatrics PediFoot Deformity Corrections System K190992 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OrthoPediatrics Corp.. Cleared Aug 2019. https://www.510kdatabase.net/k191158/ 2019-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k191158-the-aio-solution-fda-510k.jpg K191158 - The AIO Solution K191158 is a FDA 510(k) cleared radiology medical device. Manufacturer: Orfit Industries NV. Cleared Aug 2019. https://www.510kdatabase.net/k191295/ 2019-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k191295-percutaneous-introducer-needle-fda-510k.jpg K191295 - Percutaneous Introducer Needle K191295 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Progressive Medical, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k191423/ 2019-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k191423-normandy-vbr-system-fda-510k.jpg K191423 - Normandy VBR System K191423 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zavation Medical Products, LLC. Cleared Aug 2019. https://www.510kdatabase.net/k191565/ 2019-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k191565-endoskeleton-tcs-interbody-fusion-device-fda-510k.jpg K191565 - Endoskeleton TCS Interbody Fusion Device K191565 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Titan Spine, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k191781/ 2019-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k191781-wagner-sl-revision-stem-lateral-and-fda-510k.jpg K191781 - Wagner SL Revision Stem Lateral and Wagner Cone Prosthesis System K191781 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer GmbH. Cleared Aug 2019. https://www.510kdatabase.net/k191835/ 2019-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k191835-creo-stabilization-system-navigation-fda-510k.jpg K191835 - CREO Stabilization System, Navigation Instruments, ExcelsiusGPS Instruments K191835 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k183305/ 2019-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k183305-crossing-support-catheter-fda-510k.jpg K183305 - Crossing Support Catheter K183305 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Tractus Vascular, LLC. Cleared Aug 2019. https://www.510kdatabase.net/k183323/ 2019-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k183323-upj-occlusion-balloon-catheter-fda-510k.jpg K183323 - UPJ Occlusion Balloon Catheter K183323 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Aug 2019. https://www.510kdatabase.net/k190399/ 2019-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k190399-beddr-200-system-fda-510k.jpg K190399 - Beddr 200 System K190399 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Hancock Medical, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k191033/ 2019-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k191033-lunaguard-nighttime-dental-protector-fda-510k.jpg K191033 - LunaGuard Nighttime Dental Protector K191033 is a FDA 510(k) cleared dental medical device. Manufacturer: Mckeon Products. Cleared Aug 2019. https://www.510kdatabase.net/k191222/ 2019-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k191222-inclusive-titanium-abutments-fda-510k.jpg K191222 - Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV K191222 is a FDA 510(k) cleared dental medical device. Manufacturer: Prismatik Dentalcraft, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k191225/ 2019-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k191225-eeg-electrode-template-fda-510k.jpg K191225 - EEG Electrode Template K191225 is a FDA 510(k) cleared neurology medical device. Manufacturer: Rhythmlink International, LLC. Cleared Aug 2019. https://www.510kdatabase.net/k191262/ 2019-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k191262-absi-fda-510k.jpg K191262 - aBSI K191262 is a FDA 510(k) cleared radiology medical device. Manufacturer: Exini Diagnostics AB. Cleared Aug 2019. https://www.510kdatabase.net/k191496/ 2019-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k191496-tds-standard-solution-fda-510k.jpg K191496 - TDS Standard Solution K191496 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Mesa Laboratories, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k191766/ 2019-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k191766-vitek-2-ast-gram-negative-eravacycline-fda-510k.jpg K191766 - VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL) K191766 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k191877/ 2019-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k191877-fluorospeed-fda-510k.jpg K191877 - FLUOROspeed K191877 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shimadzu Corporation. Cleared Aug 2019. https://www.510kdatabase.net/k181154/ 2019-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k181154-med-link-wrist-digital-blood-pressure-fda-510k.jpg K181154 - Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood Pressure Monitor K181154 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Med-Link Electronics Tech Co., Ltd.. Cleared Aug 2019. https://www.510kdatabase.net/k181216/ 2019-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k181216-hamilton-t1-hamilton-c1-fda-510k.jpg K181216 - HAMILTON-T1, HAMILTON-C1 K181216 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Hamilton Medical AG. Cleared Aug 2019. https://www.510kdatabase.net/k183088/ 2019-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k183088-advia-centaur-erythropoietin-epo-assay-fda-510k.jpg K183088 - ADVIA Centaur Erythropoietin (EPO) assay K183088 is a FDA 510(k) cleared hematology medical device. Manufacturer: Axis-Shield Diagnostics Limited. Cleared Aug 2019. https://www.510kdatabase.net/k183091/ 2019-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k183091-elaris-pedicle-screw-system-fda-510k.jpg K183091 - Elaris Pedicle Screw System K183091 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinewelding AG. Cleared Aug 2019. https://www.510kdatabase.net/k183112/ 2019-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k183112-dilumen-endolumenal-interventional-fda-510k.jpg K183112 - DiLumen Endolumenal Interventional Knife (“DiLumen IK™”) K183112 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Lumendi, LLC. Cleared Aug 2019. https://www.510kdatabase.net/k190090/ 2019-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k190090-dynosense-vital-sign-measuring-system-fda-510k.jpg K190090 - DynoSense Vital Sign Measuring System K190090 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Dynosense Corp.. Cleared Aug 2019. https://www.510kdatabase.net/k190293/ 2019-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k190293-single-use-cytology-brush-bc-205d-fda-510k.jpg K190293 - Single Use Cytology Brush BC-205D K190293 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Aug 2019. https://www.510kdatabase.net/k190338/ 2019-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k190338-046-zenith-flex-fda-510k.jpg K190338 - 046 Zenith Flex K190338 is a FDA 510(k) cleared neurology medical device. Manufacturer: Inneuroco, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k191143/ 2019-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k191143-powerflow-implantable-apheresis-iv-port-fda-510k.jpg K191143 - PowerFlow Implantable Apheresis IV Port K191143 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k191217/ 2019-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k191217-jazz-pf-fda-510k.jpg K191217 - JAZZ PF K191217 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Implanet, S.A.. Cleared Aug 2019. https://www.510kdatabase.net/k191321/ 2019-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k191321-primelase-excellence-fda-510k.jpg K191321 - Primelase Excellence K191321 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: High Technology Products S.L.U. Cleared Aug 2019. https://www.510kdatabase.net/k191505/ 2019-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k191505-rezum-system-fda-510k.jpg K191505 - Rezum System K191505 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Nxthera (A Boston Scientific Company). Cleared Aug 2019. https://www.510kdatabase.net/k191546/ 2019-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k191546-epicardial-access-system-fda-510k.jpg K191546 - Epicardial Access System K191546 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baylis Medical Company, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k191602/ 2019-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k191602-apa-oxy-blade-fda-510k.jpg K191602 - APA Oxy Blade K191602 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Venner Medical (Singapore) Pte, Ltd.. Cleared Aug 2019. https://www.510kdatabase.net/k191741/ 2019-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k191741-intertape-polymer-inc-type-1-bismuth-fda-510k.jpg K191741 - Intertape Polymer Inc., Type 1 Bismuth Process Indicator Steam Sterilization Tape K191741 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Intertape Polymer, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k191813/ 2019-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k191813-mobilediagnost-wdr-22-fda-510k.jpg K191813 - MobileDiagnost wDR 2.2 K191813 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sedecal., Sa.. Cleared Aug 2019. https://www.510kdatabase.net/k182818/ 2019-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k182818-loqteq-va-calcaneus-plate-35-fda-510k.jpg K182818 - LOQTEQ VA Calcaneus Plate 3.5 K182818 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aap Implantate AG. Cleared Aug 2019. https://www.510kdatabase.net/k182871/ 2019-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k182871-mini-tens-therapy-device-fda-510k.jpg K182871 - Mini TENS Therapy Device K182871 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Jumper Medical Equipment Co., Ltd.. Cleared Aug 2019. https://www.510kdatabase.net/k183193/ 2019-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k183193-mreplus-software-fda-510k.jpg K183193 - MREplus+ Software K183193 is a FDA 510(k) cleared radiology medical device. Manufacturer: Resoundant, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k183590/ 2019-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k183590-single-use-reloadable-clip-applicator-fda-510k.jpg K183590 - Single Use Reloadable Clip Applicator, Clip, Long Clip, Short Clip, Super Short Clip K183590 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Aug 2019. https://www.510kdatabase.net/k190176/ 2019-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k190176-minamo-fda-510k.jpg K190176 - MINAMO K190176 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Asahi Intecc Co., Ltd.. Cleared Aug 2019. https://www.510kdatabase.net/k190887/ 2019-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k190887-leksell-vantage-stereotactic-system-fda-510k.jpg K190887 - Leksell Vantage Stereotactic System K190887 is a FDA 510(k) cleared neurology medical device. Manufacturer: Elekta Instrument AB. Cleared Aug 2019. https://www.510kdatabase.net/k191190/ 2019-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k191190-steerable-introducer-fda-510k.jpg K191190 - Steerable Introducer K191190 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Freudenberg Medical, LLC. Cleared Aug 2019. https://www.510kdatabase.net/k191192/ 2019-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k191192-surgtech-genoll-total-knee-system-fda-510k.jpg K191192 - SurgTech GENOLL Total Knee System K191192 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Surgtech, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k191214/ 2019-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k191214-jo-premium-jelly-original-personal-fda-510k.jpg K191214 - JO Premium Jelly Original Personal Lubricant K191214 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: United Consortium. Cleared Aug 2019. https://www.510kdatabase.net/k191267/ 2019-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k191267-imagingring-system-on-rails-fda-510k.jpg K191267 - ImagingRing System on Rails K191267 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medphoton GmbH. Cleared Aug 2019. https://www.510kdatabase.net/k191469/ 2019-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k191469-biotronik-stylets-fda-510k.jpg K191469 - Biotronik Stylets K191469 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biotronik, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k191499/ 2019-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k191499-maglumi-2000-25-oh-vitamin-d-fda-510k.jpg K191499 - MAGLUMI 2000 25-OH Vitamin D K191499 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.. Cleared Aug 2019. https://www.510kdatabase.net/k191559/ 2019-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k191559-aquashield-system-co2-aquashield-fda-510k.jpg K191559 - AquaShield System CO2, AquaShield System CO2-PENTAX, AquaShield System CO2-FUJIFILM K191559 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: United States Endoscopy Group, Inc.. Cleared Aug 2019. https://www.510kdatabase.net/k190672/ 2019-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k190672-stealthstation-synergy-cranial-s7-fda-510k.jpg K190672 - StealthStation Synergy Cranial S7 Software v.2.2.8, StealthStation Cranial Software v3.1.1 K190672 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Navigation, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k190732/ 2019-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k190732-p200txe-fda-510k.jpg K190732 - P200TxE K190732 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Optos Plc.. Cleared Jul 2019. https://www.510kdatabase.net/k190777/ 2019-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k190777-demetech-demeforce-nonabsorbable-fda-510k.jpg K190777 - DemeTECH DemeFORCE Nonabsorbable Surgical Suture K190777 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Demetech Corporation. Cleared Jul 2019. https://www.510kdatabase.net/k190891/ 2019-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k190891-fluobeam-lx-fda-510k.jpg K190891 - Fluobeam LX K190891 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Fluoptics. Cleared Jul 2019. https://www.510kdatabase.net/k191183/ 2019-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k191183-eyebox-fda-510k.jpg K191183 - EyeBOX K191183 is a FDA 510(k) cleared neurology medical device. Manufacturer: Oculogica, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k191510/ 2019-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k191510-noveos-immunoanalyzer-system-noveos-fda-510k.jpg K191510 - Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae K191510 is a FDA 510(k) cleared immunology medical device. Manufacturer: Hycor Biomedical. Cleared Jul 2019. https://www.510kdatabase.net/k191611/ 2019-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k191611-diode-laser-therapy-systems-fda-510k.jpg K191611 - Diode Laser Therapy Systems K191611 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wingderm Electro-Optics , Ltd.. Cleared Jul 2019. https://www.510kdatabase.net/k191761/ 2019-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k191761-mobius3d-fda-510k.jpg K191761 - Mobius3D K191761 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k191764/ 2019-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k191764-inion-biorestore-fda-510k.jpg K191764 - Inion BioRestore K191764 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Inion OY. Cleared Jul 2019. https://www.510kdatabase.net/k191773/ 2019-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k191773-gore-bio-a-tissue-reinforcement-fda-510k.jpg K191773 - GORE BIO-A Tissue Reinforcement K191773 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k191795/ 2019-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k191795-aocup-lens-case-with-aodisc-fda-510k.jpg K191795 - AOCup Lens Case with AODisc K191795 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Alcon Laboratories, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k191931/ 2019-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k191931-hardydisk-ast-imipenemrelebactam-1025g-fda-510k.jpg K191931 - HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25) K191931 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Hardy Diagnostics. Cleared Jul 2019. https://www.510kdatabase.net/k180295/ 2019-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k180295-hamilton-g5-fda-510k.jpg K180295 - Hamilton-G5 K180295 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Hamiton Medical AG. Cleared Jul 2019. https://www.510kdatabase.net/k181743/ 2019-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k181743-blood-transfer-accessory-bta-fda-510k.jpg K181743 - Blood Transfer Accessory (BTA) K181743 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Nsp Tech Pte, Ltd.. Cleared Jul 2019. https://www.510kdatabase.net/k181754/ 2019-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k181754-blood-collection-accessory-buca-fda-510k.jpg K181754 - Blood Collection Accessory (BUCA) K181754 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Nsp Tech Pte, Ltd.. Cleared Jul 2019. https://www.510kdatabase.net/k182089/ 2019-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k182089-powder-free-blue-nitrile-examination-fda-510k.jpg K182089 - Powder Free Blue Nitrile Examination Gloves - Tested for Use with Chemotherapy Drugs K182089 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Platinum Glove Industries Sdn. Bhd.. Cleared Jul 2019. https://www.510kdatabase.net/k183288/ 2019-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k183288-transcutaneous-electrical-nerve-fda-510k.jpg K183288 - Transcutaneous Electrical Nerve Stimulator K183288 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Kentro Medical Electronics Co., Ltd.. Cleared Jul 2019. https://www.510kdatabase.net/k183547/ 2019-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k183547-marinr-steerable-intracardiac-fda-510k.jpg K183547 - Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable Intracardiac Electrode Catheter, Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter K183547 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic. Cleared Jul 2019. https://www.510kdatabase.net/k190132/ 2019-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k190132-torqr-intracardiac-electrode-catheter-fda-510k.jpg K190132 - Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter K190132 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic. Cleared Jul 2019. https://www.510kdatabase.net/k190274/ 2019-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k190274-endotracheal-tube-fda-510k.jpg K190274 - Endotracheal Tube K190274 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Tianjin Medis Medical Device Co., Ltd.. Cleared Jul 2019. https://www.510kdatabase.net/k190291/ 2019-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k190291-addivation-medical-cervical-interbody-fda-510k.jpg K190291 - Addivation Medical Cervical Interbody System K190291 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Addivation Medical, LLC. Cleared Jul 2019. https://www.510kdatabase.net/k191454/ 2019-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k191454-atellica-ch-amylase2-amy2-fda-510k.jpg K191454 - Atellica CH Amylase_2 (AMY_2) K191454 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k191484/ 2019-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k191484-renuvionj-plasma-precise-handpiece-fda-510k.jpg K191484 - Renuvion/J-Plasma Precise Handpiece K191484 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Apyx Medical Corporation(Formerly Bovie Medical Corporation). Cleared Jul 2019. https://www.510kdatabase.net/k191768/ 2019-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k191768-axs-vecta-aspiration-system-fda-510k.jpg K191768 - AXS Vecta Aspiration System K191768 is a FDA 510(k) cleared neurology medical device. Manufacturer: Stryker Neurovascular. Cleared Jul 2019. https://www.510kdatabase.net/k183048/ 2019-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k183048-quantisal-ii-oral-fluid-collection-fda-510k.jpg K183048 - Quantisal II Oral Fluid Collection Device K183048 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Immunalysis Corporation. Cleared Jul 2019. https://www.510kdatabase.net/k190339/ 2019-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k190339-helioseal-f-plus-fda-510k.jpg K190339 - Helioseal F Plus K190339 is a FDA 510(k) cleared dental medical device. Manufacturer: Ivoclar Vivadent, AG. Cleared Jul 2019. https://www.510kdatabase.net/k190569/ 2019-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k190569-shaders-zr-fda-510k.jpg K190569 - Shaders ZR K190569 is a FDA 510(k) cleared dental medical device. Manufacturer: Digital Age Dental Lab. Cleared Jul 2019. https://www.510kdatabase.net/k190809/ 2019-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k190809-sample-imaging-for-senographe-pristina-fda-510k.jpg K190809 - Sample Imaging for Senographe Pristina K190809 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Jul 2019. https://www.510kdatabase.net/k190886/ 2019-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k190886-non-invasive-blood-pressure-fda-510k.jpg K190886 - Non-invasive blood pressure measurement systems K190886 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Joytech Healthcare Co. , Ltd.. Cleared Jul 2019. https://www.510kdatabase.net/k190907/ 2019-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k190907-zeus-elisa-borrelia-vlse1pepc10-iggigm-fda-510k.jpg K190907 - ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System K190907 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k191136/ 2019-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k191136-access-ct-fda-510k.jpg K191136 - Access CT K191136 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Healthcare (Suzhou) Co., Ltd.. Cleared Jul 2019. https://www.510kdatabase.net/k191154/ 2019-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k191154-hair-boom-69-fda-510k.jpg K191154 - Hair Boom 69 K191154 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wontech. Cleared Jul 2019. https://www.510kdatabase.net/k191240/ 2019-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k191240-zeus-elisa-borrelia-vlse1pepc10-iggigm-fda-510k.jpg K191240 - ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System K191240 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k191289/ 2019-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k191289-bone-screw-line-addition-fda-510k.jpg K191289 - Bone Screw Line Addition K191289 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Vilex IN Tennessee, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k191398/ 2019-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k191398-zeus-elisa-borrelia-vlse1pepc10-iggigm-fda-510k.jpg K191398 - ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System K191398 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k191535/ 2019-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k191535-colink-mini-plating-system-fda-510k.jpg K191535 - CoLink® Mini Plating System K191535 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: In2bones USA, LLC. Cleared Jul 2019. https://www.510kdatabase.net/k191797/ 2019-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k191797-biomarc-fiducial-marker-fda-510k.jpg K191797 - BiomarC Fiducial Marker K191797 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Carbon Medical Technologies. Cleared Jul 2019. https://www.510kdatabase.net/k190996/ 2019-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k190996-bonus-therapeutics-mixing-and-delivery-fda-510k.jpg K190996 - Bonus Therapeutics Mixing and Delivery System K190996 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Bonus Therapeutics , Ltd.. Cleared Jul 2019. https://www.510kdatabase.net/k182384/ 2019-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k182384-acr-lab-urine-analysis-test-system-fda-510k.jpg K182384 - ACR LAB Urine Analysis Test System K182384 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Healthy.Io, Ltd.. Cleared Jul 2019. https://www.510kdatabase.net/k182889/ 2019-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k182889-kls-martin-individual-patient-fda-510k.jpg K182889 - KLS Martin Individual Patient Solutions (IPS) Planning System K182889 is a FDA 510(k) cleared neurology medical device. Manufacturer: KLS-Martin L.P.. Cleared Jul 2019. https://www.510kdatabase.net/k183129/ 2019-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k183129-medtronic-total-hip-arthroplasty-system-fda-510k.jpg K183129 - Medtronic Total Hip Arthroplasty System K183129 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Advanced Energy. Cleared Jul 2019. https://www.510kdatabase.net/k183194/ 2019-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k183194-arthrex-eclipse-shoulder-prosthesis-fda-510k.jpg K183194 - Arthrex Eclipse Shoulder Prosthesis System K183194 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k183271/ 2019-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k183271-ai-rad-companion-pulmonary-fda-510k.jpg K183271 - AI-Rad Companion (Pulmonary) K183271 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k183280/ 2019-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k183280-powderfree-white-blue-sterilized-fda-510k.jpg K183280 - PowderFree White Blue Sterilized Nitrile Copolymer Examination Gloves Tested for use with chemotherapy drugs K183280 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Smart Glove Corporation Sdn. Bhd.. Cleared Jul 2019. https://www.510kdatabase.net/k183486/ 2019-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k183486-rapidvit-oocyte-rapidwarm-oocyte-fda-510k.jpg K183486 - RapidVit™ Oocyte, RapidWarm™ Oocyte K183486 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Vitrolife Sweden AB. Cleared Jul 2019. https://www.510kdatabase.net/k190062/ 2019-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k190062-statclave-g4-chamber-autoclave-fda-510k.jpg K190062 - STATCLAVE G4 Chamber Autoclave K190062 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Scican , Ltd.. Cleared Jul 2019. https://www.510kdatabase.net/k190533/ 2019-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k190533-mojo-2-full-face-non-vented-mask-mojo-fda-510k.jpg K190533 - Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-Vented K190533 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sleepnet Corporation. Cleared Jul 2019. https://www.510kdatabase.net/k190685/ 2019-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k190685-hair-growth-system-fda-510k.jpg K190685 - Hair Growth System K190685 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Xuzhou Kernel Medical Equipment Co., Ltd.. Cleared Jul 2019. https://www.510kdatabase.net/k190873/ 2019-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k190873-infrared-earforehead-thermometer-fda-510k.jpg K190873 - Infrared Ear/Forehead Thermometer K190873 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Joytech Healthcare Co. , Ltd.. Cleared Jul 2019. https://www.510kdatabase.net/k190949/ 2019-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k190949-scanx-barrier-envelopes-fda-510k.jpg K190949 - ScanX Barrier Envelopes K190949 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Air Techniques, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k191328/ 2019-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k191328-megadyne-foot-switch-fda-510k.jpg K191328 - Megadyne Foot Switch K191328 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Megadyne Medical Products, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k191396/ 2019-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k191396-yumizen-c1200-calcium-as-yumizen-c1200-fda-510k.jpg K191396 - Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe K191396 is a FDA 510(k) cleared chemistry medical device. Manufacturer: HORIBA ABX SAS. Cleared Jul 2019. https://www.510kdatabase.net/k191714/ 2019-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k191714-asahi-neurovascular-guide-wire-chikai-fda-510k.jpg K191714 - ASAHI Neurovascular Guide Wire CHIKAI X 014 soft K191714 is a FDA 510(k) cleared neurology medical device. Manufacturer: Asahi Intecc Co., Ltd.. Cleared Jul 2019. https://www.510kdatabase.net/k191733/ 2019-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k191733-the-zip-accessory-shuttle-for-fda-510k.jpg K191733 - The ZIP Accessory Shuttle for PleuraFlow System K191733 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Clearflow, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k191736/ 2019-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k191736-da-vinci-xxi-8mm-endoscope-plus-0-da-fda-510k.jpg K191736 - da Vinci X/Xi 8mm Endoscope Plus, 0, da Vinci X/Xi 8mm Endoscope Plus, 30 K191736 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical. Cleared Jul 2019. https://www.510kdatabase.net/k191777/ 2019-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k191777-revolution-ct-revolution-ct-es-fda-510k.jpg K191777 - Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition K191777 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems, LLC. Cleared Jul 2019. https://www.510kdatabase.net/k191817/ 2019-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k191817-activortho-continuous-compression-fda-510k.jpg K191817 - ActivOrtho Continuous Compression Screw System K191817 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Activortho, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k180845/ 2019-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k180845-maxima-electric-system-fda-510k.jpg K180845 - Maxima Electric System K180845 is a FDA 510(k) cleared dental medical device. Manufacturer: Handpiece Headquarters - Hpr, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k182659/ 2019-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k182659-galilei-g6-lens-professional-fda-510k.jpg K182659 - Galilei G6 Lens Professional K182659 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Sis Ag, Surgical Instrument Systems. Cleared Jul 2019. https://www.510kdatabase.net/k183017/ 2019-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k183017-remedy-femoral-component-84mm-remedy-fda-510k.jpg K183017 - Remedy Femoral Component 84mm, Remedy Stemmed Knee Spacer K183017 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteoremedies, LLC. Cleared Jul 2019. https://www.510kdatabase.net/k183066/ 2019-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k183066-the-powerwand-safety-introducer-with-fda-510k.jpg K183066 - The POWERWAND Safety Introducer with an Extended Dwell Catheter made of ChronoFlex C® with BioGUARD™ Technology-3 Fr, 4 Fr, and 5 Fr Model K183066 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Access Scientific, LLC. Cleared Jul 2019. https://www.510kdatabase.net/k183249/ 2019-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k183249-tritanium-x-pl-expandable-posterior-fda-510k.jpg K183249 - Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage K183249 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Spine. Cleared Jul 2019. https://www.510kdatabase.net/k190292/ 2019-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k190292-passio-pump-drainage-system-fda-510k.jpg K190292 - Passio Pump Drainage System K190292 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Bearpac Medical. Cleared Jul 2019. https://www.510kdatabase.net/k190774/ 2019-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k190774-rigidloop-titanium-button-rigidloop-fda-510k.jpg K190774 - RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL Implant K190774 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International SARL. Cleared Jul 2019. https://www.510kdatabase.net/k190819/ 2019-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k190819-silicone-phmb-foam-wound-dressing-fda-510k.jpg K190819 - Silicone PHMB Foam Wound Dressing K190819 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Advanced Medical Solutions, Ltd.. Cleared Jul 2019. https://www.510kdatabase.net/k190910/ 2019-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k190910-prismax-system-version-2-fda-510k.jpg K190910 - PrisMax System Version 2 K190910 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jul 2019. https://www.510kdatabase.net/k191173/ 2019-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k191173-emboshield-nav6-embolic-protection-fda-510k.jpg K191173 - Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires K191173 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Vascular. Cleared Jul 2019. https://www.510kdatabase.net/k191211/ 2019-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k191211-journey-ii-unicompartmental-knee-system-fda-510k.jpg K191211 - JOURNEY II Unicompartmental Knee System K191211 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k191789/ 2019-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k191789-stonetome-stone-removal-device-fda-510k.jpg K191789 - Stonetome Stone Removal Device K191789 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Jul 2019. https://www.510kdatabase.net/k182942/ 2019-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k182942-canon-oct-a1-fda-510k.jpg K182942 - Canon OCT-A1 K182942 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Canon, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k182984/ 2019-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k182984-maxitears-contacts-pf-fda-510k.jpg K182984 - MaxiTears Contacts PF K182984 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Omnivision AG. Cleared Jul 2019. https://www.510kdatabase.net/k190471/ 2019-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k190471-4cis-chiron-spinal-fixation-system-fda-510k.jpg K190471 - 4CIS® Chiron Spinal Fixation System K190471 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Solco Biomedical Co., Ltd.. Cleared Jul 2019. https://www.510kdatabase.net/k190587/ 2019-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k190587-coolrail-linear-pen-fda-510k.jpg K190587 - Coolrail Linear Pen K190587 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: AtriCure, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k190678/ 2019-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k190678-tempsure-fda-510k.jpg K190678 - TempSure K190678 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cynosure, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k191100/ 2019-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k191100-excelsiusgps-spine-11-interbody-module-fda-510k.jpg K191100 - ExcelsiusGPS Spine 1.1 Interbody Module K191100 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k191699/ 2019-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k191699-discovery-xr656-hd-with-volumerad-fda-510k.jpg K191699 - Discovery XR656 HD with VolumeRad K191699 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Hualun Medical Systems Co. , Ltd.. Cleared Jul 2019. https://www.510kdatabase.net/k191729/ 2019-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k191729-cobas-influenza-ab-nucleic-acid-test-fda-510k.jpg K191729 - Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System K191729 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Molecular Systems, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k190488/ 2019-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k190488-prolift-expandable-system-fda-510k.jpg K190488 - ProLift Expandable System K190488 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k190926/ 2019-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k190926-hammertoe-truss-system-hts-fda-510k.jpg K190926 - Hammertoe Truss System (HTS) K190926 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 4Web, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k190963/ 2019-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k190963-depuy-synthes-craniomaxillofacial-fda-510k.jpg K190963 - DePuy Synthes Craniomaxillofacial Sternal Devices - MR Conditional K190963 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes USA Products, LLC. Cleared Jul 2019. https://www.510kdatabase.net/k191662/ 2019-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k191662-vantage-orian-15t-mrt-1550-v45-fda-510k.jpg K191662 - Vantage Orian 1.5T, MRT-1550, V4.5 K191662 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Jul 2019. https://www.510kdatabase.net/k182817/ 2019-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k182817-cottonday-tampon-fda-510k.jpg K182817 - CottonDay Tampon K182817 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Taebong Co., Ltd.. Cleared Jul 2019. https://www.510kdatabase.net/k182985/ 2019-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k182985-roadrunner-pc-wire-guide-olcott-torque-fda-510k.jpg K182985 - Roadrunner PC Wire Guide, Olcott Torque Device K182985 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Jul 2019. https://www.510kdatabase.net/k190834/ 2019-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k190834-corin-optimized-position-system-fda-510k.jpg K190834 - Corin Optimized Position System Functional Hip Analysis (OPS FHA) K190834 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corin USA. Cleared Jul 2019. https://www.510kdatabase.net/k190975/ 2019-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k190975-plexus-scd110-sequential-compression-fda-510k.jpg K190975 - Plexus SCD110 Sequential Compression Device Sleeve K190975 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Midway Medical, LLC. Cleared Jul 2019. https://www.510kdatabase.net/k191078/ 2019-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k191078-baronova-access-sheath-kit-fda-510k.jpg K191078 - BAROnova Access Sheath Kit K191078 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baronova, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k191092/ 2019-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k191092-powder-free-vinyl-patient-examination-fda-510k.jpg K191092 - Powder-Free Vinyl Patient Examination Gloves, Yellow Color K191092 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Anhui Intco Medical Products Co., Ltd.. Cleared Jul 2019. https://www.510kdatabase.net/k191374/ 2019-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k191374-revival-modular-hip-stem-fda-510k.jpg K191374 - Revival Modular Hip Stem K191374 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corin U.S.A. Limited. Cleared Jul 2019. https://www.510kdatabase.net/k191593/ 2019-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k191593-digital-automatic-blood-pressure-fda-510k.jpg K191593 - Digital Automatic Blood Pressure Monitor MD36 Series K191593 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Grandway Technology (Shenzhen) Limited. Cleared Jul 2019. https://www.510kdatabase.net/k182487/ 2019-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k182487-cerusendo-microcatheter-fda-510k.jpg K182487 - CerusEndo Microcatheter K182487 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cerus Endovascular, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k191660/ 2019-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k191660-carto-3-ep-navigation-system-version-fda-510k.jpg K191660 - CARTO 3 EP Navigation System, Version 7.1 and Accessories K191660 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biosense Webster, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k182407/ 2019-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k182407-exceed-microneedling-device-fda-510k.jpg K182407 - Exceed Microneedling device K182407 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Mt. Derm GmbH. Cleared Jul 2019. https://www.510kdatabase.net/k182798/ 2019-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k182798-kidscore-d3-fda-510k.jpg K182798 - KIDScore D3 K182798 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Vitrolife A/S. Cleared Jul 2019. https://www.510kdatabase.net/k182940/ 2019-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k182940-surdial-dx-hemodialysis-system-fda-510k.jpg K182940 - Surdial DX Hemodialysis System K182940 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Nipro Medical Corporation. Cleared Jul 2019. https://www.510kdatabase.net/k182971/ 2019-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k182971-spaceoar-vue-hydrogel-fda-510k.jpg K182971 - SpaceOAR Vue Hydrogel K182971 is a FDA 510(k) cleared radiology medical device. Manufacturer: Augmenix, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k183349/ 2019-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k183349-aerodvx-system-fda-510k.jpg K183349 - AeroDVx System K183349 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sun Scientific, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k183545/ 2019-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k183545-anspach-helix-dissection-tools-fda-510k.jpg K183545 - Anspach Helix Dissection Tools K183545 is a FDA 510(k) cleared neurology medical device. Manufacturer: The Anspach Effort, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k190050/ 2019-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k190050-tech-dots-adhesive-and-conductive-gel-fda-510k.jpg K190050 - Tech Dots - Adhesive and conductive gel K190050 is a FDA 510(k) cleared neurology medical device. Manufacturer: Spes Medica Srl. Cleared Jul 2019. https://www.510kdatabase.net/k190260/ 2019-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k190260-sterizoner-vp4-sterilizer-fda-510k.jpg K190260 - STERIZONE(R) VP4 Sterilizer K190260 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Tso3, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k191117/ 2019-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k191117-nvisionvle-low-profile-optical-probe-fda-510k.jpg K191117 - NvisionVLE Low-profile Optical Probe K191117 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ninepoint Medical, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k191309/ 2019-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k191309-syngovia-mi-workflows-vb40a-scenium-fda-510k.jpg K191309 - syngo.via MI Workflows VB40A, Scenium K191309 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Soultions USA, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k191365/ 2019-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k191365-stat-profile-prime-es-comp-plus-fda-510k.jpg K191365 - Stat Profile Prime ES Comp Plus Analyzer System K191365 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Nova Biomedical Corporation. Cleared Jul 2019. https://www.510kdatabase.net/k191467/ 2019-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k191467-aplio-i900i800i700i600-diagnostic-fda-510k.jpg K191467 - Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V4.0 K191467 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Jul 2019. https://www.510kdatabase.net/k191633/ 2019-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k191633-infyna-chic-fda-510k.jpg K191633 - Infyna Chic K191633 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hollister Incorporated. Cleared Jul 2019. https://www.510kdatabase.net/k191648/ 2019-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k191648-mariner-mis-pedicle-screw-system-fda-510k.jpg K191648 - Mariner MIS Pedicle Screw System K191648 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared Jul 2019. https://www.510kdatabase.net/k191757/ 2019-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k191757-europa-pedicle-screw-system-fda-510k.jpg K191757 - EUROPA Pedicle Screw System K191757 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: MiRus, LLC. Cleared Jul 2019. https://www.510kdatabase.net/k181166/ 2019-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k181166-trilogy-evo-fda-510k.jpg K181166 - Trilogy Evo K181166 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k181170/ 2019-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k181170-trilogy-evo-universal-fda-510k.jpg K181170 - Trilogy Evo Universal K181170 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k182794/ 2019-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k182794-bionicgym-powered-muscle-stimulator-fda-510k.jpg K182794 - BionicGym Powered Muscle Stimulator K182794 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Medical Currents, Ltd.. Cleared Jul 2019. https://www.510kdatabase.net/k182908/ 2019-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k182908-ziacom-dental-implant-systems-fda-510k.jpg K182908 - Ziacom Dental Implant Systems K182908 is a FDA 510(k) cleared dental medical device. Manufacturer: Ziacom Medical, S.L.. Cleared Jul 2019. https://www.510kdatabase.net/k183121/ 2019-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k183121-qraypen-fda-510k.jpg K183121 - Qraypen K183121 is a FDA 510(k) cleared dental medical device. Manufacturer: AIOBIO Co., Ltd.. Cleared Jul 2019. https://www.510kdatabase.net/k183532/ 2019-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k183532-latitud-hip-replacement-system-fda-510k.jpg K183532 - Latitud Hip Replacement System K183532 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Meril Healthcare Pvt. , Ltd.. Cleared Jul 2019. https://www.510kdatabase.net/k190343/ 2019-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k190343-silverlon-wound-contact-burn-contact-fda-510k.jpg K190343 - Silverlon Wound Contact, Burn Contact Dressings K190343 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Argentum Medical, LLC. Cleared Jul 2019. https://www.510kdatabase.net/k190427/ 2019-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k190427-immucise-fda-510k.jpg K190427 - Immucise K190427 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terumo Corporation. Cleared Jul 2019. https://www.510kdatabase.net/k190492/ 2019-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k190492-peralta-stone-removal-catheter-fda-510k.jpg K190492 - Peralta Stone Removal Catheter K190492 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Calcula Technologies, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k190680/ 2019-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k190680-favo-s-tlif-fda-510k.jpg K190680 - FAVO S-TLIF K190680 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Silony Medical GmbH. Cleared Jul 2019. https://www.510kdatabase.net/k190895/ 2019-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k190895-mountaineer-oct-spinal-system-summit-fda-510k.jpg K190895 - MOUNTAINEER OCT Spinal System, SUMMIT SI OCT Spinal Fixation System, SYMPHONY OCT System, SUMMIT Fixation System K190895 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International SARL. Cleared Jul 2019. https://www.510kdatabase.net/k191048/ 2019-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k191048-acusnare-polypectomy-snare-duckbill-fda-510k.jpg K191048 - AcuSnare Polypectomy Snare - Duckbill K191048 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Wilson-Cook Medical, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k191060/ 2019-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k191060-acist-cvi1-contrast-delivery-system-fda-510k.jpg K191060 - ACIST CVI1 Contrast Delivery System, A1000 Syringe Kit, A1000V Syringe Kit, BT2000 Manifold Kit, BT2000 Manifold Kit, AngioToiuch Hand Controller Kit K191060 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Acist Medical Systems, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k191140/ 2019-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k191140-montage-qs-settable-resorbable-fda-510k.jpg K191140 - MONTAGE-QS Settable, Resorbable Hemostatic Bone K191140 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Orthocon, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k191370/ 2019-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k191370-dreamed-advisor-pro-fda-510k.jpg K191370 - DreaMed Advisor Pro K191370 is a FDA 510(k) cleared chemistry medical device. Manufacturer: DreaMed Diabetes, Ltd.. Cleared Jul 2019. https://www.510kdatabase.net/k191598/ 2019-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k191598-aos-es-retrograde-femoral-nail-fda-510k.jpg K191598 - AOS ES Retrograde Femoral Nail K191598 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Advanced Orthopaedic Solutions, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k191615/ 2019-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k191615-huvitz-imaging-system-fda-510k.jpg K191615 - Huvitz Imaging System K191615 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Huvitz Co., Ltd.. Cleared Jul 2019. https://www.510kdatabase.net/k191755/ 2019-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k191755-spar-k-instruments-for-use-with-gemini-fda-510k.jpg K191755 - SPAR-K Instruments (for use with Gemini SL Total Knee System) K191755 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Waldemar Link GmbH & Co. KG. Cleared Jul 2019. https://www.510kdatabase.net/k182820/ 2019-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k182820-the-pod-fda-510k.jpg K182820 - The POD K182820 is a FDA 510(k) cleared dental medical device. Manufacturer: Advanced Facialdontics, LLC. Cleared Jul 2019. https://www.510kdatabase.net/k183270/ 2019-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k183270-silent-nite-sl-fda-510k.jpg K183270 - Silent Nite sl K183270 is a FDA 510(k) cleared dental medical device. Manufacturer: Prismatik Dentalcraft, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k191053/ 2019-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k191053-xtreme-loop-fda-510k.jpg K191053 - Xtreme-Loop K191053 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Xiros, Ltd.. Cleared Jul 2019. https://www.510kdatabase.net/k191068/ 2019-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k191068-powersculp-laser-lipolysis-system-fda-510k.jpg K191068 - Powersculp laser lipolysis system K191068 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wuhan Lotuxs Technology Co., Ltd.. Cleared Jul 2019. https://www.510kdatabase.net/k191167/ 2019-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k191167-fungitell-stat-fda-510k.jpg K191167 - Fungitell STAT K191167 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Associates of Cape Cod, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k191345/ 2019-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k191345-pegasus-system-fda-510k.jpg K191345 - Pegasus System K191345 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: A.M. Surgical, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k191578/ 2019-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k191578-advia-centaur-zika-test-advia-centaur-fda-510k.jpg K191578 - ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control K191578 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k191711/ 2019-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k191711-ortholoc-sps-shoulder-plating-system-fda-510k.jpg K191711 - ORTHOLOC™ SPS Shoulder Plating System K191711 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tornier, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k180992/ 2019-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k180992-biotex-fda-510k.jpg K180992 - Biotex K180992 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Purgo Biologics, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k183051/ 2019-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k183051-kaye-nephrostomy-tamponade-balloon-fda-510k.jpg K183051 - Kaye Nephrostomy Tamponade Balloon Catheter and Stent Set K183051 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Jul 2019. https://www.510kdatabase.net/k183572/ 2019-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k183572-fujifilm-endoscope-models-eg-760ct-ec-fda-510k.jpg K183572 - FUJIFILM Endoscope Models EG-760CT, EC-760P-V/L and EC-740T/L K183572 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fujifilm Corporation. Cleared Jul 2019. https://www.510kdatabase.net/k183663/ 2019-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k183663-microlife-digital-infrared-ear-fda-510k.jpg K183663 - Microlife Digital Infrared Ear Thermometer K183663 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Microlife Intellectual Property GmbH. Cleared Jul 2019. https://www.510kdatabase.net/k190150/ 2019-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k190150-sage-2-in-1-personal-lubricant-and-fda-510k.jpg K190150 - Sage 2-in-1 Personal Lubricant and Moisturizer K190150 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Fairhaven Health, LLC. Cleared Jul 2019. https://www.510kdatabase.net/k190163/ 2019-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k190163-alara-neuro-access-kit-fda-510k.jpg K190163 - ALARA Neuro Access Kit K190163 is a FDA 510(k) cleared neurology medical device. Manufacturer: SurGenTec, LLC. Cleared Jul 2019. https://www.510kdatabase.net/k190575/ 2019-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k190575-ibreastexam-fda-510k.jpg K190575 - iBreastExam K190575 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ue Lifesciences, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k191287/ 2019-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k191287-optifix-at-absorbable-fixation-system-fda-510k.jpg K191287 - OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology – 15 Fasteners K191287 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Davol Inc., Subsidiary of C.R. Bard. Cleared Jul 2019. https://www.510kdatabase.net/k191325/ 2019-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k191325-empowr-partial-knee-fda-510k.jpg K191325 - EMPOWR Partial Knee K191325 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Encore Medical, L.P.. Cleared Jul 2019. https://www.510kdatabase.net/k191608/ 2019-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k191608-impress-angiographic-catheter-fda-510k.jpg K191608 - Impress Angiographic Catheter K191608 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k191616/ 2019-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k191616-orthophos-s-fda-510k.jpg K191616 - Orthophos S K191616 is a FDA 510(k) cleared radiology medical device. Manufacturer: Dentsply Sirona. Cleared Jul 2019. https://www.510kdatabase.net/k182158/ 2019-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k182158-unid-patient-matched-plif-cage-fda-510k.jpg K182158 - UNiD Patient-matched PLIF cage K182158 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medicrea International SA. Cleared Jul 2019. https://www.510kdatabase.net/k182455/ 2019-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k182455-ab-dental-devices-dental-implants-system-fda-510k.jpg K182455 - A.B. DENTAL DEVICES Dental Implants System K182455 is a FDA 510(k) cleared dental medical device. Manufacturer: A.B. Dental Device , Ltd.. Cleared Jul 2019. https://www.510kdatabase.net/k182814/ 2019-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k182814-rael-tampon-fda-510k.jpg K182814 - Rael Tampon K182814 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Rael, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k190123/ 2019-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k190123-microport-cocr-femoral-heads-fda-510k.jpg K190123 - MicroPort CoCr Femoral Heads K190123 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Microport Orthopedics, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k190749/ 2019-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k190749-087-balloon-guide-catheter-system-fda-510k.jpg K190749 - 087 Balloon Guide Catheter System K190749 is a FDA 510(k) cleared neurology medical device. Manufacturer: Q'Apel. Cleared Jul 2019. https://www.510kdatabase.net/k191372/ 2019-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k191372-lyra-fda-510k.jpg K191372 - Lyra K191372 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Interacoustics A/S. Cleared Jul 2019. https://www.510kdatabase.net/k191635/ 2019-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k191635-optilite-igm-kit-fda-510k.jpg K191635 - Optilite IgM Kit K191635 is a FDA 510(k) cleared immunology medical device. Manufacturer: The Binding Site Group , Ltd.. Cleared Jul 2019. https://www.510kdatabase.net/k173974/ 2019-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k173974-drowzle-fda-510k.jpg K173974 - DROWZLE K173974 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Resonea, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k183325/ 2019-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k183325-modus-nav-fda-510k.jpg K183325 - Modus Nav K183325 is a FDA 510(k) cleared neurology medical device. Manufacturer: Synaptive Medical, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k182091/ 2019-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k182091-osstem-abutment-system-fda-510k.jpg K182091 - Osstem Abutment System K182091 is a FDA 510(k) cleared dental medical device. Manufacturer: Osstem Implant Co., Ltd.. Cleared Jul 2019. https://www.510kdatabase.net/k182714/ 2019-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k182714-novidia-bulk-fill-flow-composite-fda-510k.jpg K182714 - Novidia Bulk Fill Flow Composite K182714 is a FDA 510(k) cleared dental medical device. Manufacturer: Nobio , Ltd.. Cleared Jul 2019. https://www.510kdatabase.net/k182930/ 2019-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k182930-periolase-ndyag-pulsed-dental-laser-fda-510k.jpg K182930 - PerioLase Nd:YAG Pulsed Dental Laser System K182930 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Millennium Dental Technologies, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k183473/ 2019-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k183473-amsafer-pre-filled-normal-saline-flush-fda-510k.jpg K183473 - AMSafe(R) Pre-Filled Normal Saline Flush Syringe K183473 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Amsino International, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k190457/ 2019-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k190457-veriton-ct-whole-body-spectct-system-fda-510k.jpg K190457 - VERITON CT whole body SPECT/CT system K190457 is a FDA 510(k) cleared radiology medical device. Manufacturer: Spectrum Dynamics Medical, Ltd.. Cleared Jul 2019. https://www.510kdatabase.net/k190972/ 2019-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k190972-ambu-ascope-4-rhinolaryngo-intervention-fda-510k.jpg K190972 - Ambu aScope 4 RhinoLaryngo Intervention K190972 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Ambu A/S. Cleared Jul 2019. https://www.510kdatabase.net/k190976/ 2019-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k190976-radial-medical-compression-system-fda-510k.jpg K190976 - Radial Medical Compression System K190976 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Radial Medical, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k190999/ 2019-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k190999-sureform-45-curved-tip-sureform-45-fda-510k.jpg K190999 - SureForm 45 Curved Tip, SureForm 45 Gray Reload K190999 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k191050/ 2019-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k191050-magnetom-aera-and-magnetom-skyra-with-fda-510k.jpg K191050 - MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease (IHD) Workflow K191050 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k191259/ 2019-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k191259-stryker-crossflow-integrated-fda-510k.jpg K191259 - Stryker CrossFlow Integrated Arthroscopy Pump K191259 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker Corp.. Cleared Jul 2019. https://www.510kdatabase.net/k191272/ 2019-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k191272-wearable-device-wearable-package-fda-510k.jpg K191272 - Wearable Device, Wearable Package K191272 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Current Health , Ltd.. Cleared Jul 2019. https://www.510kdatabase.net/k191315/ 2019-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k191315-remington-medical-inc-automatic-fda-510k.jpg K191315 - Remington Medical, Inc. Automatic Cutting Needle (NAC) K191315 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Remington Medical, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k191317/ 2019-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k191317-stitchkit-fda-510k.jpg K191317 - StitchKit K191317 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Origami Surgical. Cleared Jul 2019. https://www.510kdatabase.net/k191585/ 2019-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k191585-intuition-structural-heart-module-fda-510k.jpg K191585 - iNtuition-Structural Heart Module K191585 is a FDA 510(k) cleared radiology medical device. Manufacturer: Terarecon,Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k191601/ 2019-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k191601-valleylab-ft10-electrosurgical-platform-fda-510k.jpg K191601 - Valleylab FT10 Electrosurgical Platform K191601 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien. Cleared Jul 2019. https://www.510kdatabase.net/k181418/ 2019-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k181418-scopeflow-puretm-fda-510k.jpg K181418 - ScopeFlow Pure(TM) K181418 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Partnership Medical Limited. Cleared Jul 2019. https://www.510kdatabase.net/k181457/ 2019-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k181457-endostreamtm-fda-510k.jpg K181457 - EndoStream(TM) K181457 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Partnership Medical Limited. Cleared Jul 2019. https://www.510kdatabase.net/k182854/ 2019-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k182854-gc-fujicem-2-improved-fda-510k.jpg K182854 - GC FujiCEM 2 (Improved) K182854 is a FDA 510(k) cleared dental medical device. Manufacturer: GC America, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k190229/ 2019-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k190229-stryker-peek-customized-cranial-fda-510k.jpg K190229 - Stryker PEEK Customized Cranial Implant Kit K190229 is a FDA 510(k) cleared neurology medical device. Manufacturer: Stryker. Cleared Jul 2019. https://www.510kdatabase.net/k190694/ 2019-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k190694-unifi-workspace-v100-fda-510k.jpg K190694 - Unifi Workspace v1.0.0 K190694 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hologic, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k190718/ 2019-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k190718-zygomatic-implants-fda-510k.jpg K190718 - Zygomatic Implants K190718 is a FDA 510(k) cleared dental medical device. Manufacturer: Jjgc Industria E Comercio DE Materiais Dentarios S.A.. Cleared Jul 2019. https://www.510kdatabase.net/k190960/ 2019-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k190960-nalu-lead-blank-50cm-fda-510k.jpg K190960 - Nalu Lead Blank (50cm) K190960 is a FDA 510(k) cleared neurology medical device. Manufacturer: Boston Scientific Neuromodulation. Cleared Jul 2019. https://www.510kdatabase.net/k191138/ 2019-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k191138-aeroform-tissue-expander-smooth-fda-510k.jpg K191138 - AeroForm Tissue Expander, Smooth K191138 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Airxpanders, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k191482/ 2019-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k191482-senhance-surgical-system-fda-510k.jpg K191482 - Senhance Surgical System K191482 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Transenterix, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k191534/ 2019-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k191534-id-now-influenza-a-b-2-fda-510k.jpg K191534 - ID NOW Influenza A & B 2 K191534 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Diagnostics Scarborough, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k191579/ 2019-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k191579-voyant-system-fda-510k.jpg K191579 - Voyant System K191579 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Viseon, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k191594/ 2019-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k191594-nuvis-battery-arthroscope-fda-510k.jpg K191594 - Nuvis Battery Arthroscope K191594 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Integrated Endoscopy, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k182471/ 2019-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k182471-scooter-fda-510k.jpg K182471 - Scooter K182471 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Tianjin Kepler Vehicle Industry Co. , Ltd.. Cleared Jul 2019. https://www.510kdatabase.net/k182829/ 2019-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k182829-scepter-mini-occlusion-balloon-catheter-fda-510k.jpg K182829 - Scepter Mini Occlusion Balloon Catheter K182829 is a FDA 510(k) cleared neurology medical device. Manufacturer: MicroVention, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k182875/ 2019-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k182875-deepct-fda-510k.jpg K182875 - DeepCT K182875 is a FDA 510(k) cleared radiology medical device. Manufacturer: Deep01 Limited. Cleared Jul 2019. https://www.510kdatabase.net/k183041/ 2019-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k183041-full-digital-colour-doppler-ultrasonic-fda-510k.jpg K183041 - Full Digital Colour Doppler Ultrasonic Diagnostic System K183041 is a FDA 510(k) cleared radiology medical device. Manufacturer: Wuhan Zoncare Bio-medical Electronics Co., Ltd.. Cleared Jul 2019. https://www.510kdatabase.net/k183079/ 2019-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k183079-conometric-abutments-fda-510k.jpg K183079 - Conometric Abutments K183079 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k183243/ 2019-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k183243-velofix-tlif-cage-fda-510k.jpg K183243 - Velofix TLIF Cage K183243 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: U&I Corporation. Cleared Jul 2019. https://www.510kdatabase.net/k183322/ 2019-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k183322-physiq-heart-rhythm-and-respiratory-fda-510k.jpg K183322 - physIQ Heart Rhythm and Respiratory Module K183322 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Physiq, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k190011/ 2019-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k190011-passport-series-patient-monitors-fda-510k.jpg K190011 - Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) K190011 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Jul 2019. https://www.510kdatabase.net/k190107/ 2019-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k190107-verisplint-fda-510k.jpg K190107 - VeriSplint K190107 is a FDA 510(k) cleared dental medical device. Manufacturer: Whip Mix Corporation. Cleared Jul 2019. https://www.510kdatabase.net/k190137/ 2019-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k190137-identify-fda-510k.jpg K190137 - Identify K190137 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k190528/ 2019-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k190528-marigen-wound-extra-fda-510k.jpg K190528 - MariGen Wound Extra K190528 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Kerecis Limited. Cleared Jul 2019. https://www.510kdatabase.net/k190620/ 2019-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k190620-speedicath-flex-coude-pro-fda-510k.jpg K190620 - SpeediCath Flex Coude Pro K190620 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Coloplast. Cleared Jul 2019. https://www.510kdatabase.net/k190801/ 2019-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k190801-presson-electrode-headset-fda-510k.jpg K190801 - PressOn Electrode Headset K190801 is a FDA 510(k) cleared neurology medical device. Manufacturer: Rhythmlink International, LLC. Cleared Jul 2019. https://www.510kdatabase.net/k190818/ 2019-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k190818-microlife-upper-arm-automatic-digital-fda-510k.jpg K190818 - Microlife Upper Arm Automatic Digital Blood Pressure Monitor K190818 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Microlife Intellectual Property GmbH. Cleared Jul 2019. https://www.510kdatabase.net/k191045/ 2019-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k191045-salvo-spine-system-fda-510k.jpg K191045 - Salvo™ Spine System K191045 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spine Wave, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k191408/ 2019-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k191408-nexxt-matrixx-system-fda-510k.jpg K191408 - Nexxt Matrixx System K191408 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nexxt Spine, LLC. Cleared Jul 2019. https://www.510kdatabase.net/k191541/ 2019-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k191541-vave-personal-ultrasound-system-fda-510k.jpg K191541 - Vave Personal Ultrasound System K191541 is a FDA 510(k) cleared radiology medical device. Manufacturer: Vave Health, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k191557/ 2019-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k191557-centrimag-acute-circulatory-support-fda-510k.jpg K191557 - CentriMag Acute Circulatory Support System K191557 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Thoratec Corporation (Now Part of Abbott). Cleared Jul 2019. https://www.510kdatabase.net/k191589/ 2019-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k191589-calprest-easycal-fda-510k.jpg K191589 - Calprest, EasyCal K191589 is a FDA 510(k) cleared immunology medical device. Manufacturer: Eurospital S.P.A.. Cleared Jul 2019. https://www.510kdatabase.net/k191592/ 2019-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k191592-calprestng-easycal-fda-510k.jpg K191592 - CalprestNG, EasyCal K191592 is a FDA 510(k) cleared immunology medical device. Manufacturer: Eurospital S.P.A.. Cleared Jul 2019. https://www.510kdatabase.net/k180994/ 2019-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k180994-securacath-10f-securacath-12f-fda-510k.jpg K180994 - SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F K180994 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Interrad Medical, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k181957/ 2019-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k181957-heat-sealing-sterilization-pouch-flat-fda-510k.jpg K181957 - Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch Gusseted, Heat Sealing Sterilization Pouch Roll Flat, Heat Sealing Sterilization Pouch Roll Gusseted K181957 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Tianchang Jiarui Packaging Material Co., Ltd.. Cleared Jul 2019. https://www.510kdatabase.net/k182163/ 2019-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k182163-shear-stress-therapeutics-sst-3000-fda-510k.jpg K182163 - Shear Stress Therapeutics SST 3000 K182163 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Shear Stress Therapeutics, LLC. Cleared Jul 2019. https://www.510kdatabase.net/k183623/ 2019-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k183623-lifesparc-pump-lifesparc-controller-fda-510k.jpg K183623 - LifeSPARC Pump, LifeSPARC Controller K183623 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cardiacassist, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k190969/ 2019-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k190969-endoscope-reprocessor-oer-elite-fda-510k.jpg K190969 - ENDOSCOPE REPROCESSOR OER-Elite K190969 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Jul 2019. https://www.510kdatabase.net/k191162/ 2019-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k191162-epilaze-multi-wavelength-laser-fda-510k.jpg K191162 - EpiLaze Multi-wavelength Laser K191162 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Rohrer Aesthetics, LLC. Cleared Jul 2019. https://www.510kdatabase.net/k191252/ 2019-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k191252-gem-flowcoupler-system-fda-510k.jpg K191252 - Gem FlowCoupler System K191252 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Baxter/ Synovis Micro Companies Alliance, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k180365/ 2019-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k180365-prama-white-implant-systems-fda-510k.jpg K180365 - PRAMA White Implant Systems K180365 is a FDA 510(k) cleared dental medical device. Manufacturer: Sweden & Martina S.P.A.. Cleared Jul 2019. https://www.510kdatabase.net/k181446/ 2019-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k181446-bard-power-injectable-implantable-fda-510k.jpg K181446 - Bard Power-Injectable Implantable Ports (PowerPorts®) K181446 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k181456/ 2019-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k181456-tuttnauer-horizontal-models4472559666906-fda-510k.jpg K181456 - Tuttnauer Horizontal Models:4472,5596,6690,66120,69120 and 69180 autoclaves K181456 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Tuttnauer , Ltd.. Cleared Jul 2019. https://www.510kdatabase.net/k182615/ 2019-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k182615-surgikor-dental-implant-system-fda-510k.jpg K182615 - Surgikor Dental Implant System K182615 is a FDA 510(k) cleared dental medical device. Manufacturer: Surgikor, LLC. Cleared Jul 2019. https://www.510kdatabase.net/k183050/ 2019-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k183050-glissant-intimate-lubricant-fda-510k.jpg K183050 - GLISSANT Intimate Lubricant K183050 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Vjuvenate, LLC. Cleared Jul 2019. https://www.510kdatabase.net/k183153/ 2019-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k183153-microwave-ablation-system-fda-510k.jpg K183153 - Microwave Ablation System K183153 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.. Cleared Jul 2019. https://www.510kdatabase.net/k190064/ 2019-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k190064-nview-system-1-fda-510k.jpg K190064 - nView system 1 K190064 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nview Medical, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k190277/ 2019-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k190277-provate-vaginal-support-fda-510k.jpg K190277 - ProVate Vaginal Support K190277 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Contipi Medical , Ltd.. Cleared Jul 2019. https://www.510kdatabase.net/k190286/ 2019-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k190286-materialise-glenoid-positioning-system-fda-510k.jpg K190286 - Materialise Glenoid Positioning System K190286 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Materialise NV. Cleared Jul 2019. https://www.510kdatabase.net/k190485/ 2019-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k190485-kawasumi-multiple-sample-adapter-with-fda-510k.jpg K190485 - Kawasumi Multiple Sample Adapter with Pre-Attached Holder (MBCH) K190485 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Kawasumi Laboratories, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k191384/ 2019-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k191384-raycare-23-fda-510k.jpg K191384 - RayCare 2.3 K191384 is a FDA 510(k) cleared radiology medical device. Manufacturer: RaySearch Laboratories AB (PUBL). Cleared Jul 2019. https://www.510kdatabase.net/k191580/ 2019-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k191580-bravos-afterloader-system-transfer-fda-510k.jpg K191580 - BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device K191580 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k182414/ 2019-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k182414-aesculap-sterilcontainertm-s2-system-fda-510k.jpg K182414 - Aesculap® SterilContainer(TM) S2 System K182414 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Aesculap, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k182901/ 2019-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k182901-aquilion-precision-tsx-304a1-and-2-v88-fda-510k.jpg K182901 - Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE K182901 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Jul 2019. https://www.510kdatabase.net/k182904/ 2019-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k182904-syngomr-applications-fda-510k.jpg K182904 - syngo.MR Applications K182904 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k190174/ 2019-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k190174-miethke-shunt-system-gav-20-and-sa-20-fda-510k.jpg K190174 - Miethke Shunt System GAV 2.0 and SA 2.0 Valves K190174 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k190254/ 2019-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k190254-mojo-2-full-face-vented-mask-veraseal-fda-510k.jpg K190254 - Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask K190254 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sleepnet Corporation. Cleared Jul 2019. https://www.510kdatabase.net/k190324/ 2019-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k190324-orthopediatrics-cannulated-screw-system-fda-510k.jpg K190324 - OrthoPediatrics Cannulated Screw System K190324 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OrthoPediatrics Corp.. Cleared Jul 2019. https://www.510kdatabase.net/k190456/ 2019-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k190456-btl-799-2l-fda-510k.jpg K190456 - BTL 799-2L K190456 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: BTL Industries, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k190498/ 2019-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k190498-fortilink-ibf-system-with-tetrafuse3d-fda-510k.jpg K190498 - Fortilink® IBF System with TETRAfuse®3D Technology, include the following designs: Fortilink®-TS IBF System, Fortilink®-L I BF System, Fortilink®-C IBF System K190498 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.). Cleared Jul 2019. https://www.510kdatabase.net/k190548/ 2019-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k190548-biomonitor-iii-remote-assistant-iii-fda-510k.jpg K190548 - BIOMONITOR III, Remote Assistant III K190548 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biotronik, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k190594/ 2019-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k190594-angiovac-c20-angiovac-c180-fda-510k.jpg K190594 - AngioVac C20, AngioVac C180 K190594 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: AngioDynamics, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k190645/ 2019-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k190645-arthrex-nanoscope-system-fda-510k.jpg K190645 - Arthrex NanoScope System K190645 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Arthrex, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k190924/ 2019-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k190924-revitive-medic-plus-revitive-advanced-2-fda-510k.jpg K190924 - Revitive Medic Plus, Revitive Advanced 2 K190924 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Actegy , Ltd.. Cleared Jul 2019. https://www.510kdatabase.net/k191238/ 2019-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k191238-zimmer-guide-wire-devices-fda-510k.jpg K191238 - Zimmer Guide Wire Devices K191238 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k191367/ 2019-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k191367-harrier-sa-lumbar-interbody-system-fda-510k.jpg K191367 - Harrier-SA Lumbar Interbody System K191367 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Choice Spine, LLC. Cleared Jul 2019. https://www.510kdatabase.net/k183149/ 2019-07-04 monthly 0.5 https://www.510kdatabase.net/og-image/k183149-blue-non-sterile-powder-free-nitrile-fda-510k.jpg K183149 - Blue Non-Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Low Dermatitis and Fentanyl Permeation Resistance Claim K183149 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Central Medicare Sdn Bhd. Cleared Jul 2019. https://www.510kdatabase.net/k190950/ 2019-07-04 monthly 0.5 https://www.510kdatabase.net/og-image/k190950-medline-level-2-surgical-gown-eclipse-fda-510k.jpg K190950 - Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced), Medline Level 3 Surgical Gown (Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced) K190950 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k180968/ 2019-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k180968-alphadent-implants-dental-implants-fda-510k.jpg K180968 - AlphaDent Implants Dental Implants System K180968 is a FDA 510(k) cleared dental medical device. Manufacturer: Alphadent Implants, Ltd.. Cleared Jul 2019. https://www.510kdatabase.net/k182580/ 2019-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k182580-novidia-flowable-composite-fda-510k.jpg K182580 - Novidia Flowable Composite K182580 is a FDA 510(k) cleared dental medical device. Manufacturer: Nobio , Ltd.. Cleared Jul 2019. https://www.510kdatabase.net/k182780/ 2019-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k182780-xp-composite-fda-510k.jpg K182780 - XP Composite K182780 is a FDA 510(k) cleared dental medical device. Manufacturer: S&C Polymer Silicon- Und Composite Spezialitaeten GmbH. Cleared Jul 2019. https://www.510kdatabase.net/k183058/ 2019-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k183058-arm-type-electronic-blood-pressure-fda-510k.jpg K183058 - Arm-type Electronic Blood Pressure Monitor K183058 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Bsx Technology Electronics Co., Ltd.. Cleared Jul 2019. https://www.510kdatabase.net/k190272/ 2019-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k190272-bluephase-powercure-fda-510k.jpg K190272 - Bluephase PowerCure K190272 is a FDA 510(k) cleared dental medical device. Manufacturer: Ivoclar Vivadent, AG. Cleared Jul 2019. https://www.510kdatabase.net/k190442/ 2019-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k190442-koios-ds-for-breast-fda-510k.jpg K190442 - Koios DS for Breast K190442 is a FDA 510(k) cleared radiology medical device. Manufacturer: Koios Medical, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k190589/ 2019-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k190589-cochlear-osia-osi100-implant-cochlear-fda-510k.jpg K190589 - Cochlear Osia OSI100 Implant, Cochlear Osia Sound Processor, Osia Intraoperative Test Software, Osia Fitting Software, Cochlear Osia Surgical Instruments K190589 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Cochlear Americas. Cleared Jul 2019. https://www.510kdatabase.net/k190724/ 2019-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k190724-md-temp-plus-fda-510k.jpg K190724 - MD-Temp Plus K190724 is a FDA 510(k) cleared dental medical device. Manufacturer: Meta Biomed Co., Ltd.. Cleared Jul 2019. https://www.510kdatabase.net/k190915/ 2019-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k190915-osteofab-suture-anchors-fda-510k.jpg K190915 - OsteoFab Suture Anchors K190915 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Oxford Performance Materials, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k190959/ 2019-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k190959-artic-l-3d-ti-spinal-system-with-fda-510k.jpg K190959 - ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology K190959 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k191018/ 2019-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k191018-medline-renewal-reprocessed-masimo-fda-510k.jpg K191018 - Medline ReNewal Reprocessed Masimo LNCS Series Adult and Pediatric SpO2 Adhesive Sensors K191018 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Surgical Instrument Service and Savings, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k191169/ 2019-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k191169-nuvasive-camber-laminoplasty-system-fda-510k.jpg K191169 - NuVasive® Camber Laminoplasty System K191169 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Jul 2019. https://www.510kdatabase.net/k191204/ 2019-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k191204-infinity-fixation-system-fda-510k.jpg K191204 - Infinity Fixation System K191204 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Conmed Corporation. Cleared Jul 2019. https://www.510kdatabase.net/k191451/ 2019-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k191451-cmdr-2cw-multiple-models-fda-510k.jpg K191451 - CMDR 2CW (Multiple models) K191451 is a FDA 510(k) cleared radiology medical device. Manufacturer: Minxray, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k191468/ 2019-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k191468-syngoct-dual-energy-fda-510k.jpg K191468 - syngo.CT Dual Energy K191468 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k191495/ 2019-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k191495-biopsy-positioner-fda-510k.jpg K191495 - Biopsy Positioner K191495 is a FDA 510(k) cleared radiology medical device. Manufacturer: Fujifilm Corporation. Cleared Jul 2019. https://www.510kdatabase.net/k182876/ 2019-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k182876-uro-n-cystoscope-fda-510k.jpg K182876 - Uro-N Cystoscope K182876 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Uroviu Corporation. Cleared Jul 2019. https://www.510kdatabase.net/k183138/ 2019-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k183138-certain-bellatek-express-and-bellatek-fda-510k.jpg K183138 - Certain BellaTek Express and BellaTek Flex Abutments K183138 is a FDA 510(k) cleared dental medical device. Manufacturer: Biomet 3i. Cleared Jul 2019. https://www.510kdatabase.net/k190351/ 2019-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k190351-site-seal-sv-fda-510k.jpg K190351 - Site Seal SV K190351 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ensite Vascular. Cleared Jul 2019. https://www.510kdatabase.net/k190617/ 2019-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k190617-wrap-accessory-electrodes-fda-510k.jpg K190617 - Wrap accessory electrodes K190617 is a FDA 510(k) cleared neurology medical device. Manufacturer: Hi-Dow International, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k190634/ 2019-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k190634-diamondback-360-peripheral-orbital-fda-510k.jpg K190634 - Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System K190634 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cardiovascular Systems, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k190687/ 2019-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k190687-twilite-appliance-fda-510k.jpg K190687 - Twilite Appliance K190687 is a FDA 510(k) cleared dental medical device. Manufacturer: Stephen J Harkins, Dds, PC. Cleared Jul 2019. https://www.510kdatabase.net/k191008/ 2019-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k191008-ilab-polaris-multi-modality-guidance-fda-510k.jpg K191008 - iLab Polaris Multi-Modality Guidance System K191008 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Jul 2019. https://www.510kdatabase.net/k191137/ 2019-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k191137-5mp-color-lcd-monitor-cl-s500-5mp-fda-510k.jpg K191137 - 5MP Color LCD Monitor CL-S500, 5MP Monochrome LCD Monitor MS-S500 K191137 is a FDA 510(k) cleared radiology medical device. Manufacturer: Jvckenwood Corporation. Cleared Jul 2019. https://www.510kdatabase.net/k191460/ 2019-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k191460-pwd-platform-wound-dressing-3-x-5-oblong-fda-510k.jpg K191460 - PWD Platform Wound Dressing 3” x 5” Oblong K191460 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Applied Tissue Technologies, LLC. Cleared Jul 2019. https://www.510kdatabase.net/k182847/ 2019-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k182847-hudson-rci-voldyne-volumetric-exerciser-fda-510k.jpg K182847 - Hudson RCI Voldyne Volumetric Exerciser K182847 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Teleflexmedical, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k183062/ 2019-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k183062-asahi-silverway-fda-510k.jpg K183062 - ASAHI Silverway K183062 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Asahi Intecc Co., Ltd.. Cleared Jul 2019. https://www.510kdatabase.net/k183173/ 2019-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k183173-lightmed-ultrasound-system-fda-510k.jpg K183173 - LIGHTMED Ultrasound System K183173 is a FDA 510(k) cleared radiology medical device. Manufacturer: Lightmed USA, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k190166/ 2019-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k190166-trimed-nitinol-staple-system-fda-510k.jpg K190166 - TriMed Nitinol Staple System K190166 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: TriMed, Inc.. Cleared Jul 2019. https://www.510kdatabase.net/k190524/ 2019-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k190524-mropen-05-t-fda-510k.jpg K190524 - MRopen 0.5 T K190524 is a FDA 510(k) cleared radiology medical device. Manufacturer: Asg Superconductors S.P.A.. Cleared Jul 2019. https://www.510kdatabase.net/k190550/ 2019-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k190550-ikon-40-manual-wheelchair-fda-510k.jpg K190550 - IKON 40 Manual Wheelchair K190550 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Broda Seating (Broda Lp). Cleared Jul 2019. https://www.510kdatabase.net/k190905/ 2019-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k190905-bd-phoenix-automated-microbiology-fda-510k.jpg K190905 - BD Phoenix Automated Microbiology System – GN Ceftaroline (0.0156-4 µg/mL) K190905 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson and Company. Cleared Jul 2019. https://www.510kdatabase.net/k190980/ 2019-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k190980-reprocessed-webster-duo-decapolar-fda-510k.jpg K190980 - Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter K190980 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Innovative Health, LLC. Cleared Jul 2019. https://www.510kdatabase.net/k181672/ 2019-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k181672-suretouch-mobile-pressure-mapping-system-fda-510k.jpg K181672 - SureTouch Mobile Pressure Mapping System K181672 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Sure, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k183021/ 2019-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k183021-clearendoclip-fda-510k.jpg K183021 - ClearEndoclip K183021 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Finemedix Co., Ltd.. Cleared Jun 2019. https://www.510kdatabase.net/k183064/ 2019-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k183064-txti-ibf-system-fda-510k.jpg K183064 - TxTi IBF System K183064 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Innovasis, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k183389/ 2019-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k183389-polyisoprene-powder-free-surgical-fda-510k.jpg K183389 - Polyisoprene Powder Free Surgical Glove, Polyisoprene Powder Free Surgical Underglove K183389 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hartalega NGC Sdn. Bhd.. Cleared Jun 2019. https://www.510kdatabase.net/k190101/ 2019-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k190101-ultraflex-iab-fda-510k.jpg K190101 - UltraFlex IAB K190101 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Arrow International, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k190251/ 2019-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k190251-recoveryrx-fda-510k.jpg K190251 - RecoveryRx K190251 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Bioelectronics Corporation. Cleared Jun 2019. https://www.510kdatabase.net/k190341/ 2019-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k190341-ic-gn-ic-cassette-for-use-on-the-ic-fda-510k.jpg K190341 - iC-GN iC-Cassette for use on the iC-System K190341 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Icubate, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k190475/ 2019-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k190475-delivery-catheter-sspc1-delivery-fda-510k.jpg K190475 - Delivery Catheter SSPC1, Delivery Catheter SSPC2, Delivery Catheter SSPC3, Delivery Catheter SSPC4 K190475 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Centerpoint Systems. Cleared Jun 2019. https://www.510kdatabase.net/k190516/ 2019-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k190516-microlink-all-suture-button-fixation-fda-510k.jpg K190516 - MicroLink All-Suture Button Fixation System (Radiolucent) K190516 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Conmed Corporation. Cleared Jun 2019. https://www.510kdatabase.net/k190582/ 2019-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k190582-microlink-all-suture-button-fixation-fda-510k.jpg K190582 - MicroLink All-Suture Button Fixation System (Radiopaque) K190582 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Conmed Corporation. Cleared Jun 2019. https://www.510kdatabase.net/k190654/ 2019-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k190654-straumann-ci-rd-ceramic-healing-caps-fda-510k.jpg K190654 - Straumann CI RD Ceramic Healing Caps K190654 is a FDA 510(k) cleared dental medical device. Manufacturer: Institut Straumann AG. Cleared Jun 2019. https://www.510kdatabase.net/k190696/ 2019-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k190696-stryker-surgeon-id-mandible-recon-plate-fda-510k.jpg K190696 - Stryker Surgeon iD Mandible Recon Plate K190696 is a FDA 510(k) cleared dental medical device. Manufacturer: Stryker. Cleared Jun 2019. https://www.510kdatabase.net/k191223/ 2019-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k191223-navio-fda-510k.jpg K191223 - NAVIO K191223 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Blue Belt Technologies, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k191450/ 2019-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k191450-dexcom-g6-continuous-glucose-fda-510k.jpg K191450 - Dexcom G6 Continuous Glucose Monitoring System, Dexcom G6 Glucose Program Continuous Glucose Monitoring System and Dexcom Pro Q Continuous Glucose Monitoring System K191450 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dexcom, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k191483/ 2019-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k191483-healix-advance-anchor-with-dynatape-fda-510k.jpg K191483 - HEALIX ADVANCE Anchor with DYNA+TAPE Sutures K191483 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International SARL. Cleared Jun 2019. https://www.510kdatabase.net/k182683/ 2019-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k182683-z-robot-patient-positioning-system-fda-510k.jpg K182683 - Z-Robot Patient Positioning System K182683 is a FDA 510(k) cleared radiology medical device. Manufacturer: Chinan Biomedical Technology, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k182733/ 2019-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k182733-rochal-bioshield-silicone-film-fda-510k.jpg K182733 - Rochal Bioshield Silicone Film K182733 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Rochal Industries, LLC. Cleared Jun 2019. https://www.510kdatabase.net/k183183/ 2019-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k183183-vicryl-polyglactin-910-sterile-fda-510k.jpg K183183 - VICRYL Polyglactin 910 Sterile Synthetic Absorbable Surgical Suture, PDS II Polydioxanone Sterile Synthetic Absorbable Surgical Suture, PDS Plus Antibacterial Polydioxanone Sterile Synthetic Absorbable Surgical Suture K183183 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k183602/ 2019-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k183602-swimcount-sperm-quality-test-fda-510k.jpg K183602 - SwimCount Sperm Quality Test K183602 is a FDA 510(k) cleared hematology medical device. Manufacturer: Motilitycount Aps. Cleared Jun 2019. https://www.510kdatabase.net/k190017/ 2019-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k190017-livermultiscan-lmsv3-fda-510k.jpg K190017 - LiverMultiScan (LMSv3) K190017 is a FDA 510(k) cleared radiology medical device. Manufacturer: Perspectum Diagnostics, Ltd.. Cleared Jun 2019. https://www.510kdatabase.net/k190080/ 2019-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k190080-powder-free-nitrile-examination-gloves-fda-510k.jpg K190080 - Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs Labeling Claim (Black) K190080 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Comfort Rubber Gloves Industries Sdn. Bhd.. Cleared Jun 2019. https://www.510kdatabase.net/k190578/ 2019-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k190578-somatom-force-somatom-definition-flash-fda-510k.jpg K190578 - SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Edge Plus, SOMATOM Definition AS/AS+, SOMATOM Confidence K190578 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k190583/ 2019-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k190583-dynaflex-fda-510k.jpg K190583 - DynaFlex K190583 is a FDA 510(k) cleared dental medical device. Manufacturer: Dyna Flex. Cleared Jun 2019. https://www.510kdatabase.net/k190782/ 2019-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k190782-flexgard-cut-resistant-glove-liners-fda-510k.jpg K190782 - FlexGard Cut-Resistant Glove Liners K190782 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ldi Corporation. Cleared Jun 2019. https://www.510kdatabase.net/k191175/ 2019-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k191175-acist-kodama-intravascular-ultrasound-fda-510k.jpg K191175 - ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi System K191175 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Acist Medical Systems, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k191438/ 2019-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k191438-erbeflo-2-endo-quick-connect-pentax-fda-510k.jpg K191438 - ERBEFLO 2 Endo Quick Connect Pentax Scope Port Connector K191438 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Erbe USA, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k191465/ 2019-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k191465-human-igm-kit-for-use-on-spaplus-fda-510k.jpg K191465 - Human IgM Kit for use on SPAPlus K191465 is a FDA 510(k) cleared immunology medical device. Manufacturer: The Binding Site Group , Ltd.. Cleared Jun 2019. https://www.510kdatabase.net/k182832/ 2019-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k182832-cope-pediatric-gastrointestinal-suture-fda-510k.jpg K182832 - Cope Pediatric Gastrointestinal Suture Anchor Set, Enterostomy Suture Anchor Set K182832 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Jun 2019. https://www.510kdatabase.net/k182851/ 2019-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k182851-skybreeze-zero-nitrile-powder-free-fda-510k.jpg K182851 - SkyBreeze Zero Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs K182851 is a FDA 510(k) cleared general hospital medical device. Manufacturer: O&M Halyard, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k190096/ 2019-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k190096-r2gate-fda-510k.jpg K190096 - R2GATE K190096 is a FDA 510(k) cleared radiology medical device. Manufacturer: Megagen Implant Co., Ltd.. Cleared Jun 2019. https://www.510kdatabase.net/k190097/ 2019-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k190097-straumann-cares-screw-retained-bridges-fda-510k.jpg K190097 - Straumann CARES Screw-Retained Bridges and Bars K190097 is a FDA 510(k) cleared dental medical device. Manufacturer: Institut Straumann AG. Cleared Jun 2019. https://www.510kdatabase.net/k190299/ 2019-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k190299-elos-accurate-customized-abutment-fda-510k.jpg K190299 - Elos Accurate® Customized Abutment K190299 is a FDA 510(k) cleared dental medical device. Manufacturer: Elos Medtech Pinol A/S. Cleared Jun 2019. https://www.510kdatabase.net/k190938/ 2019-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k190938-phototherapy-system-fda-510k.jpg K190938 - Phototherapy System K190938 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shanghai Apolo Medical Technology Co., Ltd.. Cleared Jun 2019. https://www.510kdatabase.net/k191128/ 2019-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k191128-vantage-titan-3t-mrt-3010-v25-fda-510k.jpg K191128 - Vantage Titan 3T, MRT-3010, V2.5 K191128 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Jun 2019. https://www.510kdatabase.net/k191166/ 2019-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k191166-dignicap-delta-fda-510k.jpg K191166 - DigniCap Delta K191166 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Dignitana, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k191485/ 2019-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k191485-deflectable-brush-biopsy-set-fda-510k.jpg K191485 - Deflectable Brush Biopsy Set K191485 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Jun 2019. https://www.510kdatabase.net/k182704/ 2019-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k182704-wishbone-guided-growth-system-fda-510k.jpg K182704 - WishBone Guided Growth System K182704 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wishbone Medical. Cleared Jun 2019. https://www.510kdatabase.net/k190052/ 2019-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k190052-radio-frequency-ablation-system-fda-510k.jpg K190052 - Radio Frequency Ablation System K190052 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.. Cleared Jun 2019. https://www.510kdatabase.net/k190743/ 2019-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k190743-venus-bliss-fda-510k.jpg K190743 - Venus Bliss K190743 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Venus Concept USA, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k190779/ 2019-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k190779-trevo-xp-provue-retriever-fda-510k.jpg K190779 - Trevo XP ProVue Retriever K190779 is a FDA 510(k) cleared neurology medical device. Manufacturer: Stryker. Cleared Jun 2019. https://www.510kdatabase.net/k190784/ 2019-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k190784-buhlmann-fcal-turbo-fda-510k.jpg K190784 - BUHLMANN fCAL turbo K190784 is a FDA 510(k) cleared immunology medical device. Manufacturer: Buhlmann Laboratories AG. Cleared Jun 2019. https://www.510kdatabase.net/k190785/ 2019-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k190785-reprocessed-pentaray-nav-eco-high-fda-510k.jpg K190785 - Reprocessed PentaRay Nav eco High-Density Mapping Catheter K190785 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Innovative Health, LLC. Cleared Jun 2019. https://www.510kdatabase.net/k191168/ 2019-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k191168-cepheid-xpert-sa-nasal-complete-fda-510k.jpg K191168 - Cepheid Xpert SA Nasal Complete Control Panel K191168 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Microbiologics, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k191194/ 2019-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k191194-clarus-fda-510k.jpg K191194 - CLARUS K191194 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Carl Zeiss Meditec, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k191207/ 2019-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k191207-guardian-angel-rx-ga2001-digital-vital-fda-510k.jpg K191207 - Guardian Angel Rx GA2001 Digital Vital Sign Monitoring System K191207 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Taiwan Aulisa Medical Devices Technologies, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k171304/ 2019-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k171304-maxxi-rip-sensor-fda-510k.jpg K171304 - Maxxi Rip Sensor K171304 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Neurovirtual USA, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k182411/ 2019-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k182411-scooter-model-r-100-fda-510k.jpg K182411 - Scooter, Model: R-100 K182411 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Yongkang Dingchang Industry & Trade Co., Ltd.. Cleared Jun 2019. https://www.510kdatabase.net/k183032/ 2019-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k183032-fujifilm-double-balloon-endoscope-fda-510k.jpg K183032 - FUJIFILM Double Balloon Endoscope EI580BT K183032 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fujifilm Corporation. Cleared Jun 2019. https://www.510kdatabase.net/k183170/ 2019-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k183170-uws-ct-fda-510k.jpg K183170 - uWS-CT K183170 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Jun 2019. https://www.510kdatabase.net/k190106/ 2019-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k190106-intra-operative-positioning-system-fda-510k.jpg K190106 - Intra-Operative Positioning System K190106 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Centerline Biomedical, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k190443/ 2019-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k190443-mmsphere-fda-510k.jpg K190443 - MMSphere K190443 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Galactic Beauty, LLC. Cleared Jun 2019. https://www.510kdatabase.net/k190927/ 2019-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k190927-oscillometric-blood-pressure-monitor-fda-510k.jpg K190927 - Oscillometric Blood Pressure Monitor K190927 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Rudolf Riester GmbH. Cleared Jun 2019. https://www.510kdatabase.net/k190754/ 2019-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k190754-orthossr-fda-510k.jpg K190754 - Orthoss(R) K190754 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Geistlich Pharma AG. Cleared Jun 2019. https://www.510kdatabase.net/k182844/ 2019-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k182844-asahi-sasuke-fda-510k.jpg K182844 - ASAHI SASUKE K182844 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Asahi Intecc Co., Ltd.. Cleared Jun 2019. https://www.510kdatabase.net/k181260/ 2019-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k181260-miis-horus-scope-dpt-100-fda-510k.jpg K181260 - MiiS Horus Scope DPT 100 K181260 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Medimaging Integrated Solution, Inc (Miis). Cleared Jun 2019. https://www.510kdatabase.net/k182139/ 2019-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k182139-axti-titanium-stand-alone-alif-system-fda-510k.jpg K182139 - AXTi Titanium Stand-Alone ALIF System K182139 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Innovasis, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k182960/ 2019-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k182960-reliefband-fda-510k.jpg K182960 - ReliefBand K182960 is a FDA 510(k) cleared neurology medical device. Manufacturer: Reliefband Technologies, LLC. Cleared Jun 2019. https://www.510kdatabase.net/k182963/ 2019-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k182963-emfieldpro-fda-510k.jpg K182963 - emFieldPro K182963 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zimmer Medizinsysteme GmbH. Cleared Jun 2019. https://www.510kdatabase.net/k183220/ 2019-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k183220-orthoscan-tau-mini-c-arm-fda-510k.jpg K183220 - OrthoScan TAU Mini C-Arm K183220 is a FDA 510(k) cleared radiology medical device. Manufacturer: Orthoscan, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k183262/ 2019-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k183262-esocheck-ccd-cell-collection-device-fda-510k.jpg K183262 - EsoCheck CCD Cell Collection Device K183262 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Lucid Diagnostics, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k183595/ 2019-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k183595-aqua-medical-rf-vapor-system-fda-510k.jpg K183595 - Aqua Medical RF Vapor System K183595 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Aqua Medical, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k190130/ 2019-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k190130-the-clearsight-finger-cuffs-fda-510k.jpg K190130 - The ClearSight finger cuffs K190130 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Jun 2019. https://www.510kdatabase.net/k190152/ 2019-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k190152-vit-kit-freeze-nx-and-vit-kit-warm-nx-fda-510k.jpg K190152 - Vit Kit- Freeze NX and Vit Kit- Warm NX K190152 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Fujifilm Irvine Scientific, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k190360/ 2019-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k190360-linesider-spinal-system-fda-510k.jpg K190360 - LineSider™ Spinal System K190360 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Integrity Implants, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k190597/ 2019-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k190597-brilliant-everglow-flow-fda-510k.jpg K190597 - BRILLIANT EverGlow Flow K190597 is a FDA 510(k) cleared dental medical device. Manufacturer: Coltene/Whaledent AG. Cleared Jun 2019. https://www.510kdatabase.net/k190750/ 2019-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k190750-depuy-synthes-plates-and-screws-fda-510k.jpg K190750 - DePuy Synthes Plates and Screws Portfolio K190750 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Synthes. Cleared Jun 2019. https://www.510kdatabase.net/k191151/ 2019-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k191151-jkh-stimulator-plus-fda-510k.jpg K191151 - JKH Stimulator Plus K191151 is a FDA 510(k) cleared neurology medical device. Manufacturer: Jkh USA, LLC. Cleared Jun 2019. https://www.510kdatabase.net/k191388/ 2019-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k191388-flopatch-fp110-fda-510k.jpg K191388 - FloPatch (FP110) K191388 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Flosonics Medical (R/A 1929803 Ontario Corp.). Cleared Jun 2019. https://www.510kdatabase.net/k191400/ 2019-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k191400-voyager-trajectory-array-guide-v-tag-fda-510k.jpg K191400 - Voyager Trajectory Array Guide (V-TAG) K191400 is a FDA 510(k) cleared neurology medical device. Manufacturer: Mri Interventions, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k182285/ 2019-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k182285-pk-high-tibial-osteotomy-correction-fda-510k.jpg K182285 - PK High Tibial Osteotomy Correction System K182285 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paonan Biotech Co., Ltd.. Cleared Jun 2019. https://www.510kdatabase.net/k182742/ 2019-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k182742-db-cmf-fda-510k.jpg K182742 - DB-CMF K182742 is a FDA 510(k) cleared neurology medical device. Manufacturer: Dimensional Bioceramics, LLC. Cleared Jun 2019. https://www.510kdatabase.net/k183354/ 2019-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k183354-powder-free-blue-nitrile-examination-fda-510k.jpg K183354 - Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl Citrate K183354 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Gx Corporation Sdn Bhd. Cleared Jun 2019. https://www.510kdatabase.net/k183450/ 2019-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k183450-embody-system-fda-510k.jpg K183450 - EmBody System K183450 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Inmode MD , Ltd.. Cleared Jun 2019. https://www.510kdatabase.net/k183580/ 2019-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k183580-panthera-dental-milled-bars-fda-510k.jpg K183580 - Panthera Dental Milled Bars K183580 is a FDA 510(k) cleared dental medical device. Manufacturer: Panthera Dental, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k183624/ 2019-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k183624-kubtec-mozart-xpert42-fda-510k.jpg K183624 - Kubtec Mozart (Xpert42) K183624 is a FDA 510(k) cleared radiology medical device. Manufacturer: Kub Technologies, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k190095/ 2019-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k190095-powder-free-clear-vinyl-patient-fda-510k.jpg K190095 - Powder-Free Clear Vinyl Patient Examination Gloves K190095 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Anhui Intco Medical Products Co., Ltd.. Cleared Jun 2019. https://www.510kdatabase.net/k190122/ 2019-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k190122-renovis-a200-ps-knee-system-as-part-of-fda-510k.jpg K190122 - Renovis A200 PS Knee System as part of the Renovis A200 Knee System K190122 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Renovis Surgical Technologies. Cleared Jun 2019. https://www.510kdatabase.net/k190336/ 2019-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k190336-soniquence-bipolar-electrodes-fda-510k.jpg K190336 - Soniquence Bipolar Electrodes K190336 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Soniquence, LLC. Cleared Jun 2019. https://www.510kdatabase.net/k190545/ 2019-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k190545-vader-one-pedicle-system-mis-and-fda-510k.jpg K190545 - VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 K190545 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Icotec AG. Cleared Jun 2019. https://www.510kdatabase.net/k191172/ 2019-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k191172-cepheid-xpert-mrsa-nxg-control-panel-fda-510k.jpg K191172 - Cepheid Xpert MRSA NxG Control Panel K191172 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Microbiologics, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k191442/ 2019-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k191442-campylobacter-chek-fda-510k.jpg K191442 - Campylobacter Chek K191442 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Techlab, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k191456/ 2019-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k191456-campylobacter-quik-chek-fda-510k.jpg K191456 - Campylobacter Quik Chek K191456 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Techlab, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k182638/ 2019-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k182638-hailie-sensor-fda-510k.jpg K182638 - Hailie Sensor K182638 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Adherium (Nz), Ltd.. Cleared Jun 2019. https://www.510kdatabase.net/k182658/ 2019-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k182658-bioliner-fda-510k.jpg K182658 - Bioliner K182658 is a FDA 510(k) cleared dental medical device. Manufacturer: Five Star Orthodontic Lab & Supply. Cleared Jun 2019. https://www.510kdatabase.net/k182703/ 2019-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k182703-entericbio-dx-assay-fda-510k.jpg K182703 - EntericBio Dx Assay K182703 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Serosep , Ltd.. Cleared Jun 2019. https://www.510kdatabase.net/k182719/ 2019-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k182719-quidel-triage-tox-drug-screen-94600-fda-510k.jpg K182719 - Quidel Triage TOX Drug Screen, 94600 K182719 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Quidel Cardiovascular, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k182774/ 2019-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k182774-stop-u-packed-black-usa-stop-u-packed-fda-510k.jpg K182774 - STOP U (Packed Black USA), STOP U (Packed White USA) K182774 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Pollogen, Ltd.. Cleared Jun 2019. https://www.510kdatabase.net/k182785/ 2019-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k182785-loqteq-va-foot-plates-25-fda-510k.jpg K182785 - LOQTEQ VA Foot Plates 2.5 K182785 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aap Implantate AG. Cleared Jun 2019. https://www.510kdatabase.net/k190115/ 2019-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k190115-mhd-tens-fda-510k.jpg K190115 - MHD TENS K190115 is a FDA 510(k) cleared neurology medical device. Manufacturer: Minghuangda Electronic Co., Ltd.. Cleared Jun 2019. https://www.510kdatabase.net/k190387/ 2019-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k190387-raystation-fda-510k.jpg K190387 - RayStation K190387 is a FDA 510(k) cleared radiology medical device. Manufacturer: RaySearch Laboratories AB (PUBL). Cleared Jun 2019. https://www.510kdatabase.net/k190762/ 2019-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k190762-the-jasper-spinal-fixation-system-ii-fda-510k.jpg K190762 - The JASPER Spinal Fixation System II K190762 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Gbs Commonwealth Co., Ltd.. Cleared Jun 2019. https://www.510kdatabase.net/k190889/ 2019-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k190889-republic-spine-restore-cervical-fda-510k.jpg K190889 - Republic Spine Restore Cervical Interbody Fusion System K190889 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Republic Spine, LLC. Cleared Jun 2019. https://www.510kdatabase.net/k191418/ 2019-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k191418-multix-fusion-max-fda-510k.jpg K191418 - Multix Fusion Max K191418 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k182493/ 2019-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k182493-bovine-pericardial-tissue-patch-fda-510k.jpg K182493 - Bovine Pericardial Tissue Patch K182493 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Tisgenx. Cleared Jun 2019. https://www.510kdatabase.net/k182667/ 2019-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k182667-med-link-temperature-probes-fda-510k.jpg K182667 - Med-link Temperature Probes K182667 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen Med-Link Electronics Tech Co., Ltd.. Cleared Jun 2019. https://www.510kdatabase.net/k183385/ 2019-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k183385-nanoknife-system-fda-510k.jpg K183385 - NanoKnife System K183385 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Angiodynamics. Cleared Jun 2019. https://www.510kdatabase.net/k183578/ 2019-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k183578-torpedo-gelatin-foam-fda-510k.jpg K183578 - Torpedo Gelatin Foam K183578 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biosphere Medical, S.A.. Cleared Jun 2019. https://www.510kdatabase.net/k190913/ 2019-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k190913-qlab-advanced-quantification-software-13-fda-510k.jpg K190913 - QLAB Advanced Quantification Software 13 K190913 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Health Care. Cleared Jun 2019. https://www.510kdatabase.net/k191049/ 2019-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k191049-stryker-mis-and-footed-attachments-fda-510k.jpg K191049 - Stryker MIS and Footed Attachments K191049 is a FDA 510(k) cleared neurology medical device. Manufacturer: Stryker Corporation. Cleared Jun 2019. https://www.510kdatabase.net/k191209/ 2019-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k191209-aneroid-type-blood-pressure-kit-fda-510k.jpg K191209 - Aneroid Type Blood Pressure Kit K191209 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Dongguan Mars Medical Products Co., Ltd.. Cleared Jun 2019. https://www.510kdatabase.net/k182524/ 2019-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k182524-galileo-spine-alignment-monitoring-fda-510k.jpg K182524 - GALILEO Spine Alignment Monitoring System K182524 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: MiRus, LLC. Cleared Jun 2019. https://www.510kdatabase.net/k182695/ 2019-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k182695-pigtail-ureteral-catheter-set-sof-flex-fda-510k.jpg K182695 - Pigtail Ureteral Catheter Set, Sof-Flex AQ Coated Pigtail Ureteral Catheter K182695 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Jun 2019. https://www.510kdatabase.net/k190121/ 2019-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k190121-ids-shbg-fda-510k.jpg K190121 - IDS SHBG K190121 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Immunodiagnostic Systems , Ltd.. Cleared Jun 2019. https://www.510kdatabase.net/k190662/ 2019-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k190662-mri-compatibility-for-existing-fda-510k.jpg K190662 - MRI Compatibility for Existing Straumann Dental Implant Systems K190662 is a FDA 510(k) cleared dental medical device. Manufacturer: Straumann USA, LLC. Cleared Jun 2019. https://www.510kdatabase.net/k190663/ 2019-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k190663-epidural-minifilter-luer-80369-7-fda-510k.jpg K190663 - Epidural MiniFilter LUER 80369-7, Epidural MiniFilter NRFit 80369-6 K190663 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: PAJUNK GmbH Medizintechnologie. Cleared Jun 2019. https://www.510kdatabase.net/k190684/ 2019-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k190684-lxha-peek-lateral-ibf-system-fda-510k.jpg K190684 - LxHA PEEK Lateral IBF System K190684 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Innovasis, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k190936/ 2019-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k190936-q-switched-nd-yag-laser-system-fda-510k.jpg K190936 - Q-Switched Nd: YAG Laser System K190936 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shanghai Apolo Medical Technology Co., Ltd.. Cleared Jun 2019. https://www.510kdatabase.net/k191368/ 2019-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k191368-flowtriever-retrievalaspiration-system-fda-510k.jpg K191368 - FlowTriever Retrieval/Aspiration System K191368 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inari Medical. Cleared Jun 2019. https://www.510kdatabase.net/k190010/ 2019-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k190010-penumbra-system-reperfusion-catheter-fda-510k.jpg K190010 - Penumbra System Reperfusion Catheter JET 7 K190010 is a FDA 510(k) cleared neurology medical device. Manufacturer: Penumbra, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k183195/ 2019-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k183195-vivo-fda-510k.jpg K183195 - VIVO K183195 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Catheter Precision, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k183219/ 2019-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k183219-trio-ct-triple-lumen-catheter-fda-510k.jpg K183219 - Trio-CT Triple Lumen Catheter K183219 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medical Components, Inc. (dba MedComp). Cleared Jun 2019. https://www.510kdatabase.net/k183263/ 2019-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k183263-unipack-barrier-sleeve-and-barrier-fda-510k.jpg K183263 - UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope K183263 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Unipack Medical Corporation. Cleared Jun 2019. https://www.510kdatabase.net/k183431/ 2019-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k183431-medline-digital-rectal-thermometer-fda-510k.jpg K183431 - Medline Digital Rectal Thermometer Sheath K183431 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k183566/ 2019-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k183566-clarity-ii-laser-system-fda-510k.jpg K183566 - CLARITY II Laser System K183566 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lutronic Corporation. Cleared Jun 2019. https://www.510kdatabase.net/k190172/ 2019-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k190172-stryker-elite-attachments-stryker-fda-510k.jpg K190172 - Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments K190172 is a FDA 510(k) cleared neurology medical device. Manufacturer: Stryker. Cleared Jun 2019. https://www.510kdatabase.net/k190414/ 2019-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k190414-moss-gastrostomy-tube-moss-nasal-tube-fda-510k.jpg K190414 - Moss Gastrostomy Tube, Moss Nasal Tube – Mark IV K190414 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Moss Tubes, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k190700/ 2019-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k190700-electrodes-pad-fda-510k.jpg K190700 - ELECTRODES PAD K190700 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Bestpad Technology Development Co., Ltd.. Cleared Jun 2019. https://www.510kdatabase.net/k191299/ 2019-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k191299-silhouette-featherlift-silhouette-lift-fda-510k.jpg K191299 - Silhouette Featherlift / Silhouette Lift K191299 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Silhouette Lift, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k191318/ 2019-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k191318-aequalis-flex-revive-shoulder-system-fda-510k.jpg K191318 - AEQUALIS FLEX REVIVE Shoulder System K191318 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tornier, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k191387/ 2019-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k191387-envizion-medical-envue-system-envizion-fda-510k.jpg K191387 - ENvizion Medical ENVue SYSTEM, ENvizion Medical Enteral Feeding Tube K191387 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Envizion Medical , Ltd.. Cleared Jun 2019. https://www.510kdatabase.net/k181514/ 2019-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k181514-seraquest-hsv-type-2-specific-igg-fda-510k.jpg K181514 - SeraQuest HSV Type 2 Specific IgG K181514 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Quest International, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k181965/ 2019-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k181965-restore-toothpaste-fda-510k.jpg K181965 - Restore Toothpaste K181965 is a FDA 510(k) cleared dental medical device. Manufacturer: Dr. Collins, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k182159/ 2019-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k182159-strome-blitzer-cytology-balloon-fda-510k.jpg K182159 - Strome-Blitzer Cytology Balloon K182159 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Adn International, LLC. Cleared Jun 2019. https://www.510kdatabase.net/k182608/ 2019-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k182608-oyster-acif-cage-fda-510k.jpg K182608 - Oyster ACIF Cage K182608 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Silony Medical GmbH. Cleared Jun 2019. https://www.510kdatabase.net/k183363/ 2019-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k183363-treace-medical-concepts-tmc-snap-off-fda-510k.jpg K183363 - Treace Medical Concepts (TMC) Snap-Off Screw System K183363 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Treace Medical Concepts, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k183460/ 2019-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k183460-clarictai-fda-510k.jpg K183460 - ClariCT.AI K183460 is a FDA 510(k) cleared radiology medical device. Manufacturer: Claripi, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k183513/ 2019-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k183513-xenosure-dura-biologic-patch-fda-510k.jpg K183513 - XenoSure Dura Biologic Patch K183513 is a FDA 510(k) cleared neurology medical device. Manufacturer: LeMaitre Vascular, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k183564/ 2019-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k183564-electrosurgical-generator-fda-510k.jpg K183564 - Electrosurgical Generator K183564 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Fulwell, LLC. Cleared Jun 2019. https://www.510kdatabase.net/k190117/ 2019-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k190117-fiberoptix-iab-fda-510k.jpg K190117 - Fiberoptix IAB K190117 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Arrow International, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k190133/ 2019-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k190133-full-automatic-nibp-blood-pressure-fda-510k.jpg K190133 - Full Automatic (NIBP) Blood Pressure Monitor-HL158UB K190133 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Health & Life Co., Ltd.. Cleared Jun 2019. https://www.510kdatabase.net/k190228/ 2019-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k190228-transcranial-doppler-ultrasound-system-fda-510k.jpg K190228 - Transcranial Doppler Ultrasound System K190228 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Delica Medical Equipment Co., Ltd.. Cleared Jun 2019. https://www.510kdatabase.net/k190424/ 2019-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k190424-healthich-fda-510k.jpg K190424 - HealthICH K190424 is a FDA 510(k) cleared radiology medical device. Manufacturer: Zebra Medical Vision, Ltd.. Cleared Jun 2019. https://www.510kdatabase.net/k190667/ 2019-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k190667-sonopet-iq-sterilization-tray-fda-510k.jpg K190667 - Sonopet iQ Sterilization Tray K190667 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Paragon Medical. Cleared Jun 2019. https://www.510kdatabase.net/k191005/ 2019-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k191005-prolift-expandable-system-fda-510k.jpg K191005 - ProLift® Expandable System K191005 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k191036/ 2019-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k191036-symri-fda-510k.jpg K191036 - SyMRI K191036 is a FDA 510(k) cleared radiology medical device. Manufacturer: Syntheticmr AB. Cleared Jun 2019. https://www.510kdatabase.net/k191089/ 2019-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k191089-edwards-pressure-cable-fda-510k.jpg K191089 - Edwards Pressure Cable K191089 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Jun 2019. https://www.510kdatabase.net/k191341/ 2019-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k191341-veloxion-controller-kit-veloxion-fluid-fda-510k.jpg K191341 - Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags K191341 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Corinth Medtech, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k172232/ 2019-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k172232-liasys-600-electrolyte-measurement-fda-510k.jpg K172232 - LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600 K172232 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Ams Diagnostics. Cleared Jun 2019. https://www.510kdatabase.net/k180511/ 2019-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k180511-eon-fr-fda-510k.jpg K180511 - Eon FR K180511 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Dominion Aesthetic Technologies, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k182749/ 2019-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k182749-lansinoh-signature-pro-double-electric-fda-510k.jpg K182749 - Lansinoh Signature Pro Double Electric Breast Pump, Lansinoh Smartpump Double Electric Breast Pump K182749 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Lansinoh Laboratories Saglik Gerecleri Tasarim San. Tic., Ltd.. Cleared Jun 2019. https://www.510kdatabase.net/k183046/ 2019-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k183046-aquilion-one-tsx-305a6-v89-with-aice-fda-510k.jpg K183046 - Aquilion ONE (TSX-305A/6) V8.9 with AiCE K183046 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Jun 2019. https://www.510kdatabase.net/k183335/ 2019-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k183335-medline-poly-cath-red-polymer-urethral-fda-510k.jpg K183335 - Medline Poly-Cath Red Polymer Urethral Catheter K183335 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medline Industries, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k183691/ 2019-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k183691-pentax-medical-ent-video-imaging-system-fda-510k.jpg K183691 - PENTAX Medical ENT Video Imaging System K183691 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Pentax of America, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k183692/ 2019-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k183692-avid-if2-fda-510k.jpg K183692 - Avid IF2 K183692 is a FDA 510(k) cleared neurology medical device. Manufacturer: Vision Quest Industries Inc./Dba VQ Orthocare. Cleared Jun 2019. https://www.510kdatabase.net/k190016/ 2019-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k190016-lateral-plate-system-fda-510k.jpg K190016 - Lateral Plate System K190016 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corelink, LLC. Cleared Jun 2019. https://www.510kdatabase.net/k190177/ 2019-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k190177-j-type-marrow-biopsy-needlet-type-fda-510k.jpg K190177 - J-Type Marrow Biopsy Needle,T-Type Marrow Biopsy Needle,Tweezer Bone Marrow Biopsy Needle, K190177 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ranfac Corporation. Cleared Jun 2019. https://www.510kdatabase.net/k190185/ 2019-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k190185-phasix-st-mesh-with-open-positioning-fda-510k.jpg K190185 - Phasix ST Mesh with Open Positioning System K190185 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k190422/ 2019-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k190422-viveve-system-20-fda-510k.jpg K190422 - Viveve System 2.0 K190422 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Viveve Medical. Cleared Jun 2019. https://www.510kdatabase.net/k190521/ 2019-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k190521-aequalis-ascend-flex-shoulder-system-fda-510k.jpg K190521 - Aequalis Ascend Flex Shoulder System K190521 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tornier S.A.S.. Cleared Jun 2019. https://www.510kdatabase.net/k191038/ 2019-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k191038-on-call-express-voice-blood-glucose-fda-510k.jpg K191038 - On Call Express Voice Blood Glucose Monitoring System K191038 is a FDA 510(k) cleared chemistry medical device. Manufacturer: ACON Laboratories, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k191055/ 2019-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k191055-hs40-diagnostic-ultrasound-system-fda-510k.jpg K191055 - HS40 Diagnostic Ultrasound System K191055 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Medison Co., Ltd.. Cleared Jun 2019. https://www.510kdatabase.net/k191064/ 2019-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k191064-argon-handset-fda-510k.jpg K191064 - Argon Handset K191064 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: New Deantronics Taiwan , Ltd.. Cleared Jun 2019. https://www.510kdatabase.net/k191115/ 2019-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k191115-rs85-diagnostic-ultrasound-system-fda-510k.jpg K191115 - RS85 Diagnostic Ultrasound System K191115 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Medison Co., Ltd.. Cleared Jun 2019. https://www.510kdatabase.net/k191291/ 2019-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k191291-wallace-dual-lumen-oocyte-recovery-fda-510k.jpg K191291 - Wallace Dual Lumen Oocyte Recovery System K191291 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: CooperSurgical, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k191331/ 2019-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k191331-life-sensor-cardiac-monitor-fda-510k.jpg K191331 - Life Sensor Cardiac Monitor K191331 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Braveheart Wireless, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k182416/ 2019-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k182416-nova-minimally-invasive-system-fda-510k.jpg K182416 - NOVA Minimally Invasive System K182416 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Baui Biotech Co., Ltd.. Cleared Jun 2019. https://www.510kdatabase.net/k182656/ 2019-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k182656-jambro-single-core-a-sterilization-wrap-fda-510k.jpg K182656 - JAMBRO Single Core A Sterilization wrap K182656 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Zhande Medical Supplies Co., Ltd.. Cleared Jun 2019. https://www.510kdatabase.net/k182713/ 2019-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k182713-scoreflex-pta-scoring-balloon-catheter-fda-510k.jpg K182713 - Scoreflex PTA Scoring Balloon Catheter K182713 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Orbusneich Medical Trading, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k191226/ 2019-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k191226-arthrex-swivelock-suture-anchor-fda-510k.jpg K191226 - Arthrex SwiveLock Suture Anchor K191226 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k191268/ 2019-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k191268-force-fiber-suture-fda-510k.jpg K191268 - Force Fiber Suture K191268 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Teleflex Medical Incorporated. Cleared Jun 2019. https://www.510kdatabase.net/k191271/ 2019-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k191271-t2-alpha-femur-antegrade-gtpf-nailing-fda-510k.jpg K191271 - T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Alpha Tibia Nailing System, IMN Screws System, IMN Instruments System K191271 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Trauma GmbH. Cleared Jun 2019. https://www.510kdatabase.net/k191285/ 2019-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k191285-spine-trauma-navigation-fda-510k.jpg K191285 - Spine & Trauma Navigation K191285 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Brainlab AG. Cleared Jun 2019. https://www.510kdatabase.net/k182650/ 2019-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k182650-arzzt-distal-radius-and-ulna-system-fda-510k.jpg K182650 - Arzzt Distal Radius and Ulna System K182650 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Truemed Group, LLC. Cleared Jun 2019. https://www.510kdatabase.net/k183104/ 2019-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k183104-mini-cannulated-headed-and-headless-fda-510k.jpg K183104 - Mini Cannulated Headed and Headless Screw Set K183104 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker GmbH. Cleared Jun 2019. https://www.510kdatabase.net/k183630/ 2019-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k183630-spineart-navigation-instrument-system-fda-510k.jpg K183630 - SPINEART Navigation Instrument System K183630 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spineart SA. Cleared Jun 2019. https://www.510kdatabase.net/k190220/ 2019-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k190220-vista-fs-vista-fs-liquid-fda-510k.jpg K190220 - Vista FS, Vista FS Liquid K190220 is a FDA 510(k) cleared dental medical device. Manufacturer: Inter-Med/Vista Dental Products. Cleared Jun 2019. https://www.510kdatabase.net/k190814/ 2019-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k190814-accufill-bone-substitute-material-fda-510k.jpg K190814 - AccuFill Bone Substitute Material K190814 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer Knee Creations. Cleared Jun 2019. https://www.510kdatabase.net/k191072/ 2019-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k191072-7410-ultrasound-system-mylabsigma-fda-510k.jpg K191072 - 7410 Ultrasound System (MyLabSigma) K191072 is a FDA 510(k) cleared radiology medical device. Manufacturer: Esaote, S.P.A.. Cleared Jun 2019. https://www.510kdatabase.net/k191310/ 2019-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k191310-insight-essentials-drf-digital-imaging-fda-510k.jpg K191310 - Insight Essentials DRF Digital Imaging System K191310 is a FDA 510(k) cleared radiology medical device. Manufacturer: Imaging Engineering, LLC. Cleared Jun 2019. https://www.510kdatabase.net/k190216/ 2019-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k190216-spaceflex-knee-fda-510k.jpg K190216 - SpaceFlex Knee K190216 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: G21, S.R.L.. Cleared Jun 2019. https://www.510kdatabase.net/k180952/ 2019-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k180952-ceramic-bracket-fda-510k.jpg K180952 - Ceramic Bracket K180952 is a FDA 510(k) cleared dental medical device. Manufacturer: Mem Dental Technology Co., Ltd.. Cleared Jun 2019. https://www.510kdatabase.net/k182145/ 2019-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k182145-tn-ultrasonic-tips-product-family-fda-510k.jpg K182145 - tün® ultrasonic tips product family K182145 is a FDA 510(k) cleared dental medical device. Manufacturer: Engineered Endodontics. Cleared Jun 2019. https://www.510kdatabase.net/k182429/ 2019-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k182429-masimo-o3-regional-oximeter-system-fda-510k.jpg K182429 - Masimo O3 Regional Oximeter System K182429 is a FDA 510(k) cleared neurology medical device. Manufacturer: Masimo Corporation. Cleared Jun 2019. https://www.510kdatabase.net/k182519/ 2019-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k182519-miha-bodytec-ii-fda-510k.jpg K182519 - Miha Bodytec II K182519 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Miha Bodytec GmbH. Cleared Jun 2019. https://www.510kdatabase.net/k182573/ 2019-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k182573-hailie-sensor-fda-510k.jpg K182573 - Hailie Sensor K182573 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Adherium (Nz), Ltd.. Cleared Jun 2019. https://www.510kdatabase.net/k183229/ 2019-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k183229-argen-clear-aligner-fda-510k.jpg K183229 - Argen Clear Aligner K183229 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Corporation. Cleared Jun 2019. https://www.510kdatabase.net/k183311/ 2019-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k183311-ivenix-infusion-system-iis-fda-510k.jpg K183311 - Ivenix Infusion System (IIS) K183311 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ivenix, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k183632/ 2019-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k183632-diagnostic-fixed-electrophysiology-fda-510k.jpg K183632 - Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable K183632 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baylis Medical Company, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k183649/ 2019-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k183649-diagnostic-fixed-electrophysiology-fda-510k.jpg K183649 - Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable K183649 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baylis Medical Company, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k190051/ 2019-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k190051-td-clip-fda-510k.jpg K190051 - TD Clip K190051 is a FDA 510(k) cleared dental medical device. Manufacturer: Zephyr Sleep Technologies, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k190057/ 2019-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k190057-djo-acetabular-system-fda-510k.jpg K190057 - DJO Acetabular System K190057 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Encore Medical, L.P.. Cleared Jun 2019. https://www.510kdatabase.net/k190388/ 2019-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k190388-rival-view-plating-systems-and-reduce-fda-510k.jpg K190388 - RIVAL View Plating Systems and Reduce Fracture Plating Systems K190388 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthofix Srl. Cleared Jun 2019. https://www.510kdatabase.net/k190503/ 2019-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k190503-ceraseal-fda-510k.jpg K190503 - CeraSeal K190503 is a FDA 510(k) cleared dental medical device. Manufacturer: Meta Biomed Co., Ltd.. Cleared Jun 2019. https://www.510kdatabase.net/k190916/ 2019-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k190916-vitalpatch-7d-biosensor-single-fda-510k.jpg K190916 - VitalPatch 7D Biosensor - single, VitalPatch 7D Biosensor - bag of 20 K190916 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vitalconnect, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k191231/ 2019-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k191231-andorate-auxiliary-water-connector-fda-510k.jpg K191231 - Andorate Auxiliary Water Connector, Andorate Valves Set K191231 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Smartdata Suzhou Co., Ltd.. Cleared Jun 2019. https://www.510kdatabase.net/k191316/ 2019-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k191316-vitros-xt-chemistry-products-alb-tp-fda-510k.jpg K191316 - VITROS XT Chemistry Products ALB-TP Slides K191316 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Ortho-Clinical Diagnostics, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/den180057/ 2019-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/den180057-ib-stim-fda-510k.jpg DEN180057 - IB-Stim DEN180057 is a FDA 510(k) cleared neurology medical device. Manufacturer: Innovative Health Solutions (Ihs), Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k183620/ 2019-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k183620-prostep-tbc-implant-system-fda-510k.jpg K183620 - PROSTEP TBC Implant System K183620 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jun 2019. https://www.510kdatabase.net/k190568/ 2019-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k190568-compas2-computerized-pulmonary-fda-510k.jpg K190568 - ComPAS2 (Computerized Pulmonary Analysis System) K190568 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Morgan Scientific, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k190616/ 2019-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k190616-vitek-2-ast-gram-positive-dalbavancin-fda-510k.jpg K190616 - VITEK 2 AST-Gram Positive Dalbavancin (<= 0.015 - >= 1 µg/mL) K190616 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k190618/ 2019-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k190618-rigel-peek-anterior-cervical-interbody-fda-510k.jpg K190618 - RIGEL PEEK Anterior Cervical Interbody Fusion System K190618 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: MiRus, LLC. Cleared Jun 2019. https://www.510kdatabase.net/k190827/ 2019-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k190827-luminelle-dtx-hysteroscopy-system-fda-510k.jpg K190827 - Luminelle DTx Hysteroscopy System, Luminelle 360 Rotatable Sterile Disposable Sheath Rigid K190827 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Uvision360, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k191043/ 2019-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k191043-da-vinci-handheld-camera-fda-510k.jpg K191043 - da Vinci Handheld Camera K191043 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k191220/ 2019-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k191220-pure-vu-system-fda-510k.jpg K191220 - Pure Vu System K191220 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Motus GI Medical Technologies , Ltd.. Cleared Jun 2019. https://www.510kdatabase.net/k191263/ 2019-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k191263-idys-alif-tivac-fda-510k.jpg K191263 - Idys ALIF TiVac K191263 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Clariance, Sas. Cleared Jun 2019. https://www.510kdatabase.net/k191335/ 2019-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k191335-veloxion-controller-kit-veloxion-fluid-fda-510k.jpg K191335 - Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags K191335 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Corinth Medtech, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k180671/ 2019-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k180671-mine-fda-510k.jpg K180671 - MINE K180671 is a FDA 510(k) cleared radiology medical device. Manufacturer: Rht Co., Ltd.. Cleared Jun 2019. https://www.510kdatabase.net/k183114/ 2019-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k183114-corin-bipolar-i-fda-510k.jpg K183114 - Corin BiPolar-i K183114 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corin U.S.A. Limited. Cleared Jun 2019. https://www.510kdatabase.net/k183559/ 2019-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k183559-watchpat-one-fda-510k.jpg K183559 - WatchPAT ONE K183559 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Itamar Medical , Ltd.. Cleared Jun 2019. https://www.510kdatabase.net/k190505/ 2019-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k190505-low-dose-lung-screening-option-fda-510k.jpg K190505 - Low Dose Lung Screening Option K190505 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Jun 2019. https://www.510kdatabase.net/k190576/ 2019-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k190576-walterlorenz-surgical-assist-arm-scope-fda-510k.jpg K190576 - WalterLorenz Surgical Assist Arm Scope Holder K190576 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Biomet Microfixation. Cleared Jun 2019. https://www.510kdatabase.net/k190585/ 2019-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k190585-biocode-gastrointestinal-pathogen-fda-510k.jpg K190585 - Biocode Gastrointestinal Pathogen Panel (GPP) K190585 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Applied BioCode, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k190595/ 2019-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k190595-signature-one-system-fda-510k.jpg K190595 - Signature ONE System K190595 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthosoft Inc. (d/b/a) Zimmer CAS. Cleared Jun 2019. https://www.510kdatabase.net/k190804/ 2019-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k190804-hydrocision-tenjet-device-fda-510k.jpg K190804 - HydroCision TenJet Device K190804 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Hydrocision, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k190874/ 2019-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k190874-materialise-mimics-enlight-fda-510k.jpg K190874 - Materialise Mimics Enlight K190874 is a FDA 510(k) cleared radiology medical device. Manufacturer: Materialise NV. Cleared Jun 2019. https://www.510kdatabase.net/k191307/ 2019-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k191307-palm-bladder-scanner-pbsv51-fda-510k.jpg K191307 - Palm Bladder Scanner - PBSV5.1 K191307 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mianyang Meike Electronic Equipment Co., Ltd.. Cleared Jun 2019. https://www.510kdatabase.net/k183533/ 2019-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k183533-unity-total-knee-system-fda-510k.jpg K183533 - Unity Total Knee System K183533 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corin U.S.A. Limited. Cleared Jun 2019. https://www.510kdatabase.net/k183535/ 2019-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k183535-fully-automatic-electronic-blood-fda-510k.jpg K183535 - Fully Automatic Electronic Blood Pressure Monitor K183535 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Andon Health Co, Ltd.. Cleared Jun 2019. https://www.510kdatabase.net/k190068/ 2019-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k190068-vanguard-xp-knee-system-fda-510k.jpg K190068 - Vanguard XP Knee System K190068 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k190245/ 2019-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k190245-pds-barbed-suture-pdo-maxx-threads-fda-510k.jpg K190245 - PDS Barbed Suture, PDO MAXX Threads K190245 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Pdo Max, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k190461/ 2019-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k190461-achieva-15t-30t-and-intera-15t-mr-fda-510k.jpg K190461 - Achieva 1.5T, 3.0T and Intera 1.5T MR Systems K190461 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Jun 2019. https://www.510kdatabase.net/k190573/ 2019-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k190573-kowa-dr-1a-fda-510k.jpg K190573 - KOWA DR-1a K190573 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Kowa Company , Ltd.. Cleared Jun 2019. https://www.510kdatabase.net/k190579/ 2019-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k190579-td-4183-blood-glucose-monitoring-system-fda-510k.jpg K190579 - TD-4183 Blood Glucose Monitoring System K190579 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Taidoc Technology Corporation. Cleared Jun 2019. https://www.510kdatabase.net/k190892/ 2019-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k190892-mectascrew-peek-interference-screw-fda-510k.jpg K190892 - MectaScrew PEEK Interference Screw K190892 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Jun 2019. https://www.510kdatabase.net/k191340/ 2019-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k191340-cortrak-2-equilateral-enteral-access-fda-510k.jpg K191340 - CORTRAK* 2 Equilateral Enteral Access System K191340 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Avanos Medical, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k182503/ 2019-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k182503-sterilizable-internal-defibrillation-fda-510k.jpg K182503 - Sterilizable Internal Defibrillation Paddles for use with LIFEPAK defibrillators/monitors K182503 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Physio-Control, Inc.. Cleared Jun 2019. https://www.510kdatabase.net/k182625/ 2019-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k182625-diapex-plus-fda-510k.jpg K182625 - Diapex Plus K182625 is a FDA 510(k) cleared dental medical device. Manufacturer: DiaDent Group International. Cleared Jun 2019. https://www.510kdatabase.net/k190337/ 2019-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k190337-rewalk-restore-fda-510k.jpg K190337 - ReWalk Restore K190337 is a FDA 510(k) cleared neurology medical device. Manufacturer: Re Walk Robotics , Ltd.. Cleared Jun 2019. https://www.510kdatabase.net/k191185/ 2019-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k191185-solanas-posterior-oct-fixation-system-fda-510k.jpg K191185 - Solanas® Posterior OCT Fixation System K191185 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine. Cleared Jun 2019. https://www.510kdatabase.net/k190564/ 2019-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k190564-rightest-blood-glucose-monitoring-fda-510k.jpg K190564 - Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB K190564 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bionime Corporation. Cleared Jun 2019. https://www.510kdatabase.net/k190572/ 2019-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k190572-erchonia-fx-635-fda-510k.jpg K190572 - Erchonia FX-635 K190572 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Erchonia Corporation. Cleared Jun 2019. https://www.510kdatabase.net/k182443/ 2019-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k182443-pristine-hemodialysis-catheter-fda-510k.jpg K182443 - Pristine Hemodialysis Catheter K182443 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Pristine Access Technologies , Ltd.. Cleared May 2019. https://www.510kdatabase.net/k182678/ 2019-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k182678-zimmer-ml-taper-hip-prosthesis-with-fda-510k.jpg K182678 - Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology MR Labeling K182678 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared May 2019. https://www.510kdatabase.net/k182725/ 2019-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k182725-apis-fda-510k.jpg K182725 - Apis K182725 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sweetbio, Inc.. Cleared May 2019. https://www.510kdatabase.net/k190194/ 2019-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k190194-c2-cryoballoon-catheter-pear-c2-fda-510k.jpg K190194 - C2 CryoBalloon Catheter (Pear), C2 CryoBalloon (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge K190194 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Pentax Medical, A Division of Pentax of America, Inc.. Cleared May 2019. https://www.510kdatabase.net/k190240/ 2019-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k190240-tiger-sharps-containers-fda-510k.jpg K190240 - Tiger Sharps Containers K190240 is a FDA 510(k) cleared general hospital medical device. Manufacturer: International Marketing Specialists, Inc.. Cleared May 2019. https://www.510kdatabase.net/k190246/ 2019-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k190246-neuroshield-fda-510k.jpg K190246 - NeuroShield K190246 is a FDA 510(k) cleared neurology medical device. Manufacturer: Monarch Bioimplants GmbH. Cleared May 2019. https://www.510kdatabase.net/k190310/ 2019-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k190310-u-deliver-bolink-enfit-enteral-feeding-fda-510k.jpg K190310 - U Deliver Bolink ENFit Enteral Feeding Sets K190310 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: U Deliver Medical, LLC. Cleared May 2019. https://www.510kdatabase.net/k190543/ 2019-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k190543-cannulated-hemi-implant-fda-510k.jpg K190543 - Cannulated Hemi Implant K190543 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Vilex IN Tennessee, Inc.. Cleared May 2019. https://www.510kdatabase.net/k190546/ 2019-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k190546-nexxt-matrixx-stand-alone-cervical-fda-510k.jpg K190546 - NEXXT MATRIXX Stand Alone Cervical System K190546 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nexxt Spine, LLC. Cleared May 2019. https://www.510kdatabase.net/k190565/ 2019-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k190565-cervical-plate-fda-510k.jpg K190565 - Cervical Plate K190565 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Eisertech, LLC. Cleared May 2019. https://www.510kdatabase.net/k190757/ 2019-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k190757-magnetom-avanto-fit-fda-510k.jpg K190757 - MAGNETOM Avanto Fit K190757 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solution USA, Inc.. Cleared May 2019. https://www.510kdatabase.net/k190766/ 2019-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k190766-palacos-fast-rg-fda-510k.jpg K190766 - PALACOS fast R+G K190766 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Heraeus Medical GmbH. Cleared May 2019. https://www.510kdatabase.net/k190831/ 2019-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k190831-e240ag-lcd-monitor-e240a-lcd-monitor-fda-510k.jpg K190831 - E240AG LCD Monitor, E240A LCD Monitor, JUSHA-E240AG LCD Monitor, JUJSHA-E240A LCD Monitor, C230A LCD Monitor, JUSHA-C230A LCD Monitor, C230M LCD Monitor, JUSHA-C230M LCD Monitor K190831 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Nanjing Jusha Display Technology Co., Ltd.. Cleared May 2019. https://www.510kdatabase.net/k190896/ 2019-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k190896-briefcase-fda-510k.jpg K190896 - BriefCase K190896 is a FDA 510(k) cleared radiology medical device. Manufacturer: Aidoc Medical , Ltd.. Cleared May 2019. https://www.510kdatabase.net/k173158/ 2019-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k173158-air-relax-fda-510k.jpg K173158 - Air Relax K173158 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Maxstar Industrial Co., Ltd.. Cleared May 2019. https://www.510kdatabase.net/k182308/ 2019-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k182308-non-sterile-powder-free-nitrile-fda-510k.jpg K182308 - Non-Sterile, Powder-Free Nitrile Examination Glove Pink Tested for use with Chemotherapy Drugs K182308 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sri Trang Gloves (Thailand) Co., Ltd.. Cleared May 2019. https://www.510kdatabase.net/k182611/ 2019-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k182611-qangio-xa-3d-fda-510k.jpg K182611 - Qangio XA 3D K182611 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medis Medical Imaging Systems BV. Cleared May 2019. https://www.510kdatabase.net/k182660/ 2019-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k182660-galttws-fda-510k.jpg K182660 - GaltTWS K182660 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Galt Medical Corp.. Cleared May 2019. https://www.510kdatabase.net/k183205/ 2019-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k183205-purebmc-supraphysiologic-concentrating-fda-510k.jpg K183205 - PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System K183205 is a FDA 510(k) cleared hematology medical device. Manufacturer: Emcyte Corporation. Cleared May 2019. https://www.510kdatabase.net/k190160/ 2019-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k190160-nexus-ultrasonic-surgical-aspirator-fda-510k.jpg K190160 - neXus Ultrasonic Surgical Aspirator System K190160 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Misonix, Inc.. Cleared May 2019. https://www.510kdatabase.net/k190623/ 2019-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k190623-cardioblate-pen-surgical-ablation-fda-510k.jpg K190623 - Cardioblate Pen Surgical Ablation Device, Cardioblate XL Pen Surgical Ablation Device K190623 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic. Cleared May 2019. https://www.510kdatabase.net/k190628/ 2019-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k190628-flexseal-introducer-sheath-with-fda-510k.jpg K190628 - FlexSeal Introducer Sheath with Hydrophilic Coating K190628 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Freudenberg Medical Mis, Inc.. Cleared May 2019. https://www.510kdatabase.net/k191067/ 2019-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k191067-arc-endocuff-glide-aeg110-aeg120-fda-510k.jpg K191067 - Arc Endocuff Glide AEG110 & AEG120 K191067 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boddingtons Plastics, Ltd.. Cleared May 2019. https://www.510kdatabase.net/k191145/ 2019-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k191145-masterloc-extension-fda-510k.jpg K191145 - MasterLoc Extension K191145 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared May 2019. https://www.510kdatabase.net/k191188/ 2019-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k191188-ashk100g-fda-510k.jpg K191188 - ASHK100G K191188 is a FDA 510(k) cleared radiology medical device. Manufacturer: Lg Electronics. Cleared May 2019. https://www.510kdatabase.net/k181630/ 2019-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k181630-revolution-external-plating-system-fda-510k.jpg K181630 - Revolution External Plating System K181630 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: New Standard Device Dba Metalogix. Cleared May 2019. https://www.510kdatabase.net/k182403/ 2019-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k182403-peel-away-introducer-fda-510k.jpg K182403 - Peel-Away Introducer K182403 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared May 2019. https://www.510kdatabase.net/k182526/ 2019-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k182526-fetal-doppler-models-fd-231b-fd-231d-fda-510k.jpg K182526 - Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D) K182526 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Vcomin Technology Limited. Cleared May 2019. https://www.510kdatabase.net/k182716/ 2019-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k182716-brain-perfusion-bp-application-fda-510k.jpg K182716 - Brain Perfusion (BP) application K182716 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared May 2019. https://www.510kdatabase.net/k182910/ 2019-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k182910-segmented-esophageal-stent-system-fda-510k.jpg K182910 - Segmented Esophageal Stent System K182910 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Micro-Tech (Nanjing) Co., Ltd.. Cleared May 2019. https://www.510kdatabase.net/k183084/ 2019-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k183084-fuji-cervical-plate-system-fda-510k.jpg K183084 - Fuji Cervical Plate System K183084 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Altus Partners, LLC. Cleared May 2019. https://www.510kdatabase.net/k183336/ 2019-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k183336-entuit-peg-entuit-pegj-fda-510k.jpg K183336 - Entuit PEG, Entuit PEGJ K183336 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Wilson-Cook Medical, Inc.. Cleared May 2019. https://www.510kdatabase.net/k183337/ 2019-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k183337-luxacrown-shade-a1-a2-a3-a35-fda-510k.jpg K183337 - LuxaCrown, Shade A1, A2, A3, A3.5 K183337 is a FDA 510(k) cleared dental medical device. Manufacturer: Dmg Chemisch Pharmazeutische Fabrik GmbH. Cleared May 2019. https://www.510kdatabase.net/k183645/ 2019-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k183645-silver-high-performance-dressing-fda-510k.jpg K183645 - Silver High Performance Dressing K183645 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Advanced Medical Solutions, Ltd.. Cleared May 2019. https://www.510kdatabase.net/k190167/ 2019-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k190167-mitraclip-g4-steerable-guide-catheter-fda-510k.jpg K190167 - MitraClip G4 Steerable Guide Catheter K190167 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott. Cleared May 2019. https://www.510kdatabase.net/k190510/ 2019-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k190510-guttasil-fda-510k.jpg K190510 - GuttaSil K190510 is a FDA 510(k) cleared dental medical device. Manufacturer: Meta Biomed Co., Ltd.. Cleared May 2019. https://www.510kdatabase.net/k190534/ 2019-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k190534-manual-wheelchair-sivfh2a102-fda-510k.jpg K190534 - Manual Wheelchair SIVFH2A102 K190534 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Jiangsu Horizon Medical Science & Technology Co., Ltd.. Cleared May 2019. https://www.510kdatabase.net/k190877/ 2019-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k190877-juliet-ti-ll-lumbar-interbody-device-fda-510k.jpg K190877 - Juliet® Ti LL Lumbar Interbody Device K190877 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spineart. Cleared May 2019. https://www.510kdatabase.net/k190914/ 2019-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k190914-mts-doxycycline-0016-256-gml-fda-510k.jpg K190914 - MTS Doxycycline 0.016 - 256 µg/mL K190914 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Liofilchem S. R. L.. Cleared May 2019. https://www.510kdatabase.net/k191122/ 2019-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k191122-3m-relyx-pediatric-resin-modified-fda-510k.jpg K191122 - 3M RelyX Pediatric Resin Modified Glass Ionomer Cement K191122 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Espe Dental Products. Cleared May 2019. https://www.510kdatabase.net/k191124/ 2019-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k191124-swiss-lithoclast-trilogy-fda-510k.jpg K191124 - Swiss LithoClast Trilogy K191124 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: E.M.S Electro Medical Systems S.A. Cleared May 2019. https://www.510kdatabase.net/k191157/ 2019-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k191157-umr-780-umr-790-fda-510k.jpg K191157 - uMR 780, uMR 790 K191157 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared May 2019. https://www.510kdatabase.net/k180739/ 2019-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k180739-clearlink-system-solution-set-fda-510k.jpg K180739 - Clearlink System Solution Set K180739 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corporation. Cleared May 2019. https://www.510kdatabase.net/k182544/ 2019-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k182544-accelfix-spinal-fixation-system-fda-510k.jpg K182544 - AccelFix Spinal Fixation System K182544 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: L & K Biomed Co., Ltd.. Cleared May 2019. https://www.510kdatabase.net/k190468/ 2019-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k190468-nihon-kohden-svm-7200-series-vital-fda-510k.jpg K190468 - Nihon Kohden SVM-7200 Series Vital Signs Monitor K190468 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden Corporation. Cleared May 2019. https://www.510kdatabase.net/k190474/ 2019-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k190474-mectalock-peek-suture-anchor-fda-510k.jpg K190474 - MectaLock PEEK Suture Anchor K190474 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared May 2019. https://www.510kdatabase.net/k190482/ 2019-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k190482-ignite-bone-void-filler-fda-510k.jpg K190482 - IGNITE Bone Void Filler K190482 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared May 2019. https://www.510kdatabase.net/k190606/ 2019-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k190606-powder-free-nitrile-patient-fda-510k.jpg K190606 - Powder Free Nitrile Patient Examination Glove, Black Colored, Non-Sterile K190606 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Kossan International Sdn Bhd. Cleared May 2019. https://www.510kdatabase.net/k190686/ 2019-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k190686-optilite-igm-csf-kit-fda-510k.jpg K190686 - Optilite IgM CSF Kit K190686 is a FDA 510(k) cleared immunology medical device. Manufacturer: The Binding Site Group , Ltd.. Cleared May 2019. https://www.510kdatabase.net/k182515/ 2019-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k182515-surgical-face-mask-fda-510k.jpg K182515 - Surgical Face Mask K182515 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wuhan Dymex Healthcare Co., Ltd.. Cleared May 2019. https://www.510kdatabase.net/k181157/ 2019-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k181157-conical-plus-implant-system-fda-510k.jpg K181157 - Conical Plus Implant System K181157 is a FDA 510(k) cleared dental medical device. Manufacturer: Osseofuse International, Inc.. Cleared May 2019. https://www.510kdatabase.net/k181979/ 2019-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k181979-rusch-flocath-quick-18-fr-coud-fda-510k.jpg K181979 - Rusch FloCath Quick 18 Fr. Coudé Hydrophilic Intermittent Catheter K181979 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Teleflexmedical, Inc.. Cleared May 2019. https://www.510kdatabase.net/k182321/ 2019-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k182321-mobilelink-acetabular-cup-system-fda-510k.jpg K182321 - MobileLink Acetabular Cup System K182321 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Waldemar Link GmbH & Co. KG. Cleared May 2019. https://www.510kdatabase.net/k182575/ 2019-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k182575-jaysun-powder-free-vinyl-patient-fda-510k.jpg K182575 - Jaysun Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) K182575 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangxi Jaysun Medcare Co., Ltd.. Cleared May 2019. https://www.510kdatabase.net/k183530/ 2019-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k183530-trudiagnosis-system-fda-510k.jpg K183530 - TruDiagnosis System K183530 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Akonni Biosystems, Inc.. Cleared May 2019. https://www.510kdatabase.net/k190077/ 2019-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k190077-biogel-pi-ultratouch-s-surgical-glove-fda-510k.jpg K190077 - Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove K190077 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Molnlycke Health Care Us, LLC. Cleared May 2019. https://www.510kdatabase.net/k190231/ 2019-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k190231-incore-lapidus-sterile-kits-fda-510k.jpg K190231 - InCore® Lapidus Sterile Kits K190231 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nextremity Solutions, Inc.. Cleared May 2019. https://www.510kdatabase.net/k190282/ 2019-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k190282-quantum-smart-occluder-lh-left-hand-fda-510k.jpg K190282 - Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand) K190282 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Spectrum Medical , Ltd.. Cleared May 2019. https://www.510kdatabase.net/k190378/ 2019-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k190378-spirotome-endo-08-gauge-spirotome-endo-fda-510k.jpg K190378 - Spirotome Endo 08 Gauge, Spirotome Endo 10 Gauge, Spirotome Endo 14 Gauge, Spirotome Endo 14 Gauge with 10 mm Helix K190378 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Bioncise NV. Cleared May 2019. https://www.510kdatabase.net/k190448/ 2019-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k190448-lightlas-pattern-scanning-system-fda-510k.jpg K190448 - LightLas Pattern Scanning System - TruScan Pro K190448 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Light-Med(Usa), Inc.. Cleared May 2019. https://www.510kdatabase.net/k190542/ 2019-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k190542-soliton-acoustic-wave-device-fda-510k.jpg K190542 - Soliton Acoustic Wave Device K190542 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Soliton, Inc.. Cleared May 2019. https://www.510kdatabase.net/k190603/ 2019-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k190603-tria-firm-ureteral-stent-fda-510k.jpg K190603 - Tria Firm Ureteral Stent K190603 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared May 2019. https://www.510kdatabase.net/k190802/ 2019-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k190802-envision-ultrasound-pad-and-cover-fda-510k.jpg K190802 - Envision ultrasound pad and cover K190802 is a FDA 510(k) cleared radiology medical device. Manufacturer: Civco Medical Solutions. Cleared May 2019. https://www.510kdatabase.net/k191083/ 2019-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k191083-complete-control-system-gen2-fda-510k.jpg K191083 - COMPLETE CONTROL System Gen2 K191083 is a FDA 510(k) cleared neurology medical device. Manufacturer: Coapt, LLC. Cleared May 2019. https://www.510kdatabase.net/k182362/ 2019-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k182362-maxcap-ped-and-maxcap-neo-fda-510k.jpg K182362 - MaxCap Ped and MaxCap Neo K182362 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Maxtec, LLC. Cleared May 2019. https://www.510kdatabase.net/k182390/ 2019-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k182390-impede-fx-embolization-plug-fda-510k.jpg K182390 - IMPEDE-FX Embolization Plug K182390 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shape Memory Medical. Cleared May 2019. https://www.510kdatabase.net/k182458/ 2019-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k182458-longterm-npwt-foam-dressing-kit-fda-510k.jpg K182458 - Longterm NPWT Foam Dressing Kit K182458 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Zhejiang Longterm Medical Technology Co., Ltd.. Cleared May 2019. https://www.510kdatabase.net/k182937/ 2019-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k182937-upstream-goback-crossing-catheter-fda-510k.jpg K182937 - Upstream GoBack Crossing Catheter K182937 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Upstream Peripheral Technologies, Ltd.. Cleared May 2019. https://www.510kdatabase.net/k183054/ 2019-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k183054-synmesh-system-fda-510k.jpg K183054 - SYNMESH System K183054 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Synthes Spine. Cleared May 2019. https://www.510kdatabase.net/k183560/ 2019-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k183560-luna-3d-gen2-interbody-fusion-system-fda-510k.jpg K183560 - Luna 3D GEN2 Interbody Fusion System K183560 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Benvenue Medical, Inc.. Cleared May 2019. https://www.510kdatabase.net/k183639/ 2019-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k183639-mariner-outrigger-revision-system-fda-510k.jpg K183639 - Mariner Outrigger Revision System K183639 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared May 2019. https://www.510kdatabase.net/k183654/ 2019-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k183654-pentax-medical-eb-1970uk-ultrasound-fda-510k.jpg K183654 - PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION Preirus K183654 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Pentax of America, Inc.. Cleared May 2019. https://www.510kdatabase.net/k190018/ 2019-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k190018-gammex-non-latex-pi-white-polyisoprene-fda-510k.jpg K190018 - Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs K190018 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ansell Healthcare Products, LLC. Cleared May 2019. https://www.510kdatabase.net/k190436/ 2019-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k190436-katana-zirconia-block-fda-510k.jpg K190436 - KATANA Zirconia Block K190436 is a FDA 510(k) cleared dental medical device. Manufacturer: Kuraray Noritake Dental, Inc.. Cleared May 2019. https://www.510kdatabase.net/k190441/ 2019-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k190441-xpert-ctng-genexpert-dx-system-fda-510k.jpg K190441 - Xpert CT/NG, GeneXpert Dx System, GeneXpert Infinity-48s and GeneXpert Infinity-80 Systems, GeneXpert Infinity-48 System, Xpert Vaginal/Endocervical Specimen Collection, Xpert Urine Specimen Collection Kit, Xpert Swab Specimen Collection Kit K190441 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Cepheid. Cleared May 2019. https://www.510kdatabase.net/k190452/ 2019-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k190452-aptima-bv-assay-fda-510k.jpg K190452 - Aptima BV Assay K190452 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Hologic, Inc.. Cleared May 2019. https://www.510kdatabase.net/k190469/ 2019-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k190469-erbeflo-2-disposable-tubing-system-fda-510k.jpg K190469 - ERBEFLO 2 Disposable Tubing System K190469 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Erbe USA, Inc.. Cleared May 2019. https://www.510kdatabase.net/k190515/ 2019-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k190515-aptima-combo-2-assay-panther-system-fda-510k.jpg K190515 - Aptima Combo 2 Assay (Panther System) K190515 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Hologic, Inc.. Cleared May 2019. https://www.510kdatabase.net/k191091/ 2019-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k191091-rampart-one-lumbar-interbody-fusion-fda-510k.jpg K191091 - Rampart One Lumbar Interbody Fusion System K191091 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spineology, Inc.. Cleared May 2019. https://www.510kdatabase.net/den180032/ 2019-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/den180032-synovasure-alpha-defensin-lateral-flow-fda-510k.jpg DEN180032 - Synovasure Alpha Defensin Lateral Flow Test Kit, Synovasure Alpha Defensin Lateral Flow Test Kit (5 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (10 Test), Synovasure Alpha Defensin Lateral Flow Test Kit (30 Test), Synovasure Alpha Defensin Control Kit DEN180032 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Cd Diagnostics, Inc.. Cleared May 2019. https://www.510kdatabase.net/den180069/ 2019-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/den180069-zikv-detect-20-igm-capture-elisa-fda-510k.jpg DEN180069 - ZIKV Detect 2.0 IgM Capture ELISA DEN180069 is a FDA 510(k) cleared microbiology medical device. Manufacturer: InBios International, Inc.. Cleared May 2019. https://www.510kdatabase.net/k182350/ 2019-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k182350-dental-ceramic-fda-510k.jpg K182350 - Dental Ceramic K182350 is a FDA 510(k) cleared dental medical device. Manufacturer: Baot Biological Technology Co., Ltd.. Cleared May 2019. https://www.510kdatabase.net/k182374/ 2019-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k182374-liac-s-fda-510k.jpg K182374 - LIAC S K182374 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sit Sordina Iort Technologies Spa. Cleared May 2019. https://www.510kdatabase.net/k183611/ 2019-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k183611-soniquence-rf-generator-and-soniquence-fda-510k.jpg K183611 - Soniquence RF Generator and Soniquence Electrodes K183611 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Soniquence, LLC. Cleared May 2019. https://www.510kdatabase.net/k183644/ 2019-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k183644-stealth-midas-mr8-system-fda-510k.jpg K183644 - Stealth-Midas MR8 System K183644 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Powered Surgical Solutions. Cleared May 2019. https://www.510kdatabase.net/k190433/ 2019-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k190433-cobas-tvmg-for-use-on-cobas-68008800-fda-510k.jpg K190433 - cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit K190433 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Molecular Systems, Inc.. Cleared May 2019. https://www.510kdatabase.net/k190444/ 2019-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k190444-hera-i10-diagnostic-ultrasound-system-fda-510k.jpg K190444 - HERA I10 Diagnostic Ultrasound System K190444 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Medison Co., Ltd.. Cleared May 2019. https://www.510kdatabase.net/k190751/ 2019-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k190751-connector-system-fda-510k.jpg K190751 - Connector System K190751 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthofix, Inc.. Cleared May 2019. https://www.510kdatabase.net/k190769/ 2019-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k190769-bladder-scanner-models-m2-m2-w-m1-m1-w-fda-510k.jpg K190769 - Bladder Scanner (Models: M2, M2-W, M1, M1-W) K190769 is a FDA 510(k) cleared radiology medical device. Manufacturer: Suzhou Lischka Medtech Co., Ltd.. Cleared May 2019. https://www.510kdatabase.net/k190823/ 2019-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k190823-erbe-esu-model-vio-3-with-accessories-fda-510k.jpg K190823 - Erbe ESU Model VIO 3 with Accessories K190823 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Erbe Elektromedizin GmbH. Cleared May 2019. https://www.510kdatabase.net/k190902/ 2019-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k190902-rh-non-automated-blood-pressure-meter-fda-510k.jpg K190902 - RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter with Stethoscope K190902 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Wenzhou Renhua Instruments Co., Ltd.. Cleared May 2019. https://www.510kdatabase.net/k191080/ 2019-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k191080-ambu-ascope-4-rhinolaryngo-slim-fda-510k.jpg K191080 - Ambu aScope 4 RhinoLaryngo Slim K191080 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Ambu A/S. Cleared May 2019. https://www.510kdatabase.net/k182342/ 2019-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k182342-intralock-lapidus-system-fda-510k.jpg K182342 - IntraLock Lapidus System K182342 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Fusion Orthopedics, LLC. Cleared May 2019. https://www.510kdatabase.net/k182576/ 2019-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k182576-solax-powered-wheelchair-fda-510k.jpg K182576 - Solax Powered Wheelchair K182576 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Dongguan Prestige Sporting Goods Co., Ltd.. Cleared May 2019. https://www.510kdatabase.net/k182711/ 2019-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k182711-customized-craniofacial-implant-cci-fda-510k.jpg K182711 - Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) K182711 is a FDA 510(k) cleared neurology medical device. Manufacturer: Kelyniam Global, Inc.. Cleared May 2019. https://www.510kdatabase.net/k182975/ 2019-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k182975-mako-7-fda-510k.jpg K182975 - MAKO 7 K182975 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Boston Scientific Corporation. Cleared May 2019. https://www.510kdatabase.net/k183242/ 2019-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k183242-et-iv-sa-dental-implants-fda-510k.jpg K183242 - ET IV SA Dental Implants K183242 is a FDA 510(k) cleared dental medical device. Manufacturer: Hiossen, Inc.. Cleared May 2019. https://www.510kdatabase.net/k183646/ 2019-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k183646-acumen-hypotension-prediction-index-fda-510k.jpg K183646 - Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure K183646 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifeciences, LLC. Cleared May 2019. https://www.510kdatabase.net/k190367/ 2019-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k190367-smith-nephew-tablet-application-fda-510k.jpg K190367 - Smith & Nephew Tablet Application K190367 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew. Cleared May 2019. https://www.510kdatabase.net/k182235/ 2019-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k182235-onsite-waste-sharps-container-fda-510k.jpg K182235 - OnSite Waste Sharps Container K182235 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bluestone Medical, Inc.. Cleared May 2019. https://www.510kdatabase.net/k183655/ 2019-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k183655-versacross-transseptal-sheath-fda-510k.jpg K183655 - VersaCross Transseptal Sheath K183655 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baylis Medical Company, Inc.. Cleared May 2019. https://www.510kdatabase.net/k190134/ 2019-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k190134-full-automatic-nibp-blood-pressure-fda-510k.jpg K190134 - Full Automatic (NIBP) Blood Pressure Monitor-HL158TB K190134 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Health & Life Co., Ltd.. Cleared May 2019. https://www.510kdatabase.net/k190332/ 2019-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k190332-aperio-at2-dx-system-fda-510k.jpg K190332 - Aperio AT2 DX System K190332 is a FDA 510(k) cleared pathology medical device. Manufacturer: Leica Biosystems Imaging, Inc.. Cleared May 2019. https://www.510kdatabase.net/den180059/ 2019-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/den180059-nerivio-migra-fda-510k.jpg DEN180059 - Nerivio Migra DEN180059 is a FDA 510(k) cleared neurology medical device. Manufacturer: Theranica Bioelectronics , Ltd.. Cleared May 2019. https://www.510kdatabase.net/k190125/ 2019-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k190125-fiberstitch-implant-curved-with-two-fda-510k.jpg K190125 - FiberStitch Implant, Curved with two Polyester Implants and 2-0 FiberWire, FiberStitch Implant, Straight with two Polyester Implants and 2-0 FiberWire K190125 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: T.A.G. Medical Products Corporation, Ltd.. Cleared May 2019. https://www.510kdatabase.net/k183597/ 2019-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k183597-qiastat-dx-respiratory-panel-fda-510k.jpg K183597 - QIAstat-Dx Respiratory Panel K183597 is a FDA 510(k) cleared microbiology medical device. Manufacturer: QIAGEN GmbH. Cleared May 2019. https://www.510kdatabase.net/k173570/ 2019-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k173570-sd-abutment-fda-510k.jpg K173570 - SD Abutment K173570 is a FDA 510(k) cleared dental medical device. Manufacturer: Surgident Co., Ltd.. Cleared May 2019. https://www.510kdatabase.net/k182252/ 2019-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k182252-cook-unimpregnated-central-venous-fda-510k.jpg K182252 - Cook Unimpregnated Central Venous Catheter K182252 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cook Incorporated. Cleared May 2019. https://www.510kdatabase.net/k182302/ 2019-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k182302-cardiogard-emboli-protection-cannula-fda-510k.jpg K182302 - CardioGard Emboli Protection Cannula K182302 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cardiogard Medical, Ltd.. Cleared May 2019. https://www.510kdatabase.net/k182394/ 2019-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k182394-wizard-310320-series-cpap-mask-fda-510k.jpg K182394 - WiZARD 310/320 Series CPAP Mask K182394 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Apex Medical Corp.. Cleared May 2019. https://www.510kdatabase.net/k183035/ 2019-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k183035-percutaneous-entry-set-skinny-needler-fda-510k.jpg K183035 - Percutaneous Entry Set, Skinny Needle(R) with Chiba Tip, Disposable Two-part Trocar Needle K183035 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared May 2019. https://www.510kdatabase.net/k183077/ 2019-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k183077-delta-xtend-reverse-shoulder-system-fda-510k.jpg K183077 - Delta Xtend Reverse Shoulder System K183077 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy(Ireland). Cleared May 2019. https://www.510kdatabase.net/k183381/ 2019-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k183381-navigation-enabled-instruments-fda-510k.jpg K183381 - Navigation Enabled Instruments K183381 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker. Cleared May 2019. https://www.510kdatabase.net/k183417/ 2019-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k183417-irestore-professional-282-fda-510k.jpg K183417 - iRestore Professional 282 K183417 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Freedom Laser Therapy, Inc.. Cleared May 2019. https://www.510kdatabase.net/k183505/ 2019-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k183505-ky-banksy-moisture-fda-510k.jpg K183505 - KY Banksy Moisture K183505 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Rb Health (Us), LLC. Cleared May 2019. https://www.510kdatabase.net/k183618/ 2019-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k183618-revolution-radial-head-fda-510k.jpg K183618 - Revolution Radial Head K183618 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ignite Orthopedics, Inc.. Cleared May 2019. https://www.510kdatabase.net/k190675/ 2019-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k190675-dimension-exl-high-sensitivity-fda-510k.jpg K190675 - Dimension EXL High-Sensitivity Troponin I (TNIH) Assay K190675 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared May 2019. https://www.510kdatabase.net/k191015/ 2019-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k191015-soft-pass-embryo-mock-transfer-fda-510k.jpg K191015 - Soft-Pass Embryo Mock Transfer Catheter Sets (Soft-Pass Embryo Mock Transfer Catheter Set and Soft-Pass Embryo Mock Transfer Catheter Set with Echogenic Tip) K191015 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Cook Incorporated. Cleared May 2019. https://www.510kdatabase.net/k191025/ 2019-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k191025-drx-revolution-mobile-x-ray-system-fda-510k.jpg K191025 - DRX-Revolution Mobile X-ray System K191025 is a FDA 510(k) cleared radiology medical device. Manufacturer: Carestream Health, Inc.. Cleared May 2019. https://www.510kdatabase.net/k191029/ 2019-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k191029-affinity-nttm-oxygenator-model-511-fda-510k.jpg K191029 - Affinity NTTM Oxygenator (Model 511), Affinity® NT Hollow Fiber Oxygenator with Plasma Resistant Fiber (PRF) with TrilliumTM Biosurface (Model 511T), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541), Affinity® NT Integrated CVR/Membrane Oxygenator with Plasma Resistant Fiber (Model 541-R), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurface (Model 541T), Affinity NT® Integrated CVR/Membrane Oxygenator with Trillium® Biosurfac K191029 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared May 2019. https://www.510kdatabase.net/k173895/ 2019-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k173895-tel-o-graph-fda-510k.jpg K173895 - Tel-O-Graph K173895 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: I.E.M. Industrielle Entwicklung and Medizintechnik. Cleared May 2019. https://www.510kdatabase.net/k182251/ 2019-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k182251-evolution-nitrx-medial-pivot-knee-fda-510k.jpg K182251 - EVOLUTION NitrX Medial-Pivot Knee K182251 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Mircoport Orthopedics, Inc.. Cleared May 2019. https://www.510kdatabase.net/k182734/ 2019-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k182734-unicon-hydrogel-with-unicon-polymer-fda-510k.jpg K182734 - Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contac K182734 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Unicon Optical Co., Ltd.. Cleared May 2019. https://www.510kdatabase.net/k183534/ 2019-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k183534-fully-automatic-electronic-blood-fda-510k.jpg K183534 - Fully Automatic Electronic Blood Pressure Monitor K183534 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Andon Health Co, Ltd.. Cleared May 2019. https://www.510kdatabase.net/k190345/ 2019-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k190345-vpc-fda-510k.jpg K190345 - VPC K190345 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: PAJUNK GmbH Medizintechnologie. Cleared May 2019. https://www.510kdatabase.net/k190355/ 2019-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k190355-precision-casting-solutions-total-knee-fda-510k.jpg K190355 - Precision Casting Solutions Total Knee System K190355 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Precision Casting Solutions, Inc.. Cleared May 2019. https://www.510kdatabase.net/k190372/ 2019-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k190372-aveta-system-fda-510k.jpg K190372 - Aveta System K190372 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Meditrina, Inc.. Cleared May 2019. https://www.510kdatabase.net/k190472/ 2019-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k190472-aptima-cvtv-assay-fda-510k.jpg K190472 - Aptima CV/TV Assay K190472 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Hologic, Inc.. Cleared May 2019. https://www.510kdatabase.net/k191000/ 2019-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k191000-carnation-ambulatory-monitor-fda-510k.jpg K191000 - Carnation Ambulatory Monitor K191000 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bardy Diagnostics, Inc.. Cleared May 2019. https://www.510kdatabase.net/k191023/ 2019-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k191023-dolphiniq-dolphin4d-and-dolphinmax-fda-510k.jpg K191023 - Dolphin/IQ, Dolphin/4D and Dolphin/MAX K191023 is a FDA 510(k) cleared radiology medical device. Manufacturer: Viasonix , Ltd.. Cleared May 2019. https://www.510kdatabase.net/k191040/ 2019-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k191040-syngovia-version-vb40a-fda-510k.jpg K191040 - syngo.via (Version VB40A) K191040 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Healthcare GmbH. Cleared May 2019. https://www.510kdatabase.net/k191051/ 2019-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k191051-argos-fda-510k.jpg K191051 - ARGOS K191051 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Santec Corporation. Cleared May 2019. https://www.510kdatabase.net/k182328/ 2019-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k182328-vericlear-digital-early-result-fda-510k.jpg K182328 - VeriClear Digital Early Result Pregnancy Test K182328 is a FDA 510(k) cleared chemistry medical device. Manufacturer: True Diagnostics, Inc.. Cleared May 2019. https://www.510kdatabase.net/k182408/ 2019-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k182408-single-use-electrosurgical-knife-kd-fda-510k.jpg K182408 - Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645 K182408 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared May 2019. https://www.510kdatabase.net/k182520/ 2019-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k182520-flexible-overtube-fda-510k.jpg K182520 - Flexible Overtube K182520 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Sumitomo Bakelite Co., Ltd.. Cleared May 2019. https://www.510kdatabase.net/k182532/ 2019-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k182532-liba3-system-fda-510k.jpg K182532 - Liba3 System K182532 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: National Cardiac, Inc.. Cleared May 2019. https://www.510kdatabase.net/k182602/ 2019-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k182602-sofia-ex-intracranial-support-catheter-fda-510k.jpg K182602 - SOFIA EX Intracranial Support Catheter K182602 is a FDA 510(k) cleared neurology medical device. Manufacturer: MicroVention, Inc.. Cleared May 2019. https://www.510kdatabase.net/k183277/ 2019-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k183277-spo2-sensor-fda-510k.jpg K183277 - SpO2 Sensor K183277 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Upnmed Equipment Co., Ltd.. Cleared May 2019. https://www.510kdatabase.net/k183292/ 2019-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k183292-topaz-mobile-dr-system-fda-510k.jpg K183292 - Topaz Mobile DR System K183292 is a FDA 510(k) cleared radiology medical device. Manufacturer: DRGEM Corporation. Cleared May 2019. https://www.510kdatabase.net/k183648/ 2019-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k183648-apas-independence-with-urine-analysis-fda-510k.jpg K183648 - APAS Independence with Urine Analysis Module K183648 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Clever Culture Systems AG. Cleared May 2019. https://www.510kdatabase.net/k183697/ 2019-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k183697-masimo-rad-97-and-accessories-fda-510k.jpg K183697 - Masimo Rad-97 and Accessories K183697 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Masimo Corporation. Cleared May 2019. https://www.510kdatabase.net/k190034/ 2019-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k190034-remy-medical-therapy-laser-system-fda-510k.jpg K190034 - REMY Medical Therapy Laser System K190034 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Footdocprenur, LLC. Cleared May 2019. https://www.510kdatabase.net/k190405/ 2019-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k190405-bactalert-mp-reagent-system-fda-510k.jpg K190405 - BACT/ALERT MP Reagent System K190405 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared May 2019. https://www.510kdatabase.net/k190493/ 2019-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k190493-recovery-pump-737r-rpx-fda-510k.jpg K190493 - Recovery Pump, 737R (RPX) K190493 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Mego Afek AC , Ltd.. Cleared May 2019. https://www.510kdatabase.net/k190584/ 2019-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k190584-cayman-lp-plate-system-fda-510k.jpg K190584 - CAYMAN LP Plate System K190584 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: K2m, Inc.. Cleared May 2019. https://www.510kdatabase.net/k190639/ 2019-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k190639-endosee-system-fda-510k.jpg K190639 - Endosee System K190639 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: CooperSurgical, Inc.. Cleared May 2019. https://www.510kdatabase.net/k181419/ 2019-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k181419-flix-ems-fda-510k.jpg K181419 - FLIX-EMS K181419 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Casgarum Investment, S.L.. Cleared May 2019. https://www.510kdatabase.net/k190069/ 2019-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k190069-sixfix-hexapod-fixator-and-deformity-fda-510k.jpg K190069 - SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) K190069 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arrowhead De, LLC. Cleared May 2019. https://www.510kdatabase.net/k190297/ 2019-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k190297-celerity-hp-incubator-fda-510k.jpg K190297 - Celerity HP Incubator K190297 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared May 2019. https://www.510kdatabase.net/k190315/ 2019-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k190315-immunocap-allergen-e229-allergen-fda-510k.jpg K190315 - ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e230, Allergen Component rCan f 6 Dog, ImmunoCAP Allergen e231, Allergen Component rFel d 7 Cat K190315 is a FDA 510(k) cleared immunology medical device. Manufacturer: Phadia AB. Cleared May 2019. https://www.510kdatabase.net/k190670/ 2019-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k190670-ortholoc-2-lapidus-with-rotation-system-fda-510k.jpg K190670 - ORTHOLOC™ 2 Lapidus with Rotation System K190670 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared May 2019. https://www.510kdatabase.net/k190848/ 2019-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k190848-jusha-m550g-jusha-m550m550gm550-lcd-fda-510k.jpg K190848 - JUSHA-M550G/ JUSHA-M550/M550G/M550 LCD Monitor K190848 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nanjing Jusha Display Technology Co., Ltd.. Cleared May 2019. https://www.510kdatabase.net/k190974/ 2019-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k190974-dvill-introducer-fda-510k.jpg K190974 - D'Vill Introducer K190974 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: NuMED, Inc.. Cleared May 2019. https://www.510kdatabase.net/k190985/ 2019-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k190985-baronova-insufflation-system-baronova-fda-510k.jpg K190985 - BAROnova Insufflation System, BAROnova Accessory Kit K190985 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baronova, Inc.. Cleared May 2019. https://www.510kdatabase.net/k183109/ 2019-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k183109-controlrad-trace-model-8-fda-510k.jpg K183109 - ControlRad Trace Model 8 K183109 is a FDA 510(k) cleared radiology medical device. Manufacturer: Controlrad, Inc.. Cleared May 2019. https://www.510kdatabase.net/k190170/ 2019-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k190170-mvp-cervical-plate-system-fda-510k.jpg K190170 - MVP Cervical Plate System K190170 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: GS Medical Co., Ltd.. Cleared May 2019. https://www.510kdatabase.net/k190219/ 2019-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k190219-simplexa-vzv-direct-simplexa-vzv-fda-510k.jpg K190219 - Simplexa VZV Direct, Simplexa VZV Positive Control Pack K190219 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Diasorin Molecular, LLC. Cleared May 2019. https://www.510kdatabase.net/k190604/ 2019-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k190604-pivo-fda-510k.jpg K190604 - PIVO K190604 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Velano Vascular. Cleared May 2019. https://www.510kdatabase.net/k190764/ 2019-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k190764-surgicalar-fda-510k.jpg K190764 - SurgicalAR K190764 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medivis, Inc.. Cleared May 2019. https://www.510kdatabase.net/k183515/ 2019-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k183515-mr8-drill-system-midas-rex-mr8-fda-510k.jpg K183515 - MR8 Drill System, Midas Rex MR8 ClearView Tools K183515 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Powered Surgical Solutions. Cleared May 2019. https://www.510kdatabase.net/k182180/ 2019-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k182180-speac-system-fda-510k.jpg K182180 - SPEAC System K182180 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brain Sentinel, Inc.. Cleared May 2019. https://www.510kdatabase.net/k181545/ 2019-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k181545-hysteroscope-system-fda-510k.jpg K181545 - Hysteroscope System K181545 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shanghai AnQing Medical Instrument Co., Ltd.. Cleared May 2019. https://www.510kdatabase.net/k182612/ 2019-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k182612-powder-free-nitrile-examination-gloves-fda-510k.jpg K182612 - Powder Free Nitrile Examination Gloves (Cobalt Blue, Black, Blue and Violet Blue) K182612 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zibo Yahao Supplies Co., Ltd.. Cleared May 2019. https://www.510kdatabase.net/k182959/ 2019-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k182959-wallace-dual-lumen-oocyte-recovery-fda-510k.jpg K182959 - Wallace Dual Lumen Oocyte Recovery System K182959 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: CooperSurgical, Inc.. Cleared May 2019. https://www.510kdatabase.net/k183319/ 2019-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k183319-triangle-system-fda-510k.jpg K183319 - Triangle System K183319 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: AliveCor, Inc.. Cleared May 2019. https://www.510kdatabase.net/k183583/ 2019-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k183583-vanguard-complete-knee-system-fda-510k.jpg K183583 - Vanguard Complete Knee System K183583 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared May 2019. https://www.510kdatabase.net/k190027/ 2019-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k190027-steristay-fda-510k.jpg K190027 - SteriStay K190027 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Toul Meditech AB. Cleared May 2019. https://www.510kdatabase.net/k190173/ 2019-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k190173-ergoline-inspiration-550-hybrid-fda-510k.jpg K190173 - Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / Sound K190173 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Jk Holding GmbH. Cleared May 2019. https://www.510kdatabase.net/k190275/ 2019-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k190275-genepoc-carba-fda-510k.jpg K190275 - GenePOC Carba K190275 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Genepoc, Inc.. Cleared May 2019. https://www.510kdatabase.net/k190854/ 2019-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k190854-therm-x-fda-510k.jpg K190854 - Therm-X K190854 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zenith Technical Innovations. Cleared May 2019. https://www.510kdatabase.net/k190989/ 2019-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k190989-6400-ultrasound-system-mylabx6-mylabx7-fda-510k.jpg K190989 - 6400 Ultrasound System (MyLabX6, MyLabX7) K190989 is a FDA 510(k) cleared radiology medical device. Manufacturer: Esaote, S.P.A.. Cleared May 2019. https://www.510kdatabase.net/k190995/ 2019-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k190995-exactvu-high-resolution-micro-fda-510k.jpg K190995 - ExactVu High Resolution Micro-Ultrasound System K190995 is a FDA 510(k) cleared radiology medical device. Manufacturer: Exact Imaging, Inc.. Cleared May 2019. https://www.510kdatabase.net/k191046/ 2019-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k191046-l10-led-light-source-with-aim-l11-led-fda-510k.jpg K191046 - L10 LED Light Source with AIM, L11 LED Light Source with AIM K191046 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker. Cleared May 2019. https://www.510kdatabase.net/k181491/ 2019-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k181491-delta-dual-mobility-system-fda-510k.jpg K181491 - Delta Dual Mobility System K181491 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Lima Corporate S.P.A.. Cleared May 2019. https://www.510kdatabase.net/k181894/ 2019-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k181894-tof-cuff-monitor-fda-510k.jpg K181894 - TOF-Cuff monitor K181894 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Rgb Medical Devices SA. Cleared May 2019. https://www.510kdatabase.net/k181933/ 2019-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k181933-depuy-synthes-sterilization-container-fda-510k.jpg K181933 - DePuy Synthes Sterilization Container System K181933 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.. Cleared May 2019. https://www.510kdatabase.net/k182617/ 2019-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k182617-atec-iom-accessory-instruments-fda-510k.jpg K182617 - ATEC IOM Accessory Instruments K182617 is a FDA 510(k) cleared neurology medical device. Manufacturer: Alphatec Spine, Inc.. Cleared May 2019. https://www.510kdatabase.net/k183160/ 2019-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k183160-teg-6s-hemostasis-system-teg-6s-fda-510k.jpg K183160 - TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge K183160 is a FDA 510(k) cleared hematology medical device. Manufacturer: Haemonetics Corporation. Cleared May 2019. https://www.510kdatabase.net/k183310/ 2019-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k183310-encore-system-fda-510k.jpg K183310 - Encore System K183310 is a FDA 510(k) cleared dental medical device. Manufacturer: Siesta Medical, Inc.. Cleared May 2019. https://www.510kdatabase.net/k190218/ 2019-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k190218-unscented-menstrual-tampon-fda-510k.jpg K190218 - Unscented Menstrual Tampon K190218 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Qingdao Youjia Hygiene Technology Co., Ltd.. Cleared May 2019. https://www.510kdatabase.net/k190393/ 2019-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k190393-wingman-14c-crossing-catheter-fda-510k.jpg K190393 - Wingman 14C Crossing Catheter K190393 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Reflow Medical, Inc.. Cleared May 2019. https://www.510kdatabase.net/k190666/ 2019-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k190666-cygnus-anterior-cervical-plate-system-fda-510k.jpg K190666 - CYGNUS™ Anterior Cervical Plate System K190666 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: MiRus, LLC. Cleared May 2019. https://www.510kdatabase.net/k190699/ 2019-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k190699-rowheels-revolution-10-fda-510k.jpg K190699 - Rowheels Revolution 1.0 K190699 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Rowheels, Inc.. Cleared May 2019. https://www.510kdatabase.net/k190917/ 2019-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k190917-v-pro-60-a-low-tempurature-fda-510k.jpg K190917 - V-PRO 60 a Low Tempurature Strilization Systems, V-PRO s2 Low Temperature Sterilization Systems K190917 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared May 2019. https://www.510kdatabase.net/k190948/ 2019-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k190948-magic-clear-aligners-fda-510k.jpg K190948 - Magic Clear Aligners K190948 is a FDA 510(k) cleared dental medical device. Manufacturer: Voodoo Manufacturing, Inc.. Cleared May 2019. https://www.510kdatabase.net/k182238/ 2019-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k182238-reprocessed-viewflex-xtra-ice-catheter-fda-510k.jpg K182238 - Reprocessed ViewFlex Xtra ICE Catheter K182238 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Stryker Sustainability Solutions. Cleared May 2019. https://www.510kdatabase.net/k182428/ 2019-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k182428-glucoleader-enhance-blood-glucose-fda-510k.jpg K182428 - GlucoLeader Enhance Blood Glucose Monitoring System K182428 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Hmd Biomedical, Inc.. Cleared May 2019. https://www.510kdatabase.net/k183126/ 2019-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k183126-electrosurgical-accessory-fda-510k.jpg K183126 - Electrosurgical accessory K183126 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: New Deantronics Taiwan , Ltd.. Cleared May 2019. https://www.510kdatabase.net/k183443/ 2019-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k183443-somnodent-avant-fda-510k.jpg K183443 - SomnoDent Avant K183443 is a FDA 510(k) cleared dental medical device. Manufacturer: Somnomed, Inc.. Cleared May 2019. https://www.510kdatabase.net/k183461/ 2019-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k183461-rusch-flocath-hydrophilic-intermittent-fda-510k.jpg K183461 - Rusch Flocath Hydrophilic Intermittent Catheter, Rusch MMG Hydrophilic Intermittent Catheter K183461 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Teleflexmedical, Inc.. Cleared May 2019. https://www.510kdatabase.net/k190092/ 2019-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k190092-unid-patient-specific-3d-printed-tlif-fda-510k.jpg K190092 - UNiD Patient specific 3D printed TLIF cage K190092 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medicrea International SA. Cleared May 2019. https://www.510kdatabase.net/k190147/ 2019-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k190147-colosseum-mesh-fda-510k.jpg K190147 - COLOSSEUM Mesh K190147 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared May 2019. https://www.510kdatabase.net/k190187/ 2019-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k190187-gynescope-system-fda-510k.jpg K190187 - Gynescope System K190187 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Illumigyn , Ltd.. Cleared May 2019. https://www.510kdatabase.net/k190223/ 2019-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k190223-cepheid-xpert-ctng-control-panel-fda-510k.jpg K190223 - Cepheid Xpert CT/NG Control Panel K190223 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Microbiologics, Inc.. Cleared May 2019. https://www.510kdatabase.net/k190567/ 2019-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k190567-keyi-spinal-fixation-system-fda-510k.jpg K190567 - KeYi Spinal Fixation System K190567 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Beijing Keyi Medical Device Technology Co., Ltd.. Cleared May 2019. https://www.510kdatabase.net/k181854/ 2019-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k181854-ossbuilder-system-fda-510k.jpg K181854 - OssBuilder System K181854 is a FDA 510(k) cleared dental medical device. Manufacturer: Osstem Implant Co., Ltd.. Cleared May 2019. https://www.510kdatabase.net/k182865/ 2019-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k182865-neodent-instruments-kits-fda-510k.jpg K182865 - Neodent Instruments Kits K182865 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jjgc Industria E Comercio DE Materiais Dentarios S.A.. Cleared May 2019. https://www.510kdatabase.net/k183016/ 2019-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k183016-stericap-mini-needle-fda-510k.jpg K183016 - SteriCap Mini Needle K183016 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ocujet, LLC. Cleared May 2019. https://www.510kdatabase.net/k183432/ 2019-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k183432-cobas-u-601-urinalysis-test-system-fda-510k.jpg K183432 - cobas u 601 urinalysis test system K183432 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared May 2019. https://www.510kdatabase.net/k183512/ 2019-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k183512-moore-park-mask-fda-510k.jpg K183512 - Moore Park Mask K183512 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Resmed, Ltd.. Cleared May 2019. https://www.510kdatabase.net/k183701/ 2019-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k183701-stryker-chestshield-sterilization-tray-fda-510k.jpg K183701 - Stryker ChestShield Sterilization Tray System K183701 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Paragon Medical. Cleared May 2019. https://www.510kdatabase.net/k190161/ 2019-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k190161-ethyl-chloride-medium-jet-stream-ethyl-fda-510k.jpg K190161 - Ethyl Chloride Medium Jet Stream, Ethyl Chloride Fine Pinpoint spray, Ethyl Chloride Mist, Ethyl Chloride Accustream 360* Medium Spray, Ethyl Chloride Accustream 360* Fine Spray K190161 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Gebauer Company. Cleared May 2019. https://www.510kdatabase.net/k190649/ 2019-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k190649-fujifilm-endoscope-model-ec-760s-vl-fda-510k.jpg K190649 - FUJIFILM Endoscope Model EC-760S-V/L K190649 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fujifilm Corporation. Cleared May 2019. https://www.510kdatabase.net/k191011/ 2019-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k191011-scope-protech-fda-510k.jpg K191011 - Scope ProTech K191011 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Meditech Endoscopy, Ltd.. Cleared May 2019. https://www.510kdatabase.net/k182460/ 2019-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k182460-md-6000p-bladder-scanner-fda-510k.jpg K182460 - MD-6000P Bladder Scanner K182460 is a FDA 510(k) cleared radiology medical device. Manufacturer: MEDA Co., Ltd.. Cleared May 2019. https://www.510kdatabase.net/k190159/ 2019-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k190159-showar-medical-exam-glove-green-powder-fda-510k.jpg K190159 - Showa(R) Medical Exam Glove (Green) powder-free, disposable nitrile glove K190159 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Showa Best Glove, Inc.. Cleared May 2019. https://www.510kdatabase.net/k190165/ 2019-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k190165-capstone-control-spinal-system-fda-510k.jpg K190165 - Capstone Control™ Spinal System K190165 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared May 2019. https://www.510kdatabase.net/k190182/ 2019-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k190182-unity-subcutaneous-delivery-system-for-fda-510k.jpg K190182 - Unity Subcutaneous Delivery System for Remodulin K190182 is a FDA 510(k) cleared general hospital medical device. Manufacturer: DEKA Research & Development. Cleared May 2019. https://www.510kdatabase.net/k190362/ 2019-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k190362-healthpnx-fda-510k.jpg K190362 - HealthPNX K190362 is a FDA 510(k) cleared radiology medical device. Manufacturer: Zebra Medical Vision, Ltd.. Cleared May 2019. https://www.510kdatabase.net/k190643/ 2019-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k190643-medline-electrocautery-pencil-fda-510k.jpg K190643 - Medline Electrocautery Pencil K190643 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medline Industries, Inc.. Cleared May 2019. https://www.510kdatabase.net/k190900/ 2019-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k190900-biograph-vision-fda-510k.jpg K190900 - Biograph Vision K190900 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 2019. https://www.510kdatabase.net/k190941/ 2019-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k190941-biocardia-85-f-avance-steerable-fda-510k.jpg K190941 - BioCardia 8.5 F Avance Steerable lntroducer K190941 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biocardia, Inc.. Cleared May 2019. https://www.510kdatabase.net/k182437/ 2019-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k182437-wireless-intelligent-thermometer-fda-510k.jpg K182437 - Wireless Intelligent Thermometer K182437 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen Jumper Medical Equipment Co., Ltd.. Cleared May 2019. https://www.510kdatabase.net/k183577/ 2019-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k183577-medline-quick-clear-wand-fda-510k.jpg K183577 - Medline Quick-Clear Wand K183577 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medline Industries, Inc.. Cleared May 2019. https://www.510kdatabase.net/k180309/ 2019-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k180309-manual-wheelchair-w54-fda-510k.jpg K180309 - Manual Wheelchair W54 K180309 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Jiangsu Jumao Medical Equipment Co., Ltd.. Cleared May 2019. https://www.510kdatabase.net/k182118/ 2019-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k182118-armor-lc-fda-510k.jpg K182118 - armor LC K182118 is a FDA 510(k) cleared dental medical device. Manufacturer: Mavrik Dental Systems, Ltd.. Cleared May 2019. https://www.510kdatabase.net/k182430/ 2019-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k182430-clearfil-majesty-ic-fda-510k.jpg K182430 - CLEARFIL MAJESTY IC K182430 is a FDA 510(k) cleared dental medical device. Manufacturer: Kuraray Noritake Dental, Inc.. Cleared May 2019. https://www.510kdatabase.net/k182877/ 2019-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k182877-half-dome-posterior-lumbar-interbody-fda-510k.jpg K182877 - HALF DOME Posterior Lumbar Interbody System K182877 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Astura Medical, LLC. Cleared May 2019. https://www.510kdatabase.net/k183188/ 2019-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k183188-flexible-sensor-ureterorenoscopes-boa-fda-510k.jpg K183188 - Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF K183188 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Richard Wolf Medical Instruments Corporation. Cleared May 2019. https://www.510kdatabase.net/k190083/ 2019-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k190083-leaf-photocoagulator-fda-510k.jpg K190083 - Leaf Photocoagulator K190083 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Norlase Aps. Cleared May 2019. https://www.510kdatabase.net/k190222/ 2019-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k190222-filmarray-pneumoniapneumoniaplus-control-fda-510k.jpg K190222 - FilmArray Pneumonia/Pneumoniaplus Control K190222 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Maine Molecular Quality Controls, Inc.. Cleared May 2019. https://www.510kdatabase.net/k190266/ 2019-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k190266-neolsd-msms-kit-fda-510k.jpg K190266 - NeoLSD MSMS Kit K190266 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Perkinelmer, Inc.. Cleared May 2019. https://www.510kdatabase.net/k190278/ 2019-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k190278-auragen-123-suction-lipoplasty-system-fda-510k.jpg K190278 - AuraGen 123 Suction Lipoplasty System (A123) K190278 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Auragen Aesthetics, LLC. Cleared May 2019. https://www.510kdatabase.net/k190287/ 2019-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k190287-arthrex-dynanite-pip-hammertoe-implant-fda-510k.jpg K190287 - Arthrex DynaNite® PIP (Hammertoe) Implant K190287 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared May 2019. https://www.510kdatabase.net/k190409/ 2019-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k190409-matrixrib-fixation-system-fda-510k.jpg K190409 - MatrixRIB Fixation System K190409 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Synthes. Cleared May 2019. https://www.510kdatabase.net/k190504/ 2019-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k190504-intracept-intraosseous-nerve-ablation-fda-510k.jpg K190504 - Intracept Intraosseous Nerve Ablation System (RF Probe), Intracept Intraosseous Nerve Ablation System (Access Instruments), Relievant RF Generator K190504 is a FDA 510(k) cleared neurology medical device. Manufacturer: Relievant Medsystems. Cleared May 2019. https://www.510kdatabase.net/k190525/ 2019-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k190525-relieva-ultirra-sinus-balloon-catheter-fda-510k.jpg K190525 - RELIEVA ULTIRRA Sinus Balloon Catheter K190525 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Acclarent, Inc.. Cleared May 2019. https://www.510kdatabase.net/k190532/ 2019-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k190532-trudi-nav-wire-fda-510k.jpg K190532 - TruDi NAV Wire K190532 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Acclarent, Inc.. Cleared May 2019. https://www.510kdatabase.net/k190599/ 2019-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k190599-aptis-medical-distal-radio-ulnar-joint-fda-510k.jpg K190599 - Aptis Medical Distal Radio Ulnar Joint Implant K190599 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aptis Medical, LLC. Cleared May 2019. https://www.510kdatabase.net/k190879/ 2019-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k190879-n-latex-flc-kappa-n-latex-flc-lambda-fda-510k.jpg K190879 - N Latex FLC kappa, N Latex FLC lambda K190879 is a FDA 510(k) cleared immunology medical device. Manufacturer: Siemens Healthcare Diagnostics Products GmbH. Cleared May 2019. https://www.510kdatabase.net/k181671/ 2019-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k181671-cocoon-convective-warming-system-fda-510k.jpg K181671 - Cocoon Convective Warming System K181671 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Care Essentials Pty, Ltd.. Cleared May 2019. https://www.510kdatabase.net/k182474/ 2019-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k182474-alpha-amylase-direct-alpha-amylase-eps-fda-510k.jpg K182474 - alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL K182474 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Biosystems S.A.. Cleared May 2019. https://www.510kdatabase.net/k183199/ 2019-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k183199-trio-handpiece-fda-510k.jpg K183199 - TRIO Handpiece K183199 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Omniguide, Inc.. Cleared May 2019. https://www.510kdatabase.net/k190233/ 2019-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k190233-k-shield-advantage-port-access-fda-510k.jpg K190233 - K-Shield Advantage Port Access Infusion Set (PAIS) K190233 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Kawasumi Laboratories, Inc.. Cleared May 2019. https://www.510kdatabase.net/k190376/ 2019-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k190376-pass-lp-spinal-system-fda-510k.jpg K190376 - PASS LP Spinal System K190376 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medicrea International SA. Cleared May 2019. https://www.510kdatabase.net/k190540/ 2019-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k190540-ponto-4-fda-510k.jpg K190540 - Ponto 4 K190540 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Oticon Medical AB. Cleared May 2019. https://www.510kdatabase.net/k190560/ 2019-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k190560-sensmart-model-8006ca-reusable-fda-510k.jpg K190560 - SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI Disposable Patient Interface K190560 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Nonin Medical, Inc.. Cleared May 2019. https://www.510kdatabase.net/k190851/ 2019-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k190851-hydrashift-24-daratumumab-fda-510k.jpg K190851 - HYDRASHIFT 2/4 daratumumab K190851 is a FDA 510(k) cleared immunology medical device. Manufacturer: Sebia. Cleared May 2019. https://www.510kdatabase.net/k180510/ 2019-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k180510-ns-120p-trs-airway-pressure-gauge-fda-510k.jpg K180510 - NS 120P-TRS Airway Pressure Gauge K180510 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Instrumentation Industries, Inc.. Cleared May 2019. https://www.510kdatabase.net/k182231/ 2019-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k182231-brush-biopsy-set-fda-510k.jpg K182231 - Brush Biopsy Set K182231 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared May 2019. https://www.510kdatabase.net/k182646/ 2019-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k182646-vitreq-disposable-laser-probes-light-fda-510k.jpg K182646 - Vitreq disposable laser probes, light fibers and Chandelier K182646 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Vitreq BV. Cleared May 2019. https://www.510kdatabase.net/k183394/ 2019-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k183394-carescape-respiratory-modules-e-sco-e-fda-510k.jpg K183394 - CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO K183394 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: GE Healthcare Finland Oy. Cleared May 2019. https://www.510kdatabase.net/k183413/ 2019-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k183413-truwave-disposable-pressure-transducer-fda-510k.jpg K183413 - TruWave Disposable Pressure Transducer K183413 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifeciences, LLC. Cleared May 2019. https://www.510kdatabase.net/k190154/ 2019-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k190154-etest-piperacillintazobactam-pt-00164-fda-510k.jpg K190154 - ETEST Piperacillin/Tazobactam (P/T) (0.016/4-256/4 ug/mL) K190154 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Biomerieux S.A.. Cleared May 2019. https://www.510kdatabase.net/k190227/ 2019-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k190227-boomerang-anterior-cervical-plate-system-fda-510k.jpg K190227 - Boomerang™ Anterior Cervical Plate System K190227 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Choicespine, LP. Cleared May 2019. https://www.510kdatabase.net/k190551/ 2019-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k190551-vaserlipo-system-fda-510k.jpg K190551 - VASERlipo System K190551 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Solta Medical. Cleared May 2019. https://www.510kdatabase.net/k190555/ 2019-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k190555-powerx-lipo-system-fda-510k.jpg K190555 - PowerX Lipo System K190555 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Solta Medical. Cleared May 2019. https://www.510kdatabase.net/k190817/ 2019-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k190817-hs-fiber-fda-510k.jpg K190817 - HS Fiber K190817 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Riverpoint Medical. Cleared May 2019. https://www.510kdatabase.net/k190843/ 2019-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k190843-synchro2-support-guidewire-fda-510k.jpg K190843 - Synchro2 Support Guidewire K190843 is a FDA 510(k) cleared neurology medical device. Manufacturer: Stryker. Cleared May 2019. https://www.510kdatabase.net/k182092/ 2019-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k182092-bd-intelliport-system-fda-510k.jpg K182092 - BD Intelliport System K182092 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson and Company. Cleared Apr 2019. https://www.510kdatabase.net/k182888/ 2019-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k182888-mrcat-pelvis-fda-510k.jpg K182888 - MRCAT Pelvis K182888 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems MR Finland. Cleared Apr 2019. https://www.510kdatabase.net/k183045/ 2019-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k183045-eclipse-2l-fda-510k.jpg K183045 - Eclipse 2L K183045 is a FDA 510(k) cleared neurology medical device. Manufacturer: Balt USA, LLC. Cleared Apr 2019. https://www.510kdatabase.net/k183342/ 2019-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k183342-sambascrew-3d-si-fusion-system-fda-510k.jpg K183342 - SambaScrew 3D SI Fusion System K183342 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthofix, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k183540/ 2019-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k183540-oralenteral-syringes-with-enfit-fda-510k.jpg K183540 - Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL) K183540 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Neomed, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k190114/ 2019-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k190114-flexi-seal-protect-plus-fecal-fda-510k.jpg K190114 - Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector) K190114 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Convatec Limited. Cleared Apr 2019. https://www.510kdatabase.net/k190305/ 2019-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k190305-additive-cap-fda-510k.jpg K190305 - Additive Cap K190305 is a FDA 510(k) cleared general hospital medical device. Manufacturer: International Medical Industries, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k190825/ 2019-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k190825-medtronic-model-5392-external-pulse-fda-510k.jpg K190825 - Medtronic Model 5392 External Pulse Generator (EPG) K190825 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k190866/ 2019-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k190866-xmaruview-v1-xmaru-chiroview-xmaru-fda-510k.jpg K190866 - XmaruView V1 (Xmaru Chiroview, Xmaru Podview) K190866 is a FDA 510(k) cleared radiology medical device. Manufacturer: Rayence Co., Ltd.. Cleared Apr 2019. https://www.510kdatabase.net/k190894/ 2019-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k190894-totim-patient-cushion-immobilization-fda-510k.jpg K190894 - TOTIM Patient Cushion Immobilization System K190894 is a FDA 510(k) cleared radiology medical device. Manufacturer: Essebi Medical Srl. Cleared Apr 2019. https://www.510kdatabase.net/k182017/ 2019-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k182017-compex-hd-fda-510k.jpg K182017 - Compex HD K182017 is a FDA 510(k) cleared dental medical device. Manufacturer: Addent, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k182840/ 2019-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k182840-element-pediatric-wheelchair-fda-510k.jpg K182840 - Element Pediatric Wheelchair K182840 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Leggero, LLC. Cleared Apr 2019. https://www.510kdatabase.net/k190006/ 2019-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k190006-magnetic-surgical-system-fda-510k.jpg K190006 - Magnetic Surgical System K190006 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Levita Magnetics International Corp. Cleared Apr 2019. https://www.510kdatabase.net/k190553/ 2019-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k190553-hardychrom-cre-fda-510k.jpg K190553 - HardyCHROM CRE K190553 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Hardy Diagnostics. Cleared Apr 2019. https://www.510kdatabase.net/k190592/ 2019-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k190592-yelloport-elite-port-access-system-fda-510k.jpg K190592 - YelloPort Elite Port Access System K190592 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Surgical Innovations Limited. Cleared Apr 2019. https://www.510kdatabase.net/k190619/ 2019-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k190619-aspirontm-aspiration-catheter-fda-510k.jpg K190619 - Aspiron(TM) Aspiration Catheter K190619 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Meril Life Sciences Private Limited. Cleared Apr 2019. https://www.510kdatabase.net/k190627/ 2019-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k190627-valo-grand-corded-fda-510k.jpg K190627 - VALO Grand Corded K190627 is a FDA 510(k) cleared dental medical device. Manufacturer: Ultradent Products, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k190655/ 2019-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k190655-seaspine-shoreline-acs-anterior-fda-510k.jpg K190655 - SeaSpine® Shoreline™ ACS- Anterior Cervical Standalone System K190655 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared Apr 2019. https://www.510kdatabase.net/k190965/ 2019-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k190965-myday-fda-510k.jpg K190965 - MyDay K190965 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: CooperVision, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k181732/ 2019-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k181732-interspace-knee-extra-large-size-fda-510k.jpg K181732 - InterSpace Knee Extra-Large Size, InterSpace Knee ATS K181732 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tecres S.P.A.. Cleared Apr 2019. https://www.510kdatabase.net/k182108/ 2019-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k182108-portable-electro-stimulation-therapy-fda-510k.jpg K182108 - Portable Electro-Stimulation Therapy Device K182108 is a FDA 510(k) cleared neurology medical device. Manufacturer: Guangzhou Longest Science & Technology Co., Ltd.. Cleared Apr 2019. https://www.510kdatabase.net/k182585/ 2019-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k182585-jo-actively-trying-personal-lubricant-fda-510k.jpg K182585 - JO Actively Trying Personal Lubricant K182585 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: United Consortium. Cleared Apr 2019. https://www.510kdatabase.net/k182637/ 2019-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k182637-philips-intellivue-xds-software-fda-510k.jpg K182637 - Philips IntelliVue XDS Software K182637 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Philips Medizin Systeme Boeblingen GmbH. Cleared Apr 2019. https://www.510kdatabase.net/k182830/ 2019-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k182830-cardinal-healthtm-poly-coated-open-fda-510k.jpg K182830 - Cardinal HealthTM Poly-Coated Open-Back Protective Gown K182830 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cardinal Health200, LLC. Cleared Apr 2019. https://www.510kdatabase.net/k183094/ 2019-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k183094-cyclaplex-correction-system-fda-510k.jpg K183094 - CyclaPlex Correction System K183094 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Cycla Orthopedics, Ltd.. Cleared Apr 2019. https://www.510kdatabase.net/k190290/ 2019-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k190290-altivate-reverse-humeral-stem-48mm-fda-510k.jpg K190290 - AltiVate Reverse Humeral Stem, 48mm K190290 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Encore Medical, L.P.. Cleared Apr 2019. https://www.510kdatabase.net/k190464/ 2019-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k190464-penumbra-system-3d-revascularization-fda-510k.jpg K190464 - Penumbra System 3D Revascularization Device K190464 is a FDA 510(k) cleared neurology medical device. Manufacturer: Penumbra, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k190807/ 2019-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k190807-vitros-xt-chemistry-products-tbil-alkp-fda-510k.jpg K190807 - VITROS XT Chemistry Products TBIL-ALKP Slides K190807 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Ortho-Clinical Diagnostics, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k181787/ 2019-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k181787-cediflo-enteral-feeding-tubes-cediflo-fda-510k.jpg K181787 - Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes K181787 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cedic S.R.L.. Cleared Apr 2019. https://www.510kdatabase.net/k182049/ 2019-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k182049-excellerator-cervical-collection-device-fda-510k.jpg K182049 - exCellerator Cervical Collection Device K182049 is a FDA 510(k) cleared pathology medical device. Manufacturer: Excell Company, LLC. Cleared Apr 2019. https://www.510kdatabase.net/k182071/ 2019-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k182071-multi-sideport-catheter-infusion-set-fda-510k.jpg K182071 - Multi-Sideport Catheter Infusion Set K182071 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Apr 2019. https://www.510kdatabase.net/k182100/ 2019-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k182100-smile-makers-personal-lubricant-fda-510k.jpg K182100 - Smile Makers Personal Lubricant K182100 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Lfbeauty (Thailand) Limited. Cleared Apr 2019. https://www.510kdatabase.net/k183146/ 2019-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k183146-ranfac-cartilage-biopsy-needle-fda-510k.jpg K183146 - Ranfac Cartilage Biopsy Needle K183146 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ranfac Corporation. Cleared Apr 2019. https://www.510kdatabase.net/k183248/ 2019-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k183248-synapse-enterprise-viewer-version-10-fda-510k.jpg K183248 - Synapse Enterprise Viewer Version 1.0 K183248 is a FDA 510(k) cleared radiology medical device. Manufacturer: Fujifilm Corporation. Cleared Apr 2019. https://www.510kdatabase.net/k183537/ 2019-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k183537-panavia-sa-cement-universal-fda-510k.jpg K183537 - PANAVIA SA Cement Universal K183537 is a FDA 510(k) cleared dental medical device. Manufacturer: Kuraray Noritake Dental, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k190042/ 2019-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k190042-brainlab-elements-image-fusion-angio-fda-510k.jpg K190042 - Brainlab Elements Image Fusion Angio K190042 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab AG. Cleared Apr 2019. https://www.510kdatabase.net/k190601/ 2019-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k190601-masterad-mx30-fda-510k.jpg K190601 - MasteRad MX30 K190601 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medicatech USA. Cleared Apr 2019. https://www.510kdatabase.net/k190771/ 2019-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k190771-xpert-mrsasa-blood-culture-genexpert-fda-510k.jpg K190771 - Xpert MRSA/SA Blood Culture, GeneXpert Dx System, GeneXpert Infinity-48s System, GeneXpert Infinity-80 System K190771 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Cepheid. Cleared Apr 2019. https://www.510kdatabase.net/k173065/ 2019-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k173065-ad-medical-blood-pressure-monitors-fda-510k.jpg K173065 - A&D Medical Blood Pressure Monitors K173065 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: A&D Company, Ltd.. Cleared Apr 2019. https://www.510kdatabase.net/k182172/ 2019-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k182172-medline-level-4-surgical-gown-sirus-fda-510k.jpg K182172 - Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora) K182172 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k183156/ 2019-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k183156-v-laser-fda-510k.jpg K183156 - V-Laser K183156 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wontech Co., Ltd.. Cleared Apr 2019. https://www.510kdatabase.net/k183679/ 2019-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k183679-occlusion-balloon-catheter-fda-510k.jpg K183679 - Occlusion Balloon Catheter K183679 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Qxmedical, LLC. Cleared Apr 2019. https://www.510kdatabase.net/k190043/ 2019-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k190043-halley-resin-fda-510k.jpg K190043 - Halley resin K190043 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona. Cleared Apr 2019. https://www.510kdatabase.net/k190113/ 2019-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k190113-veloxion-controller-kit-veloxion-fluid-fda-510k.jpg K190113 - Veloxion Controller Kit, Veloxion Fluid Control Set, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch, Waste Management Bags K190113 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Corinth Medtech, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k190212/ 2019-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k190212-axs-vecta-aspiration-system-fda-510k.jpg K190212 - AXS Vecta Aspiration System K190212 is a FDA 510(k) cleared neurology medical device. Manufacturer: Stryker Neurovascular. Cleared Apr 2019. https://www.510kdatabase.net/k190375/ 2019-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k190375-parcus-atlas-fda-510k.jpg K190375 - Parcus ATLAS K190375 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Parcus Medical, LLC. Cleared Apr 2019. https://www.510kdatabase.net/k190496/ 2019-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k190496-hyperion-x9-pro-newtom-giano-hr-x-fda-510k.jpg K190496 - hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS K190496 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cefla S.C.. Cleared Apr 2019. https://www.510kdatabase.net/k190789/ 2019-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k190789-intellicarttm-system-fda-510k.jpg K190789 - IntelliCartTM System K190789 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Dornoch Medical Systems. Cleared Apr 2019. https://www.510kdatabase.net/k190812/ 2019-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k190812-rayscan-a-expert3d-fda-510k.jpg K190812 - RAYSCAN a-Expert3D K190812 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ray Co., Ltd.. Cleared Apr 2019. https://www.510kdatabase.net/den170064/ 2019-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/den170064-comaneci-comaneci-petit-comaneci-17-fda-510k.jpg DEN170064 - Comaneci, Comaneci Petit, Comaneci 17 DEN170064 is a FDA 510(k) cleared neurology medical device. Manufacturer: Rapid Medical , Ltd.. Cleared Apr 2019. https://www.510kdatabase.net/k181472/ 2019-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k181472-aeroflextm-automatic-endoscope-fda-510k.jpg K181472 - AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor K181472 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Advanced Sterilization Products (Asp). Cleared Apr 2019. https://www.510kdatabase.net/k181971/ 2019-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k181971-bander-ureteral-diversion-stent-set-fda-510k.jpg K181971 - Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set K181971 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Apr 2019. https://www.510kdatabase.net/k182386/ 2019-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k182386-reprocessed-supreme-diagnostic-fda-510k.jpg K182386 - Reprocessed Supreme Diagnostic Electrophysiology Catheter K182386 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Innovative Health, LLC. Cleared Apr 2019. https://www.510kdatabase.net/k182723/ 2019-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k182723-flexible-hd-cysto-urethroscope-system-fda-510k.jpg K182723 - Flexible HD Cysto-Urethroscope System K182723 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k190110/ 2019-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k190110-nanobone-sbx-putty-nanobone-qd-fda-510k.jpg K190110 - NanoBone SBX PUTTY, NanoBone QD K190110 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Artoss GmbH. Cleared Apr 2019. https://www.510kdatabase.net/k190489/ 2019-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k190489-elcam-stopcocks-and-manifolds-fda-510k.jpg K190489 - Elcam Stopcocks and Manifolds K190489 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Elcam Medical Acal. Cleared Apr 2019. https://www.510kdatabase.net/k190621/ 2019-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k190621-sb-knifeshort-type-sb-knifestandard-fda-510k.jpg K190621 - SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long K190621 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Sumitomo Bakelite Co., Ltd.. Cleared Apr 2019. https://www.510kdatabase.net/k190753/ 2019-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k190753-evercrosstm-0035-otw-pta-dilatation-fda-510k.jpg K190753 - EverCrossTM 0.035 OTW PTA Dilatation Catheter K190753 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc. (Formerly D.B.A. Ev3, Inc. Covidien, LLC.). Cleared Apr 2019. https://www.510kdatabase.net/k182513/ 2019-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k182513-fluchip-8g-influenza-ab-assay-fda-510k.jpg K182513 - FluChip-8G Influenza A+B Assay K182513 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Indevr, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k182516/ 2019-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k182516-comprehensive-nano-stemless-shoulder-fda-510k.jpg K182516 - Comprehensive Nano Stemless Shoulder K182516 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet Manufacturing Corp. Cleared Apr 2019. https://www.510kdatabase.net/k182778/ 2019-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k182778-lc-glossfill-xr-fda-510k.jpg K182778 - LC GLOSSFILL XR K182778 is a FDA 510(k) cleared dental medical device. Manufacturer: S&C Polymer Silicon- Und Composite Spezialitaeten GmbH. Cleared Apr 2019. https://www.510kdatabase.net/k183613/ 2019-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k183613-exgraft-exgraft-carbon-fda-510k.jpg K183613 - exGraft, exGraft Carbon K183613 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Peca Labs. Cleared Apr 2019. https://www.510kdatabase.net/k190407/ 2019-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k190407-cryolab-fda-510k.jpg K190407 - CryoLab K190407 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cryoconcepts LP. Cleared Apr 2019. https://www.510kdatabase.net/k180065/ 2019-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k180065-fusion-plus-curing-light-fda-510k.jpg K180065 - FUSION Plus Curing Light K180065 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentlight, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k181571/ 2019-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k181571-oasys-oralnasal-airway-system-and-fda-510k.jpg K181571 - OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor K181571 is a FDA 510(k) cleared dental medical device. Manufacturer: Mark Abramson, D.D.S., Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k183056/ 2019-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k183056-assure-anterior-cervical-plate-system-fda-510k.jpg K183056 - ASSURE® Anterior Cervical Plate System K183056 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k183090/ 2019-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k183090-relieva-tract-balloon-dilation-system-fda-510k.jpg K183090 - Relieva Tract Balloon Dilation System K183090 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Acclarent, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k183192/ 2019-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k183192-capsocam-plus-sv-3-fda-510k.jpg K183192 - CapsoCam Plus (SV-3) K183192 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: CapsoVision, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k190415/ 2019-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k190415-atlas-plating-system-fda-510k.jpg K190415 - ATLAS Plating System K190415 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: MiRus, LLC. Cleared Apr 2019. https://www.510kdatabase.net/k190463/ 2019-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k190463-cepheid-xpert-c-difficileepi-control-fda-510k.jpg K190463 - Cepheid Xpert C. difficile/Epi Control Panel K190463 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Microbiologics, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k190729/ 2019-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k190729-spy-portable-handheld-imaging-spy-phi-fda-510k.jpg K190729 - SPY Portable Handheld Imaging (SPY-PHI) System K190729 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Novadaq Technologies Ulc. (Now A Part of Stryker). Cleared Apr 2019. https://www.510kdatabase.net/k190791/ 2019-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k190791-ez3d-ie3-fda-510k.jpg K190791 - Ez3D-i/E3 K190791 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ewoosoft Co., Ltd.. Cleared Apr 2019. https://www.510kdatabase.net/den180013/ 2019-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/den180013-prevena-125-and-prevena-plus-125-fda-510k.jpg DEN180013 - PREVENA 125 and PREVENA PLUS 125 Therapy Units DEN180013 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Kci USA, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/den180041/ 2019-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/den180041-monarch-etns-system-fda-510k.jpg DEN180041 - Monarch eTNS System DEN180041 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neurosigma, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k181747/ 2019-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k181747-orthodontic-appliance-fda-510k.jpg K181747 - Orthodontic Appliance K181747 is a FDA 510(k) cleared dental medical device. Manufacturer: Shandong Huge Dental Material Corporation. Cleared Apr 2019. https://www.510kdatabase.net/k182103/ 2019-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k182103-psychemedics-microplate-eia-for-fda-510k.jpg K182103 - Psychemedics Microplate EIA for Fentanyl in Hair K182103 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Psychemedics Corporation. Cleared Apr 2019. https://www.510kdatabase.net/k182457/ 2019-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k182457-hi-torque-vektor-014-195cm-str-hi-fda-510k.jpg K182457 - Hi-Torque Vektor, .014, 195cm, Str, Hi-Torque Vektor, .014, 195cm, J, Hi-Torque Vektor, .014, 300cm, Str, Hi-Torque Vektor, .014, 300cm, J K182457 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Brivant Limited (Lake Region Medical). Cleared Apr 2019. https://www.510kdatabase.net/k183593/ 2019-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k183593-lung-vision-system-fda-510k.jpg K183593 - Lung Vision System K183593 is a FDA 510(k) cleared radiology medical device. Manufacturer: Bodyvision Medical , Ltd.. Cleared Apr 2019. https://www.510kdatabase.net/k183601/ 2019-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k183601-cryotouch-fda-510k.jpg K183601 - CryoTouch K183601 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cryoconcepts LP. Cleared Apr 2019. https://www.510kdatabase.net/k190109/ 2019-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k190109-microscan-dried-gram-negative-miccombo-fda-510k.jpg K190109 - MicroScan Dried Gram Negative MIC/Combo Panels with Eravacycline (ERV) (0.016-32 ug/mL) K190109 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k190364/ 2019-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k190364-cancellex-porous-titanium-lumbar-fda-510k.jpg K190364 - CancelleX Porous Titanium Lumbar Interbody Device K190364 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Xenco Medical, LLC. Cleared Apr 2019. https://www.510kdatabase.net/k190506/ 2019-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k190506-neoform-annuloplasty-ring-fda-510k.jpg K190506 - NeoForm Annuloplasty Ring K190506 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Genesee Biomedical, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k190644/ 2019-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k190644-guide-sheath-fda-510k.jpg K190644 - Guide Sheath K190644 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Surmodics,Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k190788/ 2019-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k190788-disposable-standard-clamp-fda-510k.jpg K190788 - Disposable Standard Clamp K190788 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Standard Bariatrics. Cleared Apr 2019. https://www.510kdatabase.net/k181988/ 2019-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k181988-emurmur-id-fda-510k.jpg K181988 - eMurmur ID K181988 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Csd Labs GmbH. Cleared Apr 2019. https://www.510kdatabase.net/k182702/ 2019-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k182702-sekure-creatine-kinase-assay-fda-510k.jpg K182702 - SEKURE Creatine Kinase Assay K182702 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sekisui Diagnostics P.E.I., Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k182944/ 2019-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k182944-dr-amplatz-micro-plug-fda-510k.jpg K182944 - Dr. Amplatz Micro Plug K182944 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ka Medical, LLC. Cleared Apr 2019. https://www.510kdatabase.net/k182998/ 2019-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k182998-andorate-auxiliary-water-connector-fda-510k.jpg K182998 - Andorate Auxiliary Water Connector K182998 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Smartdata Suzhou Co., Ltd.. Cleared Apr 2019. https://www.510kdatabase.net/k183043/ 2019-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k183043-0071-id-mantaray-reperfusion-catheter-fda-510k.jpg K183043 - 0.071” ID MantaRay Reperfusion Catheter, 0.055” ID MantaRay Reperfusion Catheter, 0.045” ID MantaRay Reperfusion Catheter, 0.035” ID MantaRay Reperfusion Catheter K183043 is a FDA 510(k) cleared neurology medical device. Manufacturer: Imperative Care, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k183152/ 2019-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k183152-phoenix-fda-510k.jpg K183152 - Phoenix K183152 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Us Bionics, Inc. (Dba Suitx). Cleared Apr 2019. https://www.510kdatabase.net/k183189/ 2019-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k183189-ultra-otc-facial-toning-system-fda-510k.jpg K183189 - Ultra OTC Facial Toning System K183189 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Micro Current Technology, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k183395/ 2019-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k183395-arthrex-25-mm-tenodesis-screw-fda-510k.jpg K183395 - Arthrex 2.5 mm Tenodesis Screw K183395 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k183403/ 2019-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k183403-jeti-88-peripheral-thrombectomy-system-fda-510k.jpg K183403 - JETi 88 Peripheral Thrombectomy System K183403 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Walk Vascular, LLC. Cleared Apr 2019. https://www.510kdatabase.net/k183584/ 2019-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k183584-jo-h2o-jelly-original-personal-lubricant-fda-510k.jpg K183584 - JO H2O Jelly Original Personal Lubricant K183584 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: United Consortium. Cleared Apr 2019. https://www.510kdatabase.net/k183634/ 2019-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k183634-stasis-monitoring-system-fda-510k.jpg K183634 - Stasis Monitoring System K183634 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Stasis Labs, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k183638/ 2019-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k183638-smartlinx-vitals-plus-patient-fda-510k.jpg K183638 - SmartLinx Vitals Plus Patient Monitoring System K183638 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Capsule Technologie. Cleared Apr 2019. https://www.510kdatabase.net/k190082/ 2019-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k190082-straumann-blx-variobase-abutment-fda-510k.jpg K190082 - Straumann BLX Variobase Abutment K190082 is a FDA 510(k) cleared dental medical device. Manufacturer: Institut Straumann AG. Cleared Apr 2019. https://www.510kdatabase.net/k190088/ 2019-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k190088-quanta-flash-rf-igm-reagents-quanta-fda-510k.jpg K190088 - QUANTA Flash RF IgM Reagents, QUANTA Flash RF IgA Reagents K190088 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k190369/ 2019-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k190369-m-y-sheath-fda-510k.jpg K190369 - M-Y Sheath K190369 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ram Medical Innovations, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k190688/ 2019-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k190688-versacross-steerable-sheath-versacross-fda-510k.jpg K190688 - VersaCross Steerable Sheath, VersaCross Transseptal Dilator K190688 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baylis Medical Company, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k190693/ 2019-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k190693-hem-6410t-zl-wrist-blood-pressure-fda-510k.jpg K190693 - HEM-6410T-ZL Wrist Blood Pressure Monitor K190693 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Omron Healthcare, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k190728/ 2019-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k190728-arthrex-swivelock-anchors-fda-510k.jpg K190728 - Arthrex SwiveLock Anchors K190728 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k181541/ 2019-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k181541-connect-app-for-ihealth-next-ihealth-fda-510k.jpg K181541 - Connect App for iHealth Next, iHealth React Native SDK, iHealth React Native Library SDK, iHealth Library SDK, iHealth Native SDK K181541 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Andon Health Co, Ltd.. Cleared Apr 2019. https://www.510kdatabase.net/k182217/ 2019-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k182217-linear-cutter-staplers-and-loading-fda-510k.jpg K182217 - Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use K182217 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ezisurg (Suzhou) Medical Co., Ltd.. Cleared Apr 2019. https://www.510kdatabase.net/k182246/ 2019-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k182246-mist-ic-fda-510k.jpg K182246 - MIST IC K182246 is a FDA 510(k) cleared dental medical device. Manufacturer: Imagine Milling Technologies, LLC. Cleared Apr 2019. https://www.510kdatabase.net/k182999/ 2019-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k182999-general-cutting-contra-handpiece-fda-510k.jpg K182999 - General Cutting Contra Handpiece K182999 is a FDA 510(k) cleared dental medical device. Manufacturer: Nakanishi, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k183302/ 2019-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k183302-ky-banksy-aloe-fda-510k.jpg K183302 - KY Banksy Aloe K183302 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Rb Health (Us), LLC. Cleared Apr 2019. https://www.510kdatabase.net/k183332/ 2019-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k183332-braxx-esophageal-brachytherapy-fda-510k.jpg K183332 - “BRAXX” Esophageal Brachytherapy Applicator K183332 is a FDA 510(k) cleared radiology medical device. Manufacturer: Braxx Biotech Co., Ltd.. Cleared Apr 2019. https://www.510kdatabase.net/k183428/ 2019-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k183428-avulsion-forceps-fda-510k.jpg K183428 - Avulsion Forceps K183428 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: STERIS Corporation. Cleared Apr 2019. https://www.510kdatabase.net/k183619/ 2019-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k183619-tactra-penile-prosthesis-95-mm-device-fda-510k.jpg K183619 - Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device K183619 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Apr 2019. https://www.510kdatabase.net/k190773/ 2019-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k190773-elecsys-tsh-fda-510k.jpg K190773 - Elecsys TSH K190773 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Apr 2019. https://www.510kdatabase.net/k181673/ 2019-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k181673-rigi10-malleable-penile-prosthesis-fda-510k.jpg K181673 - Rigi10 Malleable Penile Prosthesis K181673 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Rigicon, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k181844/ 2019-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k181844-one-touch-fda-510k.jpg K181844 - One Touch K181844 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Thai Nippon Rubber Industry Public Company, Ltd.. Cleared Apr 2019. https://www.510kdatabase.net/k182272/ 2019-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k182272-reprocessed-harmonic-ace-7-shears-with-fda-510k.jpg K182272 - Reprocessed HARMONIC ACE+ 7 Shears with Advanced Hemostasis K182272 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sterilmed, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k182828/ 2019-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k182828-medline-renewal-reprocessed-carter-fda-510k.jpg K182828 - Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer K182828 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Surgical Instrument Service and Savings, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k182924/ 2019-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k182924-diode-laser-treatment-system-fda-510k.jpg K182924 - Diode Laser Treatment System K182924 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Weifang KM Electronics Co., Ltd.. Cleared Apr 2019. https://www.510kdatabase.net/k183548/ 2019-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k183548-somatom-perspective-somatom-scopescope-fda-510k.jpg K183548 - SOMATOM Perspective, SOMATOM Scope/Scope Power, SOMATOM Emotion 16 K183548 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k190072/ 2019-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k190072-briefcase-fda-510k.jpg K190072 - BriefCase K190072 is a FDA 510(k) cleared radiology medical device. Manufacturer: Aidoc Medical , Ltd.. Cleared Apr 2019. https://www.510kdatabase.net/k190320/ 2019-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k190320-prexion3d-explorer-fda-510k.jpg K190320 - PreXion3D Explorer K190320 is a FDA 510(k) cleared radiology medical device. Manufacturer: Prexion Corporation. Cleared Apr 2019. https://www.510kdatabase.net/k190420/ 2019-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k190420-ndohd-high-definition-imaging-system-fda-510k.jpg K190420 - NDOHD High Definition Imaging System (NDOHD) K190420 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Altaravision, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k190705/ 2019-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k190705-wholepower-pregnancy-rapid-test-fda-510k.jpg K190705 - WHOLEPOWER Pregnancy Rapid Test Cassette, WHOLEPOWER Pregnancy Rapid Test Strip, WHOLEPOWER Pregnancy Rapid Test Midstream K190705 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Wholepower Biotech Co., Ltd.. Cleared Apr 2019. https://www.510kdatabase.net/k190690/ 2019-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k190690-inspire-7-hollow-fiber-oxygenator-with-fda-510k.jpg K190690 - INSPIRE 7 Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir, INSPIRE 7M Hollow Fiber Oxygenator, INSPIRE 7 Dual Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir K190690 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sorin Group Italia S.R.L.. Cleared Apr 2019. https://www.510kdatabase.net/k180757/ 2019-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k180757-d-clip-fda-510k.jpg K180757 - D-Clip K180757 is a FDA 510(k) cleared neurology medical device. Manufacturer: Peter Lazic GmbH. Cleared Apr 2019. https://www.510kdatabase.net/k181912/ 2019-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k181912-ascent-cardiorespiratory-diagnostic-fda-510k.jpg K181912 - Ascent Cardiorespiratory Diagnostic Software K181912 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Medical Graphics Corporation. Cleared Apr 2019. https://www.510kdatabase.net/k181915/ 2019-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k181915-pixotest-poct-system-pixotest-poct-fda-510k.jpg K181915 - PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit K181915 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Ixensor Co, Ltd.. Cleared Apr 2019. https://www.510kdatabase.net/k182396/ 2019-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k182396-kardiamobile-kardiastation-fda-510k.jpg K182396 - KardiaMobile, KardiaStation K182396 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: AliveCor, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k182572/ 2019-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k182572-instarispacs-instazfp-instamobi-v50-fda-510k.jpg K182572 - InstaRISPACS / InstaZFP / InstaMobi v5.0 K182572 is a FDA 510(k) cleared radiology medical device. Manufacturer: Meddiff Technologies Pvt. , Ltd.. Cleared Apr 2019. https://www.510kdatabase.net/k182619/ 2019-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k182619-eplex-blood-culture-identification-fda-510k.jpg K182619 - ePlex Blood Culture Identification Gram Negative (BCID-GN) Panel K182619 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Genmark Diagnostics, Incorporated. Cleared Apr 2019. https://www.510kdatabase.net/k182640/ 2019-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k182640-powder-free-nitrile-examination-gloves-fda-510k.jpg K182640 - Powder Free Nitrile Examination Gloves (White, Cobalt Blue, Blue and Violet Blue) K182640 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shandong Hengya Packaging Printing Co.,Ltd. Cleared Apr 2019. https://www.510kdatabase.net/k182737/ 2019-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k182737-3t-32-channel-head-coil-fda-510k.jpg K182737 - 3T 32 Channel Head Coil K182737 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nova Medical, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k182891/ 2019-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k182891-teecleanr-automated-tee-probe-cleaner-fda-510k.jpg K182891 - TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants K182891 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cs Medical, LLC. Cleared Apr 2019. https://www.510kdatabase.net/k183015/ 2019-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k183015-purasinus-fda-510k.jpg K183015 - PuraSinus K183015 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: 3-D Matrix, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k183202/ 2019-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k183202-deep-learning-image-reconstruction-fda-510k.jpg K183202 - Deep Learning Image Reconstruction K183202 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems, LLC. Cleared Apr 2019. https://www.510kdatabase.net/k183490/ 2019-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k183490-affinity-nt-oxygenator-affinity-nt-fda-510k.jpg K183490 - Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Balance Biosurface K183490 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k183599/ 2019-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k183599-makoto-intravascular-imaging-system-fda-510k.jpg K183599 - Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter K183599 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Infraredx, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k190079/ 2019-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k190079-argenz-ht-fda-510k.jpg K190079 - ArgenZ HT+ K190079 is a FDA 510(k) cleared dental medical device. Manufacturer: The Argen Corporation. Cleared Apr 2019. https://www.510kdatabase.net/k190365/ 2019-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k190365-baby-gorillagorilla-plating-system-fda-510k.jpg K190365 - Baby Gorilla/Gorilla Plating System K190365 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paragon 28, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k190626/ 2019-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k190626-syncvision-system-fda-510k.jpg K190626 - SyncVision System K190626 is a FDA 510(k) cleared radiology medical device. Manufacturer: Volcano Corporation. Cleared Apr 2019. https://www.510kdatabase.net/k190658/ 2019-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k190658-mis-bunion-plating-system-fda-510k.jpg K190658 - MIS Bunion Plating System K190658 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Crossroads Extremity Systems, LLC. Cleared Apr 2019. https://www.510kdatabase.net/k190664/ 2019-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k190664-rt-elements-cranial-srs-spine-srs-fda-510k.jpg K190664 - RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review K190664 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab AG. Cleared Apr 2019. https://www.510kdatabase.net/den180060/ 2019-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/den180060-plenity-fda-510k.jpg DEN180060 - Plenity DEN180060 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Gelesis, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k181296/ 2019-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k181296-syntec-femoral-nail-system-fda-510k.jpg K181296 - Syntec Femoral Nail System K181296 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Syntec Scientific Corporation. Cleared Apr 2019. https://www.510kdatabase.net/k181361/ 2019-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k181361-brux-night-guard-fda-510k.jpg K181361 - Brux Night Guard K181361 is a FDA 510(k) cleared dental medical device. Manufacturer: Brux Night Guard. Cleared Apr 2019. https://www.510kdatabase.net/k181758/ 2019-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k181758-elra-electrode-fda-510k.jpg K181758 - ELRA Electrode K181758 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Starmed Co., Ltd.. Cleared Apr 2019. https://www.510kdatabase.net/k183398/ 2019-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k183398-endoform-restella-fda-510k.jpg K183398 - Endoform Restella K183398 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aroa Biosurgery , Ltd.. Cleared Apr 2019. https://www.510kdatabase.net/k183526/ 2019-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k183526-codman-electrosurgical-generator-foot-fda-510k.jpg K183526 - Codman Electrosurgical Generator, Foot Pedal K183526 is a FDA 510(k) cleared neurology medical device. Manufacturer: Kls Martin GmbH + Co. KG. Cleared Apr 2019. https://www.510kdatabase.net/k190058/ 2019-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k190058-puresleep-otc-use-fda-510k.jpg K190058 - PureSleep (OTC use) K190058 is a FDA 510(k) cleared dental medical device. Manufacturer: Sleep Science Partners, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k190070/ 2019-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k190070-sonopet-iq-ultrasonic-aspirator-system-fda-510k.jpg K190070 - Sonopet iQ Ultrasonic Aspirator System K190070 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker Corporation. Cleared Apr 2019. https://www.510kdatabase.net/k190317/ 2019-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k190317-zavation-spinal-system-fda-510k.jpg K190317 - Zavation Spinal System K190317 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zavation Medical Products, LLC. Cleared Apr 2019. https://www.510kdatabase.net/k190453/ 2019-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k190453-viscalor-bulk-fda-510k.jpg K190453 - VisCalor bulk K190453 is a FDA 510(k) cleared dental medical device. Manufacturer: Voco GmbH. Cleared Apr 2019. https://www.510kdatabase.net/k190786/ 2019-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k190786-eye-prime-fda-510k.jpg K190786 - Eye Prime K190786 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ellex Medical Pty, Ltd.. Cleared Apr 2019. https://www.510kdatabase.net/k181110/ 2019-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k181110-prophyflex-4-fda-510k.jpg K181110 - PROPHYflex 4 K181110 is a FDA 510(k) cleared dental medical device. Manufacturer: Kaltenbach & Voigt GmbH. Cleared Apr 2019. https://www.510kdatabase.net/k182582/ 2019-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k182582-oryum-and-ovem-epidermal-deri-prick-fda-510k.jpg K182582 - Oryum and Ovem Epidermal Deri Prick Test Applicator K182582 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Allergy & Applicator Depot, LLC. Cleared Apr 2019. https://www.510kdatabase.net/k182662/ 2019-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k182662-nav-pak-needle-nim-nav-pak-needle-fda-510k.jpg K182662 - NAV PAK Needle, NIM NAV PAK Needle K182662 is a FDA 510(k) cleared neurology medical device. Manufacturer: Boston Endo Surgical Tech,. Cleared Apr 2019. https://www.510kdatabase.net/k183057/ 2019-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k183057-puma-g-system-fda-510k.jpg K183057 - PUMA-G System K183057 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Coaptech, LLC. Cleared Apr 2019. https://www.510kdatabase.net/k183306/ 2019-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k183306-glucocard-w-onyx-blood-glucose-fda-510k.jpg K183306 - GLUCOCARD® W onyx Blood Glucose Monitoring System K183306 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Arkray Factory, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k190175/ 2019-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k190175-s-mak-xl-fda-510k.jpg K190175 - S-MAK XL K190175 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k190295/ 2019-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k190295-confirm-rx-insertable-cardiac-monitor-fda-510k.jpg K190295 - Confirm Rx Insertable Cardiac Monitor K190295 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott (St. Jude Medical). Cleared Apr 2019. https://www.510kdatabase.net/k190631/ 2019-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k190631-must-mini-posterior-cervical-screws-fda-510k.jpg K190631 - M.U.S.T. MINI Posterior Cervical Screws System K190631 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Apr 2019. https://www.510kdatabase.net/k181832/ 2019-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k181832-transtek-blood-pressure-monitor-fda-510k.jpg K181832 - Transtek Blood Pressure Monitor K181832 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Guangdong Transtek Medical Electronics Co., Ltd.. Cleared Apr 2019. https://www.510kdatabase.net/k182333/ 2019-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k182333-vera-fda-510k.jpg K182333 - Vera K182333 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Reflexion Health, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k182341/ 2019-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k182341-pantheris-sv-fda-510k.jpg K182341 - Pantheris SV K182341 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Avinger, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k182770/ 2019-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k182770-adult-intraosseous-infusion-device-fda-510k.jpg K182770 - Adult Intraosseous Infusion Device K182770 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Einstein Works, LLC. Cleared Apr 2019. https://www.510kdatabase.net/k183660/ 2019-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k183660-dp-10dp-20dp-30-digital-ultrasonic-fda-510k.jpg K183660 - DP-10/DP-20/DP-30 Digital Ultrasonic Diagnostic Imaging System K183660 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Apr 2019. https://www.510kdatabase.net/k190327/ 2019-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k190327-enconnect-40-mm-screw-cap-to-enplus-fda-510k.jpg K190327 - ENConnect 40 mm Screw Cap to ENPlus Adapter K190327 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cedic S.R.L.. Cleared Apr 2019. https://www.510kdatabase.net/k190653/ 2019-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k190653-excelsiusgps-fda-510k.jpg K190653 - ExcelsiusGPS K190653 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k182375/ 2019-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k182375-creo-stabilization-system-navigation-fda-510k.jpg K182375 - CREO® Stabilization System, Navigation Instruments, ExcelsiusGPS® K182375 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k183204/ 2019-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k183204-bone-vcar-bvcar-fda-510k.jpg K183204 - Bone VCAR (BVCAR) K183204 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems SCS. Cleared Apr 2019. https://www.510kdatabase.net/k183496/ 2019-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k183496-jusha-c350g-lcd-monitor-jusha-c350-lcd-fda-510k.jpg K183496 - JUSHA-C350G LCD Monitor, JUSHA-C350 LCD Monitor, C350G LCD Monitor, C350 LCD Monitor K183496 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nanjing Jusha Display Technology Co., Ltd.. Cleared Apr 2019. https://www.510kdatabase.net/k183539/ 2019-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k183539-ergoline-sunrise-7200-hybrid-technology-fda-510k.jpg K183539 - Ergoline Sunrise 7200 Hybrid Technology K183539 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Jk Holding GmbH. Cleared Apr 2019. https://www.510kdatabase.net/k183550/ 2019-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k183550-vitality-spinal-fixation-system-fda-510k.jpg K183550 - Vitality® Spinal Fixation System K183550 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer Biomet Spine, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k183606/ 2019-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k183606-delta4-phantom-mr-pmma-delta4-phantom-fda-510k.jpg K183606 - Delta4 Phantom+ MR (PMMA), Delta4 Phantom+ MR (PW) K183606 is a FDA 510(k) cleared radiology medical device. Manufacturer: Scandidos AB. Cleared Apr 2019. https://www.510kdatabase.net/k183682/ 2019-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k183682-oic-external-fixation-system-fda-510k.jpg K183682 - OIC External Fixation System K183682 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthopaedic Implant Company. Cleared Apr 2019. https://www.510kdatabase.net/k190040/ 2019-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k190040-straumann-blx-line-extension-new-fda-510k.jpg K190040 - Straumann BLX Line Extension - New Abutments K190040 is a FDA 510(k) cleared dental medical device. Manufacturer: Institut Straumann AG. Cleared Apr 2019. https://www.510kdatabase.net/k190611/ 2019-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k190611-vivix-s-1751s-fda-510k.jpg K190611 - VIVIX-S 1751S K190611 is a FDA 510(k) cleared radiology medical device. Manufacturer: Vieworks Co., Ltd.. Cleared Apr 2019. https://www.510kdatabase.net/k182287/ 2019-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k182287-medinaut-plus-fda-510k.jpg K182287 - MEDINAUT Plus K182287 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Imedicom Co., Ltd.. Cleared Apr 2019. https://www.510kdatabase.net/k173770/ 2019-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k173770-ojr215-pressure-relief-manifold-fda-510k.jpg K173770 - OJR215 Pressure Relief Manifold K173770 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Fisher & Paykel Healthcare Limited. Cleared Apr 2019. https://www.510kdatabase.net/k181919/ 2019-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k181919-patient-monitor-fda-510k.jpg K181919 - Patient Monitor K181919 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Guangdong Biolight Meditech Co., Ltd.. Cleared Apr 2019. https://www.510kdatabase.net/k182175/ 2019-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k182175-tcd-x-fda-510k.jpg K182175 - TCD-X K182175 is a FDA 510(k) cleared radiology medical device. Manufacturer: Atys. Cleared Apr 2019. https://www.510kdatabase.net/k182268/ 2019-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k182268-epifaith-syringe-luer-slip-epifaith-fda-510k.jpg K182268 - EpiFaith Syringe (Luer Slip) , EpiFaith Syringe (NRFit) K182268 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Flat Medical Co., Ltd.. Cleared Apr 2019. https://www.510kdatabase.net/k183287/ 2019-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k183287-powder-free-nitrile-patient-fda-510k.jpg K183287 - Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Citrate K183287 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Kossan International Sdn Bhd. Cleared Apr 2019. https://www.510kdatabase.net/k183361/ 2019-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k183361-ekosonic-endovascular-device-with-fda-510k.jpg K183361 - EkoSonic Endovascular Device with Control Unit 4.0 K183361 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Btg International, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k183494/ 2019-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k183494-r190r191-lcd-monitor-fda-510k.jpg K183494 - R190/R191 LCD Monitor K183494 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nanjing Jusha Display Technology Co., Ltd.. Cleared Apr 2019. https://www.510kdatabase.net/k190038/ 2019-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k190038-xbody-newave-usa-fda-510k.jpg K190038 - Xbody Newave USA K190038 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Xbody Hungary Kft.. Cleared Apr 2019. https://www.510kdatabase.net/k190103/ 2019-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k190103-v-pro-max-2-low-temperature-fda-510k.jpg K190103 - V-PRO maX 2 Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 1 Plus Low Temperature Sterilization System, V-PRO 1 Low Temperature Sterilization System K190103 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Apr 2019. https://www.510kdatabase.net/k190581/ 2019-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k190581-amplatzer-trevisio-intravascular-fda-510k.jpg K190581 - Amplatzer Trevisio Intravascular Delivery System K190581 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Medical. Cleared Apr 2019. https://www.510kdatabase.net/k190598/ 2019-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k190598-crossway-spinal-access-system-fda-510k.jpg K190598 - CROSSWAY Spinal Access System K190598 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k173238/ 2019-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k173238-toxco-fda-510k.jpg K173238 - ToxCO K173238 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Bedfont Scientific, Ltd.. Cleared Apr 2019. https://www.510kdatabase.net/k180843/ 2019-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k180843-high-flo-super26-subcutaneous-needle-fda-510k.jpg K180843 - HIgH-Flo Super26 Subcutaneous Needle Sets K180843 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Repro-Med Systems, Inc. Dba Rms Medical Products. Cleared Apr 2019. https://www.510kdatabase.net/k181931/ 2019-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k181931-gmc-upper-arm-automatic-blood-pressure-fda-510k.jpg K181931 - GMC Upper Arm Automatic Blood Pressure Monitor K181931 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Gmc, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k182253/ 2019-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k182253-fujifilm-video-bronchoscopes-fda-510k.jpg K182253 - FUJIFILM Video Bronchoscopes K182253 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Fujifilm Corporation. Cleared Apr 2019. https://www.510kdatabase.net/k182399/ 2019-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k182399-park-blade-septostomy-catheter-fda-510k.jpg K182399 - Park Blade Septostomy Catheter K182399 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Apr 2019. https://www.510kdatabase.net/k182943/ 2019-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k182943-vertex-nitinol-staple-system-fda-510k.jpg K182943 - VERTEX Nitinol Staple System K182943 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nvision Biomedical Technologies, LLC. Cleared Apr 2019. https://www.510kdatabase.net/k183197/ 2019-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k183197-pyramesh-implant-system-fda-510k.jpg K183197 - PYRAMESH™ Implant System K183197 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k183304/ 2019-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k183304-prettau-ice-z-white-zirconia-blanks-fda-510k.jpg K183304 - Prettau, ICE, Z-White zirconia blanks K183304 is a FDA 510(k) cleared dental medical device. Manufacturer: Zirkonzahn Srl. Cleared Apr 2019. https://www.510kdatabase.net/k183377/ 2019-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k183377-dc-40dc-35dc-45dc-40sdc-40-pro-fda-510k.jpg K183377 - DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System K183377 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Apr 2019. https://www.510kdatabase.net/k183445/ 2019-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k183445-erbe-apcapplicators-fda-510k.jpg K183445 - Erbe APCapplicators K183445 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Erbe Elektromedizin GmbH. Cleared Apr 2019. https://www.510kdatabase.net/k190164/ 2019-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k190164-cleverlock-guidewire-locking-device-fda-510k.jpg K190164 - CleverLock Guidewire Locking Device and Biopsy Cap K190164 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Surgical Technologies America. Cleared Apr 2019. https://www.510kdatabase.net/k190416/ 2019-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k190416-dome-electrode-fda-510k.jpg K190416 - Dome Electrode K190416 is a FDA 510(k) cleared neurology medical device. Manufacturer: Coapt, LLC. Cleared Apr 2019. https://www.510kdatabase.net/k190691/ 2019-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k190691-pixx2430-digital-diagnostic-x-ray-fda-510k.jpg K190691 - Pixx2430 Digital Diagnostic X-Ray Receptor Panel K190691 is a FDA 510(k) cleared radiology medical device. Manufacturer: Pixxgen Corporation. Cleared Apr 2019. https://www.510kdatabase.net/k180232/ 2019-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k180232-daehan-disposable-cup-electrodes-fda-510k.jpg K180232 - DAEHAN Disposable CUP Electrodes K180232 is a FDA 510(k) cleared neurology medical device. Manufacturer: Daehan Medical Systems Co., Ltd.. Cleared Apr 2019. https://www.510kdatabase.net/k182349/ 2019-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k182349-concorde-lift-fda-510k.jpg K182349 - CONCORDE LIFT K182349 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International SARL. Cleared Apr 2019. https://www.510kdatabase.net/k182597/ 2019-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k182597-infrared-thermometer-fda-510k.jpg K182597 - Infrared thermometer K182597 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen Pango Electronic Co., Ltd.. Cleared Apr 2019. https://www.510kdatabase.net/k182872/ 2019-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k182872-link-gemini-sl-total-knee-system-fda-510k.jpg K182872 - LINK GEMINI SL Total Knee System K182872 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Waldemar Link GmbH & Co. KG. Cleared Apr 2019. https://www.510kdatabase.net/k183184/ 2019-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k183184-flarehawk-interbody-fusion-system-fda-510k.jpg K183184 - FlareHawk Interbody Fusion System K183184 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Integrity Implants, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k183376/ 2019-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k183376-horizon-tms-therapy-system-with-fda-510k.jpg K183376 - HORIZON TMS Therapy System with Navigation K183376 is a FDA 510(k) cleared neurology medical device. Manufacturer: Magstim Company, Ltd.. Cleared Apr 2019. https://www.510kdatabase.net/k190230/ 2019-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k190230-ifuse-implant-system-fda-510k.jpg K190230 - iFuse Implant System® K190230 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SI-BONE, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k190289/ 2019-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k190289-karma-fixation-system-fda-510k.jpg K190289 - Karma® Fixation System K190289 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinal Elements, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k190520/ 2019-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k190520-vitros-xt-chemistry-products-glu-ca-fda-510k.jpg K190520 - VITROS XT Chemistry Products GLU-Ca Slides K190520 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Ortho-Clinical Diagnostics, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k190557/ 2019-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k190557-bio-medicus-insertion-kit-fda-510k.jpg K190557 - Bio-Medicus Insertion Kit K190557 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k190586/ 2019-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k190586-monster-screw-system-fda-510k.jpg K190586 - Monster® Screw System K190586 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paragon 28, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k181171/ 2019-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k181171-zimmer-biomet-ceramic-heads-fda-510k.jpg K181171 - Zimmer Biomet Ceramic Heads K181171 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k182836/ 2019-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k182836-fujifilm-endoscope-model-eg-740n-fda-510k.jpg K182836 - FUJIFILM Endoscope Model EG-740N K182836 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fujifilm Corporation. Cleared Apr 2019. https://www.510kdatabase.net/k183320/ 2019-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k183320-ilumien-optis-optis-integrated-optis-fda-510k.jpg K183320 - Ilumien Optis, Optis Integrated, Optis Mobile K183320 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: St. Jude Medical (Now Abbott Medical). Cleared Apr 2019. https://www.510kdatabase.net/k190131/ 2019-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k190131-acqmap-high-resolution-imaging-and-fda-510k.jpg K190131 - AcQMap High Resolution Imaging and Mapping System K190131 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Acutus Medical, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k190248/ 2019-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k190248-arietta-50-fda-510k.jpg K190248 - ARIETTA 50 K190248 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hitachi Healthcare Americas. Cleared Apr 2019. https://www.510kdatabase.net/k181597/ 2019-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k181597-lepen-fda-510k.jpg K181597 - Le'Pen K181597 is a FDA 510(k) cleared dental medical device. Manufacturer: Kmihh, Ltd.. Cleared Apr 2019. https://www.510kdatabase.net/k182221/ 2019-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k182221-bencox-mirabo-cup-multi-hole-fda-510k.jpg K182221 - Bencox Mirabo Cup Multi Hole K182221 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corentec Co., Ltd.. Cleared Apr 2019. https://www.510kdatabase.net/k183343/ 2019-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k183343-vantage-total-ankle-flat-cut-talar-fda-510k.jpg K183343 - Vantage Total Ankle Flat Cut Talar Components K183343 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Apr 2019. https://www.510kdatabase.net/k190180/ 2019-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k190180-cusa-clarity-ultrasonic-surgical-fda-510k.jpg K190180 - CUSA Clarity Ultrasonic Surgical Aspirator System K190180 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Integra LifeSciences Corporation. Cleared Apr 2019. https://www.510kdatabase.net/k190198/ 2019-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k190198-microperimeter-mp-3-microperimeter-mp-fda-510k.jpg K190198 - Microperimeter MP-3, Microperimeter MP-3 Type S K190198 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Nidek Co., Ltd.. Cleared Apr 2019. https://www.510kdatabase.net/k190447/ 2019-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k190447-7400-ultrasound-systems-fda-510k.jpg K190447 - 7400 Ultrasound Systems K190447 is a FDA 510(k) cleared radiology medical device. Manufacturer: Navigant Consulting - on Behalf of Esaote S.P.A.. Cleared Apr 2019. https://www.510kdatabase.net/k190629/ 2019-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k190629-dbswin-and-vistaeasy-imaging-software-fda-510k.jpg K190629 - DBSWIN and VISTAEASY Imaging Software K190629 is a FDA 510(k) cleared radiology medical device. Manufacturer: Durr Dental SE. Cleared Apr 2019. https://www.510kdatabase.net/k180903/ 2019-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k180903-3880-mri-patient-monitoring-system-fda-510k.jpg K180903 - 3880 MRI Patient Monitoring System K180903 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Iradimed Corporation. Cleared Mar 2019. https://www.510kdatabase.net/k180924/ 2019-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k180924-reflect-implant-system-fda-510k.jpg K180924 - Reflect Implant System K180924 is a FDA 510(k) cleared dental medical device. Manufacturer: Ids - Integrated Dental Systems. Cleared Mar 2019. https://www.510kdatabase.net/k181352/ 2019-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k181352-loop-system-fda-510k.jpg K181352 - Loop System K181352 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Spry Health, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k181770/ 2019-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k181770-intrauterine-access-balloon-catheter-fda-510k.jpg K181770 - Intrauterine Access Balloon Catheter, Selective Salpingography Catheter K181770 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Cook Incorporated. Cleared Mar 2019. https://www.510kdatabase.net/k181777/ 2019-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k181777-aggreguide-a-100-adp-fda-510k.jpg K181777 - AggreGuide A-100 ADP K181777 is a FDA 510(k) cleared hematology medical device. Manufacturer: Aggredyne, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k182123/ 2019-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k182123-attest-drug-screen-cup-attest-drug-fda-510k.jpg K182123 - ATTEST Drug Screen Cup, ATTEST Drug Screen Dip Card K182123 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Advin Biotech, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k182164/ 2019-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k182164-ecolab-pou-water-filter-spray-outlet-fda-510k.jpg K182164 - Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU Water Filter Shower Wand K182164 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ecolab, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k182609/ 2019-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k182609-delphos-implants-rigid-fixation-system-fda-510k.jpg K182609 - Delphos Implants Rigid Fixation System K182609 is a FDA 510(k) cleared dental medical device. Manufacturer: Delphos Implants - Ind.Com. Importacao E Exportacao DE. Cleared Mar 2019. https://www.510kdatabase.net/k182720/ 2019-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k182720-freedom-spinal-cord-stimulator-scs-fda-510k.jpg K182720 - Freedom Spinal Cord Stimulator (SCS) System K182720 is a FDA 510(k) cleared neurology medical device. Manufacturer: Stimwave Technologies Incorporated. Cleared Mar 2019. https://www.510kdatabase.net/k182834/ 2019-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k182834-cs-series-fp-with-optional-roi-fda-510k.jpg K182834 - CS-series-FP with Optional ROI Accessory CA-100S K182834 is a FDA 510(k) cleared radiology medical device. Manufacturer: Omega Medical Imaging, LLC. Cleared Mar 2019. https://www.510kdatabase.net/k182965/ 2019-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k182965-bl-cart-iol-delivery-cartridge-fda-510k.jpg K182965 - BL-Cart IOL Delivery Cartridge K182965 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Ast Products, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k182981/ 2019-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k182981-confirm-rx-insertable-cardiac-monitor-fda-510k.jpg K182981 - Confirm Rx Insertable Cardiac Monitor K182981 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott. Cleared Mar 2019. https://www.510kdatabase.net/k183210/ 2019-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k183210-thoracic-vcar-with-gsi-pulmonary-fda-510k.jpg K183210 - Thoracic VCAR with GSI Pulmonary Perfusion K183210 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems SCS. Cleared Mar 2019. https://www.510kdatabase.net/k183508/ 2019-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k183508-micro-transgastric-jejunal-feeding-fda-510k.jpg K183508 - Micro Transgastric-Jejunal Feeding Device K183508 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Applied Medical Technology, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k183579/ 2019-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k183579-nalu-neurostimulation-kit-integrated-fda-510k.jpg K183579 - Nalu Neurostimulation Kit (Integrated, 40 cm: Single 8/Dual 8), Nalu Neurostimulation Kit (Ported, 2 cm: Single 8/Dual 8), Dual 8 Ported Nalu Implantable Pulse Generator with 40 cm Kit, 40 cm/ 60 cm Trial/Extension Lead Kits, Patient Kits and miscellaneous replacement kits K183579 is a FDA 510(k) cleared neurology medical device. Manufacturer: Boston Scientific Neuromodulation. Cleared Mar 2019. https://www.510kdatabase.net/k183596/ 2019-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k183596-klassic-knee-system-klassic-knee-ps-fda-510k.jpg K183596 - Klassic Knee System - Klassic Knee PS-Post Femur K183596 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Total Joint Orthopedics, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k190023/ 2019-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k190023-btl-084-fda-510k.jpg K190023 - BTL-084 K190023 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: BTL Industries, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k190178/ 2019-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k190178-monaco-rtp-system-fda-510k.jpg K190178 - Monaco RTP System K190178 is a FDA 510(k) cleared radiology medical device. Manufacturer: Elekta, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k190648/ 2019-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k190648-pusen-eview-medical-video-endoscope-fda-510k.jpg K190648 - Pusen Eview Medical Video Endoscope Image Processor K190648 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Zhuhai Pusen Medical Technology Co., Ltd.. Cleared Mar 2019. https://www.510kdatabase.net/k181505/ 2019-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k181505-vac-dermatac-drape-fda-510k.jpg K181505 - V.A.C. DERMATAC Drape K181505 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Kci USA, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k181745/ 2019-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k181745-fujifilm-duodenoscope-model-fda-510k.jpg K181745 - FUJIFILM Duodenoscope Model K181745 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fujifilm Corporation. Cleared Mar 2019. https://www.510kdatabase.net/k182176/ 2019-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k182176-polychloroprene-powder-free-sterile-fda-510k.jpg K182176 - Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy Drugs K182176 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Pt. Medisafe Technologies. Cleared Mar 2019. https://www.510kdatabase.net/k190186/ 2019-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k190186-acclarix-ax4-diagnostic-ultrasound-fda-510k.jpg K190186 - Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound System K190186 is a FDA 510(k) cleared radiology medical device. Manufacturer: Edan Instruments, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k190303/ 2019-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k190303-airseal-fda-510k.jpg K190303 - AirSeal K190303 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Conmed Corporation. Cleared Mar 2019. https://www.510kdatabase.net/den180012/ 2019-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/den180012-loadpro-intraoperative-rod-strain-sensor-fda-510k.jpg DEN180012 - LOADPRO™ Intraoperative Rod Strain Sensor DEN180012 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Intellirod Spine, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/den180024/ 2019-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/den180024-leica-fl400-fda-510k.jpg DEN180024 - Leica FL400 DEN180024 is a FDA 510(k) cleared neurology medical device. Manufacturer: Leica Microsystems (Schweiz) AG. Cleared Mar 2019. https://www.510kdatabase.net/k181735/ 2019-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k181735-percutaneous-neonatal-pigtail-fda-510k.jpg K181735 - Percutaneous Neonatal Pigtail Nephrostomy Set, Pediatric Nephrostomy Stent Set K181735 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Mar 2019. https://www.510kdatabase.net/k181882/ 2019-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k181882-ekuore-one-electronic-interface-for-fda-510k.jpg K181882 - eKuore One electronic interface for stethoscope K181882 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Chip Ideas Electronics S.L.. Cleared Mar 2019. https://www.510kdatabase.net/k181929/ 2019-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k181929-mimotm-negative-pressure-wound-therapy-fda-510k.jpg K181929 - MiMo(TM) Negative Pressure Wound Therapy System K181929 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Baymax Research, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k182738/ 2019-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k182738-single-and-multi-drug-rapid-test-panel-fda-510k.jpg K182738 - Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine) K182738 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Hangzhou AllTest Biotech Co., Ltd.. Cleared Mar 2019. https://www.510kdatabase.net/k182821/ 2019-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k182821-accutorr-7vs-900vs-900c-vital-signs-fda-510k.jpg K182821 - Accutorr 7/VS-900/VS-900c Vital Signs Monitor K182821 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Mar 2019. https://www.510kdatabase.net/k182835/ 2019-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k182835-wolf-thrombectomy-device-fda-510k.jpg K182835 - WOLF Thrombectomy Device K182835 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: 880 Medical, LLC. Cleared Mar 2019. https://www.510kdatabase.net/k183105/ 2019-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k183105-mimics-medical-fda-510k.jpg K183105 - Mimics Medical K183105 is a FDA 510(k) cleared radiology medical device. Manufacturer: Materialise NV. Cleared Mar 2019. https://www.510kdatabase.net/k183410/ 2019-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k183410-amsco-600-steam-sterilizer-fda-510k.jpg K183410 - AMSCO 600 Steam Sterilizer K183410 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Mar 2019. https://www.510kdatabase.net/k190073/ 2019-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k190073-wearable-device-home-package-in-carry-fda-510k.jpg K190073 - Wearable Device, Home Package in Carry Case with Homehub, Home Package in Carry Case without Homehub K190073 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Current Health , Ltd.. Cleared Mar 2019. https://www.510kdatabase.net/k190242/ 2019-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k190242-tyto-thermometer-fda-510k.jpg K190242 - Tyto Thermometer K190242 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Tyto Care , Ltd.. Cleared Mar 2019. https://www.510kdatabase.net/k190302/ 2019-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k190302-cdc-human-influenza-virus-real-time-rt-fda-510k.jpg K190302 - CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A/B Typing Kit, CDC Human Influenza Virus Real-time RT-PCR Diagnostic Panel, Influenza A Subtyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza B Lineage Genotyping Kit, CDC Human Influenza Virus Real-time RT-PCR, Influenza A/HS Subtyping Kit K190302 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Centers For Disease Control and Prevention. Cleared Mar 2019. https://www.510kdatabase.net/k190446/ 2019-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k190446-responsive-arthroscopy-wedge-push-in-fda-510k.jpg K190446 - Responsive Arthroscopy Wedge Push-In Suture Anchors K190446 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Responsive Arthroscopy, LLC. Cleared Mar 2019. https://www.510kdatabase.net/k190490/ 2019-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k190490-vitros-xt-chemistry-products-trig-chol-fda-510k.jpg K190490 - VITROS XT Chemistry Products TRIG-CHOL Slides K190490 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Ortho-Clinical Diagnostics, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k181658/ 2019-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k181658-mobileecg-2-bt-fda-510k.jpg K181658 - MobileECG 2 BT K181658 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Memtec Corporation. Cleared Mar 2019. https://www.510kdatabase.net/k181817/ 2019-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k181817-transglidext-expandable-introducer-fda-510k.jpg K181817 - transGlideXT Expandable Introducer K181817 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Transaortic Medical, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k181858/ 2019-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k181858-electric-handpiece-motor-fda-510k.jpg K181858 - Electric Handpiece Motor K181858 is a FDA 510(k) cleared dental medical device. Manufacturer: W&H Dentalwerk Buermoos GmbH. Cleared Mar 2019. https://www.510kdatabase.net/k182897/ 2019-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k182897-velano-vascular-q2-extension-set-fda-510k.jpg K182897 - Velano Vascular Q2 Extension Set K182897 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Velano Vascular. Cleared Mar 2019. https://www.510kdatabase.net/k182947/ 2019-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k182947-dental-pain-eraser-fda-510k.jpg K182947 - Dental Pain Eraser K182947 is a FDA 510(k) cleared dental medical device. Manufacturer: Synapse Dental, LLC. Cleared Mar 2019. https://www.510kdatabase.net/k183154/ 2019-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k183154-sm-electrodes-fda-510k.jpg K183154 - SM Electrodes K183154 is a FDA 510(k) cleared neurology medical device. Manufacturer: Hong Qiangxing (Shenzhen) Electronics Limited. Cleared Mar 2019. https://www.510kdatabase.net/k183628/ 2019-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k183628-arthrex-tensionloc-system-fda-510k.jpg K183628 - Arthrex TensionLoc System K183628 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k190232/ 2019-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k190232-synapse-pacs-fda-510k.jpg K190232 - Synapse PACS K190232 is a FDA 510(k) cleared radiology medical device. Manufacturer: Fujifilm Corporation. Cleared Mar 2019. https://www.510kdatabase.net/k190392/ 2019-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k190392-wavelight-fs200-patient-interface-fda-510k.jpg K190392 - WaveLight FS200 Patient Interface K190392 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Alcon Laboratories, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k190404/ 2019-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k190404-otis-optical-coherence-tomography-system-fda-510k.jpg K190404 - OTIS Optical Coherence Tomography SYstem K190404 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Perimeter Medical Imaging, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k181716/ 2019-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k181716-intouch-thermal-camera-fda-510k.jpg K181716 - InTouch Thermal Camera K181716 is a FDA 510(k) cleared radiology medical device. Manufacturer: Intouch Technologies, Inc., D.B.A. Intouch Health. Cleared Mar 2019. https://www.510kdatabase.net/k181778/ 2019-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k181778-mutars-proximal-femur-replacement-system-fda-510k.jpg K181778 - MUTARS Proximal Femur Replacement System K181778 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Implantcast GmbH. Cleared Mar 2019. https://www.510kdatabase.net/k181905/ 2019-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k181905-axios-stent-and-delivery-system-axios-fda-510k.jpg K181905 - AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System K181905 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Mar 2019. https://www.510kdatabase.net/k190015/ 2019-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k190015-ballancer-gold-1212-fda-510k.jpg K190015 - Ballancer Gold, 1212 K190015 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Mego Afek AC , Ltd.. Cleared Mar 2019. https://www.510kdatabase.net/k190093/ 2019-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k190093-rezum-delivery-device-rezum-generator-fda-510k.jpg K190093 - Rezum Delivery Device, Rezum Generator K190093 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Nxthera (A Boston Scientific Company). Cleared Mar 2019. https://www.510kdatabase.net/k183491/ 2019-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k183491-arm-blood-pressure-monitor-fda-510k.jpg K183491 - Arm Blood Pressure Monitor K183491 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Xuzhou Yongkang Electronic Science Technology Co., Ltd.. Cleared Mar 2019. https://www.510kdatabase.net/k181173/ 2019-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k181173-elmed-laparoscopic-instruments-and-fda-510k.jpg K181173 - ELMED Laparoscopic Instruments and Accessories K181173 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Elmed Incorporated. Cleared Mar 2019. https://www.510kdatabase.net/k181360/ 2019-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k181360-on-q-pump-with-bolus-fda-510k.jpg K181360 - ON-Q* Pump with Bolus K181360 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Halyard Health. Cleared Mar 2019. https://www.510kdatabase.net/k181624/ 2019-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k181624-microstream-advance-neonatal-infant-fda-510k.jpg K181624 - Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line K181624 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Oridion Medical 1987 , Ltd.. Cleared Mar 2019. https://www.510kdatabase.net/k181722/ 2019-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k181722-polyethylene-catheter-fda-510k.jpg K181722 - Polyethylene Catheter K181722 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Mar 2019. https://www.510kdatabase.net/k181738/ 2019-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k181738-medline-renewal-reprocessed-oximax-fda-510k.jpg K181738 - Medline ReNewal Reprocessed OxiMax Pulse Oximetry Sensors K181738 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Surgical Instrument Service and Savings Inc (Dba Medline. Cleared Mar 2019. https://www.510kdatabase.net/k181959/ 2019-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k181959-halyard-smart-fold-sterilization-wrap-fda-510k.jpg K181959 - HALYARD SMART-FOLD* Sterilization Wrap (H450, H650) K181959 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Owens & Minor Halyard, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k182186/ 2019-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k182186-cmos-video-rhino-laryngoscope-system-fda-510k.jpg K182186 - CMOS Video-Rhino-Laryngoscope System K182186 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k182395/ 2019-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k182395-oartrac-system-fda-510k.jpg K182395 - OARtrac System K182395 is a FDA 510(k) cleared radiology medical device. Manufacturer: Radialdyne, LLC. Cleared Mar 2019. https://www.510kdatabase.net/k182554/ 2019-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k182554-powder-free-nitrile-examination-gloves-fda-510k.jpg K182554 - Powder Free Nitrile Examination Gloves, Blue, Tested for Use with Chemotherapy Drugs K182554 is a FDA 510(k) cleared general hospital medical device. Manufacturer: He Chuang Plastic & Rubber Co., Ltd.. Cleared Mar 2019. https://www.510kdatabase.net/k182700/ 2019-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k182700-nexstim-navigated-brain-therapy-nbt-fda-510k.jpg K182700 - Nexstim Navigated Brain Therapy (NBT) System 2 K182700 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nexstim Plc. Cleared Mar 2019. https://www.510kdatabase.net/k182848/ 2019-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k182848-rosa-one-spine-application-fda-510k.jpg K182848 - ROSA ONE Spine application K182848 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtech S.A. Cleared Mar 2019. https://www.510kdatabase.net/k182861/ 2019-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k182861-shiley-neonatalpediatric-tracheostomy-fda-510k.jpg K182861 - Shiley Neonatal/Pediatric Tracheostomy Tube K182861 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Covidien. Cleared Mar 2019. https://www.510kdatabase.net/k182887/ 2019-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k182887-masimo-rad-67-pulse-co-oximeter-and-fda-510k.jpg K182887 - Masimo Rad-67 Pulse CO-Oximeter and Accessories K182887 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Masimo Corporation. Cleared Mar 2019. https://www.510kdatabase.net/k182948/ 2019-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k182948-gammex-pi-hybrid-surgical-gloves-fda-510k.jpg K182948 - Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs K182948 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ansell Healthcare Products, LLC. Cleared Mar 2019. https://www.510kdatabase.net/k183047/ 2019-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k183047-nalu-neurostimulation-system-fda-510k.jpg K183047 - Nalu Neurostimulation System K183047 is a FDA 510(k) cleared neurology medical device. Manufacturer: Boston Scientific Neuromodulation. Cleared Mar 2019. https://www.510kdatabase.net/k183164/ 2019-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k183164-uws-mr-fda-510k.jpg K183164 - uWS-MR K183164 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Mar 2019. https://www.510kdatabase.net/k183353/ 2019-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k183353-telescope-guide-extension-catheter-fda-510k.jpg K183353 - Telescope Guide Extension Catheter K183353 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k183400/ 2019-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k183400-envisio-navigation-sytem-fda-510k.jpg K183400 - EnVisio Navigation Sytem K183400 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Elucent Medical, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k183608/ 2019-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k183608-aristotle-18-guidewire-200cm-soft-fda-510k.jpg K183608 - Aristotle 18 Guidewire, 200cm, Soft Profile K183608 is a FDA 510(k) cleared neurology medical device. Manufacturer: Scientia Vascular, LLC. Cleared Mar 2019. https://www.510kdatabase.net/k190104/ 2019-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k190104-system-1e-liquid-chemical-sterilant-fda-510k.jpg K190104 - SYSTEM 1E Liquid Chemical Sterilant Processing System, SYSTEM 1 Endo Liquid Chemical Sterilant Processing System K190104 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Steris Corporations. Cleared Mar 2019. https://www.510kdatabase.net/k190252/ 2019-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k190252-mts-gentamicin-0016-256-gml-fda-510k.jpg K190252 - MTS Gentamicin 0.016 - 256 µg/mL K190252 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Liofilchem S. R. L.. Cleared Mar 2019. https://www.510kdatabase.net/k190430/ 2019-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k190430-osteocentric-bone-plate-and-screw-system-fda-510k.jpg K190430 - OsteoCentric Bone Plate and Screw System K190430 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteocentric Trauma. Cleared Mar 2019. https://www.510kdatabase.net/k173191/ 2019-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k173191-ad-medical-blood-pressure-monitors-fda-510k.jpg K173191 - A&D Medical Blood Pressure Monitors K173191 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: A&D Company, Ltd.. Cleared Mar 2019. https://www.510kdatabase.net/k181822/ 2019-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k181822-renasys-touch-fda-510k.jpg K181822 - RENASYS Touch K181822 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew Medical Limited. Cleared Mar 2019. https://www.510kdatabase.net/k182064/ 2019-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k182064-expansure-transseptal-dilation-system-fda-510k.jpg K182064 - ExpanSure Transseptal Dilation System K182064 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baylis Medical Company, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k182074/ 2019-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k182074-mineral-collagen-composite-bioactive-fda-510k.jpg K182074 - Mineral Collagen Composite Bioactive Moldable K182074 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Collagen Matrix, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k182918/ 2019-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k182918-ballast-088-long-sheath-fda-510k.jpg K182918 - Ballast 088 Long Sheath K182918 is a FDA 510(k) cleared neurology medical device. Manufacturer: Balt USA, LLC. Cleared Mar 2019. https://www.510kdatabase.net/k183582/ 2019-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k183582-mpact-extension-fda-510k.jpg K183582 - MPACT Extension K183582 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Mar 2019. https://www.510kdatabase.net/k183592/ 2019-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k183592-clearllab-10c-panels-b-t-m1-m2-navios-fda-510k.jpg K183592 - ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer K183592 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter. Cleared Mar 2019. https://www.510kdatabase.net/k190377/ 2019-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k190377-urolift-system-ul400-fda-510k.jpg K190377 - UroLift System UL400 K190377 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Neotract, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k190380/ 2019-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k190380-nvc-fda-510k.jpg K190380 - nvc K190380 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nvision Biomedical Technologies, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k190412/ 2019-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k190412-clungene-multi-drug-test-dip-card-fda-510k.jpg K190412 - CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup K190412 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Hangzhou Clongene Biotech Co., Ltd.. Cleared Mar 2019. https://www.510kdatabase.net/k190418/ 2019-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k190418-nuvasive-versatie-system-fda-510k.jpg K190418 - NuVasive® VersaTie® System K190418 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Mar 2019. https://www.510kdatabase.net/k190425/ 2019-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k190425-castleloc-p-anterior-cervical-plate-fda-510k.jpg K190425 - CastleLoc-P Anterior Cervical Plate System K190425 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: L & K Biomed Co., Ltd.. Cleared Mar 2019. https://www.510kdatabase.net/k190431/ 2019-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k190431-route-92-medical-delivery-catheter-fda-510k.jpg K190431 - Route 92 Medical Delivery Catheter K190431 is a FDA 510(k) cleared neurology medical device. Manufacturer: Route 92 Medical, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k182511/ 2019-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k182511-simplcath-fda-510k.jpg K182511 - SimplCath K182511 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: F&S Medical Solutions, LLC. Cleared Mar 2019. https://www.510kdatabase.net/k183399/ 2019-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k183399-bd-nexiva-closed-iv-catheter-system-fda-510k.jpg K183399 - BD Nexiva Closed IV Catheter System K183399 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton Dickinson Infusion Therapy Systems, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k183408/ 2019-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k183408-jensen-shade-effect-liquids-fda-510k.jpg K183408 - Jensen Shade Effect Liquids K183408 is a FDA 510(k) cleared dental medical device. Manufacturer: Jensen Industries, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k183414/ 2019-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k183414-absolu-fda-510k.jpg K183414 - ABSOLU K183414 is a FDA 510(k) cleared radiology medical device. Manufacturer: Quantel Medical. Cleared Mar 2019. https://www.510kdatabase.net/k183543/ 2019-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k183543-activac-therapy-unit-fda-510k.jpg K183543 - ACTIV.A.C. Therapy Unit K183543 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Kci USA, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k183575/ 2019-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k183575-acuson-s3000-s2000-diagnostic-fda-510k.jpg K183575 - ACUSON S3000, S2000 Diagnostic Ultrasound System K183575 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Healthineers. Cleared Mar 2019. https://www.510kdatabase.net/k180098/ 2019-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k180098-servo-u-ventilator-system-version-21-fda-510k.jpg K180098 - SERVO-U Ventilator System version 2.1 K180098 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Maquet Critical Care AB. Cleared Mar 2019. https://www.510kdatabase.net/k182383/ 2019-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k182383-non-sterile-pf-nitrile-examination-fda-510k.jpg K182383 - Non-Sterile, PF Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs-Blue K182383 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Yty Industry (Manjung) Sdn Bhd. Cleared Mar 2019. https://www.510kdatabase.net/k182468/ 2019-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k182468-trident-x3-acetabular-inserts-adm-and-fda-510k.jpg K182468 - Trident X3 Acetabular Inserts, ADM and MDM X3 Acetabular Inserts, Accolade II Hip System K182468 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. Cleared Mar 2019. https://www.510kdatabase.net/k182793/ 2019-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k182793-ap3600-automated-instrument-fda-510k.jpg K182793 - AP3600 Automated Instrument K182793 is a FDA 510(k) cleared immunology medical device. Manufacturer: Hitachi Chemical Diagnostics, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k183019/ 2019-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k183019-sis-software-version-330-fda-510k.jpg K183019 - SIS Software version 3.3.0 K183019 is a FDA 510(k) cleared radiology medical device. Manufacturer: Surgical Information Sciences, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k183527/ 2019-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k183527-mts-ciprofloxacin-0002-32-gml-fda-510k.jpg K183527 - MTS Ciprofloxacin 0.002 - 32 µg/mL K183527 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Liofilchem S. R. L.. Cleared Mar 2019. https://www.510kdatabase.net/k183529/ 2019-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k183529-ae-120a-eeg-head-set-fda-510k.jpg K183529 - AE-120A EEG Head Set K183529 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nihon Kohden Corporation. Cleared Mar 2019. https://www.510kdatabase.net/k190379/ 2019-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k190379-mim-on-linux-fda-510k.jpg K190379 - MIM on Linux K190379 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mim Software, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k190423/ 2019-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k190423-devon-24d-deep-vein-thrombosis-dvt-fda-510k.jpg K190423 - Devon 24D Deep Vein Thrombosis (DVT) Prevention Therapy System K190423 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Devon Medical Products (Jiangsu), Ltd.. Cleared Mar 2019. https://www.510kdatabase.net/k181599/ 2019-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k181599-unicel-dxh-800-cellular-analysis-fda-510k.jpg K181599 - Unicel DxH 800 Cellular Analysis System with Early Sepsis Indicator Application K181599 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Beckman Coulter. Cleared Mar 2019. https://www.510kdatabase.net/k183260/ 2019-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k183260-sensilight-pro-pistol-ipl-fda-510k.jpg K183260 - Sensilight Pro / Pistol IPL K183260 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: El Global Trade, Ltd.. Cleared Mar 2019. https://www.510kdatabase.net/k183296/ 2019-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k183296-real-immersive-system-fda-510k.jpg K183296 - REAL Immersive System K183296 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Penumbra, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k183344/ 2019-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k183344-the-progressive-orthopaedic-company-fda-510k.jpg K183344 - The Progressive Orthopaedic Company Total Knee System II K183344 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: The Progressive Orthopaedic Company, LLC. Cleared Mar 2019. https://www.510kdatabase.net/k183511/ 2019-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k183511-affinity-pixie-oxygenator-with-balance-fda-510k.jpg K183511 - Affinity Pixie™ Oxygenator with Balance™ Biosurface (Model BBP211), Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir with Balance™ Biosurface (Model BBP241), Affinity Pixie™ Oxygenator with Cortiva™ BioActive Surface (Model CBP211), Affinity Pixie™ Oxygenator and Cardiotomy/Venous Reservoir with Cortiva™ BioActive Surface (Model CBP241) K183511 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k183518/ 2019-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k183518-preat-abutments-fda-510k.jpg K183518 - Preat Abutments K183518 is a FDA 510(k) cleared dental medical device. Manufacturer: Preat Corporation. Cleared Mar 2019. https://www.510kdatabase.net/k190204/ 2019-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k190204-id-now-influenza-a-b-2-fda-510k.jpg K190204 - ID NOW Influenza A & B 2 K190204 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Alere Scarborough, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k190333/ 2019-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k190333-paradigm-all-suture-anchor-18mm-fda-510k.jpg K190333 - Paradigm All-Suture Anchor 1.8mm, White/Black #2 K190333 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Conmed Corporation. Cleared Mar 2019. https://www.510kdatabase.net/k190354/ 2019-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k190354-braun-silkexpert-pro-5-fda-510k.jpg K190354 - BRAUN Silk.expert Pro 5 K190354 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cyden Limited. Cleared Mar 2019. https://www.510kdatabase.net/k190361/ 2019-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k190361-zavation-spinal-system-fda-510k.jpg K190361 - Zavation Spinal System K190361 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zavation Medical Products, LLC. Cleared Mar 2019. https://www.510kdatabase.net/k190366/ 2019-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k190366-braun-silk-expert-pro-3-fda-510k.jpg K190366 - BRAUN Silk Expert Pro 3 K190366 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cyden Limited. Cleared Mar 2019. https://www.510kdatabase.net/k190359/ 2019-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k190359-sonendo-gentlewave-system-fda-510k.jpg K190359 - Sonendo GentleWave System K190359 is a FDA 510(k) cleared dental medical device. Manufacturer: Sonendo, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k180127/ 2019-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k180127-tcat-r-tha-instrument-tray-set-fda-510k.jpg K180127 - TCAT (R) THA Instrument Tray Set K180127 is a FDA 510(k) cleared general hospital medical device. Manufacturer: THINK Surgical, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k181633/ 2019-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k181633-mtf-pre-sutured-tendon-fda-510k.jpg K181633 - MTF Pre-Sutured Tendon K181633 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Musculoskeletal Transplant Foundation. Cleared Mar 2019. https://www.510kdatabase.net/k182022/ 2019-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k182022-apexmv-fda-510k.jpg K182022 - ApexMV K182022 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Incontrol Medical, LLC. Cleared Mar 2019. https://www.510kdatabase.net/k182571/ 2019-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k182571-cardioflux-with-faraday-analytical-cloud-fda-510k.jpg K182571 - CardioFlux with Faraday Analytical Cloud K182571 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Genetesis, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k182639/ 2019-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k182639-mobilett-elara-max-fda-510k.jpg K182639 - MOBILETT Elara Max K182639 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medi Cal Solutions, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k182813/ 2019-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k182813-cohitech-organic-cotton-applicator-fda-510k.jpg K182813 - COHITECH ORGANIC COTTON APPLICATOR TAMPONS LIGHT K182813 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Cotton High Tech S.L.. Cleared Mar 2019. https://www.510kdatabase.net/k182853/ 2019-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k182853-horizon-tms-therapy-system-fda-510k.jpg K182853 - HORIZON TMS Therapy System K182853 is a FDA 510(k) cleared neurology medical device. Manufacturer: Magstim Company, Ltd.. Cleared Mar 2019. https://www.510kdatabase.net/k183187/ 2019-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k183187-nextaro-transfer-system-nextaro-va-fda-510k.jpg K183187 - nextaro Transfer System, nextaro va K183187 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sfm Medical Devices GmbH. Cleared Mar 2019. https://www.510kdatabase.net/k183426/ 2019-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k183426-mectalif-anterior-stand-alone-extension-fda-510k.jpg K183426 - MectaLIF Anterior Stand Alone Extension K183426 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Mar 2019. https://www.510kdatabase.net/k183493/ 2019-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k183493-selectsite-c304-his-deflectable-fda-510k.jpg K183493 - SelectSite C304-HIS Deflectable Catheter System K183493 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k183501/ 2019-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k183501-parcus-twist-ap-suture-anchors-fda-510k.jpg K183501 - Parcus Twist AP Suture Anchors K183501 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Parcus Medical, LLC. Cleared Mar 2019. https://www.510kdatabase.net/k183657/ 2019-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k183657-vantage-galan-3t-mrt-3020a9-v50-fda-510k.jpg K183657 - Vantage Galan 3T, MRT-3020/A9, V5.0 K183657 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Mar 2019. https://www.510kdatabase.net/k190099/ 2019-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k190099-veloxion-controller-kit-veloxion-fluid-fda-510k.jpg K190099 - Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch K190099 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Corinth Medtech, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k190280/ 2019-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k190280-klassic-knee-system-sombrero-patella-fda-510k.jpg K190280 - Klassic Knee System - Sombrero Patella with Standard Poly, Klassic Knee System - Sombrero Patella with E-Link Poly K190280 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Total Joint Orthopedics, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k190294/ 2019-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k190294-cell-dyn-emerald-22-al-system-fda-510k.jpg K190294 - CELL-DYN Emerald 22 AL System K190294 is a FDA 510(k) cleared hematology medical device. Manufacturer: Abbott Laboratories. Cleared Mar 2019. https://www.510kdatabase.net/k190347/ 2019-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k190347-hivox-otc-electrical-stimulator-fda-510k.jpg K190347 - HIVOX OTC Electrical Stimulator K190347 is a FDA 510(k) cleared neurology medical device. Manufacturer: Hivox Biotek, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k190357/ 2019-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k190357-star-x-intraoral-x-ray-system-fda-510k.jpg K190357 - Star-X, Intraoral X-ray System K190357 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hdx Will Corp.. Cleared Mar 2019. https://www.510kdatabase.net/k190373/ 2019-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k190373-sonialvision-g4-fda-510k.jpg K190373 - SonialVision G4 K190373 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shimadzu Corporation. Cleared Mar 2019. https://www.510kdatabase.net/k190401/ 2019-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k190401-mamba-and-mamba-flex-microcatheters-fda-510k.jpg K190401 - MAMBA and MAMBA Flex Microcatheters K190401 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Mar 2019. https://www.510kdatabase.net/k190476/ 2019-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k190476-fujifilm-sonosite-vevo-md-imaging-system-fda-510k.jpg K190476 - FUJIFILM Sonosite Vevo MD Imaging System K190476 is a FDA 510(k) cleared radiology medical device. Manufacturer: FUJIFILM Sonosite, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k180337/ 2019-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k180337-europa-pedicle-screw-system-fda-510k.jpg K180337 - EUROPA Pedicle Screw System K180337 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: MiRus, LLC. Cleared Mar 2019. https://www.510kdatabase.net/k181669/ 2019-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k181669-convertx-biliary-stent-system-fda-510k.jpg K181669 - ConvertX Biliary Stent System K181669 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Brightwater Medical. Cleared Mar 2019. https://www.510kdatabase.net/k182203/ 2019-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k182203-jkh-stimulator-plus-fda-510k.jpg K182203 - JKH Stimulator Plus K182203 is a FDA 510(k) cleared neurology medical device. Manufacturer: Jkh USA, LLC. Cleared Mar 2019. https://www.510kdatabase.net/k182371/ 2019-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k182371-da-vinci-sp-surgical-system-endowrist-fda-510k.jpg K182371 - da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories K182371 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k182475/ 2019-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k182475-signia-circular-adapters-for-use-with-fda-510k.jpg K182475 - Signia Circular Adapters (for use with Signia Staplers), Tri-Staple 2.0 Circular Reloads (for use with Signia Circular Adapters) K182475 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien. Cleared Mar 2019. https://www.510kdatabase.net/k182579/ 2019-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k182579-omron-model-bp7900-blood-pressure-fda-510k.jpg K182579 - Omron Model BP7900 Blood Pressure Monitor + EKG K182579 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Omron Healthcare, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k182589/ 2019-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k182589-bd-plastipak-syringe-fda-510k.jpg K182589 - BD Plastipak Syringe K182589 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson and Company. Cleared Mar 2019. https://www.510kdatabase.net/k183142/ 2019-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k183142-pathvisionxl-fda-510k.jpg K183142 - PathVisionXL K183142 is a FDA 510(k) cleared radiology medical device. Manufacturer: Faxitron Bioptics, LLC. Cleared Mar 2019. https://www.510kdatabase.net/k183247/ 2019-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k183247-dpl-faceware-fda-510k.jpg K183247 - dpl Faceware K183247 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Led Technologies, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k183380/ 2019-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k183380-tetric-powerfill-fda-510k.jpg K183380 - Tetric PowerFill K183380 is a FDA 510(k) cleared dental medical device. Manufacturer: Ivoclar Vivadent, AG. Cleared Mar 2019. https://www.510kdatabase.net/k183573/ 2019-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k183573-vstrip-h-pylori-antigen-rapid-test-fda-510k.jpg K183573 - Vstrip H. pylori Antigen Rapid Test K183573 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Panion & BF Biotech, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k190168/ 2019-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k190168-aquas-probes-fda-510k.jpg K190168 - Aquas Probes K190168 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Genicon, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k190283/ 2019-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k190283-prostim-injectable-inductive-graft-fda-510k.jpg K190283 - PROSTIM Injectable Inductive Graft K190283 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Mar 2019. https://www.510kdatabase.net/k190285/ 2019-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k190285-l300-go-system-fda-510k.jpg K190285 - L300 Go System K190285 is a FDA 510(k) cleared neurology medical device. Manufacturer: Bioness, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k190318/ 2019-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k190318-vasoband-vascular-compression-device-fda-510k.jpg K190318 - VASOBand Vascular Compression Device K190318 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vasoinnovations, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k190326/ 2019-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k190326-vitros-xt-chemistry-products-urea-crea-fda-510k.jpg K190326 - VITROS XT Chemistry Products UREA-CREA Slides K190326 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Ortho-Clinical Diagnostics, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/den170044/ 2019-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/den170044-clearmate-fda-510k.jpg DEN170044 - ClearMate DEN170044 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Thornhill Research, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k181668/ 2019-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k181668-fastouch-absorbable-fixation-system-fda-510k.jpg K181668 - FasTouch Absorbable Fixation System K181668 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Via Surgical , Ltd.. Cleared Mar 2019. https://www.510kdatabase.net/k182502/ 2019-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k182502-alteon-acetabular-cup-system-fda-510k.jpg K182502 - Alteon Acetabular Cup System K182502 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k182570/ 2019-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k182570-venture-0014-catheter-fda-510k.jpg K182570 - Venture 0.014 Catheter K182570 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vascular Solutions, LLC. Cleared Mar 2019. https://www.510kdatabase.net/k182920/ 2019-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k182920-mirus-lumbar-interbody-fusion-system-fda-510k.jpg K182920 - MiRus™ Lumbar Interbody Fusion System consisting of CALLISTO™ PEEK Posterior Lumbar Interbody Fusion (PLIF) K182920 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: MiRus, LLC. Cleared Mar 2019. https://www.510kdatabase.net/k183026/ 2019-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k183026-wright-jones-fracture-system-fda-510k.jpg K183026 - Wright Jones Fracture System K183026 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Mar 2019. https://www.510kdatabase.net/k183113/ 2019-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k183113-depuy-synthes-maxillofacial-portfolio-fda-510k.jpg K183113 - DePuy Synthes Maxillofacial Portfolio - MR Conditional K183113 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes USA Products, LLC. Cleared Mar 2019. https://www.510kdatabase.net/k183238/ 2019-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k183238-benevision-central-monitoring-system-fda-510k.jpg K183238 - BeneVision Central Monitoring System K183238 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Mar 2019. https://www.510kdatabase.net/k183430/ 2019-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k183430-modular-spinal-fixation-system-fda-510k.jpg K183430 - Modular Spinal Fixation System K183430 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k183463/ 2019-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k183463-axs-catalyst-distal-access-catheter-fda-510k.jpg K183463 - AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Access Catheter 068 x 132cm K183463 is a FDA 510(k) cleared neurology medical device. Manufacturer: Stryker. Cleared Mar 2019. https://www.510kdatabase.net/k183464/ 2019-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k183464-axs-catalyst-7-distal-access-catheter-fda-510k.jpg K183464 - AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm) K183464 is a FDA 510(k) cleared neurology medical device. Manufacturer: Stryker. Cleared Mar 2019. https://www.510kdatabase.net/k183472/ 2019-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k183472-depuy-synthes-porous-polyethylene-fda-510k.jpg K183472 - DePuy Synthes Porous Polyethylene Implants and Titanium Wires Portfolio – MR Conditional K183472 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Synthes USA Products, LLC. Cleared Mar 2019. https://www.510kdatabase.net/k183492/ 2019-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k183492-jusha-c620g-lcd-monitor-jusha-c620-lcd-fda-510k.jpg K183492 - JUSHA-C620G LCD Monitor, JUSHA-C620 LCD Monitor, C620G LCD Monitor, C620 LCD Monitor K183492 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nanjing Jusha Display Technology Co., Ltd.. Cleared Mar 2019. https://www.510kdatabase.net/k183600/ 2019-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k183600-anchor-bag-alone-tissue-retrieval-fda-510k.jpg K183600 - Anchor Bag-Alone Tissue Retrieval System by ConMed K183600 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Conmed Corporation. Cleared Mar 2019. https://www.510kdatabase.net/k190296/ 2019-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k190296-gammatile-fda-510k.jpg K190296 - GammaTile K190296 is a FDA 510(k) cleared radiology medical device. Manufacturer: Gt Medical Technologies. Cleared Mar 2019. https://www.510kdatabase.net/k190300/ 2019-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k190300-biok7600w-wireless-flat-panel-detector-fda-510k.jpg K190300 - BIOK7600W Wireless Flat Panel Detector K190300 is a FDA 510(k) cleared radiology medical device. Manufacturer: Biokinemetrics, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k190311/ 2019-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k190311-biok7600-flat-panel-detector-fda-510k.jpg K190311 - BIOK7600 Flat Panel Detector K190311 is a FDA 510(k) cleared radiology medical device. Manufacturer: Biokinemetrics, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k190368/ 2019-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k190368-enhanced-feature-software-pack-cxdi-fda-510k.jpg K190368 - Enhanced Feature Software Pack CXDI Series K190368 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k181447/ 2019-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k181447-safety-insulin-needle-for-single-use-fda-510k.jpg K181447 - Safety insulin needle for single use K181447 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Berpu Medical Technology Co., Ltd.. Cleared Mar 2019. https://www.510kdatabase.net/k181610/ 2019-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k181610-activortho-nitinol-compression-screw-fda-510k.jpg K181610 - ActivOrtho Nitinol Compression Screw System K181610 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Activortho, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k182771/ 2019-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k182771-iss-jazz-screw-system-and-jazz-cap-sp-fda-510k.jpg K182771 - ISS-JAZZ Screw System and JAZZ CAP SP K182771 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Implanet, S.A.. Cleared Mar 2019. https://www.510kdatabase.net/k183176/ 2019-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k183176-endotoxin-activity-assay-eaa-fda-510k.jpg K183176 - Endotoxin Activity Assay (EAA) K183176 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Spectral Medical, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k183180/ 2019-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k183180-caiman-5-maryland-fda-510k.jpg K183180 - Caiman 5 Maryland K183180 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k183232/ 2019-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k183232-double-endobutton-fixation-device-fda-510k.jpg K183232 - Double ENDOBUTTON Fixation Device K183232 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith and Nephew, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k183437/ 2019-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k183437-airray-subdural-cortical-electrodes-fda-510k.jpg K183437 - AirRay Subdural Cortical Electrodes K183437 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cortec GmbH. Cleared Mar 2019. https://www.510kdatabase.net/k183440/ 2019-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k183440-cryocheck-fviii-inhibitor-kit-fda-510k.jpg K183440 - CRYOcheck FVIII Inhibitor Kit K183440 is a FDA 510(k) cleared hematology medical device. Manufacturer: Precision Biologic, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k183446/ 2019-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k183446-bioplex-2200-lyme-total-fda-510k.jpg K183446 - BioPlex 2200 Lyme Total K183446 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bio-Rad Laboratories. Cleared Mar 2019. https://www.510kdatabase.net/k183469/ 2019-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k183469-microlife-digital-blood-pressure-monitor-fda-510k.jpg K183469 - Microlife Digital Blood Pressure Monitor K183469 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Microlife Intellectual Property GmbH. Cleared Mar 2019. https://www.510kdatabase.net/k183524/ 2019-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k183524-vitek2-ast-gram-negative-delafloxacin-fda-510k.jpg K183524 - VITEK2 AST-Gram Negative Delafloxacin (<=0.06->=4 ug/mL) K183524 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k183603/ 2019-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k183603-innate-cannulated-screw-system-fda-510k.jpg K183603 - INnate Cannulated Screw System K183603 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exsomed Corporation. Cleared Mar 2019. https://www.510kdatabase.net/k183610/ 2019-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k183610-renuvionj-plasma-precise-handpiece-fda-510k.jpg K183610 - Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open handpieces, Renuvion/J-Plasma Precise Open handpieces K183610 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bovie Medical Corporation. Cleared Mar 2019. https://www.510kdatabase.net/den180017/ 2019-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/den180017-quantra-hemostasis-analyzer-qplus-fda-510k.jpg DEN180017 - Quantra Hemostasis Analyzer, QPlus Cartridge DEN180017 is a FDA 510(k) cleared hematology medical device. Manufacturer: Hemosonics, LLC. Cleared Mar 2019. https://www.510kdatabase.net/k181823/ 2019-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k181823-kardiaai-fda-510k.jpg K181823 - KardiaAI K181823 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: AliveCor, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k182013/ 2019-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k182013-easyinstruments-fda-510k.jpg K182013 - EasyInstruments K182013 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Agency For Medical Innovations GmbH. Cleared Mar 2019. https://www.510kdatabase.net/k182241/ 2019-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k182241-non-sterile-powder-free-nitrile-fda-510k.jpg K182241 - Non-sterile, Powder-Free Nitrile Examination Glove Black Tested for use with Chemotherapy Drugs K182241 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sri Trang Gloves (Thailand) Co., Ltd.. Cleared Mar 2019. https://www.510kdatabase.net/k182313/ 2019-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k182313-bonetrust-implant-system-fda-510k.jpg K182313 - BoneTrust Implant System K182313 is a FDA 510(k) cleared dental medical device. Manufacturer: Medical Instinct Deutschland GmbH. Cleared Mar 2019. https://www.510kdatabase.net/k182553/ 2019-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k182553-inno-pathwire-fda-510k.jpg K182553 - Inno-Pathwire K182553 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Suzhou Innomed Medical Device Co., Ltd.. Cleared Mar 2019. https://www.510kdatabase.net/k182789/ 2019-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k182789-kls-martin-individual-patient-fda-510k.jpg K182789 - KLS Martin Individual Patient Solutions (IPS) Planning System K182789 is a FDA 510(k) cleared dental medical device. Manufacturer: KLS-Martin L.P.. Cleared Mar 2019. https://www.510kdatabase.net/k183236/ 2019-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k183236-rotium-bioresorbable-wick-fda-510k.jpg K183236 - Rotium Bioresorbable Wick K183236 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nanofiber Solutions, LLC. Cleared Mar 2019. https://www.510kdatabase.net/k190253/ 2019-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k190253-evos-small-fragment-upper-extremity-fda-510k.jpg K190253 - EVOS Small Fragment Upper Extremity Plates Line Additions K190253 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k173064/ 2019-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k173064-zapnea-oral-appliance-fda-510k.jpg K173064 - ZAPnea Oral Appliance K173064 is a FDA 510(k) cleared dental medical device. Manufacturer: B. Fareid, Dds, PC. Cleared Mar 2019. https://www.510kdatabase.net/k182537/ 2019-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k182537-radmax-digital-imaging-software-fda-510k.jpg K182537 - RADMAX Digital Imaging Software K182537 is a FDA 510(k) cleared radiology medical device. Manufacturer: DRGEM Corporation. Cleared Mar 2019. https://www.510kdatabase.net/k182799/ 2019-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k182799-arthrex-univers-ii-shoulder-prosthesis-fda-510k.jpg K182799 - Arthrex Univers II Shoulder Prosthesis System: Titanium Humeral Heads K182799 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k182995/ 2019-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k182995-bariatric-power-positioning-system-bpps-fda-510k.jpg K182995 - Bariatric Power Positioning System (BPPS) K182995 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Motion Concepts. Cleared Mar 2019. https://www.510kdatabase.net/k183085/ 2019-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k183085-coredx-pulmonary-mini-forceps-fda-510k.jpg K183085 - CoreDx™ Pulmonary Mini-Forceps K183085 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Boston Scientific Corporation. Cleared Mar 2019. https://www.510kdatabase.net/k183092/ 2019-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k183092-kuros-tlif-cage-fda-510k.jpg K183092 - Kuros TLIF Cage K183092 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Kuros Biosciences B.V. Cleared Mar 2019. https://www.510kdatabase.net/k183177/ 2019-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k183177-nitinol-thermocouple-tcn-electrode-fda-510k.jpg K183177 - Nitinol Thermocouple (TCN) Electrode K183177 is a FDA 510(k) cleared neurology medical device. Manufacturer: Boston Scientific Corporation. Cleared Mar 2019. https://www.510kdatabase.net/k183285/ 2019-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k183285-cmtriage-fda-510k.jpg K183285 - cmTriage K183285 is a FDA 510(k) cleared radiology medical device. Manufacturer: Curemetrix, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k183303/ 2019-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k183303-brainsway-deep-tms-system-fda-510k.jpg K183303 - Brainsway Deep TMS System K183303 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainsway , Ltd.. Cleared Mar 2019. https://www.510kdatabase.net/k183448/ 2019-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k183448-newtom-5g-xl-fda-510k.jpg K183448 - NewTom 5G XL K183448 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cefla S.C.. Cleared Mar 2019. https://www.510kdatabase.net/k190039/ 2019-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k190039-echosure-diagnostic-ultrasound-system-fda-510k.jpg K190039 - EchoSure Diagnostic Ultrasound System K190039 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sonavex, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k190146/ 2019-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k190146-nexus-dr-digital-x-ray-imaging-system-fda-510k.jpg K190146 - Nexus DR Digital X-ray Imaging System K190146 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varex Imaging Corporation. Cleared Mar 2019. https://www.510kdatabase.net/k190153/ 2019-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k190153-radiforce-mx216-fda-510k.jpg K190153 - RadiForce MX216 K190153 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eizo Corporation. Cleared Mar 2019. https://www.510kdatabase.net/k190201/ 2019-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k190201-corus-spinal-system-fda-510k.jpg K190201 - CORUS Spinal System K190201 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Providence Medical Technology, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k190206/ 2019-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k190206-dc-90dc-90sdc-90qdc-95dc-95sdc-88dc-fda-510k.jpg K190206 - DC-90/DC-90S/DC-90Q/DC-95/DC-95S/DC-88/DC-88S/DC-80A/DC-80A Exp/DC-80A Pro/DC-8X/DC-8Q/DC-81/DC-82 Diagnostic Ultrasound System K190206 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Mar 2019. https://www.510kdatabase.net/k190224/ 2019-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k190224-medline-burn-and-wound-dressing-otc-fda-510k.jpg K190224 - Medline Burn and Wound Dressing (OTC) K190224 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medline Industries, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k190256/ 2019-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k190256-rulo-radiofrequency-lesion-probe-fda-510k.jpg K190256 - Rulo Radiofrequency Lesion Probe K190256 is a FDA 510(k) cleared neurology medical device. Manufacturer: Epimed International, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k190276/ 2019-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k190276-provident-ii-hip-stem-fda-510k.jpg K190276 - Provident II Hip Stem K190276 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stelkast, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k173518/ 2019-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k173518-spectrum-spine-expandable-cages-ssec-fda-510k.jpg K173518 - Spectrum Spine Expandable Cages (SSEC) K173518 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spectrum Spine, LLC. Cleared Mar 2019. https://www.510kdatabase.net/k180880/ 2019-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k180880-dari-health-fda-510k.jpg K180880 - DARI Health K180880 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Scientific Analytics, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k181165/ 2019-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k181165-philips-wearable-biosensor-g5-solution-fda-510k.jpg K181165 - Philips wearable biosensor-G5 Solution K181165 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Connected Sensing- A Division of Philips Medical Systems. Cleared Mar 2019. https://www.510kdatabase.net/k182311/ 2019-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k182311-cervella-fda-510k.jpg K182311 - Cervella K182311 is a FDA 510(k) cleared neurology medical device. Manufacturer: Innovative Neurological Devices, LLC. Cleared Mar 2019. https://www.510kdatabase.net/k182344/ 2019-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k182344-rhythmanalytics-fda-510k.jpg K182344 - RhythmAnalytics K182344 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biofourmis Singapore Pte., Ltd.. Cleared Mar 2019. https://www.510kdatabase.net/k182413/ 2019-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k182413-electric-breast-pump-fda-510k.jpg K182413 - Electric Breast Pump K182413 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Guangdong Horigen Mother & Baby Products Co., Ltd.. Cleared Mar 2019. https://www.510kdatabase.net/k182870/ 2019-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k182870-introcan-safety-3-closed-iv-catheter-fda-510k.jpg K182870 - Introcan Safety 3 Closed IV Catheter K182870 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k183078/ 2019-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k183078-vitalconnect-platform-vitalpatch-fda-510k.jpg K183078 - VitalConnect Platform, VitalPatch Biosensor K183078 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vitalconnect, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k183373/ 2019-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k183373-bonebridge-fda-510k.jpg K183373 - Bonebridge K183373 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Med-El Elektromedizinische Geraete GmbH. Cleared Mar 2019. https://www.510kdatabase.net/k183551/ 2019-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k183551-vitek-2-ast-gram-negative-minocycline-fda-510k.jpg K183551 - VITEK 2 AST-Gram Negative Minocycline (<= 0.5 - >= 32 ug/mL) K183551 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k190055/ 2019-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k190055-duo-lumbar-interbody-fusion-device-fda-510k.jpg K190055 - Duo Lumbar Interbody Fusion Device K190055 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spineology, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k190098/ 2019-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k190098-endophys-pressure-sensing-sheath-fda-510k.jpg K190098 - Endophys Pressure Sensing Sheath K190098 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Endophys Holdings, LLC. Cleared Mar 2019. https://www.510kdatabase.net/k190141/ 2019-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k190141-hanarostent-lowax-colonrectum-nnn-fda-510k.jpg K190141 - HANAROSTENT LowAx Colon/Rectum (NNN) K190141 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: M.I. Tech Co., Ltd.. Cleared Mar 2019. https://www.510kdatabase.net/k190184/ 2019-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k190184-isleeve-introducer-set-fda-510k.jpg K190184 - iSLEEVE Introducer Set K190184 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific. Cleared Mar 2019. https://www.510kdatabase.net/k181682/ 2019-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k181682-visulas-green-fda-510k.jpg K181682 - VISULAS green K181682 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Carl Zeiss Meditec, AG. Cleared Mar 2019. https://www.510kdatabase.net/k181807/ 2019-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k181807-solitaire-2-revascularization-device-fda-510k.jpg K181807 - Solitaire 2 Revascularization Device, Solitaire Platinum Revascularization Device (Solitaire Revascularization Device) K181807 is a FDA 510(k) cleared neurology medical device. Manufacturer: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. Cleared Mar 2019. https://www.510kdatabase.net/k181859/ 2019-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k181859-visualase-thermal-therapy-system-fda-510k.jpg K181859 - Visualase Thermal Therapy System K181859 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Navigation, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k182173/ 2019-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k182173-joule-system-fda-510k.jpg K182173 - Joule System K182173 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sciton, Inc. Cleared Mar 2019. https://www.510kdatabase.net/k182966/ 2019-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k182966-planet-onco-dose-fda-510k.jpg K182966 - PLANET Onco Dose K182966 is a FDA 510(k) cleared radiology medical device. Manufacturer: Dosisoft. Cleared Mar 2019. https://www.510kdatabase.net/k183201/ 2019-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k183201-hearing-healthcare-pro-fda-510k.jpg K183201 - Hearing Healthcare Pro K183201 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Db Diagnostic Systems, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k183289/ 2019-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k183289-cleargrasp-snare-fda-510k.jpg K183289 - ClearGrasp Snare K183289 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Finemedix Co., Ltd.. Cleared Mar 2019. https://www.510kdatabase.net/k183366/ 2019-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k183366-genepoc-strep-a-fda-510k.jpg K183366 - GenePOC Strep A K183366 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Genepoc, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k183397/ 2019-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k183397-choicespine-stealth-cervical-spacer-fda-510k.jpg K183397 - ChoiceSpine Stealth Cervical Spacer System K183397 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Choicespine, LP. Cleared Mar 2019. https://www.510kdatabase.net/k180842/ 2019-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k180842-mac-medical-d-series-blanket-and-fda-510k.jpg K180842 - MAC Medical D-Series Blanket and Solution Warming Cabinets K180842 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Mac Medical, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k181656/ 2019-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k181656-adore-polymacon-daily-wear-soft-fda-510k.jpg K181656 - ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/color) K181656 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Eyemed Technologies S.R.L.. Cleared Mar 2019. https://www.510kdatabase.net/k182628/ 2019-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k182628-imagio-ultrasound-imaging-system-fda-510k.jpg K182628 - Imagio Ultrasound Imaging System K182628 is a FDA 510(k) cleared radiology medical device. Manufacturer: Seno Medical Instruments, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k183053/ 2019-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k183053-olympus-small-intestinal-capsule-fda-510k.jpg K183053 - Olympus Small Intestinal Capsule Endoscope System K183053 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Mar 2019. https://www.510kdatabase.net/k183172/ 2019-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k183172-stryker-sternalplate-system-fda-510k.jpg K183172 - Stryker SternalPlate System K183172 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker. Cleared Mar 2019. https://www.510kdatabase.net/k190030/ 2019-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k190030-embrella-endoscopic-distal-attachment-fda-510k.jpg K190030 - Embrella Endoscopic Distal Attachment K190030 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Micro-Tech (Nanjing) Co., Ltd.. Cleared Mar 2019. https://www.510kdatabase.net/k181782/ 2019-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k181782-medline-reinforced-epidural-catheter-fda-510k.jpg K181782 - Medline Reinforced Epidural Catheter K181782 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Medline Industries, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k181843/ 2019-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k181843-mlp-special-locking-bone-plate-system-fda-510k.jpg K181843 - MLP Special Locking Bone Plate System K181843 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Maxxion Medical, LLC / Baumer SA. Cleared Mar 2019. https://www.510kdatabase.net/k182225/ 2019-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k182225-dimension-vista-high-sensitivity-fda-510k.jpg K182225 - Dimension Vista High-Sensitivity Troponin I (TNIH) Assay K182225 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k183384/ 2019-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k183384-jo-agape-original-personal-lubricant-fda-510k.jpg K183384 - JO Agape Original Personal Lubricant, MUSE Essence Water-Based Lubricant, #LubeLife Water-Based Lubricant, #LubeLife Water-Based Anal Lubricant K183384 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: United Consortium. Cleared Mar 2019. https://www.510kdatabase.net/k183453/ 2019-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k183453-vs3-ir-fda-510k.jpg K183453 - VS3-IR K183453 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medtronic. Cleared Mar 2019. https://www.510kdatabase.net/k190193/ 2019-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k190193-spineex-sagittae-lateral-lumbar-fda-510k.jpg K190193 - SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices K190193 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spineex, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k190322/ 2019-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k190322-scarlet-ac-t-secured-anterior-cervical-fda-510k.jpg K190322 - SCARLET® AC-T Secured Anterior Cervical Cage K190322 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spineart. Cleared Mar 2019. https://www.510kdatabase.net/k182495/ 2019-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k182495-electronic-blood-pressure-monitor-fda-510k.jpg K182495 - Electronic Blood Pressure Monitor K182495 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Jumper Medical Equipment Co., Ltd.. Cleared Mar 2019. https://www.510kdatabase.net/k173793/ 2019-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k173793-xacttrace-single-use-respiratory-fda-510k.jpg K173793 - XactTrace Single Use Respiratory Effort Belt System K173793 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Embla Systems. Cleared Mar 2019. https://www.510kdatabase.net/k180050/ 2019-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k180050-curvafix-intramedullary-rodscrew-system-fda-510k.jpg K180050 - CurvaFix Intramedullary Rodscrew System K180050 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Curvafix, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k180852/ 2019-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k180852-manual-wheelchair-fda-510k.jpg K180852 - Manual Wheelchair K180852 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Jiangyin Newrise Medical Equipment Co., Ltd.. Cleared Mar 2019. https://www.510kdatabase.net/k181475/ 2019-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k181475-dxh-520-hematology-instrument-fda-510k.jpg K181475 - DxH 520 Hematology Instrument K181475 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Coulter. Cleared Mar 2019. https://www.510kdatabase.net/k181730/ 2019-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k181730-bd-vacutainer-eclipse-ultrafill-blood-fda-510k.jpg K181730 - BD Vacutainer Eclipse UltraFill Blood Collection Needle K181730 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson and Company. Cleared Mar 2019. https://www.510kdatabase.net/k181788/ 2019-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k181788-lead-free-chemical-indicators-for-fda-510k.jpg K181788 - Lead-free Chemical Indicators for Steam Sterilization K181788 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Kem Medical Products Corp.. Cleared Mar 2019. https://www.510kdatabase.net/k181871/ 2019-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k181871-elia-celikey-igg-immunoassay-fda-510k.jpg K181871 - EliA Celikey IgG Immunoassay K181871 is a FDA 510(k) cleared immunology medical device. Manufacturer: Phadia AB. Cleared Mar 2019. https://www.510kdatabase.net/k181932/ 2019-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k181932-dtx-studio-design-fda-510k.jpg K181932 - DTX Studio design K181932 is a FDA 510(k) cleared dental medical device. Manufacturer: Nobel Biocare AB. Cleared Mar 2019. https://www.510kdatabase.net/k182710/ 2019-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k182710-fetal-doppler-model-fd88-fda-510k.jpg K182710 - Fetal Doppler, Model FD88 K182710 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shenzzhen Luckcome Technology Inc., Ltd.. Cleared Mar 2019. https://www.510kdatabase.net/k182804/ 2019-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k182804-traditional-length-gj-feeding-device-fda-510k.jpg K182804 - Traditional Length GJ Feeding Device K182804 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Applied Medical Technology, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k182822/ 2019-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k182822-guardian-angel-rx-ga-1001-digital-fda-510k.jpg K182822 - Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System K182822 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Taiwan Aulisa Medical Devices Technologies, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k183067/ 2019-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k183067-guardian-angel-rx-ga2000-digital-vital-fda-510k.jpg K183067 - Guardian Angel Rx GA2000 Digital Vital Sign Monitoring System K183067 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Taiwan Aulisa Medical Devices Technologies, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k183147/ 2019-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k183147-brackfix-fda-510k.jpg K183147 - BrackFix K183147 is a FDA 510(k) cleared dental medical device. Manufacturer: Voco GmbH. Cleared Mar 2019. https://www.510kdatabase.net/k183259/ 2019-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k183259-idys-tlif-tivac-fda-510k.jpg K183259 - Idys™ TLIF TiVac K183259 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Clariance, Sas. Cleared Mar 2019. https://www.510kdatabase.net/k183266/ 2019-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k183266-ep-tracer-system-fda-510k.jpg K183266 - EP-TRACER System K183266 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Schwarzer Cardiotek GmbH. Cleared Mar 2019. https://www.510kdatabase.net/k183401/ 2019-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k183401-vis-u-all-low-temperature-fda-510k.jpg K183401 - Vis-U-All Low Temperature Sterilization Pouch/Tubing K183401 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Mar 2019. https://www.510kdatabase.net/k183402/ 2019-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k183402-pro-lite-sterilization-tray-fda-510k.jpg K183402 - PRO-LITE Sterilization Tray K183402 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Mar 2019. https://www.510kdatabase.net/k183478/ 2019-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k183478-clearon-mobile-fda-510k.jpg K183478 - ClearON Mobile K183478 is a FDA 510(k) cleared radiology medical device. Manufacturer: Rayence Co., Ltd.. Cleared Mar 2019. https://www.510kdatabase.net/k183690/ 2019-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k183690-tenodesis-screw-system-fda-510k.jpg K183690 - Tenodesis Screw System K183690 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paragon 28, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k183702/ 2019-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k183702-polar-care-wave-fda-510k.jpg K183702 - Polar Care Wave K183702 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Breg, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k183705/ 2019-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k183705-identiti-porous-ti-interbody-system-fda-510k.jpg K183705 - IdentiTi Porous Ti Interbody System K183705 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k190007/ 2019-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k190007-vydence-laser-family-fda-510k.jpg K190007 - Vydence Laser Family K190007 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Vydence Medical Industria E Comercio Ltda. Cleared Mar 2019. https://www.510kdatabase.net/k190234/ 2019-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k190234-odi-hd-dental-sensor-fda-510k.jpg K190234 - ODI HD Dental Sensor K190234 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cnd Global Technologies, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/den180021/ 2019-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/den180021-early-bird-bleed-monitoring-system-fda-510k.jpg DEN180021 - Early Bird Bleed Monitoring System DEN180021 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Saranas, Inc.. Cleared Mar 2019. https://www.510kdatabase.net/k180479/ 2019-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k180479-reds-system-fda-510k.jpg K180479 - ReDS System K180479 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sensible Medical Innovations , Ltd.. Cleared Feb 2019. https://www.510kdatabase.net/k181528/ 2019-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k181528-austin-miller-large-external-fixation-fda-510k.jpg K181528 - Austin Miller Large External Fixation System K181528 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Austin Miller Trauma, LLC. Cleared Feb 2019. https://www.510kdatabase.net/k182250/ 2019-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k182250-solero-mta-cart-solero-mta-system-fda-510k.jpg K182250 - Solero MTA Cart, Solero MTA System, Solero microwave Tissue Ablation Applicator (14cm), , Solero microwave Tissue Ablation Applicator (19cm), Solero microwave Tissue Ablation Applicator (29cm) K182250 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: AngioDynamics, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k182629/ 2019-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k182629-digital-thermometer-fda-510k.jpg K182629 - Digital Thermometer K182629 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Joytech Healthcare Co. , Ltd.. Cleared Feb 2019. https://www.510kdatabase.net/k182839/ 2019-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k182839-lifetech-cardio-model-8301-temporary-fda-510k.jpg K182839 - Lifetech Cardio Model 8301 Temporary Pacemaker K182839 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.. Cleared Feb 2019. https://www.510kdatabase.net/k183099/ 2019-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k183099-quantien-measurement-system-fda-510k.jpg K183099 - QUANTIEN Measurement System K183099 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: St. Jude Medical (Now Abbott Medical). Cleared Feb 2019. https://www.510kdatabase.net/k183313/ 2019-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k183313-euroimmun-anti-tissue-transglutaminase-fda-510k.jpg K183313 - EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue Transglutaminase ELISA (IgG) K183313 is a FDA 510(k) cleared immunology medical device. Manufacturer: Euroimmun Us, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k183686/ 2019-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k183686-fujifilm-endoscope-model-eg-530n-fda-510k.jpg K183686 - FUJIFILM Endoscope Model EG-530N K183686 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fujifilm Corporation. Cleared Feb 2019. https://www.510kdatabase.net/k180682/ 2019-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k180682-aeropro-cordless-prophy-system-fda-510k.jpg K180682 - AeroPro Cordless Prophy System K180682 is a FDA 510(k) cleared dental medical device. Manufacturer: Premier Dental Company Products. Cleared Feb 2019. https://www.510kdatabase.net/k182003/ 2019-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k182003-lympha-press-optimal-plus-fda-510k.jpg K182003 - Lympha Press Optimal Plus K182003 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Mego Afek AC , Ltd.. Cleared Feb 2019. https://www.510kdatabase.net/k182267/ 2019-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k182267-pat-pain-alleviation-technologies-fda-510k.jpg K182267 - PAT (Pain Alleviation Technologies) K182267 is a FDA 510(k) cleared neurology medical device. Manufacturer: Marchan Medical, LLC. Cleared Feb 2019. https://www.510kdatabase.net/k182494/ 2019-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k182494-flowmet-r-fda-510k.jpg K182494 - FlowMet-R K182494 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Laser Associated Sciences, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k183014/ 2019-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k183014-upmr-790-fda-510k.jpg K183014 - uPMR 790 K183014 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Feb 2019. https://www.510kdatabase.net/k183683/ 2019-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k183683-fujifilm-double-balloon-endoscopes-en-fda-510k.jpg K183683 - FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5 K183683 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fujifilm Corporation. Cleared Feb 2019. https://www.510kdatabase.net/k190087/ 2019-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k190087-ezdent-i-e2-prora-view-fda-510k.jpg K190087 - EzDent-i / E2 / Prora View K190087 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ewoosoft Co., Ltd.. Cleared Feb 2019. https://www.510kdatabase.net/k190155/ 2019-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k190155-fibermarx-radiopaque-tissue-marker-fda-510k.jpg K190155 - FibermarX Radiopaque Tissue Marker K190155 is a FDA 510(k) cleared radiology medical device. Manufacturer: Viscus Biologics, LLC. Cleared Feb 2019. https://www.510kdatabase.net/k181870/ 2019-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k181870-infusion-sets-with-precision-filter-fda-510k.jpg K181870 - Infusion Sets with Precision Filter for Single Use, Precision Infusion Filter for Single Use, Extended Infusion Sets for Single Use K181870 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wuhan W.E.O Science & Technology Development Co., Ltd.. Cleared Feb 2019. https://www.510kdatabase.net/k182052/ 2019-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k182052-omni-instrument-tray-fda-510k.jpg K182052 - Omni Instrument Tray K182052 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hologic, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k182440/ 2019-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k182440-body-system-fda-510k.jpg K182440 - Body System K182440 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: A-1 Engineering. Cleared Feb 2019. https://www.510kdatabase.net/k182941/ 2019-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k182941-healix-advance-sp-peek-anchor-fda-510k.jpg K182941 - HEALIX ADVANCE SP PEEK Anchor K182941 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International SARL. Cleared Feb 2019. https://www.510kdatabase.net/k183211/ 2019-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k183211-3m-comply-hydrogen-peroxide-chemical-fda-510k.jpg K183211 - 3M Comply Hydrogen Peroxide Chemical Indicator K183211 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Feb 2019. https://www.510kdatabase.net/k183360/ 2019-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k183360-vitek-2-ast-gram-negative-fda-510k.jpg K183360 - VITEK 2 AST-Gram Negative Meropenem/Vaborbactam (<=0.5/8 – >=64/8 µg/mL) K183360 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k183374/ 2019-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k183374-grayduck-stent-fda-510k.jpg K183374 - GrayDuck Stent K183374 is a FDA 510(k) cleared radiology medical device. Manufacturer: Poll Medical, LLC. Cleared Feb 2019. https://www.510kdatabase.net/k183454/ 2019-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k183454-tyece-otc-ems-system-fda-510k.jpg K183454 - Tyece OTC EMS System K183454 is a FDA 510(k) cleared neurology medical device. Manufacturer: Tyece , Ltd.. Cleared Feb 2019. https://www.510kdatabase.net/k190356/ 2019-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k190356-clarifix-fda-510k.jpg K190356 - ClariFix K190356 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Arrinex, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k182976/ 2019-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k182976-springtms-fda-510k.jpg K182976 - SpringTMS K182976 is a FDA 510(k) cleared neurology medical device. Manufacturer: Eneura, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k183179/ 2019-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k183179-capere-thrombectomy-system-fda-510k.jpg K183179 - CAPERE Thrombectomy System K183179 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vascular Medcure, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k183290/ 2019-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k183290-bashir-endovascular-catheter-model-fda-510k.jpg K183290 - Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200 K183290 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Thrombolex, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k183698/ 2019-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k183698-zap-x-radiosurgery-system-fda-510k.jpg K183698 - Zap-X Radiosurgery System K183698 is a FDA 510(k) cleared radiology medical device. Manufacturer: Zap Surgical Systems. Cleared Feb 2019. https://www.510kdatabase.net/k190071/ 2019-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k190071-perla-posterior-cervico-thoracic-fda-510k.jpg K190071 - Perla® Posterior Cervico-Thoracic Fixation System K190071 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spineart. Cleared Feb 2019. https://www.510kdatabase.net/k190151/ 2019-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k190151-cobra-fusion-ablation-system-fda-510k.jpg K190151 - COBRA Fusion Ablation System K190151 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: AtriCure, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k181310/ 2019-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k181310-heartcheck-cardi-beat-ecg-monitor-with-fda-510k.jpg K181310 - HeartCheck Cardi Beat ECG Monitor with GEMS Mobile K181310 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cardiocomm Solutions, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k181551/ 2019-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k181551-david-one-step-home-use-pregnancy-test-fda-510k.jpg K181551 - DAVID One Step Home Use Pregnancy Test Midstream, DAVID One Step Home Use Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Strip, DAVID One Step Prescription Pregnancy Test Cassette, DAVID One Step Home Use Pregnancy Test Cassette K181551 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Runbio Biotech Co.,Ltd. Cleared Feb 2019. https://www.510kdatabase.net/k182406/ 2019-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k182406-altus-spine-interbody-fusion-system-fda-510k.jpg K182406 - Altus Spine Interbody Fusion System K182406 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Altus Partners, LLC. Cleared Feb 2019. https://www.510kdatabase.net/k182488/ 2019-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k182488-reprocessed-response-diagnostic-fda-510k.jpg K182488 - Reprocessed Response Diagnostic Electrophysiology Catheter K182488 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Innovative Health, LLC. Cleared Feb 2019. https://www.510kdatabase.net/k182542/ 2019-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k182542-the-epad-2-system-fda-510k.jpg K182542 - The EPAD 2 System K182542 is a FDA 510(k) cleared neurology medical device. Manufacturer: Safeop Surgical, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k182643/ 2019-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k182643-iris-10-system-fda-510k.jpg K182643 - IRIS 1.0 System K182643 is a FDA 510(k) cleared radiology medical device. Manufacturer: Intuitive Surgical. Cleared Feb 2019. https://www.510kdatabase.net/k182825/ 2019-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k182825-fujifilm-ultrasonic-endoscope-fda-510k.jpg K182825 - FUJIFILM Ultrasonic Endoscope K182825 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Fujifilm Corporation. Cleared Feb 2019. https://www.510kdatabase.net/k182859/ 2019-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k182859-babyleo-tn500-fda-510k.jpg K182859 - Babyleo TN500 K182859 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Dragerwerk AG & CO Kgaa. Cleared Feb 2019. https://www.510kdatabase.net/k183240/ 2019-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k183240-empower-rf-catheter-fda-510k.jpg K183240 - Empower RF Catheter K183240 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Broncus Medical, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k183365/ 2019-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k183365-libertas-acetabular-hooded-liner-fda-510k.jpg K183365 - Libertas Acetabular Hooded Liner K183365 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Maxx Orthopedics, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k183588/ 2019-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k183588-choice-spine-hawkeye-vertebral-body-fda-510k.jpg K183588 - Choice Spine Hawkeye Vertebral Body Replacement (VBR) System K183588 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Choicespine. Cleared Feb 2019. https://www.510kdatabase.net/k183621/ 2019-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k183621-emma-15t-mri-system-fda-510k.jpg K183621 - EMMA 1.5T MRI System K183621 is a FDA 510(k) cleared radiology medical device. Manufacturer: Time Medical Limited. Cleared Feb 2019. https://www.510kdatabase.net/k183640/ 2019-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k183640-cellvizio-100-series-confocal-laser-fda-510k.jpg K183640 - Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes K183640 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Mauna Kea Technologies. Cleared Feb 2019. https://www.510kdatabase.net/k183693/ 2019-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k183693-doctor-tecar-fda-510k.jpg K183693 - Doctor Tecar K183693 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Mectronic Medicale S.R.L.. Cleared Feb 2019. https://www.510kdatabase.net/k173418/ 2019-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k173418-nobelparallel-conical-connection-fda-510k.jpg K173418 - NobelParallel Conical Connection K173418 is a FDA 510(k) cleared dental medical device. Manufacturer: Nobel Biocare AB. Cleared Feb 2019. https://www.510kdatabase.net/k182578/ 2019-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k182578-devon-62-deep-vein-thrombosis-dvt-fda-510k.jpg K182578 - Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device K182578 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Devon Medical Products (Jiangsu), Ltd.. Cleared Feb 2019. https://www.510kdatabase.net/k182641/ 2019-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k182641-sensus-iort-system-fda-510k.jpg K182641 - Sensus IORT System K182641 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sensus Healthcare, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k182665/ 2019-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k182665-sensus-tps-workstation-fda-510k.jpg K182665 - Sensus TPS Workstation K182665 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sensus Healthcare, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k183255/ 2019-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k183255-coag-sense-prothrombin-time-pt-inr-fda-510k.jpg K183255 - Coag-Sense Prothrombin Time (PT) / INR Monitoring Device K183255 is a FDA 510(k) cleared hematology medical device. Manufacturer: Coagusense, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k183279/ 2019-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k183279-healix-ti-anchor-with-dynacord-fda-510k.jpg K183279 - HEALIX Ti ANCHOR with DYNACORD K183279 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International SARL. Cleared Feb 2019. https://www.510kdatabase.net/k190105/ 2019-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k190105-zoom-aspiration-pump-fda-510k.jpg K190105 - ZOOM Aspiration Pump K190105 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Taiwan Biomaterial Co., Ltd.. Cleared Feb 2019. https://www.510kdatabase.net/k190255/ 2019-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k190255-sensus-healthcare-tvm-balloon-applicator-fda-510k.jpg K190255 - Sensus Healthcare TVM Balloon Applicator K190255 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sensus Healthcare, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k180953/ 2019-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k180953-anycheck-imt-100-fda-510k.jpg K180953 - AnyCheck IMT-100 K180953 is a FDA 510(k) cleared dental medical device. Manufacturer: Dms Co., Ltd.. Cleared Feb 2019. https://www.510kdatabase.net/k181989/ 2019-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k181989-mridian-linac-system-fda-510k.jpg K181989 - MRIdian Linac System K181989 is a FDA 510(k) cleared radiology medical device. Manufacturer: Viewray, Incorporated. Cleared Feb 2019. https://www.510kdatabase.net/k183415/ 2019-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k183415-vitek-2-ast-gram-negative-imipenem-025-fda-510k.jpg K183415 - VITEK 2 AST-Gram Negative Imipenem (</=0.25->= 16 ug/mL) K183415 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k180346/ 2019-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k180346-byte-aligner-system-fda-510k.jpg K180346 - Byte Aligner System K180346 is a FDA 510(k) cleared dental medical device. Manufacturer: Straight Smile, LLC. Cleared Feb 2019. https://www.510kdatabase.net/k181409/ 2019-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k181409-pressure-therapy-system-pt1003-fda-510k.jpg K181409 - Pressure Therapy System PT1003 K181409 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Xiamen Senyang Co., Ltd.. Cleared Feb 2019. https://www.510kdatabase.net/k181872/ 2019-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k181872-mis-bunion-system-fda-510k.jpg K181872 - MIS Bunion System K181872 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Crossroads Extremity Systems, LLC. Cleared Feb 2019. https://www.510kdatabase.net/k183055/ 2019-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k183055-vector-hammertoe-correction-system-fda-510k.jpg K183055 - Vector Hammertoe Correction System K183055 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nvision Biomedical Technologies, LLC. Cleared Feb 2019. https://www.510kdatabase.net/k183241/ 2019-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k183241-brainscope-tbi-model-ahead-400-fda-510k.jpg K183241 - BrainScope TBI (Model: Ahead 400) K183241 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainscope Company, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k183594/ 2019-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k183594-laparoscopic-curved-spatula-electrode-fda-510k.jpg K183594 - Laparoscopic Curved Spatula Electrode, Retractable, Aspiration Hole, 28cm K183594 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: New Deantronics Taiwan , Ltd.. Cleared Feb 2019. https://www.510kdatabase.net/k182768/ 2019-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k182768-tms-cobot-ts-mv-fda-510k.jpg K182768 - TMS-Cobot TS MV K182768 is a FDA 510(k) cleared neurology medical device. Manufacturer: Axilum Robotics. Cleared Feb 2019. https://www.510kdatabase.net/k180509/ 2019-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k180509-quo-test-a1c-system-fda-510k.jpg K180509 - Quo-Test A1c System K180509 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Ekf Diagnostic GmbH. Cleared Feb 2019. https://www.510kdatabase.net/k181163/ 2019-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k181163-wus-powered-wheelchair-fda-510k.jpg K181163 - Wu's Powered Wheelchair K181163 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Wu'S Tech Co., Ltd.. Cleared Feb 2019. https://www.510kdatabase.net/k181362/ 2019-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k181362-tema-elbow-system-fda-510k.jpg K181362 - TEMA Elbow System K181362 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Lima Corporate S.P.A.. Cleared Feb 2019. https://www.510kdatabase.net/k183546/ 2019-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k183546-gem-premier-chemstat-fda-510k.jpg K183546 - GEM Premier ChemSTAT K183546 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Feb 2019. https://www.510kdatabase.net/k183549/ 2019-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k183549-gem-premier-chemstat-fda-510k.jpg K183549 - GEM Premier ChemSTAT K183549 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Feb 2019. https://www.510kdatabase.net/k183555/ 2019-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k183555-gem-premier-chemstat-fda-510k.jpg K183555 - GEM Premier ChemSTAT K183555 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Feb 2019. https://www.510kdatabase.net/k183704/ 2019-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k183704-rx-1-rhythm-express-remote-cardiac-fda-510k.jpg K183704 - RX-1 Rhythm Express Remote Cardiac Monitoring System K183704 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vivaquant, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k173937/ 2019-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k173937-spirosphere-fda-510k.jpg K173937 - SpiroSphere K173937 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Eresearchtechnology GmbH. Cleared Feb 2019. https://www.510kdatabase.net/k181194/ 2019-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k181194-smartmouth-drymouth-oral-rinse-fda-510k.jpg K181194 - SmartMouth DryMouth Oral Rinse K181194 is a FDA 510(k) cleared dental medical device. Manufacturer: Triumph Pharmaceuticals, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k181353/ 2019-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k181353-lunderquist-fixed-core-wire-guide-fda-510k.jpg K181353 - Lunderquist® Fixed Core Wire Guide K181353 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Feb 2019. https://www.510kdatabase.net/k181393/ 2019-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k181393-empty-eva-bag-models-fvm0134bp-fda-510k.jpg K181393 - Empty Eva Bag, models FVM0134BP, FVM0135BP, FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, FVM0140BP, FVM0141BP K181393 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Valmed S.R.L.. Cleared Feb 2019. https://www.510kdatabase.net/k181507/ 2019-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k181507-prevena-restortm-incision-management-fda-510k.jpg K181507 - PREVENA RESTOR(TM) Incision Management System K181507 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Kci USA, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k181534/ 2019-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k181534-cirrus-hd-oct-fda-510k.jpg K181534 - CIRRUS HD-OCT K181534 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Carl Zeiss Meditec, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k182293/ 2019-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k182293-osseone-dental-implant-system-fda-510k.jpg K182293 - OsseOne Dental Implant System K182293 is a FDA 510(k) cleared dental medical device. Manufacturer: Synoross Dba Osseone. Cleared Feb 2019. https://www.510kdatabase.net/k182332/ 2019-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k182332-phantommsk-fda-510k.jpg K182332 - PhantomMSK K182332 is a FDA 510(k) cleared radiology medical device. Manufacturer: OrthoGrid Systems, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k182932/ 2019-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k182932-rs85-diagnostic-ultrasound-system-fda-510k.jpg K182932 - RS85 Diagnostic Ultrasound System K182932 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Medison Co., Ltd.. Cleared Feb 2019. https://www.510kdatabase.net/k183039/ 2019-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k183039-reunion-reversible-fracture-system-rfx-fda-510k.jpg K183039 - ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) K183039 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker GmbH. Cleared Feb 2019. https://www.510kdatabase.net/k183049/ 2019-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k183049-reliance-lumbar-ibf-system-fda-510k.jpg K183049 - Reliance Lumbar IBF System K183049 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Reliance Medical Systems, LLC. Cleared Feb 2019. https://www.510kdatabase.net/k183072/ 2019-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k183072-endoflip-system-fda-510k.jpg K183072 - EndoFLIP System K183072 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Crospon, Ltd.. Cleared Feb 2019. https://www.510kdatabase.net/k183209/ 2019-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k183209-3m-comply-hydrogen-peroxide-indicator-fda-510k.jpg K183209 - 3M Comply Hydrogen Peroxide Indicator Tape K183209 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Feb 2019. https://www.510kdatabase.net/k183217/ 2019-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k183217-ipl-hair-removal-device-fda-510k.jpg K183217 - IPL Hair Removal Device K183217 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.. Cleared Feb 2019. https://www.510kdatabase.net/k183222/ 2019-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k183222-magnetom-terra-fda-510k.jpg K183222 - MAGNETOM Terra K183222 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k183225/ 2019-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k183225-stabil-orthopaedic-solutions-total-fda-510k.jpg K183225 - Stabil Orthopaedic Solutions Total Knee System K183225 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stabil Orthopaedic Solutions, LLC. Cleared Feb 2019. https://www.510kdatabase.net/k183324/ 2019-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k183324-sensititre-20-24-hour-haemophilus-fda-510k.jpg K183324 - Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.008 - 32 ug/mL K183324 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Thermo Fisher Scientific. Cleared Feb 2019. https://www.510kdatabase.net/k183556/ 2019-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k183556-ocare-wrist-pulse-oximeter-fda-510k.jpg K183556 - oCare Wrist Pulse Oximeter K183556 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Taiwan Biophotonic Corporation. Cleared Feb 2019. https://www.510kdatabase.net/k190138/ 2019-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k190138-magnetom-aera-fda-510k.jpg K190138 - MAGNETOM Aera K190138 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k181315/ 2019-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k181315-antimicrobial-gauze-sponge-dressing-fda-510k.jpg K181315 - Antimicrobial gauze sponge dressing, Antimicrobial super sponge dressing, Antimicrobial non-woven sponge dressing K181315 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Winner Medical Co., Ltd.. Cleared Feb 2019. https://www.510kdatabase.net/k181930/ 2019-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k181930-gmc-wrist-automatic-blood-pressure-fda-510k.jpg K181930 - GMC Wrist Automatic Blood Pressure Monitor K181930 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Gmc, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k182188/ 2019-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k182188-ion-endoluminal-system-fda-510k.jpg K182188 - Ion Endoluminal System K182188 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Intuitive Surgical. Cleared Feb 2019. https://www.510kdatabase.net/k182677/ 2019-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k182677-dynanail-mini-fda-510k.jpg K182677 - DynaNail Mini K182677 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: MedShape, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k182705/ 2019-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k182705-juveno-hip-system-femoral-stem-b-one-fda-510k.jpg K182705 - Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups K182705 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: B-One Ortho, Corp.. Cleared Feb 2019. https://www.510kdatabase.net/k182756/ 2019-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k182756-myostrain-51-fda-510k.jpg K182756 - MyoStrain 5.1 K182756 is a FDA 510(k) cleared radiology medical device. Manufacturer: Myocardial Solutions. Cleared Feb 2019. https://www.510kdatabase.net/k183063/ 2019-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k183063-ingenia-ingenia-cx-ingenia-elition-and-fda-510k.jpg K183063 - Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems K183063 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Feb 2019. https://www.510kdatabase.net/k183083/ 2019-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k183083-shoreline-cervical-interbody-rt-system-fda-510k.jpg K183083 - Shoreline Cervical Interbody RT System K183083 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared Feb 2019. https://www.510kdatabase.net/k183196/ 2019-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k183196-stryker-navigation-system-with-fda-510k.jpg K183196 - Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask Tracker K183196 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Corporation. Cleared Feb 2019. https://www.510kdatabase.net/k183206/ 2019-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k183206-dexcom-g6-continuous-glucose-fda-510k.jpg K183206 - Dexcom G6 Continuous Glucose Monitoring System K183206 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dexcom, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k183221/ 2019-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k183221-magnetom-amira-magnetom-sempra-fda-510k.jpg K183221 - MAGNETOM Amira, MAGNETOM Sempra K183221 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k183317/ 2019-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k183317-advantagerib-system-fda-510k.jpg K183317 - AdvantageRib System K183317 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Sig Medical Corporation. Cleared Feb 2019. https://www.510kdatabase.net/k183506/ 2019-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k183506-healix-advance-anchor-with-dynacord-fda-510k.jpg K183506 - HEALIX ADVANCE Anchor with DYNACORD Suture K183506 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International SARL. Cleared Feb 2019. https://www.510kdatabase.net/k183569/ 2019-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k183569-dd-cube-one-ml-fda-510k.jpg K183569 - DD cube ONE ML K183569 is a FDA 510(k) cleared dental medical device. Manufacturer: Dental Direkt GmbH. Cleared Feb 2019. https://www.510kdatabase.net/k183635/ 2019-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k183635-photofix-decellularized-bovine-fda-510k.jpg K183635 - PhotoFix Decellularized Bovine Pericardium K183635 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cryolife, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k190074/ 2019-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k190074-presero-3d-scanning-system-fda-510k.jpg K190074 - Presero 3D Scanning System K190074 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Certis Health. Cleared Feb 2019. https://www.510kdatabase.net/den180058/ 2019-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/den180058-tslim-x2-insulin-pump-with-fda-510k.jpg DEN180058 - t:slim X2 insulin pump with interoperable technology DEN180058 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Tandem Diabetes Care, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k181508/ 2019-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k181508-uu-blood-collection-sets-fda-510k.jpg K181508 - U&U Blood Collection Sets K181508 is a FDA 510(k) cleared general hospital medical device. Manufacturer: U&U Medical Technology Co, Ltd.. Cleared Feb 2019. https://www.510kdatabase.net/k181661/ 2019-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k181661-qxdx-bcr-abl-is-kit-for-use-on-the-fda-510k.jpg K181661 - QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System K181661 is a FDA 510(k) cleared medical genetics medical device. Manufacturer: Bio-Rad Laboratories, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k182661/ 2019-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k182661-kava-and-kava-with-herbst-fda-510k.jpg K182661 - Kava and Kava with Herbst K182661 is a FDA 510(k) cleared dental medical device. Manufacturer: Sketchpad Innovations, LLC. Cleared Feb 2019. https://www.510kdatabase.net/k182874/ 2019-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k182874-fenom-pro-nitric-oxide-test-fda-510k.jpg K182874 - Fenom Pro Nitric Oxide Test K182874 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Spirosure, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k182915/ 2019-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k182915-envizion-medical-envue-fda-510k.jpg K182915 - ENvizion Medical ENvue K182915 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Envizion Medical , Ltd.. Cleared Feb 2019. https://www.510kdatabase.net/k182974/ 2019-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k182974-nuvasive-reline-system-fda-510k.jpg K182974 - NuVasive Reline System K182974 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Feb 2019. https://www.510kdatabase.net/k182991/ 2019-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k182991-epic-extremity-fusion-plate-system-fda-510k.jpg K182991 - EPIC Extremity Fusion Plate System K182991 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Epic Extremity, LLC. Cleared Feb 2019. https://www.510kdatabase.net/k183161/ 2019-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k183161-snapshot-freeze-2-fda-510k.jpg K183161 - SnapShot Freeze 2 K183161 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems, LLC. Cleared Feb 2019. https://www.510kdatabase.net/k181955/ 2019-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k181955-wiemspro-fda-510k.jpg K181955 - WiEMSpro K181955 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Medical Cables S.L.. Cleared Feb 2019. https://www.510kdatabase.net/k182934/ 2019-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k182934-fora-p100-blood-pressure-monitoring-fda-510k.jpg K182934 - FORA P100 Blood Pressure Monitoring System K182934 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Taidoc Technology Corporation. Cleared Feb 2019. https://www.510kdatabase.net/k183127/ 2019-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k183127-microscan-dried-gram-negative-miccombo-fda-510k.jpg K183127 - MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam (0.03/8-64/8ug/mL) K183127 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k183167/ 2019-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k183167-boston-es-enflufocon-a-rigid-gas-fda-510k.jpg K183167 - Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens K183167 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Bausch & Lomb, Incorporated. Cleared Feb 2019. https://www.510kdatabase.net/k183375/ 2019-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k183375-yumizen-c1200-yumizen-c1200-glucose-hk-fda-510k.jpg K183375 - Yumizen C1200, Yumizen C1200 Glucose HK, Sodium Electrode, Potassium Electrode, Chloride Electrode K183375 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Horiba, Ltd.. Cleared Feb 2019. https://www.510kdatabase.net/k183637/ 2019-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k183637-cruxcan-crx-1000-fda-510k.jpg K183637 - Cruxcan (CRX-1000) K183637 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cruxell Corp.. Cleared Feb 2019. https://www.510kdatabase.net/k190056/ 2019-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k190056-kowa-vk-2s-fda-510k.jpg K190056 - KOWA VK-2s K190056 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Kowa Co. Ltd. Chofu. Cleared Feb 2019. https://www.510kdatabase.net/k190075/ 2019-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k190075-aurora-evacuator-fda-510k.jpg K190075 - Aurora Evacuator K190075 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Rebound Therapeutics. Cleared Feb 2019. https://www.510kdatabase.net/k180691/ 2019-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k180691-truedorsal-devices-fda-510k.jpg K180691 - TrueDorsal Devices K180691 is a FDA 510(k) cleared dental medical device. Manufacturer: True Function Laboratory, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k181340/ 2019-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k181340-cemented-tsi-hip-stem-fda-510k.jpg K181340 - Cemented TSI Hip Stem K181340 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Signature Orthopaedics Pty, Ltd.. Cleared Feb 2019. https://www.510kdatabase.net/k183073/ 2019-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k183073-smg-anterior-cervical-plate-system-fda-510k.jpg K183073 - SMG Anterior Cervical Plate System K183073 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Sapphire Medical Group. Cleared Feb 2019. https://www.510kdatabase.net/k183166/ 2019-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k183166-bactalert-fa-plus-fda-510k.jpg K183166 - BacT/ALERT FA Plus K183166 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k183396/ 2019-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k183396-hanarostent-fasttm-biliary-nnn-fda-510k.jpg K183396 - HANAROSTENT FASTTM Biliary (NNN) K183396 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: M.I. Tech Co., Ltd.. Cleared Feb 2019. https://www.510kdatabase.net/k183409/ 2019-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k183409-athena-ii-cervical-plate-system-fda-510k.jpg K183409 - Athena II Cervical Plate System K183409 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medyssey USA, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k183477/ 2019-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k183477-easypphtm-hemorrhoidal-stapler-for-fda-510k.jpg K183477 - easyPPHTM Hemorrhoidal Stapler for Single Use K183477 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ezisurg Medical Co., Ltd.. Cleared Feb 2019. https://www.510kdatabase.net/k183557/ 2019-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k183557-endoskeleton-ta-interbody-fusion-fda-510k.jpg K183557 - Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TO Interbody Fusion Device, Endoskeleton® TT Interbody Fusion Device, Endoskeleton® TC Interbody Fusion Device, Endoskeleton® TCS Interbody Fusion Device, Endoskeleton® TL Interbody Fusion Device, Endoskeleton® TA Vertebral Body Replacement (VBR) Device K183557 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Titan Spine, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k183585/ 2019-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k183585-elitone-device-fda-510k.jpg K183585 - Elitone Device K183585 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Elidah, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k190078/ 2019-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k190078-intrasight-fda-510k.jpg K190078 - IntraSight K190078 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Volcano Corporation. Cleared Feb 2019. https://www.510kdatabase.net/k190085/ 2019-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k190085-journey-ii-unicompartmental-knee-system-fda-510k.jpg K190085 - Journey II Unicompartmental Knee System K190085 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k180835/ 2019-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k180835-sekure-acetaminophen-l3k-assay-fda-510k.jpg K180835 - SEKURE Acetaminophen L3K Assay K180835 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Sekisui Diagnostics P.E.I., Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k181143/ 2019-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k181143-keeler-tonocare-tonometer-fda-510k.jpg K181143 - Keeler TonoCare Tonometer K181143 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Keeler Instruments, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k181317/ 2019-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k181317-fusion-cytology-brush-cytomax-ii-fda-510k.jpg K181317 - Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush K181317 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Wilson-Cook Medical, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k181467/ 2019-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k181467-microstream-luer-adult-pediatric-fda-510k.jpg K181467 - Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter Line K181467 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Oridion Medical 1987 , Ltd.. Cleared Feb 2019. https://www.510kdatabase.net/k182040/ 2019-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k182040-coala-heart-monitor-fda-510k.jpg K182040 - Coala Heart Monitor K182040 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Coala Life AB. Cleared Feb 2019. https://www.510kdatabase.net/k182833/ 2019-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k182833-argenz-liquid-shade-argenz-incisal-fda-510k.jpg K182833 - ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer K182833 is a FDA 510(k) cleared dental medical device. Manufacturer: The Argen Corporation. Cleared Feb 2019. https://www.510kdatabase.net/k183141/ 2019-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k183141-link-mp-monoblock-hip-prosthesis-fda-510k.jpg K183141 - LINK MP Monoblock Hip Prosthesis K183141 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Waldemar Link GmbH & Co. KG. Cleared Feb 2019. https://www.510kdatabase.net/k183186/ 2019-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k183186-head-coil-12-head-coil-32-carotid-coil-fda-510k.jpg K183186 - Head Coil – 12, Head Coil – 32, Carotid Coil – 8, Temporomandibular Joint Coil – 4, Infant Coil – 24, Cardiac Coil – 24, Foot & Ankle Coil - 24 K183186 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Feb 2019. https://www.510kdatabase.net/k183245/ 2019-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k183245-carestream-drx-1-system-with-drx-plus-fda-510k.jpg K183245 - Carestream DRX-1 System with DRX Plus 2530 Detectors K183245 is a FDA 510(k) cleared radiology medical device. Manufacturer: Carestream Health, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k183517/ 2019-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k183517-ammonia-ii-fda-510k.jpg K183517 - Ammonia II K183517 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Operations (Rdo). Cleared Feb 2019. https://www.510kdatabase.net/k181577/ 2019-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k181577-acqmap-high-resolution-imaging-and-fda-510k.jpg K181577 - AcQMap High Resolution Imaging and Mapping System K181577 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Acutus Medical, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k182224/ 2019-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k182224-safeair-smoke-evacuator-compact-fda-510k.jpg K182224 - SafeAir Smoke Evacuator compact K182224 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Lina Medical Aps. Cleared Feb 2019. https://www.510kdatabase.net/k182259/ 2019-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k182259-gentrix-surgical-matrix-gentrix-fda-510k.jpg K182259 - Gentrix Surgical Matrix, Gentrix Surgical Matrix Hiatal K182259 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Acell, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k182417/ 2019-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k182417-rosa-one-brain-application-fda-510k.jpg K182417 - ROSA ONE Brain Application K182417 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtech S.A. Cleared Feb 2019. https://www.510kdatabase.net/k183118/ 2019-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k183118-dpl-spotlite-fda-510k.jpg K183118 - dpl SpotLite K183118 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Led Technologies, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k183134/ 2019-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k183134-arctv-transvaginal-sling-system-fda-510k.jpg K183134 - ArcTV Transvaginal Sling System K183134 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Urocure, LLC. Cleared Feb 2019. https://www.510kdatabase.net/k183235/ 2019-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k183235-sonosite-sii-ultrasound-system-fda-510k.jpg K183235 - SonoSite SII Ultrasound System K183235 is a FDA 510(k) cleared radiology medical device. Manufacturer: FUJIFILM Sonosite, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k183331/ 2019-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k183331-parcus-gfs-btb-fda-510k.jpg K183331 - Parcus GFS BTB K183331 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Parcus Medical, LLC. Cleared Feb 2019. https://www.510kdatabase.net/k190035/ 2019-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k190035-biomet-headless-compression-and-twist-fda-510k.jpg K190035 - Biomet Headless Compression and Twist-Off Screws K190035 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k181981/ 2019-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k181981-co2-sampling-line-fda-510k.jpg K181981 - CO2 Sampling Line K181981 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Tylenol Medical Instruments Co., Ltd.. Cleared Feb 2019. https://www.510kdatabase.net/k182102/ 2019-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k182102-rhino-laryngo-videoscope-olympus-enf-fda-510k.jpg K182102 - RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-VH2, RHINO-LARYNGO VIDEOSCOPE OLYMPUS ENF-V4 K182102 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Feb 2019. https://www.510kdatabase.net/k182796/ 2019-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k182796-wavelinq-4f-endoavf-system-fda-510k.jpg K182796 - WavelinQ 4F EndoAVF System K182796 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k182885/ 2019-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k182885-atlantis-anterior-cervical-plate-fda-510k.jpg K182885 - Atlantis™ Anterior Cervical Plate, Divergence™ Anterior Cervical Fusion System, Premier™ Anterior Cervical Plate, Venture™ Anterior Cervical Plate, Zephir™ Anterior Cervical Plate System and Zevo™ Anterior Cervical Plate System K182885 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k183119/ 2019-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k183119-si-lok-sacroiliac-joint-fixation-fda-510k.jpg K183119 - SI-LOK® Sacroiliac Joint Fixation System, Navigation Instruments, ExcelsiusGPS® Instruments K183119 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k183435/ 2019-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k183435-echelon-endoscopic-linear-cutter-fda-510k.jpg K183435 - Echelon Endoscopic Linear Cutter Reloads, White, Blue, Gold, Green and Black K183435 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon Endo-Surgery, LLC. Cleared Feb 2019. https://www.510kdatabase.net/k183659/ 2019-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k183659-omnia-medical-rotary-plif-system-fda-510k.jpg K183659 - Omnia Medical Rotary PLIF System K183659 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Omnia Medical, LLC. Cleared Feb 2019. https://www.510kdatabase.net/k190045/ 2019-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k190045-dailies-colors-dailies-colors-toric-fda-510k.jpg K190045 - DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives K190045 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Alcon Laboratories, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k181142/ 2019-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k181142-absoanchor-microimplant-fda-510k.jpg K181142 - Absoanchor Microimplant K181142 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentos, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k182170/ 2019-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k182170-precice-bone-transport-system-fda-510k.jpg K182170 - PRECICE® BONE TRANSPORT™ System K182170 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nuvasive Specialized Orthopedics, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k183081/ 2019-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k183081-spectra-optia-apheresis-system-fda-510k.jpg K183081 - Spectra Optia Apheresis System K183081 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Terumobct, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k183132/ 2019-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k183132-halyard-pink-underguard-nitrile-powder-fda-510k.jpg K183132 - Halyard Pink Underguard Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs K183132 is a FDA 510(k) cleared general hospital medical device. Manufacturer: O&M Halyard, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k183163/ 2019-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k183163-intraoperative-single-use-sterile-fda-510k.jpg K183163 - Intraoperative, Single-Use, Sterile, Silicone Breast Sizer Motiva Implant Matrix K183163 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Motiva USA, LLC. Cleared Feb 2019. https://www.510kdatabase.net/k183388/ 2019-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k183388-jade-mobile-x-ray-fda-510k.jpg K183388 - JADE Mobile X-Ray K183388 is a FDA 510(k) cleared radiology medical device. Manufacturer: DRGEM Corporation. Cleared Feb 2019. https://www.510kdatabase.net/k183498/ 2019-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k183498-jusha-c270g-jusha-c270-c270g-c270-lcd-fda-510k.jpg K183498 - JUSHA-C270G/ JUSHA-C270/ C270G/ C270 LCD Monitor K183498 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nanjing Jusha Display Technology Co., Ltd.. Cleared Feb 2019. https://www.510kdatabase.net/k181916/ 2019-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k181916-d-nav-system-fda-510k.jpg K181916 - d-Nav System K181916 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hygieia, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k183447/ 2019-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k183447-eit-cellular-titanium-lumbar-cage-tplif-fda-510k.jpg K183447 - EIT Cellular Titanium Lumbar Cage - T/PLIF K183447 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Eit Emerging Implant Technologies GmbH. Cleared Feb 2019. https://www.510kdatabase.net/k183499/ 2019-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k183499-jusha-m350gjusha-m350m350gm350-lcd-fda-510k.jpg K183499 - JUSHA-M350G/JUSHA-M350/M350G/M350 LCD Monitor K183499 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nanjing Jusha Display Technology Co., Ltd.. Cleared Feb 2019. https://www.510kdatabase.net/k183571/ 2019-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k183571-capture-cmv-fda-510k.jpg K183571 - Capture-CMV K183571 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Immucor, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k190067/ 2019-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k190067-velofix-interbody-fusion-system-fda-510k.jpg K190067 - Velofix Interbody Fusion System K190067 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: U&I Corporation. Cleared Feb 2019. https://www.510kdatabase.net/k180626/ 2019-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k180626-pedimax-ii-pedicular-screw-spinal-system-fda-510k.jpg K180626 - Pedimax II - Pedicular Screw Spinal System K180626 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Gm Dos Reis Industria E Comerico Ltda.. Cleared Feb 2019. https://www.510kdatabase.net/k181070/ 2019-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k181070-ihealth-wireless-smart-gluco-fda-510k.jpg K181070 - iHealth Wireless Smart Gluco-Monitoring System (iHealth Gluco+) K181070 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Andon Health Co, Ltd.. Cleared Feb 2019. https://www.510kdatabase.net/k181657/ 2019-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k181657-easylctm-linear-cutter-staplers-and-fda-510k.jpg K181657 - easyLCTM Linear Cutter Staplers and Loading Units fot Single Use K181657 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ezisurg Medical Co., Ltd.. Cleared Feb 2019. https://www.510kdatabase.net/k181751/ 2019-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k181751-hemocue-hb-801-system-fda-510k.jpg K181751 - HemoCue Hb 801 System K181751 is a FDA 510(k) cleared hematology medical device. Manufacturer: Hemocue AB. Cleared Feb 2019. https://www.510kdatabase.net/k182094/ 2019-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k182094-family-of-venus-rf-systems-heal-fda-510k.jpg K182094 - Family of Venus RF Systems - Heal K182094 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Venus Concept USA, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k182191/ 2019-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k182191-invia-abdominal-dressing-kit-fda-510k.jpg K182191 - Invia Abdominal Dressing Kit K182191 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medela AG. Cleared Feb 2019. https://www.510kdatabase.net/k182319/ 2019-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k182319-glo-tip-spray-catheter-fda-510k.jpg K182319 - Glo-Tip Spray Catheter K182319 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Wilson-Cook Medical, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k182744/ 2019-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k182744-hemotrol-wb-low-hemotrol-wb-normal-fda-510k.jpg K182744 - HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High K182744 is a FDA 510(k) cleared hematology medical device. Manufacturer: Eurotrol B.V.. Cleared Feb 2019. https://www.510kdatabase.net/k183139/ 2019-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k183139-endoscope-sterilization-tray-fda-510k.jpg K183139 - Endoscope Sterilization Tray K183139 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k183272/ 2019-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k183272-ai-rad-companion-engine-fda-510k.jpg K183272 - AI Rad Companion (Engine) K183272 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 2019. https://www.510kdatabase.net/k183275/ 2019-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k183275-dr-800-with-tomosynthesis-fda-510k.jpg K183275 - DR 800 with Tomosynthesis K183275 is a FDA 510(k) cleared radiology medical device. Manufacturer: Agfa N.V.. Cleared Feb 2019. https://www.510kdatabase.net/k183291/ 2019-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k183291-supria-true64-whole-body-x-ray-ct-system-fda-510k.jpg K183291 - Supria True64 Whole-Body X-Ray CT System K183291 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hitachi Healthcare Americas. Cleared Feb 2019. https://www.510kdatabase.net/k183452/ 2019-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k183452-vbeam-prima-laser-system-fda-510k.jpg K183452 - Vbeam Prima Laser System K183452 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Candela Corp.. Cleared Feb 2019. https://www.510kdatabase.net/k190053/ 2019-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k190053-seculok-acp-system-fda-510k.jpg K190053 - SECULOK™ ACP System K190053 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: U&I Corporation. Cleared Feb 2019. https://www.510kdatabase.net/k181129/ 2019-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k181129-strong-dental-handpieces-fda-510k.jpg K181129 - STRONG Dental Handpieces K181129 is a FDA 510(k) cleared dental medical device. Manufacturer: Saeshin Precision Co., Ltd.. Cleared Jan 2019. https://www.510kdatabase.net/k182198/ 2019-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k182198-panoura-x-era-pfnfmf-fda-510k.jpg K182198 - Panoura X-ERA PF/NF/MF K182198 is a FDA 510(k) cleared radiology medical device. Manufacturer: The Yoshida Dental Mfg. Co., Ltd.. Cleared Jan 2019. https://www.510kdatabase.net/k182827/ 2019-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k182827-system-1-endo-liquid-chemical-fda-510k.jpg K182827 - SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900 K182827 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Jan 2019. https://www.510kdatabase.net/k183020/ 2019-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k183020-endosee-system-fda-510k.jpg K183020 - Endosee System K183020 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: CooperSurgical, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k182327/ 2019-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k182327-patient-cables-and-leadwires-fda-510k.jpg K182327 - Patient Cables and Leadwires , Disposable ECG Leadwires K182327 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Orantech, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k182986/ 2019-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k182986-boston-keratoprosthesis-type-i-lucia-fda-510k.jpg K182986 - Boston Keratoprosthesis, Type I Lucia K182986 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Massachusetts Eye and Ear Infirmary D/B/A Boston. Cleared Jan 2019. https://www.510kdatabase.net/k183029/ 2019-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k183029-moto-partial-knee-system-fda-510k.jpg K183029 - MOTO Partial Knee System K183029 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Jan 2019. https://www.510kdatabase.net/k183136/ 2019-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k183136-zimmer-segmental-system-proximal-fda-510k.jpg K183136 - Zimmer Segmental System Proximal Femoral Component K183136 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k183696/ 2019-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k183696-aequalis-perform-reversed-glenoid-fda-510k.jpg K183696 - Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid K183696 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tornier, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k181048/ 2019-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k181048-neo-cage-system-tm-fda-510k.jpg K181048 - Neo Cage System TM K181048 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Neo Medical SA. Cleared Jan 2019. https://www.510kdatabase.net/k181580/ 2019-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k181580-cortex-cadcam-abutments-fda-510k.jpg K181580 - Cortex CAD/CAM Abutments K181580 is a FDA 510(k) cleared dental medical device. Manufacturer: Cortex Dental Implants Industries , Ltd.. Cleared Jan 2019. https://www.510kdatabase.net/k181893/ 2019-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k181893-t-plus-fda-510k.jpg K181893 - T-PLUS K181893 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wintecare SA. Cleared Jan 2019. https://www.510kdatabase.net/k182000/ 2019-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k182000-aqrate-robotic-assistance-system-fda-510k.jpg K182000 - AQrate Robotic Assistance System K182000 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k182521/ 2019-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k182521-fastpack-ip-sex-hormone-binding-fda-510k.jpg K182521 - FastPack IP Sex Hormone Binding Globulin Immunoassay K182521 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Qualigen, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k182648/ 2019-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k182648-x5-series-digital-color-doppler-fda-510k.jpg K182648 - X5 Series Digital Color Doppler Ultrasound System K182648 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sonoscape Medical Corp.. Cleared Jan 2019. https://www.510kdatabase.net/k183022/ 2019-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k183022-solitaire-4-revascularization-device-fda-510k.jpg K183022 - Solitaire 4 Revascularization Device K183022 is a FDA 510(k) cleared neurology medical device. Manufacturer: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. Cleared Jan 2019. https://www.510kdatabase.net/k183070/ 2019-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k183070-asahi-neurovascular-guide-wire-asahi-fda-510k.jpg K183070 - ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010 K183070 is a FDA 510(k) cleared neurology medical device. Manufacturer: Asahi Intecc Co., Ltd.. Cleared Jan 2019. https://www.510kdatabase.net/k173743/ 2019-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k173743-greenmedi-safety-filter-syringe-fda-510k.jpg K173743 - Greenmedi Safety Filter Syringe K173743 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sang-A Frontec Co., Ltd.. Cleared Jan 2019. https://www.510kdatabase.net/k180822/ 2019-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k180822-varilift-lx-interbody-fusion-system-fda-510k.jpg K180822 - VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System K180822 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wenzel Spine, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k181307/ 2019-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k181307-zimmer-nexel-total-elbow-connradmorrey-fda-510k.jpg K181307 - Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow K181307 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k181775/ 2019-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k181775-quantum-blood-and-iv-fluid-infusion-fda-510k.jpg K181775 - Quantum Blood and IV Fluid Infusion Warmer K181775 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Life Warmer, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k182093/ 2019-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k182093-zoll-ecg-analysis-software-fda-510k.jpg K182093 - ZOLL ECG Analysis Software K182093 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Zoll Manufacturing Corporation. Cleared Jan 2019. https://www.510kdatabase.net/k182228/ 2019-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k182228-mis-lockit-abutments-system-ot-fda-510k.jpg K182228 - MIS LOCKiT Abutments System, OT-Equators and Ball Attachments K182228 is a FDA 510(k) cleared dental medical device. Manufacturer: Mis Implants Technologies , Ltd.. Cleared Jan 2019. https://www.510kdatabase.net/k182477/ 2019-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k182477-cervical-spacer-fda-510k.jpg K182477 - Cervical Spacer K182477 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Additive Implants, LLC. Cleared Jan 2019. https://www.510kdatabase.net/k183001/ 2019-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k183001-wego-pgla-rapid-fda-510k.jpg K183001 - WEGO-PGLA RAPID K183001 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Foosin Medical Supplies Inc., Ltd.. Cleared Jan 2019. https://www.510kdatabase.net/k183004/ 2019-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k183004-wego-pga-rapid-fda-510k.jpg K183004 - WEGO-PGA RAPID K183004 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Foosin Medical Supplies Inc., Ltd.. Cleared Jan 2019. https://www.510kdatabase.net/k183025/ 2019-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k183025-mobio-total-knee-system-posterior-fda-510k.jpg K183025 - MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component K183025 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: B-One Ortho, Corp.. Cleared Jan 2019. https://www.510kdatabase.net/k183362/ 2019-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k183362-venue-go-fda-510k.jpg K183362 - Venue GO K183362 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared Jan 2019. https://www.510kdatabase.net/k183456/ 2019-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k183456-aloka-arietta-850-fda-510k.jpg K183456 - Aloka Arietta 850 K183456 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hitachi Healthcare Americas. Cleared Jan 2019. https://www.510kdatabase.net/k180230/ 2019-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k180230-nest-interbody-system-fda-510k.jpg K180230 - NEST Interbody System K180230 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paonan Biotech Co., Ltd.. Cleared Jan 2019. https://www.510kdatabase.net/k180780/ 2019-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k180780-microinr-system-fda-510k.jpg K180780 - microINR System K180780 is a FDA 510(k) cleared hematology medical device. Manufacturer: Iline Microsystems, S.L.. Cleared Jan 2019. https://www.510kdatabase.net/k182078/ 2019-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k182078-minicollect-k2e-k2edta-tubes-fda-510k.jpg K182078 - MiniCollect K2E K2EDTA Tubes K182078 is a FDA 510(k) cleared hematology medical device. Manufacturer: Greiner Bio-One Na, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k182389/ 2019-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k182389-sysmex-xn-l-automated-hematology-fda-510k.jpg K182389 - Sysmex XN-L Automated Hematology Analyzer K182389 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sysmex America, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k182480/ 2019-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k182480-earlens-contact-hearing-aid-fda-510k.jpg K182480 - Earlens Contact Hearing Aid K182480 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Earlens Corporation. Cleared Jan 2019. https://www.510kdatabase.net/k182548/ 2019-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k182548-accucuff-cuff-pressure-indicator-fda-510k.jpg K182548 - Accucuff Cuff Pressure Indicator K182548 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Tianjin Medis Medical Device Co., Ltd.. Cleared Jan 2019. https://www.510kdatabase.net/k182642/ 2019-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k182642-genesiszr-4y-zirconia-fda-510k.jpg K182642 - GenesisZr™ 4Y Zirconia K182642 is a FDA 510(k) cleared dental medical device. Manufacturer: United Dental Resources Corporation. Cleared Jan 2019. https://www.510kdatabase.net/k182895/ 2019-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k182895-wilson-cook-achalasia-balloon-fda-510k.jpg K182895 - Wilson-Cook Achalasia Balloon K182895 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Wilson-Cook Medical, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k182919/ 2019-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k182919-si-restore-sacroiliac-joint-fixation-fda-510k.jpg K182919 - SI-Restore® Sacroiliac Joint Fixation System K182919 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biofusion Medical. Cleared Jan 2019. https://www.510kdatabase.net/k182968/ 2019-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k182968-hoffmann-lrf-system-fda-510k.jpg K182968 - Hoffmann LRF System K182968 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker GmbH. Cleared Jan 2019. https://www.510kdatabase.net/k183042/ 2019-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k183042-smr-lateralized-connectors-with-screws-fda-510k.jpg K183042 - SMR Lateralized Connectors with screws K183042 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Lima Corporate S.P.A.. Cleared Jan 2019. https://www.510kdatabase.net/k183228/ 2019-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k183228-hammertoe-compression-system-fda-510k.jpg K183228 - HammerToe Compression System K183228 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paragon 28, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k183321/ 2019-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k183321-treace-medical-concepts-tmc-plating-fda-510k.jpg K183321 - Treace Medical Concepts (TMC) Plating System K183321 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Treace Medical Concepts, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k183468/ 2019-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k183468-revive-reusable-bladder-support-fda-510k.jpg K183468 - Revive Reusable Bladder Support K183468 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Rinovum Subsidiary 2, LLC. Cleared Jan 2019. https://www.510kdatabase.net/k183615/ 2019-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k183615-ellipsys-vascular-access-system-fda-510k.jpg K183615 - Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle K183615 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Avenu Medical, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k183631/ 2019-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k183631-medi-pneumatic-compression-system-pcs-fda-510k.jpg K183631 - medi pneumatic compression system (pcs) – brio (Model 651) K183631 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medi USA, LP. Cleared Jan 2019. https://www.510kdatabase.net/k180183/ 2019-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k180183-ritter-dental-implant-system-fda-510k.jpg K180183 - Ritter Dental Implant System K180183 is a FDA 510(k) cleared dental medical device. Manufacturer: Ritter Implants GmbH CO KG. Cleared Jan 2019. https://www.510kdatabase.net/k181056/ 2019-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k181056-reprocessed-cs-diagnostic-fda-510k.jpg K181056 - Reprocessed CS Diagnostic Electrophysiology Catheter K181056 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Stryker Sustainability Solutions. Cleared Jan 2019. https://www.510kdatabase.net/k181135/ 2019-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k181135-immunalysis-sefria-pcp-oral-fluid-fda-510k.jpg K181135 - Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay K181135 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Immunalysis Corporation. Cleared Jan 2019. https://www.510kdatabase.net/k182297/ 2019-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k182297-surveyor-s2-fda-510k.jpg K182297 - Surveyor S2 K182297 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Mortara Instrument, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k182312/ 2019-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k182312-zyppah-anti-snoring-device-fda-510k.jpg K182312 - Zyppah Anti-Snoring Device K182312 is a FDA 510(k) cleared dental medical device. Manufacturer: Always More Marketing. Cleared Jan 2019. https://www.510kdatabase.net/k182363/ 2019-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k182363-btl-703-fda-510k.jpg K182363 - BTL-703 K182363 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: BTL Industries, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k182514/ 2019-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k182514-surgical-face-mask-fda-510k.jpg K182514 - Surgical Face Mask K182514 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Xiantao Zhibo Non-Woven Products Co., Ltd.. Cleared Jan 2019. https://www.510kdatabase.net/k182594/ 2019-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k182594-e-cube-i7-fda-510k.jpg K182594 - E-CUBE i7 K182594 is a FDA 510(k) cleared radiology medical device. Manufacturer: Alpinion Medical Systems Co., Ltd.. Cleared Jan 2019. https://www.510kdatabase.net/k182964/ 2019-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k182964-rosa-knee-system-fda-510k.jpg K182964 - ROSA Knee System K182964 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthosoft Inc. (d/b/a) Zimmer CAS. Cleared Jan 2019. https://www.510kdatabase.net/k183244/ 2019-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k183244-magnetom-lumina-fda-510k.jpg K183244 - MAGNETOM Lumina K183244 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k183346/ 2019-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k183346-flow-90-wand-fda-510k.jpg K183346 - FLOW 90 Wand K183346 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: ArthroCare Corporation. Cleared Jan 2019. https://www.510kdatabase.net/k183541/ 2019-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k183541-prorad-2fc-and-prorad-3nc-stationary-fda-510k.jpg K183541 - ProRad 2FC and ProRad 3NC Stationary Radiographic Systems K183541 is a FDA 510(k) cleared radiology medical device. Manufacturer: Prognosys Medical Systems Private Limited. Cleared Jan 2019. https://www.510kdatabase.net/k181387/ 2019-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k181387-pre-formed-penile-silicone-block-fda-510k.jpg K181387 - Pre-Formed Penile Silicone Block K181387 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: International Medical Devices, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k181956/ 2019-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k181956-masimo-mightysat-rx-fingertip-pulse-fda-510k.jpg K181956 - Masimo MightySat Rx Fingertip Pulse Oximeter K181956 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Masimo Corporation. Cleared Jan 2019. https://www.510kdatabase.net/k182907/ 2019-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k182907-spy-elite-intraoperative-perfusion-fda-510k.jpg K182907 - SPY Elite Intraoperative Perfusion Assessment System K182907 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Novadaq Technologies Ulc. (Now A Part of Stryker). Cleared Jan 2019. https://www.510kdatabase.net/k183151/ 2019-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k183151-optilite-iga-csf-kit-fda-510k.jpg K183151 - Optilite IgA CSF Kit K183151 is a FDA 510(k) cleared immunology medical device. Manufacturer: The Binding Site Group , Ltd.. Cleared Jan 2019. https://www.510kdatabase.net/den180047/ 2019-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/den180047-aptima-mycoplasma-genitalium-assay-fda-510k.jpg DEN180047 - Aptima Mycoplasma genitalium Assay DEN180047 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Hologic, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k180767/ 2019-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k180767-femon-banana-thermometer-fda-510k.jpg K180767 - FEMON Banana Thermometer K180767 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Life Science Technology, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k181887/ 2019-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k181887-amd-anti-fog-solution-fda-510k.jpg K181887 - AMD Anti-Fog Solution K181887 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Advanced Medical Design Co., Ltd.. Cleared Jan 2019. https://www.510kdatabase.net/k182193/ 2019-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k182193-s-line-fda-510k.jpg K182193 - S-Line K182193 is a FDA 510(k) cleared dental medical device. Manufacturer: Biocetec Co., Ltd.. Cleared Jan 2019. https://www.510kdatabase.net/k182574/ 2019-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k182574-freedom-ultra-congruent-cr-tibial-liner-fda-510k.jpg K182574 - Freedom Ultra-Congruent CR Tibial Liner K182574 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Maxx Orthopedics, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k182837/ 2019-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k182837-must-mini-extension-fda-510k.jpg K182837 - M.U.S.T. Mini Extension K182837 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Jan 2019. https://www.510kdatabase.net/k182894/ 2019-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k182894-hm70a-diagnostic-ultrasound-system-fda-510k.jpg K182894 - HM70A Diagnostic Ultrasound System K182894 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Medison Co., Ltd.. Cleared Jan 2019. https://www.510kdatabase.net/k182955/ 2019-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k182955-ezstart-interference-screw-fda-510k.jpg K182955 - EZStart Interference Screw K182955 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Conmed Corporation. Cleared Jan 2019. https://www.510kdatabase.net/k182970/ 2019-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k182970-europa-pedicle-screw-system-fda-510k.jpg K182970 - EUROPA™ Pedicle Screw System K182970 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: MiRus, LLC. Cleared Jan 2019. https://www.510kdatabase.net/k183553/ 2019-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k183553-compress-and-mini-compress-anti-fda-510k.jpg K183553 - Compress and Mini Compress Anti-Rotation Spindles K183553 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k183636/ 2019-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k183636-spyscope-ds-access-and-delivery-fda-510k.jpg K183636 - SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller K183636 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Jan 2019. https://www.510kdatabase.net/k183671/ 2019-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k183671-lg-pral-derma-led-mask-fda-510k.jpg K183671 - LG PRA.L DERMA LED MASK K183671 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lg Electronics.Inc. Cleared Jan 2019. https://www.510kdatabase.net/k183685/ 2019-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k183685-o-scan-fda-510k.jpg K183685 - O-Scan K183685 is a FDA 510(k) cleared radiology medical device. Manufacturer: Esaote, S.P.A.. Cleared Jan 2019. https://www.510kdatabase.net/k182507/ 2019-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k182507-tigon-medical-tissue-anchors-fda-510k.jpg K182507 - Tigon Medical Tissue Anchors K182507 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tigon Medical. Cleared Jan 2019. https://www.510kdatabase.net/k183357/ 2019-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k183357-xablecath-crossing-catheter-fda-510k.jpg K183357 - XableCath Crossing Catheter K183357 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Xablecath, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k183581/ 2019-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k183581-codman-disposable-perforators-fda-510k.jpg K183581 - Codman Disposable Perforators K183581 is a FDA 510(k) cleared neurology medical device. Manufacturer: Integra Lifesciences Corp.. Cleared Jan 2019. https://www.510kdatabase.net/k182527/ 2019-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k182527-elan-4-tools-fda-510k.jpg K182527 - ELAN 4 Tools K182527 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k180236/ 2019-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k180236-vr-medical-feeding-tube-and-enteral-fda-510k.jpg K180236 - VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES) K180236 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Vr Medical Technology Co., Ltd.. Cleared Jan 2019. https://www.510kdatabase.net/k181076/ 2019-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k181076-responsive-arthroscopy-wedge-push-in-fda-510k.jpg K181076 - Responsive Arthroscopy Wedge Push-In Suture Anchors K181076 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Responsive Arthroscopy, LLC. Cleared Jan 2019. https://www.510kdatabase.net/k181084/ 2019-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k181084-pentax-video-colonoscopes-ec-family-fda-510k.jpg K181084 - PENTAX Video Colonoscopes (EC Family) K181084 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Pentax of America, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k181097/ 2019-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k181097-cook-cystostomy-catheter-set-fda-510k.jpg K181097 - Cook Cystostomy Catheter Set K181097 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Jan 2019. https://www.510kdatabase.net/k181099/ 2019-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k181099-bright-guard-fda-510k.jpg K181099 - Bright Guard K181099 is a FDA 510(k) cleared dental medical device. Manufacturer: Koncept Innovators, LLC. Cleared Jan 2019. https://www.510kdatabase.net/k181126/ 2019-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k181126-reprocessed-visions-pv-035-digital-fda-510k.jpg K181126 - Reprocessed Visions PV .035 Digital IVUS Catheter K181126 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Innovative Health, LLC. Cleared Jan 2019. https://www.510kdatabase.net/k181895/ 2019-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k181895-kurin-piv-blood-collection-set-with-fda-510k.jpg K181895 - Kurin PIV Blood Collection Set with High Pressure K181895 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Kurin, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k182211/ 2019-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k182211-aurora-surgiscope-system-fda-510k.jpg K182211 - Aurora Surgiscope System K182211 is a FDA 510(k) cleared neurology medical device. Manufacturer: Rebound Therapeutics Corporation. Cleared Jan 2019. https://www.510kdatabase.net/k182284/ 2019-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k182284-tyber-medical-pt-interbody-spacer-fda-510k.jpg K182284 - Tyber Medical PT Interbody Spacer K182284 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tyber Medical, LLC. Cleared Jan 2019. https://www.510kdatabase.net/k182323/ 2019-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k182323-pico-7y-single-use-negative-pressure-fda-510k.jpg K182323 - PICO 7Y Single Use Negative Pressure Wound Therapy System K182323 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew Medical Limited. Cleared Jan 2019. https://www.510kdatabase.net/k182518/ 2019-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k182518-ahmed-clearpath-glaucoma-drainage-device-fda-510k.jpg K182518 - AHMED ClearPath Glaucoma Drainage Device K182518 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: New World Medical, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k182620/ 2019-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k182620-mri-compatibility-for-existing-neodent-fda-510k.jpg K182620 - MRI Compatibility for Existing Neodent Implant System K182620 is a FDA 510(k) cleared dental medical device. Manufacturer: Jjgc Industria E Comercio DE Materiais Dentarios S.A.. Cleared Jan 2019. https://www.510kdatabase.net/k182782/ 2019-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k182782-dailies-total1-dailies-total1-asphere-fda-510k.jpg K182782 - DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1 Multifocal, DAILIES TOTAL1 Multifocal Toric K182782 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Alcon Laboratories, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k182784/ 2019-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k182784-mutyh-associated-polyposis-map-fda-510k.jpg K182784 - MUTYH-Associated Polyposis (MAP) K182784 is a FDA 510(k) cleared medical genetics medical device. Manufacturer: 23AndMe, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k182951/ 2019-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k182951-pristina-serena-3d-fda-510k.jpg K182951 - Pristina Serena 3D K182951 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Jan 2019. https://www.510kdatabase.net/k182956/ 2019-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k182956-puffin-lite-infant-resuscitation-system-fda-510k.jpg K182956 - Puffin Lite Infant Resuscitation System K182956 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: International Biomedical. Cleared Jan 2019. https://www.510kdatabase.net/k183224/ 2019-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k183224-sureform-45-sureform-45-reloads-fda-510k.jpg K183224 - SureForm 45, SureForm 45 Reloads K183224 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical. Cleared Jan 2019. https://www.510kdatabase.net/k183231/ 2019-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k183231-signa-premier-fda-510k.jpg K183231 - SIGNA Premier K183231 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems, LLC. Cleared Jan 2019. https://www.510kdatabase.net/k183254/ 2019-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k183254-magnetom-vida-fda-510k.jpg K183254 - Magnetom Vida K183254 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k183264/ 2019-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k183264-flex-thor-scope-fda-510k.jpg K183264 - Flex-THOR scope K183264 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k183298/ 2019-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k183298-hardydisk-ast-omadacycline-30g-omc30-fda-510k.jpg K183298 - HardyDisk AST Omadacycline 30µg (OMC30) K183298 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Hardy Diagnostics. Cleared Jan 2019. https://www.510kdatabase.net/k180779/ 2019-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k180779-savina-300-fda-510k.jpg K180779 - Savina 300 K180779 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Dragerwerk AG & CO Kgaa. Cleared Jan 2019. https://www.510kdatabase.net/k181190/ 2019-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k181190-pinehurst-anterior-cervical-plate-system-fda-510k.jpg K181190 - Pinehurst Anterior Cervical Plate System K181190 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Signature Orthopaedics Pty, Ltd.. Cleared Jan 2019. https://www.510kdatabase.net/k181302/ 2019-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k181302-bodycad-unicompartmental-knee-system-fda-510k.jpg K181302 - Bodycad Unicompartmental Knee System K181302 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Bodycad Laboratories, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k181338/ 2019-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k181338-imboki-knee-instrument-system-fda-510k.jpg K181338 - Imboki Knee Instrument System K181338 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Signature Orthopaedics Pty, Ltd.. Cleared Jan 2019. https://www.510kdatabase.net/k182010/ 2019-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k182010-progenamatrix-fda-510k.jpg K182010 - ProgenaMatrix K182010 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cell Constructs I, LLC. Cleared Jan 2019. https://www.510kdatabase.net/k182111/ 2019-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k182111-dl-self-adhesive-electrode-fda-510k.jpg K182111 - DL Self-adhesive Electrode K182111 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shaoxing DL Healthcare Co., Ltd.. Cleared Jan 2019. https://www.510kdatabase.net/k182227/ 2019-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k182227-esprit-nova-fda-510k.jpg K182227 - Esprit Nova K182227 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neurozone Msh Incorporated. Cleared Jan 2019. https://www.510kdatabase.net/k182456/ 2019-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k182456-study-watch-fda-510k.jpg K182456 - Study Watch K182456 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Verily Life Sciences, LLC. Cleared Jan 2019. https://www.510kdatabase.net/k183060/ 2019-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k183060-cervalign-anterior-cervical-plate-system-fda-510k.jpg K183060 - CervAlign™ Anterior Cervical Plate System K183060 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.). Cleared Jan 2019. https://www.510kdatabase.net/k183538/ 2019-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k183538-viva-combo-rf-system-fda-510k.jpg K183538 - VIVA combo RF System K183538 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Starmed Co., Ltd.. Cleared Jan 2019. https://www.510kdatabase.net/k173847/ 2019-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k173847-disposable-ultra-reinforced-surgical-fda-510k.jpg K173847 - Disposable Ultra Reinforced Surgical Gown K173847 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Xiantao Rayxin Medical Products Co., Ltd.. Cleared Jan 2019. https://www.510kdatabase.net/k180410/ 2019-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k180410-dosis-sam-fda-510k.jpg K180410 - Dosis SAM K180410 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Dosis, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k181071/ 2019-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k181071-sira-rfa-electrosurgical-device-fda-510k.jpg K181071 - SIRA RFA Electrosurgical Device K181071 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Innoblative Designs, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k181106/ 2019-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k181106-powder-free-nitrile-patient-fda-510k.jpg K181106 - Powder Free Nitrile Patient Examination Gloves, Blue Color K181106 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Dongxin Medical Technology Co., Ltd.. Cleared Jan 2019. https://www.510kdatabase.net/k181451/ 2019-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k181451-uretero-reno-videoscope-olympus-urf-fda-510k.jpg K181451 - URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R K181451 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Jan 2019. https://www.510kdatabase.net/k181540/ 2019-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k181540-estremo-citieffe-nailing-system-fda-510k.jpg K181540 - Estremo Citieffe Nailing System K181540 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Citieffe S.R.L.. Cleared Jan 2019. https://www.510kdatabase.net/k182489/ 2019-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k182489-4cis-pinehurst-anterior-cervical-plate-fda-510k.jpg K182489 - 4CIS® Pinehurst Anterior Cervical Plate system K182489 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Solco Biomedical Co., Ltd.. Cleared Jan 2019. https://www.510kdatabase.net/k182538/ 2019-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k182538-merit-radialflo-arterial-catheter-fda-510k.jpg K182538 - Merit RadialFlo Arterial Catheter K182538 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Singapore Pte. , Ltd.. Cleared Jan 2019. https://www.510kdatabase.net/k182651/ 2019-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k182651-hba1c-advanced-fda-510k.jpg K182651 - HbA1c Advanced K182651 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter Ireland, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k183165/ 2019-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k183165-pristine-scope-fda-510k.jpg K183165 - Pristine Scope K183165 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Pristine Surgical. Cleared Jan 2019. https://www.510kdatabase.net/k183329/ 2019-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k183329-laser-hair-therapy-fda-510k.jpg K183329 - Laser Hair Therapy K183329 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Omm Imports, Inc. D/B/A Zero Gravity. Cleared Jan 2019. https://www.510kdatabase.net/k183474/ 2019-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k183474-carestream-drx-1-system-with-drx-core-fda-510k.jpg K183474 - Carestream DRX-1 System with DRX Core Detectors K183474 is a FDA 510(k) cleared radiology medical device. Manufacturer: Carestream Health, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k183510/ 2019-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k183510-t2-stratosphere-expandable-corpectomy-fda-510k.jpg K183510 - T2 STRATOSPHERE Expandable Corpectomy System K183510 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k181096/ 2019-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k181096-avenue-p-cage-system-fda-510k.jpg K181096 - Avenue P Cage System K181096 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer Biomet Spine, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k182478/ 2019-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k182478-whistler-modular-pedicle-screw-system-fda-510k.jpg K182478 - Whistler Modular Pedicle Screw System K182478 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Evolution Spine, LLC. Cleared Jan 2019. https://www.510kdatabase.net/k182497/ 2019-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k182497-osteocool-rf-ablation-system-fda-510k.jpg K182497 - OsteoCool RF Ablation System K182497 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k183497/ 2019-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k183497-jusha-m260g-lcd-monitor-jusha-m260-lcd-fda-510k.jpg K183497 - JUSHA-M260G LCD Monitor, JUSHA-M260 LCD Monitor, M260G LCD Monitor, M260 LCD Monitor K183497 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nanjing Jusha Display Technology Co., Ltd.. Cleared Jan 2019. https://www.510kdatabase.net/k180570/ 2019-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k180570-silverlon-island-wound-dressing-fda-510k.jpg K180570 - Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing) K180570 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Argentum Medical, LLC. Cleared Jan 2019. https://www.510kdatabase.net/k182307/ 2019-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k182307-small-bone-phantom-intramedullary-nail-fda-510k.jpg K182307 - Small Bone Phantom® Intramedullary Nail System K182307 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paragon 28, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k182898/ 2019-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k182898-tenotac-soft-tissue-fixation-system-fda-510k.jpg K182898 - TenoTac Soft Tissue Fixation System K182898 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paragon 28, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k183514/ 2019-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k183514-zeltiq-coolsculpting-system-fda-510k.jpg K183514 - ZELTIQ CoolSculpting System K183514 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Zeltiq Aesthetics, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k180228/ 2019-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k180228-ii-type-intervertebral-spacer-fda-510k.jpg K180228 - II-Type Intervertebral Spacer K180228 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paonan Biotech Co., Ltd.. Cleared Jan 2019. https://www.510kdatabase.net/k180229/ 2019-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k180229-rescan-700-callisto-eye-fda-510k.jpg K180229 - RESCAN 700, CALLISTO eye K180229 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Carl Zeiss Meditec, AG. Cleared Jan 2019. https://www.510kdatabase.net/k180902/ 2019-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k180902-medipines-gas-exchange-monitor-gem-fda-510k.jpg K180902 - MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly K180902 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Medipines Corporation. Cleared Jan 2019. https://www.510kdatabase.net/k181377/ 2019-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k181377-prostep-mica-screw-system-fda-510k.jpg K181377 - PROSTEP MICA Screw System K181377 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jan 2019. https://www.510kdatabase.net/k181649/ 2019-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k181649-aerochamber-plus-flow-vu-anti-static-fda-510k.jpg K181649 - AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC) K181649 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Trudell Medical International. Cleared Jan 2019. https://www.510kdatabase.net/k181805/ 2019-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k181805-uv-phototherapy-fda-510k.jpg K181805 - UV Phototherapy K181805 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Xuzhou Kernel Medical Equipment Co., Ltd.. Cleared Jan 2019. https://www.510kdatabase.net/k181917/ 2019-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k181917-mta23-materials-fda-510k.jpg K181917 - MTA2.3 MATERIALS K181917 is a FDA 510(k) cleared dental medical device. Manufacturer: NuSmile, Ltd.. Cleared Jan 2019. https://www.510kdatabase.net/k182202/ 2019-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k182202-sleepapp-fda-510k.jpg K182202 - SLEEPAPP K182202 is a FDA 510(k) cleared dental medical device. Manufacturer: Comfort Acrylics, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k182212/ 2019-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k182212-geo-staple-system-fda-510k.jpg K182212 - Geo Staple System K182212 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Gramercy Extremity Orthopedics, LLC. Cleared Jan 2019. https://www.510kdatabase.net/k182409/ 2019-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k182409-applied-tissue-technologies-pwd-fda-510k.jpg K182409 - Applied Tissue Technologies PWD™ Platform Wound Dressing K182409 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Applied Tissue Technologies, LLC. Cleared Jan 2019. https://www.510kdatabase.net/k182421/ 2019-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k182421-senhance-ultrasonic-system-fda-510k.jpg K182421 - Senhance Ultrasonic System K182421 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Transenterix, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k182453/ 2019-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k182453-icoone-h-also-referred-to-as-icoone-fda-510k.jpg K182453 - ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER) K182453 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: I-Tech Industries Srl. Cleared Jan 2019. https://www.510kdatabase.net/k182500/ 2019-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k182500-catalyst-csr-press-fit-humeral-fda-510k.jpg K182500 - Catalyst CSR Press-Fit Humeral Components K182500 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Catalyst Orthoscience, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k182517/ 2019-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k182517-multix-impact-fda-510k.jpg K182517 - MULTIX Impact K182517 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medi Cal Solutions, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k182545/ 2019-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k182545-tamper-evident-cap-with-male-luer-lock-fda-510k.jpg K182545 - Tamper Evident Cap with Male Luer Lock K182545 is a FDA 510(k) cleared general hospital medical device. Manufacturer: International Medical Industries, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k182928/ 2019-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k182928-cd-horizon-spinal-system-fda-510k.jpg K182928 - CD Horizon™ Spinal System K182928 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k182973/ 2019-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k182973-digitaldiagnost-c90-fda-510k.jpg K182973 - DigitalDiagnost C90 K182973 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Dmc GmbH. Cleared Jan 2019. https://www.510kdatabase.net/k183031/ 2019-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k183031-etest-meropenemvaborbactam-mev-00048-fda-510k.jpg K183031 - ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL) K183031 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Biomerieux S.A.. Cleared Jan 2019. https://www.510kdatabase.net/k183137/ 2019-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k183137-umr-580-umr-588-fda-510k.jpg K183137 - uMR 580, uMR 588 K183137 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Jan 2019. https://www.510kdatabase.net/k183140/ 2019-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k183140-mts-tetracycline-0016-256-ugml-fda-510k.jpg K183140 - MTS Tetracycline 0.016 - 256 ug/mL K183140 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Liofilchem S. R. L.. Cleared Jan 2019. https://www.510kdatabase.net/k183406/ 2019-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k183406-cerelink-icp-monitor-cerelink-icp-fda-510k.jpg K183406 - CereLink ICP Monitor, CereLink ICP Extension Cable K183406 is a FDA 510(k) cleared neurology medical device. Manufacturer: Integra Lifesciences Corp.. Cleared Jan 2019. https://www.510kdatabase.net/k183467/ 2019-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k183467-roadrunner-extra-support-wire-guide-fda-510k.jpg K183467 - Roadrunner Extra Support Wire Guide K183467 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Jan 2019. https://www.510kdatabase.net/k180355/ 2019-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k180355-advocate-non-contact-infrared-fda-510k.jpg K180355 - Advocate Non-Contact Infrared Thermometer K180355 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Broadmaster Biotech, Corp.. Cleared Jan 2019. https://www.510kdatabase.net/k180387/ 2019-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k180387-infrared-ear-thermometer-fda-510k.jpg K180387 - Infrared Ear Thermometer K180387 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hetaida Technology Co., Ltd.. Cleared Jan 2019. https://www.510kdatabase.net/k180837/ 2019-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k180837-contec-oxygen-concentrator-fda-510k.jpg K180837 - CONTEC Oxygen Concentrator K180837 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Contec Medical System Co., Ltd.. Cleared Jan 2019. https://www.510kdatabase.net/k181180/ 2019-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k181180-ossio-pin-product-family-fda-510k.jpg K181180 - OSSIO™ Pin Product Family K181180 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OSSIO , Ltd.. Cleared Jan 2019. https://www.510kdatabase.net/k181204/ 2019-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k181204-renasys-y-connector-fda-510k.jpg K181204 - RENASYS Y-Connector K181204 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew Medical Limited. Cleared Jan 2019. https://www.510kdatabase.net/k181444/ 2019-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k181444-clarus-fda-510k.jpg K181444 - CLARUS K181444 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Carl Zeiss Meditec, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k182120/ 2019-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k182120-maxpower-relief-fda-510k.jpg K182120 - Maxpower Relief K182120 is a FDA 510(k) cleared neurology medical device. Manufacturer: Omron Healthcare, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k182367/ 2019-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k182367-diasafeplusus-fda-510k.jpg K182367 - DIASAFEplusUS K182367 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC. Cleared Jan 2019. https://www.510kdatabase.net/k182635/ 2019-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k182635-signal-catheter-fda-510k.jpg K182635 - Signal Catheter K182635 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Safe Medical Design. Cleared Jan 2019. https://www.510kdatabase.net/k182636/ 2019-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k182636-dc-60dc-60sdc-60-expdc-55-diagnostic-fda-510k.jpg K182636 - DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System K182636 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Jan 2019. https://www.510kdatabase.net/k182727/ 2019-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k182727-trident-hd-specimen-radiography-system-fda-510k.jpg K182727 - Trident HD Specimen Radiography System K182727 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hologic, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k182873/ 2019-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k182873-stratafix-symmetric-pds-plus-knotless-fda-510k.jpg K182873 - STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control Devices K182873 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k183011/ 2019-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k183011-additive-orthopaedics-patient-specific-fda-510k.jpg K183011 - Additive Orthopaedics Patient Specific 3D Locking Lattice Plates K183011 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Additive Orthopaedics. Cleared Jan 2019. https://www.510kdatabase.net/k183071/ 2019-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k183071-vlift-s-vertebral-body-replacement-fda-510k.jpg K183071 - VLIFT-s Vertebral Body Replacement System K183071 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Spine. Cleared Jan 2019. https://www.510kdatabase.net/k183097/ 2019-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k183097-kangzhou-one-step-hcg-test-strip-fda-510k.jpg K183097 - Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream K183097 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Weihai Kangzhou Biotechnology Engineering Co., Ltd.. Cleared Jan 2019. https://www.510kdatabase.net/k183616/ 2019-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k183616-hanarostent-lowax-colonrectum-nnn-fda-510k.jpg K183616 - HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN) K183616 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: M.I. Tech Co., Ltd.. Cleared Jan 2019. https://www.510kdatabase.net/k181047/ 2019-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k181047-powder-free-white-blue-sterilized-fda-510k.jpg K181047 - Powder Free White, Blue Sterilized Nitrile Copolymer Surgical Gloves Tested for Use with Chemotherapy Drugs K181047 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Smart Glove Corporation Sdn. Bhd.. Cleared Jan 2019. https://www.510kdatabase.net/k181086/ 2019-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k181086-cortical-fixation-systems-fda-510k.jpg K181086 - Cortical Fixation Systems K181086 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Cousin Biotech Sas. Cleared Jan 2019. https://www.510kdatabase.net/k181118/ 2019-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k181118-reliance-lumbar-ibf-system-fda-510k.jpg K181118 - Reliance Lumbar IBF System K181118 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Reliance Medical Systems. Cleared Jan 2019. https://www.510kdatabase.net/k181282/ 2019-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k181282-g3a-40-bone-cement-fda-510k.jpg K181282 - G3A 40 Bone Cement K181282 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: G21, S.R.L.. Cleared Jan 2019. https://www.510kdatabase.net/k181637/ 2019-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k181637-dc-70dc-70tdc-70-prodc-70-expdc-75dc-fda-510k.jpg K181637 - DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System K181637 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Jan 2019. https://www.510kdatabase.net/k182846/ 2019-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k182846-pentax-medical-epk-3000-video-imaging-fda-510k.jpg K182846 - PENTAX Medical EPK-3000 Video Imaging System K182846 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Pentax of America, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k182869/ 2019-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k182869-fit-sa-fda-510k.jpg K182869 - Fit SA K182869 is a FDA 510(k) cleared dental medical device. Manufacturer: Shofu Dental Corporation. Cleared Jan 2019. https://www.510kdatabase.net/k183133/ 2019-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k183133-mrcp-v10-fda-510k.jpg K183133 - MRCP+ v1.0 K183133 is a FDA 510(k) cleared radiology medical device. Manufacturer: Perspectum Diagnostics, Ltd.. Cleared Jan 2019. https://www.510kdatabase.net/k183200/ 2019-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k183200-isee-roflufocon-d-roflufocon-e-daily-fda-510k.jpg K183200 - iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses K183200 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: C&E GP Specialist, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k183422/ 2019-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k183422-wireless-digital-flat-panel-detector-fda-510k.jpg K183422 - Wireless Digital Flat Panel Detector K183422 is a FDA 510(k) cleared radiology medical device. Manufacturer: Iray Technology Taicang , Ltd.. Cleared Jan 2019. https://www.510kdatabase.net/k183713/ 2019-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k183713-wireless-digital-flat-detector-fda-510k.jpg K183713 - Wireless Digital Flat Detector K183713 is a FDA 510(k) cleared radiology medical device. Manufacturer: Iray Technology Taicang , Ltd.. Cleared Jan 2019. https://www.510kdatabase.net/k180648/ 2019-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k180648-park-dental-research-aligners-fda-510k.jpg K180648 - Park Dental Research Aligners K180648 is a FDA 510(k) cleared dental medical device. Manufacturer: Park Dental Research Corporation. Cleared Jan 2019. https://www.510kdatabase.net/k182439/ 2019-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k182439-trushot-with-y-knot-shallow-all-suture-fda-510k.jpg K182439 - TruShot with Y-Knot Shallow All-Suture Anchor K182439 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Conmed Corporation. Cleared Jan 2019. https://www.510kdatabase.net/k182630/ 2019-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k182630-omnipod-insulin-management-system-fda-510k.jpg K182630 - Omnipod Insulin Management System, Omnipod DASH Insulin Management System K182630 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Insulet Corporation. Cleared Jan 2019. https://www.510kdatabase.net/k182632/ 2019-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k182632-hs30-diagnostic-ultrasound-system-fda-510k.jpg K182632 - HS30 Diagnostic Ultrasound System K182632 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Medison Co., Ltd.. Cleared Jan 2019. https://www.510kdatabase.net/k182692/ 2019-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k182692-bd-max-ctgctv2-bd-max-system-fda-510k.jpg K182692 - BD MAX CTGCTV2, BD MAX System K182692 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson and Company. Cleared Jan 2019. https://www.510kdatabase.net/k182721/ 2019-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k182721-choice-spine-navigation-system-fda-510k.jpg K182721 - Choice Spine Navigation System K182721 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Choicespine, LP. Cleared Jan 2019. https://www.510kdatabase.net/k182868/ 2019-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k182868-invos-pm7100-patient-monitor-invos-fda-510k.jpg K182868 - INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor K182868 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien, LLC. Cleared Jan 2019. https://www.510kdatabase.net/k180564/ 2019-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k180564-medentika-abutment-system-medentika-fda-510k.jpg K180564 - Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases K180564 is a FDA 510(k) cleared dental medical device. Manufacturer: Medentika GmbH. Cleared Jan 2019. https://www.510kdatabase.net/k182114/ 2019-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k182114-flarehawk-interbody-fusion-system-fda-510k.jpg K182114 - FlareHawk Interbody Fusion System K182114 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Integrity Implants, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k182210/ 2019-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k182210-tiwave-l-porous-titanium-lumbar-cage-fda-510k.jpg K182210 - TiWAVE-L Porous Titanium Lumbar Cage K182210 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Kalitec Medical, LLC. Cleared Jan 2019. https://www.510kdatabase.net/k182305/ 2019-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k182305-stryker-facial-id-plating-system-fda-510k.jpg K182305 - Stryker Facial iD Plating System K182305 is a FDA 510(k) cleared dental medical device. Manufacturer: Stryker. Cleared Jan 2019. https://www.510kdatabase.net/k183470/ 2019-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k183470-precision-ideal-eyes-arthroscopes-fda-510k.jpg K183470 - Precision Ideal Eyes Arthroscopes K183470 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker. Cleared Jan 2019. https://www.510kdatabase.net/k180199/ 2019-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k180199-bio-c-temp-fda-510k.jpg K180199 - BIO-C TEMP K180199 is a FDA 510(k) cleared dental medical device. Manufacturer: Angelus Industria DE Produtos Odontologicos S/A. Cleared Jan 2019. https://www.510kdatabase.net/k180477/ 2019-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k180477-straumann-pure-ceramic-implant-system-fda-510k.jpg K180477 - Straumann PURE Ceramic Implant System K180477 is a FDA 510(k) cleared dental medical device. Manufacturer: Institut Straumann AG. Cleared Jan 2019. https://www.510kdatabase.net/k181053/ 2019-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k181053-care-orchestrator-fda-510k.jpg K181053 - Care Orchestrator K181053 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k181461/ 2019-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k181461-rapid-i-kit-fda-510k.jpg K181461 - Rapid-i™ Kit K181461 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Vitrolife Sweden AB. Cleared Jan 2019. https://www.510kdatabase.net/k182621/ 2019-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k182621-crossft-knotless-deep-thread-suture-fda-510k.jpg K182621 - CrossFT Knotless Deep Thread Suture Anchor with Disposable Driver K182621 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Conmed Corporation. Cleared Jan 2019. https://www.510kdatabase.net/k182675/ 2019-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k182675-polygon-resection-device-fda-510k.jpg K182675 - Polygon Resection Device K182675 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Polygon Medical, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k182982/ 2019-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k182982-bridalveil-navigated-instruments-fda-510k.jpg K182982 - BridalVeil Navigated Instruments K182982 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Astura Medical. Cleared Jan 2019. https://www.510kdatabase.net/k183033/ 2019-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k183033-sensititre-18-24-hour-mic-or-fda-510k.jpg K183033 - Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.03-32ug/ml K183033 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Thermo Fisher Scientific. Cleared Jan 2019. https://www.510kdatabase.net/k183175/ 2019-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k183175-bostonsight-scleral-fda-510k.jpg K183175 - BostonSight Scleral K183175 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Bostonsight. Cleared Jan 2019. https://www.510kdatabase.net/k183256/ 2019-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k183256-glidescope-bflex-single-use-fda-510k.jpg K183256 - GlideScope BFlex Single-Use Bronchoscope System K183256 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Verathon Medical (Canada) Ulc. Cleared Jan 2019. https://www.510kdatabase.net/k183293/ 2019-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k183293-verify-vh202-indicator-tape-fda-510k.jpg K183293 - VERIFY VH202 Indicator Tape K183293 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Jan 2019. https://www.510kdatabase.net/k183295/ 2019-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k183295-celerity-hp-chemical-indicator-ci-fda-510k.jpg K183295 - Celerity HP Chemical Indicator (CI) K183295 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Steris Corporations. Cleared Jan 2019. https://www.510kdatabase.net/k183392/ 2019-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k183392-picolo-ndyag-picosecond-laser-system-fda-510k.jpg K183392 - PicoLO Nd:YAG Picosecond Laser System K183392 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Laseroptek Co., Ltd.. Cleared Jan 2019. https://www.510kdatabase.net/k180139/ 2019-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k180139-safe-secure-sterilization-pouches-and-fda-510k.jpg K180139 - Safe Secure Sterilization Pouches and Rolls K180139 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Safe Secure Packing Co., Ltd.. Cleared Jan 2019. https://www.510kdatabase.net/k180435/ 2019-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k180435-arm-blood-pressure-monitor-fda-510k.jpg K180435 - Arm Blood Pressure Monitor K180435 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Alicn Medical (Shenzhen), Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k180951/ 2019-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k180951-responsive-arthroscopy-suture-anchor-fda-510k.jpg K180951 - Responsive Arthroscopy Suture Anchor System K180951 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Responsive Arthroscopy, LLC. Cleared Jan 2019. https://www.510kdatabase.net/k180983/ 2019-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k180983-maxcon-two-gallon-chemotherapy-container-fda-510k.jpg K180983 - Maxcon Two Gallon Chemotherapy Container K180983 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ningbo Maxcon Medical Technology Co., Ltd.. Cleared Jan 2019. https://www.510kdatabase.net/k180984/ 2019-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k180984-maxcon-sharps-container-fda-510k.jpg K180984 - Maxcon Sharps Container K180984 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ningbo Maxcon Medical Technology Co., Ltd.. Cleared Jan 2019. https://www.510kdatabase.net/k181127/ 2019-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k181127-endorotor-console-endorotor-catheters-fda-510k.jpg K181127 - EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control K181127 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Interscope, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k182568/ 2019-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k182568-v-pro-s2-low-temperature-sterilization-fda-510k.jpg K182568 - V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System K182568 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Jan 2019. https://www.510kdatabase.net/k182741/ 2019-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k182741-sculpsure-fda-510k.jpg K182741 - SculpSure K182741 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cynosure. Cleared Jan 2019. https://www.510kdatabase.net/k182766/ 2019-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k182766-cufitec-surgical-mask-fda-510k.jpg K182766 - Cufitec Surgical Mask K182766 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Nbc Meshtec, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k183143/ 2019-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k183143-uct-520-uct-528-fda-510k.jpg K183143 - uCT 520, uCT 528 K183143 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shangai United Imaging Healthcare Co., Ltd.. Cleared Jan 2019. https://www.510kdatabase.net/k183214/ 2019-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k183214-raven-lumbar-plate-system-fda-510k.jpg K183214 - Raven Lumbar Plate System K183214 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Choicespine, LP. Cleared Jan 2019. https://www.510kdatabase.net/k183294/ 2019-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k183294-celerity-20-hp-biological-indicator-fda-510k.jpg K183294 - CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack K183294 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Jan 2019. https://www.510kdatabase.net/k183297/ 2019-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k183297-vis-u-all-low-temperature-fda-510k.jpg K183297 - Vis-U-All Low Temperature Sterilization Pouch/Tubing K183297 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Jan 2019. https://www.510kdatabase.net/k183300/ 2019-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k183300-verify-v24-self-contained-biological-fda-510k.jpg K183300 - VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack K183300 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Steris Corporations. Cleared Jan 2019. https://www.510kdatabase.net/k183301/ 2019-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k183301-pro-lite-sterilization-tray-fda-510k.jpg K183301 - PRO-LITE Sterilization Tray K183301 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Jan 2019. https://www.510kdatabase.net/k183643/ 2019-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k183643-clear-image-aligners-fda-510k.jpg K183643 - Clear Image Aligners K183643 is a FDA 510(k) cleared dental medical device. Manufacturer: Specialty Appliance Works, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k181215/ 2019-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k181215-infrared-thermometer-fda-510k.jpg K181215 - Infrared Thermometer K181215 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen Finicare Co., Ltd.. Cleared Jan 2019. https://www.510kdatabase.net/k181737/ 2019-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k181737-raycell-mk1-fda-510k.jpg K181737 - Raycell MK1 K181737 is a FDA 510(k) cleared radiology medical device. Manufacturer: Best Theratronics Limited. Cleared Jan 2019. https://www.510kdatabase.net/k181864/ 2019-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k181864-polaris-rf-ablation-system-fda-510k.jpg K181864 - Polaris RF Ablation System K181864 is a FDA 510(k) cleared neurology medical device. Manufacturer: Baylis Medical Company, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k182025/ 2019-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k182025-clearup-sinus-pain-relief-fda-510k.jpg K182025 - ClearUP Sinus Pain Relief K182025 is a FDA 510(k) cleared neurology medical device. Manufacturer: Tivic Health Systems, Inc.. Cleared Jan 2019. https://www.510kdatabase.net/k182199/ 2019-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k182199-nfc-700-non-mydriatic-auto-fundus-camera-fda-510k.jpg K182199 - NFC-700 non-mydriatic auto fundus camera K182199 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Crystalvue Medical Corporation. Cleared Jan 2019. https://www.510kdatabase.net/k182855/ 2019-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k182855-proknow-ds-fda-510k.jpg K182855 - ProKnow DS K182855 is a FDA 510(k) cleared radiology medical device. Manufacturer: Proknow, LLC. Cleared Jan 2019. https://www.510kdatabase.net/k183352/ 2019-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k183352-optimus-neuro-system-fda-510k.jpg K183352 - Optimus Neuro System K183352 is a FDA 510(k) cleared neurology medical device. Manufacturer: Osteonic Co., Ltd.. Cleared Jan 2019. https://www.510kdatabase.net/k183476/ 2019-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k183476-3m-filtek-universal-restorative-fda-510k.jpg K183476 - 3M Filtek Universal Restorative K183476 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Espe Dental Products. Cleared Jan 2019. https://www.510kdatabase.net/k183542/ 2019-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k183542-signature-orthodontic-system-fda-510k.jpg K183542 - Signature Orthodontic System K183542 is a FDA 510(k) cleared dental medical device. Manufacturer: Signature Orthodontics. Cleared Jan 2019. https://www.510kdatabase.net/k183101/ 2018-12-31 monthly 0.5 https://www.510kdatabase.net/og-image/k183101-zenition-50-fda-510k.jpg K183101 - Zenition 50 K183101 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Dec 2018. https://www.510kdatabase.net/k183000/ 2018-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k183000-vipercath-xc-peripheral-exchange-fda-510k.jpg K183000 - ViperCath XC Peripheral Exchange Catheter K183000 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cardiovascular Systems, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k180204/ 2018-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k180204-craniomaxillofacial-fixation-cmf-fda-510k.jpg K180204 - CranioMaxillofacial Fixation (CMF) System - CMF Visionare K180204 is a FDA 510(k) cleared dental medical device. Manufacturer: Visionare, LLC. Cleared Dec 2018. https://www.510kdatabase.net/k180867/ 2018-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k180867-amcad-uo-fda-510k.jpg K180867 - AmCAD-UO K180867 is a FDA 510(k) cleared radiology medical device. Manufacturer: Amcad Biomed Corporation. Cleared Dec 2018. https://www.510kdatabase.net/k181703/ 2018-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k181703-straumann-blx-line-extension-implants-fda-510k.jpg K181703 - Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments K181703 is a FDA 510(k) cleared dental medical device. Manufacturer: Institut Straumann AG. Cleared Dec 2018. https://www.510kdatabase.net/k182736/ 2018-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k182736-oic-suture-anchor-system-fda-510k.jpg K182736 - OIC Suture Anchor System K182736 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: The Orthopaedic Implant Company. Cleared Dec 2018. https://www.510kdatabase.net/k183369/ 2018-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k183369-cor12-ecg-fda-510k.jpg K183369 - COR12 ECG K183369 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Corscience GmbH & Co.. Cleared Dec 2018. https://www.510kdatabase.net/den170091/ 2018-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/den170091-eyebox-fda-510k.jpg DEN170091 - EyeBOX DEN170091 is a FDA 510(k) cleared neurology medical device. Manufacturer: Oculogica, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k182045/ 2018-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k182045-lotus-iii-multi-pulsed-er-yag-laser-fda-510k.jpg K182045 - Lotus III Multi-Pulsed Er: Yag Laser System K182045 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Laseroptek Co., Ltd.. Cleared Dec 2018. https://www.510kdatabase.net/k182130/ 2018-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k182130-ischemaview-rapid-fda-510k.jpg K182130 - iSchemaView RAPID K182130 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ischemaview, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k182404/ 2018-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k182404-sterrad-velocity-biological-indicator-fda-510k.jpg K182404 - STERRAD VELOCITY Biological Indicator K182404 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Advanced Sterilization Products (Asp). Cleared Dec 2018. https://www.510kdatabase.net/k182461/ 2018-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k182461-latitude-ev-total-elbow-arthroplasty-fda-510k.jpg K182461 - LATITUDE EV Total Elbow Arthroplasty K182461 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tornier, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k182564/ 2018-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k182564-quantib-nd-fda-510k.jpg K182564 - Quantib ND K182564 is a FDA 510(k) cleared radiology medical device. Manufacturer: Quantib B.V.. Cleared Dec 2018. https://www.510kdatabase.net/k182845/ 2018-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k182845-minisono-fda-510k.jpg K182845 - minisono K182845 is a FDA 510(k) cleared radiology medical device. Manufacturer: Alpinion Medical Systems Co., Ltd.. Cleared Dec 2018. https://www.510kdatabase.net/k183169/ 2018-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k183169-pulse-20-pulse-pro-20-fda-510k.jpg K183169 - Pulse 2.0, Pulse Pro 2.0 K183169 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: NormaTec Industries, LP. Cleared Dec 2018. https://www.510kdatabase.net/k181761/ 2018-12-26 monthly 0.5 https://www.510kdatabase.net/og-image/k181761-zimmer-biomet-select-ceramic-heads-fda-510k.jpg K181761 - Zimmer Biomet Select Ceramic Heads K181761 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k182099/ 2018-12-26 monthly 0.5 https://www.510kdatabase.net/og-image/k182099-delta-tt-pro-fda-510k.jpg K182099 - Delta TT Pro K182099 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Lima Corporate S.P.A.. Cleared Dec 2018. https://www.510kdatabase.net/k182242/ 2018-12-26 monthly 0.5 https://www.510kdatabase.net/og-image/k182242-vo200-neuros-cerebral-oximetry-system-fda-510k.jpg K182242 - VO200 – NeurOs Cerebral Oximetry System K182242 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Mespere Lifesciences, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k182698/ 2018-12-26 monthly 0.5 https://www.510kdatabase.net/og-image/k182698-liaison-calprotectin-liaison-fda-510k.jpg K182698 - LIAISON Calprotectin, LIAISON Calprotectin Control Set, LIAISON Calprotectin Calibration Verifiers, LIAISON Q.S.E.T. Buffer, LIAISON Q.S.E.T. Device K182698 is a FDA 510(k) cleared immunology medical device. Manufacturer: DiaSorin, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k182709/ 2018-12-26 monthly 0.5 https://www.510kdatabase.net/og-image/k182709-one-step-suprapubic-introducer-fda-510k.jpg K182709 - One-Step Suprapubic Introducer K182709 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Dec 2018. https://www.510kdatabase.net/k182783/ 2018-12-26 monthly 0.5 https://www.510kdatabase.net/og-image/k182783-depuy-synthes-trauma-orthopedic-nail-fda-510k.jpg K182783 - DePuy Synthes Trauma Orthopedic Nail Implants K182783 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Synthes. Cleared Dec 2018. https://www.510kdatabase.net/k181641/ 2018-12-24 monthly 0.5 https://www.510kdatabase.net/og-image/k181641-quikclot-radial-fda-510k.jpg K181641 - QuikClot Radial K181641 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Z-Medica, LLC. Cleared Dec 2018. https://www.510kdatabase.net/k183007/ 2018-12-24 monthly 0.5 https://www.510kdatabase.net/og-image/k183007-elia-smdp-immunoassay-fda-510k.jpg K183007 - EliA SmDP Immunoassay K183007 is a FDA 510(k) cleared immunology medical device. Manufacturer: Phadia AB. Cleared Dec 2018. https://www.510kdatabase.net/k173036/ 2018-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k173036-north-vision-multi-parameter-patient-fda-510k.jpg K173036 - North-vision Multi-parameter Patient Monitor K173036 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: North-Vision Tech., Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k173747/ 2018-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k173747-rexlene-fda-510k.jpg K173747 - REXLENE K173747 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sm Eng Co., Ltd.. Cleared Dec 2018. https://www.510kdatabase.net/k180014/ 2018-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k180014-creme-de-la-femme-feminine-lubricant-fda-510k.jpg K180014 - Creme de La Femme Feminine Lubricant K180014 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Cewal, Inc. Dba Premiere Enterprises. Cleared Dec 2018. https://www.510kdatabase.net/k180380/ 2018-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k180380-vital-signs-monitor-fda-510k.jpg K180380 - vital signs monitor K180380 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edan Instruments, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k180821/ 2018-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k180821-trumatch-graft-cage-long-bone-fda-510k.jpg K180821 - TruMatch Graft Cage - Long Bone K180821 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa), LLC. Cleared Dec 2018. https://www.510kdatabase.net/k180826/ 2018-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k180826-natrelle-133-plus-microcell-tissue-fda-510k.jpg K180826 - Natrelle 133 Plus MICROCELL Tissue Expander K180826 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Allergan. Cleared Dec 2018. https://www.510kdatabase.net/k181037/ 2018-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k181037-dio-cadcam-abutment-fda-510k.jpg K181037 - DIO CAD/CAM Abutment K181037 is a FDA 510(k) cleared dental medical device. Manufacturer: Dio Corporation. Cleared Dec 2018. https://www.510kdatabase.net/k181120/ 2018-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k181120-28-mm33-mm-poplok-suture-anchors-fda-510k.jpg K181120 - 2.8 mm/3.3 mm PopLok Suture Anchors K181120 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Conmed Corporation. Cleared Dec 2018. https://www.510kdatabase.net/k181331/ 2018-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k181331-juvora-oyster-white-dental-disc-fda-510k.jpg K181331 - JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White K181331 is a FDA 510(k) cleared dental medical device. Manufacturer: Juvora, Ltd.. Cleared Dec 2018. https://www.510kdatabase.net/k181412/ 2018-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k181412-vitek-ms-fda-510k.jpg K181412 - VITEK MS K181412 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k181555/ 2018-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k181555-arthrex-fracture-adapter-hemi-shoulder-fda-510k.jpg K181555 - Arthrex Fracture Adapter Hemi Shoulder Prosthesis K181555 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k181690/ 2018-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k181690-clear-jet-injection-catheter-fda-510k.jpg K181690 - Clear-Jet Injection Catheter K181690 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Finemedix Co., Ltd.. Cleared Dec 2018. https://www.510kdatabase.net/k181752/ 2018-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k181752-stryker-ivas-elite-inflatable-fda-510k.jpg K181752 - Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter) K181752 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Corporation. Cleared Dec 2018. https://www.510kdatabase.net/k182012/ 2018-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k182012-advia-centaur-calcitonin-calct-assay-fda-510k.jpg K182012 - ADVIA Centaur Calcitonin (CALCT) assay K182012 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Axis-Shield Diagnostics Limited. Cleared Dec 2018. https://www.510kdatabase.net/k182032/ 2018-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k182032-sterilcontainer-s-system-fda-510k.jpg K182032 - SterilContainer S System K182032 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Aesculap, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k182167/ 2018-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k182167-the-ichor-panacea-vascular-embolectomy-fda-510k.jpg K182167 - The ICHOR Panacea Vascular Embolectomy Catheter System K182167 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ichor Vascular, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k182682/ 2018-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k182682-orthogold-100-fda-510k.jpg K182682 - OrthoGold 100 K182682 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Tissue Regeneration Technologies. Cleared Dec 2018. https://www.510kdatabase.net/k182690/ 2018-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k182690-eplex-blood-culture-identification-fda-510k.jpg K182690 - ePlex Blood Culture Identification Panel Fungal Pathogen (BCID-FP) Panel K182690 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Genmark Diagnostics, Incorporated. Cleared Dec 2018. https://www.510kdatabase.net/k182750/ 2018-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k182750-4d-view-fda-510k.jpg K182750 - 4D View K182750 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared Dec 2018. https://www.510kdatabase.net/k182755/ 2018-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k182755-disposable-temperature-probe-fda-510k.jpg K182755 - Disposable Temperature Probe K182755 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen Caremed Medical Technology Co., Ltd.. Cleared Dec 2018. https://www.510kdatabase.net/k182776/ 2018-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k182776-neocis-guidance-system-fda-510k.jpg K182776 - Neocis Guidance System K182776 is a FDA 510(k) cleared dental medical device. Manufacturer: Neocis, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k182781/ 2018-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k182781-pts-professional-chemistry-kit-fda-510k.jpg K182781 - PTS Professional Chemistry Kit K182781 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Polymer Technology Systems, Inc. D/B/A Pts Diagnostics. Cleared Dec 2018. https://www.510kdatabase.net/k182795/ 2018-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k182795-lensar-laser-system-fs-3d-lls-fs-3d-fda-510k.jpg K182795 - LENSAR Laser System - fs 3D (LLS-fs 3D) K182795 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Lensar, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k183012/ 2018-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k183012-vascucap-fda-510k.jpg K183012 - vascuCAP K183012 is a FDA 510(k) cleared radiology medical device. Manufacturer: Elucid Bioimaging, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k183059/ 2018-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k183059-3nethra-neo-fda-510k.jpg K183059 - 3nethra neo K183059 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Forus Health Pvt.Ltd. Cleared Dec 2018. https://www.510kdatabase.net/k183068/ 2018-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k183068-nitrile-glove-powder-free-white-fda-510k.jpg K183068 - Nitrile Glove Powder Free White K183068 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Haining Medical Products Co., Ltd.. Cleared Dec 2018. https://www.510kdatabase.net/k183328/ 2018-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k183328-pulse-rx-20-pulse-pro-rx-20-fda-510k.jpg K183328 - Pulse Rx 2.0, Pulse Pro Rx 2.0 K183328 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: NormaTec Industries, LP. Cleared Dec 2018. https://www.510kdatabase.net/den170070/ 2018-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/den170070-mll-kmt2a-breakapart-fish-probe-kit-fda-510k.jpg DEN170070 - MLL (KMT2A) Breakapart FISH Probe Kit DEN170070 is a FDA 510(k) cleared medical genetics medical device. Manufacturer: Cytocell, Ltd.. Cleared Dec 2018. https://www.510kdatabase.net/den180007/ 2018-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/den180007-miris-human-milk-analyzer-fda-510k.jpg DEN180007 - Miris Human Milk Analyzer DEN180007 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miris AB. Cleared Dec 2018. https://www.510kdatabase.net/k162553/ 2018-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k162553-airspiral-heated-breathing-tube-fda-510k.jpg K162553 - AirSpiral Heated Breathing Tube K162553 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Fisher & Paykel Healthcare. Cleared Dec 2018. https://www.510kdatabase.net/k173041/ 2018-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k173041-3diemme-realguide-fda-510k.jpg K173041 - 3DIEMME RealGUIDE K173041 is a FDA 510(k) cleared radiology medical device. Manufacturer: 3Diemme , Ltd.. Cleared Dec 2018. https://www.510kdatabase.net/k180828/ 2018-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k180828-natureplex-warm-touch-warming-jelly-fda-510k.jpg K180828 - Natureplex Warm Touch Warming Jelly K180828 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Natureplex, LLC. Cleared Dec 2018. https://www.510kdatabase.net/k180830/ 2018-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k180830-reuter-tip-deflecting-wire-guide-fda-510k.jpg K180830 - Reuter Tip Deflecting Wire Guide K180830 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Dec 2018. https://www.510kdatabase.net/k181589/ 2018-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k181589-curiteva-lumbar-interbody-fusion-system-fda-510k.jpg K181589 - Curiteva Lumbar Interbody Fusion System K181589 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Curiteva, LLC. Cleared Dec 2018. https://www.510kdatabase.net/k181663/ 2018-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k181663-eplex-blood-culture-identification-fda-510k.jpg K181663 - ePlex Blood Culture Identification Panel - Gram Positive (BCID-GP) Panel K181663 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Genmark Diagnostics, Incorporated. Cleared Dec 2018. https://www.510kdatabase.net/k181838/ 2018-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k181838-sinusway-dilation-system-fda-510k.jpg K181838 - Sinusway Dilation System K181838 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: 3nt Medical , Ltd.. Cleared Dec 2018. https://www.510kdatabase.net/k181861/ 2018-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k181861-embrace-fda-510k.jpg K181861 - Embrace K181861 is a FDA 510(k) cleared neurology medical device. Manufacturer: Empatica S.R.L.. Cleared Dec 2018. https://www.510kdatabase.net/k182165/ 2018-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k182165-color-doppler-ultrasound-system-fda-510k.jpg K182165 - Color Doppler Ultrasound System K182165 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Well.D Medical Electronics Co., Ltd.. Cleared Dec 2018. https://www.510kdatabase.net/k182320/ 2018-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k182320-bd-contoured-base-pen-needle-fda-510k.jpg K182320 - BD Contoured Base Pen Needle K182320 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson and Company. Cleared Dec 2018. https://www.510kdatabase.net/k182420/ 2018-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k182420-asahi-corsair-pro-xs-fda-510k.jpg K182420 - ASAHI Corsair Pro XS K182420 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Asahi Intecc Co., Ltd.. Cleared Dec 2018. https://www.510kdatabase.net/k182454/ 2018-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k182454-o2-concepts-oxlife-independence-model-fda-510k.jpg K182454 - O2 Concepts Oxlife Independence Model 301-0001 K182454 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: O2 Concepts, LLC. Cleared Dec 2018. https://www.510kdatabase.net/k182670/ 2018-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k182670-fibergraft-aeridyan-matrix-bone-graft-fda-510k.jpg K182670 - FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute K182670 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Prosidyan, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k182972/ 2018-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k182972-phoenix-atherectomy-system-fda-510k.jpg K182972 - Phoenix Atherectomy System K182972 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Volcano Atheromed, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k183036/ 2018-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k183036-dilator-sets-fda-510k.jpg K183036 - Dilator Sets K183036 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Dec 2018. https://www.510kdatabase.net/k183115/ 2018-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k183115-mts-levofloxacin-0002-32-gml-fda-510k.jpg K183115 - MTS Levofloxacin 0.002 - 32 µg/mL K183115 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Liofilchem S. R. L.. Cleared Dec 2018. https://www.510kdatabase.net/k183123/ 2018-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k183123-microtargeting-guideline-4000-50-system-fda-510k.jpg K183123 - microTargeting Guideline 4000 5.0 System K183123 is a FDA 510(k) cleared neurology medical device. Manufacturer: FHC, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k183267/ 2018-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k183267-dyevert-ng-contrast-reduction-system-fda-510k.jpg K183267 - DyeVert™ NG Contrast Reduction System, DyeVert™ PLUS EZ Contrast Reduction System, DyeTect™ Contrast Monitoring Disposable Kit, Smart Syringe, DyeVert™ PLUS EZ Contrast Reduction System K183267 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Osprey Medical, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/den170021/ 2018-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/den170021-sem-scanner-model-200-fda-510k.jpg DEN170021 - SEM Scanner (Model 200) DEN170021 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Bruin Biometrics, LLC. Cleared Dec 2018. https://www.510kdatabase.net/den170072/ 2018-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/den170072-enlight-1810-fda-510k.jpg DEN170072 - Enlight 1810 DEN170072 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Timpel, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k173140/ 2018-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k173140-vivachek-ino-smart-blood-glucose-fda-510k.jpg K173140 - VivaChek Ino Smart Blood Glucose Monitoring System, VivaChek Ino Sync Blood Glucose Monitoring System, VivaChek Ino Sound Blood Glucose Monitoring System, VivaChek Ino Plus Blood Glucose Monitoring System, VivaChek Ino Sound Simple Blood Glucose Monitoring System, VivaChek Ino Sound Bright Blood Glucose Monitoring System K173140 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Vivachek Laboratories, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k180846/ 2018-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k180846-arterial-pressure-monitoring-settray-fda-510k.jpg K180846 - Arterial Pressure Monitoring Set/Tray K180846 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Dec 2018. https://www.510kdatabase.net/k180863/ 2018-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k180863-fora-nas100-electronic-nasal-aspirator-fda-510k.jpg K180863 - FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator K180863 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Taidoc Technology Corporation. Cleared Dec 2018. https://www.510kdatabase.net/k181785/ 2018-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k181785-modified-brainscope-one-fda-510k.jpg K181785 - Modified BrainScope One K181785 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainscope Company, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k182116/ 2018-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k182116-ba310-abutment-bia310-implantabutment-fda-510k.jpg K182116 - BA310 Abutment, BIA310 Implant/Abutment K182116 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Cochlear Americas. Cleared Dec 2018. https://www.510kdatabase.net/k182149/ 2018-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k182149-ffrangio-system-fda-510k.jpg K182149 - FFRangio System K182149 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cathworks, Ltd.. Cleared Dec 2018. https://www.510kdatabase.net/k182190/ 2018-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k182190-fetal-doppler-fda-510k.jpg K182190 - Fetal Doppler K182190 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shenzhen AOJ Medical Technology Co., Ltd.. Cleared Dec 2018. https://www.510kdatabase.net/k182446/ 2018-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k182446-trushot-with-y-knot-all-suture-anchor-fda-510k.jpg K182446 - TruShot with Y-Knot All-Suture Anchor K182446 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Conmed Corporation. Cleared Dec 2018. https://www.510kdatabase.net/k182610/ 2018-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k182610-valleylab-ft10-electrosurgical-fda-510k.jpg K182610 - Valleylab FT10 Electrosurgical Platform, Cardioblate BP2 Surgical Ablation Device, Cardioblate LP Surgical Ablation Device K182610 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic. Cleared Dec 2018. https://www.510kdatabase.net/k183223/ 2018-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k183223-simplexa-bordetella-direct-simplexa-fda-510k.jpg K183223 - Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack K183223 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Diasorin Molecular, LLC. Cleared Dec 2018. https://www.510kdatabase.net/k183239/ 2018-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k183239-corelink-f3d-lateral-system-fda-510k.jpg K183239 - CoreLink F3D™ Lateral System K183239 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corelink, LLC. Cleared Dec 2018. https://www.510kdatabase.net/k180909/ 2018-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k180909-revel-spacers-fda-510k.jpg K180909 - REVEL Spacers K180909 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k181087/ 2018-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k181087-apex-locator-dpex-iii-fda-510k.jpg K181087 - Apex Locator, DPEX III K181087 is a FDA 510(k) cleared dental medical device. Manufacturer: Guilin Woodpecker Medical Instrument Co., Ltd.. Cleared Dec 2018. https://www.510kdatabase.net/k181496/ 2018-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k181496-vintage-pro-fda-510k.jpg K181496 - VINTAGE PRO K181496 is a FDA 510(k) cleared dental medical device. Manufacturer: Shofu Dental Corporation. Cleared Dec 2018. https://www.510kdatabase.net/k181756/ 2018-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k181756-gangi-softguard-coaxial-needle-gangi-fda-510k.jpg K181756 - Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle K181756 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Apriomed AB. Cleared Dec 2018. https://www.510kdatabase.net/k182150/ 2018-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k182150-devon-52-sequential-compression-device-fda-510k.jpg K182150 - Devon 52 Sequential Compression Device K182150 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Devon Medical Products (Jiangsu), Ltd.. Cleared Dec 2018. https://www.510kdatabase.net/k182361/ 2018-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k182361-arthrex-compression-ft-screws-fda-510k.jpg K182361 - Arthrex Compression FT Screws K182361 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k182422/ 2018-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k182422-lucitone-denture-base-materials-fda-510k.jpg K182422 - Lucitone Denture Base Materials K182422 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona. Cleared Dec 2018. https://www.510kdatabase.net/k182424/ 2018-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k182424-nuface-fix-skin-toning-device-fda-510k.jpg K182424 - NuFACE FIX Skin Toning Device K182424 is a FDA 510(k) cleared neurology medical device. Manufacturer: Carol Cole Company Dba Nuface. Cleared Dec 2018. https://www.510kdatabase.net/k182593/ 2018-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k182593-ket-1-blood-ketone-monitoring-system-fda-510k.jpg K182593 - KET-1 Blood Ketone Monitoring System K182593 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Apex BioTechnology Corp.. Cleared Dec 2018. https://www.510kdatabase.net/k182595/ 2018-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k182595-hera-w10-diagnostic-ultrasound-system-fda-510k.jpg K182595 - HERA W10 Diagnostic Ultrasound System K182595 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Medison Co., Ltd.. Cleared Dec 2018. https://www.510kdatabase.net/k182624/ 2018-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k182624-mim-mrt-dosimetry-fda-510k.jpg K182624 - MIM - MRT Dosimetry K182624 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mim Software, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k182688/ 2018-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k182688-skr-3000-fda-510k.jpg K182688 - SKR 3000 K182688 is a FDA 510(k) cleared radiology medical device. Manufacturer: Konica Minolta, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k182747/ 2018-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k182747-elia-rf-igm-immunoassay-fda-510k.jpg K182747 - EliA RF IgM Immunoassay K182747 is a FDA 510(k) cleared immunology medical device. Manufacturer: Phadia AB. Cleared Dec 2018. https://www.510kdatabase.net/k182878/ 2018-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k182878-integra-salto-total-ankle-system-fda-510k.jpg K182878 - Integra Salto Total Ankle System K182878 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ascension Orthopedics. Cleared Dec 2018. https://www.510kdatabase.net/k182938/ 2018-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k182938-emission-computed-tomography-system-fda-510k.jpg K182938 - Emission Computed Tomography System K182938 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Dec 2018. https://www.510kdatabase.net/k182989/ 2018-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k182989-aurora-screw-system-fda-510k.jpg K182989 - AURORA™ Screw System K182989 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: MiRus, LLC. Cleared Dec 2018. https://www.510kdatabase.net/k183185/ 2018-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k183185-riptide-aspiration-system-riptide-fda-510k.jpg K183185 - Riptide Aspiration System (Riptide Large Bore Aspiration System) K183185 is a FDA 510(k) cleared neurology medical device. Manufacturer: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. Cleared Dec 2018. https://www.510kdatabase.net/k183253/ 2018-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k183253-valpro-2-plus-vapro-2-plus-pocket-fda-510k.jpg K183253 - ValPro 2 Plus, VaPro 2 Plus Pocket K183253 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hollister Incorporated. Cleared Dec 2018. https://www.510kdatabase.net/k172965/ 2018-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k172965-handheld-vitalsigns-monitoring-system-fda-510k.jpg K172965 - Handheld VitalSigns Monitoring System K172965 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Visiomed Technology Co.,Ltd. Cleared Dec 2018. https://www.510kdatabase.net/k180772/ 2018-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k180772-met-one-czar-anterior-cervical-plate-fda-510k.jpg K180772 - Met One Czar Anterior Cervical Plate System K180772 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Met One Technologies. Cleared Dec 2018. https://www.510kdatabase.net/k180878/ 2018-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k180878-bio-venture-rapid-amphetamine-test-fda-510k.jpg K180878 - BIO-VENTURE Rapid Amphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Oxazepam Test Cassette for OTC Use, BIO-VENTURE Rapid Cocaine Test Cassette for OTC Use, BIO-VENTURE Rapid Methamphetamine Test Cassette for OTC Use, BIO-VENTURE Rapid Morphine Test Cassette for OTC Use, BIO-VENTURE Rapid Marijuana Test Cassette for OTC Use, BIO-VENTURE Rapid Amphetamine Test Cassette for Rx Use, BIO-VENTURE Rapid Oxazepam Test Cassette for Rx Use, BIO-VENTURE Rapid Cocaine Test Cassette for Rx K180878 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Shanghai Venture Bio-Tech Co., Ltd.. Cleared Dec 2018. https://www.510kdatabase.net/k181612/ 2018-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k181612-tyto-stethoscope-otc-fda-510k.jpg K181612 - Tyto Stethoscope (OTC) K181612 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Tyto Care , Ltd.. Cleared Dec 2018. https://www.510kdatabase.net/k181877/ 2018-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k181877-phoenix-24mm-atherectomy-plus-system-fda-510k.jpg K181877 - Phoenix 2.4mm Atherectomy Plus System K181877 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Volcano Atheromed, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k182001/ 2018-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k182001-acucy-influenza-ab-test-with-the-acucy-fda-510k.jpg K182001 - Acucy Influenza A&B Test with the Acucy System K182001 is a FDA 510(k) cleared microbiology medical device. Manufacturer: SEKISUI Diagnostics, LLC. Cleared Dec 2018. https://www.510kdatabase.net/k182387/ 2018-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k182387-novopen-echo-dial-a-dose-insulin-fda-510k.jpg K182387 - NovoPen Echo Dial-A-Dose Insulin Delivery Device (Pen Injector) K182387 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Novo Nordisk, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k182433/ 2018-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k182433-reusable-blood-pressure-cuff-fda-510k.jpg K182433 - Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff K182433 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Caremed Medical Technology Co., Ltd.. Cleared Dec 2018. https://www.510kdatabase.net/k183198/ 2018-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k183198-flowtriever-retrievalaspiration-system-fda-510k.jpg K183198 - FlowTriever Retrieval/Aspiration System K183198 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inari Medical. Cleared Dec 2018. https://www.510kdatabase.net/k183348/ 2018-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k183348-reusable-silicone-cover-cprmeter-2-fda-510k.jpg K183348 - Reusable Silicone Cover CPRmeter 2 K183348 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Laerdal Medical AS. Cleared Dec 2018. https://www.510kdatabase.net/k173783/ 2018-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k173783-scig60-infusion-system-fda-510k.jpg K173783 - SCIg60 Infusion System K173783 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Emed Technologies Corporation. Cleared Dec 2018. https://www.510kdatabase.net/k180762/ 2018-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k180762-capi-3-hemoglobine-fda-510k.jpg K180762 - CAPI 3 HEMOGLOBIN(E) K180762 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sebia. Cleared Dec 2018. https://www.510kdatabase.net/k180768/ 2018-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k180768-arthrex-swivelock-anchors-fda-510k.jpg K180768 - Arthrex SwiveLock Anchors K180768 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k180797/ 2018-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k180797-xcess-guiding-catheter-fda-510k.jpg K180797 - Xcess Guiding Catheter K180797 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Curatia Medical Co.. Cleared Dec 2018. https://www.510kdatabase.net/k180820/ 2018-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k180820-tono-vue-non-contact-tonometer-fda-510k.jpg K180820 - Tono Vue Non-Contact Tonometer K180820 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Crystalvue Medical Corporation. Cleared Dec 2018. https://www.510kdatabase.net/k180879/ 2018-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k180879-bio-venture-rapid-multi-drug-test-easy-fda-510k.jpg K180879 - BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx Use K180879 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Shanghai Venture Bio-Tech Co., Ltd.. Cleared Dec 2018. https://www.510kdatabase.net/k181269/ 2018-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k181269-icertainty-fda-510k.jpg K181269 - iCertainty K181269 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Rfpi. Cleared Dec 2018. https://www.510kdatabase.net/k181294/ 2018-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k181294-honda-walking-assist-device-fda-510k.jpg K181294 - Honda Walking Assist Device K181294 is a FDA 510(k) cleared neurology medical device. Manufacturer: Honda Motor Company, Ltd.. Cleared Dec 2018. https://www.510kdatabase.net/k181344/ 2018-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k181344-ctm-mobility-scooter-fda-510k.jpg K181344 - C.T.M Mobility Scooter K181344 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Chien TI Enterprise Co., Ltd.. Cleared Dec 2018. https://www.510kdatabase.net/k181374/ 2018-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k181374-nrfit-syringe-fda-510k.jpg K181374 - NRFit Syringe K181374 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Caina Medical Co.,Ltd. Cleared Dec 2018. https://www.510kdatabase.net/k181827/ 2018-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k181827-affixus-natural-nail-system-humeral-nail-fda-510k.jpg K181827 - Affixus Natural Nail System Humeral Nail K181827 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer GmbH. Cleared Dec 2018. https://www.510kdatabase.net/k181865/ 2018-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k181865-acu-sinq-complete-endoscope-cleaning-fda-510k.jpg K181865 - Acu-sInQ Complete Endoscope Cleaning Aid System K181865 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Dec 2018. https://www.510kdatabase.net/k182008/ 2018-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k182008-phasix-st-mesh-with-echo-2-positioning-fda-510k.jpg K182008 - Phasix ST Mesh with Echo 2 Positioning System K182008 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k182194/ 2018-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k182194-uv-active-implant-system-fda-510k.jpg K182194 - UV Active Implant System K182194 is a FDA 510(k) cleared dental medical device. Manufacturer: Dio Corporation. Cleared Dec 2018. https://www.510kdatabase.net/k182207/ 2018-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k182207-tr90bh-fda-510k.jpg K182207 - TR90BH K182207 is a FDA 510(k) cleared radiology medical device. Manufacturer: Minxray, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k182296/ 2018-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k182296-hyperfil-lv-fda-510k.jpg K182296 - HyperFil-LV K182296 is a FDA 510(k) cleared dental medical device. Manufacturer: Parkell, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k182354/ 2018-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k182354-safeair-telescopic-smoke-pencil-fda-510k.jpg K182354 - SafeAir Telescopic Smoke Pencil K182354 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lina Medical Aps. Cleared Dec 2018. https://www.510kdatabase.net/k182419/ 2018-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k182419-centricity-universal-viewer-fda-510k.jpg K182419 - Centricity Universal Viewer K182419 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Dec 2018. https://www.510kdatabase.net/k182556/ 2018-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k182556-sureclip-repositionable-hemostasis-clip-fda-510k.jpg K182556 - SureClip Repositionable Hemostasis Clip K182556 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Micro-Tech (Nanjing) Co., Ltd.. Cleared Dec 2018. https://www.510kdatabase.net/k182601/ 2018-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k182601-vitrea-software-package-vstp-001a-fda-510k.jpg K182601 - Vitrea Software Package, VSTP-001A K182601 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Dec 2018. https://www.510kdatabase.net/k182668/ 2018-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k182668-rapid-reboot-compression-therapy-system-fda-510k.jpg K182668 - Rapid Reboot Compression Therapy System K182668 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Rapid Reboot Recovery Products, LLC. Cleared Dec 2018. https://www.510kdatabase.net/k182681/ 2018-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k182681-ac5-topical-gel-fda-510k.jpg K182681 - AC5 Topical Gel K182681 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Arch Therapeutics, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k182790/ 2018-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k182790-cardio-tritest-v65-fda-510k.jpg K182790 - Cardio-TriTest v6.5 K182790 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cardio-Phoenix, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k182805/ 2018-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k182805-rct800-fda-510k.jpg K182805 - RCT800 K182805 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ray Co., Ltd.. Cleared Dec 2018. https://www.510kdatabase.net/k182900/ 2018-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k182900-3880-mri-patient-monitoring-system-fda-510k.jpg K182900 - 3880 MRI Patient Monitoring System K182900 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Iradimed Corporation. Cleared Dec 2018. https://www.510kdatabase.net/k182905/ 2018-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k182905-unipulse-fda-510k.jpg K182905 - UniPulse K182905 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Seaward Group. Cleared Dec 2018. https://www.510kdatabase.net/k182922/ 2018-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k182922-mts-omadacycline-0002-32-gml-fda-510k.jpg K182922 - MTS Omadacycline 0.002-32 µg/mL K182922 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Liofilchem S. R. L.. Cleared Dec 2018. https://www.510kdatabase.net/k183162/ 2018-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k183162-affixus-hip-fracture-nail-fda-510k.jpg K183162 - Affixus Hip Fracture Nail K183162 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k180359/ 2018-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k180359-btl-fr2000-fda-510k.jpg K180359 - BTL-FR2000 K180359 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: BTL Industries, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k180859/ 2018-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k180859-pyramidion-dental-implants-and-fda-510k.jpg K180859 - PYRAMIDION Dental Implants and Prostheses K180859 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentack Implants, Ltd.. Cleared Dec 2018. https://www.510kdatabase.net/k181131/ 2018-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k181131-accu-chek-guide-me-blood-glucose-fda-510k.jpg K181131 - Accu-Chek Guide Me Blood Glucose Monitoring System K181131 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diabetes Care. Cleared Dec 2018. https://www.510kdatabase.net/k181372/ 2018-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k181372-argos-fda-510k.jpg K181372 - Argos K181372 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Retia Medical, LLC. Cleared Dec 2018. https://www.510kdatabase.net/k181463/ 2018-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k181463-durasheath-introducer-sheath-system-fda-510k.jpg K181463 - DuraSheath Introducer Sheath System K181463 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Contract Medical International, GmbH. Cleared Dec 2018. https://www.510kdatabase.net/k181824/ 2018-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k181824-cbt-screw-fixation-system-fda-510k.jpg K181824 - CBT Screw Fixation System K181824 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: U&I Corporation. Cleared Dec 2018. https://www.510kdatabase.net/k181899/ 2018-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k181899-roccia-plif-fda-510k.jpg K181899 - ROCCIA® PLIF K181899 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Silony Medical GmbH. Cleared Dec 2018. https://www.510kdatabase.net/k182065/ 2018-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k182065-evolux-cadcam-pmma-blocks-fda-510k.jpg K182065 - EVOLUX CAD/CAM PMMA BLOCKS K182065 is a FDA 510(k) cleared dental medical device. Manufacturer: Blue Dent Dental. Cleared Dec 2018. https://www.510kdatabase.net/k182068/ 2018-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k182068-erran-dental-zirconia-fda-510k.jpg K182068 - Erran Dental Zirconia K182068 is a FDA 510(k) cleared dental medical device. Manufacturer: Hangzhou Erran Technology Co., Ltd.. Cleared Dec 2018. https://www.510kdatabase.net/k182178/ 2018-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k182178-neoblue-blanket-led-phototherapy-system-fda-510k.jpg K182178 - neoBLUE blanket LED Phototherapy System K182178 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Natus Medical Incorporated. Cleared Dec 2018. https://www.510kdatabase.net/k182359/ 2018-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k182359-hipcheck-fda-510k.jpg K182359 - HipCheck K182359 is a FDA 510(k) cleared radiology medical device. Manufacturer: Stryker Corp.. Cleared Dec 2018. https://www.510kdatabase.net/k182397/ 2018-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k182397-diamondback-360-peripheral-orbital-fda-510k.jpg K182397 - Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series K182397 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cardiovascular Systems, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k182434/ 2018-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k182434-laparoguard-fda-510k.jpg K182434 - LaparoGuard K182434 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Mariner Endosurgery, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k182549/ 2018-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k182549-statstrip-xpress-2-glucose-hospital-fda-510k.jpg K182549 - StatStrip Xpress 2 Glucose Hospital Meter System K182549 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Nova Biomedical Corporation. Cleared Dec 2018. https://www.510kdatabase.net/k182552/ 2018-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k182552-statstrip-xpress-glucose-hospital-fda-510k.jpg K182552 - StatStrip Xpress Glucose Hospital Meter System K182552 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Nova Biomedical Corporation. Cleared Dec 2018. https://www.510kdatabase.net/k183145/ 2018-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k183145-illuminoss-photodynamic-bone-fda-510k.jpg K183145 - IlluminOss Photodynamic Bone Stabilization System K183145 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Illuminoss Medical, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k183265/ 2018-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k183265-selectra-catheters-selectra-accessory-fda-510k.jpg K183265 - Selectra Catheters, Selectra Accessory Kit K183265 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biotronik, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k180578/ 2018-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k180578-harvest-dental-polymer-blocks-fda-510k.jpg K180578 - Harvest Dental Polymer Blocks K180578 is a FDA 510(k) cleared dental medical device. Manufacturer: Harvest Dental Products, LLC. Cleared Dec 2018. https://www.510kdatabase.net/k181869/ 2018-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k181869-on1-universal-abutment-fda-510k.jpg K181869 - On1 Universal Abutment K181869 is a FDA 510(k) cleared dental medical device. Manufacturer: Nobel Biocare AB. Cleared Dec 2018. https://www.510kdatabase.net/k182339/ 2018-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k182339-leucadia-autolok-pedicle-screw-system-fda-510k.jpg K182339 - LEUCADIA AUTOLOK™ Pedicle Screw System K182339 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Clearview Orthopedic Development, LLC. Cleared Dec 2018. https://www.510kdatabase.net/k182473/ 2018-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k182473-pyrenees-cervical-plate-system-blue-fda-510k.jpg K182473 - PYRENEES Cervical Plate System, BLUE RIDGE Cervical Plate System, OZARK Cervical Plate System, CAYMAN Thoracolumbar and Buttress Plate Systems K182473 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: K2m, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k182812/ 2018-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k182812-medline-cautery-electrode-silicone-fda-510k.jpg K182812 - Medline Cautery Electrode (SILICONE) K182812 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medline Industries, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k182954/ 2018-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k182954-salvo-spine-system-fda-510k.jpg K182954 - Salvo™ Spine System K182954 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spine Wave, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k182997/ 2018-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k182997-enlighten-iii-laser-system-fda-510k.jpg K182997 - enlighten III Laser System K182997 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cutera, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k183128/ 2018-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k183128-ensite-velocity-cardiac-mapping-system-fda-510k.jpg K183128 - EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 K183128 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott. Cleared Dec 2018. https://www.510kdatabase.net/k183383/ 2018-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k183383-anax-oct-spinal-system-fda-510k.jpg K183383 - ANAX™ OCT Spinal System K183383 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: U&I Corporation. Cleared Dec 2018. https://www.510kdatabase.net/den170055/ 2018-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/den170055-retrograde-intubation-set-fda-510k.jpg DEN170055 - Retrograde Intubation Set DEN170055 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Cook Incorporated. Cleared Dec 2018. https://www.510kdatabase.net/k180999/ 2018-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k180999-mygen-v-1000-rf-system-fda-510k.jpg K180999 - Mygen V-1000 RF System K180999 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: RF Medical Co., Ltd.. Cleared Dec 2018. https://www.510kdatabase.net/k181174/ 2018-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k181174-cardinal-health-sterilization-wrap-fda-510k.jpg K181174 - Cardinal Health Sterilization Wrap K181174 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cardinal Health200, LLC. Cleared Dec 2018. https://www.510kdatabase.net/k181625/ 2018-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k181625-life-spine-resolute-threaded-cage-system-fda-510k.jpg K181625 - Life Spine Resolute™ Threaded Cage System K181625 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k181744/ 2018-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k181744-bi-mentum-dual-mobility-system-fda-510k.jpg K181744 - BI-MENTUM dual mobility system K181744 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Serf. Cleared Dec 2018. https://www.510kdatabase.net/k181920/ 2018-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k181920-clariti-1-day-somofilcon-a-soft-fda-510k.jpg K181920 - Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker K181920 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: CooperVision, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k182902/ 2018-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k182902-precision1-fda-510k.jpg K182902 - Precision1 K182902 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Alcon Laboratories, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k182946/ 2018-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k182946-invacare-tdx-sp2-hd-with-captains-seat-fda-510k.jpg K182946 - Invacare TDX SP2-HD with Captain's Seat K182946 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Invacare Corporation. Cleared Dec 2018. https://www.510kdatabase.net/k183107/ 2018-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k183107-intuitive-surgical-vessel-sealer-extend-fda-510k.jpg K183107 - Intuitive Surgical Vessel Sealer Extend K183107 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k183168/ 2018-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k183168-openloc-l-spinal-fixation-system-fda-510k.jpg K183168 - OpenLoc-L Spinal Fixation System K183168 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: L & K Biomed Co., Ltd.. Cleared Dec 2018. https://www.510kdatabase.net/k183307/ 2018-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k183307-magma-spark-pro-magma-spark-plus-alpha-fda-510k.jpg K183307 - Magma Spark Pro (Magma Spark Plus, Alpha) K183307 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Formatk Systems , Ltd.. Cleared Dec 2018. https://www.510kdatabase.net/k173681/ 2018-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k173681-reset-o-fda-510k.jpg K173681 - reSET-O K173681 is a FDA 510(k) cleared neurology medical device. Manufacturer: Pear Therapeutics, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k180533/ 2018-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k180533-procellera-composite-antibacterial-fda-510k.jpg K180533 - Procellera Composite Antibacterial Wound Dressing K180533 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Vomaris Wound Care, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k180831/ 2018-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k180831-catsmart-fda-510k.jpg K180831 - CATSmart K180831 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Fresenius Kabi AG. Cleared Dec 2018. https://www.510kdatabase.net/k180945/ 2018-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k180945-lutronic-genius-radiofrequency-system-fda-510k.jpg K180945 - LUTRONIC GENIUS Radiofrequency System K180945 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lutronic Corporation. Cleared Dec 2018. https://www.510kdatabase.net/k181405/ 2018-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k181405-hailie-sensor-fda-510k.jpg K181405 - Hailie Sensor K181405 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Adherium (Nz), Ltd.. Cleared Dec 2018. https://www.510kdatabase.net/k181498/ 2018-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k181498-x-ray-imaging-system-for-the-mclaren-fda-510k.jpg K181498 - X-ray Imaging System for the McLaren Proton Treatment System K181498 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ehmetdx, LLC. Cleared Dec 2018. https://www.510kdatabase.net/k181675/ 2018-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k181675-fora-md6-uric-acid-monitoring-system-fda-510k.jpg K181675 - FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring System K181675 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Taidoc Technology Corporation. Cleared Dec 2018. https://www.510kdatabase.net/k181766/ 2018-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k181766-vitek-2-ast-gram-positive-inducible-fda-510k.jpg K181766 - VITEK 2 AST-Gram Positive Inducible Clindamycin Resistance K181766 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k181826/ 2018-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k181826-glenoid-polyaxial-non-locking-screws-fda-510k.jpg K181826 - Glenoid Polyaxial Non-locking Screws K181826 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Dec 2018. https://www.510kdatabase.net/k181967/ 2018-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k181967-disposable-temperature-probe-fda-510k.jpg K181967 - Disposable Temperature Probe K181967 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen Launch Electrical Co., Ltd.. Cleared Dec 2018. https://www.510kdatabase.net/k182038/ 2018-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k182038-uriscan-10acr-urine-strips-on-the-fda-510k.jpg K182038 - URiSCAN 10ACR urine strips on the URiSCAN Optima urine analyzer K182038 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Yd Diagnostics Corporation. Cleared Dec 2018. https://www.510kdatabase.net/k182075/ 2018-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k182075-benevision-n-series-patient-monitors-fda-510k.jpg K182075 - BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1) K182075 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Dec 2018. https://www.510kdatabase.net/k182280/ 2018-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k182280-ark-tramadol-assay-fda-510k.jpg K182280 - ARK Tramadol Assay K182280 is a FDA 510(k) cleared toxicology medical device. Manufacturer: ARK Diagnostics, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k182491/ 2018-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k182491-applanation-tonometer-at-2-fda-510k.jpg K182491 - Applanation tonometer AT-2 K182491 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Takagi Seiko Co., Ltd.. Cleared Dec 2018. https://www.510kdatabase.net/k182506/ 2018-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k182506-lipiscan-dynamic-meibomian-imager-fda-510k.jpg K182506 - LipiScan Dynamic Meibomian Imager K182506 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Tearscience, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k182512/ 2018-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k182512-route-92-medical-delivery-catheter-fda-510k.jpg K182512 - Route 92 Medical Delivery Catheter K182512 is a FDA 510(k) cleared neurology medical device. Manufacturer: Route 92 Medical, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k182584/ 2018-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k182584-lucent-xp-fda-510k.jpg K182584 - Lucent® XP K182584 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinal Elements, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k182724/ 2018-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k182724-celeritytm-10-steam-chemical-indicator-fda-510k.jpg K182724 - CelerityTM 10 STEAM Chemical Indicator K182724 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Dec 2018. https://www.510kdatabase.net/k182810/ 2018-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k182810-distal-radius-plating-system-fda-510k.jpg K182810 - Distal Radius Plating System K182810 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Miami Device Solutions, LLC. Cleared Dec 2018. https://www.510kdatabase.net/k182831/ 2018-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k182831-sabreline-and-sabreguard-laser-fibers-fda-510k.jpg K182831 - SabreLine and SabreGuard Laser Fibers K182831 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Coloplast Corp.. Cleared Dec 2018. https://www.510kdatabase.net/k183080/ 2018-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k183080-mega-plus-spine-system-fda-510k.jpg K183080 - Mega Plus Spine System K183080 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Bk Meditech, Co., Ltd.. Cleared Dec 2018. https://www.510kdatabase.net/k172897/ 2018-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k172897-neck-care-therapy-model-syk-509b-fda-510k.jpg K172897 - Neck Care Therapy, Model: SYK 509B K172897 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Osto Technology Co., Ltd.. Cleared Dec 2018. https://www.510kdatabase.net/k180175/ 2018-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k180175-signalmark-lung-biopsy-site-marker-fda-510k.jpg K180175 - SignalMark Lung Biopsy Site Marker K180175 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: View Point Medical, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k180657/ 2018-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k180657-resin-for-temporary-crown-bridge-fda-510k.jpg K180657 - Resin for Temporary Crown & Bridge K180657 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentis Co., Ltd.. Cleared Dec 2018. https://www.510kdatabase.net/k180670/ 2018-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k180670-iconn-campbell-interference-screw-fda-510k.jpg K180670 - ICONN Campbell Interference Screw K180670 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Iconn Orthopedics, LLC. Cleared Dec 2018. https://www.510kdatabase.net/k180679/ 2018-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k180679-citricon-liquid-and-powder-acid-fda-510k.jpg K180679 - CitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid), AcetiCon Liquid and Powder (Acid Concentrate acidified with Acetic Acid or Na Di Acetate), BicarboCon Liquid and Powder (Bicarb Concentrate), RenaCon Liquid and Powder (Acetate Concentrate with Na Acetate) K180679 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Global Scientific Technologies, LLC. Cleared Dec 2018. https://www.510kdatabase.net/k180754/ 2018-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k180754-c-zero-pedicle-screw-system-freedom-fda-510k.jpg K180754 - C-Zero Pedicle Screw System, Freedom Pedicle Screw System K180754 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Signature Orthopaedics Pty, Ltd.. Cleared Dec 2018. https://www.510kdatabase.net/k180889/ 2018-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k180889-tractus-crossing-support-catheter-fda-510k.jpg K180889 - Tractus Crossing Support Catheter K180889 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Tractus Vascular, LLC. Cleared Dec 2018. https://www.510kdatabase.net/k181583/ 2018-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k181583-adult-single-use-resuscitator-bag-fda-510k.jpg K181583 - Adult Single Use Resuscitator Bag without Pressure Relief, Adult Single Use Resuscitator Bag + Pressure Relief 40CMH20, Adult Single Use Resuscitator Bag + Pressure Relief 60CMH20, Pediatric Single Use Resuscitator Bag + Pressure Relief 40CMH20, Infant Single Use Resuscitator Bag + Pressure Relief 40CMH20 K181583 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Flexicare Medical Limited.. Cleared Dec 2018. https://www.510kdatabase.net/k181695/ 2018-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k181695-nihon-kohden-nkv-550-series-ventilator-fda-510k.jpg K181695 - Nihon Kohden NKV-550 Series Ventilator System K181695 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Nihon Kohden Orangemed, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k182007/ 2018-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k182007-renovis-tesera-ctesera-sc-anterior-fda-510k.jpg K182007 - Renovis Tesera C/Tesera SC Anterior Cervical Fusion (ACF) System K182007 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Renovis Surgical Technologies. Cleared Dec 2018. https://www.510kdatabase.net/k182048/ 2018-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k182048-avenir-complete-hip-system-fda-510k.jpg K182048 - Avenir Complete Hip System K182048 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k182183/ 2018-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k182183-gc70-gu60a-gu60a-65-gf50-gr50a-fda-510k.jpg K182183 - GC70, GU60A, GU60A-65, GF50, GR50A K182183 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Electronics Co., Ltd.. Cleared Dec 2018. https://www.510kdatabase.net/k182664/ 2018-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k182664-fixcision-fda-510k.jpg K182664 - FiXcision K182664 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Agency For Medical Innovations GmbH. Cleared Dec 2018. https://www.510kdatabase.net/k182809/ 2018-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k182809-cusa-clarity-ultrasonic-surgical-fda-510k.jpg K182809 - CUSA Clarity Ultrasonic Surgical Aspirator System K182809 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Integra LifeSciences Corporation. Cleared Dec 2018. https://www.510kdatabase.net/k183100/ 2018-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k183100-estrogen-receptor-clone-6f11-ready-to-fda-510k.jpg K183100 - Estrogen Receptor Clone 6F11 Ready-to-Use Primary Antibody for Bond, Estrogen Receptor Clone 6F11 Liquid Concentrate Primary Antibody, Novocastra K183100 is a FDA 510(k) cleared pathology medical device. Manufacturer: Leica Biosystems Newcastle, Limited. Cleared Dec 2018. https://www.510kdatabase.net/k183102/ 2018-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k183102-bond-ready-to-use-rtu-primary-antibody-fda-510k.jpg K183102 - BOND Ready-to-Use (RTU) Primary Antibody Progesterone Receptor (16) , Novocastra Concentrated Liquid Mouse Monoclonal Antibody K183102 is a FDA 510(k) cleared pathology medical device. Manufacturer: Leica Biosystems Newcastle, Limited. Cleared Dec 2018. https://www.510kdatabase.net/k183111/ 2018-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k183111-contour-24-fda-510k.jpg K183111 - Contour 24 K183111 is a FDA 510(k) cleared radiology medical device. Manufacturer: Quality Electrodynamics, LLC. Cleared Dec 2018. https://www.510kdatabase.net/k183212/ 2018-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k183212-nexus-dr-digital-x-ray-imaging-system-fda-510k.jpg K183212 - Nexus DR Digital X-ray Imaging System with stitching K183212 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varex Imaging Corporation. Cleared Dec 2018. https://www.510kdatabase.net/k183286/ 2018-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k183286-17hk701g-w-fda-510k.jpg K183286 - 17HK701G-W K183286 is a FDA 510(k) cleared radiology medical device. Manufacturer: Lg Electronics.Inc. Cleared Dec 2018. https://www.510kdatabase.net/k163601/ 2018-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k163601-rii-smart-ir-thermometer-fda-510k.jpg K163601 - RII Smart IR Thermometer K163601 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Radiant Innovation, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k173048/ 2018-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k173048-no-contact-forehead-thermometer-fda-510k.jpg K173048 - No-contact Forehead Thermometer K173048 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Dongguan Simzo Electronic Technology Co., Ltd.. Cleared Dec 2018. https://www.510kdatabase.net/k173749/ 2018-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k173749-amra-profiler-fda-510k.jpg K173749 - AMRA Profiler K173749 is a FDA 510(k) cleared radiology medical device. Manufacturer: Amra Medical AB. Cleared Dec 2018. https://www.510kdatabase.net/k181107/ 2018-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k181107-elevo-kit-snoring-intervention-device-fda-510k.jpg K181107 - Elevo® Kit Snoring Intervention Device K181107 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Zelegent, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k181231/ 2018-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k181231-depuy-synthes-t-pal-spacer-system-fda-510k.jpg K181231 - DePuy Synthes T-PAL Spacer System K181231 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Synthes Spine. Cleared Dec 2018. https://www.510kdatabase.net/k181357/ 2018-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k181357-patriot-lumbar-spacers-sustain-spacers-fda-510k.jpg K181357 - PATRIOT® Lumbar Spacers, SUSTAIN® Spacers K181357 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k181529/ 2018-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k181529-vanguard-iep-peripheral-balloon-fda-510k.jpg K181529 - Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection K181529 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Contego Medical, LLC. Cleared Dec 2018. https://www.510kdatabase.net/k181727/ 2018-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k181727-vivid-iq-fda-510k.jpg K181727 - Vivid iq K181727 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared Dec 2018. https://www.510kdatabase.net/k181958/ 2018-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k181958-magnetos-putty-fda-510k.jpg K181958 - MagnetOs Putty K181958 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Kuros Biosciences B.V. Cleared Dec 2018. https://www.510kdatabase.net/k182006/ 2018-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k182006-omni-hysteroscope-omni-hysteroscope-fda-510k.jpg K182006 - Omni Hysteroscope, Omni Hysteroscope Kits, Omni Sheaths K182006 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Hologic, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k182016/ 2018-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k182016-simplicit90y-fda-510k.jpg K182016 - Simplicit90Y K182016 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mirada Medical, Ltd.. Cleared Dec 2018. https://www.510kdatabase.net/k182035/ 2018-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k182035-ffrct-fda-510k.jpg K182035 - FFRct K182035 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: HeartFlow, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k182125/ 2018-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k182125-evolution-stemmed-cs-femur-fda-510k.jpg K182125 - EVOLUTION Stemmed CS Femur K182125 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Microport Orthopedics, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k182373/ 2018-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k182373-powerlook-tomo-detection-v2-software-fda-510k.jpg K182373 - PowerLook Tomo Detection V2 Software K182373 is a FDA 510(k) cleared radiology medical device. Manufacturer: Icad, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k182438/ 2018-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k182438-synthetic-polyisoprene-lubricated-male-fda-510k.jpg K182438 - Synthetic Polyisoprene Lubricated Male Condom - 5 senses K182438 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Sxwell USA, LLC. Cleared Dec 2018. https://www.510kdatabase.net/k182680/ 2018-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k182680-kerracontact-ag-perf-advanced-fda-510k.jpg K182680 - KerraContact Ag Perf Advanced Perforated Silver Wound Dressing K182680 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Exciton Technologies, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k182926/ 2018-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k182926-intellispace-radiology-fda-510k.jpg K182926 - IntelliSpace Radiology K182926 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Healthcare Informatics, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k183040/ 2018-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k183040-zenition-70-fda-510k.jpg K183040 - Zenition 70 K183040 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Dec 2018. https://www.510kdatabase.net/k183098/ 2018-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k183098-senhance-surgical-system-fda-510k.jpg K183098 - Senhance Surgical System K183098 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Transenterix, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k183116/ 2018-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k183116-unity-network-id-fda-510k.jpg K183116 - Unity Network ID K183116 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Healthcare. Cleared Dec 2018. https://www.510kdatabase.net/k180615/ 2018-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k180615-amicus-separator-system-amicus-fda-510k.jpg K180615 - AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter K180615 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fresenius Kabi USA,Llc. Cleared Dec 2018. https://www.510kdatabase.net/k180653/ 2018-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k180653-spartan-ecoil-system-fda-510k.jpg K180653 - Spartan eCoil System K180653 is a FDA 510(k) cleared neurology medical device. Manufacturer: Spartan Micro, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k181336/ 2018-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k181336-hs50-hs60-diagnostic-ultrasound-system-fda-510k.jpg K181336 - HS50 / HS60 Diagnostic Ultrasound System K181336 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Medison Co., Ltd.. Cleared Dec 2018. https://www.510kdatabase.net/k181825/ 2018-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k181825-caas-mr-solutions-fda-510k.jpg K181825 - CAAS MR Solutions K181825 is a FDA 510(k) cleared radiology medical device. Manufacturer: Pie Medical Imaging BV. Cleared Dec 2018. https://www.510kdatabase.net/k181935/ 2018-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k181935-endoform-reconstructive-template-non-fda-510k.jpg K181935 - Endoform Reconstructive Template - Non Absorbable K181935 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aroa Biosurgery , Ltd.. Cleared Dec 2018. https://www.510kdatabase.net/k181970/ 2018-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k181970-mectalif-posterior-extension-fda-510k.jpg K181970 - MectaLIF Posterior Extension K181970 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Dec 2018. https://www.510kdatabase.net/k182076/ 2018-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k182076-elekta-unity-fda-510k.jpg K182076 - Elekta Unity K182076 is a FDA 510(k) cleared radiology medical device. Manufacturer: Elekta Limited. Cleared Dec 2018. https://www.510kdatabase.net/k182479/ 2018-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k182479-noveos-immunoassay-analyzer-noveos-fda-510k.jpg K182479 - NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinus K182479 is a FDA 510(k) cleared immunology medical device. Manufacturer: Hycor Biomedical. Cleared Dec 2018. https://www.510kdatabase.net/k182949/ 2018-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k182949-healix-compression-screw-system-fda-510k.jpg K182949 - Healix™ Compression Screw System K182949 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nvision Biomedical Technologies, LLC. Cleared Dec 2018. https://www.510kdatabase.net/k183034/ 2018-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k183034-mosaiq-oncology-information-system-fda-510k.jpg K183034 - MOSAIQ Oncology Information System K183034 is a FDA 510(k) cleared radiology medical device. Manufacturer: Elekta, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k183037/ 2018-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k183037-monaco-rtp-system-fda-510k.jpg K183037 - Monaco RTP System K183037 is a FDA 510(k) cleared radiology medical device. Manufacturer: Elekta, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k183065/ 2018-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k183065-coolrail-linear-pen-fda-510k.jpg K183065 - Coolrail Linear Pen K183065 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: AtriCure, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k183069/ 2018-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k183069-nobelzygoma-0-fda-510k.jpg K183069 - NobelZygoma 0° K183069 is a FDA 510(k) cleared dental medical device. Manufacturer: Nobel Biocare AB. Cleared Dec 2018. https://www.510kdatabase.net/k183191/ 2018-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k183191-6420-ultrasound-system-fda-510k.jpg K183191 - 6420 Ultrasound System K183191 is a FDA 510(k) cleared radiology medical device. Manufacturer: Esaote, S.P.A.. Cleared Dec 2018. https://www.510kdatabase.net/k173083/ 2018-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k173083-implanter-dental-planning-software-fda-510k.jpg K173083 - IMPLANTER DENTAL PLANNING SOFTWARE K173083 is a FDA 510(k) cleared radiology medical device. Manufacturer: Implanter, LLC. Cleared Dec 2018. https://www.510kdatabase.net/k181159/ 2018-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k181159-lzi-fentanyl-enzyme-immunoassay-fda-510k.jpg K181159 - LZI Fentanyl Enzyme Immunoassay K181159 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Lin-Zhi International, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k181908/ 2018-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k181908-action-trackchair-fda-510k.jpg K181908 - Action Trackchair K181908 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Action Manufacturing, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k182146/ 2018-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k182146-sol-m-blood-collection-needles-sol-fda-510k.jpg K182146 - Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set K182146 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sol-Millennium Medical, Inc.. Cleared Dec 2018. https://www.510kdatabase.net/k182701/ 2018-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k182701-wondfo-t-cup-multi-drug-urine-test-cup-fda-510k.jpg K182701 - Wondfo T-Cup Multi-Drug Urine Test Cup K182701 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.. Cleared Dec 2018. https://www.510kdatabase.net/k173495/ 2018-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k173495-single-use-hot-biopsy-forceps-fd-231-fda-510k.jpg K173495 - Single Use Hot Biopsy Forceps FD-231 K173495 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Nov 2018. https://www.510kdatabase.net/k173589/ 2018-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k173589-prizma-fda-510k.jpg K173589 - Prizma K173589 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: G-Medical Innovations , Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k180298/ 2018-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k180298-wellostationx-fda-510k.jpg K180298 - welloStationX K180298 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wello, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k180388/ 2018-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k180388-transcend-365-minicpap-system-fda-510k.jpg K180388 - Transcend 365 miniCPAP System K180388 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Somnetics International, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k180482/ 2018-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k180482-zoll-propaq-m-fda-510k.jpg K180482 - ZOLL Propaq M K180482 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: ZOLL Medical Corporation. Cleared Nov 2018. https://www.510kdatabase.net/k180495/ 2018-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k180495-tinnitus-sound-generator-module-fda-510k.jpg K180495 - Tinnitus Sound Generator Module K180495 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: GN Hearing A/S. Cleared Nov 2018. https://www.510kdatabase.net/k180792/ 2018-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k180792-arterial-pressure-monitoring-settray-fda-510k.jpg K180792 - Arterial Pressure Monitoring Set/Tray K180792 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Nov 2018. https://www.510kdatabase.net/k180840/ 2018-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k180840-uno-negative-pressure-wound-therapy-fda-510k.jpg K180840 - UNO Negative Pressure Wound Therapy System K180840 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Genadyne Biotechnologies, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k180918/ 2018-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k180918-planmed-verity-fda-510k.jpg K180918 - Planmed Verity K180918 is a FDA 510(k) cleared radiology medical device. Manufacturer: Planmed OY. Cleared Nov 2018. https://www.510kdatabase.net/k181221/ 2018-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k181221-bd-phaseal-optima-closed-system-fda-510k.jpg K181221 - BD PhaSeal Optima Closed System Transfer Device K181221 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson and Company. Cleared Nov 2018. https://www.510kdatabase.net/k181286/ 2018-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k181286-ambu-ascope-rls-slim-fda-510k.jpg K181286 - Ambu aScope RLS Slim K181286 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Ambu A/S. Cleared Nov 2018. https://www.510kdatabase.net/k181524/ 2018-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k181524-vyntus-one-with-cart-vyntus-one-pft-fda-510k.jpg K181524 - Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART K181524 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Vyaire Medical, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k181588/ 2018-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k181588-pops-one-blood-glucose-monitoring-system-fda-510k.jpg K181588 - POPS! one Blood Glucose Monitoring System K181588 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Taidoc Technology Corporation. Cleared Nov 2018. https://www.510kdatabase.net/k181696/ 2018-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k181696-chitozolve-fda-510k.jpg K181696 - ChitoZolve K181696 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Gyrus Acmi, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k181784/ 2018-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k181784-spectra-s3-plus-fda-510k.jpg K181784 - Spectra S3 Plus K181784 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Uzinmedicare Co.. Cleared Nov 2018. https://www.510kdatabase.net/k182046/ 2018-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k182046-tyson-bio-hs100-blood-glucose-fda-510k.jpg K182046 - Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose Monitoring System K182046 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Tyson Bioresearch, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k182218/ 2018-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k182218-ferrismart-analysis-system-fda-510k.jpg K182218 - FerriSmart Analysis System K182218 is a FDA 510(k) cleared radiology medical device. Manufacturer: Resonance Health Analysis Services Pty, Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k182245/ 2018-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k182245-ev1000-clinical-platform-non-invasive-fda-510k.jpg K182245 - EV1000 Clinical Platform Non-Invasive (NI) with ClearSight Finger Cuffs or ClearSight System K182245 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Nov 2018. https://www.510kdatabase.net/k182249/ 2018-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k182249-ultra-samfilcon-a-multifocal-for-fda-510k.jpg K182249 - Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens K182249 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Bausch & Lomb, Incorporated. Cleared Nov 2018. https://www.510kdatabase.net/k182336/ 2018-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k182336-subtlepet-fda-510k.jpg K182336 - SubtlePET K182336 is a FDA 510(k) cleared radiology medical device. Manufacturer: Subtle Medical, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k182391/ 2018-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k182391-asi-automated-asi-rpr-test-for-fda-510k.jpg K182391 - ASI Automated ASI RPR Test for Syphilis on the ASI Evolution K182391 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Arlington Scientific, Inc. (Asi). Cleared Nov 2018. https://www.510kdatabase.net/k182498/ 2018-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k182498-advanced-skin-renewing-device-fda-510k.jpg K182498 - Advanced Skin Renewing Device K182498 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Jiangsu Unimed Laser Technology Co., Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k182600/ 2018-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k182600-powder-free-nitrile-examination-glove-fda-510k.jpg K182600 - Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) K182600 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Better Care Plastic Technology Co., Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k182663/ 2018-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k182663-nobleen-long-pulsed-alexandrite-nd-yag-fda-510k.jpg K182663 - Nobleen Long Pulsed Alexandrite & Nd: YAG Laser System K182663 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Finemec Co., Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k182797/ 2018-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k182797-sensititre-18-24-hour-mic-or-fda-510k.jpg K182797 - Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Eravacycline in the dilution range of 0.008- 16 µg/mL K182797 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Thermo Fisher Scientific. Cleared Nov 2018. https://www.510kdatabase.net/k182815/ 2018-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k182815-xvweb-3d-fda-510k.jpg K182815 - XVWeb 3D K182815 is a FDA 510(k) cleared radiology medical device. Manufacturer: Apteryx, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k183023/ 2018-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k183023-xtag-gastrointestinal-pathogen-panel-fda-510k.jpg K183023 - xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) K183023 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Luminex Molecular Diagnostics, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k183030/ 2018-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k183030-xtag-gastrointestinal-pathogen-panel-fda-510k.jpg K183030 - xTAG Gastrointestinal Pathogen Panel (GPP), xTAG Data Analysis Software (TDAS GPP) K183030 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Luminex Molecular Diagnostics, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/den180040/ 2018-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/den180040-alethia-cmv-dna-amplification-assay-fda-510k.jpg DEN180040 - Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit DEN180040 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Meridian Bioscience, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k173701/ 2018-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k173701-implant-one-system-fda-510k.jpg K173701 - Implant-One System K173701 is a FDA 510(k) cleared dental medical device. Manufacturer: Implant Logistics, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k180685/ 2018-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k180685-as-3xx-series-fingertip-pulse-oximeter-fda-510k.jpg K180685 - AS-3XX Series Fingertip Pulse Oximeter K180685 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Xiamen Acurio Instruments Co., Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k181427/ 2018-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k181427-bd-max-enteric-viral-panel-bd-max-fda-510k.jpg K181427 - BD MAX Enteric Viral Panel, BD MAX Instrument K181427 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson and Company. Cleared Nov 2018. https://www.510kdatabase.net/k181667/ 2018-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k181667-thoraguard-system-fda-510k.jpg K181667 - Thoraguard System K181667 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Centese, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k181816/ 2018-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k181816-ceramic-denture-zirconia-ceramics-block-fda-510k.jpg K181816 - Ceramic Denture Zirconia Ceramics Block K181816 is a FDA 510(k) cleared dental medical device. Manufacturer: Qinhuangdao Silide Ceramic Technology Co., Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k181880/ 2018-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k181880-vivasight-sl-tvt-system-fda-510k.jpg K181880 - VivaSight-SL (TVT) system K181880 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Etview , Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k182047/ 2018-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k182047-tyson-bio-ht100-a-blood-glucose-fda-510k.jpg K182047 - Tyson Bio HT100-A Blood Glucose Monitoring System K182047 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Tyson Bioresearch, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k182181/ 2018-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k182181-persyst-14-eeg-review-and-analysis-fda-510k.jpg K182181 - Persyst 14 EEG Review and Analysis Software K182181 is a FDA 510(k) cleared neurology medical device. Manufacturer: Persyst Development Corporation. Cleared Nov 2018. https://www.510kdatabase.net/k182418/ 2018-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k182418-v3-segmental-plating-system-fda-510k.jpg K182418 - V3 Segmental Plating System K182418 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Atlas Spine, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k182587/ 2018-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k182587-device-electrosurgical-generator-esg-150-fda-510k.jpg K182587 - Device Electrosurgical Generator ESG-150 K182587 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Olympus Winter & Ibe GmbH. Cleared Nov 2018. https://www.510kdatabase.net/k182757/ 2018-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k182757-espire-elbow-pro-espire-elbow-hybrid-fda-510k.jpg K182757 - Espire Elbow Pro, Espire Elbow Hybrid K182757 is a FDA 510(k) cleared neurology medical device. Manufacturer: College Park Industries, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k182988/ 2018-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k182988-afinion-hba1c-dx-on-afinion-2-fda-510k.jpg K182988 - Afinion HbA1c Dx on Afinion 2 K182988 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Alere Technologies AS. Cleared Nov 2018. https://www.510kdatabase.net/k180207/ 2018-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k180207-non-contact-infrared-thermometer-fda-510k.jpg K180207 - Non-contact Infrared Thermometer K180207 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Alicn Medical (Shenzhen), Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k180498/ 2018-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k180498-nuvasive-reline-fenestrated-screws-fda-510k.jpg K180498 - NuVasive Reline Fenestrated Screws, High V+ Bone Cement K180498 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Nov 2018. https://www.510kdatabase.net/k180665/ 2018-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k180665-santorini-corpectomy-cage-system-capri-fda-510k.jpg K180665 - SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System K180665 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: K2m, LLC. Cleared Nov 2018. https://www.510kdatabase.net/k181604/ 2018-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k181604-sildent-fast-light-body-sildent-fast-fda-510k.jpg K181604 - Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite K181604 is a FDA 510(k) cleared dental medical device. Manufacturer: Hrs Co., Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k181693/ 2018-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k181693-sms-femoral-stem-fda-510k.jpg K181693 - SMS Femoral Stem K181693 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Nov 2018. https://www.510kdatabase.net/k182380/ 2018-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k182380-aeon-endoscopic-stapler-fda-510k.jpg K182380 - AEON Endoscopic Stapler K182380 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lexington Medical, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k182992/ 2018-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k182992-bgm014-blood-glucose-monitoring-system-fda-510k.jpg K182992 - BGM014 Blood Glucose Monitoring System K182992 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Apex BioTechnology Corp.. Cleared Nov 2018. https://www.510kdatabase.net/k183010/ 2018-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k183010-smith-nephew-visionaire-patient-fda-510k.jpg K183010 - Smith & Nephew VISIONAIRE Patient Matched Cutting Blocks K183010 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k182169/ 2018-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k182169-advance-xp-male-sling-fda-510k.jpg K182169 - AdVance XP Male Sling K182169 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Nov 2018. https://www.510kdatabase.net/k182353/ 2018-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k182353-elia-cenp-immunoassay-elia-u1rnp-fda-510k.jpg K182353 - EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 Immunoassay K182353 is a FDA 510(k) cleared immunology medical device. Manufacturer: Phadia AB. Cleared Nov 2018. https://www.510kdatabase.net/k182369/ 2018-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k182369-gammacore-sapphire-fda-510k.jpg K182369 - gammaCore Sapphire K182369 is a FDA 510(k) cleared neurology medical device. Manufacturer: Electrocore, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k182746/ 2018-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k182746-atec-alif-and-llif-spacer-system-fda-510k.jpg K182746 - ATEC ALIF and LLIF Spacer System K182746 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k182764/ 2018-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k182764-biop-digital-colposcope-fda-510k.jpg K182764 - Biop Digital Colposcope K182764 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Biop Medical , Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k182801/ 2018-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k182801-codman-electrosurgical-irrigator-fda-510k.jpg K182801 - Codman Electrosurgical Irrigator, Codman Electrosurgical Irrigator Interconnecting Cable K182801 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Integra LifeSciences Corporation. Cleared Nov 2018. https://www.510kdatabase.net/k182983/ 2018-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k182983-ifuse-implant-system-fda-510k.jpg K182983 - iFuse Implant System® K182983 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SI-BONE, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k172837/ 2018-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k172837-low-frequency-multi-function-fda-510k.jpg K172837 - Low-frequency Multi-function physiotherapy instrument K172837 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Osto Technology Co., Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k181112/ 2018-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k181112-orchestrate-3d-fda-510k.jpg K181112 - Orchestrate 3D K181112 is a FDA 510(k) cleared dental medical device. Manufacturer: Orchestrate 3D. Cleared Nov 2018. https://www.510kdatabase.net/k182134/ 2018-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k182134-arix-rad-radiographic-system-fda-510k.jpg K182134 - ARiX RAD Radiographic System K182134 is a FDA 510(k) cleared radiology medical device. Manufacturer: Compania Mexicana DE Radiologia Cgr, S.A. DE C.V.. Cleared Nov 2018. https://www.510kdatabase.net/k182324/ 2018-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k182324-ekosonic-endovascular-system-fda-510k.jpg K182324 - EkoSonic Endovascular System K182324 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Btg International, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k182346/ 2018-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k182346-truliant-porous-tibial-tray-and-fda-510k.jpg K182346 - TRULIANT Porous Tibial Tray and Exactech Alteon Bone Screws K182346 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k182431/ 2018-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k182431-konicaminolta-di-x1-fda-510k.jpg K182431 - Konicaminolta DI-X1 K182431 is a FDA 510(k) cleared radiology medical device. Manufacturer: Konica Minolta, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k182470/ 2018-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k182470-plateau-spacer-system-fda-510k.jpg K182470 - Plateau Spacer System K182470 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine. Cleared Nov 2018. https://www.510kdatabase.net/k182699/ 2018-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k182699-selethru-ptca-balloon-dilatation-fda-510k.jpg K182699 - Selethru PTCA Balloon Dilatation Catheter K182699 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Kossel Medtech (Suzhou) Co., Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k183009/ 2018-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k183009-hemostatix-model-p8400-disposable-fda-510k.jpg K183009 - HEMOSTATIX MODEL P8400 DISPOSABLE HANDLE, HEMOSTATIX MODEL P8400 DISPOSABLE BLADES K183009 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Hemostatix Medical Technologies, LLC. Cleared Nov 2018. https://www.510kdatabase.net/k183013/ 2018-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k183013-vitrea-software-package-vstp-001a-fda-510k.jpg K183013 - Vitrea Software Package, VSTP-001A K183013 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Nov 2018. https://www.510kdatabase.net/k183038/ 2018-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k183038-corin-optimized-positioning-system-ops-fda-510k.jpg K183038 - Corin Optimized Positioning System (OPS) Plan K183038 is a FDA 510(k) cleared radiology medical device. Manufacturer: Corin USA. Cleared Nov 2018. https://www.510kdatabase.net/k183159/ 2018-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k183159-3m-clarity-aligners-fda-510k.jpg K183159 - 3M Clarity Aligners K183159 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Nov 2018. https://www.510kdatabase.net/k183174/ 2018-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k183174-flexcath-advance-steerable-sheath-and-fda-510k.jpg K183174 - FlexCath Advance Steerable Sheath and Dilator K183174 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Cryocath, LP. Cleared Nov 2018. https://www.510kdatabase.net/k180430/ 2018-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k180430-digistat-smart-central-fda-510k.jpg K180430 - Digistat Smart Central K180430 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ascom Ums Srl Unipersonale. Cleared Nov 2018. https://www.510kdatabase.net/k180557/ 2018-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k180557-greene-renal-transplant-stent-set-fda-510k.jpg K180557 - Greene Renal Transplant Stent Set K180557 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Nov 2018. https://www.510kdatabase.net/k180573/ 2018-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k180573-responsive-arthroscopy-interference-fda-510k.jpg K180573 - Responsive Arthroscopy Interference Screw System K180573 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Responsive Arthroscopy, LLC. Cleared Nov 2018. https://www.510kdatabase.net/k180607/ 2018-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k180607-steroid-21-hydroxylase-antibody-21-fda-510k.jpg K180607 - Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit K180607 is a FDA 510(k) cleared immunology medical device. Manufacturer: Kronus, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k180643/ 2018-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k180643-medcu-antibacterial-wound-dressings-fda-510k.jpg K180643 - MedCu Antibacterial Wound Dressings with Copper-Oxide (MedCu ABWDs) K180643 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medcu Technologies , Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k181381/ 2018-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k181381-ab-dental-devices-dental-implants-system-fda-510k.jpg K181381 - A.B. Dental Devices Dental Implants System K181381 is a FDA 510(k) cleared dental medical device. Manufacturer: A.B. Dental Device , Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k181443/ 2018-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k181443-accula-rsv-test-fda-510k.jpg K181443 - Accula RSV Test K181443 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Mesa Biotech, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k182304/ 2018-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k182304-hyper-gp-tisilfocon-a-daily-wear-fda-510k.jpg K182304 - Hyper GP (tisilfocon A) Daily Wear Contact Lens K182304 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Contamac, Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k182684/ 2018-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k182684-hammertechtm-fixation-system-fda-510k.jpg K182684 - HammerTechTM Fixation System K182684 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Fusion Orthopedics, LLC. Cleared Nov 2018. https://www.510kdatabase.net/k182687/ 2018-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k182687-motion-tracking-and-compensation-fda-510k.jpg K182687 - Motion Tracking and Compensation Feature for the Radixact Treatment Delivery System K182687 is a FDA 510(k) cleared radiology medical device. Manufacturer: Accuray Incorporated. Cleared Nov 2018. https://www.510kdatabase.net/k182967/ 2018-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k182967-visor-system-fda-510k.jpg K182967 - Visor System K182967 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cerebrotech Medical Systems, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k182306/ 2018-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k182306-sunkingdom-slit-lamp-fda-510k.jpg K182306 - Sunkingdom Slit Lamp K182306 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Chongqing Sunkingdom Medical Instrument Co., Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k173744/ 2018-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k173744-profuse-cad-fda-510k.jpg K173744 - ProFuse CAD K173744 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eigen. Cleared Nov 2018. https://www.510kdatabase.net/k180541/ 2018-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k180541-depuy-synthes-20-mm-quick-insertion-fda-510k.jpg K180541 - DePuy Synthes 2.0 mm Quick Insertion Screws K180541 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes USA Products, LLC. Cleared Nov 2018. https://www.510kdatabase.net/k180546/ 2018-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k180546-jet-power-injectable-picc-fda-510k.jpg K180546 - Jet Power Injectable PICC K180546 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jet Medical, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k181123/ 2018-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k181123-apnodent-appliance-fda-510k.jpg K181123 - ApnoDent Appliance K181123 is a FDA 510(k) cleared dental medical device. Manufacturer: Apnomed, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k181297/ 2018-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k181297-dentioiii-series-dentioiii-dentioiii-s-fda-510k.jpg K181297 - DENTIOIII series (DENTIOIII, DENTIOIII-S) K181297 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hdx Will Corp.. Cleared Nov 2018. https://www.510kdatabase.net/k181454/ 2018-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k181454-dailies-aquacomfort-plus-dailies-fda-510k.jpg K181454 - DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES AquaComfort Plus Toric and DAILIES AquaComfort Plus Multifocal K181454 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Alcon Laboratories, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k181704/ 2018-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k181704-transpara-fda-510k.jpg K181704 - Transpara K181704 is a FDA 510(k) cleared radiology medical device. Manufacturer: Screenpoint Medical B.V.. Cleared Nov 2018. https://www.510kdatabase.net/k181996/ 2018-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k181996-matrx-plus-fda-510k.jpg K181996 - MATRx Plus K181996 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Zephyr Sleep Technologies. Cleared Nov 2018. https://www.510kdatabase.net/k182027/ 2018-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k182027-wet-organics-personal-lubricant-fda-510k.jpg K182027 - Wet Organics Personal Lubricant K182027 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Trigg Laboratories Dba Wet International. Cleared Nov 2018. https://www.510kdatabase.net/k182277/ 2018-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k182277-versana-premier-fda-510k.jpg K182277 - Versana Premier K182277 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared Nov 2018. https://www.510kdatabase.net/k182352/ 2018-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k182352-sp-link-system-fda-510k.jpg K182352 - SP-LINK™ System K182352 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medical Designs, LLC. Cleared Nov 2018. https://www.510kdatabase.net/k182581/ 2018-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k182581-playmakar-sport-muscle-stimulator-fda-510k.jpg K182581 - PlayMakar Sport Muscle Stimulator, Model PRO-500 K182581 is a FDA 510(k) cleared neurology medical device. Manufacturer: Playmakar, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k182606/ 2018-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k182606-pinpoint-endoscopic-fluorescence-fda-510k.jpg K182606 - PINPOINT Endoscopic Fluorescence Imaging System K182606 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Novadaq Technologies Ulc. (Now A Part of Stryker). Cleared Nov 2018. https://www.510kdatabase.net/k182779/ 2018-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k182779-ark-eddp-assay-fda-510k.jpg K182779 - ARK EDDP Assay K182779 is a FDA 510(k) cleared toxicology medical device. Manufacturer: ARK Diagnostics, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k182909/ 2018-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k182909-roth-net-retriever-product-line-fda-510k.jpg K182909 - Roth Net Retriever Product Line K182909 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: United States Endoscopy Group, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k182957/ 2018-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k182957-heli-fx-endoanchor-system-fda-510k.jpg K182957 - Heli-FX EndoAnchor System K182957 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k182977/ 2018-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k182977-isolette-8000-plus-fda-510k.jpg K182977 - Isolette 8000 Plus K182977 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Draeger Medical Systems, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k180550/ 2018-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k180550-nuvasive-monolith-cervical-corpectomy-fda-510k.jpg K180550 - NuVasive Monolith Cervical Corpectomy System K180550 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Nov 2018. https://www.510kdatabase.net/k180917/ 2018-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k180917-gc-acrylic-primer-fda-510k.jpg K180917 - GC Acrylic Primer K180917 is a FDA 510(k) cleared dental medical device. Manufacturer: GC America, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k181247/ 2018-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k181247-vitrea-ct-brain-perfusion-fda-510k.jpg K181247 - Vitrea CT Brain Perfusion K181247 is a FDA 510(k) cleared radiology medical device. Manufacturer: Vital Images, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k181731/ 2018-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k181731-mr-compatible-aspiration-kit-fda-510k.jpg K181731 - MR Compatible Aspiration Kit K181731 is a FDA 510(k) cleared neurology medical device. Manufacturer: Mri Interventions, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k181806/ 2018-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k181806-arix-sternal-system-fda-510k.jpg K181806 - ARIX Sternal System K181806 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Jeil Medical Corporation. Cleared Nov 2018. https://www.510kdatabase.net/k181857/ 2018-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k181857-powder-free-nitrile-patient-fda-510k.jpg K181857 - Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate K181857 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Kossan International Sdn Bhd. Cleared Nov 2018. https://www.510kdatabase.net/k182133/ 2018-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k182133-infrared-thermometer-fda-510k.jpg K182133 - Infrared Thermometer K182133 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen AOJ Medical Technology Co., Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k182265/ 2018-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k182265-codman-certas-plus-programmable-valve-fda-510k.jpg K182265 - CodMan Certas Plus Programmable Valve K182265 is a FDA 510(k) cleared neurology medical device. Manufacturer: Integra Lifesciences Corp.. Cleared Nov 2018. https://www.510kdatabase.net/k182274/ 2018-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k182274-orbit-subretinal-delivery-system-fda-510k.jpg K182274 - Orbit Subretinal Delivery System K182274 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Orbit Biomedical, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k182288/ 2018-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k182288-tph-spectra-st-flowable-composite-fda-510k.jpg K182288 - TPH Spectra ST Flowable Composite Restorative K182288 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona. Cleared Nov 2018. https://www.510kdatabase.net/k182291/ 2018-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k182291-6mp-color-lcd-monitor-c61w-fda-510k.jpg K182291 - 6MP Color LCD Monitor (C61W+) K182291 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Beacon Display Technology Co., Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k182652/ 2018-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k182652-cocet-digital-thermometer-models-kft-fda-510k.jpg K182652 - COCET Digital Thermometer (Models KFT-01/KFT-02/KFT-03/KFT-04/KFT-05/KFT-06/KFT-07/KFT-08/KFT-09/KFT-10 K182652 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Kangfu Medical Equipment Factory. Cleared Nov 2018. https://www.510kdatabase.net/k182696/ 2018-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k182696-telepack-x-led-fda-510k.jpg K182696 - Telepack X LED K182696 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k182715/ 2018-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k182715-piloter-exppiloterpiloter-p-diagnostic-fda-510k.jpg K182715 - Piloter Exp/Piloter/Piloter P Diagnostic Ultrasound System K182715 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Wisonic Medical Technology Co. , Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k182931/ 2018-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k182931-verify-all-in-one-steam-reusable-test-fda-510k.jpg K182931 - VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag K182931 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Steris Corporations. Cleared Nov 2018. https://www.510kdatabase.net/k180432/ 2018-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k180432-ai-ecg-platform-fda-510k.jpg K180432 - AI-ECG Platform K180432 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Carewell Electronics., Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k182535/ 2018-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k182535-r3-anteverted-liners-fda-510k.jpg K182535 - R3 Anteverted Liners K182535 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k182654/ 2018-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k182654-safecare-multi-drug-urine-test-cup-fda-510k.jpg K182654 - SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip Card K182654 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Safecare Biotech (Hangzhou) Co., Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k182772/ 2018-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k182772-valleylab-smoke-evacuation-rocker-fda-510k.jpg K182772 - Valleylab Smoke Evacuation Rocker Switch Pencil , Valleylab Telescoping Smoke Evacuation Rocker Switch Pencil K182772 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien. Cleared Nov 2018. https://www.510kdatabase.net/den180030/ 2018-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/den180030-qms-plazomicin-immunoassay-fda-510k.jpg DEN180030 - QMS Plazomicin Immunoassay DEN180030 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Microgenics Corporation. Cleared Nov 2018. https://www.510kdatabase.net/k173373/ 2018-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k173373-safet-t-piece-resuscitator-fda-510k.jpg K173373 - SafeT T-Piece Resuscitator K173373 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Ventlab, LLC. Cleared Nov 2018. https://www.510kdatabase.net/k180184/ 2018-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k180184-zeramexr-xt-dental-implant-system-fda-510k.jpg K180184 - Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System K180184 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentalpoint AG. Cleared Nov 2018. https://www.510kdatabase.net/k180343/ 2018-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k180343-lenshooke-x1-pro-semen-quality-fda-510k.jpg K180343 - LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer K180343 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bonraybio Co., Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k180528/ 2018-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k180528-instrusafer-sterilization-container-fda-510k.jpg K180528 - InstruSafe(R) Sterilization Container K180528 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Summit Medical, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k180645/ 2018-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k180645-powder-free-examination-gloves-with-fda-510k.jpg K180645 - Powder Free Examination Gloves with Colloidal Oatmeal USP and Tested for Use with Chemotherapy Drugs - (Lemon Green) K180645 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hartalega Sdn Bhd. Cleared Nov 2018. https://www.510kdatabase.net/k180881/ 2018-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k180881-hemosphere-advanced-monitor-hemosphere-fda-510k.jpg K180881 - HemoSphere Advanced Monitor, HemoSphere Pressure Cable K180881 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Nov 2018. https://www.510kdatabase.net/k180979/ 2018-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k180979-pureflex-arterial-cannulae-fda-510k.jpg K180979 - PureFlex Arterial Cannulae K180979 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sorin Group Italia S.R.L.. Cleared Nov 2018. https://www.510kdatabase.net/k181137/ 2018-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k181137-it-iii-active-system-fda-510k.jpg K181137 - IT-III active System K181137 is a FDA 510(k) cleared dental medical device. Manufacturer: Neobiotech Co., Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k181140/ 2018-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k181140-axis-chena-cervical-peek-spacer-system-fda-510k.jpg K181140 - Axis Chena Cervical PEEK Spacer System K181140 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Axis Orthopaedics. Cleared Nov 2018. https://www.510kdatabase.net/k181396/ 2018-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k181396-oral-device-oa-oral-device-s-fda-510k.jpg K181396 - Oral Device OA, Oral Device S K181396 is a FDA 510(k) cleared dental medical device. Manufacturer: Passion For Life Healthcare (Uk) Limited. Cleared Nov 2018. https://www.510kdatabase.net/k181643/ 2018-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k181643-smartbag-smartpouch-fda-510k.jpg K181643 - SmartBag (SmartPouch) K181643 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: 11 Health Technologies Limited. Cleared Nov 2018. https://www.510kdatabase.net/k181646/ 2018-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k181646-celesteion-pca-9000a3-v65-fda-510k.jpg K181646 - Celesteion, PCA-9000A/3, V6.5 K181646 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Nov 2018. https://www.510kdatabase.net/k181709/ 2018-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k181709-serenity-piezo-sensor-serenity-fda-510k.jpg K181709 - Serenity Piezo Sensor, Serenity Thermocouple Sensor K181709 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neurotronics, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k181921/ 2018-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k181921-solidity-vertebral-body-replacement-fda-510k.jpg K181921 - Solidity Vertebral Body Replacement K181921 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ulrich Medical USA. Cleared Nov 2018. https://www.510kdatabase.net/k181948/ 2018-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k181948-15t-16ch-diagnostic-breast-coil-30t-fda-510k.jpg K181948 - 1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil K181948 is a FDA 510(k) cleared radiology medical device. Manufacturer: Rapid Biomedical GmbH. Cleared Nov 2018. https://www.510kdatabase.net/k182090/ 2018-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k182090-apostherapy-system-fda-510k.jpg K182090 - AposTherapy System K182090 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Apos Medical Assets , Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k182109/ 2018-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k182109-redapt-modular-acetabular-shell-fda-510k.jpg K182109 - REDAPT Modular Acetabular Shell K182109 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k182179/ 2018-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k182179-advantagerib-anterior-system-fda-510k.jpg K182179 - AdvantageRib Anterior System K182179 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Sig Medical Corp.. Cleared Nov 2018. https://www.510kdatabase.net/k182201/ 2018-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k182201-stratum-foot-plating-system-fda-510k.jpg K182201 - Stratum™ Foot Plating System K182201 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nextremity Solutions, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k182298/ 2018-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k182298-hemochroma-plus-system-fda-510k.jpg K182298 - hemochroma PLUS System K182298 is a FDA 510(k) cleared hematology medical device. Manufacturer: Immunostics Inc.,. Cleared Nov 2018. https://www.510kdatabase.net/k182562/ 2018-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k182562-hair-boom-69-fda-510k.jpg K182562 - Hair Boom 69 K182562 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wontech. Cleared Nov 2018. https://www.510kdatabase.net/k182626/ 2018-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k182626-oec-one-fda-510k.jpg K182626 - OEC One K182626 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Hualun Medical Systems Co. , Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k182916/ 2018-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k182916-pruitt-f3-carotid-shunt-10-fr-pruitt-fda-510k.jpg K182916 - Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr K182916 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Lemaitre Vascular. Cleared Nov 2018. https://www.510kdatabase.net/k182958/ 2018-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k182958-15t-16ch-breast-coil-fda-510k.jpg K182958 - 1.5T 16ch Breast Coil K182958 is a FDA 510(k) cleared radiology medical device. Manufacturer: Neocoil, LLC. Cleared Nov 2018. https://www.510kdatabase.net/k182980/ 2018-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k182980-zilver-518-biliary-stent-zilver-635-fda-510k.jpg K182980 - Zilver 518 Biliary Stent, Zilver 635 Biliary Stent K182980 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Ireland, Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k173971/ 2018-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k173971-k2-zirkon-blank-white-classic-fda-510k.jpg K173971 - K2 Zirkon Blank white classic K173971 is a FDA 510(k) cleared dental medical device. Manufacturer: Yeti Dentalprodukte GmbH. Cleared Nov 2018. https://www.510kdatabase.net/k180650/ 2018-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k180650-amsel-endo-occluder-fda-510k.jpg K180650 - Amsel Endo Occluder K180650 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Amsel Medical Corporation. Cleared Nov 2018. https://www.510kdatabase.net/k180668/ 2018-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k180668-single-use-aspiration-needle-na-u401sx-fda-510k.jpg K180668 - Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N K180668 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Nov 2018. https://www.510kdatabase.net/k181292/ 2018-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k181292-primesight-unity-9000-video-processor-fda-510k.jpg K181292 - PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor K181292 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Cogentix Medical, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k181324/ 2018-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k181324-filmarray-pneumonia-panel-plus-fda-510k.jpg K181324 - FilmArray Pneumonia Panel plus K181324 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Biofire Diagnostics, LLC. Cleared Nov 2018. https://www.510kdatabase.net/k181689/ 2018-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k181689-nexcomp-fda-510k.jpg K181689 - Nexcomp K181689 is a FDA 510(k) cleared dental medical device. Manufacturer: Meta Biomed Co., Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k181750/ 2018-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k181750-sitzmarks-fda-510k.jpg K181750 - SITZMARKS K181750 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Konsyl Pharmaceuticals. Cleared Nov 2018. https://www.510kdatabase.net/k181831/ 2018-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k181831-intellivue-multi-measurement-module-mmx-fda-510k.jpg K181831 - IntelliVue Multi-Measurement Module MMX K181831 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Philips Medizin Systeme Boeblingen GmbH. Cleared Nov 2018. https://www.510kdatabase.net/k181897/ 2018-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k181897-reprocessed-marinr-diagnostic-ep-fda-510k.jpg K181897 - Reprocessed Marinr Diagnostic EP Catheter K181897 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Innovative Health, LLC. Cleared Nov 2018. https://www.510kdatabase.net/k181985/ 2018-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k181985-voluson-e6-voluson-e8-voluson-e10-fda-510k.jpg K181985 - Voluson E6, Voluson E8, Voluson E10 K181985 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Nov 2018. https://www.510kdatabase.net/k181998/ 2018-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k181998-cardioband-ecg-event-recorder-fda-510k.jpg K181998 - CardioBand ECG Event Recorder K181998 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Samsung Strategy and Innovation Center (Ssic). Cleared Nov 2018. https://www.510kdatabase.net/k182182/ 2018-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k182182-yukon-oct-spinal-system-fda-510k.jpg K182182 - YUKON OCT Spinal System K182182 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: K2m. Cleared Nov 2018. https://www.510kdatabase.net/k182255/ 2018-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k182255-cangaroo-neuro-envelope-small-fda-510k.jpg K182255 - CanGaroo Neuro Envelope (small) K182255 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aziyo Biologics, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k182528/ 2018-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k182528-nitrile-glove-powder-free-black-fda-510k.jpg K182528 - Nitrile Glove Powder Free Black K182528 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Haining Medical Products Co., Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k183117/ 2018-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k183117-pathloc-l-mis-spinal-system-fda-510k.jpg K183117 - PathLoc-L MIS Spinal System K183117 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: L & K Biomed Co., Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k172602/ 2018-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k172602-miracu-fda-510k.jpg K172602 - Miracu K172602 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Feeltech Co., Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k180463/ 2018-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k180463-apoller-flow-light-cure-flowable-fda-510k.jpg K180463 - Apoller Flow Light Cure Flowable Composite K180463 is a FDA 510(k) cleared dental medical device. Manufacturer: Greenway Yw, LLC. Cleared Nov 2018. https://www.510kdatabase.net/k181090/ 2018-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k181090-invacare-solara-3g-and-solara-3g-spree-fda-510k.jpg K181090 - Invacare® Solara® 3G and Solara® 3G Spree Manual Wheelchairs K181090 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Invacare Corporation. Cleared Nov 2018. https://www.510kdatabase.net/k181434/ 2018-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k181434-sporview-rapid-read-biological-fda-510k.jpg K181434 - SporView Rapid Read Biological Indicator SteamPlus Test Pack K181434 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Crosstex/Spsmedical, A Division of Cantel Medical. Cleared Nov 2018. https://www.510kdatabase.net/k181497/ 2018-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k181497-hpm-6000uf-fda-510k.jpg K181497 - HPM-6000UF K181497 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: BTL Industries, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k181829/ 2018-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k181829-velofix-tlif-cage-fda-510k.jpg K181829 - Velofix TLIF Cage K181829 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: U&I Corporation. Cleared Nov 2018. https://www.510kdatabase.net/k181850/ 2018-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k181850-inversa-implants-fda-510k.jpg K181850 - Inversa Implants K181850 is a FDA 510(k) cleared dental medical device. Manufacturer: Southern Implants (Pty), Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k181886/ 2018-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k181886-vivasight-dl-system-fda-510k.jpg K181886 - VivaSight-DL System K181886 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Etview , Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k181963/ 2018-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k181963-ostapek-interbody-fusion-cages-fda-510k.jpg K181963 - ostaPek Interbody Fusion Cages K181963 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Coligne AG. Cleared Nov 2018. https://www.510kdatabase.net/k182097/ 2018-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k182097-react-71-catheter-fda-510k.jpg K182097 - React 71 Catheter K182097 is a FDA 510(k) cleared neurology medical device. Manufacturer: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. Cleared Nov 2018. https://www.510kdatabase.net/k182101/ 2018-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k182101-riptide-aspiration-system-react-71-fda-510k.jpg K182101 - Riptide Aspiration System (React 71 Catheter) K182101 is a FDA 510(k) cleared neurology medical device. Manufacturer: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. Cleared Nov 2018. https://www.510kdatabase.net/k182105/ 2018-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k182105-jo-naturalove-personal-lubricant-jo-fda-510k.jpg K182105 - JO Naturalove Personal Lubricant, JO Naturalove Strawberry Fields Flavored Personal Lubricant K182105 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: United Consortium. Cleared Nov 2018. https://www.510kdatabase.net/k182543/ 2018-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k182543-wearable-device-fda-510k.jpg K182543 - Wearable Device K182543 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Snap40, Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k182603/ 2018-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k182603-z6-diagnostic-ultrasound-system-fda-510k.jpg K182603 - Z6 Diagnostic Ultrasound System K182603 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k182604/ 2018-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k182604-new-era-fda-510k.jpg K182604 - New Era K182604 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Step UP Skin Laser, LLC. Cleared Nov 2018. https://www.510kdatabase.net/k182653/ 2018-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k182653-voyant-maryland-fusion-device-fda-510k.jpg K182653 - Voyant Maryland Fusion Device K182653 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Applied Medical Resources Corp.. Cleared Nov 2018. https://www.510kdatabase.net/k182882/ 2018-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k182882-crystalview-pro-irrigation-console-fda-510k.jpg K182882 - CrystalView Pro Irrigation Console, CrystalView Pro Autoclavable Remote Control K182882 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Conmed Corporation. Cleared Nov 2018. https://www.510kdatabase.net/k172792/ 2018-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k172792-handheld-pulse-oximeter-model-sp-20-fda-510k.jpg K172792 - Handheld Pulse Oximeter, Model SP-20 K172792 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Creative Industry Co., Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k180478/ 2018-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k180478-rectalpro-75-endorectal-balloon-fda-510k.jpg K180478 - RectalPro 75 Endorectal Balloon K180478 is a FDA 510(k) cleared radiology medical device. Manufacturer: Qlrad International , Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k181369/ 2018-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k181369-immucise-intradermal-injection-system-fda-510k.jpg K181369 - Immucise Intradermal Injection System K181369 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terumo Corporation. Cleared Nov 2018. https://www.510kdatabase.net/k182248/ 2018-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k182248-aspire-venting-tube-fda-510k.jpg K182248 - Aspire Venting Tube K182248 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Aspire Bariatrics, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k182508/ 2018-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k182508-saxxony-posterior-cervical-thoracic-fda-510k.jpg K182508 - Saxxony™ Posterior Cervical Thoracic System K182508 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nexxt Spine, LLC. Cleared Nov 2018. https://www.510kdatabase.net/k182598/ 2018-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k182598-versalink-fixation-system-fda-510k.jpg K182598 - VersaLink™ Fixation System K182598 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Premia Spine, Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k182674/ 2018-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k182674-largan-u38-polymacon-daily-wear-soft-fda-510k.jpg K182674 - Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia K182674 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Largan Medical Co., Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k172907/ 2018-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k172907-elan-4-air-motor-system-fda-510k.jpg K172907 - ELAN 4 Air Motor System K172907 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k180395/ 2018-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k180395-ez-io-intraosseous-vascular-access-fda-510k.jpg K180395 - EZ-IO Intraosseous Vascular Access System K180395 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Arrow International, Inc. (Subsidiary of Teleflex, Inc.). Cleared Nov 2018. https://www.510kdatabase.net/k180966/ 2018-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k180966-filmarray-pneumonia-panel-fda-510k.jpg K180966 - FilmArray Pneumonia Panel K180966 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Biofire Diagnostics, LLC. Cleared Nov 2018. https://www.510kdatabase.net/k181469/ 2018-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k181469-cryotopus-flash-and-cryotopus-scoop-fda-510k.jpg K181469 - Cryotop®US-flash and Cryotop®US-scoop K181469 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Kitazato Corporation. Cleared Nov 2018. https://www.510kdatabase.net/k181559/ 2018-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k181559-neurosign-v4-intraoperative-nerve-fda-510k.jpg K181559 - Neurosign V4 Intraoperative Nerve Monitor K181559 is a FDA 510(k) cleared neurology medical device. Manufacturer: Magstim Company, Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k181759/ 2018-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k181759-powerdot-pd-01mt-fda-510k.jpg K181759 - PowerDot PD-01MT K181759 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Smartmissimo Technologies Pte, Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k181890/ 2018-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k181890-brainlab-compatible-k2m-navigation-fda-510k.jpg K181890 - Brainlab Compatible K2M Navigation Instruments K181890 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: K2m. Cleared Nov 2018. https://www.510kdatabase.net/k181992/ 2018-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k181992-heat-pain-pro-fda-510k.jpg K181992 - Heat Pain Pro K181992 is a FDA 510(k) cleared neurology medical device. Manufacturer: Omron Healthcare, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k182083/ 2018-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k182083-catalys-precision-laser-system-fda-510k.jpg K182083 - Catalys Precision Laser System K182083 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Amo Manufacturing USA, LLC. Cleared Nov 2018. https://www.510kdatabase.net/k182195/ 2018-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k182195-arco-sa-lumbar-cage-system-fda-510k.jpg K182195 - Arco™-SA Lumbar Cage System K182195 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Neurostructures, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k182338/ 2018-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k182338-blue-sky-bio-computerized-orthodontic-fda-510k.jpg K182338 - Blue Sky Bio Computerized Orthodontic Bracket System K182338 is a FDA 510(k) cleared dental medical device. Manufacturer: Blue Sky Bio. Cleared Nov 2018. https://www.510kdatabase.net/k182360/ 2018-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k182360-teleport-microcatheter-fda-510k.jpg K182360 - Teleport Microcatheter K182360 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Orbusneich Medical Trading, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k182481/ 2018-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k182481-hem-6410t-zm-wrist-blood-pressure-fda-510k.jpg K182481 - HEM-6410T-ZM Wrist Blood Pressure Monitor K182481 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Omron Healthcare, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k182484/ 2018-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k182484-veriton-ct-whole-body-spectct-system-fda-510k.jpg K182484 - VERITON CT whole body SPECT/CT system K182484 is a FDA 510(k) cleared radiology medical device. Manufacturer: Spectrum Dynamics Medical, Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k182530/ 2018-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k182530-bioeasy-multi-drug-test-cup-fda-510k.jpg K182530 - BIOEASY Multi-Drug Test Cup K182530 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Shenzhen Bioeasy Biotechnology Co., Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k182565/ 2018-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k182565-atricure-cryoice-cryosphere-fda-510k.jpg K182565 - AtriCure cryoICE cryoSPHERE cryoablation probe K182565 is a FDA 510(k) cleared neurology medical device. Manufacturer: AtriCure, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k182649/ 2018-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k182649-enteral-feeding-syringes-with-enfit-fda-510k.jpg K182649 - Enteral Feeding Syringes with Enfit Connectors K182649 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Jiangsu Kangbao Medical Equipment Co., Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k182808/ 2018-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k182808-aspida-anterior-lumbar-plating-system-fda-510k.jpg K182808 - Aspida® Anterior Lumbar Plating System K182808 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k182857/ 2018-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k182857-epiq-diagnostic-ultrasound-system-epiq-fda-510k.jpg K182857 - EPIQ Diagnostic Ultrasound System, EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System K182857 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Ultrasound, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k173917/ 2018-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k173917-neoclose-pds-fda-510k.jpg K173917 - neoClose PDS K173917 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Neosurgical, Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k180047/ 2018-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k180047-esotest-multi-esophageal-temperature-fda-510k.jpg K180047 - ESOTEST MULTI Esophageal Temperature Probe and Temperature Monitoring System K180047 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Fiab Spa. Cleared Nov 2018. https://www.510kdatabase.net/k180631/ 2018-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k180631-silk-voice-fda-510k.jpg K180631 - Silk Voice K180631 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Sofregen Medical, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k180732/ 2018-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k180732-mirocam-capsule-endoscope-system-fda-510k.jpg K180732 - MiroCam Capsule Endoscope System K180732 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Intromedic Co., Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k180949/ 2018-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k180949-steribite-fda-510k.jpg K180949 - Steribite K180949 is a FDA 510(k) cleared neurology medical device. Manufacturer: Rjr Surgical, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k181590/ 2018-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k181590-neurostructures-cavetto-max-cervical-fda-510k.jpg K181590 - Neurostructures Cavetto® [MAX] Cervical Cage System K181590 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Neurostructures, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k181684/ 2018-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k181684-vamp-plus-venousarterial-blood-fda-510k.jpg K181684 - VAMP Plus Venous/Arterial Blood Management Protection System K181684 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Nov 2018. https://www.510kdatabase.net/k181918/ 2018-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k181918-cardioinsight-cardiac-mapping-system-fda-510k.jpg K181918 - CardioInsight Cardiac Mapping System K181918 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k182030/ 2018-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k182030-faros-mobile-fda-510k.jpg K182030 - Faros Mobile K182030 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bittium Biosignals , Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k182166/ 2018-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k182166-wrist-blood-pressure-monitor-model-fda-510k.jpg K182166 - Wrist Blood Pressure Monitor Model BP4350 K182166 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Omron Healthcare, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k182329/ 2018-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k182329-surecure-orthodontic-aligner-system-fda-510k.jpg K182329 - SureCure Orthodontic Aligner System K182329 is a FDA 510(k) cleared dental medical device. Manufacturer: Digital Orthodontic Care. Cleared Nov 2018. https://www.510kdatabase.net/k182462/ 2018-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k182462-exactech-alteon-highly-polished-fda-510k.jpg K182462 - Exactech Alteon Highly Polished Femoral Stem K182462 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k182472/ 2018-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k182472-cepheid-xpert-gbs-lb-control-panel-fda-510k.jpg K182472 - Cepheid Xpert GBS LB Control Panel K182472 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Microbiologics, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k182838/ 2018-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k182838-geistlich-derma-gide-fda-510k.jpg K182838 - Geistlich Derma-Gide K182838 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Geistlich Pharma AG. Cleared Nov 2018. https://www.510kdatabase.net/k172999/ 2018-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k172999-uws-mr-fda-510k.jpg K172999 - uWS-MR K172999 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k173001/ 2018-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k173001-uws-ct-fda-510k.jpg K173001 - uWS-CT K173001 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k180381/ 2018-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k180381-powder-free-vinyl-patient-examination-fda-510k.jpg K180381 - Powder Free Vinyl Patient Examination Gloves K180381 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shanxi Hongjin Plastic Technology Co., Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k180683/ 2018-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k180683-certa-dose-pediatric-midazolam-5mgml-fda-510k.jpg K180683 - Certa Dose Pediatric Midazolam 5mg/mL IM Syringe K180683 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Certa Dose, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k182162/ 2018-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k182162-optibond-extra-universal-fda-510k.jpg K182162 - OptiBond eXTRa Universal K182162 is a FDA 510(k) cleared dental medical device. Manufacturer: Kerr Corporation. Cleared Nov 2018. https://www.510kdatabase.net/k182220/ 2018-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k182220-curbell-branded-patient-monitoring-fda-510k.jpg K182220 - Curbell branded Patient Monitoring Cables K182220 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Curbell Medical Products, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k182467/ 2018-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k182467-simplexa-gbs-direct-simplexa-gbs-fda-510k.jpg K182467 - Simplexa GBS Direct, Simplexa GBS Positive Control Pack K182467 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Diasorin Molecular, LLC. Cleared Nov 2018. https://www.510kdatabase.net/k172668/ 2018-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k172668-w-zirconia-implants-fda-510k.jpg K172668 - W Zirconia Implants K172668 is a FDA 510(k) cleared dental medical device. Manufacturer: Tav Medical , Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k173857/ 2018-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k173857-elecsys-tacrolimus-fda-510k.jpg K173857 - Elecsys Tacrolimus K173857 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics. Cleared Nov 2018. https://www.510kdatabase.net/k173916/ 2018-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k173916-finapres-nova-noninvasive-hemodynamic-fda-510k.jpg K173916 - Finapres Nova Noninvasive Hemodynamic Monitor K173916 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Finapres Medical Systems B.V.. Cleared Nov 2018. https://www.510kdatabase.net/k180469/ 2018-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k180469-imajin-silicone-hydro-coated-double-fda-510k.jpg K180469 - ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent K180469 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Coloplast Corp.. Cleared Nov 2018. https://www.510kdatabase.net/k180838/ 2018-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k180838-salipen-fda-510k.jpg K180838 - SaliPen K180838 is a FDA 510(k) cleared dental medical device. Manufacturer: Saliwell , Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k181613/ 2018-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k181613-magnetom-avanto-magnetom-verio-with-fda-510k.jpg K181613 - MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11D K181613 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k181757/ 2018-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k181757-gnther-tulip-vena-cava-filter-fda-510k.jpg K181757 - Günther Tulip® Vena Cava Filter Retrieval Set K181757 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Nov 2018. https://www.510kdatabase.net/k181819/ 2018-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k181819-smartrelease-endoscopic-soft-tissue-fda-510k.jpg K181819 - SMARTRELEASE Endoscopic Soft Tissue Release System K181819 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Microaire Surgical Instruments, LLC. Cleared Nov 2018. https://www.510kdatabase.net/k181846/ 2018-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k181846-assure-anterior-cervical-plate-system-fda-510k.jpg K181846 - ASSURE Anterior Cervical Plate System, PROVIDENCE Anterior Cervical Plate System, VIP Anterior Cervical Plate System, XTEND Anterior Cervical Plate System, UNIFY Dynamic Anterior Cervical Plate System, CITADEL Anterior Lumbar Plate System, TRUSS Thoracolumbar Plate System, PLYMOUTH Thoracolumbar Plate System, SP-Fix Spinous Process Fixation Plate, RELIEVE Laminoplasty Fixation System K181846 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k181934/ 2018-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k181934-vivid-t8-vivid-t9-fda-510k.jpg K181934 - Vivid T8, Vivid T9 K181934 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. Cleared Nov 2018. https://www.510kdatabase.net/k181939/ 2018-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k181939-icobrain-fda-510k.jpg K181939 - icobrain K181939 is a FDA 510(k) cleared radiology medical device. Manufacturer: Icometrix NV. Cleared Nov 2018. https://www.510kdatabase.net/k182216/ 2018-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k182216-merit-syringe-fda-510k.jpg K182216 - Merit Syringe K182216 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k182279/ 2018-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k182279-merit-syringe-fda-510k.jpg K182279 - Merit Syringe K182279 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k182425/ 2018-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k182425-universal-mesh-sterile-fda-510k.jpg K182425 - Universal Mesh - Sterile K182425 is a FDA 510(k) cleared neurology medical device. Manufacturer: Stryker Leibinger GmbH & Co KG. Cleared Nov 2018. https://www.510kdatabase.net/k182442/ 2018-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k182442-miniguard-arterial-safety-valve-fda-510k.jpg K182442 - MiniGuard Arterial Safety Valve K182442 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quest Medical, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k182444/ 2018-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k182444-erbeflo-olympus-scope-port-connector-fda-510k.jpg K182444 - ERBEFLO Olympus Scope Port Connector K182444 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Erbe USA, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k182451/ 2018-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k182451-bizact-tonsillectomy-device-advanced-fda-510k.jpg K182451 - BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider K182451 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Covidien, LLC. Cleared Nov 2018. https://www.510kdatabase.net/den170049/ 2018-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/den170049-innovo-fda-510k.jpg DEN170049 - Innovo DEN170049 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Bio-Medical Research, Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k180801/ 2018-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k180801-actreen-hi-lite-cath-actreen-hi-lite-set-fda-510k.jpg K180801 - Actreen Hi-Lite Cath, Actreen Hi-Lite Set K180801 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k181258/ 2018-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k181258-connectedor-hub-with-device-and-voice-fda-510k.jpg K181258 - ConnectedOR Hub with Device and Voice Control K181258 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker. Cleared Nov 2018. https://www.510kdatabase.net/k181288/ 2018-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k181288-athelas-one-fda-510k.jpg K181288 - Athelas One K181288 is a FDA 510(k) cleared hematology medical device. Manufacturer: Athelas, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k181781/ 2018-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k181781-dynacliptm-bone-staple-fda-510k.jpg K181781 - DynaClipTM Bone Staple K181781 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: MedShape, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k182095/ 2018-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k182095-tina-quant-transferrin-ver2-urine-fda-510k.jpg K182095 - Tina-quant Transferrin ver.2 (urine application) K182095 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics Operations (Rdo). Cleared Nov 2018. https://www.510kdatabase.net/k182160/ 2018-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k182160-1688-camera-control-unit-fda-510k.jpg K182160 - 1688 Camera Control Unit K182160 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker. Cleared Nov 2018. https://www.510kdatabase.net/k182559/ 2018-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k182559-premier-platinum-hpsa-plus-fda-510k.jpg K182559 - PREMIER Platinum HpSA PLUS K182559 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Meridian Bioscience, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k180180/ 2018-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k180180-hanarostent-lowaxtm-colonrectum-nnn-fda-510k.jpg K180180 - HANAROSTENT LowAxTM Colon/Rectum (NNN), HANAROSTENT LowAxTM Duodenum/Pylorus (NNN) K180180 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: M.I. Tech Co., Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k180253/ 2018-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k180253-sheridan-endobronchial-tubes-fda-510k.jpg K180253 - Sheridan Endobronchial Tubes K180253 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Teleflex Medical. Cleared Nov 2018. https://www.510kdatabase.net/k180415/ 2018-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k180415-invia-white-foam-npwt-fda-510k.jpg K180415 - Invia White Foam NPWT K180415 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medela AG. Cleared Nov 2018. https://www.510kdatabase.net/k180601/ 2018-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k180601-rotograph-prime-3d-under-trade-mark-fda-510k.jpg K180601 - Rotograph Prime 3D (under Trade mark Villa Sistemi Medicali), I-MAX 3D (under Trade mark Owandy Radiology) K180601 is a FDA 510(k) cleared radiology medical device. Manufacturer: Villa Sistemi Medicali S.P.A.. Cleared Nov 2018. https://www.510kdatabase.net/k180786/ 2018-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k180786-sterile-nitrile-powder-free-fda-510k.jpg K180786 - Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Aqua Blue (ABLU), Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs Violet Blue (VBLU) - Extended Cuff K180786 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hartalega Sdn Bhd. Cleared Nov 2018. https://www.510kdatabase.net/k181195/ 2018-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k181195-clearpoint-system-fda-510k.jpg K181195 - ClearPoint System K181195 is a FDA 510(k) cleared neurology medical device. Manufacturer: Mri Interventions, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k181208/ 2018-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k181208-vygon-midline-3-fr-sl-catheter-fda-510k.jpg K181208 - Vygon Midline 3 Fr SL Catheter K181208 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Vygon USA. Cleared Nov 2018. https://www.510kdatabase.net/k181403/ 2018-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k181403-innova-igs-5-innova-igs-6-discovery-fda-510k.jpg K181403 - Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR K181403 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Nov 2018. https://www.510kdatabase.net/k181501/ 2018-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k181501-afina-fda-510k.jpg K181501 - Afina K181501 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Neurovision Imaging, LLC. Cleared Nov 2018. https://www.510kdatabase.net/k181639/ 2018-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k181639-panta-2-arthrodesis-nail-system-fda-510k.jpg K181639 - Panta 2 Arthrodesis Nail System K181639 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Integra LifeSciences Corporation. Cleared Nov 2018. https://www.510kdatabase.net/k181837/ 2018-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k181837-spinal-elements-ti-bond-coated-devices-fda-510k.jpg K181837 - Spinal Elements Ti-Bond coated devices K181837 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinal Elements, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k181911/ 2018-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k181911-interlude-100-cotton-tampon-fda-510k.jpg K181911 - Interlude 100% Cotton Tampon K181911 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Albaad Fem. Cleared Nov 2018. https://www.510kdatabase.net/k182077/ 2018-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k182077-mazor-x-system-mazor-x-stealth-edition-fda-510k.jpg K182077 - Mazor X System (Mazor X Stealth Edition) K182077 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Mazor Robotics , Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k182096/ 2018-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k182096-halyard-purple-nitrile-max-powder-free-fda-510k.jpg K182096 - Halyard Purple Nitrile Max Powder-Free Exam Gloves for Use with Chemotherapy Drugs K182096 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Owens & Minor Halyard, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k182104/ 2018-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k182104-navlock-trackers-robotic-reference-frame-fda-510k.jpg K182104 - NavLock Trackers, Robotic Reference Frame K182104 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Navigation. Cleared Nov 2018. https://www.510kdatabase.net/k182110/ 2018-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k182110-cdi-blood-parameter-monitoring-system-fda-510k.jpg K182110 - CDI Blood Parameter Monitoring System 550 K182110 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Cardiovascular Systems Corporation. Cleared Nov 2018. https://www.510kdatabase.net/k182121/ 2018-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k182121-cd-horizon-spinal-system-instruments-fda-510k.jpg K182121 - CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition K182121 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k182127/ 2018-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k182127-wrist-blood-pressure-monitor-model-fda-510k.jpg K182127 - Wrist Blood Pressure Monitor Model BP6100 K182127 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Omron Healthcare, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k182270/ 2018-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k182270-cellene-co2-laser-system-fda-510k.jpg K182270 - Cellene CO2 Laser System K182270 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bio-Med USA, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k182405/ 2018-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k182405-dexcom-pro-q-continuous-glucose-fda-510k.jpg K182405 - Dexcom Pro Q Continuous Glucose Monitoring System K182405 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dexcom, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k182427/ 2018-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k182427-aplio-a550-and-a450-software-v28-fda-510k.jpg K182427 - Aplio a550 and a450, Software V2.8 Diagnostic Ultrasound System K182427 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Nov 2018. https://www.510kdatabase.net/k182557/ 2018-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k182557-mts-eravacycline-0002-32-gml-fda-510k.jpg K182557 - MTS Eravacycline 0.002 - 32 µg/mL K182557 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Liofilchem S. R. L.. Cleared Nov 2018. https://www.510kdatabase.net/k182596/ 2018-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k182596-xario200g-and-xario100g-software-v11-fda-510k.jpg K182596 - Xario200G and Xario100G, Software V1.1 Diagnostic Ultrasound System K182596 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Nov 2018. https://www.510kdatabase.net/k182616/ 2018-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k182616-nvisionvle-imaging-system-nvisionvle-fda-510k.jpg K182616 - NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System K182616 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ninepoint Medical, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k182823/ 2018-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k182823-prodense-bone-graft-substitute-fda-510k.jpg K182823 - PRODENSE Bone Graft Substitute K182823 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Nov 2018. https://www.510kdatabase.net/den170056/ 2018-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/den170056-parathyroid-detection-model-pteye-system-fda-510k.jpg DEN170056 - Parathyroid Detection (Model PTeye) System DEN170056 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aibiomed, Corp.. Cleared Nov 2018. https://www.510kdatabase.net/den170092/ 2018-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/den170092-fluobeam-800-clinic-imaging-device-fda-510k.jpg DEN170092 - Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control System DEN170092 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Fluoptics. Cleared Nov 2018. https://www.510kdatabase.net/k180247/ 2018-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k180247-daehan-adhesive-surface-electrodes-fda-510k.jpg K180247 - DAEHAN Adhesive Surface Electrodes K180247 is a FDA 510(k) cleared neurology medical device. Manufacturer: Daehan Medical Systems Co., Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k180310/ 2018-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k180310-depuy-synthes-trauma-orthopedic-plates-fda-510k.jpg K180310 - DePuy Synthes Trauma Orthopedic Plates and Screws K180310 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k180363/ 2018-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k180363-clear-tip-eus-fna-fda-510k.jpg K180363 - Clear-Tip EUS-FNA K180363 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Finemedix Co., Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k181049/ 2018-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k181049-spectra-optia-apheresis-system-fda-510k.jpg K181049 - Spectra Optia Apheresis System K181049 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Terumobct, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k181266/ 2018-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k181266-implantswiss-dental-implant-system-fda-510k.jpg K181266 - Implantswiss Dental Implant System, Implantswiss Dental Abutment System K181266 is a FDA 510(k) cleared dental medical device. Manufacturer: Novodent SA. Cleared Nov 2018. https://www.510kdatabase.net/k181273/ 2018-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k181273-glucocard-shine-connex-blood-glucose-fda-510k.jpg K181273 - GLUCOCARD Shine Connex Blood Glucose Monitoring System, GLUCOCARD Shine Express Blood Glucose Monitoring System K181273 is a FDA 510(k) cleared chemistry medical device. Manufacturer: I-Sens, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k181820/ 2018-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k181820-medline-unite-mini-plates-and-screws-fda-510k.jpg K181820 - Medline Unite Mini Plates and Screws K181820 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medline Industries, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k182098/ 2018-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k182098-n-latex-flc-kappa-assay-n-latex-flc-fda-510k.jpg K182098 - N Latex FLC kappa assay, N Latex FLC lambda assay K182098 is a FDA 510(k) cleared immunology medical device. Manufacturer: Siemens Healthcare Diagnostics Products GmbH. Cleared Nov 2018. https://www.510kdatabase.net/k182273/ 2018-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k182273-medrad-stellant-flex-ct-injection-fda-510k.jpg K182273 - MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT K182273 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bayer Medical Care, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k182276/ 2018-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k182276-medrad-mrxperion-mr-injection-system-fda-510k.jpg K182276 - MEDRAD MRXperion MR Injection System and MR Injection System Syringe Kit K182276 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bayer Medical Care, Inc.. Cleared Nov 2018. https://www.510kdatabase.net/k182523/ 2018-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k182523-largan-55-uv-color-ocufilcon-d-daily-fda-510k.jpg K182523 - Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens K182523 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Largan Medical Co., Ltd.. Cleared Nov 2018. https://www.510kdatabase.net/k171199/ 2018-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k171199-aview-fda-510k.jpg K171199 - AVIEW K171199 is a FDA 510(k) cleared radiology medical device. Manufacturer: Coreline Soft Co., Ltd.. Cleared Oct 2018. https://www.510kdatabase.net/k171585/ 2018-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k171585-luxen-zr-luxen-smile-fda-510k.jpg K171585 - LUXEN Zr, LUXEN Smile K171585 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentalmax Co., Ltd.. Cleared Oct 2018. https://www.510kdatabase.net/k173351/ 2018-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k173351-panpac-flexi-shelf-pessary-fda-510k.jpg K173351 - Panpac Flexi Shelf Pessary K173351 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Panpac Medical Corporation. Cleared Oct 2018. https://www.510kdatabase.net/k180735/ 2018-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k180735-endomat-select-fda-510k.jpg K180735 - Endomat Select K180735 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Karl Storz SE & CO. KG. Cleared Oct 2018. https://www.510kdatabase.net/k180899/ 2018-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k180899-universal-base-abutment-fda-510k.jpg K180899 - Universal Base Abutment K180899 is a FDA 510(k) cleared dental medical device. Manufacturer: Nobel Biocare AB. Cleared Oct 2018. https://www.510kdatabase.net/k181553/ 2018-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k181553-immunalysis-ethyl-alcohol-enzyme-assay-fda-510k.jpg K181553 - Immunalysis Ethyl Alcohol Enzyme Assay K181553 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Immunalysis Corporation. Cleared Oct 2018. https://www.510kdatabase.net/k181994/ 2018-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k181994-single-use-aspiration-needle-na-u201h-fda-510k.jpg K181994 - Single Use Aspiration Needle NA-U201H K181994 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Oct 2018. https://www.510kdatabase.net/k182082/ 2018-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k182082-tumark-for-eviva-tumark-for-brevera-fda-510k.jpg K182082 - Tumark for Eviva, Tumark for Brevera K182082 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Somatex Medical Technologies GmbH. Cleared Oct 2018. https://www.510kdatabase.net/k182085/ 2018-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k182085-balanced-knee-revision-system-fda-510k.jpg K182085 - Balanced Knee Revision System Trabecular Tibial Cone Augments K182085 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ortho Development Corporation. Cleared Oct 2018. https://www.510kdatabase.net/k182087/ 2018-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k182087-dynamesh-posterior-fda-510k.jpg K182087 - DynaMesh-POSTERIOR K182087 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Feg Textiltechnik Forschungs- Und Entwicklungsgesellschaft. Cleared Oct 2018. https://www.510kdatabase.net/k182088/ 2018-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k182088-xs-dynamis-xp-dynamis-sp-dynamis-xp-fda-510k.jpg K182088 - XS Dynamis, XP Dynamis, SP Dynamis, XP Spectro, SP Spectro K182088 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Fotona D.O.O.. Cleared Oct 2018. https://www.510kdatabase.net/k182588/ 2018-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k182588-medline-renewal-reprocessed-ligasure-fda-510k.jpg K182588 - Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider K182588 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Surgical Instrument Service and Savings Inc.(Dba Medline Ren. Cleared Oct 2018. https://www.510kdatabase.net/k182679/ 2018-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k182679-aplio-i900i800i700i600-diagnostic-fda-510k.jpg K182679 - Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V3.1 K182679 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Oct 2018. https://www.510kdatabase.net/k182880/ 2018-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k182880-halifax-imaging-kit-fda-510k.jpg K182880 - Halifax Imaging Kit K182880 is a FDA 510(k) cleared radiology medical device. Manufacturer: Halifax Biomedical, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/den180028/ 2018-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/den180028-23andme-personal-genome-service-pgs-fda-510k.jpg DEN180028 - 23andMe Personal Genome Service (PGS) Pharmacogenetic Reports DEN180028 is a FDA 510(k) cleared chemistry medical device. Manufacturer: 23AndMe, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k180354/ 2018-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k180354-urogen-ureteral-catheter-fda-510k.jpg K180354 - UroGen Ureteral Catheter K180354 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Urogen Pharma, Ltd.. Cleared Oct 2018. https://www.510kdatabase.net/k180718/ 2018-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k180718-orthodontic-plastic-brackets-and-fda-510k.jpg K180718 - ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES K180718 is a FDA 510(k) cleared dental medical device. Manufacturer: Tomy, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k181488/ 2018-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k181488-ligaclip-12mm-l-endoscopic-rotating-fda-510k.jpg K181488 - LIGACLIP 12mm L Endoscopic Rotating Multiple Clip Applier K181488 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon Endo-Surgery, LLC. Cleared Oct 2018. https://www.510kdatabase.net/k181550/ 2018-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k181550-cios-spin-fda-510k.jpg K181550 - Cios Spin K181550 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k182062/ 2018-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k182062-sysmex-ud-10-fully-automated-urine-fda-510k.jpg K182062 - Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device K182062 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sysmex America, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k182063/ 2018-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k182063-vitros-chemistry-products-crbm-slides-fda-510k.jpg K182063 - VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated System K182063 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Ortho-Clinical Diagnostics, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k182066/ 2018-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k182066-obrien-suprapubic-introducer-set-cook-fda-510k.jpg K182066 - O'Brien Suprapubic Introducer Set, Cook SP Tube Introducer Set K182066 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Oct 2018. https://www.510kdatabase.net/k182072/ 2018-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k182072-vitros-chemistry-products-cl-slides-fda-510k.jpg K182072 - VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU Slides K182072 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Ortho-Clinical Diagnostics, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k182381/ 2018-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k182381-wilson-cook-mini-basket-fda-510k.jpg K182381 - Wilson-Cook Mini Basket K182381 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Wilson-Cook Medical, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k182392/ 2018-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k182392-frozen-c-fda-510k.jpg K182392 - Frozen C K182392 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: B.M. Tech. Worldwide Co., Ltd.. Cleared Oct 2018. https://www.510kdatabase.net/k182466/ 2018-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k182466-aos-calcaneal-plating-system-fda-510k.jpg K182466 - AOS Calcaneal Plating System K182466 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Advanced Orthopaedic Solutions. Cleared Oct 2018. https://www.510kdatabase.net/k182540/ 2018-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k182540-dilumen-endolumenal-interventional-fda-510k.jpg K182540 - DiLumen Endolumenal Interventional Platform K182540 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Lumendi, LLC. Cleared Oct 2018. https://www.510kdatabase.net/k180020/ 2018-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k180020-hemoscreen-hematology-analyzer-fda-510k.jpg K180020 - HemoScreen Hematology Analyzer K180020 is a FDA 510(k) cleared hematology medical device. Manufacturer: Pixcell Medical Technologies, Ltd.. Cleared Oct 2018. https://www.510kdatabase.net/k180559/ 2018-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k180559-hsv-1-2-elite-mgb-kit-fda-510k.jpg K180559 - HSV 1 & 2 ELITe MGB Kit K180559 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Elitechgroup. Cleared Oct 2018. https://www.510kdatabase.net/k181239/ 2018-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k181239-infrared-forehead-thermometer-infrared-fda-510k.jpg K181239 - Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer K181239 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Joytech Healthcare Co. , Ltd.. Cleared Oct 2018. https://www.510kdatabase.net/k182215/ 2018-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k182215-clearlink-controlled-phototherapy-fda-510k.jpg K182215 - ClearLink Controlled Phototherapy Equipment K182215 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Daavlin Distributing Company. Cleared Oct 2018. https://www.510kdatabase.net/k182914/ 2018-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k182914-mc3-vascular-access-kit-21030-fda-510k.jpg K182914 - MC3 Vascular Access Kit 21030 K182914 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Mc3 Incorporated. Cleared Oct 2018. https://www.510kdatabase.net/k180980/ 2018-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k180980-orthros-posterior-stabilization-system-fda-510k.jpg K180980 - ORTHROS™ Posterior Stabilization System K180980 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Camber Spine Technologies, LLC. Cleared Oct 2018. https://www.510kdatabase.net/k181458/ 2018-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k181458-reprocessed-advisor-fl-sensor-enabled-fda-510k.jpg K181458 - Reprocessed Advisor FL Sensor Enabled Circular Mapping Catheter K181458 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Innovative Health, LLC. Cleared Oct 2018. https://www.510kdatabase.net/k170732/ 2018-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k170732-biomate-dental-implant-system-fda-510k.jpg K170732 - Biomate Dental Implant System K170732 is a FDA 510(k) cleared dental medical device. Manufacturer: Biomate Medical Devices Technology Co., Ltd.. Cleared Oct 2018. https://www.510kdatabase.net/k173965/ 2018-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k173965-implant-planning-software-fda-510k.jpg K173965 - Implant Planning Software K173965 is a FDA 510(k) cleared radiology medical device. Manufacturer: Inteware Co., Ltd.. Cleared Oct 2018. https://www.510kdatabase.net/k180285/ 2018-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k180285-pentax-medical-video-colonoscope-ec34-fda-510k.jpg K180285 - PENTAX Medical Video Colonoscope EC34-i10T Series K180285 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Pentax Medical of America, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k180286/ 2018-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k180286-polyethylene-catheter-fda-510k.jpg K180286 - Polyethylene Catheter K180286 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Oct 2018. https://www.510kdatabase.net/k180291/ 2018-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k180291-cook-silicone-balloon-hsg-catheter-fda-510k.jpg K180291 - Cook Silicone Balloon HSG Catheter K180291 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Cook Incorporated. Cleared Oct 2018. https://www.510kdatabase.net/k180300/ 2018-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k180300-margolin-hsg-cannula-goldstein-fda-510k.jpg K180300 - Margolin HSG Cannula, Goldstein Sonohysterography Catheter K180300 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Cook Incorporated. Cleared Oct 2018. https://www.510kdatabase.net/k180487/ 2018-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k180487-peakme-fda-510k.jpg K180487 - Peak.me K180487 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Breathe Me, Ltd.. Cleared Oct 2018. https://www.510kdatabase.net/k181031/ 2018-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k181031-tsi-transseptal-introducer-fda-510k.jpg K181031 - TSI Transseptal Introducer K181031 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Pressure Products Medical Device Manufacturing, LLC. Cleared Oct 2018. https://www.510kdatabase.net/k181739/ 2018-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k181739-invisalign-system-with-mandibular-fda-510k.jpg K181739 - Invisalign System with Mandibular Advancement Feature K181739 is a FDA 510(k) cleared dental medical device. Manufacturer: Align Technology, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k181898/ 2018-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k181898-two-step-implant-system-fda-510k.jpg K181898 - Two-Step Implant System K181898 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Trilliant Surgical. Cleared Oct 2018. https://www.510kdatabase.net/k182041/ 2018-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k182041-dexcom-g6-glucose-program-continuous-fda-510k.jpg K182041 - Dexcom G6 Glucose Program Continuous Glucose Monitoring System K182041 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dexcom, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k182177/ 2018-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k182177-accipiolx-fda-510k.jpg K182177 - Accipiolx K182177 is a FDA 510(k) cleared radiology medical device. Manufacturer: Maxq-Al , Ltd.. Cleared Oct 2018. https://www.510kdatabase.net/k182299/ 2018-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k182299-magnetom-aera-fda-510k.jpg K182299 - MAGNETOM Aera K182299 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k182501/ 2018-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k182501-hair-laser-headband-fda-510k.jpg K182501 - Hair Laser Headband K182501 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Pulsaderm, LLC. Cleared Oct 2018. https://www.510kdatabase.net/k182753/ 2018-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k182753-a6-otc-pain-relief-tens-fda-510k.jpg K182753 - A6 OTC Pain Relief TENS K182753 is a FDA 510(k) cleared neurology medical device. Manufacturer: Everyway Medical Instruments Co.,Ltd. Cleared Oct 2018. https://www.510kdatabase.net/k182767/ 2018-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k182767-v2-otc-pain-relief-tens-fda-510k.jpg K182767 - V2 OTC Pain Relief TENS K182767 is a FDA 510(k) cleared neurology medical device. Manufacturer: Everyway Medical Instruments Co.,Ltd. Cleared Oct 2018. https://www.510kdatabase.net/k170723/ 2018-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k170723-swaive-thermometer-swt1a-fda-510k.jpg K170723 - Swaive Thermometer SWT1A K170723 is a FDA 510(k) cleared general hospital medical device. Manufacturer: E-Care Technology Co., Ltd.. Cleared Oct 2018. https://www.510kdatabase.net/k173944/ 2018-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k173944-endocular-viewing-lenses-and-silicone-fda-510k.jpg K173944 - Endocular Viewing Lenses and Silicone Ring K173944 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Phakos. Cleared Oct 2018. https://www.510kdatabase.net/k180258/ 2018-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k180258-speedicath-standard-fda-510k.jpg K180258 - SpeediCath Standard K180258 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Coloplast. Cleared Oct 2018. https://www.510kdatabase.net/k180688/ 2018-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k180688-slendertone-corefit-abs-8-type-734-fda-510k.jpg K180688 - SLENDERTONE CoreFit Abs 8, Type 734 K180688 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Bio-Medical Research, Ltd.. Cleared Oct 2018. https://www.510kdatabase.net/k181116/ 2018-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k181116-convivo-fda-510k.jpg K181116 - CONVIVO K181116 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Carl Zeiss Meditec, AG. Cleared Oct 2018. https://www.510kdatabase.net/k181186/ 2018-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k181186-solitare-platinum-revascularization-fda-510k.jpg K181186 - Solitare Platinum Revascularization Device K181186 is a FDA 510(k) cleared neurology medical device. Manufacturer: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. Cleared Oct 2018. https://www.510kdatabase.net/k181354/ 2018-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k181354-074-zenith-flex-system-fda-510k.jpg K181354 - 074 Zenith Flex System K181354 is a FDA 510(k) cleared neurology medical device. Manufacturer: Inneuroco, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k181468/ 2018-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k181468-hybrid3d-fda-510k.jpg K181468 - Hybrid3D K181468 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hermes Medical Solutions AB. Cleared Oct 2018. https://www.510kdatabase.net/k181685/ 2018-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k181685-vivid-e80-vivid-e90-vivid-e95-fda-510k.jpg K181685 - Vivid E80, Vivid E90, Vivid E95 K181685 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared Oct 2018. https://www.510kdatabase.net/k181902/ 2018-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k181902-codman-certas-plus-electronic-tool-kit-fda-510k.jpg K181902 - Codman Certas Plus Electronic Tool Kit K181902 is a FDA 510(k) cleared neurology medical device. Manufacturer: Integra Lifesciences Corp.. Cleared Oct 2018. https://www.510kdatabase.net/k181936/ 2018-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k181936-dyevert-plus-ez-contrast-reduction-fda-510k.jpg K181936 - DyeVert PLUS EZ Contrast Reduction System K181936 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Osprey Medical, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k181947/ 2018-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k181947-persona-revision-knee-system-fda-510k.jpg K181947 - Persona Revision Knee System K181947 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k182171/ 2018-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k182171-smv-scientific-k-wire-and-pins-fda-510k.jpg K182171 - SMV Scientific K-Wire and Pins K182171 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Summit Medventures. Cleared Oct 2018. https://www.510kdatabase.net/k182464/ 2018-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k182464-peekmed-fda-510k.jpg K182464 - PeekMed K182464 is a FDA 510(k) cleared radiology medical device. Manufacturer: Peek Health, S.A.. Cleared Oct 2018. https://www.510kdatabase.net/k182706/ 2018-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k182706-external-upper-limb-tremor-stimulator-fda-510k.jpg K182706 - External upper limb tremor stimulator K182706 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cala Health, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k173603/ 2018-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k173603-monarch-airway-clearance-system-fda-510k.jpg K173603 - Monarch Airway Clearance System K173603 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Hill-Rom Holdings, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k173756/ 2018-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k173756-certus-140-245ghz-ablation-system-fda-510k.jpg K173756 - Certus 140 2.45GHz Ablation System K173756 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Neuwave Medical, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k180275/ 2018-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k180275-vamp-optima-closed-blood-sampling-system-fda-510k.jpg K180275 - VAMP Optima closed blood sampling system K180275 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Oct 2018. https://www.510kdatabase.net/k180302/ 2018-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k180302-guardia-access-malleable-obturator-fda-510k.jpg K180302 - Guardia™ Access Malleable Obturator, Guardia™ Obturator, Soft-Pass™ Obturator, Soft-Trans Malleable Obturator, Guardia™ ETS Embryo-Tested Syringe, Flushing Catheter K180302 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Cook Incorporated. Cleared Oct 2018. https://www.510kdatabase.net/k180605/ 2018-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k180605-gastroflush-fda-510k.jpg K180605 - GastroFlush K180605 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Bionix Development Corporation. Cleared Oct 2018. https://www.510kdatabase.net/k180758/ 2018-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k180758-osteocera-resorbable-bone-substitute-fda-510k.jpg K180758 - Osteocera Resorbable Bone Substitute K180758 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wiltrom Corporation Limited. Cleared Oct 2018. https://www.510kdatabase.net/k180788/ 2018-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k180788-gas-module-3-fda-510k.jpg K180788 - Gas Module 3 K180788 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Oct 2018. https://www.510kdatabase.net/k180940/ 2018-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k180940-kodex-epd-system-fda-510k.jpg K180940 - KODEX EPD System K180940 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Oct 2018. https://www.510kdatabase.net/k181530/ 2018-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k181530-world-total-knee-system-fda-510k.jpg K181530 - World Total Knee System K181530 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Signature Orthopaedics Pty, Ltd.. Cleared Oct 2018. https://www.510kdatabase.net/k181560/ 2018-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k181560-cios-alpha-fda-510k.jpg K181560 - Cios Alpha K181560 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Systems USA, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k181596/ 2018-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k181596-spine-wave-navigated-instruments-fda-510k.jpg K181596 - Spine Wave Navigated Instruments K181596 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spine Wave, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k182140/ 2018-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k182140-da-vinci-xi-surgical-system-da-vinci-x-fda-510k.jpg K182140 - da Vinci Xi Surgical System, da Vinci X Surgical System K182140 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k182281/ 2018-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k182281-siterite-8-ultrasound-system-with-cue-fda-510k.jpg K182281 - Site~Rite 8 Ultrasound System with Cue Needle Tracking System and Pinpoint GT Needle Tech K182281 is a FDA 510(k) cleared radiology medical device. Manufacturer: C. R. Bard. Cleared Oct 2018. https://www.510kdatabase.net/k182318/ 2018-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k182318-retina-workplace-fda-510k.jpg K182318 - Retina Workplace K182318 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Carl Zeiss Meditec, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k182322/ 2018-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k182322-duo-lumbar-interbody-fusion-device-fda-510k.jpg K182322 - Duo Lumbar Interbody Fusion Device K182322 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spineology, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k182365/ 2018-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k182365-tempsure-system-fda-510k.jpg K182365 - TempSure System K182365 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cynosure, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k182647/ 2018-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k182647-gc70-fda-510k.jpg K182647 - GC70 K182647 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Electronics Co., Ltd.. Cleared Oct 2018. https://www.510kdatabase.net/den180004/ 2018-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/den180004-picoamh-elisa-fda-510k.jpg DEN180004 - picoAMH ELISA DEN180004 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Ansh Labs, LLC. Cleared Oct 2018. https://www.510kdatabase.net/k172670/ 2018-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k172670-bd-single-use-hypodermic-syringe-fda-510k.jpg K172670 - BD Single Use, Hypodermic Syringe K172670 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson and Company. Cleared Oct 2018. https://www.510kdatabase.net/k173824/ 2018-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k173824-humeral-short-stem-system-fda-510k.jpg K173824 - Humeral Short Stem System K173824 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Shoulder Innovations, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k180046/ 2018-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k180046-masimo-rad-97-and-accessories-fda-510k.jpg K180046 - Masimo Rad-97 and Accessories K180046 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Masimo Corporation. Cleared Oct 2018. https://www.510kdatabase.net/k180622/ 2018-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k180622-kangaroo-gastrostomy-feeding-tube-with-fda-510k.jpg K180622 - Kangaroo Gastrostomy Feeding Tube with ENFit Y-Port K180622 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Covidien. Cleared Oct 2018. https://www.510kdatabase.net/k181964/ 2018-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k181964-jivex-fda-510k.jpg K181964 - JiveX K181964 is a FDA 510(k) cleared radiology medical device. Manufacturer: Visus Health IT GmbH. Cleared Oct 2018. https://www.510kdatabase.net/k182002/ 2018-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k182002-cumulus-remover-fda-510k.jpg K182002 - Cumulus Remover K182002 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Kitazato Corporation. Cleared Oct 2018. https://www.510kdatabase.net/k182042/ 2018-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k182042-randox-calcium-ca-fda-510k.jpg K182042 - Randox Calcium (Ca) K182042 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Randox Laboratories, Ltd.. Cleared Oct 2018. https://www.510kdatabase.net/k182106/ 2018-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k182106-btl-799-2t-fda-510k.jpg K182106 - BTL 799-2T K182106 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: BTL Industries, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k182283/ 2018-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k182283-fuse-pedicle-screw-system-fda-510k.jpg K182283 - FUSE Pedicle Screw System K182283 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Black Box Medical. Cleared Oct 2018. https://www.510kdatabase.net/k182529/ 2018-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k182529-xperius-ultrasound-system-fda-510k.jpg K182529 - Xperius Ultrasound System K182529 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Ultrasound, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k182622/ 2018-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k182622-gu60a-gu60a-65-fda-510k.jpg K182622 - GU60A, GU60A-65 K182622 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Electronics Co., Ltd.. Cleared Oct 2018. https://www.510kdatabase.net/k172533/ 2018-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k172533-gm-implant-tubes-length-cutting-gauge-fda-510k.jpg K172533 - GM Implant Tubes, Length Cutting Gauge K172533 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k172733/ 2018-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k172733-td-1035-thermometer-fda-510k.jpg K172733 - TD-1035 Thermometer K172733 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Taidoc Technology Corporation. Cleared Oct 2018. https://www.510kdatabase.net/k180554/ 2018-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k180554-anthem-fracture-system-fda-510k.jpg K180554 - ANTHEM Fracture System K180554 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k181192/ 2018-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k181192-pip-fix-fda-510k.jpg K181192 - PIP Fix K181192 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Hand Biomechanics Lab, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k181248/ 2018-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k181248-comarch-e-care-platform-fda-510k.jpg K181248 - Comarch e-Care Platform K181248 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Comarch Healthcare SA. Cleared Oct 2018. https://www.510kdatabase.net/k181254/ 2018-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k181254-quadra-p-fda-510k.jpg K181254 - Quadra P K181254 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Oct 2018. https://www.510kdatabase.net/k181566/ 2018-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k181566-nutrifill-fda-510k.jpg K181566 - Nutrifill K181566 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Contamac, Ltd.. Cleared Oct 2018. https://www.510kdatabase.net/k181922/ 2018-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k181922-sonendo-material-a-fda-510k.jpg K181922 - Sonendo Material A K181922 is a FDA 510(k) cleared dental medical device. Manufacturer: Sonendo, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k181223/ 2018-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k181223-impact-fda-510k.jpg K181223 - ImPACT K181223 is a FDA 510(k) cleared neurology medical device. Manufacturer: Impact Applications, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k173594/ 2018-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k173594-straumann-cerabone-fda-510k.jpg K173594 - Straumann cerabone K173594 is a FDA 510(k) cleared dental medical device. Manufacturer: Institut Straumann AG. Cleared Oct 2018. https://www.510kdatabase.net/k180202/ 2018-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k180202-histofluor-rodent-lks-fluorescent-fda-510k.jpg K180202 - Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts K180202 is a FDA 510(k) cleared immunology medical device. Manufacturer: Immuno Concepts, N.A. , Ltd.. Cleared Oct 2018. https://www.510kdatabase.net/k180205/ 2018-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k180205-avelle-negative-pressure-wound-therapy-fda-510k.jpg K180205 - AVELLE Negative Pressure Wound Therapy System K180205 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Convatec Limited. Cleared Oct 2018. https://www.510kdatabase.net/k180213/ 2018-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k180213-titanium-tomofix-medial-high-tibia-fda-510k.jpg K180213 - Titanium TomoFix Medial High Tibia Plate Anatomical K180213 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes USA Products, LLC. Cleared Oct 2018. https://www.510kdatabase.net/k180516/ 2018-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k180516-echos-fda-510k.jpg K180516 - EchoS K180516 is a FDA 510(k) cleared radiology medical device. Manufacturer: Echolight S.P.A. Cleared Oct 2018. https://www.510kdatabase.net/k181433/ 2018-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k181433-magnetom-vida-fda-510k.jpg K181433 - MAGNETOM Vida K181433 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k181621/ 2018-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k181621-stable-c-interbody-system-fda-510k.jpg K181621 - Stable-C Interbody System K181621 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nexus Spine, LLC. Cleared Oct 2018. https://www.510kdatabase.net/k182264/ 2018-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k182264-iconn-revolution-knotless-suture-anchor-fda-510k.jpg K182264 - ICONN Revolution Knotless Suture Anchor K182264 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Iconn Orthopedics, LLC. Cleared Oct 2018. https://www.510kdatabase.net/k182282/ 2018-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k182282-vantage-orian-15t-mrt-1550-v45-fda-510k.jpg K182282 - Vantage Orian 1.5T, MRT-1550, V4.5 K182282 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Oct 2018. https://www.510kdatabase.net/k182450/ 2018-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k182450-vivid-s60n-vivid-s70n-fda-510k.jpg K182450 - Vivid S60N, Vivid S70N K182450 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared Oct 2018. https://www.510kdatabase.net/k182561/ 2018-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k182561-uronav-version-30-fda-510k.jpg K182561 - UroNav (Version 3.0) K182561 is a FDA 510(k) cleared radiology medical device. Manufacturer: Invivo Corporation. Cleared Oct 2018. https://www.510kdatabase.net/k182586/ 2018-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k182586-dlp-aortic-root-cannula-dlp-aortic-fda-510k.jpg K182586 - DLP Aortic Root Cannula, DLP Aortic Root Cannula with Vent Line, DLP Pressure Monitoring Extension Line Adapter, DLP Cardioplegia Adapter with Pressure Port K182586 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k182590/ 2018-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k182590-15t-air-mp-m-15t-air-mp-l-15t-16ch-air-fda-510k.jpg K182590 - 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AA K182590 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Oct 2018. https://www.510kdatabase.net/k182644/ 2018-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k182644-ensite-velocity-cardiac-mapping-system-fda-510k.jpg K182644 - EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2 K182644 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott. Cleared Oct 2018. https://www.510kdatabase.net/k182735/ 2018-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k182735-paragonix-sherpapak-cardiac-transport-fda-510k.jpg K182735 - Paragonix SherpaPak Cardiac Transport System K182735 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Paragonix Technologies. Cleared Oct 2018. https://www.510kdatabase.net/k180474/ 2018-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k180474-tni-softflow-50-fda-510k.jpg K180474 - TNI softFlow 50 K180474 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Tni Medical AG. Cleared Oct 2018. https://www.510kdatabase.net/k180708/ 2018-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k180708-entuit-lp-gastrostomy-br-low-profile-fda-510k.jpg K180708 - Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube, Entuit LP Gastrostomy BR Low Profile Balloon Retention Feeding Tube with ENFit Connection, Entuit LP Patient Care Kit, Entuit LP Patient Care Kit with ENFit Connection, PromaX Low Profile Gastrostomy Feeding Tube, PromaX LP Patient Care Kit with ENFit K180708 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Xeridiem Medical Devices, A Spectrum Plastics Group Company. Cleared Oct 2018. https://www.510kdatabase.net/k181373/ 2018-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k181373-extended-lipid-panel-assay-fda-510k.jpg K181373 - Extended Lipid Panel Assay K181373 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Laboratory Corporation of America Holdings. Cleared Oct 2018. https://www.510kdatabase.net/k181618/ 2018-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k181618-reprocessed-torqr-diagnostic-ep-catheter-fda-510k.jpg K181618 - Reprocessed Torqr Diagnostic EP Catheter K181618 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Innovative Health, LLC. Cleared Oct 2018. https://www.510kdatabase.net/k181718/ 2018-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k181718-bd-flowsmart-setminimed-pro-set-fda-510k.jpg K181718 - BD FlowSmart Set/MiniMed Pro-Set K181718 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson and Company. Cleared Oct 2018. https://www.510kdatabase.net/k181803/ 2018-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k181803-medax-biopsy-systems-iii-fda-510k.jpg K181803 - Medax Biopsy Systems III K181803 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medax Srl Unipersonale. Cleared Oct 2018. https://www.510kdatabase.net/k181941/ 2018-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k181941-swift-system-fda-510k.jpg K181941 - Swift System K181941 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Emblation , Ltd.. Cleared Oct 2018. https://www.510kdatabase.net/k181942/ 2018-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k181942-quantum-ventilation-module-fda-510k.jpg K181942 - Quantum Ventilation Module K181942 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Spectrum Medical , Ltd.. Cleared Oct 2018. https://www.510kdatabase.net/k181945/ 2018-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k181945-quickscreen-pro-multi-drug-screening-fda-510k.jpg K181945 - QuickScreen Pro Multi Drug Screening Test, Model 9395Z K181945 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Phamatech, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k182239/ 2018-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k182239-olympic-posterior-spinal-fixation-system-fda-510k.jpg K182239 - OLYMPIC Posterior Spinal Fixation System K182239 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Astura Medical, LLC. Cleared Oct 2018. https://www.510kdatabase.net/k182348/ 2018-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k182348-14hk701g-w-fda-510k.jpg K182348 - 14HK701G-W K182348 is a FDA 510(k) cleared radiology medical device. Manufacturer: Lg Electronics.Inc. Cleared Oct 2018. https://www.510kdatabase.net/k182569/ 2018-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k182569-spectralis-hraoct-and-variants-with-fda-510k.jpg K182569 - Spectralis HRA+OCT and variants with High Magnification Module K182569 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Heidelberg Engineering GmbH. Cleared Oct 2018. https://www.510kdatabase.net/k182591/ 2018-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k182591-radiforce-rx360-rx360-ar-fda-510k.jpg K182591 - RadiForce RX360, RX360-AR K182591 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eizo Corporation. Cleared Oct 2018. https://www.510kdatabase.net/k172709/ 2018-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k172709-elan-4-electro-motor-system-tools-fda-510k.jpg K172709 - ELAN 4 Electro Motor System Tools K172709 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k180240/ 2018-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k180240-full-automaticnibp-blood-pressure-fda-510k.jpg K180240 - Full Automatic(NIBP) Blood Pressure Monitor K180240 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Health & Life Co., Ltd.. Cleared Oct 2018. https://www.510kdatabase.net/k180345/ 2018-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k180345-uroject12-syringe-lever-fda-510k.jpg K180345 - Uroject12 Syringe Lever K180345 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Urogen Pharma, Ltd.. Cleared Oct 2018. https://www.510kdatabase.net/k180941/ 2018-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k180941-ortho-system-fda-510k.jpg K180941 - Ortho System K180941 is a FDA 510(k) cleared dental medical device. Manufacturer: 3Shape A/S. Cleared Oct 2018. https://www.510kdatabase.net/k181026/ 2018-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k181026-osteobridge-idsf-system-fda-510k.jpg K181026 - OsteoBridge™ IDSF System K181026 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Merete GmbH. Cleared Oct 2018. https://www.510kdatabase.net/k181728/ 2018-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k181728-muscle-trainer-fda-510k.jpg K181728 - Muscle Trainer K181728 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Shenzhen Kentro Medical Electronics Co., Ltd.. Cleared Oct 2018. https://www.510kdatabase.net/k182034/ 2018-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k182034-arterys-mica-fda-510k.jpg K182034 - Arterys MICA K182034 is a FDA 510(k) cleared radiology medical device. Manufacturer: Arterys, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k182240/ 2018-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k182240-pass-lp-spinal-system-fda-510k.jpg K182240 - PASS LP Spinal System K182240 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medicrea International SA. Cleared Oct 2018. https://www.510kdatabase.net/k182546/ 2018-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k182546-alphenix-infx-8000hb-v80-fda-510k.jpg K182546 - Alphenix, INFX-8000H/B, V8.0 K182546 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Oct 2018. https://www.510kdatabase.net/k182550/ 2018-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k182550-wireless-digital-flat-panel-detector-fda-510k.jpg K182550 - Wireless Digital Flat Panel Detector K182550 is a FDA 510(k) cleared radiology medical device. Manufacturer: Iray Technology Taicang , Ltd.. Cleared Oct 2018. https://www.510kdatabase.net/k182551/ 2018-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k182551-wireless-digital-flat-panel-detector-fda-510k.jpg K182551 - Wireless Digital Flat Panel Detector K182551 is a FDA 510(k) cleared radiology medical device. Manufacturer: Iray Technology Taicang , Ltd.. Cleared Oct 2018. https://www.510kdatabase.net/k182669/ 2018-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k182669-youlaser-co2-fda-510k.jpg K182669 - Youlaser CO2 K182669 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Quanta System Spa. Cleared Oct 2018. https://www.510kdatabase.net/k180568/ 2018-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k180568-kidcap-fda-510k.jpg K180568 - KidCap K180568 is a FDA 510(k) cleared neurology medical device. Manufacturer: Eastern Cranial Affiliates, LLC. Cleared Oct 2018. https://www.510kdatabase.net/k180971/ 2018-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k180971-quanta-flash-calprotectin-and-fecal-fda-510k.jpg K180971 - QUANTA Flash Calprotectin and Fecal Extraction Device K180971 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k181937/ 2018-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k181937-pump-in-style-advanced-advanced-fda-510k.jpg K181937 - Pump In Style Advanced, Advanced Personal Double Breastpump K181937 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Medela, LLC. Cleared Oct 2018. https://www.510kdatabase.net/k182154/ 2018-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k182154-depuy-synthes-femoral-neck-system-fda-510k.jpg K182154 - Depuy Synthes Femoral Neck System K182154 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes USA Products, LLC. Cleared Oct 2018. https://www.510kdatabase.net/k182261/ 2018-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k182261-nvisionvle-imaging-system-nvisionvle-fda-510k.jpg K182261 - NvisionVLE Imaging System, NvisionVLE Optical Probe K182261 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ninepoint Medical, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k182614/ 2018-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k182614-rct700-fda-510k.jpg K182614 - RCT700 K182614 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ray Co., Ltd.. Cleared Oct 2018. https://www.510kdatabase.net/k180418/ 2018-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k180418-relianttm-multistage-dilatation-fda-510k.jpg K180418 - Reliant(TM) Multistage Dilatation Balloon Catheter K180418 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Micro-Tech (Nanjing) Co., Ltd.. Cleared Oct 2018. https://www.510kdatabase.net/k181815/ 2018-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k181815-dynabridge-fda-510k.jpg K181815 - DynaBridge K181815 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Fusion Orthopedics, LLC. Cleared Oct 2018. https://www.510kdatabase.net/k181910/ 2018-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k181910-bracepaste-mtp-light-cure-primer-fda-510k.jpg K181910 - BracePaste MTP Light Cure Primer K181910 is a FDA 510(k) cleared dental medical device. Manufacturer: American Orthodontics. Cleared Oct 2018. https://www.510kdatabase.net/k182036/ 2018-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k182036-neuroblate-system-fda-510k.jpg K182036 - NeuroBlate System K182036 is a FDA 510(k) cleared neurology medical device. Manufacturer: Monteris Medical,. Cleared Oct 2018. https://www.510kdatabase.net/k182233/ 2018-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k182233-flowtriever-retrievalaspiration-system-fda-510k.jpg K182233 - FlowTriever Retrieval/Aspiration System K182233 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inari Medical. Cleared Oct 2018. https://www.510kdatabase.net/k180099/ 2018-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k180099-optilite-high-sensitivity-c-reactive-fda-510k.jpg K180099 - Optilite High Sensitivity C-Reactive Protein Kit K180099 is a FDA 510(k) cleared chemistry medical device. Manufacturer: The Binding Site Group , Ltd.. Cleared Oct 2018. https://www.510kdatabase.net/k180292/ 2018-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k180292-pentax-video-upper-gi-scope-eg34-i10-fda-510k.jpg K180292 - PENTAX Video Upper G.I. Scope EG34-i10 K180292 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Pentax Medical of America, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k180446/ 2018-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k180446-b-one-total-knee-system-fda-510k.jpg K180446 - b-ONE Total Knee System K180446 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: B-One Ortho, Corp.. Cleared Oct 2018. https://www.510kdatabase.net/k180620/ 2018-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k180620-endophys-pressure-sensing-sheath-kit-fda-510k.jpg K180620 - Endophys Pressure Sensing Sheath Kit K180620 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Endophys Holdings, LLC. Cleared Oct 2018. https://www.510kdatabase.net/k180991/ 2018-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k180991-ag-100s-fda-510k.jpg K180991 - AG 100s K180991 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Hospitech Respiration , Ltd.. Cleared Oct 2018. https://www.510kdatabase.net/k181220/ 2018-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k181220-juell-3d-volo-base-fda-510k.jpg K181220 - Juell 3D Volo Base K181220 is a FDA 510(k) cleared dental medical device. Manufacturer: Park Dental Research Corporation. Cleared Oct 2018. https://www.510kdatabase.net/k181539/ 2018-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k181539-ossdsign-cranioplug-fda-510k.jpg K181539 - OSSDSIGN Cranioplug K181539 is a FDA 510(k) cleared neurology medical device. Manufacturer: Ossdsign AB. Cleared Oct 2018. https://www.510kdatabase.net/k181569/ 2018-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k181569-bks-revision-sleeves-system-fda-510k.jpg K181569 - BKS Revision Sleeves System K181569 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ortho Development Corporation. Cleared Oct 2018. https://www.510kdatabase.net/k181607/ 2018-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k181607-thorecon-rigid-fixation-system-fda-510k.jpg K181607 - Thorecon Rigid Fixation System K181607 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: A & E Medical Corporation. Cleared Oct 2018. https://www.510kdatabase.net/k181640/ 2018-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k181640-x-bolt-hip-fracture-fixation-system-fda-510k.jpg K181640 - X-BOLT Hip Fracture Fixation System K181640 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: X-Bolt Orthopaedics. Cleared Oct 2018. https://www.510kdatabase.net/k181644/ 2018-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k181644-eit-cellular-titanium-lumbar-cage-llif-fda-510k.jpg K181644 - EIT Cellular Titanium® Lumbar Cage LLIF K181644 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Eit Emerging Implant Technologies GmbH. Cleared Oct 2018. https://www.510kdatabase.net/k181651/ 2018-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k181651-radial-medical-compression-system-fda-510k.jpg K181651 - Radial Medical Compression System K181651 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Radial Medical, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k181717/ 2018-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k181717-life-spine-laminoplasty-system-fda-510k.jpg K181717 - Life Spine Laminoplasty System K181717 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k181848/ 2018-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k181848-adapt-for-gamma3-gamma3-fda-510k.jpg K181848 - ADAPT for Gamma3, Gamma3 K181848 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker GmbH. Cleared Oct 2018. https://www.510kdatabase.net/k181852/ 2018-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k181852-percuvance-percutaneous-surgical-system-fda-510k.jpg K181852 - Percuvance Percutaneous Surgical System K181852 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Teleflexmedical, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k181999/ 2018-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k181999-integra-titan-reverse-shoulder-system-fda-510k.jpg K181999 - Integra TITAN Reverse Shoulder System K181999 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Integra LifeSciences Corporation. Cleared Oct 2018. https://www.510kdatabase.net/k182129/ 2018-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k182129-magnetom-sola-fda-510k.jpg K182129 - MAGNETOM Sola K182129 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k182237/ 2018-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k182237-umi-550-petct-system-fda-510k.jpg K182237 - uMI 550 PET/CT System K182237 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Oct 2018. https://www.510kdatabase.net/k182247/ 2018-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k182247-ilicon-ocufilcon-d-soft-hydrophilic-fda-510k.jpg K182247 - ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) K182247 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Vizionfocus, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k182504/ 2018-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k182504-30t-air-mp-m-30t-air-mp-l-fda-510k.jpg K182504 - 3.0T Air MP M, 3.0T Air MP L K182504 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare Coils (Usa Instruments, Inc.). Cleared Oct 2018. https://www.510kdatabase.net/k182522/ 2018-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k182522-penumbra-system-modified-110-fda-510k.jpg K182522 - Penumbra System (Modified 110 Aspiration Tubing) K182522 is a FDA 510(k) cleared neurology medical device. Manufacturer: Penumbra, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k182536/ 2018-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k182536-exactech-equinoxe-small-reverse-fda-510k.jpg K182536 - Exactech Equinoxe Small Reverse Shoulder Glenospheres , Exactech Equinoxe Reverse Shoulder Humeral Liners , Exactech Equinoxe Small Reverse Shoulder Glenoid Plates , Exactech Equinoxe Reverse Shoulder Locking Cap K182536 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k173920/ 2018-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k173920-ls-oil-fda-510k.jpg K173920 - LS OIL K173920 is a FDA 510(k) cleared dental medical device. Manufacturer: J. Morita USA, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k180249/ 2018-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k180249-omnipore-duromax-surgical-implants-fda-510k.jpg K180249 - OmniPore DUROMAX Surgical Implants K180249 is a FDA 510(k) cleared dental medical device. Manufacturer: Matrix Surgical Holdings, LLC/Matrix Surgical USA. Cleared Oct 2018. https://www.510kdatabase.net/k180555/ 2018-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k180555-ergoline-prestige-1600-hybrid-fda-510k.jpg K180555 - Ergoline Prestige 1600 Hybrid Performance K180555 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Jk Holding GmbH. Cleared Oct 2018. https://www.510kdatabase.net/k180680/ 2018-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k180680-salivea-dry-mouth-mouthwash-salivea-fda-510k.jpg K180680 - Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray K180680 is a FDA 510(k) cleared dental medical device. Manufacturer: Laclede, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k180872/ 2018-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k180872-scarlet-srf-fda-510k.jpg K180872 - SCARLET SRF K180872 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: VIOL Co., Ltd.. Cleared Oct 2018. https://www.510kdatabase.net/k181008/ 2018-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k181008-nuface-trinity-fda-510k.jpg K181008 - NuFACE Trinity K181008 is a FDA 510(k) cleared neurology medical device. Manufacturer: Carol Cole Company Dba Nuface. Cleared Oct 2018. https://www.510kdatabase.net/k181091/ 2018-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k181091-axsos-3-ti-fda-510k.jpg K181091 - AxSOS 3 Ti K181091 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker GmbH. Cleared Oct 2018. https://www.510kdatabase.net/k181330/ 2018-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k181330-neomatrix-wound-matrix-fda-510k.jpg K181330 - NeoMatriX Wound Matrix K181330 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Nextgen Biologics, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k181426/ 2018-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k181426-oralenteral-syringe-10-ml-to-60-ml-and-fda-510k.jpg K181426 - Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL) K181426 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Jiangsu Micsafe Medical Technology Co., Ltd.. Cleared Oct 2018. https://www.510kdatabase.net/k181460/ 2018-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k181460-onepacs-system-fda-510k.jpg K181460 - OnePacs System K181460 is a FDA 510(k) cleared radiology medical device. Manufacturer: Onepacs, LLC. Cleared Oct 2018. https://www.510kdatabase.net/k181503/ 2018-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k181503-fingertip-pulse-oximeter-fda-510k.jpg K181503 - Fingertip Pulse Oximeter K181503 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Beijing Choice Electronic Technology Co., Ltd.. Cleared Oct 2018. https://www.510kdatabase.net/k181520/ 2018-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k181520-sirona-dental-cadcam-system-fda-510k.jpg K181520 - Sirona Dental CAD/CAM System K181520 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona. Cleared Oct 2018. https://www.510kdatabase.net/k181578/ 2018-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k181578-demetech-ptfe-nonabsorbable-surgical-fda-510k.jpg K181578 - DemeTECH PTFE Nonabsorbable Surgical Suture K181578 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Demetech Corporation. Cleared Oct 2018. https://www.510kdatabase.net/k181617/ 2018-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k181617-e-cube-8-fda-510k.jpg K181617 - E-CUBE 8 K181617 is a FDA 510(k) cleared radiology medical device. Manufacturer: Alpinion Medical Systems Co., Ltd.. Cleared Oct 2018. https://www.510kdatabase.net/k182015/ 2018-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k182015-piccolo-composite-plate-system-fda-510k.jpg K182015 - Piccolo Composite® Plate System K182015 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: CarboFix Orthopedics , Ltd.. Cleared Oct 2018. https://www.510kdatabase.net/k182151/ 2018-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k182151-monet-anterior-cervical-interbody-fda-510k.jpg K182151 - MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate K182151 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ctl Medical Corporation. Cleared Oct 2018. https://www.510kdatabase.net/k182244/ 2018-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k182244-voyant-electrosurgical-generator-fda-510k.jpg K182244 - Voyant Electrosurgical Generator K182244 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Applied Medical Resources Corp.. Cleared Oct 2018. https://www.510kdatabase.net/k182826/ 2018-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k182826-ormco-spark-aligner-system-fda-510k.jpg K182826 - Ormco Spark Aligner System K182826 is a FDA 510(k) cleared dental medical device. Manufacturer: Sybron Dental Specialties. Cleared Oct 2018. https://www.510kdatabase.net/k172826/ 2018-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k172826-cellent-spinal-systems-fda-510k.jpg K172826 - Cellent Spinal Systems K172826 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Jiangsu Trauhui Medical Instrument Co., Ltd.. Cleared Oct 2018. https://www.510kdatabase.net/k173194/ 2018-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k173194-temperature-probe-fda-510k.jpg K173194 - Temperature Probe K173194 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Orantech, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k180467/ 2018-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k180467-sbg-blue-nitrile-powder-free-medical-fda-510k.jpg K180467 - SBG Blue Nitrile Powder Free Medical Examination Glove K180467 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Showa Best Glove, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k180468/ 2018-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k180468-sbg-black-nitrile-powder-free-medical-fda-510k.jpg K180468 - SBG Black Nitrile Powder Free Medical Examination Glove K180468 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Showa Best Glove, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k181038/ 2018-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k181038-cormatrix-cor-patch-3-cm-x-5-cmsingle-fda-510k.jpg K181038 - CorMatrix Cor Patch (3 cm x 5 cm)(single pack), CorMatrix Cor Patch (4 cm x 7 cm)(single pack), CorMatrix Cor Patch (7 cm x 10 cm)(single pack) K181038 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cormatrix Cardiovascular, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k181774/ 2018-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k181774-force-fiber-white-and-whiteblue-fda-510k.jpg K181774 - Force Fiber White and White/Blue, White/Black, Blue, and White/Green sutures K181774 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Teleflex Medical Incorporated. Cleared Oct 2018. https://www.510kdatabase.net/k181863/ 2018-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k181863-elvie-pump-fda-510k.jpg K181863 - Elvie Pump K181863 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Chiaro Technology Limited. Cleared Oct 2018. https://www.510kdatabase.net/k182070/ 2018-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k182070-biohorizons-tapered-im-implants-fda-510k.jpg K182070 - BioHorizons Tapered IM Implants K182070 is a FDA 510(k) cleared dental medical device. Manufacturer: BioHorizons Implant Systems, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k182289/ 2018-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k182289-sterile-high-pressure-angiographic-fda-510k.jpg K182289 - Sterile High-pressure Angiographic Syringes for Single-use K182289 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Baoan Medical Supplies Co., Ltd.. Cleared Oct 2018. https://www.510kdatabase.net/k182492/ 2018-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k182492-geminus-volar-distal-radius-plate-system-fda-510k.jpg K182492 - Geminus Volar Distal Radius Plate System K182492 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Skeletal Dynamics, LLC. Cleared Oct 2018. https://www.510kdatabase.net/k182531/ 2018-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k182531-clottriever-thrombectomy-system-fda-510k.jpg K182531 - ClotTriever Thrombectomy System K182531 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inari Medical. Cleared Oct 2018. https://www.510kdatabase.net/k181517/ 2018-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k181517-senhance-surgical-system-fda-510k.jpg K181517 - Senhance Surgical System K181517 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Transenterix, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k181818/ 2018-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k181818-scarlet-al-t-fda-510k.jpg K181818 - Scarlet AL-T K181818 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spineart. Cleared Oct 2018. https://www.510kdatabase.net/k181892/ 2018-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k181892-ziostation2-fda-510k.jpg K181892 - Ziostation2 K181892 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ziosoft, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k182490/ 2018-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k182490-swiss-lithoclast-trilogy-fda-510k.jpg K182490 - Swiss LithoClast Trilogy K182490 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: E.M.S Electro Medical Systems S.A. Cleared Oct 2018. https://www.510kdatabase.net/k182018/ 2018-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k182018-bluetooth-blood-pressure-monitor-fda-510k.jpg K182018 - Bluetooth blood pressure monitor K182018 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Kingyield Technology Co., Ltd.. Cleared Oct 2018. https://www.510kdatabase.net/k182117/ 2018-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k182117-vinyl-patient-examination-gloves-fda-510k.jpg K182117 - Vinyl Patient Examination Gloves K182117 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangxi Zhonghong Pulin Medical Products Co., Ltd.. Cleared Oct 2018. https://www.510kdatabase.net/k173945/ 2018-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k173945-straumann-sc-variobase-abutments-fda-510k.jpg K173945 - Straumann SC Variobase Abutments K173945 is a FDA 510(k) cleared dental medical device. Manufacturer: Institut Straumann AG. Cleared Oct 2018. https://www.510kdatabase.net/k180054/ 2018-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k180054-royal-flush-plus-high-flow-catheter-fda-510k.jpg K180054 - Royal Flush Plus High-Flow Catheter K180054 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Oct 2018. https://www.510kdatabase.net/k180919/ 2018-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k180919-gore-tri-lumen-catheter-fda-510k.jpg K180919 - GORE Tri-Lumen Catheter K180919 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W. L. Gore and Associates, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k181322/ 2018-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k181322-magnetom-sola-fda-510k.jpg K181322 - MAGNETOM Sola K181322 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k181531/ 2018-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k181531-spineex-sagittae-lateral-lumbar-fda-510k.jpg K181531 - SpineEX Sagittae Lateral Lumbar Interbody Fusion Devices K181531 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spineex, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k181587/ 2018-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k181587-ortholoc-sps-shoulder-plating-system-fda-510k.jpg K181587 - ORTHOLOC SPS Shoulder Plating System K181587 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tornier, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k181603/ 2018-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k181603-everest-spinal-system-range-mesa-and-fda-510k.jpg K181603 - EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System K181603 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: K2m, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k181642/ 2018-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k181642-b-laser-atherectomy-system-fda-510k.jpg K181642 - B-Laser Atherectomy System K181642 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Eximo Medical, Ltd.. Cleared Oct 2018. https://www.510kdatabase.net/k181725/ 2018-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k181725-ellipsys-vascular-access-system-fda-510k.jpg K181725 - Ellipsys Vascular Access System (Ellipsys System), (Power Controller Model No. AMI-1001 & Catheter & Needle Model No. AMI-6005) K181725 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Avenu Medical, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k181860/ 2018-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k181860-nuvasive-cohere-thoracolumbar-fda-510k.jpg K181860 - NuVasive Cohere Thoracolumbar Interbody System K181860 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Oct 2018. https://www.510kdatabase.net/k181868/ 2018-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k181868-shiny-rpl-system-fda-510k.jpg K181868 - SHINY RPL System K181868 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ids, Ltd.. Cleared Oct 2018. https://www.510kdatabase.net/k182112/ 2018-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k182112-sense-system-with-ibt-electrodes-fda-510k.jpg K182112 - Sense System with IBT Electrodes K182112 is a FDA 510(k) cleared neurology medical device. Manufacturer: Infinite Biomedical Technologies, LLC. Cleared Oct 2018. https://www.510kdatabase.net/den180026/ 2018-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/den180026-bose-hearing-aid-fda-510k.jpg DEN180026 - Bose Hearing Aid DEN180026 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Bose Corporation. Cleared Oct 2018. https://www.510kdatabase.net/k173076/ 2018-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k173076-cura-16-fda-510k.jpg K173076 - CURA 16 K173076 is a FDA 510(k) cleared radiology medical device. Manufacturer: Fmi Medical Systems, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k180209/ 2018-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k180209-diazyme-15-ag-assay-fda-510k.jpg K180209 - Diazyme 1,5-AG Assay K180209 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diazyme Laboratories, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k180736/ 2018-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k180736-wishbone-medical-plate-and-screw-system-fda-510k.jpg K180736 - WishBone Medical Plate and Screw System K180736 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wishbone Medical, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k181240/ 2018-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k181240-rhino-laryngo-fiberscope-olympus-enf-gp2-fda-510k.jpg K181240 - Rhino-Laryngo Fiberscope Olympus ENF-GP2 K181240 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Oct 2018. https://www.510kdatabase.net/k181949/ 2018-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k181949-symphony-oct-system-fda-510k.jpg K181949 - SYMPHONY™ OCT System K181949 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International SARL. Cleared Oct 2018. https://www.510kdatabase.net/k182059/ 2018-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k182059-prase-mis-spinal-system-fda-510k.jpg K182059 - Prase MIS Spinal System K182059 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Gbs Commonwealth Co., Ltd.. Cleared Oct 2018. https://www.510kdatabase.net/k182122/ 2018-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k182122-ureteric-catheters-fda-510k.jpg K182122 - Ureteric Catheters K182122 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Coloplast Corp.. Cleared Oct 2018. https://www.510kdatabase.net/k182189/ 2018-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k182189-encompass-srs-headframe-fda-510k.jpg K182189 - Encompass SRS Headframe K182189 is a FDA 510(k) cleared radiology medical device. Manufacturer: Qfix. Cleared Oct 2018. https://www.510kdatabase.net/k182337/ 2018-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k182337-hybrid-guidewire-fda-510k.jpg K182337 - HYBRID Guidewire K182337 is a FDA 510(k) cleared neurology medical device. Manufacturer: Balt USA, LLC. Cleared Oct 2018. https://www.510kdatabase.net/k182423/ 2018-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k182423-maglumi-2000-ft4-fda-510k.jpg K182423 - MAGLUMI 2000 FT4 K182423 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.. Cleared Oct 2018. https://www.510kdatabase.net/k182436/ 2018-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k182436-powerease-system-fda-510k.jpg K182436 - POWEREASE System K182436 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k182533/ 2018-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k182533-pixx-1717-fda-510k.jpg K182533 - PIXX 1717 K182533 is a FDA 510(k) cleared radiology medical device. Manufacturer: Pixxgen Corporation. Cleared Oct 2018. https://www.510kdatabase.net/k180972/ 2018-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k180972-arix-clavicle-system-fda-510k.jpg K180972 - ARIX Clavicle System K180972 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Jeil Medical Corporation. Cleared Oct 2018. https://www.510kdatabase.net/k181138/ 2018-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k181138-is-iii-active-system-fda-510k.jpg K181138 - IS-III active System K181138 is a FDA 510(k) cleared dental medical device. Manufacturer: Neobiotech Co., Ltd.. Cleared Oct 2018. https://www.510kdatabase.net/k181196/ 2018-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k181196-caretaker-remote-display-app-and-fda-510k.jpg K181196 - Caretaker Remote Display App and Caretaker Software Library K181196 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Caretaker Medical, LLC. Cleared Oct 2018. https://www.510kdatabase.net/k181370/ 2018-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k181370-umr-780-fda-510k.jpg K181370 - uMR 780 K181370 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Oct 2018. https://www.510kdatabase.net/k181371/ 2018-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k181371-umr-790-fda-510k.jpg K181371 - uMR 790 K181371 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Oct 2018. https://www.510kdatabase.net/k181527/ 2018-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k181527-on-call-sure-blood-glucose-monitoring-fda-510k.jpg K181527 - On Call Sure Blood Glucose Monitoring System, On Call Sure Sync Blood Glucose Monitoring System K181527 is a FDA 510(k) cleared chemistry medical device. Manufacturer: ACON Laboratories, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k181881/ 2018-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k181881-outlet-sacroiliac-joint-fusion-system-fda-510k.jpg K181881 - Outlet Sacroiliac Joint Fusion System K181881 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Sij Surgical. Cleared Oct 2018. https://www.510kdatabase.net/k181883/ 2018-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k181883-firefly-midline-navigation-guide-fda-510k.jpg K181883 - FIREFLY® Midline Navigation Guide K181883 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Mighty Oak Medical, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k181903/ 2018-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k181903-bravos-afterloader-family-bravos-fda-510k.jpg K181903 - BRAVOS Afterloader Family: BRAVOS Afterloader System, Transfer Guide Tubes, and Length Assessment Device K181903 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k182050/ 2018-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k182050-linear-accelerator-control-console-fda-510k.jpg K182050 - Linear Accelerator Control Console Software v13.1.010 Update, syngo Radiation Therapy Therapist v4.3.1_MR3 Patch, syngo Radiation Therapy Oncologist v4.3.1_MR3 Patch K182050 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k182115/ 2018-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k182115-vinyl-patient-examination-gloves-fda-510k.jpg K182115 - Vinyl Patient Examination Gloves K182115 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Pingan Medical Products Co., Ltd.. Cleared Oct 2018. https://www.510kdatabase.net/k182539/ 2018-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k182539-2mp-color-lcd-monitor-cl-r211-fda-510k.jpg K182539 - 2MP Color LCD Monitor CL-R211 K182539 is a FDA 510(k) cleared radiology medical device. Manufacturer: Jvckenwood Corporation. Cleared Oct 2018. https://www.510kdatabase.net/k171696/ 2018-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k171696-noxboxi-nitric-oxide-delivery-system-fda-510k.jpg K171696 - NOxBOXi Nitric Oxide Delivery System K171696 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Praxair Distribution, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k173642/ 2018-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k173642-klockner-surgical-box-fda-510k.jpg K173642 - KLOCKNER SURGICAL BOX K173642 is a FDA 510(k) cleared general hospital medical device. Manufacturer: SOADCO, S.L.. Cleared Oct 2018. https://www.510kdatabase.net/k181081/ 2018-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k181081-infrared-ear-thermometer-fda-510k.jpg K181081 - Infrared Ear Thermometer K181081 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Joytech Healthcare Co. , Ltd.. Cleared Oct 2018. https://www.510kdatabase.net/k181867/ 2018-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k181867-deka-smartxide2-trio-fda-510k.jpg K181867 - Deka Smartxide2 Trio K181867 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: El.En Electronic Engineering Spa. Cleared Oct 2018. https://www.510kdatabase.net/k181885/ 2018-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k181885-voyant-system-fda-510k.jpg K181885 - Voyant System K181885 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Viseon, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k182051/ 2018-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k182051-fujifilm-duodenoscope-model-fda-510k.jpg K182051 - FUJIFILM Duodenoscope Model K182051 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fujifilm Corporation. Cleared Oct 2018. https://www.510kdatabase.net/k173716/ 2018-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k173716-mps2-myocardial-protection-system-fda-510k.jpg K173716 - MPS2 Myocardial Protection System Console K173716 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quest Medical, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k181445/ 2018-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k181445-amsure-hydrophilic-intermittent-catheter-fda-510k.jpg K181445 - AMSure Hydrophilic Intermittent Catheter K181445 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Amsino International, Inc.. Cleared Oct 2018. https://www.510kdatabase.net/k181622/ 2018-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k181622-stratamr-guider-tool-fda-510k.jpg K181622 - StrataMR guider tool K181622 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Neurosurgery. Cleared Oct 2018. https://www.510kdatabase.net/k172957/ 2018-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k172957-kawasumi-laboratories-blood-drawing-fda-510k.jpg K172957 - Kawasumi Laboratories Blood Drawing Kit (BDK) System K172957 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Kawasumi Laboratories, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k173872/ 2018-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k173872-fibricheck-fda-510k.jpg K173872 - FibriCheck K173872 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Qompium NV. Cleared Sep 2018. https://www.510kdatabase.net/k180041/ 2018-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k180041-biocode-gastrointestinal-pathogen-fda-510k.jpg K180041 - BioCode Gastrointestinal Pathogen Panel (GPP) K180041 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Applied BioCode, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k180068/ 2018-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k180068-orise-gel-fda-510k.jpg K180068 - ORISE Gel K180068 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific. Cleared Sep 2018. https://www.510kdatabase.net/k180216/ 2018-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k180216-seidmon-antegrade-aq-stent-set-fda-510k.jpg K180216 - Seidmon Antegrade AQ Stent Set K180216 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Sep 2018. https://www.510kdatabase.net/k180241/ 2018-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k180241-orthocaps-twinaligner-fda-510k.jpg K180241 - Orthocaps Twinaligner K180241 is a FDA 510(k) cleared dental medical device. Manufacturer: Ortho Caps GmbH. Cleared Sep 2018. https://www.510kdatabase.net/k180964/ 2018-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k180964-endoscope-sterilization-tray-fda-510k.jpg K180964 - Endoscope Sterilization Tray K180964 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k180973/ 2018-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k180973-libertas-hip-replacement-system-fda-510k.jpg K180973 - Libertas Hip Replacement System K180973 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Maxx Orthopedics, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k180998/ 2018-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k180998-biohorizons-cadcam-bars-fda-510k.jpg K180998 - BioHorizons CAD/CAM Bars K180998 is a FDA 510(k) cleared dental medical device. Manufacturer: BioHorizons Implant Systems, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k181088/ 2018-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k181088-tsp-crosser-transseptal-access-system-fda-510k.jpg K181088 - TSP Crosser Transseptal Access System K181088 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Transseptal Solutions , Ltd.. Cleared Sep 2018. https://www.510kdatabase.net/k181124/ 2018-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k181124-acessa-provu-system-fda-510k.jpg K181124 - Acessa ProVu System K181124 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Acessa Health, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k181277/ 2018-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k181277-e-cube-12-fda-510k.jpg K181277 - E-CUBE 12 K181277 is a FDA 510(k) cleared radiology medical device. Manufacturer: Alpinion Medical Systems Co., Ltd.. Cleared Sep 2018. https://www.510kdatabase.net/k181476/ 2018-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k181476-primebond-active-universal-adhesive-fda-510k.jpg K181476 - Prime&Bond active Universal Adhesive K181476 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona. Cleared Sep 2018. https://www.510kdatabase.net/k181652/ 2018-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k181652-coated-vicryl-plus-antibacterial-fda-510k.jpg K181652 - Coated Vicryl Plus Antibacterial (Polyglactin 910) Absorable Suture K181652 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k181746/ 2018-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k181746-microraptor-knotless-suture-anchor-fda-510k.jpg K181746 - MICRORAPTOR Knotless Suture Anchor K181746 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith and Nephew, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k181771/ 2018-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k181771-righteye-vision-system-fda-510k.jpg K181771 - RightEye Vision System K181771 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Righteye, LLC. Cleared Sep 2018. https://www.510kdatabase.net/k181794/ 2018-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k181794-truliant-porous-femoral-components-fda-510k.jpg K181794 - Truliant Porous Femoral Components K181794 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k182039/ 2018-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k182039-arthrex-univers-revers-porous-coated-fda-510k.jpg K182039 - Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay K182039 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k182376/ 2018-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k182376-harmony-fda-510k.jpg K182376 - Harmony K182376 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Topcon Medical Systems, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k182415/ 2018-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k182415-alphenix-infx-8000fb-v80-fda-510k.jpg K182415 - Alphenix, INFX-8000F/B, V8.0 K182415 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Sep 2018. https://www.510kdatabase.net/den170080/ 2018-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/den170080-adaptive-biotechnologies-clonoseq-assay-fda-510k.jpg DEN170080 - Adaptive Biotechnologies clonoSEQ Assay DEN170080 is a FDA 510(k) cleared pathology medical device. Manufacturer: Adaptive Biotechnologies Corporation. Cleared Sep 2018. https://www.510kdatabase.net/k173833/ 2018-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k173833-crp-vario-fda-510k.jpg K173833 - CRP Vario K173833 is a FDA 510(k) cleared chemistry medical device. Manufacturer: SENTINEL CH. SpA. Cleared Sep 2018. https://www.510kdatabase.net/k181021/ 2018-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k181021-embocube-embolization-gelatin-fda-510k.jpg K181021 - EmboCube Embolization Gelatin K181021 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biosphere Medical, S.A.. Cleared Sep 2018. https://www.510kdatabase.net/k181075/ 2018-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k181075-pureset-tray-fda-510k.jpg K181075 - PureSet Tray K181075 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Nobel Biocare AB. Cleared Sep 2018. https://www.510kdatabase.net/k181397/ 2018-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k181397-dualx-fda-510k.jpg K181397 - DualX K181397 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Innovasive, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k181608/ 2018-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k181608-disposable-standard-clamp-fda-510k.jpg K181608 - Disposable Standard Clamp K181608 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Standard Bariatrics. Cleared Sep 2018. https://www.510kdatabase.net/k181742/ 2018-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k181742-reunion-reversible-fracture-system-rfx-fda-510k.jpg K181742 - ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Arthroplasty System (TSA) K181742 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker GmbH. Cleared Sep 2018. https://www.510kdatabase.net/k181975/ 2018-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k181975-thermo-scientific-oxoid-fda-510k.jpg K181975 - Thermo Scientific Oxoid Meropenem/Vaborbactam Disc (30µg) MEV30 K181975 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Oxoid Limited (Part of Thermo Fisher Scientific). Cleared Sep 2018. https://www.510kdatabase.net/k182370/ 2018-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k182370-acculoc-total-knee-system-fda-510k.jpg K182370 - Acculoc Total Knee System K182370 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Rootloc Co., Ltd.. Cleared Sep 2018. https://www.510kdatabase.net/k182377/ 2018-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k182377-carboclear-pedicle-screw-system-fda-510k.jpg K182377 - CarboClear® Pedicle Screw System K182377 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: CarboFix Orthopedics , Ltd.. Cleared Sep 2018. https://www.510kdatabase.net/k182402/ 2018-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k182402-colink-view-plating-system-fda-510k.jpg K182402 - CoLink View Plating System K182402 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: In2bones USA, LLC. Cleared Sep 2018. https://www.510kdatabase.net/k180340/ 2018-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k180340-stat-profile-prime-plus-analyzer-system-fda-510k.jpg K180340 - Stat Profile Prime Plus Analyzer System K180340 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Nova Biomedical Corporation. Cleared Sep 2018. https://www.510kdatabase.net/k180803/ 2018-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k180803-beautibond-universal-fda-510k.jpg K180803 - BeautiBond Universal K180803 is a FDA 510(k) cleared dental medical device. Manufacturer: Shofu Dental Corporation. Cleared Sep 2018. https://www.510kdatabase.net/k181066/ 2018-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k181066-powder-free-nitrile-examination-glove-fda-510k.jpg K181066 - Powder Free Nitrile Examination Glove (Blue) with Low Dermatitis claim and with tested for Use with Chemotherapy Drugs Claims K181066 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Eco Medi Glove Sdn. Bhd.. Cleared Sep 2018. https://www.510kdatabase.net/k181563/ 2018-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k181563-the-arterial-wand-safety-introducer-fda-510k.jpg K181563 - The ARTERIAL WAND Safety Introducer with Arterial Catheter made of ChronoFlex C with BioGUARD Technology K181563 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Access Scientific, LLC. Cleared Sep 2018. https://www.510kdatabase.net/k181591/ 2018-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k181591-fixated-asfora-bullet-cage-fabc-fda-510k.jpg K181591 - Fixated Asfora BULLET CAGE® (FABC) K181591 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medical Designs, LLC. Cleared Sep 2018. https://www.510kdatabase.net/k181707/ 2018-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k181707-everyway-wireless-tens-ems-unit-fda-510k.jpg K181707 - Everyway Wireless TENS & EMS Unit K181707 is a FDA 510(k) cleared neurology medical device. Manufacturer: Everyway Medical Instruments Co.,Ltd. Cleared Sep 2018. https://www.510kdatabase.net/k181991/ 2018-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k181991-nxstage-connected-health-system-fda-510k.jpg K181991 - NxStage Connected Health System K181991 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Nxstage Medical, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k182315/ 2018-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k182315-magic-torque-dlvr-guidewire-fda-510k.jpg K182315 - Magic Torque DLVR Guidewire K182315 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Sep 2018. https://www.510kdatabase.net/k182325/ 2018-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k182325-inmode-rf-system-fda-510k.jpg K182325 - InMode RF System K182325 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Inmode MD , Ltd.. Cleared Sep 2018. https://www.510kdatabase.net/k182357/ 2018-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k182357-hardydisk-ast-eravacycline-20g-erv20-fda-510k.jpg K182357 - HardyDisk AST Eravacycline 20µg (ERV20) K182357 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Hardy Diagnostics. Cleared Sep 2018. https://www.510kdatabase.net/k173127/ 2018-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k173127-skyla-hi-hemoglobin-a1c-system-skyla-fda-510k.jpg K173127 - skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit) K173127 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Skyla Corporation H.S.P.B. Cleared Sep 2018. https://www.510kdatabase.net/k181424/ 2018-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k181424-pedia-fda-510k.jpg K181424 - PeDIA K181424 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Pedia, LLC. Cleared Sep 2018. https://www.510kdatabase.net/k181692/ 2018-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k181692-5cm-tag-applicator-7cm-tag-applicator-fda-510k.jpg K181692 - 5cm Tag Applicator, 7cm Tag Applicator, 10 cm Tag Applicator, 5 cm Tag Applicator (10 pack), 7cm Tag Applicator (10 pack), 10cm Tag Applicator (10 pack), LOCalizer Surgical Probe, LOCalizer Surgical Probe (5 pack) K181692 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Health Beacons, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k181773/ 2018-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k181773-synapse-3d-optional-tools-fda-510k.jpg K181773 - Synapse 3D Optional Tools K181773 is a FDA 510(k) cleared radiology medical device. Manufacturer: Fujifilm Corporation. Cleared Sep 2018. https://www.510kdatabase.net/k181795/ 2018-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k181795-ast-model-ma012-and-ms019-rehab-fda-510k.jpg K181795 - AST Model MA012 and MS019 Rehab Wheelchair K181795 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Sichuan Ast Medical Equipment Co., Ltd.. Cleared Sep 2018. https://www.510kdatabase.net/k181904/ 2018-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k181904-5-fr-dual-lumen-piper-picc-fda-510k.jpg K181904 - 5 FR Dual Lumen Piper PICC K181904 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Piper Access, LLC. Cleared Sep 2018. https://www.510kdatabase.net/k181980/ 2018-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k181980-osseoscrew-system-fda-510k.jpg K181980 - OsseoScrew System K181980 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k182290/ 2018-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k182290-ibm-iconnect-access-fda-510k.jpg K182290 - IBM iConnect Access K182290 is a FDA 510(k) cleared radiology medical device. Manufacturer: Merge Healthcare Incorporated. Cleared Sep 2018. https://www.510kdatabase.net/k182335/ 2018-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k182335-cpx-4-breast-tissue-expander-with-fda-510k.jpg K182335 - CPX 4 Breast Tissue Expander with Smooth Surface K182335 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Mentor Worldwide, LLC. Cleared Sep 2018. https://www.510kdatabase.net/k180714/ 2018-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k180714-probe-covers-for-thermometers-fda-510k.jpg K180714 - Probe Covers for Thermometers K180714 is a FDA 510(k) cleared general hospital medical device. Manufacturer: K-Jump Health Co., Ltd.. Cleared Sep 2018. https://www.510kdatabase.net/k180916/ 2018-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k180916-intuition-t1-mapping-and-t2t2-mapping-fda-510k.jpg K180916 - iNtuition-T1 Mapping and T2/T2* Mapping K180916 is a FDA 510(k) cleared radiology medical device. Manufacturer: Terarecon,Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k181366/ 2018-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k181366-redapt-porous-acetabular-shell-fda-510k.jpg K181366 - REDAPT Porous Acetabular Shell K181366 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k181611/ 2018-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k181611-comprehensive-reverse-shoulder-system-fda-510k.jpg K181611 - Comprehensive Reverse Shoulder System K181611 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet Manufacturing Corp. Cleared Sep 2018. https://www.510kdatabase.net/k182317/ 2018-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k182317-amadeo-m-dr-mini-amadeo-m-ax-mini-fda-510k.jpg K182317 - AMADEO M-DR mini, AMADEO M-AX mini K182317 is a FDA 510(k) cleared radiology medical device. Manufacturer: Oehm Und Rehbein GmbH. Cleared Sep 2018. https://www.510kdatabase.net/k171947/ 2018-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k171947-soloassist-ii-fda-510k.jpg K171947 - SOLOASSIST II K171947 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aktormed GmbH. Cleared Sep 2018. https://www.510kdatabase.net/k172418/ 2018-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k172418-opensight-fda-510k.jpg K172418 - OpenSight K172418 is a FDA 510(k) cleared radiology medical device. Manufacturer: Novarad Corporation. Cleared Sep 2018. https://www.510kdatabase.net/k173960/ 2018-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k173960-depuy-corail-amt-hip-prosthesis-fda-510k.jpg K173960 - DePuy Corail AMT Hip Prosthesis K173960 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy France S.A.S.. Cleared Sep 2018. https://www.510kdatabase.net/k180029/ 2018-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k180029-malecot-nephrostomy-catheterstent-set-fda-510k.jpg K180029 - Malecot Nephrostomy Catheter/Stent Set K180029 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Sep 2018. https://www.510kdatabase.net/k180144/ 2018-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k180144-agile-esophageal-stent-system-fda-510k.jpg K180144 - Agile Esophageal Stent System K180144 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Sep 2018. https://www.510kdatabase.net/k180338/ 2018-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k180338-cellulize-fda-510k.jpg K180338 - Cellulize K180338 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ward Photonics, LLC. Cleared Sep 2018. https://www.510kdatabase.net/k180489/ 2018-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k180489-tevadaptor-closed-drug-reconstitution-fda-510k.jpg K180489 - TEVADAPTOR Closed Drug Reconstitution and Transfer System K180489 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Teva Medical Ltd., Migada Plant. Cleared Sep 2018. https://www.510kdatabase.net/k181006/ 2018-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k181006-bb-613-watch-oximeter-fda-510k.jpg K181006 - BB-613 Watch Oximeter K181006 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Bio-Beat Technologies , Ltd.. Cleared Sep 2018. https://www.510kdatabase.net/k181034/ 2018-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k181034-pocket-colposcope-system-fda-510k.jpg K181034 - Pocket Colposcope System K181034 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Hadleigh Health Technologies, LLC. Cleared Sep 2018. https://www.510kdatabase.net/k181200/ 2018-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k181200-aeromini-tracheobronchial-stent-system-fda-510k.jpg K181200 - AEROmini Tracheobronchial Stent System K181200 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k181616/ 2018-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k181616-psm-3-way-silicone-foley-catheter-fda-510k.jpg K181616 - PSM 3-Way Silicone Foley Catheter K181616 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Pathway, LLC. Cleared Sep 2018. https://www.510kdatabase.net/k181665/ 2018-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k181665-bd-phoenix-automated-microbiology-fda-510k.jpg K181665 - BD Phoenix Automated Microbiology System - BD Phoenix CPO detect - GN K181665 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson and Company. Cleared Sep 2018. https://www.510kdatabase.net/k181702/ 2018-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k181702-tranquil-l-interbody-system-fda-510k.jpg K181702 - Tranquil-L Interbody System K181702 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nexus Spine, LLC. Cleared Sep 2018. https://www.510kdatabase.net/k181769/ 2018-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k181769-arthrex-fibertak-suture-anchor-fda-510k.jpg K181769 - Arthrex FiberTak Suture Anchor K181769 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k181789/ 2018-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k181789-verisuite-fda-510k.jpg K181789 - VeriSuite K181789 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medcom GmbH. Cleared Sep 2018. https://www.510kdatabase.net/k181926/ 2018-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k181926-invivo-web-viewer-fda-510k.jpg K181926 - InVivo Web Viewer K181926 is a FDA 510(k) cleared radiology medical device. Manufacturer: Anatomage, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k182043/ 2018-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k182043-single-use-medical-poly-vinyl-chloride-fda-510k.jpg K182043 - Single-use medical poly (vinyl chloride) examination glove (Clear, Non-Colored) K182043 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hebei Titans Hongsen Medical Technology Co., Ltd.. Cleared Sep 2018. https://www.510kdatabase.net/k182258/ 2018-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k182258-aquashield-system-co2-fda-510k.jpg K182258 - AquaShield System CO2 K182258 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: United States Endoscopy Group, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k182310/ 2018-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k182310-volpara-imaging-software-fda-510k.jpg K182310 - Volpara Imaging Software K182310 is a FDA 510(k) cleared radiology medical device. Manufacturer: Volpara Health Technologies Limited. Cleared Sep 2018. https://www.510kdatabase.net/k182345/ 2018-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k182345-spineology-navigation-instruments-fda-510k.jpg K182345 - Spineology Navigation Instruments K182345 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spineology, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/den070001/ 2018-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/den070001-non-variola-orthopoxvirus-real-time-fda-510k.jpg DEN070001 - NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR PRIMER AND PROBE SET DEN070001 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Centers For Disease Control and Prevention. Cleared Sep 2018. https://www.510kdatabase.net/k173898/ 2018-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k173898-microport-orthopedics-total-hip-fda-510k.jpg K173898 - MicroPort Orthopedics Total Hip Systems MR Labeling K173898 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Microport Orthopedics Inc. (Mpo). Cleared Sep 2018. https://www.510kdatabase.net/k180366/ 2018-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k180366-endotool-subq-fda-510k.jpg K180366 - EndoTool SubQ K180366 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Al Pacheco and Associates. Cleared Sep 2018. https://www.510kdatabase.net/k181199/ 2018-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k181199-katalyst-mark-1-muscle-stimulation-fda-510k.jpg K181199 - Katalyst Mark 1 Muscle Stimulation System Model 2 K181199 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Katalyst, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k181205/ 2018-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k181205-non-variola-orthopoxvirus-real-time-fda-510k.jpg K181205 - Non-variola Orthopoxvirus Real-time PCR Primer and Probe Set K181205 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Centers For Disease Control and Prevention. Cleared Sep 2018. https://www.510kdatabase.net/k181305/ 2018-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k181305-oraltox-oral-fluid-drug-test-fda-510k.jpg K181305 - OralTox Oral fluid Drug Test K181305 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Premier Biotech, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k181420/ 2018-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k181420-aequalis-flex-revive-shoulder-system-fda-510k.jpg K181420 - Aequalis Flex Revive Shoulder System K181420 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tornier, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k181726/ 2018-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k181726-medline-patient-cables-and-lead-wires-fda-510k.jpg K181726 - Medline Patient Cables and Lead Wires K181726 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medline Industries, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k181783/ 2018-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k181783-logiq-p9-fda-510k.jpg K181783 - LOGIQ P9 K181783 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Sep 2018. https://www.510kdatabase.net/k181995/ 2018-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k181995-chiral-surgical-pedicle-screw-system-fda-510k.jpg K181995 - Chiral Surgical Pedicle Screw System K181995 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Chiral Surgical. Cleared Sep 2018. https://www.510kdatabase.net/k182340/ 2018-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k182340-nico-myriad-fda-510k.jpg K182340 - NICO Myriad K182340 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Nico Corporation. Cleared Sep 2018. https://www.510kdatabase.net/k173141/ 2018-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k173141-csm-submerged3-l-implant-system-fda-510k.jpg K173141 - CSM Submerged3-L Implant System K173141 is a FDA 510(k) cleared dental medical device. Manufacturer: Csm Implant. Cleared Sep 2018. https://www.510kdatabase.net/k173982/ 2018-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k173982-fortify-corpectomy-spacers-fda-510k.jpg K173982 - FORTIFY Corpectomy Spacers K173982 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k180781/ 2018-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k180781-bard-vertus-foley-catheter-fda-510k.jpg K180781 - Bard Vertus Foley Catheter K180781 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k180893/ 2018-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k180893-ihm-technology-bandage-fda-510k.jpg K180893 - IHM Technology Bandage K180893 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Protege Biomedical. Cleared Sep 2018. https://www.510kdatabase.net/k180894/ 2018-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k180894-magnetic-surgical-system-fda-510k.jpg K180894 - Magnetic Surgical System K180894 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Levita Magnetics International Corp. Cleared Sep 2018. https://www.510kdatabase.net/k180981/ 2018-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k180981-stimulator-kit-trial-kit-spare-lead-fda-510k.jpg K180981 - Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit K180981 is a FDA 510(k) cleared neurology medical device. Manufacturer: Stimwave Technologies Incorporated. Cleared Sep 2018. https://www.510kdatabase.net/k181229/ 2018-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k181229-tirbolox-c-cervical-ibfd-fda-510k.jpg K181229 - TirboLOX-C Cervical IBFD K181229 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Captiva Spine, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k181328/ 2018-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k181328-t2-stratosphere-expandable-corpectomy-fda-510k.jpg K181328 - T2 STRATOSPHERE™ Expandable Corpectomy System K181328 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k181349/ 2018-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k181349-vexillum-olifilcon-b-with-tangible-fda-510k.jpg K181349 - Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens K181349 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Visco Vision, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k181449/ 2018-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k181449-ortoma-treatment-solution-ots-fda-510k.jpg K181449 - Ortoma Treatment Solution - OTS K181449 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ortoma AB. Cleared Sep 2018. https://www.510kdatabase.net/k181734/ 2018-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k181734-beurer-ipl-8500-device-ipl-velvetskin-fda-510k.jpg K181734 - Beurer IPL 8500 device/ IPL VelvetSkin Pro K181734 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Home Well Trading, Ltd.. Cleared Sep 2018. https://www.510kdatabase.net/k182080/ 2018-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k182080-scope-antifogging-system-fda-510k.jpg K182080 - Scope Antifogging System K182080 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Xodus Medical, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k182286/ 2018-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k182286-ohcare-lite-smart-blood-glucose-fda-510k.jpg K182286 - Oh'Care Lite Smart Blood Glucose Monitoring System K182286 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Osang Healthcare Co. , Ltd.. Cleared Sep 2018. https://www.510kdatabase.net/k171904/ 2018-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k171904-tandry-locking-plate-system-fda-510k.jpg K171904 - Tandry Locking Plate System K171904 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Microware Precision Co., Ltd.. Cleared Sep 2018. https://www.510kdatabase.net/k173830/ 2018-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k173830-mac-vu360-resting-ecg-analysis-system-fda-510k.jpg K173830 - MAC VU360 Resting ECG Analysis System K173830 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k181233/ 2018-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k181233-elecsys-ft4-iii-fda-510k.jpg K181233 - Elecsys FT4 III K181233 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Sep 2018. https://www.510kdatabase.net/k181320/ 2018-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k181320-caprolon-fda-510k.jpg K181320 - Caprolon K181320 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Resorba Medical GmbH. Cleared Sep 2018. https://www.510kdatabase.net/k181337/ 2018-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k181337-sypher-spacer-system-fda-510k.jpg K181337 - Sypher Spacer System K181337 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biogennix, LLC. Cleared Sep 2018. https://www.510kdatabase.net/k181390/ 2018-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k181390-response-spine-system-response-5560-fda-510k.jpg K181390 - Response Spine System, Response 5.5/6.0 Spine System, Response 4.5/5.0 Spine System K181390 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: OrthoPediatrics Corp.. Cleared Sep 2018. https://www.510kdatabase.net/k181620/ 2018-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k181620-endoscopic-linear-cutting-staplers-and-fda-510k.jpg K181620 - Endoscopic Linear Cutting Staplers and Loading Units for Single Use K181620 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ezisurg (Suzhou) Medical Co., Ltd.. Cleared Sep 2018. https://www.510kdatabase.net/k181653/ 2018-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k181653-ethicon-circular-stapler-ethicon-fda-510k.jpg K181653 - Ethicon Circular Stapler, Ethicon Circular Stapler -XL Sealed K181653 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon Endo-Surgery, LLC. Cleared Sep 2018. https://www.510kdatabase.net/k182157/ 2018-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k182157-biosign-flu-ab-fda-510k.jpg K182157 - BioSign Flu A+B K182157 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Princeton BioMeditech Corp.. Cleared Sep 2018. https://www.510kdatabase.net/k182243/ 2018-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k182243-the-cvc-wand-safety-introducer-with-fda-510k.jpg K182243 - The CVC WAND Safety Introducer with Valved Peelable Sheath K182243 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Access Scientific, LLC. Cleared Sep 2018. https://www.510kdatabase.net/k173871/ 2018-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k173871-callispheres-embolic-microspheres-fda-510k.jpg K173871 - CalliSpheres Embolic Microspheres, 8Spheres Embolic Microspheres K173871 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Suzhou Hengrui Callisyn Biomedical Co., Ltd.. Cleared Sep 2018. https://www.510kdatabase.net/k180933/ 2018-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k180933-dentek-ultimate-dental-guard-fda-510k.jpg K180933 - DenTek Ultimate Dental Guard K180933 is a FDA 510(k) cleared dental medical device. Manufacturer: Medtech Products, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k181632/ 2018-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k181632-venacure-1470-pro-fda-510k.jpg K181632 - Venacure 1470 Pro K181632 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Quanta System Spa. Cleared Sep 2018. https://www.510kdatabase.net/k181721/ 2018-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k181721-ceracell-ortho-foam-fda-510k.jpg K181721 - Ceracell Ortho Foam K181721 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Curasan AG. Cleared Sep 2018. https://www.510kdatabase.net/k182260/ 2018-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k182260-palacos-mv-fda-510k.jpg K182260 - PALACOS MV K182260 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Heraeus Medical GmbH. Cleared Sep 2018. https://www.510kdatabase.net/k181102/ 2018-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k181102-thermacare-quick-therapy-tens-fda-510k.jpg K181102 - ThermaCare Quick Therapy TENS K181102 is a FDA 510(k) cleared neurology medical device. Manufacturer: Pfizer, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k173676/ 2018-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k173676-a-fit-fda-510k.jpg K173676 - A-FIT K173676 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Hironic Co., Ltd.. Cleared Sep 2018. https://www.510kdatabase.net/k173827/ 2018-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k173827-lightscalpel-fda-510k.jpg K173827 - LightScalpel K173827 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lightscalpel, LLC. Cleared Sep 2018. https://www.510kdatabase.net/k173910/ 2018-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k173910-impress-sfs-system-fda-510k.jpg K173910 - Impress SFS System K173910 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Cable Fix Medical, LLC. Cleared Sep 2018. https://www.510kdatabase.net/k173926/ 2018-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k173926-doradonova-mr3t-fda-510k.jpg K173926 - DORADOnova MR3T K173926 is a FDA 510(k) cleared radiology medical device. Manufacturer: Lap GmbH Laser Applikationen. Cleared Sep 2018. https://www.510kdatabase.net/k180182/ 2018-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k180182-dual-lumen-ureteral-access-catheter-fda-510k.jpg K180182 - Dual Lumen Ureteral Access Catheter, Flexi-Tip Dual Lumen Ureteral Access Catheter K180182 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Sep 2018. https://www.510kdatabase.net/k180369/ 2018-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k180369-intracept-intraosseous-nerve-ablation-fda-510k.jpg K180369 - Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe) K180369 is a FDA 510(k) cleared neurology medical device. Manufacturer: Relievant Medsystems. Cleared Sep 2018. https://www.510kdatabase.net/k180871/ 2018-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k180871-portable-nebulizer-fda-510k.jpg K180871 - Portable Nebulizer K180871 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Microbase Technology Corporation. Cleared Sep 2018. https://www.510kdatabase.net/k180875/ 2018-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k180875-poly-rejuv-fda-510k.jpg K180875 - POLY REJUV K180875 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medtek Skincare, LLC. Cleared Sep 2018. https://www.510kdatabase.net/k181598/ 2018-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k181598-prime-e-class-xlpe-liner-fda-510k.jpg K181598 - Prime E-CLASS XLPE Liner K181598 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Microport Orthopedics, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k181874/ 2018-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k181874-mx40-mobile-digital-x-ray-system-fda-510k.jpg K181874 - MX40 Mobile Digital X-ray System K181874 is a FDA 510(k) cleared radiology medical device. Manufacturer: Huestis Machine Corporation. Cleared Sep 2018. https://www.510kdatabase.net/k182213/ 2018-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k182213-qt-ultrasound-breast-scanner-1-fda-510k.jpg K182213 - QT Ultrasound Breast Scanner - 1 K182213 is a FDA 510(k) cleared radiology medical device. Manufacturer: Qt Ultrasound, LLC. Cleared Sep 2018. https://www.510kdatabase.net/k182214/ 2018-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k182214-dizzydoctor-system-100-fda-510k.jpg K182214 - DizzyDoctor System 1.0.0 K182214 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Dizzydoctor Systems, LLC. Cleared Sep 2018. https://www.510kdatabase.net/k182223/ 2018-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k182223-aquilion-one-self-propelled-scan-base-fda-510k.jpg K182223 - Aquilion ONE Self-Propelled Scan Base Kit for IVR-CT, CGBA-034A K182223 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems, USA. Cleared Sep 2018. https://www.510kdatabase.net/k172450/ 2018-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k172450-tens-device-headaterm-eespress-fda-510k.jpg K172450 - TENS device-HeadaTerm, eEspress K172450 is a FDA 510(k) cleared neurology medical device. Manufacturer: Wat Medical Technology (Ningbo) Co., Ltd.. Cleared Sep 2018. https://www.510kdatabase.net/k173933/ 2018-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k173933-sorrento-bioglass-bone-graft-substitute-fda-510k.jpg K173933 - Sorrento Bioglass Bone Graft Substitute K173933 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Xenco Medical, LLC. Cleared Sep 2018. https://www.510kdatabase.net/k180053/ 2018-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k180053-sof-flex-ureteral-stent-set-fda-510k.jpg K180053 - Sof-Flex Ureteral Stent Set K180053 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Sep 2018. https://www.510kdatabase.net/k180215/ 2018-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k180215-dyna-link-elite-stand-alone-anterior-fda-510k.jpg K180215 - DYNA-LINK ELITE Stand-Alone Anterior Lumbar System K180215 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k181000/ 2018-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k181000-selectflex-072-neurovascular-access-fda-510k.jpg K181000 - SelectFlex 072 Neurovascular Access System K181000 is a FDA 510(k) cleared neurology medical device. Manufacturer: Q'Apel. Cleared Sep 2018. https://www.510kdatabase.net/k181236/ 2018-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k181236-hysil-impression-materials-fda-510k.jpg K181236 - HySil Impression Materials K181236 is a FDA 510(k) cleared dental medical device. Manufacturer: Osstem Implant Co., Ltd.. Cleared Sep 2018. https://www.510kdatabase.net/k181241/ 2018-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k181241-kls-martin-individual-patient-fda-510k.jpg K181241 - KLS Martin Individual Patient Solutions (IPS) Planning System K181241 is a FDA 510(k) cleared dental medical device. Manufacturer: KLS-Martin L.P.. Cleared Sep 2018. https://www.510kdatabase.net/k181576/ 2018-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k181576-planmeca-viso-fda-510k.jpg K181576 - Planmeca Viso K181576 is a FDA 510(k) cleared radiology medical device. Manufacturer: Planmeca Oy. Cleared Sep 2018. https://www.510kdatabase.net/k181594/ 2018-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k181594-spectralis-hraoct-and-variants-with-fda-510k.jpg K181594 - Spectralis HRA+OCT and variants with OCT Angiography Module K181594 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Heidelberg Engineering GmbH. Cleared Sep 2018. https://www.510kdatabase.net/k181821/ 2018-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k181821-moss-vrs-spinal-system-fda-510k.jpg K181821 - MOSS VRS Spinal System K181821 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biedermann Motech GmbH & Co. KG. Cleared Sep 2018. https://www.510kdatabase.net/k181889/ 2018-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k181889-mts-penicillin-0002-32-gml-fda-510k.jpg K181889 - MTS Penicillin 0.002- 32 µg/mL K181889 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Liofilchem S. R. L.. Cleared Sep 2018. https://www.510kdatabase.net/k182206/ 2018-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k182206-rix70-dc-fda-510k.jpg K182206 - RiX70 DC K182206 is a FDA 510(k) cleared radiology medical device. Manufacturer: Trident S.R.L. Cleared Sep 2018. https://www.510kdatabase.net/k182275/ 2018-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k182275-seal-single-use-biopsy-valve-fda-510k.jpg K182275 - Seal Single Use Biopsy Valve K182275 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Sep 2018. https://www.510kdatabase.net/k173424/ 2018-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k173424-biosphere-flex-fda-510k.jpg K173424 - BioSphere Flex K173424 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synergy Biomedical. Cleared Sep 2018. https://www.510kdatabase.net/k181255/ 2018-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k181255-prodense-bone-graft-substitute-fda-510k.jpg K181255 - PRODENSE Bone Graft Substitute K181255 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Sep 2018. https://www.510kdatabase.net/k181748/ 2018-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k181748-magnesium-fda-510k.jpg K181748 - Magnesium K181748 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Sep 2018. https://www.510kdatabase.net/k171532/ 2018-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k171532-trubase-s-fda-510k.jpg K171532 - TruBase S K171532 is a FDA 510(k) cleared dental medical device. Manufacturer: Truabutment, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k173822/ 2018-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k173822-anchor-tissue-retrieval-system-by-conmed-fda-510k.jpg K173822 - Anchor Tissue Retrieval System by CONMED K173822 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Conmed Corporation. Cleared Sep 2018. https://www.510kdatabase.net/k181380/ 2018-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k181380-lnk-lumbar-interbody-fusion-cage-system-fda-510k.jpg K181380 - LnK Lumbar Interbody Fusion Cage System K181380 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: L & K Biomed Co., Ltd.. Cleared Sep 2018. https://www.510kdatabase.net/k181504/ 2018-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k181504-stryker-pediatric-mandibular-fda-510k.jpg K181504 - Stryker Pediatric Mandibular Distractor 2 K181504 is a FDA 510(k) cleared dental medical device. Manufacturer: Stryker. Cleared Sep 2018. https://www.510kdatabase.net/k181568/ 2018-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k181568-ipl-salon-hair-reduction-system-fda-510k.jpg K181568 - IPL Salon Hair Reduction System K181568 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medical Device Branch of Zhangzhou Easepal Industrial Co.,Lt. Cleared Sep 2018. https://www.510kdatabase.net/k181655/ 2018-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k181655-renovis-s180-lateral-lumbar-interbody-fda-510k.jpg K181655 - Renovis S180 Lateral Lumbar Interbody Fusion System K181655 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Renovis Surgical Technologies. Cleared Sep 2018. https://www.510kdatabase.net/k182196/ 2018-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k182196-cardiart-electronic-stethoscope-model-fda-510k.jpg K182196 - Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth K182196 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Imediplus, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k182226/ 2018-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k182226-airstrip-rpm-invisionheart-adapter-fda-510k.jpg K182226 - AirStrip RPM InvisionHeart Adapter K182226 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Airstrip Technologies, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k182232/ 2018-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k182232-octane-mechanical-thrombectomy-system-fda-510k.jpg K182232 - Octane Mechanical Thrombectomy System K182232 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vascular Solutions, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/den180042/ 2018-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/den180042-irregular-rhythm-notification-feature-fda-510k.jpg DEN180042 - Irregular Rhythm Notification Feature DEN180042 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Apple, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/den180044/ 2018-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/den180044-ecg-app-fda-510k.jpg DEN180044 - ECG App DEN180044 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Apple, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k173941/ 2018-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k173941-intellispace-perinatal-revk00-fda-510k.jpg K173941 - IntelliSpace Perinatal Rev.K.00 K173941 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Philips Medizin Systeme Boeblingen GmbH. Cleared Sep 2018. https://www.510kdatabase.net/k181078/ 2018-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k181078-the-sex-gel-fda-510k.jpg K181078 - The Sex Gel K181078 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Necessaire, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k181211/ 2018-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k181211-human-tecar-hcr-1002-fda-510k.jpg K181211 - Human Tecar HCR 1002 K181211 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Unibell S.R.L. Cleared Sep 2018. https://www.510kdatabase.net/k181415/ 2018-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k181415-xidf-aws801-angio-workstation-alphenix-fda-510k.jpg K181415 - XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0 K181415 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Sep 2018. https://www.510kdatabase.net/k181455/ 2018-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k181455-prosun-sunlamp-products-luxura-sunlamp-fda-510k.jpg K181455 - ProSun sunlamp products, Luxura sunlamp products K181455 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Prosun International, LLC. Cleared Sep 2018. https://www.510kdatabase.net/k182055/ 2018-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k182055-seculok-acp-system-fda-510k.jpg K182055 - SECULOK™ ACP System K182055 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: U&I Corporation. Cleared Sep 2018. https://www.510kdatabase.net/k170702/ 2018-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k170702-medicad-40-fda-510k.jpg K170702 - mediCAD 4.0 K170702 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medicad Hectec GmbH. Cleared Sep 2018. https://www.510kdatabase.net/k173813/ 2018-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k173813-ipl-hair-removal-device-joy-version-fda-510k.jpg K173813 - IPL Hair Removal Device Joy Version K173813 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shen Zhen Cosbeauty Co., Ltd.. Cleared Sep 2018. https://www.510kdatabase.net/k173883/ 2018-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k173883-external-fixation-system-fda-510k.jpg K173883 - External Fixation System K173883 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k180778/ 2018-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k180778-exceed-microneedling-device-fda-510k.jpg K180778 - Exceed Microneedling Device K180778 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Mt. Derm GmbH. Cleared Sep 2018. https://www.510kdatabase.net/k181061/ 2018-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k181061-corin-optimized-positioning-system-ops-fda-510k.jpg K181061 - Corin Optimized Positioning System (OPS) Femoral K181061 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corin USA. Cleared Sep 2018. https://www.510kdatabase.net/k181270/ 2018-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k181270-disposable-spo2-sensors-reusable-spo2-fda-510k.jpg K181270 - Disposable SpO2 Sensors, Reusable SpO2 Sensors K181270 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Orantech, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k181311/ 2018-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k181311-philips-hemodynamic-application-r10-fda-510k.jpg K181311 - Philips Hemodynamic Application R1.0 K181311 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Philips Medical Systems Nederlands B.V.. Cleared Sep 2018. https://www.510kdatabase.net/k181423/ 2018-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k181423-amsure-sterile-water-and-sterile-fda-510k.jpg K181423 - AMSure Sterile Water, and Sterile Normal Saline for Wound Flush K181423 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Amsino International, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k181525/ 2018-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k181525-innovance-free-ps-ag-fda-510k.jpg K181525 - INNOVANCE Free PS Ag K181525 is a FDA 510(k) cleared hematology medical device. Manufacturer: Siemens Healthcare Diagnostics Products GmbH. Cleared Sep 2018. https://www.510kdatabase.net/k181537/ 2018-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k181537-glow800-fda-510k.jpg K181537 - GLOW800 K181537 is a FDA 510(k) cleared neurology medical device. Manufacturer: Leica Microsystems (Schweiz) AG. Cleared Sep 2018. https://www.510kdatabase.net/k181688/ 2018-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k181688-r-c1-tens-and-ems-stimulator-fda-510k.jpg K181688 - R-C1 TENS and EMS Stimulator K181688 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Shenzhen Roundwhale Technology Co. , Ltd.. Cleared Sep 2018. https://www.510kdatabase.net/k181811/ 2018-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k181811-retrace-ureteral-access-sheath-fda-510k.jpg K181811 - ReTrace Ureteral Access Sheath K181811 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Coloplast A/S. Cleared Sep 2018. https://www.510kdatabase.net/k182053/ 2018-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k182053-ultravision-visual-field-clearing-system-fda-510k.jpg K182053 - Ultravision™ Visual Field Clearing System K182053 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Alesi Surgical, Ltd.. Cleared Sep 2018. https://www.510kdatabase.net/k182079/ 2018-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k182079-solstice-srs-immobilization-system-fda-510k.jpg K182079 - Solstice SRS Immobilization System K182079 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medtec Inc. Dba Civco Medical Solutions. Cleared Sep 2018. https://www.510kdatabase.net/k182144/ 2018-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k182144-bi-flex-evo-fda-510k.jpg K182144 - Bi-Flex Evo K182144 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Promepla Sam. Cleared Sep 2018. https://www.510kdatabase.net/k182147/ 2018-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k182147-ctxx85-fda-510k.jpg K182147 - CTXX85 K182147 is a FDA 510(k) cleared radiology medical device. Manufacturer: Analogic Corporation. Cleared Sep 2018. https://www.510kdatabase.net/k182148/ 2018-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k182148-silverback-gorilla-plating-system-fda-510k.jpg K182148 - SILVERBACK Gorilla Plating System K182148 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paragon 28, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k182208/ 2018-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k182208-syngovia-viewgo-version-va10a-fda-510k.jpg K182208 - syngo.via View&GO (Version VA10A) K182208 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Healthcare GmbH. Cleared Sep 2018. https://www.510kdatabase.net/k182230/ 2018-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k182230-multi-modality-viewer-fda-510k.jpg K182230 - Multi Modality Viewer K182230 is a FDA 510(k) cleared radiology medical device. Manufacturer: Vital Images, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k182263/ 2018-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k182263-retcam-3-fda-510k.jpg K182263 - RetCam 3 K182263 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Natus Medical Incorporated. Cleared Sep 2018. https://www.510kdatabase.net/k172834/ 2018-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k172834-dual-output-digital-therapy-massager-fda-510k.jpg K172834 - Dual output digital therapy massager K172834 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Osto Technology Co., Ltd.. Cleared Sep 2018. https://www.510kdatabase.net/k173893/ 2018-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k173893-trabis-fda-510k.jpg K173893 - Trabis K173893 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Coligne AG. Cleared Sep 2018. https://www.510kdatabase.net/k180465/ 2018-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k180465-provata-implant-system-fda-510k.jpg K180465 - Provata Implant System K180465 is a FDA 510(k) cleared dental medical device. Manufacturer: Southern Implants (Pty), Ltd.. Cleared Sep 2018. https://www.510kdatabase.net/k180728/ 2018-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k180728-spinal-elements-cerclage-system-fda-510k.jpg K180728 - Spinal Elements Cerclage System K180728 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinal Elements, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k181128/ 2018-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k181128-paladin-carotid-post-dilation-balloon-fda-510k.jpg K181128 - Paladin Carotid Post-dilation Balloon System with Integrated Embolic Protection (Paladin System) K181128 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Contego Medical, LLC. Cleared Sep 2018. https://www.510kdatabase.net/k181518/ 2018-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k181518-sebacia-microparticles-fda-510k.jpg K181518 - Sebacia Microparticles K181518 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sebacia, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k181558/ 2018-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k181558-sofclear-enhance-methafilcon-a-daily-fda-510k.jpg K181558 - Sofclear Enhance (methafilcon A) Daily Wear Contact Lens, Sofclear Colors (methafilcon A) Daily Wear Contact Lens, Sofclear Comfort (methafilcon A) Daily Wear Contact Lens K181558 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Gelflex Laboratories. Cleared Sep 2018. https://www.510kdatabase.net/k182153/ 2018-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k182153-ultrasound-system-sonimage-hs1-fda-510k.jpg K182153 - Ultrasound System SONIMAGE HS1 K182153 is a FDA 510(k) cleared radiology medical device. Manufacturer: Konica Minolta, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k182234/ 2018-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k182234-optima-xr240amx-fda-510k.jpg K182234 - Optima XR240amx K182234 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems, LLC. Cleared Sep 2018. https://www.510kdatabase.net/k173665/ 2018-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k173665-amsafe-sure-lok-needle-free-connector-fda-510k.jpg K173665 - AMSafe Sure-Lok Needle-Free Connector K173665 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Amsino International, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k173921/ 2018-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k173921-hd-500-video-endoscope-system-fda-510k.jpg K173921 - HD-500 Video Endoscope System K173921 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Sonoscape Medical Corp.. Cleared Sep 2018. https://www.510kdatabase.net/k173976/ 2018-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k173976-masimo-acoustic-respiration-sensors-fda-510k.jpg K173976 - Masimo Acoustic Respiration Sensors, infant and neonate K173976 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Masimo Corporation. Cleared Sep 2018. https://www.510kdatabase.net/k181662/ 2018-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k181662-iridex-trufocus-lio-premiere-fda-510k.jpg K181662 - Iridex TruFocus LIO Premiere K181662 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Iridex Corporation. Cleared Sep 2018. https://www.510kdatabase.net/k181878/ 2018-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k181878-kiierr-272-laser-kiierr-148-laser-fda-510k.jpg K181878 - Kiierr 272 Laser, Kiierr 148 Laser K181878 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Kiierr International, LLC. Cleared Sep 2018. https://www.510kdatabase.net/k182138/ 2018-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k182138-precise-treatment-system-fda-510k.jpg K182138 - Precise Treatment System K182138 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eleckta Limited. Cleared Sep 2018. https://www.510kdatabase.net/k173568/ 2018-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k173568-neobase-2-non-derivatized-msms-kit-fda-510k.jpg K173568 - NeoBase 2 Non-derivatized MSMS Kit K173568 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Wallac Oy, Subsidiary of Perkinelmer, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k173765/ 2018-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k173765-surveyor-patient-monitor-fda-510k.jpg K173765 - Surveyor Patient Monitor K173765 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Mortara Instrument, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k181249/ 2018-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k181249-eusra-rf-electrode-fda-510k.jpg K181249 - EUSRA RF Electrode K181249 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Starmed Co., Ltd.. Cleared Sep 2018. https://www.510kdatabase.net/k181314/ 2018-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k181314-intellivue-patient-monitor-mx100-fda-510k.jpg K181314 - IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream Extension K181314 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Philips Medizin Systeme Boeblingen GmbH. Cleared Sep 2018. https://www.510kdatabase.net/k181510/ 2018-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k181510-echolaser-x4-fda-510k.jpg K181510 - ECHOLASER X4 K181510 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: El.En Electronic Engineering Spa. Cleared Sep 2018. https://www.510kdatabase.net/k181532/ 2018-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k181532-exactech-alteon-monobloc-revision-stem-fda-510k.jpg K181532 - Exactech Alteon Monobloc Revision Stem K181532 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k181814/ 2018-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k181814-amsure-pre-filled-syringe-for-balloon-fda-510k.jpg K181814 - AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water K181814 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Amsino International, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k181167/ 2018-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k181167-upcera-glaze-paste-glaze-powder-and-fda-510k.jpg K181167 - Upcera Glaze Paste, Glaze Powder, and Glaze Liquid K181167 is a FDA 510(k) cleared dental medical device. Manufacturer: Liaoning Upcera Co., Ltd.. Cleared Sep 2018. https://www.510kdatabase.net/k181466/ 2018-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k181466-cadwell-zenith-system-fda-510k.jpg K181466 - Cadwell Zenith System K181466 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cadwell Industries, Inc.. Cleared Sep 2018. https://www.510kdatabase.net/k171549/ 2018-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k171549-intelligent-mesh-nebulizer-fda-510k.jpg K171549 - Intelligent Mesh Nebulizer K171549 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Qingdao Future Medical Technology Co., Ltd.. Cleared Aug 2018. https://www.510kdatabase.net/k173368/ 2018-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k173368-reusable-disposable-spo2-sensors-fda-510k.jpg K173368 - Reusable & Disposable SpO2 Sensors K173368 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Coreray Technology, Ltd.. Cleared Aug 2018. https://www.510kdatabase.net/k173477/ 2018-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k173477-chemoclave-cytotoxic-medication-fda-510k.jpg K173477 - ChemoCLAVE Cytotoxic Medication Preparation and Delivery System K173477 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Icu Medical, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k180006/ 2018-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k180006-amcad-ut-detection-22-fda-510k.jpg K180006 - AmCAD-UT Detection 2.2 K180006 is a FDA 510(k) cleared radiology medical device. Manufacturer: Amcad Biomed Corporation. Cleared Aug 2018. https://www.510kdatabase.net/k180185/ 2018-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k180185-bio-c-repair-fda-510k.jpg K180185 - BIO-C REPAIR K180185 is a FDA 510(k) cleared dental medical device. Manufacturer: Angelus Industria DE Produtos Odontologicos S/A. Cleared Aug 2018. https://www.510kdatabase.net/k180866/ 2018-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k180866-caresens-s-fit-blood-glucose-fda-510k.jpg K180866 - CareSens S Fit Blood Glucose Monitoring System K180866 is a FDA 510(k) cleared chemistry medical device. Manufacturer: I-Sens, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k181225/ 2018-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k181225-altapore-fda-510k.jpg K181225 - ALTAPORE K181225 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Baxter Healthcare Corporation. Cleared Aug 2018. https://www.510kdatabase.net/k181228/ 2018-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k181228-illuminoss-bone-stabilization-system-fda-510k.jpg K181228 - IlluminOss Bone Stabilization System K181228 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Illuminoss Medical, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k181464/ 2018-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k181464-liaison-helicobacter-antigen-liaison-fda-510k.jpg K181464 - LIAISON Helicobacter Antigen, LIAISON Helicobacter Antigen Control Set K181464 is a FDA 510(k) cleared microbiology medical device. Manufacturer: DiaSorin, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k181482/ 2018-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k181482-mytap2-fda-510k.jpg K181482 - myTAP2 K181482 is a FDA 510(k) cleared dental medical device. Manufacturer: Airway Management, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k181543/ 2018-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k181543-cure-opel-c-plate-system-fda-510k.jpg K181543 - Cure™ OPEL-C Plate System K181543 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Meditech Spine, LLC. Cleared Aug 2018. https://www.510kdatabase.net/k182107/ 2018-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k182107-carrigen-pf-fda-510k.jpg K182107 - CarriGen PF K182107 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Etex Corporation. Cleared Aug 2018. https://www.510kdatabase.net/k173042/ 2018-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k173042-fetal-maternal-monitor-models-f6-f6-fda-510k.jpg K173042 - Fetal & Maternal Monitor: Models F6, F6 Express, F9, F9 Express K173042 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Edan Instruments, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k173380/ 2018-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k173380-b-one-total-hip-system-fda-510k.jpg K173380 - b-ONE® Total Hip System K173380 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: B-One Ortho, Corp.. Cleared Aug 2018. https://www.510kdatabase.net/k173496/ 2018-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k173496-sofia-2-lyme-fia-sofia-lyme-control-set-fda-510k.jpg K173496 - Sofia 2 Lyme FIA, Sofia Lyme Control Set K173496 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Quidel Corporation. Cleared Aug 2018. https://www.510kdatabase.net/k173623/ 2018-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k173623-anchor-plate-fda-510k.jpg K173623 - Anchor plate K173623 is a FDA 510(k) cleared dental medical device. Manufacturer: Biomaterials Korea, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k173648/ 2018-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k173648-spectralis-hra-oct-and-variants-fda-510k.jpg K173648 - Spectralis HRA + OCT and variants K173648 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Heidelberg Engineering GmbH. Cleared Aug 2018. https://www.510kdatabase.net/k180536/ 2018-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k180536-neodent-implant-system-gm-line-fda-510k.jpg K180536 - Neodent Implant System – GM Line K180536 is a FDA 510(k) cleared dental medical device. Manufacturer: Jjgc Industria E Comercio DE Materiais Dentarios S.A.. Cleared Aug 2018. https://www.510kdatabase.net/k180888/ 2018-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k180888-lyft-fda-510k.jpg K180888 - LYFT K180888 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Uplevity, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k181262/ 2018-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k181262-spinejack-expansion-kit-fda-510k.jpg K181262 - SpineJack Expansion Kit K181262 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Vexim SA. Cleared Aug 2018. https://www.510kdatabase.net/k181486/ 2018-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k181486-deka-motus-ay-fda-510k.jpg K181486 - DEKA Motus AY K181486 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: El.En Electronic Engineering Spa. Cleared Aug 2018. https://www.510kdatabase.net/k181513/ 2018-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k181513-arthrex-pushlock-tenodesis-anchor-fda-510k.jpg K181513 - Arthrex PushLock Tenodesis Anchor K181513 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k181997/ 2018-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k181997-swiss-lithoclast-trilogy-fda-510k.jpg K181997 - Swiss LithoClast Trilogy K181997 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: E.M.S Electro Medical Systems S.A. Cleared Aug 2018. https://www.510kdatabase.net/k182024/ 2018-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k182024-dissecting-balloon-system-fda-510k.jpg K182024 - Dissecting Balloon System K182024 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Applied Medical Resources Corp.. Cleared Aug 2018. https://www.510kdatabase.net/k172906/ 2018-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k172906-remedy-plus-hip-spacer-unite-plus-bone-fda-510k.jpg K172906 - REMEDY PLUS Hip Spacer, UNITE PLUS Bone Cement K172906 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteoremedies, LLC. Cleared Aug 2018. https://www.510kdatabase.net/k173205/ 2018-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k173205-equinox-advantage-fda-510k.jpg K173205 - Equinox Advantage K173205 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: O-Two Medical Technologies, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k180073/ 2018-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k180073-vitavitro-vitrification-kit-vitavitro-fda-510k.jpg K180073 - Vitavitro Vitrification Kit, Vitavitro Warming Kit, and Vitavitro Straw Set K180073 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shenzhen Vitavitro Bio-Tech Co., Ltd.. Cleared Aug 2018. https://www.510kdatabase.net/k180496/ 2018-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k180496-truclear-elite-hysteroscope-fda-510k.jpg K180496 - TruClear Elite Hysteroscope K180496 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Covidien. Cleared Aug 2018. https://www.510kdatabase.net/k180610/ 2018-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k180610-geister-retractor-for-neuro-and-spine-fda-510k.jpg K180610 - Geister retractor for neuro - and spine surgery K180610 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Geister Medizin Technik GmbH. Cleared Aug 2018. https://www.510kdatabase.net/k180802/ 2018-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k180802-meta-pbond-fda-510k.jpg K180802 - Meta P&Bond K180802 is a FDA 510(k) cleared dental medical device. Manufacturer: Meta Biomed Co., Ltd.. Cleared Aug 2018. https://www.510kdatabase.net/k181104/ 2018-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k181104-arm-type-blood-pressure-monitor-fda-510k.jpg K181104 - Arm type Blood Pressure Monitor, Digital Blood Pressure Monitor-Automatic Upper Arm Style K181104 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Combei Technology Co., Ltd.. Cleared Aug 2018. https://www.510kdatabase.net/k181185/ 2018-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k181185-change-healthcare-enterprise-viewer-fda-510k.jpg K181185 - Change Healthcare Enterprise Viewer K181185 is a FDA 510(k) cleared radiology medical device. Manufacturer: Change Healthcare Canada Company. Cleared Aug 2018. https://www.510kdatabase.net/k181295/ 2018-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k181295-genesys-spine-ais-c-cervical-stand-fda-510k.jpg K181295 - Genesys Spine AIS-C Cervical Stand-Alone System K181295 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Genesys Spine. Cleared Aug 2018. https://www.510kdatabase.net/k181471/ 2018-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k181471-accufuse-cervical-system-fda-510k.jpg K181471 - ACCUFUSE Cervical System K181471 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Absolute Advantage Medical, LLC. Cleared Aug 2018. https://www.510kdatabase.net/k181502/ 2018-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k181502-zio-at-ecg-monitoring-system-zeus-system-fda-510k.jpg K181502 - Zio AT ECG Monitoring System, ZEUS System K181502 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: iRhythm Technologies, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k181740/ 2018-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k181740-zeltiq-coolsculpting-system-fda-510k.jpg K181740 - ZELTIQ CoolSculpting System K181740 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Zeltiq Aesthetics, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k181799/ 2018-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k181799-rescube-ligament-fixation-system-fda-510k.jpg K181799 - ResCUBE™ Ligament Fixation System K181799 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Cousin Biotech Sas. Cleared Aug 2018. https://www.510kdatabase.net/k182054/ 2018-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k182054-natrelle-133s-tissue-expander-fda-510k.jpg K182054 - Natrelle 133S Tissue Expander K182054 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Allergan. Cleared Aug 2018. https://www.510kdatabase.net/k182119/ 2018-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k182119-cd-horizon-spinal-system-fda-510k.jpg K182119 - CD HORIZON™ Spinal System K182119 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k173952/ 2018-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k173952-universal-smartecg-fda-510k.jpg K173952 - Universal SmartECG K173952 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vectracor, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k181069/ 2018-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k181069-disposable-insulin-pen-needle-fda-510k.jpg K181069 - Disposable Insulin Pen Needle K181069 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zhejiang Kindly Medical Devices Co., Ltd.. Cleared Aug 2018. https://www.510kdatabase.net/k181367/ 2018-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k181367-tenex-health-tx-system-with-the-txp-fda-510k.jpg K181367 - Tenex Health TX System with the TXP MicroTip K181367 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Tenex Health, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k181683/ 2018-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k181683-bd-max-ctgctv-20-day-qc-panel-fda-510k.jpg K181683 - BD MAX CT/GC/TV 20-Day QC Panel K181683 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Microbiologics, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k181313/ 2018-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k181313-benq-diagnostic-ultrasound-system-fda-510k.jpg K181313 - BenQ Diagnostic Ultrasound System K181313 is a FDA 510(k) cleared radiology medical device. Manufacturer: Qisda Corporation. Cleared Aug 2018. https://www.510kdatabase.net/k181408/ 2018-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k181408-jo-classic-hybrid-personal-lubricant-fda-510k.jpg K181408 - JO Classic Hybrid Personal Lubricant K181408 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: United Consortium. Cleared Aug 2018. https://www.510kdatabase.net/k181473/ 2018-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k181473-denv-detect-ns1-elisa-fda-510k.jpg K181473 - DENV Detect NS1 ELISA K181473 is a FDA 510(k) cleared microbiology medical device. Manufacturer: InBios International, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k181483/ 2018-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k181483-tranquil-interbody-system-fda-510k.jpg K181483 - Tranquil Interbody System K181483 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nexus Spine, LLC. Cleared Aug 2018. https://www.510kdatabase.net/k181582/ 2018-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k181582-demetech-demediox-absorbable-surgical-fda-510k.jpg K181582 - DemeTECH DemeDIOX absorbable surgical suture K181582 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Demetech Corporation. Cleared Aug 2018. https://www.510kdatabase.net/k172830/ 2018-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k172830-double-medical-femoral-nail-system-fda-510k.jpg K172830 - Double Medical Femoral Nail System K172830 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Double Medical Technology, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k173541/ 2018-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k173541-epinaut-fda-510k.jpg K173541 - EPINAUT K173541 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Imedicom Co., Ltd.. Cleared Aug 2018. https://www.510kdatabase.net/k173673/ 2018-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k173673-acusnare-polypectomy-snare-fda-510k.jpg K173673 - AcuSnare Polypectomy Snare K173673 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Wilson-Cook Medical, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k173771/ 2018-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k173771-iolmaster-700-fda-510k.jpg K173771 - IOLMaster 700 K173771 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Carl Zeiss Meditec, AG. Cleared Aug 2018. https://www.510kdatabase.net/k173978/ 2018-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k173978-carto-3-ep-navigation-system-version-fda-510k.jpg K173978 - CARTO 3 EP Navigation System, Version 5.2 and Accessories with CARTOFINDER Module K173978 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biosense Webster, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k180040/ 2018-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k180040-nc-trek-rx-coronary-dilatation-catheter-fda-510k.jpg K180040 - NC TREK™ RX Coronary Dilatation Catheter K180040 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Vascular. Cleared Aug 2018. https://www.510kdatabase.net/k180179/ 2018-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k180179-firebird-spinal-fixation-systems-fda-510k.jpg K180179 - Firebird® Spinal Fixation Systems: Firebird System K180179 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthofix, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k180373/ 2018-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k180373-cancellex-porous-titanium-lumbar-fda-510k.jpg K180373 - CancelleX Porous Titanium Lumbar Interbody Device K180373 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Xenco Medical, LLC. Cleared Aug 2018. https://www.510kdatabase.net/k181009/ 2018-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k181009-aptus-cmc-i-fusion-plate-system-fda-510k.jpg K181009 - APTUS CMC-I Fusion Plate System K181009 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medartis AG. Cleared Aug 2018. https://www.510kdatabase.net/k181035/ 2018-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k181035-aos-small-fragment-plating-system-lite-fda-510k.jpg K181035 - AOS Small Fragment Plating System Lite K181035 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Advanced Orthopaedic Solutions, Inc. (Aos). Cleared Aug 2018. https://www.510kdatabase.net/k181060/ 2018-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k181060-solitaire-2-and-solitaire-platinum-fda-510k.jpg K181060 - Solitaire 2 and Solitaire Platinum Revascularization Device K181060 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Neurovascular. Cleared Aug 2018. https://www.510kdatabase.net/k181386/ 2018-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k181386-nuvasive-brigade-lateral-system-fda-510k.jpg K181386 - NuVasive Brigade Lateral System K181386 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Aug 2018. https://www.510kdatabase.net/k181609/ 2018-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k181609-radiforce-gx560-gx560-ar-fda-510k.jpg K181609 - RadiForce GX560, GX560-AR K181609 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eizo Corporation. Cleared Aug 2018. https://www.510kdatabase.net/k182057/ 2018-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k182057-easymax-bt-self-monitoring-blood-fda-510k.jpg K182057 - EasyMax BT Self-Monitoring Blood Glucose System K182057 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eps Bio Technology Corp.. Cleared Aug 2018. https://www.510kdatabase.net/k170050/ 2018-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k170050-z-cad-smile-fda-510k.jpg K170050 - Z-CAD smile K170050 is a FDA 510(k) cleared dental medical device. Manufacturer: Metoxit AG. Cleared Aug 2018. https://www.510kdatabase.net/k173657/ 2018-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k173657-radiancetm-clear-sharkletr-silicone-fda-510k.jpg K173657 - Radiance(TM) Clear Sharklet(R) Silicone Foley Catheter K173657 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Aug 2018. https://www.510kdatabase.net/k173732/ 2018-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k173732-optilite-freelite-mx-kappa-free-kit-fda-510k.jpg K173732 - Optilite Freelite Mx Kappa Free Kit, Optilite Freelite Mx Lambda Free Kit K173732 is a FDA 510(k) cleared immunology medical device. Manufacturer: The Binding Site Group , Ltd.. Cleared Aug 2018. https://www.510kdatabase.net/k173784/ 2018-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k173784-smylic-invisible-clear-aligners-fda-510k.jpg K173784 - Smylic Invisible Clear Aligners K173784 is a FDA 510(k) cleared dental medical device. Manufacturer: Smylio, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k173890/ 2018-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k173890-gmk-sphere-kinematic-alignment-fda-510k.jpg K173890 - GMK Sphere - Kinematic Alignment K173890 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Aug 2018. https://www.510kdatabase.net/k180173/ 2018-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k180173-freespira-fda-510k.jpg K180173 - Freespira K180173 is a FDA 510(k) cleared neurology medical device. Manufacturer: Palo Alto Health Sciences, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k180186/ 2018-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k180186-stat-profile-prime-plus-analyzer-system-fda-510k.jpg K180186 - Stat Profile Prime Plus Analyzer System K180186 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Nova Biomedical Corporation. Cleared Aug 2018. https://www.510kdatabase.net/k181333/ 2018-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k181333-advia-centaur-herpes-1-igg-fda-510k.jpg K181333 - ADVIA Centaur Herpes-1 IgG K181333 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Biokit, S.A.. Cleared Aug 2018. https://www.510kdatabase.net/k181334/ 2018-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k181334-advia-centaur-herpes-2-igg-fda-510k.jpg K181334 - ADVIA Centaur Herpes-2 IgG K181334 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Biokit, S.A.. Cleared Aug 2018. https://www.510kdatabase.net/k181439/ 2018-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k181439-spyglass-ds-and-ds-ii-direct-fda-510k.jpg K181439 - SpyGlass DS and DS II Direct Visualization System K181439 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Aug 2018. https://www.510kdatabase.net/k181635/ 2018-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k181635-gmk-sphere-cr-tibial-inserts-fda-510k.jpg K181635 - GMK Sphere CR Tibial Inserts K181635 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Aug 2018. https://www.510kdatabase.net/k181974/ 2018-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k181974-myosure-xl-tissue-removal-device-for-fda-510k.jpg K181974 - MyoSure XL Tissue Removal Device for Fluent K181974 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Hologic, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/den170090/ 2018-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/den170090-matrx-plus-fda-510k.jpg DEN170090 - MATRx plus DEN170090 is a FDA 510(k) cleared dental medical device. Manufacturer: Zephyr Sleep Technologies. Cleared Aug 2018. https://www.510kdatabase.net/k173024/ 2018-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k173024-non-invasive-blood-pressure-fda-510k.jpg K173024 - Non-invasive blood pressure measurement systems K173024 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Joytech Healthcare Co. , Ltd.. Cleared Aug 2018. https://www.510kdatabase.net/k180542/ 2018-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k180542-nim-pak-needle-fda-510k.jpg K180542 - NIM PAK Needle K180542 is a FDA 510(k) cleared neurology medical device. Manufacturer: Boston Endo Surgical Tech,. Cleared Aug 2018. https://www.510kdatabase.net/k181312/ 2018-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k181312-grandioso-x-tra-fda-510k.jpg K181312 - GrandioSO x-tra K181312 is a FDA 510(k) cleared dental medical device. Manufacturer: Voco GmbH. Cleared Aug 2018. https://www.510kdatabase.net/k181954/ 2018-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k181954-autolog-iq-autotransfusion-system-fda-510k.jpg K181954 - autoLog IQ Autotransfusion System K181954 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Perfusion Systems. Cleared Aug 2018. https://www.510kdatabase.net/k173197/ 2018-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k173197-reusable-nibp-cuff-fda-510k.jpg K173197 - Reusable NIBP Cuff K173197 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Orantech, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k173658/ 2018-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k173658-confidence-blood-glucose-monitoring-fda-510k.jpg K173658 - Confidence Blood Glucose Monitoring System K173658 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Applied Biomedical, LLC. Cleared Aug 2018. https://www.510kdatabase.net/k180698/ 2018-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k180698-pico-7-single-use-negative-pressure-fda-510k.jpg K180698 - PICO 7 Single Use Negative Pressure Wound Therapy System K180698 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew Medical Limited. Cleared Aug 2018. https://www.510kdatabase.net/k180957/ 2018-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k180957-exgraft-exgraft-carbon-eptfe-vascular-fda-510k.jpg K180957 - exGraft, exGraft Carbon ePTFE Vascular Grafts K180957 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Peca Labs. Cleared Aug 2018. https://www.510kdatabase.net/k181013/ 2018-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k181013-fever-scout-fda-510k.jpg K181013 - Fever Scout K181013 is a FDA 510(k) cleared general hospital medical device. Manufacturer: VivaLNK, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k181379/ 2018-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k181379-h-pylori-quik-chek-fda-510k.jpg K181379 - H. PYLORI QUIK CHEK K181379 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Techlab, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k181400/ 2018-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k181400-h-pylori-chek-fda-510k.jpg K181400 - H. PYLORI CHEK™ K181400 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Techlab, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k181435/ 2018-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k181435-atec-cervical-spacer-system-fda-510k.jpg K181435 - ATEC Cervical Spacer System K181435 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k181791/ 2018-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k181791-simplystrong-simplyezee-fda-510k.jpg K181791 - SIMPLYSTRONG, SIMPLYEZEE K181791 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Genicon, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k181973/ 2018-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k181973-medtronic-model-5392-external-pulse-fda-510k.jpg K181973 - Medtronic Model 5392 External Pulse Generator (EPG) K181973 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k181982/ 2018-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k181982-midascope-and-introducer-kit-and-fda-510k.jpg K181982 - MIDAScope and Introducer Kit, and MIDASystem K181982 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intravu, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k182004/ 2018-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k182004-pentax-medical-endoscopic-ultrasound-fda-510k.jpg K182004 - PENTAX Medical Endoscopic Ultrasound System K182004 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Pentax of America, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k170824/ 2018-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k170824-bd-vacutainer-eclipse-signal-blood-fda-510k.jpg K170824 - BD Vacutainer Eclipse Signal Blood Collection Needle K170824 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson and Company. Cleared Aug 2018. https://www.510kdatabase.net/k171377/ 2018-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k171377-young-infinity-cordless-handpiece-system-fda-510k.jpg K171377 - Young INFINITY Cordless Handpiece System K171377 is a FDA 510(k) cleared dental medical device. Manufacturer: Young Dental Manufacturing Co. 1, LLC. Cleared Aug 2018. https://www.510kdatabase.net/k171890/ 2018-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k171890-bexcore-breast-biopsy-system-biopsy-fda-510k.jpg K171890 - BEXCORE Breast Biopsy System, Biopsy Needle K171890 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medical Park Co., Ltd.. Cleared Aug 2018. https://www.510kdatabase.net/k180850/ 2018-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k180850-reta-reuseable-tampon-applicator-fda-510k.jpg K180850 - re.t.a Reuseable Tampon Applicator K180850 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Thinx, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k181768/ 2018-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k181768-assuretech-panel-dip-tests-assuretech-fda-510k.jpg K181768 - AssureTech Panel Dip Tests, AssureTech Quick Cup Tests K181768 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Assure Tech. (Hangzhou) Co, Ltd.. Cleared Aug 2018. https://www.510kdatabase.net/k181968/ 2018-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k181968-safecare-multi-drug-urine-test-cup-fda-510k.jpg K181968 - SAFECARE Multi-Drug Urine Test Cup, SAFECARE Multi-Drug Urine Test Dip-Card K181968 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Safecare Biotech (Hangzhou) Co., Ltd.. Cleared Aug 2018. https://www.510kdatabase.net/k172492/ 2018-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k172492-optical-topography-system-etg-4100-fda-510k.jpg K172492 - Optical Topography System ETG-4100 K172492 is a FDA 510(k) cleared neurology medical device. Manufacturer: Hitachi Healthcare Americas. Cleared Aug 2018. https://www.510kdatabase.net/k173257/ 2018-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k173257-bti-dental-implant-system-unicca-fda-510k.jpg K173257 - BTI Dental Implant System UnicCa K173257 is a FDA 510(k) cleared dental medical device. Manufacturer: B.T.I. Biotechnology Institute, Sl.. Cleared Aug 2018. https://www.510kdatabase.net/k173509/ 2018-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k173509-biodegradable-nitrile-powder-free-fda-510k.jpg K173509 - Biodegradable Nitrile Powder Free Examination Glove (Blue) K173509 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hartalega Sdn Bhd. Cleared Aug 2018. https://www.510kdatabase.net/k173516/ 2018-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k173516-nuborne-infant-warmer-fda-510k.jpg K173516 - NuBorne Infant Warmer K173516 is a FDA 510(k) cleared general hospital medical device. Manufacturer: International Biomedical. Cleared Aug 2018. https://www.510kdatabase.net/k173575/ 2018-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k173575-osteoready-dental-implant-system-fda-510k.jpg K173575 - OsteoReady Dental Implant System K173575 is a FDA 510(k) cleared dental medical device. Manufacturer: Osteoready, LLC. Cleared Aug 2018. https://www.510kdatabase.net/k173608/ 2018-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k173608-forest-dental-unit-fda-510k.jpg K173608 - Forest Dental Unit K173608 is a FDA 510(k) cleared dental medical device. Manufacturer: Forest Dental Products, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k173638/ 2018-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k173638-rightest-blood-glucose-monitoring-fda-510k.jpg K173638 - Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max Plus K173638 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bionime Corporation. Cleared Aug 2018. https://www.510kdatabase.net/k173663/ 2018-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k173663-electronic-stethoscope-ds3011a-fda-510k.jpg K173663 - Electronic Stethoscope DS3011A K173663 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Imediplus, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k173761/ 2018-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k173761-penumbra-system-reperfusion-catheter-fda-510k.jpg K173761 - Penumbra System Reperfusion Catheter JET 7 K173761 is a FDA 510(k) cleared neurology medical device. Manufacturer: Penumbra, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k173773/ 2018-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k173773-medrad-stellant-flex-ct-injection-fda-510k.jpg K173773 - MEDRAD Stellant FLEX CT Injection System with Certegra Workstation, MEDRAD Stellant FLEX Syringe Kits, MEDRAD Stellant CT Injection System with Certegra Workstation, MEDRAD Stellant Syringe Kits, MEDRAD Stellant Connector Tubing, P3T Cardiac, P3T PA, P3T Abdomen, ISI, Connect.CT K173773 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bayer Medical Care, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k173918/ 2018-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k173918-versapap-positive-airway-pressure-pap-fda-510k.jpg K173918 - VersaPAP Positive Airway Pressure (PAP) Device K173918 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Trudell Medical International. Cleared Aug 2018. https://www.510kdatabase.net/k180574/ 2018-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k180574-halo-closed-vial-adaptor-multiple-fda-510k.jpg K180574 - Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo Closed Syringe Adaptor, Halo Closed Line Adaptor, Closed Vial Adaptor K180574 is a FDA 510(k) cleared general hospital medical device. Manufacturer: J & J Solutions, Inc. D/B/A/ Corvida Medical. Cleared Aug 2018. https://www.510kdatabase.net/k180775/ 2018-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k180775-watch-pat300-fda-510k.jpg K180775 - Watch-PAT300 K180775 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Itamar Medical , Ltd.. Cleared Aug 2018. https://www.510kdatabase.net/k180943/ 2018-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k180943-biowavego-fda-510k.jpg K180943 - BioWaveGO K180943 is a FDA 510(k) cleared neurology medical device. Manufacturer: Biowave Corporation. Cleared Aug 2018. https://www.510kdatabase.net/k180974/ 2018-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k180974-cbit-series-digital-color-doppler-fda-510k.jpg K180974 - CBit Series Digital Color Doppler Ultrasound System K180974 is a FDA 510(k) cleared radiology medical device. Manufacturer: CHISON Medical Technologies Co., Ltd.. Cleared Aug 2018. https://www.510kdatabase.net/k181074/ 2018-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k181074-simple-science-antimicrobial-facial-fda-510k.jpg K181074 - Simple Science Antimicrobial Facial and Eyelid Cleanser K181074 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Simple Science, LLC. Cleared Aug 2018. https://www.510kdatabase.net/k181306/ 2018-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k181306-actifuse-flow-fda-510k.jpg K181306 - Actifuse Flow K181306 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Baxter Healthcare Corporation. Cleared Aug 2018. https://www.510kdatabase.net/k181713/ 2018-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k181713-ultraxx-nephrostomy-balloon-catheter-set-fda-510k.jpg K181713 - Ultraxx Nephrostomy Balloon Catheter Set K181713 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Aug 2018. https://www.510kdatabase.net/k181767/ 2018-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k181767-cios-select-fda-510k.jpg K181767 - Cios Select K181767 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k181923/ 2018-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k181923-quantum-workstation-121-fda-510k.jpg K181923 - Quantum Workstation 12.1 K181923 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Spectrum Medical , Ltd.. Cleared Aug 2018. https://www.510kdatabase.net/k181940/ 2018-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k181940-gore-seamguard-bioabsorbable-staple-fda-510k.jpg K181940 - GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement K181940 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k181943/ 2018-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k181943-oscar-oscar-prime-oscar-classic-fda-510k.jpg K181943 - OSCAR (OSCAR Prime, OSCAR Classic) K181943 is a FDA 510(k) cleared radiology medical device. Manufacturer: Genoray Co., Ltd.. Cleared Aug 2018. https://www.510kdatabase.net/k181966/ 2018-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k181966-smartperfusion-fda-510k.jpg K181966 - SmartPerfusion K181966 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederlands B.V.. Cleared Aug 2018. https://www.510kdatabase.net/k181983/ 2018-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k181983-prexion-3d-excelsior-fda-510k.jpg K181983 - PreXion 3D Excelsior K181983 is a FDA 510(k) cleared radiology medical device. Manufacturer: Prexion Corporation. Cleared Aug 2018. https://www.510kdatabase.net/den170078/ 2018-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/den170078-brainsway-deep-transcranial-magnetic-fda-510k.jpg DEN170078 - Brainsway Deep Transcranial Magnetic Stimulation (DTMS) System DEN170078 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainways , Ltd.. Cleared Aug 2018. https://www.510kdatabase.net/k173454/ 2018-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k173454-multi-parameter-patient-monitor-models-fda-510k.jpg K173454 - Multi-parameter Patient Monitor, models C30 K173454 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Comen Medical Instruments Co.,Ltd. Cleared Aug 2018. https://www.510kdatabase.net/k180077/ 2018-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k180077-neuroq-38-fda-510k.jpg K180077 - NeuroQ 3.8 K180077 is a FDA 510(k) cleared radiology medical device. Manufacturer: Syntermed. Cleared Aug 2018. https://www.510kdatabase.net/k180522/ 2018-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k180522-igtfusion-fda-510k.jpg K180522 - IGTFusion K180522 is a FDA 510(k) cleared radiology medical device. Manufacturer: Igi Technologies. Cleared Aug 2018. https://www.510kdatabase.net/k180619/ 2018-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k180619-bongo-fda-510k.jpg K180619 - Bongo K180619 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Innomed Healthscience, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k181020/ 2018-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k181020-cytosponge-cell-collection-device-fda-510k.jpg K181020 - Cytosponge Cell Collection Device K181020 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Covidien, LLC. Cleared Aug 2018. https://www.510kdatabase.net/k181206/ 2018-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k181206-gentlecath-glide-intermittent-urinary-fda-510k.jpg K181206 - GentleCath Glide Intermittent Urinary Catheter K181206 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Convatec Limited. Cleared Aug 2018. https://www.510kdatabase.net/k181909/ 2018-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k181909-luminelle-dtx-hysteroscopy-system-fda-510k.jpg K181909 - Luminelle DTx Hysteroscopy System K181909 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Uvision360, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k173703/ 2018-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k173703-sonata-sonography-guided-transcervical-fda-510k.jpg K173703 - Sonata Sonography-Guided Transcervical Fibroid Ablation System K173703 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Gynesonics, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k180428/ 2018-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k180428-stat-profile-prime-plus-analyzer-system-fda-510k.jpg K180428 - Stat Profile Prime Plus Analyzer System K180428 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Nova Biomedical Corporation. Cleared Aug 2018. https://www.510kdatabase.net/k181289/ 2018-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k181289-xpert-xpress-flu-xpert-nasopharyngeal-fda-510k.jpg K181289 - Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48S System and GeneXpert Infinity-80 System K181289 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Cepheid. Cleared Aug 2018. https://www.510kdatabase.net/k181308/ 2018-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k181308-supergrow-272-ultimate-272-fda-510k.jpg K181308 - SuperGrow 272, Ultimate 272 K181308 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Super Grow Lasers. Cleared Aug 2018. https://www.510kdatabase.net/k181347/ 2018-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k181347-aries-lumbar-interbodies-fda-510k.jpg K181347 - Aries® Lumbar Interbodies K181347 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osseus Fusion Systems, LLC. Cleared Aug 2018. https://www.510kdatabase.net/k181359/ 2018-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k181359-interactive-smartbase-abutments-fda-510k.jpg K181359 - InterActive SMARTBase Abutments K181359 is a FDA 510(k) cleared dental medical device. Manufacturer: Implant Direct Sybron Manufacturing, LLC. Cleared Aug 2018. https://www.510kdatabase.net/k181407/ 2018-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k181407-artis-zeezeego-artis-qqzen-fda-510k.jpg K181407 - Artis zee/zeego & Artis Q/Q.zen K181407 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solution USA, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k181500/ 2018-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k181500-brilliant-crios-fda-510k.jpg K181500 - BRILLIANT Crios K181500 is a FDA 510(k) cleared dental medical device. Manufacturer: Coltene/Whaledent AG. Cleared Aug 2018. https://www.510kdatabase.net/k181592/ 2018-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k181592-rain-sheath-transradial-fda-510k.jpg K181592 - RAIN Sheath Transradial K181592 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corporation. Cleared Aug 2018. https://www.510kdatabase.net/k181676/ 2018-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k181676-mini-ridge-filter-and-auxiliary-fda-510k.jpg K181676 - Mini Ridge Filter and auxiliary functions for PROBEAT-V K181676 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hitachi Ltd. Healthcare Hitachi Works. Cleared Aug 2018. https://www.510kdatabase.net/k181711/ 2018-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k181711-bd-max-enteric-parasite-control-panel-fda-510k.jpg K181711 - BD MAX Enteric Parasite Control Panel, BD MAX Enteric Parasite 20-Day QC Panel K181711 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Microbiologics, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k173620/ 2018-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k173620-mag-vita-tms-therapy-system-wtheta-fda-510k.jpg K173620 - Mag Vita TMS Therapy System w/Theta Burst Stimulation K173620 is a FDA 510(k) cleared neurology medical device. Manufacturer: Tonica Elektronik A/S. Cleared Aug 2018. https://www.510kdatabase.net/k180131/ 2018-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k180131-vicks-rapidread-digital-thermometer-fda-510k.jpg K180131 - Vicks RapidRead Digital Thermometer K180131 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Kaz USA, Inc., A Helen of Troy Company. Cleared Aug 2018. https://www.510kdatabase.net/k181414/ 2018-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k181414-uct-530-uct-550-fda-510k.jpg K181414 - uCT 530, uCT 550 K181414 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Aug 2018. https://www.510kdatabase.net/k181792/ 2018-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k181792-duo-lumbar-interbody-fusion-device-fda-510k.jpg K181792 - Duo™ Lumbar Interbody Fusion Device K181792 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spineology, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k181977/ 2018-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k181977-wiscope-digital-endoscope-system-fda-510k.jpg K181977 - WiScope Digital Endoscope System K181977 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: OTU Medical, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k182067/ 2018-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k182067-pleuraflow-system-with-flowglide-extra-fda-510k.jpg K182067 - PleuraFlow System with FlowGlide Extra Drainage Length K182067 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Clearflow, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k173123/ 2018-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k173123-pulse-oximeter-fda-510k.jpg K173123 - Pulse Oximeter K173123 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Imdk Medical Technology Co., Ltd.. Cleared Aug 2018. https://www.510kdatabase.net/k173498/ 2018-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k173498-simplexa-bordetella-direct-simplexa-fda-510k.jpg K173498 - Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack K173498 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Diasorin Molecular, LLC. Cleared Aug 2018. https://www.510kdatabase.net/k173549/ 2018-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k173549-biafine-fda-510k.jpg K173549 - BIAFINE K173549 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Valeant Pharmaceuticals. Cleared Aug 2018. https://www.510kdatabase.net/k180539/ 2018-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k180539-deformity-analysis-and-correction-fda-510k.jpg K180539 - Deformity Analysis and Correction Software (DACS) and Instrumentation K180539 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arrowhead Medical Device Technologies, LLC. Cleared Aug 2018. https://www.510kdatabase.net/k180962/ 2018-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k180962-kls-martin-individual-patient-solutions-fda-510k.jpg K180962 - KLS Martin Individual Patient Solutions K180962 is a FDA 510(k) cleared dental medical device. Manufacturer: KLS-Martin L.P.. Cleared Aug 2018. https://www.510kdatabase.net/k180990/ 2018-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k180990-tirbolox-l-lumbar-ibfd-fda-510k.jpg K180990 - TirboLOX-L Lumbar IBFD K180990 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Captiva Spine, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k181318/ 2018-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k181318-onis-pacs-fda-510k.jpg K181318 - ONIS-PACS K181318 is a FDA 510(k) cleared radiology medical device. Manufacturer: Digitalcore Co., Ltd.. Cleared Aug 2018. https://www.510kdatabase.net/k181593/ 2018-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k181593-vantage-galan-3t-mrt-3020a7-v50-fda-510k.jpg K181593 - Vantage Galan 3T, MRT-3020/A7, V5.0 K181593 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Aug 2018. https://www.510kdatabase.net/k181978/ 2018-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k181978-zenius-iliad-and-kora-spinal-fixation-fda-510k.jpg K181978 - Zenius™, Iliad™ and Kora™ Spinal Fixation Systems K181978 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medyssey USA, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k173248/ 2018-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k173248-cardioskin-fda-510k.jpg K173248 - CARDIOSKIN K173248 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bioserenity Sas. Cleared Aug 2018. https://www.510kdatabase.net/k170110/ 2018-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k170110-diana-medication-transfer-set-fda-510k.jpg K170110 - Diana Medication Transfer Set K170110 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Icu Medical, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k180234/ 2018-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k180234-physiq-heart-rhythm-module-fda-510k.jpg K180234 - physiQ Heart Rhythm Module K180234 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Physiq, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k180644/ 2018-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k180644-nitrile-powder-free-examination-gloves-fda-510k.jpg K180644 - Nitrile Powder Free Examination Gloves with Colloidal Oatmeal - Lemon Green K180644 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hartalega Sdn Bhd. Cleared Aug 2018. https://www.510kdatabase.net/k180814/ 2018-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k180814-corelink-m3-stand-alone-anterior-fda-510k.jpg K180814 - CoreLink® M3™ Stand-Alone Anterior Lumbar System K180814 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corelink, LLC. Cleared Aug 2018. https://www.510kdatabase.net/k180834/ 2018-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k180834-altrix-precision-temperature-fda-510k.jpg K180834 - Altrix Precision Temperature Management System K180834 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Stryker Medical. Cleared Aug 2018. https://www.510kdatabase.net/k181130/ 2018-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k181130-powder-free-blue-nitrile-examination-fda-510k.jpg K181130 - Powder Free Blue Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs K181130 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hebei Titans Hongsen Medical Technology Co., Ltd.. Cleared Aug 2018. https://www.510kdatabase.net/k181151/ 2018-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k181151-gynecare-tvt-abbrevo-continence-system-fda-510k.jpg K181151 - GYNECARE TVT Abbrevo Continence System K181151 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k181253/ 2018-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k181253-bosley-revitalizer-272-laser-cap-fda-510k.jpg K181253 - Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup K181253 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC. Cleared Aug 2018. https://www.510kdatabase.net/k181584/ 2018-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k181584-redi-spine-fda-510k.jpg K181584 - Redi-Spine K181584 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Innovative Surgical Designs, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k181627/ 2018-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k181627-bausch-lomb-boston-simplusmulti-action-fda-510k.jpg K181627 - Bausch + Lomb Boston SimplusMulti-Action Solution, Bausch + Lomb Boston One Step Liquid Enzymatic Cleaner K181627 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Bausch & Lomb, Incorporated. Cleared Aug 2018. https://www.510kdatabase.net/k181849/ 2018-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k181849-istim-s2-otc-pain-relief-tens-fda-510k.jpg K181849 - iStim S2 OTC Pain Relief TENS K181849 is a FDA 510(k) cleared neurology medical device. Manufacturer: Everyway Medical Instruments Co., Ldt.. Cleared Aug 2018. https://www.510kdatabase.net/k181891/ 2018-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k181891-portable-x-ray-system-model-minix-v-fda-510k.jpg K181891 - Portable X-ray System (Model: MiniX-V, Mini X-S) K181891 is a FDA 510(k) cleared radiology medical device. Manufacturer: Digimed Co., Ltd.. Cleared Aug 2018. https://www.510kdatabase.net/den170052/ 2018-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/den170052-natural-cycles-fda-510k.jpg DEN170052 - Natural Cycles DEN170052 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Natural Cycles Nordic AB. Cleared Aug 2018. https://www.510kdatabase.net/k171245/ 2018-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k171245-presygensi-1-fda-510k.jpg K171245 - Presygen/si-1 K171245 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Christie Medical Holdings, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k173407/ 2018-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k173407-vt-100-vt-200-fda-510k.jpg K173407 - VT - 100, VT - 200 K173407 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Carilex Medical, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k173505/ 2018-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k173505-fora-gtel-blood-glucose-monitoring-fda-510k.jpg K173505 - FORA GTel Blood Glucose Monitoring System K173505 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Foracare, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k173819/ 2018-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k173819-myplant-ii-implant-system-fda-510k.jpg K173819 - MyPlant II Implant System K173819 is a FDA 510(k) cleared dental medical device. Manufacturer: Hager& Meisinger GmbH. Cleared Aug 2018. https://www.510kdatabase.net/k173844/ 2018-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k173844-titan-ag-200-fda-510k.jpg K173844 - Titan Ag 200 K173844 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Specialty Fibres and Materials, Ltd.. Cleared Aug 2018. https://www.510kdatabase.net/k180417/ 2018-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k180417-self-destruction-safety-syringes-for-fda-510k.jpg K180417 - Self-destruction Safety Syringes for Single Use K180417 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Berpu Medical Technology Co., Ltd.. Cleared Aug 2018. https://www.510kdatabase.net/k180759/ 2018-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k180759-seculok-suture-anchor-fda-510k.jpg K180759 - SECULOK™ Suture Anchor K180759 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: U&I Corporation. Cleared Aug 2018. https://www.510kdatabase.net/k181430/ 2018-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k181430-lensar-laser-system-fs-3d-lls-fs-3d-fda-510k.jpg K181430 - LENSAR Laser System - fs 3D (LLS-fs 3D) K181430 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Lensar, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k181533/ 2018-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k181533-evos-wrist-fracture-plating-system-fda-510k.jpg K181533 - EVOS Wrist Fracture Plating System K181533 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k181544/ 2018-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k181544-anchor-bolt-as-an-accessory-to-depth-fda-510k.jpg K181544 - Anchor Bolt (as an accessory to Depth Electrodes) K181544 is a FDA 510(k) cleared neurology medical device. Manufacturer: Ad-Tech Medical Instrument Corporation. Cleared Aug 2018. https://www.510kdatabase.net/k181557/ 2018-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k181557-infinity-total-ankle-system-fda-510k.jpg K181557 - INFINITY Total Ankle System K181557 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Aug 2018. https://www.510kdatabase.net/k181677/ 2018-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k181677-kodiak-spinal-fixation-system-fda-510k.jpg K181677 - Kodiak Spinal Fixation System K181677 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k181680/ 2018-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k181680-iconn-answer-ii-suture-anchor-fda-510k.jpg K181680 - ICONN Answer II Suture Anchor K181680 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Iconn Orthopedics, LLC. Cleared Aug 2018. https://www.510kdatabase.net/k181866/ 2018-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k181866-motocliphimax-step-staple-implant-system-fda-510k.jpg K181866 - MotoCLIP/HiMAX Step Staple Implant System K181866 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Crossroads Extremity Systems, LLC. Cleared Aug 2018. https://www.510kdatabase.net/k172508/ 2018-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k172508-ageless-health-medical-digital-fda-510k.jpg K172508 - Ageless Health Medical Digital Thermometer K172508 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ageless Health Industrial Co., Ltd.. Cleared Aug 2018. https://www.510kdatabase.net/k173193/ 2018-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k173193-fp-sleepstyle-fda-510k.jpg K173193 - F&P SleepStyle K173193 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Fisher &Paykel Healthcare , Ltd.. Cleared Aug 2018. https://www.510kdatabase.net/k180169/ 2018-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k180169-eagleray-long-sheath-0088-id-80cm-90cm-fda-510k.jpg K180169 - EagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access Catheter, 0.071 ID, 137cm Length, EagleRay Access Catheter, 0.055 ID, 137cm Length, EagleRay Access Catheter, 0.045 ID, 144cm Length, EagleRay Access Catheter, 0.035 ID, 158cm Length K180169 is a FDA 510(k) cleared neurology medical device. Manufacturer: Imperative Care, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k180221/ 2018-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k180221-powder-free-white-green-sterilized-fda-510k.jpg K180221 - Powder Free White, Green Sterilized Polychloroprene Copolymer Surgical Gloves - Tested for Use with Chemotherapy Drugs K180221 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Smart Glove Corporation Sdn. Bhd.. Cleared Aug 2018. https://www.510kdatabase.net/k180598/ 2018-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k180598-uniqa-dental-implants-system-fda-510k.jpg K180598 - UNIQA Dental Implants System K180598 is a FDA 510(k) cleared dental medical device. Manufacturer: Uniqa Dental, Ltd.. Cleared Aug 2018. https://www.510kdatabase.net/k180734/ 2018-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k180734-smartlinx-vitals-plus-patient-fda-510k.jpg K180734 - SmartLinx Vitals Plus Patient Monitoring System K180734 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Capsule Technologie. Cleared Aug 2018. https://www.510kdatabase.net/k180805/ 2018-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k180805-pure-ep-fda-510k.jpg K180805 - Pure EP K180805 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biosig Technologies. Cleared Aug 2018. https://www.510kdatabase.net/k181041/ 2018-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k181041-7d-surgical-system-cranial-application-fda-510k.jpg K181041 - 7D Surgical System Cranial Application K181041 is a FDA 510(k) cleared neurology medical device. Manufacturer: 7D Surgical, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k181836/ 2018-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k181836-4f-infiniti-angiographic-catheter-4f-fda-510k.jpg K181836 - 4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters K181836 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis, A Cardinal Health Company. Cleared Aug 2018. https://www.510kdatabase.net/k181853/ 2018-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k181853-alere-binaxnow-influenza-a-b-card-2-fda-510k.jpg K181853 - Alere BinaxNOW Influenza A & B Card 2, Alere Reader K181853 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Alere Scarborough, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k181946/ 2018-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k181946-sensititre-18-24-hour-mic-breakpoint-fda-510k.jpg K181946 - Sensititre 18-24 hour MIC Breakpoint Susceptibility System with Plazomicin in the dilution range of 0.06-128 ug/mL K181946 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Thermo Fisher Scientific. Cleared Aug 2018. https://www.510kdatabase.net/k173848/ 2018-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k173848-model-wp-3840-and-wp-3040-fda-510k.jpg K173848 - Model WP-3840 and WP-3040 K173848 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cnmc Co., Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k180248/ 2018-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k180248-vascuease-ic-1200-wh-fda-510k.jpg K180248 - VascuEase IC-1200-WH K180248 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bio Compression Systems, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k180351/ 2018-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k180351-endowrist-mercury-bipolar-grasper-fda-510k.jpg K180351 - EndoWrist Mercury Bipolar Grasper K180351 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k180634/ 2018-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k180634-surgical-silver-post-operative-dressing-fda-510k.jpg K180634 - Surgical Silver Post Operative Dressing K180634 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Advanced Medical Solutions, Ltd.. Cleared Aug 2018. https://www.510kdatabase.net/k181218/ 2018-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k181218-alignrt-plus-fda-510k.jpg K181218 - AlignRT Plus K181218 is a FDA 510(k) cleared radiology medical device. Manufacturer: Vision Rt, Ltd.. Cleared Aug 2018. https://www.510kdatabase.net/k181234/ 2018-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k181234-self-adhesive-electrode-fda-510k.jpg K181234 - Self-adhesive Electrode K181234 is a FDA 510(k) cleared neurology medical device. Manufacturer: Dong Guan OU Kang Electronics Co., Ltd.. Cleared Aug 2018. https://www.510kdatabase.net/k181828/ 2018-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k181828-volo-14-guidewire-200cm-soft-profile-fda-510k.jpg K181828 - Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile K181828 is a FDA 510(k) cleared neurology medical device. Manufacturer: Scientia Vascular, LLC. Cleared Aug 2018. https://www.510kdatabase.net/k181962/ 2018-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k181962-cubevue-fda-510k.jpg K181962 - CubeVue K181962 is a FDA 510(k) cleared radiology medical device. Manufacturer: Curvebeam, LLC. Cleared Aug 2018. https://www.510kdatabase.net/k173845/ 2018-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k173845-arthrex-swivelock-fda-510k.jpg K173845 - Arthrex SwiveLock K173845 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k180075/ 2018-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k180075-minuet-lcd-minuet-lcd-eco-fda-510k.jpg K180075 - MINUET LCD, MINUET LCD eco K180075 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Unimom.Co. Cleared Aug 2018. https://www.510kdatabase.net/k180853/ 2018-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k180853-ep-granules-bvf-fda-510k.jpg K180853 - EP Granules™ BVF K180853 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Elute, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k181346/ 2018-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k181346-cystosure-plus-catheter-fda-510k.jpg K181346 - CystoSure Plus Catheter K181346 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Emmy Medical, LLC. Cleared Aug 2018. https://www.510kdatabase.net/k181217/ 2018-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k181217-vesoflow-lite-dvt-compression-device-fda-510k.jpg K181217 - VesoFlow Lite DVT Compression Device K181217 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Caremed Supply, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k181425/ 2018-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k181425-aptus-proximal-humerus-system-fda-510k.jpg K181425 - APTUS® Proximal Humerus System K181425 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medartis AG. Cleared Aug 2018. https://www.510kdatabase.net/k163578/ 2018-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k163578-easytouch-safety-pen-needle-fda-510k.jpg K163578 - EasyTouch Safety Pen Needle K163578 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Mhc Medical Products, LLC. Cleared Aug 2018. https://www.510kdatabase.net/k171435/ 2018-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k171435-virtuost-vertebral-fracture-assessment-fda-510k.jpg K171435 - VirtuOst Vertebral Fracture Assessment K171435 is a FDA 510(k) cleared radiology medical device. Manufacturer: O.N. Diagnostics, LLC. Cleared Aug 2018. https://www.510kdatabase.net/k172280/ 2018-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k172280-bh-sterilization-pouch-fda-510k.jpg K172280 - BH Sterilization Pouch K172280 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bh Medical Products Co., Ltd.. Cleared Aug 2018. https://www.510kdatabase.net/k173461/ 2018-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k173461-ecg-recorder-and-arrhythmia-detector-fda-510k.jpg K173461 - ECG recorder and Arrhythmia Detector K173461 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Smart Solutions Technologies SL. Cleared Aug 2018. https://www.510kdatabase.net/k180155/ 2018-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k180155-arm-type-blood-pressure-monitor-fda-510k.jpg K180155 - Arm Type Blood Pressure Monitor K180155 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Avita Corporation. Cleared Aug 2018. https://www.510kdatabase.net/k180341/ 2018-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k180341-fujifilm-600-series-endoscope-eg-600wr-fda-510k.jpg K180341 - FUJIFILM 600 Series Endoscope EG-600WR v2 K180341 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fujifilm Corporation. Cleared Aug 2018. https://www.510kdatabase.net/k180777/ 2018-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k180777-k2m-expandable-interbody-system-fda-510k.jpg K180777 - K2M Expandable Interbody System K180777 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: K2m, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k180825/ 2018-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k180825-fluent-fluid-management-system-fda-510k.jpg K180825 - Fluent Fluid Management System K180825 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Hologic, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k180907/ 2018-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k180907-horizon-tms-therapy-system-fda-510k.jpg K180907 - HORIZON TMS Therapy System K180907 is a FDA 510(k) cleared neurology medical device. Manufacturer: Magstim Company, Ltd.. Cleared Aug 2018. https://www.510kdatabase.net/k181146/ 2018-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k181146-ask-system-fda-510k.jpg K181146 - ASK System K181146 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: L and K Biomed Corporation Limited. Cleared Aug 2018. https://www.510kdatabase.net/k181149/ 2018-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k181149-therm-x-pro-therm-x-at-therm-x-pro-fda-510k.jpg K181149 - Therm-X Pro, Therm-X AT, Therm-X Pro Athlete K181149 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zenith Technical Innovations. Cleared Aug 2018. https://www.510kdatabase.net/k181197/ 2018-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k181197-phmb-foam-wound-dressing-fda-510k.jpg K181197 - PHMB Foam Wound Dressing K181197 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Advanced Medical Solutions, Ltd.. Cleared Aug 2018. https://www.510kdatabase.net/k181219/ 2018-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k181219-optipillows-epap-mask-fda-510k.jpg K181219 - OptiPillows EPAP Mask K181219 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Cpapnea Medical Supply. Cleared Aug 2018. https://www.510kdatabase.net/k181237/ 2018-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k181237-glidesheath-slender-tibial-pedal-kit-fda-510k.jpg K181237 - Glidesheath Slender Tibial Pedal Kit K181237 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corporation. Cleared Aug 2018. https://www.510kdatabase.net/k181323/ 2018-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k181323-atlas-gold-pta-dilatation-catheter-fda-510k.jpg K181323 - Atlas Gold PTA Dilatation Catheter K181323 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k181479/ 2018-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k181479-ingenia-ambition-s-and-ingenia-fda-510k.jpg K181479 - Ingenia Ambition S and Ingenia Ambition X K181479 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Aug 2018. https://www.510kdatabase.net/k181549/ 2018-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k181549-curiteva-midline-anterior-cervical-fda-510k.jpg K181549 - Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate System) K181549 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Curiteva, LLC. Cleared Aug 2018. https://www.510kdatabase.net/k181796/ 2018-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k181796-freshlook-handling-tint-freshlook-fda-510k.jpg K181796 - FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends, FreshLook Dimensions K181796 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Alcon Laboratories, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k181797/ 2018-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k181797-philips-ct-big-bore-sliding-gantry-fda-510k.jpg K181797 - Philips CT Big Bore Sliding Gantry Configuration K181797 is a FDA 510(k) cleared radiology medical device. Manufacturer: Phillips Medical Systems (Cleveland), Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k181809/ 2018-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k181809-gryphon-anchors-with-dynacord-suture-fda-510k.jpg K181809 - GRYPHON® Anchors with DYNACORD™ Suture K181809 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International SARL. Cleared Aug 2018. https://www.510kdatabase.net/k171547/ 2018-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k171547-qualisys-clinical-system-fda-510k.jpg K171547 - Qualisys Clinical System K171547 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Qualisys AB. Cleared Aug 2018. https://www.510kdatabase.net/k171977/ 2018-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k171977-miplatform-medical-imaging-suite-v30-fda-510k.jpg K171977 - miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer K171977 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hinacom Software and Technology, Ltd.. Cleared Aug 2018. https://www.510kdatabase.net/k173280/ 2018-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k173280-neonatal-conchasmart-breathing-circuits-fda-510k.jpg K173280 - Neonatal ConchaSmart Breathing Circuits K173280 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Teleflexmedical, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k173531/ 2018-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k173531-lockbox-for-perfusor-space-pca-fda-510k.jpg K173531 - Lockbox for Perfusor Space PCA Infusion Pump K173531 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k173869/ 2018-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k173869-med-link-reusable-blood-pressure-cuff-fda-510k.jpg K173869 - Med-link Reusable Blood Pressure Cuff K173869 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Med-Link Electronics Tech Co., Ltd.. Cleared Aug 2018. https://www.510kdatabase.net/k173923/ 2018-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k173923-temporary-cardiac-pacing-wire-fda-510k.jpg K173923 - Temporary Cardiac Pacing Wire K173923 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ethicon, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k180150/ 2018-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k180150-pl8-wrist-reconstruction-plate-fda-510k.jpg K180150 - PL8 Wrist Reconstruction Plate K180150 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Citieffe S.R.L.. Cleared Aug 2018. https://www.510kdatabase.net/k181007/ 2018-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k181007-cianna-medical-savi-scout-reflector-fda-510k.jpg K181007 - Cianna Medical SAVI Scout Reflector and SAVI Scout System K181007 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cianna Medical, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k181094/ 2018-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k181094-polydioxanone-surgical-scaffold-fda-510k.jpg K181094 - Polydioxanone Surgical Scaffold K181094 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lntegra Lifesciences. Cleared Aug 2018. https://www.510kdatabase.net/k181182/ 2018-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k181182-dynacord-suture-fda-510k.jpg K181182 - DYNACORD Suture K181182 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medos International SARL. Cleared Aug 2018. https://www.510kdatabase.net/k181257/ 2018-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k181257-plasmablade-x-30s-plasmablade-x-40-fda-510k.jpg K181257 - PlasmaBlade X 3.0S, PlasmaBlade X 4.0 K181257 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medtronic Advanced Energy. Cleared Aug 2018. https://www.510kdatabase.net/k181432/ 2018-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k181432-provectra-3d-prime-with-vistasoft-fda-510k.jpg K181432 - ProVectra 3D Prime with VistaSoft K181432 is a FDA 510(k) cleared radiology medical device. Manufacturer: Durr Dental SE. Cleared Aug 2018. https://www.510kdatabase.net/k181562/ 2018-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k181562-curiteva-anterior-cervical-plate-system-fda-510k.jpg K181562 - Curiteva Anterior Cervical Plate System K181562 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Curiteva, LLC. Cleared Aug 2018. https://www.510kdatabase.net/k181804/ 2018-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k181804-alphenix-infx-8000cb-v80-fda-510k.jpg K181804 - Alphenix, INFX-8000C/B, V8.0 K181804 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Aug 2018. https://www.510kdatabase.net/k181830/ 2018-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k181830-azurion-r20-fda-510k.jpg K181830 - Azurion R2.0 K181830 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Aug 2018. https://www.510kdatabase.net/k180647/ 2018-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k180647-briefcase-fda-510k.jpg K180647 - BriefCase K180647 is a FDA 510(k) cleared radiology medical device. Manufacturer: Aidoc Medical , Ltd.. Cleared Aug 2018. https://www.510kdatabase.net/k180703/ 2018-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k180703-vita-yz-st-and-vita-yz-xt-fda-510k.jpg K180703 - VITA YZ ST and VITA YZ XT K180703 is a FDA 510(k) cleared dental medical device. Manufacturer: Vita Zahnfabrik H.Rauter GmbH & Co.. Cleared Aug 2018. https://www.510kdatabase.net/k180737/ 2018-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k180737-ultrasound-scanner-system-bk2300-fda-510k.jpg K180737 - Ultrasound Scanner System bk2300 K180737 is a FDA 510(k) cleared radiology medical device. Manufacturer: Bk Medical Aps. Cleared Aug 2018. https://www.510kdatabase.net/k180764/ 2018-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k180764-trojantm-azul-personal-lubricant-h2o-fda-510k.jpg K180764 - TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) K180764 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Church & Dwight Co., Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k180770/ 2018-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k180770-propeller-sensor-for-neohaler-fda-510k.jpg K180770 - Propeller Sensor for Neohaler K180770 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Reciprocal Labs Corporation. Cleared Aug 2018. https://www.510kdatabase.net/k181480/ 2018-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k181480-mmd-tip-fda-510k.jpg K181480 - MMD Tip K181480 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Strata Skin Sciences, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k181666/ 2018-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k181666-smart-one-fda-510k.jpg K181666 - Smart One K181666 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Mir Medical International Research. Cleared Aug 2018. https://www.510kdatabase.net/k181749/ 2018-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k181749-supercable-iso-elastic-cerclage-system-fda-510k.jpg K181749 - SuperCable® Iso-Elastic™ Cerclage System K181749 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Kinamed, Incorporated. Cleared Aug 2018. https://www.510kdatabase.net/k181772/ 2018-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k181772-novostitch-pro-meniscal-repair-system-fda-510k.jpg K181772 - NovoStitch Pro Meniscal Repair System, CTX-A004 (size 0) K181772 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ceterix Orthopaedics, Inc.. Cleared Aug 2018. https://www.510kdatabase.net/k180874/ 2018-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k180874-3m-high-performance-surgical-mask-3m-fda-510k.jpg K180874 - 3M High Performance Surgical Mask, 3M High Performance Surgical Mask with Face Shield K180874 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Healthcare. Cleared Jul 2018. https://www.510kdatabase.net/k181272/ 2018-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k181272-picocare-family-fda-510k.jpg K181272 - Picocare Family K181272 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wontech Co., Ltd.. Cleared Jul 2018. https://www.510kdatabase.net/k181422/ 2018-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k181422-sprint-peripheral-nerve-stimulation-fda-510k.jpg K181422 - SPRINT Peripheral Nerve Stimulation System, Extensa, SPRINT Peripheral Nerve Stimulation System, Endura, SPRINT Clinical Programmer Kit K181422 is a FDA 510(k) cleared neurology medical device. Manufacturer: Spr Therapeutics, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k181708/ 2018-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k181708-mts-plazomicin-0016-256-gml-fda-510k.jpg K181708 - MTS Plazomicin 0.016-256 µg/mL K181708 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Liofilchem S. R. L.. Cleared Jul 2018. https://www.510kdatabase.net/den180008/ 2018-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/den180008-moleculight-ix-fda-510k.jpg DEN180008 - MolecuLight i:X DEN180008 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Moleculight, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k172273/ 2018-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k172273-308nm-excimer-system-fda-510k.jpg K172273 - 308nm Excimer System K172273 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Chongqing Peninsula Medical Technology Co., Ltd.. Cleared Jul 2018. https://www.510kdatabase.net/k180912/ 2018-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k180912-te7te5-diagnostic-ultrasound-system-fda-510k.jpg K180912 - TE7/TE5 Diagnostic Ultrasound System K180912 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Jul 2018. https://www.510kdatabase.net/k181213/ 2018-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k181213-advia-centaur-cmv-igg-and-advia-fda-510k.jpg K181213 - ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control K181213 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k181431/ 2018-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k181431-laser-ureteral-catheter-fda-510k.jpg K181431 - Laser Ureteral Catheter K181431 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Jul 2018. https://www.510kdatabase.net/k181440/ 2018-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k181440-proficient-posterior-cervical-spine-fda-510k.jpg K181440 - Proficient® Posterior Cervical Spine System K181440 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spine Wave, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k181720/ 2018-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k181720-epiphany-cardio-server-mobile-fda-510k.jpg K181720 - Epiphany Cardio Server Mobile K181720 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Epiphany Healthcare, LLC. Cleared Jul 2018. https://www.510kdatabase.net/k181736/ 2018-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k181736-cdc-human-influenza-virus-real-time-rt-fda-510k.jpg K181736 - CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza B Lineage Genotyping Kit, K181736 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Centers For Disease Control and Prevention (Cdc). Cleared Jul 2018. https://www.510kdatabase.net/k181741/ 2018-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k181741-icesphere-15-cx-cryoablation-needle-fda-510k.jpg K181741 - IceSphere 1.5 CX Cryoablation Needle K181741 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Galil Medical , Ltd.. Cleared Jul 2018. https://www.510kdatabase.net/k172616/ 2018-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k172616-pulse-oximeter-fda-510k.jpg K172616 - Pulse Oximeter K172616 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Beijing Safe Heart Technology , Ltd.. Cleared Jul 2018. https://www.510kdatabase.net/k173474/ 2018-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k173474-reticapture-fda-510k.jpg K173474 - RetiCapture K173474 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Ilooda Co,., Ltd.. Cleared Jul 2018. https://www.510kdatabase.net/k173808/ 2018-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k173808-voutia-fda-510k.jpg K173808 - Voutia™ K173808 is a FDA 510(k) cleared dental medical device. Manufacturer: Jeffrey Ward Cash, Dds. Cleared Jul 2018. https://www.510kdatabase.net/k180064/ 2018-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k180064-osteofab-patient-specific-cranial-device-fda-510k.jpg K180064 - OsteoFab Patient Specific Cranial Device K180064 is a FDA 510(k) cleared neurology medical device. Manufacturer: Oxford Performance Materials, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k180076/ 2018-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k180076-ti-3z-interbody-system-fda-510k.jpg K180076 - Ti 3Z Interbody System K180076 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zavation Medical Products, LLC. Cleared Jul 2018. https://www.510kdatabase.net/k180485/ 2018-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k180485-argyle-peritoneal-dialysis-catheter-fda-510k.jpg K180485 - Argyle Peritoneal Dialysis Catheter and Kits, Argyle Presternal Peritoneal Dialysis Catheter and Kits, Argyle Peritoneal Dialysis Accessory Two Part Titanium Luer Adapter, Argyle Adult Peritoneal Dialysis Accessory Titanium Catheter Extender K180485 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Covidien, LLC. Cleared Jul 2018. https://www.510kdatabase.net/k180556/ 2018-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k180556-corelink-foundation-3d-anterior-lumbar-fda-510k.jpg K180556 - Corelink Foundation 3D Anterior Lumbar System K180556 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corelink, LLC. Cleared Jul 2018. https://www.510kdatabase.net/k180580/ 2018-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k180580-medline-renewal-reprocessed-smith-fda-510k.jpg K180580 - Medline ReNewal Reprocessed Smith & Nephew Jet-X External Fixation Devices K180580 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Surgical Instrument Service and Savings, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k180627/ 2018-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k180627-macroduct-advanced-model-3710-fda-510k.jpg K180627 - Macroduct Advanced Model 3710 K180627 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Elitechgroup, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k181156/ 2018-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k181156-panther-fusion-gbs-assay-fda-510k.jpg K181156 - Panther Fusion GBS Assay K181156 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Diagenode. Cleared Jul 2018. https://www.510kdatabase.net/k181184/ 2018-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k181184-oic-intramedullary-nail-system-fda-510k.jpg K181184 - OIC Intramedullary Nail System K181184 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: The Orthopaedic Implant Company. Cleared Jul 2018. https://www.510kdatabase.net/k181395/ 2018-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k181395-universal-cannula-seal-5-12-mm-fda-510k.jpg K181395 - Universal Cannula Seal (5-12 mm) K181395 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k181452/ 2018-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k181452-rct800-fda-510k.jpg K181452 - RCT800 K181452 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ray Co., Ltd.. Cleared Jul 2018. https://www.510kdatabase.net/k181485/ 2018-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k181485-epiq-epiq-5-epiq-7-affiniti-30-fda-510k.jpg K181485 - EPIQ , EPIQ 5, EPIQ 7, Affiniti 30, Affiniti 50 and Affiniti 70 Diagnostic Ultrasound System K181485 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Ultrasound, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k181554/ 2018-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k181554-stowe-pedicle-screw-system-fda-510k.jpg K181554 - Stowe Pedicle Screw System K181554 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Black Box Medical. Cleared Jul 2018. https://www.510kdatabase.net/k181694/ 2018-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k181694-flowtriever-retrievalaspiration-system-fda-510k.jpg K181694 - FlowTriever Retrieval/Aspiration System K181694 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inari Medical. Cleared Jul 2018. https://www.510kdatabase.net/k181763/ 2018-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k181763-fujifilm-ultrasonic-endoscope-fda-510k.jpg K181763 - FUJIFILM Ultrasonic Endoscope K181763 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fujifilm Corporation. Cleared Jul 2018. https://www.510kdatabase.net/k173107/ 2018-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k173107-vios-central-station-monitor-software-fda-510k.jpg K173107 - Vios Central Station Monitor Software, Vios Central Server Software K173107 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vios Medical, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k173656/ 2018-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k173656-arthrex-fibulock-nail-fda-510k.jpg K173656 - Arthrex FibuLock Nail K173656 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k180272/ 2018-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k180272-saniclave-250-fda-510k.jpg K180272 - Saniclave 250 K180272 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Revolutionary Science. Cleared Jul 2018. https://www.510kdatabase.net/k180958/ 2018-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k180958-shockwave-m5-peripheral-intravascular-fda-510k.jpg K180958 - Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable K180958 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shockwave Medical, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k181268/ 2018-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k181268-prolene-polypropylene-3d-patch-fda-510k.jpg K181268 - PROLENE (Polypropylene) 3D Patch K181268 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k181401/ 2018-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k181401-rxsight-insertion-device-fda-510k.jpg K181401 - RxSight Insertion Device K181401 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Rxsight, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k181579/ 2018-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k181579-elens-rigid-gas-permeable-contact-lens-fda-510k.jpg K181579 - eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K K181579 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: E&E Optics, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k181659/ 2018-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k181659-avologi-eneo-fda-510k.jpg K181659 - Avologi ENEO K181659 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Premier North America, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k181699/ 2018-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k181699-level-1-convective-warmer-fda-510k.jpg K181699 - Level 1 Convective Warmer K181699 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Smiths Medical Asd, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k181706/ 2018-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k181706-neuromate-gen-iii-fda-510k.jpg K181706 - neuromate Gen III K181706 is a FDA 510(k) cleared neurology medical device. Manufacturer: Renishaw Mayfield Sarl. Cleared Jul 2018. https://www.510kdatabase.net/k181712/ 2018-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k181712-san-antonio-stopcock-fda-510k.jpg K181712 - San Antonio Stopcock K181712 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Jul 2018. https://www.510kdatabase.net/k181790/ 2018-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k181790-clungene-multi-drug-test-dip-card-fda-510k.jpg K181790 - CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup K181790 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Hangzhou Clongene Biotech Co., Ltd.. Cleared Jul 2018. https://www.510kdatabase.net/k181855/ 2018-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k181855-radialseal-introducer-kit-fda-510k.jpg K181855 - RadialSeal Introducer Kit K181855 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Great Batch Medical. Cleared Jul 2018. https://www.510kdatabase.net/k173837/ 2018-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k173837-rhythmia-hdx-mapping-system-with-fda-510k.jpg K173837 - RHYTHMIA HDx Mapping System (with software Version 2.0) K173837 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Jul 2018. https://www.510kdatabase.net/k173947/ 2018-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k173947-lumbar-interbody-fusion-system-ollif-fda-510k.jpg K173947 - Lumbar Interbody Fusion System (OLLIF) K173947 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Advanced Research Medical, LLC. Cleared Jul 2018. https://www.510kdatabase.net/k180226/ 2018-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k180226-trend-ii-spinal-fixation-system-step-fda-510k.jpg K180226 - TREND II Spinal Fixation System- STEP Series K180226 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paonan Biotech Co., Ltd.. Cleared Jul 2018. https://www.510kdatabase.net/k180407/ 2018-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k180407-smartinhaler-fda-510k.jpg K180407 - Smartinhaler K180407 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Adherium (Nz), Ltd.. Cleared Jul 2018. https://www.510kdatabase.net/k180632/ 2018-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k180632-exactech-equinoxe-small-reverse-fda-510k.jpg K180632 - Exactech Equinoxe Small Reverse Shoulder System K180632 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k180752/ 2018-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k180752-veloxion-system-veloxion-controller-fda-510k.jpg K180752 - Veloxion System, Veloxion Controller Kit, Veloxion Resecting Device Kit, Veloxion Fluid Control Set, Veloxion Saline Pole K180752 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Corinth Medtech, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k180960/ 2018-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k180960-fixit-compositcp-threaded-anchor-system-fda-510k.jpg K180960 - FIXIT / ComposiTCP Threaded Anchor System K180960 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: S.B.M. Sas Sciences For Bio Materials. Cleared Jul 2018. https://www.510kdatabase.net/k181453/ 2018-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k181453-atec-alif-spacer-system-fda-510k.jpg K181453 - ATEC ALIF Spacer System K181453 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k181495/ 2018-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k181495-republic-spine-dark-star-spinal-system-fda-510k.jpg K181495 - Republic Spine Dark Star Spinal System K181495 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Republic Spine, LLC. Cleared Jul 2018. https://www.510kdatabase.net/k181670/ 2018-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k181670-alphenix-infx-8000vb-v80-fda-510k.jpg K181670 - Alphenix, INFX-8000V/B, V8.0 K181670 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Jul 2018. https://www.510kdatabase.net/k172095/ 2018-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k172095-autokeeper-fda-510k.jpg K172095 - Autokeeper K172095 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medexel Co.,Ltd. Cleared Jul 2018. https://www.510kdatabase.net/k172862/ 2018-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k172862-portable-ecg-monitor-ecg3-fda-510k.jpg K172862 - Portable ECG Monitor (ECG3) K172862 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Andon Health Co, Ltd.. Cleared Jul 2018. https://www.510kdatabase.net/k173929/ 2018-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k173929-cipherox-cri-m1-fda-510k.jpg K173929 - CipherOx CRI M1 K173929 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Flashback Technologies, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k173943/ 2018-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k173943-dental-high-speed-handpiece-and-fda-510k.jpg K173943 - Dental High-speed Handpiece and Accessories K173943 is a FDA 510(k) cleared dental medical device. Manufacturer: Microp Technology (Taiwan), Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k180017/ 2018-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k180017-mx40-release-c01-fda-510k.jpg K180017 - MX40 Release C.01 K180017 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Philips Medical Systems. Cleared Jul 2018. https://www.510kdatabase.net/k180115/ 2018-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k180115-twbm-pump-fda-510k.jpg K180115 - TWBM Pump K180115 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Taiwan Biomaterial Co., Ltd.. Cleared Jul 2018. https://www.510kdatabase.net/k180218/ 2018-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k180218-xpert-xpress-flursv-xpert-fda-510k.jpg K180218 - Xpert Xpress Flu/RSV, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV K180218 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Cepheid. Cleared Jul 2018. https://www.510kdatabase.net/k180544/ 2018-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k180544-depuy-synthes-static-staples-fda-510k.jpg K180544 - DePuy Synthes Static Staples K180544 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes USA Products, LLC. Cleared Jul 2018. https://www.510kdatabase.net/k181025/ 2018-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k181025-i-portal-neuro-otologic-test-center-fda-510k.jpg K181025 - I-Portal Neuro Otologic Test Center K181025 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neuro Kinetics, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k181095/ 2018-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k181095-rf-relief-fda-510k.jpg K181095 - RF-Relief K181095 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: El Global Trade, Ltd.. Cleared Jul 2018. https://www.510kdatabase.net/k181178/ 2018-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k181178-s-mini-active-fixture-fda-510k.jpg K181178 - S-mini active Fixture K181178 is a FDA 510(k) cleared dental medical device. Manufacturer: Neobiotech Co., Ltd.. Cleared Jul 2018. https://www.510kdatabase.net/k181339/ 2018-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k181339-altus-spine-pedicle-screw-system-fda-510k.jpg K181339 - Altus Spine Pedicle Screw System K181339 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Altus Partners, LLC. Cleared Jul 2018. https://www.510kdatabase.net/k181399/ 2018-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k181399-firefly-pedicle-screw-navigation-guide-fda-510k.jpg K181399 - FIREFLY® Pedicle Screw Navigation Guide K181399 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Mighty Oak Medical, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k181686/ 2018-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k181686-celerity-20-steam-biological-indicator-fda-510k.jpg K181686 - CELERITY 20 Steam Biological Indicator K181686 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Jul 2018. https://www.510kdatabase.net/k171888/ 2018-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k171888-non-contact-infrared-body-thermometer-fda-510k.jpg K171888 - Non-contact infrared body thermometer K171888 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hetaida Technology Co., Ltd.. Cleared Jul 2018. https://www.510kdatabase.net/k173444/ 2018-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k173444-quantitative-total-extensible-imaging-fda-510k.jpg K173444 - Quantitative Total Extensible Imaging (QTxI) K173444 is a FDA 510(k) cleared radiology medical device. Manufacturer: Aiq Solutions, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k173645/ 2018-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k173645-jasper-spinal-fixation-system-fda-510k.jpg K173645 - JASPER Spinal Fixation System K173645 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Gbs Commonwealth Co., Ltd.. Cleared Jul 2018. https://www.510kdatabase.net/k180518/ 2018-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k180518-gme-linscan-lite-808-laser-system-fda-510k.jpg K180518 - GME LinScan Lite 808 Laser System K180518 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Gme (German Medical Engineering) GmbH. Cleared Jul 2018. https://www.510kdatabase.net/k180854/ 2018-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k180854-voyager-trajectory-array-guide-v-tag-fda-510k.jpg K180854 - Voyager Trajectory Array Guide (V-TAG) K180854 is a FDA 510(k) cleared neurology medical device. Manufacturer: Voyager Therapeutics, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k181083/ 2018-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k181083-stryker-all-peek-knotless-anchor-system-fda-510k.jpg K181083 - Stryker All-PEEK Knotless Anchor System K181083 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker. Cleared Jul 2018. https://www.510kdatabase.net/k181242/ 2018-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k181242-braun-bnt400-no-touch-forehead-fda-510k.jpg K181242 - Braun BNT400 No Touch + Forehead Thermometer K181242 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Kaz USA, Inc., A Helen of Troy Company. Cleared Jul 2018. https://www.510kdatabase.net/k181398/ 2018-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k181398-dv-300-aspirator-fda-510k.jpg K181398 - DV-300 Aspirator K181398 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ding Hwa Co., Ltd.. Cleared Jul 2018. https://www.510kdatabase.net/k173188/ 2018-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k173188-the-graft-natural-bone-substitute-fda-510k.jpg K173188 - The Graft Natural Bone Substitute K173188 is a FDA 510(k) cleared dental medical device. Manufacturer: Purgo Biologics, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k173366/ 2018-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k173366-nicoletone-fda-510k.jpg K173366 - NicoletOne K173366 is a FDA 510(k) cleared neurology medical device. Manufacturer: Natus Neurology Incorporated. Cleared Jul 2018. https://www.510kdatabase.net/k173675/ 2018-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k173675-aquacel-ag-extra-enhanced-hydrofiber-fda-510k.jpg K173675 - AQUACEL Ag+ EXTRA Enhanced Hydrofiber Dressing with Silver and Strengthening Fiber K173675 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Convatec Limited. Cleared Jul 2018. https://www.510kdatabase.net/k173973/ 2018-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k173973-tv-100-fda-510k.jpg K173973 - TV-100 K173973 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Bio-Med Devices, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k180022/ 2018-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k180022-athena-cervical-plate-system-fda-510k.jpg K180022 - Athena Cervical Plate System K180022 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medyssey USA, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k180263/ 2018-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k180263-ecofit-vit-e-acetabular-system-fda-510k.jpg K180263 - EcoFit Vit E Acetabular System K180263 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Implantcast GmbH. Cleared Jul 2018. https://www.510kdatabase.net/k180864/ 2018-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k180864-watchman-truseal-access-system-fda-510k.jpg K180864 - WATCHMAN TruSeal Access System K180864 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific. Cleared Jul 2018. https://www.510kdatabase.net/k180948/ 2018-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k180948-trudi-nav-suction-instruments-fda-510k.jpg K180948 - TruDi NAV Suction Instruments K180948 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Acclarent, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k181017/ 2018-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k181017-free-testosterone-accubind-elisa-test-fda-510k.jpg K181017 - Free Testosterone AccuBind ELISA Test System K181017 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Monobind, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k181382/ 2018-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k181382-guardiantm-burr-hole-cover-system-fda-510k.jpg K181382 - GuardianTM Burr Hole Cover System K181382 is a FDA 510(k) cleared neurology medical device. Manufacturer: St Jude Medical. Cleared Jul 2018. https://www.510kdatabase.net/k181585/ 2018-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k181585-jgh1-core-deccompression-procedure-kit-fda-510k.jpg K181585 - JGH1 Core Deccompression Procedure Kit K181585 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: AgNovos Healthcare USA, LLC. Cleared Jul 2018. https://www.510kdatabase.net/k181626/ 2018-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k181626-digital-diagnostic-mobile-x-ray-system-fda-510k.jpg K181626 - Digital Diagnostic Mobile X-ray System K181626 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Electronics Co., Ltd.. Cleared Jul 2018. https://www.510kdatabase.net/k181629/ 2018-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k181629-gc85a-fda-510k.jpg K181629 - GC85A K181629 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Electronics Co., Ltd.. Cleared Jul 2018. https://www.510kdatabase.net/k181631/ 2018-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k181631-gr40cw-fda-510k.jpg K181631 - GR40CW K181631 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Electronics Co., Ltd.. Cleared Jul 2018. https://www.510kdatabase.net/k181636/ 2018-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k181636-aurora-fda-510k.jpg K181636 - Aurora K181636 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sodium Systems, LLC. Cleared Jul 2018. https://www.510kdatabase.net/k181647/ 2018-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k181647-bandit-guidewire-fda-510k.jpg K181647 - Bandit guidewire K181647 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vascular Solutions, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/den170009/ 2018-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/den170009-bonebridge-fda-510k.jpg DEN170009 - Bonebridge DEN170009 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Med-El Elektromedizinische Geraete GmbH. Cleared Jul 2018. https://www.510kdatabase.net/k170369/ 2018-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k170369-disposable-electrosurgical-pencils-fda-510k.jpg K170369 - Disposable Electrosurgical Pencils K170369 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cathay Manfacturing Corp.. Cleared Jul 2018. https://www.510kdatabase.net/k171566/ 2018-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k171566-atellica-im-high-sensitivity-troponin-fda-510k.jpg K171566 - Atellica IM High-Sensitivity Troponin I (TNIH) K171566 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k172857/ 2018-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k172857-latitud-hip-replacement-system-fda-510k.jpg K172857 - Latitud Hip Replacement System K172857 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Meril Healthcare Pvt. , Ltd.. Cleared Jul 2018. https://www.510kdatabase.net/k173585/ 2018-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k173585-da-vinci-xi-surgical-system-da-vinci-x-fda-510k.jpg K173585 - da Vinci Xi Surgical System, da Vinci X Surgical System K173585 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k173911/ 2018-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k173911-medline-burn-and-wound-dressing-fda-510k.jpg K173911 - Medline Burn and Wound Dressing K173911 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medline Industries, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k180419/ 2018-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k180419-ultrasonic-doppler-model-ym-2t8-fda-510k.jpg K180419 - Ultrasonic Doppler (Model YM-2T8) K180419 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Shenzhen Imdk Medical Technology Co., Ltd.. Cleared Jul 2018. https://www.510kdatabase.net/k180629/ 2018-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k180629-dentiqguide-fda-510k.jpg K180629 - DentiqGuide K180629 is a FDA 510(k) cleared radiology medical device. Manufacturer: 3D Industrial Imaging Co., Ltd.. Cleared Jul 2018. https://www.510kdatabase.net/k180763/ 2018-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k180763-cufflink-implant-system-biocomposite-fda-510k.jpg K180763 - CuffLink Implant System Biocomposite K180763 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Conmed Corporation. Cleared Jul 2018. https://www.510kdatabase.net/k181342/ 2018-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k181342-jgh1-bone-graft-substitute-fda-510k.jpg K181342 - JGH1 Bone Graft Substitute K181342 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: AgNovos Healthcare USA, LLC. Cleared Jul 2018. https://www.510kdatabase.net/k181345/ 2018-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k181345-image-filing-software-navis-ex-fda-510k.jpg K181345 - Image Filing Software NAVIS-EX K181345 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Nidek Co., Ltd.. Cleared Jul 2018. https://www.510kdatabase.net/k181623/ 2018-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k181623-clarifi-imaging-system-fda-510k.jpg K181623 - Clarifi Imaging System K181623 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Modulated Imaging, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k181834/ 2018-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k181834-ultimax-i-drex-ui80-v160-fda-510k.jpg K181834 - Ultimax-i, DREX-UI80 (V1.60) K181834 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Jul 2018. https://www.510kdatabase.net/k170820/ 2018-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k170820-capnograph-and-oximeter-fda-510k.jpg K170820 - Capnograph and Oximeter K170820 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Cmi Health, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k171011/ 2018-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k171011-pentax-medical-vivideo-ent-videoscope-fda-510k.jpg K171011 - PENTAX Medical VIVIDEO ENT Videoscope Solution K171011 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Pentax Medical. Cleared Jul 2018. https://www.510kdatabase.net/k172389/ 2018-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k172389-eptfe-coated-auricular-implant-fda-510k.jpg K172389 - ePTFE-Coated Auricular Implant K172389 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Implantech Associates, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k172653/ 2018-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k172653-power-infuser-fda-510k.jpg K172653 - Power Infuser K172653 is a FDA 510(k) cleared general hospital medical device. Manufacturer: ZOLL Medical Corporation. Cleared Jul 2018. https://www.510kdatabase.net/k173327/ 2018-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k173327-dipus-urine-analysis-test-system-fda-510k.jpg K173327 - DIP/U.S. Urine Analysis Test System K173327 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Healthy.Io, Ltd.. Cleared Jul 2018. https://www.510kdatabase.net/k173487/ 2018-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k173487-carboclear-pedicle-screw-system-fda-510k.jpg K173487 - CarboClear® Pedicle Screw System K173487 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: CarboFix Orthopedics , Ltd.. Cleared Jul 2018. https://www.510kdatabase.net/k173762/ 2018-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k173762-angiodynamics-inc-soft-vu-and-mariner-fda-510k.jpg K173762 - AngioDynamics, Inc. Soft-Vu and Mariner Angiographic Catheters K173762 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: AngioDynamics, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k173829/ 2018-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k173829-neolsd-msms-kit-fda-510k.jpg K173829 - NeoLSD MSMS kit K173829 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Wallac Oy, A Subsidiary of Perkinelmer. Cleared Jul 2018. https://www.510kdatabase.net/k180027/ 2018-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k180027-accusyte-3d-fiducial-marker-fda-510k.jpg K180027 - ACCUSYTE 3D Fiducial Marker K180027 is a FDA 510(k) cleared radiology medical device. Manufacturer: Radiation Products, LLC. Cleared Jul 2018. https://www.510kdatabase.net/k180784/ 2018-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k180784-asahi-ptca-guide-wire-asahi-gladius-fda-510k.jpg K180784 - ASAHI PTCA Guide Wire ASAHI Gladius Mongo 14, ASAHI Gladius Mongo 14 ES K180784 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Asahi Intecc Co., Ltd.. Cleared Jul 2018. https://www.510kdatabase.net/k180977/ 2018-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k180977-karl-storz-new-generation-trocars-fda-510k.jpg K180977 - KARL STORZ New Generation Trocars K180977 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k181014/ 2018-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k181014-tritanium-pl-cage-fda-510k.jpg K181014 - Tritanium PL Cage K181014 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Spine. Cleared Jul 2018. https://www.510kdatabase.net/k181015/ 2018-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k181015-braun-bfh175-infrared-forehead-fda-510k.jpg K181015 - Braun BFH175 Infrared Forehead Thermometer K181015 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Kaz USA, Inc., A Helen of Troy Company. Cleared Jul 2018. https://www.510kdatabase.net/k181062/ 2018-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k181062-ultra-facial-toning-system-fda-510k.jpg K181062 - Ultra Facial Toning System K181062 is a FDA 510(k) cleared neurology medical device. Manufacturer: Micro Current Technology, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k181079/ 2018-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k181079-seaspine-regatta-lateral-system-fda-510k.jpg K181079 - SeaSpine Regatta Lateral System K181079 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared Jul 2018. https://www.510kdatabase.net/k181189/ 2018-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k181189-atlantis-conus-structure-fda-510k.jpg K181189 - ATLANTIS Conus Structure K181189 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona. Cleared Jul 2018. https://www.510kdatabase.net/k181376/ 2018-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k181376-arietta-65-fda-510k.jpg K181376 - ARIETTA 65 K181376 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hitachi Healthcare Americas Corporation. Cleared Jul 2018. https://www.510kdatabase.net/k171272/ 2018-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k171272-cook-swartz-doppler-flow-probe-fda-510k.jpg K171272 - Cook-Swartz Doppler Flow Probe K171272 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cook Incorporated. Cleared Jul 2018. https://www.510kdatabase.net/k173654/ 2018-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k173654-ureteral-dilator-sets-ureteral-dilators-fda-510k.jpg K173654 - Ureteral Dilator Sets, Ureteral Dilators K173654 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Jul 2018. https://www.510kdatabase.net/k173797/ 2018-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k173797-stat-profile-prime-plus-analyzer-system-fda-510k.jpg K173797 - Stat Profile Prime Plus Analyzer System K173797 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Nova Biomedical Corporation. Cleared Jul 2018. https://www.510kdatabase.net/k173968/ 2018-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k173968-straumann-variobase-for-bridgebar-fda-510k.jpg K173968 - Straumann Variobase for Bridge/Bar Cylindrical K173968 is a FDA 510(k) cleared dental medical device. Manufacturer: Institut Straumann AG. Cleared Jul 2018. https://www.510kdatabase.net/k180269/ 2018-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k180269-cadwell-apollo-system-fda-510k.jpg K180269 - Cadwell Apollo System K180269 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cadwell Industries, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k180348/ 2018-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k180348-field-orthopaedics-micro-screw-system-fda-510k.jpg K180348 - Field Orthopaedics Micro Screw System K180348 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Field Orthopaedics Pty, Ltd.. Cleared Jul 2018. https://www.510kdatabase.net/k180915/ 2018-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k180915-sonicision-reusable-sterilization-tray-fda-510k.jpg K180915 - Sonicision Reusable Sterilization Tray K180915 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Covidien. Cleared Jul 2018. https://www.510kdatabase.net/k181030/ 2018-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k181030-rubicon-lumbar-interbody-fusion-system-fda-510k.jpg K181030 - Rubicon Lumbar Interbody Fusion System K181030 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Rubicon Spine, LLC. Cleared Jul 2018. https://www.510kdatabase.net/k181375/ 2018-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k181375-apex-femoral-nailing-system-fda-510k.jpg K181375 - Apex Femoral Nailing System K181375 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthoxel. Cleared Jul 2018. https://www.510kdatabase.net/k180151/ 2018-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k180151-mc3-jugular-dual-lumen-catheter-fda-510k.jpg K180151 - MC3 Jugular Dual Lumen Catheter K180151 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Mc3 Incorporated. Cleared Jul 2018. https://www.510kdatabase.net/k180526/ 2018-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k180526-eidon-fa-fda-510k.jpg K180526 - EIDON FA K180526 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Centervue S.P.A.. Cleared Jul 2018. https://www.510kdatabase.net/k180534/ 2018-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k180534-philips-intellivue-guardiansoftware-fda-510k.jpg K180534 - Philips IntelliVue GuardianSoftware K180534 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Philips Medizin Systeme Boeblingen GmbH. Cleared Jul 2018. https://www.510kdatabase.net/k181002/ 2018-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k181002-atellica-im-brahms-procalcitonin-pct-fda-510k.jpg K181002 - Atellica IM BRAHMS Procalcitonin (PCT) K181002 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k181016/ 2018-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k181016-welch-allyn-retinavue-network-ref-fda-510k.jpg K181016 - Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System K181016 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Welch Allyn, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k181019/ 2018-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k181019-diode-laser-system-fda-510k.jpg K181019 - Diode Laser System K181019 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Guangzhou Huafei Tongda Technology Co., Ltd.. Cleared Jul 2018. https://www.510kdatabase.net/k181115/ 2018-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k181115-cxha-peek-cervical-ibf-system-fda-510k.jpg K181115 - CxHA PEEK Cervical IBF System K181115 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Innovasis, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k181300/ 2018-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k181300-embosphere-microspheres-fda-510k.jpg K181300 - Embosphere Microspheres K181300 is a FDA 510(k) cleared neurology medical device. Manufacturer: Biosphere Medical, S.A.. Cleared Jul 2018. https://www.510kdatabase.net/k181600/ 2018-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k181600-pathloc-si-joint-fusion-system-fda-510k.jpg K181600 - PathLoc-SI Joint Fusion System K181600 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: L & K Biomed Co., Ltd.. Cleared Jul 2018. https://www.510kdatabase.net/k181029/ 2018-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k181029-solana-bordetella-complete-assay-fda-510k.jpg K181029 - Solana Bordetella Complete Assay K181029 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Quidel Corporation. Cleared Jul 2018. https://www.510kdatabase.net/k171550/ 2018-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k171550-sterile-latex-surgical-gloves-powder-fda-510k.jpg K171550 - Sterile Latex Surgical Gloves, Powder Free K171550 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sanrea Healthcare Products Pvt, Ltd.. Cleared Jul 2018. https://www.510kdatabase.net/k171880/ 2018-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k171880-irraflow-cns-system-fda-510k.jpg K171880 - IRRAflow CNS System K171880 is a FDA 510(k) cleared neurology medical device. Manufacturer: Irras, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k172440/ 2018-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k172440-solax-electric-scooter-models-s302121-fda-510k.jpg K172440 - Solax Electric Scooter, Models: S302121, S302131, S302141, S302151 K172440 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Dongguan Prestige Sporting Goods., Ltd.. Cleared Jul 2018. https://www.510kdatabase.net/k172987/ 2018-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k172987-surgical-gown-ae1001-ae2001-ae3001-fda-510k.jpg K172987 - Surgical gown (AE1001, AE2001, AE3001) K172987 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Gmax Industries, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k173340/ 2018-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k173340-yikang-latex-foley-catheter-fda-510k.jpg K173340 - Yikang Latex Foley Catheter K173340 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Jiangxi Yikang Medical Instrument Group Co., Ltd.. Cleared Jul 2018. https://www.510kdatabase.net/k173556/ 2018-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k173556-injection-screw-fda-510k.jpg K173556 - Injection Screw K173556 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biedermann Medtech, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k173909/ 2018-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k173909-dimension-hemoglobin-a1c-assay-fda-510k.jpg K173909 - Dimension Hemoglobin A1c Assay K173909 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k180011/ 2018-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k180011-pulmonx-chartis-tablet-console-fda-510k.jpg K180011 - Pulmonx Chartis Tablet Console K180011 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Pulmonx Corporation. Cleared Jul 2018. https://www.510kdatabase.net/k180654/ 2018-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k180654-pinxel-rf-system-fda-510k.jpg K180654 - PINXEL-RF system K180654 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Rohrer Aesthetics, LLC. Cleared Jul 2018. https://www.510kdatabase.net/k180655/ 2018-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k180655-viking-lumbar-polyaxial-screw-system-fda-510k.jpg K180655 - Viking Lumbar Polyaxial Screw System K180655 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Presidio Surgical. Cleared Jul 2018. https://www.510kdatabase.net/k180673/ 2018-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k180673-normandy-vbr-system-fda-510k.jpg K180673 - Normandy VBR System K180673 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zavation Medical Products, LLC. Cleared Jul 2018. https://www.510kdatabase.net/k181063/ 2018-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k181063-kestrel-buttress-plate-system-fda-510k.jpg K181063 - Kestrel™ Buttress Plate System K181063 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Innovasis, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k181134/ 2018-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k181134-gum-hydral-dry-mouth-oral-gel-gum-fda-510k.jpg K181134 - G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral Spray K181134 is a FDA 510(k) cleared dental medical device. Manufacturer: Sunstar Americas, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k181556/ 2018-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k181556-elia-m2-immunoassay-fda-510k.jpg K181556 - EliA M2 Immunoassay K181556 is a FDA 510(k) cleared immunology medical device. Manufacturer: Phadia AB. Cleared Jul 2018. https://www.510kdatabase.net/k181565/ 2018-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k181565-aquarius-8600-digital-radiography-sensor-fda-510k.jpg K181565 - Aquarius 8600 Digital Radiography Sensor K181565 is a FDA 510(k) cleared radiology medical device. Manufacturer: Biokinemetrics, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k181586/ 2018-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k181586-tinnitus-sound-generator-module-fda-510k.jpg K181586 - Tinnitus Sound Generator Module K181586 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: GN Hearing A/S. Cleared Jul 2018. https://www.510kdatabase.net/k171274/ 2018-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k171274-advia-centaur-high-sensitivity-fda-510k.jpg K171274 - ADVIA Centaur High-Sensitivity Troponin I (TNIH) K171274 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k172874/ 2018-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k172874-infrared-thermometer-fda-510k.jpg K172874 - Infrared Thermometer K172874 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen Jiacom Technology CO ., Ltd.. Cleared Jul 2018. https://www.510kdatabase.net/k173206/ 2018-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k173206-sekure-hba1c-assay-fda-510k.jpg K173206 - SEKURE HbA1c Assay K173206 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sekisui Diagnostics P.E.I., Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k173511/ 2018-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k173511-activecare-td-4121-blood-glucose-fda-510k.jpg K173511 - ActiveCare TD-4121 Blood Glucose Monitoring System K173511 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Taidoc Technology Corporation. Cleared Jul 2018. https://www.510kdatabase.net/k173627/ 2018-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k173627-medline-renewal-reprocessed-sonicision-fda-510k.jpg K173627 - Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector K173627 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Surgical Instrument Service and Savings, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k180552/ 2018-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k180552-modified-novy-cornual-cannulation-set-fda-510k.jpg K180552 - Modified Novy Cornual Cannulation Set K180552 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Cook Incorporated. Cleared Jul 2018. https://www.510kdatabase.net/k180575/ 2018-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k180575-thunderbeat-5-mm-20-cm-front-actuated-fda-510k.jpg K180575 - THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type X, THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type X K180575 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Jul 2018. https://www.510kdatabase.net/k180613/ 2018-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k180613-estelite-universal-flow-fda-510k.jpg K180613 - Estelite Universal Flow K180613 is a FDA 510(k) cleared dental medical device. Manufacturer: Tokuyama Dental Corporation. Cleared Jul 2018. https://www.510kdatabase.net/k180695/ 2018-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k180695-fbc-921-alif-fda-510k.jpg K180695 - FBC 921 (ALIF) K180695 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Fbc Device Aps. Cleared Jul 2018. https://www.510kdatabase.net/k181011/ 2018-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k181011-aim2-fda-510k.jpg K181011 - AIM2 K181011 is a FDA 510(k) cleared dental medical device. Manufacturer: GC America, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k181043/ 2018-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k181043-statstrip-glucose-hospital-meter-system-fda-510k.jpg K181043 - StatStrip Glucose Hospital Meter System K181043 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Nova Biomedical Corporation. Cleared Jul 2018. https://www.510kdatabase.net/k181276/ 2018-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k181276-conod-enteral-feeding-sets-fda-510k.jpg K181276 - CONOD Enteral Feeding Sets K181276 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Conod Medical Co., Limited. Cleared Jul 2018. https://www.510kdatabase.net/k181287/ 2018-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k181287-catalyst-csr-shoulder-system-fda-510k.jpg K181287 - Catalyst CSR Shoulder System K181287 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Catalyst Orthoscience, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k172543/ 2018-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k172543-high-speed-turbine-handpieces-for-fda-510k.jpg K172543 - High-speed Turbine Handpieces for Single Use K172543 is a FDA 510(k) cleared dental medical device. Manufacturer: Beijing Dongbo Dental Handpiece Co., Ltd.. Cleared Jul 2018. https://www.510kdatabase.net/k173486/ 2018-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k173486-ntu-usb-ultrasound-usb-box-fda-510k.jpg K173486 - NTU-USB Ultrasound USB Box K173486 is a FDA 510(k) cleared radiology medical device. Manufacturer: National Taiwan University. Cleared Jul 2018. https://www.510kdatabase.net/k173631/ 2018-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k173631-intelli-c-fda-510k.jpg K173631 - Intelli-C K173631 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nrt X-Ray A/S. Cleared Jul 2018. https://www.510kdatabase.net/k173801/ 2018-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k173801-transcranial-doppler-ultrasound-system-fda-510k.jpg K173801 - Transcranial Doppler Ultrasound System K173801 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Delica Medical Equipment Co., Ltd.. Cleared Jul 2018. https://www.510kdatabase.net/k173881/ 2018-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k173881-unifine-safecontrol-5mm-x-30g-unifine-fda-510k.jpg K173881 - Unifine SafeControl 5mm x 30G, Unifine SafeControl 8mm x 30G K173881 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Owen Mumford, Ltd.. Cleared Jul 2018. https://www.510kdatabase.net/k173969/ 2018-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k173969-medicalgorithmics-unified-cardiac-fda-510k.jpg K173969 - Medicalgorithmics Unified Cardiac Rehabilitation System K173969 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medicalgorithmics S.A.. Cleared Jul 2018. https://www.510kdatabase.net/k180024/ 2018-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k180024-salvation-midfoot-nail-fda-510k.jpg K180024 - SALVATION Midfoot Nail K180024 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jul 2018. https://www.510kdatabase.net/k180314/ 2018-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k180314-infrared-thermometer-fda-510k.jpg K180314 - Infrared Thermometer K180314 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Xuzhou Yongkang Electronic Science Technology Co., Ltd.. Cleared Jul 2018. https://www.510kdatabase.net/k180725/ 2018-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k180725-aspire-introducer-needle-fda-510k.jpg K180725 - Aspire Introducer Needle K180725 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Aspire Bariatrics, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k180730/ 2018-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k180730-invision-total-ankle-revision-system-fda-510k.jpg K180730 - INVISION Total Ankle Revision System K180730 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jul 2018. https://www.510kdatabase.net/k180816/ 2018-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k180816-ziehm-rfd-3d-tracker-fda-510k.jpg K180816 - Ziehm RFD 3D Tracker K180816 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Navigation. Cleared Jul 2018. https://www.510kdatabase.net/k180963/ 2018-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k180963-roccia-alif-roccia-tlif-fda-510k.jpg K180963 - ROCCIA ALIF, ROCCIA TLIF K180963 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Silony Medical GmbH. Cleared Jul 2018. https://www.510kdatabase.net/k180967/ 2018-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k180967-dental-diode-laser-system-fda-510k.jpg K180967 - Dental Diode Laser System K180967 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lazon Medical Laser Co., Ltd.. Cleared Jul 2018. https://www.510kdatabase.net/k181523/ 2018-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k181523-syneron-co2re-system-fda-510k.jpg K181523 - Syneron CO2RE System K181523 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Syneron-Candela Corp. Cleared Jul 2018. https://www.510kdatabase.net/k181697/ 2018-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k181697-16ch-foot-ankle-speeder-fda-510k.jpg K181697 - 16ch Foot/ Ankle SPEEDER K181697 is a FDA 510(k) cleared radiology medical device. Manufacturer: Quality Electrodynamics, LLC. Cleared Jul 2018. https://www.510kdatabase.net/k172991/ 2018-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k172991-advanced-dental-applicance-fda-510k.jpg K172991 - Advanced Dental Applicance K172991 is a FDA 510(k) cleared dental medical device. Manufacturer: Dasoft Partners. Cleared Jul 2018. https://www.510kdatabase.net/k173039/ 2018-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k173039-trumatch-cmf-titanium-3d-printed-implant-fda-510k.jpg K173039 - TruMatch CMF Titanium 3D Printed Implant K173039 is a FDA 510(k) cleared dental medical device. Manufacturer: Materialise NV. Cleared Jul 2018. https://www.510kdatabase.net/k173274/ 2018-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k173274-ceevra-reveal-20-fda-510k.jpg K173274 - Ceevra Reveal 2.0 K173274 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ceevra, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k180289/ 2018-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k180289-3d-bolus-software-fda-510k.jpg K180289 - 3D Bolus Software K180289 is a FDA 510(k) cleared radiology medical device. Manufacturer: 3D Bolus, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k180697/ 2018-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k180697-pseudo-patient-fda-510k.jpg K180697 - Pseudo-Patient K180697 is a FDA 510(k) cleared radiology medical device. Manufacturer: Rtsafe, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k180900/ 2018-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k180900-led-light-therapy-device-fda-510k.jpg K180900 - LED Light Therapy Device K180900 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Uvbiotek, LLC. Cleared Jul 2018. https://www.510kdatabase.net/k180970/ 2018-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k180970-disposable-guides-kdng00-fda-510k.jpg K180970 - Disposable guides KDNG00 K180970 is a FDA 510(k) cleared radiology medical device. Manufacturer: Koelis. Cleared Jul 2018. https://www.510kdatabase.net/k181201/ 2018-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k181201-synermed-ise-reagents-fda-510k.jpg K181201 - Synermed ISE Reagents K181201 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Infrared Laboratory Systems, LLC (Dba Synermed). Cleared Jul 2018. https://www.510kdatabase.net/k181244/ 2018-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k181244-zavation-cervical-plate-system-fda-510k.jpg K181244 - Zavation Cervical Plate System K181244 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zavation Medical Products, LLC. Cleared Jul 2018. https://www.510kdatabase.net/k181246/ 2018-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k181246-zavation-ibf-system-fda-510k.jpg K181246 - Zavation IBF System K181246 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zavation Medical Products, LLC. Cleared Jul 2018. https://www.510kdatabase.net/k181572/ 2018-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k181572-workflow-box-fda-510k.jpg K181572 - Workflow Box K181572 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mirada Medical, Ltd.. Cleared Jul 2018. https://www.510kdatabase.net/k181574/ 2018-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k181574-uscan-fda-510k.jpg K181574 - Uscan K181574 is a FDA 510(k) cleared radiology medical device. Manufacturer: EchoNous, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k181700/ 2018-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k181700-hardydisk-ast-plazomicin-30ug-plz30-fda-510k.jpg K181700 - HardyDisk AST Plazomicin 30ug (PLZ30) K181700 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Hardy Diagnostics. Cleared Jul 2018. https://www.510kdatabase.net/k173562/ 2018-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k173562-straumann-jason-membrane-fda-510k.jpg K173562 - Straumann Jason Membrane K173562 is a FDA 510(k) cleared dental medical device. Manufacturer: Institut Straumann AG. Cleared Jul 2018. https://www.510kdatabase.net/k180798/ 2018-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k180798-prime-acetabular-cup-system-fda-510k.jpg K180798 - Prime Acetabular Cup System K180798 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Microport Orthopedics, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k180923/ 2018-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k180923-personal-lubricating-jelly-fda-510k.jpg K180923 - Personal Lubricating Jelly K180923 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Perrigo New York, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k180930/ 2018-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k180930-empowr-vvc-tibial-insert-fda-510k.jpg K180930 - EMPOWR VVC TIBIAL INSERT K180930 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Encore Medical, L.P.. Cleared Jul 2018. https://www.510kdatabase.net/k181261/ 2018-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k181261-curiteva-cervical-interbody-fusion-fda-510k.jpg K181261 - Curiteva Cervical Interbody Fusion System K181261 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Curiteva, LLC. Cleared Jul 2018. https://www.510kdatabase.net/k181522/ 2018-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k181522-pentax-medical-ed-3490tk-video-fda-510k.jpg K181522 - PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope K181522 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Pentax of America, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k181547/ 2018-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k181547-fibroscan-family-of-products-models-fda-510k.jpg K181547 - FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+) K181547 is a FDA 510(k) cleared radiology medical device. Manufacturer: Echosens. Cleared Jul 2018. https://www.510kdatabase.net/k172971/ 2018-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k172971-bmls16-1-fda-510k.jpg K172971 - BMLS16-1 K172971 is a FDA 510(k) cleared neurology medical device. Manufacturer: Biomedical Life Systems, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k173766/ 2018-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k173766-pf-nitrile-exam-glove-with-ph-coating-fda-510k.jpg K173766 - PF Nitrile Exam Glove with pH coating, Black-Gray Color, Tested for Use with Chemo Drugs K173766 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shen Wei (Usa), Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k172694/ 2018-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k172694-sterile-disposable-syringes-fda-510k.jpg K172694 - Sterile Disposable Syringes K172694 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenyang Mastech Medical Device Co., Ltd.. Cleared Jul 2018. https://www.510kdatabase.net/k173019/ 2018-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k173019-gynecare-tvt-reusable-introducer-fda-510k.jpg K173019 - GYNECARE TVT Reusable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide, GYNECARE TVT EXACT Continence System Trocar K173019 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ethicon, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k173659/ 2018-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k173659-howell-dash-extraction-balloon-with-fda-510k.jpg K173659 - Howell D.A.S.H Extraction Balloon with Multiple Sizing K173659 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Wilson-Cook Medical, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k173776/ 2018-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k173776-biolox-delta-option-and-extra-long-heads-fda-510k.jpg K173776 - BIOLOX delta Option and Extra-long Heads K173776 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Microport Orthopedics, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k173927/ 2018-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k173927-elecsys-brahms-pct-fda-510k.jpg K173927 - Elecsys BRAHMS PCT K173927 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Diagnostics. Cleared Jul 2018. https://www.510kdatabase.net/k173970/ 2018-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k173970-materialise-pka-guide-system-fda-510k.jpg K173970 - Materialise PKA Guide System K173970 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Materialise NV. Cleared Jul 2018. https://www.510kdatabase.net/k180515/ 2018-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k180515-gammatile-fda-510k.jpg K180515 - GammaTile K180515 is a FDA 510(k) cleared radiology medical device. Manufacturer: Isoray Medical, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k180590/ 2018-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k180590-tyber-medical-pt-interbody-spacer-system-fda-510k.jpg K180590 - Tyber Medical PT Interbody Spacer System K180590 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tyber Medical, LLC. Cleared Jul 2018. https://www.510kdatabase.net/k180755/ 2018-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k180755-vail-alif-buttress-plate-system-fda-510k.jpg K180755 - Vail ALIF Buttress Plate System K180755 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Evolution Spine, LLC. Cleared Jul 2018. https://www.510kdatabase.net/k180868/ 2018-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k180868-nasal-biliary-drainage-set-liguory-fda-510k.jpg K180868 - Nasal Biliary Drainage Set, Liguory Nasal Biliary Drainage Set, Nagaraja Nasal Biliary Drainage Set, Leung Nasal Biliary Drainage Set K180868 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Ireland. Cleared Jul 2018. https://www.510kdatabase.net/k181092/ 2018-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k181092-chromid-carba-agar-carb-fda-510k.jpg K181092 - CHROMID CARBA agar (CARB) K181092 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Biomerieux S.A.. Cleared Jul 2018. https://www.510kdatabase.net/k181139/ 2018-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k181139-olympic-posterior-spinal-fixation-system-fda-510k.jpg K181139 - OLYMPIC Posterior Spinal Fixation System K181139 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Astura Medical, LLC. Cleared Jul 2018. https://www.510kdatabase.net/k181327/ 2018-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k181327-inpen-dose-calculator-fda-510k.jpg K181327 - InPen Dose Calculator K181327 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Companion Medical, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k181350/ 2018-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k181350-astra-oct-spine-system-fda-510k.jpg K181350 - ASTRA-OCT Spine System K181350 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinecraft, LLC. Cleared Jul 2018. https://www.510kdatabase.net/k181499/ 2018-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k181499-dri-cocaine-metabolite-assay-fda-510k.jpg K181499 - DRI Cocaine Metabolite Assay K181499 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Microgenics Corporation. Cleared Jul 2018. https://www.510kdatabase.net/k181509/ 2018-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k181509-endorate-valve-sets-fda-510k.jpg K181509 - Endorate Valve Sets K181509 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Smartdata Suzhou Co., Ltd.. Cleared Jul 2018. https://www.510kdatabase.net/k161085/ 2018-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k161085-nitrile-patient-examination-powder-fda-510k.jpg K161085 - Nitrile Patient Examination Powder Free Glove, Textured, Black K161085 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Multisafe Sdn. Bhd.. Cleared Jul 2018. https://www.510kdatabase.net/k172778/ 2018-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k172778-checkmyheart-plus-fda-510k.jpg K172778 - CheckMyHeart Plus K172778 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Dailycare Biomedical, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k173277/ 2018-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k173277-asahi-ptca-guide-wire-asahi-sion-black-fda-510k.jpg K173277 - ASAHI PTCA Guide Wire ASAHI SION black K173277 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Asahi Intecc Co., Ltd.. Cleared Jul 2018. https://www.510kdatabase.net/k173359/ 2018-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k173359-fractional-co2-surgical-laser-system-fda-510k.jpg K173359 - Fractional CO2 Surgical Laser System K173359 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ami, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k173721/ 2018-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k173721-sureform-60-and-sureform-60-reloads-fda-510k.jpg K173721 - SureForm 60 and SureForm 60 Reloads K173721 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical. Cleared Jul 2018. https://www.510kdatabase.net/k180018/ 2018-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k180018-disposable-hot-biopsy-forceps-fda-510k.jpg K180018 - Disposable Hot Biopsy Forceps K180018 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Micro-Tech (Nanjing) Co., Ltd.. Cleared Jul 2018. https://www.510kdatabase.net/k181044/ 2018-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k181044-400um-perforator-and-accessory-vein-fda-510k.jpg K181044 - 400um Perforator and Accessory Vein Ablation Kit K181044 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: AngioDynamics, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k181175/ 2018-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k181175-12f-tri-flow-triple-lumen-catheter-fda-510k.jpg K181175 - 12F Tri-Flow Triple Lumen Catheter K181175 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medical Components, Inc. (dba MedComp). Cleared Jul 2018. https://www.510kdatabase.net/k181493/ 2018-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k181493-filmarray-blood-culture-identification-fda-510k.jpg K181493 - FilmArray Blood Culture Identification (BCID) Panel K181493 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Biofire Diagnostics, LLC. Cleared Jul 2018. https://www.510kdatabase.net/k180705/ 2018-07-04 monthly 0.5 https://www.510kdatabase.net/og-image/k180705-riptide-aspiration-system-react-68-fda-510k.jpg K180705 - Riptide Aspiration System React 68 Catheter K180705 is a FDA 510(k) cleared neurology medical device. Manufacturer: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. Cleared Jul 2018. https://www.510kdatabase.net/k180715/ 2018-07-04 monthly 0.5 https://www.510kdatabase.net/og-image/k180715-react-68-catheter-fda-510k.jpg K180715 - React 68 Catheter K180715 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. Cleared Jul 2018. https://www.510kdatabase.net/k172952/ 2018-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k172952-figaro-crowns-anterior-crown-kit-fda-510k.jpg K172952 - Figaro Crowns Anterior Crown Kit, Figaro Crowns Posterior Crown Kit K172952 is a FDA 510(k) cleared dental medical device. Manufacturer: Figaro Crowns, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k173679/ 2018-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k173679-pentax-medical-epk-i7010-video-fda-510k.jpg K173679 - PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes K173679 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Pentax of America, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k180367/ 2018-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k180367-ureterorenoscope-system-fda-510k.jpg K180367 - Ureterorenoscope System K180367 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Shanghai AnQing Medical Instrument Co., Ltd.. Cleared Jul 2018. https://www.510kdatabase.net/k180936/ 2018-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k180936-etest-telavancin-tla-0002-32-ugml-fda-510k.jpg K180936 - ETEST Telavancin (TLA) (0.002-32 ug/mL) K180936 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Biomerieux S.A.. Cleared Jul 2018. https://www.510kdatabase.net/k181193/ 2018-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k181193-periview-flex-fda-510k.jpg K181193 - PeriView FLEX K181193 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Olympus Surgical Technologies America. Cleared Jul 2018. https://www.510kdatabase.net/k181526/ 2018-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k181526-xrpad2-4343-hwc-m-flat-panel-detector-fda-510k.jpg K181526 - XRpad2 4343 HWC-M Flat Panel Detector K181526 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varex Imaging Corporation. Cleared Jul 2018. https://www.510kdatabase.net/k173276/ 2018-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k173276-medline-sterile-water-usp-and-medline-fda-510k.jpg K173276 - Medline Sterile Water USP and Medline Sterile 0.9% Normal Saline USP K173276 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medline Industries, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k173864/ 2018-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k173864-peekplus-interbody-fusion-device-fda-510k.jpg K173864 - Peekplus® Interbody Fusion Device K173864 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Vallum Corporation. Cleared Jul 2018. https://www.510kdatabase.net/k173868/ 2018-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k173868-serenity-body-position-sensor-serenity-fda-510k.jpg K173868 - Serenity Body Position Sensor, Serenity RIP Sensors K173868 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neurotronics, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k180910/ 2018-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k180910-ultrapro-mesh-and-ultrapro-advanced-fda-510k.jpg K180910 - ULTRAPRO Mesh and ULTRAPRO ADVANCED K180910 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k171414/ 2018-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k171414-qeeg-pro-fda-510k.jpg K171414 - qEEG-Pro K171414 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainmaster Technologies, Inc.. Cleared Jul 2018. https://www.510kdatabase.net/k171197/ 2018-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k171197-zuga-dental-implant-system-fda-510k.jpg K171197 - Zuga Dental Implant System K171197 is a FDA 510(k) cleared dental medical device. Manufacturer: Zuga Medical, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k172556/ 2018-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k172556-tubeclear-system-fda-510k.jpg K172556 - TubeClear System K172556 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Actuated Medical, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k173164/ 2018-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k173164-ecolab-pou-water-filter-fda-510k.jpg K173164 - Ecolab POU Water Filter K173164 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ecolab, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k173815/ 2018-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k173815-allergan-botox-needle-electrode-fda-510k.jpg K173815 - Allergan Botox Needle Electrode K173815 is a FDA 510(k) cleared neurology medical device. Manufacturer: Natus Manufacturing Limited. Cleared Jun 2018. https://www.510kdatabase.net/k180021/ 2018-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k180021-proton-positioing-and-immobilization-fda-510k.jpg K180021 - Proton Positioing and Immobilization Devices K180021 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medtec Inc Dba Civco Medical Solutions and Civco Radiotherap. Cleared Jun 2018. https://www.510kdatabase.net/k180038/ 2018-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k180038-nuvasive-pulse-system-fda-510k.jpg K180038 - NuVasive Pulse System K180038 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Jun 2018. https://www.510kdatabase.net/k180134/ 2018-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k180134-ensizor-monopolar-endoscopic-scissors-fda-510k.jpg K180134 - Ensizor Monopolar Endoscopic Scissors K180134 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Slater Endoscopy, LLC. Cleared Jun 2018. https://www.510kdatabase.net/k180389/ 2018-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k180389-venera-508-deep-vein-thrombosis-dvt-fda-510k.jpg K180389 - Venera 508 Deep Vein Thrombosis (DVT) Prevention System K180389 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Suzhou Minhua Medical Apparatus Supplies Co., Ltd.. Cleared Jun 2018. https://www.510kdatabase.net/k180481/ 2018-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k180481-servator-b-salf-solution-fda-510k.jpg K180481 - Servator B SALF Solution K180481 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: S.A.L.F. Spa. Cleared Jun 2018. https://www.510kdatabase.net/k181068/ 2018-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k181068-creo-stabilization-system-revere-fda-510k.jpg K181068 - CREO® Stabilization System, REVERE® Stabilization System K181068 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k181232/ 2018-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k181232-largan-55-uv-ocufilcon-d-daily-wear-fda-510k.jpg K181232 - Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia K181232 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Largan Medical Co., Ltd.. Cleared Jun 2018. https://www.510kdatabase.net/k181410/ 2018-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k181410-motocliphimax-implant-system-fda-510k.jpg K181410 - MotoCLIP/HiMAX Implant System K181410 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Crossroads Extremity Systems, LLC. Cleared Jun 2018. https://www.510kdatabase.net/k172457/ 2018-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k172457-deltex-medical-cardioq-edm-deltex-fda-510k.jpg K172457 - Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDM K172457 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Deltex Medical Limited. Cleared Jun 2018. https://www.510kdatabase.net/k173116/ 2018-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k173116-kj-zirconia-implant-system-fda-510k.jpg K173116 - KJ ZIRCONIA Implant System K173116 is a FDA 510(k) cleared dental medical device. Manufacturer: Kj Meditech Co., Ltd.. Cleared Jun 2018. https://www.510kdatabase.net/k173162/ 2018-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k173162-gynecare-tvt-abdominal-guides-and-fda-510k.jpg K173162 - GYNECARE TVT Abdominal Guides and Couplers, GYNECARE TVT Reuseable Introducer, GYNECARE TVT Reusable Rigid Catheter Guide K173162 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ethicon, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k180562/ 2018-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k180562-temp-basic-temp-premium-temp-premium-fda-510k.jpg K180562 - TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT K180562 is a FDA 510(k) cleared dental medical device. Manufacturer: Zirkonzahn GmbH. Cleared Jun 2018. https://www.510kdatabase.net/k180583/ 2018-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k180583-logic-4k-camera-controller-logic-4k-fda-510k.jpg K180583 - LOGIC 4K CAMERA CONTROLLER, LOGIC 4K CAMERA HEAD K180583 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Richard Wolf Medical Instruments Corporation. Cleared Jun 2018. https://www.510kdatabase.net/k180729/ 2018-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k180729-faset-fixation-system-fda-510k.jpg K180729 - FaSet Fixation System K180729 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Huvexel Co. , Ltd.. Cleared Jun 2018. https://www.510kdatabase.net/k180829/ 2018-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k180829-prolene-polypropylene-mesh-non-fda-510k.jpg K180829 - PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh K180829 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k180865/ 2018-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k180865-zmi-self-adhesive-electrodes-fda-510k.jpg K180865 - ZMI Self-Adhesive Electrodes K180865 is a FDA 510(k) cleared neurology medical device. Manufacturer: Zmi Electronics , Ltd.. Cleared Jun 2018. https://www.510kdatabase.net/k180921/ 2018-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k180921-sapphire-ii-pro-balloon-dilatation-fda-510k.jpg K180921 - Sapphire II PRO Balloon Dilatation Catheter K180921 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Orbusneich Medical Trading, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k180993/ 2018-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k180993-beacon-advanced-co2-laser-system-fda-510k.jpg K180993 - Beacon Advanced CO2 Laser System K180993 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Omniguide, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k181121/ 2018-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k181121-beurer-ipl-5500-device-ipl-5000-ipl-fda-510k.jpg K181121 - Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro K181121 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Home Well Trading, Ltd.. Cleared Jun 2018. https://www.510kdatabase.net/k181144/ 2018-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k181144-angled-tip-ureteral-catheter-fda-510k.jpg K181144 - Angled Tip Ureteral Catheter K181144 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Jun 2018. https://www.510kdatabase.net/k181203/ 2018-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k181203-juliet-ti-fda-510k.jpg K181203 - Juliet Ti K181203 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spineart. Cleared Jun 2018. https://www.510kdatabase.net/k181404/ 2018-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k181404-varian-high-energy-linear-accelerator-fda-510k.jpg K181404 - Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator K181404 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k181474/ 2018-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k181474-articlip-laa-exclusion-system-fda-510k.jpg K181474 - ArtiClip LAA Exclusion System K181474 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: AtriCure, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k180364/ 2018-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k180364-hd-lifesciences-cervical-ibfd-system-fda-510k.jpg K180364 - HD LifeSciences Cervical IBFD System K180364 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Hd Lifesciences, LLC. Cleared Jun 2018. https://www.510kdatabase.net/k180454/ 2018-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k180454-shockwave-medical-intravascular-fda-510k.jpg K180454 - Shockwave Medical Intravascular Lithotripsy (IVL) System K180454 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shockwave Medical, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k180646/ 2018-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k180646-halyard-lavender-nitrile-powder-free-fda-510k.jpg K180646 - Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs K180646 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Halyard Health. Cleared Jun 2018. https://www.510kdatabase.net/k180720/ 2018-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k180720-medifine-pen-needle-3-bevel-fda-510k.jpg K180720 - Medifine Pen Needle 3 Bevel K180720 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medibio USA, LLC. Cleared Jun 2018. https://www.510kdatabase.net/k180858/ 2018-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k180858-callisto-eye-fda-510k.jpg K180858 - CALLISTO eye K180858 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Carl Zeiss Meditec, AG. Cleared Jun 2018. https://www.510kdatabase.net/k180895/ 2018-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k180895-alleye-fda-510k.jpg K180895 - Alleye K180895 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Oculocare Medical AG. Cleared Jun 2018. https://www.510kdatabase.net/k181141/ 2018-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k181141-overstitch-endoscopic-suturing-system-fda-510k.jpg K181141 - OverStitch Endoscopic Suturing System and Accessories K181141 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Apollo Endosurgery. Cleared Jun 2018. https://www.510kdatabase.net/k181413/ 2018-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k181413-udr-592h-udr-596i-fda-510k.jpg K181413 - uDR 592h, uDR 596i K181413 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Jun 2018. https://www.510kdatabase.net/k172846/ 2018-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k172846-uterine-manipulator-fda-510k.jpg K172846 - Uterine Manipulator K172846 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Beijing Hangtian Kadi Technology R&D Institute. Cleared Jun 2018. https://www.510kdatabase.net/k173361/ 2018-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k173361-iv-administration-set-fda-510k.jpg K173361 - IV Administration Set K173361 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k173574/ 2018-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k173574-denseemammo-fda-510k.jpg K173574 - DenSeeMammo K173574 is a FDA 510(k) cleared radiology medical device. Manufacturer: Statlife. Cleared Jun 2018. https://www.510kdatabase.net/k173725/ 2018-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k173725-neumodx-gbs-assay-fda-510k.jpg K173725 - NeuMoDx GBS Assay K173725 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Neumodx Molecular, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k173856/ 2018-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k173856-express-4-sleep-appliancecpap-sidekick-fda-510k.jpg K173856 - Express 4 Sleep appliance/CPAP Sidekick appliance K173856 is a FDA 510(k) cleared dental medical device. Manufacturer: Moses Appliances, LLC. Cleared Jun 2018. https://www.510kdatabase.net/k180769/ 2018-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k180769-securacath-fda-510k.jpg K180769 - SecurAcath K180769 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Interrad Medical, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k181119/ 2018-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k181119-range-denali-and-mesa-spinal-systems-fda-510k.jpg K181119 - Range (Denali and Mesa) Spinal Systems K181119 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: K2m, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k181438/ 2018-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k181438-diazyme-human-kappa-free-light-chain-fda-510k.jpg K181438 - Diazyme Human Kappa Free Light Chain Assay K181438 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diazyme Laboratories, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k172788/ 2018-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k172788-monet-anterior-cervical-interbody-fda-510k.jpg K172788 - MONET™ Anterior Cervical Interbody Fusion Cage System K172788 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ctl Medical Corporation. Cleared Jun 2018. https://www.510kdatabase.net/k180674/ 2018-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k180674-evol-ha-c-cervical-interbody-fusion-fda-510k.jpg K180674 - EVOL® ha-C Cervical Interbody Fusion System K180674 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Cutting Edge Spine, LLC. Cleared Jun 2018. https://www.510kdatabase.net/k180690/ 2018-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k180690-navigation-instruments-fda-510k.jpg K180690 - Navigation Instruments K180690 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k180701/ 2018-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k180701-safepath-suturing-system-fda-510k.jpg K180701 - SafePath Suturing System K180701 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Safepath Medical, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k180724/ 2018-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k180724-spira-open-matrix-llif-fda-510k.jpg K180724 - SPIRA Open Matrix LLIF K180724 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Camber Spine Technologies, LLC. Cleared Jun 2018. https://www.510kdatabase.net/k180975/ 2018-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k180975-quanta-flash-hmgcr-reagents-fda-510k.jpg K180975 - QUANTA Flash HMGCR Reagents K180975 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k180995/ 2018-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k180995-vscan-extend-fda-510k.jpg K180995 - Vscan Extend K180995 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared Jun 2018. https://www.510kdatabase.net/k181230/ 2018-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k181230-largan-55-methafilcon-a-daily-wear-fda-510k.jpg K181230 - Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lensfor ASTIGMATISM, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens for PRESBYOPIA K181230 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Largan Medical Co., Ltd.. Cleared Jun 2018. https://www.510kdatabase.net/k181329/ 2018-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k181329-elia-b2-glycoprotein-i-iga-immunoassay-fda-510k.jpg K181329 - EliA B2-Glycoprotein I IgA Immunoassay, EliA Cardiolipin IgA Immunoassay K181329 is a FDA 510(k) cleared immunology medical device. Manufacturer: Phadia AB. Cleared Jun 2018. https://www.510kdatabase.net/k181465/ 2018-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k181465-spaceoar-system-fda-510k.jpg K181465 - SpaceOAR System K181465 is a FDA 510(k) cleared radiology medical device. Manufacturer: Augmenix, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k151721/ 2018-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k151721-fiji-sun-fluorescent-tanning-unit-fda-510k.jpg K151721 - FIJI SUN FLUORESCENT TANNING UNIT K151721 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Kdb Inc. (Dba) Sperti Sunlamp. Cleared Jun 2018. https://www.510kdatabase.net/k170826/ 2018-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k170826-perfadex-plus-fda-510k.jpg K170826 - Perfadex Plus K170826 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Xvivo Perfusion AB. Cleared Jun 2018. https://www.510kdatabase.net/k172586/ 2018-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k172586-vios-monitoring-system-model-2050-fda-510k.jpg K172586 - Vios Monitoring System™ Model 2050 K172586 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vios Medical, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k172770/ 2018-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k172770-airos-6-sequential-compression-device-fda-510k.jpg K172770 - AIROS 6 Sequential Compression Device K172770 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Airos Medical, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k172779/ 2018-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k172779-airos-8-sequential-compression-device-fda-510k.jpg K172779 - AIROS 8 Sequential Compression Device K172779 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Airos Medical, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k173066/ 2018-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k173066-osseoduo-shaver-and-drill-system-fda-510k.jpg K173066 - OSSEODUO Shaver and Drill System K173066 is a FDA 510(k) cleared neurology medical device. Manufacturer: Bien-Air Surgery SA. Cleared Jun 2018. https://www.510kdatabase.net/k173414/ 2018-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k173414-advance-biliary-balloon-catheter-fda-510k.jpg K173414 - Advance Biliary Balloon Catheter K173414 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Jun 2018. https://www.510kdatabase.net/k173595/ 2018-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k173595-shear-wave-quantificational-ultrasound-fda-510k.jpg K173595 - Shear Wave Quantificational Ultrasound Diagnostic System K173595 is a FDA 510(k) cleared radiology medical device. Manufacturer: Wuxi Hisky Medical Technologies Co., Ltd.. Cleared Jun 2018. https://www.510kdatabase.net/k180152/ 2018-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k180152-gel-e-flex-fda-510k.jpg K180152 - gel-e Flex K180152 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Gel-E, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k180166/ 2018-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k180166-life-spine-lumbar-fixation-system-sentry-fda-510k.jpg K180166 - Life Spine Lumbar Fixation System (SENTRY) K180166 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k180282/ 2018-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k180282-mis-internal-hex-dental-implant-system-fda-510k.jpg K180282 - MIS Internal Hex Dental Implant System K180282 is a FDA 510(k) cleared dental medical device. Manufacturer: Mis Implants Technologies , Ltd.. Cleared Jun 2018. https://www.510kdatabase.net/k180331/ 2018-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k180331-wireless-pain-relieve-device-fda-510k.jpg K180331 - Wireless Pain Relieve Device K180331 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Dongdixin Technology Co., Ltd.. Cleared Jun 2018. https://www.510kdatabase.net/k180493/ 2018-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k180493-a3-total-knee-system-fda-510k.jpg K180493 - A3 Total Knee System K180493 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Beijing AK Medical Co., Ltd.. Cleared Jun 2018. https://www.510kdatabase.net/k180577/ 2018-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k180577-bioplex-2200-25-oh-vitamin-d-kit-fda-510k.jpg K180577 - BioPlex 2200 25-OH Vitamin D Kit K180577 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad Laboratories. Cleared Jun 2018. https://www.510kdatabase.net/k180581/ 2018-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k180581-uv-lamps-for-sunlamp-products-fda-510k.jpg K180581 - UV Lamps for Sunlamp Products K180581 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Feilo Sylvania Germany GmbH. Cleared Jun 2018. https://www.510kdatabase.net/k180594/ 2018-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k180594-knotless-suturetak-anchors-fda-510k.jpg K180594 - Knotless SutureTak Anchors K180594 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k180785/ 2018-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k180785-isleeve-introducer-set-fda-510k.jpg K180785 - iSLEEVE Introducer Set K180785 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Jun 2018. https://www.510kdatabase.net/k180815/ 2018-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k180815-mim-spectra-quant-fda-510k.jpg K180815 - MIM - SPECTRA Quant K180815 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mim Software, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k180824/ 2018-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k180824-vapro-2-intermittent-catheter-fda-510k.jpg K180824 - VaPro 2 Intermittent Catheter K180824 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hollister Incorporated. Cleared Jun 2018. https://www.510kdatabase.net/k180950/ 2018-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k180950-terumo-capiox-nx19-oxygenator-with-fda-510k.jpg K180950 - Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19 Oxygenator with Reservoir (west Orientation), Terumo Capiox NX19 Oxygenator (east Orientation), Terumo Capiox NX19 Oxygenator (west Orientation) K180950 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Cardiovascular Systems Corporation. Cleared Jun 2018. https://www.510kdatabase.net/k181051/ 2018-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k181051-impede-embolization-plug-5mm-impede-fda-510k.jpg K181051 - IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug, 10mm K181051 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shape Memory Medical. Cleared Jun 2018. https://www.510kdatabase.net/k181436/ 2018-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k181436-osom-mono-test-fda-510k.jpg K181436 - OSOM Mono Test K181436 is a FDA 510(k) cleared microbiology medical device. Manufacturer: SEKISUI Diagnostics, LLC. Cleared Jun 2018. https://www.510kdatabase.net/k181492/ 2018-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k181492-elecsys-ca-15-3-ii-fda-510k.jpg K181492 - Elecsys CA 15-3 II K181492 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics. Cleared Jun 2018. https://www.510kdatabase.net/den160006/ 2018-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/den160006-everlinq-endoavf-system-fda-510k.jpg DEN160006 - everlinQ endoAVF System DEN160006 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Tva Medical, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/den170004/ 2018-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/den170004-ellipsys-vascular-access-system-fda-510k.jpg DEN170004 - Ellipsys Vascular Access System DEN170004 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Avenu Medical, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k170886/ 2018-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k170886-homed-mesh-nebulizer-fda-510k.jpg K170886 - HOMED Mesh Nebulizer K170886 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Homed Medical Device Co., Ltd.. Cleared Jun 2018. https://www.510kdatabase.net/k172483/ 2018-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k172483-kopac-sterile-needle-fda-510k.jpg K172483 - Kopac Sterile Needle K172483 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Poonglim Pharmatech, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k172975/ 2018-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k172975-depuy-synthes-usa-50mm-73mm-crimp-fda-510k.jpg K172975 - DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins – MR Conditional, DePuy Synthes Variable Angle Positioning Pins – MR Conditional, DePuy Synthes Wire Mount – MR Conditional, DePuy Synthes Cerclage Positioning Pin – MR Conditional K172975 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k173028/ 2018-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k173028-bpro-bt-ambulatory-blood-pressure-fda-510k.jpg K173028 - BPro BT Ambulatory Blood Pressure Monitoring System with BProSoft BT PC Software K173028 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Healthstats International Pte. , Ltd.. Cleared Jun 2018. https://www.510kdatabase.net/k173348/ 2018-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k173348-09-sodium-chloride-injection-usp-fda-510k.jpg K173348 - 0.9% Sodium Chloride Injection, USP K173348 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k173717/ 2018-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k173717-integra-titan-reverse-shoulder-system-fda-510k.jpg K173717 - Integra TITAN Reverse Shoulder System K173717 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Integra LifeSciences Corporation. Cleared Jun 2018. https://www.510kdatabase.net/k180791/ 2018-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k180791-straumann-blx-surgical-cassette-fda-510k.jpg K180791 - Straumann BLX Surgical Cassette K180791 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Institut Straumann AG. Cleared Jun 2018. https://www.510kdatabase.net/k180809/ 2018-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k180809-eclipse-ii-fda-510k.jpg K180809 - Eclipse II K180809 is a FDA 510(k) cleared radiology medical device. Manufacturer: Carestream Health, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k181085/ 2018-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k181085-ligasure-maryland-jaw-thoracic-fda-510k.jpg K181085 - LigaSure Maryland Jaw Thoracic Sealer/Divider One-step Sealing, Nano-coated K181085 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien. Cleared Jun 2018. https://www.510kdatabase.net/k181437/ 2018-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k181437-pure-vu-system-fda-510k.jpg K181437 - Pure Vu System K181437 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Motus GI Medical Technologies , Ltd.. Cleared Jun 2018. https://www.510kdatabase.net/k172536/ 2018-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k172536-atlas-percussion-adjusting-instrument-fda-510k.jpg K172536 - Atlas Percussion Adjusting Instrument K172536 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Spinalight, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k173147/ 2018-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k173147-superno2va-et-device-fda-510k.jpg K173147 - SuperNO2VA Et Device K173147 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Revolutionary Medical Devices, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k180008/ 2018-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k180008-penumbra-system-fda-510k.jpg K180008 - Penumbra System K180008 is a FDA 510(k) cleared neurology medical device. Manufacturer: Penumbra, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k180377/ 2018-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k180377-fracture-and-correction-system-fda-510k.jpg K180377 - Fracture and Correction System K180377 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: In2bones USA, LLC. Cleared Jun 2018. https://www.510kdatabase.net/k180743/ 2018-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k180743-balanced-knee-revision-system-offset-fda-510k.jpg K180743 - Balanced Knee Revision System - Offset Junction Box K180743 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ortho Development Corporation. Cleared Jun 2018. https://www.510kdatabase.net/k180885/ 2018-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k180885-hairmax-laser-fda-510k.jpg K180885 - HairMax Laser K180885 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lexington International, LLC. Cleared Jun 2018. https://www.510kdatabase.net/k180911/ 2018-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k180911-visura-technologies-teecad-system-fda-510k.jpg K180911 - Visura Technologies TEECAD System K180911 is a FDA 510(k) cleared radiology medical device. Manufacturer: Visura Technologies, LLC. Cleared Jun 2018. https://www.510kdatabase.net/k181348/ 2018-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k181348-cartiva-sci-disposable-instrumentation-fda-510k.jpg K181348 - Cartiva SCI Disposable Instrumentation Set K181348 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Cartiva, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k181358/ 2018-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k181358-televere-digital-dental-imaging-system-fda-510k.jpg K181358 - Televere Digital Dental Imaging System K181358 is a FDA 510(k) cleared radiology medical device. Manufacturer: Televere Systems, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k181364/ 2018-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k181364-swiss-lithoclast-trilogy-fda-510k.jpg K181364 - Swiss LithoClast Trilogy K181364 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: E.M.S Electro Medical Systems S.A. Cleared Jun 2018. https://www.510kdatabase.net/k181368/ 2018-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k181368-vitek-2-ast-ys-micafungin-006-8-gml-fda-510k.jpg K181368 - VITEK 2 AST-YS Micafungin (<=0.06 - =>8 µg/mL) K181368 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k172346/ 2018-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k172346-stereos-workstation-fda-510k.jpg K172346 - sterEOS Workstation K172346 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eos Imaging. Cleared Jun 2018. https://www.510kdatabase.net/k173139/ 2018-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k173139-rightest-blood-glucose-monitoring-fda-510k.jpg K173139 - Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz Plus K173139 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bionime Corporation. Cleared Jun 2018. https://www.510kdatabase.net/k173316/ 2018-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k173316-speedbird-model-sb38-soft-tissue-fda-510k.jpg K173316 - SpeedBird Model SB38 Soft Tissue Biopsy Device K173316 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Transmed7, LLC. Cleared Jun 2018. https://www.510kdatabase.net/k173700/ 2018-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k173700-picoplus-laser-system-fda-510k.jpg K173700 - PICOPLUS Laser System K173700 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lutronic Corporation. Cleared Jun 2018. https://www.510kdatabase.net/k173905/ 2018-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k173905-surgic-pro-surgic-pro-fda-510k.jpg K173905 - Surgic Pro, Surgic Pro+ K173905 is a FDA 510(k) cleared dental medical device. Manufacturer: Nakanishi, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k180472/ 2018-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k180472-visi-mobile-monitoring-system-fda-510k.jpg K180472 - ViSi Mobile Monitoring System K180472 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sotera Wireless, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k180710/ 2018-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k180710-reprocessed-decanav-diagnostic-fda-510k.jpg K180710 - Reprocessed DecaNav Diagnostic Electrophysiology Catheter K180710 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Innovative Health, LLC. Cleared Jun 2018. https://www.510kdatabase.net/k180847/ 2018-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k180847-neutrogena-light-therapy-acne-mask-fda-510k.jpg K180847 - Neutrogena Light Therapy Acne Mask+ K180847 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Johnson & Johnson Consumer, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k180856/ 2018-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k180856-neutrogena-light-therapy-aging-mask-fda-510k.jpg K180856 - Neutrogena Light Therapy Aging Mask+ K180856 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Johnson & Johnson Consumer, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k181389/ 2018-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k181389-valleylab-ft10-energy-platform-fda-510k.jpg K181389 - Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform K181389 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien. Cleared Jun 2018. https://www.510kdatabase.net/k172345/ 2018-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k172345-iu-implant-system-fda-510k.jpg K172345 - IU Implant System K172345 is a FDA 510(k) cleared dental medical device. Manufacturer: Warantec Co., Ltd.. Cleared Jun 2018. https://www.510kdatabase.net/k172842/ 2018-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k172842-gce704-breast-pump-fda-510k.jpg K172842 - GCE704 Breast Pump K172842 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Globalcare. Cleared Jun 2018. https://www.510kdatabase.net/k172895/ 2018-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k172895-age-automatic-upper-arm-blood-pressure-fda-510k.jpg K172895 - AGE Automatic Upper Arm Blood Pressure Monitor with models BA-815, BA-816, BA-818 and BA-819 K172895 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ageless Health Industrial Co., Ltd.. Cleared Jun 2018. https://www.510kdatabase.net/k180560/ 2018-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k180560-sherlock-3cg-t-ip-confirmation-system-fda-510k.jpg K180560 - Sherlock 3CG+ T ip Confirmation System K180560 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k180726/ 2018-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k180726-savion-dlvr-guidewire-savion-flx-fda-510k.jpg K180726 - Savion DLVR Guidewire, Savion FLX Guidewire K180726 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k180761/ 2018-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k180761-sd-ltm-stim-cortical-stimulator-fda-510k.jpg K180761 - SD LTM STIM Cortical Stimulator K180761 is a FDA 510(k) cleared neurology medical device. Manufacturer: Micromed S.P.A.. Cleared Jun 2018. https://www.510kdatabase.net/k181484/ 2018-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k181484-tecno-med-tecno-med-mineral-tecno-med-fda-510k.jpg K181484 - Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue K181484 is a FDA 510(k) cleared dental medical device. Manufacturer: Zirkonzahn Srl. Cleared Jun 2018. https://www.510kdatabase.net/k181325/ 2018-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k181325-flowtriever-retrievalaspiration-system-fda-510k.jpg K181325 - FlowTriever Retrieval/Aspiration System K181325 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inari Medical, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k170835/ 2018-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k170835-electro-antiperspirant-electro-fda-510k.jpg K170835 - Electro Antiperspirant, Electro Antiperspirant Sensitive, Electro Antiperspirant ELITE K170835 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Hightech Development. Cleared Jun 2018. https://www.510kdatabase.net/k172551/ 2018-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k172551-trinity-plus-acetabular-shell-fda-510k.jpg K172551 - Trinity PLUS Acetabular Shell K172551 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corin U.S.A. Limited. Cleared Jun 2018. https://www.510kdatabase.net/k172954/ 2018-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k172954-medline-prevention-coolzone-gown-fda-510k.jpg K172954 - Medline Prevention CoolZone Gown K172954 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k173225/ 2018-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k173225-interlude-and-private-label-unscented-fda-510k.jpg K173225 - Interlude and private label Unscented 3-piece compact applicator tampon K173225 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Albaad Fem. Cleared Jun 2018. https://www.510kdatabase.net/k173507/ 2018-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k173507-prodiva-15t-cx-and-prodiva-15t-cs-r54-fda-510k.jpg K173507 - Prodiva 1.5T CX and Prodiva 1.5T CS R5.4 K173507 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Healthcare (Suzhou) Co., Ltd.. Cleared Jun 2018. https://www.510kdatabase.net/k173908/ 2018-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k173908-dess-dental-smart-solutions-fda-510k.jpg K173908 - DESS Dental Smart Solutions K173908 is a FDA 510(k) cleared dental medical device. Manufacturer: Terrats Medical SL. Cleared Jun 2018. https://www.510kdatabase.net/k173936/ 2018-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k173936-natus-photic-stimulator-fda-510k.jpg K173936 - Natus Photic Stimulator K173936 is a FDA 510(k) cleared neurology medical device. Manufacturer: Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). Cleared Jun 2018. https://www.510kdatabase.net/k180497/ 2018-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k180497-scone-mask-fda-510k.jpg K180497 - Scone Mask K180497 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Resmed, Ltd.. Cleared Jun 2018. https://www.510kdatabase.net/k180749/ 2018-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k180749-life-spine-simpact-sacroiliac-joint-fda-510k.jpg K180749 - Life Spine SIMPACT Sacroiliac Joint Fixation System K180749 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k181113/ 2018-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k181113-colink-afx-plating-system-fda-510k.jpg K181113 - CoLink™ Afx Plating System K181113 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: In2bones USA, LLC. Cleared Jun 2018. https://www.510kdatabase.net/k181290/ 2018-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k181290-fusion-bx-20-fda-510k.jpg K181290 - Fusion Bx 2.0 K181290 is a FDA 510(k) cleared radiology medical device. Manufacturer: Focal Healthcare, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k172011/ 2018-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k172011-lifesignals-wipoint-biosensorios-fda-510k.jpg K172011 - LifeSignals WiPoint Biosensor_iOS Receiver_App System (LifeSignals WiPatch & WiApp System) K172011 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hmicro, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k172787/ 2018-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k172787-access-hstnl-fda-510k.jpg K172787 - Access hsTnl K172787 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k172800/ 2018-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k172800-portex-lancet-point-spinal-needles-fda-510k.jpg K172800 - Portex® Lancet Point Spinal Needles with NRFit™ connectors, Portex® Pencil Point Spinal Needles with NRFit™ connectors K172800 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Smiths Medical Asd, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k172938/ 2018-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k172938-disposable-sterile-needle-fda-510k.jpg K172938 - Disposable Sterile Needle K172938 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Caina Medical Co.,Ltd. Cleared Jun 2018. https://www.510kdatabase.net/k172985/ 2018-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k172985-ligation-device-fda-510k.jpg K172985 - Ligation Device K172985 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Leo Medical Co., Ltd.. Cleared Jun 2018. https://www.510kdatabase.net/k173376/ 2018-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k173376-asi-evolution-fda-510k.jpg K173376 - ASI Evolution K173376 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Arlington Scientific, Inc. (Asi). Cleared Jun 2018. https://www.510kdatabase.net/k173455/ 2018-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k173455-surgtech-bipolar-head-system-fda-510k.jpg K173455 - SurgTech Bipolar Head System K173455 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Surgtech, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k173780/ 2018-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k173780-echomd-automated-ejection-fraction-fda-510k.jpg K173780 - EchoMD Automated Ejection Fraction Software K173780 is a FDA 510(k) cleared radiology medical device. Manufacturer: Bay Labs, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k173977/ 2018-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k173977-carto-3-ep-navigation-system-version-fda-510k.jpg K173977 - CARTO 3 EP Navigation System, Version 4.35 and Accessories with COHERENT MAP Module K173977 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biosense Webster, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k180100/ 2018-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k180100-mriaudio-prem-system-fda-510k.jpg K180100 - MRIaudio PREM System K180100 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mriaudio. Cleared Jun 2018. https://www.510kdatabase.net/k180290/ 2018-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k180290-natus-brain-monitor-amplifier-fda-510k.jpg K180290 - Natus Brain Monitor Amplifier K180290 is a FDA 510(k) cleared neurology medical device. Manufacturer: Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). Cleared Jun 2018. https://www.510kdatabase.net/k180401/ 2018-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k180401-tiwave-c-porous-titanium-cervical-cage-fda-510k.jpg K180401 - TiWAVE-C™ Porous Titanium Cervical Cage K180401 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Kalitec Direct, LLC. Cleared Jun 2018. https://www.510kdatabase.net/k180502/ 2018-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k180502-s128-anterior-lumbar-interbody-fusion-fda-510k.jpg K180502 - S128 Anterior Lumbar Interbody Fusion (ALIF) System K180502 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Renovis Surgical Technologies, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k180505/ 2018-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k180505-nitrile-powder-free-examination-glove-fda-510k.jpg K180505 - Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP with Low-Dermatitis Potential Claim and Tested For Use with Chemotherapy Drugs (White) K180505 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hartalega Sdn Bhd. Cleared Jun 2018. https://www.510kdatabase.net/k180719/ 2018-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k180719-inmode-diolaze-system-fda-510k.jpg K180719 - InMode Diolaze System K180719 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Inmode MD , Ltd.. Cleared Jun 2018. https://www.510kdatabase.net/k180738/ 2018-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k180738-compactcath-lubricated-intermittent-fda-510k.jpg K180738 - COMPACTCATH Lubricated Intermittent UrinaryCatheter and OneCath Intermittent Urinary Catheter K180738 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Compactcath, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k180813/ 2018-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k180813-btl-799-2-fda-510k.jpg K180813 - BTL 799-2 K180813 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: BTL Industries, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k181280/ 2018-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k181280-patello-femoral-wave-kahuna-fda-510k.jpg K181280 - Patello-Femoral Wave (Kahuna) Arthroplasty System K181280 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrosurface, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k181301/ 2018-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k181301-smart-external-drain-sed-system-fda-510k.jpg K181301 - Smart External Drain (SED) System K181301 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aqueduct Critical Care, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k181316/ 2018-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k181316-pogo-automatic-blood-glucose-fda-510k.jpg K181316 - POGO Automatic Blood Glucose Monitoring System K181316 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Intuity Medical, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k181351/ 2018-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k181351-double-flexible-tipped-wire-guides-fda-510k.jpg K181351 - Double Flexible Tipped Wire Guides K181351 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Jun 2018. https://www.510kdatabase.net/k172983/ 2018-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k172983-healthccs-fda-510k.jpg K172983 - HealthCCS K172983 is a FDA 510(k) cleared radiology medical device. Manufacturer: Zebra Medical Vision, Ltd.. Cleared Jun 2018. https://www.510kdatabase.net/k173259/ 2018-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k173259-case-medical-steritite-reusable-rigid-fda-510k.jpg K173259 - Case Medical SteriTite Reusable Rigid Sterilization Container System with MediTray accessories K173259 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Case Medical, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k180565/ 2018-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k180565-peak-ns033cf-peak-ns017cf-fda-510k.jpg K180565 - PEAK NS033CF, PEAK NS017CF K180565 is a FDA 510(k) cleared dental medical device. Manufacturer: Neosil Co., Ltd.. Cleared Jun 2018. https://www.510kdatabase.net/k180675/ 2018-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k180675-atlas-spine-expandable-cervical-fda-510k.jpg K180675 - Atlas Spine Expandable Cervical Interbody System K180675 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Atlas Spine, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k180681/ 2018-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k180681-aptima-combo-2-assay-panther-system-fda-510k.jpg K180681 - Aptima Combo 2 Assay (Panther System) K180681 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Hologic, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k180818/ 2018-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k180818-catamaran-sacroiliac-joint-fixation-fda-510k.jpg K180818 - Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) K180818 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tenon Medical, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k180861/ 2018-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k180861-vinyl-examination-glove-clear-non-fda-510k.jpg K180861 - Vinyl Examination Glove (Clear, Non-Colored) K180861 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zhicheng Trading Co., Ltd.. Cleared Jun 2018. https://www.510kdatabase.net/k180989/ 2018-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k180989-pedra-17f-digital-flat-panel-x-ray-fda-510k.jpg K180989 - PEDRA-17F Digital Flat Panel X-ray Detector K180989 is a FDA 510(k) cleared radiology medical device. Manufacturer: Radisen, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k181050/ 2018-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k181050-desio-hioxifilcon-d-daily-wear-soft-fda-510k.jpg K181050 - Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted) K181050 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Qualimed Srl. Cleared Jun 2018. https://www.510kdatabase.net/k181271/ 2018-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k181271-signature-orthodontic-system-fda-510k.jpg K181271 - Signature Orthodontic System K181271 is a FDA 510(k) cleared dental medical device. Manufacturer: Signature Orthodontics. Cleared Jun 2018. https://www.510kdatabase.net/k181279/ 2018-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k181279-ysio-max-fda-510k.jpg K181279 - Ysio Max K181279 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medi Cal Solutions, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k181298/ 2018-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k181298-harmony-xl-multi-application-platform-fda-510k.jpg K181298 - Harmony XL Multi-Application Platform K181298 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Alma Lasers, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k181363/ 2018-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k181363-ecovue-sterile-and-non-sterile-fda-510k.jpg K181363 - EcoVue Sterile and Non-Sterile Ultrasound Gels K181363 is a FDA 510(k) cleared radiology medical device. Manufacturer: H R Pharmaceuticals, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k181429/ 2018-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k181429-celerity-20-hp-biological-indicator-fda-510k.jpg K181429 - CELERITY 20 HP Biological Indicator K181429 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Jun 2018. https://www.510kdatabase.net/k181442/ 2018-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k181442-verify-assert-self-contained-fda-510k.jpg K181442 - VERIFY Assert Self-Contained Biological Indicator K181442 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Jun 2018. https://www.510kdatabase.net/k172783/ 2018-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k172783-access-hs-tnl-fda-510k.jpg K172783 - Access hs Tnl K172783 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k172823/ 2018-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k172823-portex-nrfit-epidural-needles-fda-510k.jpg K172823 - Portex NRFit Epidural Needles K172823 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Smiths Medical Asd, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k172831/ 2018-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k172831-perfusor-space-syringe-infusion-pump-fda-510k.jpg K172831 - Perfusor® Space Syringe Infusion Pump System K172831 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k172833/ 2018-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k172833-e-xpe-acetabular-components-and-u-fda-510k.jpg K172833 - E-XPE Acetabular Components and U-Motion II Acetabular Cup K172833 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: United Orthopedic Corporation. Cleared Jun 2018. https://www.510kdatabase.net/k180124/ 2018-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k180124-zquiet-fda-510k.jpg K180124 - ZQuiet K180124 is a FDA 510(k) cleared dental medical device. Manufacturer: Sleeping Well, LLC. Cleared Jun 2018. https://www.510kdatabase.net/k180260/ 2018-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k180260-powder-free-vinyl-patient-examination-fda-510k.jpg K180260 - Powder Free Vinyl Patient Examination Gloves (Yellow, White) K180260 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shanxi Hongjin Plastic Technology Co., Ltd.. Cleared Jun 2018. https://www.510kdatabase.net/k180452/ 2018-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k180452-white-nitrile-examination-glove-fda-510k.jpg K180452 - White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim K180452 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Riverstone Resources Sdn Bhd. Cleared Jun 2018. https://www.510kdatabase.net/k181093/ 2018-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k181093-symri-fda-510k.jpg K181093 - SyMRI K181093 is a FDA 510(k) cleared radiology medical device. Manufacturer: Syntheticmr AB. Cleared Jun 2018. https://www.510kdatabase.net/k181343/ 2018-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k181343-heartsee-cardiac-pet-processing-software-fda-510k.jpg K181343 - HeartSee Cardiac P.E.T. Processing Software K181343 is a FDA 510(k) cleared radiology medical device. Manufacturer: Bracco Diagnostics, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/den170043/ 2018-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/den170043-dreamed-advisor-pro-fda-510k.jpg DEN170043 - DreaMed Advisor Pro DEN170043 is a FDA 510(k) cleared chemistry medical device. Manufacturer: DreaMed Diabetes, Ltd.. Cleared Jun 2018. https://www.510kdatabase.net/k171422/ 2018-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k171422-disposable-powder-free-nitrile-fda-510k.jpg K171422 - Disposable Powder Free Nitrile Examination Glove, White/ Blue/ Black/ Pink Color K171422 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ever Global (Vietnam) Enterprise Corp. Cleared Jun 2018. https://www.510kdatabase.net/k172821/ 2018-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k172821-ti-one-101-ts-dental-implant-system-fda-510k.jpg K172821 - Ti-one 101 TS Dental Implant System K172821 is a FDA 510(k) cleared dental medical device. Manufacturer: Hung Chun Bio-S Co., Ltd.. Cleared Jun 2018. https://www.510kdatabase.net/k172835/ 2018-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k172835-gri-alleset-veress-needle-fda-510k.jpg K172835 - GRI-Alleset Veress Needle K172835 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Gri Medical and Electronic Technology Co., Ltd.. Cleared Jun 2018. https://www.510kdatabase.net/k172961/ 2018-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k172961-liac-hwl-fda-510k.jpg K172961 - LIAC HWL K172961 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sit Sordina Iort Technologies Spa. Cleared Jun 2018. https://www.510kdatabase.net/k173200/ 2018-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k173200-sofia-plus-aspiration-catheter-fda-510k.jpg K173200 - SOFIA Plus Aspiration Catheter K173200 is a FDA 510(k) cleared neurology medical device. Manufacturer: MicroVention, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k173503/ 2018-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k173503-pollogen-legend-system-fda-510k.jpg K173503 - Pollogen Legend System K173503 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Pollogen, Ltd.. Cleared Jun 2018. https://www.510kdatabase.net/k173787/ 2018-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k173787-x-mesh-expandable-cage-system-ocelot-fda-510k.jpg K173787 - X-MESH® Expandable Cage System, OCELOT® Stackable Cage System, Stackable Cage System, Surgical Titanium Mesh System, BENGAL Stackable Cage System, BENGAL System, CONCORDE® System, CONCORDE® Inline Lumbar Interbody System, CONCORDE® Curve Lumbar Interbody System, CONCORDE® Bullet Lumbar Interbody System, COUGAR® System, COUGAR® LS Lateral Cage System, DEVEX® System, LEOPARD® System, DePuy PULSE Cervical Cage System, DePuy PULSE Lumbar Cage System, LUMBAR I/F CAGE® System K173787 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medos International SARL. Cleared Jun 2018. https://www.510kdatabase.net/k173803/ 2018-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k173803-omnican-fine-fda-510k.jpg K173803 - Omnican fine K173803 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k180649/ 2018-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k180649-beauticem-veneer-kit-fda-510k.jpg K180649 - BeautiCem Veneer Kit K180649 is a FDA 510(k) cleared dental medical device. Manufacturer: Shofu Dental Corporation. Cleared Jun 2018. https://www.510kdatabase.net/k180722/ 2018-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k180722-capere-thrombectomy-system-fda-510k.jpg K180722 - CAPERE Thrombectomy System K180722 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Kp Medcure, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k180766/ 2018-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k180766-endiscope-endiscope-cervical-fda-510k.jpg K180766 - Endiscope, Endiscope Cervical K180766 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Elliquence, LLC. Cleared Jun 2018. https://www.510kdatabase.net/k180849/ 2018-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k180849-vinyl-examination-glove-clear-non-fda-510k.jpg K180849 - Vinyl Examination Glove (Clear, Non-Colored) K180849 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Huifu Trading Co., Ltd.. Cleared Jun 2018. https://www.510kdatabase.net/k180959/ 2018-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k180959-phenom-27-catheter-fda-510k.jpg K180959 - Phenom 27 Catheter K180959 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cathera, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k181281/ 2018-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k181281-altus-spine-pedicle-screw-system-fda-510k.jpg K181281 - Altus Spine Pedicle Screw System K181281 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Altus Partners, LLC. Cleared Jun 2018. https://www.510kdatabase.net/k172725/ 2018-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k172725-vt-dressing-kits-fda-510k.jpg K172725 - VT Dressing Kits K172725 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Carilex Medical, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k172981/ 2018-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k172981-reusable-spo2-sensors-disposable-spo2-fda-510k.jpg K172981 - Reusable SpO2 Sensors, Disposable SpO2 Sensors K172981 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: APK Technology Co., Ltd.. Cleared Jun 2018. https://www.510kdatabase.net/k173070/ 2018-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k173070-hsw-resection-instruments-fda-510k.jpg K173070 - HSW Resection Instruments K173070 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Henke-Sass, Wolf GmbH. Cleared Jun 2018. https://www.510kdatabase.net/k173156/ 2018-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k173156-integrated-cardiorespiratory-system-fda-510k.jpg K173156 - Integrated CardioRespiratory System K173156 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sensydia, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k173189/ 2018-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k173189-lumfuse-tp-fda-510k.jpg K173189 - Lumfuse TP K173189 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Precifit Medical, Ltd.. Cleared Jun 2018. https://www.510kdatabase.net/k173706/ 2018-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k173706-piccolo-implants-and-accessories-fda-510k.jpg K173706 - Piccolo Implants and Accessories K173706 is a FDA 510(k) cleared dental medical device. Manufacturer: Southern Implants (Pty), Ltd.. Cleared Jun 2018. https://www.510kdatabase.net/k180306/ 2018-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k180306-nexy-fda-510k.jpg K180306 - Nexy K180306 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Next Sight Srl. Cleared Jun 2018. https://www.510kdatabase.net/k180332/ 2018-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k180332-17hk700g-w-fda-510k.jpg K180332 - 17HK700G-W K180332 is a FDA 510(k) cleared radiology medical device. Manufacturer: Lg Electronics. Cleared Jun 2018. https://www.510kdatabase.net/k180449/ 2018-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k180449-single-use-aspiration-needle-na-u200h-fda-510k.jpg K180449 - Single Use Aspiration Needle NA-U200H K180449 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Jun 2018. https://www.510kdatabase.net/k180660/ 2018-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k180660-avanti-fda-510k.jpg K180660 - Avanti K180660 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Optovue, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k180904/ 2018-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k180904-sniper-infusion-catheter-with-balloon-fda-510k.jpg K180904 - Sniper Infusion Catheter with Balloon Occlusion K180904 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Embolx, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k180985/ 2018-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k180985-aveo-omafilcon-a-soft-hydrophilic-fda-510k.jpg K180985 - Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses K180985 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Supervision Optimax Sdn Bhd. Cleared Jun 2018. https://www.510kdatabase.net/k180988/ 2018-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k180988-acuity-18-enflufocon-a-rigid-gas-fda-510k.jpg K180988 - Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufocon B) Rigid Gas Permeable Contact Lens, Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens, Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens K180988 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Acuity Polymers, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k172121/ 2018-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k172121-digital-thermometer-fda-510k.jpg K172121 - Digital Thermometer K172121 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Fudakang Industrial Co., Ltd.. Cleared Jun 2018. https://www.510kdatabase.net/k172721/ 2018-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k172721-focal-one-fda-510k.jpg K172721 - FOCAL ONE K172721 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Edap Technomed, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k172909/ 2018-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k172909-elevare-perfectio-4-fda-510k.jpg K172909 - ELEVARE, PERFECTIO 4 K172909 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Omm Imports D/B/A Zero Gravity. Cleared Jun 2018. https://www.510kdatabase.net/k173032/ 2018-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k173032-paxman-scalp-cooler-fda-510k.jpg K173032 - Paxman Scalp Cooler K173032 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Paxman Coolers Limited. Cleared Jun 2018. https://www.510kdatabase.net/k173155/ 2018-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k173155-pakter-curved-needle-set-fda-510k.jpg K173155 - Pakter Curved Needle Set K173155 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Cook Incorporated. Cleared Jun 2018. https://www.510kdatabase.net/k173573/ 2018-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k173573-tetric-cad-fda-510k.jpg K173573 - Tetric CAD K173573 is a FDA 510(k) cleared dental medical device. Manufacturer: Ivoclar Vivadent, AG. Cleared Jun 2018. https://www.510kdatabase.net/k173577/ 2018-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k173577-guarded-luer-connector-fda-510k.jpg K173577 - Guarded Luer Connector K173577 is a FDA 510(k) cleared general hospital medical device. Manufacturer: International Medical Industries, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k180122/ 2018-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k180122-tyrx-neuro-absorbable-antibacterial-fda-510k.jpg K180122 - TYRX Neuro Absorbable Antibacterial Envelope (medium) K180122 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medtronic, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k180188/ 2018-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k180188-geri-embryo-incubator-with-geri-fda-510k.jpg K180188 - Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish K180188 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Genea Biomedx Pty, Ltd.. Cleared Jun 2018. https://www.510kdatabase.net/k180459/ 2018-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k180459-verasense-for-zimmer-biomet-persona-fda-510k.jpg K180459 - VERASENSE for Zimmer Biomet Persona K180459 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthosensor, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k180612/ 2018-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k180612-triathlon-pkr-x3-tibial-inserts-mako-fda-510k.jpg K180612 - Triathlon PKR X3 Tibial Inserts, Mako X3 Uni Onlay Tibial Inserts K180612 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics. Cleared Jun 2018. https://www.510kdatabase.net/k180839/ 2018-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k180839-at-030-fda-510k.jpg K180839 - AT 030 K180839 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Carl Zeiss Meditec, AG. Cleared Jun 2018. https://www.510kdatabase.net/k180947/ 2018-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k180947-orthopantomograph-op-3d-fda-510k.jpg K180947 - Orthopantomograph OP 3D K180947 is a FDA 510(k) cleared radiology medical device. Manufacturer: Palodex Group OY. Cleared Jun 2018. https://www.510kdatabase.net/k180956/ 2018-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k180956-electrical-stimulator-model-r-c1-tens-fda-510k.jpg K180956 - Electrical Stimulator - Model R-C1 TENS and EMS stimulator, Model R-E1 EMS stimulator, Model R-T1 TENS Stimulator K180956 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Roundwhale Technology Co. , Ltd.. Cleared Jun 2018. https://www.510kdatabase.net/k181264/ 2018-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k181264-qlab-advanced-quantification-software-fda-510k.jpg K181264 - QLAB Advanced Quantification Software K181264 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Ultrasound, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k172221/ 2018-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k172221-vtrust-vital-signs-monitor-model-td-2300-fda-510k.jpg K172221 - VTRUST Vital Signs Monitor, Model: TD-2300 K172221 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Taidoc Technology Corporation. Cleared Jun 2018. https://www.510kdatabase.net/k172780/ 2018-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k172780-sd1-ultrasonic-pocket-doppler-fda-510k.jpg K172780 - SD1 Ultrasonic Pocket Doppler K172780 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Edan Instruments, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k173053/ 2018-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k173053-powder-free-latex-examination-glove-fda-510k.jpg K173053 - POWDER FREE LATEX EXAMINATION GLOVE K173053 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Professional Latex Sdn Bhd. Cleared Jun 2018. https://www.510kdatabase.net/k180427/ 2018-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k180427-ark-fentanyl-assay-fda-510k.jpg K180427 - ARK Fentanyl Assay K180427 is a FDA 510(k) cleared toxicology medical device. Manufacturer: ARK Diagnostics, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k180436/ 2018-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k180436-t2-alpha-tibia-nailing-system-t2-alpha-fda-510k.jpg K180436 - T2 Alpha Tibia Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System K180436 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Trauma GmbH. Cleared Jun 2018. https://www.510kdatabase.net/k180621/ 2018-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k180621-echomark-echomark-lp-fda-510k.jpg K180621 - EchoMark, EchoMark LP K180621 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sonavex, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k180672/ 2018-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k180672-sterilization-pouchroll-made-with-tyvek-fda-510k.jpg K180672 - Sterilization Pouch/Roll Made with Tyvek K180672 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sigma Medical Supplies Corporation. Cleared Jun 2018. https://www.510kdatabase.net/k180709/ 2018-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k180709-trusculpt-rf-device-fda-510k.jpg K180709 - truSculpt RF Device K180709 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cutera, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k180712/ 2018-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k180712-coconut-infused-hybrid-personal-fda-510k.jpg K180712 - Coconut Infused Hybrid Personal Lubricant K180712 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: United Consortium. Cleared Jun 2018. https://www.510kdatabase.net/k180832/ 2018-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k180832-salvation-external-fixation-system-fda-510k.jpg K180832 - SALVATION External Fixation System K180832 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jun 2018. https://www.510kdatabase.net/k180925/ 2018-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k180925-umr-570-fda-510k.jpg K180925 - uMR 570 K180925 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Jun 2018. https://www.510kdatabase.net/k180926/ 2018-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k180926-umr-560-fda-510k.jpg K180926 - uMR 560 K180926 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Jun 2018. https://www.510kdatabase.net/k181202/ 2018-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k181202-sentry-ivc-filter-fda-510k.jpg K181202 - Sentry IVC Filter K181202 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Novate Medical , Ltd.. Cleared Jun 2018. https://www.510kdatabase.net/k181207/ 2018-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k181207-balego-tens-digital-edition-with-fda-510k.jpg K181207 - Balego TENS Digital Edition with Accessories for Pain Relief (OTC) K181207 is a FDA 510(k) cleared neurology medical device. Manufacturer: Everyway Medical Instruments Co., Ldt.. Cleared Jun 2018. https://www.510kdatabase.net/k172745/ 2018-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k172745-immuglo-hep-2-elite-ifa-fda-510k.jpg K172745 - ImmuGlo HEp-2 Elite IFA K172745 is a FDA 510(k) cleared immunology medical device. Manufacturer: Immco Diagnostics, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k173045/ 2018-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k173045-oximeter-fda-510k.jpg K173045 - Oximeter K173045 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Greatmade Tech Limited. Cleared Jun 2018. https://www.510kdatabase.net/k173093/ 2018-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k173093-tama-bems-device-fda-510k.jpg K173093 - TAMA BEMS device K173093 is a FDA 510(k) cleared neurology medical device. Manufacturer: Tama Research Corporation. Cleared Jun 2018. https://www.510kdatabase.net/k173821/ 2018-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k173821-lungq-software-fda-510k.jpg K173821 - LungQ Software K173821 is a FDA 510(k) cleared radiology medical device. Manufacturer: Thirona Corporation. Cleared Jun 2018. https://www.510kdatabase.net/k173961/ 2018-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k173961-straumann-blx-implant-system-fda-510k.jpg K173961 - Straumann BLX Implant System K173961 is a FDA 510(k) cleared dental medical device. Manufacturer: Institut Straumann AG. Cleared Jun 2018. https://www.510kdatabase.net/k180191/ 2018-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k180191-superball-meniscal-repair-system-fda-510k.jpg K180191 - SuperBall Meniscal Repair System K180191 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Arcuro Medical , Ltd.. Cleared Jun 2018. https://www.510kdatabase.net/k180593/ 2018-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k180593-vbeam-prima-laser-system-fda-510k.jpg K180593 - Vbeam Prima Laser System K180593 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Syneron-Candela. Cleared Jun 2018. https://www.510kdatabase.net/k180608/ 2018-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k180608-lunoa-system-fda-510k.jpg K180608 - Lunoa System K180608 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Nightbalance BV. Cleared Jun 2018. https://www.510kdatabase.net/k180661/ 2018-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k180661-sigma-sterilization-pouch-and-roll-fda-510k.jpg K180661 - SIGMA Sterilization Pouch and Roll K180661 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sigma Medical Supplies Corp.. Cleared Jun 2018. https://www.510kdatabase.net/den170089/ 2018-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/den170089-curve-positive-airway-pressure-system-fda-510k.jpg DEN170089 - Curve Positive Airway Pressure System DEN170089 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Fresca Medical. Cleared Jun 2018. https://www.510kdatabase.net/k171609/ 2018-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k171609-check-flo-performer-introducer-fda-510k.jpg K171609 - Check-Flo Performer Introducer Micropuncture Radial Artery Access Set K171609 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Jun 2018. https://www.510kdatabase.net/k172763/ 2018-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k172763-blood-collecting-needle-safety-blood-fda-510k.jpg K172763 - Blood Collecting Needle, Safety Blood Collecting Needle, Blood Collecting Needle with Holder, Safety Blood Collecting Needle with Holder, Blood Collecting Set, Safety Blood Collecting Set, Blood Collecting Set with Holder, Safety Blood Collecting Set with Holder K172763 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zhejiang Kindly Medical Devices Co., Ltd.. Cleared Jun 2018. https://www.510kdatabase.net/k172807/ 2018-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k172807-silicone-foley-catheter-for-single-use-fda-510k.jpg K172807 - Silicone Foley Catheter for single use K172807 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Changzhou Rongxin Medicine Minimal Invasion Technology. Cleared Jun 2018. https://www.510kdatabase.net/k180447/ 2018-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k180447-revive-light-therapy-led-cleansing-fda-510k.jpg K180447 - reVive Light Therapy LED Cleansing System K180447 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Led Technologies, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k180500/ 2018-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k180500-variax-2-system-fda-510k.jpg K180500 - VariAx 2 System K180500 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker GmbH. Cleared Jun 2018. https://www.510kdatabase.net/k180640/ 2018-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k180640-smartclip-soft-tissue-marker-fda-510k.jpg K180640 - SmartClip Soft Tissue Marker K180640 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Elucent Medical, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k181012/ 2018-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k181012-buhlmann-fcal-elisa-fda-510k.jpg K181012 - BUHLMANN fCAL ELISA K181012 is a FDA 510(k) cleared immunology medical device. Manufacturer: Buhlmann Laboratories AG. Cleared Jun 2018. https://www.510kdatabase.net/k171798/ 2018-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k171798-silverwear-silver-pro-garment-device-fda-510k.jpg K171798 - Silverwear Silver Pro Garment Device K171798 is a FDA 510(k) cleared neurology medical device. Manufacturer: Media Plus, LLC. Cleared Jun 2018. https://www.510kdatabase.net/k172068/ 2018-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k172068-kenz-cardico1211-fda-510k.jpg K172068 - Kenz Cardico1211 K172068 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Suzuken Co., Ltd.. Cleared Jun 2018. https://www.510kdatabase.net/k172234/ 2018-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k172234-oxygen-concentrator-fda-510k.jpg K172234 - Oxygen Concentrator K172234 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sysmed (China) Co., Ltd.. Cleared Jun 2018. https://www.510kdatabase.net/k172410/ 2018-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k172410-portex-nrfit-epidural-needles-portex-fda-510k.jpg K172410 - Portex NRFit Epidural Needles, Portex NRFit Spinal Needles, Portex NRFit Loss of Resistance (L.O.R.) Syringes., Portex EpiFuse Catheter Connector, Portex Regional Anaesthesia Portfolio Filters K172410 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Smiths Medical Asd, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k172499/ 2018-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k172499-neoshield-fda-510k.jpg K172499 - NEOSHIELD K172499 is a FDA 510(k) cleared general hospital medical device. Manufacturer: JMS North America Corporation. Cleared Jun 2018. https://www.510kdatabase.net/k172765/ 2018-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k172765-smart-moves-complete-fda-510k.jpg K172765 - Smart Moves Complete K172765 is a FDA 510(k) cleared dental medical device. Manufacturer: Great Lakes Orthodontics, Ltd.. Cleared Jun 2018. https://www.510kdatabase.net/k173330/ 2018-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k173330-pannat-stec-test-fda-510k.jpg K173330 - PanNAT STEC Test K173330 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Micronics, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k173975/ 2018-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k173975-ufii-wide-fixture-fda-510k.jpg K173975 - UF(II) Wide Fixture K173975 is a FDA 510(k) cleared dental medical device. Manufacturer: Dio Corporation. Cleared Jun 2018. https://www.510kdatabase.net/k180026/ 2018-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k180026-bowel-management-device-bowel-fda-510k.jpg K180026 - Bowel Management Device, Bowel Management Irrigation Set K180026 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Applied Medical Technology, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k180045/ 2018-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k180045-omnipod-dash-insulin-management-system-fda-510k.jpg K180045 - Omnipod DASH Insulin Management System K180045 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Insulet Corporation. Cleared Jun 2018. https://www.510kdatabase.net/k180136/ 2018-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k180136-bionude-lubricant-fda-510k.jpg K180136 - BioNude Lubricant K180136 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Good Clean Love, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k180189/ 2018-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k180189-inmode-system-with-fractora3d3d-90-fda-510k.jpg K180189 - InMode System with Fractora3D/3D-90 Applicators K180189 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Inmode MD , Ltd.. Cleared Jun 2018. https://www.510kdatabase.net/k180238/ 2018-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k180238-carto-3-ep-navigation-system-version-fda-510k.jpg K180238 - CARTO 3 EP Navigation System, Version 6.0 and Accessories with VISITAG SURPOINT K180238 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biosense Webster, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k180325/ 2018-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k180325-single-use-multiclip-device-fda-510k.jpg K180325 - Single Use MultiClip Device K180325 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Micro-Tech (Nanjing) Co., Ltd.. Cleared Jun 2018. https://www.510kdatabase.net/k180617/ 2018-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k180617-hair-up-fda-510k.jpg K180617 - Hair Up K180617 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Y & J Bio Co., Ltd.. Cleared Jun 2018. https://www.510kdatabase.net/k180800/ 2018-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k180800-colonic-plus-regular-small-and-fda-510k.jpg K180800 - Colonic Plus Regular, Small, and Straight Shape Hydrokit K180800 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Colonic Plus. Cleared Jun 2018. https://www.510kdatabase.net/k180855/ 2018-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k180855-prevena-plus-incision-management-fda-510k.jpg K180855 - Prevena Plus Incision Management System, Prevena Plus Duo Incision Management System K180855 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Kci USA, Inc.. Cleared Jun 2018. https://www.510kdatabase.net/k170703/ 2018-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k170703-single-use-arthroscopic-electrode-with-fda-510k.jpg K170703 - Single Use Arthroscopic Electrode (with Pencil) K170703 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Modern Medical Equipment Manufacturing Limited. Cleared May 2018. https://www.510kdatabase.net/k171828/ 2018-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k171828-etco2-sensor-fda-510k.jpg K171828 - ETCO2 Sensor K171828 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Orantech, Inc.. Cleared May 2018. https://www.510kdatabase.net/k172690/ 2018-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k172690-tofscan-fda-510k.jpg K172690 - ToFscan K172690 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Idmed. Cleared May 2018. https://www.510kdatabase.net/k173415/ 2018-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k173415-endowrist-5mm-thoracic-grasper-fda-510k.jpg K173415 - EndoWrist 5mm Thoracic Grasper K173415 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared May 2018. https://www.510kdatabase.net/k173906/ 2018-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k173906-da-vinci-sp-surgical-system-endowrist-fda-510k.jpg K173906 - da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories K173906 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared May 2018. https://www.510kdatabase.net/k180464/ 2018-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k180464-aevumed-phantom-suture-anchors-fda-510k.jpg K180464 - AEVUMED PHANTOM Suture Anchors K180464 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aevumed, Inc.. Cleared May 2018. https://www.510kdatabase.net/k180480/ 2018-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k180480-atec-universal-spacer-system-fda-510k.jpg K180480 - ATEC Universal Spacer System K180480 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine, Inc.. Cleared May 2018. https://www.510kdatabase.net/k180582/ 2018-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k180582-sternal-cable-system-fda-510k.jpg K180582 - Sternal Cable System K180582 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: A & E Medical Corporation. Cleared May 2018. https://www.510kdatabase.net/k180606/ 2018-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k180606-somavac-device-fda-510k.jpg K180606 - SOMAVAC Device K180606 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Somavac Medical Solutions, Inc.. Cleared May 2018. https://www.510kdatabase.net/k181098/ 2018-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k181098-acuson-sc2000-diagnostic-ultrasound-fda-510k.jpg K181098 - ACUSON SC2000 Diagnostic Ultrasound System K181098 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 2018. https://www.510kdatabase.net/k181122/ 2018-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k181122-cardiosave-intra-aortic-balloon-pump-fda-510k.jpg K181122 - CARDIOSAVE Intra-Aortic Balloon Pump K181122 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared May 2018. https://www.510kdatabase.net/k181177/ 2018-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k181177-interventional-workspot-fda-510k.jpg K181177 - Interventional Workspot K181177 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared May 2018. https://www.510kdatabase.net/k171019/ 2018-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k171019-sciocardio-ecg-transmitter-fda-510k.jpg K171019 - ScioCardio ECG Transmitter K171019 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Synergen Technology Labs, LLC. Cleared May 2018. https://www.510kdatabase.net/k172825/ 2018-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k172825-mn-111-fda-510k.jpg K172825 - MN-111 K172825 is a FDA 510(k) cleared general hospital medical device. Manufacturer: W&H Sterilization S.R.L.. Cleared May 2018. https://www.510kdatabase.net/k173246/ 2018-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k173246-aneroid-sphygmomanometer-fda-510k.jpg K173246 - ANEROID SPHYGMOMANOMETER K173246 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Wenzhou Bokang Instruments Co., Ltd.. Cleared May 2018. https://www.510kdatabase.net/k173269/ 2018-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k173269-kator-suture-anchor-fda-510k.jpg K173269 - KATOR Suture Anchor K173269 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Kator, LLC. Cleared May 2018. https://www.510kdatabase.net/k173483/ 2018-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k173483-pure-flow-external-counter-pulsation-fda-510k.jpg K173483 - Pure Flow External Counter-Pulsation Device K173483 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Xtreem Pulse, LLC. Cleared May 2018. https://www.510kdatabase.net/k173951/ 2018-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k173951-legend-acetabular-liners-fda-510k.jpg K173951 - Legend Acetabular Liners K173951 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ortho Development Corporation. Cleared May 2018. https://www.510kdatabase.net/k180167/ 2018-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k180167-playtex-stella-tampons-fda-510k.jpg K180167 - Playtex Stella Tampons K180167 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Playtex Manufacturing, Inc.. Cleared May 2018. https://www.510kdatabase.net/k180293/ 2018-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k180293-retia-2-fda-510k.jpg K180293 - Retia 2 K180293 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Centervue S.P.A.. Cleared May 2018. https://www.510kdatabase.net/k180361/ 2018-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k180361-microraptor-regenesorb-suture-anchor-fda-510k.jpg K180361 - MICRORAPTOR REGENESORB Suture Anchor K180361 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith and Nephew, Inc.. Cleared May 2018. https://www.510kdatabase.net/k181188/ 2018-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k181188-everest-spinal-system-fda-510k.jpg K181188 - EVEREST Spinal System K181188 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: K2m, Inc.. Cleared May 2018. https://www.510kdatabase.net/k172871/ 2018-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k172871-spinekure-kyphoplasty-system-fda-510k.jpg K172871 - SpineKure Kyphoplasty System K172871 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Hanchang Co., Ltd.. Cleared May 2018. https://www.510kdatabase.net/k173157/ 2018-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k173157-drs-light2-fda-510k.jpg K173157 - Dr's Light2 K173157 is a FDA 510(k) cleared dental medical device. Manufacturer: Good Doctors Co., Ltd.. Cleared May 2018. https://www.510kdatabase.net/k180174/ 2018-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k180174-belun-ring-fda-510k.jpg K180174 - Belun Ring K180174 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Belun Technology Company Limited. Cleared May 2018. https://www.510kdatabase.net/k180553/ 2018-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k180553-verify-spore-test-strip-for-s40-fda-510k.jpg K180553 - VERIFY Spore Test Strip for S40 Sterilant K180553 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared May 2018. https://www.510kdatabase.net/k180572/ 2018-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k180572-aixplorer-mach-ultrasound-diagnostic-fda-510k.jpg K180572 - AIXPLORER MACH Ultrasound Diagnostic Systems Aixplorer Mach 30, Aixplorer Mach 20, Aixplorer Mach 10 K180572 is a FDA 510(k) cleared radiology medical device. Manufacturer: Supersonic Imagine. Cleared May 2018. https://www.510kdatabase.net/k181132/ 2018-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k181132-tri-ad-20-adams-tricuspid-band-fda-510k.jpg K181132 - Tri-Ad 2.0 Adams Tricuspid Band K181132 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic. Cleared May 2018. https://www.510kdatabase.net/k172147/ 2018-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k172147-star-65-fda-510k.jpg K172147 - STAR 65 K172147 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Skanray Technologies Pvt, Ltd.. Cleared May 2018. https://www.510kdatabase.net/k172242/ 2018-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k172242-dripassist-plus-fda-510k.jpg K172242 - DripAssist Plus K172242 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shift Labs, Inc.. Cleared May 2018. https://www.510kdatabase.net/k172717/ 2018-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k172717-automatic-tissue-processing-unit-fda-510k.jpg K172717 - Automatic Tissue Processing Unit K172717 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bsl Co.. Cleared May 2018. https://www.510kdatabase.net/k172889/ 2018-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k172889-infrared-thermometer-fda-510k.jpg K172889 - Infrared Thermometer K172889 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen Pacom Medical Instruments Co., Ltd.. Cleared May 2018. https://www.510kdatabase.net/k173005/ 2018-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k173005-surecell-gelling-fiber-wound-dressing-fda-510k.jpg K173005 - SURECELL Gelling Fiber Wound Dressing K173005 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Jiangsu Newvalue Medical Producst Co.,Ltd. Cleared May 2018. https://www.510kdatabase.net/k173834/ 2018-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k173834-quantum-pump-console-fda-510k.jpg K173834 - Quantum Pump Console K173834 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Spectrum Medical , Ltd.. Cleared May 2018. https://www.510kdatabase.net/k173914/ 2018-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k173914-vortran-cuff-inflator-vci-fda-510k.jpg K173914 - VORTRAN Cuff Inflator (VCI) K173914 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Vortran Medical Technology 1, Inc.. Cleared May 2018. https://www.510kdatabase.net/k180111/ 2018-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k180111-clearguard-hd-antimicrobial-barrier-cap-fda-510k.jpg K180111 - ClearGuard HD Antimicrobial Barrier Cap K180111 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Pursuit Vascular, Inc.. Cleared May 2018. https://www.510kdatabase.net/k180163/ 2018-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k180163-transenterix-senhance-surgical-system-fda-510k.jpg K180163 - TransEnterix Senhance Surgical System K180163 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Transenterix, Inc.. Cleared May 2018. https://www.510kdatabase.net/k180356/ 2018-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k180356-inui-in-home-urine-analysis-test-system-fda-510k.jpg K180356 - inui In-Home Urine Analysis Test System K180356 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Scanadu, Inc.. Cleared May 2018. https://www.510kdatabase.net/k180402/ 2018-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k180402-pslt-with-pascal-synthesis-pslt-with-fda-510k.jpg K180402 - PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar K180402 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Topcon Medical Laser Systems, Inc.. Cleared May 2018. https://www.510kdatabase.net/k180711/ 2018-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k180711-fujifilm-endoscopic-co2-regulator-gw-100-fda-510k.jpg K180711 - FUJIFILM Endoscopic CO2 Regulator GW-100 K180711 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fujifilm Corporation. Cleared May 2018. https://www.510kdatabase.net/k181082/ 2018-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k181082-advia-chemistry-cystatin-c2-assay-cysc2-fda-510k.jpg K181082 - ADVIA Chemistry Cystatin C_2 Assay (CYSC_2) K181082 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared May 2018. https://www.510kdatabase.net/k181150/ 2018-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k181150-protekduo-mini-veno-venous-cannula-set-fda-510k.jpg K181150 - ProtekDuo Mini Veno-Venous Cannula Set K181150 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cardiacassist, Inc.. Cleared May 2018. https://www.510kdatabase.net/k170697/ 2018-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k170697-gbr-system-fda-510k.jpg K170697 - GBR system K170697 is a FDA 510(k) cleared dental medical device. Manufacturer: Surgident. Cleared May 2018. https://www.510kdatabase.net/k172582/ 2018-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k172582-euroimmun-ifa-granulocyte-mosaic-fda-510k.jpg K172582 - EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPattern K172582 is a FDA 510(k) cleared immunology medical device. Manufacturer: Euroimmun Us, Inc.. Cleared May 2018. https://www.510kdatabase.net/k172665/ 2018-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k172665-classic-cotton-cannulatome-cannulatome-fda-510k.jpg K172665 - Classic Cotton Cannulatome®, CannulaTome II® Double Lumen Sphincterotome, Cotton CannulaTome II® PC, UTS® Ultra Taper Sphincterotome, Tri-Tome pc® Triple Lumen Sphincterotome, Howell D.A.S.H.® Sphincterotome with DomeTip®, Billroth II Sphincterotome, Soehendra® BII Sphincterotome, Models ACU-1 and ACU-1-VL active cords K172665 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Wilson-Cook Medical Inc./Cook Endoscopy. Cleared May 2018. https://www.510kdatabase.net/k172708/ 2018-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k172708-t2bacteria-panel-fda-510k.jpg K172708 - T2Bacteria Panel K172708 is a FDA 510(k) cleared microbiology medical device. Manufacturer: T2biosystems, Inc.. Cleared May 2018. https://www.510kdatabase.net/k173938/ 2018-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k173938-is-iii-hactive-fixture-fda-510k.jpg K173938 - IS-III HActive Fixture K173938 is a FDA 510(k) cleared dental medical device. Manufacturer: Neobiotech Co., Ltd.. Cleared May 2018. https://www.510kdatabase.net/k180414/ 2018-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k180414-epx-4440fn-digital-video-processor-fda-510k.jpg K180414 - EPX-4440FN Digital Video Processor with Light Source K180414 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fujifilm New Development U.S.A., Inc.. Cleared May 2018. https://www.510kdatabase.net/k180543/ 2018-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k180543-gc70-gu60agu60a-65-gf50-gf50a-gr40cw-fda-510k.jpg K180543 - GC70, GU60A&GU60A-65, GF50, GF50A, GR40CW, and GM85 K180543 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Electronics Co., Ltd.. Cleared May 2018. https://www.510kdatabase.net/k180756/ 2018-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k180756-safety-wire-guide-introducer-fda-510k.jpg K180756 - Safety Wire Guide Introducer K180756 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared May 2018. https://www.510kdatabase.net/k180807/ 2018-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k180807-celling-aspiration-needle-fda-510k.jpg K180807 - Celling Aspiration Needle K180807 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Spine Smith Holdings, LLC. Cleared May 2018. https://www.510kdatabase.net/k180862/ 2018-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k180862-acclarix-lx8-diagnostic-ultrasound-fda-510k.jpg K180862 - Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound System K180862 is a FDA 510(k) cleared radiology medical device. Manufacturer: Edan Instruments, Inc.. Cleared May 2018. https://www.510kdatabase.net/k180976/ 2018-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k180976-pixx-1717-fda-510k.jpg K180976 - PIXX 1717 K180976 is a FDA 510(k) cleared radiology medical device. Manufacturer: Pixxgen Corporation. Cleared May 2018. https://www.510kdatabase.net/k181077/ 2018-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k181077-actigraph-centrepoint-insight-watch-fda-510k.jpg K181077 - ActiGraph CentrePoint Insight Watch K181077 is a FDA 510(k) cleared neurology medical device. Manufacturer: Actigraph. Cleared May 2018. https://www.510kdatabase.net/k181080/ 2018-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k181080-mckesson-cardiology-fda-510k.jpg K181080 - McKesson Cardiology K181080 is a FDA 510(k) cleared radiology medical device. Manufacturer: Change Healthcare Israel , Ltd.. Cleared May 2018. https://www.510kdatabase.net/k181108/ 2018-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k181108-fresenius-liberty-select-cycler-fda-510k.jpg K181108 - Fresenius Liberty Select Cycler K181108 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC. Cleared May 2018. https://www.510kdatabase.net/k181136/ 2018-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k181136-cs-9600-fda-510k.jpg K181136 - CS 9600 K181136 is a FDA 510(k) cleared radiology medical device. Manufacturer: Trophy. Cleared May 2018. https://www.510kdatabase.net/den180005/ 2018-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/den180005-osteodetect-fda-510k.jpg DEN180005 - OsteoDetect DEN180005 is a FDA 510(k) cleared radiology medical device. Manufacturer: Imagen Technologies, Inc.. Cleared May 2018. https://www.510kdatabase.net/k173722/ 2018-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k173722-patriot-colonial-spacer-sustain-spacer-fda-510k.jpg K173722 - PATRIOT COLONIAL Spacer, SUSTAIN Spacer K173722 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared May 2018. https://www.510kdatabase.net/k180201/ 2018-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k180201-route-92-medical-access-system-fda-510k.jpg K180201 - Route 92 Medical Access System K180201 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Route 92 Medical, Inc.. Cleared May 2018. https://www.510kdatabase.net/k180403/ 2018-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k180403-enseal-x1-tissue-sealer-curved-jaw-fda-510k.jpg K180403 - ENSEAL X1 Tissue Sealer, Curved Jaw, Articulating 37 cm Shaft Length K180403 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon Endo-Surgery, LLC. Cleared May 2018. https://www.510kdatabase.net/k180609/ 2018-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k180609-rodo-smilekey-fda-510k.jpg K180609 - Rodo Smilekey K180609 is a FDA 510(k) cleared dental medical device. Manufacturer: Rodo Medical, Inc.. Cleared May 2018. https://www.510kdatabase.net/k180811/ 2018-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k180811-biograph-vision-fda-510k.jpg K180811 - Biograph Vision K180811 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 2018. https://www.510kdatabase.net/k181024/ 2018-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k181024-dus-2gp-reagent-strips-dus-5-reagent-fda-510k.jpg K181024 - DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent Strips K181024 is a FDA 510(k) cleared chemistry medical device. Manufacturer: DFI Co., Ltd.. Cleared May 2018. https://www.510kdatabase.net/k181059/ 2018-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k181059-geko-t-3-neuromuscular-stimulator-fda-510k.jpg K181059 - geko T-3 Neuromuscular Stimulator K181059 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Firstkind Limited. Cleared May 2018. https://www.510kdatabase.net/k181067/ 2018-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k181067-alignx-ankle-fusion-system-fda-510k.jpg K181067 - AlignX Ankle Fusion System K181067 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Extremity Medical, LLC. Cleared May 2018. https://www.510kdatabase.net/k173405/ 2018-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k173405-dilumen-endolumenal-interventional-fda-510k.jpg K173405 - DiLumen Endolumenal Interventional Scissors (DiLumen Is) K173405 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lumendi, LLC. Cleared May 2018. https://www.510kdatabase.net/k173862/ 2018-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k173862-pantheris-system-fda-510k.jpg K173862 - Pantheris System K173862 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Avinger, Inc.. Cleared May 2018. https://www.510kdatabase.net/k180270/ 2018-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k180270-cellvizio-100-series-systems-with-fda-510k.jpg K180270 - Cellvizio 100 Series Systems with Confocal Miniprobes K180270 is a FDA 510(k) cleared neurology medical device. Manufacturer: Mauna Kea Technologies. Cleared May 2018. https://www.510kdatabase.net/k180455/ 2018-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k180455-neuralbot-fda-510k.jpg K180455 - NeuralBot K180455 is a FDA 510(k) cleared radiology medical device. Manufacturer: Neural Analytics, Inc.. Cleared May 2018. https://www.510kdatabase.net/k180662/ 2018-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k180662-arthrex-fastthread-interference-screw-fda-510k.jpg K180662 - Arthrex FastThread Interference Screw K180662 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared May 2018. https://www.510kdatabase.net/k180773/ 2018-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k180773-reusable-and-self-adhesive-electrodes-fda-510k.jpg K180773 - Reusable and Self-Adhesive Electrodes K180773 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shaoxing Dongzhi Electrical Technology Co., Ltd.. Cleared May 2018. https://www.510kdatabase.net/k180808/ 2018-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k180808-omni-foot-plating-system-fda-510k.jpg K180808 - Omni Foot Plating System K180808 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Extremity Medical, LLC. Cleared May 2018. https://www.510kdatabase.net/k172729/ 2018-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k172729-polypectomy-snare-fda-510k.jpg K172729 - Polypectomy Snare K172729 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hangzhou AGS MedTech Co., Ltd.. Cleared May 2018. https://www.510kdatabase.net/k173395/ 2018-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k173395-mecall-clisis-systems-discovery-rf180-fda-510k.jpg K173395 - MECALL CLISIS SYSTEMS, Discovery RF180 K173395 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Medical Merate S.P.A. Cleared May 2018. https://www.510kdatabase.net/k173593/ 2018-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k173593-staysafe-catheter-extension-set-with-fda-510k.jpg K173593 - stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 6 inch, stay•safe catheter extension set with Luer-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 18 inch, stay•safe to Luer-Lock adapter, 4 inch K173593 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC. Cleared May 2018. https://www.510kdatabase.net/k173956/ 2018-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k173956-biowy-plcc-catheter-fda-510k.jpg K173956 - Biowy PlCC Catheter K173956 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Biowy Corporation. Cleared May 2018. https://www.510kdatabase.net/k180197/ 2018-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k180197-erchonia-fx-635-fda-510k.jpg K180197 - Erchonia FX-635 K180197 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Erchonia Corporation. Cleared May 2018. https://www.510kdatabase.net/k180220/ 2018-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k180220-sagico-osi-spinal-system-by-osimplant-fda-510k.jpg K180220 - SAGICO OSI Spinal System by Osimplant K180220 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinal Analytics & Geometrical Implant Co, LLC. Cleared May 2018. https://www.510kdatabase.net/k180545/ 2018-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k180545-vacuette-safelink-holder-with-male-fda-510k.jpg K180545 - VACUETTE SAFELINK Holder with male luer lock K180545 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Greiner Bio-One Na, Inc.. Cleared May 2018. https://www.510kdatabase.net/k180817/ 2018-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k180817-aerial-interspinous-fixation-fda-510k.jpg K180817 - AERIAL™ Interspinous Fixation K180817 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared May 2018. https://www.510kdatabase.net/k172209/ 2018-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k172209-aura-icp-monitoring-system-fda-510k.jpg K172209 - AURA ICP MONITORING SYSTEM K172209 is a FDA 510(k) cleared neurology medical device. Manufacturer: Branchpoint Technologies, Inc.. Cleared May 2018. https://www.510kdatabase.net/k172430/ 2018-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k172430-argenis-titanium-abutments-fda-510k.jpg K172430 - ArgenIS Titanium Abutments K172430 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Corporation. Cleared May 2018. https://www.510kdatabase.net/k172813/ 2018-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k172813-esophageal-stent-system-fda-510k.jpg K172813 - Esophageal Stent System K172813 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Micro-Tech (Nanjing) Co., Ltd.. Cleared May 2018. https://www.510kdatabase.net/k173108/ 2018-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k173108-smoklean-fda-510k.jpg K173108 - Smoklean K173108 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sejong Medical Co., Ltd.. Cleared May 2018. https://www.510kdatabase.net/k173110/ 2018-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k173110-graftsite-fda-510k.jpg K173110 - GRAFTSITE K173110 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Summit Medical , Ltd.. Cleared May 2018. https://www.510kdatabase.net/k173294/ 2018-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k173294-magnesium-fda-510k.jpg K173294 - Magnesium K173294 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared May 2018. https://www.510kdatabase.net/k173431/ 2018-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k173431-towako-transmyometrial-embryo-transfer-fda-510k.jpg K173431 - Towako Transmyometrial Embryo Transfer Set K173431 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: William A. Cook Australia Pty. , Ltd.. Cleared May 2018. https://www.510kdatabase.net/k180051/ 2018-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k180051-xstat-30-1-pack-fda-510k.jpg K180051 - XSTAT 30, 1-Pack K180051 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Revmedx, Inc.. Cleared May 2018. https://www.510kdatabase.net/k180087/ 2018-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k180087-am-surgical-intramedullary-fixation-fda-510k.jpg K180087 - A.M. Surgical Intramedullary Fixation Device K180087 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: A.M. Surgical, Inc.. Cleared May 2018. https://www.510kdatabase.net/k180217/ 2018-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k180217-vestex-apparel-fda-510k.jpg K180217 - VESTEX Apparel K180217 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Vestagen Protective Technologies, Inc.. Cleared May 2018. https://www.510kdatabase.net/k180259/ 2018-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k180259-sterile-hypodermic-needle-for-single-use-fda-510k.jpg K180259 - Sterile Hypodermic Needle for Single Use K180259 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu Shenli Medical Production Co., Ltd.. Cleared May 2018. https://www.510kdatabase.net/k180375/ 2018-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k180375-the-iqooltm-warm-system-fda-510k.jpg K180375 - The IQoolTM Warm System K180375 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Braincool AB. Cleared May 2018. https://www.510kdatabase.net/k180460/ 2018-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k180460-theradome-lh40-fda-510k.jpg K180460 - Theradome LH40 K180460 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Theradome, Inc.. Cleared May 2018. https://www.510kdatabase.net/k180508/ 2018-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k180508-joule-system-fda-510k.jpg K180508 - JOULE SYSTEM K180508 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sciton, Inc. Cleared May 2018. https://www.510kdatabase.net/k180524/ 2018-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k180524-eeg-now-fda-510k.jpg K180524 - EEG-Now K180524 is a FDA 510(k) cleared neurology medical device. Manufacturer: Encephalodynamics, Inc.. Cleared May 2018. https://www.510kdatabase.net/k180663/ 2018-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k180663-lavid-fmts-diagnostic-x-ray-system-fda-510k.jpg K180663 - LaVid FMTS DIAGNOSTIC X-RAY SYSTEM K180663 is a FDA 510(k) cleared radiology medical device. Manufacturer: Livermoretech, Inc.. Cleared May 2018. https://www.510kdatabase.net/k180700/ 2018-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k180700-kyphon-hv-r-bone-cement-fda-510k.jpg K180700 - KYPHON HV-R Bone Cement K180700 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared May 2018. https://www.510kdatabase.net/k180771/ 2018-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k180771-acro-hcg-pregnancy-rapid-test-fda-510k.jpg K180771 - Acro HCG Pregnancy Rapid Test K180771 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Acro Biotech, Inc.. Cleared May 2018. https://www.510kdatabase.net/k180876/ 2018-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k180876-dtrax-spinal-system-fda-510k.jpg K180876 - DTRAX Spinal System K180876 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Providence Medical Technology, Inc.. Cleared May 2018. https://www.510kdatabase.net/k180886/ 2018-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k180886-liofilchem-mic-test-strip-mts-fda-510k.jpg K180886 - Liofilchem MIC Test Strip (MTS), Delafloxacin 0.002 - 32 ug/mL K180886 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Liofilchem S. R. L.. Cleared May 2018. https://www.510kdatabase.net/k180908/ 2018-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k180908-irrigation-tubing-bipolar-cord-set-fda-510k.jpg K180908 - Irrigation Tubing Bipolar Cord Set K180908 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: New Deantronics Taiwan , Ltd.. Cleared May 2018. https://www.510kdatabase.net/k181145/ 2018-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k181145-eclipse-treatment-planning-system-fda-510k.jpg K181145 - Eclipse Treatment Planning System K181145 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared May 2018. https://www.510kdatabase.net/k181179/ 2018-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k181179-brainscope-one-fda-510k.jpg K181179 - BrainScope One K181179 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainscope Company, Inc.. Cleared May 2018. https://www.510kdatabase.net/k171505/ 2018-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k171505-dimesol-disposable-av-fistula-needle-fda-510k.jpg K171505 - Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series) K171505 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Dimesol, Inc.. Cleared May 2018. https://www.510kdatabase.net/k172480/ 2018-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k172480-icotec-interbody-cage-system-fda-510k.jpg K172480 - icotec Interbody Cage System K172480 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Icotec AG. Cleared May 2018. https://www.510kdatabase.net/k172524/ 2018-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k172524-zimmer-persona-personalized-knee-system-fda-510k.jpg K172524 - Zimmer Persona Personalized Knee System K172524 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared May 2018. https://www.510kdatabase.net/k172592/ 2018-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k172592-cadd-yellow-high-volume-administration-fda-510k.jpg K172592 - CADD Yellow High Volume Administration Set with NRFit connector K172592 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Smiths Medical Asd, Inc.. Cleared May 2018. https://www.510kdatabase.net/k172894/ 2018-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k172894-infrared-thermometer-fda-510k.jpg K172894 - Infrared Thermometer K172894 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen Jiacom Technology CO ., Ltd.. Cleared May 2018. https://www.510kdatabase.net/k173360/ 2018-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k173360-athena-190-fda-510k.jpg K173360 - Athena 190 K173360 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Medical Rehab Products, LLC. Cleared May 2018. https://www.510kdatabase.net/k173667/ 2018-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k173667-155f-x-19-cm-symetrex-long-term-fda-510k.jpg K173667 - 15.5F X 19 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 23 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 28 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 33 cm Symetrex Long Term Hemodialysis Catheter with Sideholes, 15.5F X 37 cm Symetrex Long Term Hemodialysis Catheter with Sideholes K173667 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medical Components, Inc. (dba MedComp). Cleared May 2018. https://www.510kdatabase.net/k173832/ 2018-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k173832-intice-c-porous-ti-cervical-interbody-fda-510k.jpg K173832 - InTice™-C Porous Ti Cervical Interbody System K173832 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: X-Spine Systems, Inc.. Cleared May 2018. https://www.510kdatabase.net/k173931/ 2018-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k173931-mindmotiontm-go-fda-510k.jpg K173931 - MindMotion(TM) GO K173931 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Mindmaze SA. Cleared May 2018. https://www.510kdatabase.net/k180466/ 2018-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k180466-flowtriever-retrievalaspiration-system-fda-510k.jpg K180466 - FlowTriever Retrieval/Aspiration System K180466 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inari Medical, Inc.. Cleared May 2018. https://www.510kdatabase.net/k180742/ 2018-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k180742-ensoetm-fda-510k.jpg K180742 - EnsoETM K180742 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Advanced Cooling Therapy, Inc. D/B/A Attune Medical. Cleared May 2018. https://www.510kdatabase.net/k181023/ 2018-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k181023-mozec-rx-ptca-balloon-dilatation-fda-510k.jpg K181023 - Mozec – Rx PTCA Balloon Dilatation Catheter, Mozec NC – Rx PTCA Balloon Dilatation Catheter K181023 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Meril Life Sciences Private Limited. Cleared May 2018. https://www.510kdatabase.net/k181042/ 2018-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k181042-ultra-ice-plus-pi-9-mhz-peripheral-fda-510k.jpg K181042 - Ultra ICE Plus – PI 9 MHz Peripheral Imaging Catheter K181042 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared May 2018. https://www.510kdatabase.net/k181111/ 2018-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k181111-navigated-infinity-instruments-fda-510k.jpg K181111 - Navigated INFINITY Instruments K181111 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared May 2018. https://www.510kdatabase.net/den170086/ 2018-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/den170086-truetear-intranasal-tear-neurostimulator-fda-510k.jpg DEN170086 - TrueTear Intranasal Tear Neurostimulator DEN170086 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Allergan. Cleared May 2018. https://www.510kdatabase.net/k172675/ 2018-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k172675-varian-cervical-sleeves-fda-510k.jpg K172675 - Varian Cervical Sleeves K172675 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared May 2018. https://www.510kdatabase.net/k180239/ 2018-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k180239-additive-orthopaedics-patient-specific-fda-510k.jpg K180239 - Additive Orthopaedics Patient Specific 3D Printed Bone Segments K180239 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Additive Orthopaedics, LLC. Cleared May 2018. https://www.510kdatabase.net/k180519/ 2018-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k180519-harrier-sa-lumbar-interbody-system-fda-510k.jpg K180519 - HARRIER-SA™ Lumbar Interbody System K180519 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Choicespine, LP. Cleared May 2018. https://www.510kdatabase.net/k180527/ 2018-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k180527-is3-fda-510k.jpg K180527 - IS3 K180527 is a FDA 510(k) cleared dental medical device. Manufacturer: Hiossen, Inc.. Cleared May 2018. https://www.510kdatabase.net/k180819/ 2018-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k180819-one-day-flat-pack-hioxifilcon-a-daily-fda-510k.jpg K180819 - One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens K180819 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Menicon Co, Ltd.. Cleared May 2018. https://www.510kdatabase.net/k180901/ 2018-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k180901-low-dose-ct-lung-cancer-screening-option-fda-510k.jpg K180901 - Low Dose CT Lung Cancer Screening Option K180901 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hitachi Healthcare Americas. Cleared May 2018. https://www.510kdatabase.net/k180906/ 2018-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k180906-conformis-itotal-cruciate-retaining-cr-fda-510k.jpg K180906 - Conformis iTotal Cruciate Retaining (CR) Knee Replacement System K180906 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Conformis, Inc.. Cleared May 2018. https://www.510kdatabase.net/k171449/ 2018-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k171449-metacem-fda-510k.jpg K171449 - Metacem K171449 is a FDA 510(k) cleared dental medical device. Manufacturer: Meta Biomed Co., Ltd.. Cleared May 2018. https://www.510kdatabase.net/k173940/ 2018-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k173940-astroid-planning-app-fda-510k.jpg K173940 - Astroid Planning App K173940 is a FDA 510(k) cleared radiology medical device. Manufacturer: .Decimal, LLC. Cleared May 2018. https://www.510kdatabase.net/k180412/ 2018-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k180412-indigo-aspiration-system-cat-rx-and-fda-510k.jpg K180412 - Indigo Aspiration System (CAT RX and Separator 4)- Penumbra Engine Pump and Canister K180412 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Penumbra, Inc.. Cleared May 2018. https://www.510kdatabase.net/k180445/ 2018-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k180445-revive-light-therapy-led-ultrasonic-fda-510k.jpg K180445 - reVive Light Therapy LED Ultrasonic Wrinkle System K180445 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Led Technologies, Inc.. Cleared May 2018. https://www.510kdatabase.net/k180476/ 2018-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k180476-powder-free-nitrile-examination-gloves-fda-510k.jpg K180476 - Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs K180476 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Comfort Rubber Gloves Industries Sdn. Bhd.. Cleared May 2018. https://www.510kdatabase.net/k180513/ 2018-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k180513-customizedbone-service-fda-510k.jpg K180513 - CustomizedBone Service K180513 is a FDA 510(k) cleared neurology medical device. Manufacturer: Fin-Ceramica Faenza S.P.A.. Cleared May 2018. https://www.510kdatabase.net/k180624/ 2018-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k180624-guided-growth-plate-system-plus-fda-510k.jpg K180624 - Guided Growth Plate System Plus K180624 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthofix Srl. Cleared May 2018. https://www.510kdatabase.net/k180687/ 2018-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k180687-reliance-lumber-ibf-system-fda-510k.jpg K180687 - Reliance Lumber IBF System K180687 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Reliance Medical Systems. Cleared May 2018. https://www.510kdatabase.net/k180883/ 2018-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k180883-5d-viewer-fda-510k.jpg K180883 - 5D Viewer K180883 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Medison Co., Ltd.. Cleared May 2018. https://www.510kdatabase.net/k180986/ 2018-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k180986-xablecath-support-catheter-product-fda-510k.jpg K180986 - XableCath Support Catheter Product Family K180986 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Xablecath, Inc.. Cleared May 2018. https://www.510kdatabase.net/k181003/ 2018-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k181003-vivix-s-1717v-fda-510k.jpg K181003 - VIVIX-S 1717V K181003 is a FDA 510(k) cleared radiology medical device. Manufacturer: Vieworks Co., Ltd.. Cleared May 2018. https://www.510kdatabase.net/k181153/ 2018-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k181153-icefx-cryoablation-system-fda-510k.jpg K181153 - ICEfx Cryoablation System K181153 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Galil Medical, Inc.. Cleared May 2018. https://www.510kdatabase.net/k172640/ 2018-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k172640-dentium-implantium-superline-prosthetics-fda-510k.jpg K172640 - Dentium Implantium & SuperLine Prosthetics K172640 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentium Co., Ltd.. Cleared May 2018. https://www.510kdatabase.net/k173279/ 2018-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k173279-reli-safety-blood-collection-tube-fda-510k.jpg K173279 - RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube Holder K173279 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Myco Medical Supplies, Inc.. Cleared May 2018. https://www.510kdatabase.net/k173576/ 2018-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k173576-pristina-serena-fda-510k.jpg K173576 - Pristina Serena K173576 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared May 2018. https://www.510kdatabase.net/k173758/ 2018-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k173758-disposable-biopsy-valve-fda-510k.jpg K173758 - Disposable Biopsy Valve K173758 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Zhejiang Chuangxiang Medical Technology Co., Ltd.. Cleared May 2018. https://www.510kdatabase.net/k173810/ 2018-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k173810-ventripoint-medical-system-plus-vms-fda-510k.jpg K173810 - Ventripoint Medical System Plus (VMS+) K173810 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ventripoint Diagnostics , Ltd.. Cleared May 2018. https://www.510kdatabase.net/k180686/ 2018-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k180686-seaspine-daytona-small-stature-spinal-fda-510k.jpg K180686 - SeaSpine Daytona Small Stature Spinal System K180686 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared May 2018. https://www.510kdatabase.net/k180799/ 2018-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k180799-clarius-ultrasound-scanner-fda-510k.jpg K180799 - Clarius Ultrasound Scanner K180799 is a FDA 510(k) cleared radiology medical device. Manufacturer: Clarius Mobile Health Corp.. Cleared May 2018. https://www.510kdatabase.net/k170663/ 2018-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k170663-foremount-disposable-pvc-resuscitator-fda-510k.jpg K170663 - Foremount Disposable PVC Resuscitator, Foremount Disposable PEEP Valve, Foremount Disposable Manometer K170663 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Foremount Enterprise Co., Ltd.. Cleared May 2018. https://www.510kdatabase.net/k172510/ 2018-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k172510-cor-heart-failure-and-arrhythmia-fda-510k.jpg K172510 - µCor Heart Failure and Arrhythmia Management System K172510 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Zoll Manufacturing Corporation. Cleared May 2018. https://www.510kdatabase.net/k172517/ 2018-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k172517-seaspine-navigation-system-fda-510k.jpg K172517 - SeaSpine Navigation System K172517 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared May 2018. https://www.510kdatabase.net/k172570/ 2018-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k172570-algs6-ag-alginate-wound-dressing-fda-510k.jpg K172570 - ALGS6 Ag Alginate Wound Dressing K172570 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Foshan United Medical Technologies, Ltd.. Cleared May 2018. https://www.510kdatabase.net/k172625/ 2018-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k172625-reusable-finger-clip-nonin-medical-co-fda-510k.jpg K172625 - Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor K172625 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Nonin Medical, Inc.. Cleared May 2018. https://www.510kdatabase.net/k172719/ 2018-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k172719-healthbeacon-hb2-sharps-bin-fda-510k.jpg K172719 - HealthBeacon HB2 Sharps Bin K172719 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Healthbeacon, Ltd.. Cleared May 2018. https://www.510kdatabase.net/k173084/ 2018-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k173084-spectrum-iq-infusion-system-dose-iq-fda-510k.jpg K173084 - Spectrum IQ Infusion System, Dose IQ Safety Software K173084 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corporation. Cleared May 2018. https://www.510kdatabase.net/k173264/ 2018-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k173264-embryoscope-fda-510k.jpg K173264 - EmbryoScope+ K173264 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Vitrolife A/S. Cleared May 2018. https://www.510kdatabase.net/k180287/ 2018-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k180287-gsi-corti-fda-510k.jpg K180287 - GSI Corti K180287 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Grason-Stadler, Inc.. Cleared May 2018. https://www.510kdatabase.net/k180383/ 2018-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k180383-light-based-hair-removal-device-fda-510k.jpg K180383 - Light based hair removal device K180383 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Gsd Tech Co., Ltd.. Cleared May 2018. https://www.510kdatabase.net/k180385/ 2018-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k180385-infrared-body-thermometer-fda-510k.jpg K180385 - Infrared Body Thermometer K180385 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hetaida Technology Co., Ltd.. Cleared May 2018. https://www.510kdatabase.net/k180409/ 2018-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k180409-hs40-diagnostic-ultrasound-system-fda-510k.jpg K180409 - HS40 Diagnostic Ultrasound System K180409 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Medison Co., Ltd.. Cleared May 2018. https://www.510kdatabase.net/k180585/ 2018-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k180585-collagentex-rx-6-fda-510k.jpg K180585 - Collagentex Rx-6 K180585 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Tanses Technologies, Inc.. Cleared May 2018. https://www.510kdatabase.net/k180727/ 2018-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k180727-lineup-fda-510k.jpg K180727 - LineUp K180727 is a FDA 510(k) cleared radiology medical device. Manufacturer: Curvebeam, LLC. Cleared May 2018. https://www.510kdatabase.net/k180776/ 2018-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k180776-cytal-wound-particulate-fda-510k.jpg K180776 - Cytal Wound Particulate K180776 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Acell, Inc.. Cleared May 2018. https://www.510kdatabase.net/k172583/ 2018-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k172583-orthopediatrics-pedinail-fda-510k.jpg K172583 - OrthoPediatrics PediNail Intramedullary Platform K172583 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthopediatrics, Inc.. Cleared May 2018. https://www.510kdatabase.net/k172867/ 2018-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k172867-nitrile-examination-powder-free-glove-fda-510k.jpg K172867 - Nitrile Examination Powder Free Glove, Black, Nitrile Examination Powder Free Glove, Orange K172867 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Gmp Medicare Sdn Bhd (F25). Cleared May 2018. https://www.510kdatabase.net/k172882/ 2018-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k172882-uincare-home-fda-510k.jpg K172882 - UINCARE HOME K172882 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Uincare Corp.. Cleared May 2018. https://www.510kdatabase.net/k173012/ 2018-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k173012-angio-press-lite-dvt-compression-device-fda-510k.jpg K173012 - ANGIO-PRESS LITE DVT Compression Device K173012 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Pegasus Medical Supply, Inc.. Cleared May 2018. https://www.510kdatabase.net/k173391/ 2018-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k173391-osteomed-quickfix-hybrid-mmf-fda-510k.jpg K173391 - OsteoMed QuickFix Hybrid MMF Sterilization Tray K173391 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Osteomed, LLC. Cleared May 2018. https://www.510kdatabase.net/k173972/ 2018-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k173972-2008t-bluestar-hemodialysis-machine-fda-510k.jpg K173972 - 2008T BlueStar Hemodialysis Machine K173972 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC. Cleared May 2018. https://www.510kdatabase.net/k180003/ 2018-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k180003-fore-sight-elite-module-tissue-oximeter-fda-510k.jpg K180003 - FORE-SIGHT ELITE Module Tissue Oximeter K180003 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cas Medical Systems, Inc.. Cleared May 2018. https://www.510kdatabase.net/k180101/ 2018-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k180101-healix-advance-knotless-br-anchor-fda-510k.jpg K180101 - HEALIX ADVANCE KNOTLESS BR Anchor K180101 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International SARL. Cleared May 2018. https://www.510kdatabase.net/k180360/ 2018-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k180360-oktagon-implant-system-fda-510k.jpg K180360 - OKTAGON Implant System K180360 is a FDA 510(k) cleared dental medical device. Manufacturer: Hager& Meisinger GmbH. Cleared May 2018. https://www.510kdatabase.net/k180625/ 2018-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k180625-rondek-pga-suture-beige-or-violet-fda-510k.jpg K180625 - Rondek PGA Suture (Beige or Violet) K180625 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Rk Manufacturing Corporation. Cleared May 2018. https://www.510kdatabase.net/k180642/ 2018-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k180642-pro-link-ti-stand-alone-cervical-fda-510k.jpg K180642 - Pro-Link® Ti Stand-Alone Cervical Spacer System K180642 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared May 2018. https://www.510kdatabase.net/k180937/ 2018-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k180937-graftgun-universal-graft-delivery-system-fda-510k.jpg K180937 - Graftgun Universal Graft Delivery System K180937 is a FDA 510(k) cleared general hospital medical device. Manufacturer: SurGenTec, LLC. Cleared May 2018. https://www.510kdatabase.net/k180961/ 2018-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k180961-radiforce-mx194-fda-510k.jpg K180961 - RadiForce MX194 K180961 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eizo Corporation. Cleared May 2018. https://www.510kdatabase.net/k172145/ 2018-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k172145-invia-foam-dressing-kits-with-fitpad-fda-510k.jpg K172145 - Invia Foam Dressing Kits With FitPad, Invia Motion Negative Pressure Wound Therapy System (Invia Motion - Endure, Invia Motion – 120 days, Invia Motion – 60 days, Invia Motion – 30 days, Invia Motion – 15 days, Invia Motion – 7 days), Invia Liberty Negative Pressure Wound Therapy System, Invia Gauze Dressing Kits with FitPad K172145 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medela AG. Cleared May 2018. https://www.510kdatabase.net/k172191/ 2018-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k172191-sterizone-vp4-sterilizer-fda-510k.jpg K172191 - STERIZONE VP4 Sterilizer K172191 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Tso3, Inc.. Cleared May 2018. https://www.510kdatabase.net/k173202/ 2018-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k173202-cp3000-coagulation-analyzer-coagpia-at-fda-510k.jpg K173202 - CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set K173202 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sekisui Medical Co., Ltd.. Cleared May 2018. https://www.510kdatabase.net/k173309/ 2018-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k173309-faxitron-visionct-fda-510k.jpg K173309 - Faxitron VisionCT K173309 is a FDA 510(k) cleared radiology medical device. Manufacturer: Faxitron Bioptics, LLC. Cleared May 2018. https://www.510kdatabase.net/k173311/ 2018-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k173311-arthro-pump-pa304-fda-510k.jpg K173311 - ARTHRO-Pump PA304 K173311 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: W.O.M. World of Medicine GmbH. Cleared May 2018. https://www.510kdatabase.net/k173452/ 2018-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k173452-embotrap-ll-revascularization-device-fda-510k.jpg K173452 - EmboTrap ll Revascularization Device K173452 is a FDA 510(k) cleared neurology medical device. Manufacturer: Neuravi, Ltd.. Cleared May 2018. https://www.510kdatabase.net/k173572/ 2018-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k173572-dsm-biomedical-calcium-phosphate-fda-510k.jpg K173572 - DSM Biomedical Calcium Phosphate Cement with Microspheres K173572 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Kensey Nash Corporation Dba Dsm Biomedical. Cleared May 2018. https://www.510kdatabase.net/k180279/ 2018-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k180279-silkn-model-h5003-device-fda-510k.jpg K180279 - Silk'n MODEL H5003 device K180279 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Home Skinovations , Ltd.. Cleared May 2018. https://www.510kdatabase.net/k180461/ 2018-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k180461-navi-enavi-snavi-x-diagnostic-fda-510k.jpg K180461 - Navi e/Navi s/Navi X Diagnostic Ultrasound System K180461 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Wisonic Medical Technology Co. , Ltd.. Cleared May 2018. https://www.510kdatabase.net/k180913/ 2018-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k180913-vsi-micro-introducer-kit-fda-510k.jpg K180913 - VSI Micro-Introducer Kit K180913 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vascular Solutions, Inc.. Cleared May 2018. https://www.510kdatabase.net/k180929/ 2018-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k180929-klassic-hd-hip-system-fda-510k.jpg K180929 - Klassic HD® Hip System K180929 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Total Joint Orthopedics, Inc.. Cleared May 2018. https://www.510kdatabase.net/k180932/ 2018-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k180932-diamond-orthopedic-bone-fixation-fda-510k.jpg K180932 - Diamond Orthopedic Bone Fixation Screws and Pins K180932 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Diamond Orthopedic, LLC. Cleared May 2018. https://www.510kdatabase.net/k181032/ 2018-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k181032-halcyon-fda-510k.jpg K181032 - Halcyon K181032 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared May 2018. https://www.510kdatabase.net/k171690/ 2018-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k171690-trident-extremity-fixation-system-fda-510k.jpg K171690 - Trident Extremity Fixation System K171690 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Trident Orthopedics. Cleared May 2018. https://www.510kdatabase.net/k172471/ 2018-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k172471-ventana-cd30-ber-h2-rxdx-assay-fda-510k.jpg K172471 - VENTANA CD30 (Ber-H2) RxDx Assay K172471 is a FDA 510(k) cleared medical genetics medical device. Manufacturer: Ventana Medical Systems, Inc.. Cleared May 2018. https://www.510kdatabase.net/k172484/ 2018-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k172484-a-cift-solofuse-fda-510k.jpg K172484 - A-CIFT SoloFuse K172484 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinefrontier, Inc.. Cleared May 2018. https://www.510kdatabase.net/k172661/ 2018-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k172661-fetzer-medical-gynecological-forceps-fda-510k.jpg K172661 - Fetzer Medical Gynecological Forceps K172661 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Fetzer Medical GmbH & Co. KG. Cleared May 2018. https://www.510kdatabase.net/k173004/ 2018-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k173004-sb-soft-hood-straight-type-sb-soft-fda-510k.jpg K173004 - SB Soft Hood - Straight type, SB Soft Hood - Undercut type K173004 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Sumitomo Bakelite Co., Ltd.. Cleared May 2018. https://www.510kdatabase.net/k173347/ 2018-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k173347-stalif-c-flx-stalif-m-flx-stalif-l-flx-fda-510k.jpg K173347 - STALIF C FLX, STALIF M FLX, STALIF L FLX and STALIF Lateral-Oblique FLX, ACTILIF C FLX, ACTILIF M FLX, ACTILIF L FLX and ACTILIF Lateral-Oblique FLX K173347 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Centinel Spine, Inc.. Cleared May 2018. https://www.510kdatabase.net/k173510/ 2018-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k173510-biostamp-npoint-fda-510k.jpg K173510 - BioStamp nPoint K173510 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Mc10, Inc.. Cleared May 2018. https://www.510kdatabase.net/k173831/ 2018-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k173831-glidesheath-slender-fda-510k.jpg K173831 - Glidesheath Slender K173831 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corporation. Cleared May 2018. https://www.510kdatabase.net/k173901/ 2018-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k173901-myosure-manual-tissue-removal-device-fda-510k.jpg K173901 - MyoSure MANUAL Tissue Removal Device K173901 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Hologic, Inc.. Cleared May 2018. https://www.510kdatabase.net/k173912/ 2018-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k173912-bluperc-percutaneous-dilation-fda-510k.jpg K173912 - BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUperc Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect tube, BLUgriggs Percutaneous Dilation Tracheostomy Kit with BLUselect Suctionaid tube K173912 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Smiths Medical Asd, Inc.. Cleared May 2018. https://www.510kdatabase.net/k180386/ 2018-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k180386-meron-plus-qm-fda-510k.jpg K180386 - Meron Plus QM K180386 is a FDA 510(k) cleared dental medical device. Manufacturer: Voco GmbH. Cleared May 2018. https://www.510kdatabase.net/k180922/ 2018-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k180922-empower-h100-cyber-ho-100-litho-100-fda-510k.jpg K180922 - Empower H100, Cyber Ho 100, Litho 100 K180922 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Quanta System Spa. Cleared May 2018. https://www.510kdatabase.net/k180031/ 2018-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k180031-endopath-electrosurgery-probe-plus-ii-fda-510k.jpg K180031 - Endopath Electrosurgery Probe Plus II K180031 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon Endo-Surgery, LLC. Cleared May 2018. https://www.510kdatabase.net/k180034/ 2018-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k180034-weinmann-tracheostomy-exchange-set-fda-510k.jpg K180034 - Weinmann Tracheostomy Exchange Set K180034 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Cook Incorporated. Cleared May 2018. https://www.510kdatabase.net/k180079/ 2018-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k180079-hill-rom-vitals-monitoring-system-fda-510k.jpg K180079 - Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Packs (different #), Hill-Rom Vitals Monitoring System powered by EarlySense: Sensor Activation K180079 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Hill-Rom, Inc.. Cleared May 2018. https://www.510kdatabase.net/k180296/ 2018-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k180296-afinion-hba1c-dx-fda-510k.jpg K180296 - Afinion HbA1c Dx K180296 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Alere Technologies AS. Cleared May 2018. https://www.510kdatabase.net/den170015/ 2018-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/den170015-hemospray-endoscopic-hemostat-fda-510k.jpg DEN170015 - Hemospray Endoscopic Hemostat DEN170015 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wilson-Cook Medical, Inc.. Cleared May 2018. https://www.510kdatabase.net/k162021/ 2018-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k162021-30-dynamic-tibase-fda-510k.jpg K162021 - 3.0 Dynamic TiBase K162021 is a FDA 510(k) cleared dental medical device. Manufacturer: Talladium Espana, SL. Cleared May 2018. https://www.510kdatabase.net/k172100/ 2018-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k172100-uris-omni-system-fda-510k.jpg K172100 - URIS OMNI System K172100 is a FDA 510(k) cleared dental medical device. Manufacturer: Truabutment, Inc.. Cleared May 2018. https://www.510kdatabase.net/k172271/ 2018-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k172271-trackit-t4-eeg-amplifier-fda-510k.jpg K172271 - Trackit T4 EEG Amplifier K172271 is a FDA 510(k) cleared neurology medical device. Manufacturer: Lifelines , Ltd.. Cleared May 2018. https://www.510kdatabase.net/k172568/ 2018-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k172568-cervage-fda-510k.jpg K172568 - Cervage K172568 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Precifit Medical, Ltd.. Cleared May 2018. https://www.510kdatabase.net/k172614/ 2018-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k172614-caldera-medical-transobturator-helical-fda-510k.jpg K172614 - Caldera Medical Transobturator Helical Introducer, Left K172614 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Caldera Medical, Inc.. Cleared May 2018. https://www.510kdatabase.net/k173345/ 2018-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k173345-td-4140-smart-dongle-blood-glucose-fda-510k.jpg K173345 - TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring System K173345 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Taidoc Technology Corporation. Cleared May 2018. https://www.510kdatabase.net/k173684/ 2018-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k173684-gestim-pro-fda-510k.jpg K173684 - g.Estim PRO K173684 is a FDA 510(k) cleared neurology medical device. Manufacturer: G.Tec Medical Engineering GmbH. Cleared May 2018. https://www.510kdatabase.net/k173711/ 2018-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k173711-wallaby-avenir-coil-system-fda-510k.jpg K173711 - Wallaby Avenir Coil System K173711 is a FDA 510(k) cleared neurology medical device. Manufacturer: Wallaby Medical, Inc.. Cleared May 2018. https://www.510kdatabase.net/k173874/ 2018-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k173874-stitchkit-v-loc-90-stitchkit-v-loc-180-fda-510k.jpg K173874 - StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO K173874 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Origami Surgical, LLC. Cleared May 2018. https://www.510kdatabase.net/k173892/ 2018-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k173892-nuvasive-xlx-interbody-system-fda-510k.jpg K173892 - NuVasive® XLX Interbody System K173892 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared May 2018. https://www.510kdatabase.net/k173913/ 2018-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k173913-medrad-imaging-bulk-package-transfer-set-fda-510k.jpg K173913 - MEDRAD® Imaging Bulk Package Transfer Set K173913 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bayer U.S., LLC. Cleared May 2018. https://www.510kdatabase.net/k180157/ 2018-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k180157-qt-ecg-fda-510k.jpg K180157 - QT ECG K180157 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: QT Medical, Inc.. Cleared May 2018. https://www.510kdatabase.net/k180313/ 2018-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k180313-apollo-tms-therapy-system-fda-510k.jpg K180313 - Apollo TMS Therapy System K180313 is a FDA 510(k) cleared neurology medical device. Manufacturer: Mag & More GmbH. Cleared May 2018. https://www.510kdatabase.net/k180317/ 2018-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k180317-evolution-knee-systems-mr-labeling-fda-510k.jpg K180317 - EVOLUTION® Knee Systems – MR Labeling, EVOLUTION® BIOFOAM® Tibial System, EVOLUTION® Revision Tibial System, EVOLUTION® Revision CCK System K180317 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Microport Orthopedics, Inc.. Cleared May 2018. https://www.510kdatabase.net/k180437/ 2018-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k180437-hexanium-tlif-fda-510k.jpg K180437 - Hexanium® TLIF K180437 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinevision, S.A.S.. Cleared May 2018. https://www.510kdatabase.net/k180623/ 2018-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k180623-ulthera-system-fda-510k.jpg K180623 - Ulthera System K180623 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ulthera, Inc.. Cleared May 2018. https://www.510kdatabase.net/k180641/ 2018-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k180641-invenia-abus-viewer-fda-510k.jpg K180641 - Invenia ABUS Viewer K180641 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared May 2018. https://www.510kdatabase.net/k180740/ 2018-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k180740-vitriguard-fda-510k.jpg K180740 - VitriGuard K180740 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Origio A/S. Cleared May 2018. https://www.510kdatabase.net/k180891/ 2018-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k180891-evol-spinal-interbody-system-evos-fda-510k.jpg K180891 - EVOL Spinal Interbody System, EVOS Lumbar Interbody System K180891 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Cutting Edge Spine, LLC. Cleared May 2018. https://www.510kdatabase.net/k171007/ 2018-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k171007-fluorescence-mode-fda-510k.jpg K171007 - Fluorescence Mode K171007 is a FDA 510(k) cleared dental medical device. Manufacturer: Carl Zeiss Suzhou Co., Ltd.. Cleared May 2018. https://www.510kdatabase.net/k171577/ 2018-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k171577-smartcord-smartcord-x-fda-510k.jpg K171577 - Smartcord, Smartcord X K171577 is a FDA 510(k) cleared dental medical device. Manufacturer: Eastdent Co., Ltd.. Cleared May 2018. https://www.510kdatabase.net/k172137/ 2018-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k172137-piezotome-cube-fda-510k.jpg K172137 - PIEZOTOME CUBE K172137 is a FDA 510(k) cleared dental medical device. Manufacturer: Satelec - Acteon Group. Cleared May 2018. https://www.510kdatabase.net/k172777/ 2018-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k172777-catheter-clamping-adapter-luer-80369-7-fda-510k.jpg K172777 - Catheter Clamping Adapter LUER 80369-7, Catheter Clamping Adapter NRFit 80369-7 K172777 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: PAJUNK GmbH Medizintechnologie. Cleared May 2018. https://www.510kdatabase.net/k172980/ 2018-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k172980-micropuncture-pedal-access-set-fda-510k.jpg K172980 - Micropuncture Pedal Access Set K172980 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared May 2018. https://www.510kdatabase.net/k173540/ 2018-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k173540-brainsway-deep-dtms-system-fda-510k.jpg K173540 - Brainsway Deep (DTMS) System K173540 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainsway , Ltd.. Cleared May 2018. https://www.510kdatabase.net/k180019/ 2018-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k180019-caas-workstation-fda-510k.jpg K180019 - CAAS Workstation K180019 is a FDA 510(k) cleared radiology medical device. Manufacturer: Pie Medical Imaging BV. Cleared May 2018. https://www.510kdatabase.net/k180071/ 2018-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k180071-stylo-interbody-fusion-device-fda-510k.jpg K180071 - STYLO Interbody Fusion Device K180071 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Legend Spine Technologies. Cleared May 2018. https://www.510kdatabase.net/k180162/ 2018-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k180162-vivascope-system-fda-510k.jpg K180162 - VivaScope System K180162 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Caliber Imaging & Diagnostics, Inc.. Cleared May 2018. https://www.510kdatabase.net/k180214/ 2018-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k180214-repris-bladder-injection-system-fda-510k.jpg K180214 - Repris Bladder Injection System K180214 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Uro-1, Inc.. Cleared May 2018. https://www.510kdatabase.net/k180939/ 2018-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k180939-indigo-aspiration-system-modified-110-fda-510k.jpg K180939 - Indigo Aspiration System - Modified 110 Aspiration Tubing K180939 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Penumbra, Inc.. Cleared May 2018. https://www.510kdatabase.net/k181001/ 2018-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k181001-medtronic-confida-brecker-guidewire-fda-510k.jpg K181001 - Medtronic Confida Brecker Guidewire K181001 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Core Valve, LLC. Cleared May 2018. https://www.510kdatabase.net/k172409/ 2018-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k172409-lite-fda-510k.jpg K172409 - Lite K172409 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Tzora Active Systems , Ltd.. Cleared May 2018. https://www.510kdatabase.net/k172864/ 2018-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k172864-non-sterile-powder-free-blue-nitrile-fda-510k.jpg K172864 - Non-Sterile Powder Free Blue Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs K172864 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Maxter Glove Manufacturing Sdn Bhd. Cleared May 2018. https://www.510kdatabase.net/k173653/ 2018-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k173653-alere-i-strep-a-2-alere-i-instrument-fda-510k.jpg K173653 - Alere i Strep A 2, Alere i instrument, Alere i Strep A 2 Control Swab Kit K173653 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Alere Scarborough, Inc.. Cleared May 2018. https://www.510kdatabase.net/k173807/ 2018-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k173807-accu-o2-oxygen-analyzer-fda-510k.jpg K173807 - Accu O2 Oxygen Analyzer K173807 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Precision Medical, Inc.. Cleared May 2018. https://www.510kdatabase.net/k173825/ 2018-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k173825-mc-300r-nebulizer-fda-510k.jpg K173825 - MC 300R* Nebulizer K173825 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Trudell Medical International. Cleared May 2018. https://www.510kdatabase.net/k173861/ 2018-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k173861-drug-relief-fda-510k.jpg K173861 - Drug Relief K173861 is a FDA 510(k) cleared neurology medical device. Manufacturer: Dyansys, Inc.. Cleared May 2018. https://www.510kdatabase.net/k173946/ 2018-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k173946-adapt-for-gamma3-fda-510k.jpg K173946 - ADAPT for Gamma3 K173946 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker GmbH. Cleared May 2018. https://www.510kdatabase.net/k180028/ 2018-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k180028-cook-810-set-desilets-hoffman-fda-510k.jpg K180028 - Cook 810 Set, Desilets-Hoffman Introducer Set K180028 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared May 2018. https://www.510kdatabase.net/k180264/ 2018-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k180264-gold-standard-diagnostics-borrelia-fda-510k.jpg K180264 - Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit K180264 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Gold Standard Diagnostics. Cleared May 2018. https://www.510kdatabase.net/k180352/ 2018-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k180352-7d-surgical-system-fda-510k.jpg K180352 - 7D Surgical System K180352 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 7D Surgical, Inc.. Cleared May 2018. https://www.510kdatabase.net/k180599/ 2018-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k180599-venue-fda-510k.jpg K180599 - Venue K180599 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared May 2018. https://www.510kdatabase.net/k180796/ 2018-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k180796-spineology-navigation-instruments-fda-510k.jpg K180796 - Spineology Navigation Instruments K180796 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spineology, Inc.. Cleared May 2018. https://www.510kdatabase.net/k172412/ 2018-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k172412-bacterioscan-216dx-system-fda-510k.jpg K172412 - BacterioScan 216Dx System K172412 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bacterioscan, Inc.. Cleared May 2018. https://www.510kdatabase.net/k172554/ 2018-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k172554-luofucon-extra-silver-alginate-fda-510k.jpg K172554 - LUOFUCON Extra Silver Alginate Dressing, LUOFUCON Extra Antibacterial Alginate Dressing K172554 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Huizhou Foryou Medical Devices Co., Ltd.. Cleared May 2018. https://www.510kdatabase.net/k172555/ 2018-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k172555-sapphire-elevare-sapphire-fda-510k.jpg K172555 - SAPPHIRE, ELEVARE SAPPHIRE K172555 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Omm Imports, Inc. D/B/A Zero Gravity. Cleared May 2018. https://www.510kdatabase.net/k172656/ 2018-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k172656-bililux-fda-510k.jpg K172656 - BiliLux K172656 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Draeger Medical Systems, Inc.. Cleared May 2018. https://www.510kdatabase.net/k172959/ 2018-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k172959-peraserver-and-peratrend-fda-510k.jpg K172959 - PeraServer and PeraTrend K172959 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Perahealth, Inc.. Cleared May 2018. https://www.510kdatabase.net/k173035/ 2018-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k173035-gordon-large-bore-curved-drainage-fda-510k.jpg K173035 - Gordon Large-Bore Curved Drainage Catheter, Nephrostomy Pigtail Drainage Catheter, Percutaneous Nephrostomy Set, Pigtail Drainage Catheter Needle Set, Multipurpose Drainage Catheters and Sets K173035 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared May 2018. https://www.510kdatabase.net/k173300/ 2018-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k173300-viatherm-boost-fda-510k.jpg K173300 - ViaTherm BOOST K173300 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Viatherm Therapeutics, LLC. Cleared May 2018. https://www.510kdatabase.net/k173718/ 2018-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k173718-liberty-cycler-set-fda-510k.jpg K173718 - Liberty Cycler Set K173718 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC. Cleared May 2018. https://www.510kdatabase.net/k180848/ 2018-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k180848-ambient-super-multivac-50-wand-with-fda-510k.jpg K180848 - AMBIENT Super MULTIVAC 50 Wand with Integrated Finger Switches K180848 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: ArthroCare Corporation. Cleared May 2018. https://www.510kdatabase.net/k171678/ 2018-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k171678-gas-sampling-line-coextruded-2m7ft-fda-510k.jpg K171678 - Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 2.5m/8ft, 10/pkg, Disposable, Gas Sampling Line, Coextruded, 3m/10ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 6m/20ft, 5/pkg, Disposable K171678 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Vyaire Medical, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k172636/ 2018-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k172636-vitamesh-macroporous-pp-surgical-mesh-fda-510k.jpg K172636 - VitaMESH Macroporous PP Surgical Mesh K172636 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Proxy Biomedical , Ltd.. Cleared Apr 2018. https://www.510kdatabase.net/k172726/ 2018-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k172726-evis-exera-iii-bronchofibervideoscope-fda-510k.jpg K172726 - EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433D K172726 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Apr 2018. https://www.510kdatabase.net/k173304/ 2018-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k173304-finessis-intense-polyisoprene-surgical-fda-510k.jpg K173304 - Finessis Intense Polyisoprene Surgical Glove K173304 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Lucenxia Prescience AG. Cleared Apr 2018. https://www.510kdatabase.net/k180307/ 2018-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k180307-mazor-x-fda-510k.jpg K180307 - Mazor X K180307 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Mazor Robotics , Ltd.. Cleared Apr 2018. https://www.510kdatabase.net/k180636/ 2018-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k180636-exactvu-high-resolution-micro-fda-510k.jpg K180636 - ExactVu High Resolution Micro-Ultrasound System K180636 is a FDA 510(k) cleared radiology medical device. Manufacturer: Exact Imaging, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k180696/ 2018-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k180696-medline-green-ambidextrous-powder-free-fda-510k.jpg K180696 - Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal (Tested for use with Chemotherapy Drugs) K180696 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k171151/ 2018-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k171151-acron-tlif-system-fda-510k.jpg K171151 - ACRON™ TLIF System K171151 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinemed Ges.M.B.H. Cleared Apr 2018. https://www.510kdatabase.net/k172166/ 2018-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k172166-olympic-navigated-instruments-fda-510k.jpg K172166 - OLYMPIC Navigated Instruments K172166 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Astura Medical. Cleared Apr 2018. https://www.510kdatabase.net/k172258/ 2018-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k172258-novasight-hybrid-system-fda-510k.jpg K172258 - Novasight Hybrid System K172258 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Conavi Medical, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k172460/ 2018-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k172460-adhear-system-fda-510k.jpg K172460 - ADHEAR System K172460 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Med-El Elektromedizinische Geraete GmbH. Cleared Apr 2018. https://www.510kdatabase.net/k172720/ 2018-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k172720-tracoe-silcosoft-tracheostomy-tube-fda-510k.jpg K172720 - TRACOE silcosoft Tracheostomy Tube K172720 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Tracoe Medical GmbH. Cleared Apr 2018. https://www.510kdatabase.net/k172747/ 2018-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k172747-hyaluronic-acid-topical-wound-cream-fda-510k.jpg K172747 - HYALURONIC ACID TOPICAL WOUND CREAM K172747 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Virchow Biotech Pvt, Ltd.. Cleared Apr 2018. https://www.510kdatabase.net/k172764/ 2018-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k172764-keymill-fda-510k.jpg K172764 - Keymill K172764 is a FDA 510(k) cleared dental medical device. Manufacturer: Mycone Dental Supply Company, Inc. (Aka Keystone Industries). Cleared Apr 2018. https://www.510kdatabase.net/k172866/ 2018-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k172866-neurocap-fda-510k.jpg K172866 - NeuroCap K172866 is a FDA 510(k) cleared neurology medical device. Manufacturer: Memory MD, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k173390/ 2018-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k173390-hipeos-fda-510k.jpg K173390 - hipEOS K173390 is a FDA 510(k) cleared radiology medical device. Manufacturer: Onefit Medical. Cleared Apr 2018. https://www.510kdatabase.net/k180069/ 2018-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k180069-hdr-mri-lumen-marker-fda-510k.jpg K180069 - HDR MRI Lumen Marker K180069 is a FDA 510(k) cleared radiology medical device. Manufacturer: C4 Imaging, LLC. Cleared Apr 2018. https://www.510kdatabase.net/k180154/ 2018-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k180154-qif-blood-and-fluid-warmer-fda-510k.jpg K180154 - QiF Blood and Fluid Warmer K180154 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Quality IN Flow , Ltd.. Cleared Apr 2018. https://www.510kdatabase.net/k180669/ 2018-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k180669-focus-dailies-focus-dailies-toric-fda-510k.jpg K180669 - Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total 1 / DAILIES Total 1 Multifocal K180669 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Alcon Laboratories, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k170339/ 2018-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k170339-summit-hip-system-fda-510k.jpg K170339 - Summit Hip System K170339 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k171821/ 2018-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k171821-2-face-face-evolution-fda-510k.jpg K171821 - 2 Face / Face Evolution K171821 is a FDA 510(k) cleared neurology medical device. Manufacturer: Heat IN A Click. Cleared Apr 2018. https://www.510kdatabase.net/k171872/ 2018-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k171872-p50-series-dental-operative-unit-and-fda-510k.jpg K171872 - P50 Series Dental Operative Unit and Accessories K171872 is a FDA 510(k) cleared dental medical device. Manufacturer: Pelton & Crane. Cleared Apr 2018. https://www.510kdatabase.net/k172633/ 2018-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k172633-infinity-total-ankle-system-fda-510k.jpg K172633 - INFINITY Total Ankle System K172633 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Apr 2018. https://www.510kdatabase.net/k172875/ 2018-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k172875-astral-100150-fda-510k.jpg K172875 - Astral 100/150 K172875 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Resmed, Ltd.. Cleared Apr 2018. https://www.510kdatabase.net/k172923/ 2018-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k172923-nitrile-examination-powder-free-glove-fda-510k.jpg K172923 - Nitrile Examination Powder Free Glove, White, Black, Orange, Nitrile Examination Powder Free Gloves Tested For Use With Chemotherapy Drugs, Blue K172923 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Top Glove Sdn. Bhd.. Cleared Apr 2018. https://www.510kdatabase.net/k172955/ 2018-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k172955-lungvision-tool-fda-510k.jpg K172955 - LungVision Tool K172955 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Bodyvision Medical , Ltd.. Cleared Apr 2018. https://www.510kdatabase.net/k173201/ 2018-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k173201-unity-sacroiliac-joint-fixation-system-fda-510k.jpg K173201 - UNITY Sacroiliac Joint Fixation System K173201 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Huvexel Co. , Ltd.. Cleared Apr 2018. https://www.510kdatabase.net/k173337/ 2018-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k173337-intuitive-surgical-endowrist-vessel-fda-510k.jpg K173337 - Intuitive Surgical EndoWrist Vessel Sealer Extend K173337 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k173398/ 2018-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k173398-xpert-xpress-strep-a-fda-510k.jpg K173398 - Xpert Xpress Strep A K173398 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Cepheid. Cleared Apr 2018. https://www.510kdatabase.net/k180037/ 2018-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k180037-beacon-eus-access-system-fda-510k.jpg K180037 - Beacon EUS Access System K180037 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Covidien, LLC. Cleared Apr 2018. https://www.510kdatabase.net/k180200/ 2018-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k180200-esg-300-apu-300-pressure-reducer-mapc-fda-510k.jpg K180200 - ESG-300, APU-300, Pressure Reducer, MAPC Probes K180200 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Olympus Winter & Ibe GmbH. Cleared Apr 2018. https://www.510kdatabase.net/k180433/ 2018-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k180433-ennovate-fda-510k.jpg K180433 - ENNOVATE® K180433 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aesculap Implant Systems, LLC. Cleared Apr 2018. https://www.510kdatabase.net/k180548/ 2018-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k180548-3f-single-lumen-and-4f-dual-lumen-fda-510k.jpg K180548 - 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers K180548 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc (Bard Has Joined Bd). Cleared Apr 2018. https://www.510kdatabase.net/den170028/ 2018-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/den170028-cala-one-fda-510k.jpg DEN170028 - Cala ONE DEN170028 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cala Health, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k162525/ 2018-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k162525-oniko-nail-brace-fda-510k.jpg K162525 - Oniko nail brace K162525 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Begum Saglik Hizmetleri Tibbi Malzemeler Danismanlik Lsti. Cleared Apr 2018. https://www.510kdatabase.net/k173143/ 2018-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k173143-phasix-st-mesh-fda-510k.jpg K173143 - Phasix ST Mesh K173143 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k173321/ 2018-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k173321-stimuquik-21g-x-9cm-35-peripheral-fda-510k.jpg K173321 - StimuQuik 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik 21G x 2.5cm (1”) Peripheral Nerve Block Needle K173321 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Teleflex Medical. Cleared Apr 2018. https://www.510kdatabase.net/k173782/ 2018-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k173782-unid-patient-specific-3d-printed-cage-fda-510k.jpg K173782 - UNiD Patient Specific 3D printed cage K173782 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medicrea International SA. Cleared Apr 2018. https://www.510kdatabase.net/k180002/ 2018-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k180002-rampart-one-lumbar-interbody-fusion-fda-510k.jpg K180002 - Rampart One Lumbar Interbody Fusion Device K180002 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spineology, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k180257/ 2018-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k180257-incore-lapidus-system-fda-510k.jpg K180257 - InCore® Lapidus System K180257 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nextremity Solutions, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k180379/ 2018-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k180379-raystation-7-fda-510k.jpg K180379 - RayStation 7 K180379 is a FDA 510(k) cleared radiology medical device. Manufacturer: RaySearch Laboratories AB (PUBL). Cleared Apr 2018. https://www.510kdatabase.net/k180514/ 2018-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k180514-veriton-nm-fda-510k.jpg K180514 - VERITON NM K180514 is a FDA 510(k) cleared radiology medical device. Manufacturer: Spectrum Dynamics Medical, Ltd.. Cleared Apr 2018. https://www.510kdatabase.net/k180563/ 2018-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k180563-syngoplaza-fda-510k.jpg K180563 - syngo.plaza K180563 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Healthcare GmbH. Cleared Apr 2018. https://www.510kdatabase.net/k180616/ 2018-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k180616-optimum-gp-roflufocon-d-roflurocon-e-fda-510k.jpg K180616 - OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens K180616 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Contamac, Ltd.. Cleared Apr 2018. https://www.510kdatabase.net/k162314/ 2018-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k162314-imactis-ct-navigation-system-fda-510k.jpg K162314 - IMACTIS CT-Navigation system K162314 is a FDA 510(k) cleared radiology medical device. Manufacturer: Imactis, Sas. Cleared Apr 2018. https://www.510kdatabase.net/k172464/ 2018-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k172464-xd880a-ultrasonic-osteotomy-surgical-fda-510k.jpg K172464 - XD880A Ultrasonic Osteotomy Surgical System K172464 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Morley Research Consortium. Cleared Apr 2018. https://www.510kdatabase.net/k172768/ 2018-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k172768-zoom-fda-510k.jpg K172768 - ZOOM K172768 is a FDA 510(k) cleared radiology medical device. Manufacturer: Zetta Medical Technologies, LLC. Cleared Apr 2018. https://www.510kdatabase.net/k173865/ 2018-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k173865-trophon2-fda-510k.jpg K173865 - trophon2 K173865 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Nanosonics Limited. Cleared Apr 2018. https://www.510kdatabase.net/k180030/ 2018-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k180030-tyrx-absorbable-antibacterial-envelope-fda-510k.jpg K180030 - TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large) K180030 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medtronic, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k180206/ 2018-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k180206-neuromate-gen-iii-fda-510k.jpg K180206 - neuromate Gen III K180206 is a FDA 510(k) cleared neurology medical device. Manufacturer: Renishaw Mayfield Sarl. Cleared Apr 2018. https://www.510kdatabase.net/k180222/ 2018-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k180222-reaxon-plus-fda-510k.jpg K180222 - Reaxon Plus K180222 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medovent GmbH. Cleared Apr 2018. https://www.510kdatabase.net/k180225/ 2018-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k180225-gsi-viewer-with-gsi-fat-option-fda-510k.jpg K180225 - GSI Viewer with GSI Fat Option K180225 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems SCS. Cleared Apr 2018. https://www.510kdatabase.net/k180252/ 2018-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k180252-crown-dental-zirconia-blank-crown-fda-510k.jpg K180252 - Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank K180252 is a FDA 510(k) cleared dental medical device. Manufacturer: Crown Porcelain Dental Technology Co., Ltd.. Cleared Apr 2018. https://www.510kdatabase.net/k180277/ 2018-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k180277-smith-nephew-sureshot-distal-targeting-fda-510k.jpg K180277 - Smith & Nephew SURESHOT Distal Targeting System V4.0 Targeter K180277 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k171883/ 2018-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k171883-sysmex-uf-5000-fully-automated-urine-fda-510k.jpg K171883 - Sysmex UF-5000 Fully Automated Urine Particle Analyzer K171883 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sysmex America, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k171917/ 2018-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k171917-frova-intubating-introducer-fda-510k.jpg K171917 - Frova Intubating Introducer K171917 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Cook Incorporated. Cleared Apr 2018. https://www.510kdatabase.net/k172329/ 2018-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k172329-patient-status-engine-fda-510k.jpg K172329 - Patient Status Engine K172329 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Isansys Lifecare, Ltd.. Cleared Apr 2018. https://www.510kdatabase.net/k172393/ 2018-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k172393-advisor-hd-grid-mapping-catheter-fda-510k.jpg K172393 - Advisor HD Grid Mapping Catheter, Sensor Enabled K172393 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: St. Jude Medical, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k172396/ 2018-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k172396-ensite-velocity-cardiac-mapping-system-fda-510k.jpg K172396 - EnSite Velocity Cardiac Mapping System v5.2 K172396 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: St Jude Medical. Cleared Apr 2018. https://www.510kdatabase.net/k172699/ 2018-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k172699-agile-nail-fda-510k.jpg K172699 - Agile Nail K172699 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthofix Srl. Cleared Apr 2018. https://www.510kdatabase.net/k173519/ 2018-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k173519-3m-attest-super-rapid-readout-steam-fda-510k.jpg K173519 - 3M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super Rapid 5 Steam-Plus Chaallenge Pack, 3M Attest Auto-reader, 3M Attest Auto-reader K173519 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Apr 2018. https://www.510kdatabase.net/k173715/ 2018-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k173715-alertwatchob-fda-510k.jpg K173715 - AlertWatch:OB K173715 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Alertwatch, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k173842/ 2018-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k173842-da-vinci-xi-surgical-system-da-vinci-x-fda-510k.jpg K173842 - da Vinci Xi Surgical System, da Vinci X Surgical System K173842 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k180090/ 2018-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k180090-cure-lumbar-plate-system-fda-510k.jpg K180090 - Cure™ Lumbar Plate System K180090 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Meditech Spine, LLC. Cleared Apr 2018. https://www.510kdatabase.net/k180499/ 2018-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k180499-reprocessed-ligasure-maryland-jaw-fda-510k.jpg K180499 - Reprocessed LigaSure Maryland Jaw Sealer/Divider K180499 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker Sustainability Solutions. Cleared Apr 2018. https://www.510kdatabase.net/k171443/ 2018-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k171443-etherea-mx-fda-510k.jpg K171443 - Etherea MX K171443 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Vydence Medical Industria E Comercio Ltda. Cleared Apr 2018. https://www.510kdatabase.net/k172244/ 2018-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k172244-euroimmun-ifa-crithidia-luciliae-anti-fda-510k.jpg K172244 - EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern K172244 is a FDA 510(k) cleared immunology medical device. Manufacturer: Euroimmun Us, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k172252/ 2018-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k172252-euroimmun-ifa-crithidia-luciliae-fda-510k.jpg K172252 - EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern K172252 is a FDA 510(k) cleared immunology medical device. Manufacturer: Euroimmun Us, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k172511/ 2018-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k172511-hickman-trifusion-catheter-fda-510k.jpg K172511 - Hickman TriFusion Catheter K172511 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k173258/ 2018-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k173258-polychloroprene-powder-free-sterile-fda-510k.jpg K173258 - Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy K173258 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Pt. Medisafe Technologies. Cleared Apr 2018. https://www.510kdatabase.net/k173855/ 2018-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k173855-sharpsite-ac-rigid-endsocope-fda-510k.jpg K173855 - Sharpsite AC Rigid Endsocope K173855 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Medtronic Xomed, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k173900/ 2018-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k173900-arthrex-univers-revers-modular-glenoid-fda-510k.jpg K173900 - Arthrex Univers Revers Modular Glenoid System K173900 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k173902/ 2018-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k173902-neodent-implant-system-gm-line-fda-510k.jpg K173902 - Neodent Implant System – GM Line K173902 is a FDA 510(k) cleared dental medical device. Manufacturer: Jjgc Industria E Comercio DE Materiais Dentarios S.A.. Cleared Apr 2018. https://www.510kdatabase.net/k173962/ 2018-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k173962-viamo-c100-tus-vc100-diagnostic-fda-510k.jpg K173962 - Viamo c100 TUS-VC100 Diagnostic Ultrasound System K173962 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshibamedical Systems Corporation. Cleared Apr 2018. https://www.510kdatabase.net/k180140/ 2018-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k180140-proflex-laser-fibers-fda-510k.jpg K180140 - ProFlex Laser Fibers K180140 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Innovaquartz, LLC. Cleared Apr 2018. https://www.510kdatabase.net/k180161/ 2018-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k180161-viz-ctp-fda-510k.jpg K180161 - Viz CTP K180161 is a FDA 510(k) cleared radiology medical device. Manufacturer: Viz. Ai, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k180219/ 2018-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k180219-jo-h2o-flavored-personal-lubricants-fda-510k.jpg K180219 - JO H2O Flavored Personal Lubricants K180219 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: United Consortium. Cleared Apr 2018. https://www.510kdatabase.net/k180304/ 2018-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k180304-geri-embryo-incubator-and-geri-dish-fda-510k.jpg K180304 - Geri Embryo Incubator and Geri Dish K180304 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Genea Biomedx Pty, Ltd.. Cleared Apr 2018. https://www.510kdatabase.net/k180322/ 2018-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k180322-si-hy-olifilcon-b-color-silicone-fda-510k.jpg K180322 - Si-Hy (olifilcon B) color silicone hydrogel soft contact lens K180322 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Visco Vision, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k180451/ 2018-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k180451-reprocessed-ligasure-impact-without-fda-510k.jpg K180451 - Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider K180451 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker Sustainability Solutions. Cleared Apr 2018. https://www.510kdatabase.net/k180618/ 2018-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k180618-pico-single-use-negative-pressure-fda-510k.jpg K180618 - PICO Single Use Negative Pressure Wound Therapy System K180618 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew Medical Limited. Cleared Apr 2018. https://www.510kdatabase.net/k180750/ 2018-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k180750-world-knee-system-fda-510k.jpg K180750 - World Knee System K180750 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Signature Orthopaedics Pty, Ltd.. Cleared Apr 2018. https://www.510kdatabase.net/k180753/ 2018-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k180753-safetyfix-easyout-system-fda-510k.jpg K180753 - SafetyFix EasyOut System K180753 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Safetyfix Medical Technologies, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k180765/ 2018-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k180765-televere-podiatry-x-ray-system-hf-fda-510k.jpg K180765 - Televere Podiatry X-Ray System HF K180765 is a FDA 510(k) cleared radiology medical device. Manufacturer: Televere Systems, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k180782/ 2018-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k180782-aria-fda-510k.jpg K180782 - Aria K180782 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. Cleared Apr 2018. https://www.510kdatabase.net/den170010/ 2018-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/den170010-lzi-carisoprodol-metabolite-fda-510k.jpg DEN170010 - LZI Carisoprodol Metabolite (Meprobamate) Enzyme Immunoassay DEN170010 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Lin-Zhi International, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/den170081/ 2018-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/den170081-maldi-biotyper-ca-system-fda-510k.jpg DEN170081 - MALDI Biotyper CA System DEN170081 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bruker Daltonik GmbH. Cleared Apr 2018. https://www.510kdatabase.net/k171720/ 2018-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k171720-encevis-fda-510k.jpg K171720 - encevis K171720 is a FDA 510(k) cleared neurology medical device. Manufacturer: Ait Austrian Institute of Technology GmbH. Cleared Apr 2018. https://www.510kdatabase.net/k172154/ 2018-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k172154-isolette-8000-plus-fda-510k.jpg K172154 - Isolette 8000 plus K172154 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Draeger Medical Sytems, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k172167/ 2018-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k172167-zenith-flex-system-fda-510k.jpg K172167 - Zenith Flex System K172167 is a FDA 510(k) cleared neurology medical device. Manufacturer: Inneuroco, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k172306/ 2018-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k172306-superslyde-personal-lubricant-fda-510k.jpg K172306 - SuperSlyde Personal Lubricant K172306 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Icm Pharma Pte, Ltd.. Cleared Apr 2018. https://www.510kdatabase.net/k172365/ 2018-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k172365-panoramic-oxygen-mask-pom-fda-510k.jpg K172365 - Panoramic Oxygen Mask (POM) K172365 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Pom Medical, LLC. Cleared Apr 2018. https://www.510kdatabase.net/k172416/ 2018-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k172416-synermed-opiate-enzyme-immunoassay-fda-510k.jpg K172416 - Synermed Opiate Enzyme Immunoassay K172416 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Infrared Laboratory Systems, LLC (Dba Synermed). Cleared Apr 2018. https://www.510kdatabase.net/k172427/ 2018-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k172427-avita-radar-thermo-nt16-series-ir-fda-510k.jpg K172427 - AViTA Radar Thermo NT16 Series IR Thermometer K172427 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Avita Corporation. Cleared Apr 2018. https://www.510kdatabase.net/k172477/ 2018-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k172477-ischemaview-rapid-fda-510k.jpg K172477 - iSchemaView RAPID K172477 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ischemaview, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k172478/ 2018-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k172478-tens-device-emeterm-cinvstop-fda-510k.jpg K172478 - TENS device-EmeTerm, CinvStop K172478 is a FDA 510(k) cleared neurology medical device. Manufacturer: Wat Medical Technology (Ningbo) Co., Ltd.. Cleared Apr 2018. https://www.510kdatabase.net/k172588/ 2018-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k172588-balloon-catheter-and-balloon-ureteral-fda-510k.jpg K172588 - Balloon Catheter and Balloon Ureteral Dilator Set K172588 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Apr 2018. https://www.510kdatabase.net/k172598/ 2018-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k172598-coventry-topical-anesthetic-mist-spray-fda-510k.jpg K172598 - Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream Spray HAZMAT FREE K172598 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Itw Contamination Control Electronics. Cleared Apr 2018. https://www.510kdatabase.net/k172887/ 2018-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k172887-xinbo-electrode-model-neck-therapy-pro-fda-510k.jpg K172887 - XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV) K172887 is a FDA 510(k) cleared neurology medical device. Manufacturer: Guangzhou Xinbo Electronic Co., Ltd.. Cleared Apr 2018. https://www.510kdatabase.net/k172919/ 2018-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k172919-ev-804-otc-pain-relief-tens-fda-510k.jpg K172919 - EV-804 OTC Pain Relief TENS K172919 is a FDA 510(k) cleared neurology medical device. Manufacturer: Everyway Medical Instruments Co.,Ltd. Cleared Apr 2018. https://www.510kdatabase.net/k173472/ 2018-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k173472-myspine-pedicle-screw-placement-guides-fda-510k.jpg K173472 - MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments K173472 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Apr 2018. https://www.510kdatabase.net/k173757/ 2018-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k173757-vacuette-evoprotect-safety-blood-fda-510k.jpg K173757 - VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set K173757 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Greiner Bio-One Na, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k180007/ 2018-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k180007-018-hydrophilic-coated-otw-pta-balloon-fda-510k.jpg K180007 - 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter K180007 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Creagh Medical, Ltd.. Cleared Apr 2018. https://www.510kdatabase.net/k180102/ 2018-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k180102-embozene-color-advanced-microspheres-fda-510k.jpg K180102 - Embozene Color-Advanced Microspheres K180102 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific. Cleared Apr 2018. https://www.510kdatabase.net/k180336/ 2018-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k180336-syngomr-applications-fda-510k.jpg K180336 - syngo.MR Applications K180336 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k180576/ 2018-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k180576-solar-storm-solar-wave-sunco-and-esb-fda-510k.jpg K180576 - Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select) K180576 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lpi, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k180684/ 2018-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k180684-coaguchek-xs-plus-system-fda-510k.jpg K180684 - CoaguChek XS Plus System K180684 is a FDA 510(k) cleared hematology medical device. Manufacturer: Roche Diagnostics. Cleared Apr 2018. https://www.510kdatabase.net/k180693/ 2018-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k180693-coaguchek-xs-pro-system-fda-510k.jpg K180693 - CoaguChek XS Pro System K180693 is a FDA 510(k) cleared hematology medical device. Manufacturer: Roche Diagnostics. Cleared Apr 2018. https://www.510kdatabase.net/k180731/ 2018-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k180731-ultramatrix-eus-balloon-fda-510k.jpg K180731 - Ultramatrix EUS Balloon K180731 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: United States Endoscopy Group, Inc. (Us Endoscopy). Cleared Apr 2018. https://www.510kdatabase.net/k180873/ 2018-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k180873-medtronic-model-53401-external-pulse-fda-510k.jpg K180873 - Medtronic Model 53401 External Pulse Generator (EPG) K180873 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k172880/ 2018-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k172880-microlife-upper-arm-automatic-digital-fda-510k.jpg K172880 - Microlife Upper Arm Automatic Digital Blood Pressure Monitor K172880 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Microlife Intellectual Property GmbH. Cleared Apr 2018. https://www.510kdatabase.net/k172947/ 2018-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k172947-half-dome-posterior-lumbar-interbody-fda-510k.jpg K172947 - HALF DOME Posterior Lumbar Interbody System K172947 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Astura Medical. Cleared Apr 2018. https://www.510kdatabase.net/k173432/ 2018-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k173432-enza-a-titanium-alif-fda-510k.jpg K173432 - ENZA-A Titanium ALIF K173432 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Camber Spine Technologies. Cleared Apr 2018. https://www.510kdatabase.net/k173615/ 2018-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k173615-stryker-universal-select-sterilization-fda-510k.jpg K173615 - Stryker Universal Select Sterilization Tray System K173615 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Paragon Medical. Cleared Apr 2018. https://www.510kdatabase.net/k173661/ 2018-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k173661-wingman-35-crossing-catheter-fda-510k.jpg K173661 - Wingman 35 Crossing Catheter K173661 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Reflow Medical, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k173964/ 2018-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k173964-ovomotion-shoulder-arthroplasty-system-fda-510k.jpg K173964 - OVOMotion Shoulder Arthroplasty System K173964 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrosurface, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k180081/ 2018-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k180081-railway-sheathless-access-system-fda-510k.jpg K180081 - RAILWAY Sheathless Access System K180081 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corporation. Cleared Apr 2018. https://www.510kdatabase.net/k180836/ 2018-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k180836-genistrong-fda-510k.jpg K180836 - Genistrong K180836 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Genicon, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k180851/ 2018-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k180851-vertex-reconstruction-system-fda-510k.jpg K180851 - VERTEX™ Reconstruction System K180851 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k172288/ 2018-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k172288-fusion-omni-sphincterotome-fda-510k.jpg K172288 - Fusion OMNI Sphincterotome K172288 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Wilson-Cook Medical Inc./Cook Endoscopy. Cleared Apr 2018. https://www.510kdatabase.net/k172610/ 2018-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k172610-thunderbeat-5-mm-20-cm-front-actuated-fda-510k.jpg K172610 - THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S K172610 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Apr 2018. https://www.510kdatabase.net/k172735/ 2018-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k172735-wr19-system-fda-510k.jpg K172735 - WR19 System K172735 is a FDA 510(k) cleared neurology medical device. Manufacturer: Zeto, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k173317/ 2018-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k173317-dilumen-c2-fda-510k.jpg K173317 - DiLumen C2 K173317 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Lumendi, LLC. Cleared Apr 2018. https://www.510kdatabase.net/k173614/ 2018-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k173614-penumbra-coil-400-ruby-coil-system-pod-fda-510k.jpg K173614 - Penumbra Coil 400, Ruby Coil System, POD System K173614 is a FDA 510(k) cleared neurology medical device. Manufacturer: Penumbra, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k173816/ 2018-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k173816-nmct-850-nmct-860-fda-510k.jpg K173816 - NM/CT 850, NM/CT 860 K173816 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Apr 2018. https://www.510kdatabase.net/k180078/ 2018-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k180078-px-peek-ibf-system-px-ha-peek-ibf-fda-510k.jpg K180078 - Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System K180078 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Innovasis, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k180146/ 2018-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k180146-karl-storz-icg-imaging-system-fda-510k.jpg K180146 - KARL STORZ ICG Imaging System K180146 is a FDA 510(k) cleared neurology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k180353/ 2018-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k180353-diode-laser-hair-removal-device-fda-510k.jpg K180353 - Diode laser hair removal device K180353 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Zhengzhou PZ Laser Slim Technology Co., Ltd.. Cleared Apr 2018. https://www.510kdatabase.net/k180416/ 2018-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k180416-viperwire-advance-guide-wire-stealth-fda-510k.jpg K180416 - ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System K180416 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cardiovascular Systems, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k180458/ 2018-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k180458-focus-pedicle-screw-system-fda-510k.jpg K180458 - FOCUS Pedicle Screw System K180458 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nvision Biomedical Technologies, LLC. Cleared Apr 2018. https://www.510kdatabase.net/k180588/ 2018-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k180588-fast1-intraosseous-infusion-system-fda-510k.jpg K180588 - FAST1™ Intraosseous Infusion System K180588 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Teleflex Medical. Cleared Apr 2018. https://www.510kdatabase.net/k180723/ 2018-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k180723-preludesync-distal-radial-compression-fda-510k.jpg K180723 - PreludeSYNC DISTAL Radial Compression System K180723 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k180914/ 2018-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k180914-aesculap-slim-clip-applier-fda-510k.jpg K180914 - Aesculap Slim Clip Applier K180914 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k171603/ 2018-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k171603-cope-nephroureterostomy-stent-and-fda-510k.jpg K171603 - Cope Nephroureterostomy Stent and Amplatz Ureteral Stent Set K171603 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Apr 2018. https://www.510kdatabase.net/k172727/ 2018-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k172727-hemoclip-fda-510k.jpg K172727 - Hemoclip K172727 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hangzhou AGS MedTech Co., Ltd.. Cleared Apr 2018. https://www.510kdatabase.net/k173226/ 2018-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k173226-cardimax-electrocardiograph-fda-510k.jpg K173226 - CardiMax Electrocardiograph K173226 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Fukuda Denshi USA, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k173726/ 2018-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k173726-immunocap-specific-ige-immunocap-fda-510k.jpg K173726 - ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut K173726 is a FDA 510(k) cleared immunology medical device. Manufacturer: Phadia AB. Cleared Apr 2018. https://www.510kdatabase.net/k173935/ 2018-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k173935-mediant-anterior-cervical-plating-system-fda-510k.jpg K173935 - Mediant Anterior Cervical Plating System K173935 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Intelligent Implant Systems, LLC. Cleared Apr 2018. https://www.510kdatabase.net/k180096/ 2018-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k180096-gdt-1000-system-fda-510k.jpg K180096 - GDT-1000 System K180096 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Acuvu, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k180126/ 2018-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k180126-sozo-fda-510k.jpg K180126 - SOZO K180126 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: ImpediMed Limited. Cleared Apr 2018. https://www.510kdatabase.net/k162499/ 2018-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k162499-best-instruminal-applicator-fda-510k.jpg K162499 - Best Instruminal Applicator K162499 is a FDA 510(k) cleared radiology medical device. Manufacturer: Best Medical International, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k170463/ 2018-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k170463-ketosens-blood-b-ketone-monitoring-fda-510k.jpg K170463 - KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System K170463 is a FDA 510(k) cleared chemistry medical device. Manufacturer: I-Sens, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k170761/ 2018-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k170761-lightsonic-bubm-fda-510k.jpg K170761 - LIGHTSonic BUBM K170761 is a FDA 510(k) cleared radiology medical device. Manufacturer: Lightmed USA, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k170901/ 2018-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k170901-albumin-alkaline-phosphatase-alp-amp-fda-510k.jpg K170901 - ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400 K170901 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Biosystems S.A.. Cleared Apr 2018. https://www.510kdatabase.net/k171326/ 2018-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k171326-piezosurgery-white-fda-510k.jpg K171326 - Piezosurgery White K171326 is a FDA 510(k) cleared dental medical device. Manufacturer: Mectron S.P.A.. Cleared Apr 2018. https://www.510kdatabase.net/k171562/ 2018-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k171562-dynax-clear-dynax-putty-dynax-heavy-fda-510k.jpg K171562 - Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono K171562 is a FDA 510(k) cleared dental medical device. Manufacturer: Dreve Dentamid GmbH. Cleared Apr 2018. https://www.510kdatabase.net/k172143/ 2018-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k172143-umi-780-petct-system-fda-510k.jpg K172143 - uMI 780 PET/CT System K172143 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Apr 2018. https://www.510kdatabase.net/k172930/ 2018-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k172930-mcare-powder-free-blue-nitrile-fda-510k.jpg K172930 - mCare Powder-free Blue Nitrile Examination Gloves K172930 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Mercator Medical (Thailand), Ltd.. Cleared Apr 2018. https://www.510kdatabase.net/k173103/ 2018-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k173103-pivet-and-soft-pass-embryo-transfer-fda-510k.jpg K173103 - Pivet and Soft-Pass Embryo Transfer Catheter Sets K173103 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Cook Incorporated. Cleared Apr 2018. https://www.510kdatabase.net/k173371/ 2018-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k173371-visumax-femtosecond-laser-fda-510k.jpg K173371 - VisuMax Femtosecond Laser K173371 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Carl Zeiss Meditec, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k173606/ 2018-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k173606-seaspine-vu-apod-prime-nanometalene-fda-510k.jpg K173606 - SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu a•POD Prime Intervertebral Body Fusion Device K173606 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared Apr 2018. https://www.510kdatabase.net/k173632/ 2018-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k173632-somatom-goup-somatom-gonow-somatom-fda-510k.jpg K173632 - SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GO K173632 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k173692/ 2018-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k173692-d-actor-200-vibration-massage-system-fda-510k.jpg K173692 - D-Actor 200 Vibration Massage System K173692 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Storz Medical AG. Cleared Apr 2018. https://www.510kdatabase.net/k173934/ 2018-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k173934-reza-band-reflux-band-fda-510k.jpg K173934 - Reza Band, Reflux Band K173934 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Somna Therapeutics, LLC. Cleared Apr 2018. https://www.510kdatabase.net/k180305/ 2018-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k180305-hychloderm-wound-and-skin-care-rx-and-fda-510k.jpg K180305 - Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC) K180305 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aquilabs Us, LLC. Cleared Apr 2018. https://www.510kdatabase.net/k180408/ 2018-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k180408-u60-diagnostic-ultrasound-system-fda-510k.jpg K180408 - U60 Diagnostic Ultrasound System K180408 is a FDA 510(k) cleared radiology medical device. Manufacturer: Edan Instruments, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k180667/ 2018-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k180667-smartgrid-fda-510k.jpg K180667 - SmartGrid K180667 is a FDA 510(k) cleared radiology medical device. Manufacturer: Carestream Health, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k180699/ 2018-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k180699-voyant-open-fusion-device-fda-510k.jpg K180699 - Voyant Open Fusion Device K180699 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Applied Medical Resources Corporation. Cleared Apr 2018. https://www.510kdatabase.net/k180704/ 2018-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k180704-sonosite-iviz-ultrasound-system-fda-510k.jpg K180704 - SonoSite iViz Ultrasound System K180704 is a FDA 510(k) cleared radiology medical device. Manufacturer: FUJIFILM Sonosite, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k172155/ 2018-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k172155-statguard-hemostatic-patch-statguard-fda-510k.jpg K172155 - StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing K172155 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Statguard, LLC. Cleared Apr 2018. https://www.510kdatabase.net/k172201/ 2018-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k172201-atellica-im-folate-assay-fda-510k.jpg K172201 - Atellica IM Folate Assay K172201 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k172315/ 2018-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k172315-straub-endovascular-system-fda-510k.jpg K172315 - Straub Endovascular System K172315 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Straub Medical AG. Cleared Apr 2018. https://www.510kdatabase.net/k173515/ 2018-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k173515-admiral-xtreme-fda-510k.jpg K173515 - Admiral Xtreme K173515 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Apr 2018. https://www.510kdatabase.net/k180549/ 2018-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k180549-zed-link-fda-510k.jpg K180549 - ZED Link K180549 is a FDA 510(k) cleared radiology medical device. Manufacturer: Zed Technologies. Cleared Apr 2018. https://www.510kdatabase.net/k180567/ 2018-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k180567-c3-wave-system-fda-510k.jpg K180567 - C3 Wave System K180567 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medical Components, Inc. (dba MedComp). Cleared Apr 2018. https://www.510kdatabase.net/k180651/ 2018-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k180651-uroview-fd-ii-fda-510k.jpg K180651 - Uroview FD II K180651 is a FDA 510(k) cleared radiology medical device. Manufacturer: Pausch Medical GmbH. Cleared Apr 2018. https://www.510kdatabase.net/k180666/ 2018-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k180666-48ch-head-coil-fda-510k.jpg K180666 - 48CH Head Coil K180666 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare Coils (Usa Instruments, Inc.). Cleared Apr 2018. https://www.510kdatabase.net/k180689/ 2018-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k180689-padlock-clip-defect-closure-device-fda-510k.jpg K180689 - Padlock Clip defect closure device K180689 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: STERIS Corporation. Cleared Apr 2018. https://www.510kdatabase.net/k180795/ 2018-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k180795-judo-1-guidewire-judo-3-guidewire-judo-fda-510k.jpg K180795 - JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire K180795 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific. Cleared Apr 2018. https://www.510kdatabase.net/k172047/ 2018-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k172047-riva-star-fda-510k.jpg K172047 - Riva Star K172047 is a FDA 510(k) cleared dental medical device. Manufacturer: Sdi Limited. Cleared Apr 2018. https://www.510kdatabase.net/k172187/ 2018-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k172187-inno-hydrowire-fda-510k.jpg K172187 - Inno-Hydrowire K172187 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Suzhou Innomed Medical Device Co., Ltd.. Cleared Apr 2018. https://www.510kdatabase.net/k172495/ 2018-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k172495-reform-poct-system-fda-510k.jpg K172495 - Reform® POCT System K172495 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Precision Spine, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k173686/ 2018-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k173686-guardia-access-embryo-transfer-fda-510k.jpg K173686 - Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter K173686 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Cook Incorporated. Cleared Apr 2018. https://www.510kdatabase.net/k173859/ 2018-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k173859-healix-advance-anchor-with-dynacord-fda-510k.jpg K173859 - HEALIX ADVANCE Anchor with DYNACORD Suture K173859 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International SARL. Cleared Apr 2018. https://www.510kdatabase.net/k173860/ 2018-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k173860-s5-intravascular-ultrasound-imaging-fda-510k.jpg K173860 - s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound Imaging and Pressure Systems, CORE Precision Guided Therapy System, CORE Mobile Precision Guided Therapy System K173860 is a FDA 510(k) cleared radiology medical device. Manufacturer: Volcano Corporation. Cleared Apr 2018. https://www.510kdatabase.net/k173880/ 2018-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k173880-corin-trifit-cf-hip-stem-fda-510k.jpg K173880 - Corin TriFit CF Hip Stem K173880 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corin U.S.A. Limited. Cleared Apr 2018. https://www.510kdatabase.net/k180121/ 2018-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k180121-rafugen-dbm-fda-510k.jpg K180121 - Rafugen DBM K180121 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Cellumed Co., Ltd.. Cleared Apr 2018. https://www.510kdatabase.net/k180318/ 2018-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k180318-pet-digital-gating-fda-510k.jpg K180318 - PET Digital Gating K180318 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems, LLC. Cleared Apr 2018. https://www.510kdatabase.net/k180744/ 2018-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k180744-stablyx-cmc-arthroplasty-implant-system-fda-510k.jpg K180744 - Stablyx CMC Arthroplasty Implant System K180744 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Skeletal Dynamics, LLC. Cleared Apr 2018. https://www.510kdatabase.net/den180001/ 2018-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/den180001-idx-dr-fda-510k.jpg DEN180001 - IDx-DR DEN180001 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Idx, LLC. Cleared Apr 2018. https://www.510kdatabase.net/k170776/ 2018-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k170776-dti-1-sla-implant-system-fda-510k.jpg K170776 - DTI-1 SLA IMPLANT SYSTEM K170776 is a FDA 510(k) cleared dental medical device. Manufacturer: Dti Implant Sistemleri Sanayi Ticaret Anonim Sirketi. Cleared Apr 2018. https://www.510kdatabase.net/k171379/ 2018-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k171379-digital-automatic-wrist-blood-pressure-fda-510k.jpg K171379 - Digital Automatic Wrist Blood Pressure Monitor MD4300 K171379 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Grandway Technology (Shenzhen) Limited. Cleared Apr 2018. https://www.510kdatabase.net/k172206/ 2018-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k172206-naja-ligament-correction-system-fda-510k.jpg K172206 - NAJA™ Ligament Correction System K172206 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Cousin Biotech Sas. Cleared Apr 2018. https://www.510kdatabase.net/k172967/ 2018-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k172967-mercury-spinal-system-fda-510k.jpg K172967 - Mercury® Spinal System K172967 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spinal Elements, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k173384/ 2018-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k173384-bluselect-non-fenestrated-bluselect-fda-510k.jpg K173384 - BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube K173384 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Smiths Medical Ads, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k180233/ 2018-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k180233-eviva-stereotactic-guided-breast-fda-510k.jpg K180233 - Eviva Stereotactic Guided Breast Biopsy System K180233 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hologic, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k180299/ 2018-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k180299-acuvue-oasys-senofilcon-a-with-fda-510k.jpg K180299 - ACUVUE OASYS (senofilcon A) with Photochromic Additive K180299 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Johnson & Johnson Vision Care, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k180301/ 2018-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k180301-axis-55-lumbar-pedicle-screw-system-fda-510k.jpg K180301 - AXIS 5.5 Lumbar Pedicle Screw System K180301 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Axis Orthopaedics. Cleared Apr 2018. https://www.510kdatabase.net/k180398/ 2018-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k180398-focus-dailies-focus-dailies-toric-fda-510k.jpg K180398 - Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total1, DAILIES Total1 Multifocal K180398 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Alcon Laboratories, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k180530/ 2018-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k180530-imager-ii-urology-torque-catheter-fda-510k.jpg K180530 - Imager II Urology Torque Catheter K180530 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Apr 2018. https://www.510kdatabase.net/den170001/ 2018-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/den170001-precision-flow-hvni-fda-510k.jpg DEN170001 - Precision Flow® HVNI DEN170001 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Vapotherm, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k171409/ 2018-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k171409-ot-equator-fda-510k.jpg K171409 - OT EQUATOR K171409 is a FDA 510(k) cleared dental medical device. Manufacturer: Rhein 83 Srl. Cleared Apr 2018. https://www.510kdatabase.net/k172151/ 2018-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k172151-hysteroscopy-system-fda-510k.jpg K172151 - Hysteroscopy System K172151 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Chongquin Jinshan Science & Technology (Group) Co., Ltd.. Cleared Apr 2018. https://www.510kdatabase.net/k173386/ 2018-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k173386-finessis-zero-flexylon-powder-free-fda-510k.jpg K173386 - Finessis Zero Flexylon Powder Free Sterile White Surgical Glove Tested for use with Chemotherapy Drugs K173386 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Lucenxia Prescience AG. Cleared Apr 2018. https://www.510kdatabase.net/k173889/ 2018-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k173889-medline-cautery-electrode-ptfe-fda-510k.jpg K173889 - Medline Cautery Electrode (PTFE) K173889 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medline Industries, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k180083/ 2018-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k180083-silicone-personal-lubricant-all-in-one-fda-510k.jpg K180083 - Silicone Personal Lubricant, ALL-IN-ONE K180083 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: United Consortium. Cleared Apr 2018. https://www.510kdatabase.net/k180208/ 2018-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k180208-disposable-endoscopic-trocar-fda-510k.jpg K180208 - Disposable Endoscopic Trocar K180208 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Fengh Medical Co., Ltd.. Cleared Apr 2018. https://www.510kdatabase.net/k180329/ 2018-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k180329-clottriever-thrombectomy-system-fda-510k.jpg K180329 - ClotTriever Thrombectomy System K180329 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inari Medical, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k180372/ 2018-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k180372-aurora-evacuator-fda-510k.jpg K180372 - Aurora Evacuator K180372 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Rebound Therapeutics. Cleared Apr 2018. https://www.510kdatabase.net/k170570/ 2018-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k170570-anchored-beaconr-transponder-anchored-fda-510k.jpg K170570 - Anchored Beacon(R) transponder, Anchored transponder, Beacon Care Package - Lung K170570 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k172173/ 2018-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k172173-diaspect-tm-diaspect-tm-cuvettes-fda-510k.jpg K172173 - DiaSpect Tm, DiaSpect Tm Cuvettes K172173 is a FDA 510(k) cleared hematology medical device. Manufacturer: Ekf Diagnostic GmbH. Cleared Apr 2018. https://www.510kdatabase.net/k172956/ 2018-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k172956-medicant-mucosal-atomizer-fda-510k.jpg K172956 - Medicant Mucosal Atomizer K172956 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Medica Holdings, LLC. Cleared Apr 2018. https://www.510kdatabase.net/k173525/ 2018-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k173525-novogro-fda-510k.jpg K173525 - NovoGro K173525 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonovus, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k173767/ 2018-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k173767-a-l-p-s-clavicle-plating-system-fda-510k.jpg K173767 - A. L. P. S. Clavicle Plating System K173767 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k173775/ 2018-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k173775-clench-compression-staple-fda-510k.jpg K173775 - Clench Compression Staple K173775 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: F & A Foundation, LLC D.B.A. Reign Medical. Cleared Apr 2018. https://www.510kdatabase.net/k180033/ 2018-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k180033-8mm-monopolar-curved-scissors-fda-510k.jpg K180033 - 8mm Monopolar Curved Scissors K180033 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k180080/ 2018-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k180080-fibergraft-bg-matrix-bone-graft-fda-510k.jpg K180080 - FIBERGRAFT BG Matrix Bone Graft Substitute K180080 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Prosidyan, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k180271/ 2018-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k180271-navio-surgical-system-navio-system-fda-510k.jpg K180271 - NAVIO™ Surgical System (NAVIO system) K180271 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Blue Belt Technologies, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k180324/ 2018-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k180324-patriot-spinal-fixation-system-fda-510k.jpg K180324 - Patriot Spinal Fixation System K180324 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Valorus Spine. Cleared Apr 2018. https://www.510kdatabase.net/k180584/ 2018-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k180584-viveve-rf-system-secure-fda-510k.jpg K180584 - Viveve RF System, Secure K180584 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Viveve, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k180614/ 2018-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k180614-pico-single-use-negative-pressure-fda-510k.jpg K180614 - PICO Single Use Negative Pressure Wound Therapy System K180614 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew Medical Limited. Cleared Apr 2018. https://www.510kdatabase.net/k180630/ 2018-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k180630-ptfe-surgical-suture-fda-510k.jpg K180630 - PTFE SURGICAL SUTURE K180630 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Omnia Spa. Cleared Apr 2018. https://www.510kdatabase.net/k162408/ 2018-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k162408-nano-varnish-plaquit-lightpaint-on-fda-510k.jpg K162408 - Nano Varnish, Plaquit, Lightpaint on Surface K162408 is a FDA 510(k) cleared dental medical device. Manufacturer: Dreve Dentamid GmbH. Cleared Apr 2018. https://www.510kdatabase.net/k171713/ 2018-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k171713-neodent-instrument-kits-fda-510k.jpg K171713 - Neodent Instrument Kits K171713 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jjgc Industria E Comercio DE Materiais Dentarios S.A.. Cleared Apr 2018. https://www.510kdatabase.net/k171847/ 2018-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k171847-corin-optimized-positioning-system-ops-fda-510k.jpg K171847 - Corin Optimized Positioning System (OPS™) Plan K171847 is a FDA 510(k) cleared radiology medical device. Manufacturer: Corin U.S.A. Limited. Cleared Apr 2018. https://www.510kdatabase.net/k172014/ 2018-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k172014-wedge-microcatheter-fda-510k.jpg K172014 - Wedge Microcatheter K172014 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: MicroVention, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k172156/ 2018-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k172156-pentax-medical-epk-3000-video-imaging-fda-510k.jpg K172156 - PENTAX Medical EPK-3000 Video Imaging System K172156 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Pentax Medical. Cleared Apr 2018. https://www.510kdatabase.net/k172368/ 2018-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k172368-bipolar-micro-coagulation-forceps-fda-510k.jpg K172368 - Bipolar Micro-Coagulation Forceps K172368 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Gunter Bissinger Medizintechnik GmbH. Cleared Apr 2018. https://www.510kdatabase.net/k172998/ 2018-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k172998-uws-mi-fda-510k.jpg K172998 - uWS-MI K172998 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Apr 2018. https://www.510kdatabase.net/k173207/ 2018-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k173207-sic-invent-dental-implant-systems-fda-510k.jpg K173207 - SIC invent Dental Implant Systems K173207 is a FDA 510(k) cleared dental medical device. Manufacturer: Sic Invent AG. Cleared Apr 2018. https://www.510kdatabase.net/k173333/ 2018-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k173333-gore-enform-biomaterial-fda-510k.jpg K173333 - GORE ENFORM Biomaterial K173333 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k173526/ 2018-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k173526-sentio-mmg-gen-2-fda-510k.jpg K173526 - SENTIO MMG Gen 2 K173526 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medos International SARL. Cleared Apr 2018. https://www.510kdatabase.net/k173586/ 2018-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k173586-vamp-venousarterial-blood-management-fda-510k.jpg K173586 - VAMP Venous/Arterial Blood Management Protection System K173586 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Apr 2018. https://www.510kdatabase.net/k173867/ 2018-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k173867-axis-anterior-cervical-plate-system-fda-510k.jpg K173867 - Axis Anterior Cervical Plate System K173867 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Axis Orthopaedics. Cleared Apr 2018. https://www.510kdatabase.net/k173897/ 2018-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k173897-syngovia-mi-workflows-fda-510k.jpg K173897 - syngo.via MI Workflows K173897 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k180089/ 2018-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k180089-medacta-shoulder-system-short-humeral-fda-510k.jpg K180089 - Medacta Shoulder System Short Humeral Diaphysis K180089 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Apr 2018. https://www.510kdatabase.net/k180125/ 2018-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k180125-powerlook-density-assessment-software-fda-510k.jpg K180125 - PowerLook Density Assessment Software K180125 is a FDA 510(k) cleared radiology medical device. Manufacturer: Icad, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k180344/ 2018-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k180344-theracal-dc-fda-510k.jpg K180344 - TheraCal DC K180344 is a FDA 510(k) cleared dental medical device. Manufacturer: Bisco, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k180349/ 2018-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k180349-assuretech-panel-dip-tests-assuretech-fda-510k.jpg K180349 - AssureTech Panel Dip Tests, AssureTech Quick Cup Tests K180349 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Assure Tech. (Hangzhou) Co, Ltd.. Cleared Apr 2018. https://www.510kdatabase.net/k180376/ 2018-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k180376-k2m-patient-specific-rods-fda-510k.jpg K180376 - K2M Patient Specific Rods K180376 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: K2m, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k180378/ 2018-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k180378-optomed-aurora-camera-with-aurora-fda-510k.jpg K180378 - Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module K180378 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Optomed OY. Cleared Apr 2018. https://www.510kdatabase.net/k180589/ 2018-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k180589-dr-800-with-musica-dynamic-fda-510k.jpg K180589 - DR 800 with MUSICA Dynamic K180589 is a FDA 510(k) cleared radiology medical device. Manufacturer: Agfa Healthcare N.V.. Cleared Apr 2018. https://www.510kdatabase.net/k180694/ 2018-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k180694-turbo-power-20mm-laser-atherectomy-fda-510k.jpg K180694 - Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters K180694 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Spectranetics, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k172141/ 2018-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k172141-pulse-oximeter-fda-510k.jpg K172141 - Pulse Oximeter K172141 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shanghai Berry Electronic Tech Co., Ltd.. Cleared Apr 2018. https://www.510kdatabase.net/k172239/ 2018-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k172239-simplant-18-fda-510k.jpg K172239 - SIMPLANT 18 K172239 is a FDA 510(k) cleared radiology medical device. Manufacturer: Dentsply Sirona. Cleared Apr 2018. https://www.510kdatabase.net/k172963/ 2018-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k172963-master-frank-n95-particulate-respirator-fda-510k.jpg K172963 - Master-Frank N95 Particulate Respirator K172963 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Master & Frank Enterprise Co., Ltd.. Cleared Apr 2018. https://www.510kdatabase.net/k173072/ 2018-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k173072-algidex-ag-silver-alginate-wound-fda-510k.jpg K173072 - Algidex Ag Silver Alginate Wound Dressing K173072 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Deroyal Industries, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k173074/ 2018-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k173074-iconix-xbraid-tt-with-needles-nanotack-fda-510k.jpg K173074 - ICONIX XBraid TT with Needles, NanoTack TT Suture Anchor K173074 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker. Cleared Apr 2018. https://www.510kdatabase.net/k173079/ 2018-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k173079-ingenia-15t-ingenia-1-5t-s-ingenia-15t-fda-510k.jpg K173079 - Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4 K173079 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Apr 2018. https://www.510kdatabase.net/k173597/ 2018-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k173597-scenium-ve20-software-fda-510k.jpg K173597 - Scenium VE20 Software K173597 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k173699/ 2018-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k173699-the-pump-by-babyation-fda-510k.jpg K173699 - The Pump by Babyation K173699 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Babyation, LLC. Cleared Apr 2018. https://www.510kdatabase.net/k180088/ 2018-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k180088-trapliner-catheter-fda-510k.jpg K180088 - TrapLiner catheter K180088 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vascular Solutions, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k180339/ 2018-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k180339-liofilchem-mic-test-strip-mts-fda-510k.jpg K180339 - Liofilchem MIC Test Strip (MTS), Azithromycin 0.016 - 256 µg/mL K180339 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Liofilchem S. R. L.. Cleared Apr 2018. https://www.510kdatabase.net/k180342/ 2018-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k180342-system-1e-liquid-chemical-sterilant-fda-510k.jpg K180342 - SYSTEM 1E Liquid Chemical Sterilant Processing System K180342 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Steris Corporations. Cleared Apr 2018. https://www.510kdatabase.net/k180561/ 2018-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k180561-mobilex-portable-x-ray-system-fda-510k.jpg K180561 - MobileX Portable X-ray System K180561 is a FDA 510(k) cleared radiology medical device. Manufacturer: Denterprise International, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k180571/ 2018-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k180571-gammapod-fda-510k.jpg K180571 - GammaPod K180571 is a FDA 510(k) cleared radiology medical device. Manufacturer: Xcision Medical Systems, LLC. Cleared Apr 2018. https://www.510kdatabase.net/k180595/ 2018-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k180595-scimoca-fda-510k.jpg K180595 - SciMoCa K180595 is a FDA 510(k) cleared radiology medical device. Manufacturer: Radialogica, LLC. Cleared Apr 2018. https://www.510kdatabase.net/k180637/ 2018-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k180637-leva-pelvic-floor-trainer-fda-510k.jpg K180637 - leva Pelvic Floor Trainer K180637 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Renovia, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k172630/ 2018-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k172630-kisses-plus-implant-system-fda-510k.jpg K172630 - Kisses Plus Implant System K172630 is a FDA 510(k) cleared dental medical device. Manufacturer: Achimhai Medical Corporation. Cleared Apr 2018. https://www.510kdatabase.net/k172635/ 2018-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k172635-high-flo-silver-polyethylene-catheter-fda-510k.jpg K172635 - High-Flo Silver Polyethylene Catheter K172635 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Apr 2018. https://www.510kdatabase.net/k173362/ 2018-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k173362-dsm-biomedical-calcium-phosphate-cement-fda-510k.jpg K173362 - DSM Biomedical Calcium Phosphate Cement K173362 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Kensey Nash Corporation Dba Dsm Biomedical. Cleared Apr 2018. https://www.510kdatabase.net/k173506/ 2018-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k173506-ligapass-fda-510k.jpg K173506 - LigaPASS K173506 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medicrea International SA. Cleared Apr 2018. https://www.510kdatabase.net/k173885/ 2018-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k173885-genesys-spine-binary-lumbar-plate-system-fda-510k.jpg K173885 - Genesys Spine Binary Lumbar Plate System K173885 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Genesys Spine. Cleared Apr 2018. https://www.510kdatabase.net/k173958/ 2018-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k173958-oxyaqua-olifilcon-d-spherical-silicone-fda-510k.jpg K173958 - OxyAqua (olifilcon D) spherical silicone hydrogel soft contact lens, OxyAqua (olifilcon D) multifocal silicone hydrogel soft contact lens, OxyAqua (olifilcon D) toric silicone hydrogel soft contact lens K173958 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Visco Vision, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k180243/ 2018-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k180243-infinity-lock-button-system-fda-510k.jpg K180243 - Infinity-Lock Button System K180243 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Xiros, Ltd.. Cleared Apr 2018. https://www.510kdatabase.net/k180320/ 2018-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k180320-dpl-iia-panel-fda-510k.jpg K180320 - dpl IIa Panel K180320 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Led Technologies, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k180503/ 2018-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k180503-precice-stryde-system-fda-510k.jpg K180503 - PRECICE STRYDE System K180503 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nuvasive Specialized Orthopedics, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k180566/ 2018-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k180566-unite-connect-for-clinical-systems-fda-510k.jpg K180566 - Unite Connect for Clinical Systems K180566 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ascom (Sweden) AB. Cleared Apr 2018. https://www.510kdatabase.net/k180597/ 2018-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k180597-acupulse-previously-called-acupulse-fda-510k.jpg K180597 - AcuPulse (previously called AcuPulse 30/40 ST) K180597 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lumenis, Ltd.. Cleared Apr 2018. https://www.510kdatabase.net/k180677/ 2018-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k180677-surefire-spark-infusion-system-fda-510k.jpg K180677 - Surefire Spark Infusion System K180677 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Surefire Medical, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/den170047/ 2018-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/den170047-curetis-unyvero-lrt-application-fda-510k.jpg DEN170047 - Curetis Unyvero LRT Application DEN170047 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Curetis GmbH. Cleared Apr 2018. https://www.510kdatabase.net/k171692/ 2018-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k171692-instrument-basket-for-endoeye-fda-510k.jpg K171692 - Instrument basket, for EndoEYE K171692 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Olympus Winter & Ibe GmbH. Cleared Apr 2018. https://www.510kdatabase.net/k172382/ 2018-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k172382-gc-fuji-direct-fda-510k.jpg K172382 - GC Fuji Direct K172382 is a FDA 510(k) cleared dental medical device. Manufacturer: GC America, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k173639/ 2018-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k173639-luminos-drf-max-luminos-agile-max-fda-510k.jpg K173639 - Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax K173639 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medi Cal Solutions, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k173669/ 2018-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k173669-k-d-balance-fda-510k.jpg K173669 - K-D Balance K173669 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: King-Devick Technologies, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k173896/ 2018-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k173896-microcyn-antimicrobial-hydrogel-fda-510k.jpg K173896 - Microcyn Antimicrobial Hydrogel K173896 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sonoma Pharmaceuticals, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k180210/ 2018-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k180210-creo-stabilization-system-fda-510k.jpg K180210 - CREO® Stabilization System K180210 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k180586/ 2018-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k180586-varian-head-frame-fda-510k.jpg K180586 - Varian Head Frame K180586 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Apr 2018. https://www.510kdatabase.net/k170608/ 2018-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k170608-ufii-implant-system-fda-510k.jpg K170608 - UF(II) Implant System K170608 is a FDA 510(k) cleared dental medical device. Manufacturer: Dio Corporation. Cleared Mar 2018. https://www.510kdatabase.net/k171857/ 2018-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k171857-amsure-enteral-feeding-syringe-with-fda-510k.jpg K171857 - AMSure® Enteral Feeding Syringe with ENFit Tip K171857 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Amsino International, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k171867/ 2018-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k171867-drs-finder-neo-fda-510k.jpg K171867 - Dr’s Finder NEO K171867 is a FDA 510(k) cleared dental medical device. Manufacturer: Good Doctors Co., Ltd.. Cleared Mar 2018. https://www.510kdatabase.net/k171952/ 2018-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k171952-dimesol-tubing-sets-for-hemodialysis-fda-510k.jpg K171952 - Dimesol Tubing Sets for Hemodialysis K171952 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Dimesol, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k171988/ 2018-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k171988-performer-guiding-sheath-fda-510k.jpg K171988 - Performer Guiding Sheath K171988 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Mar 2018. https://www.510kdatabase.net/k171997/ 2018-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k171997-mandril-wire-guide-fda-510k.jpg K171997 - Mandril Wire Guide K171997 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Mar 2018. https://www.510kdatabase.net/k172078/ 2018-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k172078-immulisa-enhanced-rna-pol-iii-antibody-fda-510k.jpg K172078 - ImmuLisa Enhanced RNA POL III Antibody ELISA K172078 is a FDA 510(k) cleared immunology medical device. Manufacturer: Immco Diagnostics, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k172246/ 2018-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k172246-olympus-urf-v2v2r-fda-510k.jpg K172246 - OLYMPUS URF-V2/V2R K172246 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Mar 2018. https://www.510kdatabase.net/k172312/ 2018-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k172312-eego-amplifiers-fda-510k.jpg K172312 - eego amplifiers K172312 is a FDA 510(k) cleared neurology medical device. Manufacturer: Eemagine Medical Imaging Solutions GmbH. Cleared Mar 2018. https://www.510kdatabase.net/k172335/ 2018-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k172335-bleep-dreamport-fda-510k.jpg K172335 - Bleep DreamPort K172335 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Snapcpap. Cleared Mar 2018. https://www.510kdatabase.net/k173029/ 2018-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k173029-nipro-syringe-fda-510k.jpg K173029 - Nipro Syringe K173029 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Nipro Medical Corporation. Cleared Mar 2018. https://www.510kdatabase.net/k173379/ 2018-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k173379-straumann-variobase-for-crown-as-fda-510k.jpg K173379 - Straumann Variobase for Crown AS K173379 is a FDA 510(k) cleared dental medical device. Manufacturer: Institut Straumann AG. Cleared Mar 2018. https://www.510kdatabase.net/k173517/ 2018-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k173517-radspeed-fit-fda-510k.jpg K173517 - RADspeed fit K173517 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shimadzu Corporation. Cleared Mar 2018. https://www.510kdatabase.net/k173548/ 2018-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k173548-merit-pursue-microcatheter-fda-510k.jpg K173548 - Merit Pursue Microcatheter K173548 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k173617/ 2018-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k173617-magnetom-vida-with-compressed-sensing-fda-510k.jpg K173617 - MAGNETOM Vida with Compressed Sensing GRASP-VIBE K173617 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k173630/ 2018-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k173630-somatom-force-somatom-definition-flash-fda-510k.jpg K173630 - SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Deinition AS/AS+, SOMATOM Confidence K173630 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k173637/ 2018-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k173637-syngoct-coronary-analysis-fda-510k.jpg K173637 - syngo.CT Coronary Analysis K173637 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k173789/ 2018-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k173789-leksell-gamma-knife-perfexion-leksell-fda-510k.jpg K173789 - Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon K173789 is a FDA 510(k) cleared radiology medical device. Manufacturer: Elekta Instrument AB. Cleared Mar 2018. https://www.510kdatabase.net/k180194/ 2018-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k180194-sherpapak-cardiac-transport-system-and-fda-510k.jpg K180194 - SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System K180194 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Paragonix Technologies, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k180323/ 2018-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k180323-vitrea-software-package-fda-510k.jpg K180323 - Vitrea Software Package K180323 is a FDA 510(k) cleared radiology medical device. Manufacturer: Canon Medical Systems Corporation. Cleared Mar 2018. https://www.510kdatabase.net/k180538/ 2018-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k180538-gammacore-sapphire-fda-510k.jpg K180538 - gammaCore Sapphire K180538 is a FDA 510(k) cleared neurology medical device. Manufacturer: Electrocore, LLC. Cleared Mar 2018. https://www.510kdatabase.net/k180592/ 2018-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k180592-g-scan-brio-fda-510k.jpg K180592 - G-scan Brio K180592 is a FDA 510(k) cleared radiology medical device. Manufacturer: Esaote, S.P.A.. Cleared Mar 2018. https://www.510kdatabase.net/k171624/ 2018-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k171624-ixos-radius-plate-system-fda-510k.jpg K171624 - IXOS Radius Plate System K171624 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stuckenbrock Medizintechnik GmbH. Cleared Mar 2018. https://www.510kdatabase.net/k171841/ 2018-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k171841-arthrex-shoulder-system-fda-510k.jpg K171841 - Arthrex Shoulder System K171841 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k172071/ 2018-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k172071-terumo-capiox-nx19-oxygenator-with-fda-510k.jpg K172071 - Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo Capiox NX19 Oxygenator with Reservoir (west orientation ), Terumo Capiox NX19 Oxygenator (east orientation ), Terumo Capiox NX19 Oxygenator (west orientation) K172071 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Cardiovascular Systems Corporation. Cleared Mar 2018. https://www.510kdatabase.net/k172298/ 2018-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k172298-olympus-urf-p6p6r-fda-510k.jpg K172298 - OLYMPUS URF-P6/P6R K172298 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Mar 2018. https://www.510kdatabase.net/k172322/ 2018-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k172322-atellica-im-total-hcg-thcg-fda-510k.jpg K172322 - Atellica IM Total hCG (ThCG) K172322 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k172843/ 2018-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k172843-twitchview-system-fda-510k.jpg K172843 - TwitchView System K172843 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Blink Device Corporation. Cleared Mar 2018. https://www.510kdatabase.net/k173057/ 2018-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k173057-zimmer-knee-joint-replacement-fda-510k.jpg K173057 - Zimmer Knee Joint Replacement Prostheses MR Labeling K173057 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k173082/ 2018-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k173082-arco-sa-lumbar-cage-system-fda-510k.jpg K173082 - Arco™-SA Lumbar Cage System K173082 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Neurostructures, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k173439/ 2018-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k173439-bloom2-programmable-electrophysiology-fda-510k.jpg K173439 - Bloom2 Programmable Electrophysiology Stimulator K173439 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Fischer Medical. Cleared Mar 2018. https://www.510kdatabase.net/k173533/ 2018-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k173533-duette-100-silicone-dual-balloon-fda-510k.jpg K173533 - Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter K173533 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Poiesis Medical, LLC. Cleared Mar 2018. https://www.510kdatabase.net/k173799/ 2018-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k173799-navicross-0018-fda-510k.jpg K173799 - NaviCross 0.018 K173799 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Corporation. Cleared Mar 2018. https://www.510kdatabase.net/k180517/ 2018-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k180517-corpath-grx-system-fda-510k.jpg K180517 - CorPath GRX System K180517 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Corindus, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k180531/ 2018-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k180531-novostitch-pro-meniscal-repair-system-fda-510k.jpg K180531 - NovoStitch Pro Meniscal Repair System K180531 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ceterix Orthopaedics, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k180535/ 2018-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k180535-voluson-p6-and-voluson-p8-fda-510k.jpg K180535 - Voluson P6 and Voluson P8 K180535 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Mar 2018. https://www.510kdatabase.net/k171969/ 2018-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k171969-web-ii-memory-extraction-basket-or-fda-510k.jpg K171969 - Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5 Fr. Soft Wire Baskets or Memory Helical Stone Extractor, Memory Eight Wire Baskets or Memory Hard Wire Baskets, Fusion Wire Guided Extraction Basket, Non-Lithotripsy Extraction Basket K171969 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Wilson-Cook Medical, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k172235/ 2018-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k172235-corehip-system-fda-510k.jpg K172235 - CoreHip® System K172235 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aesculap Implants Systems, LLC. Cleared Mar 2018. https://www.510kdatabase.net/k172444/ 2018-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k172444-rosa-brain-v3005-fda-510k.jpg K172444 - ROSA BRAIN (v3.0.0.5) K172444 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtech S.A. Cleared Mar 2018. https://www.510kdatabase.net/k172627/ 2018-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k172627-david-home-pregnancy-test-cassette-fda-510k.jpg K172627 - David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette K172627 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Runbio Biotech Co.,Ltd. Cleared Mar 2018. https://www.510kdatabase.net/k173465/ 2018-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k173465-concentrix-mx-ac-high-speed-handpiece-fda-510k.jpg K173465 - Concentrix MX-AC High-Speed Handpiece K173465 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentalez, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k173489/ 2018-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k173489-gyn-pump-ph304-fda-510k.jpg K173489 - GYN-Pump PH304 K173489 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: W.O.M. World of Medicine GmbH. Cleared Mar 2018. https://www.510kdatabase.net/k173591/ 2018-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k173591-quantum-diagnostic-module-quantum-fda-510k.jpg K173591 - Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas K173591 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Spectrum Medical , Ltd.. Cleared Mar 2018. https://www.510kdatabase.net/k173727/ 2018-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k173727-ambu-ascope-3-slim-3812-and-ambu-fda-510k.jpg K173727 - Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2 K173727 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Ambu A/S. Cleared Mar 2018. https://www.510kdatabase.net/k180056/ 2018-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k180056-genesys-spine-ais-c-cervical-anchored-fda-510k.jpg K180056 - Genesys Spine AIS-C Cervical Anchored Interbody System K180056 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Genesys Spine. Cleared Mar 2018. https://www.510kdatabase.net/k180504/ 2018-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k180504-mission-lipid-panel-monitoring-system-fda-510k.jpg K180504 - Mission Lipid Panel Monitoring System K180504 is a FDA 510(k) cleared chemistry medical device. Manufacturer: ACON Laboratories, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k180558/ 2018-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k180558-pressurewire-x-fda-510k.jpg K180558 - PressureWire X K180558 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: St. Jude Medical (Now Part of Abbott Medical). Cleared Mar 2018. https://www.510kdatabase.net/k170605/ 2018-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k170605-upper-arm-type-electronic-blood-fda-510k.jpg K170605 - Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D K170605 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Jiangsu Yuyue Medical Equipment& Supply Co., Ltd.. Cleared Mar 2018. https://www.510kdatabase.net/k171241/ 2018-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k171241-pulse-oximeter-fda-510k.jpg K171241 - Pulse Oximeter K171241 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Hunan Accurate Bio-Medical Technology Co., Ltd.. Cleared Mar 2018. https://www.510kdatabase.net/k171966/ 2018-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k171966-mpact-3d-metal-implants-and-augments-fda-510k.jpg K171966 - Mpact® 3D Metal™ Implants and Augments 3D Metal™ K171966 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Mar 2018. https://www.510kdatabase.net/k172269/ 2018-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k172269-fortress-radiopaque-bone-cement-fda-510k.jpg K172269 - FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw System, REVLOK® Fenestrated Screw System K172269 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k173214/ 2018-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k173214-nes-reprocessed-rf-stylet-rfs-fda-510k.jpg K173214 - NES Reprocessed RF Stylet (RFS) K173214 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Northeast Scientific, Inc. (Nes). Cleared Mar 2018. https://www.510kdatabase.net/k173660/ 2018-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k173660-lensx-laser-system-fda-510k.jpg K173660 - LenSx Laser System K173660 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Alcon Laboratories, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k180063/ 2018-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k180063-ocm-g1-attachment-fda-510k.jpg K180063 - OCM-G1 Attachment K180063 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: The Anspach Effort, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k180114/ 2018-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k180114-aeon-retrieval-bag-fda-510k.jpg K180114 - AEON Retrieval Bag K180114 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lexington Medical, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k180308/ 2018-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k180308-prelude-fda-510k.jpg K180308 - Prelude K180308 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medcom GmbH. Cleared Mar 2018. https://www.510kdatabase.net/k180319/ 2018-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k180319-bausch-lomb-boston-advance-cleaner-fda-510k.jpg K180319 - Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution K180319 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Bausch and Lomb, Incorporated. Cleared Mar 2018. https://www.510kdatabase.net/k180537/ 2018-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k180537-zavation-buttress-plate-system-fda-510k.jpg K180537 - Zavation Buttress Plate System K180537 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zavation Medical Products, LLC. Cleared Mar 2018. https://www.510kdatabase.net/den170088/ 2018-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/den170088-dexcom-g6-continuous-glucose-fda-510k.jpg DEN170088 - Dexcom G6 Continuous Glucose Monitoring System DEN170088 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dexcom, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k172017/ 2018-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k172017-black-silicone-filiform-double-pigtail-fda-510k.jpg K172017 - Black Silicone Filiform Double Pigtail Stent Set K172017 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Mar 2018. https://www.510kdatabase.net/k172354/ 2018-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k172354-ossbuilder-system-fda-510k.jpg K172354 - OssBuilder System K172354 is a FDA 510(k) cleared dental medical device. Manufacturer: Osstem Implant Co., Ltd.. Cleared Mar 2018. https://www.510kdatabase.net/k172760/ 2018-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k172760-rest-eazy-appliance-fda-510k.jpg K172760 - REST EAZY Appliance K172760 is a FDA 510(k) cleared dental medical device. Manufacturer: Insert Molding Solutions, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k173310/ 2018-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k173310-smarttouch-fda-510k.jpg K173310 - SmartTouch K173310 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Adherium (Nz), Ltd.. Cleared Mar 2018. https://www.510kdatabase.net/k173922/ 2018-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k173922-c-ptfetm-surgical-suture-fda-510k.jpg K173922 - C-PTFETM Surgical Suture K173922 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cp Medical, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k180149/ 2018-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k180149-sonicision-reusable-generator-fda-510k.jpg K180149 - Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple lengths), Sonicision Battery Charger, Sonicision Battery Insertion Guide K180149 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien, LLC. Cleared Mar 2018. https://www.510kdatabase.net/k180315/ 2018-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k180315-diskom-fda-510k.jpg K180315 - DISKOM K180315 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biopsybell S.R.L.. Cleared Mar 2018. https://www.510kdatabase.net/den170023/ 2018-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/den170023-thermoneuromodulation-device-tnm-device-fda-510k.jpg DEN170023 - ThermoNeuroModulation Device, TNM Device DEN170023 is a FDA 510(k) cleared neurology medical device. Manufacturer: Scion Neurostim, LLC. Cleared Mar 2018. https://www.510kdatabase.net/k172035/ 2018-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k172035-ekos-ultrasound-evd-device-evd-control-fda-510k.jpg K172035 - EKOS ultrasound EVD Device, EVD Control Unit K172035 is a FDA 510(k) cleared neurology medical device. Manufacturer: Btg International, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k170410/ 2018-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k170410-longeviti-pmma-static-cranial-implant-fda-510k.jpg K170410 - Longeviti PMMA Static Cranial Implant K170410 is a FDA 510(k) cleared neurology medical device. Manufacturer: Longeviti Neuro Solutions, LLC. Cleared Mar 2018. https://www.510kdatabase.net/k170753/ 2018-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k170753-acculoc-total-knee-system-fda-510k.jpg K170753 - Acculoc Total Knee System K170753 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Rootloc Co., Ltd.. Cleared Mar 2018. https://www.510kdatabase.net/k172461/ 2018-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k172461-aeskuslides-anca-ethanol-aeskuslides-fda-510k.jpg K172461 - AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin K172461 is a FDA 510(k) cleared immunology medical device. Manufacturer: Aesku.Diagnostics GmbH & Co. KG. Cleared Mar 2018. https://www.510kdatabase.net/k172496/ 2018-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k172496-supercath-5-26g-fda-510k.jpg K172496 - SUPERCATH 5 (26G) K172496 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Togo Medikit Co., Ltd.. Cleared Mar 2018. https://www.510kdatabase.net/k172648/ 2018-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k172648-drive-devilbiss-igo-2-portable-oxygen-fda-510k.jpg K172648 - Drive DeVilbiss iGo 2 Portable Oxygen Concentrator K172648 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Devilbiss Healthcare, LLC. Cleared Mar 2018. https://www.510kdatabase.net/k172723/ 2018-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k172723-dario-lc-blood-glucose-monitoring-system-fda-510k.jpg K172723 - Dario LC Blood Glucose Monitoring System K172723 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Labstyle Innovation, Ltd.. Cleared Mar 2018. https://www.510kdatabase.net/k173241/ 2018-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k173241-med-tab-fda-510k.jpg K173241 - MED-TAB K173241 is a FDA 510(k) cleared radiology medical device. Manufacturer: Plum Medical Solutions GmbH. Cleared Mar 2018. https://www.510kdatabase.net/k173425/ 2018-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k173425-srt-100-fda-510k.jpg K173425 - SRT-100+ K173425 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sensus Healthcare, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k173886/ 2018-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k173886-cprmeter-2-cpr-feedback-device-fda-510k.jpg K173886 - CPRmeter 2 CPR Feedback Device K173886 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Laerdal Medical AS. Cleared Mar 2018. https://www.510kdatabase.net/k180052/ 2018-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k180052-uriswab-urine-collection-transport-and-fda-510k.jpg K180052 - UriSwab-Urine Collection, Transport and Preservation System K180052 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Copan Italia Spa. Cleared Mar 2018. https://www.510kdatabase.net/k180473/ 2018-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k180473-anyview-dr-series-fpd-fluoroscopic-fda-510k.jpg K180473 - ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-arm ANYVIEW-240DR, ANYVIEW-320DR, ANYVIEW-500DR K180473 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ecotron Co., Ltd.. Cleared Mar 2018. https://www.510kdatabase.net/k172371/ 2018-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k172371-arthrex-univers-revers-coated-baseplate-fda-510k.jpg K172371 - Arthrex UNIVERS REVERS COATED BASEPLATE K172371 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k173105/ 2018-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k173105-endoscopic-cap-check-flo-adapter-side-fda-510k.jpg K173105 - Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter K173105 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Mar 2018. https://www.510kdatabase.net/k173128/ 2018-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k173128-alamo-c-fda-510k.jpg K173128 - Alamo® C K173128 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alliance Partners, LLC. Cleared Mar 2018. https://www.510kdatabase.net/k173134/ 2018-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k173134-sentio-mmg-pedicle-access-needles-fda-510k.jpg K173134 - SENTIO MMG Pedicle Access Needles K173134 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medos International SARL. Cleared Mar 2018. https://www.510kdatabase.net/k173760/ 2018-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k173760-monarch-endoscopy-platform-monarch-fda-510k.jpg K173760 - Monarch Endoscopy Platform (Monarch Platform) K173760 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Auris Surgical Robotics, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k173903/ 2018-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k173903-granada-medium-fda-510k.jpg K173903 - Granada Medium K173903 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Hardy Diagnostics. Cleared Mar 2018. https://www.510kdatabase.net/k173915/ 2018-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k173915-test-of-variables-of-attention-tova-fda-510k.jpg K173915 - Test of Variables of Attention (T.O.V.A.) K173915 is a FDA 510(k) cleared neurology medical device. Manufacturer: The Tova Company. Cleared Mar 2018. https://www.510kdatabase.net/k180074/ 2018-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k180074-diazyme-lipoprotein-a-assay-fda-510k.jpg K180074 - Diazyme Lipoprotein (a) Assay K180074 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diazyme Laboratories, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k180431/ 2018-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k180431-cortina-max-lumbar-cage-system-fda-510k.jpg K180431 - Cortina [MAX] Lumbar Cage System K180431 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Neurostructures, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k180443/ 2018-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k180443-tumark-vision-fda-510k.jpg K180443 - Tumark Vision K180443 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Somatex Medical Technologies GmbH. Cleared Mar 2018. https://www.510kdatabase.net/k180453/ 2018-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k180453-bio-medicus-adult-cannulae-and-fda-510k.jpg K180453 - Bio-Medicus Adult Cannulae and Introducer K180453 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k180456/ 2018-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k180456-bio-medicus-adult-cannulae-kit-fda-510k.jpg K180456 - Bio-Medicus Adult Cannulae Kit K180456 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k180486/ 2018-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k180486-hemosil-factor-xii-deficient-plasma-fda-510k.jpg K180486 - HemosIL Factor XII Deficient Plasma K180486 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Mar 2018. https://www.510kdatabase.net/k163661/ 2018-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k163661-p-140-flex-coil-na-140-flex-coil-c-140-fda-510k.jpg K163661 - P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil K163661 is a FDA 510(k) cleared radiology medical device. Manufacturer: Rapid Biomedical GmbH. Cleared Mar 2018. https://www.510kdatabase.net/k171973/ 2018-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k171973-captura-disposable-hot-biopsy-forceps-fda-510k.jpg K171973 - Captura® Disposable Hot Biopsy Forceps K171973 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Wilson-Cook Medical, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k171982/ 2018-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k171982-droplet-pen-needle-fda-510k.jpg K171982 - DROPLET PEN NEEDLE K171982 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Htl-Strefa S.A. Cleared Mar 2018. https://www.510kdatabase.net/k172168/ 2018-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k172168-willceph-fda-510k.jpg K172168 - WillCeph K172168 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hdx Will Corp.. Cleared Mar 2018. https://www.510kdatabase.net/k172611/ 2018-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k172611-universal-cylinder-applicator-family-fda-510k.jpg K172611 - Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Sets, odd lengths and even lengths, Universal Titanium Cervix Probe Sets, odd lengths and even lengths K172611 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k173408/ 2018-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k173408-mammomat-revelation-fda-510k.jpg K173408 - Mammomat Revelation K173408 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medi Cal Solutions, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k173571/ 2018-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k173571-element-system-with-ibt-electrodes-fda-510k.jpg K173571 - Element System with IBT Electrodes K173571 is a FDA 510(k) cleared neurology medical device. Manufacturer: Infinite Biomedical Technologies, LLC. Cleared Mar 2018. https://www.510kdatabase.net/k173607/ 2018-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k173607-somatom-edge-plus-fda-510k.jpg K173607 - SOMATOM Edge Plus K173607 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k173619/ 2018-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k173619-mimics-inprint-fda-510k.jpg K173619 - Mimics inPrint K173619 is a FDA 510(k) cleared radiology medical device. Manufacturer: Materialise NV. Cleared Mar 2018. https://www.510kdatabase.net/k173846/ 2018-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k173846-dermascalp-laser-cap-fda-510k.jpg K173846 - DermaScalp Laser Cap K173846 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Dermascalp, LLC. Cleared Mar 2018. https://www.510kdatabase.net/k173887/ 2018-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k173887-cobas-ctng-for-use-on-cobas-68008800-fda-510k.jpg K173887 - cobas CT/NG for use on cobas 6800/8800 systems K173887 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Molecular Systems, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k180023/ 2018-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k180023-wirion-fda-510k.jpg K180023 - WIRION K180023 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Gardia Medical , Ltd.. Cleared Mar 2018. https://www.510kdatabase.net/k180148/ 2018-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k180148-ats-thermal-imaging-probe-ats-patient-fda-510k.jpg K180148 - ATS Thermal Imaging Probe, ATS Patient Interface Unit K180148 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Securus Medical Group, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k180192/ 2018-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k180192-emprint-ablation-visualization-fda-510k.jpg K180192 - Emprint Ablation Visualization Application K180192 is a FDA 510(k) cleared radiology medical device. Manufacturer: Covidien, LLC. Cleared Mar 2018. https://www.510kdatabase.net/k180211/ 2018-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k180211-freezpoint-fda-510k.jpg K180211 - Freezpoint K180211 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bovie Medical Corp.. Cleared Mar 2018. https://www.510kdatabase.net/k180274/ 2018-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k180274-ventix-link-knotless-anchor-with-fda-510k.jpg K180274 - Ventix Link Knotless Anchor with Inserter K180274 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Cayenne Medical, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k170957/ 2018-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k170957-reconnex-pre-sutured-tendon-fda-510k.jpg K170957 - ReConnex Pre-Sutured Tendon K170957 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Allosource. Cleared Mar 2018. https://www.510kdatabase.net/k171989/ 2018-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k171989-classic-ercp-catheter-and-huibregtse-fda-510k.jpg K171989 - Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon Angled, Glo-Tip ERCP Catheter, Glo-Tip II Double Lumen ERCP Catheter & w/ Radiopaque Bands, Fusion ERCP Catheter with DomeTip and Fusion OMNI ERCP Catheter with DomeTip, Haber RAMP Catheter, Soehendra Universal Catheter K171989 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Wilson-Cook Medical, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k172762/ 2018-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k172762-single-use-hemoclip-fda-510k.jpg K172762 - Single Use Hemoclip K172762 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Zhejiang Chuangxiang Medical Technology Co., Ltd.. Cleared Mar 2018. https://www.510kdatabase.net/k173451/ 2018-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k173451-ingenia-elition-s-and-ingenia-elition-x-fda-510k.jpg K173451 - Ingenia Elition S and Ingenia Elition X K173451 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Mar 2018. https://www.510kdatabase.net/k173919/ 2018-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k173919-hx-device-fda-510k.jpg K173919 - HX Device K173919 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Human Extension , Ltd.. Cleared Mar 2018. https://www.510kdatabase.net/k180015/ 2018-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k180015-philips-incisive-ct-fda-510k.jpg K180015 - Philips Incisive CT K180015 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Healthcare (Suzhou) Co., Ltd.. Cleared Mar 2018. https://www.510kdatabase.net/k180016/ 2018-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k180016-home-use-ipl-beauty-device-fda-510k.jpg K180016 - Home Use IPL Beauty Device K180016 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Mismon Technology Co., Ltd.. Cleared Mar 2018. https://www.510kdatabase.net/k180165/ 2018-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k180165-habib-endohpb-fda-510k.jpg K180165 - Habib EndoHPB K180165 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Emcision , Ltd.. Cleared Mar 2018. https://www.510kdatabase.net/k180438/ 2018-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k180438-bd-veritor-system-for-rapid-detection-fda-510k.jpg K180438 - BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit K180438 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd. Cleared Mar 2018. https://www.510kdatabase.net/k171863/ 2018-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k171863-anjon-bremer-halo-system-fda-510k.jpg K171863 - Anjon Bremer Halo System K171863 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Anjon Holdings, LLC. Cleared Mar 2018. https://www.510kdatabase.net/k171912/ 2018-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k171912-double-flexible-tip-wire-guides-fda-510k.jpg K171912 - Double Flexible Tip Wire Guides K171912 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Mar 2018. https://www.510kdatabase.net/k172148/ 2018-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k172148-anchorage-bone-plating-system-fda-510k.jpg K172148 - Anchorage Bone Plating System K172148 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker GmbH. Cleared Mar 2018. https://www.510kdatabase.net/k172264/ 2018-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k172264-otw-takeru-ptca-balloon-dilatation-fda-510k.jpg K172264 - OTW Takeru PTCA Balloon Dilatation Catheter K172264 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: KANEKA Corporation. Cleared Mar 2018. https://www.510kdatabase.net/k173237/ 2018-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k173237-moisyn-dry-mouth-oral-rinse-moisyn-dry-fda-510k.jpg K173237 - Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist K173237 is a FDA 510(k) cleared dental medical device. Manufacturer: Syendgen, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k173437/ 2018-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k173437-3m-attest-super-rapid-readout-fda-510k.jpg K173437 - 3M Attest Super Rapid Readout Biological Indicator 1492V, 3M Attest Auto-reader 490, 3M Attest Auto-reader 490H K173437 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Mar 2018. https://www.510kdatabase.net/k173499/ 2018-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k173499-exeter-v40-femoral-stem-hip-system-fda-510k.jpg K173499 - Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads K173499 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Orthopaedics. Cleared Mar 2018. https://www.510kdatabase.net/k173740/ 2018-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k173740-reprocessed-depuy-mitek-ablation-wand-fda-510k.jpg K173740 - Reprocessed DePuy Mitek Ablation Wand K173740 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Renovo, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k173930/ 2018-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k173930-python-plate-trial-instruments-fda-510k.jpg K173930 - PYTHON Plate Trial Instruments K173930 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Treace Medical Concepts, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k180475/ 2018-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k180475-caplox-ii-towerlox-mis-pedicle-screw-fda-510k.jpg K180475 - CapLOX II® / TowerLOX® MIS Pedicle Screw System K180475 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Captiva Spine, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k180579/ 2018-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k180579-ezee-retrieval-fda-510k.jpg K180579 - Ezee Retrieval K180579 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Genicon, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/den170029/ 2018-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/den170029-primestore-mtm-fda-510k.jpg DEN170029 - PrimeStore MTM DEN170029 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Longhorn Vaccines and Diagnostics, LLC. Cleared Mar 2018. https://www.510kdatabase.net/k173841/ 2018-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k173841-axs-catalyst-distal-access-catheter-fda-510k.jpg K173841 - AXS Catalyst Distal Access Catheter 058 x 115cm K173841 is a FDA 510(k) cleared neurology medical device. Manufacturer: Stryker. Cleared Mar 2018. https://www.510kdatabase.net/k171542/ 2018-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k171542-therabreath-dry-mouth-oral-rinse-fda-510k.jpg K171542 - TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges K171542 is a FDA 510(k) cleared dental medical device. Manufacturer: Dr. Harold Katz, LLC (Dba Therabreath. Cleared Mar 2018. https://www.510kdatabase.net/k171851/ 2018-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k171851-softxil-fda-510k.jpg K171851 - SOFTXIL K171851 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bistool. Cleared Mar 2018. https://www.510kdatabase.net/k171937/ 2018-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k171937-microlife-upper-arm-automatic-digital-fda-510k.jpg K171937 - Microlife Upper Arm Automatic Digital Blood Pressure Monitor K171937 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Microlife Intellectual Property GmbH. Cleared Mar 2018. https://www.510kdatabase.net/k172366/ 2018-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k172366-wrist-pulse-oximeter-fda-510k.jpg K172366 - Wrist Pulse Oximeter K172366 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Beijing Choice Electronic Technology Co., Ltd.. Cleared Mar 2018. https://www.510kdatabase.net/k172516/ 2018-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k172516-surgiquest-airseal-ifs-system-fda-510k.jpg K172516 - SurgiQuest AIRSEAL iFS System K172516 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Conmed Corporation. Cleared Mar 2018. https://www.510kdatabase.net/k172593/ 2018-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k172593-xcellistem-wound-powder-fda-510k.jpg K172593 - XCelliStem Wound Powder K172593 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stemsys. Cleared Mar 2018. https://www.510kdatabase.net/k172928/ 2018-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k172928-portable-x-ray-system-fda-510k.jpg K172928 - Portable X-ray System K172928 is a FDA 510(k) cleared radiology medical device. Manufacturer: Rolence Enterprise, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k173120/ 2018-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k173120-ccm-abutment-system-fda-510k.jpg K173120 - CCM Abutment System K173120 is a FDA 510(k) cleared dental medical device. Manufacturer: Innobiosurg Co., Ltd.. Cleared Mar 2018. https://www.510kdatabase.net/k173181/ 2018-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k173181-exspiron-1xi-fda-510k.jpg K173181 - ExSpiron 1Xi K173181 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respiratory Motion, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k173326/ 2018-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k173326-mis-connect-conical-connection-abutment-fda-510k.jpg K173326 - MIS CONNECT Conical Connection Abutment K173326 is a FDA 510(k) cleared dental medical device. Manufacturer: Mis Implants Technologies , Ltd.. Cleared Mar 2018. https://www.510kdatabase.net/k173358/ 2018-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k173358-artas-system-fda-510k.jpg K173358 - ARTAS System K173358 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Restoration Robotics, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k173611/ 2018-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k173611-syngo-application-software-fda-510k.jpg K173611 - syngo Application Software K173611 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k173752/ 2018-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k173752-si-screw-system-fda-510k.jpg K173752 - SI Screw System K173752 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zavation Medical Products, LLC. Cleared Mar 2018. https://www.510kdatabase.net/k173840/ 2018-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k173840-xpert-ctng-fda-510k.jpg K173840 - Xpert CT/NG K173840 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Cepheid. Cleared Mar 2018. https://www.510kdatabase.net/k173873/ 2018-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k173873-bd-bactec-peds-plusf-culture-vials-fda-510k.jpg K173873 - BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial K173873 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson and Company. Cleared Mar 2018. https://www.510kdatabase.net/k180129/ 2018-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k180129-imbio-segmentation-editing-tool-software-fda-510k.jpg K180129 - Imbio Segmentation Editing Tool software K180129 is a FDA 510(k) cleared radiology medical device. Manufacturer: Imbio, LLC. Cleared Mar 2018. https://www.510kdatabase.net/k180172/ 2018-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k180172-fluoroperm-30-paragon-thin-paflufocon-fda-510k.jpg K180172 - FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG K180172 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Paragon Vision Sciences. Cleared Mar 2018. https://www.510kdatabase.net/k180195/ 2018-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k180195-frigitronics-adapter-fda-510k.jpg K180195 - Frigitronics adapter K180195 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Phakos. Cleared Mar 2018. https://www.510kdatabase.net/k180404/ 2018-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k180404-3m-clarity-ultra-self-ligating-fda-510k.jpg K180404 - 3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System K180404 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Healthcare. Cleared Mar 2018. https://www.510kdatabase.net/k180411/ 2018-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k180411-memo-4d-fda-510k.jpg K180411 - MEMO 4D K180411 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sorin Group Italia S.R.L.. Cleared Mar 2018. https://www.510kdatabase.net/k180426/ 2018-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k180426-empower-h35-fda-510k.jpg K180426 - Empower H35 K180426 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Quanta System Spa. Cleared Mar 2018. https://www.510kdatabase.net/den160044/ 2018-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/den160044-acumen-hypotension-prediction-index-fda-510k.jpg DEN160044 - Acumen Hypotension Prediction Index (HPI) Feature Software DEN160044 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Mar 2018. https://www.510kdatabase.net/k171430/ 2018-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k171430-incontinence-treatment-device-model-fda-510k.jpg K171430 - Incontinence Treatment Device, Model LT2061 K171430 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Shenzhen Dongdixin Technology Co., Ltd.. Cleared Mar 2018. https://www.510kdatabase.net/k171808/ 2018-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k171808-tdm-plate-and-screw-system-fda-510k.jpg K171808 - TDM Plate and Screw System K171808 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tdm Co., Ltd.. Cleared Mar 2018. https://www.510kdatabase.net/k173180/ 2018-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k173180-mega-plus-spine-system-fda-510k.jpg K173180 - Mega Plus Spine System K173180 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Bk Meditech, Co., Ltd.. Cleared Mar 2018. https://www.510kdatabase.net/k173811/ 2018-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k173811-triway-tibiotalocalcaneal-ttc-fda-510k.jpg K173811 - TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System K173811 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: In2bones Sas. Cleared Mar 2018. https://www.510kdatabase.net/k173839/ 2018-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k173839-tissue-of-origin-test-kit-ffpe-fda-510k.jpg K173839 - Tissue of Origin Test Kit-FFPE K173839 is a FDA 510(k) cleared pathology medical device. Manufacturer: Cancer Genetics, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k180153/ 2018-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k180153-x-spine-cortical-bone-screw-system-fda-510k.jpg K180153 - X-spine Cortical Bone Screw System K180153 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: X-Spine Systems, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k180198/ 2018-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k180198-nuvasive-vuepoint-ii-oct-system-fda-510k.jpg K180198 - NuVasive® VuePoint® II OCT System K180198 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Mar 2018. https://www.510kdatabase.net/k180224/ 2018-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k180224-element-tl-fda-510k.jpg K180224 - ELEMENT-TL K180224 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Elemenic Co., Ltd.. Cleared Mar 2018. https://www.510kdatabase.net/k180227/ 2018-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k180227-polaris-spinal-growth-system-fda-510k.jpg K180227 - Polaris Spinal Growth System K180227 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer Biomet Spine, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k180330/ 2018-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k180330-liofilchem-mic-test-strip-mts-fda-510k.jpg K180330 - Liofilchem MIC Test Strip (MTS)- Linezolid 0.016 - 256ug/mL K180330 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Liofilchem S. R. L.. Cleared Mar 2018. https://www.510kdatabase.net/k180393/ 2018-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k180393-airo-computed-tomography-ct-x-ray-system-fda-510k.jpg K180393 - AIRO Computed Tomography (CT) X-ray System K180393 is a FDA 510(k) cleared radiology medical device. Manufacturer: Mobius Imaging, LLC. Cleared Mar 2018. https://www.510kdatabase.net/k180396/ 2018-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k180396-miradry-system-fda-510k.jpg K180396 - miraDry System K180396 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Miramar Labs, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k180405/ 2018-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k180405-fujifilm-endoscope-models-ec-600hl-and-fda-510k.jpg K180405 - FUJIFILM Endoscope Models EC-600HL and EC-600LS K180405 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fujifilm Corporation. Cleared Mar 2018. https://www.510kdatabase.net/k180406/ 2018-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k180406-ellipse-ydun-fda-510k.jpg K180406 - Ellipse Ydun K180406 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ellipse A/S. Cleared Mar 2018. https://www.510kdatabase.net/k180423/ 2018-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k180423-empower-h65-fda-510k.jpg K180423 - Empower H65 K180423 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Quanta System Spa. Cleared Mar 2018. https://www.510kdatabase.net/k180448/ 2018-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k180448-inspire-6m-hollow-fiber-oxygenator-fda-510k.jpg K180448 - INSPIRE 6M Hollow Fiber Oxygenator K180448 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sorin Group Italia S.R.L.. Cleared Mar 2018. https://www.510kdatabase.net/k171778/ 2018-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k171778-mr-wireless-gating-system-model-wgs-100-fda-510k.jpg K171778 - MR Wireless Gating System, Model WGS-100 K171778 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ivy Biomedical Systems, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k172012/ 2018-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k172012-star-rf-electrode-viva-rf-electrode-fda-510k.jpg K172012 - star RF Electrode, VIVA RF Electrode K172012 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Starmed Co., Ltd.. Cleared Mar 2018. https://www.510kdatabase.net/k172266/ 2018-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k172266-dynarex-three-way-stopcock-fda-510k.jpg K172266 - Dynarex Three-Way Stopcock K172266 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Dynarex Corporation. Cleared Mar 2018. https://www.510kdatabase.net/k172431/ 2018-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k172431-cardiovascular-analzyer-fda-510k.jpg K172431 - Cardiovascular Analzyer K172431 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Physiowave, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k172795/ 2018-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k172795-infrared-thermometer-fda-510k.jpg K172795 - Infrared Thermometer K172795 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen Jumper Medical Equipment Co., Ltd.. Cleared Mar 2018. https://www.510kdatabase.net/k173203/ 2018-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k173203-athena-gtx-device-management-suite-fda-510k.jpg K173203 - Athena GTX Device Management Suite (ADMS) Software K173203 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Athena Gtx. Cleared Mar 2018. https://www.510kdatabase.net/k173794/ 2018-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k173794-amistem-h-proximal-coating-amistem-p-fda-510k.jpg K173794 - AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared K173794 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Mar 2018. https://www.510kdatabase.net/k173798/ 2018-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k173798-simplexa-hsv-1-2-direct-simplexa-hsv-1-fda-510k.jpg K173798 - Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack K173798 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Diasorin Molecular, LLC. Cleared Mar 2018. https://www.510kdatabase.net/k173980/ 2018-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k173980-specular-microscope-cem-530-fda-510k.jpg K173980 - Specular Microscope CEM-530 K173980 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Nidek Co., Ltd.. Cleared Mar 2018. https://www.510kdatabase.net/k180104/ 2018-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k180104-trojan-chain-reaction-natural-rubber-fda-510k.jpg K180104 - Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant K180104 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Church & Dwight Co., Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k180421/ 2018-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k180421-natus-neuroworks-fda-510k.jpg K180421 - Natus NeuroWorks K180421 is a FDA 510(k) cleared neurology medical device. Manufacturer: Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). Cleared Mar 2018. https://www.510kdatabase.net/k180429/ 2018-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k180429-advincula-delineator-uterine-manipulator-fda-510k.jpg K180429 - Advincula Delineator Uterine Manipulator K180429 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: CooperSurgical, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k171817/ 2018-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k171817-biodesign-diaphragmatic-hernia-graft-fda-510k.jpg K171817 - Biodesign Diaphragmatic Hernia Graft K171817 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cook Biotech Incorporated. Cleared Mar 2018. https://www.510kdatabase.net/k173459/ 2018-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k173459-olympus-small-intestinal-capsule-fda-510k.jpg K173459 - Olympus Small Intestinal Capsule Endoscope System K173459 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Mar 2018. https://www.510kdatabase.net/k173694/ 2018-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k173694-sterizone-vp4-sterilizer-fda-510k.jpg K173694 - STERIZONE VP4 Sterilizer K173694 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Tso3, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k173785/ 2018-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k173785-custom-clear-aligner-system-fda-510k.jpg K173785 - Custom Clear Aligner System K173785 is a FDA 510(k) cleared dental medical device. Manufacturer: Derby Dental Laboratory. Cleared Mar 2018. https://www.510kdatabase.net/k173792/ 2018-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k173792-elia-pr3s-immunoassay-fda-510k.jpg K173792 - EliA PR3s Immunoassay K173792 is a FDA 510(k) cleared immunology medical device. Manufacturer: Phadia AB. Cleared Mar 2018. https://www.510kdatabase.net/k180106/ 2018-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k180106-thinkqa-fda-510k.jpg K180106 - ThinkQA K180106 is a FDA 510(k) cleared radiology medical device. Manufacturer: Dosisoft. Cleared Mar 2018. https://www.510kdatabase.net/k180374/ 2018-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k180374-voluson-s8-voluson-s10-voluson-s10-fda-510k.jpg K180374 - Voluson S8/ Voluson S10/ Voluson S10 Expert K180374 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Mar 2018. https://www.510kdatabase.net/k173229/ 2018-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k173229-preview-digital-pregnancy-test-fda-510k.jpg K173229 - Preview Digital Pregnancy Test K173229 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.. Cleared Mar 2018. https://www.510kdatabase.net/k173583/ 2018-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k173583-exactech-novation-and-acumatch-e-hxl-fda-510k.jpg K173583 - Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners K173583 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k173734/ 2018-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k173734-rocajj-soft-stents-fda-510k.jpg K173734 - RocaJJ Soft Stents K173734 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Promepla Sam. Cleared Mar 2018. https://www.510kdatabase.net/k173779/ 2018-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k173779-rexmono-pdrex-fda-510k.jpg K173779 - REXMONO, PDREX K173779 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sm Eng Co., Ltd.. Cleared Mar 2018. https://www.510kdatabase.net/k180262/ 2018-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k180262-sicat-endo-fda-510k.jpg K180262 - SICAT Endo K180262 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sicat GmbH & Co. KG. Cleared Mar 2018. https://www.510kdatabase.net/k180450/ 2018-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k180450-corvocet-biopsy-system-fda-510k.jpg K180450 - Corvocet Biopsy System K180450 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k173628/ 2018-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k173628-acclarent-ent-navigation-system-fda-510k.jpg K173628 - Acclarent ENT Navigation System K173628 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Acclarent, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k162616/ 2018-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k162616-wrist-type-blood-pressure-monitor-fda-510k.jpg K162616 - Wrist Type Blood Pressure Monitor K162616 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Xuzhou Yongkang Electronic Science Technology Co., Ltd.. Cleared Mar 2018. https://www.510kdatabase.net/k171764/ 2018-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k171764-fixed-core-wire-guides-fda-510k.jpg K171764 - Fixed Core Wire Guides K171764 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Mar 2018. https://www.510kdatabase.net/k171820/ 2018-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k171820-transjugular-liver-access-sets-fda-510k.jpg K171820 - Transjugular Liver Access Sets K171820 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Mar 2018. https://www.510kdatabase.net/k172057/ 2018-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k172057-zimmon-pancreatic-stentsstent-sets-fda-510k.jpg K172057 - Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Pancreatic Wedge Stent and Introducer Set K172057 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Ireland, Ltd.. Cleared Mar 2018. https://www.510kdatabase.net/k172799/ 2018-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k172799-positional-sleep-assessment-system-fda-510k.jpg K172799 - Positional Sleep Assessment System (PoSAS) software K172799 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Advanced Brain Monitoring. Cleared Mar 2018. https://www.510kdatabase.net/k173078/ 2018-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k173078-powder-free-clear-vinyl-patient-fda-510k.jpg K173078 - Powder-free Clear Vinyl Patient Examination Gloves K173078 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Yongsheng Medical Products Co., Ltd.. Cleared Mar 2018. https://www.510kdatabase.net/k173388/ 2018-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k173388-exactech-equinoxe-stemless-shoulder-fda-510k.jpg K173388 - Exactech Equinoxe Stemless Shoulder K173388 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k173426/ 2018-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k173426-prevena-plus-incision-management-fda-510k.jpg K173426 - PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System K173426 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Kci USA, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k173481/ 2018-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k173481-amsco-evolution-medium-steam-sterilizer-fda-510k.jpg K173481 - Amsco Evolution Medium Steam Sterilizer K173481 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Mar 2018. https://www.510kdatabase.net/k173682/ 2018-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k173682-l300-go-system-fda-510k.jpg K173682 - L300 Go System K173682 is a FDA 510(k) cleared neurology medical device. Manufacturer: Bioness, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k173690/ 2018-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k173690-grass-twin-fda-510k.jpg K173690 - Grass TWin K173690 is a FDA 510(k) cleared neurology medical device. Manufacturer: Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). Cleared Mar 2018. https://www.510kdatabase.net/k173796/ 2018-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k173796-parietex-surgical-mesh-modified-into-fda-510k.jpg K173796 - Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references) K173796 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sofradim Production. Cleared Mar 2018. https://www.510kdatabase.net/k173812/ 2018-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k173812-catalyst-csr-3-peg-glenoids-fda-510k.jpg K173812 - Catalyst CSR 3 Peg Glenoids K173812 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Catalyst Orthoscience, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k173904/ 2018-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k173904-cats-tonometer-prism-fda-510k.jpg K173904 - CATS Tonometer Prism K173904 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Cats Tonometer, LLC. Cleared Mar 2018. https://www.510kdatabase.net/k173939/ 2018-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k173939-quantib-brain-fda-510k.jpg K173939 - Quantib Brain K173939 is a FDA 510(k) cleared radiology medical device. Manufacturer: Quantib B.V.. Cleared Mar 2018. https://www.510kdatabase.net/k180057/ 2018-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k180057-vortek-ureteral-double-loop-stent-fda-510k.jpg K180057 - VORTEK URETERAL DOUBLE LOOP STENT K180057 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Coloplast Corp.. Cleared Mar 2018. https://www.510kdatabase.net/k180061/ 2018-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k180061-ultracor-twirl-breast-tissue-marker-fda-510k.jpg K180061 - UltraCor Twirl Breast Tissue Marker K180061 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bard Peripheral Vascular, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k180159/ 2018-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k180159-klassic-knee-system-fda-510k.jpg K180159 - Klassic® Knee System K180159 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Total Joint Orthopedics, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k180394/ 2018-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k180394-brightmatter-plan-160-fda-510k.jpg K180394 - BrightMatter Plan 1.6.0 K180394 is a FDA 510(k) cleared radiology medical device. Manufacturer: Synaptive Medical, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k171150/ 2018-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k171150-aw-100-fda-510k.jpg K171150 - AW-100 K171150 is a FDA 510(k) cleared dental medical device. Manufacturer: Micron Corporation. Cleared Mar 2018. https://www.510kdatabase.net/k171320/ 2018-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k171320-armar-artis-small-fragment-and-fda-510k.jpg K171320 - ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS Humerus and Olecranon Plates & MBOSS/FIXION Screws, ARMAR / ARTIS Tibia and Buttress Plates & MBOSS/FIXION Screws, ARMAR / ARTIS 2.4mm Plates & MBOSS/FIXION Screws, ARMAR/ ARTISClavical Hook Plate & MBOSS/FIXION Screws, ARMAR/ ARTIS Metaphyseal Plate & MBOSS/FIXION Screws, ARMAR / ARTISCalcaneal Plate & MBOSS/FIXION Screws K171320 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Meril Healthcare Pvt. , Ltd.. Cleared Mar 2018. https://www.510kdatabase.net/k172115/ 2018-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k172115-navigated-instrument-system-fda-510k.jpg K172115 - Navigated Instrument System K172115 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthofix, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k172892/ 2018-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k172892-neuro-assessment-system-nas-1000-fda-510k.jpg K172892 - Neuro Assessment System NAS-1000 K172892 is a FDA 510(k) cleared neurology medical device. Manufacturer: Headsense Medical, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k173075/ 2018-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k173075-zymot-icsi-sperm-separation-device-fda-510k.jpg K173075 - ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml) K173075 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Dxnow, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k173249/ 2018-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k173249-cd-horizon-spinal-system-fda-510k.jpg K173249 - CD HORIZON™ Spinal System K173249 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k173323/ 2018-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k173323-anastoclip-gc-closure-system-fda-510k.jpg K173323 - AnastoClip GC Closure System K173323 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: LeMaitre Vascular, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k173440/ 2018-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k173440-carriere-slx-3d-clear-fda-510k.jpg K173440 - Carriere SLX 3D Clear K173440 is a FDA 510(k) cleared dental medical device. Manufacturer: Ortho Organizers, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k173500/ 2018-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k173500-nmf004a-fda-510k.jpg K173500 - NMF004A K173500 is a FDA 510(k) cleared dental medical device. Manufacturer: GC America, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k173605/ 2018-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k173605-iqmr-fda-510k.jpg K173605 - iQMR K173605 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medic Vision - Imaging Solutions, Ltd.. Cleared Mar 2018. https://www.510kdatabase.net/k173625/ 2018-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k173625-syngoct-clinical-extensions-fda-510k.jpg K173625 - syngo.CT Clinical Extensions K173625 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k173713/ 2018-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k173713-hs70a-diagnostic-ultrasound-system-fda-510k.jpg K173713 - HS70A Diagnostic Ultrasound System K173713 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Medison Co., Ltd.. Cleared Mar 2018. https://www.510kdatabase.net/k173769/ 2018-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k173769-dmax-coloring-liquid-fda-510k.jpg K173769 - DMAX Coloring Liquid K173769 is a FDA 510(k) cleared dental medical device. Manufacturer: Dmax Co., Ltd.. Cleared Mar 2018. https://www.510kdatabase.net/k173772/ 2018-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k173772-breathid-hp-system-fda-510k.jpg K173772 - BreathID Hp System K173772 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Exalenz Bioscience , Ltd.. Cleared Mar 2018. https://www.510kdatabase.net/k173777/ 2018-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k173777-breathid-hp-lab-system-fda-510k.jpg K173777 - BreathID Hp Lab System K173777 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Exalenz Bioscience , Ltd.. Cleared Mar 2018. https://www.510kdatabase.net/k180044/ 2018-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k180044-sirolaser-blue-fda-510k.jpg K180044 - SIROLaser Blue K180044 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Dentsply Sirona. Cleared Mar 2018. https://www.510kdatabase.net/k180086/ 2018-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k180086-gyrus-acmi-ezdilate-3-stage-balloon-fda-510k.jpg K180086 - Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter K180086 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Gyrus Acmi, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k180092/ 2018-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k180092-intellitorq-fda-510k.jpg K180092 - Intellitorq K180092 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Gauthier Biomedical, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k180105/ 2018-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k180105-indigo-aspiration-system-penumbra-fda-510k.jpg K180105 - Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra Engine Pump Canister K180105 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Penumbra, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k180135/ 2018-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k180135-thd-anopress-with-thd-sensyprobe-fda-510k.jpg K180135 - THD Anopress with THD SensyProbe K180135 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Thd Spa. Cleared Mar 2018. https://www.510kdatabase.net/k180171/ 2018-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k180171-pillcam-patency-system-fda-510k.jpg K180171 - PillCam Patency System K180171 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Given Imaging , Ltd.. Cleared Mar 2018. https://www.510kdatabase.net/k180326/ 2018-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k180326-icobrain-fda-510k.jpg K180326 - icobrain K180326 is a FDA 510(k) cleared radiology medical device. Manufacturer: Icometrix. Cleared Mar 2018. https://www.510kdatabase.net/k180335/ 2018-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k180335-accutension-smartphone-auscultatory-fda-510k.jpg K180335 - Accutension Smartphone Auscultatory Blood K180335 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shanghai Hulu Devices Co., Ltd.. Cleared Mar 2018. https://www.510kdatabase.net/k171802/ 2018-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k171802-aleve-direct-therapy-aleve-direct-fda-510k.jpg K171802 - ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device) K171802 is a FDA 510(k) cleared neurology medical device. Manufacturer: Bayer Healthcare, LLC. Cleared Mar 2018. https://www.510kdatabase.net/k171810/ 2018-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k171810-cone-tip-ureteral-catheter-rutner-fda-510k.jpg K171810 - Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter K171810 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Mar 2018. https://www.510kdatabase.net/k171939/ 2018-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k171939-alvue-balloon-dilation-system-fda-510k.jpg K171939 - ALVUE Balloon Dilation System K171939 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Globus Medical, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k172758/ 2018-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k172758-rotatable-snares-non-rotatable-snares-fda-510k.jpg K172758 - Rotatable Snares, Non-Rotatable Snares K172758 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Zhejiang Chuangxiang Medical Technology Co., Ltd.. Cleared Mar 2018. https://www.510kdatabase.net/k172810/ 2018-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k172810-port-x-iv-fda-510k.jpg K172810 - PORT-X IV K172810 is a FDA 510(k) cleared radiology medical device. Manufacturer: Genoray Co., Ltd.. Cleared Mar 2018. https://www.510kdatabase.net/k172818/ 2018-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k172818-lmt-3000-fda-510k.jpg K172818 - LMT-3000 K172818 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lameditech Co. , Ltd.. Cleared Mar 2018. https://www.510kdatabase.net/k173114/ 2018-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k173114-primemidline-catheters-fda-510k.jpg K173114 - primeMidline Catheters K173114 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Pfm Medical, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k180156/ 2018-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k180156-sp-fix-spinous-process-fixation-plate-fda-510k.jpg K180156 - SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System K180156 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k180196/ 2018-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k180196-on-call-express-mobile-blood-glucose-fda-510k.jpg K180196 - On Call Express Mobile Blood Glucose Monitoring System K180196 is a FDA 510(k) cleared chemistry medical device. Manufacturer: ACON Laboratories, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k180321/ 2018-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k180321-aesculap-optilene-nonabsorbable-suture-fda-510k.jpg K180321 - Aesculap Optilene Nonabsorbable Suture K180321 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k180350/ 2018-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k180350-dornier-medilas-h-solvo-35-laser-fda-510k.jpg K180350 - Dornier Medilas H Solvo 35 Laser K180350 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Dornier Medtech America. Cleared Mar 2018. https://www.510kdatabase.net/k171750/ 2018-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k171750-citric-complete-dry-citric-acid-45x-fda-510k.jpg K171750 - Citric Complete Dry Citric Acid (45X) K171750 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Dimesol USA, LLC. Cleared Mar 2018. https://www.510kdatabase.net/k172267/ 2018-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k172267-irene-thoracolumbar-fixation-system-fda-510k.jpg K172267 - IRENE Thoracolumbar Fixation System K172267 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Tianjin Zhengtian Medical Instrument Co., Ltd.. Cleared Mar 2018. https://www.510kdatabase.net/k172381/ 2018-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k172381-digitimer-ds7ap-constant-current-fda-510k.jpg K172381 - Digitimer DS7AP Constant Current Stimulator K172381 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Digitimer , Ltd.. Cleared Mar 2018. https://www.510kdatabase.net/k173262/ 2018-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k173262-reprocessed-viewflex-xtra-ice-fda-510k.jpg K173262 - Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter K173262 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Innovative Health, LLC. Cleared Mar 2018. https://www.510kdatabase.net/k173356/ 2018-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k173356-ingenia-elition-s-and-ingenia-elition-fda-510k.jpg K173356 - Ingenia Elition S and Ingenia Elition X R5.4 K173356 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Mar 2018. https://www.510kdatabase.net/k173494/ 2018-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k173494-orthosteady-g-bone-cement-fda-510k.jpg K173494 - OrthoSteady G Bone Cement K173494 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: G21, S.R.L.. Cleared Mar 2018. https://www.510kdatabase.net/den170046/ 2018-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/den170046-23andme-pgs-genetic-health-risk-report-fda-510k.jpg DEN170046 - 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) DEN170046 is a FDA 510(k) cleared pathology medical device. Manufacturer: 23AndMe, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k171715/ 2018-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k171715-hammertube-system-fda-510k.jpg K171715 - HammerTube System K171715 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Paragon 28. Cleared Mar 2018. https://www.510kdatabase.net/k172062/ 2018-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k172062-allergiend-st-9-multiple-skin-test-fda-510k.jpg K172062 - AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray K172062 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medscience Science Research Group, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k172663/ 2018-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k172663-cytology-brush-fda-510k.jpg K172663 - Cytology Brush K172663 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Micro-Tech (Nanjing) Co., Ltd.. Cleared Mar 2018. https://www.510kdatabase.net/k172872/ 2018-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k172872-depuy-synthes-femoral-neck-system-fda-510k.jpg K172872 - DePuy Synthes Femoral Neck System K172872 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Synthes. Cleared Mar 2018. https://www.510kdatabase.net/k173453/ 2018-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k173453-valeo-ccsc-with-lumen-interbody-fusion-fda-510k.jpg K173453 - Valeo® C+CSC with Lumen Interbody Fusion Device K173453 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Amedica Corp.. Cleared Mar 2018. https://www.510kdatabase.net/k173723/ 2018-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k173723-empowr-universal-tibial-baseplate-fda-510k.jpg K173723 - EMPOWR Universal Tibial Baseplate K173723 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Encore Medical, L.P.. Cleared Mar 2018. https://www.510kdatabase.net/k173741/ 2018-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k173741-reprocessed-arthocare-ablation-wand-fda-510k.jpg K173741 - Reprocessed ArthoCare Ablation Wand K173741 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Renovo, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k173879/ 2018-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k173879-minimed-mio-advance-infusion-set-fda-510k.jpg K173879 - MiniMed Mio Advance infusion set K173879 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Unomedical A/S. Cleared Mar 2018. https://www.510kdatabase.net/k173942/ 2018-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k173942-blue-non-sterile-powder-free-nitrile-fda-510k.jpg K173942 - Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs K173942 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Central Medicare Sdn Bhd. Cleared Mar 2018. https://www.510kdatabase.net/k180334/ 2018-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k180334-legion-knee-system-fda-510k.jpg K180334 - LEGION Knee System K180334 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k162366/ 2018-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k162366-omega-vl-fda-510k.jpg K162366 - Omega VL K162366 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ov World Co., Ltd.. Cleared Mar 2018. https://www.510kdatabase.net/k170304/ 2018-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k170304-astell-umb-220-umb-230-umb-240-fda-510k.jpg K170304 - Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers K170304 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Astell Scientific Limited. Cleared Mar 2018. https://www.510kdatabase.net/k171129/ 2018-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k171129-co-check-pro-co-screen-fda-510k.jpg K171129 - CO Check Pro, CO Screen K171129 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: MD Diagnostics Limited. Cleared Mar 2018. https://www.510kdatabase.net/k171214/ 2018-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k171214-infrared-thermometer-fda-510k.jpg K171214 - Infrared Thermometer K171214 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shenzhen Brav Electronic Technologies Co., Ltd.. Cleared Mar 2018. https://www.510kdatabase.net/k171655/ 2018-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k171655-cobas-m-511-integrated-hematology-fda-510k.jpg K171655 - cobas m 511 integrated hematology analyzer K171655 is a FDA 510(k) cleared hematology medical device. Manufacturer: Roche Diagnostics Hematology, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k172103/ 2018-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k172103-flowtron-dvt5-small-calf-garment-fda-510k.jpg K172103 - Flowtron DVT5 Small Calf Garment K172103 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Getinge (Suzhou) Co., Ltd.. Cleared Mar 2018. https://www.510kdatabase.net/k172135/ 2018-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k172135-uct-computed-tomography-x-ray-system-fda-510k.jpg K172135 - uCT Computed Tomography X-ray System K172135 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Mar 2018. https://www.510kdatabase.net/k172256/ 2018-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k172256-softvue-fda-510k.jpg K172256 - SoftVue K172256 is a FDA 510(k) cleared radiology medical device. Manufacturer: Delphinus Medical Technologies. Cleared Mar 2018. https://www.510kdatabase.net/k172331/ 2018-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k172331-type-i-type-ii-type-iii-type-iv-fda-510k.jpg K172331 - Type I, Type II, Type III, Type IV K172331 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Lepu Medical Technology (Beijing) Co., Ltd.. Cleared Mar 2018. https://www.510kdatabase.net/k172485/ 2018-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k172485-footmotion-hammertoe-fda-510k.jpg K172485 - Footmotion HammerToe K172485 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Newclip Technics. Cleared Mar 2018. https://www.510kdatabase.net/k172590/ 2018-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k172590-spectra-optia-apheresis-system-fda-510k.jpg K172590 - Spectra Optia Apheresis System K172590 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Terumobct, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k172601/ 2018-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k172601-next-generation-ibot-fda-510k.jpg K172601 - Next Generation iBOT K172601 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Deka Research & Development Corp.. Cleared Mar 2018. https://www.510kdatabase.net/k172972/ 2018-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k172972-wrist-type-automatic-blood-pressure-fda-510k.jpg K172972 - Wrist Type Automatic Blood Pressure Monitor K172972 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Jiacom Technology CO ., Ltd.. Cleared Mar 2018. https://www.510kdatabase.net/k173223/ 2018-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k173223-ologen-collagen-matrix-fda-510k.jpg K173223 - ologen Collagen Matrix K173223 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aeon Astron Europe B.V.. Cleared Mar 2018. https://www.510kdatabase.net/k173256/ 2018-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k173256-system-1-endo-liquid-chemical-fda-510k.jpg K173256 - System 1 endo Liquid Chemical Sterilant Processing System K173256 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Mar 2018. https://www.510kdatabase.net/k173281/ 2018-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k173281-ligasure-exact-dissector-nano-coated-fda-510k.jpg K173281 - LigaSure Exact Dissector, Nano-coated K173281 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien. Cleared Mar 2018. https://www.510kdatabase.net/k173312/ 2018-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k173312-probx-software-fda-510k.jpg K173312 - ProBx Software K173312 is a FDA 510(k) cleared radiology medical device. Manufacturer: Harmonus, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k173346/ 2018-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k173346-lensar-laser-system-fs-3d-lls-fs-3d-fda-510k.jpg K173346 - LENSAR Laser System - fs 3D (LLS-fs 3D) K173346 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Lensar, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k173428/ 2018-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k173428-verify-chemical-indicator-for-s40-fda-510k.jpg K173428 - VERIFY Chemical Indicator for S40 Sterilant K173428 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Mar 2018. https://www.510kdatabase.net/k173447/ 2018-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k173447-vacvia-7-day-therapy-system-kit-vacvia-fda-510k.jpg K173447 - V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure Wound Therapy Unit K173447 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Kci USA, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k173544/ 2018-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k173544-phoenix-wound-matrix-fda-510k.jpg K173544 - Phoenix Wound Matrix K173544 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Nanofiber Solutions, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k173624/ 2018-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k173624-origio-handling-without-phenol-red-cat-fda-510k.jpg K173624 - ORIGIO® Handling™ without phenol red (Cat. No. 8310), ORIGIO® Handling™ with phenol red (Cat. No. 8311) K173624 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Origio A/S. Cleared Mar 2018. https://www.510kdatabase.net/k173704/ 2018-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k173704-immunocap-tryptase-immunocap-tryptase-fda-510k.jpg K173704 - ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip K173704 is a FDA 510(k) cleared immunology medical device. Manufacturer: Phadia AB. Cleared Mar 2018. https://www.510kdatabase.net/k173731/ 2018-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k173731-sage-vitrification-kit-art-8025-and-fda-510k.jpg K173731 - SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031) K173731 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: CooperSurgical, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k180265/ 2018-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k180265-compact-touch-ophthalmic-ultrasound-fda-510k.jpg K180265 - COMPACT TOUCH Ophthalmic Ultrasound System K180265 is a FDA 510(k) cleared radiology medical device. Manufacturer: Quantel Medical. Cleared Mar 2018. https://www.510kdatabase.net/k171703/ 2018-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k171703-puma-system-fda-510k.jpg K171703 - PUMA System K171703 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Panther Orthopedics, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k171915/ 2018-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k171915-nathanson-transcystic-bile-duct-stone-fda-510k.jpg K171915 - Nathanson Transcystic Bile Duct Stone Exploration Pack K171915 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Mar 2018. https://www.510kdatabase.net/k172500/ 2018-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k172500-technoweb-surgical-mask-fda-510k.jpg K172500 - Technoweb Surgical Mask K172500 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Yts Global, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k172820/ 2018-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k172820-microscope-navigation-software-fda-510k.jpg K172820 - Microscope Navigation Software K172820 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Mar 2018. https://www.510kdatabase.net/k172916/ 2018-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k172916-fujifilm-endoscope-models-eg-760r-eg-fda-510k.jpg K172916 - FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603 K172916 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fujifilm Corporation. Cleared Mar 2018. https://www.510kdatabase.net/k173488/ 2018-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k173488-celerity-20-hp-challenge-pack-fda-510k.jpg K173488 - CELERITY 20 HP Challenge Pack K173488 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Mar 2018. https://www.510kdatabase.net/k173680/ 2018-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k173680-sapphire-ii-pro-fda-510k.jpg K173680 - Sapphire II PRO K173680 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Orbusneich Medical Trading, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k173788/ 2018-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k173788-arthrex-corkscrew-ft-fda-510k.jpg K173788 - Arthrex Corkscrew FT K173788 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k173806/ 2018-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k173806-corpath-grx-system-fda-510k.jpg K173806 - CorPath GRX System K173806 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Corindus, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/k180109/ 2018-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k180109-starband-starlight-st-louis-band-fda-510k.jpg K180109 - STARband, STARlight, St. Louis Band K180109 is a FDA 510(k) cleared neurology medical device. Manufacturer: Orthomerica Products, Inc.. Cleared Mar 2018. https://www.510kdatabase.net/den160029/ 2018-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/den160029-skinpen-precision-system-fda-510k.jpg DEN160029 - SkinPen Precision System DEN160029 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bellus Medical, LLC. Cleared Mar 2018. https://www.510kdatabase.net/k172750/ 2018-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k172750-wireless-probe-type-ultrasound-scanner-fda-510k.jpg K172750 - Wireless Probe Type Ultrasound Scanner (Model:UProbe-C K172750 is a FDA 510(k) cleared radiology medical device. Manufacturer: Guangzhou Sonostar Technologies Co., Ltd.. Cleared Feb 2018. https://www.510kdatabase.net/k172797/ 2018-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k172797-ecg-cableleadwires-fda-510k.jpg K172797 - ECG Cable/Leadwires K172797 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Coreray Technology, Ltd.. Cleared Feb 2018. https://www.510kdatabase.net/k172868/ 2018-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k172868-optilite-c-reactive-protein-fda-510k.jpg K172868 - Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls K172868 is a FDA 510(k) cleared immunology medical device. Manufacturer: The Binding Site Group , Ltd.. Cleared Feb 2018. https://www.510kdatabase.net/k173145/ 2018-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k173145-ceremetrix-silver-fda-510k.jpg K173145 - CereMetrix Silver K173145 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ceremetrix Corp. Cleared Feb 2018. https://www.510kdatabase.net/k173186/ 2018-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k173186-s-series-electrodes-models-s55105-fda-510k.jpg K173186 - S Series Electrodes / Models S55105, S80120, SG4040, SG4368, SG50D, SG5050, SG5075, SG50100, SG5795, SG60147, SG7090, & SG75D K173186 is a FDA 510(k) cleared neurology medical device. Manufacturer: Everyway Medical Instruments Co.,Ltd. Cleared Feb 2018. https://www.510kdatabase.net/k173367/ 2018-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k173367-mc-300-nebulizer-fda-510k.jpg K173367 - MC 300* Nebulizer K173367 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Trudell Medical International. Cleared Feb 2018. https://www.510kdatabase.net/k173633/ 2018-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k173633-verify-all-in-one-steam-reusable-test-fda-510k.jpg K173633 - VERIFY All-In-One STEAM Reusable Test Pack, VERIFY All-In-One STEAM Reusable Test Pack with Step Counter, VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag K173633 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Feb 2018. https://www.510kdatabase.net/k173678/ 2018-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k173678-diode-laser-cap-fda-510k.jpg K173678 - Diode Laser Cap K173678 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cosmo Far East Technology Limited. Cleared Feb 2018. https://www.510kdatabase.net/k173691/ 2018-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k173691-sofia-lyme-fia-sofia-2-analyzer-sofia-fda-510k.jpg K173691 - Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack K173691 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Quidel Corporation. Cleared Feb 2018. https://www.510kdatabase.net/k173707/ 2018-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k173707-p200te-fda-510k.jpg K173707 - P200TE K173707 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Optos Plc.. Cleared Feb 2018. https://www.510kdatabase.net/k173729/ 2018-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k173729-revian-red-fda-510k.jpg K173729 - REVIAN RED K173729 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Photonmd, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k173736/ 2018-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k173736-trackx-fda-510k.jpg K173736 - TrackX K173736 is a FDA 510(k) cleared radiology medical device. Manufacturer: Track X Technology, LLC. Cleared Feb 2018. https://www.510kdatabase.net/k173739/ 2018-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k173739-aloka-arietta-850-fda-510k.jpg K173739 - ALOKA ARIETTA 850 K173739 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hitachi Healthcare Americas Corporation. Cleared Feb 2018. https://www.510kdatabase.net/k173763/ 2018-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k173763-iovera-system-fda-510k.jpg K173763 - iovera system K173763 is a FDA 510(k) cleared neurology medical device. Manufacturer: Myoscience, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k173817/ 2018-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k173817-liofilchem-mic-test-strip-mts-fda-510k.jpg K173817 - Liofilchem MIC Test Strip (MTS), Ceftazidime-avibactam 0.016/4 - 256/4 µg/mL K173817 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Liofilchem S. R. L.. Cleared Feb 2018. https://www.510kdatabase.net/k180242/ 2018-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k180242-hero-symphony-hero-es-hero-soloduet-fda-510k.jpg K180242 - HeRO Symphony, HeRO ES, HeRO solo/duet K180242 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medical Predictive Science Corporation. Cleared Feb 2018. https://www.510kdatabase.net/k180244/ 2018-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k180244-ensoetm-fda-510k.jpg K180244 - EnsoETM K180244 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Advanced Cooling Therapy, Inc. D/B/A Attune Medical. Cleared Feb 2018. https://www.510kdatabase.net/k180255/ 2018-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k180255-clungene-multi-drug-test-dip-card-fda-510k.jpg K180255 - CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup K180255 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Hangzhou Clongene Biotech Co., Ltd.. Cleared Feb 2018. https://www.510kdatabase.net/k170623/ 2018-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k170623-ace-hemoglobin-a1c-hba1c-reagent-fda-510k.jpg K170623 - ACE Hemoglobin A1c (HbA1c) Reagent K170623 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Alfa Wassermann Diagnostic Technologies, LLC. Cleared Feb 2018. https://www.510kdatabase.net/k171476/ 2018-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k171476-selectalyte-electrolyte-analyzer-na-k-fda-510k.jpg K171476 - SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) K171476 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Awareness Technology, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k172042/ 2018-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k172042-neuronav-system-neurosmart-system-fda-510k.jpg K172042 - NeuroNav System, NeuroSmart System K172042 is a FDA 510(k) cleared neurology medical device. Manufacturer: Alpha Omega Engineering , Ltd.. Cleared Feb 2018. https://www.510kdatabase.net/k172044/ 2018-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k172044-cotton-huibregtse-stent-cotton-leung-fda-510k.jpg K172044 - Cotton-Huibregtse Stent, Cotton-Leung Biliary Stent, Cotton-Leung Sof-Flex Biliary Stent, Soehendra Tannenbaum Biliary Stent, Zimmon Biliary Stent, Guiding Catheter, Pushing catheter, Fusion pushing catheter, Stent Introducer Set, Fusion Oasis One Action Sent Introduction System, Zimmon Biliary Stent Set, Oasis One Action Stent Introduction System, Solus Double Pigtail Stent and Introduction System, Cotton-Huibregtse Biliary Stent Set, Cotton-Leung Biliary Stent Set, Oasis One Action S K172044 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Ireland, Ltd.. Cleared Feb 2018. https://www.510kdatabase.net/k173275/ 2018-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k173275-omnichroma-fda-510k.jpg K173275 - OMNICHROMA K173275 is a FDA 510(k) cleared dental medical device. Manufacturer: Tokuyama Dental Corporation. Cleared Feb 2018. https://www.510kdatabase.net/k173324/ 2018-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k173324-alta-anterior-cervical-interbody-spacer-fda-510k.jpg K173324 - ALTA Anterior Cervical Interbody Spacer K173324 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Astura Medical. Cleared Feb 2018. https://www.510kdatabase.net/k173343/ 2018-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k173343-zygomatic-implant-system-fda-510k.jpg K173343 - Zygomatic Implant System K173343 is a FDA 510(k) cleared dental medical device. Manufacturer: Southern Implants (Pty), Ltd.. Cleared Feb 2018. https://www.510kdatabase.net/k173683/ 2018-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k173683-liaison-brahms-pct-ii-gen-liaison-fda-510k.jpg K173683 - LIAISON BRAHMS PCT II GEN, LIAISON Control BRAHMS PCT II GEN, LIAISON BRAHMS PCT II GEN Verifiers K173683 is a FDA 510(k) cleared microbiology medical device. Manufacturer: DiaSorin, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k173746/ 2018-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k173746-activmotion-range-fda-510k.jpg K173746 - Activmotion Range K173746 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Newclip Technics. Cleared Feb 2018. https://www.510kdatabase.net/k180237/ 2018-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k180237-rezum-system-fda-510k.jpg K180237 - Rezum System K180237 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Nxthera, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k170175/ 2018-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k170175-endoseal-mta-fda-510k.jpg K170175 - ENDOSEAL MTA K170175 is a FDA 510(k) cleared dental medical device. Manufacturer: Maruchi. Cleared Feb 2018. https://www.510kdatabase.net/k171637/ 2018-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k171637-opclear-system-fda-510k.jpg K171637 - OpClear System K171637 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cipher Surgical, Ltd.. Cleared Feb 2018. https://www.510kdatabase.net/k171668/ 2018-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k171668-bluetooth-blood-pressure-monitor-fda-510k.jpg K171668 - Bluetooth blood pressure monitor K171668 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Visiomed Group SA. Cleared Feb 2018. https://www.510kdatabase.net/k171797/ 2018-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k171797-tryptik2-c-plate-anterior-cervical-fda-510k.jpg K171797 - TRYPTIK2 C-Plate Anterior Cervical Plate System K171797 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spineart. Cleared Feb 2018. https://www.510kdatabase.net/k172320/ 2018-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k172320-neurostructures-cavetto-cervical-cage-fda-510k.jpg K172320 - Neurostructures Cavetto® Cervical Cage System K172320 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Neurostructures, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k172899/ 2018-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k172899-vygon-piccs-fda-510k.jpg K172899 - Vygon PICCs K172899 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Vygon USA. Cleared Feb 2018. https://www.510kdatabase.net/k180327/ 2018-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k180327-stryker-ivas-13g-bone-biopsy-kit-fda-510k.jpg K180327 - Stryker iVAS 13g Bone Biopsy Kit K180327 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Stryker Corporation. Cleared Feb 2018. https://www.510kdatabase.net/k173643/ 2018-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k173643-trilor-disks-blocks-and-arches-fda-510k.jpg K173643 - Trilor Disks, Blocks and Arches K173643 is a FDA 510(k) cleared dental medical device. Manufacturer: Bioloren S.R.L.. Cleared Feb 2018. https://www.510kdatabase.net/k170540/ 2018-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k170540-dm-density-fda-510k.jpg K170540 - DM-Density K170540 is a FDA 510(k) cleared radiology medical device. Manufacturer: Densitas, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k171601/ 2018-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k171601-ultraxx-nephrostomy-balloon-catheter-fda-510k.jpg K171601 - Ultraxx Nephrostomy Balloon Catheter K171601 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Feb 2018. https://www.510kdatabase.net/k171671/ 2018-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k171671-prismaflex-system-810-fda-510k.jpg K171671 - Prismaflex System 8.10 K171671 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corporation. Cleared Feb 2018. https://www.510kdatabase.net/k171869/ 2018-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k171869-sutter-curis-rf-generator-fda-510k.jpg K171869 - Sutter CURIS RF Generator K171869 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sutter Medizintechnik GmbH. Cleared Feb 2018. https://www.510kdatabase.net/k172324/ 2018-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k172324-axiostat-chitosan-hemostatic-dressing-fda-510k.jpg K172324 - Axiostat Chitosan Hemostatic Dressing K172324 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Advamedica, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k173077/ 2018-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k173077-cavetto-sa-cervical-cage-system-fda-510k.jpg K173077 - Cavetto-SA Cervical Cage System K173077 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Neurostructures, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k173224/ 2018-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k173224-spin-swi-fda-510k.jpg K173224 - SPIN-SWI K173224 is a FDA 510(k) cleared radiology medical device. Manufacturer: Spintech, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k173303/ 2018-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k173303-instant-view-plus-multi-drug-of-abuse-fda-510k.jpg K173303 - INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use) K173303 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Alfa Scientific Designs, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k173320/ 2018-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k173320-kls-martin-l1-mmf-system-fda-510k.jpg K173320 - KLS Martin L1 MMF System K173320 is a FDA 510(k) cleared dental medical device. Manufacturer: KLS-Martin L.P.. Cleared Feb 2018. https://www.510kdatabase.net/k173468/ 2018-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k173468-aquilion-precision-tsx-304a2-v86-with-fda-510k.jpg K173468 - Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0 K173468 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshibamedical Systems Corporation. Cleared Feb 2018. https://www.510kdatabase.net/k173491/ 2018-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k173491-rts-lesser-mtp-implant-system-fda-510k.jpg K173491 - RTS Lesser MTP Implant System K173491 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: In2bones USA, LLC. Cleared Feb 2018. https://www.510kdatabase.net/k173493/ 2018-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k173493-amsco-evolution-floorloader-steam-fda-510k.jpg K173493 - Amsco Evolution Floorloader Steam Sterilizer HC-2000 and HC-3000 K173493 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Feb 2018. https://www.510kdatabase.net/k173569/ 2018-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k173569-ultrasound-system-1300-fda-510k.jpg K173569 - Ultrasound System 1300 K173569 is a FDA 510(k) cleared radiology medical device. Manufacturer: Bk Medical Aps. Cleared Feb 2018. https://www.510kdatabase.net/k173677/ 2018-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k173677-inmode-vlaze-fda-510k.jpg K173677 - InMode VLaze K173677 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Inmode MD , Ltd.. Cleared Feb 2018. https://www.510kdatabase.net/k173689/ 2018-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k173689-ophthalmic-software-platform-rx-fda-510k.jpg K173689 - Ophthalmic Software Platform RX K173689 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Canon Inc. -Medical Equipment Group. Cleared Feb 2018. https://www.510kdatabase.net/k173693/ 2018-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k173693-orbitum-bone-staple-implant-x-and-vi-fda-510k.jpg K173693 - Orbitum Bone Staple Implant, X and VI K173693 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthovestments, LLC. Cleared Feb 2018. https://www.510kdatabase.net/k173863/ 2018-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k173863-ez3d-i-e3-fda-510k.jpg K173863 - Ez3D-i /E3 K173863 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ewoosoft Co., Ltd.. Cleared Feb 2018. https://www.510kdatabase.net/k180130/ 2018-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k180130-eleos-bipolar-acetabular-system-fda-510k.jpg K180130 - ELEOS™ Bipolar Acetabular System K180130 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Onkos Surgical, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k171171/ 2018-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k171171-ks-medicare-powder-free-nitrile-fda-510k.jpg K171171 - KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black) K171171 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Koon Seng Sdn Bhd. Cleared Feb 2018. https://www.510kdatabase.net/k171568/ 2018-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k171568-surfuse-gel-surfuse-putty-exfuse-gel-fda-510k.jpg K171568 - SurFuse Gel, SurFuse Putty, ExFuse Gel, ExFuse Putty K171568 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Hans Biomed Corporation. Cleared Feb 2018. https://www.510kdatabase.net/k171576/ 2018-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k171576-the-panthera-anti-snoring-x3-device-fda-510k.jpg K171576 - The Panthera Anti-Snoring X3 Device K171576 is a FDA 510(k) cleared dental medical device. Manufacturer: Panthera Dental, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k171649/ 2018-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k171649-straumann-cares-m-series-cadcam-system-fda-510k.jpg K171649 - Straumann CARES M-Series CAD/CAM System K171649 is a FDA 510(k) cleared dental medical device. Manufacturer: Institut Straumann AG. Cleared Feb 2018. https://www.510kdatabase.net/k171823/ 2018-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k171823-uu-indicator-tape-and-strip-fda-510k.jpg K171823 - U&U Indicator tape and strip K171823 is a FDA 510(k) cleared general hospital medical device. Manufacturer: U&U Medical Technology Co, Ltd.. Cleared Feb 2018. https://www.510kdatabase.net/k171994/ 2018-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k171994-silicone-peripherally-inserted-central-fda-510k.jpg K171994 - Silicone Peripherally Inserted Central Venous Catheter Set/Tray K171994 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cook Incorporated. Cleared Feb 2018. https://www.510kdatabase.net/k172294/ 2018-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k172294-osteotomy-truss-system-ots-fda-510k.jpg K172294 - Osteotomy Truss System (OTS) K172294 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 4Web, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k172541/ 2018-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k172541-medline-catheter-specimen-collector-fda-510k.jpg K172541 - Medline Catheter Specimen Collector K172541 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medline Industries, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k173067/ 2018-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k173067-lightforce-lts-model-1000-1500-2500-fda-510k.jpg K173067 - LightForce LTS Model 1000, 1500, 2500, and 4000 K173067 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Litecure, LLC. Cleared Feb 2018. https://www.510kdatabase.net/k173236/ 2018-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k173236-sentry-ivc-filter-fda-510k.jpg K173236 - Sentry IVC Filter K173236 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Novate Medical , Ltd.. Cleared Feb 2018. https://www.510kdatabase.net/k173255/ 2018-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k173255-talon-distalfix-humeral-nail-fda-510k.jpg K173255 - Talon DistalFix Humeral Nail K173255 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthopedic Designs North America, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k173334/ 2018-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k173334-seaspine-spinous-process-system-fda-510k.jpg K173334 - SeaSpine Spinous Process System K173334 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared Feb 2018. https://www.510kdatabase.net/k173381/ 2018-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k173381-nexxis-or-fda-510k.jpg K173381 - Nexxis OR K173381 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Barco N.V.. Cleared Feb 2018. https://www.510kdatabase.net/k173402/ 2018-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k173402-neocis-guidance-system-ngs-with-fda-510k.jpg K173402 - Neocis Guidance System (NGS) with Chairside Splint K173402 is a FDA 510(k) cleared dental medical device. Manufacturer: Neocis, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k173485/ 2018-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k173485-amsco-evolution-medium-steam-sterilizer-fda-510k.jpg K173485 - Amsco Evolution Medium Steam Sterilizer K173485 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Feb 2018. https://www.510kdatabase.net/k173490/ 2018-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k173490-amsco-evolution-medium-steam-fda-510k.jpg K173490 - Amsco Evolution Medium Steam Sterilizer (Models HC-800 and HC-1000) K173490 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Feb 2018. https://www.510kdatabase.net/k173967/ 2018-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k173967-remedy-acetabular-cup-fda-510k.jpg K173967 - Remedy Acetabular Cup K173967 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteoremedies, LLC. Cleared Feb 2018. https://www.510kdatabase.net/k180004/ 2018-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k180004-menicon-asrb-asmofilcon-a-silicone-fda-510k.jpg K180004 - Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens K180004 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Menicon Co, Ltd.. Cleared Feb 2018. https://www.510kdatabase.net/k180181/ 2018-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k180181-natus-quantum-fda-510k.jpg K180181 - Natus Quantum K180181 is a FDA 510(k) cleared neurology medical device. Manufacturer: Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). Cleared Feb 2018. https://www.510kdatabase.net/k163377/ 2018-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k163377-captura-disposable-bronchoscope-biopsy-fda-510k.jpg K163377 - Captura Disposable Bronchoscope Biopsy Forceps K163377 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Wilson-Cook Medical, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k170866/ 2018-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k170866-scian-automatic-digital-blood-pressure-fda-510k.jpg K170866 - Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579 K170866 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Honsun (Nantong) Co., Ltd.. Cleared Feb 2018. https://www.510kdatabase.net/k171620/ 2018-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k171620-picco-catheter-fda-510k.jpg K171620 - PiCCO Catheter K171620 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Pulsion Medical Systems SE. Cleared Feb 2018. https://www.510kdatabase.net/k172338/ 2018-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k172338-catasyn-advanced-technology-wound-fda-510k.jpg K172338 - Catasyn Advanced Technology Wound Hydrogel K172338 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Synedgen, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k172647/ 2018-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k172647-reprocessed-arthrocare-ent-coblator-fda-510k.jpg K172647 - Reprocessed ArthroCare ENT Coblator K172647 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Renovo, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k172950/ 2018-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k172950-tsn-transseptal-needle-fda-510k.jpg K172950 - TSN Transseptal Needle K172950 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Pressure Products Medical Device Manufacturing, LLC. Cleared Feb 2018. https://www.510kdatabase.net/k173626/ 2018-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k173626-celerity-20-steam-process-challenge-fda-510k.jpg K173626 - Celerity 20 Steam Process Challenge Device for Dynamic Air Removal Cycles K173626 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Feb 2018. https://www.510kdatabase.net/k173629/ 2018-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k173629-celerity-20-steam-process-challenge-fda-510k.jpg K173629 - CELERITY 20 Steam Process Challenge Device for Gravity Cycles K173629 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Feb 2018. https://www.510kdatabase.net/k173963/ 2018-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k173963-dri-benzodiazepine-assay-fda-510k.jpg K173963 - DRI Benzodiazepine Assay K173963 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Microgenics Corporation. Cleared Feb 2018. https://www.510kdatabase.net/k180193/ 2018-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k180193-deka-smartxide-family-smartxide-touch-fda-510k.jpg K180193 - DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto) K180193 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: El.En Electronic Engineering Spa. Cleared Feb 2018. https://www.510kdatabase.net/k170683/ 2018-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k170683-aesculap-video-assisted-thoracic-fda-510k.jpg K170683 - Aesculap Video Assisted Thoracic Surgery (VATS) INstruments K170683 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k171605/ 2018-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k171605-elecsys-ca-15-3-ii-fda-510k.jpg K171605 - Elecsys CA 15-3 II K171605 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics. Cleared Feb 2018. https://www.510kdatabase.net/k172423/ 2018-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k172423-pediasat-oximetry-catheter-presep-fda-510k.jpg K172423 - PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter) K172423 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifescience, LLC. Cleared Feb 2018. https://www.510kdatabase.net/k172885/ 2018-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k172885-hydropicc-fda-510k.jpg K172885 - HydroPICC K172885 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Access Vascular, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k173228/ 2018-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k173228-u-med-powder-free-polyethylene-fda-510k.jpg K173228 - U-MED Powder Free Polyethylene Examination Gloves,Blue Color K173228 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jiangsu U-Med Rubber & Plastic Products Co., Ltd.. Cleared Feb 2018. https://www.510kdatabase.net/k173270/ 2018-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k173270-tri-staple-20-reinforced-reload-fda-510k.jpg K173270 - Tri-Staple 2.0 Reinforced Reload K173270 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien. Cleared Feb 2018. https://www.510kdatabase.net/k173513/ 2018-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k173513-ws80a-diagnostic-ultrasound-system-fda-510k.jpg K173513 - WS80A Diagnostic Ultrasound System K173513 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Medison Co., Ltd.. Cleared Feb 2018. https://www.510kdatabase.net/k180176/ 2018-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k180176-seaspine-newport-spinal-system-fda-510k.jpg K180176 - SeaSpine NewPort Spinal System K180176 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared Feb 2018. https://www.510kdatabase.net/k172390/ 2018-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k172390-optima-coil-system-fda-510k.jpg K172390 - Optima Coil System K172390 is a FDA 510(k) cleared neurology medical device. Manufacturer: Blockade Medical, LLC (D.B.A. Balt Usa). Cleared Feb 2018. https://www.510kdatabase.net/k171521/ 2018-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k171521-dus-r-50s-urine-chemistry-system-fda-510k.jpg K171521 - DUS R-50S (Urine Chemistry system) K171521 is a FDA 510(k) cleared chemistry medical device. Manufacturer: DFI Co., Ltd.. Cleared Feb 2018. https://www.510kdatabase.net/k171600/ 2018-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k171600-renal-access-cobra-catheter-kumpe-fda-510k.jpg K171600 - Renal Access Cobra Catheter, Kumpe Access Catheter K171600 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Feb 2018. https://www.510kdatabase.net/k171646/ 2018-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k171646-acistcvi-contrast-delivery-system-fda-510k.jpg K171646 - ACISTCVi® Contrast Delivery System K171646 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Acist Medical Systems, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k172208/ 2018-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k172208-nevap-aspire-subglottic-suction-fda-510k.jpg K172208 - NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet K172208 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Nevap, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k172348/ 2018-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k172348-aeskuslides-ndna-crithidia-luciliae-fda-510k.jpg K172348 - AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10 K172348 is a FDA 510(k) cleared immunology medical device. Manufacturer: Aesku.Diagnostics GmbH & Co. KG. Cleared Feb 2018. https://www.510kdatabase.net/k172361/ 2018-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k172361-eea-circular-stapler-with-tri-staple-fda-510k.jpg K172361 - EEA Circular Stapler with Tri-Staple Technology K172361 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien. Cleared Feb 2018. https://www.510kdatabase.net/k172934/ 2018-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k172934-needle-free-transseptal-cannula-fda-510k.jpg K172934 - Needle Free Transseptal Cannula K172934 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Pressure Products Medical Device Manufacturing, LLC. Cleared Feb 2018. https://www.510kdatabase.net/k173409/ 2018-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k173409-wireless-audio-system-fda-510k.jpg K173409 - Wireless Audio System K173409 is a FDA 510(k) cleared radiology medical device. Manufacturer: Neocoil, LLC. Cleared Feb 2018. https://www.510kdatabase.net/k173460/ 2018-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k173460-neuroeeg-fda-510k.jpg K173460 - NeuroEEG K173460 is a FDA 510(k) cleared neurology medical device. Manufacturer: Memory MD, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k173587/ 2018-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k173587-magseed-magnetic-marker-systtem-fda-510k.jpg K173587 - Magseed Magnetic Marker Systtem K173587 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Endomagnetics Ltd.,. Cleared Feb 2018. https://www.510kdatabase.net/k180123/ 2018-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k180123-breast-bi-7-mr-coil-15t-mammavention-fda-510k.jpg K180123 - Breast BI 7 MR Coil 1.5T Mammavention K180123 is a FDA 510(k) cleared radiology medical device. Manufacturer: Noras Mri Products GmbH. Cleared Feb 2018. https://www.510kdatabase.net/k180128/ 2018-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k180128-warrior-14-guidewire-fda-510k.jpg K180128 - Warrior 14 guidewire K180128 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vascular Solutions, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k180141/ 2018-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k180141-spiway-endonasal-access-guide-fda-510k.jpg K180141 - SPIWay Endonasal Access Guide K180141 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Spiway, LLC. Cleared Feb 2018. https://www.510kdatabase.net/k171535/ 2018-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k171535-surgical-isolation-gown-fda-510k.jpg K171535 - SURGICAL ISOLATION GOWN K171535 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Jingzhou Haixin Green Cross Medical Products Co., Ltd.. Cleared Feb 2018. https://www.510kdatabase.net/k171604/ 2018-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k171604-rsch-thurmond-fallopian-tube-fda-510k.jpg K171604 - Rösch Thurmond Fallopian Tube Catheterization Set, Fallopian Tube Catheterization Set, and Fallopian Tube Catheterization Wire Guide with Platinum Tip K171604 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Cook Incorporated. Cleared Feb 2018. https://www.510kdatabase.net/k172613/ 2018-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k172613-optilite-hevylite-igg-kappa-kit-fda-510k.jpg K172613 - Optilite Hevylite IgG Kappa Kit, Optilite Hevylite IgG Lambda Kit K172613 is a FDA 510(k) cleared immunology medical device. Manufacturer: The Binding Site Group , Ltd.. Cleared Feb 2018. https://www.510kdatabase.net/k173212/ 2018-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k173212-instant-view-plus-immunochemical-fecal-fda-510k.jpg K173212 - Instant-view-PLUS immunochemical Fecal Occult Blood Test K173212 is a FDA 510(k) cleared hematology medical device. Manufacturer: Alfa Scientific Designs, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k173288/ 2018-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k173288-corpath-grx-system-fda-510k.jpg K173288 - CorPath GRX System K173288 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Corindus, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k173352/ 2018-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k173352-trevo-pro-vue-retriever-and-trevo-xp-fda-510k.jpg K173352 - Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever) K173352 is a FDA 510(k) cleared neurology medical device. Manufacturer: Concentric Medical, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k173580/ 2018-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k173580-vinyl-patient-examination-glove-yellow-fda-510k.jpg K173580 - Vinyl Patient Examination Glove (Yellow) K173580 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Nature Medical Products Co., Ltd.. Cleared Feb 2018. https://www.510kdatabase.net/k173636/ 2018-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k173636-velocity-fda-510k.jpg K173636 - Velocity K173636 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k173644/ 2018-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k173644-gazelle-polypropylene-suture-and-fda-510k.jpg K173644 - Gazelle Polypropylene Suture and Delivery Device K173644 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Dura Tap, LLC. Cleared Feb 2018. https://www.510kdatabase.net/k173750/ 2018-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k173750-prelude-ideal-hydrophilic-sheath-fda-510k.jpg K173750 - Prelude IDeal Hydrophilic Sheath Introducer K173750 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k173877/ 2018-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k173877-bowa-neutral-electrodes-fda-510k.jpg K173877 - BOWA Neutral Electrodes K173877 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bowa-Electronics GmbH & Co. KG. Cleared Feb 2018. https://www.510kdatabase.net/k180137/ 2018-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k180137-atricure-cryoice-cryo-ablation-probe-fda-510k.jpg K180137 - AtriCure cryoICE cryo-ablation probe (CRYO3), AtriCure cryoICE cryoFORM cryo-ablation probe (CRYOF) K180137 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: AtriCure, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k180138/ 2018-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k180138-atricure-cryoice-cryo-ablation-probe-fda-510k.jpg K180138 - AtriCure cryoICE cryo-ablation probe (CRYO2) K180138 is a FDA 510(k) cleared neurology medical device. Manufacturer: AtriCure, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k172439/ 2018-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k172439-siberian-fit-fda-510k.jpg K172439 - Siberian Fit K172439 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Vydence. Cleared Feb 2018. https://www.510kdatabase.net/k173185/ 2018-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k173185-seurat-universal-pedicle-screw-system-fda-510k.jpg K173185 - SEURAT™ Universal Pedicle Screw System K173185 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ctl Medical Corporation. Cleared Feb 2018. https://www.510kdatabase.net/k173545/ 2018-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k173545-temed-gas-diffuser-fda-510k.jpg K173545 - TEMED Gas Diffuser K173545 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Temed. Cleared Feb 2018. https://www.510kdatabase.net/k173565/ 2018-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k173565-sunrise-6200-sunrise-7200-fda-510k.jpg K173565 - Sunrise 6200, Sunrise 7200 K173565 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Jk Holding GmbH. Cleared Feb 2018. https://www.510kdatabase.net/k173567/ 2018-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k173567-sera-fda-510k.jpg K173567 - Sera K173567 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Interacoustics A/S. Cleared Feb 2018. https://www.510kdatabase.net/k173651/ 2018-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k173651-multiple-tubing-segment-set-with-stay-fda-510k.jpg K173651 - Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain Set K173651 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC. Cleared Feb 2018. https://www.510kdatabase.net/k180158/ 2018-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k180158-surgical-laser-fibers-fda-510k.jpg K180158 - Surgical Laser fibers K180158 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Quanta System Spa. Cleared Feb 2018. https://www.510kdatabase.net/den170045/ 2018-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/den170045-banyan-bti-fda-510k.jpg DEN170045 - Banyan BTI DEN170045 is a FDA 510(k) cleared immunology medical device. Manufacturer: Banyan Biomarkers, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k171825/ 2018-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k171825-disposable-endoscopic-surgical-fda-510k.jpg K171825 - Disposable Endoscopic Surgical Instrument, Reusable Endoscopic Surgical Instrument K171825 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Hunan Handlike Minimally Invasive Surgery Co., Ltd.. Cleared Feb 2018. https://www.510kdatabase.net/k172058/ 2018-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k172058-ct6485-ct12885-fda-510k.jpg K172058 - CT6485, CT12885 K172058 is a FDA 510(k) cleared radiology medical device. Manufacturer: Analogic Corporation. Cleared Feb 2018. https://www.510kdatabase.net/k172624/ 2018-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k172624-voyant-5mm-fusion-device-fda-510k.jpg K172624 - Voyant 5mm Fusion Device K172624 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Applied Medical Resources Corporation. Cleared Feb 2018. https://www.510kdatabase.net/k172839/ 2018-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k172839-endosolv-fda-510k.jpg K172839 - ENDOSOLV K172839 is a FDA 510(k) cleared dental medical device. Manufacturer: Septodont. Cleared Feb 2018. https://www.510kdatabase.net/k172870/ 2018-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k172870-infra-red-ear-thermometer-model-et-fda-510k.jpg K172870 - Infra-red ear thermometer model: ET-100A, ET-100B, ET-100D, ET-100E, ET-100G, ET-100I, ET-100J K172870 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Hangzhou Hua'An Medical&Health Instruments Co.,Ltd. Cleared Feb 2018. https://www.510kdatabase.net/k173195/ 2018-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k173195-dri-hydrocodone-assay-fda-510k.jpg K173195 - DRI Hydrocodone Assay K173195 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Microgenics Corporation. Cleared Feb 2018. https://www.510kdatabase.net/k173313/ 2018-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k173313-supachair-powered-wheelchair-combi-18-fda-510k.jpg K173313 - SupaChair Powered Wheelchair: COMBI 18, COMBI 18SP, COMBI 20, COMBI 20SP K173313 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Eurogreen International, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k173315/ 2018-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k173315-supachair-powered-wheelchair-fda-510k.jpg K173315 - SupaChair Powered Wheelchair K173315 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Eurogreen International, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k173535/ 2018-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k173535-endoskeleton-tas-interbody-fusion-fda-510k.jpg K173535 - Endoskeleton® TAS Interbody Fusion Device, Endoskeleton® TAS Hyperlordotic Interbody Fusion Device and Endoskeleton® TCS Interbody Fusion Device K173535 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Titan Spine, LLC. Cleared Feb 2018. https://www.510kdatabase.net/k173592/ 2018-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k173592-magnetom-aera-magnetom-skyraskyrafit-fda-510k.jpg K173592 - MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM Avantofit K173592 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k180288/ 2018-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k180288-quickvue-influenza-ab-fda-510k.jpg K180288 - QuickVue Influenza A+B K180288 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Quidel Corporation. Cleared Feb 2018. https://www.510kdatabase.net/den170073/ 2018-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/den170073-contact-fda-510k.jpg DEN170073 - ContaCT DEN170073 is a FDA 510(k) cleared radiology medical device. Manufacturer: Viz.Al, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k170793/ 2018-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k170793-surgical-planner-srp-fda-510k.jpg K170793 - SuRgical Planner (SRP) K170793 is a FDA 510(k) cleared radiology medical device. Manufacturer: Surgical Theater, LLC. Cleared Feb 2018. https://www.510kdatabase.net/k171495/ 2018-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k171495-zyston-strut-open-titanium-spacer-system-fda-510k.jpg K171495 - Zyston Strut Open Titanium Spacer System K171495 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer Biomet Spine, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k171933/ 2018-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k171933-asahi-ptca-guide-wires-asahi-corsair-fda-510k.jpg K171933 - ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro Microcatheter K171933 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Asahi Intecc Co., Ltd.. Cleared Feb 2018. https://www.510kdatabase.net/k172775/ 2018-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k172775-minilap-system-with-minigrip-handle-fda-510k.jpg K172775 - MiniLap System with MiniGrip Handle, MiniLap System with ThumbGrip Handle K172775 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Teleflexmedical, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k172883/ 2018-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k172883-home-use-hair-removal-devicet1-t2-t3-fda-510k.jpg K172883 - Home Use Hair Removal Device/T1, T2, T3 K172883 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shenzhen Mareal Tech Co., Ltd.. Cleared Feb 2018. https://www.510kdatabase.net/k172941/ 2018-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k172941-cascadia-interbody-system-fda-510k.jpg K172941 - CASCADIA Interbody System K172941 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: K2m. Cleared Feb 2018. https://www.510kdatabase.net/k173527/ 2018-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k173527-digitex-delivery-device-fda-510k.jpg K173527 - Digitex Delivery Device K173527 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Coloplast A/S. Cleared Feb 2018. https://www.510kdatabase.net/k173561/ 2018-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k173561-vinyl-patient-examination-glove-yellow-fda-510k.jpg K173561 - Vinyl Patient Examination Glove (Yellow) K173561 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Yurun Glove Co., Ltd.. Cleared Feb 2018. https://www.510kdatabase.net/k173579/ 2018-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k173579-thorecon-fixation-system-fda-510k.jpg K173579 - Thorecon™ Fixation System K173579 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: A & E Medical Corporation. Cleared Feb 2018. https://www.510kdatabase.net/k173634/ 2018-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k173634-celerity-20-steam-biological-indicator-fda-510k.jpg K173634 - CELERITY 20 Steam Biological Indicator K173634 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Feb 2018. https://www.510kdatabase.net/k173670/ 2018-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k173670-celerity-20-steam-incubator-fda-510k.jpg K173670 - CELERITY 20 Steam Incubator K173670 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Feb 2018. https://www.510kdatabase.net/k173710/ 2018-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k173710-motoband-cp-implant-system-fda-510k.jpg K173710 - MotoBAND CP Implant System K173710 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Crossroads Extremity Systems, LLC. Cleared Feb 2018. https://www.510kdatabase.net/k180118/ 2018-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k180118-arthrex-nanosuture-anchor-fda-510k.jpg K180118 - Arthrex NanoSuture Anchor K180118 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k180082/ 2018-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k180082-geko-t-2-and-geko-plus-r-2-fda-510k.jpg K180082 - geko T-2 and geko Plus R-2 K180082 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Firstkind, Ltd.. Cleared Feb 2018. https://www.510kdatabase.net/k170131/ 2018-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k170131-tav-medical-dental-implants-system-fda-510k.jpg K170131 - TAV Medical Dental Implants System K170131 is a FDA 510(k) cleared dental medical device. Manufacturer: Tav Medical , Ltd.. Cleared Feb 2018. https://www.510kdatabase.net/k171179/ 2018-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k171179-br-type-implant-system-fda-510k.jpg K171179 - BR Type Implant System K171179 is a FDA 510(k) cleared dental medical device. Manufacturer: Biotem Co., Ltd.. Cleared Feb 2018. https://www.510kdatabase.net/k171455/ 2018-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k171455-at-6xx-series-infrared-thermometer-fda-510k.jpg K171455 - AT-6XX Series Infrared Thermometer K171455 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Xiamen Acurio Instruments Co., Ltd.. Cleared Feb 2018. https://www.510kdatabase.net/k171631/ 2018-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k171631-standard-catheter-set-fda-510k.jpg K171631 - Standard Catheter Set K171631 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k171755/ 2018-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k171755-cs-series-fp-with-mx-cfp-3131-or-mx-fda-510k.jpg K171755 - CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System K171755 is a FDA 510(k) cleared radiology medical device. Manufacturer: Omega Medical Imaging, LLC. Cleared Feb 2018. https://www.510kdatabase.net/k172160/ 2018-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k172160-southern-implants-peek-abutments-fda-510k.jpg K172160 - Southern Implants PEEK Abutments K172160 is a FDA 510(k) cleared dental medical device. Manufacturer: Southern Implants (Pty), Ltd.. Cleared Feb 2018. https://www.510kdatabase.net/k172180/ 2018-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k172180-oscar-15-fda-510k.jpg K172180 - OSCAR 15 K172180 is a FDA 510(k) cleared radiology medical device. Manufacturer: Genoray Co., Ltd.. Cleared Feb 2018. https://www.510kdatabase.net/k172284/ 2018-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k172284-napa-lp-15-airway-pressure-monitor-fda-510k.jpg K172284 - NAPA LP-15 Airway Pressure Monitor K172284 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Drw Medical, LLC. Cleared Feb 2018. https://www.510kdatabase.net/k172422/ 2018-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k172422-kohli-urinary-drainage-catheter-fda-510k.jpg K172422 - Kohli Urinary Drainage Catheter K172422 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Nellie Medical, LLC. Cleared Feb 2018. https://www.510kdatabase.net/k172504/ 2018-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k172504-tosama-biobased-applicator-tube-fda-510k.jpg K172504 - Tosama Biobased Applicator Tube Menstrual Tampon K172504 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Tosama, D.O.O.. Cleared Feb 2018. https://www.510kdatabase.net/k172746/ 2018-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k172746-verify-hpu-chemical-indicator-and-fda-510k.jpg K172746 - VERIFY® HPU Chemical Indicator and VERIFY® Vaporized VH2O2 Process Indicator Adhesive Label K172746 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Feb 2018. https://www.510kdatabase.net/k172748/ 2018-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k172748-verify-v24-self-contained-biological-fda-510k.jpg K172748 - VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack K172748 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Steris Corporations. Cleared Feb 2018. https://www.510kdatabase.net/k172749/ 2018-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k172749-vis-u-all-low-temperature-fda-510k.jpg K172749 - Vis-U-All Low Temperature Sterilization Pouch/Tubing K172749 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Feb 2018. https://www.510kdatabase.net/k172751/ 2018-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k172751-ivitri-straw-fda-510k.jpg K172751 - iVitri Straw K172751 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Reprobitech Corp.. Cleared Feb 2018. https://www.510kdatabase.net/k172752/ 2018-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k172752-celerity-20-hp-biological-indicator-fda-510k.jpg K172752 - CELERITY 20 HP Biological Indicator K172752 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Feb 2018. https://www.510kdatabase.net/k172753/ 2018-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k172753-verify-vh2o2-indicator-tape-fda-510k.jpg K172753 - VERIFY VH2O2 Indicator Tape K172753 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Feb 2018. https://www.510kdatabase.net/k172754/ 2018-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k172754-v-pro-max-2-low-temperature-fda-510k.jpg K172754 - V-PRO maX 2 Low Temperature Sterilization System K172754 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Feb 2018. https://www.510kdatabase.net/k172755/ 2018-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k172755-pro-lite-sterilization-trays-fda-510k.jpg K172755 - PRO-LITE Sterilization Trays K172755 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Feb 2018. https://www.510kdatabase.net/k173163/ 2018-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k173163-chlorcid-chlorcid-v-chlorcid-surf-fda-510k.jpg K173163 - ChlorCid, ChlorCid V, ChlorCid Surf K173163 is a FDA 510(k) cleared dental medical device. Manufacturer: Ultradent Products, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k173272/ 2018-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k173272-ergonomic-handle-fda-510k.jpg K173272 - Ergonomic Handle K173272 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Symmetry Surgical, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k173400/ 2018-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k173400-orise-tissue-retractor-system-fda-510k.jpg K173400 - ORISE Tissue Retractor System K173400 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific. Cleared Feb 2018. https://www.510kdatabase.net/k173435/ 2018-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k173435-3m-attest-rapid-readout-biological-fda-510k.jpg K173435 - 3M Attest Rapid Readout Biological Indicator K173435 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Feb 2018. https://www.510kdatabase.net/k173501/ 2018-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k173501-meridian-vaginal-positioning-system-vps-fda-510k.jpg K173501 - Meridian Vaginal Positioning System (VPS) K173501 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Coloplast. Cleared Feb 2018. https://www.510kdatabase.net/k173523/ 2018-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k173523-bd-phoenix-automated-microbiology-fda-510k.jpg K173523 - BD Phoenix Automated Microbiology System - GN Meropenem-vaborbactam (0.125/8-32/8 ug/mL) K173523 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson and Company. Cleared Feb 2018. https://www.510kdatabase.net/k173791/ 2018-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k173791-leksell-gammaplan-fda-510k.jpg K173791 - Leksell GammaPlan K173791 is a FDA 510(k) cleared radiology medical device. Manufacturer: Elekta Instrument AB. Cleared Feb 2018. https://www.510kdatabase.net/k173823/ 2018-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k173823-amrad-medical-aau-digital-radiography-fda-510k.jpg K173823 - Amrad Medical AAU Digital Radiography System K173823 is a FDA 510(k) cleared radiology medical device. Manufacturer: Summit Industries, LLC. Cleared Feb 2018. https://www.510kdatabase.net/k173894/ 2018-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k173894-jade-pta-balloon-dilatation-catheter-fda-510k.jpg K173894 - Jade PTA Balloon Dilatation Catheter K173894 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Orbusneich Medical Trading, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k180107/ 2018-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k180107-blue-sky-bio-aligner-fda-510k.jpg K180107 - Blue Sky Bio Aligner K180107 is a FDA 510(k) cleared dental medical device. Manufacturer: Blue Sky Bio, LLC. Cleared Feb 2018. https://www.510kdatabase.net/k162727/ 2018-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k162727-senyint-remote-consultation-system-fda-510k.jpg K162727 - SENYINT Remote Consultation System K162727 is a FDA 510(k) cleared radiology medical device. Manufacturer: Dalian Senyint Digital Medical System Co., Ltd.. Cleared Feb 2018. https://www.510kdatabase.net/k173025/ 2018-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k173025-nuvasive-mlx-medial-lateral-expandable-fda-510k.jpg K173025 - NuVasive® MLX® – Medial Lateral Expandable Lumbar Interbody System K173025 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Feb 2018. https://www.510kdatabase.net/k173244/ 2018-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k173244-superdimension-navigation-system-v72-fda-510k.jpg K173244 - superDimension Navigation System V7.2 K173244 is a FDA 510(k) cleared radiology medical device. Manufacturer: Covidien, LLC. Cleared Feb 2018. https://www.510kdatabase.net/k173335/ 2018-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k173335-gazelle-ptfe-and-suture-delivery-device-fda-510k.jpg K173335 - Gazelle PTFE and Suture Delivery Device K173335 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Dura Tap, LLC. Cleared Feb 2018. https://www.510kdatabase.net/k173411/ 2018-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k173411-comprehensive-segmental-revision-fda-510k.jpg K173411 - Comprehensive Segmental Revision System (SRS) K173411 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet Manufacturing Corp. Cleared Feb 2018. https://www.510kdatabase.net/k173537/ 2018-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k173537-concorde-lift-fda-510k.jpg K173537 - CONCORDE LIFT™ K173537 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International SARL. Cleared Feb 2018. https://www.510kdatabase.net/k173553/ 2018-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k173553-lucas-3-chest-compression-system-fda-510k.jpg K173553 - LUCAS 3 Chest Compression System K173553 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Jolife AB. Cleared Feb 2018. https://www.510kdatabase.net/k173805/ 2018-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k173805-nexsite-hd-hemodialysis-symmetric-tip-fda-510k.jpg K173805 - NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (19cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (23cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (27cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (31cm),NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (35cm), NexSite HD Hemodialysis Symmetric Tip Catheter for long term use (55cm) K173805 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Marvao Medical Devices, Ltd.. Cleared Feb 2018. https://www.510kdatabase.net/k180084/ 2018-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k180084-ultrasound-system-sonimage-mx1-fda-510k.jpg K180084 - Ultrasound System SONIMAGE MX1 K180084 is a FDA 510(k) cleared radiology medical device. Manufacturer: Konica Minolta, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k180091/ 2018-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k180091-unid-spine-analyzer-fda-510k.jpg K180091 - UNiD Spine Analyzer K180091 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medicrea International. Cleared Feb 2018. https://www.510kdatabase.net/k161222/ 2018-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k161222-pentax-medical-ed-3490tk-video-fda-510k.jpg K161222 - PENTAX MEDICAL ED-3490TK, Video Duodenoscope K161222 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Pentax Medical. Cleared Feb 2018. https://www.510kdatabase.net/k171520/ 2018-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k171520-sterizign-signatur-device-protection-fda-510k.jpg K171520 - SteriZign Signatur Device Protection System K171520 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sterizign Precision Technologies, LLC. Cleared Feb 2018. https://www.510kdatabase.net/k171861/ 2018-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k171861-capillarys-hb-a1c-fda-510k.jpg K171861 - CAPILLARYS Hb A1c K171861 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sebia. Cleared Feb 2018. https://www.510kdatabase.net/k172698/ 2018-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k172698-g-beam-fusion-beaming-system-fda-510k.jpg K172698 - G-Beam Fusion Beaming System K172698 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthofix Srl. Cleared Feb 2018. https://www.510kdatabase.net/k173199/ 2018-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k173199-picosure-workstation-fda-510k.jpg K173199 - PicoSure Workstation K173199 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cynosure, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k173450/ 2018-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k173450-press-duo-elite-press-duo-elite-ag-fda-510k.jpg K173450 - PRESS DUO elite, PRESS DUO elite AG K173450 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nemoto Kyorindo Co., Ltd.. Cleared Feb 2018. https://www.510kdatabase.net/k173826/ 2018-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k173826-thp-hip-fracture-plating-system-fda-510k.jpg K173826 - THP Hip Fracture Plating System K173826 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k180067/ 2018-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k180067-acuson-x800-diagnostic-ultrasound-system-fda-510k.jpg K180067 - ACUSON X800 Diagnostic Ultrasound System K180067 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k171375/ 2018-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k171375-gammex-pi-breach-detect-powder-free-fda-510k.jpg K171375 - Gammex PI Breach Detect Powder Free Surgical Glove K171375 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ansell Healthcare Products, LLC. Cleared Feb 2018. https://www.510kdatabase.net/k171557/ 2018-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k171557-acqref-introducer-sheath-fda-510k.jpg K171557 - AcQRef Introducer Sheath K171557 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Acutus Medical, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k171641/ 2018-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k171641-accula-flu-aflu-b-test-fda-510k.jpg K171641 - Accula Flu A/Flu B Test K171641 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Mesa Biotech, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k172490/ 2018-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k172490-eunity-fda-510k.jpg K172490 - eUnity K172490 is a FDA 510(k) cleared radiology medical device. Manufacturer: Client Outlook, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k172832/ 2018-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k172832-insight-bd-fda-510k.jpg K172832 - Insight BD K172832 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medi Cal Solutions, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k172953/ 2018-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k172953-acid-etchant-fda-510k.jpg K172953 - Acid Etchant K172953 is a FDA 510(k) cleared dental medical device. Manufacturer: American Orthodontics. Cleared Feb 2018. https://www.510kdatabase.net/k173528/ 2018-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k173528-devon-24r-deep-vein-thrombosis-dvt-fda-510k.jpg K173528 - Devon 24R Deep Vein Thrombosis (DVT) Prevention Therapy System K173528 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Devon Medical Products (Jiangsu), Ltd.. Cleared Feb 2018. https://www.510kdatabase.net/k173882/ 2018-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k173882-seaspine-mariner-pedicle-screw-system-fda-510k.jpg K173882 - SeaSpine Mariner Pedicle Screw System K173882 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared Feb 2018. https://www.510kdatabase.net/k171208/ 2018-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k171208-trans-anal-introducer-fda-510k.jpg K171208 - Trans-anal Introducer K171208 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Visionsense, Ltd.. Cleared Feb 2018. https://www.510kdatabase.net/k171361/ 2018-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k171361-bettercare-platform-advanced-web-client-fda-510k.jpg K171361 - BETTERCARE PLATFORM - ADVANCED WEB CLIENT K171361 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Better Care, S.L.. Cleared Feb 2018. https://www.510kdatabase.net/k171516/ 2018-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k171516-flip-lube-fda-510k.jpg K171516 - Flip Lube K171516 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Imquest Biosciences, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k171695/ 2018-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k171695-first-sign-multi-drug-dip-card-test-fda-510k.jpg K171695 - First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign Drug of Abuse Dip Card Test Marijuana, First Sign Drug of Abuse Cup Test Marijuana K171695 is a FDA 510(k) cleared toxicology medical device. Manufacturer: W.H.P.M., Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k172040/ 2018-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k172040-aquilex-fluid-control-system-aql-100s-fda-510k.jpg K172040 - Aquilex Fluid Control System AQL-100S K172040 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: W.O.M. World of Medicine GmbH. Cleared Feb 2018. https://www.510kdatabase.net/k173204/ 2018-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k173204-rs85-diagnostic-ultrasound-system-fda-510k.jpg K173204 - RS85 Diagnostic Ultrasound System K173204 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Medison Co., Ltd.. Cleared Feb 2018. https://www.510kdatabase.net/k173433/ 2018-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k173433-proxidiagnost-n90-fda-510k.jpg K173433 - ProxiDiagnost N90 K173433 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Dmc GmbH. Cleared Feb 2018. https://www.510kdatabase.net/k173512/ 2018-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k173512-mfi-cardiac-fda-510k.jpg K173512 - MFI-Cardiac K173512 is a FDA 510(k) cleared radiology medical device. Manufacturer: Multifunctional Imaging, LLC. Cleared Feb 2018. https://www.510kdatabase.net/k173672/ 2018-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k173672-flowtriever-retrievalaspiration-system-fda-510k.jpg K173672 - FlowTriever Retrieval/Aspiration System, Aspiration Guide Catheter K173672 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inari Medical. Cleared Feb 2018. https://www.510kdatabase.net/k173924/ 2018-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k173924-drx-revolution-nano-mobile-x-ray-system-fda-510k.jpg K173924 - DRX-Revolution Nano Mobile X-ray System K173924 is a FDA 510(k) cleared radiology medical device. Manufacturer: Carestream Health, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k170112/ 2018-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k170112-imds-lumbar-puncture-needle-fda-510k.jpg K170112 - IMD's Lumbar Puncture Needle K170112 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: International Medical Development, Inc.(Imd). Cleared Feb 2018. https://www.510kdatabase.net/k171402/ 2018-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k171402-karl-storz-slim-nasopharyngolaryngoscope-fda-510k.jpg K171402 - KARL STORZ Slim Nasopharyngolaryngoscope K171402 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k171403/ 2018-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k171403-oraltox-oral-fluid-drug-test-fda-510k.jpg K171403 - OralTox Oral Fluid Drug Test K171403 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Premier Biotech, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k171450/ 2018-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k171450-glooko-mobile-insulin-dosing-system-fda-510k.jpg K171450 - Glooko Mobile Insulin Dosing System K171450 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Glooko, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k172005/ 2018-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k172005-pico-7-single-use-negative-pressure-fda-510k.jpg K172005 - PICO 7 Single Use Negative Pressure Wound Therapy System K172005 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew Medical Limited. Cleared Feb 2018. https://www.510kdatabase.net/k172105/ 2018-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k172105-the-plateau-lo-spacer-system-fda-510k.jpg K172105 - The Plateau-LO Spacer System K172105 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k172237/ 2018-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k172237-bicera-resorbable-bone-substitute-fda-510k.jpg K172237 - Bicera Resorbable Bone Substitute K172237 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wiltrom Corporation Limited. Cleared Feb 2018. https://www.510kdatabase.net/k172512/ 2018-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k172512-acro-hcg-pregnancy-rapid-test-fda-510k.jpg K172512 - ACRO HCG Pregnancy Rapid Test K172512 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Acro Biotech, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k173445/ 2018-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k173445-materialise-tka-guide-system-fda-510k.jpg K173445 - Materialise TKA Guide System K173445 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Materialise NV. Cleared Feb 2018. https://www.510kdatabase.net/k173800/ 2018-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k173800-camber-spine-technologies-spira-v-open-fda-510k.jpg K173800 - Camber Spine Technologies SPIRA - V™ Open Matrix Corpectomy Cage K173800 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Camber Spine Technologies. Cleared Feb 2018. https://www.510kdatabase.net/k173849/ 2018-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k173849-triathlon-total-knee-system-fda-510k.jpg K173849 - Triathlon Total Knee System K173849 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Orthopaedics. Cleared Feb 2018. https://www.510kdatabase.net/k173981/ 2018-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k173981-acuson-nx2-diagnostic-ultrasound-fda-510k.jpg K173981 - ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System K173981 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc. Ultrasound Group. Cleared Feb 2018. https://www.510kdatabase.net/k180036/ 2018-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k180036-smaxel-co2-surgical-laser-system-fda-510k.jpg K180036 - SMAXEL CO2 Surgical Laser System K180036 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ids, Ltd.. Cleared Feb 2018. https://www.510kdatabase.net/k180070/ 2018-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k180070-speedicath-flex-coude-pro-fda-510k.jpg K180070 - SpeediCath Flex Coude Pro K180070 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Coloplast. Cleared Feb 2018. https://www.510kdatabase.net/k161989/ 2018-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k161989-premium-implant-systems-shelta-implant-fda-510k.jpg K161989 - PREMIUM Implant Systems SHELTA Implant Systems K161989 is a FDA 510(k) cleared dental medical device. Manufacturer: Sweden & Martina S.P.A.. Cleared Feb 2018. https://www.510kdatabase.net/k171287/ 2018-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k171287-sporview-vh202-bi-fda-510k.jpg K171287 - Sporview VH202 BI K171287 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Spsmedical Supply Corp. A Division of Cantel Medical. Cleared Feb 2018. https://www.510kdatabase.net/k171384/ 2018-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k171384-micromed-brain-quick-system-fda-510k.jpg K171384 - Micromed BRAIN QUICK system K171384 is a FDA 510(k) cleared neurology medical device. Manufacturer: Micromed S.P.A.. Cleared Feb 2018. https://www.510kdatabase.net/k171629/ 2018-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k171629-abccolla-bone-graft-fda-510k.jpg K171629 - ABCcolla Bone Graft K171629 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Acro Biomedical Co., Ltd.. Cleared Feb 2018. https://www.510kdatabase.net/k171662/ 2018-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k171662-open-end-ureteral-catheter-open-end-fda-510k.jpg K171662 - Open-End Ureteral Catheter, Open-End Ureteral Catheter Sof-Flex, EchoTip Open-End Ureteral Catheter, Open-End Flexi-Tip Ureteral Catheter, Flexi-Tip Ureteral Catheter (Closed End), Whistle Tip Ureteral Catheter, Round Tip Ureteral Catheter, Spiral Tip Ureteral Access Catheter, Pediatric Ureteral Catheter K171662 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Feb 2018. https://www.510kdatabase.net/k172146/ 2018-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k172146-meristeel-fda-510k.jpg K172146 - MERISTEEL K172146 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: M/s. Meril Endo Surgery Private Limited.. Cleared Feb 2018. https://www.510kdatabase.net/k172395/ 2018-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k172395-duatene-bilayer-mesh-fda-510k.jpg K172395 - Duatene bilayer mesh K172395 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sofradim Production. Cleared Feb 2018. https://www.510kdatabase.net/k172509/ 2018-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k172509-sentosa-sa201-hsv-12-qualitative-pcr-fda-510k.jpg K172509 - Sentosa SA201 HSV 1/2 Qualitative PCR Test K172509 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Vela Diagnostics USA, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k172789/ 2018-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k172789-specimen-retrieval-bag-fda-510k.jpg K172789 - Specimen Retrieval Bag K172789 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Beijing Hangtian Kadi Technology R&D Institute. Cleared Feb 2018. https://www.510kdatabase.net/k172828/ 2018-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k172828-double-medical-cage-system-fda-510k.jpg K172828 - Double Medical Cage System K172828 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Double Medical Technology, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k173047/ 2018-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k173047-the-solstice-oct-system-fda-510k.jpg K173047 - The Solstice OCT System K173047 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k173443/ 2018-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k173443-aeon-endoscopic-stapler-fda-510k.jpg K173443 - AEON Endoscopic Stapler K173443 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Lexington Medical, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k173957/ 2018-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k173957-acuson-nx3-diagnostic-ultrasound-system-fda-510k.jpg K173957 - ACUSON NX3 Diagnostic Ultrasound System K173957 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k180039/ 2018-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k180039-acuson-p600-diagnostic-ultrasound-system-fda-510k.jpg K180039 - ACUSON P600 Diagnostic Ultrasound System K180039 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 2018. https://www.510kdatabase.net/k171297/ 2018-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k171297-arn-type-implant-system-fda-510k.jpg K171297 - AR_N Type Implant System K171297 is a FDA 510(k) cleared dental medical device. Manufacturer: Biotem Co., Ltd.. Cleared Jan 2018. https://www.510kdatabase.net/k171396/ 2018-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k171396-odfs-pace-xl-fda-510k.jpg K171396 - ODFS Pace XL K171396 is a FDA 510(k) cleared neurology medical device. Manufacturer: Odstock Medical, Ltd.. Cleared Jan 2018. https://www.510kdatabase.net/k171772/ 2018-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k171772-ecosite-bulk-fill-fda-510k.jpg K171772 - Ecosite Bulk Fill K171772 is a FDA 510(k) cleared dental medical device. Manufacturer: Dmg USA, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k172240/ 2018-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k172240-spi-dental-implant-system-fda-510k.jpg K172240 - SPI Dental Implant System K172240 is a FDA 510(k) cleared dental medical device. Manufacturer: Msi France. Cleared Jan 2018. https://www.510kdatabase.net/k172567/ 2018-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k172567-gore-molding-and-occlusion-balloon-fda-510k.jpg K172567 - GORE Molding and Occlusion Balloon Catheter K172567 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W. L. Gore and Associates, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k172643/ 2018-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k172643-da-vinci-xi-surgical-system-fda-510k.jpg K172643 - da Vinci Xi Surgical System K172643 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k172845/ 2018-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k172845-symetri-clear-fda-510k.jpg K172845 - Symetri Clear K172845 is a FDA 510(k) cleared dental medical device. Manufacturer: Ormco Corporation. Cleared Jan 2018. https://www.510kdatabase.net/k173088/ 2018-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k173088-vitrea-software-toshiba-package-vstp-fda-510k.jpg K173088 - Vitrea Software Toshiba Package VSTP-001A K173088 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshibamedical Systems Corporation. Cleared Jan 2018. https://www.510kdatabase.net/k173530/ 2018-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k173530-indegor-fda-510k.jpg K173530 - Indego(R) K173530 is a FDA 510(k) cleared neurology medical device. Manufacturer: Parker Hannifin Corporation. Cleared Jan 2018. https://www.510kdatabase.net/k173601/ 2018-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k173601-merit-syringe-fda-510k.jpg K173601 - Merit Syringe K173601 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k180010/ 2018-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k180010-atriclip-flex-v-fda-510k.jpg K180010 - AtriClip FLEX-V K180010 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: AtriCure, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k170438/ 2018-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k170438-mirocam-capsule-endoscope-system-fda-510k.jpg K170438 - MiroCam Capsule Endoscope System K170438 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Intromedic Co., Ltd.. Cleared Jan 2018. https://www.510kdatabase.net/k171500/ 2018-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k171500-uro-v-cystoscope-fda-510k.jpg K171500 - Uro-V Cystoscope K171500 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Uroviu Corporation. Cleared Jan 2018. https://www.510kdatabase.net/k171835/ 2018-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k171835-irradiation-aesthetic-device-fda-510k.jpg K171835 - Irradiation Aesthetic Device K171835 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Chongqing Peninsula Medical Technology Co., Ltd.. Cleared Jan 2018. https://www.510kdatabase.net/k172159/ 2018-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k172159-getinge-gss67n-series-steam-sterilizer-fda-510k.jpg K172159 - Getinge GSS67N Series Steam Sterilizer K172159 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Maquet GmbH. Cleared Jan 2018. https://www.510kdatabase.net/k173389/ 2018-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k173389-rex-medical-aspiration-pump-fda-510k.jpg K173389 - Rex Medical Aspiration Pump K173389 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Rex Medical, L.P.. Cleared Jan 2018. https://www.510kdatabase.net/k173417/ 2018-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k173417-zimmer-persona-personalized-knee-system-fda-510k.jpg K173417 - Zimmer Persona Personalized Knee System K173417 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k173436/ 2018-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k173436-luma-light-system-fda-510k.jpg K173436 - Luma Light System K173436 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Luma Therapeutics. Cleared Jan 2018. https://www.510kdatabase.net/k163081/ 2018-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k163081-40-42mm-bipolar-head-and-22mm-femoral-fda-510k.jpg K163081 - 40-42mm BiPolar Head and 22mm Femoral Head K163081 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Signature Orthopaedics Pty, Ltd.. Cleared Jan 2018. https://www.510kdatabase.net/k173285/ 2018-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k173285-joule-system-fda-510k.jpg K173285 - JOULE SYSTEM K173285 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sciton, Inc. Cleared Jan 2018. https://www.510kdatabase.net/k173596/ 2018-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k173596-rusch-intermittent-urethral-catheters-fda-510k.jpg K173596 - Rusch Intermittent Urethral Catheters K173596 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Teleflex Medical. Cleared Jan 2018. https://www.510kdatabase.net/k173814/ 2018-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k173814-degen-medical-e3-mis-pedicle-screw-fda-510k.jpg K173814 - DeGen Medical E3 MIS Pedicle Screw System K173814 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Degen Medical. Cleared Jan 2018. https://www.510kdatabase.net/k162665/ 2018-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k162665-micor-a100-wearable-ecg-recorder-fda-510k.jpg K162665 - MiCor A100 Wearable ECG Recorder K162665 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Mitac International Corp.. Cleared Jan 2018. https://www.510kdatabase.net/k171367/ 2018-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k171367-sancare-sterile-latex-examination-fda-510k.jpg K171367 - SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES) K171367 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sanrea Healthcare Products Pvt, Ltd.. Cleared Jan 2018. https://www.510kdatabase.net/k171391/ 2018-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k171391-stryker-90-s-max-serfas-energy-probe-fda-510k.jpg K171391 - Stryker 90-S Max SERFAS Energy Probe K171391 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker. Cleared Jan 2018. https://www.510kdatabase.net/k172716/ 2018-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k172716-v2k-rinspiration-system-fda-510k.jpg K172716 - V2K Rinspiration System K172716 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: V2k Medical, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k172816/ 2018-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k172816-tiger-shark-system-fda-510k.jpg K172816 - TiGer Shark™ System K172816 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Choicespine, LP. Cleared Jan 2018. https://www.510kdatabase.net/k172890/ 2018-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k172890-sedline-sedation-monitor-fda-510k.jpg K172890 - SedLine Sedation Monitor K172890 is a FDA 510(k) cleared neurology medical device. Manufacturer: Masimo Corporation. Cleared Jan 2018. https://www.510kdatabase.net/k172896/ 2018-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k172896-arm-type-automatic-blood-pressure-fda-510k.jpg K172896 - Arm Type Automatic Blood Pressure Monitor BP310A, BP313A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, BP-JC312 K172896 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Jiacom Technology CO ., Ltd.. Cleared Jan 2018. https://www.510kdatabase.net/k172935/ 2018-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k172935-embrace-fda-510k.jpg K172935 - Embrace K172935 is a FDA 510(k) cleared neurology medical device. Manufacturer: Empatica S.R.L.. Cleared Jan 2018. https://www.510kdatabase.net/k172969/ 2018-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k172969-essence-55s-large-monitor-system-fda-510k.jpg K172969 - Essence 55S Large Monitor System K172969 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenyang Torch-Bigtide Digital Technology Co., Ltd.. Cleared Jan 2018. https://www.510kdatabase.net/k173299/ 2018-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k173299-dragon-x-spsl4hc-dragon-x-spsl8hc-fda-510k.jpg K173299 - DRAGON X SPSL4HC, DRAGON X SPSL8HC K173299 is a FDA 510(k) cleared radiology medical device. Manufacturer: Sedecal., Sa.. Cleared Jan 2018. https://www.510kdatabase.net/k173382/ 2018-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k173382-vantage-galan-3t-v46-fda-510k.jpg K173382 - Vantage Galan 3T, V4.6 K173382 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshibamedical Systems Corporation. Cleared Jan 2018. https://www.510kdatabase.net/k173430/ 2018-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k173430-sequre-nf-and-sequre-microcatheters-fda-510k.jpg K173430 - SeQure® NF and SeQure® Microcatheters K173430 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Accurate Medical Therapeutics, Ltd.. Cleared Jan 2018. https://www.510kdatabase.net/k173466/ 2018-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k173466-panthera-dental-milled-bars-fda-510k.jpg K173466 - Panthera Dental Milled Bars K173466 is a FDA 510(k) cleared dental medical device. Manufacturer: Panthera Dental, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k173558/ 2018-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k173558-symri-fda-510k.jpg K173558 - SyMRI K173558 is a FDA 510(k) cleared radiology medical device. Manufacturer: Syntheticmr AB. Cleared Jan 2018. https://www.510kdatabase.net/k173709/ 2018-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k173709-zenith-support-95-cm-zenith-support-fda-510k.jpg K173709 - Zenith Support, 95 cm, Zenith Support, 105 cm, Zenith Support, 115 cm K173709 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Inneuroco, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k173843/ 2018-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k173843-illumiflow-148-laser-cap-fda-510k.jpg K173843 - illumiflow 148 Laser Cap K173843 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Eglobal, LLC. Cleared Jan 2018. https://www.510kdatabase.net/k173932/ 2018-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k173932-alere-i-influenza-a-b-alere-i-strep-a-fda-510k.jpg K173932 - Alere i Influenza A & B, Alere i Strep A, Alere i RSV, Alere i Influenza A & B 2 K173932 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Alere Scarborough, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k173953/ 2018-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k173953-udr-780i-fda-510k.jpg K173953 - uDR 780i K173953 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shanghai United Imaging Healthcare Co., Ltd.. Cleared Jan 2018. https://www.510kdatabase.net/k173955/ 2018-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k173955-mic-key-sf-over-the-wire-stoma-fda-510k.jpg K173955 - Mic-Key* SF Over-the-Wire Stoma Measuring Device K173955 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Halyard Health, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k171264/ 2018-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k171264-royal-flush-catheter-fda-510k.jpg K171264 - Royal Flush Catheter K171264 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Jan 2018. https://www.510kdatabase.net/k171954/ 2018-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k171954-clearline-iv-fda-510k.jpg K171954 - ClearLine IV K171954 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Clearline MD. Cleared Jan 2018. https://www.510kdatabase.net/k171968/ 2018-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k171968-echoglo-needle-fda-510k.jpg K171968 - EchoGlo Needle K171968 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Smiths Medical Asd, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k171971/ 2018-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k171971-comprehensive-metabolic-panel-skyla-fda-510k.jpg K171971 - Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer K171971 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Lite-On Technology Corp. H.S.P.B.. Cleared Jan 2018. https://www.510kdatabase.net/k172116/ 2018-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k172116-stryker-ivas-elite-inflatable-fda-510k.jpg K172116 - Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter) K172116 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Corporation. Cleared Jan 2018. https://www.510kdatabase.net/k173060/ 2018-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k173060-fp-nivairotm-rt046-non-vented-hospital-fda-510k.jpg K173060 - F&P NivairoTM RT046 Non-Vented Hospital Full Face Mask, Standard Elbow Version K173060 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Fisher and Paykel Healthcare Limited. Cleared Jan 2018. https://www.510kdatabase.net/k173062/ 2018-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k173062-non-woven-face-mask-models-vqn0185w-fda-510k.jpg K173062 - Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties)) K173062 is a FDA 510(k) cleared general hospital medical device. Manufacturer: V&Q Manufacturing Corporation. Cleared Jan 2018. https://www.510kdatabase.net/k173448/ 2018-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k173448-clinicloud-stethoscope-fda-510k.jpg K173448 - CliniCloud Stethoscope K173448 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Stethocloud Pty.Ltd (Clinicloud). Cleared Jan 2018. https://www.510kdatabase.net/k173542/ 2018-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k173542-arterys-oncology-dl-fda-510k.jpg K173542 - Arterys Oncology DL K173542 is a FDA 510(k) cleared radiology medical device. Manufacturer: Arterys, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k173581/ 2018-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k173581-gallant-ptca-dilatation-catheter-fda-510k.jpg K173581 - Gallant PTCA Dilatation Catheter K173581 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medinol, Ltd.. Cleared Jan 2018. https://www.510kdatabase.net/k171528/ 2018-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k171528-bladder-scanner-model-padscan-ds3-fda-510k.jpg K171528 - Bladder Scanner (model: PadScan DS3, PadScan Z3, PadScan Z5) K171528 is a FDA 510(k) cleared radiology medical device. Manufacturer: Avantsonic Technology Co., Ltd.. Cleared Jan 2018. https://www.510kdatabase.net/k171942/ 2018-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k171942-electrocardiograph-fda-510k.jpg K171942 - Electrocardiograph K171942 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edan Instruments, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k173196/ 2018-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k173196-suntouch-dental-dressing-fda-510k.jpg K173196 - SUNTOUCH Dental Dressing K173196 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Huizhou Foryou Medical Devices Co., Ltd.. Cleared Jan 2018. https://www.510kdatabase.net/k173363/ 2018-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k173363-cycler-drain-bag-set-fda-510k.jpg K173363 - Cycler Drain Bag Set K173363 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fresenius Medical Care Renal Therapies Group, LLC. Cleared Jan 2018. https://www.510kdatabase.net/k173521/ 2018-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k173521-seaspine-cabo-acp-anterior-cervical-fda-510k.jpg K173521 - SeaSpine Cabo ACP (Anterior Cervical Plate) System K173521 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: SeaSpine Orthopedics Corporation. Cleared Jan 2018. https://www.510kdatabase.net/k173876/ 2018-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k173876-cybird-led-curing-light-fda-510k.jpg K173876 - Cybird LED Curing Light K173876 is a FDA 510(k) cleared dental medical device. Manufacturer: Dxm Co., Ltd.. Cleared Jan 2018. https://www.510kdatabase.net/k163684/ 2018-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k163684-c2-cryoballoon-ablation-system-fda-510k.jpg K163684 - C2 CryoBalloon Ablation System K163684 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C2 Therapeutics, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k171789/ 2018-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k171789-arrow-reverse-porous-glenoid-fda-510k.jpg K171789 - ARROW Reverse Porous Glenoid K171789 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Fournitures Hospitalieres Industrie. Cleared Jan 2018. https://www.510kdatabase.net/k172304/ 2018-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k172304-truabutment-ds-fda-510k.jpg K172304 - TruAbutment DS K172304 is a FDA 510(k) cleared dental medical device. Manufacturer: Truabutment, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k173442/ 2018-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k173442-gammacore-s-fda-510k.jpg K173442 - gammaCore-S K173442 is a FDA 510(k) cleared neurology medical device. Manufacturer: Electrocore, LLC. Cleared Jan 2018. https://www.510kdatabase.net/k163600/ 2018-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k163600-kit-boxes-and-kit-plates-fda-510k.jpg K163600 - Kit Boxes and Kit Plates K163600 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Nobel Biocare AB. Cleared Jan 2018. https://www.510kdatabase.net/k171312/ 2018-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k171312-forticore-fda-510k.jpg K171312 - FortiCore® K171312 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nanovis, LLC. Cleared Jan 2018. https://www.510kdatabase.net/k171360/ 2018-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k171360-contec-electrocardiograph-fda-510k.jpg K171360 - CONTEC™ Electrocardiograph K171360 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Contec Medical Systems Co.,Ltd. Cleared Jan 2018. https://www.510kdatabase.net/k172920/ 2018-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k172920-3d-apt-fda-510k.jpg K172920 - 3D APT K172920 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Jan 2018. https://www.510kdatabase.net/k173217/ 2018-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k173217-campylobacter-quik-chek-fda-510k.jpg K173217 - CAMPYLOBACTER QUIK CHEK K173217 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Techlab, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k173219/ 2018-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k173219-campylobacter-chek-fda-510k.jpg K173219 - CAMPYLOBACTER CHEK K173219 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Techlab, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k173235/ 2018-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k173235-aristotle-14-guidewire-200cm-soft-fda-510k.jpg K173235 - Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300cm, Soft Profile, Aristotle 14 Guidewire, 300cm, Support Profile K173235 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Scientia Vascular, LLC. Cleared Jan 2018. https://www.510kdatabase.net/k173306/ 2018-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k173306-ez-plate-fda-510k.jpg K173306 - EZ Plate K173306 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zavation Medical Products, LLC. Cleared Jan 2018. https://www.510kdatabase.net/k173584/ 2018-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k173584-3m-attest-super-rapid-readout-fda-510k.jpg K173584 - 3M Attest Super Rapid Readout Biological Indicator, 3M Attest Auto-reader, 3M Attest Auto-reader K173584 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Jan 2018. https://www.510kdatabase.net/k180025/ 2018-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k180025-centurion-poct-system-fda-510k.jpg K180025 - Centurion POCT System K180025 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthofix, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k171228/ 2018-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k171228-fiji-anchor-fda-510k.jpg K171228 - Fiji Anchor K171228 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Sportwelding GmbH. Cleared Jan 2018. https://www.510kdatabase.net/k171273/ 2018-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k171273-link-bimobiletm-dual-mobility-system-fda-510k.jpg K171273 - LINK® BiMobile(TM) Dual Mobility System K171273 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Waldemar Link GmbH & Co. KG. Cleared Jan 2018. https://www.510kdatabase.net/k171291/ 2018-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k171291-fujifilm-bronchoscope-model-eb-530p-fda-510k.jpg K171291 - FUJIFILM Bronchoscope Model EB-530P K171291 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Fujifilm Medical Systems U.S.A, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k171313/ 2018-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k171313-em-4000-specular-microscope-fda-510k.jpg K171313 - EM-4000 Specular Microscope K171313 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Tomey Corporation. Cleared Jan 2018. https://www.510kdatabase.net/k171673/ 2018-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k171673-focus-cap-fda-510k.jpg K171673 - Focus Cap K171673 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Gce Medical Corporation. Cleared Jan 2018. https://www.510kdatabase.net/k171674/ 2018-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k171674-angel-align-system-fda-510k.jpg K171674 - Angel Align System K171674 is a FDA 510(k) cleared dental medical device. Manufacturer: Smile Development Corp. Cleared Jan 2018. https://www.510kdatabase.net/k171731/ 2018-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k171731-kronus-ia-2-autoantibody-ia-2ab-elisa-fda-510k.jpg K171731 - KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit K171731 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Kronus, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k171784/ 2018-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k171784-straumann-dental-implant-system-fda-510k.jpg K171784 - Straumann Dental Implant System K171784 is a FDA 510(k) cleared dental medical device. Manufacturer: Straumann USA, LLC. Cleared Jan 2018. https://www.510kdatabase.net/k171827/ 2018-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k171827-reddyport-niv-access-elbow-fda-510k.jpg K171827 - ReddyPort NIV Access Elbow K171827 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Smd Manufacturing, LLC. Cleared Jan 2018. https://www.510kdatabase.net/k172696/ 2018-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k172696-forza-xp-expandable-spacer-system-fda-510k.jpg K172696 - FORZA® XP Expandable Spacer System K172696 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthofix, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k173119/ 2018-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k173119-dri-oct-triton-fda-510k.jpg K173119 - DRI OCT Triton K173119 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Topcon Corporation. Cleared Jan 2018. https://www.510kdatabase.net/k173215/ 2018-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k173215-choice-spine-laminoplasty-fixation-fda-510k.jpg K173215 - Choice Spine Laminoplasty™ Fixation System K173215 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Choicespine, LP. Cleared Jan 2018. https://www.510kdatabase.net/k173283/ 2018-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k173283-reliance-lumbar-ibf-system-fda-510k.jpg K173283 - Reliance Lumbar IBF System K173283 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Reliance Medical Systems, LLC. Cleared Jan 2018. https://www.510kdatabase.net/k173301/ 2018-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k173301-biosphere-mis-putty-biosphere-mis-fda-510k.jpg K173301 - BioSphere MIS Putty (BioSphere MIS) K173301 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synergy Biomedical, LLC. Cleared Jan 2018. https://www.510kdatabase.net/k173478/ 2018-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k173478-onsight-3d-extremity-system-fda-510k.jpg K173478 - OnSight 3D Extremity System K173478 is a FDA 510(k) cleared radiology medical device. Manufacturer: Carestream Health, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k173554/ 2018-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k173554-pentax-medical-video-bronchoscopes-fda-510k.jpg K173554 - PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope K173554 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Pentax of America, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k173616/ 2018-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k173616-dip-arthrodesis-system-fda-510k.jpg K173616 - DIP Arthrodesis System K173616 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: In2bones Sas. Cleared Jan 2018. https://www.510kdatabase.net/k173875/ 2018-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k173875-genflex2-total-knee-system-ultra-fda-510k.jpg K173875 - GENFlex2 Total Knee System - Ultra-Congruent CR Tibial Insert K173875 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stelkast, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k173878/ 2018-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k173878-prexion3d-excelsior-fda-510k.jpg K173878 - PreXion3D Excelsior K173878 is a FDA 510(k) cleared radiology medical device. Manufacturer: Prexion Corporation. Cleared Jan 2018. https://www.510kdatabase.net/k173891/ 2018-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k173891-gel-bead-600-800-micron-1-ml-sphere-fda-510k.jpg K173891 - Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume K173891 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vascular Solutions, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k163288/ 2018-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k163288-pelvifine-pelvic-muscle-trainer-fda-510k.jpg K163288 - Pelvifine Pelvic Muscle Trainer K163288 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Shenzhen Konmed Technology Co., Ltd.. Cleared Jan 2018. https://www.510kdatabase.net/k171237/ 2018-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k171237-fms-vue-ii-fluid-management-and-tissue-fda-510k.jpg K171237 - FMS VUE II Fluid Management and Tissue Debridement System K171237 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International SARL. Cleared Jan 2018. https://www.510kdatabase.net/k172259/ 2018-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k172259-pulsioflex-monitoring-system-fda-510k.jpg K172259 - PulsioFlex Monitoring System K172259 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Pulsion Medical Systems SE. Cleared Jan 2018. https://www.510kdatabase.net/k172319/ 2018-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k172319-amsco-v-pro-1-low-temperature-fda-510k.jpg K172319 - AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System K172319 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Jan 2018. https://www.510kdatabase.net/k172575/ 2018-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k172575-baronova-retrieval-kit-baronova-fda-510k.jpg K172575 - BAROnova Retrieval Kit, BAROnova Overtube, BAROnova Endoscope Cap K172575 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baronova, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k172791/ 2018-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k172791-lumilisse-ipl-hair-remover-fda-510k.jpg K172791 - Lumilisse IPL Hair Remover K172791 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Conair Corporation. Cleared Jan 2018. https://www.510kdatabase.net/k172796/ 2018-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k172796-flex-robotic-system-and-flex-fda-510k.jpg K172796 - Flex Robotic System and Flex Transabdominal Drive K172796 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Medrobotics Corporation. Cleared Jan 2018. https://www.510kdatabase.net/k172962/ 2018-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k172962-nurture-rest-fda-510k.jpg K172962 - Nurture Rest K172962 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Neonatal Loving Kare, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k173338/ 2018-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k173338-navigated-infinity-instruments-fda-510k.jpg K173338 - Navigated INFINITY™ Instruments K173338 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k173476/ 2018-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k173476-tritanium-tl-curved-posterior-lumbar-fda-510k.jpg K173476 - Tritanium® TL Curved Posterior Lumbar Cage K173476 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker. Cleared Jan 2018. https://www.510kdatabase.net/k173559/ 2018-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k173559-barrx-sb-rfa-endoscopic-catheter-fda-510k.jpg K173559 - Barrx SB RFA Endoscopic Catheter K173559 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Covidien, LLC. Cleared Jan 2018. https://www.510kdatabase.net/k173866/ 2018-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k173866-stryker-aim-light-source-and-safelight-fda-510k.jpg K173866 - Stryker AIM Light Source and SafeLight cable K173866 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker. Cleared Jan 2018. https://www.510kdatabase.net/k170234/ 2018-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k170234-endotracheal-tube-fda-510k.jpg K170234 - Endotracheal tube K170234 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Zhanjiang Star Enterprise Co., Ltd.. Cleared Jan 2018. https://www.510kdatabase.net/k171247/ 2018-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k171247-epoc-blood-urea-nitrogen-test-epoc-fda-510k.jpg K171247 - epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test K171247 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Epocal, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k171634/ 2018-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k171634-ortho-system-fda-510k.jpg K171634 - Ortho System K171634 is a FDA 510(k) cleared dental medical device. Manufacturer: 3Shape A/S. Cleared Jan 2018. https://www.510kdatabase.net/k172164/ 2018-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k172164-propel-device-fda-510k.jpg K172164 - PROPEL Device K172164 is a FDA 510(k) cleared dental medical device. Manufacturer: Propel Orthodontics, LLC. Cleared Jan 2018. https://www.510kdatabase.net/k173020/ 2018-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k173020-oba-mcp-orthodontic-bracket-adhesive-fda-510k.jpg K173020 - OBA-MCP, Orthodontic Bracket Adhesive with MCP K173020 is a FDA 510(k) cleared dental medical device. Manufacturer: Pulpdent Corporation. Cleared Jan 2018. https://www.510kdatabase.net/k173113/ 2018-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k173113-medline-disposable-electronic-fda-510k.jpg K173113 - Medline Disposable Electronic Thermometer Probe Cover K173113 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k173479/ 2018-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k173479-novofine-32g-tip-023025-x-6-mm-etw-fda-510k.jpg K173479 - NovoFine 32G Tip (0.23/0.25) x 6 mm ETW (extra thin wall) K173479 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Novo Nordisk, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k173582/ 2018-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k173582-thermix-temperature-control-fda-510k.jpg K173582 - ThermiX Temperature Control Radiofrequency System, Accessories - RF Electrodes K173582 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Thermigen, L.L.C. Cleared Jan 2018. https://www.510kdatabase.net/k173730/ 2018-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k173730-kinsa-quickcare-thermometer-fda-510k.jpg K173730 - Kinsa QuickCare Thermometer K173730 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Kinsa, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k173820/ 2018-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k173820-opticross-6-hd-60-mhz-coronary-imaging-fda-510k.jpg K173820 - OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (e-DFU) K173820 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Jan 2018. https://www.510kdatabase.net/k173838/ 2018-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k173838-aria-radiation-therapy-management-fda-510k.jpg K173838 - ARIA Radiation Therapy Management K173838 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k173884/ 2018-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k173884-unity-total-knee-system-fda-510k.jpg K173884 - Unity Total Knee System K173884 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Corin U.S.A. Limited. Cleared Jan 2018. https://www.510kdatabase.net/k171556/ 2018-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k171556-k2m-navigation-instruments-fda-510k.jpg K171556 - K2M Navigation Instruments K171556 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: K2m. Cleared Jan 2018. https://www.510kdatabase.net/k171761/ 2018-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k171761-acclarent-aera-eustachian-tube-balloon-fda-510k.jpg K171761 - ACCLARENT AERA Eustachian Tube Balloon Dilation System K171761 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Acclarent, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k172189/ 2018-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k172189-ins-hilden-humeral-arzzt-ins-hilden-fda-510k.jpg K172189 - Ins Hilden Humeral Arzzt, Ins Hilden Cannulated Tibial Arzzt, Ins Hilden Femoral Arzzt & Ins Hilden Retrograde Femoral Arzzt K172189 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Truemed Group, LLC. Cleared Jan 2018. https://www.510kdatabase.net/k172384/ 2018-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k172384-quickier-q700-up-m-fda-510k.jpg K172384 - Quickie(r) Q700-UP M K172384 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Sunrise Medical (Us), LLC. Cleared Jan 2018. https://www.510kdatabase.net/k172683/ 2018-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k172683-yamahachi-pink-cadcam-disk-fda-510k.jpg K172683 - Yamahachi Pink CAD/CAM Disk K172683 is a FDA 510(k) cleared dental medical device. Manufacturer: YAMAHACHI DENTAL MFG., Co.. Cleared Jan 2018. https://www.510kdatabase.net/k172977/ 2018-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k172977-nanova-2-step-etch-and-rinse-dental-fda-510k.jpg K172977 - Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel K172977 is a FDA 510(k) cleared dental medical device. Manufacturer: Nanova Biomaterials, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k173054/ 2018-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k173054-navigo-workstation-version-20-fda-510k.jpg K173054 - Navigo Workstation Version 2.0 K173054 is a FDA 510(k) cleared radiology medical device. Manufacturer: UC-CARE , Ltd.. Cleared Jan 2018. https://www.510kdatabase.net/k173240/ 2018-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k173240-arthrex-pushlock-fda-510k.jpg K173240 - Arthrex PushLock K173240 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k173622/ 2018-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k173622-cs-imaging-fda-510k.jpg K173622 - CS Imaging K173622 is a FDA 510(k) cleared radiology medical device. Manufacturer: Trophy. Cleared Jan 2018. https://www.510kdatabase.net/k173641/ 2018-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k173641-activ-ankle-fda-510k.jpg K173641 - Activ Ankle K173641 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Newclip Technics. Cleared Jan 2018. https://www.510kdatabase.net/k171799/ 2018-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k171799-elos-accurate-customized-abutment-elos-fda-510k.jpg K171799 - Elos Accurate Customized Abutment, Elos Prosthetic Screw K171799 is a FDA 510(k) cleared dental medical device. Manufacturer: Elos Medtech Pinol A/S. Cleared Jan 2018. https://www.510kdatabase.net/k171354/ 2018-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k171354-mr4-laser-fda-510k.jpg K171354 - MR4 Laser K171354 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Multi Radiance Medical. Cleared Jan 2018. https://www.510kdatabase.net/k163451/ 2018-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k163451-action-trackstander-models-tr1816-fda-510k.jpg K163451 - Action Trackstander models TR1816, TR1820, TR2016, and TR2020 K163451 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Action Manufacturing, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k171148/ 2018-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k171148-aleo-bme-liquid-bandage-fda-510k.jpg K171148 - Aleo BME Liquid Bandage K171148 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aleo Bme, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k171213/ 2018-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k171213-one-touch-condom-with-benzocaine-fda-510k.jpg K171213 - One Touch Condom with Benzocaine K171213 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Thai Nippon Rubber Industry Public Company Limited.. Cleared Jan 2018. https://www.510kdatabase.net/k171292/ 2018-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k171292-a7-anesthesia-system-fda-510k.jpg K171292 - A7 Anesthesia System K171292 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Jan 2018. https://www.510kdatabase.net/k171311/ 2018-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k171311-a5-anesthesia-system-fda-510k.jpg K171311 - A5 Anesthesia System K171311 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Jan 2018. https://www.510kdatabase.net/k171411/ 2018-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k171411-irris-infra-red-red-intubation-system-fda-510k.jpg K171411 - IRRIS (Infra-Red-Red Intubation System) K171411 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: A.R Guide IN Medical , Ltd.. Cleared Jan 2018. https://www.510kdatabase.net/k171498/ 2018-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k171498-msd-crp-assay-kit-and-meso-sector-s-fda-510k.jpg K171498 - MSD CRP Assay Kit and MESO SECTOR S 700 Instrument K171498 is a FDA 510(k) cleared immunology medical device. Manufacturer: Meso Scale Diagnostics, LLC. Cleared Jan 2018. https://www.510kdatabase.net/k171625/ 2018-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k171625-single-lumen-ovum-aspiration-needles-fda-510k.jpg K171625 - Single Lumen Ovum Aspiration Needles K171625 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Willian A. Cook Australia Pty, Ltd.. Cleared Jan 2018. https://www.510kdatabase.net/k171628/ 2018-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k171628-hbs2-headless-bone-screw-fda-510k.jpg K171628 - HBS2 Headless Bone Screw K171628 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stuckenbrock Medizintechnik GmbH. Cleared Jan 2018. https://www.510kdatabase.net/k171958/ 2018-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k171958-piezosurgery-touch-piezosurgery-white-fda-510k.jpg K171958 - PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE K171958 is a FDA 510(k) cleared dental medical device. Manufacturer: Mectron S.P.A.. Cleared Jan 2018. https://www.510kdatabase.net/k172287/ 2018-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k172287-ipsogen-jak2-rgq-pcr-kit-fda-510k.jpg K172287 - ipsogen JAK2 RGQ PCR Kit K172287 is a FDA 510(k) cleared pathology medical device. Manufacturer: Qiagen, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k172438/ 2018-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k172438-arbor-external-fixation-system-fda-510k.jpg K172438 - ARBOR External Fixation System K172438 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k172548/ 2018-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k172548-wiltrom-spinal-fixation-system-fda-510k.jpg K172548 - Wiltrom Spinal Fixation System K172548 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wiltrom Corporation Limited. Cleared Jan 2018. https://www.510kdatabase.net/k172774/ 2018-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k172774-t2-alpha-femur-antegrade-gtpf-nailing-fda-510k.jpg K172774 - T2 Alpha Femur Antegrade GT/PF Nailing System, IMN Screws System, IMN Instruments System K172774 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Trauma GmbH. Cleared Jan 2018. https://www.510kdatabase.net/k172913/ 2018-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k172913-cobas-factor-ii-and-factor-v-test-fda-510k.jpg K172913 - cobas Factor II and Factor V Test K172913 is a FDA 510(k) cleared hematology medical device. Manufacturer: Roche Molecular Systems, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k173291/ 2018-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k173291-6440-ultrasound-system-fda-510k.jpg K173291 - 6440 Ultrasound System K173291 is a FDA 510(k) cleared radiology medical device. Manufacturer: Esaote, S.P.A.. Cleared Jan 2018. https://www.510kdatabase.net/k173504/ 2018-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k173504-k-y-silicone-fda-510k.jpg K173504 - K-Y Silicone K173504 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Reckitt Benckiser, LLC. Cleared Jan 2018. https://www.510kdatabase.net/k173547/ 2018-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k173547-imagenuniversal-fda-510k.jpg K173547 - ImagenUniversal K173547 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cardiovascular Imaging Technologies. Cleared Jan 2018. https://www.510kdatabase.net/k173560/ 2018-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k173560-microcatheter-fda-510k.jpg K173560 - Microcatheter K173560 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Surmodics,Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k173588/ 2018-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k173588-illumeo-system-fda-510k.jpg K173588 - Illumeo System K173588 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Technologies , Ltd.. Cleared Jan 2018. https://www.510kdatabase.net/k173602/ 2018-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k173602-optima-xr240amx-autogrid-fda-510k.jpg K173602 - Optima XR240amx, AutoGrid K173602 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems, LLC. Cleared Jan 2018. https://www.510kdatabase.net/k173635/ 2018-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k173635-syngovia-rt-image-suite-fda-510k.jpg K173635 - syngo.via RT Image Suite K173635 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k173795/ 2018-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k173795-hi-torque-turntrac-guide-wire-family-fda-510k.jpg K173795 - HI-TORQUE TurnTrac Guide Wire Family K173795 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Vascular. Cleared Jan 2018. https://www.510kdatabase.net/k173828/ 2018-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k173828-gu60a-gu60a-65-fda-510k.jpg K173828 - GU60A & GU60A-65 K173828 is a FDA 510(k) cleared radiology medical device. Manufacturer: Samsung Electronics Co., Ltd.. Cleared Jan 2018. https://www.510kdatabase.net/k170421/ 2018-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k170421-et-hybrid-abutment-fda-510k.jpg K170421 - ET Hybrid Abutment K170421 is a FDA 510(k) cleared dental medical device. Manufacturer: Hiossen, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k170748/ 2018-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k170748-global-unite-platform-shoulder-system-fda-510k.jpg K170748 - GLOBAL UNITE Platform Shoulder System K170748 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy Ireland UC. Cleared Jan 2018. https://www.510kdatabase.net/k171122/ 2018-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k171122-cerec-ortho-software-fda-510k.jpg K171122 - CEREC Ortho Software K171122 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Sirona. Cleared Jan 2018. https://www.510kdatabase.net/k171207/ 2018-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k171207-fujifilm-ultrasonic-processor-sp-900-fda-510k.jpg K171207 - FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M K171207 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fujifilm Medical Systems U.S.A, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k171517/ 2018-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k171517-digital-electrocardiograph-fda-510k.jpg K171517 - Digital Electrocardiograph K171517 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biocare Bio-Medical Equipment Co., Ltd.. Cleared Jan 2018. https://www.510kdatabase.net/k171622/ 2018-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k171622-dentium-ti-base-fda-510k.jpg K171622 - Dentium Ti-Base K171622 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentium Co., Ltd.. Cleared Jan 2018. https://www.510kdatabase.net/k171665/ 2018-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k171665-microcatheter-and-guide-wire-system-fda-510k.jpg K171665 - Microcatheter and guide-wire system K171665 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Suzhou Hengrui Disheng Medical Co., Ltd.. Cleared Jan 2018. https://www.510kdatabase.net/k172110/ 2018-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k172110-echelon-oval-v60a-mri-system-fda-510k.jpg K172110 - ECHELON OVAL V6.0A MRI System K172110 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hitachi Healthcare Americas Corporation. Cleared Jan 2018. https://www.510kdatabase.net/k172195/ 2018-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k172195-hydrashift-24-daratumumab-daratumumab-fda-510k.jpg K172195 - HYDRASHIFT 2/4 daratumumab, daratumumab Control K172195 is a FDA 510(k) cleared immunology medical device. Manufacturer: Sebia. Cleared Jan 2018. https://www.510kdatabase.net/k172205/ 2018-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k172205-exotoe-staple-fda-510k.jpg K172205 - ExoToe Staple K172205 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exotoe, LLC. Cleared Jan 2018. https://www.510kdatabase.net/k172224/ 2018-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k172224-dtx-studio-diagnose-fda-510k.jpg K172224 - DTX Studio diagnose K172224 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nobel Biocare AB. Cleared Jan 2018. https://www.510kdatabase.net/k172452/ 2018-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k172452-bruxor-fda-510k.jpg K172452 - Bruxor K172452 is a FDA 510(k) cleared dental medical device. Manufacturer: Sleep Specialties, LLC. Cleared Jan 2018. https://www.510kdatabase.net/k172655/ 2018-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k172655-automated-ankle-brachial-pressure-fda-510k.jpg K172655 - Automated ankle brachial pressure index measuring device K172655 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd.. Cleared Jan 2018. https://www.510kdatabase.net/k172804/ 2018-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k172804-besmed-peak-flow-meter-fda-510k.jpg K172804 - Besmed Peak Flow Meter K172804 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Besmed Health Business Corp. Cleared Jan 2018. https://www.510kdatabase.net/k172992/ 2018-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k172992-diazyme-ez-vitamin-d-assay-fda-510k.jpg K172992 - Diazyme EZ Vitamin D Assay K172992 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diazyme Laboratories. Cleared Jan 2018. https://www.510kdatabase.net/k173090/ 2018-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k173090-aplio-i900i800i700i600-diagnostic-fda-510k.jpg K173090 - Aplio i900/i800/i700/i600 Diagnostic Ultrasound System, V2.4 K173090 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshibamedical Systems Corporation. Cleared Jan 2018. https://www.510kdatabase.net/k171421/ 2018-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k171421-verticale-posterior-spinal-fixation-fda-510k.jpg K171421 - VERTICALE® Posterior Spinal Fixation System/VERTICALE® System K171421 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Silony Medical GmbH. Cleared Jan 2018. https://www.510kdatabase.net/k171445/ 2018-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k171445-amplatz-support-wire-guide-with-apex-fda-510k.jpg K171445 - Amplatz Support Wire Guide with Apex Curve K171445 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Jan 2018. https://www.510kdatabase.net/k171722/ 2018-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k171722-electrodes-with-snap-electrodes-with-fda-510k.jpg K171722 - Electrodes with snap / Electrodes with pigtail K171722 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Konmed Technology Co., Ltd.. Cleared Jan 2018. https://www.510kdatabase.net/k171833/ 2018-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k171833-digital-blood-pressure-monitor-wrist-fda-510k.jpg K171833 - Digital Blood Pressure Monitor-Wrist Style K171833 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Combei Technology Co., Ltd.. Cleared Jan 2018. https://www.510kdatabase.net/k172051/ 2018-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k172051-guardia-access-nano-and-soft-trans-fda-510k.jpg K172051 - Guardia™ Access Nano and Soft-Trans Embryo Transfer Catheter Sets, Soft-Trans Embryo Transfer Catheter, Soft-Trans Guide Catheter K172051 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Cook Incorporated. Cleared Jan 2018. https://www.510kdatabase.net/k172336/ 2018-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k172336-smith-nephew-patient-matched-cutting-fda-510k.jpg K172336 - Smith & Nephew Patient Matched Cutting Blocks K172336 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k172358/ 2018-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k172358-instalief-fda-510k.jpg K172358 - Instalief K172358 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Privi Medical Pte, Ltd.. Cleared Jan 2018. https://www.510kdatabase.net/k172929/ 2018-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k172929-amplatz-type-renal-sheaths-amplatz-fda-510k.jpg K172929 - Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath K172929 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Jan 2018. https://www.510kdatabase.net/k173170/ 2018-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k173170-epicardia-anywhere-fda-510k.jpg K173170 - Epicardia Anywhere K173170 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medicomp, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k173234/ 2018-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k173234-swiss-lithoclast-trilogy-fda-510k.jpg K173234 - Swiss LithoClast Trilogy K173234 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: E.M.S Electro Medical Systems S.A. Cleared Jan 2018. https://www.510kdatabase.net/k173563/ 2018-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k173563-arc-adjustable-radial-cuff-compression-fda-510k.jpg K173563 - ARC ADJUSTABLE RADIAL CUFF COMPRESSION DEVICE K173563 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Tz Medical, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k173768/ 2018-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k173768-tempus-pro-patient-monitor-fda-510k.jpg K173768 - Tempus Pro Patient Monitor K173768 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Remote Diagnostic Technologies , Ltd.. Cleared Jan 2018. https://www.510kdatabase.net/k163026/ 2018-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k163026-ultraphonic-scanning-gel-fda-510k.jpg K163026 - Ultra/Phonic Scanning Gel K163026 is a FDA 510(k) cleared radiology medical device. Manufacturer: Pharmaceutical Innovations, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k163027/ 2018-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k163027-ultraphonic-free-conductivity-gel-fda-510k.jpg K163027 - Ultra/Phonic Free Conductivity Gel K163027 is a FDA 510(k) cleared radiology medical device. Manufacturer: Pharmaceutical Innovations, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k171295/ 2018-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k171295-ulab-systems-treatment-planning-software-fda-510k.jpg K171295 - ULab Systems Treatment Planning Software K171295 is a FDA 510(k) cleared dental medical device. Manufacturer: Ulab Systems, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k171775/ 2018-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k171775-theradome-lh80-pro-fda-510k.jpg K171775 - Theradome LH80 PRO K171775 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Theradome, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k172183/ 2018-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k172183-guided-growth-plate-system-plus-fda-510k.jpg K172183 - Guided Growth Plate System Plus K172183 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Orthofix Srl. Cleared Jan 2018. https://www.510kdatabase.net/k172193/ 2018-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k172193-modified-alma-lasers-soprano-xl-family-fda-510k.jpg K172193 - Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser Modules K172193 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Alma Lasers, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k172212/ 2018-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k172212-matisse-anterior-cervical-interbody-fda-510k.jpg K172212 - MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ K172212 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ctl Medical Corporation. Cleared Jan 2018. https://www.510kdatabase.net/k172662/ 2018-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k172662-revive-perioral-fda-510k.jpg K172662 - reVive Perioral K172662 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Led Technologies, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k173021/ 2018-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k173021-aixplorer-aixplorer-ultimate-fda-510k.jpg K173021 - Aixplorer & Aixplorer Ultimate Ultrasound Diagnostic Systems K173021 is a FDA 510(k) cleared radiology medical device. Manufacturer: Supersonic Imagine. Cleared Jan 2018. https://www.510kdatabase.net/k173263/ 2018-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k173263-xpert-carba-r-fda-510k.jpg K173263 - Xpert Carba-R K173263 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Cepheid. Cleared Jan 2018. https://www.510kdatabase.net/k173469/ 2018-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k173469-16ch-tr-hand-wrist-coil-fda-510k.jpg K173469 - 16ch T/R Hand Wrist Coil K173469 is a FDA 510(k) cleared radiology medical device. Manufacturer: Quality Electrodynamics, LLC. Cleared Jan 2018. https://www.510kdatabase.net/k173508/ 2018-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k173508-everest-spinal-system-fda-510k.jpg K173508 - Everest Spinal System K173508 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: K2m. Cleared Jan 2018. https://www.510kdatabase.net/k163023/ 2018-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k163023-other-sonic-transmission-gel-fda-510k.jpg K163023 - Other-Sonic Transmission Gel K163023 is a FDA 510(k) cleared radiology medical device. Manufacturer: Pharmaceutical Innovations, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k163024/ 2018-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k163024-ultraphonic-conductivity-gel-fda-510k.jpg K163024 - Ultra/Phonic Conductivity Gel K163024 is a FDA 510(k) cleared radiology medical device. Manufacturer: Pharmaceutical Innovations, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k171328/ 2018-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k171328-cneuro-cmri-fda-510k.jpg K171328 - cNeuro cMRI K171328 is a FDA 510(k) cleared radiology medical device. Manufacturer: Combinostics OY. Cleared Jan 2018. https://www.510kdatabase.net/k172858/ 2018-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k172858-preop-fda-510k.jpg K172858 - PreOp K172858 is a FDA 510(k) cleared neurology medical device. Manufacturer: Epilog. Cleared Jan 2018. https://www.510kdatabase.net/k172942/ 2018-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k172942-pristeen-latex-surgeons-gloves-powder-fda-510k.jpg K172942 - Pristeen (Latex Surgeon’s Gloves Powder Free, Polymer coated with protein content labeling claim of 50 ug/dm2 or less per glove of extractable protein K172942 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Beta Healthcare Products Pvt., Ltd.. Cleared Jan 2018. https://www.510kdatabase.net/k173085/ 2018-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k173085-invendoscopy-e210-system-fda-510k.jpg K173085 - invendoscopy E210 System K173085 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Invendo Medical GmbH. Cleared Jan 2018. https://www.510kdatabase.net/k173159/ 2018-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k173159-cervical-spinal-truss-system-csts-fda-510k.jpg K173159 - Cervical Spinal Truss System (CSTS) Interbody Fusion Device K173159 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 4Web, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k173293/ 2018-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k173293-evos-small-fragment-upper-extremity-fda-510k.jpg K173293 - EVOS Small Fragment Upper Extremity Plates K173293 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k173471/ 2018-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k173471-dc-80dc-80-prodc-80-expdc-80sdc-85-fda-510k.jpg K173471 - DC-80/DC-80 PRO/DC-80 EXP/DC-80S/DC-85 Diagnostic K173471 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Jan 2018. https://www.510kdatabase.net/k173759/ 2018-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k173759-thermage-cpt-system-and-accessories-fda-510k.jpg K173759 - Thermage CPT System and Accessories K173759 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Solta Medical. Cleared Jan 2018. https://www.510kdatabase.net/k171099/ 2018-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k171099-eon-portable-reverse-osmosis-water-fda-510k.jpg K171099 - EON Portable Reverse Osmosis Water Purification System K171099 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cantel. Cleared Jan 2018. https://www.510kdatabase.net/k171436/ 2018-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k171436-strong-dental-handpieces-fda-510k.jpg K171436 - STRONG Dental Handpieces K171436 is a FDA 510(k) cleared dental medical device. Manufacturer: Saeshin Precision Co., Ltd.. Cleared Jan 2018. https://www.510kdatabase.net/k171518/ 2018-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k171518-epidural-anesthesia-needles-spinal-fda-510k.jpg K171518 - Epidural Anesthesia Needles, Spinal Anesthesia Needles, Combined Anesthesia Needles K171518 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Zhejiang Kindly Medical Devices Co., Ltd.. Cleared Jan 2018. https://www.510kdatabase.net/k171721/ 2018-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k171721-electrodes-with-silver-conductive-fda-510k.jpg K171721 - Electrodes with silver conductive K171721 is a FDA 510(k) cleared neurology medical device. Manufacturer: Shenzhen Konmed Technology Co., Ltd.. Cleared Jan 2018. https://www.510kdatabase.net/k171860/ 2018-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k171860-sureclear-aligners-fda-510k.jpg K171860 - Sureclear aligners K171860 is a FDA 510(k) cleared dental medical device. Manufacturer: Emergo Global Consulting, LLC. Cleared Jan 2018. https://www.510kdatabase.net/k171948/ 2018-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k171948-roadrunner-extra-support-wire-guide-fda-510k.jpg K171948 - Roadrunner Extra Support Wire Guide K171948 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Jan 2018. https://www.510kdatabase.net/k172029/ 2018-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k172029-ensoetm-fda-510k.jpg K172029 - EnsoETM K172029 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Attune Medical. Cleared Jan 2018. https://www.510kdatabase.net/k172169/ 2018-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k172169-pulpdent-activa-pit-and-fissure-fda-510k.jpg K172169 - Pulpdent (Activa) Pit and Fissure Sealant with MCP K172169 is a FDA 510(k) cleared dental medical device. Manufacturer: Pulpdent Corporation. Cleared Jan 2018. https://www.510kdatabase.net/k172518/ 2018-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k172518-spineology-navigation-instruments-fda-510k.jpg K172518 - Spineology Navigation Instruments K172518 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spineology, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k172968/ 2018-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k172968-hair-up-fda-510k.jpg K172968 - Hair Up K172968 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Y & J Bio Co., Ltd.. Cleared Jan 2018. https://www.510kdatabase.net/k173252/ 2018-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k173252-bd-phoenix-automated-microbiology-fda-510k.jpg K173252 - BD Phoenix Automated Microbiology System - GN Ceftolozane/tazobactam (0.25/4-32/4 ug/mL) K173252 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson and Company. Cleared Jan 2018. https://www.510kdatabase.net/k173278/ 2018-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k173278-toggleloc-system-fda-510k.jpg K173278 - ToggleLoc System K173278 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k173456/ 2018-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k173456-viewpoint-6-fda-510k.jpg K173456 - ViewPoint 6 K173456 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems Ultrasound and Primary. Cleared Jan 2018. https://www.510kdatabase.net/k173650/ 2018-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k173650-aquashield-system-co2-fujifilm-fda-510k.jpg K173650 - AquaShield System CO2- Fujifilm K173650 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: United States Endoscopy Group, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k171056/ 2018-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k171056-wave-clinical-platform-fda-510k.jpg K171056 - WAVE Clinical Platform K171056 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Excel Medical Electronics, LLC. Cleared Jan 2018. https://www.510kdatabase.net/k171113/ 2018-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k171113-lina-operascope-with-hdmi-cable-and-on-fda-510k.jpg K171113 - LiNA OperaScope with HDMI cable and on-board LCD-single unit, LiNA OperaScope with HDMI cable and on-board LCD-6 units, LiNA OperaScope Recording Module K171113 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Lina Medical Aps. Cleared Jan 2018. https://www.510kdatabase.net/k171235/ 2018-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k171235-omnicap-fda-510k.jpg K171235 - OmniCap K171235 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respirion, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k171372/ 2018-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k171372-alians-elbow-locking-plating-system-fda-510k.jpg K171372 - Alians Elbow Locking Plating System K171372 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Newclip Technics. Cleared Jan 2018. https://www.510kdatabase.net/k171410/ 2018-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k171410-epatch-fda-510k.jpg K171410 - ePatch K171410 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Braemar Manufacturing, LLC. Cleared Jan 2018. https://www.510kdatabase.net/k171819/ 2018-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k171819-attain-assist-cs-access-catheter-fda-510k.jpg K171819 - Attain Assist CS Access Catheter K171819 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Creganna Medical Also Doing Business AS Ceganna Tactx Medica. Cleared Jan 2018. https://www.510kdatabase.net/k171836/ 2018-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k171836-earlysense-bed-sensing-unit-fda-510k.jpg K171836 - EarlySense Bed Sensing Unit K171836 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Earlysense, Ltd.. Cleared Jan 2018. https://www.510kdatabase.net/k172456/ 2018-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k172456-bone-screws-65mm-fda-510k.jpg K172456 - Bone Screws 6.5mm K172456 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Lima Corporate S.P.A.. Cleared Jan 2018. https://www.510kdatabase.net/k172701/ 2018-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k172701-bio-c-sealer-fda-510k.jpg K172701 - BIO-C SEALER K172701 is a FDA 510(k) cleared dental medical device. Manufacturer: Angelus Industria DE Produtos Odontologicos S/A. Cleared Jan 2018. https://www.510kdatabase.net/k172702/ 2018-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k172702-tec-820-tec-850-fda-510k.jpg K172702 - Tec 820, Tec 850 K172702 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Datex-Ohmeda, Inc.. Cleared Jan 2018. https://www.510kdatabase.net/k170924/ 2018-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k170924-airfit-f20-fda-510k.jpg K170924 - AirFit F20 K170924 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Resmed, Ltd.. Cleared Jan 2018. https://www.510kdatabase.net/k172502/ 2018-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k172502-comprehensive-augmented-glenoid-fda-510k.jpg K172502 - Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate K172502 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet Manufacturing Corp. Cleared Jan 2018. https://www.510kdatabase.net/k172798/ 2018-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k172798-straumann-cares-abutments-cocr-fda-510k.jpg K172798 - Straumann CARES Abutments CoCr K172798 is a FDA 510(k) cleared dental medical device. Manufacturer: Institut Straumann AG. Cleared Jan 2018. https://www.510kdatabase.net/k173198/ 2018-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k173198-facet-screw-fixation-system-fda-510k.jpg K173198 - Facet Screw Fixation System K173198 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: U&I Corporation. Cleared Jan 2018. https://www.510kdatabase.net/k173702/ 2018-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k173702-juliet-ti-ll-fda-510k.jpg K173702 - Juliet Ti LL K173702 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Spineart. Cleared Jan 2018. https://www.510kdatabase.net/k163712/ 2018-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k163712-clover-50clover60clover70-diagnostic-fda-510k.jpg K163712 - Clover 50/Clover60/Clover70 Diagnostic Ultrasound System K163712 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Wisonic Medical Technology Co. , Ltd.. Cleared Jan 2018. https://www.510kdatabase.net/k171529/ 2018-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k171529-snorers-friend-fda-510k.jpg K171529 - Snorer's Friend K171529 is a FDA 510(k) cleared dental medical device. Manufacturer: Scope Healthcare Technologies Pty, Ltd.. Cleared Jan 2018. https://www.510kdatabase.net/k172860/ 2018-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k172860-resona-6resona-6tresona-6expresona-fda-510k.jpg K172860 - Resona 6/Resona 6T/Resona 6EXP/Resona 6Elite Diagnostic Ultrasound System/Resona 6S/Resona 6PRO/Resona 6OB Diagnostic Ultrasound System /Resona 5/Resona 5T/Resona 5EXP/Resona 5Elite Diagnostic Ultrasound System K172860 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Jan 2018. https://www.510kdatabase.net/k171108/ 2017-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k171108-autobahn-nailing-system-fda-510k.jpg K171108 - AUTOBAHN Nailing System K171108 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Dec 2017. https://www.510kdatabase.net/k171573/ 2017-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k171573-fusion-cytology-brush-cytomax-ii-fda-510k.jpg K171573 - Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush K171573 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Wilson-Cook Medical, Inc.. Cleared Dec 2017. https://www.510kdatabase.net/k172474/ 2017-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k172474-celerity-20-hp-biological-indicator-fda-510k.jpg K172474 - Celerity 20 HP Biological Indicator K172474 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Dec 2017. https://www.510kdatabase.net/k173403/ 2017-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k173403-gem-premier-5000-fda-510k.jpg K173403 - GEM Premier 5000 K173403 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Dec 2017. https://www.510kdatabase.net/k173664/ 2017-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k173664-medtronic-o-arm-o2-imaging-system-fda-510k.jpg K173664 - Medtronic O-arm O2 Imaging System K173664 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medtronic, Inc.. Cleared Dec 2017. https://www.510kdatabase.net/k171061/ 2017-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k171061-mrsaselect-ii-fda-510k.jpg K171061 - MRSASelect II K171061 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bio-Rad. Cleared Dec 2017. https://www.510kdatabase.net/k173073/ 2017-12-26 monthly 0.5 https://www.510kdatabase.net/og-image/k173073-altivate-anatomic-to-reverse-fda-510k.jpg K173073 - AltiVate Anatomic to Reverse Conversion Module K173073 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Encore Medical, L.P.. Cleared Dec 2017. https://www.510kdatabase.net/k170960/ 2017-12-25 monthly 0.5 https://www.510kdatabase.net/og-image/k170960-coaguchek-vantus-system-fda-510k.jpg K170960 - CoaguChek Vantus System K170960 is a FDA 510(k) cleared hematology medical device. Manufacturer: Roche Diagnostics. Cleared Dec 2017. https://www.510kdatabase.net/k170993/ 2017-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k170993-quanta-flash-calprotectin-reagents-fda-510k.jpg K170993 - QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer K170993 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Dec 2017. https://www.510kdatabase.net/k171584/ 2017-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k171584-b-braun-tear-away-introducer-needle-fda-510k.jpg K171584 - B. Braun Tear-Away Introducer Needle K171584 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Dec 2017. https://www.510kdatabase.net/k171848/ 2017-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k171848-fortify-and-fortify-integrated-fda-510k.jpg K171848 - FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO Corpectomy Spacers, SUSTAIN Spacers, COALITION Spacers, PATRIOT Lumbar Spacers, PATRIOT Cervical Spacers, ALTERA Spacers, RISE Spacers, CALIBER Spacers, ELSA Spacers, LATIS Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, MAGNIFY Spacers, INDEPENDENCE Spacers K171848 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Dec 2017. https://www.510kdatabase.net/k172321/ 2017-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k172321-shepard-insemi-cath-and-soft-pass-fda-510k.jpg K172321 - Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters K172321 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Cook Incorporated. Cleared Dec 2017. https://www.510kdatabase.net/k172623/ 2017-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k172623-nuvasive-navigation-instruments-fda-510k.jpg K172623 - NuVasive Navigation Instruments K172623 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Dec 2017. https://www.510kdatabase.net/k172922/ 2017-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k172922-mmpc-4127f1-fda-510k.jpg K172922 - MMPC-4127F1 K172922 is a FDA 510(k) cleared pathology medical device. Manufacturer: Barco N.V.. Cleared Dec 2017. https://www.510kdatabase.net/k172973/ 2017-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k172973-life-spine-foot-and-ankle-plating-system-fda-510k.jpg K172973 - Life Spine Foot and Ankle Plating System K172973 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Dec 2017. https://www.510kdatabase.net/k171275/ 2017-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k171275-micropuncture-introducer-set-fda-510k.jpg K171275 - Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus Design, Micropuncture Introducer Set with Silhouette Transitionless Design, Micropuncture Introducer Set with Silhouette Transitionless Design and Push-Plus Design K171275 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Dec 2017. https://www.510kdatabase.net/k172565/ 2017-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k172565-advantageadvantage-fit-delivery-device-fda-510k.jpg K172565 - Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device K172565 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Dec 2017. https://www.510kdatabase.net/k173115/ 2017-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k173115-coalition-and-coalition-tps-coalition-fda-510k.jpg K173115 - COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS K173115 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Dec 2017. https://www.510kdatabase.net/k173125/ 2017-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k173125-t2-stratosphere-expandable-corpectomy-fda-510k.jpg K173125 - T2 STRATOSPHERE™ Expandable Corpectomy System K173125 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Dec 2017. https://www.510kdatabase.net/k173182/ 2017-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k173182-prolift-expandable-system-fda-510k.jpg K173182 - ProLift® Expandable System K173182 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Dec 2017. https://www.510kdatabase.net/k173555/ 2017-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k173555-logiq-e10-fda-510k.jpg K173555 - LOGIQ E10 K173555 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Dec 2017. https://www.510kdatabase.net/k173578/ 2017-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k173578-biograph-mct-family-of-petct-systems-fda-510k.jpg K173578 - Biograph mCT Family of PET/CT Systems K173578 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Dec 2017. https://www.510kdatabase.net/k173685/ 2017-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k173685-peel-away-introducer-set-fda-510k.jpg K173685 - Peel-Away Introducer Set K173685 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Dec 2017. https://www.510kdatabase.net/k172944/ 2017-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k172944-vitek-2-ast-gn-ceftazidimeavibactam-fda-510k.jpg K172944 - VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 – >=16 µg/mL K172944 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Dec 2017. https://www.510kdatabase.net/k173251/ 2017-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k173251-lumicoil-platinum-fiducial-marker-fda-510k.jpg K173251 - LumiCoil Platinum Fiducial Marker K173251 is a FDA 510(k) cleared radiology medical device. Manufacturer: Boston Scientific Corporation. Cleared Dec 2017. https://www.510kdatabase.net/k173600/ 2017-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k173600-magnetom-amira-fda-510k.jpg K173600 - MAGNETOM Amira K173600 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Dec 2017. https://www.510kdatabase.net/k173618/ 2017-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k173618-acuson-acunav-volume-intracardiac-fda-510k.jpg K173618 - ACUSON AcuNav Volume Intracardiac Echocardiography Catheter K173618 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Dec 2017. https://www.510kdatabase.net/k171271/ 2017-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k171271-polyform-synthetic-mesh-fda-510k.jpg K171271 - Polyform Synthetic Mesh K171271 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Boston Scientific Corporation. Cleared Dec 2017. https://www.510kdatabase.net/k172337/ 2017-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k172337-microscan-dried-gram-negative-miccombo-fda-510k.jpg K172337 - MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 ug/mL) K172337 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Dec 2017. https://www.510kdatabase.net/k172482/ 2017-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k172482-the-nellcor-pulse-oximetry-monitor-fda-510k.jpg K172482 - The Nellcor pulse oximetry monitor interface cable K172482 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Covidien. Cleared Dec 2017. https://www.510kdatabase.net/k173532/ 2017-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k173532-raider-guidewire-fda-510k.jpg K173532 - Raider Guidewire K173532 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vascular Solutions, Inc.. Cleared Dec 2017. https://www.510kdatabase.net/k173687/ 2017-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k173687-strange-bile-duct-stone-exploration-set-fda-510k.jpg K173687 - Strange Bile Duct Stone Exploration Set K173687 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Dec 2017. https://www.510kdatabase.net/k170414/ 2017-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k170414-arthrex-univers-revers-apex-humeral-fda-510k.jpg K170414 - Arthrex Univers Revers Apex Humeral Stems K170414 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Dec 2017. https://www.510kdatabase.net/k172009/ 2017-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k172009-cascadia-interbody-system-fda-510k.jpg K172009 - Cascadia Interbody System K172009 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: K2m, Inc.. Cleared Dec 2017. https://www.510kdatabase.net/k172676/ 2017-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k172676-nuvasive-modulus-c-interbody-system-fda-510k.jpg K172676 - NuVasive® Modulus-C Interbody System K172676 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Dec 2017. https://www.510kdatabase.net/k172854/ 2017-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k172854-nobelperfect-abutments-fda-510k.jpg K172854 - NobelPerfect Abutments K172854 is a FDA 510(k) cleared dental medical device. Manufacturer: Nobel Biocare AB. Cleared Dec 2017. https://www.510kdatabase.net/k172863/ 2017-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k172863-infinix-i-infx-8000v-v70-fda-510k.jpg K172863 - Infinix-i, INFX-8000V, V7.0 K172863 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshibamedical Systems Corporation. Cleared Dec 2017. https://www.510kdatabase.net/k173286/ 2017-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k173286-cannulated-screw-internal-fixation-fda-510k.jpg K173286 - Cannulated Screw Internal Fixation System K173286 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Dec 2017. https://www.510kdatabase.net/k171058/ 2017-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k171058-medacta-shoulder-system-threaded-fda-510k.jpg K171058 - Medacta Shoulder System: Threaded Glenoid Baseplate K171058 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Dec 2017. https://www.510kdatabase.net/k172052/ 2017-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k172052-arthrex-dynanite-nitinol-staple-fda-510k.jpg K172052 - Arthrex DynaNite Nitinol Staple K172052 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Dec 2017. https://www.510kdatabase.net/k172217/ 2017-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k172217-flexor-ureteral-access-sheath-and-fda-510k.jpg K172217 - Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath K172217 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Dec 2017. https://www.510kdatabase.net/k172651/ 2017-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k172651-fmp-extended-liners-fda-510k.jpg K172651 - FMP Extended Liners K172651 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Encore Medical, L.P.. Cleared Dec 2017. https://www.510kdatabase.net/k172932/ 2017-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k172932-true-flow-valvuloplasty-perfusion-fda-510k.jpg K172932 - True Flow Valvuloplasty Perfusion Catheter K172932 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 2017. https://www.510kdatabase.net/k173621/ 2017-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k173621-advocate-pta-catheter-fda-510k.jpg K173621 - Advocate PTA Catheter K173621 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Dec 2017. https://www.510kdatabase.net/k170898/ 2017-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k170898-wittich-nitinol-stone-basket-fda-510k.jpg K170898 - Wittich Nitinol Stone Basket K170898 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Dec 2017. https://www.510kdatabase.net/k172276/ 2017-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k172276-xario-200-diagnostic-ultrasound-system-fda-510k.jpg K172276 - Xario 200 Diagnostic Ultrasound System V6.0 K172276 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshibamedical Systems Corporation. Cleared Dec 2017. https://www.510kdatabase.net/k173467/ 2017-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k173467-advanced-diffusion-analysis-ada-fda-510k.jpg K173467 - Advanced Diffusion Analysis (ADA) application K173467 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Dec 2017. https://www.510kdatabase.net/k173480/ 2017-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k173480-crystalsert-lens-delivery-system-fda-510k.jpg K173480 - Crystalsert Lens Delivery System K173480 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Bausch & Lomb, Inc.. Cleared Dec 2017. https://www.510kdatabase.net/k172731/ 2017-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k172731-vitek-2-ast-gn-amikacin-1-64-ugml-fda-510k.jpg K172731 - VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL) K172731 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Dec 2017. https://www.510kdatabase.net/k172734/ 2017-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k172734-single-use-electrosurgical-snare-sd-400-fda-510k.jpg K172734 - Single Use Electrosurgical Snare SD-400 K172734 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Dec 2017. https://www.510kdatabase.net/k172912/ 2017-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k172912-microscan-dried-gram-negative-miccombo-fda-510k.jpg K172912 - MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 – 8 µg/mL) K172912 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Dec 2017. https://www.510kdatabase.net/k173117/ 2017-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k173117-nuvasive-versatie-system-fda-510k.jpg K173117 - NuVasive® VersaTie™ System K173117 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nuvasive, Inc.. Cleared Dec 2017. https://www.510kdatabase.net/k173267/ 2017-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k173267-masterloc-stem-lateralized-plus-fda-510k.jpg K173267 - MasterLoc Stem: Lateralized Plus K173267 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Dec 2017. https://www.510kdatabase.net/k173153/ 2017-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k173153-vertera-spine-coalesce-thoracolumbar-fda-510k.jpg K173153 - Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion System K173153 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Dec 2017. https://www.510kdatabase.net/k172618/ 2017-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k172618-systems-integration-endoalpha-medical-fda-510k.jpg K172618 - SYSTEMS INTEGRATION ENDOALPHA MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4 Software Version 1 K172618 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Dec 2017. https://www.510kdatabase.net/k171771/ 2017-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k171771-advia-chemistry-enzymatic-hemoglobin-fda-510k.jpg K171771 - ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay K171771 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Dec 2017. https://www.510kdatabase.net/k172629/ 2017-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k172629-panther-fusion-advhmpvrv-assay-fda-510k.jpg K172629 - Panther Fusion AdV/hMPV/RV Assay K172629 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Hologic, Inc.. Cleared Dec 2017. https://www.510kdatabase.net/k171773/ 2017-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k171773-straumann-nce-glass-ceramic-a14-blocks-fda-510k.jpg K171773 - Straumann n!ce Glass Ceramic A14 Blocks K171773 is a FDA 510(k) cleared dental medical device. Manufacturer: Institut Straumann AG. Cleared Dec 2017. https://www.510kdatabase.net/k172255/ 2017-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k172255-microscan-dried-gram-negative-miccombo-fda-510k.jpg K172255 - MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL) K172255 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Dec 2017. https://www.510kdatabase.net/k173266/ 2017-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k173266-octane-aspiration-system-fda-510k.jpg K173266 - Octane aspiration system K173266 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vascular Solutions, Inc.. Cleared Dec 2017. https://www.510kdatabase.net/k171934/ 2017-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k171934-birmingham-hip-bh-dual-mobility-insert-fda-510k.jpg K171934 - Birmingham Hip (BH) Dual Mobility Insert K171934 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Nov 2017. https://www.510kdatabase.net/k172637/ 2017-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k172637-hero-graft-fda-510k.jpg K172637 - HeRO Graft K172637 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Nov 2017. https://www.510kdatabase.net/k172767/ 2017-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k172767-zimmer-trabecular-metal-reverse-fda-510k.jpg K172767 - Zimmer Trabecular Metal Reverse Shoulder System, Mini Glenoid K172767 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Nov 2017. https://www.510kdatabase.net/k173522/ 2017-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k173522-solanas-posterior-stabilization-system-fda-510k.jpg K173522 - Solanas® Posterior Stabilization System K173522 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Alphatec Spine, Inc.. Cleared Nov 2017. https://www.510kdatabase.net/k170690/ 2017-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k170690-m-vizion-femoral-revision-system-fda-510k.jpg K170690 - M-Vizion Femoral Revision System K170690 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Nov 2017. https://www.510kdatabase.net/k171466/ 2017-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k171466-nobeldesign-dtx-studio-design-fda-510k.jpg K171466 - NobelDesign, DTX Studio Design K171466 is a FDA 510(k) cleared dental medical device. Manufacturer: Nobel Biocare AB. Cleared Nov 2017. https://www.510kdatabase.net/k170811/ 2017-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k170811-single-use-retrieval-nitinol-basket-v-fda-510k.jpg K170811 - Single Use Retrieval Nitinol Basket V K170811 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Nov 2017. https://www.510kdatabase.net/k171114/ 2017-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k171114-healix-advance-knotless-anchor-fda-510k.jpg K171114 - HEALIX ADVANCE KNOTLESS Anchor K171114 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International SARL. Cleared Nov 2017. https://www.510kdatabase.net/k172497/ 2017-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k172497-nuvasive-attrax-scaffold-fda-510k.jpg K172497 - NuVasive AttraX Scaffold K172497 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Nov 2017. https://www.510kdatabase.net/k172278/ 2017-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k172278-firlit-kluge-urethral-stent-koyle-fda-510k.jpg K172278 - Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent K172278 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Nov 2017. https://www.510kdatabase.net/k172822/ 2017-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k172822-azurion-series-r12-fda-510k.jpg K172822 - Azurion series R1.2 K172822 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Nov 2017. https://www.510kdatabase.net/k172903/ 2017-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k172903-hemosil-d-dimer-hs-500-fda-510k.jpg K172903 - HemosIL D-Dimer HS 500 K172903 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Nov 2017. https://www.510kdatabase.net/k173183/ 2017-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k173183-cedia-heroin-metabolite-6-am-assay-fda-510k.jpg K173183 - CEDIA Heroin Metabolite (6-AM) Assay K173183 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Microgenics Corporation. Cleared Nov 2017. https://www.510kdatabase.net/k163579/ 2017-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k163579-kls-martin-individual-patient-solutions-fda-510k.jpg K163579 - KLS Martin Individual Patient Solutions K163579 is a FDA 510(k) cleared dental medical device. Manufacturer: KLS-Martin L.P.. Cleared Nov 2017. https://www.510kdatabase.net/k171073/ 2017-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k171073-smith-nephew-inc-redapt-augments-fda-510k.jpg K171073 - Smith & Nephew, Inc. REDAPT Augments K171073 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Nov 2017. https://www.510kdatabase.net/k173030/ 2017-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k173030-vertera-spine-cohere-cervical-fda-510k.jpg K173030 - Vertera Spine Cohere Cervical Interbody Fusion Device K173030 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Nov 2017. https://www.510kdatabase.net/k172921/ 2017-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k172921-stryker-self-punching-iconix-fda-510k.jpg K172921 - Stryker Self-Punching ICONIX K172921 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker. Cleared Nov 2017. https://www.510kdatabase.net/k172984/ 2017-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k172984-affinity-pixie-oxygenator-with-balance-fda-510k.jpg K172984 - Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Pixie Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Cortiva BioActive Surface K172984 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Nov 2017. https://www.510kdatabase.net/k170544/ 2017-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k170544-langston-dual-lumen-catheter-fda-510k.jpg K170544 - Langston dual lumen catheter K170544 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vascular Solutions, Inc.. Cleared Nov 2017. https://www.510kdatabase.net/k171121/ 2017-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k171121-masimo-root-monitoring-system-and-fda-510k.jpg K171121 - Masimo Root Monitoring System and Accessories K171121 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Masimo Corporation. Cleared Nov 2017. https://www.510kdatabase.net/k171158/ 2017-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k171158-single-use-electrosurgical-knife-fda-510k.jpg K171158 - Single Use Electrosurgical knife K171158 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Nov 2017. https://www.510kdatabase.net/k172472/ 2017-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k172472-micro-mec-18-glutaraldehyde-monitor-fda-510k.jpg K172472 - Micro-MEC 1.8% Glutaraldehyde Monitor Strip K172472 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Nov 2017. https://www.510kdatabase.net/k172660/ 2017-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k172660-duravess-bovine-pericardial-vascular-fda-510k.jpg K172660 - Duravess bovine pericardial vascular patch K172660 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Nov 2017. https://www.510kdatabase.net/k172850/ 2017-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k172850-sterilcontainer-with-primeline-pro-lid-fda-510k.jpg K172850 - SterilContainer with PrimeLine Pro Lid K172850 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Aesculap, Inc.. Cleared Nov 2017. https://www.510kdatabase.net/k173023/ 2017-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k173023-symbia-t16-symbia-intevo-16-and-symbia-fda-510k.jpg K173023 - Symbia T16, Symbia Intevo 16 and Symbia Intevo Bold K173023 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2017. https://www.510kdatabase.net/k173068/ 2017-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k173068-performer-introducer-fda-510k.jpg K173068 - Performer Introducer K173068 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Nov 2017. https://www.510kdatabase.net/k173355/ 2017-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k173355-gastric-sizing-balloon-catheter-fda-510k.jpg K173355 - Gastric Sizing Balloon Catheter K173355 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Nov 2017. https://www.510kdatabase.net/k173284/ 2017-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k173284-opticross-hd-60-mhz-coronary-imaging-fda-510k.jpg K173284 - OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU) K173284 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Nov 2017. https://www.510kdatabase.net/k173314/ 2017-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k173314-lessray-system-fda-510k.jpg K173314 - LessRay System K173314 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Nov 2017. https://www.510kdatabase.net/k173331/ 2017-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k173331-journey-ii-xr-knee-instruments-fda-510k.jpg K173331 - JOURNEY II XR Knee Instruments K173331 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Nov 2017. https://www.510kdatabase.net/k170206/ 2017-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k170206-arthrex-fibertape-cerclage-fda-510k.jpg K170206 - Arthrex FiberTape Cerclage K170206 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Nov 2017. https://www.510kdatabase.net/k171815/ 2017-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k171815-registrado-scan-fda-510k.jpg K171815 - Registrado Scan K171815 is a FDA 510(k) cleared dental medical device. Manufacturer: Voco GmbH. Cleared Nov 2017. https://www.510kdatabase.net/k171901/ 2017-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k171901-umec-series-patient-monitors-including-fda-510k.jpg K171901 - uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S) K171901 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Nov 2017. https://www.510kdatabase.net/k173003/ 2017-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k173003-u50-diagnostic-ultrasound-system-fda-510k.jpg K173003 - U50 Diagnostic Ultrasound System K173003 is a FDA 510(k) cleared radiology medical device. Manufacturer: Edan Instruments, Inc.. Cleared Nov 2017. https://www.510kdatabase.net/k173289/ 2017-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k173289-beacon-tip-torcon-nb-advantage-fda-510k.jpg K173289 - Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter and Shuttle Select Slip-Cath Catheter, Beacon Tip Centimeter Sizing Catheter, Beacon Tip Cava Vessel Sizing Catheter, Beacon Tip White Vessel Sizing Catheter K173289 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Nov 2017. https://www.510kdatabase.net/k172531/ 2017-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k172531-biograph-mmr-with-mmr-angio-transfer-fda-510k.jpg K172531 - Biograph mMR with mMR Angio Transfer Option K172531 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2017. https://www.510kdatabase.net/k173410/ 2017-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k173410-nce-for-planmill-fda-510k.jpg K173410 - n!ce for Planmill K173410 is a FDA 510(k) cleared dental medical device. Manufacturer: Institut Straumann AG. Cleared Nov 2017. https://www.510kdatabase.net/k170524/ 2017-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k170524-access-amh-fda-510k.jpg K170524 - Access AMH K170524 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Nov 2017. https://www.510kdatabase.net/k170725/ 2017-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k170725-stryker-universal-mesh-fda-510k.jpg K170725 - Stryker Universal Mesh K170725 is a FDA 510(k) cleared neurology medical device. Manufacturer: Stryker. Cleared Nov 2017. https://www.510kdatabase.net/k170931/ 2017-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k170931-cxi-triforce-peripheral-crossing-set-fda-510k.jpg K170931 - CXI TriForce Peripheral Crossing Set K170931 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Nov 2017. https://www.510kdatabase.net/k173166/ 2017-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k173166-anthem-fracture-system-fda-510k.jpg K173166 - ANTHEM Fracture System K173166 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Nov 2017. https://www.510kdatabase.net/k173271/ 2017-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k173271-aesculap-slim-clip-applier-forceps-fda-510k.jpg K173271 - Aesculap Slim Clip Applier Forceps K173271 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Nov 2017. https://www.510kdatabase.net/k162315/ 2017-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k162315-fortify-corpectomy-spacers-fda-510k.jpg K162315 - FORTIFY Corpectomy Spacers K162315 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Nov 2017. https://www.510kdatabase.net/k171850/ 2017-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k171850-philips-ct-big-bore-fda-510k.jpg K171850 - Philips CT Big Bore K171850 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Nov 2017. https://www.510kdatabase.net/k172226/ 2017-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k172226-mx40-release-b07-fda-510k.jpg K172226 - MX40 Release B.07 K172226 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Philips Medical Systems. Cleared Nov 2017. https://www.510kdatabase.net/k172453/ 2017-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k172453-watchdog-hemostasis-valve-kit-fda-510k.jpg K172453 - WATCHDOG Hemostasis Valve Kit K172453 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Nov 2017. https://www.510kdatabase.net/k170773/ 2017-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k170773-stryker-universal-mesh-fda-510k.jpg K170773 - Stryker Universal Mesh K170773 is a FDA 510(k) cleared dental medical device. Manufacturer: Stryker. Cleared Nov 2017. https://www.510kdatabase.net/k173192/ 2017-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k173192-cerelink-icp-sensor-basic-kit-cerelink-fda-510k.jpg K173192 - CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit K173192 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Nov 2017. https://www.510kdatabase.net/k170595/ 2017-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k170595-iv-administration-sets-fda-510k.jpg K170595 - IV Administration Sets K170595 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Nov 2017. https://www.510kdatabase.net/k171365/ 2017-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k171365-arthrex-knee-systems-fda-510k.jpg K171365 - Arthrex Knee Systems K171365 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Nov 2017. https://www.510kdatabase.net/k173009/ 2017-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k173009-ncompass-nitinol-stone-extractors-fda-510k.jpg K173009 - NCompass Nitinol Stone Extractors K173009 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Nov 2017. https://www.510kdatabase.net/k172604/ 2017-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k172604-xw-100-automated-hematology-analyzer-fda-510k.jpg K172604 - XW-100 Automated Hematology Analyzer for CLIA Waived Use K172604 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sysmex America, Inc.. Cleared Nov 2017. https://www.510kdatabase.net/k172979/ 2017-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k172979-nuvasive-growth-rod-conversion-set-fda-510k.jpg K172979 - NuVasive® Growth Rod Conversion Set K172979 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Nov 2017. https://www.510kdatabase.net/k170897/ 2017-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k170897-surecan-safety-ii-needle-surecan-fda-510k.jpg K170897 - Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site K170897 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Nov 2017. https://www.510kdatabase.net/k172060/ 2017-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k172060-capio-slim-suture-capturing-device-fda-510k.jpg K172060 - Capio SLIM Suture Capturing Device K172060 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Boston Scientific Corporation. Cleared Nov 2017. https://www.510kdatabase.net/k172591/ 2017-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k172591-fixed-patient-leads-ecg-cable-model-3153-fda-510k.jpg K172591 - Fixed Patient Leads ECG Cable (Model 3153) K172591 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Nov 2017. https://www.510kdatabase.net/k172328/ 2017-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k172328-sovereign-spinal-system-fda-510k.jpg K172328 - SOVEREIGN™ Spinal System K172328 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Nov 2017. https://www.510kdatabase.net/k172757/ 2017-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k172757-valleylab-fx8-electrosurgical-platform-fda-510k.jpg K172757 - Valleylab FX8 Electrosurgical Platform K172757 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien, LLC. Cleared Nov 2017. https://www.510kdatabase.net/k173232/ 2017-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k173232-mymerlintm-mobile-application-model-fda-510k.jpg K173232 - myMerlin(TM) Mobile Application Model APP1001 K173232 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: St Jude Medical. Cleared Nov 2017. https://www.510kdatabase.net/k173341/ 2017-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k173341-vivid-e80-vivid-e90-vivid-e95-fda-510k.jpg K173341 - Vivid E80, Vivid E90, Vivid E95 K173341 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Nov 2017. https://www.510kdatabase.net/k170767/ 2017-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k170767-surgical-stainless-steel-suture-fda-510k.jpg K170767 - Surgical Stainless Steel Suture, Stainless Steel Suture K170767 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Nov 2017. https://www.510kdatabase.net/k172347/ 2017-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k172347-gmk-hinge-gmk-revision-fda-510k.jpg K172347 - GMK Hinge, GMK Revision K172347 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Nov 2017. https://www.510kdatabase.net/k172572/ 2017-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k172572-stryker-upper-face-axs-screws-and-mid-fda-510k.jpg K172572 - Stryker Upper-Face AXS screws and Mid-Face AXS screws K172572 is a FDA 510(k) cleared dental medical device. Manufacturer: Stryker. Cleared Oct 2017. https://www.510kdatabase.net/k172351/ 2017-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k172351-altivate-reverse-humeral-stem-altivate-fda-510k.jpg K172351 - AltiVate Reverse Humeral Stem, AltiVate Reverse Small Spacer, Altivate Reverse, Small Hemi-Adapter, AltiVate Reverse, Small Socket Insert K172351 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Encore Medical, L.P.. Cleared Oct 2017. https://www.510kdatabase.net/k172404/ 2017-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k172404-senobright-hd-fda-510k.jpg K172404 - SenoBright HD K172404 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Oct 2017. https://www.510kdatabase.net/k172646/ 2017-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k172646-xidf-aws801-angio-workstation-v70-fda-510k.jpg K172646 - XIDF-AWS801, Angio Workstation, V7.0 K172646 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshibamedical Systems Corporation. Cleared Oct 2017. https://www.510kdatabase.net/k162738/ 2017-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k162738-puritan-bennett-980-ventilator-system-fda-510k.jpg K162738 - Puritan Bennett 980 Ventilator System K162738 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Covidien. Cleared Oct 2017. https://www.510kdatabase.net/k171979/ 2017-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k171979-tubing-pack-fda-510k.jpg K171979 - Tubing Pack K171979 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Oct 2017. https://www.510kdatabase.net/k173122/ 2017-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k173122-abbott-architect-free-t4-fda-510k.jpg K173122 - Abbott Architect Free T4 K173122 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Oct 2017. https://www.510kdatabase.net/k171142/ 2017-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k171142-healing-cap-multi-unit-titanium-fda-510k.jpg K171142 - Healing Cap Multi-Unit Titanium K171142 is a FDA 510(k) cleared dental medical device. Manufacturer: Nobel Biocare AB. Cleared Oct 2017. https://www.510kdatabase.net/k172325/ 2017-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k172325-rhapsody-h-30-holmium-laser-system-fda-510k.jpg K172325 - Rhapsody H-30 Holmium Laser System K172325 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cook Incorporated. Cleared Oct 2017. https://www.510kdatabase.net/k172341/ 2017-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k172341-nuvasive-modulus-tlif-interbody-system-fda-510k.jpg K172341 - NuVasive® Modulus TLIF Interbody System K172341 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Oct 2017. https://www.510kdatabase.net/k172417/ 2017-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k172417-silc-fixation-system-fda-510k.jpg K172417 - SILC® Fixation System K172417 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Oct 2017. https://www.510kdatabase.net/k170293/ 2017-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k170293-emit-ii-plus-cocaine-metabolite-assay-fda-510k.jpg K170293 - Emit II Plus Cocaine Metabolite Assay K170293 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Oct 2017. https://www.510kdatabase.net/k171946/ 2017-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k171946-gel-bead-fda-510k.jpg K171946 - Gel-Bead K171946 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vascular Solutions, Inc.. Cleared Oct 2017. https://www.510kdatabase.net/k172626/ 2017-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k172626-affinity-fusion-oxygenator-with-fda-510k.jpg K172626 - Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Fusion Oxygenator with Cortiva Biosurface, Affinity Fusion Oxygenator with Cortiva BioActive Surface & Cardiotomy/Venous Reservoir K172626 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Oct 2017. https://www.510kdatabase.net/k172970/ 2017-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k172970-m7m7tm7-premiumm7-expertm7-super-fda-510k.jpg K172970 - M7/M7T/M7 Premium/M7 Expert/M7 Super Diagnostic Ultrasound K172970 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Oct 2017. https://www.510kdatabase.net/k173095/ 2017-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k173095-viper-prime-screws-viper-prime-screws-fda-510k.jpg K173095 - VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse Screws with Fenestrations K173095 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International SARL. Cleared Oct 2017. https://www.510kdatabase.net/k170320/ 2017-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k170320-alinity-c-ict-sample-diluent-fda-510k.jpg K170320 - Alinity c ICT Sample Diluent K170320 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Oct 2017. https://www.510kdatabase.net/k172307/ 2017-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k172307-dynamic-coronary-roadmap-20-fda-510k.jpg K172307 - Dynamic Coronary Roadmap 2.0 K172307 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Oct 2017. https://www.510kdatabase.net/k170317/ 2017-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k170317-alinity-i-total-hcg-reagent-kit-fda-510k.jpg K170317 - Alinity i Total ß-hCG Reagent Kit, Alinity i System K170317 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Oct 2017. https://www.510kdatabase.net/k171001/ 2017-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k171001-monosyn-quick-synthetic-absorbable-fda-510k.jpg K171001 - Monosyn Quick Synthetic Absorbable Surgical Suture K171001 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Oct 2017. https://www.510kdatabase.net/k171640/ 2017-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k171640-m-ars-acl-anatomic-ribbon-surgery-system-fda-510k.jpg K171640 - M-ARS ACL: Anatomic Ribbon Surgery System K171640 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Oct 2017. https://www.510kdatabase.net/k171996/ 2017-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k171996-truwave-disposable-pressure-transducer-fda-510k.jpg K171996 - TruWave Disposable Pressure Transducer K171996 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Oct 2017. https://www.510kdatabase.net/k172282/ 2017-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k172282-panther-fusion-paraflu-assay-fda-510k.jpg K172282 - Panther Fusion Paraflu Assay K172282 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Hologic, Inc.. Cleared Oct 2017. https://www.510kdatabase.net/k172805/ 2017-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k172805-gi-4000-electrosurgical-generator-fda-510k.jpg K172805 - gi-4000 Electrosurgical Generator K172805 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Endoscopy Group, Inc.. Cleared Oct 2017. https://www.510kdatabase.net/k163623/ 2017-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k163623-quantra-fda-510k.jpg K163623 - Quantra K163623 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hologic, Inc.. Cleared Oct 2017. https://www.510kdatabase.net/k170106/ 2017-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k170106-myknee-pps-pin-positioners-fda-510k.jpg K170106 - MyKnee PPS-Pin Positioners K170106 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Oct 2017. https://www.510kdatabase.net/k172090/ 2017-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k172090-guideliner-v3-catheter-fda-510k.jpg K172090 - GuideLiner V3 Catheter K172090 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vascular Solutions, Inc.. Cleared Oct 2017. https://www.510kdatabase.net/k172352/ 2017-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k172352-trefoil-system-fda-510k.jpg K172352 - TREFOIL System K172352 is a FDA 510(k) cleared dental medical device. Manufacturer: Nobel Biocare AB. Cleared Oct 2017. https://www.510kdatabase.net/k170316/ 2017-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k170316-alinity-c-glucose-reagent-kit-alinity-fda-510k.jpg K170316 - ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM K170316 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Oct 2017. https://www.510kdatabase.net/k172527/ 2017-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k172527-amplatz-renal-dilator-set-catheter-for-fda-510k.jpg K172527 - Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set, Amplatz Dilator, Amplatz Renal Introducer, Amplatz Radiopaque TFE Sheath, Clear Amplatz Sheath with Radiopaque Stripe K172527 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Oct 2017. https://www.510kdatabase.net/k170298/ 2017-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k170298-liberator-beacon-tip-locking-stylet-fda-510k.jpg K170298 - Liberator Beacon Tip Locking Stylet K170298 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Oct 2017. https://www.510kdatabase.net/k171579/ 2017-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k171579-m6m6tm6-expm6sm6-prom5-expm55m58-fda-510k.jpg K171579 - M6/M6T/M6 EXP/M6S/M6 PRO/M5 EXP/M55/M58 Diagnostic Ultrasound System K171579 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Oct 2017. https://www.510kdatabase.net/k172034/ 2017-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k172034-stryker-spine-navigation-system-with-fda-510k.jpg K172034 - Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato Tap K172034 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Corporation. Cleared Oct 2017. https://www.510kdatabase.net/k172910/ 2017-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k172910-emit-ii-plus-oxycodone-assay-fda-510k.jpg K172910 - Emit II Plus Oxycodone Assay K172910 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Oct 2017. https://www.510kdatabase.net/k172940/ 2017-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k172940-anchor-tissue-retrieval-system-fda-510k.jpg K172940 - ANCHOR Tissue Retrieval System K172940 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Conmed Corporation. Cleared Oct 2017. https://www.510kdatabase.net/k172817/ 2017-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k172817-4k-camera-head-olympus-ch-s400-xz-eb-fda-510k.jpg K172817 - 4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB, 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA K172817 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Oct 2017. https://www.510kdatabase.net/k172537/ 2017-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k172537-codman-eds-3-csf-external-drainage-fda-510k.jpg K172537 - Codman EDS 3 CSF External Drainage System, Codman EDS 3 CSF External Drainage System Collection Bag K172537 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Oct 2017. https://www.510kdatabase.net/k171548/ 2017-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k171548-cotton-graduated-dilation-catheter-fda-510k.jpg K171548 - Cotton Graduated Dilation Catheter, Fusion Biliary Dilation Catheter, Soehendra Biliary Dilation Catheter, Geenen Graduated Dilation Catheter K171548 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Wilson-Cook Medical, Inc.. Cleared Oct 2017. https://www.510kdatabase.net/k171916/ 2017-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k171916-single-use-hot-biopsy-forceps-fd-231-fda-510k.jpg K171916 - Single Use Hot Biopsy Forceps FD-231 K171916 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Oct 2017. https://www.510kdatabase.net/k170840/ 2017-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k170840-magnetom-terra-fda-510k.jpg K170840 - MAGNETOM Terra K170840 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 2017. https://www.510kdatabase.net/k172305/ 2017-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k172305-cs100cs100i-intra-aortic-balloon-pump-fda-510k.jpg K172305 - CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon Pump K172305 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Oct 2017. https://www.510kdatabase.net/k172123/ 2017-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k172123-nuvasive-modulus-xlif-interbody-system-fda-510k.jpg K172123 - NuVasive® Modulus XLIF Interbody System K172123 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Oct 2017. https://www.510kdatabase.net/k171373/ 2017-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k171373-3m-bair-hugger-model-675-total-fda-510k.jpg K171373 - 3M Bair Hugger Model 675 Total Temperature Management System K171373 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: 3M Company. Cleared Oct 2017. https://www.510kdatabase.net/k172724/ 2017-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k172724-xia-45-spinal-system-power-adaptor-fda-510k.jpg K172724 - XIA® 4.5 Spinal System, Power Adaptor Instrument Accessory K172724 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Corporation. Cleared Oct 2017. https://www.510kdatabase.net/k172406/ 2017-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k172406-ingenuity-tf-fda-510k.jpg K172406 - Ingenuity TF K172406 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Oct 2017. https://www.510kdatabase.net/k170452/ 2017-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k170452-medacta-shoulder-system-fda-510k.jpg K170452 - Medacta Shoulder System K170452 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Oct 2017. https://www.510kdatabase.net/k171689/ 2017-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k171689-artic-l-3d-ti-spinal-system-with-fda-510k.jpg K171689 - ARTiC-L 3D Ti Spinal System with TiONIC Technology, ARTiC-XL 3D Ti Spinal System with TiONIC Technology K171689 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Oct 2017. https://www.510kdatabase.net/k172089/ 2017-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k172089-prolene-soft-polypropylene-mesh-fda-510k.jpg K172089 - PROLENE Soft Polypropylene Mesh K172089 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Oct 2017. https://www.510kdatabase.net/k172408/ 2017-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k172408-biomet-bone-cement-r-fda-510k.jpg K172408 - Biomet Bone Cement R K172408 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Oct 2017. https://www.510kdatabase.net/k172558/ 2017-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k172558-ivas-8g-bone-biopsy-kit-ivas-11g-bone-fda-510k.jpg K172558 - iVAS 8g Bone Biopsy Kit, iVAS 11g Bone Biopsy Kit, iVAS 10g Bone Biopsy Kit K172558 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Stryker Corporation. Cleared Oct 2017. https://www.510kdatabase.net/k171991/ 2017-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k171991-empowr-porous-knee-system-fda-510k.jpg K171991 - EMPOWR Porous Knee System K171991 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Encore Medical, L.P.. Cleared Oct 2017. https://www.510kdatabase.net/k172174/ 2017-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k172174-philips-intellisite-pathology-solution-fda-510k.jpg K172174 - Philips IntelliSite Pathology Solution K172174 is a FDA 510(k) cleared pathology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Oct 2017. https://www.510kdatabase.net/k172520/ 2017-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k172520-cre-rx-biliary-balloon-dilatation-fda-510k.jpg K172520 - CRE RX Biliary Balloon Dilatation Catheter K172520 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Oct 2017. https://www.510kdatabase.net/k172671/ 2017-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k172671-helixar-electrosurgical-generator-with-fda-510k.jpg K172671 - HelixAR Electrosurgical Generator with Argon Beam Coagulation, HelixAR Mobile Pedestal K172671 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Conmed Corporation. Cleared Oct 2017. https://www.510kdatabase.net/k172691/ 2017-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k172691-ultrasonic-generator-fda-510k.jpg K172691 - Ultrasonic Generator K172691 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Oct 2017. https://www.510kdatabase.net/k172022/ 2017-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k172022-codman-hydrocephalus-valves-catheters-fda-510k.jpg K172022 - CODMAN Hydrocephalus Valves, Catheters & Accessories (Bundled) K172022 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Oct 2017. https://www.510kdatabase.net/k172621/ 2017-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k172621-hardydisk-meropenemvaborbactam-2010g-fda-510k.jpg K172621 - HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30) K172621 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Hardy Diagnostics. Cleared Oct 2017. https://www.510kdatabase.net/k172684/ 2017-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k172684-smith-nephew-inc-anthology-afit-hip-stem-fda-510k.jpg K172684 - Smith & Nephew, Inc. ANTHOLOGY™ AFIT Hip Stem K172684 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 2017. https://www.510kdatabase.net/k171978/ 2017-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k171978-combo-stimulator-mt9000-combo-fda-510k.jpg K171978 - Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10 K171978 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Shenzhen Dongdixin Technology Co., Ltd.. Cleared Oct 2017. https://www.510kdatabase.net/k172342/ 2017-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k172342-voluson-e6-voluson-e8-voluson-e10-fda-510k.jpg K172342 - Voluson E6, Voluson E8, Voluson E10 K172342 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Sep 2017. https://www.510kdatabase.net/k172380/ 2017-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k172380-u2-diagnostic-ultrasound-system-fda-510k.jpg K172380 - U2 Diagnostic Ultrasound System K172380 is a FDA 510(k) cleared radiology medical device. Manufacturer: Edan Instruments, Inc.. Cleared Sep 2017. https://www.510kdatabase.net/k172397/ 2017-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k172397-sherlock-3cg-tip-positioning-system-fda-510k.jpg K172397 - Sherlock 3CG Tip Positioning System Stylet K172397 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Sep 2017. https://www.510kdatabase.net/k170020/ 2017-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k170020-peel-away-introducer-set-fda-510k.jpg K170020 - Peel-Away Introducer Set K170020 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Sep 2017. https://www.510kdatabase.net/k171212/ 2017-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k171212-airfit-n20-fda-510k.jpg K171212 - AirFit N20 K171212 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Resmed, Ltd.. Cleared Sep 2017. https://www.510kdatabase.net/k171633/ 2017-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k171633-nuvasive-tlx-interbody-system-fda-510k.jpg K171633 - NuVasive TLX Interbody System K171633 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Sep 2017. https://www.510kdatabase.net/k171894/ 2017-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k171894-nuvasive-precept-spinal-system-fda-510k.jpg K171894 - NuVasive® Precept™ Spinal System K171894 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Sep 2017. https://www.510kdatabase.net/k170816/ 2017-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k170816-elements-image-fusion-elements-cranial-fda-510k.jpg K170816 - Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM K170816 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab AG. Cleared Sep 2017. https://www.510kdatabase.net/k171107/ 2017-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k171107-capstone-control-spinal-system-fda-510k.jpg K171107 - CAPSTONE CONTROL Spinal System, CAPSTONE CONTROL PTC Spinal System K171107 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Sep 2017. https://www.510kdatabase.net/k171963/ 2017-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k171963-panther-fusion-flu-abrsv-assay-panther-fda-510k.jpg K171963 - Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion Assay Fluids I-S Kit, Panther Fusion Specimen Lysis Tubes K171963 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Hologic, Inc.. Cleared Sep 2017. https://www.510kdatabase.net/k171992/ 2017-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k171992-sculpsure-fda-510k.jpg K171992 - SculpSure K171992 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cynosure, Inc.. Cleared Sep 2017. https://www.510kdatabase.net/k170157/ 2017-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k170157-independence-spacers-fda-510k.jpg K170157 - INDEPENDENCE® Spacers K170157 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Sep 2017. https://www.510kdatabase.net/k171862/ 2017-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k171862-galaxy-g3-mini-microcoil-delivery-system-fda-510k.jpg K171862 - GALAXY G3 Mini Microcoil Delivery System K171862 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Sep 2017. https://www.510kdatabase.net/k171943/ 2017-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k171943-electrocardiograph-fda-510k.jpg K171943 - Electrocardiograph K171943 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edan Instruments, Inc.. Cleared Sep 2017. https://www.510kdatabase.net/k162848/ 2017-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k162848-straumann-cares-golden-titin-abutments-fda-510k.jpg K162848 - Straumann CARES Golden Ti/TiN Abutments K162848 is a FDA 510(k) cleared dental medical device. Manufacturer: Institut Straumann AG. Cleared Sep 2017. https://www.510kdatabase.net/k170956/ 2017-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k170956-system-1e-liquid-chemical-sterilant-fda-510k.jpg K170956 - SYSTEM 1E Liquid Chemical Sterilant Processing System K170956 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Sep 2017. https://www.510kdatabase.net/k171262/ 2017-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k171262-tempsure-fda-510k.jpg K171262 - TempSure K171262 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cynosure, Inc.. Cleared Sep 2017. https://www.510kdatabase.net/k170641/ 2017-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k170641-da-vinci-ssi-endoscopes-da-vinci-xi-fda-510k.jpg K170641 - da Vinci S/Si Endoscopes, da Vinci Xi Endoscopes K170641 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Sep 2017. https://www.510kdatabase.net/k170879/ 2017-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k170879-is4000-stapler-45-instrument-and-its-fda-510k.jpg K170879 - IS4000 Stapler 45 Instrument and its Reusable Accessories, IS4000 EndoWrist Stapler 30 Instrument, IS3000 Stapler 45 Instrument and its Reusable Accessories K170879 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Sep 2017. https://www.510kdatabase.net/k171852/ 2017-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k171852-darco-locking-bone-plate-system-fda-510k.jpg K171852 - DARCO Locking Bone Plate System K171852 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Sep 2017. https://www.510kdatabase.net/k171891/ 2017-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k171891-zs3-ultrasound-system-zone-pro-fda-510k.jpg K171891 - ZS3 Ultrasound System, z.one pro Ultrasound System K171891 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Sep 2017. https://www.510kdatabase.net/k170292/ 2017-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k170292-tri-ex-extraction-balloon-with-fda-510k.jpg K170292 - Tri-Ex Extraction Balloon With Multiple Sizing K170292 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Wilson-Cook Medical, Inc.. Cleared Sep 2017. https://www.510kdatabase.net/k172247/ 2017-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k172247-magic3-go-intermittent-urinary-catheter-fda-510k.jpg K172247 - Magic3 Go Intermittent Urinary Catheter K172247 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Sep 2017. https://www.510kdatabase.net/k172566/ 2017-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k172566-myosure-hysteroscopic-tissue-removal-fda-510k.jpg K172566 - Myosure Hysteroscopic Tissue Removal System and Myosure Tissue Removal Devices K172566 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Hologic, Inc.. Cleared Sep 2017. https://www.510kdatabase.net/k170002/ 2017-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k170002-medline-blood-collection-set-fda-510k.jpg K170002 - Medline Blood Collection Set K170002 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Sep 2017. https://www.510kdatabase.net/k171632/ 2017-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k171632-da-vinci-xi-surgical-system-fda-510k.jpg K171632 - da Vinci Xi Surgical System K171632 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Sep 2017. https://www.510kdatabase.net/k172199/ 2017-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k172199-elevate-spinal-system-capstone-ptc-fda-510k.jpg K172199 - ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System Titanium K172199 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Sep 2017. https://www.510kdatabase.net/k172587/ 2017-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k172587-mecta-c-with-titanium-markers-and-fda-510k.jpg K172587 - Mecta-C with titanium markers and Mecta-C TiPEEK with titanium markers K172587 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Sep 2017. https://www.510kdatabase.net/k170640/ 2017-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k170640-endoscope-sterilization-tray-fda-510k.jpg K170640 - Endoscope Sterilization Tray K170640 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Sep 2017. https://www.510kdatabase.net/k172506/ 2017-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k172506-bd-cathena-safety-iv-catheter-fda-510k.jpg K172506 - BD Cathena Safety IV Catheter K172506 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson and Company. Cleared Sep 2017. https://www.510kdatabase.net/k170231/ 2017-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k170231-ihealth-align-gluco-monitoring-system-fda-510k.jpg K170231 - iHealth Align Gluco-Monitoring System (BG1) K170231 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Andon Health Co, Ltd.. Cleared Sep 2017. https://www.510kdatabase.net/k171840/ 2017-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k171840-stryker-consolidated-operating-room-fda-510k.jpg K171840 - Stryker Consolidated Operating Room Equipment (CORE) 2 Console K171840 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Stryker Corporation. Cleared Sep 2017. https://www.510kdatabase.net/k172150/ 2017-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k172150-etest-ceftazidimeavibactam-cza-0016-fda-510k.jpg K172150 - Etest Ceftazidime/Avibactam (CZA) (0.016 - 256 ug/mL) K172150 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Sep 2017. https://www.510kdatabase.net/k170168/ 2017-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k170168-masimo-rad-97-and-accessories-fda-510k.jpg K170168 - Masimo Rad-97 and Accessories K170168 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Masimo Corporation. Cleared Sep 2017. https://www.510kdatabase.net/k170323/ 2017-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k170323-entuit-start-initial-placement-fda-510k.jpg K170323 - Entuit Start Initial Placement Gastrostomy Set K170323 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Sep 2017. https://www.510kdatabase.net/k170937/ 2017-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k170937-viper-prime-navigated-inserter-fda-510k.jpg K170937 - VIPER PRIME navigated inserter K170937 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International SARL. Cleared Sep 2017. https://www.510kdatabase.net/k171832/ 2017-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k171832-rangedenalimesa-spinal-system-fda-510k.jpg K171832 - Range/Denali/Mesa Spinal System K171832 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: K2m, Inc.. Cleared Sep 2017. https://www.510kdatabase.net/k171664/ 2017-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k171664-hemoglobin-variants-system-on-newborn-fda-510k.jpg K171664 - Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software K171664 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bio-Rad Laboratories, Inc.. Cleared Sep 2017. https://www.510kdatabase.net/k170875/ 2017-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k170875-da-vinci-si-single-site-instruments-fda-510k.jpg K170875 - da Vinci Si Single-Site Instruments and Accessories, da Vinci Xi Single-Site Instruments and Accessories K170875 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Sep 2017. https://www.510kdatabase.net/k170644/ 2017-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k170644-da-vinci-ssi-endowrist-instruments-and-fda-510k.jpg K170644 - da Vinci S/Si EndoWrist Instruments and Accessories, Harmonic ACE Curved Shears (5mm & 8mm) K170644 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Sep 2017. https://www.510kdatabase.net/k170645/ 2017-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k170645-da-vinci-xi-endowrist-instruments-and-fda-510k.jpg K170645 - da Vinci Xi EndoWrist Instruments and Accessories K170645 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Sep 2017. https://www.510kdatabase.net/k171067/ 2017-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k171067-invision-total-ankle-revision-system-fda-510k.jpg K171067 - INVISION Total Ankle Revision System K171067 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Sep 2017. https://www.510kdatabase.net/k172117/ 2017-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k172117-prelude-pursuit-splittable-sheath-fda-510k.jpg K172117 - Prelude Pursuit Splittable Sheath Introducer K172117 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Sep 2017. https://www.510kdatabase.net/k170415/ 2017-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k170415-medline-hemo-force-dvt-compression-fda-510k.jpg K170415 - Medline Hemo-Force DVT Compression Sleeve K170415 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medline Industries, Inc.. Cleared Sep 2017. https://www.510kdatabase.net/k170854/ 2017-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k170854-hemosil-acustar-hit-iggpf4-h-hemosil-fda-510k.jpg K170854 - HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls K170854 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 2017. https://www.510kdatabase.net/k171725/ 2017-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k171725-cufflink-implant-system-fda-510k.jpg K171725 - CuffLink Implant System K171725 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Conmed Corporation. Cleared Sep 2017. https://www.510kdatabase.net/k163538/ 2017-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k163538-quanta-flash-lkm-1-reagents-quanta-fda-510k.jpg K163538 - QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls K163538 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Sep 2017. https://www.510kdatabase.net/k171178/ 2017-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k171178-central-monitoring-system-fda-510k.jpg K171178 - Central Monitoring System K171178 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Edan Instruments, Inc.. Cleared Sep 2017. https://www.510kdatabase.net/k171496/ 2017-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k171496-tritanium-c-anterior-cervical-cage-fda-510k.jpg K171496 - Tritanium C Anterior Cervical Cage K171496 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Spine. Cleared Sep 2017. https://www.510kdatabase.net/k163525/ 2017-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k163525-quanta-flash-m2-mit3-quanta-flash-m2-fda-510k.jpg K163525 - QUANTA Flash M2 (MIT3), QUANTA Flash M2 (MIT3) Calibrators, QUANTA Flash M2 (MIT3) Controls K163525 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Sep 2017. https://www.510kdatabase.net/k163302/ 2017-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k163302-senographe-pristina-fda-510k.jpg K163302 - Senographe Pristina K163302 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Sep 2017. https://www.510kdatabase.net/k170547/ 2017-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k170547-arthrex-mesh-plate-system-fda-510k.jpg K170547 - Arthrex Mesh Plate System K170547 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Sep 2017. https://www.510kdatabase.net/k162533/ 2017-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k162533-kelowna-gyn-and-crook-prostate-templates-fda-510k.jpg K162533 - Kelowna GYN and Crook Prostate Templates K162533 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Aug 2017. https://www.510kdatabase.net/k171570/ 2017-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k171570-additional-viper-prime-screws-with-fda-510k.jpg K171570 - Additional VIPER PRIME™ screws with fenestrations K171570 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International SARL. Cleared Aug 2017. https://www.510kdatabase.net/k171642/ 2017-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k171642-atellica-im-ferritin-assay-fda-510k.jpg K171642 - Atellica IM Ferritin Assay K171642 is a FDA 510(k) cleared immunology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Aug 2017. https://www.510kdatabase.net/k171540/ 2017-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k171540-refobacin-bone-cement-r-fda-510k.jpg K171540 - Refobacin Bone Cement R K171540 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Aug 2017. https://www.510kdatabase.net/k171592/ 2017-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k171592-crossft-knotless-biocomposite-suture-fda-510k.jpg K171592 - CrossFT™ Knotless Biocomposite Suture Anchor with Disposable Driver K171592 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Conmed Corporation. Cleared Aug 2017. https://www.510kdatabase.net/k170010/ 2017-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k170010-salle-intraoperative-pyeloplasty-stent-fda-510k.jpg K170010 - Salle Intraoperative Pyeloplasty Stent Set K170010 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Aug 2017. https://www.510kdatabase.net/k172131/ 2017-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k172131-2-hole-lateral-plating-system-fda-510k.jpg K172131 - 2 Hole Lateral Plating System K172131 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Aug 2017. https://www.510kdatabase.net/k170750/ 2017-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k170750-rt-elements-cranial-srs-spine-srs-fda-510k.jpg K170750 - RT Elements, Cranial SRS, Spine SRS, Multiple Brain Mets SRS, RT QA, Adaptive Hybrid Surgery Analysis, Dose Review K170750 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab AG. Cleared Aug 2017. https://www.510kdatabase.net/k171465/ 2017-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k171465-stryker-self-punching-iconix-fda-510k.jpg K171465 - Stryker Self-Punching ICONIX K171465 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker. Cleared Aug 2017. https://www.510kdatabase.net/k171853/ 2017-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k171853-liver-access-and-biopsy-sets-fda-510k.jpg K171853 - Liver Access and Biopsy Sets K171853 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Aug 2017. https://www.510kdatabase.net/k171921/ 2017-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k171921-venacure-evlt-nevertouch-procedure-kit-fda-510k.jpg K171921 - VenaCure EVLT NeverTouch Procedure Kit K171921 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: AngioDynamics, Inc.. Cleared Aug 2017. https://www.510kdatabase.net/k170876/ 2017-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k170876-passport-series-patient-fda-510k.jpg K170876 - Passport Series Patient Monitors(Passport 12m, Passport 17m) K170876 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Aug 2017. https://www.510kdatabase.net/k172104/ 2017-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k172104-ozarktm-cervical-plate-system-fda-510k.jpg K172104 - Ozark(tm) Cervical Plate System K172104 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: K2m, Inc.. Cleared Aug 2017. https://www.510kdatabase.net/k172262/ 2017-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k172262-evos-small-fragment-plating-system-fda-510k.jpg K172262 - EVOS Small Fragment Plating System K172262 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Aug 2017. https://www.510kdatabase.net/k163342/ 2017-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k163342-i-stat-hematocrit-test-with-i-stat-fda-510k.jpg K163342 - i-STAT Hematocrit test with i-STAT Alinity System K163342 is a FDA 510(k) cleared hematology medical device. Manufacturer: Abbott Laboratories. Cleared Aug 2017. https://www.510kdatabase.net/k170642/ 2017-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k170642-gravity-soft-tissue-repair-system-fda-510k.jpg K170642 - GRAVITY™ Soft Tissue Repair System K170642 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Aug 2017. https://www.510kdatabase.net/k171504/ 2017-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k171504-verify-assert-vh2o2-self-contained-fda-510k.jpg K171504 - VERIFY Assert VH2O2 Self-Contained Biological Indicator K171504 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Aug 2017. https://www.510kdatabase.net/k171587/ 2017-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k171587-verify-incubator-for-assert-vh2o2-self-fda-510k.jpg K171587 - VERIFY Incubator for Assert VH2O2 Self-Contained Biological Indicator K171587 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Aug 2017. https://www.510kdatabase.net/k172367/ 2017-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k172367-stryker-integrated-bipolar-cord-and-fda-510k.jpg K172367 - Stryker Integrated Bipolar Cord and Tubing Sets K172367 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Stryker Instruments. Cleared Aug 2017. https://www.510kdatabase.net/k163375/ 2017-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k163375-infinity-oct-system-fda-510k.jpg K163375 - INFINITY™ OCT System K163375 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Aug 2017. https://www.510kdatabase.net/k171452/ 2017-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k171452-mamba-and-mamba-flex-microcatheters-fda-510k.jpg K171452 - MAMBA and MAMBA FLEX Microcatheters K171452 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Aug 2017. https://www.510kdatabase.net/k171897/ 2017-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k171897-approach-cto-microwire-guide-fda-510k.jpg K171897 - Approach CTO Microwire Guide K171897 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Aug 2017. https://www.510kdatabase.net/k170149/ 2017-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k170149-3dmetal-tibial-cones-fda-510k.jpg K170149 - 3DMetal Tibial Cones K170149 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Aug 2017. https://www.510kdatabase.net/k170782/ 2017-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k170782-medline-unite-snap-off-screws-fda-510k.jpg K170782 - Medline UNITE® Snap-Off Screws K170782 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medline Industries, Inc.. Cleared Aug 2017. https://www.510kdatabase.net/k170800/ 2017-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k170800-nuvasive-lessray-with-enhanced-tracking-fda-510k.jpg K170800 - NuVasive LessRay with Enhanced Tracking K170800 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Aug 2017. https://www.510kdatabase.net/k171900/ 2017-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k171900-acclarix-ax4-diagnostic-ultrasound-fda-510k.jpg K171900 - Acclarix AX4 Diagnostic Ultrasound System K171900 is a FDA 510(k) cleared radiology medical device. Manufacturer: Edan Instruments, Inc.. Cleared Aug 2017. https://www.510kdatabase.net/k171475/ 2017-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k171475-deroyal-laprador-specimen-retrieval-fda-510k.jpg K171475 - DeRoyal Laprador Specimen Retrieval System K171475 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Deroyal Industries, Inc.. Cleared Aug 2017. https://www.510kdatabase.net/k172204/ 2017-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k172204-bd-intima-ii-plus-closed-iv-catheter-fda-510k.jpg K172204 - BD Intima II PLUS Closed IV Catheter System K172204 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson and Company. Cleared Aug 2017. https://www.510kdatabase.net/k170910/ 2017-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k170910-medacta-anatomic-shoulder-prosthesis-fda-510k.jpg K170910 - Medacta Anatomic Shoulder Prosthesis K170910 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Aug 2017. https://www.510kdatabase.net/k170968/ 2017-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k170968-prophecy-invision-pre-operative-fda-510k.jpg K170968 - PROPHECY INVISION Pre-operative Navigation System K170968 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Aug 2017. https://www.510kdatabase.net/k171651/ 2017-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k171651-excelsius-gps-fda-510k.jpg K171651 - EXCELSIUS GPS K171651 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Aug 2017. https://www.510kdatabase.net/k170222/ 2017-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k170222-rapid-tox-cup-ii-fda-510k.jpg K170222 - Rapid Tox Cup II K170222 is a FDA 510(k) cleared toxicology medical device. Manufacturer: American Bio Medica Corp.. Cleared Aug 2017. https://www.510kdatabase.net/k172163/ 2017-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k172163-eclipse-treatment-planning-system-fda-510k.jpg K172163 - Eclipse Treatment Planning System K172163 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Aug 2017. https://www.510kdatabase.net/k172374/ 2017-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k172374-acuson-nx2-diagnostic-ultrasound-fda-510k.jpg K172374 - ACUSON NX2 Diagnostic Ultrasound System, ACUSON NX2 Elite Diagnostic Ultrasound System K172374 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 2017. https://www.510kdatabase.net/k170321/ 2017-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k170321-3m-comply-hydrogen-peroxide-chemical-fda-510k.jpg K170321 - 3M Comply Hydrogen Peroxide Chemical Indicator 1248 K170321 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Aug 2017. https://www.510kdatabase.net/k171332/ 2017-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k171332-artemis-neuro-evacuation-device-fda-510k.jpg K171332 - Artemis Neuro Evacuation Device K171332 is a FDA 510(k) cleared neurology medical device. Manufacturer: Penumbra, Inc.. Cleared Aug 2017. https://www.510kdatabase.net/k162729/ 2017-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k162729-aintree-intubation-catheter-arndt-fda-510k.jpg K162729 - Aintree Intubation Catheter, Arndt Airway Exchange Catheter Set, Cook Airway Exchange Catheter, and Cook Airway Exchange Catheter - Extra Firm With Soft Tip K162729 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Cook Incorporated. Cleared Aug 2017. https://www.510kdatabase.net/k162977/ 2017-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k162977-advia-2120i-advia-2120-fda-510k.jpg K162977 - ADVIA 2120i, ADVIA 2120 K162977 is a FDA 510(k) cleared hematology medical device. Manufacturer: Siemens Healthcare Diagnostics. Cleared Aug 2017. https://www.510kdatabase.net/k170492/ 2017-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k170492-xtag-cyp2d6-kit-v3-fda-510k.jpg K170492 - xTAG CYP2D6 Kit v3 K170492 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Luminex Molecular Diagnostics, Inc.. Cleared Aug 2017. https://www.510kdatabase.net/k171200/ 2017-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k171200-grandio-blocs-fda-510k.jpg K171200 - Grandio blocs K171200 is a FDA 510(k) cleared dental medical device. Manufacturer: Voco GmbH. Cleared Aug 2017. https://www.510kdatabase.net/k172114/ 2017-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k172114-zimmer-natural-nail-system-fda-510k.jpg K172114 - Zimmer Natural Nail System K172114 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Aug 2017. https://www.510kdatabase.net/k171809/ 2017-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k171809-epic-biliary-endoscopic-stent-system-fda-510k.jpg K171809 - Epic Biliary Endoscopic Stent System K171809 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Aug 2017. https://www.510kdatabase.net/k170845/ 2017-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k170845-minimax-fda-510k.jpg K170845 - MiniMAX K170845 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Aug 2017. https://www.510kdatabase.net/k171444/ 2017-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k171444-yukon-oct-spinal-system-fda-510k.jpg K171444 - YUKON OCT Spinal System K171444 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: K2m, Inc.. Cleared Aug 2017. https://www.510kdatabase.net/k171735/ 2017-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k171735-powerloc-max-power-injectable-infusion-fda-510k.jpg K171735 - PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set K171735 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Aug 2017. https://www.510kdatabase.net/k171362/ 2017-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k171362-merit-syringe-fda-510k.jpg K171362 - Merit Syringe K171362 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Aug 2017. https://www.510kdatabase.net/k171147/ 2017-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k171147-reveal-bulk-fda-510k.jpg K171147 - REVEAL Bulk K171147 is a FDA 510(k) cleared dental medical device. Manufacturer: Bisco, Inc.. Cleared Aug 2017. https://www.510kdatabase.net/k171596/ 2017-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k171596-echo-3-22-echotip-ultra-and-eusn-1-fda-510k.jpg K171596 - ECHO-3-22: Echotip Ultra and EUSN-1, EUSN-3: Echotip Ultrasound Needle K171596 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Wilson-Cook Medical, Inc.. Cleared Aug 2017. https://www.510kdatabase.net/k172081/ 2017-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k172081-maestro-microcatheter-fda-510k.jpg K172081 - Maestro Microcatheter K172081 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Aug 2017. https://www.510kdatabase.net/k170919/ 2017-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k170919-the-tibow-expandable-spacer-system-fda-510k.jpg K170919 - The TiBow Expandable Spacer System K170919 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Aug 2017. https://www.510kdatabase.net/k163704/ 2017-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k163704-healgen-multi-drug-urine-test-cup-fda-510k.jpg K163704 - Healgen Multi-Drug Urine Test Cup K163704 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Healgen Scientific, LLC. Cleared Aug 2017. https://www.510kdatabase.net/k171595/ 2017-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k171595-must-sacral-iliac-screw-and-pelvic-fda-510k.jpg K171595 - M.U.S.T. Sacral Iliac Screw and Pelvic Trauma System K171595 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Aug 2017. https://www.510kdatabase.net/k171717/ 2017-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k171717-autocon-iii-400-fda-510k.jpg K171717 - AUTOCON III 400 K171717 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Aug 2017. https://www.510kdatabase.net/k171062/ 2017-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k171062-bp5s-wireless-blood-pressure-monitor-fda-510k.jpg K171062 - BP5S Wireless Blood Pressure Monitor K171062 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Andon Health Co, Ltd.. Cleared Aug 2017. https://www.510kdatabase.net/k171369/ 2017-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k171369-must-mini-posterior-cervical-screws-fda-510k.jpg K171369 - M.U.S.T. MINI Posterior Cervical Screws System K171369 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Aug 2017. https://www.510kdatabase.net/k171758/ 2017-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k171758-must-combined-set-screws-fda-510k.jpg K171758 - M.U.S.T. Combined Set Screws K171758 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Aug 2017. https://www.510kdatabase.net/k171975/ 2017-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k171975-hardydisk-ast-delafloxacin-5-g-dlx5-fda-510k.jpg K171975 - HardyDisk AST Delafloxacin 5 µg (DLX5) K171975 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Hardy Diagnostics. Cleared Aug 2017. https://www.510kdatabase.net/k171999/ 2017-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k171999-performer-introducer-fda-510k.jpg K171999 - Performer Introducer K171999 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Jul 2017. https://www.510kdatabase.net/k171054/ 2017-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k171054-biomet-knee-joint-replacement-prostheses-fda-510k.jpg K171054 - Biomet Knee Joint Replacement Prostheses K171054 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jul 2017. https://www.510kdatabase.net/k171602/ 2017-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k171602-williams-cystoscopic-injection-needle-fda-510k.jpg K171602 - Williams Cystoscopic Injection Needle K171602 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Jul 2017. https://www.510kdatabase.net/k171699/ 2017-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k171699-da-vinci-xi-surgical-system-da-vinci-fda-510k.jpg K171699 - da Vinci Xi Surgical System, da Vinci Si Surgical System, da Vinci X Surgical System K171699 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Jul 2017. https://www.510kdatabase.net/k172013/ 2017-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k172013-vitalbeam-fda-510k.jpg K172013 - VitalBeam K172013 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Jul 2017. https://www.510kdatabase.net/k163031/ 2017-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k163031-bunegin-albin-air-aspiration-set-fda-510k.jpg K163031 - Bunegin-Albin Air Aspiration Set K163031 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Jul 2017. https://www.510kdatabase.net/k163597/ 2017-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k163597-vaclok-at-vacuum-syringe-fda-510k.jpg K163597 - VacLok AT Vacuum Syringe K163597 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jul 2017. https://www.510kdatabase.net/k170563/ 2017-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k170563-3m-comply-hydrogen-peroxide-indicator-fda-510k.jpg K170563 - 3M Comply Hydrogen Peroxide Indicator Tape K170563 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Jul 2017. https://www.510kdatabase.net/k171282/ 2017-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k171282-fully-automatic-blood-pressure-monitor-fda-510k.jpg K171282 - Fully Automatic Blood Pressure Monitor K171282 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Andon Health Co, Ltd.. Cleared Jul 2017. https://www.510kdatabase.net/k170600/ 2017-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k170600-carto-3-ep-navigation-system-version-fda-510k.jpg K170600 - CARTO 3 EP Navigation System, Version 6.0 and Accessories K170600 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biosense Webster, Inc.. Cleared Jul 2017. https://www.510kdatabase.net/k171913/ 2017-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k171913-rubicon-14-18-and-35-support-catheters-fda-510k.jpg K171913 - Rubicon 14, 18 and 35 Support Catheters K171913 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Jul 2017. https://www.510kdatabase.net/k171364/ 2017-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k171364-mp-lefort-i-plates-fda-510k.jpg K171364 - MP LeFort I Plates K171364 is a FDA 510(k) cleared dental medical device. Manufacturer: Stryker. Cleared Jul 2017. https://www.510kdatabase.net/k162950/ 2017-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k162950-vitek-ms-fda-510k.jpg K162950 - VITEK MS K162950 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jul 2017. https://www.510kdatabase.net/k170532/ 2017-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k170532-true-form-reshapable-guide-wire-fda-510k.jpg K170532 - True Form Reshapable Guide Wire K170532 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jul 2017. https://www.510kdatabase.net/k170832/ 2017-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k170832-ultimax-i-drex-ui80-v160-fda-510k.jpg K170832 - Ultimax-i, DREX-UI80 V1.60 K170832 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshibamedical Systems Corporation. Cleared Jul 2017. https://www.510kdatabase.net/k171003/ 2017-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k171003-3m-attest-rapid-readout-biological-fda-510k.jpg K171003 - 3M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader K171003 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Jul 2017. https://www.510kdatabase.net/k171597/ 2017-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k171597-vantage-elan-15t-v40-fda-510k.jpg K171597 - Vantage Elan 1.5T, V4.0 K171597 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshibamedical Systems Corporation. Cleared Jul 2017. https://www.510kdatabase.net/k170326/ 2017-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k170326-dynamx-intramedullary-implant-fda-510k.jpg K170326 - dynaMX Intramedullary Implant K170326 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jul 2017. https://www.510kdatabase.net/k171425/ 2017-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k171425-concorde-lift-fda-510k.jpg K171425 - CONCORDE LIFT K171425 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International SARL. Cleared Jul 2017. https://www.510kdatabase.net/k171439/ 2017-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k171439-eagle-plus-anterior-cervical-plate-fda-510k.jpg K171439 - EAGLE Plus Anterior Cervical Plate System, EAGLE Plus Micro Anterior Cervical Plate System, PULSE Anterior Cervical Plate System, SKYLINE Anterior Cervical Plate System, SLIM LOC Anterior Cervical Plate System, SWIFT Plus Anterior Cervical Plate System, UNIPLATE Anterior Cervical Plate System, UNIPLATE 2 Anterior Cervical Plate System K171439 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International SARL. Cleared Jul 2017. https://www.510kdatabase.net/k170775/ 2017-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k170775-mini-stick-envi-non-vascular-fda-510k.jpg K170775 - Mini Stick ENVI Non-Vascular Introducer Kit K170775 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: AngioDynamics, Inc.. Cleared Jul 2017. https://www.510kdatabase.net/k170852/ 2017-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k170852-pod-packing-coil-fda-510k.jpg K170852 - POD Packing Coil K170852 is a FDA 510(k) cleared neurology medical device. Manufacturer: Penumbra, Inc.. Cleared Jul 2017. https://www.510kdatabase.net/k171807/ 2017-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k171807-es2-neuromonitoring-accessory-fda-510k.jpg K171807 - ES2 Neuromonitoring Accessory Instruments K171807 is a FDA 510(k) cleared neurology medical device. Manufacturer: Stryker Corporation. Cleared Jul 2017. https://www.510kdatabase.net/k171824/ 2017-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k171824-acclarix-ax8-diagnostic-ultrasound-fda-510k.jpg K171824 - Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound System K171824 is a FDA 510(k) cleared radiology medical device. Manufacturer: Edan Instruments, Inc.. Cleared Jul 2017. https://www.510kdatabase.net/k163318/ 2017-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k163318-soules-intrauterine-insemination-fda-510k.jpg K163318 - Soules Intrauterine Insemination Catheter K163318 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Cook Incorporated. Cleared Jul 2017. https://www.510kdatabase.net/k171128/ 2017-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k171128-signa-premier-fda-510k.jpg K171128 - SIGNA Premier K171128 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems, LLC. Cleared Jul 2017. https://www.510kdatabase.net/k171413/ 2017-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k171413-haven-laminoplasty-system-canopy-fda-510k.jpg K171413 - HAVEN™ Laminoplasty System, CANOPY® Laminoplasty Fixation System K171413 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Jul 2017. https://www.510kdatabase.net/k171747/ 2017-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k171747-micrusframe-10-stretch-resistant-fda-510k.jpg K171747 - MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and GALAXY G3 XSFT Stretch Resistant Microcoil Delivery System K171747 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Jul 2017. https://www.510kdatabase.net/k162815/ 2017-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k162815-sterilcontainer-s-system-fda-510k.jpg K162815 - SterilContainer S System K162815 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Aesculap, Inc.. Cleared Jul 2017. https://www.510kdatabase.net/k170507/ 2017-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k170507-invacare-tdx-sp2-power-wheelchair-fda-510k.jpg K170507 - Invacare® TDX® SP2 Power Wheelchair K170507 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Invacare Corporation. Cleared Jul 2017. https://www.510kdatabase.net/k171733/ 2017-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k171733-truebeam-truebeam-stx-edge-fda-510k.jpg K171733 - TrueBeam, TrueBeam STx, Edge K171733 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Jul 2017. https://www.510kdatabase.net/k163353/ 2017-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k163353-needles-eye-snare-retrieval-set-54cm-fda-510k.jpg K163353 - Needle's Eye Snare Retrieval Set - 54cm K163353 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Jul 2017. https://www.510kdatabase.net/k163406/ 2017-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k163406-mission-cholesterol-monitoring-system-fda-510k.jpg K163406 - Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring System K163406 is a FDA 510(k) cleared chemistry medical device. Manufacturer: ACON Laboratories, Inc.. Cleared Jul 2017. https://www.510kdatabase.net/k171908/ 2017-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k171908-3m-tegaderm-chg-chlorhexidine-fda-510k.jpg K171908 - 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing K171908 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3M Company. Cleared Jul 2017. https://www.510kdatabase.net/k171034/ 2017-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k171034-m9-diagnostic-ultrasound-system-m9t-fda-510k.jpg K171034 - M9 Diagnostic Ultrasound System, M9T Diagnostic Ultrasound System, M9CV Diagnostic Ultrasound System, M8 Elite Diagnostic Ultrasound System K171034 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Jul 2017. https://www.510kdatabase.net/k162992/ 2017-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k162992-karl-storz-uromat-easi-fda-510k.jpg K162992 - Karl Storz UROMAT E.A.S.I. K162992 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jul 2017. https://www.510kdatabase.net/k163584/ 2017-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k163584-m3290b-philips-intellivue-information-fda-510k.jpg K163584 - M3290B Philips IntelliVue Information Center iX K163584 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Philips Medical Systems. Cleared Jul 2017. https://www.510kdatabase.net/k171448/ 2017-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k171448-hammertoe-correction-system-fda-510k.jpg K171448 - Hammertoe Correction System K171448 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Jul 2017. https://www.510kdatabase.net/k171454/ 2017-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k171454-interject-injection-therapy-needle-fda-510k.jpg K171454 - Interject Injection Therapy Needle Catheter K171454 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Jul 2017. https://www.510kdatabase.net/k170587/ 2017-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k170587-on-call-ketone-reagent-strips-for-fda-510k.jpg K170587 - On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for Urinalysis K170587 is a FDA 510(k) cleared chemistry medical device. Manufacturer: ACON Laboratories, Inc.. Cleared Jul 2017. https://www.510kdatabase.net/k170815/ 2017-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k170815-psa-cable-fda-510k.jpg K170815 - PSA Cable K170815 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Jul 2017. https://www.510kdatabase.net/k171031/ 2017-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k171031-crescent-spinal-system-fda-510k.jpg K171031 - CRESCENT™ Spinal System K171031 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Jul 2017. https://www.510kdatabase.net/k170969/ 2017-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k170969-eclipse-treatment-planning-system-fda-510k.jpg K170969 - Eclipse Treatment Planning System K170969 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Jul 2017. https://www.510kdatabase.net/k170974/ 2017-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k170974-bd-facslyric-flow-cytometer-3-1-4-2-4-fda-510k.jpg K170974 - BD FACSLyric Flow Cytometer (3-1, 4-2, 4-2-2 and 4-3-3 optical configurations), BD FACSuite Clinical Software, BD Multitest 6-Color Assays, BD Multitest 4-Color Assays, BD Multitest 6-Color TBNK K170974 is a FDA 510(k) cleared immunology medical device. Manufacturer: Becton, Dickinson and Company. Cleared Jul 2017. https://www.510kdatabase.net/k171653/ 2017-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k171653-yoga-microcatheter-0032-150cm-back-up-fda-510k.jpg K171653 - YOGA Microcatheter, 0.032, 150cm, Back Up and Extra Back Up K171653 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Jul 2017. https://www.510kdatabase.net/k171613/ 2017-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k171613-asahi-neurovasulature-guide-wire-asahi-fda-510k.jpg K171613 - ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip K171613 is a FDA 510(k) cleared neurology medical device. Manufacturer: Asahi Intecc Co., Ltd.. Cleared Jul 2017. https://www.510kdatabase.net/k170177/ 2017-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k170177-aquilion-one-tsx-305a3-v83-with-first-21-fda-510k.jpg K170177 - Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1 K170177 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshibamedical Systems Corporation. Cleared Jun 2017. https://www.510kdatabase.net/k170249/ 2017-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k170249-gravity-syndesmosis-lp-fda-510k.jpg K170249 - GRAVITY™ Syndesmosis LP K170249 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jun 2017. https://www.510kdatabase.net/k171612/ 2017-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k171612-acuity-pro-lead-delivery-system-fda-510k.jpg K171612 - ACUITY Pro Lead Delivery System K171612 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Jun 2017. https://www.510kdatabase.net/k171621/ 2017-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k171621-welch-allyn-connex-vital-signs-monitor-fda-510k.jpg K171621 - Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor K171621 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Welch Allyn, Inc.. Cleared Jun 2017. https://www.510kdatabase.net/k170896/ 2017-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k170896-admira-fusion-x-base-fda-510k.jpg K170896 - Admira Fusion x-base K170896 is a FDA 510(k) cleared dental medical device. Manufacturer: Voco GmbH. Cleared Jun 2017. https://www.510kdatabase.net/k171514/ 2017-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k171514-biomonitor-2-af-biomonitor-2-s-fit-fda-510k.jpg K171514 - BioMonitor 2-AF, BioMonitor 2-S, FIT - Fast Insert Tool 1 + 2, Set K171514 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biotronik, Inc.. Cleared Jun 2017. https://www.510kdatabase.net/k163216/ 2017-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k163216-pinpoint-gt-needles-fda-510k.jpg K163216 - Pinpoint GT Needles K163216 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jun 2017. https://www.510kdatabase.net/k170817/ 2017-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k170817-halcyon-fda-510k.jpg K170817 - Halcyon K170817 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Jun 2017. https://www.510kdatabase.net/k171794/ 2017-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k171794-smith-nephew-25-fluid-management-system-fda-510k.jpg K171794 - Smith & Nephew 25 Fluid Management System K171794 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jun 2017. https://www.510kdatabase.net/k170416/ 2017-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k170416-lzi-methadone-metabolite-enzyme-fda-510k.jpg K170416 - LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) Calibrators K170416 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Lin-Zhi International, Inc.. Cleared Jun 2017. https://www.510kdatabase.net/k170962/ 2017-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k170962-nuvasive-coroent-thoracolumbar-system-fda-510k.jpg K170962 - NuVasive® CoRoent® Thoracolumbar System K170962 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Jun 2017. https://www.510kdatabase.net/k162678/ 2017-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k162678-elecsys-toxo-igm-elecsys-toxo-igm-fda-510k.jpg K162678 - Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl K162678 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Diagnostics. Cleared Jun 2017. https://www.510kdatabase.net/k162993/ 2017-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k162993-gemini-sterilization-wrap-fda-510k.jpg K162993 - Gemini Sterilization Wrap K162993 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Jun 2017. https://www.510kdatabase.net/k163437/ 2017-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k163437-hypodermic-pinpoint-gt-needle-fda-510k.jpg K163437 - hypodermic Pinpoint™ GT Needle K163437 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jun 2017. https://www.510kdatabase.net/k170759/ 2017-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k170759-cre-pulmonary-balloon-dilatation-fda-510k.jpg K170759 - CRE Pulmonary Balloon Dilatation Catheter K170759 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Boston Scientific Corporation. Cleared Jun 2017. https://www.510kdatabase.net/k163399/ 2017-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k163399-tria-firm-ureteral-stent-fda-510k.jpg K163399 - Tria Firm Ureteral Stent K163399 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Jun 2017. https://www.510kdatabase.net/k170933/ 2017-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k170933-merit-hydrophilic-guide-wire-fda-510k.jpg K170933 - Merit Hydrophilic Guide Wire K170933 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jun 2017. https://www.510kdatabase.net/k162737/ 2017-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k162737-vitek-2-ast-gn-ciprofloxacin-006-4gml-fda-510k.jpg K162737 - VITEK 2 AST-GN Ciprofloxacin (<=0.06->=4µg/mL) K162737 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jun 2017. https://www.510kdatabase.net/k162641/ 2017-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k162641-smith-nephew-inc-r3-constrained-liner-fda-510k.jpg K162641 - Smith & Nephew, Inc. R3™ Constrained Liner K162641 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jun 2017. https://www.510kdatabase.net/k171223/ 2017-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k171223-quantum-ttc-biliary-balloon-dilator-fda-510k.jpg K171223 - Quantum TTC Biliary Balloon Dilator K171223 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Wilson-Cook Medical, Inc.. Cleared Jun 2017. https://www.510kdatabase.net/k162673/ 2017-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k162673-aptima-herpes-simplex-viruses-1-2-assay-fda-510k.jpg K162673 - Aptima Herpes Simplex Viruses 1 & 2 Assay K162673 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Hologic, Inc.. Cleared Jun 2017. https://www.510kdatabase.net/k163084/ 2017-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k163084-merit-coronary-control-syringe-fda-510k.jpg K163084 - Merit Coronary Control Syringe K163084 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jun 2017. https://www.510kdatabase.net/k170263/ 2017-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k170263-acunav-diagnostic-ultrasound-catheter-fda-510k.jpg K170263 - AcuNav Diagnostic Ultrasound Catheter 8F,10F K170263 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 2017. https://www.510kdatabase.net/k170992/ 2017-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k170992-acunav-v-10f-ultrasound-catheter-fda-510k.jpg K170992 - AcuNav V 10F Ultrasound Catheter K170992 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 2017. https://www.510kdatabase.net/k160890/ 2017-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k160890-howell-biliary-introducer-needle-fda-510k.jpg K160890 - Howell Biliary Introducer Needle K160890 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Wilson-Cook Medical, Inc.. Cleared Jun 2017. https://www.510kdatabase.net/k161216/ 2017-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k161216-immunalysis-sefria-fentanyl-urine-fda-510k.jpg K161216 - Immunalysis SEFRIA Fentanyl Urine Enzyme Immunoassay, Immunalysis Fentanyl Urine Calibrators K161216 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Immunalysis Corporation. Cleared Jun 2017. https://www.510kdatabase.net/k170396/ 2017-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k170396-magnetom-vida-fda-510k.jpg K170396 - MAGNETOM Vida K170396 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 2017. https://www.510kdatabase.net/k170457/ 2017-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k170457-evos-small-fragment-lower-extremity-fda-510k.jpg K170457 - EVOS Small Fragment Lower Extremity Plates K170457 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jun 2017. https://www.510kdatabase.net/k170713/ 2017-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k170713-da-vinci-xi-surgical-system-fda-510k.jpg K170713 - da Vinci Xi Surgical System K170713 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Jun 2017. https://www.510kdatabase.net/k171111/ 2017-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k171111-sculpsure-fda-510k.jpg K171111 - Sculpsure K171111 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cynosure, Inc.. Cleared Jun 2017. https://www.510kdatabase.net/k171426/ 2017-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k171426-da-vinci-xi-8mm-endoscope-0-degree-da-fda-510k.jpg K171426 - da Vinci Xi 8mm Endoscope, 0 degree, da Vinci Xi 8mm Endoscope, 30 degree K171426 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Jun 2017. https://www.510kdatabase.net/k171468/ 2017-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k171468-fuse-spinal-system-fda-510k.jpg K171468 - FUSE Spinal System K171468 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Jun 2017. https://www.510kdatabase.net/k162685/ 2017-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k162685-2-piece-hammertoe-correction-system-fda-510k.jpg K162685 - 2-Piece Hammertoe Correction System K162685 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Jun 2017. https://www.510kdatabase.net/k170747/ 2017-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k170747-syngo-application-software-fda-510k.jpg K170747 - syngo Application Software K170747 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 2017. https://www.510kdatabase.net/k162996/ 2017-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k162996-invisiknot-ankle-syndesmosis-repair-kit-fda-510k.jpg K162996 - INVISIKNOT Ankle Syndesmosis Repair Kit K162996 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jun 2017. https://www.510kdatabase.net/k170661/ 2017-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k170661-novosyn-quick-absorbable-suture-fda-510k.jpg K170661 - Novosyn Quick Absorbable Suture K170661 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Jun 2017. https://www.510kdatabase.net/k170961/ 2017-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k170961-nuvasive-coroent-small-interlock-ii-fda-510k.jpg K170961 - NuVasive CoRoent Small Interlock II System K170961 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Jun 2017. https://www.510kdatabase.net/k171066/ 2017-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k171066-bizact-tonsillectomy-device-advanced-fda-510k.jpg K171066 - BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider K171066 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien, LLC. Cleared Jun 2017. https://www.510kdatabase.net/k171222/ 2017-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k171222-vitrea-software-toshiba-package-fda-510k.jpg K171222 - Vitrea Software Toshiba Package K171222 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshibamedical Systems Corporation. Cleared Jun 2017. https://www.510kdatabase.net/k162109/ 2017-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k162109-kwart-retro-inject-ureteral-stent-fda-510k.jpg K162109 - Kwart Retro-Inject Ureteral Stent K162109 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Jun 2017. https://www.510kdatabase.net/k170354/ 2017-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k170354-straumann-variobase-abutments-fda-510k.jpg K170354 - Straumann Variobase Abutments K170354 is a FDA 510(k) cleared dental medical device. Manufacturer: Institut Straumann AG. Cleared Jun 2017. https://www.510kdatabase.net/k170356/ 2017-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k170356-straumann-variobase-abutments-fda-510k.jpg K170356 - Straumann Variobase Abutments K170356 is a FDA 510(k) cleared dental medical device. Manufacturer: Institut Straumann AG. Cleared Jun 2017. https://www.510kdatabase.net/k170412/ 2017-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k170412-vantage-titan-15t-mrt-1510-m-power-gx-fda-510k.jpg K170412 - Vantage Titan 1.5T, MRT-1510, M-Power GX K170412 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshibamedical Systems Corporation. Cleared Jun 2017. https://www.510kdatabase.net/k171335/ 2017-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k171335-venture-038-catheter-fda-510k.jpg K171335 - Venture 038 catheter K171335 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vascular Solutions, Inc.. Cleared Jun 2017. https://www.510kdatabase.net/k170130/ 2017-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k170130-dynamic-coronary-roadmap-fda-510k.jpg K170130 - Dynamic Coronary Roadmap K170130 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Jun 2017. https://www.510kdatabase.net/k170995/ 2017-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k170995-electrocardiograph-fda-510k.jpg K170995 - Electrocardiograph K170995 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edan Instruments, Inc.. Cleared Jun 2017. https://www.510kdatabase.net/k171308/ 2017-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k171308-tubing-pack-fda-510k.jpg K171308 - Tubing Pack K171308 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Jun 2017. https://www.510kdatabase.net/k170158/ 2017-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k170158-powerglide-st-midline-catheter-fda-510k.jpg K170158 - PowerGlide ST Midline Catheter K170158 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jun 2017. https://www.510kdatabase.net/k170490/ 2017-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k170490-celesteion-pca-9000a3-fda-510k.jpg K170490 - Celesteion, PCA-9000A/3 K170490 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshibamedical Systems Corporation. Cleared Jun 2017. https://www.510kdatabase.net/k170904/ 2017-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k170904-biograph-horizon-petct-fda-510k.jpg K170904 - Biograph Horizon PET/CT K170904 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 2017. https://www.510kdatabase.net/k170278/ 2017-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k170278-optifix-at-absorbable-fixation-system-fda-510k.jpg K170278 - OptiFix AT Absorbable Fixation System with Articulating Technology - 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology - 15 Fasteners K170278 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 2017. https://www.510kdatabase.net/k170573/ 2017-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k170573-empowr-cr-knee-tibial-insert-fda-510k.jpg K170573 - Empowr CR Knee Tibial Insert K170573 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Encore Medical, L.P.. Cleared May 2017. https://www.510kdatabase.net/k170670/ 2017-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k170670-etest-ceftolozane-tazobactam-0016-256-fda-510k.jpg K170670 - Etest Ceftolozane/ Tazobactam (0.016-256 ug/ml) K170670 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared May 2017. https://www.510kdatabase.net/k171388/ 2017-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k171388-endowrist-stapler-45-system-and-fda-510k.jpg K171388 - EndoWrist Stapler 45 System and Stapler 45 Reloads K171388 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared May 2017. https://www.510kdatabase.net/k163356/ 2017-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k163356-pulse-spray-infusion-system-unifuse-fda-510k.jpg K163356 - Pulse* Spray Infusion System, Uni*Fuse Infusion System K163356 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: AngioDynamics, Inc.. Cleared May 2017. https://www.510kdatabase.net/k163702/ 2017-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k163702-aplio-i900i800i700-diagnostic-fda-510k.jpg K163702 - Aplio i900/i800/i700 Diagnostic Ultrasound System, V2.1 K163702 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshibamedical Systems Corporation. Cleared May 2017. https://www.510kdatabase.net/k170695/ 2017-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k170695-venacure-evlt-nevertouch-direct-fda-510k.jpg K170695 - VenaCure EVLT NeverTouch Direct Introducer Sheath K170695 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: AngioDynamics, Inc.. Cleared May 2017. https://www.510kdatabase.net/k162448/ 2017-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k162448-white-sizing-catheter-aurous-fda-510k.jpg K162448 - White Sizing Catheter, Aurous Centimeter Sizing Catheter, Cava Vessel Sizing Catheter K162448 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared May 2017. https://www.510kdatabase.net/k162526/ 2017-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k162526-creatine-kinase-mb-fda-510k.jpg K162526 - Creatine Kinase-MB K162526 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared May 2017. https://www.510kdatabase.net/k162603/ 2017-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k162603-masimo-o3-regional-oximeter-system-fda-510k.jpg K162603 - Masimo O3 Regional Oximeter System K162603 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Masimo Corporation. Cleared May 2017. https://www.510kdatabase.net/k171294/ 2017-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k171294-da-vinci-x-surgical-system-fda-510k.jpg K171294 - da Vinci X Surgical System K171294 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared May 2017. https://www.510kdatabase.net/k171296/ 2017-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k171296-suturetape-fda-510k.jpg K171296 - SutureTape K171296 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Arthrex, Inc.. Cleared May 2017. https://www.510kdatabase.net/k170242/ 2017-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k170242-multigen-2-rf-generator-system-fda-510k.jpg K170242 - MultiGen™ 2 RF Generator System K170242 is a FDA 510(k) cleared neurology medical device. Manufacturer: Stryker Corporation. Cleared May 2017. https://www.510kdatabase.net/k171170/ 2017-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k171170-must-pedicle-screw-system-extension-fda-510k.jpg K171170 - M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws K171170 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared May 2017. https://www.510kdatabase.net/k171238/ 2017-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k171238-karl-storz-icg-imaging-system-fda-510k.jpg K171238 - KARL STORZ ICG Imaging System K171238 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared May 2017. https://www.510kdatabase.net/k163197/ 2017-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k163197-cook-holmium-laser-fiber-fda-510k.jpg K163197 - Cook Holmium Laser Fiber K163197 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cook Incorporated. Cleared May 2017. https://www.510kdatabase.net/k163618/ 2017-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k163618-indigo-aspiration-system-fda-510k.jpg K163618 - INDIGO Aspiration System K163618 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Penumbra, Inc.. Cleared May 2017. https://www.510kdatabase.net/k170603/ 2017-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k170603-tao-brush-iumc-endometrial-sampler-fda-510k.jpg K170603 - Tao Brush I.U.M.C. Endometrial Sampler K170603 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Cook Incorporated. Cleared May 2017. https://www.510kdatabase.net/k162598/ 2017-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k162598-hapi-seal-fda-510k.jpg K162598 - HAPI Seal K162598 is a FDA 510(k) cleared dental medical device. Manufacturer: Bisco, Inc.. Cleared May 2017. https://www.510kdatabase.net/k163430/ 2017-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k163430-prontosan-wound-gel-fda-510k.jpg K163430 - Prontosan Wound Gel K163430 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: B.Braun Medical, Inc.. Cleared May 2017. https://www.510kdatabase.net/k163658/ 2017-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k163658-advia-centaur-intact-parathyroid-fda-510k.jpg K163658 - ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay K163658 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared May 2017. https://www.510kdatabase.net/k170282/ 2017-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k170282-smith-nephew-visionaire-adaptive-guides-fda-510k.jpg K170282 - Smith & Nephew VISIONAIRE Adaptive Guides K170282 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared May 2017. https://www.510kdatabase.net/k170586/ 2017-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k170586-strep-b-carrot-broth-one-step-fda-510k.jpg K170586 - Strep B Carrot Broth One-Step K170586 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Hardy Diagnostics. Cleared May 2017. https://www.510kdatabase.net/k171348/ 2017-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k171348-pinpoint-gt-needle-guide-kits-fda-510k.jpg K171348 - Pinpoint GT Needle Guide Kits K171348 is a FDA 510(k) cleared radiology medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 2017. https://www.510kdatabase.net/k162212/ 2017-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k162212-divergence-l-anterioroblique-lumbar-fda-510k.jpg K162212 - DIVERGENCE-L ANTERIOR/OBLIQUE LUMBAR FUSION SYSTEM K162212 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared May 2017. https://www.510kdatabase.net/k171152/ 2017-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k171152-stryker-universal-neuro-iii-system-axs-fda-510k.jpg K171152 - Stryker Universal Neuro III System AXS Screw K171152 is a FDA 510(k) cleared neurology medical device. Manufacturer: Stryker. Cleared May 2017. https://www.510kdatabase.net/k160509/ 2017-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k160509-tiger-2-self-advancing-nasal-jejunal-fda-510k.jpg K160509 - Tiger 2 Self-Advancing Nasal Jejunal Feeding Tube K160509 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared May 2017. https://www.510kdatabase.net/k160567/ 2017-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k160567-barone-jejunostomy-catheter-set-fda-510k.jpg K160567 - Barone Jejunostomy Catheter Set K160567 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared May 2017. https://www.510kdatabase.net/k170639/ 2017-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k170639-healix-advance-anchor-with-permatape-fda-510k.jpg K170639 - HEALIX ADVANCE Anchor with PERMATAPE Suture K170639 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International SARL. Cleared May 2017. https://www.510kdatabase.net/k170804/ 2017-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k170804-the-solstice-oct-system-fda-510k.jpg K170804 - The Solstice OCT System K170804 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared May 2017. https://www.510kdatabase.net/k163181/ 2017-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k163181-translace-spinal-tethering-system-fda-510k.jpg K163181 - TRANSLACE™ Spinal Tethering System K163181 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared May 2017. https://www.510kdatabase.net/k163701/ 2017-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k163701-direxion-and-direxion-hi-flo-fda-510k.jpg K163701 - Direxion and Direxion HI-FLO Torqueable Microcatheters K163701 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared May 2017. https://www.510kdatabase.net/k170462/ 2017-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k170462-karl-storz-shuntscope-fda-510k.jpg K170462 - KARL STORZ ShuntScope K170462 is a FDA 510(k) cleared neurology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared May 2017. https://www.510kdatabase.net/k170481/ 2017-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k170481-strep-b-carrot-broth-kit-fda-510k.jpg K170481 - Strep B Carrot Broth Kit K170481 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Hardy Diagnostics. Cleared May 2017. https://www.510kdatabase.net/k170496/ 2017-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k170496-xia-3-spinal-system-stryker-spine-fda-510k.jpg K170496 - Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory K170496 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Corporation. Cleared May 2017. https://www.510kdatabase.net/k171020/ 2017-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k171020-arthrex-knotless-suturetak-anchor-fda-510k.jpg K171020 - Arthrex Knotless SutureTak Anchor K171020 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared May 2017. https://www.510kdatabase.net/k153410/ 2017-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k153410-3m-tegaderm-chg-chlorhexidine-fda-510k.jpg K153410 - 3M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing K153410 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3M Company. Cleared May 2017. https://www.510kdatabase.net/k162333/ 2017-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k162333-wondfo-one-step-fecal-occult-blood-fob-fda-510k.jpg K162333 - Wondfo One Step Fecal Occult Blood (FOB) Test K162333 is a FDA 510(k) cleared hematology medical device. Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.. Cleared May 2017. https://www.510kdatabase.net/k170199/ 2017-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k170199-unity-network-id-fda-510k.jpg K170199 - Unity Network ID K170199 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Healthcare. Cleared May 2017. https://www.510kdatabase.net/k163250/ 2017-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k163250-longitudinal-brain-imaging-lobi-fda-510k.jpg K163250 - Longitudinal Brain Imaging (LoBI) application K163250 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared May 2017. https://www.510kdatabase.net/k163276/ 2017-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k163276-fully-automatic-electronic-blood-fda-510k.jpg K163276 - Fully Automatic Electronic Blood Pressure Monitor K163276 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Andon Health Co, Ltd.. Cleared May 2017. https://www.510kdatabase.net/k163576/ 2017-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k163576-gore-synecor-preperitoneal-biomaterial-fda-510k.jpg K163576 - GORE SYNECOR Preperitoneal Biomaterial K163576 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared May 2017. https://www.510kdatabase.net/k170135/ 2017-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k170135-trefoil-system-fda-510k.jpg K170135 - TREFOIL System K170135 is a FDA 510(k) cleared dental medical device. Manufacturer: Nobel Biocare AB. Cleared May 2017. https://www.510kdatabase.net/k170382/ 2017-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k170382-arthrex-compression-screws-fda-510k.jpg K170382 - Arthrex Compression Screws K170382 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared May 2017. https://www.510kdatabase.net/k170648/ 2017-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k170648-anthem-cr-total-knee-system-fda-510k.jpg K170648 - ANTHEM CR Total Knee System K170648 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared May 2017. https://www.510kdatabase.net/k170679/ 2017-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k170679-cd-horizon-spinal-system-medtronic-fda-510k.jpg K170679 - CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems K170679 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared May 2017. https://www.510kdatabase.net/k171097/ 2017-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k171097-mojave-expandable-interbody-system-fda-510k.jpg K171097 - MOJAVE Expandable Interbody System K171097 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: K2m, Inc.. Cleared May 2017. https://www.510kdatabase.net/k170740/ 2017-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k170740-gore-viabil-short-wire-biliary-fda-510k.jpg K170740 - GORE VIABIL Short Wire Biliary Endoprosthesis K170740 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared May 2017. https://www.510kdatabase.net/k162449/ 2017-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k162449-solero-mta-system-solero-microwave-fda-510k.jpg K162449 - Solero MTA System, Solero Microwave Tissue Ablation Applicator (14cm), Solero Microwave Tissue Ablation Applicator (19cm),Solero Microwave Tissue Ablation Applicator (29cm) K162449 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: AngioDynamics, Inc.. Cleared May 2017. https://www.510kdatabase.net/k163315/ 2017-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k163315-internal-distraction-sterile-fda-510k.jpg K163315 - Internal Distraction - Sterile K163315 is a FDA 510(k) cleared neurology medical device. Manufacturer: KLS-Martin L.P.. Cleared May 2017. https://www.510kdatabase.net/k170543/ 2017-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k170543-viper-prime-screws-with-fenestrations-fda-510k.jpg K170543 - VIPER PRIME™ Screws with Fenestrations K170543 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medos International SARL. Cleared May 2017. https://www.510kdatabase.net/k171141/ 2017-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k171141-arthrex-swivelock-anchors-fda-510k.jpg K171141 - Arthrex SwiveLock Anchors K171141 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared May 2017. https://www.510kdatabase.net/k163530/ 2017-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k163530-prismax-control-unit-fda-510k.jpg K163530 - PrisMax Control Unit K163530 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared May 2017. https://www.510kdatabase.net/k170977/ 2017-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k170977-sureshot-distal-targeting-system-v40-fda-510k.jpg K170977 - SURESHOT Distal Targeting System V4.0 Trauma Interface K170977 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared May 2017. https://www.510kdatabase.net/k170308/ 2017-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k170308-bd-max-extended-enteric-bacterial-fda-510k.jpg K170308 - BD MAX Extended Enteric Bacterial Panel, BD MAX System K170308 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson and Company. Cleared May 2017. https://www.510kdatabase.net/k162266/ 2017-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k162266-the-cranial-fusion-system-fda-510k.jpg K162266 - The Cranial Fusion System K162266 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared May 2017. https://www.510kdatabase.net/k162303/ 2017-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k162303-redapt-sleeved-monolithic-revision-stems-fda-510k.jpg K162303 - REDAPT Sleeved Monolithic Revision Stems K162303 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared May 2017. https://www.510kdatabase.net/k162647/ 2017-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k162647-nuvasive-nuvaline-mobile-app-fda-510k.jpg K162647 - NuVasive NuvaLine Mobile App K162647 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nu Vasive, Incorporated. Cleared May 2017. https://www.510kdatabase.net/k162825/ 2017-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k162825-captivate-compression-screws-fda-510k.jpg K162825 - CAPTIVATE™ Compression Screws K162825 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared May 2017. https://www.510kdatabase.net/k163707/ 2017-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k163707-nuvasive-coroent-ti-c-system-fda-510k.jpg K163707 - NuVasive CoRoent Ti-C System K163707 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared May 2017. https://www.510kdatabase.net/k161596/ 2017-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k161596-soft-vu-mariner-accu-vu-and-angiooptic-fda-510k.jpg K161596 - Soft-Vu, Mariner, Accu-Vu and AngioOptic Catheters K161596 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: AngioDynamics, Inc.. Cleared Apr 2017. https://www.510kdatabase.net/k162200/ 2017-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k162200-randox-rx-daytona-plus-magnesium-mg-fda-510k.jpg K162200 - Randox RX Daytona Plus Magnesium (MG) K162200 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Randox Laboratories, Ltd.. Cleared Apr 2017. https://www.510kdatabase.net/k162945/ 2017-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k162945-verify-assert-steam-process-challenge-fda-510k.jpg K162945 - VERIFY ASSERT STEAM Process Challenge Device K162945 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Apr 2017. https://www.510kdatabase.net/k170070/ 2017-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k170070-verify-assert-steam-process-challenge-fda-510k.jpg K170070 - VERIFY ASSERT STEAM Process Challenge Device for Gravity Cycles K170070 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Apr 2017. https://www.510kdatabase.net/k170280/ 2017-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k170280-smith-nephew-sureshot-distal-targeting-fda-510k.jpg K170280 - Smith & Nephew SURESHOT Distal Targeting System V4.0 K170280 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Apr 2017. https://www.510kdatabase.net/k170616/ 2017-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k170616-van-andel-dilatation-catheter-fda-510k.jpg K170616 - van Andel Dilatation Catheter K170616 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Apr 2017. https://www.510kdatabase.net/k170952/ 2017-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k170952-syngoct-viewgo-fda-510k.jpg K170952 - syngo.CT View&GO K170952 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 2017. https://www.510kdatabase.net/k171045/ 2017-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k171045-exactech-truliant-line-extensions-fda-510k.jpg K171045 - Exactech® Truliant™ Line Extensions K171045 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Apr 2017. https://www.510kdatabase.net/k162142/ 2017-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k162142-accessory-irrigation-adapter-fda-510k.jpg K162142 - Accessory Irrigation Adapter K162142 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Wilson-Cook Medical, Inc.. Cleared Apr 2017. https://www.510kdatabase.net/k162732/ 2017-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k162732-exactech-alteon-ha-femoral-stem-fda-510k.jpg K162732 - Exactech® Alteon® HA Femoral Stem K162732 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Apr 2017. https://www.510kdatabase.net/k170592/ 2017-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k170592-nuvasive-base-interfixated-titanium-fda-510k.jpg K170592 - NuVasive BASE Interfixated Titanium System K170592 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Apr 2017. https://www.510kdatabase.net/k170889/ 2017-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k170889-hv-screw-system-fda-510k.jpg K170889 - HV Screw System K170889 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Apr 2017. https://www.510kdatabase.net/k170938/ 2017-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k170938-calset-igf-1-fda-510k.jpg K170938 - CalSet IGF-1 K170938 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Apr 2017. https://www.510kdatabase.net/k162104/ 2017-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k162104-c-flex-ureteral-stent-set-fda-510k.jpg K162104 - C-Flex Ureteral Stent Set K162104 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Apr 2017. https://www.510kdatabase.net/k162441/ 2017-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k162441-powerpicc-provena-catheters-with-solo-fda-510k.jpg K162441 - PowerPICC Provena Catheters with SOLO Valve Technology K162441 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 2017. https://www.510kdatabase.net/k163650/ 2017-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k163650-ortholoc-3di-ankle-fusion-plating-fda-510k.jpg K163650 - ORTHOLOC® 3Di Ankle Fusion Plating System Line Extension K163650 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Apr 2017. https://www.510kdatabase.net/k170887/ 2017-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k170887-evos-small-fragment-plating-system-fda-510k.jpg K170887 - EVOS Small Fragment Plating System K170887 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Apr 2017. https://www.510kdatabase.net/k163537/ 2017-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k163537-arcpoint-pulmonary-needle-18-ga-fda-510k.jpg K163537 - Arcpoint pulmonary needle - 18 ga, Arcpoint pulmonary needle - 21 ga K163537 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Covidien, LLC. Cleared Apr 2017. https://www.510kdatabase.net/k170865/ 2017-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k170865-endowrist-vessel-sealer-8-mm-harmonic-fda-510k.jpg K170865 - EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, da Vinci Single-Site Instruments and Accessories K170865 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Apr 2017. https://www.510kdatabase.net/k170869/ 2017-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k170869-ligasure-maryland-jaw-sealerdivider-fda-510k.jpg K170869 - LigaSure Maryland Jaw Sealer/Divider One-step Sealing, Nano-coated K170869 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien. Cleared Apr 2017. https://www.510kdatabase.net/k162607/ 2017-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k162607-benevision-central-monitoring-system-fda-510k.jpg K162607 - BeneVision Central Monitoring System K162607 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Apr 2017. https://www.510kdatabase.net/k162722/ 2017-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k162722-hypersense-fda-510k.jpg K162722 - HyperSense K162722 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems, LLC. Cleared Apr 2017. https://www.510kdatabase.net/k162901/ 2017-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k162901-penumbra-3d-revascularization-device-fda-510k.jpg K162901 - Penumbra 3D Revascularization Device K162901 is a FDA 510(k) cleared neurology medical device. Manufacturer: Penumbra, Inc.. Cleared Apr 2017. https://www.510kdatabase.net/k163690/ 2017-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k163690-dc-70dc-70t-dc-70-prodc-70-expdc-75dc-fda-510k.jpg K163690 - DC-70/DC-70T /DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System K163690 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Apr 2017. https://www.510kdatabase.net/k162621/ 2017-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k162621-invacare-tracer-sx5-manual-wheelchair-fda-510k.jpg K162621 - Invacare Tracer SX5 Manual Wheelchair, Invacare Tracer IV Heavy Duty/Extra Wide Manual Wheelchair K162621 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Invacare Corporation. Cleared Apr 2017. https://www.510kdatabase.net/k163001/ 2017-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k163001-powerflow-apheresis-iv-port-fda-510k.jpg K163001 - PowerFlow Apheresis I.V. Port K163001 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 2017. https://www.510kdatabase.net/k161741/ 2017-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k161741-gmk-uni-fda-510k.jpg K161741 - GMK UNI K161741 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Apr 2017. https://www.510kdatabase.net/k162382/ 2017-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k162382-smart-dongle-blood-glucose-monitoring-fda-510k.jpg K162382 - Smart Dongle Blood Glucose Monitoring System K162382 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Taidoc Technology Corporation. Cleared Apr 2017. https://www.510kdatabase.net/k163171/ 2017-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k163171-ceraclean-fda-510k.jpg K163171 - CeraClean K163171 is a FDA 510(k) cleared dental medical device. Manufacturer: Bisco, Inc.. Cleared Apr 2017. https://www.510kdatabase.net/k163381/ 2017-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k163381-hemosphere-advanced-monitor-hemosphere-fda-510k.jpg K163381 - HemoSphere Advanced Monitor, HemoSphere Swan-Ganz Module, HemoSphere Oximetry Cable K163381 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Apr 2017. https://www.510kdatabase.net/k163581/ 2017-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k163581-navigated-elevate-inserter-navigated-fda-510k.jpg K163581 - Navigated ELEVATE Inserter, Navigated Disc Prep Instruments K163581 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Apr 2017. https://www.510kdatabase.net/k162353/ 2017-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k162353-micatm-screw-system-fda-510k.jpg K162353 - MICATM Screw System K162353 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Apr 2017. https://www.510kdatabase.net/den160056/ 2017-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/den160056-philips-intellisite-pathology-solution-fda-510k.jpg DEN160056 - Philips IntelliSite Pathology Solution DEN160056 is a FDA 510(k) cleared pathology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Apr 2017. https://www.510kdatabase.net/k163698/ 2017-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k163698-optifix-open-absorbable-fixation-fda-510k.jpg K163698 - OptiFix Open Absorbable Fixation System - 20 absorbable fasteners K163698 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 2017. https://www.510kdatabase.net/k170445/ 2017-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k170445-logiq-s8-fda-510k.jpg K170445 - LOGIQ S8 K170445 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Apr 2017. https://www.510kdatabase.net/k162838/ 2017-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k162838-philips-ict-ct-system-fda-510k.jpg K162838 - Philips iCT CT System K162838 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Apr 2017. https://www.510kdatabase.net/k163361/ 2017-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k163361-anthem-fracture-system-fda-510k.jpg K163361 - ANTHEM™ Fracture System K163361 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Apr 2017. https://www.510kdatabase.net/k153763/ 2017-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k153763-howell-biliary-aspiration-needle-fda-510k.jpg K153763 - Howell Biliary Aspiration Needle K153763 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Wilson-Cook Medical, Inc.. Cleared Apr 2017. https://www.510kdatabase.net/k163101/ 2017-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k163101-cedia-buprenorphine-ii-assay-fda-510k.jpg K163101 - CEDIA Buprenorphine II Assay K163101 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Microgenics Corporation. Cleared Apr 2017. https://www.510kdatabase.net/k163220/ 2017-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k163220-atellica-ch-phencyclidine-pcp-fda-510k.jpg K163220 - Atellica CH Phencyclidine (Pcp) K163220 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Apr 2017. https://www.510kdatabase.net/k170700/ 2017-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k170700-inqwire-diagnostic-guide-wire-fda-510k.jpg K170700 - Inqwire Diagnostic Guide Wire K170700 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Apr 2017. https://www.510kdatabase.net/k161332/ 2017-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k161332-nile-proximal-fixation-spinal-system-fda-510k.jpg K161332 - NILE Proximal Fixation Spinal System K161332 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: K2m, Inc.. Cleared Apr 2017. https://www.510kdatabase.net/k163711/ 2017-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k163711-iqon-spectral-ct-fda-510k.jpg K163711 - IQon Spectral CT K163711 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Apr 2017. https://www.510kdatabase.net/k170668/ 2017-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k170668-heartspan-steerable-sheath-introducer-fda-510k.jpg K170668 - HeartSpan Steerable Sheath Introducer K170668 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Apr 2017. https://www.510kdatabase.net/k163458/ 2017-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k163458-zenysis-short-term-dialysis-catheter-fda-510k.jpg K163458 - Zenysis Short-Term Dialysis Catheter K163458 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 2017. https://www.510kdatabase.net/k170678/ 2017-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k170678-beta-crosslaps-calcheck-5-fda-510k.jpg K170678 - Beta-CrossLaps CalCheck 5 K170678 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Apr 2017. https://www.510kdatabase.net/k163426/ 2017-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k163426-asahi-ptca-peripheral-and-fda-510k.jpg K163426 - ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension K163426 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Asahi Intecc Co., Ltd.. Cleared Apr 2017. https://www.510kdatabase.net/k161635/ 2017-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k161635-amistem-h-proximal-coating-fda-510k.jpg K161635 - AMIStem-H Proximal Coating K161635 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Mar 2017. https://www.510kdatabase.net/k162413/ 2017-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k162413-amsco-v-pro-1-low-temperature-fda-510k.jpg K162413 - AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System K162413 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Mar 2017. https://www.510kdatabase.net/k162559/ 2017-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k162559-move-forward-3d-motion-simulation-fda-510k.jpg K162559 - Move Forward 3D Motion Simulation Service K162559 is a FDA 510(k) cleared radiology medical device. Manufacturer: Biomet, Inc.. Cleared Mar 2017. https://www.510kdatabase.net/k163649/ 2017-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k163649-suresigns-vs3-fda-510k.jpg K163649 - SureSigns VS3 K163649 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Philips Medical Systems. Cleared Mar 2017. https://www.510kdatabase.net/k170098/ 2017-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k170098-iconix-tt-all-suture-anchor-fda-510k.jpg K170098 - ICONIX TT All Suture Anchor K170098 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker. Cleared Mar 2017. https://www.510kdatabase.net/k170622/ 2017-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k170622-bakri-postpartum-balloon-bakri-fda-510k.jpg K170622 - Bakri Postpartum Balloon, Bakri Postpartum Balloon with Rapid Instillation Component K170622 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Cook Incorporated. Cleared Mar 2017. https://www.510kdatabase.net/k170628/ 2017-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k170628-biomonitor-2-af-biomonitor-2-s-fda-510k.jpg K170628 - BioMonitor 2-AF, BioMonitor 2-S K170628 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biotronik, Inc.. Cleared Mar 2017. https://www.510kdatabase.net/k170271/ 2017-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k170271-nuvasiver-monolith-corpectomy-system-fda-510k.jpg K170271 - NuVasive(r) Monolith Corpectomy System K170271 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Mar 2017. https://www.510kdatabase.net/k170743/ 2017-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k170743-angiodynamics-total-abscession-biliary-fda-510k.jpg K170743 - AngioDynamics Total Abscession Biliary Drainage Catheter K170743 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: AngioDynamics, Inc.. Cleared Mar 2017. https://www.510kdatabase.net/k162999/ 2017-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k162999-v-grip-detachment-controller-for-use-fda-510k.jpg K162999 - V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System K162999 is a FDA 510(k) cleared neurology medical device. Manufacturer: MicroVention, Inc.. Cleared Mar 2017. https://www.510kdatabase.net/k163052/ 2017-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k163052-brevera-biopsy-system-with-corlumina-fda-510k.jpg K163052 - Brevera Biopsy System with Corlumina Imaging Technology K163052 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hologic, Inc.. Cleared Mar 2017. https://www.510kdatabase.net/k161816/ 2017-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k161816-bactalert-virtuo-microbial-detection-fda-510k.jpg K161816 - BacT/ALERT VIRTUO Microbial Detection System, BacT/ALERT VIRTUO, VIRTUO K161816 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Mar 2017. https://www.510kdatabase.net/k163248/ 2017-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k163248-expect-pulmonary-endobronchial-fda-510k.jpg K163248 - Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle K163248 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Boston Scientific Corporation. Cleared Mar 2017. https://www.510kdatabase.net/k162615/ 2017-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k162615-mould-applicator-set-fda-510k.jpg K162615 - Mould Applicator Set K162615 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Mar 2017. https://www.510kdatabase.net/k162701/ 2017-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k162701-verify-assert-self-contained-fda-510k.jpg K162701 - VERIFY Assert Self-Contained Biological Indicator K162701 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Mar 2017. https://www.510kdatabase.net/k163297/ 2017-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k163297-scango-fda-510k.jpg K163297 - Scan&GO K163297 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2017. https://www.510kdatabase.net/k163491/ 2017-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k163491-nuvasive-coroent-small-interbody-system-fda-510k.jpg K163491 - NuVasive CoRoent Small Interbody System K163491 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Mar 2017. https://www.510kdatabase.net/k163587/ 2017-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k163587-verify-incubator-for-assert-self-fda-510k.jpg K163587 - VERIFY Incubator for Assert Self Contained Biological Indicators K163587 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Mar 2017. https://www.510kdatabase.net/k170204/ 2017-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k170204-ffr-link-ffr-signal-processing-module-fda-510k.jpg K170204 - FFR Link, FFR Signal Processing Module K170204 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Mar 2017. https://www.510kdatabase.net/k163314/ 2017-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k163314-guidezilla-ii-guide-extension-catheter-fda-510k.jpg K163314 - Guidezilla II Guide Extension Catheter K163314 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Mar 2017. https://www.510kdatabase.net/k170277/ 2017-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k170277-dc-8dc-8-prodc-8-cvdc-8-expdc-8s-fda-510k.jpg K170277 - DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S Diagnostic Ultrasound System K170277 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Mar 2017. https://www.510kdatabase.net/k170636/ 2017-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k170636-fathom-16-steerable-guidewires-fda-510k.jpg K170636 - Fathom-16 Steerable Guidewires K170636 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Mar 2017. https://www.510kdatabase.net/k162740/ 2017-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k162740-microscan-dried-gram-negative-miccombo-fda-510k.jpg K162740 - MicroScan Dried Gram-Negative MIC/Combo Panels with Imipenem (0.25 - 8 ug/mL) K162740 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Mar 2017. https://www.510kdatabase.net/k162758/ 2017-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k162758-verify-sixcess-steam-indicators-verify-fda-510k.jpg K162758 - VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test Pack, VERIFY SixCess Challenge Pack, VERIFY SixCess FP Challenge Pack K162758 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Mar 2017. https://www.510kdatabase.net/k163296/ 2017-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k163296-somatom-goup-somatom-gonow-fda-510k.jpg K163296 - SOMATOM go.Up, SOMATOM go.Now K163296 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2017. https://www.510kdatabase.net/k163331/ 2017-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k163331-discovery-mr750-30t-fda-510k.jpg K163331 - Discovery MR750 3.0T K163331 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems, LLC. Cleared Mar 2017. https://www.510kdatabase.net/k163569/ 2017-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k163569-elecsys-cmv-igm-fda-510k.jpg K163569 - Elecsys CMV IgM K163569 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Diagnostics. Cleared Mar 2017. https://www.510kdatabase.net/k170501/ 2017-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k170501-crossft-knotless-biocomposite-suture-fda-510k.jpg K170501 - CrossFT Knotless Biocomposite Suture Anchor with Disposable Driver K170501 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Conmed Corporation. Cleared Mar 2017. https://www.510kdatabase.net/k170583/ 2017-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k170583-intersept-filtered-cardiotomy-fda-510k.jpg K170583 - Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface K170583 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Mar 2017. https://www.510kdatabase.net/k161416/ 2017-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k161416-multi-unit-abutment-plus-fda-510k.jpg K161416 - Multi-unit Abutment Plus K161416 is a FDA 510(k) cleared dental medical device. Manufacturer: Nobel Biocare AB. Cleared Mar 2017. https://www.510kdatabase.net/k162298/ 2017-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k162298-loci-total-vitamin-d-total-assay-loci-fda-510k.jpg K162298 - LOCI Total Vitamin D Total Assay, LOCI VITD CAL K162298 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics. Cleared Mar 2017. https://www.510kdatabase.net/k162313/ 2017-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k162313-nuvasive-next-generation-nvm5-system-fda-510k.jpg K162313 - NuVasive Next Generation NVM5 System K162313 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Mar 2017. https://www.510kdatabase.net/k162880/ 2017-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k162880-tipcam-1s-3d-system-fda-510k.jpg K162880 - TIPCAM 1S 3D System K162880 is a FDA 510(k) cleared neurology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Mar 2017. https://www.510kdatabase.net/k163230/ 2017-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k163230-nuvasive-modulus-xlif-interbody-system-fda-510k.jpg K163230 - NuVasive Modulus XLIF Interbody System K163230 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Mar 2017. https://www.510kdatabase.net/k170455/ 2017-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k170455-mectalif-anterior-stand-alone-fda-510k.jpg K170455 - MectaLIF Anterior Stand Alone K170455 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Mar 2017. https://www.510kdatabase.net/k161598/ 2017-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k161598-nobelzygoma-0-fda-510k.jpg K161598 - NobelZygoma 0° K161598 is a FDA 510(k) cleared dental medical device. Manufacturer: Nobel Biocare AB. Cleared Mar 2017. https://www.510kdatabase.net/k170127/ 2017-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k170127-hardydisk-ceftolozanetazobactam-3010-fda-510k.jpg K170127 - HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40 K170127 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Hardy Diagnostics. Cleared Mar 2017. https://www.510kdatabase.net/k163039/ 2017-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k163039-ortholoc-3di-small-bones-plating-fda-510k.jpg K163039 - ORTHOLOC® 3Di Small Bones Plating K163039 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Mar 2017. https://www.510kdatabase.net/k163563/ 2017-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k163563-vitek-2-ast-gn-gentamicin-1-16-gml-fda-510k.jpg K163563 - VITEK 2 AST-GN Gentamicin (<=1 – >=16 µg/mL) K163563 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Mar 2017. https://www.510kdatabase.net/k163152/ 2017-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k163152-prolene-soft-polypropylene-mesh-fda-510k.jpg K163152 - PROLENE Soft Polypropylene Mesh K163152 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Mar 2017. https://www.510kdatabase.net/k160815/ 2017-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k160815-interstitial-needles-fda-510k.jpg K160815 - Interstitial Needles K160815 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Mar 2017. https://www.510kdatabase.net/k162793/ 2017-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k162793-rhythmia-hdx-mapping-system-fda-510k.jpg K162793 - RHYTHMIA HDx Mapping System K162793 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Mar 2017. https://www.510kdatabase.net/k163495/ 2017-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k163495-advance-capsule-endoscope-delivery-fda-510k.jpg K163495 - AdvanCE capsule endoscope delivery device K163495 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: United States Endoscopy Group, Inc.. Cleared Mar 2017. https://www.510kdatabase.net/k170336/ 2017-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k170336-bd-nexiva-closed-iv-catheter-system-fda-510k.jpg K170336 - BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless Connector K170336 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson and Company. Cleared Mar 2017. https://www.510kdatabase.net/k170508/ 2017-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k170508-endowrist-stapler-45-instrument-fda-510k.jpg K170508 - EndoWrist Stapler 45 Instrument, EndoWrist Stapler 45 Reloads, EndoWrist Stapler 30 Instrument, EndoWrist Stapler 30 Reloads K170508 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Mar 2017. https://www.510kdatabase.net/k161954/ 2017-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k161954-atellica-solution-atellica-a-lyte-fda-510k.jpg K161954 - Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc) K161954 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics. Cleared Mar 2017. https://www.510kdatabase.net/k170065/ 2017-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k170065-advia-chemistry-total-bilirubin2-tbil2-fda-510k.jpg K170065 - ADVIA® Chemistry Total Bilirubin_2 (TBIL_2) K170065 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Mar 2017. https://www.510kdatabase.net/k170124/ 2017-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k170124-level-one-hand-plating-system-fda-510k.jpg K170124 - Level One Hand Plating System K170124 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: KLS-Martin L.P.. Cleared Mar 2017. https://www.510kdatabase.net/k170126/ 2017-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k170126-nuvasive-reline-45-50-system-fda-510k.jpg K170126 - NuVasive® Reline® 4.5-5.0 System K170126 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Nu Vasive, Incorporated. Cleared Mar 2017. https://www.510kdatabase.net/k163307/ 2017-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k163307-expro-elite-snare-sympro-elite-snare-fda-510k.jpg K163307 - Expro Elite Snare, Sympro Elite Snare K163307 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vascular Solutions, Inc.. Cleared Mar 2017. https://www.510kdatabase.net/k163654/ 2017-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k163654-versaone-fascial-closure-system-bladed-fda-510k.jpg K163654 - VersaOne fascial closure system bladed trocar, VersaOne fascial closure system bladeless trocar, VersaOne fascial closure system optical trocar K163654 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien, LLC. Cleared Mar 2017. https://www.510kdatabase.net/k162311/ 2017-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k162311-straumann-prefgel-fda-510k.jpg K162311 - Straumann PrefGel K162311 is a FDA 510(k) cleared dental medical device. Manufacturer: Institut Straumann AG. Cleared Mar 2017. https://www.510kdatabase.net/k162035/ 2017-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k162035-gmk-sphere-fda-510k.jpg K162035 - GMK Sphere K162035 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Mar 2017. https://www.510kdatabase.net/k162325/ 2017-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k162325-exactech-equinoxe-reverse-shoulder-fda-510k.jpg K162325 - Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder Compression Screws, Exactech Equinoxe Reverse Shoulder Glenosphere Locking Screw K162325 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Mar 2017. https://www.510kdatabase.net/den160019/ 2017-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/den160019-cintec-histology-50-tests-cintec-fda-510k.jpg DEN160019 - CINtec Histology (50 tests), CINtec Histology (250 tests) DEN160019 is a FDA 510(k) cleared pathology medical device. Manufacturer: Ventana Medical Systems, Inc.. Cleared Mar 2017. https://www.510kdatabase.net/k162524/ 2017-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k162524-azur-cx-detachable-18-peripheral-coil-fda-510k.jpg K162524 - AZUR CX Detachable 18 Peripheral Coil System K162524 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: MicroVention, Inc.. Cleared Mar 2017. https://www.510kdatabase.net/k163528/ 2017-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k163528-hitachi-supria-whole-body-x-ray-ct-fda-510k.jpg K163528 - HITACHI Supria Whole-body X-ray CT System Phase 3 K163528 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hitachi Medical Systems America, Inc.. Cleared Mar 2017. https://www.510kdatabase.net/k163575/ 2017-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k163575-inqwire-diagnostic-guide-wire-fda-510k.jpg K163575 - Inqwire Diagnostic Guide Wire K163575 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Mar 2017. https://www.510kdatabase.net/k170314/ 2017-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k170314-acl-acustar-fda-510k.jpg K170314 - ACL AcuStar K170314 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Mar 2017. https://www.510kdatabase.net/k161554/ 2017-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k161554-endoflator-40-endoflator-50-fda-510k.jpg K161554 - ENDOFLATOR 40, ENDOFLATOR 50 K161554 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Mar 2017. https://www.510kdatabase.net/k162410/ 2017-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k162410-tipcam-1s-3d-system-fda-510k.jpg K162410 - TIPCAM 1S 3D System K162410 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Mar 2017. https://www.510kdatabase.net/k163497/ 2017-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k163497-exprt-revision-hip-system-exprt-hip-fda-510k.jpg K163497 - EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal Body Implant, EXPRT™ Hip Lateral Offset Proximal Body Implant, EXPRT™ Hip Capture Bolt K163497 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Encore Medical, L.P.. Cleared Mar 2017. https://www.510kdatabase.net/k170348/ 2017-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k170348-signia-four-bay-smart-charger-to-be-fda-510k.jpg K170348 - Signia Four-Bay Smart Charger (to be used with Signia Stapler) K170348 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien. Cleared Mar 2017. https://www.510kdatabase.net/k170420/ 2017-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k170420-nce-glass-ceramic-blocks-for-amann-fda-510k.jpg K170420 - n!ce Glass Ceramic Blocks for Amann Girrbach K170420 is a FDA 510(k) cleared dental medical device. Manufacturer: Institut Straumann AG. Cleared Mar 2017. https://www.510kdatabase.net/k163284/ 2017-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k163284-syngo-ct-neuro-perfusion-fda-510k.jpg K163284 - syngo. CT Neuro Perfusion K163284 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2017. https://www.510kdatabase.net/k161655/ 2017-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k161655-on1-concept-fda-510k.jpg K161655 - On1 Concept K161655 is a FDA 510(k) cleared dental medical device. Manufacturer: Nobel Biocare AB. Cleared Feb 2017. https://www.510kdatabase.net/k162018/ 2017-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k162018-surface-applicator-set-fda-510k.jpg K162018 - Surface Applicator Set K162018 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Feb 2017. https://www.510kdatabase.net/k163008/ 2017-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k163008-carelink-smartsync-device-manager-fda-510k.jpg K163008 - CareLink SmartSync Device Manager - Pacing System Analyzer K163008 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Feb 2017. https://www.510kdatabase.net/k163234/ 2017-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k163234-biograph-mmr-with-syngo-mr-e11p-system-fda-510k.jpg K163234 - Biograph mMR with syngo MR E11P system software K163234 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 2017. https://www.510kdatabase.net/k170008/ 2017-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k170008-osteo-site-bone-biopsy-needle-osteo-fda-510k.jpg K170008 - Osteo-Site Bone Biopsy Needle, Osteo-Site Bone Biopsy Needle Set K170008 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Feb 2017. https://www.510kdatabase.net/k170283/ 2017-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k170283-bd-nexiva-diffusics-closed-iv-catheter-fda-510k.jpg K170283 - BD Nexiva Diffusics Closed IV Catheter System K170283 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson and Company. Cleared Feb 2017. https://www.510kdatabase.net/k161853/ 2017-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k161853-progav-programmable-shunt-system-fda-510k.jpg K161853 - proGAV Programmable Shunt System, proGAV 2.0 Adjustable Shunt System, proSA Adjustable Shunt System K161853 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Feb 2017. https://www.510kdatabase.net/k162903/ 2017-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k162903-exactech-equinoxe-humeral-fda-510k.jpg K162903 - Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies K162903 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Feb 2017. https://www.510kdatabase.net/k162982/ 2017-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k162982-medline-nitrile-powder-free-fda-510k.jpg K162982 - Medline Nitrile Powder-Free Examination Glove with Colloidal Oatmeal USP (Tested for Use with Chemotherapy Drugs) K162982 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Feb 2017. https://www.510kdatabase.net/k163032/ 2017-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k163032-kyphon-xpede-bone-cement-fda-510k.jpg K163032 - Kyphon Xpede Bone Cement K163032 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic, Inc.. Cleared Feb 2017. https://www.510kdatabase.net/k163591/ 2017-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k163591-bd-posiflush-heparin-lock-flush-syringe-fda-510k.jpg K163591 - BD PosiFlush Heparin Lock Flush Syringe K163591 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson and Company. Cleared Feb 2017. https://www.510kdatabase.net/k162484/ 2017-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k162484-lung-nodule-assessment-and-comparison-fda-510k.jpg K162484 - Lung Nodule Assessment and Comparison Option (LNA) K162484 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Feb 2017. https://www.510kdatabase.net/k162827/ 2017-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k162827-vidas-brahms-pct-pct-fda-510k.jpg K162827 - VIDAS B.R.A.H.M.S. PCT (PCT) K162827 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Feb 2017. https://www.510kdatabase.net/k162855/ 2017-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k162855-reveal-linq-fda-510k.jpg K162855 - Reveal LINQ K162855 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Feb 2017. https://www.510kdatabase.net/k162937/ 2017-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k162937-stryker-orthomap-versatile-hip-system-fda-510k.jpg K162937 - Stryker OrthoMap Versatile Hip System K162937 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Stryker Corporation. Cleared Feb 2017. https://www.510kdatabase.net/k163279/ 2017-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k163279-medtronic-transportationsterilization-fda-510k.jpg K163279 - Medtronic Transportation/Sterilization Cassettes K163279 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Feb 2017. https://www.510kdatabase.net/k170240/ 2017-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k170240-truliant-femoral-components-fda-510k.jpg K170240 - Truliant Femoral Components K170240 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Feb 2017. https://www.510kdatabase.net/k170265/ 2017-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k170265-gravitytm-peek-optima-suture-anchor-fda-510k.jpg K170265 - GRAVITYTM PEEK-OPTIMA Suture Anchor K170265 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Feb 2017. https://www.510kdatabase.net/k152022/ 2017-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k152022-sustain-r-spacers-patriot-spacers-fda-510k.jpg K152022 - SUSTAIN® R Spacers, PATRIOT® Spacers, CALIBER® Spacers, RISE® Spacers, COALITION® Spacers, COALITION AGX™ Spacers, INDEPENDENCE® Spacers, FORTIFY®-R Corpectomy Spacers, FORTIFY® I-R Corpectomy Spacers, XPand®-R Corpectomy Spacers, NIKO® Corpectomy Spacers, MONUMENT™ Spacers, ALTERA™ Spacers, MAGNIFY™ Spacers, InterContinental® Plate-Spacer K152022 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Feb 2017. https://www.510kdatabase.net/k162795/ 2017-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k162795-prophecy-invision-preoperative-fda-510k.jpg K162795 - PROPHECY INVISION Preoperative Navigation Alignment System K162795 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Feb 2017. https://www.510kdatabase.net/k162929/ 2017-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k162929-stryker-navigation-system-with-fda-510k.jpg K162929 - Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker K162929 is a FDA 510(k) cleared neurology medical device. Manufacturer: Stryker Corporation. Cleared Feb 2017. https://www.510kdatabase.net/k170258/ 2017-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k170258-speedlyser-infusion-catheter-kit-fda-510k.jpg K170258 - SpeedLyser Infusion Catheter Kit K170258 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: AngioDynamics, Inc.. Cleared Feb 2017. https://www.510kdatabase.net/k163272/ 2017-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k163272-axios-stent-and-electrocautery-fda-510k.jpg K163272 - AXIOS Stent and Electrocautery Enhanced Delivery System K163272 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Feb 2017. https://www.510kdatabase.net/k160200/ 2017-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k160200-melker-cuffed-emergency-cricothyrotomy-fda-510k.jpg K160200 - Melker Cuffed Emergency Cricothyrotomy Catheter Sets, Melker Universal Cricothyrotomy Catheter Set K160200 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Cook Incorporated. Cleared Feb 2017. https://www.510kdatabase.net/k161411/ 2017-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k161411-care-cycle-connect-application-fda-510k.jpg K161411 - Care Cycle Connect Application K161411 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Feb 2017. https://www.510kdatabase.net/k163651/ 2017-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k163651-expressbraid-graft-manipulation-fda-510k.jpg K163651 - ExpressBraid Graft Manipulation K163651 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Biomet Manufacturing Corp. Cleared Feb 2017. https://www.510kdatabase.net/k153561/ 2017-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k153561-ag-607-blood-glucose-monitoring-system-fda-510k.jpg K153561 - AG-607 Blood Glucose Monitoring System and AG-607 Multi Blood Glucose Monitoring System K153561 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Andon Health Co, Ltd.. Cleared Feb 2017. https://www.510kdatabase.net/k161437/ 2017-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k161437-vitek-2-ast-gram-negative-cefotaxime-fda-510k.jpg K161437 - VITEK 2 AST Gram Negative Cefotaxime (<=0.25 - >=64 ug/mL) K161437 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Feb 2017. https://www.510kdatabase.net/k163165/ 2017-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k163165-am-100-fda-510k.jpg K163165 - AM-100 K163165 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: BTL Industries, Inc.. Cleared Feb 2017. https://www.510kdatabase.net/k170170/ 2017-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k170170-valleylab-ft10-electrosurgical-platform-fda-510k.jpg K170170 - Valleylab FT10 Electrosurgical Platform K170170 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien, LLC. Cleared Feb 2017. https://www.510kdatabase.net/k160876/ 2017-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k160876-pc-ecg-fda-510k.jpg K160876 - PC ECG K160876 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edan Instruments, Inc.. Cleared Feb 2017. https://www.510kdatabase.net/k170160/ 2017-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k170160-abbott-architect-free-t3-fda-510k.jpg K170160 - Abbott ARCHITECT Free T3 K170160 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Feb 2017. https://www.510kdatabase.net/k162668/ 2017-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k162668-fully-automatic-electronic-blood-fda-510k.jpg K162668 - Fully Automatic Electronic Blood Pressure Monitor K162668 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Andon Health Co, Ltd.. Cleared Feb 2017. https://www.510kdatabase.net/k163460/ 2017-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k163460-reveal-linq-insertable-cardiac-monitor-fda-510k.jpg K163460 - Reveal LINQ Insertable Cardiac Monitor K163460 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Feb 2017. https://www.510kdatabase.net/k163619/ 2017-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k163619-signa-petmr-fda-510k.jpg K163619 - SIGNA PET/MR K163619 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems, LLC. Cleared Feb 2017. https://www.510kdatabase.net/k161510/ 2017-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k161510-vtek-2-ast-gn-ceftolozanetazobactam-fda-510k.jpg K161510 - VTEK 2 AST-GN Ceftolozane/Tazobactam (<=0.25 - >= 32 mcg/mL) K161510 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Feb 2017. https://www.510kdatabase.net/k170193/ 2017-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k170193-advance-14lp-low-profile-pta-balloon-fda-510k.jpg K170193 - Advance 14LP Low Profile PTA Balloon Dilatation Catheter K170193 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Feb 2017. https://www.510kdatabase.net/k162774/ 2017-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k162774-myotherm-xp-cardioplegia-delivery-fda-510k.jpg K162774 - MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface (Bridge System) K162774 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Feb 2017. https://www.510kdatabase.net/k163217/ 2017-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k163217-gore-bio-a-tissue-reinforcement-fda-510k.jpg K163217 - GORE BIO-A Tissue Reinforcement K163217 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Feb 2017. https://www.510kdatabase.net/k163596/ 2017-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k163596-logiq-p9-and-logiq-p7-fda-510k.jpg K163596 - LOGIQ P9 and LOGIQ P7 K163596 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Feb 2017. https://www.510kdatabase.net/k163341/ 2017-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k163341-syngoct-extended-functionality-fda-510k.jpg K163341 - syngo.CT Extended Functionality K163341 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 2017. https://www.510kdatabase.net/k163478/ 2017-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k163478-acunav-volume-ice-catheter-fda-510k.jpg K163478 - AcuNav Volume ICE Catheter K163478 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 2017. https://www.510kdatabase.net/k170086/ 2017-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k170086-pinnacle-radiation-therapy-planning-fda-510k.jpg K170086 - Pinnacle Radiation Therapy Planning System K170086 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Feb 2017. https://www.510kdatabase.net/k162840/ 2017-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k162840-elecsys-vitamin-d-total-ii-vitamin-d-fda-510k.jpg K162840 - Elecsys Vitamin D total II, Vitamin D total II CalSet, PreciControl Vitamin D total II, Vitamin D CalCheck 5 K162840 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Feb 2017. https://www.510kdatabase.net/k162915/ 2017-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k162915-fully-automatic-electronic-blood-fda-510k.jpg K162915 - Fully Automatic Electronic Blood Pressure Monitor K162915 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Andon Health Co, Ltd.. Cleared Feb 2017. https://www.510kdatabase.net/k162973/ 2017-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k162973-endowrist-suction-irrigator-fda-510k.jpg K162973 - EndoWrist Suction Irrigator K162973 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Feb 2017. https://www.510kdatabase.net/k163294/ 2017-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k163294-syngomr-general-syngomr-cardiology-fda-510k.jpg K163294 - syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology K163294 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 2017. https://www.510kdatabase.net/k170330/ 2017-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k170330-3m-protemp-cement-temporary-dental-fda-510k.jpg K170330 - 3M Protemp Cement Temporary Dental Cement K170330 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Feb 2017. https://www.510kdatabase.net/k161056/ 2017-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k161056-telemetry-transmitter-fda-510k.jpg K161056 - Telemetry Transmitter K161056 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edan Instruments, Inc.. Cleared Feb 2017. https://www.510kdatabase.net/k161258/ 2017-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k161258-nova-lite-dapi-anca-ethanol-kit-nova-fda-510k.jpg K161258 - NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit K161258 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Feb 2017. https://www.510kdatabase.net/k161901/ 2017-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k161901-trapliner-catheter-fda-510k.jpg K161901 - TrapLiner catheter K161901 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vascular Solutions, Inc.. Cleared Feb 2017. https://www.510kdatabase.net/k161552/ 2017-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k161552-09-sodium-chloride-injection-usp-bd-fda-510k.jpg K161552 - 0.9% Sodium Chloride Injection, USP BD PosiFlush SP Syringe K161552 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson and Company. Cleared Feb 2017. https://www.510kdatabase.net/k170019/ 2017-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k170019-aquilion-lightning-tsx-036a1-v84-fda-510k.jpg K170019 - Aquilion Lightning, TSX-036A/1, V8.4 K170019 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshibamedical Systems Corporation. Cleared Feb 2017. https://www.510kdatabase.net/k161279/ 2017-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k161279-life-spine-metatarsal-hemi-implant-fda-510k.jpg K161279 - Life Spine Metatarsal Hemi Implant K161279 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Life Spine, Inc.. Cleared Feb 2017. https://www.510kdatabase.net/k162144/ 2017-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k162144-ihealth-wireless-blood-pressure-monitor-fda-510k.jpg K162144 - iHealth Wireless Blood Pressure Monitor K162144 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Andon Health Co, Ltd.. Cleared Feb 2017. https://www.510kdatabase.net/k162467/ 2017-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k162467-twin-pass-torque-fda-510k.jpg K162467 - Twin-Pass Torque K162467 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vascular Solutions, Inc.. Cleared Feb 2017. https://www.510kdatabase.net/k162726/ 2017-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k162726-exactech-equinoxe-preserve-stem-fda-510k.jpg K162726 - Exactech® Equinoxe® Preserve Stem K162726 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Feb 2017. https://www.510kdatabase.net/k162958/ 2017-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k162958-myotherm-xp-cardioplegia-delivery-fda-510k.jpg K162958 - MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface K162958 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Feb 2017. https://www.510kdatabase.net/k163083/ 2017-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k163083-vitek-2-ast-gn-tobramycin-1-16-ugml-fda-510k.jpg K163083 - VITEK 2 AST-GN Tobramycin (</=1->/= 16 ug/mL) K163083 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Feb 2017. https://www.510kdatabase.net/k160471/ 2017-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k160471-medline-non-surgical-isolation-gown--fda-510k.jpg K160471 - Medline Non-Surgical Isolation Gown- K160471 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Jan 2017. https://www.510kdatabase.net/k162055/ 2017-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k162055-acclarix-lx8-diagnostic-ultrasound-fda-510k.jpg K162055 - Acclarix LX8 Diagnostic Ultrasound System K162055 is a FDA 510(k) cleared radiology medical device. Manufacturer: Edan Instruments, Inc.. Cleared Jan 2017. https://www.510kdatabase.net/k163122/ 2017-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k163122-nobelclinician-dtx-studio-implant-fda-510k.jpg K163122 - NobelClinician, DTX Studio implant K163122 is a FDA 510(k) cleared radiology medical device. Manufacturer: Nobel Biocare AB. Cleared Jan 2017. https://www.510kdatabase.net/k163542/ 2017-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k163542-cardiosave-hybrid-and-rescue-intra-fda-510k.jpg K163542 - CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage Case K163542 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Jan 2017. https://www.510kdatabase.net/k161236/ 2017-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k161236-universa-firm-ureteral-stents-and-fda-510k.jpg K161236 - Universa Firm Ureteral Stents and Stent Sets K161236 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Jan 2017. https://www.510kdatabase.net/k162631/ 2017-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k162631-verify-steam-integrating-indicator-short-fda-510k.jpg K162631 - VERIFY STEAM Integrating Indicator - Short K162631 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Jan 2017. https://www.510kdatabase.net/k162842/ 2017-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k162842-asahi-ptca-guide-wire-asahi-suoh-03-fda-510k.jpg K162842 - ASAHI PTCA Guide Wire ASAHI SUOH 03 K162842 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Asahi Intecc Co., Ltd.. Cleared Jan 2017. https://www.510kdatabase.net/k163042/ 2017-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k163042-chromid-strepto-b-agar-fda-510k.jpg K163042 - chromID Strepto B agar K163042 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jan 2017. https://www.510kdatabase.net/k163211/ 2017-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k163211-magnetom-sempra-with-syngo-mr-e11s-fda-510k.jpg K163211 - MAGNETOM Sempra with syngo MR E11S K163211 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 2017. https://www.510kdatabase.net/k163312/ 2017-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k163312-magnetom-aera-and-magnetom-skyra-with-fda-510k.jpg K163312 - MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software K163312 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 2017. https://www.510kdatabase.net/k162882/ 2017-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k162882-karl-storz-icg-imaging-system-fda-510k.jpg K162882 - KARL STORZ ICG Imaging System K162882 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jan 2017. https://www.510kdatabase.net/k163044/ 2017-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k163044-ortholoc-3di-ankle-fracture-plating-fda-510k.jpg K163044 - ORTHOLOC® 3Di Ankle Fracture Plating System K163044 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jan 2017. https://www.510kdatabase.net/k163660/ 2017-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k163660-pantera-leo-fda-510k.jpg K163660 - Pantera LEO K163660 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biotronik, Inc.. Cleared Jan 2017. https://www.510kdatabase.net/k163693/ 2017-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k163693-intraclude-intra-aortic-occlusion-device-fda-510k.jpg K163693 - IntraClude Intra-Aortic Occlusion Device K163693 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Jan 2017. https://www.510kdatabase.net/k163715/ 2017-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k163715-allura-xper-r9-fda-510k.jpg K163715 - Allura Xper R9 K163715 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Jan 2017. https://www.510kdatabase.net/k161273/ 2017-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k161273-stageone-disposable-cement-spacer-fda-510k.jpg K161273 - StageOne Disposable Cement Spacer Molds for Temporary Knee Prosthesis K161273 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jan 2017. https://www.510kdatabase.net/k162988/ 2017-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k162988-preludesync-radial-compression-device-fda-510k.jpg K162988 - PreludeSYNC Radial Compression Device K162988 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jan 2017. https://www.510kdatabase.net/k163258/ 2017-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k163258-crossft-knotless-suture-anchor-with-fda-510k.jpg K163258 - CrossFT Knotless Suture Anchor with Disposable Driver K163258 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Conmed Corporation. Cleared Jan 2017. https://www.510kdatabase.net/k162802/ 2017-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k162802-barrx-anorectal-rfa-wand-fda-510k.jpg K162802 - Barrx Anorectal RFA Wand K162802 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Covidien, LLC. Cleared Jan 2017. https://www.510kdatabase.net/k163006/ 2017-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k163006-vitek-2-ast-gn-tigecycline-05-8-ugml-fda-510k.jpg K163006 - VITEK 2 AST-GN Tigecycline (<0.5->8 ug/mL) K163006 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jan 2017. https://www.510kdatabase.net/k162606/ 2017-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k162606-elecsys-tsh-assay-cobas-e-801-fda-510k.jpg K162606 - Elecsys TSH assay, cobas e 801 Immunoassay analyzer K162606 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Jan 2017. https://www.510kdatabase.net/k162618/ 2017-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k162618-concord-plus-radiopaque-bone-cement-fda-510k.jpg K162618 - CONCORD Plus Radiopaque Bone Cement K162618 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Jan 2017. https://www.510kdatabase.net/k160660/ 2017-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k160660-medline-waste-station-fda-510k.jpg K160660 - Medline Waste Station K160660 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medline Industries, Inc.. Cleared Jan 2017. https://www.510kdatabase.net/k161178/ 2017-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k161178-da-vinci-xi-surgical-system-fda-510k.jpg K161178 - da Vinci Xi Surgical System K161178 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Jan 2017. https://www.510kdatabase.net/k161492/ 2017-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k161492-juno-vpap-st-a-fda-510k.jpg K161492 - Juno VPAP ST-A K161492 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Resmed, Ltd.. Cleared Jan 2017. https://www.510kdatabase.net/k162399/ 2017-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k162399-atellica-ch-magnesium-mg-fda-510k.jpg K162399 - Atellica CH Magnesium (Mg) K162399 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Jan 2017. https://www.510kdatabase.net/k162472/ 2017-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k162472-truebeam-truebeam-stx-edge-fda-510k.jpg K162472 - TrueBeam-TrueBeam STx-Edge K162472 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Jan 2017. https://www.510kdatabase.net/k163069/ 2017-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k163069-olympus-small-intestinal-capsule-fda-510k.jpg K163069 - OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM K163069 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Medical Systems Corp.. Cleared Jan 2017. https://www.510kdatabase.net/k163620/ 2017-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k163620-reprocessed-kendall-scd-express-fda-510k.jpg K163620 - Reprocessed Kendall SCD Express Compression Sleeves, Reprocessed Kendall SCD Comfort Compression Sleeves K163620 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Covidien. Cleared Jan 2017. https://www.510kdatabase.net/k162895/ 2017-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k162895-elecsys-troponin-t-gen-5-stat-assay-fda-510k.jpg K162895 - Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5 K162895 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Jan 2017. https://www.510kdatabase.net/k161514/ 2017-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k161514-precision-thin-reciprocating-blade-fda-510k.jpg K161514 - Precision Thin Reciprocating Blade, 0.010in. K161514 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Stryker Corporation. Cleared Jan 2017. https://www.510kdatabase.net/k162775/ 2017-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k162775-legion-cone-system-fda-510k.jpg K162775 - Legion Cone System K162775 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jan 2017. https://www.510kdatabase.net/k161217/ 2017-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k161217-vitek-2-gram-negative-ceftriaxone-025-fda-510k.jpg K161217 - VITEK 2 Gram Negative Ceftriaxone (<=0.25->=64 ug/mL) K161217 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jan 2017. https://www.510kdatabase.net/k162173/ 2017-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k162173-elecsys-cyfra-21-1-calcheck-5-fda-510k.jpg K162173 - Elecsys CYFRA 21-1 CalCheck 5 K162173 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics. Cleared Jan 2017. https://www.510kdatabase.net/k163252/ 2017-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k163252-mammomat-fusion-with-stereotactic-biopsy-fda-510k.jpg K163252 - Mammomat Fusion with Stereotactic Biopsy K163252 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 2017. https://www.510kdatabase.net/k162208/ 2017-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k162208-dxc-700-au-clinical-chemistry-analyzer-fda-510k.jpg K162208 - DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent K162208 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jan 2017. https://www.510kdatabase.net/k162483/ 2017-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k162483-symbia-intevo-bold-fda-510k.jpg K162483 - Symbia Intevo Bold K162483 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 2017. https://www.510kdatabase.net/k161504/ 2017-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k161504-cook-turbo-flo-hd-acute-hemodialysis-fda-510k.jpg K161504 - Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray K161504 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Jan 2017. https://www.510kdatabase.net/k162931/ 2017-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k162931-ingenia-15t-cx-and-ingenia-30t-cx-r53-fda-510k.jpg K162931 - Ingenia 1.5T CX and Ingenia 3.0T CX R5.3 K162931 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Jan 2017. https://www.510kdatabase.net/k163116/ 2017-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k163116-ingenia-15t-ingenia-15t-s-and-ingenia-fda-510k.jpg K163116 - Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 K163116 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems Nederland B.V.. Cleared Jan 2017. https://www.510kdatabase.net/k163141/ 2017-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k163141-namic-clearacil-contrast-injection-lines-fda-510k.jpg K163141 - NAMIC ClearaCIL Contrast Injection Lines K163141 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: AngioDynamics, Inc.. Cleared Jan 2017. https://www.510kdatabase.net/k163444/ 2017-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k163444-spectre-guidewire-fda-510k.jpg K163444 - Spectre guidewire K163444 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Vascular Solutions, Inc.. Cleared Jan 2017. https://www.510kdatabase.net/k163492/ 2017-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k163492-oracle-eus-balloon-fda-510k.jpg K163492 - Oracle EUS Balloon K163492 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: United States Endoscopy Group, Inc.. Cleared Jan 2017. https://www.510kdatabase.net/k162563/ 2017-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k162563-yoga-microcatheter-fda-510k.jpg K162563 - YOGA Microcatheter K162563 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Jan 2017. https://www.510kdatabase.net/k163396/ 2017-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k163396-acuson-p500-ultrasound-system-fda-510k.jpg K163396 - ACUSON P500 Ultrasound System K163396 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 2017. https://www.510kdatabase.net/k162084/ 2017-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k162084-moto-partial-knee-system-fda-510k.jpg K162084 - MOTO Partial Knee System K162084 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Jan 2017. https://www.510kdatabase.net/k163421/ 2017-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k163421-syngovia-mi-workflows-fda-510k.jpg K163421 - syngo.via MI Workflows K163421 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 2017. https://www.510kdatabase.net/k162686/ 2016-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k162686-kuschall-champion-manual-wheelchair-fda-510k.jpg K162686 - Kuschall Champion Manual Wheelchair K162686 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Invacare Corporation. Cleared Dec 2016. https://www.510kdatabase.net/k162692/ 2016-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k162692-kuschall-k-series-attract-manual-fda-510k.jpg K162692 - Kuschall K-Series Attract Manual Wheelchair K162692 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Invacare Corporation. Cleared Dec 2016. https://www.510kdatabase.net/k162696/ 2016-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k162696-kuschall-advance-manual-wheelchair-fda-510k.jpg K162696 - Kuschall Advance Manual Wheelchair K162696 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Invacare Corporation. Cleared Dec 2016. https://www.510kdatabase.net/k160538/ 2016-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k160538-sysmex-xn-l-automated-hematology-fda-510k.jpg K160538 - Sysmex XN-L Automated Hematology Analyzer K160538 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sysmex America, Inc.. Cleared Dec 2016. https://www.510kdatabase.net/k160585/ 2016-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k160585-xn-cal-fda-510k.jpg K160585 - XN CAL K160585 is a FDA 510(k) cleared hematology medical device. Manufacturer: Streck. Cleared Dec 2016. https://www.510kdatabase.net/k160586/ 2016-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k160586-xn-l-check-fda-510k.jpg K160586 - XN-L CHECK K160586 is a FDA 510(k) cleared hematology medical device. Manufacturer: Streck. Cleared Dec 2016. https://www.510kdatabase.net/k160588/ 2016-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k160588-xn-check-bf-fda-510k.jpg K160588 - XN CHECK BF K160588 is a FDA 510(k) cleared hematology medical device. Manufacturer: Streck. Cleared Dec 2016. https://www.510kdatabase.net/k160590/ 2016-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k160590-xn-check-fda-510k.jpg K160590 - XN CHECK K160590 is a FDA 510(k) cleared hematology medical device. Manufacturer: Streck. Cleared Dec 2016. https://www.510kdatabase.net/k163086/ 2016-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k163086-vlp-mini-mod-20mm-column-plates-fda-510k.jpg K163086 - VLP MINI-MOD 2.0mm Column Plates K163086 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Dec 2016. https://www.510kdatabase.net/k163311/ 2016-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k163311-gmk-revision-femoral-distal-augmentation-fda-510k.jpg K163311 - GMK Revision Femoral Distal Augmentation K163311 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Dec 2016. https://www.510kdatabase.net/k163301/ 2016-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k163301-cd-horizon-spinal-system-fda-510k.jpg K163301 - CD HORIZON® Spinal System K163301 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Dec 2016. https://www.510kdatabase.net/den150057/ 2016-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/den150057-elecsys-amh-amh-calset-precicontrol-fda-510k.jpg DEN150057 - Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5 DEN150057 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Dec 2016. https://www.510kdatabase.net/k161837/ 2016-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k161837-ise-reagent-glucose-crp-latex-dxc-700-fda-510k.jpg K161837 - ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer K161837 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Dec 2016. https://www.510kdatabase.net/k162302/ 2016-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k162302-somatom-confidence-rt-pro-fda-510k.jpg K162302 - Somatom Confidence ® RT Pro K162302 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Dec 2016. https://www.510kdatabase.net/k161060/ 2016-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k161060-arthrex-ibalance-uka-system-vitamin-e-fda-510k.jpg K161060 - Arthrex iBalance UKA System Vitamin E Tibial Bearing K161060 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Dec 2016. https://www.510kdatabase.net/k162845/ 2016-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k162845-dc-40dc-35dc-45dc-40sdc-40-pro-fda-510k.jpg K162845 - DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System K162845 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Dec 2016. https://www.510kdatabase.net/k160225/ 2016-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k160225-gem-premier-5000-measured-fda-510k.jpg K160225 - GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator K160225 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Dec 2016. https://www.510kdatabase.net/k160402/ 2016-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k160402-gem-premier-5000-measured-fda-510k.jpg K160402 - GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin) K160402 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Dec 2016. https://www.510kdatabase.net/k160412/ 2016-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k160412-gem-premier-5000-measured-parameters-fda-510k.jpg K160412 - GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2) K160412 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Dec 2016. https://www.510kdatabase.net/k160415/ 2016-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k160415-gem-premier-5000-measured-parameters-fda-510k.jpg K160415 - GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation) K160415 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Dec 2016. https://www.510kdatabase.net/k160915/ 2016-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k160915-elecsys-cyfra-21-1-elecsys-cyfra-21-1-fda-510k.jpg K160915 - Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker K160915 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics. Cleared Dec 2016. https://www.510kdatabase.net/k161233/ 2016-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k161233-oxinium-dh-fermoral-heads-fda-510k.jpg K161233 - OXINIUM DH Fermoral Heads K161233 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Dec 2016. https://www.510kdatabase.net/k162680/ 2016-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k162680-sovereign-spinal-system-fda-510k.jpg K162680 - SOVEREIGN® Spinal System K162680 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Dec 2016. https://www.510kdatabase.net/k162900/ 2016-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k162900-powermidline-catheter-fda-510k.jpg K162900 - PowerMidline Catheter K162900 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 2016. https://www.510kdatabase.net/k163174/ 2016-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k163174-emerge-ptca-dilatation-catheter-fda-510k.jpg K163174 - Emerge PTCA Dilatation Catheter K163174 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Dec 2016. https://www.510kdatabase.net/k163200/ 2016-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k163200-maverick-xl-percutaneous-transluminal-fda-510k.jpg K163200 - Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Cathete K163200 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Dec 2016. https://www.510kdatabase.net/k162476/ 2016-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k162476-varian-high-energy-linear-accelerator-fda-510k.jpg K162476 - Varian High Energy Linear Accelerator K162476 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Dec 2016. https://www.510kdatabase.net/k162829/ 2016-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k162829-medline-unite-ankle-fracture-plating-fda-510k.jpg K162829 - Medline UNITE® Ankle Fracture Plating System K162829 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medline Industries, Inc.. Cleared Dec 2016. https://www.510kdatabase.net/k162896/ 2016-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k162896-affinity-nt-oxygenator-affinity-nt-fda-510k.jpg K162896 - Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface K162896 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Dec 2016. https://www.510kdatabase.net/k160642/ 2016-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k160642-medline-enfit-syringe-fda-510k.jpg K160642 - Medline ENFit Syringe K160642 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medline Industries, Inc.. Cleared Nov 2016. https://www.510kdatabase.net/k162414/ 2016-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k162414-unicel-dxh-slidemaker-stainer-coulter-fda-510k.jpg K162414 - UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System K162414 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Nov 2016. https://www.510kdatabase.net/k161962/ 2016-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k161962-vamp-venousarterial-blood-management-fda-510k.jpg K161962 - VAMP Venous/Arterial Blood Management Protection System K161962 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Nov 2016. https://www.510kdatabase.net/k163207/ 2016-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k163207-filtek-one-bulk-fill-restorative-fda-510k.jpg K163207 - Filtek One Bulk Fill Restorative K163207 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Nov 2016. https://www.510kdatabase.net/k161264/ 2016-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k161264-trigen-low-profile-bone-screws-fda-510k.jpg K161264 - TRIGEN Low Profile Bone Screws K161264 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Nov 2016. https://www.510kdatabase.net/k160884/ 2016-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k160884-cxi-support-catheter-fda-510k.jpg K160884 - CXI Support Catheter K160884 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Nov 2016. https://www.510kdatabase.net/k161763/ 2016-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k161763-smith-nephew-truclear-ultra-mini-fda-510k.jpg K161763 - Smith & Nephew TRUCLEAR ULTRA Mini Tissue Removal Device K161763 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Nov 2016. https://www.510kdatabase.net/k162971/ 2016-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k162971-multix-fusion-max-fda-510k.jpg K162971 - Multix Fusion Max K162971 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2016. https://www.510kdatabase.net/k161782/ 2016-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k161782-arthrex-univers-revers-shoulder-fda-510k.jpg K161782 - Arthrex Univers Revers Shoulder Prosthesis System K161782 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Nov 2016. https://www.510kdatabase.net/k160933/ 2016-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k160933-discovery-nm-750b-bopsy-fda-510k.jpg K160933 - Discovery NM 750b Bopsy K160933 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Nov 2016. https://www.510kdatabase.net/k161795/ 2016-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k161795-magnetom-essenza-fda-510k.jpg K161795 - MAGNETOM ESSENZA K161795 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2016. https://www.510kdatabase.net/k162078/ 2016-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k162078-evos-small-fragment-plating-system-fda-510k.jpg K162078 - EVOS Small Fragment Plating System K162078 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Nov 2016. https://www.510kdatabase.net/k160045/ 2016-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k160045-heyman-packing-applicator-set-fda-510k.jpg K160045 - Heyman Packing Applicator Set K160045 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Nov 2016. https://www.510kdatabase.net/k160923/ 2016-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k160923-redapt-anteverted-cemented-liner-fda-510k.jpg K160923 - REDAPT Anteverted Cemented Liner K160923 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Nov 2016. https://www.510kdatabase.net/k162097/ 2016-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k162097-intrakit-fda-510k.jpg K162097 - InTRAkit K162097 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Nov 2016. https://www.510kdatabase.net/k162379/ 2016-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k162379-cd-horizon-spinal-system-fda-510k.jpg K162379 - CD HORIZON® Spinal System K162379 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Nov 2016. https://www.510kdatabase.net/k162541/ 2016-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k162541-syngo-application-software-fda-510k.jpg K162541 - syngo Application Software K162541 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2016. https://www.510kdatabase.net/k161494/ 2016-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k161494-atellica-ch-creatinine2-crea2-atellica-fda-510k.jpg K161494 - Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) K161494 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Nov 2016. https://www.510kdatabase.net/k161665/ 2016-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k161665-vlp-wrist-fracture-system-fda-510k.jpg K161665 - VLP Wrist Fracture System K161665 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Nov 2016. https://www.510kdatabase.net/k162892/ 2016-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k162892-achieve-advance-mapping-catheter-fda-510k.jpg K162892 - Achieve Advance Mapping Catheter K162892 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Nov 2016. https://www.510kdatabase.net/k162894/ 2016-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k162894-accucath-intravascular-catheter-fda-510k.jpg K162894 - AccuCath Intravascular Catheter K162894 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 2016. https://www.510kdatabase.net/k161623/ 2016-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k161623-prontosan-wound-irrigation-solution-40-fda-510k.jpg K161623 - Prontosan Wound Irrigation Solution, 40 mL, Prontosan Wound Irrigation Solution, 350 mL, Prontosan Wound Irrigation Solution, 1000 mL K161623 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Nov 2016. https://www.510kdatabase.net/k161921/ 2016-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k161921-swiftninja-microcatheter-fda-510k.jpg K161921 - SwiftNINJA Microcatheter K161921 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Nov 2016. https://www.510kdatabase.net/k162350/ 2016-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k162350-coyote-monorail-percutaneous-fda-510k.jpg K162350 - Coyote Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Express SD Biliary Monorail Premounted Stent System, Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Catheter, Sterling Monorail Percutaneous Transluminal Angioplasty Balloon Dilatation Catheter, Ultra-Soft SV Monorail Balloon Dilatation Catheter 0.018 K162350 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Nov 2016. https://www.510kdatabase.net/k162769/ 2016-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k162769-pinpoint-gt-introducer-needle-fda-510k.jpg K162769 - Pinpoint GT Introducer Needle K162769 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 2016. https://www.510kdatabase.net/k161592/ 2016-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k161592-persona-partial-knee-system-fda-510k.jpg K161592 - Persona Partial Knee System K161592 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Nov 2016. https://www.510kdatabase.net/k162268/ 2016-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k162268-senographe-pristina-fda-510k.jpg K162268 - Senographe Pristina K162268 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Nov 2016. https://www.510kdatabase.net/k161974/ 2016-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k161974-slendertone-connect-abs-type-570-fda-510k.jpg K161974 - SLENDERTONE® Connect Abs, Type 570 K161974 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Bio-Medical Research, Ltd.. Cleared Nov 2016. https://www.510kdatabase.net/k162777/ 2016-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k162777-squirt-fluid-delivery-system-fda-510k.jpg K162777 - Squirt Fluid Delivery System K162777 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Oct 2016. https://www.510kdatabase.net/k162437/ 2016-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k162437-codman-eds3-csf-external-drainage-system-fda-510k.jpg K162437 - Codman EDS3 CSF External Drainage System K162437 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Oct 2016. https://www.510kdatabase.net/k160885/ 2016-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k160885-hemosil-d-dimer-hs-fda-510k.jpg K160885 - HemosIL D-Dimer HS K160885 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Oct 2016. https://www.510kdatabase.net/k161822/ 2016-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k161822-torcon-nb-advantage-catheters-fda-510k.jpg K161822 - Torcon NB Advantage Catheters K161822 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Oct 2016. https://www.510kdatabase.net/k161830/ 2016-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k161830-zimmer-ml-taper-hip-prosthesis-fda-510k.jpg K161830 - Zimmer M/L Taper Hip Prosthesis K161830 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Oct 2016. https://www.510kdatabase.net/k162076/ 2016-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k162076-chromid-mrsa-fda-510k.jpg K162076 - chromID MRSA K162076 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Oct 2016. https://www.510kdatabase.net/k162370/ 2016-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k162370-syngovia-rt-image-suite-fda-510k.jpg K162370 - syngo.via RT Image Suite K162370 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 2016. https://www.510kdatabase.net/k162443/ 2016-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k162443-powerpicc-provena-catheters-fda-510k.jpg K162443 - PowerPICC Provena Catheters K162443 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 2016. https://www.510kdatabase.net/k162736/ 2016-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k162736-biograph-horizon-petct-and-biograph-fda-510k.jpg K162736 - Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT K162736 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 2016. https://www.510kdatabase.net/k160992/ 2016-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k160992-hpm-6000-fda-510k.jpg K160992 - HPM-6000 K160992 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: BTL Industries, Inc.. Cleared Oct 2016. https://www.510kdatabase.net/k161555/ 2016-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k161555-karl-storz-nav1-electromagnetic-fda-510k.jpg K161555 - KARL STORZ NAV1 Electromagnetic Navigation System K161555 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Oct 2016. https://www.510kdatabase.net/k162027/ 2016-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k162027-tracelet-compression-device-fda-510k.jpg K162027 - TRAcelet Compression Device K162027 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Oct 2016. https://www.510kdatabase.net/k162061/ 2016-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k162061-must-pedicle-screw-system-fda-510k.jpg K162061 - M.U.S.T. Pedicle Screw System K162061 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Oct 2016. https://www.510kdatabase.net/k161540/ 2016-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k161540-advanced-breast-template-system-fda-510k.jpg K161540 - Advanced Breast Template System K161540 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Oct 2016. https://www.510kdatabase.net/k161473/ 2016-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k161473-medline-powder-free-nitrile-exam-glove-fda-510k.jpg K161473 - Medline Powder-Free Nitrile Exam Glove Extended Cuff (Tested for Use with Chemotherapy Dr) K161473 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Oct 2016. https://www.510kdatabase.net/k162054/ 2016-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k162054-medtronic-temporary-external-pacemaker-fda-510k.jpg K162054 - Medtronic Temporary External Pacemaker 53401 K162054 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Oct 2016. https://www.510kdatabase.net/k161714/ 2016-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k161714-immunalysis-barbiturates-urine-enzyme-fda-510k.jpg K161714 - Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators K161714 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Immunalysis Corporation. Cleared Oct 2016. https://www.510kdatabase.net/k161964/ 2016-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k161964-advia-centaur-hav-igm-assay-fda-510k.jpg K161964 - ADVIA Centaur HAV IgM Assay K161964 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Oct 2016. https://www.510kdatabase.net/k162404/ 2016-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k162404-express-sd-biliary-monorail-premounted-fda-510k.jpg K162404 - Express SD Biliary Monorail Premounted Stent System K162404 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Oct 2016. https://www.510kdatabase.net/k162424/ 2016-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k162424-ulna-plating-system-fda-510k.jpg K162424 - Ulna Plating System K162424 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Oct 2016. https://www.510kdatabase.net/k162550/ 2016-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k162550-medtronic-model-5392-external-pulse-fda-510k.jpg K162550 - Medtronic Model 5392 External Pulse Generator (EPG) K162550 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Oct 2016. https://www.510kdatabase.net/k160912/ 2016-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k160912-sterilization-tray-fda-510k.jpg K160912 - Sterilization Tray K160912 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Oct 2016. https://www.510kdatabase.net/k161496/ 2016-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k161496-turbo-flo-picc-sets-fda-510k.jpg K161496 - Turbo-Flo PICC Sets K161496 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cook Incorporated. Cleared Oct 2016. https://www.510kdatabase.net/k160217/ 2016-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k160217-uvue-hsgshg-catheter-fda-510k.jpg K160217 - uVue HSG/SHG Catheter K160217 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Cook Incorporated. Cleared Oct 2016. https://www.510kdatabase.net/k162494/ 2016-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k162494-cd-horizon-spinal-system-fda-510k.jpg K162494 - CD HORIZON® Spinal System K162494 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Oct 2016. https://www.510kdatabase.net/k162269/ 2016-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k162269-voluson-e6-voluson-e8-voluson-e10-fda-510k.jpg K162269 - Voluson E6, Voluson E8, Voluson E10 K162269 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Oct 2016. https://www.510kdatabase.net/k161576/ 2016-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k161576-esophagus-bougie-set-fda-510k.jpg K161576 - Esophagus Bougie Set K161576 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Oct 2016. https://www.510kdatabase.net/k151964/ 2016-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k151964-xprecia-stride-coagulation-system-fda-510k.jpg K151964 - Xprecia Stride Coagulation System, Xprecia System PT Controls K151964 is a FDA 510(k) cleared hematology medical device. Manufacturer: Siemens Healthcare Diagnostics. Cleared Sep 2016. https://www.510kdatabase.net/k152163/ 2016-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k152163-renasys-go-fda-510k.jpg K152163 - RENASYS GO K152163 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Sep 2016. https://www.510kdatabase.net/k161379/ 2016-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k161379-elsa-spacers-fda-510k.jpg K161379 - ELSA Spacers K161379 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Sep 2016. https://www.510kdatabase.net/k161424/ 2016-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k161424-phasix-mesh-fda-510k.jpg K161424 - Phasix Mesh K161424 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Sep 2016. https://www.510kdatabase.net/k161002/ 2016-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k161002-aprima-smartesis-centesis-pump-fda-510k.jpg K161002 - Aprima Smartesis Centesis Pump K161002 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cook Incorporated. Cleared Sep 2016. https://www.510kdatabase.net/k153761/ 2016-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k153761-emergency-transtracheal-airway-catheter-fda-510k.jpg K153761 - Emergency Transtracheal Airway Catheter K153761 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Cook Incorporated. Cleared Sep 2016. https://www.510kdatabase.net/k162377/ 2016-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k162377-powerglide-pro-midline-catheter-fda-510k.jpg K162377 - PowerGlide Pro Midline Catheter K162377 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Sep 2016. https://www.510kdatabase.net/k161591/ 2016-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k161591-quartex-occipito-cervico-thoracic-fda-510k.jpg K161591 - QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments K161591 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Sep 2016. https://www.510kdatabase.net/k162016/ 2016-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k162016-affinity-nt-oxygenator-with-cortiva-fda-510k.jpg K162016 - Affinity NT Oxygenator with Cortiva BioActive Surface K162016 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Sep 2016. https://www.510kdatabase.net/k162339/ 2016-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k162339-scenium-fda-510k.jpg K162339 - Scenium K162339 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 2016. https://www.510kdatabase.net/k162411/ 2016-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k162411-da-vinci-xi-12-8-mm-reducer-fda-510k.jpg K162411 - da Vinci Xi 12 – 8 mm Reducer K162411 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Sep 2016. https://www.510kdatabase.net/k161112/ 2016-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k161112-karl-storz-flexible-video-neuro-fda-510k.jpg K161112 - KARL STORZ Flexible Video-Neuro-Endoscope System K161112 is a FDA 510(k) cleared neurology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Sep 2016. https://www.510kdatabase.net/k162012/ 2016-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k162012-carescape-central-station-v2-fda-510k.jpg K162012 - CARESCAPE Central Station V2 K162012 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Healthcare. Cleared Sep 2016. https://www.510kdatabase.net/k161818/ 2016-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k161818-gem-premier-3000-fda-510k.jpg K161818 - GEM Premier 3000 K161818 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 2016. https://www.510kdatabase.net/k161581/ 2016-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k161581-arthrex-synergy-rf-system-fda-510k.jpg K161581 - Arthrex Synergy RF System K161581 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Arthrex, Inc.. Cleared Sep 2016. https://www.510kdatabase.net/k161166/ 2016-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k161166-stageone-select-cement-spacer-molds-fda-510k.jpg K161166 - StageOne Select Cement Spacer Molds for Temporary Hip Replacement K161166 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Sep 2016. https://www.510kdatabase.net/k162337/ 2016-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k162337-symbia-65-fda-510k.jpg K162337 - Symbia 6.5 K162337 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 2016. https://www.510kdatabase.net/k160724/ 2016-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k160724-advia-chemistry-creatine-kinase-ckl-fda-510k.jpg K160724 - ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator K160724 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Sep 2016. https://www.510kdatabase.net/k162267/ 2016-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k162267-resona-7resona-7cvresona-7expresona-fda-510k.jpg K162267 - Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System K162267 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Sep 2016. https://www.510kdatabase.net/k160593/ 2016-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k160593-indy-otw-vascular-retriever-fda-510k.jpg K160593 - Indy OTW Vascular Retriever K160593 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Sep 2016. https://www.510kdatabase.net/k160606/ 2016-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k160606-bc-5d-hematology-control-fda-510k.jpg K160606 - BC-5D Hematology Control K160606 is a FDA 510(k) cleared hematology medical device. Manufacturer: R&D Systems, Inc.. Cleared Sep 2016. https://www.510kdatabase.net/k161392/ 2016-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k161392-elation-pulmonary-balloon-dilation-fda-510k.jpg K161392 - Elation Pulmonary Balloon Dilation K161392 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Sep 2016. https://www.510kdatabase.net/k161567/ 2016-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k161567-signa-voyager-fda-510k.jpg K161567 - SIGNA Voyager K161567 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Sep 2016. https://www.510kdatabase.net/k153649/ 2016-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k153649-exactech-novation-element-press-fit-fda-510k.jpg K153649 - Exactech® Novation® Element Press-fit Femoral Stem K153649 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Aug 2016. https://www.510kdatabase.net/k162129/ 2016-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k162129-renasys-g-gauze-dressing-kits-with-fda-510k.jpg K162129 - RENASYS-G Gauze Dressing Kits with Soft Port K162129 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Aug 2016. https://www.510kdatabase.net/k160597/ 2016-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k160597-independence-mis-spacers-fda-510k.jpg K160597 - INDEPENDENCE MIS Spacers K160597 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Aug 2016. https://www.510kdatabase.net/k161108/ 2016-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k161108-arthrex-vaultlock-glenoid-fda-510k.jpg K161108 - Arthrex VaultLock Glenoid K161108 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Aug 2016. https://www.510kdatabase.net/k160983/ 2016-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k160983-kyphon-hv-r-bone-cement-fda-510k.jpg K160983 - Kyphon HV-R Bone Cement K160983 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic, Inc.. Cleared Aug 2016. https://www.510kdatabase.net/k161196/ 2016-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k161196-somatom-drive-fda-510k.jpg K161196 - SOMATOM Drive K161196 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 2016. https://www.510kdatabase.net/k153347/ 2016-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k153347-codman-microsensor-basic-kit-codman-fda-510k.jpg K153347 - Codman Microsensor Basic Kit, Codman Microsensor Plastic Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit with Tuohy-Borst Adapter,Codman Microsensor Metal Skull Bolt Kit, Codman Microsensor Ventricular Catheter Kit K153347 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Aug 2016. https://www.510kdatabase.net/k161287/ 2016-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k161287-dxterity-dxterity-tra-dxterity-angio-fda-510k.jpg K161287 - DxTerity, DxTerity TRA, DxTerity Angio-Kit, DxTerity EZ-Pak, DxTerity TRA Angio-Kit, DxTerity TRA EZ-Pak K161287 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Aug 2016. https://www.510kdatabase.net/k153440/ 2016-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k153440-powerloc-max-power-injectable-infusion-fda-510k.jpg K153440 - PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set K153440 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Aug 2016. https://www.510kdatabase.net/k153651/ 2016-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k153651-access-tsh-3rd-is-assay-and-access-tsh-fda-510k.jpg K153651 - Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems K153651 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Aug 2016. https://www.510kdatabase.net/k153297/ 2016-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k153297-perifix-and-contiplex-catheter-fda-510k.jpg K153297 - Perifix and Contiplex Catheter K153297 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Aug 2016. https://www.510kdatabase.net/k153375/ 2016-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k153375-architect-25-oh-vitamin-d-5p02-fda-510k.jpg K153375 - ARCHITECT 25-OH Vitamin D 5P02, ARCHITECT 25-OH Vitamin D 5P02 Calibrators, ARCHITECT 25-OH Vitamin D 5P02 Controls K153375 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Aug 2016. https://www.510kdatabase.net/k161210/ 2016-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k161210-rialtotm-si-fusion-system-medtronic-fda-510k.jpg K161210 - RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) Systems K161210 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Aug 2016. https://www.510kdatabase.net/k160516/ 2016-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k160516-universal-cylinder-applicator-family-fda-510k.jpg K160516 - Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Set, odd lengths, Universal Cervix Probe Set, even lengths K160516 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Aug 2016. https://www.510kdatabase.net/k160743/ 2016-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k160743-philips-ingenuity-ct-fda-510k.jpg K160743 - Philips Ingenuity CT K160743 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Aug 2016. https://www.510kdatabase.net/k153276/ 2016-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k153276-da-vinci-xi-surgical-system-fda-510k.jpg K153276 - da Vinci Xi Surgical System K153276 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Aug 2016. https://www.510kdatabase.net/k161683/ 2016-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k161683-system-1e-liquid-chemical-sterilant-fda-510k.jpg K161683 - SYSTEM 1E Liquid Chemical Sterilant Processing System K161683 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Aug 2016. https://www.510kdatabase.net/k160219/ 2016-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k160219-hilal-embolization-microcoils-fda-510k.jpg K160219 - Hilal Embolization MicroCoils K160219 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Aug 2016. https://www.510kdatabase.net/k160542/ 2016-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k160542-50-fr-arndt-endobronchial-blocker-set-fda-510k.jpg K160542 - 5.0 Fr Arndt Endobronchial Blocker Set K160542 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Cook Incorporated. Cleared Aug 2016. https://www.510kdatabase.net/k160937/ 2016-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k160937-senolris-fda-510k.jpg K160937 - Senolris K160937 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Aug 2016. https://www.510kdatabase.net/k160107/ 2016-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k160107-diamondtouch-inflation-device-and-fda-510k.jpg K160107 - DiamondTOUCH Inflation Device and Fluid Dispensing Syringe K160107 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jul 2016. https://www.510kdatabase.net/k161801/ 2016-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k161801-crosscath-support-catheter-fda-510k.jpg K161801 - CrossCath Support Catheter K161801 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Jul 2016. https://www.510kdatabase.net/k160910/ 2016-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k160910-elecsys-syphilis-fda-510k.jpg K160910 - Elecsys Syphilis K160910 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Diagnostics. Cleared Jul 2016. https://www.510kdatabase.net/k161787/ 2016-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k161787-acuson-nx2-diagnostic-ultrasound-systems-fda-510k.jpg K161787 - ACUSON NX2 Diagnostic Ultrasound Systems K161787 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 2016. https://www.510kdatabase.net/k160887/ 2016-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k160887-cook-intraosseous-infusion-needles-fda-510k.jpg K160887 - Cook Intraosseous Infusion Needles K160887 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cook Incorporated. Cleared Jul 2016. https://www.510kdatabase.net/k152960/ 2016-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k152960-elan-4-motor-system-fda-510k.jpg K152960 - ELAN 4 Motor System K152960 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Jul 2016. https://www.510kdatabase.net/k160908/ 2016-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k160908-vis-u-all-low-temperature-fda-510k.jpg K160908 - Vis-U-All Low Temperature Sterilization Pouch/Tubing K160908 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Jul 2016. https://www.510kdatabase.net/k161218/ 2016-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k161218-gianturco-roehm-birds-nest-vena-cava-fda-510k.jpg K161218 - Gianturco-Roehm Bird’s Nest Vena Cava Filter K161218 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Jul 2016. https://www.510kdatabase.net/k161227/ 2016-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k161227-vitek-2-ast-gn-cefepime-012-32-ugml-fda-510k.jpg K161227 - VITEK 2 AST-GN Cefepime (<=0.12->=32 ug/mL) K161227 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jul 2016. https://www.510kdatabase.net/k161223/ 2016-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k161223-transcontinental-m-spacers-and-fda-510k.jpg K161223 - TransContinental® M Spacers and InterContinental® Plate-Spacers K161223 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Jul 2016. https://www.510kdatabase.net/k161525/ 2016-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k161525-te7-diagnostic-ultrasound-te5-fda-510k.jpg K161525 - TE7 Diagnostic Ultrasound, TE5 Diagnostic Ultrasound System K161525 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Jul 2016. https://www.510kdatabase.net/k161726/ 2016-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k161726-e-pack-procedure-kit-fda-510k.jpg K161726 - E-Pack Procedure Kit K161726 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Jul 2016. https://www.510kdatabase.net/k161271/ 2016-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k161271-da-vinci-xi-surgical-system-fda-510k.jpg K161271 - da Vinci Xi Surgical System K161271 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Jul 2016. https://www.510kdatabase.net/k153137/ 2016-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k153137-hemosil-hit-abpf4-h-hemosil-hit-abpf4-fda-510k.jpg K153137 - HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) Controls K153137 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jul 2016. https://www.510kdatabase.net/k152564/ 2016-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k152564-gemini-sterilization-wrap-fda-510k.jpg K152564 - Gemini Sterilization Wrap K152564 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Jul 2016. https://www.510kdatabase.net/k160433/ 2016-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k160433-v-pro-1-plus-and-v-pro-max-low-fda-510k.jpg K160433 - V-PRO® 1 Plus and V-PRO® maX Low Temperature K160433 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Jul 2016. https://www.510kdatabase.net/k151986/ 2016-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k151986-adva-centaur-testosterone-ii-tstii-fda-510k.jpg K151986 - ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material K151986 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Jun 2016. https://www.510kdatabase.net/k153273/ 2016-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k153273-myspine-pedicle-screw-placement-guides-fda-510k.jpg K153273 - MySpine Pedicle Screw Placement Guides - LP K153273 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Jun 2016. https://www.510kdatabase.net/k153393/ 2016-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k153393-powermidline-catheter-fda-510k.jpg K153393 - PowerMidline Catheter K153393 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jun 2016. https://www.510kdatabase.net/k160697/ 2016-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k160697-gibralt-spine-system-and-gibralt-fda-510k.jpg K160697 - Gibralt® Spine System and Gibralt® Occipital Spine System K160697 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Jun 2016. https://www.510kdatabase.net/k160911/ 2016-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k160911-vidas-brahms-pct-pct-fda-510k.jpg K160911 - VIDAS B.R.A.H.M.S. PCT (PCT) K160911 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jun 2016. https://www.510kdatabase.net/k161214/ 2016-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k161214-wondfo-amphetamine-urine-test-amp-500-fda-510k.jpg K161214 - Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC 150(Cup, Dipcard), Wondfo Methamphetamine Urine Test MET 500 (Cup, Dipcard) K161214 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.. Cleared Jun 2016. https://www.510kdatabase.net/k152122/ 2016-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k152122-instant-view-multi-drug-urine-test-cup-fda-510k.jpg K152122 - Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use) K152122 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Alfa Scientific Designs, Inc.. Cleared Jun 2016. https://www.510kdatabase.net/k160891/ 2016-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k160891-ultrathane-endoureterotomy-stent-set-fda-510k.jpg K160891 - Ultrathane Endoureterotomy Stent Set K160891 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Jun 2016. https://www.510kdatabase.net/k160823/ 2016-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k160823-nc-quantum-apex-ptca-dilatation-catheter-fda-510k.jpg K160823 - NC Quantum Apex PTCA Dilatation Catheter K160823 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Jun 2016. https://www.510kdatabase.net/k160514/ 2016-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k160514-opticross-18-30-mhz-peripheral-imaging-fda-510k.jpg K160514 - OptiCross 18, 30 MHz Peripheral Imaging Catheter K160514 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Jun 2016. https://www.510kdatabase.net/k161003/ 2016-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k161003-endovive-one-step-button-low-profile-fda-510k.jpg K161003 - EndoVive One Step Button Low Profile Initial Placement PEG Kit with ENFit Connector, EndoVive Low Profile Button Replacement Gastrostomy Tube Kit with ENFit Connector, EndoVive Button Right Angle Feeding Set with ENFit Connector, EndoVive Button Bolus Feeding Set with ENFit Connector, EndoVive Button Decompression Tube with ENFit Connector K161003 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Jun 2016. https://www.510kdatabase.net/k160071/ 2016-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k160071-stageone-disposable-cement-spacer-fda-510k.jpg K160071 - StageOne Disposable Cement Spacer Molds for Temporary Hemi-Shoulder Prosthesis K160071 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jun 2016. https://www.510kdatabase.net/k160645/ 2016-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k160645-presep-oligon-oximetry-catheter-fda-510k.jpg K160645 - PreSep Oligon Oximetry Catheter K160645 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Jun 2016. https://www.510kdatabase.net/k153607/ 2016-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k153607-roma-calculation-tool-using-elecsys-fda-510k.jpg K153607 - ROMA Calculation Tool Using Elecsys Assays K153607 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics. Cleared Jun 2016. https://www.510kdatabase.net/k153730/ 2016-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k153730-architect-syphilis-tp-reagent-fda-510k.jpg K153730 - ARCHITECT Syphilis TP Reagent, ARCHITECT Syphilis TP Calibrator, ARCHITECT Syphilis TP Control K153730 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Jun 2016. https://www.510kdatabase.net/k160738/ 2016-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k160738-zuk-select-knee-system-fda-510k.jpg K160738 - ZUK Select Knee System K160738 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jun 2016. https://www.510kdatabase.net/k151985/ 2016-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k151985-powerpicc-etoh-catheter-and-powerpicc-fda-510k.jpg K151985 - PowerPICC® EtOH Catheter and PowerPICC SOLO®2 EtOH Catheter K151985 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jun 2016. https://www.510kdatabase.net/k160729/ 2016-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k160729-elecys-brahms-pct-elecys-brahms-pct-fda-510k.jpg K160729 - Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5 K160729 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Diagnostics. Cleared Jun 2016. https://www.510kdatabase.net/k161035/ 2016-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k161035-medline-singe-patient-use-blood-fda-510k.jpg K161035 - Medline Singe Patient Use Blood Pressure Cuff K161035 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medline Industries, Inc.. Cleared Jun 2016. https://www.510kdatabase.net/k160370/ 2016-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k160370-bs-800m-abs800ba-800m-ise-kit-bs-800m-fda-510k.jpg K160370 - BS-800M/ ABS800/BA-800M ISE KIT, BS-800M Chemistry Analyzer, BA-800M Chemistry Analyzer, ABS800 Chemistry Analyzer K160370 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Jun 2016. https://www.510kdatabase.net/k160546/ 2016-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k160546-3m-attest-rapid-readout-biological-fda-510k.jpg K160546 - 3M Attest Rapid Readout Biological Indicator K160546 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Jun 2016. https://www.510kdatabase.net/k161183/ 2016-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k161183-halo-one-thin-walled-guiding-sheath-fda-510k.jpg K161183 - Halo One Thin-Walled Guiding Sheath K161183 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jun 2016. https://www.510kdatabase.net/k153280/ 2016-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k153280-powerglide-pro-midline-catheter-fda-510k.jpg K153280 - PowerGlide Pro Midline Catheter K153280 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jun 2016. https://www.510kdatabase.net/k152458/ 2016-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k152458-gemini-bonded-sterilization-wrap-fda-510k.jpg K152458 - Gemini Bonded Sterilization Wrap K152458 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Jun 2016. https://www.510kdatabase.net/k152635/ 2016-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k152635-quanta-flash-scl-70-quanta-flash-scl-fda-510k.jpg K152635 - QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls K152635 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Jun 2016. https://www.510kdatabase.net/k160485/ 2016-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k160485-verify-vh2o2-indicator-tape-fda-510k.jpg K160485 - VERIFY VH2O2 Indicator Tape K160485 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Jun 2016. https://www.510kdatabase.net/k160552/ 2016-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k160552-ev1000-clinical-platform-with-fda-510k.jpg K160552 - EV1000 Clinical Platform with ClearSight Finger Cuff or ClearSight System, EV1000 Clinical Platform K160552 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Jun 2016. https://www.510kdatabase.net/k152583/ 2016-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k152583-karl-storz-endoscopic-icg-imaging-system-fda-510k.jpg K152583 - KARL STORZ Endoscopic ICG Imaging System K152583 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared May 2016. https://www.510kdatabase.net/k160647/ 2016-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k160647-immulite-2000-third-generation-tsh-fda-510k.jpg K160647 - IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4 K160647 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared May 2016. https://www.510kdatabase.net/k160900/ 2016-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k160900-capsure-fixation-system-straight-5mm-x-fda-510k.jpg K160900 - CapSure Fixation System - Straight 5mm x 37 cm – 30 Permanent fasteners, CapSure Fixation System - Straight 5mm x 37 cm – 15 Permanent fasteners K160900 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 2016. https://www.510kdatabase.net/k160393/ 2016-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k160393-adtec-fda-510k.jpg K160393 - AdTec K160393 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared May 2016. https://www.510kdatabase.net/k160809/ 2016-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k160809-reveal-linq-fda-510k.jpg K160809 - Reveal LINQ K160809 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared May 2016. https://www.510kdatabase.net/k161190/ 2016-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k161190-g7-dual-mobility-system-active-fda-510k.jpg K161190 - G7 Dual Mobility System, Active Articulation System K161190 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared May 2016. https://www.510kdatabase.net/k153597/ 2016-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k153597-healgen-multi-drug-urine-test-cup-fda-510k.jpg K153597 - Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip Card K153597 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Healgen Scientific, LLC. Cleared May 2016. https://www.510kdatabase.net/k153359/ 2016-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k153359-bardport-slimport-and-x-port-implanted-fda-510k.jpg K153359 - BardPort®, SlimPort®, and X-Port® Implanted Ports K153359 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 2016. https://www.510kdatabase.net/k160091/ 2016-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k160091-temperature-probe-affinity-temperature-fda-510k.jpg K160091 - Temperature Probe, Affinity Temperature Probe K160091 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medtronic, Inc.. Cleared May 2016. https://www.510kdatabase.net/k152842/ 2016-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k152842-wallstent-rp-endoprosthesis-fda-510k.jpg K152842 - WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIAL K152842 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Boston Scientific Corporation. Cleared May 2016. https://www.510kdatabase.net/k153778/ 2016-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k153778-nester-embolization-coils-tornado-fda-510k.jpg K153778 - Nester Embolization Coils, Tornado Embolization Coils K153778 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared May 2016. https://www.510kdatabase.net/k161125/ 2016-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k161125-opticross-x-40-mhz-coronary-imaging-fda-510k.jpg K161125 - OptiCross X, 40 MHz Coronary Imaging Catheter K161125 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared May 2016. https://www.510kdatabase.net/k152062/ 2016-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k152062-biofoam-bone-wedge-fda-510k.jpg K152062 - BIOFOAM Bone Wedge K152062 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared May 2016. https://www.510kdatabase.net/k153236/ 2016-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k153236-small-perfix-light-plug-with-6-x-135-fda-510k.jpg K153236 - Small PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Medium PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay, Extra Large PerFix Light Plug with 6 x 13.5 cm HydroLight onlay K153236 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 2016. https://www.510kdatabase.net/k152630/ 2016-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k152630-verify-steam-integrating-indicator-fda-510k.jpg K152630 - VERIFY STEAM Integrating Indicator K152630 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared May 2016. https://www.510kdatabase.net/k160254/ 2016-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k160254-gore-dryseal-flex-introducer-sheath-fda-510k.jpg K160254 - GORE DrySeal Flex Introducer Sheath K160254 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared May 2016. https://www.510kdatabase.net/k153657/ 2016-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k153657-vanguard-xp-knee-system-fda-510k.jpg K153657 - Vanguard XP Knee System K153657 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared May 2016. https://www.510kdatabase.net/k160319/ 2016-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k160319-fibertak-dr-fda-510k.jpg K160319 - FiberTak DR K160319 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared May 2016. https://www.510kdatabase.net/k153008/ 2016-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k153008-invision-total-ankle-revision-system-fda-510k.jpg K153008 - INVISION Total Ankle Revision System K153008 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared May 2016. https://www.510kdatabase.net/k153139/ 2016-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k153139-achieve-st-mapping-catheter-catheter-fda-510k.jpg K153139 - Achieve ST Mapping Catheter, Catheter Connecting Cable K153139 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared May 2016. https://www.510kdatabase.net/k161047/ 2016-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k161047-logiq-p9-and-logiq-p7-fda-510k.jpg K161047 - LOGIQ P9 and LOGIQ P7 K161047 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared May 2016. https://www.510kdatabase.net/k160084/ 2016-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k160084-swan-ganz-catheters-fda-510k.jpg K160084 - Swan Ganz Catheters K160084 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared May 2016. https://www.510kdatabase.net/k160845/ 2016-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k160845-acquire-endoscopic-ultrasound-fine-fda-510k.jpg K160845 - Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device K160845 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared May 2016. https://www.510kdatabase.net/k160866/ 2016-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k160866-denali-filter-system-femoral-delivery-fda-510k.jpg K160866 - Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavian Delivery Kit K160866 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 2016. https://www.510kdatabase.net/k150598/ 2016-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k150598-blockade-surgical-gown-fda-510k.jpg K150598 - Blockade Surgical Gown K150598 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Apr 2016. https://www.510kdatabase.net/k152227/ 2016-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k152227-elecsys-cortisol-ii-cortisol-ii-calset-fda-510k.jpg K152227 - Elecsys Cortisol II, Cortisol II CalSet K152227 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Apr 2016. https://www.510kdatabase.net/k160202/ 2016-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k160202-trinidad-ch-vancomycin-vanc-trinidad-fda-510k.jpg K160202 - Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL) K160202 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Apr 2016. https://www.510kdatabase.net/k160162/ 2016-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k160162-voluson-p6-voluson-p8-fda-510k.jpg K160162 - Voluson P6, Voluson P8 K160162 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Apr 2016. https://www.510kdatabase.net/k160689/ 2016-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k160689-reveal-linq-fda-510k.jpg K160689 - Reveal LINQ K160689 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Apr 2016. https://www.510kdatabase.net/k151527/ 2016-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k151527-arthrex-univers-revers-ca-heads-and-fda-510k.jpg K151527 - Arthrex Univers Revers CA Heads and Adapters K151527 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Apr 2016. https://www.510kdatabase.net/k151120/ 2016-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k151120-simple-t-pediatric-nasal-mask-fda-510k.jpg K151120 - Simple T Pediatric Nasal Mask K151120 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Apr 2016. https://www.510kdatabase.net/k152075/ 2016-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k152075-vitek-2-ast-gram-negative-ertapenem-fda-510k.jpg K152075 - VITEK 2 AST-Gram Negative Ertapenem (<=0.12 - >=8 ug/mL) K152075 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Apr 2016. https://www.510kdatabase.net/k143578/ 2016-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k143578-sustain-r-tps-spacers-patriot-tps-fda-510k.jpg K143578 - SUSTAIN R TPS Spacers, PATRIOT TPS Spacers, CALIBER TPS Spacer, COALITION TPS Spacers, INDEPENDENCE TPS Spacer, FORTIFY -R TPS Corpectomy Spacer, FORTIFY I-R TPS Corpectomy Spacer, XPand -R TPS Corpectomy Spacer, NIKO TPS Corpectomy Spacer K143578 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Apr 2016. https://www.510kdatabase.net/k153038/ 2016-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k153038-everest-20-disposable-inflation-device-fda-510k.jpg K153038 - Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival Kit K153038 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Apr 2016. https://www.510kdatabase.net/k153653/ 2016-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k153653-dicom-viewer-fda-510k.jpg K153653 - DICOM Viewer K153653 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab AG. Cleared Apr 2016. https://www.510kdatabase.net/k160021/ 2016-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k160021-varian-sterilization-boxes-fda-510k.jpg K160021 - Varian Sterilization Boxes K160021 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Apr 2016. https://www.510kdatabase.net/k160461/ 2016-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k160461-arthrex-ibalance-bicompartmental-fda-510k.jpg K160461 - Arthrex iBalance BiCompartmental Arthroplasty System K160461 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Apr 2016. https://www.510kdatabase.net/k152013/ 2016-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k152013-quanta-flash-dsdna-quanta-flash-dsdna-fda-510k.jpg K152013 - QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls K152013 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Apr 2016. https://www.510kdatabase.net/k153301/ 2016-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k153301-elecsys-digoxin-immunoassay-elecsys-fda-510k.jpg K153301 - Elecsys Digoxin Immunoassay, Elecsys PreciControl Cardiac II K153301 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Apr 2016. https://www.510kdatabase.net/k153444/ 2016-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k153444-philips-multislice-ct-system-with-low-fda-510k.jpg K153444 - Philips Multislice CT System with Low Dose CT Lung Cancer K153444 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Apr 2016. https://www.510kdatabase.net/k160223/ 2016-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k160223-ventriclear-ventricular-drainage-fda-510k.jpg K160223 - VentriClear Ventricular Drainage Catheter Set with Cook Spectrum Antibiotic Impregnation, VentriClear II Ventricular Drainage Catheter K160223 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cook Incorporated. Cleared Apr 2016. https://www.510kdatabase.net/k153293/ 2016-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k153293-extension-set-fda-510k.jpg K153293 - Extension Set K153293 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Apr 2016. https://www.510kdatabase.net/k151967/ 2016-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k151967-centros-long-term-hemodialysis-fda-510k.jpg K151967 - Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis Catheter K151967 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Apr 2016. https://www.510kdatabase.net/k152428/ 2016-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k152428-sensicare-pi-surgical-gloves-fda-510k.jpg K152428 - SensiCare PI Surgical Gloves K152428 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Mar 2016. https://www.510kdatabase.net/k153447/ 2016-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k153447-magnetom-spectra-fda-510k.jpg K153447 - MAGNETOM Spectra K153447 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2016. https://www.510kdatabase.net/k160861/ 2016-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k160861-proxis-ureteral-access-sheath-fda-510k.jpg K160861 - Proxis Ureteral Access Sheath K160861 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 2016. https://www.510kdatabase.net/k152578/ 2016-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k152578-da-vinci-surgical-system-model-is4000-fda-510k.jpg K152578 - da Vinci Surgical System, Model IS4000 K152578 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Mar 2016. https://www.510kdatabase.net/k153160/ 2016-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k153160-avivo-mobile-patient-management-mpm-fda-510k.jpg K153160 - AVIVO Mobile Patient Management (MPM) System K153160 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Mar 2016. https://www.510kdatabase.net/k160637/ 2016-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k160637-rotatable-snares-fda-510k.jpg K160637 - Rotatable Snares K160637 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Mar 2016. https://www.510kdatabase.net/k160621/ 2016-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k160621-signapioneer-fda-510k.jpg K160621 - SIGNAPioneer K160621 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Mar 2016. https://www.510kdatabase.net/k160528/ 2016-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k160528-anatomic-peek-ptc-cervical-fusion-system-fda-510k.jpg K160528 - ANATOMIC PEEK PTC Cervical Fusion System K160528 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Mar 2016. https://www.510kdatabase.net/k151765/ 2016-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k151765-somatom-perspective-fda-510k.jpg K151765 - SOMATOM Perspective K151765 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2016. https://www.510kdatabase.net/k151923/ 2016-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k151923-vitek-2-ast-yeast-micafungin-006-8-mcgml-fda-510k.jpg K151923 - VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL) K151923 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Mar 2016. https://www.510kdatabase.net/k153337/ 2016-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k153337-corvocet-biopsy-system-fda-510k.jpg K153337 - Corvocet Biopsy System K153337 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Mar 2016. https://www.510kdatabase.net/k153595/ 2016-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k153595-optetrak-logic-metaphyseal-cones-fda-510k.jpg K153595 - Optetrak Logic Metaphyseal Cones K153595 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Mar 2016. https://www.510kdatabase.net/k151342/ 2016-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k151342-arthrex-swivelock-anchors-fda-510k.jpg K151342 - Arthrex SwiveLock Anchors K151342 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Mar 2016. https://www.510kdatabase.net/k151754/ 2016-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k151754-glide-on-vinyl-examination-gloves-fda-510k.jpg K151754 - Glide-On Vinyl Examination Gloves K151754 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Mar 2016. https://www.510kdatabase.net/k151749/ 2016-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k151749-somatom-scopewith-syngo-ct-vc30-easyiq-fda-510k.jpg K151749 - somatom Scope(with syngo CT VC30-easyIQ version), SOMATOM Scope Power(with syngo CT VC30-easyIQ version) K151749 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2016. https://www.510kdatabase.net/k151845/ 2016-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k151845-infant-heel-warmer-model-24401-and-fda-510k.jpg K151845 - Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) K151845 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: CooperSurgical, Inc.. Cleared Mar 2016. https://www.510kdatabase.net/k153693/ 2016-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k153693-immunalysis-methamphetamine-urine-fda-510k.jpg K153693 - Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators K153693 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Immunalysis Corporation. Cleared Mar 2016. https://www.510kdatabase.net/k160484/ 2016-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k160484-optetrak-advanced-patella-fda-510k.jpg K160484 - Optetrak Advanced Patella K160484 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Mar 2016. https://www.510kdatabase.net/k151665/ 2016-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k151665-sustain-additional-implants-fda-510k.jpg K151665 - SUSTAIN Additional Implants K151665 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Mar 2016. https://www.510kdatabase.net/k153355/ 2016-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k153355-xeleris-40-processing-and-review-fda-510k.jpg K153355 - Xeleris 4.0 Processing and Review Workstation K153355 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Mar 2016. https://www.510kdatabase.net/k160445/ 2016-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k160445-hemosil-silica-clotting-time-fda-510k.jpg K160445 - HemosIL Silica Clotting Time K160445 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Mar 2016. https://www.510kdatabase.net/k151688/ 2016-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k151688-chromid-mrsa-fda-510k.jpg K151688 - chromID MRSA K151688 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Mar 2016. https://www.510kdatabase.net/k152217/ 2016-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k152217-exactech-vantage-total-ankle-system-fda-510k.jpg K152217 - Exactech Vantage Total Ankle System K152217 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Mar 2016. https://www.510kdatabase.net/k153776/ 2016-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k153776-optetrak-one-logic-femoral-components-fda-510k.jpg K153776 - Optetrak One Logic Femoral Components K153776 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Mar 2016. https://www.510kdatabase.net/k152448/ 2016-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k152448-da-vinci-single-site-instrument-and-fda-510k.jpg K152448 - da Vinci Single-Site Instrument and Accessories K152448 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Mar 2016. https://www.510kdatabase.net/k160058/ 2016-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k160058-biomet-variable-pitch-compression-fda-510k.jpg K160058 - Biomet Variable Pitch Compression Screw System K160058 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Mar 2016. https://www.510kdatabase.net/k160381/ 2016-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k160381-te7-diagnostic-ultrasound-system-fda-510k.jpg K160381 - TE7 Diagnostic Ultrasound System K160381 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Mar 2016. https://www.510kdatabase.net/k150731/ 2016-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k150731-medline-epidural-catheter-fda-510k.jpg K150731 - Medline Epidural Catheter K150731 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Medline Industries, Inc.. Cleared Mar 2016. https://www.510kdatabase.net/k153244/ 2016-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k153244-cios-fusion-fda-510k.jpg K153244 - Cios Fusion K153244 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2016. https://www.510kdatabase.net/k153430/ 2016-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k153430-flexor-tuohy-borst-side-arm-fda-510k.jpg K153430 - Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select K153430 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Mar 2016. https://www.510kdatabase.net/k160418/ 2016-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k160418-perimeter-interbody-fusion-device-fda-510k.jpg K160418 - PERIMETER Interbody Fusion Device K160418 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Mar 2016. https://www.510kdatabase.net/k152421/ 2016-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k152421-is4000-stapler-30-instrument-and-fda-510k.jpg K152421 - IS4000 Stapler 30 Instrument and Stapler 30 Reloads K152421 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Mar 2016. https://www.510kdatabase.net/k153346/ 2016-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k153346-syngo-application-software-vd11-fda-510k.jpg K153346 - syngo Application Software VD11 K153346 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2016. https://www.510kdatabase.net/k160426/ 2016-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k160426-syngovia-mi-workflows-fda-510k.jpg K160426 - syngo.via MI Workflows K160426 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2016. https://www.510kdatabase.net/k152061/ 2016-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k152061-immulite-2000-tsi-assay-immulite-2000-fda-510k.jpg K152061 - IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material K152061 is a FDA 510(k) cleared immunology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Mar 2016. https://www.510kdatabase.net/k153448/ 2016-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k153448-passport-series-patient-monitors-fda-510k.jpg K153448 - Passport Series Patient Monitors (Including Passport 8, Passport 12) K153448 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Mar 2016. https://www.510kdatabase.net/k160276/ 2016-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k160276-acl-top-acl-top-700-acl-top-700-cts-fda-510k.jpg K160276 - ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS) K160276 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Mar 2016. https://www.510kdatabase.net/k153438/ 2016-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k153438-perimeter-c-titanium-spinal-system-fda-510k.jpg K153438 - PERIMETER C (Titanium) Spinal System K153438 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Mar 2016. https://www.510kdatabase.net/k160317/ 2016-02-29 monthly 0.5 https://www.510kdatabase.net/og-image/k160317-syngovia-mi-workflows-fda-510k.jpg K160317 - syngo.via MI Workflows K160317 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 2016. https://www.510kdatabase.net/k160173/ 2016-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k160173-ultra-ice-plus-9-mhz-intracardiac-echo-fda-510k.jpg K160173 - Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU) K160173 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Feb 2016. https://www.510kdatabase.net/k160182/ 2016-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k160182-logiq-s7-expert-fda-510k.jpg K160182 - LOGIQ S7 Expert K160182 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Feb 2016. https://www.510kdatabase.net/k153617/ 2016-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k153617-opticross-6-40-mhz-coronary-imaging-fda-510k.jpg K153617 - OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (EU Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (Intercontinental Distribution) K153617 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Feb 2016. https://www.510kdatabase.net/k160164/ 2016-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k160164-bd-veritor-system-for-rapid-detection-fda-510k.jpg K160164 - BD Veritor System for Rapid Detection of Flu A + B Labratory Kit K160164 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Feb 2016. https://www.510kdatabase.net/k160184/ 2016-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k160184-voluson-s6-voluson-s8-voluson-s10-fda-510k.jpg K160184 - Voluson S6, Voluson S8, Voluson S10 K160184 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Feb 2016. https://www.510kdatabase.net/k160161/ 2016-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k160161-bd-veritor-system-for-rapid-detection-fda-510k.jpg K160161 - BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit K160161 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Feb 2016. https://www.510kdatabase.net/k151092/ 2016-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k151092-arthrex-short-suture-anchors-fda-510k.jpg K151092 - Arthrex Short Suture Anchors K151092 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Feb 2016. https://www.510kdatabase.net/k151423/ 2016-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k151423-apex-compounding-system-transfer-set-fda-510k.jpg K151423 - APEX Compounding System Transfer Set K151423 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Feb 2016. https://www.510kdatabase.net/k153220/ 2016-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k153220-syngoct-single-source-dual-energy-twin-fda-510k.jpg K153220 - syngo.CT Single Source Dual Energy (Twin Beam) K153220 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 2016. https://www.510kdatabase.net/k153586/ 2016-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k153586-arthrex-ibalance-tka-system-fda-510k.jpg K153586 - Arthrex iBalance TKA System K153586 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Feb 2016. https://www.510kdatabase.net/k151817/ 2016-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k151817-vitek-2-ast-ys-caspofungin-0125-8-ugml-fda-510k.jpg K151817 - VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL K151817 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Feb 2016. https://www.510kdatabase.net/k152136/ 2016-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k152136-recovery-cone-removal-system-fda-510k.jpg K152136 - Recovery Cone Removal System K152136 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Feb 2016. https://www.510kdatabase.net/k152196/ 2016-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k152196-erchonia-evrl-fda-510k.jpg K152196 - Erchonia EVRL K152196 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Erchonia Corporation. Cleared Feb 2016. https://www.510kdatabase.net/k152902/ 2016-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k152902-passport-series-patient-monitors-fda-510k.jpg K152902 - Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) K152902 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Feb 2016. https://www.510kdatabase.net/k153442/ 2016-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k153442-cd-horizon-spinal-system-medtronic-fda-510k.jpg K153442 - CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with the STEALTHSTATION System, Medtronic Reusable Instruments for Use with the IPC POWEREASE System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION and IPC POWEREASE Systems K153442 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Feb 2016. https://www.510kdatabase.net/k151165/ 2016-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k151165-aesculap-dafilon-nonabsorbable-fda-510k.jpg K151165 - Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture K151165 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Feb 2016. https://www.510kdatabase.net/k151429/ 2016-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k151429-quanta-flash-jo-1-quanta-flash-jo-1-fda-510k.jpg K151429 - QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols K151429 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Feb 2016. https://www.510kdatabase.net/k152231/ 2016-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k152231-hornet-guidewire-hornet-10-guidewire-fda-510k.jpg K152231 - Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire K152231 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Feb 2016. https://www.510kdatabase.net/k153218/ 2016-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k153218-arthrex-synergy-uhd4-system-fda-510k.jpg K153218 - Arthrex Synergy UHD4 System K153218 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Arthrex, Inc.. Cleared Feb 2016. https://www.510kdatabase.net/k151529/ 2016-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k151529-dimension-vista-loci-total-fda-510k.jpg K151529 - Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator K151529 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Feb 2016. https://www.510kdatabase.net/k153232/ 2016-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k153232-cios-select-fda-510k.jpg K153232 - Cios Select K153232 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 2016. https://www.510kdatabase.net/k153589/ 2016-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k153589-cd-horizon-spinal-system-fda-510k.jpg K153589 - CD HORIZON Spinal System K153589 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Feb 2016. https://www.510kdatabase.net/k151772/ 2016-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k151772-actreen-mini-intermittent-urinary-fda-510k.jpg K151772 - Actreen Mini Intermittent Urinary Catheters K151772 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Feb 2016. https://www.510kdatabase.net/k152948/ 2016-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k152948-medline-anti-fog-solution-fda-510k.jpg K152948 - Medline Anti-Fog Solution K152948 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medline Industries, Inc.. Cleared Feb 2016. https://www.510kdatabase.net/k153203/ 2016-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k153203-navigation-instruments-fda-510k.jpg K153203 - Navigation Instruments K153203 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Feb 2016. https://www.510kdatabase.net/k160044/ 2016-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k160044-image1-spies-system-fda-510k.jpg K160044 - Image1 SPIES System K160044 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Feb 2016. https://www.510kdatabase.net/k143470/ 2016-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k143470-diazyme-fibrinogen-assay-diazyme-fda-510k.jpg K143470 - Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set K143470 is a FDA 510(k) cleared hematology medical device. Manufacturer: Diazyme Laboratories. Cleared Jan 2016. https://www.510kdatabase.net/k151939/ 2016-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k151939-coalition-spacers-fda-510k.jpg K151939 - COALITION Spacers K151939 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Jan 2016. https://www.510kdatabase.net/k151716/ 2016-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k151716-cable-ready-cable-grip-system-cable-fda-510k.jpg K151716 - Cable-Ready Cable Grip System: Cable-Ready Bone Plate System K151716 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jan 2016. https://www.510kdatabase.net/k153402/ 2016-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k153402-discovery-nmct-670-czt-fda-510k.jpg K153402 - Discovery NM/CT 670 CZT K153402 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Jan 2016. https://www.510kdatabase.net/k152241/ 2016-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k152241-medtronic-transportationsterilization-fda-510k.jpg K152241 - Medtronic Transportation/Sterilization Cassettes K152241 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Jan 2016. https://www.510kdatabase.net/k153672/ 2016-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k153672-basixtouch40-inflation-syringe-fda-510k.jpg K153672 - basixTOUCH40 Inflation Syringe K153672 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jan 2016. https://www.510kdatabase.net/k152613/ 2016-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k152613-true-flow-valvuloplasty-perfusion-fda-510k.jpg K152613 - True Flow Valvuloplasty Perfusion Catheter K152613 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 2016. https://www.510kdatabase.net/k152980/ 2016-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k152980-flo-trac-sensor-volume-view-sensor-fda-510k.jpg K152980 - Flo Trac sensor, Volume View sensor K152980 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Jan 2016. https://www.510kdatabase.net/k153373/ 2016-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k153373-cornerstone-psr-cervical-fusion-system-fda-510k.jpg K153373 - CORNERSTONE PSR Cervical Fusion System, PERIMETER C Spinal System, PEEK PREVAIL Cervical Interbody Device K153373 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Jan 2016. https://www.510kdatabase.net/k151794/ 2016-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k151794-da-vinci-xi-surgical-system-fda-510k.jpg K151794 - da Vinci Xi Surgical System K151794 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Jan 2016. https://www.510kdatabase.net/k151848/ 2016-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k151848-cable-ready-cable-grip-system-cable-fda-510k.jpg K151848 - Cable-Ready® Cable Grip System: Cable-Ready Pin System, Cable-Ready Needle System K151848 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jan 2016. https://www.510kdatabase.net/k153598/ 2016-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k153598-medtronic-bio-medicus-adult-cannula-kit-fda-510k.jpg K153598 - Medtronic Bio-Medicus Adult Cannula Kit K153598 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Jan 2016. https://www.510kdatabase.net/k153635/ 2016-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k153635-salvationr-external-fixation-system-fda-510k.jpg K153635 - SALVATION(R) External Fixation System K153635 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jan 2016. https://www.510kdatabase.net/k151282/ 2016-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k151282-core-nova-complete-operating-room-fda-510k.jpg K151282 - core nova Complete Operating Room Endoscopy K151282 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Jan 2016. https://www.510kdatabase.net/k151450/ 2016-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k151450-endoscope-sterilization-tray-fda-510k.jpg K151450 - Endoscope Sterilization Tray K151450 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Jan 2016. https://www.510kdatabase.net/k152880/ 2016-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k152880-biograph-horizon-petct-fda-510k.jpg K152880 - Biograph Horizon PET/CT K152880 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 2016. https://www.510kdatabase.net/k153147/ 2016-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k153147-cios-connect-fda-510k.jpg K153147 - Cios Connect K153147 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 2016. https://www.510kdatabase.net/k151051/ 2016-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k151051-universa-soft-ureteral-stents-and-fda-510k.jpg K151051 - Universa Soft Ureteral Stents and Stent Sets K151051 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Jan 2016. https://www.510kdatabase.net/k150969/ 2016-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k150969-unidrive-s-iii-ent-40701601-1-with-fda-510k.jpg K150969 - Unidrive S III ENT 40701601-1 with KARL STORZ-SCB, DrillCut-X II Shaver Handpiece, High Speed EC Micromotor II for use with INTRA Drill Handpieces K150969 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jan 2016. https://www.510kdatabase.net/k151018/ 2016-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k151018-embryo-biopsy-pipette-polar-body-fda-510k.jpg K151018 - Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette K151018 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Cook Incorporated. Cleared Jan 2016. https://www.510kdatabase.net/k152356/ 2016-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k152356-sapphire-fda-510k.jpg K152356 - Sapphire K152356 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Jan 2016. https://www.510kdatabase.net/k151771/ 2016-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k151771-immunalysis-benzodiazepines-urine-fda-510k.jpg K151771 - Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators K151771 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Immunalysis Corporation. Cleared Jan 2016. https://www.510kdatabase.net/k152536/ 2016-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k152536-myon-hc-manual-wheelchair-fda-510k.jpg K152536 - MyOn HC Manual Wheelchair K152536 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Invacare Corporation. Cleared Jan 2016. https://www.510kdatabase.net/k153190/ 2016-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k153190-zenysis-short-term-dialysis-catheter-fda-510k.jpg K153190 - Zenysis Short-Term Dialysis Catheter K153190 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 2016. https://www.510kdatabase.net/k153052/ 2016-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k153052-erchonia-pl-touch-fda-510k.jpg K153052 - Erchonia PL Touch K153052 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Erchonia Corporation. Cleared Jan 2016. https://www.510kdatabase.net/k151907/ 2015-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k151907-cable-ready-cable-grip-system-cable-fda-510k.jpg K151907 - Cable-Ready® Cable Grip System: Cable-Ready® GTR System, Cable-Ready® 1.8mm Cerclage Cables K151907 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Dec 2015. https://www.510kdatabase.net/k153463/ 2015-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k153463-cd-horizon-spinal-system-ipc-powerease-fda-510k.jpg K153463 - CD HORIZON Spinal System, IPC POWEREASE System K153463 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Dec 2015. https://www.510kdatabase.net/k152283/ 2015-12-24 monthly 0.5 https://www.510kdatabase.net/og-image/k152283-magnetom-amira-fda-510k.jpg K152283 - MAGNETOM Amira K152283 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Dec 2015. https://www.510kdatabase.net/k142826/ 2015-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k142826-advia-centaur-toxoplasma-m-toxo-m-fda-510k.jpg K142826 - ADVIA Centaur Toxoplasma M (Toxo M) K142826 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Dec 2015. https://www.510kdatabase.net/k152755/ 2015-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k152755-fastframe-external-fixation-system-fda-510k.jpg K152755 - FastFrame External Fixation System-Ankle Spanning K152755 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Dec 2015. https://www.510kdatabase.net/k152875/ 2015-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k152875-quanta-flash-b2gp1-domain1-quanta-fda-510k.jpg K152875 - QUANTA Flash B2GP1-Domain1, QUANTA Flash B2GP1-Domain1 Controls, HemosIL AcuStar Anti-B2GPI Domain 1, HemosIL AcuStar Anti-B2GPI Domain 1 Controls K152875 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Dec 2015. https://www.510kdatabase.net/k150748/ 2015-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k150748-flexipet-denuding-pipette-flexipet-fda-510k.jpg K150748 - Flexipet Denuding Pipette, Flexipet Manipulation Pipette K150748 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Cook Incorporated. Cleared Dec 2015. https://www.510kdatabase.net/k150931/ 2015-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k150931-mreye-embolization-coils-fda-510k.jpg K150931 - MReye Embolization Coils K150931 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Dec 2015. https://www.510kdatabase.net/k150964/ 2015-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k150964-mreye-flipper-detachable-embolization-fda-510k.jpg K150964 - MReye Flipper Detachable Embolization Coil and Delivery System K150964 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Dec 2015. https://www.510kdatabase.net/k153365/ 2015-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k153365-advia-chemistry-enzyme-1-calibrator-fda-510k.jpg K153365 - ADVIA Chemistry Enzyme 1 Calibrator, ADVIA Chemistry Enzyme 2 Calibrator K153365 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Dec 2015. https://www.510kdatabase.net/k151022/ 2015-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k151022-intraluminal-applicator-set-fda-510k.jpg K151022 - Intraluminal Applicator Set K151022 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Dec 2015. https://www.510kdatabase.net/k152155/ 2015-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k152155-architect-2nd-generation-testosterone-fda-510k.jpg K152155 - ARCHITECT 2nd Generation Testosterone K152155 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Dec 2015. https://www.510kdatabase.net/k152442/ 2015-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k152442-freestyle-freedom-blood-glucose-fda-510k.jpg K152442 - Freestyle Freedom Blood Glucose Monitoring Sytem K152442 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Dec 2015. https://www.510kdatabase.net/k151840/ 2015-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k151840-fighter-guidewire-marvel-guidewire-fda-510k.jpg K151840 - Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch Extension Wire K151840 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Dec 2015. https://www.510kdatabase.net/k152554/ 2015-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k152554-site-rite-8-ultrasound-system-site-fda-510k.jpg K152554 - Site-Rite 8 Ultrasound System, Site-Rite 8 Ultrasound System with Pinpoint GT Technology K152554 is a FDA 510(k) cleared radiology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 2015. https://www.510kdatabase.net/k150877/ 2015-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k150877-acl-top-family-50-series-acl-top-350-cts-fda-510k.jpg K150877 - ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS K150877 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Dec 2015. https://www.510kdatabase.net/k151767/ 2015-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k151767-trinidad-ch-system-td-lyte-integrated-fda-510k.jpg K151767 - Trinidad CH system, TD-LYTE Integrated Multisensor (Na, K, CI), TD-LYTE IMT Standard A, TD-LYTE IMT Standard B + Salt Bridge, Trinidad CH Albumin BCP reagent (Alb_P), Trinidad CH Albumin BCP Calibrator K151767 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Dec 2015. https://www.510kdatabase.net/k152609/ 2015-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k152609-gore-synecor-biomaterial-fda-510k.jpg K152609 - GORE SYNECOR Biomaterial K152609 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Dec 2015. https://www.510kdatabase.net/k152974/ 2015-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k152974-ortholoc-3di-foot-plating-fda-510k.jpg K152974 - ORTHOLOC® 3Di Foot Plating Reconstruction System K152974 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Dec 2015. https://www.510kdatabase.net/k153088/ 2015-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k153088-axios-stent-with-delivery-system-axios-fda-510k.jpg K153088 - AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery System K153088 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Dec 2015. https://www.510kdatabase.net/k153298/ 2015-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k153298-accucath-intravascular-catheter-fda-510k.jpg K153298 - AccuCath Intravascular Catheter K153298 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 2015. https://www.510kdatabase.net/k153126/ 2015-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k153126-da-vinci-xi-hasson-cone-fda-510k.jpg K153126 - da Vinci Xi Hasson Cone K153126 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Dec 2015. https://www.510kdatabase.net/k152783/ 2015-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k152783-merit-20-ml-syringe-fda-510k.jpg K152783 - Merit 20 mL Syringe K152783 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Dec 2015. https://www.510kdatabase.net/k152401/ 2015-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k152401-stingray-lp-catheter-fda-510k.jpg K152401 - Stingray LP Catheter K152401 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Dec 2015. https://www.510kdatabase.net/k152484/ 2015-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k152484-fastframe-external-fixation-system-fda-510k.jpg K152484 - FastFrame External Fixation System - Distal Radius K152484 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Dec 2015. https://www.510kdatabase.net/k150787/ 2015-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k150787-universal-spike-fda-510k.jpg K150787 - Universal Spike K150787 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Dec 2015. https://www.510kdatabase.net/k152566/ 2015-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k152566-peba-anchorsuture-combination-20mm-fda-510k.jpg K152566 - PEBA Anchor/Suture Combination, 2.0mm Mini-Tac Anchor, Model 10-1629-01, Modification to Twinfix Ti Quick-T, Twinfix FT PK, Twinfix Ultra Ti, Twinfix Ultra PK, Twinfix Ultra HA Suture Anchors, FOOTPRINT Ultra OK Suture Anchors, BIORAPTOR 2.9 Suture Anchor, BIORAPTOR 2.3 PK Suture Anchor, OSTEORAPTOR Suture Anchor, BIORAPTOR Knotless Suture Anchor, HEALICOIL PK Suture Anchor (formerly Next Generation Fully Threaded Suture Anchor), Bioraptor Curved 2.3 PK Suture Anchors K152566 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Dec 2015. https://www.510kdatabase.net/k150640/ 2015-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k150640-rx-fix-mini-rail-external-fixator-fda-510k.jpg K150640 - RX-FIX Mini Rail External Fixator K150640 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Dec 2015. https://www.510kdatabase.net/k152060/ 2015-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k152060-3m-attest-rapid-readout-biological-fda-510k.jpg K152060 - 3M Attest Rapid Readout Biological Indicator 1295 K152060 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Dec 2015. https://www.510kdatabase.net/k150238/ 2015-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k150238-sensicare-sterile-powder-free-polymer-fda-510k.jpg K150238 - SensiCare Sterile Powder-Free Polymer Coated Polyisoprene Surgical glove, With Aloe Vera (Tested of Use with Chemotherapy Drugs) -Natural Color K150238 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Nov 2015. https://www.510kdatabase.net/k151656/ 2015-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k151656-heartway-power-mobility-scooter-fda-510k.jpg K151656 - HEARTWAY Power Mobility Scooter K151656 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Heartway Medical Products Co., Ltd.. Cleared Nov 2015. https://www.510kdatabase.net/k152490/ 2015-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k152490-dermabond-prineo-skin-closure-system-fda-510k.jpg K152490 - DERMABOND PRINEO Skin Closure System K152490 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Nov 2015. https://www.510kdatabase.net/k152494/ 2015-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k152494-zimmer-nexgen-complete-knee-solution-fda-510k.jpg K152494 - Zimmer NexGen Complete Knee Solution Tibial and Femoral Augments K152494 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Nov 2015. https://www.510kdatabase.net/k152761/ 2015-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k152761-permanent-beacon-transponder-soft-fda-510k.jpg K152761 - Permanent Beacon Transponder, Soft Tissue Beacon Transponder, Beacon Care Package - Soft Tissue (17G) K152761 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Nov 2015. https://www.510kdatabase.net/k142955/ 2015-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k142955-somatom-force-somatom-definition-flash-fda-510k.jpg K142955 - SOMATOM Force, SOMATOM Definition Flash, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATON Emotion 6/16, SOMATOM Sensation 64/Sensation Cardiac , SOMATOM Perspective SOMATOM Scope/ Scope Power K142955 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2015. https://www.510kdatabase.net/k152841/ 2015-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k152841-zimmer-plates-and-screws-system-zps-fda-510k.jpg K152841 - Zimmer Plates and Screws System (ZPS) Sterile 2.7mm Cortical Screws K152841 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Nov 2015. https://www.510kdatabase.net/k153150/ 2015-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k153150-autoloader-and-nova-view-with-models-fda-510k.jpg K153150 - AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000 K153150 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Nov 2015. https://www.510kdatabase.net/k152495/ 2015-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k152495-wondfo-propoxyphene-urine-test-fda-510k.jpg K152495 - Wondfo Propoxyphene Urine Test K152495 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.. Cleared Nov 2015. https://www.510kdatabase.net/k152762/ 2015-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k152762-fogarty-occlusion-catheter-fda-510k.jpg K152762 - Fogarty Occlusion Catheter K152762 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Nov 2015. https://www.510kdatabase.net/k153115/ 2015-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k153115-arthrex-univers-apex-size-5-stem-fda-510k.jpg K153115 - Arthrex Univers Apex, Size 5 Stem K153115 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Nov 2015. https://www.510kdatabase.net/k150514/ 2015-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k150514-power-injectable-implantable-ports-fda-510k.jpg K150514 - Power-Injectable Implantable Ports with ChronoFlex Polyurethane Catheters K150514 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 2015. https://www.510kdatabase.net/k150525/ 2015-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k150525-spies-3d-tip-cam-image-1-spies-ccu-fda-510k.jpg K150525 - SPIES 3D Tip Cam, Image 1 SPIES CCU Image Connect, Image 1 SPIES CCU D-3 Link K150525 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Nov 2015. https://www.510kdatabase.net/k150698/ 2015-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k150698-gemini-sterilization-wrap-fda-510k.jpg K150698 - Gemini Sterilization Wrap K150698 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Nov 2015. https://www.510kdatabase.net/k151792/ 2015-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k151792-trinidad-im-thyroid-stimulating-fda-510k.jpg K151792 - Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) System K151792 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Nov 2015. https://www.510kdatabase.net/k152853/ 2015-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k152853-wallstent-rp-endoprosthesis-fda-510k.jpg K152853 - WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic Biliary K152853 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Nov 2015. https://www.510kdatabase.net/k150790/ 2015-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k150790-redapt-porous-acetabular-shell-and-fda-510k.jpg K150790 - REDAPT Porous Acetabular Shell and Cemented Liner K150790 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Nov 2015. https://www.510kdatabase.net/k152252/ 2015-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k152252-arthrex-ibalance-tka-system-fda-510k.jpg K152252 - Arthrex iBalance TKA System K152252 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Nov 2015. https://www.510kdatabase.net/k150353/ 2015-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k150353-btl-4000-fda-510k.jpg K150353 - BTL-4000 K150353 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: BTL Industries, Inc.. Cleared Nov 2015. https://www.510kdatabase.net/k150436/ 2015-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k150436-comborehab-fda-510k.jpg K150436 - ComboRehab K150436 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Shenzhen Dongdixin Technology Co., Ltd.. Cleared Nov 2015. https://www.510kdatabase.net/k152277/ 2015-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k152277-pivoxtm-oblique-lateral-spinal-system-fda-510k.jpg K152277 - PIVOX(tm) Oblique Lateral Spinal System K152277 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Nov 2015. https://www.510kdatabase.net/k152928/ 2015-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k152928-multitom-rax-fda-510k.jpg K152928 - Multitom Rax K152928 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2015. https://www.510kdatabase.net/k153049/ 2015-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k153049-lithovue-system-fda-510k.jpg K153049 - LithoVue System K153049 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Nov 2015. https://www.510kdatabase.net/k150800/ 2015-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k150800-valved-safety-centesis-catheter-fda-510k.jpg K150800 - Valved Safety Centesis Catheter K150800 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Nov 2015. https://www.510kdatabase.net/k151752/ 2015-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k151752-somatom-emotion-616-fda-510k.jpg K151752 - SOMATOM Emotion 6/16 K151752 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2015. https://www.510kdatabase.net/k152382/ 2015-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k152382-arthrex-ibalance-tka-system-fda-510k.jpg K152382 - Arthrex iBalance TKA System K152382 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Nov 2015. https://www.510kdatabase.net/k152623/ 2015-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k152623-atlantis-anterior-cervical-plate-system-fda-510k.jpg K152623 - ATLANTIS Anterior Cervical Plate System K152623 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Nov 2015. https://www.510kdatabase.net/k152976/ 2015-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k152976-vlp-mini-mod-talus-plates-fda-510k.jpg K152976 - VLP Mini-Mod Talus Plates K152976 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Nov 2015. https://www.510kdatabase.net/k151315/ 2015-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k151315-expect-pulmonary-endobronchial-fda-510k.jpg K151315 - Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle K151315 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Boston Scientific Corporation. Cleared Nov 2015. https://www.510kdatabase.net/k143693/ 2015-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k143693-medline-sharps-containers-fda-510k.jpg K143693 - MEDLINE SHARPS CONTAINERS K143693 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Nov 2015. https://www.510kdatabase.net/k151903/ 2015-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k151903-slendertone-connect-abs-fda-510k.jpg K151903 - Slendertone connect Abs K151903 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Bio-Medical Research, Ltd.. Cleared Nov 2015. https://www.510kdatabase.net/k151925/ 2015-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k151925-elation-wireguided-balloon-dilation-fda-510k.jpg K151925 - Elation Wireguided Balloon Dilation Catheter K151925 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Nov 2015. https://www.510kdatabase.net/k152567/ 2015-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k152567-voluson-e6-voluson-e8-voluson-e10-fda-510k.jpg K152567 - Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound System K152567 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Nov 2015. https://www.510kdatabase.net/k152248/ 2015-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k152248-cd-horizon-spinal-system-fda-510k.jpg K152248 - CD HORIZON Spinal System K152248 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Nov 2015. https://www.510kdatabase.net/k150168/ 2015-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k150168-dimension-tacrolimus-flex-reagent-fda-510k.jpg K150168 - Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL) K150168 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Siemens Healthcare Diagnostics. Cleared Nov 2015. https://www.510kdatabase.net/k150713/ 2015-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k150713-syngoct-myocardial-perfusion-fda-510k.jpg K150713 - syngo.CT Myocardial Perfusion K150713 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2015. https://www.510kdatabase.net/k151992/ 2015-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k151992-fastframe-external-fixation-system-fda-510k.jpg K151992 - FastFrame External Fixation System - Knee Spanning, FastFrame External Fixation System - Damage Control K151992 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Nov 2015. https://www.510kdatabase.net/k152381/ 2015-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k152381-prelude-snap-splittable-hydrophilic-fda-510k.jpg K152381 - Prelude SNAP Splittable Hydrophilic Sheath Introducer K152381 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Oct 2015. https://www.510kdatabase.net/k152481/ 2015-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k152481-duraform-dural-graft-implant-fda-510k.jpg K152481 - DURAFORM Dural Graft Implant K152481 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Oct 2015. https://www.510kdatabase.net/k152543/ 2015-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k152543-m9m9cvm9t-diagnostic-ultrasound-system-fda-510k.jpg K152543 - M9/M9CV/M9T Diagnostic Ultrasound System K152543 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Oct 2015. https://www.510kdatabase.net/k152605/ 2015-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k152605-impulse-angiographic-catheter-expo-fda-510k.jpg K152605 - Impulse Angiographic Catheter, Expo Angiographic Catheter K152605 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Oct 2015. https://www.510kdatabase.net/k152315/ 2015-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k152315-journey-ii-uni-tibial-base-and-insert-fda-510k.jpg K152315 - JOURNEY II Uni Tibial Base and Insert K152315 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 2015. https://www.510kdatabase.net/k152338/ 2015-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k152338-vertexr-reconstruction-system-fda-510k.jpg K152338 - VERTEX(r) Reconstruction System K152338 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Oct 2015. https://www.510kdatabase.net/k150241/ 2015-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k150241-genesis-ii-xlpe-resurfacing-patellar-fda-510k.jpg K150241 - Genesis II XLPE Resurfacing Patellar Components K150241 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 2015. https://www.510kdatabase.net/k151865/ 2015-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k151865-premipatch-ptfe-pledget-fda-510k.jpg K151865 - PremiPatch PTFE Pledget K151865 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Aesculap, Inc.. Cleared Oct 2015. https://www.510kdatabase.net/k151954/ 2015-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k151954-a7-anesthesia-system-fda-510k.jpg K151954 - A7 Anesthesia System K151954 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Oct 2015. https://www.510kdatabase.net/k152457/ 2015-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k152457-cd-horizon-spinal-system-fda-510k.jpg K152457 - CD HORIZON Spinal System K152457 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Oct 2015. https://www.510kdatabase.net/k153003/ 2015-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k153003-signa-pioneer-fda-510k.jpg K153003 - SIGNA Pioneer K153003 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Oct 2015. https://www.510kdatabase.net/k151882/ 2015-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k151882-varian-treatment-vtx-fda-510k.jpg K151882 - Varian Treatment (VTx) K151882 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Oct 2015. https://www.510kdatabase.net/k150606/ 2015-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k150606-emit-ii-plus-buprenorphine-assay-emit-fda-510k.jpg K150606 - Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug Calibrator/Control Level 1, Level 2 Level 3, Level 4, Emit II Plus Specialty Drug Control Negative, Emit II Plus Specialty Drug Control Positive K150606 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Oct 2015. https://www.510kdatabase.net/k151895/ 2015-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k151895-expect-pulmonary-endobronchial-fda-510k.jpg K151895 - Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle K151895 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Oct 2015. https://www.510kdatabase.net/k152096/ 2015-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k152096-dermabond-advanced-topical-skin-fda-510k.jpg K152096 - DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin Adhesive K152096 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Oct 2015. https://www.510kdatabase.net/k152693/ 2015-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k152693-clearsign-ii-amplifier-40-channels-fda-510k.jpg K152693 - CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels, CLEARSIGN II Amplifier 120 Channels, CLEARSIGN II Amplifier 160 Channels K152693 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Oct 2015. https://www.510kdatabase.net/k152726/ 2015-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k152726-journey-ii-xr-knee-system-fda-510k.jpg K152726 - JOURNEY II XR Knee System K152726 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 2015. https://www.510kdatabase.net/k152763/ 2015-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k152763-resona-7resona-7cvresona-7expresona-fda-510k.jpg K152763 - Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System K152763 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Oct 2015. https://www.510kdatabase.net/k152663/ 2015-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k152663-bladeless-optical-obturators-fda-510k.jpg K152663 - Bladeless Optical Obturators K152663 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Oct 2015. https://www.510kdatabase.net/k152633/ 2015-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k152633-chandler-transluminal-bipolar-pacing-fda-510k.jpg K152633 - Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe K152633 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Oct 2015. https://www.510kdatabase.net/k152621/ 2015-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k152621-ossarcos-im-total-femur-rod-fda-510k.jpg K152621 - OSS/Arcos IM Total Femur Rod K152621 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Oct 2015. https://www.510kdatabase.net/k143577/ 2015-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k143577-xw-100-automated-hematology-analyzer-fda-510k.jpg K143577 - XW-100 Automated Hematology Analyzer, XW QC CHECK K143577 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sysmex America, Inc.. Cleared Oct 2015. https://www.510kdatabase.net/k151044/ 2015-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k151044-clickline-scissor-insert-for-single-use-fda-510k.jpg K151044 - CLICKLINE Scissor Insert for Single Use K151044 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Oct 2015. https://www.510kdatabase.net/k151242/ 2015-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k151242-sterilcontainer-s-fda-510k.jpg K151242 - SterilContainer S K151242 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Aesculap, Inc.. Cleared Oct 2015. https://www.510kdatabase.net/k152036/ 2015-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k152036-somatom-definition-edge-somatom-fda-510k.jpg K152036 - SOMATOM Definition Edge, SOMATOM Definition AS/AS+ K152036 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 2015. https://www.510kdatabase.net/k151603/ 2015-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k151603-arcos-one-piece-femoral-revision-system-fda-510k.jpg K151603 - Arcos One-piece Femoral Revision System K151603 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Oct 2015. https://www.510kdatabase.net/k151610/ 2015-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k151610-comet-pressure-guidewire-fda-510k.jpg K151610 - Comet Pressure Guidewire K151610 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Oct 2015. https://www.510kdatabase.net/k151613/ 2015-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k151613-ilab-polaris-multi-modality-guidance-fda-510k.jpg K151613 - iLab Polaris Multi-Modality Guidance System K151613 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Oct 2015. https://www.510kdatabase.net/k152572/ 2015-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k152572-axios-stent-and-delivery-system-fda-510k.jpg K152572 - AXIOS Stent and Delivery System K152572 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Oct 2015. https://www.510kdatabase.net/k152526/ 2015-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k152526-elecsys-progesterone-iii-calset-fda-510k.jpg K152526 - Elecsys Progesterone III CalSet K152526 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Oct 2015. https://www.510kdatabase.net/k152545/ 2015-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k152545-dc-60dc-60sdc-60-expdc-55-diagnostic-fda-510k.jpg K152545 - DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound Systems K152545 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Oct 2015. https://www.510kdatabase.net/k150694/ 2015-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k150694-3m-comply-hydrogen-peroxide-indicator-fda-510k.jpg K150694 - 3M Comply Hydrogen Peroxide Indicator Tape 1228 K150694 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Oct 2015. https://www.510kdatabase.net/k152524/ 2015-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k152524-entuit-secure-gastrointestinal-suture-fda-510k.jpg K152524 - Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable Gastrointestinal Suture Anchor Set K152524 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Sep 2015. https://www.510kdatabase.net/k150622/ 2015-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k150622-3m-comply-hydrogen-peroxide-chemical-fda-510k.jpg K150622 - 3M Comply Hydrogen Peroxide Chemical Indicator 1248 K150622 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Sep 2015. https://www.510kdatabase.net/k150998/ 2015-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k150998-heartway-power-mobility-scooter-fda-510k.jpg K150998 - HEARTWAY Power Mobility Scooter K150998 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Heartway Medical Products Co., Ltd.. Cleared Sep 2015. https://www.510kdatabase.net/k151579/ 2015-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k151579-magnetom-aera-24-channel-magnetom-fda-510k.jpg K151579 - MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fit K151579 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 2015. https://www.510kdatabase.net/k152195/ 2015-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k152195-logiq-s8-fda-510k.jpg K152195 - LOGIQ S8 K152195 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Sep 2015. https://www.510kdatabase.net/k150862/ 2015-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k150862-depuy-actis-duofox-hip-prosthesis-fda-510k.jpg K150862 - DePuy Actis Duofox Hip Prosthesis K150862 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Sep 2015. https://www.510kdatabase.net/k151786/ 2015-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k151786-elecsys-vitamin-b12-ii-assay-elecsys-fda-510k.jpg K151786 - Elecsys Vitamin B12 II assay, Elecsys Vitamin B12 II CalSet K151786 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Sep 2015. https://www.510kdatabase.net/k150987/ 2015-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k150987-heartway-power-mobility-scooter-brio-s19-fda-510k.jpg K150987 - HEARTWAY Power Mobility Scooter, BRIO S19 K150987 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Heartway Medical Products Co., Ltd.. Cleared Sep 2015. https://www.510kdatabase.net/k143754/ 2015-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k143754-quanta-flash-ccp3-quanta-flash-ccp3-fda-510k.jpg K143754 - QUANTA Flash CCP3, QUANTA Flash CCP3 Calibrators, and QUANTA Flash CCP3 K143754 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Sep 2015. https://www.510kdatabase.net/k151313/ 2015-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k151313-zelantedvt-thrombectomy-set-fda-510k.jpg K151313 - ZelanteDVT Thrombectomy Set K151313 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Sep 2015. https://www.510kdatabase.net/k143743/ 2015-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k143743-echo-20-lap-system-with-ventralight-st-fda-510k.jpg K143743 - ECHO 2.0 LAP SYSTEM with VENTRALIGHT ST MESH K143743 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Sep 2015. https://www.510kdatabase.net/k150638/ 2015-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k150638-af541-se-full-face-mask-fda-510k.jpg K150638 - AF541 SE Full Face Mask K150638 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Sep 2015. https://www.510kdatabase.net/k150639/ 2015-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k150639-af541-ee-full-face-mask-fda-510k.jpg K150639 - AF541 EE Full Face Mask K150639 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Sep 2015. https://www.510kdatabase.net/k151302/ 2015-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k151302-clinpro-varnish-fda-510k.jpg K151302 - Clinpro Varnish K151302 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Sep 2015. https://www.510kdatabase.net/k152335/ 2015-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k152335-export-advance-aspiration-catheter-fda-510k.jpg K152335 - Export Advance Aspiration Catheter K152335 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Sep 2015. https://www.510kdatabase.net/k152393/ 2015-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k152393-eclipse-treatment-planning-system-fda-510k.jpg K152393 - Eclipse Treatment Planning System K152393 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Sep 2015. https://www.510kdatabase.net/k143640/ 2015-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k143640-ksea-cmos-camera-system-c-cam-fda-510k.jpg K143640 - KSEA CMOS Camera System (C-cam) K143640 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Sep 2015. https://www.510kdatabase.net/k151887/ 2015-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k151887-syngo-vsim-fda-510k.jpg K151887 - syngo VSim K151887 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 2015. https://www.510kdatabase.net/k152346/ 2015-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k152346-microscan-dried-gram-positive-miccombo-fda-510k.jpg K152346 - MicroScan Dried Gram Positive MIC/Combo Panels - Vancomycin (0.25-64 ug/mL) K152346 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Sep 2015. https://www.510kdatabase.net/k151645/ 2015-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k151645-mammomat-fusion-fda-510k.jpg K151645 - MAMMOMAT Fusion K151645 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 2015. https://www.510kdatabase.net/k152018/ 2015-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k152018-varian-cleaning-caps-varian-leak-stop-fda-510k.jpg K152018 - Varian Cleaning Caps, Varian Leak Stop Buttons, Varian Leak Stop Channel Marker Sets K152018 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Sep 2015. https://www.510kdatabase.net/k152269/ 2015-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k152269-healgen-amphetamine-test-strip-fda-510k.jpg K152269 - Healgen Amphetamine Test (Strip, Cassette, Cup, Dip Card), Healgen Cocaine Test (Strip, Cassette, Cup, Dip Card), Healgen Methamphetamine Test (Strip, Cassette, Cup, Dip Card) K152269 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Healgen Scientific, LLC. Cleared Sep 2015. https://www.510kdatabase.net/k151442/ 2015-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k151442-total-compression-plating-tcp-system-fda-510k.jpg K151442 - TOTAL COMPRESSION PLATING (TCP) SYSTEM K151442 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Sep 2015. https://www.510kdatabase.net/k151838/ 2015-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k151838-pro-toe-hammertoe-fixation-system-fda-510k.jpg K151838 - PRO-TOE Hammertoe Fixation System K151838 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Sep 2015. https://www.510kdatabase.net/k152176/ 2015-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k152176-immunalysis-pcp-urine-enzyme-fda-510k.jpg K152176 - Immunalysis PCP Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators K152176 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Immunalysis Corporation. Cleared Sep 2015. https://www.510kdatabase.net/k141960/ 2015-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k141960-exactech-novation-crown-cup-fda-510k.jpg K141960 - Exactech® Novation® Crown Cup® K141960 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Sep 2015. https://www.510kdatabase.net/k151902/ 2015-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k151902-redapt-revision-femoral-system-fda-510k.jpg K151902 - REDAPT¿ Revision Femoral System K151902 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Sep 2015. https://www.510kdatabase.net/k152170/ 2015-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k152170-exactech-optetrak-logic-enhanced-fda-510k.jpg K152170 - Exactech Optetrak Logic Enhanced Assembly K152170 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Sep 2015. https://www.510kdatabase.net/k150082/ 2015-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k150082-panorama-patient-monitoring-network-fda-510k.jpg K150082 - Panorama Patient Monitoring Network K150082 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Sep 2015. https://www.510kdatabase.net/k150352/ 2015-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k150352-v-series-monitoring-system-including-fda-510k.jpg K150352 - V Series Monitoring System (including V12 and V21 Monitors) K150352 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Sep 2015. https://www.510kdatabase.net/k152143/ 2015-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k152143-truclear-operative-hysteroscope-5c-and-fda-510k.jpg K152143 - TRUCLEAR Operative Hysteroscope 5C and Sheath 5C K152143 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Sep 2015. https://www.510kdatabase.net/k151732/ 2015-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k151732-arthrex-fracture-plates-fda-510k.jpg K151732 - Arthrex Fracture Plates K151732 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Aug 2015. https://www.510kdatabase.net/k152116/ 2015-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k152116-55-f-worley-advanced-lvi-lateral-vein-fda-510k.jpg K152116 - 5.5 F Worley Advanced LVI Lateral Vein Introducer K152116 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Aug 2015. https://www.510kdatabase.net/k142976/ 2015-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k142976-ultratens-fda-510k.jpg K142976 - UltraTENS K142976 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Shenzhen Dongdixin Technology Co., Ltd.. Cleared Aug 2015. https://www.510kdatabase.net/k143529/ 2015-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k143529-ultrasmooth-lubricating-liquid-and-fda-510k.jpg K143529 - UltraSmooth Lubricating Liquid, and Medline Lubricating Liquid and Vaginal Moisturizer K143529 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Medline Industries, Inc.. Cleared Aug 2015. https://www.510kdatabase.net/k152045/ 2015-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k152045-salvation-external-fixation-system-fda-510k.jpg K152045 - SALVATION® External Fixation System K152045 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Aug 2015. https://www.510kdatabase.net/k150648/ 2015-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k150648-arthrex-dx-swivelock-sl-with-forket-fda-510k.jpg K150648 - Arthrex DX SwiveLock SL with Forket Eyelet 3.5 x 8.5mm, Arthrex DX SwiveLock Suture Anchor, 3.5 x 13.5mm K150648 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Aug 2015. https://www.510kdatabase.net/k143729/ 2015-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k143729-sterilcontainer-s-fda-510k.jpg K143729 - SterilContainer S K143729 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Aesculap, Inc.. Cleared Aug 2015. https://www.510kdatabase.net/k151348/ 2015-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k151348-healgen-propoxyphene-test-strip-fda-510k.jpg K151348 - Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card) K151348 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Healgen Scientific, LLC. Cleared Aug 2015. https://www.510kdatabase.net/k151172/ 2015-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k151172-mastergraft-contain-fda-510k.jpg K151172 - MASTERGRAFT Contain K151172 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Aug 2015. https://www.510kdatabase.net/k152044/ 2015-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k152044-flexor-radial-hydrophilic-introducer-fda-510k.jpg K152044 - Flexor Radial Hydrophilic Introducer Access Set K152044 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Aug 2015. https://www.510kdatabase.net/k151200/ 2015-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k151200-stratafix-spiral-monocryl-knotless-fda-510k.jpg K151200 - STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device K151200 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Aug 2015. https://www.510kdatabase.net/k151380/ 2015-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k151380-syngovia-rt-image-suite-fda-510k.jpg K151380 - syngo.via RT Image Suite K151380 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 2015. https://www.510kdatabase.net/k151448/ 2015-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k151448-continuum-and-trilogy-integrated-taper-fda-510k.jpg K151448 - Continuum and Trilogy Integrated Taper (IT) Acetabular Systems K151448 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Aug 2015. https://www.510kdatabase.net/k151533/ 2015-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k151533-respiratory-gating-for-scanners-fda-510k.jpg K151533 - Respiratory Gating for Scanners K151533 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Aug 2015. https://www.510kdatabase.net/k150745/ 2015-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k150745-syngoct-single-source-dual-energy-fda-510k.jpg K150745 - syngo.CT Single Source Dual Energy K150745 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 2015. https://www.510kdatabase.net/k150757/ 2015-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k150757-syngoct-dual-energy-fda-510k.jpg K150757 - syngo.CT Dual Energy K150757 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 2015. https://www.510kdatabase.net/k151353/ 2015-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k151353-syngomr-neurology-syngomr-oncology-fda-510k.jpg K151353 - syngo.MR Neurology, syngo.MR Oncology K151353 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 2015. https://www.510kdatabase.net/k151373/ 2015-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k151373-corvocet-coaxial-introducer-fda-510k.jpg K151373 - Corvocet Coaxial Introducer K151373 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Aug 2015. https://www.510kdatabase.net/k151657/ 2015-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k151657-shielded-applicator-set-cervical-stop-fda-510k.jpg K151657 - Shielded Applicator Set, Cervical Stop K151657 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Aug 2015. https://www.510kdatabase.net/k152054/ 2015-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k152054-confida-adaptive-sheath-fda-510k.jpg K152054 - Confida Adaptive Sheath K152054 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Aug 2015. https://www.510kdatabase.net/k150614/ 2015-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k150614-reveal-linq-fda-510k.jpg K150614 - Reveal LINQ K150614 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Aug 2015. https://www.510kdatabase.net/k151000/ 2015-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k151000-o-arm-o2-imaging-system-fda-510k.jpg K151000 - O-Arm O2 Imaging System K151000 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medtronic, Inc.. Cleared Aug 2015. https://www.510kdatabase.net/k151128/ 2015-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k151128-capstone-spinal-system-clydesdale-fda-510k.jpg K151128 - CAPSTONE Spinal System, CLYDESDALE Spinal System K151128 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Aug 2015. https://www.510kdatabase.net/k151235/ 2015-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k151235-medline-foot-plates-and-screws-fda-510k.jpg K151235 - Medline Foot Plates and Screws K151235 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medline Industries, Inc.. Cleared Aug 2015. https://www.510kdatabase.net/k151802/ 2015-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k151802-resolution-clip-fda-510k.jpg K151802 - Resolution Clip K151802 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Aug 2015. https://www.510kdatabase.net/k150692/ 2015-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k150692-axios-stent-with-electrocautery-fda-510k.jpg K150692 - AXIOS Stent with Electrocautery Enhanced Delivery System K150692 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Aug 2015. https://www.510kdatabase.net/k142829/ 2015-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k142829-flexor-tuohy-borst-side-arm-introducer-fda-510k.jpg K142829 - Flexor Tuohy-Borst Side-Arm Introducer, Ansel Modification K142829 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Jul 2015. https://www.510kdatabase.net/k150699/ 2015-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k150699-bard-lubriguard-foley-catheter-fda-510k.jpg K150699 - Bard LubriGuard Foley Catheter K150699 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jul 2015. https://www.510kdatabase.net/k151105/ 2015-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k151105-smith-and-nephew-suture-anchors-50mm-fda-510k.jpg K151105 - Smith and Nephew Suture Anchors - 5.0mm Absorbable Polymer Anchor, Smith and Nephew Suture Anchors - TAG Bioraptor Suture Anchor 7209317, 7209318, Smith and Nephew Suture Anchors - Bioraptor 2.3 PK Suture Anchor, Smith and Nephew Suture Anchors - Osteoraptor Suture Anchor, Smith and Nephew Suture Anchors - Twinfix Ultra HA Suture Anchor, Smith and Nephew Suture Anchors - OSTEORAPTOR Curved Suture Anchors, Smith and Nephew Suture Anchors - Ultra Fast-Fix Meniscal Repair System, Ultra Fa K151105 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 2015. https://www.510kdatabase.net/k142819/ 2015-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k142819-shuttle-sl-flexor-tuohy-borst-side-arm-fda-510k.jpg K142819 - Shuttle SL Flexor Tuohy-Borst Side-Arm Introducer Set K142819 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Jul 2015. https://www.510kdatabase.net/k143082/ 2015-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k143082-iv-administration-sets-with-200microm-fda-510k.jpg K143082 - IV Administration Sets with 200(micro)m Blood Filter K143082 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Jul 2015. https://www.510kdatabase.net/k151395/ 2015-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k151395-immunalysis-eddp-specific-urine-enzyme-fda-510k.jpg K151395 - Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control Sets K151395 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Immunalysis Corporation. Cleared Jul 2015. https://www.510kdatabase.net/k151628/ 2015-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k151628-medline-enfit-connectors-fda-510k.jpg K151628 - Medline ENFit Connectors K151628 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medline Industries, Inc.. Cleared Jul 2015. https://www.510kdatabase.net/k143133/ 2015-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k143133-renasys-ez-max-negative-pressure-wound-fda-510k.jpg K143133 - RENASYS¿ EZ MAX Negative Pressure Wound Therapy Device, RENASYS¿ AB Abdominal Dressing Kit with Soft Port Device K143133 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 2015. https://www.510kdatabase.net/k151532/ 2015-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k151532-kyphon-element-inflatable-bone-tamp-fda-510k.jpg K151532 - KYPHON ELEMENT Inflatable Bone Tamp K151532 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic, Inc.. Cleared Jul 2015. https://www.510kdatabase.net/k151676/ 2015-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k151676-retracta-detachable-embolization-coil-fda-510k.jpg K151676 - Retracta Detachable Embolization Coil K151676 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Jul 2015. https://www.510kdatabase.net/k151858/ 2015-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k151858-caiman-seal-and-cut-technology-fda-510k.jpg K151858 - Caiman Seal and Cut Technology K151858 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Jul 2015. https://www.510kdatabase.net/k143322/ 2015-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k143322-medline-natural-lubricating-liquid-fda-510k.jpg K143322 - Medline Natural Lubricating Liquid K143322 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Medline Industries, Inc.. Cleared Jul 2015. https://www.510kdatabase.net/k150066/ 2015-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k150066-exactech-alteon-monobloc-revision-stem-fda-510k.jpg K150066 - Exactech Alteon Monobloc Revision Stem K150066 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Jul 2015. https://www.510kdatabase.net/k151696/ 2015-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k151696-caiman-seal-and-cut-technology-fda-510k.jpg K151696 - Caiman Seal and Cut Technology K151696 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Jul 2015. https://www.510kdatabase.net/k143687/ 2015-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k143687-advia-centaur-follicle-stimulating-fda-510k.jpg K143687 - ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material K143687 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Jul 2015. https://www.510kdatabase.net/k150839/ 2015-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k150839-3d-interstitial-ring-applicator-set-60-fda-510k.jpg K150839 - 3D Interstitial Ring Applicator Set 60, 3D Interstitial Ring Applicator Set 90, Ring Applicator Set 45, Ring Applicator Set 60, Ring Applicator Set 90 K150839 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Jul 2015. https://www.510kdatabase.net/k151486/ 2015-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k151486-biograph-mct-and-mct-flow-petct-scanners-fda-510k.jpg K151486 - Biograph mCT and mCT Flow PET/CT Scanners K151486 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 2015. https://www.510kdatabase.net/k142965/ 2015-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k142965-virtuoso-system-for-ihc-pr-1e2-using-fda-510k.jpg K142965 - Virtuoso System for IHC PR (1E2) using iScan HT K142965 is a FDA 510(k) cleared pathology medical device. Manufacturer: Ventana Medical Systems, Inc.. Cleared Jul 2015. https://www.510kdatabase.net/k150850/ 2015-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k150850-refobacin-bone-cement-r-fda-510k.jpg K150850 - Refobacin Bone Cement R K150850 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jul 2015. https://www.510kdatabase.net/k151326/ 2015-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k151326-renasys-ez-plus-negative-pressure-fda-510k.jpg K151326 - RENASYS¿ EZ PLUS Negative Pressure Wound Therapy Device K151326 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 2015. https://www.510kdatabase.net/k151523/ 2015-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k151523-uncoated-tubing-and-connector-components-fda-510k.jpg K151523 - Uncoated Tubing and Connector Components K151523 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Jul 2015. https://www.510kdatabase.net/k143115/ 2015-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k143115-the-versajet-ii-hydrosurgery-system-fda-510k.jpg K143115 - The VersaJet II Hydrosurgery System K143115 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 2015. https://www.510kdatabase.net/k151566/ 2015-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k151566-abbott-architect-total-t4-calibrators-fda-510k.jpg K151566 - Abbott ARCHITECT Total T4 Calibrators K151566 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jul 2015. https://www.510kdatabase.net/k142970/ 2015-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k142970-sterilcontainer-s-system-fda-510k.jpg K142970 - SterilContainer S System K142970 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Aesculap, Inc.. Cleared Jul 2015. https://www.510kdatabase.net/k150632/ 2015-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k150632-hypervisor-ix-monitoring-system-fda-510k.jpg K150632 - Hypervisor IX Monitoring System K150632 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Jul 2015. https://www.510kdatabase.net/k151534/ 2015-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k151534-hemosil-d-dimer-hs-fda-510k.jpg K151534 - HemosIL D-Dimer HS K151534 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jul 2015. https://www.510kdatabase.net/k143745/ 2015-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k143745-arthrex-corkscrew-and-swivelock-suture-fda-510k.jpg K143745 - Arthrex Corkscrew and SwiveLock Suture Anchors K143745 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jul 2015. https://www.510kdatabase.net/k150039/ 2015-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k150039-microscan-dried-gram-positive-miccombo-fda-510k.jpg K150039 - MicroScan Dried Gram Positive MIC/Combo Panels with vancomycin (0.25-64 mcg/mL) K150039 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Jul 2015. https://www.510kdatabase.net/k150477/ 2015-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k150477-3m-comply-indicator-tape-for-ethylene-fda-510k.jpg K150477 - 3M Comply Indicator Tape for Ethylene Oxide (EO) Sterilization K150477 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Jul 2015. https://www.510kdatabase.net/k150670/ 2015-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k150670-stratafix-spiral-pds-plus-knotless-fda-510k.jpg K150670 - STRATAFIX Spiral PDS Plus Knotless Tissue Control Device K150670 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Jul 2015. https://www.510kdatabase.net/k151254/ 2015-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k151254-cardiosave-hybrid-intra-aortic-balloon-fda-510k.jpg K151254 - CARDIOSAVE Hybrid Intra-Aortic Balloon Pump K151254 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Jul 2015. https://www.510kdatabase.net/k150889/ 2015-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k150889-suture-wires-and-wire-loops-fda-510k.jpg K150889 - Suture Wires and Wire Loops K150889 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jul 2015. https://www.510kdatabase.net/k151478/ 2015-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k151478-wondfo-cr3-keyless-split-sample-cup-fda-510k.jpg K151478 - Wondfo CR3 Keyless Split Sample Cup K151478 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.. Cleared Jul 2015. https://www.510kdatabase.net/k151497/ 2015-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k151497-en-snare-endovascular-snare-system-fda-510k.jpg K151497 - EN Snare Endovascular Snare System K151497 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jul 2015. https://www.510kdatabase.net/k150167/ 2015-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k150167-v60-anesthetic-vaporizer-fda-510k.jpg K150167 - V60 Anesthetic Vaporizer K150167 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Jun 2015. https://www.510kdatabase.net/k150925/ 2015-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k150925-immunalysis-benzoylecgonine-urine-fda-510k.jpg K150925 - Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set K150925 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Immunalysis Corporation. Cleared Jun 2015. https://www.510kdatabase.net/k151192/ 2015-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k151192-syngovia-mi-workflows-fda-510k.jpg K151192 - syngo.via MI Workflows K151192 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 2015. https://www.510kdatabase.net/k150257/ 2015-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k150257-preludeease-hydrophilic-sheath-fda-510k.jpg K150257 - PreludeEASE Hydrophilic Sheath Introducer K150257 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jun 2015. https://www.510kdatabase.net/k151230/ 2015-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k151230-arthrex-fibertak-anchors-fda-510k.jpg K151230 - Arthrex FiberTak Anchors K151230 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jun 2015. https://www.510kdatabase.net/k142596/ 2015-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k142596-infusomat-space-volumetric-infusion-pump-fda-510k.jpg K142596 - Infusomat Space Volumetric Infusion Pump K142596 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Jun 2015. https://www.510kdatabase.net/k150667/ 2015-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k150667-true-dilatation-balloon-valvuloplasty-fda-510k.jpg K150667 - True Dilatation Balloon Valvuloplasty Catheter K150667 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jun 2015. https://www.510kdatabase.net/k150231/ 2015-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k150231-navigated-disc-prep-instruments-and-fda-510k.jpg K150231 - Navigated Disc Prep Instruments and CAPSTONE Trials K150231 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Jun 2015. https://www.510kdatabase.net/k150882/ 2015-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k150882-edwards-suture-fastening-system-fda-510k.jpg K150882 - Edwards Suture Fastening System K150882 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Jun 2015. https://www.510kdatabase.net/k150303/ 2015-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k150303-xxl-vascular-balloon-dilatation-catheter-fda-510k.jpg K150303 - XXL Vascular Balloon Dilatation Catheter K150303 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Jun 2015. https://www.510kdatabase.net/k142783/ 2015-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k142783-heartway-electrically-powered-fda-510k.jpg K142783 - HEARTWAY Electrically Powered Wheelchair P27 K142783 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Heartway Medical Products Co., Ltd.. Cleared Jun 2015. https://www.510kdatabase.net/k150080/ 2015-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k150080-dc-8dc-8-prodc-8-cvdc-8-expdc-8s-fda-510k.jpg K150080 - DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S K150080 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Jun 2015. https://www.510kdatabase.net/k150319/ 2015-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k150319-micrusframe-1018-deltafill-18-fda-510k.jpg K150319 - MICRUSFRAME 10/18, DELTAFILL 18, DELTAXSFT 10, GALAXY G3 FILL/XSFT STRETCH RESISTANT MICROCOIL DELIVERY SYSTEMS K150319 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Jun 2015. https://www.510kdatabase.net/k150135/ 2015-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k150135-divergence-l-anterioroblique-lumbar-fda-510k.jpg K150135 - DIVERGENCE-L Anterior/Oblique Lumbar Fusion System K150135 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Jun 2015. https://www.510kdatabase.net/k150867/ 2015-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k150867-affixus-tibial-nailing-system-fda-510k.jpg K150867 - Affixus Tibial Nailing System K150867 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jun 2015. https://www.510kdatabase.net/k142559/ 2015-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k142559-elevate-spinal-system-fda-510k.jpg K142559 - ELEVATE Spinal System K142559 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Jun 2015. https://www.510kdatabase.net/k143380/ 2015-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k143380-phasix-st-mesh-fda-510k.jpg K143380 - Phasix ST Mesh K143380 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jun 2015. https://www.510kdatabase.net/k150186/ 2015-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k150186-chariot-guiding-sheath-fda-510k.jpg K150186 - Chariot Guiding Sheath K150186 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Jun 2015. https://www.510kdatabase.net/k150332/ 2015-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k150332-freestyle-lite-blood-glucose-fda-510k.jpg K150332 - FreeStyle Lite Blood Glucose Monitoring System K150332 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jun 2015. https://www.510kdatabase.net/k150531/ 2015-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k150531-freestyle-freedom-lite-blood-glucose-fda-510k.jpg K150531 - FreeStyle Freedom Lite Blood Glucose Monitoring System K150531 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jun 2015. https://www.510kdatabase.net/k151203/ 2015-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k151203-immunalysis-cannabinoids-urine-enzyme-fda-510k.jpg K151203 - Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control Set K151203 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Immunalysis Corporation. Cleared Jun 2015. https://www.510kdatabase.net/k150552/ 2015-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k150552-ellipse-and-protex-ct-occipito-cervico-fda-510k.jpg K150552 - ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS K150552 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Jun 2015. https://www.510kdatabase.net/k141531/ 2015-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k141531-power-trialysis-slim-cath-short-term-fda-510k.jpg K141531 - POWER-TRIALYSIS SLIM-CATH SHORT-TERM DIALYSIS CATHETER K141531 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jun 2015. https://www.510kdatabase.net/k143321/ 2015-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k143321-itst-intertrochantericsubtrochanteric-fda-510k.jpg K143321 - ITST Intertrochanteric/Subtrochanteric Fixation System K143321 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared May 2015. https://www.510kdatabase.net/k150679/ 2015-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k150679-endovive-initial-placement-standard-fda-510k.jpg K150679 - EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector K150679 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared May 2015. https://www.510kdatabase.net/k150890/ 2015-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k150890-exactech-optetrak-logic-cc-fda-510k.jpg K150890 - Exactech Optetrak Logic CC K150890 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared May 2015. https://www.510kdatabase.net/k141320/ 2015-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k141320-lzi-oral-fluid-cannabinoids-enzyme-fda-510k.jpg K141320 - LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators and LZI Oral Fluid Cannabinoids Controls K141320 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Lin-Zhi International, Inc.. Cleared May 2015. https://www.510kdatabase.net/k150130/ 2015-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k150130-ascendant-tm-cervical-spacer-system-fda-510k.jpg K150130 - Ascendant TM Cervical Spacer System K150130 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared May 2015. https://www.510kdatabase.net/k150802/ 2015-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k150802-heavy-double-flexible-tipped-wire-guide-fda-510k.jpg K150802 - Heavy Double Flexible Tipped Wire Guide K150802 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared May 2015. https://www.510kdatabase.net/k150117/ 2015-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k150117-medtronic-patient-asistant-fda-510k.jpg K150117 - Medtronic Patient Asistant K150117 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared May 2015. https://www.510kdatabase.net/k151110/ 2015-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k151110-intersept-filtered-cardiotomy-reservoir-fda-510k.jpg K151110 - Intersept Filtered Cardiotomy Reservoir K151110 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared May 2015. https://www.510kdatabase.net/k150420/ 2015-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k150420-centricity-universal-viewer-fda-510k.jpg K150420 - Centricity Universal Viewer K150420 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared May 2015. https://www.510kdatabase.net/k140654/ 2015-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k140654-hemoglobin-a1c-assay-hemoglobin-a1c-fda-510k.jpg K140654 - Hemoglobin A1c Assay, Hemoglobin A1c Calibrators, Hemoglobin A1c Controls K140654 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared May 2015. https://www.510kdatabase.net/k142648/ 2015-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k142648-spinedesign-spine-surgery-planning-fda-510k.jpg K142648 - SPINEDESIGN Spine Surgery Planning (Software Application) K142648 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared May 2015. https://www.510kdatabase.net/k150733/ 2015-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k150733-vital-port-vascular-access-system-fda-510k.jpg K150733 - Vital-Port Vascular Access System Power Injectable Port K150733 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cook Incorporated. Cleared May 2015. https://www.510kdatabase.net/k142724/ 2015-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k142724-biofoam-bone-wedge-fda-510k.jpg K142724 - BIOFOAM Bone Wedge K142724 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared May 2015. https://www.510kdatabase.net/k143502/ 2015-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k143502-immunalysis-opiates-urine-enzyme-fda-510k.jpg K143502 - Immunalysis Opiates Urine Enzyme Immunoassay, Immunalysis Opiates Urine Calibrators 300, Immunalysis Opiates Urine Calibrators 2000, Immunalysis Multi-Drug Controls K143502 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Immunalysis Corporation. Cleared May 2015. https://www.510kdatabase.net/k150090/ 2015-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k150090-zimmer-persona-personalized-knee-system-fda-510k.jpg K150090 - Zimmer Persona Personalized Knee System K150090 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared May 2015. https://www.510kdatabase.net/k150453/ 2015-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k150453-tula-iontophoresis-system-with-earset-fda-510k.jpg K150453 - TULA Iontophoresis System with Earset K150453 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Acclarent, Inc.. Cleared May 2015. https://www.510kdatabase.net/k150785/ 2015-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k150785-syngoct-dental-fda-510k.jpg K150785 - syngo.CT Dental K150785 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 2015. https://www.510kdatabase.net/k150284/ 2015-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k150284-is4000-da-vinci-endowrist-instruments-fda-510k.jpg K150284 - IS4000 da Vinci EndoWrist Instruments K150284 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared May 2015. https://www.510kdatabase.net/k151078/ 2015-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k151078-arthrex-retrofusion-screw-fda-510k.jpg K151078 - Arthrex RetroFusion Screw K151078 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared May 2015. https://www.510kdatabase.net/k150458/ 2015-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k150458-exactech-equinoxe-reverse-shoulder-fda-510k.jpg K150458 - Exactech Equinoxe Reverse Shoulder 46x21mm Glenosphere K150458 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared May 2015. https://www.510kdatabase.net/k150970/ 2015-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k150970-coda-lp-balloon-catheter-fda-510k.jpg K150970 - Coda LP Balloon Catheter K150970 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared May 2015. https://www.510kdatabase.net/k150152/ 2015-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k150152-the-octane-straight-intervertebral-fda-510k.jpg K150152 - The Octane Straight Intervertebral Fusion Device, Ti Coated K150152 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared May 2015. https://www.510kdatabase.net/k150345/ 2015-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k150345-magic3-go-intermittent-urinary-catheter-fda-510k.jpg K150345 - Magic3 Go Intermittent Urinary Catheter K150345 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 2015. https://www.510kdatabase.net/k150213/ 2015-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k150213-subtalar-spacer-system-sts-fda-510k.jpg K150213 - Subtalar Spacer System (STS) K150213 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared May 2015. https://www.510kdatabase.net/k150530/ 2015-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k150530-level-sensor-level-sensor-tape-fda-510k.jpg K150530 - Level Sensor, Level Sensor Tape K150530 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared May 2015. https://www.510kdatabase.net/k150636/ 2015-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k150636-variseed-90-fda-510k.jpg K150636 - VariSeed 9.0 K150636 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared May 2015. https://www.510kdatabase.net/k150706/ 2015-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k150706-vitalbeam-fda-510k.jpg K150706 - VitalBeam K150706 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared May 2015. https://www.510kdatabase.net/k143147/ 2015-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k143147-gemini-bonded-sterilization-wrap-fda-510k.jpg K143147 - Gemini Bonded Sterilization Wrap K143147 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared May 2015. https://www.510kdatabase.net/k150403/ 2015-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k150403-advia-centaur-tsh3-ultra-fda-510k.jpg K150403 - ADVIA Centaur TSH3-Ultra K150403 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared May 2015. https://www.510kdatabase.net/k150522/ 2015-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k150522-g7-dual-mobility-system-fda-510k.jpg K150522 - G7 Dual Mobility System K150522 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared May 2015. https://www.510kdatabase.net/k150626/ 2015-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k150626-rush-medullary-pins-fda-510k.jpg K150626 - Rush Medullary Pins K150626 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared May 2015. https://www.510kdatabase.net/k150818/ 2015-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k150818-versa-fx-femoral-fixation-system-versa-fda-510k.jpg K150818 - Versa-Fx Femoral Fixation System, Versa-Fx II Femoral Fixation System, Free-Lock Femoral Fixation System K150818 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared May 2015. https://www.510kdatabase.net/k150955/ 2015-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k150955-elecsys-progesterone-iii-cal-check-5-fda-510k.jpg K150955 - Elecsys Progesterone III Cal Check 5 K150955 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared May 2015. https://www.510kdatabase.net/k142979/ 2015-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k142979-renasys-fda-510k.jpg K142979 - RENASYS K142979 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Apr 2015. https://www.510kdatabase.net/k150252/ 2015-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k150252-phalinx-hammertoe-system-fda-510k.jpg K150252 - PHALINX Hammertoe System K150252 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Apr 2015. https://www.510kdatabase.net/k150456/ 2015-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k150456-arthrex-plates-screws-and-staples-fda-510k.jpg K150456 - Arthrex Plates, Screws, and Staples K150456 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Apr 2015. https://www.510kdatabase.net/k150520/ 2015-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k150520-darco-locking-bone-plate-system-fda-510k.jpg K150520 - DARCO Locking Bone Plate System K150520 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Apr 2015. https://www.510kdatabase.net/k150837/ 2015-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k150837-is4000-small-clip-applier-is4000-long-fda-510k.jpg K150837 - IS4000 Small Clip Applier, IS4000 Long Bipolar Forceps K150837 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Apr 2015. https://www.510kdatabase.net/k150286/ 2015-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k150286-medline-enteral-feeding-sets-fda-510k.jpg K150286 - Medline Enteral Feeding Sets K150286 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medline Industries, Inc.. Cleared Apr 2015. https://www.510kdatabase.net/k150791/ 2015-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k150791-healgen-secobarbital-teststrip-fda-510k.jpg K150791 - Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test (Strip, Cassette, Cup, Dip Card), Healgen Methadone Test (Strip, Cassette, Cup, Dip Card) K150791 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Healgen Scientific, LLC. Cleared Apr 2015. https://www.510kdatabase.net/k150501/ 2015-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k150501-zimmer-nexel-total-elbow-ulnar-cement-fda-510k.jpg K150501 - Zimmer Nexel Total Elbow Ulnar Cement Diverter K150501 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Apr 2015. https://www.510kdatabase.net/k141999/ 2015-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k141999-advia-centaur-tsh-fda-510k.jpg K141999 - ADVIA CENTAUR TSH K141999 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Apr 2015. https://www.510kdatabase.net/k150235/ 2015-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k150235-clearsign-ii-amplifier-40-channels-fda-510k.jpg K150235 - CLEARSIGN II Amplifier, 40 channels, CLEARSIGN II Amplifier, 80 channels, CLEARSIGN II Amplifier, 120 channels, CLEARSIGN II Amplifer, 160 channels K150235 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Apr 2015. https://www.510kdatabase.net/k143739/ 2015-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k143739-polarstem-collared-standard-and-fda-510k.jpg K143739 - POLARSTEM Collared (Standard and Lateral) and Valgus Femoral Stem with Ti/HA K143739 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Apr 2015. https://www.510kdatabase.net/k142083/ 2015-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k142083-true-flow-valvuloplasty-perfusion-fda-510k.jpg K142083 - TRUE FLOW VALVULOPLASTY PERFUSION CATHETER K142083 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 2015. https://www.510kdatabase.net/k143416/ 2015-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k143416-somatom-definition-flash-va48-fda-510k.jpg K143416 - SOMATOM Definition Flash (VA48) K143416 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 2015. https://www.510kdatabase.net/k143333/ 2015-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k143333-revital-ox-resert-solution-test-strip-fda-510k.jpg K143333 - Revital-Ox RESERT Solution Test Strip K143333 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Apr 2015. https://www.510kdatabase.net/k142445/ 2015-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k142445-pinpoint-gt-safety-introducer-needle-fda-510k.jpg K142445 - PINPOINT GT SAFETY INTRODUCER NEEDLE K142445 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 2015. https://www.510kdatabase.net/k141932/ 2015-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k141932-aquios-cl-flow-cytometer-aquios-tetra-fda-510k.jpg K141932 - AQUIOS CL FLOW CYTOMETER, AQUIOS TETRA-1 PANEL,AQUIOS TETRA-2+PANEL, AQUIOS IMMUNO-TROL, AQUIOS IMMUNO-TROL LOW, AQUIOS K141932 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Apr 2015. https://www.510kdatabase.net/k150204/ 2015-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k150204-dc-70dc-70tdc-70-prodc-70-exp-fda-510k.jpg K150204 - DC-70/DC-70T/DC-70 PRO/DC-70 EXP Diagnostic Ultrasound Systems K150204 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Apr 2015. https://www.510kdatabase.net/k143255/ 2015-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k143255-prelude-snap-splittable-sheath-fda-510k.jpg K143255 - Prelude SNAP Splittable Sheath Introducer K143255 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Apr 2015. https://www.510kdatabase.net/k143659/ 2015-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k143659-equinoxe-mega-prosthesis-fda-510k.jpg K143659 - Equinoxe Mega Prosthesis K143659 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Apr 2015. https://www.510kdatabase.net/k143702/ 2015-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k143702-arthrex-blunt-tip-screws-with-fiber-tape-fda-510k.jpg K143702 - Arthrex Blunt Tip Screws with Fiber Tape K143702 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Apr 2015. https://www.510kdatabase.net/k150567/ 2015-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k150567-medtronic-bio-medicus-cannula-fda-510k.jpg K150567 - MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT K150567 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Apr 2015. https://www.510kdatabase.net/den140039/ 2015-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/den140039-nova-view-automated-fluorescense-fda-510k.jpg DEN140039 - NOVA View Automated Fluorescense Microscope DEN140039 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Apr 2015. https://www.510kdatabase.net/k143019/ 2015-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k143019-cd-horizon-spinal-system-ipc-powerease-fda-510k.jpg K143019 - CD HORIZON Spinal System, IPC POWEREASE System K143019 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Apr 2015. https://www.510kdatabase.net/k143400/ 2015-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k143400-somatom-definition-asas-fda-510k.jpg K143400 - SOMATOM Definition AS/AS+ K143400 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 2015. https://www.510kdatabase.net/k150155/ 2015-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k150155-nova-lite-dapi-ana-kit-fda-510k.jpg K150155 - NOVA Lite DAPI ANA Kit K150155 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Apr 2015. https://www.510kdatabase.net/k150602/ 2015-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k150602-cr3-keyless-split-sample-cup-morphine-fda-510k.jpg K150602 - CR3 Keyless Split Sample Cup Morphine - Methamphetamine K150602 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.. Cleared Apr 2015. https://www.510kdatabase.net/k143401/ 2015-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k143401-somatom-definition-edge-fda-510k.jpg K143401 - SOMATOM Definition Edge K143401 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 2015. https://www.510kdatabase.net/k143749/ 2015-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k143749-arthrex-distal-radius-system-fda-510k.jpg K143749 - Arthrex Distal Radius System K143749 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Apr 2015. https://www.510kdatabase.net/k141687/ 2015-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k141687-aesculap-meithke-progav-20-adjustable-fda-510k.jpg K141687 - AESCULAP - MEITHKE PROGAV 2.0 ADJUSTABLE SHUNT SYSTEM K141687 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Apr 2015. https://www.510kdatabase.net/k143132/ 2015-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k143132-is4000-8mm-harmonic-ace-curved-shears-fda-510k.jpg K143132 - IS4000 8mm Harmonic ACE Curved Shears K143132 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Apr 2015. https://www.510kdatabase.net/k143480/ 2015-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k143480-euphora-rapid-exchange-balloon-fda-510k.jpg K143480 - Euphora Rapid Exchange Balloon Dilatation Catheter K143480 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Apr 2015. https://www.510kdatabase.net/k150510/ 2015-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k150510-total-bilirubin-fda-510k.jpg K150510 - Total Bilirubin K150510 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Apr 2015. https://www.510kdatabase.net/k142218/ 2015-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k142218-coalition-agx-plate-and-coalition-agx-fda-510k.jpg K142218 - Coalition AGX Plate and Coalition AGX Spacer K142218 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Mar 2015. https://www.510kdatabase.net/k142723/ 2015-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k142723-advia-centaur-cortisol-cor-assy-fda-510k.jpg K142723 - ADVIA Centaur Cortisol (COR) Assy K142723 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Mar 2015. https://www.510kdatabase.net/k143165/ 2015-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k143165-herbertwhipple-bone-screw-system-fda-510k.jpg K143165 - Herbert/Whipple Bone Screw System, Herbert/Whipple Bone Screw System, Herbert Cannulated Bone Screw System, Herbert Mini Bone Screw K143165 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Mar 2015. https://www.510kdatabase.net/k141527/ 2015-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k141527-depuy-synthes-variable-angle-locking-fda-510k.jpg K141527 - DEPUY SYNTHES VARIABLE ANGLE LOCKING HAND SYSTEM K141527 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Mar 2015. https://www.510kdatabase.net/k150529/ 2015-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k150529-site-rite-prevue-ultrasound-system-fda-510k.jpg K150529 - Site-Rite Prevue Ultrasound System, Site-Rite Prevue+ Ultrasound System K150529 is a FDA 510(k) cleared radiology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 2015. https://www.510kdatabase.net/k150551/ 2015-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k150551-gore-seamguard-reinforcement-fda-510k.jpg K150551 - GORE SEAMGUARD Reinforcement K150551 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Mar 2015. https://www.510kdatabase.net/k150192/ 2015-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k150192-scenium-fda-510k.jpg K150192 - Scenium K150192 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2015. https://www.510kdatabase.net/k141322/ 2015-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k141322-advance-enforcer-35-focal-force-pta-fda-510k.jpg K141322 - ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER K141322 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Mar 2015. https://www.510kdatabase.net/k142822/ 2015-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k142822-pliasure-polyglycolide-synthetic-fda-510k.jpg K142822 - PLIASURE Polyglycolide Synthetic Absorbable Suture K142822 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Mar 2015. https://www.510kdatabase.net/k143361/ 2015-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k143361-mammo-workstation-fda-510k.jpg K143361 - Mammo Workstation K143361 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Mar 2015. https://www.510kdatabase.net/k143409/ 2015-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k143409-somatom-definition-as-open-va48-fda-510k.jpg K143409 - SOMATOM Definition AS Open (VA48) K143409 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2015. https://www.510kdatabase.net/k142117/ 2015-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k142117-invision-total-ankle-revision-system-fda-510k.jpg K142117 - INVISION TOTAL ANKLE REVISION SYSTEM K142117 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Mar 2015. https://www.510kdatabase.net/k142706/ 2015-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k142706-modified-onflex-mesh-fda-510k.jpg K142706 - Modified ONFLEX Mesh K142706 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 2015. https://www.510kdatabase.net/k143073/ 2015-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k143073-affinity-nt-oxygenator-affinity-nt-fda-510k.jpg K143073 - Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Carmeda Biosurface K143073 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Mar 2015. https://www.510kdatabase.net/k143083/ 2015-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k143083-bio-medicus-pediatric-cannula-and-fda-510k.jpg K143083 - Bio-Medicus Pediatric Cannula and Introducers K143083 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Mar 2015. https://www.510kdatabase.net/k150503/ 2015-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k150503-echo-bi-metric-microplasty-line-fda-510k.jpg K150503 - Echo Bi-Metric Microplasty Line Extension K150503 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Mar 2015. https://www.510kdatabase.net/k143096/ 2015-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k143096-sl-plus-mia-and-sl-plus-femoral-stems-fda-510k.jpg K143096 - SL-PLUS MIA and SL-PLUS Femoral Stems with Ti/HA K143096 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Mar 2015. https://www.510kdatabase.net/k142711/ 2015-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k142711-onflex-mesh-fda-510k.jpg K142711 - ONFLEX Mesh K142711 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 2015. https://www.510kdatabase.net/k150422/ 2015-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k150422-eopa-3d-arterial-cannula-fda-510k.jpg K150422 - EOPA 3D Arterial Cannula K150422 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Mar 2015. https://www.510kdatabase.net/k133788/ 2015-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k133788-cook-holmium-laser-fiber-fda-510k.jpg K133788 - COOK HOLMIUM LASER FIBER K133788 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cook Incorporated. Cleared Mar 2015. https://www.510kdatabase.net/k142988/ 2015-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k142988-sleepware-g3-fda-510k.jpg K142988 - Sleepware G3 K142988 is a FDA 510(k) cleared neurology medical device. Manufacturer: Respironics, Inc.. Cleared Mar 2015. https://www.510kdatabase.net/k142873/ 2015-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k142873-optifix-fixation-system-straight-5mm-x-fda-510k.jpg K142873 - OptiFix Fixation System - Straight 5mm X 39 cm - 30 absorbable fasteners, OptiFix Fixation System - Straight 5mm x 39 cm - 15 absorbable fasteners K142873 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 2015. https://www.510kdatabase.net/k143316/ 2015-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k143316-attain-hybrid-guide-wire-fda-510k.jpg K143316 - Attain Hybrid Guide Wire K143316 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Mar 2015. https://www.510kdatabase.net/k141624/ 2015-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k141624-plastic-needle-with-mandrin-20-mm-fda-510k.jpg K141624 - PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH, BLUNT TIP,PLASTIC NEEDLE WITH MANDRIN, 2.0 MM DIAMETER, LENGTH 113 K141624 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Mar 2015. https://www.510kdatabase.net/k142808/ 2015-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k142808-capsure-fixation-system-straight-5mm-x-fda-510k.jpg K142808 - CapSure Fixation System-Straight 5mm x 37 cm-30 Permanent fasteners, CapSure Fixation System-Straight 5mm x 37 cm-15 Permanent fasteners K142808 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 2015. https://www.510kdatabase.net/k150275/ 2015-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k150275-immunalysis-6-acetylmorphine-urine-fda-510k.jpg K150275 - Immunalysis 6-Acetylmorphine Urine Enzyme Immunoassay, Immunalysis 6-Acetylmorphine Urine Calibrator, Immunalysis 6-Acetylmorphine Urine Controls K150275 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Immunalysis Corporation. Cleared Mar 2015. https://www.510kdatabase.net/k141655/ 2015-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k141655-quanta-flash-ro52-quanta-flash-ro52-fda-510k.jpg K141655 - QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLS K141655 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Mar 2015. https://www.510kdatabase.net/k141740/ 2015-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k141740-infinity-tm-total-ankle-system-fda-510k.jpg K141740 - INFINITY (TM) TOTAL ANKLE SYSTEM K141740 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Mar 2015. https://www.510kdatabase.net/k143331/ 2015-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k143331-zimmer-plates-and-screws-system-zps-fda-510k.jpg K143331 - Zimmer Plates and Screws System (ZPS) - Non-sterile ZPS K143331 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Mar 2015. https://www.510kdatabase.net/k150004/ 2015-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k150004-salvation-external-fixation-system-fda-510k.jpg K150004 - SALVATION External Fixation System K150004 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Mar 2015. https://www.510kdatabase.net/k150096/ 2015-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k150096-healgen-mdma-ecstacy-test-strip-fda-510k.jpg K150096 - Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card) K150096 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Healgen Scientific, LLC. Cleared Mar 2015. https://www.510kdatabase.net/k141867/ 2015-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k141867-accu-chek-aviva-connect-blood-glucose-fda-510k.jpg K141867 - ACCU-CHEK AVIVA CONNECT BLOOD GLUCOSE MONITORING SYSTEM K141867 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Mar 2015. https://www.510kdatabase.net/k142731/ 2015-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k142731-heartway-electrically-powered-fda-510k.jpg K142731 - HEARTWAY Electrically Powered Wheelchairs K142731 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Heartway Medical Products Co., Ltd.. Cleared Feb 2015. https://www.510kdatabase.net/k143576/ 2015-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k143576-exactech-ambassador-fda-510k.jpg K143576 - Exactech Ambassador K143576 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Feb 2015. https://www.510kdatabase.net/k142498/ 2015-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k142498-magnify-and-magnify-s-spacers-fda-510k.jpg K142498 - MAGNIFY and MAGNIFY-S Spacers K142498 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Feb 2015. https://www.510kdatabase.net/k142985/ 2015-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k142985-unicel-dxc-synchron-system-hdl-fda-510k.jpg K142985 - UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL Calibrator K142985 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Feb 2015. https://www.510kdatabase.net/k143373/ 2015-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k143373-immulite-2000-calcitonin-calibration-fda-510k.jpg K143373 - IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material K143373 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Feb 2015. https://www.510kdatabase.net/k143636/ 2015-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k143636-immulite-2000-androstenedione-fda-510k.jpg K143636 - IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin I Calibration Verification Material K143636 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Feb 2015. https://www.510kdatabase.net/k150179/ 2015-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k150179-cr3-keyless-split-sample-cup-oxycodone-fda-510k.jpg K150179 - CR3 Keyless Split Sample Cup Oxycodone - Cannabinoids K150179 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Guangzhou Wondfo Biotech Co., Ltd.. Cleared Feb 2015. https://www.510kdatabase.net/k142937/ 2015-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k142937-endoscope-sterilization-tray-fda-510k.jpg K142937 - Endoscope Sterilization Tray K142937 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Feb 2015. https://www.510kdatabase.net/k150121/ 2015-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k150121-zimmer-periarticular-plating-system-fda-510k.jpg K150121 - Zimmer Periarticular Plating System K150121 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Feb 2015. https://www.510kdatabase.net/k150246/ 2015-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k150246-medtronic-model-5392-external-pulse-fda-510k.jpg K150246 - Medtronic Model 5392 External Pulse Generator (EPG) K150246 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Feb 2015. https://www.510kdatabase.net/k141205/ 2015-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k141205-lzi-oral-fluid-6-acetylmorphine-enzyme-fda-510k.jpg K141205 - LZI ORAL FLUID 6-ACETYLMORPHINE ENZYME IMMUNOASSAY, LZI ORAL FLUID 6-ACETYLMORPHINE CALIBRATORS (5 ML), LZI ORAL FLUID 6 K141205 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Lin-Zhi International, Inc.. Cleared Feb 2015. https://www.510kdatabase.net/k141274/ 2015-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k141274-quanta-flash-2gp1-domain1-fda-510k.jpg K141274 - QUANTA FLASH ¿2GP1-DOMAIN1 K141274 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Feb 2015. https://www.510kdatabase.net/k143375/ 2015-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k143375-cd-horizon-spinal-system-medtronic-fda-510k.jpg K143375 - CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments K143375 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Feb 2015. https://www.510kdatabase.net/k141328/ 2015-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k141328-quanta-flash-ro60-quanta-flash-ro60-fda-510k.jpg K141328 - QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 CONTROLS K141328 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Feb 2015. https://www.510kdatabase.net/k141803/ 2015-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k141803-immunalysis-tramadol-urine-enzyme-fda-510k.jpg K141803 - IMMUNALYSIS TRAMADOL URINE ENZYME IMMUNOASSAY K141803 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Immunalysis Corporation. Cleared Feb 2015. https://www.510kdatabase.net/k143192/ 2015-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k143192-vanguard-360-revision-knee-system-fda-510k.jpg K143192 - Vanguard 360 Revision Knee System K143192 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Feb 2015. https://www.510kdatabase.net/k143226/ 2015-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k143226-visionaire-disposable-instruments-fda-510k.jpg K143226 - Visionaire Disposable Instruments K143226 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Feb 2015. https://www.510kdatabase.net/k143569/ 2015-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k143569-cd-horizon-spinal-system-fda-510k.jpg K143569 - CD HORIZON Spinal System K143569 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Feb 2015. https://www.510kdatabase.net/k143628/ 2015-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k143628-navigated-vertex-select-instruments-fda-510k.jpg K143628 - Navigated Vertex Select Instruments K143628 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Feb 2015. https://www.510kdatabase.net/k150178/ 2015-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k150178-cd-horizon-spinal-system-fda-510k.jpg K150178 - CD HORIZON SPINAL SYSTEM K150178 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Feb 2015. https://www.510kdatabase.net/k140980/ 2015-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k140980-ti-nasal-mask-fda-510k.jpg K140980 - TI NASAL MASK K140980 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Feb 2015. https://www.510kdatabase.net/k142472/ 2015-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k142472-voluson-e6-voluson-e8-voluson-e10-fda-510k.jpg K142472 - Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems K142472 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Feb 2015. https://www.510kdatabase.net/k142882/ 2015-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k142882-g7-freedom-and-offset-liners-freedom-fda-510k.jpg K142882 - G7 Freedom and Offset Liners, Freedom Head, Size 32 K142882 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Feb 2015. https://www.510kdatabase.net/k150073/ 2015-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k150073-micronail-distal-radius-system-fda-510k.jpg K150073 - MICRONAIL Distal Radius System K150073 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Feb 2015. https://www.510kdatabase.net/k150050/ 2015-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k150050-acuson-p500-diagnostic-ultrasound-system-fda-510k.jpg K150050 - ACUSON P500 Diagnostic Ultrasound System K150050 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 2015. https://www.510kdatabase.net/k143471/ 2015-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k143471-vertex-reconstruction-system-fda-510k.jpg K143471 - VERTEX Reconstruction System K143471 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Feb 2015. https://www.510kdatabase.net/k143500/ 2015-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k143500-immunalysis-amphetamine-urine-enzyme-fda-510k.jpg K143500 - Immunalysis Amphetamine Urine Enzyme Immunoassay, Immunalysis Amphetamine Urine Calibrator, Immunalysis Amphetamine Urine Control Set K143500 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Immunalysis Corporation. Cleared Feb 2015. https://www.510kdatabase.net/k143618/ 2015-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k143618-kirschner-wires-steinmann-pins-fda-510k.jpg K143618 - Kirschner Wires, Steinmann Pins K143618 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Feb 2015. https://www.510kdatabase.net/k150028/ 2015-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k150028-zimmer-segmental-system-xt-components-fda-510k.jpg K150028 - Zimmer Segmental System XT Components K150028 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Feb 2015. https://www.510kdatabase.net/k143172/ 2015-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k143172-acl-smart-system-fda-510k.jpg K143172 - ACL SMART System K143172 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Feb 2015. https://www.510kdatabase.net/k143543/ 2015-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k143543-prelude-pf-patellae-fda-510k.jpg K143543 - Prelude PF Patellae K143543 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jan 2015. https://www.510kdatabase.net/k143633/ 2015-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k143633-creo-stabilization-system-fda-510k.jpg K143633 - CREO Stabilization System K143633 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Jan 2015. https://www.510kdatabase.net/k141210/ 2015-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k141210-quanta-flash-ss-b-quanta-flash-ss-b-fda-510k.jpg K141210 - QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLS K141210 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Jan 2015. https://www.510kdatabase.net/k143452/ 2015-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k143452-logiq-p9-logiq-p7-fda-510k.jpg K143452 - LOGIQ P9, LOGIQ P7 K143452 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Jan 2015. https://www.510kdatabase.net/k143680/ 2015-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k143680-advia-centaur-ige-master-curve-material-fda-510k.jpg K143680 - ADVIA Centaur IgE Master Curve Material K143680 is a FDA 510(k) cleared immunology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Jan 2015. https://www.510kdatabase.net/k142552/ 2015-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k142552-a7-anesthesia-system-fda-510k.jpg K142552 - A7 Anesthesia System K142552 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Jan 2015. https://www.510kdatabase.net/k143460/ 2015-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k143460-cannulated-screw-system-fda-510k.jpg K143460 - Cannulated Screw System K143460 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jan 2015. https://www.510kdatabase.net/k141599/ 2015-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k141599-divergence-anterior-cervical-fusion-fda-510k.jpg K141599 - DIVERGENCE ANTERIOR CERVICAL FUSION SYSTEM K141599 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Jan 2015. https://www.510kdatabase.net/k142749/ 2015-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k142749-truwave-disposable-pressure-transducer-fda-510k.jpg K142749 - TruWave Disposable Pressure Transducer K142749 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Jan 2015. https://www.510kdatabase.net/k141206/ 2015-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k141206-edwards-lifesciences-thruport-knotting-fda-510k.jpg K141206 - EDWARDS LIFESCIENCES THRUPORT KNOTTING SYSTEM K141206 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Jan 2015. https://www.510kdatabase.net/k142584/ 2015-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k142584-imar-fda-510k.jpg K142584 - iMAR K142584 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 2015. https://www.510kdatabase.net/k142922/ 2015-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k142922-spyglass-ds-direct-visualization-system-fda-510k.jpg K142922 - SpyGlass DS Direct Visualization System K142922 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Jan 2015. https://www.510kdatabase.net/k143139/ 2015-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k143139-arthrex-fracture-system-fda-510k.jpg K143139 - Arthrex Fracture System K143139 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jan 2015. https://www.510kdatabase.net/k143614/ 2015-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k143614-arthrex-low-profile-screws-fda-510k.jpg K143614 - Arthrex Low Profile Screws K143614 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jan 2015. https://www.510kdatabase.net/k143587/ 2015-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k143587-choice-guide-wire-mailman-guide-wire-fda-510k.jpg K143587 - ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix Wire K143587 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Jan 2015. https://www.510kdatabase.net/k143504/ 2015-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k143504-immulite-2000-albumin-calibration-fda-510k.jpg K143504 - IMMULITE 2000 Albumin Calibration Verification Material, IMMULITE 2000 Myoglobin Calibration Verification Material K143504 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Jan 2015. https://www.510kdatabase.net/k142948/ 2015-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k142948-biosure-regenesorb-interference-screw-fda-510k.jpg K142948 - BIOSURE REGENESORB interference Screw K142948 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jan 2015. https://www.510kdatabase.net/k143522/ 2015-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k143522-presto-inflation-device-fda-510k.jpg K143522 - Presto Inflation Device K143522 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 2015. https://www.510kdatabase.net/k133130/ 2015-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k133130-beacon-tip-torcon-nb-advantage-fda-510k.jpg K133130 - BEACON TIP TORCON NB ADVANTAGE CATHETER, TORCON NB ADVANTAGE CATHETER K133130 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Jan 2015. https://www.510kdatabase.net/k141783/ 2015-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k141783-tdx-sp2-power-wheechair-fda-510k.jpg K141783 - TDX SP2 POWER WHEECHAIR K141783 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Invacare Corporation. Cleared Jan 2015. https://www.510kdatabase.net/k142554/ 2015-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k142554-revolution-full-face-mask-fda-510k.jpg K142554 - Revolution Full Face Mask K142554 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Jan 2015. https://www.510kdatabase.net/k142635/ 2015-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k142635-medline-silicone-foley-catheter-fda-510k.jpg K142635 - Medline Silicone Foley Catheter K142635 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medline Industries, Inc.. Cleared Jan 2015. https://www.510kdatabase.net/k142034/ 2015-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k142034-3m-steri-vac-sterilizeraerator-fda-510k.jpg K142034 - 3M STERI-VAC STERILIZER/AERATOR K142034 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Jan 2015. https://www.510kdatabase.net/k143220/ 2015-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k143220-sidekick-ez-frame-external-fixation-fda-510k.jpg K143220 - SIDEKICK EZ FRAME External Fixation System K143220 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jan 2015. https://www.510kdatabase.net/k142840/ 2015-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k142840-unity-network-id-fda-510k.jpg K142840 - Unity Network ID K142840 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Healthcare. Cleared Jan 2015. https://www.510kdatabase.net/k143107/ 2015-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k143107-dlp-vein-graft-cannula-fda-510k.jpg K143107 - DLP Vein Graft Cannula K143107 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Jan 2015. https://www.510kdatabase.net/k143472/ 2015-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k143472-te7-diagnostic-ultrasound-system-fda-510k.jpg K143472 - TE7 Diagnostic Ultrasound System K143472 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Jan 2015. https://www.510kdatabase.net/k142429/ 2014-12-24 monthly 0.5 https://www.510kdatabase.net/og-image/k142429-codman-microcoil-delivery-system-fda-510k.jpg K142429 - CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2 Microcoil Delivery System, EnPower Control Cable, Connector Cable K142429 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Dec 2014. https://www.510kdatabase.net/k143352/ 2014-12-24 monthly 0.5 https://www.510kdatabase.net/og-image/k143352-immulite-2000-ferritin-calibration-fda-510k.jpg K143352 - IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3 Calibration Verification Material K143352 is a FDA 510(k) cleared immunology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Dec 2014. https://www.510kdatabase.net/k142933/ 2014-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k142933-biomet-tibial-trays-fda-510k.jpg K142933 - Biomet Tibial trays K142933 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Dec 2014. https://www.510kdatabase.net/k143376/ 2014-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k143376-adiva-centaur-progesterone-master-fda-510k.jpg K143376 - ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material K143376 is a FDA 510(k) cleared immunology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Dec 2014. https://www.510kdatabase.net/k142373/ 2014-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k142373-access-25oh-vitamin-d-total-for-use-on-fda-510k.jpg K142373 - Access 25(OH) Vitamin D Total for Use on the Access 2 Immuno. Syst., Access 25(OH) Vitamin D Total Calibrators for Use on the Access 2 Immuno. Syst K142373 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Dec 2014. https://www.510kdatabase.net/k142787/ 2014-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k142787-zimmer-persona-personalized-knee-system-fda-510k.jpg K142787 - Zimmer Persona Personalized Knee System K142787 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Dec 2014. https://www.510kdatabase.net/k142807/ 2014-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k142807-anthem-ps-total-knee-system-fda-510k.jpg K142807 - ANTHEM PS Total Knee System K142807 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Dec 2014. https://www.510kdatabase.net/k143429/ 2014-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k143429-passage-hemostasis-valve-fda-510k.jpg K143429 - Passage Hemostasis Valve K143429 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Dec 2014. https://www.510kdatabase.net/k142362/ 2014-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k142362-access-25oh-vitamin-d-total-for-use-on-fda-510k.jpg K142362 - Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno. Syst. Access 25(OH) Vitamin D Total Calibrators for Use on the UniCel Dxl Immuno. K142362 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Dec 2014. https://www.510kdatabase.net/k143224/ 2014-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k143224-truebeam-truebeam-stx-edge-fda-510k.jpg K143224 - TrueBeam-TrueBeam STx-Edge K143224 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Dec 2014. https://www.510kdatabase.net/k143342/ 2014-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k143342-elecsys-t-uptake-calset-fda-510k.jpg K143342 - Elecsys T-Uptake Calset K143342 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Dec 2014. https://www.510kdatabase.net/k140855/ 2014-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k140855-arthrex-suturetak-suture-anchors-fda-510k.jpg K140855 - ARTHREX SUTURETAK SUTURE ANCHORS K140855 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Dec 2014. https://www.510kdatabase.net/k141474/ 2014-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k141474-becton-dickinson-intelliport-system-fda-510k.jpg K141474 - BECTON DICKINSON INTELLIPORT SYSTEM K141474 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson & CO. Cleared Dec 2014. https://www.510kdatabase.net/k142049/ 2014-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k142049-multix-fusion-va30-va40-fda-510k.jpg K142049 - MULTIX FUSION VA30 & VA40 K142049 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Dec 2014. https://www.510kdatabase.net/k143009/ 2014-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k143009-echo-bi-metric-microplasty-hip-system-fda-510k.jpg K143009 - Echo Bi-Metric Microplasty Hip System K143009 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Dec 2014. https://www.510kdatabase.net/k143050/ 2014-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k143050-vlp-mini-mod-small-bone-plating-system-fda-510k.jpg K143050 - VLP Mini-Mod Small Bone Plating System 1.5mm Plates and Screws K143050 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Dec 2014. https://www.510kdatabase.net/k142051/ 2014-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k142051-prelude-plastic-jacketed-guide-wire-fda-510k.jpg K142051 - PRELUDE PLASTIC JACKETED GUIDE WIRE K142051 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Dec 2014. https://www.510kdatabase.net/k141295/ 2014-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k141295-merit-hydrophilic-guidewire-fda-510k.jpg K141295 - MERIT HYDROPHILIC GUIDEWIRE K141295 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Dec 2014. https://www.510kdatabase.net/k142108/ 2014-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k142108-rt-elements-dose-review-brain-fda-510k.jpg K142108 - RT ELEMENTS, DOSE REVIEW, BRAIN METASTASES, ADAPTIVE HYBRID SURGERY ANALYSIS K142108 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab AG. Cleared Dec 2014. https://www.510kdatabase.net/k143284/ 2014-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k143284-elecsys-estradiol-iii-calcheck-fda-510k.jpg K143284 - Elecsys Estradiol III Calcheck K143284 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Dec 2014. https://www.510kdatabase.net/k140593/ 2014-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k140593-advance-salivary-balloon-catheter-with-fda-510k.jpg K140593 - ADVANCE SALIVARY BALLOON CATHETER WITH WIRE GUIDE K140593 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cook, Inc.. Cleared Dec 2014. https://www.510kdatabase.net/k140669/ 2014-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k140669-g7-osseoti-acetublar-shells-fda-510k.jpg K140669 - G7 OSSEOTI ACETUBLAR SHELLS K140669 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Dec 2014. https://www.510kdatabase.net/k142560/ 2014-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k142560-varian-head-frame-fda-510k.jpg K142560 - Varian Head Frame K142560 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Dec 2014. https://www.510kdatabase.net/k142683/ 2014-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k142683-12-mm-endoscopes-and-accessories-fda-510k.jpg K142683 - 12 mm Endoscopes and Accessories K142683 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Dec 2014. https://www.510kdatabase.net/k143254/ 2014-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k143254-esie-apps-suite-fda-510k.jpg K143254 - eSie Apps Suite K143254 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Dec 2014. https://www.510kdatabase.net/k143208/ 2014-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k143208-denali-filter-system-femoral-delivery-fda-510k.jpg K143208 - Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavain Delivery Kit K143208 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 2014. https://www.510kdatabase.net/k140838/ 2014-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k140838-iv-administration-set-with-hand-pump-fda-510k.jpg K140838 - IV ADMINISTRATION SET WITH HAND PUMP K140838 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Dec 2014. https://www.510kdatabase.net/k142758/ 2014-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k142758-advia-centaur-hav-total-assay-fda-510k.jpg K142758 - ADVIA Centaur HAV total assay K142758 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Dec 2014. https://www.510kdatabase.net/k143025/ 2014-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k143025-total-compression-plating-system-fda-510k.jpg K143025 - TOTAL COMPRESSION PLATING SYSTEM K143025 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Dec 2014. https://www.510kdatabase.net/k143194/ 2014-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k143194-adiva-centaur-prolactin-master-curve-fda-510k.jpg K143194 - ADIVA Centaur Prolactin Master Curve Material (MCM), ADIVA Centaur Cortisol Master Curve Material (MCM) K143194 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Dec 2014. https://www.510kdatabase.net/k141632/ 2014-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k141632-zevo-tm-anterior-cervical-plate-system-fda-510k.jpg K141632 - ZEVO (TM) ANTERIOR CERVICAL PLATE SYSTEM K141632 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Dec 2014. https://www.510kdatabase.net/k140920/ 2014-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k140920-syngoct-colonography-fda-510k.jpg K140920 - SYNGO.CT COLONOGRAPHY K140920 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Dec 2014. https://www.510kdatabase.net/k143217/ 2014-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k143217-12-mm-stapler-bladeless-obturators-fda-510k.jpg K143217 - 12 mm & Stapler Bladeless Obturators K143217 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Dec 2014. https://www.510kdatabase.net/k142591/ 2014-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k142591-cd-horizon-spinal-system-fda-510k.jpg K142591 - CD HORIZON Spinal System K142591 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Dec 2014. https://www.510kdatabase.net/k142973/ 2014-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k142973-resolution-clip-fda-510k.jpg K142973 - Resolution Clip K142973 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Dec 2014. https://www.510kdatabase.net/k143141/ 2014-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k143141-cd-horizon-spinal-system-fda-510k.jpg K143141 - CD HORIZON Spinal System K143141 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Dec 2014. https://www.510kdatabase.net/k143066/ 2014-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k143066-zimmer-plates-and-screws-zps-non-fda-510k.jpg K143066 - Zimmer Plates and Screws (ZPS) - Non Sterile Plate Line Extensions, Sterile/Non-Sterile ZPS / Screws and Washers K143066 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Nov 2014. https://www.510kdatabase.net/k140842/ 2014-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k140842-dimension-loci-free-thyroxine-flex-fda-510k.jpg K140842 - DIMENSION LOCI FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4L, DIMENSION LOCI THYROID STIMULATING HORMONE FLEX REAGENT CART K140842 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Nov 2014. https://www.510kdatabase.net/k140859/ 2014-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k140859-dimension-vista-free-thyroxine-flex-fda-510k.jpg K140859 - DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE, FT4, DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT K140859 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Nov 2014. https://www.510kdatabase.net/k141408/ 2014-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k141408-resolve-biliary-locking-drainage-fda-510k.jpg K141408 - RESOLVE BILIARY LOCKING DRAINAGE CATHETER K141408 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Nov 2014. https://www.510kdatabase.net/k140382/ 2014-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k140382-aeromini-tracheobronchial-stent-fda-510k.jpg K140382 - AEROMINI TRACHEOBRONCHIAL STENT TECHNOLOGY K140382 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Nov 2014. https://www.510kdatabase.net/k142863/ 2014-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k142863-univers-rivers-shoulder-prosthesis-fda-510k.jpg K142863 - Univers Rivers Shoulder Prosthesis System K142863 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Nov 2014. https://www.510kdatabase.net/k142434/ 2014-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k142434-artiste-solution-sysvc10c-phase-2-fda-510k.jpg K142434 - ARTISTE SOLUTION, SYS_VC10C, PHASE 2 UPDATE WITH THE SYNGO RT THERAPIST & RT ONCOLOGIST WORKSPACES, V4.3.1_MR1 K142434 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2014. https://www.510kdatabase.net/k142520/ 2014-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k142520-smith-nephew-inc-spatialframecom-v50-fda-510k.jpg K142520 - Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based software K142520 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Nov 2014. https://www.510kdatabase.net/k142585/ 2014-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k142585-phalinx-hammertoe-system-fda-510k.jpg K142585 - PhaLinx Hammertoe System K142585 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Nov 2014. https://www.510kdatabase.net/k141977/ 2014-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k141977-magnetom-aera-with-software-syngo-mr-fda-510k.jpg K141977 - MAGNETOM AERA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH 24 RF CHANNEL K141977 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2014. https://www.510kdatabase.net/k143047/ 2014-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k143047-arthrex-ibalance-patella-implant-dome-fda-510k.jpg K143047 - Arthrex iBalance Patella Implant, Dome K143047 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Nov 2014. https://www.510kdatabase.net/k140085/ 2014-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k140085-universa-percultaneous-drainage-catheter-fda-510k.jpg K140085 - UNIVERSA PERCULTANEOUS DRAINAGE CATHETER K140085 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook Incorporated. Cleared Nov 2014. https://www.510kdatabase.net/k142673/ 2014-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k142673-bio-medicus-adult-cannulae-and-fda-510k.jpg K142673 - Bio-Medicus Adult Cannulae and Introducer K142673 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Nov 2014. https://www.510kdatabase.net/k140424/ 2014-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k140424-respironics-reusable-heated-tubing-fda-510k.jpg K140424 - RESPIRONICS REUSABLE HEATED TUBING K140424 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Nov 2014. https://www.510kdatabase.net/k141471/ 2014-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k141471-journey-ii-xr-knee-system-fda-510k.jpg K141471 - JOURNEY II XR KNEE SYSTEM K141471 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Nov 2014. https://www.510kdatabase.net/k142315/ 2014-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k142315-minop-disposable-introducer-26f-fda-510k.jpg K142315 - MINOP Disposable Introducer 26F K142315 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Nov 2014. https://www.510kdatabase.net/k142265/ 2014-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k142265-one-snare-endovascular-microsnare-system-fda-510k.jpg K142265 - ONE Snare Endovascular Microsnare System K142265 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Nov 2014. https://www.510kdatabase.net/k142836/ 2014-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k142836-zimmer-plates-and-screws-zps-forte-fda-510k.jpg K142836 - Zimmer Plates and Screws (ZPS), Forte Screws K142836 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Nov 2014. https://www.510kdatabase.net/k142575/ 2014-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k142575-bard-ritecath-intermittent-urinary-fda-510k.jpg K142575 - Bard RiteCath Intermittent Urinary Catheter K142575 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 2014. https://www.510kdatabase.net/k142443/ 2014-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k142443-site-rite-6-ultrasound-system-with-fda-510k.jpg K142443 - Site-Rite 6 Ultrasound System with Pinpoint GT Technology K142443 is a FDA 510(k) cleared radiology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 2014. https://www.510kdatabase.net/k142878/ 2014-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k142878-immulite-2000-beta-2-microglobulin-fda-510k.jpg K142878 - IMMULITE 2000 Beta-2 Microglobulin Calibration Verification Material, IMMULITE 2000 High Sensitivity CRP Calibration Verification Material K142878 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Oct 2014. https://www.510kdatabase.net/k142811/ 2014-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k142811-immulite-2000-lh-calibration-fda-510k.jpg K142811 - IMMULITE 2000 LH Calibration Verification Material (CVM), IMMULITE 2000 Free T3 Calibration Verification Material (CVM), IMMULITE 2000 Gastrin Calibration Verification Material (CVM) K142811 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Oct 2014. https://www.510kdatabase.net/k142864/ 2014-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k142864-advia-centaur-c-peptide-cps-master-fda-510k.jpg K142864 - ADVIA Centaur C-peptide (CpS) Master Curve Material (MCM), ADVIA Centaur Insulin (IRI) Master Curve Material (MCM) K142864 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Oct 2014. https://www.510kdatabase.net/k141331/ 2014-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k141331-biomet-orthopaedic-salvage-system-oss-fda-510k.jpg K141331 - BIOMET ORTHOPAEDIC SALVAGE SYSTEM (OSS) K141331 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Oct 2014. https://www.510kdatabase.net/k141407/ 2014-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k141407-vanguard-xp-femoral-componentgen-fda-510k.jpg K141407 - VANGUARD XP FEMORAL COMPONENT(GEN II)/VANGUARD XP FEMORAL TRIAL K141407 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Oct 2014. https://www.510kdatabase.net/k141714/ 2014-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k141714-pro-toe-x-flex-hammertoe-fixation-system-fda-510k.jpg K141714 - PRO-TOE X-FLEX HAMMERTOE FIXATION SYSTEM K141714 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Oct 2014. https://www.510kdatabase.net/k142133/ 2014-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k142133-elecys-cmv-igm-immunoassay-fda-510k.jpg K142133 - ELECYS CMV IGM IMMUNOASSAY K142133 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Diagnostics. Cleared Oct 2014. https://www.510kdatabase.net/k142784/ 2014-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k142784-affinity-fusion-oxygenator-with-fda-510k.jpg K142784 - Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface K142784 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Oct 2014. https://www.510kdatabase.net/k133157/ 2014-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k133157-tri-optic-measurement-cell-fda-510k.jpg K133157 - TRI-OPTIC MEASUREMENT CELL K133157 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Oct 2014. https://www.510kdatabase.net/k141560/ 2014-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k141560-ethicon-physiomesh-open-flexible-fda-510k.jpg K141560 - ETHICON PHYSIOMESH OPEN FLEXIBLE COMPOSITE MESH DEVICE K141560 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Oct 2014. https://www.510kdatabase.net/k142556/ 2014-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k142556-flexible-video-uretero-choledochoscope-fda-510k.jpg K142556 - Flexible Video-Uretero-Choledochoscope System K142556 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Oct 2014. https://www.510kdatabase.net/k142876/ 2014-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k142876-acuson-s1000-s2000-s3000-diagnostic-fda-510k.jpg K142876 - ACUSON S1000/ S2000/ S3000 Diagnostic Ultrasound Systems K142876 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 2014. https://www.510kdatabase.net/k142281/ 2014-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k142281-zimmer-mdn-intramedullary-fixation-fda-510k.jpg K142281 - ZIMMER M/DN INTRAMEDULLARY FIXATION SYSTEM K142281 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Oct 2014. https://www.510kdatabase.net/k142579/ 2014-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k142579-zimmer-periarticular-plating-system-fda-510k.jpg K142579 - Zimmer Periarticular Plating System K142579 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Oct 2014. https://www.510kdatabase.net/k142602/ 2014-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k142602-valor-hindfoot-fusion-nail-system-fda-510k.jpg K142602 - VALOR Hindfoot Fusion Nail System K142602 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Oct 2014. https://www.510kdatabase.net/k141604/ 2014-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k141604-cd-horizon-spinal-system-fda-510k.jpg K141604 - CD HORIZON SPINAL SYSTEM K141604 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Oct 2014. https://www.510kdatabase.net/k141820/ 2014-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k141820-jagwire-high-performance-guidwire-fda-510k.jpg K141820 - JAGWIRE HIGH PERFORMANCE GUIDWIRE K141820 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Oct 2014. https://www.510kdatabase.net/k140268/ 2014-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k140268-simple-t-youth-nasal-mask-fda-510k.jpg K140268 - SIMPLE T YOUTH NASAL MASK K140268 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Oct 2014. https://www.510kdatabase.net/k141335/ 2014-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k141335-expel-apd-drainage-catheter-system-fda-510k.jpg K141335 - EXPEL APD DRAINAGE CATHETER SYSTEM K141335 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Oct 2014. https://www.510kdatabase.net/k141344/ 2014-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k141344-expel-nephroureteral-drainage-stent-fda-510k.jpg K141344 - EXPEL NEPHROURETERAL DRAINAGE STENT WITH TWIST-LOC HUB SYSTEM, EXPEL URETERAL DRAINAGE STENT SYSTEM K141344 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Oct 2014. https://www.510kdatabase.net/k141426/ 2014-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k141426-elecsys-folate-iii-fda-510k.jpg K141426 - ELECSYS FOLATE III K141426 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Oct 2014. https://www.510kdatabase.net/k142267/ 2014-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k142267-sherlock-3cg-tip-positioning-system-fda-510k.jpg K142267 - Sherlock 3CG Tip Positioning System Stylet K142267 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 2014. https://www.510kdatabase.net/k142636/ 2014-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k142636-merit-10ml-syringe-fda-510k.jpg K142636 - Merit 10mL Syringe K142636 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Oct 2014. https://www.510kdatabase.net/k133677/ 2014-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k133677-syngo-ct-single-source-dual-energy-fda-510k.jpg K133677 - SYNGO CT SINGLE SOURCE DUAL ENERGY K133677 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 2014. https://www.510kdatabase.net/k140543/ 2014-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k140543-preludeease-hydrophilic-sheath-fda-510k.jpg K140543 - PRELUDEEASE HYDROPHILIC SHEATH INTRODUCER K140543 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Oct 2014. https://www.510kdatabase.net/k141584/ 2014-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k141584-ultraflex-tracheobronchial-covered-fda-510k.jpg K141584 - ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT SYSTEM K141584 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Boston Scientific Corporation. Cleared Oct 2014. https://www.510kdatabase.net/k141776/ 2014-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k141776-stratafix-symmetric-pds-plus-knotless-fda-510k.jpg K141776 - STRATAFIX SYMMETRIC PDS PLUS KNOTLESS TISSUE CONTROL DEVICES K141776 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Oct 2014. https://www.510kdatabase.net/k142160/ 2014-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k142160-logiq-e9-diagnostic-ultrasound-system-fda-510k.jpg K142160 - LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM K142160 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Oct 2014. https://www.510kdatabase.net/k132592/ 2014-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k132592-flexor-radial-hydrophilic-introducer-fda-510k.jpg K132592 - FLEXOR RADIAL HYDROPHILIC INTRODUCER ACCESS SET K132592 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Oct 2014. https://www.510kdatabase.net/k141378/ 2014-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k141378-idc-interlocking-detachable-coil-fda-510k.jpg K141378 - IDC INTERLOCKING DETACHABLE COIL K141378 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Oct 2014. https://www.510kdatabase.net/k142515/ 2014-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k142515-magnetom-combi-suite-neurosurgery-for-fda-510k.jpg K142515 - MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Aera, MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Skyra K142515 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 2014. https://www.510kdatabase.net/k141704/ 2014-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k141704-novashield-injectable-nasal-packing-fda-510k.jpg K141704 - NOVASHIELD INJECTABLE NASAL PACKING AND STENT K141704 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Medtronic, Inc.. Cleared Oct 2014. https://www.510kdatabase.net/k142442/ 2014-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k142442-magna-fx-and-mini-magna-fx-cannulated-fda-510k.jpg K142442 - MAGNA-FX AND MINI MAGNA-FX CANNULATED SCREW FIXATION SYSTEM K142442 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Oct 2014. https://www.510kdatabase.net/k142268/ 2014-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k142268-varian-verification-system-vvs-fda-510k.jpg K142268 - Varian Verification System (VVS) K142268 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Oct 2014. https://www.510kdatabase.net/k142450/ 2014-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k142450-divergence-anterior-cervical-fusion-fda-510k.jpg K142450 - DIVERGENCE Anterior Cervical Fusion System K142450 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Oct 2014. https://www.510kdatabase.net/k133577/ 2014-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k133577-clydesdaler-spinal-system-fda-510k.jpg K133577 - CLYDESDALE(R) SPINAL SYSTEM K133577 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Sep 2014. https://www.510kdatabase.net/k140369/ 2014-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k140369-medline-neuro-sponge-fda-510k.jpg K140369 - MEDLINE NEURO SPONGE K140369 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medline Industries, Inc.. Cleared Sep 2014. https://www.510kdatabase.net/k141490/ 2014-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k141490-universal-segmented-cylinder-fda-510k.jpg K141490 - UNIVERSAL SEGMENTED CYLINDER APPLICATOR SET AND UNIVERSAL STUMP APPLICATOR SET K141490 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Sep 2014. https://www.510kdatabase.net/k141150/ 2014-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k141150-pta-balloon-dilatation-catheter-fda-510k.jpg K141150 - PTA BALLOON DILATATION CATHETER K141150 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Sep 2014. https://www.510kdatabase.net/k133456/ 2014-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k133456-power-trialysis-short-term-dialysis-fda-510k.jpg K133456 - POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETER K133456 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Sep 2014. https://www.510kdatabase.net/k133223/ 2014-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k133223-xenmatrix-ab-surgical-graft-fda-510k.jpg K133223 - XENMATRIX AB SURGICAL GRAFT K133223 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Sep 2014. https://www.510kdatabase.net/k141472/ 2014-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k141472-vantage-elan-fda-510k.jpg K141472 - VANTAGE ELAN K141472 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Sep 2014. https://www.510kdatabase.net/k141697/ 2014-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k141697-xtrafix-external-fixation-system-fda-510k.jpg K141697 - XTRAFIX EXTERNAL FIXATION SYSTEM, XTRAFIX SMALL EXTERNAL FIXATION SYSTEM K141697 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Sep 2014. https://www.510kdatabase.net/k141985/ 2014-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k141985-true-ba-v-balloon-valvuloplasty-catheter-fda-510k.jpg K141985 - TRUE BA V BALLOON VALVULOPLASTY CATHETER K141985 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Sep 2014. https://www.510kdatabase.net/k123329/ 2014-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k123329-da-vinvi-surgical-system-fda-510k.jpg K123329 - DA VINVI SURGICAL SYSTEM K123329 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Sep 2014. https://www.510kdatabase.net/k140496/ 2014-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k140496-access-vitamin-b12-assay-access-fda-510k.jpg K140496 - Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System Reagents K140496 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Sep 2014. https://www.510kdatabase.net/k140912/ 2014-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k140912-somatom-scopesomatom-scope-power-fda-510k.jpg K140912 - SOMATOM SCOPE/SOMATOM SCOPE POWER K140912 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 2014. https://www.510kdatabase.net/k142295/ 2014-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k142295-sirius-femoral-stem-size-30a-fda-510k.jpg K142295 - Sirius Femoral Stem, Size 30A K142295 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Sep 2014. https://www.510kdatabase.net/k140608/ 2014-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k140608-merit-heparin-coated-inqwire-fda-510k.jpg K140608 - MERIT HEPARIN-COATED INQWIRE DIAGNOSTIC GUIDEWIRE K140608 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Sep 2014. https://www.510kdatabase.net/k141971/ 2014-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k141971-biograph-true-petct-family-software-fda-510k.jpg K141971 - BIOGRAPH TRUE PET/CT FAMILY SOFTWARE K141971 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 2014. https://www.510kdatabase.net/k142259/ 2014-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k142259-direxion-torqueable-microcatheter-fda-510k.jpg K142259 - Direxion Torqueable Microcatheter K142259 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Sep 2014. https://www.510kdatabase.net/k142395/ 2014-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k142395-sc2000-and-acuson-x300-diagnostic-fda-510k.jpg K142395 - SC2000 and ACUSON X300 Diagnostic Ultrasound Systems K142395 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 2014. https://www.510kdatabase.net/k140528/ 2014-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k140528-true-beam-true-beam-stx-edge-fda-510k.jpg K140528 - TRUE BEAM, TRUE BEAM STX, EDGE K140528 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Sep 2014. https://www.510kdatabase.net/k140911/ 2014-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k140911-unicel-dxh-800-coulter-cellular-fda-510k.jpg K140911 - UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM/ UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM K140911 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Sep 2014. https://www.510kdatabase.net/k141248/ 2014-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k141248-smart-segmentation-knowledge-based-fda-510k.jpg K141248 - SMART SEGMENTATION KNOWLEDGE BASED CONTOURING K141248 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Sep 2014. https://www.510kdatabase.net/k141574/ 2014-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k141574-artis-zeezeego-sw-vc21-fda-510k.jpg K141574 - ARTIS ZEE/ZEEGO SW VC21 K141574 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 2014. https://www.510kdatabase.net/k142127/ 2014-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k142127-elecsys-estradiol-iii-calcheck-5-fda-510k.jpg K142127 - ELECSYS ESTRADIOL III CALCHECK 5 K142127 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Sep 2014. https://www.510kdatabase.net/k140964/ 2014-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k140964-calculase-ii-fda-510k.jpg K140964 - CALCULASE II K140964 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Sep 2014. https://www.510kdatabase.net/k141495/ 2014-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k141495-truwave-disposable-pressure-transducer-fda-510k.jpg K141495 - TRUWAVE DISPOSABLE PRESSURE TRANSDUCER K141495 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Sep 2014. https://www.510kdatabase.net/k141635/ 2014-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k141635-arthrex-ibalance-tka-system-fda-510k.jpg K141635 - ARTHREX IBALANCE TKA SYSTEM K141635 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Sep 2014. https://www.510kdatabase.net/k141840/ 2014-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k141840-trabecular-metal-tibial-cone-broach-fda-510k.jpg K141840 - TRABECULAR METAL TIBIAL CONE BROACH, TRABECULAR METAL COUPLED TIBIAL CONE BROACH K141840 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Sep 2014. https://www.510kdatabase.net/k140690/ 2014-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k140690-bs-480-chemistry-analyzer-bs-490-fda-510k.jpg K140690 - BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER K140690 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Sep 2014. https://www.510kdatabase.net/k133741/ 2014-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k133741-accu-chek-performa-blood-glucose-fda-510k.jpg K133741 - ACCU-CHEK Performa Blood Glucose Monitoring System K133741 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Aug 2014. https://www.510kdatabase.net/k141821/ 2014-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k141821-alteon-neck-preserving-femoral-stem-fda-510k.jpg K141821 - ALTEON NECK PRESERVING FEMORAL STEM, STANDARD OFFSET, SIZE 6-7 K141821 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Aug 2014. https://www.510kdatabase.net/k142166/ 2014-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k142166-total-shield-surgical-fda-510k.jpg K142166 - TOTAL SHIELD SURGICAL K142166 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zimmer, Inc.. Cleared Aug 2014. https://www.510kdatabase.net/k141762/ 2014-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k141762-perfuse-percutaneous-decompression-fda-510k.jpg K141762 - PERFUSE PERCUTANEOUS DECOMPRESSION SYSTEM K141762 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Biomet, Inc.. Cleared Aug 2014. https://www.510kdatabase.net/k133678/ 2014-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k133678-confirm-bioactive-fda-510k.jpg K133678 - CONFIRM BIOACTIVE K133678 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Aug 2014. https://www.510kdatabase.net/k142036/ 2014-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k142036-infusomat-space-volumetric-infusion-fda-510k.jpg K142036 - INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP ADMINISTRATION SETS K142036 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Aug 2014. https://www.510kdatabase.net/k141597/ 2014-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k141597-mustang-balloon-dialation-catheter-fda-510k.jpg K141597 - MUSTANG BALLOON DIALATION CATHETER K141597 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Aug 2014. https://www.510kdatabase.net/k141127/ 2014-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k141127-medline-anti-embolism-stocking-fda-510k.jpg K141127 - MEDLINE ANTI-EMBOLISM STOCKING K141127 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Aug 2014. https://www.510kdatabase.net/k141521/ 2014-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k141521-mustang-balloon-dilatation-fda-510k.jpg K141521 - MUSTANG BALLOON DILATATION CATHETER/CHARGER PTA BALLOON DILATATION CATHETER K141521 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Aug 2014. https://www.510kdatabase.net/k141585/ 2014-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k141585-smith-nephew-disposable-fin-punch-fda-510k.jpg K141585 - SMITH & NEPHEW DISPOSABLE FIN PUNCH K141585 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Aug 2014. https://www.510kdatabase.net/k142006/ 2014-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k142006-symbia-60-fda-510k.jpg K142006 - SYMBIA 6.0 K142006 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 2014. https://www.510kdatabase.net/k142121/ 2014-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k142121-valor-hindfoot-fusion-nail-system-fda-510k.jpg K142121 - VALOR HINDFOOT FUSION NAIL SYSTEM K142121 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Aug 2014. https://www.510kdatabase.net/k133952/ 2014-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k133952-vitek-2-ast-ys-flucytosine-vitek-2-ast-fda-510k.jpg K133952 - VITEK 2 AST YS FLUCYTOSINE, VITEK 2 AST YEAST FLUCYTOSINE K133952 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Aug 2014. https://www.510kdatabase.net/k141772/ 2014-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k141772-immulte-2000-rubella-quantitative-igg-fda-510k.jpg K141772 - IMMULTE 2000 RUBELLA QUANTITATIVE IGG CALIBRATION VERIFICATION MATERIAL K141772 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Aug 2014. https://www.510kdatabase.net/k141653/ 2014-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k141653-biolox-delta-ceramic-option-heads-fda-510k.jpg K141653 - BIOLOX DELTA CERAMIC OPTION HEADS K141653 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Aug 2014. https://www.510kdatabase.net/k141090/ 2014-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k141090-nc-euphora-rapid-exchange-balloon-fda-510k.jpg K141090 - NC EUPHORA RAPID EXCHANGE BALLOON DILATATION CATHETER K141090 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Aug 2014. https://www.510kdatabase.net/k141129/ 2014-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k141129-exactech-cervical-spacer-system-fda-510k.jpg K141129 - EXACTECH CERVICAL SPACER SYSTEM K141129 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Aug 2014. https://www.510kdatabase.net/k141735/ 2014-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k141735-arthrex-ankle-fusion-plating-system-fda-510k.jpg K141735 - ARTHREX ANKLE FUSION PLATING SYSTEM K141735 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Aug 2014. https://www.510kdatabase.net/k141951/ 2014-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k141951-dlp-silicone-coronary-artery-ostial-fda-510k.jpg K141951 - DLP SILICONE CORONARY ARTERY OSTIAL CANNULAE K141951 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Aug 2014. https://www.510kdatabase.net/k140232/ 2014-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k140232-syngo-ct-2014a-somaris5-vb42-for-fda-510k.jpg K140232 - SYNGO CT 2014A (SOMARIS/5 VB42) FOR SOMATOM EMOTION & SENSATION FAMILY CT K140232 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 2014. https://www.510kdatabase.net/k140508/ 2014-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k140508-zimmer-plates-and-screws-systemzps-non-fda-510k.jpg K140508 - ZIMMER PLATES AND SCREWS SYSTEM(ZPS)- NON-STERILE PLATES AND SCREWS K140508 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Aug 2014. https://www.510kdatabase.net/k140392/ 2014-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k140392-3m-attest-rapid-readout-biological-fda-510k.jpg K140392 - 3M ATTEST RAPID READOUT BIOLOGICAL INDICATOR / 3M ATTEST AUTO-READER K140392 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Aug 2014. https://www.510kdatabase.net/k140476/ 2014-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k140476-arthrex-fibertak-suture-anchor-fda-510k.jpg K140476 - ARTHREX FIBERTAK SUTURE ANCHOR K140476 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Aug 2014. https://www.510kdatabase.net/k141517/ 2014-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k141517-zimmer-plates-and-screws-zps-non-fda-510k.jpg K141517 - ZIMMER PLATES AND SCREWS (ZPS)-NON-STERILE PLATES K141517 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Aug 2014. https://www.510kdatabase.net/k141734/ 2014-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k141734-zimmer-periarticular-locking-system-fda-510k.jpg K141734 - ZIMMER PERIARTICULAR LOCKING SYSTEM K141734 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Aug 2014. https://www.510kdatabase.net/k141077/ 2014-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k141077-da-vinci-firefly-imaging-system-fda-510k.jpg K141077 - DA VINCI FIREFLY IMAGING SYSTEM K141077 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Aug 2014. https://www.510kdatabase.net/k142021/ 2014-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k142021-elecsys-estradiol-iii-calset-fda-510k.jpg K142021 - Elecsys Estradiol III CalSet K142021 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Aug 2014. https://www.510kdatabase.net/k141236/ 2014-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k141236-nc-emerge-ptca-dilatation-catheter-fda-510k.jpg K141236 - NC EMERGE PTCA DILATATION CATHETER (MONORAIL), NC EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) K141236 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Aug 2014. https://www.510kdatabase.net/k141283/ 2014-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k141283-eclipse-treatment-planning-system-fda-510k.jpg K141283 - ECLIPSE TREATMENT PLANNING SYSTEM K141283 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Aug 2014. https://www.510kdatabase.net/k141846/ 2014-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k141846-acuson-x700-ultrasound-system-acuson-fda-510k.jpg K141846 - ACUSON X700 ULTRASOUND SYSTEM, ACUSON X600 ULTRASOUND SYSTEM K141846 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 2014. https://www.510kdatabase.net/k141336/ 2014-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k141336-source-guide-tube-with-locking-fda-510k.jpg K141336 - SOURCE GUIDE TUBE WITH LOCKING MECHANISM FOR 113 MM NEEDLES, GAMMAMEDPLUS K141336 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Aug 2014. https://www.510kdatabase.net/k141494/ 2014-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k141494-cd-horizon-spinal-system-fda-510k.jpg K141494 - CD HORIZON SPINAL SYSTEM K141494 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Aug 2014. https://www.510kdatabase.net/k133817/ 2014-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k133817-vitek-2-ast-yeast-fluconazole-fda-510k.jpg K133817 - VITEK 2 AST - YEAST FLUCONAZOLE K133817 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Aug 2014. https://www.510kdatabase.net/k141746/ 2014-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k141746-as20-composite-graft-fda-510k.jpg K141746 - AS20 COMPOSITE GRAFT K141746 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Aug 2014. https://www.510kdatabase.net/k141768/ 2014-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k141768-logiq-v5logiq-v3-fda-510k.jpg K141768 - LOGIQ V5/LOGIQ V3 K141768 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Aug 2014. https://www.510kdatabase.net/k140302/ 2014-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k140302-optetrak-logic-porous-femoral-components-fda-510k.jpg K140302 - OPTETRAK LOGIC POROUS FEMORAL COMPONENTS K140302 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Jul 2014. https://www.510kdatabase.net/k140883/ 2014-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k140883-vanguard-360-osseoti-tibial-sleeve-fda-510k.jpg K140883 - VANGUARD 360 OSSEOTI TIBIAL SLEEVE AUGMENT K140883 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jul 2014. https://www.510kdatabase.net/k141011/ 2014-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k141011-g-force-gen-2-suture-anchor-system-fda-510k.jpg K141011 - G-FORCE GEN 2 SUTURE ANCHOR SYSTEM K141011 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jul 2014. https://www.510kdatabase.net/k141797/ 2014-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k141797-alteon-65mm-bone-screws-fda-510k.jpg K141797 - ALTEON 6.5MM BONE SCREWS K141797 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Jul 2014. https://www.510kdatabase.net/k140494/ 2014-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k140494-v-pro-sterilization-tray-sterilization-fda-510k.jpg K140494 - V-PRO STERILIZATION TRAY/ STERILIZATION MAT K140494 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Jul 2014. https://www.510kdatabase.net/k140553/ 2014-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k140553-endowrist-stapler-45-and-stapler-45-fda-510k.jpg K140553 - ENDOWRIST STAPLER 45 AND STAPLER 45 RELOADS K140553 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Jul 2014. https://www.510kdatabase.net/k141675/ 2014-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k141675-voluson-p6-voluson-p8-fda-510k.jpg K141675 - VOLUSON P6, VOLUSON P8 K141675 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Jul 2014. https://www.510kdatabase.net/k133156/ 2014-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k133156-advia-centaur-vitamin-d-total-vitd-assay-fda-510k.jpg K133156 - ADVIA CENTAUR VITAMIN D TOTAL (VITD) ASSAY K133156 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Jul 2014. https://www.510kdatabase.net/k140498/ 2014-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k140498-v-pro-60-low-temperature-sterilization-fda-510k.jpg K140498 - V-PRO 60 LOW TEMPERATURE STERILIZATION SYSTEM K140498 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Jul 2014. https://www.510kdatabase.net/k140273/ 2014-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k140273-equalizer-occlusion-balloon-catheter-fda-510k.jpg K140273 - EQUALIZER OCCLUSION BALLOON CATHETER K140273 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Jul 2014. https://www.510kdatabase.net/k140487/ 2014-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k140487-vis-u-all-low-temperature-fda-510k.jpg K140487 - VIS-U-ALL LOW TEMPERATURE STERILIZATION POUCH/TUBING K140487 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Jul 2014. https://www.510kdatabase.net/k134031/ 2014-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k134031-threader-monorail-micro-dilatation-fda-510k.jpg K134031 - THREADER MONORAIL MICRO-DILATATION CATHETER, THREADER OVER-THE-WIRE MICRO-DILATATION CATHETER K134031 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Jul 2014. https://www.510kdatabase.net/k140726/ 2014-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k140726-captivator-emr-device-for-standard-fda-510k.jpg K140726 - CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 1, CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 5, CAPTIV K140726 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Jul 2014. https://www.510kdatabase.net/k140879/ 2014-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k140879-biosure-healicoil-pk-interference-screw-fda-510k.jpg K140879 - BIOSURE HEALICOIL PK INTERFERENCE SCREW K140879 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 2014. https://www.510kdatabase.net/k140897/ 2014-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k140897-syngomr-neurology-syngommr-general-fda-510k.jpg K140897 - SYNGO.MR NEUROLOGY, SYNGO.MMR GENERAL K140897 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 2014. https://www.510kdatabase.net/k141577/ 2014-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k141577-arthrex-pip-dart-fda-510k.jpg K141577 - ARTHREX PIP DART K141577 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jul 2014. https://www.510kdatabase.net/k141639/ 2014-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k141639-voluson-s6-voluson-s8-fda-510k.jpg K141639 - VOLUSON S6, VOLUSON S8 K141639 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Jul 2014. https://www.510kdatabase.net/k140499/ 2014-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k140499-verify-v24-self-contained-biological-fda-510k.jpg K140499 - VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED VH202 STERILIZATION PROCESSES K140499 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Jul 2014. https://www.510kdatabase.net/k140515/ 2014-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k140515-verify-hpu-chemical-indicator-verify-fda-510k.jpg K140515 - VERIFY HPU CHEMICAL INDICATOR/ VERIFY VAPORIZED VH202 PROCESS INDICATOR ADHESIVE LABEL K140515 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Jul 2014. https://www.510kdatabase.net/k140750/ 2014-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k140750-shilla-growth-guidance-system-fda-510k.jpg K140750 - SHILLA GROWTH GUIDANCE SYSTEM K140750 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Jul 2014. https://www.510kdatabase.net/k141143/ 2014-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k141143-cobas-c-tina-quant-cystatin-c-gen2-fda-510k.jpg K141143 - COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTATIN C GEN.2 CONTROL SET K141143 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Jul 2014. https://www.510kdatabase.net/k133890/ 2014-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k133890-aesculap-optilene-nonabsorbable-suture-fda-510k.jpg K133890 - AESCULAP OPTILENE NONABSORBABLE SUTURE K133890 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Jul 2014. https://www.510kdatabase.net/k140829/ 2014-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k140829-unicel-dxc-synchron-systems-hemoglobin-fda-510k.jpg K140829 - UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN A1C3 (HBA1C3) REAGENT K140829 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jul 2014. https://www.510kdatabase.net/k141605/ 2014-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k141605-cd-horizon-spinal-system-fda-510k.jpg K141605 - CD HORIZON SPINAL SYSTEM K141605 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Jul 2014. https://www.510kdatabase.net/k141554/ 2014-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k141554-esie-apps-suite-fda-510k.jpg K141554 - ESIE APPS SUITE K141554 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 2014. https://www.510kdatabase.net/k140513/ 2014-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k140513-merit-safety-introducer-needle-fda-510k.jpg K140513 - MERIT SAFETY INTRODUCER NEEDLE K140513 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jul 2014. https://www.510kdatabase.net/k140531/ 2014-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k140531-biofoam-bone-wedge-fda-510k.jpg K140531 - BIOFOAM BONE WEDGE K140531 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jul 2014. https://www.510kdatabase.net/k141417/ 2014-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k141417-charlotte-tm-mtp-bone-fusion-plate-fda-510k.jpg K141417 - CHARLOTTE (TM) MTP BONE FUSION PLATE SYSTEM HEX SCREW K141417 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jul 2014. https://www.510kdatabase.net/k141444/ 2014-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k141444-immulite-2000-fda-510k.jpg K141444 - IMMULITE 2000 K141444 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Jul 2014. https://www.510kdatabase.net/k141478/ 2014-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k141478-arthrex-fracture-plates-and-screws-fda-510k.jpg K141478 - ARTHREX FRACTURE PLATES AND SCREWS K141478 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jul 2014. https://www.510kdatabase.net/k133648/ 2014-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k133648-syngo-ct-dual-energy-fda-510k.jpg K133648 - SYNGO, CT DUAL ENERGY K133648 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 2014. https://www.510kdatabase.net/k133114/ 2014-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k133114-micropuncture-introducer-set-fda-510k.jpg K133114 - MICROPUNCTURE INTRODUCER SET K133114 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Jul 2014. https://www.510kdatabase.net/k140241/ 2014-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k140241-edwards-transfemoral-balloon-catheter-fda-510k.jpg K140241 - EDWARDS TRANSFEMORAL BALLOON CATHETER K140241 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Jul 2014. https://www.510kdatabase.net/k140641/ 2014-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k140641-vessix-guide-sheath-7f-45-cm-rdc-fda-510k.jpg K140641 - VESSIX GUIDE SHEATH 7F, 45 CM, RDC, VESSIX GUIDE SHEATH 7F, 45CM, LIMA K140641 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Jul 2014. https://www.510kdatabase.net/k140902/ 2014-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k140902-e1-series-a-patellae-standard-3-peg-e1-fda-510k.jpg K140902 - E1 SERIES A PATELLAE, STANDARD 3-PEG, E1 SERIES A PATELLAE, THIN 3-PEG, E1 SERIES PATELLAE, ASYMMETRICAL, 3-PEG K140902 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jul 2014. https://www.510kdatabase.net/k133110/ 2014-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k133110-express-ld-biliary-premounted-stent-fda-510k.jpg K133110 - EXPRESS LD BILIARY PREMOUNTED STENT SYSTEM K133110 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Jul 2014. https://www.510kdatabase.net/k140411/ 2014-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k140411-altera-spacer-fda-510k.jpg K140411 - ALTERA SPACER K140411 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Jul 2014. https://www.510kdatabase.net/k140674/ 2014-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k140674-exactech-tapered-wedge-femoral-stem-fda-510k.jpg K140674 - EXACTECH TAPERED WEDGE FEMORAL STEM K140674 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Jun 2014. https://www.510kdatabase.net/k133632/ 2014-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k133632-perican-ultra-fda-510k.jpg K133632 - PERICAN ULTRA K133632 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Jun 2014. https://www.510kdatabase.net/k140823/ 2014-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k140823-permanent-beacon-transpondersoft-fda-510k.jpg K140823 - PERMANENT BEACON TRANSPONDER/SOFT TISSUE BEACON TRANSPONDER K140823 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Jun 2014. https://www.510kdatabase.net/k133816/ 2014-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k133816-immulite-2000-free-psa-calibration-fda-510k.jpg K133816 - IMMULITE 2000 FREE PSA CALIBRATION VERIFICATION MATERIAL K133816 is a FDA 510(k) cleared immunology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Jun 2014. https://www.510kdatabase.net/k141149/ 2014-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k141149-vitek-2-ast-gp-ceftaroline-fda-510k.jpg K141149 - VITEK 2 AST GP CEFTAROLINE K141149 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jun 2014. https://www.510kdatabase.net/k141199/ 2014-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k141199-quentry-dose-review-fda-510k.jpg K141199 - QUENTRY DOSE REVIEW K141199 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab AG. Cleared Jun 2014. https://www.510kdatabase.net/k141363/ 2014-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k141363-centros-long-term-hemodialysis-fda-510k.jpg K141363 - CENTROS LONG TERM HEMODIALYSIS CATHETER, CENTROSFLO LONG TERM HEMODIALYSIS CATHETER K141363 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jun 2014. https://www.510kdatabase.net/k140708/ 2014-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k140708-verify-v24-self-contained-biological-fda-510k.jpg K140708 - VERIFY V24 SELF-CONTAINED BIOLOGICAL INDICATOR K140708 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Jun 2014. https://www.510kdatabase.net/k133553/ 2014-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k133553-kalare-fda-510k.jpg K133553 - KALARE K133553 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Jun 2014. https://www.510kdatabase.net/k140312/ 2014-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k140312-ev1000-clinical-platform-with-fda-510k.jpg K140312 - EV1000 CLINICAL PLATFORM WITH CLEARSIGHT TM FINGER CUFF OR CLEARSIGHT TM SYSTEM K140312 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Jun 2014. https://www.510kdatabase.net/k140695/ 2014-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k140695-cougar-guidewire-zinger-guidwire-fda-510k.jpg K140695 - COUGAR GUIDEWIRE, ZINGER GUIDWIRE, THUNDER GUIDEWIRE, PROVIA GUIDEWIRE, INTUITION GUIDEWIRE K140695 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Jun 2014. https://www.510kdatabase.net/k141233/ 2014-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k141233-affinity-pixie-oxygenation-system-with-fda-510k.jpg K141233 - AFFINITY PIXIE OXYGENATION SYSTEM WITH K141233 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Jun 2014. https://www.510kdatabase.net/k141250/ 2014-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k141250-flexible-video-uretero-renoscope-system-fda-510k.jpg K141250 - FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM K141250 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jun 2014. https://www.510kdatabase.net/k140374/ 2014-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k140374-mastergraft-putty-fda-510k.jpg K140374 - MASTERGRAFT PUTTY K140374 is a FDA 510(k) cleared dental medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Jun 2014. https://www.510kdatabase.net/k140112/ 2014-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k140112-ca-125-ii-calset-ii-fda-510k.jpg K140112 - CA 125 II CALSET II K140112 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics. Cleared Jun 2014. https://www.510kdatabase.net/k140972/ 2014-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k140972-unipolar-pediatric-temporary-pacing-fda-510k.jpg K140972 - UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, UNIPOLAR TEMPORARY ATRIAL PACING LEAD, UNIPOLAR TEMPORARY MYOCARDIAL PACING K140972 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Jun 2014. https://www.510kdatabase.net/k141185/ 2014-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k141185-v27-software-for-the-labsystem-pro-ep-fda-510k.jpg K141185 - V2.7 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM K141185 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Jun 2014. https://www.510kdatabase.net/k140189/ 2014-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k140189-endowrist-vessel-sealer-fda-510k.jpg K140189 - ENDOWRIST VESSEL SEALER K140189 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Jun 2014. https://www.510kdatabase.net/k141261/ 2014-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k141261-logiq-s7-expert-logiq-s7-pro-fda-510k.jpg K141261 - LOGIQ S7 EXPERT, LOGIQ S7 PRO K141261 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Jun 2014. https://www.510kdatabase.net/k140891/ 2014-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k140891-biomet-cannulated-screw-system-fda-510k.jpg K140891 - BIOMET CANNULATED SCREW SYSTEM K140891 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jun 2014. https://www.510kdatabase.net/k132730/ 2014-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k132730-bio-probe-disposable-insert-with-fda-510k.jpg K132730 - BIO-PROBE DISPOSABLE INSERT WITH K132730 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared May 2014. https://www.510kdatabase.net/k133198/ 2014-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k133198-ultrapro-comfort-plug-fda-510k.jpg K133198 - ULTRAPRO COMFORT PLUG K133198 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared May 2014. https://www.510kdatabase.net/k140555/ 2014-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k140555-journey-ii-bcs-constrained-inserts-fda-510k.jpg K140555 - JOURNEY II BCS CONSTRAINED INSERTS K140555 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared May 2014. https://www.510kdatabase.net/k132801/ 2014-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k132801-immulite-2000-systems-3gallergy-fda-510k.jpg K132801 - IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY K132801 is a FDA 510(k) cleared immunology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared May 2014. https://www.510kdatabase.net/k140729/ 2014-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k140729-aplio-artida-v32-fda-510k.jpg K140729 - APLIO ARTIDA, V3.2 K140729 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared May 2014. https://www.510kdatabase.net/k141067/ 2014-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k141067-vivid-t8vivid-t8-pro-fda-510k.jpg K141067 - VIVID T8/VIVID T8 PRO K141067 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared May 2014. https://www.510kdatabase.net/k131588/ 2014-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k131588-vigileo-arterial-pressure-cardiac-fda-510k.jpg K131588 - VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR K131588 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared May 2014. https://www.510kdatabase.net/k131892/ 2014-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k131892-ev1000-clinical-platform-fda-510k.jpg K131892 - EV1000 CLINICAL PLATFORM K131892 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared May 2014. https://www.510kdatabase.net/k140192/ 2014-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k140192-carpentier-bi-caval-femoral-cannula-fda-510k.jpg K140192 - CARPENTIER BI-CAVAL FEMORAL CANNULA K140192 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared May 2014. https://www.510kdatabase.net/k140373/ 2014-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k140373-ise-indirect-na-k-c1-for-gen-2-fda-510k.jpg K140373 - ISE INDIRECT NA, K, C1 FOR GEN 2 K140373 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared May 2014. https://www.510kdatabase.net/k140454/ 2014-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k140454-navigated-cd-horizon-solera-fda-510k.jpg K140454 - NAVIGATED CD HORIZON SOLERA SCREWDRIVER/TAPS K140454 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared May 2014. https://www.510kdatabase.net/k140792/ 2014-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k140792-salvation-3di-plating-system-fda-510k.jpg K140792 - SALVATION 3DI PLATING SYSTEM K140792 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared May 2014. https://www.510kdatabase.net/k133482/ 2014-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k133482-silc-fixation-system-fda-510k.jpg K133482 - SILC FIXATION SYSTEM K133482 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared May 2014. https://www.510kdatabase.net/k140169/ 2014-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k140169-vital-portr-ct-vascular-access-system-fda-510k.jpg K140169 - VITAL-PORT(R) CT VASCULAR ACCESS SYSTEM K140169 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cook Incorporated. Cleared May 2014. https://www.510kdatabase.net/k140165/ 2014-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k140165-mc2-two-stage-venous-cannula-oval-mc2-fda-510k.jpg K140165 - MC2 TWO-STAGE VENOUS CANNULA, OVAL MC2 TWO-STAGE VENOUS CANNULA, THIN WALL TWO-STAGE VENOUS CANNULA, MC2X THREE-STAGE VE K140165 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared May 2014. https://www.510kdatabase.net/k140446/ 2014-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k140446-bd-probetec-chlamydia-trachomatis-ct-fda-510k.jpg K140446 - BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY K140446 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared May 2014. https://www.510kdatabase.net/k140448/ 2014-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k140448-bd-probetec-neisseria-gonorrhoeae-gc-fda-510k.jpg K140448 - BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY K140448 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared May 2014. https://www.510kdatabase.net/k133662/ 2014-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k133662-smith-nephew-cannulated-captured-screw-fda-510k.jpg K133662 - SMITH & NEPHEW CANNULATED CAPTURED SCREW K133662 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared May 2014. https://www.510kdatabase.net/k140741/ 2014-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k140741-salvation-beams-and-bolts-system-fda-510k.jpg K140741 - SALVATION BEAMS AND BOLTS SYSTEM K140741 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared May 2014. https://www.510kdatabase.net/k140952/ 2014-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k140952-charlotte-carolina-jones-fracture-fda-510k.jpg K140952 - CHARLOTTE CAROLINA JONES FRACTURE SYSTEM SCREW K140952 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared May 2014. https://www.510kdatabase.net/k133700/ 2014-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k133700-advanix-pancreatic-stent-and-naviflex-fda-510k.jpg K133700 - ADVANIX PANCREATIC STENT AND NAVIFLEX RAPID EXCHANGE PANCREATIC DELIVERY SYSTEM AND PUSHERS K133700 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared May 2014. https://www.510kdatabase.net/k140408/ 2014-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k140408-salvation-osteopenic-screw-fda-510k.jpg K140408 - SALVATION OSTEOPENIC SCREW K140408 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared May 2014. https://www.510kdatabase.net/k140591/ 2014-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k140591-bd-phaseal-closed-system-transfer-fda-510k.jpg K140591 - BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE - INJECTOR K140591 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson & CO. Cleared May 2014. https://www.510kdatabase.net/k141010/ 2014-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k141010-m9-diagnostic-ultrasound-system-m9t-fda-510k.jpg K141010 - M9 DIAGNOSTIC ULTRASOUND SYSTEM, M9T DIAGNOSTIC ULTRASOUND SYSTEM, M9CV DIAGNOSTIC ULTRASOUND SYSTEM K141010 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared May 2014. https://www.510kdatabase.net/k140343/ 2014-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k140343-aesculap-histoacryl-histoacryl-blue-fda-510k.jpg K140343 - AESCULAP HISTOACRYL, HISTOACRYL BLUE AND HISTOACRYL FLEXIBLE TOPICAL SKIN, ADHESIVE WITH APPLICATOR TIP K140343 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared May 2014. https://www.510kdatabase.net/k140622/ 2014-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k140622-dvr-dorsal-plate-dvr-lateral-plate-dvr-fda-510k.jpg K140622 - DVR DORSAL PLATE, DVR LATERAL PLATE, DVR ULNA PLATE K140622 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared May 2014. https://www.510kdatabase.net/k133378/ 2014-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k133378-zimmer-trabecular-metal-reverse-fda-510k.jpg K133378 - ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM K133378 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared May 2014. https://www.510kdatabase.net/k133203/ 2014-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k133203-single-site-port-fda-510k.jpg K133203 - SINGLE-SITE PORT K133203 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared May 2014. https://www.510kdatabase.net/k133251/ 2014-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k133251-bard-dignishield-stool-management-system-fda-510k.jpg K133251 - BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM K133251 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 2014. https://www.510kdatabase.net/k140404/ 2014-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k140404-elecsys-ck-mb-stat-immunoassay-fda-510k.jpg K140404 - ELECSYS CK-MB STAT IMMUNOASSAY K140404 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared May 2014. https://www.510kdatabase.net/k132397/ 2014-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k132397-gore-bio-a-wound-matrix-fda-510k.jpg K132397 - GORE BIO-A WOUND MATRIX K132397 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared May 2014. https://www.510kdatabase.net/k140311/ 2014-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k140311-caresite-luer-access-device-fda-510k.jpg K140311 - CARESITE LUER ACCESS DEVICE K140311 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared May 2014. https://www.510kdatabase.net/k140814/ 2014-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k140814-evos-mini-fragment-plating-system-fda-510k.jpg K140814 - EVOS MINI-FRAGMENT PLATING SYSTEM K140814 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared May 2014. https://www.510kdatabase.net/k140856/ 2014-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k140856-brachysource-seed-implants-with-fda-510k.jpg K140856 - BRACHYSOURCE SEED IMPLANTS WITH SOURCECAP BIOABSORBABLE CAPS K140856 is a FDA 510(k) cleared radiology medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 2014. https://www.510kdatabase.net/k140818/ 2014-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k140818-immulite-2000-free-t4-calibration-fda-510k.jpg K140818 - IMMULITE: 2000 FREE T4 CALIBRATION VERIFICATION MATERIAL, 2000 IGF-I CALIBRATION VERIFICATION MATERIAL, 2000 PROLACTIN C K140818 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared May 2014. https://www.510kdatabase.net/k132617/ 2014-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k132617-medtronic-input-ps-introducer-fda-510k.jpg K132617 - MEDTRONIC INPUT PS INTRODUCER K132617 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Apr 2014. https://www.510kdatabase.net/k133590/ 2014-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k133590-somatom-perspective-fda-510k.jpg K133590 - SOMATOM PERSPECTIVE K133590 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 2014. https://www.510kdatabase.net/k140959/ 2014-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k140959-acuson-s1000-s2000-s3000-diagnostic-fda-510k.jpg K140959 - ACUSON S1000, S2000, S3000 DIAGNOSTIC ULTRASOUND SYSTEMS K140959 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 2014. https://www.510kdatabase.net/k133580/ 2014-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k133580-artis-one-fda-510k.jpg K133580 - ARTIS ONE K133580 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 2014. https://www.510kdatabase.net/k133653/ 2014-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k133653-anatomic-peek-ptc-cervical-fusion-system-fda-510k.jpg K133653 - ANATOMIC PEEK PTC CERVICAL FUSION SYSTEM K133653 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Apr 2014. https://www.510kdatabase.net/k140733/ 2014-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k140733-constellation-multiple-electrode-fda-510k.jpg K140733 - CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETER K140733 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Apr 2014. https://www.510kdatabase.net/k140839/ 2014-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k140839-caiman-seal-and-cut-technology-fda-510k.jpg K140839 - CAIMAN SEAL AND CUT TECHNOLOGY K140839 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Apr 2014. https://www.510kdatabase.net/k123607/ 2014-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k123607-octane-elevate-spinal-implant-system-fda-510k.jpg K123607 - OCTANE ELEVATE SPINAL IMPLANT SYSTEM K123607 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Apr 2014. https://www.510kdatabase.net/k140749/ 2014-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k140749-infinity-total-ankle-system-fda-510k.jpg K140749 - INFINITY TOTAL ANKLE SYSTEM K140749 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Apr 2014. https://www.510kdatabase.net/k140080/ 2014-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k140080-envoy-distal-access-da-guiding-fda-510k.jpg K140080 - ENVOY DISTAL ACCESS (DA) GUIDING CATHETER, 6F, 95CM & 105CM, STRAIGHT & XB, MPD & XB, MPC & XB K140080 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Apr 2014. https://www.510kdatabase.net/k140307/ 2014-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k140307-envoy-guiding-catheter-fda-510k.jpg K140307 - ENVOY GUIDING CATHETER K140307 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Apr 2014. https://www.510kdatabase.net/k133597/ 2014-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k133597-ciaglia-percutaneous-tracheostomy-fda-510k.jpg K133597 - CIAGLIA PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY, CIAGLIA BLUE RHINO PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET/TRAY K133597 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Cook, Inc.. Cleared Apr 2014. https://www.510kdatabase.net/k140375/ 2014-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k140375-mastergraft-putty-mastergraft-strip-fda-510k.jpg K140375 - MASTERGRAFT PUTTY, MASTERGRAFT STRIP K140375 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Apr 2014. https://www.510kdatabase.net/k140625/ 2014-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k140625-orthosorb-ls-fda-510k.jpg K140625 - ORTHOSORB LS K140625 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Apr 2014. https://www.510kdatabase.net/k131189/ 2014-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k131189-unicel-dxc-synchron-systems-glucose-fda-510k.jpg K131189 - UNICEL DXC SYNCHRON SYSTEMS GLUCOSE REAGENT (GLUH) K131189 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Apr 2014. https://www.510kdatabase.net/k131962/ 2014-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k131962-da-vinci-sp-surgical-system-endowrist-fda-510k.jpg K131962 - DA VINCI SP SURGICAL SYSTEM, ENDOWRIST SP INSTRUMENTS, AND ACCESSORIES K131962 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Apr 2014. https://www.510kdatabase.net/k133589/ 2014-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k133589-somatom-force-fda-510k.jpg K133589 - SOMATOM FORCE K133589 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 2014. https://www.510kdatabase.net/k140495/ 2014-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k140495-leveen-standard-needle-electrode-fda-510k.jpg K140495 - LEVEEN STANDARD NEEDLE ELECTRODE, LEVEEN COACCESS NEEDLE ELECTRODE K140495 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Boston Scientific Corp. Cleared Apr 2014. https://www.510kdatabase.net/k140745/ 2014-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k140745-encore-26-advantage-kit-fda-510k.jpg K140745 - ENCORE 26 ADVANTAGE KIT K140745 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Apr 2014. https://www.510kdatabase.net/k140288/ 2014-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k140288-truepath-cto-device-fda-510k.jpg K140288 - TRUEPATH CTO DEVICE K140288 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Apr 2014. https://www.510kdatabase.net/k140475/ 2014-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k140475-rotating-adapters-fda-510k.jpg K140475 - ROTATING ADAPTERS K140475 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Apr 2014. https://www.510kdatabase.net/k140673/ 2014-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k140673-insertion-tool-fda-510k.jpg K140673 - INSERTION TOOL K140673 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Apr 2014. https://www.510kdatabase.net/k133903/ 2014-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k133903-bio-probe-transducer-adult-fda-510k.jpg K133903 - BIO-PROBE TRANSDUCER (ADULT) K133903 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Apr 2014. https://www.510kdatabase.net/k130531/ 2014-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k130531-ultrafuse-fda-510k.jpg K130531 - ULTRAFUSE K130531 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Baxter Healthcare Corp. Cleared Apr 2014. https://www.510kdatabase.net/k132902/ 2014-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k132902-syngo-dual-energy-software-package-fda-510k.jpg K132902 - SYNGO DUAL ENERGY SOFTWARE PACKAGE K132902 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 2014. https://www.510kdatabase.net/k133470/ 2014-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k133470-bard-ritecath-intermittent-catheter-fda-510k.jpg K133470 - BARD RITECATH INTERMITTENT CATHETER K133470 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 2014. https://www.510kdatabase.net/k133572/ 2014-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k133572-aria-radiation-therapy-management-fda-510k.jpg K133572 - ARIA RADIATION THERAPY MANAGEMENT K133572 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Apr 2014. https://www.510kdatabase.net/k140018/ 2014-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k140018-tsp-hip-fracture-plating-system-fda-510k.jpg K140018 - TSP HIP FRACTURE PLATING SYSTEM K140018 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Apr 2014. https://www.510kdatabase.net/k133933/ 2014-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k133933-injection-gold-probe-bipolar-fda-510k.jpg K133933 - INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER K133933 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Apr 2014. https://www.510kdatabase.net/k140541/ 2014-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k140541-immulite-2000-c-peptide-calibration-fda-510k.jpg K140541 - IMMULITE 2000: C-PEPTIDE CALIBRATION VERIFICATION MATERIAL, SHBG CALIBRATION VERIFICATION MATERIAL, TOTAL TESTOSTERONE C K140541 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Apr 2014. https://www.510kdatabase.net/k131984/ 2014-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k131984-synthes-synsonic-ulna-nail-fda-510k.jpg K131984 - SYNTHES SYNSONIC ULNA NAIL K131984 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Mar 2014. https://www.510kdatabase.net/k140505/ 2014-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k140505-advia-centaur-vitamin-b12-master-curve-fda-510k.jpg K140505 - ADVIA CENTAUR VITAMIN B12 MASTER CURVE MATERIAL, TOTAL HCG MASTER CURVE MATERIAL, AND TESTOSTERONE MASTER CURVE MATERIAL K140505 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Mar 2014. https://www.510kdatabase.net/k131861/ 2014-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k131861-da-vinci-surgical-system-endowrist-fda-510k.jpg K131861 - DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES K131861 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Mar 2014. https://www.510kdatabase.net/k140534/ 2014-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k140534-elecsys-precicontrol-ts-fda-510k.jpg K140534 - ELECSYS PRECICONTROL TS K140534 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Mar 2014. https://www.510kdatabase.net/k133539/ 2014-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k133539-total-across-fda-510k.jpg K133539 - TOTAL ACROSS K133539 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Mar 2014. https://www.510kdatabase.net/k132656/ 2014-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k132656-prodense-bone-graft-substitute-fda-510k.jpg K132656 - PRODENSE BONE GRAFT SUBSTITUTE K132656 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Mar 2014. https://www.510kdatabase.net/k140253/ 2014-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k140253-magnetom-artis-combi-suite-for-the-fda-510k.jpg K140253 - MAGNETOM ARTIS COMBI SUITE FOR THE MAGNETOM AERA/SKYRA/SKYRA WITH TIMTX TRUESHAPE K140253 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2014. https://www.510kdatabase.net/k140398/ 2014-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k140398-embol-x-introducer-sheath-fda-510k.jpg K140398 - EMBOL-X INTRODUCER SHEATH K140398 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Mar 2014. https://www.510kdatabase.net/k133227/ 2014-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k133227-smart-segmentation-knowledge-based-fda-510k.jpg K133227 - SMART SEGMENTATION - KNOWLEDGE BASED CONTOURING K133227 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Mar 2014. https://www.510kdatabase.net/k140345/ 2014-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k140345-the-sherlock-3cg-tip-confirmation-fda-510k.jpg K140345 - THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS) K140345 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 2014. https://www.510kdatabase.net/k133005/ 2014-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k133005-hemosil-von-willebrand-activity-assay-fda-510k.jpg K133005 - HEMOSIL VON WILLEBRAND ACTIVITY ASSAY K133005 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Mar 2014. https://www.510kdatabase.net/k133205/ 2014-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k133205-capstone-ptc-spinal-system-clydesdale-fda-510k.jpg K133205 - CAPSTONE PTC SPINAL SYSTEM, CLYDESDALE PTC SPINAL SYSTEM K133205 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Mar 2014. https://www.510kdatabase.net/k140276/ 2014-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k140276-cd-horizon-spinal-system-fda-510k.jpg K140276 - CD HORIZON SPINAL SYSTEM K140276 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Mar 2014. https://www.510kdatabase.net/k130981/ 2014-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k130981-flexstent-biliary-self-expanding-stent-fda-510k.jpg K130981 - FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM K130981 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Mar 2014. https://www.510kdatabase.net/k133350/ 2014-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k133350-revere-stabilization-system-fda-510k.jpg K133350 - REVERE STABILIZATION SYSTEM K133350 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Mar 2014. https://www.510kdatabase.net/k133401/ 2014-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k133401-syno-mr-neurology-syngo-mr-oncology-fda-510k.jpg K133401 - SYNO MR NEUROLOGY, SYNGO MR ONCOLOGY, SYNGO. MR BREVIS, SYNGO MMR GENERAL K133401 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2014. https://www.510kdatabase.net/k132959/ 2014-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k132959-depuy-pinnacle-altrx-acetabular-liners-fda-510k.jpg K132959 - DEPUY PINNACLE ALTRX ACETABULAR LINERS K132959 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Mar 2014. https://www.510kdatabase.net/k133864/ 2014-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k133864-dermabond-prineo-skin-closure-system-fda-510k.jpg K133864 - DERMABOND PRINEO SKIN CLOSURE SYSTEM K133864 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Mar 2014. https://www.510kdatabase.net/k140267/ 2014-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k140267-advia-centaur-tni-ultra-master-curve-fda-510k.jpg K140267 - ADVIA CENTAUR TNI-ULTRA MASTER CURVE MATERIAL (MCM), ADVIA CENTAUR DIGOXIN MASTER CURVE MATERIAL (MCM) K140267 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Mar 2014. https://www.510kdatabase.net/k140328/ 2014-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k140328-cmc-mini-tightrope-fda-510k.jpg K140328 - CMC MINI TIGHTROPE K140328 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Mar 2014. https://www.510kdatabase.net/k133713/ 2014-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k133713-charlotte-tm-snap-off-screw-fda-510k.jpg K133713 - CHARLOTTE (TM) SNAP-OFF SCREW K133713 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Mar 2014. https://www.510kdatabase.net/k140148/ 2014-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k140148-pro-toe-hammertoe-fixation-system-fda-510k.jpg K140148 - PRO-TOE HAMMERTOE FIXATION SYSTEM K140148 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Mar 2014. https://www.510kdatabase.net/k131627/ 2014-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k131627-catheter-introducer-sheath-fda-510k.jpg K131627 - CATHETER INTRODUCER SHEATH K131627 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Mar 2014. https://www.510kdatabase.net/k140208/ 2014-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k140208-ferm-flex-and-fem-flex-ii-femoral-fda-510k.jpg K140208 - FERM-FLEX AND FEM-FLEX II ( FEMORAL ACCESS ARTERIAL CANNULAE) FEMTRAK,VFEM, AND FEM-FLEXII K140208 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Mar 2014. https://www.510kdatabase.net/k140258/ 2014-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k140258-immulite-2000-dhea-so4-fda-510k.jpg K140258 - IMMULITE 2000 DHEA-SO4 K140258 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Mar 2014. https://www.510kdatabase.net/k130255/ 2014-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k130255-hemoglobin-a1c-hemoglobin-a1c-fda-510k.jpg K130255 - HEMOGLOBIN A1C, HEMOGLOBIN A1C CALIBRATORS, HEMOGLOBIN A1C CONTROLS K130255 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Feb 2014. https://www.510kdatabase.net/k131605/ 2014-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k131605-elecsys-precicontrol-cmv-igg-elecsys-fda-510k.jpg K131605 - ELECSYS PRECICONTROL CMV IGG, ELECSYS CMV IGG IMMUNOASSAY K131605 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Diagnostics. Cleared Feb 2014. https://www.510kdatabase.net/k132580/ 2014-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k132580-coated-vicryl-plus-antimicrobial-fda-510k.jpg K132580 - COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE K132580 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Feb 2014. https://www.510kdatabase.net/k132763/ 2014-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k132763-advanced-viewer-fda-510k.jpg K132763 - ADVANCED VIEWER K132763 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab AG. Cleared Feb 2014. https://www.510kdatabase.net/k132810/ 2014-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k132810-gladiator-elite-pta-balloon-dilatation-fda-510k.jpg K132810 - GLADIATOR ELITE PTA BALLOON DILATATION CATHETER K132810 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Feb 2014. https://www.510kdatabase.net/k133654/ 2014-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k133654-scenium-fda-510k.jpg K133654 - SCENIUM K133654 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 2014. https://www.510kdatabase.net/k133715/ 2014-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k133715-charlotte-claw-plate-system-fda-510k.jpg K133715 - CHARLOTTE CLAW PLATE SYSTEM K133715 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Feb 2014. https://www.510kdatabase.net/k133854/ 2014-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k133854-arthrex-ibalance-tka-system-fda-510k.jpg K133854 - ARTHREX IBALANCE TKA SYSTEM K133854 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Feb 2014. https://www.510kdatabase.net/k133644/ 2014-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k133644-syngovia-mi-workflows-fda-510k.jpg K133644 - SYNGO.VIA MI WORKFLOWS K133644 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 2014. https://www.510kdatabase.net/k133625/ 2014-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k133625-agility-10-standard-soft-001in-x-195cm-fda-510k.jpg K133625 - AGILITY 10 STANDARD & SOFT 0.01IN. X 195CM, AGILITY 14 STANDARD & SOFT 0.014IN X 205CM & XL 350CM, AGILITY 16 STANDARD & K133625 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Feb 2014. https://www.510kdatabase.net/k131426/ 2014-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k131426-medline-biopsy-valve-fda-510k.jpg K131426 - MEDLINE BIOPSY VALVE K131426 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medline Industries, Inc.. Cleared Feb 2014. https://www.510kdatabase.net/k132935/ 2014-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k132935-artiste-solution-with-sysvc10c-and-fda-510k.jpg K132935 - ARTISTE SOLUTION WITH SYS_VC10C AND SYNGO RT THERAPIST WORKSPACE, V4.3.1 UPGRADE KIT, ARIA CONNECTIVITY OPTION FOR SIEME K132935 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 2014. https://www.510kdatabase.net/k133491/ 2014-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k133491-advia-centaur-testosterone-tsto-fda-510k.jpg K133491 - ADVIA CENTAUR TESTOSTERONE (TSTO) K133491 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Feb 2014. https://www.510kdatabase.net/k131772/ 2014-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k131772-cantatar-29-microcatheter-fda-510k.jpg K131772 - CANTATA(R) 2.9 MICROCATHETER K131772 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Feb 2014. https://www.510kdatabase.net/k133567/ 2014-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k133567-unifyr-dynamic-anterior-cervical-plate-fda-510k.jpg K133567 - UNIFY(R) DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM K133567 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Feb 2014. https://www.510kdatabase.net/k133585/ 2014-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k133585-inbone-total-ankle-fda-510k.jpg K133585 - INBONE TOTAL ANKLE K133585 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Feb 2014. https://www.510kdatabase.net/k140030/ 2014-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k140030-dc-n3dc-n3s-diagnostic-ultrasound-system-fda-510k.jpg K140030 - DC-N3/DC-N3S DIAGNOSTIC ULTRASOUND SYSTEM K140030 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Feb 2014. https://www.510kdatabase.net/k132649/ 2014-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k132649-reveal-linq-insertable-cardiac-monitor-fda-510k.jpg K132649 - REVEAL LINQ INSERTABLE CARDIAC MONITOR K132649 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Feb 2014. https://www.510kdatabase.net/k133335/ 2014-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k133335-powerport-implantable-port-fda-510k.jpg K133335 - POWERPORT IMPLANTABLE PORT K133335 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Feb 2014. https://www.510kdatabase.net/k132582/ 2014-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k132582-exactech-acapella-one-cervical-spacer-fda-510k.jpg K132582 - EXACTECH ACAPELLA ONE CERVICAL SPACER SYSTEM K132582 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Feb 2014. https://www.510kdatabase.net/k132720/ 2014-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k132720-heartspan-fixed-curve-braided-fda-510k.jpg K132720 - HEARTSPAN FIXED CURVE BRAIDED TRANSSEPTAL SHEATH K132720 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Feb 2014. https://www.510kdatabase.net/k133533/ 2014-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k133533-logiq-e-fda-510k.jpg K133533 - LOGIQ E K133533 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Feb 2014. https://www.510kdatabase.net/k140063/ 2014-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k140063-equinoxe-extra-short-humeral-head-fda-510k.jpg K140063 - EQUINOXE EXTRA SHORT HUMERAL HEAD K140063 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Feb 2014. https://www.510kdatabase.net/k123880/ 2014-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k123880-quanta-flash-centromere-fda-510k.jpg K123880 - QUANTA FLASH CENTROMERE K123880 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Feb 2014. https://www.510kdatabase.net/k133247/ 2014-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k133247-eclipse-treatment-planning-system-fda-510k.jpg K133247 - ECLIPSE TREATMENT PLANNING SYSTEM K133247 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Feb 2014. https://www.510kdatabase.net/k133601/ 2014-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k133601-advia-centaur-intact-parathyroid-fda-510k.jpg K133601 - ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAY K133601 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Feb 2014. https://www.510kdatabase.net/k132886/ 2014-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k132886-smith-nephew-variable-angle-locking-fda-510k.jpg K132886 - SMITH & NEPHEW VARIABLE-ANGLE LOCKING MINI-FRAGMENT PLATING SYSTEM K132886 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Feb 2014. https://www.510kdatabase.net/k133737/ 2014-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k133737-zimmerr-persona-the-personalized-kee-fda-510k.jpg K133737 - ZIMMER(R) PERSONA THE PERSONALIZED KEE SYSTEM 14X +30MM TAPERED STEM EXTENSION K133737 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Feb 2014. https://www.510kdatabase.net/k132767/ 2014-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k132767-medline-sharps-container-fda-510k.jpg K132767 - MEDLINE SHARPS CONTAINER K132767 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Feb 2014. https://www.510kdatabase.net/k133034/ 2014-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k133034-logiq-f-series-fda-510k.jpg K133034 - LOGIQ F SERIES K133034 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Jan 2014. https://www.510kdatabase.net/k133240/ 2014-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k133240-varian-multileaf-collimator-fda-510k.jpg K133240 - VARIAN MULTILEAF COLLIMATOR K133240 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Jan 2014. https://www.510kdatabase.net/k133275/ 2014-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k133275-mini-tightrope-fda-510k.jpg K133275 - MINI TIGHTROPE K133275 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jan 2014. https://www.510kdatabase.net/k140019/ 2014-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k140019-arthrex-biosuture-fda-510k.jpg K140019 - ARTHREX BIOSUTURE K140019 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Arthrex, Inc.. Cleared Jan 2014. https://www.510kdatabase.net/k131204/ 2014-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k131204-advance-cs-coronary-sinus-infusion-fda-510k.jpg K131204 - ADVANCE CS CORONARY SINUS INFUSION CATHETER K131204 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Jan 2014. https://www.510kdatabase.net/k131413/ 2014-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k131413-xtrafix-small-external-fixation-system-fda-510k.jpg K131413 - XTRAFIX SMALL EXTERNAL FIXATION SYSTEM K131413 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jan 2014. https://www.510kdatabase.net/k131244/ 2014-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k131244-elecsys-ft4-ii-assay-elecsys-ft4-ii-fda-510k.jpg K131244 - ELECSYS FT4 II ASSAY, ELECSYS FT4 II CALSET K131244 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Jan 2014. https://www.510kdatabase.net/k132638/ 2014-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k132638-dimension-creatinine-cre2-flex-reagent-fda-510k.jpg K132638 - DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE K132638 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Jan 2014. https://www.510kdatabase.net/k133331/ 2014-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k133331-4d-integrated-treatment-console-fda-510k.jpg K133331 - 4D INTEGRATED TREATMENT CONSOLE K133331 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Jan 2014. https://www.510kdatabase.net/k133354/ 2014-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k133354-peri-prosthetic-cable-system-fda-510k.jpg K133354 - PERI-PROSTHETIC CABLE SYSTEM K133354 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jan 2014. https://www.510kdatabase.net/k131307/ 2014-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k131307-advia-chemistry-fructosamine-assay-fda-510k.jpg K131307 - ADVIA CHEMISTRY FRUCTOSAMINE ASSAY, ADVIA CHEMISTRY FRUCTOSAMINE CALIBRATOR K131307 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Jan 2014. https://www.510kdatabase.net/k131500/ 2014-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k131500-yasargil-aneurysm-clips-and-clip-fda-510k.jpg K131500 - YASARGIL ANEURYSM CLIPS AND CLIP APPLIERS K131500 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Jan 2014. https://www.510kdatabase.net/k133259/ 2014-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k133259-ysio-max-fda-510k.jpg K133259 - YSIO MAX K133259 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 2014. https://www.510kdatabase.net/k133728/ 2014-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k133728-dimension-vista-creatinine-cre2-flex-fda-510k.jpg K133728 - DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE K133728 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Jan 2014. https://www.510kdatabase.net/k133987/ 2014-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k133987-captivator-iisingle-use-polypectomy-fda-510k.jpg K133987 - CAPTIVATOR II,SINGLE-USE POLYPECTOMY SNARES K133987 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Jan 2014. https://www.510kdatabase.net/k132722/ 2014-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k132722-hemosil-recombiplastin-2g-8-ml-vial-fda-510k.jpg K132722 - HEMOSIL RECOMBIPLASTIN 2G (8 ML VIAL) K132722 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jan 2014. https://www.510kdatabase.net/k133424/ 2014-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k133424-somatom-emotion-6-ct-systems-somatom-fda-510k.jpg K133424 - SOMATOM EMOTION 6 CT SYSTEMS, SOMATOM EMOTION 16 K133424 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 2014. https://www.510kdatabase.net/k133856/ 2014-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k133856-powerglide-midline-catheter-fda-510k.jpg K133856 - POWERGLIDE MIDLINE CATHETER K133856 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 2014. https://www.510kdatabase.net/k132739/ 2014-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k132739-immulite-2000-afp-br-ma-and-om-ma-fda-510k.jpg K132739 - IMMULITE 2000 AFP, BR-MA, AND OM-MA CALIBRATION VERIFICATION MATERIAL K132739 is a FDA 510(k) cleared immunology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Jan 2014. https://www.510kdatabase.net/k133407/ 2014-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k133407-gem-premier-4000-fda-510k.jpg K133407 - GEM PREMIER 4000 K133407 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jan 2014. https://www.510kdatabase.net/k133750/ 2014-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k133750-occluder-occlusion-balloon-catheter-fda-510k.jpg K133750 - OCCLUDER OCCLUSION BALLOON CATHETER K133750 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Jan 2014. https://www.510kdatabase.net/k130122/ 2014-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k130122-beckman-coulter-immage-immunochemistry-fda-510k.jpg K130122 - BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER K130122 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jan 2014. https://www.510kdatabase.net/k132296/ 2014-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k132296-d-rad-smart-pack-fda-510k.jpg K132296 - D-RAD SMART PACK K132296 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jan 2014. https://www.510kdatabase.net/k133167/ 2014-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k133167-monopolar-cautery-cord-bipolar-cautery-fda-510k.jpg K133167 - MONOPOLAR CAUTERY CORD, BIPOLAR CAUTERY CORD K133167 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Jan 2014. https://www.510kdatabase.net/k133312/ 2014-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k133312-expect-slimline-endoscopic-ultrasound-fda-510k.jpg K133312 - EXPECT SLIMLINE ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE K133312 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Jan 2014. https://www.510kdatabase.net/k133645/ 2014-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k133645-perimeter-c-spinal-system-capstone-fda-510k.jpg K133645 - PERIMETER C SPINAL SYSTEM, CAPSTONE SPINAL SYSTEM, CAPSTONE L SPINAL SYSTEM, PERIMETER SPINAL SYSTEM K133645 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Jan 2014. https://www.510kdatabase.net/k131364/ 2014-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k131364-flexible-cmos-video-cysto-urethroscope-fda-510k.jpg K131364 - FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPE K131364 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jan 2014. https://www.510kdatabase.net/k132559/ 2013-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k132559-monument-spacers-fda-510k.jpg K132559 - MONUMENT SPACERS K132559 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Dec 2013. https://www.510kdatabase.net/k130895/ 2013-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k130895-reunion-rsa-shoulder-system-fda-510k.jpg K130895 - REUNION RSA SHOULDER SYSTEM K130895 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Dec 2013. https://www.510kdatabase.net/k130977/ 2013-12-24 monthly 0.5 https://www.510kdatabase.net/og-image/k130977-signify-bioactive-fda-510k.jpg K130977 - SIGNIFY BIOACTIVE K130977 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Dec 2013. https://www.510kdatabase.net/k131164/ 2013-12-24 monthly 0.5 https://www.510kdatabase.net/og-image/k131164-acuson-fda-510k.jpg K131164 - ACUSON K131164 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Dec 2013. https://www.510kdatabase.net/k133431/ 2013-12-24 monthly 0.5 https://www.510kdatabase.net/og-image/k133431-venue-50-fda-510k.jpg K133431 - VENUE 50 K133431 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Dec 2013. https://www.510kdatabase.net/k132386/ 2013-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k132386-totalshield-surgical-helmet-system-fda-510k.jpg K132386 - TOTALSHIELD SURGICAL HELMET SYSTEM K132386 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zimmer, Inc.. Cleared Dec 2013. https://www.510kdatabase.net/k133634/ 2013-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k133634-spectrum-turbo-ject-peripherally-fda-510k.jpg K133634 - SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET K133634 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cook, Inc.. Cleared Dec 2013. https://www.510kdatabase.net/k131953/ 2013-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k131953-image1-spies-fda-510k.jpg K131953 - IMAGE1 SPIES K131953 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Dec 2013. https://www.510kdatabase.net/k133566/ 2013-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k133566-rotablator-rotational-atherectomy-fda-510k.jpg K133566 - ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL ROTALINK PLUS K133566 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Dec 2013. https://www.510kdatabase.net/k133650/ 2013-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k133650-capstone-spinal-system-fda-510k.jpg K133650 - CAPSTONE SPINAL SYSTEM K133650 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Dec 2013. https://www.510kdatabase.net/k132418/ 2013-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k132418-cobas-c-501-ise-indirect-na-k-cl-for-fda-510k.jpg K132418 - COBAS C 501 ISE INDIRECT NA, K, CL FOR GEN. 2 K132418 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Dec 2013. https://www.510kdatabase.net/k133246/ 2013-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k133246-zimmer-distal-radius-plating-system-fda-510k.jpg K133246 - ZIMMER DISTAL RADIUS PLATING SYSTEM K133246 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Dec 2013. https://www.510kdatabase.net/k133342/ 2013-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k133342-arthrex-ibalance-tka-system-fda-510k.jpg K133342 - ARTHREX IBALANCE TKA SYSTEM K133342 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Dec 2013. https://www.510kdatabase.net/k132015/ 2013-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k132015-truclear-morcellation-system-and-fda-510k.jpg K132015 - TRUCLEAR MORCELLATION SYSTEM AND TRUCLEAR MORCELLATORS K132015 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Dec 2013. https://www.510kdatabase.net/k132441/ 2013-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k132441-bard-ventralex-hernia-patch-fda-510k.jpg K132441 - BARD VENTRALEX HERNIA PATCH K132441 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 2013. https://www.510kdatabase.net/k133074/ 2013-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k133074-mega-8fr-50cc-and-sensation-plus-8fr-fda-510k.jpg K133074 - MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIES K133074 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Dec 2013. https://www.510kdatabase.net/k133230/ 2013-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k133230-inqwire-diagnostic-guide-wire-fda-510k.jpg K133230 - INQWIRE DIAGNOSTIC GUIDE WIRE K133230 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Dec 2013. https://www.510kdatabase.net/k133435/ 2013-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k133435-magnetom-aera-and-skyra-with-software-fda-510k.jpg K133435 - MAGNETOM AERA AND SKYRA WITH SOFTWARE MR D13A K133435 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Dec 2013. https://www.510kdatabase.net/k130708/ 2013-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k130708-smith-nephew-patient-matched-cutting-fda-510k.jpg K130708 - SMITH & NEPHEW PATIENT MATCHED CUTTING BLOCKS K130708 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Dec 2013. https://www.510kdatabase.net/k132873/ 2013-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k132873-vanguard-xp-knee-system-fda-510k.jpg K132873 - VANGUARD XP KNEE SYSTEM K132873 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Dec 2013. https://www.510kdatabase.net/k130004/ 2013-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k130004-ultraflex-esophageal-ng-stent-system-fda-510k.jpg K130004 - ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM K130004 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Dec 2013. https://www.510kdatabase.net/k132328/ 2013-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k132328-cd-horizon-spinal-system-fda-510k.jpg K132328 - CD HORIZON SPINAL SYSTEM K132328 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Dec 2013. https://www.510kdatabase.net/k133356/ 2013-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k133356-prolene-polypropylene-nonabsorbable-fda-510k.jpg K133356 - PROLENE POLYPROPYLENE NONABSORBABLE SUTURE K133356 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Dec 2013. https://www.510kdatabase.net/k132079/ 2013-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k132079-tfcc-fast-fix-kit-fda-510k.jpg K132079 - TFCC FAST-FIX KIT K132079 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Dec 2013. https://www.510kdatabase.net/k132584/ 2013-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k132584-perimeter-c-spinal-system-fda-510k.jpg K132584 - PERIMETER C SPINAL SYSTEM K132584 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Dec 2013. https://www.510kdatabase.net/k132828/ 2013-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k132828-elecsys-calcitonin-fda-510k.jpg K132828 - ELECSYS CALCITONIN K132828 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Dec 2013. https://www.510kdatabase.net/k132134/ 2013-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k132134-optifix-absorbable-fixation-system-fda-510k.jpg K132134 - OPTIFIX ABSORBABLE FIXATION SYSTEM K132134 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 2013. https://www.510kdatabase.net/k131298/ 2013-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k131298-exactech-equinoxe-resurfacing-humeral-fda-510k.jpg K131298 - EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM K131298 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Nov 2013. https://www.510kdatabase.net/k131369/ 2013-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k131369-flexible-video-uretero-renoscope-system-fda-510k.jpg K131369 - FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM K131369 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Nov 2013. https://www.510kdatabase.net/k133330/ 2013-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k133330-cfas-proteins-cfas-pac-precicontrol-fda-510k.jpg K133330 - C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEIN K133330 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Nov 2013. https://www.510kdatabase.net/k132217/ 2013-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k132217-arthrex-compression-ft-screws-fda-510k.jpg K132217 - ARTHREX COMPRESSION FT SCREWS K132217 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Nov 2013. https://www.510kdatabase.net/k132639/ 2013-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k132639-cd-horizon-spinal-system-fda-510k.jpg K132639 - CD HORIZON SPINAL SYSTEM K132639 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Nov 2013. https://www.510kdatabase.net/k132119/ 2013-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k132119-magnetom-prisma-magnetom-prisma-fit-fda-510k.jpg K132119 - MAGNETOM PRISMA, MAGNETOM PRISMA FIT K132119 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2013. https://www.510kdatabase.net/k132191/ 2013-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k132191-sp-fix-spinous-process-fixation-plate-fda-510k.jpg K132191 - SP-FIX SPINOUS PROCESS FIXATION PLATE K132191 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Nov 2013. https://www.510kdatabase.net/k133067/ 2013-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k133067-advia-chemistry-triglycerides2-trig2-fda-510k.jpg K133067 - ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT K133067 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Nov 2013. https://www.510kdatabase.net/k133284/ 2013-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k133284-elecsys-ck-mb-calcheck-5-fda-510k.jpg K133284 - ELECSYS CK-MB CALCHECK 5 K133284 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Nov 2013. https://www.510kdatabase.net/k132168/ 2013-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k132168-bronchoscopy-elbow-fda-510k.jpg K132168 - BRONCHOSCOPY ELBOW K132168 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Nov 2013. https://www.510kdatabase.net/k132712/ 2013-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k132712-affinity-cp-centrifugal-blood-pump-fda-510k.jpg K132712 - AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTER K132712 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Nov 2013. https://www.510kdatabase.net/k132779/ 2013-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k132779-dc-n2dc-n2s-diagnostic-ultrasound-system-fda-510k.jpg K132779 - DC-N2/DC-N2S DIAGNOSTIC ULTRASOUND SYSTEM K132779 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Nov 2013. https://www.510kdatabase.net/k132507/ 2013-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k132507-vitek-2-ast-st-meropenem-fda-510k.jpg K132507 - VITEK 2 AST ST MEROPENEM K132507 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Nov 2013. https://www.510kdatabase.net/k132951/ 2013-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k132951-magnetom-aera-fda-510k.jpg K132951 - MAGNETOM AERA K132951 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2013. https://www.510kdatabase.net/k133140/ 2013-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k133140-bd-veritor-system-for-the-rapid-fda-510k.jpg K133140 - BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV K133140 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Nov 2013. https://www.510kdatabase.net/k133208/ 2013-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k133208-interlock-35-fibered-idc-occlusion-fda-510k.jpg K133208 - INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM K133208 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Nov 2013. https://www.510kdatabase.net/k133138/ 2013-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k133138-bd-veritor-system-flu-ab-assay-fda-510k.jpg K133138 - BD Veritor™ System Flu A+B Assay K133138 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Nov 2013. https://www.510kdatabase.net/k132106/ 2013-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k132106-infinix-angio-workstation-wdts-software-fda-510k.jpg K132106 - INFINIX ANGIO WORKSTATION W/DTS SOFTWARE K132106 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Nov 2013. https://www.510kdatabase.net/k133226/ 2013-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k133226-biograph-mmr-fda-510k.jpg K133226 - BIOGRAPH MMR K133226 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2013. https://www.510kdatabase.net/k132913/ 2013-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k132913-voluson-e6-e8-e8expert-e8expert-fda-510k.jpg K132913 - VOLUSON E6 / E8 / E8EXPERT / E8EXPERT LIMITED EDITION / E10 K132913 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Nov 2013. https://www.510kdatabase.net/k132155/ 2013-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k132155-merit-asaplp-aspiration-catheter-fda-510k.jpg K132155 - Merit ASAPLP Aspiration Catheter K132155 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Nov 2013. https://www.510kdatabase.net/k131700/ 2013-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k131700-sensation-short-throw-captiflex-fda-510k.jpg K131700 - SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE, SINGLE-USE POLYPECTOMY SNARES K131700 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Nov 2013. https://www.510kdatabase.net/k131669/ 2013-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k131669-perimeter-interbody-fusion-device-fda-510k.jpg K131669 - PERIMETER INTERBODY FUSION DEVICE K131669 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Nov 2013. https://www.510kdatabase.net/k132831/ 2013-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k132831-quietsilent-scanning-suite-fda-510k.jpg K132831 - QUIET/SILENT SCANNING SUITE K132831 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2013. https://www.510kdatabase.net/k131914/ 2013-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k131914-offroad-re-entry-catheter-system-fda-510k.jpg K131914 - OFFROAD RE-ENTRY CATHETER SYSTEM K131914 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Oct 2013. https://www.510kdatabase.net/k132705/ 2013-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k132705-unique-fda-510k.jpg K132705 - UNIQUE K132705 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Oct 2013. https://www.510kdatabase.net/k132924/ 2013-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k132924-medtronic-external-pulse-generator-epg-fda-510k.jpg K132924 - MEDTRONIC EXTERNAL PULSE GENERATOR (EPG) K132924 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Oct 2013. https://www.510kdatabase.net/k132995/ 2013-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k132995-dlp-retrograde-coronary-sinus-fda-510k.jpg K132995 - DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITHOUT PRESSURE MONITORING LINE, DLP RETROGRADE CORONARY SINUS PERFUSIO K132995 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Oct 2013. https://www.510kdatabase.net/k130675/ 2013-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k130675-arthrex-univers-ii-ca-heads-fda-510k.jpg K130675 - ARTHREX UNIVERS II CA HEADS K130675 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Oct 2013. https://www.510kdatabase.net/k132357/ 2013-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k132357-smith-nephew-ultratape-fda-510k.jpg K132357 - SMITH & NEPHEW ULTRATAPE K132357 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 2013. https://www.510kdatabase.net/k133122/ 2013-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k133122-immulite-2000-fda-510k.jpg K133122 - IMMULITE 2000 K133122 is a FDA 510(k) cleared immunology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Oct 2013. https://www.510kdatabase.net/k131867/ 2013-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k131867-25mm-inline-fusion-plate-fda-510k.jpg K131867 - 2.5MM INLINE FUSION PLATE K131867 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Oct 2013. https://www.510kdatabase.net/k132972/ 2013-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k132972-affinity-fusion-cardiotomyvenous-fda-510k.jpg K132972 - AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE K132972 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Oct 2013. https://www.510kdatabase.net/k132020/ 2013-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k132020-advance-34lp-low-profile-pta-balloon-fda-510k.jpg K132020 - ADVANCE 34LP LOW PROFILE PTA BALLOON DILATATION CATHETER K132020 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Oct 2013. https://www.510kdatabase.net/k133124/ 2013-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k133124-immulite-2000-fda-510k.jpg K133124 - IMMULITE 2000 K133124 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Oct 2013. https://www.510kdatabase.net/k131679/ 2013-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k131679-evolution-mp-adaptive-ps-tibial-insert-fda-510k.jpg K131679 - EVOLUTION MP ADAPTIVE PS TIBIAL INSERT K131679 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Oct 2013. https://www.510kdatabase.net/k132446/ 2013-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k132446-renasys-ez-max-negative-pressure-wound-fda-510k.jpg K132446 - RENASYS EZ MAX NEGATIVE PRESSURE WOUND THERAPY DEVICE K132446 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 2013. https://www.510kdatabase.net/k132895/ 2013-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k132895-wmt-implantable-k-wire-fda-510k.jpg K132895 - WMT IMPLANTABLE K-WIRE K132895 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Oct 2013. https://www.510kdatabase.net/k132435/ 2013-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k132435-smith-nephew-global-femoral-head-trials-fda-510k.jpg K132435 - SMITH & NEPHEW GLOBAL FEMORAL HEAD TRIALS K132435 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 2013. https://www.510kdatabase.net/k132673/ 2013-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k132673-5f-6f-launcher-guide-catheter-5f-fda-510k.jpg K132673 - 5F & 6F LAUNCHER GUIDE CATHETER, 5F SHERPA ACTIVE NX GUIDE CATHETER, 6F Z4 GUIDING CATHETER K132673 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Oct 2013. https://www.510kdatabase.net/k132990/ 2013-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k132990-occlusion-balloon-catheter-fda-510k.jpg K132990 - OCCLUSION BALLOON CATHETER K132990 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Oct 2013. https://www.510kdatabase.net/k133128/ 2013-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k133128-immulite-2000-fda-510k.jpg K133128 - IMMULITE 2000 K133128 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Oct 2013. https://www.510kdatabase.net/k131982/ 2013-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k131982-remstar-auto-a-flex-ht-fda-510k.jpg K131982 - REMSTAR AUTO A-FLEX HT K131982 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Oct 2013. https://www.510kdatabase.net/k132571/ 2013-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k132571-elecsys-ck-mb-stat-immunoassay-elecsys-fda-510k.jpg K132571 - ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY K132571 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Oct 2013. https://www.510kdatabase.net/k132947/ 2013-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k132947-direxion-and-direxion-hi-flo-fda-510k.jpg K132947 - DIREXION AND DIREXION HI-FLO TORQUEABLE MICROCATHETERS K132947 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Oct 2013. https://www.510kdatabase.net/k131994/ 2013-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k131994-somnolyzer-24x7-fda-510k.jpg K131994 - SOMNOLYZER 24X7 K131994 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Oct 2013. https://www.510kdatabase.net/k132430/ 2013-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k132430-sterling-over-the-wire-otw-pta-balloon-fda-510k.jpg K132430 - STERLING OVER-THE-WIRE (OTW) PTA BALLOON DILATATION CATHETER K132430 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Oct 2013. https://www.510kdatabase.net/k132636/ 2013-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k132636-dyonics-plan-hip-impingement-planning-fda-510k.jpg K132636 - DYONICS PLAN HIP IMPINGEMENT PLANNING SYSTEM K132636 is a FDA 510(k) cleared radiology medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 2013. https://www.510kdatabase.net/k132942/ 2013-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k132942-site-rite-vision-ii-ultrasound-system-fda-510k.jpg K132942 - SITE-RITE VISION II ULTRASOUND SYSTEM K132942 is a FDA 510(k) cleared radiology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 2013. https://www.510kdatabase.net/k122949/ 2013-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k122949-medline-suction-coagulator-fda-510k.jpg K122949 - MEDLINE SUCTION COAGULATOR K122949 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medline Industries, Inc.. Cleared Oct 2013. https://www.510kdatabase.net/k132664/ 2013-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k132664-advia-chemistry-albumin-bcp-reagent-fda-510k.jpg K132664 - ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR K132664 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Oct 2013. https://www.510kdatabase.net/k130881/ 2013-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k130881-acuson-s2000-and-s3000-fda-510k.jpg K130881 - ACUSON S2000 AND S3000 K130881 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 2013. https://www.510kdatabase.net/k131807/ 2013-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k131807-high-energy-linear-accelerator-fda-510k.jpg K131807 - HIGH ENERGY LINEAR ACCELERATOR K131807 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Oct 2013. https://www.510kdatabase.net/k132161/ 2013-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k132161-optetrak-logic-ps-17mm-19mm-thick-fda-510k.jpg K132161 - OPTETRAK LOGIC PS 17MM & 19MM THICK INSERTS, OPTETRAK LOGIC PSC 17MM & 19MM THICK INSERTS K132161 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Oct 2013. https://www.510kdatabase.net/k132885/ 2013-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k132885-turbo-ject-peripherally-inserted-fda-510k.jpg K132885 - TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET K132885 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cook Incorporated. Cleared Oct 2013. https://www.510kdatabase.net/k130728/ 2013-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k130728-polarstem-standard-and-lateral-femoral-fda-510k.jpg K130728 - POLARSTEM STANDARD AND LATERAL FEMORAL STEMS WITH TI/HA K130728 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 2013. https://www.510kdatabase.net/k131662/ 2013-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k131662-immulite-2000-acth-calibration-fda-510k.jpg K131662 - IMMULITE 2000 ACTH CALIBRATION VERIFICATION MATERIAL K131662 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Oct 2013. https://www.510kdatabase.net/k131684/ 2013-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k131684-bioloxr-delta-ceramic-heads-fda-510k.jpg K131684 - BIOLOX(R) DELTA CERAMIC HEADS K131684 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Oct 2013. https://www.510kdatabase.net/k131779/ 2013-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k131779-vitek-2-ast-st-tigecycline-fda-510k.jpg K131779 - VITEK 2 AST-ST TIGECYCLINE K131779 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Oct 2013. https://www.510kdatabase.net/k130857/ 2013-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k130857-prontosan-wound-gel-x-fda-510k.jpg K130857 - PRONTOSAN WOUND GEL X K130857 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Oct 2013. https://www.510kdatabase.net/k132471/ 2013-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k132471-cd-horizon-spinal-system-fda-510k.jpg K132471 - CD HORIZON SPINAL SYSTEM K132471 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Oct 2013. https://www.510kdatabase.net/k132734/ 2013-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k132734-neutral-luer-activated-device-one-link-fda-510k.jpg K132734 - NEUTRAL LUER ACTIVATED DEVICE (ONE-LINK NEEDLE-FREE IV CONNECTOR) AND EXTENSION SETS K132734 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Oct 2013. https://www.510kdatabase.net/k131143/ 2013-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k131143-trellis-collagen-ribbon-fda-510k.jpg K131143 - TRELLIS COLLAGEN RIBBON K131143 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Oct 2013. https://www.510kdatabase.net/k131201/ 2013-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k131201-entuit-secure-gastrointestional-suture-fda-510k.jpg K131201 - ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SET K131201 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook, Inc.. Cleared Oct 2013. https://www.510kdatabase.net/k131479/ 2013-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k131479-v8-sp-normal-control-abnormal-control-fda-510k.jpg K131479 - V8 SP NORMAL CONTROL, ABNORMAL CONTROL K131479 is a FDA 510(k) cleared immunology medical device. Manufacturer: Helena Laboratories. Cleared Oct 2013. https://www.510kdatabase.net/k132645/ 2013-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k132645-thoratrak-mics-retractor-system-rack-fda-510k.jpg K132645 - THORATRAK MICS RETRACTOR SYSTEM, RACK, BLADES K132645 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medtronic, Inc.. Cleared Oct 2013. https://www.510kdatabase.net/k131673/ 2013-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k131673-magnifuse-bone-graft-magifuse-ii-bone-fda-510k.jpg K131673 - MAGNIFUSE BONE GRAFT, MAGIFUSE II BONE GRAFT K131673 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Oct 2013. https://www.510kdatabase.net/k130020/ 2013-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k130020-access-total-bhcg-5th-is-fda-510k.jpg K130020 - ACCESS TOTAL BHCG (5TH IS) K130020 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Oct 2013. https://www.510kdatabase.net/k131206/ 2013-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k131206-cook-cervical-ripening-balloon-fda-510k.jpg K131206 - COOK CERVICAL RIPENING BALLOON K131206 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Cook, Inc.. Cleared Sep 2013. https://www.510kdatabase.net/k131633/ 2013-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k131633-arthrex-univers-apex-fda-510k.jpg K131633 - ARTHREX UNIVERS APEX K131633 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Sep 2013. https://www.510kdatabase.net/k131656/ 2013-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k131656-morcellex-sigma-generator-fda-510k.jpg K131656 - MORCELLEX SIGMA GENERATOR K131656 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ethicon, Inc.. Cleared Sep 2013. https://www.510kdatabase.net/k132030/ 2013-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k132030-micra-introducer-sheath-with-fda-510k.jpg K132030 - MICRA INTRODUCER SHEATH WITH HYDROPHILIC COATING K132030 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Sep 2013. https://www.510kdatabase.net/k121790/ 2013-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k121790-access-accutni-reagent-access-accutni-fda-510k.jpg K121790 - ACCESS ACCUTNI REAGENT, ACCESS ACCUTNI CALIBRATOR, UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM K121790 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Sep 2013. https://www.510kdatabase.net/k130510/ 2013-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k130510-arthrex-compression-plates-fda-510k.jpg K130510 - ARTHREX COMPRESSION PLATES K130510 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Sep 2013. https://www.510kdatabase.net/k131891/ 2013-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k131891-eclipse-treatment-planning-system-fda-510k.jpg K131891 - ECLIPSE TREATMENT PLANNING SYSTEM K131891 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Sep 2013. https://www.510kdatabase.net/k131937/ 2013-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k131937-voluson-ie-fda-510k.jpg K131937 - VOLUSON I/E K131937 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Sep 2013. https://www.510kdatabase.net/k130177/ 2013-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k130177-anatomic-peek-cervical-fusion-system-fda-510k.jpg K130177 - ANATOMIC PEEK CERVICAL FUSION SYSTEM K130177 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Sep 2013. https://www.510kdatabase.net/k130810/ 2013-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k130810-zimmer-motionloc-screw-for-fda-510k.jpg K130810 - ZIMMER MOTIONLOC SCREW FOR PERIARTICULAR LOCKING PLATE SYSTEM K130810 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Sep 2013. https://www.510kdatabase.net/k130373/ 2013-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k130373-navios-flow-cytometer-system-fda-510k.jpg K130373 - NAVIOS FLOW CYTOMETER SYSTEM K130373 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Sep 2013. https://www.510kdatabase.net/k132314/ 2013-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k132314-medline-anti-reflux-valve-fda-510k.jpg K132314 - MEDLINE ANTI-REFLUX VALVE K132314 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medline Industries, Inc.. Cleared Sep 2013. https://www.510kdatabase.net/k130595/ 2013-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k130595-zimmer-natural-nail-system-tibial-nail-fda-510k.jpg K130595 - ZIMMER NATURAL NAIL SYSTEM TIBIAL NAIL AND STAINLESS STEEL TIBIAL NAIL K130595 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Sep 2013. https://www.510kdatabase.net/k131977/ 2013-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k131977-centricity-universal-viewer-zero-fda-510k.jpg K131977 - CENTRICITY UNIVERSAL VIEWER ZERO FOOTPRINT CLIENT K131977 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Sep 2013. https://www.510kdatabase.net/k132164/ 2013-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k132164-heartspan-steerable-introducer-kit-fda-510k.jpg K132164 - HEARTSPAN STEERABLE INTRODUCER KIT K132164 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Sep 2013. https://www.510kdatabase.net/k124031/ 2013-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k124031-da-vinci-fluorescence-imaging-vision-fda-510k.jpg K124031 - DA VINCI FLUORESCENCE IMAGING VISION SYSTEM K124031 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Sep 2013. https://www.510kdatabase.net/k132175/ 2013-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k132175-edwards-lifesciences-intraclude-intra-fda-510k.jpg K132175 - EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER K132175 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Sep 2013. https://www.510kdatabase.net/k132249/ 2013-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k132249-advia-centaur-ft4-advia-centaur-t4-fda-510k.jpg K132249 - ADVIA CENTAUR FT4, ADVIA CENTAUR T4 K132249 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Sep 2013. https://www.510kdatabase.net/k132573/ 2013-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k132573-vitek-2-ast-st-moxifloxacin-vitek-2-fda-510k.jpg K132573 - VITEK 2 AST ST MOXIFLOXACIN, VITEK 2 AST STREPTOCOCCUS MOXIFLOXACIN K132573 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Sep 2013. https://www.510kdatabase.net/k132578/ 2013-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k132578-interlock-18-fibered-idc-occlusion-fda-510k.jpg K132578 - INTERLOCK - 18 FIBERED IDC OCCLUSION SYSTEM K132578 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Sep 2013. https://www.510kdatabase.net/k131658/ 2013-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k131658-gore-seamguard-reinforcement-fda-510k.jpg K131658 - GORE SEAMGUARD REINFORCEMENT K131658 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Sep 2013. https://www.510kdatabase.net/k130610/ 2013-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k130610-sirius-femoral-stem-fda-510k.jpg K130610 - SIRIUS FEMORAL STEM K130610 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Aug 2013. https://www.510kdatabase.net/k130792/ 2013-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k130792-lifestent-biliary-stent-system-fda-510k.jpg K130792 - LIFESTENT BILIARY STENT SYSTEM, LIFESTENT XL BILIARY STENT SYSTEM K130792 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Aug 2013. https://www.510kdatabase.net/k132281/ 2013-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k132281-revive-pv-peripheral-vasculature-fda-510k.jpg K132281 - ReVive PV (Peripheral Vasculature) Thrombectomy Device K132281 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Aug 2013. https://www.510kdatabase.net/k130266/ 2013-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k130266-endowrist-one-vessel-sealer-fda-510k.jpg K130266 - ENDOWRIST ONE VESSEL SEALER K130266 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Aug 2013. https://www.510kdatabase.net/k132409/ 2013-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k132409-concierge-guiding-catheter-fda-510k.jpg K132409 - CONCIERGE GUIDING CATHETER K132409 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Aug 2013. https://www.510kdatabase.net/k131527/ 2013-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k131527-logiq-s8-fda-510k.jpg K131527 - LOGIQ S8 K131527 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Aug 2013. https://www.510kdatabase.net/k130268/ 2013-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k130268-bd-probetec-trichomonas-vaginalis-tv-fda-510k.jpg K130268 - BD PROBETEC TRICHOMONAS VAGINALIS (TV) QX AMPLIFIED DNA ASSAY K130268 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Aug 2013. https://www.510kdatabase.net/k132054/ 2013-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k132054-gynecare-tvt-exact-continence-system-fda-510k.jpg K132054 - GYNECARE TVT EXACT CONTINENCE SYSTEM K132054 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ethicon, Inc.. Cleared Aug 2013. https://www.510kdatabase.net/den130013/ 2013-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/den130013-vitek-ms-fda-510k.jpg DEN130013 - VITEK MS DEN130013 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Aug 2013. https://www.510kdatabase.net/k130749/ 2013-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k130749-syngomr-general-fda-510k.jpg K130749 - SYNGO.MR GENERAL K130749 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 2013. https://www.510kdatabase.net/k131842/ 2013-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k131842-sterican-cannula-fda-510k.jpg K131842 - STERICAN CANNULA K131842 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Aug 2013. https://www.510kdatabase.net/k123604/ 2013-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k123604-abg-iii-monolithic-hip-stem-fda-510k.jpg K123604 - ABG III MONOLITHIC HIP STEM K123604 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Aug 2013. https://www.510kdatabase.net/k130160/ 2013-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k130160-verify-process-indicator-for-reliance-fda-510k.jpg K130160 - VERIFY PROCESS INDICATOR FOR RELIANCE EPS K130160 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Aug 2013. https://www.510kdatabase.net/k131634/ 2013-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k131634-symbia-fda-510k.jpg K131634 - SYMBIA K131634 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 2013. https://www.510kdatabase.net/k132334/ 2013-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k132334-turbo-ject-peripherally-inserted-fda-510k.jpg K132334 - TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) SET K132334 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cook, Inc.. Cleared Aug 2013. https://www.510kdatabase.net/k130392/ 2013-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k130392-kinex-bioactive-fda-510k.jpg K130392 - KINEX BIOACTIVE K130392 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Aug 2013. https://www.510kdatabase.net/k132341/ 2013-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k132341-dc-8-dc-8-pro-dc-8-cv-dc-8-exp-dc-8s-fda-510k.jpg K132341 - DC-8/ DC-8 PRO/ DC-8 CV/ DC-8 EXP/ DC-8S DIAGNOSTIC ULTRASOUND SYSTEMS K132341 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Aug 2013. https://www.510kdatabase.net/k131536/ 2013-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k131536-immulite-2000-psa-calibration-fda-510k.jpg K131536 - IMMULITE 2000 PSA CALIBRATION VERIFICATION MATERIAL K131536 is a FDA 510(k) cleared immunology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Aug 2013. https://www.510kdatabase.net/k123553/ 2013-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k123553-zimmer-ats-4000ts-automatic-tourniquet-fda-510k.jpg K123553 - ZIMMER A.T.S. 4000TS AUTOMATIC TOURNIQUET SYSTEM K123553 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Zimmer, Inc.. Cleared Aug 2013. https://www.510kdatabase.net/k130484/ 2013-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k130484-maxforce-biliary-dilatation-catheter-fda-510k.jpg K130484 - MAXFORCE BILIARY DILATATION CATHETER AND HURRICANE RX BILIARY CATHETER K130484 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Aug 2013. https://www.510kdatabase.net/k130126/ 2013-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k130126-signature-personalized-patient-care-fda-510k.jpg K130126 - SIGNATURE PERSONALIZED PATIENT CARE SYSTEM - GLENOID GUIDE SYSTEM K130126 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Aug 2013. https://www.510kdatabase.net/k130748/ 2013-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k130748-smith-nephew-sureshot-distal-targeting-fda-510k.jpg K130748 - SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V3.0 K130748 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Aug 2013. https://www.510kdatabase.net/k131301/ 2013-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k131301-bd-facs-sample-prep-assistant-iii-fda-510k.jpg K131301 - BD FACS SAMPLE PREP ASSISTANT III K131301 is a FDA 510(k) cleared immunology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Aug 2013. https://www.510kdatabase.net/k131493/ 2013-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k131493-sidekick-and-usher-support-catheters-fda-510k.jpg K131493 - SIDEKICK AND USHER SUPPORT CATHETERS K131493 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Aug 2013. https://www.510kdatabase.net/k132043/ 2013-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k132043-arthrex-speedcinch-fda-510k.jpg K132043 - ARTHREX SPEEDCINCH K132043 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Arthrex, Inc.. Cleared Jul 2013. https://www.510kdatabase.net/k122532/ 2013-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k122532-da-vinci-single-site-instruments-and-fda-510k.jpg K122532 - DA VINCI SINGLE-SITE INSTRUMENTS AND ACCESSORIES K122532 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Jul 2013. https://www.510kdatabase.net/k131449/ 2013-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k131449-coalition-spacer-fda-510k.jpg K131449 - COALITION SPACER K131449 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Jul 2013. https://www.510kdatabase.net/k132008/ 2013-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k132008-6981m-lead-extender-kit-6984m-lead-fda-510k.jpg K132008 - 6981M LEAD EXTENDER KIT, 6984M LEAD EXTENDER KIT, 6986M LEAD EXTENDER KIT, 5866-24M LEAD ADAPTOR KIT, 5866-38M LEAD ADAP K132008 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Jul 2013. https://www.510kdatabase.net/k122091/ 2013-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k122091-cook-turbo-flo-hd-acute-hemodialysis-fda-510k.jpg K122091 - COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY K122091 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook, Inc.. Cleared Jul 2013. https://www.510kdatabase.net/k131710/ 2013-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k131710-merit-hydrophilic-guide-wire-fda-510k.jpg K131710 - MERIT HYDROPHILIC GUIDE WIRE K131710 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jul 2013. https://www.510kdatabase.net/k121445/ 2013-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k121445-tetrachrome-reagents-and-tetracxp-system-fda-510k.jpg K121445 - TETRACHROME REAGENTS AND TETRACXP SYSTEM K121445 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jul 2013. https://www.510kdatabase.net/k123768/ 2013-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k123768-reliance-advance-endoscope-processing-fda-510k.jpg K123768 - RELIANCE ADVANCE ENDOSCOPE PROCESSING SYSTEM K123768 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Jul 2013. https://www.510kdatabase.net/k130478/ 2013-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k130478-sustain-and-sustain-radiolucent-spacers-fda-510k.jpg K130478 - SUSTAIN AND SUSTAIN RADIOLUCENT SPACERS K130478 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Jul 2013. https://www.510kdatabase.net/k123714/ 2013-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k123714-edwards-embol-x-introducer-sheath-fda-510k.jpg K123714 - EDWARDS EMBOL-X INTRODUCER SHEATH K123714 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Jul 2013. https://www.510kdatabase.net/k131690/ 2013-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k131690-m7m7t-diagnostic-ultrasound-system-fda-510k.jpg K131690 - M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM K131690 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Jul 2013. https://www.510kdatabase.net/k131964/ 2013-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k131964-bio-console-560-extracorporeal-blood-fda-510k.jpg K131964 - BIO-CONSOLE 560 EXTRACORPOREAL BLOOD PUMPING CONSOLE K131964 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Jul 2013. https://www.510kdatabase.net/k131822/ 2013-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k131822-ultraextend-usws-900a-v21-and-v31-fda-510k.jpg K131822 - ULTRAEXTEND USWS-900A V2.1 AND V3.1 K131822 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Jul 2013. https://www.510kdatabase.net/k132062/ 2013-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k132062-esie-apps-suite-fda-510k.jpg K132062 - ESIE APPS SUITE K132062 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 2013. https://www.510kdatabase.net/k130766/ 2013-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k130766-roadrunner-uniglide-hydrophilic-wire-fda-510k.jpg K130766 - ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE K130766 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Jul 2013. https://www.510kdatabase.net/k131544/ 2013-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k131544-cobas-c-bilirubin-total-gen3-fda-510k.jpg K131544 - COBAS C BILIRUBIN TOTAL GEN.3 K131544 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Jul 2013. https://www.510kdatabase.net/k130536/ 2013-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k130536-export-advance-aspiration-catheter-fda-510k.jpg K130536 - EXPORT ADVANCE ASPIRATION CATHETER K130536 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Jul 2013. https://www.510kdatabase.net/k131120/ 2013-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k131120-amsco-v-pro-1-low-v-pro-1-plus-v-pro-fda-510k.jpg K131120 - AMSCO V-PRO 1 LOW, V-PRO 1 PLUS, V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM K131120 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Jul 2013. https://www.510kdatabase.net/k131358/ 2013-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k131358-bd-pen-needle-fda-510k.jpg K131358 - BD PEN NEEDLE K131358 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson & CO. Cleared Jul 2013. https://www.510kdatabase.net/k130253/ 2013-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k130253-tq-prep-workstation-prepplus-2-fda-510k.jpg K130253 - TQ-PREP WORKSTATION, PREPPLUS 2 WORKSTATION K130253 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jul 2013. https://www.510kdatabase.net/den110006/ 2013-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/den110006-verify-cronos-self-contained-fda-510k.jpg DEN110006 - VERIFY CRONOS SELF-CONTAINED BIOLOGICAL INDICATOR DEN110006 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Jul 2013. https://www.510kdatabase.net/k130391/ 2013-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k130391-emerge-monorail-ptca-dilatation-fda-510k.jpg K130391 - EMERGE MONORAIL PTCA DILATATION CATHETER, EMERGE PUSH MONORAIL PTCA DILATATION CATHETER, EMERGE OVER-THE-WIRE PTCA DILAT K130391 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Jul 2013. https://www.510kdatabase.net/k131269/ 2013-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k131269-dlp-coronary-ostial-perfusion-cannulae-fda-510k.jpg K131269 - DLP CORONARY OSTIAL PERFUSION CANNULAE K131269 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Jul 2013. https://www.510kdatabase.net/k131331/ 2013-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k131331-bd-phoenix-automated-microbiology-fda-510k.jpg K131331 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN (0.5-32 UG/ML) K131331 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Jul 2013. https://www.510kdatabase.net/k131078/ 2013-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k131078-system-1e-liquid-chemical-sterilant-fda-510k.jpg K131078 - SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM K131078 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Jul 2013. https://www.510kdatabase.net/k131283/ 2013-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k131283-prophecy-infinity-preoperative-fda-510k.jpg K131283 - PROPHECY INFINITY PREOPERATIVE NAVIGATION ALIGNMENT GUIDES K131283 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jul 2013. https://www.510kdatabase.net/k123074/ 2013-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k123074-imec-ipm-and-beneview-t1-patient-fda-510k.jpg K123074 - IMEC, IPM AND BENEVIEW T1 PATIENT MONITORS K123074 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Jul 2013. https://www.510kdatabase.net/k130376/ 2013-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k130376-dynasty-acetabular-system-with-ceramic-fda-510k.jpg K130376 - DYNASTY ACETABULAR SYSTEM WITH CERAMIC K130376 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jul 2013. https://www.510kdatabase.net/k131474/ 2013-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k131474-arthrex-distal-radius-plate-system-fda-510k.jpg K131474 - ARTHREX DISTAL RADIUS PLATE SYSTEM K131474 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jul 2013. https://www.510kdatabase.net/k131575/ 2013-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k131575-exactech-equinox-superiorposterior-fda-510k.jpg K131575 - EXACTECH EQUINOX SUPERIOR/POSTERIOR AUGMENT REVERSE SHOULDER GLENOID BASEPLATE - LEFT & RIGHT K131575 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Jul 2013. https://www.510kdatabase.net/k131670/ 2013-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k131670-lapidus-plate-35mm-inline-fusion-plate-fda-510k.jpg K131670 - LAPIDUS PLATE, 3.5MM INLINE FUSION PLATE, 3.5MM MTP PLATE (LEFT AND RIGHT) K131670 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jul 2013. https://www.510kdatabase.net/k131002/ 2013-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k131002-vida-ptv-dilataton-catheter-fda-510k.jpg K131002 - VIDA PTV DILATATON CATHETER K131002 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jul 2013. https://www.510kdatabase.net/k124030/ 2013-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k124030-cook-holmium-laser-fiber-fda-510k.jpg K124030 - COOK HOLMIUM LASER FIBER K124030 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cook Incorporated. Cleared Jul 2013. https://www.510kdatabase.net/k122917/ 2013-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k122917-coda-balloon-catheter-fda-510k.jpg K122917 - CODA BALLOON CATHETER K122917 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Jun 2013. https://www.510kdatabase.net/k123598/ 2013-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k123598-smith-nephew-inc-hip-system-fda-510k.jpg K123598 - SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATION K123598 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jun 2013. https://www.510kdatabase.net/k123404/ 2013-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k123404-bd-phoenix-automated-microbiology-fda-510k.jpg K123404 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- IMIPENEM (0.0625-32 UG/ML) K123404 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Jun 2013. https://www.510kdatabase.net/k122983/ 2013-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k122983-ksea-bipolar-electrode-fda-510k.jpg K122983 - KSEA BIPOLAR ELECTRODE K122983 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jun 2013. https://www.510kdatabase.net/k130833/ 2013-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k130833-dp-20-digital-ultrasonic-diagnostic-fda-510k.jpg K130833 - DP-20 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM K130833 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Jun 2013. https://www.510kdatabase.net/k130566/ 2013-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k130566-basixtouch-fda-510k.jpg K130566 - BASIXTOUCH K130566 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jun 2013. https://www.510kdatabase.net/k130695/ 2013-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k130695-z5-diagnostic-ultrasound-system-fda-510k.jpg K130695 - Z5 DIAGNOSTIC ULTRASOUND SYSTEM K130695 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Jun 2013. https://www.510kdatabase.net/k131267/ 2013-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k131267-voluson-e6e8e8experte8expert-limited-fda-510k.jpg K131267 - VOLUSON E6/E8/E8EXPERT/E8EXPERT LIMITED EDITION/E10 K131267 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Jun 2013. https://www.510kdatabase.net/k121214/ 2013-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k121214-access-accutni3-reagent-and-access-fda-510k.jpg K121214 - ACCESS ACCUTNI+3 REAGENT AND ACCESS ACCUTN1+3 CALIBRATORS FOR USE ON THE ACCESS 2 IMMUNOASSAY SYSTEM K121214 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jun 2013. https://www.510kdatabase.net/k130992/ 2013-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k130992-pinnacle3-radiation-therapy-planning-fda-510k.jpg K130992 - PINNACLE3 RADIATION THERAPY PLANNING SYSTEM K130992 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Jun 2013. https://www.510kdatabase.net/k123520/ 2013-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k123520-mammomat-inspiration-prime-fda-510k.jpg K123520 - MAMMOMAT INSPIRATION PRIME K123520 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 2013. https://www.510kdatabase.net/k130259/ 2013-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k130259-bearing-nspva-embolization-particles-fda-510k.jpg K130259 - BEARING NSPVA EMBOLIZATION PARTICLES K130259 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jun 2013. https://www.510kdatabase.net/k130726/ 2013-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k130726-da-vinci-single-site-permanent-cautery-fda-510k.jpg K130726 - DA VINCI SINGLE-SITE PERMANENT CAUTERY HOOK K130726 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Jun 2013. https://www.510kdatabase.net/k130791/ 2013-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k130791-prelude-sheath-introducer-fda-510k.jpg K130791 - PRELUDE SHEATH INTRODUCER K130791 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jun 2013. https://www.510kdatabase.net/k130739/ 2013-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k130739-acuson-s2000-and-s3000-diagnostic-fda-510k.jpg K130739 - ACUSON S2000 AND S3000 DIAGNOSTIC ULTRASOUND SYSTEMS K130739 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 2013. https://www.510kdatabase.net/k130382/ 2013-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k130382-heartstring-iii-proximal-seal-system-fda-510k.jpg K130382 - HEARTSTRING III PROXIMAL SEAL SYSTEM K130382 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Jun 2013. https://www.510kdatabase.net/k122791/ 2013-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k122791-lyoplant-onlay-fda-510k.jpg K122791 - LYOPLANT ONLAY K122791 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Jun 2013. https://www.510kdatabase.net/k130640/ 2013-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k130640-atlantis-anterior-cervical-plate-system-fda-510k.jpg K130640 - ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM K130640 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Jun 2013. https://www.510kdatabase.net/k130129/ 2013-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k130129-univers-revers-shoulder-prosthesis-fda-510k.jpg K130129 - UNIVERS REVERS SHOULDER PROSTHESIS SYSTEM K130129 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared May 2013. https://www.510kdatabase.net/k130293/ 2013-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k130293-advance-18lp-low-profile-pta-balloon-fda-510k.jpg K130293 - ADVANCE 18LP LOW PROFILE PTA BALLOON DILATATION CATHETER K130293 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared May 2013. https://www.510kdatabase.net/k130319/ 2013-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k130319-medline-cannulated-screw-fda-510k.jpg K130319 - MEDLINE CANNULATED SCREW K130319 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medline Industries, Inc.. Cleared May 2013. https://www.510kdatabase.net/k130984/ 2013-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k130984-profemur-renaissance-classic-hip-stem-fda-510k.jpg K130984 - PROFEMUR RENAISSANCE CLASSIC HIP STEM K130984 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared May 2013. https://www.510kdatabase.net/den130002/ 2013-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/den130002-tina-quant-hba1c-gen-2-test-system-fda-510k.jpg DEN130002 - TINA-QUANT HBA1C GEN. 2 TEST SYSTEM DEN130002 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared May 2013. https://www.510kdatabase.net/k130444/ 2013-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k130444-h-30-holmium-laser-system-fda-510k.jpg K130444 - H-30 HOLMIUM LASER SYSTEM K130444 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cook, Inc.. Cleared May 2013. https://www.510kdatabase.net/k130804/ 2013-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k130804-uromax-ultra-balloon-dilatation-catheter-fda-510k.jpg K130804 - UROMAX ULTRA BALLOON DILATATION CATHETER K130804 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared May 2013. https://www.510kdatabase.net/k123726/ 2013-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k123726-cobas-8000-ise-indirect-na-k-ci-for-fda-510k.jpg K123726 - COBAS 8000 ISE INDIRECT NA, K, CI FOR GEN. 2 K123726 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared May 2013. https://www.510kdatabase.net/k130077/ 2013-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k130077-remstar-se-fda-510k.jpg K130077 - REMSTAR SE K130077 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared May 2013. https://www.510kdatabase.net/k131093/ 2013-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k131093-ortholocr-3di-ankle-plating-system-fda-510k.jpg K131093 - ORTHOLOC(R) 3DI ANKLE PLATING SYSTEM K131093 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared May 2013. https://www.510kdatabase.net/k121976/ 2013-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k121976-aesculap-histoacryl-flexible-topical-fda-510k.jpg K121976 - AESCULAP HISTOACRYL FLEXIBLE TOPICAL SKIN ADHESIVE K121976 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared May 2013. https://www.510kdatabase.net/k123510/ 2013-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k123510-magnetom-skyra-fda-510k.jpg K123510 - MAGNETOM SKYRA K123510 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 2013. https://www.510kdatabase.net/k130885/ 2013-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k130885-magnetom-avanto-fit-magnetom-skyra-fit-fda-510k.jpg K130885 - MAGNETOM AVANTO-FIT, MAGNETOM SKYRA-FIT K130885 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 2013. https://www.510kdatabase.net/k122644/ 2013-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k122644-artis-zeezeego-with-csx-10-detector-sw-fda-510k.jpg K122644 - ARTIS ZEE/ZEEGO WITH CSX-10 DETECTOR SW VC21 K122644 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 2013. https://www.510kdatabase.net/k130909/ 2013-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k130909-gateway-advanage-y-adapter-fda-510k.jpg K130909 - GATEWAY ADVANAGE Y-ADAPTER K130909 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared May 2013. https://www.510kdatabase.net/k131118/ 2013-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k131118-4d-view-fda-510k.jpg K131118 - 4D VIEW K131118 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared May 2013. https://www.510kdatabase.net/k130366/ 2013-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k130366-bard-denali-filter-system-femoral-fda-510k.jpg K130366 - BARD DENALI FILTER SYSTEM- FEMORAL DELIVERY KIT AND JUGULAR DELIVERY KIT K130366 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 2013. https://www.510kdatabase.net/k130479/ 2013-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k130479-ilizarov-drill-tip-wires-fda-510k.jpg K130479 - ILIZAROV DRILL TIP WIRES K130479 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared May 2013. https://www.510kdatabase.net/k123903/ 2013-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k123903-bactec-lytic10-anaerobicf-culture-fda-510k.jpg K123903 - BACTEC Lytic/10 Anaerobic/F Culture Vials (plastic) K123903 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared May 2013. https://www.510kdatabase.net/k123913/ 2013-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k123913-latis-spacer-fda-510k.jpg K123913 - LATIS SPACER K123913 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared May 2013. https://www.510kdatabase.net/k124058/ 2013-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k124058-creo-stabilization-system-fda-510k.jpg K124058 - CREO STABILIZATION SYSTEM K124058 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared May 2013. https://www.510kdatabase.net/k130661/ 2013-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k130661-zimmer-trabecular-metal-reverse-fda-510k.jpg K130661 - ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM K130661 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared May 2013. https://www.510kdatabase.net/k123095/ 2013-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k123095-medline-blood-pressure-transducer-fda-510k.jpg K123095 - MEDLINE BLOOD PRESSURE TRANSDUCER K123095 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medline Industries, Inc.. Cleared May 2013. https://www.510kdatabase.net/k122923/ 2013-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k122923-quanta-flash-ena7-fda-510k.jpg K122923 - QUANTA FLASH ENA7 K122923 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared May 2013. https://www.510kdatabase.net/k123159/ 2013-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k123159-smith-newphew-inc-disposable-knee-fda-510k.jpg K123159 - SMITH & NEWPHEW, INC. DISPOSABLE KNEE INSTRUMENTS K123159 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared May 2013. https://www.510kdatabase.net/k130458/ 2013-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k130458-knotless-fibertak-suture-anchor-fda-510k.jpg K130458 - KNOTLESS FIBERTAK SUTURE ANCHOR K130458 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared May 2013. https://www.510kdatabase.net/k130786/ 2013-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k130786-sleek-otw-pta-catheter-fda-510k.jpg K130786 - SLEEK OTW PTA CATHETER K130786 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 2013. https://www.510kdatabase.net/k130434/ 2013-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k130434-octane-straight-octane-straight-fda-510k.jpg K130434 - OCTANE STRAIGHT, OCTANE STRAIGHT - LORDOTIC, OCTANE STRAIGHT I/R, OCTANE STRAIGHT I/R - LORDOTIC K130434 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared May 2013. https://www.510kdatabase.net/k130968/ 2013-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k130968-ventralight-st-mesh-with-echo-ps-fda-510k.jpg K130968 - VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM K130968 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 2013. https://www.510kdatabase.net/k122225/ 2013-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k122225-sterile-radiolucent-skull-pins-fda-510k.jpg K122225 - STERILE RADIOLUCENT SKULL PINS K122225 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Apr 2013. https://www.510kdatabase.net/k123990/ 2013-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k123990-sentrant-introducer-sheath-with-fda-510k.jpg K123990 - SENTRANT INTRODUCER SHEATH WITH HYDROPHILIC COATING K123990 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Apr 2013. https://www.510kdatabase.net/k122381/ 2013-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k122381-nexfin-model-2-fda-510k.jpg K122381 - NEXFIN MODEL 2 K122381 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Apr 2013. https://www.510kdatabase.net/k130063/ 2013-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k130063-arcos-trochanter-button-fda-510k.jpg K130063 - ARCOS TROCHANTER BUTTON K130063 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Apr 2013. https://www.510kdatabase.net/k130167/ 2013-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k130167-profemur-xm-distal-centralizer-fda-510k.jpg K130167 - PROFEMUR XM DISTAL CENTRALIZER K130167 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Apr 2013. https://www.510kdatabase.net/k130335/ 2013-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k130335-mastergraft-strip-fda-510k.jpg K130335 - MASTERGRAFT STRIP K130335 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Apr 2013. https://www.510kdatabase.net/k123593/ 2013-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k123593-quanta-flash-sm-quanta-flash-rnp-fda-510k.jpg K123593 - QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP CALIBRATORS, QUANTA FLASH SM CONTROLS, K123593 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Apr 2013. https://www.510kdatabase.net/k123621/ 2013-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k123621-opticross-40-mhz-coronary-imaging-fda-510k.jpg K123621 - OPTICROSS 40 MHZ CORONARY IMAGING CATHETER K123621 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Apr 2013. https://www.510kdatabase.net/k123393/ 2013-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k123393-healicoil-suture-anchor-with-regenesorb-fda-510k.jpg K123393 - HEALICOIL SUTURE ANCHOR WITH REGENESORB K123393 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Apr 2013. https://www.510kdatabase.net/k130121/ 2013-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k130121-short-port-blunt-tip-trocar-fda-510k.jpg K130121 - SHORT PORT BLUNT TIP TROCAR K130121 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Boston Scientific Corporation. Cleared Apr 2013. https://www.510kdatabase.net/k130646/ 2013-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k130646-cd-horizon-spinal-system-fda-510k.jpg K130646 - CD HORIZON SPINAL SYSTEM K130646 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Apr 2013. https://www.510kdatabase.net/k130215/ 2013-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k130215-gore-acuseal-vascular-graft-fda-510k.jpg K130215 - GORE ACUSEAL VASCULAR GRAFT K130215 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Apr 2013. https://www.510kdatabase.net/k123089/ 2013-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k123089-freestyle-auto-assist-software-verson-fda-510k.jpg K123089 - FREESTYLE AUTO-ASSIST SOFTWARE VERSON 2.0 WITH MODEL PRT24238-001 K123089 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Apr 2013. https://www.510kdatabase.net/k123241/ 2013-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k123241-arthrex-fracture-plates-fda-510k.jpg K123241 - ARTHREX FRACTURE PLATES K123241 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Apr 2013. https://www.510kdatabase.net/k130044/ 2013-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k130044-sidekick-ez-frame-external-fixation-fda-510k.jpg K130044 - SIDEKICK EZ FRAME EXTERNAL FIXATION SYSTEM K130044 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Apr 2013. https://www.510kdatabase.net/k130069/ 2013-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k130069-innova-epvision-20-innova-epvision-20-fda-510k.jpg K130069 - INNOVA EPVISION 2.0, INNOVA EPVISION 2.0 K130069 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Apr 2013. https://www.510kdatabase.net/k130588/ 2013-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k130588-merit-hydrophilic-guide-wire-fda-510k.jpg K130588 - MERIT HYDROPHILIC GUIDE WIRE K130588 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Apr 2013. https://www.510kdatabase.net/k121576/ 2013-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k121576-immulite-2000-anti-ccp-igg-assay-fda-510k.jpg K121576 - IMMULITE 2000 ANTI-CCP IGG ASSAY K121576 is a FDA 510(k) cleared immunology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Apr 2013. https://www.510kdatabase.net/k130423/ 2013-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k130423-the-richard-wolf-endocam-logic-hd-fda-510k.jpg K130423 - THE RICHARD WOLF ENDOCAM LOGIC HD CAMERA SYSTEM 5525 K130423 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Apr 2013. https://www.510kdatabase.net/k123733/ 2013-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k123733-cardioblate-cryoflex-surgical-ablation-fda-510k.jpg K123733 - CARDIOBLATE CRYOFLEX SURGICAL ABLATION SYSTEM K123733 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Apr 2013. https://www.510kdatabase.net/k123906/ 2013-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k123906-vertex-reconstruction-system-vertext-fda-510k.jpg K123906 - VERTEX RECONSTRUCTION SYSTEM, VERTEXT SELECT RECONSTRUCTION SYSTEM K123906 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Apr 2013. https://www.510kdatabase.net/k123954/ 2013-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k123954-infinity-total-ankle-system-fda-510k.jpg K123954 - INFINITY TOTAL ANKLE SYSTEM K123954 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Apr 2013. https://www.510kdatabase.net/k123762/ 2013-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k123762-dlp-retrograde-coronary-sinus-fda-510k.jpg K123762 - DLP RETROGRADE CORONARY SINUS PERFUSION CANNULA WITH AUTO-INFLATE CUFF K123762 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Mar 2013. https://www.510kdatabase.net/k113871/ 2013-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k113871-pro-dense-bone-graft-substitute-fda-510k.jpg K113871 - PRO-DENSE BONE GRAFT SUBSTITUTE K113871 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Mar 2013. https://www.510kdatabase.net/k122584/ 2013-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k122584-hemosil-readiplas-tin-fda-510k.jpg K122584 - HEMOSIL READIPLAS TIN K122584 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Mar 2013. https://www.510kdatabase.net/k120771/ 2013-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k120771-unicel-dxh-800-coulter-cellular-fda-510k.jpg K120771 - UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM K120771 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Mar 2013. https://www.510kdatabase.net/k123303/ 2013-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k123303-femoral-access-venous-cannulae-fda-510k.jpg K123303 - FEMORAL ACCESS VENOUS CANNULAE K123303 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Mar 2013. https://www.510kdatabase.net/k130276/ 2013-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k130276-dimension-exl-with-lm-system-fda-510k.jpg K130276 - DIMENSION EXL WITH LM SYSTEM K130276 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Mar 2013. https://www.510kdatabase.net/k130596/ 2013-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k130596-caiman-seal-and-cut-technology-fda-510k.jpg K130596 - CAIMAN SEAL AND CUT TECHNOLOGY K130596 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Mar 2013. https://www.510kdatabase.net/k122218/ 2013-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k122218-advance-total-knee-system-patella-fda-510k.jpg K122218 - ADVANCE TOTAL KNEE SYSTEM-PATELLA K122218 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Mar 2013. https://www.510kdatabase.net/k130619/ 2013-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k130619-acuson-s1000-diagnostic-ultrasound-fda-510k.jpg K130619 - ACUSON S1000 DIAGNOSTIC ULTRASOUND SYSTEM K130619 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2013. https://www.510kdatabase.net/k121655/ 2013-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k121655-bd-alcohol-swab-fda-510k.jpg K121655 - BD ALCOHOL SWAB K121655 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson & CO. Cleared Mar 2013. https://www.510kdatabase.net/k123687/ 2013-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k123687-optetrak-logic-porous-femoral-component-fda-510k.jpg K123687 - OPTETRAK LOGIC POROUS FEMORAL COMPONENT K123687 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Mar 2013. https://www.510kdatabase.net/k122940/ 2013-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k122940-advance-micro-14-ultra-low-profile-fda-510k.jpg K122940 - ADVANCE MICRO 14 ULTRA LOW PROFILE BALLOON DILATATION CATHETER MODEL PTA3 K122940 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Mar 2013. https://www.510kdatabase.net/k122059/ 2013-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k122059-all-suture-anchor-twist-drill-for-all-fda-510k.jpg K122059 - ALL-SUTURE ANCHOR TWIST DRILL FOR ALL-SUTURE ANCHORS INLINE DRILL GUIDE FOR ALL-SUTURE ANCHORS K122059 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Mar 2013. https://www.510kdatabase.net/k123546/ 2013-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k123546-3m-attesttm-auto-reader-fda-510k.jpg K123546 - 3M ATTEST(TM) AUTO-READER K123546 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Mar 2013. https://www.510kdatabase.net/k121593/ 2013-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k121593-3m-attest-tm-super-radid-readout-steam-fda-510k.jpg K121593 - 3M ATTEST (TM) SUPER RADID READOUT STEAM CHALLENGE PACK 3M ATTEST(TM) SUPER RAPID 5 STEAM-PLUS CHALLENGE PACK K121593 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Mar 2013. https://www.510kdatabase.net/k123298/ 2013-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k123298-fem-felx-fex-flex-ii-femoral-access-fda-510k.jpg K123298 - FEM-FELX, FEX-FLEX II FEMORAL ACCESS CANNULA WITH DURAFLO COATING K123298 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Mar 2013. https://www.510kdatabase.net/k130138/ 2013-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k130138-super-sani-cloth-accu-chek-inform-ii-fda-510k.jpg K130138 - SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM K130138 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Mar 2013. https://www.510kdatabase.net/k122534/ 2013-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k122534-immulite-1000-third-generation-psa-fda-510k.jpg K122534 - IMMULITE 1000 THIRD GENERATION PSA CALIBRATION VERIFICATION MATERIAL K122534 is a FDA 510(k) cleared immunology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Mar 2013. https://www.510kdatabase.net/k123783/ 2013-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k123783-ellipse-occipito-cerico-thoracic-fda-510k.jpg K123783 - ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM AND CAPITOL IMPLANTS K123783 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Mar 2013. https://www.510kdatabase.net/k123933/ 2013-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k123933-microscan-dried-gram-positive-miccombo-fda-510k.jpg K123933 - MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - CEFTAROLINE K123933 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Mar 2013. https://www.510kdatabase.net/k123948/ 2013-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k123948-china-nails-and-accessories-fda-510k.jpg K123948 - CHINA NAILS AND ACCESSORIES K123948 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Mar 2013. https://www.510kdatabase.net/k123370/ 2013-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k123370-ez-glide-aortic-cannula-aortic-fda-510k.jpg K123370 - EZ GLIDE AORTIC CANNULA, AORTIC PERFUSION CANNULA WITH DURAFLO COATING, DISPERSION AORTIC PERFUSION CANNULA K123370 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Mar 2013. https://www.510kdatabase.net/k130251/ 2013-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k130251-esophagus-bougie-set-fda-510k.jpg K130251 - ESOPHAGUS BOUGIE SET K130251 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Mar 2013. https://www.510kdatabase.net/k123584/ 2013-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k123584-syngo-ct-bone-reading-fda-510k.jpg K123584 - SYNGO, CT BONE READING K123584 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2013. https://www.510kdatabase.net/k123862/ 2013-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k123862-zimmer-nexel-total-elbow-fda-510k.jpg K123862 - ZIMMER NEXEL TOTAL ELBOW K123862 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Mar 2013. https://www.510kdatabase.net/k123815/ 2013-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k123815-surface-applicator-set-with-leipzig-fda-510k.jpg K123815 - SURFACE APPLICATOR SET WITH LEIPZIG-STYLE CONE K123815 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Mar 2013. https://www.510kdatabase.net/k122847/ 2013-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k122847-kangaroo-nasal-mask-fda-510k.jpg K122847 - KANGAROO NASAL MASK K122847 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Mar 2013. https://www.510kdatabase.net/k123059/ 2013-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k123059-inbone-i-and-ii-total-ankle-systems-fda-510k.jpg K123059 - INBONE ( I AND II) TOTAL ANKLE SYSTEMS K123059 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Mar 2013. https://www.510kdatabase.net/k123812/ 2013-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k123812-coherence-rt-therapist-connect-fda-510k.jpg K123812 - COHERENCE RT THERAPIST CONNECT WORKSPACE, V2.3, ARIA CONNECTIVITY OPTION FOR SIEMENS NON-IMAGING SYSTEMS, ARIA CONNECTIV K123812 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2013. https://www.510kdatabase.net/k130243/ 2013-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k130243-ilab-ultrasound-imaging-system-fda-510k.jpg K130243 - ILAB ULTRASOUND IMAGING SYSTEM K130243 is a FDA 510(k) cleared radiology medical device. Manufacturer: Boston Scientific Corp. Cleared Mar 2013. https://www.510kdatabase.net/k130245/ 2013-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k130245-large-bore-stopcock-with-rotating-male-fda-510k.jpg K130245 - LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO K130245 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 2013. https://www.510kdatabase.net/k130262/ 2013-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k130262-magnetom-essenza-with-syngo-mr-d14-fda-510k.jpg K130262 - MAGNETOM ESSENZA WITH SYNGO MR D14 K130262 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2013. https://www.510kdatabase.net/k123679/ 2013-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k123679-3m-tegaderm-chg-chlorhexidine-fda-510k.jpg K123679 - 3M TEGADERM CHG CHLORHEXIDINE GLUCONATE I.V. PORT DRESSING K123679 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3M Company. Cleared Feb 2013. https://www.510kdatabase.net/k123707/ 2013-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k123707-alight-16-superselective-microwire-guide-fda-510k.jpg K123707 - ALIGHT 16 SUPERSELECTIVE MICROWIRE GUIDE K123707 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Feb 2013. https://www.510kdatabase.net/k123965/ 2013-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k123965-cobas-integra-bilirubin-direct-gen2-fda-510k.jpg K123965 - COBAS INTEGRA BILIRUBIN DIRECT GEN.2 K123965 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Feb 2013. https://www.510kdatabase.net/k123501/ 2013-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k123501-oss-modular-stems-oss-diaphyseal-fda-510k.jpg K123501 - OSS MODULAR STEMS, OSS DIAPHYSEAL SEGMENTS K123501 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Feb 2013. https://www.510kdatabase.net/k120817/ 2013-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k120817-quanta-flash-acl-lga-quanta-flash-fda-510k.jpg K120817 - QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA K120817 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Feb 2013. https://www.510kdatabase.net/k123529/ 2013-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k123529-artis-q-and-qzen-modular-angiographic-fda-510k.jpg K123529 - ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM K123529 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 2013. https://www.510kdatabase.net/k123656/ 2013-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k123656-vertex-reconstruction-system-vertex-fda-510k.jpg K123656 - VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM K123656 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Feb 2013. https://www.510kdatabase.net/k122015/ 2013-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k122015-distal-femoral-growing-prosthesis-fda-510k.jpg K122015 - DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE K122015 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Feb 2013. https://www.510kdatabase.net/k122286/ 2013-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k122286-mammomal-inspiration-fda-510k.jpg K122286 - MAMMOMAL INSPIRATION K122286 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 2013. https://www.510kdatabase.net/k123187/ 2013-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k123187-retrograde-coronary-sinus-cardioplegia-fda-510k.jpg K123187 - RETROGRADE CORONARY SINUS CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CATHETER, RETROGRADE CARDIOPLEGIA CANNULA K123187 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Feb 2013. https://www.510kdatabase.net/k123459/ 2013-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k123459-zimmer-persona-tm-personalized-knee-fda-510k.jpg K123459 - ZIMMER PERSONA TM PERSONALIZED KNEE SYSTEM K123459 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Feb 2013. https://www.510kdatabase.net/k123615/ 2013-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k123615-iris-high-strength-glass-ceramic-fda-510k.jpg K123615 - IRIS - HIGH STRENGTH GLASS CERAMIC K123615 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Feb 2013. https://www.510kdatabase.net/k123809/ 2013-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k123809-cd-horizon-spinal-system-fda-510k.jpg K123809 - CD HORIZON SPINAL SYSTEM K123809 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Feb 2013. https://www.510kdatabase.net/k130143/ 2013-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k130143-persona-natural-tibia-baseplates-fda-510k.jpg K130143 - PERSONA NATURAL TIBIA BASEPLATES K130143 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Feb 2013. https://www.510kdatabase.net/k123424/ 2013-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k123424-mdu5-plus-sterile-bag-fda-510k.jpg K123424 - MDU5 PLUS STERILE BAG K123424 is a FDA 510(k) cleared radiology medical device. Manufacturer: Boston Scientific Corp. Cleared Feb 2013. https://www.510kdatabase.net/k123425/ 2013-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k123425-twinfix-ti-35mm-suture-anchor-with-two-fda-510k.jpg K123425 - TWINFIX TI 3.5MM SUTURE ANCHOR WITH TWO ULTRABRAID SUTURE #2 WITH NEEDLES, SL K123425 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Feb 2013. https://www.510kdatabase.net/k123166/ 2013-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k123166-triathlon-all-polyethylene-condylar-fda-510k.jpg K123166 - TRIATHLON ALL-POLYETHYLENE CONDYLAR STABILIZING (CS) TIBIAL IMPLANTS TRIATHLON ALL-POLYETHYLENE POSTERIOR STABILIZING (P K123166 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Feb 2013. https://www.510kdatabase.net/k123235/ 2013-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k123235-equaflow-multivalve-infusion-catheter-fda-510k.jpg K123235 - EQUAFLOW MULTIVALVE INFUSION CATHETER K123235 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Feb 2013. https://www.510kdatabase.net/k123840/ 2013-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k123840-connect-for-da-vinci-surgical-systems-fda-510k.jpg K123840 - CONNECT FOR DA VINCI SURGICAL SYSTEM(S) K123840 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Feb 2013. https://www.510kdatabase.net/k123918/ 2013-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k123918-motionloc-screw-for-ncb-polyaxial-fda-510k.jpg K123918 - MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATE SYSTEM K123918 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Feb 2013. https://www.510kdatabase.net/k123097/ 2013-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k123097-dose-tracking-system-model-xidf-dts801-fda-510k.jpg K123097 - DOSE TRACKING SYSTEM MODEL XIDF-DTS801 K123097 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Feb 2013. https://www.510kdatabase.net/k113614/ 2013-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k113614-accu-check-compact-plus-blood-glucose-fda-510k.jpg K113614 - ACCU-CHECK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM K113614 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Feb 2013. https://www.510kdatabase.net/k121877/ 2013-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k121877-gibralt-occipital-plate-screws-set-fda-510k.jpg K121877 - GIBRALT OCCIPITAL PLATE SCREWS, SET SCREW, GIBRALT OCCIPITAL SYSTEM ARTICULATING ROD, GIBRALT OCCIPITAL PLATES K121877 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Feb 2013. https://www.510kdatabase.net/k123938/ 2013-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k123938-syngo-mr-b19-for-magnetom-avanto-syngo-fda-510k.jpg K123938 - SYNGO MR B19 FOR MAGNETOM AVANTO, SYNGO MR B19 FOR MAGNETOM ESPREE, SYNGO MR B19 FOR MAGNETOM SYMPHONY A TIM SYSTEM, SYN K123938 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 2013. https://www.510kdatabase.net/k121069/ 2013-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k121069-3m-vflex-health-care-particulate-fda-510k.jpg K121069 - 3M VFLEX HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK K121069 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Feb 2013. https://www.510kdatabase.net/k123688/ 2013-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k123688-profemur-tl-classic-hip-stem-fda-510k.jpg K123688 - PROFEMUR TL CLASSIC HIP STEM K123688 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Feb 2013. https://www.510kdatabase.net/k121050/ 2013-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k121050-09-sodium-chloride-injection-usp-bd-fda-510k.jpg K121050 - 0.9% SODIUM CHLORIDE INJECTION USP BD POSIFLUSH FLUSH SYRINGE, SF FLUSH SYRINGE K121050 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson & CO. Cleared Feb 2013. https://www.510kdatabase.net/k123114/ 2013-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k123114-ethicon-securestrap-open-absorbable-fda-510k.jpg K123114 - ETHICON SECURESTRAP OPEN ABSORBABLE STRAP FIXATION DEVICE K123114 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Feb 2013. https://www.510kdatabase.net/k123434/ 2013-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k123434-profemur-z-classic-stems-fda-510k.jpg K123434 - PROFEMUR Z CLASSIC STEMS K123434 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Feb 2013. https://www.510kdatabase.net/k121985/ 2013-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k121985-architect-total-bilirubin-fda-510k.jpg K121985 - ARCHITECT TOTAL BILIRUBIN K121985 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Feb 2013. https://www.510kdatabase.net/k122853/ 2013-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k122853-novel-fit-and-fill-stem-fda-510k.jpg K122853 - NOVEL FIT AND FILL STEM K122853 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Feb 2013. https://www.510kdatabase.net/k123420/ 2013-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k123420-syngo-breast-care-fda-510k.jpg K123420 - SYNGO, BREAST CARE K123420 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 2013. https://www.510kdatabase.net/k113353/ 2013-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k113353-gemini-sterilzation-wrap-fda-510k.jpg K113353 - GEMINI STERILZATION WRAP K113353 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Jan 2013. https://www.510kdatabase.net/k123358/ 2013-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k123358-pacific-plus-fda-510k.jpg K123358 - PACIFIC PLUS K123358 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jan 2013. https://www.510kdatabase.net/k123737/ 2013-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k123737-biograph-mct-family-fda-510k.jpg K123737 - BIOGRAPH MCT FAMILY K123737 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 2013. https://www.510kdatabase.net/k121446/ 2013-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k121446-bactalert-pf-plus-culture-bottle-fda-510k.jpg K121446 - BACT/ALERT PF PLUS CULTURE BOTTLE K121446 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jan 2013. https://www.510kdatabase.net/k121455/ 2013-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k121455-bactalert-fn-plus-culture-bottle-fda-510k.jpg K121455 - BACT/ALERT FN PLUS CULTURE BOTTLE K121455 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jan 2013. https://www.510kdatabase.net/k123055/ 2013-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k123055-smith-nephew-inc-screw-and-plate-fda-510k.jpg K123055 - SMITH & NEPHEW, INC SCREW AND PLATE SYSTEM INSTRUMENTATION K123055 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jan 2013. https://www.510kdatabase.net/k123560/ 2013-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k123560-vascular-occlusion-system-trufill-fda-510k.jpg K123560 - VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUFILL DCS ORBIT DETACHABLE COIL SYSEM K123560 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Jan 2013. https://www.510kdatabase.net/k123956/ 2013-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k123956-power-led-175-fda-510k.jpg K123956 - POWER LED 175 K123956 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jan 2013. https://www.510kdatabase.net/k123579/ 2013-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k123579-footprint-ultra-pk45mm-and-55mm-suture-fda-510k.jpg K123579 - FOOTPRINT ULTRA PK4.5MM AND 5.5MM SUTURE ANCHOR, SL K123579 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jan 2013. https://www.510kdatabase.net/k121461/ 2013-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k121461-bactalert-fa-plus-culture-bottle-fda-510k.jpg K121461 - BACT/ALERT FA PLUS CULTURE BOTTLE K121461 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jan 2013. https://www.510kdatabase.net/k123314/ 2013-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k123314-affinity-fusion-oxygenator-with-fda-510k.jpg K123314 - AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND CARMEDA BIOACTIVE SURFACE K123314 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Jan 2013. https://www.510kdatabase.net/k123577/ 2013-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k123577-syngovia-mi-workflows-fda-510k.jpg K123577 - SYNGO.VIA MI WORKFLOWS K123577 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 2013. https://www.510kdatabase.net/k123718/ 2013-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k123718-permasorb-disposable-fixation-device-fda-510k.jpg K123718 - PERMASORB DISPOSABLE FIXATION DEVICE K123718 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 2013. https://www.510kdatabase.net/k123231/ 2013-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k123231-caliber-spacers-fda-510k.jpg K123231 - CALIBER SPACERS K123231 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Jan 2013. https://www.510kdatabase.net/k123300/ 2013-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k123300-bd-pen-needle-fda-510k.jpg K123300 - BD PEN NEEDLE K123300 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson & CO. Cleared Jan 2013. https://www.510kdatabase.net/k121392/ 2013-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k121392-novation-crown-cup-liners-fda-510k.jpg K121392 - NOVATION CROWN CUP LINERS K121392 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Jan 2013. https://www.510kdatabase.net/k123609/ 2013-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k123609-merit-hydrophilic-guide-wire-fda-510k.jpg K123609 - MERIT HYDROPHILIC GUIDE WIRE K123609 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jan 2013. https://www.510kdatabase.net/k123922/ 2013-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k123922-syngo-dynamics-fda-510k.jpg K123922 - SYNGO DYNAMICS K123922 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 2013. https://www.510kdatabase.net/k123535/ 2013-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k123535-ilab-ultrasound-imaging-system-fda-510k.jpg K123535 - ILAB ULTRASOUND IMAGING SYSTEM K123535 is a FDA 510(k) cleared radiology medical device. Manufacturer: Boston Scientific Corp. Cleared Jan 2013. https://www.510kdatabase.net/k123788/ 2013-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k123788-integrated-collimator-verification-and-fda-510k.jpg K123788 - INTEGRATED COLLIMATOR VERIFICATION AND INTERLOCK SYSTEM (ICVI) K123788 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Jan 2013. https://www.510kdatabase.net/k123372/ 2013-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k123372-abbott-lipid-multi-constituent-fda-510k.jpg K123372 - ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR K123372 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jan 2013. https://www.510kdatabase.net/k123270/ 2013-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k123270-powerease-system-fda-510k.jpg K123270 - POWEREASE SYSTEM K123270 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Jan 2013. https://www.510kdatabase.net/k123342/ 2013-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k123342-optetrak-logic-crc-tibial-insert-fda-510k.jpg K123342 - OPTETRAK LOGIC CRC TIBIAL INSERT K123342 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Jan 2013. https://www.510kdatabase.net/k123874/ 2013-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k123874-interlink-system-buretrol-solution-fda-510k.jpg K123874 - INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL S K123874 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jan 2013. https://www.510kdatabase.net/k123911/ 2013-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k123911-senomark-ultra-breast-tissue-marker-fda-510k.jpg K123911 - SENOMARK ULTRA BREAST TISSUE MARKER K123911 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 2013. https://www.510kdatabase.net/k122914/ 2013-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k122914-affinity-fusion-cardiotomyvenous-fda-510k.jpg K122914 - AFFINITY FUSION CARDIOTOMY/VENOUS RESERVIOR WITH BALANCE BIOSURFACE MODEL BB841, AFFINITY FUSION CARDIOTOMY/ VENOUS RESE K122914 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Jan 2013. https://www.510kdatabase.net/k123213/ 2013-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k123213-bd-phaseal-closed-system-transfer-device-fda-510k.jpg K123213 - BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE K123213 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson & CO. Cleared Jan 2013. https://www.510kdatabase.net/k123868/ 2013-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k123868-interlink-system-lever-lock-cannula-fda-510k.jpg K123868 - INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET K123868 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jan 2013. https://www.510kdatabase.net/k123102/ 2013-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k123102-sovereign-mini-fda-510k.jpg K123102 - SOVEREIGN MINI K123102 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Jan 2013. https://www.510kdatabase.net/k123712/ 2013-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k123712-retracta-detachable-embolization-coil-fda-510k.jpg K123712 - RETRACTA DETACHABLE EMBOLIZATION COIL K123712 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Jan 2013. https://www.510kdatabase.net/k122457/ 2013-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k122457-ge-innovainnova-igsdiscovery-igsoptima-fda-510k.jpg K122457 - GE INNOVA/INNOVA IGS/DISCOVERY IGS/OPTIMA ANGIOGRAPHIC, FLUOSCOPIC X-RAY SYSTEMS WITH CATHLAB FRONTIERS SOLUTIONS K122457 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Jan 2013. https://www.510kdatabase.net/k122111/ 2012-12-31 monthly 0.5 https://www.510kdatabase.net/og-image/k122111-respironics-simplyclear-device-fda-510k.jpg K122111 - RESPIRONICS SIMPLYCLEAR DEVICE K122111 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Dec 2012. https://www.510kdatabase.net/k121003/ 2012-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k121003-abbott-plex-id-flu-assay-fda-510k.jpg K121003 - ABBOTT PLEX-ID FLU ASSAY K121003 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Dec 2012. https://www.510kdatabase.net/k123341/ 2012-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k123341-arthrex-pec-repair-button-arthrex-fda-510k.jpg K123341 - ARTHREX PEC REPAIR BUTTON, ARTHREX LARGE PEC BUTTON, ARTHREX BICEPS BUTTON, ARTHREX PROXIMAL BICEPS BUTTON K123341 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Dec 2012. https://www.510kdatabase.net/k123046/ 2012-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k123046-advia-chemistry-lipoproteina-reagent-fda-510k.jpg K123046 - ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR K123046 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Dec 2012. https://www.510kdatabase.net/k123085/ 2012-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k123085-futuro-tm-travel-knee-highs-fda-510k.jpg K123085 - FUTURO (TM) TRAVEL KNEE-HIGHS K123085 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Dec 2012. https://www.510kdatabase.net/k123291/ 2012-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k123291-truebeam-fda-510k.jpg K123291 - TRUEBEAM K123291 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Dec 2012. https://www.510kdatabase.net/k123528/ 2012-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k123528-scenium-fda-510k.jpg K123528 - SCENIUM K123528 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Dec 2012. https://www.510kdatabase.net/k123585/ 2012-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k123585-syngo-ct-cardiac-function-fda-510k.jpg K123585 - SYNGO, CT CARDIAC FUNCTION K123585 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Dec 2012. https://www.510kdatabase.net/k122734/ 2012-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k122734-aesculap-novosyn-absorbable-suture-fda-510k.jpg K122734 - AESCULAP NOVOSYN ABSORBABLE SUTURE K122734 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Dec 2012. https://www.510kdatabase.net/k122794/ 2012-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k122794-upsylon-y-mesh-fda-510k.jpg K122794 - UPSYLON Y MESH K122794 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Boston Scientific Corp. Cleared Dec 2012. https://www.510kdatabase.net/k123564/ 2012-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k123564-logiq-e9-diagnostic-ultrasound-system-fda-510k.jpg K123564 - LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM K123564 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Dec 2012. https://www.510kdatabase.net/k123568/ 2012-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k123568-vertex-reconstruction-system-fda-510k.jpg K123568 - VERTEX RECONSTRUCTION SYSTEM K123568 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Dec 2012. https://www.510kdatabase.net/k121623/ 2012-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k121623-bipap-a-40-ventilatory-support-system-fda-510k.jpg K121623 - BIPAP A 40 VENTILATORY SUPPORT SYSTEM K121623 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Dec 2012. https://www.510kdatabase.net/k121955/ 2012-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k121955-coughassist-t70-device-fda-510k.jpg K121955 - COUGHASSIST T70 DEVICE K121955 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Dec 2012. https://www.510kdatabase.net/k122827/ 2012-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k122827-affinity-fusion-oxygenator-with-fda-510k.jpg K122827 - AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND BALANCE BIOSURFACE MODEL BB811 K122827 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Dec 2012. https://www.510kdatabase.net/k122937/ 2012-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k122937-slip-cath-beacon-tip-catheter-model-fda-510k.jpg K122937 - SLIP-CATH BEACON TIP CATHETER MODEL SCBR (PRODUCT PREFIX), SHUTTLE SELECT SLIP-CATH CATHETER MODEL SCBR (PRODUCT PREFIX) K122937 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Dec 2012. https://www.510kdatabase.net/k122459/ 2012-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k122459-pinnacle-lite-pelvic-floor-repair-kit-fda-510k.jpg K122459 - PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM K122459 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Boston Scientific Corporation. Cleared Dec 2012. https://www.510kdatabase.net/k122613/ 2012-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k122613-vantage-titan-with-helios-gradient-fda-510k.jpg K122613 - VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/US K122613 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Dec 2012. https://www.510kdatabase.net/k123156/ 2012-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k123156-gore-flow-reversal-system-model-gfrs073-fda-510k.jpg K123156 - GORE FLOW REVERSAL SYSTEM MODEL GFRS073 K123156 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Dec 2012. https://www.510kdatabase.net/k123448/ 2012-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k123448-affinity-flexible-luer-lock-adapter-fda-510k.jpg K123448 - AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVE K123448 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Dec 2012. https://www.510kdatabase.net/k123503/ 2012-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k123503-dc-n3dc-ns3-diagnostic-ultrasound-system-fda-510k.jpg K123503 - DC-N3/DC-NS3 DIAGNOSTIC ULTRASOUND SYSTEM K123503 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Dec 2012. https://www.510kdatabase.net/k122649/ 2012-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k122649-navigator-hd-ureteral-access-sheath-set-fda-510k.jpg K122649 - NAVIGATOR HD URETERAL ACCESS SHEATH SET K122649 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Dec 2012. https://www.510kdatabase.net/k122760/ 2012-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k122760-affinity-af100-arterial-filter-with-fda-510k.jpg K122760 - AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE K122760 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Dec 2012. https://www.510kdatabase.net/k120770/ 2012-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k120770-qt-guard-plus-analysis-system-fda-510k.jpg K120770 - QT GUARD PLUS ANALYSIS SYSTEM K120770 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Dec 2012. https://www.510kdatabase.net/k121067/ 2012-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k121067-exactech-equinoxe-shoulder-system-fda-510k.jpg K121067 - EXACTECH EQUINOXE SHOULDER SYSTEM TORQUE DEFINING SCREW AND SHORT REPLICATOR PLATE K121067 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Dec 2012. https://www.510kdatabase.net/k122097/ 2012-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k122097-patriot-spacers-fda-510k.jpg K122097 - PATRIOT SPACERS K122097 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Dec 2012. https://www.510kdatabase.net/k122088/ 2012-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k122088-merit-one-snare-system-fda-510k.jpg K122088 - MERIT ONE SNARE SYSTEM K122088 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Dec 2012. https://www.510kdatabase.net/k122242/ 2012-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k122242-elecsys-ca-15-3-ii-calcheck-5-fda-510k.jpg K122242 - ELECSYS CA 15-3 II CALCHECK 5 K122242 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics. Cleared Dec 2012. https://www.510kdatabase.net/k122745/ 2012-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k122745-zimmer-persona-the-personalized-knee-fda-510k.jpg K122745 - ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM K122745 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Dec 2012. https://www.510kdatabase.net/k123622/ 2012-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k123622-acuson-fda-510k.jpg K123622 - ACUSON K123622 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Dec 2012. https://www.510kdatabase.net/k122660/ 2012-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k122660-resolution-clip-model-m00522600-fda-510k.jpg K122660 - RESOLUTION CLIP MODEL M00522600, M00522601, M00522602, M00522610, M00522611, M00522612 K122660 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Dec 2012. https://www.510kdatabase.net/k122692/ 2012-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k122692-zimmer-trabecular-metal-reverse-fda-510k.jpg K122692 - ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, NON-POROUS HUMERAL STEMS K122692 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Dec 2012. https://www.510kdatabase.net/k123463/ 2012-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k123463-intuitive-surgical-da-vinci-si-fda-510k.jpg K123463 - INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM SMARTPEDALS K123463 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Dec 2012. https://www.510kdatabase.net/k121994/ 2012-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k121994-dimension-vista-vitamin-b12-vb12-flex-fda-510k.jpg K121994 - DIMENSION VISTA VITAMIN B12 (VB12) FLEX REAGENT CARTRIDGE, DIMENSION VISTA LOCI 4 CALIBRATOR K121994 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Nov 2012. https://www.510kdatabase.net/k122722/ 2012-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k122722-cobas-c-tina-quant-lipoprotein-a-gen-2-fda-510k.jpg K122722 - COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190 K122722 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Nov 2012. https://www.510kdatabase.net/k121989/ 2012-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k121989-optecure-bone-void-filler-05-cc-1cc-fda-510k.jpg K121989 - OPTECURE BONE VOID FILLER (0.5 CC, 1CC, 2CC, 5CC, 10CC, AND 20CC), OPTECURE + CCC BONE VOID FILLER (1CC, 2CC, 5CC, 10CC, K121989 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Nov 2012. https://www.510kdatabase.net/k123379/ 2012-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k123379-abbott-architect-free-t4-fda-510k.jpg K123379 - ABBOTT ARCHITECT FREE T4 K123379 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Nov 2012. https://www.510kdatabase.net/k121220/ 2012-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k121220-equinoxe-glenoid-uhmwpe-16-psosterior-fda-510k.jpg K121220 - EQUINOXE GLENOID, UHMWPE 16 PS=OSTERIOR AUGMENT PEGGED, SMALL, LEFT/RIGHT K121220 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Nov 2012. https://www.510kdatabase.net/k121234/ 2012-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k121234-gorer-dryseal-sheath-with-hydrophilic-fda-510k.jpg K121234 - GORE(R) DRYSEAL SHEATH WITH HYDROPHILIC COATING K121234 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Nov 2012. https://www.510kdatabase.net/k121546/ 2012-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k121546-vitek-2-gram-negative-doxycycline-fda-510k.jpg K121546 - VITEK 2 GRAM NEGATIVE DOXYCYCLINE K121546 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Nov 2012. https://www.510kdatabase.net/k121846/ 2012-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k121846-contiplex-c-continuous-peripheral-fda-510k.jpg K121846 - CONTIPLEX C CONTINUOUS PERIPHERAL NERVE BLOCK NEEDLE K121846 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Nov 2012. https://www.510kdatabase.net/k122467/ 2012-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k122467-3m-true-definition-scanner-fda-510k.jpg K122467 - 3M TRUE DEFINITION SCANNER K122467 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Nov 2012. https://www.510kdatabase.net/k122596/ 2012-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k122596-arthroscopic-surgical-instruments-fda-510k.jpg K122596 - ARTHROSCOPIC SURGICAL INSTRUMENTS - INTERFERENCE SCREW SYSTEMS K122596 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Nov 2012. https://www.510kdatabase.net/k121100/ 2012-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k121100-vitek-2-ast-streptococus-vancomycin-fda-510k.jpg K121100 - VITEK 2 AST STREPTOCOCUS VANCOMYCIN K121100 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Nov 2012. https://www.510kdatabase.net/k122236/ 2012-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k122236-varisourse-ix-brahytherapy-afterloader-fda-510k.jpg K122236 - VARISOURSE IX BRAHYTHERAPY AFTERLOADER VARISOURCE IX (T) BRACHYTHERAPY AFTERLOADER K122236 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Nov 2012. https://www.510kdatabase.net/k122529/ 2012-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k122529-zimmer-unicompartmental-knee-system-fda-510k.jpg K122529 - ZIMMER UNICOMPARTMENTAL KNEE SYSTEM VIVACIT-E ARTICULAR SURFACE K122529 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Nov 2012. https://www.510kdatabase.net/k123174/ 2012-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k123174-centricity-pacs-iw-with-universal-viewer-fda-510k.jpg K123174 - CENTRICITY PACS-IW WITH UNIVERSAL VIEWER K123174 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Nov 2012. https://www.510kdatabase.net/k123246/ 2012-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k123246-cd-horizon-spire-z-spinal-system-fda-510k.jpg K123246 - CD HORIZON SPIRE Z SPINAL SYSTEM K123246 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Nov 2012. https://www.510kdatabase.net/k113380/ 2012-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k113380-prostiva-rf-therapy-hand-piece-fda-510k.jpg K113380 - PROSTIVA RF THERAPY HAND PIECE PROSTIVA RF THERAPY RF GENERATOR K113380 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medtronic, Inc.. Cleared Nov 2012. https://www.510kdatabase.net/k122011/ 2012-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k122011-navigation-software-hip-universal-fda-510k.jpg K122011 - NAVIGATION SOFTWARE HIP-UNIVERSAL K122011 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Brainlab AG. Cleared Nov 2012. https://www.510kdatabase.net/k122899/ 2012-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k122899-powerport-clearvue-slim-implantable-port-fda-510k.jpg K122899 - POWERPORT CLEARVUE SLIM IMPLANTABLE PORT K122899 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 2012. https://www.510kdatabase.net/k123214/ 2012-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k123214-encore-26-advantage-kit-fda-510k.jpg K123214 - ENCORE 26 ADVANTAGE KIT K123214 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Nov 2012. https://www.510kdatabase.net/k122765/ 2012-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k122765-persona-natural-tibia-baseplates-fda-510k.jpg K122765 - PERSONA NATURAL TIBIA BASEPLATES K122765 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Nov 2012. https://www.510kdatabase.net/k121771/ 2012-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k121771-zimmer-persona-the-personalized-knee-fda-510k.jpg K121771 - ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM K121771 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Nov 2012. https://www.510kdatabase.net/k122187/ 2012-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k122187-vreselect-culture-medium-fda-510k.jpg K122187 - VRESELECT CULTURE MEDIUM K122187 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bio-Rad. Cleared Nov 2012. https://www.510kdatabase.net/k121200/ 2012-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k121200-flightplan-for-liver-fda-510k.jpg K121200 - FLIGHTPLAN FOR LIVER K121200 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Nov 2012. https://www.510kdatabase.net/k121878/ 2012-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k121878-cardioblate-cryoflex-surgical-ablation-fda-510k.jpg K121878 - CARDIOBLATE CRYOFLEX SURGICAL ABLATION PROBES K121878 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Nov 2012. https://www.510kdatabase.net/k122367/ 2012-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k122367-bard-ptv-dilatation-catheter-fda-510k.jpg K122367 - BARD PTV DILATATION CATHETER K122367 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 2012. https://www.510kdatabase.net/k122436/ 2012-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k122436-composix-lp-mesh-with-echo-ps-fda-510k.jpg K122436 - COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM K122436 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 2012. https://www.510kdatabase.net/k123179/ 2012-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k123179-ajust-helical-adjustable-single-fda-510k.jpg K123179 - AJUST HELICAL ADJUSTABLE SINGLE-INCISION SLING K123179 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 2012. https://www.510kdatabase.net/k123185/ 2012-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k123185-dc-8dc-8-prodc-8-cvdc-8-expdc-8s-fda-510k.jpg K123185 - DC-8/DC-8 PRO/DC-8, CV/DC-8, EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEM K123185 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Nov 2012. https://www.510kdatabase.net/k121315/ 2012-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k121315-stryker-cmf-medpor-customized-implant-fda-510k.jpg K121315 - STRYKER CMF MEDPOR CUSTOMIZED IMPLANT K121315 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Nov 2012. https://www.510kdatabase.net/k121732/ 2012-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k121732-canopy-laminoplasty-fixation-system-fda-510k.jpg K121732 - CANOPY LAMINOPLASTY FIXATION SYSTEM K121732 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Oct 2012. https://www.510kdatabase.net/k122395/ 2012-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k122395-depuy-agility-lp-total-ankle-prosthesis-fda-510k.jpg K122395 - DEPUY AGILITY LP TOTAL ANKLE PROSTHESIS K122395 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Oct 2012. https://www.510kdatabase.net/k123001/ 2012-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k123001-acuson-x700-diagnstic-ultrasound-system-fda-510k.jpg K123001 - ACUSON X700 DIAGNSTIC ULTRASOUND SYSTEM K123001 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 2012. https://www.510kdatabase.net/k123024/ 2012-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k123024-torque-device-fda-510k.jpg K123024 - TORQUE DEVICE K123024 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Oct 2012. https://www.510kdatabase.net/k121921/ 2012-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k121921-intuitive-surgical-onsite-for-da-vinci-fda-510k.jpg K121921 - INTUITIVE SURGICAL ONSITE FOR DA VINCI SURGICAL SYSTEMS K121921 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Oct 2012. https://www.510kdatabase.net/k122924/ 2012-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k122924-cre-fixed-wire-ballon-dilation-catheter-fda-510k.jpg K122924 - CRE FIXED WIRE BALLON DILATION CATHETER K122924 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Oct 2012. https://www.510kdatabase.net/k123012/ 2012-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k123012-smith-nephew-smf-hip-stem-fda-510k.jpg K123012 - SMITH & NEPHEW SMF HIP STEM K123012 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 2012. https://www.510kdatabase.net/k120728/ 2012-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k120728-phasix-plug-and-patch-fda-510k.jpg K120728 - PHASIX PLUG AND PATCH K120728 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 2012. https://www.510kdatabase.net/k122382/ 2012-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k122382-dynasty-biofoam-shell-fda-510k.jpg K122382 - DYNASTY BIOFOAM SHELL K122382 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Oct 2012. https://www.510kdatabase.net/k122984/ 2012-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k122984-atlas-gold-pta-dilatation-catheter-fda-510k.jpg K122984 - ATLAS GOLD PTA DILATATION CATHETER K122984 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 2012. https://www.510kdatabase.net/k123019/ 2012-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k123019-longevity-it-highly-crosslinked-fda-510k.jpg K123019 - LONGEVITY IT HIGHLY CROSSLINKED POLYETHYENE LINERS K123019 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Oct 2012. https://www.510kdatabase.net/k121484/ 2012-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k121484-3m-attesttm-super-rapid-readout-fda-510k.jpg K121484 - 3M ATTEST(TM) SUPER RAPID READOUT BIOLOGICAL INDICATOR, 3M ATTEST(TM) AUTO-READER K121484 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Oct 2012. https://www.510kdatabase.net/k122170/ 2012-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k122170-smith-nephew-inc-intramedullary-nail-fda-510k.jpg K122170 - SMITH & NEPHEW, INC. INTRAMEDULLARY NAIL SYSTEM INSTRUMENTATION K122170 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 2012. https://www.510kdatabase.net/k122913/ 2012-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k122913-affinity-fusion-recirculation-line-fda-510k.jpg K122913 - AFFINITY FUSION RECIRCULATION LINE MODEL RCL841 K122913 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Oct 2012. https://www.510kdatabase.net/k121861/ 2012-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k121861-smith-nephew-ultra-fast-fix-meniscal-fda-510k.jpg K121861 - SMITH & NEPHEW ULTRA FAST-FIX MENISCAL REPAIR SYSTEM, SMITH & NEPHEW ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEM, SMITH & N K121861 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 2012. https://www.510kdatabase.net/k113706/ 2012-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k113706-endowrist-stapler-system-fda-510k.jpg K113706 - ENDOWRIST STAPLER SYSTEM K113706 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Oct 2012. https://www.510kdatabase.net/k122139/ 2012-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k122139-smith-nephew-r3-constrained-liners-fda-510k.jpg K122139 - SMITH & NEPHEW R3 CONSTRAINED LINERS K122139 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 2012. https://www.510kdatabase.net/k121627/ 2012-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k121627-smith-nephew-redapt-revision-femoral-fda-510k.jpg K121627 - SMITH & NEPHEW REDAPT REVISION FEMORAL SYSTEM K121627 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 2012. https://www.510kdatabase.net/k122547/ 2012-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k122547-gram-postitve-clindamycin-fda-510k.jpg K122547 - GRAM POSTITVE CLINDAMYCIN K122547 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Oct 2012. https://www.510kdatabase.net/k120199/ 2012-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k120199-glycosylated-hemoglobin-assay-fda-510k.jpg K120199 - GLYCOSYLATED HEMOGLOBIN ASSAY K120199 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Oct 2012. https://www.510kdatabase.net/k121002/ 2012-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k121002-etest-ceftaroline-fda-510k.jpg K121002 - ETEST CEFTAROLINE K121002 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Oct 2012. https://www.510kdatabase.net/k121651/ 2012-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k121651-ortholoc-3di-midfootflatfoot-system-fda-510k.jpg K121651 - ORTHOLOC 3DI MIDFOOT/FLATFOOT SYSTEM K121651 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Oct 2012. https://www.510kdatabase.net/k122398/ 2012-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k122398-rapidpoint-500-system-measurement-fda-510k.jpg K122398 - RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORS K122398 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Oct 2012. https://www.510kdatabase.net/k122811/ 2012-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k122811-connector-components-with-balance-fda-510k.jpg K122811 - CONNECTOR COMPONENTS WITH BALANCE BIOSURFACE K122811 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Oct 2012. https://www.510kdatabase.net/k121543/ 2012-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k121543-zimmer-trabecular-metal-reverse-fda-510k.jpg K121543 - ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, BASE PLATES & HUMERAL STEMS K121543 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Oct 2012. https://www.510kdatabase.net/k121679/ 2012-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k121679-accu-chek-inform-ii-blood-glucose-fda-510k.jpg K121679 - ACCU-CHEK INFORM II BLOOD GLUCOSE MONITORING SYSTEM K121679 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Oct 2012. https://www.510kdatabase.net/k122778/ 2012-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k122778-profemur-z-revision-hip-stem-fda-510k.jpg K122778 - PROFEMUR Z REVISION HIP STEM K122778 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Oct 2012. https://www.510kdatabase.net/k122796/ 2012-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k122796-cxi-support-catheter-fda-510k.jpg K122796 - CXI SUPPORT CATHETER K122796 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Oct 2012. https://www.510kdatabase.net/k122798/ 2012-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k122798-integrip-acetabular-shell-integrip-fda-510k.jpg K122798 - INTEGRIP ACETABULAR SHELL, INTEGRIP REVISION ACETABULAR SHELL K122798 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Oct 2012. https://www.510kdatabase.net/k121754/ 2012-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k121754-blue-sui-sling-fda-510k.jpg K121754 - BLUE SUI SLING K121754 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Oct 2012. https://www.510kdatabase.net/k121076/ 2012-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k121076-ultraextend-fx-ultrasound-workstation-fda-510k.jpg K121076 - ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGE K121076 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Oct 2012. https://www.510kdatabase.net/k122769/ 2012-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k122769-remstar-se-fda-510k.jpg K122769 - REMSTAR SE K122769 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Oct 2012. https://www.510kdatabase.net/k122842/ 2012-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k122842-radrex-i-sw-v400-model-drad-3000e-fda-510k.jpg K122842 - RADREX-I, SW V4.00 MODEL DRAD-3000E K122842 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Oct 2012. https://www.510kdatabase.net/k113039/ 2012-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k113039-smith-nephew-radiopaque-trial-necks-fda-510k.jpg K113039 - SMITH & NEPHEW RADIOPAQUE TRIAL NECKS K113039 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 2012. https://www.510kdatabase.net/k121631/ 2012-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k121631-simple-t-nasal-mask-fda-510k.jpg K121631 - SIMPLE T NASAL MASK K121631 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Oct 2012. https://www.510kdatabase.net/k122921/ 2012-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k122921-c1-6-d-ultrasound-transducer-fda-510k.jpg K122921 - C1-6-D ULTRASOUND TRANSDUCER K122921 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Oct 2012. https://www.510kdatabase.net/k122114/ 2012-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k122114-logiq-s7-expert-logiq-s7-pro-fda-510k.jpg K122114 - LOGIQ S7 EXPERT, LOGIQ S7 PRO K122114 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Oct 2012. https://www.510kdatabase.net/k122599/ 2012-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k122599-advia-chemistry-myoglobin-reagent-fda-510k.jpg K122599 - ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR K122599 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Oct 2012. https://www.510kdatabase.net/k122862/ 2012-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k122862-cd-horizon-spinal-system-fda-510k.jpg K122862 - CD HORIZON SPINAL SYSTEM K122862 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Oct 2012. https://www.510kdatabase.net/k121425/ 2012-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k121425-ortholoc-3di-ankle-fusion-plating-system-fda-510k.jpg K121425 - ORTHOLOC 3DI ANKLE FUSION PLATING SYSTEM K121425 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Oct 2012. https://www.510kdatabase.net/k121684/ 2012-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k121684-novation-lpi-prime-femoral-stem-fda-510k.jpg K121684 - NOVATION LPI PRIME FEMORAL STEM K121684 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Oct 2012. https://www.510kdatabase.net/k122226/ 2012-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k122226-revere-stabilization-system-fda-510k.jpg K122226 - REVERE STABILIZATION SYSTEM K122226 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Oct 2012. https://www.510kdatabase.net/k122072/ 2012-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k122072-wallflextm-biliary-rx-stent-system-fda-510k.jpg K122072 - WALLFLEXTM BILIARY RX STENT SYSTEM (UNCOVERED, PARTIALLY COVERED, AND FULLY COVERED) WALLFLEXTM BILIARY TRANSHEPATIC STE K122072 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Sep 2012. https://www.510kdatabase.net/k122451/ 2012-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k122451-exactrac-vero-fda-510k.jpg K122451 - EXACTRAC VERO K122451 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab AG. Cleared Sep 2012. https://www.510kdatabase.net/k122825/ 2012-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k122825-acuson-fda-510k.jpg K122825 - ACUSON K122825 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 2012. https://www.510kdatabase.net/k122096/ 2012-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k122096-karl-storz-navigationpanel-unit-npu-fda-510k.jpg K122096 - KARL STORZ NAVIGATIONPANEL UNIT (NPU) SYSTEM K122096 is a FDA 510(k) cleared neurology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Sep 2012. https://www.510kdatabase.net/k121219/ 2012-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k121219-attain-clarity-6225-venogram-balloon-fda-510k.jpg K121219 - ATTAIN CLARITY 6225 VENOGRAM BALLOON CATHETER K121219 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Sep 2012. https://www.510kdatabase.net/k122374/ 2012-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k122374-arthrex-suture-uhmwpe-fda-510k.jpg K122374 - ARTHREX SUTURE (UHMWPE) K122374 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Arthrex, Inc.. Cleared Sep 2012. https://www.510kdatabase.net/k122089/ 2012-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k122089-ostial-pro-stent-positioning-system-fda-510k.jpg K122089 - OSTIAL PRO STENT POSITIONING SYSTEM K122089 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Sep 2012. https://www.510kdatabase.net/k122109/ 2012-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k122109-aquilion-one-vision-v490-fda-510k.jpg K122109 - AQUILION ONE VISION, V4.90 K122109 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Sep 2012. https://www.510kdatabase.net/k122327/ 2012-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k122327-voluson-e6e8e8experte10-fda-510k.jpg K122327 - VOLUSON E6/E8/E8EXPERT/E10 K122327 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Sep 2012. https://www.510kdatabase.net/k113863/ 2012-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k113863-quanta-flash-dgp-iga-quanta-flash-dgp-fda-510k.jpg K113863 - QUANTA FLASH DGP IGA, QUANTA FLASH DGP IGG, QUANTA FLASH DGP IGA CALIBRATORS, QUANTA FLASH DGP IGG CALIBRATORS K113863 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Sep 2012. https://www.510kdatabase.net/k121724/ 2012-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k121724-endolight-led-11-endolightled-12-fda-510k.jpg K121724 - ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2 K121724 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Sep 2012. https://www.510kdatabase.net/k120644/ 2012-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k120644-merit-hydrophilic-guide-wire-fda-510k.jpg K120644 - MERIT HYDROPHILIC GUIDE WIRE K120644 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Sep 2012. https://www.510kdatabase.net/k121614/ 2012-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k121614-nephromax-high-pressure-nephrostomy-fda-510k.jpg K121614 - NEPHROMAX HIGH PRESSURE NEPHROSTOMY BALOON DILATATION CATHETER K121614 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Sep 2012. https://www.510kdatabase.net/k100645/ 2012-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k100645-affinity-pixie-oxygenation-system-with-fda-510k.jpg K100645 - AFFINITY PIXIE OXYGENATION SYSTEM WITH CARMEDA BIOACTIVE SURFACE OR BALANCE BIOSURFACE K100645 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Sep 2012. https://www.510kdatabase.net/k113296/ 2012-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k113296-zmr-hip-system-kwz-prosthesis-hip-fda-510k.jpg K113296 - ZMR HIP SYSTEM KWZ-PROSTHESIS, HIP, CONSTRAINED, CEMENTED OR UNCEMENTED, METAL/POLYMER K113296 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Sep 2012. https://www.510kdatabase.net/k121694/ 2012-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k121694-imager-ii-angiographic-catheter-fda-510k.jpg K121694 - IMAGER II ANGIOGRAPHIC CATHETER K121694 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Sep 2012. https://www.510kdatabase.net/k121774/ 2012-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k121774-rotablator-rotational-atherectomy-fda-510k.jpg K121774 - ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH PERIPHERAL ROTALINK PLUS K121774 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Sep 2012. https://www.510kdatabase.net/k122569/ 2012-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k122569-lava-ultimate-cadcam-restorative-for-fda-510k.jpg K122569 - LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC LAVA ULTIMATE CAD/CAM RESTORATIVE FOR E4D LAVA ULTIMATE IMPLANT CROWN RESTOR K122569 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Sep 2012. https://www.510kdatabase.net/k120009/ 2012-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k120009-testosterone-test-system-fda-510k.jpg K120009 - TESTOSTERONE TEST SYSTEM K120009 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Sep 2012. https://www.510kdatabase.net/k121492/ 2012-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k121492-unicel-dxc-synchron-systems-hemoglobin-fda-510k.jpg K121492 - UNICEL DXC SYNCHRON SYSTEMS HEMOGLOBIN ALC-(HBA1C-) REAGENT K121492 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Sep 2012. https://www.510kdatabase.net/k122387/ 2012-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k122387-voluson-p6-voluson-p8-fda-510k.jpg K122387 - VOLUSON P6, VOLUSON P8 K122387 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Sep 2012. https://www.510kdatabase.net/k122515/ 2012-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k122515-c2-9-d-ultrasound-transducer-fda-510k.jpg K122515 - C2-9-D ULTRASOUND TRANSDUCER K122515 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Sep 2012. https://www.510kdatabase.net/k112624/ 2012-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k112624-elecsys-he4-elecsys-he4-calset-elecsys-fda-510k.jpg K112624 - ELECSYS HE4, ELECSYS HE4 CALSET, ELECSYS PRECICONTROL HE4, ELECSYS HE4 CALCHECK 5 K112624 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics. Cleared Sep 2012. https://www.510kdatabase.net/k121714/ 2012-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k121714-smith-nephew-inc-shoulder-system-fda-510k.jpg K121714 - SMITH & NEPHEW, INC. SHOULDER SYSTEM INSTRUMENTS K121714 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Sep 2012. https://www.510kdatabase.net/k121196/ 2012-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k121196-emerge-ptca-dilatation-catheter-fda-510k.jpg K121196 - EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) K121196 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Aug 2012. https://www.510kdatabase.net/k122353/ 2012-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k122353-crainfix-2-titanium-clamp-system-fda-510k.jpg K122353 - CRAINFIX 2 TITANIUM CLAMP SYSTEM K122353 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Aug 2012. https://www.510kdatabase.net/k122394/ 2012-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k122394-rubicon-18-support-catheter-fda-510k.jpg K122394 - RUBICON 18 SUPPORT CATHETER K122394 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Aug 2012. https://www.510kdatabase.net/k121760/ 2012-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k121760-capstone-spinal-system-fda-510k.jpg K121760 - CAPSTONE SPINAL SYSTEM K121760 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Aug 2012. https://www.510kdatabase.net/k122296/ 2012-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k122296-sl-plus-mia-femoral-stems-with-tiha-fda-510k.jpg K122296 - SL-PLUS MIA FEMORAL STEMS WITH TI/HA COATING K122296 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Aug 2012. https://www.510kdatabase.net/k122359/ 2012-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k122359-vitek-2-strptococcus-ceftriaxone-fda-510k.jpg K122359 - VITEK 2 STRPTOCOCCUS CEFTRIAXONE K122359 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Aug 2012. https://www.510kdatabase.net/k120906/ 2012-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k120906-zimmer-trabecular-metal-total-ankle-fda-510k.jpg K120906 - ZIMMER TRABECULAR METAL TOTAL ANKLE K120906 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Aug 2012. https://www.510kdatabase.net/k121895/ 2012-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k121895-elecsys-hsv-2-igg-immunoassay-fda-510k.jpg K121895 - ELECSYS HSV-2 IGG IMMUNOASSAY K121895 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Diagnostics. Cleared Aug 2012. https://www.510kdatabase.net/k122244/ 2012-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k122244-polarcup-dual-mobility-system-fda-510k.jpg K122244 - POLARCUP DUAL MOBILITY SYSTEM K122244 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Aug 2012. https://www.510kdatabase.net/k121185/ 2012-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k121185-edwards-percutaneous-sheath-introducer-fda-510k.jpg K121185 - EDWARDS PERCUTANEOUS SHEATH INTRODUCER K121185 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Aug 2012. https://www.510kdatabase.net/k120008/ 2012-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k120008-medline-high-pressure-injection-tubing-fda-510k.jpg K120008 - MEDLINE HIGH PRESSURE INJECTION TUBING K120008 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medline Industries, Inc.. Cleared Aug 2012. https://www.510kdatabase.net/k122190/ 2012-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k122190-prelude-7f-short-sheath-introducer-fda-510k.jpg K122190 - PRELUDE 7F SHORT SHEATH INTRODUCER K122190 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Aug 2012. https://www.510kdatabase.net/k122203/ 2012-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k122203-truetome-fda-510k.jpg K122203 - TRUETOME K122203 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Aug 2012. https://www.510kdatabase.net/k121863/ 2012-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k121863-vitek-2-ast-st-cefotaxime-fda-510k.jpg K121863 - VITEK 2 AST-ST CEFOTAXIME K121863 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Aug 2012. https://www.510kdatabase.net/k120789/ 2012-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k120789-exactrac-x-ray-x-ray-fda-510k.jpg K120789 - EXACTRAC X-RAY X-RAY K120789 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab AG. Cleared Aug 2012. https://www.510kdatabase.net/k121776/ 2012-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k121776-agility-steerable-guidewire-neuroscout-fda-510k.jpg K121776 - AGILITY STEERABLE GUIDEWIRE NEUROSCOUT STEERABLE GUDIEWIRE K121776 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Aug 2012. https://www.510kdatabase.net/k121443/ 2012-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k121443-journey-ii-cr-knee-system-fda-510k.jpg K121443 - JOURNEY II CR KNEE SYSTEM K121443 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Aug 2012. https://www.510kdatabase.net/k121667/ 2012-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k121667-nc-quantum-apex-ptca-dilatation-fda-510k.jpg K121667 - NC QUANTUM APEX PTCA DILATATION CATHETER (MONORAIL) K121667 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Aug 2012. https://www.510kdatabase.net/k121221/ 2012-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k121221-profemur-z-revision-hip-stem-fda-510k.jpg K121221 - PROFEMUR Z REVISION HIP STEM K121221 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Aug 2012. https://www.510kdatabase.net/k113783/ 2012-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k113783-vitek-2-ast-gram-postive-penicillin-fda-510k.jpg K113783 - VITEK 2 AST- GRAM POSTIVE PENICILLIN FOR STREPTOCOCCUS PNEUMONIAE K113783 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Aug 2012. https://www.510kdatabase.net/k121393/ 2012-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k121393-smith-nephew-inc-total-knee-system-fda-510k.jpg K121393 - SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATION K121393 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Aug 2012. https://www.510kdatabase.net/k120898/ 2012-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k120898-keyport-system-includes-keyport-fda-510k.jpg K120898 - KEYPORT SYSTEM, INCLUDES: KEYPORT SILICONE SEALING INSERT 8850XXX KEYPORT TRUCAR 8850XX KEYPORT TROCAR 8850XX SEALING CA K120898 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Aug 2012. https://www.510kdatabase.net/k121048/ 2012-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k121048-ultraflex-tracheobronchial-stent-fda-510k.jpg K121048 - ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED K121048 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Boston Scientific Corp. Cleared Aug 2012. https://www.510kdatabase.net/k122118/ 2012-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k122118-hakim-programmable-and-precision-valve-fda-510k.jpg K122118 - HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM K122118 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Aug 2012. https://www.510kdatabase.net/k112545/ 2012-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k112545-quanta-flash-pr3-quanta-flash-mpo-fda-510k.jpg K112545 - QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM K112545 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Jul 2012. https://www.510kdatabase.net/k112818/ 2012-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k112818-vidas-d-dimer-exclusion-ii-dex2-fda-510k.jpg K112818 - VIDAS D-DIMER EXCLUSION II (DEX2) K112818 is a FDA 510(k) cleared hematology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jul 2012. https://www.510kdatabase.net/k121292/ 2012-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k121292-dynapbv-body-software-fda-510k.jpg K121292 - DYNAPBV BODY SOFTWARE K121292 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 2012. https://www.510kdatabase.net/k121308/ 2012-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k121308-hip-systems-fda-510k.jpg K121308 - HIP SYSTEMS K121308 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jul 2012. https://www.510kdatabase.net/k121544/ 2012-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k121544-dynasty-biofoam-shell-fda-510k.jpg K121544 - DYNASTY BIOFOAM SHELL K121544 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jul 2012. https://www.510kdatabase.net/k120926/ 2012-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k120926-endobeam-holmium-laser-fibers-fda-510k.jpg K120926 - ENDOBEAM HOLMIUM LASER FIBERS K120926 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jul 2012. https://www.510kdatabase.net/k113397/ 2012-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k113397-zeus-elisa-borrelia-vlse-1pepc10-fda-510k.jpg K113397 - ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM K113397 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Jul 2012. https://www.510kdatabase.net/k120993/ 2012-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k120993-gammamedplus-ix-brachytherapy-fda-510k.jpg K120993 - GAMMAMEDPLUS IX BRACHYTHERAPY AFTERLOADER, GAMMAMEDPLUS 3/24 IX BRACHYTHERAPY AFTERLOADER K120993 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Jul 2012. https://www.510kdatabase.net/k121922/ 2012-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k121922-beacon-stabilization-system-fda-510k.jpg K121922 - BEACON STABILIZATION SYSTEM K121922 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Jul 2012. https://www.510kdatabase.net/k121982/ 2012-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k121982-sovereign-spinal-system-fda-510k.jpg K121982 - SOVEREIGN SPINAL SYSTEM K121982 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Jul 2012. https://www.510kdatabase.net/k120625/ 2012-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k120625-elecsys-hsv-1-igg-immunoassay-elecsys-fda-510k.jpg K120625 - ELECSYS HSV-1 IGG IMMUNOASSAY ELECSYS PRECICONTROL HSV K120625 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Diagnostics. Cleared Jul 2012. https://www.510kdatabase.net/k120988/ 2012-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k120988-dlp-single-stage-venous-cannula-dlp-fda-510k.jpg K120988 - DLP SINGLE STAGE VENOUS CANNULA, DLP RIGHT ANGLE SINGLE STAGE VENOUS CANNULA, DLP SINGLE STAGE VENOUS CANNULA WITH RIGHT K120988 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Jul 2012. https://www.510kdatabase.net/k113546/ 2012-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k113546-elecsys-vitamin-d-assay-elecsys-fda-510k.jpg K113546 - ELECSYS VITAMIN D ASSAY ELECSYS VITAMIN D CALSET ELECSYS PRECICONTROL VARIA 3 ELECSYS VITAMIN D CALCHECK 5 K113546 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Jul 2012. https://www.510kdatabase.net/k113229/ 2012-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k113229-ventrio-light-hernia-patch-with-trm-fda-510k.jpg K113229 - VENTRIO LIGHT HERNIA PATCH WITH TRM ANTIMICROBIAL COATING K113229 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jul 2012. https://www.510kdatabase.net/k122010/ 2012-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k122010-z6-diagnostic-ultrasound-system-fda-510k.jpg K122010 - Z6 DIAGNOSTIC ULTRASOUND SYSTEM K122010 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Jul 2012. https://www.510kdatabase.net/k120211/ 2012-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k120211-sl-plus-standard-and-lateral-femoral-fda-510k.jpg K120211 - SL-PLUS STANDARD AND LATERAL FEMORAL STEM WITH TI/HA COATING K120211 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 2012. https://www.510kdatabase.net/k111353/ 2012-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k111353-accu-check-combo-system-fda-510k.jpg K111353 - ACCU-CHECK COMBO SYSTEM K111353 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Roche Diagnostics. Cleared Jul 2012. https://www.510kdatabase.net/k120562/ 2012-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k120562-performax-pediatric-ee-total-face-mask-fda-510k.jpg K120562 - PERFORMAX PEDIATRIC EE TOTAL FACE MASK K120562 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Jul 2012. https://www.510kdatabase.net/k121832/ 2012-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k121832-resolve-biliary-locking-drainage-fda-510k.jpg K121832 - RESOLVE BILIARY LOCKING DRAINAGE CATHETER K121832 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jul 2012. https://www.510kdatabase.net/k121160/ 2012-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k121160-magnetom-spectra-fda-510k.jpg K121160 - MAGNETOM SPECTRA K121160 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 2012. https://www.510kdatabase.net/k121767/ 2012-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k121767-cardioblate-gemini-surgical-ablation-fda-510k.jpg K121767 - CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE K121767 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Jul 2012. https://www.510kdatabase.net/k121856/ 2012-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k121856-ultraverse-014-and-018-pta-balloon-fda-510k.jpg K121856 - ULTRAVERSE 014 AND 018 PTA BALLOON DILATATION CATHETERS LINE EXTENSION K121856 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jul 2012. https://www.510kdatabase.net/k120639/ 2012-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k120639-performax-pediatric-se-total-face-mask-fda-510k.jpg K120639 - PERFORMAX PEDIATRIC SE TOTAL FACE MASK K120639 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Jul 2012. https://www.510kdatabase.net/k121807/ 2012-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k121807-v5ms-transducer-fda-510k.jpg K121807 - V5MS TRANSDUCER K121807 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 2012. https://www.510kdatabase.net/k120468/ 2012-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k120468-ncircler-nitinol-tipless-stone-fda-510k.jpg K120468 - NCIRCLE(R) NITINOL TIPLESS STONE EXTRACTOR NGAGE(R) NITINOL STONE EXTRACTOR K120468 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cook Incorporated. Cleared Jul 2012. https://www.510kdatabase.net/k121601/ 2012-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k121601-synthes-2735mm-variable-angle-lcp-fda-510k.jpg K121601 - SYNTHES 2.7/3.5MM VARIABLE ANGLE LCP ANKLE TRAUMA SYSTEM-ANTEROLATERAL DISTAL TIBIA PLATE K121601 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jul 2012. https://www.510kdatabase.net/k121680/ 2012-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k121680-cd-horizon-spinal-system-fda-510k.jpg K121680 - CD HORIZON SPINAL SYSTEM K121680 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Jul 2012. https://www.510kdatabase.net/k121107/ 2012-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k121107-fortify-integrated-corpectomy-spacers-fda-510k.jpg K121107 - FORTIFY INTEGRATED CORPECTOMY SPACERS, (FORTIFY I AND FORTIFY I-R) K121107 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Jul 2012. https://www.510kdatabase.net/k113200/ 2012-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k113200-vitek-2-ast-gn-piperacillintazobactam-fda-510k.jpg K113200 - VITEK 2 AST-GN PIPERACILLIN/TAZOBACTAM K113200 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jun 2012. https://www.510kdatabase.net/k113459/ 2012-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k113459-anteplegia-catheter-antegrade-fda-510k.jpg K113459 - ANTEPLEGIA CATHETER ANTEGRADE CARDIOPLEGIA CATHETER AORTIC ROOT CANNULA ANTEGRADE CATHETER WITH DURAFLO COATING K113459 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Jun 2012. https://www.510kdatabase.net/k120520/ 2012-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k120520-exactrac-robotics-novalis-robotics-fda-510k.jpg K120520 - EXACTRAC ROBOTICS NOVALIS ROBOTICS K120520 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab AG. Cleared Jun 2012. https://www.510kdatabase.net/k121092/ 2012-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k121092-flowease-subcutaneous-infusion-set-fda-510k.jpg K121092 - FLOWEASE [SUBCUTANEOUS] INFUSION SET K121092 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jun 2012. https://www.510kdatabase.net/k103467/ 2012-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k103467-cmos-video-rhino-laryngoscope-system-fda-510k.jpg K103467 - CMOS VIDEO RHINO-LARYNGOSCOPE SYSTEM MODEL 11101CM K103467 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jun 2012. https://www.510kdatabase.net/k113704/ 2012-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k113704-architect-havab-g-fda-510k.jpg K113704 - ARCHITECT HAVAB-G K113704 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Jun 2012. https://www.510kdatabase.net/k120780/ 2012-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k120780-edward-proplege-peripheral-retrograde-fda-510k.jpg K120780 - EDWARD PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE K120780 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Jun 2012. https://www.510kdatabase.net/k121049/ 2012-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k121049-unify-dynamic-anterior-cervical-plate-fda-510k.jpg K121049 - UNIFY DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM K121049 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Jun 2012. https://www.510kdatabase.net/k121295/ 2012-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k121295-artistetm-solution-with-sys-vcio-fda-510k.jpg K121295 - ARTISTETM SOLUTION WITH SYS VCIO K121295 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 2012. https://www.510kdatabase.net/k120632/ 2012-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k120632-amsco-v-pro-1-lowplusmax-temperature-fda-510k.jpg K120632 - AMSCO V-PRO 1 LOW/PLUS/MAX TEMPERATURE STERILIZATION SYSTEM K120632 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Jun 2012. https://www.510kdatabase.net/k121290/ 2012-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k121290-aquamantrys3-bsc-91s-fda-510k.jpg K121290 - AQUAMANTRYS3 BSC 9.1S K121290 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medtronic, Inc.. Cleared Jun 2012. https://www.510kdatabase.net/k121018/ 2012-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k121018-bioraptor-29-bioraptor-23-pk-fda-510k.jpg K121018 - BIORAPTOR 2.9, BIORAPTOR 2.3 PK, OSTEORAPTOR, & BIORAPTOR KNOTLESS SUTURE AN K121018 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jun 2012. https://www.510kdatabase.net/k121459/ 2012-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k121459-syngomr-neurology-fda-510k.jpg K121459 - SYNGO.MR NEUROLOGY K121459 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 2012. https://www.510kdatabase.net/k121699/ 2012-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k121699-acuson-x300-diagnostic-ultrasound-fda-510k.jpg K121699 - ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM SONOVISTA X300 DIAGNOSTIC ULTRASOUND SYSTEM K121699 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 2012. https://www.510kdatabase.net/k120854/ 2012-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k120854-synthes-va-lcp-ankle-trauma-system-fda-510k.jpg K120854 - SYNTHES VA LCP ANKLE TRAUMA SYSTEM K120854 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jun 2012. https://www.510kdatabase.net/k113395/ 2012-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k113395-revere-45-stabilization-system-fda-510k.jpg K113395 - REVERE 4.5 STABILIZATION SYSTEM K113395 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Jun 2012. https://www.510kdatabase.net/k121451/ 2012-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k121451-cardioblate-maps-surgical-mapping-fda-510k.jpg K121451 - CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING , AND SENSING DEVICE K121451 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Jun 2012. https://www.510kdatabase.net/k121051/ 2012-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k121051-concierge-guiding-catheter-fda-510k.jpg K121051 - CONCIERGE GUIDING CATHETER K121051 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jun 2012. https://www.510kdatabase.net/k120769/ 2012-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k120769-modulth-slk-fda-510k.jpg K120769 - MODULTH SLK K120769 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jun 2012. https://www.510kdatabase.net/k113205/ 2012-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k113205-artisyn-y-shaped-mesh-fda-510k.jpg K113205 - ARTISYN Y-SHAPED MESH K113205 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ethicon, Inc.. Cleared Jun 2012. https://www.510kdatabase.net/k113411/ 2012-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k113411-edward-vent-catheters-edward-vent-fda-510k.jpg K113411 - EDWARD VENT CATHETERS EDWARD VENT CATHETERS WITH DURAFLO COATING DISPERSION AORTIC PERFUSION CANNULA K113411 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Jun 2012. https://www.510kdatabase.net/k121074/ 2012-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k121074-scenium-20-fda-510k.jpg K121074 - SCENIUM 2.0 K121074 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 2012. https://www.510kdatabase.net/k120808/ 2012-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k120808-export-xt-catheter-export-ap-catheter-fda-510k.jpg K120808 - EXPORT XT CATHETER, EXPORT AP CATHETER K120808 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Jun 2012. https://www.510kdatabase.net/k120871/ 2012-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k120871-smith-nephew-inc-external-fixation-fda-510k.jpg K120871 - SMITH & NEPHEW, INC. EXTERNAL FIXATION SYSTEM INSTRUMENTATION K120871 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jun 2012. https://www.510kdatabase.net/k120731/ 2012-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k120731-titanium-fletcher-style-applicator-set-fda-510k.jpg K120731 - TITANIUM FLETCHER-STYLE APPLICATOR SET-DEFINED GEOMETRY K120731 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Jun 2012. https://www.510kdatabase.net/k120987/ 2012-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k120987-dlp-single-stage-venous-cannula-fda-510k.jpg K120987 - DLP SINGLE STAGE VENOUS CANNULA INFLATABLE CUFF K120987 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Jun 2012. https://www.510kdatabase.net/k120370/ 2012-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k120370-vivacit-e-vitamin-e-highly-crosslinked-fda-510k.jpg K120370 - VIVACIT-E VITAMIN E HIGHLY CROSSLINKED POLYETHYLENE LINERS K120370 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jun 2012. https://www.510kdatabase.net/k120435/ 2012-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k120435-browne-aldahol-glutaraldehyde-indicator-fda-510k.jpg K120435 - BROWNE ALDAHOL GLUTARALDEHYDE INDICATOR K120435 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Jun 2012. https://www.510kdatabase.net/k121073/ 2012-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k121073-powerglide-midline-catheter-fda-510k.jpg K121073 - POWERGLIDE MIDLINE CATHETER K121073 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jun 2012. https://www.510kdatabase.net/k121307/ 2012-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k121307-optetrak-logic-cr-tibial-insert-size-0-fda-510k.jpg K121307 - OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 0 OPTETRAK LOGIC CR TIBIAL INSERT, SIZE 6 OPTETRAK LOGIC CR FEMORAL COMPONENT, SIZ K121307 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared May 2012. https://www.510kdatabase.net/k120271/ 2012-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k120271-artisan-space-maintenance-system-fda-510k.jpg K120271 - ARTISAN SPACE MAINTENANCE SYSTEM K120271 is a FDA 510(k) cleared dental medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared May 2012. https://www.510kdatabase.net/k110472/ 2012-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k110472-si-fix-sacroiliac-joint-fusion-system-fda-510k.jpg K110472 - SI-FIX SACROILIAC JOINT FUSION SYSTEM K110472 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared May 2012. https://www.510kdatabase.net/k120612/ 2012-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k120612-medtronic-clear-intravacular-fda-510k.jpg K120612 - MEDTRONIC CLEAR INTRAVACULAR ARTERIOTOMY SHUNT K120612 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared May 2012. https://www.510kdatabase.net/k120150/ 2012-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k120150-dual-spike-transfer-device-fda-510k.jpg K120150 - DUAL SPIKE TRANSFER DEVICE K120150 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared May 2012. https://www.510kdatabase.net/k120559/ 2012-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k120559-aesculap-meithke-prosa-adjustable-fda-510k.jpg K120559 - AESCULAP-MEITHKE PROSA ADJUSTABLE SHUNT SYSTEM K120559 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared May 2012. https://www.510kdatabase.net/k113287/ 2012-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k113287-somatom-perspective-fda-510k.jpg K113287 - SOMATOM PERSPECTIVE K113287 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 2012. https://www.510kdatabase.net/k121265/ 2012-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k121265-amphirion-plus-pta-catheter-fda-510k.jpg K121265 - AMPHIRION PLUS PTA CATHETER K121265 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared May 2012. https://www.510kdatabase.net/k120495/ 2012-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k120495-impulse-and-expo-angiographic-catheter-fda-510k.jpg K120495 - IMPULSE AND EXPO ANGIOGRAPHIC CATHETER K120495 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared May 2012. https://www.510kdatabase.net/k113565/ 2012-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k113565-multi-med-central-venous-catheters-fda-510k.jpg K113565 - MULTI-MED CENTRAL VENOUS CATHETERS (CVCS), WITH AND WITHOUT HEPARIN VANTEX CENTRAL VENOUS CATHETERS (CVCS), WITH HEPARIN K113565 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared May 2012. https://www.510kdatabase.net/k120698/ 2012-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k120698-genesis-ii-ps-non-modular-femoral-fda-510k.jpg K120698 - GENESIS II PS NON-MODULAR FEMORAL COMPONENT K120698 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared May 2012. https://www.510kdatabase.net/k121314/ 2012-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k121314-architect-b12-fda-510k.jpg K121314 - ARCHITECT B12 K121314 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared May 2012. https://www.510kdatabase.net/k112127/ 2012-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k112127-pico-single-use-negative-pressure-fda-510k.jpg K112127 - PICO SINGLE USE NEGATIVE PRESSURE WOUND THERAPY SYSTEM K112127 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared May 2012. https://www.510kdatabase.net/k121124/ 2012-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k121124-arthrex-mixing-and-delivery-system-fda-510k.jpg K121124 - ARTHREX MIXING AND DELIVERY SYSTEM K121124 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Arthrex, Inc.. Cleared May 2012. https://www.510kdatabase.net/k121186/ 2012-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k121186-radial-jaw-4-pulmonary-biopsy-forceps-fda-510k.jpg K121186 - RADIAL JAW 4 PULMONARY BIOPSY FORCEPS K121186 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Boston Scientific Corp. Cleared May 2012. https://www.510kdatabase.net/k120681/ 2012-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k120681-advia-chemistry-gluh3-reagents-fda-510k.jpg K120681 - ADVIA CHEMISTRY GLUH_3 REAGENTS K120681 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared May 2012. https://www.510kdatabase.net/k111188/ 2012-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k111188-cobas-b-123-poc-system-cobas-b-123-fda-510k.jpg K111188 - COBAS B 123 POC SYSTEM, COBAS B 123 AUTOQC PACK TRI-LEVEL, COBAS B 123 AUTOCVC PACK, ROCHE COMBITROL PLUS B K111188 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared May 2012. https://www.510kdatabase.net/k120537/ 2012-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k120537-aquamantys3-95-xl-bipolar-sealer-fda-510k.jpg K120537 - AQUAMANTYS3 9.5 XL BIPOLAR SEALER K120537 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medtronic, Inc.. Cleared May 2012. https://www.510kdatabase.net/k121279/ 2012-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k121279-elecsys-lh-calcheck-5-fda-510k.jpg K121279 - ELECSYS LH CALCHECK 5 K121279 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared May 2012. https://www.510kdatabase.net/k121084/ 2012-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k121084-loci-cardiac-troponin-i-control-low-fda-510k.jpg K121084 - LOCI CARDIAC TROPONIN-I CONTROL (LOW), LCTNI CON L K121084 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared May 2012. https://www.510kdatabase.net/k112403/ 2012-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k112403-amsco-chimeron-medium-steam-sterlilzer-fda-510k.jpg K112403 - AMSCO CHIMERON MEDIUM STEAM STERLILZER K112403 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared May 2012. https://www.510kdatabase.net/k113521/ 2012-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k113521-calcium-gen-2-fda-510k.jpg K113521 - CALCIUM GEN. 2 K113521 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared May 2012. https://www.510kdatabase.net/k120072/ 2012-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k120072-venous-drainage-cannula-with-duraflo-fda-510k.jpg K120072 - VENOUS DRAINAGE CANNULA WITH DURAFLO COATING K120072 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared May 2012. https://www.510kdatabase.net/k120717/ 2012-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k120717-synthes-variable-angle-lcp-elbow-fda-510k.jpg K120717 - SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM (MEDICAL AND POSTEROLATERAL DISTAL HUMERUS PLATES) K120717 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared May 2012. https://www.510kdatabase.net/k113732/ 2012-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k113732-iplan-iplan-cranial-iplan-stereotaxy-fda-510k.jpg K113732 - IPLAN (IPLAN CRANIAL, IPLAN STEREOTAXY, IPLAN ENT, IPLAN CMF, IPLAN VIEW, IPLAN SPINE) K113732 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab AG. Cleared May 2012. https://www.510kdatabase.net/k112797/ 2012-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k112797-powerflex-pro-percutaneous-fda-510k.jpg K112797 - POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER K112797 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared May 2012. https://www.510kdatabase.net/k112995/ 2012-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k112995-gem-premier-4000-fda-510k.jpg K112995 - GEM PREMIER 4000 K112995 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared May 2012. https://www.510kdatabase.net/k120359/ 2012-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k120359-ortholoc-3di-hallux-system-fda-510k.jpg K120359 - ORTHOLOC 3DI HALLUX SYSTEM K120359 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared May 2012. https://www.510kdatabase.net/k120704/ 2012-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k120704-3m-littmann-telesteth-online-fda-510k.jpg K120704 - 3M LITTMANN TELESTETH ONLINE AUSCULATION SYSTEM K120704 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: 3M Company. Cleared May 2012. https://www.510kdatabase.net/k120983/ 2012-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k120983-ultraflex-esophageal-ng-stent-system-fda-510k.jpg K120983 - ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM K120983 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared May 2012. https://www.510kdatabase.net/k120215/ 2012-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k120215-single-site-medium-large-clip-applier-fda-510k.jpg K120215 - SINGLE-SITE MEDIUM-LARGE CLIP APPLIER, SINGLE-SITE CADIERE GRASPER, SINGLE-SITE FUNDUS GRASPER, SINGLE-SITE CROCODILE K120215 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Apr 2012. https://www.510kdatabase.net/k113848/ 2012-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k113848-r3-xlpe-liners-fda-510k.jpg K113848 - R3 XLPE LINERS K113848 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Apr 2012. https://www.510kdatabase.net/k120341/ 2012-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k120341-plastic-needle-with-mandrin-20-fda-510k.jpg K120341 - PLASTIC NEEDLE WITH MANDRIN 2.0 DIAMETER LENGTH 113MM K120341 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Apr 2012. https://www.510kdatabase.net/k120741/ 2012-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k120741-voluson-s6-voluson-s8-fda-510k.jpg K120741 - VOLUSON S6, VOLUSON S8 K120741 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Apr 2012. https://www.510kdatabase.net/k120645/ 2012-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k120645-pro-toetm-vo-hamertoe-implant-system-fda-510k.jpg K120645 - PRO-TOE(TM) VO HAMERTOE IMPLANT SYSTEM-LINE SDDITION K120645 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Apr 2012. https://www.510kdatabase.net/k113719/ 2012-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k113719-safety-screw-connector-fda-510k.jpg K113719 - SAFETY SCREW CONNECTOR K113719 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Abbott Laboratories. Cleared Apr 2012. https://www.510kdatabase.net/k120428/ 2012-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k120428-gore-dryseal-sheath-fda-510k.jpg K120428 - GORE DRYSEAL SHEATH K120428 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Apr 2012. https://www.510kdatabase.net/k113789/ 2012-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k113789-modular-proximally-fluted-hip-stem-fda-510k.jpg K113789 - MODULAR PROXIMALLY FLUTED HIP STEM K113789 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Apr 2012. https://www.510kdatabase.net/k120699/ 2012-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k120699-dc-t6-diagnostic-ultrasound-system-fda-510k.jpg K120699 - DC-T6 DIAGNOSTIC ULTRASOUND SYSTEM K120699 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Apr 2012. https://www.510kdatabase.net/k121010/ 2012-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k121010-m7m7t-diagnostic-ultrasound-system-fda-510k.jpg K121010 - M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM K121010 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Apr 2012. https://www.510kdatabase.net/k121019/ 2012-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k121019-optima-nmct-640-fda-510k.jpg K121019 - OPTIMA NM/CT 640 K121019 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Apr 2012. https://www.510kdatabase.net/k120117/ 2012-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k120117-codman-quad-lock-sterilization-fda-510k.jpg K120117 - CODMAN QUAD-LOCK STERILIZATION CONTAINER SYSTEM K120117 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Apr 2012. https://www.510kdatabase.net/k120092/ 2012-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k120092-plymouth-thoracolumbar-plate-system-fda-510k.jpg K120092 - PLYMOUTH THORACOLUMBAR PLATE SYSTEM K120092 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Apr 2012. https://www.510kdatabase.net/k120315/ 2012-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k120315-syngomr-spectro-engine-syngomr-spectro-fda-510k.jpg K120315 - SYNGO.MR SPECTRO ENGINE, SYNGO.MR SPECTRO SVS, SYNGO.MR SPECTRO CSI, SYNGO.MR SPECTRO EXTENSION K120315 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 2012. https://www.510kdatabase.net/k113583/ 2012-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k113583-curad-antibacterial-bandage-fda-510k.jpg K113583 - CURAD ANTIBACTERIAL BANDAGE K113583 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medline Industries, Inc.. Cleared Apr 2012. https://www.510kdatabase.net/k112989/ 2012-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k112989-aquilion-cxl-fda-510k.jpg K112989 - AQUILION CXL K112989 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Apr 2012. https://www.510kdatabase.net/k120368/ 2012-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k120368-capstone-control-spinal-system-fda-510k.jpg K120368 - CAPSTONE CONTROL SPINAL SYSTEM K120368 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Apr 2012. https://www.510kdatabase.net/k111997/ 2012-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k111997-image1-gi-ccu-model-22203020-114-fda-510k.jpg K111997 - IMAGE1 GI CCU MODEL 22203020-114 K111997 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Apr 2012. https://www.510kdatabase.net/k112899/ 2012-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k112899-arthrex-bio-suture-fda-510k.jpg K112899 - ARTHREX BIO-SUTURE K112899 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Arthrex, Inc.. Cleared Apr 2012. https://www.510kdatabase.net/k120667/ 2012-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k120667-vlp-27mm-extra-large-percutaneous-fda-510k.jpg K120667 - VLP 2.7MM EXTRA LARGE PERCUTANEOUS CALCANEUS PLATE, PERI-LOC 3.5MM ANTERIOR ANKLE FUSION PLATES, PERI-LOC 3.5MM HINDFOOT K120667 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Apr 2012. https://www.510kdatabase.net/k120686/ 2012-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k120686-orbit-galaxy-g2-microcoil-delivery-fda-510k.jpg K120686 - ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM K120686 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Apr 2012. https://www.510kdatabase.net/k120069/ 2012-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k120069-medline-stopcock-and-manifold-fda-510k.jpg K120069 - MEDLINE STOPCOCK AND MANIFOLD K120069 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medline Industries, Inc.. Cleared Apr 2012. https://www.510kdatabase.net/k120694/ 2012-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k120694-encore-26-advantage-kit-fda-510k.jpg K120694 - ENCORE 26 ADVANTAGE KIT K120694 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Apr 2012. https://www.510kdatabase.net/k120802/ 2012-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k120802-ortholoctm-3di-locking-screws-fda-510k.jpg K120802 - ORTHOLOC(TM) 3DI LOCKING SCREWS ORTHOLOC(TM) BONE SCREWS K120802 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Apr 2012. https://www.510kdatabase.net/k120145/ 2012-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k120145-simple-t-nasal-mask-fda-510k.jpg K120145 - SIMPLE T NASAL MASK K120145 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Mar 2012. https://www.510kdatabase.net/k120221/ 2012-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k120221-ge-echopac-fda-510k.jpg K120221 - GE ECHOPAC K120221 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Mar 2012. https://www.510kdatabase.net/den110002/ 2012-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/den110002-system-1e-process-biological-fda-510k.jpg DEN110002 - SYSTEM 1E PROCESS BIOLOGICAL MONITORING KIT DEN110002 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Mar 2012. https://www.510kdatabase.net/k120893/ 2012-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k120893-imager-ii-angiographic-catheters-fda-510k.jpg K120893 - IMAGER II ANGIOGRAPHIC CATHETERS K120893 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Mar 2012. https://www.510kdatabase.net/k113369/ 2012-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k113369-zimmer-persona-knee-system-fda-510k.jpg K113369 - ZIMMER PERSONA KNEE SYSTEM K113369 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Mar 2012. https://www.510kdatabase.net/k120101/ 2012-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k120101-independence-spacer-fda-510k.jpg K120101 - INDEPENDENCE SPACER K120101 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Mar 2012. https://www.510kdatabase.net/k112377/ 2012-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k112377-bs-400-chemistry-analyzer-clc-720-fda-510k.jpg K112377 - BS-400 CHEMISTRY ANALYZER, CLC 720 CHEMISTRY ANALYZER K112377 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Mar 2012. https://www.510kdatabase.net/k113117/ 2012-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k113117-nihon-kohden-eeg-1200a-with-je-120a-fda-510k.jpg K113117 - NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX K113117 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Mar 2012. https://www.510kdatabase.net/k113220/ 2012-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k113220-emerge-ptca-dilatation-catheter-fda-510k.jpg K113220 - EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) K113220 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Mar 2012. https://www.510kdatabase.net/k120070/ 2012-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k120070-synthes-variable-angle-lcp-elbow-system-fda-510k.jpg K120070 - SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM K120070 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Mar 2012. https://www.510kdatabase.net/k120363/ 2012-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k120363-syngo-rt-interface-fda-510k.jpg K120363 - SYNGO RT INTERFACE K120363 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2012. https://www.510kdatabase.net/k120540/ 2012-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k120540-biobolt-fda-510k.jpg K120540 - BIOBOLT K120540 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Mar 2012. https://www.510kdatabase.net/k113808/ 2012-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k113808-the-sherlock-3cg-tip-confirmation-fda-510k.jpg K113808 - THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS) K113808 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 2012. https://www.510kdatabase.net/k113320/ 2012-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k113320-novation-element-femoral-stem-1214-fda-510k.jpg K113320 - NOVATION ELEMENT FEMORAL STEM, 12/14 COLLARLESS STANDARD/HIGH OFFSET HA COATED PRESS-FIT, SZ 8-12 K113320 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Mar 2012. https://www.510kdatabase.net/k113766/ 2012-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k113766-clickfit-transfer-guide-tubes-needle-fda-510k.jpg K113766 - CLICKFIT TRANSFER GUIDE TUBES NEEDLE CLICKFIT TRANSFER GUIDE TUBES CATHETER TRANSFER GUIDE TUBE SET VARISOURCE LUER TRAN K113766 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Mar 2012. https://www.510kdatabase.net/k120485/ 2012-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k120485-nihon-kohden-qp-160-ak-trend-program-fda-510k.jpg K120485 - NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT P K120485 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Mar 2012. https://www.510kdatabase.net/k113090/ 2012-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k113090-leveen-superslim-needle-electrode-fda-510k.jpg K113090 - LEVEEN SUPERSLIM NEEDLE ELECTRODE K113090 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Boston Scientific Corporation. Cleared Mar 2012. https://www.510kdatabase.net/k111663/ 2012-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k111663-trauma-internal-fixation-systems-fda-510k.jpg K111663 - TRAUMA INTERNAL FIXATION SYSTEMS K111663 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Mar 2012. https://www.510kdatabase.net/k120044/ 2012-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k120044-arthrex-universii-xl-glenoid-pegged-fda-510k.jpg K120044 - ARTHREX UNIVERSII XL GLENOID-PEGGED, ARTHREX UNIVERS II XL GLENOID-KEELED K120044 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Mar 2012. https://www.510kdatabase.net/k113274/ 2012-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k113274-footprint-ultra-pk-suture-anchor-fda-510k.jpg K113274 - FOOTPRINT ULTRA PK SUTURE ANCHOR K113274 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Mar 2012. https://www.510kdatabase.net/k112769/ 2012-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k112769-curad-compression-hosiery-fda-510k.jpg K112769 - CURAD COMPRESSION HOSIERY K112769 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Mar 2012. https://www.510kdatabase.net/k111893/ 2012-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k111893-vitekr-2-streptococcus-tetracycline-fda-510k.jpg K111893 - VITEK(R) 2 STREPTOCOCCUS TETRACYCLINE K111893 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Feb 2012. https://www.510kdatabase.net/k120024/ 2012-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k120024-mectalif-transforaminal-fda-510k.jpg K120024 - MECTALIF TRANSFORAMINAL K120024 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Feb 2012. https://www.510kdatabase.net/k113482/ 2012-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k113482-journey-ii-deep-dished-articular-inserts-fda-510k.jpg K113482 - JOURNEY II DEEP DISHED ARTICULAR INSERTS K113482 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Feb 2012. https://www.510kdatabase.net/k120229/ 2012-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k120229-envoy-distal-access-guiding-catheter-fda-510k.jpg K120229 - ENVOY DISTAL ACCESS GUIDING CATHETER K120229 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Feb 2012. https://www.510kdatabase.net/k120019/ 2012-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k120019-collagen-ribbon-fda-510k.jpg K120019 - COLLAGEN RIBBON K120019 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Feb 2012. https://www.510kdatabase.net/k113520/ 2012-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k113520-system-1e-liquid-chemical-sterilant-fda-510k.jpg K113520 - SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM K113520 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Feb 2012. https://www.510kdatabase.net/k111976/ 2012-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k111976-vitek-2-streptococcus-erythromycin-fda-510k.jpg K111976 - VITEK 2 STREPTOCOCCUS ERYTHROMYCIN K111976 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Feb 2012. https://www.510kdatabase.net/k120155/ 2012-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k120155-arthrex-knotless-suturetak-anchor-fda-510k.jpg K120155 - ARTHREX KNOTLESS SUTURETAK ANCHOR K120155 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Feb 2012. https://www.510kdatabase.net/k111860/ 2012-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k111860-bd-max-gbs-assay-bd-max-instrument-fda-510k.jpg K111860 - BD MAX GBS ASSAY, BD MAX INSTRUMENT K111860 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Feb 2012. https://www.510kdatabase.net/k111874/ 2012-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k111874-freestyle-insulinx-blood-glucose-fda-510k.jpg K111874 - FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS K111874 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Feb 2012. https://www.510kdatabase.net/k120121/ 2012-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k120121-comprehensive-reverse-shoulder-mini-fda-510k.jpg K120121 - COMPREHENSIVE REVERSE SHOULDER-MINI BASEPLATE K120121 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Feb 2012. https://www.510kdatabase.net/k113409/ 2012-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k113409-s2-femoral-ar-nail-s2-femoral-fda-510k.jpg K113409 - S2 FEMORAL A/R NAIL S2 FEMORAL COMRESSION NAIL S2 TIBIAL NAIL S2 TIBIAL COMPRESSION NAIL K113409 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Feb 2012. https://www.510kdatabase.net/k112994/ 2012-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k112994-cre-ditatation-ballon-fda-510k.jpg K112994 - CRE DITATATION BALLON K112994 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Feb 2012. https://www.510kdatabase.net/k113305/ 2012-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k113305-vitek-2-streptococcus-fda-510k.jpg K113305 - VITEK 2 STREPTOCOCCUS TRIMETHOPRIM/SULFAMETHOXAZOLE K113305 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Feb 2012. https://www.510kdatabase.net/k113529/ 2012-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k113529-cd-horizon-voyager-spinal-system-fda-510k.jpg K113529 - CD HORIZON VOYAGER SPINAL SYSTEM K113529 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Feb 2012. https://www.510kdatabase.net/k120083/ 2012-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k120083-set-screw-for-ti-trochanteric-fixation-fda-510k.jpg K120083 - SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN) K120083 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Feb 2012. https://www.510kdatabase.net/k111959/ 2012-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k111959-aesculap-histoacryl-and-histoacryl-fda-510k.jpg K111959 - AESCULAP HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE K111959 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Feb 2012. https://www.510kdatabase.net/k113322/ 2012-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k113322-conserve-thin-shell-fda-510k.jpg K113322 - CONSERVE THIN SHELL K113322 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Feb 2012. https://www.510kdatabase.net/k113053/ 2012-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k113053-bipap-a-30-ventilatory-support-system-fda-510k.jpg K113053 - BIPAP A 30 VENTILATORY SUPPORT SYSTEM K113053 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Feb 2012. https://www.510kdatabase.net/k112526/ 2012-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k112526-twinfix-ultra-ti-twinfix-ultra-pk-fda-510k.jpg K112526 - TWINFIX ULTRA TI, TWINFIX ULTRA PK, TWINFIX ULTRA HA SUTURE ANCHORS K112526 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jan 2012. https://www.510kdatabase.net/k113014/ 2012-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k113014-claw-ii-polyaxial-compression-system-fda-510k.jpg K113014 - CLAW II POLYAXIAL COMPRESSION SYSTEM AND ORTHOLOC 3DSI LOCKING SCREWS K113014 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jan 2012. https://www.510kdatabase.net/k110066/ 2012-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k110066-aquilion-prime-fda-510k.jpg K110066 - AQUILION PRIME K110066 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Jan 2012. https://www.510kdatabase.net/k113447/ 2012-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k113447-rise-spacer-fda-510k.jpg K113447 - RISE SPACER K113447 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Jan 2012. https://www.510kdatabase.net/k113845/ 2012-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k113845-tubing-conmnectors-and-accessories-wit-fda-510k.jpg K113845 - TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACE K113845 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Jan 2012. https://www.510kdatabase.net/k113059/ 2012-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k113059-contiplex-fx-fda-510k.jpg K113059 - CONTIPLEX FX K113059 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Jan 2012. https://www.510kdatabase.net/k110874/ 2012-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k110874-advia-chemistry-reagents-and-advia-fda-510k.jpg K110874 - ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATOR K110874 is a FDA 510(k) cleared immunology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Jan 2012. https://www.510kdatabase.net/k112343/ 2012-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k112343-treponema-pallidum-treponemal-test-fda-510k.jpg K112343 - TREPONEMA PALLIDUM TREPONEMAL TEST REAGENTS K112343 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Jan 2012. https://www.510kdatabase.net/k113294/ 2012-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k113294-smith-nephew-healicoil-pk-suture-anchor-fda-510k.jpg K113294 - SMITH & NEPHEW HEALICOIL PK SUTURE ANCHOR K113294 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jan 2012. https://www.510kdatabase.net/k113101/ 2012-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k113101-exxcel-soft-eptee-vascular-graft-fda-510k.jpg K113101 - EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL K113101 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Jan 2012. https://www.510kdatabase.net/k113252/ 2012-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k113252-peek-prevail-cervical-interbody-device-fda-510k.jpg K113252 - PEEK PREVAIL CERVICAL INTERBODY DEVICE K113252 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Jan 2012. https://www.510kdatabase.net/k111788/ 2012-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k111788-endoeye-hd-ii-fda-510k.jpg K111788 - ENDOEYE HD II K111788 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Olympus America, Inc.. Cleared Jan 2012. https://www.510kdatabase.net/k113667/ 2012-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k113667-cardioplegia-delivery-sets-fda-510k.jpg K113667 - CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH DURAFLO COATING K113667 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Jan 2012. https://www.510kdatabase.net/k112256/ 2012-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k112256-steris-steam-pi-fda-510k.jpg K112256 - STERIS STEAM PI K112256 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Jan 2012. https://www.510kdatabase.net/k113651/ 2012-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k113651-interlock-35-fibered-idc-occlusion-fda-510k.jpg K113651 - INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM K113651 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Jan 2012. https://www.510kdatabase.net/k113758/ 2012-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k113758-voluson-e6e8e8experte10-fda-510k.jpg K113758 - VOLUSON E6/E8/E8EXPERT/E10 K113758 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ge Healthcare. Cleared Jan 2012. https://www.510kdatabase.net/k111165/ 2012-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k111165-karl-storz-scb-covidien-forcetriad-fda-510k.jpg K111165 - KARL STORZ SCB / COVIDIEN FORCETRIAD INTERFACE MODULE K111165 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jan 2012. https://www.510kdatabase.net/k112523/ 2012-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k112523-immulite-2000-3gallergy-specific-ige-fda-510k.jpg K112523 - IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT K112523 is a FDA 510(k) cleared immunology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Jan 2012. https://www.510kdatabase.net/k113137/ 2012-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k113137-glucose-test-system-fda-510k.jpg K113137 - GLUCOSE TEST SYSTEM K113137 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Jan 2012. https://www.510kdatabase.net/k113012/ 2012-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k113012-promos-modular-shoulder-system-fda-510k.jpg K113012 - PROMOS MODULAR SHOULDER SYSTEM K113012 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jan 2012. https://www.510kdatabase.net/k113038/ 2012-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k113038-smith-nephew-inc-unicompartmental-and-fda-510k.jpg K113038 - SMITH & NEPHEW INC. UNICOMPARTMENTAL AND BIOCOMPARTMENTAL KNEE SYSTEM INSTRUMENTS K113038 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jan 2012. https://www.510kdatabase.net/k113211/ 2012-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k113211-hemosil-la-positive-control-hemosil-la-fda-510k.jpg K113211 - HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL K113211 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jan 2012. https://www.510kdatabase.net/k113609/ 2012-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k113609-novation-integrip-acetabular-augments-fda-510k.jpg K113609 - NOVATION INTEGRIP ACETABULAR AUGMENTS, GROUPS 4 AND 5 K113609 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Jan 2012. https://www.510kdatabase.net/k113373/ 2011-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k113373-dimension-vista-loci-9-calibrator-loci-fda-510k.jpg K113373 - DIMENSION VISTA LOCI 9 CALIBRATOR- LOCI 9 CAL K113373 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Dec 2011. https://www.510kdatabase.net/k112543/ 2011-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k112543-wallflex-biliary-transhepatic-fda-510k.jpg K112543 - WALLFLEX BILIARY TRANSHEPATIC UNCOVERED STENT SYSTEM, WALLFLEX BILIARY TRANSHEPATIC COVERED STENT SYSTEM K112543 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Dec 2011. https://www.510kdatabase.net/k113690/ 2011-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k113690-ge-logiq-i-logiq-e-and-vivid-e-fda-510k.jpg K113690 - GE LOGIQ I, LOGIQ E AND VIVID E K113690 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Dec 2011. https://www.510kdatabase.net/k110639/ 2011-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k110639-endowrist-one-vessel-sealer-fda-510k.jpg K110639 - ENDOWRIST ONE VESSEL SEALER K110639 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Dec 2011. https://www.510kdatabase.net/k112080/ 2011-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k112080-preserve-hip-stem-fda-510k.jpg K112080 - PRESERVE HIP STEM K112080 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Dec 2011. https://www.510kdatabase.net/k112933/ 2011-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k112933-access-thyroglobulin-anitbody-fda-510k.jpg K112933 - ACCESS THYROGLOBULIN ANITBODY K112933 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Dec 2011. https://www.510kdatabase.net/k110313/ 2011-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k110313-tina-quant-hba1c-gen2-fda-510k.jpg K110313 - TINA-QUANT HBA1C GEN.2 K110313 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Dec 2011. https://www.510kdatabase.net/k110726/ 2011-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k110726-roche-acetaminophen-assay-fda-510k.jpg K110726 - ROCHE ACETAMINOPHEN ASSAY K110726 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Dec 2011. https://www.510kdatabase.net/k112412/ 2011-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k112412-au5800r-chemistry-analyzer-fda-510k.jpg K112412 - AU5800(R) CHEMISTRY ANALYZER K112412 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Dec 2011. https://www.510kdatabase.net/k110381/ 2011-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k110381-cell-dyn-emerald-22-system-fda-510k.jpg K110381 - CELL-DYN EMERALD 22 SYSTEM K110381 is a FDA 510(k) cleared hematology medical device. Manufacturer: Abbott Laboratories. Cleared Dec 2011. https://www.510kdatabase.net/k112515/ 2011-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k112515-pencan-spinal-needle-fda-510k.jpg K112515 - PENCAN SPINAL NEEDLE K112515 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Dec 2011. https://www.510kdatabase.net/k112437/ 2011-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k112437-arthrex-fracture-system-fda-510k.jpg K112437 - ARTHREX FRACTURE SYSTEM K112437 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Dec 2011. https://www.510kdatabase.net/k112941/ 2011-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k112941-legion-narrow-oxinium-cruciate-fda-510k.jpg K112941 - LEGION NARROW OXINIUM CRUCIATE RETAINING AND POSTERIOR STABILIZED FENORAL COMPONENTS K112941 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Dec 2011. https://www.510kdatabase.net/k113004/ 2011-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k113004-pdstm-barbed-sutures-fda-510k.jpg K113004 - PDS(TM) BARBED SUTURES K113004 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Dec 2011. https://www.510kdatabase.net/k113528/ 2011-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k113528-clydesdaler-spinal-system-fda-510k.jpg K113528 - CLYDESDALE(R) SPINAL SYSTEM K113528 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Dec 2011. https://www.510kdatabase.net/k112885/ 2011-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k112885-zimmer-plates-and-screws-system-screws-fda-510k.jpg K112885 - ZIMMER PLATES AND SCREWS SYSTEM SCREWS ONLY K112885 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Dec 2011. https://www.510kdatabase.net/k112990/ 2011-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k112990-acl-tightropeacl-tightrope-duuble-bundle-fda-510k.jpg K112990 - ACL TIGHTROPE,ACL TIGHTROPE DUUBLE BUNDLE K112990 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Dec 2011. https://www.510kdatabase.net/k113448/ 2011-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k113448-biograph-mct-family-fda-510k.jpg K113448 - BIOGRAPH MCT FAMILY K113448 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Dec 2011. https://www.510kdatabase.net/k110360/ 2011-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k110360-prophecy-inbone-pre-operative-fda-510k.jpg K110360 - PROPHECY INBONE PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES K110360 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Dec 2011. https://www.510kdatabase.net/k112055/ 2011-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k112055-amsco-chimeron-medium-steam-sterilizer-fda-510k.jpg K112055 - AMSCO CHIMERON MEDIUM STEAM STERILIZER K112055 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Dec 2011. https://www.510kdatabase.net/k113068/ 2011-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k113068-remstar-auto-a-flex-ht-fda-510k.jpg K113068 - REMSTAR AUTO A-FLEX HT K113068 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Dec 2011. https://www.510kdatabase.net/k113647/ 2011-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k113647-dc-8dc-8-prodc-8-cvdc-8-expdc-8s-fda-510k.jpg K113647 - DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S DIAGNOSTIC ULTRASOUND SYSTEM K113647 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Dec 2011. https://www.510kdatabase.net/k111170/ 2011-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k111170-pico-fda-510k.jpg K111170 - PICO K111170 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Dec 2011. https://www.510kdatabase.net/k111746/ 2011-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k111746-comprehensive-segmental-revision-fda-510k.jpg K111746 - COMPREHENSIVE SEGMENTAL REVISION SYSTEM (SRS) K111746 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Dec 2011. https://www.510kdatabase.net/k112040/ 2011-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k112040-arthrex-biocomposite-transfix-fda-510k.jpg K112040 - ARTHREX BIOCOMPOSITE TRANSFIX K112040 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Dec 2011. https://www.510kdatabase.net/k112218/ 2011-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k112218-ace-fischerr-tempfixr-hoffman-fda-510k.jpg K112218 - ACE-FISCHER(R), TEMPFIX(R), HOFFMAN CLASSIC(TM) EXTERNAL FIXATORS K112218 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Dec 2011. https://www.510kdatabase.net/k112480/ 2011-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k112480-view-1-imaging-fda-510k.jpg K112480 - VIEW 1 IMAGING K112480 is a FDA 510(k) cleared radiology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Dec 2011. https://www.510kdatabase.net/k113034/ 2011-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k113034-ge-innova-solid-state-xray-imager-fda-510k.jpg K113034 - GE INNOVA SOLID STATE XRAY IMAGER FLUROSOPIC X RAY SYSTEM K113034 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Dec 2011. https://www.510kdatabase.net/k102425/ 2011-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k102425-zeus-elisa-cardiolipin-iggigmiga-test-fda-510k.jpg K102425 - ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM K102425 is a FDA 510(k) cleared immunology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Dec 2011. https://www.510kdatabase.net/k113339/ 2011-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k113339-ortholoc-3dsi-locking-screws-fda-510k.jpg K113339 - ORTHOLOC 3DSI LOCKING SCREWS K113339 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Dec 2011. https://www.510kdatabase.net/k112028/ 2011-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k112028-si-lok-sacroiliac-joint-fixation-system-fda-510k.jpg K112028 - SI-LOK SACROILIAC JOINT FIXATION SYSTEM K112028 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Dec 2011. https://www.510kdatabase.net/k113300/ 2011-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k113300-atb-advance-pta-dilatation-catheter-fda-510k.jpg K113300 - ATB ADVANCE PTA DILATATION CATHETER K113300 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Dec 2011. https://www.510kdatabase.net/k113325/ 2011-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k113325-evolution-mp-adaptive-cs-insert-fda-510k.jpg K113325 - EVOLUTION MP ADAPTIVE CS INSERT K113325 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Dec 2011. https://www.510kdatabase.net/k112208/ 2011-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k112208-intutive-surgical-da-vinci-single-site-fda-510k.jpg K112208 - INTUTIVE SURGICAL DA VINCI SINGLE SITE INSTRUMENTS AND ACCESSORIES K112208 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Dec 2011. https://www.510kdatabase.net/k113227/ 2011-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k113227-non-dehp-micro-volume-extension-set-fda-510k.jpg K113227 - NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER K113227 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Dec 2011. https://www.510kdatabase.net/k113309/ 2011-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k113309-exactech-equinoxe-cage-glenoids-fda-510k.jpg K113309 - EXACTECH EQUINOXE CAGE GLENOIDS K113309 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Dec 2011. https://www.510kdatabase.net/k110457/ 2011-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k110457-3m-tegaderm-matrix-dressing-fda-510k.jpg K110457 - 3M TEGADERM MATRIX DRESSING K110457 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3M Company. Cleared Dec 2011. https://www.510kdatabase.net/k113182/ 2011-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k113182-edwards-lifesciences-intraclude-intra-fda-510k.jpg K113182 - EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER K113182 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Dec 2011. https://www.510kdatabase.net/k111667/ 2011-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k111667-synthes-suprapatellar-insertion-fda-510k.jpg K111667 - SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS K111667 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Dec 2011. https://www.510kdatabase.net/k113350/ 2011-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k113350-brivo-nm-615-fda-510k.jpg K113350 - BRIVO NM 615 K113350 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Dec 2011. https://www.510kdatabase.net/k111751/ 2011-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k111751-versapoint-ii-bipolar-electrosurgery-fda-510k.jpg K111751 - VERSAPOINT II BIPOLAR ELECTROSURGERY GENERATOR, VERSAPOINT II 44MM ANGLED LOOP ELECTRODE, VERSAPOINT II FOOTSWITCH, VERS K111751 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ethicon, Inc.. Cleared Dec 2011. https://www.510kdatabase.net/k113235/ 2011-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k113235-pressure-display-boxdlp-disposable-fda-510k.jpg K113235 - PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS K113235 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Dec 2011. https://www.510kdatabase.net/k110106/ 2011-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k110106-vitek-2-gram-negative-fda-510k.jpg K110106 - VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOAZOLE K110106 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Nov 2011. https://www.510kdatabase.net/k113153/ 2011-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k113153-dp-20-and-dp-30-digital-ultrasonic-fda-510k.jpg K113153 - DP-20 AND DP-30 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM K113153 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Nov 2011. https://www.510kdatabase.net/k112636/ 2011-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k112636-cytoguardtm-closed-luer-connector-fda-510k.jpg K112636 - CYTOGUARD(TM) CLOSED LUER CONNECTOR K112636 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Nov 2011. https://www.510kdatabase.net/k111242/ 2011-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k111242-magnetom-aera-and-magnetom-skyra-fda-510k.jpg K111242 - MAGNETOM AERA AND MAGNETOM SKYRA K111242 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2011. https://www.510kdatabase.net/k112150/ 2011-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k112150-profemur-gladiator-ha-hip-stem-fda-510k.jpg K112150 - PROFEMUR GLADIATOR HA HIP STEM K112150 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Nov 2011. https://www.510kdatabase.net/k103424/ 2011-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k103424-safire-fda-510k.jpg K103424 - SAFIRE K103424 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2011. https://www.510kdatabase.net/k112134/ 2011-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k112134-truclear-operative-hysteroscope-fda-510k.jpg K112134 - TRUCLEAR OPERATIVE HYSTEROSCOPE K112134 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Nov 2011. https://www.510kdatabase.net/k112760/ 2011-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k112760-amsco-v-pro-max-low-temperature-fda-510k.jpg K112760 - AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM K112760 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Nov 2011. https://www.510kdatabase.net/k112784/ 2011-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k112784-renasys-ab-abominal-dressing-kit-fda-510k.jpg K112784 - RENASYS AB ABOMINAL DRESSING KIT K112784 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Nov 2011. https://www.510kdatabase.net/k113027/ 2011-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k113027-syngo-aortic-valveguide-software-fda-510k.jpg K113027 - SYNGO AORTIC VALVEGUIDE SOFTWARE K113027 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2011. https://www.510kdatabase.net/k113052/ 2011-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k113052-infinix-cci-fda-510k.jpg K113052 - INFINIX-CCI K113052 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Nov 2011. https://www.510kdatabase.net/k112097/ 2011-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k112097-gibralt-spine-systems-facet-screw-040045-fda-510k.jpg K112097 - GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5 K112097 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Nov 2011. https://www.510kdatabase.net/k112405/ 2011-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k112405-clydesdales-spinal-system-fda-510k.jpg K112405 - CLYDESDALES SPINAL SYSTEM K112405 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Nov 2011. https://www.510kdatabase.net/k113174/ 2011-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k113174-cd-horizon-spinal-system-fda-510k.jpg K113174 - CD HORIZON SPINAL SYSTEM K113174 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Nov 2011. https://www.510kdatabase.net/k113029/ 2011-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k113029-syngo-via-mi-workflows-fda-510k.jpg K113029 - SYNGO VIA MI WORKFLOWS K113029 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2011. https://www.510kdatabase.net/k111955/ 2011-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k111955-medline-pneumoperitoneum-needle-fda-510k.jpg K111955 - MEDLINE PNEUMOPERITONEUM NEEDLE K111955 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Medline Industries, Inc.. Cleared Nov 2011. https://www.510kdatabase.net/k112406/ 2011-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k112406-peri-loc-proximal-femur-locking-bone-fda-510k.jpg K112406 - PERI-LOC PROXIMAL FEMUR LOCKING BONE PLATES K112406 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Nov 2011. https://www.510kdatabase.net/k113019/ 2011-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k113019-profemur-xm-wingless-distal-fda-510k.jpg K113019 - PROFEMUR XM WINGLESS DISTAL CENTRALIZER, PERFECTA DISTAL CENTRALIZER K113019 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Nov 2011. https://www.510kdatabase.net/k111885/ 2011-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k111885-simplygo-portable-oxygen-concentrator-fda-510k.jpg K111885 - SIMPLYGO PORTABLE OXYGEN CONCENTRATOR K111885 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Nov 2011. https://www.510kdatabase.net/k112603/ 2011-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k112603-access-hybritech-p2psa-qc-on-the-fda-510k.jpg K112603 - ACCESS HYBRITECH P2PSA QC ON THE ACCESS IMMUNOASSAY SYSTEMS K112603 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Nov 2011. https://www.510kdatabase.net/k112185/ 2011-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k112185-foursnare-vascular-retrieval-snare-fda-510k.jpg K112185 - FOURSNARE VASCULAR RETRIEVAL SNARE K112185 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Nov 2011. https://www.510kdatabase.net/k110206/ 2011-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k110206-aesculap-meithke-shunt-system-fda-510k.jpg K110206 - AESCULAP- MEITHKE SHUNT SYSTEM K110206 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Oct 2011. https://www.510kdatabase.net/k112917/ 2011-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k112917-attain-lds-6216a-left-heart-delivery-fda-510k.jpg K112917 - ATTAIN LDS 6216A LEFT HEART DELIVERY SYSTEM, ATTAIN ACCESS 6218A LEFT HEART DELIVERY SYSTEM, ATTAIN 6216A AND 6218A GUID K112917 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Oct 2011. https://www.510kdatabase.net/k112000/ 2011-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k112000-vitek-2-streptococcus-penicillin-fda-510k.jpg K112000 - VITEK 2 STREPTOCOCCUS PENICILLIN K112000 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Oct 2011. https://www.510kdatabase.net/k112174/ 2011-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k112174-ncb-periprosthetic-femur-polyaxial-fda-510k.jpg K112174 - NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM K112174 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Oct 2011. https://www.510kdatabase.net/k112828/ 2011-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k112828-revive-intermediate-catheter-revive-ic-fda-510k.jpg K112828 - REVIVE INTERMEDIATE CATHETER (REVIVE IC) K112828 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Oct 2011. https://www.510kdatabase.net/k112497/ 2011-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k112497-meridian-filter-system-femoral-fda-510k.jpg K112497 - MERIDIAN FILTER SYSTEM - FEMORAL DELIVERY KIT K112497 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 2011. https://www.510kdatabase.net/k103684/ 2011-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k103684-vreselect-culture-medium-fda-510k.jpg K103684 - VRESELECT CULTURE MEDIUM K103684 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bio-Rad. Cleared Oct 2011. https://www.510kdatabase.net/k111414/ 2011-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k111414-quanta-flash-tm-dgp-screen-fda-510k.jpg K111414 - QUANTA FLASH (TM) DGP SCREEN K111414 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Oct 2011. https://www.510kdatabase.net/k112744/ 2011-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k112744-sapiens-tip-confirmation-system-fda-510k.jpg K112744 - SAPIENS TIP CONFIRMATION SYSTEM K112744 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 2011. https://www.510kdatabase.net/k110021/ 2011-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k110021-dash-hip-fda-510k.jpg K110021 - DASH HIP K110021 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Brainlab AG. Cleared Oct 2011. https://www.510kdatabase.net/k111909/ 2011-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k111909-vitek-2-streptococcus-inducible-fda-510k.jpg K111909 - VITEK 2 STREPTOCOCCUS INDUCIBLE CLINDAMYCIN RESISTANCE K111909 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Oct 2011. https://www.510kdatabase.net/k112745/ 2011-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k112745-v-14-control-wire-guidewire-fda-510k.jpg K112745 - V-14 CONTROL WIRE GUIDEWIRE K112745 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Oct 2011. https://www.510kdatabase.net/k103598/ 2011-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k103598-prophecy-pre-operative-navigation-fda-510k.jpg K103598 - PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES K103598 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Oct 2011. https://www.510kdatabase.net/k103627/ 2011-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k103627-architect-icarbamazepine-fda-510k.jpg K103627 - ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS K103627 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Oct 2011. https://www.510kdatabase.net/k103752/ 2011-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k103752-vitek-2-systems-pc-502-software-fda-510k.jpg K103752 - VITEK 2 SYSTEMS (PC) 5.02 SOFTWARE K103752 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Oct 2011. https://www.510kdatabase.net/k110135/ 2011-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k110135-polarcup-dual-mobility-system-fda-510k.jpg K110135 - POLARCUP DUAL MOBILITY SYSTEM K110135 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 2011. https://www.510kdatabase.net/k110586/ 2011-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k110586-advia-centaur-vitamin-d-total-assay-fda-510k.jpg K110586 - ADVIA CENTAUR VITAMIN D TOTAL ASSAY K110586 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Oct 2011. https://www.510kdatabase.net/k111610/ 2011-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k111610-trilogy-series-ventilator-with-oximetry-fda-510k.jpg K111610 - TRILOGY SERIES VENTILATOR WITH OXIMETRY K111610 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Oct 2011. https://www.510kdatabase.net/k111910/ 2011-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k111910-gladiator-hip-stem-fda-510k.jpg K111910 - GLADIATOR HIP STEM K111910 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Oct 2011. https://www.510kdatabase.net/k112694/ 2011-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k112694-edwards-lifesciences-endoclamp-aortic-fda-510k.jpg K112694 - EDWARDS LIFESCIENCES ENDOCLAMP AORTIC CATHETER K112694 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Oct 2011. https://www.510kdatabase.net/k111200/ 2011-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k111200-mac-lab-system-cardiolab-system-fda-510k.jpg K111200 - MAC-LAB SYSTEM, CARDIOLAB SYSTEM, COMBOLAB SYSTEM, SPECIALSLAB SYSTEM K111200 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Healthcare. Cleared Oct 2011. https://www.510kdatabase.net/k111994/ 2011-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k111994-smith-nephew-cannulated-screws-and-fda-510k.jpg K111994 - SMITH & NEPHEW CANNULATED SCREWS AND WASHERS K111994 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 2011. https://www.510kdatabase.net/k112263/ 2011-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k112263-monopolar-curved-scissors-tip-cover-fda-510k.jpg K112263 - MONOPOLAR CURVED SCISSORS TIP COVER ACCESSORY K112263 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Oct 2011. https://www.510kdatabase.net/k112756/ 2011-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k112756-fortifytm-and-fortifytm-r-corpectomy-fda-510k.jpg K112756 - FORTIFY(TM) AND FORTIFY(TM)-R CORPECTOMY SPACERS K112756 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Oct 2011. https://www.510kdatabase.net/k112772/ 2011-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k112772-ortholoctm-bone-screws-fda-510k.jpg K112772 - ORTHOLOC(TM) BONE SCREWS K112772 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Oct 2011. https://www.510kdatabase.net/k110579/ 2011-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k110579-architect-b12-reagents-architect-b12-fda-510k.jpg K110579 - ARCHITECT B12 REAGENTS, ARCHITECT B12 CALIBRATORS, AND ARCHITECT B12 CONTROLS K110579 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Oct 2011. https://www.510kdatabase.net/k111447/ 2011-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k111447-zimmer-periarticular-screws-fda-510k.jpg K111447 - ZIMMER PERIARTICULAR SCREWS K111447 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Oct 2011. https://www.510kdatabase.net/k110870/ 2011-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k110870-aplio-diagnostic-ultrasound-system-fda-510k.jpg K110870 - APLIO DIAGNOSTIC ULTRASOUND SYSTEM K110870 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Oct 2011. https://www.510kdatabase.net/k111606/ 2011-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k111606-pinnacle-precision-access-system-fda-510k.jpg K111606 - PINNACLE PRECISION ACCESS SYSTEM K111606 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Oct 2011. https://www.510kdatabase.net/k112228/ 2011-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k112228-vitek-2-streptococcus-levofloxacin-fda-510k.jpg K112228 - VITEK 2 STREPTOCOCCUS LEVOFLOXACIN K112228 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Oct 2011. https://www.510kdatabase.net/k112584/ 2011-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k112584-5mm8mm-harmonic-acetm-curved-shears-fda-510k.jpg K112584 - 5MM/8MM HARMONIC ACE(TM) CURVED SHEARS, DISPOSABLE HARMONIC ACE(TM) INSERT, DISPOSABLE HARMONIC(TM) CURVED SHEARS INSERT K112584 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Sep 2011. https://www.510kdatabase.net/k112556/ 2011-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k112556-adm-and-admmdm-duration-inserts-adm-fda-510k.jpg K112556 - ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS K112556 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Sep 2011. https://www.510kdatabase.net/k110290/ 2011-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k110290-exeter-hip-stem-fda-510k.jpg K110290 - EXETER HIP STEM K110290 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Sep 2011. https://www.510kdatabase.net/k112129/ 2011-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k112129-vitekr-2-streptococcus-clindamycin-fda-510k.jpg K112129 - VITEK(R) 2 STREPTOCOCCUS CLINDAMYCIN K112129 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Sep 2011. https://www.510kdatabase.net/k112371/ 2011-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k112371-logiq-p3-fda-510k.jpg K112371 - LOGIQ P3 K112371 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Sep 2011. https://www.510kdatabase.net/k112555/ 2011-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k112555-cd-horizonr-spinal-system-fda-510k.jpg K112555 - CD HORIZON(R) SPINAL SYSTEM K112555 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Sep 2011. https://www.510kdatabase.net/k112122/ 2011-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k112122-venue-40-fda-510k.jpg K112122 - VENUE 40 K112122 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Sep 2011. https://www.510kdatabase.net/k101299/ 2011-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k101299-accu-chek-aviva-plus-blood-glucose-fda-510k.jpg K101299 - ACCU-CHEK AVIVA PLUS BLOOD GLUCOSE MONITORING SYSTEM K101299 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Sep 2011. https://www.510kdatabase.net/k111223/ 2011-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k111223-amsco-chimeron-small-steam-sterilizer-fda-510k.jpg K111223 - AMSCO CHIMERON SMALL STEAM STERILIZER K111223 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Sep 2011. https://www.510kdatabase.net/k111912/ 2011-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k111912-mobilett-mira-fda-510k.jpg K111912 - MOBILETT MIRA K111912 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 2011. https://www.510kdatabase.net/k111711/ 2011-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k111711-journey-ii-bcs-knee-system-fda-510k.jpg K111711 - JOURNEY II BCS KNEE SYSTEM K111711 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Sep 2011. https://www.510kdatabase.net/k111457/ 2011-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k111457-cd-horizon-spinal-system-fda-510k.jpg K111457 - CD HORIZON SPINAL SYSTEM K111457 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Sep 2011. https://www.510kdatabase.net/k112075/ 2011-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k112075-vitek-2-strptococcus-ampicillin-fda-510k.jpg K112075 - VITEK 2 STRPTOCOCCUS AMPICILLIN K112075 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Sep 2011. https://www.510kdatabase.net/k103426/ 2011-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k103426-lite-pelvic-floor-repair-kits-fda-510k.jpg K103426 - LITE PELVIC FLOOR REPAIR KITS K103426 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Boston Scientific Corp. Cleared Sep 2011. https://www.510kdatabase.net/k112113/ 2011-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k112113-elecsys-myoglobin-calcheck-5-fda-510k.jpg K112113 - ELECSYS MYOGLOBIN CALCHECK 5 K112113 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Sep 2011. https://www.510kdatabase.net/k112198/ 2011-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k112198-expect-endoscopic-ultrasound-fda-510k.jpg K112198 - EXPECT ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE K112198 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Sep 2011. https://www.510kdatabase.net/k103489/ 2011-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k103489-ge-veo-reconstruction-option-fda-510k.jpg K103489 - GE VEO RECONSTRUCTION OPTION K103489 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Sep 2011. https://www.510kdatabase.net/k111635/ 2011-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k111635-smith-nephew-rj-constrained-liners-fda-510k.jpg K111635 - SMITH & NEPHEW RJ CONSTRAINED LINERS K111635 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Sep 2011. https://www.510kdatabase.net/k111577/ 2011-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k111577-medline-vial-decanter-fda-510k.jpg K111577 - MEDLINE VIAL DECANTER K111577 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Sep 2011. https://www.510kdatabase.net/k110791/ 2011-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k110791-bigliani-flatow-r-the-complete-fda-510k.jpg K110791 - BIGLIANI / FLATOW (R) THE COMPLETE SHOULDER SOLUTION K110791 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Sep 2011. https://www.510kdatabase.net/k111810/ 2011-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k111810-amsco-v-pro-1-and-v-pro-1-plus-low-fda-510k.jpg K111810 - AMSCO V-PRO 1 AND V-PRO 1 PLUS LOW TEMPERATURE STERILIZATION UNITS K111810 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Sep 2011. https://www.510kdatabase.net/k112237/ 2011-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k112237-microsuture-anchors-fda-510k.jpg K112237 - MICROSUTURE ANCHORS K112237 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Sep 2011. https://www.510kdatabase.net/k103331/ 2011-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k103331-verify-biological-indicator-challenge-fda-510k.jpg K103331 - VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION PROCESSES K103331 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Sep 2011. https://www.510kdatabase.net/k112213/ 2011-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k112213-voluson-e6-e8-e8-expert-e10-diagnostic-fda-510k.jpg K112213 - VOLUSON E6, E8, E8 EXPERT, E10 DIAGNOSTIC ULTRASOUND SYSTEM K112213 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Sep 2011. https://www.510kdatabase.net/k111433/ 2011-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k111433-depuy-sttune-tm-ps-knee-system-fda-510k.jpg K111433 - DEPUY STTUNE (TM) PS KNEE SYSTEM K111433 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Aug 2011. https://www.510kdatabase.net/k111942/ 2011-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k111942-tsrh-spinal-systems-fda-510k.jpg K111942 - TSRH SPINAL SYSTEMS K111942 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Aug 2011. https://www.510kdatabase.net/k103308/ 2011-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k103308-aida-hd-connect-with-smartscreen-blu-fda-510k.jpg K103308 - AIDA HD CONNECT WITH SMARTSCREEN / BLU-RAY DRIVE / SMARTSCREEN WITH BLU-RAY DRIVE K103308 is a FDA 510(k) cleared radiology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Aug 2011. https://www.510kdatabase.net/k110451/ 2011-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k110451-endowrist-one-suctionirrigator-fda-510k.jpg K110451 - ENDOWRIST ONE SUCTION/IRRIGATOR K110451 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Aug 2011. https://www.510kdatabase.net/k112137/ 2011-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k112137-comfortglide-intermitent-catheter-fda-510k.jpg K112137 - COMFORTGLIDE INTERMITENT CATHETER K112137 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Aug 2011. https://www.510kdatabase.net/k111633/ 2011-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k111633-aquilion-lb-movement-base-kit-fda-510k.jpg K111633 - AQUILION LB MOVEMENT BASE KIT K111633 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Aug 2011. https://www.510kdatabase.net/k112104/ 2011-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k112104-elecsys-n-mid-osteocalcin-calcheck-5-fda-510k.jpg K112104 - ELECSYS N-MID OSTEOCALCIN CALCHECK 5 K112104 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Aug 2011. https://www.510kdatabase.net/k102511/ 2011-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k102511-meridan-filter-system-fda-510k.jpg K102511 - MERIDAN FILTER SYSTEM- JUNGULAR/SUBECLAVIAN DELIVERY KIT K102511 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Aug 2011. https://www.510kdatabase.net/k110031/ 2011-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k110031-hemosil-drvvt-screen-hemosil-drvvt-fda-510k.jpg K110031 - HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM K110031 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Aug 2011. https://www.510kdatabase.net/k111525/ 2011-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k111525-perimeter-interbody-fusion-device-fda-510k.jpg K111525 - PERIMETER INTERBODY FUSION DEVICE K111525 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Aug 2011. https://www.510kdatabase.net/k111432/ 2011-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k111432-evolve-r-triad-tm-plating-system-and-fda-510k.jpg K111432 - EVOLVE (R) TRIAD (TM) PLATING SYSTEM AND EVOLVE (R) TRIAD (TM) BONE SCREWS K111432 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Aug 2011. https://www.510kdatabase.net/k111661/ 2011-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k111661-arthrex-scapholunate-anchor-fda-510k.jpg K111661 - ARTHREX SCAPHOLUNATE ANCHOR K111661 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Aug 2011. https://www.510kdatabase.net/k111698/ 2011-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k111698-profemurr-e-cementless-hip-stem-fda-510k.jpg K111698 - PROFEMUR(R) E CEMENTLESS HIP STEM K111698 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Aug 2011. https://www.510kdatabase.net/k111699/ 2011-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k111699-profemurr-z-titanium-plasma-sprayed-fda-510k.jpg K111699 - PROFEMUR(R) Z TITANIUM PLASMA SPRAYED HIP STEM K111699 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Aug 2011. https://www.510kdatabase.net/k111952/ 2011-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k111952-access-folate-calibrators-on-the-fda-510k.jpg K111952 - ACCESS FOLATE CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS MODEL A98033 K111952 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Aug 2011. https://www.510kdatabase.net/k102394/ 2011-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k102394-amsco-v-pro-1-low-temperature-fda-510k.jpg K102394 - AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM K102394 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Aug 2011. https://www.510kdatabase.net/k111106/ 2011-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k111106-truebeam-fda-510k.jpg K111106 - TRUEBEAM K111106 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Aug 2011. https://www.510kdatabase.net/k111807/ 2011-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k111807-medline-powder-free-latex-surgical-fda-510k.jpg K111807 - MEDLINE POWDER-FREE LATEX SURGICAL GLOVES, STERILE, W/ OR W/O ALOE VERA, WITH PROTEIN CONTENT LABELING CLAIM... K111807 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Aug 2011. https://www.510kdatabase.net/k110736/ 2011-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k110736-advia-chemistry-ferritin-frt-method-fda-510k.jpg K110736 - ADVIA CHEMISTRY FERRITIN (FRT) METHOD K110736 is a FDA 510(k) cleared immunology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Aug 2011. https://www.510kdatabase.net/k111449/ 2011-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k111449-revolve-additional-implants-fda-510k.jpg K111449 - REVOLVE ADDITIONAL IMPLANTS K111449 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Aug 2011. https://www.510kdatabase.net/k111479/ 2011-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k111479-revere-crosstop-fda-510k.jpg K111479 - REVERE CROSSTOP K111479 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Aug 2011. https://www.510kdatabase.net/k112308/ 2011-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k112308-crosser-recanalization-system-fda-510k.jpg K112308 - CROSSER RECANALIZATION SYSTEM K112308 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Aug 2011. https://www.510kdatabase.net/k110397/ 2011-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k110397-trumatch-personalized-solutions-fda-510k.jpg K110397 - TRUMATCH PERSONALIZED SOLUTIONS K110397 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Aug 2011. https://www.510kdatabase.net/k102330/ 2011-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k102330-amsco-v-pro-max-low-temperature-fda-510k.jpg K102330 - AMSCO V-PRO MAX LOW TEMPERATURE STERILIZATION SYSTEM K102330 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Aug 2011. https://www.510kdatabase.net/k103699/ 2011-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k103699-eactech-optecure-dental-and-optecure-fda-510k.jpg K103699 - EACTECH OPTECURE DENTAL AND OPTECURE DENTAL + CCC K103699 is a FDA 510(k) cleared dental medical device. Manufacturer: Exactech, Inc.. Cleared Aug 2011. https://www.510kdatabase.net/k111599/ 2011-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k111599-vitek-2-ast-st-linezolid-fda-510k.jpg K111599 - VITEK 2 AST-ST LINEZOLID K111599 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Aug 2011. https://www.510kdatabase.net/k112103/ 2011-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k112103-interlock-35-fibered-idc-occlusion-fda-510k.jpg K112103 - INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM K112103 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Aug 2011. https://www.510kdatabase.net/k110543/ 2011-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k110543-crescent-r-spinal-system-titanium-fda-510k.jpg K110543 - CRESCENT (R) SPINAL SYSTEM TITANIUM K110543 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Aug 2011. https://www.510kdatabase.net/k111540/ 2011-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k111540-synthes-35mm-lcp-clavicle-plate-system-fda-510k.jpg K111540 - SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM K111540 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Aug 2011. https://www.510kdatabase.net/k100967/ 2011-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k100967-perimeter-c-spinal-system-fda-510k.jpg K100967 - PERIMETER C SPINAL SYSTEM K100967 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Aug 2011. https://www.510kdatabase.net/k110204/ 2011-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k110204-brainlab-trauma-fda-510k.jpg K110204 - BRAINLAB TRAUMA K110204 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Brainlab AG. Cleared Aug 2011. https://www.510kdatabase.net/k111043/ 2011-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k111043-atlantis-sr-pro2-coronary-imaging-fda-510k.jpg K111043 - ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, ICROSS CORONARY IMAGING CATHETER K111043 is a FDA 510(k) cleared radiology medical device. Manufacturer: Boston Scientific Corp. Cleared Aug 2011. https://www.510kdatabase.net/k111677/ 2011-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k111677-microscanr-microstrep-plusr-fda-510k.jpg K111677 - MICROSCAN(R) MICROSTREP PLUS(R) K111677 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Aug 2011. https://www.510kdatabase.net/k111253/ 2011-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k111253-arthrex-distal-extremity-plate-system-fda-510k.jpg K111253 - ARTHREX DISTAL EXTREMITY PLATE SYSTEM K111253 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Aug 2011. https://www.510kdatabase.net/k110958/ 2011-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k110958-versajet-ii-hydrosurgery-system-fda-510k.jpg K110958 - VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES, VERSAJET FOOTSWITCH K110958 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Aug 2011. https://www.510kdatabase.net/k111556/ 2011-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k111556-glidecross-support-catheter-fda-510k.jpg K111556 - GLIDECROSS SUPPORT CATHETER K111556 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Jul 2011. https://www.510kdatabase.net/k111611/ 2011-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k111611-endomaxx-fully-covered-esophageal-stent-fda-510k.jpg K111611 - ENDOMAXX FULLY COVERED ESOPHAGEAL STENT K111611 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jul 2011. https://www.510kdatabase.net/k111870/ 2011-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k111870-amsco-warming-cabinet-fda-510k.jpg K111870 - AMSCO WARMING CABINET K111870 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Jul 2011. https://www.510kdatabase.net/k110789/ 2011-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k110789-synthes-sternal-zipfix-system-fda-510k.jpg K110789 - SYNTHES STERNAL ZIPFIX SYSTEM K110789 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jul 2011. https://www.510kdatabase.net/k111400/ 2011-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k111400-optetrak-logic-cr-tibial-insert-fda-510k.jpg K111400 - OPTETRAK LOGIC CR TIBIAL INSERT, OPTETRAK LOGIC CR FEMORAL COMPONENT K111400 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Jul 2011. https://www.510kdatabase.net/k111972/ 2011-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k111972-affinity-cp-centrifugal-pump-resting-fda-510k.jpg K111972 - AFFINITY CP CENTRIFUGAL PUMP, RESTING HEART SYS.,MYOTHERM CARDIOPLEGIA DELIV.,AFFINITY HOLLOW FIBER OXYGENATOR,AAF K111972 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Jul 2011. https://www.510kdatabase.net/k111209/ 2011-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k111209-integrated-innova-s5i-system-option-fda-510k.jpg K111209 - INTEGRATED INNOVA - S5I SYSTEM OPTION K111209 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Jul 2011. https://www.510kdatabase.net/k111582/ 2011-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k111582-logiq-s8-fda-510k.jpg K111582 - LOGIQ S8 K111582 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Jul 2011. https://www.510kdatabase.net/k110592/ 2011-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k110592-37mm50mm-dynamic-locking-screw-fda-510k.jpg K110592 - 3.7MM/5.0MM DYNAMIC LOCKING SCREW K110592 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jul 2011. https://www.510kdatabase.net/k111263/ 2011-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k111263-cxi-triforce-fda-510k.jpg K111263 - CXI TRIFORCE K111263 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Jul 2011. https://www.510kdatabase.net/k110943/ 2011-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k110943-logiq-e9-fda-510k.jpg K110943 - LOGIQ E9 K110943 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Jul 2011. https://www.510kdatabase.net/k102405/ 2011-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k102405-infusion-set-for-powerpicc-solo-2-fda-510k.jpg K102405 - INFUSION SET FOR POWERPICC SOLO 2 CATHETER K102405 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jul 2011. https://www.510kdatabase.net/k110201/ 2011-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k110201-explor-radial-head-plating-system-fda-510k.jpg K110201 - EXPLOR RADIAL HEAD PLATING SYSTEM K110201 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jul 2011. https://www.510kdatabase.net/k111552/ 2011-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k111552-elecsys-t3-calcheck-5-fda-510k.jpg K111552 - ELECSYS T3 CALCHECK 5 K111552 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Jul 2011. https://www.510kdatabase.net/k111205/ 2011-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k111205-microscan-r-microstrep-plus-r-panels-fda-510k.jpg K111205 - MICROSCAN (R) MICROSTREP PLUS (R) PANELS K111205 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Jul 2011. https://www.510kdatabase.net/k103129/ 2011-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k103129-entropy-easyfit-sensor-fda-510k.jpg K103129 - ENTROPY EASYFIT SENSOR K103129 is a FDA 510(k) cleared neurology medical device. Manufacturer: Ge Healthcare. Cleared Jul 2011. https://www.510kdatabase.net/k110443/ 2011-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k110443-bd-insyte-autoguard-bc-fda-510k.jpg K110443 - BD INSYTE AUTOGUARD BC K110443 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson & CO. Cleared Jul 2011. https://www.510kdatabase.net/k111147/ 2011-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k111147-medline-vessel-cannula-fda-510k.jpg K111147 - MEDLINE VESSEL CANNULA K111147 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medline Industries, Inc.. Cleared Jul 2011. https://www.510kdatabase.net/k103731/ 2011-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k103731-capstone-r-spinal-system-fda-510k.jpg K103731 - CAPSTONE R SPINAL SYSTEM K103731 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Jul 2011. https://www.510kdatabase.net/k110197/ 2011-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k110197-exactech-gibralt-spinal-system-fda-510k.jpg K110197 - EXACTECH GIBRALT SPINAL SYSTEM K110197 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Jul 2011. https://www.510kdatabase.net/k111850/ 2011-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k111850-vaccess-pta-dilatation-catheter-fda-510k.jpg K111850 - VACCESS PTA DILATATION CATHETER K111850 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jul 2011. https://www.510kdatabase.net/k110670/ 2011-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k110670-vlp-foot-talus-plates-vlp-percutaneous-fda-510k.jpg K110670 - VLP FOOT TALUS PLATES, VLP PERCUTANEOUS CALCANEUS PLATES AND MISC VLP BONE SCREWS, PERI-LOC ANKLE FUSION PLATES K110670 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 2011. https://www.510kdatabase.net/k111077/ 2011-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k111077-orthosorb-resorbable-pins-fda-510k.jpg K111077 - ORTHOSORB RESORBABLE PINS K111077 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jul 2011. https://www.510kdatabase.net/k110237/ 2011-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k110237-hemosil-factor-viii-deficient-plasma-fda-510k.jpg K110237 - HEMOSIL FACTOR VIII DEFICIENT PLASMA K110237 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jul 2011. https://www.510kdatabase.net/k111435/ 2011-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k111435-dp-50-digital-ultrasonic-diagnostic-fda-510k.jpg K111435 - DP-50 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM K111435 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Jul 2011. https://www.510kdatabase.net/k111506/ 2011-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k111506-elecsys-precicontrol-varia-3-fda-510k.jpg K111506 - ELECSYS PRECICONTROL VARIA 3 K111506 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Jul 2011. https://www.510kdatabase.net/k110280/ 2011-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k110280-revlok-fenestrated-screw-system-fda-510k.jpg K110280 - REVLOK FENESTRATED SCREW SYSTEM K110280 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Jul 2011. https://www.510kdatabase.net/k110643/ 2011-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k110643-merit-marquis-flow-switch-fda-510k.jpg K110643 - MERIT MARQUIS FLOW SWITCH K110643 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jul 2011. https://www.510kdatabase.net/k110940/ 2011-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k110940-zimmer-segment-system-trabecular-metal-fda-510k.jpg K110940 - ZIMMER SEGMENT SYSTEM TRABECULAR METAL PROXIMAL TIBIAL COMPONENT, TRABECULAR METAL PROXIMAL COMPONENT, ADDITIONAL SEGMEN K110940 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jul 2011. https://www.510kdatabase.net/k111025/ 2011-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k111025-trigen-low-profile-bone-screw-fda-510k.jpg K111025 - TRIGEN LOW PROFILE BONE SCREW K111025 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 2011. https://www.510kdatabase.net/k102177/ 2011-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k102177-sensicare-powder-free-polymer-coated-fda-510k.jpg K102177 - SENSICARE POWDER-FREE POLYMER COATED POLYSOPRENE SURGICAL GLOVES, STERILE K102177 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Jun 2011. https://www.510kdatabase.net/k103655/ 2011-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k103655-octane-c-interbody-fusion-device-system-fda-510k.jpg K103655 - OCTANE-C INTERBODY FUSION DEVICE SYSTEM K103655 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Jun 2011. https://www.510kdatabase.net/k111485/ 2011-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k111485-fathom-16-steerable-guidewire-model-fda-510k.jpg K111485 - FATHOM 16 STEERABLE GUIDEWIRE MODEL M001509XXX K111485 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Jun 2011. https://www.510kdatabase.net/k111498/ 2011-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k111498-fathom-tm-14-steerable-guidewire-fda-510k.jpg K111498 - FATHOM (TM) 14 STEERABLE GUIDEWIRE K111498 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Jun 2011. https://www.510kdatabase.net/k111674/ 2011-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k111674-acuson-fda-510k.jpg K111674 - ACUSON K111674 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 2011. https://www.510kdatabase.net/k110695/ 2011-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k110695-bipolar-hf-device-fda-510k.jpg K110695 - BIPOLAR HF DEVICE K110695 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Jun 2011. https://www.510kdatabase.net/k111658/ 2011-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k111658-affinity-cp-centrifugal-bllod-pump-fda-510k.jpg K111658 - AFFINITY CP CENTRIFUGAL BLLOD PUMP WITH CARMEDA BIOACTIVE SURFACE K111658 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Jun 2011. https://www.510kdatabase.net/k103520/ 2011-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k103520-carpentier-edwards-physio-tricuspid-fda-510k.jpg K103520 - CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING K103520 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Jun 2011. https://www.510kdatabase.net/k110545/ 2011-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k110545-smith-nephew-next-generation-fully-fda-510k.jpg K110545 - SMITH & NEPHEW NEXT GENERATION FULLY THREADED PEEK SUTURE ANCHOR (NGFTSA PK) K110545 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jun 2011. https://www.510kdatabase.net/k111091/ 2011-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k111091-merit-medical-20-ml-syringe-fda-510k.jpg K111091 - MERIT MEDICAL 20 ML SYRINGE K111091 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jun 2011. https://www.510kdatabase.net/k111657/ 2011-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k111657-affinity-cp-centrifugal-blood-pump-fda-510k.jpg K111657 - AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH BALANCE BIOSURFACE K111657 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Jun 2011. https://www.510kdatabase.net/k110647/ 2011-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k110647-renasys-foam-npwt-wound-dressing-kits-fda-510k.jpg K110647 - RENASYS FOAM NPWT WOUND DRESSING KITS WITH SUCTION PAD K110647 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jun 2011. https://www.510kdatabase.net/k111394/ 2011-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k111394-microscan-microstep-fda-510k.jpg K111394 - MICROSCAN MICROSTEP K111394 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Jun 2011. https://www.510kdatabase.net/k111444/ 2011-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k111444-universal-and-troch-entry-femoral-fda-510k.jpg K111444 - UNIVERSAL AND TROCH ENTRY FEMORAL NAILING SYSTEMS LINE EXTENSION K111444 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jun 2011. https://www.510kdatabase.net/k110194/ 2011-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k110194-medline-epidural-and-spinal-needles-fda-510k.jpg K110194 - MEDLINE EPIDURAL AND SPINAL NEEDLES K110194 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Medline Industries, Inc.. Cleared Jun 2011. https://www.510kdatabase.net/k111100/ 2011-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k111100-encor-enspire-breast-biopsy-system-fda-510k.jpg K111100 - ENCOR ENSPIRE BREAST BIOPSY SYSTEM K111100 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jun 2011. https://www.510kdatabase.net/k111217/ 2011-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k111217-additive-cap-fda-510k.jpg K111217 - ADDITIVE CAP K111217 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jun 2011. https://www.510kdatabase.net/k111244/ 2011-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k111244-turbo-ject-peripherally-inserted-fda-510k.jpg K111244 - TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) K111244 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cook, Inc.. Cleared Jun 2011. https://www.510kdatabase.net/k111023/ 2011-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k111023-abbott-architect-lh-calibrators-fda-510k.jpg K111023 - ABBOTT ARCHITECT LH CALIBRATORS K111023 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jun 2011. https://www.510kdatabase.net/k111349/ 2011-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k111349-elecsys-shbg-calcheck-5-fda-510k.jpg K111349 - ELECSYS SHBG CALCHECK 5 K111349 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Jun 2011. https://www.510kdatabase.net/k103429/ 2011-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k103429-biograph-mmr-fda-510k.jpg K103429 - BIOGRAPH MMR K103429 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 2011. https://www.510kdatabase.net/k110693/ 2011-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k110693-paceart-optima-system-software-fda-510k.jpg K110693 - PACEART OPTIMA SYSTEM SOFTWARE K110693 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Jun 2011. https://www.510kdatabase.net/k111339/ 2011-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k111339-hemostasis-managment-system-plus-hms-fda-510k.jpg K111339 - HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS) K111339 is a FDA 510(k) cleared hematology medical device. Manufacturer: Medtronic, Inc.. Cleared Jun 2011. https://www.510kdatabase.net/k111379/ 2011-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k111379-equinoxe-uhmwpe-12-posterior-augment-fda-510k.jpg K111379 - EQUINOXE UHMWPE 12* POSTERIOR AUGMENT PEGGED GLENOID, SMALL / MEDIUM / LARGE / EXTRA-LARGE, LEFT / RIGHT K111379 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Jun 2011. https://www.510kdatabase.net/k110405/ 2011-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k110405-trublue-nasal-mask-fda-510k.jpg K110405 - TRUBLUE NASAL MASK K110405 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Jun 2011. https://www.510kdatabase.net/k101627/ 2011-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k101627-iplan-fda-510k.jpg K101627 - IPLAN K101627 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Jun 2011. https://www.510kdatabase.net/k110769/ 2011-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k110769-amsco-warming-cabinet-fda-510k.jpg K110769 - AMSCO WARMING CABINET K110769 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Jun 2011. https://www.510kdatabase.net/k111292/ 2011-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k111292-luminos-agile-fda-510k.jpg K111292 - LUMINOS AGILE K111292 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 2011. https://www.510kdatabase.net/k111445/ 2011-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k111445-discovery-nm-630-fda-510k.jpg K111445 - DISCOVERY NM 630 K111445 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Jun 2011. https://www.510kdatabase.net/k103548/ 2011-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k103548-advia-centaur-calibarator-80-model-fda-510k.jpg K103548 - ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491 K103548 is a FDA 510(k) cleared immunology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Jun 2011. https://www.510kdatabase.net/k111252/ 2011-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k111252-acuity-tm-cut-away-tm-guide-catheters-fda-510k.jpg K111252 - ACUITY (TM) CUT-AWAY (TM) GUIDE CATHETERS 6F AND 8F K111252 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Jun 2011. https://www.510kdatabase.net/k110398/ 2011-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k110398-respironics-disposable-heated-wire-fda-510k.jpg K110398 - RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS K110398 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Jun 2011. https://www.510kdatabase.net/k111295/ 2011-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k111295-014-monorail-and-otw-pta-balloon-fda-510k.jpg K111295 - .014 MONORAIL AND OTW PTA BALLOON DILATATION CATHETERS K111295 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared May 2011. https://www.510kdatabase.net/k110251/ 2011-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k110251-synchron-multi-calibrator-fda-510k.jpg K110251 - SYNCHRON MULTI CALIBRATOR K110251 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared May 2011. https://www.510kdatabase.net/k111153/ 2011-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k111153-sorbafix-tm-absorbable-fixation-system-fda-510k.jpg K111153 - SORBAFIX (TM) ABSORBABLE FIXATION SYSTEM, PERMAFIX (TM) FIXATION SYSTEM K111153 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 2011. https://www.510kdatabase.net/k111336/ 2011-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k111336-ebw-nm-20-fda-510k.jpg K111336 - EBW NM 2.0 K111336 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared May 2011. https://www.510kdatabase.net/k103500/ 2011-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k103500-gore-embolic-filter-fda-510k.jpg K103500 - GORE EMBOLIC FILTER K103500 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared May 2011. https://www.510kdatabase.net/k110676/ 2011-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k110676-tsrh-spinal-system-fda-510k.jpg K110676 - TSRH SPINAL SYSTEM K110676 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared May 2011. https://www.510kdatabase.net/k102740/ 2011-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k102740-nuclisens-easyq-mrsa-fda-510k.jpg K102740 - NUCLISENS EASYQ MRSA K102740 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared May 2011. https://www.510kdatabase.net/k103382/ 2011-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k103382-intercontinental-plate-spacer-fda-510k.jpg K103382 - INTERCONTINENTAL PLATE-SPACER K103382 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared May 2011. https://www.510kdatabase.net/k103603/ 2011-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k103603-zeus-elisa-hsv-gg-2-igg-test-system-fda-510k.jpg K103603 - ZEUS ELISA HSV GG-2 IGG TEST SYSTEM K103603 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared May 2011. https://www.510kdatabase.net/k111052/ 2011-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k111052-syngo-neuro-pbv-ir-fda-510k.jpg K111052 - SYNGO NEURO PBV-IR K111052 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 2011. https://www.510kdatabase.net/k111039/ 2011-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k111039-zimmer-periarticular-locking-plate-fda-510k.jpg K111039 - ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM K111039 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared May 2011. https://www.510kdatabase.net/k101946/ 2011-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k101946-vidas-toxo-igg-avidity-fda-510k.jpg K101946 - VIDAS TOXO IGG AVIDITY K101946 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared May 2011. https://www.510kdatabase.net/k102251/ 2011-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k102251-dash-knee-fda-510k.jpg K102251 - DASH KNEE K102251 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Brainlab AG. Cleared May 2011. https://www.510kdatabase.net/k103094/ 2011-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k103094-vigileo-arterial-pressure-cardiac-fda-510k.jpg K103094 - VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT / OXIMETRY MONITOR K103094 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared May 2011. https://www.510kdatabase.net/k110706/ 2011-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k110706-exactech-equinoxe-cuff-tear-fda-510k.jpg K110706 - EXACTECH EQUINOXE CUFF TEAR ARTHROPLASTY (CTA) HEAD K110706 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared May 2011. https://www.510kdatabase.net/k110540/ 2011-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k110540-terumo-support-catheter-fda-510k.jpg K110540 - TERUMO SUPPORT CATHETER K110540 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared May 2011. https://www.510kdatabase.net/k103716/ 2011-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k103716-roche-elecsys-folate-rbc-fda-510k.jpg K103716 - ROCHE ELECSYS FOLATE RBC K103716 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared May 2011. https://www.510kdatabase.net/k110613/ 2011-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k110613-elecsys-prolactin-ii-calcheck-5-fda-510k.jpg K110613 - ELECSYS PROLACTIN II CALCHECK 5 K110613 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared May 2011. https://www.510kdatabase.net/k110409/ 2011-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k110409-aspira-pleural-drainage-system-fda-510k.jpg K110409 - ASPIRA PLEURAL DRAINAGE SYSTEM K110409 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 2011. https://www.510kdatabase.net/k110413/ 2011-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k110413-power-processor-sample-processing-fda-510k.jpg K110413 - POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTIONS K110413 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared May 2011. https://www.510kdatabase.net/k103718/ 2011-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k103718-dynacor-lubrication-gel-fda-510k.jpg K103718 - DYNACOR LUBRICATION GEL K103718 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared May 2011. https://www.510kdatabase.net/k110399/ 2011-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k110399-gladiator-plasma-classic-hip-stem-fda-510k.jpg K110399 - GLADIATOR PLASMA CLASSIC HIP STEM K110399 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared May 2011. https://www.510kdatabase.net/k110751/ 2011-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k110751-codman-bactiseal-endoscopic-venticular-fda-510k.jpg K110751 - CODMAN BACTISEAL ENDOSCOPIC VENTICULAR CATHETER K110751 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared May 2011. https://www.510kdatabase.net/k102568/ 2011-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k102568-uric-acid-model-3p39-fda-510k.jpg K102568 - URIC ACID MODEL 3P39 K102568 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared May 2011. https://www.510kdatabase.net/k110396/ 2011-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k110396-aspira-peritoneal-drainage-system-fda-510k.jpg K110396 - ASPIRA PERITONEAL DRAINAGE SYSTEM K110396 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 2011. https://www.510kdatabase.net/k103835/ 2011-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k103835-reunion-tsa-system-humeral-press-fit-fda-510k.jpg K103835 - REUNION TSA SYSTEM-HUMERAL PRESS-FIT & CEMENTED STEMS MODEL 5569-YY-20XX (YY=P,C K103835 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared May 2011. https://www.510kdatabase.net/k110875/ 2011-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k110875-centricity-pacs-fda-510k.jpg K110875 - CENTRICITY PACS K110875 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared May 2011. https://www.510kdatabase.net/k110963/ 2011-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k110963-ellipse-occipito-cervico-thoracic-fda-510k.jpg K110963 - ELLIPSE OCCIPITO-CERVICO-THORACIC SPINAL SYSTEM K110963 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared May 2011. https://www.510kdatabase.net/k102324/ 2011-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k102324-endofuse-intra-osseous-fusion-system-fda-510k.jpg K102324 - ENDOFUSE INTRA-OSSEOUS FUSION SYSTEM K102324 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared May 2011. https://www.510kdatabase.net/k102681/ 2011-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k102681-advia-centaur-toxoplasma-igg-toxo-g-fda-510k.jpg K102681 - ADVIA CENTAUR TOXOPLASMA IGG (TOXO G) K102681 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared May 2011. https://www.510kdatabase.net/k103764/ 2011-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k103764-reveal-xt-insertable-cardiac-monitor-fda-510k.jpg K103764 - REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529 AND REVEAL DX INSERTABLE CARDIAC MONITOR, MODEL 9528 K103764 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared May 2011. https://www.510kdatabase.net/k110446/ 2011-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k110446-roche-oral-fluid-amphetamine-roche-fda-510k.jpg K110446 - ROCHE ORAL FLUID AMPHETAMINE, ROCHE ORAL FLUID DAT QUAL CAL B, ROCHE ORAL FLUID DAT CONTROL SET B, AND ROCHE ORAL FLUID K110446 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics. Cleared May 2011. https://www.510kdatabase.net/k103793/ 2011-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k103793-durafiber-ag-fda-510k.jpg K103793 - DURAFIBER AG K103793 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared May 2011. https://www.510kdatabase.net/k110909/ 2011-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k110909-emboshield-nav6-embolic-protection-fda-510k.jpg K110909 - EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM, BAREWIRE FILTER DELIVERY WIRE-WORKHORSE-190CM / 315CM, BAREWIRE FILTER DEL.. K110909 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Laboratories. Cleared Apr 2011. https://www.510kdatabase.net/k110123/ 2011-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k110123-pcl-tightrope-fda-510k.jpg K110123 - PCL TIGHTROPE K110123 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Apr 2011. https://www.510kdatabase.net/k103842/ 2011-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k103842-unicel-dxc-600-synchron-system-fda-510k.jpg K103842 - UNICEL DXC 600 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 AND UNICEL DXC 800 SYNCHRON SYSTEM SOFTWARE VERSION 5.0 K103842 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Apr 2011. https://www.510kdatabase.net/k103363/ 2011-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k103363-zeus-elisa-hsv-gc-i-igg-test-system-fda-510k.jpg K103363 - ZEUS ELISA HSV GC-I IGG TEST SYSTEM K103363 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Apr 2011. https://www.510kdatabase.net/k110834/ 2011-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k110834-aw-volumeshare-5-with-angioviz-option-fda-510k.jpg K110834 - AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION K110834 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Apr 2011. https://www.510kdatabase.net/k110837/ 2011-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k110837-revision-prothesis-fda-510k.jpg K110837 - REVISION PROTHESIS K110837 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Apr 2011. https://www.510kdatabase.net/k103602/ 2011-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k103602-eudermic-mp-latex-examination-glove-fda-510k.jpg K103602 - EUDERMIC MP LATEX EXAMINATION GLOVE-BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) W/ A PROTEIN CONTENT LABEL CLAIM K103602 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Apr 2011. https://www.510kdatabase.net/k110125/ 2011-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k110125-24-mm-va-lcp-volar-rim-distal-radius-fda-510k.jpg K110125 - 2.4 MM VA-LCP VOLAR RIM DISTAL RADIUS SYSTEM K110125 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Apr 2011. https://www.510kdatabase.net/k111024/ 2011-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k111024-jetpack-20-fda-510k.jpg K111024 - JETPACK 2.0 K111024 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Apr 2011. https://www.510kdatabase.net/k110833/ 2011-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k110833-cre-balloon-dilatation-catheter-fda-510k.jpg K110833 - CRE BALLOON DILATATION CATHETER K110833 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Apr 2011. https://www.510kdatabase.net/k110844/ 2011-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k110844-symbianet-fda-510k.jpg K110844 - SYMBIA.NET K110844 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 2011. https://www.510kdatabase.net/k110029/ 2011-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k110029-conserve-bio-foam-shell-fda-510k.jpg K110029 - CONSERVE BIO FOAM SHELL K110029 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Apr 2011. https://www.510kdatabase.net/k103606/ 2011-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k103606-artiste-solution-with-sysvb50-update-fda-510k.jpg K103606 - ARTISTE SOLUTION WITH SYS_VB50 UPDATE K103606 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 2011. https://www.510kdatabase.net/k103662/ 2011-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k103662-continuum-and-trilogy-integrated-taper-fda-510k.jpg K103662 - CONTINUUM AND TRILOGY INTEGRATED TAPER (IT) ACETABULAR SYSTEMS K103662 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Apr 2011. https://www.510kdatabase.net/k110240/ 2011-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k110240-smith-nephew-inc-sureshot-distal-fda-510k.jpg K110240 - SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.1 K110240 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Apr 2011. https://www.510kdatabase.net/k110887/ 2011-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k110887-injection-gold-probe-bipolar-fda-510k.jpg K110887 - INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER K110887 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Apr 2011. https://www.510kdatabase.net/k110259/ 2011-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k110259-architex-space-maintenance-system-fda-510k.jpg K110259 - ARCHITEX SPACE MAINTENANCE SYSTEM K110259 is a FDA 510(k) cleared dental medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Apr 2011. https://www.510kdatabase.net/k101072/ 2011-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k101072-tritanium-peri-apatitie-acetabular-fda-510k.jpg K101072 - TRITANIUM PERI-APATITIE ACETABULAR SOLID-BACKED SHELL, TRITANIUM PERI-APATITE K101072 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Apr 2011. https://www.510kdatabase.net/k110101/ 2011-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k110101-taper-oxinium-femoral-head-fda-510k.jpg K110101 - TAPER OXINIUM FEMORAL HEAD K110101 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Apr 2011. https://www.510kdatabase.net/k101581/ 2011-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k101581-intuitive-surgical-da-vinci-s-surgical-fda-510k.jpg K101581 - INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM WITH DA VINCI CONNECT & DA VINCI ONSITE, MODEL IS2000 K101581 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Apr 2011. https://www.510kdatabase.net/k110479/ 2011-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k110479-acuity-whisper-view-guide-wires-fda-510k.jpg K110479 - ACUITY WHISPER VIEW GUIDE WIRES K110479 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Apr 2011. https://www.510kdatabase.net/k100375/ 2011-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k100375-dimension-vista-loci-ca-19-9-flex-fda-510k.jpg K100375 - DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC604 K100375 is a FDA 510(k) cleared immunology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Apr 2011. https://www.510kdatabase.net/k110494/ 2011-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k110494-syngo-mbf-fda-510k.jpg K110494 - SYNGO MBF K110494 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 2011. https://www.510kdatabase.net/k110744/ 2011-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k110744-prontosan-wound-irrigation-solution-fda-510k.jpg K110744 - PRONTOSAN WOUND IRRIGATION SOLUTION K110744 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Apr 2011. https://www.510kdatabase.net/k102552/ 2011-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k102552-hemosil-la-positive-control-fda-510k.jpg K102552 - HEMOSIL LA POSITIVE CONTROL K102552 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Apr 2011. https://www.510kdatabase.net/k102985/ 2011-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k102985-v60-ventilator-with-ppv-and-auto-trak-fda-510k.jpg K102985 - V60 VENTILATOR WITH PPV AND AUTO-TRAK+ SOFTWARE OPTIONS K102985 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Apr 2011. https://www.510kdatabase.net/k102990/ 2011-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k102990-brainlab-knee-fda-510k.jpg K102990 - BRAINLAB KNEE K102990 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Brainlab AG. Cleared Apr 2011. https://www.510kdatabase.net/k101722/ 2011-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k101722-alyte-y-mesh-graft-fda-510k.jpg K101722 - ALYTE Y-MESH GRAFT K101722 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 2011. https://www.510kdatabase.net/k102699/ 2011-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k102699-architect-igentamicin-reagents-fda-510k.jpg K102699 - ARCHITECT IGENTAMICIN REAGENTS K102699 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Apr 2011. https://www.510kdatabase.net/k110522/ 2011-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k110522-vertex-reconstruction-system-vertex-fda-510k.jpg K110522 - VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM K110522 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Apr 2011. https://www.510kdatabase.net/k110708/ 2011-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k110708-equinoxe-reverse-shoulder-compression-fda-510k.jpg K110708 - EQUINOXE REVERSE SHOULDER COMPRESSION SCREW / 38MM AND 42MM GLENOSPHERE / SUPERIOR AUGMENT GLENOID PLATE, 10 DEGREES... K110708 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Apr 2011. https://www.510kdatabase.net/k110820/ 2011-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k110820-ventralight-tm-st-mesh-with-echo-ps-tm-fda-510k.jpg K110820 - VENTRALIGHT (TM) ST MESH WITH ECHO PS (TM) POSITIONING SYSTEM K110820 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 2011. https://www.510kdatabase.net/k110660/ 2011-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k110660-arthrex-biocomposite-suturetak-fda-510k.jpg K110660 - ARTHREX BIOCOMPOSITE SUTURETAK K110660 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Mar 2011. https://www.510kdatabase.net/k102936/ 2011-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k102936-homechoicehomechoice-pro-automated-fda-510k.jpg K102936 - HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310R K102936 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 2011. https://www.510kdatabase.net/k110038/ 2011-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k110038-truclear-morcellator-system-fda-510k.jpg K110038 - TRUCLEAR MORCELLATOR SYSTEM K110038 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Mar 2011. https://www.510kdatabase.net/k110685/ 2011-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k110685-flexiva-tractip-fda-510k.jpg K110685 - FLEXIVA TRACTIP K110685 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Boston Scientific Corp. Cleared Mar 2011. https://www.510kdatabase.net/k093987/ 2011-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k093987-immulite-2000-3g-allergy-specific-ige-fda-510k.jpg K093987 - IMMULITE 2000 3G ALLERGY SPECIFIC IGE ASSAY KIT MODEL L2KUN6 K093987 is a FDA 510(k) cleared immunology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Mar 2011. https://www.510kdatabase.net/k110686/ 2011-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k110686-accutrac-fda-510k.jpg K110686 - ACCUTRAC K110686 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Boston Scientific Corp. Cleared Mar 2011. https://www.510kdatabase.net/k101560/ 2011-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k101560-medline-retractable-safety-syringe-fda-510k.jpg K101560 - MEDLINE RETRACTABLE SAFETY SYRINGE K101560 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Mar 2011. https://www.510kdatabase.net/k103389/ 2011-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k103389-truclear-incisor-plus-blade-29-fda-510k.jpg K103389 - TRUCLEAR INCISOR PLUS BLADE 2.9 K103389 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Mar 2011. https://www.510kdatabase.net/k103551/ 2011-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k103551-interlink-s-clearlink-system-v-link-fda-510k.jpg K103551 - INTERLINK S / CLEARLINK SYSTEM / V-LINK LAD WITH VITALSHIELD PROTECTIVE COATING NON-DEHP CATHETER EXTENSION SET KITS, K103551 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 2011. https://www.510kdatabase.net/k102465/ 2011-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k102465-bipap-avaps-ventilatory-support-system-fda-510k.jpg K102465 - BIPAP AVAPS VENTILATORY SUPPORT SYSTEM K102465 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Mar 2011. https://www.510kdatabase.net/k103170/ 2011-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k103170-gmk-revision-knee-sc-liners-fda-510k.jpg K103170 - GMK REVISION KNEE SC LINERS K103170 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Mar 2011. https://www.510kdatabase.net/k103395/ 2011-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k103395-performax-total-face-mask-fda-510k.jpg K103395 - PERFORMAX TOTAL FACE MASK K103395 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Mar 2011. https://www.510kdatabase.net/k101644/ 2011-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k101644-quanta-flash-h-ttg-igg-fda-510k.jpg K101644 - QUANTA FLASH H-TTG IGG K101644 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Mar 2011. https://www.510kdatabase.net/k101920/ 2011-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k101920-ventrio-st-hernia-patch-fda-510k.jpg K101920 - VENTRIO ST HERNIA PATCH K101920 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 2011. https://www.510kdatabase.net/k101928/ 2011-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k101928-ventralex-st-hernia-patch-fda-510k.jpg K101928 - VENTRALEX ST HERNIA PATCH K101928 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 2011. https://www.510kdatabase.net/k103245/ 2011-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k103245-celstat-fda-510k.jpg K103245 - CELSTAT K103245 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 2011. https://www.510kdatabase.net/k110552/ 2011-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k110552-valorr-ankle-fusion-nail-system-screw-fda-510k.jpg K110552 - VALOR(R) ANKLE FUSION NAIL SYSTEM SCREW K110552 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Mar 2011. https://www.510kdatabase.net/k103411/ 2011-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k103411-ideal-iq-software-option-fda-510k.jpg K103411 - IDEAL IQ SOFTWARE OPTION K103411 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Mar 2011. https://www.510kdatabase.net/k102779/ 2011-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k102779-emit-ii-plus6-acetylmorphine-assay-fda-510k.jpg K102779 - EMIT II PLUS6-ACETYLMORPHINE ASSAY K102779 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Mar 2011. https://www.510kdatabase.net/k103705/ 2011-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k103705-low-profile-screws-fda-510k.jpg K103705 - LOW PROFILE SCREWS K103705 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Mar 2011. https://www.510kdatabase.net/k103798/ 2011-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k103798-bd-probetec-herpes-simplex-viruses-hsv-fda-510k.jpg K103798 - BD PROBETEC HERPES SIMPLEX VIRUSES (HSV 1& 2) Q AMPLIFIED DNA ASSAYS K103798 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Mar 2011. https://www.510kdatabase.net/k102164/ 2011-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k102164-hemosil-protein-s-activity-assay-fda-510k.jpg K102164 - HEMOSIL PROTEIN S ACTIVITY ASSAY K102164 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Mar 2011. https://www.510kdatabase.net/k103072/ 2011-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k103072-revere-sacral-plates-fda-510k.jpg K103072 - REVERE SACRAL PLATES K103072 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Mar 2011. https://www.510kdatabase.net/k103246/ 2011-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k103246-iplan-rt-fda-510k.jpg K103246 - IPLAN RT K103246 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab AG. Cleared Mar 2011. https://www.510kdatabase.net/k110453/ 2011-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k110453-reliance-endoscope-processing-system-fda-510k.jpg K110453 - RELIANCE ENDOSCOPE PROCESSING SYSTEM K110453 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Mar 2011. https://www.510kdatabase.net/k103756/ 2011-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k103756-depuy-attune-total-knee-system-fda-510k.jpg K103756 - DEPUY ATTUNE TOTAL KNEE SYSTEM K103756 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Mar 2011. https://www.510kdatabase.net/k100569/ 2011-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k100569-merit-embolectomy-catheter-model-asap100-fda-510k.jpg K100569 - MERIT EMBOLECTOMY CATHETER MODEL ASAP100 K100569 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Mar 2011. https://www.510kdatabase.net/k093736/ 2011-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k093736-depuy-corail-hip-system-revision-stem-fda-510k.jpg K093736 - DEPUY CORAIL HIP SYSTEM, REVISION STEM K093736 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Mar 2011. https://www.510kdatabase.net/k103053/ 2011-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k103053-verify-270fp-challenge-pack-fda-510k.jpg K103053 - VERIFY 270FP CHALLENGE PACK K103053 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Mar 2011. https://www.510kdatabase.net/k103649/ 2011-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k103649-voluson-s6-voluson-s8-fda-510k.jpg K103649 - VOLUSON S6, VOLUSON S8 K103649 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Mar 2011. https://www.510kdatabase.net/k102064/ 2011-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k102064-bd-facs-sample-prep-assistant-iii-spa-fda-510k.jpg K102064 - BD FACS SAMPLE PREP ASSISTANT III (SPA III) K102064 is a FDA 510(k) cleared hematology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Mar 2011. https://www.510kdatabase.net/k103335/ 2011-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k103335-gem-option-for-15-mri-systems-fda-510k.jpg K103335 - GEM OPTION FOR 1.5 MRI SYSTEMS K103335 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Mar 2011. https://www.510kdatabase.net/k103127/ 2011-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k103127-somatom-definition-as-fda-510k.jpg K103127 - SOMATOM DEFINITION AS K103127 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2011. https://www.510kdatabase.net/k103458/ 2011-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k103458-viewpoint-6-fda-510k.jpg K103458 - VIEWPOINT 6 K103458 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Mar 2011. https://www.510kdatabase.net/k110145/ 2011-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k110145-biomet-sports-medicine-juggerknot-soft-fda-510k.jpg K110145 - BIOMET SPORTS MEDICINE JUGGERKNOT SOFT ANCHOR K110145 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Mar 2011. https://www.510kdatabase.net/k110354/ 2011-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k110354-45mm-va-lcp-curved-condylar-plate-system-fda-510k.jpg K110354 - 4.5MM VA-LCP CURVED CONDYLAR PLATE SYSTEM K110354 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Mar 2011. https://www.510kdatabase.net/k093830/ 2011-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k093830-medline-angiographic-control-syringe-fda-510k.jpg K093830 - MEDLINE ANGIOGRAPHIC CONTROL SYRINGE K093830 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medline Industries, Inc.. Cleared Mar 2011. https://www.510kdatabase.net/k110295/ 2011-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k110295-interlock-35-fibered-idc-occlusion-fda-510k.jpg K110295 - INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM K110295 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Mar 2011. https://www.510kdatabase.net/k103002/ 2011-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k103002-synthes-multiloc-proximal-humeral-fda-510k.jpg K103002 - SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM K103002 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Mar 2011. https://www.510kdatabase.net/k093884/ 2011-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k093884-roche-fludi-methamphetamine-fda-510k.jpg K093884 - ROCHE FLUDI METHAMPHETAMINE K093884 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics. Cleared Feb 2011. https://www.510kdatabase.net/k110163/ 2011-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k110163-approach-pro-st-wire-guide-fda-510k.jpg K110163 - APPROACH PRO ST WIRE GUIDE K110163 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Feb 2011. https://www.510kdatabase.net/k102125/ 2011-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k102125-patient-specific-vanguard-femoral-fda-510k.jpg K102125 - PATIENT-SPECIFIC VANGUARD FEMORAL COMPONETS K102125 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Feb 2011. https://www.510kdatabase.net/k102961/ 2011-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k102961-holter-in-line-shunt-filter-holter-fda-510k.jpg K102961 - HOLTER IN-LINE SHUNT FILTER, HOLTER CEREBRAL CATHETER RESERVOIR, ACCU-FLO CONNECTORS K102961 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Feb 2011. https://www.510kdatabase.net/k103226/ 2011-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k103226-sterilization-mats-fda-510k.jpg K103226 - STERILIZATION MATS K103226 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Feb 2011. https://www.510kdatabase.net/k103701/ 2011-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k103701-advia-chemistry-liquid-specific-fda-510k.jpg K103701 - ADVIA CHEMISTRY LIQUID SPECIFIC PROTEIN CALIBRATORS K103701 is a FDA 510(k) cleared immunology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Feb 2011. https://www.510kdatabase.net/k110167/ 2011-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k110167-presep-oligon-oximetry-catheters-16-cm-fda-510k.jpg K110167 - PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN) K110167 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Feb 2011. https://www.510kdatabase.net/k103001/ 2011-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k103001-rockwood-clavicle-pins-fda-510k.jpg K103001 - ROCKWOOD CLAVICLE PINS K103001 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Feb 2011. https://www.510kdatabase.net/k110008/ 2011-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k110008-golife-nasal-mask-fda-510k.jpg K110008 - GOLIFE NASAL MASK K110008 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Feb 2011. https://www.510kdatabase.net/k103355/ 2011-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k103355-gdc-360-deteachable-coil-fda-510k.jpg K103355 - GDC 360 DETEACHABLE COIL K103355 is a FDA 510(k) cleared neurology medical device. Manufacturer: Boston Scientific Corp. Cleared Feb 2011. https://www.510kdatabase.net/k103836/ 2011-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k103836-enzyme-ii-calibrator-fda-510k.jpg K103836 - ENZYME II CALIBRATOR K103836 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Feb 2011. https://www.510kdatabase.net/k093867/ 2011-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k093867-roche-oral-fluid-opiates-dat-qual-cal-fda-510k.jpg K093867 - ROCHE ORAL FLUID OPIATES, DAT QUAL CAL A, DAT CONTROL SET A AND DAT SQ CAL A K093867 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Feb 2011. https://www.510kdatabase.net/k101160/ 2011-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k101160-roche-oral-fluid-cocaine-fda-510k.jpg K101160 - ROCHE ORAL FLUID COCAINE K101160 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Feb 2011. https://www.510kdatabase.net/k102714/ 2011-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k102714-complex-helical-18-multi-loop-18-fda-510k.jpg K102714 - COMPLEX HELICAL 18, MULTI-LOOP 18, FIGURE 8-18, STRAIGHT 18 FIBERED PLATINUM COILS, VORTX -18, VORTX 35 & 2D HELICAL K102714 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Feb 2011. https://www.510kdatabase.net/k103171/ 2011-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k103171-elecsys-anti-tpo-calset-fda-510k.jpg K103171 - ELECSYS ANTI-TPO CALSET K103171 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics. Cleared Feb 2011. https://www.510kdatabase.net/k103386/ 2011-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k103386-medtronic-vascular-hub-material-fda-510k.jpg K103386 - MEDTRONIC VASCULAR - HUB MATERIAL MODIFICATION TO THE 5F AND 8F LAUNCHER(R) GUIDE CATHETERS K103386 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Feb 2011. https://www.510kdatabase.net/k110103/ 2011-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k110103-edwards-lifesciences-left-atrial-fda-510k.jpg K110103 - EDWARDS LIFESCIENCES LEFT ATRIAL PRESSURE MONITOR CATHETER K110103 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Feb 2011. https://www.510kdatabase.net/k102283/ 2011-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k102283-zeus-scientific-inc-treponema-pallidum-fda-510k.jpg K102283 - ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM K102283 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Feb 2011. https://www.510kdatabase.net/k102296/ 2011-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k102296-verify-chemical-monitoring-strip-for-fda-510k.jpg K102296 - VERIFY CHEMICAL MONITORING STRIP FOR RESERT SOULTIONS (RESERT XL TEST STRIP VERSION 2) K102296 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Feb 2011. https://www.510kdatabase.net/k101236/ 2011-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k101236-voluson-e6e8e8-expert-diagnostic-fda-510k.jpg K101236 - VOLUSON E6/E8/E8 EXPERT DIAGNOSTIC ULTRASOUND SYSTEM MODEL: H48681BD/ H48681BX/ H48681BM K101236 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Feb 2011. https://www.510kdatabase.net/k110069/ 2011-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k110069-smith-nephew-inc-spatialframe-v41-web-fda-510k.jpg K110069 - SMITH & NEPHEW, INC SPATIALFRAME V4.1 WEB-BASED SOFTWARE K110069 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Feb 2011. https://www.510kdatabase.net/k110199/ 2011-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k110199-dc-t6-diagnostic-ultrasound-system-fda-510k.jpg K110199 - DC-T6 DIAGNOSTIC ULTRASOUND SYSTEM K110199 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Feb 2011. https://www.510kdatabase.net/k103373/ 2011-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k103373-synchron-systems-cholinesterase-chex-fda-510k.jpg K103373 - SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722 K103373 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Feb 2011. https://www.510kdatabase.net/k101077/ 2011-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k101077-da-vinci-fluorescence-imaging-vision-fda-510k.jpg K101077 - DA VINCI FLUORESCENCE IMAGING VISION SYSTEM, MODEL FF 100 K101077 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Feb 2011. https://www.510kdatabase.net/k101743/ 2011-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k101743-5mm-flared-cannula-model-420262-8mm-fda-510k.jpg K101743 - 5MM FLARED CANNULA MODEL 420262, 8MM FLARED CANNULA MODEL 420319 K101743 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Feb 2011. https://www.510kdatabase.net/k103403/ 2011-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k103403-multiconstituent-calibrator-fda-510k.jpg K103403 - MULTICONSTITUENT CALIBRATOR K103403 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Feb 2011. https://www.510kdatabase.net/k103233/ 2011-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k103233-modular-dual-mobility-liner-x3-fda-510k.jpg K103233 - MODULAR DUAL MOBILITY LINER, X3 ACETABULAR INSERT K103233 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Feb 2011. https://www.510kdatabase.net/k103629/ 2011-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k103629-pet-512mc-transesophageal-transducer-fda-510k.jpg K103629 - PET-512MC TRANSESOPHAGEAL TRANSDUCER K103629 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Feb 2011. https://www.510kdatabase.net/k110009/ 2011-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k110009-roadrunner-uniglide-hydrophilic-wire-fda-510k.jpg K110009 - ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE K110009 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Feb 2011. https://www.510kdatabase.net/k103256/ 2011-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k103256-smith-nephew-smf-hip-stem-fda-510k.jpg K103256 - SMITH & NEPHEW SMF HIP STEM K103256 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jan 2011. https://www.510kdatabase.net/k103677/ 2011-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k103677-m7m7t-diagnostic-ultrasound-system-fda-510k.jpg K103677 - M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM K103677 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Jan 2011. https://www.510kdatabase.net/k101459/ 2011-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k101459-osteoraptor-ii-suture-anchor-or-to-be-fda-510k.jpg K101459 - OSTEORAPTOR II SUTURE ANCHOR OR TO BE DETERMINED MODEL: 72202764 72202765 72202766 72202767 72202768 72202769 72202770 K101459 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jan 2011. https://www.510kdatabase.net/k093989/ 2011-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k093989-oral-fluid-phencyclidine-fda-510k.jpg K093989 - ORAL FLUID PHENCYCLIDINE K093989 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Jan 2011. https://www.510kdatabase.net/k103612/ 2011-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k103612-dimension-visa-enz-2-cal-fda-510k.jpg K103612 - DIMENSION VISA ENZ 2 CAL K103612 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Jan 2011. https://www.510kdatabase.net/k102336/ 2011-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k102336-radial-jaw-4-pulmonary-standard-fda-510k.jpg K102336 - RADIAL JAW 4 PULMONARY STANDARD CAPACITY BIOPSY FORCEPS K102336 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Boston Scientific Corporation. Cleared Jan 2011. https://www.510kdatabase.net/k102870/ 2011-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k102870-exactech-proliant-polyaxial-pedicle-fda-510k.jpg K102870 - EXACTECH PROLIANT POLYAXIAL PEDICLE SCREW SYSTEM K102870 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Jan 2011. https://www.510kdatabase.net/k103243/ 2011-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k103243-24mm-va-lcp-intercarpal-fusion-system-fda-510k.jpg K103243 - 2.4MM VA-LCP INTERCARPAL FUSION SYSTEM K103243 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jan 2011. https://www.510kdatabase.net/k102814/ 2011-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k102814-elecysys-shbg-fda-510k.jpg K102814 - ELECYSYS SHBG K102814 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Jan 2011. https://www.510kdatabase.net/k102195/ 2011-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k102195-sp-fix-spinous-process-fixation-plate-fda-510k.jpg K102195 - SP-FIX SPINOUS PROCESS FIXATION PLATE K102195 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Jan 2011. https://www.510kdatabase.net/k102370/ 2011-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k102370-r3-xlpe-anteverted-liners-fda-510k.jpg K102370 - R3 XLPE ANTEVERTED LINERS K102370 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jan 2011. https://www.510kdatabase.net/k102589/ 2011-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k102589-codman-bactiseal-catheters-codman-fda-510k.jpg K102589 - CODMAN BACTISEAL CATHETERS, CODMAN BACTISEAL EVD CATHETER K102589 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Jan 2011. https://www.510kdatabase.net/k093678/ 2011-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k093678-platelia-aspergillus-eia-model-62793-fda-510k.jpg K093678 - PLATELIA ASPERGILLUS EIA MODEL 62793 K093678 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bio-Rad. Cleared Jan 2011. https://www.510kdatabase.net/k110030/ 2011-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k110030-expect-endoscopic-aspiration-needle-fda-510k.jpg K110030 - EXPECT ENDOSCOPIC ASPIRATION NEEDLE K110030 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Jan 2011. https://www.510kdatabase.net/k103275/ 2011-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k103275-specialty-coils-for-magnetom-aera-15t-fda-510k.jpg K103275 - SPECIALTY COILS FOR MAGNETOM AERA 1.5T & MAGNETIM SKYRA 3T MR SYSTEMS K103275 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 2011. https://www.510kdatabase.net/k101823/ 2011-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k101823-arthrex-swivelock-anchors-fda-510k.jpg K101823 - ARTHREX SWIVELOCK ANCHORS K101823 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jan 2011. https://www.510kdatabase.net/k102380/ 2011-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k102380-evolution-mp-total-knee-system-fda-510k.jpg K102380 - EVOLUTION MP TOTAL KNEE SYSTEM K102380 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jan 2011. https://www.510kdatabase.net/k103402/ 2011-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k103402-elecsys-dhea-s-calcheck-5-fda-510k.jpg K103402 - ELECSYS DHEA-S CALCHECK 5 K103402 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Jan 2011. https://www.510kdatabase.net/k102293/ 2011-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k102293-caliber-spacer-fda-510k.jpg K102293 - CALIBER SPACER K102293 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Jan 2011. https://www.510kdatabase.net/k103060/ 2011-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k103060-arthrex-tibial-graftbolt-fda-510k.jpg K103060 - ARTHREX TIBIAL GRAFTBOLT K103060 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jan 2011. https://www.510kdatabase.net/k101450/ 2010-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k101450-cantata-microcatheter-fda-510k.jpg K101450 - CANTATA MICROCATHETER K101450 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Dec 2010. https://www.510kdatabase.net/k101837/ 2010-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k101837-acl-tightrope-double-bundle-fda-510k.jpg K101837 - ACL TIGHTROPE DOUBLE BUNDLE K101837 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Dec 2010. https://www.510kdatabase.net/k103359/ 2010-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k103359-finesse-ultra-breast-biopsy-system-fda-510k.jpg K103359 - FINESSE ULTRA BREAST BIOPSY SYSTEM DRIVER (BLUE, PINK) K103359 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 2010. https://www.510kdatabase.net/k103583/ 2010-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k103583-dc-7-diagnostic-ultrasound-system-fda-510k.jpg K103583 - DC-7 DIAGNOSTIC ULTRASOUND SYSTEM K103583 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Dec 2010. https://www.510kdatabase.net/k103049/ 2010-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k103049-tsrh-spinal-system-fda-510k.jpg K103049 - TSRH SPINAL SYSTEM K103049 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Dec 2010. https://www.510kdatabase.net/k103221/ 2010-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k103221-elecys-hgh-calset-elecsys-hgh-calcheck-5-fda-510k.jpg K103221 - ELECYS HGH CALSET, ELECSYS HGH CALCHECK 5 K103221 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Dec 2010. https://www.510kdatabase.net/k102391/ 2010-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k102391-bard-dignishield-stool-management-system-fda-510k.jpg K102391 - BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM K102391 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 2010. https://www.510kdatabase.net/k102392/ 2010-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k102392-microfuse-putty-and-microfuse-st-mis-fda-510k.jpg K102392 - MICROFUSE PUTTY AND MICROFUSE ST MIS K102392 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Dec 2010. https://www.510kdatabase.net/k102502/ 2010-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k102502-golife-nasal-mask-fda-510k.jpg K102502 - GOLIFE NASAL MASK K102502 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Dec 2010. https://www.510kdatabase.net/k102565/ 2010-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k102565-anterior-approach-hip-surgery-fda-510k.jpg K102565 - ANTERIOR APPROACH HIP SURGERY INSTRUMENTS K102565 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Dec 2010. https://www.510kdatabase.net/k102764/ 2010-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k102764-resolution-ii-clip-fda-510k.jpg K102764 - RESOLUTION II CLIP K102764 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Dec 2010. https://www.510kdatabase.net/k102992/ 2010-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k102992-t2-recon-nail-r1500-leftright-125-fda-510k.jpg K102992 - T2 RECON NAIL, R1500, LEFT/RIGHT 125 DEGREES / 120 DEGREES / 130 DEGREES K102992 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Dec 2010. https://www.510kdatabase.net/k103109/ 2010-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k103109-ponsky-non-balloon-replacement-fda-510k.jpg K103109 - PONSKY* NON-BALLOON REPLACEMENT GASTROSTOMY TUBE K103109 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 2010. https://www.510kdatabase.net/k103464/ 2010-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k103464-pacific-xtreme-ptca-balloon-dilatation-fda-510k.jpg K103464 - PACIFIC XTREME PTCA BALLOON DILATATION CATHETER K103464 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Dec 2010. https://www.510kdatabase.net/k103466/ 2010-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k103466-arthrex-univers-ii-shoulder-prosthesis-fda-510k.jpg K103466 - ARTHREX UNIVERS II SHOULDER PROSTHESIS K103466 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Dec 2010. https://www.510kdatabase.net/k100790/ 2010-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k100790-coulter-lin-x-linearity-control-model-fda-510k.jpg K100790 - COULTER LIN-X LINEARITY CONTROL, MODEL A81196 K100790 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Dec 2010. https://www.510kdatabase.net/k093848/ 2010-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k093848-pt-multi-calibrator-model-opat07-fda-510k.jpg K093848 - PT-MULTI-CALIBRATOR, MODEL OPAT07 K093848 is a FDA 510(k) cleared hematology medical device. Manufacturer: Dade Behring, Inc.. Cleared Dec 2010. https://www.510kdatabase.net/k102656/ 2010-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k102656-synthes-dentoalveolar-bone-fixation-fda-510k.jpg K102656 - SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM K102656 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Dec 2010. https://www.510kdatabase.net/k103189/ 2010-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k103189-medacta-total-hip-prosthesis-system-fda-510k.jpg K103189 - MEDACTA TOTAL HIP PROSTHESIS SYSTEM - AMISTEM C & QUADRA C SHORT NECK K103189 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Dec 2010. https://www.510kdatabase.net/k093299/ 2010-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k093299-synthes-orthodontic-bone-anchor-system-fda-510k.jpg K093299 - SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM K093299 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Dec 2010. https://www.510kdatabase.net/k100646/ 2010-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k100646-affinity-pixie-arterial-filter-with-fda-510k.jpg K100646 - AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE K100646 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Dec 2010. https://www.510kdatabase.net/k102766/ 2010-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k102766-composix-lp-mesh-with-echo-ps-fda-510k.jpg K102766 - COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM K102766 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 2010. https://www.510kdatabase.net/k103408/ 2010-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k103408-posterior-lateral-plates-fda-510k.jpg K103408 - POSTERIOR LATERAL PLATES K103408 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Dec 2010. https://www.510kdatabase.net/k100103/ 2010-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k100103-specialty-assayed-control-2-fda-510k.jpg K100103 - SPECIALTY ASSAYED CONTROL-2 K100103 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Dec 2010. https://www.510kdatabase.net/k103374/ 2010-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k103374-inbone-total-ankle-system-model-fda-510k.jpg K103374 - INBONE TOTAL ANKLE SYSTEM MODEL 200347902 K103374 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Dec 2010. https://www.510kdatabase.net/k100779/ 2010-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k100779-sustain-space-maintenance-system-fda-510k.jpg K100779 - SUSTAIN SPACE MAINTENANCE SYSTEM K100779 is a FDA 510(k) cleared dental medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Dec 2010. https://www.510kdatabase.net/k103419/ 2010-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k103419-exactech-equinoxe-r-uhmwpe-posterior-fda-510k.jpg K103419 - EXACTECH EQUINOXE R UHMWPE POSTERIOR AUGMENT PEGGED GLENOIDS TM K103419 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Dec 2010. https://www.510kdatabase.net/k103459/ 2010-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k103459-vascutrak-pta-dilatation-catheter-fda-510k.jpg K103459 - VASCUTRAK PTA DILATATION CATHETER K103459 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 2010. https://www.510kdatabase.net/k101433/ 2010-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k101433-depuy-attune-knee-system-fda-510k.jpg K101433 - DEPUY ATTUNE KNEE SYSTEM K101433 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Dec 2010. https://www.510kdatabase.net/k103008/ 2010-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k103008-inzone-detachment-system-fda-510k.jpg K103008 - INZONE DETACHMENT SYSTEM K103008 is a FDA 510(k) cleared neurology medical device. Manufacturer: Boston Scientific Corp. Cleared Dec 2010. https://www.510kdatabase.net/k102694/ 2010-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k102694-24mm-va-lcp-dorsal-distal-radius-plates-fda-510k.jpg K102694 - 2.4MM VA-LCP DORSAL DISTAL RADIUS PLATES K102694 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Dec 2010. https://www.510kdatabase.net/k101910/ 2010-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k101910-3m-attest-rapid-readout-steam-process-fda-510k.jpg K101910 - 3M ATTEST RAPID READOUT STEAM PROCESS CHALLENGE DEVICE, MODEL 1296V, 3M ATTEST RAPID READOUT STEAM-PLUS K101910 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Dec 2010. https://www.510kdatabase.net/k100709/ 2010-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k100709-ev1000-platform-model-ev1000a-ev1000db-fda-510k.jpg K100709 - EV1000 PLATFORM MODEL: EV1000A, EV1000DB, EV1000M K100709 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Dec 2010. https://www.510kdatabase.net/k100739/ 2010-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k100739-volumeview-system-models-vlv520ft6r-fda-510k.jpg K100739 - VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5 K100739 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Dec 2010. https://www.510kdatabase.net/k103099/ 2010-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k103099-precicontrol-hba1c-norm-fda-510k.jpg K103099 - PRECICONTROL HBA1C NORM K103099 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Dec 2010. https://www.510kdatabase.net/k101229/ 2010-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k101229-longevity-it-highly-crosslinked-fda-510k.jpg K101229 - LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS, CONTINUUM ACETABULAR SYSTEM AND TRILOGY INTEGRATED TAPER K101229 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Dec 2010. https://www.510kdatabase.net/k101730/ 2010-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k101730-longevity-it-highly-crosslinked-fda-510k.jpg K101730 - LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE CONSTRAINED LINERS K101730 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Dec 2010. https://www.510kdatabase.net/k102244/ 2010-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k102244-reliance-endoscope-processing-system-fda-510k.jpg K102244 - RELIANCE ENDOSCOPE PROCESSING SYSTEM K102244 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Dec 2010. https://www.510kdatabase.net/k102313/ 2010-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k102313-patriot-transcontinental-m-spacers-fda-510k.jpg K102313 - PATRIOT TRANSCONTINENTAL M SPACERS K102313 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Dec 2010. https://www.510kdatabase.net/k103314/ 2010-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k103314-clotrac-heparinase-test-cartidge-htc-fda-510k.jpg K103314 - CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL K103314 is a FDA 510(k) cleared hematology medical device. Manufacturer: Medtronic, Inc.. Cleared Dec 2010. https://www.510kdatabase.net/k102352/ 2010-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k102352-evolve-eps-ortholoc-fda-510k.jpg K102352 - EVOLVE EPS ORTHOLOC K102352 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Dec 2010. https://www.510kdatabase.net/k103313/ 2010-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k103313-heparin-assay-controls-fda-510k.jpg K103313 - HEPARIN ASSAY CONTROLS K103313 is a FDA 510(k) cleared hematology medical device. Manufacturer: Medtronic, Inc.. Cleared Dec 2010. https://www.510kdatabase.net/k102429/ 2010-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k102429-ortholoc-3di-ankle-plating-system-fda-510k.jpg K102429 - ORTHOLOC 3DI ANKLE PLATING SYSTEM, ORTHOLOC BONE SCREW K102429 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Nov 2010. https://www.510kdatabase.net/k102122/ 2010-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k102122-smith-nephew-milti-purpose-fda-510k.jpg K102122 - SMITH & NEPHEW MILTI-PURPOSE STERILIZATION TRAY MODEL 72202428 K102122 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Nov 2010. https://www.510kdatabase.net/k102217/ 2010-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k102217-system-1e-chemical-indicator-fda-510k.jpg K102217 - SYSTEM 1E CHEMICAL INDICATOR K102217 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Nov 2010. https://www.510kdatabase.net/k103104/ 2010-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k103104-special-orthopaedic-solutions-glenoid-fda-510k.jpg K103104 - SPECIAL ORTHOPAEDIC SOLUTIONS GLENOID SHOULDER COMPONENT K103104 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Nov 2010. https://www.510kdatabase.net/k092745/ 2010-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k092745-vis-u-all-low-temperature-tyvek-fda-510k.jpg K092745 - VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR ETHYLENE OXIDE, MODELS: SELF AND HEAT SEAL POUCHES, HEAT SEAL TU K092745 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Nov 2010. https://www.510kdatabase.net/k100607/ 2010-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k100607-coulter-4c-ex-300-cell-control-fda-510k.jpg K100607 - COULTER 4C-EX 300 CELL CONTROL K100607 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Nov 2010. https://www.510kdatabase.net/k103162/ 2010-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k103162-elecsys-pth-calcheck-5-fda-510k.jpg K103162 - ELECSYS PTH CALCHECK 5 K103162 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Nov 2010. https://www.510kdatabase.net/k102159/ 2010-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k102159-powerpicc-sv-catheters-fda-510k.jpg K102159 - POWERPICC SV CATHETERS K102159 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 2010. https://www.510kdatabase.net/k102555/ 2010-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k102555-cd-horizon-spinal-system-fda-510k.jpg K102555 - CD HORIZON SPINAL SYSTEM K102555 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Nov 2010. https://www.510kdatabase.net/k093054/ 2010-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k093054-scalp-dura-retractor-model-ks00474-fda-510k.jpg K093054 - SCALP DURA RETRACTOR, MODEL KS00474 K093054 is a FDA 510(k) cleared neurology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Nov 2010. https://www.510kdatabase.net/k103012/ 2010-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k103012-exactech-bioloxdelta-biolox-femoral-fda-510k.jpg K103012 - EXACTECH BIOLOXDELTA / BIOLOX FEMORAL HEADS, 28MM OD, 32MM OD, 36MM OD, EXACTECH BIOLOX OPTION ADAPTERS/FEMORAL HEADS K103012 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Nov 2010. https://www.510kdatabase.net/k103003/ 2010-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k103003-aesculap-meithke-progav-programmable-fda-510k.jpg K103003 - AESCULAP- MEITHKE PROGAV PROGRAMMABLE SHUNT SYSTEM K103003 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Nov 2010. https://www.510kdatabase.net/k102487/ 2010-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k102487-novation-femoral-stem-tapered-1214-fda-510k.jpg K102487 - NOVATION FEMORAL STEM, TAPERED 12/14 , STANDARD/EXTENDED OFFSET, PLASMA COATED, PRESS-FIT, SIZE 19/20 K102487 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Nov 2010. https://www.510kdatabase.net/k102527/ 2010-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k102527-imager-ii-urology-torque-catheter-c1-tip-fda-510k.jpg K102527 - IMAGER II UROLOGY TORQUE CATHETER (C1 TIP) K102527 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Nov 2010. https://www.510kdatabase.net/k102975/ 2010-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k102975-novation-crown-cup-with-integrip-fda-510k.jpg K102975 - NOVATION CROWN CUP WITH INTEGRIP ACETABULAR SHELL, CLUSTER-HOLE K102975 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Nov 2010. https://www.510kdatabase.net/k102951/ 2010-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k102951-exactech-equinox-fixed-angle-fda-510k.jpg K102951 - EXACTECH EQUINOX FIXED ANGLE REPLICATOR PLATE (0MM,1.5MM,4.5MM), HUMERAL HEAD-SHORT (44MM,47MM), GLENOSPHERE (38MM,42MM) K102951 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Nov 2010. https://www.510kdatabase.net/k102953/ 2010-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k102953-heparin-dose-response-cartridge-fda-510k.jpg K102953 - HEPARIN DOSE RESPONSE CARTRIDGE K102953 is a FDA 510(k) cleared hematology medical device. Manufacturer: Medtronic, Inc.. Cleared Nov 2010. https://www.510kdatabase.net/k101882/ 2010-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k101882-prontosan-antimicrobial-wound-gel-fda-510k.jpg K101882 - PRONTOSAN ANTIMICROBIAL WOUND GEL K101882 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Nov 2010. https://www.510kdatabase.net/k102865/ 2010-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k102865-dc-7-diagnostic-ultrasound-system-dc-fda-510k.jpg K102865 - DC-7 DIAGNOSTIC ULTRASOUND SYSTEM, DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM K102865 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Nov 2010. https://www.510kdatabase.net/k102086/ 2010-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k102086-elecsys-ca-125-ii-calcheck-5-fda-510k.jpg K102086 - ELECSYS CA 125 II CALCHECK 5 K102086 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics. Cleared Nov 2010. https://www.510kdatabase.net/k100589/ 2010-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k100589-mrsa-select-skin-and-soft-tissue-wound-fda-510k.jpg K100589 - MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS K100589 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bio-Rad. Cleared Oct 2010. https://www.510kdatabase.net/k102423/ 2010-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k102423-depuy-pinnacle-altrx-acetabular-liners-fda-510k.jpg K102423 - DEPUY PINNACLE ALTRX ACETABULAR LINERS K102423 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Oct 2010. https://www.510kdatabase.net/k102420/ 2010-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k102420-embol-x-access-device-aortic-cannula-fda-510k.jpg K102420 - EMBOL-X ACCESS DEVICE/ AORTIC CANNULA, EMBOL-X SLIM ACCESSDEVICE/ AORTIC CANNULA, EMBOL-X GLIDE ACCESS DEVICE/ AORTIC CA K102420 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Oct 2010. https://www.510kdatabase.net/k102523/ 2010-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k102523-multi-lead-trialing-cable-model-355531-fda-510k.jpg K102523 - MULTI-LEAD TRIALING CABLE MODEL 355531 K102523 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic, Inc.. Cleared Oct 2010. https://www.510kdatabase.net/k093293/ 2010-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k093293-vanguard-360-revision-knee-system-fda-510k.jpg K093293 - VANGUARD 360 REVISION KNEE SYSTEM K093293 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Oct 2010. https://www.510kdatabase.net/k101679/ 2010-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k101679-arthrex-pushlock-anchors-fda-510k.jpg K101679 - ARTHREX PUSHLOCK ANCHORS K101679 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Oct 2010. https://www.510kdatabase.net/k102991/ 2010-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k102991-m5-diagnostic-ultrasound-system-fda-510k.jpg K102991 - M5 DIAGNOSTIC ULTRASOUND SYSTEM K102991 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Oct 2010. https://www.510kdatabase.net/k093076/ 2010-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k093076-vitek-2-gram-positive-doxcycline-fda-510k.jpg K093076 - VITEK 2 GRAM POSITIVE DOXCYCLINE K093076 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Oct 2010. https://www.510kdatabase.net/k100976/ 2010-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k100976-t2-xvbr-15-spinal-system-fda-510k.jpg K100976 - T2 XVBR 1.5 SPINAL SYSTEM K100976 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Oct 2010. https://www.510kdatabase.net/k102426/ 2010-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k102426-carescape-model-v100-vital-signs-monitor-fda-510k.jpg K102426 - CARESCAPE MODEL V100 VITAL SIGNS MONITOR K102426 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Oct 2010. https://www.510kdatabase.net/k093471/ 2010-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k093471-karl-storz-arthropump-power-fda-510k.jpg K093471 - KARL STORZ ARTHROPUMP POWER IRRIGATION/SUCTION PUMP K093471 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Oct 2010. https://www.510kdatabase.net/k102672/ 2010-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k102672-target-detachable-coil-fda-510k.jpg K102672 - TARGET DETACHABLE COIL K102672 is a FDA 510(k) cleared neurology medical device. Manufacturer: Boston Scientific Corp. Cleared Oct 2010. https://www.510kdatabase.net/k094060/ 2010-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k094060-quanta-flash-h-ttg-iga-fda-510k.jpg K094060 - QUANTA FLASH H-TTG IGA K094060 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Oct 2010. https://www.510kdatabase.net/k101271/ 2010-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k101271-hemostasis-management-system-plus-hms-fda-510k.jpg K101271 - HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX K101271 is a FDA 510(k) cleared hematology medical device. Manufacturer: Medtronic, Inc.. Cleared Oct 2010. https://www.510kdatabase.net/k102671/ 2010-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k102671-syngo-rt-therapist-connect-workspace-v42-fda-510k.jpg K102671 - SYNGO RT THERAPIST CONNECT WORKSPACE, V4.2 K102671 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 2010. https://www.510kdatabase.net/k101166/ 2010-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k101166-4d-view-91-4d-view-pc-software-model-fda-510k.jpg K101166 - 4D-VIEW 9.1 (4D VIEW PC SOFTWARE) MODEL: H48651SZ K101166 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Oct 2010. https://www.510kdatabase.net/k102269/ 2010-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k102269-elecsys-ige-calcheck-5-fda-510k.jpg K102269 - ELECSYS IGE CALCHECK 5 K102269 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics. Cleared Oct 2010. https://www.510kdatabase.net/k101365/ 2010-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k101365-elecsys-ca-19-9-calcheck-5-fda-510k.jpg K101365 - ELECSYS CA 19-9 CALCHECK 5 K101365 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Oct 2010. https://www.510kdatabase.net/k101657/ 2010-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k101657-radial-4-hot-biopsy-forceps-box-5-fda-510k.jpg K101657 - RADIAL 4 HOT BIOPSY FORCEPS BOX 5 K101657 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Oct 2010. https://www.510kdatabase.net/k101856/ 2010-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k101856-elecsys-cea-calcheck-5-fda-510k.jpg K101856 - ELECSYS CEA CALCHECK 5 K101856 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics. Cleared Oct 2010. https://www.510kdatabase.net/k101874/ 2010-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k101874-ge-logiq-p6p6-pro-fda-510k.jpg K101874 - GE LOGIQ P6/P6 PRO K101874 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Oct 2010. https://www.510kdatabase.net/k102069/ 2010-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k102069-journey-unicondylar-tibial-baseplates-fda-510k.jpg K102069 - JOURNEY UNICONDYLAR TIBIAL BASEPLATES K102069 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 2010. https://www.510kdatabase.net/k102150/ 2010-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k102150-syngo-dynamics-version-90-fda-510k.jpg K102150 - SYNGO DYNAMICS, VERSION 9.0 K102150 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 2010. https://www.510kdatabase.net/k101347/ 2010-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k101347-magnetom-aera-fda-510k.jpg K101347 - MAGNETOM AERA K101347 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 2010. https://www.510kdatabase.net/k101528/ 2010-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k101528-3m-comply-lead-free-process-indicators-fda-510k.jpg K101528 - 3M COMPLY LEAD FREE PROCESS INDICATORS FOR STEAM K101528 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Oct 2010. https://www.510kdatabase.net/k101622/ 2010-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k101622-zimmer-natural-nail-system-retrograde-fda-510k.jpg K101622 - ZIMMER NATURAL NAIL SYSTEM RETROGRADE FEMORAL NAILS K101622 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Oct 2010. https://www.510kdatabase.net/k101772/ 2010-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k101772-tsrhr-spinal-system-fda-510k.jpg K101772 - TSRH(R) SPINAL SYSTEM K101772 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Sep 2010. https://www.510kdatabase.net/k100114/ 2010-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k100114-fat-concentration-system-fda-510k.jpg K100114 - FAT CONCENTRATION SYSTEM K100114 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Biomet, Inc.. Cleared Sep 2010. https://www.510kdatabase.net/k100391/ 2010-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k100391-depuy-universal-gription-tf-cones-fda-510k.jpg K100391 - DEPUY UNIVERSAL GRIPTION TF CONES K100391 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Sep 2010. https://www.510kdatabase.net/k101566/ 2010-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k101566-vitek-2-yeast-caspofungin-fda-510k.jpg K101566 - VITEK 2 YEAST CASPOFUNGIN K101566 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Sep 2010. https://www.510kdatabase.net/k091445/ 2010-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k091445-cd-horizon-spinal-system-fda-510k.jpg K091445 - CD HORIZON SPINAL SYSTEM K091445 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Sep 2010. https://www.510kdatabase.net/k093047/ 2010-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k093047-smith-nephew-circular-fixation-system-fda-510k.jpg K093047 - SMITH & NEPHEW CIRCULAR FIXATION SYSTEM K093047 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Sep 2010. https://www.510kdatabase.net/k102437/ 2010-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k102437-gmk-revision-knee-system-fda-510k.jpg K102437 - GMK REVISION KNEE SYSTEM K102437 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Sep 2010. https://www.510kdatabase.net/k101761/ 2010-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k101761-exactech-novation-empire-acetabular-fda-510k.jpg K101761 - EXACTECH NOVATION EMPIRE ACETABULAR AUGMENT WITH INTEGRIP MODEL 186-01-08/11/13, 186-02-08/11/13, 186-03-08/11/13 K101761 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Sep 2010. https://www.510kdatabase.net/k102462/ 2010-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k102462-system-1e-liquid-chemical-sterilant-fda-510k.jpg K102462 - SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM K102462 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Sep 2010. https://www.510kdatabase.net/k102017/ 2010-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k102017-sc2000-diagnostic-ultrasound-system-fda-510k.jpg K102017 - SC2000 DIAGNOSTIC ULTRASOUND SYSTEM K102017 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 2010. https://www.510kdatabase.net/k100787/ 2010-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k100787-renasys-f-ab-abdominal-wound-dressing-fda-510k.jpg K100787 - RENASYS F/-AB ABDOMINAL WOUND DRESSING KIT K100787 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Sep 2010. https://www.510kdatabase.net/k101129/ 2010-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k101129-esprit-ventilator-with-af531-se-full-fda-510k.jpg K101129 - ESPRIT VENTILATOR WITH AF531 SE FULL FACE MASK K101129 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Sep 2010. https://www.510kdatabase.net/k101203/ 2010-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k101203-tina-quant-albumin-gen-2-fda-510k.jpg K101203 - TINA-QUANT ALBUMIN GEN 2 K101203 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Sep 2010. https://www.510kdatabase.net/k101696/ 2010-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k101696-motionloc-screw-for-ncb-polyaxial-fda-510k.jpg K101696 - MOTIONLOC SCREW FOR NCB POLYAXIAL LOCKING PLATING SYSTEM K101696 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Sep 2010. https://www.510kdatabase.net/k102267/ 2010-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k102267-elecsys-ferritin-calcheck-5-fda-510k.jpg K102267 - ELECSYS FERRITIN CALCHECK 5 K102267 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Sep 2010. https://www.510kdatabase.net/k100853/ 2010-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k100853-cobas-8000-modular-series-analyzer-fda-510k.jpg K100853 - COBAS 8000 MODULAR SERIES ANALYZER K100853 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Sep 2010. https://www.510kdatabase.net/k101885/ 2010-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k101885-medtronic-c315-delivery-catheter-fda-510k.jpg K101885 - MEDTRONIC C315 DELIVERY CATHETER K101885 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Sep 2010. https://www.510kdatabase.net/k101249/ 2010-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k101249-sterigage-model-1243ra-1243rb-1243re-fda-510k.jpg K101249 - STERIGAGE MODEL 1243RA, 1243RB, 1243RE K101249 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Sep 2010. https://www.510kdatabase.net/k101456/ 2010-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k101456-roche-diagnostics-calibrator-for-fda-510k.jpg K101456 - ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATOR CALIBRATOR FOR AUTOMATED SYSTEM K101456 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Sep 2010. https://www.510kdatabase.net/k101868/ 2010-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k101868-infinix-i-interventional-angiography-fda-510k.jpg K101868 - INFINIX-I INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V K101868 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Sep 2010. https://www.510kdatabase.net/k102273/ 2010-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k102273-merit-bipolar-coagulation-probe-fda-510k.jpg K102273 - MERIT BIPOLAR COAGULATION PROBE K102273 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Sep 2010. https://www.510kdatabase.net/k101086/ 2010-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k101086-taperloc-complete-fda-510k.jpg K101086 - TAPERLOC COMPLETE K101086 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Sep 2010. https://www.510kdatabase.net/k101550/ 2010-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k101550-biograph-mct-family-fda-510k.jpg K101550 - BIOGRAPH MCT FAMILY K101550 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 2010. https://www.510kdatabase.net/k101834/ 2010-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k101834-3m-littmann-scope-to-scope-software-fda-510k.jpg K101834 - 3M LITTMANN SCOPE-TO SCOPE SOFTWARE SYSTEM K101834 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: 3M Company. Cleared Sep 2010. https://www.510kdatabase.net/k102011/ 2010-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k102011-eclipse-treatment-planning-system-fda-510k.jpg K102011 - ECLIPSE TREATMENT PLANNING SYSTEM K102011 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Sep 2010. https://www.510kdatabase.net/k093430/ 2010-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k093430-exactech-equinoxe-xl-keeled-glenoid-fda-510k.jpg K093430 - EXACTECH EQUINOXE XL KEELED GLENOID, PEGGED GLENOID, EXACTECH EQUINOXE CAGE, GLENOID CONTD. K093430 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Sep 2010. https://www.510kdatabase.net/k100795/ 2010-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k100795-jet-x-bar-system-clamps-and-posts-fda-510k.jpg K100795 - JET-X BAR SYSTEM CLAMPS AND POSTS REPROCESSING K100795 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Sep 2010. https://www.510kdatabase.net/k101130/ 2010-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k101130-bipap-synchrony-2-with-af531-full-face-fda-510k.jpg K101130 - BIPAP SYNCHRONY 2 WITH AF531 FULL FACE MASK K101130 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Sep 2010. https://www.510kdatabase.net/k102016/ 2010-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k102016-precicontrol-clinchem-multi-1-and-2-fda-510k.jpg K102016 - PRECICONTROL CLINCHEM MULTI 1 AND 2 K102016 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Sep 2010. https://www.510kdatabase.net/k101339/ 2010-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k101339-archer-super-stiff-guidewires-fda-510k.jpg K101339 - ARCHER SUPER STIFF GUIDEWIRES K101339 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Aug 2010. https://www.510kdatabase.net/k101878/ 2010-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k101878-ge-logiq-p5-model-h44662ld-fda-510k.jpg K101878 - GE LOGIQ P5 MODEL H44662LD K101878 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Aug 2010. https://www.510kdatabase.net/k102044/ 2010-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k102044-elecsys-digoxin-calcheck-5-fda-510k.jpg K102044 - ELECSYS DIGOXIN CALCHECK 5 K102044 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Aug 2010. https://www.510kdatabase.net/k092449/ 2010-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k092449-beneview-t-series-patient-monitors-fda-510k.jpg K092449 - BENEVIEW T SERIES PATIENT MONITORS, MODELS BENEVIEW T8, T6 AND T5 K092449 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Aug 2010. https://www.510kdatabase.net/k100141/ 2010-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k100141-14-channel-extremity-coil-for-magnetom-fda-510k.jpg K100141 - 14-CHANNEL EXTREMITY COIL FOR MAGNETOM ESSENZA K100141 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 2010. https://www.510kdatabase.net/k101196/ 2010-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k101196-accu-chek-ultrflex-infusion-set-fda-510k.jpg K101196 - ACCU-CHEK ULTRFLEX INFUSION SET K101196 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Aug 2010. https://www.510kdatabase.net/k102157/ 2010-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k102157-elecsys-precicontrol-multimarker-fda-510k.jpg K102157 - ELECSYS PRECICONTROL MULTIMARKER K102157 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Aug 2010. https://www.510kdatabase.net/k100886/ 2010-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k100886-inbone-ii-total-ankle-replacement-fda-510k.jpg K100886 - INBONE II TOTAL ANKLE REPLACEMENT K100886 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Aug 2010. https://www.510kdatabase.net/k101499/ 2010-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k101499-journey-cr-knee-system-fda-510k.jpg K101499 - JOURNEY CR KNEE SYSTEM K101499 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Aug 2010. https://www.510kdatabase.net/k101728/ 2010-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k101728-focus-tm-echogenic-nerve-stimulating-fda-510k.jpg K101728 - FOCUS (TM) ECHOGENIC NERVE STIMULATING NEEDLE K101728 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Cook, Inc.. Cleared Aug 2010. https://www.510kdatabase.net/k101168/ 2010-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k101168-legend-power-adapter-model-6475000-fda-510k.jpg K101168 - LEGEND POWER ADAPTER MODEL: 6475000 K101168 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Aug 2010. https://www.510kdatabase.net/k102082/ 2010-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k102082-extractor-pro-rx-retrieval-ballons-fda-510k.jpg K102082 - EXTRACTOR PRO RX RETRIEVAL BALLONS, EXTRACTOR PRO XL RETRIEVAL BALLONS, EXTRACTOR PRO DL RETRIEVAL BALLONS MODEL M005470 K102082 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Aug 2010. https://www.510kdatabase.net/k092767/ 2010-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k092767-bbl-chromagar-mrsa-ii-fda-510k.jpg K092767 - BBL CHROMAGAR MRSA II K092767 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Aug 2010. https://www.510kdatabase.net/k091692/ 2010-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k091692-aesculap-peek-craniofix-fda-510k.jpg K091692 - AESCULAP PEEK CRANIOFIX K091692 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Aug 2010. https://www.510kdatabase.net/k093828/ 2010-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k093828-kyph-x-hv-r-bone-cement-fda-510k.jpg K093828 - KYPH X HV-R BONE CEMENT K093828 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic, Inc.. Cleared Aug 2010. https://www.510kdatabase.net/k101937/ 2010-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k101937-hybrid-trocar-system-fda-510k.jpg K101937 - HYBRID TROCAR SYSTEM K101937 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Aug 2010. https://www.510kdatabase.net/k100973/ 2010-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k100973-evolution-unicondylar-knee-system-fda-510k.jpg K100973 - EVOLUTION UNICONDYLAR KNEE SYSTEM K100973 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Aug 2010. https://www.510kdatabase.net/k101212/ 2010-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k101212-medtronic-contour-3d-annuloplasty-ring-fda-510k.jpg K101212 - MEDTRONIC CONTOUR 3D ANNULOPLASTY RING, MODEL 690R K101212 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Aug 2010. https://www.510kdatabase.net/k101877/ 2010-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k101877-occlusion-balloon-catheter-model-obc-fda-510k.jpg K101877 - OCCLUSION BALLOON CATHETER MODEL OBC K101877 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Aug 2010. https://www.510kdatabase.net/k102001/ 2010-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k102001-modification-to-renasys-ez-plus-fda-510k.jpg K102001 - MODIFICATION TO RENASYS EZ PLUS NEGATIVE PRESSURE WOUND THERAPY K102001 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Aug 2010. https://www.510kdatabase.net/k102081/ 2010-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k102081-endoscopic-clip-system-fda-510k.jpg K102081 - ENDOSCOPIC CLIP SYSTEM K102081 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Aug 2010. https://www.510kdatabase.net/k100776/ 2010-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k100776-synthes-24-mm27-mm-variable-angle-lcp-fda-510k.jpg K100776 - SYNTHES 2.4 MM/2.7 MM VARIABLE ANGLE LCP FOREFOOT/MIDFOOT SYSTEM K100776 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Aug 2010. https://www.510kdatabase.net/k101409/ 2010-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k101409-system-ie-liquid-chemical-cterilant-fda-510k.jpg K101409 - SYSTEM IE LIQUID CHEMICAL CTERILANT PROCESSING SYSTEM K101409 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Aug 2010. https://www.510kdatabase.net/k101909/ 2010-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k101909-exactech-equinoxe-platform-fracture-stem-fda-510k.jpg K101909 - EXACTECH EQUINOXE, PLATFORM FRACTURE STEM K101909 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Aug 2010. https://www.510kdatabase.net/k101981/ 2010-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k101981-optetrak-logic-combination-tibial-tray-fda-510k.jpg K101981 - OPTETRAK LOGIC COMBINATION TIBIAL TRAY K101981 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Aug 2010. https://www.510kdatabase.net/k091018/ 2010-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k091018-arthrex-biowire-fda-510k.jpg K091018 - ARTHREX BIOWIRE K091018 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Arthrex, Inc.. Cleared Jul 2010. https://www.510kdatabase.net/k101296/ 2010-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k101296-zimmer-segmental-system-proximal-fda-510k.jpg K101296 - ZIMMER SEGMENTAL SYSTEM PROXIMAL FEMORAL COMPONENT AND SMALL DIAMETER STEM EXTENSIONS K101296 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jul 2010. https://www.510kdatabase.net/k101261/ 2010-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k101261-catheter-repair-kit-with-replacement-fda-510k.jpg K101261 - CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 K101261 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jul 2010. https://www.510kdatabase.net/k093664/ 2010-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k093664-amphetamines-ii-assay-fda-510k.jpg K093664 - AMPHETAMINES II ASSAY K093664 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jul 2010. https://www.510kdatabase.net/k093493/ 2010-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k093493-aesculap-sterilcontainer-s-fda-510k.jpg K093493 - AESCULAP STERILCONTAINER S K093493 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Aesculap, Inc.. Cleared Jul 2010. https://www.510kdatabase.net/k101165/ 2010-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k101165-pro-toe-vo-hammertow-implant-system-fda-510k.jpg K101165 - PRO-TOE VO HAMMERTOW IMPLANT SYSTEM K101165 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jul 2010. https://www.510kdatabase.net/k101240/ 2010-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k101240-closed-fusion-plate-mtp-plate-talus-fda-510k.jpg K101240 - CLOSED FUSION PLATE, MTP PLATE, TALUS PLATE, MODEL 824077021, 22 K101240 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jul 2010. https://www.510kdatabase.net/k101314/ 2010-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k101314-advanix-biliary-stent-with-naviflex-rx-fda-510k.jpg K101314 - ADVANIX BILIARY STENT WITH NAVIFLEX RX DELIVERY SYSTEM K101314 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Jul 2010. https://www.510kdatabase.net/k101777/ 2010-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k101777-pioneer-plus-catheter-model-plus-120-fda-510k.jpg K101777 - PIONEER PLUS CATHETER, MODEL PLUS 120 K101777 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jul 2010. https://www.510kdatabase.net/k101786/ 2010-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k101786-advanix-double-pigtail-biliary-stent-fda-510k.jpg K101786 - ADVANIX DOUBLE PIGTAIL BILIARY STENT K101786 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Jul 2010. https://www.510kdatabase.net/k100640/ 2010-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k100640-20-mmvial-fluid-transfer-adapter-model-fda-510k.jpg K100640 - 20 MMVIAL FLUID TRANSFER ADAPTER, MODEL 7E2500 K100640 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Jul 2010. https://www.510kdatabase.net/k102008/ 2010-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k102008-glidesheath-fda-510k.jpg K102008 - GLIDESHEATH K102008 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Jul 2010. https://www.510kdatabase.net/k093784/ 2010-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k093784-athena-multi-lyte-torch-igg-plus-test-fda-510k.jpg K093784 - ATHENA MULTI-LYTE TORCH IGG PLUS TEST SYSTEM K093784 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Jul 2010. https://www.510kdatabase.net/k100481/ 2010-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k100481-smith-nephew-mdf-modular-sleeve-fda-510k.jpg K100481 - SMITH & NEPHEW MDF MODULAR SLEEVE K100481 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 2010. https://www.510kdatabase.net/k100038/ 2010-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k100038-disposable-reflective-marker-spheres-fda-510k.jpg K100038 - DISPOSABLE REFLECTIVE MARKER SPHERES K100038 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Jul 2010. https://www.510kdatabase.net/k100876/ 2010-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k100876-aesculap-monomax-absorbable-suture-fda-510k.jpg K100876 - AESCULAP MONOMAX ABSORBABLE SUTURE K100876 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Jul 2010. https://www.510kdatabase.net/k093967/ 2010-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k093967-varian-treatment-fda-510k.jpg K093967 - VARIAN TREATMENT K093967 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Jul 2010. https://www.510kdatabase.net/k092573/ 2010-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k092573-nihon-kohden-qp-160ak-eeg-trend-program-fda-510k.jpg K092573 - NIHON KOHDEN QP-160AK EEG TREND PROGRAM K092573 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Jul 2010. https://www.510kdatabase.net/k101514/ 2010-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k101514-bd-directigen-ez-rsv-fda-510k.jpg K101514 - BD DIRECTIGEN EZ RSV K101514 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Jul 2010. https://www.510kdatabase.net/k101651/ 2010-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k101651-angioguard-xp-emboli-capture-guidewire-fda-510k.jpg K101651 - ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE, ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE K101651 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Jul 2010. https://www.510kdatabase.net/k093383/ 2010-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k093383-nuclisens-easyq-enterovirus-v11-fda-510k.jpg K093383 - NUCLISENS EASYQ ENTEROVIRUS V1.1., NUCLISENS EASYQ DIRECTOR 2.6, NUCLISENS EASYQ ANALYZER, NUCLISENS MINIMAG K093383 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jul 2010. https://www.510kdatabase.net/k100728/ 2010-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k100728-athena-multi-lyte-borrelia-vlse-fda-510k.jpg K100728 - ATHENA MULTI-LYTE BORRELIA VLSE-1/PEPC10 PLUS TEST SYSTEM K100728 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Jul 2010. https://www.510kdatabase.net/k100302/ 2010-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k100302-medline-pvc-urethral-catheter-fda-510k.jpg K100302 - MEDLINE PVC URETHRAL CATHETER K100302 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medline Industries, Inc.. Cleared Jul 2010. https://www.510kdatabase.net/k093877/ 2010-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k093877-retroflex-3-introducer-sheath-set-fda-510k.jpg K093877 - RETROFLEX 3 INTRODUCER SHEATH SET, MODELS 9120S23 AND 9120S26 K093877 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Jul 2010. https://www.510kdatabase.net/k100634/ 2010-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k100634-synthes-matrix-system-fda-510k.jpg K100634 - SYNTHES MATRIX SYSTEM K100634 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jul 2010. https://www.510kdatabase.net/k100936/ 2010-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k100936-gynecare-tvt-abbrevo-continence-system-fda-510k.jpg K100936 - GYNECARE TVT ABBREVO CONTINENCE SYSTEM K100936 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ethicon, Inc.. Cleared Jul 2010. https://www.510kdatabase.net/k094042/ 2010-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k094042-peek-prevail-cervical-interbody-device-fda-510k.jpg K094042 - PEEK PREVAIL CERVICAL INTERBODY DEVICE K094042 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Jun 2010. https://www.510kdatabase.net/k101491/ 2010-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k101491-uroskop-omnia-fda-510k.jpg K101491 - UROSKOP OMNIA K101491 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 2010. https://www.510kdatabase.net/k101502/ 2010-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k101502-bd-vacutainer-rapid-serum-tube-blood-fda-510k.jpg K101502 - BD VACUTAINER RAPID SERUM TUBE BLOOD COLLECTION TUBE, MODEL 368774 K101502 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Becton, Dickinson & CO. Cleared Jun 2010. https://www.510kdatabase.net/k100214/ 2010-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k100214-cornerstone-psr-cervical-interbody-fda-510k.jpg K100214 - CORNERSTONE PSR CERVICAL INTERBODY FUSION DEVICE K100214 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Jun 2010. https://www.510kdatabase.net/k100884/ 2010-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k100884-stryker-knifelight-fda-510k.jpg K100884 - STRYKER KNIFELIGHT K100884 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jun 2010. https://www.510kdatabase.net/k101431/ 2010-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k101431-eclipse-filter-system-femoral-and-fda-510k.jpg K101431 - ECLIPSE FILTER SYSTEM-FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS K101431 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jun 2010. https://www.510kdatabase.net/k100359/ 2010-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k100359-darco-headed-cannulated-screw-fda-510k.jpg K100359 - DARCO HEADED CANNULATED SCREW K100359 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jun 2010. https://www.510kdatabase.net/k100652/ 2010-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k100652-acl-tightrope-fda-510k.jpg K100652 - ACL TIGHTROPE K100652 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jun 2010. https://www.510kdatabase.net/k093955/ 2010-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k093955-anti-hav-igm-fda-510k.jpg K093955 - ANTI-HAV IGM K093955 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Diagnostics. Cleared Jun 2010. https://www.510kdatabase.net/k100538/ 2010-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k100538-tina-quant-ferritin-gen-4-fda-510k.jpg K100538 - TINA-QUANT FERRITIN GEN. 4 K100538 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics. Cleared Jun 2010. https://www.510kdatabase.net/k100631/ 2010-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k100631-affiity-cp-centrifugal-blood-pump-fda-510k.jpg K100631 - AFFIITY CP CENTRIFUGAL BLOOD PUMP K100631 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Jun 2010. https://www.510kdatabase.net/k101074/ 2010-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k101074-modification-to-cd-horizonr-spinal-fda-510k.jpg K101074 - MODIFICATION TO: CD HORIZON(R) SPINAL SYSTEM K101074 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Jun 2010. https://www.510kdatabase.net/k101385/ 2010-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k101385-dual-luer-lock-cap-model-2c6250-fda-510k.jpg K101385 - DUAL LUER LOCK CAP, MODEL 2C6250 K101385 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jun 2010. https://www.510kdatabase.net/k093623/ 2010-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k093623-gem-premier-4000-with-iqm-addition-of-fda-510k.jpg K093623 - GEM PREMIER 4000 WITH IQM (ADDITION OF TOTAL BILIRUBIN PARAMETER), GEM CVP 2 (ADDITION OF TOTAL BILIRUBIM ASSIGNMENT TO K093623 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jun 2010. https://www.510kdatabase.net/k101438/ 2010-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k101438-t2-greater-trochanter-nail-fda-510k.jpg K101438 - T2 GREATER TROCHANTER NAIL K101438 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jun 2010. https://www.510kdatabase.net/k101119/ 2010-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k101119-syngo-dosimetrist-workspace-v27-model-fda-510k.jpg K101119 - SYNGO DOSIMETRIST WORKSPACE V2.7 MODEL: 1056864 K101119 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 2010. https://www.510kdatabase.net/k101421/ 2010-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k101421-medical-plates-lateral-plates-fda-510k.jpg K101421 - MEDICAL PLATES, LATERAL PLATES, POSTERIOR LATERAL PLATES, OLECRANON PLATES MODEL 131218704-708 K101421 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jun 2010. https://www.510kdatabase.net/k101529/ 2010-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k101529-bd-directigen-ez-flu-ab-assay-fda-510k.jpg K101529 - BD DIRECTIGEN EZ FLU A+B ASSAY K101529 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Jun 2010. https://www.510kdatabase.net/k093118/ 2010-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k093118-brainlab-knee-arthroscopy-fda-510k.jpg K093118 - BRAINLAB KNEE ARTHROSCOPY K093118 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Brainlab AG. Cleared Jun 2010. https://www.510kdatabase.net/k100630/ 2010-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k100630-g-force-peek-suture-anchor-system-fda-510k.jpg K100630 - G-FORCE PEEK SUTURE ANCHOR SYSTEM K100630 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jun 2010. https://www.510kdatabase.net/k101075/ 2010-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k101075-elecsys-insulin-calcheck-5-fda-510k.jpg K101075 - ELECSYS INSULIN CALCHECK 5 K101075 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jun 2010. https://www.510kdatabase.net/k100137/ 2010-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k100137-sidekick-circular-fixator-system-fda-510k.jpg K100137 - SIDEKICK CIRCULAR FIXATOR SYSTEM: STRUTS AND HINGES K100137 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jun 2010. https://www.510kdatabase.net/k100175/ 2010-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k100175-clydesdale-spinal-system-fda-510k.jpg K100175 - CLYDESDALE SPINAL SYSTEM K100175 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Jun 2010. https://www.510kdatabase.net/k093275/ 2010-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k093275-exactech-equinoxe-reverse-shoulder-fda-510k.jpg K093275 - EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM 36MM GLENOSPHERE AND HUMERAL LINER K093275 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared May 2010. https://www.510kdatabase.net/k100269/ 2010-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k100269-novation-crown-cup-gxl-liners-fda-510k.jpg K100269 - NOVATION CROWN CUP GXL LINERS K100269 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared May 2010. https://www.510kdatabase.net/k093973/ 2010-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k093973-trufill-dcs-orbit-detachable-coil-system-fda-510k.jpg K093973 - TRUFILL DCS ORBIT DETACHABLE COIL SYSTEM K093973 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared May 2010. https://www.510kdatabase.net/k093405/ 2010-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k093405-prophecy-pre-operative-navigation-fda-510k.jpg K093405 - PROPHECY PRE-OPERATIVE NAVIGATION ALIGNMENT GUIDES K093405 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared May 2010. https://www.510kdatabase.net/k091556/ 2010-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k091556-hemosil-acustar-anti-b2-glycoprotein-i-fda-510k.jpg K091556 - HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I K091556 is a FDA 510(k) cleared immunology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared May 2010. https://www.510kdatabase.net/k092454/ 2010-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k092454-vitek-2-yeast-voriconazole-fda-510k.jpg K092454 - VITEK 2 YEAST VORICONAZOLE K092454 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared May 2010. https://www.510kdatabase.net/k101139/ 2010-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k101139-prostiva-rf-therapy-model-8929-hand-fda-510k.jpg K101139 - PROSTIVA RF THERAPY MODEL 8929 HAND PIECE K101139 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medtronic, Inc.. Cleared May 2010. https://www.510kdatabase.net/k100010/ 2010-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k100010-hdl-cholesterol-hdlx-assay-fda-510k.jpg K100010 - HDL CHOLESTEROL (HDLX) ASSAY K100010 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared May 2010. https://www.510kdatabase.net/k100271/ 2010-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k100271-vari-ax-distal-radius-line-extensions-fda-510k.jpg K100271 - VARI AX DISTAL RADIUS LINE EXTENSIONS OF XXL PLATES K100271 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared May 2010. https://www.510kdatabase.net/k100788/ 2010-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k100788-cocr-rods-fda-510k.jpg K100788 - COCR RODS K100788 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared May 2010. https://www.510kdatabase.net/k100897/ 2010-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k100897-legion-porous-ha-tibial-baseplates-fda-510k.jpg K100897 - LEGION POROUS + HA TIBIAL BASEPLATES K100897 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared May 2010. https://www.510kdatabase.net/k101056/ 2010-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k101056-variax-elbow-system-fda-510k.jpg K101056 - VARIAX ELBOW SYSTEM K101056 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared May 2010. https://www.510kdatabase.net/k093905/ 2010-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k093905-trilogy-202-ventilator-fda-510k.jpg K093905 - TRILOGY 202 VENTILATOR K093905 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared May 2010. https://www.510kdatabase.net/k100235/ 2010-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k100235-filtek-supreme-ultra-flowable-fda-510k.jpg K100235 - FILTEK SUPREME ULTRA FLOWABLE RESTORATIVE K100235 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared May 2010. https://www.510kdatabase.net/k092190/ 2010-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k092190-synthes-distraction-osteogenesis-fda-510k.jpg K092190 - SYNTHES DISTRACTION OSTEOGENESIS SYSTEM, MR CONDITIONAL WITH EXPANDED INDICATIONS K092190 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared May 2010. https://www.510kdatabase.net/k092812/ 2010-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k092812-synthes-usa-27mm-35mm-lcp-fda-510k.jpg K092812 - SYNTHES (USA) 2.7MM/ 3.5MM LCP ANTEROLATERAL DISTAL TIBIA PLATES K092812 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared May 2010. https://www.510kdatabase.net/k093978/ 2010-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k093978-exactech-equinoxe-proximal-humerus-fda-510k.jpg K093978 - EXACTECH EQUINOXE PROXIMAL HUMERUS FRACTURE PLATE SYSTEM K093978 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared May 2010. https://www.510kdatabase.net/k100238/ 2010-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k100238-hfn-125-degree-9-13-mm-180mm-hfn-130-fda-510k.jpg K100238 - HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, HFN RH 125 DEGREE 9-13MM K100238 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared May 2010. https://www.510kdatabase.net/k100274/ 2010-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k100274-miar-minimally-invasive-aortic-root-fda-510k.jpg K100274 - MIAR (MINIMALLY INVASIVE AORTIC ROOT) CANNULA WITH FLOW-GUARD, MODELS 11012L AND 11014L K100274 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared May 2010. https://www.510kdatabase.net/k093747/ 2010-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k093747-align-and-align-to-urethral-support-fda-510k.jpg K093747 - ALIGN AND ALIGN TO URETHRAL SUPPORT SYSTEMS K093747 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 2010. https://www.510kdatabase.net/k100619/ 2010-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k100619-symbianet-symbianet-select-model-fda-510k.jpg K100619 - SYMBIA.NET, SYMBIA.NET SELECT MODEL 10520828, 10520827 K100619 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 2010. https://www.510kdatabase.net/k092467/ 2010-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k092467-vectorvision-cranial-vectorvision-ent-fda-510k.jpg K092467 - VECTORVISION CRANIAL, VECTORVISION ENT, KOLIBRI CRANIAL, KOLIBRI ENT, CRANIAL ESSENTIAL, CRANIAL UNLIMITED K092467 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared May 2010. https://www.510kdatabase.net/k100974/ 2010-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k100974-spectrum-turbo-ject-picc-set-fda-510k.jpg K100974 - SPECTRUM TURBO-JECT PICC SET K100974 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cook Incorporated. Cleared May 2010. https://www.510kdatabase.net/k100412/ 2010-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k100412-biolox-delta-ceramic-femoral-heads-fda-510k.jpg K100412 - BIOLOX DELTA CERAMIC FEMORAL HEADS K100412 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared May 2010. https://www.510kdatabase.net/k100830/ 2010-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k100830-m7m7t-diagnostic-ultrasound-system-fda-510k.jpg K100830 - M7/M7T DIAGNOSTIC ULTRASOUND SYSTEM K100830 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared May 2010. https://www.510kdatabase.net/k093737/ 2010-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k093737-hemosil-f11-fv-dna-control-fda-510k.jpg K093737 - HEMOSIL F11 & FV DNA CONTROL K093737 is a FDA 510(k) cleared pathology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared May 2010. https://www.510kdatabase.net/k100325/ 2010-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k100325-peri-loc-locking-hole-inserts-and-fda-510k.jpg K100325 - PERI-LOC LOCKING HOLE INSERTS AND CABLE ACCESSORIES K100325 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared May 2010. https://www.510kdatabase.net/k100423/ 2010-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k100423-dermabond-nx-adhesive-model-dnx6-dnx12-fda-510k.jpg K100423 - DERMABOND NX ADHESIVE MODEL: DNX6, DNX12 K100423 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared May 2010. https://www.510kdatabase.net/k091797/ 2010-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k091797-tsrh-spinal-system-fda-510k.jpg K091797 - TSRH SPINAL SYSTEM K091797 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Apr 2010. https://www.510kdatabase.net/k093235/ 2010-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k093235-ringloc-hybrid-acetabular-system-fda-510k.jpg K093235 - RINGLOC + HYBRID ACETABULAR SYSTEM K093235 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Apr 2010. https://www.510kdatabase.net/k100475/ 2010-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k100475-axsos-locked-plating-system-line-fda-510k.jpg K100475 - AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 5MM LOCKING INSERTS K100475 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Apr 2010. https://www.510kdatabase.net/k101041/ 2010-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k101041-dc-7-diagnostic-ultrasound-system-fda-510k.jpg K101041 - DC-7 DIAGNOSTIC ULTRASOUND SYSTEM K101041 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Apr 2010. https://www.510kdatabase.net/k093561/ 2010-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k093561-zimmer-trabecular-metal-modular-fda-510k.jpg K093561 - ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM K093561 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Apr 2010. https://www.510kdatabase.net/k100319/ 2010-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k100319-merit-manifold-with-integrated-fda-510k.jpg K100319 - MERIT MANIFOLD WITH INTEGRATED TRANSDUCER, MODEL 203LTCHN-R K100319 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Apr 2010. https://www.510kdatabase.net/k100866/ 2010-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k100866-profemur-hip-system-modular-necks-fda-510k.jpg K100866 - PROFEMUR HIP SYSTEM MODULAR NECKS K100866 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Apr 2010. https://www.510kdatabase.net/k094031/ 2010-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k094031-elecsys-folate-iii-calcheck-5-fda-510k.jpg K094031 - ELECSYS FOLATE III CALCHECK 5 K094031 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Apr 2010. https://www.510kdatabase.net/k092748/ 2010-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k092748-sureshot-tan-nails-and-accessories-fda-510k.jpg K092748 - SURESHOT TAN NAILS AND ACCESSORIES K092748 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Apr 2010. https://www.510kdatabase.net/k094025/ 2010-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k094025-crescent-spinal-system-fda-510k.jpg K094025 - CRESCENT SPINAL SYSTEM K094025 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Apr 2010. https://www.510kdatabase.net/k100810/ 2010-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k100810-elecsys-c-peptide-calcheck-5-fda-510k.jpg K100810 - ELECSYS C-PEPTIDE CALCHECK 5 K100810 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Apr 2010. https://www.510kdatabase.net/k093421/ 2010-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k093421-elecsys-testosterone-ii-immunoassay-fda-510k.jpg K093421 - ELECSYS TESTOSTERONE II IMMUNOASSAY K093421 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Apr 2010. https://www.510kdatabase.net/k100283/ 2010-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k100283-versatube-tapered-tracheostomy-tube-fda-510k.jpg K100283 - VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTIC K100283 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Cook, Inc.. Cleared Apr 2010. https://www.510kdatabase.net/k090982/ 2010-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k090982-smith-nephew-hip-systems-with-ha-fda-510k.jpg K090982 - SMITH & NEPHEW HIP SYSTEMS WITH HA K090982 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Apr 2010. https://www.510kdatabase.net/k100229/ 2010-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k100229-ventrio-hernia-patch-fda-510k.jpg K100229 - VENTRIO HERNIA PATCH K100229 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 2010. https://www.510kdatabase.net/k100470/ 2010-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k100470-gtx-12-gidewire-fda-510k.jpg K100470 - GTX 12 GIDEWIRE K100470 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Apr 2010. https://www.510kdatabase.net/k100241/ 2010-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k100241-contiplex-d-continuous-nerve-block-set-fda-510k.jpg K100241 - CONTIPLEX D CONTINUOUS NERVE BLOCK SET, MODEL 331687, 331686, 331685, 331680 K100241 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Apr 2010. https://www.510kdatabase.net/k100663/ 2010-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k100663-contour-embolization-particles-models-fda-510k.jpg K100663 - CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321 K100663 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Boston Scientific Corporation. Cleared Apr 2010. https://www.510kdatabase.net/k093836/ 2010-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k093836-elecsys-tsh-calcheck-5-fda-510k.jpg K093836 - ELECSYS TSH CALCHECK 5 K093836 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Apr 2010. https://www.510kdatabase.net/k093991/ 2010-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k093991-slr-plus-standard-and-lateral-femoral-fda-510k.jpg K093991 - SLR-PLUS STANDARD AND LATERAL FEMORAL STEMS K093991 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Apr 2010. https://www.510kdatabase.net/k093361/ 2010-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k093361-synthes-air-pen-drive-apd-system-fda-510k.jpg K093361 - SYNTHES AIR PEN DRIVE (APD) SYSTEM K093361 is a FDA 510(k) cleared neurology medical device. Manufacturer: Synthes (Usa). Cleared Apr 2010. https://www.510kdatabase.net/k093746/ 2010-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k093746-verilast-wear-claims-for-the-legion-fda-510k.jpg K093746 - VERILAST WEAR CLAIMS FOR THE LEGION PRIMARY KNEE SYSTEM K093746 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Apr 2010. https://www.510kdatabase.net/k093554/ 2010-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k093554-retroflex-dilator-kit-fda-510k.jpg K093554 - RETROFLEX DILATOR KIT K093554 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Apr 2010. https://www.510kdatabase.net/k091022/ 2010-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k091022-modification-to-resert-xl-hld-high-fda-510k.jpg K091022 - MODIFICATION TO RESERT XL HLD HIGH LEVEL DISINFECTANT K091022 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Apr 2010. https://www.510kdatabase.net/k100111/ 2010-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k100111-ncb-periprosthetic-femur-polyaxial-fda-510k.jpg K100111 - NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM K100111 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Apr 2010. https://www.510kdatabase.net/k100892/ 2010-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k100892-renegade-hi-flo-fathom-kit-model-fda-510k.jpg K100892 - RENEGADE HI-FLO FATHOM KIT MODEL M001182XXX K100892 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Apr 2010. https://www.510kdatabase.net/k093394/ 2010-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k093394-bc-3200-auto-hematology-analyzerm-30d-fda-510k.jpg K093394 - BC-3200 AUTO HEMATOLOGY ANALYZER,M-30D DILUENT, M-30R RINSE, M-30CFL LYSE, M-30E-Z CLEANSER, M-30PROBE CLEANSER, BC-3D C K093394 is a FDA 510(k) cleared hematology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Apr 2010. https://www.510kdatabase.net/k093806/ 2010-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k093806-myknee-cutting-blocks-fda-510k.jpg K093806 - MYKNEE CUTTING BLOCKS K093806 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Apr 2010. https://www.510kdatabase.net/k100676/ 2010-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k100676-synthes-tomofixtm-meial-high-tibia-fda-510k.jpg K100676 - SYNTHES TOMOFIX(TM) MEIAL HIGH TIBIA PLATE, SMALL K100676 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Apr 2010. https://www.510kdatabase.net/k093845/ 2010-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k093845-ethicon-securestrap-5mm-absorbable-fda-510k.jpg K093845 - ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE, MODEL STRAP25 K093845 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Apr 2010. https://www.510kdatabase.net/k090036/ 2010-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k090036-system-15-sterile-processing-system-fda-510k.jpg K090036 - SYSTEM 1.5 STERILE PROCESSING SYSTEM K090036 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Apr 2010. https://www.510kdatabase.net/k093935/ 2010-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k093935-smith-nephew-footprint-rcx-pk-suture-fda-510k.jpg K093935 - SMITH & NEPHEW FOOTPRINT RCX PK SUTURE ANCHOR K093935 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Apr 2010. https://www.510kdatabase.net/k091955/ 2010-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k091955-stryker-sonicpin-system-fda-510k.jpg K091955 - STRYKER SONICPIN SYSTEM K091955 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Apr 2010. https://www.510kdatabase.net/k093555/ 2010-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k093555-cobas-u411-test-system-fda-510k.jpg K093555 - COBAS U411 TEST SYSTEM K093555 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Apr 2010. https://www.510kdatabase.net/k093844/ 2010-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k093844-smith-nephew-twinfix-ultra-ha-suture-fda-510k.jpg K093844 - SMITH & NEPHEW TWINFIX ULTRA HA SUTURE ANCHOR K093844 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Apr 2010. https://www.510kdatabase.net/k100594/ 2010-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k100594-elecsys-troponin-i-calcheck-5-fda-510k.jpg K100594 - ELECSYS TROPONIN I CALCHECK 5 K100594 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Apr 2010. https://www.510kdatabase.net/k100314/ 2010-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k100314-imns-medacta-navigation-system33221000us-fda-510k.jpg K100314 - IMNS MEDACTA NAVIGATION SYSTEM,33.221000US K100314 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medacta International S.A.. Cleared Mar 2010. https://www.510kdatabase.net/k100712/ 2010-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k100712-resound-endoscopic-ultrasound-fda-510k.jpg K100712 - RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE K100712 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Mar 2010. https://www.510kdatabase.net/k093582/ 2010-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k093582-elecsys-ck-mb-calcheck-5-fda-510k.jpg K093582 - ELECSYS CK-MB CALCHECK 5 K093582 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Mar 2010. https://www.510kdatabase.net/k093928/ 2010-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k093928-synthes-35mm-quadrilateral-surface-fda-510k.jpg K093928 - SYNTHES 3.5MM QUADRILATERAL SURFACE PLATES K093928 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Mar 2010. https://www.510kdatabase.net/k100579/ 2010-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k100579-g-force-ti-suture-anchor-system-fda-510k.jpg K100579 - G-FORCE TI SUTURE ANCHOR SYSTEM K100579 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Mar 2010. https://www.510kdatabase.net/k092437/ 2010-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k092437-codman-sterilization-containers-fda-510k.jpg K092437 - CODMAN STERILIZATION CONTAINERS K092437 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Mar 2010. https://www.510kdatabase.net/k100280/ 2010-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k100280-gyncare-morcellex-tissue-morcellator-fda-510k.jpg K100280 - GYNCARE MORCELLEX TISSUE MORCELLATOR K100280 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ethicon, Inc.. Cleared Mar 2010. https://www.510kdatabase.net/k093535/ 2010-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k093535-autolog-autotransfusion-system-fda-510k.jpg K093535 - AUTOLOG AUTOTRANSFUSION SYSTEM K093535 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Medtronic, Inc.. Cleared Mar 2010. https://www.510kdatabase.net/k093791/ 2010-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k093791-gore-dryseal-sheath-fda-510k.jpg K093791 - GORE DRYSEAL SHEATH K093791 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Mar 2010. https://www.510kdatabase.net/k092848/ 2010-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k092848-elecsys-troponin-t-calcheck-5-fda-510k.jpg K092848 - ELECSYS TROPONIN T CALCHECK 5 K092848 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Mar 2010. https://www.510kdatabase.net/k091741/ 2010-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k091741-tina-quant-ceruloplasmin-fda-510k.jpg K091741 - TINA-QUANT CERULOPLASMIN K091741 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics. Cleared Mar 2010. https://www.510kdatabase.net/k093460/ 2010-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k093460-coaguchek-xs-pro-system-fda-510k.jpg K093460 - COAGUCHEK XS PRO SYSTEM K093460 is a FDA 510(k) cleared hematology medical device. Manufacturer: Roche Diagnostics. Cleared Mar 2010. https://www.510kdatabase.net/k093603/ 2010-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k093603-storm-base-20-fda-510k.jpg K093603 - STORM-BASE 2.0 K093603 is a FDA 510(k) cleared radiology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Mar 2010. https://www.510kdatabase.net/k093912/ 2010-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k093912-arthrex-tibial-graftbolt-fda-510k.jpg K093912 - ARTHREX TIBIAL GRAFTBOLT K093912 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Mar 2010. https://www.510kdatabase.net/k093965/ 2010-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k093965-ultraverse-014-and-018-balloon-fda-510k.jpg K093965 - ULTRAVERSE 014 AND 018 BALLOON DILATATION CATHETERS K093965 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 2010. https://www.510kdatabase.net/k100395/ 2010-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k100395-harmony-vled-surgical-lightning-system-fda-510k.jpg K100395 - HARMONY VLED SURGICAL LIGHTNING SYSTEM K100395 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: STERIS Corporation. Cleared Mar 2010. https://www.510kdatabase.net/k100351/ 2010-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k100351-neuroscout-steerable-guidewire-fda-510k.jpg K100351 - NEUROSCOUT STEERABLE GUIDEWIRE K100351 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Mar 2010. https://www.510kdatabase.net/k100485/ 2010-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k100485-gynecare-tvt-exact-continence-system-fda-510k.jpg K100485 - GYNECARE TVT EXACT CONTINENCE SYSTEM K100485 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ethicon, Inc.. Cleared Mar 2010. https://www.510kdatabase.net/k091722/ 2010-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k091722-coaxial-applicator-system-fda-510k.jpg K091722 - COAXIAL APPLICATOR SYSTEM K091722 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Biomet, Inc.. Cleared Mar 2010. https://www.510kdatabase.net/k092265/ 2010-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k092265-vesafitcup-double-mobility-highcross-fda-510k.jpg K092265 - VESAFITCUP DOUBLE MOBILITY- HIGHCROSS HXUHMWPE LINERS K092265 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Mar 2010. https://www.510kdatabase.net/k092322/ 2010-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k092322-elecsys-rubella-igm-immunoassay-fda-510k.jpg K092322 - ELECSYS RUBELLA IGM IMMUNOASSAY K092322 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Diagnostics. Cleared Mar 2010. https://www.510kdatabase.net/k092181/ 2010-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k092181-hemosil-acustar-cardiolipin-igg-igm-fda-510k.jpg K092181 - HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS K092181 is a FDA 510(k) cleared immunology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Mar 2010. https://www.510kdatabase.net/k093668/ 2010-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k093668-synthes-matrix-mis-rods-fda-510k.jpg K093668 - SYNTHES MATRIX MIS RODS K093668 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Mar 2010. https://www.510kdatabase.net/k092740/ 2010-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k092740-architect-folate-reagents-architect-fda-510k.jpg K092740 - ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE CONTROLS, MODELS 1P74, 1P74, 1P74 K092740 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Mar 2010. https://www.510kdatabase.net/k092940/ 2010-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k092940-coaguchek-xs-plus-pst-system-fda-510k.jpg K092940 - COAGUCHEK XS PLUS PST SYSTEM K092940 is a FDA 510(k) cleared hematology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Mar 2010. https://www.510kdatabase.net/k093552/ 2010-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k093552-evolution-mp-total-knee-system-fda-510k.jpg K093552 - EVOLUTION MP TOTAL KNEE SYSTEM K093552 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Mar 2010. https://www.510kdatabase.net/k093700/ 2010-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k093700-elecsys-hcg-stat-calcheck-5-fda-510k.jpg K093700 - ELECSYS HCG STAT CALCHECK 5 K093700 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Mar 2010. https://www.510kdatabase.net/k090658/ 2010-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k090658-synthes-external-fixation-devices-mr-fda-510k.jpg K090658 - SYNTHES EXTERNAL FIXATION DEVICES, MR CONDITIONAL K090658 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Mar 2010. https://www.510kdatabase.net/k093812/ 2010-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k093812-acuson-s2000-diagnostic-ultrasound-fda-510k.jpg K093812 - ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM K093812 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2010. https://www.510kdatabase.net/k091025/ 2010-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k091025-chromid-vre-agar-model-ref-43-851-fda-510k.jpg K091025 - CHROMID VRE AGAR, MODEL: REF 43 851 K091025 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Mar 2010. https://www.510kdatabase.net/k091967/ 2010-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k091967-medacta-bipolar-head-fda-510k.jpg K091967 - MEDACTA BIPOLAR HEAD K091967 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Mar 2010. https://www.510kdatabase.net/k093203/ 2010-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k093203-cardioblate-bipolar-radiofrequency-fda-510k.jpg K093203 - CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM, MODELS 60831, 60832, 60841 K093203 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medtronic, Inc.. Cleared Feb 2010. https://www.510kdatabase.net/k093209/ 2010-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k093209-focus-tm-echogenic-nerve-stimulating-fda-510k.jpg K093209 - FOCUS ( TM) ECHOGENIC NERVE STIMULATING NEEDLE K093209 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Cook, Inc.. Cleared Feb 2010. https://www.510kdatabase.net/k092369/ 2010-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k092369-12sl-ecg-analysis-program-fda-510k.jpg K092369 - 12SL ECG ANALYSIS PROGRAM K092369 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Feb 2010. https://www.510kdatabase.net/k093621/ 2010-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k093621-syngopetct-oncology-fda-510k.jpg K093621 - SYNGO.PET&CT ONCOLOGY K093621 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 2010. https://www.510kdatabase.net/k100107/ 2010-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k100107-smith-nephew-sureshot-distal-targeting-fda-510k.jpg K100107 - SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V2.0 K100107 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Feb 2010. https://www.510kdatabase.net/k100227/ 2010-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k100227-sas-flualert-ab-sas-influenza-a-test-fda-510k.jpg K100227 - SAS FLUALERT A&B, SAS INFLUENZA A TEST K100227 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Feb 2010. https://www.510kdatabase.net/k093726/ 2010-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k093726-mediguard-nitrile-examination-glove-fda-510k.jpg K093726 - MEDIGUARD NITRILE EXAMINATION GLOVE- BLUE (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) K093726 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Feb 2010. https://www.510kdatabase.net/k093318/ 2010-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k093318-accelerator-aps-fda-510k.jpg K093318 - ACCELERATOR APS K093318 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Feb 2010. https://www.510kdatabase.net/k100197/ 2010-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k100197-genesis-unicondylar-uhmwpe-articular-fda-510k.jpg K100197 - GENESIS UNICONDYLAR UHMWPE ARTICULAR INSERTS K100197 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Feb 2010. https://www.510kdatabase.net/k100209/ 2010-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k100209-bd-eclipse-needle-with-smartslip-fda-510k.jpg K100209 - BD ECLIPSE NEEDLE WITH SMARTSLIP TECHNOLOGY K100209 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson & CO. Cleared Feb 2010. https://www.510kdatabase.net/k092590/ 2010-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k092590-pds-plates-fda-510k.jpg K092590 - PDS PLATES K092590 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Ethicon, Inc.. Cleared Feb 2010. https://www.510kdatabase.net/k093294/ 2010-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k093294-revere-stabilization-system-fda-510k.jpg K093294 - REVERE STABILIZATION SYSTEM K093294 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Feb 2010. https://www.510kdatabase.net/k093650/ 2010-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k093650-biotrend-oxygen-saturation-and-fda-510k.jpg K093650 - BIOTREND OXYGEN SATURATION AND HEMATOCRIT SYSTEM K093650 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Feb 2010. https://www.510kdatabase.net/k093004/ 2010-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k093004-impress-angiographic-catheter-with-fda-510k.jpg K093004 - IMPRESS ANGIOGRAPHIC CATHETER WITH HYDROPHILIC COATING K093004 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Feb 2010. https://www.510kdatabase.net/k100078/ 2010-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k100078-modified-straight-fire-laser-fiber-fda-510k.jpg K100078 - MODIFIED STRAIGHT FIRE LASER FIBER K100078 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Boston Scientific Corp. Cleared Feb 2010. https://www.510kdatabase.net/k090264/ 2010-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k090264-hemosil-d-dimer-hs-500-controls-fda-510k.jpg K090264 - HEMOSIL D-DIMER HS 500, CONTROLS K090264 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Feb 2010. https://www.510kdatabase.net/k092649/ 2010-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k092649-elecsys-probnp-ii-stat-immunoassay-and-fda-510k.jpg K092649 - ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS 05390109-160, 04842472-190 K092649 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Feb 2010. https://www.510kdatabase.net/k093142/ 2010-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k093142-target-detachable-coils-and-inzone-fda-510k.jpg K093142 - TARGET DETACHABLE COILS AND INZONE DETACHMENT SYSTEM K093142 is a FDA 510(k) cleared neurology medical device. Manufacturer: Boston Scientific Corp. Cleared Feb 2010. https://www.510kdatabase.net/k093846/ 2010-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k093846-longevity-it-highly-crosslinked-fda-510k.jpg K093846 - LONGEVITY IT HIGHLY CROSSLINKED POLYETHYLENE ELEVATED LINERS K093846 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Feb 2010. https://www.510kdatabase.net/k093927/ 2010-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k093927-6f-triple-lumen-powerline-central-fda-510k.jpg K093927 - 6F TRIPLE LUMEN POWERLINE CENTRAL VENOUS CATHETER, 5F DUAL LUMEN POWERLINE CENTRAL VENOUS CATHETER K093927 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Feb 2010. https://www.510kdatabase.net/k083764/ 2010-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k083764-amphetamines-ii-fda-510k.jpg K083764 - AMPHETAMINES II K083764 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Feb 2010. https://www.510kdatabase.net/k093474/ 2010-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k093474-depuy-fracture-and-fusion-plating-system-fda-510k.jpg K093474 - DEPUY FRACTURE AND FUSION PLATING SYSTEM K093474 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Feb 2010. https://www.510kdatabase.net/k100146/ 2010-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k100146-evolve-eps-ortholoc-fda-510k.jpg K100146 - EVOLVE EPS ORTHOLOC K100146 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Feb 2010. https://www.510kdatabase.net/k090755/ 2010-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k090755-quanta-lite-apspt-igg-and-igm-elisa-fda-510k.jpg K090755 - QUANTA LITE APS/PT IGG AND IGM ELISA K090755 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Feb 2010. https://www.510kdatabase.net/k093416/ 2010-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k093416-trilogy-200-ventilator-fda-510k.jpg K093416 - TRILOGY 200 VENTILATOR K093416 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Jan 2010. https://www.510kdatabase.net/k092508/ 2010-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k092508-fast-fix-360-meniscal-repair-system-fda-510k.jpg K092508 - FAST-FIX 360 MENISCAL REPAIR SYSTEM, STRIAGHT, CURVED, REVERSE CURVED,FAST FIX 360 AB MENISCAL REPAIR SYSTEM, STRAIGHT, K092508 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jan 2010. https://www.510kdatabase.net/k093433/ 2010-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k093433-variax-elbow-system-plate-line-extension-fda-510k.jpg K093433 - VARIAX ELBOW SYSTEM PLATE LINE EXTENSION K093433 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jan 2010. https://www.510kdatabase.net/k100067/ 2010-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k100067-model-viamo-ssa-640a-version-20-fda-510k.jpg K100067 - MODEL VIAMO SSA-640A, VERSION 2.0 ULTRASOUND SYSTEM K100067 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Jan 2010. https://www.510kdatabase.net/k093363/ 2010-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k093363-cocr-and-oxinium-femoral-heads-and-r3-fda-510k.jpg K093363 - COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS K093363 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jan 2010. https://www.510kdatabase.net/k093464/ 2010-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k093464-rapidsorb-plus-screw-system-fda-510k.jpg K093464 - RAPIDSORB PLUS SCREW SYSTEM K093464 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Jan 2010. https://www.510kdatabase.net/k092098/ 2010-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k092098-patient-specific-acetabular-fda-510k.jpg K092098 - PATIENT SPECIFIC ACETABULAR RECONSTRUCTION PROSTHESIS K092098 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jan 2010. https://www.510kdatabase.net/k092818/ 2010-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k092818-bipap-avaps-ventilatory-support-system-fda-510k.jpg K092818 - BIPAP AVAPS VENTILATORY SUPPORT SYSTEM K092818 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Jan 2010. https://www.510kdatabase.net/k093950/ 2010-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k093950-biofoam-bone-wedge-model-assorted-fda-510k.jpg K093950 - BIOFOAM BONE WEDGE MODEL ASSORTED K093950 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jan 2010. https://www.510kdatabase.net/k092250/ 2010-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k092250-medline-red-rubber-urethral-catheter-fda-510k.jpg K092250 - MEDLINE RED RUBBER URETHRAL CATHETER K092250 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medline Industries, Inc.. Cleared Jan 2010. https://www.510kdatabase.net/k093217/ 2010-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k093217-5-mm-harmonic-ace-instrument-used-with-fda-510k.jpg K093217 - 5 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM) K093217 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Jan 2010. https://www.510kdatabase.net/k093911/ 2010-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k093911-fogarty-occlusion-catheter-fda-510k.jpg K093911 - FOGARTY OCCLUSION CATHETER K093911 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Jan 2010. https://www.510kdatabase.net/k093944/ 2010-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k093944-medacta-total-hip-prothesis-system-fda-510k.jpg K093944 - MEDACTA TOTAL HIP PROTHESIS SYSTEM-AMISTEN H , QUADRA H, QUADRA S K093944 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Jan 2010. https://www.510kdatabase.net/k093947/ 2010-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k093947-alimaxx-b-uncovered-biliary-stent-fda-510k.jpg K093947 - ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM ENDOSCOPIC K093947 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jan 2010. https://www.510kdatabase.net/k093972/ 2010-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k093972-bd-microtainer-map-microtube-for-fda-510k.jpg K093972 - BD MICROTAINER MAP MICROTUBE FOR AUTOMATED PROCESS, MODEL 363706 K093972 is a FDA 510(k) cleared hematology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Jan 2010. https://www.510kdatabase.net/k093659/ 2010-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k093659-eclipse-filter-system-femoral-delivery-fda-510k.jpg K093659 - ECLIPSE FILTER SYSTEM-FEMORAL DELIVERY KIT, ECLIPSE FILTER SYSTEM-JUGULAR/SUBCLAVIAN DELIVERY KIT MODEL RF500F MODEL RF5 K093659 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 2010. https://www.510kdatabase.net/k093730/ 2010-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k093730-port-access-systems-endodirect-fda-510k.jpg K093730 - PORT ACCESS SYSTEMS ENDODIRECT ARTERIAL CANNULA MODEL ED24 (OLD CODE WAS-DFK24) K093730 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Jan 2010. https://www.510kdatabase.net/k092909/ 2010-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k092909-synthes-73-mm-cannulated-slipped-fda-510k.jpg K092909 - SYNTHES 7.3 MM CANNULATED SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREWS (SCFE) K092909 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jan 2010. https://www.510kdatabase.net/k093360/ 2010-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k093360-optetrak-logic-total-knee-system-fda-510k.jpg K093360 - OPTETRAK LOGIC TOTAL KNEE SYSTEM TRAPEZOIDAL TIBIAL TRAY, SIZES 2.5F/1.5T-3.5F/4.5T K093360 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Jan 2010. https://www.510kdatabase.net/k093469/ 2010-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k093469-ciaglia-blue-dolphin-balloon-fda-510k.jpg K093469 - CIAGLIA BLUE DOLPHIN BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER, MODEL: MULTIPLE, PREFIX C-PTBS K093469 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Cook, Inc.. Cleared Jan 2010. https://www.510kdatabase.net/k092900/ 2010-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k092900-exactech-equinoxe-platform-fracture-fda-510k.jpg K092900 - EXACTECH EQUINOXE PLATFORM FRACTURE STEM AND REVISION PLATFORM FRACTURE STEM K092900 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Jan 2010. https://www.510kdatabase.net/k093349/ 2010-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k093349-medline-curad-wound-dressings-fda-510k.jpg K093349 - MEDLINE CURAD WOUND DRESSINGS K093349 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medline Industries, Inc.. Cleared Jan 2010. https://www.510kdatabase.net/k092087/ 2009-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k092087-medtronic-dental-tcp-fda-510k.jpg K092087 - MEDTRONIC DENTAL TCP K092087 is a FDA 510(k) cleared dental medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Dec 2009. https://www.510kdatabase.net/k092906/ 2009-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k092906-verify-biological-indicator-challenge-fda-510k.jpg K092906 - VERIFY BIOLOGICAL INDICATOR CHALLENGE PACK FOR VAPORIZED VH202 STERILIZATION K092906 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Dec 2009. https://www.510kdatabase.net/k092929/ 2009-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k092929-synthes-matrix-system-fda-510k.jpg K092929 - SYNTHES MATRIX SYSTEM K092929 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Dec 2009. https://www.510kdatabase.net/k093141/ 2009-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k093141-mars-holter-analysis-workstation-fda-510k.jpg K093141 - MARS HOLTER ANALYSIS WORKSTATION K093141 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Dec 2009. https://www.510kdatabase.net/k091644/ 2009-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k091644-synthes-usa-24mm-lcp-volar-column-fda-510k.jpg K091644 - SYNTHES (USA) 2.4MM LCP VOLAR COLUMN DISTAL RADIUS PLATES K091644 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Dec 2009. https://www.510kdatabase.net/k093242/ 2009-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k093242-patriot-transcontinental-llif-spacer-fda-510k.jpg K093242 - PATRIOT TRANSCONTINENTAL LLIF SPACER K093242 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Dec 2009. https://www.510kdatabase.net/k093636/ 2009-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k093636-sterling-es-monorail-and-over-the-wire-fda-510k.jpg K093636 - STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS MODEL H74939334XXXXXXX K093636 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Dec 2009. https://www.510kdatabase.net/k093663/ 2009-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k093663-radionuclide-brachytherapy-source-fda-510k.jpg K093663 - RADIONUCLIDE BRACHYTHERAPY SOURCE K093663 is a FDA 510(k) cleared radiology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 2009. https://www.510kdatabase.net/k093720/ 2009-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k093720-sterling-sl-monorail-pta-balloon-fda-510k.jpg K093720 - STERLING SL MONORAIL PTA BALLOON DILATATION CATHETERS STERLING SL OVER-THE-WIRE BALLOON DILATATION CATHETERS MODEL VARIO K093720 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Dec 2009. https://www.510kdatabase.net/k091543/ 2009-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k091543-legion-porous-plus-ha-primary-femoral-fda-510k.jpg K091543 - LEGION POROUS PLUS HA PRIMARY FEMORAL COMPONENTS K091543 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Dec 2009. https://www.510kdatabase.net/k092483/ 2009-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k092483-bard-permafix-fixation-system-model-fda-510k.jpg K092483 - BARD PERMAFIX FIXATION SYSTEM, MODEL 0113012, 0113014, 0113016, 0116018 K092483 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 2009. https://www.510kdatabase.net/k092823/ 2009-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k092823-amsco-warming-cabinet-fda-510k.jpg K092823 - AMSCO WARMING CABINET K092823 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Dec 2009. https://www.510kdatabase.net/k093644/ 2009-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k093644-restoration-adm-system-x3-acetabular-fda-510k.jpg K093644 - RESTORATION ADM SYSTEM X3 ACETABULAR K093644 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Dec 2009. https://www.510kdatabase.net/k093646/ 2009-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k093646-depuy-pinnacle-with-gription-fda-510k.jpg K093646 - DEPUY PINNACLE WITH GRIPTION ACETABULAR CUPS K093646 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Dec 2009. https://www.510kdatabase.net/k090993/ 2009-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k090993-intuitive-surgical-endoscopic-fda-510k.jpg K090993 - INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEMS, MODELS IS1200, IS2000 AND IS3000 K090993 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Dec 2009. https://www.510kdatabase.net/k092169/ 2009-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k092169-elecsys-probnp-ii-calcheck-5-fda-510k.jpg K092169 - ELECSYS PROBNP II CALCHECK 5 K092169 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Dec 2009. https://www.510kdatabase.net/k092325/ 2009-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k092325-modification-tocd-horizon-spinal-system-fda-510k.jpg K092325 - MODIFICATION TO:CD HORIZON SPINAL SYSTEM K092325 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Dec 2009. https://www.510kdatabase.net/k093056/ 2009-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k093056-smith-nephew-inc-journey-select-knee-fda-510k.jpg K093056 - SMITH & NEPHEW, INC. JOURNEY SELECT KNEE SYSTEM K093056 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Dec 2009. https://www.510kdatabase.net/k093228/ 2009-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k093228-smith-nephew-twinfix-ultra-pk-suture-fda-510k.jpg K093228 - SMITH & NEPHEW TWINFIX ULTRA PK SUTURE ANCHOR K093228 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Dec 2009. https://www.510kdatabase.net/k093527/ 2009-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k093527-aria-radiation-oncology-with-mirs-fda-510k.jpg K093527 - ARIA RADIATION ONCOLOGY WITH MIRS K093527 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Dec 2009. https://www.510kdatabase.net/k091233/ 2009-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k091233-synthes-matrixmandible-subcondylar-fda-510k.jpg K091233 - SYNTHES MATRIXMANDIBLE SUBCONDYLAR PLATES K091233 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Dec 2009. https://www.510kdatabase.net/k092505/ 2009-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k092505-beckman-coulter-ferritin-reagent-model-fda-510k.jpg K092505 - BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203 K092505 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Dec 2009. https://www.510kdatabase.net/k093117/ 2009-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k093117-digital-lightbox-fda-510k.jpg K093117 - DIGITAL LIGHTBOX K093117 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab AG. Cleared Dec 2009. https://www.510kdatabase.net/k093691/ 2009-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k093691-accumax-fda-510k.jpg K093691 - ACCUMAX K093691 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Boston Scientific Corp. Cleared Dec 2009. https://www.510kdatabase.net/k092002/ 2009-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k092002-afghan-external-fixator-fda-510k.jpg K092002 - AFGHAN EXTERNAL FIXATOR K092002 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Dec 2009. https://www.510kdatabase.net/k093052/ 2009-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k093052-crosscath-support-cathter-fda-510k.jpg K093052 - CROSSCATH SUPPORT CATHTER K093052 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Dec 2009. https://www.510kdatabase.net/k091582/ 2009-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k091582-gtx-guidewire-models-tbd-gtx-1-36912-15-fda-510k.jpg K091582 - GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15 K091582 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Dec 2009. https://www.510kdatabase.net/k092603/ 2009-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k092603-cobas-integra-glucose-hk-gen-3-assay-fda-510k.jpg K092603 - COBAS INTEGRA GLUCOSE HK GEN 3 ASSAY K092603 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Dec 2009. https://www.510kdatabase.net/k093171/ 2009-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k093171-viamo-ssa-640a-version-12-fda-510k.jpg K093171 - VIAMO SSA-640A VERSION 1.2 K093171 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Dec 2009. https://www.510kdatabase.net/k093199/ 2009-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k093199-3m-comply-bowie-dick-type-lead-free-fda-510k.jpg K093199 - 3M COMPLY BOWIE- DICK TYPE LEAD FREE TEST PACK K093199 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Dec 2009. https://www.510kdatabase.net/k093458/ 2009-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k093458-synchron-systems-enzymatic-creatinine-fda-510k.jpg K093458 - SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298 K093458 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Dec 2009. https://www.510kdatabase.net/k093434/ 2009-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k093434-vertex-reconstruction-system-and-fda-510k.jpg K093434 - VERTEX RECONSTRUCTION SYSTEM AND VERTEX SELECT RECONSTRUCTION SYSTEM K093434 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Dec 2009. https://www.510kdatabase.net/k092871/ 2009-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k092871-trilogy-mx-fda-510k.jpg K092871 - TRILOGY MX K092871 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Nov 2009. https://www.510kdatabase.net/k092178/ 2009-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k092178-axsos-stryker-locked-plating-system-fda-510k.jpg K092178 - AXSOS STRYKER LOCKED PLATING SYSTEM LINE EXTENSION OF CABLE PLUGS K092178 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Nov 2009. https://www.510kdatabase.net/k092607/ 2009-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k092607-ajust-adjustable-single-incision-sling-fda-510k.jpg K092607 - AJUST ADJUSTABLE SINGLE INCISION SLING K092607 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 2009. https://www.510kdatabase.net/k091813/ 2009-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k091813-intrepid-spinal-system-fda-510k.jpg K091813 - INTREPID SPINAL SYSTEM K091813 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Nov 2009. https://www.510kdatabase.net/k092271/ 2009-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k092271-ge-logiq-e9-bt2010-diagnostic-fda-510k.jpg K092271 - GE LOGIQ E9 BT2010 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 5205000-3, 5205000-4 K092271 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Nov 2009. https://www.510kdatabase.net/k092556/ 2009-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k092556-synthes-usa-24mm-va-lcp-two-column-fda-510k.jpg K092556 - SYNTHES (USA) 2.4MM VA-LCP TWO-COLUMN NARROW VOLAR DISTAL RADIUS K092556 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Nov 2009. https://www.510kdatabase.net/k092609/ 2009-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k092609-synthes-35-mm-and-455-mm-curved-narrow-fda-510k.jpg K092609 - SYNTHES 3.5 MM AND 4.55 MM CURVED NARROW AND BROAD LOCKING COMPRESSION PLATES (LCP) K092609 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Nov 2009. https://www.510kdatabase.net/k093291/ 2009-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k093291-varian-interstitial-titanium-needles-fda-510k.jpg K093291 - VARIAN INTERSTITIAL TITANIUM NEEDLES K093291 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Nov 2009. https://www.510kdatabase.net/k092146/ 2009-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k092146-xtend-anterior-cervical-plate-system-fda-510k.jpg K092146 - XTEND ANTERIOR CERVICAL PLATE SYSTEM K092146 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Nov 2009. https://www.510kdatabase.net/k092168/ 2009-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k092168-elecsys-hcgb-calcheck-5-fda-510k.jpg K092168 - ELECSYS HCG+B CALCHECK 5 K092168 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Nov 2009. https://www.510kdatabase.net/k091724/ 2009-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k091724-bd-probetec-chlamydia-trachomatis-ct-q-fda-510k.jpg K091724 - BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY K091724 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Nov 2009. https://www.510kdatabase.net/k091730/ 2009-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k091730-bd-probetec-neisseria-gonorrhoeae-gc-fda-510k.jpg K091730 - BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY K091730 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Nov 2009. https://www.510kdatabase.net/k090739/ 2009-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k090739-bard-sacrocolpopexy-graft-fda-510k.jpg K090739 - BARD SACROCOLPOPEXY GRAFT K090739 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 2009. https://www.510kdatabase.net/k092888/ 2009-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k092888-elecsys-toxo-igg-calcheck-5-fda-510k.jpg K092888 - ELECSYS TOXO IGG CALCHECK 5 K092888 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Nov 2009. https://www.510kdatabase.net/k093068/ 2009-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k093068-finesse-ultra-breast-biospy-system-fda-510k.jpg K093068 - FINESSE ULTRA BREAST BIOSPY SYSTEM DRIVER - BLUE, PINK, PROBE FO1BLU, FOIPNK, F14105US K093068 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 2009. https://www.510kdatabase.net/k093224/ 2009-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k093224-densicheck-plus-fda-510k.jpg K093224 - DENSICHECK PLUS K093224 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Nov 2009. https://www.510kdatabase.net/k090605/ 2009-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k090605-clampfix-fda-510k.jpg K090605 - CLAMPFIX K090605 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Nov 2009. https://www.510kdatabase.net/k092009/ 2009-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k092009-modification-to-leveen-superslim-fda-510k.jpg K092009 - MODIFICATION TO: LEVEEN SUPERSLIM NEEDLE ELECTRODES, MODELS M001262260, M001262270, M001262280, M001262290 K092009 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Boston Scientific Corporation. Cleared Nov 2009. https://www.510kdatabase.net/k093184/ 2009-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k093184-envoy-guiding-catheters-fda-510k.jpg K093184 - ENVOY GUIDING CATHETERS K093184 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Nov 2009. https://www.510kdatabase.net/k092313/ 2009-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k092313-perfusor-space-infusion-syringe-pump-fda-510k.jpg K092313 - PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM K092313 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Nov 2009. https://www.510kdatabase.net/k092406/ 2009-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k092406-abg-ii-modular-hip-stem-fda-510k.jpg K092406 - ABG II MODULAR HIP STEM K092406 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Nov 2009. https://www.510kdatabase.net/k092490/ 2009-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k092490-amsco-evolution-series-steam-fda-510k.jpg K092490 - AMSCO EVOLUTION SERIES STEAM STERILIZER, MODEL: HC-2000 AND HC-3000 K092490 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Nov 2009. https://www.510kdatabase.net/k092320/ 2009-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k092320-elecsys-precicontrol-thyroab-fda-510k.jpg K092320 - ELECSYS PRECICONTROL THYROAB K092320 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Nov 2009. https://www.510kdatabase.net/k092386/ 2009-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k092386-r3-multi-hole-shells-and-36mm-xlpe-fda-510k.jpg K092386 - R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS K092386 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Nov 2009. https://www.510kdatabase.net/k092585/ 2009-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k092585-elecsys-rubella-igga-calcheck-5-fda-510k.jpg K092585 - ELECSYS RUBELLA IGGA CALCHECK 5 K092585 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Diagnostics. Cleared Oct 2009. https://www.510kdatabase.net/k091174/ 2009-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k091174-verify-v-pro-chemical-indicator-fda-510k.jpg K091174 - VERIFY V-PRO CHEMICAL INDICATOR, VERSION 1A: VERIFY V-PRO CHEMICAL INDICATOR K091174 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Oct 2009. https://www.510kdatabase.net/k092150/ 2009-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k092150-cobalt-mv-with-gentamicin-aka-cobalt-g-fda-510k.jpg K092150 - COBALT MV WITH GENTAMICIN (AKA COBALT G-MV) BONE CEMENT K092150 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Oct 2009. https://www.510kdatabase.net/k092303/ 2009-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k092303-merit-laureate-hydrophilic-guide-wire-fda-510k.jpg K092303 - MERIT LAUREATE HYDROPHILIC GUIDE WIRE K092303 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Oct 2009. https://www.510kdatabase.net/k090897/ 2009-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k090897-tritanium-non-modular-shell-x3-all-fda-510k.jpg K090897 - TRITANIUM NON-MODULAR SHELL & X3 ALL-POLY INSERT K090897 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Oct 2009. https://www.510kdatabase.net/k092561/ 2009-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k092561-rejuvenate-modular-stem-fda-510k.jpg K092561 - REJUVENATE MODULAR STEM K092561 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Oct 2009. https://www.510kdatabase.net/k083260/ 2009-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k083260-elecsys-myoglobin-stat-and-elecsys-fda-510k.jpg K083260 - ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN K083260 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Oct 2009. https://www.510kdatabase.net/k091846/ 2009-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k091846-synchron-systems-g7-amylase-amy7-fda-510k.jpg K091846 - SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607 K091846 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Oct 2009. https://www.510kdatabase.net/k092691/ 2009-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k092691-dc-7-diagnostic-ultrasound-system-fda-510k.jpg K092691 - DC-7 DIAGNOSTIC ULTRASOUND SYSTEM K092691 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Oct 2009. https://www.510kdatabase.net/k091709/ 2009-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k091709-multi-med-central-venous-catheters-fda-510k.jpg K091709 - MULTI-MED CENTRAL VENOUS CATHETERS, MODELS: M3720HKIC, M4820HKIC K091709 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Oct 2009. https://www.510kdatabase.net/k090563/ 2009-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k090563-hemosil-inr-validate-hemosil-isi-fda-510k.jpg K090563 - HEMOSIL INR VALIDATE, HEMOSIL ISI CALIBRATE, ISIWEB (SOFTWARE) K090563 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Oct 2009. https://www.510kdatabase.net/k091584/ 2009-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k091584-merit-mak-mini-access-kit-with-fda-510k.jpg K091584 - MERIT MAK (MINI ACCESS KIT) WITH PALLADIUM TIP GUIDE WIRE K091584 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Oct 2009. https://www.510kdatabase.net/k092747/ 2009-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k092747-philips-comprehensive-cardiac-analysis-fda-510k.jpg K092747 - PHILIPS COMPREHENSIVE CARDIAC ANALYSIS (CCA) - PLAQUE ASSESSMENT TOOL K092747 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Oct 2009. https://www.510kdatabase.net/k092948/ 2009-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k092948-aplio-mx-ssa-780a-version-10-fda-510k.jpg K092948 - APLIO MX SSA-780A, VERSION 1.0 K092948 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Oct 2009. https://www.510kdatabase.net/k092509/ 2009-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k092509-edwards-lifesciences-venous-return-fda-510k.jpg K092509 - EDWARDS LIFESCIENCES VENOUS RETURN CANNULAE K092509 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Oct 2009. https://www.510kdatabase.net/k092834/ 2009-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k092834-hoffman-xpress-line-extension-fda-510k.jpg K092834 - HOFFMAN XPRESS LINE EXTENSION K092834 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Oct 2009. https://www.510kdatabase.net/k090568/ 2009-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k090568-medline-nitrile-exam-gloves-waloe-green-fda-510k.jpg K090568 - MEDLINE NITRILE EXAM GLOVES W/ALOE -GREEN K090568 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Oct 2009. https://www.510kdatabase.net/k092666/ 2009-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k092666-inzone-detachment-system-model-fda-510k.jpg K092666 - INZONE DETACHMENT SYSTEM, MODEL M00345100940, IZDS CONNECTING CABLE, MODEL M00345100250 K092666 is a FDA 510(k) cleared neurology medical device. Manufacturer: Boston Scientific Corp. Cleared Sep 2009. https://www.510kdatabase.net/k090353/ 2009-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k090353-perimeter-interbody-fusion-device-fda-510k.jpg K090353 - PERIMETER INTERBODY FUSION DEVICE K090353 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Sep 2009. https://www.510kdatabase.net/k091014/ 2009-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k091014-journey-bcs-knee-system-fda-510k.jpg K091014 - JOURNEY BCS KNEE SYSTEM K091014 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Sep 2009. https://www.510kdatabase.net/k090757/ 2009-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k090757-biomet-modular-femoral-revision-system-fda-510k.jpg K090757 - BIOMET MODULAR FEMORAL REVISION SYSTEM K090757 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Sep 2009. https://www.510kdatabase.net/k091601/ 2009-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k091601-elecys-anti-ccp-calcheck-fda-510k.jpg K091601 - ELECYS ANTI-CCP CALCHECK K091601 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Sep 2009. https://www.510kdatabase.net/k092247/ 2009-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k092247-synthes-locking-hand-plates-fda-510k.jpg K092247 - SYNTHES LOCKING HAND PLATES K092247 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Sep 2009. https://www.510kdatabase.net/k092646/ 2009-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k092646-synthes-usa-trochanteric-fixation-nail-fda-510k.jpg K092646 - SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SCREW K092646 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Sep 2009. https://www.510kdatabase.net/k092610/ 2009-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k092610-modification-to-beacon-stabilization-fda-510k.jpg K092610 - MODIFICATION TO BEACON STABILIZATION SYSTEM K092610 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Sep 2009. https://www.510kdatabase.net/k092671/ 2009-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k092671-variax-elbow-system-line-extension-fda-510k.jpg K092671 - VARIAX ELBOW SYSTEM LINE EXTENSION K092671 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Sep 2009. https://www.510kdatabase.net/k091980/ 2009-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k091980-acl-top-700-las-fda-510k.jpg K091980 - ACL TOP 700 LAS K091980 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 2009. https://www.510kdatabase.net/k091883/ 2009-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k091883-t2-spinal-system-fda-510k.jpg K091883 - T2 SPINAL SYSTEM K091883 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Sep 2009. https://www.510kdatabase.net/k092145/ 2009-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k092145-160mlc-option-fda-510k.jpg K092145 - 160MLC OPTION K092145 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 2009. https://www.510kdatabase.net/k091731/ 2009-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k091731-amsco-evolution-medium-steam-sterilizer-fda-510k.jpg K091731 - AMSCO EVOLUTION MEDIUM STEAM STERILIZER K091731 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Sep 2009. https://www.510kdatabase.net/k091968/ 2009-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k091968-karl-storz-led-nova-100-cold-light-fda-510k.jpg K091968 - KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020C K091968 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Sep 2009. https://www.510kdatabase.net/k083536/ 2009-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k083536-densichek-plus-fda-510k.jpg K083536 - DENSICHEK PLUS K083536 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Sep 2009. https://www.510kdatabase.net/k091508/ 2009-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k091508-zimmer-continuum-acetabular-system-fda-510k.jpg K091508 - ZIMMER CONTINUUM ACETABULAR SYSTEM, ZIMMER TRILOGY IT ACETABULAR SYSTEM K091508 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Sep 2009. https://www.510kdatabase.net/k091799/ 2009-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k091799-cable-ready-cable-grip-system-cable-fda-510k.jpg K091799 - CABLE READY CABLE GRIP SYSTEM CABLE BUTTON K091799 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Sep 2009. https://www.510kdatabase.net/k092497/ 2009-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k092497-smith-nephew-pigalileo-screw-targeting-fda-510k.jpg K092497 - SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM, VERSION 1.1 K092497 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Sep 2009. https://www.510kdatabase.net/k091921/ 2009-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k091921-codman-aneurysm-clips-codman-avm-micro-fda-510k.jpg K091921 - CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REINFORCING, MINI ANEURYSM CLIP K091921 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Sep 2009. https://www.510kdatabase.net/k092455/ 2009-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k092455-modification-to-polarcath-peripheral-fda-510k.jpg K092455 - MODIFICATION TO: POLARCATH PERIPHERAL DILATATION SYSTEM K092455 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Sep 2009. https://www.510kdatabase.net/k091632/ 2009-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k091632-spk-sealant-fda-510k.jpg K091632 - SPK SEALANT K091632 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Sep 2009. https://www.510kdatabase.net/k091974/ 2009-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k091974-modification-to-cd-horizon-spinal-system-fda-510k.jpg K091974 - MODIFICATION TO CD HORIZON SPINAL SYSTEM K091974 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Sep 2009. https://www.510kdatabase.net/k083665/ 2009-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k083665-verify-scbi-275f-3-10-fda-510k.jpg K083665 - VERIFY SCBI 275F 3-10 K083665 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Sep 2009. https://www.510kdatabase.net/k092419/ 2009-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k092419-axsos-locked-plating-system-line-fda-510k.jpg K092419 - AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 3MM LOCKING INSERTS K092419 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Sep 2009. https://www.510kdatabase.net/k091844/ 2009-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k091844-arthrex-bio-composite-suturetak-anchors-fda-510k.jpg K091844 - ARTHREX BIO-COMPOSITE SUTURETAK ANCHORS K091844 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Aug 2009. https://www.510kdatabase.net/k092027/ 2009-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k092027-carescape-monitor-b850-fda-510k.jpg K092027 - CARESCAPE MONITOR B850 K092027 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Aug 2009. https://www.510kdatabase.net/k083270/ 2009-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k083270-wmt-composite-dbm-fda-510k.jpg K083270 - WMT COMPOSITE DBM K083270 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Aug 2009. https://www.510kdatabase.net/k083867/ 2009-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k083867-access-sex-hormone-binding-globulin-fda-510k.jpg K083867 - ACCESS SEX HORMONE BINDING GLOBULIN REAGENT, ACCESS SEX HORMONE BINDING GLOBULIN CALIBRATORS AND ACCESS SEX HORMONE BIND K083867 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Aug 2009. https://www.510kdatabase.net/k091144/ 2009-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k091144-synthes-matrixmandible-preformed-fda-510k.jpg K091144 - SYNTHES MATRIXMANDIBLE PREFORMED RECONSTRUCTION PLATES K091144 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Aug 2009. https://www.510kdatabase.net/k091423/ 2009-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k091423-profemur-hip-system-modular-necks-fda-510k.jpg K091423 - PROFEMUR HIP SYSTEM MODULAR NECKS K091423 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Aug 2009. https://www.510kdatabase.net/k092004/ 2009-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k092004-ge-innova-solid-state-xray-imager-fda-510k.jpg K092004 - GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODEL: 4100IQ, 3100IQ, 2100IQ K092004 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Aug 2009. https://www.510kdatabase.net/k092201/ 2009-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k092201-advance-913-medial-pivot-tibial-insert-fda-510k.jpg K092201 - ADVANCE 913 MEDIAL PIVOT TIBIAL INSERT, ADVANCE 913 MEDIAL PIVOT TIBIAL BASE K092201 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Aug 2009. https://www.510kdatabase.net/k082699/ 2009-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k082699-elecsys-troponin-i-and-troponin-i-stat-fda-510k.jpg K082699 - ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS K082699 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Aug 2009. https://www.510kdatabase.net/k090818/ 2009-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k090818-karl-storz-endoscope-sterilization-fda-510k.jpg K090818 - KARL STORZ -ENDOSCOPE STERILIZATION TRAYS, MODELS 39402AS, 39301HCTS, 39301BS K090818 is a FDA 510(k) cleared general hospital medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Aug 2009. https://www.510kdatabase.net/k090740/ 2009-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k090740-modification-to-tsrh-spinal-system-fda-510k.jpg K090740 - MODIFICATION TO: TSRH SPINAL SYSTEM K090740 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Aug 2009. https://www.510kdatabase.net/k090995/ 2009-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k090995-b-braun-contiplex-continuous-nerve-fda-510k.jpg K090995 - B. BRAUN CONTIPLEX CONTINUOUS NERVE BLOCK SET K090995 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Aug 2009. https://www.510kdatabase.net/k091742/ 2009-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k091742-synchron-systems-enzymatic-creatinine-fda-510k.jpg K091742 - SYNCHRON SYSTEMS ENZYMATIC CREATININE (CR-E) REAGENT, MODEL A60298 K091742 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Aug 2009. https://www.510kdatabase.net/k091899/ 2009-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k091899-vitek-2-gram-negative-meropenem-fda-510k.jpg K091899 - VITEK 2 GRAM NEGATIVE MEROPENEM K091899 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Aug 2009. https://www.510kdatabase.net/k091782/ 2009-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k091782-revere-635-stabilization-system-fda-510k.jpg K091782 - REVERE 6.35 STABILIZATION SYSTEM K091782 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Aug 2009. https://www.510kdatabase.net/k092108/ 2009-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k092108-truss-thoracolumbar-plate-system-fda-510k.jpg K092108 - TRUSS THORACOLUMBAR PLATE SYSTEM K092108 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Aug 2009. https://www.510kdatabase.net/k091453/ 2009-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k091453-lps-universal-tibial-hinge-inserts-fda-510k.jpg K091453 - LPS UNIVERSAL TIBIAL HINGE INSERTS, MODEL 198727012-198727331 K091453 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Aug 2009. https://www.510kdatabase.net/k083643/ 2009-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k083643-verify-275f-gravity-indicators-fda-510k.jpg K083643 - VERIFY 275F GRAVITY INDICATORS K083643 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Aug 2009. https://www.510kdatabase.net/k090002/ 2009-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k090002-acid-concentrate-45x-20k-31ca-model-fda-510k.jpg K090002 - ACID CONCENTRATE 45X (2.0K, 3.1CA), MODEL 5M8001A, ACID CONCENTRATE 45X (2.0K, 2.5CA), MODEL 5M8002A K090002 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Aug 2009. https://www.510kdatabase.net/k091324/ 2009-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k091324-sherlock-3cg-tip-positioning-system-fda-510k.jpg K091324 - SHERLOCK 3CG TIP POSITIONING SYSTEM, SHERLOCK 3CG TIP POSITIONING SYSTEM STYLET K091324 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Aug 2009. https://www.510kdatabase.net/k091385/ 2009-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k091385-approach-hydro-st-wire-guide-model-hmw-fda-510k.jpg K091385 - APPROACH HYDRO ST WIRE GUIDE, MODEL HMW K091385 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Aug 2009. https://www.510kdatabase.net/k092343/ 2009-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k092343-en-snare-endovascular-snare-system-fda-510k.jpg K092343 - EN SNARE ENDOVASCULAR SNARE SYSTEM K092343 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Aug 2009. https://www.510kdatabase.net/k090107/ 2009-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k090107-mini-tightrope-fda-510k.jpg K090107 - MINI TIGHTROPE K090107 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Aug 2009. https://www.510kdatabase.net/k092043/ 2009-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k092043-bipap-synchrony-2-fda-510k.jpg K092043 - BIPAP SYNCHRONY 2 K092043 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Aug 2009. https://www.510kdatabase.net/k083097/ 2009-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k083097-amsco-v-pro-1-low-temperature-fda-510k.jpg K083097 - AMSCO V-PRO 1 LOW TEMPERATURE STERILIZATION SYSTEM K083097 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Aug 2009. https://www.510kdatabase.net/k083707/ 2009-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k083707-arthrex-dual-wave-arthroscopy-fluid-fda-510k.jpg K083707 - ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE K083707 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Aug 2009. https://www.510kdatabase.net/k091659/ 2009-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k091659-bard-3dmax-light-mesh-models-0117310-fda-510k.jpg K091659 - BARD 3DMAX LIGHT MESH, MODELS: 0117310, 0117311, 0117312, 0117320, 0117321, 011732 K091659 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Aug 2009. https://www.510kdatabase.net/k090949/ 2009-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k090949-synthes-usa-15mm-headless-compression-fda-510k.jpg K090949 - SYNTHES (USA) 1.5MM HEADLESS COMPRESSION SCREWS K090949 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jul 2009. https://www.510kdatabase.net/k091494/ 2009-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k091494-flexitime-flow-fda-510k.jpg K091494 - FLEXITIME FLOW K091494 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Jul 2009. https://www.510kdatabase.net/k090954/ 2009-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k090954-atlas-wound-matrix-fda-510k.jpg K090954 - ATLAS WOUND MATRIX K090954 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jul 2009. https://www.510kdatabase.net/k092015/ 2009-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k092015-peri-loc-periarticular-locked-plating-fda-510k.jpg K092015 - PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM K092015 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 2009. https://www.510kdatabase.net/k092179/ 2009-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k092179-aplio-xg-diagnostic-ultrasound-system-fda-510k.jpg K092179 - APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 4.0R001 K092179 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Jul 2009. https://www.510kdatabase.net/k092122/ 2009-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k092122-global-shoulder-steptech-anchor-peg-fda-510k.jpg K092122 - GLOBAL SHOULDER STEPTECH ANCHOR PEG GLENOID K092122 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jul 2009. https://www.510kdatabase.net/k091294/ 2009-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k091294-lateral-column-length-plate-model-fda-510k.jpg K091294 - LATERAL COLUMN LENGTH PLATE, MODEL 824073000-3, LOCKED FUSION PLATE, MODEL 824077010, COMPRESSION FUSION PLATE, K091294 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jul 2009. https://www.510kdatabase.net/k080380/ 2009-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k080380-sas-influenza-a-b-test-fda-510k.jpg K080380 - SAS INFLUENZA A & B TEST K080380 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Jul 2009. https://www.510kdatabase.net/k091028/ 2009-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k091028-omni-5-total-o2-delivery-system-fda-510k.jpg K091028 - OMNI 5 TOTAL O2 DELIVERY SYSTEM K091028 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Jul 2009. https://www.510kdatabase.net/k083113/ 2009-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k083113-acticoat-flex-7-dressing-fda-510k.jpg K083113 - ACTICOAT FLEX 7 DRESSING K083113 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 2009. https://www.510kdatabase.net/k091024/ 2009-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k091024-chromid-mrsa-agar-model-ref-43-841-fda-510k.jpg K091024 - CHROMID MRSA AGAR, MODEL: REF 43 841 K091024 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jul 2009. https://www.510kdatabase.net/k090955/ 2009-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k090955-smith-nephew-rf-cannulate-fda-510k.jpg K090955 - SMITH & NEPHEW RF CANNULATE K090955 is a FDA 510(k) cleared neurology medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 2009. https://www.510kdatabase.net/k083903/ 2009-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k083903-3m-littmann-electronic-stethoscope-fda-510k.jpg K083903 - 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3200 K083903 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: 3M Company. Cleared Jul 2009. https://www.510kdatabase.net/k091442/ 2009-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k091442-cd-horizon-spinal-system-fda-510k.jpg K091442 - CD HORIZON SPINAL SYSTEM K091442 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Jul 2009. https://www.510kdatabase.net/k090857/ 2009-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k090857-valor-ankle-fusion-nail-system-fda-510k.jpg K090857 - VALOR ANKLE FUSION NAIL SYSTEM K090857 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jul 2009. https://www.510kdatabase.net/k090952/ 2009-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k090952-zyfuse-facet-fixation-system-fda-510k.jpg K090952 - ZYFUSE FACET FIXATION SYSTEM K090952 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Jul 2009. https://www.510kdatabase.net/k091751/ 2009-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k091751-depuy-delta-xtend-reverse-shoulder-xlk-fda-510k.jpg K091751 - DEPUY DELTA XTEND REVERSE SHOULDER XLK CUP K091751 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jul 2009. https://www.510kdatabase.net/k091153/ 2009-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k091153-synchron-systems-enzymatic-co2-co2e-fda-510k.jpg K091153 - SYNCHRON SYSTEMS ENZYMATIC CO2 (CO2E) REAGENT, MODEL A60291 K091153 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jul 2009. https://www.510kdatabase.net/k090988/ 2009-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k090988-gmk-total-knee-system-fda-510k.jpg K090988 - GMK TOTAL KNEE SYSTEM K090988 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Jul 2009. https://www.510kdatabase.net/k091689/ 2009-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k091689-synapse-system-40mm-oc-fusion-system-fda-510k.jpg K091689 - SYNAPSE SYSTEM 4.0MM, OC FUSION SYSTEM 4.0MM K091689 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jul 2009. https://www.510kdatabase.net/k091470/ 2009-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k091470-ranasys-ez-negative-pressure-wound-fda-510k.jpg K091470 - RANASYS EZ NEGATIVE PRESSURE WOUND THERAPY SYSTEM, MODEL 66800059 K091470 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 2009. https://www.510kdatabase.net/k091941/ 2009-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k091941-dc-3dc-3t-diagnostic-ultrasound-system-fda-510k.jpg K091941 - DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM K091941 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Jul 2009. https://www.510kdatabase.net/k090541/ 2009-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k090541-elecsys-precicontrol-universal-fda-510k.jpg K090541 - ELECSYS PRECICONTROL UNIVERSAL K090541 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Jul 2009. https://www.510kdatabase.net/k090554/ 2009-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k090554-acuity-mailman-and-strait-trak-guidewire-fda-510k.jpg K090554 - ACUITY MAILMAN AND STRAIT-TRAK GUIDEWIRE K090554 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Jul 2009. https://www.510kdatabase.net/k091377/ 2009-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k091377-bd-flu-syringe-fda-510k.jpg K091377 - BD FLU+ SYRINGE K091377 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson & CO. Cleared Jul 2009. https://www.510kdatabase.net/k091627/ 2009-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k091627-smith-nephew-instrument-trays-fda-510k.jpg K091627 - SMITH & NEPHEW INSTRUMENT TRAYS K091627 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 2009. https://www.510kdatabase.net/k083689/ 2009-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k083689-infusomat-space-volumetric-infusion-fda-510k.jpg K083689 - INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM K083689 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Jul 2009. https://www.510kdatabase.net/k091670/ 2009-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k091670-bd-l-cath-single-and-dual-lument-fda-510k.jpg K091670 - BD L-CATH SINGLE AND DUAL LUMENT CATHETERS, MIDLINE CATHETER K091670 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson & CO. Cleared Jul 2009. https://www.510kdatabase.net/k091816/ 2009-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k091816-ultraflex-esophageal-ng-stent-system-fda-510k.jpg K091816 - ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM K091816 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Jul 2009. https://www.510kdatabase.net/k090565/ 2009-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k090565-ellipse-occipito-cerico-thoracic-fda-510k.jpg K090565 - ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM K090565 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Jun 2009. https://www.510kdatabase.net/k090596/ 2009-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k090596-zimmer-natural-nail-system-stainless-fda-510k.jpg K090596 - ZIMMER NATURAL NAIL SYSTEM STAINLESS STEEL TIBIAL NAIL & STAINLESS PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEM K090596 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jun 2009. https://www.510kdatabase.net/k090884/ 2009-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k090884-perifix-one-pediatric-catheter-20-ga-fda-510k.jpg K090884 - PERIFIX ONE PEDIATRIC CATHETER, 20 GA. & 24 GA. K090884 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Jun 2009. https://www.510kdatabase.net/k091136/ 2009-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k091136-amsco-evolution-medium-steam-fda-510k.jpg K091136 - AMSCO EVOLUTION MEDIUM STEAM STERILIZER, MODEL HC-900 AND HC-1200 K091136 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Jun 2009. https://www.510kdatabase.net/k091658/ 2009-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k091658-ge-innova-solid-state-xray-imager-fda-510k.jpg K091658 - GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODELS INNOVA 4100, 3100, 2100, 3131, 2121 K091658 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Jun 2009. https://www.510kdatabase.net/k083435/ 2009-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k083435-arthrex-univers-ii-shoulder-pegged-fda-510k.jpg K083435 - ARTHREX UNIVERS II SHOULDER PEGGED GLENOID K083435 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jun 2009. https://www.510kdatabase.net/k090877/ 2009-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k090877-proximal-tibia-locking-plate-standard-fda-510k.jpg K090877 - PROXIMAL TIBIA LOCKING PLATE STANDARD AND LARGE, 3.5MM LOW PROFILE AND MULTIDIRECTIONAL SCREWS K090877 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jun 2009. https://www.510kdatabase.net/k091243/ 2009-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k091243-ortholoc-ankle-plating-system-aps-fda-510k.jpg K091243 - ORTHOLOC ANKLE PLATING SYSTEM (APS) K091243 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jun 2009. https://www.510kdatabase.net/k091510/ 2009-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k091510-wallflex-esophageal-fully-covered-fda-510k.jpg K091510 - WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM, MODELS M00516700, M00516710, M00516720, M00516730 K091510 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Jun 2009. https://www.510kdatabase.net/k083895/ 2009-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k083895-codman-isocool-bipolar-forceps-fda-510k.jpg K083895 - CODMAN ISOCOOL BIPOLAR FORCEPS K083895 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Jun 2009. https://www.510kdatabase.net/k090462/ 2009-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k090462-brilliance-dual-energy-option-fda-510k.jpg K090462 - BRILLIANCE DUAL ENERGY OPTION K090462 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Jun 2009. https://www.510kdatabase.net/k091209/ 2009-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k091209-portalvision-advanced-imaging-fda-510k.jpg K091209 - PORTALVISION ADVANCED IMAGING K091209 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Jun 2009. https://www.510kdatabase.net/k080469/ 2009-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k080469-vidas-ca-15-3-assay-fda-510k.jpg K080469 - VIDAS CA 15-3 ASSAY K080469 is a FDA 510(k) cleared immunology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jun 2009. https://www.510kdatabase.net/k082340/ 2009-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k082340-roche-elecsys-folate-iii-roche-elecsys-fda-510k.jpg K082340 - ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELECSYS FOLATE III CALSET, ROCHE ELECSYS K082340 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jun 2009. https://www.510kdatabase.net/k090745/ 2009-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k090745-artis-zee-zeegos-with-sw-vc14-fda-510k.jpg K090745 - ARTIS ZEE / ZEEGOS WITH SW VC14 K090745 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 2009. https://www.510kdatabase.net/k090939/ 2009-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k090939-roche-cfas-dat-qualitative-plus-fda-510k.jpg K090939 - ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190 K090939 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Jun 2009. https://www.510kdatabase.net/k091126/ 2009-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k091126-vitek-2-gram-positive-daptomycin-fda-510k.jpg K091126 - VITEK 2 GRAM POSITIVE DAPTOMYCIN K091126 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jun 2009. https://www.510kdatabase.net/k091492/ 2009-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k091492-modification-to-eclipse-treatment-fda-510k.jpg K091492 - MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM K091492 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Jun 2009. https://www.510kdatabase.net/k090241/ 2009-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k090241-synthes-angular-stable-locking-system-fda-510k.jpg K090241 - SYNTHES ANGULAR STABLE LOCKING SYSTEM (ASLS) K090241 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jun 2009. https://www.510kdatabase.net/k091161/ 2009-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k091161-rejuvenate-monolithic-size-4-hip-stem-fda-510k.jpg K091161 - REJUVENATE MONOLITHIC SIZE 4 HIP STEM K091161 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jun 2009. https://www.510kdatabase.net/k090998/ 2009-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k090998-depuy-pinnacle-100-with-gription-fda-510k.jpg K090998 - DEPUY PINNACLE 100 WITH GRIPTION ACETABULAR CUPS K090998 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jun 2009. https://www.510kdatabase.net/k091527/ 2009-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k091527-advance-35lp-low-profile-pta-balloon-fda-510k.jpg K091527 - ADVANCE 35LP LOW PROFILE PTA BALLOON DILATATION CATHETER K091527 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Jun 2009. https://www.510kdatabase.net/k090680/ 2009-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k090680-heparin-lock-flush-solution-usp-bd-fda-510k.jpg K090680 - HEPARIN LOCK FLUSH SOLUTION, USP BD POSIFLUSH HEPARIN LOCK FLUSH SYRINGE K090680 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson & CO. Cleared Jun 2009. https://www.510kdatabase.net/k091340/ 2009-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k091340-through-the-peg-ttp-jejunal-feeding-fda-510k.jpg K091340 - THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330, M00566340, M00566350 K091340 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Jun 2009. https://www.510kdatabase.net/k090926/ 2009-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k090926-smith-nephew-rail-system-fda-510k.jpg K090926 - SMITH & NEPHEW RAIL SYSTEM K090926 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jun 2009. https://www.510kdatabase.net/k083723/ 2009-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k083723-a6-luer-access-device-fda-510k.jpg K083723 - A6 LUER ACCESS DEVICE K083723 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Jun 2009. https://www.510kdatabase.net/k090971/ 2009-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k090971-bd-probetec-neisseria-gonorrhoeae-gc-fda-510k.jpg K090971 - BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY K090971 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Jun 2009. https://www.510kdatabase.net/k091370/ 2009-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k091370-radia-steerable-diagnostic-catheter-fda-510k.jpg K091370 - RADIA STEERABLE DIAGNOSTIC CATHETER K091370 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jun 2009. https://www.510kdatabase.net/k090675/ 2009-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k090675-smith-nephew-inc-vlp-foot-plating-fda-510k.jpg K090675 - SMITH & NEPHEW, INC. VLP FOOT PLATING, SCREW SYSTEM AND ACCESSORIES K090675 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jun 2009. https://www.510kdatabase.net/k090656/ 2009-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k090656-intertan-chs-limited-collapse-set-screw-fda-510k.jpg K090656 - INTERTAN CHS LIMITED COLLAPSE SET SCREW K090656 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jun 2009. https://www.510kdatabase.net/k082166/ 2009-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k082166-mastergraft-strip-fda-510k.jpg K082166 - MASTERGRAFT STRIP K082166 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Jun 2009. https://www.510kdatabase.net/k090209/ 2009-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k090209-hemosil-liquid-heparin-heparin-fda-510k.jpg K090209 - HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS K090209 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jun 2009. https://www.510kdatabase.net/k090776/ 2009-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k090776-megapulse-laser-system-and-fibers-fda-510k.jpg K090776 - MEGAPULSE LASER SYSTEM AND FIBERS K090776 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Jun 2009. https://www.510kdatabase.net/k090824/ 2009-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k090824-bd-probetec-chlamydia-trachomatis-ct-fda-510k.jpg K090824 - BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY K090824 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Jun 2009. https://www.510kdatabase.net/k091346/ 2009-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k091346-codman-hakim-micro-ii-valve-fda-510k.jpg K091346 - CODMAN HAKIM MICRO II VALVE K091346 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Jun 2009. https://www.510kdatabase.net/k091069/ 2009-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k091069-medacta-bone-screws-evolis-and-versafit-fda-510k.jpg K091069 - MEDACTA BONE SCREWS - EVOLIS AND VERSAFIT K091069 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Jun 2009. https://www.510kdatabase.net/k083598/ 2009-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k083598-karl-storz-voice1-scb-r-ui-speech-fda-510k.jpg K083598 - KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATION K083598 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared May 2009. https://www.510kdatabase.net/k091329/ 2009-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k091329-pinnacle-destination-peripheral-fda-510k.jpg K091329 - PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH K091329 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared May 2009. https://www.510kdatabase.net/k090528/ 2009-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k090528-duet-long-term-hemodialysis-catheter-fda-510k.jpg K090528 - DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM, DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM CATHETER REPAIR KIT K090528 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 2009. https://www.510kdatabase.net/k090420/ 2009-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k090420-smith-nephew-pigalileo-screw-targeting-fda-510k.jpg K090420 - SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM V 1.0 K090420 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared May 2009. https://www.510kdatabase.net/k090588/ 2009-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k090588-power-processor-sample-processing-fda-510k.jpg K090588 - POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTION MODULE, MODEL: 4210 K090588 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared May 2009. https://www.510kdatabase.net/k090827/ 2009-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k090827-bd-probetec-neisseria-gonorrhoeae-gc-fda-510k.jpg K090827 - BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY K090827 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared May 2009. https://www.510kdatabase.net/k091195/ 2009-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k091195-philips-mx-16-slice-ct-system-phase11-fda-510k.jpg K091195 - PHILIPS MX 16 SLICE CT SYSTEM PHASE11, MODEL 9896 056 56511 K091195 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared May 2009. https://www.510kdatabase.net/k090330/ 2009-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k090330-dimension-vista-enzymatic-creatinine-fda-510k.jpg K090330 - DIMENSION VISTA ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE, AND ENZYMATIC CREATININE CALIBRATOR, MODELS K1270, KC270 K090330 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared May 2009. https://www.510kdatabase.net/k091373/ 2009-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k091373-syngo-trued-fda-510k.jpg K091373 - SYNGO TRUED K091373 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 2009. https://www.510kdatabase.net/k083327/ 2009-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k083327-syngocirculation-dynamicpet-version-10-fda-510k.jpg K083327 - SYNGOCIRCULATION DYNAMICPET, VERSION 1.0 K083327 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 2009. https://www.510kdatabase.net/k090390/ 2009-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k090390-cd-horizon-spinal-system-fda-510k.jpg K090390 - CD HORIZON SPINAL SYSTEM K090390 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared May 2009. https://www.510kdatabase.net/k091112/ 2009-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k091112-respironics-sleepeasy-cpap-system-fda-510k.jpg K091112 - RESPIRONICS SLEEPEASY CPAP SYSTEM K091112 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared May 2009. https://www.510kdatabase.net/k091286/ 2009-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k091286-syngo-us-workplace-fda-510k.jpg K091286 - SYNGO US WORKPLACE K091286 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 2009. https://www.510kdatabase.net/k091295/ 2009-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k091295-aplio-xg-diagnostic-ultrasound-system-fda-510k.jpg K091295 - APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM MODEL SSA-790A VERSION 4.0 K091295 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared May 2009. https://www.510kdatabase.net/k082060/ 2009-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k082060-cranial-image-guided-surgery-system-fda-510k.jpg K082060 - CRANIAL IMAGE GUIDED SURGERY SYSTEM K082060 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared May 2009. https://www.510kdatabase.net/k090683/ 2009-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k090683-syngo-rt-therapist-connect-fda-510k.jpg K090683 - SYNGO RT THERAPIST CONNECT K090683 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 2009. https://www.510kdatabase.net/k090692/ 2009-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k090692-ortholoc-2024-plate-system-fda-510k.jpg K090692 - ORTHOLOC 2.0/2.4 PLATE SYSTEM K090692 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared May 2009. https://www.510kdatabase.net/k082497/ 2009-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k082497-intuitive-surgical-endowrist-one-hot-fda-510k.jpg K082497 - INTUITIVE SURGICAL ENDOWRIST ONE HOT SHEARS INSTRUMENT K082497 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared May 2009. https://www.510kdatabase.net/k090311/ 2009-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k090311-elecsys-rubella-igg-calcheck-fda-510k.jpg K090311 - ELECSYS RUBELLA IGG CALCHECK K090311 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Diagnostics. Cleared May 2009. https://www.510kdatabase.net/k090371/ 2009-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k090371-vis-u-all-low-temperature-tyvek-fda-510k.jpg K090371 - VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR V-PRO 1 STERILIZATION SYSTEM K090371 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared May 2009. https://www.510kdatabase.net/k082649/ 2009-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k082649-synthes-90-degree-screwdriver-fda-510k.jpg K082649 - SYNTHES 90 DEGREE SCREWDRIVER K082649 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Apr 2009. https://www.510kdatabase.net/k090569/ 2009-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k090569-modification-to-attest-rapid-readout-fda-510k.jpg K090569 - MODIFICATION TO: ATTEST RAPID READOUT BIOLOGICAL INDICATOR, MODE 1292 K090569 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Apr 2009. https://www.510kdatabase.net/k090038/ 2009-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k090038-syngo-brevis-fda-510k.jpg K090038 - SYNGO BREVIS K090038 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 2009. https://www.510kdatabase.net/k090822/ 2009-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k090822-advance-14rx-rapid-exchange-pta-fda-510k.jpg K090822 - ADVANCE 14RX RAPID EXCHANGE PTA BALLOON CATHETER K090822 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Apr 2009. https://www.510kdatabase.net/k090905/ 2009-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k090905-addease-20mm-binary-connector-with-17-fda-510k.jpg K090905 - ADDEASE 20MM BINARY CONNECTOR WITH 17 GA. NEEDLE K090905 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Apr 2009. https://www.510kdatabase.net/k083374/ 2009-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k083374-wallflex-biliary-rx-partially-covered-fda-510k.jpg K083374 - WALLFLEX BILIARY RX PARTIALLY-COVERED STENT SYSTEM K083374 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Apr 2009. https://www.510kdatabase.net/k090134/ 2009-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k090134-intravenous-power-injector-extension-set-fda-510k.jpg K090134 - INTRAVENOUS POWER INJECTOR EXTENSION SET K090134 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 2009. https://www.510kdatabase.net/k090764/ 2009-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k090764-novation-cfs-press-fit-and-cemented-fda-510k.jpg K090764 - NOVATION CFS PRESS-FIT AND CEMENTED STEMS K090764 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Apr 2009. https://www.510kdatabase.net/k090714/ 2009-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k090714-vertex-reconstruction-system-vertex-fda-510k.jpg K090714 - VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM K090714 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Apr 2009. https://www.510kdatabase.net/k082997/ 2009-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k082997-terumo-hybria-closed-system-safety-iv-fda-510k.jpg K082997 - TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER K082997 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terumo Medical Corp.. Cleared Apr 2009. https://www.510kdatabase.net/k083623/ 2009-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k083623-carpentier-mccarthy-adams-imr-etlogix-fda-510k.jpg K083623 - CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNULOPLASTY RING, MODEL 4100 K083623 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Apr 2009. https://www.510kdatabase.net/k090519/ 2009-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k090519-vanish-varnish-5-sodium-fluoride-fda-510k.jpg K090519 - VANISH VARNISH, 5% SODIUM FLUORIDE VARNISH, MODEL 12245, VANISH VARNISH, 5% FLUORIDE VARNISH, MODEL 12247 K090519 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Apr 2009. https://www.510kdatabase.net/k090702/ 2009-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k090702-modification-to-dash-2500-patient-fda-510k.jpg K090702 - MODIFICATION TO DASH 2500 PATIENT MONITOR K090702 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Apr 2009. https://www.510kdatabase.net/k090912/ 2009-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k090912-digital-ultrasonic-diagnostic-imaging-fda-510k.jpg K090912 - DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-6900 K090912 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Apr 2009. https://www.510kdatabase.net/k090148/ 2009-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k090148-proguide-chronic-dialysis-catheter-fda-510k.jpg K090148 - PROGUIDE CHRONIC DIALYSIS CATHETER K090148 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Apr 2009. https://www.510kdatabase.net/k080561/ 2009-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k080561-vidas-ca-125-ii-assay-fda-510k.jpg K080561 - VIDAS CA 125 II ASSAY K080561 is a FDA 510(k) cleared immunology medical device. Manufacturer: bioMerieux, Inc.. Cleared Apr 2009. https://www.510kdatabase.net/k083191/ 2009-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k083191-detlogix-annuloplasty-ring-model-5100-fda-510k.jpg K083191 - DETLOGIX ANNULOPLASTY RING, MODEL: 5100 K083191 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Apr 2009. https://www.510kdatabase.net/k082251/ 2009-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k082251-synchron-systems-microalbumin-ma-fda-510k.jpg K082251 - SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100 K082251 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Apr 2009. https://www.510kdatabase.net/k083007/ 2009-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k083007-prowick-fda-510k.jpg K083007 - PROWICK K083007 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Arthrex, Inc.. Cleared Apr 2009. https://www.510kdatabase.net/k083483/ 2009-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k083483-brainlab-hip-unlimited-ci-hip-unlimited-fda-510k.jpg K083483 - BRAINLAB HIP UNLIMITED, CI HIP UNLIMITED K083483 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Brainlab AG. Cleared Apr 2009. https://www.510kdatabase.net/k083116/ 2009-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k083116-versafit-cup-double-mobility-system-fda-510k.jpg K083116 - VERSAFIT CUP DOUBLE MOBILITY SYSTEM K083116 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Apr 2009. https://www.510kdatabase.net/k083627/ 2009-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k083627-wallflex-biliary-rx-fully-covered-fda-510k.jpg K083627 - WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510, M00570520, M00570530, M00570540 K083627 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Apr 2009. https://www.510kdatabase.net/k083809/ 2009-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k083809-creatinine-fda-510k.jpg K083809 - CREATININE K083809 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Apr 2009. https://www.510kdatabase.net/k090624/ 2009-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k090624-cook-mreye-embolization-coils-fda-510k.jpg K090624 - COOK MREYE EMBOLIZATION COILS K090624 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Apr 2009. https://www.510kdatabase.net/k083310/ 2009-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k083310-spine-trauma-ict-fda-510k.jpg K083310 - SPINE & TRAUMA ICT K083310 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Brainlab AG. Cleared Apr 2009. https://www.510kdatabase.net/k083524/ 2009-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k083524-syngo-dual-energy-with-extended-fda-510k.jpg K083524 - SYNGO DUAL ENERGY WITH EXTENDED FUNATIONALLY K083524 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 2009. https://www.510kdatabase.net/k090047/ 2009-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k090047-synthes-usa-15mm-mini-fragment-lcp-fda-510k.jpg K090047 - SYNTHES (USA) 1.5MM MINI FRAGMENT LCP SYSTEM K090047 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Apr 2009. https://www.510kdatabase.net/k083114/ 2009-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k083114-acuson-p50-ultrasound-system-fda-510k.jpg K083114 - ACUSON P50 ULTRASOUND SYSTEM K083114 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2009. https://www.510kdatabase.net/k090403/ 2009-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k090403-autospect-fda-510k.jpg K090403 - AUTOSPECT K090403 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Mar 2009. https://www.510kdatabase.net/k090492/ 2009-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k090492-15mm-small-locking-plate-15mm-non-fda-510k.jpg K090492 - 1.5MM SMALL LOCKING PLATE, 1.5MM NON-LOCKING AND LOCKING SCREWS K090492 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Mar 2009. https://www.510kdatabase.net/k080852/ 2009-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k080852-ksea-electronic-co2-endoflator-lc-fda-510k.jpg K080852 - KSEA ELECTRONIC CO2 ENDOFLATOR LC, MODEL 26430320-1 K080852 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Mar 2009. https://www.510kdatabase.net/k083266/ 2009-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k083266-gore-bio-a-fistula-plug-fda-510k.jpg K083266 - GORE BIO-A FISTULA PLUG K083266 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Mar 2009. https://www.510kdatabase.net/k090512/ 2009-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k090512-powerport-duo-mri-implanted-port-with-fda-510k.jpg K090512 - POWERPORT DUO M.R.I. IMPLANTED PORT WITH 9.5 FR. DUAL LUMEN CHRONOFLEX POLYURETHANE CATHETER K090512 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 2009. https://www.510kdatabase.net/k083389/ 2009-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k083389-coalition-spacer-fda-510k.jpg K083389 - COALITION SPACER K083389 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Mar 2009. https://www.510kdatabase.net/k090659/ 2009-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k090659-attain-command-6250-left-heart-fda-510k.jpg K090659 - ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND GUIDE CATHETERS FOR LEFT HEART DELIVERY K090659 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Mar 2009. https://www.510kdatabase.net/k082558/ 2009-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k082558-comfortlite-nasal-mask-fda-510k.jpg K082558 - COMFORTLITE NASAL MASK K082558 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Mar 2009. https://www.510kdatabase.net/k083750/ 2009-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k083750-capnostat-capnoflex-co2-system-fda-510k.jpg K083750 - CAPNOSTAT / CAPNOFLEX CO2 SYSTEM K083750 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Mar 2009. https://www.510kdatabase.net/k083789/ 2009-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k083789-ace-fischer-external-fixation-system-fda-510k.jpg K083789 - ACE FISCHER EXTERNAL FIXATION SYSTEM K083789 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Mar 2009. https://www.510kdatabase.net/k083852/ 2009-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k083852-biograph-16-true-point-systems-fda-510k.jpg K083852 - BIOGRAPH 16 TRUE POINT SYSTEMS K083852 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2009. https://www.510kdatabase.net/k083843/ 2009-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k083843-locking-anatomic-composite-plating-fda-510k.jpg K083843 - LOCKING ANATOMIC & COMPOSITE PLATING SYSTEM K083843 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Mar 2009. https://www.510kdatabase.net/k090136/ 2009-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k090136-steris-cmax-xlt-surgical-table-fda-510k.jpg K090136 - STERIS CMAX XLT SURGICAL TABLE K090136 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: STERIS Corporation. Cleared Mar 2009. https://www.510kdatabase.net/k083675/ 2009-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k083675-power-trialysis-triple-lumen-acute-fda-510k.jpg K083675 - POWER-TRIALYSIS TRIPLE LUMEN ACUTE DIALYSIS CATHETER K083675 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 2009. https://www.510kdatabase.net/k081615/ 2009-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k081615-olympus-cea-carcinoembryonic-antigen-fda-510k.jpg K081615 - OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN K081615 is a FDA 510(k) cleared immunology medical device. Manufacturer: Olympus America, Inc.. Cleared Mar 2009. https://www.510kdatabase.net/k083444/ 2009-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k083444-c-reactive-protein-latex-fda-510k.jpg K083444 - C-REACTIVE PROTEIN (LATEX) K083444 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Mar 2009. https://www.510kdatabase.net/k090547/ 2009-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k090547-ultraclip-ii-us-wing-and-coil-models-fda-510k.jpg K090547 - ULTRACLIP II US WING AND COIL, MODELS: 862017U, 864017U K090547 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 2009. https://www.510kdatabase.net/k090562/ 2009-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k090562-smith-nephew-instrument-trays-fda-510k.jpg K090562 - SMITH & NEPHEW INSTRUMENT TRAYS K090562 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Mar 2009. https://www.510kdatabase.net/k090141/ 2009-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k090141-prontosan-antimicrobial-wound-gel-fda-510k.jpg K090141 - PRONTOSAN ANTIMICROBIAL WOUND GEL K090141 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Mar 2009. https://www.510kdatabase.net/k082346/ 2009-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k082346-vitek-2-gram-negative-doripenem-fda-510k.jpg K082346 - VITEK 2 GRAM NEGATIVE DORIPENEM K082346 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Mar 2009. https://www.510kdatabase.net/k090514/ 2009-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k090514-verify-self-contained-biological-fda-510k.jpg K090514 - VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR FOR VAPORIZED (VH2O2) STERILIZATION PROCESSES K090514 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Mar 2009. https://www.510kdatabase.net/k083518/ 2009-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k083518-acl-acustar-hemosil-acustar-d-dimer-fda-510k.jpg K083518 - ACL ACUSTAR, HEMOSIL ACUSTAR D-DIMER, HEMOSIL ACUSTAR D-DIMER CONTROLS K083518 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Mar 2009. https://www.510kdatabase.net/k083388/ 2009-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k083388-synthes-matrixorthognathis-fixation-fda-510k.jpg K083388 - SYNTHES MATRIXORTHOGNATHIS FIXATION SYSTEM K083388 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Mar 2009. https://www.510kdatabase.net/k083762/ 2009-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k083762-biolox-delta-ceramic-femoral-heads-fda-510k.jpg K083762 - BIOLOX DELTA CERAMIC FEMORAL HEADS K083762 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Mar 2009. https://www.510kdatabase.net/k090313/ 2009-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k090313-pigalileo-tkr-base-v23-and-cas-v41-fda-510k.jpg K090313 - PIGALILEO TKR BASE V2.3 AND CAS V4.1 K090313 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Mar 2009. https://www.510kdatabase.net/k090374/ 2009-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k090374-sterile-dvr-anatomic-plates-various-fda-510k.jpg K090374 - STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 2.5MM THREADED AND SMOOTH PEGS, MODEL(S K090374 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Mar 2009. https://www.510kdatabase.net/k083339/ 2009-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k083339-dimension-rxl-max-with-advia-modular-fda-510k.jpg K083339 - DIMENSION RXL MAX WITH ADVIA MODULAR AUTOMATION SYSTEM (AMAS) K083339 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Mar 2009. https://www.510kdatabase.net/k082924/ 2009-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k082924-dynasty-porous-acetabular-shell-fda-510k.jpg K082924 - DYNASTY POROUS ACETABULAR SHELL, DYNASTY POLYETHYLENE ACETABULAR LINER, DYNASTY METAL ACETABULAR LINER K082924 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Mar 2009. https://www.510kdatabase.net/k083558/ 2009-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k083558-medacta-total-hip-prosthesis-system-fda-510k.jpg K083558 - MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA C K083558 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Mar 2009. https://www.510kdatabase.net/k083642/ 2009-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k083642-depuy-pinnacle-metal-on-metal-fda-510k.jpg K083642 - DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS K083642 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Mar 2009. https://www.510kdatabase.net/k083694/ 2009-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k083694-synthes-usa-24-mm-va-lcp-two-column-fda-510k.jpg K083694 - SYNTHES (USA) 2.4 MM VA-LCP TWO COLUMN VOLAR DISTAL RADIUS PLATES K083694 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Mar 2009. https://www.510kdatabase.net/k090084/ 2009-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k090084-elation-endovenous-laser-procedure-kit-fda-510k.jpg K090084 - ELATION ENDOVENOUS LASER PROCEDURE KIT UNIVERSAL FLUID DISPENSING SYRINGE K090084 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Mar 2009. https://www.510kdatabase.net/k083573/ 2009-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k083573-synthes-usa-35mm-locking-attachment-fda-510k.jpg K083573 - SYNTHES (USA) 3.5MM LOCKING ATTACHMENT PLATES K083573 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Mar 2009. https://www.510kdatabase.net/k090348/ 2009-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k090348-codman-bactiseal-evd-catheter-set-fda-510k.jpg K090348 - CODMAN BACTISEAL EVD CATHETER SET, CODMAN BACTISEAL CLEAR EVD CATHETER SET K090348 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Mar 2009. https://www.510kdatabase.net/k083566/ 2009-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k083566-r3-constrained-liner-constrained-liner-fda-510k.jpg K083566 - R3 CONSTRAINED LINER, CONSTRAINED LINER K083566 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Mar 2009. https://www.510kdatabase.net/k083456/ 2009-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k083456-nihon-kohden-co2-sensor-kit-model-tg-fda-510k.jpg K083456 - NIHON KOHDEN CO2 SENSOR KIT, MODEL TG-970P K083456 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Mar 2009. https://www.510kdatabase.net/k082638/ 2009-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k082638-advia-centaur-system-with-streamlab-fda-510k.jpg K082638 - ADVIA CENTAUR SYSTEM WITH STREAMLAB ANALYTICAL WORKCELL K082638 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Feb 2009. https://www.510kdatabase.net/k083654/ 2009-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k083654-zimmer-universal-locking-system-27-mm-fda-510k.jpg K083654 - ZIMMER UNIVERSAL LOCKING SYSTEM 2.7 MM LOCKING PLATES AND SCREWS ( TIVANIUM TI-6A1-4V ALLOY, CP GRADE TITANIUM) K083654 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Feb 2009. https://www.510kdatabase.net/k083375/ 2009-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k083375-renasys-go-negative-pressure-wound-fda-510k.jpg K083375 - RENASYS GO NEGATIVE PRESSURE WOUND THERAPY K083375 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Feb 2009. https://www.510kdatabase.net/k073439/ 2009-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k073439-transition-stabilization-system-fda-510k.jpg K073439 - TRANSITION STABILIZATION SYSTEM K073439 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Feb 2009. https://www.510kdatabase.net/k080481/ 2009-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k080481-access-immunoassay-systems-myoglobin-fda-510k.jpg K080481 - ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS K080481 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Feb 2009. https://www.510kdatabase.net/k081479/ 2009-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k081479-advance-a-class-tibial-insert-fda-510k.jpg K081479 - ADVANCE A-CLASS TIBIAL INSERT K081479 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Feb 2009. https://www.510kdatabase.net/k083565/ 2009-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k083565-pigalileo-total-hip-replacement-thr-fda-510k.jpg K083565 - PIGALILEO TOTAL HIP REPLACEMENT (THR) SOFTWARE APPLICATION V3.0 K083565 is a FDA 510(k) cleared neurology medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Feb 2009. https://www.510kdatabase.net/k090133/ 2009-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k090133-connex-gastrointestinal-suture-anchor-fda-510k.jpg K090133 - CONNEX GASTROINTESTINAL SUTURE ANCHOR, MODEL GIAS K090133 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook, Inc.. Cleared Feb 2009. https://www.510kdatabase.net/k082775/ 2009-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k082775-prescision-option-fda-510k.jpg K082775 - PRESCISION OPTION K082775 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 2009. https://www.510kdatabase.net/k083497/ 2009-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k083497-zimmer-natural-nail-system-piriformis-fda-510k.jpg K083497 - ZIMMER NATURAL NAIL SYSTEM PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEMORAL NAILS K083497 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Feb 2009. https://www.510kdatabase.net/k090276/ 2009-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k090276-acuson-x300-diagnostic-ultrasound-system-fda-510k.jpg K090276 - ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM K090276 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 2009. https://www.510kdatabase.net/k081137/ 2009-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k081137-intuitive-surgical-da-vinci-si-fda-510k.jpg K081137 - INTUITIVE SURGICAL DA VINCI SI SURGICAL SYSTEM: MODEL IS3000 K081137 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Feb 2009. https://www.510kdatabase.net/k082300/ 2009-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k082300-anatomic-locking-plating-system-fda-510k.jpg K082300 - ANATOMIC LOCKING PLATING SYSTEM K082300 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Feb 2009. https://www.510kdatabase.net/k083383/ 2009-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k083383-vitek-2-gram-positive-erythromycin-for-fda-510k.jpg K083383 - VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE K083383 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Feb 2009. https://www.510kdatabase.net/k083639/ 2009-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k083639-muse-cardiology-information-system-fda-510k.jpg K083639 - MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE K083639 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Feb 2009. https://www.510kdatabase.net/k083503/ 2009-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k083503-drad30003radrex-i-fda-510k.jpg K083503 - DRAD30003/RADREX-I K083503 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Feb 2009. https://www.510kdatabase.net/k083655/ 2009-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k083655-elecsys-toxo-igg-calcheck-fda-510k.jpg K083655 - ELECSYS TOXO IGG CALCHECK K083655 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Diagnostics. Cleared Feb 2009. https://www.510kdatabase.net/k090102/ 2009-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k090102-niagara-niagara-slim-cath-and-brevia-fda-510k.jpg K090102 - NIAGARA, NIAGARA SLIM-CATH, AND BREVIA SHORT-TERM CURVED EXTENSION HEMODIALYSIS CATHETERS K090102 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Feb 2009. https://www.510kdatabase.net/k090103/ 2009-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k090103-100kgy-e-poly-acetabular-liners-fda-510k.jpg K090103 - 100KGY E-POLY ACETABULAR LINERS- ADDITIONAL PROFILES: +3 MAXROM AND +3 HI-WALL K090103 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Feb 2009. https://www.510kdatabase.net/k090101/ 2009-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k090101-equistream-long-term-hemodialysis-fda-510k.jpg K090101 - EQUISTREAM LONG-TERM HEMODIALYSIS CATHETERS K090101 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Feb 2009. https://www.510kdatabase.net/k082371/ 2009-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k082371-smith-nephew-sl-plus-mia-standard-and-fda-510k.jpg K082371 - SMITH & NEPHEW SL-PLUS MIA STANDARD AND LATERAL FEMORAL HIP STEM K082371 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Feb 2009. https://www.510kdatabase.net/k082918/ 2009-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k082918-mastergraft-resorbable-ceramic-granules-fda-510k.jpg K082918 - MASTERGRAFT RESORBABLE CERAMIC GRANULES K082918 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Feb 2009. https://www.510kdatabase.net/k083107/ 2009-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k083107-modification-to-depuy-neuflex-pip-finger-fda-510k.jpg K083107 - MODIFICATION TO DEPUY NEUFLEX PIP FINGER K083107 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Feb 2009. https://www.510kdatabase.net/k082873/ 2009-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k082873-medtronic-angiographic-guide-wires-fda-510k.jpg K082873 - MEDTRONIC ANGIOGRAPHIC GUIDE WIRES K082873 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Feb 2009. https://www.510kdatabase.net/k083422/ 2009-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k083422-6f-taiga-guiding-catheter-fda-510k.jpg K083422 - 6F TAIGA GUIDING CATHETER K083422 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Feb 2009. https://www.510kdatabase.net/k083442/ 2009-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k083442-corridor-fixation-system-fda-510k.jpg K083442 - CORRIDOR FIXATION SYSTEM K083442 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Feb 2009. https://www.510kdatabase.net/k090040/ 2009-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k090040-radifocus-glidecath-or-radifocus-fda-510k.jpg K090040 - RADIFOCUS GLIDECATH (OR RADIFOCUS GLIDECATH XP) K090040 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Feb 2009. https://www.510kdatabase.net/k090158/ 2009-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k090158-aplio-artida-v20-ssh-880cv-fda-510k.jpg K090158 - APLIO ARTIDA V2.0 SSH-880CV K090158 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Feb 2009. https://www.510kdatabase.net/k083439/ 2009-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k083439-synthes-epoca-shoulder-prosthesis-system-fda-510k.jpg K083439 - SYNTHES EPOCA SHOULDER PROSTHESIS SYSTEM K083439 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Feb 2009. https://www.510kdatabase.net/k081495/ 2009-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k081495-cell-dyn-emerald-system-fda-510k.jpg K081495 - CELL-DYN EMERALD SYSTEM K081495 is a FDA 510(k) cleared hematology medical device. Manufacturer: Abbott Laboratories. Cleared Feb 2009. https://www.510kdatabase.net/k083300/ 2009-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k083300-gore-flow-reversal-system-fda-510k.jpg K083300 - GORE FLOW REVERSAL SYSTEM K083300 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Feb 2009. https://www.510kdatabase.net/k083523/ 2009-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k083523-monarch-compak-inflation-syringe-and-fda-510k.jpg K083523 - MONARCH COMPAK INFLATION SYRINGE AND UNIVERSAL FLUID DISPENSING SYRINGE K083523 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Feb 2009. https://www.510kdatabase.net/k090170/ 2009-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k090170-spyscope-access-and-delivery-catheter-fda-510k.jpg K090170 - SPYSCOPE ACCESS AND DELIVERY CATHETER K090170 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Feb 2009. https://www.510kdatabase.net/k081576/ 2009-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k081576-blazer-dx-20-diagnostic-catheter-fda-510k.jpg K081576 - BLAZER DX-20 DIAGNOSTIC CATHETER K081576 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Feb 2009. https://www.510kdatabase.net/k082162/ 2009-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k082162-coulter-body-fluid-control-fda-510k.jpg K082162 - COULTER BODY FLUID CONTROL K082162 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Feb 2009. https://www.510kdatabase.net/k083373/ 2009-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k083373-immulite-2000-free-t4-fda-510k.jpg K083373 - IMMULITE 2000 FREE T4 K083373 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Feb 2009. https://www.510kdatabase.net/k082852/ 2009-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k082852-bd-phoenix-automated-microbiology-fda-510k.jpg K082852 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN (GP) 4-128 UG/ML K082852 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Jan 2009. https://www.510kdatabase.net/k083528/ 2009-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k083528-smith-nephew-bipolar-adapter-cable-fda-510k.jpg K083528 - SMITH & NEPHEW BIPOLAR ADAPTER CABLE, MODEL 72200022 K083528 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jan 2009. https://www.510kdatabase.net/k082810/ 2009-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k082810-arthrex-bio-composite-suture-anchors-fda-510k.jpg K082810 - ARTHREX BIO-COMPOSITE SUTURE ANCHORS: ARTHREX BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK AND BIO-COMPOSITE CORKSCREW K082810 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jan 2009. https://www.510kdatabase.net/k083470/ 2009-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k083470-carpentier-edwards-physio-ii-fda-510k.jpg K083470 - CARPENTIER- EDWARDS PHYSIO II ANNULOPLASTY, MODEL 5200 K083470 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Jan 2009. https://www.510kdatabase.net/k081822/ 2009-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k081822-coulter-6c-cell-control-models-628027-fda-510k.jpg K081822 - COULTER 6C CELL CONTROL, MODELS 628027 & A59925 K081822 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jan 2009. https://www.510kdatabase.net/k081193/ 2009-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k081193-cobas-integra-400800-bilirubin-total-fda-510k.jpg K081193 - COBAS INTEGRA 400/800 BILIRUBIN TOTAL K081193 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Jan 2009. https://www.510kdatabase.net/k081641/ 2009-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k081641-coulter-lin-x-linearity-control-fda-510k.jpg K081641 - COULTER LIN-X LINEARITY CONTROL K081641 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jan 2009. https://www.510kdatabase.net/k082728/ 2009-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k082728-vertex-recontruction-system-vertex-fda-510k.jpg K082728 - VERTEX RECONTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM K082728 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Jan 2009. https://www.510kdatabase.net/k082996/ 2009-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k082996-biolox-delta-option-ceramic-heads-fda-510k.jpg K082996 - BIOLOX DELTA OPTION CERAMIC HEADS K082996 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jan 2009. https://www.510kdatabase.net/k083150/ 2009-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k083150-g-force-tenodesis-screw-fda-510k.jpg K083150 - G-FORCE TENODESIS SCREW K083150 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jan 2009. https://www.510kdatabase.net/k083839/ 2009-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k083839-avaulta-solo-synthetic-support-system-fda-510k.jpg K083839 - AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM K083839 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 2009. https://www.510kdatabase.net/k083872/ 2009-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k083872-imns-medacta-navigation-system-fda-510k.jpg K083872 - IMNS MEDACTA NAVIGATION SYSTEM K083872 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Jan 2009. https://www.510kdatabase.net/k083025/ 2009-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k083025-synthes-45-mm-va-lcp-curved-condylar-fda-510k.jpg K083025 - SYNTHES 4.5 MM VA-LCP CURVED CONDYLAR SYSTEM K083025 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jan 2009. https://www.510kdatabase.net/k083149/ 2009-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k083149-arterial-health-package-ahp-software-fda-510k.jpg K083149 - ARTERIAL HEALTH PACKAGE (AHP) SOFTWARE K083149 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 2009. https://www.510kdatabase.net/k083166/ 2009-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k083166-specialty-coils-for-the-magnetom-essenza-fda-510k.jpg K083166 - SPECIALTY COILS FOR THE MAGNETOM ESSENZA K083166 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 2009. https://www.510kdatabase.net/k082917/ 2009-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k082917-mastergraft-resorbable-ceramic-granules-fda-510k.jpg K082917 - MASTERGRAFT RESORBABLE CERAMIC GRANULES K082917 is a FDA 510(k) cleared dental medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Jan 2009. https://www.510kdatabase.net/k083416/ 2009-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k083416-revolve-stabilization-system-fda-510k.jpg K083416 - REVOLVE STABILIZATION SYSTEM K083416 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Jan 2009. https://www.510kdatabase.net/k071754/ 2009-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k071754-neo-vagina-surgery-set-and-accessories-fda-510k.jpg K071754 - NEO-VAGINA SURGERY SET AND ACCESSORIES K071754 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jan 2009. https://www.510kdatabase.net/k073618/ 2009-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k073618-verify-sirius-biological-indicator-fda-510k.jpg K073618 - VERIFY SIRIUS BIOLOGICAL INDICATOR CHALLENGE PACK K073618 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Jan 2009. https://www.510kdatabase.net/k083032/ 2009-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k083032-peri-loc-bone-plating-and-screw-system-fda-510k.jpg K083032 - PERI-LOC BONE PLATING AND SCREW SYSTEM K083032 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jan 2009. https://www.510kdatabase.net/k082396/ 2009-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k082396-davol-absorbable-fastener-system-model-fda-510k.jpg K082396 - DAVOL ABSORBABLE FASTENER SYSTEM, MODEL (S) 0113080,0113081, 0113082, 0113084, 0113086, 0113087 K082396 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 2009. https://www.510kdatabase.net/k082435/ 2008-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k082435-amsco-evolution-medium-steam-sterilizer-fda-510k.jpg K082435 - AMSCO EVOLUTION MEDIUM STEAM STERILIZER K082435 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Dec 2008. https://www.510kdatabase.net/k082613/ 2008-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k082613-merit-microcatheter-fda-510k.jpg K082613 - MERIT MICROCATHETER K082613 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Dec 2008. https://www.510kdatabase.net/k082999/ 2008-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k082999-arthrex-meniscal-dart-arthrex-meniscal-fda-510k.jpg K082999 - ARTHREX MENISCAL DART, ARTHREX MENISCAL DARTSTICK, ARTHREX CHONDRAL DART K082999 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Dec 2008. https://www.510kdatabase.net/k083213/ 2008-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k083213-synthes-27-mm35-mm-lcp-distal-fibula-fda-510k.jpg K083213 - SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES K083213 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Dec 2008. https://www.510kdatabase.net/k082792/ 2008-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k082792-medacta-total-hip-prosthesis-system-fda-510k.jpg K082792 - MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA H AND R FEMORAL STEMS K082792 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Dec 2008. https://www.510kdatabase.net/k082892/ 2008-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k082892-rejuvenate-monolithic-hip-system-fda-510k.jpg K082892 - REJUVENATE MONOLITHIC HIP SYSTEM K082892 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Dec 2008. https://www.510kdatabase.net/k083026/ 2008-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k083026-clydesdale-spinal-system-fda-510k.jpg K083026 - CLYDESDALE SPINAL SYSTEM K083026 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Dec 2008. https://www.510kdatabase.net/k083232/ 2008-12-24 monthly 0.5 https://www.510kdatabase.net/og-image/k083232-modification-tomicrofuse-bone-void-fda-510k.jpg K083232 - MODIFICATION TO:MICROFUSE BONE VOID FILLER K083232 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Dec 2008. https://www.510kdatabase.net/k083271/ 2008-12-24 monthly 0.5 https://www.510kdatabase.net/og-image/k083271-bsm-2300-bsm6000-with-cgs-9001-series-fda-510k.jpg K083271 - BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSORY K083271 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Dec 2008. https://www.510kdatabase.net/k083572/ 2008-12-24 monthly 0.5 https://www.510kdatabase.net/og-image/k083572-bd-bactec-plus-aerobicf-culture-vials-fda-510k.jpg K083572 - BD BACTEC Plus Aerobic/F Culture Vials K083572 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Dec 2008. https://www.510kdatabase.net/k083657/ 2008-12-24 monthly 0.5 https://www.510kdatabase.net/og-image/k083657-conquest-pta-balloon-dilatation-catheter-fda-510k.jpg K083657 - CONQUEST PTA BALLOON DILATATION CATHETER K083657 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 2008. https://www.510kdatabase.net/k080766/ 2008-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k080766-vidas-rub-igg-fda-510k.jpg K080766 - VIDAS RUB IGG K080766 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Dec 2008. https://www.510kdatabase.net/k081768/ 2008-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k081768-cook-incorporated-polyvinyl-alcohol-fda-510k.jpg K081768 - COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES K081768 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Cook Incorporated. Cleared Dec 2008. https://www.510kdatabase.net/k083576/ 2008-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k083576-miser-contrast-management-system-fda-510k.jpg K083576 - MISER CONTRAST MANAGEMENT SYSTEM K083576 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Dec 2008. https://www.510kdatabase.net/k081207/ 2008-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k081207-intuitive-surgical-da-vinci-s-surgical-fda-510k.jpg K081207 - INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM, MODEL IS2000, WITH DA VINCI CONNECT AND ONSITE K081207 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Dec 2008. https://www.510kdatabase.net/k081930/ 2008-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k081930-unicel-dxh-800-coulter-cellular-fda-510k.jpg K081930 - UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM K081930 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Dec 2008. https://www.510kdatabase.net/k082859/ 2008-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k082859-hemosil-routine-control-level-1-level-fda-510k.jpg K082859 - HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED K082859 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Dec 2008. https://www.510kdatabase.net/k082527/ 2008-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k082527-zimmer-universal-locking-system-35-mm-fda-510k.jpg K082527 - ZIMMER UNIVERSAL LOCKING SYSTEM: 3.5 MM LOCKING PLATES AND SCREWS K082527 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Dec 2008. https://www.510kdatabase.net/k082715/ 2008-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k082715-depuy-global-ap-cta-humeral-head-fda-510k.jpg K082715 - DEPUY GLOBAL AP CTA HUMERAL HEAD K082715 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Dec 2008. https://www.510kdatabase.net/k082925/ 2008-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k082925-xenon-100-scb-light-source-model-fda-510k.jpg K082925 - XENON-100 SCB LIGHT SOURCE, MODEL 20132620 K082925 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Dec 2008. https://www.510kdatabase.net/k083437/ 2008-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k083437-modification-to-t2-recon-nail-system-fda-510k.jpg K083437 - MODIFICATION TO T2 RECON NAIL SYSTEM K083437 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Dec 2008. https://www.510kdatabase.net/k082625/ 2008-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k082625-synthes-usa-35mm-lcp-periarticular-fda-510k.jpg K082625 - SYNTHES (USA) 3.5MM LCP PERIARTICULAR PROXIMAL HUMERUS PLATES K082625 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Dec 2008. https://www.510kdatabase.net/k083392/ 2008-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k083392-novation-1214-cemented-femoral-stems-fda-510k.jpg K083392 - NOVATION 12/14 CEMENTED FEMORAL STEMS K083392 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Dec 2008. https://www.510kdatabase.net/k083498/ 2008-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k083498-philips-model-mx-16-slice-ct-system-fda-510k.jpg K083498 - PHILIPS MODEL MX 16 SLICE CT SYSTEM K083498 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Dec 2008. https://www.510kdatabase.net/k083610/ 2008-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k083610-filtek-supreme-ultra-universal-fda-510k.jpg K083610 - FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVE K083610 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Dec 2008. https://www.510kdatabase.net/k082673/ 2008-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k082673-conserve-pressfit-femoral-component-fda-510k.jpg K082673 - CONSERVE PRESSFIT FEMORAL COMPONENT K082673 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Dec 2008. https://www.510kdatabase.net/k083282/ 2008-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k083282-model-tsx-301b-aquilion-ct-system-fda-510k.jpg K083282 - MODEL TSX-301B AQUILION CT SYSTEM K083282 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Dec 2008. https://www.510kdatabase.net/k083505/ 2008-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k083505-dc-3dc-3t-diagnostic-ultrasound-system-fda-510k.jpg K083505 - DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM K083505 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Dec 2008. https://www.510kdatabase.net/k081824/ 2008-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k081824-bd-probetec-chlamydia-trachomatis-ct-q-fda-510k.jpg K081824 - BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY K081824 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Dec 2008. https://www.510kdatabase.net/k081825/ 2008-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k081825-bd-probetec-neisseria-gonorrhoeae-gc-q-fda-510k.jpg K081825 - BD PROBETEC NEISSERIA GONORRHOEAE (GC) Q AMPLIFIED DNA ASSAY K081825 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Dec 2008. https://www.510kdatabase.net/k082770/ 2008-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k082770-zimmer-natural-nail-system-tibial-nail-fda-510k.jpg K082770 - ZIMMER NATURAL NAIL SYSTEM TIBIAL NAIL K082770 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Dec 2008. https://www.510kdatabase.net/k083364/ 2008-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k083364-25-mm-multidirectional-threaded-pegs-fda-510k.jpg K083364 - 2.5 MM MULTIDIRECTIONAL THREADED PEGS, MODELS 131211110-131211130, 1.5 MM LOCKING SCREWS, MODELS 131220408-131220424 K083364 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Dec 2008. https://www.510kdatabase.net/k080428/ 2008-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k080428-attain-command-6250-left-heart-fda-510k.jpg K080428 - ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND ATTAIN COMMAND 6250 GUIDE CATHETERS FOR LEFT HEART DELIVERY K080428 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Dec 2008. https://www.510kdatabase.net/k082308/ 2008-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k082308-modification-to-vigileo-arterial-fda-510k.jpg K082308 - MODIFICATION TO VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR K082308 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Dec 2008. https://www.510kdatabase.net/k072617/ 2008-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k072617-elecsys-rubella-igg-immunoassay-fda-510k.jpg K072617 - ELECSYS RUBELLA IGG IMMUNOASSAY K072617 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Dec 2008. https://www.510kdatabase.net/k082913/ 2008-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k082913-bd-phoenix-automated-microbiology-fda-510k.jpg K082913 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DOXYCYCLINE (GP) 0.25-16 UG/ML K082913 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Dec 2008. https://www.510kdatabase.net/k082585/ 2008-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k082585-depuy-asphere-m-spec-head-fda-510k.jpg K082585 - DEPUY ASPHERE M-SPEC HEAD K082585 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Dec 2008. https://www.510kdatabase.net/k082670/ 2008-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k082670-modification-to-attain-prevail-fda-510k.jpg K082670 - MODIFICATION TO: ATTAIN PREVAIL 6228CTH80 STEERABLE CATHETER SET K082670 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Dec 2008. https://www.510kdatabase.net/k081739/ 2008-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k081739-2-port-through-the-peg-ttp-jejunostomy-fda-510k.jpg K081739 - 2-PORT THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT K081739 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Dec 2008. https://www.510kdatabase.net/k082540/ 2008-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k082540-ge-entropy-sensor-fda-510k.jpg K082540 - GE ENTROPY SENSOR K082540 is a FDA 510(k) cleared neurology medical device. Manufacturer: Ge Healthcare. Cleared Nov 2008. https://www.510kdatabase.net/k082785/ 2008-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k082785-nihon-kohden-bedside-monitor-bsm-9100a-fda-510k.jpg K082785 - NIHON KOHDEN BEDSIDE MONITOR, BSM 9100A SERIES K082785 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Nov 2008. https://www.510kdatabase.net/k082358/ 2008-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k082358-smith-nephew-inc-patient-matched-fda-510k.jpg K082358 - SMITH & NEPHEW, INC. PATIENT MATCHED TECHNOLOGY K082358 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Nov 2008. https://www.510kdatabase.net/k082654/ 2008-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k082654-enteral-only-extension-set-fda-510k.jpg K082654 - ENTERAL ONLY EXTENSION SET K082654 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Respironics, Inc.. Cleared Nov 2008. https://www.510kdatabase.net/k082002/ 2008-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k082002-progenix-plus-fda-510k.jpg K082002 - PROGENIX PLUS K082002 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Nov 2008. https://www.510kdatabase.net/k082807/ 2008-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k082807-synthes-usa-35-and-45-mm-locking-fda-510k.jpg K082807 - SYNTHES (USA) 3.5 AND 4.5 MM LOCKING COMPRESSION PLATE SYSTEM WITH EXPANDED INDICATIONS K082807 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Nov 2008. https://www.510kdatabase.net/k081080/ 2008-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k081080-tsrh-spinal-system-fda-510k.jpg K081080 - TSRH SPINAL SYSTEM K081080 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Nov 2008. https://www.510kdatabase.net/k082506/ 2008-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k082506-symbia-version-40-fda-510k.jpg K082506 - SYMBIA, VERSION 4.0 K082506 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2008. https://www.510kdatabase.net/k082538/ 2008-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k082538-bd-phoenix-automated-microbiology-fda-510k.jpg K082538 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PHOENIX INDUCIBLE MACROLIDE RESISTANCE TEST K082538 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Nov 2008. https://www.510kdatabase.net/k082851/ 2008-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k082851-multlink-cable-and-leadwire-system-fda-510k.jpg K082851 - MULTLINK CABLE AND LEADWIRE SYSTEM K082851 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Nov 2008. https://www.510kdatabase.net/k082500/ 2008-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k082500-depuy-sigma-cr-f-femoral-component-fda-510k.jpg K082500 - DEPUY SIGMA CR-F FEMORAL COMPONENT K082500 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Nov 2008. https://www.510kdatabase.net/k082650/ 2008-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k082650-synthes-large-external-fixation-mr-fda-510k.jpg K082650 - SYNTHES LARGE EXTERNAL FIXATION, MR CONDITIONAL K082650 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Nov 2008. https://www.510kdatabase.net/k081906/ 2008-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k081906-protex-ct-cervicothoracic-spinal-system-fda-510k.jpg K081906 - PROTEX CT CERVICOTHORACIC SPINAL SYSTEM K081906 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Nov 2008. https://www.510kdatabase.net/k082211/ 2008-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k082211-renasys-f-negative-pressure-wound-fda-510k.jpg K082211 - RENASYS-F NEGATIVE PRESSURE WOUND THERAPY FOAM DRESSING KITS K082211 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Nov 2008. https://www.510kdatabase.net/k083071/ 2008-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k083071-vertex-reconstruction-system-fda-510k.jpg K083071 - VERTEX RECONSTRUCTION SYSTEM K083071 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Nov 2008. https://www.510kdatabase.net/k082335/ 2008-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k082335-synthes-matrixmandible-plate-and-screw-fda-510k.jpg K082335 - SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM K082335 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Nov 2008. https://www.510kdatabase.net/k082463/ 2008-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k082463-progenix-fda-510k.jpg K082463 - PROGENIX K082463 is a FDA 510(k) cleared dental medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Nov 2008. https://www.510kdatabase.net/k082624/ 2008-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k082624-synthes-usa-35mm-lcp-posteromedial-fda-510k.jpg K082624 - SYNTHES (USA) 3.5MM LCP POSTEROMEDIAL PROXIMAL TIBIA PLATES K082624 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Nov 2008. https://www.510kdatabase.net/k082072/ 2008-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k082072-synthes-usa-35mm-lcp-hook-plate-fda-510k.jpg K082072 - SYNTHES (USA) 3.5MM LCP HOOK PLATE K082072 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Nov 2008. https://www.510kdatabase.net/k082427/ 2008-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k082427-syngo-mr-b17-fda-510k.jpg K082427 - SYNGO MR B17 K082427 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2008. https://www.510kdatabase.net/k082475/ 2008-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k082475-reveal-xt-insertable-cardiac-monitor-fda-510k.jpg K082475 - REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529, REVEL DX INSERTABLE CARDIAC MONITOR, MODEL 9528 K082475 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Nov 2008. https://www.510kdatabase.net/k082252/ 2008-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k082252-independence-spacer-fda-510k.jpg K082252 - INDEPENDENCE SPACER K082252 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Nov 2008. https://www.510kdatabase.net/k082320/ 2008-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k082320-darco-small-screw-fda-510k.jpg K082320 - DARCO SMALL SCREW K082320 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Nov 2008. https://www.510kdatabase.net/k082078/ 2008-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k082078-zimmer-periarticular-locking-plate-fda-510k.jpg K082078 - ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM: DISTAL HUMERAL AND PROXIMAL ULNA PLATES K082078 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Nov 2008. https://www.510kdatabase.net/k082305/ 2008-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k082305-g2-express-filter-system-femoral-and-fda-510k.jpg K082305 - G2 EXPRESS FILTER SYSTEM - FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS K082305 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 2008. https://www.510kdatabase.net/k081857/ 2008-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k081857-dimension-siro-flex-reagent-cartridge-fda-510k.jpg K081857 - DIMENSION SIRO FLEX REAGENT CARTRIDGE AND DIMENSION SIROLIMUS CALBIRATOR, MODELS DR 306, DC 306 K081857 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Oct 2008. https://www.510kdatabase.net/k082267/ 2008-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k082267-pigalileo-cas-version-40-and-tkr-base-fda-510k.jpg K082267 - PIGALILEO CAS, VERSION 4.0 AND TKR BASE, VERSION 2.1 K082267 is a FDA 510(k) cleared neurology medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 2008. https://www.510kdatabase.net/k082847/ 2008-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k082847-pinnacle-roii-introducer-sheath-fda-510k.jpg K082847 - PINNACLE ROII INTRODUCER SHEATH K082847 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Oct 2008. https://www.510kdatabase.net/k082595/ 2008-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k082595-modification-toaccu-chek-pocket-fda-510k.jpg K082595 - MODIFICATION TO:ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE K082595 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Roche Diagnostics. Cleared Oct 2008. https://www.510kdatabase.net/k081248/ 2008-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k081248-quanta-lite-omp-plus-elisa-fda-510k.jpg K081248 - QUANTA LITE OMP PLUS ELISA K081248 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Oct 2008. https://www.510kdatabase.net/k081733/ 2008-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k081733-10mm-x-40mm-uncovered-wallflex-fda-510k.jpg K081733 - 10MM X 40MM UNCOVERED WALLFLEX BILLIARY RX STENT SYSTEM, MODEL M00570890 K081733 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Oct 2008. https://www.510kdatabase.net/k082464/ 2008-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k082464-prostiva-rf-therapy-hand-piece-model-fda-510k.jpg K082464 - PROSTIVA RF THERAPY HAND PIECE, MODEL 8929 K082464 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medtronic, Inc.. Cleared Oct 2008. https://www.510kdatabase.net/k080944/ 2008-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k080944-x-force-nephrostomy-balloon-dilation-fda-510k.jpg K080944 - X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER K080944 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 2008. https://www.510kdatabase.net/k082139/ 2008-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k082139-edwards-bovine-pericardial-patch-model-fda-510k.jpg K082139 - EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700 K082139 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Oct 2008. https://www.510kdatabase.net/k081023/ 2008-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k081023-evolis-total-knee-system-fda-510k.jpg K081023 - EVOLIS TOTAL KNEE SYSTEM K081023 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Oct 2008. https://www.510kdatabase.net/k083001/ 2008-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k083001-m5-diagnostic-ultrasound-system-fda-510k.jpg K083001 - M5 DIAGNOSTIC ULTRASOUND SYSTEM K083001 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Oct 2008. https://www.510kdatabase.net/k081594/ 2008-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k081594-medline-powder-free-nitrile-fda-510k.jpg K081594 - MEDLINE POWDER-FREE NITRILE EXAMINATION GLOVE WITH ALOE K081594 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Oct 2008. https://www.510kdatabase.net/k082687/ 2008-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k082687-collamend-fm-implant-fda-510k.jpg K082687 - COLLAMEND FM IMPLANT K082687 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 2008. https://www.510kdatabase.net/k083014/ 2008-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k083014-atlas-speeder-headcervical-coil-model-fda-510k.jpg K083014 - ATLAS SPEEDER HEAD/CERVICAL COIL, MODEL MJAH-137A K083014 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Oct 2008. https://www.510kdatabase.net/k082732/ 2008-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k082732-modification-to-capstone-spinal-system-fda-510k.jpg K082732 - MODIFICATION TO: CAPSTONE SPINAL SYSTEM K082732 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Oct 2008. https://www.510kdatabase.net/k082928/ 2008-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k082928-straight-fire-holmium-laser-fiber-fda-510k.jpg K082928 - STRAIGHT FIRE HOLMIUM LASER FIBER K082928 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Boston Scientific Corp. Cleared Oct 2008. https://www.510kdatabase.net/k082063/ 2008-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k082063-prelude-short-sheath-introducer-fda-510k.jpg K082063 - PRELUDE SHORT SHEATH INTRODUCER K082063 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Oct 2008. https://www.510kdatabase.net/k082446/ 2008-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k082446-biomet-metal-on-metal-hip-systems-fda-510k.jpg K082446 - BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATIONS K082446 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Oct 2008. https://www.510kdatabase.net/k082681/ 2008-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k082681-vacora-vacuum-assisted-biopsy-system-fda-510k.jpg K082681 - VACORA VACUUM ASSISTED BIOPSY SYSTEM K082681 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 2008. https://www.510kdatabase.net/k082684/ 2008-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k082684-4d-viewer-radiology-model-uswp-100a-fda-510k.jpg K082684 - 4D VIEWER RADIOLOGY, MODEL USWP-100A K082684 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Oct 2008. https://www.510kdatabase.net/k081717/ 2008-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k081717-tricos-a-resorbable-bone-substitute-fda-510k.jpg K081717 - TRICOS A RESORBABLE BONE SUBSTITUTE K081717 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Baxter Healthcare Corp. Cleared Oct 2008. https://www.510kdatabase.net/k082018/ 2008-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k082018-t2-flexible-nail-fda-510k.jpg K082018 - T2 FLEXIBLE NAIL K082018 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Oct 2008. https://www.510kdatabase.net/k082046/ 2008-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k082046-karl-storz-pediatric-flexible-cysto-fda-510k.jpg K082046 - KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11278C1/ACUI AND CIRCON AUR-735 PEDIATRIC CYSTOURETHEROSCO K082046 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Oct 2008. https://www.510kdatabase.net/k082220/ 2008-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k082220-somatom-flash-ds-fda-510k.jpg K082220 - SOMATOM FLASH DS K082220 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 2008. https://www.510kdatabase.net/k082236/ 2008-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k082236-cd-horizon-spinal-system-fda-510k.jpg K082236 - CD HORIZON SPINAL SYSTEM K082236 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Oct 2008. https://www.510kdatabase.net/k082653/ 2008-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k082653-centering-intraluminal-applicator-fda-510k.jpg K082653 - CENTERING INTRALUMINAL APPLICATOR K082653 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Oct 2008. https://www.510kdatabase.net/k082702/ 2008-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k082702-exactech-equinoxe-reverse-shoulder-fda-510k.jpg K082702 - EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM+15MM HUMERAL ADAPTER TRAY K082702 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Oct 2008. https://www.510kdatabase.net/k082830/ 2008-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k082830-infx-8000h-infinix-i-fda-510k.jpg K082830 - INFX-8000H, INFINIX-I K082830 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Oct 2008. https://www.510kdatabase.net/k080194/ 2008-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k080194-vidas-cea-s-assay-fda-510k.jpg K080194 - VIDAS CEA (S) ASSAY K080194 is a FDA 510(k) cleared immunology medical device. Manufacturer: bioMerieux, Inc.. Cleared Oct 2008. https://www.510kdatabase.net/k082442/ 2008-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k082442-modification-to-microfuse-bone-void-fda-510k.jpg K082442 - MODIFICATION TO MICROFUSE BONE VOID FILLER K082442 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Oct 2008. https://www.510kdatabase.net/k071969/ 2008-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k071969-sen-4100-electric-stimulator-fda-510k.jpg K071969 - SEN-4100 ELECTRIC STIMULATOR K071969 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Oct 2008. https://www.510kdatabase.net/k082271/ 2008-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k082271-fluconazole-25ug-bbl-sensi-disc-fda-510k.jpg K082271 - FLUCONAZOLE 25UG BBL SENSI-DISC K082271 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Oct 2008. https://www.510kdatabase.net/k081799/ 2008-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k081799-gore-tri-lobe-balloon-catheter-fda-510k.jpg K081799 - GORE TRI-LOBE BALLOON CATHETER K081799 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Oct 2008. https://www.510kdatabase.net/k082567/ 2008-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k082567-stryker-compartmental-knee-system-line-fda-510k.jpg K082567 - STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSION K082567 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Oct 2008. https://www.510kdatabase.net/k082272/ 2008-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k082272-voriconazole-1ug-bbl-sensi-disc-fda-510k.jpg K082272 - VORICONAZOLE 1UG BBL SENSI-DISC K082272 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Oct 2008. https://www.510kdatabase.net/k082331/ 2008-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k082331-magnetom-c-fda-510k.jpg K082331 - MAGNETOM C! K082331 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 2008. https://www.510kdatabase.net/k082571/ 2008-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k082571-avaulta-support-system-fda-510k.jpg K082571 - AVAULTA SUPPORT SYSTEM K082571 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Sep 2008. https://www.510kdatabase.net/k081777/ 2008-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k081777-ventrio-hernia-patch-fda-510k.jpg K081777 - VENTRIO HERNIA PATCH K081777 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Sep 2008. https://www.510kdatabase.net/k080017/ 2008-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k080017-vidas-afp-assay-fda-510k.jpg K080017 - VIDAS AFP ASSAY K080017 is a FDA 510(k) cleared immunology medical device. Manufacturer: bioMerieux, Inc.. Cleared Sep 2008. https://www.510kdatabase.net/k081231/ 2008-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k081231-architect-iphenobarbital-reagents-and-fda-510k.jpg K081231 - ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33 K081231 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Sep 2008. https://www.510kdatabase.net/k081808/ 2008-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k081808-acunav-v-ultrasound-catheter-fda-510k.jpg K081808 - ACUNAV V ULTRASOUND CATHETER K081808 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 2008. https://www.510kdatabase.net/k081860/ 2008-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k081860-zimmer-segmental-system-variable-fda-510k.jpg K081860 - ZIMMER SEGMENTAL SYSTEM VARIABLE STIFFNESS STEM EXTENSIONS AND INTERCALARY SEGMENTS K081860 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Sep 2008. https://www.510kdatabase.net/k082317/ 2008-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k082317-ge-lunar-frax-10-year-fracture-risk-fda-510k.jpg K082317 - GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION K082317 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Sep 2008. https://www.510kdatabase.net/k082519/ 2008-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k082519-finecross-mg-coronary-micro-guide-fda-510k.jpg K082519 - FINECROSS MG CORONARY MICRO-GUIDE CATHETER K082519 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Sep 2008. https://www.510kdatabase.net/k082736/ 2008-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k082736-radifocus-optitorque-angiographic-fda-510k.jpg K082736 - RADIFOCUS OPTITORQUE ANGIOGRAPHIC CATHETER K082736 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Sep 2008. https://www.510kdatabase.net/k082596/ 2008-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k082596-ultraextend-usws-900a-fda-510k.jpg K082596 - ULTRAEXTEND USWS-900A K082596 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Sep 2008. https://www.510kdatabase.net/k081779/ 2008-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k081779-golox-93-fda-510k.jpg K081779 - GOLOX-93 K081779 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Sep 2008. https://www.510kdatabase.net/k082644/ 2008-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k082644-glidesheath-fda-510k.jpg K082644 - GLIDESHEATH K082644 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Sep 2008. https://www.510kdatabase.net/k081784/ 2008-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k081784-mastergraft-putty-fda-510k.jpg K081784 - MASTERGRAFT PUTTY K081784 is a FDA 510(k) cleared dental medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Sep 2008. https://www.510kdatabase.net/k082362/ 2008-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k082362-surshield-safety-iv-catheter-fda-510k.jpg K082362 - SURSHIELD SAFETY I.V. CATHETER K082362 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terumo Medical Corp.. Cleared Sep 2008. https://www.510kdatabase.net/k082516/ 2008-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k082516-peri-loc-periarticular-locked-plating-fda-510k.jpg K082516 - PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM HEXALOBULAR BONE SCREWS K082516 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Sep 2008. https://www.510kdatabase.net/k082342/ 2008-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k082342-modification-to-capstone-spinal-system-fda-510k.jpg K082342 - MODIFICATION TO CAPSTONE SPINAL SYSTEM K082342 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Sep 2008. https://www.510kdatabase.net/k082494/ 2008-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k082494-drad3000eradrex-i-fda-510k.jpg K082494 - DRAD3000E/RADREX-I K082494 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Sep 2008. https://www.510kdatabase.net/k080696/ 2008-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k080696-architect-iphenytoin-reagents-and-fda-510k.jpg K080696 - ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01 K080696 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Sep 2008. https://www.510kdatabase.net/k081338/ 2008-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k081338-roche-elecsys-anti-ccp-immunoassay-fda-510k.jpg K081338 - ROCHE ELECSYS ANTI-CCP IMMUNOASSAY, ROCHE ELECSYS PRECICONTROL ANTI-CCP K081338 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics. Cleared Sep 2008. https://www.510kdatabase.net/k081789/ 2008-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k081789-dimension-clinical-chemistry-system-fda-510k.jpg K081789 - DIMENSION CLINICAL CHEMISTRY SYSTEM ENZYME I CALIBRATOR K081789 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Sep 2008. https://www.510kdatabase.net/k081374/ 2008-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k081374-charlotte-lisfranc-bone-screw-fda-510k.jpg K081374 - CHARLOTTE LISFRANC BONE SCREW, CHARLOTTE LISFRANC PLATE K081374 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Sep 2008. https://www.510kdatabase.net/k081623/ 2008-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k081623-synthes-rib-fixation-system-fda-510k.jpg K081623 - SYNTHES RIB FIXATION SYSTEM K081623 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Sep 2008. https://www.510kdatabase.net/k073615/ 2008-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k073615-brainlab-knee-essential-brainlab-knee-fda-510k.jpg K073615 - BRAINLAB KNEE ESSENTIAL, BRAINLAB KNEE UNLIMITED CI KNEE, CI KNEE UNLIMITED K073615 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Sep 2008. https://www.510kdatabase.net/k080332/ 2008-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k080332-polyflex-stent-system-with-delivery-fda-510k.jpg K080332 - POLYFLEX STENT SYSTEM WITH DELIVERY SYSTEM, MODEL M00514270, M00514280, 00514290, 00514300, 00514310, 00514320, 00514330 K080332 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Sep 2008. https://www.510kdatabase.net/k081016/ 2008-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k081016-smith-nephew-inc-promos-reverse-fda-510k.jpg K081016 - SMITH & NEPHEW, INC., PROMOS REVERSE SHOULDER SYSTEM K081016 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Sep 2008. https://www.510kdatabase.net/k081747/ 2008-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k081747-modification-to-synthes-usa-condylar-fda-510k.jpg K081747 - MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM K081747 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Sep 2008. https://www.510kdatabase.net/k082216/ 2008-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k082216-tbd-ethicon-mesh-fda-510k.jpg K082216 - TBD ETHICON MESH K082216 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Sep 2008. https://www.510kdatabase.net/k082426/ 2008-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k082426-renasys-ez-fda-510k.jpg K082426 - RENASYS EZ K082426 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Sep 2008. https://www.510kdatabase.net/k080420/ 2008-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k080420-resert-xl-hld-high-level-disinfectant-fda-510k.jpg K080420 - RESERT XL HLD HIGH LEVEL DISINFECTANT K080420 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Sep 2008. https://www.510kdatabase.net/k082022/ 2008-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k082022-optetrak-9mm-cruciate-retaining-tibial-fda-510k.jpg K082022 - OPTETRAK 9MM CRUCIATE RETAINING TIBIAL INSERT, SLOPE ++ K082022 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Sep 2008. https://www.510kdatabase.net/k080546/ 2008-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k080546-nihon-kohden-eeg-1200a-series-neurofax-fda-510k.jpg K080546 - NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A K080546 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Aug 2008. https://www.510kdatabase.net/k082239/ 2008-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k082239-depuy-c-stem-amt-fda-510k.jpg K082239 - DEPUY C-STEM AMT K082239 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Aug 2008. https://www.510kdatabase.net/k082306/ 2008-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k082306-powerloc-clear-safety-infusion-set-fda-510k.jpg K082306 - POWERLOC CLEAR SAFETY INFUSION SET K082306 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Aug 2008. https://www.510kdatabase.net/k082356/ 2008-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k082356-gore-introducer-sheath-with-silicone-fda-510k.jpg K082356 - GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE K082356 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Aug 2008. https://www.510kdatabase.net/k081275/ 2008-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k081275-boston-scientific-surgical-mesh-fda-510k.jpg K081275 - BOSTON SCIENTIFIC SURGICAL MESH K081275 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Aug 2008. https://www.510kdatabase.net/k082112/ 2008-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k082112-t2-xvbr-spinal-system-fda-510k.jpg K082112 - T2 XVBR SPINAL SYSTEM K082112 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Aug 2008. https://www.510kdatabase.net/k081511/ 2008-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k081511-20-pk-suture-anchor-t-20-pk-suture-fda-510k.jpg K081511 - 2.0 PK SUTURE ANCHOR T, 2.0 PK SUTURE ANCHOR S K081511 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Aug 2008. https://www.510kdatabase.net/k081546/ 2008-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k081546-small-bone-locking-plating-system-fda-510k.jpg K081546 - SMALL BONE LOCKING PLATING SYSTEM K081546 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Aug 2008. https://www.510kdatabase.net/k082143/ 2008-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k082143-micro-guide-catheter-xp-fda-510k.jpg K082143 - MICRO GUIDE CATHETER XP K082143 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Aug 2008. https://www.510kdatabase.net/k080643/ 2008-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k080643-elecsys-anti-tshr-calcheck-fda-510k.jpg K080643 - ELECSYS ANTI-TSHR CALCHECK K080643 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Aug 2008. https://www.510kdatabase.net/k081048/ 2008-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k081048-pinnacle-pelvic-floor-repair-kit-ii-fda-510k.jpg K081048 - PINNACLE PELVIC FLOOR REPAIR KIT II K081048 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Boston Scientific Corp. Cleared Aug 2008. https://www.510kdatabase.net/k081600/ 2008-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k081600-steris-resert-xl-test-strip-fda-510k.jpg K081600 - STERIS RESERT XL TEST STRIP K081600 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Aug 2008. https://www.510kdatabase.net/k081722/ 2008-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k081722-ysio-fda-510k.jpg K081722 - YSIO K081722 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 2008. https://www.510kdatabase.net/k082030/ 2008-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k082030-dimension-vista-csae-calibrator-model-fda-510k.jpg K082030 - DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440 K082030 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Aug 2008. https://www.510kdatabase.net/k081566/ 2008-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k081566-smith-nephew-oxinium-dh-femoral-heads-fda-510k.jpg K081566 - SMITH & NEPHEW OXINIUM DH FEMORAL HEADS K081566 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Aug 2008. https://www.510kdatabase.net/k082244/ 2008-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k082244-pca-8000a-mark-11-pet-ct-system-fda-510k.jpg K082244 - PCA-8000A, MARK 11, PET / CT SYSTEM K082244 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Aug 2008. https://www.510kdatabase.net/k081549/ 2008-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k081549-rx-accunet-lp-embolic-protection-system-fda-510k.jpg K081549 - RX ACCUNET LP EMBOLIC PROTECTION SYSTEM K081549 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Laboratories. Cleared Aug 2008. https://www.510kdatabase.net/k081038/ 2008-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k081038-atlantis-anterior-cervical-plate-system-fda-510k.jpg K081038 - ATLANTIS ANTERIOR CERVICAL PLATE SYSTEM K081038 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Aug 2008. https://www.510kdatabase.net/k081526/ 2008-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k081526-flowcare-tlg-reagent-fda-510k.jpg K081526 - FLOWCARE TLG REAGENT K081526 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Aug 2008. https://www.510kdatabase.net/k082119/ 2008-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k082119-aplio-xg-diagnostic-ultrasound-system-fda-510k.jpg K082119 - APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 3.0 K082119 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Aug 2008. https://www.510kdatabase.net/k080634/ 2008-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k080634-access-stfr-access-stfr-calibrators-fda-510k.jpg K080634 - ACCESS STFR, ACCESS STFR CALIBRATORS, AND ACCESS STFR QC WITH MODELS, A32493, A32494, AND A32495 K080634 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Aug 2008. https://www.510kdatabase.net/k082148/ 2008-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k082148-synthes-usa-elastic-intramedullary-fda-510k.jpg K082148 - SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP, LINE EXTENSION K082148 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Aug 2008. https://www.510kdatabase.net/k080737/ 2008-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k080737-miraflex-high-flow-microcatheter-fda-510k.jpg K080737 - MIRAFLEX HIGH FLOW MICROCATHETER K080737 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Aug 2008. https://www.510kdatabase.net/k080990/ 2008-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k080990-depuy-global-cap-cta-resurfacing-fda-510k.jpg K080990 - DEPUY GLOBAL C.AP. CTA RESURFACING SHOULDER K080990 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Aug 2008. https://www.510kdatabase.net/k081021/ 2008-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k081021-kinetix-guidewire-plus-guidewire-fda-510k.jpg K081021 - KINETIX GUIDEWIRE, PLUS GUIDEWIRE K081021 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Aug 2008. https://www.510kdatabase.net/k081299/ 2008-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k081299-dimension-vista-system-trf-flex-fda-510k.jpg K081299 - DIMENSION VISTA SYSTEM TRF FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA K081299 is a FDA 510(k) cleared immunology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Aug 2008. https://www.510kdatabase.net/k081337/ 2008-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k081337-approach-cto-wire-guide-fda-510k.jpg K081337 - APPROACH CTO WIRE GUIDE K081337 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Aug 2008. https://www.510kdatabase.net/k073396/ 2008-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k073396-antimicrobial-ultrasite-value-fda-510k.jpg K073396 - ANTIMICROBIAL ULTRASITE VALUE, ULTRASITE AG K073396 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Aug 2008. https://www.510kdatabase.net/k073499/ 2008-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k073499-versys-epoch-fullcoat-hip-prosthesis-fda-510k.jpg K073499 - VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES K073499 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Aug 2008. https://www.510kdatabase.net/k081721/ 2008-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k081721-tricos-a-resorbable-substitute-fda-510k.jpg K081721 - TRICOS A RESORBABLE SUBSTITUTE K081721 is a FDA 510(k) cleared dental medical device. Manufacturer: Baxter Healthcare Corp. Cleared Aug 2008. https://www.510kdatabase.net/k081921/ 2008-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k081921-ge-vivid-e9-ultrasound-fda-510k.jpg K081921 - GE VIVID E9 ULTRASOUND K081921 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Aug 2008. https://www.510kdatabase.net/k081804/ 2008-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k081804-pioneer-plus-catheter-fda-510k.jpg K081804 - PIONEER PLUS CATHETER K081804 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Aug 2008. https://www.510kdatabase.net/k081992/ 2008-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k081992-dimension-vista-csae-flex-regent-fda-510k.jpg K081992 - DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108 K081992 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Aug 2008. https://www.510kdatabase.net/k081289/ 2008-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k081289-v-link-antimicrobial-luer-activated-fda-510k.jpg K081289 - V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE AND EXTENSION SETS WITH V-LINK ANTIMICROBIAL LUER ACTIVATED DEVICE K081289 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Aug 2008. https://www.510kdatabase.net/k081319/ 2008-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k081319-dimension-clinical-chemistry-system-fda-510k.jpg K081319 - DIMENSION CLINICAL CHEMISTRY SYSTEM LIPASE CALIBRATOR, MODEL DC56 K081319 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Aug 2008. https://www.510kdatabase.net/k073112/ 2008-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k073112-da-vinci-sonicpro-cleaning-system-fda-510k.jpg K073112 - DA VINCI SONICPRO CLEANING SYSTEM, MODEL 400253 K073112 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Aug 2008. https://www.510kdatabase.net/k073523/ 2008-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k073523-interceptor-plus-coronary-filter-systems-fda-510k.jpg K073523 - INTERCEPTOR PLUS CORONARY FILTER SYSTEMS K073523 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Aug 2008. https://www.510kdatabase.net/k080037/ 2008-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k080037-modification-to-zilver-635-biliary-stent-fda-510k.jpg K080037 - MODIFICATION TO ZILVER 635 BILIARY STENT K080037 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook, Inc.. Cleared Aug 2008. https://www.510kdatabase.net/k081124/ 2008-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k081124-mdf-revision-hip-system-fda-510k.jpg K081124 - MDF REVISION HIP SYSTEM K081124 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 2008. https://www.510kdatabase.net/k080668/ 2008-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k080668-g2-express-filter-system-femoral-fda-510k.jpg K080668 - G2 EXPRESS FILTER SYSTEM-FEMORAL (RF400F) AND JUGULAR/SUBCLAVIAN (RF400J) DELIVERY KITS K080668 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jul 2008. https://www.510kdatabase.net/k081113/ 2008-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k081113-cook-and-cook-spectrum-central-venous-fda-510k.jpg K081113 - COOK AND COOK SPECTRUM CENTRAL VENOUS CATHETERS K081113 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cook, Inc.. Cleared Jul 2008. https://www.510kdatabase.net/k081294/ 2008-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k081294-advia-chemistry-cardiophase-high-fda-510k.jpg K081294 - ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP), CALIBRATORS K081294 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Jul 2008. https://www.510kdatabase.net/k080092/ 2008-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k080092-elecsys-anti-tshr-immunoassay-elecsys-fda-510k.jpg K080092 - ELECSYS ANTI-TSHR IMMUNOASSAY, ELECSYS PRECICONTROL THYROAB K080092 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jul 2008. https://www.510kdatabase.net/k081161/ 2008-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k081161-dimension-vista-system-igg-flex-fda-510k.jpg K081161 - DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST K081161 is a FDA 510(k) cleared immunology medical device. Manufacturer: Dade Behring, Inc.. Cleared Jul 2008. https://www.510kdatabase.net/k081206/ 2008-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k081206-homelox-fda-510k.jpg K081206 - HOMELOX K081206 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Jul 2008. https://www.510kdatabase.net/k080664/ 2008-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k080664-relieve-laminoplasty-fixation-system-fda-510k.jpg K080664 - RELIEVE LAMINOPLASTY FIXATION SYSTEM K080664 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Jul 2008. https://www.510kdatabase.net/k081351/ 2008-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k081351-modification-to-journey-unicondylar-fda-510k.jpg K081351 - MODIFICATION TO JOURNEY UNICONDYLAR FEMORAL IMPLANT K081351 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 2008. https://www.510kdatabase.net/k081111/ 2008-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k081111-legion-hinge-knee-system-fda-510k.jpg K081111 - LEGION HINGE KNEE SYSTEM K081111 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 2008. https://www.510kdatabase.net/k081353/ 2008-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k081353-synthes-usa-tomofix-medial-distal-fda-510k.jpg K081353 - SYNTHES (USA) TOMOFIX MEDIAL DISTAL FEMUR PLATES K081353 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jul 2008. https://www.510kdatabase.net/k081171/ 2008-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k081171-tritanium-acetabular-shell-system-fda-510k.jpg K081171 - TRITANIUM ACETABULAR SHELL SYSTEM K081171 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jul 2008. https://www.510kdatabase.net/k081249/ 2008-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k081249-dimension-vista-system-a2mac-flex-fda-510k.jpg K081249 - DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEM K081249 is a FDA 510(k) cleared immunology medical device. Manufacturer: Dade Behring, Inc.. Cleared Jul 2008. https://www.510kdatabase.net/k080875/ 2008-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k080875-pigalileo-4th-generation-system-fda-510k.jpg K080875 - PIGALILEO 4TH GENERATION SYSTEM K080875 is a FDA 510(k) cleared neurology medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 2008. https://www.510kdatabase.net/k081284/ 2008-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k081284-variax-distal-fibula-plate-fda-510k.jpg K081284 - VARIAX DISTAL FIBULA PLATE K081284 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jul 2008. https://www.510kdatabase.net/k081288/ 2008-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k081288-aspira-peritoneal-drainage-system-fda-510k.jpg K081288 - ASPIRA PERITONEAL DRAINAGE SYSTEM K081288 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jul 2008. https://www.510kdatabase.net/k081452/ 2008-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k081452-synthes-usa-stainless-steel-elastic-fda-510k.jpg K081452 - SYNTHES (USA) STAINLESS STEEL ELASTIC INTRAMEDULLARY NAIL SYSTEM K081452 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jul 2008. https://www.510kdatabase.net/k081446/ 2008-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k081446-bd-spinal-needle-models-405081-405235-fda-510k.jpg K081446 - BD SPINAL NEEDLE, MODELS: 405081, 405235, 405236, 405237 K081446 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Jul 2008. https://www.510kdatabase.net/k081700/ 2008-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k081700-synthes-usa-sternal-fixation-system-fda-510k.jpg K081700 - SYNTHES (USA) STERNAL FIXATION SYSTEM - LINE EXTENSION K081700 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jul 2008. https://www.510kdatabase.net/k081716/ 2008-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k081716-advia-centaur-havm-assay-fda-510k.jpg K081716 - ADVIA CENTAUR HAVM ASSAY K081716 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared Jul 2008. https://www.510kdatabase.net/k073115/ 2008-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k073115-orthomesh-fda-510k.jpg K073115 - ORTHOMESH K073115 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jul 2008. https://www.510kdatabase.net/k081389/ 2008-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k081389-accu-chek-compact-plus-blood-glucose-fda-510k.jpg K081389 - ACCU-CHEK COMPACT PLUS BLOOD GLUCOSE MONITORING SYSTEM K081389 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Jul 2008. https://www.510kdatabase.net/k081437/ 2008-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k081437-mac-1600-ecg-analysis-system-fda-510k.jpg K081437 - MAC 1600 ECG ANALYSIS SYSTEM K081437 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Jul 2008. https://www.510kdatabase.net/k080982/ 2008-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k080982-sterling-es-monorail-and-over-the-wire-fda-510k.jpg K080982 - STERLING ES MONORAIL AND OVER-THE-WIRE PTA BALLOON DILATATION CATHETERS K080982 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Jul 2008. https://www.510kdatabase.net/k081188/ 2008-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k081188-trilogy-with-external-system-gating-fda-510k.jpg K081188 - TRILOGY WITH EXTERNAL SYSTEM GATING INTERFACE K081188 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Jul 2008. https://www.510kdatabase.net/k081690/ 2008-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k081690-spectrum-turbo-ject-peripherally-fda-510k.jpg K081690 - SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER K081690 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cook, Inc.. Cleared Jul 2008. https://www.510kdatabase.net/k080642/ 2008-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k080642-comprehensive-reverse-shoulder-fda-510k.jpg K080642 - COMPREHENSIVE REVERSE SHOULDER K080642 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jul 2008. https://www.510kdatabase.net/k081373/ 2008-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k081373-evolve-eps-system-fda-510k.jpg K081373 - EVOLVE EPS SYSTEM K081373 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jul 2008. https://www.510kdatabase.net/k081391/ 2008-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k081391-vip-anterior-cervical-plate-system-fda-510k.jpg K081391 - VIP ANTERIOR CERVICAL PLATE SYSTEM K081391 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Jul 2008. https://www.510kdatabase.net/k073303/ 2008-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k073303-norian-drillable-fda-510k.jpg K073303 - NORIAN DRILLABLE K073303 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jul 2008. https://www.510kdatabase.net/k080991/ 2008-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k080991-depuy-asr-xl-modular-acetabular-cup-fda-510k.jpg K080991 - DEPUY ASR XL MODULAR ACETABULAR CUP SYSTEM K080991 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jul 2008. https://www.510kdatabase.net/k081205/ 2008-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k081205-synthes-usa-50mm73mm-crimp-positioning-fda-510k.jpg K081205 - SYNTHES (USA) 5.0MM/7.3MM CRIMP POSITIONING PINS K081205 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jul 2008. https://www.510kdatabase.net/k081620/ 2008-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k081620-modification-to-depuy-delta-xtend-fda-510k.jpg K081620 - MODIFICATION TO DEPUY DELTA XTEND REVERSE SHOULDER SYSTEM K081620 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jun 2008. https://www.510kdatabase.net/k080617/ 2008-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k080617-power-drive-art1-2304-with-motor-fda-510k.jpg K080617 - POWER DRIVE ART1 2304 WITH MOTOR HANDLES, TOOLS AND ACCESSORIES K080617 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Jun 2008. https://www.510kdatabase.net/k081573/ 2008-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k081573-medtronic-export-ap-catheter-fda-510k.jpg K081573 - MEDTRONIC EXPORT AP CATHETER K081573 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jun 2008. https://www.510kdatabase.net/k081362/ 2008-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k081362-platelia-lyme-igm-fda-510k.jpg K081362 - PLATELIA LYME IGM K081362 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bio-Rad. Cleared Jun 2008. https://www.510kdatabase.net/k071603/ 2008-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k071603-dimension-vista-carcinoembryonic-fda-510k.jpg K071603 - DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA) K071603 is a FDA 510(k) cleared immunology medical device. Manufacturer: Dade Behring, Inc.. Cleared Jun 2008. https://www.510kdatabase.net/k080812/ 2008-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k080812-hemoccult-ict-fda-510k.jpg K080812 - HEMOCCULT ICT K080812 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jun 2008. https://www.510kdatabase.net/k080886/ 2008-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k080886-iplan-rt-image-fda-510k.jpg K080886 - IPLAN RT IMAGE K080886 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab AG. Cleared Jun 2008. https://www.510kdatabase.net/k063261/ 2008-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k063261-nuclisens-easyq-enterovirus-system-fda-510k.jpg K063261 - NUCLISENS EASYQ ENTEROVIRUS SYSTEM K063261 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jun 2008. https://www.510kdatabase.net/k073280/ 2008-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k073280-beneview-t-series-patient-monitors-fda-510k.jpg K073280 - BENEVIEW T SERIES PATIENT MONITORS, MODELS T8, T6 AND T5 K073280 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Jun 2008. https://www.510kdatabase.net/k081453/ 2008-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k081453-biograph-hd-family-fda-510k.jpg K081453 - BIOGRAPH HD FAMILY K081453 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 2008. https://www.510kdatabase.net/k081621/ 2008-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k081621-infx-8000c-infinix-cc-i-and-vc-i-fda-510k.jpg K081621 - INFX-8000C (INFINIX CC-I AND VC-I) K081621 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Jun 2008. https://www.510kdatabase.net/k081624/ 2008-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k081624-infx-8000f-infinix-csi-and-infinix-dpi-fda-510k.jpg K081624 - INFX-8000F (INFINIX CSI AND INFINIX DPI) K081624 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Jun 2008. https://www.510kdatabase.net/k080251/ 2008-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k080251-apexpro-telemetry-systems-fda-510k.jpg K080251 - APEXPRO TELEMETRY SYSTEMS K080251 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Jun 2008. https://www.510kdatabase.net/k080811/ 2008-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k080811-tina-quant-cystatin-c-calibrator-fas-fda-510k.jpg K080811 - TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYSTATIN C ANDCYSTATIN C CONTROL SET K080811 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jun 2008. https://www.510kdatabase.net/k072876/ 2008-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k072876-prontosan-wound-irrigation-solution-fda-510k.jpg K072876 - PRONTOSAN WOUND IRRIGATION SOLUTION K072876 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Jun 2008. https://www.510kdatabase.net/k081491/ 2008-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k081491-smith-nephew-cds-system-fda-510k.jpg K081491 - SMITH & NEPHEW CDS SYSTEM K081491 is a FDA 510(k) cleared radiology medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jun 2008. https://www.510kdatabase.net/k081106/ 2008-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k081106-peri-loc-periarticular-locked-plating-fda-510k.jpg K081106 - PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM VOLAR DISTAL RADIUS LOCKING PLATE FOR THE UPPER EXTREMITY-ASTM F139 K081106 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jun 2008. https://www.510kdatabase.net/k081582/ 2008-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k081582-infx-8000v-infinix-cfi-and-infinix-vfi-fda-510k.jpg K081582 - INFX-8000V, INFINIX-CFI AND INFINIX VFI K081582 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Jun 2008. https://www.510kdatabase.net/k073598/ 2008-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k073598-bard-dignicare-stool-management-system-fda-510k.jpg K073598 - BARD DIGNICARE STOOL MANAGEMENT SYSTEM K073598 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jun 2008. https://www.510kdatabase.net/k081212/ 2008-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k081212-mrsaselect-extended-incubation-fda-510k.jpg K081212 - MRSASELECT - EXTENDED INCUBATION K081212 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bio-Rad. Cleared Jun 2008. https://www.510kdatabase.net/k080330/ 2008-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k080330-segmental-distal-femoral-components-fda-510k.jpg K080330 - SEGMENTAL DISTAL FEMORAL COMPONENTS AND PROXIMAL FEMORAL BODIES WITH A COMPRESS FEMALE TAPER K080330 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jun 2008. https://www.510kdatabase.net/k080888/ 2008-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k080888-modeification-to-iplan-rt-dose-fda-510k.jpg K080888 - MODEIFICATION TO IPLAN RT DOSE K080888 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab AG. Cleared Jun 2008. https://www.510kdatabase.net/k080931/ 2008-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k080931-vidas-c-dificile-toxin-a-b-cdab-assay-fda-510k.jpg K080931 - VIDAS C. DIFICILE TOXIN A & B (CDAB) ASSAY K080931 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jun 2008. https://www.510kdatabase.net/k081091/ 2008-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k081091-precision-500d-rf-x-ray-system-fda-510k.jpg K081091 - PRECISION 500D R&F X-RAY SYSTEM K081091 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Jun 2008. https://www.510kdatabase.net/k081297/ 2008-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k081297-vertex-reconstruction-system-fda-510k.jpg K081297 - VERTEX RECONSTRUCTION SYSTEM K081297 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Jun 2008. https://www.510kdatabase.net/k081427/ 2008-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k081427-browne-opa-test-strip-fda-510k.jpg K081427 - BROWNE OPA TEST STRIP K081427 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Jun 2008. https://www.510kdatabase.net/k081482/ 2008-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k081482-csbp-001a-body-organ-perfusion-system-fda-510k.jpg K081482 - CSBP-001A BODY ORGAN PERFUSION SYSTEM K081482 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Jun 2008. https://www.510kdatabase.net/k081152/ 2008-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k081152-t2-femoral-nail-fda-510k.jpg K081152 - T2 FEMORAL NAIL K081152 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jun 2008. https://www.510kdatabase.net/k072852/ 2008-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k072852-sl-plus-standard-and-lateral-hip-stems-fda-510k.jpg K072852 - SL-PLUS STANDARD AND LATERAL HIP STEMS K072852 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jun 2008. https://www.510kdatabase.net/k073501/ 2008-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k073501-roche-elecsys-toxo-igg-test-system-fda-510k.jpg K073501 - ROCHE ELECSYS TOXO IGG TEST SYSTEM, ROCHE ELECSYS PRECICONTROL TOXO IGG K073501 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jun 2008. https://www.510kdatabase.net/k080678/ 2008-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k080678-uni-knee-20-fda-510k.jpg K080678 - UNI-KNEE 2.0 K080678 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Jun 2008. https://www.510kdatabase.net/k081065/ 2008-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k081065-aplio-xg-diagnostic-ultrasound-system-fda-510k.jpg K081065 - APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A, VERSION 2.2 K081065 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Jun 2008. https://www.510kdatabase.net/k071597/ 2008-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k071597-dimension-vista-r-afp-flexr-reagent-fda-510k.jpg K071597 - DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600 K071597 is a FDA 510(k) cleared immunology medical device. Manufacturer: Dade Behring, Inc.. Cleared Jun 2008. https://www.510kdatabase.net/k081311/ 2008-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k081311-powerport-implanted-port-with-groshong-fda-510k.jpg K081311 - POWERPORT IMPLANTED PORT WITH GROSHONG CATHETER K081311 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jun 2008. https://www.510kdatabase.net/k081426/ 2008-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k081426-nexstar-liftoff-pet-application-fda-510k.jpg K081426 - NEXSTAR LIFTOFF PET APPLICATION SOFTWARE SUITE K081426 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Jun 2008. https://www.510kdatabase.net/k081044/ 2008-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k081044-rejuvenate-modular-hip-system-fda-510k.jpg K081044 - REJUVENATE MODULAR HIP SYSTEM K081044 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jun 2008. https://www.510kdatabase.net/k081022/ 2008-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k081022-somatom-definition-model-asas-fda-510k.jpg K081022 - SOMATOM DEFINITION, MODEL AS/AS+ K081022 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 2008. https://www.510kdatabase.net/k072178/ 2008-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k072178-athena-multi-lyte-hsv-1-2-igg-test-fda-510k.jpg K072178 - ATHENA MULTI-LYTE HSV 1 & 2 IGG TEST SYSTEM K072178 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared May 2008. https://www.510kdatabase.net/k081069/ 2008-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k081069-gore-infinit-mesh-fda-510k.jpg K081069 - GORE INFINIT MESH K081069 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared May 2008. https://www.510kdatabase.net/k081278/ 2008-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k081278-omega-3-trochanteric-stabilizing-plate-fda-510k.jpg K081278 - OMEGA 3 TROCHANTERIC STABILIZING PLATE K081278 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared May 2008. https://www.510kdatabase.net/k073244/ 2008-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k073244-verify-self-contained-biological-fda-510k.jpg K073244 - VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR FOR VH202 GASEOUS STERILIZATION PROCESSES K073244 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared May 2008. https://www.510kdatabase.net/k081045/ 2008-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k081045-destination-renal-guiding-sheath-fda-510k.jpg K081045 - DESTINATION RENAL GUIDING SHEATH K081045 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared May 2008. https://www.510kdatabase.net/k081195/ 2008-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k081195-revere-uniplanar-screws-fda-510k.jpg K081195 - REVERE UNIPLANAR SCREWS K081195 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared May 2008. https://www.510kdatabase.net/k081320/ 2008-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k081320-dc-3-dc-3t-diagnostic-ultrasound-system-fda-510k.jpg K081320 - DC-3, DC-3T DIAGNOSTIC ULTRASOUND SYSTEM K081320 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared May 2008. https://www.510kdatabase.net/k080522/ 2008-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k080522-synthes-35-mm-lcp-distal-tibia-t-plates-fda-510k.jpg K080522 - SYNTHES 3.5 MM LCP DISTAL TIBIA T PLATES K080522 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared May 2008. https://www.510kdatabase.net/k080869/ 2008-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k080869-access-toxo-igg-access-toxo-igg-fda-510k.jpg K080869 - ACCESS TOXO IGG, ACCESS TOXO IGG CALIBRATORS AND ACCESS TOXO IGG QC K080869 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared May 2008. https://www.510kdatabase.net/k081074/ 2008-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k081074-dimension-tshl-flex-reagent-cartridge-fda-510k.jpg K081074 - DIMENSION TSHL FLEX REAGENT CARTRIDGE AND TSH SAMPLE DILUENT WITH MODELS RF 612 AND KD691 K081074 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared May 2008. https://www.510kdatabase.net/k081103/ 2008-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k081103-loci-thyroid-calibrator-with-model-rc610-fda-510k.jpg K081103 - LOCI THYROID CALIBRATOR WITH MODEL RC610 K081103 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared May 2008. https://www.510kdatabase.net/k081046/ 2008-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k081046-pinnacle-destination-peripheral-fda-510k.jpg K081046 - PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH K081046 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared May 2008. https://www.510kdatabase.net/k071889/ 2008-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k071889-datex-ohmeda-s5-critical-care-monitor-fda-510k.jpg K071889 - DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU05 AND L-ICU05A SOFTWARE K071889 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Healthcare. Cleared May 2008. https://www.510kdatabase.net/k080578/ 2008-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k080578-dimension-vista-n-terminal-pro-brain-fda-510k.jpg K080578 - DIMENSION VISTA N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) FLEX REAGENT CARTRIDGE (K6423A), DIMENSION VISTA K080578 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Siemens Healthcare Diagnostics, Inc.. Cleared May 2008. https://www.510kdatabase.net/k071512/ 2008-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k071512-gynecare-prolift-m-pelvic-floor-repair-fda-510k.jpg K071512 - GYNECARE PROLIFT +M* PELVIC FLOOR REPAIR SYSTEMS K071512 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ethicon, Inc.. Cleared May 2008. https://www.510kdatabase.net/k072817/ 2008-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k072817-echelon-titanium-hip-system-fda-510k.jpg K072817 - ECHELON TITANIUM HIP SYSTEM K072817 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared May 2008. https://www.510kdatabase.net/k073285/ 2008-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k073285-peek-prevail-cervical-interbody-device-fda-510k.jpg K073285 - PEEK PREVAIL CERVICAL INTERBODY DEVICE K073285 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared May 2008. https://www.510kdatabase.net/k080227/ 2008-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k080227-accu-chek-360-diabetes-management-system-fda-510k.jpg K080227 - ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM K080227 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Roche Diagnostics Corp.. Cleared May 2008. https://www.510kdatabase.net/k081090/ 2008-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k081090-profemur-lx-58-coated-hip-stem-fda-510k.jpg K081090 - PROFEMUR LX 5/8 COATED HIP STEM K081090 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared May 2008. https://www.510kdatabase.net/k080153/ 2008-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k080153-synthes-usa-curvilinear-distraction-fda-510k.jpg K080153 - SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEM K080153 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared May 2008. https://www.510kdatabase.net/k080977/ 2008-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k080977-3-ccd-endocam-5550-fda-510k.jpg K080977 - 3 CCD ENDOCAM 5550 K080977 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared May 2008. https://www.510kdatabase.net/k081155/ 2008-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k081155-smartset-mv-bone-cement-fda-510k.jpg K081155 - SMARTSET MV BONE CEMENT K081155 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared May 2008. https://www.510kdatabase.net/k081163/ 2008-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k081163-smartset-gmv-gentamicin-bone-cement-fda-510k.jpg K081163 - SMARTSET GMV GENTAMICIN BONE CEMENT K081163 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared May 2008. https://www.510kdatabase.net/k080462/ 2008-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k080462-progenix-dbm-putty-fda-510k.jpg K080462 - PROGENIX DBM PUTTY K080462 is a FDA 510(k) cleared dental medical device. Manufacturer: Medtronic Sofamor Danek. Cleared May 2008. https://www.510kdatabase.net/k080607/ 2008-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k080607-calibrator-for-automated-systems-cfas-fda-510k.jpg K080607 - CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 11355279160 K080607 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared May 2008. https://www.510kdatabase.net/k080750/ 2008-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k080750-browne-rapicide-glutaraldehyde-indicator-fda-510k.jpg K080750 - BROWNE RAPICIDE GLUTARALDEHYDE INDICATOR K080750 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared May 2008. https://www.510kdatabase.net/k080998/ 2008-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k080998-doripenem-10ug-bbl-sensi-disc-fda-510k.jpg K080998 - DORIPENEM 10UG BBL SENSI-DISC K080998 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared May 2008. https://www.510kdatabase.net/k072410/ 2008-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k072410-ksea-clearvision-ii-model-40334120-fda-510k.jpg K072410 - KSEA CLEARVISION II, MODEL 40334120 K072410 is a FDA 510(k) cleared neurology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared May 2008. https://www.510kdatabase.net/k081036/ 2008-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k081036-4d-integrated-treatment-console-with-fda-510k.jpg K081036 - 4D INTEGRATED TREATMENT CONSOLE WITH PATIENT ACCESSORY VERIFICATION SYSTEM (PAVS) K081036 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared May 2008. https://www.510kdatabase.net/k081105/ 2008-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k081105-ge-lightspeed-ct750-hd-lightspeed-80-fda-510k.jpg K081105 - GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0) K081105 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared May 2008. https://www.510kdatabase.net/k080012/ 2008-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k080012-platelia-lyme-igg-assay-fda-510k.jpg K080012 - PLATELIA LYME IGG ASSAY K080012 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bio-Rad. Cleared May 2008. https://www.510kdatabase.net/k080625/ 2008-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k080625-smith-nephew-mis-hip-stem-with-stiktite-fda-510k.jpg K080625 - SMITH & NEPHEW MIS HIP STEM WITH STIKTITE K080625 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared May 2008. https://www.510kdatabase.net/k081082/ 2008-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k081082-u-clip-uni-fire-model-m65-fda-510k.jpg K081082 - U-CLIP UNI-FIRE, MODEL M65 K081082 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medtronic, Inc.. Cleared May 2008. https://www.510kdatabase.net/k080980/ 2008-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k080980-exactech-novation-element-press-fit-fda-510k.jpg K080980 - EXACTECH NOVATION ELEMENT PRESS-FIT FEMORAL STEMS K080980 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared May 2008. https://www.510kdatabase.net/k081007/ 2008-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k081007-zimmer-ml-taper-hip-prosthesis-with-fda-510k.jpg K081007 - ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM K081007 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared May 2008. https://www.510kdatabase.net/k080509/ 2008-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k080509-cardioblate-68000-gnerator-bp2-fda-510k.jpg K080509 - CARDIOBLATE 68000 GNERATOR, BP2 SURGICAL ABLATION DEVICE, LP SURGICAL ABLATION DEVICE, GEMINI-SSURGICAL ABLATION DEVICE K080509 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared May 2008. https://www.510kdatabase.net/k081031/ 2008-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k081031-endoscopic-clip-appliers-with-clip-fda-510k.jpg K081031 - ENDOSCOPIC CLIP APPLIERS WITH CLIP MAGAZINE K081031 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared May 2008. https://www.510kdatabase.net/k073377/ 2008-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k073377-acl-top-with-system-software-v300-fda-510k.jpg K073377 - ACL TOP (WITH SYSTEM SOFTWARE V3.0.0) K073377 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared May 2008. https://www.510kdatabase.net/k081071/ 2008-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k081071-synthes-65mm-midfoot-fusion-bolt-fda-510k.jpg K081071 - SYNTHES 6.5MM MIDFOOT FUSION BOLT K081071 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared May 2008. https://www.510kdatabase.net/k080201/ 2008-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k080201-vitek-2-gram-positive-inducible-fda-510k.jpg K080201 - VITEK 2 GRAM POSITIVE INDUCIBLE CLINDAMYCIN RESISTANCE K080201 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Apr 2008. https://www.510kdatabase.net/k080331/ 2008-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k080331-synthes-craniofacial-plate-and-screw-fda-510k.jpg K080331 - SYNTHES CRANIOFACIAL PLATE AND SCREW SYSTEM K080331 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Apr 2008. https://www.510kdatabase.net/k080429/ 2008-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k080429-modificaton-to-pyramid-4-anterior-fda-510k.jpg K080429 - MODIFICATON TO: PYRAMID +4 ANTERIOR LUMBAR PLATE SYSTEM K080429 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Apr 2008. https://www.510kdatabase.net/k081135/ 2008-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k081135-gemini-condor-fda-510k.jpg K081135 - GEMINI CONDOR K081135 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Apr 2008. https://www.510kdatabase.net/k073168/ 2008-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k073168-aesculap-primeline-container-ltd-fda-510k.jpg K073168 - AESCULAP PRIMELINE CONTAINER LTD. K073168 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Aesculap, Inc.. Cleared Apr 2008. https://www.510kdatabase.net/k080885/ 2008-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k080885-medacta-total-hip-prosthesis-system-fda-510k.jpg K080885 - MEDACTA TOTAL HIP PROSTHESIS SYSTEM - LINE EXTENSION K080885 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Apr 2008. https://www.510kdatabase.net/k071552/ 2008-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k071552-puracol-plus-ag-collagen-microscaffold-fda-510k.jpg K071552 - PURACOL PLUS AG COLLAGEN MICROSCAFFOLD WOUND DRESSING K071552 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medline Industries, Inc.. Cleared Apr 2008. https://www.510kdatabase.net/k073291/ 2008-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k073291-capstone-spinal-system-fda-510k.jpg K073291 - CAPSTONE SPINAL SYSTEM K073291 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Apr 2008. https://www.510kdatabase.net/k080943/ 2008-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k080943-synthes-45-mm-and-65-mm-headless-fda-510k.jpg K080943 - SYNTHES 4.5 MM AND 6.5 MM HEADLESS COMPRESSION SCREWS K080943 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Apr 2008. https://www.510kdatabase.net/k080361/ 2008-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k080361-regenerex-tibial-components-fda-510k.jpg K080361 - REGENEREX TIBIAL COMPONENTS K080361 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Apr 2008. https://www.510kdatabase.net/k072714/ 2008-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k072714-tina-quant-hemoglobin-a1c-gen2-test-fda-510k.jpg K072714 - TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM K072714 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Apr 2008. https://www.510kdatabase.net/k080805/ 2008-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k080805-modification-to-vertex-reconstruction-fda-510k.jpg K080805 - MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM K080805 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Apr 2008. https://www.510kdatabase.net/k080608/ 2008-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k080608-digital-lightbox-fda-510k.jpg K080608 - DIGITAL LIGHTBOX K080608 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab AG. Cleared Apr 2008. https://www.510kdatabase.net/k080927/ 2008-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k080927-brightview-vct-imaging-system-fda-510k.jpg K080927 - BRIGHTVIEW VCT IMAGING SYSTEM K080927 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Apr 2008. https://www.510kdatabase.net/k080083/ 2008-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k080083-intrepid-spinal-system-fda-510k.jpg K080083 - INTREPID SPINAL SYSTEM K080083 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Apr 2008. https://www.510kdatabase.net/k080434/ 2008-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k080434-intertan-chs-locking-plate-system-prox-fda-510k.jpg K080434 - INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW K080434 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Apr 2008. https://www.510kdatabase.net/k080850/ 2008-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k080850-darco-headless-compression-screw-fda-510k.jpg K080850 - DARCO HEADLESS COMPRESSION SCREW K080850 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Apr 2008. https://www.510kdatabase.net/k080410/ 2008-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k080410-karl-storz-scbconmed-esu-interface-fda-510k.jpg K080410 - KARL STORZ SCB/CONMED ESU INTERFACE MODULE, MODEL 20091522 K080410 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Apr 2008. https://www.510kdatabase.net/k080663/ 2008-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k080663-profemur-lx-revision-58-coated-hip-stem-fda-510k.jpg K080663 - PROFEMUR LX REVISION 5/8 COATED HIP STEM K080663 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Apr 2008. https://www.510kdatabase.net/k080192/ 2008-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k080192-hypervisor-vi-central-monitoring-fda-510k.jpg K080192 - HYPERVISOR VI CENTRAL MONITORING SYSTEM (INCLUDING TMS) K080192 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Apr 2008. https://www.510kdatabase.net/k080753/ 2008-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k080753-aesculap-endoscopic-clip-sytem-fda-510k.jpg K080753 - AESCULAP ENDOSCOPIC CLIP SYTEM K080753 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Apr 2008. https://www.510kdatabase.net/k073550/ 2008-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k073550-prefense-edns-9000-series-nurse-fda-510k.jpg K073550 - PREFENSE EDNS-9000 SERIES NURSE CENTRAL STATION K073550 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Mar 2008. https://www.510kdatabase.net/k061907/ 2008-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k061907-modification-to-datex-ohmeda-s5-fda-510k.jpg K061907 - MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES K061907 is a FDA 510(k) cleared neurology medical device. Manufacturer: Ge Healthcare. Cleared Mar 2008. https://www.510kdatabase.net/k072730/ 2008-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k072730-friadent-cercon-and-ankylos-cercon-fda-510k.jpg K072730 - FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTS K072730 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Mar 2008. https://www.510kdatabase.net/k080170/ 2008-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k080170-agento-ic-silver-coated-endotracheal-fda-510k.jpg K080170 - AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE (IHVLP) K080170 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 2008. https://www.510kdatabase.net/k080183/ 2008-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k080183-control-set-dat-i-contrl-set-dat-ii-fda-510k.jpg K080183 - CONTROL SET DAT I, CONTRL SET DAT II, CONTROL SET DAT III, CONTROL SET AMPHETAMINE 1000 AND CONTROL SET AMPHETAMINE 500 K080183 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Mar 2008. https://www.510kdatabase.net/k080157/ 2008-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k080157-dash-2500-patient-monitor-fda-510k.jpg K080157 - DASH 2500 PATIENT MONITOR K080157 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Mar 2008. https://www.510kdatabase.net/k063684/ 2008-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k063684-cobas-lithium-fda-510k.jpg K063684 - COBAS LITHIUM K063684 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Mar 2008. https://www.510kdatabase.net/k080640/ 2008-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k080640-m5-diagnostic-ultrasound-system-fda-510k.jpg K080640 - M5 DIAGNOSTIC ULTRASOUND SYSTEM K080640 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Mar 2008. https://www.510kdatabase.net/k072723/ 2008-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k072723-respironics-golox-fda-510k.jpg K072723 - RESPIRONICS GOLOX K072723 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Mar 2008. https://www.510kdatabase.net/k080109/ 2008-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k080109-synthes-usa-modular-blade-plate-system-fda-510k.jpg K080109 - SYNTHES (USA) MODULAR BLADE PLATE SYSTEM K080109 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Mar 2008. https://www.510kdatabase.net/k080204/ 2008-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k080204-vanguard-knee-system-titanium-femoral-fda-510k.jpg K080204 - VANGUARD KNEE SYSTEM TITANIUM FEMORAL COMPONENTS K080204 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Mar 2008. https://www.510kdatabase.net/k080563/ 2008-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k080563-runthrough-ns-extension-wire-fda-510k.jpg K080563 - RUNTHROUGH NS EXTENSION WIRE K080563 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Mar 2008. https://www.510kdatabase.net/k071525/ 2008-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k071525-activated-aspartate-aminotransferase-fda-510k.jpg K071525 - ACTIVATED ASPARTATE AMINOTRANSFERASE K071525 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Mar 2008. https://www.510kdatabase.net/k073718/ 2008-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k073718-medline-gastrostomy-tube-fda-510k.jpg K073718 - MEDLINE GASTROSTOMY TUBE K073718 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medline Industries, Inc.. Cleared Mar 2008. https://www.510kdatabase.net/k080166/ 2008-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k080166-access-estradiol-calibrators-on-the-fda-510k.jpg K080166 - ACCESS ESTRADIOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33545 K080166 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Mar 2008. https://www.510kdatabase.net/k080291/ 2008-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k080291-intuitive-surgical-da-vinci-endoscopic-fda-510k.jpg K080291 - INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENTS AND CONTROL SYSTEM AND ENDOWRIST STABILIZER K080291 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Mar 2008. https://www.510kdatabase.net/k080667/ 2008-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k080667-variax-distal-radius-torx-screws-fda-510k.jpg K080667 - VARIAX DISTAL RADIUS TORX SCREWS K080667 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Mar 2008. https://www.510kdatabase.net/k080211/ 2008-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k080211-model-tsx-101ahi-aquilion-3264-sp-ct-fda-510k.jpg K080211 - MODEL TSX-101A/H/I AQUILION 32/64 SP CT SYSTEM K080211 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Mar 2008. https://www.510kdatabase.net/k073324/ 2008-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k073324-medtronic-profile-3d-annuloplasty-ring-fda-510k.jpg K073324 - MEDTRONIC PROFILE 3D ANNULOPLASTY RING, MODEL 680R K073324 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Mar 2008. https://www.510kdatabase.net/k073604/ 2008-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k073604-dimension-exl-with-lm-clinical-fda-510k.jpg K073604 - DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD K073604 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Mar 2008. https://www.510kdatabase.net/k073623/ 2008-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k073623-atlantis-018-peripheral-imaging-catheter-fda-510k.jpg K073623 - ATLANTIS 018 PERIPHERAL IMAGING CATHETER K073623 is a FDA 510(k) cleared radiology medical device. Manufacturer: Boston Scientific Corp. Cleared Mar 2008. https://www.510kdatabase.net/k073538/ 2008-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k073538-dual-chamber-tpn-container-fda-510k.jpg K073538 - DUAL CHAMBER TPN CONTAINER K073538 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Mar 2008. https://www.510kdatabase.net/k080272/ 2008-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k080272-atlantis-pvimaging-catheter-model-fda-510k.jpg K080272 - ATLANTIS PVIMAGING CATHETER, MODEL H749364560 K080272 is a FDA 510(k) cleared radiology medical device. Manufacturer: Boston Scientific Corp. Cleared Mar 2008. https://www.510kdatabase.net/k072212/ 2008-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k072212-jet-x-bar-system-clamps-bars-and-posts-fda-510k.jpg K072212 - JET-X BAR SYSTEM CLAMPS, BARS AND POSTS-MR SAFE K072212 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Mar 2008. https://www.510kdatabase.net/k072719/ 2008-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k072719-convoy-advanced-delivery-sheath-fda-510k.jpg K072719 - CONVOY ADVANCED DELIVERY SHEATH K072719 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Mar 2008. https://www.510kdatabase.net/k073286/ 2008-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k073286-gender-solutions-natural-knee-flex-fda-510k.jpg K073286 - GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM K073286 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Mar 2008. https://www.510kdatabase.net/k080415/ 2008-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k080415-device-modification-to-pinnacle-fda-510k.jpg K080415 - DEVICE MODIFICATION TO PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH K080415 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Mar 2008. https://www.510kdatabase.net/k073277/ 2008-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k073277-roche-creactive-protein-latex-fda-510k.jpg K073277 - ROCHE-CREACTIVE PROTEIN (LATEX) K073277 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Mar 2008. https://www.510kdatabase.net/k080155/ 2008-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k080155-modification-tointuitive-surgical-fda-510k.jpg K080155 - MODIFICATION TO:INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM K080155 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Mar 2008. https://www.510kdatabase.net/k071244/ 2008-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k071244-medline-single-patient-use-blood-fda-510k.jpg K071244 - MEDLINE SINGLE PATIENT USE BLOOD PRESSURE CUFF K071244 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medline Industries, Inc.. Cleared Mar 2008. https://www.510kdatabase.net/k072944/ 2008-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k072944-quanta-lite-ccp31-iggiga-elisa-fda-510k.jpg K072944 - QUANTA LITE CCP3.1 IGG/IGA ELISA K072944 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Mar 2008. https://www.510kdatabase.net/k073589/ 2008-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k073589-bd-phoenix-automated-microbiology-fda-510k.jpg K073589 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DAPTOMYCIN (0.0313-16 UG/ML) STEPTOCOCCUS ID/AST OR AST ONLY PHOENIX PANELS K073589 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Mar 2008. https://www.510kdatabase.net/k073509/ 2008-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k073509-twinfix-pk-fp-suture-anchor-fda-510k.jpg K073509 - TWINFIX PK FP SUTURE ANCHOR K073509 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Mar 2008. https://www.510kdatabase.net/k073627/ 2008-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k073627-flexor-evac-aspiration-catheter-fda-510k.jpg K073627 - FLEXOR EVAC ASPIRATION CATHETER K073627 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Mar 2008. https://www.510kdatabase.net/k073091/ 2008-02-29 monthly 0.5 https://www.510kdatabase.net/og-image/k073091-vidas-nt-probnp-assay-model-30-449-fda-510k.jpg K073091 - VIDAS NT-PROBNP ASSAY, MODEL: 30 449 K073091 is a FDA 510(k) cleared chemistry medical device. Manufacturer: bioMerieux, Inc.. Cleared Feb 2008. https://www.510kdatabase.net/k073402/ 2008-02-29 monthly 0.5 https://www.510kdatabase.net/og-image/k073402-synthes-olecranon-osteotomy-nailing-fda-510k.jpg K073402 - SYNTHES OLECRANON OSTEOTOMY NAILING SYSTEM K073402 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Feb 2008. https://www.510kdatabase.net/k073688/ 2008-02-29 monthly 0.5 https://www.510kdatabase.net/og-image/k073688-equinoxe-reverse-shoulder-system-fda-510k.jpg K073688 - EQUINOXE REVERSE SHOULDER SYSTEM FRACTURE HUMERAL ADAPTER TRAY AND LOCKING SCREW K073688 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Feb 2008. https://www.510kdatabase.net/k072211/ 2008-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k072211-intuitive-surgical-instrument-and-fda-510k.jpg K072211 - INTUITIVE SURGICAL INSTRUMENT AND ACCESSORIES STERILIZATION TRAYS K072211 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Feb 2008. https://www.510kdatabase.net/k080107/ 2008-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k080107-vitek-2-gram-negative-fda-510k.jpg K080107 - VITEK 2 GRAM NEGATIVE PIPERACILLIN/TAZOBACTAM K080107 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Feb 2008. https://www.510kdatabase.net/k073266/ 2008-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k073266-wallflex-partially-covered-esophageal-fda-510k.jpg K073266 - WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT SYSTEM K073266 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Feb 2008. https://www.510kdatabase.net/k073528/ 2008-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k073528-vena-cava-filter-fda-510k.jpg K073528 - VENA CAVA FILTER K073528 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Feb 2008. https://www.510kdatabase.net/k080147/ 2008-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k080147-elecsys-probnp-ii-calcheck-fda-510k.jpg K080147 - ELECSYS PROBNP II CALCHECK K080147 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Feb 2008. https://www.510kdatabase.net/k080295/ 2008-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k080295-charlotte-claw-35-fda-510k.jpg K080295 - CHARLOTTE CLAW 3.5 K080295 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Feb 2008. https://www.510kdatabase.net/k073138/ 2008-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k073138-cardiq-express-version-20-fda-510k.jpg K073138 - CARDIQ EXPRESS VERSION 2.0 K073138 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Feb 2008. https://www.510kdatabase.net/k073561/ 2008-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k073561-dimension-vista-system-immunoglobulin-fda-510k.jpg K073561 - DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR K073561 is a FDA 510(k) cleared immunology medical device. Manufacturer: Dade Behring, Inc.. Cleared Feb 2008. https://www.510kdatabase.net/k080342/ 2008-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k080342-nihon-kohden-bedside-monitor-model-bsm-fda-510k.jpg K080342 - NIHON KOHDEN BEDSIDE MONITOR, MODEL BSM-6000S SERIES K080342 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Feb 2008. https://www.510kdatabase.net/k073466/ 2008-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k073466-smith-nephew-intradiscal-catheter-system-fda-510k.jpg K073466 - SMITH & NEPHEW INTRADISCAL CATHETER SYSTEM K073466 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Feb 2008. https://www.510kdatabase.net/k073072/ 2008-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k073072-dimension-ahdl-flex-reagent-cartridge-fda-510k.jpg K073072 - DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B K073072 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Feb 2008. https://www.510kdatabase.net/k073460/ 2008-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k073460-synthes-27-mm35-mm-lcp-distal-fibula-fda-510k.jpg K073460 - SYNTHES 2.7 MM/3.5 MM LCP DISTAL FIBULA PLATES K073460 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Feb 2008. https://www.510kdatabase.net/k073570/ 2008-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k073570-depuy-tri-lock-bone-preservation-stem-fda-510k.jpg K073570 - DEPUY TRI-LOCK BONE PRESERVATION STEM K073570 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Feb 2008. https://www.510kdatabase.net/k072733/ 2008-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k072733-3m-espe-adult-crown-fda-510k.jpg K072733 - 3M ESPE ADULT CROWN K072733 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Feb 2008. https://www.510kdatabase.net/k073076/ 2008-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k073076-hoffmann-light-system-fda-510k.jpg K073076 - HOFFMANN LIGHT SYSTEM K073076 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Feb 2008. https://www.510kdatabase.net/k070947/ 2008-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k070947-intuitive-surgical-da-vinci-surgical-fda-510k.jpg K070947 - INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND ENDOWRIST CARDIAC PROBE GRASPER K070947 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Feb 2008. https://www.510kdatabase.net/k073527/ 2008-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k073527-variax-elbow-system-fda-510k.jpg K073527 - VARIAX ELBOW SYSTEM K073527 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Feb 2008. https://www.510kdatabase.net/k073337/ 2008-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k073337-mectacer-biolox-forte-femoral-heads-fda-510k.jpg K073337 - MECTACER BIOLOX FORTE-FEMORAL HEADS K073337 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Feb 2008. https://www.510kdatabase.net/k080111/ 2008-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k080111-arthrex-compression-staple-fda-510k.jpg K080111 - ARTHREX COMPRESSION STAPLE K080111 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Feb 2008. https://www.510kdatabase.net/k073145/ 2008-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k073145-quanta-lite-h-ttg-screen-fda-510k.jpg K073145 - QUANTA LITE H-TTG SCREEN K073145 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Feb 2008. https://www.510kdatabase.net/k072632/ 2008-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k072632-quanta-plex-celiac-igg-profile-fda-510k.jpg K072632 - QUANTA PLEX CELIAC IGG PROFILE K072632 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Feb 2008. https://www.510kdatabase.net/k073149/ 2008-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k073149-meniscal-cinch-fda-510k.jpg K073149 - MENISCAL CINCH K073149 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Arthrex, Inc.. Cleared Feb 2008. https://www.510kdatabase.net/k073290/ 2008-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k073290-artis-zee-and-zeego-fda-510k.jpg K073290 - ARTIS ZEE AND ZEEGO K073290 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 2008. https://www.510kdatabase.net/k073487/ 2008-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k073487-olympus-igm-reagent-fda-510k.jpg K073487 - OLYMPUS IGM REAGENT K073487 is a FDA 510(k) cleared immunology medical device. Manufacturer: Olympus America, Inc.. Cleared Feb 2008. https://www.510kdatabase.net/k073489/ 2008-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k073489-olympus-iga-reagent-fda-510k.jpg K073489 - OLYMPUS IGA REAGENT K073489 is a FDA 510(k) cleared immunology medical device. Manufacturer: Olympus America, Inc.. Cleared Feb 2008. https://www.510kdatabase.net/k073490/ 2008-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k073490-olympus-igg-reagent-fda-510k.jpg K073490 - OLYMPUS IGG REAGENT K073490 is a FDA 510(k) cleared immunology medical device. Manufacturer: Olympus America, Inc.. Cleared Feb 2008. https://www.510kdatabase.net/k072942/ 2008-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k072942-medline-disposable-vaginal-speculum-fda-510k.jpg K072942 - MEDLINE DISPOSABLE VAGINAL SPECULUM K072942 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Medline Industries, Inc.. Cleared Feb 2008. https://www.510kdatabase.net/k080160/ 2008-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k080160-aplio-artida-model-ssh-880cv-fda-510k.jpg K080160 - APLIO ARTIDA, MODEL SSH-880CV DIAGNOSTIC ULTRASOUND SYSTEM K080160 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Feb 2008. https://www.510kdatabase.net/k072627/ 2008-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k072627-intuitive-surgical-da-vinci-and-da-fda-510k.jpg K072627 - INTUITIVE SURGICAL DA VINCI AND DA VINCI S SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS AND ENDOWRIST INTRODUCER K072627 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Feb 2008. https://www.510kdatabase.net/k080071/ 2008-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k080071-sidekick-rail-fixator-fda-510k.jpg K080071 - SIDEKICK RAIL FIXATOR K080071 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Feb 2008. https://www.510kdatabase.net/k062798/ 2008-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k062798-smart-nitinol-self-expanding-stent-fda-510k.jpg K062798 - SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB K062798 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Feb 2008. https://www.510kdatabase.net/k072656/ 2008-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k072656-dynasty-ceramic-femoral-head-fda-510k.jpg K072656 - DYNASTY CERAMIC FEMORAL HEAD K072656 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Feb 2008. https://www.510kdatabase.net/k072437/ 2008-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k072437-elecsys-probnp-ii-precicontrol-cardiac-fda-510k.jpg K072437 - ELECSYS PROBNP II, PRECICONTROL CARDIAC II, PROBNP II CALSET K072437 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Feb 2008. https://www.510kdatabase.net/k072857/ 2008-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k072857-total-hip-prosthesis-system-quadra-s-fda-510k.jpg K072857 - TOTAL HIP PROSTHESIS SYSTEM QUADRA S + COCRMO FEMORAL BALL HEAD + APRICOT K072857 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medacta International S.A.. Cleared Feb 2008. https://www.510kdatabase.net/k072018/ 2008-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k072018-bs-200-chemistry-analyzer-mode-bs-200-fda-510k.jpg K072018 - BS-200 CHEMISTRY ANALYZER, MODE BS-200 K072018 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Feb 2008. https://www.510kdatabase.net/k072920/ 2008-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k072920-handheld-base-unit-fda-510k.jpg K072920 - HANDHELD BASE UNIT K072920 is a FDA 510(k) cleared hematology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jan 2008. https://www.510kdatabase.net/k073413/ 2008-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k073413-depuy-asr-300-acetabular-cup-system-fda-510k.jpg K073413 - DEPUY ASR 300 ACETABULAR CUP SYSTEM K073413 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jan 2008. https://www.510kdatabase.net/k073135/ 2008-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k073135-synthes-usa-hybrid-external-fixator-fda-510k.jpg K073135 - SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS K073135 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jan 2008. https://www.510kdatabase.net/k073676/ 2008-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k073676-depuy-delta-xtend-reverse-shoulder-fda-510k.jpg K073676 - DEPUY DELTA XTEND REVERSE SHOULDER HIGH MOBILITY CUP K073676 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jan 2008. https://www.510kdatabase.net/k072967/ 2008-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k072967-quanta-lite-f-actin-iga-elisa-fda-510k.jpg K072967 - QUANTA LITE F-ACTIN IGA ELISA K072967 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Jan 2008. https://www.510kdatabase.net/k073683/ 2008-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k073683-verify-challenge-packs-version-2-fda-510k.jpg K073683 - VERIFY CHALLENGE PACKS - VERSION 2 K073683 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Jan 2008. https://www.510kdatabase.net/k073529/ 2008-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k073529-depuy-sigma-ps-femoral-components-fda-510k.jpg K073529 - DEPUY SIGMA PS FEMORAL COMPONENTS K073529 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jan 2008. https://www.510kdatabase.net/k073018/ 2008-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k073018-stereotactic-target-positioner-target-fda-510k.jpg K073018 - STEREOTACTIC TARGET POSITIONER, TARGET POSITIONER FOR LEKSELL HEADRING, STEREOTACTIC COUNTERWEIGHT K073018 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab AG. Cleared Jan 2008. https://www.510kdatabase.net/k073406/ 2008-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k073406-vitek-2-gram-negative-fda-510k.jpg K073406 - VITEK 2 GRAM NEGATIVE TRIMETHOPRIM/SULFAMETHOXAZOLE K073406 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jan 2008. https://www.510kdatabase.net/k080038/ 2008-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k080038-vantage-titan-model-mrt-1504s3-fda-510k.jpg K080038 - VANTAGE TITAN, MODEL MRT-1504/S3 K080038 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Jan 2008. https://www.510kdatabase.net/k072970/ 2008-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k072970-patriot-spacers-fda-510k.jpg K072970 - PATRIOT SPACERS K072970 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Jan 2008. https://www.510kdatabase.net/k072991/ 2008-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k072991-patriot-spacers-colonial-acdf-fda-510k.jpg K072991 - PATRIOT SPACERS: COLONIAL ACDF K072991 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Jan 2008. https://www.510kdatabase.net/k071456/ 2008-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k071456-arthrex-prostop-plus-arthroereisis-fda-510k.jpg K071456 - ARTHREX PROSTOP PLUS ARTHROEREISIS SUBTALAR IMPLANT K071456 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jan 2008. https://www.510kdatabase.net/k073090/ 2008-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k073090-recovery-g2-filter-system-femoral-fda-510k.jpg K073090 - RECOVERY G2 FILTER SYSTEM - FEMORAL DELIVERY KIT, MODEL RF-310F K073090 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 2008. https://www.510kdatabase.net/k073433/ 2008-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k073433-bd-phoenix-automated-microbiology-fda-510k.jpg K073433 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN (GN) -128 UG/ML K073433 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Jan 2008. https://www.510kdatabase.net/k073462/ 2008-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k073462-modification-to-dash-3000-4000-5000-fda-510k.jpg K073462 - MODIFICATION TO DASH 3000, 4000, 5000 MONITOR AND ACCESSORIES K073462 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Jan 2008. https://www.510kdatabase.net/k073491/ 2008-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k073491-eeg-1100a-switch-box-fda-510k.jpg K073491 - EEG-1100A SWITCH BOX K073491 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Jan 2008. https://www.510kdatabase.net/k072417/ 2008-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k072417-smith-nephew-mis-hip-stem-fda-510k.jpg K072417 - SMITH & NEPHEW MIS HIP STEM K072417 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jan 2008. https://www.510kdatabase.net/k072265/ 2008-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k072265-progenix-dmb-putty-fda-510k.jpg K072265 - PROGENIX DMB PUTTY K072265 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Jan 2008. https://www.510kdatabase.net/k072367/ 2008-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k072367-repiphysis-limb-salvage-proximal-femur-fda-510k.jpg K072367 - REPIPHYSIS LIMB SALVAGE PROXIMAL FEMUR AND TOTAL FEMUR K072367 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jan 2008. https://www.510kdatabase.net/k072963/ 2008-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k072963-depuy-pinnacle-altrx-acetabular-liners-fda-510k.jpg K072963 - DEPUY PINNACLE ALTRX ACETABULAR LINERS K072963 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jan 2008. https://www.510kdatabase.net/k073472/ 2008-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k073472-vaccess-pta-balloon-dilatation-catheter-fda-510k.jpg K073472 - VACCESS PTA BALLOON DILATATION CATHETER K073472 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 2008. https://www.510kdatabase.net/k072581/ 2008-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k072581-pm-60-pulse-oximeter-fda-510k.jpg K072581 - PM-60 PULSE OXIMETER K072581 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Jan 2008. https://www.510kdatabase.net/k072121/ 2008-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k072121-trabecular-metal-acetabular-revision-fda-510k.jpg K072121 - TRABECULAR METAL ACETABULAR REVISION SYSTEM CEMENTED CONTRAINED LINER K072121 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jan 2008. https://www.510kdatabase.net/k073535/ 2008-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k073535-biofoam-bone-wedge-fda-510k.jpg K073535 - BIOFOAM BONE WEDGE K073535 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jan 2008. https://www.510kdatabase.net/k070665/ 2008-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k070665-lithoskop-fda-510k.jpg K070665 - LITHOSKOP K070665 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 2008. https://www.510kdatabase.net/k073336/ 2008-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k073336-codman-craniotomy-kit-models-26-1229-fda-510k.jpg K073336 - CODMAN CRANIOTOMY KIT, MODELS 26-1229, 26-1230, 26-1231 K073336 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Jan 2008. https://www.510kdatabase.net/k073055/ 2008-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k073055-dimension-enzymatic-creatinine-flex-fda-510k.jpg K073055 - DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH MODEL DF270 K073055 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Jan 2008. https://www.510kdatabase.net/k073517/ 2008-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k073517-h-link-integrated-rod-fda-510k.jpg K073517 - H-LINK INTEGRATED ROD K073517 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Jan 2008. https://www.510kdatabase.net/k073378/ 2007-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k073378-advance-18lp-pta-dilatation-catheter-fda-510k.jpg K073378 - ADVANCE 18LP PTA DILATATION CATHETER K073378 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Dec 2007. https://www.510kdatabase.net/k072485/ 2007-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k072485-artiste-mv-sa-fda-510k.jpg K072485 - ARTISTE MV SA K072485 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Dec 2007. https://www.510kdatabase.net/k072996/ 2007-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k072996-remstar-pro-m-series-cpap-heated-fda-510k.jpg K072996 - REMSTAR PRO M-SERIES CPAP & HEATED HUMIDIFIER SYSTEM K072996 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Dec 2007. https://www.510kdatabase.net/k073367/ 2007-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k073367-hemosil-fibrinogen-c-fda-510k.jpg K073367 - HEMOSIL FIBRINOGEN-C K073367 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Dec 2007. https://www.510kdatabase.net/k072788/ 2007-12-26 monthly 0.5 https://www.510kdatabase.net/og-image/k072788-storz-modulith-lithotripter-slx-f2-f180-fda-510k.jpg K072788 - STORZ MODULITH LITHOTRIPTER SLX-F2-F180 K072788 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Dec 2007. https://www.510kdatabase.net/k062580/ 2007-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k062580-ge-entropy-sensor-refm1038681-and-ge-fda-510k.jpg K062580 - GE ENTROPY SENSOR (REFM1038681) AND GE ENTROPY CABLE (REF M1050784) K062580 is a FDA 510(k) cleared neurology medical device. Manufacturer: Ge Healthcare. Cleared Dec 2007. https://www.510kdatabase.net/k072138/ 2007-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k072138-vidas-c-difficile-toxin-ab-cdab-assay-fda-510k.jpg K072138 - VIDAS C. DIFFICILE TOXIN A&B (CDAB) ASSAY, MODEL: 30 118 K072138 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Dec 2007. https://www.510kdatabase.net/k072965/ 2007-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k072965-dimension-vista-c1-in-fda-510k.jpg K072965 - DIMENSION VISTA C1 IN K072965 is a FDA 510(k) cleared immunology medical device. Manufacturer: Dade Behring, Inc.. Cleared Dec 2007. https://www.510kdatabase.net/k063686/ 2007-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k063686-depuy-lps-distal-femoral-component-fda-510k.jpg K063686 - DEPUY LPS DISTAL FEMORAL COMPONENT K063686 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Dec 2007. https://www.510kdatabase.net/k071187/ 2007-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k071187-microfuse-bone-void-filler-fda-510k.jpg K071187 - MICROFUSE BONE VOID FILLER K071187 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Dec 2007. https://www.510kdatabase.net/k072976/ 2007-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k072976-model-250cx-series-maternalfetal-monitor-fda-510k.jpg K072976 - MODEL 250CX SERIES MATERNAL/FETAL MONITOR K072976 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ge Healthcare. Cleared Dec 2007. https://www.510kdatabase.net/k073175/ 2007-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k073175-journey-unicondylar-femoral-implant-fda-510k.jpg K073175 - JOURNEY UNICONDYLAR FEMORAL IMPLANT K073175 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Dec 2007. https://www.510kdatabase.net/k073259/ 2007-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k073259-xidf-100ab1-image-processor-fda-510k.jpg K073259 - XIDF-100A/B1 IMAGE PROCESSOR K073259 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Dec 2007. https://www.510kdatabase.net/k073325/ 2007-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k073325-legion-porous-primary-fda-510k.jpg K073325 - LEGION POROUS PRIMARY K073325 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Dec 2007. https://www.510kdatabase.net/k073020/ 2007-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k073020-eclipse-treatment-planning-system-fda-510k.jpg K073020 - ECLIPSE TREATMENT PLANNING SYSTEM K073020 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Dec 2007. https://www.510kdatabase.net/k073423/ 2007-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k073423-mri-powerport-implanted-port-with-96-fda-510k.jpg K073423 - MRI POWERPORT IMPLANTED PORT WITH 9.6 FR SILICONE CATHETER K073423 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 2007. https://www.510kdatabase.net/k072676/ 2007-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k072676-acuson-x300-ultrasound-system-fda-510k.jpg K072676 - ACUSON X300 ULTRASOUND SYSTEM K072676 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Dec 2007. https://www.510kdatabase.net/k072758/ 2007-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k072758-synthes-usa-20mm-titanium-t-plate-fda-510k.jpg K072758 - SYNTHES (USA) 2.0MM TITANIUM T-PLATE K072758 is a FDA 510(k) cleared neurology medical device. Manufacturer: Synthes (Usa). Cleared Dec 2007. https://www.510kdatabase.net/k073297/ 2007-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k073297-ge-logiq-p6-fda-510k.jpg K073297 - GE LOGIQ P6 K073297 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Dec 2007. https://www.510kdatabase.net/k073186/ 2007-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k073186-synthes-35mm-lcp-clavicle-plate-system-fda-510k.jpg K073186 - SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM K073186 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Dec 2007. https://www.510kdatabase.net/k063243/ 2007-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k063243-vidas-troponin-i-ultra-tniu-assay-fda-510k.jpg K063243 - VIDAS TROPONIN I ULTRA (TNIU) ASSAY, MODEL 30 448 K063243 is a FDA 510(k) cleared chemistry medical device. Manufacturer: bioMerieux, Inc.. Cleared Dec 2007. https://www.510kdatabase.net/k072476/ 2007-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k072476-through-the-peg-ttp-jejunostomy-tube-kit-fda-510k.jpg K072476 - THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT K072476 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared Dec 2007. https://www.510kdatabase.net/k072552/ 2007-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k072552-merit-medical-systems-inc-guide-wire-fda-510k.jpg K072552 - MERIT MEDICAL SYSTEMS, INC., GUIDE WIRE TORQUE DEVICE K072552 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Dec 2007. https://www.510kdatabase.net/k072832/ 2007-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k072832-anterolateral-and-medial-locking-fda-510k.jpg K072832 - ANTEROLATERAL AND MEDIAL LOCKING PLATING SYSTEM K072832 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Dec 2007. https://www.510kdatabase.net/k072625/ 2007-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k072625-turbo-ject-peripherally-inserted-fda-510k.jpg K072625 - TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER (PICC) K072625 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cook, Inc.. Cleared Dec 2007. https://www.510kdatabase.net/k073172/ 2007-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k073172-beacon-stabilization-system-fda-510k.jpg K073172 - BEACON STABILIZATION SYSTEM K073172 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Dec 2007. https://www.510kdatabase.net/k072717/ 2007-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k072717-dimension-vista-system-bilirubin-fda-510k.jpg K072717 - DIMENSION VISTA SYSTEM BILIRUBIN CALIBRATOR, MODEL KC210 K072717 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Dec 2007. https://www.510kdatabase.net/k071942/ 2007-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k071942-modification-to-vertex-reconstruction-fda-510k.jpg K071942 - MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM K071942 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Dec 2007. https://www.510kdatabase.net/k072510/ 2007-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k072510-verify-v-pro-chemical-indicator-fda-510k.jpg K072510 - VERIFY V-PRO CHEMICAL INDICATOR, VERSIONS 1 AND 2 K072510 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Dec 2007. https://www.510kdatabase.net/k073083/ 2007-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k073083-vitek-2-gram-negative-piperacillin-fda-510k.jpg K073083 - VITEK 2 GRAM NEGATIVE PIPERACILLIN K073083 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Dec 2007. https://www.510kdatabase.net/k070558/ 2007-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k070558-bardex-lubri-sil-and-bardex-lubri-sil-fda-510k.jpg K070558 - BARDEX LUBRI-SIL AND BARDEX LUBRI-SIL I.C. ANTI-INFECTIVE ALL-SILICONE FOLEY CATHETERS K070558 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 2007. https://www.510kdatabase.net/k070582/ 2007-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k070582-bardex-all-silicone-bardex-lubri-sil-fda-510k.jpg K070582 - BARDEX ALL-SILICONE, BARDEX LUBRI-SIL, AND BARDEX LUBRI-SIL I.C. TEMPERATURE-SENSING FOLEY CATHETERS K070582 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 2007. https://www.510kdatabase.net/k071219/ 2007-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k071219-athena-multi-lyte-gbm-test-system-fda-510k.jpg K071219 - ATHENA MULTI-LYTE GBM TEST SYSTEM K071219 is a FDA 510(k) cleared immunology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Dec 2007. https://www.510kdatabase.net/k072330/ 2007-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k072330-controlled-delivery-for-osteoplasty-fda-510k.jpg K072330 - CONTROLLED DELIVERY FOR OSTEOPLASTY (CDO SYSTEM) AND GRAFT PREPARATION SYSTEM K072330 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Biomet, Inc.. Cleared Dec 2007. https://www.510kdatabase.net/k072531/ 2007-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k072531-legion-stem-with-holes-fda-510k.jpg K072531 - LEGION STEM WITH HOLES K072531 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Dec 2007. https://www.510kdatabase.net/k072346/ 2007-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k072346-pm-7000-patient-monitor-fda-510k.jpg K072346 - PM-7000 PATIENT MONITOR K072346 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Nov 2007. https://www.510kdatabase.net/k072843/ 2007-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k072843-yg-125t-and-yg-135t-nasal-adapter-fda-510k.jpg K072843 - YG-125T AND YG-135T NASAL ADAPTER K072843 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Nov 2007. https://www.510kdatabase.net/k073203/ 2007-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k073203-carescape-v100-fda-510k.jpg K073203 - CARESCAPE V100 K073203 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Nov 2007. https://www.510kdatabase.net/k072578/ 2007-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k072578-synthes-usa-epoca-shoulder-prosthesis-fda-510k.jpg K072578 - SYNTHES (USA) EPOCA SHOULDER PROSTHESIS SYSTEM K072578 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Nov 2007. https://www.510kdatabase.net/k071406/ 2007-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k071406-autosuture-endo-clip-iii-5-mm-clip-fda-510k.jpg K071406 - AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIER K071406 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Nov 2007. https://www.510kdatabase.net/k071641/ 2007-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k071641-reveal-xt-fda-510k.jpg K071641 - REVEAL XT K071641 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Nov 2007. https://www.510kdatabase.net/k071655/ 2007-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k071655-reveal-dx-insertable-cardiac-monitor-fda-510k.jpg K071655 - REVEAL DX INSERTABLE CARDIAC MONITOR, REVEAL PATIENT ASSISTANT, MODEL(S) 9528,9538 K071655 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Nov 2007. https://www.510kdatabase.net/k072619/ 2007-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k072619-nexgen-complete-knee-solution-lps-flex-fda-510k.jpg K072619 - NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX AND KNEE GENDER SOLUTIONS FEMALE (GSF) POROUS FEMORAL COMPONENTS K072619 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Nov 2007. https://www.510kdatabase.net/k073081/ 2007-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k073081-jet-software-for-excelart-vantage-fda-510k.jpg K073081 - JET SOFTWARE FOR EXCELART VANTAGE ATLAS-Z AND ATLAS-X K073081 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Nov 2007. https://www.510kdatabase.net/k070691/ 2007-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k070691-bbl-chromagar-0157-fda-510k.jpg K070691 - BBL CHROMAGAR 0157 K070691 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Nov 2007. https://www.510kdatabase.net/k072556/ 2007-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k072556-hemostasis-valve-fda-510k.jpg K072556 - HEMOSTASIS VALVE K072556 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Nov 2007. https://www.510kdatabase.net/k072858/ 2007-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k072858-tc-plus-primary-knee-system-fda-510k.jpg K072858 - TC-PLUS PRIMARY KNEE SYSTEM K072858 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Nov 2007. https://www.510kdatabase.net/k072986/ 2007-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k072986-integradweb-pacs-system-fda-510k.jpg K072986 - INTEGRADWEB PACS SYSTEM K072986 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Nov 2007. https://www.510kdatabase.net/k073035/ 2007-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k073035-prelude-and-prelude-pro-sheath-fda-510k.jpg K073035 - PRELUDE AND PRELUDE PRO SHEATH INTRODUCERS K073035 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Nov 2007. https://www.510kdatabase.net/k071535/ 2007-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k071535-biolox-delta-ceramic-femoral-head-fda-510k.jpg K071535 - BIOLOX DELTA CERAMIC FEMORAL HEAD K071535 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Nov 2007. https://www.510kdatabase.net/k072502/ 2007-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k072502-modification-to-muse-cardiology-fda-510k.jpg K072502 - MODIFICATION TO: MUSE CARDIOLOGY INFORMATION SYSTEM K072502 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Nov 2007. https://www.510kdatabase.net/k072818/ 2007-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k072818-peri-loc-periartricular-lck-pit-sys-fda-510k.jpg K072818 - PERI-LOC PERIARTRICULAR LCK PIT SYS-PROX FEM PLATES/SCREWS.CALBE ACCESS K072818 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Nov 2007. https://www.510kdatabase.net/k072695/ 2007-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k072695-vitek-2-gram-positive-tigecycline-fda-510k.jpg K072695 - VITEK 2 GRAM POSITIVE TIGECYCLINE K072695 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Nov 2007. https://www.510kdatabase.net/k072952/ 2007-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k072952-ge-echopac-fda-510k.jpg K072952 - GE ECHOPAC K072952 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Nov 2007. https://www.510kdatabase.net/k073133/ 2007-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k073133-interstitial-needles-fda-510k.jpg K073133 - INTERSTITIAL NEEDLES K073133 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Nov 2007. https://www.510kdatabase.net/k073165/ 2007-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k073165-drad-3000e-radrex-i-fda-510k.jpg K073165 - DRAD-3000E, RADREX-I K073165 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Nov 2007. https://www.510kdatabase.net/k063733/ 2007-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k063733-resolve-biliary-drainage-catheter-fda-510k.jpg K063733 - RESOLVE BILIARY DRAINAGE CATHETER K063733 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Nov 2007. https://www.510kdatabase.net/k071895/ 2007-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k071895-verify-275-degree-f-3-10-indicator-fda-510k.jpg K071895 - VERIFY 275 DEGREE F. 3-10 INDICATOR K071895 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Nov 2007. https://www.510kdatabase.net/k072549/ 2007-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k072549-titanium-powerport-isp-implanted-port-fda-510k.jpg K072549 - TITANIUM POWERPORT ISP IMPLANTED PORT WITH 6 FR CHRONOFLEX POLYURETHANE CATHETER K072549 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 2007. https://www.510kdatabase.net/k071224/ 2007-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k071224-dimension-vista-vitamin-b12-and-folate-fda-510k.jpg K071224 - DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDGES AND LOCI 4 CALIBRATOR K071224 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Nov 2007. https://www.510kdatabase.net/k072786/ 2007-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k072786-acuson-s2000-ultrasound-system-fda-510k.jpg K072786 - ACUSON S2000 ULTRASOUND SYSTEM K072786 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2007. https://www.510kdatabase.net/k062607/ 2007-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k062607-polygraft-bgs-fda-510k.jpg K062607 - POLYGRAFT BGS K062607 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Nov 2007. https://www.510kdatabase.net/k071059/ 2007-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k071059-depuy-spa-porous-coated-proximal-sleeve-fda-510k.jpg K071059 - DEPUY SPA POROUS COATED PROXIMAL SLEEVE K071059 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Nov 2007. https://www.510kdatabase.net/k071760/ 2007-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k071760-modification-to-eclipse-treatment-fda-510k.jpg K071760 - MODIFICATION TO: ECLIPSE TREATMENT PLANNING SYSTEM K071760 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Nov 2007. https://www.510kdatabase.net/k071813/ 2007-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k071813-mastergraft-putty-fda-510k.jpg K071813 - MASTERGRAFT PUTTY K071813 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Nov 2007. https://www.510kdatabase.net/k072378/ 2007-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k072378-prowick-antimicrobial-postoperative-fda-510k.jpg K072378 - PROWICK ANTIMICROBIAL POSTOPERATIVE WOUND DRESSING, SHOULDER AND KNEE, MODELS AR-1625, AR-1626 K072378 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Arthrex, Inc.. Cleared Nov 2007. https://www.510kdatabase.net/k072724/ 2007-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k072724-cxi-support-catheter-fda-510k.jpg K072724 - CXI SUPPORT CATHETER K072724 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Nov 2007. https://www.510kdatabase.net/k072916/ 2007-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k072916-trilogy-system-with-rapidarc-fda-510k.jpg K072916 - TRILOGY SYSTEM WITH RAPIDARC K072916 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Nov 2007. https://www.510kdatabase.net/k062264/ 2007-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k062264-complete-se-self-expanding-biliary-fda-510k.jpg K062264 - COMPLETE SE SELF EXPANDING BILIARY STENT SYSTEM K062264 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medtronic Vascular. Cleared Nov 2007. https://www.510kdatabase.net/k071957/ 2007-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k071957-pinnacle-pelvic-floor-repair-kits-fda-510k.jpg K071957 - PINNACLE PELVIC FLOOR REPAIR KITS K071957 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Boston Scientific Corp. Cleared Nov 2007. https://www.510kdatabase.net/k072240/ 2007-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k072240-gunther-tulip-vena-cava-filter-fda-510k.jpg K072240 - GUNTHER TULIP VENA CAVA FILTER K072240 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Nov 2007. https://www.510kdatabase.net/k072247/ 2007-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k072247-sterican-hypodermic-needles-fda-510k.jpg K072247 - STERICAN HYPODERMIC NEEDLES K072247 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Nov 2007. https://www.510kdatabase.net/k072423/ 2007-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k072423-45mm-locking-broad-narrow-compression-fda-510k.jpg K072423 - 4.5MM LOCKING BROAD & NARROW COMPRESSION PLATES, 4.5MM & 5.5MM CORTICAL & CANCELLOUS LOCKING SCREWS, RESPECTIVELY. K072423 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Nov 2007. https://www.510kdatabase.net/k071365/ 2007-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k071365-agento-ic-silver-coated-endotracheal-fda-510k.jpg K071365 - AGENTO I.C. SILVER-COATED ENDOTRACHEAL TUBE K071365 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 2007. https://www.510kdatabase.net/k072576/ 2007-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k072576-clearlink-antimicrobial-luer-activated-fda-510k.jpg K072576 - CLEARLINK ANTIMICROBIAL LUER ACTIVATED DEVICE (LAD) AND EXTENSION SETS WITH THE CLEARLINK ANTIMICROBIAL LUER ACTIVATED K072576 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Nov 2007. https://www.510kdatabase.net/k070799/ 2007-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k070799-modularis-variostar-fda-510k.jpg K070799 - MODULARIS VARIOSTAR K070799 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2007. https://www.510kdatabase.net/k071416/ 2007-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k071416-pyramid-4-anterior-lumbar-spine-plate-fda-510k.jpg K071416 - PYRAMID +4 ANTERIOR LUMBAR SPINE PLATE SYSTEM K071416 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Nov 2007. https://www.510kdatabase.net/k072215/ 2007-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k072215-titanium-powerport-isp-implanted-port-fda-510k.jpg K072215 - TITANIUM POWERPORT ISP IMPLANTED PORT K072215 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 2007. https://www.510kdatabase.net/k072693/ 2007-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k072693-csnp-001a-neuro-package-fda-510k.jpg K072693 - CSNP-001A NEURO PACKAGE K072693 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Nov 2007. https://www.510kdatabase.net/k072990/ 2007-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k072990-guardwire-temporary-occlusion-and-fda-510k.jpg K072990 - GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM- CAROTID K072990 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared Oct 2007. https://www.510kdatabase.net/k072567/ 2007-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k072567-symbia-e-model-10275879-fda-510k.jpg K072567 - SYMBIA-E, MODEL 10275879 K072567 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 2007. https://www.510kdatabase.net/k072506/ 2007-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k072506-exactrac-55-fda-510k.jpg K072506 - EXACTRAC 5.5 K072506 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab AG. Cleared Oct 2007. https://www.510kdatabase.net/k072612/ 2007-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k072612-access-immunoassay-systems-br-monitor-fda-510k.jpg K072612 - ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODEL(S) 387620,AND 387647 K072612 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Oct 2007. https://www.510kdatabase.net/k072083/ 2007-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k072083-small-fragment-locking-plating-system-fda-510k.jpg K072083 - SMALL FRAGMENT LOCKING PLATING SYSTEM K072083 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Oct 2007. https://www.510kdatabase.net/k072826/ 2007-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k072826-aplio-artida-diagnostic-ultrasound-fda-510k.jpg K072826 - APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM K072826 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Oct 2007. https://www.510kdatabase.net/k071046/ 2007-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k071046-synthes-chronos-composite-fda-510k.jpg K071046 - SYNTHES CHRONOS COMPOSITE K071046 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Oct 2007. https://www.510kdatabase.net/k072824/ 2007-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k072824-fox-sv-pta-catheter-fda-510k.jpg K072824 - FOX SV PTA CATHETER K072824 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Laboratories. Cleared Oct 2007. https://www.510kdatabase.net/k071931/ 2007-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k071931-codman-disposable-perforator-models-26-fda-510k.jpg K071931 - CODMAN DISPOSABLE PERFORATOR, MODEL(S) 26-1222, 26-1223 K071931 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Oct 2007. https://www.510kdatabase.net/k072235/ 2007-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k072235-pm-50-pulse-oximeter-and-vs-800-vital-fda-510k.jpg K072235 - PM-50 PULSE OXIMETER AND VS-800 VITAL SIGNS MONITOR K072235 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Oct 2007. https://www.510kdatabase.net/k072638/ 2007-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k072638-rochehitachi-urinarycsf-protein-with-fda-510k.jpg K072638 - ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801 K072638 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Oct 2007. https://www.510kdatabase.net/k072020/ 2007-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k072020-restoration-adm-system-fda-510k.jpg K072020 - RESTORATION ADM SYSTEM K072020 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Oct 2007. https://www.510kdatabase.net/k072046/ 2007-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k072046-exactrac-3rd-party-exactrac-x-ray-6d-fda-510k.jpg K072046 - EXACTRAC 3RD PARTY, EXACTRAC X-RAY 6D 3RD PARTY, EXACTRAC OEM K072046 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab AG. Cleared Oct 2007. https://www.510kdatabase.net/k072435/ 2007-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k072435-dimension-vista-protein-3-calibrator-3-fda-510k.jpg K072435 - DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L, 1 CONTROL M, 1 CONTROL H K072435 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Oct 2007. https://www.510kdatabase.net/k072797/ 2007-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k072797-ge-logiq-i-comapact-ultrasound-ge-fda-510k.jpg K072797 - GE LOGIQ I COMAPACT ULTRASOUND, GE LOGIQ E COMPACT ULTRASOUND, GE VIVID E COMPACT ULTRASOUND K072797 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Oct 2007. https://www.510kdatabase.net/k071087/ 2007-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k071087-vis-u-all-ii-heat-seal-pouch-and-tubing-fda-510k.jpg K071087 - VIS-U-ALL II HEAT-SEAL POUCH AND TUBING K071087 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Oct 2007. https://www.510kdatabase.net/k072221/ 2007-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k072221-modification-to-triathlon-ts-knee-system-fda-510k.jpg K072221 - MODIFICATION TO TRIATHLON TS KNEE SYSTEM K072221 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Oct 2007. https://www.510kdatabase.net/k072597/ 2007-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k072597-pro-dense-core-decompression-procedure-fda-510k.jpg K072597 - PRO-DENSE CORE DECOMPRESSION PROCEDURE KIT K072597 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Oct 2007. https://www.510kdatabase.net/k072668/ 2007-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k072668-vitek-2-gram-positive-vancomycin-fda-510k.jpg K072668 - VITEK 2 GRAM POSITIVE VANCOMYCIN K072668 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Oct 2007. https://www.510kdatabase.net/k072675/ 2007-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k072675-smith-nephew-arthroscope-fda-510k.jpg K072675 - SMITH & NEPHEW ARTHROSCOPE K072675 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 2007. https://www.510kdatabase.net/k070765/ 2007-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k070765-vis-u-all-ii-self-seal-pouch-fda-510k.jpg K070765 - VIS-U-ALL II SELF SEAL POUCH K070765 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Oct 2007. https://www.510kdatabase.net/k072716/ 2007-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k072716-vector-vision-hip-fda-510k.jpg K072716 - VECTOR VISION HIP K072716 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Oct 2007. https://www.510kdatabase.net/k071146/ 2007-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k071146-vidas-brahms-pct-assay-fda-510k.jpg K071146 - VIDAS B.R.A.H.M.S. PCT ASSAY K071146 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Oct 2007. https://www.510kdatabase.net/k072573/ 2007-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k072573-vectorvision-hip-and-hip-sr-fda-510k.jpg K072573 - VECTORVISION HIP AND HIP SR K072573 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Oct 2007. https://www.510kdatabase.net/k072237/ 2007-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k072237-magnetom-verio-fda-510k.jpg K072237 - MAGNETOM VERIO K072237 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 2007. https://www.510kdatabase.net/k071405/ 2007-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k071405-probe-holder-system-fda-510k.jpg K071405 - PROBE HOLDER SYSTEM K071405 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Oct 2007. https://www.510kdatabase.net/k071881/ 2007-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k071881-triathlon-pkr-system-fda-510k.jpg K071881 - TRIATHLON PKR SYSTEM K071881 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Oct 2007. https://www.510kdatabase.net/k070592/ 2007-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k070592-small-bone-wedge-fda-510k.jpg K070592 - SMALL BONE WEDGE K070592 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Oct 2007. https://www.510kdatabase.net/k070769/ 2007-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k070769-vhp-136-tray-fda-510k.jpg K070769 - VHP 136 TRAY K070769 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Oct 2007. https://www.510kdatabase.net/k070788/ 2007-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k070788-elecsys-cortisol-test-system-fda-510k.jpg K070788 - ELECSYS CORTISOL TEST SYSTEM K070788 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Oct 2007. https://www.510kdatabase.net/k071160/ 2007-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k071160-reflection-tandem-unipolar-fda-510k.jpg K071160 - REFLECTION, TANDEM UNIPOLAR K071160 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 2007. https://www.510kdatabase.net/k072072/ 2007-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k072072-harmony-led-1-surgical-lighting-system-fda-510k.jpg K072072 - HARMONY LED-1 SURGICAL LIGHTING SYSTEM K072072 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: STERIS Corporation. Cleared Oct 2007. https://www.510kdatabase.net/k072155/ 2007-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k072155-pioneer-catheter-fda-510k.jpg K072155 - PIONEER CATHETER K072155 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medtronic, Inc.. Cleared Oct 2007. https://www.510kdatabase.net/k072230/ 2007-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k072230-powerpicc-solo-fda-510k.jpg K072230 - POWERPICC SOLO K072230 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 2007. https://www.510kdatabase.net/k072737/ 2007-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k072737-cscs-001a-calcium-scoring-package-fda-510k.jpg K072737 - CSCS-001A CALCIUM SCORING PACKAGE K072737 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Oct 2007. https://www.510kdatabase.net/k062297/ 2007-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k062297-vhp-136-low-temperature-sterilization-fda-510k.jpg K062297 - VHP 136 LOW TEMPERATURE STERILIZATION SYSTEM K062297 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Oct 2007. https://www.510kdatabase.net/k071681/ 2007-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k071681-cytomics-fc-500-mpl-flow-cytometer-fda-510k.jpg K071681 - CYTOMICS FC 500 MPL FLOW CYTOMETER, MODEL # 626554 K071681 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Oct 2007. https://www.510kdatabase.net/k072465/ 2007-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k072465-niko-corpectomy-spacer-fda-510k.jpg K072465 - NIKO CORPECTOMY SPACER K072465 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Oct 2007. https://www.510kdatabase.net/k072148/ 2007-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k072148-ciaglia-blue-dolphin-tm-balloon-fda-510k.jpg K072148 - CIAGLIA BLUE DOLPHIN (TM) BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER K072148 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Cook, Inc.. Cleared Oct 2007. https://www.510kdatabase.net/k072606/ 2007-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k072606-aquilion-one-tsx-301a2-computed-fda-510k.jpg K072606 - AQUILION ONE TSX-301A/2 COMPUTED TOMOGRAPHY SYSTEM K072606 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Oct 2007. https://www.510kdatabase.net/k071830/ 2007-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k071830-depuy-delta-ts-ceramic-femoral-heads-fda-510k.jpg K071830 - DEPUY DELTA TS CERAMIC FEMORAL HEADS K071830 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Sep 2007. https://www.510kdatabase.net/k071920/ 2007-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k071920-autosuture-absorbable-tack-and-fda-510k.jpg K071920 - AUTOSUTURE ABSORBABLE TACK AND APPLICATOR K071920 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Sep 2007. https://www.510kdatabase.net/k072429/ 2007-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k072429-modification-to-tsrh-spinal-system-fda-510k.jpg K072429 - MODIFICATION TO TSRH SPINAL SYSTEM K072429 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Sep 2007. https://www.510kdatabase.net/k072095/ 2007-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k072095-synthes-usa-pediatric-lcp-hip-plate-fda-510k.jpg K072095 - SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONS K072095 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Sep 2007. https://www.510kdatabase.net/k072517/ 2007-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k072517-ilab-ultrasound-imaging-system-version-fda-510k.jpg K072517 - ILAB ULTRASOUND IMAGING SYSTEM, VERSION 1.3 K072517 is a FDA 510(k) cleared radiology medical device. Manufacturer: Boston Scientific Corp. Cleared Sep 2007. https://www.510kdatabase.net/k070556/ 2007-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k070556-brainsuite-net-fda-510k.jpg K070556 - BRAINSUITE NET K070556 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Sep 2007. https://www.510kdatabase.net/k071805/ 2007-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k071805-netguard-automated-clinician-alert-fda-510k.jpg K071805 - NETGUARD AUTOMATED CLINICIAN ALERT SYSTEM, MODEL 0998-00-1600-XX K071805 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Sep 2007. https://www.510kdatabase.net/k072392/ 2007-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k072392-opdima-digital-mammographic-x-ray-system-fda-510k.jpg K072392 - OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM K072392 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 2007. https://www.510kdatabase.net/k070809/ 2007-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k070809-bd-phoenix-automated-microbiology-fda-510k.jpg K070809 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MINOCYCLINE (GP) 1-32 UG/ML K070809 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Sep 2007. https://www.510kdatabase.net/k071982/ 2007-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k071982-modification-to-unity-network-id-fda-510k.jpg K071982 - MODIFICATION TO: UNITY NETWORK ID K071982 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Sep 2007. https://www.510kdatabase.net/k071071/ 2007-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k071071-crosslinked-polyethylene-articular-fda-510k.jpg K071071 - CROSSLINKED POLYETHYLENE ARTICULAR INSERTS K071071 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Sep 2007. https://www.510kdatabase.net/k072304/ 2007-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k072304-fibrinogen-calibrator-kit-fda-510k.jpg K072304 - FIBRINOGEN CALIBRATOR KIT K072304 is a FDA 510(k) cleared hematology medical device. Manufacturer: Dade Behring, Inc.. Cleared Sep 2007. https://www.510kdatabase.net/k072317/ 2007-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k072317-modification-totsrh-spinal-system-fda-510k.jpg K072317 - MODIFICATION TO:TSRH SPINAL SYSTEM K072317 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Sep 2007. https://www.510kdatabase.net/k072322/ 2007-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k072322-ultra-fast-fix-and-ultra-fast-fix-ab-fda-510k.jpg K072322 - ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS K072322 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Sep 2007. https://www.510kdatabase.net/k070927/ 2007-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k070927-hemosil-d-dimer-hs-fda-510k.jpg K070927 - HEMOSIL D-DIMER HS K070927 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 2007. https://www.510kdatabase.net/k070742/ 2007-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k070742-modification-to-vertex-reconstruction-fda-510k.jpg K070742 - MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM K070742 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Sep 2007. https://www.510kdatabase.net/k071239/ 2007-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k071239-total-protein-urinecsf-gen3-fda-510k.jpg K071239 - TOTAL PROTEIN URINE/CSF GEN.3 K071239 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Sep 2007. https://www.510kdatabase.net/k070361/ 2007-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k070361-mrsaselect-fda-510k.jpg K070361 - MRSASELECT K070361 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bio-Rad. Cleared Sep 2007. https://www.510kdatabase.net/k071082/ 2007-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k071082-stryker-modular-hip-system-fda-510k.jpg K071082 - STRYKER MODULAR HIP SYSTEM K071082 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Sep 2007. https://www.510kdatabase.net/k072387/ 2007-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k072387-karl-storz-video-rhino-laryngscope-fda-510k.jpg K072387 - KARL STORZ VIDEO RHINO-LARYNGSCOPE SYSTEM, MODEL 11101 SERIES K072387 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Sep 2007. https://www.510kdatabase.net/k071437/ 2007-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k071437-megafix-c-bioabsorbable-composite-fda-510k.jpg K071437 - MEGAFIX-C BIOABSORBABLE COMPOSITE INTERFERENCE SCREW, MODEL 2870719C, 2870723C, 2870823C, 2870828C, 2870928C K071437 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Sep 2007. https://www.510kdatabase.net/k071644/ 2007-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k071644-online-phenobarbital-model-03016757190-fda-510k.jpg K071644 - ONLINE PHENOBARBITAL, MODEL 03016757190 & 03510620 K071644 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Sep 2007. https://www.510kdatabase.net/k072038/ 2007-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k072038-vitek-2-gram-negative-levofloxacin-fda-510k.jpg K072038 - VITEK 2 GRAM NEGATIVE LEVOFLOXACIN K072038 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Sep 2007. https://www.510kdatabase.net/k070554/ 2007-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k070554-depuy-corail-amt-dysplasia-hip-fda-510k.jpg K070554 - DEPUY CORAIL AMT DYSPLASIA HIP PROSTHESIS K070554 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Sep 2007. https://www.510kdatabase.net/k071379/ 2007-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k071379-delta-xtend-reverse-shoulder-modular-fda-510k.jpg K071379 - DELTA XTEND REVERSE SHOULDER MODULAR STEM K071379 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Sep 2007. https://www.510kdatabase.net/k071980/ 2007-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k071980-dimension-vista-protein-1-calibrator-fda-510k.jpg K071980 - DIMENSION VISTA PROTEIN 1 CALIBRATOR, PROTEIN1 CONTROL L,M,H K071980 is a FDA 510(k) cleared immunology medical device. Manufacturer: Dade Behring, Inc.. Cleared Sep 2007. https://www.510kdatabase.net/k071471/ 2007-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k071471-corin-adaptor-sleeve-fda-510k.jpg K071471 - CORIN ADAPTOR SLEEVE K071471 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Sep 2007. https://www.510kdatabase.net/k072281/ 2007-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k072281-nexgen-prolong-all-poly-patella-fda-510k.jpg K072281 - NEXGEN PROLONG ALL-POLY PATELLA K072281 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Sep 2007. https://www.510kdatabase.net/k070895/ 2007-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k070895-verify-challenge-packs-models-270f-4-fda-510k.jpg K070895 - VERIFY CHALLENGE PACKS, MODELS 270F 4 CHALLENGE PACK K070895 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Sep 2007. https://www.510kdatabase.net/k072160/ 2007-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k072160-nexgen-trabecular-metal-tibial-tray-fda-510k.jpg K072160 - NEXGEN TRABECULAR METAL TIBIAL TRAY K072160 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Sep 2007. https://www.510kdatabase.net/k072164/ 2007-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k072164-dc-6-diagnostic-ultrasound-system-fda-510k.jpg K072164 - DC-6 DIAGNOSTIC ULTRASOUND SYSTEM K072164 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Sep 2007. https://www.510kdatabase.net/k071016/ 2007-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k071016-depuy-restore-orthobiologic-soft-fda-510k.jpg K071016 - DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT K071016 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Sep 2007. https://www.510kdatabase.net/k070579/ 2007-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k070579-storz-slx-f2-storm-touch-fda-510k.jpg K070579 - STORZ SLX-F2 STORM TOUCH K070579 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Aug 2007. https://www.510kdatabase.net/k072217/ 2007-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k072217-ecg-1250a-series-cardiofax-s-and-ecg-fda-510k.jpg K072217 - ECG-1250A SERIES CARDIOFAX S AND ECG-1350A SERIES CARDIOFAX M K072217 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Aug 2007. https://www.510kdatabase.net/k072075/ 2007-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k072075-modification-to-ge-logiq-a3-fda-510k.jpg K072075 - MODIFICATION TO GE LOGIQ A3 K072075 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Aug 2007. https://www.510kdatabase.net/k072266/ 2007-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k072266-acuson-p50-diagnostic-ultrasound-system-fda-510k.jpg K072266 - ACUSON P50 DIAGNOSTIC ULTRASOUND SYSTEM K072266 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 2007. https://www.510kdatabase.net/k071476/ 2007-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k071476-synthes-usa-2nd-generation-pelvic-c-fda-510k.jpg K071476 - SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP K071476 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Aug 2007. https://www.510kdatabase.net/k071530/ 2007-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k071530-karl-storz-video-flexible-video-ent-fda-510k.jpg K071530 - KARL STORZ VIDEO FLEXIBLE VIDEO ENT ENDOSCOPE SYSTEM K071530 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Aug 2007. https://www.510kdatabase.net/k071811/ 2007-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k071811-etoh-flex-reagent-cartridge-df22-fda-510k.jpg K071811 - ETOH FLEX REAGENT CARTRIDGE (DF22) K071811 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Dade Behring, Inc.. Cleared Aug 2007. https://www.510kdatabase.net/k062623/ 2007-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k062623-axiom-luminos-drf-fda-510k.jpg K062623 - AXIOM LUMINOS DRF K062623 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 2007. https://www.510kdatabase.net/k071032/ 2007-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k071032-arthrex-univers-ii-shoulder-prosthesis-fda-510k.jpg K071032 - ARTHREX UNIVERS II SHOULDER PROSTHESIS K071032 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Aug 2007. https://www.510kdatabase.net/k071316/ 2007-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k071316-microscan-synergies-plus-gram-positive-fda-510k.jpg K071316 - MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-STREPTOMYCIN SYNERGY SCREEN K071316 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Aug 2007. https://www.510kdatabase.net/k071317/ 2007-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k071317-microscan-synergies-plus-gram-positive-fda-510k.jpg K071317 - MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL-GENTAMICIN SYNERGY SCREEN K071317 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Aug 2007. https://www.510kdatabase.net/k071623/ 2007-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k071623-bd-phoenix-automated-microbiology-fda-510k.jpg K071623 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, AMPICILLIN-SULBACTAM (GN) 1/0.5-32/16 UG/ML K071623 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Aug 2007. https://www.510kdatabase.net/k070267/ 2007-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k070267-depuy-gck-tibial-components-fda-510k.jpg K070267 - DEPUY GCK TIBIAL COMPONENTS K070267 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Aug 2007. https://www.510kdatabase.net/k071790/ 2007-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k071790-genesis-ii-total-knee-system-legion-fda-510k.jpg K071790 - GENESIS II TOTAL KNEE SYSTEM, LEGION REVISION KNEE SYSTEM, JOURNEY BCS KNEE SYSTEM K071790 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Aug 2007. https://www.510kdatabase.net/k071834/ 2007-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k071834-stratus-cs-acute-care-nt-probnp-fda-510k.jpg K071834 - STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, MODEL CPBNPM K071834 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Aug 2007. https://www.510kdatabase.net/k071985/ 2007-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k071985-ge-vivid-s5-and-s6-diagnostic-ultrasound-fda-510k.jpg K071985 - GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND K071985 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Aug 2007. https://www.510kdatabase.net/k072060/ 2007-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k072060-qp-156e-ecg-exercise-test-option-for-fda-510k.jpg K072060 - QP-156E ECG EXERCISE TEST OPTION FOR THE ECG-1500A SERIES/CARDIOFAX V K072060 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Aug 2007. https://www.510kdatabase.net/k071459/ 2007-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k071459-b-braun-piston-syringes-and-omnican-fda-510k.jpg K071459 - B. BRAUN PISTON SYRINGES AND OMNICAN AND OMNIFIX INSULIN SYRINGES K071459 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Aug 2007. https://www.510kdatabase.net/k070005/ 2007-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k070005-hemosil-recombiplastin-2g-fda-510k.jpg K070005 - HEMOSIL RECOMBIPLASTIN 2G K070005 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Aug 2007. https://www.510kdatabase.net/k071738/ 2007-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k071738-exactech-optetrak-proximal-tibial-spacer-fda-510k.jpg K071738 - EXACTECH OPTETRAK PROXIMAL TIBIAL SPACER K071738 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Aug 2007. https://www.510kdatabase.net/k071978/ 2007-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k071978-mini-tightrope-ft-repair-kit-fda-510k.jpg K071978 - MINI TIGHTROPE FT REPAIR KIT K071978 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Aug 2007. https://www.510kdatabase.net/k071991/ 2007-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k071991-modification-to-scorpio-nrg-knee-system-fda-510k.jpg K071991 - MODIFICATION TO SCORPIO NRG KNEE SYSTEM K071991 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Aug 2007. https://www.510kdatabase.net/k071033/ 2007-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k071033-t2-xvbr-spinal-system-fda-510k.jpg K071033 - T2 XVBR SPINAL SYSTEM K071033 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Aug 2007. https://www.510kdatabase.net/k071925/ 2007-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k071925-magnetom-essenza-fda-510k.jpg K071925 - MAGNETOM ESSENZA K071925 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 2007. https://www.510kdatabase.net/k071873/ 2007-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k071873-modification-to-eclipse-treatment-fda-510k.jpg K071873 - MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM K071873 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Aug 2007. https://www.510kdatabase.net/k071247/ 2007-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k071247-n-latex-rf-kit-fda-510k.jpg K071247 - N LATEX RF KIT K071247 is a FDA 510(k) cleared immunology medical device. Manufacturer: Dade Behring, Inc.. Cleared Aug 2007. https://www.510kdatabase.net/k071563/ 2007-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k071563-peri-loc-periarticular-locked-plating-fda-510k.jpg K071563 - PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM K071563 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Aug 2007. https://www.510kdatabase.net/k071767/ 2007-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k071767-dimensions-pbnp-flex-reagent-cartridge-fda-510k.jpg K071767 - DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A K071767 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Aug 2007. https://www.510kdatabase.net/k063835/ 2007-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k063835-allevyn-ag-dressing-fda-510k.jpg K063835 - ALLEVYN AG DRESSING K063835 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Aug 2007. https://www.510kdatabase.net/k071176/ 2007-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k071176-modification-to-arthrex-interference-fda-510k.jpg K071176 - MODIFICATION TO: ARTHREX INTERFERENCE SCREW K071176 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Aug 2007. https://www.510kdatabase.net/k071417/ 2007-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k071417-depuy-lps-diaphyseal-and-metaphyseal-fda-510k.jpg K071417 - DEPUY LPS DIAPHYSEAL AND METAPHYSEAL SLEEVES K071417 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Aug 2007. https://www.510kdatabase.net/k070201/ 2007-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k070201-bard-intra-abdominal-pressure-fda-510k.jpg K070201 - BARD INTRA-ABDOMINAL PRESSURE MONITORING DEVICE, MODEL IAP-001 K070201 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Aug 2007. https://www.510kdatabase.net/k071211/ 2007-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k071211-cobas-c-111-analyzer-fda-510k.jpg K071211 - COBAS C 111 ANALYZER K071211 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Jul 2007. https://www.510kdatabase.net/k071791/ 2007-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k071791-modification-to-cranioplastic-model-43-fda-510k.jpg K071791 - MODIFICATION TO CRANIOPLASTIC, MODEL 43-1280 K071791 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Jul 2007. https://www.510kdatabase.net/k071856/ 2007-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k071856-zimmer-ml-taper-hip-prosthesis-with-fda-510k.jpg K071856 - ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM, MODEL(S) 7848 SERIES( MODULAR NECKS), 7713 SERIES K071856 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jul 2007. https://www.510kdatabase.net/k072000/ 2007-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k072000-aplio-xg-diagnostic-ultrasound-system-fda-510k.jpg K072000 - APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A VERSION 2.0 K072000 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Jul 2007. https://www.510kdatabase.net/k071950/ 2007-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k071950-syngo-trued-fda-510k.jpg K071950 - SYNGO TRUED K071950 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 2007. https://www.510kdatabase.net/k071776/ 2007-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k071776-aneuroplastic-model-43-1290-fda-510k.jpg K071776 - ANEUROPLASTIC, MODEL 43-1290 K071776 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Jul 2007. https://www.510kdatabase.net/k071784/ 2007-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k071784-depuy-pinnacle-with-gripton-acetabular-fda-510k.jpg K071784 - DEPUY PINNACLE WITH GRIPTON ACETABULAR CUPS K071784 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jul 2007. https://www.510kdatabase.net/k071300/ 2007-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k071300-modification-to-smith-nephew-rf-fda-510k.jpg K071300 - MODIFICATION TO SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE K071300 is a FDA 510(k) cleared neurology medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 2007. https://www.510kdatabase.net/k071292/ 2007-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k071292-view-md-office-system-model-410665540-fda-510k.jpg K071292 - VIEW MD OFFICE SYSTEM, MODEL 41066.5540 K071292 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Jul 2007. https://www.510kdatabase.net/k071676/ 2007-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k071676-exactech-novation-crown-cup-fda-510k.jpg K071676 - EXACTECH NOVATION CROWN CUP CONSTRAINED LINERS AND RINGS K071676 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Jul 2007. https://www.510kdatabase.net/k070346/ 2007-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k070346-dade-behring-labpro-alert-software-fda-510k.jpg K070346 - DADE BEHRING LABPRO ALERT SOFTWARE SYSTEM K070346 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Jul 2007. https://www.510kdatabase.net/k071423/ 2007-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k071423-medline-latex-foley-catheter-fda-510k.jpg K071423 - MEDLINE LATEX FOLEY CATHETER K071423 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medline Industries, Inc.. Cleared Jul 2007. https://www.510kdatabase.net/k070461/ 2007-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k070461-verify-steam-indicators-models-250f-25-fda-510k.jpg K070461 - VERIFY STEAM INDICATORS, MODELS 250F 25, 250F 30, 270F 15, 270F 3-10 AND 270F 4 K070461 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Jul 2007. https://www.510kdatabase.net/k071175/ 2007-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k071175-ohmeda-medical-giraffe-omnibed-fda-510k.jpg K071175 - OHMEDA MEDICAL GIRAFFE OMNIBED K071175 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ge Healthcare. Cleared Jul 2007. https://www.510kdatabase.net/k071467/ 2007-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k071467-varisource-ix-hdr-afterloader-fda-510k.jpg K071467 - VARISOURCE IX HDR AFTERLOADER K071467 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Jul 2007. https://www.510kdatabase.net/k070709/ 2007-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k070709-roche-elecsys-pth-test-system-fda-510k.jpg K070709 - ROCHE ELECSYS PTH TEST SYSTEM K070709 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jul 2007. https://www.510kdatabase.net/k071309/ 2007-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k071309-blue-max-balloon-dilatation-catheter-fda-510k.jpg K071309 - BLUE MAX BALLOON DILATATION CATHETER K071309 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Jul 2007. https://www.510kdatabase.net/k071718/ 2007-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k071718-trilogy-longevity-constrained-liner-fda-510k.jpg K071718 - TRILOGY LONGEVITY CONSTRAINED LINER K071718 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jul 2007. https://www.510kdatabase.net/k071634/ 2007-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k071634-modification-tocontour-se-microspheres-fda-510k.jpg K071634 - MODIFICATION TO:CONTOUR SE MICROSPHERES K071634 is a FDA 510(k) cleared neurology medical device. Manufacturer: Boston Scientific Corp. Cleared Jul 2007. https://www.510kdatabase.net/k071640/ 2007-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k071640-ventriclear-ii-spectrum-ventricular-fda-510k.jpg K071640 - VENTRICLEAR II, SPECTRUM VENTRICULAR DRAINAGE CATHETER, MODEL N-VVDC-02-ABRM K071640 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cook, Inc.. Cleared Jul 2007. https://www.510kdatabase.net/k070785/ 2007-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k070785-dynasty-acetabular-system-fda-510k.jpg K070785 - DYNASTY ACETABULAR SYSTEM K070785 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jul 2007. https://www.510kdatabase.net/k071630/ 2007-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k071630-terumo-31g-thinpro-insulin-syringe-fda-510k.jpg K071630 - TERUMO 31G THINPRO INSULIN SYRINGE K071630 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terumo Medical Corp.. Cleared Jul 2007. https://www.510kdatabase.net/k071264/ 2007-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k071264-synthes-usa-2427-mm-locking-foot-module-fda-510k.jpg K071264 - SYNTHES (USA) 2.4/2.7 MM LOCKING FOOT MODULE K071264 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jul 2007. https://www.510kdatabase.net/k071107/ 2007-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k071107-gender-solutions-natural-knee-flex-fda-510k.jpg K071107 - GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM K071107 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jul 2007. https://www.510kdatabase.net/k070317/ 2007-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k070317-zeus-scientific-inc-vzv-igm-elisa-test-fda-510k.jpg K070317 - ZEUS SCIENTIFIC, INC VZV IGM ELISA TEST SYSTEM K070317 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Jul 2007. https://www.510kdatabase.net/k070978/ 2007-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k070978-zimmer-segmental-system-fda-510k.jpg K070978 - ZIMMER SEGMENTAL SYSTEM K070978 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jul 2007. https://www.510kdatabase.net/k071253/ 2007-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k071253-affinity-pediatric-arterial-filter-fda-510k.jpg K071253 - AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB4014 K071253 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jul 2007. https://www.510kdatabase.net/k071622/ 2007-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k071622-arthrex-fiberwire-fda-510k.jpg K071622 - ARTHREX FIBERWIRE K071622 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Arthrex, Inc.. Cleared Jul 2007. https://www.510kdatabase.net/k071334/ 2007-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k071334-depuy-cas-hemi-asr-hip-instruments-fda-510k.jpg K071334 - DEPUY CAS HEMI ASR HIP INSTRUMENTS K071334 is a FDA 510(k) cleared neurology medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jul 2007. https://www.510kdatabase.net/k071569/ 2007-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k071569-allthread-peek-anchor-with-tantalum-fda-510k.jpg K071569 - ALLTHREAD PEEK ANCHOR WITH TANTALUM MARKER K071569 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jul 2007. https://www.510kdatabase.net/k070770/ 2007-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k070770-gore-balloon-sheath-fda-510k.jpg K070770 - GORE BALLOON SHEATH K070770 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Jun 2007. https://www.510kdatabase.net/k071053/ 2007-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k071053-recap-ha-press-fit-femoral-resurfacing-fda-510k.jpg K071053 - RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD K071053 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jun 2007. https://www.510kdatabase.net/k071058/ 2007-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k071058-multiple-patient-receiver-model-org-fda-510k.jpg K071058 - MULTIPLE PATIENT RECEIVER, MODEL ORG-9700A K071058 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Jun 2007. https://www.510kdatabase.net/k071066/ 2007-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k071066-spycatch-stone-retrieval-basket-fda-510k.jpg K071066 - SPYCATCH STONE RETRIEVAL BASKET K071066 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Jun 2007. https://www.510kdatabase.net/k071177/ 2007-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k071177-arthrex-bio-composite-suture-anchors-fda-510k.jpg K071177 - ARTHREX BIO- COMPOSITE SUTURE ANCHORS: BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK, BIO-COMPOSITE CORKSCREW K071177 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jun 2007. https://www.510kdatabase.net/k071234/ 2007-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k071234-acunav-diagnostic-ultrasound-catheter-fda-510k.jpg K071234 - ACUNAV DIAGNOSTIC ULTRASOUND CATHETER 8F AND 10F K071234 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 2007. https://www.510kdatabase.net/k063670/ 2007-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k063670-modifications-to-cd-horizon-spinal-fda-510k.jpg K063670 - MODIFICATIONS TO CD HORIZON SPINAL SYSTEM K063670 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Jun 2007. https://www.510kdatabase.net/k070791/ 2007-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k070791-pm-series-patient-monitors-models-pm-fda-510k.jpg K070791 - PM SERIES PATIENT MONITORS, MODELS PM-9000 EXPRESS AND PM-8000 EXPRESS K070791 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Jun 2007. https://www.510kdatabase.net/k070849/ 2007-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k070849-depuy-gck-femoral-and-tibial-components-fda-510k.jpg K070849 - DEPUY GCK FEMORAL AND TIBIAL COMPONENTS K070849 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jun 2007. https://www.510kdatabase.net/k071268/ 2007-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k071268-microscan-synergies-plus-gram-positive-fda-510k.jpg K071268 - MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS WITH TETRACYCLINE K071268 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Jun 2007. https://www.510kdatabase.net/k071184/ 2007-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k071184-synthes-usa-variable-angle-locking-fda-510k.jpg K071184 - SYNTHES (USA) VARIABLE ANGLE-LOCKING COMPRESSION PLATE (VA-LCP) DISTAL RADIUS SYSTEM K071184 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jun 2007. https://www.510kdatabase.net/k070159/ 2007-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k070159-prelude-sheath-introducer-fda-510k.jpg K070159 - PRELUDE SHEATH INTRODUCER K070159 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jun 2007. https://www.510kdatabase.net/k071002/ 2007-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k071002-immage-immunochemistry-systems-high-fda-510k.jpg K071002 - IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENT K071002 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jun 2007. https://www.510kdatabase.net/k063282/ 2007-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k063282-contiplex-stim-continuous-nerve-block-fda-510k.jpg K063282 - CONTIPLEX STIM CONTINUOUS NERVE BLOCK SET K063282 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Jun 2007. https://www.510kdatabase.net/k063818/ 2007-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k063818-quanta-plex-celiac-iga-profile-fda-510k.jpg K063818 - QUANTA PLEX CELIAC IGA PROFILE K063818 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Jun 2007. https://www.510kdatabase.net/k070288/ 2007-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k070288-cardioblate-monopolar-pen-60813-fda-510k.jpg K070288 - CARDIOBLATE MONOPOLAR PEN, 60813, CARDIOBLATE MONOPOLAR XL, 60814 K070288 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jun 2007. https://www.510kdatabase.net/k071020/ 2007-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k071020-datex-ohmeda-s5-compact-critical-care-fda-510k.jpg K071020 - DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU05 AND L-CICU05A SOFTWARE K071020 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Healthcare. Cleared Jun 2007. https://www.510kdatabase.net/k070853/ 2007-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k070853-dimension-vista-etoh-flex-reagent-fda-510k.jpg K070853 - DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022 K070853 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Jun 2007. https://www.510kdatabase.net/k071042/ 2007-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k071042-polarcath-peripheral-dilatation-system-fda-510k.jpg K071042 - POLARCATH PERIPHERAL DILATATION SYSTEM K071042 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Jun 2007. https://www.510kdatabase.net/k071179/ 2007-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k071179-noras-or-head-holder-fda-510k.jpg K071179 - NORAS OR HEAD HOLDER K071179 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 2007. https://www.510kdatabase.net/k063407/ 2007-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k063407-bc-3200-auto-hematology-analyzer-fda-510k.jpg K063407 - BC-3200 AUTO HEMATOLOGY ANALYZER K063407 is a FDA 510(k) cleared hematology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Jun 2007. https://www.510kdatabase.net/k071360/ 2007-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k071360-optical-guidance-platform-fda-510k.jpg K071360 - OPTICAL GUIDANCE PLATFORM K071360 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Jun 2007. https://www.510kdatabase.net/k063685/ 2007-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k063685-optecure-fda-510k.jpg K063685 - OPTECURE K063685 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Jun 2007. https://www.510kdatabase.net/k070695/ 2007-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k070695-zimmer-patellofemoral-joint-prosthesis-fda-510k.jpg K070695 - ZIMMER PATELLOFEMORAL JOINT PROSTHESIS K070695 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jun 2007. https://www.510kdatabase.net/k070756/ 2007-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k070756-smith-and-nephew-reflection-3-fda-510k.jpg K070756 - SMITH AND NEPHEW REFLECTION 3 ACETABULAR SYSTEM K070756 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jun 2007. https://www.510kdatabase.net/k070946/ 2007-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k070946-synthes-lcp-diaphyseal-metaphyseal-dia-fda-510k.jpg K070946 - SYNTHES LCP DIAPHYSEAL-METAPHYSEAL (DIA-META) VOLAR DISTAL RADIUS PLATES K070946 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jun 2007. https://www.510kdatabase.net/k071249/ 2007-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k071249-ultrapro-hernia-system-models-uhsl-fda-510k.jpg K071249 - ULTRAPRO* HERNIA SYSTEM, MODELS UHSL, UHSM, UHSOV K071249 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Jun 2007. https://www.510kdatabase.net/k070095/ 2007-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k070095-triathlon-ts-knee-system-fda-510k.jpg K070095 - TRIATHLON TS KNEE SYSTEM K070095 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jun 2007. https://www.510kdatabase.net/k071277/ 2007-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k071277-synchron-lx20-clinical-systems-fda-510k.jpg K071277 - SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMS K071277 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jun 2007. https://www.510kdatabase.net/k071280/ 2007-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k071280-synchron-cx-delta-clinical-systems-fda-510k.jpg K071280 - SYNCHRON CX DELTA CLINICAL SYSTEMS, CREATININE TEST SYSTEMS K071280 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jun 2007. https://www.510kdatabase.net/k071283/ 2007-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k071283-synchron-systems-creatinine-reagent-fda-510k.jpg K071283 - SYNCHRON SYSTEMS CREATININE REAGENT K071283 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jun 2007. https://www.510kdatabase.net/k070716/ 2007-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k070716-image-1-video-imaging-system-with-fda-510k.jpg K070716 - IMAGE 1 VIDEO IMAGING SYSTEM WITH OPTIONAL INSUFFLATORS CONTROL K070716 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared May 2007. https://www.510kdatabase.net/k070585/ 2007-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k070585-accu-chek-performa-system-fda-510k.jpg K070585 - ACCU-CHEK PERFORMA SYSTEM K070585 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared May 2007. https://www.510kdatabase.net/k071222/ 2007-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k071222-infusor-sv-and-lv-elastomeric-infusion-fda-510k.jpg K071222 - INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES K071222 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared May 2007. https://www.510kdatabase.net/k071135/ 2007-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k071135-depuy-ci-hip-instrumentation-fda-510k.jpg K071135 - DEPUY CI HIP INSTRUMENTATION K071135 is a FDA 510(k) cleared neurology medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared May 2007. https://www.510kdatabase.net/k070827/ 2007-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k070827-karl-storz-scb-interface-control-model-fda-510k.jpg K070827 - KARL STORZ SCB INTERFACE CONTROL, MODEL 20090120 K070827 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared May 2007. https://www.510kdatabase.net/k071314/ 2007-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k071314-sonoline-g20-diagnostic-ultrasound-fda-510k.jpg K071314 - SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMS K071314 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 2007. https://www.510kdatabase.net/k071076/ 2007-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k071076-synergies-plus-gram-positive-miccombo-fda-510k.jpg K071076 - SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS K071076 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared May 2007. https://www.510kdatabase.net/k070565/ 2007-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k070565-cofield-total-shoulder-system-fda-510k.jpg K070565 - COFIELD TOTAL SHOULDER SYSTEM K070565 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared May 2007. https://www.510kdatabase.net/k071117/ 2007-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k071117-modification-to-pinnacle-constrained-fda-510k.jpg K071117 - MODIFICATION TO PINNACLE CONSTRAINED ACETABULAR LINERS K071117 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared May 2007. https://www.510kdatabase.net/k071204/ 2007-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k071204-site-rite-6-ultrasound-system-model-fda-510k.jpg K071204 - SITE-RITE 6 ULTRASOUND SYSTEM, MODEL SITE-RITE 6 K071204 is a FDA 510(k) cleared radiology medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 2007. https://www.510kdatabase.net/k070885/ 2007-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k070885-universal-taper-delta-femoral-head-fda-510k.jpg K070885 - UNIVERSAL TAPER DELTA FEMORAL HEAD K070885 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared May 2007. https://www.510kdatabase.net/k071068/ 2007-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k071068-biograph-6-truepoint-model-biograph-6-fda-510k.jpg K071068 - BIOGRAPH 6 TRUEPOINT, MODEL BIOGRAPH 6 - P/N 10238197 K071068 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 2007. https://www.510kdatabase.net/k070860/ 2007-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k070860-microscan-synergies-plus-gram-positive-fda-510k.jpg K070860 - MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH CLINDAMYCIN K070860 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared May 2007. https://www.510kdatabase.net/k070883/ 2007-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k070883-duracon-x3-cs-tibial-insert-fda-510k.jpg K070883 - DURACON X3 CS TIBIAL INSERT K070883 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared May 2007. https://www.510kdatabase.net/k071041/ 2007-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k071041-coaguchek-xs-plus-system-fda-510k.jpg K071041 - COAGUCHEK XS PLUS SYSTEM K071041 is a FDA 510(k) cleared hematology medical device. Manufacturer: Roche Diagnostics. Cleared May 2007. https://www.510kdatabase.net/k071073/ 2007-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k071073-solar-8000-and-transport-pro-with-fda-510k.jpg K071073 - SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE K071073 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared May 2007. https://www.510kdatabase.net/k071092/ 2007-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k071092-asnis-micro-cannulated-screw-fda-510k.jpg K071092 - ASNIS MICRO CANNULATED SCREW K071092 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared May 2007. https://www.510kdatabase.net/k071015/ 2007-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k071015-opdima-digital-mammographic-x-ray-system-fda-510k.jpg K071015 - OPDIMA DIGITAL MAMMOGRAPHIC X-RAY SYSTEM K071015 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 2007. https://www.510kdatabase.net/k062395/ 2007-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k062395-accu-chek-smart-pix-fda-510k.jpg K062395 - ACCU-CHEK SMART PIX K062395 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared May 2007. https://www.510kdatabase.net/k070437/ 2007-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k070437-pro-dense-bone-void-filler-fda-510k.jpg K070437 - PRO-DENSE BONE VOID FILLER K070437 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared May 2007. https://www.510kdatabase.net/k070996/ 2007-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k070996-4-fr-single-lumen-sl-powerpicc-catheter-fda-510k.jpg K070996 - 4 FR SINGLE LUMEN (SL) POWERPICC CATHETER K070996 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 2007. https://www.510kdatabase.net/den060009/ 2007-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/den060009-3m-n95-home-respirator-with-fluid-fda-510k.jpg DEN060009 - 3M N95 HOME RESPIRATOR WITH FLUID RESISTANCE DEN060009 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared May 2007. https://www.510kdatabase.net/k070527/ 2007-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k070527-arcuate-vertebral-augmentation-system-fda-510k.jpg K070527 - ARCUATE VERTEBRAL AUGMENTATION SYSTEM K070527 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared May 2007. https://www.510kdatabase.net/k070626/ 2007-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k070626-synchron-systems-high-sensitivity-fda-510k.jpg K070626 - SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH) REAGENT K070626 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared May 2007. https://www.510kdatabase.net/k070963/ 2007-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k070963-reunion-ha-fracture-stem-fda-510k.jpg K070963 - REUNION HA FRACTURE STEM K070963 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared May 2007. https://www.510kdatabase.net/k070364/ 2007-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k070364-100kgy-e-poly-maxrom-acetabular-liners-fda-510k.jpg K070364 - 100KGY E-POLY MAXROM ACETABULAR LINERS K070364 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared May 2007. https://www.510kdatabase.net/k070843/ 2007-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k070843-synthes-adolescent-lateral-entry-fda-510k.jpg K070843 - SYNTHES ADOLESCENT LATERAL ENTRY FEMORAL NAIL SYSTEM K070843 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared May 2007. https://www.510kdatabase.net/k070752/ 2007-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k070752-ksea-miniature-endoscope-model-11565-fda-510k.jpg K070752 - KSEA MINIATURE ENDOSCOPE, MODEL 11565 K070752 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared May 2007. https://www.510kdatabase.net/k070906/ 2007-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k070906-modificaton-to-zimmer-periarticular-fda-510k.jpg K070906 - MODIFICATON TO: ZIMMER PERIARTICULAR LOCKING PLATES AND SCREWS K070906 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared May 2007. https://www.510kdatabase.net/k070552/ 2007-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k070552-dimension-vista-ferritin-flex-reagent-fda-510k.jpg K070552 - DIMENSION VISTA FERRITIN FLEX REAGENT CARTRIDGE (FERR) K070552 is a FDA 510(k) cleared immunology medical device. Manufacturer: Dade Behring, Inc.. Cleared Apr 2007. https://www.510kdatabase.net/k063695/ 2007-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k063695-runthrough-ns-fda-510k.jpg K063695 - RUNTHROUGH NS K063695 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Apr 2007. https://www.510kdatabase.net/k070410/ 2007-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k070410-cook-microwire-wire-guide-fda-510k.jpg K070410 - COOK MICROWIRE WIRE GUIDE K070410 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Apr 2007. https://www.510kdatabase.net/k063582/ 2007-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k063582-zimmer-cut-resistant-glove-liner-fda-510k.jpg K063582 - ZIMMER CUT RESISTANT GLOVE LINER, XSMALL, SMALL, MEDIUM, LARGE, XLARGE K063582 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zimmer, Inc.. Cleared Apr 2007. https://www.510kdatabase.net/k070886/ 2007-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k070886-merogel-injectable-bioresorbable-stent-fda-510k.jpg K070886 - MEROGEL INJECTABLE BIORESORBABLE STENT K070886 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Medtronic, Inc.. Cleared Apr 2007. https://www.510kdatabase.net/k070311/ 2007-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k070311-cardioblate-gemini-surgical-ablation-fda-510k.jpg K070311 - CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE, MODELS 49260 AND 49261 K070311 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medtronic Vascular. Cleared Apr 2007. https://www.510kdatabase.net/k070879/ 2007-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k070879-bard-malecot-and-pezzer-drains-fda-510k.jpg K070879 - BARD MALECOT AND PEZZER DRAINS K070879 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 2007. https://www.510kdatabase.net/k070106/ 2007-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k070106-vv-fluoro-3d-fda-510k.jpg K070106 - VV FLUORO 3D K070106 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Apr 2007. https://www.510kdatabase.net/k070775/ 2007-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k070775-modification-to-providence-anterior-fda-510k.jpg K070775 - MODIFICATION TO: PROVIDENCE ANTERIOR CERVICAL PLATE SYSTEM K070775 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Apr 2007. https://www.510kdatabase.net/k070224/ 2007-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k070224-ultrapro-plug-fda-510k.jpg K070224 - ULTRAPRO PLUG K070224 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Apr 2007. https://www.510kdatabase.net/k063329/ 2007-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k063329-abbott-architect-havab-m-fda-510k.jpg K063329 - ABBOTT ARCHITECT HAVAB-M K063329 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Apr 2007. https://www.510kdatabase.net/k063790/ 2007-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k063790-the-synthes-matrixmandible-plate-and-fda-510k.jpg K063790 - THE SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM K063790 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Apr 2007. https://www.510kdatabase.net/k070125/ 2007-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k070125-colleague-guardian-configuration-tool-fda-510k.jpg K070125 - COLLEAGUE GUARDIAN CONFIGURATION TOOL K070125 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Apr 2007. https://www.510kdatabase.net/k070454/ 2007-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k070454-omega-3-supracondylar-plate-fda-510k.jpg K070454 - OMEGA 3 SUPRACONDYLAR PLATE K070454 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Apr 2007. https://www.510kdatabase.net/k062194/ 2007-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k062194-hypervisor-vi-central-monitoring-system-fda-510k.jpg K062194 - HYPERVISOR VI CENTRAL MONITORING SYSTEM K062194 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Apr 2007. https://www.510kdatabase.net/k070066/ 2007-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k070066-quanta-lite-rna-pol-iii-elisa-fda-510k.jpg K070066 - QUANTA LITE RNA POL III ELISA K070066 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Apr 2007. https://www.510kdatabase.net/k062862/ 2007-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k062862-olympus-uric-acid-reagent-model-osr6x98-fda-510k.jpg K062862 - OLYMPUS URIC ACID REAGENT, MODEL OSR6X98 K062862 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus America, Inc.. Cleared Apr 2007. https://www.510kdatabase.net/k063458/ 2007-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k063458-3m-tegaderm-chg-dressing-fda-510k.jpg K063458 - 3M TEGADERM CHG DRESSING K063458 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3M Company. Cleared Apr 2007. https://www.510kdatabase.net/k063565/ 2007-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k063565-quanta-lite-ss-a-52-elisa-fda-510k.jpg K063565 - QUANTA LITE SS-A 52 ELISA K063565 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Apr 2007. https://www.510kdatabase.net/k063848/ 2007-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k063848-powergroshong-picc-catheter-fda-510k.jpg K063848 - POWERGROSHONG PICC CATHETER K063848 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 2007. https://www.510kdatabase.net/k070644/ 2007-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k070644-gore-seamguard-staple-line-fda-510k.jpg K070644 - GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL FOR CIRCULAR STAPLERS K070644 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Apr 2007. https://www.510kdatabase.net/k070525/ 2007-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k070525-charlotte-70-multi-use-compression-fda-510k.jpg K070525 - CHARLOTTE 7.0 MULTI-USE COMPRESSION SCREW AND WASHER K070525 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Mar 2007. https://www.510kdatabase.net/k070635/ 2007-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k070635-hemosil-proclot-fda-510k.jpg K070635 - HEMOSIL PROCLOT K070635 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Mar 2007. https://www.510kdatabase.net/k070208/ 2007-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k070208-synthes-45-mm-lcp-posterolateral-fda-510k.jpg K070208 - SYNTHES 4.5 MM LCP POSTEROLATERAL PROXIMAL FEMUR PLATES K070208 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Mar 2007. https://www.510kdatabase.net/k070423/ 2007-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k070423-tr-band-fda-510k.jpg K070423 - TR BAND K070423 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Mar 2007. https://www.510kdatabase.net/k070576/ 2007-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k070576-acuson-x150-ultrasound-system-fda-510k.jpg K070576 - ACUSON X150 ULTRASOUND SYSTEM K070576 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2007. https://www.510kdatabase.net/k063324/ 2007-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k063324-pet-vcar-fda-510k.jpg K063324 - PET VCAR K063324 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Mar 2007. https://www.510kdatabase.net/k063356/ 2007-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k063356-stratus-cs-acute-care-d-dimer-testpak-fda-510k.jpg K063356 - STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK K063356 is a FDA 510(k) cleared hematology medical device. Manufacturer: Dade Behring, Inc.. Cleared Mar 2007. https://www.510kdatabase.net/k063804/ 2007-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k063804-olympus-triglyceride-test-system-fda-510k.jpg K063804 - OLYMPUS TRIGLYCERIDE TEST SYSTEM K063804 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus America, Inc.. Cleared Mar 2007. https://www.510kdatabase.net/k070526/ 2007-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k070526-dp-9900-digital-ultrasonic-diagnostic-fda-510k.jpg K070526 - DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM K070526 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Mar 2007. https://www.510kdatabase.net/k062720/ 2007-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k062720-s-line-bipolar-resectoscopes-and-fda-510k.jpg K062720 - S-LINE BIPOLAR RESECTOSCOPES AND BIPOLAR ELECTRODES K062720 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Mar 2007. https://www.510kdatabase.net/k063128/ 2007-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k063128-advance-spiked-porous-tibial-base-fda-510k.jpg K063128 - ADVANCE SPIKED POROUS TIBIAL BASE K063128 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Mar 2007. https://www.510kdatabase.net/k063186/ 2007-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k063186-athena-multi-lyte-rubella-igg-test-fda-510k.jpg K063186 - ATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEM K063186 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Mar 2007. https://www.510kdatabase.net/k063663/ 2007-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k063663-dimension-vista-stfr-flex-reagent-fda-510k.jpg K063663 - DIMENSION VISTA STFR FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H K063663 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Mar 2007. https://www.510kdatabase.net/k070073/ 2007-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k070073-align-urethral-support-system-fda-510k.jpg K070073 - ALIGN URETHRAL SUPPORT SYSTEM K070073 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 2007. https://www.510kdatabase.net/k070391/ 2007-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k070391-elecsys-pth-test-system-fda-510k.jpg K070391 - ELECSYS PTH TEST SYSTEM K070391 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Mar 2007. https://www.510kdatabase.net/k063756/ 2007-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k063756-dimension-vista-ctni-flex-reagent-fda-510k.jpg K063756 - DIMENSION VISTA CTNI FLEX REAGENT CARTRIDGE K063756 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Mar 2007. https://www.510kdatabase.net/k070200/ 2007-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k070200-tdm-control-set-model-cat-04521536-fda-510k.jpg K070200 - TDM CONTROL SET, MODEL CAT# 04521536 K070200 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Mar 2007. https://www.510kdatabase.net/k062976/ 2007-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k062976-modification-to-cic-pro-clinical-fda-510k.jpg K062976 - MODIFICATION TO CIC PRO CLINICAL INFORMATION CENTER K062976 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Mar 2007. https://www.510kdatabase.net/k070214/ 2007-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k070214-gender-solutions-natural-knee-flex-fda-510k.jpg K070214 - GENDER SOLUTIONS NATURAL-KNEE FLEX SYSTEM K070214 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Mar 2007. https://www.510kdatabase.net/k070440/ 2007-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k070440-bd-hypoint-needle-fda-510k.jpg K070440 - BD HYPOINT NEEDLE K070440 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson & CO. Cleared Mar 2007. https://www.510kdatabase.net/k063875/ 2007-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k063875-stryker-foot-plating-system-fda-510k.jpg K063875 - STRYKER FOOT PLATING SYSTEM K063875 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Mar 2007. https://www.510kdatabase.net/k070479/ 2007-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k070479-exactech-novation-crown-cup-and-liners-fda-510k.jpg K070479 - EXACTECH NOVATION CROWN CUP AND LINERS K070479 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Mar 2007. https://www.510kdatabase.net/k062203/ 2007-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k062203-tina-quant-d-dimer-test-system-fda-510k.jpg K062203 - TINA-QUANT D-DIMER TEST SYSTEM K062203 is a FDA 510(k) cleared hematology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Mar 2007. https://www.510kdatabase.net/k062327/ 2007-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k062327-modification-to-s4-spinal-system-fda-510k.jpg K062327 - MODIFICATION TO S4 SPINAL SYSTEM K062327 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aesculap, Inc.. Cleared Mar 2007. https://www.510kdatabase.net/k070538/ 2007-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k070538-xp-bond-dual-cure-universal-total-etch-fda-510k.jpg K070538 - XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE K070538 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Mar 2007. https://www.510kdatabase.net/k062872/ 2007-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k062872-synthes-usa-pediatric-lcp-hip-plate-fda-510k.jpg K062872 - SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM K062872 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Mar 2007. https://www.510kdatabase.net/k063248/ 2007-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k063248-arcuate-vertebral-augmentation-system-fda-510k.jpg K063248 - ARCUATE VERTEBRAL AUGMENTATION SYSTEM K063248 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Mar 2007. https://www.510kdatabase.net/k070421/ 2007-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k070421-datex-ohmeda-s5-device-interfacing-fda-510k.jpg K070421 - DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX..01 WITH N-DISVENT..02 K070421 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Healthcare. Cleared Mar 2007. https://www.510kdatabase.net/k063712/ 2007-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k063712-avaulta-support-systemavaulta-plus-fda-510k.jpg K063712 - AVAULTA SUPPORT SYSTEM/AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM K063712 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 2007. https://www.510kdatabase.net/k070083/ 2007-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k070083-quanta-lite-h-ttgdgp-screen-fda-510k.jpg K070083 - QUANTA LITE H-TTG/DGP SCREEN K070083 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Mar 2007. https://www.510kdatabase.net/k070369/ 2007-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k070369-regenerx-ringloc-modular-acetabular-fda-510k.jpg K070369 - REGENERX RINGLOC + MODULAR ACETABULAR SHELLS K070369 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Mar 2007. https://www.510kdatabase.net/k070508/ 2007-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k070508-bardex-lubri-sil-all-silicone-fda-510k.jpg K070508 - BARDEX LUBRI-SIL ALL-SILICONE LUBRICIOUS COATED FOLEY CATHETER 6 FR K070508 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 2007. https://www.510kdatabase.net/k063445/ 2007-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k063445-pca-constrained-acetabular-liners-fda-510k.jpg K063445 - PCA CONSTRAINED ACETABULAR LINERS K063445 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Mar 2007. https://www.510kdatabase.net/k063473/ 2007-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k063473-synthes-orthodontic-bone-anchor-system-fda-510k.jpg K063473 - SYNTHES ORTHODONTIC BONE ANCHOR SYSTEM K063473 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Mar 2007. https://www.510kdatabase.net/k063550/ 2007-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k063550-system-12-constrained-acetabular-liners-fda-510k.jpg K063550 - SYSTEM 12 CONSTRAINED ACETABULAR LINERS K063550 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Mar 2007. https://www.510kdatabase.net/k063552/ 2007-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k063552-series-ii-constrained-acetabular-liners-fda-510k.jpg K063552 - SERIES II CONSTRAINED ACETABULAR LINERS K063552 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Mar 2007. https://www.510kdatabase.net/k063486/ 2007-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k063486-bd-phoenix-automated-microbiology-fda-510k.jpg K063486 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM MINOCYCLINE (1-32 UG/ML) GRAM NEGATIVE ID/AST OR AST ONLY K063486 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Mar 2007. https://www.510kdatabase.net/k063689/ 2007-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k063689-bd-directigen-ez-flu-ab-test-fda-510k.jpg K063689 - BD DIRECTIGEN EZ FLU A+B TEST K063689 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Mar 2007. https://www.510kdatabase.net/k063832/ 2007-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k063832-synthes-usa-elbow-hinge-fixator-fda-510k.jpg K063832 - SYNTHES (USA) ELBOW HINGE FIXATOR K063832 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Mar 2007. https://www.510kdatabase.net/k063719/ 2007-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k063719-arthrex-crosspin-model-ar-1964p-fda-510k.jpg K063719 - ARTHREX CROSSPIN, MODEL AR-1964P K063719 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Mar 2007. https://www.510kdatabase.net/k070359/ 2007-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k070359-depuy-asr-taper-sleeve-adapter-fda-510k.jpg K070359 - DEPUY ASR TAPER SLEEVE ADAPTER K070359 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Mar 2007. https://www.510kdatabase.net/k063491/ 2007-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k063491-t2-sceptor-spinal-system-fda-510k.jpg K063491 - T2 SCEPTOR SPINAL SYSTEM K063491 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Mar 2007. https://www.510kdatabase.net/k063633/ 2007-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k063633-depuy-knee-prosthesis-system-universal-fda-510k.jpg K063633 - DEPUY KNEE PROSTHESIS SYSTEM UNIVERSAL STEM EXTENSIONS AND FEMORAL METAPHYSEAL SLEEVES K063633 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Mar 2007. https://www.510kdatabase.net/k063731/ 2007-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k063731-advance-stature-femoral-component-fda-510k.jpg K063731 - ADVANCE STATURE FEMORAL COMPONENT K063731 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Mar 2007. https://www.510kdatabase.net/k070294/ 2007-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k070294-synthes-trochanteric-fixation-nail-tfn-fda-510k.jpg K070294 - SYNTHES TROCHANTERIC FIXATION NAIL (TFN) SYSTEM, ADDITIONAL HELICAL BLADES K070294 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Mar 2007. https://www.510kdatabase.net/k062789/ 2007-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k062789-synthes-usa-rapid-resorbable-fixation-fda-510k.jpg K062789 - SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM K062789 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Feb 2007. https://www.510kdatabase.net/k070322/ 2007-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k070322-syngo-dynamics-version-60-fda-510k.jpg K070322 - SYNGO DYNAMICS, VERSION 6.0 K070322 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 2007. https://www.510kdatabase.net/k063535/ 2007-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k063535-caption-applicator-fda-510k.jpg K063535 - CAPTION APPLICATOR K063535 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Feb 2007. https://www.510kdatabase.net/k063562/ 2007-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k063562-gynecare-prosima-pelvic-floor-repair-fda-510k.jpg K063562 - GYNECARE PROSIMA PELVIC FLOOR REPAIR SYSTEMS K063562 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ethicon, Inc.. Cleared Feb 2007. https://www.510kdatabase.net/k063857/ 2007-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k063857-simplex-p-speedset-with-tobramycin-fda-510k.jpg K063857 - SIMPLEX P SPEEDSET WITH TOBRAMYCIN BONE CEMENT K063857 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Feb 2007. https://www.510kdatabase.net/k061991/ 2007-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k061991-plateletworks-arachidonic-acid-model-fda-510k.jpg K061991 - PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA K061991 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Feb 2007. https://www.510kdatabase.net/k063023/ 2007-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k063023-3m-health-care-particulate-respirator-fda-510k.jpg K063023 - 3M HEALTH CARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODEL 1870 K063023 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Feb 2007. https://www.510kdatabase.net/k063569/ 2007-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k063569-equinoxe-reverse-shoulder-system-fda-510k.jpg K063569 - EQUINOXE REVERSE SHOULDER SYSTEM K063569 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Feb 2007. https://www.510kdatabase.net/k063608/ 2007-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k063608-dimension-vista-apoa1-and-apob-flex-fda-510k.jpg K063608 - DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH K063608 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Feb 2007. https://www.510kdatabase.net/k063754/ 2007-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k063754-dimension-vista-tm-bhcg-flexr-reagent-fda-510k.jpg K063754 - DIMENSION VISTA (TM) BHCG FLEX(R) REAGENT CARTRIDGE, AND BHCG CALIBRATOR, MODEL# K6430,KC632 K063754 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Feb 2007. https://www.510kdatabase.net/k070301/ 2007-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k070301-hemosil-antithrombin-fda-510k.jpg K070301 - HEMOSIL ANTITHROMBIN K070301 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Feb 2007. https://www.510kdatabase.net/k063540/ 2007-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k063540-bipap-autosv-fda-510k.jpg K063540 - BIPAP AUTOSV K063540 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Feb 2007. https://www.510kdatabase.net/k070266/ 2007-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k070266-560-high-definition-camera-system-fda-510k.jpg K070266 - 560 HIGH DEFINITION CAMERA SYSTEM K070266 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Feb 2007. https://www.510kdatabase.net/k063533/ 2007-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k063533-bipap-synchrony-fda-510k.jpg K063533 - BIPAP SYNCHRONY K063533 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Feb 2007. https://www.510kdatabase.net/k062464/ 2007-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k062464-modification-to-autocon-ii-400-fda-510k.jpg K062464 - MODIFICATION TO AUTOCON II 400 ELECTROSURGICAL GENERATOR K062464 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Feb 2007. https://www.510kdatabase.net/k063520/ 2007-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k063520-roche-total-mycophenolic-acid-assay-fda-510k.jpg K063520 - ROCHE TOTAL MYCOPHENOLIC ACID ASSAY, CALIBRATORS AND CONTROLS K063520 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics. Cleared Feb 2007. https://www.510kdatabase.net/k063425/ 2007-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k063425-dimension-vista-ige-flex-reagent-fda-510k.jpg K063425 - DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGH K063425 is a FDA 510(k) cleared immunology medical device. Manufacturer: Dade Behring, Inc.. Cleared Feb 2007. https://www.510kdatabase.net/k063655/ 2007-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k063655-dimension-vista-fda-510k.jpg K063655 - DIMENSION VISTA K063655 is a FDA 510(k) cleared immunology medical device. Manufacturer: Dade Behring, Inc.. Cleared Feb 2007. https://www.510kdatabase.net/k062569/ 2007-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k062569-safeguard-24-cm-pressure-assisted-fda-510k.jpg K062569 - SAFEGUARD 24 CM PRESSURE ASSISTED DRESSING K062569 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Feb 2007. https://www.510kdatabase.net/k063824/ 2007-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k063824-bd-phoenix-automated-microbiology-fda-510k.jpg K063824 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AZTREONAM (GN) 0.5-64UG/ML K063824 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Feb 2007. https://www.510kdatabase.net/k063118/ 2007-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k063118-bard-balloon-dilation-kit-with-fda-510k.jpg K063118 - BARD BALLOON DILATION KIT WITH TRIFUNNEL GASTROSTOMY TUBE K063118 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Feb 2007. https://www.510kdatabase.net/k062012/ 2007-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k062012-s4-cervical-occipital-plate-spinal-fda-510k.jpg K062012 - S4 CERVICAL OCCIPITAL PLATE SPINAL SYSTEM K062012 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aesculap, Inc.. Cleared Feb 2007. https://www.510kdatabase.net/k063811/ 2007-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k063811-bd-phoenix-automated-microbiology-fda-510k.jpg K063811 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFAZOLIN (GN) 0.5-32UG/ML K063811 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Feb 2007. https://www.510kdatabase.net/k070094/ 2007-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k070094-trilogy-radiotherapy-delivery-system-fda-510k.jpg K070094 - TRILOGY RADIOTHERAPY DELIVERY SYSTEM AND TRILOGY TX DELIVERY SYSTEM K070094 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Feb 2007. https://www.510kdatabase.net/k063564/ 2007-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k063564-microscan-synergies-plus-gram-positive-fda-510k.jpg K063564 - MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH CHLORAMPHENICOL (4-16 UG/ML) K063564 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Feb 2007. https://www.510kdatabase.net/k062098/ 2007-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k062098-spectrum-monitor-model-0998-00-1000-fda-510k.jpg K062098 - SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX K062098 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Feb 2007. https://www.510kdatabase.net/k062250/ 2007-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k062250-delta-xtend-reverse-shoulder-system-fda-510k.jpg K062250 - DELTA XTEND REVERSE SHOULDER SYSTEM K062250 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Feb 2007. https://www.510kdatabase.net/k063652/ 2007-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k063652-global-ap-porous-coated-humeral-stem-fda-510k.jpg K063652 - GLOBAL AP POROUS COATED HUMERAL STEM K063652 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Feb 2007. https://www.510kdatabase.net/k070144/ 2007-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k070144-inhibin-a-calibrators-controls-on-the-fda-510k.jpg K070144 - INHIBIN A CALIBRATORS & CONTROLS ON THE ACCESS IMMUNOASSAY SYSTEMS K070144 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Feb 2007. https://www.510kdatabase.net/k062114/ 2007-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k062114-ceruloplasmin-model-2055953-fda-510k.jpg K062114 - CERULOPLASMIN, MODEL 2055953 K062114 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jan 2007. https://www.510kdatabase.net/k062379/ 2007-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k062379-cobas-integra-ceruloplasmin-fda-510k.jpg K062379 - COBAS INTEGRA CERULOPLASMIN K062379 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jan 2007. https://www.510kdatabase.net/k063585/ 2007-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k063585-karl-storz-video-lower-gi-endoscope-fda-510k.jpg K063585 - KARL STORZ VIDEO LOWER G.I. ENDOSCOPE SYSTEM K063585 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jan 2007. https://www.510kdatabase.net/k062925/ 2007-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k062925-coaguchek-xs-system-fda-510k.jpg K062925 - COAGUCHEK XS SYSTEM K062925 is a FDA 510(k) cleared hematology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jan 2007. https://www.510kdatabase.net/k063300/ 2007-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k063300-bd-phoenix-automated-microbiology-fda-510k.jpg K063300 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFPODOXIME (GN) 0.125-8UG/ML K063300 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Jan 2007. https://www.510kdatabase.net/k063823/ 2007-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k063823-coaguchek-xs-pt-controls-fda-510k.jpg K063823 - COAGUCHEK XS PT CONTROLS K063823 is a FDA 510(k) cleared hematology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jan 2007. https://www.510kdatabase.net/k061499/ 2007-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k061499-osferion-fda-510k.jpg K061499 - OSFERION K061499 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Olympus America, Inc.. Cleared Jan 2007. https://www.510kdatabase.net/k063272/ 2007-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k063272-dimension-vista-b2mic-flex-reagent-fda-510k.jpg K063272 - DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL MEDIUM, CONTROL HIGH K063272 is a FDA 510(k) cleared immunology medical device. Manufacturer: Dade Behring, Inc.. Cleared Jan 2007. https://www.510kdatabase.net/k070019/ 2007-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k070019-carrara-volumia-fda-510k.jpg K070019 - CARRARA VOLUMIA K070019 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jan 2007. https://www.510kdatabase.net/k052973/ 2007-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k052973-ipump-pain-management-system-model-fda-510k.jpg K052973 - IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107, 2L3107K K052973 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jan 2007. https://www.510kdatabase.net/k063377/ 2007-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k063377-powerport-polymetric-port-with-8-fr-sl-fda-510k.jpg K063377 - POWERPORT POLYMETRIC PORT WITH 8 FR S/L CHRONOFLEX CATHETER K063377 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 2007. https://www.510kdatabase.net/k063251/ 2007-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k063251-zimmer-ml-taper-hip-prosthesis-with-fda-510k.jpg K063251 - ZIMMER M/L TAPER HIP PROSTHESIS WITH MODULAR NECK TECHNOLOGY K063251 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jan 2007. https://www.510kdatabase.net/k063322/ 2007-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k063322-dimension-vista-trf-flex-reagent-fda-510k.jpg K063322 - DIMENSION VISTA TRF FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR PROTEIN 1 CONTROL L,CONTROL M, CONTROL H K063322 is a FDA 510(k) cleared immunology medical device. Manufacturer: Dade Behring, Inc.. Cleared Jan 2007. https://www.510kdatabase.net/k063508/ 2007-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k063508-dimension-vista-protein-1-calibrator-fda-510k.jpg K063508 - DIMENSION VISTA PROTEIN 1 CALIBRATOR AND CONTROL L, M, H K063508 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Jan 2007. https://www.510kdatabase.net/k063351/ 2007-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k063351-dimension-vista-cysc-flex-reagent-fda-510k.jpg K063351 - DIMENSION VISTA CYSC FLEX REAGENT CARTRIDGE, PROTEIN 3 CALIBRATOR AND CYSTATIN CONTROL LOW AND HIGH K063351 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Jan 2007. https://www.510kdatabase.net/k062849/ 2007-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k062849-smith-nephew-duonics-power-ii-shaver-fda-510k.jpg K062849 - SMITH & NEPHEW DUONICS POWER II SHAVER SYSTEM K062849 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jan 2007. https://www.510kdatabase.net/k063372/ 2007-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k063372-radifocus-glidewire-advantage-fda-510k.jpg K063372 - RADIFOCUS GLIDEWIRE ADVANTAGE K063372 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Jan 2007. https://www.510kdatabase.net/k063597/ 2007-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k063597-vitek-2-gram-positive-amoxicillin-for-fda-510k.jpg K063597 - VITEK 2 GRAM POSITIVE AMOXICILLIN FOR STREPTOCOCCUS PNEUMONIAE K063597 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jan 2007. https://www.510kdatabase.net/k063417/ 2007-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k063417-modification-to-cd-horizon-spinal-system-fda-510k.jpg K063417 - MODIFICATION TO CD HORIZON SPINAL SYSTEM K063417 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Jan 2007. https://www.510kdatabase.net/k062009/ 2007-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k062009-aesculap-meithke-progav-programmable-fda-510k.jpg K062009 - AESCULAP-MEITHKE PROGAV PROGRAMMABLE VALVE, MODELS FV410T-FV451T K062009 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Jan 2007. https://www.510kdatabase.net/k062358/ 2007-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k062358-modification-to-vectorvision-trauma-fda-510k.jpg K062358 - MODIFICATION TO VECTORVISION TRAUMA K062358 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Jan 2007. https://www.510kdatabase.net/k062918/ 2007-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k062918-karl-storz-flexible-video-urethro-fda-510k.jpg K062918 - KARL STORZ FLEXIBLE VIDEO-URETHRO-CYSTOSCOPE SYSTEM K062918 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jan 2007. https://www.510kdatabase.net/k063217/ 2007-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k063217-venatech-lp-brachial-introducer-system-fda-510k.jpg K063217 - VENATECH LP BRACHIAL INTRODUCER SYSTEM (ANTECUBITAL) K063217 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Jan 2007. https://www.510kdatabase.net/k063679/ 2007-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k063679-acl-top-fda-510k.jpg K063679 - ACL TOP K063679 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jan 2007. https://www.510kdatabase.net/k063826/ 2007-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k063826-syngo-mi-applications-2007a-fda-510k.jpg K063826 - SYNGO MI APPLICATIONS 2007A K063826 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 2007. https://www.510kdatabase.net/k063573/ 2007-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k063573-bd-phoenix-automated-microbiology-fda-510k.jpg K063573 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFTAZIDIME (GN) 0.5-64 UG/ML K063573 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Jan 2007. https://www.510kdatabase.net/k063610/ 2007-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k063610-dimension-vista-a1at-flex-reagent-fda-510k.jpg K063610 - DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH K063610 is a FDA 510(k) cleared immunology medical device. Manufacturer: Dade Behring, Inc.. Cleared Jan 2007. https://www.510kdatabase.net/k063623/ 2007-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k063623-vitek-2-gram-positive-meropenem-for-fda-510k.jpg K063623 - VITEK 2 GRAM POSITIVE MEROPENEM FOR STREPTOCOCCUS PNEUMONIAE K063623 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jan 2007. https://www.510kdatabase.net/k060415/ 2007-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k060415-modification-to-satellite-spinal-system-fda-510k.jpg K060415 - MODIFICATION TO: SATELLITE SPINAL SYSTEM K060415 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Jan 2007. https://www.510kdatabase.net/k063181/ 2007-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k063181-synthes-usa-condylar-head-add-on-system-fda-510k.jpg K063181 - SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM K063181 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Jan 2007. https://www.510kdatabase.net/k063525/ 2007-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k063525-datascope-fiber-optic-pressure-sensor-fda-510k.jpg K063525 - DATASCOPE FIBER OPTIC PRESSURE SENSOR INTRA-AORTIC BALLOON CATHETER AND CS300 INTRA-AORTIC BALLOON PUMP CONTROL SYSTEM K063525 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Jan 2007. https://www.510kdatabase.net/k063632/ 2007-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k063632-x-force-n30-nephrostomy-balloon-fda-510k.jpg K063632 - X-FORCE N30 NEPHROSTOMY BALLOON DILATION CATHETER K063632 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 2007. https://www.510kdatabase.net/k063509/ 2007-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k063509-depuy-peak-fx-hip-plate-fda-510k.jpg K063509 - DEPUY PEAK FX HIP PLATE K063509 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jan 2007. https://www.510kdatabase.net/k063761/ 2007-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k063761-acuson-p10-diagnostic-ultrasound-system-fda-510k.jpg K063761 - ACUSON P10 DIAGNOSTIC ULTRASOUND SYSTEM K063761 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 2007. https://www.510kdatabase.net/k063058/ 2007-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k063058-arthrex-anatoemic-phalangeal-prosthesis-fda-510k.jpg K063058 - ARTHREX ANATOEMIC PHALANGEAL PROSTHESIS K063058 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jan 2007. https://www.510kdatabase.net/k063206/ 2006-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k063206-dimension-vista-hcys-flex-reagent-fda-510k.jpg K063206 - DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE K063206 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Dec 2006. https://www.510kdatabase.net/k062115/ 2006-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k062115-carbon-dioxide-monitor-model-olg-2800a-fda-510k.jpg K062115 - CARBON DIOXIDE MONITOR, MODEL OLG-2800A K062115 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Dec 2006. https://www.510kdatabase.net/k063017/ 2006-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k063017-aesculap-sternumfix-sternal-closure-fda-510k.jpg K063017 - AESCULAP STERNUMFIX STERNAL CLOSURE SYSTEM K063017 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aesculap, Inc.. Cleared Dec 2006. https://www.510kdatabase.net/k063225/ 2006-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k063225-metaizeau-nailing-system-fda-510k.jpg K063225 - METAIZEAU NAILING SYSTEM K063225 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Dec 2006. https://www.510kdatabase.net/k062924/ 2006-12-26 monthly 0.5 https://www.510kdatabase.net/og-image/k062924-stratus-cs-acute-care-cardiophase-fda-510k.jpg K062924 - STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK K062924 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Dec 2006. https://www.510kdatabase.net/k063613/ 2006-12-26 monthly 0.5 https://www.510kdatabase.net/og-image/k063613-modification-to-terumo-syringe-fda-510k.jpg K063613 - MODIFICATION TO TERUMO SYRINGE WITH/WITHOUT NEEDLE K063613 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terumo Medical Corp.. Cleared Dec 2006. https://www.510kdatabase.net/k061841/ 2006-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k061841-quanta-lite-intrinsic-factor-elisa-fda-510k.jpg K061841 - QUANTA LITE INTRINSIC FACTOR ELISA K061841 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Dec 2006. https://www.510kdatabase.net/k063543/ 2006-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k063543-cobas-integra-bilirubin-special-and-fda-510k.jpg K063543 - COBAS INTEGRA BILIRUBIN SPECIAL AND ROCHE/HITACHI BILRUBIN TOTAL, MODELS 20737496 322, 03261638 190, AND 11822713 226 K063543 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Dec 2006. https://www.510kdatabase.net/k063055/ 2006-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k063055-vs-800-vital-signs-monitor-fda-510k.jpg K063055 - VS-800 VITAL SIGNS MONITOR K063055 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Dec 2006. https://www.510kdatabase.net/k063492/ 2006-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k063492-vitek-2-gram-positive-erythromycin-for-fda-510k.jpg K063492 - VITEK 2 GRAM POSITIVE ERYTHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE K063492 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Dec 2006. https://www.510kdatabase.net/k063493/ 2006-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k063493-i-review-softwareaccessory-to-ilab-fda-510k.jpg K063493 - I REVIEW SOFTWARE(ACCESSORY TO) ILAB ULTRASOUND IMAGING SYSTEM) VERSION1.0 K063493 is a FDA 510(k) cleared radiology medical device. Manufacturer: Boston Scientific Corp. Cleared Dec 2006. https://www.510kdatabase.net/k061461/ 2006-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k061461-mayo-conservative-hip-prosthesis-model-fda-510k.jpg K061461 - MAYO CONSERVATIVE HIP PROSTHESIS, MODEL 00.65-8026-010-05 K061461 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Dec 2006. https://www.510kdatabase.net/k063616/ 2006-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k063616-trident-ii-acetabular-system-fda-510k.jpg K063616 - TRIDENT II ACETABULAR SYSTEM K063616 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Dec 2006. https://www.510kdatabase.net/k063619/ 2006-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k063619-flipper-detachable-embolization-coils-fda-510k.jpg K063619 - FLIPPER DETACHABLE EMBOLIZATION COILS K063619 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Dec 2006. https://www.510kdatabase.net/k062836/ 2006-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k062836-citadel-anterior-lumbar-plate-system-fda-510k.jpg K062836 - CITADEL ANTERIOR LUMBAR PLATE SYSTEM K062836 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Dec 2006. https://www.510kdatabase.net/k060794/ 2006-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k060794-progenix-dbm-putty-and-paste-fda-510k.jpg K060794 - PROGENIX DBM PUTTY AND PASTE K060794 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Dec 2006. https://www.510kdatabase.net/k063049/ 2006-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k063049-synthes-usa-modular-mini-fragment-lcp-fda-510k.jpg K063049 - SYNTHES (USA) MODULAR MINI FRAGMENT LCP SYSTEM K063049 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Dec 2006. https://www.510kdatabase.net/k062426/ 2006-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k062426-depuy-pinnacle-metal-on-metal-fda-510k.jpg K062426 - DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS K062426 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Dec 2006. https://www.510kdatabase.net/k063446/ 2006-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k063446-catheter-repair-kit-with-replacement-fda-510k.jpg K063446 - CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 K063446 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 2006. https://www.510kdatabase.net/k062969/ 2006-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k062969-medline-sterile-disposable-surgical-fda-510k.jpg K062969 - MEDLINE STERILE DISPOSABLE SURGICAL GOWNS K062969 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Dec 2006. https://www.510kdatabase.net/k063270/ 2006-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k063270-rpm-respiratory-gating-system-fda-510k.jpg K063270 - RPM RESPIRATORY GATING SYSTEM K063270 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Dec 2006. https://www.510kdatabase.net/k062708/ 2006-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k062708-quanta-lite-celiac-dgp-screen-fda-510k.jpg K062708 - QUANTA LITE CELIAC DGP SCREEN K062708 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Dec 2006. https://www.510kdatabase.net/k062845/ 2006-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k062845-modular-replacement-elbow-system-fda-510k.jpg K062845 - MODULAR REPLACEMENT ELBOW SYSTEM K062845 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Dec 2006. https://www.510kdatabase.net/k063479/ 2006-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k063479-arthrex-pushlock-fda-510k.jpg K063479 - ARTHREX PUSHLOCK K063479 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Dec 2006. https://www.510kdatabase.net/k063028/ 2006-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k063028-vectorvision-hip-sr-fda-510k.jpg K063028 - VECTORVISION HIP SR K063028 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Dec 2006. https://www.510kdatabase.net/k061533/ 2006-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k061533-proceed-ventral-patch-fda-510k.jpg K061533 - PROCEED VENTRAL PATCH K061533 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Dec 2006. https://www.510kdatabase.net/k062986/ 2006-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k062986-medtronic-graft-delivery-syringe-fda-510k.jpg K062986 - MEDTRONIC GRAFT DELIVERY SYRINGE K062986 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Dec 2006. https://www.510kdatabase.net/k063301/ 2006-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k063301-bd-phoenix-automated-microbiology-fda-510k.jpg K063301 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFEPIME (GN) 0.5-64UG/ML K063301 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Dec 2006. https://www.510kdatabase.net/k063365/ 2006-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k063365-synergies-plus-gram-positive-miccombo-fda-510k.jpg K063365 - SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH GENTAMICIN (0.06-32MG/ML LONG DILUTION SEQUENCE K063365 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Dec 2006. https://www.510kdatabase.net/k063366/ 2006-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k063366-microscan-synergies-plus-gram-positive-fda-510k.jpg K063366 - MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANEL WITH SYNERCID (0.12-2UG/ML 5DILUTION BREAKPOINT SEQUENCE K063366 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Dec 2006. https://www.510kdatabase.net/k061844/ 2006-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k061844-dynasty-acetabular-shell-and-cocr-fda-510k.jpg K061844 - DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINER K061844 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Dec 2006. https://www.510kdatabase.net/k062324/ 2006-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k062324-mri-monitor-with-l-cane05-and-l-fda-510k.jpg K062324 - MRI MONITOR WITH L-CANE05 AND L-CANE05A SOFTWARE AND MODULE OPTIONS N-PSNGV, N-PSNG, N-SNGV, N-SNG, N-PSN, N-SN K062324 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Healthcare. Cleared Dec 2006. https://www.510kdatabase.net/k063500/ 2006-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k063500-dc-6-diagnostic-ultrasound-system-fda-510k.jpg K063500 - DC-6 DIAGNOSTIC ULTRASOUND SYSTEM K063500 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Dec 2006. https://www.510kdatabase.net/k063045/ 2006-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k063045-immulite-2000-immulite-2500-vancomycin-fda-510k.jpg K063045 - IMMULITE 2000, IMMULITE 2500 VANCOMYCIN K063045 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Dec 2006. https://www.510kdatabase.net/k063313/ 2006-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k063313-filterwire-ez-embolic-protection-fda-510k.jpg K063313 - FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (3.5 MM TO 5.5 MM) K063313 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Dec 2006. https://www.510kdatabase.net/k062750/ 2006-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k062750-wallflex-enteral-duodenal-stent-with-fda-510k.jpg K062750 - WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030 K062750 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Dec 2006. https://www.510kdatabase.net/k062960/ 2006-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k062960-conserve-femoral-resurfacing-component-fda-510k.jpg K062960 - CONSERVE FEMORAL RESURFACING COMPONENT K062960 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Dec 2006. https://www.510kdatabase.net/k063062/ 2006-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k063062-hkbond-2006-fda-510k.jpg K063062 - HKBOND 2006 K063062 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Dec 2006. https://www.510kdatabase.net/k063220/ 2006-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k063220-da-vinci-s-surgical-system-v11-model-fda-510k.jpg K063220 - DA VINCI S SURGICAL SYSTEM-V1.1, MODEL IS2000 K063220 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Dec 2006. https://www.510kdatabase.net/k062748/ 2006-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k062748-modification-to-depuy-delta-ceramic-fda-510k.jpg K062748 - MODIFICATION: TO DEPUY DELTA CERAMIC FEMORAL HEAD K062748 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Nov 2006. https://www.510kdatabase.net/k063312/ 2006-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k063312-modification-to-atlantis-sr-pro-2-and-fda-510k.jpg K063312 - MODIFICATION TO ATLANTIS SR PRO 2 AND SR PRO CORONARY IMAGING CATHETERS, MODEL 39014 AND 38942 K063312 is a FDA 510(k) cleared radiology medical device. Manufacturer: Boston Scientific Corp. Cleared Nov 2006. https://www.510kdatabase.net/k062466/ 2006-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k062466-arthrex-interference-screw-fda-510k.jpg K062466 - ARTHREX INTERFERENCE SCREW K062466 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Nov 2006. https://www.510kdatabase.net/k062581/ 2006-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k062581-olympus-tsh-reagent-calibrator-and-fda-510k.jpg K062581 - OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM K062581 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus America, Inc.. Cleared Nov 2006. https://www.510kdatabase.net/k063279/ 2006-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k063279-novation-splined-rdd-femoral-stems-fda-510k.jpg K063279 - NOVATION SPLINED RDD FEMORAL STEMS K063279 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Nov 2006. https://www.510kdatabase.net/k063435/ 2006-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k063435-gore-dualmesh-plus-biomaterial-gore-fda-510k.jpg K063435 - GORE DUALMESH PLUS BIOMATERIAL GORE MYCROMESH PLUS BIOMATERIAL K063435 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Nov 2006. https://www.510kdatabase.net/k063299/ 2006-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k063299-microscan-microstrep-plus-panel-fda-510k.jpg K063299 - MICROSCAN MICROSTREP PLUS PANEL-CLARITHROMYCIN K063299 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Nov 2006. https://www.510kdatabase.net/k062684/ 2006-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k062684-excia-total-hip-system-36mm-ceramic-head-fda-510k.jpg K062684 - EXCIA TOTAL HIP SYSTEM 36MM CERAMIC HEAD K062684 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aesculap, Inc.. Cleared Nov 2006. https://www.510kdatabase.net/k062855/ 2006-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k062855-calcium-fda-510k.jpg K062855 - CALCIUM K062855 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Nov 2006. https://www.510kdatabase.net/k063138/ 2006-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k063138-modification-to-acuson-antares-fda-510k.jpg K063138 - MODIFICATION TO ACUSON ANTARES ULTRASOUND SYSTEM K063138 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2006. https://www.510kdatabase.net/k063303/ 2006-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k063303-universal-locking-system-27mm-plates-fda-510k.jpg K063303 - UNIVERSAL LOCKING SYSTEM, 2.7MM PLATES & SCREWS K063303 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Nov 2006. https://www.510kdatabase.net/k062413/ 2006-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k062413-aesculap-pneumatic-kerrison-fda-510k.jpg K062413 - AESCULAP PNEUMATIC KERRISON K062413 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Nov 2006. https://www.510kdatabase.net/k062945/ 2006-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k062945-bd-phoenix-automated-microbiology-fda-510k.jpg K062945 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERTAPENEM (GN) 0.25-32 UG/ML K062945 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Nov 2006. https://www.510kdatabase.net/k063178/ 2006-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k063178-bard-collamend-implant-models-1175102-fda-510k.jpg K063178 - BARD COLLAMEND IMPLANT, MODELS 1175102, 1175103, 1175104, 1175105, 1175106 K063178 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 2006. https://www.510kdatabase.net/k063240/ 2006-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k063240-sherlock-tls-stylet-sherlock-tls-fda-510k.jpg K063240 - SHERLOCK TLS STYLET, SHERLOCK TLS DETECTOR K063240 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 2006. https://www.510kdatabase.net/k063361/ 2006-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k063361-excelart-vantage-atlas-model-mrt-1503-fda-510k.jpg K063361 - EXCELART VANTAGE ATLAS, MODEL MRT-1503 K063361 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Nov 2006. https://www.510kdatabase.net/k063467/ 2006-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k063467-smith-nephew-rf-cannulae-fda-510k.jpg K063467 - SMITH & NEPHEW RF CANNULAE K063467 is a FDA 510(k) cleared neurology medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Nov 2006. https://www.510kdatabase.net/k062938/ 2006-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k062938-microscan-synergies-plus-gram-positive-fda-510k.jpg K062938 - MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH NITROFURANTOIN (2 - 256 UG/ML K062938 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Nov 2006. https://www.510kdatabase.net/k063280/ 2006-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k063280-injekt-syringe-fda-510k.jpg K063280 - INJEKT SYRINGE K063280 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Nov 2006. https://www.510kdatabase.net/k062419/ 2006-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k062419-trident-large-diameter-acetabular-fda-510k.jpg K062419 - TRIDENT LARGE DIAMETER ACETABULAR INSERTS K062419 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Nov 2006. https://www.510kdatabase.net/k062944/ 2006-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k062944-bd-phoenix-automated-microbiology-fda-510k.jpg K062944 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTRIAXONE (GN) 0.5-64UG/ML K062944 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Nov 2006. https://www.510kdatabase.net/k063085/ 2006-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k063085-modification-to-acuson-sequoia-fda-510k.jpg K063085 - MODIFICATION TO ACUSON SEQUOIA ULTRASOUND SYSTEM K063085 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2006. https://www.510kdatabase.net/k063252/ 2006-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k063252-atb-advanced-pta-dilatation-catheter-fda-510k.jpg K063252 - ATB ADVANCED PTA DILATATION CATHETER K063252 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Nov 2006. https://www.510kdatabase.net/k062984/ 2006-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k062984-medline-hypodermic-needles-fda-510k.jpg K062984 - MEDLINE HYPODERMIC NEEDLES K062984 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Nov 2006. https://www.510kdatabase.net/k060907/ 2006-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k060907-karl-storz-video-gastroscopes-fda-510k.jpg K060907 - KARL STORZ VIDEO GASTROSCOPES K060907 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Nov 2006. https://www.510kdatabase.net/k062161/ 2006-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k062161-gore-propaten-vascular-graft-fda-510k.jpg K062161 - GORE PROPATEN VASCULAR GRAFT K062161 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Nov 2006. https://www.510kdatabase.net/k063102/ 2006-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k063102-microscan-microstrep-plus-panel-fda-510k.jpg K063102 - MICROSCAN MICROSTREP PLUS PANEL CEFACLOR (0.5 - 8 MCG/ML) K063102 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Nov 2006. https://www.510kdatabase.net/k063241/ 2006-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k063241-cstc-002a-extended-field-of-view-fda-510k.jpg K063241 - CSTC-002A, EXTENDED FIELD OF VIEW SOFTWARE OPTION K063241 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Nov 2006. https://www.510kdatabase.net/k062228/ 2006-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k062228-zimmer-hip-computer-assisted-solutions-fda-510k.jpg K062228 - ZIMMER HIP COMPUTER ASSISTED SOLUTIONS ELECTROMAGNETIC AND IMAGELESS INSTRUMENTATION K062228 is a FDA 510(k) cleared neurology medical device. Manufacturer: Zimmer, Inc.. Cleared Nov 2006. https://www.510kdatabase.net/k063184/ 2006-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k063184-model-cvv-001a-vessel-view-software-fda-510k.jpg K063184 - MODEL CVV-001A VESSEL VIEW SOFTWARE OPTION K063184 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Nov 2006. https://www.510kdatabase.net/k063189/ 2006-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k063189-tsx-301a-aquilion-one-ct-system-fda-510k.jpg K063189 - TSX-301A, AQUILION ONE CT SYSTEM K063189 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Nov 2006. https://www.510kdatabase.net/k061288/ 2006-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k061288-auto-suture-endo-clip-iii-5-mm-clip-fda-510k.jpg K061288 - AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER K061288 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Nov 2006. https://www.510kdatabase.net/k061316/ 2006-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k061316-medline-surgical-sponge-scanner-fda-510k.jpg K061316 - MEDLINE SURGICAL SPONGE SCANNER K061316 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medline Industries, Inc.. Cleared Nov 2006. https://www.510kdatabase.net/k062754/ 2006-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k062754-gas-module-se-model-0998-00-0481-02-fda-510k.jpg K062754 - GAS MODULE SE, MODEL 0998-00-0481-02 K062754 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Datascope Corp.. Cleared Nov 2006. https://www.510kdatabase.net/k063006/ 2006-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k063006-ge-logiq-works-fda-510k.jpg K063006 - GE LOGIQ WORKS K063006 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Nov 2006. https://www.510kdatabase.net/k063099/ 2006-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k063099-microscan-microstrep-plus-panel-fda-510k.jpg K063099 - MICROSCAN MICROSTREP PLUS PANEL CEFEPIME (O.015 - 8 MCG/ML) K063099 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Nov 2006. https://www.510kdatabase.net/k063101/ 2006-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k063101-microscan-microstrep-plus-panel-fda-510k.jpg K063101 - MICROSCAN MICROSTREP PLUS PANEL CEFOTAXIME (0.015 - 8 MCG/ML K063101 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Nov 2006. https://www.510kdatabase.net/k061925/ 2006-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k061925-mini-tightrope-repair-kit-model-ar-fda-510k.jpg K061925 - MINI TIGHTROPE REPAIR KIT, MODEL AR-8911DS K061925 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Oct 2006. https://www.510kdatabase.net/k063065/ 2006-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k063065-microscan-microstrep-plus-panel-fda-510k.jpg K063065 - MICROSCAN MICROSTREP PLUS PANEL MEROPENEM (0.03-4MCG/ML) K063065 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Oct 2006. https://www.510kdatabase.net/k062375/ 2006-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k062375-microscan-microstrep-plus-panel-fda-510k.jpg K062375 - MICROSCAN MICROSTREP PLUS PANEL ERYTHROMYCIN (0.015 TO 2 MCG/ML) K062375 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Oct 2006. https://www.510kdatabase.net/k062699/ 2006-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k062699-perfusor-space-infusion-syringe-pump-fda-510k.jpg K062699 - PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM K062699 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Oct 2006. https://www.510kdatabase.net/k062700/ 2006-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k062700-infusomat-space-volumetric-infusion-fda-510k.jpg K062700 - INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM K062700 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Oct 2006. https://www.510kdatabase.net/k063053/ 2006-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k063053-microscan-microstrep-plus-panel-fda-510k.jpg K063053 - MICROSCAN MICROSTREP PLUS PANEL CEFUROXIME (0.12-8 MCG/ML) K063053 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Oct 2006. https://www.510kdatabase.net/k063064/ 2006-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k063064-microscan-microstrep-plus-panel-fda-510k.jpg K063064 - MICROSCAN MICROSTREP PLUS PANEL CEFTRIAXONE (0.015-8MCG/ML) K063064 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Oct 2006. https://www.510kdatabase.net/k060615/ 2006-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k060615-cd-horizon-spinal-system-fda-510k.jpg K060615 - CD HORIZON SPINAL SYSTEM K060615 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Oct 2006. https://www.510kdatabase.net/k061416/ 2006-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k061416-selectsite-c304-deflectable-catheter-fda-510k.jpg K061416 - SELECTSITE C304 DEFLECTABLE CATHETER SYSTEM, MODELS C304-S59, C304-L69, C304-XS59 & C304-XL74 K061416 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Oct 2006. https://www.510kdatabase.net/k062498/ 2006-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k062498-profyle-system-fda-510k.jpg K062498 - PROFYLE SYSTEM K062498 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Oct 2006. https://www.510kdatabase.net/k062148/ 2006-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k062148-depuy-pinnacle-altrx-acetabular-cup-fda-510k.jpg K062148 - DEPUY PINNACLE ALTRX ACETABULAR CUP LINER K062148 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Oct 2006. https://www.510kdatabase.net/k062687/ 2006-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k062687-bd-phoenix-automated-microbiology-fda-510k.jpg K062687 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEN - TICARCILLIN-CLAVULANATE (GN) 1/2 - 128/2UG/ML K062687 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Oct 2006. https://www.510kdatabase.net/k062446/ 2006-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k062446-modification-to-pinnacle-roii-hiflow-fda-510k.jpg K062446 - MODIFICATION TO PINNACLE ROII HIFLOW INTRODUCER SHEATH K062446 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Oct 2006. https://www.510kdatabase.net/k062850/ 2006-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k062850-autosuture-circular-eea-surgical-fda-510k.jpg K062850 - AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS K062850 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Oct 2006. https://www.510kdatabase.net/k062202/ 2006-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k062202-occlusion-balloon-fda-510k.jpg K062202 - OCCLUSION BALLOON K062202 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Oct 2006. https://www.510kdatabase.net/k062705/ 2006-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k062705-synergies-plus-gram-positive-miccombo-fda-510k.jpg K062705 - SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH LINEZOLID K062705 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Oct 2006. https://www.510kdatabase.net/k062832/ 2006-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k062832-vacora-14g-biopsy-probes-models-fda-510k.jpg K062832 - VACORA 14G BIOPSY PROBES, MODELS VB14116, VB14138 K062832 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 2006. https://www.510kdatabase.net/k062858/ 2006-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k062858-modification-to-glidesheath-fda-510k.jpg K062858 - MODIFICATION TO GLIDESHEATH K062858 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Oct 2006. https://www.510kdatabase.net/k061863/ 2006-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k061863-arthrex-corkscrew-suture-anchor-tak-fda-510k.jpg K061863 - ARTHREX CORKSCREW SUTURE ANCHOR, TAK, AND PUSHLOCK FAMILY K061863 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Oct 2006. https://www.510kdatabase.net/k062352/ 2006-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k062352-frs-screw-fda-510k.jpg K062352 - FRS SCREW K062352 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Oct 2006. https://www.510kdatabase.net/k062564/ 2006-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k062564-synthes-lcp-distal-femur-plates-fda-510k.jpg K062564 - SYNTHES LCP DISTAL FEMUR PLATES K062564 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Oct 2006. https://www.510kdatabase.net/k061842/ 2006-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k061842-quanta-lite-pbc-screen-iggiga-elisa-fda-510k.jpg K061842 - QUANTA LITE PBC SCREEN IGG/IGA ELISA K061842 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Oct 2006. https://www.510kdatabase.net/k063877/ 2006-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k063877-syngo-lung-cad-fda-510k.jpg K063877 - SYNGO LUNG CAD K063877 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 2006. https://www.510kdatabase.net/k062843/ 2006-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k062843-fox-sv-pta-catheter-fda-510k.jpg K062843 - FOX SV PTA CATHETER K062843 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Laboratories. Cleared Oct 2006. https://www.510kdatabase.net/k061876/ 2006-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k061876-codman-vpv-system-model-82-3192-fda-510k.jpg K061876 - CODMAN VPV SYSTEM, MODEL 82-3192 K061876 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Oct 2006. https://www.510kdatabase.net/k062301/ 2006-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k062301-depuy-lps-proximal-tibial-component-fda-510k.jpg K062301 - DEPUY LPS PROXIMAL TIBIAL COMPONENT K062301 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Oct 2006. https://www.510kdatabase.net/k062768/ 2006-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k062768-nexgen-complete-knee-solution-legacy-fda-510k.jpg K062768 - NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED FLEX FIXED BEARING AND TIVANIUM TI-6AL-4V ALLOY FEMORAL K062768 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Oct 2006. https://www.510kdatabase.net/k062773/ 2006-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k062773-microscan-microstrep-plus-panel-fda-510k.jpg K062773 - MICROSCAN MICROSTREP PLUS PANEL, PENICILLIN K062773 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Oct 2006. https://www.510kdatabase.net/k062923/ 2006-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k062923-microscan-microstrep-plus-panel-fda-510k.jpg K062923 - MICROSCAN MICROSTREP PLUS PANEL TETRACYCLINE (0.006 TO 16 MCG/ML) K062923 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Oct 2006. https://www.510kdatabase.net/k062972/ 2006-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k062972-precinorm-ck-mb-and-precipath-ck-mb-fda-510k.jpg K062972 - PRECINORM CK-MB AND PRECIPATH CK-MB CONTROLS K062972 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Oct 2006. https://www.510kdatabase.net/k062927/ 2006-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k062927-microscan-microstrep-plus-panel-fda-510k.jpg K062927 - MICROSCAN MICROSTREP PLUS PANEL AMPICILLIN (0.013 - 16 MCG/ML) K062927 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Oct 2006. https://www.510kdatabase.net/k062727/ 2006-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k062727-cardioblate-navigator-tissue-fda-510k.jpg K062727 - CARDIOBLATE NAVIGATOR TISSUE DISSECTION DEVICE K062727 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medtronic Vascular. Cleared Oct 2006. https://www.510kdatabase.net/k062777/ 2006-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k062777-microscan-microstrep-plus-panel-fda-510k.jpg K062777 - MICROSCAN MICROSTREP PLUS PANEL, CLINDAMYCIN K062777 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Oct 2006. https://www.510kdatabase.net/k052223/ 2006-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k052223-access-epo-assay-fda-510k.jpg K052223 - ACCESS EPO ASSAY K052223 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Oct 2006. https://www.510kdatabase.net/k061575/ 2006-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k061575-olympus-calcium-arsenazo-reagent-fda-510k.jpg K061575 - OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117 K061575 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus America, Inc.. Cleared Oct 2006. https://www.510kdatabase.net/k062351/ 2006-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k062351-syngo-dual-energy-fda-510k.jpg K062351 - SYNGO DUAL ENERGY K062351 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 2006. https://www.510kdatabase.net/k062516/ 2006-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k062516-access-thyroglobulin-antibody-ii-assay-fda-510k.jpg K062516 - ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS) K062516 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Oct 2006. https://www.510kdatabase.net/k062680/ 2006-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k062680-bd-phoenix-automated-microbiology-fda-510k.jpg K062680 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TICARCILLIN (GN) 1-128 UG/ML K062680 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Oct 2006. https://www.510kdatabase.net/k061616/ 2006-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k061616-coulter-lh-780-hematology-analyzer-fda-510k.jpg K061616 - COULTER LH 780 HEMATOLOGY ANALYZER K061616 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Oct 2006. https://www.510kdatabase.net/k062035/ 2006-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k062035-dimension-vista-rf-flex-reagent-fda-510k.jpg K062035 - DIMENSION VISTA RF FLEX REAGENT CARTRIDGE K062035 is a FDA 510(k) cleared immunology medical device. Manufacturer: Dade Behring, Inc.. Cleared Oct 2006. https://www.510kdatabase.net/k062113/ 2006-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k062113-solar-reunion-fracture-stem-fda-510k.jpg K062113 - SOLAR REUNION FRACTURE STEM K062113 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Oct 2006. https://www.510kdatabase.net/k061568/ 2006-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k061568-codman-eds-3-csf-external-drainage-fda-510k.jpg K061568 - CODMAN EDS 3 CSF EXTERNAL DRAINAGE SYSTEM, MODELS 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-1738 K061568 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Sep 2006. https://www.510kdatabase.net/k061942/ 2006-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k061942-tympanic-temperature-probe-with-foam-fda-510k.jpg K061942 - TYMPANIC TEMPERATURE PROBE WITH FOAM, MODEL M1024233 K061942 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ge Healthcare. Cleared Sep 2006. https://www.510kdatabase.net/k062365/ 2006-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k062365-arthrex-aspirate-kit-fda-510k.jpg K062365 - ARTHREX ASPIRATE KIT K062365 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Arthrex, Inc.. Cleared Sep 2006. https://www.510kdatabase.net/k062576/ 2006-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k062576-datex-ohmeda-s5-e-psmp-module-fda-510k.jpg K062576 - DATEX-OHMEDA S/5 E-PSM(P) MODULE (CONSISTING OF E-PSM, E-PSMP AND E-INTPSM MODULES) AND ACCESSORIES K062576 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Healthcare. Cleared Sep 2006. https://www.510kdatabase.net/k062654/ 2006-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k062654-depuy-sigma-cruciate-retaining-fda-510k.jpg K062654 - DEPUY SIGMA CRUCIATE RETAINING POROCOAT FEMORAL COMPONENTS K062654 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Sep 2006. https://www.510kdatabase.net/k062693/ 2006-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k062693-gladiator-bipolar-system-fda-510k.jpg K062693 - GLADIATOR BIPOLAR SYSTEM K062693 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Sep 2006. https://www.510kdatabase.net/k062747/ 2006-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k062747-arthrex-retrobutton-15mm-60mm-fda-510k.jpg K062747 - ARTHREX RETROBUTTON, 15MM, 60MM, RETROBUTTON, LONG, 15MM, 60MM K062747 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Sep 2006. https://www.510kdatabase.net/k061976/ 2006-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k061976-ckis-004a-injector-synchronization-fda-510k.jpg K061976 - CKIS-004A INJECTOR SYNCHRONIZATION OPTION K061976 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Sep 2006. https://www.510kdatabase.net/k062679/ 2006-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k062679-arthrex-corkscrew-ft-iii-suture-anchor-fda-510k.jpg K062679 - ARTHREX CORKSCREW FT III SUTURE ANCHOR WITH THREE #2 SUTURES K062679 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Sep 2006. https://www.510kdatabase.net/k062606/ 2006-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k062606-cd-horizon-spinal-system-fda-510k.jpg K062606 - CD HORIZON SPINAL SYSTEM K062606 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Sep 2006. https://www.510kdatabase.net/k060919/ 2006-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k060919-actical-fda-510k.jpg K060919 - ACTICAL K060919 is a FDA 510(k) cleared neurology medical device. Manufacturer: Respironics, Inc.. Cleared Sep 2006. https://www.510kdatabase.net/k061598/ 2006-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k061598-hemosil-homocysteine-and-controls-fda-510k.jpg K061598 - HEMOSIL HOMOCYSTEINE AND CONTROLS K061598 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 2006. https://www.510kdatabase.net/k061852/ 2006-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k061852-dimension-vista-c3-and-c4-flex-reagent-fda-510k.jpg K061852 - DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGH K061852 is a FDA 510(k) cleared immunology medical device. Manufacturer: Dade Behring, Inc.. Cleared Sep 2006. https://www.510kdatabase.net/k062334/ 2006-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k062334-dimension-vista-chemistry-3-calibrator-fda-510k.jpg K062334 - DIMENSION VISTA CHEMISTRY 3 CALIBRATOR, MODEL KC130 K062334 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Sep 2006. https://www.510kdatabase.net/k062618/ 2006-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k062618-trilogy-tx-with-3rd-party-couch-top-fda-510k.jpg K062618 - TRILOGY TX WITH 3RD PARTY COUCH TOP SUPPORT K062618 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Sep 2006. https://www.510kdatabase.net/k061787/ 2006-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k061787-maxforce-tts-single-use-balloon-dilator-fda-510k.jpg K061787 - MAXFORCE TTS SINGLE-USE BALLOON DILATOR K061787 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Sep 2006. https://www.510kdatabase.net/k061910/ 2006-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k061910-synthes-usa-synthes-angular-stable-fda-510k.jpg K061910 - SYNTHES (USA) [SYNTHES] ANGULAR STABLE LOCKING SYSTEM (ASLS) K061910 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Sep 2006. https://www.510kdatabase.net/k062086/ 2006-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k062086-navivision-fda-510k.jpg K062086 - NAVIVISION K062086 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Sep 2006. https://www.510kdatabase.net/k062594/ 2006-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k062594-modification-to-polarcath-peripheral-fda-510k.jpg K062594 - MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM K062594 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Sep 2006. https://www.510kdatabase.net/k061945/ 2006-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k061945-vitek-2-ast-ys-fluconazole-fda-510k.jpg K061945 - VITEK 2 AST-YS FLUCONAZOLE K061945 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Sep 2006. https://www.510kdatabase.net/k061990/ 2006-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k061990-dimension-vista-microalbumin-flex-fda-510k.jpg K061990 - DIMENSION VISTA MICROALBUMIN FLEX REAGENT CARTRIDGE K061990 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Sep 2006. https://www.510kdatabase.net/k062585/ 2006-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k062585-microscan-microstrep-plus-panel-fda-510k.jpg K062585 - MICROSCAN MICROSTREP PLUS PANEL AZITHROMYCIN K062585 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Sep 2006. https://www.510kdatabase.net/k062596/ 2006-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k062596-microstrep-plus-panel-fda-510k.jpg K062596 - MICROSTREP PLUS PANEL AMOXICILLIN/CLAVULANIC ACID K062596 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Sep 2006. https://www.510kdatabase.net/k061190/ 2006-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k061190-access-intact-pth-and-calibrators-fda-510k.jpg K061190 - ACCESS INTACT PTH AND CALIBRATORS, MODELS A 16972 AND A 16953 K061190 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Sep 2006. https://www.510kdatabase.net/k061741/ 2006-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k061741-mac-labcardiolab-combolabspecialslab-fda-510k.jpg K061741 - MAC-LAB/CARDIOLAB /COMBOLAB/SPECIALSLAB SYSTEM K061741 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Healthcare. Cleared Sep 2006. https://www.510kdatabase.net/k061877/ 2006-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k061877-wallflex-enteral-colonic-stent-with-fda-510k.jpg K061877 - WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM K061877 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Sep 2006. https://www.510kdatabase.net/k061974/ 2006-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k061974-gem-premier-4000-with-iqm-model-4000-fda-510k.jpg K061974 - GEM PREMIER 4000 WITH IQM, MODEL 4000 K061974 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 2006. https://www.510kdatabase.net/k062216/ 2006-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k062216-peri-loc-periarticular-locked-plating-fda-510k.jpg K062216 - PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM K062216 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Sep 2006. https://www.510kdatabase.net/k062406/ 2006-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k062406-aesculap-neuro-patties-fda-510k.jpg K062406 - AESCULAP NEURO PATTIES K062406 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Sep 2006. https://www.510kdatabase.net/k060762/ 2006-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k060762-aesculap-peek-vertebral-body-fda-510k.jpg K060762 - AESCULAP PEEK VERTEBRAL BODY REPLACEMENT SYSTEM K060762 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aesculap, Inc.. Cleared Sep 2006. https://www.510kdatabase.net/k062162/ 2006-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k062162-dimension-vista-system-drugs-of-abuse-fda-510k.jpg K062162 - DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510) K062162 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Dade Behring, Inc.. Cleared Sep 2006. https://www.510kdatabase.net/k062182/ 2006-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k062182-dimension-vista-system-ecstasy-fda-510k.jpg K062182 - DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520 K062182 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Dade Behring, Inc.. Cleared Sep 2006. https://www.510kdatabase.net/k062207/ 2006-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k062207-bd-phoenix-automated-microbiology-fda-510k.jpg K062207 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFUROXIME (GN) 1-64 UG/ML K062207 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Sep 2006. https://www.510kdatabase.net/k062319/ 2006-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k062319-calibrator-for-automated-systems-cfas-fda-510k.jpg K062319 - CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.), MODEL 10759350 360 K062319 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Sep 2006. https://www.510kdatabase.net/k061668/ 2006-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k061668-optecure-ccc-fda-510k.jpg K061668 - OPTECURE +CCC K061668 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Sep 2006. https://www.510kdatabase.net/k062408/ 2006-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k062408-smith-nephew-modular-femoral-hemi-head-fda-510k.jpg K062408 - SMITH & NEPHEW MODULAR FEMORAL (HEMI) HEAD K062408 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Sep 2006. https://www.510kdatabase.net/k062427/ 2006-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k062427-verte-stack-spinal-system-fda-510k.jpg K062427 - VERTE-STACK SPINAL SYSTEM K062427 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Sep 2006. https://www.510kdatabase.net/k061515/ 2006-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k061515-renalsoft-fda-510k.jpg K061515 - RENALSOFT K061515 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Sep 2006. https://www.510kdatabase.net/k061648/ 2006-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k061648-depuy-graduated-compartmental-knee-gck-fda-510k.jpg K061648 - DEPUY GRADUATED COMPARTMENTAL KNEE (GCK) K061648 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Sep 2006. https://www.510kdatabase.net/k061795/ 2006-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k061795-dimension-vista-pbnp-flex-reagent-fda-510k.jpg K061795 - DIMENSION VISTA PBNP FLEX REAGENT CARTRIDGE AND CALIBRATOR K061795 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Sep 2006. https://www.510kdatabase.net/k061802/ 2006-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k061802-dimension-vista-cardiophase-hscrp-flex-fda-510k.jpg K061802 - DIMENSION VISTA CARDIOPHASE HSCRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, HSCRP CONTROL LOW, HSCRP 1 CONTROL HIGH K061802 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Sep 2006. https://www.510kdatabase.net/k061973/ 2006-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k061973-synthes-35mm-spring-plate-fda-510k.jpg K061973 - SYNTHES 3.5MM SPRING PLATE K061973 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Sep 2006. https://www.510kdatabase.net/k062239/ 2006-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k062239-glucose-hk-new-formulation-test-system-fda-510k.jpg K062239 - GLUCOSE HK NEW FORMULATION TEST SYSTEM K062239 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Sep 2006. https://www.510kdatabase.net/k061940/ 2006-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k061940-synthes-lcp-ankle-arthrodesis-plates-fda-510k.jpg K061940 - SYNTHES LCP ANKLE ARTHRODESIS PLATES K061940 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Sep 2006. https://www.510kdatabase.net/k062206/ 2006-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k062206-bd-phoenix-automated-microbiology-fda-510k.jpg K062206 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN (STREP) 0.0625 - 8UG/ML K062206 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Sep 2006. https://www.510kdatabase.net/k062420/ 2006-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k062420-5f-sherpa-active-nx-guide-catheter-fda-510k.jpg K062420 - 5F SHERPA ACTIVE NX GUIDE CATHETER K062420 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Sep 2006. https://www.510kdatabase.net/k061825/ 2006-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k061825-dimension-vista-crp-flex-reagent-fda-510k.jpg K061825 - DIMENSION VISTA CRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBRATOR, CONTROL LOW AND CONTROL HIGH K061825 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Sep 2006. https://www.510kdatabase.net/k062034/ 2006-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k062034-dimension-vista-system-drug-1-fda-510k.jpg K062034 - DIMENSION VISTA SYSTEM DRUG 1 CALIBRATOR (DRUG 1 CAL - KC410) K062034 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Sep 2006. https://www.510kdatabase.net/k062199/ 2006-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k062199-dimension-vista-system-drug-3-fda-510k.jpg K062199 - DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430) K062199 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Dade Behring, Inc.. Cleared Sep 2006. https://www.510kdatabase.net/k062316/ 2006-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k062316-dimension-vista-ammonia-amon-flex-fda-510k.jpg K062316 - DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE K062316 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Sep 2006. https://www.510kdatabase.net/k062407/ 2006-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k062407-gateway-thoracolumbar-plate-system-fda-510k.jpg K062407 - GATEWAY THORACOLUMBAR PLATE SYSTEM K062407 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Sep 2006. https://www.510kdatabase.net/k061442/ 2006-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k061442-pulse-oximeter-model-pm-50-fda-510k.jpg K061442 - PULSE OXIMETER, MODEL PM-50 K061442 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Sep 2006. https://www.510kdatabase.net/k061635/ 2006-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k061635-msd-bipolar-forceps-fda-510k.jpg K061635 - MSD BIPOLAR FORCEPS K061635 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Sep 2006. https://www.510kdatabase.net/k061958/ 2006-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k061958-medtronic-export-xt-catheter-fda-510k.jpg K061958 - MEDTRONIC EXPORT XT CATHETER K061958 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Sep 2006. https://www.510kdatabase.net/k061231/ 2006-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k061231-wellflex-biliary-rx-stent-system-fda-510k.jpg K061231 - WELLFLEX BILIARY RX STENT SYSTEM K061231 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Sep 2006. https://www.510kdatabase.net/k062290/ 2006-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k062290-microscan-microstrep-plus-panel-fda-510k.jpg K062290 - MICROSCAN MICROSTREP PLUS PANEL VANCOMYCIN (0.06 - 8 MCG/ML) K062290 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Sep 2006. https://www.510kdatabase.net/k062326/ 2006-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k062326-autosuture-modified-versaport-trocar-fda-510k.jpg K062326 - AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVE K062326 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Sep 2006. https://www.510kdatabase.net/k062393/ 2006-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k062393-ge-vantage-pet-neuro-software-fda-510k.jpg K062393 - GE VANTAGE PET NEURO SOFTWARE K062393 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Sep 2006. https://www.510kdatabase.net/k062430/ 2006-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k062430-hemosil-protein-c-fda-510k.jpg K062430 - HEMOSIL PROTEIN C K062430 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 2006. https://www.510kdatabase.net/k062431/ 2006-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k062431-hemosil-liquid-antithrombin-fda-510k.jpg K062431 - HEMOSIL LIQUID ANTITHROMBIN K062431 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 2006. https://www.510kdatabase.net/k061870/ 2006-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k061870-vitalsense-xhr-fda-510k.jpg K061870 - VITALSENSE XHR K061870 is a FDA 510(k) cleared neurology medical device. Manufacturer: Respironics, Inc.. Cleared Aug 2006. https://www.510kdatabase.net/k061970/ 2006-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k061970-elecsys-ige-ii-immunoassay-fda-510k.jpg K061970 - ELECSYS IGE II IMMUNOASSAY K061970 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics. Cleared Aug 2006. https://www.510kdatabase.net/k062299/ 2006-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k062299-synthes-sterile-mandible-external-fda-510k.jpg K062299 - SYNTHES STERILE MANDIBLE EXTERNAL FIXATION KIT K062299 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Aug 2006. https://www.510kdatabase.net/k061839/ 2006-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k061839-dimension-vista-dbil-flex-reagent-fda-510k.jpg K061839 - DIMENSION VISTA DBIL FLEX REAGENT CARTRIDGE, MODEL K2125 K061839 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Aug 2006. https://www.510kdatabase.net/k061221/ 2006-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k061221-dupuy-s-rom-std-hip-stem-prosthesis-fda-510k.jpg K061221 - DUPUY S-ROM STD HIP STEM PROSTHESIS K061221 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Aug 2006. https://www.510kdatabase.net/k060677/ 2006-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k060677-n-latex-cdt-fda-510k.jpg K060677 - N LATEX CDT K060677 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Aug 2006. https://www.510kdatabase.net/k061719/ 2006-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k061719-dimension-vista-tbil-flex-reagent-fda-510k.jpg K061719 - DIMENSION VISTA TBIL FLEX REAGENT CARTRIDGE, AND DIMENSION VISTA TBIL/DBIL CALIBRATOR K061719 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Aug 2006. https://www.510kdatabase.net/k061923/ 2006-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k061923-dimension-vista-enzyme-1-calibrator-fda-510k.jpg K061923 - DIMENSION VISTA ENZYME 1 CALIBRATOR (ENZ 1 CAL - KC310) K061923 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Aug 2006. https://www.510kdatabase.net/k062121/ 2006-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k062121-dimension-vista-system-drug-2-fda-510k.jpg K062121 - DIMENSION VISTA SYSTEM DRUG 2 CALIBRATOR (DRUG 2 CAL - KC420) K062121 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Aug 2006. https://www.510kdatabase.net/k062122/ 2006-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k062122-dimension-vista-system-chemistry-3-fda-510k.jpg K062122 - DIMENSION VISTA SYSTEM CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL - KC130) K062122 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Aug 2006. https://www.510kdatabase.net/k061845/ 2006-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k061845-dimension-vista-igm-flex-reagent-fda-510k.jpg K061845 - DIMENSION VISTA IGM FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H K061845 is a FDA 510(k) cleared immunology medical device. Manufacturer: Dade Behring, Inc.. Cleared Aug 2006. https://www.510kdatabase.net/k062293/ 2006-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k062293-microscan-microstrep-plus-panel-fda-510k.jpg K062293 - MICROSCAN MICROSTREP PLUS PANEL CHLORAMPHENICOL (1 TO 32 MCG/ML) K062293 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Aug 2006. https://www.510kdatabase.net/k060773/ 2006-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k060773-online-tdm-procainamide-fda-510k.jpg K060773 - ONLINE TDM PROCAINAMIDE K060773 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Aug 2006. https://www.510kdatabase.net/k061872/ 2006-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k061872-microscan-microstrep-plus-panel-fda-510k.jpg K061872 - MICROSCAN MICROSTREP PLUS PANEL K061872 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Aug 2006. https://www.510kdatabase.net/k062173/ 2006-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k062173-modification-to-bone-graft-syringe-fda-510k.jpg K062173 - MODIFICATION TO BONE GRAFT SYRINGE K062173 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Aug 2006. https://www.510kdatabase.net/k062179/ 2006-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k062179-microscan-dried-gram-positive-miccombo-fda-510k.jpg K062179 - MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN (0.25 - 16UG/ML) K062179 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Aug 2006. https://www.510kdatabase.net/k062276/ 2006-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k062276-microscan-microstrep-plus-panel-fda-510k.jpg K062276 - MICROSCAN MICROSTREP PLUS PANEL K062276 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Aug 2006. https://www.510kdatabase.net/k061434/ 2006-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k061434-trident-large-diameter-hip-system-fda-510k.jpg K061434 - TRIDENT LARGE DIAMETER HIP SYSTEM K061434 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Aug 2006. https://www.510kdatabase.net/k062134/ 2006-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k062134-vigileo-arterial-pressure-cardiac-fda-510k.jpg K062134 - VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR K062134 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Aug 2006. https://www.510kdatabase.net/k060727/ 2006-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k060727-vectorvision-hip-fda-510k.jpg K060727 - VECTORVISION HIP K060727 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Aug 2006. https://www.510kdatabase.net/k061838/ 2006-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k061838-dimension-vista-chemistry-1-calibrator-fda-510k.jpg K061838 - DIMENSION VISTA CHEMISTRY 1 CALIBRATOR, MODEL KC110 K061838 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Aug 2006. https://www.510kdatabase.net/k062128/ 2006-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k062128-the-dimension-vista-flex-reagent-fda-510k.jpg K062128 - THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS K062128 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Aug 2006. https://www.510kdatabase.net/k062191/ 2006-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k062191-dimension-vista-system-drugs-of-abuse-fda-510k.jpg K062191 - DIMENSION VISTA SYSTEM DRUGS OF ABUSE POSITIVE AND NEGATIVE CONTROLS, MODELS KC515 AND KC516 K062191 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Dade Behring, Inc.. Cleared Aug 2006. https://www.510kdatabase.net/k062236/ 2006-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k062236-dimension-vista-cyclosporine-csa-flex-fda-510k.jpg K062236 - DIMENSION VISTA CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE K062236 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Aug 2006. https://www.510kdatabase.net/k061223/ 2006-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k061223-advance-total-knee-system-fda-510k.jpg K061223 - ADVANCE TOTAL KNEE SYSTEM K061223 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Aug 2006. https://www.510kdatabase.net/k061699/ 2006-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k061699-excia-fda-510k.jpg K061699 - EXCIA K061699 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aesculap, Inc.. Cleared Aug 2006. https://www.510kdatabase.net/k061869/ 2006-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k061869-bd-phoenix-automated-microbiology-fda-510k.jpg K061869 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN-TAZOBACTAM (GP) 1/4-128/4 UG/ML K061869 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Aug 2006. https://www.510kdatabase.net/k061918/ 2006-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k061918-foley-catheters-with-temperature-probe-fda-510k.jpg K061918 - FOLEY CATHETERS WITH TEMPERATURE PROBE K061918 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ge Healthcare. Cleared Aug 2006. https://www.510kdatabase.net/k062116/ 2006-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k062116-delta-cta-reverse-shoulder-system-fda-510k.jpg K062116 - DELTA CTA REVERSE SHOULDER SYSTEM HUMERAL HEADS K062116 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Aug 2006. https://www.510kdatabase.net/k061980/ 2006-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k061980-siemens-acuson-x500-ultrasound-system-fda-510k.jpg K061980 - SIEMENS ACUSON X500 ULTRASOUND SYSTEM K061980 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 2006. https://www.510kdatabase.net/k060738/ 2006-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k060738-tdm-n-acetylprocainamide-fda-510k.jpg K060738 - TDM N-ACETYLPROCAINAMIDE K060738 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Aug 2006. https://www.510kdatabase.net/k062041/ 2006-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k062041-model-3875-1-x-8-sc-test-stimulation-fda-510k.jpg K062041 - MODEL 3875 1 X 8 SC TEST STIMULATION LEAD K062041 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic, Inc.. Cleared Aug 2006. https://www.510kdatabase.net/k062152/ 2006-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k062152-creatinine-kinase-mb-isoenzyme-fda-510k.jpg K062152 - CREATININE KINASE MB ISOENZYME VERIFIER, MODEL DC27 K062152 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Aug 2006. https://www.510kdatabase.net/k062066/ 2006-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k062066-omega-3-system-fda-510k.jpg K062066 - OMEGA 3 SYSTEM K062066 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Aug 2006. https://www.510kdatabase.net/k061885/ 2006-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k061885-dimension-vista-system-total-fda-510k.jpg K061885 - DIMENSION VISTA SYSTEM TOTAL TRIIODOTHYRONINE CALIBRATOR, MODEL KC250 K061885 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Aug 2006. https://www.510kdatabase.net/k062073/ 2006-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k062073-verte-stack-spinal-system-fda-510k.jpg K062073 - VERTE-STACK SPINAL SYSTEM K062073 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Aug 2006. https://www.510kdatabase.net/k060620/ 2006-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k060620-accu-chek-aviva-test-strips-fda-510k.jpg K060620 - ACCU-CHEK AVIVA TEST STRIPS K060620 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Aug 2006. https://www.510kdatabase.net/k060978/ 2006-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k060978-coaguchek-xs-system-fda-510k.jpg K060978 - COAGUCHEK XS SYSTEM K060978 is a FDA 510(k) cleared hematology medical device. Manufacturer: Roche Diagnostics. Cleared Aug 2006. https://www.510kdatabase.net/k061332/ 2006-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k061332-filterwire-ez-embolic-protection-fda-510k.jpg K061332 - FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (2.25 MM-3.5 MM) K061332 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Aug 2006. https://www.510kdatabase.net/k061521/ 2006-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k061521-triathlon-metal-backed-patella-fda-510k.jpg K061521 - TRIATHLON METAL BACKED PATELLA K061521 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Aug 2006. https://www.510kdatabase.net/k061579/ 2006-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k061579-modification-to-cd-horizon-spinal-system-fda-510k.jpg K061579 - MODIFICATION TO CD HORIZON SPINAL SYSTEM K061579 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Aug 2006. https://www.510kdatabase.net/k061750/ 2006-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k061750-dimension-vista-system-lipid-fda-510k.jpg K061750 - DIMENSION VISTA SYSTEM LIPID CALIBRATOR, MODEL KC220 K061750 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Aug 2006. https://www.510kdatabase.net/k061994/ 2006-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k061994-web-viewer-pocket-viewer-and-cellular-fda-510k.jpg K061994 - WEB VIEWER, POCKET VIEWER AND CELLULAR VIEWER WITH L- WEB05 SOFTWARE K061994 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Healthcare. Cleared Aug 2006. https://www.510kdatabase.net/k053287/ 2006-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k053287-cobas-amplicor-ctng-test-for-chlamydia-fda-510k.jpg K053287 - COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS K053287 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Aug 2006. https://www.510kdatabase.net/k053289/ 2006-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k053289-cobas-amplicor-ctng-test-for-neisseria-fda-510k.jpg K053289 - COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE K053289 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Aug 2006. https://www.510kdatabase.net/k061783/ 2006-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k061783-knee-fusion-nail-fda-510k.jpg K061783 - KNEE FUSION NAIL K061783 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Aug 2006. https://www.510kdatabase.net/k061867/ 2006-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k061867-bd-phoenix-automated-microbiology-fda-510k.jpg K061867 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFAZOLIN (GN) 0.5-32 UG/ML K061867 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Aug 2006. https://www.510kdatabase.net/k061179/ 2006-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k061179-powerhickman-long-term-intravascular-fda-510k.jpg K061179 - POWERHICKMAN LONG-TERM INTRAVASCULAR CATHETER K061179 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Aug 2006. https://www.510kdatabase.net/k060690/ 2006-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k060690-online-valproic-acid-fda-510k.jpg K060690 - ONLINE VALPROIC ACID K060690 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Aug 2006. https://www.510kdatabase.net/k061727/ 2006-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k061727-gore-preclude-vessel-guard-fda-510k.jpg K061727 - GORE PRECLUDE VESSEL GUARD K061727 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Aug 2006. https://www.510kdatabase.net/k061793/ 2006-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k061793-dimension-vista-iron-flex-reagent-fda-510k.jpg K061793 - DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR K061793 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Aug 2006. https://www.510kdatabase.net/k062055/ 2006-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k062055-dimension-vista-protein-1-calibrator-fda-510k.jpg K062055 - DIMENSION VISTA PROTEIN 1 CALIBRATOR, CONTROL LOW, CONTROL MEDIUM, CONTROL HIGH K062055 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Aug 2006. https://www.510kdatabase.net/k053348/ 2006-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k053348-stryker-orthopaedics-rfid-fda-510k.jpg K053348 - STRYKER ORTHOPAEDICS RFID INSTRUMENTATION K053348 is a FDA 510(k) cleared neurology medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Aug 2006. https://www.510kdatabase.net/k060307/ 2006-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k060307-12-rl-algorithm-fda-510k.jpg K060307 - 12 RL ALGORITHM K060307 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Aug 2006. https://www.510kdatabase.net/k061753/ 2006-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k061753-synthes-usa-clavicle-hook-plates-fda-510k.jpg K061753 - SYNTHES (USA) CLAVICLE HOOK PLATES K061753 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Aug 2006. https://www.510kdatabase.net/k061779/ 2006-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k061779-competitor-unicondylar-all-poly-tibial-fda-510k.jpg K061779 - COMPETITOR UNICONDYLAR ALL-POLY TIBIAL BASEPLATE K061779 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Aug 2006. https://www.510kdatabase.net/k062037/ 2006-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k062037-triathlon-low-profile-tibial-tray-fda-510k.jpg K062037 - TRIATHLON LOW PROFILE TIBIAL TRAY K062037 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Aug 2006. https://www.510kdatabase.net/k061226/ 2006-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k061226-trabecular-metal-acetabular-revision-fda-510k.jpg K061226 - TRABECULAR METAL ACETABULAR REVISION SYSTEM CAGE K061226 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Aug 2006. https://www.510kdatabase.net/k061256/ 2006-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k061256-smartmonitor-2ps-fda-510k.jpg K061256 - SMARTMONITOR 2PS K061256 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Aug 2006. https://www.510kdatabase.net/k061344/ 2006-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k061344-excia-total-hip-system-lateral-offset-fda-510k.jpg K061344 - EXCIA TOTAL HIP SYSTEM LATERAL OFFSET K061344 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aesculap, Inc.. Cleared Aug 2006. https://www.510kdatabase.net/k061703/ 2006-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k061703-dimension-vista-chemistry-2-calibrator-fda-510k.jpg K061703 - DIMENSION VISTA CHEMISTRY 2 CALIBRATOR (CHEM 2 CAL, KC120) K061703 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Aug 2006. https://www.510kdatabase.net/k062057/ 2006-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k062057-u-clip-device-model-nc65-fda-510k.jpg K062057 - U-CLIP DEVICE, MODEL NC65 K062057 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medtronic Vascular. Cleared Aug 2006. https://www.510kdatabase.net/k060833/ 2006-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k060833-12sl-ecg-analysis-program-fda-510k.jpg K060833 - 12SL ECG ANALYSIS PROGRAM K060833 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Aug 2006. https://www.510kdatabase.net/k061882/ 2006-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k061882-oxygenless-packaging-conversion-of-fda-510k.jpg K061882 - OXYGENLESS PACKAGING CONVERSION OF LEGACY CENTERPULSE STANDARD POLYETHYLENE DEVICES K061882 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Aug 2006. https://www.510kdatabase.net/k060556/ 2006-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k060556-brigit-surgical-device-fda-510k.jpg K060556 - BRIGIT SURGICAL DEVICE K060556 is a FDA 510(k) cleared neurology medical device. Manufacturer: Zimmer, Inc.. Cleared Jul 2006. https://www.510kdatabase.net/k061424/ 2006-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k061424-celsite-celsite-concept-access-ports-fda-510k.jpg K061424 - CELSITE/ CELSITE CONCEPT, ACCESS PORTS K061424 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Aesculap, Inc.. Cleared Jul 2006. https://www.510kdatabase.net/k061673/ 2006-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k061673-bd-phoenix-automated-microbiology-fda-510k.jpg K061673 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMOXICILLIN-CLAVULANATE(GP) 0.25/0.12 -32/16 UG/ML K061673 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Jul 2006. https://www.510kdatabase.net/k062024/ 2006-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k062024-dimension-vista-digitoxin-digoxin-fda-510k.jpg K062024 - DIMENSION VISTA DIGITOXIN, DIGOXIN, GENTAMICIN, N-ACETYLPROCAINAMIDE, PHENYTOIN, THEOPHYLLINE FLEX REAGENT CARTRIDGE K062024 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Dade Behring, Inc.. Cleared Jul 2006. https://www.510kdatabase.net/k061180/ 2006-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k061180-ksea-rotocut-g1-electromechanical-fda-510k.jpg K061180 - KSEA ROTOCUT G1 ELECTROMECHANICAL MORCELLATOR K061180 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jul 2006. https://www.510kdatabase.net/k061621/ 2006-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k061621-synthes-usa-65-mm-cancellous-screws-fda-510k.jpg K061621 - SYNTHES (USA) 6.5 MM CANCELLOUS SCREWS K061621 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jul 2006. https://www.510kdatabase.net/k061582/ 2006-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k061582-varisource-200-hdr-afterloader-fda-510k.jpg K061582 - VARISOURCE 200 HDR AFTERLOADER K061582 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Jul 2006. https://www.510kdatabase.net/k061665/ 2006-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k061665-arthrex-45-mm-55-mm-and-65-mm-fda-510k.jpg K061665 - ARTHREX 4.5 MM, 5.5 MM AND 6.5 MM CORKSCREW FT K061665 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jul 2006. https://www.510kdatabase.net/k061915/ 2006-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k061915-cd-horizon-spinal-system-fda-510k.jpg K061915 - CD HORIZON SPINAL SYSTEM K061915 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Jul 2006. https://www.510kdatabase.net/k061786/ 2006-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k061786-versys-fiber-metal-midcoat-low-head-fda-510k.jpg K061786 - VERSYS FIBER METAL MIDCOAT LOW HEAD CENTER HIP PROSTHESIS K061786 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jul 2006. https://www.510kdatabase.net/k060489/ 2006-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k060489-dade-pfa-100-platelet-function-fda-510k.jpg K060489 - DADE PFA-100 PLATELET FUNCTION ANALYZER AND REAGENTS K060489 is a FDA 510(k) cleared hematology medical device. Manufacturer: Dade Behring, Inc.. Cleared Jul 2006. https://www.510kdatabase.net/k061574/ 2006-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k061574-coulter-lh-750-hematology-analyzer-fda-510k.jpg K061574 - COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632 K061574 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jul 2006. https://www.510kdatabase.net/k061683/ 2006-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k061683-tina-quant-myoglobin-gen2-test-system-fda-510k.jpg K061683 - TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM K061683 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jul 2006. https://www.510kdatabase.net/k061687/ 2006-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k061687-microscan-dried-gram-negative-miccombo-fda-510k.jpg K061687 - MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS K061687 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Jul 2006. https://www.510kdatabase.net/k061946/ 2006-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k061946-acuson-x300-diagnostic-ultrasound-system-fda-510k.jpg K061946 - ACUSON X300 DIAGNOSTIC ULTRASOUND SYSTEM K061946 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 2006. https://www.510kdatabase.net/k061202/ 2006-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k061202-revere-stabilization-system-fda-510k.jpg K061202 - REVERE STABILIZATION SYSTEM K061202 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Jul 2006. https://www.510kdatabase.net/k061275/ 2006-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k061275-medline-syringes-multiple-fda-510k.jpg K061275 - MEDLINE SYRINGES, MULTIPLE K061275 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Jul 2006. https://www.510kdatabase.net/k061704/ 2006-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k061704-optilene-mesh-fda-510k.jpg K061704 - OPTILENE MESH K061704 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Jul 2006. https://www.510kdatabase.net/k061168/ 2006-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k061168-pca-36mm-femoral-heads-fda-510k.jpg K061168 - PCA 36MM FEMORAL HEADS K061168 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jul 2006. https://www.510kdatabase.net/k061304/ 2006-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k061304-cd-horizon-spinal-system-fda-510k.jpg K061304 - CD HORIZON SPINAL SYSTEM K061304 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Jul 2006. https://www.510kdatabase.net/k061536/ 2006-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k061536-microscan-dried-gram-negative-miccombo-fda-510k.jpg K061536 - MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS K061536 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Jul 2006. https://www.510kdatabase.net/k061792/ 2006-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k061792-dimension-vista-ethyl-alcohol-alc-fda-510k.jpg K061792 - DIMENSION VISTA ETHYL ALCOHOL (ALC), ALKALINE PHOSPHATASE (ALP), CALCIUM (CA0 FLEX, LACTIC ACID (LA) FLEX REAGENT CARTRI K061792 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Dade Behring, Inc.. Cleared Jul 2006. https://www.510kdatabase.net/k061818/ 2006-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k061818-dimension-vista-system-alkaline-fda-510k.jpg K061818 - DIMENSION VISTA SYSTEM ALKALINE PHOSPHATASE CALIBRATOR (ALP CAL - KC330) K061818 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Jul 2006. https://www.510kdatabase.net/k061939/ 2006-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k061939-modification-to-allomatrix-custom-fda-510k.jpg K061939 - MODIFICATION TO ALLOMATRIX CUSTOM K061939 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jul 2006. https://www.510kdatabase.net/k061243/ 2006-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k061243-smith-nephew-modular-femoral-head-fda-510k.jpg K061243 - SMITH & NEPHEW MODULAR FEMORAL HEAD K061243 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 2006. https://www.510kdatabase.net/k061833/ 2006-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k061833-depuy-aml-hip-prosthesis-fda-510k.jpg K061833 - DEPUY AML HIP PROSTHESIS K061833 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jul 2006. https://www.510kdatabase.net/k060812/ 2006-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k060812-powerporttmimplanted-titanium-port-w8-fda-510k.jpg K060812 - POWERPORT(TM)IMPLANTED TITANIUM PORT W/8 FR. CHRONOFLEX CATHETER-MULTIPLE K060812 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jul 2006. https://www.510kdatabase.net/k061037/ 2006-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k061037-pds-plus-antibacterial-suture-fda-510k.jpg K061037 - PDS PLUS ANTIBACTERIAL SUTURE K061037 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Jul 2006. https://www.510kdatabase.net/k061050/ 2006-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k061050-gynecare-morcellex-tissue-morcellator-fda-510k.jpg K061050 - GYNECARE MORCELLEX TISSUE MORCELLATOR, MODELS MX0100 AND MX0100R K061050 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ethicon, Inc.. Cleared Jul 2006. https://www.510kdatabase.net/k061066/ 2006-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k061066-synergy-hip-system-fda-510k.jpg K061066 - SYNERGY HIP SYSTEM K061066 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 2006. https://www.510kdatabase.net/k061751/ 2006-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k061751-dimension-vista-system-ucfp-calibrator-fda-510k.jpg K061751 - DIMENSION VISTA SYSTEM UCFP CALIBRATOR, MODEL KC260 K061751 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Jul 2006. https://www.510kdatabase.net/k053246/ 2006-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k053246-patient-matched-hip-stem-fda-510k.jpg K053246 - PATIENT MATCHED HIP STEM K053246 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 2006. https://www.510kdatabase.net/k053584/ 2006-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k053584-iplan-rt-dose-fda-510k.jpg K053584 - IPLAN RT DOSE K053584 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab AG. Cleared Jul 2006. https://www.510kdatabase.net/k061682/ 2006-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k061682-ge-voluson-e8-ultrasound-system-fda-510k.jpg K061682 - GE VOLUSON E8 ULTRASOUND SYSTEM K061682 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jul 2006. https://www.510kdatabase.net/k061011/ 2006-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k061011-competitor-unicondylar-knee-tibial-fda-510k.jpg K061011 - COMPETITOR UNICONDYLAR KNEE TIBIAL BASEPLATE K061011 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 2006. https://www.510kdatabase.net/k061655/ 2006-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k061655-dimension-vista-flex-reagent-cartridges-fda-510k.jpg K061655 - DIMENSION VISTA FLEX REAGENT CARTRIDGES K061655 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Jul 2006. https://www.510kdatabase.net/k061667/ 2006-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k061667-cell-dyn-ruby-system-fda-510k.jpg K061667 - CELL-DYN RUBY SYSTEM K061667 is a FDA 510(k) cleared hematology medical device. Manufacturer: Abbott Laboratories. Cleared Jul 2006. https://www.510kdatabase.net/k061677/ 2006-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k061677-solar-purefix-ha-shoulder-fda-510k.jpg K061677 - SOLAR PUREFIX HA SHOULDER K061677 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jul 2006. https://www.510kdatabase.net/k061702/ 2006-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k061702-dimension-vista-system-creatine-kinase-fda-510k.jpg K061702 - DIMENSION VISTA SYSTEM CREATINE KINASE CALIBRATOR (CK CAL - KC340) K061702 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Jul 2006. https://www.510kdatabase.net/k061654/ 2006-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k061654-trident-constrained-acetabular-insert-fda-510k.jpg K061654 - TRIDENT CONSTRAINED ACETABULAR INSERT K061654 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jul 2006. https://www.510kdatabase.net/k061069/ 2006-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k061069-spife-ife-15-pentavalent-model-3456-fda-510k.jpg K061069 - SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL 3457, SPIFT IFE-6 PENTAVALENT KIT, MODEL 3458 K061069 is a FDA 510(k) cleared immunology medical device. Manufacturer: Helena Laboratories. Cleared Jul 2006. https://www.510kdatabase.net/k061338/ 2006-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k061338-dimension-vista-iga-flex-reagent-fda-510k.jpg K061338 - DIMENSION VISTA IGA FLEX REAGENT CARTRIDGE ASSAY K061338 is a FDA 510(k) cleared immunology medical device. Manufacturer: Dade Behring, Inc.. Cleared Jul 2006. https://www.510kdatabase.net/k061382/ 2006-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k061382-access-tpo-antibody-and-access-tpo-fda-510k.jpg K061382 - ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS A12985 AND A18227 K061382 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jul 2006. https://www.510kdatabase.net/k061569/ 2006-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k061569-smith-nephew-competitor-deuce-femoral-fda-510k.jpg K061569 - SMITH & NEPHEW COMPETITOR DEUCE FEMORAL COMPONENTS K061569 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 2006. https://www.510kdatabase.net/k061390/ 2006-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k061390-dimension-vista-system-enzyme2-fda-510k.jpg K061390 - DIMENSION VISTA SYSTEM ENZYME2 CALIBRATOR, MODEL KC320 K061390 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Jul 2006. https://www.510kdatabase.net/k061093/ 2006-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k061093-cholinesterase-gen2-test-system-fda-510k.jpg K061093 - CHOLINESTERASE GEN.2 TEST SYSTEM K061093 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jul 2006. https://www.510kdatabase.net/k061327/ 2006-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k061327-bd-phoenix-automated-microbiology-fda-510k.jpg K061327 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMOXICILLIN-CLAVULANATE (GN) 0.5/0.25-32/16 UG/ML, AMPICILLIN-SULBACTAM (GN) 0. K061327 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Jul 2006. https://www.510kdatabase.net/k061525/ 2006-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k061525-ge-vivid-i-fda-510k.jpg K061525 - GE VIVID - I K061525 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jul 2006. https://www.510kdatabase.net/k061547/ 2006-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k061547-dynasty-acetabular-shell-fda-510k.jpg K061547 - DYNASTY ACETABULAR SHELL K061547 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jul 2006. https://www.510kdatabase.net/k061218/ 2006-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k061218-dimension-vista-system-chemistry-fda-510k.jpg K061218 - DIMENSION VISTA SYSTEM CHEMISTRY CALIBRATOR 4, MODEL KC140 K061218 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Jun 2006. https://www.510kdatabase.net/k060666/ 2006-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k060666-carotid-access-kit-fda-510k.jpg K060666 - CAROTID ACCESS KIT K060666 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Jun 2006. https://www.510kdatabase.net/k060874/ 2006-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k060874-depuy-global-ap-shoulder-system-fda-510k.jpg K060874 - DEPUY GLOBAL AP SHOULDER SYSTEM K060874 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jun 2006. https://www.510kdatabase.net/k061261/ 2006-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k061261-l4-oxygen-concentrator-fda-510k.jpg K061261 - L4 OXYGEN CONCENTRATOR K061261 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Jun 2006. https://www.510kdatabase.net/k061427/ 2006-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k061427-pre-impression-conditioning-solution-fda-510k.jpg K061427 - PRE-IMPRESSION CONDITIONING SOLUTION K061427 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jun 2006. https://www.510kdatabase.net/k061625/ 2006-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k061625-autobone2-fda-510k.jpg K061625 - AUTOBONE2 K061625 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Jun 2006. https://www.510kdatabase.net/k060281/ 2006-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k060281-vs-800-vital-signs-monitor-fda-510k.jpg K060281 - VS-800 VITAL SIGNS MONITOR K060281 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Jun 2006. https://www.510kdatabase.net/k061034/ 2006-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k061034-bipap-plus-m-series-bi-level-system-fda-510k.jpg K061034 - BIPAP PLUS M-SERIES BI-LEVEL SYSTEM K061034 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Jun 2006. https://www.510kdatabase.net/k061587/ 2006-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k061587-fullcard-analysis-fda-510k.jpg K061587 - FULLCARD ANALYSIS K061587 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Jun 2006. https://www.510kdatabase.net/k061503/ 2006-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k061503-dimension-cyclosporine-extended-range-fda-510k.jpg K061503 - DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A) K061503 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Dade Behring, Inc.. Cleared Jun 2006. https://www.510kdatabase.net/k061605/ 2006-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k061605-nemio-xg-saa-580a-fda-510k.jpg K061605 - NEMIO XG, SAA-580A K061605 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Jun 2006. https://www.510kdatabase.net/k061347/ 2006-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k061347-vitek-2-gram-positive-vrsa-screen-fda-510k.jpg K061347 - VITEK 2 GRAM POSITIVE VRSA SCREEN K061347 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jun 2006. https://www.510kdatabase.net/k053409/ 2006-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k053409-3m-liquid-bandage-fda-510k.jpg K053409 - 3M LIQUID BANDAGE K053409 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3M Company. Cleared Jun 2006. https://www.510kdatabase.net/k060456/ 2006-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k060456-medline-collagen-wound-dressing-fda-510k.jpg K060456 - MEDLINE COLLAGEN WOUND DRESSING K060456 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medline Industries, Inc.. Cleared Jun 2006. https://www.510kdatabase.net/k060630/ 2006-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k060630-reflection-3-hole-shell-with-fda-510k.jpg K060630 - REFLECTION 3-HOLE SHELL WITH ASYMMETRIC POROUS COATING K060630 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jun 2006. https://www.510kdatabase.net/k060875/ 2006-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k060875-abbott-axsym-troponin-i-adv-fda-510k.jpg K060875 - ABBOTT AXSYM TROPONIN-I ADV K060875 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jun 2006. https://www.510kdatabase.net/k061454/ 2006-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k061454-exactech-equinoxe-shoulder-stems-fda-510k.jpg K061454 - EXACTECH EQUINOXE SHOULDER STEMS K061454 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Jun 2006. https://www.510kdatabase.net/k060853/ 2006-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k060853-online-tdm-tobramycin-fda-510k.jpg K060853 - ONLINE TDM TOBRAMYCIN K060853 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jun 2006. https://www.510kdatabase.net/k061144/ 2006-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k061144-depuy-cmw-2-and-cmw-3-gentamicin-bone-fda-510k.jpg K061144 - DEPUY CMW 2 AND CMW 3 GENTAMICIN BONE CEMENT K061144 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jun 2006. https://www.510kdatabase.net/k061154/ 2006-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k061154-kinsa-suture-anchor-fda-510k.jpg K061154 - KINSA SUTURE ANCHOR K061154 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jun 2006. https://www.510kdatabase.net/k061352/ 2006-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k061352-peri-loc-periarticular-locked-plating-fda-510k.jpg K061352 - PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM FOR THE UPPER EXTREMITY K061352 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jun 2006. https://www.510kdatabase.net/k061380/ 2006-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k061380-retain-radiolucent-spacer-fda-510k.jpg K061380 - RETAIN RADIOLUCENT SPACER K061380 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Jun 2006. https://www.510kdatabase.net/k061097/ 2006-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k061097-coherence-dosimetrist-model-22-fda-510k.jpg K061097 - COHERENCE DOSIMETRIST, MODEL 2.2 K061097 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 2006. https://www.510kdatabase.net/k061355/ 2006-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k061355-bd-phoenix-automated-microbiology-fda-510k.jpg K061355 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMPICILLIN (GN) 0.5-32 UG/ML K061355 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Jun 2006. https://www.510kdatabase.net/k053159/ 2006-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k053159-vectorvision-spine-fda-510k.jpg K053159 - VECTORVISION SPINE K053159 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Jun 2006. https://www.510kdatabase.net/k060201/ 2006-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k060201-olympus-rf-latex-calibrator-and-fda-510k.jpg K060201 - OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105. K060201 is a FDA 510(k) cleared immunology medical device. Manufacturer: Olympus America, Inc.. Cleared Jun 2006. https://www.510kdatabase.net/k061019/ 2006-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k061019-trigen-meta-nail-retrograde-femoral-fda-510k.jpg K061019 - TRIGEN META-NAIL RETROGRADE FEMORAL AND TIBIAL NAILS K061019 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jun 2006. https://www.510kdatabase.net/k061312/ 2006-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k061312-36mm-biolox-delta-ceramic-heads-fda-510k.jpg K061312 - 36MM BIOLOX DELTA CERAMIC HEADS K061312 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jun 2006. https://www.510kdatabase.net/k060937/ 2006-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k060937-brilliance-volume-fda-510k.jpg K060937 - BRILLIANCE VOLUME K060937 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Jun 2006. https://www.510kdatabase.net/k061235/ 2006-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k061235-lifestent-turbo-biliary-stent-system-fda-510k.jpg K061235 - LIFESTENT TURBO BILIARY STENT SYSTEM K061235 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Jun 2006. https://www.510kdatabase.net/k060138/ 2006-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k060138-synthes-usa-craniomaxillofacial-fda-510k.jpg K060138 - SYNTHES (USA) CRANIOMAXILLOFACIAL DISTRACTION SYSTEM K060138 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Jun 2006. https://www.510kdatabase.net/k060641/ 2006-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k060641-platelia-aspergillus-eia-model-62793-fda-510k.jpg K060641 - PLATELIA ASPERGILLUS EIA, MODEL 62793 K060641 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bio-Rad. Cleared Jun 2006. https://www.510kdatabase.net/k061249/ 2006-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k061249-axsym-digoxin-iii-fda-510k.jpg K061249 - AXSYM DIGOXIN III K061249 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Jun 2006. https://www.510kdatabase.net/k061282/ 2006-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k061282-access-ultrasensitive-hgh-calibrator-fda-510k.jpg K061282 - ACCESS ULTRASENSITIVE HGH CALIBRATOR, MODEL 33585 K061282 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jun 2006. https://www.510kdatabase.net/k061129/ 2006-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k061129-ge-logiq-9-models-2188900-2375600-fda-510k.jpg K061129 - GE LOGIQ 9, MODELS 2188900, 2375600, 2404587 AND 5150000 K061129 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jun 2006. https://www.510kdatabase.net/k061189/ 2006-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k061189-dp-9900-digital-ultrasonic-diagnostic-fda-510k.jpg K061189 - DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM K061189 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Jun 2006. https://www.510kdatabase.net/k060707/ 2006-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k060707-aesculap-bipolar-acetabular-cup-fda-510k.jpg K060707 - AESCULAP BIPOLAR ACETABULAR CUP K060707 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aesculap, Inc.. Cleared May 2006. https://www.510kdatabase.net/k061095/ 2006-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k061095-auto-sutur-endo-gia-staplers-fda-510k.jpg K061095 - AUTO SUTUR ENDO GIA STAPLERS K061095 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared May 2006. https://www.510kdatabase.net/k061251/ 2006-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k061251-dimension-vista-total-iron-binding-fda-510k.jpg K061251 - DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATOR K061251 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared May 2006. https://www.510kdatabase.net/k061253/ 2006-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k061253-reflection-3-acetabular-system-fda-510k.jpg K061253 - REFLECTION 3 ACETABULAR SYSTEM K061253 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared May 2006. https://www.510kdatabase.net/k060645/ 2006-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k060645-preciset-dat-plus-i-preciset-dat-plus-fda-510k.jpg K060645 - PRECISET DAT PLUS I, PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS K060645 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared May 2006. https://www.510kdatabase.net/k061370/ 2006-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k061370-cardiq-fusion-fda-510k.jpg K061370 - CARDIQ FUSION K061370 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared May 2006. https://www.510kdatabase.net/k060722/ 2006-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k060722-nexgen-complete-knee-solution-fda-510k.jpg K060722 - NEXGEN COMPLETE KNEE SOLUTION ULTRACONGRUENT (UC-FLEX) FIXED BEARING ARTICULAR SURFACE COMPONENT K060722 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared May 2006. https://www.510kdatabase.net/k060918/ 2006-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k060918-excia-total-hip-system-1214-trunnion-fda-510k.jpg K060918 - EXCIA TOTAL HIP SYSTEM 12/14 TRUNNION WITH CERAMIC HEAD K060918 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aesculap, Inc.. Cleared May 2006. https://www.510kdatabase.net/k060324/ 2006-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k060324-bd-phoenix-automated-microbiology-fda-510k.jpg K060324 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM FOR USE WITH THE ANTIMICROBIAL AGENT GATIFLOXACIN 0.25-8 UG/ML - GRAM-NEGATIVE K060324 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared May 2006. https://www.510kdatabase.net/k060713/ 2006-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k060713-proceed-surgical-mesh-fda-510k.jpg K060713 - PROCEED SURGICAL MESH K060713 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared May 2006. https://www.510kdatabase.net/k060746/ 2006-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k060746-memory-staple-fda-510k.jpg K060746 - MEMORY STAPLE K060746 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared May 2006. https://www.510kdatabase.net/k061238/ 2006-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k061238-dimension-vista-carbon-dioxide-fda-510k.jpg K061238 - DIMENSION VISTA CARBON DIOXIDE, CREATININE AND LACTATE DEHYDROGENASE FLEX REAGENT CARTRIDGE K061238 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared May 2006. https://www.510kdatabase.net/k061274/ 2006-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k061274-venture-anterior-cervical-plate-system-fda-510k.jpg K061274 - VENTURE ANTERIOR CERVICAL PLATE SYSTEM K061274 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared May 2006. https://www.510kdatabase.net/k052511/ 2006-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k052511-cardiofax-ce-model-ecg-1500-a-fda-510k.jpg K052511 - CARDIOFAX CE, MODEL ECG-1500 A K052511 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared May 2006. https://www.510kdatabase.net/k061127/ 2006-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k061127-cg-future-annuloplasty-system-model-638r-fda-510k.jpg K061127 - CG FUTURE ANNULOPLASTY SYSTEM, MODEL 638R K061127 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared May 2006. https://www.510kdatabase.net/k060994/ 2006-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k060994-mondial-fda-510k.jpg K060994 - MONDIAL K060994 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared May 2006. https://www.510kdatabase.net/k053337/ 2006-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k053337-dimension-urine-ecstasy-screen-flex-fda-510k.jpg K053337 - DIMENSION URINE ECSTASY SCREEN FLEX REAGENT CARTRIDGE, MODEL DF 109 K053337 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared May 2006. https://www.510kdatabase.net/k060478/ 2006-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k060478-arthrex-bio-compression-screw-fda-510k.jpg K060478 - ARTHREX BIO-COMPRESSION SCREW K060478 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared May 2006. https://www.510kdatabase.net/k060581/ 2006-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k060581-depuy-solution-system-hip-prosthesis-fda-510k.jpg K060581 - DEPUY SOLUTION SYSTEM HIP PROSTHESIS K060581 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared May 2006. https://www.510kdatabase.net/k060704/ 2006-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k060704-zimmer-trabecular-metal-reverse-fda-510k.jpg K060704 - ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, SIZES 8MM AND 10MM K060704 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared May 2006. https://www.510kdatabase.net/k061012/ 2006-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k061012-axsos-plus-locking-plate-system-fda-510k.jpg K061012 - AXSOS PLUS LOCKING PLATE SYSTEM K061012 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared May 2006. https://www.510kdatabase.net/k053193/ 2006-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k053193-pm-8000-express-patient-monitor-model-fda-510k.jpg K053193 - PM-8000 EXPRESS PATIENT MONITOR, MODEL PM-8000 EXPRESS K053193 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared May 2006. https://www.510kdatabase.net/k060502/ 2006-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k060502-dimension-tacr-flex-reagent-cartridge-fda-510k.jpg K060502 - DIMENSION TACR FLEX REAGENT CARTRIDGE, MODEL DF107 K060502 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Dade Behring, Inc.. Cleared May 2006. https://www.510kdatabase.net/k060503/ 2006-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k060503-dimension-tacr-calibrator-model-dc107-fda-510k.jpg K060503 - DIMENSION TACR CALIBRATOR, MODEL DC107 K060503 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Dade Behring, Inc.. Cleared May 2006. https://www.510kdatabase.net/k061260/ 2006-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k061260-intuitive-surgical-endowrist-pk-fda-510k.jpg K061260 - INTUITIVE SURGICAL ENDOWRIST PK DISSECTING FORCEPS, MODELS 400214 & 420214 K061260 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared May 2006. https://www.510kdatabase.net/k053579/ 2006-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k053579-columbus-ultra-congruent-uc-tibial-fda-510k.jpg K053579 - COLUMBUS ULTRA CONGRUENT (UC) TIBIAL INSERT/GLIDING SURFACE K053579 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aesculap, Inc.. Cleared May 2006. https://www.510kdatabase.net/k061048/ 2006-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k061048-cobas-integra-glucose-hk-gen-3-test-fda-510k.jpg K061048 - COBAS INTEGRA GLUCOSE HK GEN. 3 TEST SYSTEM K061048 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared May 2006. https://www.510kdatabase.net/k061064/ 2006-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k061064-coulter-lin-c-linearity-control-models-fda-510k.jpg K061064 - COULTER LIN-C LINEARITY CONTROL, MODELS 7547065, 723503 K061064 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared May 2006. https://www.510kdatabase.net/k061185/ 2006-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k061185-datex-ohmeda-s5-compact-anesthesia-fda-510k.jpg K061185 - DATEX-OHMEDA S/5 COMPACT ANESTHESIA MONITOR WITH L-CANE05A AND L-CANE05A SOFTWARE K061185 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Healthcare. Cleared May 2006. https://www.510kdatabase.net/k060040/ 2006-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k060040-zimmer-ml-taper-hip-prosthesis-fda-510k.jpg K060040 - ZIMMER M/L TAPER HIP PROSTHESIS K060040 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared May 2006. https://www.510kdatabase.net/k060323/ 2006-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k060323-ultraflex-precision-colonic-stent-fda-510k.jpg K060323 - ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380 K060323 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corporation. Cleared May 2006. https://www.510kdatabase.net/k060969/ 2006-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k060969-polyax-locked-plating-system-fda-510k.jpg K060969 - POLYAX LOCKED PLATING SYSTEM K060969 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared May 2006. https://www.510kdatabase.net/k061187/ 2006-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k061187-tsx-201a-aquilion-lb-ct-scanner-with-fda-510k.jpg K061187 - TSX-201A, AQUILION LB CT SCANNER WITH RESPIRATORY GATING K061187 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared May 2006. https://www.510kdatabase.net/k060558/ 2006-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k060558-bd-phoenix-automated-microbiology-fda-510k.jpg K060558 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEPHALOTHIN - GN 1 - 64 UG/ML K060558 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared May 2006. https://www.510kdatabase.net/k060586/ 2006-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k060586-enzyme-immunoassay-vancomycin-fda-510k.jpg K060586 - ENZYME IMMUNOASSAY, VANCOMYCIN K060586 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared May 2006. https://www.510kdatabase.net/k060358/ 2006-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k060358-profemur-tl-hip-stem-fda-510k.jpg K060358 - PROFEMUR TL HIP STEM K060358 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared May 2006. https://www.510kdatabase.net/k060665/ 2006-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k060665-xpand-radiolucent-corpectomy-spacer-fda-510k.jpg K060665 - XPAND RADIOLUCENT CORPECTOMY SPACER K060665 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared May 2006. https://www.510kdatabase.net/k061014/ 2006-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k061014-actalyke-qc-kit-models-aqc-hp-and-aqc-lp-fda-510k.jpg K061014 - ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP K061014 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared May 2006. https://www.510kdatabase.net/k061020/ 2006-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k061020-dimension-vista-albumin-alkaline-fda-510k.jpg K061020 - DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASE K061020 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared May 2006. https://www.510kdatabase.net/k061054/ 2006-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k061054-axiom-aristos-fx-plus-fda-510k.jpg K061054 - AXIOM ARISTOS FX PLUS K061054 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 2006. https://www.510kdatabase.net/k060383/ 2006-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k060383-glucose-fda-510k.jpg K060383 - GLUCOSE K060383 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared May 2006. https://www.510kdatabase.net/k060758/ 2006-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k060758-or-head-coil-15-t-fda-510k.jpg K060758 - OR HEAD COIL 1.5 T K060758 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 2006. https://www.510kdatabase.net/k053234/ 2006-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k053234-pm-9000-express-patient-monitor-fda-510k.jpg K053234 - PM-9000 EXPRESS PATIENT MONITOR K053234 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared May 2006. https://www.510kdatabase.net/k060295/ 2006-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k060295-carbon-dioxide-fda-510k.jpg K060295 - CARBON DIOXIDE K060295 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared May 2006. https://www.510kdatabase.net/k060369/ 2006-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k060369-stratus-cs-acute-care-cardiophase-fda-510k.jpg K060369 - STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TEST PAK, CALPAK, DILPAK K060369 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared May 2006. https://www.510kdatabase.net/k060949/ 2006-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k060949-dp-6600-digital-ultrasonic-diagnostic-fda-510k.jpg K060949 - DP-6600 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM K060949 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared May 2006. https://www.510kdatabase.net/k060574/ 2006-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k060574-total-bilirubin-fda-510k.jpg K060574 - TOTAL BILIRUBIN K060574 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared May 2006. https://www.510kdatabase.net/k060585/ 2006-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k060585-roche-elecsys-acthacth-calsetacth-fda-510k.jpg K060585 - ROCHE ELECSYS- ACTH,ACTH CALSET,ACTH CALCHECK,PRECICONTROL ACTH K060585 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared May 2006. https://www.510kdatabase.net/k060742/ 2006-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k060742-legion-cobalt-chrome-revision-knee-fda-510k.jpg K060742 - LEGION COBALT CHROME REVISION KNEE SYSTEM K060742 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared May 2006. https://www.510kdatabase.net/k060993/ 2006-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k060993-ge-logiq-p5-and-a5-fda-510k.jpg K060993 - GE LOGIQ P5 AND A5 K060993 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared May 2006. https://www.510kdatabase.net/k060931/ 2006-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k060931-hemosil-pt-fibrinogen-hs-plus-fda-510k.jpg K060931 - HEMOSIL PT-FIBRINOGEN HS PLUS K060931 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared May 2006. https://www.510kdatabase.net/k060633/ 2006-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k060633-coherence-oncologist-workspace-model-fda-510k.jpg K060633 - COHERENCE ONCOLOGIST WORKSPACE, MODEL 2.0 AND PHYSICIST WORKSPACE, MODEL 1.0 K060633 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 2006. https://www.510kdatabase.net/k060093/ 2006-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k060093-presep-oligon-oximetry-catheters-fda-510k.jpg K060093 - PRESEP OLIGON OXIMETRY CATHETERS K060093 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Apr 2006. https://www.510kdatabase.net/k060370/ 2006-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k060370-nexgen-knee-gender-solutions-female-fda-510k.jpg K060370 - NEXGEN KNEE GENDER SOLUTIONS FEMALE (GSF) FEMORAL COMPONENTS K060370 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Apr 2006. https://www.510kdatabase.net/k060935/ 2006-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k060935-synchron-systems-creatinine-crea-reagent-fda-510k.jpg K060935 - SYNCHRON SYSTEMS CREATININE (CREA) REAGENT K060935 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Apr 2006. https://www.510kdatabase.net/k060877/ 2006-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k060877-palmaz-blue-014-transhepatic-biliary-fda-510k.jpg K060877 - PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAX K060877 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Apr 2006. https://www.510kdatabase.net/k053612/ 2006-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k053612-dri-stat-acid-phosphatase-reagent-fda-510k.jpg K053612 - DRI-STAT ACID PHOSPHATASE REAGENT K053612 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Apr 2006. https://www.510kdatabase.net/k060447/ 2006-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k060447-bd-phoenix-automated-microbiology-fda-510k.jpg K060447 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -NITROFURANTOIN (GN) 8-512 UG/ML, TRIMETHOPRIM-SULFAMETHOXAZOLE (GN) K060447 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Apr 2006. https://www.510kdatabase.net/k060710/ 2006-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k060710-universal-locking-system-35mm-plates-fda-510k.jpg K060710 - UNIVERSAL LOCKING SYSTEM, 3.5MM PLATES AND SCREWS-4936 PLATES,4835 SCREWS K060710 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Apr 2006. https://www.510kdatabase.net/k060660/ 2006-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k060660-ew200-system-oxygen-saturation-fda-510k.jpg K060660 - EW200 SYSTEM (OXYGEN SATURATION MONITORING SYSTEM) AND PRESEP OXIMETRY CATHETER K060660 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Apr 2006. https://www.510kdatabase.net/k060613/ 2006-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k060613-variax-locking-plate-system-fda-510k.jpg K060613 - VARIAX LOCKING PLATE SYSTEM K060613 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Apr 2006. https://www.510kdatabase.net/k060774/ 2006-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k060774-folate-on-the-access-immunoassay-fda-510k.jpg K060774 - FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208 K060774 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Apr 2006. https://www.510kdatabase.net/k053356/ 2006-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k053356-modification-to-cic-pro-clinical-fda-510k.jpg K053356 - MODIFICATION TO: CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION K053356 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Apr 2006. https://www.510kdatabase.net/k060636/ 2006-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k060636-palladium-103-seed-implant-kits-multiple-fda-510k.jpg K060636 - PALLADIUM-103 SEED IMPLANT KITS -MULTIPLE K060636 is a FDA 510(k) cleared radiology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 2006. https://www.510kdatabase.net/k060731/ 2006-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k060731-evolve-modular-radial-head-fda-510k.jpg K060731 - EVOLVE MODULAR RADIAL HEAD K060731 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Apr 2006. https://www.510kdatabase.net/k060879/ 2006-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k060879-model-ec9-4-transducer-fda-510k.jpg K060879 - MODEL EC9-4 TRANSDUCER K060879 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 2006. https://www.510kdatabase.net/k060947/ 2006-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k060947-sonicath-ultra-imaging-catheter-fda-510k.jpg K060947 - SONICATH ULTRA IMAGING CATHETER, 3.2F,20MHZ MODELS 37410/456221/C1020 K060947 is a FDA 510(k) cleared radiology medical device. Manufacturer: Boston Scientific Corp. Cleared Apr 2006. https://www.510kdatabase.net/k060356/ 2006-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k060356-conserve-plus-quadrafix-acetabular-shell-fda-510k.jpg K060356 - CONSERVE PLUS QUADRAFIX ACETABULAR SHELL K060356 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Apr 2006. https://www.510kdatabase.net/k060736/ 2006-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k060736-smith-nephew-65mm-and-80mm-cannulated-fda-510k.jpg K060736 - SMITH & NEPHEW 6.5MM AND 8.0MM CANNULATED SCREWS K060736 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Apr 2006. https://www.510kdatabase.net/k060754/ 2006-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k060754-elecsys-tsh-calset-wmodels-04738551-fda-510k.jpg K060754 - ELECSYS TSH CALSET W/MODELS 04738551 K060754 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Apr 2006. https://www.510kdatabase.net/k053577/ 2006-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k053577-dimension-vista-ctni-flex-flex-reagent-fda-510k.jpg K053577 - DIMENSION VISTA CTNI FLEX FLEX REAGENT CARTRIDGE, CALIBRATOR AND SDIL SAMPLE DILUENT K053577 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Apr 2006. https://www.510kdatabase.net/k060257/ 2006-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k060257-bd-phoenix-automated-microbiology-fda-510k.jpg K060257 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOXITIN - 0.5-64 UG/ML K060257 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Apr 2006. https://www.510kdatabase.net/k060341/ 2006-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k060341-sherlock-tip-location-system-tls-fda-510k.jpg K060341 - SHERLOCK TIP LOCATION SYSTEM (TLS) K060341 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 2006. https://www.510kdatabase.net/k060696/ 2006-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k060696-acclaim-total-elbow-system-fda-510k.jpg K060696 - ACCLAIM TOTAL ELBOW SYSTEM K060696 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Apr 2006. https://www.510kdatabase.net/k060719/ 2006-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k060719-modification-to-verte-stack-spinal-fda-510k.jpg K060719 - MODIFICATION TO VERTE-STACK SPINAL SYSTEM K060719 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Apr 2006. https://www.510kdatabase.net/k060443/ 2006-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k060443-norian-crs-fast-set-putty-fda-510k.jpg K060443 - NORIAN CRS FAST SET PUTTY K060443 is a FDA 510(k) cleared neurology medical device. Manufacturer: Synthes (Usa). Cleared Apr 2006. https://www.510kdatabase.net/k060445/ 2006-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k060445-norian-crs-bone-cement-fda-510k.jpg K060445 - NORIAN CRS BONE CEMENT K060445 is a FDA 510(k) cleared neurology medical device. Manufacturer: Synthes (Usa). Cleared Apr 2006. https://www.510kdatabase.net/k060688/ 2006-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k060688-hemosil-synthasil-fda-510k.jpg K060688 - HEMOSIL SYNTHASIL K060688 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Apr 2006. https://www.510kdatabase.net/k060777/ 2006-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k060777-smith-nephew-model-660hd-image-fda-510k.jpg K060777 - SMITH & NEPHEW MODEL 660HD IMAGE MANAGEMENT SYSTEM K060777 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Apr 2006. https://www.510kdatabase.net/k060921/ 2006-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k060921-s2-recon-nail-system-fda-510k.jpg K060921 - S2 RECON NAIL SYSTEM K060921 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Apr 2006. https://www.510kdatabase.net/k060217/ 2006-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k060217-bd-phoenix-automated-microbiology-fda-510k.jpg K060217 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN-0.125-8 AND CIPROFLOXACIN-0.25 - 4 UG/ML K060217 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Apr 2006. https://www.510kdatabase.net/k060444/ 2006-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k060444-bd-phoenix-automated-microbiology-fda-510k.jpg K060444 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFEPIME (GN) , CEFTRIAXONE (GN), CEFOTAXIME (GN), 0.5-64 UG/ML K060444 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Apr 2006. https://www.510kdatabase.net/k060798/ 2006-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k060798-stryker-plating-system-fda-510k.jpg K060798 - STRYKER PLATING SYSTEM K060798 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Apr 2006. https://www.510kdatabase.net/k060959/ 2006-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k060959-symmetry-balloon-dilatation-catheter-fda-510k.jpg K060959 - SYMMETRY BALLOON DILATATION CATHETER K060959 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Apr 2006. https://www.510kdatabase.net/k060960/ 2006-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k060960-boston-scientific-talon-balloon-fda-510k.jpg K060960 - BOSTON SCIENTIFIC TALON BALLOON DILATATION CATHETER K060960 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Apr 2006. https://www.510kdatabase.net/k051984/ 2006-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k051984-filterwire-ez-225-mm-35-mm-embolic-fda-510k.jpg K051984 - FILTERWIRE EZ (2.25 MM - 3.5 MM) EMBOLIC PROTECTION SYSTEM, MODELS 20120-190, 20120-300 K051984 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Apr 2006. https://www.510kdatabase.net/k052322/ 2006-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k052322-bard-collamend-implant-models-1175101-fda-510k.jpg K052322 - BARD COLLAMEND IMPLANT, MODELS 1175101, 1175102, 1175103, 1175104, 1175105 K052322 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 2006. https://www.510kdatabase.net/k060391/ 2006-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k060391-intuitive-surgical-endowrist-fda-510k.jpg K060391 - INTUITIVE SURGICAL ENDOWRIST STABILIZER, MODEL 420182 K060391 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Apr 2006. https://www.510kdatabase.net/k060755/ 2006-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k060755-elecsys-vitamin-b12-immunoassay-calset-fda-510k.jpg K060755 - ELECSYS VITAMIN B12 IMMUNOASSAY, CALSET II AND CALCHECK K060755 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Apr 2006. https://www.510kdatabase.net/k060492/ 2006-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k060492-aesculap-craniofacial-plate-and-screw-fda-510k.jpg K060492 - AESCULAP CRANIOFACIAL PLATE AND SCREW K060492 is a FDA 510(k) cleared dental medical device. Manufacturer: Aesculap, Inc.. Cleared Apr 2006. https://www.510kdatabase.net/k060661/ 2006-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k060661-mactrode-3-fda-510k.jpg K060661 - MACTRODE 3 K060661 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Apr 2006. https://www.510kdatabase.net/k060385/ 2006-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k060385-emit-2000-tacrolimus-assay-and-sample-fda-510k.jpg K060385 - EMIT 2000 TACROLIMUS ASSAY AND SAMPLE PRETREATMENT REAGENT K060385 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Apr 2006. https://www.510kdatabase.net/k060548/ 2006-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k060548-stratus-cs-acute-care-betahcg-and-nt-fda-510k.jpg K060548 - STRATUS CS ACUTE CARE BETAHCG AND NT-PROBNP TESTPAK AND TESTPAK ASSAY, CALPAK AND DILPAK K060548 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Apr 2006. https://www.510kdatabase.net/k060628/ 2006-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k060628-dimension-tbi-flex-and-dbi-flex-fda-510k.jpg K060628 - DIMENSION TBI FLEX AND DBI FLEX REAGENT CARTRIDGES AND TBI/DBI CALIBRATOR K060628 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Apr 2006. https://www.510kdatabase.net/k053121/ 2006-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k053121-tram-module-fda-510k.jpg K053121 - TRAM MODULE K053121 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Healthcare. Cleared Apr 2006. https://www.510kdatabase.net/k060779/ 2006-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k060779-advance-vessel-analysis-ii-fda-510k.jpg K060779 - ADVANCE VESSEL ANALYSIS II K060779 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Apr 2006. https://www.510kdatabase.net/k053543/ 2006-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k053543-arthrex-arthoeresis-implant-fda-510k.jpg K053543 - ARTHREX ARTHOERESIS IMPLANT K053543 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Apr 2006. https://www.510kdatabase.net/k053569/ 2006-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k053569-agility-lp-total-ankle-prosthesis-fda-510k.jpg K053569 - AGILITY LP TOTAL ANKLE PROSTHESIS K053569 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Mar 2006. https://www.510kdatabase.net/k060542/ 2006-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k060542-ge-vivid-7-model-fc008xx-ge-vivid-7-fda-510k.jpg K060542 - GE VIVID 7 MODEL FC008XX, GE VIVID 7 MODEL FC009XX K060542 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Mar 2006. https://www.510kdatabase.net/k060550/ 2006-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k060550-kodak-directview-dr-3000-system-fda-510k.jpg K060550 - KODAK DIRECTVIEW DR 3000 SYSTEM 64KW/80KW GENERATORS, MODELS 6551345, 6551386 K060550 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Mar 2006. https://www.510kdatabase.net/k052693/ 2006-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k052693-pm-50-pulse-oximeter-fda-510k.jpg K052693 - PM-50 PULSE OXIMETER K052693 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Mar 2006. https://www.510kdatabase.net/k052788/ 2006-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k052788-n-latex-hcy-n-protein-standard-sl-nt-fda-510k.jpg K052788 - N LATEX HCY, N PROTEIN STANDARD SL, N/T PROTEIN CONTROL L/M/H K052788 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Mar 2006. https://www.510kdatabase.net/k060074/ 2006-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k060074-interlink-system-t-connector-extension-fda-510k.jpg K060074 - INTERLINK SYSTEM-T-CONNECTOR EXTENSION SET, MODEL 2N3326 K060074 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 2006. https://www.510kdatabase.net/k060493/ 2006-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k060493-bd-phoenix-automated-microbiology-fda-510k.jpg K060493 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN-GP DETECTION OF VRSA. K060493 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Mar 2006. https://www.510kdatabase.net/k053072/ 2006-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k053072-n-antisera-to-human-alpha1-antitrypsin-fda-510k.jpg K053072 - N ANTISERA TO HUMAN ALPHA1-ANTITRYPSIN K053072 is a FDA 510(k) cleared immunology medical device. Manufacturer: Dade Behring, Inc.. Cleared Mar 2006. https://www.510kdatabase.net/k053073/ 2006-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k053073-n-antisera-to-human-alpha2-macroglobulin-fda-510k.jpg K053073 - N ANTISERA TO HUMAN ALPHA2-MACROGLOBULIN K053073 is a FDA 510(k) cleared immunology medical device. Manufacturer: Dade Behring, Inc.. Cleared Mar 2006. https://www.510kdatabase.net/k060464/ 2006-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k060464-coulter-5c-cell-control-fda-510k.jpg K060464 - COULTER 5C CELL CONTROL K060464 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Mar 2006. https://www.510kdatabase.net/k060528/ 2006-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k060528-aesculap-trelon-nonabsorbable-fda-510k.jpg K060528 - AESCULAP TRELON NONABSORBABLE MULTIFILAMENT POLYAMIDE SURGICAL SUTURE K060528 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Mar 2006. https://www.510kdatabase.net/k060175/ 2006-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k060175-isight-imaging-catheter-model-38986-fda-510k.jpg K060175 - ISIGHT IMAGING CATHETER, MODEL 38986 K060175 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Mar 2006. https://www.510kdatabase.net/k053164/ 2006-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k053164-iplan-flow-fda-510k.jpg K053164 - IPLAN FLOW K053164 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Mar 2006. https://www.510kdatabase.net/k060007/ 2006-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k060007-bd-autoshield-pen-needle-fda-510k.jpg K060007 - BD AUTOSHIELD PEN NEEDLE K060007 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson & CO. Cleared Mar 2006. https://www.510kdatabase.net/k060312/ 2006-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k060312-microscan-synergies-plus-gram-positive-fda-510k.jpg K060312 - MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH VANCOMYCIN (0.25-64 UG/ML) K060312 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Mar 2006. https://www.510kdatabase.net/k060487/ 2006-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k060487-lifestent-flexstar-xl-biliary-stent-fda-510k.jpg K060487 - LIFESTENT FLEXSTAR XL BILIARY STENT SYSTEM K060487 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Mar 2006. https://www.510kdatabase.net/k060515/ 2006-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k060515-depuy-pfc-sigma-knee-prosthesis-fda-510k.jpg K060515 - DEPUY PFC SIGMA KNEE PROSTHESIS K060515 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Mar 2006. https://www.510kdatabase.net/k052999/ 2006-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k052999-semperflo-infusion-system-fda-510k.jpg K052999 - SEMPERFLO INFUSION SYSTEM K052999 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ethicon, Inc.. Cleared Mar 2006. https://www.510kdatabase.net/k060437/ 2006-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k060437-excia-total-hip-system-with-u-cap-fda-510k.jpg K060437 - EXCIA TOTAL HIP SYSTEM WITH U-CAP K060437 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aesculap, Inc.. Cleared Mar 2006. https://www.510kdatabase.net/k060408/ 2006-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k060408-norian-srs-bone-void-filler-fda-510k.jpg K060408 - NORIAN SRS BONE VOID FILLER K060408 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Mar 2006. https://www.510kdatabase.net/k060406/ 2006-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k060406-norian-srs-fast-set-putty-fda-510k.jpg K060406 - NORIAN SRS FAST SET PUTTY K060406 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Mar 2006. https://www.510kdatabase.net/k060468/ 2006-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k060468-vectorvision-hip-fda-510k.jpg K060468 - VECTORVISION HIP K060468 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Mar 2006. https://www.510kdatabase.net/k060218/ 2006-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k060218-bd-phoenix-automated-microbiology-fda-510k.jpg K060218 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN-0.0625-8 UG/ML, AND QUINUPRISTIN/DALFOPRISTIN-0.25-4 UG/ML K060218 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Mar 2006. https://www.510kdatabase.net/k060514/ 2006-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k060514-stryker-plating-system-fda-510k.jpg K060514 - STRYKER PLATING SYSTEM K060514 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Mar 2006. https://www.510kdatabase.net/k060631/ 2006-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k060631-biograph-64-and-biograph-40-fda-510k.jpg K060631 - BIOGRAPH 64 AND BIOGRAPH 40 K060631 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2006. https://www.510kdatabase.net/k053074/ 2006-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k053074-n-antisera-to-human-ceruloplasmin-fda-510k.jpg K053074 - N ANTISERA TO HUMAN CERULOPLASMIN K053074 is a FDA 510(k) cleared immunology medical device. Manufacturer: Dade Behring, Inc.. Cleared Mar 2006. https://www.510kdatabase.net/k053075/ 2006-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k053075-n-antisera-to-human-transferrin-fda-510k.jpg K053075 - N ANTISERA TO HUMAN TRANSFERRIN K053075 is a FDA 510(k) cleared immunology medical device. Manufacturer: Dade Behring, Inc.. Cleared Mar 2006. https://www.510kdatabase.net/k060137/ 2006-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k060137-kodak-eclipse-image-processing-software-fda-510k.jpg K060137 - KODAK ECLIPSE IMAGE PROCESSING SOFTWARE K060137 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Mar 2006. https://www.510kdatabase.net/k060226/ 2006-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k060226-oncor-expression-fda-510k.jpg K060226 - ONCOR EXPRESSION K060226 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2006. https://www.510kdatabase.net/k060360/ 2006-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k060360-howmedica-osteonics-modular-rotating-fda-510k.jpg K060360 - HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE WITH OFFSET ADAPTERS K060360 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Mar 2006. https://www.510kdatabase.net/k060418/ 2006-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k060418-8f-sherpa-nx-guide-catheter-fda-510k.jpg K060418 - 8F SHERPA NX GUIDE CATHETER K060418 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Mar 2006. https://www.510kdatabase.net/k060429/ 2006-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k060429-tdm-control-set-fda-510k.jpg K060429 - TDM CONTROL SET K060429 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Mar 2006. https://www.510kdatabase.net/k060572/ 2006-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k060572-modification-to-polarcath-peripheral-fda-510k.jpg K060572 - MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM K060572 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Mar 2006. https://www.510kdatabase.net/k060373/ 2006-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k060373-cobas-6000-series-system-fda-510k.jpg K060373 - COBAS 6000 SERIES SYSTEM K060373 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics. Cleared Mar 2006. https://www.510kdatabase.net/k060419/ 2006-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k060419-concerto-bipolar-needle-electrode-fda-510k.jpg K060419 - CONCERTO BIPOLAR NEEDLE ELECTRODE K060419 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Boston Scientific Corp. Cleared Mar 2006. https://www.510kdatabase.net/k052839/ 2006-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k052839-ct-perfusion-4-fda-510k.jpg K052839 - CT PERFUSION 4 K052839 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Mar 2006. https://www.510kdatabase.net/k060214/ 2006-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k060214-bd-phoenix-automated-mircrobiology-fda-510k.jpg K060214 - BD PHOENIX AUTOMATED MIRCROBIOLOGY SYSTEM TETRACYCLINE-GN 0.5-16 UG/ML AND GP 0.5-16 UG/ML K060214 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Mar 2006. https://www.510kdatabase.net/k060266/ 2006-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k060266-dimension-iron-calibrator-fda-510k.jpg K060266 - DIMENSION IRON CALIBRATOR K060266 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Mar 2006. https://www.510kdatabase.net/k060371/ 2006-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k060371-the-emit-2000-tacrolimus-calibrators-fda-510k.jpg K060371 - THE EMIT 2000 TACROLIMUS CALIBRATORS K060371 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Mar 2006. https://www.510kdatabase.net/k060264/ 2006-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k060264-dimension-iron-flex-reagent-cartridge-fda-510k.jpg K060264 - DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85) K060264 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Mar 2006. https://www.510kdatabase.net/k052202/ 2006-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k052202-axiom-artis-modular-angiographic-system-fda-510k.jpg K052202 - AXIOM ARTIS - MODULAR ANGIOGRAPHIC SYSTEM K052202 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2006. https://www.510kdatabase.net/k052953/ 2006-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k052953-nuvance-facial-rejuvenation-system-fda-510k.jpg K052953 - NUVANCE* FACIAL REJUVENATION SYSTEM K052953 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Mar 2006. https://www.510kdatabase.net/k053319/ 2006-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k053319-allomatrix-custom-fda-510k.jpg K053319 - ALLOMATRIX CUSTOM K053319 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Mar 2006. https://www.510kdatabase.net/k060224/ 2006-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k060224-modification-to-mira-flex-18-fda-510k.jpg K060224 - MODIFICATION TO MIRA-FLEX 18 MICROCATHETER K060224 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook Incorporated. Cleared Mar 2006. https://www.510kdatabase.net/k053531/ 2006-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k053531-dimension-vista-free-thyroxine-flex-fda-510k.jpg K053531 - DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE AND LOCI 1 CALIBRATOR K053531 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Mar 2006. https://www.510kdatabase.net/k053609/ 2006-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k053609-presep-and-pediasat-oximetry-catheters-fda-510k.jpg K053609 - PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR K053609 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Feb 2006. https://www.510kdatabase.net/k060400/ 2006-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k060400-cardioblate-surgical-ablation-fda-510k.jpg K060400 - CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 68000 K060400 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medtronic, Inc.. Cleared Feb 2006. https://www.510kdatabase.net/k060011/ 2006-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k060011-miig-sr-fda-510k.jpg K060011 - MIIG SR K060011 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Feb 2006. https://www.510kdatabase.net/k060090/ 2006-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k060090-dimension-vista-thyroid-stimulating-fda-510k.jpg K060090 - DIMENSION VISTA THYROID STIMULATING HORMONE FLEX REAGENT CARTRIDGE K060090 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Feb 2006. https://www.510kdatabase.net/k060256/ 2006-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k060256-unicel-dxc-600i-synchron-access-fda-510k.jpg K060256 - UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM K060256 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Feb 2006. https://www.510kdatabase.net/k053504/ 2006-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k053504-microscan-synergies-plus-gram-positive-fda-510k.jpg K053504 - MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN (0.12-16 UG/ML) K053504 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Feb 2006. https://www.510kdatabase.net/k053344/ 2006-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k053344-bioraptor-suture-anchor-twinfix-28-mm-fda-510k.jpg K053344 - BIORAPTOR SUTURE ANCHOR, TWINFIX 2.8 MM SUTURE ANCHOR, TWINFIX 3.5 MM SUTURE ANCHOR K053344 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Feb 2006. https://www.510kdatabase.net/k060162/ 2006-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k060162-acl-elite-fda-510k.jpg K060162 - ACL ELITE K060162 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Feb 2006. https://www.510kdatabase.net/k060174/ 2006-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k060174-spectrum-five-lumen-central-venous-fda-510k.jpg K060174 - SPECTRUM FIVE LUMEN CENTRAL VENOUS CATHETER SET, MODEL C-UQLM10.0-ABRM K060174 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cook, Inc.. Cleared Feb 2006. https://www.510kdatabase.net/k052168/ 2006-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k052168-medline-silvertouch-100-silicone-foley-fda-510k.jpg K052168 - MEDLINE SILVERTOUCH 100% SILICONE FOLEY CATHETER, MODEL MEDLINE INDUSTRIES, INC. K052168 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medline Industries, Inc.. Cleared Feb 2006. https://www.510kdatabase.net/k053108/ 2006-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k053108-dimension-csae-cyclosporine-extended-fda-510k.jpg K053108 - DIMENSION CSAE CYCLOSPORINE EXTENDED RANGE CALIBRATOR, MODEL DC108 K053108 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Feb 2006. https://www.510kdatabase.net/k053512/ 2006-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k053512-homechoicehomechoice-pro-personal-fda-510k.jpg K053512 - HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C4471 AND 5C8310 K053512 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Feb 2006. https://www.510kdatabase.net/k060108/ 2006-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k060108-cobas-integra-chloride-elctrode-gen2-fda-510k.jpg K060108 - COBAS INTEGRA CHLORIDE ELCTRODE GEN.2 K060108 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Feb 2006. https://www.510kdatabase.net/k052321/ 2006-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k052321-versys-epoch-fullcoat-hip-prosthesis-fda-510k.jpg K052321 - VERSYS EPOCH FULLCOAT HIP PROSTHESIS K052321 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Feb 2006. https://www.510kdatabase.net/k052833/ 2006-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k052833-gore-tex-non-sterile-surgical-gowns-fda-510k.jpg K052833 - GORE-TEX NON-STERILE SURGICAL GOWNS K052833 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Feb 2006. https://www.510kdatabase.net/k053352/ 2006-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k053352-comfortlite-nasal-mask-fda-510k.jpg K053352 - COMFORTLITE NASAL MASK K053352 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Feb 2006. https://www.510kdatabase.net/k053389/ 2006-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k053389-aesculap-sterilcontainer-system-fda-510k.jpg K053389 - AESCULAP STERILCONTAINER SYSTEM K053389 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Aesculap, Inc.. Cleared Feb 2006. https://www.510kdatabase.net/k060123/ 2006-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k060123-levelert-ii-fluid-level-sensor-fda-510k.jpg K060123 - LEVELERT II FLUID LEVEL SENSOR K060123 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Feb 2006. https://www.510kdatabase.net/k052966/ 2006-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k052966-ci-knee-ci-mi-tkr-fda-510k.jpg K052966 - CI KNEE, CI MI TKR K052966 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Feb 2006. https://www.510kdatabase.net/k060081/ 2006-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k060081-basis-spinal-system-fda-510k.jpg K060081 - BASIS SPINAL SYSTEM K060081 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Feb 2006. https://www.510kdatabase.net/k060130/ 2006-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k060130-immage-systems-low-concentration-fda-510k.jpg K060130 - IMMAGE SYSTEMS LOW CONCENTRATION IMMUNOGLOBULIN A REAGENT K060130 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Feb 2006. https://www.510kdatabase.net/k060203/ 2006-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k060203-modification-to-cd-horizon-spinal-system-fda-510k.jpg K060203 - MODIFICATION TO CD HORIZON SPINAL SYSTEM K060203 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Feb 2006. https://www.510kdatabase.net/k060095/ 2006-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k060095-modification-to-vaclok-syringe-fda-510k.jpg K060095 - MODIFICATION TO: VACLOK SYRINGE K060095 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Feb 2006. https://www.510kdatabase.net/k053127/ 2006-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k053127-iplan-fda-510k.jpg K053127 - IPLAN K053127 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Feb 2006. https://www.510kdatabase.net/k053603/ 2006-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k053603-c-reactive-protein-latex-high-fda-510k.jpg K053603 - C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR COBAS INTEGRA INSTRUMENTS K053603 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Feb 2006. https://www.510kdatabase.net/k050806/ 2006-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k050806-optecure-fda-510k.jpg K050806 - OPTECURE K050806 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Feb 2006. https://www.510kdatabase.net/k060079/ 2006-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k060079-kodak-model-cr-7400-digital-fda-510k.jpg K060079 - KODAK MODEL CR-7400 DIGITAL RADIOGRAPHY SYSTEM K060079 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Feb 2006. https://www.510kdatabase.net/k053426/ 2006-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k053426-roche-elecsys-anti-tg-fda-510k.jpg K053426 - ROCHE ELECSYS ANTI-TG K053426 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Feb 2006. https://www.510kdatabase.net/k053576/ 2006-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k053576-dimension-vista-myo-reagent-cartridge-fda-510k.jpg K053576 - DIMENSION VISTA MYO REAGENT CARTRIDGE AND CALIBRATOR K053576 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Feb 2006. https://www.510kdatabase.net/k060055/ 2006-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k060055-kodak-pacs-fda-510k.jpg K060055 - KODAK PACS K060055 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Feb 2006. https://www.510kdatabase.net/k053061/ 2006-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k053061-emit-2000-cyclosporine-specific-assay-fda-510k.jpg K053061 - EMIT 2000 CYCLOSPORINE SPECIFIC ASSAY K053061 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Dade Behring, Inc.. Cleared Feb 2006. https://www.510kdatabase.net/k053390/ 2006-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k053390-columbus-cr-total-knee-system-fda-510k.jpg K053390 - COLUMBUS (CR) TOTAL KNEE SYSTEM K053390 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aesculap, Inc.. Cleared Feb 2006. https://www.510kdatabase.net/k060107/ 2006-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k060107-modification-to-exactech-ziramic-fda-510k.jpg K060107 - MODIFICATION TO: EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS K060107 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Feb 2006. https://www.510kdatabase.net/k051217/ 2006-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k051217-datex-ohmeda-prestin-module-model-fda-510k.jpg K051217 - DATEX-OHMEDA PRESTIN MODULE (MODEL FAMILY E-PRESTIN, INCLUDING E-PRESTIN, E-RESTIN, E=PRETIN, E-PP AND E-PT/E-P) K051217 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Healthcare. Cleared Feb 2006. https://www.510kdatabase.net/k053500/ 2006-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k053500-frameless-radiosurgery-components-fda-510k.jpg K053500 - FRAMELESS RADIOSURGERY COMPONENTS K053500 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab AG. Cleared Feb 2006. https://www.510kdatabase.net/k060060/ 2006-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k060060-biograph-6-fda-510k.jpg K060060 - BIOGRAPH 6 K060060 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 2006. https://www.510kdatabase.net/k060088/ 2006-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k060088-microscan-synergies-plus-gram-positive-fda-510k.jpg K060088 - MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS - AMPICILLIN K060088 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Feb 2006. https://www.510kdatabase.net/k060152/ 2006-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k060152-modification-to-s4-spinal-system-fda-510k.jpg K060152 - MODIFICATION TO S4 SPINAL SYSTEM K060152 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aesculap, Inc.. Cleared Feb 2006. https://www.510kdatabase.net/k053226/ 2006-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k053226-zimmer-ambulatory-pump-pain-management-fda-510k.jpg K053226 - ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEMS WITH FENESTRATED CATHETER AND FLOW SPLITTER K053226 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zimmer, Inc.. Cleared Jan 2006. https://www.510kdatabase.net/k060031/ 2006-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k060031-depuy-modular-m-heads-fda-510k.jpg K060031 - DEPUY MODULAR M HEADS K060031 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jan 2006. https://www.510kdatabase.net/k060078/ 2006-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k060078-fibered-idc-occlusion-system-fda-510k.jpg K060078 - FIBERED IDC OCCLUSION SYSTEM K060078 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Jan 2006. https://www.510kdatabase.net/k052915/ 2006-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k052915-profemur-xtr-hip-stem-fda-510k.jpg K052915 - PROFEMUR XTR HIP STEM K052915 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jan 2006. https://www.510kdatabase.net/k053198/ 2006-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k053198-simplex-p-speedset-bone-cement-fda-510k.jpg K053198 - SIMPLEX P SPEEDSET BONE CEMENT K053198 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jan 2006. https://www.510kdatabase.net/k053338/ 2006-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k053338-arthrex-titanium-and-bio-degradable-fda-510k.jpg K053338 - ARTHREX TITANIUM AND BIO-DEGRADABLE (POLYMER) IMPLANTS K053338 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jan 2006. https://www.510kdatabase.net/k053642/ 2006-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k053642-osteoset-dbm-pellets-fda-510k.jpg K053642 - OSTEOSET DBM PELLETS K053642 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jan 2006. https://www.510kdatabase.net/k053574/ 2006-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k053574-medline-pediatric-wheelchairs-fda-510k.jpg K053574 - MEDLINE PEDIATRIC WHEELCHAIRS K053574 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Medline Industries, Inc.. Cleared Jan 2006. https://www.510kdatabase.net/k052773/ 2006-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k052773-b-braun-02-micron-filter-fda-510k.jpg K052773 - B. BRAUN 0.2 MICRON FILTER K052773 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Jan 2006. https://www.510kdatabase.net/k052680/ 2006-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k052680-calculase-holmium-laser-system-and-fda-510k.jpg K052680 - CALCULASE HOLMIUM LASER SYSTEM AND ACCESSORIES K052680 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jan 2006. https://www.510kdatabase.net/k053022/ 2006-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k053022-synthes-usa-chronos-beta-tcp-fda-510k.jpg K053022 - SYNTHES (USA) CHRONOS-BETA-TCP K053022 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Jan 2006. https://www.510kdatabase.net/k051400/ 2006-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k051400-datex-ohmeda-s5-anesthesia-monitor-fda-510k.jpg K051400 - DATEX-OHMEDA S/5 ANESTHESIA MONITOR WITH L-ANEO5 AND L-ANEO5A SOFTWARE, USING F-CU8 OR F-CU5(P) MONITOR FRAME OPTIONS K051400 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Healthcare. Cleared Jan 2006. https://www.510kdatabase.net/k052975/ 2006-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k052975-datex-ohmeda-s5-web-viewer-datex-fda-510k.jpg K052975 - DATEX-OHMEDA S/5 WEB VIEWER, DATEX-OHMEDA S/5 POCKET VIEWER AND DATEX-OHMEDA S/5 CELLULAR VIEWER WITH L-WEB04 SOFTWARE K052975 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Healthcare. Cleared Jan 2006. https://www.510kdatabase.net/k053107/ 2006-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k053107-codman-hakim-programmable-valve-wwo-fda-510k.jpg K053107 - CODMAN HAKIM PROGRAMMABLE VALVE W/WO SIPHONGUARD K053107 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Jan 2006. https://www.510kdatabase.net/k053171/ 2006-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k053171-merit-impress-diagnostic-catheter-fda-510k.jpg K053171 - MERIT IMPRESS DIAGNOSTIC CATHETER K053171 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jan 2006. https://www.510kdatabase.net/k053350/ 2006-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k053350-modification-to-codman-hakim-shunt-fda-510k.jpg K053350 - MODIFICATION TO CODMAN HAKIM SHUNT SYSTEMS K053350 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Jan 2006. https://www.510kdatabase.net/k053158/ 2006-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k053158-optilene-mesh-lp-fda-510k.jpg K053158 - OPTILENE MESH LP K053158 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Jan 2006. https://www.510kdatabase.net/k053526/ 2006-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k053526-microspeed-uni-motor-system-fda-510k.jpg K053526 - MICROSPEED UNI MOTOR SYSTEM K053526 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Jan 2006. https://www.510kdatabase.net/k052976/ 2006-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k052976-datex-ohmeda-s5-cardiac-output-module-fda-510k.jpg K052976 - DATEX-OHMEDA S/5 CARDIAC OUTPUT MODULE, E-COP AND ACCESSORIES K052976 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Healthcare. Cleared Jan 2006. https://www.510kdatabase.net/k053499/ 2006-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k053499-hemosil-pros-fda-510k.jpg K053499 - HEMOSIL PROS K053499 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jan 2006. https://www.510kdatabase.net/k053588/ 2006-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k053588-profemur-lx-hip-stem-fda-510k.jpg K053588 - PROFEMUR LX HIP STEM K053588 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jan 2006. https://www.510kdatabase.net/k052459/ 2006-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k052459-6248val-adjustable-valve-fda-510k.jpg K052459 - 6248VAL ADJUSTABLE VALVE K052459 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jan 2006. https://www.510kdatabase.net/k053472/ 2006-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k053472-hoffmann-ii-mri-external-fixation-system-fda-510k.jpg K053472 - HOFFMANN II MRI EXTERNAL FIXATION SYSTEM K053472 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jan 2006. https://www.510kdatabase.net/k052964/ 2006-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k052964-exxcel-and-exxcel-soft-eptfe-vascular-fda-510k.jpg K052964 - EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED VASCULAR GRAFTS, WOVEN DOUBLE VELOUR WOVEN K052964 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Jan 2006. https://www.510kdatabase.net/k053445/ 2006-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k053445-smartmix-cemvac-pre-filled-with-fda-510k.jpg K053445 - SMARTMIX CEMVAC PRE-FILLED WITH SMARTSET HV BONE CEMENT K053445 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jan 2006. https://www.510kdatabase.net/k053474/ 2006-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k053474-cd-horizon-spinal-system-fda-510k.jpg K053474 - CD HORIZON SPINAL SYSTEM K053474 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Jan 2006. https://www.510kdatabase.net/k053101/ 2006-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k053101-cd-horizon-spinal-system-fda-510k.jpg K053101 - CD HORIZON SPINAL SYSTEM K053101 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Jan 2006. https://www.510kdatabase.net/k053136/ 2006-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k053136-5th-metatarsal-fracture-screw-fda-510k.jpg K053136 - 5TH METATARSAL FRACTURE SCREW K053136 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jan 2006. https://www.510kdatabase.net/k053483/ 2006-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k053483-modification-to-vertex-reconstruction-fda-510k.jpg K053483 - MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM K053483 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Jan 2006. https://www.510kdatabase.net/k051880/ 2006-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k051880-rio-aspiration-catheter-fda-510k.jpg K051880 - RIO ASPIRATION CATHETER K051880 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Jan 2006. https://www.510kdatabase.net/k053347/ 2006-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k053347-kodak-carestream-pacs-fda-510k.jpg K053347 - KODAK CARESTREAM PACS K053347 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Jan 2006. https://www.510kdatabase.net/k053016/ 2005-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k053016-wireless-physiologic-monitoring-system-fda-510k.jpg K053016 - WIRELESS PHYSIOLOGIC MONITORING SYSTEM K053016 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Dec 2005. https://www.510kdatabase.net/k052972/ 2005-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k052972-datex-ohmeda-network-and-icentral-05-fda-510k.jpg K052972 - DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3 K052972 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Healthcare. Cleared Dec 2005. https://www.510kdatabase.net/k052425/ 2005-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k052425-zimmer-computer-assisted-solutions-fda-510k.jpg K052425 - ZIMMER COMPUTER ASSISTED SOLUTIONS-ELECTROMAGNETIC AND IMAGELESS KNEE INSTRUMENTATION K052425 is a FDA 510(k) cleared neurology medical device. Manufacturer: Zimmer, Inc.. Cleared Dec 2005. https://www.510kdatabase.net/k052265/ 2005-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k052265-smith-nephew-competitor-duo-knee-femoral-fda-510k.jpg K052265 - SMITH & NEPHEW COMPETITOR DUO KNEE FEMORAL K052265 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Dec 2005. https://www.510kdatabase.net/k052787/ 2005-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k052787-acumatch-1214-c-series-cemented-fda-510k.jpg K052787 - ACUMATCH 12/14 C-SERIES CEMENTED FEMORAL STEMS (SIZE 1-6), ACUMATCH 12/14 L-SERIES CEMENTED FEMORAL STEMS (SIZE 1-5) K052787 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Dec 2005. https://www.510kdatabase.net/k052917/ 2005-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k052917-stryker-compartmental-knee-system-fda-510k.jpg K052917 - STRYKER COMPARTMENTAL KNEE SYSTEM K052917 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Dec 2005. https://www.510kdatabase.net/k051030/ 2005-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k051030-coag-a-mate-mtx-iii-fda-510k.jpg K051030 - COAG-A-MATE MTX III K051030 is a FDA 510(k) cleared hematology medical device. Manufacturer: bioMerieux, Inc.. Cleared Dec 2005. https://www.510kdatabase.net/k053104/ 2005-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k053104-dimension-cardiophase-high-sensitivity-fda-510k.jpg K053104 - DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATOR K053104 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Dec 2005. https://www.510kdatabase.net/k053109/ 2005-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k053109-dimension-cardiophase-high-sensitivity-fda-510k.jpg K053109 - DIMENSION CARDIOPHASE HIGH SENSITIVITY CRP FLEX REAGENT CARTRIDGE K053109 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Dec 2005. https://www.510kdatabase.net/k053241/ 2005-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k053241-bd-phoenix-automated-microbiology-fda-510k.jpg K053241 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOXITIN GP 1-32 G/ML K053241 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Dec 2005. https://www.510kdatabase.net/k053404/ 2005-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k053404-lifestent-flexstart-biliary-stent-system-fda-510k.jpg K053404 - LIFESTENT FLEXSTART BILIARY STENT SYSTEM K053404 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Dec 2005. https://www.510kdatabase.net/k052906/ 2005-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k052906-zimmer-trabecular-metal-reverse-fda-510k.jpg K052906 - ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM K052906 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Dec 2005. https://www.510kdatabase.net/k053262/ 2005-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k053262-ksea-unidrive-entneuroomfs-system-and-fda-510k.jpg K053262 - KSEA UNIDRIVE ENT/NEURO/OMFS SYSTEM AND ACCESSORIES K053262 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Dec 2005. https://www.510kdatabase.net/k051386/ 2005-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k051386-mastergraft-putty-bone-void-filler-fda-510k.jpg K051386 - MASTERGRAFT PUTTY BONE VOID FILLER K051386 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Vascular. Cleared Dec 2005. https://www.510kdatabase.net/k052990/ 2005-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k052990-stageone-disposable-cement-spacer-mold-fda-510k.jpg K052990 - STAGEONE DISPOSABLE CEMENT SPACER MOLD FOR TEMPORARY HIP PROSTHESIS WITH REINFORCEMENT STEM K052990 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Dec 2005. https://www.510kdatabase.net/k053090/ 2005-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k053090-dri-stat-enzymatic-bilirubin-reagent-fda-510k.jpg K053090 - DRI-STAT ENZYMATIC BILIRUBIN REAGENT, SYNCHRON SYSTEMS BILIRUBIN CALIBRATOR K053090 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Dec 2005. https://www.510kdatabase.net/k053116/ 2005-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k053116-sterling-otw-pta-balloon-dilatation-fda-510k.jpg K053116 - STERLING OTW PTA BALLOON DILATATION CATHETER, MODEL H74939032-XXXXXX K053116 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Dec 2005. https://www.510kdatabase.net/k053118/ 2005-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k053118-sterling-monorail-pta-balloon-fda-510k.jpg K053118 - STERLING MONORAIL PTA BALLOON DILATATION CATHETER, MODEL H74939031-XXXXXX K053118 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Dec 2005. https://www.510kdatabase.net/k053252/ 2005-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k053252-u-clip-device-models-b140-b160-and-b180-fda-510k.jpg K053252 - U-CLIP DEVICE, MODELS B140, B160 AND B180 K053252 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medtronic Vascular. Cleared Dec 2005. https://www.510kdatabase.net/k053256/ 2005-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k053256-3m-tegaderm-silver-ag-mesh-fda-510k.jpg K053256 - 3M TEGADERM SILVER (AG) MESH K053256 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3M Company. Cleared Dec 2005. https://www.510kdatabase.net/k053330/ 2005-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k053330-architect-b12-calibrators-fda-510k.jpg K053330 - ARCHITECT B12 CALIBRATORS K053330 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Dec 2005. https://www.510kdatabase.net/k053435/ 2005-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k053435-ge-voluson-i-fda-510k.jpg K053435 - GE VOLUSON I K053435 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Dec 2005. https://www.510kdatabase.net/k053097/ 2005-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k053097-vitek-2-gram-positive-cefoxitin-screen-fda-510k.jpg K053097 - VITEK 2 GRAM POSITIVE CEFOXITIN SCREEN K053097 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Dec 2005. https://www.510kdatabase.net/k053165/ 2005-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k053165-ise-indirect-na-k-cl-for-gen2-fda-510k.jpg K053165 - ISE INDIRECT NA, K, CL FOR GEN.2 K053165 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Dec 2005. https://www.510kdatabase.net/k053199/ 2005-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k053199-synthes-patient-specific-fda-510k.jpg K053199 - SYNTHES PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANT K053199 is a FDA 510(k) cleared neurology medical device. Manufacturer: Synthes (Usa). Cleared Dec 2005. https://www.510kdatabase.net/k052573/ 2005-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k052573-stardust-ii-fda-510k.jpg K052573 - STARDUST II K052573 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Dec 2005. https://www.510kdatabase.net/k052776/ 2005-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k052776-tightrope-acromioclavicular-ac-device-fda-510k.jpg K052776 - TIGHTROPE ACROMIOCLAVICULAR (AC) DEVICE, TITANIUM, STAINLESS STEEL , MODELS AR-2257, AR-TBD K052776 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Dec 2005. https://www.510kdatabase.net/k052901/ 2005-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k052901-arthrex-tensionlok-fda-510k.jpg K052901 - ARTHREX TENSIONLOK K052901 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Dec 2005. https://www.510kdatabase.net/k052539/ 2005-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k052539-cook-formula-418-biliary-stent-system-fda-510k.jpg K052539 - COOK FORMULA 418 BILIARY STENT SYSTEM K052539 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook, Inc.. Cleared Dec 2005. https://www.510kdatabase.net/k053157/ 2005-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k053157-automated-hdl-cholesterol-flex-reagent-fda-510k.jpg K053157 - AUTOMATED HDL CHOLESTEROL FLEX REAGENT CARTRIDGE, MODEL DF48A K053157 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Dec 2005. https://www.510kdatabase.net/k053189/ 2005-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k053189-coonradmorrey-total-elbow-model-8105-fda-510k.jpg K053189 - COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIES K053189 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Dec 2005. https://www.510kdatabase.net/k053346/ 2005-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k053346-modification-to-dp-9900-digital-fda-510k.jpg K053346 - MODIFICATION TO: DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-9900 K053346 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Dec 2005. https://www.510kdatabase.net/k053349/ 2005-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k053349-hoffmann-ii-rod-to-wire-coupling-fda-510k.jpg K053349 - HOFFMANN II ROD TO WIRE COUPLING K053349 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Dec 2005. https://www.510kdatabase.net/k052841/ 2005-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k052841-mira-flex-18-microcatheter-fda-510k.jpg K052841 - MIRA-FLEX 18 MICROCATHETER K052841 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Dec 2005. https://www.510kdatabase.net/k052275/ 2005-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k052275-smith-nephew-platform-hip-stem-fda-510k.jpg K052275 - SMITH & NEPHEW PLATFORM HIP STEM K052275 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Dec 2005. https://www.510kdatabase.net/k052426/ 2005-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k052426-smith-nephew-modular-hip-fda-510k.jpg K052426 - SMITH & NEPHEW MODULAR HIP K052426 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Dec 2005. https://www.510kdatabase.net/k053200/ 2005-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k053200-gore-seamguard-staple-line-fda-510k.jpg K053200 - GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL K053200 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Dec 2005. https://www.510kdatabase.net/k051382/ 2005-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k051382-elecsys-probnp-immunoassay-fda-510k.jpg K051382 - ELECSYS PROBNP IMMUNOASSAY K051382 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Dec 2005. https://www.510kdatabase.net/k051484/ 2005-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k051484-zeus-scientific-inc-athena-multi-lyte-fda-510k.jpg K051484 - ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM. K051484 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Dec 2005. https://www.510kdatabase.net/k052026/ 2005-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k052026-lineage-a-class-poly-liner-fda-510k.jpg K052026 - LINEAGE A-CLASS POLY LINER K052026 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Dec 2005. https://www.510kdatabase.net/k052683/ 2005-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k052683-synthes-usa-sternal-fixation-system-fda-510k.jpg K052683 - SYNTHES (USA) STERNAL FIXATION SYSTEM K052683 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Dec 2005. https://www.510kdatabase.net/k053133/ 2005-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k053133-syngo-dynamics-version-50-fda-510k.jpg K053133 - SYNGO DYNAMICS, VERSION 5.0 K053133 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Dec 2005. https://www.510kdatabase.net/k052748/ 2005-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k052748-system-12-x3-acetabular-inserts-fda-510k.jpg K052748 - SYSTEM 12 X3 ACETABULAR INSERTS K052748 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Dec 2005. https://www.510kdatabase.net/k053105/ 2005-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k053105-synthes-usa-elastic-intramedullary-fda-510k.jpg K053105 - SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) END CAP K053105 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Dec 2005. https://www.510kdatabase.net/k051858/ 2005-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k051858-acumatch-m-series-lpb-1214-femoral-stem-fda-510k.jpg K051858 - ACUMATCH M-SERIES LPB 12/14 FEMORAL STEM K051858 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Dec 2005. https://www.510kdatabase.net/k053186/ 2005-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k053186-vitek-2-gram-positive-telithromycin-fda-510k.jpg K053186 - VITEK 2 GRAM POSITIVE TELITHROMYCIN FOR STREPTOCOCCUS PNEUMONIAE K053186 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Dec 2005. https://www.510kdatabase.net/k053128/ 2005-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k053128-soloist-single-needle-electrodeelectrode-fda-510k.jpg K053128 - SOLOIST SINGLE NEEDLE ELECTRODEELECTRODE K053128 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Boston Scientific Corp. Cleared Nov 2005. https://www.510kdatabase.net/k052387/ 2005-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k052387-arthrex-fingershield-finger-guard-fda-510k.jpg K052387 - ARTHREX FINGERSHIELD FINGER GUARD, MODEL AR-7199-XX K052387 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Arthrex, Inc.. Cleared Nov 2005. https://www.510kdatabase.net/k052401/ 2005-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k052401-gynecare-tvt-secur-system-fda-510k.jpg K052401 - GYNECARE TVT SECUR SYSTEM K052401 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ethicon, Inc.. Cleared Nov 2005. https://www.510kdatabase.net/k052481/ 2005-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k052481-bd-viper-system-fda-510k.jpg K052481 - BD VIPER SYSTEM K052481 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Nov 2005. https://www.510kdatabase.net/k053059/ 2005-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k053059-roche-diagnostics-elecsys-prolactin-ii-fda-510k.jpg K053059 - ROCHE DIAGNOSTICS ELECSYS PROLACTIN II CALCHECK K053059 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Nov 2005. https://www.510kdatabase.net/k050209/ 2005-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k050209-smith-nephew-control-digital-operating-fda-510k.jpg K050209 - SMITH & NEPHEW CONTROL DIGITAL OPERATING ROOM SYSTEM K050209 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Nov 2005. https://www.510kdatabase.net/k052255/ 2005-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k052255-arcomxl-polyethylene-rx90-acetabular-fda-510k.jpg K052255 - ARCOMXL POLYETHYLENE RX90 ACETABULAR LINERS K052255 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Nov 2005. https://www.510kdatabase.net/k052264/ 2005-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k052264-quanta-lite-ccp3-igg-elisa-fda-510k.jpg K052264 - QUANTA LITE CCP3 IGG ELISA K052264 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Nov 2005. https://www.510kdatabase.net/k052834/ 2005-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k052834-mreye-embolization-coil-fda-510k.jpg K052834 - MREYE EMBOLIZATION COIL K052834 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Nov 2005. https://www.510kdatabase.net/k052894/ 2005-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k052894-sonoline-g60-s-ultrasound-system-fda-510k.jpg K052894 - SONOLINE G60 S ULTRASOUND SYSTEM K052894 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2005. https://www.510kdatabase.net/k052879/ 2005-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k052879-nexgen-complete-knee-solution-mis-fda-510k.jpg K052879 - NEXGEN COMPLETE KNEE SOLUTION MIS MODULAR TIBIAL PLATES AND KEELS K052879 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Nov 2005. https://www.510kdatabase.net/k052977/ 2005-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k052977-datex-ohmeda-s5-cardiac-output-and-fda-510k.jpg K052977 - DATEX-OHMEDA S/5 CARDIAC OUTPUT AND SVO2 MODULE, E-COPSV AND ACCESSORIES K052977 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Healthcare. Cleared Nov 2005. https://www.510kdatabase.net/k053002/ 2005-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k053002-depuy-cmw-1-gentamicin-bone-cement-fda-510k.jpg K053002 - DEPUY CMW 1 GENTAMICIN BONE CEMENT K053002 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Nov 2005. https://www.510kdatabase.net/k053003/ 2005-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k053003-depuy-cmw-1-2-and-3-bone-cements-fda-510k.jpg K053003 - DEPUY CMW 1, 2 AND 3 BONE CEMENTS K053003 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Nov 2005. https://www.510kdatabase.net/k053038/ 2005-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k053038-hoffmann-ii-compact-mri-external-fda-510k.jpg K053038 - HOFFMANN II COMPACT MRI EXTERNAL FIXATION SYSTEM K053038 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Nov 2005. https://www.510kdatabase.net/k050398/ 2005-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k050398-exactech-ziramic-zirconia-1214-femoral-fda-510k.jpg K050398 - EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS K050398 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Nov 2005. https://www.510kdatabase.net/k051722/ 2005-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k051722-tricos-t-fda-510k.jpg K051722 - TRICOS T K051722 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Baxter Healthcare Corp. Cleared Nov 2005. https://www.510kdatabase.net/k052905/ 2005-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k052905-modification-to-coulter-lh-750-fda-510k.jpg K052905 - MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER K052905 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Nov 2005. https://www.510kdatabase.net/k053043/ 2005-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k053043-encompass-software-package-fda-510k.jpg K053043 - ENCOMPASS SOFTWARE PACKAGE K053043 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Nov 2005. https://www.510kdatabase.net/k052413/ 2005-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k052413-tuna-system-models-8909-8929-8930-8934-fda-510k.jpg K052413 - TUNA SYSTEM, MODELS 8909, 8929, 8930, 8934 K052413 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medtronic Vascular. Cleared Nov 2005. https://www.510kdatabase.net/k052853/ 2005-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k052853-tigecycline-15ug-bbl-sensi-disc-fda-510k.jpg K052853 - TIGECYCLINE 15UG BBL SENSI-DISC K052853 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Nov 2005. https://www.510kdatabase.net/k053009/ 2005-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k053009-ge-035t-signa-ovation-with-excite-mr-fda-510k.jpg K053009 - GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM K053009 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Nov 2005. https://www.510kdatabase.net/k052252/ 2005-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k052252-contrast-media-transfer-sets-fda-510k.jpg K052252 - CONTRAST MEDIA TRANSFER SETS K052252 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Nov 2005. https://www.510kdatabase.net/k052931/ 2005-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k052931-modification-to-verte-stack-spinal-fda-510k.jpg K052931 - MODIFICATION TO VERTE-STACK SPINAL SYSTEM K052931 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Nov 2005. https://www.510kdatabase.net/k052876/ 2005-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k052876-telithromycin-15ug-bbl-sensi-disc-fda-510k.jpg K052876 - TELITHROMYCIN 15UG BBL SENSI-DISC K052876 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Nov 2005. https://www.510kdatabase.net/k052331/ 2005-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k052331-acuson-cypress-ultrasound-system-fda-510k.jpg K052331 - ACUSON CYPRESS ULTRASOUND SYSTEM K052331 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2005. https://www.510kdatabase.net/k052393/ 2005-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k052393-b-braun-modified-bicarbonate-dialysate-fda-510k.jpg K052393 - B. BRAUN MODIFIED BICARBONATE DIALYSATE K052393 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Nov 2005. https://www.510kdatabase.net/k052838/ 2005-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k052838-liquichek-diabetes-control-level-1234-fda-510k.jpg K052838 - LIQUICHEK DIABETES CONTROL, LEVEL 1,2,3,4 K052838 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Nov 2005. https://www.510kdatabase.net/k042691/ 2005-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k042691-vertefix-vertebroplasty-procedure-set-fda-510k.jpg K042691 - VERTEFIX VERTEBROPLASTY PROCEDURE SET K042691 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Cook, Inc.. Cleared Nov 2005. https://www.510kdatabase.net/k052995/ 2005-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k052995-advantage-workstation-43-fda-510k.jpg K052995 - ADVANTAGE WORKSTATION 4.3. K052995 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Nov 2005. https://www.510kdatabase.net/k052280/ 2005-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k052280-filterwire-ez-embolic-protection-system-fda-510k.jpg K052280 - FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM K052280 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Nov 2005. https://www.510kdatabase.net/k052607/ 2005-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k052607-arthrex-interference-screw-rounded-fda-510k.jpg K052607 - ARTHREX INTERFERENCE SCREW-ROUNDED HEAD SCREWS, FULL THREADED SCREWS, SHEATHED CANNULATED INTERFERENCE SCREWS K052607 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Nov 2005. https://www.510kdatabase.net/k052656/ 2005-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k052656-vitek-gram-positive-susceptibility-fda-510k.jpg K052656 - VITEK GRAM POSITIVE SUSCEPTIBILITY DAPTOMYCIN K052656 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Nov 2005. https://www.510kdatabase.net/k052913/ 2005-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k052913-ignite-bone-void-filler-kit-fda-510k.jpg K052913 - IGNITE BONE VOID FILLER KIT K052913 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Nov 2005. https://www.510kdatabase.net/k052483/ 2005-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k052483-synthes-usa-spherical-washers-fda-510k.jpg K052483 - SYNTHES (USA) SPHERICAL WASHERS K052483 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Nov 2005. https://www.510kdatabase.net/k052736/ 2005-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k052736-arthrex-k-wire-threaded-models-ar-8990-fda-510k.jpg K052736 - ARTHREX K-WIRE ,THREADED MODELS AR-8990 TO 899X, AR-8991T TO AR-899XT K052736 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Nov 2005. https://www.510kdatabase.net/k052213/ 2005-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k052213-navigation-sw-hip-31-on-ci-fda-510k.jpg K052213 - NAVIGATION SW HIP 3.1 ON CI K052213 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Nov 2005. https://www.510kdatabase.net/k052880/ 2005-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k052880-datex-ohmeda-s5-interface-module-e-int-fda-510k.jpg K052880 - DATEX-OHMEDA S/5 INTERFACE MODULE E-INT K052880 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Ge Healthcare. Cleared Nov 2005. https://www.510kdatabase.net/k052756/ 2005-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k052756-datex-ohmeda-s5-memory-module-e-mem-fda-510k.jpg K052756 - DATEX-OHMEDA S/5 MEMORY MODULE, E-MEM K052756 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Healthcare. Cleared Nov 2005. https://www.510kdatabase.net/k051276/ 2005-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k051276-hysafe-micro-modular-forceps-and-fda-510k.jpg K051276 - HYSAFE MICRO MODULAR FORCEPS AND SCISSORS SYSTEM K051276 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Oct 2005. https://www.510kdatabase.net/k052747/ 2005-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k052747-modification-tocd-horizon-spinal-system-fda-510k.jpg K052747 - MODIFICATION TO:CD HORIZON SPINAL SYSTEM K052747 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Oct 2005. https://www.510kdatabase.net/k052855/ 2005-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k052855-starspeed-series-ct-scanner-systems-fda-510k.jpg K052855 - STARSPEED SERIES CT SCANNER SYSTEMS K052855 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Oct 2005. https://www.510kdatabase.net/k052982/ 2005-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k052982-roche-diagnostics-cobas-elecsys-fda-510k.jpg K052982 - ROCHE DIAGNOSTICS COBAS ELECSYS PROLACTIN II CALSET K052982 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Oct 2005. https://www.510kdatabase.net/k052262/ 2005-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k052262-quanta-lite-m2-ep-mit3-elisa-fda-510k.jpg K052262 - QUANTA LITE M2 EP (MIT3) ELISA K052262 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Oct 2005. https://www.510kdatabase.net/k052685/ 2005-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k052685-orthopedic-salvage-system-oss-fda-510k.jpg K052685 - ORTHOPEDIC SALVAGE SYSTEM- OSS K052685 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Oct 2005. https://www.510kdatabase.net/k052718/ 2005-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k052718-v40-biolox-delta-ceramic-femoral-heads-fda-510k.jpg K052718 - V40 BIOLOX DELTA CERAMIC FEMORAL HEADS K052718 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Oct 2005. https://www.510kdatabase.net/k052783/ 2005-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k052783-modification-to-iq-guide-wire-models-fda-510k.jpg K052783 - MODIFICATION TO: IQ GUIDE WIRE, MODELS 38950-XX. 38951-XX K052783 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Oct 2005. https://www.510kdatabase.net/k052895/ 2005-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k052895-foursight-viewtool-image-viewer-fda-510k.jpg K052895 - FOURSIGHT VIEWTOOL IMAGE VIEWER K052895 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 2005. https://www.510kdatabase.net/k052346/ 2005-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k052346-synergies-plus-gram-positive-miccombo-fda-510k.jpg K052346 - SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS K052346 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Oct 2005. https://www.510kdatabase.net/k052884/ 2005-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k052884-model-dfp-8000dfpd-digital-radiography-fda-510k.jpg K052884 - MODEL DFP-8000D/FPD DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR K052884 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Oct 2005. https://www.510kdatabase.net/k052543/ 2005-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k052543-heraceram-zirkonia-fda-510k.jpg K052543 - HERACERAM ZIRKONIA K052543 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Oct 2005. https://www.510kdatabase.net/k051948/ 2005-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k051948-avon-patello-femoral-joint-prosthesis-fda-510k.jpg K051948 - AVON PATELLO-FEMORAL JOINT PROSTHESIS K051948 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Oct 2005. https://www.510kdatabase.net/k052079/ 2005-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k052079-pinnacle-constrained-acetabular-liners-fda-510k.jpg K052079 - PINNACLE CONSTRAINED ACETABULAR LINERS K052079 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Oct 2005. https://www.510kdatabase.net/k052121/ 2005-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k052121-gem-premier-3000-fda-510k.jpg K052121 - GEM PREMIER 3000 K052121 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Oct 2005. https://www.510kdatabase.net/k052178/ 2005-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k052178-depuy-cas-hip-instrumentation-fda-510k.jpg K052178 - DEPUY CAS HIP INSTRUMENTATION K052178 is a FDA 510(k) cleared neurology medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Oct 2005. https://www.510kdatabase.net/k052609/ 2005-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k052609-modification-to-cd-horizon-spinal-system-fda-510k.jpg K052609 - MODIFICATION TO CD HORIZON SPINAL SYSTEM K052609 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Oct 2005. https://www.510kdatabase.net/k052652/ 2005-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k052652-smith-nephew-continuous-loop-fixation-fda-510k.jpg K052652 - SMITH & NEPHEW CONTINUOUS LOOP FIXATION DEVICE K052652 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 2005. https://www.510kdatabase.net/k052734/ 2005-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k052734-modification-to-vertex-reconstruction-fda-510k.jpg K052734 - MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM K052734 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Oct 2005. https://www.510kdatabase.net/k051991/ 2005-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k051991-powerpicc-poly-per-q-cath-6-fr-tl-poly-fda-510k.jpg K051991 - POWERPICC, POLY PER-Q-CATH, 6 FR TL POLY PER-Q-CATH, POWER HOHN AND POWER LINE K051991 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 2005. https://www.510kdatabase.net/k052110/ 2005-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k052110-m-series-pro-cpap-sytem-fda-510k.jpg K052110 - M-SERIES PRO CPAP SYTEM K052110 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Oct 2005. https://www.510kdatabase.net/k052155/ 2005-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k052155-bard-large-pore-soft-mesh-and-soft-fda-510k.jpg K052155 - BARD LARGE PORE SOFT MESH AND SOFT MESH PRESHAPED K052155 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 2005. https://www.510kdatabase.net/k052720/ 2005-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k052720-medline-iodoform-packing-strips-fda-510k.jpg K052720 - MEDLINE IODOFORM PACKING STRIPS K052720 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medline Industries, Inc.. Cleared Oct 2005. https://www.510kdatabase.net/k051543/ 2005-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k051543-elecsys-precicontrol-bone-fda-510k.jpg K051543 - ELECSYS PRECICONTROL BONE K051543 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Oct 2005. https://www.510kdatabase.net/k052449/ 2005-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k052449-cadman-integrated-irrigation-tubing-fda-510k.jpg K052449 - CADMAN INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET, MODELS 80-1163, 80-1189 K052449 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Oct 2005. https://www.510kdatabase.net/k052582/ 2005-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k052582-datex-ohmeda-s5-single-width-airway-fda-510k.jpg K052582 - DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES K052582 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Ge Healthcare. Cleared Oct 2005. https://www.510kdatabase.net/k052171/ 2005-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k052171-zimmer-ambulatory-pump-pain-management-fda-510k.jpg K052171 - ZIMMER AMBULATORY PUMP PAIN MANAGEMENT SYSTEM WITH PATIENT CONTROL MODULE K052171 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zimmer, Inc.. Cleared Oct 2005. https://www.510kdatabase.net/k052755/ 2005-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k052755-datex-ohmeda-s5-nellcor-compatible-fda-510k.jpg K052755 - DATEX-OHMEDA S/5 NELLCOR COMPATIBLE SATURATION MODULE, E-NSAT K052755 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Ge Healthcare. Cleared Oct 2005. https://www.510kdatabase.net/k051977/ 2005-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k051977-scorpio-knee-system-tibial-inserts-and-fda-510k.jpg K051977 - SCORPIO KNEE SYSTEM TIBIAL INSERTS AND PATELLAR COMPONENTS K051977 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Oct 2005. https://www.510kdatabase.net/k052677/ 2005-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k052677-synthes-universal-locking-trochanter-fda-510k.jpg K052677 - SYNTHES UNIVERSAL LOCKING TROCHANTER STABILIZATION PLATE (ULTSP) K052677 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Oct 2005. https://www.510kdatabase.net/k052261/ 2005-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k052261-modification-to-verte-stack-spinal-fda-510k.jpg K052261 - MODIFICATION TO: VERTE-STACK SPINAL SYSTEM K052261 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Oct 2005. https://www.510kdatabase.net/k052390/ 2005-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k052390-synthes-lcp-proximal-tibia-plates-line-fda-510k.jpg K052390 - SYNTHES LCP PROXIMAL TIBIA PLATES LINE EXTENSION K052390 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Oct 2005. https://www.510kdatabase.net/k052640/ 2005-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k052640-gemini-raptor-fda-510k.jpg K052640 - GEMINI RAPTOR K052640 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Oct 2005. https://www.510kdatabase.net/k052792/ 2005-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k052792-anthology-hip-stem-fda-510k.jpg K052792 - ANTHOLOGY HIP STEM K052792 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 2005. https://www.510kdatabase.net/k052472/ 2005-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k052472-depuy-global-shoulder-crosslink-glenoid-fda-510k.jpg K052472 - DEPUY GLOBAL SHOULDER CROSSLINK GLENOID K052472 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Oct 2005. https://www.510kdatabase.net/k051176/ 2005-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k051176-flexible-video-cystoscopecholedochoscope-fda-510k.jpg K051176 - FLEXIBLE VIDEO CYSTOSCOPE/CHOLEDOCHOSCOPE, MODELS 7308.061 AND 7308.066 K051176 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Oct 2005. https://www.510kdatabase.net/k051879/ 2005-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k051879-synthes-usa-porous-polyethylene-implants-fda-510k.jpg K051879 - SYNTHES (USA) POROUS POLYETHYLENE IMPLANTS K051879 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Synthes (Usa). Cleared Oct 2005. https://www.510kdatabase.net/k052270/ 2005-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k052270-bd-phoenix-automated-microbiology-fda-510k.jpg K052270 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFUROXIME (STREP) 0.125 - 4UG/ML K052270 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Oct 2005. https://www.510kdatabase.net/k050124/ 2005-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k050124-porous-coated-acetabular-components-fda-510k.jpg K050124 - POROUS COATED ACETABULAR COMPONENTS K050124 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Oct 2005. https://www.510kdatabase.net/k052142/ 2005-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k052142-quanta-lite-gliadin-igg-ii-fda-510k.jpg K052142 - QUANTA LITE GLIADIN IGG II K052142 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Oct 2005. https://www.510kdatabase.net/k052143/ 2005-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k052143-quanta-lite-gliadin-iga-ii-fda-510k.jpg K052143 - QUANTA LITE GLIADIN IGA II K052143 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Oct 2005. https://www.510kdatabase.net/k052164/ 2005-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k052164-magnetom-systems-with-software-syngo-fda-510k.jpg K052164 - MAGNETOM SYSTEMS WITH SOFTWARE SYNGO MR 2006A K052164 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 2005. https://www.510kdatabase.net/k052193/ 2005-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k052193-ise-compensator-fda-510k.jpg K052193 - ISE COMPENSATOR K052193 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Oct 2005. https://www.510kdatabase.net/k052269/ 2005-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k052269-bd-phoenix-automated-microbiology-fda-510k.jpg K052269 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -CIPROFLOXACIN GN K052269 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Oct 2005. https://www.510kdatabase.net/k052220/ 2005-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k052220-iplan-rt-fibertracking-fda-510k.jpg K052220 - IPLAN RT FIBERTRACKING K052220 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab AG. Cleared Sep 2005. https://www.510kdatabase.net/k052250/ 2005-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k052250-bd-phoenix-automated-microbiology-fda-510k.jpg K052250 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TOBRAMYCIN (GP) 0.5-16UG/ML K052250 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Sep 2005. https://www.510kdatabase.net/k052464/ 2005-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k052464-tina-quant-hemoglobin-a1c-gen2-test-fda-510k.jpg K052464 - TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST K052464 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Sep 2005. https://www.510kdatabase.net/k043099/ 2005-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k043099-lineage-ha-acetabular-shells-fda-510k.jpg K043099 - LINEAGE HA ACETABULAR SHELLS K043099 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Sep 2005. https://www.510kdatabase.net/k051569/ 2005-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k051569-ringloc-bi-polar-acetabular-component-fda-510k.jpg K051569 - RINGLOC BI-POLAR ACETABULAR COMPONENT K051569 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Sep 2005. https://www.510kdatabase.net/k051701/ 2005-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k051701-vicryl-mesh-bag-fda-510k.jpg K051701 - VICRYL * MESH BAG K051701 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Sep 2005. https://www.510kdatabase.net/k051843/ 2005-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k051843-copeland-eas-humeral-resurfacing-heads-fda-510k.jpg K051843 - COPELAND EAS HUMERAL RESURFACING HEADS K051843 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Sep 2005. https://www.510kdatabase.net/k052311/ 2005-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k052311-vitek-2-gram-negative-tigecycline-fda-510k.jpg K052311 - VITEK 2 GRAM NEGATIVE TIGECYCLINE K052311 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Sep 2005. https://www.510kdatabase.net/k052517/ 2005-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k052517-site-rite-5-ultrasound-system-fda-510k.jpg K052517 - SITE-RITE 5 ULTRASOUND SYSTEM K052517 is a FDA 510(k) cleared radiology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Sep 2005. https://www.510kdatabase.net/k052614/ 2005-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k052614-low-profile-plate-and-screw-system-fda-510k.jpg K052614 - LOW PROFILE PLATE AND SCREW SYSTEM K052614 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Sep 2005. https://www.510kdatabase.net/k050327/ 2005-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k050327-e-poly-vitamin-e-acetabular-liners-fda-510k.jpg K050327 - E-POLY (VITAMIN E) ACETABULAR LINERS K050327 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Sep 2005. https://www.510kdatabase.net/k051726/ 2005-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k051726-arthrex-tenodesis-family-fda-510k.jpg K051726 - ARTHREX TENODESIS FAMILY K051726 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Sep 2005. https://www.510kdatabase.net/k051865/ 2005-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k051865-terumo-surguard-2-safety-needle-or-fda-510k.jpg K051865 - TERUMO SURGUARD 2 SAFETY NEEDLE OR SIMILAR K051865 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terumo Medical Corp.. Cleared Sep 2005. https://www.510kdatabase.net/k052235/ 2005-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k052235-lcr-fda-510k.jpg K052235 - LCR K052235 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Sep 2005. https://www.510kdatabase.net/k052434/ 2005-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k052434-hawkeye-4-option-for-dual-head-fda-510k.jpg K052434 - HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA K052434 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Sep 2005. https://www.510kdatabase.net/k052489/ 2005-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k052489-actiheart-fda-510k.jpg K052489 - ACTIHEART K052489 is a FDA 510(k) cleared neurology medical device. Manufacturer: Respironics, Inc.. Cleared Sep 2005. https://www.510kdatabase.net/k052123/ 2005-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k052123-synthes-pangea-system-fda-510k.jpg K052123 - SYNTHES PANGEA SYSTEM K052123 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Sep 2005. https://www.510kdatabase.net/k052376/ 2005-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k052376-modification-to-vertex-reconstruction-fda-510k.jpg K052376 - MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM K052376 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Sep 2005. https://www.510kdatabase.net/k052402/ 2005-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k052402-vertex-reconstruction-system-fda-510k.jpg K052402 - VERTEX RECONSTRUCTION SYSTEM K052402 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Sep 2005. https://www.510kdatabase.net/k052315/ 2005-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k052315-simtec-im-maxx-2-option-fda-510k.jpg K052315 - SIMTEC IM-MAXX 2 OPTION K052315 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 2005. https://www.510kdatabase.net/k052410/ 2005-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k052410-acuson-sequoia-ultrasound-system-fda-510k.jpg K052410 - ACUSON SEQUOIA ULTRASOUND SYSTEM K052410 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 2005. https://www.510kdatabase.net/k051678/ 2005-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k051678-synthes-hindfoot-arthrodesis-nail-system-fda-510k.jpg K051678 - SYNTHES HINDFOOT ARTHRODESIS NAIL SYSTEM K051678 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Sep 2005. https://www.510kdatabase.net/k052441/ 2005-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k052441-ge-logiq-7-ultrasound-bt05-fda-510k.jpg K052441 - GE LOGIQ 7 ULTRASOUND BT05 K052441 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Sep 2005. https://www.510kdatabase.net/k051873/ 2005-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k051873-disposable-temperature-skin-and-fda-510k.jpg K051873 - DISPOSABLE TEMPERATURE, SKIN AND ESOPHAGEAL PROBES K051873 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ge Healthcare. Cleared Sep 2005. https://www.510kdatabase.net/k052412/ 2005-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k052412-innova-2100-iq-innova-3100-innova-3100-fda-510k.jpg K052412 - INNOVA 2100-IQ, INNOVA 3100, INNOVA 3100-IQ, INNOVA 4100, AND INNOVA 4100-IQ K052412 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Sep 2005. https://www.510kdatabase.net/k052345/ 2005-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k052345-advantage-sim-md-fda-510k.jpg K052345 - ADVANTAGE SIM MD K052345 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Sep 2005. https://www.510kdatabase.net/k050760/ 2005-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k050760-accu-chek-pocket-compass-diabetes-fda-510k.jpg K050760 - ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE K050760 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Sep 2005. https://www.510kdatabase.net/k051899/ 2005-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k051899-bd-pen-needle-fda-510k.jpg K051899 - BD PEN NEEDLE K051899 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson & CO. Cleared Sep 2005. https://www.510kdatabase.net/k052015/ 2005-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k052015-dimension-extended-range-cyclosporine-fda-510k.jpg K052015 - DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108 K052015 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Dade Behring, Inc.. Cleared Sep 2005. https://www.510kdatabase.net/k052224/ 2005-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k052224-bd-probe-tec-urine-preservative-fda-510k.jpg K052224 - BD PROBE TEC URINE PRESERVATIVE TRANSPORT K052224 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Sep 2005. https://www.510kdatabase.net/k052302/ 2005-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k052302-hemashield-platinum-woven-double-fda-510k.jpg K052302 - HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION K052302 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Sep 2005. https://www.510kdatabase.net/k051320/ 2005-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k051320-satellite-spinal-system-fda-510k.jpg K051320 - SATELLITE SPINAL SYSTEM K051320 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Sep 2005. https://www.510kdatabase.net/k051297/ 2005-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k051297-elecsys-n-mid-osteocalcin-elecsys-fda-510k.jpg K051297 - ELECSYS N-MID OSTEOCALCIN, ELECSYS OSTEOCALCIN CALSET, ELECSYS OSTEOCALCIN CALCHECK K051297 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Sep 2005. https://www.510kdatabase.net/k051650/ 2005-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k051650-stratus-cs-acute-care-mb-isoenzyme-of-fda-510k.jpg K051650 - STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK K051650 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Sep 2005. https://www.510kdatabase.net/k051986/ 2005-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k051986-synthes-45-mm-lcp-straight-fda-510k.jpg K051986 - SYNTHES 4.5 MM LCP STRAIGHT RECONSTRUCTION PLATES K051986 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Sep 2005. https://www.510kdatabase.net/k052167/ 2005-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k052167-datex-ohmeda-s5-tonometry-module-e-fda-510k.jpg K052167 - DATEX-OHMEDA S/5 TONOMETRY MODULE, E TONO AND ACCESSORIES K052167 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Ge Healthcare. Cleared Sep 2005. https://www.510kdatabase.net/k052305/ 2005-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k052305-mri-soft-tissue-motion-correction-fda-510k.jpg K052305 - MRI SOFT TISSUE MOTION CORRECTION SOFTWARE VA10A K052305 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 2005. https://www.510kdatabase.net/k052159/ 2005-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k052159-aida-compact-ii-system-fda-510k.jpg K052159 - AIDA COMPACT II SYSTEM K052159 is a FDA 510(k) cleared radiology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Sep 2005. https://www.510kdatabase.net/k051556/ 2005-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k051556-acumatch-a-series-connexion-gxl-fda-510k.jpg K051556 - ACUMATCH A-SERIES CONNEXION GXL ENHANCED CROSSLINKED POLYTHYLENE K051556 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Sep 2005. https://www.510kdatabase.net/k051975/ 2005-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k051975-porous-coated-discovery-elbow-fda-510k.jpg K051975 - POROUS COATED DISCOVERY ELBOW K051975 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Sep 2005. https://www.510kdatabase.net/k052185/ 2005-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k052185-destination-carotid-guiding-sheath-fda-510k.jpg K052185 - DESTINATION CAROTID GUIDING SHEATH K052185 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Sep 2005. https://www.510kdatabase.net/k042782/ 2005-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k042782-seer-mc-fda-510k.jpg K042782 - SEER MC K042782 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Sep 2005. https://www.510kdatabase.net/k050411/ 2005-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k050411-zimmer-ats-3000-automatic-tourniquet-fda-510k.jpg K050411 - ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM K050411 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Zimmer, Inc.. Cleared Sep 2005. https://www.510kdatabase.net/k050863/ 2005-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k050863-imager-ii-angiographic-catheter-fda-510k.jpg K050863 - IMAGER II ANGIOGRAPHIC CATHETER K050863 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Sep 2005. https://www.510kdatabase.net/k051592/ 2005-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k051592-modification-to-accu-chek-go-system-fda-510k.jpg K051592 - MODIFICATION TO ACCU-CHEK GO SYSTEM K051592 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Sep 2005. https://www.510kdatabase.net/k052149/ 2005-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k052149-edwards-peripheral-dilation-catheter-fda-510k.jpg K052149 - EDWARDS PERIPHERAL DILATION CATHETER K052149 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Sep 2005. https://www.510kdatabase.net/k052334/ 2005-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k052334-cavitron-rf-ultrasonic-scaler-system-fda-510k.jpg K052334 - CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131 K052334 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Sep 2005. https://www.510kdatabase.net/k052017/ 2005-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k052017-cyclosporine-extended-range-assay-csae-fda-510k.jpg K052017 - CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108 K052017 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Dade Behring, Inc.. Cleared Sep 2005. https://www.510kdatabase.net/k052144/ 2005-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k052144-tsrh-spinal-system-fda-510k.jpg K052144 - TSRH SPINAL SYSTEM K052144 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Aug 2005. https://www.510kdatabase.net/k051380/ 2005-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k051380-triathlon-press-fit-total-knee-system-fda-510k.jpg K051380 - TRIATHLON PRESS-FIT TOTAL KNEE SYSTEM K051380 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Aug 2005. https://www.510kdatabase.net/k050558/ 2005-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k050558-modification-to-recovery-filter-system-fda-510k.jpg K050558 - MODIFICATION TO: RECOVERY FILTER SYSTEM, MODEL RF-210F K050558 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Aug 2005. https://www.510kdatabase.net/k052101/ 2005-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k052101-cfas-calibrator-for-automated-systems-fda-510k.jpg K052101 - C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C K052101 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Aug 2005. https://www.510kdatabase.net/k051962/ 2005-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k051962-ultra-hdl-fda-510k.jpg K051962 - ULTRA HDL K051962 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Aug 2005. https://www.510kdatabase.net/k052036/ 2005-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k052036-atb-advance-pta-dilatation-catheter-fda-510k.jpg K052036 - ATB ADVANCE PTA DILATATION CATHETER K052036 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Aug 2005. https://www.510kdatabase.net/k052132/ 2005-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k052132-modification-to-lifestent-valeo-fda-510k.jpg K052132 - MODIFICATION TO: LIFESTENT VALEO BILIARY STENT SYSTEM K052132 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Aug 2005. https://www.510kdatabase.net/k052194/ 2005-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k052194-spyglass-direct-visualization-probe-fda-510k.jpg K052194 - SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR K052194 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Aug 2005. https://www.510kdatabase.net/k051376/ 2005-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k051376-accuchek-instant-plus-dual-testing-fda-510k.jpg K051376 - ACCUCHEK INSTANT PLUS DUAL TESTING SYSTEM, ACCUCHEK INSTANT PLUS CHOLESTEROL, ACCUCHEK INSTANT PLUS GLUCOCOSE K051376 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Aug 2005. https://www.510kdatabase.net/k051785/ 2005-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k051785-formula-418-biliary-stent-fda-510k.jpg K051785 - FORMULA 418 BILIARY STENT K051785 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook, Inc.. Cleared Aug 2005. https://www.510kdatabase.net/k052145/ 2005-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k052145-datex-ohmeda-s5-bis-module-e-bis-and-fda-510k.jpg K052145 - DATEX-OHMEDA S/5 BIS MODULE, E-BIS AND ACCESSORIES K052145 is a FDA 510(k) cleared neurology medical device. Manufacturer: Ge Healthcare. Cleared Aug 2005. https://www.510kdatabase.net/k052180/ 2005-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k052180-modification-to-vertex-reconstruction-fda-510k.jpg K052180 - MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM K052180 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Aug 2005. https://www.510kdatabase.net/k051564/ 2005-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k051564-olympus-crp-latex-reagent-osr6199-fda-510k.jpg K051564 - OLYMPUS CRP LATEX REAGENT, OSR6199 K051564 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus America, Inc.. Cleared Aug 2005. https://www.510kdatabase.net/k051995/ 2005-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k051995-profemur-renaissance-hip-stem-fda-510k.jpg K051995 - PROFEMUR RENAISSANCE HIP STEM K051995 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Aug 2005. https://www.510kdatabase.net/k052002/ 2005-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k052002-iron-standard-fda-510k.jpg K052002 - IRON STANDARD K052002 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Aug 2005. https://www.510kdatabase.net/k052187/ 2005-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k052187-modification-to-cd-horizon-spinal-system-fda-510k.jpg K052187 - MODIFICATION TO: CD HORIZON SPINAL SYSTEM K052187 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Aug 2005. https://www.510kdatabase.net/k051348/ 2005-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k051348-conserve-total-femoral-head-fda-510k.jpg K051348 - CONSERVE TOTAL FEMORAL HEAD K051348 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Aug 2005. https://www.510kdatabase.net/k052082/ 2005-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k052082-ferritin-on-the-access-immunoassay-fda-510k.jpg K052082 - FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020 K052082 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Aug 2005. https://www.510kdatabase.net/k051178/ 2005-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k051178-mee-1000a-neuromaster-fda-510k.jpg K051178 - MEE-1000A NEUROMASTER K051178 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Aug 2005. https://www.510kdatabase.net/k051597/ 2005-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k051597-stratus-cs-d-dimer-fda-510k.jpg K051597 - STRATUS CS D-DIMER K051597 is a FDA 510(k) cleared hematology medical device. Manufacturer: Dade Behring, Inc.. Cleared Aug 2005. https://www.510kdatabase.net/k052021/ 2005-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k052021-v5ms-transducer-and-mpt7-4-multiplane-fda-510k.jpg K052021 - V5MS TRANSDUCER AND MPT7-4 MULTIPLANE TRANSESOPHAGEAL TRANSDUCER K052021 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 2005. https://www.510kdatabase.net/k052069/ 2005-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k052069-protex-stabilization-system-with-fda-510k.jpg K052069 - PROTEX STABILIZATION SYSTEM WITH ADDITIONAL COMPONENTES K052069 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Aug 2005. https://www.510kdatabase.net/k050222/ 2005-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k050222-vanguard-anterior-stabilized-tibial-fda-510k.jpg K050222 - VANGUARD ANTERIOR STABILIZED TIBIAL BEARINGS K050222 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Aug 2005. https://www.510kdatabase.net/k051849/ 2005-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k051849-vitek-2-gram-positive-ertapenem-for-fda-510k.jpg K051849 - VITEK 2 GRAM POSITIVE ERTAPENEM FOR STREPTOCOCCUS PNEUMONIAE K051849 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Aug 2005. https://www.510kdatabase.net/k052034/ 2005-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k052034-terumo-syringe-withwithout-needle-fda-510k.jpg K052034 - TERUMO SYRINGE WITH/WITHOUT NEEDLE K052034 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terumo Medical Corp.. Cleared Aug 2005. https://www.510kdatabase.net/k052038/ 2005-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k052038-peripheral-cutting-balloon-small-fda-510k.jpg K052038 - PERIPHERAL CUTTING BALLOON SMALL MONORAIL OR OVER-THE-WIRE DELIVERY SYSTEM K052038 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corporation. Cleared Aug 2005. https://www.510kdatabase.net/k052054/ 2005-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k052054-tsrh-spinal-system-fda-510k.jpg K052054 - TSRH SPINAL SYSTEM K052054 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Aug 2005. https://www.510kdatabase.net/k052128/ 2005-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k052128-3m-attest-293-auto-reader-3m-attest-fda-510k.jpg K052128 - 3M ATTEST 293 AUTO-READER, 3M ATTEST 293G AUTO-READER K052128 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Aug 2005. https://www.510kdatabase.net/k051302/ 2005-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k051302-excel-bariatric-or-excel-shuttle-fda-510k.jpg K051302 - EXCEL BARIATRIC OR EXCEL SHUTTLE WHEELCHAIR K051302 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Medline Industries, Inc.. Cleared Aug 2005. https://www.510kdatabase.net/k051972/ 2005-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k051972-karl-storz-trans-nasal-esophagoscope-fda-510k.jpg K051972 - KARL STORZ TRANS-NASAL ESOPHAGOSCOPE K051972 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Aug 2005. https://www.510kdatabase.net/k051370/ 2005-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k051370-sterile-saline-for-device-care-sterile-fda-510k.jpg K051370 - STERILE SALINE FOR DEVICE CARE, STERILE WATER FOR DEVICE CARE, MODELS 2F7121, 2F8014 K051370 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Aug 2005. https://www.510kdatabase.net/k051748/ 2005-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k051748-hemoglide-series-and-hemoglide-star-fda-510k.jpg K051748 - HEMOGLIDE SERIES AND HEMOGLIDE STAR SERIES XK LONG-TERM HEMODIALYSIS CATHETERS K051748 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Aug 2005. https://www.510kdatabase.net/k051897/ 2005-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k051897-trio-monitor-fda-510k.jpg K051897 - TRIO MONITOR K051897 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Aug 2005. https://www.510kdatabase.net/k051505/ 2005-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k051505-scbsteris-or-light-interface-box-fda-510k.jpg K051505 - SCB/STERIS OR-LIGHT INTERFACE BOX K051505 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Aug 2005. https://www.510kdatabase.net/k051908/ 2005-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k051908-charlotte-compression-plate-fda-510k.jpg K051908 - CHARLOTTE COMPRESSION PLATE K051908 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Aug 2005. https://www.510kdatabase.net/k051732/ 2005-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k051732-endoscopic-applicator-fda-510k.jpg K051732 - ENDOSCOPIC APPLICATOR K051732 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Aug 2005. https://www.510kdatabase.net/k051967/ 2005-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k051967-revolution-xrd-digital-radiographic-fda-510k.jpg K051967 - REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS K051967 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Aug 2005. https://www.510kdatabase.net/k052053/ 2005-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k052053-liquichek-qualitative-urine-toxicology-fda-510k.jpg K052053 - LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, POSITIVE, MINIPAK K052053 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bio-Rad. Cleared Aug 2005. https://www.510kdatabase.net/k052113/ 2005-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k052113-dp-6600-ultrasonic-diagnostic-imaging-fda-510k.jpg K052113 - DP-6600 ULTRASONIC DIAGNOSTIC IMAGING SYSTEM K052113 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Aug 2005. https://www.510kdatabase.net/k040627/ 2005-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k040627-depuy-asr-modular-acetabular-cup-system-fda-510k.jpg K040627 - DEPUY ASR MODULAR ACETABULAR CUP SYSTEM K040627 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Aug 2005. https://www.510kdatabase.net/k043547/ 2005-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k043547-compress-segmental-femoral-replacement-fda-510k.jpg K043547 - COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM K043547 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Aug 2005. https://www.510kdatabase.net/k051385/ 2005-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k051385-explor-modular-radial-head-replacement-fda-510k.jpg K051385 - EXPLOR MODULAR RADIAL HEAD REPLACEMENT DEVICE K051385 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Aug 2005. https://www.510kdatabase.net/k051570/ 2005-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k051570-avl-hinge-knee-system-fda-510k.jpg K051570 - AVL HINGE KNEE SYSTEM K051570 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Aug 2005. https://www.510kdatabase.net/k051689/ 2005-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k051689-bd-phoenix-automated-microbiology-fda-510k.jpg K051689 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - DAPTOMYCIN 0.125 - 32 UG/ML K051689 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Aug 2005. https://www.510kdatabase.net/k051846/ 2005-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k051846-7f-sherpa-nx-guide-catheter-fda-510k.jpg K051846 - 7F SHERPA NX GUIDE CATHETER K051846 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Aug 2005. https://www.510kdatabase.net/k051883/ 2005-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k051883-datex-ohmeda-s5-eeg-module-e-eeg-and-fda-510k.jpg K051883 - DATEX-OHMEDA S/5 EEG MODULE, E-EEG AND DATEX-OHMEDA S/5 EEG HEADBOX, N-EEG AND ACCESSORIES. K051883 is a FDA 510(k) cleared neurology medical device. Manufacturer: Ge Healthcare. Cleared Aug 2005. https://www.510kdatabase.net/k051884/ 2005-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k051884-charlotte-small-mtp-fusion-plate-fda-510k.jpg K051884 - CHARLOTTE SMALL MTP FUSION PLATE K051884 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Aug 2005. https://www.510kdatabase.net/k052037/ 2005-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k052037-modification-to-hoffmann-ii-micro-fda-510k.jpg K052037 - MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM K052037 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Aug 2005. https://www.510kdatabase.net/k051496/ 2005-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k051496-cobalt-bone-cement-fda-510k.jpg K051496 - COBALT BONE CEMENT K051496 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Aug 2005. https://www.510kdatabase.net/k051601/ 2005-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k051601-pinnacle-destination-peripheral-fda-510k.jpg K051601 - PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH K051601 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Aug 2005. https://www.510kdatabase.net/k051890/ 2005-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k051890-roche-diagnostics-cobas-elecsys-anti-tpo-fda-510k.jpg K051890 - ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO K051890 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Aug 2005. https://www.510kdatabase.net/k051327/ 2005-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k051327-abbott-axsym-b12-fda-510k.jpg K051327 - ABBOTT AXSYM B12 K051327 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Aug 2005. https://www.510kdatabase.net/k051532/ 2005-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k051532-cobalt-g-hv-bone-cement-fda-510k.jpg K051532 - COBALT G HV BONE CEMENT K051532 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Aug 2005. https://www.510kdatabase.net/k051122/ 2005-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k051122-itag-mhc-tetramer-cmv-assay-fda-510k.jpg K051122 - ITAG MHC TETRAMER CMV ASSAY K051122 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Aug 2005. https://www.510kdatabase.net/k051590/ 2005-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k051590-t2-ankle-arthrodesis-nail-fda-510k.jpg K051590 - T2 ANKLE ARTHRODESIS NAIL K051590 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jul 2005. https://www.510kdatabase.net/k050979/ 2005-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k050979-s4-spinal-system-fda-510k.jpg K050979 - S4 SPINAL SYSTEM K050979 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aesculap, Inc.. Cleared Jul 2005. https://www.510kdatabase.net/k051478/ 2005-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k051478-microscan-synergies-plus-gram-positive-fda-510k.jpg K051478 - MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS - RIFAMPIN K051478 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Jul 2005. https://www.510kdatabase.net/k051516/ 2005-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k051516-trabecular-metal-revision-shell-liners-fda-510k.jpg K051516 - TRABECULAR METAL REVISION SHELL LINERS K051516 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jul 2005. https://www.510kdatabase.net/k051600/ 2005-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k051600-synthes-usa-distraction-osteogenesis-fda-510k.jpg K051600 - SYNTHES (USA) DISTRACTION OSTEOGENESIS SYSTEM K051600 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jul 2005. https://www.510kdatabase.net/k051310/ 2005-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k051310-plc-screw-fda-510k.jpg K051310 - PLC SCREW K051310 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 2005. https://www.510kdatabase.net/k051194/ 2005-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k051194-bd-onecath-peripherally-inserted-fda-510k.jpg K051194 - BD ONECATH PERIPHERALLY INSERTED CENTRAL CATHETER, MODELS 384647, 384667, 384687, 384648, 384668, 384688, 384649, 384669 K051194 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson & CO. Cleared Jul 2005. https://www.510kdatabase.net/k051350/ 2005-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k051350-synergies-plus-gram-positive-miccombo-fda-510k.jpg K051350 - SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS K051350 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Jul 2005. https://www.510kdatabase.net/k051687/ 2005-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k051687-elecsys-precicontrol-universal-fda-510k.jpg K051687 - ELECSYS PRECICONTROL UNIVERSAL K051687 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jul 2005. https://www.510kdatabase.net/k051720/ 2005-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k051720-synthes-usa-bone-marrow-aspiration-fda-510k.jpg K051720 - SYNTHES (USA) BONE MARROW ASPIRATION SYRINGE K051720 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Synthes (Usa). Cleared Jul 2005. https://www.510kdatabase.net/k051790/ 2005-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k051790-3m-littmann-electronic-stethoscope-fda-510k.jpg K051790 - 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 4100 K051790 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: 3M Company. Cleared Jul 2005. https://www.510kdatabase.net/k041849/ 2005-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k041849-turbo-flo-picc-fda-510k.jpg K041849 - TURBO-FLO PICC K041849 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cook, Inc.. Cleared Jul 2005. https://www.510kdatabase.net/k050391/ 2005-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k050391-protex-ct-cervicothoracic-spinal-system-fda-510k.jpg K050391 - PROTEX CT CERVICOTHORACIC SPINAL SYSTEM K050391 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Jul 2005. https://www.510kdatabase.net/k051215/ 2005-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k051215-cell-dyn-sapphire-system-fda-510k.jpg K051215 - CELL-DYN SAPPHIRE SYSTEM K051215 is a FDA 510(k) cleared hematology medical device. Manufacturer: Abbott Laboratories. Cleared Jul 2005. https://www.510kdatabase.net/k051674/ 2005-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k051674-cd-horizon-spinal-system-fda-510k.jpg K051674 - CD HORIZON SPINAL SYSTEM K051674 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Jul 2005. https://www.510kdatabase.net/k051229/ 2005-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k051229-profix-flex-cruciate-retaining-fda-510k.jpg K051229 - PROFIX FLEX CRUCIATE RETAINING ARTICULAR INSERT K051229 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 2005. https://www.510kdatabase.net/k050210/ 2005-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k050210-disposable-cement-spacer-molds-for-fda-510k.jpg K050210 - DISPOSABLE CEMENT SPACER MOLDS FOR TEMPORARY KNEE PROSTHESES K050210 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jul 2005. https://www.510kdatabase.net/k051026/ 2005-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k051026-mars-holter-analysis-workstation-fda-510k.jpg K051026 - MARS HOLTER ANALYSIS WORKSTATION K051026 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Jul 2005. https://www.510kdatabase.net/k051634/ 2005-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k051634-datex-ohmeda-s5-device-interfacing-fda-510k.jpg K051634 - DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION K051634 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Healthcare. Cleared Jul 2005. https://www.510kdatabase.net/k051682/ 2005-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k051682-exactech-1214-alumina-femoral-heads-36-fda-510k.jpg K051682 - EXACTECH 12/14 ALUMINA FEMORAL HEADS 36 MM K051682 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Jul 2005. https://www.510kdatabase.net/k051735/ 2005-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k051735-peri-loc-locking-bone-plates-and-fda-510k.jpg K051735 - PERI-LOC LOCKING BONE PLATES AND LOCKING BONE SCREWS FOR THE UPPER EXTREMITY K051735 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 2005. https://www.510kdatabase.net/k051737/ 2005-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k051737-modification-to-v-40c-taper-adapter-fda-510k.jpg K051737 - MODIFICATION TO V-40/C-TAPER ADAPTER SLEEVE K051737 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jul 2005. https://www.510kdatabase.net/k051738/ 2005-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k051738-secur-fit-max-and-plus-max-hip-stems-fda-510k.jpg K051738 - SECUR-FIT MAX AND PLUS MAX HIP STEMS K051738 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jul 2005. https://www.510kdatabase.net/k050739/ 2005-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k050739-codman-vpv-system-model-82-3192-fda-510k.jpg K050739 - CODMAN VPV SYSTEM, MODEL 82-3192 K050739 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Jul 2005. https://www.510kdatabase.net/k051316/ 2005-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k051316-x-force-nephrostomy-balloon-dilation-fda-510k.jpg K051316 - X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER K051316 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jul 2005. https://www.510kdatabase.net/k051497/ 2005-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k051497-vitesse-20-fda-510k.jpg K051497 - VITESSE 2.0 K051497 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Jul 2005. https://www.510kdatabase.net/k051673/ 2005-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k051673-xeleris-2-processing-and-review-fda-510k.jpg K051673 - XELERIS 2 PROCESSING AND REVIEW WORKSTATION K051673 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Jul 2005. https://www.510kdatabase.net/k051253/ 2005-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k051253-modification-to-multirate-infusor-sv-fda-510k.jpg K051253 - MODIFICATION TO: MULTIRATE INFUSOR SV )WITH AND WITHOUT PCM), MULTIRATE INFUSOR LV (WITH AND WITHOUT PCM) K051253 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jul 2005. https://www.510kdatabase.net/k051635/ 2005-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k051635-datex-ohmeda-s5-neuromuscular-fda-510k.jpg K051635 - DATEX-OHMEDA S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT AND ACCESSORIES K051635 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Ge Healthcare. Cleared Jul 2005. https://www.510kdatabase.net/k051707/ 2005-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k051707-eclipse-bonding-agent-fda-510k.jpg K051707 - ECLIPSE BONDING AGENT K051707 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jul 2005. https://www.510kdatabase.net/k051833/ 2005-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k051833-tsx-101ah-aquilion-64-sp-ct-scanner-fda-510k.jpg K051833 - TSX-101A/H AQUILION 64 SP CT SCANNER K051833 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Jul 2005. https://www.510kdatabase.net/k051679/ 2005-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k051679-ilab-ultrasound-imaging-system-fda-510k.jpg K051679 - ILAB ULTRASOUND IMAGING SYSTEM K051679 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Jul 2005. https://www.510kdatabase.net/k051692/ 2005-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k051692-bd-phoenix-automated-microbiology-fda-510k.jpg K051692 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMOXICILLIN (STREP) 0.0313 - 32 UG/ML K051692 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Jul 2005. https://www.510kdatabase.net/k051763/ 2005-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k051763-qd-kneefoot-coil-model-mjqj-147a-fda-510k.jpg K051763 - QD KNEE/FOOT COIL, MODEL MJQJ-147A K051763 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Jul 2005. https://www.510kdatabase.net/k051049/ 2005-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k051049-synthes-usa-low-profile-wrist-fixator-fda-510k.jpg K051049 - SYNTHES (USA) LOW-PROFILE WRIST FIXATOR K051049 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jul 2005. https://www.510kdatabase.net/k051146/ 2005-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k051146-triathlon-knee-system-fda-510k.jpg K051146 - TRIATHLON KNEE SYSTEM K051146 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jul 2005. https://www.510kdatabase.net/k051124/ 2005-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k051124-zilver-635-biliary-stent-fda-510k.jpg K051124 - ZILVER 635 BILIARY STENT K051124 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook, Inc.. Cleared Jul 2005. https://www.510kdatabase.net/k051311/ 2005-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k051311-microscan-synergies-plus-gram-positive-fda-510k.jpg K051311 - MICROSCAN SYNERGIES PLUS GRAM POSITIVE MINIMUM INHIBITORY CONCENTRATION/COMBO PANELS - LEVOFLOXACIN K051311 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Jul 2005. https://www.510kdatabase.net/k051463/ 2005-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k051463-xeno-adhesive-with-activator-fda-510k.jpg K051463 - XENO ADHESIVE WITH ACTIVATOR K051463 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jul 2005. https://www.510kdatabase.net/k051588/ 2005-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k051588-biolox-delta-ceramic-femoral-heads-fda-510k.jpg K051588 - BIOLOX DELTA CERAMIC FEMORAL HEADS K051588 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jul 2005. https://www.510kdatabase.net/k050053/ 2005-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k050053-hemoramaggram-analyzer-fda-510k.jpg K050053 - HEMORAM/AGGRAM ANALYZER K050053 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Jul 2005. https://www.510kdatabase.net/k051087/ 2005-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k051087-dimension-vista-integrated-system-fda-510k.jpg K051087 - DIMENSION VISTA INTEGRATED SYSTEM K051087 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Jul 2005. https://www.510kdatabase.net/k051272/ 2005-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k051272-bd-phoenix-automated-microbiology-fda-510k.jpg K051272 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CLINDAMYCIN (STREP) 0.03125 -4 UG/ML K051272 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Jul 2005. https://www.510kdatabase.net/k051752/ 2005-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k051752-roche-elecsys-troponin-t-stat-short-fda-510k.jpg K051752 - ROCHE ELECSYS TROPONIN T STAT (SHORT TURNAROUND TIME) K051752 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Jul 2005. https://www.510kdatabase.net/k051518/ 2005-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k051518-unity-network-id-fda-510k.jpg K051518 - UNITY NETWORK ID K051518 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Jul 2005. https://www.510kdatabase.net/k042472/ 2005-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k042472-bd-directigen-ez-flu-a-b-fda-510k.jpg K042472 - BD DIRECTIGEN EZ FLU A + B K042472 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Jul 2005. https://www.510kdatabase.net/k051098/ 2005-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k051098-periarticular-locking-plates-and-fda-510k.jpg K051098 - PERIARTICULAR LOCKING PLATES AND SCREWS, MODEL 2358 SERIES K051098 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jul 2005. https://www.510kdatabase.net/k051624/ 2005-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k051624-t2-recon-nail-system-fda-510k.jpg K051624 - T2 RECON NAIL SYSTEM K051624 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jul 2005. https://www.510kdatabase.net/k050231/ 2005-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k050231-elecsys-ca-19-9-immunoassay-elecsys-ca-fda-510k.jpg K050231 - ELECSYS CA 19-9 IMMUNOASSAY, ELECSYS CA 19-9 CALSET K050231 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jul 2005. https://www.510kdatabase.net/k051185/ 2005-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k051185-elecsys-ca-19-9-calcheck-fda-510k.jpg K051185 - ELECSYS CA 19-9 CALCHECK K051185 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jul 2005. https://www.510kdatabase.net/k051266/ 2005-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k051266-bd-phoenix-automated-microbiology-fda-510k.jpg K051266 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - LINEZOLID (STREP) 0.25 - 16UG/ML K051266 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Jul 2005. https://www.510kdatabase.net/k051517/ 2005-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k051517-elecsys-precicontrol-anemia-fda-510k.jpg K051517 - ELECSYS PRECICONTROL ANEMIA K051517 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jul 2005. https://www.510kdatabase.net/k051136/ 2005-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k051136-smith-nephew-cds-system-fda-510k.jpg K051136 - SMITH & NEPHEW CDS SYSTEM K051136 is a FDA 510(k) cleared radiology medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 2005. https://www.510kdatabase.net/k051541/ 2005-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k051541-gf-ue160-al5-ultrasound-endoscope-fda-510k.jpg K051541 - GF-UE160-AL5 ULTRASOUND ENDOSCOPE K051541 is a FDA 510(k) cleared radiology medical device. Manufacturer: Olympus America, Inc.. Cleared Jul 2005. https://www.510kdatabase.net/k051417/ 2005-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k051417-6-fr-fl-powerhohn-and-powerline-catheter-fda-510k.jpg K051417 - 6 FR FL POWERHOHN AND POWERLINE CATHETER K051417 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jun 2005. https://www.510kdatabase.net/k051491/ 2005-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k051491-trabecular-metal-primary-hip-prosthesis-fda-510k.jpg K051491 - TRABECULAR METAL PRIMARY HIP PROSTHESIS K051491 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jun 2005. https://www.510kdatabase.net/k051557/ 2005-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k051557-trigen-retrograde-femoral-fda-510k.jpg K051557 - TRIGEN RETROGRADE FEMORAL, SUPRACONDYLAR AND TIBIAL NAILS K051557 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jun 2005. https://www.510kdatabase.net/k050441/ 2005-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k050441-taper-2-porous-femoral-stem-fda-510k.jpg K050441 - TAPER 2 POROUS FEMORAL STEM K050441 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jun 2005. https://www.510kdatabase.net/k050802/ 2005-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k050802-modification-to-intuitive-surgical-da-fda-510k.jpg K050802 - MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS K050802 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Jun 2005. https://www.510kdatabase.net/k050845/ 2005-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k050845-monocryl-plus-antibacterial-suture-fda-510k.jpg K050845 - MONOCRYL PLUS ANTIBACTERIAL SUTURE K050845 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Jun 2005. https://www.510kdatabase.net/k050928/ 2005-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k050928-dade-thrombin-reagent-fda-510k.jpg K050928 - DADE THROMBIN REAGENT K050928 is a FDA 510(k) cleared hematology medical device. Manufacturer: Dade Behring, Inc.. Cleared Jun 2005. https://www.510kdatabase.net/k051219/ 2005-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k051219-pushlock-fda-510k.jpg K051219 - PUSHLOCK K051219 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jun 2005. https://www.510kdatabase.net/k051411/ 2005-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k051411-arcomxl-polyethylene-liners-and-biolox-fda-510k.jpg K051411 - ARCOMXL POLYETHYLENE LINERS AND BIOLOX DELTA HEADS K051411 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jun 2005. https://www.510kdatabase.net/k051204/ 2005-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k051204-bd-phoenix-automated-microbiology-fda-510k.jpg K051204 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFEPIME (STREP) 0.0625-4UG/ML K051204 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Jun 2005. https://www.510kdatabase.net/k051462/ 2005-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k051462-modification-to-cercon-base-fda-510k.jpg K051462 - MODIFICATION TO: CERCON BASE K051462 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jun 2005. https://www.510kdatabase.net/k051202/ 2005-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k051202-dried-gram-positive-miccombo-panels-fda-510k.jpg K051202 - DRIED GRAM-POSITIVE MIC/COMBO PANELS K051202 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Jun 2005. https://www.510kdatabase.net/k051363/ 2005-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k051363-restoration-modular-system-fda-510k.jpg K051363 - RESTORATION MODULAR SYSTEM K051363 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jun 2005. https://www.510kdatabase.net/k050583/ 2005-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k050583-model-250-series-maternalfetal-monitor-fda-510k.jpg K050583 - MODEL 250 SERIES MATERNAL/FETAL MONITOR K050583 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Jun 2005. https://www.510kdatabase.net/k051183/ 2005-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k051183-bd-phoenix-automated-microbiology-fda-510k.jpg K051183 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - GATIFLOXACIN (STREP) 0.0625 -8UG/ML K051183 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Jun 2005. https://www.510kdatabase.net/k051335/ 2005-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k051335-acumatch-1214-press-fit-femoral-stems-fda-510k.jpg K051335 - ACUMATCH 12/14 PRESS-FIT FEMORAL STEMS K051335 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Jun 2005. https://www.510kdatabase.net/k051483/ 2005-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k051483-kodak-directview-dr-system-detector-fda-510k.jpg K051483 - KODAK DIRECTVIEW DR SYSTEM DETECTOR K051483 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Jun 2005. https://www.510kdatabase.net/k051367/ 2005-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k051367-patient-monitor-models-dash-3000-4000-fda-510k.jpg K051367 - PATIENT MONITOR, MODELS DASH 3000, 4000 AND 5000 K051367 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Jun 2005. https://www.510kdatabase.net/k051292/ 2005-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k051292-elecsys-rbc-folate-hemolyzed-reagent-fda-510k.jpg K051292 - ELECSYS RBC FOLATE HEMOLYZED REAGENT K051292 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jun 2005. https://www.510kdatabase.net/k051306/ 2005-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k051306-hoffmann-ii-mri-external-fixation-system-fda-510k.jpg K051306 - HOFFMANN II MRI EXTERNAL FIXATION SYSTEM K051306 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jun 2005. https://www.510kdatabase.net/k051500/ 2005-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k051500-famio-diagnostic-ultrasound-systems-fda-510k.jpg K051500 - FAMIO DIAGNOSTIC ULTRASOUND SYSTEMS, MODEL SSA-530A K051500 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Jun 2005. https://www.510kdatabase.net/k051361/ 2005-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k051361-easy-core-detachable-biopsy-system-fda-510k.jpg K051361 - EASY CORE DETACHABLE BIOPSY SYSTEM K051361 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Jun 2005. https://www.510kdatabase.net/k051449/ 2005-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k051449-ge-vivid-7-with-or-without-suffix-fda-510k.jpg K051449 - GE VIVID 7 WITH OR WITHOUT SUFFIX K051449 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Jun 2005. https://www.510kdatabase.net/k051504/ 2005-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k051504-spyscope-access-and-delivery-catheter-fda-510k.jpg K051504 - SPYSCOPE ACCESS AND DELIVERY CATHETER K051504 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Jun 2005. https://www.510kdatabase.net/k050759/ 2005-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k050759-bipap-auto-fda-510k.jpg K050759 - BIPAP AUTO K050759 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Jun 2005. https://www.510kdatabase.net/k050931/ 2005-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k050931-6-fr-dl-powerpicc-catheter-fda-510k.jpg K050931 - 6 FR DL POWERPICC CATHETER K050931 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jun 2005. https://www.510kdatabase.net/k051109/ 2005-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k051109-bd-phoenix-automated-microbiology-fda-510k.jpg K051109 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN (STREP) 0.0156 - 4UG/ML K051109 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Jun 2005. https://www.510kdatabase.net/k051267/ 2005-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k051267-gore-resolut-regenerative-material-fda-510k.jpg K051267 - GORE RESOLUT REGENERATIVE MATERIAL, GORE RESOLUT XT REGENERATIVE MEMBRANE, GORE OSSEOQUEST REGENERATIVE MEMBRANE K051267 is a FDA 510(k) cleared dental medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Jun 2005. https://www.510kdatabase.net/k051326/ 2005-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k051326-smith-nephew-25-fluid-management-system-fda-510k.jpg K051326 - SMITH & NEPHEW 25 FLUID MANAGEMENT SYSTEM K051326 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jun 2005. https://www.510kdatabase.net/k050809/ 2005-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k050809-cd-horizon-spinal-system-fda-510k.jpg K050809 - CD HORIZON SPINAL SYSTEM K050809 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Jun 2005. https://www.510kdatabase.net/k050662/ 2005-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k050662-quanta-lite-sp100-elisa-fda-510k.jpg K050662 - QUANTA LITE SP100 ELISA K050662 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Jun 2005. https://www.510kdatabase.net/k051307/ 2005-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k051307-synchron-systems-bebzodiazapine-ebnz-fda-510k.jpg K051307 - SYNCHRON SYSTEMS BEBZODIAZAPINE (EBNZ) REAGENT K051307 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jun 2005. https://www.510kdatabase.net/k042164/ 2005-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k042164-silver-antimicrobial-wound-gauze-sponge-fda-510k.jpg K042164 - SILVER ANTIMICROBIAL WOUND GAUZE (SPONGE) K042164 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medline Industries, Inc.. Cleared Jun 2005. https://www.510kdatabase.net/k051105/ 2005-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k051105-basis-vertebral-body-spacer-fda-510k.jpg K051105 - BASIS VERTEBRAL BODY SPACER K051105 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Jun 2005. https://www.510kdatabase.net/k051125/ 2005-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k051125-ivs-clip-closure-system-model-1002-ivs-fda-510k.jpg K051125 - IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER), 14677 K051125 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Abbott Laboratories. Cleared Jun 2005. https://www.510kdatabase.net/k051179/ 2005-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k051179-ez-plus-retrieval-sheath-model-38899-150-fda-510k.jpg K051179 - EZ PLUS RETRIEVAL SHEATH, MODEL 38899-150 K051179 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Jun 2005. https://www.510kdatabase.net/k050599/ 2005-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k050599-tracker-excel-14-pre-shaped-fda-510k.jpg K050599 - TRACKER EXCEL -14 PRE-SHAPED MICROCATHETER K050599 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Jun 2005. https://www.510kdatabase.net/k051138/ 2005-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k051138-bd-phoenix-automated-microbiology-fda-510k.jpg K051138 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTRIAXONE (STREP) 0.0625 - 4UG/ML K051138 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Jun 2005. https://www.510kdatabase.net/k050947/ 2005-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k050947-modification-to-modified-uss-fda-510k.jpg K050947 - MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE K050947 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Jun 2005. https://www.510kdatabase.net/k051133/ 2005-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k051133-arcadis-avantic-fda-510k.jpg K051133 - ARCADIS AVANTIC K051133 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 2005. https://www.510kdatabase.net/k051258/ 2005-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k051258-kodak-directview-dr-7500-system-model-fda-510k.jpg K051258 - KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345 K051258 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Jun 2005. https://www.510kdatabase.net/k051086/ 2005-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k051086-smith-nephew-patello-femoral-implant-fda-510k.jpg K051086 - SMITH & NEPHEW PATELLO-FEMORAL IMPLANT K051086 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared May 2005. https://www.510kdatabase.net/k042606/ 2005-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k042606-modification-tosynthes-usa-titanium-wire-fda-510k.jpg K042606 - MODIFICATION TO:SYNTHES (USA) TITANIUM WIRE K042606 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Synthes (Usa). Cleared May 2005. https://www.510kdatabase.net/k050006/ 2005-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k050006-borealis-amplifier-clearsign-model-fda-510k.jpg K050006 - BOREALIS AMPLIFIER (CLEARSIGN), MODEL 2001232 160 CHANNEL VERSION, 2001267 80 CHANNEL VERSION, 2001268 40 CHANNEL VERSIO K050006 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 2005. https://www.510kdatabase.net/k050251/ 2005-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k050251-balance-hip-system-fda-510k.jpg K050251 - BALANCE HIP SYSTEM K050251 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared May 2005. https://www.510kdatabase.net/k050259/ 2005-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k050259-arthrex-bio-pin-fda-510k.jpg K050259 - ARTHREX BIO-PIN K050259 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared May 2005. https://www.510kdatabase.net/k050946/ 2005-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k050946-bd-phoenix-automated-microbiology-fda-510k.jpg K050946 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM (STREP) 0.03125-2 UG/ML K050946 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared May 2005. https://www.510kdatabase.net/k050185/ 2005-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k050185-powerhohn-and-powerline-catheters-fda-510k.jpg K050185 - POWERHOHN AND POWERLINE CATHETERS K050185 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 2005. https://www.510kdatabase.net/k050850/ 2005-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k050850-xpand-corpectomy-spacer-fda-510k.jpg K050850 - XPAND CORPECTOMY SPACER K050850 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared May 2005. https://www.510kdatabase.net/k050875/ 2005-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k050875-u-balloon-dilation-catheter-fda-510k.jpg K050875 - U-BALLOON DILATION CATHETER K050875 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 2005. https://www.510kdatabase.net/k050389/ 2005-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k050389-ultra-soft-sv-balloon-dilatation-fda-510k.jpg K050389 - ULTRA-SOFT SV BALLOON DILATATION CATHETER K050389 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared May 2005. https://www.510kdatabase.net/k050898/ 2005-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k050898-smith-nephew-vulcan-articular-fda-510k.jpg K050898 - SMITH & NEPHEW VULCAN ARTICULAR CARTILAGE PROBE, MODEL 721XXXX K050898 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared May 2005. https://www.510kdatabase.net/k051092/ 2005-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k051092-datex-ohmeda-s5-compact-airway-module-fda-510k.jpg K051092 - DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE (MODEL FAMILY E-CAIOVX) E-CAIOVX, E-CAIOV, E-CAIO, E-COVX, E-COV, E-CO & ACCESACC K051092 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Ge Healthcare. Cleared May 2005. https://www.510kdatabase.net/k050982/ 2005-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k050982-bd-phonix-automated-microbiology-fda-510k.jpg K050982 - BD PHONIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOTAXIME STREP (0.0625-4UG/ML) K050982 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared May 2005. https://www.510kdatabase.net/k050943/ 2005-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k050943-ge-viewpoint-fda-510k.jpg K050943 - GE VIEWPOINT K050943 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared May 2005. https://www.510kdatabase.net/k050976/ 2005-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k050976-vitek-2-gram-positive-fda-510k.jpg K050976 - VITEK 2 GRAM POSITIVE TRIMETHOPRIM/SULFAMETHOXAZOLE K050976 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared May 2005. https://www.510kdatabase.net/k051170/ 2005-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k051170-gemini-gxl-fda-510k.jpg K051170 - GEMINI GXL K051170 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared May 2005. https://www.510kdatabase.net/k050534/ 2005-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k050534-xpert-self-expanding-transhepatic-fda-510k.jpg K050534 - XPERT SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM K050534 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Abbott Laboratories. Cleared May 2005. https://www.510kdatabase.net/k050684/ 2005-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k050684-atlantis-pv-fda-510k.jpg K050684 - ATLANTIS PV K050684 is a FDA 510(k) cleared radiology medical device. Manufacturer: Boston Scientific Corp. Cleared May 2005. https://www.510kdatabase.net/k050865/ 2005-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k050865-bd-phoenix-automated-microbiology-fda-510k.jpg K050865 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-TRIMETHOPRIM-SULFAMETHOXAZOLE 0.0625/1.2-16/304 UG/ML K050865 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared May 2005. https://www.510kdatabase.net/k050731/ 2005-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k050731-seer-light-extend-compact-digital-fda-510k.jpg K050731 - SEER LIGHT EXTEND COMPACT DIGITAL HOLTER SYSTEM K050731 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared May 2005. https://www.510kdatabase.net/k050608/ 2005-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k050608-synthes-carniofacial-plate-and-screw-fda-510k.jpg K050608 - SYNTHES CARNIOFACIAL PLATE AND SCREW SYSTEM K050608 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared May 2005. https://www.510kdatabase.net/k042543/ 2005-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k042543-iplan-digital-templating-fda-510k.jpg K042543 - IPLAN! DIGITAL TEMPLATING K042543 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared May 2005. https://www.510kdatabase.net/k050105/ 2005-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k050105-nexgen-complete-knee-solution-distal-fda-510k.jpg K050105 - NEXGEN COMPLETE KNEE SOLUTION DISTAL FEMORAL SPACERS K050105 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared May 2005. https://www.510kdatabase.net/k050981/ 2005-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k050981-cd-horizon-spinal-system-fda-510k.jpg K050981 - CD HORIZON SPINAL SYSTEM K050981 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared May 2005. https://www.510kdatabase.net/k050315/ 2005-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k050315-delta-humeral-cups-fda-510k.jpg K050315 - DELTA HUMERAL CUPS K050315 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared May 2005. https://www.510kdatabase.net/k050093/ 2005-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k050093-mac-labcardiolab-epcombolab-system-fda-510k.jpg K050093 - MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM K050093 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared May 2005. https://www.510kdatabase.net/k051139/ 2005-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k051139-acuson-sequoia-diagnostic-ultrasound-fda-510k.jpg K051139 - ACUSON SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM K051139 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 2005. https://www.510kdatabase.net/k050715/ 2005-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k050715-quanta-plex-anca-profile-fda-510k.jpg K050715 - QUANTA PLEX ANCA PROFILE K050715 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared May 2005. https://www.510kdatabase.net/k050749/ 2005-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k050749-arthrex-tak-family-fda-510k.jpg K050749 - ARTHREX TAK FAMILY K050749 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared May 2005. https://www.510kdatabase.net/k050780/ 2005-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k050780-bd-phoenixtm-automated-microbiology-fda-510k.jpg K050780 - BD PHOENIXTM AUTOMATED MICROBIOLOGY SYSTEM - PENICILLIN (STREP) 0.156 -32 UG/ML K050780 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared May 2005. https://www.510kdatabase.net/k050816/ 2005-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k050816-vitek-2-gram-positive-meropenem-fda-510k.jpg K050816 - VITEK 2 GRAM POSITIVE MEROPENEM K050816 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared May 2005. https://www.510kdatabase.net/k050881/ 2005-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k050881-bd-phoenix-automated-microbiology-fda-510k.jpg K050881 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TETRACYCLINE (STREP) 0.0625 - 16 UG/ML K050881 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared May 2005. https://www.510kdatabase.net/k051039/ 2005-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k051039-basis-spinal-system-fda-510k.jpg K051039 - BASIS SPINAL SYSTEM K051039 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared May 2005. https://www.510kdatabase.net/k050119/ 2005-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k050119-paragon-cze-2000-urine-protein-fda-510k.jpg K050119 - PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY SUBTRACTION KIT K050119 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared May 2005. https://www.510kdatabase.net/k050835/ 2005-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k050835-datex-ohmeda-s5tm-entropy-module-e-fda-510k.jpg K050835 - DATEX-OHMEDA S/5TM ENTROPY MODULE, E-ENTROPY AND ACCESSORIES K050835 is a FDA 510(k) cleared neurology medical device. Manufacturer: Ge Healthcare. Cleared May 2005. https://www.510kdatabase.net/k050962/ 2005-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k050962-merit-prelude-sheath-introducer-fda-510k.jpg K050962 - MERIT PRELUDE SHEATH INTRODUCER K050962 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared May 2005. https://www.510kdatabase.net/k043509/ 2005-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k043509-gunther-tulip-vena-cava-filter-set-fda-510k.jpg K043509 - GUNTHER TULIP VENA CAVA FILTER SET K043509 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared May 2005. https://www.510kdatabase.net/k043073/ 2005-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k043073-procotyl-e-acetabular-system-fda-510k.jpg K043073 - PROCOTYL-E ACETABULAR SYSTEM K043073 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared May 2005. https://www.510kdatabase.net/k050813/ 2005-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k050813-abc-2-screw-fda-510k.jpg K050813 - ABC 2 SCREW K050813 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aesculap, Inc.. Cleared May 2005. https://www.510kdatabase.net/k050849/ 2005-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k050849-ha-coated-lag-screw-fda-510k.jpg K050849 - HA COATED LAG SCREW K050849 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared May 2005. https://www.510kdatabase.net/k050938/ 2005-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k050938-knee-fusion-nail-fda-510k.jpg K050938 - KNEE FUSION NAIL K050938 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared May 2005. https://www.510kdatabase.net/k050661/ 2005-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k050661-hemosil-factor-ii-deficient-plasma-fda-510k.jpg K050661 - HEMOSIL FACTOR II DEFICIENT PLASMA K050661 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared May 2005. https://www.510kdatabase.net/k050665/ 2005-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k050665-n-antisera-to-human-complement-factors-fda-510k.jpg K050665 - N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4) K050665 is a FDA 510(k) cleared immunology medical device. Manufacturer: Dade Behring, Inc.. Cleared May 2005. https://www.510kdatabase.net/k050872/ 2005-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k050872-accu-chek-integra-system-fda-510k.jpg K050872 - ACCU-CHEK INTEGRA SYSTEM K050872 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared May 2005. https://www.510kdatabase.net/k042118/ 2005-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k042118-athena-multi-lyte-ebv-igg-test-system-fda-510k.jpg K042118 - ATHENA MULTI-LYTE EBV IGG TEST SYSTEM K042118 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Apr 2005. https://www.510kdatabase.net/k050369/ 2005-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k050369-intuitive-surgical-da-vinci-surgical-fda-510k.jpg K050369 - INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000 K050369 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Apr 2005. https://www.510kdatabase.net/k050745/ 2005-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k050745-bd-phoenix-automated-microbiology-fda-510k.jpg K050745 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, VANCOMYCIN (STREP) 0.0625 -32 UG/ML K050745 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Apr 2005. https://www.510kdatabase.net/k050747/ 2005-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k050747-bd-phoenix-automated-microbiology-fda-510k.jpg K050747 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, LEVOFLOXACIN (STREP) 0.25-16 UG/ML K050747 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Apr 2005. https://www.510kdatabase.net/k050833/ 2005-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k050833-electrode-junction-box-model-je-921a-fda-510k.jpg K050833 - ELECTRODE JUNCTION BOX, MODEL JE-921A K050833 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Apr 2005. https://www.510kdatabase.net/k042989/ 2005-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k042989-rx90-low-profile-acetabular-system-fda-510k.jpg K042989 - RX90 LOW PROFILE ACETABULAR SYSTEM K042989 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Apr 2005. https://www.510kdatabase.net/k043474/ 2005-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k043474-accu-chek-aviva-system-fda-510k.jpg K043474 - ACCU-CHEK AVIVA SYSTEM K043474 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Apr 2005. https://www.510kdatabase.net/k050537/ 2005-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k050537-liquichek-cardiac-markers-plus-control-fda-510k.jpg K050537 - LIQUICHEK CARDIAC MARKERS PLUS CONTROL, LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LIQUICHEK CARDIAC MARKERS PLUS K050537 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Apr 2005. https://www.510kdatabase.net/k050683/ 2005-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k050683-synthes-usa-35mm-conical-screws-fda-510k.jpg K050683 - SYNTHES (USA) 3.5MM CONICAL SCREWS K050683 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Apr 2005. https://www.510kdatabase.net/k050752/ 2005-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k050752-aesculap-orthopilot-2-tha-v-20-fda-510k.jpg K050752 - AESCULAP ORTHOPILOT 2 THA V 2.0 K050752 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Apr 2005. https://www.510kdatabase.net/k050837/ 2005-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k050837-reusable-temperature-probes-m1024254-fda-510k.jpg K050837 - REUSABLE TEMPERATURE PROBES (M1024254 SKIN TEMPERATURE PROBE, REUSABLE K050837 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ge Healthcare. Cleared Apr 2005. https://www.510kdatabase.net/k050544/ 2005-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k050544-hemosil-d-dimer-hs-fda-510k.jpg K050544 - HEMOSIL D-DIMER HS K050544 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Apr 2005. https://www.510kdatabase.net/k050646/ 2005-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k050646-synthes-usa-3545mm-lcp-medial-proximal-fda-510k.jpg K050646 - SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES K050646 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Apr 2005. https://www.510kdatabase.net/k050387/ 2005-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k050387-roche-diagnostics-elecsys-precicontrol-fda-510k.jpg K050387 - ROCHE DIAGNOSTICS ELECSYS PRECICONTROL TUMOR K050387 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Apr 2005. https://www.510kdatabase.net/k050423/ 2005-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k050423-omni-modular-omni-c-and-omni-s-fda-510k.jpg K050423 - OMNI MODULAR, OMNI C AND OMNI S ANALYZER (PH ELECTRODE) K050423 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Apr 2005. https://www.510kdatabase.net/k050880/ 2005-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k050880-dyract-extra-restorative-fda-510k.jpg K050880 - DYRACT EXTRA RESTORATIVE K050880 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Apr 2005. https://www.510kdatabase.net/k050030/ 2005-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k050030-acticoat-moisture-control-dressing-fda-510k.jpg K050030 - ACTICOAT MOISTURE CONTROL DRESSING K050030 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Apr 2005. https://www.510kdatabase.net/k050404/ 2005-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k050404-intuitive-surgical-da-vinci-surgical-fda-510k.jpg K050404 - INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS K050404 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Apr 2005. https://www.510kdatabase.net/k050636/ 2005-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k050636-synthes-30mm-headless-compression-screws-fda-510k.jpg K050636 - SYNTHES 3.0MM HEADLESS COMPRESSION SCREWS K050636 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Apr 2005. https://www.510kdatabase.net/k050723/ 2005-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k050723-mg-ii-total-knee-system-stemmed-tibial-fda-510k.jpg K050723 - MG II TOTAL KNEE SYSTEM STEMMED TIBIAL BASEPLATE COMPONENTS K050723 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Apr 2005. https://www.510kdatabase.net/k042721/ 2005-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k042721-kolibri-spine-fda-510k.jpg K042721 - KOLIBRI SPINE K042721 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Apr 2005. https://www.510kdatabase.net/k043083/ 2005-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k043083-advance-ha-coated-spiked-tibial-base-fda-510k.jpg K043083 - ADVANCE HA COATED SPIKED TIBIAL BASE AND ADVANCE HA COATED MODULAR KEEL K043083 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Apr 2005. https://www.510kdatabase.net/k050724/ 2005-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k050724-sure-point-midline-stepping-and-fda-510k.jpg K050724 - SURE-POINT MIDLINE STEPPING AND STABILIZATION SYSTEM K050724 is a FDA 510(k) cleared radiology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 2005. https://www.510kdatabase.net/k050358/ 2005-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k050358-artherx-corkscrew-ft-ii-suture-anchor-fda-510k.jpg K050358 - ARTHERX CORKSCREW FT II SUTURE ANCHOR K050358 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Apr 2005. https://www.510kdatabase.net/k050700/ 2005-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k050700-matrix-stretch-resistant-sr-coils-fda-510k.jpg K050700 - MATRIX STRETCH RESISTANT (SR) COILS K050700 is a FDA 510(k) cleared neurology medical device. Manufacturer: Boston Scientific Corp. Cleared Apr 2005. https://www.510kdatabase.net/k050555/ 2005-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k050555-bd-phoenix-automated-microbiology-fda-510k.jpg K050555 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFAZOLIN (GP) 2-32 UG/ML K050555 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Apr 2005. https://www.510kdatabase.net/k042092/ 2005-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k042092-athena-multi-lyte-ebv-vca-igm-test-fda-510k.jpg K042092 - ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM K042092 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Apr 2005. https://www.510kdatabase.net/k043555/ 2005-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k043555-synthes-9usa-alveolar-ridge-distractor-fda-510k.jpg K043555 - SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR K043555 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Apr 2005. https://www.510kdatabase.net/k043053/ 2005-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k043053-modification-to-cd-horizon-spinal-system-fda-510k.jpg K043053 - MODIFICATION TO CD HORIZON SPINAL SYSTEM K043053 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Apr 2005. https://www.510kdatabase.net/k050414/ 2005-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k050414-plix-fda-510k.jpg K050414 - PLIX K050414 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Apr 2005. https://www.510kdatabase.net/k050607/ 2005-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k050607-synthes-10mm-ti-cortex-self-drilling-fda-510k.jpg K050607 - SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (HAND & NEURO) K050607 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Apr 2005. https://www.510kdatabase.net/k050631/ 2005-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k050631-synthes-usa-small-adjustable-clamp-mr-fda-510k.jpg K050631 - SYNTHES (USA) SMALL ADJUSTABLE CLAMP-MR SAFE LINE EXTENSION K050631 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Apr 2005. https://www.510kdatabase.net/k050761/ 2005-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k050761-zimmer-trabecular-metal-humeral-stem-fda-510k.jpg K050761 - ZIMMER TRABECULAR METAL HUMERAL STEM, SIZES 6MM AND 8MM K050761 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Apr 2005. https://www.510kdatabase.net/k050804/ 2005-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k050804-modification-to-spectrumtm-cervical-fda-510k.jpg K050804 - MODIFICATION TO: SPECTRUMTM CERVICAL SPINAL SYSTEM K050804 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aesculap, Inc.. Cleared Apr 2005. https://www.510kdatabase.net/k050819/ 2005-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k050819-charlotte-snap-off-screw-fda-510k.jpg K050819 - CHARLOTTE SNAP-OFF SCREW K050819 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Apr 2005. https://www.510kdatabase.net/k043529/ 2005-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k043529-accu-chek-advisor-insulin-guidance-fda-510k.jpg K043529 - ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE K043529 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Apr 2005. https://www.510kdatabase.net/k050704/ 2005-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k050704-modification-to-revolution-xrd-digital-fda-510k.jpg K050704 - MODIFICATION TO: REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH IMAGE PASTING AND AUTOPOSITIONING K050704 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Apr 2005. https://www.510kdatabase.net/k050606/ 2005-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k050606-synthes-10mm-ti-cortex-self-drilling-fda-510k.jpg K050606 - SYNTHES 1.0MM TI. CORTEX, SELF-DRILLING SCREWS (CARNIOFACIAL) K050606 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Apr 2005. https://www.510kdatabase.net/k050688/ 2005-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k050688-tegress-implant-needle-fda-510k.jpg K050688 - TEGRESS IMPLANT NEEDLE K050688 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 2005. https://www.510kdatabase.net/k050750/ 2005-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k050750-lc-bracket-adhesive-system-fda-510k.jpg K050750 - LC BRACKET ADHESIVE SYSTEM K050750 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Apr 2005. https://www.510kdatabase.net/k050614/ 2005-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k050614-muse-cardiology-information-system-fda-510k.jpg K050614 - MUSE CARDIOLOGY INFORMATION SYSTEM K050614 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Apr 2005. https://www.510kdatabase.net/k043324/ 2005-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k043324-aida-with-dicom-and-hl7-interface-fda-510k.jpg K043324 - AIDA WITH DICOM AND HL7 INTERFACE K043324 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Apr 2005. https://www.510kdatabase.net/k050513/ 2005-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k050513-mda-b30-fda-510k.jpg K050513 - MDA B.30 K050513 is a FDA 510(k) cleared hematology medical device. Manufacturer: bioMerieux, Inc.. Cleared Apr 2005. https://www.510kdatabase.net/k050645/ 2005-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k050645-cordis-amiia-014-pta-balloon-catheter-fda-510k.jpg K050645 - CORDIS AMIIA .014 PTA BALLOON CATHETER K050645 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Apr 2005. https://www.510kdatabase.net/k050221/ 2005-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k050221-hemosil-silica-clotting-time-fda-510k.jpg K050221 - HEMOSIL SILICA CLOTTING TIME K050221 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Mar 2005. https://www.510kdatabase.net/k050577/ 2005-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k050577-atlantis-sr-pro2-coronary-imaging-fda-510k.jpg K050577 - ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014 K050577 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Mar 2005. https://www.510kdatabase.net/k050698/ 2005-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k050698-modification-tozilver-518-biliary-stent-fda-510k.jpg K050698 - MODIFICATION TO:ZILVER 518 BILIARY STENT K050698 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook, Inc.. Cleared Mar 2005. https://www.510kdatabase.net/k050043/ 2005-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k050043-microscan-dried-gram-positive-miccombo-fda-510k.jpg K050043 - MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN K050043 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Mar 2005. https://www.510kdatabase.net/k050539/ 2005-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k050539-size-1-triathlon-posterior-stabilized-fda-510k.jpg K050539 - SIZE 1 TRIATHLON POSTERIOR STABILIZED (PS) TIBIAL INSERT K050539 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Mar 2005. https://www.510kdatabase.net/k043556/ 2005-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k043556-synchron-systems-benzodiazepine-bnzg-fda-510k.jpg K043556 - SYNCHRON SYSTEMS BENZODIAZEPINE (BNZG) REAGENT K043556 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Mar 2005. https://www.510kdatabase.net/k042091/ 2005-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k042091-biolox-delta-ceramic-heads-fda-510k.jpg K042091 - BIOLOX DELTA CERAMIC HEADS K042091 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Mar 2005. https://www.510kdatabase.net/k050536/ 2005-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k050536-quest-diagnostics-immunoassaytdm-control-fda-510k.jpg K050536 - QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL K050536 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Mar 2005. https://www.510kdatabase.net/k050139/ 2005-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k050139-modification-to-export-catheter-fda-510k.jpg K050139 - MODIFICATION TO: EXPORT CATHETER K050139 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Mar 2005. https://www.510kdatabase.net/k050400/ 2005-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k050400-bd-phoenix-automated-microbiology-fda-510k.jpg K050400 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEPHALOTHIN (GP) 0.5-64 UG/ML K050400 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Mar 2005. https://www.510kdatabase.net/k050627/ 2005-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k050627-lifestent-turbo-biliary-stent-systems-fda-510k.jpg K050627 - LIFESTENT TURBO BILIARY STENT SYSTEMS K050627 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Mar 2005. https://www.510kdatabase.net/k043488/ 2005-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k043488-modification-to-cd-horizon-spinal-system-fda-510k.jpg K043488 - MODIFICATION TO CD HORIZON SPINAL SYSTEM K043488 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Mar 2005. https://www.510kdatabase.net/k050138/ 2005-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k050138-modification-to-restoration-modular-fda-510k.jpg K050138 - MODIFICATION TO: RESTORATION MODULAR SYSTEM K050138 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Mar 2005. https://www.510kdatabase.net/k050512/ 2005-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k050512-stryker-locked-plating-system-fda-510k.jpg K050512 - STRYKER LOCKED PLATING SYSTEM K050512 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Mar 2005. https://www.510kdatabase.net/k050634/ 2005-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k050634-modification-to-arthrex-v-tak-fda-510k.jpg K050634 - MODIFICATION TO: ARTHREX V-TAK K050634 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Mar 2005. https://www.510kdatabase.net/k042523/ 2005-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k042523-resection-pump-resectoscope-for-chip-fda-510k.jpg K042523 - RESECTION PUMP, RESECTOSCOPE FOR CHIP ASPIRATION, ENDOSCOPE 25/ 3.3 MM, ACCESSORIES K042523 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Mar 2005. https://www.510kdatabase.net/k050422/ 2005-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k050422-550-txt-treatment-table-fda-510k.jpg K050422 - 550 TXT TREATMENT TABLE K050422 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2005. https://www.510kdatabase.net/k050585/ 2005-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k050585-microscan-dried-gram-negative-miccombo-fda-510k.jpg K050585 - MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS AMOXICILLIN/K. CLAVULANATE K050585 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Mar 2005. https://www.510kdatabase.net/k050559/ 2005-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k050559-ge-discovery-vct-system-fda-510k.jpg K050559 - GE DISCOVERY VCT SYSTEM K050559 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Mar 2005. https://www.510kdatabase.net/k032666/ 2005-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k032666-medline-sterile-disposable-surgical-fda-510k.jpg K032666 - MEDLINE STERILE DISPOSABLE SURGICAL GOWNS/DRAPES K032666 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Mar 2005. https://www.510kdatabase.net/k042344/ 2005-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k042344-excia-total-hip-system-fda-510k.jpg K042344 - EXCIA TOTAL HIP SYSTEM K042344 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aesculap, Inc.. Cleared Mar 2005. https://www.510kdatabase.net/k042899/ 2005-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k042899-synthes-usa-ria-system-expanded-fda-510k.jpg K042899 - SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS K042899 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Mar 2005. https://www.510kdatabase.net/k043458/ 2005-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k043458-bd-phoenix-automated-microbiology-fda-510k.jpg K043458 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOTETAN (GN) 2-64 UG/ML K043458 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Mar 2005. https://www.510kdatabase.net/k050378/ 2005-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k050378-synthes-mandible-external-fixator-fda-510k.jpg K050378 - SYNTHES MANDIBLE EXTERNAL FIXATOR K050378 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Mar 2005. https://www.510kdatabase.net/k042515/ 2005-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k042515-smith-nephew-inc-high-performance-knee-fda-510k.jpg K042515 - SMITH & NEPHEW, INC. HIGH PERFORMANCE KNEE K042515 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Mar 2005. https://www.510kdatabase.net/k043058/ 2005-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k043058-pinnacle-constrained-acetabular-liners-fda-510k.jpg K043058 - PINNACLE CONSTRAINED ACETABULAR LINERS K043058 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Mar 2005. https://www.510kdatabase.net/k050361/ 2005-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k050361-modification-to-concerto-bipolar-fda-510k.jpg K050361 - MODIFICATION TO CONCERTO BIPOLAR NEEDLE ELECTRODE K050361 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Boston Scientific Corp. Cleared Mar 2005. https://www.510kdatabase.net/k041825/ 2005-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k041825-smith-nephew-genesis-ii-deep-flexion-fda-510k.jpg K041825 - SMITH & NEPHEW GENESIS II DEEP FLEXION CRUCIATE RETAINING ARTICULAR INSERT K041825 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Mar 2005. https://www.510kdatabase.net/k042956/ 2005-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k042956-vision-fda-510k.jpg K042956 - VISION K042956 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Mar 2005. https://www.510kdatabase.net/k043303/ 2005-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k043303-online-dat-propoxyphene-plus-fda-510k.jpg K043303 - ONLINE DAT PROPOXYPHENE PLUS K043303 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Mar 2005. https://www.510kdatabase.net/k050232/ 2005-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k050232-rigiflex-single-use-achalasia-balloon-fda-510k.jpg K050232 - RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR K050232 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Mar 2005. https://www.510kdatabase.net/k050278/ 2005-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k050278-hemosil-d-dimer-fda-510k.jpg K050278 - HEMOSIL D-DIMER K050278 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Mar 2005. https://www.510kdatabase.net/k050458/ 2005-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k050458-tsx-201a-aquilion-lb-ct-scanner-fda-510k.jpg K050458 - TSX-201A AQUILION LB CT SCANNER K050458 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Mar 2005. https://www.510kdatabase.net/k042051/ 2005-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k042051-arcomxl-polyethylene-liners-fda-510k.jpg K042051 - ARCOMXL POLYETHYLENE LINERS K042051 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Mar 2005. https://www.510kdatabase.net/k043017/ 2005-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k043017-prevention-breathable-impervious-fda-510k.jpg K043017 - PREVENTION BREATHABLE, IMPERVIOUS SURGICAL GOWNS K043017 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Mar 2005. https://www.510kdatabase.net/k043585/ 2005-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k043585-medline-surgical-gowns-fda-510k.jpg K043585 - MEDLINE SURGICAL GOWNS K043585 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Mar 2005. https://www.510kdatabase.net/k043101/ 2005-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k043101-nexgen-complete-knee-solution-mis-fda-510k.jpg K043101 - NEXGEN COMPLETE KNEE SOLUTION MIS TIBIAL COMPONENTS, LOCKING SCREW AND STEM EXTENSIONS K043101 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Mar 2005. https://www.510kdatabase.net/k043223/ 2005-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k043223-depuy-cas-knee-instrumentation-fda-510k.jpg K043223 - DEPUY CAS KNEE INSTRUMENTATION K043223 is a FDA 510(k) cleared neurology medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Mar 2005. https://www.510kdatabase.net/k050048/ 2005-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k050048-hoffman-ii-micro-external-fixation-fda-510k.jpg K050048 - HOFFMAN II MICRO EXTERNAL FIXATION SYSTEM K050048 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Mar 2005. https://www.510kdatabase.net/k050110/ 2005-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k050110-synthes-usa-lcp-modular-foot-plates-fda-510k.jpg K050110 - SYNTHES (USA) LCP MODULAR FOOT PLATES K050110 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Mar 2005. https://www.510kdatabase.net/k050204/ 2005-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k050204-synthes-rapid-resorbable-tack-system-fda-510k.jpg K050204 - SYNTHES RAPID RESORBABLE TACK SYSTEM K050204 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Mar 2005. https://www.510kdatabase.net/k050403/ 2005-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k050403-spyglass-direct-visulation-probe-fda-510k.jpg K050403 - SPYGLASS DIRECT VISULATION PROBE K050403 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Mar 2005. https://www.510kdatabase.net/k043288/ 2005-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k043288-modification-to-intuitive-surgical-da-fda-510k.jpg K043288 - MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS K043288 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Mar 2005. https://www.510kdatabase.net/k050075/ 2005-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k050075-vitek-2-gram-positive-daptomycin-fda-510k.jpg K050075 - VITEK 2 GRAM POSITIVE DAPTOMYCIN K050075 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Feb 2005. https://www.510kdatabase.net/k050089/ 2005-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k050089-bd-phoenix-automated-microbiology-fda-510k.jpg K050089 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMPICILLIN-SULBACTAM (GP) 2-32 UG/ML K050089 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Feb 2005. https://www.510kdatabase.net/k050200/ 2005-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k050200-magnetom-trio-a-tim-system-fda-510k.jpg K050200 - MAGNETOM TRIO A TIM SYSTEM K050200 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 2005. https://www.510kdatabase.net/k050041/ 2005-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k050041-synthes-usa-sterile-sternal-fixation-fda-510k.jpg K050041 - SYNTHES (USA) STERILE STERNAL FIXATION SYSTEM K050041 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Feb 2005. https://www.510kdatabase.net/k043602/ 2005-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k043602-quadrant-retractor-system-fda-510k.jpg K043602 - QUADRANT RETRACTOR SYSTEM K043602 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Feb 2005. https://www.510kdatabase.net/k050380/ 2005-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k050380-xario-diagnostic-ultrasound-system-fda-510k.jpg K050380 - XARIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-660A K050380 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Feb 2005. https://www.510kdatabase.net/k050159/ 2005-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k050159-modification-to-3m-littmann-electronic-fda-510k.jpg K050159 - MODIFICATION TO: 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000 K050159 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: 3M Company. Cleared Feb 2005. https://www.510kdatabase.net/k050191/ 2005-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k050191-modification-to-bd-facscanto-system-fda-510k.jpg K050191 - MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWARE K050191 is a FDA 510(k) cleared hematology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Feb 2005. https://www.510kdatabase.net/k043145/ 2005-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k043145-bi-cortical-bio-post-and-washer-model-fda-510k.jpg K043145 - BI-CORTICAL BIO-POST AND WASHER, MODEL AR-1367B K043145 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Feb 2005. https://www.510kdatabase.net/k043440/ 2005-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k043440-smith-nephew-inc-revision-knee-system-fda-510k.jpg K043440 - SMITH & NEPHEW, INC. REVISION KNEE SYSTEM K043440 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Feb 2005. https://www.510kdatabase.net/k050076/ 2005-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k050076-vitek-2-gram-positive-ertapenem-fda-510k.jpg K050076 - VITEK 2 GRAM POSITIVE ERTAPENEM K050076 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Feb 2005. https://www.510kdatabase.net/k050282/ 2005-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k050282-modification-to-tsrh-spinal-system-fda-510k.jpg K050282 - MODIFICATION TO TSRH SPINAL SYSTEM K050282 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Feb 2005. https://www.510kdatabase.net/k043100/ 2005-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k043100-bio-modular-shoulder-system-with-fda-510k.jpg K043100 - BIO-MODULAR SHOULDER SYSTEM WITH HYDROXYAPATITE (HA) COATED GLENOID COMPONENTS K043100 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Feb 2005. https://www.510kdatabase.net/k043545/ 2005-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k043545-microscan-dried-gram-positive-miccombo-fda-510k.jpg K043545 - MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH DAPTOMYCIN (0.03 - 16 MCG/ML) K043545 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Feb 2005. https://www.510kdatabase.net/k050002/ 2005-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k050002-vitek-2-compact-fda-510k.jpg K050002 - VITEK 2 COMPACT K050002 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Feb 2005. https://www.510kdatabase.net/k050117/ 2005-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k050117-modification-to-pyramid-anterior-plate-fda-510k.jpg K050117 - MODIFICATION TO PYRAMID ANTERIOR PLATE FIXATION SYSTEM K050117 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Feb 2005. https://www.510kdatabase.net/k042360/ 2005-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k042360-varian-nasopharynx-applicator-fda-510k.jpg K042360 - VARIAN NASOPHARYNX APPLICATOR K042360 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Feb 2005. https://www.510kdatabase.net/k043248/ 2005-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k043248-tightrope-syndesmosis-repair-kit-fda-510k.jpg K043248 - TIGHTROPE SYNDESMOSIS REPAIR KIT, TITANIUM, MODEL AR-8920DS K043248 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Feb 2005. https://www.510kdatabase.net/k043374/ 2005-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k043374-duracon-conversion-and-x-small-fda-510k.jpg K043374 - DURACON CONVERSION AND X-SMALL SYMMETRIC PATELLA WITH PERI-APATITE COATING K043374 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Feb 2005. https://www.510kdatabase.net/k043431/ 2005-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k043431-gamma3-nail-system-fda-510k.jpg K043431 - GAMMA3 NAIL SYSTEM K043431 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Feb 2005. https://www.510kdatabase.net/k050103/ 2005-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k050103-xceed-nitinol-self-expanding-fda-510k.jpg K050103 - XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM K050103 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Abbott Laboratories. Cleared Feb 2005. https://www.510kdatabase.net/k042735/ 2005-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k042735-n-antisera-to-human-immunoglobulins-fda-510k.jpg K042735 - N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) K042735 is a FDA 510(k) cleared immunology medical device. Manufacturer: Dade Behring, Inc.. Cleared Feb 2005. https://www.510kdatabase.net/k043476/ 2005-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k043476-stratus-cs-acute-care-nt-probnp-fda-510k.jpg K043476 - STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, PBNP CALPAK CALIBRATOR, PBNP DILPAK DILUENT K043476 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Feb 2005. https://www.510kdatabase.net/k050240/ 2005-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k050240-modification-to-acuson-cv70-fda-510k.jpg K050240 - MODIFICATION TO ACUSON CV70 CARDIOVASCULAR SYSTEM K050240 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 2005. https://www.510kdatabase.net/k041940/ 2005-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k041940-howmedica-osteonics-zirconia-toughened-fda-510k.jpg K041940 - HOWMEDICA OSTEONICS ZIRCONIA-TOUGHENED-ALUMINA (BIOLOX DELTA) CERAMIC FEMORAL HEADS K041940 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Feb 2005. https://www.510kdatabase.net/k042757/ 2005-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k042757-vanguard-ssk-knee-system-fda-510k.jpg K042757 - VANGUARD SSK KNEE SYSTEM K042757 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Feb 2005. https://www.510kdatabase.net/k042992/ 2005-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k042992-corail-amt-hip-prosthesis-fda-510k.jpg K042992 - CORAIL AMT HIP PROSTHESIS K042992 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Feb 2005. https://www.510kdatabase.net/k043006/ 2005-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k043006-millennium-m10-oxygen-concentrator-fda-510k.jpg K043006 - MILLENNIUM M10 OXYGEN CONCENTRATOR, MODEL M10600 K043006 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Feb 2005. https://www.510kdatabase.net/k050226/ 2005-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k050226-asian-intramedullary-hip-screw-nails-fda-510k.jpg K050226 - ASIAN INTRAMEDULLARY HIP SCREW NAILS K050226 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Feb 2005. https://www.510kdatabase.net/k033716/ 2005-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k033716-trident-acetabular-system-fda-510k.jpg K033716 - TRIDENT ACETABULAR SYSTEM K033716 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Feb 2005. https://www.510kdatabase.net/k042513/ 2005-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k042513-vectorvision-osteotomy-fda-510k.jpg K042513 - VECTORVISION OSTEOTOMY K042513 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Feb 2005. https://www.510kdatabase.net/k050057/ 2005-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k050057-coulter-lh-750-hematology-analyzer-fda-510k.jpg K050057 - COULTER LH 750 HEMATOLOGY ANALYZER K050057 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Feb 2005. https://www.510kdatabase.net/k050062/ 2005-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k050062-gemifloxacin-5ug-bbl-sensi-disc-fda-510k.jpg K050062 - GEMIFLOXACIN, 5UG BBL SENSI-DISC K050062 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Feb 2005. https://www.510kdatabase.net/k050079/ 2005-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k050079-cd-horizon-spinal-system-fda-510k.jpg K050079 - CD HORIZON SPINAL SYSTEM K050079 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Feb 2005. https://www.510kdatabase.net/k042343/ 2005-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k042343-scorpio-nrg-knee-system-fda-510k.jpg K042343 - SCORPIO NRG KNEE SYSTEM K042343 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Feb 2005. https://www.510kdatabase.net/k043459/ 2005-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k043459-hemosil-factor-xii-deficient-plasma-fda-510k.jpg K043459 - HEMOSIL FACTOR XII DEFICIENT PLASMA K043459 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Feb 2005. https://www.510kdatabase.net/k043505/ 2005-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k043505-discovery-mosaic-total-humerus-system-fda-510k.jpg K043505 - DISCOVERY-MOSAIC TOTAL HUMERUS SYSTEM K043505 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Feb 2005. https://www.510kdatabase.net/k050202/ 2005-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k050202-cortisol-and-cortisol-calibrators-on-fda-510k.jpg K050202 - CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS K050202 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Feb 2005. https://www.510kdatabase.net/k050113/ 2005-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k050113-tina-quant-igg-gen2-fda-510k.jpg K050113 - TINA-QUANT IGG GEN.2 K050113 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Feb 2005. https://www.510kdatabase.net/k050120/ 2005-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k050120-easy-core-biopsy-system-ii-fda-510k.jpg K050120 - EASY CORE BIOPSY SYSTEM II K050120 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Feb 2005. https://www.510kdatabase.net/k043327/ 2005-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k043327-online-dat-benzodiazepines-plus-fda-510k.jpg K043327 - ONLINE DAT BENZODIAZEPINES PLUS K043327 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Feb 2005. https://www.510kdatabase.net/k043185/ 2005-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k043185-synthes-35mm-cortex-screws-fda-510k.jpg K043185 - SYNTHES 3.5MM CORTEX SCREWS K043185 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Feb 2005. https://www.510kdatabase.net/k043321/ 2005-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k043321-modification-to-cd-horizon-spinal-system-fda-510k.jpg K043321 - MODIFICATION TO: CD HORIZON SPINAL SYSTEM K043321 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Feb 2005. https://www.510kdatabase.net/k043517/ 2005-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k043517-transmitter-zs-940pa-series-fda-510k.jpg K043517 - TRANSMITTER, ZS-940PA SERIES K043517 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Feb 2005. https://www.510kdatabase.net/k043246/ 2005-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k043246-brachysource-brachytherapy-seed-implants-fda-510k.jpg K043246 - BRACHYSOURCE BRACHYTHERAPY SEED IMPLANTS K043246 is a FDA 510(k) cleared radiology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Feb 2005. https://www.510kdatabase.net/k050126/ 2005-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k050126-ge-logiq-twin-fda-510k.jpg K050126 - GE LOGIQ TWIN K050126 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Feb 2005. https://www.510kdatabase.net/k031782/ 2005-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k031782-gapp-graft-contianment-device-fda-510k.jpg K031782 - GAPP GRAFT CONTIANMENT DEVICE ORTHOPEDICS K031782 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Feb 2005. https://www.510kdatabase.net/k043151/ 2005-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k043151-modification-to-cd-horizon-spinal-system-fda-510k.jpg K043151 - MODIFICATION TO: CD HORIZON SPINAL SYSTEM K043151 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Feb 2005. https://www.510kdatabase.net/k043460/ 2005-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k043460-olympus-lyophilized-chemistry-fda-510k.jpg K043460 - OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071 K043460 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus America, Inc.. Cleared Jan 2005. https://www.510kdatabase.net/k050026/ 2005-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k050026-precinorm-proteins-in-urinecsf-puc-and-fda-510k.jpg K050026 - PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PUC K050026 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics. Cleared Jan 2005. https://www.510kdatabase.net/k050121/ 2005-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k050121-zimmer-periarticular-locking-plate-fda-510k.jpg K050121 - ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM, MODEL 2357 & 2359 K050121 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jan 2005. https://www.510kdatabase.net/k043504/ 2005-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k043504-palaimpact-fda-510k.jpg K043504 - PALAIMPACT K043504 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Jan 2005. https://www.510kdatabase.net/k043607/ 2005-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k043607-bipap-pro-2-bi-level-system-with-bi-flex-fda-510k.jpg K043607 - BIPAP PRO 2 BI-LEVEL SYSTEM WITH BI-FLEX K043607 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Jan 2005. https://www.510kdatabase.net/k043065/ 2005-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k043065-vigileo-arterial-pressure-cardiac-fda-510k.jpg K043065 - VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR, MODELS MIHM1 AND MIHM1P K043065 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Jan 2005. https://www.510kdatabase.net/k043583/ 2005-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k043583-charlotte-snap-off-screw-models-fda-510k.jpg K043583 - CHARLOTTE SNAP-OFF SCREW, MODELS 45110001, 45110002, 45110003 K043583 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jan 2005. https://www.510kdatabase.net/k043568/ 2005-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k043568-equestra-fluid-delivery-system-fda-510k.jpg K043568 - EQUESTRA FLUID DELIVERY SYSTEM K043568 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Jan 2005. https://www.510kdatabase.net/k050005/ 2005-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k050005-intuitive-surgical-monopolar-curved-fda-510k.jpg K050005 - INTUITIVE SURGICAL MONOPOLAR CURVED SCISSORS, MODEL 400179 K050005 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Jan 2005. https://www.510kdatabase.net/k042774/ 2005-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k042774-mallory-head-modular-calcar-stems-with-fda-510k.jpg K042774 - MALLORY-HEAD MODULAR CALCAR STEMS WITH INTERLOCKING SLOTS K042774 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jan 2005. https://www.510kdatabase.net/k043102/ 2005-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k043102-multi-use-compression-screw-fda-510k.jpg K043102 - MULTI-USE COMPRESSION SCREW K043102 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jan 2005. https://www.510kdatabase.net/k043113/ 2005-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k043113-tempfix-external-fixation-system-mr-safe-fda-510k.jpg K043113 - TEMPFIX EXTERNAL FIXATION SYSTEM, MR SAFE K043113 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jan 2005. https://www.510kdatabase.net/k043389/ 2005-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k043389-bd-phoenix-automated-microbiology-fda-510k.jpg K043389 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -AMPICILLIN-SULBACTAM (GN) 0.5/0.25-32/16UG/ML K043389 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Jan 2005. https://www.510kdatabase.net/k043415/ 2005-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k043415-centricity-pacs-system-fda-510k.jpg K043415 - CENTRICITY PACS SYSTEM K043415 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Jan 2005. https://www.510kdatabase.net/k043560/ 2005-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k043560-periarticular-locking-plates-and-fda-510k.jpg K043560 - PERIARTICULAR LOCKING PLATES AND SCREWS, SERIES 2358 AND 2359 K043560 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jan 2005. https://www.510kdatabase.net/k043215/ 2005-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k043215-flowcare-plg-cd4-reagent-fda-510k.jpg K043215 - FLOWCARE PLG CD4 REAGENT K043215 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jan 2005. https://www.510kdatabase.net/k043281/ 2005-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k043281-charlotte-high-demand-compression-screw-fda-510k.jpg K043281 - CHARLOTTE HIGH-DEMAND COMPRESSION SCREW K043281 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jan 2005. https://www.510kdatabase.net/k043039/ 2005-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k043039-synthes-usa-external-fixation-fda-510k.jpg K043039 - SYNTHES (USA) EXTERNAL FIXATION COMPONENT LINE EXTENSION - MR SAFE K043039 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jan 2005. https://www.510kdatabase.net/k043059/ 2005-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k043059-compression-staple-and-simple-staple-fda-510k.jpg K043059 - COMPRESSION STAPLE AND SIMPLE STAPLE K043059 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jan 2005. https://www.510kdatabase.net/k043546/ 2005-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k043546-dimension-rxl-max-with-streamlab-fda-510k.jpg K043546 - DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE K043546 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Jan 2005. https://www.510kdatabase.net/k042168/ 2005-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k042168-concord-radiopaque-bone-cement-fda-510k.jpg K042168 - CONCORD Radiopaque Bone Cement K042168 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Jan 2005. https://www.510kdatabase.net/k043252/ 2005-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k043252-cabling-system-trochanter-hook-fda-510k.jpg K043252 - CABLING SYSTEM TROCHANTER HOOK K043252 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jan 2005. https://www.510kdatabase.net/k043502/ 2005-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k043502-6-fr-poly-per-q-cath-triple-lumen-picc-fda-510k.jpg K043502 - 6 FR POLY PER-Q-CATH TRIPLE LUMEN PICC K043502 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 2005. https://www.510kdatabase.net/k043537/ 2005-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k043537-taperloc-1214-taper-femoral-components-fda-510k.jpg K043537 - TAPERLOC 12/14 TAPER FEMORAL COMPONENTS K043537 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jan 2005. https://www.510kdatabase.net/k042512/ 2005-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k042512-vectorvision-acl-fda-510k.jpg K042512 - VECTORVISION ACL K042512 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Jan 2005. https://www.510kdatabase.net/k050034/ 2005-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k050034-sonoline-antares-diagnostic-ultrasound-fda-510k.jpg K050034 - SONOLINE ANTARES DIAGNOSTIC ULTRASOUND SYSTEM K050034 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 2005. https://www.510kdatabase.net/k042896/ 2005-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k042896-smith-nephew-hybrid-knee-femoral-fda-510k.jpg K042896 - SMITH & NEPHEW HYBRID KNEE FEMORAL K042896 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jan 2005. https://www.510kdatabase.net/k042993/ 2005-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k042993-triathlon-posteriorly-stabilized-ps-fda-510k.jpg K042993 - TRIATHLON POSTERIORLY STABILIZED (PS) FEMORAL COMPONENT K042993 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jan 2005. https://www.510kdatabase.net/k043262/ 2005-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k043262-ge-signa-excite-mr-surgical-option-fda-510k.jpg K043262 - GE SIGNA EXCITE MR SURGICAL OPTION K043262 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Jan 2005. https://www.510kdatabase.net/k043395/ 2005-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k043395-smith-nephew-videoarthroscope-fda-510k.jpg K043395 - SMITH & NEPHEW VIDEOARTHROSCOPE K043395 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jan 2005. https://www.510kdatabase.net/k043563/ 2005-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k043563-dp-9900-digital-ultrasonic-diagnostic-fda-510k.jpg K043563 - DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM K043563 is a FDA 510(k) cleared radiology medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Jan 2005. https://www.510kdatabase.net/k043305/ 2005-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k043305-online-dat-phencyclidine-plus-fda-510k.jpg K043305 - ONLINE DAT PHENCYCLIDINE PLUS K043305 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jan 2005. https://www.510kdatabase.net/k043020/ 2005-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k043020-glaxy-32-spinal-system-fda-510k.jpg K043020 - GLAXY 3.2 SPINAL SYSTEM K043020 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Jan 2005. https://www.510kdatabase.net/k043028/ 2005-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k043028-emit-ii-plus-ecstasy-assay-fda-510k.jpg K043028 - EMIT II PLUS ECSTASY ASSAY K043028 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Dade Behring, Inc.. Cleared Jan 2005. https://www.510kdatabase.net/k043045/ 2005-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k043045-synthes-usa-chronos-fda-510k.jpg K043045 - SYNTHES (USA) CHRONOS K043045 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jan 2005. https://www.510kdatabase.net/k043208/ 2005-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k043208-liquid-assayed-multiqual-control-fda-510k.jpg K043208 - LIQUID ASSAYED MULTIQUAL CONTROL K043208 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Jan 2005. https://www.510kdatabase.net/k043566/ 2005-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k043566-modification-to-verte-stack-spinal-fda-510k.jpg K043566 - MODIFICATION TO VERTE-STACK SPINAL SYSTEM K043566 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Jan 2005. https://www.510kdatabase.net/k042827/ 2005-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k042827-cardiofax-ce-model-pea-1110k-fda-510k.jpg K042827 - CARDIOFAX CE, MODEL PEA-1110K K042827 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Jan 2005. https://www.510kdatabase.net/k042868/ 2005-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k042868-mammoreport-softcopy-workstation-fda-510k.jpg K042868 - MAMMOREPORT SOFTCOPY WORKSTATION K042868 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 2005. https://www.510kdatabase.net/k043348/ 2005-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k043348-modification-to-pm-8000-patient-monitor-fda-510k.jpg K043348 - MODIFICATION TO PM-8000 PATIENT MONITOR K043348 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Jan 2005. https://www.510kdatabase.net/k043295/ 2005-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k043295-versyodirect-fda-510k.jpg K043295 - VERSYO.DIRECT K043295 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Jan 2005. https://www.510kdatabase.net/k043310/ 2005-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k043310-synthes-usa-electric-pen-drive-system-fda-510k.jpg K043310 - SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM K043310 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jan 2005. https://www.510kdatabase.net/k043230/ 2004-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k043230-vitek-gram-negative-susceptibility-gns-fda-510k.jpg K043230 - VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR ERTAPENEM K043230 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Dec 2004. https://www.510kdatabase.net/k043211/ 2004-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k043211-online-dat-barbiturates-plus-fda-510k.jpg K043211 - ONLINE DAT BARBITURATES PLUS K043211 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Dec 2004. https://www.510kdatabase.net/k043397/ 2004-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k043397-modification-to-bd-eclipse-hypodermic-fda-510k.jpg K043397 - MODIFICATION TO BD ECLIPSE HYPODERMIC NEEDLE K043397 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson & CO. Cleared Dec 2004. https://www.510kdatabase.net/k043481/ 2004-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k043481-modification-to-zilver-635-biliary-stent-fda-510k.jpg K043481 - MODIFICATION TO: ZILVER 635 BILIARY STENT K043481 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook, Inc.. Cleared Dec 2004. https://www.510kdatabase.net/k043561/ 2004-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k043561-modification-to-verte-stack-spinal-fda-510k.jpg K043561 - MODIFICATION TO VERTE-STACK SPINAL SYSTEM K043561 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Dec 2004. https://www.510kdatabase.net/k043343/ 2004-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k043343-modification-to-cd-horizon-spinal-system-fda-510k.jpg K043343 - MODIFICATION TO: CD HORIZON SPINAL SYSTEM K043343 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Dec 2004. https://www.510kdatabase.net/k043403/ 2004-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k043403-cemex-system-genta-fast-bone-cement-fda-510k.jpg K043403 - CEMEX SYSTEM GENTA FAST BONE CEMENT K043403 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Dec 2004. https://www.510kdatabase.net/k043404/ 2004-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k043404-modification-to-t2-proximal-humeral-nail-fda-510k.jpg K043404 - MODIFICATION TO T2 PROXIMAL HUMERAL NAIL K043404 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Dec 2004. https://www.510kdatabase.net/k042985/ 2004-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k042985-lifestent-nt35-biliary-stent-system-fda-510k.jpg K042985 - LIFESTENT NT35 BILIARY STENT SYSTEM K042985 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Dec 2004. https://www.510kdatabase.net/k043086/ 2004-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k043086-somatom-respiratory-gating-fda-510k.jpg K043086 - SOMATOM RESPIRATORY GATING K043086 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Dec 2004. https://www.510kdatabase.net/k043202/ 2004-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k043202-olympus-creatine-kinase-reagent-fda-510k.jpg K043202 - OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279 K043202 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus America, Inc.. Cleared Dec 2004. https://www.510kdatabase.net/k043237/ 2004-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k043237-vitek-gram-negative-susceptibility-gns-fda-510k.jpg K043237 - VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR MOXIFLOXACIN K043237 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Dec 2004. https://www.510kdatabase.net/k043318/ 2004-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k043318-modification-to-roche-elecsys-folate-fda-510k.jpg K043318 - MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY K043318 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Dec 2004. https://www.510kdatabase.net/k042603/ 2004-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k042603-gynecare-prolene-fastener-system-fda-510k.jpg K042603 - GYNECARE PROLENE FASTENER SYSTEM K042603 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ethicon, Inc.. Cleared Dec 2004. https://www.510kdatabase.net/k042959/ 2004-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k042959-depuy-c-stem-amt-hip-prosthesis-fda-510k.jpg K042959 - DEPUY C-STEM AMT HIP PROSTHESIS K042959 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Dec 2004. https://www.510kdatabase.net/k042982/ 2004-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k042982-quantex-myoglobin-fda-510k.jpg K042982 - QUANTEX MYOGLOBIN K042982 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Dec 2004. https://www.510kdatabase.net/k043056/ 2004-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k043056-gore-seamguard-bioabsorbable-staple-fda-510k.jpg K043056 - GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL K043056 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Dec 2004. https://www.510kdatabase.net/k043081/ 2004-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k043081-gore-polypropylene-hernia-mesh-fda-510k.jpg K043081 - GORE POLYPROPYLENE HERNIA MESH K043081 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Dec 2004. https://www.510kdatabase.net/k043184/ 2004-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k043184-hemosil-recombiplastin-fda-510k.jpg K043184 - HEMOSIL RECOMBIPLASTIN K043184 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Dec 2004. https://www.510kdatabase.net/k043247/ 2004-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k043247-ducera-allceram-fda-510k.jpg K043247 - DUCERA ALLCERAM K043247 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Dec 2004. https://www.510kdatabase.net/k042789/ 2004-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k042789-vertex-reconstruction-system-fda-510k.jpg K042789 - VERTEX RECONSTRUCTION SYSTEM K042789 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Dec 2004. https://www.510kdatabase.net/k042841/ 2004-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k042841-m2ac2a-acetabular-system-fda-510k.jpg K042841 - M2A/C2A ACETABULAR SYSTEM K042841 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Dec 2004. https://www.510kdatabase.net/k043280/ 2004-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k043280-mimix-mp-bone-void-filler-fda-510k.jpg K043280 - MIMIX MP BONE VOID FILLER K043280 is a FDA 510(k) cleared neurology medical device. Manufacturer: Biomet, Inc.. Cleared Dec 2004. https://www.510kdatabase.net/k043291/ 2004-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k043291-cardioblate-dispersive-electrode-fda-510k.jpg K043291 - CARDIOBLATE DISPERSIVE ELECTRODE ADAPTER (ACCESSORY), MODEL 60884 K043291 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medtronic Vascular. Cleared Dec 2004. https://www.510kdatabase.net/k043482/ 2004-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k043482-the-reliance-pi-process-indicator-fda-510k.jpg K043482 - THE RELIANCE PI PROCESS INDICATOR, MODEL D5116 K043482 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Dec 2004. https://www.510kdatabase.net/k040049/ 2004-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k040049-the-reliance-endoscope-processing-system-fda-510k.jpg K040049 - THE RELIANCE ENDOSCOPE PROCESSING SYSTEM K040049 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Dec 2004. https://www.510kdatabase.net/k040592/ 2004-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k040592-cordis-steer-it-deflecting-tip-guidewire-fda-510k.jpg K040592 - CORDIS STEER-IT DEFLECTING TIP GUIDEWIRE K040592 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Dec 2004. https://www.510kdatabase.net/k042530/ 2004-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k042530-conserve-plus-ha-acetabular-shells-fda-510k.jpg K042530 - CONSERVE PLUS HA ACETABULAR SHELLS K042530 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Dec 2004. https://www.510kdatabase.net/k042878/ 2004-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k042878-flexitime-xtreme-fda-510k.jpg K042878 - FLEXITIME XTREME K042878 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Dec 2004. https://www.510kdatabase.net/k043320/ 2004-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k043320-modification-to-roche-elecsys-folate-fda-510k.jpg K043320 - MODIFICATION TO ROCHE ELECSYS FOLATE II CALCHECK II K043320 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Dec 2004. https://www.510kdatabase.net/k043087/ 2004-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k043087-somatom-care-contrast-ct-fda-510k.jpg K043087 - SOMATOM CARE CONTRAST CT K043087 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Dec 2004. https://www.510kdatabase.net/k043153/ 2004-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k043153-intuitive-surgical-da-vinci-surgical-fda-510k.jpg K043153 - INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS, MODELS IS1200 & IS1000 K043153 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Dec 2004. https://www.510kdatabase.net/k042552/ 2004-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k042552-bio-core-interference-screw-fda-510k.jpg K042552 - BIO-CORE INTERFERENCE SCREW K042552 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Dec 2004. https://www.510kdatabase.net/k042962/ 2004-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k042962-modification-to-cd-horizon-spinal-system-fda-510k.jpg K042962 - MODIFICATION TO CD HORIZON SPINAL SYSTEM K042962 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Dec 2004. https://www.510kdatabase.net/k043337/ 2004-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k043337-arthrex-bio-corkscrew-ft-suture-anchor-fda-510k.jpg K043337 - ARTHREX BIO-CORKSCREW FT SUTURE ANCHOR K043337 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Dec 2004. https://www.510kdatabase.net/k041623/ 2004-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k041623-reusable-sterilcontainer-filter-model-fda-510k.jpg K041623 - REUSABLE STERILCONTAINER FILTER MODEL #JK090 K041623 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Aesculap, Inc.. Cleared Dec 2004. https://www.510kdatabase.net/k042489/ 2004-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k042489-6f-z4-guide-catheter-fda-510k.jpg K042489 - 6F Z4 GUIDE CATHETER K042489 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Dec 2004. https://www.510kdatabase.net/k042963/ 2004-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k042963-vitek-gram-positive-susceptibility-gps-fda-510k.jpg K042963 - VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR ERTAPENEM K042963 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Dec 2004. https://www.510kdatabase.net/k041553/ 2004-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k041553-arthrex-suture-grafting-kit-fda-510k.jpg K041553 - ARTHREX SUTURE GRAFTING KIT K041553 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Arthrex, Inc.. Cleared Dec 2004. https://www.510kdatabase.net/k042687/ 2004-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k042687-enzygnost-f2-monoclonal-test-kit-fda-510k.jpg K042687 - ENZYGNOST F+2 (MONOCLONAL) TEST KIT K042687 is a FDA 510(k) cleared hematology medical device. Manufacturer: Dade Behring, Inc.. Cleared Dec 2004. https://www.510kdatabase.net/k043227/ 2004-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k043227-periarticular-locking-plates-2358-series-fda-510k.jpg K043227 - PERIARTICULAR LOCKING PLATES, 2358 SERIES K043227 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Dec 2004. https://www.510kdatabase.net/k043041/ 2004-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k043041-aesculap-t-bar-aneurysm-clips-titanium-fda-510k.jpg K043041 - AESCULAP T-BAR ANEURYSM CLIPS (TITANIUM & PHYNOX) K043041 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Dec 2004. https://www.510kdatabase.net/k043103/ 2004-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k043103-vigilance-ii-continuous-cardiac-fda-510k.jpg K043103 - VIGILANCE II CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VOLUMETRIC MONITOR, MODEL VIG2 K043103 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Dec 2004. https://www.510kdatabase.net/k042664/ 2004-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k042664-lps-upper-extremity-fda-510k.jpg K042664 - LPS UPPER EXTREMITY K042664 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Dec 2004. https://www.510kdatabase.net/k042946/ 2004-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k042946-vitek-gram-positive-susceptibility-gps-fda-510k.jpg K042946 - VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR RIFAMPIN K042946 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Dec 2004. https://www.510kdatabase.net/k043193/ 2004-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k043193-bard-inlayoptima-ureteral-stent-with-fda-510k.jpg K043193 - BARD INLAYOPTIMA URETERAL STENT WITH SUTURE K043193 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 2004. https://www.510kdatabase.net/k030052/ 2004-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k030052-ostim-fda-510k.jpg K030052 - OSTIM K030052 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Dec 2004. https://www.510kdatabase.net/k042406/ 2004-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k042406-olympus-lactate-osr6193-fda-510k.jpg K042406 - OLYMPUS LACTATE, OSR6193 K042406 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus America, Inc.. Cleared Dec 2004. https://www.510kdatabase.net/k043080/ 2004-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k043080-heparin-dose-response-controls-model-fda-510k.jpg K043080 - HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR K043080 is a FDA 510(k) cleared hematology medical device. Manufacturer: Medtronic Vascular. Cleared Dec 2004. https://www.510kdatabase.net/k042409/ 2004-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k042409-modular-arthrodesis-nail-fda-510k.jpg K042409 - MODULAR ARTHRODESIS NAIL K042409 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Dec 2004. https://www.510kdatabase.net/k042576/ 2004-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k042576-coatest-sp-fviii-fda-510k.jpg K042576 - COATEST SP FVIII K042576 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Dec 2004. https://www.510kdatabase.net/k042932/ 2004-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k042932-bd-phoenix-automated-microbiology-fda-510k.jpg K042932 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN-TAZOBACTAM 0.5/4-128/4 UG/ML K042932 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Dec 2004. https://www.510kdatabase.net/k042941/ 2004-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k042941-dade-behring-heparin-calibrator-and-fda-510k.jpg K042941 - DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS K042941 is a FDA 510(k) cleared hematology medical device. Manufacturer: Dade Behring, Inc.. Cleared Dec 2004. https://www.510kdatabase.net/k042333/ 2004-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k042333-control-plasma-n-proc-control-plasma-fda-510k.jpg K042333 - CONTROL PLASMA N, PROC CONTROL PLASMA K042333 is a FDA 510(k) cleared hematology medical device. Manufacturer: Dade Behring, Inc.. Cleared Dec 2004. https://www.510kdatabase.net/k040985/ 2004-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k040985-pump-connectivity-interface-fda-510k.jpg K040985 - PUMP CONNECTIVITY INTERFACE K040985 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Nov 2004. https://www.510kdatabase.net/k042936/ 2004-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k042936-solution-administration-with-luer-fda-510k.jpg K042936 - SOLUTION ADMINISTRATION WITH LUER ACCESS INJECTION SITE K042936 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Nov 2004. https://www.510kdatabase.net/k042865/ 2004-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k042865-liquichek-urine-toxicology-control-fda-510k.jpg K042865 - LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S) K042865 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Nov 2004. https://www.510kdatabase.net/k042995/ 2004-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k042995-x-leonardo-fda-510k.jpg K042995 - X-LEONARDO K042995 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2004. https://www.510kdatabase.net/k043052/ 2004-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k043052-trigen-hindfoot-fusion-nail-fda-510k.jpg K043052 - TRIGEN HINDFOOT FUSION NAIL K043052 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Nov 2004. https://www.510kdatabase.net/k043112/ 2004-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k043112-ge-02t-signa-profile-excite-mr-system-fda-510k.jpg K043112 - GE 0.2T SIGNA PROFILE EXCITE MR SYSTEM K043112 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Nov 2004. https://www.510kdatabase.net/k043175/ 2004-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k043175-elecsys-cortisol-test-system-addition-fda-510k.jpg K043175 - ELECSYS CORTISOL TEST SYSTEM, ADDITION OF SALIVA SAMPLE TYPE K043175 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Nov 2004. https://www.510kdatabase.net/k042883/ 2004-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k042883-size-1-triathlon-cruciate-retaining-cr-fda-510k.jpg K042883 - SIZE 1 TRIATHLON CRUCIATE RETAINING (CR) TIBIAL INSERT K042883 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Nov 2004. https://www.510kdatabase.net/k042987/ 2004-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k042987-modification-to-synthes-cranial-plates-fda-510k.jpg K042987 - MODIFICATION TO SYNTHES CRANIAL PLATES K042987 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Nov 2004. https://www.510kdatabase.net/k043095/ 2004-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k043095-roche-diagnostics-elecsys-afp-calset-ii-fda-510k.jpg K043095 - ROCHE DIAGNOSTICS ELECSYS AFP CALSET II K043095 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Nov 2004. https://www.510kdatabase.net/k031402/ 2004-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k031402-perfecta-femoral-stem-fda-510k.jpg K031402 - PERFECTA FEMORAL STEM K031402 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Nov 2004. https://www.510kdatabase.net/k042491/ 2004-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k042491-bd-onecath-peripherally-inserted-fda-510k.jpg K042491 - BD ONECATH PERIPHERALLY INSERTED CENTRAL CATHETER K042491 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson & CO. Cleared Nov 2004. https://www.510kdatabase.net/k042812/ 2004-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k042812-bblchromagar-mrsa-fda-510k.jpg K042812 - BBLCHROMAGAR MRSA K042812 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Nov 2004. https://www.510kdatabase.net/k042953/ 2004-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k042953-modification-to-protex-stabilization-fda-510k.jpg K042953 - MODIFICATION TO PROTEX STABILIZATION SYSTEM K042953 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Nov 2004. https://www.510kdatabase.net/k042127/ 2004-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k042127-smith-nephew-modular-hip-fda-510k.jpg K042127 - SMITH & NEPHEW MODULAR HIP K042127 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Nov 2004. https://www.510kdatabase.net/k042347/ 2004-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k042347-modification-to-dimension-nt-probnp-fda-510k.jpg K042347 - MODIFICATION TO DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD K042347 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Nov 2004. https://www.510kdatabase.net/k042365/ 2004-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k042365-synthes-usa-neuro-plate-and-screw-system-fda-510k.jpg K042365 - SYNTHES (USA) NEURO PLATE AND SCREW SYSTEM K042365 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Nov 2004. https://www.510kdatabase.net/k042694/ 2004-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k042694-advanced-lung-analysis-ii-fda-510k.jpg K042694 - ADVANCED LUNG ANALYSIS II K042694 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Nov 2004. https://www.510kdatabase.net/k042886/ 2004-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k042886-cd-horizon-spinal-system-fda-510k.jpg K042886 - CD HORIZON SPINAL SYSTEM K042886 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Nov 2004. https://www.510kdatabase.net/k043111/ 2004-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k043111-plaqueview-software-model-cspv-0001a-fda-510k.jpg K043111 - PLAQUEVIEW SOFTWARE, MODEL CSPV-0001A K043111 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Nov 2004. https://www.510kdatabase.net/k042459/ 2004-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k042459-synchron-lx-systems-hemoglobin-a1c2-fda-510k.jpg K042459 - SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2) REAGENT K042459 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Nov 2004. https://www.510kdatabase.net/k042761/ 2004-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k042761-wristore-distal-radius-fracture-fda-510k.jpg K042761 - WRISTORE DISTAL RADIUS FRACTURE FIXATOR, 4600 SERIES K042761 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Nov 2004. https://www.510kdatabase.net/k042986/ 2004-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k042986-modification-to-synthes-usa-synthes-fda-510k.jpg K042986 - MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEM K042986 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Nov 2004. https://www.510kdatabase.net/k043078/ 2004-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k043078-nemio-diagnostic-ultrasound-system-fda-510k.jpg K043078 - NEMIO DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-550A K043078 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Nov 2004. https://www.510kdatabase.net/k042895/ 2004-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k042895-synthes-lcp-dynamic-helical-hip-system-fda-510k.jpg K042895 - SYNTHES LCP DYNAMIC HELICAL HIP SYSTEM, ADDITIONAL HELIX BLADES K042895 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Nov 2004. https://www.510kdatabase.net/k043016/ 2004-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k043016-sonoline-orchid-diagnostic-ultrasound-fda-510k.jpg K043016 - SONOLINE ORCHID DIAGNOSTIC ULTRASOUND SYSTEM K043016 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2004. https://www.510kdatabase.net/k042291/ 2004-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k042291-unicel-dxc-600-and-800-synchron-systems-fda-510k.jpg K042291 - UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS K042291 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Nov 2004. https://www.510kdatabase.net/k042611/ 2004-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k042611-lunderquist-extra-stiff-double-curved-fda-510k.jpg K042611 - LUNDERQUIST EXTRA STIFF DOUBLE CURVED EXCHANGE WIRE GUIDE K042611 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Nov 2004. https://www.510kdatabase.net/k042855/ 2004-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k042855-intuitive-surgical-harmonic-curved-fda-510k.jpg K042855 - INTUITIVE SURGICAL HARMONIC CURVED SHEARS INSTRUMENT K042855 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Nov 2004. https://www.510kdatabase.net/k041818/ 2004-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k041818-sonicath-ultra-imaging-catheter-32f-fda-510k.jpg K041818 - SONICATH ULTRA IMAGING CATHETER 3.2F 20MHZ, MODELS 37410/456221/C1020 K041818 is a FDA 510(k) cleared radiology medical device. Manufacturer: Boston Scientific Corp. Cleared Nov 2004. https://www.510kdatabase.net/k041170/ 2004-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k041170-secur-fit-ha-and-secur-fit-plus-hip-fda-510k.jpg K041170 - SECUR-FIT HA AND SECUR-FIT PLUS HIP STEMS K041170 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Nov 2004. https://www.510kdatabase.net/k042029/ 2004-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k042029-x-series-integral-rpp-femoral-components-fda-510k.jpg K042029 - X-SERIES INTEGRAL RPP FEMORAL COMPONENTS K042029 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Nov 2004. https://www.510kdatabase.net/k042842/ 2004-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k042842-novation-1214-press-fit-femoral-stem-fda-510k.jpg K042842 - NOVATION 12/14 PRESS-FIT FEMORAL STEM K042842 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Nov 2004. https://www.510kdatabase.net/k042882/ 2004-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k042882-enteryx-injection-catheter-fda-510k.jpg K042882 - ENTERYX INJECTION CATHETER K042882 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Nov 2004. https://www.510kdatabase.net/k042935/ 2004-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k042935-gemini-gxl-fda-510k.jpg K042935 - GEMINI GXL K042935 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Nov 2004. https://www.510kdatabase.net/k042949/ 2004-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k042949-pelvilace-transobturator-biourethral-fda-510k.jpg K042949 - PELVILACE TRANSOBTURATOR BIOURETHRAL SUPPORT SYSTEM (PELVILACE TO SYSTEM) K042949 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 2004. https://www.510kdatabase.net/k042969/ 2004-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k042969-modification-to-smart-control-nitinol-fda-510k.jpg K042969 - MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM K042969 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Nov 2004. https://www.510kdatabase.net/k042617/ 2004-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k042617-31p1h-headcoil-for-magnetom-allegra-fda-510k.jpg K042617 - 31P/1H HEADCOIL FOR MAGNETOM ALLEGRA K042617 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2004. https://www.510kdatabase.net/k042815/ 2004-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k042815-quest-tumor-marker-control-model-955-fda-510k.jpg K042815 - QUEST TUMOR MARKER CONTROL, MODEL 955 K042815 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Nov 2004. https://www.510kdatabase.net/k042836/ 2004-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k042836-liquichek-reticulocyte-control-a-fda-510k.jpg K042836 - LIQUICHEK RETICULOCYTE CONTROL (A) K042836 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bio-Rad. Cleared Nov 2004. https://www.510kdatabase.net/k041189/ 2004-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k041189-arthrex-trimit-family-fda-510k.jpg K041189 - ARTHREX TRIMIT FAMILY K041189 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Nov 2004. https://www.510kdatabase.net/k041356/ 2004-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k041356-arthrex-tenodesis-screw-family-fda-510k.jpg K041356 - ARTHREX TENODESIS SCREW FAMILY K041356 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Nov 2004. https://www.510kdatabase.net/k042210/ 2004-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k042210-msd-silo-spinal-system-fda-510k.jpg K042210 - MSD SILO SPINAL SYSTEM K042210 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Nov 2004. https://www.510kdatabase.net/k042337/ 2004-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k042337-zimmer-ml-taper-hip-prosthesis-with-fda-510k.jpg K042337 - ZIMMER M/L TAPER HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING K042337 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Nov 2004. https://www.510kdatabase.net/k042776/ 2004-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k042776-versys-hip-system-beaded-midcoat-low-fda-510k.jpg K042776 - VERSYS HIP SYSTEM BEADED MIDCOAT LOW HEAD CENTER HIP PROSTHESIS, MODEL 00-7840-XXX-XX K042776 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Nov 2004. https://www.510kdatabase.net/k042790/ 2004-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k042790-cd-horizon-spinal-system-fda-510k.jpg K042790 - CD HORIZON SPINAL SYSTEM K042790 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Nov 2004. https://www.510kdatabase.net/k042905/ 2004-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k042905-neo-clip-orthodontic-bracket-accessory-fda-510k.jpg K042905 - NEO-CLIP ORTHODONTIC BRACKET ACCESSORY K042905 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Nov 2004. https://www.510kdatabase.net/k042642/ 2004-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k042642-aware-transport-monitor-system-fda-510k.jpg K042642 - AWARE TRANSPORT MONITOR SYSTEM (INCLUDES AWARE POD AND AWARE TRANSPORT MONITOR) K042642 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Nov 2004. https://www.510kdatabase.net/k040890/ 2004-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k040890-3m-tegaderm-silver-fda-510k.jpg K040890 - 3M TEGADERM SILVER K040890 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3M Company. Cleared Nov 2004. https://www.510kdatabase.net/k042837/ 2004-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k042837-liquichek-elevated-crp-control-fda-510k.jpg K042837 - LIQUICHEK ELEVATED CRP CONTROL K042837 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Nov 2004. https://www.510kdatabase.net/k041088/ 2004-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k041088-trifusion-model-06091900659350-fda-510k.jpg K041088 - TRIFUSION, MODEL 0609190/0659350 K041088 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 2004. https://www.510kdatabase.net/k042093/ 2004-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k042093-vanguard-m-series-unicondylar-tibial-fda-510k.jpg K042093 - VANGUARD M SERIES UNICONDYLAR TIBIAL BEARINGS K042093 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Nov 2004. https://www.510kdatabase.net/k041100/ 2004-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k041100-nexgen-porous-hatcp-uncemented-femoral-fda-510k.jpg K041100 - NEXGEN POROUS, HA/TCP, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS K041100 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Oct 2004. https://www.510kdatabase.net/k041490/ 2004-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k041490-iv-administration-sets-with-ultrablock-fda-510k.jpg K041490 - IV ADMINISTRATION SETS WITH ULTRABLOCK UV-RESISTANT TUBING K041490 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Oct 2004. https://www.510kdatabase.net/k042485/ 2004-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k042485-tina-quant-crp-latex-hs-test-system-c-fda-510k.jpg K042485 - TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE) K042485 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Oct 2004. https://www.510kdatabase.net/k042598/ 2004-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k042598-periarticular-locking-plates-and-fda-510k.jpg K042598 - PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES K042598 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Oct 2004. https://www.510kdatabase.net/k042724/ 2004-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k042724-modification-to-coulter-lh-500-fda-510k.jpg K042724 - MODIFICATION TO COULTER LH 500 HEMATOLOGY ANALYZER K042724 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Oct 2004. https://www.510kdatabase.net/k042839/ 2004-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k042839-c-pet-plus-imaging-system-fda-510k.jpg K042839 - C-PET PLUS IMAGING SYSTEM K042839 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Oct 2004. https://www.510kdatabase.net/k042407/ 2004-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k042407-emit-caffeine-assay-fda-510k.jpg K042407 - EMIT CAFFEINE ASSAY K042407 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Dade Behring, Inc.. Cleared Oct 2004. https://www.510kdatabase.net/k042934/ 2004-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k042934-1bd-soloshot-ix-syringe-fda-510k.jpg K042934 - 1BD SOLOSHOT IX SYRINGE K042934 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson & CO. Cleared Oct 2004. https://www.510kdatabase.net/k042355/ 2004-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k042355-synthes-usa-lcp-wrist-fusion-plates-fda-510k.jpg K042355 - SYNTHES (USA) LCP WRIST FUSION PLATES K042355 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Oct 2004. https://www.510kdatabase.net/k042833/ 2004-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k042833-sonoline-g20-diagnostic-ultrasound-fda-510k.jpg K042833 - SONOLINE G20 DIAGNOSTIC ULTRASOUND SYSTEMS K042833 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 2004. https://www.510kdatabase.net/k042021/ 2004-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k042021-exactech-equinoxe-shoulder-system-fda-510k.jpg K042021 - EXACTECH EQUINOXE SHOULDER SYSTEM K042021 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Oct 2004. https://www.510kdatabase.net/k041912/ 2004-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k041912-scbvalleylab-force-fx-interface-unit-fda-510k.jpg K041912 - SCB/VALLEYLAB FORCE FX INTERFACE UNIT K041912 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Oct 2004. https://www.510kdatabase.net/k041703/ 2004-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k041703-iplan-fda-510k.jpg K041703 - IPLAN! K041703 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Oct 2004. https://www.510kdatabase.net/k042591/ 2004-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k042591-smartmix-pre-filled-mixing-system-fda-510k.jpg K042591 - SMARTMIX PRE-FILLED MIXING SYSTEM K042591 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Oct 2004. https://www.510kdatabase.net/k042209/ 2004-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k042209-control-plasma-n-and-control-plasma-p-fda-510k.jpg K042209 - CONTROL PLASMA N AND CONTROL PLASMA P K042209 is a FDA 510(k) cleared hematology medical device. Manufacturer: Dade Behring, Inc.. Cleared Oct 2004. https://www.510kdatabase.net/k041988/ 2004-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k041988-arthrotek-meniscal-hybrid-device-fda-510k.jpg K041988 - ARTHROTEK MENISCAL HYBRID DEVICE K041988 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Oct 2004. https://www.510kdatabase.net/k042770/ 2004-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k042770-modification-to-acuson-cv70-fda-510k.jpg K042770 - MODIFICATION TO ACUSON CV70 CARDIOVASCULAR SYSTEM K042770 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 2004. https://www.510kdatabase.net/k042391/ 2004-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k042391-kolibri-image-guided-surgery-system-fda-510k.jpg K042391 - KOLIBRI IMAGE GUIDED SURGERY SYSTEM K042391 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Oct 2004. https://www.510kdatabase.net/k042539/ 2004-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k042539-gdc-10-360-degree-coil-sr-fda-510k.jpg K042539 - GDC-10 360 DEGREE COIL SR K042539 is a FDA 510(k) cleared neurology medical device. Manufacturer: Boston Scientific Corp. Cleared Oct 2004. https://www.510kdatabase.net/k041272/ 2004-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k041272-dyract-cem-plus-cement-fda-510k.jpg K041272 - DYRACT CEM PLUS CEMENT K041272 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Oct 2004. https://www.510kdatabase.net/k042175/ 2004-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k042175-heparinase-hr-act-control-model-550-12-fda-510k.jpg K042175 - HEPARINASE HR ACT CONTROL, MODEL 550-12 K042175 is a FDA 510(k) cleared hematology medical device. Manufacturer: Medtronic Vascular. Cleared Oct 2004. https://www.510kdatabase.net/k042206/ 2004-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k042206-purpleblack-heparin-assay-control-fda-510k.jpg K042206 - PURPLE/BLACK HEPARIN ASSAY CONTROL K042206 is a FDA 510(k) cleared hematology medical device. Manufacturer: Medtronic Vascular. Cleared Oct 2004. https://www.510kdatabase.net/k040875/ 2004-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k040875-cap-one-model-tg-920p-fda-510k.jpg K040875 - CAP-ONE, MODEL TG-920P K040875 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Oct 2004. https://www.510kdatabase.net/k041934/ 2004-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k041934-3m-littmann-electronic-stethoscope-fda-510k.jpg K041934 - 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000 K041934 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: 3M Company. Cleared Oct 2004. https://www.510kdatabase.net/k042568/ 2004-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k042568-excelsior-1018-and-sl-10-microcatheters-fda-510k.jpg K042568 - EXCELSIOR 1018 AND SL-10 MICROCATHETERS K042568 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Oct 2004. https://www.510kdatabase.net/k042593/ 2004-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k042593-acuson-acunav-8f-ultrasound-catheter-fda-510k.jpg K042593 - ACUSON ACUNAV 8F ULTRASOUND CATHETER K042593 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 2004. https://www.510kdatabase.net/k041222/ 2004-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k041222-pinnacle-tpn-management-system-fda-510k.jpg K041222 - PINNACLE TPN MANAGEMENT SYSTEM TRANSFER SET K041222 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Oct 2004. https://www.510kdatabase.net/k041525/ 2004-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k041525-hemovac-blood-reinfusion-system-fda-510k.jpg K041525 - HEMOVAC BLOOD REINFUSION SYSTEM K041525 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Zimmer, Inc.. Cleared Oct 2004. https://www.510kdatabase.net/k042271/ 2004-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k042271-nexgen-complete-knee-solution-lps-flex-fda-510k.jpg K042271 - NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX PROLONG HIGHLY CROSSLINKED POLYETHYLENE ARTICULAR SURFACES K042271 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Oct 2004. https://www.510kdatabase.net/k042173/ 2004-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k042173-coulter-a-t-5diff-cap-pierce-cp-fda-510k.jpg K042173 - COULTER A T 5DIFF CAP PIERCE (CP) K042173 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Oct 2004. https://www.510kdatabase.net/k042396/ 2004-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k042396-t2-proximal-humeral-nail-fda-510k.jpg K042396 - T2 PROXIMAL HUMERAL NAIL K042396 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Oct 2004. https://www.510kdatabase.net/k042410/ 2004-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k042410-baxject-ii-fda-510k.jpg K042410 - BAXJECT II K042410 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Oct 2004. https://www.510kdatabase.net/k042416/ 2004-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k042416-athena-multi-lyte-ana-ii-test-system-fda-510k.jpg K042416 - ATHENA MULTI-LYTE ANA-II TEST SYSTEM K042416 is a FDA 510(k) cleared immunology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Oct 2004. https://www.510kdatabase.net/k042524/ 2004-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k042524-modification-to-vertex-reconstruction-fda-510k.jpg K042524 - MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM K042524 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Oct 2004. https://www.510kdatabase.net/k042764/ 2004-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k042764-medline-strider-midi-4-fda-510k.jpg K042764 - MEDLINE STRIDER MIDI 4 K042764 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Medline Industries, Inc.. Cleared Oct 2004. https://www.510kdatabase.net/k041774/ 2004-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k041774-iur-reciprocating-morcellator-model-fda-510k.jpg K041774 - IUR RECIPROCATING MORCELLATOR MODEL # 7210517 K041774 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 2004. https://www.510kdatabase.net/k042032/ 2004-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k042032-maestro-total-wrist-fda-510k.jpg K042032 - MAESTRO TOTAL WRIST K042032 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Oct 2004. https://www.510kdatabase.net/k042135/ 2004-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k042135-synthes-usa-elastic-intramedullary-fda-510k.jpg K042135 - SYNTHES (USA) ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEM (LINE EXTENSION) K042135 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Oct 2004. https://www.510kdatabase.net/k042324/ 2004-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k042324-lyphochek-elevated-immunosuppressant-fda-510k.jpg K042324 - LYPHOCHEK ELEVATED IMMUNOSUPPRESSANT CONTROL, LEVEL 4, 5 K042324 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Oct 2004. https://www.510kdatabase.net/k042356/ 2004-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k042356-synthes-1012-mm-plusdrive-screws-fda-510k.jpg K042356 - SYNTHES 1.0/1.2 MM PLUSDRIVE SCREWS K042356 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Oct 2004. https://www.510kdatabase.net/k042358/ 2004-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k042358-locon-vls-distal-radius-plate-system-fda-510k.jpg K042358 - LOCON VLS DISTAL RADIUS PLATE SYSTEM K042358 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Oct 2004. https://www.510kdatabase.net/k042377/ 2004-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k042377-synthes-low-profile-reconstruction-fda-510k.jpg K042377 - SYNTHES LOW PROFILE RECONSTRUCTION PLATES K042377 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Oct 2004. https://www.510kdatabase.net/k042436/ 2004-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k042436-iiizarov-pulley-system-fda-510k.jpg K042436 - IIIZAROV PULLEY SYSTEM K042436 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 2004. https://www.510kdatabase.net/k042498/ 2004-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k042498-vertex-reconstruction-system-fda-510k.jpg K042498 - VERTEX RECONSTRUCTION SYSTEM K042498 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Oct 2004. https://www.510kdatabase.net/k042499/ 2004-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k042499-orion-anterior-cervical-plating-system-fda-510k.jpg K042499 - ORION ANTERIOR CERVICAL PLATING SYSTEM K042499 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Oct 2004. https://www.510kdatabase.net/k042763/ 2004-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k042763-modification-to-medline-strider-midi-3-fda-510k.jpg K042763 - MODIFICATION TO MEDLINE STRIDER MIDI 3 K042763 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Medline Industries, Inc.. Cleared Oct 2004. https://www.510kdatabase.net/k041899/ 2004-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k041899-vectorvision-uni-knee-fda-510k.jpg K041899 - VECTORVISION UNI-KNEE K041899 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Oct 2004. https://www.510kdatabase.net/k042651/ 2004-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k042651-free-t3-calibrators-on-the-access-fda-510k.jpg K042651 - FREE T3 CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS K042651 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Oct 2004. https://www.510kdatabase.net/k040601/ 2004-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k040601-exactech-acumatch-a-series-mcs-fda-510k.jpg K040601 - EXACTECH ACUMATCH A-SERIES & MCS CONSTRAINED ACETABULAR LINERS K040601 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Oct 2004. https://www.510kdatabase.net/k040889/ 2004-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k040889-exactech-optetrak-unicondylar-knee-fda-510k.jpg K040889 - EXACTECH OPTETRAK UNICONDYLAR KNEE K040889 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Oct 2004. https://www.510kdatabase.net/k041962/ 2004-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k041962-xpand-balloon-expandable-transhepatic-fda-510k.jpg K041962 - XPAND BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 20587, 20588, 20589, 20603, 20604, 20605 K041962 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Abbott Laboratories. Cleared Oct 2004. https://www.510kdatabase.net/k042037/ 2004-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k042037-m2a-magnum-system-fda-510k.jpg K042037 - M2A MAGNUM SYSTEM K042037 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Oct 2004. https://www.510kdatabase.net/k042070/ 2004-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k042070-heparin-dose-response-cartridge-model-fda-510k.jpg K042070 - HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20 K042070 is a FDA 510(k) cleared hematology medical device. Manufacturer: Medtronic Vascular. Cleared Oct 2004. https://www.510kdatabase.net/k042518/ 2004-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k042518-zilver-518-biliary-stent-fda-510k.jpg K042518 - ZILVER 518 BILIARY STENT K042518 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook, Inc.. Cleared Oct 2004. https://www.510kdatabase.net/k042525/ 2004-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k042525-centricity-radiology-ra600centricity-fda-510k.jpg K042525 - CENTRICITY RADIOLOGY RA600/CENTRICITY CARDIOLOGY CA1000/CENTRICITY DIGITAL HARDCOPY WORKSTATION K042525 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Oct 2004. https://www.510kdatabase.net/k042065/ 2004-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k042065-wallflex-enternal-colonic-stent-and-fda-510k.jpg K042065 - WALLFLEX ENTERNAL COLONIC STENT AND ANCHOR LOCK DELIVERY SYSTEM K042065 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Sep 2004. https://www.510kdatabase.net/k042488/ 2004-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k042488-perifix-catheter-and-contiplex-catheter-fda-510k.jpg K042488 - PERIFIX CATHETER AND CONTIPLEX CATHETER K042488 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Sep 2004. https://www.510kdatabase.net/k042490/ 2004-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k042490-elecsys-folate-ii-calset-ii-fda-510k.jpg K042490 - ELECSYS FOLATE II CALSET II K042490 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Sep 2004. https://www.510kdatabase.net/k040658/ 2004-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k040658-bardex-ic-latex-foley-catheter-fda-510k.jpg K040658 - BARDEX I.C. LATEX FOLEY CATHETER K040658 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Sep 2004. https://www.510kdatabase.net/k041739/ 2004-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k041739-edwards-e360-surgical-ablation-device-fda-510k.jpg K041739 - EDWARDS E360 SURGICAL ABLATION DEVICE K041739 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Sep 2004. https://www.510kdatabase.net/k041905/ 2004-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k041905-hemosil-calibration-plasma-fda-510k.jpg K041905 - HEMOSIL CALIBRATION PLASMA K041905 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 2004. https://www.510kdatabase.net/k042019/ 2004-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k042019-hoffmann-ii-micro-external-fixation-fda-510k.jpg K042019 - HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM K042019 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Sep 2004. https://www.510kdatabase.net/k042158/ 2004-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k042158-kodak-medical-imager-300-fda-510k.jpg K042158 - KODAK MEDICAL IMAGER 300 K042158 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Sep 2004. https://www.510kdatabase.net/k042159/ 2004-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k042159-kodak-color-medical-imager-1000-fda-510k.jpg K042159 - KODAK COLOR MEDICAL IMAGER 1000 K042159 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Sep 2004. https://www.510kdatabase.net/k042203/ 2004-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k042203-leonardo-syngo-cardiology-workstation-fda-510k.jpg K042203 - LEONARDO SYNGO CARDIOLOGY WORKSTATION K042203 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 2004. https://www.510kdatabase.net/k042312/ 2004-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k042312-jet-x-bar-clamps-and-pin-clamps-non-fda-510k.jpg K042312 - JET-X BAR CLAMPS AND PIN CLAMPS-NON-MAGNETIC/MR SAFE K042312 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Sep 2004. https://www.510kdatabase.net/k042412/ 2004-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k042412-modified-spacemaker-system-fda-510k.jpg K042412 - MODIFIED SPACEMAKER SYSTEM K042412 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Sep 2004. https://www.510kdatabase.net/k041591/ 2004-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k041591-scorpio-flex-posterior-stabilized-fda-510k.jpg K041591 - SCORPIO-FLEX POSTERIOR STABILIZED TIBIAL INSERT COMPONENTS K041591 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Sep 2004. https://www.510kdatabase.net/k042016/ 2004-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k042016-datascope-proguide-chronic-dialysis-fda-510k.jpg K042016 - DATASCOPE PROGUIDE CHRONIC DIALYSIS CATHETER K042016 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Datascope Corp.. Cleared Sep 2004. https://www.510kdatabase.net/k041330/ 2004-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k041330-iplan-flow-fda-510k.jpg K041330 - IPLAN! FLOW K041330 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Sep 2004. https://www.510kdatabase.net/k042205/ 2004-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k042205-bone-fusion-plate-system-fda-510k.jpg K042205 - BONE FUSION PLATE SYSTEM K042205 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Sep 2004. https://www.510kdatabase.net/k042235/ 2004-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k042235-orion-anterior-cervical-plating-system-fda-510k.jpg K042235 - ORION ANTERIOR CERVICAL PLATING SYSTEM K042235 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Sep 2004. https://www.510kdatabase.net/k041663/ 2004-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k041663-allomatrix-tcp-allomatrix-wcaso4-fda-510k.jpg K041663 - ALLOMATRIX TCP, ALLOMATRIX W/CASO4 FILLED TCP, AND ALLOMATRIX PLUS CBM K041663 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Sep 2004. https://www.510kdatabase.net/k042195/ 2004-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k042195-synchron-systems-hdl-cholesterol-hdl-fda-510k.jpg K042195 - SYNCHRON SYSTEMS HDL CHOLESTEROL (HDL), SYNCHRON SYSTEMS LIPID PLUS CALIBRATORS 1 & 2, MODELS A15625/A16747 K042195 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Sep 2004. https://www.510kdatabase.net/k042281/ 2004-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k042281-modification-to-access-hypersensitive-fda-510k.jpg K042281 - MODIFICATION TO ACCESS HYPERSENSITIVE HTSH ASSAY K042281 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Sep 2004. https://www.510kdatabase.net/k041862/ 2004-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k041862-cd-horizon-spinal-system-fda-510k.jpg K041862 - CD HORIZON SPINAL SYSTEM K041862 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Sep 2004. https://www.510kdatabase.net/k042194/ 2004-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k042194-attain-select-6238tel-guide-catheter-fda-510k.jpg K042194 - ATTAIN SELECT 6238TEL GUIDE CATHETER SET FOR LEFT-HEART DELIVERY K042194 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Sep 2004. https://www.510kdatabase.net/k041982/ 2004-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k041982-vitek-2-gram-negative-ertapenem-fda-510k.jpg K041982 - VITEK 2 GRAM NEGATIVE ERTAPENEM K041982 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Sep 2004. https://www.510kdatabase.net/k042389/ 2004-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k042389-modification-to-precinorm-universal-fda-510k.jpg K042389 - MODIFICATION TO PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA K042389 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Sep 2004. https://www.510kdatabase.net/k033341/ 2004-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k033341-smith-nephew-image-guided-surgical-fda-510k.jpg K033341 - SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS K033341 is a FDA 510(k) cleared neurology medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Sep 2004. https://www.510kdatabase.net/k041811/ 2004-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k041811-abbott-axsym-troponin-i-adv-fda-510k.jpg K041811 - ABBOTT AXSYM TROPONIN-I ADV K041811 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Sep 2004. https://www.510kdatabase.net/k041906/ 2004-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k041906-exactech-1214-total-hip-system-fda-510k.jpg K041906 - EXACTECH 12/14 TOTAL HIP SYSTEM K041906 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Sep 2004. https://www.510kdatabase.net/k042026/ 2004-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k042026-bard-ck-parastomal-hernia-patch-models-fda-510k.jpg K042026 - BARD CK PARASTOMAL HERNIA PATCH, MODELS 0118001, 0118002, 0118003, 0118004 K042026 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Sep 2004. https://www.510kdatabase.net/k041924/ 2004-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k041924-hausted-powertran-series-stretcher-fda-510k.jpg K041924 - HAUSTED POWERTRAN SERIES STRETCHER K041924 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: STERIS Corporation. Cleared Sep 2004. https://www.510kdatabase.net/k041611/ 2004-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k041611-synthes-usa-rapid-resorbable-cranial-fda-510k.jpg K041611 - SYNTHES (USA) RAPID RESORBABLE CRANIAL CLAMP K041611 is a FDA 510(k) cleared neurology medical device. Manufacturer: Synthes (Usa). Cleared Sep 2004. https://www.510kdatabase.net/k041706/ 2004-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k041706-hoffmann-ii-foot-ring-fda-510k.jpg K041706 - HOFFMANN II FOOT RING K041706 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Sep 2004. https://www.510kdatabase.net/k041709/ 2004-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k041709-numelock-ii-system-fda-510k.jpg K041709 - NUMELOCK II SYSTEM K041709 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Sep 2004. https://www.510kdatabase.net/k041860/ 2004-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k041860-synthes-usa-lcp-proximal-humerus-fda-510k.jpg K041860 - SYNTHES (USA) LCP PROXIMAL HUMERUS PLATES, LONG K041860 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Sep 2004. https://www.510kdatabase.net/k041911/ 2004-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k041911-synthes-usa-lcp-curved-plates-fda-510k.jpg K041911 - SYNTHES (USA) LCP CURVED PLATES K041911 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Sep 2004. https://www.510kdatabase.net/k041965/ 2004-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k041965-arthrex-humeral-fracture-plates-and-fda-510k.jpg K041965 - ARTHREX HUMERAL FRACTURE PLATES AND SCREWS K041965 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Sep 2004. https://www.510kdatabase.net/k042167/ 2004-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k042167-modification-to-cd-horizon-spinal-system-fda-510k.jpg K042167 - MODIFICATION TO: CD HORIZON SPINAL SYSTEM K042167 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Sep 2004. https://www.510kdatabase.net/k042257/ 2004-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k042257-discovery-st-petct-imaging-system-with-fda-510k.jpg K042257 - DISCOVERY ST PET/CT IMAGING SYSTEM WITH AN ALTERNATE DETECTOR OPTION K042257 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Sep 2004. https://www.510kdatabase.net/k042293/ 2004-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k042293-brilliance-ct-private-practice-cv-fda-510k.jpg K042293 - BRILLIANCE CT, PRIVATE PRACTICE CV CONFIGURATION, CT SCANNER K042293 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Sep 2004. https://www.510kdatabase.net/k042325/ 2004-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k042325-trochanteric-nail-system-fda-510k.jpg K042325 - TROCHANTERIC NAIL SYSTEM K042325 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Sep 2004. https://www.510kdatabase.net/k042190/ 2004-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k042190-model-6416-temporary-pacing-lead-system-fda-510k.jpg K042190 - MODEL 6416 TEMPORARY PACING LEAD SYSTEM K042190 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Sep 2004. https://www.510kdatabase.net/k041777/ 2004-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k041777-modification-to-cd-horizon-spinal-system-fda-510k.jpg K041777 - MODIFICATION TO CD HORIZON SPINAL SYSTEM K041777 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Sep 2004. https://www.510kdatabase.net/k040812/ 2004-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k040812-detect-surgical-pacing-and-mapping-tool-fda-510k.jpg K040812 - DETECT SURGICAL PACING AND MAPPING TOOL K040812 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Sep 2004. https://www.510kdatabase.net/k033491/ 2004-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k033491-roche-diagnostics-cardiac-d-dimer-fda-510k.jpg K033491 - ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY K033491 is a FDA 510(k) cleared hematology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Sep 2004. https://www.510kdatabase.net/k041533/ 2004-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k041533-synthes-usa-synthes-peri-prosthetic-fda-510k.jpg K041533 - SYNTHES (USA) [SYNTHES} PERI-PROSTHETIC SCREWS K041533 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Sep 2004. https://www.510kdatabase.net/k041549/ 2004-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k041549-zimmer-trabecular-metal-humeral-stem-fda-510k.jpg K041549 - ZIMMER TRABECULAR METAL HUMERAL STEM K041549 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Sep 2004. https://www.510kdatabase.net/k042178/ 2004-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k042178-orthodontic-ceramic-brackets-fda-510k.jpg K042178 - ORTHODONTIC CERAMIC BRACKETS K042178 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Aug 2004. https://www.510kdatabase.net/k041333/ 2004-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k041333-synthes-usa-titanium-wire-fda-510k.jpg K041333 - SYNTHES (USA) TITANIUM WIRE K041333 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Synthes (Usa). Cleared Aug 2004. https://www.510kdatabase.net/k041428/ 2004-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k041428-accusol-dialysis-solution-fda-510k.jpg K041428 - ACCUSOL DIALYSIS SOLUTION K041428 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Aug 2004. https://www.510kdatabase.net/k041683/ 2004-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k041683-b-braun-bicarbonate-dialysate-fda-510k.jpg K041683 - B. BRAUN BICARBONATE DIALYSATE K041683 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Aug 2004. https://www.510kdatabase.net/k042177/ 2004-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k042177-modification-to-mac-5000-ecg-analysis-fda-510k.jpg K042177 - MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM K042177 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Aug 2004. https://www.510kdatabase.net/k040476/ 2004-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k040476-storz-modulith-model-slx-f2-fda-510k.jpg K040476 - STORZ MODULITH, MODEL SLX-F2 K040476 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Aug 2004. https://www.510kdatabase.net/k040734/ 2004-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k040734-modification-to-restoration-modular-fda-510k.jpg K040734 - MODIFICATION TO RESTORATION MODULAR SYSTEM K040734 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Aug 2004. https://www.510kdatabase.net/k040368/ 2004-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k040368-vectorvision-hip-30-fda-510k.jpg K040368 - VECTORVISION HIP 3.0 K040368 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Aug 2004. https://www.510kdatabase.net/k041976/ 2004-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k041976-smith-nephew-graft-delivery-system-fda-510k.jpg K041976 - SMITH & NEPHEW GRAFT DELIVERY SYSTEM K041976 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Aug 2004. https://www.510kdatabase.net/k042036/ 2004-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k042036-airguard-valved-introducer-fda-510k.jpg K042036 - AIRGUARD VALVED INTRODUCER K042036 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Aug 2004. https://www.510kdatabase.net/k040542/ 2004-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k040542-smith-nephew-gts-sleeve-and-gts-fda-510k.jpg K040542 - SMITH & NEPHEW GTS SLEEVE AND GTS TAPERED SCREW K040542 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Aug 2004. https://www.510kdatabase.net/k041610/ 2004-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k041610-morce-scope-set-8970-with-power-fda-510k.jpg K041610 - MORCE SCOPE SET 8970 WITH POWER CONTROL 2303 AND SUCTION PUMP 2207 K041610 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Aug 2004. https://www.510kdatabase.net/k041668/ 2004-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k041668-olympus-crp-latex-immunoturbidimetric-fda-510k.jpg K041668 - OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT K041668 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus America, Inc.. Cleared Aug 2004. https://www.510kdatabase.net/k041887/ 2004-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k041887-synthes-usa-10122-mm-craniofacial-screws-fda-510k.jpg K041887 - SYNTHES (USA) 1.0/1.22 MM CRANIOFACIAL SCREWS K041887 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Aug 2004. https://www.510kdatabase.net/k041643/ 2004-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k041643-synchron-systems-phosphorus-phs-reagent-fda-510k.jpg K041643 - SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT K041643 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Aug 2004. https://www.510kdatabase.net/k041687/ 2004-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k041687-abbott-immunoassayclinical-chemistry-fda-510k.jpg K041687 - ABBOTT IMMUNOASSAY/CLINICAL CHEMISTRY SINGLE ANALYTE QUALITY CONTROL MATERIALS (ASSAYED) AND ABBOTT ESTRADIOL CALIBRATOR K041687 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Aug 2004. https://www.510kdatabase.net/k041878/ 2004-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k041878-n-latex-cystatin-fda-510k.jpg K041878 - N LATEX CYSTATIN K041878 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Aug 2004. https://www.510kdatabase.net/k042055/ 2004-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k042055-cypress-ultrasound-system-fda-510k.jpg K042055 - CYPRESS ULTRASOUND SYSTEM K042055 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 2004. https://www.510kdatabase.net/k042044/ 2004-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k042044-acuson-cv70-cardiovascular-system-fda-510k.jpg K042044 - ACUSON CV70 CARDIOVASCULAR SYSTEM K042044 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 2004. https://www.510kdatabase.net/k033843/ 2004-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k033843-spectrum-central-venous-catheter-with-fda-510k.jpg K033843 - SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATING K033843 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cook, Inc.. Cleared Aug 2004. https://www.510kdatabase.net/k041244/ 2004-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k041244-polygram-net-biofeedback-application-fda-510k.jpg K041244 - POLYGRAM NET BIOFEEDBACK APPLICATION K041244 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Aug 2004. https://www.510kdatabase.net/k041438/ 2004-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k041438-advanced-d-dimer-assay-fda-510k.jpg K041438 - ADVANCED D-DIMER ASSAY K041438 is a FDA 510(k) cleared hematology medical device. Manufacturer: Dade Behring, Inc.. Cleared Aug 2004. https://www.510kdatabase.net/k041197/ 2004-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k041197-modification-to-verte-stack-spinal-fda-510k.jpg K041197 - MODIFICATION TO VERTE-STACK SPINAL SYSTEM K041197 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Aug 2004. https://www.510kdatabase.net/k041827/ 2004-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k041827-dualflex-rx-ercp-cannula-models-4681-fda-510k.jpg K041827 - DUALFLEX RX ERCP CANNULA, MODELS 4681, 4682 K041827 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Boston Scientific Corp. Cleared Aug 2004. https://www.510kdatabase.net/k041589/ 2004-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k041589-arthrex-fiberwire-with-silk-fda-510k.jpg K041589 - ARTHREX FIBERWIRE WITH SILK K041589 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Arthrex, Inc.. Cleared Aug 2004. https://www.510kdatabase.net/k041415/ 2004-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k041415-eva-tpn-container-fda-510k.jpg K041415 - EVA TPN CONTAINER K041415 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Aug 2004. https://www.510kdatabase.net/k041519/ 2004-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k041519-modification-to-on-board-imager-device-fda-510k.jpg K041519 - MODIFICATION TO: ON-BOARD IMAGER DEVICE K041519 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Aug 2004. https://www.510kdatabase.net/k041384/ 2004-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k041384-bd-phoenix-automated-microbiology-fda-510k.jpg K041384 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAZIDIME - GRAM NEGATIVE K041384 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Aug 2004. https://www.510kdatabase.net/k041168/ 2004-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k041168-allomatrix-putty-fda-510k.jpg K041168 - ALLOMATRIX PUTTY K041168 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Aug 2004. https://www.510kdatabase.net/k041352/ 2004-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k041352-compress-distal-femoral-replacement-fda-510k.jpg K041352 - COMPRESS DISTAL FEMORAL REPLACEMENT SYSTEM K041352 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jul 2004. https://www.510kdatabase.net/k041355/ 2004-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k041355-humeral-staple-fda-510k.jpg K041355 - HUMERAL STAPLE K041355 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 2004. https://www.510kdatabase.net/k041484/ 2004-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k041484-undecided-fda-510k.jpg K041484 - UNDECIDED K041484 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 2004. https://www.510kdatabase.net/k041707/ 2004-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k041707-cercon-ceram-express-ceramic-system-fda-510k.jpg K041707 - CERCON CERAM EXPRESS CERAMIC SYSTEM K041707 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jul 2004. https://www.510kdatabase.net/k031858/ 2004-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k031858-neuro-endoscope-system-by-hopf-fda-510k.jpg K031858 - NEURO-ENDOSCOPE SYSTEM BY HOPF, EXISTING OF: ENDOSCOPES, SHEATHS, WORKING ELEMENTS, BIPOLAR AND UNIPOLAR ELECTRODES K031858 is a FDA 510(k) cleared neurology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Jul 2004. https://www.510kdatabase.net/k041044/ 2004-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k041044-ciaglia-cheetah-percutaneous-fda-510k.jpg K041044 - CIAGLIA CHEETAH PERCUTANEOUS TRACHEOSTOMY INTRODUCER SET K041044 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Cook, Inc.. Cleared Jul 2004. https://www.510kdatabase.net/k041955/ 2004-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k041955-gemini-petct-imaging-system-fda-510k.jpg K041955 - GEMINI PET/CT IMAGING SYSTEM K041955 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Jul 2004. https://www.510kdatabase.net/k033463/ 2004-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k033463-edwards-lifesciences-research-medical-fda-510k.jpg K033463 - EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC ARTERIAL CANNULAE K033463 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Jul 2004. https://www.510kdatabase.net/k041922/ 2004-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k041922-ge-tethered-portable-digital-fda-510k.jpg K041922 - GE TETHERED PORTABLE DIGITAL RADIOGRAPHIC DETECTOR K041922 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jul 2004. https://www.510kdatabase.net/k041328/ 2004-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k041328-smith-nephew-electroblade-fda-510k.jpg K041328 - SMITH & NEPHEW ELECTROBLADE RESECTOR/ADAPTOR K041328 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 2004. https://www.510kdatabase.net/k041812/ 2004-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k041812-modification-to-roche-diagnostics-fda-510k.jpg K041812 - MODIFICATION TO ROCHE DIAGNOSTICS PRECINORM PROTEINS IN URINE/CSF (PUC) AND PRECIPATH PROTEINS IN URINE/CSF (PUC) K041812 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jul 2004. https://www.510kdatabase.net/k041870/ 2004-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k041870-n-apolipoprotein-standard-serum-fda-510k.jpg K041870 - N APOLIPOPROTEIN STANDARD SERUM K041870 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Jul 2004. https://www.510kdatabase.net/k041842/ 2004-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k041842-norian-srs-fast-set-putty-fda-510k.jpg K041842 - NORIAN SRS FAST SET PUTTY K041842 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jul 2004. https://www.510kdatabase.net/k041907/ 2004-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k041907-trio-monitor-fda-510k.jpg K041907 - TRIO MONITOR K041907 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Jul 2004. https://www.510kdatabase.net/k040931/ 2004-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k040931-patxfer-rt-fda-510k.jpg K040931 - PATXFER RT K040931 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab AG. Cleared Jul 2004. https://www.510kdatabase.net/k041085/ 2004-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k041085-lps-limb-preservation-system-lower-fda-510k.jpg K041085 - LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARY K041085 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jul 2004. https://www.510kdatabase.net/k041150/ 2004-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k041150-microscan-synergies-plus-gram-negative-fda-510k.jpg K041150 - MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS K041150 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Jul 2004. https://www.510kdatabase.net/k041439/ 2004-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k041439-sas-influenza-b-test-fda-510k.jpg K041439 - SAS INFLUENZA B TEST K041439 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Jul 2004. https://www.510kdatabase.net/k041441/ 2004-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k041441-sas-influenza-a-test-fda-510k.jpg K041441 - SAS INFLUENZA A TEST K041441 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Jul 2004. https://www.510kdatabase.net/k041453/ 2004-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k041453-smith-nephew-tumescent-catheter-fda-510k.jpg K041453 - SMITH & NEPHEW TUMESCENT CATHETER INVERSION SYSTEM, MODEL 7210023 K041453 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 2004. https://www.510kdatabase.net/k041716/ 2004-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k041716-ptfe-felts-and-pledgets-fda-510k.jpg K041716 - PTFE FELTS AND PLEDGETS K041716 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Jul 2004. https://www.510kdatabase.net/k041112/ 2004-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k041112-magnetom-espree-system-fda-510k.jpg K041112 - MAGNETOM ESPREE SYSTEM K041112 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 2004. https://www.510kdatabase.net/k041423/ 2004-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k041423-viabil-biliary-endoprosthesis-fda-510k.jpg K041423 - VIABIL BILIARY ENDOPROSTHESIS K041423 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Jul 2004. https://www.510kdatabase.net/k041568/ 2004-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k041568-eocd-fda-510k.jpg K041568 - EOCD K041568 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Jul 2004. https://www.510kdatabase.net/k041109/ 2004-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k041109-zimmer-anatomic-ii-hip-prosthesis-fda-510k.jpg K041109 - ZIMMER ANATOMIC II HIP PROSTHESIS K041109 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jul 2004. https://www.510kdatabase.net/k041417/ 2004-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k041417-dimension-nt-probnp-flex-reagent-fda-510k.jpg K041417 - DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD, DIMENSION PBNP CALIBRATOR, MODELS RF423, RC423 K041417 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Jul 2004. https://www.510kdatabase.net/k041338/ 2004-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k041338-medtronic-octopus-te-stabilizer-fda-510k.jpg K041338 - MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIES K041338 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jul 2004. https://www.510kdatabase.net/k041111/ 2004-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k041111-magnetom-c-mr-system-fda-510k.jpg K041111 - MAGNETOM C! MR SYSTEM K041111 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 2004. https://www.510kdatabase.net/k041793/ 2004-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k041793-olympus-unsaturated-iron-binding-fda-510k.jpg K041793 - OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0SR6524 K041793 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus America, Inc.. Cleared Jul 2004. https://www.510kdatabase.net/k040980/ 2004-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k040980-allomatrix-c-putty-allomatrix-custom-fda-510k.jpg K040980 - ALLOMATRIX C PUTTY, ALLOMATRIX CUSTOM PUTTY, ALLOMATRIX DR PUTTY, IGNITE SCAFFOLD, MODELS 860C, 86XC, 86DR, 860D, 860T K040980 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jul 2004. https://www.510kdatabase.net/k040281/ 2004-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k040281-lps-metaphyseal-sleeve-limb-fda-510k.jpg K040281 - LPS METAPHYSEAL SLEEVE (LIMB PRESERVATION SYSTEM) K040281 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jul 2004. https://www.510kdatabase.net/k041321/ 2004-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k041321-veroscope-optical-veress-cannula-fda-510k.jpg K041321 - VEROSCOPE OPTICAL VERESS CANNULA & DILATION TUBE SYSTEM K041321 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Jul 2004. https://www.510kdatabase.net/k041586/ 2004-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k041586-profemur-s-hip-stem-fda-510k.jpg K041586 - PROFEMUR S HIP STEM K041586 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jul 2004. https://www.510kdatabase.net/k031454/ 2004-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k031454-acumen-surgical-navigation-system-fda-510k.jpg K031454 - ACUMEN SURGICAL NAVIGATION SYSTEM K031454 is a FDA 510(k) cleared neurology medical device. Manufacturer: Biomet, Inc.. Cleared Jul 2004. https://www.510kdatabase.net/k040841/ 2004-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k040841-powder-free-nitrile-examination-gloves-fda-510k.jpg K040841 - POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS) K040841 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Jul 2004. https://www.510kdatabase.net/k041350/ 2004-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k041350-synthes-usa-chronos-fda-510k.jpg K041350 - SYNTHES (USA) CHRONOS K041350 is a FDA 510(k) cleared neurology medical device. Manufacturer: Synthes (Usa). Cleared Jul 2004. https://www.510kdatabase.net/k041688/ 2004-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k041688-ge-voluson-730-proexpert-untrasound-bt04-fda-510k.jpg K041688 - GE VOLUSON 730 PRO/EXPERT UNTRASOUND BT04 K041688 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jul 2004. https://www.510kdatabase.net/k033926/ 2004-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k033926-hourglass-vertebral-body-spacer-fda-510k.jpg K033926 - HOURGLASS VERTEBRAL BODY SPACER K033926 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Jul 2004. https://www.510kdatabase.net/k040237/ 2004-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k040237-intuitive-surgical-da-vinci-endoscopic-fda-510k.jpg K040237 - INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENT CONTROL SYSTEM AND ENDOSCOPIC INSTRUMENTS K040237 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Jul 2004. https://www.510kdatabase.net/k041606/ 2004-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k041606-extractor-rx-retrieval-balloon-fda-510k.jpg K041606 - EXTRACTOR RX RETRIEVAL BALLOON K041606 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Jul 2004. https://www.510kdatabase.net/k041561/ 2004-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k041561-liquichek-whole-blood-volatiles-control-fda-510k.jpg K041561 - LIQUICHEK WHOLE BLOOD VOLATILES CONTROL K041561 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Jul 2004. https://www.510kdatabase.net/k041552/ 2004-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k041552-ge-vivid-7-bt04-fda-510k.jpg K041552 - GE VIVID 7 BT04 K041552 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jul 2004. https://www.510kdatabase.net/k041576/ 2004-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k041576-sourcelink-fda-510k.jpg K041576 - SOURCELINK K041576 is a FDA 510(k) cleared radiology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jul 2004. https://www.510kdatabase.net/k033959/ 2004-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k033959-lps-fda-510k.jpg K033959 - LPS K033959 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jul 2004. https://www.510kdatabase.net/k040155/ 2004-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k040155-peripheral-cutting-balloon-fda-510k.jpg K040155 - PERIPHERAL CUTTING BALLOON K040155 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Jul 2004. https://www.510kdatabase.net/k040907/ 2004-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k040907-arthrex-small-fragment-plates-and-screws-fda-510k.jpg K040907 - ARTHREX SMALL FRAGMENT PLATES AND SCREWS K040907 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jul 2004. https://www.510kdatabase.net/k040938/ 2004-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k040938-radial-nail-system-fda-510k.jpg K040938 - RADIAL NAIL SYSTEM K040938 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jul 2004. https://www.510kdatabase.net/k041001/ 2004-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k041001-omega-2-system-fda-510k.jpg K041001 - OMEGA 2 SYSTEM K041001 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jul 2004. https://www.510kdatabase.net/k041106/ 2004-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k041106-revision-knee-system-fda-510k.jpg K041106 - REVISION KNEE SYSTEM K041106 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 2004. https://www.510kdatabase.net/k041460/ 2004-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k041460-cd-horizon-spinal-system-fda-510k.jpg K041460 - CD HORIZON SPINAL SYSTEM K041460 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Jul 2004. https://www.510kdatabase.net/k041556/ 2004-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k041556-modification-to-verte-stack-spinal-fda-510k.jpg K041556 - MODIFICATION TO VERTE-STACK SPINAL SYSTEM K041556 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Jul 2004. https://www.510kdatabase.net/k041641/ 2004-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k041641-davol-delivery-system-fda-510k.jpg K041641 - DAVOL DELIVERY SYSTEM K041641 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jul 2004. https://www.510kdatabase.net/k041656/ 2004-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k041656-modification-to-depuy-1-gentamicin-fda-510k.jpg K041656 - MODIFICATION TO DEPUY 1 GENTAMICIN BONE CEMENT AND SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT K041656 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jul 2004. https://www.510kdatabase.net/k041030/ 2004-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k041030-modification-to-cd-horizon-spinal-system-fda-510k.jpg K041030 - MODIFICATION TO CD HORIZON SPINAL SYSTEM K041030 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Jun 2004. https://www.510kdatabase.net/k041550/ 2004-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k041550-hospira-phoenix-infusion-system-with-fda-510k.jpg K041550 - HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE K041550 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Jun 2004. https://www.510kdatabase.net/k041457/ 2004-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k041457-liquichek-hematology-control-a-fda-510k.jpg K041457 - LIQUICHEK HEMATOLOGY CONTROL (A) K041457 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bio-Rad. Cleared Jun 2004. https://www.510kdatabase.net/k040885/ 2004-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k040885-quanta-lite-gp210-elisa-fda-510k.jpg K040885 - QUANTA LITE GP210 ELISA K040885 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Jun 2004. https://www.510kdatabase.net/k041191/ 2004-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k041191-colleague-volumetric-infusion-pumps-fda-510k.jpg K041191 - COLLEAGUE VOLUMETRIC INFUSION PUMPS K041191 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jun 2004. https://www.510kdatabase.net/k041425/ 2004-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k041425-conserve-plus-revision-shell-and-fda-510k.jpg K041425 - CONSERVE PLUS REVISION SHELL AND CONSERVE PLUS THICK SHELL K041425 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jun 2004. https://www.510kdatabase.net/k041452/ 2004-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k041452-modification-to-verte-stack-spinal-fda-510k.jpg K041452 - MODIFICATION TO VERTE-STACK SPINAL SYSTEM K041452 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Jun 2004. https://www.510kdatabase.net/k033464/ 2004-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k033464-edwards-lifesciences-research-medical-fda-510k.jpg K033464 - EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC VENOUS RETURN CANNULAE K033464 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Jun 2004. https://www.510kdatabase.net/k041518/ 2004-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k041518-codman-duraform-dural-graft-implant-fda-510k.jpg K041518 - CODMAN DURAFORM DURAL GRAFT IMPLANT K041518 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Jun 2004. https://www.510kdatabase.net/k041543/ 2004-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k041543-ge-discovery-st-fda-510k.jpg K041543 - GE DISCOVERY ST K041543 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Healthcare. Cleared Jun 2004. https://www.510kdatabase.net/k033868/ 2004-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k033868-synthes-usa-patient-specific-fda-510k.jpg K033868 - SYNTHES (USA) PATIENT SPECIFIC CRANIAL/CRANIOFACIAL IMPLANTS K033868 is a FDA 510(k) cleared neurology medical device. Manufacturer: Synthes (Usa). Cleared Jun 2004. https://www.510kdatabase.net/k040777/ 2004-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k040777-lcp-radial-head-plating-system-fda-510k.jpg K040777 - LCP RADIAL HEAD PLATING SYSTEM K040777 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jun 2004. https://www.510kdatabase.net/k040721/ 2004-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k040721-assure-anterior-cervical-plate-system-fda-510k.jpg K040721 - ASSURE ANTERIOR CERVICAL PLATE SYSTEM K040721 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Jun 2004. https://www.510kdatabase.net/k040749/ 2004-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k040749-modular-replacement-system-cemented-fda-510k.jpg K040749 - MODULAR REPLACEMENT SYSTEM CEMENTED STEMS K040749 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jun 2004. https://www.510kdatabase.net/k040755/ 2004-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k040755-exactech-resorbable-room-temperature-fda-510k.jpg K040755 - EXACTECH RESORBABLE ROOM TEMPERATURE BONE PASTE K040755 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Jun 2004. https://www.510kdatabase.net/k040906/ 2004-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k040906-calibra-cement-fda-510k.jpg K040906 - CALIBRA CEMENT K040906 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jun 2004. https://www.510kdatabase.net/k041141/ 2004-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k041141-dentsply-cavitron-jet-wave-air-fda-510k.jpg K041141 - DENTSPLY CAVITRON JET WAVE AIR POLISHING PROPHYLAXIS SYSTEM, MODEL G125 K041141 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jun 2004. https://www.510kdatabase.net/k040701/ 2004-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k040701-synthes-usa-hydroxyapatite-ha-coated-fda-510k.jpg K040701 - SYNTHES (USA) HYDROXYAPATITE (HA) COATED SCHANZ SCREWS K040701 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jun 2004. https://www.510kdatabase.net/k041220/ 2004-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k041220-ge-discovery-st-system-fda-510k.jpg K041220 - GE DISCOVERY ST SYSTEM K041220 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Jun 2004. https://www.510kdatabase.net/k040680/ 2004-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k040680-contour-ha-coated-reconstruction-ring-fda-510k.jpg K040680 - CONTOUR HA COATED RECONSTRUCTION RING K040680 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jun 2004. https://www.510kdatabase.net/k033552/ 2004-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k033552-jax-tcp-fda-510k.jpg K033552 - JAX-TCP K033552 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jun 2004. https://www.510kdatabase.net/k040882/ 2004-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k040882-vidas-d-dimer-exclusion-assay-model-30-fda-510k.jpg K040882 - VIDAS D-DIMER EXCLUSION ASSAY, MODEL 30 442 K040882 is a FDA 510(k) cleared hematology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jun 2004. https://www.510kdatabase.net/k041296/ 2004-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k041296-modification-to-hakim-precision-valve-fda-510k.jpg K041296 - MODIFICATION TO HAKIM PRECISION VALVE SYSTEM, HAKIM PROGRAMMABLE VALVE SYSTEM, HAKIM MICRO PROGRAMMABLE VALVE SYSTEM, SI K041296 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Jun 2004. https://www.510kdatabase.net/k040845/ 2004-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k040845-vitek-2-esbl-test-fda-510k.jpg K040845 - VITEK 2 ESBL TEST K040845 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jun 2004. https://www.510kdatabase.net/k040767/ 2004-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k040767-synchron-systems-hdl-cholesterol-hdld-fda-510k.jpg K040767 - SYNCHRON SYSTEMS HDL CHOLESTEROL (HDLD) REAGENT K040767 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jun 2004. https://www.510kdatabase.net/k041216/ 2004-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k041216-smith-nephew-ultrabraid-suture-fda-510k.jpg K041216 - SMITH & NEPHEW ULTRABRAID SUTURE K041216 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jun 2004. https://www.510kdatabase.net/k041281/ 2004-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k041281-datascope-75fr-iab-catheter-and-fda-510k.jpg K041281 - DATASCOPE 7.5FR. IAB CATHETER AND ACCESSORIES K041281 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Jun 2004. https://www.510kdatabase.net/k041319/ 2004-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k041319-sequoia-diagnostic-ultrasound-system-fda-510k.jpg K041319 - SEQUOIA DIAGNOSTIC ULTRASOUND SYSTEM K041319 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 2004. https://www.510kdatabase.net/k040559/ 2004-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k040559-modification-to-unity-network-id-fda-510k.jpg K040559 - MODIFICATION TO UNITY NETWORK ID K040559 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Jun 2004. https://www.510kdatabase.net/k040611/ 2004-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k040611-modular-radial-head-replacement-device-fda-510k.jpg K040611 - MODULAR RADIAL HEAD REPLACEMENT DEVICE K040611 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jun 2004. https://www.510kdatabase.net/k040613/ 2004-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k040613-exactech-acumatch-a-series-and-mcs-fda-510k.jpg K040613 - EXACTECH ACUMATCH A-SERIES AND MCS ACETABULAR SHELLS AND LINERS K040613 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Jun 2004. https://www.510kdatabase.net/k040789/ 2004-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k040789-durabraid-suture-fda-510k.jpg K040789 - DURABRAID SUTURE K040789 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jun 2004. https://www.510kdatabase.net/k040458/ 2004-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k040458-modification-to-dash-30004000-patient-fda-510k.jpg K040458 - MODIFICATION TO DASH 3000/4000 PATIENT MONITOR K040458 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Jun 2004. https://www.510kdatabase.net/k033489/ 2004-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k033489-agc-total-knee-system-knee-ascent-fda-510k.jpg K033489 - AGC TOTAL KNEE SYSTEM KNEE, ASCENT TOTAL KNEE SYSTEM, MAXIM COMPLETE KNEE SYSTEM, MAXIM ACCEL KNEE SYSTEM ALSO KNOWN K033489 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jun 2004. https://www.510kdatabase.net/k040395/ 2004-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k040395-central-telemetry-system-model-wep-fda-510k.jpg K040395 - CENTRAL TELEMETRY SYSTEM, MODEL WEP-4200A SERIES K040395 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Jun 2004. https://www.510kdatabase.net/k040869/ 2004-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k040869-export-catheter-fda-510k.jpg K040869 - EXPORT CATHETER K040869 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jun 2004. https://www.510kdatabase.net/k032522/ 2004-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k032522-tecres-spacer-k-temporary-knee-fda-510k.jpg K032522 - TECRES SPACER-K TEMPORARY KNEE PROSTHESIS K032522 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared May 2004. https://www.510kdatabase.net/k033458/ 2004-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k033458-bd-phoenix-automated-microbiology-fda-510k.jpg K033458 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CONFIRMATORY ESBL TEST K033458 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared May 2004. https://www.510kdatabase.net/k033971/ 2004-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k033971-scorpio-total-knee-system-with-peri-fda-510k.jpg K033971 - SCORPIO TOTAL KNEE SYSTEM WITH PERI-APATITE COATING K033971 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared May 2004. https://www.510kdatabase.net/k040544/ 2004-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k040544-duraloc-option-acetabular-cup-system-fda-510k.jpg K040544 - DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -062 K040544 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared May 2004. https://www.510kdatabase.net/k040964/ 2004-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k040964-scorpio-total-knee-system-posterior-fda-510k.jpg K040964 - SCORPIO TOTAL KNEE SYSTEM - POSTERIOR STABILIZED TIBIAL INSERTS K040964 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared May 2004. https://www.510kdatabase.net/k041114/ 2004-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k041114-profemur-tapered-hip-stem-fda-510k.jpg K041114 - PROFEMUR TAPERED HIP STEM K041114 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared May 2004. https://www.510kdatabase.net/k041118/ 2004-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k041118-modification-to-cd-horizon-spinal-system-fda-510k.jpg K041118 - MODIFICATION TO CD HORIZON SPINAL SYSTEM K041118 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared May 2004. https://www.510kdatabase.net/k041160/ 2004-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k041160-avon-extra-small-patello-femoral-fda-510k.jpg K041160 - AVON EXTRA-SMALL PATELLO-FEMORAL REPLACEMENT K041160 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared May 2004. https://www.510kdatabase.net/k041227/ 2004-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k041227-modification-toroche-diagnostics-fda-510k.jpg K041227 - MODIFICATION TO:ROCHE DIAGNOSTICS PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA K041227 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared May 2004. https://www.510kdatabase.net/k033540/ 2004-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k033540-transxchange-support-catheter-fda-510k.jpg K033540 - TRANSXCHANGE SUPPORT CATHETER K033540 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared May 2004. https://www.510kdatabase.net/k040656/ 2004-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k040656-modification-to-smith-nephew-fda-510k.jpg K040656 - MODIFICATION TO SMITH & NEPHEW INTRAMEDULLARY HIP SCREW K040656 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared May 2004. https://www.510kdatabase.net/k040929/ 2004-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k040929-trigen-adolescent-tan-fda-510k.jpg K040929 - TRIGEN ADOLESCENT TAN K040929 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared May 2004. https://www.510kdatabase.net/k041053/ 2004-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k041053-medline-strider-micro-3-fda-510k.jpg K041053 - MEDLINE STRIDER MICRO 3 K041053 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Medline Industries, Inc.. Cleared May 2004. https://www.510kdatabase.net/k041054/ 2004-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k041054-medline-strider-maxi-3-fda-510k.jpg K041054 - MEDLINE STRIDER MAXI 3 K041054 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Medline Industries, Inc.. Cleared May 2004. https://www.510kdatabase.net/k041055/ 2004-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k041055-medline-strider-maxi-4-fda-510k.jpg K041055 - MEDLINE STRIDER MAXI 4 K041055 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Medline Industries, Inc.. Cleared May 2004. https://www.510kdatabase.net/k040378/ 2004-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k040378-kodak-directview-cr-cassettegp15-x-30-fda-510k.jpg K040378 - KODAK DIRECTVIEW CR CASSETTE/GP/15 X 30 CM, CATALOG# 8418253 K040378 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared May 2004. https://www.510kdatabase.net/k040475/ 2004-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k040475-micromax-suture-anchor-fda-510k.jpg K040475 - MICROMAX SUTURE ANCHOR K040475 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared May 2004. https://www.510kdatabase.net/k040895/ 2004-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k040895-integrity-temporary-cement-fda-510k.jpg K040895 - INTEGRITY TEMPORARY CEMENT K040895 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared May 2004. https://www.510kdatabase.net/k041046/ 2004-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k041046-maxim-accel-vanguard-ps-bearings-fda-510k.jpg K041046 - MAXIM ACCEL (VANGUARD) PS+ BEARINGS K041046 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared May 2004. https://www.510kdatabase.net/k021845/ 2004-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k021845-stardust-ii-model-1011176-fda-510k.jpg K021845 - STARDUST II, MODEL 1011176 K021845 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared May 2004. https://www.510kdatabase.net/k040442/ 2004-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k040442-protex-stabilization-system-fda-510k.jpg K040442 - PROTEX STABILIZATION SYSTEM K040442 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared May 2004. https://www.510kdatabase.net/k040859/ 2004-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k040859-heraceram-press-fda-510k.jpg K040859 - HERACERAM PRESS K040859 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared May 2004. https://www.510kdatabase.net/k040603/ 2004-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k040603-paradigm-link-blood-glucose-meter-fda-510k.jpg K040603 - PARADIGM LINK BLOOD GLUCOSE METER K040603 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Becton, Dickinson & CO. Cleared May 2004. https://www.510kdatabase.net/k040736/ 2004-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k040736-vaxcel-plus-chronic-dialysis-catheter-fda-510k.jpg K040736 - VAXCEL PLUS CHRONIC DIALYSIS CATHETER K040736 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared May 2004. https://www.510kdatabase.net/k040389/ 2004-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k040389-coonradmorrey-elbow-cement-restrictor-fda-510k.jpg K040389 - COONRAD/MORREY ELBOW CEMENT RESTRICTOR K040389 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared May 2004. https://www.510kdatabase.net/k040733/ 2004-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k040733-elecsys-troponin-t-stat-test-fda-510k.jpg K040733 - ELECSYS TROPONIN T STAT TEST K040733 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared May 2004. https://www.510kdatabase.net/k041166/ 2004-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k041166-siemens-enhanced-imaging-system-fda-510k.jpg K041166 - SIEMENS ENHANCED IMAGING SYSTEM K041166 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 2004. https://www.510kdatabase.net/k033316/ 2004-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k033316-table-tilt-device-fda-510k.jpg K033316 - TABLE TILT DEVICE K033316 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab AG. Cleared May 2004. https://www.510kdatabase.net/k040017/ 2004-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k040017-abc-caudal-and-cranial-extension-plate-fda-510k.jpg K040017 - ABC CAUDAL AND CRANIAL EXTENSION PLATE (E-PLATE) K040017 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aesculap, Inc.. Cleared May 2004. https://www.510kdatabase.net/k040174/ 2004-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k040174-bilirubin-assay-on-the-omni-s-analyzer-fda-510k.jpg K040174 - BILIRUBIN ASSAY ON THE OMNI S ANALYZER K040174 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared May 2004. https://www.510kdatabase.net/k040504/ 2004-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k040504-bardex-lubri-sil-and-lubri-sil-ic-all-fda-510k.jpg K040504 - BARDEX, LUBRI-SIL AND LUBRI-SIL IC ALL-SILICONE FOLEY CATHETERS K040504 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 2004. https://www.510kdatabase.net/k040716/ 2004-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k040716-bd-phoenix-automated-microbiology-fda-510k.jpg K040716 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PENICILLIN (GP) 0.0625-32 UG/ML K040716 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared May 2004. https://www.510kdatabase.net/k040962/ 2004-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k040962-modification-to-cd-horizon-spinal-system-fda-510k.jpg K040962 - MODIFICATION TO CD HORIZON SPINAL SYSTEM K040962 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared May 2004. https://www.510kdatabase.net/k041071/ 2004-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k041071-bd-vacutainer-trace-element-serum-plus-fda-510k.jpg K041071 - BD VACUTAINER TRACE ELEMENT SERUM PLUS TUBE AND BD VACUTAINER TRACE ELEMENT K2EDTA PLUS TUBE, MODELS 368380/368381 K041071 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Becton, Dickinson & CO. Cleared May 2004. https://www.510kdatabase.net/k040381/ 2004-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k040381-hatric-67mm-910mm-1112mm-1415mm-models-fda-510k.jpg K040381 - HATRIC, 6&7MM, 9&10MM, 11&12MM, 14&15MM, MODELS AR-13000B-07, -10, -12, -15 K040381 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared May 2004. https://www.510kdatabase.net/k040383/ 2004-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k040383-triflange-ii-acetabular-cup-system-fda-510k.jpg K040383 - TRIFLANGE II ACETABULAR CUP SYSTEM K040383 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared May 2004. https://www.510kdatabase.net/k040585/ 2004-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k040585-exactrac-40-and-exactrac-x-ray-6d-fda-510k.jpg K040585 - EXACTRAC 4.0 AND EXACTRAC X-RAY 6D K040585 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab AG. Cleared May 2004. https://www.510kdatabase.net/k033596/ 2004-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k033596-cemex-genta-bone-cement-fda-510k.jpg K033596 - CEMEX GENTA BONE CEMENT K033596 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared May 2004. https://www.510kdatabase.net/k040879/ 2004-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k040879-quantex-ferritin-fda-510k.jpg K040879 - QUANTEX FERRITIN K040879 is a FDA 510(k) cleared immunology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared May 2004. https://www.510kdatabase.net/k040588/ 2004-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k040588-synthes-usa-24-mm-lcp-wrist-plate-fda-510k.jpg K040588 - SYNTHES (USA) 2.4 MM LCP WRIST PLATE K040588 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared May 2004. https://www.510kdatabase.net/k040818/ 2004-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k040818-medline-strider-mini-3-fda-510k.jpg K040818 - MEDLINE STRIDER MINI 3 K040818 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Medline Industries, Inc.. Cleared May 2004. https://www.510kdatabase.net/k040838/ 2004-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k040838-medline-strider-mini-4-fda-510k.jpg K040838 - MEDLINE STRIDER MINI 4 K040838 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Medline Industries, Inc.. Cleared May 2004. https://www.510kdatabase.net/k033273/ 2004-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k033273-depuy-pinnacle-acetabular-cup-system-fda-510k.jpg K033273 - DEPUY PINNACLE ACETABULAR CUP SYSTEM, ESL MARATHON POLYETHYLENE LINERS, AND DEPUY ULTIMA UNIPOLAR FEMORAL HEADS K033273 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared May 2004. https://www.510kdatabase.net/k040893/ 2004-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k040893-easy-core-biopsy-system-fda-510k.jpg K040893 - EASY CORE BIOPSY SYSTEM K040893 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared May 2004. https://www.510kdatabase.net/k033670/ 2004-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k033670-gore-tri-lobe-balloon-catheter-fda-510k.jpg K033670 - GORE TRI-LOBE BALLOON CATHETER K033670 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared May 2004. https://www.510kdatabase.net/k040267/ 2004-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k040267-triathlon-cruciate-retaining-cr-total-fda-510k.jpg K040267 - TRIATHLON CRUCIATE RETAINING (CR) TOTAL KNEE K040267 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared May 2004. https://www.510kdatabase.net/k040268/ 2004-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k040268-depuy-preservation-unicondylar-tibia-fda-510k.jpg K040268 - DEPUY PRESERVATION UNICONDYLAR TIBIA K040268 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared May 2004. https://www.510kdatabase.net/k040536/ 2004-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k040536-modification-to-verte-stack-spinal-fda-510k.jpg K040536 - MODIFICATION TO VERTE-STACK SPINAL SYSTEM K040536 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared May 2004. https://www.510kdatabase.net/k040948/ 2004-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k040948-intuitive-surgical-endopass-endoscopic-fda-510k.jpg K040948 - INTUITIVE SURGICAL ENDOPASS ENDOSCOPIC DELIVERY INSTRUMENT, MODEL P/N 400170 K040948 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared May 2004. https://www.510kdatabase.net/k041010/ 2004-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k041010-remstar-auto-with-c-flex-cpap-system-fda-510k.jpg K041010 - REMSTAR AUTO WITH C-FLEX CPAP SYSTEM K041010 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared May 2004. https://www.510kdatabase.net/k040843/ 2004-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k040843-hemosil-von-willebrand-activity-fda-510k.jpg K040843 - HEMOSIL VON WILLEBRAND ACTIVITY K040843 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Apr 2004. https://www.510kdatabase.net/k040867/ 2004-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k040867-perivac-kit-models-4304-4305-4314-4315-fda-510k.jpg K040867 - PERIVAC KIT, MODELS 4304, 4305, 4314, 4315 K040867 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Apr 2004. https://www.510kdatabase.net/k022688/ 2004-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k022688-versabond-ab-bone-cement-fda-510k.jpg K022688 - VERSABOND AB BONE CEMENT K022688 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Apr 2004. https://www.510kdatabase.net/k040776/ 2004-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k040776-atlantis-sr-model-c4020-fda-510k.jpg K040776 - ATLANTIS SR, MODEL C4020 K040776 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Apr 2004. https://www.510kdatabase.net/k040803/ 2004-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k040803-ms-30-femoral-stem-standard-and-lateral-fda-510k.jpg K040803 - MS-30 FEMORAL STEM STANDARD AND LATERAL K040803 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Apr 2004. https://www.510kdatabase.net/k031457/ 2004-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k031457-endomat-lc-pump-model-20-3303-20-fda-510k.jpg K031457 - ENDOMAT LC PUMP, MODEL 20 3303 20 K031457 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Apr 2004. https://www.510kdatabase.net/k040785/ 2004-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k040785-concerto-bipolar-needle-electrode-fda-510k.jpg K040785 - CONCERTO BIPOLAR NEEDLE ELECTRODE K040785 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Boston Scientific Corp. Cleared Apr 2004. https://www.510kdatabase.net/k033611/ 2004-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k033611-calcigen-nap-bone-void-filler-fda-510k.jpg K033611 - CALCIGEN -NAP BONE VOID FILLER K033611 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Apr 2004. https://www.510kdatabase.net/k040287/ 2004-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k040287-vigilance-continuous-cardiac-fda-510k.jpg K040287 - VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/CONTINUOUS END DIASTOLIC VOLUME (CC0/SVO2/CEDV) MONITOR K040287 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Apr 2004. https://www.510kdatabase.net/k040148/ 2004-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k040148-resolution-hemostasis-clipping-device-fda-510k.jpg K040148 - RESOLUTION HEMOSTASIS CLIPPING DEVICE K040148 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Boston Scientific Corp. Cleared Apr 2004. https://www.510kdatabase.net/k040796/ 2004-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k040796-accu-chek-go-system-fda-510k.jpg K040796 - ACCU-CHEK GO SYSTEM K040796 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Apr 2004. https://www.510kdatabase.net/k034056/ 2004-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k034056-modification-to-cd-horizon-spinal-system-fda-510k.jpg K034056 - MODIFICATION TO CD HORIZON SPINAL SYSTEM K034056 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Apr 2004. https://www.510kdatabase.net/k033871/ 2004-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k033871-im-total-femur-fda-510k.jpg K033871 - IM TOTAL FEMUR K033871 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Apr 2004. https://www.510kdatabase.net/k040814/ 2004-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k040814-modification-to-precision-xtra-fda-510k.jpg K040814 - MODIFICATION TO PRECISION XTRA ADVANCED DIABETES MANAGEMENT SYSTEM K040814 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Apr 2004. https://www.510kdatabase.net/k040169/ 2004-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k040169-synthes-mandible-external-fixator-fda-510k.jpg K040169 - SYNTHES MANDIBLE EXTERNAL FIXATOR K040169 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Apr 2004. https://www.510kdatabase.net/k040331/ 2004-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k040331-smith-and-nephew-titanium-interference-fda-510k.jpg K040331 - SMITH AND NEPHEW TITANIUM INTERFERENCE SCREWS K040331 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Apr 2004. https://www.510kdatabase.net/k040444/ 2004-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k040444-ge-signa-30t-with-excite-mr-system-fda-510k.jpg K040444 - GE SIGNA 3.0T WITH EXCITE MR SYSTEM K040444 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Apr 2004. https://www.510kdatabase.net/k040342/ 2004-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k040342-interlocking-detachable-coil-system-idc-fda-510k.jpg K040342 - INTERLOCKING DETACHABLE COIL SYSTEM (IDC) K040342 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Apr 2004. https://www.510kdatabase.net/k033972/ 2004-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k033972-scorpio-total-knee-system-fda-510k.jpg K033972 - SCORPIO TOTAL KNEE SYSTEM K033972 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Apr 2004. https://www.510kdatabase.net/k040336/ 2004-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k040336-synthes-usa-lateral-entry-femoral-nail-fda-510k.jpg K040336 - SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM K040336 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Apr 2004. https://www.510kdatabase.net/k040593/ 2004-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k040593-periarticular-locking-plates-and-fda-510k.jpg K040593 - PERIARTICULAR LOCKING PLATES AND SCREWS, 2358, 2359 SERIES K040593 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Apr 2004. https://www.510kdatabase.net/k040762/ 2004-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k040762-synthes-usa-tibial-nail-system-ex-fda-510k.jpg K040762 - SYNTHES (USA) TIBIAL NAIL SYSTEM EX K040762 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Apr 2004. https://www.510kdatabase.net/k040765/ 2004-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k040765-synthes-5073-mm-cannulated-locking-fda-510k.jpg K040765 - SYNTHES 5.0/7.3 MM CANNULATED LOCKING SCREWS K040765 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Apr 2004. https://www.510kdatabase.net/k033362/ 2004-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k033362-bd-phoenix-automated-microbiology-fda-510k.jpg K033362 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM- CEFUROXIME GRAM NEGATIVE K033362 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Apr 2004. https://www.510kdatabase.net/k033907/ 2004-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k033907-bd-phoenix-automated-microbiology-fda-510k.jpg K033907 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TRIMETHOPRIM-SULFAMETHOXAZOLE 0.5/9.5 - 16/304 UG/ML K033907 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Apr 2004. https://www.510kdatabase.net/k040133/ 2004-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k040133-urine-amphetaminemethamphetamine-fda-510k.jpg K040133 - URINE AMPHETAMINE/METHAMPHETAMINE SCREEN FLEX REAGENT CARTRIDGE K040133 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Apr 2004. https://www.510kdatabase.net/k040644/ 2004-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k040644-modification-to-depuy-ceramic-femoral-fda-510k.jpg K040644 - MODIFICATION TO DEPUY CERAMIC FEMORAL HEAD K040644 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Apr 2004. https://www.510kdatabase.net/k040692/ 2004-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k040692-olympus-hdl-cholesterol-reagent-fda-510k.jpg K040692 - OLYMPUS HDL CHOLESTEROL REAGENT, OSR6195/OSR6295 AND OLYMPUS HDL CHOLESTEROL CALIBRATOR ODC0023 K040692 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus America, Inc.. Cleared Apr 2004. https://www.510kdatabase.net/k040172/ 2004-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k040172-modification-to-ge-discovery-ls-system-fda-510k.jpg K040172 - MODIFICATION TO GE DISCOVERY LS SYSTEM K040172 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Apr 2004. https://www.510kdatabase.net/k040556/ 2004-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k040556-trophypan-c-with-orthoimagingomsimaging-fda-510k.jpg K040556 - TROPHYPAN C WITH ORTHOIMAGING/OMSIMAGING ACCESSORY K040556 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Apr 2004. https://www.510kdatabase.net/k040667/ 2004-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k040667-xpert-biliary-stent-models-ex8l6006-fda-510k.jpg K040667 - XPERT BILIARY STENT, MODELS EX8L6006, EX8L3008, EX8L4008, EX8L6008, EX8S6006, EX8S3008, EX8S4008, EX8S6008 K040667 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Abbott Laboratories. Cleared Apr 2004. https://www.510kdatabase.net/k040111/ 2004-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k040111-zeus-scientific-inc-athena-multi-lyte-fda-510k.jpg K040111 - ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MPO/PR3 IGG TEST SYSTEM K040111 is a FDA 510(k) cleared immunology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Apr 2004. https://www.510kdatabase.net/k022828/ 2004-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k022828-osteoset-dbm-pellets-model-8600-48xx-fda-510k.jpg K022828 - OSTEOSET DBM PELLETS, MODEL 8600-48XX K022828 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Apr 2004. https://www.510kdatabase.net/k031601/ 2004-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k031601-microscan-synergies-plus-gram-negative-fda-510k.jpg K031601 - MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN (0.5-32 UG/ML) K031601 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Apr 2004. https://www.510kdatabase.net/k033875/ 2004-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k033875-atb-all-terrain-balloon-pta-dilatation-fda-510k.jpg K033875 - ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER K033875 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Apr 2004. https://www.510kdatabase.net/k040264/ 2004-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k040264-calibrator-for-automated-systems-fda-510k.jpg K040264 - CALIBRATOR FOR AUTOMATED SYSTEMS PROTEINS IN URINE/CSF K040264 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Apr 2004. https://www.510kdatabase.net/k040375/ 2004-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k040375-ideal-1-orthodontic-band-cement-fda-510k.jpg K040375 - IDEAL 1 ORTHODONTIC BAND CEMENT K040375 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Apr 2004. https://www.510kdatabase.net/k040665/ 2004-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k040665-somatom-sensation-64-and-sensation-fda-510k.jpg K040665 - SOMATOM SENSATION 64 AND SENSATION CARDIAC K040665 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 2004. https://www.510kdatabase.net/k033337/ 2004-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k033337-ultrapro-mesh-fda-510k.jpg K033337 - ULTRAPRO MESH K033337 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Apr 2004. https://www.510kdatabase.net/k040080/ 2004-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k040080-aesculap-absorbable-craniofix-fda-510k.jpg K040080 - AESCULAP ABSORBABLE CRANIOFIX K040080 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Mar 2004. https://www.510kdatabase.net/k040083/ 2004-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k040083-synthes-external-midface-distractor-fda-510k.jpg K040083 - SYNTHES EXTERNAL MIDFACE DISTRACTOR K040083 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Mar 2004. https://www.510kdatabase.net/k040583/ 2004-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k040583-modification-to-cd-horizon-spinal-system-fda-510k.jpg K040583 - MODIFICATION TO: CD HORIZON SPINAL SYSTEM K040583 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Mar 2004. https://www.510kdatabase.net/k040594/ 2004-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k040594-herculon-soft-tissue-reattachment-system-fda-510k.jpg K040594 - HERCULON SOFT TISSUE REATTACHMENT SYSTEM K040594 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Mar 2004. https://www.510kdatabase.net/k040635/ 2004-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k040635-carrara-interaction-ceramic-system-fda-510k.jpg K040635 - CARRARA INTERACTION CERAMIC SYSTEM K040635 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Mar 2004. https://www.510kdatabase.net/k033050/ 2004-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k033050-en-circlr-al-adjustable-loop-mapping-fda-510k.jpg K033050 - EN CIRCLR AL ADJUSTABLE LOOP MAPPING CATHETER MODELS, 1045AL1, 1045AL2, 1060AL1, 1060AL2 K033050 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Mar 2004. https://www.510kdatabase.net/k034068/ 2004-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k034068-contour-se-microspheres-fda-510k.jpg K034068 - CONTOUR SE MICROSPHERES K034068 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Mar 2004. https://www.510kdatabase.net/k040128/ 2004-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k040128-modification-to-modular-replacement-fda-510k.jpg K040128 - MODIFICATION TO MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEMS K040128 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Mar 2004. https://www.510kdatabase.net/k040517/ 2004-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k040517-tenderwet-active-fda-510k.jpg K040517 - TENDERWET ACTIVE K040517 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medline Industries, Inc.. Cleared Mar 2004. https://www.510kdatabase.net/k040568/ 2004-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k040568-polyether-urethane-material-change-in-fda-510k.jpg K040568 - POLYETHER URETHANE MATERIAL CHANGE IN NEUROSTIMULATION LEADS K040568 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Mar 2004. https://www.510kdatabase.net/k040628/ 2004-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k040628-precision-link-diabetes-data-fda-510k.jpg K040628 - PRECISION LINK DIABETES DATA MANAGEMENT SYSTEM K040628 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Mar 2004. https://www.510kdatabase.net/k040181/ 2004-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k040181-access-dhea-s-reagent-assay-fda-510k.jpg K040181 - ACCESS DHEA-S REAGENT ASSAY K040181 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Mar 2004. https://www.510kdatabase.net/k040245/ 2004-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k040245-calibrator-for-automated-systems-fda-510k.jpg K040245 - CALIBRATOR FOR AUTOMATED SYSTEMS PREALBUMIN-ASLO-CERULOPLASMIN (C.F.A.S. PAC) K040245 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Mar 2004. https://www.510kdatabase.net/k024213/ 2004-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k024213-siemens-kion-anesthesia-workstation-fda-510k.jpg K024213 - SIEMENS KION ANESTHESIA WORKSTATION - EXTENDED MODES FUNCTIONALITY, MODELS: 64 62 910 E392E, 65 22 572 E397E, 65 03 655 K024213 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2004. https://www.510kdatabase.net/k040258/ 2004-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k040258-synthes-medium-external-fixation-fda-510k.jpg K040258 - SYNTHES MEDIUM EXTERNAL FIXATION SYSTEM-MR SAFE K040258 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Mar 2004. https://www.510kdatabase.net/k040284/ 2004-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k040284-sustain-radiolucent-spacer-fda-510k.jpg K040284 - SUSTAIN RADIOLUCENT SPACER K040284 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Mar 2004. https://www.510kdatabase.net/k040462/ 2004-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k040462-trigen-trochanteric-antegrade-nail-fda-510k.jpg K040462 - TRIGEN TROCHANTERIC ANTEGRADE NAIL K040462 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Mar 2004. https://www.510kdatabase.net/k040531/ 2004-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k040531-terumo-surguard2-safety-needle-fda-510k.jpg K040531 - TERUMO SURGUARD2 SAFETY NEEDLE K040531 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terumo Medical Corp.. Cleared Mar 2004. https://www.510kdatabase.net/k033977/ 2004-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k033977-zeus-scientific-inc-athena-multi-lyte-fda-510k.jpg K033977 - ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE TPO/TG IGG TEST SYSTEM K033977 is a FDA 510(k) cleared immunology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Mar 2004. https://www.510kdatabase.net/k040541/ 2004-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k040541-mammosource-high-dose-rate-hdr-remote-fda-510k.jpg K040541 - MAMMOSOURCE HIGH DOSE RATE (HDR) REMOTE AFTERLOADER K040541 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Mar 2004. https://www.510kdatabase.net/k033389/ 2004-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k033389-powerpicc-catheters-models-3175155-fda-510k.jpg K033389 - POWERPICC CATHETERS, MODELS 3175155, 3175135 K033389 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 2004. https://www.510kdatabase.net/k040099/ 2004-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k040099-bd-phoenix-automated-microbiology-system-fda-510k.jpg K040099 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM K040099 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Mar 2004. https://www.510kdatabase.net/k040359/ 2004-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k040359-hemosil-special-test-controls-level-1-2-fda-510k.jpg K040359 - HEMOSIL SPECIAL TEST CONTROLS LEVEL 1 & 2 K040359 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Mar 2004. https://www.510kdatabase.net/k040422/ 2004-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k040422-modification-to-verte-stack-fda-510k.jpg K040422 - MODIFICATION TO VERTE-STACK K040422 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Mar 2004. https://www.510kdatabase.net/k040420/ 2004-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k040420-duceram-plus-ceramic-system-fda-510k.jpg K040420 - DUCERAM PLUS CERAMIC SYSTEM K040420 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Mar 2004. https://www.510kdatabase.net/k040421/ 2004-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k040421-duceragold-porcelains-fda-510k.jpg K040421 - DUCERAGOLD PORCELAINS K040421 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Mar 2004. https://www.510kdatabase.net/k040595/ 2004-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k040595-alice-5-fda-510k.jpg K040595 - ALICE 5 K040595 is a FDA 510(k) cleared neurology medical device. Manufacturer: Respironics, Inc.. Cleared Mar 2004. https://www.510kdatabase.net/k034012/ 2004-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k034012-smith-nephew-rf-denervation-probes-rf-fda-510k.jpg K034012 - SMITH & NEPHEW RF DENERVATION PROBES & RF CANNULAE K034012 is a FDA 510(k) cleared neurology medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Mar 2004. https://www.510kdatabase.net/k040492/ 2004-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k040492-vaxcel-plus-chronic-dialysis-catheter-fda-510k.jpg K040492 - VAXCEL PLUS CHRONIC DIALYSIS CATHETER TUNNELER K040492 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Mar 2004. https://www.510kdatabase.net/k040505/ 2004-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k040505-zilver-635-biliary-stent-fda-510k.jpg K040505 - ZILVER 635 BILIARY STENT K040505 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook, Inc.. Cleared Mar 2004. https://www.510kdatabase.net/k033893/ 2004-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k033893-spectrum-modular-system-fda-510k.jpg K033893 - SPECTRUM MODULAR SYSTEM K033893 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Mar 2004. https://www.510kdatabase.net/k040447/ 2004-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k040447-trapezoid-rx-lithotripter-compatible-fda-510k.jpg K040447 - TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET, MODELS 1086, 1087, 1088 K040447 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Mar 2004. https://www.510kdatabase.net/k033913/ 2004-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k033913-progreat-fda-510k.jpg K033913 - PROGREAT K033913 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Mar 2004. https://www.510kdatabase.net/k034028/ 2004-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k034028-ath-femoral-stem-fda-510k.jpg K034028 - ATH FEMORAL STEM K034028 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Mar 2004. https://www.510kdatabase.net/k040106/ 2004-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k040106-bd-phoenix-automated-microbiology-fda-510k.jpg K040106 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -- AMPICILLIN -- GRAM POSITIVE K040106 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Mar 2004. https://www.510kdatabase.net/k040280/ 2004-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k040280-precinorm-proteins-in-urinecsf-fda-510k.jpg K040280 - PRECINORM PROTEINS IN URINE/CSF PRECIPATH PROTEINS IN URINE/CSR CONTROLS K040280 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Mar 2004. https://www.510kdatabase.net/k040431/ 2004-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k040431-roche-diagnostics-tina-quant-igm-gen2-fda-510k.jpg K040431 - ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2 K040431 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Mar 2004. https://www.510kdatabase.net/k040434/ 2004-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k040434-roche-diagnostics-tina-quant-igg-gen2-fda-510k.jpg K040434 - ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2 K040434 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Mar 2004. https://www.510kdatabase.net/k040435/ 2004-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k040435-roche-diagnostics-tina-quant-iga-gen2-fda-510k.jpg K040435 - ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2 K040435 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Mar 2004. https://www.510kdatabase.net/k040471/ 2004-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k040471-olympus-ldl-cholesterol-reagent-fda-510k.jpg K040471 - OLYMPUS LDL CHOLESTEROL REAGENT, OSR6196/OSR6296 K040471 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus America, Inc.. Cleared Mar 2004. https://www.510kdatabase.net/k032560/ 2004-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k032560-arrowhead-spinal-system-fda-510k.jpg K032560 - ARROWHEAD SPINAL SYSTEM K032560 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Mar 2004. https://www.510kdatabase.net/k033861/ 2004-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k033861-bd-probetec-et-legionella-pneumophila-fda-510k.jpg K033861 - BD PROBETEC ET LEGIONELLA PNEUMOPHILA (LP) AMPLIFIED DNA ASSAY K033861 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Mar 2004. https://www.510kdatabase.net/k040502/ 2004-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k040502-sonoline-ebisu-diagnostic-ultrasound-fda-510k.jpg K040502 - SONOLINE EBISU DIAGNOSTIC ULTRASOUND SYSTEMS K040502 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2004. https://www.510kdatabase.net/k040160/ 2004-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k040160-quanta-plex-sle-profile-8-fda-510k.jpg K040160 - QUANTA PLEX SLE PROFILE 8 K040160 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Mar 2004. https://www.510kdatabase.net/k020895/ 2004-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k020895-allomatrix-model-86-fda-510k.jpg K020895 - ALLOMATRIX MODEL# 86 K020895 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Mar 2004. https://www.510kdatabase.net/k031100/ 2004-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k031100-synthes-ventrofix-mis-system-fda-510k.jpg K031100 - SYNTHES VENTROFIX MIS SYSTEM K031100 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Mar 2004. https://www.510kdatabase.net/k032834/ 2004-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k032834-bipap-pro-2-bi-level-system-fda-510k.jpg K032834 - BIPAP PRO 2 BI-LEVEL SYSTEM K032834 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Mar 2004. https://www.510kdatabase.net/k032733/ 2004-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k032733-pm-8000-patient-monitor-model-8000-fda-510k.jpg K032733 - PM-8000 PATIENT MONITOR, MODEL 8000 K032733 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Cleared Mar 2004. https://www.510kdatabase.net/k034066/ 2004-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k034066-bbraun-premixed-dialysate-fda-510k.jpg K034066 - B.BRAUN PREMIXED DIALYSATE K034066 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Mar 2004. https://www.510kdatabase.net/k040043/ 2004-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k040043-ndx-40-alloy-fda-510k.jpg K040043 - NDX-40 ALLOY K040043 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Mar 2004. https://www.510kdatabase.net/k033816/ 2004-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k033816-synthes-usa-modification-to-sternal-fda-510k.jpg K033816 - SYNTHES (USA) MODIFICATION TO STERNAL RECONSTRUCTION SYSTEM K033816 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Mar 2004. https://www.510kdatabase.net/k032675/ 2004-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k032675-bd-phoenix-automated-microbiology-fda-510k.jpg K032675 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFEPIME (GN) 0.5-65 UG/ML K032675 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Mar 2004. https://www.510kdatabase.net/k033814/ 2004-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k033814-bard-soft-mesh-models-0117001-0117002-fda-510k.jpg K033814 - BARD SOFT MESH, MODELS 0117001, 0117002, 0117003, 0117004, 0117005, 0117006, 0117007 K033814 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 2004. https://www.510kdatabase.net/k033948/ 2004-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k033948-microscan-dried-gram-negative-miccombo-fda-510k.jpg K033948 - MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS (GEMIFLOXACIN) K033948 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Mar 2004. https://www.510kdatabase.net/k033975/ 2004-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k033975-synthes-24-mm-titanium-ti-locking-screws-fda-510k.jpg K033975 - SYNTHES 2.4 MM TITANIUM (TI.) LOCKING SCREWS K033975 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Mar 2004. https://www.510kdatabase.net/k033995/ 2004-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k033995-35-mm-lcp-distal-humerus-system-fda-510k.jpg K033995 - 3.5 MM LCP DISTAL HUMERUS SYSTEM K033995 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Mar 2004. https://www.510kdatabase.net/k020078/ 2004-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k020078-exactech-resorbable-bone-paste-fda-510k.jpg K020078 - EXACTECH RESORBABLE BONE PASTE K020078 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Feb 2004. https://www.510kdatabase.net/k033728/ 2004-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k033728-transvaginal-endoscopy-set-fda-510k.jpg K033728 - TRANSVAGINAL ENDOSCOPY SET K033728 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Feb 2004. https://www.510kdatabase.net/k033802/ 2004-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k033802-athena-multi-lite-rheumatoid-factor-fda-510k.jpg K033802 - ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM K033802 is a FDA 510(k) cleared immunology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Feb 2004. https://www.510kdatabase.net/k040006/ 2004-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k040006-bd-phoenix-automated-microbiology-fda-510k.jpg K040006 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-LINEZOLID-GRAM POSITIVE K040006 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Feb 2004. https://www.510kdatabase.net/k040192/ 2004-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k040192-on-board-imager-device-fda-510k.jpg K040192 - ON-BOARD IMAGER DEVICE K040192 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Feb 2004. https://www.510kdatabase.net/k040275/ 2004-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k040275-lyphochek-hemostasis-control-fda-510k.jpg K040275 - LYPHOCHEK HEMOSTASIS CONTROL K040275 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bio-Rad. Cleared Feb 2004. https://www.510kdatabase.net/k032274/ 2004-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k032274-cook-five-lumen-central-venous-catheter-fda-510k.jpg K032274 - COOK FIVE LUMEN CENTRAL VENOUS CATHETER K032274 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cook, Inc.. Cleared Feb 2004. https://www.510kdatabase.net/k033395/ 2004-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k033395-codman-dural-graft-implant-models-80-fda-510k.jpg K033395 - CODMAN DURAL GRAFT IMPLANT, MODELS 80-1471, 80-1472, 80-1473, 80-1474, 80-1475, 80-1476, 80-1477, 80-1478, 80-1480, 80-1 K033395 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Feb 2004. https://www.510kdatabase.net/k033940/ 2004-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k033940-microscan-dried-gram-negative-miccombo-fda-510k.jpg K033940 - MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS-AMOXICILLIN/CLAVULANATE POTASSIUM (AUGMENTIN) K033940 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Feb 2004. https://www.510kdatabase.net/k033981/ 2004-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k033981-smith-nephew-electrothermal-20s-spine-fda-510k.jpg K033981 - SMITH & NEPHEW ELECTROTHERMAL 20S SPINE GENERATOR, MODEL 7209975 K033981 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Feb 2004. https://www.510kdatabase.net/k040157/ 2004-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k040157-elecsys-c-peptide-calcheck-fda-510k.jpg K040157 - ELECSYS C-PEPTIDE CALCHECK K040157 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Feb 2004. https://www.510kdatabase.net/k033650/ 2004-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k033650-acunav-9010-diagnostic-ultrasound-fda-510k.jpg K033650 - ACUNAV 90/10 DIAGNOSTIC ULTRASOUND CATHETER K033650 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 2004. https://www.510kdatabase.net/k040219/ 2004-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k040219-cobra-surgical-probe-fda-510k.jpg K040219 - COBRA SURGICAL PROBE K040219 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Boston Scientific Corp. Cleared Feb 2004. https://www.510kdatabase.net/k040166/ 2004-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k040166-depuy-sigma-xlk-tibial-inserts-fda-510k.jpg K040166 - DEPUY SIGMA XLK TIBIAL INSERTS K040166 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Feb 2004. https://www.510kdatabase.net/k040272/ 2004-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k040272-synthes-usa-craniofacial-plates-fda-510k.jpg K040272 - SYNTHES (USA) CRANIOFACIAL PLATES K040272 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Feb 2004. https://www.510kdatabase.net/k032394/ 2004-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k032394-stryker-spine-oasys-system-fda-510k.jpg K032394 - STRYKER SPINE OASYS SYSTEM K032394 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Feb 2004. https://www.510kdatabase.net/k033677/ 2004-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k033677-brain-perfusion-option-fda-510k.jpg K033677 - BRAIN PERFUSION OPTION K033677 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Feb 2004. https://www.510kdatabase.net/k033805/ 2004-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k033805-synthes-usa-35-45-mm-lcp-metaphyseal-fda-510k.jpg K033805 - SYNTHES (USA) 3.5 / 4.5 MM LCP METAPHYSEAL PLATES K033805 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Feb 2004. https://www.510kdatabase.net/k033809/ 2004-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k033809-dimension-lidocaine-lido-flex-reagent-fda-510k.jpg K033809 - DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG CALIBRATOR II, MODELS DF113. DC49D K033809 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Dade Behring, Inc.. Cleared Feb 2004. https://www.510kdatabase.net/k033821/ 2004-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k033821-kodak-dryview-8900-laser-imager-fda-510k.jpg K033821 - KODAK DRYVIEW 8900 LASER IMAGER MAMMOGRAPHY ACCESSORY K033821 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Feb 2004. https://www.510kdatabase.net/k033968/ 2004-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k033968-hansson-pin-system-fda-510k.jpg K033968 - HANSSON PIN SYSTEM K033968 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Feb 2004. https://www.510kdatabase.net/k040212/ 2004-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k040212-trigen-intertan-fda-510k.jpg K040212 - TRIGEN INTERTAN K040212 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Feb 2004. https://www.510kdatabase.net/k033759/ 2004-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k033759-c2-nasal-mask-fda-510k.jpg K033759 - C2 NASAL MASK K033759 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Feb 2004. https://www.510kdatabase.net/k033223/ 2004-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k033223-zimmer-ortho-guidance-systems-hip-fda-510k.jpg K033223 - ZIMMER ORTHO GUIDANCE SYSTEMS- HIP INSTRUMENTS K033223 is a FDA 510(k) cleared neurology medical device. Manufacturer: Zimmer, Inc.. Cleared Feb 2004. https://www.510kdatabase.net/k040104/ 2004-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k040104-cobra-adhere-surgical-system-model-fda-510k.jpg K040104 - COBRA ADHERE SURGICAL SYSTEM, MODEL M00415977C0 K040104 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Boston Scientific Corp. Cleared Feb 2004. https://www.510kdatabase.net/k040167/ 2004-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k040167-verte-stack-spinal-system-fda-510k.jpg K040167 - VERTE-STACK SPINAL SYSTEM K040167 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Feb 2004. https://www.510kdatabase.net/k023651/ 2004-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k023651-vectorvision-cranialent-fda-510k.jpg K023651 - VECTORVISION CRANIAL/ENT K023651 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Feb 2004. https://www.510kdatabase.net/k033909/ 2004-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k033909-wavemax-balloon-expandable-fda-510k.jpg K033909 - WAVEMAX BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM K033909 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Abbott Laboratories. Cleared Feb 2004. https://www.510kdatabase.net/k033769/ 2004-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k033769-eius-unicompartmental-knee-system-fda-510k.jpg K033769 - EIUS UNICOMPARTMENTAL KNEE SYSTEM K033769 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Feb 2004. https://www.510kdatabase.net/k033873/ 2004-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k033873-elecsys-c-peptide-calset-fda-510k.jpg K033873 - ELECSYS C-PEPTIDE CALSET K033873 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Feb 2004. https://www.510kdatabase.net/k033883/ 2004-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k033883-optetrak-total-knee-system-hi-flex-fda-510k.jpg K033883 - OPTETRAK TOTAL KNEE SYSTEM, HI-FLEX ASYMMETRIC POSTERIOR-STABILIZED CEMENTED FEMORAL COMPONENTS, HI-FLEX POSTERIOR-STABI K033883 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Feb 2004. https://www.510kdatabase.net/k034007/ 2004-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k034007-hemosil-factor-viii-deficient-plasma-fda-510k.jpg K034007 - HEMOSIL FACTOR VIII DEFICIENT PLASMA K034007 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Feb 2004. https://www.510kdatabase.net/k040097/ 2004-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k040097-medline-strider-midi-3-fda-510k.jpg K040097 - MEDLINE STRIDER MIDI 3 K040097 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Medline Industries, Inc.. Cleared Feb 2004. https://www.510kdatabase.net/k040138/ 2004-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k040138-viceroy-inflation-device-fda-510k.jpg K040138 - VICEROY INFLATION DEVICE K040138 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Feb 2004. https://www.510kdatabase.net/k040243/ 2004-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k040243-bard-atlas-pta-balloon-dilatation-fda-510k.jpg K040243 - BARD ATLAS PTA BALLOON DILATATION CATHETER K040243 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Feb 2004. https://www.510kdatabase.net/k032446/ 2004-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k032446-medline-strider-models-midi-3-and-midi-4-fda-510k.jpg K032446 - MEDLINE STRIDER, MODELS MIDI 3 AND MIDI 4 K032446 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Medline Industries, Inc.. Cleared Feb 2004. https://www.510kdatabase.net/k033011/ 2004-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k033011-zimmer-ortho-guidance-systems-knee-fda-510k.jpg K033011 - ZIMMER ORTHO GUIDANCE SYSTEMS- KNEE INSTRUMENTS K033011 is a FDA 510(k) cleared neurology medical device. Manufacturer: Zimmer, Inc.. Cleared Feb 2004. https://www.510kdatabase.net/k040066/ 2004-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k040066-siremobile-c06-fda-510k.jpg K040066 - SIREMOBILE C06 K040066 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 2004. https://www.510kdatabase.net/k040140/ 2004-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k040140-iq-guide-wire-fda-510k.jpg K040140 - IQ GUIDE WIRE K040140 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Feb 2004. https://www.510kdatabase.net/k032338/ 2004-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k032338-trio-monitor-model-0998-00-0600-fda-510k.jpg K032338 - TRIO MONITOR MODEL 0998-00-0600 K032338 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Feb 2004. https://www.510kdatabase.net/k032706/ 2004-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k032706-microscan-dried-gram-negative-miccombo-fda-510k.jpg K032706 - MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS WITH ERTAPENEM (0.002-32 MCG/ML K032706 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Feb 2004. https://www.510kdatabase.net/k033575/ 2004-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k033575-oneclick-needle-fda-510k.jpg K033575 - ONE.CLICK NEEDLE K033575 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Feb 2004. https://www.510kdatabase.net/k033713/ 2004-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k033713-urine-cocaine-metabolite-screen-flex-fda-510k.jpg K033713 - URINE COCAINE METABOLITE SCREEN FLEX REAGENT CARTRIDGE, CATALOG# DF92A K033713 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Dade Behring, Inc.. Cleared Feb 2004. https://www.510kdatabase.net/k033703/ 2004-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k033703-ideal-1-orthodontic-bracket-adhesive-fda-510k.jpg K033703 - IDEAL 1 ORTHODONTIC BRACKET ADHESIVE K033703 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Feb 2004. https://www.510kdatabase.net/k033822/ 2004-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k033822-respironics-custom-i-oral-appliance-fda-510k.jpg K033822 - RESPIRONICS CUSTOM I ORAL APPLIANCE K033822 is a FDA 510(k) cleared dental medical device. Manufacturer: Respironics, Inc.. Cleared Feb 2004. https://www.510kdatabase.net/k033823/ 2004-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k033823-respironics-custom-ii-oral-appliance-fda-510k.jpg K033823 - RESPIRONICS CUSTOM II ORAL APPLIANCE K033823 is a FDA 510(k) cleared dental medical device. Manufacturer: Respironics, Inc.. Cleared Feb 2004. https://www.510kdatabase.net/k033272/ 2004-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k033272-depuy-sigma-tibial-inserts-fda-510k.jpg K033272 - DEPUY SIGMA TIBIAL INSERTS K033272 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Feb 2004. https://www.510kdatabase.net/k033382/ 2004-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k033382-smartset-gmv-endurance-gentamicin-bone-fda-510k.jpg K033382 - SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT K033382 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Feb 2004. https://www.510kdatabase.net/k033527/ 2004-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k033527-intradyn-pediatric-hemostasis-introducer-fda-510k.jpg K033527 - INTRADYN PEDIATRIC HEMOSTASIS INTRODUCER K033527 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Feb 2004. https://www.510kdatabase.net/k033563/ 2004-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k033563-smartset-ghv-gentamicin-bone-cement-fda-510k.jpg K033563 - SMARTSET GHV GENTAMICIN BONE CEMENT K033563 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Feb 2004. https://www.510kdatabase.net/k033618/ 2004-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k033618-synthes-usa-retrogradeantegrade-fda-510k.jpg K033618 - SYNTHES (USA) RETROGRADE/ANTEGRADE FEMORAL NAIL SYSTEM K033618 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Feb 2004. https://www.510kdatabase.net/k033844/ 2004-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k033844-synthes-anterior-cervical-compression-fda-510k.jpg K033844 - SYNTHES ANTERIOR CERVICAL COMPRESSION SYSTEM K033844 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Feb 2004. https://www.510kdatabase.net/k033497/ 2004-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k033497-bard-luminexx-3-biliary-stent-and-fda-510k.jpg K033497 - BARD LUMINEXX 3 BILIARY STENT AND DELIVERY SYSTEM K033497 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Feb 2004. https://www.510kdatabase.net/k033652/ 2004-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k033652-minimally-invasive-solutions-osteotomy-fda-510k.jpg K033652 - MINIMALLY INVASIVE SOLUTIONS OSTEOTOMY GUIDE INSTRUMENT K033652 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Zimmer, Inc.. Cleared Feb 2004. https://www.510kdatabase.net/k033719/ 2004-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k033719-bard-tigertail-ureteral-catheter-fda-510k.jpg K033719 - BARD TIGERTAIL URETERAL CATHETER K033719 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Feb 2004. https://www.510kdatabase.net/k033952/ 2004-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k033952-perifix-catheter-connector-fda-510k.jpg K033952 - PERIFIX CATHETER CONNECTOR K033952 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Feb 2004. https://www.510kdatabase.net/k033036/ 2004-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k033036-br-monitor-and-br-monitor-calibrators-fda-510k.jpg K033036 - BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387620, 387647 K033036 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Feb 2004. https://www.510kdatabase.net/k033784/ 2004-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k033784-bd-phoenix-automated-microbiology-fda-510k.jpg K033784 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN 0.0625-8 UG/ML K033784 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Feb 2004. https://www.510kdatabase.net/k033889/ 2004-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k033889-bd-phoenix-automated-microbiology-fda-510k.jpg K033889 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM FOR USE WITH THE ANTIMICROBIAL AGENT CHLORAMPHENICOL 1-32 UG/ML GRAM POSITIVE K033889 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Feb 2004. https://www.510kdatabase.net/k033506/ 2004-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k033506-comprehensive-humeral-fracture-fda-510k.jpg K033506 - COMPREHENSIVE HUMERAL FRACTURE POSITIONING SLEEVE K033506 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Feb 2004. https://www.510kdatabase.net/k034061/ 2004-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k034061-modification-to-convoy-advanced-fda-510k.jpg K034061 - MODIFICATION TO CONVOY ADVANCED DELIVERY SHEATH K034061 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Jan 2004. https://www.510kdatabase.net/k033500/ 2004-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k033500-bd-careflow-central-venous-catheter-fda-510k.jpg K033500 - BD CAREFLOW CENTRAL VENOUS CATHETER K033500 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson & CO. Cleared Jan 2004. https://www.510kdatabase.net/k034058/ 2004-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k034058-spherical-tip-coronary-ostial-cannula-fda-510k.jpg K034058 - SPHERICAL TIP CORONARY OSTIAL CANNULA, MODEL 30011 K034058 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jan 2004. https://www.510kdatabase.net/k040114/ 2004-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k040114-abbott-data-port-pc-model-12181-fda-510k.jpg K040114 - ABBOTT DATA PORT PC, MODEL 12181 K040114 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Jan 2004. https://www.510kdatabase.net/k033456/ 2004-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k033456-evolve-radial-plate-fda-510k.jpg K033456 - EVOLVE RADIAL PLATE K033456 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jan 2004. https://www.510kdatabase.net/k040060/ 2004-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k040060-sonoline-g50-and-g60-s-diagnostic-fda-510k.jpg K040060 - SONOLINE G50 AND G60 S DIAGNOSTIC ULTRASOUND SYSTEMS K040060 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 2004. https://www.510kdatabase.net/k040044/ 2004-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k040044-heel-snuggler-model-99047-fda-510k.jpg K040044 - HEEL SNUGGLER, MODEL 99047 K040044 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Respironics, Inc.. Cleared Jan 2004. https://www.510kdatabase.net/k033667/ 2004-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k033667-carrara-press-system-fda-510k.jpg K033667 - CARRARA PRESS SYSTEM K033667 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jan 2004. https://www.510kdatabase.net/k031841/ 2004-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k031841-spacer-g-temporary-hip-prosthesis-fda-510k.jpg K031841 - SPACER G TEMPORARY HIP PROSTHESIS K031841 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Jan 2004. https://www.510kdatabase.net/k033908/ 2004-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k033908-n-high-sensitivity-crp-fda-510k.jpg K033908 - N HIGH SENSITIVITY CRP K033908 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Jan 2004. https://www.510kdatabase.net/k031686/ 2004-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k031686-aeromist-lt-model-hcs15004-fda-510k.jpg K031686 - AEROMIST LT, MODEL HCS15004 K031686 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Medline Industries, Inc.. Cleared Jan 2004. https://www.510kdatabase.net/k032511/ 2004-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k032511-intuition-image-fda-510k.jpg K032511 - INTUITION IMAGE K032511 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab AG. Cleared Jan 2004. https://www.510kdatabase.net/k034019/ 2004-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k034019-poly-per-q-cath-picc-catheters-fda-510k.jpg K034019 - POLY PER-Q-CATH PICC CATHETERS K034019 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 2004. https://www.510kdatabase.net/k034020/ 2004-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k034020-groshong-nxt-picc-catheters-fda-510k.jpg K034020 - GROSHONG NXT PICC CATHETERS K034020 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 2004. https://www.510kdatabase.net/k034040/ 2004-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k034040-esprit-ventilator-model-v1000-fda-510k.jpg K034040 - ESPRIT VENTILATOR, MODEL V1000 K034040 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Jan 2004. https://www.510kdatabase.net/k034055/ 2004-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k034055-immulite-2500-ck-mb-2500-myoglobin-fda-510k.jpg K034055 - IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I K034055 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jan 2004. https://www.510kdatabase.net/k033476/ 2004-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k033476-modification-to-hoffmann-ii-micro-fda-510k.jpg K033476 - MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM K033476 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jan 2004. https://www.510kdatabase.net/k040018/ 2004-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k040018-excelon-transbronchial-aspiration-fda-510k.jpg K040018 - EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412 K040018 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Boston Scientific Corp. Cleared Jan 2004. https://www.510kdatabase.net/k033363/ 2004-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k033363-zimmer-unicompartmental-knee-system-fda-510k.jpg K033363 - ZIMMER UNICOMPARTMENTAL KNEE SYSTEM K033363 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jan 2004. https://www.510kdatabase.net/k033628/ 2004-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k033628-artic-fda-510k.jpg K033628 - ARTIC K033628 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Jan 2004. https://www.510kdatabase.net/k032108/ 2004-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k032108-search-evolution-lc-total-knee-system-fda-510k.jpg K032108 - SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM (POROUS COATED) K032108 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aesculap, Inc.. Cleared Jan 2004. https://www.510kdatabase.net/k033342/ 2004-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k033342-scorpio-knee-system-tibial-inserts-fda-510k.jpg K033342 - SCORPIO KNEE SYSTEM - TIBIAL INSERTS K033342 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jan 2004. https://www.510kdatabase.net/k033890/ 2004-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k033890-advance-double-high-insert-fda-510k.jpg K033890 - ADVANCE DOUBLE HIGH INSERT K033890 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jan 2004. https://www.510kdatabase.net/k033964/ 2004-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k033964-solar-9500-information-monitor-fda-510k.jpg K033964 - SOLAR 9500 INFORMATION MONITOR K033964 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Jan 2004. https://www.510kdatabase.net/k034002/ 2004-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k034002-gamma3-nail-system-fda-510k.jpg K034002 - GAMMA3 NAIL SYSTEM K034002 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jan 2004. https://www.510kdatabase.net/k034065/ 2004-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k034065-modification-to-x-port-duo-port-fda-510k.jpg K034065 - MODIFICATION TO X-PORT DUO PORT K034065 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 2004. https://www.510kdatabase.net/k032245/ 2004-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k032245-arthrex-fibertape-tm-2mm-arthrex-fda-510k.jpg K032245 - ARTHREX FIBERTAPE (TM), 2MM, ARTHREX FIBERTAPE (TM), 3MM, ARTHREX FIBERTAPE (TM), 4MM, MODELS AR-7237, AR-7238, AR-7239 K032245 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Arthrex, Inc.. Cleared Jan 2004. https://www.510kdatabase.net/k033557/ 2004-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k033557-bd-phoenix-automated-microbiology-fda-510k.jpg K033557 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TICARCILLIN/CLAVULANATE-GRAM NEGATIVE K033557 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Jan 2004. https://www.510kdatabase.net/k033560/ 2004-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k033560-bd-phoenix-automated-microbiology-fda-510k.jpg K033560 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAZIDIME 0.5-64 UG/ML-GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS K033560 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Jan 2004. https://www.510kdatabase.net/k033936/ 2004-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k033936-bard-eliminator-pet-balloon-dilators-fda-510k.jpg K033936 - BARD ELIMINATOR PET BALLOON DILATORS K033936 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 2004. https://www.510kdatabase.net/k033289/ 2004-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k033289-modification-to-jet-x-ha-coated-half-fda-510k.jpg K033289 - MODIFICATION TO JET-X HA COATED HALF PINS K033289 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jan 2004. https://www.510kdatabase.net/k033556/ 2004-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k033556-synthes-usa-lcp-dynamic-helical-hip-fda-510k.jpg K033556 - SYNTHES (USA) LCP DYNAMIC HELICAL HIP SYSTEM K033556 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jan 2004. https://www.510kdatabase.net/k032332/ 2004-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k032332-roche-online-tdm-quinidine-fda-510k.jpg K032332 - ROCHE ONLINE TDM QUINIDINE K032332 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jan 2004. https://www.510kdatabase.net/k032334/ 2004-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k032334-roche-online-tdm-lidocaine-fda-510k.jpg K032334 - ROCHE ONLINE TDM LIDOCAINE K032334 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jan 2004. https://www.510kdatabase.net/k032361/ 2004-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k032361-endopure-root-canal-cleanser-fda-510k.jpg K032361 - ENDOPURE ROOT CANAL CLEANSER K032361 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jan 2004. https://www.510kdatabase.net/k033414/ 2004-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k033414-acl-top-model-top-fda-510k.jpg K033414 - ACL TOP MODEL, TOP K033414 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jan 2004. https://www.510kdatabase.net/k033525/ 2004-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k033525-dimension-microalbumin-malb-flex-fda-510k.jpg K033525 - DIMENSION MICROALBUMIN (MALB) FLEX REAGENT CARTRIDGE METHOD, CALIBRATOR, MODELS DF114, DC114 K033525 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Jan 2004. https://www.510kdatabase.net/k033742/ 2004-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k033742-boston-scientific-v-18-control-wire-fda-510k.jpg K033742 - BOSTON SCIENTIFIC V-18 CONTROL WIRE K033742 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Jan 2004. https://www.510kdatabase.net/k033357/ 2004-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k033357-acqsim-multislice-ct-model-453567042271-fda-510k.jpg K033357 - ACQSIM-MULTISLICE-CT, MODEL 453567042271 K033357 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Jan 2004. https://www.510kdatabase.net/k033338/ 2004-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k033338-pinnacle-revision-system-fda-510k.jpg K033338 - PINNACLE REVISION SYSTEM K033338 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jan 2004. https://www.510kdatabase.net/k033837/ 2004-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k033837-stryker-spine-vertebral-body-support-fda-510k.jpg K033837 - STRYKER SPINE VERTEBRAL BODY SUPPORT SYSTEM K033837 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jan 2004. https://www.510kdatabase.net/k033845/ 2004-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k033845-precision-xceed-diabetes-monitoring-fda-510k.jpg K033845 - PRECISION XCEED DIABETES MONITORING SYSTEM K033845 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jan 2004. https://www.510kdatabase.net/k033475/ 2004-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k033475-wireless-input-unit-model-wee-1000a-fda-510k.jpg K033475 - WIRELESS INPUT UNIT, MODEL WEE-1000A SERIES K033475 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Jan 2004. https://www.510kdatabase.net/k033937/ 2004-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k033937-elecsys-precicontrol-multianalyte-fda-510k.jpg K033937 - ELECSYS PRECICONTROL MULTIANALYTE K033937 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jan 2004. https://www.510kdatabase.net/k033775/ 2004-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k033775-hemosil-liquid-antithrombin-xl-fda-510k.jpg K033775 - HEMOSIL LIQUID ANTITHROMBIN XL K033775 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jan 2004. https://www.510kdatabase.net/k033671/ 2003-12-31 monthly 0.5 https://www.510kdatabase.net/og-image/k033671-gore-bioabsorbable-mesh-fda-510k.jpg K033671 - GORE BIOABSORBABLE MESH K033671 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Dec 2003. https://www.510kdatabase.net/k033250/ 2003-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k033250-edwards-lifesciences-vantex-central-fda-510k.jpg K033250 - EDWARDS LIFESCIENCES VANTEX CENTRAL VENOUS CATHETERS WITH THERMISTOR K033250 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Dec 2003. https://www.510kdatabase.net/k033339/ 2003-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k033339-acuity-with-conebeam-computed-tomography-fda-510k.jpg K033339 - ACUITY WITH CONEBEAM COMPUTED TOMOGRAPHY K033339 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Dec 2003. https://www.510kdatabase.net/k033665/ 2003-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k033665-venus-flow-fda-510k.jpg K033665 - VENUS FLOW K033665 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Dec 2003. https://www.510kdatabase.net/k033778/ 2003-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k033778-modification-to-bard-aquaguide-fda-510k.jpg K033778 - MODIFICATION TO BARD AQUAGUIDE URETERAL CONDUIT K033778 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 2003. https://www.510kdatabase.net/k033038/ 2003-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k033038-gi-monitor-and-gi-monitor-calibrators-fda-510k.jpg K033038 - GI MONITOR AND GI MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387687, 387688 K033038 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Dec 2003. https://www.510kdatabase.net/k033487/ 2003-12-24 monthly 0.5 https://www.510kdatabase.net/og-image/k033487-stratus-cs-acute-care-troponin-i-fda-510k.jpg K033487 - STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI K033487 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Dec 2003. https://www.510kdatabase.net/k033113/ 2003-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k033113-universal-operating-hysteriscope-set-fda-510k.jpg K033113 - UNIVERSAL OPERATING HYSTERISCOPE SET BY SOLIMA-ZUPI, CONSISTING OF OPTIC, INNER AND OUTER SHEATHS, FORCEPS, MODEL 8753 K033113 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Dec 2003. https://www.510kdatabase.net/k033343/ 2003-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k033343-trilogy-radiotherapy-delivery-system-fda-510k.jpg K033343 - TRILOGY RADIOTHERAPY DELIVERY SYSTEM K033343 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Dec 2003. https://www.510kdatabase.net/k033394/ 2003-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k033394-cordis-palmaz-genesis-transhepatic-fda-510k.jpg K033394 - CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .035 DELIVERY SYSTEM K033394 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Dec 2003. https://www.510kdatabase.net/k033629/ 2003-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k033629-versyobond-fda-510k.jpg K033629 - VERSYO.BOND K033629 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Dec 2003. https://www.510kdatabase.net/k032663/ 2003-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k032663-quantex-crp-high-sensitivity-standard-fda-510k.jpg K032663 - QUANTEX CRP HIGH SENSITIVITY STANDARD MULTIPOINT, QUANTEX CRP HIGH SENSITIVITY CONTROLS VE CONTROLS 1/2 K032663 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Dec 2003. https://www.510kdatabase.net/k033280/ 2003-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k033280-discovery-elbow-mosaic-distal-humeral-fda-510k.jpg K033280 - DISCOVERY ELBOW-MOSAIC DISTAL HUMERAL REPLACEMENT SYSTEM K033280 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Dec 2003. https://www.510kdatabase.net/k033287/ 2003-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k033287-exactrac-gating-fda-510k.jpg K033287 - EXACTRAC GATING K033287 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab AG. Cleared Dec 2003. https://www.510kdatabase.net/k033558/ 2003-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k033558-bd-phoenix-automated-microbiology-fda-510k.jpg K033558 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AZTREONAM 0.5-64 UG/ML-GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS K033558 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Dec 2003. https://www.510kdatabase.net/k033603/ 2003-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k033603-instrinsic-factor-ab-calibrators-and-fda-510k.jpg K033603 - INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 387992, 387993, 387999 K033603 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Dec 2003. https://www.510kdatabase.net/k033782/ 2003-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k033782-allegro-imaging-system-fda-510k.jpg K033782 - ALLEGRO IMAGING SYSTEM K033782 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Dec 2003. https://www.510kdatabase.net/k033867/ 2003-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k033867-ge-brainwave-options-for-mri-systems-fda-510k.jpg K033867 - GE BRAINWAVE OPTION(S) FOR MRI SYSTEMS K033867 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Dec 2003. https://www.510kdatabase.net/k031804/ 2003-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k031804-compress-distal-femoral-replacement-fda-510k.jpg K031804 - COMPRESS DISTAL FEMORAL REPLACEMENT K031804 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Dec 2003. https://www.510kdatabase.net/k033612/ 2003-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k033612-factor-ii-prothrombin-g20210a-kit-fda-510k.jpg K033612 - FACTOR II (PROTHROMBIN) G20210A KIT K033612 is a FDA 510(k) cleared pathology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Dec 2003. https://www.510kdatabase.net/k033672/ 2003-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k033672-modification-to-unity-network-id-fda-510k.jpg K033672 - MODIFICATION TO UNITY NETWORK ID K033672 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Dec 2003. https://www.510kdatabase.net/k033746/ 2003-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k033746-modified-coated-vicryl-rapide-fda-510k.jpg K033746 - MODIFIED COATED VICRYL* RAPIDE (POLYGLACTIN 910) SUTURE K033746 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Dec 2003. https://www.510kdatabase.net/k030086/ 2003-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k030086-palacos-r-bone-cement-with-gentamicin-fda-510k.jpg K030086 - PALACOS R BONE CEMENT WITH GENTAMICIN K030086 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Dec 2003. https://www.510kdatabase.net/k033734/ 2003-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k033734-lightcycler-instrument-version-12-fda-510k.jpg K033734 - LIGHTCYCLER INSTRUMENT VERSION 1.2 K033734 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Dec 2003. https://www.510kdatabase.net/den030005/ 2003-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/den030005-factor-v-leiden-kit-fda-510k.jpg DEN030005 - FACTOR V LEIDEN KIT DEN030005 is a FDA 510(k) cleared pathology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Dec 2003. https://www.510kdatabase.net/k033306/ 2003-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k033306-preciset-dat-plus-ii-and-cfas-dat-fda-510k.jpg K033306 - PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS K033306 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Dec 2003. https://www.510kdatabase.net/k033322/ 2003-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k033322-modification-to-cd-horizon-spinal-system-fda-510k.jpg K033322 - MODIFICATION TO CD HORIZON SPINAL SYSTEM K033322 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Dec 2003. https://www.510kdatabase.net/k033348/ 2003-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k033348-zilver-518-biliary-stent-fda-510k.jpg K033348 - ZILVER 518 BILIARY STENT K033348 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook, Inc.. Cleared Dec 2003. https://www.510kdatabase.net/k033631/ 2003-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k033631-modification-to-coatest-factor-viii-fda-510k.jpg K033631 - MODIFICATION TO COATEST FACTOR VIII K033631 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Dec 2003. https://www.510kdatabase.net/k033234/ 2003-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k033234-immulite-2500-automated-immunoassay-fda-510k.jpg K033234 - IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER K033234 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Dec 2003. https://www.510kdatabase.net/k033366/ 2003-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k033366-liquichek-qualitative-urine-toxicology-fda-510k.jpg K033366 - LIQUICHEK QUALITATIVE URINE TOXICOLOGY CONTROL, NEGATIVE, MODEL 454 K033366 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bio-Rad. Cleared Dec 2003. https://www.510kdatabase.net/k033404/ 2003-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k033404-liquichek-urine-toxicology-control-fda-510k.jpg K033404 - LIQUICHEK URINE TOXICOLOGY CONTROL (CONFIRMATORY SERIES) K033404 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bio-Rad. Cleared Dec 2003. https://www.510kdatabase.net/k033562/ 2003-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k033562-fastrac-gastric-access-port-kit-fda-510k.jpg K033562 - FASTRAC GASTRIC ACCESS PORT KIT K033562 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 2003. https://www.510kdatabase.net/k033583/ 2003-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k033583-progreat-fda-510k.jpg K033583 - PROGREAT K033583 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Dec 2003. https://www.510kdatabase.net/k032829/ 2003-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k032829-scorpio-low-profile-tibial-tray-fda-510k.jpg K032829 - SCORPIO LOW PROFILE TIBIAL TRAY K032829 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Dec 2003. https://www.510kdatabase.net/k033537/ 2003-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k033537-selfx-xpert-biliary-stent-models-fda-510k.jpg K033537 - SELFX XPERT BILIARY STENT, MODELS EX8L2005, EX8L3005, EX8L4005, EX8L2006, EX8L3006, EX8L4006, EX8S2005, AND EX8S3005 K033537 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Abbott Laboratories. Cleared Dec 2003. https://www.510kdatabase.net/k033669/ 2003-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k033669-smith-nephew-locking-bone-plate-system-fda-510k.jpg K033669 - SMITH & NEPHEW LOCKING BONE PLATE SYSTEM (LOCKING BONE PLATES AND SCREWS) K033669 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Dec 2003. https://www.510kdatabase.net/k033568/ 2003-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k033568-gynecare-tvt-obturator-system-fda-510k.jpg K033568 - GYNECARE TVT OBTURATOR SYSTEM K033568 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ethicon, Inc.. Cleared Dec 2003. https://www.510kdatabase.net/k033519/ 2003-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k033519-cannulated-arthrorivet-and-cannulated-fda-510k.jpg K033519 - CANNULATED ARTHRORIVET AND CANNULATED RC ARTHRORIVET K033519 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Dec 2003. https://www.510kdatabase.net/k033610/ 2003-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k033610-hdl-cholesterol-plus-2nd-generation-fda-510k.jpg K033610 - HDL-CHOLESTEROL PLUS 2ND GENERATION K033610 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Dec 2003. https://www.510kdatabase.net/k032659/ 2003-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k032659-depuy-asr-resurfacing-femoral-heads-fda-510k.jpg K032659 - DEPUY ASR RESURFACING FEMORAL HEADS K032659 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Dec 2003. https://www.510kdatabase.net/k032900/ 2003-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k032900-lifespan-reinforced-eptfe-straight-fda-510k.jpg K032900 - LIFESPAN REINFORCED EPTFE STRAIGHT VASCULAR GRAFTS, EXTERNALLY SUPPORTED VASCULAR GRAFTS, STEPPED VASCULAR GRAFTS K032900 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Dec 2003. https://www.510kdatabase.net/k033576/ 2003-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k033576-lifeshield-latex-free-primary-iv-pump-fda-510k.jpg K033576 - LIFESHIELD LATEX-FREE PRIMARY IV PUMP SET DISTAL MICROBORE PATIENT LINE, CONVERTIBLE PIN, 72 INCH, WITH 2 PRESSURE K033576 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Dec 2003. https://www.510kdatabase.net/k033516/ 2003-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k033516-depuy-global-cap-ha-resurfacing-fda-510k.jpg K033516 - DEPUY GLOBAL CAP HA RESURFACING SHOULDER HUMERAL HEADS K033516 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Dec 2003. https://www.510kdatabase.net/k033529/ 2003-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k033529-tie-in-trapezium-fda-510k.jpg K033529 - TIE-IN TRAPEZIUM K033529 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Dec 2003. https://www.510kdatabase.net/k031787/ 2003-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k031787-smith-nephew-iur-morcellation-system-fda-510k.jpg K031787 - SMITH & NEPHEW IUR MORCELLATION SYSTEM K031787 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Dec 2003. https://www.510kdatabase.net/k033246/ 2003-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k033246-preciset-dat-thc-and-preciset-dat-thc-fda-510k.jpg K033246 - PRECISET DAT THC AND PRECISET DAT THC 20 CALIBRATORS K033246 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Dec 2003. https://www.510kdatabase.net/k033387/ 2003-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k033387-quest-diagnostics-serum-chemistry-fda-510k.jpg K033387 - QUEST DIAGNOSTICS SERUM CHEMISTRY CONTROL, MODELS 935 AND 945 K033387 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Dec 2003. https://www.510kdatabase.net/k033553/ 2003-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k033553-pfz-porcelain-system-fda-510k.jpg K033553 - PFZ PORCELAIN SYSTEM K033553 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Dec 2003. https://www.510kdatabase.net/k032696/ 2003-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k032696-auto-suture-endoscopic-open-ta-fda-510k.jpg K032696 - AUTO SUTURE ENDOSCOPIC (& OPEN) TA SURGICAL STAPLER, AUTO SUTURE ENDOSCOPIC (& OPEN) GIA SURGICAL STAPLING INSTRUMENT K032696 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Dec 2003. https://www.510kdatabase.net/k032865/ 2003-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k032865-gore-seamguard-bioabsorbable-staple-fda-510k.jpg K032865 - GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL K032865 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Nov 2003. https://www.510kdatabase.net/k033509/ 2003-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k033509-modification-to-versabond-bone-cement-fda-510k.jpg K033509 - MODIFICATION TO VERSABOND BONE CEMENT K033509 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Nov 2003. https://www.510kdatabase.net/k030319/ 2003-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k030319-orthosphere-ceramic-spherical-implant-fda-510k.jpg K030319 - ORTHOSPHERE CERAMIC SPHERICAL IMPLANT K030319 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Nov 2003. https://www.510kdatabase.net/k031132/ 2003-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k031132-consultiva-case-input-station-model-fda-510k.jpg K031132 - CONSULTIVA CASE INPUT STATION, MODEL CIS-1 K031132 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Nov 2003. https://www.510kdatabase.net/k031524/ 2003-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k031524-gammamed-plus-324-hdr-remote-afterloader-fda-510k.jpg K031524 - GAMMAMED PLUS 3/24 HDR REMOTE AFTERLOADER K031524 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Nov 2003. https://www.510kdatabase.net/k033294/ 2003-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k033294-hemosplit-xk-hemosplit-xk-catheter-fda-510k.jpg K033294 - HEMOSPLIT XK, HEMOSPLIT XK CATHETER, 16FR X 42 CM, KIT K033294 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 2003. https://www.510kdatabase.net/k033411/ 2003-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k033411-synthes-usa-sterile-adjustable-distal-fda-510k.jpg K033411 - SYNTHES (USA) STERILE ADJUSTABLE DISTAL RADIUS FIXATOR (ADRF) WITH 4.0MM/3.0MM SELF-DRILLING SCHANZ SCREWS K033411 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Nov 2003. https://www.510kdatabase.net/k033442/ 2003-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k033442-reflection-constrained-liner-fda-510k.jpg K033442 - REFLECTION CONSTRAINED LINER K033442 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Nov 2003. https://www.510kdatabase.net/k033482/ 2003-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k033482-microscan-synergies-plus-gram-negative-fda-510k.jpg K033482 - MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN (0.25-128 UG/ML) K033482 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Nov 2003. https://www.510kdatabase.net/k031340/ 2003-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k031340-siemens-infinity-modular-monitors-fda-510k.jpg K031340 - SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 AND SC 9000XL, WITH SCIO K031340 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2003. https://www.510kdatabase.net/k033335/ 2003-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k033335-lithostar-modularis-with-shockwave-fda-510k.jpg K033335 - LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS K033335 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2003. https://www.510kdatabase.net/k033504/ 2003-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k033504-ge-035t-signa-ovation-with-excite-mr-fda-510k.jpg K033504 - GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM K033504 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Nov 2003. https://www.510kdatabase.net/k033492/ 2003-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k033492-modification-to-mac-5000-ecg-analysis-fda-510k.jpg K033492 - MODIFICATION TO MAC 5000 ECG ANALYSIS SYSTEM K033492 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Nov 2003. https://www.510kdatabase.net/k033548/ 2003-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k033548-roche-diagnostics-urisys-1100-urine-fda-510k.jpg K033548 - ROCHE DIAGNOSTICS URISYS 1100 URINE ANALYZER K033548 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Nov 2003. https://www.510kdatabase.net/k032665/ 2003-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k032665-olympus-lyophilized-calibrator-models-fda-510k.jpg K032665 - OLYMPUS LYOPHILIZED CALIBRATOR, MODELS DR0070 AND DR0071 K032665 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus America, Inc.. Cleared Nov 2003. https://www.510kdatabase.net/k033441/ 2003-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k033441-boston-scientific-6f-runway-guide-fda-510k.jpg K033441 - BOSTON SCIENTIFIC 6F RUNWAY GUIDE CATHETER K033441 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Nov 2003. https://www.510kdatabase.net/k030978/ 2003-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k030978-scorpio-nrg-knee-system-fda-510k.jpg K030978 - SCORPIO NRG KNEE SYSTEM K030978 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Nov 2003. https://www.510kdatabase.net/k031676/ 2003-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k031676-homechoice-apd-set-with-lineo-fda-510k.jpg K031676 - HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q K031676 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Nov 2003. https://www.510kdatabase.net/k032895/ 2003-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k032895-bi-angular-shoulder-system-fda-510k.jpg K032895 - BI-ANGULAR SHOULDER SYSTEM K032895 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Nov 2003. https://www.510kdatabase.net/k033501/ 2003-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k033501-modification-to-calibrator-for-fda-510k.jpg K033501 - MODIFICATION TO CALIBRATOR FOR AUTOMATIC SYSTEMS (CFAS) K033501 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Nov 2003. https://www.510kdatabase.net/k032869/ 2003-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k032869-cook-coda-balloon-catheter-fda-510k.jpg K032869 - COOK CODA BALLOON CATHETER K032869 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Nov 2003. https://www.510kdatabase.net/k021478/ 2003-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k021478-delta-shoulder-fda-510k.jpg K021478 - DELTA SHOULDER K021478 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Nov 2003. https://www.510kdatabase.net/k031666/ 2003-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k031666-arthrex-fiberwire-button-repair-kit-fda-510k.jpg K031666 - ARTHREX FIBERWIRE BUTTON REPAIR KIT, MODEL AR-8920DS/AR-8921DS K031666 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Nov 2003. https://www.510kdatabase.net/k033350/ 2003-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k033350-bd-vacutainer-safety-lok-fda-510k.jpg K033350 - BD VACUTAINER SAFETY-LOK ADMINISTRATION SET WITH FILTER K033350 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson & CO. Cleared Nov 2003. https://www.510kdatabase.net/k032586/ 2003-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k032586-caprosyn-absorbable-suture-fda-510k.jpg K032586 - CAPROSYN ABSORBABLE SUTURE K032586 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Nov 2003. https://www.510kdatabase.net/k030792/ 2003-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k030792-bard-endotracheal-tube-cuffed-fda-510k.jpg K030792 - BARD ENDOTRACHEAL TUBE, CUFFED K030792 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 2003. https://www.510kdatabase.net/k031175/ 2003-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k031175-clickx-monoaxial-screws-and-hooks-fda-510k.jpg K031175 - CLICK'X MONOAXIAL SCREWS AND HOOKS K031175 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Nov 2003. https://www.510kdatabase.net/k031380/ 2003-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k031380-olympus-hba1c-reagent-catalog-number-fda-510k.jpg K031380 - OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA1C CALIBRATOR, (CATOLOG NUMBER ODC3032) K031380 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus America, Inc.. Cleared Nov 2003. https://www.510kdatabase.net/k032521/ 2003-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k032521-bard-dual-lumen-ureteral-catheter-fda-510k.jpg K032521 - BARD DUAL LUMEN URETERAL CATHETER K032521 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 2003. https://www.510kdatabase.net/k033329/ 2003-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k033329-depuy-ace-universal-and-troch-entry-fda-510k.jpg K033329 - DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS K033329 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Nov 2003. https://www.510kdatabase.net/k032964/ 2003-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k032964-exactech-1214-alumina-femoral-head-fda-510k.jpg K032964 - EXACTECH 12/14 ALUMINA FEMORAL HEAD K032964 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Nov 2003. https://www.510kdatabase.net/k032646/ 2003-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k032646-elecsys-probnp-immunoassay-fda-510k.jpg K032646 - ELECSYS PROBNP IMMUNOASSAY K032646 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Nov 2003. https://www.510kdatabase.net/k032861/ 2003-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k032861-vitek-2-gram-negative-moxifloxacin-fda-510k.jpg K032861 - VITEK 2 GRAM NEGATIVE MOXIFLOXACIN K032861 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Nov 2003. https://www.510kdatabase.net/k033304/ 2003-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k033304-modification-to-dash-30004000-patient-fda-510k.jpg K033304 - MODIFICATION TO DASH 3000/4000 PATIENT MONITOR K033304 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Nov 2003. https://www.510kdatabase.net/k032475/ 2003-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k032475-somaton-computed-tomography-x-ray-fda-510k.jpg K032475 - SOMATON COMPUTED TOMOGRAPHY X-RAY SYSTEMS SLIDING GANTRY OPTION K032475 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2003. https://www.510kdatabase.net/k032536/ 2003-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k032536-somatom-extended-field-of-view-fda-510k.jpg K032536 - SOMATOM EXTENDED FIELD OF VIEW SOFTWARE OPTION K032536 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2003. https://www.510kdatabase.net/k033418/ 2003-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k033418-tsx-101aa-and-tsx-101ac-aquilion-fda-510k.jpg K033418 - TSX-101A/A AND TSX-101A/C AQUILION MULTISLICE CT SCANNERS K033418 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Nov 2003. https://www.510kdatabase.net/k032697/ 2003-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k032697-dimension-total-triiodothyronine-fda-510k.jpg K032697 - DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414) K032697 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Nov 2003. https://www.510kdatabase.net/k033245/ 2003-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k033245-bard-ultraview-multiple-band-ligator-fda-510k.jpg K033245 - BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U K033245 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 2003. https://www.510kdatabase.net/k033271/ 2003-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k033271-dynalok-classic-spinal-system-fda-510k.jpg K033271 - DYNALOK CLASSIC SPINAL SYSTEM K033271 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Nov 2003. https://www.510kdatabase.net/k033365/ 2003-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k033365-apexpro-fh-telemetry-system-fda-510k.jpg K033365 - APEXPRO FH TELEMETRY SYSTEM K033365 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Nov 2003. https://www.510kdatabase.net/k033034/ 2003-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k033034-versys-beaded-fullcoat-calcar-hip-fda-510k.jpg K033034 - VERSYS BEADED FULLCOAT CALCAR HIP PROSTHESIS K033034 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Nov 2003. https://www.510kdatabase.net/k033071/ 2003-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k033071-synthes-usa-cannulated-titanium-fda-510k.jpg K033071 - SYNTHES (USA) CANNULATED TITANIUM HUMERAL NAIL SYSTEM K033071 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Nov 2003. https://www.510kdatabase.net/k033145/ 2003-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k033145-hoffmann-ii-pelvic-clamp-fda-510k.jpg K033145 - HOFFMANN II PELVIC CLAMP K033145 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Nov 2003. https://www.510kdatabase.net/k033158/ 2003-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k033158-synthes-reprocessed-external-fixation-fda-510k.jpg K033158 - SYNTHES REPROCESSED EXTERNAL FIXATION DEVICES K033158 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Nov 2003. https://www.510kdatabase.net/k033233/ 2003-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k033233-lactosorb-tibial-l-15-screw-and-washer-fda-510k.jpg K033233 - LACTOSORB TIBIAL L-15 SCREW AND WASHER K033233 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Nov 2003. https://www.510kdatabase.net/k032788/ 2003-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k032788-vitek-2-gram-negative-gatifloxacin-fda-510k.jpg K032788 - VITEK 2 GRAM NEGATIVE GATIFLOXACIN K032788 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Nov 2003. https://www.510kdatabase.net/k031946/ 2003-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k031946-embol-x-intra-aortic-filter-extra-fda-510k.jpg K031946 - EMBOL-X INTRA-AORTIC FILTER: EXTRA-SMALL, SMALL, MEDIUM, LARGE, EXTRA-LARGE K031946 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Nov 2003. https://www.510kdatabase.net/k031963/ 2003-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k031963-conserve-plus-spiked-acetabular-shells-fda-510k.jpg K031963 - CONSERVE PLUS SPIKED ACETABULAR SHELLS AND CONSERVE TOTAL 56MM FEMORAL HEAD K031963 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Oct 2003. https://www.510kdatabase.net/k032426/ 2003-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k032426-gunhter-tulip-vena-cava-mreye-filter-fda-510k.jpg K032426 - GUNHTER TULIP VENA CAVA MREYE FILTER AND RETRIEVAL SET K032426 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Oct 2003. https://www.510kdatabase.net/k032564/ 2003-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k032564-dimension-n-acetylprocainamide-napa-fda-510k.jpg K032564 - DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111 K032564 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Oct 2003. https://www.510kdatabase.net/k032573/ 2003-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k032573-dimension-procainamide-proc-flex-fda-510k.jpg K032573 - DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110 K032573 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Oct 2003. https://www.510kdatabase.net/k032711/ 2003-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k032711-vitek-gram-negative-gatifloxacin-fda-510k.jpg K032711 - VITEK GRAM NEGATIVE GATIFLOXACIN K032711 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Oct 2003. https://www.510kdatabase.net/k032738/ 2003-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k032738-vitek-2-gram-positive-fda-510k.jpg K032738 - VITEK 2 GRAM POSITIVE QUINUPRISTIN/DALFOPRISTIN K032738 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Oct 2003. https://www.510kdatabase.net/k032766/ 2003-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k032766-vitek-2-gram-positive-linezolid-fda-510k.jpg K032766 - VITEK 2 GRAM POSITIVE LINEZOLID K032766 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Oct 2003. https://www.510kdatabase.net/k030082/ 2003-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k030082-power-control-2303-with-power-stick-m4-fda-510k.jpg K030082 - POWER CONTROL 2303 WITH POWER STICK M4, MODEL# 2303.011/.901/.911, 8564.121/.851 K030082 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Oct 2003. https://www.510kdatabase.net/k032513/ 2003-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k032513-t-wave-alternans-twa-algorithm-option-fda-510k.jpg K032513 - T-WAVE ALTERNANS (TWA) ALGORITHM OPTION K032513 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Oct 2003. https://www.510kdatabase.net/k032798/ 2003-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k032798-dimension-automated-hdl-cholesterol-fda-510k.jpg K032798 - DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48A K032798 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Oct 2003. https://www.510kdatabase.net/k032387/ 2003-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k032387-trivex-system-fda-510k.jpg K032387 - TRIVEX SYSTEM K032387 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 2003. https://www.510kdatabase.net/k033065/ 2003-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k033065-synthes-20-mm-craniofacial-locking-fda-510k.jpg K033065 - SYNTHES 2.0 MM CRANIOFACIAL LOCKING PLATES K033065 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Oct 2003. https://www.510kdatabase.net/k032403/ 2003-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k032403-smartmonitor-2-professional-series-ps-fda-510k.jpg K032403 - SMARTMONITOR 2 PROFESSIONAL SERIES (PS) K032403 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Oct 2003. https://www.510kdatabase.net/k032419/ 2003-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k032419-quantex-d-dimer-fda-510k.jpg K032419 - QUANTEX D-DIMER K032419 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Oct 2003. https://www.510kdatabase.net/k030627/ 2003-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k030627-orbiter-pv-diagnostic-electrode-fda-510k.jpg K030627 - ORBITER PV DIAGNOSTIC ELECTRODE CATHETER, MODELS 320100 & 320110 K030627 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 2003. https://www.510kdatabase.net/k032930/ 2003-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k032930-ultraflex-esophageal-ng-stent-system-fda-510k.jpg K032930 - ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM K032930 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Oct 2003. https://www.510kdatabase.net/k033139/ 2003-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k033139-ge-marlin-ultrasound-fda-510k.jpg K033139 - GE MARLIN ULTRASOUND K033139 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Oct 2003. https://www.510kdatabase.net/k032420/ 2003-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k032420-modified-coated-vicryl-plus-fda-510k.jpg K032420 - MODIFIED COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE K032420 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Oct 2003. https://www.510kdatabase.net/k032477/ 2003-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k032477-ge-logiq-book-fda-510k.jpg K032477 - GE LOGIQ BOOK K032477 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Oct 2003. https://www.510kdatabase.net/k032523/ 2003-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k032523-t2-nailing-system-fda-510k.jpg K032523 - T2 NAILING SYSTEM K032523 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Oct 2003. https://www.510kdatabase.net/k032559/ 2003-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k032559-synthes-40mm-titanium-ti-locking-screws-fda-510k.jpg K032559 - SYNTHES 4.0MM TITANIUM (TI.) LOCKING SCREWS K032559 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Oct 2003. https://www.510kdatabase.net/k032726/ 2003-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k032726-zimmer-ml-taper-hip-prosthesis-7711-fda-510k.jpg K032726 - ZIMMER M/L TAPER HIP PROSTHESIS, 7711 SERIES K032726 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Oct 2003. https://www.510kdatabase.net/k032931/ 2003-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k032931-pta-balloon-catheter-fda-510k.jpg K032931 - PTA BALLOON CATHETER K032931 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Oct 2003. https://www.510kdatabase.net/k032312/ 2003-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k032312-attain-6226def-deflectable-catheter-fda-510k.jpg K032312 - ATTAIN 6226DEF DEFLECTABLE CATHETER DELIVERY SYSTEM K032312 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Oct 2003. https://www.510kdatabase.net/k032974/ 2003-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k032974-ge-logiq-5-pro-or-expert-fda-510k.jpg K032974 - GE LOGIQ 5 PRO OR EXPERT K032974 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Oct 2003. https://www.510kdatabase.net/k033121/ 2003-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k033121-13-15mm-contourable-titanium-ti-mesh-fda-510k.jpg K033121 - 1.3 & 1.5MM CONTOURABLE TITANIUM (TI.) MESH PLATES K033121 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Oct 2003. https://www.510kdatabase.net/k032311/ 2003-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k032311-roche-diagnostics-omni-s-analyzer-fda-510k.jpg K032311 - ROCHE DIAGNOSTICS OMNI S ANALYZER K032311 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Oct 2003. https://www.510kdatabase.net/k031012/ 2003-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k031012-attest-rapid-readout-biological-fda-510k.jpg K031012 - ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO, MODEL 1294 K031012 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Oct 2003. https://www.510kdatabase.net/k031966/ 2003-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k031966-enk-fiberoptic-atomizer-set-fda-510k.jpg K031966 - ENK FIBEROPTIC ATOMIZER SET K031966 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Cook, Inc.. Cleared Oct 2003. https://www.510kdatabase.net/k032428/ 2003-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k032428-magnetom-avanto-mr-system-fda-510k.jpg K032428 - MAGNETOM AVANTO MR SYSTEM K032428 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 2003. https://www.510kdatabase.net/k033009/ 2003-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k033009-roche-diagnostics-cobas-integra-fda-510k.jpg K033009 - ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2 K033009 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Oct 2003. https://www.510kdatabase.net/k033196/ 2003-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k033196-sonoline-antares-with-clarify-ve-fda-510k.jpg K033196 - SONOLINE ANTARES WITH CLARIFY VE K033196 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 2003. https://www.510kdatabase.net/k032683/ 2003-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k032683-genesis-ii-porous-plus-ha-knee-system-fda-510k.jpg K032683 - GENESIS II POROUS PLUS HA KNEE SYSTEM K032683 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 2003. https://www.510kdatabase.net/k032926/ 2003-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k032926-ekg-speaks-fda-510k.jpg K032926 - EKG SPEAKS K032926 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Oct 2003. https://www.510kdatabase.net/k032904/ 2003-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k032904-acucam-concept-iv-fwt-model-110-0185g1-fda-510k.jpg K032904 - ACUCAM CONCEPT IV FWT, MODEL 110-0185G1 K032904 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Oct 2003. https://www.510kdatabase.net/k033165/ 2003-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k033165-preciset-dat-amphetamine-calibrators-fda-510k.jpg K033165 - PRECISET DAT AMPHETAMINE CALIBRATORS K033165 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Oct 2003. https://www.510kdatabase.net/k033185/ 2003-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k033185-cobas-integra-alp-ifcc-gen2-fda-510k.jpg K033185 - COBAS INTEGRA ALP IFCC GEN.2 K033185 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Oct 2003. https://www.510kdatabase.net/k031760/ 2003-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k031760-viewpoint-telemetry-system-fda-510k.jpg K031760 - VIEWPOINT TELEMETRY SYSTEM K031760 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Oct 2003. https://www.510kdatabase.net/k032279/ 2003-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k032279-online-tdm-amika-fda-510k.jpg K032279 - ONLINE TDM AMIKA K032279 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Oct 2003. https://www.510kdatabase.net/k032577/ 2003-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k032577-modification-to-mac-labcardiolab-fda-510k.jpg K032577 - MODIFICATION TO: MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM K032577 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Oct 2003. https://www.510kdatabase.net/k032620/ 2003-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k032620-ge-voluson-730-proexpert-bt03-fda-510k.jpg K032620 - GE VOLUSON 730 PRO/EXPERT BT03 ULTRASOUND SYSTEM K032620 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Oct 2003. https://www.510kdatabase.net/k032881/ 2003-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k032881-immuliteimmulite-1000-total-fda-510k.jpg K032881 - IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE K032881 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Oct 2003. https://www.510kdatabase.net/k033168/ 2003-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k033168-ge-02t-signa-profilei-mr-system-fda-510k.jpg K033168 - GE 0.2T SIGNA PROFILE/I MR SYSTEM K033168 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Oct 2003. https://www.510kdatabase.net/k031061/ 2003-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k031061-nexgen-porous-uncemented-femoral-and-fda-510k.jpg K031061 - NEXGEN POROUS, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS K031061 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Oct 2003. https://www.510kdatabase.net/k032138/ 2003-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k032138-medtronic-single-use-esophageal-fda-510k.jpg K032138 - MEDTRONIC SINGLE USE ESOPHAGEAL MANOMETRIC CATHETER, MEDTRONIC SINGLE USE ANORECTAL MANOMETRIC CATHETER K032138 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medtronic Vascular. Cleared Oct 2003. https://www.510kdatabase.net/k032300/ 2003-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k032300-accolade-j-hip-stem-series-fda-510k.jpg K032300 - ACCOLADE-J HIP STEM SERIES K032300 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Oct 2003. https://www.510kdatabase.net/k032581/ 2003-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k032581-global-modular-replacement-system-fda-510k.jpg K032581 - GLOBAL MODULAR REPLACEMENT SYSTEM ANTEVERTED PROMIMAL FEMORAL COMPONENT K032581 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Oct 2003. https://www.510kdatabase.net/k032898/ 2003-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k032898-t2-recon-nail-system-fda-510k.jpg K032898 - T2 RECON NAIL SYSTEM K032898 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Oct 2003. https://www.510kdatabase.net/k033160/ 2003-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k033160-synthes-sterile-low-profile-neuro-fda-510k.jpg K033160 - SYNTHES STERILE LOW PROFILE NEURO CONTOURABLE MESH PLATES K033160 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Oct 2003. https://www.510kdatabase.net/k032437/ 2003-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k032437-chemstrip-5-ob-chemstrip-7-and-fda-510k.jpg K032437 - CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS K032437 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Oct 2003. https://www.510kdatabase.net/k031263/ 2003-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k031263-3m-liquid-bandage-model-120-lb-fda-510k.jpg K031263 - 3M LIQUID BANDAGE, MODEL 120-LB K031263 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3M Company. Cleared Oct 2003. https://www.510kdatabase.net/k032098/ 2003-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k032098-arthrex-bio-compression-screw-small-fda-510k.jpg K032098 - ARTHREX BIO-COMPRESSION SCREW, SMALL, ARTHREX BIO-COMPRESSION SCREW, LARGE, MODELS AR-5024B, AR-5025B K032098 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Oct 2003. https://www.510kdatabase.net/k032458/ 2003-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k032458-abbott-architect-estradiol-calibrators-fda-510k.jpg K032458 - ABBOTT ARCHITECT ESTRADIOL CALIBRATORS K032458 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Oct 2003. https://www.510kdatabase.net/k032574/ 2003-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k032574-dimension-drug-calibrator-ii-model-dc49c-fda-510k.jpg K032574 - DIMENSION DRUG CALIBRATOR II, MODEL DC49C K032574 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Dade Behring, Inc.. Cleared Oct 2003. https://www.510kdatabase.net/k032655/ 2003-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k032655-bd-phoenix-automated-microbiology-fda-510k.jpg K032655 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFTRIAXONE 0.5-64 UG/ML K032655 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Oct 2003. https://www.510kdatabase.net/k032687/ 2003-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k032687-ace-nancy-nail-fda-510k.jpg K032687 - ACE NANCY NAIL K032687 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Oct 2003. https://www.510kdatabase.net/k032587/ 2003-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k032587-edwards-peripheral-dilatation-catheter-fda-510k.jpg K032587 - EDWARDS PERIPHERAL DILATATION CATHETER K032587 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Oct 2003. https://www.510kdatabase.net/k032712/ 2003-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k032712-vaxcel-plus-chronic-dialysis-catheter-fda-510k.jpg K032712 - VAXCEL PLUS CHRONIC DIALYSIS CATHETER K032712 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Oct 2003. https://www.510kdatabase.net/k032790/ 2003-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k032790-micromlc-fda-510k.jpg K032790 - MICROMLC K032790 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 2003. https://www.510kdatabase.net/k024133/ 2003-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k024133-cls-2000-unit-fda-510k.jpg K024133 - CLS-2000 UNIT K024133 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Dentsply Intl.. Cleared Oct 2003. https://www.510kdatabase.net/k031922/ 2003-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k031922-captiva-blood-containment-device-cn100-fda-510k.jpg K031922 - CAPTIVA BLOOD CONTAINMENT DEVICE CN100, CAN19T71W K031922 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Oct 2003. https://www.510kdatabase.net/k032144/ 2003-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k032144-perifix-catheter-connector-fda-510k.jpg K032144 - PERIFIX CATHETER CONNECTOR K032144 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Oct 2003. https://www.510kdatabase.net/k032722/ 2003-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k032722-trigen-straight-humeral-nail-system-fda-510k.jpg K032722 - TRIGEN STRAIGHT HUMERAL NAIL SYSTEM K032722 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 2003. https://www.510kdatabase.net/k032316/ 2003-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k032316-orion-e-alloy-fda-510k.jpg K032316 - ORION E ALLOY K032316 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Sep 2003. https://www.510kdatabase.net/k032317/ 2003-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k032317-orion-gx-alloy-fda-510k.jpg K032317 - ORION GX ALLOY K032317 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Sep 2003. https://www.510kdatabase.net/k022490/ 2003-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k022490-ksea-medi-pack-fda-510k.jpg K022490 - KSEA MEDI PACK K022490 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Sep 2003. https://www.510kdatabase.net/k023103/ 2003-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k023103-depuy-1-gentamicin-bone-cement-fda-510k.jpg K023103 - DEPUY 1 GENTAMICIN BONE CEMENT K023103 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Sep 2003. https://www.510kdatabase.net/k032275/ 2003-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k032275-bd-phoenix-automated-microbiology-fda-510k.jpg K032275 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-IMIPENEM 1-16 UG/ML GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS K032275 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Sep 2003. https://www.510kdatabase.net/k032151/ 2003-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k032151-depuy-sigma-tibial-inserts-and-co-cr-fda-510k.jpg K032151 - DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS K032151 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Sep 2003. https://www.510kdatabase.net/k032342/ 2003-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k032342-coulter-lh-750-hematology-analyzer-fda-510k.jpg K032342 - COULTER LH 750 HEMATOLOGY ANALYZER K032342 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Sep 2003. https://www.510kdatabase.net/k032680/ 2003-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k032680-smith-nephew-300xl-xenon-light-source-fda-510k.jpg K032680 - SMITH & NEPHEW 300XL XENON LIGHT SOURCE-HERMES READY MODEL, 7210045 K032680 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Sep 2003. https://www.510kdatabase.net/k032892/ 2003-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k032892-modification-to-trubyte-denture-base-fda-510k.jpg K032892 - MODIFICATION TO TRUBYTE DENTURE BASE RESIN SYSTEM K032892 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Sep 2003. https://www.510kdatabase.net/k032025/ 2003-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k032025-sentinol-nitinol-billary-stent-system-fda-510k.jpg K032025 - SENTINOL NITINOL BILLARY STENT SYSTEM K032025 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Sep 2003. https://www.510kdatabase.net/k031971/ 2003-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k031971-global-cap-resurfacing-replacement-fda-510k.jpg K031971 - GLOBAL CAP RESURFACING REPLACEMENT SHOULDER K031971 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Sep 2003. https://www.510kdatabase.net/k030966/ 2003-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k030966-contour-emboli-pva-and-fastracker-325-fda-510k.jpg K030966 - CONTOUR EMBOLI PVA AND FASTRACKER-325 INFUSION CATHETER K030966 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Boston Scientific Corp. Cleared Sep 2003. https://www.510kdatabase.net/k031895/ 2003-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k031895-ksea-opserver-lap-fda-510k.jpg K031895 - KSEA OPSERVER LAP K031895 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Sep 2003. https://www.510kdatabase.net/k032606/ 2003-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k032606-optetrak-total-knee-system-asymmetric-fda-510k.jpg K032606 - OPTETRAK TOTAL KNEE SYSTEM ASYMMETRIC FEMORAL COMPONENTS SIZE 6 PSOTERIOR-STABILIZING, CEMENTED FEMORAL COMPONENTS K032606 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Sep 2003. https://www.510kdatabase.net/k032707/ 2003-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k032707-contour-se-microspheres-syringe-fda-510k.jpg K032707 - CONTOUR SE MICROSPHERES (SYRINGE) K032707 is a FDA 510(k) cleared neurology medical device. Manufacturer: Boston Scientific Corp. Cleared Sep 2003. https://www.510kdatabase.net/k031280/ 2003-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k031280-ultra-drive-3-fda-510k.jpg K031280 - ULTRA-DRIVE 3 K031280 is a FDA 510(k) cleared neurology medical device. Manufacturer: Biomet, Inc.. Cleared Sep 2003. https://www.510kdatabase.net/k031945/ 2003-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k031945-arthrex-trimit-screw-model-ar-4161b-fda-510k.jpg K031945 - ARTHREX TRIMIT SCREW, MODEL AR-4161B K031945 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Sep 2003. https://www.510kdatabase.net/k032065/ 2003-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k032065-medline-band-bags-and-equipment-covers-fda-510k.jpg K032065 - MEDLINE BAND BAGS AND EQUIPMENT COVERS K032065 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Sep 2003. https://www.510kdatabase.net/k032187/ 2003-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k032187-anthrex-titanium-opening-wedge-fda-510k.jpg K032187 - ANTHREX TITANIUM OPENING WEDGE OSTEOTOMY SYSTEM K032187 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Sep 2003. https://www.510kdatabase.net/k032299/ 2003-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k032299-bd-phoenix-automated-microbiology-fda-510k.jpg K032299 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM,-AMPICILLIN 0.5.-32 UG/ML K032299 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Sep 2003. https://www.510kdatabase.net/k031902/ 2003-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k031902-online-tdm-carbamazepine-fda-510k.jpg K031902 - ONLINE TDM CARBAMAZEPINE K031902 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Sep 2003. https://www.510kdatabase.net/k031925/ 2003-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k031925-proceed-trilaminate-surgical-mesh-fda-510k.jpg K031925 - PROCEED TRILAMINATE SURGICAL MESH K031925 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Sep 2003. https://www.510kdatabase.net/k032137/ 2003-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k032137-precise-rx-nitinol-stent-transhepatic-fda-510k.jpg K032137 - PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM K032137 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Sep 2003. https://www.510kdatabase.net/k032269/ 2003-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k032269-synthes-usa-3545mm-lcp-medial-proximal-fda-510k.jpg K032269 - SYNTHES (USA) 3.5/4.5MM LCP MEDIAL PROXIMAL TIBIA PLATES K032269 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Sep 2003. https://www.510kdatabase.net/k032567/ 2003-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k032567-bd-phoenix-automated-microbiology-fda-510k.jpg K032567 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFOXITIN-GRAM NEGATIVE K032567 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Sep 2003. https://www.510kdatabase.net/k032582/ 2003-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k032582-unity-network-patient-data-server-fda-510k.jpg K032582 - UNITY NETWORK PATIENT DATA SERVER K032582 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Sep 2003. https://www.510kdatabase.net/k032611/ 2003-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k032611-lyphochek-coagulation-control-level-4-fda-510k.jpg K032611 - LYPHOCHEK COAGULATION CONTROL, LEVEL 4, MODEL 743 K032611 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bio-Rad. Cleared Sep 2003. https://www.510kdatabase.net/k031933/ 2003-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k031933-medline-reusable-surgical-gowns-100x-fda-510k.jpg K031933 - MEDLINE REUSABLE SURGICAL GOWNS (100X) K031933 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Sep 2003. https://www.510kdatabase.net/k032542/ 2003-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k032542-modification-to-contour-se-microspheres-fda-510k.jpg K032542 - MODIFICATION TO CONTOUR SE MICROSPHERES K032542 is a FDA 510(k) cleared neurology medical device. Manufacturer: Boston Scientific Corp. Cleared Sep 2003. https://www.510kdatabase.net/k032749/ 2003-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k032749-bedside-monitor-model-opv-1500-fda-510k.jpg K032749 - BEDSIDE MONITOR, MODEL OPV-1500 K032749 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Sep 2003. https://www.510kdatabase.net/k031337/ 2003-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k031337-acumen-surgical-navigation-system-fda-510k.jpg K031337 - ACUMEN SURGICAL NAVIGATION SYSTEM K031337 is a FDA 510(k) cleared neurology medical device. Manufacturer: Biomet, Inc.. Cleared Sep 2003. https://www.510kdatabase.net/k031932/ 2003-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k031932-fluoride-varnish-fda-510k.jpg K031932 - FLUORIDE VARNISH K031932 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Sep 2003. https://www.510kdatabase.net/k032033/ 2003-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k032033-cd-horizon-spinal-system-fda-510k.jpg K032033 - CD HORIZON SPINAL SYSTEM K032033 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Sep 2003. https://www.510kdatabase.net/k032163/ 2003-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k032163-duracon-total-knee-system-fda-510k.jpg K032163 - DURACON TOTAL KNEE SYSTEM K032163 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Sep 2003. https://www.510kdatabase.net/k032552/ 2003-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k032552-accu-chek-advantage-system-fda-510k.jpg K032552 - ACCU-CHEK ADVANTAGE SYSTEM K032552 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Sep 2003. https://www.510kdatabase.net/k032418/ 2003-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k032418-duracon-total-knee-system-with-peri-fda-510k.jpg K032418 - DURACON TOTAL KNEE SYSTEM WITH PERI-APATITE COATING K032418 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Sep 2003. https://www.510kdatabase.net/k032561/ 2003-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k032561-resume-ii-lead-kit-for-spinal-cord-fda-510k.jpg K032561 - RESUME II LEAD KIT FOR SPINAL CORD STIMULATION (SCS) AND PERIPHERAL NERVE STIMULATION (PNS), RESUME TL LEAD KIT FOR K032561 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Sep 2003. https://www.510kdatabase.net/k031287/ 2003-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k031287-steri-drape-surgical-drapes-fda-510k.jpg K031287 - STERI-DRAPE SURGICAL DRAPES K031287 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Sep 2003. https://www.510kdatabase.net/k032399/ 2003-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k032399-vitek-2-gram-positive-moxifloxacin-fda-510k.jpg K032399 - VITEK 2 GRAM POSITIVE MOXIFLOXACIN K032399 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Sep 2003. https://www.510kdatabase.net/k032535/ 2003-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k032535-modification-toroche-diagnostics-tina-fda-510k.jpg K032535 - MODIFICATION TO:ROCHE DIAGNOSTICS TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM K032535 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Sep 2003. https://www.510kdatabase.net/k031849/ 2003-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k031849-spectrum-patient-monitor-model-0998-00-fda-510k.jpg K031849 - SPECTRUM PATIENT MONITOR, MODEL 0998-00-0500-XXXXX K031849 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Sep 2003. https://www.510kdatabase.net/k031970/ 2003-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k031970-infinity-megacare-fda-510k.jpg K031970 - INFINITY MEGACARE K031970 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 2003. https://www.510kdatabase.net/k032528/ 2003-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k032528-bd-eclipse-bifurcated-needle-fda-510k.jpg K032528 - BD ECLIPSE BIFURCATED NEEDLE K032528 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson & CO. Cleared Sep 2003. https://www.510kdatabase.net/k032600/ 2003-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k032600-vaxcel-port-model-45-333-and-vaxcel-fda-510k.jpg K032600 - VAXCEL PORT, MODEL 45-333 AND VAXCEL W/PASV PORT, MODEL 45-233 K032600 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Boston Scientific Corp. Cleared Sep 2003. https://www.510kdatabase.net/k031377/ 2003-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k031377-sysmex-automated-coagulation-analyzer-fda-510k.jpg K031377 - SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560 K031377 is a FDA 510(k) cleared hematology medical device. Manufacturer: Dade Behring, Inc.. Cleared Sep 2003. https://www.510kdatabase.net/k031764/ 2003-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k031764-oncor-avant-garde-with-coherence-fda-510k.jpg K031764 - ONCOR AVANT-GARDE WITH COHERENCE WORKSPACES K031764 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 2003. https://www.510kdatabase.net/k031882/ 2003-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k031882-endoscopic-applicator-fda-510k.jpg K031882 - ENDOSCOPIC APPLICATOR K031882 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Baxter Healthcare Corp. Cleared Sep 2003. https://www.510kdatabase.net/k031973/ 2003-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k031973-synthes-40-mm-adjustable-clamp-for-fda-510k.jpg K031973 - SYNTHES 4.0 MM ADJUSTABLE CLAMP FOR DISTAL RADIUS FIXATOR-MR SAFE K031973 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Sep 2003. https://www.510kdatabase.net/k032038/ 2003-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k032038-pyramis-ecg-management-system-model-fda-510k.jpg K032038 - PYRAMIS ECG MANAGEMENT SYSTEM MODEL NUMBERS, 92600 AND 92601 K032038 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Sep 2003. https://www.510kdatabase.net/k032237/ 2003-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k032237-nt-protein-control-fda-510k.jpg K032237 - N/T PROTEIN CONTROL K032237 is a FDA 510(k) cleared immunology medical device. Manufacturer: Dade Behring, Inc.. Cleared Sep 2003. https://www.510kdatabase.net/k032507/ 2003-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k032507-interlok-bio-modular-humeral-stems-fda-510k.jpg K032507 - INTERLOK BIO-MODULAR HUMERAL STEMS K032507 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Sep 2003. https://www.510kdatabase.net/k032032/ 2003-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k032032-synthes-usa-lcp-proximal-femur-hook-fda-510k.jpg K032032 - SYNTHES (USA) LCP PROXIMAL FEMUR HOOK PLATES K032032 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Sep 2003. https://www.510kdatabase.net/k032037/ 2003-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k032037-cd-horizon-addition-of-spinous-process-fda-510k.jpg K032037 - CD HORIZON (ADDITION OF SPINOUS PROCESS PLATE) K032037 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Sep 2003. https://www.510kdatabase.net/k032457/ 2003-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k032457-modification-to-smart-control-nitinol-fda-510k.jpg K032457 - MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM K032457 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Sep 2003. https://www.510kdatabase.net/k032479/ 2003-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k032479-howmedica-osteonics-tibial-tray-screw-fda-510k.jpg K032479 - HOWMEDICA OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS K032479 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Sep 2003. https://www.510kdatabase.net/k030630/ 2003-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k030630-edwards-directional-catheter-fda-510k.jpg K030630 - EDWARDS DIRECTIONAL CATHETER K030630 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Sep 2003. https://www.510kdatabase.net/k031691/ 2003-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k031691-merit-mak-mini-access-kit-fda-510k.jpg K031691 - MERIT MAK (MINI ACCESS KIT) K031691 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Sep 2003. https://www.510kdatabase.net/k031761/ 2003-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k031761-synthes-usa-newsterial-orbital-plates-fda-510k.jpg K031761 - SYNTHES (USA) NEW/STERIAL ORBITAL PLATES K031761 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Sep 2003. https://www.510kdatabase.net/k031833/ 2003-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k031833-modification-to-cd-horizon-spinal-system-fda-510k.jpg K031833 - MODIFICATION TO CD HORIZON SPINAL SYSTEM K031833 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Sep 2003. https://www.510kdatabase.net/k032622/ 2003-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k032622-attain-prevail-left-heart-delivery-fda-510k.jpg K032622 - ATTAIN PREVAIL LEFT HEART DELIVERY SYSTEM MODDEL, 6228SYS K032622 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Sep 2003. https://www.510kdatabase.net/k030328/ 2003-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k030328-vidas-d-dimer-new-dd2-assay-model-30-442-fda-510k.jpg K030328 - VIDAS D-DIMER NEW (DD2) ASSAY, MODEL 30 442 K030328 is a FDA 510(k) cleared hematology medical device. Manufacturer: bioMerieux, Inc.. Cleared Sep 2003. https://www.510kdatabase.net/k031729/ 2003-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k031729-triathlon-posteriorly-stabilized-ps-fda-510k.jpg K031729 - TRIATHLON POSTERIORLY STABILIZED (PS) TOTAL KNEE SYSTEM K031729 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Sep 2003. https://www.510kdatabase.net/k031730/ 2003-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k031730-36mm-orthinox-v40-femoral-head-fda-510k.jpg K031730 - 36MM ORTHINOX V40 FEMORAL HEAD COMPONENTS K031730 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Aug 2003. https://www.510kdatabase.net/k032579/ 2003-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k032579-s2-nail-system-fda-510k.jpg K032579 - S2 NAIL SYSTEM K032579 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Aug 2003. https://www.510kdatabase.net/k031984/ 2003-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k031984-bd-phoenix-automated-microbiology-fda-510k.jpg K031984 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-TICARCILLIN-1-128 UG/ML K031984 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Aug 2003. https://www.510kdatabase.net/k032360/ 2003-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k032360-modification-to-boston-scientific-fda-510k.jpg K032360 - MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM AND EXPRESS BILIARY LD UNMOUNTED STENT K032360 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Aug 2003. https://www.510kdatabase.net/k032250/ 2003-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k032250-geoform-annuloplasty-ring-mitral-model-fda-510k.jpg K032250 - GEOFORM ANNULOPLASTY RING, MITRAL MODEL 4200 K032250 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Aug 2003. https://www.510kdatabase.net/k031637/ 2003-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k031637-innova-3100-fda-510k.jpg K031637 - INNOVA 3100 K031637 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Aug 2003. https://www.510kdatabase.net/k031657/ 2003-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k031657-stryker-spine-oasys-bone-screw-fda-510k.jpg K031657 - STRYKER SPINE OASYS BONE SCREW K031657 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Aug 2003. https://www.510kdatabase.net/k032049/ 2003-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k032049-roche-online-tdm-valproic-acid-fda-510k.jpg K032049 - ROCHE ONLINE TDM VALPROIC ACID K032049 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Aug 2003. https://www.510kdatabase.net/k032314/ 2003-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k032314-vitek-2-gram-positive-gatifloxacin-fda-510k.jpg K032314 - VITEK 2 GRAM POSITIVE GATIFLOXACIN K032314 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Aug 2003. https://www.510kdatabase.net/k030367/ 2003-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k030367-columbus-ps-fda-510k.jpg K030367 - COLUMBUS (PS) K030367 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aesculap, Inc.. Cleared Aug 2003. https://www.510kdatabase.net/k031677/ 2003-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k031677-synthes-usa-calvicle-hook-plate-fda-510k.jpg K031677 - SYNTHES (USA) CALVICLE HOOK PLATE K031677 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Aug 2003. https://www.510kdatabase.net/k032252/ 2003-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k032252-model-120-series-maternalfetal-monitor-fda-510k.jpg K032252 - MODEL 120 SERIES MATERNAL/FETAL MONITOR K032252 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Aug 2003. https://www.510kdatabase.net/k032285/ 2003-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k032285-olympus-prealbumin-calibrator-odr3029-fda-510k.jpg K032285 - OLYMPUS PREALBUMIN CALIBRATOR, ODR3029 K032285 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus America, Inc.. Cleared Aug 2003. https://www.510kdatabase.net/k032295/ 2003-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k032295-genesis-ii-posterior-stabilized-high-fda-510k.jpg K032295 - GENESIS II POSTERIOR STABILIZED HIGH FLEXION ARTICULAR INSERT K032295 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Aug 2003. https://www.510kdatabase.net/k032377/ 2003-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k032377-roche-diagnostics-hitachi-bicarbonate-fda-510k.jpg K032377 - ROCHE DIAGNOSTICS HITACHI BICARBONATE LIQUID K032377 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Aug 2003. https://www.510kdatabase.net/k032396/ 2003-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k032396-ringloc-36mm-line-and-modular-femoral-fda-510k.jpg K032396 - RINGLOC 36MM LINE AND MODULAR FEMORAL HEADS K032396 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Aug 2003. https://www.510kdatabase.net/k032490/ 2003-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k032490-toshiba-excelart-vantage-xgvagv-mri-fda-510k.jpg K032490 - TOSHIBA EXCELART VANTAGE XGV/AGV MRI DIAGNOSTIC SYSTEM, MODELS MRT-1503/P3 AND MRT-1503/P2 K032490 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Aug 2003. https://www.510kdatabase.net/k031698/ 2003-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k031698-elecys-shbg-calcheck-fda-510k.jpg K031698 - ELECYS SHBG CALCHECK K031698 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Aug 2003. https://www.510kdatabase.net/k031990/ 2003-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k031990-elecsys-precicontrol-troponin-t-fda-510k.jpg K031990 - ELECSYS PRECICONTROL TROPONIN T K031990 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Aug 2003. https://www.510kdatabase.net/k032198/ 2003-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k032198-aesculap-yasargil-aneurysm-clip-phynox-fda-510k.jpg K032198 - AESCULAP YASARGIL ANEURYSM CLIP PHYNOX BOOSTER CLIP K032198 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Aug 2003. https://www.510kdatabase.net/k032207/ 2003-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k032207-cobra-cooled-surgical-probe-model-fda-510k.jpg K032207 - COBRA COOLED SURGICAL PROBE, MODEL M004159670 K032207 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Boston Scientific Corp. Cleared Aug 2003. https://www.510kdatabase.net/k031433/ 2003-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k031433-siemens-infinity-modular-monitors-fda-510k.jpg K031433 - SIEMENS INFINITY MODULAR MONITORS, MODELS SC 7000, SC 9000XL AND SC 8000 WITH VF3 MODIFICATIONS K031433 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 2003. https://www.510kdatabase.net/k031566/ 2003-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k031566-syndeo-pca-syringe-pump-model-2l3113-fda-510k.jpg K031566 - SYNDEO PCA SYRINGE PUMP, MODEL 2L3113 K031566 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Aug 2003. https://www.510kdatabase.net/k032375/ 2003-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k032375-vaxcel-port-models-45-336-and-45-338-fda-510k.jpg K032375 - VAXCEL PORT, MODELS 45-336 AND 45-338 K032375 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Boston Scientific Corp. Cleared Aug 2003. https://www.510kdatabase.net/k032131/ 2003-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k032131-bd-automated-microbiology-system-fda-510k.jpg K032131 - BD AUTOMATED MICROBIOLOGY SYSTEM TETRACYCLINE - GP 0.5-16 UG/ML-GRAM POSITIVE ID/AST OR AST ONLY PHOENIX PANELS K032131 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Aug 2003. https://www.510kdatabase.net/k032287/ 2003-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k032287-modification-to-synchron-systems-fda-510k.jpg K032287 - MODIFICATION TO SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2 K032287 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Aug 2003. https://www.510kdatabase.net/k032168/ 2003-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k032168-gore-tex-dualmesh-emerge-plus-fda-510k.jpg K032168 - GORE-TEX DUALMESH EMERGE PLUS BIOMATERIAL K032168 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Aug 2003. https://www.510kdatabase.net/k032369/ 2003-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k032369-modification-to-apexpro-telemetry-system-fda-510k.jpg K032369 - MODIFICATION TO: APEXPRO TELEMETRY SYSTEM K032369 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Aug 2003. https://www.510kdatabase.net/k031865/ 2003-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k031865-vitek-2-gram-positive-moxifloxacin-for-fda-510k.jpg K031865 - VITEK 2 GRAM POSITIVE MOXIFLOXACIN FOR STREPOCOCCUS PNEUMONIAE K031865 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Aug 2003. https://www.510kdatabase.net/k032000/ 2003-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k032000-coulter-lh-500-hematology-analyzer-fda-510k.jpg K032000 - COULTER LH 500 HEMATOLOGY ANALYZER K032000 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Aug 2003. https://www.510kdatabase.net/k032073/ 2003-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k032073-gore-introducer-sheath-with-silicone-fda-510k.jpg K032073 - GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE K032073 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Aug 2003. https://www.510kdatabase.net/k032370/ 2003-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k032370-cic-pro-clinical-information-center-fda-510k.jpg K032370 - CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION K032370 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Aug 2003. https://www.510kdatabase.net/k030384/ 2003-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k030384-evolve-ceramic-radial-head-implant-fda-510k.jpg K030384 - EVOLVE CERAMIC RADIAL HEAD IMPLANT K030384 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Aug 2003. https://www.510kdatabase.net/k031770/ 2003-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k031770-ci-tkrukr-fda-510k.jpg K031770 - CI TKR/UKR K031770 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Aug 2003. https://www.510kdatabase.net/k032367/ 2003-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k032367-itst-intertrochanteric-subtrochanteric-fda-510k.jpg K032367 - ITST INTERTROCHANTERIC SUBTROCHANTERIC INTRAMEDULLARY FEMORAL NAIL K032367 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Aug 2003. https://www.510kdatabase.net/k030055/ 2003-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k030055-malloryhead-total-hip-system-fda-510k.jpg K030055 - MALLORY/HEAD TOTAL HIP SYSTEM K030055 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Aug 2003. https://www.510kdatabase.net/k031636/ 2003-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k031636-cs100-intra-aortic-balloon-pump-model-fda-510k.jpg K031636 - CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX K031636 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Aug 2003. https://www.510kdatabase.net/k031923/ 2003-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k031923-ultrasite-valve-fda-510k.jpg K031923 - ULTRASITE VALVE K031923 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Aug 2003. https://www.510kdatabase.net/k032265/ 2003-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k032265-cd-horizon-spinal-system-fda-510k.jpg K032265 - CD HORIZON SPINAL SYSTEM K032265 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Aug 2003. https://www.510kdatabase.net/k030369/ 2003-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k030369-opus-spinal-system-fda-510k.jpg K030369 - OPUS SPINAL SYSTEM K030369 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Aug 2003. https://www.510kdatabase.net/k031428/ 2003-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k031428-synthes-usa-large-external-fixation-fda-510k.jpg K031428 - SYNTHES (USA) LARGE EXTERNAL FIXATION CLAMPS-MR SAFE K031428 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Aug 2003. https://www.510kdatabase.net/k031654/ 2003-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k031654-synthes-resorbable-cranial-clamp-fda-510k.jpg K031654 - SYNTHES RESORBABLE CRANIAL CLAMP, (MODIFIED) K031654 is a FDA 510(k) cleared neurology medical device. Manufacturer: Synthes (Usa). Cleared Aug 2003. https://www.510kdatabase.net/k031744/ 2003-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k031744-omnifit-hfx-hip-stem-series-fda-510k.jpg K031744 - OMNIFIT HFX HIP STEM SERIES K031744 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Aug 2003. https://www.510kdatabase.net/k032017/ 2003-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k032017-liquichek-d-dimer-control-level-1-2-fda-510k.jpg K032017 - LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3 K032017 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bio-Rad. Cleared Aug 2003. https://www.510kdatabase.net/k032050/ 2003-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k032050-perivac-kit-fda-510k.jpg K032050 - PERIVAC KIT K032050 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Aug 2003. https://www.510kdatabase.net/k032097/ 2003-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k032097-depuy-ace-versanail-tibial-nail-fda-510k.jpg K032097 - DEPUY ACE VERSANAIL TIBIAL NAIL K032097 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Aug 2003. https://www.510kdatabase.net/k032162/ 2003-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k032162-access-immunoassay-system-toxo-igg-assay-fda-510k.jpg K032162 - ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY K032162 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Aug 2003. https://www.510kdatabase.net/k032197/ 2003-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k032197-twin-fix-ab-65-mm-suture-anchor-models-fda-510k.jpg K032197 - TWIN FIX AB 6.5 MM SUTURE ANCHOR, MODELS 720209, 7210210, 7210211, 7210212 K032197 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Aug 2003. https://www.510kdatabase.net/k032224/ 2003-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k032224-biorci-screw-fda-510k.jpg K032224 - BIORCI SCREW K032224 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Aug 2003. https://www.510kdatabase.net/k032244/ 2003-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k032244-gamma-3-nail-system-fda-510k.jpg K032244 - GAMMA 3 NAIL SYSTEM K032244 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Aug 2003. https://www.510kdatabase.net/k032264/ 2003-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k032264-modular-replacement-system-mrs-humeral-fda-510k.jpg K032264 - MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEM K032264 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Aug 2003. https://www.510kdatabase.net/k032339/ 2003-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k032339-cardiovations-portable-video-system-fda-510k.jpg K032339 - CARDIOVATIONS PORTABLE VIDEO SYSTEM K032339 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Aug 2003. https://www.510kdatabase.net/k032014/ 2003-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k032014-n-latex-igm-fda-510k.jpg K032014 - N LATEX IGM K032014 is a FDA 510(k) cleared immunology medical device. Manufacturer: Dade Behring, Inc.. Cleared Aug 2003. https://www.510kdatabase.net/k032035/ 2003-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k032035-synchron-lx-systems-complement-c3-c3-fda-510k.jpg K032035 - SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C4 (C4) REAGENT, SYNCHRON LX SYSTEMS CALI K032035 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Aug 2003. https://www.510kdatabase.net/k030277/ 2003-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k030277-soft-cell-dual-lumen-catheters-fda-510k.jpg K030277 - SOFT-CELL DUAL LUMEN CATHETERS K030277 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Aug 2003. https://www.510kdatabase.net/k031693/ 2003-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k031693-malloryhead-modular-calcar-with-and-fda-510k.jpg K031693 - MALLORY/HEAD MODULAR CALCAR WITH AND WITHOUT HA K031693 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Aug 2003. https://www.510kdatabase.net/k031856/ 2003-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k031856-preciset-tdm-i-and-preciset-tdm-ii-fda-510k.jpg K031856 - PRECISET TDM I AND PRECISET TDM II CALIBRATORS K031856 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Aug 2003. https://www.510kdatabase.net/k031943/ 2003-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k031943-bd-phoenix-automated-microbiology-fda-510k.jpg K031943 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEPHALOTHIN (GN) 1-64 UG/ML K031943 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Aug 2003. https://www.510kdatabase.net/k032281/ 2003-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k032281-ssa-770a-version-4-aplio-diagnostic-fda-510k.jpg K032281 - SSA-770A - VERSION 4, APLIO DIAGNOSTIC ULTRASOUND SYSTEM K032281 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Aug 2003. https://www.510kdatabase.net/k031461/ 2003-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k031461-carrier-tips-fda-510k.jpg K031461 - CARRIER TIPS K031461 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Aug 2003. https://www.510kdatabase.net/k031717/ 2003-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k031717-elecsys-shbg-immunoassay-fda-510k.jpg K031717 - ELECSYS SHBG IMMUNOASSAY K031717 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Aug 2003. https://www.510kdatabase.net/k031775/ 2003-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k031775-preciset-dat-plus-i-calibrators-fda-510k.jpg K031775 - PRECISET DAT PLUS I CALIBRATORS K031775 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Aug 2003. https://www.510kdatabase.net/k032336/ 2003-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k032336-tina-quant-crp-latex-fda-510k.jpg K032336 - TINA-QUANT CRP (LATEX) K032336 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Aug 2003. https://www.510kdatabase.net/k032346/ 2003-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k032346-unity-network-is-patient-viewer-fda-510k.jpg K032346 - UNITY NETWORK IS PATIENT VIEWER K032346 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Aug 2003. https://www.510kdatabase.net/k031561/ 2003-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k031561-cardiosoftcase-cardiac-testing-system-fda-510k.jpg K031561 - CARDIOSOFT/CASE CARDIAC TESTING SYSTEM K031561 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Aug 2003. https://www.510kdatabase.net/k032183/ 2003-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k032183-iq-hydrophilic-guide-wire-fda-510k.jpg K032183 - IQ HYDROPHILIC GUIDE WIRE K032183 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Aug 2003. https://www.510kdatabase.net/k030671/ 2003-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k030671-medtronioc-7f-launcher-biopsy-guide-fda-510k.jpg K030671 - MEDTRONIOC 7F LAUNCHER BIOPSY GUIDE CATHETER, MODEL LA7RVBB, MEDTRONIC 8F LAUNCHER BIOPSY CATHETER, MODEL LA8RVBB K030671 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jul 2003. https://www.510kdatabase.net/k031480/ 2003-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k031480-global-modular-replacement-system-fda-510k.jpg K031480 - GLOBAL MODULAR REPLACEMENT SYSTEM PEDIATRIC TIBIAL BEARING COMPONENT K031480 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jul 2003. https://www.510kdatabase.net/k031602/ 2003-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k031602-microscan-synergies-plus-gram-negative-fda-510k.jpg K031602 - MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH NITROFURANTOIN (1-256 UG/ML) K031602 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Jul 2003. https://www.510kdatabase.net/k031829/ 2003-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k031829-hemosil-factor-ix-deficient-plasma-fda-510k.jpg K031829 - HEMOSIL FACTOR IX DEFICIENT PLASMA K031829 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jul 2003. https://www.510kdatabase.net/k030268/ 2003-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k030268-niagara-temporary-dual-lumen-catheters-fda-510k.jpg K030268 - NIAGARA TEMPORARY DUAL LUMEN CATHETERS K030268 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jul 2003. https://www.510kdatabase.net/k031656/ 2003-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k031656-bipap-harmony-ventilatory-support-system-fda-510k.jpg K031656 - BIPAP HARMONY VENTILATORY SUPPORT SYSTEM K031656 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Jul 2003. https://www.510kdatabase.net/k031699/ 2003-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k031699-bd-phoenix-automated-microbiology-fda-510k.jpg K031699 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TRIMETHOPRIM-SULFAMETHOXAZOLE 0.5/9.5-16/304UG/ML K031699 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Jul 2003. https://www.510kdatabase.net/k031780/ 2003-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k031780-verte-stack-spinal-system-fda-510k.jpg K031780 - VERTE-STACK SPINAL SYSTEM K031780 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Jul 2003. https://www.510kdatabase.net/k032045/ 2003-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k032045-8-channel-cardiac-phased-array-coil-fda-510k.jpg K032045 - 8 CHANNEL CARDIAC PHASED ARRAY COIL K032045 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Jul 2003. https://www.510kdatabase.net/k032089/ 2003-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k032089-roche-diagnostics-elecsys-precicontrol-fda-510k.jpg K032089 - ROCHE DIAGNOSTICS ELECSYS PRECICONTROL CARDIAC K032089 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jul 2003. https://www.510kdatabase.net/k031969/ 2003-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k031969-depuy-restore-orthobiologic-soft-fda-510k.jpg K031969 - DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT K031969 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jul 2003. https://www.510kdatabase.net/k030766/ 2003-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k030766-oxinium-femoral-heads-fda-510k.jpg K030766 - OXINIUM FEMORAL HEADS K030766 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 2003. https://www.510kdatabase.net/k031328/ 2003-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k031328-recovery-filter-system-model-rf-048f-fda-510k.jpg K031328 - RECOVERY FILTER SYSTEM, MODEL RF-048F K031328 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jul 2003. https://www.510kdatabase.net/k031959/ 2003-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k031959-stryker-plating-system-periarticular-fda-510k.jpg K031959 - STRYKER PLATING SYSTEM PERIARTICULAR PLATES K031959 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jul 2003. https://www.510kdatabase.net/k032059/ 2003-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k032059-modification-to-macs-modular-anterior-fda-510k.jpg K032059 - MODIFICATION TO MACS MODULAR ANTERIOR CONSTRUCT SYSTEM K032059 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aesculap, Inc.. Cleared Jul 2003. https://www.510kdatabase.net/k032182/ 2003-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k032182-ge-logiq-7-model-2354858-fda-510k.jpg K032182 - GE LOGIQ 7, MODEL 2354858 K032182 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jul 2003. https://www.510kdatabase.net/k031941/ 2003-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k031941-hoffmann-ii-compact-baltimore-coupling-fda-510k.jpg K031941 - HOFFMANN II COMPACT BALTIMORE COUPLING K031941 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jul 2003. https://www.510kdatabase.net/k032013/ 2003-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k032013-coulter-act-5diff-al-hematology-analyzer-fda-510k.jpg K032013 - COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER K032013 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jul 2003. https://www.510kdatabase.net/k031512/ 2003-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k031512-emit-ii-plus-cocaine-metabolite-assay-fda-510k.jpg K031512 - EMIT II PLUS COCAINE METABOLITE ASSAY K031512 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Dade Behring, Inc.. Cleared Jul 2003. https://www.510kdatabase.net/k030442/ 2003-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k030442-catheter-repair-kit-with-replacement-fda-510k.jpg K030442 - CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 K030442 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jul 2003. https://www.510kdatabase.net/k031846/ 2003-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k031846-cardiovations-optical-bipolar-device-fda-510k.jpg K031846 - CARDIOVATIONS OPTICAL BIPOLAR DEVICE K031846 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Jul 2003. https://www.510kdatabase.net/k031847/ 2003-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k031847-cardiovations-retractor-fda-510k.jpg K031847 - CARDIOVATIONS RETRACTOR K031847 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Jul 2003. https://www.510kdatabase.net/k031912/ 2003-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k031912-bd-phoenix-automated-micrbiology-fda-510k.jpg K031912 - BD PHOENIX AUTOMATED MICRBIOLOGY SYSTEM AMOXICILLIN/CLAVUALANTE 0.5/0.25-32/16 UG/ML K031912 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Jul 2003. https://www.510kdatabase.net/k032114/ 2003-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k032114-sequoia-80-diagnostic-ultrasound-system-fda-510k.jpg K032114 - SEQUOIA 8.0 DIAGNOSTIC ULTRASOUND SYSTEM K032114 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 2003. https://www.510kdatabase.net/k031821/ 2003-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k031821-modification-to-cook-zilver-biliary-fda-510k.jpg K031821 - MODIFICATION TO COOK ZILVER BILIARY STENT K031821 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook, Inc.. Cleared Jul 2003. https://www.510kdatabase.net/k032111/ 2003-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k032111-acuson-cv70-cardiovascular-system-fda-510k.jpg K032111 - ACUSON CV70 CARDIOVASCULAR SYSTEM K032111 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 2003. https://www.510kdatabase.net/k031211/ 2003-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k031211-attain-prevail-steerable-catheter-set-fda-510k.jpg K031211 - ATTAIN PREVAIL STEERABLE CATHETER SET, MODEL 6228CTH K031211 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jul 2003. https://www.510kdatabase.net/k031247/ 2003-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k031247-cardioblate-bipolar-radiofrequency-fda-510k.jpg K031247 - CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM K031247 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medtronic Vascular. Cleared Jul 2003. https://www.510kdatabase.net/k031650/ 2003-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k031650-ferritin-generation-2-fda-510k.jpg K031650 - FERRITIN GENERATION 2 K031650 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jul 2003. https://www.510kdatabase.net/k031817/ 2003-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k031817-cellplex-tcp-synthetic-cancellous-bone-fda-510k.jpg K031817 - CELLPLEX TCP SYNTHETIC CANCELLOUS BONE K031817 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jul 2003. https://www.510kdatabase.net/k031879/ 2003-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k031879-cobas-integra-carbon-dioxide-assay-fda-510k.jpg K031879 - COBAS INTEGRA CARBON DIOXIDE ASSAY K031879 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jul 2003. https://www.510kdatabase.net/k031893/ 2003-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k031893-xia-spinal-system-and-xia-stainless-fda-510k.jpg K031893 - XIA SPINAL SYSTEM AND XIA STAINLESS STEEL SYSTEM K031893 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jul 2003. https://www.510kdatabase.net/k031376/ 2003-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k031376-dinamap-pro-1000-v3-monitor-model-1100-fda-510k.jpg K031376 - DINAMAP PRO 1000 V3 MONITOR, MODEL 1100 SERIES K031376 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Jul 2003. https://www.510kdatabase.net/k031679/ 2003-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k031679-bd-phonenix-automated-microbiology-fda-510k.jpg K031679 - BD PHONENIX AUTOMATED MICROBIOLOGY SYSTEM K031679 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Jul 2003. https://www.510kdatabase.net/k031880/ 2003-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k031880-ammoniaethanolco2-calibrator-control-fda-510k.jpg K031880 - AMMONIA/ETHANOL/CO2 CALIBRATOR, CONTROL NORMAL, CONTROL ABNORMAL K031880 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jul 2003. https://www.510kdatabase.net/k030135/ 2003-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k030135-safety-introducer-needle-fda-510k.jpg K030135 - SAFETY INTRODUCER NEEDLE K030135 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Jul 2003. https://www.510kdatabase.net/k030830/ 2003-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k030830-b-braun-nerve-block-catheter-fda-510k.jpg K030830 - B. BRAUN NERVE BLOCK CATHETER K030830 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Jul 2003. https://www.510kdatabase.net/k031145/ 2003-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k031145-estylus-electric-motor-system-fda-510k.jpg K031145 - ESTYLUS ELECTRIC MOTOR SYSTEM K031145 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jul 2003. https://www.510kdatabase.net/k031844/ 2003-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k031844-vaxcel-with-pasv-port-low-profile-fda-510k.jpg K031844 - VAXCEL WITH PASV PORT (LOW PROFILE), MODELS 45-236 AND 45-238 K031844 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Boston Scientific Corp. Cleared Jul 2003. https://www.510kdatabase.net/k031870/ 2003-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k031870-synchron-systems-valproic-acid-v-pa-fda-510k.jpg K031870 - SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT K031870 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jul 2003. https://www.510kdatabase.net/k030769/ 2003-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k030769-ultraflex-precision-colonic-stent-fda-510k.jpg K030769 - ULTRAFLEX PRECISION COLONIC STENT K030769 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Jul 2003. https://www.510kdatabase.net/k031181/ 2003-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k031181-external-fixation-systems-fda-510k.jpg K031181 - EXTERNAL FIXATION SYSTEMS K031181 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 2003. https://www.510kdatabase.net/k031203/ 2003-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k031203-biax-af-wristbiax-advanced-fixation-fda-510k.jpg K031203 - BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST K031203 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jul 2003. https://www.510kdatabase.net/k031724/ 2003-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k031724-synthes-small-cobination-clamp-mr-safe-fda-510k.jpg K031724 - SYNTHES SMALL COBINATION CLAMP-MR SAFE K031724 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jul 2003. https://www.510kdatabase.net/k031737/ 2003-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k031737-bactalert-mp-culture-bottles-plastic-fda-510k.jpg K031737 - BACT/ALERT MP CULTURE BOTTLES (PLASTIC) K031737 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jul 2003. https://www.510kdatabase.net/k032008/ 2003-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k032008-vaxcel-with-pasv-port-model-45-213-fda-510k.jpg K032008 - VAXCEL WITH PASV PORT, MODEL 45-213 K032008 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Boston Scientific Corp. Cleared Jul 2003. https://www.510kdatabase.net/k030841/ 2003-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k030841-cook-gastric-sizing-balloon-catheter-fda-510k.jpg K030841 - COOK GASTRIC SIZING BALLOON CATHETER K030841 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook, Inc.. Cleared Jul 2003. https://www.510kdatabase.net/k031589/ 2003-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k031589-bd-phoenix-automated-microbiology-fda-510k.jpg K031589 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN GRAM POSITIVE K031589 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Jul 2003. https://www.510kdatabase.net/k032036/ 2003-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k032036-gemini-16-fda-510k.jpg K032036 - GEMINI 16 K032036 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Jul 2003. https://www.510kdatabase.net/k031410/ 2003-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k031410-vitek-2-gram-positive-linezolid-for-fda-510k.jpg K031410 - VITEK 2 GRAM POSITIVE LINEZOLID FOR STREPTOCOCCUS PNEUMONIAE K031410 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jul 2003. https://www.510kdatabase.net/k031530/ 2003-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k031530-bd-phoenix-automated-microbiology-fda-510k.jpg K031530 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN-8-512 UG/ML K031530 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Jul 2003. https://www.510kdatabase.net/k032044/ 2003-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k032044-x-prot-duo-port-fda-510k.jpg K032044 - X-PROT DUO PORT K032044 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jul 2003. https://www.510kdatabase.net/k031824/ 2003-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k031824-cobas-integra-cholesterol-gen-2-fda-510k.jpg K031824 - COBAS INTEGRA CHOLESTEROL GEN. 2 K031824 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jul 2003. https://www.510kdatabase.net/k031453/ 2003-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k031453-terumo-surguard-2-safety-needle-fda-510k.jpg K031453 - TERUMO SURGUARD 2 SAFETY NEEDLE K031453 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terumo Medical Corp.. Cleared Jul 2003. https://www.510kdatabase.net/k031555/ 2003-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k031555-synthes-usa-compartmental-pressure-fda-510k.jpg K031555 - SYNTHES (USA) COMPARTMENTAL PRESSURE MONITORING SYSTEM K031555 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jul 2003. https://www.510kdatabase.net/k031777/ 2003-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k031777-modeification-to-smart-control-nitinol-fda-510k.jpg K031777 - MODEIFICATION TO: SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM K031777 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Jul 2003. https://www.510kdatabase.net/k024303/ 2003-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k024303-edwards-lifesciences-lifestent-nt18-fda-510k.jpg K024303 - EDWARDS LIFESCIENCES LIFESTENT NT18 SELF-EXPANDING BILIARY STENT AND DELIVERY SYSTEM K024303 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Jul 2003. https://www.510kdatabase.net/k031755/ 2003-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k031755-accu-chek-compact-test-strip-fda-510k.jpg K031755 - ACCU-CHEK COMPACT TEST STRIP K031755 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jul 2003. https://www.510kdatabase.net/k031843/ 2003-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k031843-modification-to-evencare-blood-glucose-fda-510k.jpg K031843 - MODIFICATION TO EVENCARE BLOOD GLUCOSE MONITORING SYSTEM K031843 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Medline Industries, Inc.. Cleared Jul 2003. https://www.510kdatabase.net/k030899/ 2003-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k030899-c-reactive-protein-crp-fda-510k.jpg K030899 - C-REACTIVE PROTEIN (CRP) K030899 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jul 2003. https://www.510kdatabase.net/k031276/ 2003-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k031276-synthes-anterior-cervical-locking-fda-510k.jpg K031276 - SYNTHES ANTERIOR CERVICAL LOCKING PLATE (ACLP) SYSTEM K031276 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jul 2003. https://www.510kdatabase.net/k031807/ 2003-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k031807-synthes-low-profile-neuro-system-3-mm-fda-510k.jpg K031807 - SYNTHES LOW PROFILE NEURO SYSTEM - 3 MM SCREWS K031807 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Jul 2003. https://www.510kdatabase.net/k031927/ 2003-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k031927-ge-delta-software-option-for-mri-fda-510k.jpg K031927 - GE DELTA SOFTWARE OPTION FOR MRI K031927 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Jul 2003. https://www.510kdatabase.net/k031685/ 2003-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k031685-tag-rod-bioraptor-suture-anchor-fda-510k.jpg K031685 - TAG ROD BIORAPTOR SUTURE ANCHOR 7209317, 7209318 K031685 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 2003. https://www.510kdatabase.net/k031734/ 2003-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k031734-generation-4-polished-femoral-hip-fda-510k.jpg K031734 - GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS K031734 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jul 2003. https://www.510kdatabase.net/k031803/ 2003-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k031803-depuy-ceramic-femoral-heads-fda-510k.jpg K031803 - DEPUY CERAMIC FEMORAL HEADS K031803 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jul 2003. https://www.510kdatabase.net/k031302/ 2003-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k031302-sustain-spacer-fda-510k.jpg K031302 - SUSTAIN SPACER K031302 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Globus Medical, Inc.. Cleared Jun 2003. https://www.510kdatabase.net/k031538/ 2003-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k031538-endovive-initial-placement-peg-kit-fda-510k.jpg K031538 - ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT K031538 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Jun 2003. https://www.510kdatabase.net/k031655/ 2003-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k031655-cd-horizon-spinal-system-fda-510k.jpg K031655 - CD HORIZON SPINAL SYSTEM K031655 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Jun 2003. https://www.510kdatabase.net/k031888/ 2003-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k031888-modification-to-cd-horizon-spinal-system-fda-510k.jpg K031888 - MODIFICATION TO CD HORIZON SPINAL SYSTEM K031888 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Jun 2003. https://www.510kdatabase.net/k031766/ 2003-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k031766-atb-all-terrain-balloon-pta-dilatation-fda-510k.jpg K031766 - ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER K031766 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Jun 2003. https://www.510kdatabase.net/k031450/ 2003-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k031450-quanta-plex-ena-profile-6-fda-510k.jpg K031450 - QUANTA PLEX ENA PROFILE 6 K031450 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Jun 2003. https://www.510kdatabase.net/k031756/ 2003-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k031756-roche-diagnostics-elecsys-folate-ii-fda-510k.jpg K031756 - ROCHE DIAGNOSTICS ELECSYS FOLATE II ASSAY K031756 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jun 2003. https://www.510kdatabase.net/k023955/ 2003-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k023955-bd-viper-instrument-fda-510k.jpg K023955 - BD VIPER INSTRUMENT K023955 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Jun 2003. https://www.510kdatabase.net/k030981/ 2003-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k030981-eclipse-fda-510k.jpg K030981 - ECLIPSE K030981 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Jun 2003. https://www.510kdatabase.net/k031200/ 2003-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k031200-modification-to-bd-ultra-fine-iii-pen-fda-510k.jpg K031200 - MODIFICATION TO BD ULTRA-FINE III PEN NEEDLE K031200 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson & CO. Cleared Jun 2003. https://www.510kdatabase.net/k031460/ 2003-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k031460-modification-to-remstar-auto-cpap-system-fda-510k.jpg K031460 - MODIFICATION TO REMSTAR AUTO CPAP SYSTEM K031460 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Jun 2003. https://www.510kdatabase.net/k031572/ 2003-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k031572-zmr-hip-system-xl-models-9921-9922-and-fda-510k.jpg K031572 - ZMR HIP SYSTEM-XL, MODELS 9921, 9922 AND 9923 K031572 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jun 2003. https://www.510kdatabase.net/k031725/ 2003-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k031725-synthes-ti-15-mo-locking-distal-radius-fda-510k.jpg K031725 - SYNTHES TI-15 MO LOCKING DISTAL RADIUS PLATING SYSTEM K031725 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jun 2003. https://www.510kdatabase.net/k030944/ 2003-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k030944-edwards-lifesciences-percutaneous-fda-510k.jpg K030944 - EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL K030944 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Jun 2003. https://www.510kdatabase.net/k031095/ 2003-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k031095-sense-body-coil-fda-510k.jpg K031095 - SENSE BODY COIL K031095 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Jun 2003. https://www.510kdatabase.net/k031606/ 2003-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k031606-access-immunoassay-system-rubella-igg-fda-510k.jpg K031606 - ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY K031606 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jun 2003. https://www.510kdatabase.net/k031675/ 2003-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k031675-smith-nephew-dyonics-electroblade-fda-510k.jpg K031675 - SMITH & NEPHEW DYONICS ELECTROBLADE RESECTOR K031675 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jun 2003. https://www.510kdatabase.net/k031231/ 2003-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k031231-liquicheck-urinalysis-control-bilevel-fda-510k.jpg K031231 - LIQUICHECK URINALYSIS CONTROL BILEVEL, MODEL 435, LIQUICHEK URINALYSIS CONTROL LEVEL 2, MODEL 436, LIQUICHEK URINALYSIS K031231 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Jun 2003. https://www.510kdatabase.net/k031605/ 2003-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k031605-intelijet-fluid-management-system-fda-510k.jpg K031605 - INTELIJET FLUID MANAGEMENT SYSTEM HERMES-READY K031605 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jun 2003. https://www.510kdatabase.net/k030099/ 2003-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k030099-baxter-arena-hemodialysis-delivery-fda-510k.jpg K030099 - BAXTER ARENA HEMODIALYSIS DELIVERY SYSTEM, MODEL 1571278000 K030099 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jun 2003. https://www.510kdatabase.net/k030020/ 2003-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k030020-hemosplit-long-term-hemodialysis-fda-510k.jpg K030020 - HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER K030020 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jun 2003. https://www.510kdatabase.net/k030950/ 2003-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k030950-vidas-troponin-i-tni-model-30-445-fda-510k.jpg K030950 - VIDAS TROPONIN I (TNI), MODEL 30 445 K030950 is a FDA 510(k) cleared chemistry medical device. Manufacturer: bioMerieux, Inc.. Cleared Jun 2003. https://www.510kdatabase.net/k031197/ 2003-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k031197-modification-to-smart-control-nitinol-fda-510k.jpg K031197 - MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM K031197 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Jun 2003. https://www.510kdatabase.net/k030861/ 2003-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k030861-ha-pmi-flanged-acetabular-component-fda-510k.jpg K030861 - HA PMI FLANGED ACETABULAR COMPONENT K030861 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jun 2003. https://www.510kdatabase.net/k024192/ 2003-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k024192-vectorvision-fluoro3d-fda-510k.jpg K024192 - VECTORVISION FLUORO3D K024192 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Jun 2003. https://www.510kdatabase.net/k031495/ 2003-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k031495-pinnacle-duofix-ha-acetabular-cup-fda-510k.jpg K031495 - PINNACLE DUOFIX HA ACETABULAR CUP PROSTHESIS K031495 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jun 2003. https://www.510kdatabase.net/k031569/ 2003-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k031569-datascope-ca-40-8fr-iabs-model-0684-00-fda-510k.jpg K031569 - DATASCOPE CA 40 8FR. IABS, MODEL 0684-00-04XX K031569 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Jun 2003. https://www.510kdatabase.net/k031663/ 2003-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k031663-ge-vivid-7-model-fc0003xx-fda-510k.jpg K031663 - GE VIVID 7, MODEL FC0003XX K031663 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jun 2003. https://www.510kdatabase.net/k030738/ 2003-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k030738-siemens-multiview-infinity-telemetry-fda-510k.jpg K030738 - SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM K030738 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 2003. https://www.510kdatabase.net/k030816/ 2003-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k030816-msd-cable-reduction-system-fda-510k.jpg K030816 - MSD CABLE REDUCTION SYSTEM K030816 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Jun 2003. https://www.510kdatabase.net/k030964/ 2003-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k030964-calibration-plasma-lmw-heparin-fda-510k.jpg K030964 - CALIBRATION PLASMA LMW HEPARIN K030964 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jun 2003. https://www.510kdatabase.net/k030965/ 2003-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k030965-control-plasma-lmw-heparin-fda-510k.jpg K030965 - CONTROL PLASMA LMW HEPARIN K030965 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jun 2003. https://www.510kdatabase.net/k031004/ 2003-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k031004-syva-emit-ii-plus-amphetamines-assay-fda-510k.jpg K031004 - SYVA EMIT II PLUS AMPHETAMINES ASSAY K031004 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Dade Behring, Inc.. Cleared Jun 2003. https://www.510kdatabase.net/k031573/ 2003-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k031573-synthes-35-mm-low-profile-pelvic-fda-510k.jpg K031573 - SYNTHES 3.5 MM LOW PROFILE PELVIC RECONSTRUCTION PLATE K031573 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jun 2003. https://www.510kdatabase.net/k030710/ 2003-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k030710-bio-modular-shoulder-system-fda-510k.jpg K030710 - BIO-MODULAR SHOULDER SYSTEM K030710 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jun 2003. https://www.510kdatabase.net/k031303/ 2003-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k031303-aesculap-miethke-shunt-system-gravity-fda-510k.jpg K031303 - AESCULAP-MIETHKE SHUNT SYSTEM GRAVITY ASSISTED VALVE (GAV) K031303 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Jun 2003. https://www.510kdatabase.net/k030640/ 2003-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k030640-siemens-micro2-with-vai-software-fda-510k.jpg K030640 - SIEMENS MICRO2+ WITH VAI SOFTWARE K030640 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 2003. https://www.510kdatabase.net/k030724/ 2003-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k030724-alumina-ceramic-femoral-heads-28-and-fda-510k.jpg K030724 - ALUMINA CERAMIC FEMORAL HEADS, 28 AND 32 MM K030724 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jun 2003. https://www.510kdatabase.net/k031000/ 2003-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k031000-labsystem-iii-ep-laboratory-wwindows-fda-510k.jpg K031000 - LABSYSTEM III EP LABORATORY W/WINDOWS PLATFORM & WINDOWS EP SOFTWARE VERSION 1.0 K031000 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jun 2003. https://www.510kdatabase.net/k031135/ 2003-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k031135-glucose-flex-reagent-cartridge-gluc-fda-510k.jpg K031135 - GLUCOSE FLEX REAGENT CARTRIDGE (GLUC) K031135 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Jun 2003. https://www.510kdatabase.net/k031306/ 2003-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k031306-bd-phoenix-automated-microbiology-fda-510k.jpg K031306 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - MOXIFLOXACIN GRAM POSITIVE K031306 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Jun 2003. https://www.510kdatabase.net/k031506/ 2003-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k031506-access-immunoassay-system-toxo-igm-ii-fda-510k.jpg K031506 - ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAY K031506 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jun 2003. https://www.510kdatabase.net/k021557/ 2003-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k021557-spectrum-silicone-catheter-fda-510k.jpg K021557 - SPECTRUM SILICONE CATHETER K021557 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cook, Inc.. Cleared May 2003. https://www.510kdatabase.net/k031508/ 2003-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k031508-synthes-usa-sternal-reconstruction-fda-510k.jpg K031508 - SYNTHES (USA) STERNAL RECONSTRUCTION SYSTEM K031508 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared May 2003. https://www.510kdatabase.net/k024278/ 2003-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k024278-paceart-system-fda-510k.jpg K024278 - PACEART SYSTEM K024278 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared May 2003. https://www.510kdatabase.net/k030781/ 2003-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k030781-kodak-directview-pacsimage-management-fda-510k.jpg K030781 - KODAK DIRECTVIEW PACS/IMAGE MANAGEMENT SYSTEM, KODAK DIRECTVIEW WORKFLOW MANAGER,KODAK DIRECTVIEW CX/DX, KODAK DIRECTVIB K030781 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared May 2003. https://www.510kdatabase.net/k031286/ 2003-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k031286-safil-and-safil-quick-synthetic-fda-510k.jpg K031286 - SAFIL AND SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE K031286 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared May 2003. https://www.510kdatabase.net/k030612/ 2003-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k030612-genesis-ii-total-knee-system-fda-510k.jpg K030612 - GENESIS II TOTAL KNEE SYSTEM K030612 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared May 2003. https://www.510kdatabase.net/k030956/ 2003-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k030956-navigator-ureteral-access-sheath-set-fda-510k.jpg K030956 - NAVIGATOR URETERAL ACCESS SHEATH SET K030956 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared May 2003. https://www.510kdatabase.net/k031371/ 2003-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k031371-saphyre-bipolar-ablation-probes-fda-510k.jpg K031371 - SAPHYRE BIPOLAR ABLATION PROBES K031371 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared May 2003. https://www.510kdatabase.net/k023566/ 2003-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k023566-codman-isocool-bipolar-forceps-fda-510k.jpg K023566 - CODMAN ISOCOOL BIPOLAR FORCEPS K023566 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared May 2003. https://www.510kdatabase.net/k030623/ 2003-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k030623-smith-nephew-profix-total-knee-system-fda-510k.jpg K030623 - SMITH & NEPHEW PROFIX TOTAL KNEE SYSTEM K030623 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared May 2003. https://www.510kdatabase.net/k030845/ 2003-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k030845-coaguchek-pts-test-for-prothrombin-fda-510k.jpg K030845 - COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING K030845 is a FDA 510(k) cleared hematology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared May 2003. https://www.510kdatabase.net/k031274/ 2003-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k031274-model-5071-myocardial-pacing-lead-fda-510k.jpg K031274 - MODEL 5071 MYOCARDIAL PACING LEAD K031274 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared May 2003. https://www.510kdatabase.net/k031334/ 2003-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k031334-texas-t-plate-fda-510k.jpg K031334 - TEXAS T - PLATE K031334 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared May 2003. https://www.510kdatabase.net/k031379/ 2003-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k031379-dyonics-vision-325z-dv3-ccd-hermes-fda-510k.jpg K031379 - DYONICS VISION 325Z DV3-CCD HERMES READY CAMERA SYSTEM, MODEL 7209531 K031379 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared May 2003. https://www.510kdatabase.net/k031430/ 2003-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k031430-cemex-system-fast-fda-510k.jpg K031430 - CEMEX SYSTEM FAST K031430 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared May 2003. https://www.510kdatabase.net/k031469/ 2003-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k031469-aquilion-super-4-multislice-ct-scanner-fda-510k.jpg K031469 - AQUILION SUPER 4 MULTISLICE CT SCANNER, MODEL TSX-101A/7 K031469 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared May 2003. https://www.510kdatabase.net/k031518/ 2003-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k031518-eopa-cap-elongated-one-piece-arterial-fda-510k.jpg K031518 - EOPA CAP ELONGATED ONE-PIECE ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODELS 774XX, 775XX, 776XX, 777XX, 788XX, K031518 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared May 2003. https://www.510kdatabase.net/k030828/ 2003-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k030828-tetracxp-system-software-and-system-fda-510k.jpg K030828 - TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE) K030828 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared May 2003. https://www.510kdatabase.net/k031122/ 2003-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k031122-hemosil-factor-x-deficient-plasma-fda-510k.jpg K031122 - HEMOSIL FACTOR X DEFICIENT PLASMA K031122 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared May 2003. https://www.510kdatabase.net/k023857/ 2003-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k023857-platelia-aspergillus-eia-models-62793-fda-510k.jpg K023857 - PLATELIA ASPERGILLUS EIA, MODELS 62793 AND 62794 K023857 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bio-Rad. Cleared May 2003. https://www.510kdatabase.net/k030986/ 2003-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k030986-bd-phoenix-automated-microbiology-fda-510k.jpg K030986 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM TRIMETHOPRIM - GN 0.5-16 UG/ML K030986 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared May 2003. https://www.510kdatabase.net/k031295/ 2003-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k031295-bard-innerlace-biourethral-support-fda-510k.jpg K031295 - BARD INNERLACE BIOURETHRAL SUPPORT SYSTEM K031295 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 2003. https://www.510kdatabase.net/k031332/ 2003-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k031332-bard-pelvisoft-acellular-collagen-fda-510k.jpg K031332 - BARD PELVISOFT ACELLULAR COLLAGEN BIOMESH K031332 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 2003. https://www.510kdatabase.net/k031343/ 2003-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k031343-tpsa-flex-reagent-cartridge-fda-510k.jpg K031343 - TPSA FLEX REAGENT CARTRIDGE K031343 is a FDA 510(k) cleared immunology medical device. Manufacturer: Dade Behring, Inc.. Cleared May 2003. https://www.510kdatabase.net/k031123/ 2003-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k031123-codman-bactiseal-barium-striped-fda-510k.jpg K031123 - CODMAN BACTISEAL BARIUM STRIPED CATHETERS K031123 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared May 2003. https://www.510kdatabase.net/k022834/ 2003-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k022834-dinamap-pro-1000-monitor-with-fda-510k.jpg K022834 - DINAMAP PRO 1000 MONITOR WITH SUPERSTAT, MODEL 1000 K022834 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared May 2003. https://www.510kdatabase.net/k031396/ 2003-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k031396-advantage-workstation-pasting-11-fda-510k.jpg K031396 - ADVANTAGE WORKSTATION PASTING 1.1 K031396 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared May 2003. https://www.510kdatabase.net/k030513/ 2003-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k030513-cell-dyn-1800-system-fda-510k.jpg K030513 - CELL-DYN 1800 SYSTEM K030513 is a FDA 510(k) cleared hematology medical device. Manufacturer: Abbott Laboratories. Cleared May 2003. https://www.510kdatabase.net/k031299/ 2003-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k031299-elecsys-lh-calset-ii-fda-510k.jpg K031299 - ELECSYS LH CALSET II K031299 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared May 2003. https://www.510kdatabase.net/k031089/ 2003-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k031089-gore-flex-mp8-multipurpose-torso-array-fda-510k.jpg K031089 - GORE-FLEX MP8 MULTIPURPOSE TORSO ARRAY K031089 is a FDA 510(k) cleared radiology medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared May 2003. https://www.510kdatabase.net/k014199/ 2003-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k014199-surgical-simplex-p-with-tobramycin-fda-510k.jpg K014199 - SURGICAL SIMPLEX P WITH TOBRAMYCIN K014199 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared May 2003. https://www.510kdatabase.net/k023253/ 2003-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k023253-pediatric-central-venous-catheter-kit-fda-510k.jpg K023253 - PEDIATRIC CENTRAL VENOUS CATHETER KIT K023253 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared May 2003. https://www.510kdatabase.net/k031186/ 2003-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k031186-luminexx-endoscopic-biliary-stent-fda-510k.jpg K031186 - LUMINEXX ENDOSCOPIC BILIARY STENT K031186 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 2003. https://www.510kdatabase.net/k031261/ 2003-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k031261-card-ep-fda-510k.jpg K031261 - CARD EP K031261 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared May 2003. https://www.510kdatabase.net/k031270/ 2003-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k031270-access-cea-reagents-for-use-on-the-fda-510k.jpg K031270 - ACCESS CEA REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS K031270 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared May 2003. https://www.510kdatabase.net/k031320/ 2003-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k031320-ek-pro-arrhythmia-detection-algorithm-fda-510k.jpg K031320 - EK-PRO ARRHYTHMIA DETECTION ALGORITHM K031320 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared May 2003. https://www.510kdatabase.net/k011399/ 2003-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k011399-biomet-craniofacial-acrylic-cement-fda-510k.jpg K011399 - BIOMET CRANIOFACIAL ACRYLIC CEMENT K011399 is a FDA 510(k) cleared neurology medical device. Manufacturer: Biomet, Inc.. Cleared May 2003. https://www.510kdatabase.net/k031129/ 2003-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k031129-poly-per-q-cath-picc-catheters-fda-510k.jpg K031129 - POLY PER-Q-CATH PICC CATHETERS K031129 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 2003. https://www.510kdatabase.net/k031178/ 2003-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k031178-synthes-usa-35-mm-broad-lcp-45-mm-lcp-fda-510k.jpg K031178 - SYNTHES (USA) 3.5 MM BROAD LCP & 4.5 MM LCP DISTAL HUMERUS PLATES K031178 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared May 2003. https://www.510kdatabase.net/k031230/ 2003-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k031230-ge-propeller-imaging-option-for-mri-fda-510k.jpg K031230 - GE PROPELLER IMAGING OPTION FOR MRI K031230 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared May 2003. https://www.510kdatabase.net/k031269/ 2003-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k031269-access-thyroglobulin-reagents-on-the-fda-510k.jpg K031269 - ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS K031269 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared May 2003. https://www.510kdatabase.net/k031297/ 2003-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k031297-access-ov-monitor-assay-fda-510k.jpg K031297 - ACCESS OV MONITOR ASSAY K031297 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared May 2003. https://www.510kdatabase.net/k030733/ 2003-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k030733-mayo-conservative-hip-prosthesis-model-fda-510k.jpg K030733 - MAYO CONSERVATIVE HIP PROSTHESIS, MODEL 8026 SERIES K030733 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared May 2003. https://www.510kdatabase.net/k031162/ 2003-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k031162-smith-nephew-orthopaedic-cabling-system-fda-510k.jpg K031162 - SMITH & NEPHEW ORTHOPAEDIC CABLING SYSTEM K031162 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared May 2003. https://www.510kdatabase.net/k031185/ 2003-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k031185-abbott-plum-a-infusion-pump-with-a-fda-510k.jpg K031185 - ABBOTT PLUM A+ INFUSION PUMP WITH A HPL/RS PLUG-AND-PLAY MODULE K031185 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Apr 2003. https://www.510kdatabase.net/k031002/ 2003-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k031002-synchron-systems-opiate-reagent-fda-510k.jpg K031002 - SYNCHRON SYSTEMS OPIATE REAGENT K031002 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Apr 2003. https://www.510kdatabase.net/k030428/ 2003-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k030428-roche-online-tdm-phenytoin-fda-510k.jpg K030428 - ROCHE ONLINE TDM PHENYTOIN K030428 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Apr 2003. https://www.510kdatabase.net/k031127/ 2003-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k031127-orthopedic-wire-fda-510k.jpg K031127 - ORTHOPEDIC WIRE K031127 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Apr 2003. https://www.510kdatabase.net/k030974/ 2003-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k030974-exeltra-high-flux-dialyzer-models-150-fda-510k.jpg K030974 - EXELTRA HIGH FLUX DIALYZER, MODELS 150 & 170 K030974 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Apr 2003. https://www.510kdatabase.net/k030975/ 2003-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k030975-exeltra-plus-high-flux-dialyzer-model-fda-510k.jpg K030975 - EXELTRA PLUS HIGH FLUX DIALYZER, MODEL 210 K030975 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Apr 2003. https://www.510kdatabase.net/k030681/ 2003-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k030681-quanta-plex-ena-profile-5-fda-510k.jpg K030681 - QUANTA PLEX ENA PROFILE 5 K030681 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Apr 2003. https://www.510kdatabase.net/k030779/ 2003-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k030779-5f-medtronic-launcher-guide-catheter-fda-510k.jpg K030779 - 5F MEDTRONIC LAUNCHER GUIDE CATHETER K030779 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Apr 2003. https://www.510kdatabase.net/k030979/ 2003-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k030979-modification-to-depuy-solution-system-fda-510k.jpg K030979 - MODIFICATION TO DEPUY SOLUTION SYSTEM HIP PROSTHESIS K030979 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Apr 2003. https://www.510kdatabase.net/k031087/ 2003-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k031087-edwards-introducer-sheath-fda-510k.jpg K031087 - EDWARDS INTRODUCER SHEATH K031087 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Apr 2003. https://www.510kdatabase.net/k031090/ 2003-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k031090-modification-to-xia-stainless-steel-fda-510k.jpg K031090 - MODIFICATION TO XIA STAINLESS STEEL SYSTEM K031090 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Apr 2003. https://www.510kdatabase.net/k023256/ 2003-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k023256-precision-xtramedisense-fda-510k.jpg K023256 - PRECISION XTRA/MEDISENSE OPTIUM/PRECISION EASY/MEDISENSE OPTIUM EASY BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLO K023256 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Apr 2003. https://www.510kdatabase.net/k030310/ 2003-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k030310-synthes-stainless-steel-modular-hand-fda-510k.jpg K030310 - SYNTHES STAINLESS STEEL MODULAR HAND SYSTEM K030310 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Apr 2003. https://www.510kdatabase.net/k030556/ 2003-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k030556-steelex-electrode-set-fda-510k.jpg K030556 - STEELEX ELECTRODE SET K030556 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Aesculap, Inc.. Cleared Apr 2003. https://www.510kdatabase.net/k030606/ 2003-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k030606-coulter-lh-750-body-fluids-application-fda-510k.jpg K030606 - COULTER LH 750 BODY FLUIDS APPLICATION K030606 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Apr 2003. https://www.510kdatabase.net/k030782/ 2003-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k030782-seamguard-bioabsorbable-staple-line-fda-510k.jpg K030782 - SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL K030782 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Apr 2003. https://www.510kdatabase.net/k030735/ 2003-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k030735-modified-verte-stack-spinal-system-fda-510k.jpg K030735 - MODIFIED VERTE-STACK SPINAL SYSTEM K030735 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Apr 2003. https://www.510kdatabase.net/k030866/ 2003-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k030866-synthes-anterior-cslp-system-fda-510k.jpg K030866 - SYNTHES ANTERIOR CSLP SYSTEM K030866 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Apr 2003. https://www.510kdatabase.net/k030291/ 2003-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k030291-coulter-act-5diff-autoloader-al-fda-510k.jpg K030291 - COULTER ACT 5DIFF AUTOLOADER (AL) K030291 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Apr 2003. https://www.510kdatabase.net/k030855/ 2003-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k030855-modification-to-endovive-initial-fda-510k.jpg K030855 - MODIFICATION TO ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, PEG SAFETY KIT K030855 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Apr 2003. https://www.510kdatabase.net/k030213/ 2003-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k030213-online-dat-ii-cannabinoids-ii-fda-510k.jpg K030213 - ONLINE DAT II CANNABINOIDS II K030213 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Apr 2003. https://www.510kdatabase.net/k030555/ 2003-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k030555-gps-platelet-separation-kit-with-fda-510k.jpg K030555 - GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A K030555 is a FDA 510(k) cleared hematology medical device. Manufacturer: Biomet, Inc.. Cleared Apr 2003. https://www.510kdatabase.net/k030069/ 2003-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k030069-synthes-poly-l-lactide-co-glycolide-fda-510k.jpg K030069 - SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEM K030069 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Apr 2003. https://www.510kdatabase.net/k030982/ 2003-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k030982-syngo-colonography-software-package-fda-510k.jpg K030982 - SYNGO COLONOGRAPHY SOFTWARE PACKAGE K030982 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 2003. https://www.510kdatabase.net/k030858/ 2003-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k030858-synthes-usa-lcp-proximal-femur-plate-fda-510k.jpg K030858 - SYNTHES (USA) LCP PROXIMAL FEMUR PLATE AND SCREWS K030858 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Apr 2003. https://www.510kdatabase.net/k030318/ 2003-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k030318-p2-polyether-fda-510k.jpg K030318 - P2 POLYETHER K030318 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Apr 2003. https://www.510kdatabase.net/k030686/ 2003-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k030686-optetrak-total-knee-system-molded-fda-510k.jpg K030686 - OPTETRAK TOTAL KNEE SYSTEM - MOLDED METAL-BACK TIBIAL COMPONENT K030686 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Apr 2003. https://www.510kdatabase.net/k030736/ 2003-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k030736-verte-stack-spinal-system-extra-small-fda-510k.jpg K030736 - VERTE-STACK SPINAL SYSTEM, EXTRA SMALL SIZES K030736 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Apr 2003. https://www.510kdatabase.net/k030153/ 2003-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k030153-zca-all-poly-acetabular-cup-snap-in-fda-510k.jpg K030153 - ZCA ALL-POLY ACETABULAR CUP, SNAP-IN, MODEL 8005-946/958-32 K030153 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Apr 2003. https://www.510kdatabase.net/k030390/ 2003-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k030390-synthes-large-combination-clamp-and-fda-510k.jpg K030390 - SYNTHES LARGE COMBINATION CLAMP AND DYNAMIZATION CLIP - MR SAFE K030390 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Apr 2003. https://www.510kdatabase.net/k030677/ 2003-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k030677-bd-phoenix-automated-microbiology-fda-510k.jpg K030677 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-VANCOMYCIN GRAM POSITIVE K030677 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Apr 2003. https://www.510kdatabase.net/k030740/ 2003-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k030740-modification-to-tina-quant-d-dimer-fda-510k.jpg K030740 - MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM K030740 is a FDA 510(k) cleared hematology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Apr 2003. https://www.510kdatabase.net/k030874/ 2003-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k030874-ge-30t-signa-infinity-twinspeed-with-fda-510k.jpg K030874 - GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM K030874 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Mar 2003. https://www.510kdatabase.net/k024334/ 2003-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k024334-quanta-lite-hpylori-iga-elisa-fda-510k.jpg K024334 - QUANTA LITE H.PYLORI IGA ELISA K024334 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Mar 2003. https://www.510kdatabase.net/k030201/ 2003-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k030201-modification-to-export-aspiration-fda-510k.jpg K030201 - MODIFICATION TO EXPORT ASPIRATION CATHETER K030201 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Mar 2003. https://www.510kdatabase.net/k030789/ 2003-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k030789-amsco-century-steam-sterilizer-fda-510k.jpg K030789 - AMSCO CENTURY STEAM STERILIZER K030789 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Mar 2003. https://www.510kdatabase.net/k030601/ 2003-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k030601-verte-stack-spinal-system-fda-510k.jpg K030601 - VERTE-STACK SPINAL SYSTEM K030601 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Mar 2003. https://www.510kdatabase.net/k030645/ 2003-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k030645-boston-scientific-express-biliary-ld-fda-510k.jpg K030645 - BOSTON SCIENTIFIC EXPRESS BILIARY LD UNMOUNTED STENT K030645 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Mar 2003. https://www.510kdatabase.net/k022949/ 2003-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k022949-synthes-uss-clickx-uss-vas-dual-fda-510k.jpg K022949 - SYNTHES USS, CLICK'X, USS VAS, DUAL-OPENING USS AND SMALL STATURE USS K022949 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Mar 2003. https://www.510kdatabase.net/k024349/ 2003-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k024349-aesulap-kopitnik-avm-microclips-and-fda-510k.jpg K024349 - AESULAP KOPITNIK AVM MICROCLIPS AND APPLIER K024349 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Mar 2003. https://www.510kdatabase.net/k021033/ 2003-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k021033-stimuplex-dig-rc-nerve-stimulator-fda-510k.jpg K021033 - STIMUPLEX-DIG-RC NERVE STIMULATOR K021033 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Mar 2003. https://www.510kdatabase.net/k022198/ 2003-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k022198-endoscope-set-for-magnetic-resonance-fda-510k.jpg K022198 - ENDOSCOPE SET FOR MAGNETIC RESONANCE (MR), MODELS 8767.412, 8767.121 & 8767.452 K022198 is a FDA 510(k) cleared neurology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Mar 2003. https://www.510kdatabase.net/k030107/ 2003-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k030107-100mm-wallstent-rx-biliary-fda-510k.jpg K030107 - 100MM WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS M00569800 8MM, M00569810 10MM K030107 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Mar 2003. https://www.510kdatabase.net/k030575/ 2003-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k030575-modification-to-solar-9500-information-fda-510k.jpg K030575 - MODIFICATION TO SOLAR 9500 INFORMATION MONITOR K030575 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Mar 2003. https://www.510kdatabase.net/k030579/ 2003-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k030579-bd-phoenix-automated-microbiology-fda-510k.jpg K030579 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NALIDIXIC ACID - 2-32 UG/ML K030579 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Mar 2003. https://www.510kdatabase.net/k030615/ 2003-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k030615-infinity-explorer-fda-510k.jpg K030615 - INFINITY EXPLORER K030615 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2003. https://www.510kdatabase.net/k023189/ 2003-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k023189-vista-basic-with-fm-system-fda-510k.jpg K023189 - VISTA BASIC WITH FM SYSTEM K023189 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Mar 2003. https://www.510kdatabase.net/k023692/ 2003-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k023692-global-modular-replacement-system-fda-510k.jpg K023692 - GLOBAL MODULAR REPLACEMENT SYSTEM ADAPTER K023692 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Mar 2003. https://www.510kdatabase.net/k024291/ 2003-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k024291-arthrex-continuous-wave-iii-arthoscopy-fda-510k.jpg K024291 - ARTHREX CONTINUOUS WAVE III ARTHOSCOPY PUMP, MODEL AR-6475 K024291 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Mar 2003. https://www.510kdatabase.net/k030368/ 2003-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k030368-karl-storz-megafix-t-titanium-fda-510k.jpg K030368 - KARL STORZ MEGAFIX-T TITANIUM INTERFERENCE SCREW K030368 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Mar 2003. https://www.510kdatabase.net/k030501/ 2003-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k030501-x-series-integral-lateralized-hip-fda-510k.jpg K030501 - X-SERIES INTEGRAL LATERALIZED HIP COMPONENTS K030501 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Mar 2003. https://www.510kdatabase.net/k030597/ 2003-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k030597-synthes-35mm-titanium-lcp-proximal-fda-510k.jpg K030597 - SYNTHES 3.5MM TITANIUM LCP PROXIMAL TIBIA PLATES K030597 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Mar 2003. https://www.510kdatabase.net/k030698/ 2003-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k030698-aesculap-miethke-shunt-system-w-nph-dsv-fda-510k.jpg K030698 - AESCULAP - MIETHKE SHUNT SYSTEM W/ NPH-DSV K030698 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Mar 2003. https://www.510kdatabase.net/k030287/ 2003-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k030287-hemosil-factor-xi-deficient-plasma-fda-510k.jpg K030287 - HEMOSIL FACTOR XI DEFICIENT PLASMA K030287 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Mar 2003. https://www.510kdatabase.net/k030096/ 2003-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k030096-video-arthroscope-models-ar-3050-30-ar-fda-510k.jpg K030096 - VIDEO ARTHROSCOPE, MODELS AR-3050-30, AR-3050T-30, AR-3050-70, AR-3051-30, AR-3052-30, AR3030AN, AR-3030AS, AR3030AW K030096 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Mar 2003. https://www.510kdatabase.net/k024364/ 2003-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k024364-synthes-vertebral-spacer-ti-curved-and-fda-510k.jpg K024364 - SYNTHES VERTEBRAL SPACER TI (CURVED AND NARROW) K024364 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Mar 2003. https://www.510kdatabase.net/k030438/ 2003-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k030438-bard-aquaguide-ureteral-conduit-fda-510k.jpg K030438 - BARD AQUAGUIDE URETERAL CONDUIT K030438 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 2003. https://www.510kdatabase.net/k030503/ 2003-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k030503-modification-to-contour-polaris-fda-510k.jpg K030503 - MODIFICATION TO CONTOUR POLARIS URETERAL STENT K030503 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Mar 2003. https://www.510kdatabase.net/k030628/ 2003-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k030628-sas-rsv-control-kit-fda-510k.jpg K030628 - SAS RSV CONTROL KIT K030628 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sa Scientific, Inc.. Cleared Mar 2003. https://www.510kdatabase.net/k024275/ 2003-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k024275-auto-suture-premium-plus-ceea-fda-510k.jpg K024275 - AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER K024275 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Mar 2003. https://www.510kdatabase.net/k030409/ 2003-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k030409-smart-nitinol-stent-endoscopic-biliary-fda-510k.jpg K030409 - SMART NITINOL STENT ENDOSCOPIC BILIARY SYSTEM K030409 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Mar 2003. https://www.510kdatabase.net/k030420/ 2003-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k030420-lightspeed-50-computed-tomography-system-fda-510k.jpg K030420 - LIGHTSPEED 5.0 COMPUTED TOMOGRAPHY SYSTEM K030420 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Mar 2003. https://www.510kdatabase.net/k024178/ 2003-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k024178-viatorr-endoprosthesis-fda-510k.jpg K024178 - VIATORR ENDOPROSTHESIS K024178 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Mar 2003. https://www.510kdatabase.net/k030377/ 2003-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k030377-modification-to-synthes-cervifix-system-fda-510k.jpg K030377 - MODIFICATION TO SYNTHES CERVIFIX SYSTEM K030377 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Mar 2003. https://www.510kdatabase.net/k030446/ 2003-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k030446-repicci-locked-keel-tibial-bearing-fda-510k.jpg K030446 - REPICCI LOCKED KEEL TIBIAL BEARING K030446 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Mar 2003. https://www.510kdatabase.net/k024336/ 2003-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k024336-miig-ii-bone-graft-substitute-fda-510k.jpg K024336 - MIIG II BONE GRAFT SUBSTITUTE K024336 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Mar 2003. https://www.510kdatabase.net/k030105/ 2003-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k030105-anesthesia-monitor-fda-510k.jpg K030105 - ANESTHESIA MONITOR K030105 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Mar 2003. https://www.510kdatabase.net/k030265/ 2003-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k030265-cpt-1214-hip-prostheses-model-00-8114-fda-510k.jpg K030265 - CPT 12/14 HIP PROSTHESES, MODEL 00-8114-040/050-00 K030265 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Mar 2003. https://www.510kdatabase.net/k030344/ 2003-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k030344-modular-neer-3-humeral-stems-and-fda-510k.jpg K030344 - MODULAR NEER 3 HUMERAL STEMS AND MODULAR NEER 3 HUMERAL HEADS K030344 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Mar 2003. https://www.510kdatabase.net/k030408/ 2003-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k030408-cyto-stat-tetrachrome-cd45-fitcd4-fda-510k.jpg K030408 - CYTO-STAT TETRACHROME CD45-FIT/CD4-PE/CD3-PC5 MONOCLONAL ANTIBODY REAGENT, CYTO-STAT TETRACHROM CD45-FITC/CD56-PE/CD19-A K030408 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Mar 2003. https://www.510kdatabase.net/k024340/ 2003-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k024340-smith-nephew-femoral-heads-fda-510k.jpg K024340 - SMITH & NEPHEW FEMORAL HEADS K024340 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Feb 2003. https://www.510kdatabase.net/k030178/ 2003-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k030178-calcigen-psi-bone-graft-substitute-fda-510k.jpg K030178 - CALCIGEN PSI BONE GRAFT SUBSTITUTE K030178 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Feb 2003. https://www.510kdatabase.net/k030327/ 2003-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k030327-zephir-anterior-cervical-system-fda-510k.jpg K030327 - ZEPHIR ANTERIOR CERVICAL SYSTEM K030327 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Feb 2003. https://www.510kdatabase.net/k030431/ 2003-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k030431-modification-to-dash-30004000-patient-fda-510k.jpg K030431 - MODIFICATION TO DASH 3000/4000 PATIENT MONITOR K030431 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Feb 2003. https://www.510kdatabase.net/k010555/ 2003-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k010555-jax-fda-510k.jpg K010555 - JAX K010555 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Feb 2003. https://www.510kdatabase.net/k030301/ 2003-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k030301-unicondylar-femoral-component-fda-510k.jpg K030301 - UNICONDYLAR FEMORAL COMPONENT K030301 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Feb 2003. https://www.510kdatabase.net/k024210/ 2003-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k024210-immage-systems-total-immunoglobulin-e-fda-510k.jpg K024210 - IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR K024210 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Feb 2003. https://www.510kdatabase.net/k030182/ 2003-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k030182-liquichek-d-dimer-control-model-356-357-fda-510k.jpg K030182 - LIQUICHEK D-DIMER CONTROL, MODEL 356, 357 K030182 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bio-Rad. Cleared Feb 2003. https://www.510kdatabase.net/k030215/ 2003-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k030215-biorapid-mononucleosis-fda-510k.jpg K030215 - BIORAPID MONONUCLEOSIS K030215 is a FDA 510(k) cleared immunology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Feb 2003. https://www.510kdatabase.net/k023664/ 2003-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k023664-syntra-dialyzer-model-200-fda-510k.jpg K023664 - SYNTRA + DIALYZER, MODEL 200 K023664 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Feb 2003. https://www.510kdatabase.net/k024052/ 2003-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k024052-merit-medical-1-ml-syringe-fda-510k.jpg K024052 - MERIT MEDICAL 1-ML SYRINGE K024052 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Feb 2003. https://www.510kdatabase.net/k024249/ 2003-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k024249-terumo-surguard-safety-syringe-fda-510k.jpg K024249 - TERUMO SURGUARD SAFETY SYRINGE K024249 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terumo Medical Corp.. Cleared Feb 2003. https://www.510kdatabase.net/k030045/ 2003-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k030045-olympus-cholinesterase-reagent-catalog-fda-510k.jpg K030045 - OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114) K030045 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus America, Inc.. Cleared Feb 2003. https://www.510kdatabase.net/k024008/ 2003-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k024008-small-bard-ventralex-patch-fda-510k.jpg K024008 - SMALL BARD VENTRALEX PATCH K024008 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Feb 2003. https://www.510kdatabase.net/k030193/ 2003-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k030193-advance-less-conforming-tibial-component-fda-510k.jpg K030193 - ADVANCE LESS CONFORMING TIBIAL COMPONENT K030193 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Feb 2003. https://www.510kdatabase.net/k030196/ 2003-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k030196-dyonics-power-control-unit-fda-510k.jpg K030196 - DYONICS POWER CONTROL UNIT K030196 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Feb 2003. https://www.510kdatabase.net/k030236/ 2003-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k030236-acumatch-p-series-porous-press-fit-fda-510k.jpg K030236 - ACUMATCH P-SERIES POROUS PRESS-FIT FEMORAL COMPONENT K030236 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Feb 2003. https://www.510kdatabase.net/k024162/ 2003-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k024162-spife-3000-titan-gel-igg-ief-kit-model-fda-510k.jpg K024162 - SPIFE 3000 TITAN GEL IGG IEF KIT, MODEL 3389 K024162 is a FDA 510(k) cleared immunology medical device. Manufacturer: Helena Laboratories. Cleared Feb 2003. https://www.510kdatabase.net/k023761/ 2003-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k023761-plateletworks-models-pw-a-pw-c-fda-510k.jpg K023761 - PLATELETWORKS, MODELS PW-A, PW-C K023761 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Feb 2003. https://www.510kdatabase.net/k023012/ 2003-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k023012-smartset-hv-bone-cement-fda-510k.jpg K023012 - SMARTSET HV BONE CEMENT K023012 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Feb 2003. https://www.510kdatabase.net/k024038/ 2003-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k024038-n-latex-iga-fda-510k.jpg K024038 - N LATEX IGA K024038 is a FDA 510(k) cleared immunology medical device. Manufacturer: Dade Behring, Inc.. Cleared Feb 2003. https://www.510kdatabase.net/k024082/ 2003-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k024082-hemosil-factor-vii-deficient-plasma-fda-510k.jpg K024082 - HEMOSIL FACTOR VII DEFICIENT PLASMA K024082 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Feb 2003. https://www.510kdatabase.net/k024147/ 2003-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k024147-paxscan-4030-medical-digital-imaging-fda-510k.jpg K024147 - PAXSCAN 4030 MEDICAL DIGITAL IMAGING SYSTEM K024147 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Feb 2003. https://www.510kdatabase.net/k030199/ 2003-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k030199-ge-mobile-discovery-st-pet-ct-imaging-fda-510k.jpg K030199 - GE MOBILE DISCOVERY ST PET CT IMAGING SYSTEM K030199 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Feb 2003. https://www.510kdatabase.net/k030313/ 2003-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k030313-siemens-infinity-sc-6002xl-modifications-fda-510k.jpg K030313 - SIEMENS INFINITY SC 6002XL MODIFICATIONS K030313 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 2003. https://www.510kdatabase.net/k023785/ 2003-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k023785-lung-nodule-assessment-and-comparison-fda-510k.jpg K023785 - LUNG NODULE ASSESSMENT AND COMPARISON OPTION K023785 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Feb 2003. https://www.510kdatabase.net/k024153/ 2003-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k024153-bd-phoenix-automated-microbiology-fda-510k.jpg K024153 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TETRACYCLINE - 0.5-16 UG/ML K024153 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Feb 2003. https://www.510kdatabase.net/k030255/ 2003-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k030255-silicone-dual-lumen-radpicc-catheters-fda-510k.jpg K030255 - SILICONE DUAL LUMEN RADPICC CATHETERS K030255 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Feb 2003. https://www.510kdatabase.net/k030124/ 2003-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k030124-olympus-ferritin-reagent-fda-510k.jpg K030124 - OLYMPUS FERRITIN REAGENT K030124 is a FDA 510(k) cleared immunology medical device. Manufacturer: Olympus America, Inc.. Cleared Feb 2003. https://www.510kdatabase.net/k023879/ 2003-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k023879-small-titanium-wrist-fusion-plate-fda-510k.jpg K023879 - SMALL TITANIUM WRIST FUSION PLATE K023879 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Feb 2003. https://www.510kdatabase.net/k023921/ 2003-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k023921-jet-x-ha-coated-half-pins-fda-510k.jpg K023921 - JET-X HA COATED HALF PINS K023921 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Feb 2003. https://www.510kdatabase.net/k030079/ 2003-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k030079-versys-beaded-fullcoat-bowed-revision-fda-510k.jpg K030079 - VERSYS BEADED FULLCOAT BOWED REVISION HIP PROSTHESIS K030079 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Feb 2003. https://www.510kdatabase.net/k030122/ 2003-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k030122-depuy-summit-basic-press-fit-hip-stem-fda-510k.jpg K030122 - DEPUY SUMMIT BASIC PRESS-FIT HIP STEM K030122 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Feb 2003. https://www.510kdatabase.net/k023988/ 2003-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k023988-ge-discovery-ls-system-fda-510k.jpg K023988 - GE DISCOVERY LS SYSTEM K023988 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Feb 2003. https://www.510kdatabase.net/k024066/ 2003-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k024066-infinion-software-features-fda-510k.jpg K024066 - INFINION SOFTWARE FEATURES K024066 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Feb 2003. https://www.510kdatabase.net/k023724/ 2003-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k023724-duracon-cs-lipped-extra-small-tibial-fda-510k.jpg K023724 - DURACON CS LIPPED EXTRA SMALL TIBIAL INSERT K023724 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Feb 2003. https://www.510kdatabase.net/k024152/ 2003-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k024152-bd-phoenix-automated-microbiology-fda-510k.jpg K024152 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - RIFAMPIN 0.25-32 UG/ML K024152 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Jan 2003. https://www.510kdatabase.net/k023704/ 2003-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k023704-ksea-scb-acc-control-fda-510k.jpg K023704 - KSEA SCB ACC CONTROL K023704 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jan 2003. https://www.510kdatabase.net/k022845/ 2003-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k022845-sas-rsv-test-fda-510k.jpg K022845 - SAS RSV TEST K022845 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Jan 2003. https://www.510kdatabase.net/k023659/ 2003-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k023659-1-ccd-endocam-5520-system-fda-510k.jpg K023659 - 1-CCD ENDOCAM 5520 SYSTEM K023659 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Jan 2003. https://www.510kdatabase.net/k023764/ 2003-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k023764-unicel-dxi-800-access-immunoassay-fda-510k.jpg K023764 - UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100 K023764 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jan 2003. https://www.510kdatabase.net/k023802/ 2003-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k023802-synthes-45-mm-titanium-lcp-proximal-fda-510k.jpg K023802 - SYNTHES 4.5 MM TITANIUM LCP PROXIMAL TIBIA PLATING SYSTEM K023802 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jan 2003. https://www.510kdatabase.net/k023901/ 2003-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k023901-alumina-v40-femoral-heads-fda-510k.jpg K023901 - ALUMINA V40 FEMORAL HEADS K023901 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jan 2003. https://www.510kdatabase.net/k030083/ 2003-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k030083-vaxcel-with-pasv-port-fda-510k.jpg K030083 - VAXCEL WITH PASV PORT K030083 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Boston Scientific Corp. Cleared Jan 2003. https://www.510kdatabase.net/k030002/ 2003-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k030002-lifeshield-primary-iv-set-conv-pin-clave-fda-510k.jpg K030002 - LIFESHIELD PRIMARY IV SET CONV. PIN. CLAVE K030002 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Jan 2003. https://www.510kdatabase.net/k023568/ 2003-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k023568-bd-phoenix-automated-microbiology-system-fda-510k.jpg K023568 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM K023568 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Jan 2003. https://www.510kdatabase.net/k023878/ 2003-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k023878-guardwire-temporary-occlusion-and-fda-510k.jpg K023878 - GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM K023878 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jan 2003. https://www.510kdatabase.net/k030090/ 2003-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k030090-h2-heated-humidifier-fda-510k.jpg K030090 - H2 HEATED HUMIDIFIER K030090 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Jan 2003. https://www.510kdatabase.net/k022447/ 2003-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k022447-bard-er-ureteral-stent-with-suture-fda-510k.jpg K022447 - BARD ER URETERAL STENT WITH SUTURE K022447 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 2003. https://www.510kdatabase.net/k023743/ 2003-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k023743-smith-nephew-global-bipolar-system-fda-510k.jpg K023743 - SMITH & NEPHEW GLOBAL BIPOLAR SYSTEM K023743 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jan 2003. https://www.510kdatabase.net/k023776/ 2003-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k023776-xeno-iii-dental-adhesive-fda-510k.jpg K023776 - XENO III DENTAL ADHESIVE K023776 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jan 2003. https://www.510kdatabase.net/k023941/ 2003-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k023941-synthes-tomofix-osteotomy-system-fda-510k.jpg K023941 - SYNTHES TOMOFIX OSTEOTOMY SYSTEM K023941 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jan 2003. https://www.510kdatabase.net/k024022/ 2003-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k024022-osteo-cable-sleeve-fda-510k.jpg K024022 - OSTEO-CABLE SLEEVE K024022 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jan 2003. https://www.510kdatabase.net/k030047/ 2003-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k030047-freedom-constrained-liners-fda-510k.jpg K030047 - FREEDOM CONSTRAINED LINERS K030047 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jan 2003. https://www.510kdatabase.net/k023546/ 2003-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k023546-maxim-accel-knee-system-fda-510k.jpg K023546 - MAXIM ACCEL KNEE SYSTEM K023546 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jan 2003. https://www.510kdatabase.net/k023813/ 2003-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k023813-bipolar-forceps-fda-510k.jpg K023813 - BIPOLAR FORCEPS K023813 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Jan 2003. https://www.510kdatabase.net/k024218/ 2003-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k024218-liquichek-anti-ss-a-control-positive-fda-510k.jpg K024218 - LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114 K024218 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Jan 2003. https://www.510kdatabase.net/k024220/ 2003-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k024220-liquichek-autoimmune-negative-control-fda-510k.jpg K024220 - LIQUICHEK AUTOIMMUNE NEGATIVE CONTROL, CATALOG #130 K024220 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Jan 2003. https://www.510kdatabase.net/k024232/ 2003-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k024232-liquichek-anti-ss-b-control-positive-fda-510k.jpg K024232 - LIQUICHEK ANTI-SS-B CONTROL, POSITIVE, CATALOG #113 K024232 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Jan 2003. https://www.510kdatabase.net/k030012/ 2003-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k030012-ck-mb-and-ck-mb-calibrators-on-the-fda-510k.jpg K030012 - CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND 386372 K030012 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jan 2003. https://www.510kdatabase.net/k022976/ 2003-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k022976-stratus-cs-d-dimer-ddmr-method-testpak-fda-510k.jpg K022976 - STRATUS CS D-DIMER (DDMR) METHOD (TESTPAK & DILPAK), MODELS CDDMR & CDDMR-D K022976 is a FDA 510(k) cleared hematology medical device. Manufacturer: Dade Behring, Inc.. Cleared Jan 2003. https://www.510kdatabase.net/k023141/ 2003-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k023141-modification-to-standard-human-plasma-fda-510k.jpg K023141 - MODIFICATION TO STANDARD HUMAN PLASMA K023141 is a FDA 510(k) cleared hematology medical device. Manufacturer: Dade Behring, Inc.. Cleared Jan 2003. https://www.510kdatabase.net/k024067/ 2003-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k024067-rheumatoid-factor-rf-fda-510k.jpg K024067 - RHEUMATOID FACTOR (RF) K024067 is a FDA 510(k) cleared immunology medical device. Manufacturer: Abbott Laboratories. Cleared Jan 2003. https://www.510kdatabase.net/k024217/ 2003-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k024217-liquichek-ana-control-speckled-pattern-fda-510k.jpg K024217 - LIQUICHEK ANA CONTROL, SPECKLED PATTERN, POSITIVE, CATALOG #108 K024217 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Jan 2003. https://www.510kdatabase.net/k024219/ 2003-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k024219-liquichek-anti-sm-control-positive-fda-510k.jpg K024219 - LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115 K024219 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Jan 2003. https://www.510kdatabase.net/k024221/ 2003-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k024221-liquichek-ana-control-homogeneous-fda-510k.jpg K024221 - LIQUICHEK ANA CONTROL HOMOGENEOUS PATTERN CONTROL, POSOTIVE, CATALOG #118 K024221 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Jan 2003. https://www.510kdatabase.net/k024222/ 2003-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k024222-liquichek-ana-control-centromere-fda-510k.jpg K024222 - LIQUICHEK ANA CONTROL CENTROMERE PATTERN, POSITIVE, CATALOG #112 K024222 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Jan 2003. https://www.510kdatabase.net/k024224/ 2003-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k024224-liquichek-anti-smooth-muscle-control-fda-510k.jpg K024224 - LIQUICHEK ANTI-SMOOTH MUSCLE CONTROL, POSITIVE, CATALOG #129 K024224 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Jan 2003. https://www.510kdatabase.net/k024225/ 2003-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k024225-liquichek-anti-ndna-control-positive-fda-510k.jpg K024225 - LIQUICHEK ANTI-NDNA CONTROL, POSITIVE, CATALOG #119 K024225 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Jan 2003. https://www.510kdatabase.net/k024227/ 2003-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k024227-liquichek-anti-mitochondrial-control-fda-510k.jpg K024227 - LIQUICHEK ANTI-MITOCHONDRIAL CONTROL, POSITIVE, CATALOG #127 K024227 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Jan 2003. https://www.510kdatabase.net/k024229/ 2003-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k024229-liquichek-ana-control-nucleolar-fda-510k.jpg K024229 - LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, POSITIVE, CATALOG #111 K024229 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Jan 2003. https://www.510kdatabase.net/k024230/ 2003-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k024230-liquichek-ana-control-set-positive-fda-510k.jpg K024230 - LIQUICHEK ANA CONTROL SET, POSITIVE: HOMOGENEOUS, SPECKLED, CENTROMERE AND NUCLEOLAR PATTERNS, CATALOG #131 K024230 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Jan 2003. https://www.510kdatabase.net/k021992/ 2003-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k021992-dhs-disposable-hood-system-fda-510k.jpg K021992 - DHS DISPOSABLE HOOD SYSTEM K021992 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Biomet, Inc.. Cleared Jan 2003. https://www.510kdatabase.net/k023839/ 2003-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k023839-hemosil-factor-v-deficient-plasma-fda-510k.jpg K023839 - HEMOSIL FACTOR V DEFICIENT PLASMA K023839 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jan 2003. https://www.510kdatabase.net/k024126/ 2003-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k024126-clear-or-braided-contrast-media-fda-510k.jpg K024126 - CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE OR WITHOUT ROTATOR, CATH LAB KIT K024126 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Laboratories. Cleared Jan 2003. https://www.510kdatabase.net/k024223/ 2003-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k024223-liquichek-anti-rnp-control-positive-fda-510k.jpg K024223 - LIQUICHEK ANTI-RNP CONTROL, POSITIVE, CATALOG #116 K024223 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Jan 2003. https://www.510kdatabase.net/k024231/ 2003-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k024231-liquichek-anti-mitotic-spindle-pattern-fda-510k.jpg K024231 - LIQUICHEK ANTI-MITOTIC SPINDLE PATTERN CONTROL, POSITIVE, CATALOG #118 K024231 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Jan 2003. https://www.510kdatabase.net/k024239/ 2003-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k024239-chemo-dispensing-pin-model-12495-fda-510k.jpg K024239 - CHEMO DISPENSING PIN, MODEL 12495 K024239 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Jan 2003. https://www.510kdatabase.net/k024226/ 2003-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k024226-liquichek-anti-scl-70-control-positive-fda-510k.jpg K024226 - LIQUICHEK ANTI-SCL-70 CONTROL, POSITIVE, CATALOG #116 K024226 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Jan 2003. https://www.510kdatabase.net/k024112/ 2003-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k024112-bd-insulin-syringe-fda-510k.jpg K024112 - BD INSULIN SYRINGE K024112 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson & CO. Cleared Jan 2003. https://www.510kdatabase.net/k023895/ 2003-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k023895-bd-phoenix-automated-microbiology-fda-510k.jpg K023895 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CIPROFLOXACIN GN K023895 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Jan 2003. https://www.510kdatabase.net/k024069/ 2003-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k024069-one-piece-pediatric-arterial-cannula-fda-510k.jpg K024069 - ONE PIECE PEDIATRIC ARTERIAL CANNULA, MODEL: 77006, 77106 K024069 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jan 2003. https://www.510kdatabase.net/k022844/ 2003-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k022844-synthes-resorbable-contourable-mesh-fda-510k.jpg K022844 - SYNTHES RESORBABLE CONTOURABLE MESH K022844 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Jan 2003. https://www.510kdatabase.net/k023135/ 2003-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k023135-image3-se-disposable-full-face-mask-fda-510k.jpg K023135 - IMAGE3 SE DISPOSABLE FULL FACE MASK K023135 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Jan 2003. https://www.510kdatabase.net/k021994/ 2003-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k021994-bard-conformexx-biliary-stent-and-fda-510k.jpg K021994 - BARD CONFORMEXX BILIARY STENT AND DELIVERY SYSTEM K021994 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 2003. https://www.510kdatabase.net/k024084/ 2002-12-31 monthly 0.5 https://www.510kdatabase.net/og-image/k024084-abbott-plum-a-infusion-pump-model-12391-fda-510k.jpg K024084 - ABBOTT PLUM A+ INFUSION PUMP, MODEL 12391 K024084 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Dec 2002. https://www.510kdatabase.net/k024032/ 2002-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k024032-attain-6216a-mp-multi-purpose-guide-fda-510k.jpg K024032 - ATTAIN 6216A-MP MULTI-PURPOSE GUIDE CATHETER FOR LEFT-HEART DELIVERY K024032 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Dec 2002. https://www.510kdatabase.net/k024035/ 2002-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k024035-attain-6218a-am-amplatz-guide-catheter-fda-510k.jpg K024035 - ATTAIN 6218A-AM AMPLATZ GUIDE CATHETER FOR LEFT-HEART DELIVERY K024035 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Dec 2002. https://www.510kdatabase.net/k024037/ 2002-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k024037-narrow-ascent-interlok-femoral-fda-510k.jpg K024037 - NARROW ASCENT INTERLOK FEMORAL COMPONENTS K024037 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Dec 2002. https://www.510kdatabase.net/k024109/ 2002-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k024109-bd-ultra-fine-iii-pen-needle-fda-510k.jpg K024109 - BD ULTRA-FINE III PEN NEEDLE K024109 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson & CO. Cleared Dec 2002. https://www.510kdatabase.net/k023807/ 2002-12-26 monthly 0.5 https://www.510kdatabase.net/og-image/k023807-modification-to-alkp-fda-510k.jpg K023807 - MODIFICATION TO ALKP K023807 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Dec 2002. https://www.510kdatabase.net/k023634/ 2002-12-24 monthly 0.5 https://www.510kdatabase.net/og-image/k023634-bd-phoenix-automated-microbiology-fda-510k.jpg K023634 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-GENTAMICIN GN (0.25-16UG/ML) K023634 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Dec 2002. https://www.510kdatabase.net/k023269/ 2002-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k023269-hemosil-c-reactive-protein-high-fda-510k.jpg K023269 - HEMOSIL C-REACTIVE PROTEIN - HIGH SENSITIVITY AND HIGH SENSITIVITY CONTROLS K023269 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Dec 2002. https://www.510kdatabase.net/k023527/ 2002-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k023527-bd-phoenix-automated-microbiology-fda-510k.jpg K023527 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN - 0.25-16 UG/ML K023527 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Dec 2002. https://www.510kdatabase.net/k021826/ 2002-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k021826-trilogy-acetabular-system-constrained-fda-510k.jpg K021826 - TRILOGY ACETABULAR SYSTEM CONSTRAINED LINER, MODEL 6154 SERIES K021826 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Dec 2002. https://www.510kdatabase.net/k023480/ 2002-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k023480-access-total-bhcg-fda-510k.jpg K023480 - ACCESS TOTAL BHCG K023480 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Dec 2002. https://www.510kdatabase.net/k023858/ 2002-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k023858-bd-phoenix-automated-microbiology-system-fda-510k.jpg K023858 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM K023858 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Dec 2002. https://www.510kdatabase.net/k024060/ 2002-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k024060-modification-to-asnis-iii-cannulated-fda-510k.jpg K024060 - MODIFICATION TO ASNIS III CANNULATED SCREW SYSTEM K024060 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Dec 2002. https://www.510kdatabase.net/k014215/ 2002-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k014215-viabil-biliary-endoprosthesis-fda-510k.jpg K014215 - VIABIL BILIARY ENDOPROSTHESIS K014215 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Dec 2002. https://www.510kdatabase.net/k021803/ 2002-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k021803-reflection-constrained-liner-fda-510k.jpg K021803 - REFLECTION CONSTRAINED LINER K021803 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Dec 2002. https://www.510kdatabase.net/k022715/ 2002-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k022715-coated-vicryl-plus-antimicrobial-fda-510k.jpg K022715 - COATED VICRYL PLUS ANTIMICROBIAL (POLYGLACTIN 910) SUTURE K022715 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Dec 2002. https://www.510kdatabase.net/k023411/ 2002-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k023411-steelex-sternum-set-fda-510k.jpg K023411 - STEELEX STERNUM SET K023411 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Dec 2002. https://www.510kdatabase.net/k023862/ 2002-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k023862-norian-xr-calcium-phosphate-bone-void-fda-510k.jpg K023862 - NORIAN XR CALCIUM PHOSPHATE BONE VOID FILLER K023862 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Dec 2002. https://www.510kdatabase.net/k024098/ 2002-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k024098-cobas-integra-creatinine-plus-ver2-assay-fda-510k.jpg K024098 - COBAS INTEGRA CREATININE PLUS VER.2 ASSAY K024098 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Dec 2002. https://www.510kdatabase.net/k023115/ 2002-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k023115-ace-versanail-fda-510k.jpg K023115 - ACE VERSANAIL K023115 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Dec 2002. https://www.510kdatabase.net/k023119/ 2002-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k023119-bi-cortical-bio-post-and-washer-model-fda-510k.jpg K023119 - BI-CORTICAL BIO POST AND WASHER, MODEL AR-1367B K023119 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Dec 2002. https://www.510kdatabase.net/k023271/ 2002-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k023271-terumo-syringe-withwithout-needle-fda-510k.jpg K023271 - TERUMO SYRINGE WITH/WITHOUT NEEDLE K023271 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terumo Medical Corp.. Cleared Dec 2002. https://www.510kdatabase.net/k023374/ 2002-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k023374-groshong-nxt-dual-lumen-picc-catheters-fda-510k.jpg K023374 - GROSHONG NXT DUAL LUMEN PICC CATHETERS K023374 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 2002. https://www.510kdatabase.net/k023907/ 2002-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k023907-cordis-maxi-ld-large-diameter-balloon-fda-510k.jpg K023907 - CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA BALLOON DILATION CATHETER K023907 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Dec 2002. https://www.510kdatabase.net/k024108/ 2002-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k024108-siemens-multi-view-infinity-telemetry-fda-510k.jpg K024108 - SIEMENS MULTI VIEW INFINITY TELEMETRY SYSTEM K024108 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Dec 2002. https://www.510kdatabase.net/k023152/ 2002-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k023152-immulite-2000-allergen-specific-ige-fda-510k.jpg K023152 - IMMULITE 2000 ALLERGEN-SPECIFIC IGE K023152 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Dec 2002. https://www.510kdatabase.net/k023986/ 2002-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k023986-arthrex-opes-electrodes-and-accessories-fda-510k.jpg K023986 - ARTHREX OPES ELECTRODES AND ACCESSORIES K023986 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Arthrex, Inc.. Cleared Dec 2002. https://www.510kdatabase.net/k022683/ 2002-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k022683-sas-bloodserumurineurine-hcg-fda-510k.jpg K022683 - SAS BLOOD/SERUM/URINE/URINE HCG K022683 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sa Scientific, Inc.. Cleared Dec 2002. https://www.510kdatabase.net/k023087/ 2002-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k023087-global-modular-replacement-system-gmrs-fda-510k.jpg K023087 - GLOBAL MODULAR REPLACEMENT SYSTEM (GMRS) K023087 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Dec 2002. https://www.510kdatabase.net/k023361/ 2002-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k023361-microscan-synergies-plus-gram-negative-fda-510k.jpg K023361 - MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH GATIFLOXACIN (0.004-16 UG/ML) K023361 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Dec 2002. https://www.510kdatabase.net/k023397/ 2002-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k023397-abbott-architect-folate-fda-510k.jpg K023397 - ABBOTT ARCHITECT FOLATE K023397 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Dec 2002. https://www.510kdatabase.net/k023415/ 2002-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k023415-modification-to-dynalok-classic-spinal-fda-510k.jpg K023415 - MODIFICATION TO DYNALOK CLASSIC SPINAL SYSTEM K023415 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Dec 2002. https://www.510kdatabase.net/k023541/ 2002-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k023541-microscan-synergies-plus-gram-negative-fda-510k.jpg K023541 - MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MOXIFLOXACIN (0.004-16UG/ML) K023541 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Dec 2002. https://www.510kdatabase.net/k023788/ 2002-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k023788-columbus-cr-total-knee-system-fda-510k.jpg K023788 - COLUMBUS (CR) TOTAL KNEE SYSTEM K023788 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aesculap, Inc.. Cleared Dec 2002. https://www.510kdatabase.net/k023797/ 2002-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k023797-laurain-dewald-anterior-fixation-system-fda-510k.jpg K023797 - LAURAIN DEWALD ANTERIOR FIXATION SYSTEM K023797 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Dec 2002. https://www.510kdatabase.net/k013562/ 2002-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k013562-aurora-system-1000-series-home-self-fda-510k.jpg K013562 - AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM K013562 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Dec 2002. https://www.510kdatabase.net/k014277/ 2002-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k014277-ksea-deployable-cardiovascular-clamp-fda-510k.jpg K014277 - KSEA DEPLOYABLE CARDIOVASCULAR CLAMP K014277 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Dec 2002. https://www.510kdatabase.net/k023267/ 2002-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k023267-t2-supracondylar-nail-system-fda-510k.jpg K023267 - T2 SUPRACONDYLAR NAIL SYSTEM K023267 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Dec 2002. https://www.510kdatabase.net/k023597/ 2002-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k023597-access-ov-monitor-immunoenzymetric-assay-fda-510k.jpg K023597 - ACCESS OV MONITOR IMMUNOENZYMETRIC ASSAY K023597 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Dec 2002. https://www.510kdatabase.net/k023880/ 2002-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k023880-cardio-vations-steerable-coronary-fda-510k.jpg K023880 - CARDIO VATIONS STEERABLE CORONARY SINUS CATHETER K023880 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ethicon, Inc.. Cleared Dec 2002. https://www.510kdatabase.net/k014296/ 2002-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k014296-cd-horizon-spinal-system-fda-510k.jpg K014296 - CD HORIZON SPINAL SYSTEM K014296 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Dec 2002. https://www.510kdatabase.net/k022133/ 2002-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k022133-bd-directigen-ez-rsv-kit-fda-510k.jpg K022133 - BD DIRECTIGEN EZ RSV KIT K022133 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Dec 2002. https://www.510kdatabase.net/k023786/ 2002-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k023786-depuy-pinnacle-metal-on-metal-fda-510k.jpg K023786 - DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINER K023786 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Dec 2002. https://www.510kdatabase.net/k023811/ 2002-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k023811-modification-to-viabahn-endoprosthesis-fda-510k.jpg K023811 - MODIFICATION TO VIABAHN ENDOPROSTHESIS K023811 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Dec 2002. https://www.510kdatabase.net/k021798/ 2002-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k021798-smith-nephew-image-guided-surgical-fda-510k.jpg K021798 - SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR HIP APPLICATIONS K021798 is a FDA 510(k) cleared neurology medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Dec 2002. https://www.510kdatabase.net/k023304/ 2002-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k023304-immuliteimmulite-1000-calcitonin-model-fda-510k.jpg K023304 - IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL K023304 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Dec 2002. https://www.510kdatabase.net/k023369/ 2002-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k023369-access-total-t4-assay-fda-510k.jpg K023369 - ACCESS TOTAL T4 ASSAY K023369 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Dec 2002. https://www.510kdatabase.net/k023219/ 2002-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k023219-becton-dickinson-diabetes-software-fda-510k.jpg K023219 - BECTON DICKINSON DIABETES SOFTWARE K023219 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Becton, Dickinson & CO. Cleared Dec 2002. https://www.510kdatabase.net/k023281/ 2002-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k023281-online-dat-ii-cocaine-ii-fda-510k.jpg K023281 - ONLINE DAT II COCAINE II K023281 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Dec 2002. https://www.510kdatabase.net/k021489/ 2002-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k021489-repiphysis-limb-salvage-system-fda-510k.jpg K021489 - REPIPHYSIS LIMB SALVAGE SYSTEM K021489 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Dec 2002. https://www.510kdatabase.net/k022952/ 2002-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k022952-modular-head-bone-screw-fda-510k.jpg K022952 - MODULAR HEAD BONE SCREW K022952 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Dec 2002. https://www.510kdatabase.net/k020883/ 2002-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k020883-elecsys-probnp-calcheck-fda-510k.jpg K020883 - ELECSYS PROBNP CALCHECK K020883 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Nov 2002. https://www.510kdatabase.net/k022236/ 2002-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k022236-recovery-filter-system-model-rf-048f-fda-510k.jpg K022236 - RECOVERY FILTER SYSTEM, MODEL RF-048F K022236 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 2002. https://www.510kdatabase.net/k022977/ 2002-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k022977-stratus-cs-d-dimer-calpak-calibrator-fda-510k.jpg K022977 - STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-C K022977 is a FDA 510(k) cleared hematology medical device. Manufacturer: Dade Behring, Inc.. Cleared Nov 2002. https://www.510kdatabase.net/k023675/ 2002-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k023675-synthes-cervifix-axon-fda-510k.jpg K023675 - SYNTHES CERVIFIX/ AXON K023675 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Nov 2002. https://www.510kdatabase.net/k023681/ 2002-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k023681-renegade-stc-18-microcatheter-fda-510k.jpg K023681 - RENEGADE STC 18 MICROCATHETER K023681 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Nov 2002. https://www.510kdatabase.net/k022853/ 2002-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k022853-endotack-fda-510k.jpg K022853 - ENDOTACK K022853 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Nov 2002. https://www.510kdatabase.net/k023093/ 2002-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k023093-access-hypersensitive-htsh-assay-fda-510k.jpg K023093 - ACCESS HYPERSENSITIVE HTSH ASSAY K023093 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Nov 2002. https://www.510kdatabase.net/k023296/ 2002-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k023296-cobas-integra-online-dat-ii-cocaine-ii-fda-510k.jpg K023296 - COBAS INTEGRA ONLINE DAT II COCAINE II K023296 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Nov 2002. https://www.510kdatabase.net/k023331/ 2002-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k023331-bd-vacutainer-sst-ii-plus-tubes-fda-510k.jpg K023331 - BD VACUTAINER SST II PLUS TUBES K023331 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Becton, Dickinson & CO. Cleared Nov 2002. https://www.510kdatabase.net/k023760/ 2002-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k023760-ct-cardiac-function-analysis-software-fda-510k.jpg K023760 - CT CARDIAC FUNCTION ANALYSIS SOFTWARE, MODELS CSCF-001A AND CSCF-001B K023760 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Nov 2002. https://www.510kdatabase.net/k022799/ 2002-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k022799-trident-screw-hole-plug-and-trident-fda-510k.jpg K022799 - TRIDENT SCREW HOLE PLUG AND TRIDENT BONE SPIKE K022799 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Nov 2002. https://www.510kdatabase.net/k023720/ 2002-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k023720-sonoline-antares-ultrasound-system-fda-510k.jpg K023720 - SONOLINE ANTARES ULTRASOUND SYSTEM K023720 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2002. https://www.510kdatabase.net/k020804/ 2002-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k020804-auto-suture-premium-plus-ceea-fda-510k.jpg K020804 - AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER K020804 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Nov 2002. https://www.510kdatabase.net/k022516/ 2002-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k022516-elecsys-probnp-immunoassay-fda-510k.jpg K022516 - ELECSYS PROBNP IMMUNOASSAY K022516 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Nov 2002. https://www.510kdatabase.net/k023570/ 2002-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k023570-modification-to-verte-stack-spinal-fda-510k.jpg K023570 - MODIFICATION TO VERTE-STACK SPINAL SYSTEM K023570 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Nov 2002. https://www.510kdatabase.net/k023680/ 2002-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k023680-biobuck-cement-restrictor-fda-510k.jpg K023680 - BIOBUCK CEMENT RESTRICTOR K023680 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Nov 2002. https://www.510kdatabase.net/k021615/ 2002-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k021615-baxter-accura-system-model-5m5660-fda-510k.jpg K021615 - BAXTER ACCURA SYSTEM, MODEL 5M5660 K021615 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Nov 2002. https://www.510kdatabase.net/k023337/ 2002-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k023337-cre-pulmonary-balloon-dilatation-fda-510k.jpg K023337 - CRE PULMONARY BALLOON DILATATION CATHETER, MODELS K00550300, M00550310, M00550320, M00550330, M00550340, M00550350 K023337 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Boston Scientific Corp. Cleared Nov 2002. https://www.510kdatabase.net/k023679/ 2002-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k023679-gore-30t-torso-array-fda-510k.jpg K023679 - GORE 3.0T TORSO ARRAY K023679 is a FDA 510(k) cleared radiology medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Nov 2002. https://www.510kdatabase.net/k020703/ 2002-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k020703-scorpio-cr-and-ps-co-cr-femoral-fda-510k.jpg K020703 - SCORPIO CR AND PS CO CR FEMORAL COMPONENTS WITH TITANIUM PLASMA SPRAY COATING K020703 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Nov 2002. https://www.510kdatabase.net/k022059/ 2002-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k022059-microvasive-pulmonary-guidewire-fda-510k.jpg K022059 - MICROVASIVE PULMONARY GUIDEWIRE K022059 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Boston Scientific Corp. Cleared Nov 2002. https://www.510kdatabase.net/k022791/ 2002-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k022791-synthes-anterior-tension-band-atb-system-fda-510k.jpg K022791 - SYNTHES ANTERIOR TENSION BAND (ATB) SYSTEM K022791 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Nov 2002. https://www.510kdatabase.net/k023453/ 2002-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k023453-depuy-summit-fx-cemented-hip-prosthesis-fda-510k.jpg K023453 - DEPUY SUMMIT FX CEMENTED HIP PROSTHESIS K023453 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Nov 2002. https://www.510kdatabase.net/k023504/ 2002-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k023504-modification-to-atb-all-terrain-fda-510k.jpg K023504 - MODIFICATION TO ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER K023504 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Nov 2002. https://www.510kdatabase.net/k023646/ 2002-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k023646-exatech-acumatch-integrated-hip-system-fda-510k.jpg K023646 - EXATECH ACUMATCH INTEGRATED HIP SYSTEM C-SERIES CEMENTED FEMORAL STEM K023646 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Nov 2002. https://www.510kdatabase.net/k022574/ 2002-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k022574-intuitive-surgical-endoscopic-fda-510k.jpg K022574 - INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEM & ENDOSCOPIC INSTRUMENTS, MODEL DA VINCI ISI 1000/1200 K022574 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Nov 2002. https://www.510kdatabase.net/k023301/ 2002-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k023301-bd-phoenix-automated-microbiology-system-fda-510k.jpg K023301 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM K023301 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Nov 2002. https://www.510kdatabase.net/k023444/ 2002-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k023444-bd-phoenix-automated-microbiology-fda-510k.jpg K023444 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMIKACIN-0.5-64 UG/ML K023444 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Nov 2002. https://www.510kdatabase.net/k021477/ 2002-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k021477-preclude-mvp-dura-substitute-fda-510k.jpg K021477 - PRECLUDE MVP DURA SUBSTITUTE K021477 is a FDA 510(k) cleared neurology medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Nov 2002. https://www.510kdatabase.net/k022672/ 2002-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k022672-columbus-total-knee-system-cr-fda-510k.jpg K022672 - COLUMBUS TOTAL KNEE SYSTEM (CR) K022672 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aesculap, Inc.. Cleared Nov 2002. https://www.510kdatabase.net/k023409/ 2002-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k023409-ha-x-series-bi-metric-hip-femoral-fda-510k.jpg K023409 - HA X-SERIES BI-METRIC HIP FEMORAL COMPONENTS K023409 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Nov 2002. https://www.510kdatabase.net/k021434/ 2002-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k021434-arthrex-fiberwire-in-usp-sizes-fda-510k.jpg K021434 - ARTHREX FIBERWIRE IN USP SIZES K021434 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Arthrex, Inc.. Cleared Nov 2002. https://www.510kdatabase.net/k023048/ 2002-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k023048-modification-to-synchron-systems-fda-510k.jpg K023048 - MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE REAGENT K023048 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Nov 2002. https://www.510kdatabase.net/k023417/ 2002-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k023417-suretac-iii-models-7209900-7209901-fda-510k.jpg K023417 - SURETAC III, MODELS 7209900, 7209901 K023417 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Nov 2002. https://www.510kdatabase.net/k023557/ 2002-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k023557-centricity-pacs-plus-fda-510k.jpg K023557 - CENTRICITY PACS PLUS K023557 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Nov 2002. https://www.510kdatabase.net/k023402/ 2002-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k023402-8f-launcher-guide-catheter-fda-510k.jpg K023402 - 8F LAUNCHER GUIDE CATHETER K023402 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Nov 2002. https://www.510kdatabase.net/k022036/ 2002-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k022036-siemens-virtual-simulation-vsim-fda-510k.jpg K022036 - SIEMENS VIRTUAL SIMULATION (VSIM) K022036 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2002. https://www.510kdatabase.net/k022629/ 2002-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k022629-wmt-tcp-bone-graft-substitute-fda-510k.jpg K022629 - WMT-TCP BONE GRAFT SUBSTITUTE K022629 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Nov 2002. https://www.510kdatabase.net/k023442/ 2002-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k023442-extra-large-body-coil-fda-510k.jpg K023442 - EXTRA LARGE BODY COIL K023442 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Nov 2002. https://www.510kdatabase.net/k023511/ 2002-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k023511-excelart-with-pianissimo-xgag-spin-fda-510k.jpg K023511 - EXCELART WITH PIANISSIMO XG/AG SPIN EDITION, MODEL MRT-1501/P3, P2 K023511 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Nov 2002. https://www.510kdatabase.net/k021467/ 2002-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k021467-autocon-ii-400-electrosurgical-generator-fda-510k.jpg K021467 - AUTOCON II 400 ELECTROSURGICAL GENERATOR K021467 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Nov 2002. https://www.510kdatabase.net/k023432/ 2002-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k023432-medline-asep-plus-surgical-drapes-fda-510k.jpg K023432 - MEDLINE ASEP PLUS SURGICAL DRAPES K023432 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Nov 2002. https://www.510kdatabase.net/k023569/ 2002-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k023569-siemens-multiview-workstation-fda-510k.jpg K023569 - SIEMENS MULTIVIEW WORKSTATION MODIFICATIONS K023569 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2002. https://www.510kdatabase.net/k022012/ 2002-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k022012-synthes-low-profile-neuro-system-fda-510k.jpg K022012 - SYNTHES LOW PROFILE NEURO SYSTEM K022012 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Nov 2002. https://www.510kdatabase.net/k023309/ 2002-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k023309-control-plasma-n-fda-510k.jpg K023309 - CONTROL PLASMA N K023309 is a FDA 510(k) cleared hematology medical device. Manufacturer: Dade Behring, Inc.. Cleared Nov 2002. https://www.510kdatabase.net/k023312/ 2002-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k023312-control-plasma-p-fda-510k.jpg K023312 - CONTROL PLASMA P K023312 is a FDA 510(k) cleared hematology medical device. Manufacturer: Dade Behring, Inc.. Cleared Nov 2002. https://www.510kdatabase.net/k023273/ 2002-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k023273-bd-phoenix-automated-microbiology-fda-510k.jpg K023273 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - GENTAMICIN 0.25 - 16 UG/ML K023273 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Oct 2002. https://www.510kdatabase.net/k023303/ 2002-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k023303-export-aspiration-catheter-fda-510k.jpg K023303 - EXPORT ASPIRATION CATHETER K023303 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Oct 2002. https://www.510kdatabase.net/k022612/ 2002-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k022612-ibond-gluma-inside-fda-510k.jpg K022612 - IBOND GLUMA INSIDE K022612 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Oct 2002. https://www.510kdatabase.net/k022941/ 2002-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k022941-medisense-precision-pcx-point-of-care-fda-510k.jpg K022941 - MEDISENSE PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM FOR BLOOD GLUCOSE TESTING K022941 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Oct 2002. https://www.510kdatabase.net/k021190/ 2002-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k021190-pt-s-test-strips-for-the-coaguchek-fda-510k.jpg K021190 - PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422 K021190 is a FDA 510(k) cleared hematology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Oct 2002. https://www.510kdatabase.net/k021306/ 2002-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k021306-vectorvision-ct-free-knee-fda-510k.jpg K021306 - VECTORVISION CT-FREE KNEE K021306 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Oct 2002. https://www.510kdatabase.net/k021630/ 2002-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k021630-boston-scientific-express-biliary-ld-fda-510k.jpg K021630 - BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM K021630 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Oct 2002. https://www.510kdatabase.net/k021728/ 2002-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k021728-ringloc-constrained-liners-ii-fda-510k.jpg K021728 - RINGLOC CONSTRAINED LINERS II K021728 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Oct 2002. https://www.510kdatabase.net/k023217/ 2002-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k023217-modification-to-smart-control-nitinol-fda-510k.jpg K023217 - MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM K023217 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Oct 2002. https://www.510kdatabase.net/k023302/ 2002-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k023302-echelon-porous-plus-ha-hip-stems-fda-510k.jpg K023302 - ECHELON POROUS PLUS HA HIP STEMS K023302 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 2002. https://www.510kdatabase.net/k020831/ 2002-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k020831-pt-s-test-strips-and-controls-for-the-fda-510k.jpg K020831 - PT S TEST STRIPS AND CONTROLS FOR THE COAGUCHEK S SYSTEM, MODELS 2032422 AND 3271404 K020831 is a FDA 510(k) cleared hematology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Oct 2002. https://www.510kdatabase.net/k023190/ 2002-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k023190-ecam-computer-esoft-workstation-fda-510k.jpg K023190 - E.CAM COMPUTER / E.SOFT WORKSTATION K023190 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 2002. https://www.510kdatabase.net/k023475/ 2002-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k023475-cns-9700-series-central-nurse-station-fda-510k.jpg K023475 - CNS-9700 SERIES CENTRAL NURSE STATION AND ACCESSORIES K023475 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Oct 2002. https://www.510kdatabase.net/k023332/ 2002-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k023332-lightspeed-ultra-computed-tomography-fda-510k.jpg K023332 - LIGHTSPEED ULTRA COMPUTED TOMOGRAPHY SYSTEM WITH WIDE-VIEW K023332 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Oct 2002. https://www.510kdatabase.net/k022942/ 2002-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k022942-craniocut-fda-510k.jpg K022942 - CRANIOCUT K022942 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Oct 2002. https://www.510kdatabase.net/k021451/ 2002-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k021451-duracon-cs-tibial-insert-fda-510k.jpg K021451 - DURACON CS TIBIAL INSERT K021451 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Oct 2002. https://www.510kdatabase.net/k023092/ 2002-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k023092-bd-k-4000-microkeratome-system-fda-510k.jpg K023092 - BD K-4000 MICROKERATOME SYSTEM K023092 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Becton, Dickinson & CO. Cleared Oct 2002. https://www.510kdatabase.net/k023116/ 2002-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k023116-cordis-optease-permanent-vena-cava-fda-510k.jpg K023116 - CORDIS OPTEASE PERMANENT VENA CAVA FILTER, MODELS 466-F200A, 466-F200B K023116 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Oct 2002. https://www.510kdatabase.net/k021815/ 2002-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k021815-smith-nephew-image-surgical-fda-510k.jpg K021815 - SMITH & NEPHEW IMAGE SURGICAL INSTRUMENTS FOR TRAUMA APPLICATIONS K021815 is a FDA 510(k) cleared neurology medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 2002. https://www.510kdatabase.net/k022403/ 2002-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k022403-gmrs-press-fit-stems-with-purefix-ha-fda-510k.jpg K022403 - GMRS PRESS FIT STEMS WITH PUREFIX HA K022403 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Oct 2002. https://www.510kdatabase.net/k022651/ 2002-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k022651-hoffmann-30-degree-pelvic-double-ball-fda-510k.jpg K022651 - HOFFMANN 30 DEGREE PELVIC DOUBLE BALL JOINT K022651 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Oct 2002. https://www.510kdatabase.net/k023186/ 2002-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k023186-optetrak-total-knee-system-offset-fda-510k.jpg K023186 - OPTETRAK TOTAL KNEE SYSTEM OFFSET TIBIAL TRAY K023186 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Oct 2002. https://www.510kdatabase.net/k023211/ 2002-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k023211-nexgen-complete-knee-solution-cruciate-fda-510k.jpg K023211 - NEXGEN COMPLETE KNEE SOLUTION CRUCIATE RETAINING (CR)-FLEX FEMORAL COMPONENTS K023211 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Oct 2002. https://www.510kdatabase.net/k023270/ 2002-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k023270-sas-strepalert-fda-510k.jpg K023270 - SAS STREPALERT K023270 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Oct 2002. https://www.510kdatabase.net/k023291/ 2002-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k023291-cobra-cooled-cardiac-surgical-probe-fda-510k.jpg K023291 - COBRA COOLED CARDIAC SURGICAL PROBE, MODEL 1596X K023291 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Boston Scientific Corp. Cleared Oct 2002. https://www.510kdatabase.net/k022637/ 2002-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k022637-bd-3000-microkeratome-system-model-k-fda-510k.jpg K022637 - BD-3000 MICROKERATOME SYSTEM, MODEL K-3000 MICROKERATOME K022637 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Becton, Dickinson & CO. Cleared Oct 2002. https://www.510kdatabase.net/k023065/ 2002-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k023065-cyclosporine-csa-flex-reagent-cartridge-fda-510k.jpg K023065 - CYCLOSPORINE (CSA) FLEX REAGENT CARTRIDGE K023065 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Oct 2002. https://www.510kdatabase.net/k022117/ 2002-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k022117-majestik-tm-shielded-angiography-fda-510k.jpg K022117 - MAJESTIK (TM) SHIELDED ANGIOGRAPHY NEEDLE, MODEL STAN18T71W-25, MAJESTIK (TM) SHIELDED ANGIOGTAPHY NEEDLE, SRAN18T71WR-5 K022117 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Oct 2002. https://www.510kdatabase.net/k022757/ 2002-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k022757-spife-ck-kit-model-3332-3333-fda-510k.jpg K022757 - SPIFE CK KIT, MODEL 3332, 3333 K022757 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Oct 2002. https://www.510kdatabase.net/k023052/ 2002-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k023052-acuity-radiation-therapy-simulator-fda-510k.jpg K023052 - ACUITY RADIATION THERAPY SIMULATOR K023052 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Oct 2002. https://www.510kdatabase.net/k020948/ 2002-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k020948-smith-nephew-suretac-expanded-fda-510k.jpg K020948 - SMITH & NEPHEW SURETAC - EXPANDED INDICATIONS II K020948 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 2002. https://www.510kdatabase.net/k022238/ 2002-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k022238-myocardial-lead-implant-tool-model-10626-fda-510k.jpg K022238 - MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626 K022238 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Oct 2002. https://www.510kdatabase.net/k022580/ 2002-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k022580-bacton-dickinson-latitude-blood-fda-510k.jpg K022580 - BACTON DICKINSON LATITUDE BLOOD GLUCOSE MONITORING SYSTEM K022580 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Becton, Dickinson & CO. Cleared Oct 2002. https://www.510kdatabase.net/k022581/ 2002-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k022581-becton-dickinson-logic-blood-glucose-fda-510k.jpg K022581 - BECTON DICKINSON LOGIC BLOOD GLUCOSE MONITORING SYSTEM K022581 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Becton, Dickinson & CO. Cleared Oct 2002. https://www.510kdatabase.net/k023102/ 2002-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k023102-accolade-tmzf-plus-ha-127-size-0-hip-fda-510k.jpg K023102 - ACCOLADE TMZF PLUS HA 127 SIZE 0 HIP STEM K023102 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Oct 2002. https://www.510kdatabase.net/k023134/ 2002-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k023134-jet-x-tin-coated-half-pins-fda-510k.jpg K023134 - JET-X TIN COATED HALF PINS K023134 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 2002. https://www.510kdatabase.net/k023207/ 2002-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k023207-opart-including-opart-ultra-and-ultra-fda-510k.jpg K023207 - OPART (INCLUDING OPART ULTRA AND ULTRA GRADIENT UPGRADE KIT) K023207 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Oct 2002. https://www.510kdatabase.net/k023294/ 2002-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k023294-bosworth-coraco-clavicular-screw-fda-510k.jpg K023294 - BOSWORTH CORACO-CLAVICULAR SCREW K023294 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Oct 2002. https://www.510kdatabase.net/k023021/ 2002-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k023021-modification-to-smith-nephew-twinfix-fda-510k.jpg K023021 - MODIFICATION TO SMITH & NEPHEW TWINFIX TI QUICK T K023021 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 2002. https://www.510kdatabase.net/k023049/ 2002-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k023049-synchron-lx-i-725-clinical-system-fda-510k.jpg K023049 - SYNCHRON LX I 725 CLINICAL SYSTEM K023049 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Oct 2002. https://www.510kdatabase.net/k020810/ 2002-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k020810-vidas-d-dimer-new-dd2-assay-model30-442-fda-510k.jpg K020810 - VIDAS D-DIMER NEW (DD2) ASSAY MODEL#30 442 K020810 is a FDA 510(k) cleared hematology medical device. Manufacturer: bioMerieux, Inc.. Cleared Oct 2002. https://www.510kdatabase.net/k022234/ 2002-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k022234-arthrex-wrist-bio-anchor-model-ar-1322b-fda-510k.jpg K022234 - ARTHREX WRIST BIO-ANCHOR, MODEL AR-1322B K022234 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Oct 2002. https://www.510kdatabase.net/k023053/ 2002-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k023053-dyonics-vision-635-image-management-fda-510k.jpg K023053 - DYONICS VISION 635 IMAGE MANAGEMENT SYSTEM K023053 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 2002. https://www.510kdatabase.net/k022902/ 2002-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k022902-smith-nephew-hip-system-fda-510k.jpg K022902 - SMITH & NEPHEW HIP SYSTEM K022902 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 2002. https://www.510kdatabase.net/k022958/ 2002-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k022958-total-hip-femoral-heads-and-liners-fda-510k.jpg K022958 - TOTAL HIP FEMORAL HEADS AND LINERS K022958 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 2002. https://www.510kdatabase.net/k023088/ 2002-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k023088-bone-graft-syringe-model-8600-00x0-fda-510k.jpg K023088 - BONE GRAFT SYRINGE, MODEL 8600-00X0 K023088 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Oct 2002. https://www.510kdatabase.net/k022455/ 2002-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k022455-spife-ld-12-kit-model-3338-fda-510k.jpg K022455 - SPIFE LD-12 KIT, MODEL 3338 K022455 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Oct 2002. https://www.510kdatabase.net/k013837/ 2002-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k013837-bio-rad-platelia-toxo-igm-tmb-fda-510k.jpg K013837 - BIO-RAD PLATELIA TOXO IGM TMB K013837 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bio-Rad. Cleared Sep 2002. https://www.510kdatabase.net/k013839/ 2002-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k013839-bio-rad-platelia-toxo-igg-tmb-fda-510k.jpg K013839 - BIO-RAD PLATELIA TOXO IGG TMB K013839 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bio-Rad. Cleared Sep 2002. https://www.510kdatabase.net/k021814/ 2002-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k021814-accutni-and-accutni-calibrators-on-the-fda-510k.jpg K021814 - ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL #33340, 33345 K021814 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Sep 2002. https://www.510kdatabase.net/k022552/ 2002-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k022552-atb-all-terrain-balloon-pta-dilatation-fda-510k.jpg K022552 - ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER K022552 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Sep 2002. https://www.510kdatabase.net/k022889/ 2002-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k022889-siemens-infinity-modular-monitors-fda-510k.jpg K022889 - SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 & SC 9000XL & SIEMENS INFINITY EXPLORER K022889 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 2002. https://www.510kdatabase.net/k022983/ 2002-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k022983-bardport-x-port-isp-port-fda-510k.jpg K022983 - BARDPORT X-PORT ISP PORT K022983 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Sep 2002. https://www.510kdatabase.net/k022079/ 2002-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k022079-short-and-long-soft-tissue-attachment-fda-510k.jpg K022079 - SHORT AND LONG SOFT TISSUE ATTACHMENT K022079 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Sep 2002. https://www.510kdatabase.net/k022549/ 2002-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k022549-restoration-modular-system-fda-510k.jpg K022549 - RESTORATION MODULAR SYSTEM K022549 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Sep 2002. https://www.510kdatabase.net/k022676/ 2002-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k022676-orthoguard-ab-antimicrobial-sleeve-fda-510k.jpg K022676 - ORTHOGUARD AB ANTIMICROBIAL SLEEVE K022676 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Sep 2002. https://www.510kdatabase.net/k021648/ 2002-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k021648-quanta-lite-actin-anti-smooth-muscle-fda-510k.jpg K021648 - QUANTA LITE ACTIN (ANTI-SMOOTH MUSCLE) ELISA K021648 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Sep 2002. https://www.510kdatabase.net/k022132/ 2002-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k022132-servo-ventilator-system-model-64-87-fda-510k.jpg K022132 - SERVO VENTILATOR SYSTEM, MODEL 64 87 800 E407E K022132 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 2002. https://www.510kdatabase.net/k022919/ 2002-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k022919-smart-breath-respiratory-compensation-fda-510k.jpg K022919 - SMART BREATH RESPIRATORY COMPENSATION OPTION K022919 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Sep 2002. https://www.510kdatabase.net/k020255/ 2002-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k020255-riwo-net-operating-operating-control-fda-510k.jpg K020255 - RIWO NET OPERATING OPERATING CONTROL SYSTEM, MODEL #5590 K020255 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Sep 2002. https://www.510kdatabase.net/k021761/ 2002-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k021761-premier-anterior-cervical-plate-system-fda-510k.jpg K021761 - PREMIER ANTERIOR CERVICAL PLATE SYSTEM K021761 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Sep 2002. https://www.510kdatabase.net/k022991/ 2002-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k022991-liquichek-immunology-control-level-1-2-fda-510k.jpg K022991 - LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, AND 3-1 ML, MODEL 591, 592, 593 K022991 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Sep 2002. https://www.510kdatabase.net/k022135/ 2002-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k022135-ureteral-access-sheath-set-uass-fda-510k.jpg K022135 - URETERAL ACCESS SHEATH SET (UASS) K022135 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Sep 2002. https://www.510kdatabase.net/k022269/ 2002-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k022269-coated-vicryl-polyglactin-910-suture-fda-510k.jpg K022269 - COATED VICRYL* (POLYGLACTIN 910) SUTURE K022269 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Sep 2002. https://www.510kdatabase.net/k022339/ 2002-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k022339-total-bilirubin-fda-510k.jpg K022339 - TOTAL BILIRUBIN K022339 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Sep 2002. https://www.510kdatabase.net/k022872/ 2002-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k022872-ge-road-warrior-pet-ct-imaging-system-fda-510k.jpg K022872 - GE ROAD WARRIOR PET CT IMAGING SYSTEM K022872 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Sep 2002. https://www.510kdatabase.net/k022875/ 2002-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k022875-modification-to-bd-vacutainer-push-fda-510k.jpg K022875 - MODIFICATION TO BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET K022875 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Becton, Dickinson & CO. Cleared Sep 2002. https://www.510kdatabase.net/k022158/ 2002-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k022158-iqm-intelligent-quality-management-on-fda-510k.jpg K022158 - IQM (INTELLIGENT QUALITY MANAGEMENT) ON THE GEM PREMIER 3000, CVP (CALIBRATION VALIDATION PRODUCT) K022158 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 2002. https://www.510kdatabase.net/k022782/ 2002-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k022782-dualmesh-emerge-emerge-plus-biomaterial-fda-510k.jpg K022782 - DUALMESH EMERGE & EMERGE PLUS BIOMATERIAL K022782 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Sep 2002. https://www.510kdatabase.net/k020631/ 2002-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k020631-iplan-fda-510k.jpg K020631 - IPLAN K020631 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Sep 2002. https://www.510kdatabase.net/k021218/ 2002-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k021218-elecsys-cortisol-test-system-fda-510k.jpg K021218 - ELECSYS CORTISOL TEST SYSTEM K021218 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Sep 2002. https://www.510kdatabase.net/k022182/ 2002-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k022182-medisense-precision-easyblood-glucose-fda-510k.jpg K022182 - MEDISENSE PRECISION EASYBLOOD GLUCOSE MONITORING SYSTEM, MEDISENSE OPTIUM EASYBLOOD GLUCOSE MONITORING SYSTEM K022182 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Sep 2002. https://www.510kdatabase.net/k011531/ 2002-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k011531-calcium-phosphate-granular-bone-void-fda-510k.jpg K011531 - CALCIUM PHOSPHATE GRANULAR BONE VOID FILLER K011531 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Sep 2002. https://www.510kdatabase.net/k020345/ 2002-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k020345-arthrex-univers-fracture-prosthesis-fda-510k.jpg K020345 - ARTHREX UNIVERS FRACTURE PROSTHESIS K020345 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Sep 2002. https://www.510kdatabase.net/k021928/ 2002-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k021928-synthes-usa-resorbable-fixation-system-fda-510k.jpg K021928 - SYNTHES (USA) RESORBABLE FIXATION SYSTEM K021928 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Sep 2002. https://www.510kdatabase.net/k021932/ 2002-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k021932-synthes-65-mm-cannulated-screw-fda-510k.jpg K021932 - SYNTHES 6.5 MM CANNULATED SCREW K021932 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Sep 2002. https://www.510kdatabase.net/k022180/ 2002-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k022180-direct-bilirubin-fda-510k.jpg K022180 - DIRECT BILIRUBIN K022180 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Sep 2002. https://www.510kdatabase.net/k022669/ 2002-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k022669-8-channel-cardiac-phased-array-coil-fda-510k.jpg K022669 - 8 CHANNEL CARDIAC PHASED ARRAY COIL K022669 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Sep 2002. https://www.510kdatabase.net/k022796/ 2002-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k022796-cercon-ceram-s-porcelain-fda-510k.jpg K022796 - CERCON CERAM S PORCELAIN K022796 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Sep 2002. https://www.510kdatabase.net/k021891/ 2002-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k021891-zimmer-trabecular-metal-modular-fda-510k.jpg K021891 - ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM K021891 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Sep 2002. https://www.510kdatabase.net/k022648/ 2002-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k022648-endovive-initial-placement-direct-pej-fda-510k.jpg K022648 - ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, MODELS 6520 & 6521 K022648 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Sep 2002. https://www.510kdatabase.net/k022766/ 2002-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k022766-siemens-medical-information-bus-mibmib-fda-510k.jpg K022766 - SIEMENS MEDICAL INFORMATION BUS (MIB/MIB II/MIB DUO) PROTOCOL COVERTER K022766 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 2002. https://www.510kdatabase.net/k021906/ 2002-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k021906-quinton-q-cath-model-000460-fda-510k.jpg K021906 - QUINTON Q-CATH, MODEL 000460 K021906 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Sep 2002. https://www.510kdatabase.net/k022621/ 2002-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k022621-boston-scientific-imager-ii-4f-fda-510k.jpg K022621 - BOSTON SCIENTIFIC IMAGER II 4F SELECTIVE ANGIOGRAPHIC CATHETER K022621 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Sep 2002. https://www.510kdatabase.net/k002612/ 2002-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k002612-bardex-icplus-foley-catheter-with-fda-510k.jpg K002612 - BARDEX I.C.PLUS FOLEY CATHETER WITH SILVER SALTS IN HYDROGEL COATING, MODEL 3CC BALLOON: 17008,170010,5CC BALLOON K002612 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Sep 2002. https://www.510kdatabase.net/k022005/ 2002-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k022005-synthes-midface-distractor-fda-510k.jpg K022005 - SYNTHES MIDFACE DISTRACTOR K022005 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Sep 2002. https://www.510kdatabase.net/k021162/ 2002-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k021162-amax-density-coagulation-analyzer-amax-fda-510k.jpg K021162 - AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED K021162 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Aug 2002. https://www.510kdatabase.net/k022654/ 2002-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k022654-modification-to-elecsys-ck-mb-stat-fda-510k.jpg K022654 - MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB K022654 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Aug 2002. https://www.510kdatabase.net/k020550/ 2002-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k020550-passport-2-with-view-12-ecg-analysis-fda-510k.jpg K020550 - PASSPORT 2 WITH VIEW 12 ECG ANALYSIS MODULE MODEL # 0998-00-0170-XXXX K020550 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Aug 2002. https://www.510kdatabase.net/k020785/ 2002-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k020785-introcan-safety-iv-catheter-fda-510k.jpg K020785 - INTROCAN SAFETY IV CATHETER K020785 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Aug 2002. https://www.510kdatabase.net/k021804/ 2002-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k021804-precision-plus-tuna-office-system-fda-510k.jpg K021804 - PRECISION PLUS TUNA OFFICE SYSTEM K021804 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medtronic Vascular. Cleared Aug 2002. https://www.510kdatabase.net/k022556/ 2002-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k022556-reflection-modified-acetabular-shells-fda-510k.jpg K022556 - REFLECTION MODIFIED ACETABULAR SHELLS K022556 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Aug 2002. https://www.510kdatabase.net/k022764/ 2002-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k022764-7f-launcher-guide-catheter-fda-510k.jpg K022764 - 7F LAUNCHER GUIDE CATHETER K022764 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Aug 2002. https://www.510kdatabase.net/k022290/ 2002-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k022290-protein-s-ac-fda-510k.jpg K022290 - PROTEIN S AC K022290 is a FDA 510(k) cleared hematology medical device. Manufacturer: Dade Behring, Inc.. Cleared Aug 2002. https://www.510kdatabase.net/k022550/ 2002-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k022550-coamatic-lr-antithrombin-note-lrliquid-fda-510k.jpg K022550 - COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS K022550 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Aug 2002. https://www.510kdatabase.net/k021786/ 2002-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k021786-titanium-ankle-arthrodesis-nail-fda-510k.jpg K021786 - TITANIUM ANKLE ARTHRODESIS NAIL K021786 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Aug 2002. https://www.510kdatabase.net/k021791/ 2002-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k021791-verte-stack-spinal-system-fda-510k.jpg K021791 - VERTE-STACK SPINAL SYSTEM K021791 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Aug 2002. https://www.510kdatabase.net/k021933/ 2002-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k021933-tempfix-external-fixation-system-fda-510k.jpg K021933 - TEMPFIX EXTERNAL FIXATION SYSTEM K021933 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Aug 2002. https://www.510kdatabase.net/k022481/ 2002-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k022481-s2-tibial-nail-fda-510k.jpg K022481 - S2 TIBIAL NAIL K022481 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Aug 2002. https://www.510kdatabase.net/k022531/ 2002-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k022531-2mm-pediatric-flex-nail-fda-510k.jpg K022531 - 2MM PEDIATRIC FLEX NAIL K022531 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Aug 2002. https://www.510kdatabase.net/k022555/ 2002-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k022555-accolade-c-femoral-stems-fda-510k.jpg K022555 - ACCOLADE C FEMORAL STEMS K022555 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Aug 2002. https://www.510kdatabase.net/k022350/ 2002-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k022350-bard-crurasoft-patch-models-0116003-fda-510k.jpg K022350 - BARD CRURASOFT PATCH, MODELS 0116003 & 0116001 K022350 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Aug 2002. https://www.510kdatabase.net/k022561/ 2002-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k022561-catheter-repair-kit-with-replacement-fda-510k.jpg K022561 - CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 K022561 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Aug 2002. https://www.510kdatabase.net/k022397/ 2002-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k022397-signa-30t-magnetic-resonance-system-fda-510k.jpg K022397 - SIGNA 3.0T MAGNETIC RESONANCE SYSTEM K022397 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Aug 2002. https://www.510kdatabase.net/k022427/ 2002-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k022427-contour-se-microspheres-fda-510k.jpg K022427 - CONTOUR SE MICROSPHERES K022427 is a FDA 510(k) cleared neurology medical device. Manufacturer: Boston Scientific Corp. Cleared Aug 2002. https://www.510kdatabase.net/k022707/ 2002-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k022707-liquichek-urine-toxicology-control-fda-510k.jpg K022707 - LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1E, MODEL 438 K022707 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Aug 2002. https://www.510kdatabase.net/k022575/ 2002-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k022575-perfusor-compact-with-fm-system-fda-510k.jpg K022575 - PERFUSOR COMPACT WITH FM SYSTEM K022575 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Aug 2002. https://www.510kdatabase.net/k022603/ 2002-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k022603-immulite-1000-automated-immunoassay-fda-510k.jpg K022603 - IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER K022603 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Aug 2002. https://www.510kdatabase.net/k021805/ 2002-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k021805-seal-protect-protective-sealant-fda-510k.jpg K021805 - SEAL & PROTECT PROTECTIVE SEALANT K021805 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Aug 2002. https://www.510kdatabase.net/k022010/ 2002-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k022010-total-knee-femoral-component-fda-510k.jpg K022010 - TOTAL KNEE FEMORAL COMPONENT K022010 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Aug 2002. https://www.510kdatabase.net/k022460/ 2002-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k022460-smith-nephew-image-guided-surgical-fda-510k.jpg K022460 - SMITH & NEPHEW IMAGE GUIDED SURGICAL SYSTEM FOR KNEE APPLICATIONS K022460 is a FDA 510(k) cleared neurology medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Aug 2002. https://www.510kdatabase.net/k021765/ 2002-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k021765-cement-restrictor-small-and-large-fda-510k.jpg K021765 - CEMENT RESTRICTOR, SMALL AND LARGE K021765 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Aug 2002. https://www.510kdatabase.net/k021960/ 2002-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k021960-precision-point-of-care-blood-glucose-fda-510k.jpg K021960 - PRECISION POINT OF CARE BLOOD GLUCOSE TEST STRIP WITH TRUE MEASURE TECHNOLOGY K021960 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Aug 2002. https://www.510kdatabase.net/k022045/ 2002-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k022045-vitek-gram-positive-susceptibility-gps-fda-510k.jpg K022045 - VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR LINEZOLID K022045 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Aug 2002. https://www.510kdatabase.net/k022333/ 2002-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k022333-spife-lipporotein-12-model-3344-fda-510k.jpg K022333 - SPIFE LIPPOROTEIN-12, MODEL 3344 K022333 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Aug 2002. https://www.510kdatabase.net/k022525/ 2002-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k022525-liquichek-blood-gas-plus-co-oximeter-fda-510k.jpg K022525 - LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 AND 3, MODEL 507, 508, 509 K022525 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Aug 2002. https://www.510kdatabase.net/k022529/ 2002-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k022529-liquichek-blood-gas-plus-co-oximeter-fda-510k.jpg K022529 - LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS 1,2, AND 3, MODELS 667,668,669 K022529 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Aug 2002. https://www.510kdatabase.net/k021642/ 2002-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k021642-synthes-craniofacial-plates-fda-510k.jpg K021642 - SYNTHES CRANIOFACIAL PLATES K021642 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Aug 2002. https://www.510kdatabase.net/k021898/ 2002-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k021898-smart-control-nitinol-stent-fda-510k.jpg K021898 - SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM K021898 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Aug 2002. https://www.510kdatabase.net/k021920/ 2002-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k021920-70-fr-endobronchial-blocker-fda-510k.jpg K021920 - 7.0 FR. ENDOBRONCHIAL BLOCKER K021920 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Cook, Inc.. Cleared Aug 2002. https://www.510kdatabase.net/k022337/ 2002-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k022337-3d-navigation-interface-for-siremobile-fda-510k.jpg K022337 - 3D NAVIGATION INTERFACE FOR SIREMOBILE ISO-C 3D K022337 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 2002. https://www.510kdatabase.net/k022482/ 2002-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k022482-sensa-cuff-models-infant-child-adult-fda-510k.jpg K022482 - SENSA-CUFF, MODELS INFANT, CHILD, ADULT K022482 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Aug 2002. https://www.510kdatabase.net/k021583/ 2002-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k021583-patxfer-fda-510k.jpg K021583 - PATXFER K021583 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab AG. Cleared Aug 2002. https://www.510kdatabase.net/k021902/ 2002-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k021902-magellan-autologus-platelet-separator-fda-510k.jpg K021902 - MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET SEPARATOR DEISPOSABLE KIT, MKT300 K021902 is a FDA 510(k) cleared hematology medical device. Manufacturer: Medtronic Vascular. Cleared Aug 2002. https://www.510kdatabase.net/k022172/ 2002-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k022172-bd-phoenix-automated-microbiology-system-fda-510k.jpg K022172 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM K022172 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Aug 2002. https://www.510kdatabase.net/k021556/ 2002-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k021556-synthes-24-mm-cannulated-compression-fda-510k.jpg K021556 - SYNTHES 2.4 MM CANNULATED COMPRESSION SCREW K021556 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Aug 2002. https://www.510kdatabase.net/k013784/ 2002-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k013784-ureteral-stent-fda-510k.jpg K013784 - URETERAL STENT K013784 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Aug 2002. https://www.510kdatabase.net/k022426/ 2002-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k022426-bd-preset-blood-collection-syringe-bd-fda-510k.jpg K022426 - BD PRESET BLOOD COLLECTION SYRINGE, BD A-LINE BLOOD COLLECTION SYRINGE, MODELS 365313, 365323,365316,365356,365373,36538 K022426 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Becton, Dickinson & CO. Cleared Aug 2002. https://www.510kdatabase.net/k021877/ 2002-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k021877-mda-d-dimer-fda-510k.jpg K021877 - MDA D-DIMER K021877 is a FDA 510(k) cleared hematology medical device. Manufacturer: bioMerieux, Inc.. Cleared Aug 2002. https://www.510kdatabase.net/k022195/ 2002-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k022195-coamatic-at-400-fda-510k.jpg K022195 - COAMATIC AT-400 K022195 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Aug 2002. https://www.510kdatabase.net/k022400/ 2002-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k022400-ssa-700a-aplio-diagnostic-ultrasound-fda-510k.jpg K022400 - SSA-700A, APLIO DIAGNOSTIC ULTRASOUND SYSTEM K022400 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Aug 2002. https://www.510kdatabase.net/k020672/ 2002-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k020672-elecsys-anti-tg-test-system-fda-510k.jpg K020672 - ELECSYS ANTI-TG TEST SYSTEM K020672 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Aug 2002. https://www.510kdatabase.net/k022434/ 2002-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k022434-bard-ultraview-multiple-band-ligator-fda-510k.jpg K022434 - BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U K022434 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Aug 2002. https://www.510kdatabase.net/k020120/ 2002-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k020120-endovive-initial-placement-direct-pej-fda-510k.jpg K020120 - ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, ENDOVIVE STANDARD PROFILE BALLOON REPLACEMENT, MODELS 6520, 6521, 6220 K020120 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Aug 2002. https://www.510kdatabase.net/k022476/ 2002-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k022476-relyx-rmgip-fda-510k.jpg K022476 - RELYX RMGIP K022476 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Aug 2002. https://www.510kdatabase.net/k021954/ 2002-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k021954-bd-phoenix-automated-microbiology-fda-510k.jpg K021954 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CLINDAMYCIN 0.125-8.0MCG/ML K021954 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Aug 2002. https://www.510kdatabase.net/k022019/ 2002-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k022019-perifix-catheter-connector-fda-510k.jpg K022019 - PERIFIX CATHETER CONNECTOR K022019 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Aug 2002. https://www.510kdatabase.net/k022193/ 2002-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k022193-dinamap-procare-series-monitor-models-fda-510k.jpg K022193 - DINAMAP PROCARE SERIES MONITOR, MODELS 100N, 200N, 300N, 400N K022193 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Aug 2002. https://www.510kdatabase.net/k022203/ 2002-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k022203-abbott-lifecare-pca-3-infuser-model-fda-510k.jpg K022203 - ABBOTT LIFECARE PCA 3 INFUSER, MODEL 12384 K022203 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Aug 2002. https://www.510kdatabase.net/k014070/ 2002-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k014070-epoch-hip-prosthesis-model-4075-series-fda-510k.jpg K014070 - EPOCH HIP PROSTHESIS, MODEL 4075 SERIES K014070 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jul 2002. https://www.510kdatabase.net/k021482/ 2002-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k021482-quanta-lite-sla-soluble-liver-antigen-fda-510k.jpg K021482 - QUANTA LITE SLA (SOLUBLE LIVER ANTIGEN) ELISA K021482 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Jul 2002. https://www.510kdatabase.net/k021408/ 2002-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k021408-resorbable-cranial-clamps-fda-510k.jpg K021408 - RESORBABLE CRANIAL CLAMPS K021408 is a FDA 510(k) cleared neurology medical device. Manufacturer: Synthes (Usa). Cleared Jul 2002. https://www.510kdatabase.net/k021653/ 2002-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k021653-codman-bactiseal-evd-catheter-set-fda-510k.jpg K021653 - CODMAN BACTISEAL EVD CATHETER SET K021653 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Jul 2002. https://www.510kdatabase.net/k022121/ 2002-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k022121-psg-input-box-model-je-912ak-fda-510k.jpg K022121 - PSG INPUT BOX, MODEL JE-912AK K022121 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Jul 2002. https://www.510kdatabase.net/k022130/ 2002-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k022130-bd-vacutainer-plus-pst-ii-tube-fda-510k.jpg K022130 - BD VACUTAINER PLUS PST II TUBE K022130 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Becton, Dickinson & CO. Cleared Jul 2002. https://www.510kdatabase.net/k022161/ 2002-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k022161-modification-to-coulter-lh-750-fda-510k.jpg K022161 - MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632 K022161 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jul 2002. https://www.510kdatabase.net/k020046/ 2002-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k020046-multigas-unit-model-ag-920ra-fda-510k.jpg K020046 - MULTIGAS UNIT, MODEL AG-920RA K020046 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Jul 2002. https://www.510kdatabase.net/k021061/ 2002-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k021061-modification-to-cd-horizon-spinal-system-fda-510k.jpg K021061 - MODIFICATION TO CD HORIZON SPINAL SYSTEM K021061 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Jul 2002. https://www.510kdatabase.net/k021327/ 2002-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k021327-orthopilot-hto-module-fda-510k.jpg K021327 - ORTHOPILOT HTO MODULE K021327 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Jul 2002. https://www.510kdatabase.net/k022077/ 2002-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k022077-36mm-v40-femoral-head-components-lfit-fda-510k.jpg K022077 - 36MM V40 FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT) K022077 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jul 2002. https://www.510kdatabase.net/k022094/ 2002-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k022094-par-5-acetabular-component-with-fda-510k.jpg K022094 - PAR 5 ACETABULAR COMPONENT WITH & WITHOUT HYDROXYAPATITE COATING K022094 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jul 2002. https://www.510kdatabase.net/k022129/ 2002-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k022129-bd-phoenix-automated-microbiology-fda-510k.jpg K022129 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM MOXIFLOXACIN 0.125-8 UG/ML K022129 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Jul 2002. https://www.510kdatabase.net/k022255/ 2002-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k022255-modofocation-to-synthes-ankle-fda-510k.jpg K022255 - MODOFOCATION TO SYNTHES ANKLE ARTHRODESIS PLATES K022255 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jul 2002. https://www.510kdatabase.net/k021458/ 2002-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k021458-synthes-in-situ-bendercutter-fda-510k.jpg K021458 - SYNTHES IN-SITU BENDER/CUTTER K021458 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jul 2002. https://www.510kdatabase.net/k021499/ 2002-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k021499-cemvac-ultra-pre-packed-with-depuy-1-fda-510k.jpg K021499 - CEMVAC ULTRA PRE-PACKED WITH DEPUY 1 BONE CEMENT K021499 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jul 2002. https://www.510kdatabase.net/k012770/ 2002-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k012770-infinity-micro2-fda-510k.jpg K012770 - INFINITY MICRO2+ K012770 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 2002. https://www.510kdatabase.net/k022171/ 2002-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k022171-accu-chek-compact-system-fda-510k.jpg K022171 - ACCU-CHEK COMPACT SYSTEM K022171 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jul 2002. https://www.510kdatabase.net/k021313/ 2002-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k021313-search-evolution-total-knee-system-fda-510k.jpg K021313 - SEARCH EVOLUTION TOTAL KNEE SYSTEM K021313 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aesculap, Inc.. Cleared Jul 2002. https://www.510kdatabase.net/k021461/ 2002-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k021461-atlantis-vision-anterior-cervical-fda-510k.jpg K021461 - ATLANTIS VISION ANTERIOR CERVICAL PLATE SYSTEM K021461 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Jul 2002. https://www.510kdatabase.net/k022118/ 2002-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k022118-immulite-turbo-ck-mb-models-lskcp1-100-fda-510k.jpg K022118 - IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS) K022118 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jul 2002. https://www.510kdatabase.net/k014256/ 2002-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k014256-kolibri-igs-systems-fda-510k.jpg K014256 - KOLIBRI IGS SYSTEMS K014256 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Jul 2002. https://www.510kdatabase.net/k021572/ 2002-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k021572-synchron-systems-c-reactive-protein-c-fda-510k.jpg K021572 - SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) REAGENT K021572 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jul 2002. https://www.510kdatabase.net/k021326/ 2002-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k021326-vidas-testosterone-tes-model-30-418-fda-510k.jpg K021326 - VIDAS TESTOSTERONE (TES), MODEL 30 418 K021326 is a FDA 510(k) cleared chemistry medical device. Manufacturer: bioMerieux, Inc.. Cleared Jul 2002. https://www.510kdatabase.net/k020413/ 2002-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k020413-microscan-synergies-plus-dried-gram-fda-510k.jpg K020413 - MICROSCAN SYNERGIES PLUS DRIED GRAM NEGATIVE MIC/COMBO PANELS WITH CEFTAZIDIME (1-16 UG/ML) K020413 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Jul 2002. https://www.510kdatabase.net/k021505/ 2002-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k021505-online-dat-ii-methadone-ii-fda-510k.jpg K021505 - ONLINE DAT II METHADONE II K021505 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jul 2002. https://www.510kdatabase.net/k021512/ 2002-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k021512-cobas-integra-online-dat-ii-methadone-ii-fda-510k.jpg K021512 - COBAS INTEGRA ONLINE DAT II METHADONE II K021512 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jul 2002. https://www.510kdatabase.net/k021736/ 2002-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k021736-bard-ventralex-hernia-patch-models-fda-510k.jpg K021736 - BARD VENTRALEX HERNIA PATCH, MODELS 0010302, 0010301 K021736 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jul 2002. https://www.510kdatabase.net/k022013/ 2002-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k022013-lungcare-ct-software-package-fda-510k.jpg K022013 - LUNGCARE CT SOFTWARE PACKAGE K022013 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 2002. https://www.510kdatabase.net/k021582/ 2002-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k021582-bactec-mgit-960-pza-kit-fda-510k.jpg K021582 - BACTEC MGIT 960 PZA KIT K021582 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Jul 2002. https://www.510kdatabase.net/k020704/ 2002-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k020704-roche-online-gentamicin-fda-510k.jpg K020704 - ROCHE ONLINE GENTAMICIN K020704 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jul 2002. https://www.510kdatabase.net/k021874/ 2002-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k021874-abbott-q2-plus-s02continuous-cardiac-fda-510k.jpg K021874 - ABBOTT Q2 PLUS S02/CONTINUOUS CARDIAC OUTPUT COMPUTER, LIST NUMBER 56711 K021874 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Laboratories. Cleared Jul 2002. https://www.510kdatabase.net/k021927/ 2002-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k021927-platelet-concentrate-separation-kit-fda-510k.jpg K021927 - PLATELET CONCENTRATE SEPARATION KIT FOR CELSEP CENTRIFUGE SYSTEM K021927 is a FDA 510(k) cleared hematology medical device. Manufacturer: Biomet, Inc.. Cleared Jul 2002. https://www.510kdatabase.net/k012193/ 2002-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k012193-amc-antimicrobial-pinwire-sleeve-fda-510k.jpg K012193 - AMC ANTIMICROBIAL PIN/WIRE SLEEVE K012193 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 2002. https://www.510kdatabase.net/k013873/ 2002-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k013873-cobra-cardiac-electrosurgical-system-fda-510k.jpg K013873 - COBRA CARDIAC ELECTROSURGICAL SYSTEM K013873 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Boston Scientific Corp. Cleared Jul 2002. https://www.510kdatabase.net/k021903/ 2002-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k021903-kodak-x-omat-cassetteleadless-for-fda-510k.jpg K021903 - KODAK X-OMAT CASSETTE/LEADLESS FOR DENTAL USE K021903 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Jul 2002. https://www.510kdatabase.net/k014297/ 2002-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k014297-endovive-initial-placement-gastrostomy-fda-510k.jpg K014297 - ENDOVIVE INITIAL PLACEMENT GASTROSTOMY KIT K014297 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Jul 2002. https://www.510kdatabase.net/k021170/ 2002-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k021170-tsrh-spinal-system-fda-510k.jpg K021170 - TSRH SPINAL SYSTEM K021170 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Jul 2002. https://www.510kdatabase.net/k022050/ 2002-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k022050-cgs-31a-multislice-upgrade-kit-for-fda-510k.jpg K022050 - CGS-31A MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER. TSX-101A (AQUILION ADVANCE MULTI) K022050 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Jul 2002. https://www.510kdatabase.net/k021488/ 2002-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k021488-surecan-safety-huber-needle-infusion-fda-510k.jpg K021488 - SURECAN SAFETY HUBER NEEDLE INFUSION SETS K021488 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Jul 2002. https://www.510kdatabase.net/k021094/ 2002-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k021094-introcan-safety-iv-catheter-fda-510k.jpg K021094 - INTROCAN SAFETY IV CATHETER K021094 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Jul 2002. https://www.510kdatabase.net/k021827/ 2002-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k021827-modification-to-accu-chek-active-system-fda-510k.jpg K021827 - MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM K021827 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jul 2002. https://www.510kdatabase.net/k014255/ 2002-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k014255-dinamap-procare-series-monitor-fda-510k.jpg K014255 - DINAMAP PROCARE SERIES MONITOR K014255 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Jul 2002. https://www.510kdatabase.net/k021346/ 2002-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k021346-stem-hip-replacement-system-model-fda-510k.jpg K021346 - STEM HIP REPLACEMENT SYSTEM, MODEL PHA002XX K021346 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jul 2002. https://www.510kdatabase.net/k021829/ 2002-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k021829-modification-to-kodak-directview-cr-fda-510k.jpg K021829 - MODIFICATION TO KODAK DIRECTVIEW CR 800/900 SYSTEM K021829 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Jul 2002. https://www.510kdatabase.net/k021911/ 2002-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k021911-trident-crossfire-polyuethylene-liners-fda-510k.jpg K021911 - TRIDENT CROSSFIRE POLYUETHYLENE LINERS K021911 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jul 2002. https://www.510kdatabase.net/k011037/ 2002-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k011037-vertebral-spacer-fda-510k.jpg K011037 - VERTEBRAL SPACER K011037 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jul 2002. https://www.510kdatabase.net/k013182/ 2002-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k013182-triple-lumen-central-venous-catheter-fda-510k.jpg K013182 - TRIPLE LUMEN CENTRAL VENOUS CATHETER K013182 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cook, Inc.. Cleared Jul 2002. https://www.510kdatabase.net/k021071/ 2002-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k021071-pccs-graft-delivery-system-fda-510k.jpg K021071 - PCCS GRAFT DELIVERY SYSTEM K021071 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Biomet, Inc.. Cleared Jul 2002. https://www.510kdatabase.net/k021349/ 2002-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k021349-metal-transcend-articulation-system-fda-510k.jpg K021349 - METAL TRANSCEND ARTICULATION SYSTEM (LARGER SIZES) K021349 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jul 2002. https://www.510kdatabase.net/k021828/ 2002-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k021828-small-hammer-toe-pin-fda-510k.jpg K021828 - SMALL HAMMER TOE PIN K021828 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jul 2002. https://www.510kdatabase.net/k021229/ 2002-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k021229-myoglobin-and-myoglobin-calibrators-on-fda-510k.jpg K021229 - MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244 K021229 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jun 2002. https://www.510kdatabase.net/k021345/ 2002-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k021345-modification-to-cordis-palmaz-genesis-fda-510k.jpg K021345 - MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM K021345 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Jun 2002. https://www.510kdatabase.net/k020979/ 2002-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k020979-sysmex-automated-coagulation-analyzer-fda-510k.jpg K020979 - SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000 K020979 is a FDA 510(k) cleared hematology medical device. Manufacturer: Dade Behring, Inc.. Cleared Jun 2002. https://www.510kdatabase.net/k021036/ 2002-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k021036-intuitive-surgical-da-vinci-surgical-fda-510k.jpg K021036 - INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS1000 K021036 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Jun 2002. https://www.510kdatabase.net/k021050/ 2002-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k021050-ksea-neuroendoscopes-and-accessories-fda-510k.jpg K021050 - KSEA NEUROENDOSCOPES AND ACCESSORIES K021050 is a FDA 510(k) cleared neurology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jun 2002. https://www.510kdatabase.net/k021744/ 2002-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k021744-t2-femoral-nail-fda-510k.jpg K021744 - T2 FEMORAL NAIL K021744 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jun 2002. https://www.510kdatabase.net/k021832/ 2002-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k021832-arthrotek-resorbable-no-profile-fda-510k.jpg K021832 - ARTHROTEK RESORBABLE NO-PROFILE LACTOSORB L-15 SCREW & WASHER K021832 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jun 2002. https://www.510kdatabase.net/k020666/ 2002-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k020666-duploject-easy-prep-system-1ml-2ml-5ml-fda-510k.jpg K020666 - DUPLOJECT EASY-PREP SYSTEM 1ML, 2ML, 5ML K020666 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jun 2002. https://www.510kdatabase.net/k020980/ 2002-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k020980-dimension-tpsa-calibrator-model-rc459-fda-510k.jpg K020980 - DIMENSION TPSA CALIBRATOR, MODEL #RC459 K020980 is a FDA 510(k) cleared immunology medical device. Manufacturer: Dade Behring, Inc.. Cleared Jun 2002. https://www.510kdatabase.net/k021721/ 2002-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k021721-equalizer-balloon-catheter-fda-510k.jpg K021721 - EQUALIZER BALLOON CATHETER K021721 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Jun 2002. https://www.510kdatabase.net/k021861/ 2002-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k021861-remstar-pro-with-c-flex-cpap-system-fda-510k.jpg K021861 - REMSTAR PRO WITH C-FLEX CPAP SYSTEM K021861 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Jun 2002. https://www.510kdatabase.net/k021016/ 2002-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k021016-amx-4-plus-mobile-x-ray-system-fda-510k.jpg K021016 - AMX-4 PLUS MOBILE X-RAY SYSTEM K021016 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Jun 2002. https://www.510kdatabase.net/k014113/ 2002-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k014113-endomap-fda-510k.jpg K014113 - ENDOMAP K014113 is a FDA 510(k) cleared neurology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 2002. https://www.510kdatabase.net/k020991/ 2002-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k020991-syngo-mr-2002b-fda-510k.jpg K020991 - SYNGO MR 2002B K020991 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 2002. https://www.510kdatabase.net/k021593/ 2002-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k021593-modification-to-envoy-and-vista-brite-fda-510k.jpg K021593 - MODIFICATION TO ENVOY AND VISTA BRITE TIP K021593 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Jun 2002. https://www.510kdatabase.net/k020872/ 2002-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k020872-synthes-35-mm-broad-lc-dcp-plates-fda-510k.jpg K020872 - SYNTHES 3.5 MM BROAD LC-DCP PLATES K020872 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jun 2002. https://www.510kdatabase.net/k021715/ 2002-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k021715-cemex-rx-cemex-isoplastic-cemex-xl-fda-510k.jpg K021715 - CEMEX RX, CEMEX ISOPLASTIC & CEMEX XL K021715 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Jun 2002. https://www.510kdatabase.net/k020410/ 2002-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k020410-microscan-rapids-plus-gram-negative-fda-510k.jpg K020410 - MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH CEPHALOTHIN (2-64 UG/ML) K020410 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Jun 2002. https://www.510kdatabase.net/k021150/ 2002-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k021150-coulter-cellprep-fda-510k.jpg K021150 - COULTER CELLPREP K021150 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jun 2002. https://www.510kdatabase.net/k021513/ 2002-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k021513-accu-chek-advantage-module-fda-510k.jpg K021513 - ACCU-CHEK ADVANTAGE MODULE K021513 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jun 2002. https://www.510kdatabase.net/k021673/ 2002-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k021673-total-hip-femoral-head-1214-taper-fda-510k.jpg K021673 - TOTAL HIP FEMORAL HEAD - 12/14 TAPER K021673 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jun 2002. https://www.510kdatabase.net/k021381/ 2002-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k021381-modification-to-nt-rheumatology-fda-510k.jpg K021381 - MODIFICATION TO N/T RHEUMATOLOGY CONTROLS SL 1 & 2 K021381 is a FDA 510(k) cleared immunology medical device. Manufacturer: Dade Behring, Inc.. Cleared Jun 2002. https://www.510kdatabase.net/k021850/ 2002-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k021850-synthes-usa-13-mm-craniofacial-screws-fda-510k.jpg K021850 - SYNTHES (USA) 1.3 MM CRANIOFACIAL SCREWS K021850 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Jun 2002. https://www.510kdatabase.net/k014088/ 2002-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k014088-duploreach-fda-510k.jpg K014088 - DUPLOREACH K014088 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jun 2002. https://www.510kdatabase.net/k020830/ 2002-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k020830-scorpio-inset-patellar-component-fda-510k.jpg K020830 - SCORPIO INSET PATELLAR COMPONENT K020830 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jun 2002. https://www.510kdatabase.net/k020860/ 2002-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k020860-m3-micro-multileaf-collimator-fda-510k.jpg K020860 - M3 (MICRO-MULTILEAF COLLIMATOR) K020860 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab AG. Cleared Jun 2002. https://www.510kdatabase.net/k021021/ 2002-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k021021-modular-angiography-system-axiom-artis-fda-510k.jpg K021021 - MODULAR ANGIOGRAPHY SYSTEM AXIOM ARTIS K021021 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 2002. https://www.510kdatabase.net/k020772/ 2002-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k020772-omega-ii-system-fda-510k.jpg K020772 - OMEGA II SYSTEM K020772 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jun 2002. https://www.510kdatabase.net/k021260/ 2002-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k021260-reduced-size-oncology-salvage-system-fda-510k.jpg K021260 - REDUCED SIZE ONCOLOGY SALVAGE SYSTEM K021260 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jun 2002. https://www.510kdatabase.net/k021559/ 2002-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k021559-ascent-all-poly-ps-tibial-bearings-fda-510k.jpg K021559 - ASCENT ALL-POLY PS TIBIAL BEARINGS K021559 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jun 2002. https://www.510kdatabase.net/k021621/ 2002-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k021621-fixed-bearing-uni-component-fda-510k.jpg K021621 - FIXED BEARING UNI COMPONENT K021621 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jun 2002. https://www.510kdatabase.net/k021257/ 2002-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k021257-ana-line-blot-catalog-number-kalabi-20-fda-510k.jpg K021257 - ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) K021257 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jun 2002. https://www.510kdatabase.net/k021448/ 2002-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k021448-modification-to-accu-chek-active-system-fda-510k.jpg K021448 - MODIFICATION TO ACCU-CHEK ACTIVE SYSTEM K021448 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jun 2002. https://www.510kdatabase.net/k021206/ 2002-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k021206-immulite-2000-specific-allergens-fda-510k.jpg K021206 - IMMULITE 2000 SPECIFIC ALLERGENS K021206 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared May 2002. https://www.510kdatabase.net/k021208/ 2002-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k021208-immulite-2000-mixed-allergen-panels-fda-510k.jpg K021208 - IMMULITE 2000 MIXED ALLERGEN PANELS K021208 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared May 2002. https://www.510kdatabase.net/k021587/ 2002-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k021587-attain-lds-6216a-left-heart-delivery-fda-510k.jpg K021587 - ATTAIN LDS 6216A LEFT-HEART DELIVERY SYSTEM, MODEL 6216A K021587 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared May 2002. https://www.510kdatabase.net/k021589/ 2002-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k021589-attain-access-6218a-left-heart-fda-510k.jpg K021589 - ATTAIN ACCESS 6218A LEFT-HEART DELIVERY SYSTEM, MODEL 6218 K021589 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared May 2002. https://www.510kdatabase.net/k021384/ 2002-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k021384-liquichek-urine-toxicology-control-fda-510k.jpg K021384 - LIQUICHEK URINE TOXICOLOGY CONTROL LEVELS C1-C4, MODELS 441,442,443,444 K021384 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared May 2002. https://www.510kdatabase.net/k021411/ 2002-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k021411-liquichek-urine-toxicology-control-fda-510k.jpg K021411 - LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1, S2 & S3 MODELS 461, 462 & 463 K021411 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared May 2002. https://www.510kdatabase.net/k021414/ 2002-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k021414-liquichek-urine-toxicology-control-fda-510k.jpg K021414 - LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL S1 LOW OPIATE & S2 LOW OPIATE MODELS 466 & 467 K021414 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared May 2002. https://www.510kdatabase.net/k021415/ 2002-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k021415-liquichek-urine-toxicology-control-fda-510k.jpg K021415 - LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2 LOW OPIATE & C3 LOW OPIATE MODELS 468 & 469 K021415 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared May 2002. https://www.510kdatabase.net/k020640/ 2002-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k020640-ksea-scb-media-control-fda-510k.jpg K020640 - KSEA SCB MEDIA CONTROL K020640 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared May 2002. https://www.510kdatabase.net/k021380/ 2002-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k021380-oss-les-proximal-femoral-component-fda-510k.jpg K021380 - OSS LES PROXIMAL FEMORAL COMPONENT K021380 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared May 2002. https://www.510kdatabase.net/k021498/ 2002-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k021498-liquichek-cardiac-markers-control-lt-fda-510k.jpg K021498 - LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVEL K021498 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared May 2002. https://www.510kdatabase.net/k020321/ 2002-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k020321-bd-phoenix-automated-microbiology-system-fda-510k.jpg K020321 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM K020321 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared May 2002. https://www.510kdatabase.net/k020914/ 2002-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k020914-actalyke-xl-activated-clotting-time-fda-510k.jpg K020914 - ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770 K020914 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared May 2002. https://www.510kdatabase.net/k021268/ 2002-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k021268-eclipse-helios-option-fda-510k.jpg K021268 - ECLIPSE, HELIOS OPTION K021268 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared May 2002. https://www.510kdatabase.net/k021435/ 2002-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k021435-dinamap-pro-series-monitor-models-fda-510k.jpg K021435 - DINAMAP PRO SERIES MONITOR, MODELS 110N,210N,310N,410N K021435 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared May 2002. https://www.510kdatabase.net/k021310/ 2002-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k021310-36mm-c-taper-femoral-head-components-fda-510k.jpg K021310 - 36MM C-TAPER FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT) K021310 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared May 2002. https://www.510kdatabase.net/k020541/ 2002-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k020541-agility-ankle-revision-prosthesis-fda-510k.jpg K020541 - AGILITY ANKLE REVISION PROSTHESIS K020541 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared May 2002. https://www.510kdatabase.net/k020747/ 2002-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k020747-amsco-century-medium-sterilizer-26-x-26-fda-510k.jpg K020747 - AMSCO CENTURY MEDIUM STERILIZER 26 X 26 K020747 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared May 2002. https://www.510kdatabase.net/k021256/ 2002-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k021256-z3-guide-catheter-fda-510k.jpg K021256 - Z3 GUIDE CATHETER K021256 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared May 2002. https://www.510kdatabase.net/k021274/ 2002-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k021274-pain-mate-pain-management-system-with-fda-510k.jpg K021274 - PAIN-MATE PAIN MANAGEMENT SYSTEM WITH DUAL PORT 1+1, 2+2, MODELS 2C1718, 2C1719 K021274 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared May 2002. https://www.510kdatabase.net/k020398/ 2002-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k020398-microscan-synergies-plus-gram-negative-fda-510k.jpg K020398 - MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN (0.25-128 UG/ML) K020398 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared May 2002. https://www.510kdatabase.net/k021024/ 2002-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k021024-hemosil-high-abnormal-control-assayed-fda-510k.jpg K021024 - HEMOSIL HIGH ABNORMAL CONTROL ASSAYED K021024 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared May 2002. https://www.510kdatabase.net/k021232/ 2002-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k021232-constellation-catheters-model-8031m-fda-510k.jpg K021232 - CONSTELLATION CATHETERS, MODEL 8031M K021232 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared May 2002. https://www.510kdatabase.net/k021382/ 2002-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k021382-synthes-usa-automated-tack-driver-fda-510k.jpg K021382 - SYNTHES (USA) AUTOMATED TACK DRIVER K021382 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared May 2002. https://www.510kdatabase.net/k020842/ 2002-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k020842-ertapenem-10ug-bbl-sensi-disc-fda-510k.jpg K020842 - ERTAPENEM 10UG BBL SENSI-DISC K020842 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared May 2002. https://www.510kdatabase.net/k021022/ 2002-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k021022-hemosil-low-abnormal-controlled-assayed-fda-510k.jpg K021022 - HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED) K021022 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared May 2002. https://www.510kdatabase.net/k021023/ 2002-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k021023-hemosil-normal-control-assayed-fda-510k.jpg K021023 - HEMOSIL NORMAL CONTROL (ASSAYED) K021023 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared May 2002. https://www.510kdatabase.net/k021350/ 2002-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k021350-abbott-plum-a3-multichannel-infusion-fda-510k.jpg K021350 - ABBOTT PLUM A+3 MULTICHANNEL INFUSION PUMP, MODEL 12348 K021350 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared May 2002. https://www.510kdatabase.net/k020615/ 2002-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k020615-super-secur-fit-ha-hip-stems-and-super-fda-510k.jpg K020615 - SUPER SECUR-FIT HA HIP STEMS AND SUPER SECUR-FIT PLUS HA HIP STEMS K020615 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared May 2002. https://www.510kdatabase.net/k021182/ 2002-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k021182-radiolucent-colles-compressiondistractio-fda-510k.jpg K021182 - RADIOLUCENT COLLES COMPRESSION/DISTRACTION BAR K021182 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared May 2002. https://www.510kdatabase.net/k021226/ 2002-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k021226-modification-to-pyramid-anterior-plate-fda-510k.jpg K021226 - MODIFICATION TO PYRAMID ANTERIOR PLATE FIXATION SYSTEM K021226 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared May 2002. https://www.510kdatabase.net/k021416/ 2002-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k021416-aquasil-ultra-monophaseheavylv-smart-fda-510k.jpg K021416 - AQUASIL ULTRA MONOPHASE/HEAVY/LV SMART WETTING IMPRESSION MATERIAL K021416 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared May 2002. https://www.510kdatabase.net/k020692/ 2002-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k020692-emit-2000-vancomycin-assay-fda-510k.jpg K020692 - EMIT 2000 VANCOMYCIN ASSAY K020692 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Dade Behring, Inc.. Cleared May 2002. https://www.510kdatabase.net/k021413/ 2002-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k021413-aquasil-ultra-rigid-smart-wetting-fda-510k.jpg K021413 - AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL K021413 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared May 2002. https://www.510kdatabase.net/k020709/ 2002-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k020709-modification-to-cd-horizon-spinal-system-fda-510k.jpg K020709 - MODIFICATION TO CD HORIZON SPINAL SYSTEM K020709 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared May 2002. https://www.510kdatabase.net/k020724/ 2002-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k020724-dimension-automated-ldl-cholesterol-fda-510k.jpg K020724 - DIMENSION AUTOMATED LDL CHOLESTEROL FLEX REAGENTCARTRIDGE METHOD, MODEL DF131 K020724 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared May 2002. https://www.510kdatabase.net/k020820/ 2002-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k020820-microscan-microstep-plus-panel-new-fda-510k.jpg K020820 - MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - CEFUROXIME K020820 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared May 2002. https://www.510kdatabase.net/k021135/ 2002-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k021135-model-2120is-series-maternalfetal-fda-510k.jpg K021135 - MODEL 2120IS SERIES MATERNAL/FETAL MONITOR K021135 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared May 2002. https://www.510kdatabase.net/k020401/ 2002-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k020401-synthes-calcaneal-plate-fda-510k.jpg K020401 - SYNTHES CALCANEAL PLATE K020401 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared May 2002. https://www.510kdatabase.net/k020723/ 2002-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k020723-dimension-aldl-calibrator-model-dc131-fda-510k.jpg K020723 - DIMENSION ALDL CALIBRATOR, MODEL DC131 K020723 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared May 2002. https://www.510kdatabase.net/k020822/ 2002-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k020822-microscan-microstep-plus-panel-new-fda-510k.jpg K020822 - MICROSCAN MICROSTEP PLUS PANEL NEW ANTIMICROBIAL - VANCOMYCIN K020822 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared May 2002. https://www.510kdatabase.net/k020845/ 2002-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k020845-emit-2000-vancomycin-calibrators-fda-510k.jpg K020845 - EMIT 2000 VANCOMYCIN CALIBRATORS K020845 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Dade Behring, Inc.. Cleared May 2002. https://www.510kdatabase.net/k021410/ 2002-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k021410-aquasil-ultra-xlv-smart-wetting-fda-510k.jpg K021410 - AQUASIL ULTRA XLV SMART WETTING IMPRESSION MATERIAL K021410 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared May 2002. https://www.510kdatabase.net/k020384/ 2002-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k020384-t2-arthrodesis-nail-system-fda-510k.jpg K020384 - T2 ARTHRODESIS NAIL SYSTEM K020384 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared May 2002. https://www.510kdatabase.net/k020625/ 2002-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k020625-spife-20003000-alp-40-20-fda-510k.jpg K020625 - SPIFE 2000/3000 ALP 40, 20 K020625 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared May 2002. https://www.510kdatabase.net/k021037/ 2002-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k021037-microstrep-plus-panel-with-ampicillin-fda-510k.jpg K021037 - MICROSTREP PLUS PANEL WITH AMPICILLIN K021037 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared May 2002. https://www.510kdatabase.net/k021074/ 2002-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k021074-visera-cystovideoscope-olympus-cyf-fda-510k.jpg K021074 - VISERA CYSTOVIDEOSCOPE OLYMPUS CYF TYPE V/VA K021074 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus America, Inc.. Cleared May 2002. https://www.510kdatabase.net/k021073/ 2002-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k021073-visera-rhinlaryngovideoscope-olympus-fda-510k.jpg K021073 - VISERA RHINLARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V K021073 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Olympus America, Inc.. Cleared May 2002. https://www.510kdatabase.net/k020414/ 2002-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k020414-quanta-lite-ccp-elisa-fda-510k.jpg K020414 - QUANTA LITE CCP ELISA K020414 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Apr 2002. https://www.510kdatabase.net/k020989/ 2002-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k020989-super-eon-plus-femoral-stems-fda-510k.jpg K020989 - SUPER EON PLUS FEMORAL STEMS K020989 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Apr 2002. https://www.510kdatabase.net/k021123/ 2002-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k021123-bactalert-sn-culture-bottle-fda-510k.jpg K021123 - BACT/ALERT SN CULTURE BOTTLE K021123 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Apr 2002. https://www.510kdatabase.net/k013517/ 2002-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k013517-10600-deflectable-catheter-system-fda-510k.jpg K013517 - 10600 DEFLECTABLE CATHETER SYSTEM, MODEL 10600 K013517 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Apr 2002. https://www.510kdatabase.net/k021026/ 2002-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k021026-s2-femoral-nail-fda-510k.jpg K021026 - S2 FEMORAL NAIL K021026 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Apr 2002. https://www.510kdatabase.net/k021027/ 2002-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k021027-s2-tibial-nail-fda-510k.jpg K021027 - S2 TIBIAL NAIL K021027 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Apr 2002. https://www.510kdatabase.net/k020257/ 2002-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k020257-datascopes-8fr-alt-b-iab-fda-510k.jpg K020257 - DATASCOPE'S 8FR. ALT B IAB K020257 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Apr 2002. https://www.510kdatabase.net/k021103/ 2002-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k021103-modification-to-zeus-scientifics-fda-510k.jpg K021103 - MODIFICATION TO ZEUS SCIENTIFIC'S ATHENA MULTI-LYTE ANA TEST SYSTEM K021103 is a FDA 510(k) cleared immunology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Apr 2002. https://www.510kdatabase.net/k020505/ 2002-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k020505-synthes-translating-maxillary-distractor-fda-510k.jpg K020505 - SYNTHES TRANSLATING MAXILLARY DISTRACTOR K020505 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Apr 2002. https://www.510kdatabase.net/k013865/ 2002-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k013865-tip-deflrcting-endobronchial-blocker-fda-510k.jpg K013865 - TIP DEFLRCTING ENDOBRONCHIAL BLOCKER K013865 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Cook, Inc.. Cleared Apr 2002. https://www.510kdatabase.net/k020397/ 2002-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k020397-microscan-synergies-plus-gram-negative-fda-510k.jpg K020397 - MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH PIPERACILLIN (4-256 UG/ML) K020397 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Apr 2002. https://www.510kdatabase.net/k020589/ 2002-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k020589-3m-comply-1228-gas-plasma-indicator-tape-fda-510k.jpg K020589 - 3M COMPLY 1228 GAS PLASMA INDICATOR TAPE K020589 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Apr 2002. https://www.510kdatabase.net/k020610/ 2002-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k020610-lyphochek-whole-blood-metals-control-fda-510k.jpg K020610 - LYPHOCHEK WHOLE BLOOD METALS CONTROL MODEL # 527, 528, 529 K020610 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Apr 2002. https://www.510kdatabase.net/k020819/ 2002-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k020819-distal-radius-plating-system-fda-510k.jpg K020819 - DISTAL RADIUS PLATING SYSTEM K020819 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Apr 2002. https://www.510kdatabase.net/k014123/ 2002-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k014123-bactec-mgit-960-sire-kits-fda-510k.jpg K014123 - BACTEC MGIT 960 SIRE KITS K014123 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Apr 2002. https://www.510kdatabase.net/k021213/ 2002-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k021213-modification-to-hemashield-platinum-fda-510k.jpg K021213 - MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS K021213 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Apr 2002. https://www.510kdatabase.net/k020815/ 2002-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k020815-bactalert-fn-culture-bottle-fda-510k.jpg K020815 - BACT/ALERT FN CULTURE BOTTLE K020815 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Apr 2002. https://www.510kdatabase.net/k020923/ 2002-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k020923-bactalert-pf-culture-bottle-fda-510k.jpg K020923 - BACT/ALERT PF CULTURE BOTTLE K020923 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Apr 2002. https://www.510kdatabase.net/k020931/ 2002-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k020931-bactalert-sa-culture-bottle-fda-510k.jpg K020931 - BACT/ALERT SA CULTURE BOTTLE K020931 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Apr 2002. https://www.510kdatabase.net/k011793/ 2002-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k011793-ksea-fiberscope-fda-510k.jpg K011793 - KSEA FIBERSCOPE K011793 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Apr 2002. https://www.510kdatabase.net/k020319/ 2002-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k020319-microscan-synergies-plus-gram-negative-fda-510k.jpg K020319 - MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN/SULBACTAM (0.5/0.25-64/34 UG/ML) K020319 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Apr 2002. https://www.510kdatabase.net/k020813/ 2002-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k020813-bactalert-fa-culture-bottle-fda-510k.jpg K020813 - BACT/ALERT FA CULTURE BOTTLE K020813 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Apr 2002. https://www.510kdatabase.net/k020864/ 2002-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k020864-edwards-mc-tricuspid-annuloplasty-fda-510k.jpg K020864 - EDWARDS MC TRICUSPID ANNULOPLASTY SYSTEM, MODEL 4900 K020864 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Apr 2002. https://www.510kdatabase.net/k020947/ 2002-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k020947-modification-to-dyonics-intelijet-fda-510k.jpg K020947 - MODIFICATION TO DYONICS INTELIJET REUSABLE CANNULAS K020947 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Apr 2002. https://www.510kdatabase.net/k020152/ 2002-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k020152-synthes-vertebral-spacer-ti-fda-510k.jpg K020152 - SYNTHES VERTEBRAL SPACER TI K020152 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Apr 2002. https://www.510kdatabase.net/k020740/ 2002-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k020740-roche-online-theophylline-fda-510k.jpg K020740 - ROCHE ONLINE THEOPHYLLINE K020740 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Apr 2002. https://www.510kdatabase.net/k021046/ 2002-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k021046-cobra-cooled-surgical-probe-model-1596x-fda-510k.jpg K021046 - COBRA COOLED SURGICAL PROBE, MODEL 1596X K021046 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Boston Scientific Corp. Cleared Apr 2002. https://www.510kdatabase.net/k020134/ 2002-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k020134-spiral-radius-90-d-rodding-system-fda-510k.jpg K020134 - SPIRAL RADIUS 90-D RODDING SYSTEM K020134 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Apr 2002. https://www.510kdatabase.net/k020517/ 2002-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k020517-synthes-dual-opening-uss-fda-510k.jpg K020517 - SYNTHES DUAL-OPENING USS K020517 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Apr 2002. https://www.510kdatabase.net/k020878/ 2002-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k020878-lyphochek-hemostasis-models-798-799-fda-510k.jpg K020878 - LYPHOCHEK HEMOSTASIS, MODELS 798, 799 K020878 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bio-Rad. Cleared Apr 2002. https://www.510kdatabase.net/k020809/ 2002-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k020809-modification-to-cordis-palmaz-genesis-fda-510k.jpg K020809 - MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT K020809 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Apr 2002. https://www.510kdatabase.net/k020824/ 2002-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k020824-speedband-superview-super-7-injection-fda-510k.jpg K020824 - SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 AND 4238 K020824 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Apr 2002. https://www.510kdatabase.net/k002578/ 2002-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k002578-axillary-access-arterial-cannula-fda-510k.jpg K002578 - AXILLARY ACCESS ARTERIAL CANNULA K002578 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Apr 2002. https://www.510kdatabase.net/k020841/ 2002-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k020841-avon-patellar-component-fda-510k.jpg K020841 - AVON PATELLAR COMPONENT K020841 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Apr 2002. https://www.510kdatabase.net/k020728/ 2002-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k020728-miethke-shunt-system-fda-510k.jpg K020728 - MIETHKE SHUNT SYSTEM K020728 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Apr 2002. https://www.510kdatabase.net/k020765/ 2002-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k020765-microvasive-zero-tip-airway-retrieval-fda-510k.jpg K020765 - MICROVASIVE ZERO TIP AIRWAY RETRIEVAL BASKET, MODELS M00513200 AND M00513210 K020765 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Boston Scientific Corp. Cleared Apr 2002. https://www.510kdatabase.net/k013569/ 2002-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k013569-orthopilot-2-fda-510k.jpg K013569 - ORTHOPILOT 2 K013569 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Apr 2002. https://www.510kdatabase.net/k020323/ 2002-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k020323-bd-phoenix-automated-microbiology-system-fda-510k.jpg K020323 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM K020323 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Apr 2002. https://www.510kdatabase.net/k020773/ 2002-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k020773-long-length-gamma-nail-fda-510k.jpg K020773 - LONG LENGTH GAMMA NAIL K020773 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Apr 2002. https://www.510kdatabase.net/k020789/ 2002-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k020789-ge-vivid-3-expert-fda-510k.jpg K020789 - GE VIVID 3 EXPERT K020789 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Apr 2002. https://www.510kdatabase.net/k020970/ 2002-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k020970-modification-to-oncology-salvage-fda-510k.jpg K020970 - MODIFICATION TO ONCOLOGY SALVAGE SYSTEM (OSS) K020970 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Apr 2002. https://www.510kdatabase.net/k013106/ 2002-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k013106-2-piece-modular-hip-stem-fda-510k.jpg K013106 - 2 PIECE MODULAR HIP STEM K013106 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Apr 2002. https://www.510kdatabase.net/k020761/ 2002-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k020761-power-tek-ii-fda-510k.jpg K020761 - POWER TEK II K020761 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Apr 2002. https://www.510kdatabase.net/k020929/ 2002-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k020929-smartscore-35-fda-510k.jpg K020929 - SMARTSCORE 3.5 K020929 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Apr 2002. https://www.510kdatabase.net/k020043/ 2002-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k020043-40-mm-arthrex-bio-tendoesis-screw-fda-510k.jpg K020043 - 4.0 MM ARTHREX BIO-TENDOESIS SCREW, MODEL AR-1540B K020043 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Apr 2002. https://www.510kdatabase.net/k020682/ 2002-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k020682-bard-luminexx-6-fr-biliary-stent-and-fda-510k.jpg K020682 - BARD LUMINEXX 6 FR BILIARY STENT AND DELIVERY SYSTEM K020682 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 2002. https://www.510kdatabase.net/k020467/ 2002-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k020467-spife-ld-vis-isoenzyme-kit-models-3450-fda-510k.jpg K020467 - SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452 K020467 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Mar 2002. https://www.510kdatabase.net/k020650/ 2002-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k020650-modification-to-reflex-anterior-fda-510k.jpg K020650 - MODIFICATION TO REFLEX ANTERIOR CERVICAL PLATE SYSTEM K020650 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Mar 2002. https://www.510kdatabase.net/k020677/ 2002-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k020677-gamma-3-lag-screw-fda-510k.jpg K020677 - GAMMA 3 LAG SCREW K020677 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Mar 2002. https://www.510kdatabase.net/k020871/ 2002-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k020871-vitek-2-antimircrobial-susceptibility-fda-510k.jpg K020871 - VITEK 2 ANTIMIRCROBIAL SUSCEPTIBILITY TEST SYSTEM FOR LEVOFLOXACIN K020871 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Mar 2002. https://www.510kdatabase.net/k013984/ 2002-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k013984-immulite-br-ma-model-lkbr-fda-510k.jpg K013984 - IMMULITE BR-MA, MODEL #LKBR K013984 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Mar 2002. https://www.510kdatabase.net/k020441/ 2002-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k020441-emit-ii-plus-monoclonal-cocaine-fda-510k.jpg K020441 - EMIT II PLUS MONOCLONAL COCAINE METABOLITE ASSAY K020441 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Dade Behring, Inc.. Cleared Mar 2002. https://www.510kdatabase.net/k020667/ 2002-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k020667-codman-hakim-shunt-systems-fda-510k.jpg K020667 - CODMAN HAKIM SHUNT SYSTEMS K020667 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Mar 2002. https://www.510kdatabase.net/k020322/ 2002-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k020322-bd-phoenix-automated-microbiology-system-fda-510k.jpg K020322 - BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM K020322 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Mar 2002. https://www.510kdatabase.net/k004022/ 2002-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k004022-m3-mirco-multileaf-collimator-fda-510k.jpg K004022 - M3 (MIRCO-MULTILEAF COLLIMATOR K004022 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab AG. Cleared Mar 2002. https://www.510kdatabase.net/k020159/ 2002-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k020159-smith-nephew-twinfix-ti-quick-t-fda-510k.jpg K020159 - SMITH & NEPHEW TWINFIX TI QUICK T K020159 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Mar 2002. https://www.510kdatabase.net/k020796/ 2002-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k020796-card-iq-analysis-ii-fda-510k.jpg K020796 - CARD IQ ANALYSIS II K020796 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Mar 2002. https://www.510kdatabase.net/k004009/ 2002-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k004009-3m-attest-290-auto-reader-fda-510k.jpg K004009 - 3M ATTEST 290 AUTO-READER K004009 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Mar 2002. https://www.510kdatabase.net/k020870/ 2002-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k020870-vitek-2-antimicrobial-susceptibility-fda-510k.jpg K020870 - VITEK 2 ANTIMICROBIAL SUSCEPTIBILITY TEST SYTEM FOR SPARFLOXACIN K020870 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Mar 2002. https://www.510kdatabase.net/k020580/ 2002-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k020580-x-series-bi-metric-hip-femoral-fda-510k.jpg K020580 - X-SERIES BI-METRIC HIP FEMORAL COMPONENTS K020580 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Mar 2002. https://www.510kdatabase.net/k012915/ 2002-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k012915-dinamap-pro-1000-monitor-model-1000-fda-510k.jpg K012915 - DINAMAP PRO 1000 MONITOR, MODEL 1000 K012915 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Mar 2002. https://www.510kdatabase.net/k014139/ 2002-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k014139-diabetes-assistant-software-fda-510k.jpg K014139 - DIABETES ASSISTANT SOFTWARE K014139 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Mar 2002. https://www.510kdatabase.net/k014197/ 2002-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k014197-synthes-high-tibial-osteotomy-plate-fda-510k.jpg K014197 - SYNTHES HIGH TIBIAL OSTEOTOMY PLATE K014197 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Mar 2002. https://www.510kdatabase.net/k014207/ 2002-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k014207-reposable-instrument-system-models-fda-510k.jpg K014207 - REPOSABLE INSTRUMENT SYSTEM, MODELS MF001-MF083 K014207 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Mar 2002. https://www.510kdatabase.net/k020635/ 2002-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k020635-kodak-directview-cr-800-system-catalog-fda-510k.jpg K020635 - KODAK DIRECTVIEW CR 800 SYSTEM, CATALOG# 1268622 K020635 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Mar 2002. https://www.510kdatabase.net/k012996/ 2002-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k012996-barbiturates-fda-510k.jpg K012996 - BARBITURATES K012996 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Mar 2002. https://www.510kdatabase.net/k013001/ 2002-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k013001-methadone-fda-510k.jpg K013001 - METHADONE K013001 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Mar 2002. https://www.510kdatabase.net/k013100/ 2002-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k013100-propoxyphene-fda-510k.jpg K013100 - PROPOXYPHENE K013100 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Mar 2002. https://www.510kdatabase.net/k020316/ 2002-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k020316-cordis-trapease-permanent-vena-cava-fda-510k.jpg K020316 - CORDIS TRAPEASE PERMANENT VENA CAVA FILTER WITH THE VISEASE ANGIOGRAPHIC VESSEL DILATOR K020316 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Mar 2002. https://www.510kdatabase.net/k020777/ 2002-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k020777-bipap-synchrony-ventilatory-support-fda-510k.jpg K020777 - BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM WITH BI-FLEX K020777 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Mar 2002. https://www.510kdatabase.net/k014172/ 2002-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k014172-nelson-electrosurgical-unit-model-gn640-fda-510k.jpg K014172 - NELSON ELECTROSURGICAL UNIT, MODEL GN640 K014172 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Mar 2002. https://www.510kdatabase.net/k014195/ 2002-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k014195-kayak-hydrophilic-guide-wires-fda-510k.jpg K014195 - KAYAK HYDROPHILIC GUIDE WIRES K014195 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Boston Scientific Corp. Cleared Mar 2002. https://www.510kdatabase.net/k014149/ 2002-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k014149-paediscope-model-p010a-and-pf011a-fda-510k.jpg K014149 - PAEDISCOPE, MODEL # P010A AND PF011A K014149 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Mar 2002. https://www.510kdatabase.net/k014155/ 2002-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k014155-openingclosing-wedge-ostetomy-plates-fda-510k.jpg K014155 - OPENING/CLOSING WEDGE OSTETOMY PLATES K014155 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Mar 2002. https://www.510kdatabase.net/k012778/ 2002-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k012778-vaporized-hydrogen-peroxide-vhp-fda-510k.jpg K012778 - VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE GENESIS KNEE SYSTEM, THE GENESIS II KNEE SYS K012778 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Mar 2002. https://www.510kdatabase.net/k012787/ 2002-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k012787-vaporized-hydrogen-peroxide-vhp-fda-510k.jpg K012787 - VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UHMWPE COMPONENTS IN THE REFLECTION ACTABULAR SYSTEM (ACETABULAR LINE K012787 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Mar 2002. https://www.510kdatabase.net/k012788/ 2002-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k012788-vaporized-hydrogen-peroxide-vhp-fda-510k.jpg K012788 - VAPORIZED HYDROGEN PEROXIDE (VHP) STERILIZATION OF UNMWPE COMPONENTS IN THE COFIELD TOTAL SHOULDER SYSTEM, THE NEER II K012788 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Mar 2002. https://www.510kdatabase.net/k014171/ 2002-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k014171-advance-unicondylar-knee-system-fda-510k.jpg K014171 - ADVANCE UNICONDYLAR KNEE SYSTEM K014171 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Mar 2002. https://www.510kdatabase.net/k014188/ 2002-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k014188-new-prophy-powder-fda-510k.jpg K014188 - NEW PROPHY POWDER K014188 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Mar 2002. https://www.510kdatabase.net/k012448/ 2002-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k012448-vectorvision-trauma-fda-510k.jpg K012448 - VECTORVISION TRAUMA K012448 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Mar 2002. https://www.510kdatabase.net/k020142/ 2002-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k020142-microscan-synergies-plus-fda-510k.jpg K020142 - MICROSCAN SYNERGIES PLUS K020142 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Mar 2002. https://www.510kdatabase.net/k020160/ 2002-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k020160-dried-gram-positive-miccombo-panels-fda-510k.jpg K020160 - DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH AMPICILLIN K020160 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Mar 2002. https://www.510kdatabase.net/k020162/ 2002-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k020162-dried-gram-positive-miccombo-panels-fda-510k.jpg K020162 - DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH PENICILLIN K020162 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Mar 2002. https://www.510kdatabase.net/k020248/ 2002-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k020248-microscan-synergies-plus-gram-negative-fda-510k.jpg K020248 - MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TRIMETHOPRIM/SULFAMETHOXAZOLE (0.25/4.75-64/1216 UG/ML) K020248 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Mar 2002. https://www.510kdatabase.net/k012998/ 2002-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k012998-amphetaminemethamphetamine-fda-510k.jpg K012998 - AMPHETAMINE/METHAMPHETAMINE K012998 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Mar 2002. https://www.510kdatabase.net/k013004/ 2002-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k013004-cocaine-fda-510k.jpg K013004 - COCAINE K013004 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Mar 2002. https://www.510kdatabase.net/k013096/ 2002-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k013096-phencyclidine-fda-510k.jpg K013096 - PHENCYCLIDINE K013096 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Mar 2002. https://www.510kdatabase.net/k013143/ 2002-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k013143-benzodiazepines-fda-510k.jpg K013143 - BENZODIAZEPINES K013143 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Mar 2002. https://www.510kdatabase.net/k013247/ 2002-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k013247-cannabinoids-fda-510k.jpg K013247 - CANNABINOIDS K013247 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Mar 2002. https://www.510kdatabase.net/k013314/ 2002-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k013314-opiates-fda-510k.jpg K013314 - OPIATES K013314 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Mar 2002. https://www.510kdatabase.net/k020573/ 2002-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k020573-modification-to-magnetom-rhapsody-system-fda-510k.jpg K020573 - MODIFICATION TO MAGNETOM RHAPSODY SYSTEM K020573 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2002. https://www.510kdatabase.net/k020480/ 2002-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k020480-rbm-fda-510k.jpg K020480 - RBM K020480 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Mar 2002. https://www.510kdatabase.net/k020485/ 2002-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k020485-all-in-one-two-chamber-container-3200-fda-510k.jpg K020485 - ALL-IN-ONE TWO CHAMBER CONTAINER 3200 ML, 2000 ML & 1000 ML K020485 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 2002. https://www.510kdatabase.net/k014052/ 2002-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k014052-edwards-lifesciences-percutaneous-fda-510k.jpg K014052 - EDWARDS LIFESCIENCES PERCUTANEOUS SHEATH INTRODUCERS WITH OLIGON MATERIAL K014052 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Mar 2002. https://www.510kdatabase.net/k014054/ 2002-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k014054-edwards-lifesciences-swan-ganz-fda-510k.jpg K014054 - EDWARDS LIFESCIENCES SWAN-GANZ MONITORING CATHETER WITH OLIGON MATERIAL K014054 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Mar 2002. https://www.510kdatabase.net/k020438/ 2002-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k020438-sas-value-hcg-fda-510k.jpg K020438 - SAS VALUE HCG K020438 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sa Scientific, Inc.. Cleared Mar 2002. https://www.510kdatabase.net/k012506/ 2002-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k012506-mastergraft-resorbable-ceramic-granules-fda-510k.jpg K012506 - MASTERGRAFT RESORBABLE CERAMIC GRANULES K012506 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Mar 2002. https://www.510kdatabase.net/k020369/ 2002-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k020369-elecsys-anti-tg-calcheck-fda-510k.jpg K020369 - ELECSYS ANTI-TG CALCHECK K020369 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Mar 2002. https://www.510kdatabase.net/k020497/ 2002-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k020497-trident-elevated-rim-liner-fda-510k.jpg K020497 - TRIDENT ELEVATED RIM LINER K020497 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Mar 2002. https://www.510kdatabase.net/k020572/ 2002-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k020572-accolade-tmzf-ha-132-degree-size-0-hip-fda-510k.jpg K020572 - ACCOLADE TMZF HA 132 DEGREE SIZE 0 HIP STEM K020572 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Mar 2002. https://www.510kdatabase.net/k011030/ 2002-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k011030-aesculap-miethke-shunt-system-fda-510k.jpg K011030 - AESCULAP -MIETHKE SHUNT SYSTEM K011030 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Mar 2002. https://www.510kdatabase.net/k020521/ 2002-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k020521-modification-to-vigil-lipid-control-fda-510k.jpg K020521 - MODIFICATION TO VIGIL LIPID CONTROL K020521 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Mar 2002. https://www.510kdatabase.net/k012633/ 2002-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k012633-respironics-heated-humidifier-fda-510k.jpg K012633 - RESPIRONICS HEATED HUMIDIFIER K012633 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Feb 2002. https://www.510kdatabase.net/k012975/ 2002-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k012975-sof-tact-diabetes-management-sysyem-fda-510k.jpg K012975 - SOF-TACT DIABETES MANAGEMENT SYSYEM K012975 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Feb 2002. https://www.510kdatabase.net/k013952/ 2002-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k013952-intuitive-surgical-stero-view-fda-510k.jpg K013952 - INTUITIVE SURGICAL STERO VIEW ENDOSCOPIC SYSTEM K013952 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Feb 2002. https://www.510kdatabase.net/k013963/ 2002-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k013963-model-9210-delivery-catheter-model-9210-fda-510k.jpg K013963 - MODEL 9210 DELIVERY CATHETER, MODEL 9210 K013963 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Feb 2002. https://www.510kdatabase.net/k020131/ 2002-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k020131-venus-universal-light-curing-composite-fda-510k.jpg K020131 - VENUS UNIVERSAL LIGHT CURING COMPOSITE K020131 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Feb 2002. https://www.510kdatabase.net/k020483/ 2002-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k020483-advantage-workstation-41-fda-510k.jpg K020483 - ADVANTAGE WORKSTATION 4.1 K020483 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Feb 2002. https://www.510kdatabase.net/k013990/ 2002-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k013990-lifestitch-suturing-device-fda-510k.jpg K013990 - LIFESTITCH SUTURING DEVICE K013990 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Feb 2002. https://www.510kdatabase.net/k020291/ 2002-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k020291-exactech-model-pmma-femoral-stem-fda-510k.jpg K020291 - EXACTECH, MODEL PMMA FEMORAL STEM CENTRALIZER K020291 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Feb 2002. https://www.510kdatabase.net/k020274/ 2002-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k020274-wmt-modular-ulnar-head-implant-fda-510k.jpg K020274 - WMT MODULAR ULNAR HEAD IMPLANT K020274 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Feb 2002. https://www.510kdatabase.net/k013241/ 2002-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k013241-arndt-emergency-cricothyrotomy-fda-510k.jpg K013241 - ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET K013241 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Cook, Inc.. Cleared Feb 2002. https://www.510kdatabase.net/k013252/ 2002-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k013252-patil-emergency-cricothyrotomy-fda-510k.jpg K013252 - PATIL EMERGENCY CRICOTHYROTOMY CATHETER SET K013252 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Cook, Inc.. Cleared Feb 2002. https://www.510kdatabase.net/k020087/ 2002-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k020087-synthes-cranial-plates-fda-510k.jpg K020087 - SYNTHES CRANIAL PLATES K020087 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Feb 2002. https://www.510kdatabase.net/k020277/ 2002-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k020277-siemens-medical-infromation-bus-mib-ii-fda-510k.jpg K020277 - SIEMENS MEDICAL INFROMATION BUS (MIB II) PROTOCOL CONVERTER K020277 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 2002. https://www.510kdatabase.net/k020328/ 2002-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k020328-microscan-synergies-plus-gram-negative-fda-510k.jpg K020328 - MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEFUROXIME (1-64 UG/ML) K020328 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Feb 2002. https://www.510kdatabase.net/k014173/ 2002-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k014173-synchron-systems-salicylate-reagent-fda-510k.jpg K014173 - SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR K014173 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Feb 2002. https://www.510kdatabase.net/k020144/ 2002-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k020144-siemens-infinity-sc-6002xl-modifications-fda-510k.jpg K020144 - SIEMENS INFINITY SC 6002XL MODIFICATIONS K020144 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 2002. https://www.510kdatabase.net/k020385/ 2002-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k020385-cgs-30a-multislice-upgrade-kit-for-fda-510k.jpg K020385 - CGS-30A MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER, MODEL TSX-101A K020385 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Feb 2002. https://www.510kdatabase.net/k020293/ 2002-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k020293-osteonics-spinal-system-fda-510k.jpg K020293 - OSTEONICS SPINAL SYSTEM K020293 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Feb 2002. https://www.510kdatabase.net/k020052/ 2002-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k020052-smart-nitinol-stent-transhepatic-fda-510k.jpg K020052 - SMART NITINOL STENT TRANSHEPATIC BILIARY SYSTEM K020052 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Feb 2002. https://www.510kdatabase.net/k020283/ 2002-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k020283-back-up-meier-steerable-guidewire-fda-510k.jpg K020283 - BACK-UP MEIER STEERABLE GUIDEWIRE K020283 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Feb 2002. https://www.510kdatabase.net/k012938/ 2002-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k012938-smith-nephew-image-guided-surgical-fda-510k.jpg K012938 - SMITH & NEPHEW IMAGE GUIDED SURGICAL INSTRUMENTS FOR KNEE APPLICATIONS K012938 is a FDA 510(k) cleared neurology medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Feb 2002. https://www.510kdatabase.net/k013806/ 2002-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k013806-synthes-metallic-spiked-washers-fda-510k.jpg K013806 - SYNTHES METALLIC SPIKED WASHERS K013806 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Feb 2002. https://www.510kdatabase.net/k014015/ 2002-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k014015-olympus-hdl-cholesterol-reagent-fda-510k.jpg K014015 - OLYMPUS HDL CHOLESTEROL REAGENT K014015 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus America, Inc.. Cleared Feb 2002. https://www.510kdatabase.net/k014032/ 2002-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k014032-olympus-ldl-cholesterol-reagent-fda-510k.jpg K014032 - OLYMPUS LDL CHOLESTEROL REAGENT, OLYMPUS LDL CHOLESTEROL CALIBRATOR, OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA K014032 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus America, Inc.. Cleared Feb 2002. https://www.510kdatabase.net/k012589/ 2002-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k012589-fast-set-putty-fda-510k.jpg K012589 - FAST SET PUTTY K012589 is a FDA 510(k) cleared neurology medical device. Manufacturer: Synthes (Usa). Cleared Feb 2002. https://www.510kdatabase.net/k011540/ 2002-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k011540-viewpoint-central-monitoring-system-fda-510k.jpg K011540 - VIEWPOINT CENTRAL MONITORING SYSTEM, MODEL 0998-00-0187-07 K011540 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Feb 2002. https://www.510kdatabase.net/k020109/ 2002-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k020109-sigma-diagnostics-accuclot-la-control-fda-510k.jpg K020109 - SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL K020109 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Feb 2002. https://www.510kdatabase.net/k020168/ 2002-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k020168-microscan-synergis-plus-gram-negative-fda-510k.jpg K020168 - MICROSCAN SYNERGIS PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TOBRAMYCIN (0.12-32 UG/ML) K020168 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Feb 2002. https://www.510kdatabase.net/k020173/ 2002-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k020173-microscan-synergies-plus-gram-negative-fda-510k.jpg K020173 - MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TETRACYCLINE (0.12-128 UG/ML) K020173 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Feb 2002. https://www.510kdatabase.net/k020182/ 2002-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k020182-microscan-synergies-plus-gram-negative-fda-510k.jpg K020182 - MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH NETILMICIN (0.12-32 UG/ML) K020182 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Feb 2002. https://www.510kdatabase.net/k020185/ 2002-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k020185-microscan-rapids-plus-gram-negative-fda-510k.jpg K020185 - MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC COMBO PANELS WITH GENTAMICIN (0.12-32 UG/ML) K020185 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Feb 2002. https://www.510kdatabase.net/k020209/ 2002-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k020209-microscan-synergies-plus-gram-negative-fda-510k.jpg K020209 - MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMIKACIN (0.25-128 UG/ML) K020209 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Feb 2002. https://www.510kdatabase.net/k020246/ 2002-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k020246-microscan-synergies-plus-gram-negative-fda-510k.jpg K020246 - MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH IMIPENEM (0.25, 1-32 UG/ML) K020246 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Feb 2002. https://www.510kdatabase.net/k020249/ 2002-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k020249-microscan-plus-gram-negative-miccombo-fda-510k.jpg K020249 - MICROSCAN PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MEROPENEM (0.12-32 UG/ML) K020249 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Feb 2002. https://www.510kdatabase.net/k020263/ 2002-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k020263-logiq-3-fda-510k.jpg K020263 - LOGIQ 3 K020263 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Feb 2002. https://www.510kdatabase.net/k020155/ 2002-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k020155-dyna-lok-classic-spinal-system-fda-510k.jpg K020155 - DYNA-LOK CLASSIC SPINAL SYSTEM K020155 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek. Cleared Feb 2002. https://www.510kdatabase.net/k012314/ 2002-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k012314-dyonics-electroblade-resector-fda-510k.jpg K012314 - DYONICS ELECTROBLADE RESECTOR K012314 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Feb 2002. https://www.510kdatabase.net/k013971/ 2002-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k013971-bd-vacutainer-safety-coagulation-tube-fda-510k.jpg K013971 - BD VACUTAINER SAFETY COAGULATION TUBE K013971 is a FDA 510(k) cleared hematology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Feb 2002. https://www.510kdatabase.net/k020022/ 2002-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k020022-dinamap-pro-series-monitor-models-110-fda-510k.jpg K020022 - DINAMAP PRO SERIES MONITOR, MODELS 110, 210, 310, 410 K020022 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Feb 2002. https://www.510kdatabase.net/k011583/ 2002-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k011583-spiked-washer-fda-510k.jpg K011583 - SPIKED WASHER K011583 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jan 2002. https://www.510kdatabase.net/k012551/ 2002-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k012551-liverpool-radial-head-replacement-device-fda-510k.jpg K012551 - LIVERPOOL RADIAL HEAD REPLACEMENT DEVICE K012551 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jan 2002. https://www.510kdatabase.net/k012554/ 2002-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k012554-remstar-auto-cpap-system-fda-510k.jpg K012554 - REMSTAR AUTO CPAP SYSTEM K012554 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Jan 2002. https://www.510kdatabase.net/k011533/ 2002-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k011533-depuy-femoral-heads-fda-510k.jpg K011533 - DEPUY FEMORAL HEADS K011533 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jan 2002. https://www.510kdatabase.net/k014103/ 2002-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k014103-synchron-systems-direct-ldl-fda-510k.jpg K014103 - SYNCHRON SYSTEMS DIRECT LDL CHLOESTEROL REAGENT AND CALIBRATOR K014103 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jan 2002. https://www.510kdatabase.net/k013392/ 2002-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k013392-cardioblate-surgical-ablation-pen-fda-510k.jpg K013392 - CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C K013392 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jan 2002. https://www.510kdatabase.net/k013610/ 2002-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k013610-perifix-safety-epidural-needles-fda-510k.jpg K013610 - PERIFIX SAFETY EPIDURAL NEEDLES K013610 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Jan 2002. https://www.510kdatabase.net/k014220/ 2002-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k014220-t2-femoral-nail-system-fda-510k.jpg K014220 - T2 FEMORAL NAIL SYSTEM K014220 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jan 2002. https://www.510kdatabase.net/k014226/ 2002-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k014226-unitrax-modular-unipolar-system-fda-510k.jpg K014226 - UNITRAX MODULAR UNIPOLAR SYSTEM K014226 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jan 2002. https://www.510kdatabase.net/k014229/ 2002-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k014229-modification-to-opus-spinal-system-fda-510k.jpg K014229 - MODIFICATION TO OPUS SPINAL SYSTEM K014229 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jan 2002. https://www.510kdatabase.net/k013636/ 2002-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k013636-signa-infinity-mr-system-with-excite-fda-510k.jpg K013636 - SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY K013636 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Jan 2002. https://www.510kdatabase.net/k013858/ 2002-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k013858-infinion-06t-mr-imaging-system-fda-510k.jpg K013858 - INFINION 0.6T MR IMAGING SYSTEM K013858 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Jan 2002. https://www.510kdatabase.net/k013128/ 2002-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k013128-n-latex-lpa-fda-510k.jpg K013128 - N LATEX LP(A) K013128 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Jan 2002. https://www.510kdatabase.net/k013155/ 2002-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k013155-dade-thromboplastin-c-plus-fda-510k.jpg K013155 - DADE THROMBOPLASTIN C PLUS K013155 is a FDA 510(k) cleared hematology medical device. Manufacturer: Dade Behring, Inc.. Cleared Jan 2002. https://www.510kdatabase.net/k013870/ 2002-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k013870-smith-nephew-operative-hysteroscope-fda-510k.jpg K013870 - SMITH & NEPHEW OPERATIVE HYSTEROSCOPE, MODEL 7209208 K013870 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jan 2002. https://www.510kdatabase.net/k014212/ 2002-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k014212-bard-conquest-pta-balloon-dilatation-fda-510k.jpg K014212 - BARD CONQUEST PTA BALLOON DILATATION CATHETER K014212 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 2002. https://www.510kdatabase.net/k014213/ 2002-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k014213-siemens-infinity-gateway-suite-fda-510k.jpg K014213 - SIEMENS INFINITY GATEWAY SUITE K014213 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 2002. https://www.510kdatabase.net/k013838/ 2002-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k013838-ksea-clearvision-lens-irrigation-system-fda-510k.jpg K013838 - KSEA CLEARVISION LENS IRRIGATION SYSTEM K013838 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jan 2002. https://www.510kdatabase.net/k014206/ 2002-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k014206-logiqbook-fda-510k.jpg K014206 - LOGIQBOOK K014206 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jan 2002. https://www.510kdatabase.net/k013978/ 2002-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k013978-synchron-systems-pancreatic-amylase-fda-510k.jpg K013978 - SYNCHRON SYSTEMS PANCREATIC AMYLASE (PAM) REAGENT K013978 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jan 2002. https://www.510kdatabase.net/k013415/ 2002-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k013415-synthes-ankle-arthrodesis-plate-fda-510k.jpg K013415 - SYNTHES ANKLE ARTHRODESIS PLATE K013415 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jan 2002. https://www.510kdatabase.net/k013598/ 2002-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k013598-reuse-claim-for-the-bard-fda-510k.jpg K013598 - REUSE CLAIM FOR THE BARD ELECTROPHYSIOLOGY SURELINK, TEMPLINK, AND TEMPLINK M EXTENSION CABLES K013598 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 2002. https://www.510kdatabase.net/k010033/ 2002-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k010033-light-projector-with-endoscopic-camera-fda-510k.jpg K010033 - LIGHT PROJECTOR WITH ENDOSCOPIC CAMERA, 1 CCD CAMERA HEAD NTSC, 1 CCD CAMERA HEAD PAL, LIGHT PROJECTOR, MODEL 5551.107 K010033 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Jan 2002. https://www.510kdatabase.net/k012075/ 2002-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k012075-immulite-toxoplasma-igm-model-lktm1-fda-510k.jpg K012075 - IMMULITE TOXOPLASMA IGM, MODEL LKTM1 AND LKTM2, IMMULITE 2000 TOXOPLASMA IGM, MODEL L2KTM2 AND L2KTM6 K012075 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jan 2002. https://www.510kdatabase.net/k012077/ 2002-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k012077-immulite-rubella-igmlkrm1-lkrm2-fda-510k.jpg K012077 - IMMULITE RUBELLA IGM,LKRM1, LKRM2, IMMULITE 2000 RUBELLA IGM, MODEL L2KRM2, L2KRM6 K012077 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jan 2002. https://www.510kdatabase.net/k013078/ 2002-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k013078-actalyke-mini-activated-clotting-time-fda-510k.jpg K013078 - ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752 K013078 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Jan 2002. https://www.510kdatabase.net/k013416/ 2002-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k013416-intuitive-surgical-endowrist-fda-510k.jpg K013416 - INTUITIVE SURGICAL ENDOWRIST ENDOSCOPIC INSTRUMENT FAMILY K013416 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Jan 2002. https://www.510kdatabase.net/k013515/ 2002-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k013515-infinity-explorer-fda-510k.jpg K013515 - INFINITY EXPLORER K013515 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 2002. https://www.510kdatabase.net/k014097/ 2002-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k014097-ge-logiq-5-fda-510k.jpg K014097 - GE LOGIQ 5 K014097 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Jan 2002. https://www.510kdatabase.net/k013385/ 2002-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k013385-nexgen-complete-knee-solution-rotatng-fda-510k.jpg K013385 - NEXGEN COMPLETE KNEE SOLUTION ROTATNG HINGE KNEE K013385 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jan 2002. https://www.510kdatabase.net/k013648/ 2002-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k013648-viabahn-endoprosthesis-fda-510k.jpg K013648 - VIABAHN ENDOPROSTHESIS K013648 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Jan 2002. https://www.510kdatabase.net/k013671/ 2002-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k013671-l-25-absorbable-surigcal-suture-fda-510k.jpg K013671 - L-25 ABSORBABLE SURIGCAL SUTURE K013671 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Jan 2002. https://www.510kdatabase.net/k013757/ 2002-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k013757-roche-acetaminophen-fda-510k.jpg K013757 - ROCHE ACETAMINOPHEN K013757 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jan 2002. https://www.510kdatabase.net/k013563/ 2001-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k013563-long-trochanteric-nail-system-fda-510k.jpg K013563 - LONG TROCHANTERIC NAIL SYSTEM K013563 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Dec 2001. https://www.510kdatabase.net/k013991/ 2001-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k013991-prolong-highly-crosslinked-fda-510k.jpg K013991 - PROLONG HIGHLY CROSSLINKED POLYETHTYLENE CRUCIATE RETAINING (CR) ARTICULAR SURFACE COMPONENTS K013991 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Dec 2001. https://www.510kdatabase.net/k013549/ 2001-12-26 monthly 0.5 https://www.510kdatabase.net/og-image/k013549-sigma-diagnostics-auto-d-dimer-fda-510k.jpg K013549 - SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971 K013549 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Dec 2001. https://www.510kdatabase.net/k011889/ 2001-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k011889-ultra-thin-sds-balloon-dilatation-fda-510k.jpg K011889 - ULTRA -THIN SDS BALLOON DILATATION CATHETER K011889 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Dec 2001. https://www.510kdatabase.net/k012569/ 2001-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k012569-modification-to-injectable-mimix-fda-510k.jpg K012569 - MODIFICATION TO: INJECTABLE MIMIX K012569 is a FDA 510(k) cleared neurology medical device. Manufacturer: Biomet, Inc.. Cleared Dec 2001. https://www.510kdatabase.net/k013466/ 2001-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k013466-spife-20003000-lipoprotein-fda-510k.jpg K013466 - SPIFE 2000/3000 LIPOPROTEIN K013466 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Dec 2001. https://www.510kdatabase.net/k013482/ 2001-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k013482-abuscreen-online-opiates-300-2000-fda-510k.jpg K013482 - ABUSCREEN ONLINE OPIATES 300 / 2000 K013482 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Dec 2001. https://www.510kdatabase.net/k013527/ 2001-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k013527-modification-to-synthes-usa-reamer-fda-510k.jpg K013527 - MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM K013527 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Dec 2001. https://www.510kdatabase.net/k011139/ 2001-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k011139-lorenz-lactosorb-panels-and-fasteners-fda-510k.jpg K011139 - LORENZ LACTOSORB PANELS AND FASTENERS K011139 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Dec 2001. https://www.510kdatabase.net/k011897/ 2001-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k011897-norian-srs-bone-void-filler-fda-510k.jpg K011897 - NORIAN SRS BONE VOID FILLER K011897 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Dec 2001. https://www.510kdatabase.net/k012323/ 2001-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k012323-bipap-synchrony-ventilatory-support-fda-510k.jpg K012323 - BIPAP SYNCHRONY VENTILATORY SUPPORT SYSTEM K012323 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Dec 2001. https://www.510kdatabase.net/k013475/ 2001-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k013475-trident-porous-titanium-acetabular-fda-510k.jpg K013475 - TRIDENT POROUS TITANIUM ACETABULAR COMPONENT WITH PERI-APATITE COATING K013475 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Dec 2001. https://www.510kdatabase.net/k013916/ 2001-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k013916-melker-emergency-cricothyrotomy-fda-510k.jpg K013916 - MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET K013916 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Cook, Inc.. Cleared Dec 2001. https://www.510kdatabase.net/k013248/ 2001-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k013248-synthes-lcp-distal-tibia-plates-fda-510k.jpg K013248 - SYNTHES LCP DISTAL TIBIA PLATES K013248 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Dec 2001. https://www.510kdatabase.net/k013346/ 2001-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k013346-gore-drapeable-stlt-regenerative-fda-510k.jpg K013346 - GORE DRAPEABLE ST/LT REGENERATIVE MEMBRANE K013346 is a FDA 510(k) cleared dental medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Dec 2001. https://www.510kdatabase.net/k013823/ 2001-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k013823-xia-spinal-system-fda-510k.jpg K013823 - XIA SPINAL SYSTEM K013823 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Dec 2001. https://www.510kdatabase.net/k013860/ 2001-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k013860-auto-suture-surgical-staples-fda-510k.jpg K013860 - AUTO SUTURE SURGICAL STAPLES K013860 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Dec 2001. https://www.510kdatabase.net/k013877/ 2001-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k013877-codman-slim-loc-system-fda-510k.jpg K013877 - CODMAN SLIM-LOC SYSTEM K013877 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Dec 2001. https://www.510kdatabase.net/k013989/ 2001-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k013989-zirconia-ceramic-femoral-head-1214-taper-fda-510k.jpg K013989 - ZIRCONIA CERAMIC FEMORAL HEAD - 12/14 TAPER K013989 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Dec 2001. https://www.510kdatabase.net/k993836/ 2001-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k993836-generation-4-bone-cement-fda-510k.jpg K993836 - GENERATION 4 BONE CEMENT K993836 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Dec 2001. https://www.510kdatabase.net/k014034/ 2001-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k014034-modification-to-synchron-lx-clinical-fda-510k.jpg K014034 - MODIFICATION TO SYNCHRON LX CLINICAL CHEMISTRY SYSTEMS (LX20 AND LX20 PRO) K014034 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Dec 2001. https://www.510kdatabase.net/k013352/ 2001-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k013352-summit-cemented-hip-prosthesis-fda-510k.jpg K013352 - SUMMIT CEMENTED HIP PROSTHESIS K013352 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Dec 2001. https://www.510kdatabase.net/k013430/ 2001-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k013430-ace-bio-win-tibial-nailing-system-fda-510k.jpg K013430 - ACE BIO WIN TIBIAL NAILING SYSTEM K013430 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Dec 2001. https://www.510kdatabase.net/k013282/ 2001-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k013282-gore-introducer-sheath-fda-510k.jpg K013282 - GORE INTRODUCER SHEATH K013282 is a FDA 510(k) cleared immunology medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Dec 2001. https://www.510kdatabase.net/k013538/ 2001-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k013538-ethanol-fda-510k.jpg K013538 - ETHANOL K013538 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Dec 2001. https://www.510kdatabase.net/k012378/ 2001-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k012378-3d-humeral-heads-fda-510k.jpg K012378 - 3D HUMERAL HEADS K012378 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Dec 2001. https://www.510kdatabase.net/k013242/ 2001-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k013242-amsco-harmony-surgical-lighting-and-fda-510k.jpg K013242 - AMSCO HARMONY SURGICAL LIGHTING AND MEDIA SYSTEM K013242 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: STERIS Corporation. Cleared Dec 2001. https://www.510kdatabase.net/k013842/ 2001-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k013842-immuno-trol-low-cells-fda-510k.jpg K013842 - IMMUNO-TROL LOW CELLS K013842 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Dec 2001. https://www.510kdatabase.net/k013076/ 2001-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k013076-synchron-systems-vancomycin-reagent-fda-510k.jpg K013076 - SYNCHRON SYSTEMS VANCOMYCIN REAGENT K013076 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Dec 2001. https://www.510kdatabase.net/k013379/ 2001-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k013379-sas-strepalert-fda-510k.jpg K013379 - SAS STREPALERT K013379 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Dec 2001. https://www.510kdatabase.net/k013066/ 2001-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k013066-hx-56-1-endoscopic-clipping-device-fda-510k.jpg K013066 - HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE K013066 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus America, Inc.. Cleared Dec 2001. https://www.510kdatabase.net/k013890/ 2001-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k013890-surgical-dynamics-meniscal-staple-fda-510k.jpg K013890 - SURGICAL DYNAMICS MENISCAL STAPLE K013890 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Dec 2001. https://www.510kdatabase.net/k011244/ 2001-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k011244-zeus-scientific-inc-athena-multi-lyte-fda-510k.jpg K011244 - ZEUS SCIENTIFIC, INC. ATHENA MULTI-LYTE ANA TEST SYSTEM K011244 is a FDA 510(k) cleared immunology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Dec 2001. https://www.510kdatabase.net/k011451/ 2001-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k011451-reunite-fusion-screw-fda-510k.jpg K011451 - REUNITE FUSION SCREW K011451 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Dec 2001. https://www.510kdatabase.net/k013035/ 2001-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k013035-guardian-limb-salvage-system-fda-510k.jpg K013035 - GUARDIAN LIMB SALVAGE SYSTEM K013035 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Dec 2001. https://www.510kdatabase.net/k013686/ 2001-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k013686-kodak-directview-tabletop-cassette-fda-510k.jpg K013686 - KODAK DIRECTVIEW TABLETOP CASSETTE K013686 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Dec 2001. https://www.510kdatabase.net/k013761/ 2001-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k013761-medline-excel-reclincer-wheelchair-fda-510k.jpg K013761 - MEDLINE EXCEL RECLINCER WHEELCHAIR K013761 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Medline Industries, Inc.. Cleared Dec 2001. https://www.510kdatabase.net/k012324/ 2001-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k012324-accu-chek-active-test-system-fda-510k.jpg K012324 - ACCU-CHEK ACTIVE TEST SYSTEM K012324 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Dec 2001. https://www.510kdatabase.net/k012988/ 2001-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k012988-homechoice-personal-cycler-peritoneal-fda-510k.jpg K012988 - HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469 K012988 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Dec 2001. https://www.510kdatabase.net/k013211/ 2001-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k013211-modification-to-acumatch-l-series-fda-510k.jpg K013211 - MODIFICATION TO: ACUMATCH L-SERIES BIPOLAR ENDOPROSTHESIS K013211 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Dec 2001. https://www.510kdatabase.net/k013658/ 2001-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k013658-modification-to-reflection-cross-fda-510k.jpg K013658 - MODIFICATION TO REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS K013658 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Dec 2001. https://www.510kdatabase.net/k013676/ 2001-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k013676-trident-hemispherical-acetabular-shells-fda-510k.jpg K013676 - TRIDENT HEMISPHERICAL ACETABULAR SHELLS K013676 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Dec 2001. https://www.510kdatabase.net/k013688/ 2001-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k013688-modification-to-xia-spinal-system-fda-510k.jpg K013688 - MODIFICATION TO XIA SPINAL SYSTEM K013688 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Dec 2001. https://www.510kdatabase.net/k012572/ 2001-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k012572-soft-tissue-screw-and-washer-fda-510k.jpg K012572 - SOFT TISSUE SCREW AND WASHER K012572 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Dec 2001. https://www.510kdatabase.net/k012945/ 2001-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k012945-synthes-24-mm-cannulated-screw-fda-510k.jpg K012945 - SYNTHES 2.4 MM CANNULATED SCREW K012945 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Dec 2001. https://www.510kdatabase.net/k013044/ 2001-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k013044-synthes-39-mm-pelvic-screws-fda-510k.jpg K013044 - SYNTHES 3.9 MM PELVIC SCREWS K013044 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Dec 2001. https://www.510kdatabase.net/k011684/ 2001-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k011684-influenza-ab-rapid-test-cat-no-2158-663-fda-510k.jpg K011684 - INFLUENZA A/B RAPID TEST, CAT NO 2158 663 K011684 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Nov 2001. https://www.510kdatabase.net/k012359/ 2001-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k012359-tina-quant-complement-c4-test-system-fda-510k.jpg K012359 - TINA-QUANT COMPLEMENT C4 TEST SYSTEM K012359 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Nov 2001. https://www.510kdatabase.net/k012361/ 2001-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k012361-tina-quant-complement-c3c-test-system-fda-510k.jpg K012361 - TINA-QUANT COMPLEMENT C3C TEST SYSTEM K012361 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Nov 2001. https://www.510kdatabase.net/k011909/ 2001-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k011909-ultra-thin-sds-balloon-dilatation-fda-510k.jpg K011909 - ULTRA-THIN SDS BALLOON DILATATION CATHETER K011909 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Nov 2001. https://www.510kdatabase.net/k013810/ 2001-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k013810-cardiovascular-array-fda-510k.jpg K013810 - CARDIOVASCULAR ARRAY K013810 is a FDA 510(k) cleared radiology medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Nov 2001. https://www.510kdatabase.net/k013711/ 2001-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k013711-bacti-swab-dry-fda-510k.jpg K013711 - BACTI-SWAB DRY K013711 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Nov 2001. https://www.510kdatabase.net/k010579/ 2001-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k010579-stent-support-guide-catheter-fda-510k.jpg K010579 - STENT SUPPORT GUIDE CATHETER K010579 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Nov 2001. https://www.510kdatabase.net/k012854/ 2001-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k012854-renal-guiding-sheath-fda-510k.jpg K012854 - RENAL GUIDING SHEATH K012854 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Nov 2001. https://www.510kdatabase.net/k012875/ 2001-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k012875-signa-openspeed-magnetic-resonance-fda-510k.jpg K012875 - SIGNA OPENSPEED MAGNETIC RESONANCE SYSTEM K012875 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Nov 2001. https://www.510kdatabase.net/k013550/ 2001-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k013550-clirans-e-series-dialyzer-fda-510k.jpg K013550 - CLIRANS E-SERIES DIALYZER K013550 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Terumo Medical Corp.. Cleared Nov 2001. https://www.510kdatabase.net/k013566/ 2001-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k013566-immulite-intact-pth-immulite-2000-fda-510k.jpg K013566 - IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS), LKPP5 (500 TESTS), L2KPP2 (200 TESTS), L2KPP6 K013566 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Nov 2001. https://www.510kdatabase.net/k010601/ 2001-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k010601-fanelli-biliary-stent-fda-510k.jpg K010601 - FANELLI BILIARY STENT K010601 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook, Inc.. Cleared Nov 2001. https://www.510kdatabase.net/k011556/ 2001-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k011556-macs-hma-anterior-spinal-stabilization-fda-510k.jpg K011556 - MACS HMA ANTERIOR SPINAL STABILIZATION SYSTEM K011556 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aesculap, Inc.. Cleared Nov 2001. https://www.510kdatabase.net/k012776/ 2001-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k012776-duracon-constrained-posterior-fda-510k.jpg K012776 - DURACON CONSTRAINED POSTERIOR STABILIZED (PS) TIBIAL INSERT K012776 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Nov 2001. https://www.510kdatabase.net/k012798/ 2001-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k012798-intex-screw-fda-510k.jpg K012798 - INTEX SCREW K012798 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Nov 2001. https://www.510kdatabase.net/k012833/ 2001-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k012833-intuitive-surgical-bipolar-forceps-fda-510k.jpg K012833 - INTUITIVE SURGICAL BIPOLAR FORCEPS K012833 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Nov 2001. https://www.510kdatabase.net/k013206/ 2001-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k013206-tina-quant-apolipoprotein-b-ver2-fda-510k.jpg K013206 - TINA-QUANT APOLIPOPROTEIN B VER.2 K013206 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Nov 2001. https://www.510kdatabase.net/k013249/ 2001-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k013249-tina-quant-apolipoprotein-ver2-fda-510k.jpg K013249 - TINA-QUANT APOLIPOPROTEIN VER.2 K013249 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Nov 2001. https://www.510kdatabase.net/k013468/ 2001-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k013468-long-length-dyax-nail-fda-510k.jpg K013468 - LONG LENGTH DYAX NAIL K013468 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Nov 2001. https://www.510kdatabase.net/k013503/ 2001-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k013503-modification-to-sterile-colles-classic-fda-510k.jpg K013503 - MODIFICATION TO: STERILE COLLES CLASSIC FIXATOR K013503 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Nov 2001. https://www.510kdatabase.net/k011852/ 2001-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k011852-dimension-haic-assay-model-df105-fda-510k.jpg K011852 - DIMENSION HAIC ASSAY, MODEL DF105 K011852 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Nov 2001. https://www.510kdatabase.net/k012752/ 2001-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k012752-wallstent-rx-biliary-endoprostheses-fda-510k.jpg K012752 - WALLSTENT RX BILIARY ENDOPROSTHESES, MODELS 6961-6972 INCLUSIVE K012752 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Nov 2001. https://www.510kdatabase.net/k013278/ 2001-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k013278-tina-quant-apolipoprotein-a-1-ver2-fda-510k.jpg K013278 - TINA-QUANT APOLIPOPROTEIN A-1 VER.2 K013278 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Nov 2001. https://www.510kdatabase.net/k013544/ 2001-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k013544-sigma-diagnostics-auto-d-dimer-control-fda-510k.jpg K013544 - SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096 K013544 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Nov 2001. https://www.510kdatabase.net/k013545/ 2001-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k013545-sigma-diagnostics-auto-d-dimer-control-fda-510k.jpg K013545 - SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221 K013545 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Nov 2001. https://www.510kdatabase.net/k013608/ 2001-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k013608-digital-radiography-system-model-dfp-fda-510k.jpg K013608 - DIGITAL RADIOGRAPHY SYSTEM, MODEL DFP-8000D K013608 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Nov 2001. https://www.510kdatabase.net/k012812/ 2001-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k012812-carotid-guiding-sheath-fda-510k.jpg K012812 - CAROTID GUIDING SHEATH K012812 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Nov 2001. https://www.510kdatabase.net/k013524/ 2001-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k013524-trochanteric-dyax-nail-system-fda-510k.jpg K013524 - TROCHANTERIC DYAX NAIL SYSTEM K013524 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Nov 2001. https://www.510kdatabase.net/k011048/ 2001-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k011048-bsm-bone-substitute-material-fda-510k.jpg K011048 - BSM BONE SUBSTITUTE MATERIAL K011048 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Nov 2001. https://www.510kdatabase.net/k012718/ 2001-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k012718-modification-to-corometrics-model-fda-510k.jpg K012718 - MODIFICATION TO COROMETRICS MODEL 120IS MATERNAL/FETAL MONITORING SYSTEM. K012718 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Nov 2001. https://www.510kdatabase.net/k013207/ 2001-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k013207-tina-quant-apolipoprotein-b-ver2-fda-510k.jpg K013207 - TINA-QUANT APOLIPOPROTEIN B VER.2 K013207 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Nov 2001. https://www.510kdatabase.net/k013633/ 2001-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k013633-ssa-770a-aplio-ultrasound-system-fda-510k.jpg K013633 - SSA-770A, APLIO ULTRASOUND SYSTEM K013633 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Nov 2001. https://www.510kdatabase.net/k013114/ 2001-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k013114-bcs-system-fda-510k.jpg K013114 - BCS SYSTEM K013114 is a FDA 510(k) cleared hematology medical device. Manufacturer: Dade Behring, Inc.. Cleared Nov 2001. https://www.510kdatabase.net/k013126/ 2001-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k013126-n-lpa-standard-sy-fda-510k.jpg K013126 - N LP(A) STANDARD SY K013126 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Nov 2001. https://www.510kdatabase.net/k011812/ 2001-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k011812-spectrum-ventricular-catheter-fda-510k.jpg K011812 - SPECTRUM VENTRICULAR CATHETER K011812 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cook, Inc.. Cleared Nov 2001. https://www.510kdatabase.net/k012720/ 2001-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k012720-tulsa-contra-angles-fda-510k.jpg K012720 - TULSA CONTRA ANGLES K012720 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Nov 2001. https://www.510kdatabase.net/k012724/ 2001-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k012724-smith-nephew-vascular-videoendoscope-fda-510k.jpg K012724 - SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273 K012724 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Nov 2001. https://www.510kdatabase.net/k013561/ 2001-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k013561-lightspeed-40-ct-scanner-system-fda-510k.jpg K013561 - LIGHTSPEED 4.0 CT SCANNER SYSTEM K013561 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Nov 2001. https://www.510kdatabase.net/k013350/ 2001-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k013350-modification-to-depuy-c-stem-system-fda-510k.jpg K013350 - MODIFICATION TO DEPUY C-STEM SYSTEM K013350 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Nov 2001. https://www.510kdatabase.net/k012396/ 2001-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k012396-ontrak-testcard-9-fda-510k.jpg K012396 - ONTRAK TESTCARD 9 K012396 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Nov 2001. https://www.510kdatabase.net/k011985/ 2001-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k011985-smith-nephew-phoenix-50-allograft-fda-510k.jpg K011985 - SMITH & NEPHEW PHOENIX 5.0 ALLOGRAFT ANCHOR KIT K011985 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Nov 2001. https://www.510kdatabase.net/k012591/ 2001-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k012591-advance-unicondylar-knee-system-fda-510k.jpg K012591 - ADVANCE UNICONDYLAR KNEE SYSTEM K012591 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Nov 2001. https://www.510kdatabase.net/k013326/ 2001-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k013326-modification-to-datascope-8fr-fda-510k.jpg K013326 - MODIFICATION TO: DATASCOPE 8FR. POLYIMIDE ALT B IAB, 25CC, 34CC, 40CC, DATASCOPE INSERTION KIT FOR 8 FR, POLYIMIDE ALT B K013326 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Nov 2001. https://www.510kdatabase.net/k013373/ 2001-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k013373-omni-c-analyzer-fda-510k.jpg K013373 - OMNI C ANALYZER K013373 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Nov 2001. https://www.510kdatabase.net/k013481/ 2001-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k013481-dual-energy-and-tissue-equalization-fda-510k.jpg K013481 - DUAL ENERGY AND TISSUE EQUALIZATION SOFTWARE OPTION K013481 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Nov 2001. https://www.510kdatabase.net/k012527/ 2001-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k012527-ksea-sialoendoscopes-and-accessories-fda-510k.jpg K012527 - KSEA SIALOENDOSCOPES AND ACCESSORIES K012527 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Nov 2001. https://www.510kdatabase.net/k012495/ 2001-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k012495-or-table-and-headholdermagnetom-fda-510k.jpg K012495 - OR TABLE AND HEADHOLDER/MAGNETOM HARMONY, SYMPHONY, SONATA SYSTEMS K012495 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 2001. https://www.510kdatabase.net/k013422/ 2001-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k013422-cardiq-function-fda-510k.jpg K013422 - CARDIQ FUNCTION K013422 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Oct 2001. https://www.510kdatabase.net/k010532/ 2001-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k010532-osteoset-bvf-kit-fda-510k.jpg K010532 - OSTEOSET BVF KIT K010532 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Oct 2001. https://www.510kdatabase.net/k012410/ 2001-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k012410-infinity-hba-kit-models-537-a-537-b-fda-510k.jpg K012410 - INFINITY HBA KIT, MODELS 537-A, 537-B K012410 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Oct 2001. https://www.510kdatabase.net/k013250/ 2001-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k013250-gore-tex-vascular-graft-fda-510k.jpg K013250 - GORE-TEX VASCULAR GRAFT K013250 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Oct 2001. https://www.510kdatabase.net/k013381/ 2001-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k013381-advanced-lung-analysis-1-fda-510k.jpg K013381 - ADVANCED LUNG ANALYSIS-1 K013381 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Oct 2001. https://www.510kdatabase.net/k012864/ 2001-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k012864-interject-injection-therapy-needle-fda-510k.jpg K012864 - INTERJECT INJECTION THERAPY NEEDLE, MODELS 1810, 1811, 1815, 1816, 1820, 1821, 1825, 1826, 1830, 1831, 1835, 1836 K012864 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Oct 2001. https://www.510kdatabase.net/k012309/ 2001-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k012309-riwo-system-trays-fda-510k.jpg K012309 - RIWO SYSTEM TRAYS K012309 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Oct 2001. https://www.510kdatabase.net/k012364/ 2001-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k012364-aml-hip-prosthesis-fda-510k.jpg K012364 - AML HIP PROSTHESIS K012364 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Oct 2001. https://www.510kdatabase.net/k013135/ 2001-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k013135-immunlite-2000-allergen-specific-ige-fda-510k.jpg K013135 - IMMUNLITE 2000 ALLERGEN-SPECIFIC IGE AND MIXED ALLERGEN PANELS, MODEL L2KUN6 (600 TESTS) K013135 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Oct 2001. https://www.510kdatabase.net/k013144/ 2001-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k013144-dual-port-wizard-low-profile-fda-510k.jpg K013144 - DUAL PORT WIZARD LOW PROFILE REPLACEMENT GASTROSTOMY DEVICE K013144 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 2001. https://www.510kdatabase.net/k013153/ 2001-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k013153-autotome-rx-model-4515-4516-fda-510k.jpg K013153 - AUTOTOME RX MODEL # 4515, 4516 K013153 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Oct 2001. https://www.510kdatabase.net/k013130/ 2001-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k013130-n-lpa-control-sy-fda-510k.jpg K013130 - N LP(A) CONTROL SY K013130 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Oct 2001. https://www.510kdatabase.net/k012482/ 2001-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k012482-storz-modulith-slk-lithotripter-with-fda-510k.jpg K012482 - STORZ MODULITH SLK LITHOTRIPTER WITH MULTIVIEW OPTION K012482 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Oct 2001. https://www.510kdatabase.net/k012900/ 2001-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k012900-access-unconjugated-estriol-calibrators-fda-510k.jpg K012900 - ACCESS UNCONJUGATED ESTRIOL CALIBRATORS K012900 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Oct 2001. https://www.510kdatabase.net/k013235/ 2001-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k013235-modification-to-synchron-control-fda-510k.jpg K013235 - MODIFICATION TO SYNCHRON CONTROL K013235 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Oct 2001. https://www.510kdatabase.net/k013134/ 2001-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k013134-immulite-2000-allergen-specific-ige-fda-510k.jpg K013134 - IMMULITE 2000 ALLERGEN-SPECIFIC IGE AND SPECIFIC ALLERGENS, MDOEL L2KUN6 (600 TESTS) K013134 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Oct 2001. https://www.510kdatabase.net/k013164/ 2001-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k013164-surshield-safety-winged-blood-fda-510k.jpg K013164 - SURSHIELD SAFETY WINGED BLOOD COLLECTION SET K013164 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terumo Medical Corp.. Cleared Oct 2001. https://www.510kdatabase.net/k012883/ 2001-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k012883-ultraflex-esophageal-stent-system-fda-510k.jpg K012883 - ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM K012883 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Oct 2001. https://www.510kdatabase.net/k010528/ 2001-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k010528-titanium-cement-restrictor-material-peek-fda-510k.jpg K010528 - TITANIUM CEMENT RESTRICTOR MATERIAL PEEK K010528 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Oct 2001. https://www.510kdatabase.net/k010016/ 2001-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k010016-melker-cuffed-emergency-cricothyrotomy-fda-510k.jpg K010016 - MELKER CUFFED EMERGENCY CRICOTHYROTOMY CATHETER K010016 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Cook, Inc.. Cleared Oct 2001. https://www.510kdatabase.net/k012993/ 2001-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k012993-modification-to-precise-nitinol-stent-fda-510k.jpg K012993 - MODIFICATION TO PRECISE NITINOL STENT TRANSHEPATIC BILIARY SYSTEM K012993 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Oct 2001. https://www.510kdatabase.net/k013214/ 2001-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k013214-cerebral-blood-flow-analysis-system-fda-510k.jpg K013214 - CEREBRAL BLOOD FLOW ANALYSIS SYSTEM (CBP), MODEL NUMBER CSCP-001A K013214 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Oct 2001. https://www.510kdatabase.net/k012923/ 2001-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k012923-arthrex-fiberwire-usp-size-5-model-ar-fda-510k.jpg K012923 - ARTHREX FIBERWIRE, USP SIZE 5, MODEL AR-7201 K012923 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Arthrex, Inc.. Cleared Oct 2001. https://www.510kdatabase.net/k012091/ 2001-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k012091-pro-femur-fda-510k.jpg K012091 - PRO-FEMUR K012091 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Oct 2001. https://www.510kdatabase.net/k012986/ 2001-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k012986-bipolar-irrigation-forceps-fda-510k.jpg K012986 - BIPOLAR IRRIGATION FORCEPS K012986 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Oct 2001. https://www.510kdatabase.net/k003322/ 2001-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k003322-codman-bactiseal-catheters-fda-510k.jpg K003322 - CODMAN BACTISEAL CATHETERS K003322 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Oct 2001. https://www.510kdatabase.net/k012114/ 2001-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k012114-synthes-locking-distal-radius-plating-fda-510k.jpg K012114 - SYNTHES LOCKING DISTAL RADIUS PLATING SYSTEM K012114 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Sep 2001. https://www.510kdatabase.net/k012470/ 2001-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k012470-modification-to-n-protein-standard-sl-fda-510k.jpg K012470 - MODIFICATION TO N PROTEIN STANDARD SL K012470 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Sep 2001. https://www.510kdatabase.net/k012723/ 2001-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k012723-plateletworks-fda-510k.jpg K012723 - PLATELETWORKS K012723 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Sep 2001. https://www.510kdatabase.net/k012913/ 2001-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k012913-bard-utaverse-small-vessel-pta-balloon-fda-510k.jpg K012913 - BARD UTAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER K012913 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Sep 2001. https://www.510kdatabase.net/k012934/ 2001-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k012934-cell-dyn-3200-system-with-absolute-and-fda-510k.jpg K012934 - CELL-DYN 3200 SYSTEM WITH ABSOLUTE AND PERCENT RETICULOCYTE K012934 is a FDA 510(k) cleared hematology medical device. Manufacturer: Abbott Laboratories. Cleared Sep 2001. https://www.510kdatabase.net/k012901/ 2001-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k012901-color-monogen-fda-510k.jpg K012901 - COLOR-MONOGEN K012901 is a FDA 510(k) cleared immunology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 2001. https://www.510kdatabase.net/k012397/ 2001-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k012397-urisys-2400-urine-test-strip-fda-510k.jpg K012397 - URISYS 2400 URINE TEST STRIP K012397 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Sep 2001. https://www.510kdatabase.net/k012870/ 2001-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k012870-xia-stainless-steel-system-fda-510k.jpg K012870 - XIA STAINLESS STEEL SYSTEM K012870 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Sep 2001. https://www.510kdatabase.net/k012970/ 2001-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k012970-ge-signa-asset-imaging-option-fda-510k.jpg K012970 - GE SIGNA ASSET IMAGING OPTION K012970 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Sep 2001. https://www.510kdatabase.net/k012098/ 2001-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k012098-preclude-pericardial-membrane-fda-510k.jpg K012098 - PRECLUDE PERICARDIAL MEMBRANE K012098 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Sep 2001. https://www.510kdatabase.net/k011944/ 2001-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k011944-dyonics-vision-635-digital-capture-fda-510k.jpg K011944 - DYONICS VISION 635 DIGITAL CAPTURE SYSTEM, MODEL 7209088 K011944 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Sep 2001. https://www.510kdatabase.net/k011975/ 2001-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k011975-horizon-outlook-with-dosecom-fda-510k.jpg K011975 - HORIZON OUTLOOK WITH DOSECOM K011975 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Sep 2001. https://www.510kdatabase.net/k012201/ 2001-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k012201-premicron-nonabsorbable-pet-surgical-fda-510k.jpg K012201 - PREMICRON NONABSORBABLE PET SURGICAL SUTURE K012201 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Sep 2001. https://www.510kdatabase.net/k012301/ 2001-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k012301-immulite-2000-digoxin-models-l2kdi2-fda-510k.jpg K012301 - IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS) K012301 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Sep 2001. https://www.510kdatabase.net/k012371/ 2001-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k012371-tina-quant-transferrin-ver2-fda-510k.jpg K012371 - TINA-QUANT TRANSFERRIN VER.2 K012371 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Sep 2001. https://www.510kdatabase.net/k012393/ 2001-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k012393-tina-quant-transferrin-ver2-fda-510k.jpg K012393 - TINA-QUANT TRANSFERRIN VER.2 K012393 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Sep 2001. https://www.510kdatabase.net/k012351/ 2001-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k012351-bdprobetec-et-ctgc-amplified-dna-assay-fda-510k.jpg K012351 - BDPROBETEC ET CT/GC AMPLIFIED DNA ASSAY K012351 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Becton, Dickinson & CO. Cleared Sep 2001. https://www.510kdatabase.net/k012722/ 2001-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k012722-lyphochek-coagulation-control-level-1-fda-510k.jpg K012722 - LYPHOCHEK COAGULATION CONTROL LEVEL 1, LYPHOCHEK COAGULATION LEVEL 2, LYPHOCHEK COAGULATION LEVEL 3, MODELS 781,782,783 K012722 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bio-Rad. Cleared Sep 2001. https://www.510kdatabase.net/k012768/ 2001-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k012768-hemosil-recombi-plastin-fda-510k.jpg K012768 - HEMOSIL RECOMBI PLASTIN K012768 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 2001. https://www.510kdatabase.net/k012775/ 2001-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k012775-ge-positracediscovery-vi-petct-dual-fda-510k.jpg K012775 - GE POSITRACE/DISCOVERY VI PET/CT DUAL MODE ONCOLOGY SCANNER K012775 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Sep 2001. https://www.510kdatabase.net/k011911/ 2001-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k011911-suction-pump-for-intracorporeal-fda-510k.jpg K011911 - SUCTION PUMP FOR INTRACORPOREAL ULTRASOUND LITHOTRIPTER AND ACCESSORIES, MODEL 2207.XXX K011911 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Sep 2001. https://www.510kdatabase.net/k011240/ 2001-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k011240-evencare-blood-glucose-monitoring-system-fda-510k.jpg K011240 - EVENCARE BLOOD GLUCOSE MONITORING SYSTEM K011240 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Medline Industries, Inc.. Cleared Sep 2001. https://www.510kdatabase.net/k010602/ 2001-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k010602-vectorvision-hip-fda-510k.jpg K010602 - VECTORVISION HIP K010602 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Sep 2001. https://www.510kdatabase.net/k011857/ 2001-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k011857-synthes-usa-trochanteric-fixation-nail-fda-510k.jpg K011857 - SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SYSTEM K011857 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Sep 2001. https://www.510kdatabase.net/k011918/ 2001-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k011918-nihon-kohden-bsm-2300a-series-bedside-fda-510k.jpg K011918 - NIHON KOHDEN BSM-2300A SERIES BEDSIDE MONITOR AND ACCESSORIES, MODEL BSM-2300A SERIES K011918 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Sep 2001. https://www.510kdatabase.net/k012741/ 2001-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k012741-liquichek-tdm-control-fda-510k.jpg K012741 - LIQUICHEK TDM CONTROL K012741 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Sep 2001. https://www.510kdatabase.net/k012233/ 2001-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k012233-stratus-cs-troponin-i-calibrator-fda-510k.jpg K012233 - STRATUS CS TROPONIN I CALIBRATOR K012233 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Sep 2001. https://www.510kdatabase.net/k012902/ 2001-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k012902-poly-per-q-cath-single-lumen-picc-fda-510k.jpg K012902 - POLY PER-Q-CATH SINGLE LUMEN PICC CATHETER, MODEL 3143100 K012902 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Sep 2001. https://www.510kdatabase.net/k011810/ 2001-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k011810-orthogenesis-lps-proximal-tibial-fda-510k.jpg K011810 - ORTHOGENESIS LPS PROXIMAL TIBIAL REPLACEMENT AND ORTHOGENESIS LPS TIBIAL BEARING K011810 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Sep 2001. https://www.510kdatabase.net/k012208/ 2001-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k012208-access-thyroglobulin-antibody-and-fda-510k.jpg K012208 - ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895 K012208 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Sep 2001. https://www.510kdatabase.net/k012590/ 2001-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k012590-cordis-palmaz-genesis-transhepatic-fda-510k.jpg K012590 - CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON OPTA PRO .035 DELIVERY SYSTEM K012590 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Sep 2001. https://www.510kdatabase.net/k012836/ 2001-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k012836-modification-to-lightspeed-plus-mobile-fda-510k.jpg K012836 - MODIFICATION TO: LIGHTSPEED PLUS MOBILE CT SYSTEM K012836 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Sep 2001. https://www.510kdatabase.net/k010450/ 2001-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k010450-liver-tamponade-balloon-fda-510k.jpg K010450 - LIVER TAMPONADE BALLOON K010450 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cook, Inc.. Cleared Sep 2001. https://www.510kdatabase.net/k010612/ 2001-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k010612-vectorvision-knee-fda-510k.jpg K010612 - VECTORVISION KNEE K010612 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Sep 2001. https://www.510kdatabase.net/k011815/ 2001-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k011815-synthes-lcp-proximal-humerus-plates-fda-510k.jpg K011815 - SYNTHES LCP PROXIMAL HUMERUS PLATES K011815 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Sep 2001. https://www.510kdatabase.net/k012539/ 2001-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k012539-verastep-fda-510k.jpg K012539 - VERASTEP K012539 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Sep 2001. https://www.510kdatabase.net/k012564/ 2001-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k012564-modification-to-vectorvision-frameless-fda-510k.jpg K012564 - MODIFICATION TO: VECTORVISION FRAMELESS BIOPSY SYSTEM K012564 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Sep 2001. https://www.510kdatabase.net/k012568/ 2001-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k012568-ge-vision-nuclear-medicine-workstation-fda-510k.jpg K012568 - GE VISION NUCLEAR MEDICINE WORKSTATION K012568 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Sep 2001. https://www.510kdatabase.net/k012656/ 2001-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k012656-liquichek-cardiac-markers-control-lt-fda-510k.jpg K012656 - LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648 K012656 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Sep 2001. https://www.510kdatabase.net/k012468/ 2001-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k012468-modification-to-nt-protein-control-sl-fda-510k.jpg K012468 - MODIFICATION TO N/T PROTEIN CONTROL SL K012468 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Sep 2001. https://www.510kdatabase.net/k012162/ 2001-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k012162-stryker-plating-system-basic-fragment-fda-510k.jpg K012162 - STRYKER PLATING SYSTEM BASIC FRAGMENT SET K012162 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Aug 2001. https://www.510kdatabase.net/k010968/ 2001-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k010968-vectorvision-ctfluoro-fda-510k.jpg K010968 - VECTORVISION CT/FLUORO K010968 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Aug 2001. https://www.510kdatabase.net/k012341/ 2001-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k012341-translux-energy-fda-510k.jpg K012341 - TRANSLUX ENERGY K012341 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Aug 2001. https://www.510kdatabase.net/k011984/ 2001-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k011984-bd-vacutainer-push-button-blood-fda-510k.jpg K011984 - BD VACUTAINER PUSH BUTTON BLOOD COLECTION SET K011984 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Becton, Dickinson & CO. Cleared Aug 2001. https://www.510kdatabase.net/k012493/ 2001-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k012493-acumatch-c-series-cemented-femoral-fda-510k.jpg K012493 - ACUMATCH C-SERIES CEMENTED FEMORAL COMPONENT, MODEL SIZE 0 K012493 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Aug 2001. https://www.510kdatabase.net/k012513/ 2001-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k012513-liquichek-lipids-control-level-1-fda-510k.jpg K012513 - LIQUICHEK LIPIDS CONTROL LEVEL 1, LIQUICHEK LIPIDS CONTROL LEVEL 2, MODELS 641 AND 642 K012513 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Aug 2001. https://www.510kdatabase.net/k012083/ 2001-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k012083-attain-access-6218-left-heart-delivery-fda-510k.jpg K012083 - ATTAIN ACCESS 6218 LEFT-HEART DELIVERY SYSTEM, MODEL 6218 K012083 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Aug 2001. https://www.510kdatabase.net/k012130/ 2001-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k012130-attain-lds-6216-left-heart-delivery-fda-510k.jpg K012130 - ATTAIN LDS 6216 LEFT-HEART DELIVERY SYSTEM K012130 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Aug 2001. https://www.510kdatabase.net/k012225/ 2001-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k012225-attain-6215-venogram-balloon-catheter-fda-510k.jpg K012225 - ATTAIN 6215 VENOGRAM BALLOON CATHETER K012225 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Aug 2001. https://www.510kdatabase.net/k002328/ 2001-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k002328-sios-interface-for-auto-light-fda-510k.jpg K002328 - SIOS-INTERFACE FOR AUTO LIGHT PROJECTOR, SIOS-INTERFACE FOR 3 CCD ENDOCAM, SIOS-INTERFACE FOR LAPARO CO2 INSUFFLATOR K002328 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Aug 2001. https://www.510kdatabase.net/k010411/ 2001-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k010411-palmaz-genesis-transhepatic-billary-fda-510k.jpg K010411 - PALMAZ GENESIS TRANSHEPATIC BILLARY STENT AND DELIVERY SYSTEM K010411 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Aug 2001. https://www.510kdatabase.net/k011886/ 2001-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k011886-olympus-eu-m60-eus-exera-endoscopic-fda-510k.jpg K011886 - OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CTR, EUS EXERA ULTRASONIC GASTROVIDEOSCOPE OLYMPUS GF TYPE UM 160, K011886 is a FDA 510(k) cleared radiology medical device. Manufacturer: Olympus America, Inc.. Cleared Aug 2001. https://www.510kdatabase.net/k012646/ 2001-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k012646-terumo-30-gauge-hypodermic-needle-fda-510k.jpg K012646 - TERUMO 30 GAUGE HYPODERMIC NEEDLE K012646 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terumo Medical Corp.. Cleared Aug 2001. https://www.510kdatabase.net/k012365/ 2001-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k012365-vaxcel-dialysis-catheter-fda-510k.jpg K012365 - VAXCEL DIALYSIS CATHETER K012365 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Aug 2001. https://www.510kdatabase.net/k012399/ 2001-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k012399-modification-to-elecsys-fsh-ii-calset-fda-510k.jpg K012399 - MODIFICATION TO ELECSYS FSH II CALSET K012399 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Aug 2001. https://www.510kdatabase.net/k012538/ 2001-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k012538-tubing-and-connectors-with-trillium-fda-510k.jpg K012538 - TUBING AND CONNECTORS WITH TRILLIUM BIOPASSIVE SURFACE K012538 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Aug 2001. https://www.510kdatabase.net/k012560/ 2001-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k012560-ge-logiq-a100-mp-model-2272413-fda-510k.jpg K012560 - GE LOGIQ A100 MP, MODEL 2272413 K012560 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Aug 2001. https://www.510kdatabase.net/k010418/ 2001-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k010418-dried-gram-negative-and-gram-positive-fda-510k.jpg K010418 - DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS K010418 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Aug 2001. https://www.510kdatabase.net/k011811/ 2001-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k011811-monarch-inflation-syringe-fda-510k.jpg K011811 - MONARCH INFLATION SYRINGE K011811 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Aug 2001. https://www.510kdatabase.net/k010785/ 2001-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k010785-ksea-dion-gracia-set-fda-510k.jpg K010785 - KSEA DION-GRACIA SET K010785 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Aug 2001. https://www.510kdatabase.net/k010635/ 2001-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k010635-interlok-ha-copeland-resurfacing-heads-fda-510k.jpg K010635 - INTERLOK / HA COPELAND RESURFACING HEADS K010635 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Aug 2001. https://www.510kdatabase.net/k012311/ 2001-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k012311-immulite-2000-gentamicin-models-l2kge2-fda-510k.jpg K012311 - IMMULITE 2000 GENTAMICIN, MODELS L2KGE2 (200 TESTS), L2KGE6 (600 TESTS) K012311 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Aug 2001. https://www.510kdatabase.net/k012312/ 2001-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k012312-immulite-2000-tobramycn-models-l2ktc2-fda-510k.jpg K012312 - IMMULITE 2000 TOBRAMYCN, MODELS L2KTC2 (2002 TESTS), L2KTC6 (600 TESTS) K012312 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Aug 2001. https://www.510kdatabase.net/k012461/ 2001-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k012461-siemens-infinity-mib-ii-duo-protocol-fda-510k.jpg K012461 - SIEMENS INFINITY MIB II DUO PROTOCOL CONVERTER K012461 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 2001. https://www.510kdatabase.net/k012273/ 2001-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k012273-spiral-radius-90-d-sst-system-fda-510k.jpg K012273 - SPIRAL RADIUS 90-D SST SYSTEM K012273 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Aug 2001. https://www.510kdatabase.net/k012348/ 2001-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k012348-maxim-rpg-ps-femoral-component-fda-510k.jpg K012348 - MAXIM RPG PS FEMORAL COMPONENT K012348 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Aug 2001. https://www.510kdatabase.net/k012452/ 2001-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k012452-model-6500-unipolar-temorary-fda-510k.jpg K012452 - MODEL 6500 UNIPOLAR TEMORARY MYOCARDIAL PACING LEAD K012452 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Aug 2001. https://www.510kdatabase.net/k012454/ 2001-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k012454-model-6491-unipolar-pediatric-fda-510k.jpg K012454 - MODEL 6491 UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD K012454 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Aug 2001. https://www.510kdatabase.net/k012458/ 2001-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k012458-model-6492-unipolar-temporary-atrial-fda-510k.jpg K012458 - MODEL 6492 UNIPOLAR TEMPORARY ATRIAL PACING LEAD K012458 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Aug 2001. https://www.510kdatabase.net/k012459/ 2001-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k012459-model-6494-unipolar-temporary-fda-510k.jpg K012459 - MODEL 6494 UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE K012459 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Aug 2001. https://www.510kdatabase.net/k012460/ 2001-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k012460-model-6495-bipolar-temporary-fda-510k.jpg K012460 - MODEL 6495 BIPOLAR TEMPORARY MYOCARDIAL PACING LEAD K012460 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Aug 2001. https://www.510kdatabase.net/k010242/ 2001-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k010242-cook-zilver-biliary-stent-fda-510k.jpg K010242 - COOK ZILVER BILIARY STENT K010242 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook, Inc.. Cleared Aug 2001. https://www.510kdatabase.net/k011878/ 2001-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k011878-emit-r-tox-salicylic-assay-model-fda-510k.jpg K011878 - EMIT (R) TOX SALICYLIC ASSAY, MODEL 7SO19UL, EMIT (R) TOX SALICYLIC ACID CALIBRATORS, MODEL 7S109UL K011878 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Aug 2001. https://www.510kdatabase.net/k011906/ 2001-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k011906-back-up-meier-guidewire-fda-510k.jpg K011906 - BACK-UP MEIER GUIDEWIRE K011906 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Aug 2001. https://www.510kdatabase.net/k011496/ 2001-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k011496-cysto-urethroscopes-e-line-existing-of-fda-510k.jpg K011496 - CYSTO-URETHROSCOPES E-LINE EXISTING OF: SHEATHS, OBTURATORS, INSERTS, ATTCHEMENTS, AND FORCEPS MODEL 8650, 8652, 8660 K011496 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Aug 2001. https://www.510kdatabase.net/k012155/ 2001-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k012155-kodak-radiation-oncology-software-for-fda-510k.jpg K012155 - KODAK RADIATION ONCOLOGY SOFTWARE/ FOR ACR SYSTEMS K012155 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Aug 2001. https://www.510kdatabase.net/k011665/ 2001-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k011665-bct-system-fda-510k.jpg K011665 - BCT SYSTEM K011665 is a FDA 510(k) cleared hematology medical device. Manufacturer: Dade Behring, Inc.. Cleared Aug 2001. https://www.510kdatabase.net/k011978/ 2001-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k011978-synthes-lcp-proximal-tibia-plate-fda-510k.jpg K011978 - SYNTHES LCP PROXIMAL TIBIA PLATE K011978 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Aug 2001. https://www.510kdatabase.net/k012210/ 2001-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k012210-modification-to-accu-chek-inform-meter-fda-510k.jpg K012210 - MODIFICATION TO ACCU-CHEK INFORM METER K012210 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Aug 2001. https://www.510kdatabase.net/k012286/ 2001-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k012286-modification-tocobas-integra-hdl-fda-510k.jpg K012286 - MODIFICATION TO:COBAS INTEGRA HDL-CHOLESTEROL PLUS 2ND GENERATION K012286 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Aug 2001. https://www.510kdatabase.net/k003281/ 2001-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k003281-lactosorb-rapidflap-fda-510k.jpg K003281 - LACTOSORB RAPIDFLAP K003281 is a FDA 510(k) cleared dental medical device. Manufacturer: Biomet, Inc.. Cleared Aug 2001. https://www.510kdatabase.net/k012287/ 2001-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k012287-modification-to-cobas-integra-ldl-fda-510k.jpg K012287 - MODIFICATION TO: COBAS INTEGRA LDL-CHOLESTEROL PLUS 2ND GENERATION K012287 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Aug 2001. https://www.510kdatabase.net/k010345/ 2001-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k010345-ksea-manhes-take-apart-bipolar-fda-510k.jpg K010345 - KSEA MANHES TAKE-APART BIPOLAR COAGULATING FORCEPS K010345 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Aug 2001. https://www.510kdatabase.net/k011102/ 2001-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k011102-anterior-cruciate-ligament-acl-fda-510k.jpg K011102 - ANTERIOR CRUCIATE LIGAMENT (ACL) INSTRUMENT SYSTEM K011102 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aesculap, Inc.. Cleared Aug 2001. https://www.510kdatabase.net/k011443/ 2001-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k011443-threaded-cement-restrictor-cr-titanium-fda-510k.jpg K011443 - THREADED CEMENT RESTRICTOR (CR) TITANIUM K011443 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Aug 2001. https://www.510kdatabase.net/k011447/ 2001-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k011447-in-space-3d-fda-510k.jpg K011447 - IN SPACE 3D K011447 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 2001. https://www.510kdatabase.net/k012200/ 2001-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k012200-15t-infinity-twinspeed-mr-system-fda-510k.jpg K012200 - 1.5T INFINITY TWINSPEED MR SYSTEM K012200 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Aug 2001. https://www.510kdatabase.net/k012257/ 2001-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k012257-emit-ii-plus-monoclonal-fda-510k.jpg K012257 - EMIT II PLUS MONOCLONAL AMPHETAMINE/METHAMPHETAMINE ASSAY MODEL OSR9C229 K012257 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Aug 2001. https://www.510kdatabase.net/k011458/ 2001-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k011458-synthes-straight-wrist-fusion-plate-fda-510k.jpg K011458 - SYNTHES STRAIGHT WRIST FUSION PLATE, 170MM K011458 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Aug 2001. https://www.510kdatabase.net/k003839/ 2001-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k003839-central-venous-catheter-fda-510k.jpg K003839 - CENTRAL VENOUS CATHETER K003839 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Boston Scientific Corp. Cleared Aug 2001. https://www.510kdatabase.net/k010300/ 2001-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k010300-medtronic-model-7495lz-low-impedance-fda-510k.jpg K010300 - MEDTRONIC MODEL 7495LZ LOW IMPEDANCE EXTENSION K010300 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Aug 2001. https://www.510kdatabase.net/k011372/ 2001-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k011372-aesculap-inc-safil-quick-synthetic-fda-510k.jpg K011372 - AESCULAP, INC. SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE K011372 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Aug 2001. https://www.510kdatabase.net/k011495/ 2001-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k011495-arthrex-bio-post-and-washer-fda-510k.jpg K011495 - ARTHREX BIO-POST AND WASHER K011495 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Aug 2001. https://www.510kdatabase.net/k012087/ 2001-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k012087-cordis-palmaz-genesis-transhepatic-fda-510k.jpg K012087 - CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT K012087 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Aug 2001. https://www.510kdatabase.net/k012158/ 2001-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k012158-modification-to-long-length-gamma-nail-fda-510k.jpg K012158 - MODIFICATION TO: LONG LENGTH GAMMA NAIL K012158 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Aug 2001. https://www.510kdatabase.net/k003285/ 2001-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k003285-exac-trac-20-novalis-body-module-fda-510k.jpg K003285 - EXAC TRAC 2.0 (NOVALIS BODY MODULE) K003285 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab AG. Cleared Jul 2001. https://www.510kdatabase.net/k010522/ 2001-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k010522-surevue-urine-hcg-fda-510k.jpg K010522 - SUREVUE URINE HCG K010522 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Jul 2001. https://www.510kdatabase.net/k010541/ 2001-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k010541-prevision-chem-fda-510k.jpg K010541 - PREVISION CHEM K010541 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Jul 2001. https://www.510kdatabase.net/k011489/ 2001-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k011489-summit-duofix-hip-prosthesis-fda-510k.jpg K011489 - SUMMIT DUOFIX HIP PROSTHESIS K011489 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jul 2001. https://www.510kdatabase.net/k011522/ 2001-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k011522-resorbable-bone-pins-fda-510k.jpg K011522 - RESORBABLE BONE PINS K011522 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jul 2001. https://www.510kdatabase.net/k012219/ 2001-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k012219-scalpfix-clip-system-fda-510k.jpg K012219 - SCALPFIX CLIP SYSTEM K012219 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Jul 2001. https://www.510kdatabase.net/k012251/ 2001-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k012251-optetrak-total-knee-system-straight-fda-510k.jpg K012251 - OPTETRAK TOTAL KNEE SYSTEM, STRAIGHT STEM EXTENSIONS - ADDITIONAL SIZES K012251 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Jul 2001. https://www.510kdatabase.net/k011140/ 2001-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k011140-quanta-plex-ena-profile-4-fda-510k.jpg K011140 - QUANTA PLEX ENA PROFILE 4 K011140 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Jul 2001. https://www.510kdatabase.net/k011334/ 2001-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k011334-synthes-curved-reconstruction-plate-fda-510k.jpg K011334 - SYNTHES CURVED RECONSTRUCTION PLATE K011334 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jul 2001. https://www.510kdatabase.net/k011335/ 2001-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k011335-synths-one-third-tubular-dcl-plate-fda-510k.jpg K011335 - SYNTHS ONE-THIRD TUBULAR DCL PLATE K011335 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jul 2001. https://www.510kdatabase.net/k011281/ 2001-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k011281-intuitive-surgical-ultrasonic-shears-fda-510k.jpg K011281 - INTUITIVE SURGICAL ULTRASONIC SHEARS K011281 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Jul 2001. https://www.510kdatabase.net/k011235/ 2001-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k011235-sysmex-automated-coagulation-analyzer-fda-510k.jpg K011235 - SYSMEX AUTOMATED COAGULATION ANALYZER / MODEL # CA-1500 K011235 is a FDA 510(k) cleared hematology medical device. Manufacturer: Dade Behring, Inc.. Cleared Jul 2001. https://www.510kdatabase.net/k012016/ 2001-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k012016-infinity-sc-8000-with-advanced-fda-510k.jpg K012016 - INFINITY SC 8000 WITH ADVANCED COMMUNICATION OPTION II K012016 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 2001. https://www.510kdatabase.net/k012019/ 2001-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k012019-color-buffed-cb-ddh-femoral-stem-fda-510k.jpg K012019 - COLOR BUFFED (CB) DDH FEMORAL STEM K012019 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jul 2001. https://www.510kdatabase.net/k011296/ 2001-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k011296-infinion-enhancement-package-fda-510k.jpg K011296 - INFINION ENHANCEMENT PACKAGE K011296 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Jul 2001. https://www.510kdatabase.net/k011969/ 2001-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k011969-synthes-cervifix-system-fda-510k.jpg K011969 - SYNTHES CERVIFIX SYSTEM K011969 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jul 2001. https://www.510kdatabase.net/k003709/ 2001-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k003709-surgical-dynamics-mesh-cage-system-fda-510k.jpg K003709 - SURGICAL DYNAMICS MESH CAGE SYSTEM K003709 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Jul 2001. https://www.510kdatabase.net/k011455/ 2001-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k011455-biomet-oncology-salvage-system-oss-fda-510k.jpg K011455 - BIOMET ONCOLOGY SALVAGE SYSTEM (OSS) TAPER STACKING ADAPTER K011455 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jul 2001. https://www.510kdatabase.net/k012026/ 2001-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k012026-trident-all-poly-cup-fda-510k.jpg K012026 - TRIDENT ALL POLY CUP K012026 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jul 2001. https://www.510kdatabase.net/k011112/ 2001-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k011112-cyclosporine-calibrator-fda-510k.jpg K011112 - CYCLOSPORINE CALIBRATOR K011112 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Jul 2001. https://www.510kdatabase.net/k011853/ 2001-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k011853-abbott-tumormarker-mcc-lyophilized-fda-510k.jpg K011853 - ABBOTT TUMORMARKER-MCC (LYOPHILIZED), LEVELS 1 AND 2, 2ML NO. 6E21-10 K011853 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Jul 2001. https://www.510kdatabase.net/k011976/ 2001-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k011976-optetrak-total-knee-system-size-01-fda-510k.jpg K011976 - OPTETRAK TOTAL KNEE SYSTEM SIZE 0/1 DELTA (LINE EXTENSION) K011976 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Jul 2001. https://www.510kdatabase.net/k004043/ 2001-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k004043-metal-transcend-articulation-system-fda-510k.jpg K004043 - METAL TRANSCEND ARTICULATION SYSTEM K004043 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jul 2001. https://www.510kdatabase.net/k011515/ 2001-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k011515-medline-grounding-pad-fda-510k.jpg K011515 - MEDLINE GROUNDING PAD K011515 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medline Industries, Inc.. Cleared Jul 2001. https://www.510kdatabase.net/k011948/ 2001-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k011948-hoffman-ii-hybrid-ring-clamp-fda-510k.jpg K011948 - HOFFMAN II HYBRID RING CLAMP K011948 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jul 2001. https://www.510kdatabase.net/k011965/ 2001-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k011965-imager-ii-urology-torque-catheter-fda-510k.jpg K011965 - IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1 K011965 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Jul 2001. https://www.510kdatabase.net/k011395/ 2001-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k011395-medtronic-colvin-galloway-future-fda-510k.jpg K011395 - MEDTRONIC COLVIN-GALLOWAY FUTURE ANNULOPLASTY BAND, MODEL 638B K011395 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jul 2001. https://www.510kdatabase.net/k011560/ 2001-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k011560-trubyte-denture-base-resin-system-fda-510k.jpg K011560 - TRUBYTE DENTURE BASE RESIN SYSTEM K011560 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jul 2001. https://www.510kdatabase.net/k011867/ 2001-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k011867-liquid-assayed-multiqual-control-fda-510k.jpg K011867 - LIQUID ASSAYED MULTIQUAL CONTROL LEVEL1 #981600 K011867 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Jul 2001. https://www.510kdatabase.net/k010748/ 2001-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k010748-synchron-systems-hemoglobin-a1c-reagent-fda-510k.jpg K010748 - SYNCHRON SYSTEMS HEMOGLOBIN A1C REAGENT K010748 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jul 2001. https://www.510kdatabase.net/k011138/ 2001-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k011138-oxford-unicompartmental-knee-femoral-fda-510k.jpg K011138 - OXFORD UNICOMPARTMENTAL KNEE FEMORAL COMPONENT K011138 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jul 2001. https://www.510kdatabase.net/k010871/ 2001-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k010871-tgl-flex-reagent-cartridge-fda-510k.jpg K010871 - TGL FLEX REAGENT CARTRIDGE K010871 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Jul 2001. https://www.510kdatabase.net/k011342/ 2001-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k011342-coulter-lh-750-hematology-analyzer-fda-510k.jpg K011342 - COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632 K011342 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jul 2001. https://www.510kdatabase.net/k011566/ 2001-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k011566-quanta-lite-h-ttg-human-tissue-fda-510k.jpg K011566 - QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA K011566 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Jul 2001. https://www.510kdatabase.net/k011570/ 2001-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k011570-quanta-lite-h-ttg-human-tissue-fda-510k.jpg K011570 - QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGG ELISA K011570 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Jul 2001. https://www.510kdatabase.net/k011864/ 2001-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k011864-trillium-myotherm-xp-cardioplegia-fda-510k.jpg K011864 - TRILLIUM MYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM, MODELS 41, 41-B K011864 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jul 2001. https://www.510kdatabase.net/k011099/ 2001-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k011099-global-fx-porous-coated-humeral-stem-fda-510k.jpg K011099 - GLOBAL FX POROUS-COATED HUMERAL STEM K011099 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jul 2001. https://www.510kdatabase.net/k011130/ 2001-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k011130-premium-fda-510k.jpg K011130 - PREMIUM K011130 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Jul 2001. https://www.510kdatabase.net/k011170/ 2001-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k011170-synthes-27-mm-lc-dcp-35-mm-profile-fda-510k.jpg K011170 - SYNTHES 2.7 MM LC-DCP, 3.5 MM PROFILE K011170 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jul 2001. https://www.510kdatabase.net/k011110/ 2001-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k011110-m2a-acetabular-system-fda-510k.jpg K011110 - M2A ACETABULAR SYSTEM K011110 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jul 2001. https://www.510kdatabase.net/k011505/ 2001-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k011505-immulite-intact-pth-model-lkpp1-100-fda-510k.jpg K011505 - IMMULITE INTACT PTH, MODEL LKPP1 (100 TESTS), LKPP5 (500 TESTS), IMMULITE 2000 INTACT PTH, MODEL L2KPP (200 TESTS), L2K6 K011505 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jul 2001. https://www.510kdatabase.net/k011947/ 2001-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k011947-emit-2000-valproic-acid-assay-model-fda-510k.jpg K011947 - EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL K011947 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jul 2001. https://www.510kdatabase.net/k011375/ 2001-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k011375-aesculap-inc-monosyn-synthetic-fda-510k.jpg K011375 - AESCULAP, INC., MONOSYN SYNTHETIC ABSORBABLE SURGICAL SUTURE K011375 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Jun 2001. https://www.510kdatabase.net/k003759/ 2001-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k003759-aesculap-spiegelberg-brain-pressure-fda-510k.jpg K003759 - AESCULAP SPIEGELBERG BRAIN PRESSURE MONITOR K003759 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Jun 2001. https://www.510kdatabase.net/k010590/ 2001-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k010590-neuropack-micro-model-med-9100a-series-fda-510k.jpg K010590 - NEUROPACK MICRO, MODEL MED-9100A SERIES K010590 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Jun 2001. https://www.510kdatabase.net/k011047/ 2001-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k011047-global-advantage-humeral-stem-with-fda-510k.jpg K011047 - GLOBAL ADVANTAGE HUMERAL STEM WITH POROCOAT K011047 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jun 2001. https://www.510kdatabase.net/k011317/ 2001-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k011317-multirate-infusor-sv-fda-510k.jpg K011317 - MULTIRATE INFUSOR SV K011317 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jun 2001. https://www.510kdatabase.net/k011359/ 2001-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k011359-modification-to-ksea-endotip-system-fda-510k.jpg K011359 - MODIFICATION TO KSEA ENDOTIP SYSTEM K011359 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jun 2001. https://www.510kdatabase.net/k011643/ 2001-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k011643-scorpio-cr-superflex-tibial-insert-fda-510k.jpg K011643 - SCORPIO CR SUPERFLEX TIBIAL INSERT K011643 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jun 2001. https://www.510kdatabase.net/k011714/ 2001-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k011714-bipap-pro-bi-level-system-fda-510k.jpg K011714 - BIPAP PRO BI-LEVEL SYSTEM K011714 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Jun 2001. https://www.510kdatabase.net/k003182/ 2001-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k003182-orthogenesis-lps-system-fda-510k.jpg K003182 - ORTHOGENESIS LPS SYSTEM K003182 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jun 2001. https://www.510kdatabase.net/k010943/ 2001-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k010943-synthes-sternal-fixation-system-fda-510k.jpg K010943 - SYNTHES STERNAL FIXATION SYSTEM K010943 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jun 2001. https://www.510kdatabase.net/k011034/ 2001-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k011034-synthes-usa-medium-external-fixation-fda-510k.jpg K011034 - SYNTHES (USA) MEDIUM EXTERNAL FIXATION SYSTEM K011034 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jun 2001. https://www.510kdatabase.net/k011299/ 2001-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k011299-smith-and-nephew-500mm-absorbable-fda-510k.jpg K011299 - SMITH AND NEPHEW 5.00MM ABSORBABLE POLYMER ANCHOR K011299 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jun 2001. https://www.510kdatabase.net/k010938/ 2001-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k010938-syngo-multimodality-workstation-fda-510k.jpg K010938 - SYNGO MULTIMODALITY WORKSTATION K010938 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 2001. https://www.510kdatabase.net/k011554/ 2001-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k011554-lorenz-lactosorb-vocal-medialization-fda-510k.jpg K011554 - LORENZ LACTOSORB VOCAL MEDIALIZATION IMPLANT K011554 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Biomet, Inc.. Cleared Jun 2001. https://www.510kdatabase.net/k011579/ 2001-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k011579-lyphochek-tumor-marker-control-levels-fda-510k.jpg K011579 - LYPHOCHEK TUMOR MARKER CONTROL, LEVELS 1 AND 2, 2ML, MODEL 580 K011579 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Jun 2001. https://www.510kdatabase.net/k011145/ 2001-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k011145-modification-to-reflotron-amylase-cat-fda-510k.jpg K011145 - MODIFICATION TO REFLOTRON AMYLASE, CAT. 1200658 K011145 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jun 2001. https://www.510kdatabase.net/k011226/ 2001-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k011226-calibrator-for-automated-systems-fda-510k.jpg K011226 - CALIBRATOR FOR AUTOMATED SYSTEMS K011226 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jun 2001. https://www.510kdatabase.net/k011424/ 2001-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k011424-il-test-pros-fda-510k.jpg K011424 - IL TEST PROS K011424 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jun 2001. https://www.510kdatabase.net/k011720/ 2001-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k011720-olympus-au5400-clinical-chemistry-fda-510k.jpg K011720 - OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER K011720 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus America, Inc.. Cleared Jun 2001. https://www.510kdatabase.net/k011015/ 2001-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k011015-catheter-repair-kit-with-replacement-fda-510k.jpg K011015 - CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 K011015 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jun 2001. https://www.510kdatabase.net/k011584/ 2001-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k011584-medtronic-spinal-cord-stimulation-and-fda-510k.jpg K011584 - MEDTRONIC SPINAL CORD STIMULATION AND PERIPHERAL NERVE STIMULATION SYSTEMS FOR PAIN RELIEF K011584 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Jun 2001. https://www.510kdatabase.net/k002885/ 2001-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k002885-dade-pfa-100-platelet-function-fda-510k.jpg K002885 - DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100, DADE PFA COLLEGEN/EPINEPHRINE TEST CARTRIDE, DADE PFA COLLEAGEN /ADP K002885 is a FDA 510(k) cleared hematology medical device. Manufacturer: Dade Behring, Inc.. Cleared Jun 2001. https://www.510kdatabase.net/k010874/ 2001-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k010874-6f-mach-1-model-34356-xxx-fda-510k.jpg K010874 - 6F MACH 1, MODEL 34356-XXX K010874 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Jun 2001. https://www.510kdatabase.net/k011738/ 2001-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k011738-accu-chek-active-system-fda-510k.jpg K011738 - ACCU-CHEK ACTIVE SYSTEM K011738 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jun 2001. https://www.510kdatabase.net/k003026/ 2001-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k003026-pfc-sigma-lugged-tibial-tray-fda-510k.jpg K003026 - PFC SIGMA LUGGED TIBIAL TRAY K003026 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jun 2001. https://www.510kdatabase.net/k010987/ 2001-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k010987-ksea-miniature-telescope-and-accessories-fda-510k.jpg K010987 - KSEA MINIATURE TELESCOPE AND ACCESSORIES K010987 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jun 2001. https://www.510kdatabase.net/k011137/ 2001-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k011137-resorbable-hammertoe-pin-fda-510k.jpg K011137 - RESORBABLE HAMMERTOE PIN K011137 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jun 2001. https://www.510kdatabase.net/k011172/ 2001-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k011172-arthrex-bio-transfix-fda-510k.jpg K011172 - ARTHREX BIO-TRANSFIX K011172 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jun 2001. https://www.510kdatabase.net/k010553/ 2001-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k010553-precision-xtra-blood-glucose-test-fda-510k.jpg K010553 - PRECISION XTRA BLOOD GLUCOSE TEST STRIP WITH TRUEMEASURE TECHNOLOGY K010553 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jun 2001. https://www.510kdatabase.net/k003920/ 2001-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k003920-cordis-m3-pta-dilatation-catheter-fda-510k.jpg K003920 - CORDIS M3 PTA DILATATION CATHETER K003920 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Jun 2001. https://www.510kdatabase.net/k010817/ 2001-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k010817-mx8000-v50-ct-system-fda-510k.jpg K010817 - MX8000 V5.0 CT SYSTEM K010817 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Jun 2001. https://www.510kdatabase.net/k011367/ 2001-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k011367-excel-fracture-cemented-hip-stem-fda-510k.jpg K011367 - EXCEL FRACTURE CEMENTED HIP STEM K011367 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jun 2001. https://www.510kdatabase.net/k011622/ 2001-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k011622-osteo-ic-femoral-and-tibial-nails-and-fda-510k.jpg K011622 - OSTEO IC FEMORAL AND TIBIAL NAILS AND OSTEO RETROGRADE/ANTEGRADE FEMORAL NAILS WITH T2 LOCKING SCREWS K011622 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jun 2001. https://www.510kdatabase.net/k011623/ 2001-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k011623-exeter-hip-system-with-v40-taper-fda-510k.jpg K011623 - EXETER HIP SYSTEM WITH V40 TAPER K011623 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jun 2001. https://www.510kdatabase.net/k011035/ 2001-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k011035-dimension-drug-calibrator-model-dc22b-fda-510k.jpg K011035 - DIMENSION DRUG CALIBRATOR, MODEL DC22B K011035 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Jun 2001. https://www.510kdatabase.net/k011200/ 2001-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k011200-gilb-model-8010-fda-510k.jpg K011200 - GILB, MODEL 8010 K011200 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Jun 2001. https://www.510kdatabase.net/k003259/ 2001-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k003259-access-toxo-igm-ii-reagents-for-use-on-fda-510k.jpg K003259 - ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 34470,34475,34479 K003259 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jun 2001. https://www.510kdatabase.net/k011509/ 2001-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k011509-barrett-unicondylar-tibial-bearing-fda-510k.jpg K011509 - BARRETT UNICONDYLAR TIBIAL BEARING K011509 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jun 2001. https://www.510kdatabase.net/k011795/ 2001-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k011795-worland-unicondylar-tibial-bearing-fda-510k.jpg K011795 - WORLAND UNICONDYLAR TIBIAL BEARING K011795 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jun 2001. https://www.510kdatabase.net/k010766/ 2001-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k010766-synthes-usa-large-fragment-locking-fda-510k.jpg K010766 - SYNTHES (USA) LARGE FRAGMENT LOCKING COMPRESSION PLATE (LCP) SYSTEM-T PLATE K010766 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jun 2001. https://www.510kdatabase.net/k010780/ 2001-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k010780-trochanteric-nail-fda-510k.jpg K010780 - TROCHANTERIC NAIL K010780 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jun 2001. https://www.510kdatabase.net/k011007/ 2001-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k011007-tenodesis-screw-55-mm-model-ar-1350-55-fda-510k.jpg K011007 - TENODESIS SCREW, 5.5 MM, MODEL AR-1350-55 K011007 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jun 2001. https://www.510kdatabase.net/k011529/ 2001-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k011529-t2-humeral-nail-system-fda-510k.jpg K011529 - T2 HUMERAL NAIL SYSTEM K011529 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jun 2001. https://www.510kdatabase.net/k010752/ 2001-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k010752-aesculaps-modular-endoscopic-fda-510k.jpg K010752 - AESCULAP'S MODULAR ENDOSCOPIC INSTRUMENTS FOR GYNECOLOGY K010752 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Aesculap, Inc.. Cleared Jun 2001. https://www.510kdatabase.net/k011465/ 2001-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k011465-synchron-cx-pro-clinical-systems-model-fda-510k.jpg K011465 - SYNCHRON CX PRO CLINICAL SYSTEMS, MODEL CX4 PRO, CX5 PRO, CX7 PRO, CX9 PRO K011465 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jun 2001. https://www.510kdatabase.net/k011494/ 2001-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k011494-liquichek-immunology-control-level-fda-510k.jpg K011494 - LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1,2,3,1, ML, LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 3 ML, LIQUICHEK IMMUNOLOGY CONTROL K011494 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Jun 2001. https://www.510kdatabase.net/k011624/ 2001-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k011624-expedio-500d-rf-x-ray-system-fda-510k.jpg K011624 - EXPEDIO 500D R&F X-RAY SYSTEM K011624 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Jun 2001. https://www.510kdatabase.net/k011033/ 2001-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k011033-dimension-lithium-li-flex-reagent-fda-510k.jpg K011033 - DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132 K011033 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Jun 2001. https://www.510kdatabase.net/k003062/ 2001-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k003062-bactec-mgit-960-sir-kits-fda-510k.jpg K003062 - BACTEC MGIT 960 SIR KITS K003062 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jun 2001. https://www.510kdatabase.net/k003596/ 2001-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k003596-smith-nephew-restim-fda-510k.jpg K003596 - SMITH & NEPHEW RESTIM K003596 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jun 2001. https://www.510kdatabase.net/k010083/ 2001-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k010083-trapease-permanent-vena-cava-filter-fda-510k.jpg K010083 - TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT, MODEL 466-P306A K010083 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Jun 2001. https://www.510kdatabase.net/k010953/ 2001-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k010953-cell-dyn-4000-immuno-t-cell-cd348-assay-fda-510k.jpg K010953 - CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY K010953 is a FDA 510(k) cleared hematology medical device. Manufacturer: Abbott Laboratories. Cleared Jun 2001. https://www.510kdatabase.net/k011528/ 2001-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k011528-emit-2000-phenobarbital-assay-model-fda-510k.jpg K011528 - EMIT 2000 PHENOBARBITAL ASSAY, MODEL OSR4D229 K011528 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Jun 2001. https://www.510kdatabase.net/k010429/ 2001-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k010429-accutni-and-accutni-calibrators-on-the-fda-510k.jpg K010429 - ACCUTNI AND ACCUTNI CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEM # 33340, 33345 K010429 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jun 2001. https://www.510kdatabase.net/k010701/ 2001-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k010701-medtronic-sofamor-danek-biphasic-fda-510k.jpg K010701 - MEDTRONIC SOFAMOR DANEK BIPHASIC CALCIUM PHOSPHATE (BCP) BONE VOID FILLER K010701 is a FDA 510(k) cleared dental medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Jun 2001. https://www.510kdatabase.net/k011442/ 2001-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k011442-abbott-plum-ainfusion-pump-model-11971-fda-510k.jpg K011442 - ABBOTT PLUM A+INFUSION PUMP, MODEL 11971 K011442 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Jun 2001. https://www.510kdatabase.net/k010658/ 2001-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k010658-modified-uss-fracture-system-fda-510k.jpg K010658 - MODIFIED USS FRACTURE SYSTEM K010658 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jun 2001. https://www.510kdatabase.net/k010632/ 2001-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k010632-butterfly-plate-function-system-fda-510k.jpg K010632 - BUTTERFLY PLATE FUNCTION SYSTEM K010632 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared May 2001. https://www.510kdatabase.net/k010800/ 2001-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k010800-versyocom-fda-510k.jpg K010800 - VERSYO.COM K010800 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared May 2001. https://www.510kdatabase.net/k010865/ 2001-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k010865-amsco-century-medium-sterilizer-model-fda-510k.jpg K010865 - AMSCO CENTURY MEDIUM STERILIZER, MODEL CENTURY K010865 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared May 2001. https://www.510kdatabase.net/k003788/ 2001-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k003788-synthes-resorable-meshes-and-sheets-fda-510k.jpg K003788 - SYNTHES RESORABLE MESHES AND SHEETS K003788 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared May 2001. https://www.510kdatabase.net/k010773/ 2001-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k010773-breast-biopsy-devicemagnetom-systems-fda-510k.jpg K010773 - BREAST BIOPSY DEVICE/MAGNETOM SYSTEMS K010773 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 2001. https://www.510kdatabase.net/k011002/ 2001-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k011002-intuitive-surgical-da-vinci-surgical-fda-510k.jpg K011002 - INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL ISI 1000 K011002 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared May 2001. https://www.510kdatabase.net/k010597/ 2001-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k010597-synchron-lx-systems-high-sensitivity-c-fda-510k.jpg K010597 - SYNCHRON LX SYSTEMS HIGH SENSITIVITY C-REACTIVE PROTIEN (CRPH) REAGENT K010597 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared May 2001. https://www.510kdatabase.net/k011143/ 2001-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k011143-tina-quant-d-dimer-test-system-fda-510k.jpg K011143 - TINA-QUANT D-DIMER TEST SYSTEM K011143 is a FDA 510(k) cleared hematology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared May 2001. https://www.510kdatabase.net/k010557/ 2001-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k010557-jax-granules-bone-void-filler-fda-510k.jpg K010557 - JAX GRANULES BONE VOID FILLER K010557 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared May 2001. https://www.510kdatabase.net/k010518/ 2001-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k010518-synthes-anterolateral-calcaneal-plate-fda-510k.jpg K010518 - SYNTHES ANTEROLATERAL CALCANEAL PLATE K010518 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared May 2001. https://www.510kdatabase.net/k010525/ 2001-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k010525-arthrex-tenodesis-screw-7mm-8mm-9mm-fda-510k.jpg K010525 - ARTHREX TENODESIS SCREW 7MM, 8MM, 9MM K010525 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared May 2001. https://www.510kdatabase.net/k011237/ 2001-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k011237-lactosorb-plates-meshes-and-panelssheets-fda-510k.jpg K011237 - LACTOSORB PLATES, MESHES, AND PANELS/SHEETS K011237 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared May 2001. https://www.510kdatabase.net/k000733/ 2001-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k000733-quanta-lite-asca-s-cerevisiae-iga-elisa-fda-510k.jpg K000733 - QUANTA LITE ASCA (S. CEREVISIAE) IGA ELISA K000733 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared May 2001. https://www.510kdatabase.net/k003589/ 2001-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k003589-vectorvision-cranial-vectorvision-fda-510k.jpg K003589 - VECTORVISION CRANIAL, VECTORVISION SPINAL, VECTORVISION ENT K003589 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared May 2001. https://www.510kdatabase.net/k010936/ 2001-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k010936-modification-to-seamguard-staple-line-fda-510k.jpg K010936 - MODIFICATION TO SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL K010936 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared May 2001. https://www.510kdatabase.net/k010690/ 2001-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k010690-synthes-titanium-multi-vector-distractor-fda-510k.jpg K010690 - SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR K010690 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared May 2001. https://www.510kdatabase.net/k011188/ 2001-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k011188-ge-logiq-9-model-2188900-x-fda-510k.jpg K011188 - GE LOGIQ 9, MODEL 2188900-X K011188 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared May 2001. https://www.510kdatabase.net/k011219/ 2001-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k011219-ascent-knee-system-fda-510k.jpg K011219 - ASCENT KNEE SYSTEM K011219 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared May 2001. https://www.510kdatabase.net/k011167/ 2001-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k011167-xse-fda-510k.jpg K011167 - XSE K011167 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared May 2001. https://www.510kdatabase.net/k011347/ 2001-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k011347-emit-2000-phenytoin-assay-model-0sr4a229-fda-510k.jpg K011347 - EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229 K011347 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared May 2001. https://www.510kdatabase.net/k011213/ 2001-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k011213-modification-to-synchron-lx-20-fda-510k.jpg K011213 - MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM K011213 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared May 2001. https://www.510kdatabase.net/k011217/ 2001-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k011217-clear-or-braided-contrast-media-fda-510k.jpg K011217 - CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE WITH OR WITHOUT ROTATOR, CATH LAB KIT K011217 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Laboratories. Cleared May 2001. https://www.510kdatabase.net/k011218/ 2001-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k011218-acumatch-l-series-cemented-femoral-fda-510k.jpg K011218 - ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL SIZE 1 K011218 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared May 2001. https://www.510kdatabase.net/k010566/ 2001-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k010566-colleague-volumetric-infusion-pump-fda-510k.jpg K010566 - COLLEAGUE VOLUMETRIC INFUSION PUMP K010566 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared May 2001. https://www.510kdatabase.net/k010457/ 2001-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k010457-arthrex-twistloc-suture-anchor-model-fda-510k.jpg K010457 - ARTHREX TWISTLOC SUTURE ANCHOR, MODEL AR-1924 K010457 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared May 2001. https://www.510kdatabase.net/k010673/ 2001-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k010673-arthrex-fiberwire-model-spu-02nb-3800-fda-510k.jpg K010673 - ARTHREX FIBERWIRE, MODEL SPU-02NB-3800 K010673 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Arthrex, Inc.. Cleared May 2001. https://www.510kdatabase.net/k003400/ 2001-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k003400-crp-hs-test-system-fda-510k.jpg K003400 - CRP HS TEST SYSTEM K003400 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared May 2001. https://www.510kdatabase.net/k010696/ 2001-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k010696-beckman-coulter-dnase-b-calibrator-fda-510k.jpg K010696 - BECKMAN COULTER DNASE B CALIBRATOR K010696 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared May 2001. https://www.510kdatabase.net/k011036/ 2001-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k011036-rd-3008-fda-510k.jpg K011036 - RD-3008 K011036 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared May 2001. https://www.510kdatabase.net/k011065/ 2001-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k011065-intracorporeal-ultrasound-lithotripter-fda-510k.jpg K011065 - INTRACORPOREAL ULTRASOUND LITHOTRIPTER, MODEL 2271.004, ULTRASOUND TRANSDUCER, MODEL 2271.501, ULTRASOUND PROBES (SONO) K011065 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared May 2001. https://www.510kdatabase.net/k002824/ 2001-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k002824-macs-modular-anterior-construct-system-fda-510k.jpg K002824 - MACS MODULAR ANTERIOR CONSTRUCT SYSTEM K002824 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aesculap, Inc.. Cleared May 2001. https://www.510kdatabase.net/k010691/ 2001-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k010691-blood-oxygenation-level-dependent-bold-fda-510k.jpg K010691 - BLOOD OXYGENATION LEVEL DEPENDENT (BOLD) OPTION K010691 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared May 2001. https://www.510kdatabase.net/k011204/ 2001-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k011204-neurofax-models-eeg-1100a-eeg-9100a-fda-510k.jpg K011204 - NEUROFAX, MODELS EEG-1100A, EEG-9100A K011204 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared May 2001. https://www.510kdatabase.net/k010520/ 2001-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k010520-gem-premier-3000-addition-of-glucose-fda-510k.jpg K010520 - GEM PREMIER 3000- ADDITION OF GLUCOSE AND LACTATE AS NEW PARAMETERS K010520 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared May 2001. https://www.510kdatabase.net/k011098/ 2001-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k011098-reveal-plus-insertable-loop-recorder-fda-510k.jpg K011098 - REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM MODEL 9526 IMPLANTABLE RECORDER AND MODEL 6191 PATIENT ACTIVATOR K011098 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared May 2001. https://www.510kdatabase.net/k011136/ 2001-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k011136-apex-fixation-pins-fda-510k.jpg K011136 - APEX FIXATION PINS K011136 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared May 2001. https://www.510kdatabase.net/k010344/ 2001-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k010344-adjustable-large-fixator-system-fda-510k.jpg K010344 - ADJUSTABLE LARGE FIXATOR SYSTEM K010344 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared May 2001. https://www.510kdatabase.net/k010348/ 2001-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k010348-tantalum-beads-radiographic-marker-fda-510k.jpg K010348 - TANTALUM BEADS - RADIOGRAPHIC MARKER K010348 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Biomet, Inc.. Cleared May 2001. https://www.510kdatabase.net/k010499/ 2001-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k010499-synthes-usa-midface-distractor-fda-510k.jpg K010499 - SYNTHES (USA) MIDFACE DISTRACTOR K010499 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared May 2001. https://www.510kdatabase.net/k010321/ 2001-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k010321-modular-foot-system-27-mm-module-fda-510k.jpg K010321 - MODULAR FOOT SYSTEM - 2.7 MM MODULE K010321 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared May 2001. https://www.510kdatabase.net/k010346/ 2001-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k010346-ksea-sawahle-electromechanical-fda-510k.jpg K010346 - KSEA SAWAHLE ELECTROMECHANICAL MORCELLATOR K010346 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared May 2001. https://www.510kdatabase.net/k010975/ 2001-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k010975-eclipse-65-fda-510k.jpg K010975 - ECLIPSE 6.5 K010975 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared May 2001. https://www.510kdatabase.net/k003064/ 2001-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k003064-tina-quant-soluble-transferrin-fda-510k.jpg K003064 - TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315 K003064 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared May 2001. https://www.510kdatabase.net/k010494/ 2001-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k010494-sysmex-automated-coagulation-analyzer-fda-510k.jpg K010494 - SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 K010494 is a FDA 510(k) cleared hematology medical device. Manufacturer: Dade Behring, Inc.. Cleared May 2001. https://www.510kdatabase.net/k011096/ 2001-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k011096-abbott-acclaim-encore-model-12237-fda-510k.jpg K011096 - ABBOTT ACCLAIM ENCORE, MODEL 12237 K011096 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared May 2001. https://www.510kdatabase.net/k010993/ 2001-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k010993-alien-rx-micro-cannula-model-4530-fda-510k.jpg K010993 - ALIEN RX MICRO CANNULA, MODEL 4530 K010993 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Apr 2001. https://www.510kdatabase.net/k003740/ 2001-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k003740-miaspas-minitta-anterior-micro-fda-510k.jpg K003740 - MIASPAS MINITTA ANTERIOR MICRO SURGICAL TRANSTHORACIC APPROACH INSTRUMENTATION K003740 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aesculap, Inc.. Cleared Apr 2001. https://www.510kdatabase.net/k010529/ 2001-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k010529-titanium-cement-restrictor-material-fda-510k.jpg K010529 - TITANIUM CEMENT RESTRICTOR MATERIAL PLDLA K010529 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Apr 2001. https://www.510kdatabase.net/k010722/ 2001-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k010722-prolene-polypropylene-3d-patch-fda-510k.jpg K010722 - PROLENE (POLYPROPYLENE) 3D PATCH, NONABSORBABLE SYNTHETIC SURGICAL MESH K010722 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Apr 2001. https://www.510kdatabase.net/k004010/ 2001-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k004010-accu-chek-compact-system-accu-chek-fda-510k.jpg K004010 - ACCU-CHEK COMPACT SYSTEM, ACCU-CHEK COMPACT TEST STRIPS, ACCU-CHEK COMPACT COMPACT CONTROLS K004010 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Apr 2001. https://www.510kdatabase.net/k010527/ 2001-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k010527-synthes-usa-imf-screws-fda-510k.jpg K010527 - SYNTHES (USA) IMF SCREWS K010527 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Apr 2001. https://www.510kdatabase.net/k010550/ 2001-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k010550-vidas-total-prostate-specific-antigen-fda-510k.jpg K010550 - VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428 K010550 is a FDA 510(k) cleared immunology medical device. Manufacturer: bioMerieux, Inc.. Cleared Apr 2001. https://www.510kdatabase.net/k011081/ 2001-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k011081-acumatch-m-series-extra-small-fda-510k.jpg K011081 - ACUMATCH M-SERIES EXTRA-SMALL METAPHYSEAL SEGMENTS K011081 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Apr 2001. https://www.510kdatabase.net/k003275/ 2001-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k003275-synthes-synmesh-spacer-system-fda-510k.jpg K003275 - SYNTHES SYNMESH SPACER SYSTEM K003275 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Apr 2001. https://www.510kdatabase.net/k010313/ 2001-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k010313-dimension-ctni-flex-reagent-cartridge-fda-510k.jpg K010313 - DIMENSION CTNI FLEX REAGENT CARTRIDGE K010313 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Apr 2001. https://www.510kdatabase.net/k010314/ 2001-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k010314-dimension-ctni-calibrator-fda-510k.jpg K010314 - DIMENSION CTNI CALIBRATOR K010314 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Apr 2001. https://www.510kdatabase.net/k010170/ 2001-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k010170-trident-porous-titanium-acetabular-fda-510k.jpg K010170 - TRIDENT POROUS TITANIUM ACETABULAR COMPONENT K010170 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Apr 2001. https://www.510kdatabase.net/k010810/ 2001-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k010810-depuy-preservation-unicondylar-knee-fda-510k.jpg K010810 - DEPUY PRESERVATION UNICONDYLAR KNEE PROSTHESIS K010810 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Apr 2001. https://www.510kdatabase.net/k010845/ 2001-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k010845-modification-to-osteonics-spinal-system-fda-510k.jpg K010845 - MODIFICATION TO OSTEONICS SPINAL SYSTEM K010845 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Apr 2001. https://www.510kdatabase.net/k010878/ 2001-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k010878-modification-to-immulite-herpes-i-ii-fda-510k.jpg K010878 - MODIFICATION TO IMMULITE HERPES I & II IGG, MODEL L2KHS2 & L2KHS6 K010878 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Apr 2001. https://www.510kdatabase.net/k010115/ 2001-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k010115-reflex-anterior-cervical-plate-system-fda-510k.jpg K010115 - REFLEX ANTERIOR CERVICAL PLATE SYSTEM K010115 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Apr 2001. https://www.510kdatabase.net/k003994/ 2001-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k003994-ksea-unidrive-iiii-plus-and-ent-fda-510k.jpg K003994 - KSEA UNIDRIVE II/II PLUS AND ENT ACCESSORIES K003994 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Apr 2001. https://www.510kdatabase.net/k010379/ 2001-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k010379-il-test-free-protein-s-fda-510k.jpg K010379 - IL TEST FREE PROTEIN S K010379 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Apr 2001. https://www.510kdatabase.net/k010765/ 2001-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k010765-coulter-hmx-analyzer-model-6605523-fda-510k.jpg K010765 - COULTER HMX ANALYZER, MODEL 6605523, COULTER HMX WITH AUTOLOADER, MODEL 6605526 K010765 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Apr 2001. https://www.510kdatabase.net/k010774/ 2001-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k010774-avl-hinge-knee-system-fda-510k.jpg K010774 - AVL HINGE KNEE SYSTEM K010774 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Apr 2001. https://www.510kdatabase.net/k010778/ 2001-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k010778-niagara-slim-cath-fda-510k.jpg K010778 - NIAGARA SLIM-CATH K010778 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 2001. https://www.510kdatabase.net/k010781/ 2001-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k010781-3m-espe-haur-fda-510k.jpg K010781 - 3M ESPE HAUR K010781 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Apr 2001. https://www.510kdatabase.net/k010956/ 2001-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k010956-cobra-12-flex-surgical-probe-model-1593x-fda-510k.jpg K010956 - COBRA 1/2 FLEX SURGICAL PROBE, MODEL 1593X K010956 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Boston Scientific Corp. Cleared Apr 2001. https://www.510kdatabase.net/k010942/ 2001-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k010942-u04-fda-510k.jpg K010942 - U04 K010942 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 2001. https://www.510kdatabase.net/k002997/ 2001-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k002997-fiesta-imaging-option-fda-510k.jpg K002997 - FIESTA IMAGING OPTION K002997 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Apr 2001. https://www.510kdatabase.net/k003463/ 2001-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k003463-socon-spinal-system-fda-510k.jpg K003463 - SOCON SPINAL SYSTEM K003463 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aesculap, Inc.. Cleared Apr 2001. https://www.510kdatabase.net/k010693/ 2001-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k010693-vigil-dnase-b-control-fda-510k.jpg K010693 - VIGIL DNASE B CONTROL K010693 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Apr 2001. https://www.510kdatabase.net/k010757/ 2001-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k010757-lfit-v40-femoral-head-components-fda-510k.jpg K010757 - LFIT V40 FEMORAL HEAD COMPONENTS K010757 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Apr 2001. https://www.510kdatabase.net/k002000/ 2001-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k002000-multifuction-suction-irrigation-system-fda-510k.jpg K002000 - MULTIFUCTION SUCTION IRRIGATION SYSTEM, EXISTING OF SUCTION IRRIGATION HANDLES, SUCTION IRRIGATION TUBES, AND TUBE SETS K002000 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Apr 2001. https://www.510kdatabase.net/k010489/ 2001-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k010489-dyonics-vision-111-mobile-video-unit-fda-510k.jpg K010489 - DYONICS VISION 111 MOBILE VIDEO UNIT K010489 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Apr 2001. https://www.510kdatabase.net/k003494/ 2001-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k003494-mimix-bone-replacement-system-fda-510k.jpg K003494 - MIMIX BONE REPLACEMENT SYSTEM K003494 is a FDA 510(k) cleared dental medical device. Manufacturer: Biomet, Inc.. Cleared Apr 2001. https://www.510kdatabase.net/k003527/ 2001-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k003527-modification-to-synthes-usa-polypin-fda-510k.jpg K003527 - MODIFICATION TO SYNTHES (USA) POLYPIN K003527 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Apr 2001. https://www.510kdatabase.net/k010100/ 2001-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k010100-avon-patello-femoral-joint-prosthesis-fda-510k.jpg K010100 - AVON PATELLO-FEMORAL JOINT PROSTHESIS K010100 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Apr 2001. https://www.510kdatabase.net/k010124/ 2001-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k010124-arthrex-univers-30-shoulder-prosthesis-fda-510k.jpg K010124 - ARTHREX UNIVERS 30 SHOULDER PROSTHESIS K010124 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Apr 2001. https://www.510kdatabase.net/k010171/ 2001-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k010171-duraloc-acetabular-cup-system-36mm-fda-510k.jpg K010171 - DURALOC ACETABULAR CUP SYSTEM, 36MM MARATHON +4 POLYETHYLENE LINER K010171 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Apr 2001. https://www.510kdatabase.net/k010801/ 2001-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k010801-t2-femoral-nail-fda-510k.jpg K010801 - T2 FEMORAL NAIL K010801 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Apr 2001. https://www.510kdatabase.net/k010924/ 2001-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k010924-modification-to-plum-xl-infusion-pump-fda-510k.jpg K010924 - MODIFICATION TO PLUM XL INFUSION PUMP K010924 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Apr 2001. https://www.510kdatabase.net/k010129/ 2001-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k010129-excelart-with-pianissimo-model-mrt-fda-510k.jpg K010129 - EXCELART WITH PIANISSIMO, MODEL MRT-1500/P3 K010129 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Apr 2001. https://www.510kdatabase.net/k010236/ 2001-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k010236-immage-immunochemistry-system-high-fda-510k.jpg K010236 - IMMAGE IMMUNOCHEMISTRY SYSTEM HIGH SENSITIVITY C-REACTIVE PROTEIN (CRPH) REAGENT K010236 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Apr 2001. https://www.510kdatabase.net/k010593/ 2001-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k010593-surevue-serumurine-hcg-model-13050100-fda-510k.jpg K010593 - SUREVUE SERUM/URINE HCG, MODEL 1,30,50,100 TEST KIT K010593 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sa Scientific, Inc.. Cleared Apr 2001. https://www.510kdatabase.net/k010906/ 2001-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k010906-medtronic-stylet-kit-models-6282-6293-fda-510k.jpg K010906 - MEDTRONIC STYLET KIT, MODELS 6282, 6293, AND 6254 K010906 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Apr 2001. https://www.510kdatabase.net/k003417/ 2001-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k003417-mini-fiber-endoscopes-fda-510k.jpg K003417 - MINI FIBER ENDOSCOPES K003417 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Apr 2001. https://www.510kdatabase.net/k010035/ 2001-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k010035-ivs-tunneller-fda-510k.jpg K010035 - IVS TUNNELLER K010035 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Apr 2001. https://www.510kdatabase.net/k003613/ 2001-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k003613-30t-signa-vhi-tr-body-imaging-coil-fda-510k.jpg K003613 - 3.0.T SIGNA VH/I (T/R) BODY IMAGING COIL K003613 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Apr 2001. https://www.510kdatabase.net/k010558/ 2001-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k010558-quanta-lite-gpa-gastric-parietal-cell-fda-510k.jpg K010558 - QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA K010558 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Apr 2001. https://www.510kdatabase.net/k010685/ 2001-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k010685-modification-to-millergalante-precoat-fda-510k.jpg K010685 - MODIFICATION TO MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM (8 MM ARTICULAR SURFACE) K010685 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Apr 2001. https://www.510kdatabase.net/k010652/ 2001-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k010652-sigma-diagnostics-sigma-cal-model-s2936-fda-510k.jpg K010652 - SIGMA DIAGNOSTICS SIGMA-CAL, MODEL S2936 K010652 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Mar 2001. https://www.510kdatabase.net/k010263/ 2001-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k010263-remstar-plus-cpap-system-fda-510k.jpg K010263 - REMSTAR PLUS CPAP SYSTEM K010263 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Mar 2001. https://www.510kdatabase.net/k010567/ 2001-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k010567-optiflow-catheter-5641190-catheter-fda-510k.jpg K010567 - OPTIFLOW CATHETER #5641190 CATHETER ONLY #5643150 CATHETER KIT #5631000 CATHETERLESS TRAY-GENERIC (COMBINED WITH CATHETR K010567 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 2001. https://www.510kdatabase.net/k010588/ 2001-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k010588-elecsysca-15-3-ii-assay-fda-510k.jpg K010588 - ELECSYSCA 15-3 II ASSAY K010588 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Mar 2001. https://www.510kdatabase.net/k003113/ 2001-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k003113-ksea-scb-rui-sco-fda-510k.jpg K003113 - KSEA SCB-RUI SCO K003113 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Mar 2001. https://www.510kdatabase.net/k003723/ 2001-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k003723-3m-littmann-fda-510k.jpg K003723 - 3M LITTMANN K003723 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: 3M Company. Cleared Mar 2001. https://www.510kdatabase.net/k010610/ 2001-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k010610-rapid-exchange-biopsy-cap-and-locking-fda-510k.jpg K010610 - RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527 K010610 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Mar 2001. https://www.510kdatabase.net/k001734/ 2001-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k001734-fogarty-valvulotome-model-700091-fda-510k.jpg K001734 - FOGARTY VALVULOTOME, MODEL 700091 K001734 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Mar 2001. https://www.510kdatabase.net/k002286/ 2001-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k002286-ldob-occlusion-balloon-catheter-fda-510k.jpg K002286 - LDOB OCCLUSION BALLOON CATHETER K002286 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Mar 2001. https://www.510kdatabase.net/k003929/ 2001-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k003929-niroyal-biliary-premounted-stent-system-fda-510k.jpg K003929 - NIROYAL BILIARY PREMOUNTED STENT SYSTEM K003929 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Mar 2001. https://www.510kdatabase.net/k010158/ 2001-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k010158-thrombomax-hs-with-calcium-model-t6540-fda-510k.jpg K010158 - THROMBOMAX-HS WITH CALCIUM, MODEL T6540 K010158 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Mar 2001. https://www.510kdatabase.net/k003553/ 2001-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k003553-09-sodium-chloride-injection-usp-bd-fda-510k.jpg K003553 - 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE K003553 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 2001. https://www.510kdatabase.net/k001581/ 2001-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k001581-lactosorb-50-mm-washer-fda-510k.jpg K001581 - LACTOSORB 5.0 MM WASHER K001581 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Mar 2001. https://www.510kdatabase.net/k010310/ 2001-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k010310-modification-to-trident-all-poly-cup-fda-510k.jpg K010310 - MODIFICATION TO TRIDENT ALL POLY CUP K010310 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Mar 2001. https://www.510kdatabase.net/k010560/ 2001-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k010560-portrait-femoral-component-fda-510k.jpg K010560 - PORTRAIT FEMORAL COMPONENT K010560 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Mar 2001. https://www.510kdatabase.net/k010640/ 2001-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k010640-siemens-medical-information-bus-mib-ii-fda-510k.jpg K010640 - SIEMENS MEDICAL INFORMATION BUS (MIB II) PROTOCOL CONVERTER K010640 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2001. https://www.510kdatabase.net/k003747/ 2001-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k003747-c1-inhibitor-microtiter-assay-device-fda-510k.jpg K003747 - C1-INHIBITOR MICROTITER ASSAY DEVICE K003747 is a FDA 510(k) cleared immunology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 2001. https://www.510kdatabase.net/k003846/ 2001-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k003846-accu-chek-inform-meter-fda-510k.jpg K003846 - ACCU-CHEK INFORM METER K003846 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Mar 2001. https://www.510kdatabase.net/k003910/ 2001-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k003910-nexgen-complete-knee-solution-cross-fda-510k.jpg K003910 - NEXGEN COMPLETE KNEE SOLUTION CROSS-LINKED POLYETHYLENE CRUCIATE RETAINING (CR) ARTICULAR SURFACE COMPONENTS K003910 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Mar 2001. https://www.510kdatabase.net/k010052/ 2001-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k010052-respironics-bilichek-non-invasive-100-fda-510k.jpg K010052 - RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20 K010052 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Respironics, Inc.. Cleared Mar 2001. https://www.510kdatabase.net/k002254/ 2001-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k002254-cook-pressure-monitoring-catheter-fda-510k.jpg K002254 - COOK PRESSURE MONITORING CATHETER K002254 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Mar 2001. https://www.510kdatabase.net/k002706/ 2001-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k002706-roche-diagnostics-tina-quant-d-dimer-fda-510k.jpg K002706 - ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA K002706 is a FDA 510(k) cleared hematology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Mar 2001. https://www.510kdatabase.net/k003965/ 2001-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k003965-mri-safe-instruments-fda-510k.jpg K003965 - MRI SAFE INSTRUMENTS K003965 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Mar 2001. https://www.510kdatabase.net/k010206/ 2001-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k010206-dimension-enzymatic-carbonate-eco2-fda-510k.jpg K010206 - DIMENSION ENZYMATIC CARBONATE (ECO2) FLEX METHOD, CATALOG DF137 K010206 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Mar 2001. https://www.510kdatabase.net/k010445/ 2001-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k010445-precise-nitinol-stent-transhepatic-fda-510k.jpg K010445 - PRECISE NITINOL STENT TRANSHEPATIC BILLARY SYSTEM K010445 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Mar 2001. https://www.510kdatabase.net/k003267/ 2001-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k003267-sigma-diagnostics-auto-d-dimer-model-fda-510k.jpg K003267 - SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A K003267 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Mar 2001. https://www.510kdatabase.net/k003501/ 2001-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k003501-n-protein-standard-uy-calibrator-fda-510k.jpg K003501 - N PROTEIN STANDARD UY CALIBRATOR K003501 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Mar 2001. https://www.510kdatabase.net/k010103/ 2001-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k010103-surshield-winged-infusion-set-fda-510k.jpg K010103 - SURSHIELD WINGED INFUSION SET K010103 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terumo Medical Corp.. Cleared Mar 2001. https://www.510kdatabase.net/k010617/ 2001-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k010617-spife-ife-calibrator-and-control-kit-fda-510k.jpg K010617 - SPIFE IFE CALIBRATOR AND CONTROL KIT K010617 is a FDA 510(k) cleared immunology medical device. Manufacturer: Helena Laboratories. Cleared Mar 2001. https://www.510kdatabase.net/k010631/ 2001-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k010631-nemio-fda-510k.jpg K010631 - NEMIO K010631 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Mar 2001. https://www.510kdatabase.net/k010061/ 2001-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k010061-dimension-clinical-chemistry-system-fda-510k.jpg K010061 - DIMENSION CLINICAL CHEMISTRY SYSTEM, MODEL XPAND K010061 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Mar 2001. https://www.510kdatabase.net/k003503/ 2001-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k003503-n-latex-cystatin-c-fda-510k.jpg K003503 - N LATEX CYSTATIN C K003503 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Mar 2001. https://www.510kdatabase.net/k003947/ 2001-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k003947-functional-brain-mapping-option-for-mri-fda-510k.jpg K003947 - FUNCTIONAL BRAIN MAPPING OPTION FOR MRI K003947 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Mar 2001. https://www.510kdatabase.net/k010428/ 2001-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k010428-accutni-qc-on-the-access-immunoassay-fda-510k.jpg K010428 - ACCUTNI QC ON THE ACCESS IMMUNOASSAY SYSTEM #33349 K010428 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Mar 2001. https://www.510kdatabase.net/k010434/ 2001-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k010434-optetrak-b-series-total-knee-system-fda-510k.jpg K010434 - OPTETRAK B-SERIES TOTAL KNEE SYSTEM K010434 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Mar 2001. https://www.510kdatabase.net/k003816/ 2001-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k003816-arthrex-titanium-corkscrew-35-mm-fda-510k.jpg K003816 - ARTHREX TITANIUM CORKSCREW, 3.5 MM, ARTHREX TITANIUM CORKSCREW, 5.0 MM, ARTHREX TITANIUM CORKSCREW 6.5MM K003816 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Mar 2001. https://www.510kdatabase.net/k010367/ 2001-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k010367-modification-to-titanium-tri-lock-hips-fda-510k.jpg K010367 - MODIFICATION TO TITANIUM TRI-LOCK HIPS STEM K010367 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Mar 2001. https://www.510kdatabase.net/k002274/ 2001-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k002274-smith-nephew-suture-hapla-interference-fda-510k.jpg K002274 - SMITH & NEPHEW SUTURE HAPLA INTERFERENCE SCREW K002274 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Mar 2001. https://www.510kdatabase.net/k003550/ 2001-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k003550-infinity-etco2-respiratory-mechanics-pod-fda-510k.jpg K003550 - INFINITY ETCO2 + RESPIRATORY MECHANICS POD K003550 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 2001. https://www.510kdatabase.net/k010362/ 2001-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k010362-accu-chek-comfort-curve-test-strip-fda-510k.jpg K010362 - ACCU-CHEK COMFORT CURVE TEST STRIP K010362 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Mar 2001. https://www.510kdatabase.net/k010358/ 2001-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k010358-vigil-serology-control-level-c-fda-510k.jpg K010358 - VIGIL SEROLOGY CONTROL LEVEL C K010358 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Mar 2001. https://www.510kdatabase.net/k000180/ 2001-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k000180-transanal-endoscopic-microsurgery-tem-fda-510k.jpg K000180 - TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) COMBINATION SYSTEM AND INSTRUMENT SET, INSTRUMENT SET FOR THE TRANSANAL ENDOSCOP K000180 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Mar 2001. https://www.510kdatabase.net/k002489/ 2001-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k002489-intuitive-surgical-da-vinci-endoscopic-fda-510k.jpg K002489 - INTUITIVE SURGICAL DA VINCI ENDOSCOPIC CONTROL SYSTEM K002489 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Mar 2001. https://www.510kdatabase.net/k003328/ 2001-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k003328-accuclot-control-i-model-a4089-fda-510k.jpg K003328 - ACCUCLOT CONTROL I, MODEL A4089 K003328 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Mar 2001. https://www.510kdatabase.net/k003329/ 2001-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k003329-sigma-dianostics-auto-d-dimer-control-fda-510k.jpg K003329 - SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217 K003329 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Mar 2001. https://www.510kdatabase.net/k003362/ 2001-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k003362-astronomerwith-sld-fda-510k.jpg K003362 - ASTRONOMER+WITH SLD K003362 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Mar 2001. https://www.510kdatabase.net/k003411/ 2001-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k003411-elecsys-testosterone-calset-ii-fda-510k.jpg K003411 - ELECSYS TESTOSTERONE CALSET II K003411 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Mar 2001. https://www.510kdatabase.net/k003875/ 2001-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k003875-ti-replica-hip-stem-fda-510k.jpg K003875 - TI-REPLICA HIP STEM K003875 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Mar 2001. https://www.510kdatabase.net/k010329/ 2001-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k010329-logiq-500-fda-510k.jpg K010329 - LOGIQ 500 K010329 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Mar 2001. https://www.510kdatabase.net/k003865/ 2001-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k003865-cobas-integra-amphetamines-fda-510k.jpg K003865 - COBAS INTEGRA AMPHETAMINES K003865 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Feb 2001. https://www.510kdatabase.net/k003963/ 2001-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k003963-dimension-psa-flex-reagent-cartridge-fda-510k.jpg K003963 - DIMENSION PSA FLEX REAGENT CARTRIDGE K003963 is a FDA 510(k) cleared immunology medical device. Manufacturer: Dade Behring, Inc.. Cleared Feb 2001. https://www.510kdatabase.net/k010444/ 2001-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k010444-advantage-single-use-electrosurgical-fda-510k.jpg K010444 - ADVANTAGE SINGLE-USE ELECTROSURGICAL ATTACHMENT-J-HOOK TIP, L-HOOK TIP, CORBITT SPATULA TIP, BALL TIP, NEEDLE TIP K010444 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Feb 2001. https://www.510kdatabase.net/k001744/ 2001-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k001744-olympus-endoscopic-ligation-device-fda-510k.jpg K001744 - OLYMPUS ENDOSCOPIC LIGATION DEVICE K001744 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus America, Inc.. Cleared Feb 2001. https://www.510kdatabase.net/k003786/ 2001-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k003786-smf-resorbable-meshes-and-sheets-fda-510k.jpg K003786 - SMF RESORBABLE MESHES AND SHEETS K003786 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Feb 2001. https://www.510kdatabase.net/k003946/ 2001-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k003946-signa-sp-05t-rotating-horizontal-body-fda-510k.jpg K003946 - SIGNA SP 0.5T ROTATING HORIZONTAL BODY COIL K003946 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Feb 2001. https://www.510kdatabase.net/k003268/ 2001-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k003268-z-touch-fda-510k.jpg K003268 - Z-TOUCH K003268 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Feb 2001. https://www.510kdatabase.net/k010228/ 2001-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k010228-gore-tex-dualmesh-plus-biomaterial-fda-510k.jpg K010228 - GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES K010228 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Feb 2001. https://www.510kdatabase.net/k003608/ 2001-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k003608-sovereign-bipolar-instruments-for-fda-510k.jpg K003608 - SOVEREIGN BIPOLAR INSTRUMENTS FOR GYNECOLOGY K003608 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Aesculap, Inc.. Cleared Feb 2001. https://www.510kdatabase.net/k003612/ 2001-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k003612-microspeed-ec-motorsystem-gd650gd653-fda-510k.jpg K003612 - MICROSPEED EC MOTORSYSTEM GD650/GD653 K003612 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Feb 2001. https://www.510kdatabase.net/k003700/ 2001-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k003700-synthes-hamstring-loop-fda-510k.jpg K003700 - SYNTHES HAMSTRING LOOP K003700 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Feb 2001. https://www.510kdatabase.net/k003870/ 2001-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k003870-thromborel-s-fda-510k.jpg K003870 - THROMBOREL S K003870 is a FDA 510(k) cleared hematology medical device. Manufacturer: Dade Behring, Inc.. Cleared Feb 2001. https://www.510kdatabase.net/k010208/ 2001-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k010208-dimension-enzymatic-carbonate-eco2-fda-510k.jpg K010208 - DIMENSION ENZYMATIC CARBONATE (ECO2) CALIBRATOR, CATALOG DC137 K010208 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Feb 2001. https://www.510kdatabase.net/k003755/ 2001-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k003755-medline-blockade-or-resistat-surgical-fda-510k.jpg K003755 - MEDLINE BLOCKADE OR RESISTAT SURGICAL GOWNS AND SURGGICAL DRAPES K003755 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Feb 2001. https://www.510kdatabase.net/k001147/ 2001-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k001147-enhanced-polyethylene-knee-prostheses-fda-510k.jpg K001147 - ENHANCED POLYETHYLENE KNEE PROSTHESES K001147 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Feb 2001. https://www.510kdatabase.net/k003549/ 2001-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k003549-codman-craniosorb-absorbable-fixation-fda-510k.jpg K003549 - CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM PURPLE RIVETS K003549 is a FDA 510(k) cleared dental medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Feb 2001. https://www.510kdatabase.net/k003572/ 2001-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k003572-dyonics-control-rf-system-fda-510k.jpg K003572 - DYONICS CONTROL RF SYSTEM K003572 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Feb 2001. https://www.510kdatabase.net/k003599/ 2001-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k003599-smith-nephew-suture-anchor-fda-510k.jpg K003599 - SMITH & NEPHEW SUTURE ANCHOR K003599 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Feb 2001. https://www.510kdatabase.net/k004032/ 2001-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k004032-perfecta-and-extend-fda-510k.jpg K004032 - PERFECTA AND EXTEND K004032 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Feb 2001. https://www.510kdatabase.net/k002210/ 2001-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k002210-syntra-dialyzer-model-syntra-120-160-fda-510k.jpg K002210 - SYNTRA DIALYZER, MODEL SYNTRA 120, 160 K002210 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Feb 2001. https://www.510kdatabase.net/k003419/ 2001-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k003419-rcrp-flex-reagent-cartridge-fda-510k.jpg K003419 - RCRP FLEX REAGENT CARTRIDGE K003419 is a FDA 510(k) cleared immunology medical device. Manufacturer: Dade Behring, Inc.. Cleared Feb 2001. https://www.510kdatabase.net/k003566/ 2001-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k003566-cofield-eccentric-and-lateral-offset-fda-510k.jpg K003566 - COFIELD ECCENTRIC AND LATERAL OFFSET HUMERAL HEADS K003566 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Feb 2001. https://www.510kdatabase.net/k003667/ 2001-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k003667-reveal-plus-insertable-loop-recorder-fda-510k.jpg K003667 - REVEAL PLUS INSERTABLE LOOP RECORDER K003667 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Feb 2001. https://www.510kdatabase.net/k003782/ 2001-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k003782-constellation-catheter-model-8031-fda-510k.jpg K003782 - CONSTELLATION CATHETER, MODEL 8031 K003782 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Feb 2001. https://www.510kdatabase.net/k004002/ 2001-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k004002-immulite-ck-mb-model-lkmb1-100-tests-fda-510k.jpg K004002 - IMMULITE CK-MB, MODEL LKMB1 (100 TESTS), LKMB5 (500 TESTS) K004002 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Feb 2001. https://www.510kdatabase.net/k010212/ 2001-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k010212-offset-tibial-tray-fda-510k.jpg K010212 - OFFSET TIBIAL TRAY K010212 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Feb 2001. https://www.510kdatabase.net/k010237/ 2001-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k010237-elecsys-hcgb-calcheck-fda-510k.jpg K010237 - ELECSYS HCG+B CALCHECK K010237 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Feb 2001. https://www.510kdatabase.net/k003853/ 2001-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k003853-infinion-15t-mr-imaging-system-model-fda-510k.jpg K003853 - INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100 K003853 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Feb 2001. https://www.510kdatabase.net/k010137/ 2001-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k010137-orbiter-ii-ccispect-orbiter-ii-ccispect-fda-510k.jpg K010137 - ORBITER II CCI/SPECT ORBITER II CCI/SPECT K010137 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 2001. https://www.510kdatabase.net/k010169/ 2001-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k010169-bard-utraverse-small-vessel-pta-fda-510k.jpg K010169 - BARD UTRAVERSE SMALL VESSEL PTA BALLOON DILATATION CATHETER K010169 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Feb 2001. https://www.510kdatabase.net/k003571/ 2001-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k003571-serono-for-use-with-gonal-f-1200iu-fda-510k.jpg K003571 - SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE K003571 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terumo Medical Corp.. Cleared Feb 2001. https://www.510kdatabase.net/k003493/ 2001-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k003493-3i-calcium-sodium-phosphate-bone-cement-fda-510k.jpg K003493 - 3I CALCIUM SODIUM PHOSPHATE BONE CEMENT K003493 is a FDA 510(k) cleared dental medical device. Manufacturer: Biomet, Inc.. Cleared Feb 2001. https://www.510kdatabase.net/k003499/ 2001-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k003499-remview-sleep-recorder-model-320-fda-510k.jpg K003499 - REMVIEW SLEEP RECORDER, MODEL 320 K003499 is a FDA 510(k) cleared neurology medical device. Manufacturer: Respironics, Inc.. Cleared Feb 2001. https://www.510kdatabase.net/k003743/ 2001-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k003743-synthes-modified-bioresorbable-suture-fda-510k.jpg K003743 - SYNTHES MODIFIED BIORESORBABLE SUTURE ANCHOR SYSTEM K003743 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Feb 2001. https://www.510kdatabase.net/k003800/ 2001-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k003800-aml-hip-prosthesis-fda-510k.jpg K003800 - AML HIP PROSTHESIS K003800 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Feb 2001. https://www.510kdatabase.net/k010120/ 2001-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k010120-modification-to-exactech-acumatch-fda-510k.jpg K010120 - MODIFICATION TO EXACTECH ACUMATCH INTEGRATED HIP SYSTEM, M-SERIES HIGH OFF-SET NECK SEGMENT, M-SERIES LOW OFF-SET NECK S K010120 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Feb 2001. https://www.510kdatabase.net/k010121/ 2001-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k010121-sterile-button-plate-fda-510k.jpg K010121 - STERILE BUTTON PLATE K010121 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Feb 2001. https://www.510kdatabase.net/k000943/ 2001-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k000943-cemex-system-gun-application-version-fda-510k.jpg K000943 - CEMEX SYSTEM GUN APPLICATION VERSION K000943 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Feb 2001. https://www.510kdatabase.net/k002068/ 2001-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k002068-org-9200a-fda-510k.jpg K002068 - ORG-9200A K002068 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Feb 2001. https://www.510kdatabase.net/k003535/ 2001-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k003535-stylet-kit-models-625462826293-fda-510k.jpg K003535 - STYLET KIT, MODELS 6254,6282,6293 K003535 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Feb 2001. https://www.510kdatabase.net/k010064/ 2001-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k010064-4c-es-cell-models-7547187-7547188-fda-510k.jpg K010064 - 4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190 K010064 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Feb 2001. https://www.510kdatabase.net/k010066/ 2001-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k010066-5c-es-cell-control-models-7547191-fda-510k.jpg K010066 - 5C-ES CELL CONTROL, MODELS 7547191, 7547192 K010066 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Feb 2001. https://www.510kdatabase.net/k003478/ 2001-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k003478-triology-acetabular-system-46mm-large-fda-510k.jpg K003478 - TRIOLOGY ACETABULAR SYSTEM 46MM LARGE HEAD LINERS, MODEL 6310 K003478 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Feb 2001. https://www.510kdatabase.net/k003597/ 2001-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k003597-immulite-homocysteine-model-lkho1-fda-510k.jpg K003597 - IMMULITE HOMOCYSTEINE MODEL LKHO1 / IMMULITE 2000 HOMOCYSTEINE MODEL L2KHO2 K003597 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Feb 2001. https://www.510kdatabase.net/k010081/ 2001-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k010081-acumatch-l-series-unipolar-fda-510k.jpg K010081 - ACUMATCH L-SERIES UNIPOLAR ENDOPROSTHESIS K010081 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Feb 2001. https://www.510kdatabase.net/k003437/ 2001-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k003437-odyssey-lx-model-211320-fda-510k.jpg K003437 - ODYSSEY LX, MODEL 211320 K003437 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Feb 2001. https://www.510kdatabase.net/k003636/ 2001-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k003636-portalvision-fda-510k.jpg K003636 - PORTALVISION K003636 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Feb 2001. https://www.510kdatabase.net/k003710/ 2001-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k003710-dyonics-vision-337-autoclavable-camera-fda-510k.jpg K003710 - DYONICS VISION 337 AUTOCLAVABLE CAMERA HEAD MODEL 7209048 K003710 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Feb 2001. https://www.510kdatabase.net/k003945/ 2001-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k003945-opdima-fda-510k.jpg K003945 - OPDIMA K003945 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 2001. https://www.510kdatabase.net/k003425/ 2001-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k003425-clirans-e-series-hollow-fiber-dialyzers-fda-510k.jpg K003425 - CLIRANS E-SERIES HOLLOW FIBER DIALYZERS K003425 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Terumo Medical Corp.. Cleared Feb 2001. https://www.510kdatabase.net/k003461/ 2001-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k003461-bd-vacutainer-passive-shielding-blood-fda-510k.jpg K003461 - BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE K003461 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Feb 2001. https://www.510kdatabase.net/k003930/ 2001-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k003930-flextime-magnum-360-fda-510k.jpg K003930 - FLEXTIME MAGNUM 360 K003930 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Feb 2001. https://www.510kdatabase.net/k010042/ 2001-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k010042-ct-perfusion-2-fda-510k.jpg K010042 - CT PERFUSION 2 K010042 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jan 2001. https://www.510kdatabase.net/k003397/ 2001-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k003397-colles-c-series-frame-sterile-pack-fda-510k.jpg K003397 - COLLES C SERIES FRAME STERILE PACK K003397 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jan 2001. https://www.510kdatabase.net/k003519/ 2001-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k003519-yasargil-permanent-aneurysm-clips-fda-510k.jpg K003519 - YASARGIL PERMANENT ANEURYSM CLIPS K003519 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Jan 2001. https://www.510kdatabase.net/k003577/ 2001-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k003577-steris-deepsite-fiber-optic-surgical-fda-510k.jpg K003577 - STERIS DEEPSITE FIBER OPTIC SURGICAL LIGHT K003577 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: STERIS Corporation. Cleared Jan 2001. https://www.510kdatabase.net/k003055/ 2001-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k003055-medline-sterile-powder-free-latex-fda-510k.jpg K003055 - MEDLINE STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) K003055 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Jan 2001. https://www.510kdatabase.net/k003409/ 2001-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k003409-elecsys-fsh-calset-ii-fda-510k.jpg K003409 - ELECSYS FSH CALSET II K003409 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jan 2001. https://www.510kdatabase.net/k001985/ 2001-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k001985-introdeuce-double-lumen-introducer-fda-510k.jpg K001985 - INTRODEUCE DOUBLE LUMEN INTRODUCER K001985 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Jan 2001. https://www.510kdatabase.net/k003576/ 2001-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k003576-q-tel-rms-rehabilitation-management-fda-510k.jpg K003576 - Q-TEL RMS (REHABILITATION MANAGEMENT SYSTEM), MODEL 000503 K003576 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Jan 2001. https://www.510kdatabase.net/k003696/ 2001-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k003696-stratus-cs-stat-fluorometric-analyzer-fda-510k.jpg K003696 - STRATUS CS STAT FLUOROMETRIC ANALYZER BHCG TESTPAK,TEST SYSTEM, MODEL CBHCG, BHCG CALPAK,MODEL CBHCG-C, BHCG DILPAK, MOD K003696 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Jan 2001. https://www.510kdatabase.net/k003941/ 2001-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k003941-elecsys-hcg-stat-claset-ii-fda-510k.jpg K003941 - ELECSYS HCG STAT CLASET II K003941 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jan 2001. https://www.510kdatabase.net/k003921/ 2001-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k003921-dyract-cem-lci-compomer-fda-510k.jpg K003921 - DYRACT CEM LCI COMPOMER K003921 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jan 2001. https://www.510kdatabase.net/k010034/ 2001-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k010034-double-lumen-urethane-picc-line-model-fda-510k.jpg K010034 - DOUBLE LUMEN URETHANE PICC LINE, MODEL UPICDS- K010034 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cook, Inc.. Cleared Jan 2001. https://www.510kdatabase.net/k002968/ 2001-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k002968-medline-sterilization-wrap-fda-510k.jpg K002968 - MEDLINE STERILIZATION WRAP K002968 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Jan 2001. https://www.510kdatabase.net/k003628/ 2001-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k003628-magnetom-rhapsody-system-fda-510k.jpg K003628 - MAGNETOM RHAPSODY SYSTEM K003628 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 2001. https://www.510kdatabase.net/k003959/ 2001-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k003959-quanta-lite-centromere-cenp-a-cenp-b-fda-510k.jpg K003959 - QUANTA LITE CENTROMERE (CENP-A & CENP-B) ELISA K003959 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Jan 2001. https://www.510kdatabase.net/k010002/ 2001-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k010002-contour-polaris-ureteral-stent-fda-510k.jpg K010002 - CONTOUR POLARIS URETERAL STENT K010002 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Jan 2001. https://www.510kdatabase.net/k003964/ 2001-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k003964-trapease-permanent-vena-filter-and-fda-510k.jpg K003964 - TRAPEASE PERMANENT VENA FILTER AND INTRODUCTION KIT, MODELS 466-P306A AND 466-P306B K003964 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Jan 2001. https://www.510kdatabase.net/k003174/ 2001-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k003174-elecsys-dhea-s-fda-510k.jpg K003174 - ELECSYS DHEA-S K003174 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jan 2001. https://www.510kdatabase.net/k003393/ 2001-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k003393-maxillary-distractor-fda-510k.jpg K003393 - MAXILLARY DISTRACTOR K003393 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Jan 2001. https://www.510kdatabase.net/k003575/ 2001-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k003575-modification-to-30t-signa-vhi-magnetic-fda-510k.jpg K003575 - MODIFICATION TO 3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM K003575 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Jan 2001. https://www.510kdatabase.net/k003253/ 2001-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k003253-biomets-minimally-constrained-elbow-fda-510k.jpg K003253 - BIOMET'S MINIMALLY CONSTRAINED ELBOW K003253 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jan 2001. https://www.510kdatabase.net/k003967/ 2001-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k003967-ca-125-ii-calcheck-fda-510k.jpg K003967 - CA 125 II CALCHECK K003967 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jan 2001. https://www.510kdatabase.net/k003969/ 2001-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k003969-elecsys-ca-125-ii-calset-fda-510k.jpg K003969 - ELECSYS CA 125 II CALSET K003969 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jan 2001. https://www.510kdatabase.net/k010027/ 2001-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k010027-maxim-knee-system-fda-510k.jpg K010027 - MAXIM KNEE SYSTEM K010027 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jan 2001. https://www.510kdatabase.net/k003273/ 2001-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k003273-lactosorb-screw-anchor-fda-510k.jpg K003273 - LACTOSORB SCREW ANCHOR K003273 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jan 2001. https://www.510kdatabase.net/k003848/ 2001-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k003848-hoffmann-ii-external-fixation-system-fda-510k.jpg K003848 - HOFFMANN II EXTERNAL FIXATION SYSTEM 90 DEGREE POST K003848 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jan 2001. https://www.510kdatabase.net/k000560/ 2001-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k000560-synthes-usa-resorbable-tack-system-fda-510k.jpg K000560 - SYNTHES (USA) RESORBABLE TACK SYSTEM K000560 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Jan 2001. https://www.510kdatabase.net/k003186/ 2001-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k003186-bard-memotherm-endoscopic-biliary-stent-fda-510k.jpg K003186 - BARD MEMOTHERM ENDOSCOPIC BILIARY STENT K003186 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 2001. https://www.510kdatabase.net/k003518/ 2001-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k003518-rapidd-highspeed-dental-handpiece-fda-510k.jpg K003518 - RAPIDD HIGHSPEED DENTAL HANDPIECE K003518 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jan 2001. https://www.510kdatabase.net/k002717/ 2001-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k002717-sterile-piston-syringe-fda-510k.jpg K002717 - STERILE PISTON SYRINGE K002717 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Jan 2001. https://www.510kdatabase.net/k003164/ 2001-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k003164-trocars-trotec-with-automatic-fda-510k.jpg K003164 - TROCARS TROTEC WITH AUTOMATIC PROTECTIVE MECHANISM K003164 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Jan 2001. https://www.510kdatabase.net/k003227/ 2001-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k003227-bio-absorbable-corkscrew-model-ar-1920b-fda-510k.jpg K003227 - BIO-ABSORBABLE CORKSCREW MODEL AR-1920B K003227 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jan 2001. https://www.510kdatabase.net/k003289/ 2001-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k003289-bardex-latex-free-temperature-sensing-fda-510k.jpg K003289 - BARDEX LATEX-FREE TEMPERATURE-SENSING FOLEY CATHETER (UNCOATED) K003289 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 2001. https://www.510kdatabase.net/k003793/ 2001-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k003793-bard-luminexx-biliary-stent-fda-510k.jpg K003793 - BARD LUMINEXX BILIARY STENT K003793 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 2001. https://www.510kdatabase.net/k003956/ 2001-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k003956-bard-endocinch-suturing-system-000452-fda-510k.jpg K003956 - BARD ENDOCINCH SUTURING SYSTEM # 000452 K003956 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 2001. https://www.510kdatabase.net/k003240/ 2000-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k003240-biomet-external-wrist-plate-fda-510k.jpg K003240 - BIOMET EXTERNAL WRIST PLATE K003240 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Dec 2000. https://www.510kdatabase.net/k001738/ 2000-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k001738-depuy-restore-orthobiologic-soft-fda-510k.jpg K001738 - DEPUY RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT K001738 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Dec 2000. https://www.510kdatabase.net/k003372/ 2000-12-26 monthly 0.5 https://www.510kdatabase.net/og-image/k003372-immulite-high-sensitivity-crp-immulite-fda-510k.jpg K003372 - IMMULITE HIGH SENSITIVITY CRP, IMMULITE 2000 HIGH SENSITIVITY CRP K003372 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Dec 2000. https://www.510kdatabase.net/k003196/ 2000-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k003196-synchron-systems-ammonia-reagent-fda-510k.jpg K003196 - SYNCHRON SYSTEMS AMMONIA REAGENT K003196 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Dec 2000. https://www.510kdatabase.net/k003192/ 2000-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k003192-magnetic-concerto-fda-510k.jpg K003192 - MAGNETIC CONCERTO K003192 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Dec 2000. https://www.510kdatabase.net/k003243/ 2000-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k003243-siemens-infinity-modular-monitors-fda-510k.jpg K003243 - SIEMENS INFINITY MODULAR MONITORS MODEL SC 8000 K003243 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Dec 2000. https://www.510kdatabase.net/k003246/ 2000-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k003246-siemens-multi-view-workstation-with-fda-510k.jpg K003246 - SIEMENS MULTI VIEW WORKSTATION WITH VENT VIEWER OPTION K003246 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Dec 2000. https://www.510kdatabase.net/k003248/ 2000-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k003248-siemens-medical-information-bus-mib-fda-510k.jpg K003248 - SIEMENS MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER K003248 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Dec 2000. https://www.510kdatabase.net/k003598/ 2000-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k003598-datascope-profile-8fr-alt-b-iab-34cc-fda-510k.jpg K003598 - DATASCOPE PROFILE 8FR. ALT B IAB, 34CC, DATASCOPE PROFILE 8FR. ALT B IAB, 40CC, MODEL 0684-000319, 0684-00-0320 K003598 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Dec 2000. https://www.510kdatabase.net/k003623/ 2000-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k003623-interactive-real-time-scanning-package-fda-510k.jpg K003623 - INTERACTIVE REAL TIME SCANNING PACKAGE K003623 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Dec 2000. https://www.510kdatabase.net/k003724/ 2000-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k003724-cbmyotherm-xp-cardioplegia-delivery-fda-510k.jpg K003724 - CBMYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM WITH CARMEDA BIOACTIVE SURFACE, MODELS CB41 AND CB41-B K003724 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Dec 2000. https://www.510kdatabase.net/k003100/ 2000-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k003100-wallgraft-tracheobronchial-fda-510k.jpg K003100 - WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM K003100 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Boston Scientific Corp. Cleared Dec 2000. https://www.510kdatabase.net/k003564/ 2000-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k003564-hakim-programmer-and-transmitter-fda-510k.jpg K003564 - HAKIM PROGRAMMER AND TRANSMITTER K003564 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Dec 2000. https://www.510kdatabase.net/k003730/ 2000-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k003730-chemo-aide-dispensing-pin-fda-510k.jpg K003730 - CHEMO-AIDE DISPENSING PIN K003730 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Dec 2000. https://www.510kdatabase.net/k003772/ 2000-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k003772-elecsys-dhea-s-calcheck-fda-510k.jpg K003772 - ELECSYS DHEA-S CALCHECK K003772 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Dec 2000. https://www.510kdatabase.net/k003280/ 2000-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k003280-variant-ii-total-ghb-fda-510k.jpg K003280 - VARIANT II TOTAL GHB K003280 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bio-Rad. Cleared Dec 2000. https://www.510kdatabase.net/k002923/ 2000-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k002923-dynamic-joint-distractor-ii-external-fda-510k.jpg K002923 - DYNAMIC JOINT DISTRACTOR II EXTERNAL FIXATION SYSTEM K002923 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Dec 2000. https://www.510kdatabase.net/k003120/ 2000-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k003120-modification-to-integra-reagent-fda-510k.jpg K003120 - MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C K003120 is a FDA 510(k) cleared hematology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Dec 2000. https://www.510kdatabase.net/k003158/ 2000-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k003158-roche-diagnostics-ck-mb-fda-510k.jpg K003158 - ROCHE DIAGNOSTICS CK-MB K003158 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Dec 2000. https://www.510kdatabase.net/k003721/ 2000-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k003721-modification-to-olympus-au2700-fda-510k.jpg K003721 - MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER K003721 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus America, Inc.. Cleared Dec 2000. https://www.510kdatabase.net/k002747/ 2000-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k002747-reflection-cross-linked-uhmwpe-fda-510k.jpg K002747 - REFLECTION CROSS-LINKED UHMWPE ACETABULAR COMPONENTS K002747 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Dec 2000. https://www.510kdatabase.net/k003018/ 2000-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k003018-titan-tibial-nail-fda-510k.jpg K003018 - TITAN TIBIAL NAIL K003018 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Dec 2000. https://www.510kdatabase.net/k003211/ 2000-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k003211-hoffmann-ii-dynamizationdistraction-fda-510k.jpg K003211 - HOFFMANN II DYNAMIZATION/DISTRACTION ROD-TO-ROD COUPLING K003211 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Dec 2000. https://www.510kdatabase.net/k003363/ 2000-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k003363-m2a-32mm-taper-system-fda-510k.jpg K003363 - M2A 32MM TAPER SYSTEM K003363 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Dec 2000. https://www.510kdatabase.net/k003797/ 2000-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k003797-ace-aim-ttc-fusion-nail-fda-510k.jpg K003797 - ACE AIM TTC FUSION NAIL K003797 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Dec 2000. https://www.510kdatabase.net/k003178/ 2000-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k003178-elecsys-hcg-and-beta-test-system-fda-510k.jpg K003178 - ELECSYS HCG AND BETA TEST SYSTEM K003178 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Dec 2000. https://www.510kdatabase.net/k003016/ 2000-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k003016-pro-femur-r-fda-510k.jpg K003016 - PRO-FEMUR R K003016 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Dec 2000. https://www.510kdatabase.net/k003044/ 2000-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k003044-copeland-resurfacing-heads-fda-510k.jpg K003044 - COPELAND RESURFACING HEADS K003044 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Dec 2000. https://www.510kdatabase.net/k003523/ 2000-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k003523-depuy-pinnacle-metal-on-metal-fda-510k.jpg K003523 - DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS K003523 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Dec 2000. https://www.510kdatabase.net/k003616/ 2000-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k003616-colleague-3cx-3-cx-volumetric-infusion-fda-510k.jpg K003616 - COLLEAGUE (3CX, 3, CX) VOLUMETRIC INFUSION PUMP K003616 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Dec 2000. https://www.510kdatabase.net/k001160/ 2000-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k001160-versabond-bone-cement-fda-510k.jpg K001160 - VERSABOND BONE CEMENT K001160 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Dec 2000. https://www.510kdatabase.net/k001956/ 2000-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k001956-trident-all-poly-cup-fda-510k.jpg K001956 - TRIDENT ALL POLY CUP K001956 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Dec 2000. https://www.510kdatabase.net/k002960/ 2000-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k002960-trilogy-acetabular-system-large-head-fda-510k.jpg K002960 - TRILOGY ACETABULAR SYSTEM LARGE HEAD LINER, MODEL 6353 K002960 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Dec 2000. https://www.510kdatabase.net/k002996/ 2000-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k002996-synergy-ha-coated-porous-femoral-stems-fda-510k.jpg K002996 - SYNERGY HA COATED POROUS FEMORAL STEMS K002996 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Dec 2000. https://www.510kdatabase.net/k003078/ 2000-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k003078-merit-drainage-depot-fda-510k.jpg K003078 - MERIT DRAINAGE DEPOT K003078 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Dec 2000. https://www.510kdatabase.net/k001895/ 2000-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k001895-auto-suture-premium-plus-ceea-fda-510k.jpg K001895 - AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER K001895 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Dec 2000. https://www.510kdatabase.net/k002868/ 2000-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k002868-bard-all-silicone-3-way-foley-catheter-fda-510k.jpg K002868 - BARD ALL-SILICONE 3-WAY FOLEY CATHETER K002868 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 2000. https://www.510kdatabase.net/k003490/ 2000-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k003490-opus-rod-fixation-system-fda-510k.jpg K003490 - OPUS ROD FIXATION SYSTEM K003490 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Dec 2000. https://www.510kdatabase.net/k002798/ 2000-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k002798-codman-craniosorb-absorbable-fixation-fda-510k.jpg K002798 - CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM DRILL BITS K002798 is a FDA 510(k) cleared dental medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Dec 2000. https://www.510kdatabase.net/k002105/ 2000-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k002105-siemens-infinity-sc-6002xl-enhanced-fda-510k.jpg K002105 - SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS K002105 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Dec 2000. https://www.510kdatabase.net/k003209/ 2000-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k003209-urine-opiates-opi-screen-flex-reagent-fda-510k.jpg K003209 - URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF93A K003209 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Dade Behring, Inc.. Cleared Dec 2000. https://www.510kdatabase.net/k003029/ 2000-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k003029-infusomat-p-fda-510k.jpg K003029 - INFUSOMAT P K003029 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Dec 2000. https://www.510kdatabase.net/k003245/ 2000-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k003245-heparin-lock-flush-syring-10-usp-fda-510k.jpg K003245 - HEPARIN LOCK FLUSH SYRING 10 USP UNITS/ML, HEPARIN LOCK FLUSH SYRINGE, 100 USP UNITS/ML K003245 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Dec 2000. https://www.510kdatabase.net/k003587/ 2000-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k003587-clearglide-precision-bipolar-device-fda-510k.jpg K003587 - CLEARGLIDE PRECISION BIPOLAR DEVICE K003587 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Dec 2000. https://www.510kdatabase.net/k003266/ 2000-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k003266-siremobil-iso-c-3d-fda-510k.jpg K003266 - SIREMOBIL ISO-C 3D K003266 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Dec 2000. https://www.510kdatabase.net/k003421/ 2000-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k003421-depuy-c-stem-system-fda-510k.jpg K003421 - DEPUY C-STEM SYSTEM K003421 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Dec 2000. https://www.510kdatabase.net/k000806/ 2000-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k000806-karl-storz-hysteromat-ii-fda-510k.jpg K000806 - KARL STORZ HYSTEROMAT II K000806 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Nov 2000. https://www.510kdatabase.net/k002740/ 2000-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k002740-tibial-patellar-components-for-the-fda-510k.jpg K002740 - TIBIAL & PATELLAR COMPONENTS FOR THE PROFIX & GENESIS II TOTAL KNEE SYSTEMS K002740 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Nov 2000. https://www.510kdatabase.net/k003239/ 2000-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k003239-liquichek-blood-gas-plus-co-oximeter-fda-510k.jpg K003239 - LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (800 SERIES), MODEL504,505,506 K003239 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Nov 2000. https://www.510kdatabase.net/k003242/ 2000-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k003242-liquichek-blood-gas-plus-co-oximeter-fda-510k.jpg K003242 - LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL), MODEL 621,622,623 K003242 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Nov 2000. https://www.510kdatabase.net/k003379/ 2000-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k003379-v-40c-taper-adapter-sleeve-fda-510k.jpg K003379 - V-40/C-TAPER ADAPTER SLEEVE K003379 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Nov 2000. https://www.510kdatabase.net/k003429/ 2000-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k003429-malloyhead-lateralized-press-fit-femoral-fda-510k.jpg K003429 - MALLOY/HEAD LATERALIZED PRESS-FIT FEMORAL K003429 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Nov 2000. https://www.510kdatabase.net/k002938/ 2000-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k002938-b-d-ultra-fine-iii-pen-needle-fda-510k.jpg K002938 - B-D ULTRA-FINE III PEN NEEDLE K002938 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Nov 2000. https://www.510kdatabase.net/k003030/ 2000-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k003030-lyphochek-hemoglobin-alc-linearity-set-fda-510k.jpg K003030 - LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET K003030 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bio-Rad. Cleared Nov 2000. https://www.510kdatabase.net/k002288/ 2000-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k002288-arndt-pediatric-endobronchial-blocker-fda-510k.jpg K002288 - ARNDT PEDIATRIC ENDOBRONCHIAL BLOCKER K002288 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Cook, Inc.. Cleared Nov 2000. https://www.510kdatabase.net/k003391/ 2000-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k003391-osteonics-alumina-c-taper-head-fda-510k.jpg K003391 - OSTEONICS ALUMINA C-TAPER HEAD K003391 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Nov 2000. https://www.510kdatabase.net/k002852/ 2000-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k002852-nt-protein-control-sl-fda-510k.jpg K002852 - N/T PROTEIN CONTROL SL K002852 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Nov 2000. https://www.510kdatabase.net/k003359/ 2000-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k003359-coloscreen-es-fda-510k.jpg K003359 - COLOSCREEN-ES K003359 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Nov 2000. https://www.510kdatabase.net/k003488/ 2000-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k003488-synchron-control-fda-510k.jpg K003488 - SYNCHRON CONTROL K003488 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Nov 2000. https://www.510kdatabase.net/k000651/ 2000-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k000651-detach-18-and-detach-11-neurological-fda-510k.jpg K000651 - DETACH 18 AND DETACH 11, NEUROLOGICAL EMBOLIZATION COIL SYSTEM K000651 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cook, Inc.. Cleared Nov 2000. https://www.510kdatabase.net/k002757/ 2000-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k002757-oncology-salvage-system-fda-510k.jpg K002757 - ONCOLOGY SALVAGE SYSTEM K002757 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Nov 2000. https://www.510kdatabase.net/k003413/ 2000-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k003413-alumina-v40-head-fda-510k.jpg K003413 - ALUMINA V40 HEAD K003413 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Nov 2000. https://www.510kdatabase.net/k003428/ 2000-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k003428-iss-offset-heads-fda-510k.jpg K003428 - ISS OFFSET HEADS K003428 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Nov 2000. https://www.510kdatabase.net/k002672/ 2000-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k002672-vypro-mesh-vicryl-prolene-partially-fda-510k.jpg K002672 - VYPRO MESH, VICRYL PROLENE PARTIALLY ABSORBABLE SYNTHETIC SURGICAL MESH K002672 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Nov 2000. https://www.510kdatabase.net/k002683/ 2000-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k002683-wmt-ultra-fit-modular-shoulder-system-fda-510k.jpg K002683 - WMT ULTRA-FIT MODULAR SHOULDER SYSTEM K002683 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Nov 2000. https://www.510kdatabase.net/k003336/ 2000-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k003336-modification-to-smart-nitinol-stent-fda-510k.jpg K003336 - MODIFICATION TO S.M.A.R.T NITINOL STENT TRANSHEPATIC BILIARY SYSTEM K003336 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Nov 2000. https://www.510kdatabase.net/k003353/ 2000-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k003353-medline-aloe-touch-sterile-nitrile-fda-510k.jpg K003353 - MEDLINE ALOE TOUCH STERILE NITRILE EXAMINATION GLOVES WITH ALOE VERA K003353 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Nov 2000. https://www.510kdatabase.net/k003365/ 2000-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k003365-smart-nitinol-stent-endosopic-billary-fda-510k.jpg K003365 - S.M.A.R.T NITINOL STENT ENDOSOPIC BILLARY SYSTEM (VARIOUS) K003365 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Nov 2000. https://www.510kdatabase.net/k003424/ 2000-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k003424-pinnacle-ro-ii-or-radifocus-introducer-fda-510k.jpg K003424 - PINNACLE R/O II OR RADIFOCUS INTRODUCER II K003424 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Nov 2000. https://www.510kdatabase.net/k002605/ 2000-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k002605-4025-mm-self-drilling-schanz-screw-fda-510k.jpg K002605 - 4.0/2.5 MM SELF-DRILLING SCHANZ SCREW K002605 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Nov 2000. https://www.510kdatabase.net/k002731/ 2000-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k002731-n-latex-b2-microglobulin-fda-510k.jpg K002731 - N LATEX B2-MICROGLOBULIN K002731 is a FDA 510(k) cleared immunology medical device. Manufacturer: Dade Behring, Inc.. Cleared Nov 2000. https://www.510kdatabase.net/k003098/ 2000-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k003098-access-ultrasensitive-hgh-calibrators-fda-510k.jpg K003098 - ACCESS ULTRASENSITIVE HGH CALIBRATORS K003098 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Nov 2000. https://www.510kdatabase.net/k003408/ 2000-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k003408-ct-cord-iq-option-10-fda-510k.jpg K003408 - CT CORD IQ OPTION 1.0 K003408 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Nov 2000. https://www.510kdatabase.net/k002080/ 2000-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k002080-behring-coagulation-system-model-bcs-fda-510k.jpg K002080 - BEHRING COAGULATION SYSTEM, MODEL BCS K002080 is a FDA 510(k) cleared hematology medical device. Manufacturer: Dade Behring, Inc.. Cleared Nov 2000. https://www.510kdatabase.net/k002935/ 2000-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k002935-synthes-15mm-ti-brow-lift-screw-fda-510k.jpg K002935 - SYNTHES 1.5MM TI BROW LIFT SCREW K002935 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Nov 2000. https://www.510kdatabase.net/k003261/ 2000-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k003261-creatinine-plus-fda-510k.jpg K003261 - CREATININE PLUS K003261 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Nov 2000. https://www.510kdatabase.net/k001685/ 2000-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k001685-psn-hemodialyzer-model-psn-130-150-170-fda-510k.jpg K001685 - PSN HEMODIALYZER, MODEL PSN 130, 150, 170, 210 K001685 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Nov 2000. https://www.510kdatabase.net/k001993/ 2000-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k001993-sof-tact-diabetes-management-system-fda-510k.jpg K001993 - SOF-TACT DIABETES MANAGEMENT SYSTEM K001993 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Nov 2000. https://www.510kdatabase.net/k002552/ 2000-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k002552-howmedica-osteonics-modular-rotating-fda-510k.jpg K002552 - HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE K002552 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Nov 2000. https://www.510kdatabase.net/k003179/ 2000-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k003179-siemens-multiview-infinity-telemetry-fda-510k.jpg K003179 - SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM K003179 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 2000. https://www.510kdatabase.net/k002473/ 2000-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k002473-wec-7101a-pocket-size-ecg-monitor-and-fda-510k.jpg K002473 - WEC-7101A POCKET SIZE ECG MONITOR AND ACCESSORIES K002473 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Nov 2000. https://www.510kdatabase.net/k001433/ 2000-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k001433-cns-9300-series-central-station-fda-510k.jpg K001433 - CNS-9300 SERIES CENTRAL STATION K001433 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Nov 2000. https://www.510kdatabase.net/k003070/ 2000-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k003070-ethibond-excel-valve-loop-suture-fda-510k.jpg K003070 - ETHIBOND EXCEL VALVE LOOP SUTURE K003070 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ethicon, Inc.. Cleared Nov 2000. https://www.510kdatabase.net/k003193/ 2000-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k003193-duplogrip-fda-510k.jpg K003193 - DUPLOGRIP K003193 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Nov 2000. https://www.510kdatabase.net/k003235/ 2000-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k003235-peri-ii-knee-fracture-system-fda-510k.jpg K003235 - PE.R.I. II KNEE FRACTURE SYSTEM K003235 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Nov 2000. https://www.510kdatabase.net/k003296/ 2000-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k003296-biomet-sck-knee-system-fda-510k.jpg K003296 - BIOMET SCK KNEE SYSTEM K003296 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Nov 2000. https://www.510kdatabase.net/k002509/ 2000-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k002509-novalis-shaped-beam-surgery-system-fda-510k.jpg K002509 - NOVALIS (SHAPED BEAM SURGERY SYSTEM) K002509 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab AG. Cleared Nov 2000. https://www.510kdatabase.net/k002704/ 2000-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k002704-ksea-miniature-neuroendoscope-fda-510k.jpg K002704 - KSEA MINIATURE NEUROENDOSCOPE K002704 is a FDA 510(k) cleared neurology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Nov 2000. https://www.510kdatabase.net/k002924/ 2000-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k002924-3d-endoscope-fda-510k.jpg K002924 - 3D ENDOSCOPE K002924 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Nov 2000. https://www.510kdatabase.net/k003294/ 2000-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k003294-biomet-lateral-troch-plate-fda-510k.jpg K003294 - BIOMET LATERAL TROCH PLATE K003294 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Nov 2000. https://www.510kdatabase.net/k002103/ 2000-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k002103-simplicity-spinal-system-fda-510k.jpg K002103 - SIMPLICITY SPINAL SYSTEM K002103 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Nov 2000. https://www.510kdatabase.net/k003131/ 2000-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k003131-modification-to-radiolucent-colles-fda-510k.jpg K003131 - MODIFICATION TO: RADIOLUCENT COLLES FRACTURE KIT K003131 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Nov 2000. https://www.510kdatabase.net/k002362/ 2000-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k002362-synthes-calcium-sulfate-bone-void-fda-510k.jpg K002362 - SYNTHES CALCIUM SULFATE BONE VOID FILLER PELLETS (SYNTHES PELLETS) K002362 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Nov 2000. https://www.510kdatabase.net/k002361/ 2000-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k002361-synthes-usa-locking-proximal-plating-l-fda-510k.jpg K002361 - SYNTHES (USA) LOCKING PROXIMAL PLATING (L-PTP) SYSTEM K002361 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Oct 2000. https://www.510kdatabase.net/k002611/ 2000-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k002611-signa-mfoi-magnetic-resonance-system-fda-510k.jpg K002611 - SIGNA MFO/I MAGNETIC RESONANCE SYSTEM K002611 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Oct 2000. https://www.510kdatabase.net/k001408/ 2000-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k001408-ksea-vascular-fiberscopes-fda-510k.jpg K001408 - KSEA VASCULAR FIBERSCOPES K001408 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Oct 2000. https://www.510kdatabase.net/k003159/ 2000-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k003159-cordis-slalom-pta-balloon-catheter-fda-510k.jpg K003159 - CORDIS SLALOM PTA BALLOON CATHETER K003159 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Oct 2000. https://www.510kdatabase.net/k002424/ 2000-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k002424-3d-angiographic-imaging-system-model-fda-510k.jpg K002424 - 3D ANGIOGRAPHIC IMAGING SYSTEM, MODEL XIDF-100A K002424 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Oct 2000. https://www.510kdatabase.net/k002918/ 2000-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k002918-olympus-crp-latex-immunoturbidimetric-fda-510k.jpg K002918 - OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT K002918 is a FDA 510(k) cleared immunology medical device. Manufacturer: Olympus America, Inc.. Cleared Oct 2000. https://www.510kdatabase.net/k002982/ 2000-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k002982-olympus-au2700-clinical-chemistry-fda-510k.jpg K002982 - OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER K002982 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus America, Inc.. Cleared Oct 2000. https://www.510kdatabase.net/k001693/ 2000-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k001693-life-scope-p-model-bsm-4100-series-fda-510k.jpg K001693 - LIFE SCOPE P, MODEL BSM-4100 SERIES K001693 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Oct 2000. https://www.510kdatabase.net/k003091/ 2000-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k003091-medline-sterile-vinyl-exam-gloves-fda-510k.jpg K003091 - MEDLINE STERILE VINYL EXAM GLOVES, POWDER FREE, YELLOW K003091 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Oct 2000. https://www.510kdatabase.net/k003152/ 2000-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k003152-somatom-smile-fda-510k.jpg K003152 - SOMATOM SMILE K003152 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 2000. https://www.510kdatabase.net/k001468/ 2000-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k001468-elecsys-ca-15-3-test-system-fda-510k.jpg K001468 - ELECSYS CA 15-3 TEST SYSTEM K001468 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Oct 2000. https://www.510kdatabase.net/k002261/ 2000-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k002261-mr-iii-fda-510k.jpg K002261 - MR-III K002261 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 2000. https://www.510kdatabase.net/k002788/ 2000-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k002788-ksea-neuro-fiberscope-fda-510k.jpg K002788 - KSEA NEURO-FIBERSCOPE K002788 is a FDA 510(k) cleared neurology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Oct 2000. https://www.510kdatabase.net/k002423/ 2000-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k002423-lactosorb-push-screw-fda-510k.jpg K002423 - LACTOSORB PUSH SCREW K002423 is a FDA 510(k) cleared dental medical device. Manufacturer: Biomet, Inc.. Cleared Oct 2000. https://www.510kdatabase.net/k002949/ 2000-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k002949-modification-to-datascope-profile-8fr-fda-510k.jpg K002949 - MODIFICATION TO DATASCOPE PROFILE 8FR. IAB, 34CC K002949 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Oct 2000. https://www.510kdatabase.net/k003125/ 2000-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k003125-sonoline-elegra-diagnostic-ultrasound-fda-510k.jpg K003125 - SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM K003125 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 2000. https://www.510kdatabase.net/k002905/ 2000-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k002905-access-thyroglobulin-reagents-on-the-fda-510k.jpg K002905 - ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER K002905 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Oct 2000. https://www.510kdatabase.net/k003225/ 2000-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k003225-solution-administration-sets-with-fda-510k.jpg K003225 - SOLUTION ADMINISTRATION SETS WITH CAPLESS LUER ACTIVATED VALVE K003225 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Oct 2000. https://www.510kdatabase.net/k000855/ 2000-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k000855-gunther-tulip-vena-cava-mreye-filter-set-fda-510k.jpg K000855 - GUNTHER TULIP VENA CAVA MREYE FILTER SET K000855 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Oct 2000. https://www.510kdatabase.net/k002700/ 2000-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k002700-ksea-unimat-12-fda-510k.jpg K002700 - KSEA UNIMAT 12 K002700 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Oct 2000. https://www.510kdatabase.net/k994121/ 2000-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k994121-small-stature-uss-fda-510k.jpg K994121 - SMALL STATURE USS K994121 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Oct 2000. https://www.510kdatabase.net/k002467/ 2000-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k002467-coaliza-protein-s-free-fda-510k.jpg K002467 - COALIZA PROTEIN S-FREE K002467 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Oct 2000. https://www.510kdatabase.net/k002858/ 2000-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k002858-xia-spine-system-fda-510k.jpg K002858 - XIA SPINE SYSTEM K002858 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Oct 2000. https://www.510kdatabase.net/k002871/ 2000-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k002871-modification-to-yasargil-aneurysm-clips-fda-510k.jpg K002871 - MODIFICATION TO YASARGIL ANEURYSM CLIPS K002871 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Oct 2000. https://www.510kdatabase.net/k002883/ 2000-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k002883-pinnacle-metal-on-metal-acetabular-cup-fda-510k.jpg K002883 - PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS K002883 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Oct 2000. https://www.510kdatabase.net/k002133/ 2000-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k002133-nir-billiary-stent-system-fda-510k.jpg K002133 - NIR BILLIARY STENT SYSTEM K002133 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Oct 2000. https://www.510kdatabase.net/k003014/ 2000-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k003014-somatom-emotion-ms-fda-510k.jpg K003014 - SOMATOM EMOTION MS K003014 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 2000. https://www.510kdatabase.net/k002179/ 2000-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k002179-magnetom-allegra-system-fda-510k.jpg K002179 - MAGNETOM ALLEGRA SYSTEM K002179 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 2000. https://www.510kdatabase.net/k002551/ 2000-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k002551-emit-2000-valproic-acid-assay-emit-fda-510k.jpg K002551 - EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIBRATORS, MODEL 4G019UL, 4G109UL K002551 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Oct 2000. https://www.510kdatabase.net/k002684/ 2000-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k002684-composix-ex-mesh-fda-510k.jpg K002684 - COMPOSIX E/X MESH K002684 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 2000. https://www.510kdatabase.net/k002974/ 2000-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k002974-emit-tox-acetaminophen-assay-model-fda-510k.jpg K002974 - EMIT TOX ACETAMINOPHEN ASSAY, MODEL 7A319UL K002974 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Oct 2000. https://www.510kdatabase.net/k002978/ 2000-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k002978-ligthspeed-30-ct-scanner-system-fda-510k.jpg K002978 - LIGTHSPEED 3.0 CT SCANNER SYSTEM K002978 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Oct 2000. https://www.510kdatabase.net/k002094/ 2000-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k002094-bard-memotherm-covered-esophageal-fda-510k.jpg K002094 - BARD MEMOTHERM COVERED ESOPHAGEAL STENT, MODEL MULTIPLE K002094 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 2000. https://www.510kdatabase.net/k002729/ 2000-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k002729-synthes-proximal-humeral-nail-fda-510k.jpg K002729 - SYNTHES PROXIMAL HUMERAL NAIL K002729 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Oct 2000. https://www.510kdatabase.net/k002998/ 2000-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k002998-biomet-bi-polar-shoulder-system-fda-510k.jpg K002998 - BIOMET BI-POLAR SHOULDER SYSTEM K002998 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Oct 2000. https://www.510kdatabase.net/k000886/ 2000-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k000886-spirol-epidural-catheter-fda-510k.jpg K000886 - SPIROL EPIDURAL CATHETER K000886 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Abbott Laboratories. Cleared Oct 2000. https://www.510kdatabase.net/k002505/ 2000-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k002505-xia-spine-system-fda-510k.jpg K002505 - XIA SPINE SYSTEM K002505 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Oct 2000. https://www.510kdatabase.net/k002760/ 2000-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k002760-elecsys-dhea-s-calset-fda-510k.jpg K002760 - ELECSYS DHEA-S CALSET K002760 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Oct 2000. https://www.510kdatabase.net/k002799/ 2000-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k002799-paragon-cze-2000-capillary-fda-510k.jpg K002799 - PARAGON CZE 2000 CAPILLARY ELECTROPHORESIS SYSTEM AND BUFFER-100 K002799 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Oct 2000. https://www.510kdatabase.net/k002802/ 2000-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k002802-rapid-exchange-tapertome-fda-510k.jpg K002802 - RAPID EXCHANGE TAPERTOME K002802 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Oct 2000. https://www.510kdatabase.net/k002804/ 2000-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k002804-n-protein-standard-sl-fda-510k.jpg K002804 - N PROTEIN STANDARD SL K002804 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Oct 2000. https://www.510kdatabase.net/k001460/ 2000-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k001460-vidas-h-pylori-igg-hpy-assay-model-30-fda-510k.jpg K001460 - VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192 K001460 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Oct 2000. https://www.510kdatabase.net/k002289/ 2000-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k002289-inqwire-diagnostic-guide-wire-fda-510k.jpg K002289 - INQWIRE DIAGNOSTIC GUIDE WIRE K002289 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Oct 2000. https://www.510kdatabase.net/k002772/ 2000-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k002772-ascent-xxl-closed-box-femoral-component-fda-510k.jpg K002772 - ASCENT XXL CLOSED BOX FEMORAL COMPONENT K002772 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Oct 2000. https://www.510kdatabase.net/k002710/ 2000-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k002710-modification-to-synthes-usa-trochanter-fda-510k.jpg K002710 - MODIFICATION TO SYNTHES (USA) TROCHANTER STABILIZATION PLATE (TSB) FOR DHS (LINE EXTENSION) K002710 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Sep 2000. https://www.510kdatabase.net/k002387/ 2000-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k002387-comfort-control-syringe-system-fda-510k.jpg K002387 - COMFORT CONTROL SYRINGE SYSTEM K002387 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Sep 2000. https://www.510kdatabase.net/k002452/ 2000-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k002452-3m-rely-x-veneer-cement-try-in-paster-fda-510k.jpg K002452 - 3M RELY X VENEER CEMENT TRY-IN PASTER K002452 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Sep 2000. https://www.510kdatabase.net/k002146/ 2000-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k002146-kodak-dryview-8610-laser-imager-for-fda-510k.jpg K002146 - KODAK DRYVIEW 8610 LASER IMAGER / FOR MAMMOGRAPHY K002146 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Sep 2000. https://www.510kdatabase.net/k000277/ 2000-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k000277-constellation-catheters-fda-510k.jpg K000277 - CONSTELLATION CATHETERS K000277 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Sep 2000. https://www.510kdatabase.net/k001647/ 2000-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k001647-bn-prospec-system-fda-510k.jpg K001647 - BN PROSPEC SYSTEM K001647 is a FDA 510(k) cleared immunology medical device. Manufacturer: Dade Behring, Inc.. Cleared Sep 2000. https://www.510kdatabase.net/k002541/ 2000-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k002541-protein-c-reagent-fda-510k.jpg K002541 - PROTEIN C REAGENT K002541 is a FDA 510(k) cleared hematology medical device. Manufacturer: Dade Behring, Inc.. Cleared Sep 2000. https://www.510kdatabase.net/k002865/ 2000-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k002865-liquichek-blood-gas-plus-e-control-fda-510k.jpg K002865 - LIQUICHEK BLOOD GAS PLUS E CONTROL, MODEL 576, 577, 578 K002865 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Sep 2000. https://www.510kdatabase.net/k002866/ 2000-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k002866-liquichek-blood-gas-plus-e-control-fda-510k.jpg K002866 - LIQUICHEK BLOOD GAS PLUS E CONTROL LEVEL 4, MODEL 574 K002866 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Sep 2000. https://www.510kdatabase.net/k001937/ 2000-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k001937-medline-electronic-positioning-chair-fda-510k.jpg K001937 - MEDLINE ELECTRONIC POSITIONING CHAIR K001937 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Medline Industries, Inc.. Cleared Sep 2000. https://www.510kdatabase.net/k001941/ 2000-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k001941-synthes-modular-foot-system-fda-510k.jpg K001941 - SYNTHES MODULAR FOOT SYSTEM K001941 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Sep 2000. https://www.510kdatabase.net/k001945/ 2000-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k001945-synthes-usa-medial-distal-tibia-plates-fda-510k.jpg K001945 - SYNTHES (USA) MEDIAL DISTAL TIBIA PLATES K001945 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Sep 2000. https://www.510kdatabase.net/k002654/ 2000-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k002654-howmedica-osteonics-shoulder-screw-fda-510k.jpg K002654 - HOWMEDICA OSTEONICS SHOULDER SCREW K002654 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Sep 2000. https://www.510kdatabase.net/k000664/ 2000-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k000664-vigilance-ccocedv-vigilance-fda-510k.jpg K000664 - VIGILANCE CCO/CEDV & VIGILANCE CCO/SVO2/CEDV MONITORS K000664 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Sep 2000. https://www.510kdatabase.net/k001901/ 2000-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k001901-poly-per-q-cath-picc-cathetermodel-fda-510k.jpg K001901 - POLY PER-Q-CATH PICC CATHETER,MODEL 3236100 AND POLY PER-Q-CATH MIDLINE CATHETER, MODEL 3134135 K001901 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Sep 2000. https://www.510kdatabase.net/k001918/ 2000-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k001918-ksea-percutaneous-foraminoscopy-set-fda-510k.jpg K001918 - KSEA PERCUTANEOUS FORAMINOSCOPY SET K001918 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Sep 2000. https://www.510kdatabase.net/k002678/ 2000-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k002678-ascent-knee-system-fda-510k.jpg K002678 - ASCENT KNEE SYSTEM K002678 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Sep 2000. https://www.510kdatabase.net/k002735/ 2000-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k002735-ascent-xxl-open-box-femoral-component-fda-510k.jpg K002735 - ASCENT XXL OPEN BOX FEMORAL COMPONENT K002735 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Sep 2000. https://www.510kdatabase.net/k002679/ 2000-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k002679-6060-multi-therapy-pump-model-2m9832-fda-510k.jpg K002679 - 6060 MULTI-THERAPY PUMP, MODEL 2M9832 K002679 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Sep 2000. https://www.510kdatabase.net/k002320/ 2000-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k002320-accolade-c-femoral-component-fda-510k.jpg K002320 - ACCOLADE C FEMORAL COMPONENT K002320 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Sep 2000. https://www.510kdatabase.net/k002517/ 2000-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k002517-uss-vas-fda-510k.jpg K002517 - USS VAS K002517 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Sep 2000. https://www.510kdatabase.net/k002739/ 2000-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k002739-infusor-patient-control-module-2ml-fda-510k.jpg K002739 - INFUSOR PATIENT CONTROL MODULE, 2ML, MODEL 2C1067K K002739 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Sep 2000. https://www.510kdatabase.net/k000705/ 2000-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k000705-respironics-silhouette-nasal-mask-fda-510k.jpg K000705 - RESPIRONICS SILHOUETTE NASAL MASK, MODELS 1003224 AND 1003223 K000705 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Sep 2000. https://www.510kdatabase.net/k002465/ 2000-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k002465-spectrum-2-reusable-full-face-mask-fda-510k.jpg K002465 - SPECTRUM 2 REUSABLE FULL FACE MASK, MODEL 1004884 AND 1004876 K002465 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Sep 2000. https://www.510kdatabase.net/k002026/ 2000-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k002026-capiox-arterial-filter-fda-510k.jpg K002026 - CAPIOX ARTERIAL FILTER K002026 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Sep 2000. https://www.510kdatabase.net/k994349/ 2000-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k994349-coaguchek-s-system-model-2138280-fda-510k.jpg K994349 - COAGUCHEK S SYSTEM, MODEL 2138280 K994349 is a FDA 510(k) cleared hematology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Sep 2000. https://www.510kdatabase.net/k001907/ 2000-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k001907-camit-diabetes-management-software-fda-510k.jpg K001907 - CAMIT DIABETES MANAGEMENT SOFTWARE K001907 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Sep 2000. https://www.510kdatabase.net/k002380/ 2000-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k002380-infusor-sv-infusor-lv-baxter-pain-fda-510k.jpg K002380 - INFUSOR SV, INFUSOR LV, BAXTER PAIN MANAGEMENT SYSTEM K002380 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Sep 2000. https://www.510kdatabase.net/k002609/ 2000-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k002609-tina-quant-rheumatoid-factors-ii-test-fda-510k.jpg K002609 - TINA-QUANT RHEUMATOID FACTORS II TEST SYSTEM K002609 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Sep 2000. https://www.510kdatabase.net/k994103/ 2000-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k994103-olympus-um-s30-25r-ultrasonic-probe-fda-510k.jpg K994103 - OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR GASTROINTESTINAL TRACT K994103 is a FDA 510(k) cleared radiology medical device. Manufacturer: Olympus America, Inc.. Cleared Sep 2000. https://www.510kdatabase.net/k002441/ 2000-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k002441-fenning-hip-stem-fda-510k.jpg K002441 - FENNING HIP STEM K002441 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Sep 2000. https://www.510kdatabase.net/k000517/ 2000-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k000517-life-scope-ec-model-bsm-1102-fda-510k.jpg K000517 - LIFE SCOPE EC, MODEL BSM-1102 K000517 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Aug 2000. https://www.510kdatabase.net/k001134/ 2000-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k001134-gazelle-balloon-dilatation-catheter-fda-510k.jpg K001134 - GAZELLE BALLOON DILATATION CATHETER K001134 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Aug 2000. https://www.510kdatabase.net/k001760/ 2000-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k001760-radiolucent-colles-fracture-kit-fda-510k.jpg K001760 - RADIOLUCENT COLLES FRACTURE KIT K001760 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Aug 2000. https://www.510kdatabase.net/k002149/ 2000-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k002149-lineage-acetabular-system-fda-510k.jpg K002149 - LINEAGE ACETABULAR SYSTEM K002149 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Aug 2000. https://www.510kdatabase.net/k002379/ 2000-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k002379-m2a-28mm-ringloc-liner-fda-510k.jpg K002379 - M2A 28MM RINGLOC LINER K002379 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Aug 2000. https://www.510kdatabase.net/k002453/ 2000-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k002453-access-toxo-igm-ii-reagents-for-use-on-fda-510k.jpg K002453 - ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 34470, 34475, AND 34479 K002453 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Aug 2000. https://www.510kdatabase.net/k002460/ 2000-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k002460-liquichek-lipids-control-model-641-642-fda-510k.jpg K002460 - LIQUICHEK LIPIDS CONTROL, MODEL 641, 642 K002460 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Aug 2000. https://www.510kdatabase.net/k001338/ 2000-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k001338-microvasive-rapid-exchange-biliary-fda-510k.jpg K001338 - MICROVASIVE RAPID EXCHANGE BILIARY BALLOON DILATATION CATHETER K001338 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Aug 2000. https://www.510kdatabase.net/k002312/ 2000-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k002312-proton-vision-70-fda-510k.jpg K002312 - PROTON VISION 7.0 K002312 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Aug 2000. https://www.510kdatabase.net/k002400/ 2000-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k002400-modification-of-acl-advance-fda-510k.jpg K002400 - MODIFICATION OF ACL ADVANCE K002400 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Aug 2000. https://www.510kdatabase.net/k002535/ 2000-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k002535-liquichec-blood-gas-pluse-control-with-fda-510k.jpg K002535 - LIQUICHEC BLOOD GAS PLUSE CONTROL WITH GLUCOSE, MODEL 511, 512, 513 K002535 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Aug 2000. https://www.510kdatabase.net/k002536/ 2000-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k002536-liquichek-blood-gas-plus-co-oximeter-fda-510k.jpg K002536 - LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL, MODELS 637, 638, 639 (RADIOMETER) K002536 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Aug 2000. https://www.510kdatabase.net/k001922/ 2000-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k001922-depuy-neuflex-pip-finger-fda-510k.jpg K001922 - DEPUY NEUFLEX PIP FINGER K001922 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Aug 2000. https://www.510kdatabase.net/k001991/ 2000-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k001991-titan-porocoat-hip-prosthesis-fda-510k.jpg K001991 - TITAN POROCOAT HIP PROSTHESIS K001991 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Aug 2000. https://www.510kdatabase.net/k002271/ 2000-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k002271-24mm-cortex-screw-self-tapping-fda-510k.jpg K002271 - 2.4MM CORTEX SCREW, SELF-TAPPING K002271 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Aug 2000. https://www.510kdatabase.net/k002365/ 2000-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k002365-datascope-reinforced-percutaneous-fda-510k.jpg K002365 - DATASCOPE REINFORCED PERCUTANEOUS CATHETER INTRODUCER SET K002365 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Aug 2000. https://www.510kdatabase.net/k001666/ 2000-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k001666-modification-to-intuitive-surgical-fda-510k.jpg K001666 - MODIFICATION TO INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM K001666 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Aug 2000. https://www.510kdatabase.net/k001720/ 2000-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k001720-synthes-sacral-bar-system-fda-510k.jpg K001720 - SYNTHES SACRAL BAR SYSTEM K001720 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Aug 2000. https://www.510kdatabase.net/k001740/ 2000-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k001740-ksea-monopolar-vaporization-electrodes-fda-510k.jpg K001740 - KSEA MONOPOLAR VAPORIZATION ELECTRODES K001740 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Aug 2000. https://www.510kdatabase.net/k001935/ 2000-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k001935-access-testosterone-reagents-for-use-fda-510k.jpg K001935 - ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33560, 33565 K001935 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Aug 2000. https://www.510kdatabase.net/k002148/ 2000-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k002148-elecsys-hcg-test-system-fda-510k.jpg K002148 - ELECSYS HCG TEST SYSTEM K002148 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Aug 2000. https://www.510kdatabase.net/k002120/ 2000-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k002120-liquichek-blood-gas-control-model-571-fda-510k.jpg K002120 - LIQUICHEK BLOOD GAS CONTROL, MODEL 571, 572, 573 K002120 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Aug 2000. https://www.510kdatabase.net/k001653/ 2000-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k001653-xia-spine-system-sacral-block-assembly-fda-510k.jpg K001653 - XIA SPINE SYSTEM SACRAL BLOCK ASSEMBLY K001653 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Aug 2000. https://www.510kdatabase.net/k002194/ 2000-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k002194-treatvision-fda-510k.jpg K002194 - TREATVISION K002194 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Aug 2000. https://www.510kdatabase.net/k002415/ 2000-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k002415-powerdrive-350-option-fda-510k.jpg K002415 - POWERDRIVE 350 OPTION K002415 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Aug 2000. https://www.510kdatabase.net/k001580/ 2000-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k001580-gross-femoral-component-fda-510k.jpg K001580 - GROSS FEMORAL COMPONENT K001580 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Aug 2000. https://www.510kdatabase.net/k001793/ 2000-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k001793-synthes-scalloped-distal-tibia-plate-fda-510k.jpg K001793 - SYNTHES SCALLOPED DISTAL TIBIA PLATE K001793 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Aug 2000. https://www.510kdatabase.net/k001706/ 2000-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k001706-wmt-modular-shoulder-system-fda-510k.jpg K001706 - WMT MODULAR SHOULDER SYSTEM K001706 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Aug 2000. https://www.510kdatabase.net/k001969/ 2000-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k001969-gt2-fusion-guide-wire-model-fda-510k.jpg K001969 - GT2 FUSION GUIDE WIRE, MODEL NTLHLJ180,NTLHLS180, NTLHLJ300, NTLHLS300 K001969 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Aug 2000. https://www.510kdatabase.net/k002008/ 2000-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k002008-surgical-dynamics-spinal-retractor-fda-510k.jpg K002008 - SURGICAL DYNAMICS SPINAL RETRACTOR K002008 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Aug 2000. https://www.510kdatabase.net/k002141/ 2000-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k002141-acumatch-p-series-press-fit-plasma-fda-510k.jpg K002141 - ACUMATCH P-SERIES PRESS-FIT PLASMA, ACUMATCH P-SERIES PRESS-FIT, ACUMATCH L-SERIES PRESS-FIT K002141 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Aug 2000. https://www.510kdatabase.net/den000007/ 2000-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/den000007-quanta-lite-asca-s-cerevisiae-igg-elisa-fda-510k.jpg DEN000007 - QUANTA LITE ASCA (S. CEREVISIAE) IGG ELISA DEN000007 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Aug 2000. https://www.510kdatabase.net/k001403/ 2000-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k001403-sigma-diagnostics-infinity-glucose-fda-510k.jpg K001403 - SIGMA DIAGNOSTICS INFINITY GLUCOSE REAGENT, MODELS 17-25, 17-100P, 17-500P, 17-2000P, 18-20, 18-100P K001403 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Aug 2000. https://www.510kdatabase.net/k001523/ 2000-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k001523-ultima-metal-on-metal-acetabular-cup-fda-510k.jpg K001523 - ULTIMA METAL-ON-METAL ACETABULAR CUP K001523 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Aug 2000. https://www.510kdatabase.net/k001565/ 2000-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k001565-steerable-retrograde-cardioplegia-fda-510k.jpg K001565 - STEERABLE RETROGRADE CARDIOPLEGIA CANNULA WITH AND WITHOUT DURAFLO TREATMENT, MODELS SRCO14MIB, DIISRCO14MIB K001565 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Aug 2000. https://www.510kdatabase.net/k002006/ 2000-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k002006-lifeshield-additive-piercing-pin-fda-510k.jpg K002006 - LIFESHIELD ADDITIVE PIERCING PIN K002006 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Aug 2000. https://www.510kdatabase.net/k002353/ 2000-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k002353-elecsys-ca-15-3-calcheck-fda-510k.jpg K002353 - ELECSYS CA 15-3 CALCHECK K002353 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Aug 2000. https://www.510kdatabase.net/k001492/ 2000-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k001492-quinton-q-stress-model-000483-fda-510k.jpg K001492 - QUINTON Q-STRESS, MODEL 000483 K001492 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Aug 2000. https://www.510kdatabase.net/k002225/ 2000-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k002225-or-tablemagnetom-open-viva-system-fda-510k.jpg K002225 - OR TABLE/MAGNETOM OPEN VIVA SYSTEM K002225 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 2000. https://www.510kdatabase.net/k002196/ 2000-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k002196-lyphochek-fertility-control-models-480-fda-510k.jpg K002196 - LYPHOCHEK FERTILITY CONTROL, MODELS 480, 481, 482, 483 K002196 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Aug 2000. https://www.510kdatabase.net/k984390/ 2000-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k984390-lactosorb-panels-and-fasteners-fda-510k.jpg K984390 - LACTOSORB PANELS AND FASTENERS K984390 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Aug 2000. https://www.510kdatabase.net/k000568/ 2000-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k000568-hdl-cholesterol-plus-fda-510k.jpg K000568 - HDL CHOLESTEROL PLUS K000568 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Aug 2000. https://www.510kdatabase.net/k001448/ 2000-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k001448-trident-acetabular-shells-ps-ha-fda-510k.jpg K001448 - TRIDENT ACETABULAR SHELLS: PS-HA K001448 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Aug 2000. https://www.510kdatabase.net/k001449/ 2000-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k001449-trident-acetabular-shells-ps-fda-510k.jpg K001449 - TRIDENT ACETABULAR SHELLS: PS K001449 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Aug 2000. https://www.510kdatabase.net/k001614/ 2000-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k001614-stryker-trauma-pelvic-set-fda-510k.jpg K001614 - STRYKER TRAUMA PELVIC SET K001614 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Aug 2000. https://www.510kdatabase.net/k001645/ 2000-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k001645-sysmex-automated-coagulation-analyzer-fda-510k.jpg K001645 - SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 K001645 is a FDA 510(k) cleared hematology medical device. Manufacturer: Dade Behring, Inc.. Cleared Aug 2000. https://www.510kdatabase.net/k991971/ 2000-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k991971-arthrex-chondral-dart-model-ar-4005b-18-fda-510k.jpg K991971 - ARTHREX CHONDRAL DART, MODEL AR-4005B-18 K991971 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Aug 2000. https://www.510kdatabase.net/k001400/ 2000-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k001400-elegra-millennium-enhanced-diagnostic-fda-510k.jpg K001400 - ELEGRA MILLENNIUM ENHANCED DIAGNOSTIC ULTRASOUND SYSTEM K001400 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 2000. https://www.510kdatabase.net/k992905/ 2000-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k992905-codman-craniosorb-absorbable-fixation-fda-510k.jpg K992905 - CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM K992905 is a FDA 510(k) cleared dental medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Aug 2000. https://www.510kdatabase.net/k002211/ 2000-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k002211-colleague-cx-volumetric-infusion-pump-fda-510k.jpg K002211 - COLLEAGUE CX VOLUMETRIC INFUSION PUMP 2M8161 AND VOLUMETERIC INFUSION PUMP 2M8151 K002211 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jul 2000. https://www.510kdatabase.net/k994161/ 2000-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k994161-synthes-bioresorbable-suture-anchor-fda-510k.jpg K994161 - SYNTHES BIORESORBABLE SUTURE ANCHOR K994161 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jul 2000. https://www.510kdatabase.net/k001385/ 2000-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k001385-howmedica-osteonics-radial-head-fda-510k.jpg K001385 - HOWMEDICA OSTEONICS RADIAL HEAD PROTHESIS K001385 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jul 2000. https://www.510kdatabase.net/k001419/ 2000-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k001419-solar-shoulder-offset-humeral-head-fda-510k.jpg K001419 - SOLAR SHOULDER OFFSET HUMERAL HEAD K001419 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jul 2000. https://www.510kdatabase.net/k001616/ 2000-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k001616-modification-to-syringe-prefilled-with-fda-510k.jpg K001616 - MODIFICATION TO SYRINGE PREFILLED WITH 0.9% SODIUM CHLORIDE K001616 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Jul 2000. https://www.510kdatabase.net/k002106/ 2000-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k002106-new-bio-moore-endo-head-taper-adapter-fda-510k.jpg K002106 - NEW BIO-MOORE ENDO HEAD, TAPER ADAPTER K002106 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jul 2000. https://www.510kdatabase.net/k001350/ 2000-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k001350-patient-matched-titanium-alloy-trochlea-fda-510k.jpg K001350 - PATIENT MATCHED TITANIUM ALLOY TROCHLEA K001350 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jul 2000. https://www.510kdatabase.net/k001466/ 2000-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k001466-vocom-silicone-system-fda-510k.jpg K001466 - VOCOM SILICONE SYSTEM K001466 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 2000. https://www.510kdatabase.net/k001982/ 2000-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k001982-tri-lock-hip-stem-fda-510k.jpg K001982 - TRI-LOCK HIP STEM K001982 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jul 2000. https://www.510kdatabase.net/k001957/ 2000-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k001957-modular-rotating-hinge-knee-tibial-fda-510k.jpg K001957 - MODULAR ROTATING HINGE KNEE TIBIAL ROTATING COMPONENT K001957 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jul 2000. https://www.510kdatabase.net/k001989/ 2000-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k001989-coonradmorrey-total-elbow-model-32-fda-510k.jpg K001989 - COONRAD/MORREY TOTAL ELBOW. MODEL 32-8105 SERIES K001989 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jul 2000. https://www.510kdatabase.net/k993706/ 2000-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k993706-elecsys-serum-b-crosslapsserum-fda-510k.jpg K993706 - ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY K993706 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jul 2000. https://www.510kdatabase.net/k001087/ 2000-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k001087-pta-balloon-catheter-fda-510k.jpg K001087 - PTA BALLOON CATHETER K001087 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Jul 2000. https://www.510kdatabase.net/k001376/ 2000-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k001376-ti-max-protrusio-cage-fda-510k.jpg K001376 - TI-MAX PROTRUSIO CAGE K001376 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jul 2000. https://www.510kdatabase.net/k002126/ 2000-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k002126-abbott-acclaim-encore-standard-tubing-fda-510k.jpg K002126 - ABBOTT ACCLAIM ENCORE STANDARD TUBING PUMP K002126 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Jul 2000. https://www.510kdatabase.net/k001844/ 2000-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k001844-modification-to-centaur-spinal-system-fda-510k.jpg K001844 - MODIFICATION TO CENTAUR SPINAL SYSTEM K001844 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jul 2000. https://www.510kdatabase.net/k002084/ 2000-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k002084-microvasive-lithotriptor-flexprobe-ii-fda-510k.jpg K002084 - MICROVASIVE LITHOTRIPTOR FLEXPROBE II K002084 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Jul 2000. https://www.510kdatabase.net/k001450/ 2000-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k001450-auto-suture-micro-surgiclip-clip-applier-fda-510k.jpg K001450 - AUTO SUTURE MICRO SURGICLIP CLIP APPLIER K001450 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Jul 2000. https://www.510kdatabase.net/k001843/ 2000-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k001843-smart-nitinol-stent-transhepatic-fda-510k.jpg K001843 - S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM K001843 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Jul 2000. https://www.510kdatabase.net/k001271/ 2000-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k001271-samarco-spider-plates-fda-510k.jpg K001271 - SAMARCO SPIDER PLATES K001271 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jul 2000. https://www.510kdatabase.net/k001906/ 2000-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k001906-elecsys-insulin-calset-fda-510k.jpg K001906 - ELECSYS INSULIN CALSET K001906 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jul 2000. https://www.510kdatabase.net/k994413/ 2000-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k994413-brainscan-fda-510k.jpg K994413 - BRAINSCAN K994413 is a FDA 510(k) cleared radiology medical device. Manufacturer: Brainlab AG. Cleared Jul 2000. https://www.510kdatabase.net/k001421/ 2000-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k001421-ontrak-testcup-501-model-3016633-fda-510k.jpg K001421 - ONTRAK TESTCUP 501, MODEL 3016633 K001421 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jul 2000. https://www.510kdatabase.net/k001886/ 2000-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k001886-apex-fixation-pins-fda-510k.jpg K001886 - APEX FIXATION PINS K001886 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jul 2000. https://www.510kdatabase.net/k990144/ 2000-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k990144-intuitive-surgical-endoscopic-fda-510k.jpg K990144 - INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENTS, INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEM K990144 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Jul 2000. https://www.510kdatabase.net/k001356/ 2000-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k001356-ontrak-testcup-pro-5-model-1986678-fda-510k.jpg K001356 - ONTRAK TESTCUP PRO-5, MODEL 1986678 K001356 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jul 2000. https://www.510kdatabase.net/k001625/ 2000-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k001625-pronova-nonabsorbable-suture-usp-fda-510k.jpg K001625 - PRONOVA NONABSORBABLE SUTURE, USP K001625 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Jul 2000. https://www.510kdatabase.net/k000062/ 2000-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k000062-cordis-trapease-permanent-vena-cava-fda-510k.jpg K000062 - CORDIS TRAPEASE PERMANENT VENA CAVA FILTER AND INTRODUCTION KIT K000062 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Jul 2000. https://www.510kdatabase.net/k001063/ 2000-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k001063-swan-ganz-synthetic-controlcath-fda-510k.jpg K001063 - SWAN-GANZ SYNTHETIC CONTROLCATH THERMODILUTION CATHETERS, MODELS C146F7, C146HF7, S146F7, S146HF7 K001063 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jul 2000. https://www.510kdatabase.net/k001778/ 2000-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k001778-porocoat-prodigy-hip-prosthesis-fda-510k.jpg K001778 - POROCOAT PRODIGY HIP PROSTHESIS K001778 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jul 2000. https://www.510kdatabase.net/k001789/ 2000-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k001789-seamguard-staple-line-reinforcement-fda-510k.jpg K001789 - SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL K001789 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Jul 2000. https://www.510kdatabase.net/k981089/ 2000-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k981089-tissomat-and-spray-set-fda-510k.jpg K981089 - TISSOMAT AND SPRAY SET K981089 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jul 2000. https://www.510kdatabase.net/k001135/ 2000-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k001135-6f-7f-introducing-catheters-modification-fda-510k.jpg K001135 - 6F & 7F INTRODUCING CATHETERS (MODIFICATION) K001135 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Jul 2000. https://www.510kdatabase.net/k993741/ 2000-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k993741-ez-ldl-cholesterol-test-system-fda-510k.jpg K993741 - EZ LDL CHOLESTEROL TEST SYSTEM K993741 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Jul 2000. https://www.510kdatabase.net/k001080/ 2000-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k001080-spine-system-evolution-fda-510k.jpg K001080 - SPINE SYSTEM EVOLUTION K001080 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aesculap, Inc.. Cleared Jun 2000. https://www.510kdatabase.net/k001417/ 2000-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k001417-ontrak-testcup-502-model-3016641-fda-510k.jpg K001417 - ONTRAK TESTCUP 502, MODEL 3016641 K001417 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jun 2000. https://www.510kdatabase.net/k001364/ 2000-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k001364-bd-directigen-flu-ab-fda-510k.jpg K001364 - BD DIRECTIGEN FLU A+B K001364 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jun 2000. https://www.510kdatabase.net/k001846/ 2000-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k001846-elecsys-insulin-calcheck-fda-510k.jpg K001846 - ELECSYS INSULIN CALCHECK K001846 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jun 2000. https://www.510kdatabase.net/k000683/ 2000-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k000683-modified-single-axle-total-elbow-fda-510k.jpg K000683 - MODIFIED SINGLE AXLE TOTAL ELBOW K000683 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jun 2000. https://www.510kdatabase.net/k001258/ 2000-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k001258-bx-transhepatic-biliary-stent-and-fda-510k.jpg K001258 - BX TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM K001258 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Jun 2000. https://www.510kdatabase.net/k001226/ 2000-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k001226-smith-nephew-rf-arthroscopic-wand-system-fda-510k.jpg K001226 - SMITH + NEPHEW RF ARTHROSCOPIC WAND SYSTEM K001226 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jun 2000. https://www.510kdatabase.net/k001569/ 2000-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k001569-infinity-amylase-reagent-procedure-no-fda-510k.jpg K001569 - INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568) K001569 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Jun 2000. https://www.510kdatabase.net/k001277/ 2000-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k001277-triflange-acetabular-cup-system-fda-510k.jpg K001277 - TRIFLANGE ACETABULAR CUP SYSTEM K001277 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jun 2000. https://www.510kdatabase.net/k001643/ 2000-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k001643-varis-14g-fda-510k.jpg K001643 - VARIS 1.4G K001643 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Jun 2000. https://www.510kdatabase.net/k994238/ 2000-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k994238-il-test-liquid-antithrombin-fda-510k.jpg K994238 - IL TEST LIQUID ANTITHROMBIN K994238 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jun 2000. https://www.510kdatabase.net/k000978/ 2000-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k000978-anatomic-total-knee-prosthesis-fda-510k.jpg K000978 - ANATOMIC TOTAL KNEE PROSTHESIS K000978 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jun 2000. https://www.510kdatabase.net/k000994/ 2000-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k000994-bipap-duet-lx-bi-level-system-fda-510k.jpg K000994 - BIPAP DUET LX BI-LEVEL SYSTEM K000994 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Jun 2000. https://www.510kdatabase.net/k001088/ 2000-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k001088-ultrasim-ct-system-fda-510k.jpg K001088 - ULTRASIM CT SYSTEM K001088 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Jun 2000. https://www.510kdatabase.net/k001064/ 2000-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k001064-behring-coagulation-timer-analyzer-bct-fda-510k.jpg K001064 - BEHRING COAGULATION TIMER ANALYZER (BCT) K001064 is a FDA 510(k) cleared hematology medical device. Manufacturer: Dade Behring, Inc.. Cleared Jun 2000. https://www.510kdatabase.net/k001067/ 2000-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k001067-dade-behring-coagulation-analyzer-bct-fda-510k.jpg K001067 - DADE BEHRING COAGULATION ANALYZER (BCT) K001067 is a FDA 510(k) cleared hematology medical device. Manufacturer: Dade Behring, Inc.. Cleared Jun 2000. https://www.510kdatabase.net/k001311/ 2000-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k001311-synthes-usa-oribital-mesh-plates-fda-510k.jpg K001311 - SYNTHES (USA) ORIBITAL MESH PLATES K001311 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jun 2000. https://www.510kdatabase.net/k001559/ 2000-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k001559-calcium-sulfate-pellets-fda-510k.jpg K001559 - CALCIUM SULFATE PELLETS K001559 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jun 2000. https://www.510kdatabase.net/k001733/ 2000-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k001733-allen-medullary-cement-plugs-zimmer-fda-510k.jpg K001733 - ALLEN MEDULLARY CEMENT PLUGS, ZIMMER POLY PLUG INTRAMEDULLARY SYSTEM, MODEL 8011 SERIES & 1109 & 8109 SERIES K001733 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jun 2000. https://www.510kdatabase.net/k000955/ 2000-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k000955-placer-model-6232-steerable-stylet-fda-510k.jpg K000955 - PLACER MODEL 6232 STEERABLE STYLET K000955 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jun 2000. https://www.510kdatabase.net/k000972/ 2000-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k000972-synthes-usa-trochanter-stabilization-fda-510k.jpg K000972 - SYNTHES (USA) TROCHANTER STABILIZATION PLATE FOR DHS K000972 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jun 2000. https://www.510kdatabase.net/k000996/ 2000-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k000996-trubyte-denture-cleanserpolishing-fda-510k.jpg K000996 - TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND K000996 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jun 2000. https://www.510kdatabase.net/k001507/ 2000-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k001507-microperforation-instrument-fda-510k.jpg K001507 - MICROPERFORATION INSTRUMENT K001507 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jun 2000. https://www.510kdatabase.net/k992532/ 2000-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k992532-vantex-central-venous-catheter-with-fda-510k.jpg K992532 - VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITHOUT AMC THROMBOSHIELD COATING K992532 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jun 2000. https://www.510kdatabase.net/k001534/ 2000-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k001534-pinnacle-acetabular-system-fda-510k.jpg K001534 - PINNACLE ACETABULAR SYSTEM K001534 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jun 2000. https://www.510kdatabase.net/k993335/ 2000-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k993335-synthes-reamerirrigatoraspirator-ria-fda-510k.jpg K993335 - SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM K993335 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jun 2000. https://www.510kdatabase.net/k001114/ 2000-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k001114-3m-quik-temp-temporization-material-fda-510k.jpg K001114 - 3M QUIK TEMP TEMPORIZATION MATERIAL K001114 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Jun 2000. https://www.510kdatabase.net/k001474/ 2000-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k001474-terumo-u-100-insulin-syring-fda-510k.jpg K001474 - TERUMO U-100 INSULIN SYRING K001474 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terumo Medical Corp.. Cleared Jun 2000. https://www.510kdatabase.net/k000798/ 2000-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k000798-talon-balloon-dilation-catheter-fda-510k.jpg K000798 - TALON BALLOON DILATION CATHETER K000798 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Jun 2000. https://www.510kdatabase.net/k000535/ 2000-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k000535-quanta-lite-lkm-1-elisa-fda-510k.jpg K000535 - QUANTA LITE LKM-1 ELISA K000535 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Jun 2000. https://www.510kdatabase.net/k001393/ 2000-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k001393-the-aptus-automated-application-of-the-fda-510k.jpg K001393 - THE APTUS, AUTOMATED APPLICATION OF THE GLIADIN IGA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY, ELISA FOR K001393 is a FDA 510(k) cleared immunology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Jun 2000. https://www.510kdatabase.net/k001548/ 2000-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k001548-modular-rotating-hinge-knee-crossover-fda-510k.jpg K001548 - MODULAR ROTATING HINGE KNEE CROSSOVER TIBIAL BEARING COMPONENTS K001548 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jun 2000. https://www.510kdatabase.net/k993772/ 2000-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k993772-x-coated-capiox-sx18-and-sx25-hollow-fda-510k.jpg K993772 - X-COATED CAPIOX SX18 AND SX25 HOLLOW FIBER OXYGENATOR WITH/ WITHOUT DETACHABLE HARDSHELL RESERVOIR K993772 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Jun 2000. https://www.510kdatabase.net/k994223/ 2000-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k994223-nephroscope-12-degrees-fda-510k.jpg K994223 - NEPHROSCOPE, 12 DEGREES K994223 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Jun 2000. https://www.510kdatabase.net/k001422/ 2000-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k001422-psn-hemodialyzer-models-psn-170-psn-210-fda-510k.jpg K001422 - PSN HEMODIALYZER, MODELS PSN 170, PSN 210 K001422 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jun 2000. https://www.510kdatabase.net/k001458/ 2000-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k001458-synchron-control-fda-510k.jpg K001458 - SYNCHRON CONTROL K001458 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jun 2000. https://www.510kdatabase.net/k994069/ 2000-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k994069-olympus-um-s30-25r-ultrasonic-probe-fda-510k.jpg K994069 - OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR URINARY USE K994069 is a FDA 510(k) cleared radiology medical device. Manufacturer: Olympus America, Inc.. Cleared Jun 2000. https://www.510kdatabase.net/k994106/ 2000-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k994106-olympus-um-s30-25r-ultrasonic-probe-fda-510k.jpg K994106 - OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY EQUIPMENT FOR BRONCHIAL USE K994106 is a FDA 510(k) cleared radiology medical device. Manufacturer: Olympus America, Inc.. Cleared Jun 2000. https://www.510kdatabase.net/k000463/ 2000-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k000463-immulite-h-pylori-igg-and-immulite-fda-510k.jpg K000463 - IMMULITE H. PYLORI IGG AND IMMULITE 2000 H. PYLORI IGG K000463 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jun 2000. https://www.510kdatabase.net/k000769/ 2000-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k000769-ksea-manhes-pneumotrocar-fda-510k.jpg K000769 - KSEA MANHES PNEUMOTROCAR K000769 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jun 2000. https://www.510kdatabase.net/k001014/ 2000-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k001014-elecsys-anti-tpo-calcheck-fda-510k.jpg K001014 - ELECSYS ANTI-TPO CALCHECK K001014 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jun 2000. https://www.510kdatabase.net/k001201/ 2000-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k001201-multix-compact-k-and-multix-l-fda-510k.jpg K001201 - MULTIX COMPACT K AND MULTIX L RADIOGRAPHIC X-RAY SYSTEMS K001201 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 2000. https://www.510kdatabase.net/k983068/ 2000-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k983068-reliance-family-of-washer-disinfectors-fda-510k.jpg K983068 - RELIANCE FAMILY OF WASHER-DISINFECTORS K983068 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared May 2000. https://www.510kdatabase.net/k001330/ 2000-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k001330-sovereign-bipolar-instruments-fda-510k.jpg K001330 - SOVEREIGN BIPOLAR INSTRUMENTS K001330 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared May 2000. https://www.510kdatabase.net/k000673/ 2000-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k000673-hysteroscope-operating-sheath-and-fda-510k.jpg K000673 - HYSTEROSCOPE OPERATING SHEATH AND INSERT, MODEL 8988.031/.041/.231/.241 K000673 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared May 2000. https://www.510kdatabase.net/k000802/ 2000-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k000802-spiral-imaging-option-fda-510k.jpg K000802 - SPIRAL IMAGING OPTION K000802 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared May 2000. https://www.510kdatabase.net/k000973/ 2000-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k000973-behring-coagulation-system-bcs-fda-510k.jpg K000973 - BEHRING COAGULATION SYSTEM (BCS) K000973 is a FDA 510(k) cleared hematology medical device. Manufacturer: Dade Behring, Inc.. Cleared May 2000. https://www.510kdatabase.net/k001373/ 2000-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k001373-liquichek-immunoassay-plus-control-fda-510k.jpg K001373 - LIQUICHEK IMMUNOASSAY PLUS CONTROL, MODEL 360, 361, 362, 363 K001373 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared May 2000. https://www.510kdatabase.net/k992085/ 2000-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k992085-abbott-imx-glycated-hemoglobin-ii-fda-510k.jpg K992085 - ABBOTT IMX GLYCATED HEMOGLOBIN II K992085 is a FDA 510(k) cleared hematology medical device. Manufacturer: Abbott Laboratories. Cleared May 2000. https://www.510kdatabase.net/k001256/ 2000-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k001256-control-plasma-n-fda-510k.jpg K001256 - CONTROL PLASMA N K001256 is a FDA 510(k) cleared hematology medical device. Manufacturer: Dade Behring, Inc.. Cleared May 2000. https://www.510kdatabase.net/k000760/ 2000-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k000760-reach-femoral-component-fda-510k.jpg K000760 - REACH FEMORAL COMPONENT K000760 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared May 2000. https://www.510kdatabase.net/k000957/ 2000-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k000957-hoffmann-ii-external-fixation-system-fda-510k.jpg K000957 - HOFFMANN II EXTERNAL FIXATION SYSTEM K000957 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared May 2000. https://www.510kdatabase.net/k001122/ 2000-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k001122-prolene-soft-polypropylene-fda-510k.jpg K001122 - PROLENE SOFT (POLYPROPYLENE), NONABSORBABALE SYNTHETIC SURGICAL MESH K001122 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared May 2000. https://www.510kdatabase.net/k001319/ 2000-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k001319-xia-spine-system-hooks-fda-510k.jpg K001319 - XIA SPINE SYSTEM HOOKS K001319 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared May 2000. https://www.510kdatabase.net/k994350/ 2000-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k994350-neer-iii-total-shoulder-system-fda-510k.jpg K994350 - NEER III TOTAL SHOULDER SYSTEM K994350 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared May 2000. https://www.510kdatabase.net/k000879/ 2000-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k000879-the-aptus-automated-application-of-the-fda-510k.jpg K000879 - THE APTUS (AUTOMATED) APPLICATION OF THE TG IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE K000879 is a FDA 510(k) cleared immunology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared May 2000. https://www.510kdatabase.net/k000880/ 2000-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k000880-the-aptus-automated-application-of-the-fda-510k.jpg K000880 - THE APTUS (AUTOMATED APPLICATION OF THE TPO IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE K000880 is a FDA 510(k) cleared immunology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared May 2000. https://www.510kdatabase.net/k993319/ 2000-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k993319-vidas-toxo-igg-ii-txg-assay-model-30-210-fda-510k.jpg K993319 - VIDAS TOXO IGG II (TXG) ASSAY MODEL 30 210 K993319 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared May 2000. https://www.510kdatabase.net/k000308/ 2000-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k000308-wallstent-biliary-endoprosthesis-fda-510k.jpg K000308 - WALLSTENT BILIARY ENDOPROSTHESIS K000308 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared May 2000. https://www.510kdatabase.net/k000784/ 2000-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k000784-the-cardiac-reader-system-fda-510k.jpg K000784 - THE CARDIAC READER SYSTEM K000784 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared May 2000. https://www.510kdatabase.net/k001335/ 2000-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k001335-acumatch-l-series-cemented-femoral-fda-510k.jpg K001335 - ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL L-SERIES CEMENTED K001335 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared May 2000. https://www.510kdatabase.net/k001451/ 2000-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k001451-modification-to-depuy-contour-fda-510k.jpg K001451 - MODIFICATION TO DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS K001451 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared May 2000. https://www.510kdatabase.net/k992320/ 2000-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k992320-megabello-percutaneous-transluminal-fda-510k.jpg K992320 - MEGABELLO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER K992320 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared May 2000. https://www.510kdatabase.net/k992543/ 2000-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k992543-heartstream-xlt-defibrillatormonitor-fda-510k.jpg K992543 - HEARTSTREAM XLT DEFIBRILLATOR/MONITOR, AC CHARGER, DC CHARGER, DATA CARD, SINGLE BAY ADAPTER, DEFIBRILLATOR PADS CABLE K992543 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared May 2000. https://www.510kdatabase.net/k993438/ 2000-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k993438-metal-on-metal-acetabular-system-fda-510k.jpg K993438 - METAL ON METAL ACETABULAR SYSTEM K993438 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared May 2000. https://www.510kdatabase.net/k000121/ 2000-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k000121-immage-immunochemistry-system-fda-510k.jpg K000121 - IMMAGE IMMUNOCHEMISTRY SYSTEM LIPOPROTEIN(A) LPAX REAGENT, ARRAY SYSTEM LIPOPROTEIN(A) LPA REAGENT, LIPOPROTEIN(A) CALIB K000121 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared May 2000. https://www.510kdatabase.net/k000155/ 2000-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k000155-elecsys-anti-thyroid-peroxidase-fda-510k.jpg K000155 - ELECSYS ANTI-THYROID PEROXIDASE ANTIBODY TEST SYSTEM K000155 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared May 2000. https://www.510kdatabase.net/k000281/ 2000-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k000281-wallstent-enternal-prosthesis-fda-510k.jpg K000281 - WALLSTENT ENTERNAL PROSTHESIS K000281 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared May 2000. https://www.510kdatabase.net/k000905/ 2000-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k000905-urethrotome-8667xxx-and-8670xxx-fda-510k.jpg K000905 - URETHROTOME 8667.XXX AND 8670.XXX K000905 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared May 2000. https://www.510kdatabase.net/k001198/ 2000-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k001198-datascope-nitinol-catheter-guide-wire-fda-510k.jpg K001198 - DATASCOPE NITINOL CATHETER GUIDE WIRE (145 CM), DATASCOPE NITINOL CATHETER GUIDE WIRE (175 CM), DATASCOPE NITINOL CATHET K001198 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared May 2000. https://www.510kdatabase.net/k001208/ 2000-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k001208-espirt-fda-510k.jpg K001208 - ESPIRT K001208 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared May 2000. https://www.510kdatabase.net/k000636/ 2000-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k000636-stryker-trauma-plating-system-fda-510k.jpg K000636 - STRYKER TRAUMA PLATING SYSTEM K000636 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared May 2000. https://www.510kdatabase.net/k000658/ 2000-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k000658-ers-radial-head-replacement-fda-510k.jpg K000658 - ERS RADIAL HEAD REPLACEMENT K000658 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared May 2000. https://www.510kdatabase.net/k000965/ 2000-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k000965-multi-axial-cross-mac-connector-fda-510k.jpg K000965 - MULTI-AXIAL CROSS (MAC) CONNECTOR K000965 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared May 2000. https://www.510kdatabase.net/k001145/ 2000-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k001145-sysmex-automated-coagulation-analyzer-fda-510k.jpg K001145 - SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000 K001145 is a FDA 510(k) cleared hematology medical device. Manufacturer: Dade Behring, Inc.. Cleared May 2000. https://www.510kdatabase.net/k001272/ 2000-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k001272-xia-spine-system-fda-510k.jpg K001272 - XIA SPINE SYSTEM K001272 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared May 2000. https://www.510kdatabase.net/k000606/ 2000-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k000606-synchron-systems-amphetamine-reagent-fda-510k.jpg K000606 - SYNCHRON SYSTEMS AMPHETAMINE REAGENT K000606 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared May 2000. https://www.510kdatabase.net/k000579/ 2000-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k000579-tempo-aqua-angiographic-catheter-fda-510k.jpg K000579 - TEMPO AQUA ANGIOGRAPHIC CATHETER K000579 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared May 2000. https://www.510kdatabase.net/k000506/ 2000-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k000506-bio-fastak-suture-anchor-model-ar-1324b-fda-510k.jpg K000506 - BIO-FASTAK SUTURE ANCHOR, MODEL AR-1324B K000506 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared May 2000. https://www.510kdatabase.net/k000682/ 2000-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k000682-synthes-large-fragment-dynamic-fda-510k.jpg K000682 - SYNTHES LARGE FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM K000682 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared May 2000. https://www.510kdatabase.net/k000445/ 2000-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k000445-medtronic-model-7499-extension-fda-510k.jpg K000445 - MEDTRONIC MODEL 7499 EXTENSION K000445 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Apr 2000. https://www.510kdatabase.net/k000684/ 2000-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k000684-small-fragment-dynamic-compression-fda-510k.jpg K000684 - SMALL FRAGMENT DYNAMIC COMPRESSION LOCKING (DCL) SYSTEM K000684 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Apr 2000. https://www.510kdatabase.net/k001136/ 2000-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k001136-cordis-introducer-guide-fda-510k.jpg K001136 - CORDIS INTRODUCER GUIDE K001136 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Apr 2000. https://www.510kdatabase.net/k001010/ 2000-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k001010-ascent-knee-revision-femoral-stem-fda-510k.jpg K001010 - ASCENT KNEE REVISION FEMORAL STEM K001010 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Apr 2000. https://www.510kdatabase.net/k001015/ 2000-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k001015-elecsys-thyroglobulin-calcheck-fda-510k.jpg K001015 - ELECSYS THYROGLOBULIN CALCHECK K001015 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Apr 2000. https://www.510kdatabase.net/k001138/ 2000-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k001138-affinity-20-micron-arterial-blood-fda-510k.jpg K001138 - AFFINITY 20 MICRON ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB353/CB354 K001138 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Apr 2000. https://www.510kdatabase.net/k000096/ 2000-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k000096-ontrak-teststik-for-methamphetamine-fda-510k.jpg K000096 - ONTRAK TESTSTIK FOR METHAMPHETAMINE, CAT. 1986686 K000096 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Apr 2000. https://www.510kdatabase.net/k000338/ 2000-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k000338-vitaport-3-fda-510k.jpg K000338 - VITAPORT 3 K000338 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Apr 2000. https://www.510kdatabase.net/k000649/ 2000-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k000649-sysmex-automated-coagulation-analyzer-fda-510k.jpg K000649 - SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 K000649 is a FDA 510(k) cleared hematology medical device. Manufacturer: Dade Behring, Inc.. Cleared Apr 2000. https://www.510kdatabase.net/k000762/ 2000-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k000762-moxifloxacin-5-ug-bbl-sensi-disc-fda-510k.jpg K000762 - MOXIFLOXACIN, 5 UG, BBL SENSI-DISC K000762 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 2000. https://www.510kdatabase.net/k000392/ 2000-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k000392-response-2000-hip-stem-fda-510k.jpg K000392 - RESPONSE 2000 HIP STEM K000392 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Apr 2000. https://www.510kdatabase.net/k000432/ 2000-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k000432-response-2000-cemented-hip-stem-fda-510k.jpg K000432 - RESPONSE 2000 CEMENTED HIP STEM K000432 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Apr 2000. https://www.510kdatabase.net/k001016/ 2000-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k001016-ge-logiq-700-fda-510k.jpg K001016 - GE LOGIQ 700 K001016 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Apr 2000. https://www.510kdatabase.net/k000212/ 2000-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k000212-ksea-chardonnes-morcellation-knife-fda-510k.jpg K000212 - KSEA CHARDONNES MORCELLATION KNIFE K000212 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Apr 2000. https://www.510kdatabase.net/k000875/ 2000-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k000875-assayed-qcs-12-cat-nos-970200-970500-fda-510k.jpg K000875 - ASSAYED QCS 1,2, CAT. NOS. 970200, 970500 K000875 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Apr 2000. https://www.510kdatabase.net/k000571/ 2000-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k000571-ge-logiq-700-fda-510k.jpg K000571 - GE LOGIQ 700 K000571 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Apr 2000. https://www.510kdatabase.net/k000874/ 2000-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k000874-urine-control-1-cat-no-903600-urine-fda-510k.jpg K000874 - URINE CONTROL 1, CAT. NO. 903600, URINE CONTROL 2, CAT. NO. 904100 K000874 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Apr 2000. https://www.510kdatabase.net/k000458/ 2000-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k000458-urine-benzodiazepines-benz-screen-flex-fda-510k.jpg K000458 - URINE BENZODIAZEPINES (BENZ) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A K000458 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Dade Behring, Inc.. Cleared Apr 2000. https://www.510kdatabase.net/k000603/ 2000-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k000603-spife-cholesterol-profile-kit-fda-510k.jpg K000603 - SPIFE CHOLESTEROL PROFILE KIT K000603 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Apr 2000. https://www.510kdatabase.net/k991755/ 2000-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k991755-medline-tender-wet-wound-dressing-fda-510k.jpg K991755 - MEDLINE TENDER WET WOUND DRESSING K991755 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medline Industries, Inc.. Cleared Apr 2000. https://www.510kdatabase.net/k993677/ 2000-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k993677-medtronic-clearview-intravascular-fda-510k.jpg K993677 - MEDTRONIC CLEARVIEW INTRAVASCULAR ARTERIOTOMY SHUNT K993677 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Apr 2000. https://www.510kdatabase.net/k000460/ 2000-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k000460-urine-amphetaminemethamphetamine-amph-fda-510k.jpg K000460 - URINE AMPHETAMINE/METHAMPHETAMINE (AMPH) SCREEN FLEX REAGENT, CATALOG NO. DF 90A K000460 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Dade Behring, Inc.. Cleared Apr 2000. https://www.510kdatabase.net/k000464/ 2000-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k000464-urine-opiates-opi-screen-flex-reagent-fda-510k.jpg K000464 - URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 90A K000464 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Dade Behring, Inc.. Cleared Apr 2000. https://www.510kdatabase.net/k000467/ 2000-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k000467-urine-cocaine-metabolite-coc-screen-fda-510k.jpg K000467 - URINE COCAINE METABOLITE (COC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 92A K000467 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Dade Behring, Inc.. Cleared Apr 2000. https://www.510kdatabase.net/k000486/ 2000-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k000486-abc-cervical-plating-system-fda-510k.jpg K000486 - ABC CERVICAL PLATING SYSTEM K000486 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aesculap, Inc.. Cleared Apr 2000. https://www.510kdatabase.net/k000494/ 2000-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k000494-synchron-systems-acetaminophen-actm-fda-510k.jpg K000494 - SYNCHRON SYSTEMS ACETAMINOPHEN (ACTM) REAGENT K000494 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Apr 2000. https://www.510kdatabase.net/k000558/ 2000-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k000558-synthes-usa-wrist-fusion-plates-wfp-fda-510k.jpg K000558 - SYNTHES (USA) WRIST FUSION PLATES (WFP) K000558 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Apr 2000. https://www.510kdatabase.net/k000112/ 2000-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k000112-acucam-concept-iv-models-a1222b-a1223b-fda-510k.jpg K000112 - ACUCAM CONCEPT IV, MODELS A1222B, A1223B, A1221B, A1121B, A1222C, A10402, A10403, A10401 K000112 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Apr 2000. https://www.510kdatabase.net/k000570/ 2000-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k000570-blue-max-balloon-dilatation-catheter-fda-510k.jpg K000570 - BLUE MAX BALLOON DILATATION CATHETER, MAXFORCE BALLOON CATHETER, XXL BALLOON DILATATION CATHATER, SYMMETRY BALLOON DILA K000570 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Apr 2000. https://www.510kdatabase.net/k000829/ 2000-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k000829-gatifloxacin-5-ug-bbl-sensi-disc-fda-510k.jpg K000829 - GATIFLOXACIN, 5 UG, BBL SENSI-DISC K000829 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 2000. https://www.510kdatabase.net/k994164/ 2000-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k994164-ontrak-teststik-2-for-cocainethc-cat-fda-510k.jpg K994164 - ONTRAK TESTSTIK 2 FOR COCAINE/THC, CAT. 1118579 K994164 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Apr 2000. https://www.510kdatabase.net/k000105/ 2000-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k000105-medtronic-extension-passer-tunneling-fda-510k.jpg K000105 - MEDTRONIC EXTENSION PASSER TUNNELING SYSTEM (38 CM), MODEL 3555-38 K000105 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Apr 2000. https://www.510kdatabase.net/k990830/ 2000-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k990830-malloryhead-calcar-replacement-with-fda-510k.jpg K990830 - MALLORY/HEAD CALCAR REPLACEMENT WITH INTERLOCKING SLOTS BI-METRIC POROUS COLLARED STEM WITH INTERLOCKING SLOTS K990830 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Apr 2000. https://www.510kdatabase.net/k000410/ 2000-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k000410-synchron-systems-alcohol-reagent-and-fda-510k.jpg K000410 - SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS K000410 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Apr 2000. https://www.510kdatabase.net/k993305/ 2000-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k993305-transluminal-balloon-dilatation-catheter-fda-510k.jpg K993305 - TRANSLUMINAL BALLOON DILATATION CATHETER K993305 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Apr 2000. https://www.510kdatabase.net/k000177/ 2000-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k000177-renegade-hi-flo-microcatheter-fda-510k.jpg K000177 - RENEGADE HI-FLO MICROCATHETER K000177 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Apr 2000. https://www.510kdatabase.net/k000527/ 2000-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k000527-accuclot-drvvt-screen-catalog-no-a6094-fda-510k.jpg K000527 - ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094 K000527 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Apr 2000. https://www.510kdatabase.net/k000528/ 2000-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k000528-accuclot-drvvt-confirm-catalog-no-a62119-fda-510k.jpg K000528 - ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119 K000528 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Apr 2000. https://www.510kdatabase.net/k992173/ 2000-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k992173-siphonguard-csf-control-device-fda-510k.jpg K992173 - SIPHONGUARD CSF CONTROL DEVICE K992173 is a FDA 510(k) cleared neurology medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Apr 2000. https://www.510kdatabase.net/k994165/ 2000-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k994165-ontrak-teststik-3-for-fda-510k.jpg K994165 - ONTRAK TESTSTIK 3 FOR COCAINE/MORPHINE/THC,CAT. 1118595 K994165 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Apr 2000. https://www.510kdatabase.net/k000461/ 2000-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k000461-urine-cannabinoids-thc-screen-flex-fda-510k.jpg K000461 - URINE CANNABINOIDS (THC) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 95A K000461 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Dade Behring, Inc.. Cleared Apr 2000. https://www.510kdatabase.net/k000462/ 2000-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k000462-urine-phencyclidine-pcp-screen-flex-fda-510k.jpg K000462 - URINE PHENCYCLIDINE (PCP) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 94A K000462 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Dade Behring, Inc.. Cleared Apr 2000. https://www.510kdatabase.net/k000753/ 2000-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k000753-cordis-13f-catheter-sheath-introducer-fda-510k.jpg K000753 - CORDIS 13F CATHETER SHEATH INTRODUCER K000753 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Apr 2000. https://www.510kdatabase.net/k000764/ 2000-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k000764-pediatric-fixation-rods-fda-510k.jpg K000764 - PEDIATRIC FIXATION RODS K000764 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Apr 2000. https://www.510kdatabase.net/k983657/ 2000-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k983657-osteonics-series-7000-ad-tibial-tray-fda-510k.jpg K983657 - OSTEONICS SERIES 7000 AD TIBIAL TRAY K983657 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Apr 2000. https://www.510kdatabase.net/k000466/ 2000-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k000466-urine-methadone-meth-screen-flex-fda-510k.jpg K000466 - URINE METHADONE (METH) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 93A K000466 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Dade Behring, Inc.. Cleared Apr 2000. https://www.510kdatabase.net/k000534/ 2000-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k000534-cobas-integra-reagent-cassette-for-fda-510k.jpg K000534 - COBAS INTEGRA REAGENT CASSETTE FOR RHEUMATOID FACTOR II K000534 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Apr 2000. https://www.510kdatabase.net/k000629/ 2000-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k000629-flextime-fda-510k.jpg K000629 - FLEXTIME K000629 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Apr 2000. https://www.510kdatabase.net/k992781/ 2000-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k992781-architech-afp-mastercheck-model-6c01-05-fda-510k.jpg K992781 - ARCHITECH AFP MASTERCHECK, MODEL 6C01-05 K992781 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Apr 2000. https://www.510kdatabase.net/k000080/ 2000-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k000080-asnis-iii-cannulated-screw-system-fda-510k.jpg K000080 - ASNIS III CANNULATED SCREW SYSTEM K000080 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Apr 2000. https://www.510kdatabase.net/k000459/ 2000-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k000459-urine-barbiturates-barb-screen-flex-fda-510k.jpg K000459 - URINE BARBITURATES (BARB) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF 96A K000459 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Dade Behring, Inc.. Cleared Apr 2000. https://www.510kdatabase.net/k000715/ 2000-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k000715-envoy-and-vista-brite-tip-fda-510k.jpg K000715 - ENVOY AND VISTA BRITE TIP K000715 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Mar 2000. https://www.510kdatabase.net/k000037/ 2000-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k000037-monofilament-biosyn-suture-fda-510k.jpg K000037 - MONOFILAMENT BIOSYN SUTURE K000037 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Mar 2000. https://www.510kdatabase.net/k000046/ 2000-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k000046-knight-endoscopic-spine-system-kess-fda-510k.jpg K000046 - KNIGHT ENDOSCOPIC SPINE SYSTEM (KESS) K000046 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Mar 2000. https://www.510kdatabase.net/k000717/ 2000-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k000717-smith-nephew-suturelok-model-7207321-fda-510k.jpg K000717 - SMITH & NEPHEW SUTURELOK, MODEL 7207321 K000717 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Mar 2000. https://www.510kdatabase.net/k000659/ 2000-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k000659-modification-to-softouch-diagnostic-fda-510k.jpg K000659 - MODIFICATION TO SOFTOUCH DIAGNOSTIC INTRAVASCULAR CAT K000659 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Mar 2000. https://www.510kdatabase.net/k000677/ 2000-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k000677-zuma-guide-catheters-fda-510k.jpg K000677 - ZUMA GUIDE CATHETERS K000677 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Mar 2000. https://www.510kdatabase.net/k994278/ 2000-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k994278-access-ostase-immunoenzymetric-assay-fda-510k.jpg K994278 - ACCESS OSTASE IMMUNOENZYMETRIC ASSAY K994278 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Mar 2000. https://www.510kdatabase.net/k000315/ 2000-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k000315-ventricular-analysis-toolkit-option-fda-510k.jpg K000315 - VENTRICULAR ANALYSIS TOOLKIT OPTION K000315 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Mar 2000. https://www.510kdatabase.net/k000021/ 2000-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k000021-aesculap-bone-wax-fda-510k.jpg K000021 - AESCULAP BONE WAX K000021 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Mar 2000. https://www.510kdatabase.net/k000169/ 2000-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k000169-nupro-prophylaxis-paste-with-fluoride-fda-510k.jpg K000169 - NUPRO PROPHYLAXIS PASTE WITH FLUORIDE AND TRICLOSAN K000169 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Mar 2000. https://www.510kdatabase.net/k000821/ 2000-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k000821-abbott-gemstar-iv-infusion-pump-7-fda-510k.jpg K000821 - ABBOTT GEMSTAR I.V. INFUSION PUMP - 7 THERAPY CONFIGURATION, 6 THERAPY CONFIGURATION, 1 THERAPY CONFIGURATION K000821 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Mar 2000. https://www.510kdatabase.net/k000306/ 2000-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k000306-pinnacle-acetabular-system-fda-510k.jpg K000306 - PINNACLE ACETABULAR SYSTEM K000306 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Mar 2000. https://www.510kdatabase.net/k000564/ 2000-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k000564-cordis-medium-palmaz-transhepatic-fda-510k.jpg K000564 - CORDIS MEDIUM PALMAZ TRANSHEPATIC BILIARY STENT & DELIVERY K000564 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Mar 2000. https://www.510kdatabase.net/k993303/ 2000-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k993303-semi-compliant-sc-35-balloon-fda-510k.jpg K993303 - SEMI COMPLIANT (SC) 35 BALLOON DILATATION CATHETER K993303 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Mar 2000. https://www.510kdatabase.net/k000576/ 2000-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k000576-elecsys-cortisol-calcheck-fda-510k.jpg K000576 - ELECSYS CORTISOL CALCHECK K000576 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Mar 2000. https://www.510kdatabase.net/k000716/ 2000-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k000716-access-ck-mb-on-the-access-immunoassay-fda-510k.jpg K000716 - ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER K000716 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Mar 2000. https://www.510kdatabase.net/k992530/ 2000-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k992530-bipap-synchrony-hc-fda-510k.jpg K992530 - BIPAP SYNCHRONY HC K992530 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Mar 2000. https://www.510kdatabase.net/k994290/ 2000-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k994290-bard-endoscopic-suturing-system-fda-510k.jpg K994290 - BARD ENDOSCOPIC SUTURING SYSTEM K994290 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 2000. https://www.510kdatabase.net/k000042/ 2000-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k000042-elecsys-b-crosslaps-calcheck-fda-510k.jpg K000042 - ELECSYS B-CROSSLAPS CALCHECK K000042 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Mar 2000. https://www.510kdatabase.net/k000077/ 2000-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k000077-steris-amsco-millennium-steam-sterilizer-fda-510k.jpg K000077 - STERIS AMSCO MILLENNIUM STEAM STERILIZER K000077 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Mar 2000. https://www.510kdatabase.net/k990504/ 2000-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k990504-memotherm-colorectal-stent-fda-510k.jpg K990504 - MEMOTHERM COLORECTAL STENT K990504 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 2000. https://www.510kdatabase.net/k994366/ 2000-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k994366-tmzf-press-fit-ha-stem-and-tmzf-press-fda-510k.jpg K994366 - TMZF PRESS FIT HA STEM AND TMZF PRESS FIT PLUS HA STEM K994366 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Mar 2000. https://www.510kdatabase.net/k000053/ 2000-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k000053-acl-9000-system-fda-510k.jpg K000053 - ACL 9000 SYSTEM K000053 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Mar 2000. https://www.510kdatabase.net/k000066/ 2000-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k000066-synthes-usa-locking-condylar-plate-lcp-fda-510k.jpg K000066 - SYNTHES (USA) LOCKING CONDYLAR PLATE (LCP) SYSTEM K000066 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Mar 2000. https://www.510kdatabase.net/k000538/ 2000-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k000538-malloryhead-lateralized-press-fit-fda-510k.jpg K000538 - MALLORY/HEAD LATERALIZED PRESS-FIT FEMORAL K000538 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Mar 2000. https://www.510kdatabase.net/k990975/ 2000-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k990975-in-line-hemostasis-valve-fda-510k.jpg K990975 - IN-LINE HEMOSTASIS VALVE K990975 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Mar 2000. https://www.510kdatabase.net/k994347/ 2000-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k994347-centaur-spinal-system-fda-510k.jpg K994347 - CENTAUR SPINAL SYSTEM K994347 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Mar 2000. https://www.510kdatabase.net/k994364/ 2000-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k994364-synthes-button-plate-fda-510k.jpg K994364 - SYNTHES BUTTON PLATE K994364 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Mar 2000. https://www.510kdatabase.net/k994285/ 2000-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k994285-orthoralix-9200-orthoralix-9200-plus-fda-510k.jpg K994285 - ORTHORALIX 9200, ORTHORALIX 9200 PLUS, ORTHORALIX 9200 CEPH, ORTHORALIX 9200 PLUS CEPH K994285 is a FDA 510(k) cleared radiology medical device. Manufacturer: Dentsply Intl.. Cleared Mar 2000. https://www.510kdatabase.net/k991413/ 2000-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k991413-codman-ethisorb-dura-patch-fda-510k.jpg K991413 - CODMAN ETHISORB DURA PATCH K991413 is a FDA 510(k) cleared neurology medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Mar 2000. https://www.510kdatabase.net/k994157/ 2000-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k994157-datascopes-8fr-polymide-25cc34cc-and-fda-510k.jpg K994157 - DATASCOPE'S 8FR. POLYMIDE 25CC,34CC AND 40CC IAB AND ACCESSORIES, MODELS 0684-00-0327, 06844-00-0328, 0684-00-0329 K994157 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Mar 2000. https://www.510kdatabase.net/k994207/ 2000-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k994207-howmedica-osteonics-modular-rotating-fda-510k.jpg K994207 - HOWMEDICA OSTEONICS MODULAR ROTATING HINGE KNEE K994207 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Mar 2000. https://www.510kdatabase.net/k994365/ 2000-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k994365-dyonics-electroblade-fda-510k.jpg K994365 - DYONICS ELECTROBLADE K994365 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Mar 2000. https://www.510kdatabase.net/k000009/ 2000-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k000009-spiral-radius-rodding-system-fda-510k.jpg K000009 - SPIRAL RADIUS RODDING SYSTEM K000009 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Mar 2000. https://www.510kdatabase.net/k000091/ 2000-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k000091-duracon-symmetric-metal-backed-fda-510k.jpg K000091 - DURACON SYMMETRIC METAL-BACKED PATELLAR COMPONENT K000091 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Mar 2000. https://www.510kdatabase.net/k000575/ 2000-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k000575-global-advantage-extended-humeral-head-fda-510k.jpg K000575 - GLOBAL ADVANTAGE EXTENDED HUMERAL HEAD K000575 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Mar 2000. https://www.510kdatabase.net/k994286/ 2000-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k994286-zmr-hip-system-porous-revision-fda-510k.jpg K994286 - ZMR HIP SYSTEM-POROUS REVISION K994286 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Mar 2000. https://www.510kdatabase.net/k000657/ 2000-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k000657-luer-access-universal-vial-adapter-fda-510k.jpg K000657 - LUER ACCESS UNIVERSAL VIAL ADAPTER K000657 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 2000. https://www.510kdatabase.net/k994375/ 2000-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k994375-horizon-light-fda-510k.jpg K994375 - HORIZON LIGHT K994375 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Mar 2000. https://www.510kdatabase.net/k000270/ 2000-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k000270-elecsys-cortisol-test-system-fda-510k.jpg K000270 - ELECSYS CORTISOL TEST SYSTEM K000270 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Mar 2000. https://www.510kdatabase.net/k000397/ 2000-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k000397-speedband-superview-multiple-band-fda-510k.jpg K000397 - SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228 K000397 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Mar 2000. https://www.510kdatabase.net/k993456/ 2000-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k993456-sas-strep-a-test-fda-510k.jpg K993456 - SAS STREP A TEST K993456 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Mar 2000. https://www.510kdatabase.net/k992908/ 2000-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k992908-q-tel-telemetry-system-v-60-st-fda-510k.jpg K992908 - Q-TEL TELEMETRY SYSTEM V. 6.0 (ST) K992908 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Mar 2000. https://www.510kdatabase.net/k994128/ 2000-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k994128-scorpio-total-stablizer-ts-total-knee-fda-510k.jpg K994128 - SCORPIO TOTAL STABLIZER (TS) TOTAL KNEE SYSTEM K994128 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Mar 2000. https://www.510kdatabase.net/k994363/ 2000-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k994363-instruments-for-minimally-invasive-fda-510k.jpg K994363 - INSTRUMENTS FOR MINIMALLY INVASIVE SPINAL SURGERY (MISS) K994363 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Mar 2000. https://www.510kdatabase.net/k000005/ 2000-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k000005-immulite-valproic-acid-immulite-2000-fda-510k.jpg K000005 - IMMULITE VALPROIC ACID, IMMULITE 2000 VALPROIC ACID, CATALOG # LKVA1, LKVA5 & L2KVA2, L2KVA6 K000005 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Mar 2000. https://www.510kdatabase.net/k000012/ 2000-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k000012-immulite-phenobarbital-models-lkpb1-fda-510k.jpg K000012 - IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5 K000012 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Mar 2000. https://www.510kdatabase.net/k994341/ 2000-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k994341-fibrinogen-calibrator-kit-fda-510k.jpg K994341 - FIBRINOGEN CALIBRATOR KIT K994341 is a FDA 510(k) cleared hematology medical device. Manufacturer: Dade Behring, Inc.. Cleared Mar 2000. https://www.510kdatabase.net/k994348/ 2000-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k994348-ksea-scb-rui-fda-510k.jpg K994348 - KSEA SCB-RUI K994348 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Mar 2000. https://www.510kdatabase.net/k000387/ 2000-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k000387-terumo-needle-with-locking-sheath-fda-510k.jpg K000387 - TERUMO NEEDLE WITH LOCKING SHEATH K000387 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terumo Medical Corp.. Cleared Mar 2000. https://www.510kdatabase.net/k993170/ 2000-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k993170-medline-breathable-impervious-fda-510k.jpg K993170 - MEDLINE BREATHABLE, IMPERVIOUS DISPOSABLE SURGICAL GOWNS K993170 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Mar 2000. https://www.510kdatabase.net/k000533/ 2000-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k000533-vocom-implant-8mm-fda-510k.jpg K000533 - VOCOM IMPLANT- 8MM K000533 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Mar 2000. https://www.510kdatabase.net/k994291/ 2000-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k994291-dimension-special-protein-calibrator-fda-510k.jpg K994291 - DIMENSION SPECIAL PROTEIN CALIBRATOR K994291 is a FDA 510(k) cleared immunology medical device. Manufacturer: Dade Behring, Inc.. Cleared Mar 2000. https://www.510kdatabase.net/k994293/ 2000-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k994293-dimension-c4-flex-reagent-cartridge-fda-510k.jpg K994293 - DIMENSION C4 FLEX REAGENT CARTRIDGE K994293 is a FDA 510(k) cleared immunology medical device. Manufacturer: Dade Behring, Inc.. Cleared Mar 2000. https://www.510kdatabase.net/k994296/ 2000-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k994296-dimension-c3-flex-reagent-cartridge-fda-510k.jpg K994296 - DIMENSION C3 FLEX REAGENT CARTRIDGE K994296 is a FDA 510(k) cleared immunology medical device. Manufacturer: Dade Behring, Inc.. Cleared Mar 2000. https://www.510kdatabase.net/k000006/ 2000-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k000006-immulite-phenytoin-immulite-2000-fda-510k.jpg K000006 - IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LKPN5 & L2KPN2, L2KPN6 K000006 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Feb 2000. https://www.510kdatabase.net/k000007/ 2000-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k000007-immulite-carbamazepine-immulite-2000-fda-510k.jpg K000007 - IMMULITE CARBAMAZEPINE, IMMULITE 2000 CARBAMAZEPINE, CATALOG # LKCB1, LKCB5 & L2KCB2, L2KCB6 K000007 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Feb 2000. https://www.510kdatabase.net/k000409/ 2000-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k000409-modification-to-t-rex-biopsy-forceps-fda-510k.jpg K000409 - MODIFICATION TO T-REX BIOPSY FORCEPS K000409 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Feb 2000. https://www.510kdatabase.net/k000335/ 2000-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k000335-mallory-head-modular-calcar-total-hip-fda-510k.jpg K000335 - MALLORY-HEAD MODULAR CALCAR TOTAL HIP SYSTEM K000335 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Feb 2000. https://www.510kdatabase.net/k000430/ 2000-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k000430-affinity-nt-hollow-fiber-oxygenator-fda-510k.jpg K000430 - AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH CARMEDA BIOACTIVE SURFACE, MODEL CB511 K000430 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Feb 2000. https://www.510kdatabase.net/k992220/ 2000-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k992220-radial-head-prosthesis-fda-510k.jpg K992220 - RADIAL HEAD PROSTHESIS K992220 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Feb 2000. https://www.510kdatabase.net/k994202/ 2000-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k994202-acufex-spiked-washer-system-acufex-fda-510k.jpg K994202 - ACUFEX SPIKED WASHER SYSTEM, ACUFEX SUTURE WASHER SYSTEM, ACUFEX CANCELLOUS SCREW AND SPIKED WASHER SYSTEM K994202 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Feb 2000. https://www.510kdatabase.net/k000210/ 2000-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k000210-modification-to-model-5866-37m-lead-fda-510k.jpg K000210 - MODIFICATION TO MODEL 5866-37M LEAD ADAPTOR KIT K000210 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Feb 2000. https://www.510kdatabase.net/k000257/ 2000-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k000257-immulite-2000-pap-models-l2kpa2-l2kpa6-fda-510k.jpg K000257 - IMMULITE 2000 PAP, MODELS L2KPA2, L2KPA6 K000257 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Feb 2000. https://www.510kdatabase.net/k000364/ 2000-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k000364-accu-chek-complete-meter-fda-510k.jpg K000364 - ACCU-CHEK COMPLETE METER K000364 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Feb 2000. https://www.510kdatabase.net/k000365/ 2000-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k000365-accu-chek-advantage-meter-fda-510k.jpg K000365 - ACCU-CHEK ADVANTAGE METER K000365 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Feb 2000. https://www.510kdatabase.net/k993974/ 2000-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k993974-siemens-infinity-sc-6002xl-portable-fda-510k.jpg K993974 - SIEMENS INFINITY SC 6002XL PORTABLE PATIENT MONITOR K993974 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 2000. https://www.510kdatabase.net/k000196/ 2000-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k000196-access-myoglobin-on-the-access-fda-510k.jpg K000196 - ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315, 33319, 33316 K000196 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Feb 2000. https://www.510kdatabase.net/k000362/ 2000-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k000362-modification-to-zeus-scientific-inc-fda-510k.jpg K000362 - MODIFICATION TO ZEUS SCIENTIFIC, INC., TPO IGG ELISA TEST SYSTEM K000362 is a FDA 510(k) cleared immunology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Feb 2000. https://www.510kdatabase.net/k000363/ 2000-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k000363-modification-to-zeus-scientific-inc-fda-510k.jpg K000363 - MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM K000363 is a FDA 510(k) cleared immunology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Feb 2000. https://www.510kdatabase.net/k994143/ 2000-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k994143-smith-nephew-external-fixation-system-fda-510k.jpg K994143 - SMITH & NEPHEW EXTERNAL FIXATION SYSTEM [UNILATERAL (LINEAR) & MULTILATERAL (CIRCULAR) FIXATORS AND ACCESSORIES] K994143 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Feb 2000. https://www.510kdatabase.net/k000242/ 2000-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k000242-acumatch-a-series-corundum-acetabular-fda-510k.jpg K000242 - ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT AND ACUMATCH A-SERIES CORUNDUM ACETABULAR COMPONENT WITH HYDROXYAPATITE K000242 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Feb 2000. https://www.510kdatabase.net/k000334/ 2000-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k000334-impact-modular-total-hip-system-fda-510k.jpg K000334 - IMPACT MODULAR TOTAL HIP SYSTEM K000334 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Feb 2000. https://www.510kdatabase.net/k000379/ 2000-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k000379-modofication-to-afffinity-38-micro-fda-510k.jpg K000379 - MODOFICATION TO AFFFINITY 38 MICRO ARTERIAL BLOOD FILTER WITH CARMEDA BIOACTIVE SURFACE, MODELS CB351/CB352 K000379 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Feb 2000. https://www.510kdatabase.net/k000310/ 2000-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k000310-voyager-60-software-option-fda-510k.jpg K000310 - VOYAGER 6.0 SOFTWARE OPTION K000310 is a FDA 510(k) cleared neurology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Feb 2000. https://www.510kdatabase.net/k994184/ 2000-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k994184-plr-splined-revision-stem-fda-510k.jpg K994184 - PLR SPLINED REVISION STEM K994184 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Feb 2000. https://www.510kdatabase.net/k000185/ 2000-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k000185-gore-tex-dualmesh-plus-biomaterial-1-fda-510k.jpg K000185 - GORE-TEX DUALMESH PLUS BIOMATERIAL (1 MM & 2MM) K000185 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Feb 2000. https://www.510kdatabase.net/k994061/ 2000-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k994061-locon-t-distal-radial-plate-fda-510k.jpg K994061 - LOCON-T DISTAL RADIAL PLATE K994061 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Feb 2000. https://www.510kdatabase.net/k983928/ 2000-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k983928-kodak-home-health-monitoring-system-fda-510k.jpg K983928 - KODAK HOME HEALTH MONITORING SYSTEM K983928 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Eastman Kodak Company. Cleared Feb 2000. https://www.510kdatabase.net/k993889/ 2000-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k993889-exeter-ceramic-femoral-heads-fda-510k.jpg K993889 - EXETER CERAMIC FEMORAL HEADS K993889 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Feb 2000. https://www.510kdatabase.net/k000331/ 2000-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k000331-synchron-lx-systems-microalbumin-fda-510k.jpg K000331 - SYNCHRON LX SYSTEMS MICROALBUMIN CALIBRATOR K000331 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Feb 2000. https://www.510kdatabase.net/k000094/ 2000-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k000094-modification-to-cd-horizon-spinal-system-fda-510k.jpg K000094 - MODIFICATION TO CD HORIZON SPINAL SYSTEM K000094 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medtronic Sofamor Danek USA, Inc.. Cleared Feb 2000. https://www.510kdatabase.net/k000254/ 2000-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k000254-par-5-acetabular-component-fda-510k.jpg K000254 - PAR 5 ACETABULAR COMPONENT K000254 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Feb 2000. https://www.510kdatabase.net/k993801/ 2000-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k993801-gynecare-laparoscopic-morcellator-fda-510k.jpg K993801 - GYNECARE LAPAROSCOPIC MORCELLATOR K993801 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ethicon, Inc.. Cleared Feb 2000. https://www.510kdatabase.net/k993804/ 2000-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k993804-ksea-rigid-culdoscope-and-accessories-fda-510k.jpg K993804 - KSEA RIGID CULDOSCOPE AND ACCESSORIES K993804 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Feb 2000. https://www.510kdatabase.net/k993972/ 2000-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k993972-disposable-infusion-pump-kit-fda-510k.jpg K993972 - DISPOSABLE INFUSION PUMP KIT K993972 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Biomet, Inc.. Cleared Feb 2000. https://www.510kdatabase.net/k000207/ 2000-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k000207-porocoat-prodigy-hip-prosthesis-fda-510k.jpg K000207 - POROCOAT PRODIGY HIP PROSTHESIS K000207 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Feb 2000. https://www.510kdatabase.net/k994007/ 2000-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k994007-malloryhead-smooth-femoral-component-fda-510k.jpg K994007 - MALLORY/HEAD SMOOTH FEMORAL COMPONENT K994007 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Feb 2000. https://www.510kdatabase.net/k994211/ 2000-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k994211-acucam-intraoral-camera-sheaths-models-fda-510k.jpg K994211 - ACUCAM INTRAORAL CAMERA SHEATHS, MODELS 023545, 601111, 300407, 601285 K994211 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Dentsply Intl.. Cleared Feb 2000. https://www.510kdatabase.net/k994294/ 2000-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k994294-dimension-trnf-flex-reagent-cartridge-fda-510k.jpg K994294 - DIMENSION TRNF FLEX REAGENT CARTRIDGE K994294 is a FDA 510(k) cleared immunology medical device. Manufacturer: Dade Behring, Inc.. Cleared Feb 2000. https://www.510kdatabase.net/k994315/ 2000-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k994315-cp-peripheral-angio-array-coil-fda-510k.jpg K994315 - CP PERIPHERAL ANGIO ARRAY COIL/ MAGNETOM SYMPHONY SYSTEM K994315 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 2000. https://www.510kdatabase.net/k000089/ 2000-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k000089-synthes-40-and-50-mm-locking-screws-fda-510k.jpg K000089 - SYNTHES 4.0 AND 5.0 MM LOCKING SCREWS K000089 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Feb 2000. https://www.510kdatabase.net/k000172/ 2000-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k000172-depuy-contour-unicompartmental-knee-fda-510k.jpg K000172 - DEPUY CONTOUR UNICOMPARTMENTAL KNEE PROSTHESIS K000172 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Feb 2000. https://www.510kdatabase.net/k994168/ 2000-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k994168-synchron-lx-systems-prealbumin-fda-510k.jpg K994168 - SYNCHRON LX SYSTEMS PREALBUMIN CALIBRATOR K994168 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Feb 2000. https://www.510kdatabase.net/k994169/ 2000-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k994169-synchron-cx-systems-prealbumin-fda-510k.jpg K994169 - SYNCHRON CX SYSTEMS PREALBUMIN CALIBRATOR K994169 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Feb 2000. https://www.510kdatabase.net/k994415/ 2000-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k994415-marathon-cross-linked-polyethylene-fda-510k.jpg K994415 - MARATHON CROSS-LINKED POLYETHYLENE ACETABULAR CUP LINERS K994415 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Feb 2000. https://www.510kdatabase.net/k993751/ 2000-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k993751-corometrics-model-173-fetal-monitor-fda-510k.jpg K993751 - COROMETRICS MODEL 173 FETAL MONITOR K993751 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Feb 2000. https://www.510kdatabase.net/k993547/ 2000-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k993547-beckman-coulter-immage-immunochemistry-fda-510k.jpg K993547 - BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN M (IGMLC) REAGENT, BECKMAN COULTER CEREB K993547 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Feb 2000. https://www.510kdatabase.net/k993549/ 2000-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k993549-beckman-coulter-immage-immunochemistry-fda-510k.jpg K993549 - BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN A (IGALC) REAGENT, BECKMAN COULTER CEREBR K993549 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Feb 2000. https://www.510kdatabase.net/k993980/ 2000-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k993980-syva-emit-ii-plus-ethyl-alcohol-assay-fda-510k.jpg K993980 - SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL K993980 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Feb 2000. https://www.510kdatabase.net/k993981/ 2000-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k993981-syva-emit-ii-plus-propoxyphene-assay-fda-510k.jpg K993981 - SYVA EMIT II PLUS PROPOXYPHENE ASSAY, MODELS 9G029UL/9G129UL K993981 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Feb 2000. https://www.510kdatabase.net/k993840/ 2000-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k993840-bard-uroforce-balloon-dilation-catheter-fda-510k.jpg K993840 - BARD UROFORCE BALLOON DILATION CATHETER K993840 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 2000. https://www.510kdatabase.net/k990340/ 2000-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k990340-arthrex-pla-tissuetak-model-ar-1940-bu-fda-510k.jpg K990340 - ARTHREX PLA TISSUETAK, MODEL # AR-1940 BU K990340 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jan 2000. https://www.510kdatabase.net/k991162/ 2000-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k991162-biolox-alumina-ceramic-femoral-head-fda-510k.jpg K991162 - BIOLOX ALUMINA CERAMIC FEMORAL HEAD K991162 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jan 2000. https://www.510kdatabase.net/k992957/ 2000-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k992957-advanced-d-dimer-fda-510k.jpg K992957 - ADVANCED D-DIMER K992957 is a FDA 510(k) cleared hematology medical device. Manufacturer: Dade Behring, Inc.. Cleared Jan 2000. https://www.510kdatabase.net/k994085/ 2000-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k994085-immulite-turbo-hcg-models-lskcg1-lskcg5-fda-510k.jpg K994085 - IMMULITE TURBO HCG, MODELS LSKCG1, LSKCG5 K994085 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jan 2000. https://www.510kdatabase.net/k994115/ 2000-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k994115-total-iron-binding-capacity-ibct-flex-fda-510k.jpg K994115 - TOTAL IRON BINDING CAPACITY (IBCT) FLEX REAGENT CARTRIDGE K994115 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Jan 2000. https://www.510kdatabase.net/k992632/ 2000-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k992632-immulite-amphetamine-models-lkam1-lkam5-fda-510k.jpg K992632 - IMMULITE AMPHETAMINE, MODELS LKAM1, LKAM5 K992632 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jan 2000. https://www.510kdatabase.net/k993026/ 2000-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k993026-abbot-aeroset-phenytoin-assay-abbot-fda-510k.jpg K993026 - ABBOT AEROSET PHENYTOIN ASSAY & ABBOT AEROSET PHENYTOIN CALIBRATORS K993026 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jan 2000. https://www.510kdatabase.net/k993028/ 2000-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k993028-abbott-aeroset-carbamazepine-assay-and-fda-510k.jpg K993028 - ABBOTT AEROSET CARBAMAZEPINE ASSAY AND CALIBRATORS K993028 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jan 2000. https://www.510kdatabase.net/k993029/ 2000-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k993029-abbott-aeroset-theophylline-assay-and-fda-510k.jpg K993029 - ABBOTT AEROSET THEOPHYLLINE ASSAY AND CALIBRATORS K993029 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jan 2000. https://www.510kdatabase.net/k993031/ 2000-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k993031-abbott-aeroset-phenobarbital-assey-and-fda-510k.jpg K993031 - ABBOTT AEROSET PHENOBARBITAL ASSEY AND CALIBRATORS K993031 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jan 2000. https://www.510kdatabase.net/k993982/ 2000-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k993982-syva-emit-ii-plus-amphetaminemethampheta-fda-510k.jpg K993982 - SYVA EMIT II PLUS AMPHETAMINE/METHAMPHETAMINE ASSAY 9C029UL/9C129UL K993982 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jan 2000. https://www.510kdatabase.net/k993983/ 2000-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k993983-syva-emit-ii-plus-phencyclidine-assay-fda-510k.jpg K993983 - SYVA EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL 9J029UL K993983 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jan 2000. https://www.510kdatabase.net/k993985/ 2000-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k993985-syva-emit-ii-plus-benzodiazepine-assay-fda-510k.jpg K993985 - SYVA EMIT II PLUS BENZODIAZEPINE ASSAY, MODELS 9F029UL/9F129UL K993985 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jan 2000. https://www.510kdatabase.net/k993986/ 2000-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k993986-syva-emit-ii-plus-methaqualone-assay-fda-510k.jpg K993986 - SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129UL K993986 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jan 2000. https://www.510kdatabase.net/k993987/ 2000-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k993987-syva-emit-ii-plus-barbiturate-assay-fda-510k.jpg K993987 - SYVA EMIT II PLUS BARBITURATE ASSAY, MODEL 9D029UL/9D129UL K993987 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jan 2000. https://www.510kdatabase.net/k993988/ 2000-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k993988-syva-emit-ii-plus-cocaine-metabolite-fda-510k.jpg K993988 - SYVA EMIT II PLUS COCAINE METABOLITE ASSAY, MODEL 9H029UL K993988 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jan 2000. https://www.510kdatabase.net/k994004/ 2000-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k994004-quanta-lite-lyme-b-burgdorferi-iggigm-fda-510k.jpg K994004 - QUANTA LITE LYME B. BURGDORFERI IGG/IGM ELISA KIT K994004 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Jan 2000. https://www.510kdatabase.net/k994017/ 2000-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k994017-ontrak-testcup-5-m2k-cat-11-1850-1-fda-510k.jpg K994017 - ONTRAK TESTCUP 5 M2K, CAT. 11 1850 1 K994017 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jan 2000. https://www.510kdatabase.net/k994020/ 2000-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k994020-ontrak-teststik-for-pcp-cat-07-6654-2-fda-510k.jpg K994020 - ONTRAK TESTSTIK FOR PCP, CAT. 07 6654 2 K994020 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jan 2000. https://www.510kdatabase.net/k994030/ 2000-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k994030-ontrak-testcup-5-cat-07-6481-7-fda-510k.jpg K994030 - ONTRAK TESTCUP 5, CAT. 07 6481 7 K994030 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jan 2000. https://www.510kdatabase.net/k994418/ 2000-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k994418-versapoint-electrosurgery-system-scuba-fda-510k.jpg K994418 - VERSAPOINT ELECTROSURGERY SYSTEM (SCUBA) K994418 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ethicon, Inc.. Cleared Jan 2000. https://www.510kdatabase.net/k993768/ 2000-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k993768-citation-tmzf-ha-stem-fda-510k.jpg K993768 - CITATION TMZF HA STEM K993768 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jan 2000. https://www.510kdatabase.net/k994331/ 2000-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k994331-reveal-plus-insertable-loop-recorder-fda-510k.jpg K994331 - REVEAL PLUS INSERTABLE LOOP RECORDER SYSTEM, MODEL 9526 IMPLANTED RECORDER AND MODEL 6191 PATIENT ACTIVATOR K994331 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jan 2000. https://www.510kdatabase.net/k992634/ 2000-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k992634-immulite-methamphetamine-model-lkma1-fda-510k.jpg K992634 - IMMULITE METHAMPHETAMINE, MODEL LKMA1, LKMA5 K992634 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jan 2000. https://www.510kdatabase.net/k993587/ 2000-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k993587-hp-m2376a-device-link-system-fda-510k.jpg K993587 - HP M2376A DEVICE LINK SYSTEM K993587 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Jan 2000. https://www.510kdatabase.net/k993736/ 2000-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k993736-exactech-acumatch-integrated-hip-fda-510k.jpg K993736 - EXACTECH ACUMATCH INTEGRATED HIP SYSTEM M-SERIES FEMORAL STEM COMPONENT K993736 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Jan 2000. https://www.510kdatabase.net/k994005/ 2000-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k994005-syva-emit-ii-plus-methadone-assay-fda-510k.jpg K994005 - SYVA EMIT II PLUS METHADONE ASSAY, MODELS 9E029UL/9E129UL K994005 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Jan 2000. https://www.510kdatabase.net/k994084/ 2000-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k994084-smith-nephew-xenon-light-sources-and-fda-510k.jpg K994084 - SMITH & NEPHEW XENON LIGHT SOURCES AND ACCESSORIES K994084 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jan 2000. https://www.510kdatabase.net/k994114/ 2000-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k994114-dimension-total-iron-binding-capacity-fda-510k.jpg K994114 - DIMENSION TOTAL IRON BINDING CAPACITY (IBCT) CALIBRATOR K994114 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Jan 2000. https://www.510kdatabase.net/k993720/ 2000-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k993720-cordis-maxi-ld-large-diameter-balloon-fda-510k.jpg K993720 - CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER K993720 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Jan 2000. https://www.510kdatabase.net/k993984/ 2000-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k993984-syva-emit-ii-plus-cannabinoid-assay-fda-510k.jpg K993984 - SYVA EMIT II PLUS CANNABINOID ASSAY, MODELS 9N029UL/9N129UL K993984 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jan 2000. https://www.510kdatabase.net/k994200/ 2000-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k994200-access-hybritech-psa-qc-model-37209-fda-510k.jpg K994200 - ACCESS HYBRITECH PSA QC, MODEL 37209 K994200 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jan 2000. https://www.510kdatabase.net/k992851/ 2000-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k992851-act-test-catridges-for-coaguchek-pro-fda-510k.jpg K992851 - ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM K992851 is a FDA 510(k) cleared hematology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jan 2000. https://www.510kdatabase.net/k994277/ 2000-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k994277-access-ostase-qc-fda-510k.jpg K994277 - ACCESS OSTASE QC K994277 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jan 2000. https://www.510kdatabase.net/k994439/ 2000-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k994439-access-ck-mb-on-the-access-immunoassay-fda-510k.jpg K994439 - ACCESS CK-MB ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33300, 33305, 33309, 33306 K994439 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jan 2000. https://www.510kdatabase.net/k990987/ 2000-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k990987-bio-absorbable-corkscrew-model-ar-1920b-fda-510k.jpg K990987 - BIO-ABSORBABLE CORKSCREW, MODEL AR-1920B K990987 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jan 2000. https://www.510kdatabase.net/k992053/ 2000-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k992053-aesculap-vascular-instruments-fda-510k.jpg K992053 - AESCULAP VASCULAR INSTRUMENTS K992053 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Aesculap, Inc.. Cleared Jan 2000. https://www.510kdatabase.net/k993531/ 2000-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k993531-passport-2-vital-signs-monitor-model-fda-510k.jpg K993531 - PASSPORT 2 VITAL SIGNS MONITOR, MODEL 0998-00-0170-XX K993531 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Jan 2000. https://www.510kdatabase.net/k993551/ 2000-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k993551-socon-spinal-system-fda-510k.jpg K993551 - SOCON SPINAL SYSTEM K993551 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aesculap, Inc.. Cleared Jan 2000. https://www.510kdatabase.net/k994358/ 2000-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k994358-atw-marker-wire-steerable-guidewire-fda-510k.jpg K994358 - ATW MARKER WIRE STEERABLE GUIDEWIRE K994358 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Jan 2000. https://www.510kdatabase.net/k992116/ 2000-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k992116-siememns-infinity-etc02-pod-fda-510k.jpg K992116 - SIEMEMNS INFINITY ETC02 POD K992116 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 2000. https://www.510kdatabase.net/k994325/ 2000-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k994325-synchron-cx-systems-microalbumin-fda-510k.jpg K994325 - SYNCHRON CX SYSTEMS MICROALBUMIN CALIBRATOR K994325 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jan 2000. https://www.510kdatabase.net/k992489/ 2000-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k992489-3m-tr-system-fda-510k.jpg K992489 - 3M TR SYSTEM K992489 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Jan 2000. https://www.510kdatabase.net/k992959/ 2000-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k992959-behring-coagulation-system-bcs-fda-510k.jpg K992959 - BEHRING COAGULATION SYSTEM (BCS) K992959 is a FDA 510(k) cleared hematology medical device. Manufacturer: Dade Behring, Inc.. Cleared Jan 2000. https://www.510kdatabase.net/k993455/ 2000-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k993455-flipper-detachable-embolization-coil-fda-510k.jpg K993455 - FLIPPER DETACHABLE EMBOLIZATION COIL K993455 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Jan 2000. https://www.510kdatabase.net/k993465/ 2000-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k993465-depuy-ace-calcaneal-peri-articular-plate-fda-510k.jpg K993465 - DEPUY ACE CALCANEAL PERI-ARTICULAR PLATE K993465 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jan 2000. https://www.510kdatabase.net/k993954/ 2000-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k993954-synchron-systems-dat-multi-drug-low-fda-510k.jpg K993954 - SYNCHRON SYSTEMS DAT MULTI-DRUG LOW AND HIGH URINE CALIBRATORS K993954 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jan 2000. https://www.510kdatabase.net/k992455/ 2000-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k992455-nihon-kohden-ogs-2001a-pocketcare-and-fda-510k.jpg K992455 - NIHON KOHDEN OGS-2001A POCKETCARE AND ACCESSORIES K992455 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Jan 2000. https://www.510kdatabase.net/k994156/ 2000-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k994156-modification-to-cordis-palmaz-fda-510k.jpg K994156 - MODIFICATION TO CORDIS PALMAZ CORINTHIAN IQ TRANSHEPATIC BILIARY STENT, MODELS PQ294B, PQ394B K994156 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Jan 2000. https://www.510kdatabase.net/k993392/ 2000-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k993392-bard-memotherm-flexx-biliary-stent-fda-510k.jpg K993392 - BARD MEMOTHERM FLEXX BILIARY STENT K993392 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 2000. https://www.510kdatabase.net/k993892/ 2000-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k993892-duraglide-stone-removal-balloon-model-fda-510k.jpg K993892 - DURAGLIDE STONE REMOVAL BALLOON, MODEL 000635-38, 000646-47, DURAGLIDE STONE BALLOON, MODEL 007124-25,007144-45 K993892 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 2000. https://www.510kdatabase.net/k993210/ 2000-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k993210-access-hybritech-free-psa-qc-model-37219-fda-510k.jpg K993210 - ACCESS HYBRITECH FREE PSA QC, MODEL 37219 K993210 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jan 2000. https://www.510kdatabase.net/k994253/ 2000-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k994253-vaclok-syringe-fda-510k.jpg K994253 - VACLOK SYRINGE K994253 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jan 2000. https://www.510kdatabase.net/k994252/ 2000-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k994252-introducer-sheaths-vessel-dilator-fda-510k.jpg K994252 - INTRODUCER SHEATHS, VESSEL DILATOR, GUIDEWIRE K994252 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Jan 2000. https://www.510kdatabase.net/k993731/ 1999-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k993731-sonata-gradientsmagnetom-symphony-system-fda-510k.jpg K993731 - SONATA GRADIENTS/MAGNETOM SYMPHONY SYSTEM K993731 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Dec 1999. https://www.510kdatabase.net/k994068/ 1999-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k994068-smart-nitinol-stent-transhepatic-fda-510k.jpg K994068 - S.M.A.R.T. NITINOL STENT TRANSHEPATIC BILIARY SYSTEM K994068 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Dec 1999. https://www.510kdatabase.net/k993932/ 1999-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k993932-solitaire-2-fda-510k.jpg K993932 - SOLITAIRE 2 K993932 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Dec 1999. https://www.510kdatabase.net/k994038/ 1999-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k994038-modular-reach-hip-fda-510k.jpg K994038 - MODULAR REACH HIP K994038 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Dec 1999. https://www.510kdatabase.net/k994039/ 1999-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k994039-abbott-gemstar-iv-infusion-pump-7-fda-510k.jpg K994039 - ABBOTT GEMSTAR I.V. INFUSION PUMP-7 THERAPY CONFIGURATION, ABBOTT GEMSTAR I.V. INFUSION PUMP-6 THERAPY CONFIGURATION, AB K994039 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Dec 1999. https://www.510kdatabase.net/k993107/ 1999-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k993107-bio-rad-homocysteine-by-hplc-fda-510k.jpg K993107 - BIO-RAD HOMOCYSTEINE BY HPLC K993107 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bio-Rad. Cleared Dec 1999. https://www.510kdatabase.net/k993755/ 1999-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k993755-emit-calibratercontrol-level-0-level-1-fda-510k.jpg K993755 - EMIT CALIBRATER/CONTROL LEVEL 0, LEVEL 1, LEVEL 2, LEVEL 3, LEVEL 4, LEVEL 5 K993755 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Dec 1999. https://www.510kdatabase.net/k994187/ 1999-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k994187-synthes-cervifix-system-fda-510k.jpg K994187 - SYNTHES CERVIFIX SYSTEM K994187 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Dec 1999. https://www.510kdatabase.net/k990849/ 1999-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k990849-duration-iv-sterilization-process-fda-510k.jpg K990849 - DURATION IV STERILIZATION PROCESS (ACETABULAR INSERTS) K990849 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Dec 1999. https://www.510kdatabase.net/k992121/ 1999-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k992121-embolization-coil-system-fda-510k.jpg K992121 - EMBOLIZATION COIL SYSTEM K992121 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Dec 1999. https://www.510kdatabase.net/k992355/ 1999-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k992355-lactosorb-trauma-plating-system-fda-510k.jpg K992355 - LACTOSORB TRAUMA PLATING SYSTEM K992355 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Dec 1999. https://www.510kdatabase.net/k993048/ 1999-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k993048-roche-diagnostics-influenza-ab-rapid-fda-510k.jpg K993048 - ROCHE DIAGNOSTICS INFLUENZA A/B RAPID TEST K993048 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Dec 1999. https://www.510kdatabase.net/k993169/ 1999-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k993169-modification-of-physiological-signal-fda-510k.jpg K993169 - MODIFICATION OF: PHYSIOLOGICAL SIGNAL TRANSMITTER AND RECEIVER, MODEL 3810A K993169 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Dec 1999. https://www.510kdatabase.net/k993289/ 1999-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k993289-smith-nephew-compression-hip-screw-fda-510k.jpg K993289 - SMITH & NEPHEW COMPRESSION HIP SCREW SYSTEM, INTRAMEDULLARY HIP SCREW SYSTEM K993289 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Dec 1999. https://www.510kdatabase.net/k993371/ 1999-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k993371-saddle-shaped-patella-fda-510k.jpg K993371 - SADDLE SHAPED PATELLA K993371 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Dec 1999. https://www.510kdatabase.net/k993402/ 1999-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k993402-opus-spinal-system-fda-510k.jpg K993402 - OPUS SPINAL SYSTEM K993402 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Dec 1999. https://www.510kdatabase.net/k993956/ 1999-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k993956-titanium-pediatric-femoral-nail-fda-510k.jpg K993956 - TITANIUM PEDIATRIC FEMORAL NAIL K993956 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Dec 1999. https://www.510kdatabase.net/k993952/ 1999-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k993952-immulite-2000-cmv-igg-model-l2kcv2-fda-510k.jpg K993952 - IMMULITE 2000 CMV IGG, MODEL L2KCV2, L2KCV6 K993952 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Dec 1999. https://www.510kdatabase.net/k993539/ 1999-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k993539-dci-endoscope-fda-510k.jpg K993539 - DCI ENDOSCOPE K993539 is a FDA 510(k) cleared neurology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Dec 1999. https://www.510kdatabase.net/k993602/ 1999-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k993602-pre-vision-fill-fda-510k.jpg K993602 - PRE-VISION FILL K993602 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Dec 1999. https://www.510kdatabase.net/k993103/ 1999-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k993103-endoscopes10mm-diameter-0-degrees-fda-510k.jpg K993103 - ENDOSCOPES,10MM DIAMETER 0 DEGREES K993103 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Dec 1999. https://www.510kdatabase.net/k993464/ 1999-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k993464-bardex-ic-pediatric-foley-catheter-fda-510k.jpg K993464 - BARDEX I.C. PEDIATRIC FOLEY CATHETER K993464 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 1999. https://www.510kdatabase.net/k993106/ 1999-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k993106-smith-nephew-bone-plate-system-bone-fda-510k.jpg K993106 - SMITH & NEPHEW BONE PLATE SYSTEM (BONE PLATES, BONE SCREWS AND ACCESSORIES) K993106 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Dec 1999. https://www.510kdatabase.net/k993829/ 1999-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k993829-accu-chek-simplicity-system-fda-510k.jpg K993829 - ACCU-CHEK SIMPLICITY SYSTEM K993829 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Dec 1999. https://www.510kdatabase.net/k993299/ 1999-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k993299-sysmex-automated-coagulation-analyzer-fda-510k.jpg K993299 - SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500 K993299 is a FDA 510(k) cleared hematology medical device. Manufacturer: Dade Behring, Inc.. Cleared Dec 1999. https://www.510kdatabase.net/k992711/ 1999-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k992711-sigma-diagnostics-alexin-hs-models-fda-510k.jpg K992711 - SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094 K992711 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Dec 1999. https://www.510kdatabase.net/k992712/ 1999-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k992712-sigma-diagnostics-alexin-ls-models-fda-510k.jpg K992712 - SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334 K992712 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Dec 1999. https://www.510kdatabase.net/k993314/ 1999-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k993314-synthes-light-guide-fda-510k.jpg K993314 - SYNTHES LIGHT GUIDE K993314 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Synthes (Usa). Cleared Dec 1999. https://www.510kdatabase.net/k992992/ 1999-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k992992-automatic-image-registration-software-fda-510k.jpg K992992 - AUTOMATIC IMAGE REGISTRATION SOFTWARE, MODEL NSFU-050A K992992 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Dec 1999. https://www.510kdatabase.net/k993692/ 1999-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k993692-duracon-inset-patella-25mm-fda-510k.jpg K993692 - DURACON INSET PATELLA, 25MM K993692 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Dec 1999. https://www.510kdatabase.net/k992977/ 1999-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k992977-hewlett-packard-multifunction-fda-510k.jpg K992977 - HEWLETT PACKARD MULTIFUNCTION PEDIATRIC DEFIB FUNCTION, MODEL M3503A & M3504A K992977 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Dec 1999. https://www.510kdatabase.net/k993310/ 1999-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k993310-apolipoprotein-control-serum-chd-model-fda-510k.jpg K993310 - APOLIPOPROTEIN CONTROL SERUM CHD, MODEL OUPH K993310 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Nov 1999. https://www.510kdatabase.net/k993642/ 1999-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k993642-elecsys-parathyroid-hormone-calcheck-fda-510k.jpg K993642 - ELECSYS PARATHYROID HORMONE CALCHECK K993642 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Nov 1999. https://www.510kdatabase.net/k993646/ 1999-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k993646-smart-018-nitinol-stent-transhepatic-fda-510k.jpg K993646 - S.M.A.R.T. .018 NITINOL STENT TRANSHEPATIC BILIARY SYSTEM K993646 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Nov 1999. https://www.510kdatabase.net/k993023/ 1999-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k993023-synchron-systems-op-300-low-and-high-fda-510k.jpg K993023 - SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CONTROLS K993023 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Nov 1999. https://www.510kdatabase.net/k993425/ 1999-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k993425-primus-fda-510k.jpg K993425 - PRIMUS K993425 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 1999. https://www.510kdatabase.net/k993473/ 1999-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k993473-synchron-systems-drug-calibrator-2-fda-510k.jpg K993473 - SYNCHRON SYSTEMS DRUG CALIBRATOR 2 K993473 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Nov 1999. https://www.510kdatabase.net/k992710/ 1999-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k992710-abbott-architech-glycated-hemoglobin-fda-510k.jpg K992710 - ABBOTT ARCHITECH GLYCATED HEMOGLOBIN MASTERCHECK K992710 is a FDA 510(k) cleared immunology medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1999. https://www.510kdatabase.net/k992834/ 1999-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k992834-gem-premier-3000-fda-510k.jpg K992834 - GEM PREMIER 3000 K992834 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Nov 1999. https://www.510kdatabase.net/k992894/ 1999-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k992894-meridian-hemodialysis-machine-model-fda-510k.jpg K992894 - MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576 K992894 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Nov 1999. https://www.510kdatabase.net/k992900/ 1999-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k992900-precinorm-universal-and-precipath-fda-510k.jpg K992900 - PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA K992900 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Nov 1999. https://www.510kdatabase.net/k993360/ 1999-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k993360-precinorm-universal-plus-and-precipath-fda-510k.jpg K993360 - PRECINORM UNIVERSAL PLUS AND PRECIPATH UNIVERSAL PLUS CONTROL SERA K993360 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Nov 1999. https://www.510kdatabase.net/k991906/ 1999-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k991906-laparo-co2-pneu-automatic-insufflator-fda-510k.jpg K991906 - LAPARO CO2-PNEU AUTOMATIC INSUFFLATOR WITH 30L FLOW RATE,AND VIDEO-SCREEN DISPLAY, HIGH FLOW INSUFFLATION TUBE WITH HEAT K991906 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Nov 1999. https://www.510kdatabase.net/k992890/ 1999-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k992890-roche-cobas-integra-opiates-3002000-fda-510k.jpg K992890 - ROCHE COBAS INTEGRA OPIATES 300/2000 K992890 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Nov 1999. https://www.510kdatabase.net/k993273/ 1999-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k993273-n-latex-ferritin-fda-510k.jpg K993273 - N LATEX FERRITIN K993273 is a FDA 510(k) cleared immunology medical device. Manufacturer: Dade Behring, Inc.. Cleared Nov 1999. https://www.510kdatabase.net/k993540/ 1999-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k993540-endospine-operating-tube-and-telescope-fda-510k.jpg K993540 - ENDOSPINE OPERATING TUBE AND TELESCOPE BRIDGE K993540 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Nov 1999. https://www.510kdatabase.net/k993082/ 1999-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k993082-exactech-acumatch-integrated-hip-fda-510k.jpg K993082 - EXACTECH ACUMATCH INTEGRATED HIP SYSTEM A-SERIES POROUS COATED ACETABULAR COMPONENT K993082 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Nov 1999. https://www.510kdatabase.net/k993352/ 1999-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k993352-crossfire-system-12-acetabular-inserts-fda-510k.jpg K993352 - CROSSFIRE SYSTEM 12 ACETABULAR INSERTS K993352 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Nov 1999. https://www.510kdatabase.net/k993603/ 1999-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k993603-wichita-fusion-nail-fully-threaded-fda-510k.jpg K993603 - WICHITA FUSION NAIL FULLY THREADED SELF-TAPPING SCREW K993603 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Nov 1999. https://www.510kdatabase.net/k990290/ 1999-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k990290-craniofacial-calcium-phosphate-ceramic-fda-510k.jpg K990290 - CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLER K990290 is a FDA 510(k) cleared neurology medical device. Manufacturer: Biomet, Inc.. Cleared Nov 1999. https://www.510kdatabase.net/k992510/ 1999-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k992510-wallstent-tracheobronchial-fda-510k.jpg K992510 - WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM K992510 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Boston Scientific Corp. Cleared Nov 1999. https://www.510kdatabase.net/k992945/ 1999-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k992945-rci-fixation-screws-with-assorted-sizes-fda-510k.jpg K992945 - RCI FIXATION SCREWS (WITH ASSORTED SIZES) K992945 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Nov 1999. https://www.510kdatabase.net/k992822/ 1999-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k992822-seal-protect-protective-sealant-for-fda-510k.jpg K992822 - SEAL & PROTECT PROTECTIVE SEALANT FOR EXPOSED DENTINE K992822 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Nov 1999. https://www.510kdatabase.net/k993120/ 1999-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k993120-modified-blood-recipient-set-fda-510k.jpg K993120 - MODIFIED BLOOD RECIPIENT SET K993120 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Nov 1999. https://www.510kdatabase.net/k993251/ 1999-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k993251-immulite-2000-vitamin-b12-model-l2kvb2-fda-510k.jpg K993251 - IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6 K993251 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Nov 1999. https://www.510kdatabase.net/k992287/ 1999-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k992287-first-step-unicompartmental-knee-system-fda-510k.jpg K992287 - FIRST STEP UNICOMPARTMENTAL KNEE SYSTEM K992287 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Nov 1999. https://www.510kdatabase.net/k992792/ 1999-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k992792-xia-spinal-system-c-c-adaptor-fda-510k.jpg K992792 - XIA SPINAL SYSTEM C-C ADAPTOR K992792 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Nov 1999. https://www.510kdatabase.net/k993510/ 1999-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k993510-modified-bmp-trochanteric-plates-fda-510k.jpg K993510 - MODIFIED BMP TROCHANTERIC PLATES K993510 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Nov 1999. https://www.510kdatabase.net/k993601/ 1999-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k993601-howmedica-osteonics-femoral-heads-fda-510k.jpg K993601 - HOWMEDICA OSTEONICS FEMORAL HEADS K993601 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Nov 1999. https://www.510kdatabase.net/k993670/ 1999-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k993670-modified-long-length-gamma-nail-fda-510k.jpg K993670 - MODIFIED LONG LENGTH GAMMA NAIL K993670 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Nov 1999. https://www.510kdatabase.net/k992777/ 1999-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k992777-constellation-catheters-model-8039-fda-510k.jpg K992777 - CONSTELLATION CATHETERS, MODEL 8039 K992777 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Nov 1999. https://www.510kdatabase.net/k993250/ 1999-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k993250-the-aptus-automated-application-of-the-fda-510k.jpg K993250 - THE APTUS (AUTOMATED) APPLICATION OF THE GLIADIN IGG ELISA TEST SYSTEM. K993250 is a FDA 510(k) cleared immunology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Nov 1999. https://www.510kdatabase.net/k993254/ 1999-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k993254-immulite-2000-folic-acid-model-l2kf02-fda-510k.jpg K993254 - IMMULITE 2000 FOLIC ACID, MODEL L2KF02, L2KF06 K993254 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Nov 1999. https://www.510kdatabase.net/k992731/ 1999-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k992731-ecam-computer-fda-510k.jpg K992731 - E.CAM COMPUTER K992731 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 1999. https://www.510kdatabase.net/k992969/ 1999-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k992969-respironics-total-face-mask-fda-510k.jpg K992969 - RESPIRONICS TOTAL FACE MASK K992969 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Nov 1999. https://www.510kdatabase.net/k992741/ 1999-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k992741-lyphochek-anemia-control-model-500-fda-510k.jpg K992741 - LYPHOCHEK ANEMIA CONTROL, MODEL 500 K992741 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Nov 1999. https://www.510kdatabase.net/k992886/ 1999-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k992886-powerview-ultrasound-workstation-uidm-fda-510k.jpg K992886 - POWERVIEW ULTRASOUND WORKSTATION, UIDM-400A K992886 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Nov 1999. https://www.510kdatabase.net/k993022/ 1999-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k993022-synchron-systems-op-300-low-and-high-fda-510k.jpg K993022 - SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CALIBRATORS K993022 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Nov 1999. https://www.510kdatabase.net/k993174/ 1999-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k993174-sysmex-automated-coagulation-analyzer-fda-510k.jpg K993174 - SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000 K993174 is a FDA 510(k) cleared hematology medical device. Manufacturer: Dade Behring, Inc.. Cleared Nov 1999. https://www.510kdatabase.net/k993516/ 1999-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k993516-hp-m2600a-viridia-telemetry-system-fda-510k.jpg K993516 - HP M2600A VIRIDIA TELEMETRY SYSTEM K993516 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Nov 1999. https://www.510kdatabase.net/k992373/ 1999-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k992373-orbiter-st-diagnostic-electrode-fda-510k.jpg K992373 - ORBITER ST DIAGNOSTIC ELECTRODE CATHETER & ORBITER ST EXTENSION CABLE K992373 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 1999. https://www.510kdatabase.net/k992656/ 1999-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k992656-depuy-total-elbow-system-fda-510k.jpg K992656 - DEPUY TOTAL ELBOW SYSTEM K992656 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Nov 1999. https://www.510kdatabase.net/k992660/ 1999-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k992660-urf-digital-ot-fda-510k.jpg K992660 - URF DIGITAL - OT K992660 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 1999. https://www.510kdatabase.net/k993536/ 1999-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k993536-bio-rad-coda-neonatal-galt-assay-fda-510k.jpg K993536 - BIO-RAD CODA NEONATAL GALT ASSAY K993536 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Nov 1999. https://www.510kdatabase.net/k991672/ 1999-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k991672-olympus-na-10j-kb-aspiration-needle-fda-510k.jpg K991672 - OLYMPUS NA-10J-KB ASPIRATION NEEDLE K991672 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus America, Inc.. Cleared Nov 1999. https://www.510kdatabase.net/k991884/ 1999-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k991884-siemens-fio2-sensor-fda-510k.jpg K991884 - SIEMENS FIO2 SENSOR K991884 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 1999. https://www.510kdatabase.net/k993186/ 1999-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k993186-synercid-15-ug-bbl-sensi-disc-fda-510k.jpg K993186 - SYNERCID, 15 UG, BBL SENSI-DISC K993186 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Nov 1999. https://www.510kdatabase.net/k991592/ 1999-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k991592-ksea-de-la-plaza-blepharoplasty-set-fda-510k.jpg K991592 - KSEA DE LA PLAZA BLEPHAROPLASTY SET K991592 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Nov 1999. https://www.510kdatabase.net/k992492/ 1999-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k992492-ptn-test-cartridges-for-coaguchek-pro-fda-510k.jpg K992492 - PTN TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, PTN CONTROLS FOR COAGUCHEK PRO SYSTEM K992492 is a FDA 510(k) cleared hematology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Nov 1999. https://www.510kdatabase.net/k992891/ 1999-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k992891-synthes-cerclage-positioning-pin-fda-510k.jpg K992891 - SYNTHES CERCLAGE POSITIONING PIN K992891 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Nov 1999. https://www.510kdatabase.net/k993000/ 1999-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k993000-bard-hydrophilic-coated-guide-wires-fda-510k.jpg K993000 - BARD HYDROPHILIC COATED GUIDE WIRES K993000 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 1999. https://www.510kdatabase.net/k990826/ 1999-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k990826-interactive-mr-localizer-magnetom-open-fda-510k.jpg K990826 - INTERACTIVE MR LOCALIZER/ MAGNETOM OPEN AND OPEN VIVA SYSTEM K990826 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 1999. https://www.510kdatabase.net/k991483/ 1999-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k991483-abbott-architect-glycated-hemoglobin-fda-510k.jpg K991483 - ABBOTT ARCHITECT GLYCATED HEMOGLOBIN K991483 is a FDA 510(k) cleared hematology medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1999. https://www.510kdatabase.net/k992704/ 1999-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k992704-il-test-von-willebrand-factor-fda-510k.jpg K992704 - IL TEST VON WILLEBRAND FACTOR K992704 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Nov 1999. https://www.510kdatabase.net/k993387/ 1999-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k993387-ipump-pain-management-system-model-fda-510k.jpg K993387 - IPUMP PAIN MANAGEMENT SYSTEM, MODEL 2L3107K K993387 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Nov 1999. https://www.510kdatabase.net/k993091/ 1999-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k993091-palmaz-xl-tanshepatic-biliary-stents-fda-510k.jpg K993091 - PALMAZ XL TANSHEPATIC BILIARY STENTS K993091 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Oct 1999. https://www.510kdatabase.net/k992667/ 1999-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k992667-zmr-hip-system-revision-taper-fda-510k.jpg K992667 - ZMR HIP SYSTEM-REVISION TAPER K992667 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Oct 1999. https://www.510kdatabase.net/k992784/ 1999-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k992784-next-generation-rodding-system-fda-510k.jpg K992784 - NEXT GENERATION RODDING SYSTEM K992784 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Oct 1999. https://www.510kdatabase.net/k993307/ 1999-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k993307-aria-lx-cpap-system-fda-510k.jpg K993307 - ARIA LX CPAP SYSTEM K993307 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Oct 1999. https://www.510kdatabase.net/k993433/ 1999-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k993433-virtuoso-lx-smart-cpap-system-fda-510k.jpg K993433 - VIRTUOSO LX SMART CPAP SYSTEM K993433 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Oct 1999. https://www.510kdatabase.net/k990397/ 1999-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k990397-flexible-fiberscopes-accessories-fda-510k.jpg K990397 - FLEXIBLE FIBERSCOPES & ACCESSORIES K990397 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Oct 1999. https://www.510kdatabase.net/k991385/ 1999-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k991385-dade-behring-n-high-sensitivity-crp-fda-510k.jpg K991385 - DADE BEHRING N HIGH SENSITIVITY CRP ASSAY K991385 is a FDA 510(k) cleared immunology medical device. Manufacturer: Dade Behring, Inc.. Cleared Oct 1999. https://www.510kdatabase.net/k992837/ 1999-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k992837-35-mm-90-cannulated-limited-contact-fda-510k.jpg K992837 - 3.5 MM 90 CANNULATED LIMITED CONTACT ANGELED BLADE PLATES (3.5MM 90 CANNULATED LC-ABP) K992837 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Oct 1999. https://www.510kdatabase.net/k992858/ 1999-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k992858-abbott-axsym-homocysteine-fda-510k.jpg K992858 - ABBOTT AXSYM HOMOCYSTEINE K992858 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1999. https://www.510kdatabase.net/k993341/ 1999-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k993341-intellisystem-ii-color-monitor-fda-510k.jpg K993341 - INTELLISYSTEM II COLOR MONITOR K993341 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Oct 1999. https://www.510kdatabase.net/k990637/ 1999-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k990637-synthes-locking-reconstruction-plate-fda-510k.jpg K990637 - SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEAD K990637 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Oct 1999. https://www.510kdatabase.net/k991026/ 1999-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k991026-reflection-crosslinked-uhmwpe-fda-510k.jpg K991026 - REFLECTION CROSSLINKED UHMWPE ACETABULAR COMPONENTS K991026 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 1999. https://www.510kdatabase.net/k992519/ 1999-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k992519-nrc-non-rinse-conditioner-fda-510k.jpg K992519 - NRC NON-RINSE CONDITIONER K992519 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Oct 1999. https://www.510kdatabase.net/k993181/ 1999-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k993181-howmedica-osteonics-accp-system-fda-510k.jpg K993181 - HOWMEDICA OSTEONICS ACCP SYSTEM CORTICAL SCREWS K993181 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Oct 1999. https://www.510kdatabase.net/k992899/ 1999-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k992899-bio-modular-shoulder-offset-humeral-fda-510k.jpg K992899 - BIO-MODULAR SHOULDER OFFSET HUMERAL HEADS K992899 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Oct 1999. https://www.510kdatabase.net/k993171/ 1999-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k993171-hp-viridia-information-system-models-fda-510k.jpg K993171 - HP VIRIDIA INFORMATION SYSTEM, MODELS M3150A/ M3151A/ M3153A/ M3154A K993171 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Oct 1999. https://www.510kdatabase.net/k992971/ 1999-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k992971-rep-cholesterol-profile-kit-fda-510k.jpg K992971 - REP CHOLESTEROL PROFILE KIT K992971 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Oct 1999. https://www.510kdatabase.net/k992591/ 1999-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k992591-codman-single-and-double-lumen-skull-fda-510k.jpg K992591 - CODMAN SINGLE AND DOUBLE LUMEN SKULL BOLT KITS K992591 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Oct 1999. https://www.510kdatabase.net/k992742/ 1999-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k992742-neurofax-model-eeg-1100a-fda-510k.jpg K992742 - NEUROFAX, MODEL EEG-1100A K992742 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Oct 1999. https://www.510kdatabase.net/k992985/ 1999-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k992985-gluma-comfort-bond-fda-510k.jpg K992985 - GLUMA COMFORT BOND K992985 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Oct 1999. https://www.510kdatabase.net/k993159/ 1999-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k993159-maxim-knee-system-fda-510k.jpg K993159 - MAXIM KNEE SYSTEM K993159 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Oct 1999. https://www.510kdatabase.net/k992673/ 1999-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k992673-vista-brite-tip-catheters-fda-510k.jpg K992673 - VISTA BRITE TIP CATHETERS K992673 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Oct 1999. https://www.510kdatabase.net/k991256/ 1999-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k991256-viewpoint-entorthopedic-option-fda-510k.jpg K991256 - VIEWPOINT ENT/ORTHOPEDIC OPTION K991256 is a FDA 510(k) cleared neurology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Oct 1999. https://www.510kdatabase.net/k992326/ 1999-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k992326-3m-clinpro-sealant-fda-510k.jpg K992326 - 3M CLINPRO SEALANT K992326 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Oct 1999. https://www.510kdatabase.net/k992347/ 1999-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k992347-cordis-super-torque-mb-angiographic-fda-510k.jpg K992347 - CORDIS SUPER TORQUE MB ANGIOGRAPHIC CATHETER WITH RADIOPAQUE MARKER BANDS K992347 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Oct 1999. https://www.510kdatabase.net/k993025/ 1999-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k993025-modification-to-bone-mulch-screw-system-fda-510k.jpg K993025 - MODIFICATION TO BONE MULCH SCREW SYSTEM K993025 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Oct 1999. https://www.510kdatabase.net/k993077/ 1999-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k993077-howmedica-osteonics-restoration-ha-hip-fda-510k.jpg K993077 - HOWMEDICA OSTEONICS RESTORATION HA HIP STEM K993077 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Oct 1999. https://www.510kdatabase.net/k984590/ 1999-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k984590-09-sodium-chloride-flush-syringe-fda-510k.jpg K984590 - 0.9% SODIUM CHLORIDE FLUSH SYRINGE K984590 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Oct 1999. https://www.510kdatabase.net/k992309/ 1999-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k992309-introducer-sheath-vessel-dilator-fda-510k.jpg K992309 - INTRODUCER SHEATH, VESSEL DILATOR K992309 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Oct 1999. https://www.510kdatabase.net/k992335/ 1999-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k992335-beacon-p-model-211059-fda-510k.jpg K992335 - BEACON-P, MODEL 211059 K992335 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Oct 1999. https://www.510kdatabase.net/k993038/ 1999-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k993038-toshiba-rtp9211j-g11-j-advanced-image-fda-510k.jpg K993038 - TOSHIBA RTP9211J-G11, J-ADVANCED IMAGE INTENSIFIER (I.I.) K993038 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Oct 1999. https://www.510kdatabase.net/k992956/ 1999-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k992956-lucitone-frs-flexibel-dental-resin-fda-510k.jpg K992956 - LUCITONE FRS FLEXIBEL DENTAL RESIN K992956 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Oct 1999. https://www.510kdatabase.net/k993004/ 1999-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k993004-alta-fully-threaded-cross-locking-50-fda-510k.jpg K993004 - ALTA FULLY THREADED CROSS-LOCKING 5.0 MM SCREW K993004 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Oct 1999. https://www.510kdatabase.net/k990723/ 1999-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k990723-dyonics-varicose-vein-ablation-blade-fda-510k.jpg K990723 - DYONICS VARICOSE VEIN ABLATION BLADE K990723 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 1999. https://www.510kdatabase.net/k993055/ 1999-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k993055-dexide-bipolar-forceps-ii-device-fda-510k.jpg K993055 - DEXIDE BIPOLAR FORCEPS II** DEVICE K993055 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Oct 1999. https://www.510kdatabase.net/k993057/ 1999-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k993057-mba-fda-510k.jpg K993057 - MBA K993057 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Oct 1999. https://www.510kdatabase.net/k993083/ 1999-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k993083-alcyon-300i-with-ise-module-analyzer-fda-510k.jpg K993083 - ALCYON 300I (WITH ISE MODULE) ANALYZER K993083 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1999. https://www.510kdatabase.net/k992292/ 1999-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k992292-gluma-comfort-bond-desensitizer-fda-510k.jpg K992292 - GLUMA COMFORT BOND + DESENSITIZER K992292 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Oct 1999. https://www.510kdatabase.net/k992734/ 1999-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k992734-becton-dickinson-syringe-fda-510k.jpg K992734 - BECTON DICKINSON SYRINGE K992734 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1999. https://www.510kdatabase.net/k990992/ 1999-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k990992-integra-reagent-cassette-for-fda-510k.jpg K990992 - INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN ALC K990992 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Sep 1999. https://www.510kdatabase.net/k992680/ 1999-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k992680-elecsys-parathyroid-hormone-test-system-fda-510k.jpg K992680 - ELECSYS PARATHYROID HORMONE TEST SYSTEM K992680 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Sep 1999. https://www.510kdatabase.net/k992798/ 1999-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k992798-sigma-diagnostics-infinity-uric-acid-fda-510k.jpg K992798 - SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100P K992798 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Sep 1999. https://www.510kdatabase.net/k992800/ 1999-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k992800-sigma-diagnostics-infinity-bun-reagent-fda-510k.jpg K992800 - SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P K992800 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Sep 1999. https://www.510kdatabase.net/k992801/ 1999-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k992801-sigma-diagnostics-infinity-astbun-fda-510k.jpg K992801 - SIGMA DIAGNOSTICS INFINITY ASTBUN REAGENT, MODEL 51-25, SIGMA DIAGNOSTICS INFINITY AST REAGENT, MODELS 51-100P,51-500P,5 K992801 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Sep 1999. https://www.510kdatabase.net/k992444/ 1999-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k992444-modification-of-cell-dyn-1200-system-fda-510k.jpg K992444 - MODIFICATION OF: CELL-DYN 1200 SYSTEM K992444 is a FDA 510(k) cleared hematology medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1999. https://www.510kdatabase.net/k992526/ 1999-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k992526-flexible-nasopharyngo-laryngoscopes-fda-510k.jpg K992526 - FLEXIBLE NASOPHARYNGO-LARYNGOSCOPES, FLEXIBLE BRONCHOSCOPE K992526 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Sep 1999. https://www.510kdatabase.net/k992981/ 1999-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k992981-elecsys-estradiol-calset-ii-fda-510k.jpg K992981 - ELECSYS ESTRADIOL CALSET II K992981 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Sep 1999. https://www.510kdatabase.net/k991551/ 1999-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k991551-vacutainer-brand-sodium-citrate-fda-510k.jpg K991551 - VACUTAINER BRAND SODIUM CITRATE PEDIATRIC TUBE K991551 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1999. https://www.510kdatabase.net/k992348/ 1999-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k992348-synthes-spiral-blade-for-humeral-nail-fda-510k.jpg K992348 - SYNTHES SPIRAL BLADE FOR HUMERAL NAIL (SBHN) K992348 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Sep 1999. https://www.510kdatabase.net/k992849/ 1999-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k992849-qbc-star-centrifugal-hematology-system-fda-510k.jpg K992849 - QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEM K992849 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1999. https://www.510kdatabase.net/k992518/ 1999-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k992518-prime-bond-nt-dual-cure-universal-fda-510k.jpg K992518 - PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM K992518 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Sep 1999. https://www.510kdatabase.net/k993069/ 1999-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k993069-ge-diasonics-gateway-and-gateway-fx-fda-510k.jpg K993069 - GE DIASONICS GATEWAY AND GATEWAY FX K993069 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Sep 1999. https://www.510kdatabase.net/k992199/ 1999-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k992199-acid-hemoglobin-kit-fda-510k.jpg K992199 - ACID HEMOGLOBIN KIT K992199 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Sep 1999. https://www.510kdatabase.net/k992423/ 1999-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k992423-sysmex-automated-coagulation-analyzer-fda-510k.jpg K992423 - SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500 K992423 is a FDA 510(k) cleared hematology medical device. Manufacturer: Dade Behring, Inc.. Cleared Sep 1999. https://www.510kdatabase.net/k992763/ 1999-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k992763-sysmex-automated-coagulation-analyzer-fda-510k.jpg K992763 - SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500 K992763 is a FDA 510(k) cleared hematology medical device. Manufacturer: Dade Behring, Inc.. Cleared Sep 1999. https://www.510kdatabase.net/k983410/ 1999-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k983410-target-fda-510k.jpg K983410 - @ TARGET K983410 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Sep 1999. https://www.510kdatabase.net/k984358/ 1999-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k984358-olympus-distal-attachment-models-mh-fda-510k.jpg K984358 - OLYMPUS DISTAL ATTACHMENT, MODELS MH-462,-463,-464,-465,-466,-483,-587,-588,-589,-590,-591,-592,-593,-594,-595,-596,-597 K984358 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus America, Inc.. Cleared Sep 1999. https://www.510kdatabase.net/k992321/ 1999-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k992321-sysmex-automated-coagulation-analyzer-fda-510k.jpg K992321 - SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000 K992321 is a FDA 510(k) cleared hematology medical device. Manufacturer: Dade Behring, Inc.. Cleared Sep 1999. https://www.510kdatabase.net/k992903/ 1999-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k992903-color-buffed-cemented-femoral-fda-510k.jpg K992903 - COLOR BUFFED CEMENTED FEMORAL K992903 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Sep 1999. https://www.510kdatabase.net/k992825/ 1999-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k992825-cordis-extreme-pta-balloon-catheter-fda-510k.jpg K992825 - CORDIS EXTREME PTA BALLOON CATHETER K992825 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Sep 1999. https://www.510kdatabase.net/k992910/ 1999-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k992910-affinity-nt-hollow-fiber-oxygenator-fda-510k.jpg K992910 - AFFINITY NT HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER WITH BALANCE BIOCOMPATIBLE SURFACE (MODEL 511B) K992910 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Sep 1999. https://www.510kdatabase.net/k991066/ 1999-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k991066-madtronic-dlp-arterial-cannulae-fda-510k.jpg K991066 - MADTRONIC DLP ARTERIAL CANNULAE K991066 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Sep 1999. https://www.510kdatabase.net/k973971/ 1999-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k973971-kion-anesthesia-system-fda-510k.jpg K973971 - KION ANESTHESIA SYSTEM K973971 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 1999. https://www.510kdatabase.net/k992119/ 1999-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k992119-bio-modular-shoulder-system-fda-510k.jpg K992119 - BIO-MODULAR SHOULDER SYSTEM K992119 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Sep 1999. https://www.510kdatabase.net/k992803/ 1999-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k992803-sigma-diagnostics-infinity-cholesterol-fda-510k.jpg K992803 - SIGMA DIAGNOSTICS INFINITY CHOLESTEROL REAGENT, MODELS 401-25, 401-100P, 401-500P, 401-2000P, 402-20, 02-1OOP K992803 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Sep 1999. https://www.510kdatabase.net/k991375/ 1999-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k991375-bard-balloon-inflation-system-fda-510k.jpg K991375 - BARD BALLOON INFLATION SYSTEM K991375 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Sep 1999. https://www.510kdatabase.net/k991990/ 1999-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k991990-tri-polar-system-fda-510k.jpg K991990 - TRI-POLAR SYSTEM K991990 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Sep 1999. https://www.510kdatabase.net/k992073/ 1999-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k992073-ax-workstation-fda-510k.jpg K992073 - AX WORKSTATION K992073 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 1999. https://www.510kdatabase.net/k992237/ 1999-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k992237-medtronic-gt2-fusion-guide-wires-fda-510k.jpg K992237 - MEDTRONIC GT2 FUSION GUIDE WIRES K992237 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Sep 1999. https://www.510kdatabase.net/k992802/ 1999-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k992802-terumo-u-100-insulin-syringe-fda-510k.jpg K992802 - TERUMO U-100 INSULIN SYRINGE K992802 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terumo Medical Corp.. Cleared Sep 1999. https://www.510kdatabase.net/k991683/ 1999-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k991683-ptfe-ringed-gore-tex-vascular-graft-fda-510k.jpg K991683 - PTFE RINGED GORE-TEX VASCULAR GRAFT K991683 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Sep 1999. https://www.510kdatabase.net/k992225/ 1999-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k992225-quantitative-flow-fda-510k.jpg K992225 - QUANTITATIVE FLOW K992225 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Sep 1999. https://www.510kdatabase.net/k992610/ 1999-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k992610-gendex-765dc-model-110-0154-fda-510k.jpg K992610 - GENDEX 765DC, MODEL 110-0154 K992610 is a FDA 510(k) cleared radiology medical device. Manufacturer: Dentsply Intl.. Cleared Sep 1999. https://www.510kdatabase.net/k991180/ 1999-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k991180-borrelia-burgdorferi-igg-western-blot-fda-510k.jpg K991180 - BORRELIA BURGDORFERI IGG WESTERN BLOT TEST SYSTEM K991180 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Sep 1999. https://www.510kdatabase.net/k991185/ 1999-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k991185-borrelia-burgdorferi-igm-western-blot-fda-510k.jpg K991185 - BORRELIA BURGDORFERI IGM WESTERN BLOT TEST SYSTEM K991185 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Sep 1999. https://www.510kdatabase.net/k991915/ 1999-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k991915-modular-radial-head-fda-510k.jpg K991915 - MODULAR RADIAL HEAD K991915 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Sep 1999. https://www.510kdatabase.net/k991973/ 1999-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k991973-capiox-sx10-hardshell-resevoir-fda-510k.jpg K991973 - CAPIOX SX10 HARDSHELL RESEVOIR K991973 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Sep 1999. https://www.510kdatabase.net/k992063/ 1999-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k992063-osteo-ic-femoral-and-tibial-nails-in-fda-510k.jpg K992063 - OSTEO IC FEMORAL AND TIBIAL NAILS IN TITANIUM ALLOY K992063 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Sep 1999. https://www.510kdatabase.net/k992166/ 1999-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k992166-the-aptus-automated-application-of-the-fda-510k.jpg K992166 - THE APTUS (AUTOMATED) APPLICATION OF THE HSV 1/2 IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR K992166 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Sep 1999. https://www.510kdatabase.net/k992172/ 1999-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k992172-lyphochek-tumor-marker-control-model-580-fda-510k.jpg K992172 - LYPHOCHEK TUMOR MARKER CONTROL, MODEL 580 K992172 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Sep 1999. https://www.510kdatabase.net/k991899/ 1999-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k991899-nihon-kohden-meb-2200a-neuropack-fda-510k.jpg K991899 - NIHON KOHDEN MEB-2200A NEUROPACK EVOKED POTENTIAL & EMG MEASURING SYSTEM WITH ACCESSORIES K991899 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Sep 1999. https://www.510kdatabase.net/k991922/ 1999-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k991922-digital-imaging-system-bsr-fda-510k.jpg K991922 - DIGITAL IMAGING SYSTEM (BSR) K991922 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 1999. https://www.510kdatabase.net/k992570/ 1999-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k992570-unitrax-c-taper-neck-adjustment-sleeve-fda-510k.jpg K992570 - UNITRAX C-TAPER NECK ADJUSTMENT SLEEVE K992570 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Sep 1999. https://www.510kdatabase.net/k992636/ 1999-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k992636-hp-carevue-9000-clinical-information-fda-510k.jpg K992636 - HP CAREVUE 9000 CLINICAL INFORMATION SYSTEM, MODEL M2331A K992636 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Aug 1999. https://www.510kdatabase.net/k992066/ 1999-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k992066-revolution-txi-digital-radiographic-fda-510k.jpg K992066 - REVOLUTION TX/I DIGITAL RADIOGRAPHIC TABLE SYSTEM K992066 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Aug 1999. https://www.510kdatabase.net/k991055/ 1999-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k991055-osteonics-spinal-system-rod-plate-system-fda-510k.jpg K991055 - OSTEONICS SPINAL SYSTEM- ROD/ PLATE SYSTEM K991055 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Aug 1999. https://www.510kdatabase.net/k992198/ 1999-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k992198-urethane-picc-line-model-upics--fda-510k.jpg K992198 - URETHANE PICC LINE MODEL UPICS- K992198 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cook, Inc.. Cleared Aug 1999. https://www.510kdatabase.net/k992516/ 1999-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k992516-dyract-seal-compomer-pit-fissure-sealant-fda-510k.jpg K992516 - DYRACT SEAL COMPOMER PIT & FISSURE SEALANT K992516 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Aug 1999. https://www.510kdatabase.net/k991559/ 1999-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k991559-medline-prohibit-series-surgical-mask-fda-510k.jpg K991559 - MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD K991559 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Aug 1999. https://www.510kdatabase.net/k991943/ 1999-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k991943-mrgp-optical-tracking-unit-fda-510k.jpg K991943 - MRGP OPTICAL TRACKING UNIT K991943 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Aug 1999. https://www.510kdatabase.net/k991909/ 1999-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k991909-delton-fs-with-fluoride-pit-fissure-fda-510k.jpg K991909 - DELTON FS WITH FLUORIDE PIT & FISSURE SEALANT K991909 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Aug 1999. https://www.510kdatabase.net/k991985/ 1999-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k991985-cook-high-volume-infusion-adapter-fda-510k.jpg K991985 - COOK HIGH VOLUME INFUSION ADAPTER INTRAVASCULAR ADMINISTRATION SET K991985 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cook, Inc.. Cleared Aug 1999. https://www.510kdatabase.net/k992158/ 1999-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k992158-lactosorb-sheets-fda-510k.jpg K992158 - LACTOSORB SHEETS K992158 is a FDA 510(k) cleared dental medical device. Manufacturer: Biomet, Inc.. Cleared Aug 1999. https://www.510kdatabase.net/k990630/ 1999-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k990630-sas-adeno-test-fda-510k.jpg K990630 - SAS ADENO TEST K990630 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Aug 1999. https://www.510kdatabase.net/k992086/ 1999-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k992086-olympus-serum-protein-multicalibrator-2-fda-510k.jpg K992086 - OLYMPUS SERUM PROTEIN MULTICALIBRATOR 2 K992086 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Olympus America, Inc.. Cleared Aug 1999. https://www.510kdatabase.net/k991585/ 1999-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k991585-bipolar-shoulder-prosthesis-fda-510k.jpg K991585 - BIPOLAR SHOULDER PROSTHESIS K991585 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Aug 1999. https://www.510kdatabase.net/k991753/ 1999-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k991753-maxim-removable-molded-poly-tibia-fda-510k.jpg K991753 - MAXIM REMOVABLE MOLDED POLY TIBIA K991753 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Aug 1999. https://www.510kdatabase.net/k991764/ 1999-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k991764-somatom-project-10-ct-scanners-fda-510k.jpg K991764 - SOMATOM PROJECT 10-CT SCANNERS K991764 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 1999. https://www.510kdatabase.net/k992412/ 1999-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k992412-ipass-bolus-tracking-fda-510k.jpg K992412 - IPASS BOLUS TRACKING K992412 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Aug 1999. https://www.510kdatabase.net/k983577/ 1999-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k983577-arthrex-meniscal-dart-system-fda-510k.jpg K983577 - ARTHREX MENISCAL DART SYSTEM K983577 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Aug 1999. https://www.510kdatabase.net/k992025/ 1999-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k992025-precision-osteolock-femoral-stems-with-fda-510k.jpg K992025 - PRECISION OSTEOLOCK FEMORAL STEMS WITH PURE-FIX HA COATING K992025 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Aug 1999. https://www.510kdatabase.net/k992046/ 1999-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k992046-sonoline-7xx-diagnostic-ultrasound-fda-510k.jpg K992046 - SONOLINE 7XX DIAGNOSTIC ULTRASOUND SYSTEM K992046 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 1999. https://www.510kdatabase.net/k992336/ 1999-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k992336-monarch-ii-mini-mask-fda-510k.jpg K992336 - MONARCH II MINI MASK K992336 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Aug 1999. https://www.510kdatabase.net/k992462/ 1999-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k992462-osteonics-universal-distal-cement-plug-fda-510k.jpg K992462 - OSTEONICS UNIVERSAL DISTAL CEMENT PLUG K992462 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Aug 1999. https://www.510kdatabase.net/k984304/ 1999-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k984304-riwo-drive-generator-fda-510k.jpg K984304 - RIWO DRIVE GENERATOR K984304 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Aug 1999. https://www.510kdatabase.net/k991674/ 1999-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k991674-cordis-palmaz-corinthian-transhepatic-fda-510k.jpg K991674 - CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, MODELS PC155BJS, PCI156BJS, PC185BJS, PC186BJS K991674 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Aug 1999. https://www.510kdatabase.net/k991718/ 1999-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k991718-operating-laparoscope-10-5-mm-angeled-fda-510k.jpg K991718 - OPERATING LAPAROSCOPE, 10-5 MM, ANGELED, OPERATING LAPAROSCOPE 12-7MM, ANGLED, OPERATING LAPAROSCOPE, 10-5,,. OBLIQUE, D K991718 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Aug 1999. https://www.510kdatabase.net/k991820/ 1999-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k991820-helicobacter-pylori-igg-elisa-test-fda-510k.jpg K991820 - HELICOBACTER PYLORI IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)FOR THE DETECTION OF IGG ANTIBODI K991820 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Aug 1999. https://www.510kdatabase.net/k992346/ 1999-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k992346-kinematic-ii-rotating-hinge-knee-fda-510k.jpg K992346 - KINEMATIC II ROTATING HINGE KNEE K992346 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Aug 1999. https://www.510kdatabase.net/k992550/ 1999-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k992550-liquichek-immunology-control-level-1-2-3-fda-510k.jpg K992550 - LIQUICHEK IMMUNOLOGY CONTROL LEVEL 1, 2, 3 K992550 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Aug 1999. https://www.510kdatabase.net/k991766/ 1999-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k991766-ecg-gating-system-for-aquilion-ct-fda-510k.jpg K991766 - ECG-GATING SYSTEM FOR AQUILION CT SCANNER, TSX-101A K991766 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Aug 1999. https://www.510kdatabase.net/k992051/ 1999-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k992051-radifocus-optitorque-fda-510k.jpg K992051 - RADIFOCUS OPTITORQUE K992051 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Aug 1999. https://www.510kdatabase.net/k984532/ 1999-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k984532-cadplan-helios-option-60-fda-510k.jpg K984532 - CADPLAN HELIOS OPTION 6.0 K984532 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Aug 1999. https://www.510kdatabase.net/k990842/ 1999-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k990842-sas-rota-test-fda-510k.jpg K990842 - SAS ROTA TEST K990842 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Aug 1999. https://www.510kdatabase.net/k991961/ 1999-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k991961-3m-lvr-system-fda-510k.jpg K991961 - 3M LVR SYSTEM K991961 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Aug 1999. https://www.510kdatabase.net/k990666/ 1999-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k990666-hydroxyapatite-ha-reflection-fda-510k.jpg K990666 - HYDROXYAPATITE (HA) REFLECTION ACETABULAR SHELL, HYDROXYAPATITE (HA) REFLECTION INTERFIT SHELL K990666 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Aug 1999. https://www.510kdatabase.net/k991871/ 1999-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k991871-hewlett-packard-multi-function-adult-fda-510k.jpg K991871 - HEWLETT PACKARD MULTI FUNCTION ADULT DEFIB ELECTRODE, MODEL M3501A & M3502A K991871 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Aug 1999. https://www.510kdatabase.net/k991028/ 1999-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k991028-cordis-palmaz-corinthian-transhepatic-fda-510k.jpg K991028 - CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND ACCESSORIES K991028 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Aug 1999. https://www.510kdatabase.net/k991157/ 1999-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k991157-n-latex-stfr-reagent-fda-510k.jpg K991157 - N LATEX STFR REAGENT K991157 is a FDA 510(k) cleared immunology medical device. Manufacturer: Dade Behring, Inc.. Cleared Aug 1999. https://www.510kdatabase.net/k984054/ 1999-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k984054-agc-v2-revision-knee-system-fda-510k.jpg K984054 - AGC V2 REVISION KNEE SYSTEM K984054 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jul 1999. https://www.510kdatabase.net/k991581/ 1999-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k991581-nexgen-complete-knee-solution-legacy-fda-510k.jpg K991581 - NEXGEN COMPLETE KNEE SOLUTION LEGACY POSTERIOR STABILIZED (LPS) K991581 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jul 1999. https://www.510kdatabase.net/k991708/ 1999-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k991708-zirconia-2222mm-ceramic-modular-heads-fda-510k.jpg K991708 - ZIRCONIA 22.22MM CERAMIC MODULAR HEADS K991708 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jul 1999. https://www.510kdatabase.net/k991763/ 1999-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k991763-lactosorb-hand-system-fda-510k.jpg K991763 - LACTOSORB HAND SYSTEM K991763 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jul 1999. https://www.510kdatabase.net/k991968/ 1999-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k991968-cicacare-roll-on-gel-scar-management-fda-510k.jpg K991968 - CICACARE ROLL-ON GEL-SCAR MANAGEMENT LIQUID GEL. K991968 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 1999. https://www.510kdatabase.net/k992344/ 1999-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k992344-osteonics-accp-system-line-extension-fda-510k.jpg K992344 - OSTEONICS ACCP SYSTEM LINE EXTENSION K992344 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jul 1999. https://www.510kdatabase.net/k992189/ 1999-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k992189-gore-tex-dualmesh-biomaterial-fda-510k.jpg K992189 - GORE-TEX DUALMESH BIOMATERIAL K992189 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Jul 1999. https://www.510kdatabase.net/k984501/ 1999-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k984501-dade-behring-bftii-fda-510k.jpg K984501 - DADE BEHRING BFTII K984501 is a FDA 510(k) cleared hematology medical device. Manufacturer: Dade Behring, Inc.. Cleared Jul 1999. https://www.510kdatabase.net/k992167/ 1999-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k992167-performance-knee-system-fda-510k.jpg K992167 - PERFORMANCE KNEE SYSTEM K992167 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jul 1999. https://www.510kdatabase.net/k984060/ 1999-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k984060-luer-access-injection-site-fda-510k.jpg K984060 - LUER ACCESS INJECTION SITE K984060 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jul 1999. https://www.510kdatabase.net/k980070/ 1999-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k980070-osteonics-ha-coated-devices-fda-510k.jpg K980070 - OSTEONICS HA-COATED DEVICES K980070 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Jul 1999. https://www.510kdatabase.net/k992231/ 1999-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k992231-fountain-infusion-catheter-and-fda-510k.jpg K992231 - FOUNTAIN Infusion Catheter and Occluding Guide Wire K992231 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jul 1999. https://www.510kdatabase.net/k991597/ 1999-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k991597-cobas-integra-amikacin-mab-fda-510k.jpg K991597 - COBAS INTEGRA AMIKACIN MAB K991597 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jul 1999. https://www.510kdatabase.net/k991598/ 1999-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k991598-cobas-integra-acetaminophen-fda-510k.jpg K991598 - COBAS INTEGRA ACETAMINOPHEN K991598 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jul 1999. https://www.510kdatabase.net/k984180/ 1999-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k984180-the-aptus-automated-application-of-the-fda-510k.jpg K984180 - THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGM ELISA TEST SYSTEM K984180 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Jul 1999. https://www.510kdatabase.net/k990712/ 1999-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k990712-osteonics-solar-shoulder-bipolar-system-fda-510k.jpg K990712 - OSTEONICS SOLAR SHOULDER BIPOLAR SYSTEM K990712 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jul 1999. https://www.510kdatabase.net/k991860/ 1999-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k991860-synthes-cranial-flap-twist-clamp-fda-510k.jpg K991860 - SYNTHES CRANIAL FLAP TWIST CLAMP K991860 is a FDA 510(k) cleared neurology medical device. Manufacturer: Synthes (Usa). Cleared Jul 1999. https://www.510kdatabase.net/k991957/ 1999-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k991957-cicacare-management-for-scars-fda-510k.jpg K991957 - CICACARE MANAGEMENT FOR SCARS K991957 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 1999. https://www.510kdatabase.net/k992000/ 1999-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k992000-synthes-cranial-flap-tube-clamp-fda-510k.jpg K992000 - SYNTHES CRANIAL FLAP TUBE CLAMP K992000 is a FDA 510(k) cleared neurology medical device. Manufacturer: Synthes (Usa). Cleared Jul 1999. https://www.510kdatabase.net/k991568/ 1999-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k991568-mr-spectroscopy-package-fda-510k.jpg K991568 - MR SPECTROSCOPY PACKAGE K991568 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Jul 1999. https://www.510kdatabase.net/k991705/ 1999-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k991705-n-protein-standard-uy-fda-510k.jpg K991705 - N PROTEIN STANDARD UY K991705 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Jul 1999. https://www.510kdatabase.net/k991649/ 1999-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k991649-depuy-rockwood-clavicle-pin-fda-510k.jpg K991649 - DEPUY ROCKWOOD CLAVICLE PIN K991649 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jul 1999. https://www.510kdatabase.net/k982326/ 1999-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k982326-medi-tech-dialysis-catheter-fda-510k.jpg K982326 - MEDI-TECH DIALYSIS CATHETER GASTROENTEROLOGY K982326 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Jul 1999. https://www.510kdatabase.net/k983203/ 1999-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k983203-immulite-epo-model-s-lkepz-lkep1-fda-510k.jpg K983203 - IMMULITE EPO, MODEL #'S LKEPZ & LKEP1 K983203 is a FDA 510(k) cleared hematology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jul 1999. https://www.510kdatabase.net/k990135/ 1999-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k990135-trilogy-acetabular-system-longevity-fda-510k.jpg K990135 - TRILOGY ACETABULAR SYSTEM LONGEVITY CROSSLINKED POLYETHYLENE K990135 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jul 1999. https://www.510kdatabase.net/k990237/ 1999-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k990237-trocar-system-according-to-hasson-fda-510k.jpg K990237 - TROCAR SYSTEM ACCORDING TO HASSON K990237 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Olympus America, Inc.. Cleared Jul 1999. https://www.510kdatabase.net/k991485/ 1999-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k991485-synergy-porous-size-8-hip-stem-fda-510k.jpg K991485 - SYNERGY POROUS SIZE 8 HIP STEM K991485 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 1999. https://www.510kdatabase.net/k992065/ 1999-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k992065-global-advantage-shoulder-global-fda-510k.jpg K992065 - GLOBAL ADVANTAGE SHOULDER, GLOBAL ADVANTAGE HUMERAL STEM, GLOBAL ADVANTAGE ECCENTRIC HEAD K992065 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jul 1999. https://www.510kdatabase.net/k991222/ 1999-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k991222-codman-microsensor-ventricular-fda-510k.jpg K991222 - CODMAN MICROSENSOR VENTRICULAR CATHETER KIT K991222 is a FDA 510(k) cleared neurology medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jul 1999. https://www.510kdatabase.net/k991602/ 1999-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k991602-eptfe-ringed-gore-tex-vascular-graft-fda-510k.jpg K991602 - EPTFE RINGED GORE-TEX VASCULAR GRAFT K991602 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Jul 1999. https://www.510kdatabase.net/k991605/ 1999-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k991605-cell-dyn-3500-system-with-immature-fda-510k.jpg K991605 - CELL-DYN 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), CELL-DYN 3700 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION K991605 is a FDA 510(k) cleared hematology medical device. Manufacturer: Abbott Laboratories. Cleared Jul 1999. https://www.510kdatabase.net/k983764/ 1999-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k983764-viewpoint-tools-sterrad-fda-510k.jpg K983764 - VIEWPOINT TOOLS- STERRAD K983764 is a FDA 510(k) cleared neurology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Jul 1999. https://www.510kdatabase.net/k991807/ 1999-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k991807-titanium-low-profile-screws-fda-510k.jpg K991807 - TITANIUM LOW PROFILE SCREWS K991807 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jul 1999. https://www.510kdatabase.net/k991787/ 1999-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k991787-n-latex-ige-mono-reagent-fda-510k.jpg K991787 - N LATEX IGE MONO REAGENT K991787 is a FDA 510(k) cleared immunology medical device. Manufacturer: Dade Behring, Inc.. Cleared Jul 1999. https://www.510kdatabase.net/k991323/ 1999-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k991323-smith-nephew-subcutaneous-illuminator-fda-510k.jpg K991323 - SMITH & NEPHEW SUBCUTANEOUS ILLUMINATOR K991323 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 1999. https://www.510kdatabase.net/k992105/ 1999-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k992105-immulite-turbo-intact-pth-model-lskptz-fda-510k.jpg K992105 - IMMULITE TURBO INTACT PTH, MODEL LSKPTZ K992105 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jul 1999. https://www.510kdatabase.net/k990965/ 1999-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k990965-synthes-cervifix-system-fda-510k.jpg K990965 - SYNTHES CERVIFIX SYSTEM K990965 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jul 1999. https://www.510kdatabase.net/k991176/ 1999-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k991176-opus-troponin-i-calibrator-fda-510k.jpg K991176 - OPUS TROPONIN I CALIBRATOR K991176 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Jul 1999. https://www.510kdatabase.net/k991177/ 1999-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k991177-opus-troponin-i-ctn-test-modules-fda-510k.jpg K991177 - OPUS TROPONIN I (CTN) TEST MODULES K991177 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Jul 1999. https://www.510kdatabase.net/k992058/ 1999-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k992058-bi-metric-ccocr-headneck-replacement-fda-510k.jpg K992058 - BI-METRIC CCOCR HEAD/NECK REPLACEMENT SYSTEM K992058 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jul 1999. https://www.510kdatabase.net/k991952/ 1999-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k991952-osteonics-alumina-c-taper-head-fda-510k.jpg K991952 - OSTEONICS ALUMINA C-TAPER HEAD, OSTEONICS TRIDENT POLYETHYLENE INSERTS K991952 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jun 1999. https://www.510kdatabase.net/k990998/ 1999-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k990998-polyslit-ife-kit-fda-510k.jpg K990998 - POLYSLIT IFE KIT K990998 is a FDA 510(k) cleared immunology medical device. Manufacturer: Helena Laboratories. Cleared Jun 1999. https://www.510kdatabase.net/k991987/ 1999-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k991987-color-buffed-answer-cemented-femoral-fda-510k.jpg K991987 - COLOR BUFFED ANSWER CEMENTED FEMORAL K991987 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jun 1999. https://www.510kdatabase.net/k990771/ 1999-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k990771-6f-hydrolyser-thrombectomy-catheter-fda-510k.jpg K990771 - 6F HYDROLYSER THROMBECTOMY CATHETER K990771 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Jun 1999. https://www.510kdatabase.net/k991610/ 1999-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k991610-zeus-scientific-inc-tpo-igg-elisa-test-fda-510k.jpg K991610 - ZEUS SCIENTIFIC INC., TPO IGG ELISA TEST SYSTEM. K991610 is a FDA 510(k) cleared immunology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Jun 1999. https://www.510kdatabase.net/k991704/ 1999-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k991704-nt-protein-control-lc-fda-510k.jpg K991704 - N/T PROTEIN CONTROL LC K991704 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Jun 1999. https://www.510kdatabase.net/k991012/ 1999-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k991012-siemens-infinity-eeg-pod-fda-510k.jpg K991012 - SIEMENS INFINITY EEG POD K991012 is a FDA 510(k) cleared neurology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 1999. https://www.510kdatabase.net/k982467/ 1999-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k982467-capiox-cardioplegia-fda-510k.jpg K982467 - CAPIOX CARDIOPLEGIA K982467 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Jun 1999. https://www.510kdatabase.net/k991004/ 1999-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k991004-synthes-quick-lock-imf-system-fda-510k.jpg K991004 - SYNTHES QUICK LOCK IMF SYSTEM K991004 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Jun 1999. https://www.510kdatabase.net/k991009/ 1999-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k991009-rc-buttress-fda-510k.jpg K991009 - RC BUTTRESS K991009 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jun 1999. https://www.510kdatabase.net/k991142/ 1999-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k991142-cell-dyn-1200-system-fda-510k.jpg K991142 - CELL-DYN 1200 SYSTEM K991142 is a FDA 510(k) cleared hematology medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1999. https://www.510kdatabase.net/k991859/ 1999-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k991859-dexide-bipolar-forceps-ii-device-fda-510k.jpg K991859 - DEXIDE BIPOLAR FORCEPS II ** DEVICE K991859 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Jun 1999. https://www.510kdatabase.net/k983344/ 1999-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k983344-dade-behring-quiklyte-metabolyte-fda-510k.jpg K983344 - DADE BEHRING QUIKLYTE METABOLYTE CARTRIDGE, MODEL DIMENSION(R) XL OR RXL K983344 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Jun 1999. https://www.510kdatabase.net/k991056/ 1999-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k991056-wallstent-enteral-endoprosthesis-with-fda-510k.jpg K991056 - WALLSTENT ENTERAL ENDOPROSTHESIS WITH UNISTEP DELIVERY SYSTEM K991056 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Jun 1999. https://www.510kdatabase.net/k991440/ 1999-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k991440-roche-cobas-integra-serum-barbiturates-fda-510k.jpg K991440 - ROCHE COBAS INTEGRA SERUM BARBITURATES K991440 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jun 1999. https://www.510kdatabase.net/k991443/ 1999-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k991443-roche-cobas-integra-serum-fda-510k.jpg K991443 - ROCHE COBAS INTEGRA SERUM BENZODIAZEPINES (SBENZ) K991443 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Jun 1999. https://www.510kdatabase.net/k990953/ 1999-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k990953-renal-link-fda-510k.jpg K990953 - RENAL LINK K990953 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jun 1999. https://www.510kdatabase.net/k991179/ 1999-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k991179-zeus-scientific-inc-thyroglobulin-igg-fda-510k.jpg K991179 - ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM K991179 is a FDA 510(k) cleared immunology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Jun 1999. https://www.510kdatabase.net/k991657/ 1999-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k991657-quanta-lite-ana-elisa-fda-510k.jpg K991657 - QUANTA LITE ANA ELISA K991657 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Jun 1999. https://www.510kdatabase.net/k991406/ 1999-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k991406-terumo-surflo-flex-iv-catheter-and-fda-510k.jpg K991406 - TERUMO SURFLO FLEX I.V. CATHETER AND TERUMO SURFLASH I.V. CATHETER K991406 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terumo Medical Corp.. Cleared Jun 1999. https://www.510kdatabase.net/k991858/ 1999-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k991858-ssa-390apower-vision-8000-fda-510k.jpg K991858 - SSA-390A/POWER VISION 8000 K991858 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Jun 1999. https://www.510kdatabase.net/k991425/ 1999-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k991425-xantopren-comfort-fda-510k.jpg K991425 - XANTOPREN COMFORT K991425 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Jun 1999. https://www.510kdatabase.net/k991811/ 1999-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k991811-cordis-maxi-ds-pta-balloon-catheter-fda-510k.jpg K991811 - CORDIS MAXI DS PTA BALLOON CATHETER K991811 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Jun 1999. https://www.510kdatabase.net/k990864/ 1999-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k990864-speedband-superview-multiple-band-fda-510k.jpg K990864 - SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR, MODELS 4225, 4228 K990864 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Jun 1999. https://www.510kdatabase.net/k991178/ 1999-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k991178-flexible-fiberscope-model-7331001-fda-510k.jpg K991178 - FLEXIBLE FIBERSCOPE, MODEL 7331.001, GUIDE SECTION FOR LITHOVAC HANDPIECE, MODEL 8708.253 K991178 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Jun 1999. https://www.510kdatabase.net/k991407/ 1999-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k991407-synthes-locking-calcaneal-plates-fda-510k.jpg K991407 - SYNTHES LOCKING CALCANEAL PLATES K991407 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jun 1999. https://www.510kdatabase.net/k991127/ 1999-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k991127-variant-ii-b-thalassemia-fda-510k.jpg K991127 - VARIANT II B-THALASSEMIA K991127 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bio-Rad. Cleared Jun 1999. https://www.510kdatabase.net/k990063/ 1999-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k990063-nihon-kohden-tg-901t-co2-sensor-kit-fda-510k.jpg K990063 - NIHON KOHDEN TG-901T CO2 SENSOR KIT WITH ACCESSORIES K990063 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Jun 1999. https://www.510kdatabase.net/k991106/ 1999-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k991106-pfc-sigma-porous-modular-keel-tibial-fda-510k.jpg K991106 - P.F.C. SIGMA POROUS MODULAR KEEL TIBIAL TRAY K991106 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jun 1999. https://www.510kdatabase.net/k991611/ 1999-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k991611-ge-logiq-500-fda-510k.jpg K991611 - GE LOGIQ 500 K991611 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jun 1999. https://www.510kdatabase.net/k991619/ 1999-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k991619-fountain-infusion-catheter-and-fda-510k.jpg K991619 - FOUNTAIN Infusion Catheter and Occluding Guide Wire K991619 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jun 1999. https://www.510kdatabase.net/k991795/ 1999-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k991795-immulite-turbo-troponin-i-models-fda-510k.jpg K991795 - IMMULITE TURBO TROPONIN I, MODELS LSKTI1, LSKTI5 K991795 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jun 1999. https://www.510kdatabase.net/k991796/ 1999-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k991796-immulite-turbo-myoglobin-models-lskmy1-fda-510k.jpg K991796 - IMMULITE TURBO MYOGLOBIN, MODELS LSKMY1, LSKMY5 K991796 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jun 1999. https://www.510kdatabase.net/k991797/ 1999-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k991797-immulite-turbo-ck-mb-models-lskcp1-fda-510k.jpg K991797 - IMMULITE TURBO CK-MB, MODELS LSKCP1, LSKCP5 K991797 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jun 1999. https://www.510kdatabase.net/k983629/ 1999-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k983629-rpm-respiratory-gating-system-fda-510k.jpg K983629 - RPM RESPIRATORY GATING SYSTEM K983629 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Jun 1999. https://www.510kdatabase.net/k983296/ 1999-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k983296-auto-suture-abbi-system-fda-510k.jpg K983296 - AUTO SUTURE ABBI SYSTEM K983296 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Jun 1999. https://www.510kdatabase.net/k991069/ 1999-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k991069-ksea-neuro-fiberscope-fda-510k.jpg K991069 - KSEA NEURO-FIBERSCOPE K991069 is a FDA 510(k) cleared neurology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jun 1999. https://www.510kdatabase.net/k991167/ 1999-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k991167-steris-smoke-evacuation-system-fda-510k.jpg K991167 - STERIS SMOKE EVACUATION SYSTEM K991167 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Jun 1999. https://www.510kdatabase.net/k991710/ 1999-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k991710-ssa-370apowervision-6000-fda-510k.jpg K991710 - SSA-370A/POWERVISION 6000 K991710 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Jun 1999. https://www.510kdatabase.net/k990922/ 1999-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k990922-osteonics-spinal-system-versatile-fda-510k.jpg K990922 - OSTEONICS SPINAL SYSTEM VERSATILE CROSS CONNECTOR K990922 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jun 1999. https://www.510kdatabase.net/k991552/ 1999-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k991552-synthes-pediatric-rod-system-fda-510k.jpg K991552 - SYNTHES PEDIATRIC ROD SYSTEM K991552 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jun 1999. https://www.510kdatabase.net/k991051/ 1999-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k991051-ksea-epiduroscope-fda-510k.jpg K991051 - KSEA EPIDUROSCOPE K991051 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jun 1999. https://www.510kdatabase.net/k991123/ 1999-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k991123-perfecta-rs-lateralized-hip-stem-fda-510k.jpg K991123 - PERFECTA RS LATERALIZED HIP STEM, BRIDGE HIP SYSTEM K991123 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jun 1999. https://www.510kdatabase.net/k991181/ 1999-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k991181-modification-of-n-protein-standard-sl-fda-510k.jpg K991181 - MODIFICATION OF N PROTEIN STANDARD SL K991181 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Jun 1999. https://www.510kdatabase.net/k991372/ 1999-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k991372-crp-fda-510k.jpg K991372 - CRP K991372 is a FDA 510(k) cleared immunology medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1999. https://www.510kdatabase.net/k991175/ 1999-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k991175-modification-to-alcyon-direct-bilirubin-fda-510k.jpg K991175 - MODIFICATION TO ALCYON DIRECT BILIRUBIN K991175 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared May 1999. https://www.510kdatabase.net/k991648/ 1999-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k991648-reusable-contour-ii-nasal-mask-fda-510k.jpg K991648 - REUSABLE CONTOUR II NASAL MASK K991648 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared May 1999. https://www.510kdatabase.net/k991661/ 1999-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k991661-siemens-medical-information-bus-mib-fda-510k.jpg K991661 - SIEMENS MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER K991661 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 1999. https://www.510kdatabase.net/k990753/ 1999-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k990753-grac-high-dose-rate-hdr-remote-fda-510k.jpg K990753 - GRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER K990753 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cook, Inc.. Cleared May 1999. https://www.510kdatabase.net/k983805/ 1999-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k983805-the-aptus-automated-application-of-the-fda-510k.jpg K983805 - THE APTUS (AUTOMATED) APPLICATION OF THE RUBELLA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO K983805 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared May 1999. https://www.510kdatabase.net/k984120/ 1999-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k984120-the-aptusautomated-application-of-the-fda-510k.jpg K984120 - THE APTUS(AUTOMATED) APPLICATION OF THE HSV-2 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH K984120 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared May 1999. https://www.510kdatabase.net/k984135/ 1999-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k984135-the-aptus-automated-application-of-the-fda-510k.jpg K984135 - THE APTUS (AUTOMATED) APPLICATION OF THE HSV-1 IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR K984135 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared May 1999. https://www.510kdatabase.net/k991673/ 1999-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k991673-cordis-tempo-angiography-catheter-fda-510k.jpg K991673 - CORDIS TEMPO ANGIOGRAPHY CATHETER K991673 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared May 1999. https://www.510kdatabase.net/k990574/ 1999-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k990574-stick-on-disposable-nasal-mask-model-fda-510k.jpg K990574 - STICK-ON DISPOSABLE NASAL MASK, MODEL 312174, 1001964 K990574 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared May 1999. https://www.510kdatabase.net/k991428/ 1999-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k991428-ascent-knee-system-fda-510k.jpg K991428 - ASCENT KNEE SYSTEM K991428 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared May 1999. https://www.510kdatabase.net/k983831/ 1999-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k983831-vectorvision2-fda-510k.jpg K983831 - VECTORVISION2 K983831 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared May 1999. https://www.510kdatabase.net/k984407/ 1999-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k984407-bipap-harmony-st-model-1001445-fda-510k.jpg K984407 - BIPAP HARMONY S/T, MODEL 1001445 K984407 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared May 1999. https://www.510kdatabase.net/k991182/ 1999-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k991182-modification-of-nt-protein-control-sl-fda-510k.jpg K991182 - MODIFICATION OF N/T PROTEIN CONTROL SL K991182 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared May 1999. https://www.510kdatabase.net/k991461/ 1999-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k991461-osteonics-scorpio-total-knee-relaxed-fda-510k.jpg K991461 - OSTEONICS SCORPIO TOTAL KNEE RELAXED BACK P/S TIBIAL BEARING INSERT K991461 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared May 1999. https://www.510kdatabase.net/k991627/ 1999-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k991627-wallaby-3-phototherapy-system-model-3600-fda-510k.jpg K991627 - WALLABY 3 PHOTOTHERAPY SYSTEM, MODEL 3600 K991627 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Respironics, Inc.. Cleared May 1999. https://www.510kdatabase.net/k991298/ 1999-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k991298-bone-mulch-screw-system-fda-510k.jpg K991298 - BONE MULCH SCREW SYSTEM K991298 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared May 1999. https://www.510kdatabase.net/k983575/ 1999-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k983575-accutorr-plus-non-invasive-blood-fda-510k.jpg K983575 - ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR, MODEL # 0998-00-0117-XX K983575 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared May 1999. https://www.510kdatabase.net/k991094/ 1999-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k991094-immulite-2000-anti-tg-ab-model-l2ktg2-fda-510k.jpg K991094 - IMMULITE 2000 ANTI-TG AB, MODEL L2KTG2, L2KTG6 K991094 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared May 1999. https://www.510kdatabase.net/k991096/ 1999-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k991096-immulite-2000-anti-tpo-ab-model-l2kt02-fda-510k.jpg K991096 - IMMULITE 2000 ANTI-TPO AB, MODEL L2KT02, L2KT06 K991096 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared May 1999. https://www.510kdatabase.net/k991501/ 1999-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k991501-acclaim-infusion-pump-fda-510k.jpg K991501 - ACCLAIM INFUSION PUMP K991501 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared May 1999. https://www.510kdatabase.net/k990426/ 1999-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k990426-calcium-scoring-fda-510k.jpg K990426 - CALCIUM SCORING K990426 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 1999. https://www.510kdatabase.net/k990774/ 1999-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k990774-abbott-architect-cea-fda-510k.jpg K990774 - ABBOTT ARCHITECT CEA K990774 is a FDA 510(k) cleared immunology medical device. Manufacturer: Abbott Laboratories. Cleared May 1999. https://www.510kdatabase.net/k991136/ 1999-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k991136-b-2-microglobulin-immunological-test-fda-510k.jpg K991136 - B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM K991136 is a FDA 510(k) cleared immunology medical device. Manufacturer: Olympus America, Inc.. Cleared May 1999. https://www.510kdatabase.net/k990684/ 1999-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k990684-modification-of-sas-serumurine-hcg-fda-510k.jpg K990684 - MODIFICATION OF SAS SERUM/URINE HCG K990684 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sa Scientific, Inc.. Cleared May 1999. https://www.510kdatabase.net/k990741/ 1999-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k990741-sas-one-step-pregnancy-fda-510k.jpg K990741 - SAS ONE-STEP PREGNANCY K990741 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sa Scientific, Inc.. Cleared May 1999. https://www.510kdatabase.net/k990756/ 1999-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k990756-flow-line-fda-510k.jpg K990756 - FLOW LINE K990756 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared May 1999. https://www.510kdatabase.net/k972774/ 1999-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k972774-gas-plasma-sterilization-fda-510k.jpg K972774 - GAS PLASMA STERILIZATION K972774 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zimmer, Inc.. Cleared May 1999. https://www.510kdatabase.net/k991193/ 1999-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k991193-sas-hcg-check-fda-510k.jpg K991193 - SAS HCG-CHECK K991193 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sa Scientific, Inc.. Cleared May 1999. https://www.510kdatabase.net/k983698/ 1999-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k983698-modification-to-abuscreen-online-fda-510k.jpg K983698 - MODIFICATION TO ABUSCREEN ONLINE BARBITURATES K983698 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared May 1999. https://www.510kdatabase.net/k990704/ 1999-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k990704-array-360-system-c-reactive-protein-fda-510k.jpg K990704 - ARRAY 360 SYSTEM C-REACTIVE PROTEIN (CRP MPE) REAGENT K990704 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared May 1999. https://www.510kdatabase.net/k983036/ 1999-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k983036-single-axle-total-elbow-fda-510k.jpg K983036 - SINGLE AXLE TOTAL ELBOW K983036 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Apr 1999. https://www.510kdatabase.net/k984194/ 1999-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k984194-hp-m2376a-device-link-system-fda-510k.jpg K984194 - HP M2376A DEVICE LINK SYSTEM K984194 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Apr 1999. https://www.510kdatabase.net/k984375/ 1999-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k984375-osteonics-spinal-system-sacral-offset-fda-510k.jpg K984375 - OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLY K984375 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Apr 1999. https://www.510kdatabase.net/k990631/ 1999-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k990631-cordia-palmaz-corinthian-transhepatic-fda-510k.jpg K990631 - CORDIA PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, MODEL PC125BPS, PC126BPS, PC127BPS,PC128BPS, PC K990631 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Apr 1999. https://www.510kdatabase.net/k991223/ 1999-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k991223-absorbable-surgical-gut-suture-plain-fda-510k.jpg K991223 - ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC AND SOFTCAT ABSORBABLE SURGICAL GUT SUTURE, PLAIN AND CHRONIC K991223 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Apr 1999. https://www.510kdatabase.net/k990866/ 1999-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k990866-quinton-medtrack-cr-plus-treadmill-fda-510k.jpg K990866 - QUINTON MEDTRACK CR PLUS TREADMILL K990866 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Quinton, Inc.. Cleared Apr 1999. https://www.510kdatabase.net/k991135/ 1999-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k991135-soft-tissue-suture-washer-fda-510k.jpg K991135 - SOFT TISSUE SUTURE WASHER K991135 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Apr 1999. https://www.510kdatabase.net/k990610/ 1999-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k990610-abbott-tumor-marker-mcc-lyophilized-fda-510k.jpg K990610 - ABBOTT TUMOR MARKER-MCC (LYOPHILIZED), MODEL 6E21-10 K990610 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Apr 1999. https://www.510kdatabase.net/k991277/ 1999-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k991277-modification-to-immulite-myoglobin-fda-510k.jpg K991277 - MODIFICATION TO IMMULITE MYOGLOBIN, MODEL LKMY1, LKMY5 K991277 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Apr 1999. https://www.510kdatabase.net/k983732/ 1999-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k983732-thorax-fd-and-multix-fd-fda-510k.jpg K983732 - THORAX FD AND MULTIX FD K983732 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 1999. https://www.510kdatabase.net/k990858/ 1999-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k990858-lypochek-coagulation-control-model-nos-fda-510k.jpg K990858 - LYPOCHEK COAGULATION CONTROL, MODEL NOS. 787, 788, 789 K990858 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bio-Rad. Cleared Apr 1999. https://www.510kdatabase.net/k990199/ 1999-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k990199-smartrecorder-model-2500-fda-510k.jpg K990199 - SMARTRECORDER, MODEL 2500 K990199 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Apr 1999. https://www.510kdatabase.net/k983948/ 1999-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k983948-beacon-model-211060-fda-510k.jpg K983948 - BEACON, MODEL 211060 K983948 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Apr 1999. https://www.510kdatabase.net/k990031/ 1999-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k990031-nihon-kohden-ecg-9010k-and-ecg-9020k-fda-510k.jpg K990031 - NIHON KOHDEN ECG-9010K AND ECG-9020K CARDIOFAX GEM AND ACCESSORIES K990031 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Apr 1999. https://www.510kdatabase.net/k990147/ 1999-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k990147-bipolar-forceps-kleppinger-insert-fda-510k.jpg K990147 - BIPOLAR FORCEPS, KLEPPINGER INSERT, MODEL #'S 8393.741,8393.771,8394.741,8394.771 K990147 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Apr 1999. https://www.510kdatabase.net/k990824/ 1999-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k990824-revised-c-reactive-protein-calibrator-fda-510k.jpg K990824 - REVISED C-REACTIVE PROTEIN CALIBRATOR K990824 is a FDA 510(k) cleared immunology medical device. Manufacturer: Dade Behring, Inc.. Cleared Apr 1999. https://www.510kdatabase.net/k990825/ 1999-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k990825-revised-c-reactive-protein-rcrp-flex-fda-510k.jpg K990825 - REVISED C-REACTIVE PROTEIN (RCRP) FLEX REAGENT CARTRIDGE K990825 is a FDA 510(k) cleared immunology medical device. Manufacturer: Dade Behring, Inc.. Cleared Apr 1999. https://www.510kdatabase.net/k990928/ 1999-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k990928-lyphocheck-urine-metals-control-item-fda-510k.jpg K990928 - LYPHOCHECK URINE METALS CONTROL, ITEM NO.400, 405 K990928 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bio-Rad. Cleared Apr 1999. https://www.510kdatabase.net/k984222/ 1999-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k984222-quanta-lite-lyme-igg-elisa-fda-510k.jpg K984222 - QUANTA LITE LYME IGG ELISA K984222 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Apr 1999. https://www.510kdatabase.net/k984234/ 1999-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k984234-quanta-lite-lyme-igm-elisa-fda-510k.jpg K984234 - QUANTA LITE LYME IGM ELISA K984234 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Apr 1999. https://www.510kdatabase.net/k984504/ 1999-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k984504-nihon-kohden-ecg-9110k-and-ecg-9130k-fda-510k.jpg K984504 - NIHON KOHDEN ECG-9110K AND ECG-9130K CARDIOFAX Q AND ACCESSORIES K984504 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Apr 1999. https://www.510kdatabase.net/k990399/ 1999-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k990399-ontrak-testcup-m2k-model-cat-11-1849-8-fda-510k.jpg K990399 - ONTRAK TESTCUP M2K, MODEL CAT. 11 1849 8 K990399 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Apr 1999. https://www.510kdatabase.net/k990409/ 1999-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k990409-ontrak-teststik-for-morphine-2000-m2k-fda-510k.jpg K990409 - ONTRAK TESTSTIK FOR MORPHINE 2000 (M2K) K990409 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Apr 1999. https://www.510kdatabase.net/k990361/ 1999-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k990361-headed-bio-absorbable-corkscrew-model-fda-510k.jpg K990361 - HEADED BIO-ABSORBABLE CORKSCREW MODEL #AR-1921BU K990361 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Apr 1999. https://www.510kdatabase.net/k990414/ 1999-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k990414-smith-nephew-handport-system-fda-510k.jpg K990414 - SMITH & NEPHEW HANDPORT SYSTEM K990414 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Apr 1999. https://www.510kdatabase.net/k990594/ 1999-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k990594-integra-reagent-cassette-for-fda-510k.jpg K990594 - INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1 K990594 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Apr 1999. https://www.510kdatabase.net/k990595/ 1999-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k990595-integra-reagent-cassette-for-fda-510k.jpg K990595 - INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN B K990595 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Apr 1999. https://www.510kdatabase.net/k990418/ 1999-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k990418-ontrak-testcup-er-m2k-fda-510k.jpg K990418 - ONTRAK TESTCUP-ER M2K K990418 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Apr 1999. https://www.510kdatabase.net/k984059/ 1999-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k984059-angiocath-autoguard-catheter-insyte-fda-510k.jpg K984059 - ANGIOCATH AUTOGUARD CATHETER, INSYTE AUTOGUARD CATHETER K984059 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1999. https://www.510kdatabase.net/k990827/ 1999-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k990827-microplate-neonatal-galt-assay-fda-510k.jpg K990827 - MICROPLATE NEONATAL GALT ASSAY K990827 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Apr 1999. https://www.510kdatabase.net/k984526/ 1999-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k984526-acuseal-cardiovascular-patch-fda-510k.jpg K984526 - ACUSEAL CARDIOVASCULAR PATCH K984526 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Apr 1999. https://www.510kdatabase.net/k990302/ 1999-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k990302-il-test-lac-screen-claims-added-to-acl-fda-510k.jpg K990302 - IL TEST LAC SCREEN (CLAIMS ADDED TO ACL FUTURA), IL TEST LAC CONFIRM (CLAIMS ADDAD TO ACL FUTURA) K990302 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Apr 1999. https://www.510kdatabase.net/k990587/ 1999-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k990587-abbott-liquid-rf-control-models-2e04-fda-510k.jpg K990587 - ABBOTT LIQUID RF CONTROL, MODELS 2E04-01, 2E05-01, 2E06-01 K990587 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Apr 1999. https://www.510kdatabase.net/k990888/ 1999-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k990888-modification-to-liquichek-spinal-fluid-fda-510k.jpg K990888 - MODIFICATION TO LIQUICHEK SPINAL FLUID CONTROL, ITEM NOS. 751, 752 K990888 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Apr 1999. https://www.510kdatabase.net/k990886/ 1999-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k990886-immulite-c-reactive-protein-model-fda-510k.jpg K990886 - IMMULITE C-REACTIVE PROTEIN, MODEL LKCR1, LKCR5 K990886 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Apr 1999. https://www.510kdatabase.net/k990491/ 1999-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k990491-angio-ct-miyabi-fda-510k.jpg K990491 - ANGIO-CT MIYABI K990491 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 1999. https://www.510kdatabase.net/k990004/ 1999-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k990004-dci-endoscope-fda-510k.jpg K990004 - DCI ENDOSCOPE K990004 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Apr 1999. https://www.510kdatabase.net/k990726/ 1999-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k990726-envy-guiding-catheter-fda-510k.jpg K990726 - ENVY GUIDING CATHETER K990726 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Apr 1999. https://www.510kdatabase.net/k990188/ 1999-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k990188-intuitive-surgical-stereo-view-fda-510k.jpg K990188 - INTUITIVE SURGICAL STEREO VIEW ENDOSCOPIC SYSTEM, MODEL SVS-1 K990188 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Apr 1999. https://www.510kdatabase.net/k990951/ 1999-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k990951-maxon-sterile-synthetic-absorbable-fda-510k.jpg K990951 - MAXON** STERILE, SYNTHETIC, ABSORBABLE SUTURE K990951 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Apr 1999. https://www.510kdatabase.net/k990952/ 1999-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k990952-novafil-and-vascufil-sterile-synthetic-fda-510k.jpg K990952 - NOVAFIL** AND VASCUFIL** STERILE SYNTHETIC NON-ABSORBABLE SUTURES K990952 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Apr 1999. https://www.510kdatabase.net/k990251/ 1999-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k990251-dgtx-flex-reagent-cartridge-model-df36-fda-510k.jpg K990251 - DGTX FLEX REAGENT CARTRIDGE, MODEL DF36 K990251 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Dade Behring, Inc.. Cleared Mar 1999. https://www.510kdatabase.net/k990424/ 1999-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k990424-abbott-liquid-immunology-control-fda-510k.jpg K990424 - ABBOTT LIQUID IMMUNOLOGY CONTROL MODELS 2E01-01/2E02-01/2E03-01 K990424 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Mar 1999. https://www.510kdatabase.net/k990608/ 1999-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k990608-architect-cea-mastercheck-model-6co2-05-fda-510k.jpg K990608 - ARCHITECT CEA MASTERCHECK, MODEL 6CO2-05 K990608 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Mar 1999. https://www.510kdatabase.net/k990708/ 1999-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k990708-titanium-versalok-fda-510k.jpg K990708 - TITANIUM VERSALOK K990708 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Mar 1999. https://www.510kdatabase.net/k990860/ 1999-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k990860-viewpoint-microscope-option-fda-510k.jpg K990860 - VIEWPOINT MICROSCOPE OPTION K990860 is a FDA 510(k) cleared neurology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Mar 1999. https://www.510kdatabase.net/k990868/ 1999-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k990868-viewpoint-passive-tool-option-fda-510k.jpg K990868 - VIEWPOINT PASSIVE TOOL OPTION K990868 is a FDA 510(k) cleared neurology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Mar 1999. https://www.510kdatabase.net/k990050/ 1999-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k990050-uretero-renoscope-model-8706402-fda-510k.jpg K990050 - URETERO-RENOSCOPE, MODEL 8706.402, INSERTION SHEATH, MODEL 8706.042 K990050 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Mar 1999. https://www.510kdatabase.net/k990204/ 1999-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k990204-gliadin-igg-elisa-test-system-fda-510k.jpg K990204 - GLIADIN IGG ELISA TEST SYSTEM K990204 is a FDA 510(k) cleared immunology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Mar 1999. https://www.510kdatabase.net/k990207/ 1999-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k990207-gliadin-iga-elisa-test-system-fda-510k.jpg K990207 - GLIADIN IGA ELISA TEST SYSTEM K990207 is a FDA 510(k) cleared immunology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Mar 1999. https://www.510kdatabase.net/k982798/ 1999-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k982798-osteonics-anterior-cervical-fda-510k.jpg K982798 - OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEM K982798 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Mar 1999. https://www.510kdatabase.net/k990551/ 1999-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k990551-igg-flex-reagent-cartridge-fda-510k.jpg K990551 - IGG FLEX REAGENT CARTRIDGE K990551 is a FDA 510(k) cleared immunology medical device. Manufacturer: Dade Behring, Inc.. Cleared Mar 1999. https://www.510kdatabase.net/k990552/ 1999-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k990552-immunoglobulin-a-test-system-fda-510k.jpg K990552 - IMMUNOGLOBULIN A TEST SYSTEM K990552 is a FDA 510(k) cleared immunology medical device. Manufacturer: Dade Behring, Inc.. Cleared Mar 1999. https://www.510kdatabase.net/k984138/ 1999-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k984138-aptus-automated-application-for-the-b-fda-510k.jpg K984138 - APTUS (AUTOMATED) APPLICATION FOR THE B. BURGDORFERI ANTIBODY ELISA TEST SYSTEM K984138 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Mar 1999. https://www.510kdatabase.net/k990291/ 1999-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k990291-lactosorb-bone-pin-fda-510k.jpg K990291 - LACTOSORB BONE PIN K990291 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Mar 1999. https://www.510kdatabase.net/k990090/ 1999-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k990090-dafilon-nonabsorbable-polyamide-fda-510k.jpg K990090 - DAFILON NONABSORBABLE POLYAMIDE SURGICAL SUTURE K990090 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Mar 1999. https://www.510kdatabase.net/k990334/ 1999-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k990334-ksea-endoscope-holder-fda-510k.jpg K990334 - KSEA ENDOSCOPE HOLDER K990334 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Mar 1999. https://www.510kdatabase.net/k990393/ 1999-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k990393-architect-progesterone-mastercheck-fda-510k.jpg K990393 - ARCHITECT PROGESTERONE MASTERCHECK MODEL #6C26-05 K990393 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Mar 1999. https://www.510kdatabase.net/k990460/ 1999-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k990460-calibrator-for-automated-systems-cfas-fda-510k.jpg K990460 - CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) K990460 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Mar 1999. https://www.510kdatabase.net/k990553/ 1999-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k990553-igm-flex-reagent-cartridge-fda-510k.jpg K990553 - IGM FLEX REAGENT CARTRIDGE K990553 is a FDA 510(k) cleared immunology medical device. Manufacturer: Dade Behring, Inc.. Cleared Mar 1999. https://www.510kdatabase.net/k990554/ 1999-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k990554-dimension-special-protein-calibrator-fda-510k.jpg K990554 - DIMENSION SPECIAL PROTEIN CALIBRATOR K990554 is a FDA 510(k) cleared immunology medical device. Manufacturer: Dade Behring, Inc.. Cleared Mar 1999. https://www.510kdatabase.net/k990134/ 1999-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k990134-multislice-upgrade-kit-for-aquilion-ct-fda-510k.jpg K990134 - MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER, TSX-101A (AQUILION,MULTI) K990134 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Mar 1999. https://www.510kdatabase.net/k990563/ 1999-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k990563-siemens-sc-8000-bedside-monitor-with-fda-510k.jpg K990563 - SIEMENS SC 8000 BEDSIDE MONITOR WITH ADVANCED COMMUNICATION OPTION K990563 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 1999. https://www.510kdatabase.net/k990720/ 1999-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k990720-sas-hcg-serum-controls-fda-510k.jpg K990720 - SAS HCG SERUM CONTROLS K990720 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sa Scientific, Inc.. Cleared Mar 1999. https://www.510kdatabase.net/k990755/ 1999-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k990755-sas-hcg-urine-controls-fda-510k.jpg K990755 - SAS HCG URINE CONTROLS K990755 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sa Scientific, Inc.. Cleared Mar 1999. https://www.510kdatabase.net/k983336/ 1999-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k983336-pathodx-respiratory-virus-panel-model-fda-510k.jpg K983336 - PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1 K983336 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Mar 1999. https://www.510kdatabase.net/k983656/ 1999-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k983656-hsv-1-andor-2-igm-elisa-test-system-fda-510k.jpg K983656 - HSV-1 AND/OR -2 IGM ELISA TEST SYSTEM K983656 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Mar 1999. https://www.510kdatabase.net/k990317/ 1999-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k990317-abbot-liquid-urine-chemistry-control-fda-510k.jpg K990317 - ABBOT LIQUID URINE CHEMISTRY CONTROL, MODEL 1E96-01/1E97-01 K990317 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Mar 1999. https://www.510kdatabase.net/k990394/ 1999-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k990394-abbott-lyophilized-assayed-chemistry-fda-510k.jpg K990394 - ABBOTT LYOPHILIZED ASSAYED CHEMISTRY CONTROL MODELS #1E86-02/#1E87-02 K990394 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Mar 1999. https://www.510kdatabase.net/k984521/ 1999-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k984521-riwo-drive-system-2302-with-generator-fda-510k.jpg K984521 - RIWO DRIVE SYSTEM 2302 WITH GENERATOR, SMALL MOTOR HANDLES, 8563.111, 8563.351 K984521 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Mar 1999. https://www.510kdatabase.net/k984534/ 1999-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k984534-preclude-acuseal-dura-substitute-fda-510k.jpg K984534 - PRECLUDE ACUSEAL DURA SUBSTITUTE K984534 is a FDA 510(k) cleared neurology medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Mar 1999. https://www.510kdatabase.net/k990089/ 1999-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k990089-silkam-nonabsorbable-silk-surgical-fda-510k.jpg K990089 - SILKAM NONABSORBABLE SILK SURGICAL SUTURE K990089 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Mar 1999. https://www.510kdatabase.net/k990152/ 1999-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k990152-osteo-ic-retrogradeantegrade-femoral-fda-510k.jpg K990152 - OSTEO IC RETROGRADE/ANTEGRADE FEMORAL NAIL NUT AND WASHER K990152 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Mar 1999. https://www.510kdatabase.net/k990391/ 1999-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k990391-abbott-lyophilized-assayed-chemistry-fda-510k.jpg K990391 - ABBOTT LYOPHILIZED ASSAYED CHEMISTRY CONTROL 3 MODEL #4E39-01 K990391 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Mar 1999. https://www.510kdatabase.net/k990598/ 1999-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k990598-osteonics-solar-shoulder-humeral-fda-510k.jpg K990598 - OSTEONICS SOLAR SHOULDER HUMERAL BEARING HEAD K990598 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Mar 1999. https://www.510kdatabase.net/k990805/ 1999-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k990805-modification-to-7f-hydrolyser-fda-510k.jpg K990805 - MODIFICATION TO 7F HYDROLYSER THROMBECTOMY CATHETER K990805 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Mar 1999. https://www.510kdatabase.net/k982466/ 1999-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k982466-immulite-thyroglobulin-model-lkty-fda-510k.jpg K982466 - IMMULITE THYROGLOBULIN MODEL LKTY K982466 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Mar 1999. https://www.510kdatabase.net/k982468/ 1999-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k982468-immulite-2000-thyroglobulin-model-l2kty-fda-510k.jpg K982468 - IMMULITE 2000 THYROGLOBULIN MODEL L2KTY K982468 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Mar 1999. https://www.510kdatabase.net/k983843/ 1999-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k983843-bio-button-65mm-bio-button-8mm-model-s-fda-510k.jpg K983843 - BIO-BUTTON 6.5MM, BIO-BUTTON 8MM, MODEL #'S AR-2236B & AR-2238B K983843 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Mar 1999. https://www.510kdatabase.net/k990369/ 1999-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k990369-synergy-cemented-hip-stem-fda-510k.jpg K990369 - SYNERGY CEMENTED HIP STEM K990369 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Mar 1999. https://www.510kdatabase.net/k983171/ 1999-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k983171-constellation-multiple-electrode-fda-510k.jpg K983171 - CONSTELLATION MULTIPLE ELECTRODE PACING AND RECORDING SYSTEM K983171 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Mar 1999. https://www.510kdatabase.net/k981996/ 1999-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k981996-titanium-femoral-component-fda-510k.jpg K981996 - TITANIUM FEMORAL COMPONENT K981996 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Mar 1999. https://www.510kdatabase.net/k984271/ 1999-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k984271-modification-of-maxima-forte-hollow-fda-510k.jpg K984271 - MODIFICATION OF MAXIMA FORTE' HOLLOW FIBER OXYGENATOR WITH BALANCE BIOCOMPATIBLE SURFACE WITH PLASMA RESISTENT FIBER (M0 K984271 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Mar 1999. https://www.510kdatabase.net/k990282/ 1999-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k990282-abbott-liquid-assayed-chemistry-fda-510k.jpg K990282 - ABBOTT LIQUID ASSAYED CHEMISTRY CONTROL, MODEL 1E81-01/1E82-01 K990282 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Mar 1999. https://www.510kdatabase.net/k990514/ 1999-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k990514-modification-of-bard-quantum-cvr-model-fda-510k.jpg K990514 - MODIFICATION OF BARD QUANTUM CVR, MODEL H-6770VR K990514 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 1999. https://www.510kdatabase.net/k990035/ 1999-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k990035-rf-fda-510k.jpg K990035 - RF K990035 is a FDA 510(k) cleared immunology medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1999. https://www.510kdatabase.net/k982952/ 1999-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k982952-imfast-fda-510k.jpg K982952 - IMFAST K982952 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 1999. https://www.510kdatabase.net/k984607/ 1999-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k984607-panoview-plus-optic-with-27mm-diameter-fda-510k.jpg K984607 - PANOVIEW PLUS OPTIC WITH 2.7MM DIAMETER, MODEL 8672.XXX, PANOVIEW PLUS OPTIC WITH 1.9MM DIAMETER, MODEL 8686.XXX K984607 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Mar 1999. https://www.510kdatabase.net/k984623/ 1999-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k984623-maxim-removable-molded-poly-tibia-fda-510k.jpg K984623 - MAXIM REMOVABLE MOLDED POLY TIBIA K984623 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Mar 1999. https://www.510kdatabase.net/k990295/ 1999-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k990295-bone-anchor-system-iii-bas-iii-fda-510k.jpg K990295 - BONE ANCHOR SYSTEM III (BAS III) K990295 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Boston Scientific Corp. Cleared Mar 1999. https://www.510kdatabase.net/k983071/ 1999-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k983071-bilichek-non-invasive-bilirubin-analyzer-fda-510k.jpg K983071 - BILICHEK NON-INVASIVE BILIRUBIN ANALYZER K983071 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Respironics, Inc.. Cleared Mar 1999. https://www.510kdatabase.net/k990490/ 1999-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k990490-ssa-320a-just-vision-200-ssa-325a-just-fda-510k.jpg K990490 - SSA-320A JUST VISION 200/ SSA-325A JUST VISION K990490 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Mar 1999. https://www.510kdatabase.net/k984550/ 1999-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k984550-pre-threaded-endobutton-fda-510k.jpg K984550 - PRE-THREADED ENDOBUTTON K984550 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Mar 1999. https://www.510kdatabase.net/k983534/ 1999-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k983534-7f-hydrolyser-thrombectomy-catheter-fda-510k.jpg K983534 - 7F HYDROLYSER THROMBECTOMY CATHETER K983534 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Feb 1999. https://www.510kdatabase.net/k990222/ 1999-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k990222-immulite-hcg-model-lkcg1-lccg5-fda-510k.jpg K990222 - IMMULITE HCG, MODEL LKCG1, LCCG5, IMMULITE 2000 HCG, MODEL L2KCG2, L2KCG6 K990222 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Feb 1999. https://www.510kdatabase.net/k990377/ 1999-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k990377-ontrak-testcup-m2k-and-ontrak-teststik-fda-510k.jpg K990377 - ONTRAK TESTCUP M2K AND ONTRAK TESTSTIK POSITIVE CONTROL, MODEL 11 18544, ONTRAK TESTCUP M2K AND ONTRAK TESTSTICK NEGATIV K990377 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Feb 1999. https://www.510kdatabase.net/k990143/ 1999-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k990143-gluma-one-bond-fda-510k.jpg K990143 - GLUMA ONE BOND K990143 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Feb 1999. https://www.510kdatabase.net/k983834/ 1999-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k983834-echelon-hip-stem-fda-510k.jpg K983834 - ECHELON HIP STEM K983834 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Feb 1999. https://www.510kdatabase.net/k984417/ 1999-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k984417-bipolar-grasping-forceps-biq-fda-510k.jpg K984417 - BIPOLAR GRASPING FORCEPS BIQ+ K984417 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Olympus America, Inc.. Cleared Feb 1999. https://www.510kdatabase.net/k984432/ 1999-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k984432-dall-miles-cable-grip-a-grip-fda-510k.jpg K984432 - DALL-MILES CABLE GRIP (A-GRIP) K984432 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Feb 1999. https://www.510kdatabase.net/k984585/ 1999-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k984585-osteonics-10-unipolar-adaptor-sleeve-fda-510k.jpg K984585 - OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVE K984585 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Feb 1999. https://www.510kdatabase.net/k990400/ 1999-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k990400-linear-array-transducermodel-hp-21376-fda-510k.jpg K990400 - LINEAR ARRAY TRANSDUCER,MODEL HP 21376, M2410A ULTRASOUND IMAGING SYSTEM K990400 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Feb 1999. https://www.510kdatabase.net/k982363/ 1999-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k982363-oasis-thrombectomy-catheter-system-fda-510k.jpg K982363 - OASIS THROMBECTOMY CATHETER SYSTEM K982363 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Feb 1999. https://www.510kdatabase.net/k984220/ 1999-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k984220-modification-of-prolene-polypropylene-fda-510k.jpg K984220 - MODIFICATION OF PROLENE (POLYPROPYLENE) HERNIA SYSTEM, NONABSORBABLE SYNTHETIC SURGICAL MESH K984220 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Feb 1999. https://www.510kdatabase.net/k990337/ 1999-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k990337-ontrak-testcup-5-m2k-fda-510k.jpg K990337 - ONTRAK TESTCUP-5 M2K K990337 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostics Corp.. Cleared Feb 1999. https://www.510kdatabase.net/k990373/ 1999-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k990373-fact-plus-one-step-pregnancy-test-fda-510k.jpg K990373 - FACT PLUS ONE STEP PREGNANCY TEST K990373 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Feb 1999. https://www.510kdatabase.net/k983139/ 1999-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k983139-signa-15t-phosphorus-p-transmitreceive-fda-510k.jpg K983139 - SIGNA 1.5T PHOSPHORUS (P) TRANSMIT/RECEIVE FLEX COIL K983139 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Feb 1999. https://www.510kdatabase.net/k984381/ 1999-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k984381-buretrol-solution-sets-fda-510k.jpg K984381 - BURETROL SOLUTION SETS K984381 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Feb 1999. https://www.510kdatabase.net/k984296/ 1999-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k984296-lateralized-intergral-porous-primary-fda-510k.jpg K984296 - LATERALIZED INTERGRAL POROUS PRIMARY FEMORAL COMPONENT K984296 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Feb 1999. https://www.510kdatabase.net/k984498/ 1999-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k984498-synthes-usa-articulating-distal-radius-fda-510k.jpg K984498 - SYNTHES (USA) ARTICULATING DISTAL RADIUS (ADRF) SYSTEM K984498 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Feb 1999. https://www.510kdatabase.net/k990032/ 1999-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k990032-modular-protusio-cup-fda-510k.jpg K990032 - MODULAR PROTUSIO CUP K990032 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Feb 1999. https://www.510kdatabase.net/k990203/ 1999-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k990203-osteonics-primary-secur-fit-plus-hip-fda-510k.jpg K990203 - OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS K990203 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Feb 1999. https://www.510kdatabase.net/k990339/ 1999-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k990339-sonos-5500-imaging-system-m2424a-fda-510k.jpg K990339 - SONOS 5500 IMAGING SYSTEM M2424A VERSION B.O K990339 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Feb 1999. https://www.510kdatabase.net/k983070/ 1999-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k983070-ck-fda-510k.jpg K983070 - CK K983070 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Feb 1999. https://www.510kdatabase.net/k990255/ 1999-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k990255-dimension-drug-calibrator-ii-model-dc49b-fda-510k.jpg K990255 - DIMENSION DRUG CALIBRATOR II, MODEL DC49B K990255 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Dade Behring, Inc.. Cleared Feb 1999. https://www.510kdatabase.net/k982333/ 1999-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k982333-modification-to-uldall-double-lumen-fda-510k.jpg K982333 - MODIFICATION TO ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET AND TRAY K982333 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook, Inc.. Cleared Feb 1999. https://www.510kdatabase.net/k984109/ 1999-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k984109-aesculap-axial-clip-applier-fda-510k.jpg K984109 - AESCULAP AXIAL CLIP APPLIER K984109 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Feb 1999. https://www.510kdatabase.net/k984408/ 1999-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k984408-130-modified-integral-femoral-component-fda-510k.jpg K984408 - 130 MODIFIED INTEGRAL FEMORAL COMPONENT K984408 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Feb 1999. https://www.510kdatabase.net/k983702/ 1999-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k983702-modification-to-abuscreen-online-for-fda-510k.jpg K983702 - MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINES K983702 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Feb 1999. https://www.510kdatabase.net/k984154/ 1999-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k984154-apf-porous-coated-line-extension-fda-510k.jpg K984154 - APF POROUS COATED LINE EXTENSION K984154 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Feb 1999. https://www.510kdatabase.net/k984574/ 1999-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k984574-infinity-glucose-reagent-fda-510k.jpg K984574 - INFINITY GLUCOSE REAGENT K984574 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Feb 1999. https://www.510kdatabase.net/k983400/ 1999-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k983400-auto-suture-site-marker-clip-fda-510k.jpg K983400 - AUTO SUTURE SITE MARKER CLIP K983400 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Feb 1999. https://www.510kdatabase.net/k983704/ 1999-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k983704-modification-to-abuscreen-online-for-fda-510k.jpg K983704 - MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE K983704 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Feb 1999. https://www.510kdatabase.net/k990088/ 1999-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k990088-synthofil-nonabsorbable-pet-surgical-fda-510k.jpg K990088 - SYNTHOFIL NONABSORBABLE PET SURGICAL SUTURE K990088 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Feb 1999. https://www.510kdatabase.net/k990104/ 1999-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k990104-medtronic-model-7495-extension-kit-fda-510k.jpg K990104 - MEDTRONIC MODEL 7495 EXTENSION KIT K990104 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Feb 1999. https://www.510kdatabase.net/k984326/ 1999-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k984326-elecys-ige-assay-fda-510k.jpg K984326 - ELECYS IGE ASSAY K984326 is a FDA 510(k) cleared immunology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Feb 1999. https://www.510kdatabase.net/k984336/ 1999-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k984336-quanta-lite-gbm-elisa-fda-510k.jpg K984336 - QUANTA LITE GBM ELISA K984336 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Feb 1999. https://www.510kdatabase.net/k984588/ 1999-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k984588-phased-array-flexible-cardiac-coil-fda-510k.jpg K984588 - PHASED ARRAY FLEXIBLE CARDIAC COIL K984588 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Feb 1999. https://www.510kdatabase.net/k983047/ 1999-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k983047-accu-chek-hq-system-fda-510k.jpg K983047 - ACCU-CHEK HQ SYSTEM K983047 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Feb 1999. https://www.510kdatabase.net/k984301/ 1999-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k984301-abbott-architect-folate-fda-510k.jpg K984301 - ABBOTT ARCHITECT FOLATE K984301 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Feb 1999. https://www.510kdatabase.net/k983005/ 1999-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k983005-perfusor-compact-fda-510k.jpg K983005 - PERFUSOR COMPACT K983005 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Feb 1999. https://www.510kdatabase.net/k990197/ 1999-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k990197-modulus-compatible-stability-mcs-ha-fda-510k.jpg K990197 - MODULUS COMPATIBLE STABILITY (MCS)-HA TOTAL HIP SYSTEM K990197 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Feb 1999. https://www.510kdatabase.net/k984108/ 1999-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k984108-abbott-architect-b12-fda-510k.jpg K984108 - ABBOTT ARCHITECT B12 K984108 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Feb 1999. https://www.510kdatabase.net/k984209/ 1999-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k984209-stainless-steel-taper-foreman-nail-fda-510k.jpg K984209 - STAINLESS STEEL TAPER FOREMAN NAIL CANNULATED SCREW, STAINLESS STEEL CANNULATED SCREW, SHORT THREAD, STAINLESS STEEL PED K984209 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Feb 1999. https://www.510kdatabase.net/k990030/ 1999-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k990030-advanced-revision-product-line-extension-fda-510k.jpg K990030 - ADVANCED REVISION PRODUCT LINE EXTENSION K990030 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Feb 1999. https://www.510kdatabase.net/k984419/ 1999-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k984419-elecsys-ige-calcheck-fda-510k.jpg K984419 - ELECSYS IGE CALCHECK K984419 is a FDA 510(k) cleared immunology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Feb 1999. https://www.510kdatabase.net/k984437/ 1999-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k984437-quantex-aso-crp-rp-control-ii-fda-510k.jpg K984437 - QUANTEX ASO-CRP-RP CONTROL II K984437 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Feb 1999. https://www.510kdatabase.net/k984594/ 1999-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k984594-lyphochek-maternal-serum-control-model-fda-510k.jpg K984594 - LYPHOCHEK MATERNAL SERUM CONTROL, MODEL 220 K984594 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Feb 1999. https://www.510kdatabase.net/k984604/ 1999-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k984604-architect-estradiol-masterchek-model-fda-510k.jpg K984604 - ARCHITECT ESTRADIOL MASTERCHEK, MODEL # 6C22-05 K984604 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Feb 1999. https://www.510kdatabase.net/k984625/ 1999-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k984625-architect-folate-masterchek-model-6c12-fda-510k.jpg K984625 - ARCHITECT FOLATE MASTERCHEK, MODEL # 6C12-05 K984625 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Feb 1999. https://www.510kdatabase.net/k983901/ 1999-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k983901-ksea-hf-snare-fda-510k.jpg K983901 - KSEA HF-SNARE K983901 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Feb 1999. https://www.510kdatabase.net/k984124/ 1999-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k984124-aesculap-xenon-light-source-fda-510k.jpg K984124 - AESCULAP XENON LIGHT SOURCE K984124 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Feb 1999. https://www.510kdatabase.net/k990158/ 1999-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k990158-osteonics-combination-screw-ringblocker-fda-510k.jpg K990158 - OSTEONICS COMBINATION SCREW RING/BLOCKER K990158 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Feb 1999. https://www.510kdatabase.net/k983289/ 1999-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k983289-apolipoprotein-a1-fda-510k.jpg K983289 - APOLIPOPROTEIN A1 K983289 is a FDA 510(k) cleared immunology medical device. Manufacturer: Abbott Laboratories. Cleared Jan 1999. https://www.510kdatabase.net/k983966/ 1999-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k983966-nupro-prophylaxis-paste-with-flouride-fda-510k.jpg K983966 - NUPRO PROPHYLAXIS PASTE WITH FLOURIDE AND TRICLOSAN K983966 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jan 1999. https://www.510kdatabase.net/k984152/ 1999-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k984152-synchron-systems-opiates-2000-ng-op2-fda-510k.jpg K984152 - SYNCHRON SYSTEMS OPIATES 2000 NG (OP2) REAGENT K984152 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jan 1999. https://www.510kdatabase.net/k984369/ 1999-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k984369-dci-endoscope-fda-510k.jpg K984369 - DCI ENDOSCOPE K984369 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jan 1999. https://www.510kdatabase.net/k984402/ 1999-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k984402-synchron-systems-ammonia-amm-reagent-fda-510k.jpg K984402 - SYNCHRON SYSTEMS AMMONIA (AMM) REAGENT K984402 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jan 1999. https://www.510kdatabase.net/k984477/ 1999-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k984477-lyphochek-whole-blood-metals-control-fda-510k.jpg K984477 - LYPHOCHEK WHOLE BLOOD METALS CONTROL LEVELS 1,2,3, MODELS 527, 528, 529 K984477 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Jan 1999. https://www.510kdatabase.net/k984626/ 1999-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k984626-architect-b12-masterchek-model-6c09-o5-fda-510k.jpg K984626 - ARCHITECT B12 MASTERCHEK, MODEL # 6C09-O5 K984626 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Jan 1999. https://www.510kdatabase.net/k973227/ 1999-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k973227-askina-hydrocolloidthin-fda-510k.jpg K973227 - ASKINA HYDROCOLLOID/THIN K973227 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Jan 1999. https://www.510kdatabase.net/k983774/ 1999-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k983774-ualb-fda-510k.jpg K983774 - UALB K983774 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jan 1999. https://www.510kdatabase.net/k984132/ 1999-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k984132-immulite-c-reactive-protein-models-fda-510k.jpg K984132 - IMMULITE C-REACTIVE PROTEIN, MODELS LKC1, LKC5 K984132 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jan 1999. https://www.510kdatabase.net/k984137/ 1999-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k984137-quanta-lite-celiac-screen-tissue-fda-510k.jpg K984137 - QUANTA LITE CELIAC SCREEN (TISSUE TRANSGLUTAMINASE/GLIADIN) ELISA K984137 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Jan 1999. https://www.510kdatabase.net/k984158/ 1999-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k984158-pfc-modular-plus-offset-tibial-tray-fda-510k.jpg K984158 - P.F.C. MODULAR PLUS OFFSET TIBIAL TRAY K984158 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jan 1999. https://www.510kdatabase.net/k984320/ 1999-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k984320-bioabsorbable-interference-screws-fda-510k.jpg K984320 - BIOABSORBABLE INTERFERENCE SCREWS K984320 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jan 1999. https://www.510kdatabase.net/k984459/ 1999-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k984459-depuy-profile-femoral-hip-with-porocoat-fda-510k.jpg K984459 - DEPUY PROFILE FEMORAL HIP WITH POROCOAT K984459 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jan 1999. https://www.510kdatabase.net/k990059/ 1999-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k990059-osteonics-spinal-system-expanded-fda-510k.jpg K990059 - OSTEONICS SPINAL SYSTEM-EXPANDED INDICATIONS K990059 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Osteonics Corp.. Cleared Jan 1999. https://www.510kdatabase.net/k990161/ 1999-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k990161-abbott-liquid-csf-control-model-s-1e98-fda-510k.jpg K990161 - ABBOTT LIQUID CSF CONTROL, MODEL #'S 1E98-01, 1E99-01 K990161 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Jan 1999. https://www.510kdatabase.net/k990162/ 1999-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k990162-abbott-liquid-ammonia-control-model-s-fda-510k.jpg K990162 - ABBOTT LIQUID AMMONIA CONTROL, MODEL #'S 1E93-01,1E94-01,1E95-01 K990162 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Jan 1999. https://www.510kdatabase.net/k981359/ 1999-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k981359-gt-leggiero-fda-510k.jpg K981359 - GT LEGGIERO K981359 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Jan 1999. https://www.510kdatabase.net/k982095/ 1999-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k982095-lactosorb-meniscal-repair-device-fda-510k.jpg K982095 - LACTOSORB MENISCAL REPAIR DEVICE K982095 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jan 1999. https://www.510kdatabase.net/k982500/ 1999-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k982500-chait-cecostomy-catheter-fda-510k.jpg K982500 - CHAIT CECOSTOMY CATHETER K982500 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook, Inc.. Cleared Jan 1999. https://www.510kdatabase.net/k983281/ 1999-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k983281-apob-fda-510k.jpg K983281 - APOB K983281 is a FDA 510(k) cleared immunology medical device. Manufacturer: Abbott Laboratories. Cleared Jan 1999. https://www.510kdatabase.net/k984260/ 1999-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k984260-pinnacle-ro-or-redifocus-introducer-ro-fda-510k.jpg K984260 - PINNACLE R/O OR REDIFOCUS INTRODUCER R/O (COMPRISED OF A SHEATH & DILATOR) K984260 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Jan 1999. https://www.510kdatabase.net/k990149/ 1999-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k990149-abbott-liquid-pediatric-chemistry-fda-510k.jpg K990149 - ABBOTT LIQUID PEDIATRIC CHEMISTRY CONTROL, MODEL # 4E37-01, 4E38-01 K990149 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Jan 1999. https://www.510kdatabase.net/k990150/ 1999-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k990150-abbott-liquid-lipids-chemistry-model-s-fda-510k.jpg K990150 - ABBOTT LIQUID LIPIDS CHEMISTRY, MODEL #'S 3E18-01, 3E19-01 K990150 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Jan 1999. https://www.510kdatabase.net/k983905/ 1999-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k983905-kodak-digital-science-3600-distributed-fda-510k.jpg K983905 - KODAK DIGITAL SCIENCE 3600 DISTRIBUTED MEDICAL IMAGER, KODAK DIGITAL SCIENCE 1200 DISTRIBUTED MEDICAL IMAGER, MODEL 3600 K983905 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Jan 1999. https://www.510kdatabase.net/k990017/ 1999-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k990017-abbott-immunoassay-mcc-liquid-control-fda-510k.jpg K990017 - ABBOTT IMMUNOASSAY-MCC (LIQUID) CONTROL, MODEL NUMBER 6E20-10 K990017 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Jan 1999. https://www.510kdatabase.net/k984181/ 1999-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k984181-the-aptus-automated-application-of-the-fda-510k.jpg K984181 - THE APTUS (AUTOMATED) APPLICATION OF THE VZV IGG ELISA TEST SYSTEM K984181 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Jan 1999. https://www.510kdatabase.net/k984232/ 1999-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k984232-modification-of-emit-dau-opiates-assay-fda-510k.jpg K984232 - MODIFICATION OF EMIT D.A.U. OPIATES ASSAY K984232 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jan 1999. https://www.510kdatabase.net/k984317/ 1999-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k984317-the-aptus-automated-application-of-the-fda-510k.jpg K984317 - THE APTUS (AUTOMATED) APPLICATION OF THE TOXOPLASMA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)F K984317 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Jan 1999. https://www.510kdatabase.net/k983787/ 1999-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k983787-synthes-proximal-tibia-plating-system-fda-510k.jpg K983787 - SYNTHES PROXIMAL TIBIA PLATING SYSTEM K983787 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jan 1999. https://www.510kdatabase.net/k984377/ 1999-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k984377-synthes-spine-cervifix-system-fda-510k.jpg K984377 - SYNTHES SPINE CERVIFIX SYSTEM K984377 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jan 1999. https://www.510kdatabase.net/k982332/ 1999-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k982332-steris-ten-sixteen-steam-sterilizer-fda-510k.jpg K982332 - STERIS TEN SIXTEEN STEAM STERILIZER K982332 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Jan 1999. https://www.510kdatabase.net/k983217/ 1999-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k983217-rowe-dual-check-valve-fda-510k.jpg K983217 - ROWE DUAL-CHECK VALVE K983217 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cook, Inc.. Cleared Jan 1999. https://www.510kdatabase.net/k984425/ 1999-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k984425-modification-of-preciset-serum-fda-510k.jpg K984425 - MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR K984425 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jan 1999. https://www.510kdatabase.net/k984028/ 1999-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k984028-the-new-bio-moore-endo-heads-fda-510k.jpg K984028 - THE NEW BIO-MOORE ENDO HEADS K984028 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jan 1999. https://www.510kdatabase.net/k984170/ 1999-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k984170-the-aptus-automated-application-of-the-fda-510k.jpg K984170 - THE APTUS (AUTOMATED) APPLICATION OF THE TOXOPLASMA IGM ELISA TEST SYSTEM K984170 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Jan 1999. https://www.510kdatabase.net/k982805/ 1999-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k982805-introcan-safety-iv-catheter-fda-510k.jpg K982805 - INTROCAN SAFETY IV CATHETER K982805 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Jan 1999. https://www.510kdatabase.net/k984541/ 1999-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k984541-global-fx-humeral-stem-global-fda-510k.jpg K984541 - GLOBAL FX HUMERAL STEM, GLOBAL ADVANTAGE HUMERAL HEAD K984541 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jan 1999. https://www.510kdatabase.net/k984067/ 1999-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k984067-stratus-r-cs-stat-fluorometric-fda-510k.jpg K984067 - STRATUS (R) CS STAT FLUOROMETRIC ANALYZER, STRATUS (R) CS CKMB TEST PAK K984067 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Jan 1999. https://www.510kdatabase.net/k984387/ 1999-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k984387-r-30-aesthetic-restorative-fda-510k.jpg K984387 - R-30 AESTHETIC RESTORATIVE K984387 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jan 1999. https://www.510kdatabase.net/k982159/ 1999-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k982159-abbott-plum-a-infusion-pump-fda-510k.jpg K982159 - ABBOTT PLUM A+ INFUSION PUMP K982159 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Jan 1999. https://www.510kdatabase.net/k984167/ 1999-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k984167-sage-7-fda-510k.jpg K984167 - SAGE 7 K984167 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Jan 1999. https://www.510kdatabase.net/k983849/ 1999-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k983849-dimension-automated-high-density-fda-510k.jpg K983849 - DIMENSION AUTOMATED HIGH DENSITY LIPOPROTEIN CHOLESTEROL (ADHL) FLEX REAGENT CARTRIDGE K983849 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Jan 1999. https://www.510kdatabase.net/k984123/ 1999-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k984123-the-aptus-automated-application-of-the-fda-510k.jpg K984123 - THE APTUS (AUTOMATED) APPLICATION OF THE LEGIONELLA IGG/A/M (ELISA) TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (E K984123 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Jan 1999. https://www.510kdatabase.net/k984126/ 1999-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k984126-the-aptus-automated-application-of-the-fda-510k.jpg K984126 - THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR K984126 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Jan 1999. https://www.510kdatabase.net/k984133/ 1999-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k984133-the-aptus-automated-application-of-the-fda-510k.jpg K984133 - THE APTUS (AUTOMATED) APPLICATION OF THE EBNA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR TH K984133 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Jan 1999. https://www.510kdatabase.net/k984139/ 1999-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k984139-the-aptus-automated-application-of-the-fda-510k.jpg K984139 - THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE K984139 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Jan 1999. https://www.510kdatabase.net/k984153/ 1999-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k984153-the-aptus-automated-application-of-the-fda-510k.jpg K984153 - THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM. K984153 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Jan 1999. https://www.510kdatabase.net/k984516/ 1999-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k984516-the-aptus-automated-application-of-the-fda-510k.jpg K984516 - THE APTUS (AUTOMATED) APPLICATION OF THE MPO ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DET K984516 is a FDA 510(k) cleared immunology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Jan 1999. https://www.510kdatabase.net/k983569/ 1999-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k983569-ksea-monopolar-vaporization-electrodes-fda-510k.jpg K983569 - KSEA MONOPOLAR VAPORIZATION ELECTRODES K983569 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jan 1999. https://www.510kdatabase.net/k984435/ 1999-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k984435-medtronic-khonsari-annuloplasty-band-fda-510k.jpg K984435 - MEDTRONIC KHONSARI ANNULOPLASTY BAND, MODEL H609M K984435 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jan 1999. https://www.510kdatabase.net/k984438/ 1999-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k984438-modified-auto-suturevcs-fda-510k.jpg K984438 - MODIFIED AUTO SUTURE*VCS** ANASTOMOTIC**CLIP CARTRIDGE K984438 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Jan 1999. https://www.510kdatabase.net/k981376/ 1999-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k981376-hewlett-packard-m1205a-viridia-24-ct-fda-510k.jpg K981376 - HEWLETT-PACKARD M1205A VIRIDIA 24 CT K981376 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Jan 1999. https://www.510kdatabase.net/k983747/ 1998-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k983747-synchron-systems-dat-low-and-high-fda-510k.jpg K983747 - SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS II K983747 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Dec 1998. https://www.510kdatabase.net/k984342/ 1998-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k984342-anterior-cervical-plating-system-fda-510k.jpg K984342 - ANTERIOR CERVICAL PLATING SYSTEM K984342 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Dec 1998. https://www.510kdatabase.net/k984378/ 1998-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k984378-depuy-acromed-moss-spinal-system-fda-510k.jpg K984378 - DEPUY ACROMED MOSS SPINAL SYSTEM K984378 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Dec 1998. https://www.510kdatabase.net/k984401/ 1998-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k984401-neuromag-vectorview-fda-510k.jpg K984401 - NEUROMAG VECTORVIEW K984401 is a FDA 510(k) cleared neurology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Dec 1998. https://www.510kdatabase.net/k983514/ 1998-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k983514-positron-option-model-nsco-050a-fda-510k.jpg K983514 - POSITRON OPTION, MODEL NSCO-050A K983514 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Dec 1998. https://www.510kdatabase.net/k983516/ 1998-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k983516-transmission-kit-trans-ct-model-nstr-fda-510k.jpg K983516 - TRANSMISSION KIT, TRANS-CT, MODEL NSTR-050A K983516 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Dec 1998. https://www.510kdatabase.net/k983528/ 1998-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k983528-micro-dynamic-mesh-fda-510k.jpg K983528 - MICRO DYNAMIC MESH K983528 is a FDA 510(k) cleared dental medical device. Manufacturer: Howmedica Corp.. Cleared Dec 1998. https://www.510kdatabase.net/k984014/ 1998-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k984014-synchron-systems-enzyme-validator-set-fda-510k.jpg K984014 - SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2 K984014 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Dec 1998. https://www.510kdatabase.net/k984500/ 1998-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k984500-cordis-brite-tip-catheter-sheath-fda-510k.jpg K984500 - CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM K984500 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Dec 1998. https://www.510kdatabase.net/k983404/ 1998-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k983404-type-3-femoral-components-fda-510k.jpg K983404 - TYPE 3 FEMORAL COMPONENTS K983404 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Dec 1998. https://www.510kdatabase.net/k983899/ 1998-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k983899-thoracolumbar-spinal-rod-system-empower-fda-510k.jpg K983899 - THORACOLUMBAR SPINAL ROD SYSTEM (EMPOWER) K983899 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Dec 1998. https://www.510kdatabase.net/k983904/ 1998-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k983904-rogozinski-spinal-rod-system-fda-510k.jpg K983904 - ROGOZINSKI SPINAL ROD SYSTEM K983904 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Dec 1998. https://www.510kdatabase.net/k984173/ 1998-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k984173-the-aptus-automated-application-of-the-fda-510k.jpg K984173 - THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGA ELISA TEST SYSTEM K984173 is a FDA 510(k) cleared immunology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Dec 1998. https://www.510kdatabase.net/k984319/ 1998-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k984319-architect-free-t3-mastercheck-model-fda-510k.jpg K984319 - ARCHITECT FREE T3 MASTERCHECK, MODEL NUMBER 6C48-05 K984319 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Dec 1998. https://www.510kdatabase.net/k984327/ 1998-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k984327-architect-total-t3-mastercheck-model-fda-510k.jpg K984327 - ARCHITECT TOTAL T3 MASTERCHECK, MODEL NUMBER 6C51-05 K984327 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Dec 1998. https://www.510kdatabase.net/k984462/ 1998-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k984462-liquichek-ena-control-eia-screen-model-fda-510k.jpg K984462 - LIQUICHEK ENA CONTROL, EIA SCREEN, MODEL NO. 206 K984462 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Dec 1998. https://www.510kdatabase.net/k984464/ 1998-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k984464-liquichek-anti-jo-1-control-eia-model-fda-510k.jpg K984464 - LIQUICHEK ANTI-JO 1 CONTROL, EIA, MODEL NO. 211 K984464 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Dec 1998. https://www.510kdatabase.net/k984470/ 1998-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k984470-liquichek-anti-ss-a-control-eia-model-fda-510k.jpg K984470 - LIQUICHEK ANTI-SS-A CONTROL, EIA, MODEL 209 K984470 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Dec 1998. https://www.510kdatabase.net/k984473/ 1998-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k984473-liquichek-ana-control-eia-screen-model-fda-510k.jpg K984473 - LIQUICHEK ANA CONTROL, EIA SCREEN, MODEL 205 K984473 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Dec 1998. https://www.510kdatabase.net/k984475/ 1998-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k984475-liquichek-anti-scl-70-control-eia-fda-510k.jpg K984475 - LIQUICHEK ANTI-SCL-70 CONTROL, EIA, MODEL 212 K984475 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Dec 1998. https://www.510kdatabase.net/k984476/ 1998-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k984476-liquichek-anti-rnp-control-eia-model-207-fda-510k.jpg K984476 - LIQUICHEK ANTI-RNP CONTROL, EIA, MODEL 207 K984476 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Dec 1998. https://www.510kdatabase.net/k984478/ 1998-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k984478-liquichek-anti-ss-b-control-eia-model-fda-510k.jpg K984478 - LIQUICHEK ANTI-SS-B CONTROL, EIA, MODEL 210 K984478 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Dec 1998. https://www.510kdatabase.net/k984479/ 1998-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k984479-liquichek-anti-sm-control-eia-model-208-fda-510k.jpg K984479 - LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208 K984479 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Dec 1998. https://www.510kdatabase.net/k983342/ 1998-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k983342-mr-guided-procedures-mrgp-basic-package-fda-510k.jpg K983342 - MR GUIDED PROCEDURES (MRGP) BASIC PACKAGE K983342 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Dec 1998. https://www.510kdatabase.net/k983485/ 1998-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k983485-synthes-13-mm-self-drilling-screw-fda-510k.jpg K983485 - SYNTHES 1.3 MM SELF-DRILLING SCREW K983485 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Dec 1998. https://www.510kdatabase.net/k983640/ 1998-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k983640-synchron-systems-lipid-calibrator-fda-510k.jpg K983640 - SYNCHRON SYSTEMS LIPID CALIBRATOR K983640 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Dec 1998. https://www.510kdatabase.net/k980823/ 1998-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k980823-cordis-nitinol-stent-and-delivery-system-fda-510k.jpg K980823 - CORDIS NITINOL STENT AND DELIVERY SYSTEM K980823 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Dec 1998. https://www.510kdatabase.net/k982379/ 1998-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k982379-sundt-slim-line-aneurysm-clip-applier-fda-510k.jpg K982379 - SUNDT SLIM-LINE ANEURYSM CLIP APPLIER K982379 is a FDA 510(k) cleared neurology medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Dec 1998. https://www.510kdatabase.net/k983363/ 1998-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k983363-dci-endoscope-fda-510k.jpg K983363 - DCI ENDOSCOPE K983363 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Dec 1998. https://www.510kdatabase.net/k983365/ 1998-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k983365-aesculap-minop-system-fda-510k.jpg K983365 - AESCULAP MINOP SYSTEM K983365 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Dec 1998. https://www.510kdatabase.net/k983758/ 1998-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k983758-yasargil-titanium-aneurysm-clips-fda-510k.jpg K983758 - YASARGIL TITANIUM ANEURYSM CLIPS K983758 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Dec 1998. https://www.510kdatabase.net/k983766/ 1998-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k983766-synthes-synmesh-fda-510k.jpg K983766 - SYNTHES SYNMESH K983766 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Synthes (Usa). Cleared Dec 1998. https://www.510kdatabase.net/k983906/ 1998-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k983906-depuy-orthotech-spiked-washer-fda-510k.jpg K983906 - DEPUY ORTHOTECH SPIKED WASHER K983906 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Dec 1998. https://www.510kdatabase.net/k984302/ 1998-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k984302-osteonics-spinal-system-cylindrical-fda-510k.jpg K984302 - OSTEONICS SPINAL SYSTEM CYLINDRICAL BONE SCREWS K984302 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Dec 1998. https://www.510kdatabase.net/k984396/ 1998-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k984396-liquichek-anti-dsdna-control-model-213-fda-510k.jpg K984396 - LIQUICHEK ANTI-DSDNA CONTROL, MODEL 213 K984396 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Dec 1998. https://www.510kdatabase.net/k984397/ 1998-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k984397-liquichek-ana-control-centromere-fda-510k.jpg K984397 - LIQUICHEK ANA CONTROL, CENTROMERE PATTERN, MODEL 203 K984397 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Dec 1998. https://www.510kdatabase.net/k984398/ 1998-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k984398-liquichek-ana-control-homogeneous-fda-510k.jpg K984398 - LIQUICHEK ANA CONTROL, HOMOGENEOUS PATTERN, MODEL 201 K984398 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Dec 1998. https://www.510kdatabase.net/k984399/ 1998-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k984399-liquichek-ana-control-nucleolar-fda-510k.jpg K984399 - LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, MODEL 204 K984399 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Dec 1998. https://www.510kdatabase.net/k984400/ 1998-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k984400-liquichek-ana-control-speckled-pattern-fda-510k.jpg K984400 - LIQUICHEK ANA CONTROL, SPECKLED PATTERN, MODEL 202 K984400 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Dec 1998. https://www.510kdatabase.net/k982426/ 1998-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k982426-spife-alkaline-hemoglobin-fda-510k.jpg K982426 - SPIFE ALKALINE HEMOGLOBIN K982426 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Dec 1998. https://www.510kdatabase.net/k982981/ 1998-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k982981-new-zimmer-shoulder-system-fda-510k.jpg K982981 - NEW ZIMMER SHOULDER SYSTEM K982981 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Dec 1998. https://www.510kdatabase.net/k983954/ 1998-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k983954-alastat-microplate-mixed-allergen-panels-fda-510k.jpg K983954 - ALASTAT MICROPLATE MIXED ALLERGEN PANELS K983954 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Dec 1998. https://www.510kdatabase.net/k984175/ 1998-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k984175-the-aptus-automated-application-of-the-fda-510k.jpg K984175 - THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGM ELISA TEST SYSTEM K984175 is a FDA 510(k) cleared immunology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Dec 1998. https://www.510kdatabase.net/k984268/ 1998-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k984268-variant-ii-hemoglobin-a1c-program-fda-510k.jpg K984268 - VARIANT II HEMOGLOBIN A1C PROGRAM K984268 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bio-Rad. Cleared Dec 1998. https://www.510kdatabase.net/k984286/ 1998-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k984286-heartstream-electrode-adapter-fda-510k.jpg K984286 - HEARTSTREAM ELECTRODE ADAPTER K984286 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Dec 1998. https://www.510kdatabase.net/k984315/ 1998-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k984315-the-aptus-automated-application-of-the-fda-510k.jpg K984315 - THE APTUS (AUTOMATED) APPLICATION OF THE PR-3 ELISA TEST SYSTEM. AN ANEYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DE K984315 is a FDA 510(k) cleared immunology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Dec 1998. https://www.510kdatabase.net/k984325/ 1998-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k984325-architect-ferritin-mastercheck-model-fda-510k.jpg K984325 - ARCHITECT FERRITIN MASTERCHECK, MODEL NUMBER 6C11-05 K984325 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Dec 1998. https://www.510kdatabase.net/k984347/ 1998-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k984347-the-aptus-automated-application-of-the-fda-510k.jpg K984347 - THE APTUS (AUTOMATED) APPLICATION OF THE ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (F K984347 is a FDA 510(k) cleared immunology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Dec 1998. https://www.510kdatabase.net/k970736/ 1998-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k970736-braun-prefilled-syringe-fda-510k.jpg K970736 - BRAUN PREFILLED SYRINGE K970736 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Dec 1998. https://www.510kdatabase.net/k980925/ 1998-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k980925-duration-ii-tibial-inserts-ethylene-fda-510k.jpg K980925 - DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION K980925 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Dec 1998. https://www.510kdatabase.net/k980926/ 1998-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k980926-duration-ii-acetabular-components-fda-510k.jpg K980926 - DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION K980926 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Dec 1998. https://www.510kdatabase.net/k983293/ 1998-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k983293-auto-suture-laparoscopes-device-fda-510k.jpg K983293 - AUTO SUTURE LAPAROSCOPES DEVICE K983293 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Dec 1998. https://www.510kdatabase.net/k983502/ 1998-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k983502-osteonics-secur-fit-ad-generation-ii-fda-510k.jpg K983502 - OSTEONICS SECUR-FIT AD GENERATION II ACETABULAR COMPONENT SYSTEM K983502 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Dec 1998. https://www.510kdatabase.net/k983530/ 1998-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k983530-synthes-posterior-universal-spinal-fda-510k.jpg K983530 - SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM K983530 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Dec 1998. https://www.510kdatabase.net/k983807/ 1998-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k983807-lyphochek-tumor-marker-control-model-580-fda-510k.jpg K983807 - LYPHOCHEK TUMOR MARKER CONTROL, MODEL #580 K983807 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Dec 1998. https://www.510kdatabase.net/k983967/ 1998-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k983967-pediatric-cannulated-osteotomy-plates-fda-510k.jpg K983967 - PEDIATRIC CANNULATED OSTEOTOMY PLATES K983967 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Dec 1998. https://www.510kdatabase.net/k984353/ 1998-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k984353-osteo-9mm-ic-tibial-nail-fda-510k.jpg K984353 - OSTEO 9MM IC TIBIAL NAIL K984353 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Dec 1998. https://www.510kdatabase.net/k983256/ 1998-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k983256-advantage-windows-aw-fusion-fda-510k.jpg K983256 - ADVANTAGE WINDOWS (AW) FUSION K983256 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Dec 1998. https://www.510kdatabase.net/k983498/ 1998-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k983498-bard-inlay-lubricious-double-pigtail-fda-510k.jpg K983498 - BARD INLAY LUBRICIOUS DOUBLE PIGTAIL URETERAL STENT WITH SUTURE (HEREINAFTER REFERRED TO AS BARD LUBRICIOUS URETERAL STE K983498 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 1998. https://www.510kdatabase.net/k983555/ 1998-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k983555-abuscreen-online-benz-200-calibrators-fda-510k.jpg K983555 - ABUSCREEN ONLINE BENZ 200 CALIBRATORS K983555 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Dec 1998. https://www.510kdatabase.net/k983556/ 1998-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k983556-abuscreen-online-benz-300-calibrators-fda-510k.jpg K983556 - ABUSCREEN ONLINE BENZ 300 CALIBRATORS K983556 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Dec 1998. https://www.510kdatabase.net/k984318/ 1998-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k984318-architect-fsh-mastercheck-model-number-fda-510k.jpg K984318 - ARCHITECT FSH MASTERCHECK, MODEL NUMBER 6C24-05 K984318 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Dec 1998. https://www.510kdatabase.net/k984323/ 1998-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k984323-architect-lh-mastercheck-model-number-fda-510k.jpg K984323 - ARCHITECT LH MASTERCHECK, MODEL NUMBER 6C25-05 K984323 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Dec 1998. https://www.510kdatabase.net/k984324/ 1998-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k984324-architect-prolactin-mastercheck-model-fda-510k.jpg K984324 - ARCHITECT PROLACTIN MASTERCHECK, MODEL NUMBER 6C27-05 K984324 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Dec 1998. https://www.510kdatabase.net/k982694/ 1998-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k982694-medline-medcrest-surgical-gowns-and-fda-510k.jpg K982694 - MEDLINE MEDCREST SURGICAL GOWNS AND SURGICAL DRAPES K982694 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Dec 1998. https://www.510kdatabase.net/k983340/ 1998-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k983340-immage-immunochemistry-system-ferritin-fda-510k.jpg K983340 - IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN (FER)REAGENT, IMMAGE IMMUNOCHEMISTRY SYSTEM FERRITIN CALIBRATOR K983340 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Dec 1998. https://www.510kdatabase.net/k983803/ 1998-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k983803-the-aptus-automated-application-of-the-fda-510k.jpg K983803 - THE APTUS (AUTOMATED) APPLICATION OF THE CMV IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE K983803 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Dec 1998. https://www.510kdatabase.net/k984065/ 1998-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k984065-stratus-r-cs-myoglobin-myo-testpak-fda-510k.jpg K984065 - STRATUS (R) CS MYOGLOBIN (MYO) TESTPAK K984065 is a FDA 510(k) cleared immunology medical device. Manufacturer: Dade Behring, Inc.. Cleared Dec 1998. https://www.510kdatabase.net/k984093/ 1998-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k984093-stratus-r-cs-cardiac-troponin-i-trop-fda-510k.jpg K984093 - STRATUS (R) CS CARDIAC TROPONIN I (TROP) TESTPAK K984093 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Dec 1998. https://www.510kdatabase.net/k984193/ 1998-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k984193-dimensions-rxl-myoglobin-myo-calibrator-fda-510k.jpg K984193 - DIMENSIONS RXL MYOGLOBIN (MYO) CALIBRATOR K984193 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Dec 1998. https://www.510kdatabase.net/k984225/ 1998-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k984225-liquichek-serum-volatiles-control-fda-510k.jpg K984225 - LIQUICHEK SERUM VOLATILES CONTROL, MODELS 383 AND 384 K984225 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Dec 1998. https://www.510kdatabase.net/k984372/ 1998-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k984372-elecsys-calcheck-troponin-t-fda-510k.jpg K984372 - ELECSYS CALCHECK TROPONIN T K984372 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Dec 1998. https://www.510kdatabase.net/k980626/ 1998-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k980626-duration-ii-acetabular-components-gas-fda-510k.jpg K980626 - DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION K980626 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Dec 1998. https://www.510kdatabase.net/k980632/ 1998-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k980632-duration-ii-tibial-inserts-gas-plasma-fda-510k.jpg K980632 - DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION K980632 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Dec 1998. https://www.510kdatabase.net/k982078/ 1998-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k982078-immulite-rubella-quantitative-igg-fda-510k.jpg K982078 - IMMULITE RUBELLA QUANTITATIVE IGG, CATALOG # LKRBQ1 (100 TESTS), LKRBQ5 (500 TESTS) K982078 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Dec 1998. https://www.510kdatabase.net/k982323/ 1998-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k982323-olympus-um-2r3r-ultrasonic-probes-and-fda-510k.jpg K982323 - OLYMPUS UM 2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT, FOR BRONCHIAL USE K982323 is a FDA 510(k) cleared radiology medical device. Manufacturer: Olympus America, Inc.. Cleared Dec 1998. https://www.510kdatabase.net/k983382/ 1998-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k983382-osteonics-ha-generation-ii-acetabular-fda-510k.jpg K983382 - OSTEONICS HA GENERATION II ACETABULAR COMPONENT SYSTEM K983382 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Dec 1998. https://www.510kdatabase.net/k983628/ 1998-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k983628-xenon-light-source-auto-lip-5123-model-fda-510k.jpg K983628 - XENON LIGHT SOURCE AUTO LIP 5123, MODEL 2123.011 K983628 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Dec 1998. https://www.510kdatabase.net/k983697/ 1998-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k983697-modification-to-abuscreen-online-fda-510k.jpg K983697 - MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE K983697 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Dec 1998. https://www.510kdatabase.net/k983699/ 1998-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k983699-modification-to-abuscreen-online-for-fda-510k.jpg K983699 - MODIFICATION TO ABUSCREEN ONLINE FOR AMPHETAMINES K983699 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Dec 1998. https://www.510kdatabase.net/k983700/ 1998-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k983700-modification-to-abuscreen-online-for-fda-510k.jpg K983700 - MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE K983700 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Dec 1998. https://www.510kdatabase.net/k983701/ 1998-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k983701-modification-to-abuscreen-online-for-fda-510k.jpg K983701 - MODIFICATION TO ABUSCREEN ONLINE FOR CANNABINOIDS K983701 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Dec 1998. https://www.510kdatabase.net/k983703/ 1998-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k983703-modification-to-abuscreen-online-for-fda-510k.jpg K983703 - MODIFICATION TO ABUSCREEN ONLINE FOR METHADONE K983703 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Dec 1998. https://www.510kdatabase.net/k984111/ 1998-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k984111-fv-rf-fda-510k.jpg K984111 - FV-RF K984111 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Dec 1998. https://www.510kdatabase.net/k983210/ 1998-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k983210-algisite-m-fda-510k.jpg K983210 - ALGISITE M K983210 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Dec 1998. https://www.510kdatabase.net/k983525/ 1998-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k983525-gore-revox-thyroplasty-implant-fda-510k.jpg K983525 - GORE REVOX THYROPLASTY IMPLANT K983525 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Dec 1998. https://www.510kdatabase.net/k983801/ 1998-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k983801-the-aptus-automated-application-of-the-fda-510k.jpg K983801 - THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO K983801 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Dec 1998. https://www.510kdatabase.net/k984191/ 1998-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k984191-myoglobin-flex-reagent-cartridge-fda-510k.jpg K984191 - MYOGLOBIN FLEX REAGENT CARTRIDGE K984191 is a FDA 510(k) cleared immunology medical device. Manufacturer: Dade Behring, Inc.. Cleared Dec 1998. https://www.510kdatabase.net/k983804/ 1998-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k983804-the-aptus-automated-application-of-the-fda-510k.jpg K983804 - THE APTUS (AUTOMATED) APPLICATION OF THE EBV-EA IGG ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR K983804 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Dec 1998. https://www.510kdatabase.net/k984105/ 1998-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k984105-elecsys-troponin-t-stat-test-fda-510k.jpg K984105 - ELECSYS TROPONIN T STAT TEST K984105 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Dec 1998. https://www.510kdatabase.net/k983263/ 1998-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k983263-immulite-afp-model-lkapi-lkap5-fda-510k.jpg K983263 - IMMULITE AFP, MODEL LKAPI, LKAP5, IMMULITE 2000 AFP, MODEL L2KAP2 K983263 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Dec 1998. https://www.510kdatabase.net/k983508/ 1998-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k983508-osteo-compression-condyle-screw-system-fda-510k.jpg K983508 - OSTEO COMPRESSION CONDYLE SCREW SYSTEM K983508 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Dec 1998. https://www.510kdatabase.net/k983759/ 1998-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k983759-abbott-architect-ferritin-fda-510k.jpg K983759 - ABBOTT ARCHITECT FERRITIN K983759 is a FDA 510(k) cleared immunology medical device. Manufacturer: Abbott Laboratories. Cleared Dec 1998. https://www.510kdatabase.net/k983972/ 1998-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k983972-immulite-troponin-i-model-lkti1-and-fda-510k.jpg K983972 - IMMULITE TROPONIN I, MODEL LKTI1 AND LKT15 K983972 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Dec 1998. https://www.510kdatabase.net/k982812/ 1998-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k982812-g2-total-hip-system-femoral-stem-1113-fda-510k.jpg K982812 - G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER) K982812 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Dec 1998. https://www.510kdatabase.net/k983226/ 1998-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k983226-osteonics-x-cemented-hip-stem-series-fda-510k.jpg K983226 - OSTEONICS X CEMENTED HIP STEM SERIES K983226 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Dec 1998. https://www.510kdatabase.net/k983236/ 1998-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k983236-bipolar-hf-cable-fda-510k.jpg K983236 - BIPOLAR HF CABLE K983236 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Dec 1998. https://www.510kdatabase.net/k983641/ 1998-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k983641-holland-femoral-nail-system-fda-510k.jpg K983641 - HOLLAND FEMORAL NAIL SYSTEM K983641 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Dec 1998. https://www.510kdatabase.net/k983942/ 1998-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k983942-intramedullary-nail-system-locking-fda-510k.jpg K983942 - INTRAMEDULLARY NAIL SYSTEM, LOCKING SCREW, NAIL CAP K983942 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Dec 1998. https://www.510kdatabase.net/k983947/ 1998-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k983947-amerse-2-fda-510k.jpg K983947 - AMERSE 2 K983947 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Dec 1998. https://www.510kdatabase.net/k983165/ 1998-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k983165-osteo-40mm-cannulated-screw-system-fda-510k.jpg K983165 - OSTEO 4.0MM CANNULATED SCREW SYSTEM K983165 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Dec 1998. https://www.510kdatabase.net/k983452/ 1998-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k983452-nelson-resurfacing-head-fda-510k.jpg K983452 - NELSON RESURFACING HEAD K983452 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Dec 1998. https://www.510kdatabase.net/k983583/ 1998-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k983583-depuy-acromed-moss-and-moss-miami-fda-510k.jpg K983583 - DEPUY ACROMED MOSS AND MOSS MIAMI SPINAL SYSTEMS K983583 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Dec 1998. https://www.510kdatabase.net/k984071/ 1998-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k984071-liquichek-homocysteine-control-cat-644-fda-510k.jpg K984071 - LIQUICHEK HOMOCYSTEINE CONTROL, CAT #644 K984071 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Dec 1998. https://www.510kdatabase.net/k983279/ 1998-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k983279-endocam-camera-systems-5502-with-fda-510k.jpg K983279 - ENDOCAM CAMERA SYSTEMS 5502 WITH ELECTRONIC CCD ENDOSCOPE K983279 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Dec 1998. https://www.510kdatabase.net/k983491/ 1998-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k983491-depuy-duraloc-acetabular-cup-system-fda-510k.jpg K983491 - DEPUY DURALOC ACETABULAR CUP SYSTEM-ENDURON LINER K983491 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Dec 1998. https://www.510kdatabase.net/k983710/ 1998-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k983710-150mm-cocr-bimetric-headneck-fda-510k.jpg K983710 - 150MM COCR BIMETRIC HEAD/NECK REPLACEMENT HIP STEM- COLOR BUFF FINISH K983710 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Dec 1998. https://www.510kdatabase.net/k983870/ 1998-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k983870-osteonics-restoration-ha-hip-stems-fda-510k.jpg K983870 - OSTEONICS RESTORATION HA HIP STEMS K983870 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Dec 1998. https://www.510kdatabase.net/k983072/ 1998-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k983072-ambulatory-eegsleep-recorder-and-fda-510k.jpg K983072 - AMBULATORY EEG/SLEEP RECORDER AND ACCESSORIES, MODEL # SSR3201 K983072 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Dec 1998. https://www.510kdatabase.net/k983424/ 1998-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k983424-abbott-archeitect-total-b-hcg-fda-510k.jpg K983424 - ABBOTT ARCHEITECT TOTAL B-HCG K983424 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Dec 1998. https://www.510kdatabase.net/k983503/ 1998-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k983503-roche-diagnostics-boehringer-mannheim-fda-510k.jpg K983503 - ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT CATALOG NUMBER 1730347 K983503 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Dec 1998. https://www.510kdatabase.net/k984034/ 1998-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k984034-the-aptus-automated-application-of-the-fda-510k.jpg K984034 - THE APTUS (AUTOMATED) APPLICATION OF THE ANCA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR K984034 is a FDA 510(k) cleared immunology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Nov 1998. https://www.510kdatabase.net/k981365/ 1998-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k981365-mahurkar-135-fr-cuffed-catheter-with-fda-510k.jpg K981365 - MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONS K981365 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Sherwood Medical Co.. Cleared Nov 1998. https://www.510kdatabase.net/k982322/ 1998-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k982322-synthes-spine-occipital-cervical-fda-510k.jpg K982322 - SYNTHES SPINE OCCIPITAL-CERVICAL PLATE/ROD AND HOOK SYSTEM K982322 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Nov 1998. https://www.510kdatabase.net/k983136/ 1998-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k983136-depuy-luster-stem-fda-510k.jpg K983136 - DEPUY LUSTER STEM K983136 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Nov 1998. https://www.510kdatabase.net/k983384/ 1998-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k983384-dci-endoscope-fda-510k.jpg K983384 - DCI ENDOSCOPE K983384 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Nov 1998. https://www.510kdatabase.net/k983419/ 1998-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k983419-hoffmann-ii-miami-post-fda-510k.jpg K983419 - HOFFMANN II MIAMI POST K983419 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Nov 1998. https://www.510kdatabase.net/k983440/ 1998-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k983440-abbott-architect-total-t4-fda-510k.jpg K983440 - ABBOTT ARCHITECT TOTAL T4 K983440 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1998. https://www.510kdatabase.net/k983469/ 1998-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k983469-preciset-serum-proteins-calibrator-fda-510k.jpg K983469 - PRECISET SERUM PROTEINS CALIBRATOR K983469 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Nov 1998. https://www.510kdatabase.net/k983895/ 1998-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k983895-immage-immunochemistry-system-beta-2-fda-510k.jpg K983895 - IMMAGE IMMUNOCHEMISTRY SYSTEM BETA-2 MICROGLOBULIN REAGENT K983895 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Nov 1998. https://www.510kdatabase.net/k983970/ 1998-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k983970-immulite-myoglobin-model-lkmy1-and-lkmy5-fda-510k.jpg K983970 - IMMULITE MYOGLOBIN, MODEL LKMY1 AND LKMY5 K983970 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Nov 1998. https://www.510kdatabase.net/k984070/ 1998-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k984070-architect-free-t4-mastercheck-list-no-fda-510k.jpg K984070 - ARCHITECT FREE T4 MASTERCHECK, LIST NO. 6C50-05 K984070 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Nov 1998. https://www.510kdatabase.net/k984073/ 1998-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k984073-architect-total-p-hcg-mastercheck-list-fda-510k.jpg K984073 - ARCHITECT TOTAL P-HCG MASTERCHECK, LIST NO. 6C21-05 K984073 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Nov 1998. https://www.510kdatabase.net/k982976/ 1998-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k982976-ultrasound-workstation-uiws-300a-fda-510k.jpg K982976 - ULTRASOUND WORKSTATION, UIWS-300A K982976 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Nov 1998. https://www.510kdatabase.net/k984072/ 1998-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k984072-architect-tsh-mastercheck-list-no-6c52-fda-510k.jpg K984072 - ARCHITECT TSH MASTERCHECK, LIST NO, 6C52-05 K984072 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Nov 1998. https://www.510kdatabase.net/k982965/ 1998-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k982965-endocam-camera-systems-55025507-with-fda-510k.jpg K982965 - ENDOCAM CAMERA SYSTEMS 5502/5507 WITH CR CAMERA HEADS AND ACCESSORIES K982965 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Nov 1998. https://www.510kdatabase.net/k983035/ 1998-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k983035-custom-flanged-acetabular-component-fda-510k.jpg K983035 - CUSTOM FLANGED ACETABULAR COMPONENT K983035 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Nov 1998. https://www.510kdatabase.net/k982958/ 1998-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k982958-zeta-multizone-locking-nail-system-fda-510k.jpg K982958 - ZETA MULTIZONE LOCKING NAIL SYSTEM K982958 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Nov 1998. https://www.510kdatabase.net/k983417/ 1998-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k983417-abbott-architect-free-t4-fda-510k.jpg K983417 - ABBOTT ARCHITECT FREE T4 K983417 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1998. https://www.510kdatabase.net/k983434/ 1998-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k983434-abbott-architect-total-t3-fda-510k.jpg K983434 - ABBOTT ARCHITECT TOTAL T3 K983434 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1998. https://www.510kdatabase.net/k983439/ 1998-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k983439-abbott-architect-free-t3-fda-510k.jpg K983439 - ABBOTT ARCHITECT FREE T3 K983439 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1998. https://www.510kdatabase.net/k983442/ 1998-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k983442-abbott-architect-tsh-fda-510k.jpg K983442 - ABBOTT ARCHITECT TSH K983442 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1998. https://www.510kdatabase.net/k983838/ 1998-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k983838-abbott-lifecare-standard-tubing-fda-510k.jpg K983838 - ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP K983838 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1998. https://www.510kdatabase.net/k984074/ 1998-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k984074-architect-total-t4-mastercheck-list-no-fda-510k.jpg K984074 - ARCHITECT TOTAL T4 MASTERCHECK, LIST NO. 6C49-05 K984074 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Nov 1998. https://www.510kdatabase.net/k982010/ 1998-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k982010-facts-fda-510k.jpg K982010 - FACTS K982010 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Nov 1998. https://www.510kdatabase.net/k982362/ 1998-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k982362-abbott-testpack-plus-h-pylori-fda-510k.jpg K982362 - ABBOTT TESTPACK PLUS H. PYLORI K982362 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1998. https://www.510kdatabase.net/k983174/ 1998-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k983174-ontrak-teststik-for-barbiturates-fda-510k.jpg K983174 - ONTRAK TESTSTIK FOR BARBITURATES, ONTRAK TESTSTIK FOR BENZODIAZEPINES K983174 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Nov 1998. https://www.510kdatabase.net/k983212/ 1998-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k983212-abbott-architect-testosterone-fda-510k.jpg K983212 - ABBOTT ARCHITECT TESTOSTERONE K983212 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1998. https://www.510kdatabase.net/k983376/ 1998-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k983376-the-aptus-automated-applicaton-of-the-fda-510k.jpg K983376 - THE APTUS (AUTOMATED) APPLICATON OF THE ENA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR S K983376 is a FDA 510(k) cleared immunology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Nov 1998. https://www.510kdatabase.net/k983378/ 1998-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k983378-the-aptus-automated-application-of-the-fda-510k.jpg K983378 - THE APTUS (AUTOMATED) APPLICATION OF THE ANA SCREEN ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR. K983378 is a FDA 510(k) cleared immunology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Nov 1998. https://www.510kdatabase.net/k983388/ 1998-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k983388-ontrak-testcup-er-fda-510k.jpg K983388 - ONTRAK TESTCUP-ER K983388 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Nov 1998. https://www.510kdatabase.net/k983418/ 1998-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k983418-the-aptusautomatedapplication-of-the-fda-510k.jpg K983418 - THE APTUS(AUTOMATED)APPLICATION OF THE RHEUMATOID FACTOR IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY(EL K983418 is a FDA 510(k) cleared immunology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Nov 1998. https://www.510kdatabase.net/k983420/ 1998-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k983420-the-aptusautomatedapplication-of-the-fda-510k.jpg K983420 - THE APTUS(AUTOMATED)APPLICATION OF THE SM ELISA TEST SYSTEM.AN ENZYME LINK IMMUNOSORBENT ASSAY(ELISA)FOR THE DETECTIOO K983420 is a FDA 510(k) cleared immunology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Nov 1998. https://www.510kdatabase.net/k983422/ 1998-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k983422-the-aptus-automated-applications-of-fda-510k.jpg K983422 - THE APTUS (AUTOMATED) APPLICATIONS OF THE DS DNA ELISA TEST SYSTEM LINKED IMMUNOSORBENT ASSAY(ELISA)FOR THE DET K983422 is a FDA 510(k) cleared immunology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Nov 1998. https://www.510kdatabase.net/k983423/ 1998-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k983423-the-aptus-automated-application-of-the-fda-510k.jpg K983423 - THE APTUS (AUTOMATED) APPLICATION OF THE SCL-70 ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE K983423 is a FDA 510(k) cleared immunology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Nov 1998. https://www.510kdatabase.net/k983425/ 1998-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k983425-the-aptus-automatedapplication-of-the-fda-510k.jpg K983425 - THE APTUS (AUTOMATED)APPLICATION OF THE SSB ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DET K983425 is a FDA 510(k) cleared immunology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Nov 1998. https://www.510kdatabase.net/k983426/ 1998-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k983426-the-aptus-automated-application-of-the-fda-510k.jpg K983426 - THE APTUS (AUTOMATED) APPLICATION OF THE SSA ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE DC K983426 is a FDA 510(k) cleared immunology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Nov 1998. https://www.510kdatabase.net/k983464/ 1998-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k983464-the-aptus-automated-application-of-the-fda-510k.jpg K983464 - THE APTUS (AUTOMATED) APPLICATION OF THE JO-1 ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE K983464 is a FDA 510(k) cleared immunology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Nov 1998. https://www.510kdatabase.net/k983465/ 1998-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k983465-the-aptus-automated-application-of-the-fda-510k.jpg K983465 - THE APTUS (AUTOMATED) APPLICATION OF THE SM/RNP ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FOR THE K983465 is a FDA 510(k) cleared immunology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Nov 1998. https://www.510kdatabase.net/k983850/ 1998-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k983850-dimension-ahdl-calibrator-fda-510k.jpg K983850 - DIMENSION AHDL CALIBRATOR K983850 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Nov 1998. https://www.510kdatabase.net/k983971/ 1998-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k983971-cardiac-marker-control-module-model-cccm-fda-510k.jpg K983971 - CARDIAC MARKER CONTROL MODULE, MODEL CCCM K983971 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Nov 1998. https://www.510kdatabase.net/k982972/ 1998-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k982972-signa-profile-small-head-coil-fda-510k.jpg K982972 - SIGNA PROFILE SMALL HEAD COIL K982972 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Nov 1998. https://www.510kdatabase.net/k983848/ 1998-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k983848-abbott-axsym-myoglobin-fda-510k.jpg K983848 - ABBOTT AXSYM MYOGLOBIN K983848 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1998. https://www.510kdatabase.net/k983980/ 1998-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k983980-siemens-multiview-infinity-telemetry-fda-510k.jpg K983980 - SIEMENS MULTIVIEW INFINITY TELEMETRY SYSTEM ENHANCEMENT, ADDITIONAL ARRHYTHMIA CALLS K983980 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 1998. https://www.510kdatabase.net/k980711/ 1998-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k980711-harrisgalante-porous-hgp-hip-fda-510k.jpg K980711 - HARRIS/GALANTE POROUS (HGP) HIP PROSTHESIS WITH CALCICOAT CERAMIC COATING K980711 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Nov 1998. https://www.510kdatabase.net/k981072/ 1998-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k981072-esprit-ventilator-fda-510k.jpg K981072 - ESPRIT VENTILATOR K981072 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Nov 1998. https://www.510kdatabase.net/k983185/ 1998-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k983185-boehringer-mannheim-tina-quant-ige-test-fda-510k.jpg K983185 - BOEHRINGER MANNHEIM TINA-QUANT IGE TEST K983185 is a FDA 510(k) cleared immunology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Nov 1998. https://www.510kdatabase.net/k983578/ 1998-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k983578-architect-testosterone-mastercheck-fda-510k.jpg K983578 - ARCHITECT TESTOSTERONE MASTERCHECK, MODEL 6C28-05 K983578 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Nov 1998. https://www.510kdatabase.net/k983771/ 1998-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k983771-strategy-coronary-wire-guide-fda-510k.jpg K983771 - STRATEGY CORONARY WIRE GUIDE K983771 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Nov 1998. https://www.510kdatabase.net/k973322/ 1998-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k973322-diapact-crrt-fda-510k.jpg K973322 - DIAPACT CRRT K973322 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Nov 1998. https://www.510kdatabase.net/k982902/ 1998-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k982902-peripheral-nerve-stimulation-fda-510k.jpg K982902 - PERIPHERAL NERVE STIMULATION K982902 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Nov 1998. https://www.510kdatabase.net/k982840/ 1998-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k982840-bsc-sonicath-ultra-intravascular-fda-510k.jpg K982840 - BSC SONICATH ULTRA INTRAVASCULAR ULTRASOUND IMAGING WIRE WITH DETACHABLE ADAPTER & BSC SONICATH ULTRA ULTRASOUND IMAGING K982840 is a FDA 510(k) cleared radiology medical device. Manufacturer: Boston Scientific Corp. Cleared Nov 1998. https://www.510kdatabase.net/k982575/ 1998-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k982575-mesh-surgical-polymeric-fda-510k.jpg K982575 - MESH, SURGICAL, POLYMERIC K982575 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Nov 1998. https://www.510kdatabase.net/k983141/ 1998-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k983141-capitello-condylar-total-elbow-fda-510k.jpg K983141 - CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS K983141 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Nov 1998. https://www.510kdatabase.net/k983632/ 1998-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k983632-siemens-sc-8000-bedside-monitor-fda-510k.jpg K983632 - SIEMENS SC 8000 BEDSIDE MONITOR K983632 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 1998. https://www.510kdatabase.net/k980129/ 1998-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k980129-instruments-for-endoscopic-plastic-fda-510k.jpg K980129 - INSTRUMENTS FOR ENDOSCOPIC PLASTIC SURGERY (EPS) K980129 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Nov 1998. https://www.510kdatabase.net/k980756/ 1998-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k980756-corometrics-transcutaneous-tcpo2co2-fda-510k.jpg K980756 - COROMETRICS TRANSCUTANEOUS TCPO2/CO2 MODULE K980756 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Nov 1998. https://www.510kdatabase.net/k983151/ 1998-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k983151-immage-immunochemistry-system-digoxin-fda-510k.jpg K983151 - IMMAGE IMMUNOCHEMISTRY SYSTEM DIGOXIN (DIG) REAGENT K983151 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Nov 1998. https://www.510kdatabase.net/k982639/ 1998-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k982639-spife-urine-ife-fda-510k.jpg K982639 - SPIFE URINE IFE K982639 is a FDA 510(k) cleared immunology medical device. Manufacturer: Helena Laboratories. Cleared Nov 1998. https://www.510kdatabase.net/k982790/ 1998-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k982790-quanta-lite-h-pylori-igg-elisa-fda-510k.jpg K982790 - QUANTA LITE H. PYLORI IGG ELISA K982790 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Nov 1998. https://www.510kdatabase.net/k982955/ 1998-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k982955-silhouette-vr-fda-510k.jpg K982955 - SILHOUETTE VR K982955 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Nov 1998. https://www.510kdatabase.net/k983083/ 1998-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k983083-quanta-lite-rf-igg-elisa-fda-510k.jpg K983083 - QUANTA LITE RF IGG ELISA K983083 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Nov 1998. https://www.510kdatabase.net/k983084/ 1998-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k983084-quanta-lite-rf-iga-elisa-fda-510k.jpg K983084 - QUANTA LITE RF IGA ELISA K983084 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Nov 1998. https://www.510kdatabase.net/k983132/ 1998-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k983132-igm-fda-510k.jpg K983132 - IGM K983132 is a FDA 510(k) cleared immunology medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1998. https://www.510kdatabase.net/k983167/ 1998-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k983167-trf-fda-510k.jpg K983167 - TRF K983167 is a FDA 510(k) cleared immunology medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1998. https://www.510kdatabase.net/k983209/ 1998-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k983209-synchron-systems-dat-low-and-high-fda-510k.jpg K983209 - SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CALIBRATORS I K983209 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Nov 1998. https://www.510kdatabase.net/k983221/ 1998-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k983221-igg-fda-510k.jpg K983221 - IGG K983221 is a FDA 510(k) cleared immunology medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1998. https://www.510kdatabase.net/k983356/ 1998-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k983356-c4-fda-510k.jpg K983356 - C4 K983356 is a FDA 510(k) cleared immunology medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1998. https://www.510kdatabase.net/k983359/ 1998-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k983359-iga-fda-510k.jpg K983359 - IGA K983359 is a FDA 510(k) cleared immunology medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1998. https://www.510kdatabase.net/k983441/ 1998-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k983441-c3-fda-510k.jpg K983441 - C3 K983441 is a FDA 510(k) cleared immunology medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1998. https://www.510kdatabase.net/k983693/ 1998-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k983693-dimensions-r-rxl-cardiac-troponin-i-fda-510k.jpg K983693 - DIMENSIONS (R) RXL CARDIAC TROPONIN I CALIBRATOR K983693 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Nov 1998. https://www.510kdatabase.net/k983722/ 1998-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k983722-stratus-cs-troponin-i-calibrator-fda-510k.jpg K983722 - STRATUS CS TROPONIN I CALIBRATOR K983722 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Nov 1998. https://www.510kdatabase.net/k981666/ 1998-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k981666-25-mm-lactosorb-screws-fda-510k.jpg K981666 - 2.5 MM LACTOSORB SCREWS K981666 is a FDA 510(k) cleared dental medical device. Manufacturer: Biomet, Inc.. Cleared Nov 1998. https://www.510kdatabase.net/k981886/ 1998-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k981886-vrac-high-dose-rate-hdr-remote-fda-510k.jpg K981886 - VRAC HIGH DOSE RATE (HDR) REMOTE AFTERLOADING CATHETER K981886 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cook, Inc.. Cleared Nov 1998. https://www.510kdatabase.net/k982454/ 1998-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k982454-bipap-vision-ventilatory-support-fda-510k.jpg K982454 - BIPAP VISION VENTILATORY SUPPORT K982454 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Nov 1998. https://www.510kdatabase.net/k983101/ 1998-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k983101-bardex-ic-4-way-foley-catheter-model-fda-510k.jpg K983101 - BARDEX I.C 4-WAY FOLEY CATHETER MODEL 1865SIXX XX = 18,20,22,24 K983101 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 1998. https://www.510kdatabase.net/k983178/ 1998-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k983178-coamatic-heparin-fda-510k.jpg K983178 - COAMATIC HEPARIN K983178 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Nov 1998. https://www.510kdatabase.net/k983294/ 1998-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k983294-all-in-one-container-cats-2b81142b8124-fda-510k.jpg K983294 - ALL-IN-ONE CONTAINER CAT#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102, 2B8152, 2B8112, 2B8117M 2B8122, 2B8132, 2B8142, 2B712 K983294 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Nov 1998. https://www.510kdatabase.net/k980576/ 1998-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k980576-varian-endometrial-applicator-for-fda-510k.jpg K980576 - VARIAN ENDOMETRIAL APPLICATOR FOR VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER K980576 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Nov 1998. https://www.510kdatabase.net/k981508/ 1998-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k981508-vectorvision-spine-module-fda-510k.jpg K981508 - VECTORVISION SPINE MODULE K981508 is a FDA 510(k) cleared neurology medical device. Manufacturer: Brainlab AG. Cleared Oct 1998. https://www.510kdatabase.net/k981528/ 1998-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k981528-sonoline-elegra-diagnostic-ultrasound-fda-510k.jpg K981528 - SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM K981528 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 1998. https://www.510kdatabase.net/k982662/ 1998-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k982662-depuy-profile-round-head-interference-fda-510k.jpg K982662 - DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW, DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW K982662 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Oct 1998. https://www.510kdatabase.net/k982693/ 1998-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k982693-medine-disposable-sterile-zoned-fda-510k.jpg K982693 - MEDINE DISPOSABLE STERILE ZONED IMPERVIOUS SURGICAL GOWNS K982693 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Oct 1998. https://www.510kdatabase.net/k983709/ 1998-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k983709-synchron-systems-dat-low-and-high-fda-510k.jpg K983709 - SYNCHRON SYSTEMS DAT LOW AND HIGH URINE CONTROLS 1 K983709 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Oct 1998. https://www.510kdatabase.net/k982948/ 1998-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k982948-elecsys-psa-model-elecsys-1010-fda-510k.jpg K982948 - ELECSYS PSA, MODEL # ELECSYS 1010 K982948 is a FDA 510(k) cleared immunology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Oct 1998. https://www.510kdatabase.net/k982949/ 1998-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k982949-elecsys-psa-model-2010-fda-510k.jpg K982949 - ELECSYS PSA, MODEL 2010 K982949 is a FDA 510(k) cleared immunology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Oct 1998. https://www.510kdatabase.net/k983014/ 1998-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k983014-summit-acetabular-system-fda-510k.jpg K983014 - SUMMIT ACETABULAR SYSTEM K983014 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Oct 1998. https://www.510kdatabase.net/k983339/ 1998-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k983339-osteo-dynatroc-proximal-femoral-nail-fda-510k.jpg K983339 - OSTEO DYNATROC PROXIMAL FEMORAL NAIL K983339 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Oct 1998. https://www.510kdatabase.net/k983510/ 1998-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k983510-chemstrip-101-urine-analyzer-fda-510k.jpg K983510 - CHEMSTRIP 101 URINE ANALYZER K983510 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Oct 1998. https://www.510kdatabase.net/k983548/ 1998-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k983548-ferritin-calibrator-fda-510k.jpg K983548 - FERRITIN CALIBRATOR K983548 is a FDA 510(k) cleared immunology medical device. Manufacturer: Dade Behring, Inc.. Cleared Oct 1998. https://www.510kdatabase.net/k982892/ 1998-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k982892-3m-tegasorb-thin-hydrocolloid-dressing-fda-510k.jpg K982892 - 3M TEGASORB THIN HYDROCOLLOID DRESSING K982892 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3M Company. Cleared Oct 1998. https://www.510kdatabase.net/k982893/ 1998-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k982893-3m-tegasorb-hydrocolloid-dressing-fda-510k.jpg K982893 - 3M TEGASORB HYDROCOLLOID DRESSING K982893 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3M Company. Cleared Oct 1998. https://www.510kdatabase.net/k983197/ 1998-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k983197-surgical-dynamics-rodding-system-fda-510k.jpg K983197 - SURGICAL DYNAMICS RODDING SYSTEM (PREVIOUSLY KNOWN AS THE AURORA TITANIUM SPINAL ROD SYSTEM) K983197 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Oct 1998. https://www.510kdatabase.net/k981791/ 1998-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k981791-mg-fda-510k.jpg K981791 - MG K981791 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1998. https://www.510kdatabase.net/k982725/ 1998-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k982725-olympus-mh-246r-balloon-sheath-for-fda-510k.jpg K982725 - OLYMPUS MH-246R BALLOON SHEATH, FOR FEMALE REPRODUCTIVE TRACT USE K982725 is a FDA 510(k) cleared radiology medical device. Manufacturer: Olympus America, Inc.. Cleared Oct 1998. https://www.510kdatabase.net/k980590/ 1998-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k980590-varisource-henschke-type-gyn-fda-510k.jpg K980590 - VARISOURCE HENSCHKE TYPE GYN APPLICATOR FOR VARIAN VARISOURCE REMOTE HIGH DOSE RATE AFTERLOADER K980590 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Oct 1998. https://www.510kdatabase.net/k982787/ 1998-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k982787-asteion-ct-scanner-tsx-021a-fda-510k.jpg K982787 - ASTEION CT SCANNER, TSX-021A K982787 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Oct 1998. https://www.510kdatabase.net/k982873/ 1998-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k982873-zeta-multizone-scn-locking-nail-fda-510k.jpg K982873 - ZETA MULTIZONE SCN LOCKING NAIL K982873 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Oct 1998. https://www.510kdatabase.net/k982936/ 1998-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k982936-osteonics-extended-femoral-bearing-head-fda-510k.jpg K982936 - OSTEONICS EXTENDED FEMORAL BEARING HEAD K982936 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Oct 1998. https://www.510kdatabase.net/k982953/ 1998-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k982953-titanium-intramedullary-nails-various-fda-510k.jpg K982953 - TITANIUM INTRAMEDULLARY NAILS-VARIOUS STYLES K982953 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Oct 1998. https://www.510kdatabase.net/k983416/ 1998-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k983416-roche-diagnostics-magnesium-reagent-fda-510k.jpg K983416 - ROCHE DIAGNOSTICS MAGNESIUM REAGENT, CAT# 1551353 K983416 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Oct 1998. https://www.510kdatabase.net/k982888/ 1998-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k982888-vaxcel-impantable-vascular-access-system-fda-510k.jpg K982888 - VAXCEL IMPANTABLE VASCULAR ACCESS SYSTEM K982888 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Boston Scientific Corp. Cleared Oct 1998. https://www.510kdatabase.net/k982545/ 1998-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k982545-bmp-cable-system-fda-510k.jpg K982545 - BMP CABLE SYSTEM K982545 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Oct 1998. https://www.510kdatabase.net/k974774/ 1998-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k974774-envy-guiding-catheter-fda-510k.jpg K974774 - ENVY GUIDING CATHETER K974774 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Oct 1998. https://www.510kdatabase.net/k980724/ 1998-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k980724-tinaquant-b-2-microglobulin-assay-fda-510k.jpg K980724 - TINAQUANT B 2-MICROGLOBULIN ASSAY K980724 is a FDA 510(k) cleared immunology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Oct 1998. https://www.510kdatabase.net/k981660/ 1998-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k981660-bard-8-fr-40cc-7fr-30cc-intra-aortic-fda-510k.jpg K981660 - Bard 8 Fr., 40cc. & 7Fr., 30cc Intra-Aortic Balloon Catheters K981660 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 1998. https://www.510kdatabase.net/k982497/ 1998-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k982497-arthrotek-interference-screw-fda-510k.jpg K982497 - ARTHROTEK INTERFERENCE SCREW K982497 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Oct 1998. https://www.510kdatabase.net/k982508/ 1998-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k982508-flexima-fda-510k.jpg K982508 - FLEXIMA K982508 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Oct 1998. https://www.510kdatabase.net/k982531/ 1998-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k982531-howmedica-leibinger-resorbable-fda-510k.jpg K982531 - HOWMEDICA LEIBINGER RESORBABLE FIXATION SYSTEM K982531 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Oct 1998. https://www.510kdatabase.net/k982209/ 1998-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k982209-accuclot-thrombin-time-reagent-model-fda-510k.jpg K982209 - ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589 K982209 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Oct 1998. https://www.510kdatabase.net/k982220/ 1998-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k982220-model-2872-bipolar-lead-adaptor-kit-fda-510k.jpg K982220 - MODEL 2872 BIPOLAR LEAD ADAPTOR KIT K982220 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Oct 1998. https://www.510kdatabase.net/k982658/ 1998-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k982658-ksea-endoscopes-for-dental-procedures-fda-510k.jpg K982658 - KSEA ENDOSCOPES FOR DENTAL PROCEDURES K982658 is a FDA 510(k) cleared dental medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Oct 1998. https://www.510kdatabase.net/k983391/ 1998-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k983391-immulite-2000-om-ma-model-l2kop2-fda-510k.jpg K983391 - IMMULITE 2000 OM-MA MODEL L2KOP2 K983391 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Oct 1998. https://www.510kdatabase.net/k974713/ 1998-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k974713-bard-hydrophillic-coated-guide-wire-fda-510k.jpg K974713 - BARD HYDROPHILLIC COATED GUIDE WIRE K974713 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 1998. https://www.510kdatabase.net/k982935/ 1998-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k982935-synchron-systems-digoxin-dign-reagent-fda-510k.jpg K982935 - SYNCHRON SYSTEMS DIGOXIN (DIGN) REAGENT, SYNCHRON SYSTEMS DRUG CALIBRATOR K982935 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Oct 1998. https://www.510kdatabase.net/k981709/ 1998-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k981709-coagulation-factor-v-deficient-plasma-fda-510k.jpg K981709 - COAGULATION FACTOR V DEFICIENT PLASMA K981709 is a FDA 510(k) cleared hematology medical device. Manufacturer: Dade Behring, Inc.. Cleared Oct 1998. https://www.510kdatabase.net/k982871/ 1998-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k982871-drug-calibrator-ii-fda-510k.jpg K982871 - DRUG CALIBRATOR II K982871 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Dade Behring, Inc.. Cleared Oct 1998. https://www.510kdatabase.net/k982982/ 1998-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k982982-mini-fixator-for-colles-fractures-fda-510k.jpg K982982 - MINI-FIXATOR FOR COLLES FRACTURES K982982 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Oct 1998. https://www.510kdatabase.net/k983327/ 1998-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k983327-active-ecg-electrodes-magnetom-vision-fda-510k.jpg K983327 - ACTIVE ECG ELECTRODES MAGNETOM VISION SYSTEMS K983327 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 1998. https://www.510kdatabase.net/k983387/ 1998-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k983387-ontrak-testcup-and-teststik-controls-fda-510k.jpg K983387 - ONTRAK TESTCUP AND TESTSTIK CONTROLS K983387 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Oct 1998. https://www.510kdatabase.net/k983492/ 1998-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k983492-boehringer-mannheim-elecsys-fda-510k.jpg K983492 - BOEHRINGER MANNHEIM ELECSYS PRESICONTROL CARDIAC K983492 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Oct 1998. https://www.510kdatabase.net/k982603/ 1998-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k982603-quanta-lite-chromatin-elisa-fda-510k.jpg K982603 - QUANTA LITE CHROMATIN ELISA K982603 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Oct 1998. https://www.510kdatabase.net/k982196/ 1998-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k982196-digital-radiographic-imaging-system-fda-510k.jpg K982196 - DIGITAL RADIOGRAPHIC IMAGING SYSTEM K982196 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Oct 1998. https://www.510kdatabase.net/k982387/ 1998-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k982387-ecam-extra-high-energy-collimator-fda-510k.jpg K982387 - E.CAM EXTRA HIGH ENERGY COLLIMATOR K982387 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 1998. https://www.510kdatabase.net/k982564/ 1998-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k982564-delton-fs-direct-delivery-system-fda-510k.jpg K982564 - DELTON FS DIRECT DELIVERY SYSTEM K982564 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Oct 1998. https://www.510kdatabase.net/k982550/ 1998-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k982550-browser-event-software-model-4500e-fda-510k.jpg K982550 - BROWSER (EVENT SOFTWARE) MODEL # 4500E K982550 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Oct 1998. https://www.510kdatabase.net/k982585/ 1998-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k982585-depuy-amk-total-knee-system-depuy-fda-510k.jpg K982585 - DEPUY AMK TOTAL KNEE SYSTEM DEPUY COORDINATE ULTRA KNEE REVISION SYSTEM K982585 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Oct 1998. https://www.510kdatabase.net/k982918/ 1998-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k982918-depuy-c-stem-system-fda-510k.jpg K982918 - DEPUY C-STEM SYSTEM K982918 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Oct 1998. https://www.510kdatabase.net/k980484/ 1998-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k980484-aesculap-spine-system-evolution-fda-510k.jpg K980484 - AESCULAP SPINE SYSTEM EVOLUTION K980484 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aesculap, Inc.. Cleared Oct 1998. https://www.510kdatabase.net/k982670/ 1998-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k982670-contemporary-acetabular-component-fda-510k.jpg K982670 - CONTEMPORARY ACETABULAR COMPONENT K982670 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Oct 1998. https://www.510kdatabase.net/k982914/ 1998-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k982914-aesculap-spine-system-evolution-fda-510k.jpg K982914 - AESCULAP SPINE SYSTEM EVOLUTION: ADDITIONAL COMPONENTS K982914 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aesculap, Inc.. Cleared Oct 1998. https://www.510kdatabase.net/k981295/ 1998-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k981295-upro-fda-510k.jpg K981295 - UPRO K981295 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1998. https://www.510kdatabase.net/k982848/ 1998-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k982848-cobas-integra-ldl-direct-reagent-fda-510k.jpg K982848 - COBAS INTEGRA LDL DIRECT REAGENT CASSETTE ROCHE CALIBRATOR LDL DIRECT K982848 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Oct 1998. https://www.510kdatabase.net/k983023/ 1998-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k983023-modification-to-cordis-brite-tip-fda-510k.jpg K983023 - MODIFICATION TO CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM K983023 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Oct 1998. https://www.510kdatabase.net/k981711/ 1998-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k981711-sysmex-automated-coagulation-analyzer-fda-510k.jpg K981711 - SYSMEX AUTOMATED COAGULATION ANALYZER CA-500 K981711 is a FDA 510(k) cleared hematology medical device. Manufacturer: Dade Behring, Inc.. Cleared Sep 1998. https://www.510kdatabase.net/k982349/ 1998-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k982349-somatom-plus-4with-volume-zoom-ct-fda-510k.jpg K982349 - SOMATOM PLUS 4WITH VOLUME ZOOM CT SCANNERS K982349 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 1998. https://www.510kdatabase.net/k982623/ 1998-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k982623-aesculap-needlescopic-instrument-system-fda-510k.jpg K982623 - AESCULAP NEEDLESCOPIC INSTRUMENT SYSTEM K982623 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Sep 1998. https://www.510kdatabase.net/k982822/ 1998-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k982822-fenwal-20-micron-pediatric-transfusion-fda-510k.jpg K982822 - FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER SET MODEL 4C72 K982822 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Sep 1998. https://www.510kdatabase.net/k981817/ 1998-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k981817-coamatic-plasmin-inhibitor-fda-510k.jpg K981817 - COAMATIC PLASMIN INHIBITOR K981817 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 1998. https://www.510kdatabase.net/k982382/ 1998-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k982382-cobas-integra-reagent-cassettes-fda-510k.jpg K982382 - COBAS INTEGRA REAGENT CASSETTES K982382 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Sep 1998. https://www.510kdatabase.net/k983131/ 1998-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k983131-ast-fda-510k.jpg K983131 - AST K983131 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1998. https://www.510kdatabase.net/k971924/ 1998-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k971924-blunt-syringe-cannula-fda-510k.jpg K971924 - BLUNT SYRINGE CANNULA K971924 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Sep 1998. https://www.510kdatabase.net/k982300/ 1998-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k982300-transview-transmission-systemmodel-fda-510k.jpg K982300 - TRANSVIEW (TRANSMISSION SYSTEM),MODEL NDTR-701A K982300 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Sep 1998. https://www.510kdatabase.net/k982330/ 1998-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k982330-depuy-orthotech-restore-orthobiologic-fda-510k.jpg K982330 - DEPUY ORTHOTECH RESTORE ORTHOBIOLOGIC SOFT TISSUE IMPLANT K982330 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Depuy, Inc.. Cleared Sep 1998. https://www.510kdatabase.net/k983152/ 1998-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k983152-osteonics-spinal-system-55mm-100mm-fda-510k.jpg K983152 - OSTEONICS SPINAL SYSTEM 5.5MM & 10.0MM BONE SCREWS K983152 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Sep 1998. https://www.510kdatabase.net/k981985/ 1998-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k981985-access-cea-reagents-on-the-access-fda-510k.jpg K981985 - ACCESS CEA REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL 33200, 33205, 33206 & 33209 K981985 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Sep 1998. https://www.510kdatabase.net/k983176/ 1998-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k983176-elecsys-myoglobin-stat-assay-fda-510k.jpg K983176 - ELECSYS MYOGLOBIN STAT ASSAY K983176 is a FDA 510(k) cleared immunology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Sep 1998. https://www.510kdatabase.net/k983134/ 1998-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k983134-nbil-fda-510k.jpg K983134 - NBIL K983134 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1998. https://www.510kdatabase.net/k974685/ 1998-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k974685-osteonics-polyethylene-acetabular-fda-510k.jpg K974685 - OSTEONICS POLYETHYLENE ACETABULAR COMPONENTS K974685 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Sep 1998. https://www.510kdatabase.net/k982319/ 1998-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k982319-caregraph-fda-510k.jpg K982319 - CAREGRAPH K982319 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 1998. https://www.510kdatabase.net/k982553/ 1998-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k982553-osteo-compression-hip-screw-system-fda-510k.jpg K982553 - OSTEO COMPRESSION HIP SCREW SYSTEM K982553 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Sep 1998. https://www.510kdatabase.net/k982571/ 1998-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k982571-ksea-flipptack-fda-510k.jpg K982571 - KSEA FLIPPTACK K982571 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Sep 1998. https://www.510kdatabase.net/k982869/ 1998-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k982869-ascent-system-fda-510k.jpg K982869 - ASCENT SYSTEM K982869 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Sep 1998. https://www.510kdatabase.net/k983166/ 1998-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k983166-elecsys-calcheck-myoglobin-fda-510k.jpg K983166 - ELECSYS CALCHECK MYOGLOBIN K983166 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Sep 1998. https://www.510kdatabase.net/k981682/ 1998-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k981682-upro-fda-510k.jpg K981682 - UPRO K981682 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1998. https://www.510kdatabase.net/k982394/ 1998-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k982394-prime-bond-nt-dual-cure-universal-fda-510k.jpg K982394 - PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM K982394 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Sep 1998. https://www.510kdatabase.net/k981297/ 1998-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k981297-immulite-om-ma-models-lkopz-lkop1-lkop5-fda-510k.jpg K981297 - IMMULITE OM-MA, MODELS LKOPZ, LKOP1, LKOP5 K981297 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Sep 1998. https://www.510kdatabase.net/k973448/ 1998-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k973448-access-toxoplasma-igm-reagents-on-the-fda-510k.jpg K973448 - ACCESS TOXOPLASMA IGM REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 34460, 34465, 34469 K973448 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Sep 1998. https://www.510kdatabase.net/k983133/ 1998-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k983133-tbil-fda-510k.jpg K983133 - TBIL K983133 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1998. https://www.510kdatabase.net/k982318/ 1998-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k982318-spectrum-800-curing-unit-fda-510k.jpg K982318 - SPECTRUM 800 CURING UNIT K982318 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Sep 1998. https://www.510kdatabase.net/k980566/ 1998-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k980566-vaxess-peripherally-inserted-central-fda-510k.jpg K980566 - VAXESS PERIPHERALLY INSERTED CENTRAL CATHETER K980566 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Boston Scientific Corp. Cleared Sep 1998. https://www.510kdatabase.net/k982320/ 1998-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k982320-depuy-motech-moss-miami-spinal-system-fda-510k.jpg K982320 - DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM K982320 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Sep 1998. https://www.510kdatabase.net/k982390/ 1998-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k982390-concise-compression-hip-screw-system-fda-510k.jpg K982390 - CONCISE COMPRESSION HIP SCREW SYSTEM (STERILE) K982390 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Sep 1998. https://www.510kdatabase.net/k982483/ 1998-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k982483-depuy-motech-peak-fixation-system-fda-510k.jpg K982483 - DEPUY MOTECH PEAK FIXATION SYSTEM K982483 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Sep 1998. https://www.510kdatabase.net/k982511/ 1998-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k982511-depuy-motech-moss-miami-spinal-systems-fda-510k.jpg K982511 - DEPUY MOTECH MOSS MIAMI SPINAL SYSTEMS K982511 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Sep 1998. https://www.510kdatabase.net/k982601/ 1998-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k982601-osteo-ic-retrogradeantegrade-femoral-fda-510k.jpg K982601 - OSTEO IC RETROGRADE/ANTEGRADE FEMORAL NAIL K982601 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Sep 1998. https://www.510kdatabase.net/k982602/ 1998-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k982602-retrograde-rod-system-fda-510k.jpg K982602 - RETROGRADE ROD SYSTEM K982602 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Sep 1998. https://www.510kdatabase.net/k981334/ 1998-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k981334-laparo-co2-pneu-and-with-video-fda-510k.jpg K981334 - LAPARO CO2-PNEU (AND WITH VIDEO MONITORING) K981334 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Sep 1998. https://www.510kdatabase.net/k982149/ 1998-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k982149-smith-nephew-dyonics-microlaparoscope-fda-510k.jpg K982149 - SMITH & NEPHEW DYONICS MICROLAPAROSCOPE K982149 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Sep 1998. https://www.510kdatabase.net/k982223/ 1998-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k982223-capiox-sx-hardshell-resevoir-fda-510k.jpg K982223 - CAPIOX SX HARDSHELL RESEVOIR K982223 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Sep 1998. https://www.510kdatabase.net/k980429/ 1998-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k980429-hp-m2600a-viridia-telemetry-system-fda-510k.jpg K980429 - HP M2600A VIRIDIA TELEMETRY SYSTEM (FORMERLY KNOWN AS THE HP 2600A OMNI-CARE TELEMETRY SYSTEM) K980429 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Sep 1998. https://www.510kdatabase.net/k982494/ 1998-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k982494-bwm-spine-system-fda-510k.jpg K982494 - BWM SPINE SYSTEM K982494 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Sep 1998. https://www.510kdatabase.net/k982023/ 1998-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k982023-pelicalss-human-igg-subclass-fda-510k.jpg K982023 - PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT K982023 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Sep 1998. https://www.510kdatabase.net/k982025/ 1998-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k982025-hewlett-packard-m2475b-with-12-lead-fda-510k.jpg K982025 - HEWLETT-PACKARD M2475B WITH 12-LEAD OPTION (#C90) CODEMASTER 100 CONITOR/DEFIBRILLATOR K982025 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Sep 1998. https://www.510kdatabase.net/k982102/ 1998-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k982102-singleday-infusor-2-mlhr-elastomeric-fda-510k.jpg K982102 - SINGLEDAY INFUSOR 2 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL, INFUSOR SV 5 ML/HR (ELASTOMERIC INFUSION DEVICE) MODEL CY K982102 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Sep 1998. https://www.510kdatabase.net/k982672/ 1998-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k982672-colleague-pump-syringe-adapter-set-fda-510k.jpg K982672 - COLLEAGUE PUMP SYRINGE ADAPTER SET K982672 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Sep 1998. https://www.510kdatabase.net/k981981/ 1998-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k981981-electrosurgical-unit-esu-115-volt-fda-510k.jpg K981981 - ELECTROSURGICAL UNIT (ESU) (115 VOLT) MODEL 4810, ELECTROSURGICAL UNIT (ESU) (230 VOLT) MODEL 4811, INSTRUMENT CABLE, 19 K981981 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Boston Scientific Corp. Cleared Sep 1998. https://www.510kdatabase.net/k981994/ 1998-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k981994-vascath-opti-flow-long-term-dual-lumen-fda-510k.jpg K981994 - VASCATH OPTI-FLOW LONG TERM DUAL LUMEN HEMODIALYSIS CATHETER K981994 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Sep 1998. https://www.510kdatabase.net/k982089/ 1998-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k982089-accu-chek-advantage-test-strips-and-fda-510k.jpg K982089 - ACCU-CHEK ADVANTAGE TEST STRIPS AND ACCU-CHEK ADVANTAGE H TEST STRIPS K982089 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Sep 1998. https://www.510kdatabase.net/k974770/ 1998-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k974770-acqplan-fda-510k.jpg K974770 - ACQPLAN K974770 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Sep 1998. https://www.510kdatabase.net/k980686/ 1998-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k980686-aesculap-hilan-motor-system-fda-510k.jpg K980686 - AESCULAP HILAN MOTOR SYSTEM K980686 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Sep 1998. https://www.510kdatabase.net/k982002/ 1998-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k982002-accu-chek-comfort-curve-test-strip-fda-510k.jpg K982002 - ACCU-CHEK COMFORT CURVE TEST STRIP K982002 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Sep 1998. https://www.510kdatabase.net/k982068/ 1998-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k982068-howmedica-titanium-hoffmann-fixation-fda-510k.jpg K982068 - HOWMEDICA TITANIUM HOFFMANN FIXATION PIN SYSTEM K982068 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Aug 1998. https://www.510kdatabase.net/k982677/ 1998-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k982677-unimonopolar-hf-cable-fda-510k.jpg K982677 - UNI/MONOPOLAR HF CABLE K982677 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Aug 1998. https://www.510kdatabase.net/k982900/ 1998-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k982900-phantom-softhread-soft-tissue-fda-510k.jpg K982900 - PHANTOM SOFTHREAD SOFT TISSUE INTERFERENCE SCREW K982900 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Aug 1998. https://www.510kdatabase.net/k981653/ 1998-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k981653-amy-fda-510k.jpg K981653 - AMY K981653 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1998. https://www.510kdatabase.net/k982079/ 1998-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k982079-accu-check-voicemate-fda-510k.jpg K982079 - ACCU-CHECK VOICEMATE K982079 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Aug 1998. https://www.510kdatabase.net/k973943/ 1998-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k973943-instruments-for-endoscopic-subfascial-fda-510k.jpg K973943 - INSTRUMENTS FOR ENDOSCOPIC SUBFASCIAL HARVESTING OF VEINS (ESHV), INSTRUMENTS FOR ENDOSCOPIC SUBFASCIAL DISCISION OF PER K973943 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Aug 1998. https://www.510kdatabase.net/k980831/ 1998-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k980831-image-post-processing-techniques-fda-510k.jpg K980831 - IMAGE POST-PROCESSING TECHNIQUES K980831 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Aug 1998. https://www.510kdatabase.net/k981696/ 1998-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k981696-il-test-plasmin-inhibitor-fda-510k.jpg K981696 - IL TEST PLASMIN INHIBITOR K981696 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Aug 1998. https://www.510kdatabase.net/k982366/ 1998-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k982366-quanta-lite-ttg-tissue-fda-510k.jpg K982366 - QUANTA LITE TTG (TISSUE TRANSGLUTAMINASE) ELISA K982366 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Aug 1998. https://www.510kdatabase.net/k981897/ 1998-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k981897-roche-cobas-integra-alkaline-fda-510k.jpg K981897 - ROCHE COBAS INTEGRA ALKALINE PHOSPHATASE IFCC LIQUID REAGENT CASSETTE, ROCHE COBAS INTEGRA PANCREATIC A-AMYLASE EPS REAE K981897 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Aug 1998. https://www.510kdatabase.net/k982265/ 1998-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k982265-aquilion-ct-scanner-model-tsx-101a-fda-510k.jpg K982265 - AQUILION CT SCANNER, MODEL TSX-101A K982265 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Aug 1998. https://www.510kdatabase.net/k982880/ 1998-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k982880-dimensionr-valproic-valp-acid-method-fda-510k.jpg K982880 - DIMENSION(R) VALPROIC (VALP) ACID METHOD K982880 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Dade Behring, Inc.. Cleared Aug 1998. https://www.510kdatabase.net/k982367/ 1998-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k982367-reach-hip-component-fda-510k.jpg K982367 - REACH HIP COMPONENT K982367 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Aug 1998. https://www.510kdatabase.net/k982730/ 1998-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k982730-sc-7000-sc-9000-xl-infinity-modular-fda-510k.jpg K982730 - SC 7000 & SC 9000 XL INFINITY MODULAR BEDSIDE MONITOR K982730 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 1998. https://www.510kdatabase.net/k981120/ 1998-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k981120-zeus-scientific-inc-anti-ebv-ea-igg-fda-510k.jpg K981120 - ZEUS SCIENTIFIC INC., ANTI-EBV EA IGG ELISA K981120 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Aug 1998. https://www.510kdatabase.net/k980390/ 1998-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k980390-pta-balloon-catheter-fda-510k.jpg K980390 - PTA BALLOON CATHETER K980390 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Aug 1998. https://www.510kdatabase.net/k980884/ 1998-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k980884-siemens-sevoflurane-vaporizer-sv-953-fda-510k.jpg K980884 - SIEMENS SEVOFLURANE VAPORIZER SV 953 K980884 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 1998. https://www.510kdatabase.net/k981130/ 1998-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k981130-ksea-endo-tip-system-fda-510k.jpg K981130 - KSEA ENDO TIP SYSTEM K981130 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Aug 1998. https://www.510kdatabase.net/k982289/ 1998-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k982289-heat-probe-unit-hpu-20-heat-probe-cd-fda-510k.jpg K982289 - HEAT PROBE UNIT HPU-20, HEAT PROBE CD-110##/120## K982289 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus America, Inc.. Cleared Aug 1998. https://www.510kdatabase.net/k981890/ 1998-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k981890-synthes-usa-synthes-mmfs-20-mm-fda-510k.jpg K981890 - SYNTHES (USA) [SYNTHES] MMFS - 2.0 MM SAGITTAL SPLIT PLATES K981890 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Aug 1998. https://www.510kdatabase.net/k982004/ 1998-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k982004-ct-coronary-artery-calcification-fda-510k.jpg K982004 - CT CORONARY ARTERY CALCIFICATION SCORING (CACS) OPTION FOR ADVANTAGE WINDOWS K982004 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Aug 1998. https://www.510kdatabase.net/k982087/ 1998-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k982087-roche-crp-t-control-n-fda-510k.jpg K982087 - ROCHE CRP T CONTROL N K982087 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Aug 1998. https://www.510kdatabase.net/k982251/ 1998-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k982251-sigma-diagnostics-infinity-uric-acid-fda-510k.jpg K982251 - SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT K982251 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Aug 1998. https://www.510kdatabase.net/k982395/ 1998-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k982395-dytract-flow-restorative-fda-510k.jpg K982395 - DYTRACT FLOW RESTORATIVE K982395 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Aug 1998. https://www.510kdatabase.net/k982551/ 1998-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k982551-roche-c0bas-integra-serum-barbiturates-fda-510k.jpg K982551 - ROCHE C0BAS INTEGRA SERUM BARBITURATES REAGENT CASSETTE, ABUSCREEB ONLINE SERUM BARBITURATES CALIBRATORS, ROCHE COBAS IN K982551 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Aug 1998. https://www.510kdatabase.net/k982632/ 1998-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k982632-envoy-and-vista-brite-tip-fda-510k.jpg K982632 - ENVOY AND VISTA BRITE TIP K982632 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Aug 1998. https://www.510kdatabase.net/k982770/ 1998-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k982770-6f-envoy-guiding-catheter-fda-510k.jpg K982770 - 6F ENVOY GUIDING CATHETER K982770 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Aug 1998. https://www.510kdatabase.net/k981792/ 1998-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k981792-solution-administration-set-fda-510k.jpg K981792 - SOLUTION ADMINISTRATION SET K981792 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Aug 1998. https://www.510kdatabase.net/k982292/ 1998-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k982292-prealbumin-calibrator-fda-510k.jpg K982292 - PREALBUMIN CALIBRATOR K982292 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Aug 1998. https://www.510kdatabase.net/k980287/ 1998-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k980287-siemens-sc9000sc9015-tcp02c02-module-fda-510k.jpg K980287 - SIEMENS SC9000/SC9015 TCP02/C02 MODULE K980287 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 1998. https://www.510kdatabase.net/k982473/ 1998-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k982473-tumor-marker-control-fda-510k.jpg K982473 - TUMOR MARKER CONTROL K982473 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Aug 1998. https://www.510kdatabase.net/k982619/ 1998-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k982619-hp-anesthesia-gas-monitor-watertrap-fda-510k.jpg K982619 - HP ANESTHESIA GAS MONITOR (WATERTRAP), MODEL A02 K982619 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Aug 1998. https://www.510kdatabase.net/k982637/ 1998-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k982637-immulite-psa-control-module-model-lpscm-fda-510k.jpg K982637 - IMMULITE PSA CONTROL MODULE, MODEL LPSCM K982637 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Aug 1998. https://www.510kdatabase.net/k982398/ 1998-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k982398-biomet-100-porous-coated-biaxial-total-fda-510k.jpg K982398 - BIOMET 100% POROUS COATED BIAXIAL TOTAL ELBOW K982398 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Aug 1998. https://www.510kdatabase.net/k981647/ 1998-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k981647-3m-dent-ii-system-fda-510k.jpg K981647 - 3M DENT II SYSTEM K981647 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Aug 1998. https://www.510kdatabase.net/k974847/ 1998-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k974847-50mm-parachute-corkscrew-suture-anchor-fda-510k.jpg K974847 - 5.0MM PARACHUTE CORKSCREW SUTURE ANCHOR MODEL AR-22255, 3.5MM PARACHUTE CORKSCREW SUTURE ANCHOR MODEL AR-22235 K974847 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Aug 1998. https://www.510kdatabase.net/k981263/ 1998-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k981263-toxogen-fda-510k.jpg K981263 - TOXOGEN K981263 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Aug 1998. https://www.510kdatabase.net/k982011/ 1998-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k982011-depuy-motech-moss-miami-spinal-system-fda-510k.jpg K982011 - DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM K982011 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Aug 1998. https://www.510kdatabase.net/k982471/ 1998-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k982471-b2-microglobulin-control-set-serum-fda-510k.jpg K982471 - B2-MICROGLOBULIN CONTROL SET SERUM K982471 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Aug 1998. https://www.510kdatabase.net/k981628/ 1998-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k981628-bard-quantum-svr-model-number-h-6440vr-fda-510k.jpg K981628 - BARD QUANTUM SVR MODEL NUMBER H-6440VR K981628 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Aug 1998. https://www.510kdatabase.net/k982236/ 1998-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k982236-sigma-diagnostics-infinity-bun-reagent-fda-510k.jpg K982236 - SIGMA DIAGNOSTICS INFINITY BUN REAGENT KIT K982236 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Aug 1998. https://www.510kdatabase.net/k982591/ 1998-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k982591-dade-tru-liquid-cardiac-control-fda-510k.jpg K982591 - DADE TRU-LIQUID CARDIAC CONTROL K982591 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Aug 1998. https://www.510kdatabase.net/k981224/ 1998-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k981224-direct-hdl-fda-510k.jpg K981224 - DIRECT HDL K981224 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1998. https://www.510kdatabase.net/k981303/ 1998-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k981303-direct-ldl-fda-510k.jpg K981303 - DIRECT LDL K981303 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1998. https://www.510kdatabase.net/k981397/ 1998-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k981397-harmonic-imaging-and-flash-echo-fda-510k.jpg K981397 - HARMONIC IMAGING AND FLASH ECHO IMAGING FUNCTION FOR THE DIAGNOSTIC ULTRASOUND SYSTEM SSA-380A, POWERVISION 7000 K981397 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Jul 1998. https://www.510kdatabase.net/k981620/ 1998-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k981620-mta-material-ii-fda-510k.jpg K981620 - MTA MATERIAL II K981620 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jul 1998. https://www.510kdatabase.net/k981713/ 1998-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k981713-cicanet-wound-contact-layer-dressing-2-fda-510k.jpg K981713 - CICANET WOUND CONTACT LAYER DRESSING - 2 X 3 IN. MODEL 59100600, CICANET WOUND CONTACT LAYER DRESSING - 4 X 5 IN. MODEL0 K981713 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 1998. https://www.510kdatabase.net/k981959/ 1998-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k981959-outlook-large-phased-array-neck-coil-fda-510k.jpg K981959 - OUTLOOK LARGE PHASED ARRAY NECK COIL K981959 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Jul 1998. https://www.510kdatabase.net/k982502/ 1998-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k982502-genesis-imrt-linear-accelerator-fda-510k.jpg K982502 - GENESIS IMRT LINEAR ACCELERATOR K982502 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 1998. https://www.510kdatabase.net/k982513/ 1998-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k982513-mx-mevatron-fda-510k.jpg K982513 - MX MEVATRON K982513 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 1998. https://www.510kdatabase.net/k980821/ 1998-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k980821-helicobacter-pylori-igg-elisa-test-fda-510k.jpg K980821 - HELICOBACTER PYLORI IGG ELISA TEST SYSTEM K980821 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Jul 1998. https://www.510kdatabase.net/k982041/ 1998-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k982041-uibc-fda-510k.jpg K982041 - UIBC K982041 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jul 1998. https://www.510kdatabase.net/k981857/ 1998-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k981857-quanta-lite-tpo-elisa-fda-510k.jpg K981857 - QUANTA LITE TPO ELISA K981857 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Jul 1998. https://www.510kdatabase.net/k982222/ 1998-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k982222-synthes-usa-distal-femur-plate-dfp-fda-510k.jpg K982222 - SYNTHES (USA) DISTAL FEMUR PLATE (DFP) SYSTEM K982222 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jul 1998. https://www.510kdatabase.net/k981918/ 1998-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k981918-urea-fda-510k.jpg K981918 - UREA K981918 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jul 1998. https://www.510kdatabase.net/k981654/ 1998-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k981654-tibc-fda-510k.jpg K981654 - TIBC K981654 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jul 1998. https://www.510kdatabase.net/k981799/ 1998-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k981799-crea-fda-510k.jpg K981799 - CREA K981799 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jul 1998. https://www.510kdatabase.net/k981814/ 1998-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k981814-albp-fda-510k.jpg K981814 - ALBP K981814 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jul 1998. https://www.510kdatabase.net/k981920/ 1998-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k981920-amm-fda-510k.jpg K981920 - AMM K981920 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jul 1998. https://www.510kdatabase.net/k981943/ 1998-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k981943-dbil-fda-510k.jpg K981943 - DBIL K981943 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jul 1998. https://www.510kdatabase.net/k982007/ 1998-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k982007-trubyte-denture-bond-denture-bonding-fda-510k.jpg K982007 - TRUBYTE DENTURE BOND DENTURE BONDING AGENT K982007 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jul 1998. https://www.510kdatabase.net/k980302/ 1998-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k980302-working-elements-resectoscope-sheaths-fda-510k.jpg K980302 - WORKING ELEMENTS, RESECTOSCOPE SHEATHS, ELECTRODES, OBTURATORS, ENDOSCOPES K980302 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Jul 1998. https://www.510kdatabase.net/k973430/ 1998-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k973430-kodak-pro-medical-digital-camera-system-fda-510k.jpg K973430 - KODAK PRO-MEDICAL DIGITAL CAMERA SYSTEM K973430 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Eastman Kodak Company. Cleared Jul 1998. https://www.510kdatabase.net/k980185/ 1998-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k980185-colorpac-toxin-a-fda-510k.jpg K980185 - COLORPAC TOXIN A K980185 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jul 1998. https://www.510kdatabase.net/k980778/ 1998-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k980778-hakim-micro-programmable-valve-system-fda-510k.jpg K980778 - HAKIM MICRO PROGRAMMABLE VALVE SYSTEM K980778 is a FDA 510(k) cleared neurology medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jul 1998. https://www.510kdatabase.net/k981417/ 1998-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k981417-squirt-fluid-delivery-system-fda-510k.jpg K981417 - Squirt Fluid Delivery System K981417 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jul 1998. https://www.510kdatabase.net/k981757/ 1998-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k981757-synthes-usa-dhs-helix-system-fda-510k.jpg K981757 - SYNTHES (USA) DHS HELIX SYSTEM K981757 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jul 1998. https://www.510kdatabase.net/k981847/ 1998-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k981847-biolox-alumina-ceramic-femoral-head-fda-510k.jpg K981847 - BIOLOX ALUMINA CERAMIC FEMORAL HEAD K981847 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 1998. https://www.510kdatabase.net/k981406/ 1998-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k981406-cervix-coil-latex-sheath-fda-510k.jpg K981406 - CERVIX COIL LATEX SHEATH K981406 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Jul 1998. https://www.510kdatabase.net/k972728/ 1998-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k972728-sterile-water-for-injection-prefilled-fda-510k.jpg K972728 - STERILE WATER FOR INJECTION PREFILLED SYRING (SWFIPS) K972728 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jul 1998. https://www.510kdatabase.net/k981546/ 1998-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k981546-nti-clenching-suppression-system-fda-510k.jpg K981546 - NTI CLENCHING SUPPRESSION SYSTEM K981546 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Jul 1998. https://www.510kdatabase.net/k974457/ 1998-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k974457-scout-3245-mhz-coronary-imaging-fda-510k.jpg K974457 - SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT 3.2/45 MHZ CORONARY IMAGING CATHETER, SCOUT IMAGING CATHETER PATIENT T K974457 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Jul 1998. https://www.510kdatabase.net/k981459/ 1998-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k981459-membrane-tack-fda-510k.jpg K981459 - MEMBRANE TACK K981459 is a FDA 510(k) cleared dental medical device. Manufacturer: Biomet, Inc.. Cleared Jul 1998. https://www.510kdatabase.net/k982028/ 1998-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k982028-fluorospot-compact-fda-510k.jpg K982028 - FLUOROSPOT COMPACT K982028 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 1998. https://www.510kdatabase.net/k982250/ 1998-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k982250-access-free-t4-reagents-on-the-access-fda-510k.jpg K982250 - ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER K982250 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jul 1998. https://www.510kdatabase.net/k972401/ 1998-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k972401-howmedica-modular-replacement-system-fda-510k.jpg K972401 - HOWMEDICA MODULAR REPLACEMENT SYSTEM - DISTAL FEMORAL/PROXIMAL TIBIAL SEGMENTS K972401 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jul 1998. https://www.510kdatabase.net/k981361/ 1998-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k981361-powerstar-bipolar-scissors-fda-510k.jpg K981361 - POWERSTAR BIPOLAR SCISSORS K981361 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Jul 1998. https://www.510kdatabase.net/k981487/ 1998-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k981487-depuy-global-shoulder-glenoid-fda-510k.jpg K981487 - DEPUY GLOBAL SHOULDER GLENOID K981487 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jul 1998. https://www.510kdatabase.net/k981798/ 1998-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k981798-lactosorb-pop-rivet-fda-510k.jpg K981798 - LACTOSORB POP RIVET K981798 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jul 1998. https://www.510kdatabase.net/k974652/ 1998-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k974652-blood-monitor-pump-with-fda-510k.jpg K974652 - BLOOD MONITOR PUMP WITH ULTRAFILTRATION CONTROLLER K974652 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jul 1998. https://www.510kdatabase.net/k981965/ 1998-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k981965-flowable-composite-fda-510k.jpg K981965 - FLOWABLE COMPOSITE K981965 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jul 1998. https://www.510kdatabase.net/k981529/ 1998-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k981529-titanium-intramedullary-nail-titanium-fda-510k.jpg K981529 - TITANIUM INTRAMEDULLARY NAIL, TITANIUM LOCKING SCREW K981529 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 1998. https://www.510kdatabase.net/k981579/ 1998-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k981579-endopouch-pro-specimen-retrieval-bag-fda-510k.jpg K981579 - ENDOPOUCH PRO SPECIMEN RETRIEVAL BAG K981579 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Jul 1998. https://www.510kdatabase.net/k981706/ 1998-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k981706-amm-cal-bil-cal-co2-cal-hdl-cal-ironmg-fda-510k.jpg K981706 - AMM CAL, BIL CAL, CO2 CAL, HDL CAL, IRON/MG CAL, LDL CAL, MC CAL, UPRO CAL, AND ISE CALIBRATOR LEVELS 1 AND 2 K981706 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jul 1998. https://www.510kdatabase.net/k982032/ 1998-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k982032-osteonics-omnifit-ha-hip-stem-series-fda-510k.jpg K982032 - OSTEONICS OMNIFIT HA HIP STEM SERIES, OSTEONICS SECUR-FIT HA HIP STEM SERIES, OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS K982032 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Jul 1998. https://www.510kdatabase.net/k982210/ 1998-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k982210-modification-of-syva-microtrak-ii-fda-510k.jpg K982210 - MODIFICATION OF SYVA MICROTRAK II CHLAMYDIA EIA K982210 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Dade Behring, Inc.. Cleared Jul 1998. https://www.510kdatabase.net/k982224/ 1998-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k982224-vigil-protein-control-fda-510k.jpg K982224 - VIGIL PROTEIN CONTROL K982224 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jul 1998. https://www.510kdatabase.net/k974698/ 1998-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k974698-siemens-sc9000sc9015-enhanced-with-12-fda-510k.jpg K974698 - SIEMENS SC9000/SC9015 ENHANCED WITH 12-LEAD ST SEGMENT ANALYSIS K974698 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 1998. https://www.510kdatabase.net/k981615/ 1998-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k981615-ksea-uropump-fda-510k.jpg K981615 - KSEA UROPUMP K981615 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jul 1998. https://www.510kdatabase.net/k981321/ 1998-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k981321-bipolar-forceps-set-modular-fda-510k.jpg K981321 - BIPOLAR FORCEPS SET (MODULAR) K981321 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Jul 1998. https://www.510kdatabase.net/k981479/ 1998-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k981479-il-test-pt-fibrinogen-recombinant-fda-510k.jpg K981479 - IL TEST PT-FIBRINOGEN RECOMBINANT K981479 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jul 1998. https://www.510kdatabase.net/k981883/ 1998-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k981883-roche-diagnostics-boehringer-mannheim-fda-510k.jpg K981883 - ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION LIQUID DIRECT BILIRUBIN REAGENT, CATALOG NUMBER 1877844 K981883 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jul 1998. https://www.510kdatabase.net/k974715/ 1998-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k974715-advantage-3d-xr-fda-510k.jpg K974715 - ADVANTAGE 3D XR K974715 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Jul 1998. https://www.510kdatabase.net/k982022/ 1998-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k982022-vigil-hemoglobin-hbalc-controls-fda-510k.jpg K982022 - VIGIL HEMOGLOBIN (HBALC) CONTROLS K982022 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jul 1998. https://www.510kdatabase.net/k974739/ 1998-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k974739-hakim-programmable-valve-system-fda-510k.jpg K974739 - HAKIM PROGRAMMABLE VALVE SYSTEM K974739 is a FDA 510(k) cleared neurology medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jul 1998. https://www.510kdatabase.net/k981187/ 1998-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k981187-acl-avulsion-lag-screw-with-sheath-fda-510k.jpg K981187 - ACL AVULSION LAG SCREW WITH SHEATH MODEL NUMBER AR-6001 K981187 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jul 1998. https://www.510kdatabase.net/k981190/ 1998-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k981190-high-impedance-cardiac-gating-cable-fda-510k.jpg K981190 - HIGH IMPEDANCE CARDIAC GATING CABLE K981190 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Jun 1998. https://www.510kdatabase.net/k981410/ 1998-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k981410-hammersmith-endocavitary-coils-fda-510k.jpg K981410 - HAMMERSMITH ENDOCAVITARY COILS K981410 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Jun 1998. https://www.510kdatabase.net/k980887/ 1998-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k980887-elecsys-cea-on-the-elecsys-1010-fda-510k.jpg K980887 - ELECSYS CEA ON THE ELECSYS 1010 K980887 is a FDA 510(k) cleared immunology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jun 1998. https://www.510kdatabase.net/k981342/ 1998-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k981342-abbott-cell-dyn-4000-immunopit-cd61-fda-510k.jpg K981342 - ABBOTT CELL-DYN 4000 IMMUNOPIT (CD61) ASSAY K981342 is a FDA 510(k) cleared hematology medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1998. https://www.510kdatabase.net/k981362/ 1998-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k981362-synthes-usa-external-multi-vector-fda-510k.jpg K981362 - SYNTHES (USA) EXTERNAL MULTI VECTOR MANDIBLE DISTRACTOR K981362 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Jun 1998. https://www.510kdatabase.net/k981652/ 1998-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k981652-chol-fda-510k.jpg K981652 - CHOL K981652 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1998. https://www.510kdatabase.net/k981843/ 1998-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k981843-ast-fda-510k.jpg K981843 - AST K981843 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1998. https://www.510kdatabase.net/k981906/ 1998-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k981906-modification-for-pta-balloon-catheter-fda-510k.jpg K981906 - MODIFICATION FOR PTA BALLOON CATHETER K981906 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Jun 1998. https://www.510kdatabase.net/k974178/ 1998-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k974178-passport-5l-ce-model-0998-00-0131xxx-fda-510k.jpg K974178 - PASSPORT 5L-CE MODEL 0998-00-0131XXX K974178 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Jun 1998. https://www.510kdatabase.net/k980580/ 1998-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k980580-becton-dickinson-syringes-fda-510k.jpg K980580 - BECTON DICKINSON SYRINGES K980580 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jun 1998. https://www.510kdatabase.net/k981115/ 1998-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k981115-radio-plast-fda-510k.jpg K981115 - RADIO-PLAST K981115 is a FDA 510(k) cleared radiology medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jun 1998. https://www.510kdatabase.net/k981275/ 1998-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k981275-synthes-usa-ratcheting-distractor-fda-510k.jpg K981275 - SYNTHES (USA) RATCHETING DISTRACTOR K981275 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Jun 1998. https://www.510kdatabase.net/k981476/ 1998-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k981476-chol-fda-510k.jpg K981476 - CHOL K981476 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1998. https://www.510kdatabase.net/k981935/ 1998-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k981935-polysorb-suture-fda-510k.jpg K981935 - POLYSORB SUTURE K981935 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Jun 1998. https://www.510kdatabase.net/k981265/ 1998-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k981265-pagewriter-200i-interpretive-fda-510k.jpg K981265 - PAGEWRITER 200I INTERPRETIVE CARDIOGRAPH MODEL M1770A WITH ACUTE CARDIAC ISCHEMIA TIME INSENSITIVE PREDICTIVE INSTRUMENA K981265 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Jun 1998. https://www.510kdatabase.net/k973251/ 1998-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k973251-ksea-calcuson-fda-510k.jpg K973251 - KSEA CALCUSON K973251 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jun 1998. https://www.510kdatabase.net/k981075/ 1998-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k981075-synthes-usa-synthes-single-vector-fda-510k.jpg K981075 - SYNTHES (USA) (SYNTHES) SINGLE VECTOR DISTRACTOR WITH DETACHABLE FEET K981075 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Jun 1998. https://www.510kdatabase.net/k981150/ 1998-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k981150-solosite-gel-conformable-dressing-fda-510k.jpg K981150 - SOLOSITE GEL CONFORMABLE DRESSING K981150 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jun 1998. https://www.510kdatabase.net/k981261/ 1998-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k981261-howmedica-scn-nail-fda-510k.jpg K981261 - HOWMEDICA SCN NAIL K981261 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jun 1998. https://www.510kdatabase.net/k981309/ 1998-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k981309-osteo-i-c-humeral-nail-system-fda-510k.jpg K981309 - OSTEO I-C HUMERAL NAIL SYSTEM K981309 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Jun 1998. https://www.510kdatabase.net/k981467/ 1998-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k981467-amm-fda-510k.jpg K981467 - AMM K981467 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1998. https://www.510kdatabase.net/k981670/ 1998-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k981670-depuy-profile-round-head-interference-fda-510k.jpg K981670 - DEPUY PROFILE ROUND HEAD INTERFERENCE SCREW AND DEPUY PHANTOM RESORBABLE INTERFERENCE SCREW K981670 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jun 1998. https://www.510kdatabase.net/k981806/ 1998-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k981806-alkp-fda-510k.jpg K981806 - ALKP K981806 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1998. https://www.510kdatabase.net/k981328/ 1998-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k981328-quanta-lite-pr3-igg-serine-protease-fda-510k.jpg K981328 - QUANTA LITE PR3 IGG (SERINE PROTEASE) TEST KIT K981328 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Jun 1998. https://www.510kdatabase.net/k981330/ 1998-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k981330-quanta-lite-mpo-igg-myeloperoxidase-fda-510k.jpg K981330 - QUANTA LITE MPO IGG (MYELOPEROXIDASE) TEST KIT K981330 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Jun 1998. https://www.510kdatabase.net/k981766/ 1998-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k981766-uric-acid-fda-510k.jpg K981766 - URIC ACID K981766 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1998. https://www.510kdatabase.net/k974843/ 1998-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k974843-duraconr-small-stabilizer-tibial-insert-fda-510k.jpg K974843 - DURACON(R) SMALL STABILIZER TIBIAL INSERT K974843 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jun 1998. https://www.510kdatabase.net/k981053/ 1998-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k981053-kodak-digital-sciences-kds-image-view-fda-510k.jpg K981053 - KODAK DIGITAL SCIENCES (KDS) IMAGE VIEW K981053 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Jun 1998. https://www.510kdatabase.net/k981217/ 1998-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k981217-platinum-reading-review-analysis-fda-510k.jpg K981217 - PLATINUM READING, REVIEW & ANALYSIS WORKSTATION K981217 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Jun 1998. https://www.510kdatabase.net/k981578/ 1998-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k981578-ca-fda-510k.jpg K981578 - CA K981578 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1998. https://www.510kdatabase.net/k981759/ 1998-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k981759-phos-fda-510k.jpg K981759 - PHOS K981759 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1998. https://www.510kdatabase.net/k974087/ 1998-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k974087-model-m1792a-thrombolytic-predictive-fda-510k.jpg K974087 - MODEL M1792A THROMBOLYTIC PREDICTIVE INSTRUMENT K974087 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Jun 1998. https://www.510kdatabase.net/k981233/ 1998-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k981233-ksea-calcusplit-fda-510k.jpg K981233 - KSEA CALCUSPLIT K981233 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jun 1998. https://www.510kdatabase.net/k981056/ 1998-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k981056-varian-ximatron-scan-vision-ct-fda-510k.jpg K981056 - VARIAN XIMATRON SCAN VISION CT K981056 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Jun 1998. https://www.510kdatabase.net/k981118/ 1998-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k981118-phos-fda-510k.jpg K981118 - PHOS K981118 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1998. https://www.510kdatabase.net/k981638/ 1998-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k981638-immage-immunochemistry-system-c-fda-510k.jpg K981638 - IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT K981638 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jun 1998. https://www.510kdatabase.net/k981758/ 1998-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k981758-albg-fda-510k.jpg K981758 - ALBG K981758 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1998. https://www.510kdatabase.net/k981797/ 1998-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k981797-b-d-pen-ultra-fda-510k.jpg K981797 - B-D PEN ULTRA K981797 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jun 1998. https://www.510kdatabase.net/k981864/ 1998-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k981864-access-afp-qc-on-the-access-fda-510k.jpg K981864 - ACCESS AFP QC ON THE ACCESS IMMUNOASSAY ANALYZER, MODEL NUMBER 33219 K981864 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jun 1998. https://www.510kdatabase.net/k980987/ 1998-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k980987-becton-dickinson-syringe-fda-510k.jpg K980987 - BECTON DICKINSON SYRINGE K980987 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jun 1998. https://www.510kdatabase.net/k981325/ 1998-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k981325-3m-mg-material-fda-510k.jpg K981325 - 3M M.G. MATERIAL K981325 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Jun 1998. https://www.510kdatabase.net/k981580/ 1998-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k981580-hdl-fda-510k.jpg K981580 - HDL K981580 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1998. https://www.510kdatabase.net/k973812/ 1998-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k973812-arthrex-puddu-osteotomy-system-fda-510k.jpg K973812 - ARTHREX PUDDU OSTEOTOMY SYSTEM K973812 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jun 1998. https://www.510kdatabase.net/k980121/ 1998-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k980121-aesculap-spine-system-additional-fda-510k.jpg K980121 - AESCULAP SPINE SYSTEM ADDITIONAL COMPONENTS K980121 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aesculap, Inc.. Cleared Jun 1998. https://www.510kdatabase.net/k981495/ 1998-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k981495-immulite-ck-mb-catalog-lkcp1-100-tests-fda-510k.jpg K981495 - IMMULITE CK-MB, CATALOG # LKCP1 (100 TESTS), LKCP5 (500 TESTS) K981495 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jun 1998. https://www.510kdatabase.net/k981590/ 1998-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k981590-liquichek-urine-toxicology-control-fda-510k.jpg K981590 - LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C1, LIQUICHEK URINE TOXICOLOGY CONTROL LEVEL C2, LIQUICHEK URINE TOXICOLOGY CON K981590 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bio-Rad. Cleared Jun 1998. https://www.510kdatabase.net/k980653/ 1998-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k980653-perflex-stainless-steel-stent-and-fda-510k.jpg K980653 - PERFLEX STAINLESS STEEL STENT AND DELIVERY SYSTEM K980653 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Jun 1998. https://www.510kdatabase.net/k981743/ 1998-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k981743-olympus-au400-clinical-chemistry-fda-510k.jpg K981743 - OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER K981743 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus America, Inc.. Cleared Jun 1998. https://www.510kdatabase.net/k974292/ 1998-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k974292-nihon-kohden-tl-101t-tl-120t-and-tl-fda-510k.jpg K974292 - NIHON KOHDEN TL-101T, TL-120T AND TL-121T SPO2 PROBES AND ACCESSORIES K974292 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Jun 1998. https://www.510kdatabase.net/k981216/ 1998-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k981216-amy-fda-510k.jpg K981216 - AMY K981216 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1998. https://www.510kdatabase.net/k981581/ 1998-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k981581-iron-fda-510k.jpg K981581 - IRON K981581 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1998. https://www.510kdatabase.net/k981622/ 1998-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k981622-dade-tru-liquid-cardiac-control-fda-510k.jpg K981622 - DADE TRU-LIQUID CARDIAC CONTROL K981622 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Jun 1998. https://www.510kdatabase.net/k981840/ 1998-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k981840-co2-fda-510k.jpg K981840 - CO2 K981840 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1998. https://www.510kdatabase.net/k980882/ 1998-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k980882-siemens-sc-7000-sc-9000-xl-infinity-fda-510k.jpg K980882 - SIEMENS SC 7000 & SC 9000 XL INFINITY MODULAR BEDSIDE MONITOR K980882 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 1998. https://www.510kdatabase.net/k980927/ 1998-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k980927-lactosorb-panels-and-fasteners-fda-510k.jpg K980927 - LACTOSORB PANELS AND FASTENERS K980927 is a FDA 510(k) cleared dental medical device. Manufacturer: Biomet, Inc.. Cleared Jun 1998. https://www.510kdatabase.net/k980996/ 1998-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k980996-cobas-integra-carbon-dioxide-co2-s-fda-510k.jpg K980996 - COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF) K980996 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jun 1998. https://www.510kdatabase.net/k981237/ 1998-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k981237-quanta-lite-ribosome-p-elisa-fda-510k.jpg K981237 - QUANTA LITE RIBOSOME P ELISA K981237 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Jun 1998. https://www.510kdatabase.net/k981669/ 1998-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k981669-speedband-superview-multiple-band-fda-510k.jpg K981669 - SPEEDBAND SUPERVIEW MULTIPLE BAND LIGATOR K981669 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Jun 1998. https://www.510kdatabase.net/k974363/ 1998-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k974363-becton-dickinson-blunt-plastic-cannula-fda-510k.jpg K974363 - BECTON DICKINSON BLUNT PLASTIC CANNULA K974363 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jun 1998. https://www.510kdatabase.net/k980850/ 1998-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k980850-bard-9fr-40cc-rediguard-and-taperseal-fda-510k.jpg K980850 - BARD 9FR., 40CC. REDIGUARD AND TAPERSEAL INTRA-AORTIC BALLOONS K980850 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jun 1998. https://www.510kdatabase.net/k980918/ 1998-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k980918-jpacs-fda-510k.jpg K980918 - JPACS K980918 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Jun 1998. https://www.510kdatabase.net/k981014/ 1998-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k981014-zeus-scientific-inc-anti-cardiolipin-fda-510k.jpg K981014 - ZEUS SCIENTIFIC, INC. ANTI-CARDIOLIPIN IGG ELISA TEST SYSTEM K981014 is a FDA 510(k) cleared immunology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Jun 1998. https://www.510kdatabase.net/k981021/ 1998-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k981021-zeus-anti-cardiolipin-igm-test-system-fda-510k.jpg K981021 - ZEUS ANTI-CARDIOLIPIN IGM TEST SYSTEM K981021 is a FDA 510(k) cleared immunology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Jun 1998. https://www.510kdatabase.net/k974678/ 1998-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k974678-b-d-auto-injector-fda-510k.jpg K974678 - B-D AUTO-INJECTOR K974678 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared May 1998. https://www.510kdatabase.net/k980780/ 1998-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k980780-datascope-percor-stat-dl-95-fr-25-34-fda-510k.jpg K980780 - DATASCOPE PERCOR STAT-DL 9.5 FR. 25, 34 AND 40CC INTRA-AORIC BALLOONS WITH ALTERNATE B MEMBRANE FOR OPTIONAL SHEATHLES K980780 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared May 1998. https://www.510kdatabase.net/k980801/ 1998-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k980801-j-fx-bipolar-head-fda-510k.jpg K980801 - J-FX BIPOLAR HEAD K980801 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared May 1998. https://www.510kdatabase.net/k981201/ 1998-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k981201-osteolock-acetabular-cup-fda-510k.jpg K981201 - OSTEOLOCK ACETABULAR CUP K981201 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared May 1998. https://www.510kdatabase.net/k981240/ 1998-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k981240-creatinine-crea-fda-510k.jpg K981240 - CREATININE (CREA) K981240 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared May 1998. https://www.510kdatabase.net/k981584/ 1998-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k981584-abuscreen-online-for-cannabinoids-100-fda-510k.jpg K981584 - ABUSCREEN ONLINE FOR CANNABINOIDS (100 TEST KIT) K981584 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared May 1998. https://www.510kdatabase.net/k981585/ 1998-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k981585-abuscreen-online-for-cannabinoids-1000-fda-510k.jpg K981585 - ABUSCREEN ONLINE FOR CANNABINOIDS (1000 TEST KIT) K981585 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared May 1998. https://www.510kdatabase.net/k980766/ 1998-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k980766-osteonics-anteverted-neck-ha-hip-stems-fda-510k.jpg K980766 - OSTEONICS ANTEVERTED NECK HA HIP STEMS K980766 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared May 1998. https://www.510kdatabase.net/k981468/ 1998-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k981468-albg-fda-510k.jpg K981468 - ALBG K981468 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared May 1998. https://www.510kdatabase.net/k981626/ 1998-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k981626-sonoline-elegra-diagnostic-ultrasound-fda-510k.jpg K981626 - SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM K981626 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 1998. https://www.510kdatabase.net/k973360/ 1998-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k973360-medtronic-model-6416-transvenous-fda-510k.jpg K973360 - MEDTRONIC MODEL 6416 TRANSVENOUS BIPOLAR TEMPORARY PACING LEAD K973360 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared May 1998. https://www.510kdatabase.net/k980746/ 1998-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k980746-cedia-dau-eddp-assay-fda-510k.jpg K980746 - CEDIA DAU EDDP ASSAY K980746 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared May 1998. https://www.510kdatabase.net/k981099/ 1998-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k981099-stratus-cs-stat-fluorometric-analyzer-fda-510k.jpg K981099 - STRATUS CS STAT FLUOROMETRIC ANALYZER AND STRATUS CS CKMB TESTPAK K981099 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared May 1998. https://www.510kdatabase.net/k981200/ 1998-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k981200-il-test-plasminogen-fda-510k.jpg K981200 - IL TEST PLASMINOGEN K981200 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared May 1998. https://www.510kdatabase.net/k980687/ 1998-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k980687-sonos-5500-ultrasound-imaging-system-fda-510k.jpg K980687 - SONOS 5500 ULTRASOUND IMAGING SYSTEM K980687 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared May 1998. https://www.510kdatabase.net/k980713/ 1998-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k980713-femoral-and-tibial-plugs-of-interax-fda-510k.jpg K980713 - FEMORAL AND TIBIAL PLUGS OF INTERAX TOTAL KNEE SYSTEM K980713 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared May 1998. https://www.510kdatabase.net/k980731/ 1998-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k980731-accu-chek-comfort-curve-test-strips-fda-510k.jpg K980731 - ACCU-CHEK COMFORT CURVE TEST STRIPS K980731 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared May 1998. https://www.510kdatabase.net/k974571/ 1998-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k974571-solution-administration-set-with-fda-510k.jpg K974571 - SOLUTION ADMINISTRATION SET WITH CAPPED LUER ACTIVATED VALVE K974571 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared May 1998. https://www.510kdatabase.net/k974695/ 1998-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k974695-cobras-integra-acid-prostatic-fda-510k.jpg K974695 - COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES WITH B-GLUCURONIDASE (BNZGL) K974695 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared May 1998. https://www.510kdatabase.net/k980401/ 1998-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k980401-flexible-fiberscopes-and-accessories-fda-510k.jpg K980401 - FLEXIBLE FIBERSCOPES AND ACCESSORIES K980401 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared May 1998. https://www.510kdatabase.net/k974513/ 1998-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k974513-pinpoint-fda-510k.jpg K974513 - PINPOINT K974513 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared May 1998. https://www.510kdatabase.net/k980665/ 1998-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k980665-repicci-ii-unicondylar-knee-all-poly-fda-510k.jpg K980665 - REPICCI II UNICONDYLAR KNEE ALL POLY TIBIAL COMPONENTS K980665 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared May 1998. https://www.510kdatabase.net/k980794/ 1998-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k980794-dual-lock-hip-stem-fda-510k.jpg K980794 - DUAL LOCK HIP STEM K980794 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared May 1998. https://www.510kdatabase.net/k980841/ 1998-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k980841-rci-fixation-screws-fda-510k.jpg K980841 - RCI FIXATION SCREWS K980841 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared May 1998. https://www.510kdatabase.net/k980862/ 1998-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k980862-titanium-spinal-rod-system-fda-510k.jpg K980862 - TITANIUM SPINAL ROD SYSTEM K980862 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared May 1998. https://www.510kdatabase.net/k981070/ 1998-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k981070-20-hole-adaptation-plate-fda-510k.jpg K981070 - 20-HOLE ADAPTATION PLATE K981070 is a FDA 510(k) cleared dental medical device. Manufacturer: Biomet, Inc.. Cleared May 1998. https://www.510kdatabase.net/k981156/ 1998-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k981156-dyonics-intelijet-inflowoutflow-cannula-fda-510k.jpg K981156 - DYONICS INTELIJET INFLOW/OUTFLOW CANNULA K981156 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared May 1998. https://www.510kdatabase.net/k981245/ 1998-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k981245-alkaline-phosphatase-alkp-fda-510k.jpg K981245 - ALKALINE PHOSPHATASE (ALKP) K981245 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared May 1998. https://www.510kdatabase.net/k981279/ 1998-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k981279-tibc-fda-510k.jpg K981279 - TIBC K981279 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared May 1998. https://www.510kdatabase.net/k981407/ 1998-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k981407-opta-lp-pta-balloon-catheterpowerflex-fda-510k.jpg K981407 - OPTA LP PTA BALLOON CATHETER/POWERFLEX PLUS PTA BALLOON CATHETER K981407 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared May 1998. https://www.510kdatabase.net/k981452/ 1998-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k981452-osteonics-long-arm-containment-ring-fda-510k.jpg K981452 - OSTEONICS LONG ARM CONTAINMENT RING K981452 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared May 1998. https://www.510kdatabase.net/k980604/ 1998-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k980604-smith-nephew-dyonics-endoscopes-and-fda-510k.jpg K980604 - SMITH & NEPHEW DYONICS ENDOSCOPES AND ACCESSORIES K980604 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared May 1998. https://www.510kdatabase.net/k980625/ 1998-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k980625-siemens-multiview-workstation-enhanced-fda-510k.jpg K980625 - SIEMENS MULTIVIEW WORKSTATION ENHANCED WITH DIAGNOSTIC STATEMENTS (REST ECG) K980625 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 1998. https://www.510kdatabase.net/k980656/ 1998-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k980656-psn-dialyzer-model-psn-170r5m4235-psn-fda-510k.jpg K980656 - PSN DIALYZER, MODEL PSN-170/R5M4235, PSN-210/R5M236 K980656 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared May 1998. https://www.510kdatabase.net/k980658/ 1998-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k980658-psn-dialyzer-model-psn-130r5m4233-fda-510k.jpg K980658 - PSN DIALYZER, MODEL PSN 130/R5M4233, MODEL PSN-150/R5M4234 K980658 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared May 1998. https://www.510kdatabase.net/k981020/ 1998-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k981020-zeus-anti-cardiolipin-igs-elisa-test-fda-510k.jpg K981020 - ZEUS ANTI-CARDIOLIPIN IGS ELISA TEST SYSTEM K981020 is a FDA 510(k) cleared immunology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared May 1998. https://www.510kdatabase.net/k981338/ 1998-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k981338-ld-1-fda-510k.jpg K981338 - LD-1 K981338 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared May 1998. https://www.510kdatabase.net/k981401/ 1998-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k981401-boehringer-mannheim-precinorm-fda-510k.jpg K981401 - BOEHRINGER MANNHEIM PRECINORM PRECIPATH PROTEIN CONTROLS K981401 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared May 1998. https://www.510kdatabase.net/k980014/ 1998-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k980014-the-system-2s-steam-sterilizer-fda-510k.jpg K980014 - THE SYSTEM 2S STEAM STERILIZER K980014 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared May 1998. https://www.510kdatabase.net/k980575/ 1998-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k980575-siteseer-angiographic-catheter-fda-510k.jpg K980575 - SITESEER ANGIOGRAPHIC CATHETER K980575 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 1998. https://www.510kdatabase.net/k971421/ 1998-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k971421-bard-isoflow-blood-pump-fda-510k.jpg K971421 - BARD ISOFLOW BLOOD PUMP K971421 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 1998. https://www.510kdatabase.net/k973920/ 1998-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k973920-stardust-fda-510k.jpg K973920 - STARDUST K973920 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared May 1998. https://www.510kdatabase.net/k980935/ 1998-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k980935-capiox-sx-hardshell-reservoir-fda-510k.jpg K980935 - CAPIOX SX HARDSHELL RESERVOIR K980935 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared May 1998. https://www.510kdatabase.net/k974491/ 1998-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k974491-accu-chek-a1c-hemoglobin-test-fda-510k.jpg K974491 - ACCU-CHEK A1C HEMOGLOBIN TEST K974491 is a FDA 510(k) cleared hematology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared May 1998. https://www.510kdatabase.net/k981455/ 1998-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k981455-third-generation-psa-control-module-fda-510k.jpg K981455 - THIRD GENERATION PSA CONTROL MODULE K981455 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared May 1998. https://www.510kdatabase.net/k980671/ 1998-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k980671-coloscreen-es-fda-510k.jpg K980671 - COLOSCREEN-ES K980671 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared May 1998. https://www.510kdatabase.net/k981532/ 1998-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k981532-lyphochek-immunoassay-plus-control-fda-510k.jpg K981532 - LYPHOCHEK IMMUNOASSAY PLUS CONTROL K981532 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared May 1998. https://www.510kdatabase.net/k974560/ 1998-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k974560-cordis-vanguard-steerable-guidewires-fda-510k.jpg K974560 - CORDIS VANGUARD STEERABLE GUIDEWIRES K974560 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared May 1998. https://www.510kdatabase.net/k980595/ 1998-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k980595-depuy-orthotech-catera-suture-anchor-fda-510k.jpg K980595 - DEPUY ORTHOTECH CATERA SUTURE ANCHOR K980595 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared May 1998. https://www.510kdatabase.net/k980704/ 1998-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k980704-safil-synthetic-absorbable-surgical-fda-510k.jpg K980704 - SAFIL SYNTHETIC ABSORBABLE SURGICAL SUTURE K980704 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared May 1998. https://www.510kdatabase.net/k981128/ 1998-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k981128-sofsilk-suture-fda-510k.jpg K981128 - SOFSILK SUTURE K981128 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared May 1998. https://www.510kdatabase.net/k981259/ 1998-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k981259-osteo-40mm-cannulated-screw-system-fda-510k.jpg K981259 - OSTEO 4.0MM CANNULATED SCREW SYSTEM K981259 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared May 1998. https://www.510kdatabase.net/k981372/ 1998-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k981372-synthes-30-mm-pc-fix-system-fda-510k.jpg K981372 - SYNTHES 3.0 MM PC-FIX SYSTEM K981372 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared May 1998. https://www.510kdatabase.net/k980694/ 1998-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k980694-ksea-plastic-trocars-fda-510k.jpg K980694 - KSEA PLASTIC TROCARS K980694 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared May 1998. https://www.510kdatabase.net/k981403/ 1998-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k981403-immage-immunochemistry-system-valproic-fda-510k.jpg K981403 - IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT K981403 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared May 1998. https://www.510kdatabase.net/k981185/ 1998-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k981185-glu-fda-510k.jpg K981185 - GLU K981185 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared May 1998. https://www.510kdatabase.net/k981189/ 1998-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k981189-uric-acid-fda-510k.jpg K981189 - URIC ACID K981189 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared May 1998. https://www.510kdatabase.net/k981305/ 1998-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k981305-olympus-serum-protein-multicalibrator-fda-510k.jpg K981305 - OLYMPUS SERUM PROTEIN MULTICALIBRATOR K981305 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus America, Inc.. Cleared May 1998. https://www.510kdatabase.net/k980646/ 1998-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k980646-il-synthesis-addition-of-bilirubin-as-fda-510k.jpg K980646 - IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE BLOOD SAMPLES K980646 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared May 1998. https://www.510kdatabase.net/k980428/ 1998-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k980428-biomet-biaxial-total-elbow-fda-510k.jpg K980428 - BIOMET BIAXIAL TOTAL ELBOW K980428 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared May 1998. https://www.510kdatabase.net/k980502/ 1998-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k980502-osteonics-total-elbow-system-fda-510k.jpg K980502 - OSTEONICS TOTAL ELBOW SYSTEM K980502 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared May 1998. https://www.510kdatabase.net/k980594/ 1998-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k980594-osteonics-fx-cablelok-grip-components-fda-510k.jpg K980594 - OSTEONICS FX-CABLELOK GRIP COMPONENTS K980594 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared May 1998. https://www.510kdatabase.net/k980703/ 1998-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k980703-premilene-nonabsorbable-polypropylene-fda-510k.jpg K980703 - PREMILENE NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE K980703 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared May 1998. https://www.510kdatabase.net/k974456/ 1998-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k974456-cmvgen-fda-510k.jpg K974456 - CMVGEN K974456 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared May 1998. https://www.510kdatabase.net/k974711/ 1998-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k974711-coamatic-plasminogen-fda-510k.jpg K974711 - COAMATIC PLASMINOGEN K974711 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared May 1998. https://www.510kdatabase.net/k974883/ 1998-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k974883-bactec-mgit-960-system-fda-510k.jpg K974883 - BACTEC MGIT 960 SYSTEM K974883 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared May 1998. https://www.510kdatabase.net/k980206/ 1998-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k980206-immulite-anti-tg-ab-fda-510k.jpg K980206 - IMMULITE ANTI-TG AB K980206 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared May 1998. https://www.510kdatabase.net/k980385/ 1998-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k980385-datascope-8fr-co-lumen-34-and-40cc-fda-510k.jpg K980385 - DATASCOPE 8FR. CO-LUMEN 34 AND 40CC INTRA-AORTIC BALLOON CATHETERS FOR OPTIONAL SHEATHLESS INSERTION WITH ACCESSORIES K980385 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared May 1998. https://www.510kdatabase.net/k980650/ 1998-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k980650-rep-cholesterol-profile-template-30-16-8-fda-510k.jpg K980650 - REP CHOLESTEROL PROFILE TEMPLATE-30, -16, -8 K980650 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared May 1998. https://www.510kdatabase.net/k980833/ 1998-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k980833-immulite-pyrilinks-d-model-numbers-fda-510k.jpg K980833 - IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5 K980833 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared May 1998. https://www.510kdatabase.net/k981192/ 1998-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k981192-mg-fda-510k.jpg K981192 - MG K981192 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared May 1998. https://www.510kdatabase.net/k981218/ 1998-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k981218-creatine-kinase-ck-fda-510k.jpg K981218 - CREATINE KINASE (CK) K981218 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared May 1998. https://www.510kdatabase.net/k981241/ 1998-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k981241-iron-fda-510k.jpg K981241 - IRON K981241 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared May 1998. https://www.510kdatabase.net/k981336/ 1998-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k981336-tbil-fda-510k.jpg K981336 - TBIL K981336 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared May 1998. https://www.510kdatabase.net/k981354/ 1998-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k981354-access-afp-reagents-on-the-access-fda-510k.jpg K981354 - ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211 K981354 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared May 1998. https://www.510kdatabase.net/k980364/ 1998-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k980364-howmedica-and-howmedica-leibinger-bone-fda-510k.jpg K980364 - HOWMEDICA AND HOWMEDICA LEIBINGER BONE SCREW WASHERS K980364 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Apr 1998. https://www.510kdatabase.net/k980774/ 1998-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k980774-osteonics-gap-ii-restoration-fda-510k.jpg K980774 - OSTEONICS GAP-II RESTORATION ACETABULAR SHELLS K980774 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Apr 1998. https://www.510kdatabase.net/k981060/ 1998-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k981060-abbott-axsym-3rd-generation-tsh-assay-fda-510k.jpg K981060 - ABBOTT AXSYM 3RD GENERATION TSH ASSAY K981060 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1998. https://www.510kdatabase.net/k981248/ 1998-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k981248-sigma-diagnostics-accuclot-control-i-fda-510k.jpg K981248 - SIGMA DIAGNOSTICS ACCUCLOT CONTROL I K981248 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Apr 1998. https://www.510kdatabase.net/k981254/ 1998-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k981254-sigma-diagnostics-accuclot-control-ii-fda-510k.jpg K981254 - SIGMA DIAGNOSTICS ACCUCLOT CONTROL II K981254 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Apr 1998. https://www.510kdatabase.net/k981255/ 1998-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k981255-sigma-diagnostics-accuclot-control-iii-fda-510k.jpg K981255 - SIGMA DIAGNOSTICS ACCUCLOT CONTROL III K981255 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Apr 1998. https://www.510kdatabase.net/k980944/ 1998-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k980944-synthes-schuhli-implant-system-fda-510k.jpg K980944 - SYNTHES SCHUHLI IMPLANT SYSTEM K980944 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Apr 1998. https://www.510kdatabase.net/k981098/ 1998-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k981098-stratus-cs-cardiac-troponin-i-testpak-fda-510k.jpg K981098 - STRATUS CS CARDIAC TROPONIN I TESTPAK K981098 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Apr 1998. https://www.510kdatabase.net/k981102/ 1998-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k981102-stratus-cs-myoglobin-myo-testpak-fda-510k.jpg K981102 - STRATUS CS MYOGLOBIN (MYO) TESTPAK K981102 is a FDA 510(k) cleared immunology medical device. Manufacturer: Dade Behring, Inc.. Cleared Apr 1998. https://www.510kdatabase.net/k972911/ 1998-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k972911-auto-sutureendostitch-ii-suture-applier-fda-510k.jpg K972911 - AUTO SUTURE*ENDOSTITCH* II** SUTURE APPLIER K972911 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Apr 1998. https://www.510kdatabase.net/k974840/ 1998-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k974840-abuscreen-online-ii-for-opiates-fda-510k.jpg K974840 - ABUSCREEN ONLINE II FOR OPIATES 300/2000, ABUSCREEN ONLINE OPIATES CALIBRATION PACK, ABUSCREEN ONLINE OPIATES CONTROL K974840 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Apr 1998. https://www.510kdatabase.net/k980322/ 1998-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k980322-accent-16-accent-22-fda-510k.jpg K980322 - ACCENT 16, ACCENT 22 K980322 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Apr 1998. https://www.510kdatabase.net/k980557/ 1998-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k980557-sonoline-elegra-diagnostic-ultrasound-fda-510k.jpg K980557 - SONOLINE ELEGRA DIAGNOSTIC ULTRASOUND SYSTEM WITH SUPERFICIAL MUSCULOSKELETAL IMAGING K980557 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 1998. https://www.510kdatabase.net/k980614/ 1998-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k980614-abbott-cell-dyn-3000-series-hematology-fda-510k.jpg K980614 - ABBOTT CELL-DYN 3000 SERIES HEMATOLOGY SYSTEMS K980614 is a FDA 510(k) cleared hematology medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1998. https://www.510kdatabase.net/k981222/ 1998-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k981222-direct-bilirubin-dbil-fda-510k.jpg K981222 - DIRECT BILIRUBIN (DBIL) K981222 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1998. https://www.510kdatabase.net/k981221/ 1998-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k981221-aspartate-aminotransferase-activated-fda-510k.jpg K981221 - ASPARTATE AMINOTRANSFERASE ACTIVATED ( AST ACTIVATED) K981221 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1998. https://www.510kdatabase.net/k981225/ 1998-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k981225-aspartate-aminotransferase-ast-fda-510k.jpg K981225 - ASPARTATE AMINOTRANSFERASE (AST) K981225 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1998. https://www.510kdatabase.net/k980795/ 1998-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k980795-urological-balloon-dilatation-catheter-fda-510k.jpg K980795 - UROLOGICAL BALLOON DILATATION CATHETER K980795 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Apr 1998. https://www.510kdatabase.net/k980851/ 1998-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k980851-galaxy-intravascular-ultrasound-system-fda-510k.jpg K980851 - GALAXY INTRAVASCULAR ULTRASOUND SYSTEM, MODEL I5028 K980851 is a FDA 510(k) cleared radiology medical device. Manufacturer: Boston Scientific Corp. Cleared Apr 1998. https://www.510kdatabase.net/k981318/ 1998-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k981318-dual-luer-lock-cap-fda-510k.jpg K981318 - DUAL LUER LOCK CAP K981318 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Apr 1998. https://www.510kdatabase.net/k974842/ 1998-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k974842-immulite-2000-3rd-generation-psa-fda-510k.jpg K974842 - IMMULITE 2000 3RD GENERATION PSA K974842 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Apr 1998. https://www.510kdatabase.net/k980465/ 1998-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k980465-olympus-tjf-140rjf-140r-evis-fda-510k.jpg K980465 - OLYMPUS TJF-140R/JF-140R EVIS DUODENOVIDEOSCOPES AND ACCESSORIES, OLYMPUS MAJ-311/MAJ-411 DISTAL COVERS K980465 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus America, Inc.. Cleared Apr 1998. https://www.510kdatabase.net/k980667/ 1998-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k980667-infinity-cholesterol-reagent-procedure-fda-510k.jpg K980667 - INFINITY CHOLESTEROL REAGENT (PROCEDURE NO. 401) K980667 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Apr 1998. https://www.510kdatabase.net/k980757/ 1998-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k980757-ilab-600-clinical-chemistry-system-fda-510k.jpg K980757 - ILAB 600 CLINICAL CHEMISTRY SYSTEM K980757 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Apr 1998. https://www.510kdatabase.net/k980853/ 1998-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k980853-cedia-dau-multi-drug-calibrators-fda-510k.jpg K980853 - CEDIA DAU MULTI-DRUG CALIBRATORS K980853 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Apr 1998. https://www.510kdatabase.net/k980875/ 1998-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k980875-il-test-protein-c-fda-510k.jpg K980875 - IL TEST PROTEIN C K980875 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Apr 1998. https://www.510kdatabase.net/k980199/ 1998-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k980199-synthes-15mm20mm-orthognathic-fda-510k.jpg K980199 - SYNTHES 1.5MM/2.0MM ORTHOGNATHIC MAXILLARY PLATES AND SCREWS K980199 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Apr 1998. https://www.510kdatabase.net/k972800/ 1998-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k972800-pta-balloon-catheter-fda-510k.jpg K972800 - PTA BALLOON CATHETER K972800 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Apr 1998. https://www.510kdatabase.net/k973775/ 1998-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k973775-harpoon-suture-anchors-fda-510k.jpg K973775 - HARPOON SUTURE ANCHORS K973775 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Apr 1998. https://www.510kdatabase.net/k980358/ 1998-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k980358-synthes-spine-posterior-fda-510k.jpg K980358 - SYNTHES SPINE POSTERIOR CERVICAL/THORACIC HOOK/ROD SYSTEM K980358 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Apr 1998. https://www.510kdatabase.net/k981038/ 1998-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k981038-coamatic-factor-viii-fda-510k.jpg K981038 - COAMATIC FACTOR VIII K981038 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Apr 1998. https://www.510kdatabase.net/k981097/ 1998-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k981097-stratus-cs-ckmb-calpak-fda-510k.jpg K981097 - STRATUS CS CKMB CALPAK K981097 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Apr 1998. https://www.510kdatabase.net/k981100/ 1998-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k981100-stratus-cs-trop-calpak-fda-510k.jpg K981100 - STRATUS CS TROP CALPAK K981100 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Apr 1998. https://www.510kdatabase.net/k980134/ 1998-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k980134-ksea-n2o-endoflator-fda-510k.jpg K980134 - KSEA N2O ENDOFLATOR K980134 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Apr 1998. https://www.510kdatabase.net/k981051/ 1998-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k981051-soft-tissue-patch-plus-dualmesh-plus-fda-510k.jpg K981051 - SOFT TISSUE PATCH PLUS, DUALMESH PLUS, MYCROMESH PLUS, DUALMESH PLUS WITH HOLES K981051 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Apr 1998. https://www.510kdatabase.net/k981101/ 1998-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k981101-stratus-cs-myo-calpak-fda-510k.jpg K981101 - STRATUS CS MYO CALPAK K981101 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Apr 1998. https://www.510kdatabase.net/k980368/ 1998-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k980368-depuy-motech-peak-3mm-fixation-rod-fda-510k.jpg K980368 - DEPUY MOTECH PEAK 3MM FIXATION ROD SYSTEM K980368 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Apr 1998. https://www.510kdatabase.net/k980370/ 1998-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k980370-biosymmetric-proximal-interphalangeal-fda-510k.jpg K980370 - BIOSYMMETRIC PROXIMAL INTERPHALANGEAL JOINT FIXATOR K980370 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Apr 1998. https://www.510kdatabase.net/k980447/ 1998-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k980447-depuy-motech-moss-miami-spinal-system-fda-510k.jpg K980447 - DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM K980447 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Apr 1998. https://www.510kdatabase.net/k980496/ 1998-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k980496-wright-medical-technology-rod-to-rod-fda-510k.jpg K980496 - WRIGHT MEDICAL TECHNOLOGY ROD-TO-ROD COUPLER K980496 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Apr 1998. https://www.510kdatabase.net/k980513/ 1998-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k980513-articuleze-femoral-heads-fda-510k.jpg K980513 - ARTICUL/EZE FEMORAL HEADS K980513 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Apr 1998. https://www.510kdatabase.net/k980543/ 1998-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k980543-denoptix-barrier-envelope-size-0-4-fda-510k.jpg K980543 - DENOPTIX BARRIER ENVELOPE (SIZE 0-4) K980543 is a FDA 510(k) cleared radiology medical device. Manufacturer: Dentsply Intl.. Cleared Apr 1998. https://www.510kdatabase.net/k980169/ 1998-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k980169-hispeed-lxi-hispeed-fxi-and-hispeed-fda-510k.jpg K980169 - HISPEED LX//I, HISPEED FX/I, AND HISPEED DX/I FAMILY OF SYSTEMS K980169 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Apr 1998. https://www.510kdatabase.net/k980176/ 1998-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k980176-hispeed-qxi-ct-scanner-system-fda-510k.jpg K980176 - HISPEED QX/I CT SCANNER SYSTEM K980176 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Apr 1998. https://www.510kdatabase.net/k970961/ 1998-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k970961-vaporization-electrodes-fda-510k.jpg K970961 - VAPORIZATION ELECTRODES K970961 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Apr 1998. https://www.510kdatabase.net/k980503/ 1998-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k980503-temporary-cardiac-pacing-wire-fda-510k.jpg K980503 - TEMPORARY CARDIAC PACING WIRE K980503 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ethicon, Inc.. Cleared Apr 1998. https://www.510kdatabase.net/k980081/ 1998-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k980081-s-rom-zirconia-ceramic-femoral-hip-head-fda-510k.jpg K980081 - S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD K980081 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Apr 1998. https://www.510kdatabase.net/k980871/ 1998-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k980871-lyphochek-whole-blood-control-fda-510k.jpg K980871 - LYPHOCHEK WHOLE BLOOD CONTROL K980871 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bio-Rad. Cleared Apr 1998. https://www.510kdatabase.net/k980286/ 1998-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k980286-ultima-acetabular-roof-reinforcement-fda-510k.jpg K980286 - ULTIMA ACETABULAR ROOF REINFORCEMENT RING K980286 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Apr 1998. https://www.510kdatabase.net/k980440/ 1998-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k980440-depuy-orthotech-phantom-sof-thread-fda-510k.jpg K980440 - DEPUY ORTHOTECH PHANTOM SOF-THREAD SOFT TISSUE INTERFERENCE SCREW K980440 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Apr 1998. https://www.510kdatabase.net/k980679/ 1998-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k980679-endobon-fda-510k.jpg K980679 - ENDOBON K980679 is a FDA 510(k) cleared dental medical device. Manufacturer: Biomet, Inc.. Cleared Apr 1998. https://www.510kdatabase.net/k980181/ 1998-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k980181-terumo-disposable-hypodermc-syringe-fda-510k.jpg K980181 - TERUMO DISPOSABLE HYPODERMC SYRINGE K980181 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terumo Medical Corp.. Cleared Apr 1998. https://www.510kdatabase.net/k980312/ 1998-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k980312-nova-lite-endomysial-fda-510k.jpg K980312 - NOVA LITE ENDOMYSIAL K980312 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Apr 1998. https://www.510kdatabase.net/k980499/ 1998-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k980499-il-test-antithrombin-fda-510k.jpg K980499 - IL TEST ANTITHROMBIN K980499 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Apr 1998. https://www.510kdatabase.net/k980755/ 1998-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k980755-b-d-e-ml-pen-fda-510k.jpg K980755 - B-D E ML PEN K980755 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1998. https://www.510kdatabase.net/k980155/ 1998-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k980155-endobutton-continuous-loop-fda-510k.jpg K980155 - ENDOBUTTON CONTINUOUS LOOP K980155 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Apr 1998. https://www.510kdatabase.net/k980367/ 1998-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k980367-aeroset-system-fda-510k.jpg K980367 - AEROSET SYSTEM K980367 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1998. https://www.510kdatabase.net/k980114/ 1998-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k980114-magnetic-resonance-diagnostic-system-fda-510k.jpg K980114 - MAGNETIC RESONANCE DIAGNOSTIC SYSTEM K980114 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Mar 1998. https://www.510kdatabase.net/k980124/ 1998-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k980124-sofsilk-suture-fda-510k.jpg K980124 - SOFSILK SUTURE K980124 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Mar 1998. https://www.510kdatabase.net/k980240/ 1998-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k980240-elecsys-ca-125ii-on-the-elecsys-1010-fda-510k.jpg K980240 - ELECSYS CA 125II ON THE ELECSYS 1010 K980240 is a FDA 510(k) cleared immunology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Mar 1998. https://www.510kdatabase.net/k980230/ 1998-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k980230-quanta-lite-b2-gpi-screen-fda-510k.jpg K980230 - QUANTA LITE B2 GPI SCREEN K980230 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Mar 1998. https://www.510kdatabase.net/k974788/ 1998-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k974788-cretm-balloon-dilatation-catheter-fda-510k.jpg K974788 - CRE(TM) BALLOON DILATATION CATHETER K974788 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Mar 1998. https://www.510kdatabase.net/k980666/ 1998-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k980666-infinity-ast-reagent-procedure-no-51-fda-510k.jpg K980666 - INFINITY AST REAGENT (PROCEDURE NO. 51) K980666 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Mar 1998. https://www.510kdatabase.net/k980242/ 1998-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k980242-il-test-heparin-fda-510k.jpg K980242 - IL TEST HEPARIN K980242 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Mar 1998. https://www.510kdatabase.net/k972162/ 1998-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k972162-elecsys-ca-125-ii-fda-510k.jpg K972162 - ELECSYS CA 125 II K972162 is a FDA 510(k) cleared immunology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Mar 1998. https://www.510kdatabase.net/k974740/ 1998-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k974740-depuy-tri-lock-hip-stem-fda-510k.jpg K974740 - DEPUY TRI-LOCK HIP STEM K974740 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Mar 1998. https://www.510kdatabase.net/k974746/ 1998-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k974746-m1765a-ecg-manager-fda-510k.jpg K974746 - M1765A ECG MANAGER K974746 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Mar 1998. https://www.510kdatabase.net/k974908/ 1998-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k974908-synthes-sterile-27-mm-reconstruction-fda-510k.jpg K974908 - SYNTHES STERILE 2.7 MM RECONSTRUCTION PLATES K974908 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Mar 1998. https://www.510kdatabase.net/k980173/ 1998-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k980173-access-total-bhcg-reagents-on-the-fda-510k.jpg K980173 - ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER K980173 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Mar 1998. https://www.510kdatabase.net/k974778/ 1998-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k974778-abbott-gemstar-iv-infusion-pump-fda-510k.jpg K974778 - ABBOTT GEMSTAR IV INFUSION PUMP K974778 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1998. https://www.510kdatabase.net/k980118/ 1998-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k980118-kodak-digital-science-oncology-image-fda-510k.jpg K980118 - KODAK DIGITAL SCIENCE ONCOLOGY IMAGE MANAGER K980118 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Mar 1998. https://www.510kdatabase.net/k974206/ 1998-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k974206-synthes-cranial-spring-clip-csc-fda-510k.jpg K974206 - SYNTHES CRANIAL SPRING CLIP (CSC) K974206 is a FDA 510(k) cleared neurology medical device. Manufacturer: Synthes (Usa). Cleared Mar 1998. https://www.510kdatabase.net/k974807/ 1998-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k974807-osteo-austin-moore-endoprosthesis-system-fda-510k.jpg K974807 - OSTEO AUSTIN MOORE ENDOPROSTHESIS SYSTEM K974807 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Mar 1998. https://www.510kdatabase.net/k973405/ 1998-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k973405-yeung-endoscopic-spine-system-fda-510k.jpg K973405 - YEUNG ENDOSCOPIC SPINE SYSTEM K973405 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Mar 1998. https://www.510kdatabase.net/k974640/ 1998-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k974640-coaxial-dilator-set-fda-510k.jpg K974640 - COAXIAL DILATOR SET K974640 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Mar 1998. https://www.510kdatabase.net/k974706/ 1998-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k974706-aesculap-abc-cervical-plating-system-fda-510k.jpg K974706 - AESCULAP ABC CERVICAL PLATING SYSTEM K974706 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aesculap, Inc.. Cleared Mar 1998. https://www.510kdatabase.net/k974903/ 1998-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k974903-gas-module-ii-model-0998-00-0143-fda-510k.jpg K974903 - GAS MODULE II, MODEL 0998-00-0143 K974903 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Datascope Corp.. Cleared Mar 1998. https://www.510kdatabase.net/k970653/ 1998-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k970653-cahp-high-performance-cellulose-fda-510k.jpg K970653 - CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER) K970653 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 1998. https://www.510kdatabase.net/k970662/ 1998-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k970662-ca-cellulose-acetate-hollow-fiber-fda-510k.jpg K970662 - CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-170/CA-210) K970662 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 1998. https://www.510kdatabase.net/k974734/ 1998-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k974734-aurora-titanium-spinal-rod-system-fda-510k.jpg K974734 - AURORA TITANIUM SPINAL ROD SYSTEM K974734 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Mar 1998. https://www.510kdatabase.net/k974781/ 1998-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k974781-depuy-ace-aimr-titanium-supracondylar-fda-510k.jpg K974781 - DEPUY ACE AIM(R) TITANIUM SUPRACONDYLAR NAIL K974781 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Mar 1998. https://www.510kdatabase.net/k974844/ 1998-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k974844-outlook-system-enhancement-package-fda-510k.jpg K974844 - OUTLOOK SYSTEM ENHANCEMENT PACKAGE K974844 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Mar 1998. https://www.510kdatabase.net/k980092/ 1998-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k980092-smith-nephew-dyonics-intelijet-fda-510k.jpg K980092 - SMITH & NEPHEW DYONICS INTELIJET REUSABLE CANNULAS K980092 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Mar 1998. https://www.510kdatabase.net/k974558/ 1998-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k974558-salvageonocology-hip-and-total-femur-fda-510k.jpg K974558 - SALVAGE/ONOCOLOGY HIP AND TOTAL FEMUR SYSTEM K974558 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Mar 1998. https://www.510kdatabase.net/k971522/ 1998-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k971522-abbott-testpack-plus-strep-a-with-on-fda-510k.jpg K971522 - ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II K971522 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1998. https://www.510kdatabase.net/k973523/ 1998-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k973523-accustat-h-pylori-one-step-test-fda-510k.jpg K973523 - ACCUSTAT H. PYLORI ONE STEP TEST K973523 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Mar 1998. https://www.510kdatabase.net/k974555/ 1998-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k974555-synthes-20-mm-locking-plate-system-20-fda-510k.jpg K974555 - SYNTHES 2.0 MM LOCKING PLATE SYSTEM (2.0 LPS) K974555 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Mar 1998. https://www.510kdatabase.net/k980414/ 1998-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k980414-vacutainer-brand-safety-lok-blood-fda-510k.jpg K980414 - VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET MODEL MULTIPLE, VACUTAINER BRAND BLOOD COLLECTION SET K980414 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1998. https://www.510kdatabase.net/k973357/ 1998-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k973357-coonradmorrey-total-elbow-new-hinge-pin-fda-510k.jpg K973357 - COONRAD/MORREY TOTAL ELBOW, NEW HINGE PIN K973357 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Mar 1998. https://www.510kdatabase.net/k973909/ 1998-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k973909-ksea-endotip-system-fda-510k.jpg K973909 - KSEA ENDOTIP SYSTEM K973909 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Feb 1998. https://www.510kdatabase.net/k974067/ 1998-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k974067-fountain-infusion-catheter-and-fda-510k.jpg K974067 - FOUNTAIN INFUSION CATHETER AND OCCLUDING GUIDE WIRE K974067 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Feb 1998. https://www.510kdatabase.net/k974556/ 1998-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k974556-osteonics-scorpio-posterior-cruciate-fda-510k.jpg K974556 - OSTEONICS SCORPIO POSTERIOR CRUCIATE RETAINING TOTAL KNEE SYSTEM K974556 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Feb 1998. https://www.510kdatabase.net/k974492/ 1998-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k974492-siemens-sc6000sc6000p-bedside-fda-510k.jpg K974492 - SIEMENS SC6000/SC6000P BEDSIDE MONITORING SYSTEM ENHANCED WITH ST SEGMENT ANALYSIS K974492 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 1998. https://www.510kdatabase.net/k980556/ 1998-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k980556-liquichek-cardiac-markers-control-lt-fda-510k.jpg K980556 - LIQUICHEK CARDIAC MARKERS CONTROL LT K980556 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Feb 1998. https://www.510kdatabase.net/k974554/ 1998-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k974554-synthes-resorbable-fixation-system-fda-510k.jpg K974554 - SYNTHES RESORBABLE FIXATION SYSTEM K974554 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Feb 1998. https://www.510kdatabase.net/k980332/ 1998-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k980332-mta-material-fda-510k.jpg K980332 - MTA MATERIAL K980332 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Feb 1998. https://www.510kdatabase.net/k974816/ 1998-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k974816-accessr-psa-reagents-on-the-accessr-fda-510k.jpg K974816 - ACCESS(R) PSA REAGENTS ON THE ACCESS(R) IMMUNOASSAY ANALYZER 33220, 33225, 33229 K974816 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Feb 1998. https://www.510kdatabase.net/k973962/ 1998-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k973962-bard-9fr-30cc-rediguard-and-taperseal-fda-510k.jpg K973962 - BARD 9FR., 30CC REDIGUARD AND TAPERSEAL BALLOONS K973962 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Feb 1998. https://www.510kdatabase.net/k974420/ 1998-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k974420-m1730b-tracemaster-ecg-system-m1766b-fda-510k.jpg K974420 - M1730B TRACEMASTER ECG SYSTEM, M1766B LOCAL EDIT STATION, M1798B REMOTE EDIT STATION K974420 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Feb 1998. https://www.510kdatabase.net/k974435/ 1998-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k974435-michelson-anterior-cervical-plate-system-fda-510k.jpg K974435 - MICHELSON ANTERIOR CERVICAL PLATE SYSTEM K974435 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Feb 1998. https://www.510kdatabase.net/k974537/ 1998-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k974537-synthes-cannulated-angle-blade-plate-fda-510k.jpg K974537 - SYNTHES CANNULATED ANGLE BLADE PLATE (CABP) SYSTEM K974537 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Feb 1998. https://www.510kdatabase.net/k974573/ 1998-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k974573-depuy-motech-moss-miami-spinal-system-fda-510k.jpg K974573 - DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM K974573 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Feb 1998. https://www.510kdatabase.net/k974564/ 1998-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k974564-immage-immunochemistry-system-alpha-2-fda-510k.jpg K974564 - IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-2-MACROGLOBULIN REAGENT K974564 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Feb 1998. https://www.510kdatabase.net/k980369/ 1998-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k980369-tbq-rtu-fda-510k.jpg K980369 - T.B.Q. RTU K980369 is a FDA 510(k) cleared general hospital medical device. Manufacturer: STERIS Corporation. Cleared Feb 1998. https://www.510kdatabase.net/k974299/ 1998-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k974299-panacryl-fda-510k.jpg K974299 - PANACRYL K974299 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Feb 1998. https://www.510kdatabase.net/k974367/ 1998-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k974367-advantx-lcn-advantx-lclp-fda-510k.jpg K974367 - ADVANTX LCN, ADVANTX LCLP K974367 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Feb 1998. https://www.510kdatabase.net/k974779/ 1998-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k974779-abbott-alcyontm-300-without-ise-module-fda-510k.jpg K974779 - ABBOTT ALCYON(TM) 300 (WITHOUT ISE MODULE) AND 300I (WITH ISE MODULE) ANALYZER K974779 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Feb 1998. https://www.510kdatabase.net/k974651/ 1998-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k974651-abbott-axsym-system-fda-510k.jpg K974651 - ABBOTT AXSYM SYSTEM K974651 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Feb 1998. https://www.510kdatabase.net/k971206/ 1998-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k971206-meridian-st-femoral-stem-and-vitalock-fda-510k.jpg K971206 - MERIDIAN ST FEMORAL STEM AND VITALOCK SOLID BACK SHELL W/ PERI-APATITE COATING K971206 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Feb 1998. https://www.510kdatabase.net/k972771/ 1998-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k972771-phased-array-transducer-pvf-375dt-fda-510k.jpg K972771 - PHASED ARRAY TRANSDUCER - - PVF -375DT K972771 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Feb 1998. https://www.510kdatabase.net/k974247/ 1998-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k974247-40-cc-grande-fda-510k.jpg K974247 - 40 CC GRANDE K974247 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Feb 1998. https://www.510kdatabase.net/k974397/ 1998-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k974397-sterile-saline-for-catheter-care-fda-510k.jpg K974397 - STERILE SALINE FOR CATHETER CARE K974397 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Feb 1998. https://www.510kdatabase.net/k973221/ 1998-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k973221-composite-168-restorative-system-fda-510k.jpg K973221 - COMPOSITE 168 RESTORATIVE SYSTEM K973221 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Feb 1998. https://www.510kdatabase.net/k973350/ 1998-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k973350-bio-rad-microplate-17-fda-510k.jpg K973350 - BIO-RAD MICROPLATE 17-HYDROXYPROGESTERONE TEST K973350 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Feb 1998. https://www.510kdatabase.net/k974541/ 1998-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k974541-modified-ureteral-indwelling-fda-510k.jpg K974541 - MODIFIED URETERAL INDWELLING CATHETER/STENT K974541 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Feb 1998. https://www.510kdatabase.net/k972906/ 1998-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k972906-medtronic-twist-lock-anchor-partnumber-fda-510k.jpg K972906 - MEDTRONIC TWIST LOCK ANCHOR (PARTNUMBER 103953/3550TLA) K972906 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Feb 1998. https://www.510kdatabase.net/k974331/ 1998-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k974331-uni-rom-total-hip-system-femoral-stem-fda-510k.jpg K974331 - UNI-ROM TOTAL HIP SYSTEM FEMORAL STEM K974331 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Feb 1998. https://www.510kdatabase.net/k974448/ 1998-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k974448-cordis-brite-tip-catheter-sheath-fda-510k.jpg K974448 - CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM K974448 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Feb 1998. https://www.510kdatabase.net/k974530/ 1998-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k974530-duffusion-weighted-mr-imaging-package-fda-510k.jpg K974530 - DUFFUSION-WEIGHTED MR IMAGING PACKAGE K974530 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Feb 1998. https://www.510kdatabase.net/k972990/ 1998-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k972990-magnetic-resonance-diagnostic-system-fda-510k.jpg K972990 - MAGNETIC RESONANCE DIAGNOSTIC SYSTEM K972990 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Feb 1998. https://www.510kdatabase.net/k973235/ 1998-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k973235-dyract-ap-restorative-fda-510k.jpg K973235 - DYRACT AP RESTORATIVE K973235 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Feb 1998. https://www.510kdatabase.net/k974213/ 1998-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k974213-aurora-titanium-spinal-rod-system-fda-510k.jpg K974213 - AURORA TITANIUM SPINAL ROD SYSTEM K974213 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Feb 1998. https://www.510kdatabase.net/k974390/ 1998-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k974390-gluma-one-bond-fda-510k.jpg K974390 - GLUMA ONE BOND K974390 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Feb 1998. https://www.510kdatabase.net/k971756/ 1998-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k971756-medtronic-model-3998-lead-fda-510k.jpg K971756 - MEDTRONIC MODEL 3998 LEAD K971756 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Feb 1998. https://www.510kdatabase.net/k973516/ 1998-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k973516-capiox-hemoconcentrator-fda-510k.jpg K973516 - CAPIOX HEMOCONCENTRATOR K973516 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Terumo Medical Corp.. Cleared Jan 1998. https://www.510kdatabase.net/k974136/ 1998-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k974136-craniofacial-anchors-fda-510k.jpg K974136 - CRANIOFACIAL ANCHORS K974136 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jan 1998. https://www.510kdatabase.net/k974309/ 1998-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k974309-lactosorb-panels-fda-510k.jpg K974309 - LACTOSORB PANELS K974309 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jan 1998. https://www.510kdatabase.net/k974328/ 1998-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k974328-advance-total-knee-system-fda-510k.jpg K974328 - ADVANCE TOTAL KNEE SYSTEM K974328 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jan 1998. https://www.510kdatabase.net/k974825/ 1998-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k974825-boehringer-mannheim-cfas-hdlldl-c-plus-fda-510k.jpg K974825 - BOEHRINGER MANNHEIM C.F.A.S. - HDL/LDL-C-PLUS K974825 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jan 1998. https://www.510kdatabase.net/k974098/ 1998-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k974098-pubouurethral-sling-fda-510k.jpg K974098 - PUBOUURETHRAL SLING K974098 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ethicon, Inc.. Cleared Jan 1998. https://www.510kdatabase.net/k973875/ 1998-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k973875-rinoflow-micronized-ent-wash-system-fda-510k.jpg K973875 - RINOFLOW MICRONIZED E.N.T. WASH SYSTEM K973875 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Respironics, Inc.. Cleared Jan 1998. https://www.510kdatabase.net/k974733/ 1998-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k974733-boehringer-mannheim-direct-ldl-fda-510k.jpg K974733 - BOEHRINGER MANNHEIM DIRECT LDL - CHOLESTEROL K974733 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jan 1998. https://www.510kdatabase.net/k974006/ 1998-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k974006-becton-dickinson-twinpak-fda-510k.jpg K974006 - BECTON DICKINSON TWINPAK K974006 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jan 1998. https://www.510kdatabase.net/k974044/ 1998-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k974044-global-total-shoulder-eccentric-fda-510k.jpg K974044 - GLOBAL TOTAL SHOULDER ECCENTRIC HUMERAL HEAD K974044 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: DePuy Orthopaedics, Inc.. Cleared Jan 1998. https://www.510kdatabase.net/k974155/ 1998-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k974155-bmr-4500-filtered-venous-reservoir-and-fda-510k.jpg K974155 - BMR 4500 FILTERED VENOUS RESERVOIR AND BMR -4500 GOLD FILTERED VENOUS RESERVOIR WITH DURAFLO TREATMENT K974155 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jan 1998. https://www.510kdatabase.net/k974826/ 1998-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k974826-bm-precipathr-hdlldl-c-control-fda-510k.jpg K974826 - BM PRECIPATH(R) HDL/LDL-C CONTROL K974826 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jan 1998. https://www.510kdatabase.net/k972643/ 1998-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k972643-depuy-amk-3-peg-patella-fda-510k.jpg K972643 - DEPUY AMK 3 PEG PATELLA K972643 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jan 1998. https://www.510kdatabase.net/k973788/ 1998-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k973788-microvasive-lipthotripsy-probes-fda-510k.jpg K973788 - MICROVASIVE LIPTHOTRIPSY PROBES K973788 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Jan 1998. https://www.510kdatabase.net/k974107/ 1998-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k974107-kodak-digital-science-quality-control-fda-510k.jpg K974107 - KODAK DIGITAL SCIENCE QUALITY CONTROL WORKSTATION (QCW) K974107 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Jan 1998. https://www.510kdatabase.net/k974086/ 1998-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k974086-kodak-digital-science-cardiac-viewer-fda-510k.jpg K974086 - KODAK DIGITAL SCIENCE CARDIAC VIEWER K974086 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Jan 1998. https://www.510kdatabase.net/k974567/ 1998-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k974567-hewlett-packard-m2605a-viridia-wave-fda-510k.jpg K974567 - HEWLETT-PACKARD M2605A VIRIDIA WAVE VIEWER K974567 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Jan 1998. https://www.510kdatabase.net/k972242/ 1998-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k972242-reveal-insertable-loop-recorder-ilr-fda-510k.jpg K972242 - REVEAL INSERTABLE LOOP RECORDER (ILR) SYSTEM K972242 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jan 1998. https://www.510kdatabase.net/k972332/ 1998-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k972332-aesculap-craniofix-titanium-clamp-system-fda-510k.jpg K972332 - AESCULAP CRANIOFIX TITANIUM CLAMP SYSTEM K972332 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Jan 1998. https://www.510kdatabase.net/k972967/ 1998-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k972967-osteonics-scorpio-total-knee-universal-fda-510k.jpg K972967 - OSTEONICS SCORPIO TOTAL KNEE UNIVERSAL DOME PATELLAR COMPONENT K972967 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Jan 1998. https://www.510kdatabase.net/k973918/ 1998-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k973918-nihon-kohden-bsm-1101-and-bsm-1102-fda-510k.jpg K973918 - NIHON KOHDEN BSM-1101 AND BSM-1102 PATIENT MONITOR AND ACCESSORIES K973918 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Jan 1998. https://www.510kdatabase.net/k971116/ 1998-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k971116-sonos-5500-imaging-system-fda-510k.jpg K971116 - SONOS 5500 IMAGING SYSTEM K971116 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Jan 1998. https://www.510kdatabase.net/k974434/ 1998-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k974434-osteonics-series-7000-total-knee-fda-510k.jpg K974434 - OSTEONICS SERIES 7000 TOTAL KNEE ANTERIOR FEMORAL BLOCKS K974434 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Jan 1998. https://www.510kdatabase.net/k974592/ 1998-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k974592-interceptre-laparoscopic-instruments-fda-510k.jpg K974592 - INTERCEPTRE LAPAROSCOPIC INSTRUMENTS K974592 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jan 1998. https://www.510kdatabase.net/k970663/ 1998-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k970663-ct-celluloser-triacetate-hollow-fiber-fda-510k.jpg K970663 - CT CELLULOSER TRIACETATE HOLLOW FIBER DIALYZER (CT-110G/CT-190G) K970663 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jan 1998. https://www.510kdatabase.net/k972638/ 1998-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k972638-tina-quant-prealbumin-fda-510k.jpg K972638 - TINA-QUANT PREALBUMIN K972638 is a FDA 510(k) cleared immunology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jan 1998. https://www.510kdatabase.net/k972639/ 1998-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k972639-tina-quant-haptoglobin-fda-510k.jpg K972639 - TINA-QUANT HAPTOGLOBIN K972639 is a FDA 510(k) cleared immunology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jan 1998. https://www.510kdatabase.net/k972640/ 1998-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k972640-tina-quant-alpha-particle-1-fda-510k.jpg K972640 - TINA-QUANT ALPHA PARTICLE-1-ANTITRYPSIN ASSAY K972640 is a FDA 510(k) cleared immunology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jan 1998. https://www.510kdatabase.net/k974088/ 1998-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k974088-codman-intracranial-bolt-fda-510k.jpg K974088 - CODMAN INTRACRANIAL BOLT K974088 is a FDA 510(k) cleared neurology medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jan 1998. https://www.510kdatabase.net/k974569/ 1998-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k974569-coaguchek-system-coaguchek-system-for-fda-510k.jpg K974569 - COAGUCHEK SYSTEM, COAGUCHEK SYSTEM FOR PROTHROMBIN TIME SELF TESTING K974569 is a FDA 510(k) cleared hematology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jan 1998. https://www.510kdatabase.net/k974145/ 1998-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k974145-v3-valve-fda-510k.jpg K974145 - V3 VALVE K974145 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Jan 1998. https://www.510kdatabase.net/k974189/ 1998-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k974189-elecsys-psa-on-elecsys-1010-fda-510k.jpg K974189 - ELECSYS PSA (ON ELECSYS 1010) K974189 is a FDA 510(k) cleared immunology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jan 1998. https://www.510kdatabase.net/k974609/ 1998-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k974609-rep-cholesterol-profile-control-ii-fda-510k.jpg K974609 - REP CHOLESTEROL PROFILE CONTROL-II K974609 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Jan 1998. https://www.510kdatabase.net/k973845/ 1998-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k973845-cordis-hydronol-steerable-guidewire-fda-510k.jpg K973845 - CORDIS HYDRONOL STEERABLE GUIDEWIRE K973845 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Jan 1998. https://www.510kdatabase.net/k974140/ 1998-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k974140-adhesive-hybrid-ionomer-cement-fda-510k.jpg K974140 - ADHESIVE HYBRID IONOMER CEMENT K974140 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jan 1998. https://www.510kdatabase.net/k971304/ 1998-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k971304-quanta-lite-rebella-igg-fda-510k.jpg K971304 - QUANTA LITE REBELLA IGG K971304 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Jan 1998. https://www.510kdatabase.net/k973040/ 1998-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k973040-spife-ife-6-fda-510k.jpg K973040 - SPIFE IFE-6 K973040 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Jan 1998. https://www.510kdatabase.net/k973799/ 1998-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k973799-cardiac-tagging-techniquesmagnetom-fda-510k.jpg K973799 - CARDIAC TAGGING TECHNIQUES/MAGNETOM VISION AND MAGNETOM IMPACT K973799 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 1998. https://www.510kdatabase.net/k974634/ 1998-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k974634-immulite-free-t3-fda-510k.jpg K974634 - IMMULITE FREE T3 K974634 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jan 1998. https://www.510kdatabase.net/k973736/ 1997-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k973736-aesculap-hilan-motor-system-fda-510k.jpg K973736 - AESCULAP HILAN MOTOR SYSTEM K973736 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aesculap, Inc.. Cleared Dec 1997. https://www.510kdatabase.net/k973774/ 1997-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k973774-codman-hakim-micro-precision-valve-fda-510k.jpg K973774 - CODMAN HAKIM MICRO PRECISION VALVE K973774 is a FDA 510(k) cleared neurology medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Dec 1997. https://www.510kdatabase.net/k973714/ 1997-12-24 monthly 0.5 https://www.510kdatabase.net/og-image/k973714-versys-hip-system-beaded-hip-prosthesis-fda-510k.jpg K973714 - VERSYS HIP SYSTEM BEADED HIP PROSTHESIS K973714 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Dec 1997. https://www.510kdatabase.net/k974110/ 1997-12-24 monthly 0.5 https://www.510kdatabase.net/og-image/k974110-immage-immunochemistry-system-fda-510k.jpg K974110 - IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT K974110 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Dec 1997. https://www.510kdatabase.net/k970901/ 1997-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k970901-ge-logiq-500-diagnostic-ultrasound-fda-510k.jpg K970901 - GE LOGIQ 500 DIAGNOSTIC ULTRASOUND SYSTEM K970901 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Dec 1997. https://www.510kdatabase.net/k973908/ 1997-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k973908-auklet-ct-scanner-tsx-003a-fda-510k.jpg K973908 - AUKLET CT SCANNER, TSX-003A K973908 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Dec 1997. https://www.510kdatabase.net/k962985/ 1997-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k962985-ksea-ccl-vaginal-extractor-and-fda-510k.jpg K962985 - KSEA C.C.L. VAGINAL EXTRACTOR AND ACCESSORIES K962985 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Dec 1997. https://www.510kdatabase.net/k970708/ 1997-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k970708-clirans-t-series-hollow-fiber-dialyzers-fda-510k.jpg K970708 - CLIRANS T-SERIES HOLLOW FIBER DIALYZERS K970708 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Terumo Medical Corp.. Cleared Dec 1997. https://www.510kdatabase.net/k971086/ 1997-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k971086-radial-and-femoral-artery-catheter-fda-510k.jpg K971086 - RADIAL AND FEMORAL ARTERY CATHETER K971086 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Dec 1997. https://www.510kdatabase.net/k973708/ 1997-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k973708-tomcat-guide-wire-extender-wire-guide-fda-510k.jpg K973708 - TOMCAT GUIDE WIRE, EXTENDER WIRE, GUIDE WIRE EXTENSION TOOL K973708 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Dec 1997. https://www.510kdatabase.net/k974021/ 1997-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k974021-signal-pregnancy-test-kit-fda-510k.jpg K974021 - SIGNAL PREGNANCY TEST KIT K974021 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sa Scientific, Inc.. Cleared Dec 1997. https://www.510kdatabase.net/k974154/ 1997-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k974154-choice-accu-test-pregnancy-test-kit-fda-510k.jpg K974154 - CHOICE ACCU-TEST PREGNANCY TEST KIT K974154 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sa Scientific, Inc.. Cleared Dec 1997. https://www.510kdatabase.net/k973284/ 1997-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k973284-cobas-integra-hdl-cholesterol-direct-fda-510k.jpg K973284 - COBAS INTEGRA HDL-CHOLESTEROL DIRECT K973284 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Dec 1997. https://www.510kdatabase.net/k973594/ 1997-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k973594-gore-resolut-xt-regenerative-material-fda-510k.jpg K973594 - GORE RESOLUT XT REGENERATIVE MATERIAL K973594 is a FDA 510(k) cleared dental medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Dec 1997. https://www.510kdatabase.net/k973648/ 1997-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k973648-mini-forceps-with-hf-35mm-fda-510k.jpg K973648 - MINI FORCEPS WITH HF, 3.5MM K973648 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Dec 1997. https://www.510kdatabase.net/k973961/ 1997-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k973961-3m-dent-system-ii-plus-fda-510k.jpg K973961 - 3M DENT SYSTEM II PLUS K973961 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Dec 1997. https://www.510kdatabase.net/k974035/ 1997-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k974035-century-alloy-fda-510k.jpg K974035 - CENTURY ALLOY K974035 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Dec 1997. https://www.510kdatabase.net/k974125/ 1997-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k974125-il-test-amylase-fda-510k.jpg K974125 - IL TEST AMYLASE K974125 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Dec 1997. https://www.510kdatabase.net/k974337/ 1997-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k974337-il-test-urea-nitrogen-fda-510k.jpg K974337 - IL TEST UREA NITROGEN K974337 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Dec 1997. https://www.510kdatabase.net/k974421/ 1997-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k974421-elecsys-ck-mb-stat-fda-510k.jpg K974421 - ELECSYS CK-MB STAT K974421 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Dec 1997. https://www.510kdatabase.net/k974452/ 1997-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k974452-vigil-lipid-control-fda-510k.jpg K974452 - VIGIL LIPID CONTROL K974452 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Dec 1997. https://www.510kdatabase.net/k973818/ 1997-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k973818-t-rex-biopsy-forceps-fda-510k.jpg K973818 - T-REX BIOPSY FORCEPS K973818 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Dec 1997. https://www.510kdatabase.net/k973008/ 1997-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k973008-courier-st-balloon-dilatation-catheter-fda-510k.jpg K973008 - COURIER ST BALLOON DILATATION CATHETER K973008 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Dec 1997. https://www.510kdatabase.net/k973662/ 1997-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k973662-accu-chekrcomplete-systemmeter-accu-fda-510k.jpg K973662 - ACCU-CHEK(R)COMPLETE SYSTEM/METER & ACCU-CHEK ADVANTAGE TEST STRIPS/ACCU-CHEK ADVANTAGE H TEST STRIPS K973662 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Dec 1997. https://www.510kdatabase.net/k973932/ 1997-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k973932-beckman-calibrator-2-cal2-fda-510k.jpg K973932 - BECKMAN CALIBRATOR 2 (CAL2) K973932 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Dec 1997. https://www.510kdatabase.net/k973524/ 1997-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k973524-advance-modular-tibial-component-fda-510k.jpg K973524 - ADVANCE MODULAR TIBIAL COMPONENT K973524 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Dec 1997. https://www.510kdatabase.net/k973737/ 1997-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k973737-mini-trocar-sleeve-and-trocars-35-mm-fda-510k.jpg K973737 - MINI TROCAR SLEEVE AND TROCARS 3.5 MM, MICRO TROCAR SLEEVE AND TROCARS 2 MM, DILATATION SLEEVE AND GUIDE ROD 2 MM TO 3.M K973737 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Dec 1997. https://www.510kdatabase.net/k972744/ 1997-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k972744-courier-st-balloon-dilatation-catheter-fda-510k.jpg K972744 - COURIER ST BALLOON DILATATION CATHETER K972744 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Dec 1997. https://www.510kdatabase.net/k972887/ 1997-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k972887-medline-premium-leg-bag-medline-fabric-fda-510k.jpg K972887 - MEDLINE PREMIUM LEG BAG, MEDLINE FABRIC BAC LEG BAG, MEDLINE URINARY LEG BAG K972887 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medline Industries, Inc.. Cleared Dec 1997. https://www.510kdatabase.net/k972979/ 1997-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k972979-smith-nephew-images-cystourethroscopes-fda-510k.jpg K972979 - SMITH & NEPHEW IMAGES CYSTOURETHROSCOPES AND ACCESSORIES, SMITH & NEPHEW SEMI0RIGID AND FLEXIBLE MANUAL SURGICAL INSTRUM K972979 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Dec 1997. https://www.510kdatabase.net/k973781/ 1997-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k973781-aquasil-easy-mix-putty-impression-fda-510k.jpg K973781 - AQUASIL EASY MIX PUTTY IMPRESSION MATERIAL K973781 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Dec 1997. https://www.510kdatabase.net/k970851/ 1997-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k970851-lyoplant-dura-substitutevarious-fda-510k.jpg K970851 - LYOPLANT DURA SUBSTITUTE(VARIOUS) K970851 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Dec 1997. https://www.510kdatabase.net/k973438/ 1997-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k973438-osteo-bos-system-product-line-extension-fda-510k.jpg K973438 - OSTEO BOS SYSTEM PRODUCT LINE EXTENSION K973438 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Dec 1997. https://www.510kdatabase.net/k973406/ 1997-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k973406-osteonics-series-7000-total-knee-fda-510k.jpg K973406 - OSTEONICS SERIES 7000 TOTAL KNEE AUGMENTED FEMORAL COMPONENT K973406 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Dec 1997. https://www.510kdatabase.net/k974383/ 1997-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k974383-elecsys-calcheck-vitamin-b12-fda-510k.jpg K974383 - ELECSYS CALCHECK VITAMIN B12 K974383 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Dec 1997. https://www.510kdatabase.net/k974384/ 1997-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k974384-elecsys-calcheck-folate-fda-510k.jpg K974384 - ELECSYS CALCHECK FOLATE K974384 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Dec 1997. https://www.510kdatabase.net/k973384/ 1997-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k973384-ethicon-non-stick-bipolar-forceps-fda-510k.jpg K973384 - ETHICON NON-STICK BIPOLAR FORCEPS K973384 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Dec 1997. https://www.510kdatabase.net/k973630/ 1997-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k973630-cp-breast-array-coilmagnetom-fda-510k.jpg K973630 - CP BREAST ARRAY COIL/MAGNETOM HARMONY/SYMPHONY SYSTEM K973630 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Dec 1997. https://www.510kdatabase.net/k973826/ 1997-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k973826-sphincterotome-fda-510k.jpg K973826 - SPHINCTEROTOME K973826 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Dec 1997. https://www.510kdatabase.net/k971824/ 1997-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k971824-reach-femoral-hip-component-fda-510k.jpg K971824 - REACH FEMORAL HIP COMPONENT K971824 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Dec 1997. https://www.510kdatabase.net/k973782/ 1997-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k973782-aquasil-xlv-smart-wetting-impression-fda-510k.jpg K973782 - AQUASIL XLV SMART WETTING IMPRESSION MATERIAL K973782 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Dec 1997. https://www.510kdatabase.net/k971441/ 1997-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k971441-quanta-lite-toxoplasma-igg-fda-510k.jpg K971441 - QUANTA LITE TOXOPLASMA IGG K971441 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Dec 1997. https://www.510kdatabase.net/k973304/ 1997-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k973304-mvm-33-mm-microendoscope-fda-510k.jpg K973304 - MVM 3.3 MM MICROENDOSCOPE K973304 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Dec 1997. https://www.510kdatabase.net/k971335/ 1997-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k971335-quanta-lite-cmv-igg-elisa-fda-510k.jpg K971335 - QUANTA LITE CMV IGG ELISA K971335 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Dec 1997. https://www.510kdatabase.net/k973496/ 1997-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k973496-the-auto-suture-mibb-system-fda-510k.jpg K973496 - THE AUTO SUTURE* MIBB** SYSTEM K973496 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Dec 1997. https://www.510kdatabase.net/k973928/ 1997-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k973928-beckman-urine-protein-calibrator-ucal-fda-510k.jpg K973928 - BECKMAN URINE PROTEIN CALIBRATOR (UCAL) K973928 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Dec 1997. https://www.510kdatabase.net/k970050/ 1997-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k970050-yasargil-titanium-aneurysm-clips-ftxxxt-fda-510k.jpg K970050 - YASARGIL TITANIUM ANEURYSM CLIPS (FTXXXT) K970050 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Nov 1997. https://www.510kdatabase.net/k973295/ 1997-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k973295-biopolar-button-electrode-wl-150mm-fda-510k.jpg K973295 - BIOPOLAR BUTTON ELECTRODE, WL 150MM, W/SUCTION APPLICATOR/WL 280MM, W/SUCTION APPLICATOR(8801.451 K973295 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Nov 1997. https://www.510kdatabase.net/k964276/ 1997-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k964276-endoscopic-hysterectomy-and-uterus-fda-510k.jpg K964276 - ENDOSCOPIC HYSTERECTOMY AND UTERUS MANIPULATOR K964276 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Nov 1997. https://www.510kdatabase.net/k973228/ 1997-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k973228-sting-skin-prep-wipe59420600sting-skin-fda-510k.jpg K973228 - STING SKIN PREP WIPE(59420600)/STING SKIN PREP SWAB (59420700) K973228 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Nov 1997. https://www.510kdatabase.net/k973230/ 1997-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k973230-monarch-in-2125intellisystem-in-1125-fda-510k.jpg K973230 - MONARCH (IN 2125)/INTELLISYSTEM (IN 1125) K973230 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Nov 1997. https://www.510kdatabase.net/k974103/ 1997-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k974103-abbott-axsym-troponin-i-fda-510k.jpg K974103 - ABBOTT AXSYM TROPONIN-I K974103 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1997. https://www.510kdatabase.net/k963933/ 1997-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k963933-psn-120-hollow-fiber-dialyzer-and-psn-fda-510k.jpg K963933 - PSN-120 HOLLOW FIBER DIALYZER AND PSN-140 HOLLOW FIBER DIALYZER K963933 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Nov 1997. https://www.510kdatabase.net/k971999/ 1997-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k971999-peripherally-inserted-central-fda-510k.jpg K971999 - PERIPHERALLY INSERTED CENTRAL K971999 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Nov 1997. https://www.510kdatabase.net/k972270/ 1997-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k972270-nexgen-complete-knee-solution-convex-fda-510k.jpg K972270 - NEXGEN COMPLETE KNEE SOLUTION CONVEX INSET PATELLA COMPONENT K972270 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Nov 1997. https://www.510kdatabase.net/k973296/ 1997-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k973296-extend-hip-stem-fda-510k.jpg K973296 - EXTEND HIP STEM K973296 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Nov 1997. https://www.510kdatabase.net/k973359/ 1997-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k973359-panoview-plus-telescope-35mm-owl-fda-510k.jpg K973359 - PANOVIEW PLUS TELESCOPE, 3.5MM, O,WL 300MM/25,WL 300MM/0,WL 180MM K973359 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Nov 1997. https://www.510kdatabase.net/k973371/ 1997-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k973371-certodyn-raecg-universal-adapter-fda-510k.jpg K973371 - CERTODYN RAECG UNIVERSAL ADAPTER K973371 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Nov 1997. https://www.510kdatabase.net/k973694/ 1997-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k973694-provil-novo-fda-510k.jpg K973694 - PROVIL NOVO K973694 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Nov 1997. https://www.510kdatabase.net/k973696/ 1997-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k973696-synchron-system-hemoglobin-alc-reagent-fda-510k.jpg K973696 - SYNCHRON SYSTEM HEMOGLOBIN ALC REAGENT K973696 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Nov 1997. https://www.510kdatabase.net/k974050/ 1997-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k974050-synchron-systems-c-reactive-protein-fda-510k.jpg K974050 - SYNCHRON SYSTEMS C-REACTIVE PROTEIN (CRP) REAGENT K974050 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Nov 1997. https://www.510kdatabase.net/k973163/ 1997-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k973163-acetabular-shells-with-mesh-ingrowth-fda-510k.jpg K973163 - ACETABULAR SHELLS WITH MESH INGROWTH SURFACE K973163 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Nov 1997. https://www.510kdatabase.net/k973168/ 1997-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k973168-smartview-options-for-hispeed-cti-fda-510k.jpg K973168 - SMARTVIEW OPTIONS FOR HISPEED CT/I K973168 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Nov 1997. https://www.510kdatabase.net/k973351/ 1997-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k973351-elecsys-afp-fda-510k.jpg K973351 - ELECSYS AFP K973351 is a FDA 510(k) cleared immunology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Nov 1997. https://www.510kdatabase.net/k973369/ 1997-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k973369-roche-unimate-hdl-direct-reagen-with-fda-510k.jpg K973369 - ROCHE UNIMATE HDL DIRECT REAGEN (WITH POL CLAIM) K973369 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Nov 1997. https://www.510kdatabase.net/k973889/ 1997-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k973889-varian-multileaf-collimator-with-fda-510k.jpg K973889 - VARIAN MULTILEAF COLLIMATOR WITH DYNAMIC ARC THERAPY FEATURE K973889 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Nov 1997. https://www.510kdatabase.net/k973164/ 1997-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k973164-howmedica-total-stabilizer-knee-fda-510k.jpg K973164 - HOWMEDICA TOTAL STABILIZER KNEE COMPONENTS K973164 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Nov 1997. https://www.510kdatabase.net/k973240/ 1997-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k973240-synthes-proximal-femoral-nailpfn-fda-510k.jpg K973240 - SYNTHES PROXIMAL FEMORAL NAIL(PFN) SYSTEM MODIFICATION K973240 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Nov 1997. https://www.510kdatabase.net/k973307/ 1997-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k973307-s-rom-zirconia-ceramic-femoral-hip-head-fda-510k.jpg K973307 - S-ROM ZIRCONIA CERAMIC FEMORAL HIP HEAD K973307 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Nov 1997. https://www.510kdatabase.net/k973475/ 1997-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k973475-carmeda-coated-cardiotherm-blood-fda-510k.jpg K973475 - CARMEDA COATED CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS (CBCTXXX SERIES AND CBCTXXXBR SERIES) K973475 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Nov 1997. https://www.510kdatabase.net/k973813/ 1997-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k973813-immunochemistry-system-beta-2-fda-510k.jpg K973813 - IMMUNOCHEMISTRY SYSTEM BETA-2-MICROGLOBULIN REAGENT K973813 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Nov 1997. https://www.510kdatabase.net/k972357/ 1997-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k972357-blue-max-20-balloon-dilatation-catheter-fda-510k.jpg K972357 - BLUE MAX - 20 BALLOON DILATATION CATHETER K972357 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Nov 1997. https://www.510kdatabase.net/k973645/ 1997-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k973645-renegade-fiber-braided-microcatheter-fda-510k.jpg K973645 - RENEGADE FIBER BRAIDED MICROCATHETER K973645 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Nov 1997. https://www.510kdatabase.net/k955829/ 1997-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k955829-safpace-system-fda-510k.jpg K955829 - SAFPACE SYSTEM K955829 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Nov 1997. https://www.510kdatabase.net/k973121/ 1997-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k973121-interax-total-knee-system-fda-510k.jpg K973121 - INTERAX TOTAL KNEE SYSTEM K973121 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Nov 1997. https://www.510kdatabase.net/k973128/ 1997-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k973128-olympus-na-10j-1-aspiration-needle-fda-510k.jpg K973128 - OLYMPUS NA-10J-1 ASPIRATION NEEDLE K973128 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Olympus America, Inc.. Cleared Nov 1997. https://www.510kdatabase.net/k973401/ 1997-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k973401-tempo-4-angiography-catheter-various-fda-510k.jpg K973401 - TEMPO 4 ANGIOGRAPHY CATHETER (VARIOUS) K973401 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Nov 1997. https://www.510kdatabase.net/k973341/ 1997-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k973341-hook-electrode-needle-electrode-fda-510k.jpg K973341 - HOOK ELECTRODE, NEEDLE ELECTRODE, COAGULATION BUTTON ELECTRODE K973341 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Nov 1997. https://www.510kdatabase.net/k973702/ 1997-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k973702-elecsys-vitamin-b12-assay-fda-510k.jpg K973702 - ELECSYS VITAMIN B12 ASSAY K973702 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Nov 1997. https://www.510kdatabase.net/k970654/ 1997-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k970654-cahp-high-performance-cellulose-fda-510k.jpg K970654 - CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER) K970654 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Nov 1997. https://www.510kdatabase.net/k970661/ 1997-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k970661-ca-cellulose-acetate-hollow-fiber-fda-510k.jpg K970661 - CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90) K970661 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Nov 1997. https://www.510kdatabase.net/k972596/ 1997-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k972596-depuy-duraloc-acetabular-cup-system-fda-510k.jpg K972596 - DEPUY DURALOC ACETABULAR CUP SYSTEM K972596 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Nov 1997. https://www.510kdatabase.net/k973131/ 1997-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k973131-sienet-magicweb-web-server-sienet-fda-510k.jpg K973131 - SIENET MAGICWEB (WEB SERVER), SIENET MAGICLINK I (ISI-GATEWAY) K973131 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 1997. https://www.510kdatabase.net/k973674/ 1997-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k973674-elecsys-folate-fda-510k.jpg K973674 - ELECSYS FOLATE K973674 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Nov 1997. https://www.510kdatabase.net/k964407/ 1997-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k964407-imx-ca-15-3-fda-510k.jpg K964407 - IMX CA 15-3 K964407 is a FDA 510(k) cleared immunology medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1997. https://www.510kdatabase.net/k965228/ 1997-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k965228-fasterner-fixation-biodegradable-soft-fda-510k.jpg K965228 - FASTERNER, FIXATION, BIODEGRADABLE SOFT TISSUE K965228 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Nov 1997. https://www.510kdatabase.net/k973010/ 1997-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k973010-realtime-3d-diagnostic-workstation-fda-510k.jpg K973010 - REALTIME 3D DIAGNOSTIC WORKSTATION K973010 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 1997. https://www.510kdatabase.net/k973018/ 1997-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k973018-synthes-mini-lengthening-apparatus-fda-510k.jpg K973018 - SYNTHES MINI LENGTHENING APPARATUS K973018 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Nov 1997. https://www.510kdatabase.net/k973113/ 1997-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k973113-modified-olbert-balloon-catheter-fda-510k.jpg K973113 - MODIFIED OLBERT BALLOON CATHETER SYSTEM, NOPROFILE OLBERT BALLOON CATHETER SYSTEM K973113 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Nov 1997. https://www.510kdatabase.net/k973476/ 1997-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k973476-kodak-digital-science-dental-image-fda-510k.jpg K973476 - KODAK DIGITAL SCIENCE-DENTAL IMAGE VIEWER K973476 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Nov 1997. https://www.510kdatabase.net/k973598/ 1997-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k973598-siremobil-co2-fda-510k.jpg K973598 - SIREMOBIL CO2 K973598 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 1997. https://www.510kdatabase.net/k974075/ 1997-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k974075-access-troponin-i-reagents-on-the-fda-510k.jpg K974075 - ACCESS TROPONIN I REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER K974075 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Nov 1997. https://www.510kdatabase.net/k962554/ 1997-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k962554-flexiflo-low-profile-balloon-fda-510k.jpg K962554 - FLEXIFLO LOW-PROFILE BALLOON GASTROSTOMY TUBE K962554 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1997. https://www.510kdatabase.net/k972927/ 1997-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k972927-endoscopes-wpermanent-and-removable-fda-510k.jpg K972927 - ENDOSCOPES W/PERMANENT AND REMOVABLE EYEPIECE, PANOVIEW PLUS TELESCOPE W/PLUG-ON CONNECTOR K972927 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Nov 1997. https://www.510kdatabase.net/k972962/ 1997-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k972962-3m-cdi-blood-parameter-monitoring-fda-510k.jpg K972962 - 3M CDI BLOOD PARAMETER MONITORING SYSTEM 500 K972962 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: 3M Company. Cleared Nov 1997. https://www.510kdatabase.net/k973007/ 1997-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k973007-datascopes-10-fr-flexisheath-fda-510k.jpg K973007 - DATASCOPE'S 10 FR. FLEXISHEATH PERCUTANEOUS INTRODUCER K973007 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Nov 1997. https://www.510kdatabase.net/k964020/ 1997-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k964020-axsym-ca-125-fda-510k.jpg K964020 - AXSYM CA 125 K964020 is a FDA 510(k) cleared immunology medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1997. https://www.510kdatabase.net/k972696/ 1997-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k972696-il-test-d-dimer-fda-510k.jpg K972696 - IL TEST D-DIMER K972696 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Nov 1997. https://www.510kdatabase.net/k973306/ 1997-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k973306-il-test-aptt-sp-fda-510k.jpg K973306 - IL TEST APTT-SP K973306 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Nov 1997. https://www.510kdatabase.net/k973973/ 1997-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k973973-elecsys-callcheck-digoxin-fda-510k.jpg K973973 - ELECSYS CALLCHECK DIGOXIN K973973 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Nov 1997. https://www.510kdatabase.net/k971730/ 1997-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k971730-depuy-motech-peak-polyaxial-anterior-fda-510k.jpg K971730 - DEPUY MOTECH PEAK POLYAXIAL ANTERIOR CERVICAL PLATE SYSTEM K971730 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Nov 1997. https://www.510kdatabase.net/k972893/ 1997-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k972893-partnership-revision-femoral-stems-fda-510k.jpg K972893 - PARTNERSHIP REVISION FEMORAL STEMS K972893 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Nov 1997. https://www.510kdatabase.net/k973060/ 1997-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k973060-depuy-motech-profile-anterior-fda-510k.jpg K973060 - DEPUY MOTECH PROFILE ANTERIOR THORACOLUMBAR PLATE SYSTEM K973060 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Nov 1997. https://www.510kdatabase.net/k973281/ 1997-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k973281-the-surgical-dynamics-sd-sorb-e-z-tac-fda-510k.jpg K973281 - THE SURGICAL DYNAMICS* S.D. SORB* E-Z TAC* K973281 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Nov 1997. https://www.510kdatabase.net/k973565/ 1997-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k973565-quick-care-biopsy-needle-fda-510k.jpg K973565 - QUICK-CARE BIOPSY NEEDLE K973565 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook, Inc.. Cleared Nov 1997. https://www.510kdatabase.net/k972021/ 1997-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k972021-immulite-third-generation-psa-lkupilkup5-fda-510k.jpg K972021 - IMMULITE THIRD GENERATION PSA (LKUPI,LKUP5) K972021 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Oct 1997. https://www.510kdatabase.net/k973274/ 1997-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k973274-accucolor-high-calibrator-a3089-fda-510k.jpg K973274 - ACCUCOLOR HIGH CALIBRATOR (A3089) K973274 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Oct 1997. https://www.510kdatabase.net/k973743/ 1997-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k973743-access-estradiol-reagents-on-the-fda-510k.jpg K973743 - ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER K973743 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Oct 1997. https://www.510kdatabase.net/k973966/ 1997-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k973966-access-total-t3-reagents-on-the-access-fda-510k.jpg K973966 - ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER K973966 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Oct 1997. https://www.510kdatabase.net/k964661/ 1997-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k964661-hx-2021-1-endoscopic-ligator-fda-510k.jpg K964661 - HX-20/21-1 ENDOSCOPIC LIGATOR K964661 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus America, Inc.. Cleared Oct 1997. https://www.510kdatabase.net/k970162/ 1997-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k970162-neurological-endoscope-fda-510k.jpg K970162 - NEUROLOGICAL ENDOSCOPE K970162 is a FDA 510(k) cleared neurology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Oct 1997. https://www.510kdatabase.net/k971649/ 1997-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k971649-ksea-arthropump-plus-fda-510k.jpg K971649 - KSEA ARTHROPUMP PLUS K971649 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Oct 1997. https://www.510kdatabase.net/k972551/ 1997-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k972551-artisan-pulse-lavage-system-fda-510k.jpg K972551 - ARTISAN PULSE LAVAGE SYSTEM K972551 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Howmedica Corp.. Cleared Oct 1997. https://www.510kdatabase.net/k972863/ 1997-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k972863-duration-stabilized-uhmwpe-knee-fda-510k.jpg K972863 - DURATION STABILIZED UHMWPE KNEE COMPONENTS K972863 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Oct 1997. https://www.510kdatabase.net/k972864/ 1997-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k972864-duration-stabilized-uhmwpe-knee-comp-fda-510k.jpg K972864 - DURATION STABILIZED UHMWPE KNEE COMP., WEAR CLAIMS K972864 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Oct 1997. https://www.510kdatabase.net/k973173/ 1997-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k973173-powerstar-bipolar-scissors-fda-510k.jpg K973173 - POWERSTAR BIPOLAR SCISSORS K973173 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Oct 1997. https://www.510kdatabase.net/k973196/ 1997-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k973196-zeus-scientific-inc-anti-cardiolipin-fda-510k.jpg K973196 - ZEUS SCIENTIFIC, INC., ANTI-CARDIOLIPIN IGA ELISA REAGENTS K973196 is a FDA 510(k) cleared immunology medical device. Manufacturer: Zeus Scientific, Inc.. Cleared Oct 1997. https://www.510kdatabase.net/k963502/ 1997-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k963502-csco-forehead-fixation-system-fda-510k.jpg K963502 - CSCO FOREHEAD FIXATION SYSTEM K963502 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Oct 1997. https://www.510kdatabase.net/k972829/ 1997-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k972829-cricket-2000-recording-pulse-oximeter-fda-510k.jpg K972829 - CRICKET 2000 RECORDING PULSE OXIMETER K972829 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Oct 1997. https://www.510kdatabase.net/k971259/ 1997-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k971259-combiport-fluid-lavage-device-fda-510k.jpg K971259 - COMBIPORT FLUID LAVAGE DEVICE K971259 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Oct 1997. https://www.510kdatabase.net/k972274/ 1997-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k972274-spife-fda-510k.jpg K972274 - SPIFE K972274 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Oct 1997. https://www.510kdatabase.net/k973832/ 1997-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k973832-opus-hlh-controls-fda-510k.jpg K973832 - OPUS HLH CONTROLS K973832 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Oct 1997. https://www.510kdatabase.net/k971680/ 1997-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k971680-auto-suture-bone-wax-fda-510k.jpg K971680 - AUTO SUTURE BONE WAX K971680 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Oct 1997. https://www.510kdatabase.net/k972471/ 1997-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k972471-digital-3-chip-color-video-camera-fda-510k.jpg K972471 - DIGITAL 3-CHIP COLOR VIDEO CAMERA, ILLUMINATORS, VIDEO COMPONENTS AND ACCESSORIES K972471 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 1997. https://www.510kdatabase.net/k973654/ 1997-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k973654-vial-mate-reconstitution-device-2b8071-fda-510k.jpg K973654 - VIAL-MATE RECONSTITUTION DEVICE (2B8071) K973654 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Oct 1997. https://www.510kdatabase.net/k971265/ 1997-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k971265-viking-diagnostic-electrode-catheter-fda-510k.jpg K971265 - VIKING DIAGNOSTIC ELECTRODE CATHETER K971265 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 1997. https://www.510kdatabase.net/k971420/ 1997-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k971420-microendoscope8755401411461451external-fda-510k.jpg K971420 - MICROENDOSCOPE(8755.401,411,461,451)/EXTERNAL SHEATH(8755.221,222)/VERESS CANNULA(8755.211,212) K971420 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Oct 1997. https://www.510kdatabase.net/k973464/ 1997-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k973464-quantex-rf-plus-latex-buffer-standard-fda-510k.jpg K973464 - QUANTEX RF PLUS (LATEX, BUFFER, STANDARD, CONTROL) K973464 is a FDA 510(k) cleared immunology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Oct 1997. https://www.510kdatabase.net/k971436/ 1997-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k971436-nihon-kohden-tec-7511atec-7521a-fda-510k.jpg K971436 - NIHON KOHDEN TEC-7511A/TEC-7521A CARDIOLIFE PORTABLE DEFIBRILLATOR AND ACCESSORIES K971436 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Oct 1997. https://www.510kdatabase.net/k972752/ 1997-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k972752-duracon-conversion-metal-backed-patella-fda-510k.jpg K972752 - DURACON CONVERSION METAL BACKED PATELLA K972752 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Oct 1997. https://www.510kdatabase.net/k972770/ 1997-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k972770-advance-ultra-congruent-tibial-insert-fda-510k.jpg K972770 - ADVANCE ULTRA-CONGRUENT TIBIAL INSERT K972770 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Oct 1997. https://www.510kdatabase.net/k972832/ 1997-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k972832-provision-surgical-helmet-system-fda-510k.jpg K972832 - PROVISION SURGICAL HELMET SYSTEM K972832 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Depuy, Inc.. Cleared Oct 1997. https://www.510kdatabase.net/k972978/ 1997-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k972978-vista-brite-tip-guiding-catheters-fda-510k.jpg K972978 - VISTA BRITE TIP GUIDING CATHETERS K972978 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Oct 1997. https://www.510kdatabase.net/k972260/ 1997-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k972260-cs-400-coagulation-analyzer-system-a1208-fda-510k.jpg K972260 - CS-400 COAGULATION ANALYZER SYSTEM (A1208) K972260 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Oct 1997. https://www.510kdatabase.net/k972929/ 1997-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k972929-n-antiserum-to-human-albumin-fda-510k.jpg K972929 - N ANTISERUM TO HUMAN ALBUMIN K972929 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Oct 1997. https://www.510kdatabase.net/k973006/ 1997-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k973006-quanta-lite-b2-gpi-iga-fda-510k.jpg K973006 - QUANTA LITE B2 GPI IGA K973006 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Oct 1997. https://www.510kdatabase.net/k973014/ 1997-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k973014-quanta-lite-b2gpi-igm-fda-510k.jpg K973014 - QUANTA LITE B2GPI IGM K973014 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Oct 1997. https://www.510kdatabase.net/k971233/ 1997-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k971233-soft-tip-epidural-catheter-kit-fda-510k.jpg K971233 - SOFT TIP EPIDURAL CATHETER KIT K971233 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Oct 1997. https://www.510kdatabase.net/k972714/ 1997-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k972714-siemens-multiview-workstation-infinity-fda-510k.jpg K972714 - SIEMENS MULTIVIEW WORKSTATION INFINITY TELEMETRY SYSTEM K972714 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 1997. https://www.510kdatabase.net/k972840/ 1997-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k972840-n-antiserum-to-human-transferrin-fda-510k.jpg K972840 - N ANTISERUM TO HUMAN TRANSFERRIN K972840 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Oct 1997. https://www.510kdatabase.net/k971137/ 1997-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k971137-bard-rapidfire-multiple-band-ligator-fda-510k.jpg K971137 - BARD RAPIDFIRE MULTIPLE BAND LIGATOR K971137 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 1997. https://www.510kdatabase.net/k971883/ 1997-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k971883-synthes-spine-small-stature-anterior-fda-510k.jpg K971883 - SYNTHES SPINE SMALL STATURE ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM K971883 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Oct 1997. https://www.510kdatabase.net/k972792/ 1997-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k972792-duration-stabilized-uhmwpe-acetabular-fda-510k.jpg K972792 - DURATION STABILIZED UHMWPE ACETABULAR COMPONENTS K972792 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Oct 1997. https://www.510kdatabase.net/k973017/ 1997-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k973017-synthes-combination-clamp-and-fda-510k.jpg K973017 - SYNTHES COMBINATION CLAMP AND DYNAMIZATION CLIP K973017 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Oct 1997. https://www.510kdatabase.net/k973039/ 1997-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k973039-legacylegacy-d-table-fda-510k.jpg K973039 - LEGACY/LEGACY-D TABLE K973039 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Oct 1997. https://www.510kdatabase.net/k973500/ 1997-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k973500-bard-endoscopic-overtube-000307-fda-510k.jpg K973500 - BARD ENDOSCOPIC OVERTUBE (#000307) K973500 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 1997. https://www.510kdatabase.net/k973530/ 1997-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k973530-infinty-distal-femoral-component-fda-510k.jpg K973530 - INFINTY DISTAL FEMORAL COMPONENT K973530 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Oct 1997. https://www.510kdatabase.net/k972690/ 1997-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k972690-zirconia-ceramic-femoral-head-fda-510k.jpg K972690 - ZIRCONIA CERAMIC FEMORAL HEAD K972690 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Oct 1997. https://www.510kdatabase.net/k972691/ 1997-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k972691-abc-total-elbow-prothesis-fda-510k.jpg K972691 - ABC TOTAL ELBOW PROTHESIS K972691 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Oct 1997. https://www.510kdatabase.net/k961008/ 1997-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k961008-automix-33as-compounder-system-fda-510k.jpg K961008 - AUTOMIX 3+3/AS COMPOUNDER SYSTEM K961008 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Oct 1997. https://www.510kdatabase.net/k965112/ 1997-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k965112-medline-catheterization-laboratory-fda-510k.jpg K965112 - MEDLINE CATHETERIZATION LABORATORY TRAYS/KITS/PACKS K965112 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medline Industries, Inc.. Cleared Oct 1997. https://www.510kdatabase.net/k972796/ 1997-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k972796-sigma-diagnostics-thrombomax-with-fda-510k.jpg K972796 - SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUM K972796 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Oct 1997. https://www.510kdatabase.net/k973112/ 1997-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k973112-elecsys-digoxin-fda-510k.jpg K973112 - ELECSYS DIGOXIN K973112 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Oct 1997. https://www.510kdatabase.net/k971320/ 1997-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k971320-cre-balloon-dilatation-catheter-fda-510k.jpg K971320 - CRE BALLOON DILATATION CATHETER K971320 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Oct 1997. https://www.510kdatabase.net/k971858/ 1997-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k971858-sigma-diagnostics-fibrinogen-kit-fda-510k.jpg K971858 - SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A) K971858 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Oct 1997. https://www.510kdatabase.net/k972629/ 1997-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k972629-depuy-ae-tk2-hip-screw-system-fda-510k.jpg K972629 - DEPUY AE TK2 HIP SCREW SYSTEM K972629 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Oct 1997. https://www.510kdatabase.net/k972641/ 1997-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k972641-dual-offset-perfecta-imc-hip-stem-fda-510k.jpg K972641 - DUAL OFFSET PERFECTA IMC HIP STEM K972641 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Oct 1997. https://www.510kdatabase.net/k972813/ 1997-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k972813-gamma-locking-nail-system-fda-510k.jpg K972813 - GAMMA LOCKING NAIL SYSTEM K972813 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Oct 1997. https://www.510kdatabase.net/k972876/ 1997-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k972876-glucotrend-basic-system-fda-510k.jpg K972876 - GLUCOTREND BASIC SYSTEM K972876 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Oct 1997. https://www.510kdatabase.net/k973075/ 1997-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k973075-ontrak-teststik-for-amphetamines-fda-510k.jpg K973075 - ONTRAK TESTSTIK FOR AMPHETAMINES, ONTRAK TESTSTIK FOR COCAINE, ONTRAK TESTSTIK FOR MORPHINE, ONTRAK TESTSTIK FOR PCP, ON K973075 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Oct 1997. https://www.510kdatabase.net/k972926/ 1997-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k972926-mvm-75-french-flexible-choledochoscope-fda-510k.jpg K972926 - MVM 7.5 FRENCH FLEXIBLE CHOLEDOCHOSCOPE K972926 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Oct 1997. https://www.510kdatabase.net/k972825/ 1997-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k972825-opta5-pta-balloon-catheter-powerflex-fda-510k.jpg K972825 - OPTA5 PTA BALLOON CATHETER, POWERFLEX PTA BALLOON CATHETER, ULTRA-THIN DIAMOND BALLOON CATHETER, PALMAZ BALLOON EXPANDAB K972825 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Oct 1997. https://www.510kdatabase.net/k972847/ 1997-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k972847-kodak-digital-science-9000d-medical-fda-510k.jpg K972847 - KODAK DIGITAL SCIENCE 9000D MEDICAL LASER PRINTER (9000D) K972847 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Oct 1997. https://www.510kdatabase.net/k973629/ 1997-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k973629-precinorm-rf-precipath-rf-fda-510k.jpg K973629 - PRECINORM RF, PRECIPATH RF K973629 is a FDA 510(k) cleared immunology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Oct 1997. https://www.510kdatabase.net/k972811/ 1997-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k972811-howmedica-fully-threaded-screws-fda-510k.jpg K972811 - HOWMEDICA FULLY THREADED SCREWS K972811 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Oct 1997. https://www.510kdatabase.net/k973358/ 1997-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k973358-myoglobin-control-set-fda-510k.jpg K973358 - MYOGLOBIN CONTROL SET K973358 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Oct 1997. https://www.510kdatabase.net/k964617/ 1997-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k964617-ge-logiq-700-diagnostic-ultrasound-fda-510k.jpg K964617 - GE LOGIQ 700 DIAGNOSTIC ULTRASOUND SYSTEM K964617 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Oct 1997. https://www.510kdatabase.net/k971056/ 1997-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k971056-magellan-magnetic-distal-targeting-fda-510k.jpg K971056 - MAGELLAN MAGNETIC DISTAL TARGETING SYSTEM(PROPOSED NAME), PRODUCT LINE EXTENSION K971056 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Oct 1997. https://www.510kdatabase.net/k971733/ 1997-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k971733-2-bond-2-fda-510k.jpg K971733 - 2 BOND 2 K971733 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Oct 1997. https://www.510kdatabase.net/k972494/ 1997-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k972494-depuy-dupont-absorbable-set-screw-fda-510k.jpg K972494 - DEPUY DUPONT ABSORBABLE SET SCREW K972494 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Oct 1997. https://www.510kdatabase.net/k972579/ 1997-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k972579-high-dose-disconnect-cap-and-minicap-fda-510k.jpg K972579 - HIGH DOSE DISCONNECT CAP AND MINICAP WITH POVIDONE-IODINE, HIGH DOSE DISCONNECT CAP WITH POVIDONE-IODINE K972579 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Oct 1997. https://www.510kdatabase.net/k972703/ 1997-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k972703-redyrob-closed-wound-drainage-system-fda-510k.jpg K972703 - REDYROB-CLOSED WOUND DRAINAGE SYSTEM K972703 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Oct 1997. https://www.510kdatabase.net/k972891/ 1997-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k972891-abuscreen-online-for-amphetamines-with-fda-510k.jpg K972891 - ABUSCREEN ONLINE FOR AMPHETAMINES WITH PERIODATE - OLYMPUS AU800/1000 INSTRUMENT APPLICATION K972891 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Oct 1997. https://www.510kdatabase.net/k973316/ 1997-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k973316-rep-spe-vis-6040-kit-fda-510k.jpg K973316 - REP SPE VIS-60/40 KIT K973316 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Oct 1997. https://www.510kdatabase.net/k970854/ 1997-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k970854-5-fr-and-6-fr-infiniti-angiographic-fda-510k.jpg K970854 - 5 FR AND 6 FR INFINITI ANGIOGRAPHIC CATHETER K970854 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Sep 1997. https://www.510kdatabase.net/k972101/ 1997-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k972101-solitaire-fda-510k.jpg K972101 - SOLITAIRE K972101 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Sep 1997. https://www.510kdatabase.net/k972626/ 1997-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k972626-advance-knee-system-fda-510k.jpg K972626 - ADVANCE KNEE SYSTEM K972626 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Sep 1997. https://www.510kdatabase.net/k973186/ 1997-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k973186-immulite-cat-specific-ige-immulite-dog-fda-510k.jpg K973186 - IMMULITE CAT-SPECIFIC IGE, IMMULITE DOG-SPECIFIC IGE,IMMULITE MITE-SPECIFIC IGE K973186 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Sep 1997. https://www.510kdatabase.net/k970061/ 1997-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k970061-accutorr-plus-non-invasive-blood-fda-510k.jpg K970061 - ACCUTORR PLUS NON INVASIVE BLOOD PRESSURE MONITOR (0998-00-0117-XX) K970061 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Datascope Corp.. Cleared Sep 1997. https://www.510kdatabase.net/k972460/ 1997-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k972460-osteonics-omnifit-c-cemented-hip-stem-fda-510k.jpg K972460 - OSTEONICS OMNIFIT-C CEMENTED HIP STEM (LINE EXTENSION) K972460 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Sep 1997. https://www.510kdatabase.net/k973204/ 1997-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k973204-osteo-bos-system-in-stainless-steel-fda-510k.jpg K973204 - OSTEO BOS SYSTEM IN STAINLESS STEEL K973204 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Sep 1997. https://www.510kdatabase.net/k972360/ 1997-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k972360-multispect-2-511-kev-collimator-fda-510k.jpg K972360 - MULTISPECT 2 511 KEV COLLIMATOR K972360 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 1997. https://www.510kdatabase.net/k970877/ 1997-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k970877-immulite-cea-fda-510k.jpg K970877 - IMMULITE CEA K970877 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Sep 1997. https://www.510kdatabase.net/k972743/ 1997-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k972743-sigma-diagnostics-creatinine-reagent-fda-510k.jpg K972743 - SIGMA DIAGNOSTICS CREATININE REAGENT, SIGMA DIAGNOSTICS CREATININE REAGENT K972743 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Sep 1997. https://www.510kdatabase.net/k972963/ 1997-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k972963-modified-cedia-dau-pcp-assay-fda-510k.jpg K972963 - MODIFIED CEDIA DAU PCP ASSAY K972963 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Sep 1997. https://www.510kdatabase.net/k973069/ 1997-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k973069-synchron-systems-methadone-reagent-fda-510k.jpg K973069 - SYNCHRON SYSTEMS METHADONE REAGENT K973069 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Sep 1997. https://www.510kdatabase.net/k972415/ 1997-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k972415-minisitebipolar-forceps-device-fda-510k.jpg K972415 - MINISITE*BIPOLAR FORCEPS** DEVICE K972415 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Sep 1997. https://www.510kdatabase.net/k972568/ 1997-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k972568-depuy-motech-moss-miami-spinal-system-fda-510k.jpg K972568 - DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM K972568 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Sep 1997. https://www.510kdatabase.net/k972692/ 1997-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k972692-marchetti-vicenzi-intramedullary-nail-fda-510k.jpg K972692 - MARCHETTI-VICENZI INTRAMEDULLARY NAIL, HUMERAL K972692 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Sep 1997. https://www.510kdatabase.net/k972354/ 1997-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k972354-abbott-cell-dyn-3200-system-fda-510k.jpg K972354 - ABBOTT CELL-DYN 3200 SYSTEM K972354 is a FDA 510(k) cleared hematology medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1997. https://www.510kdatabase.net/k972573/ 1997-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k972573-liqcrylic-pro-dental-resin-fda-510k.jpg K972573 - LIQCRYLIC PRO DENTAL RESIN K972573 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Sep 1997. https://www.510kdatabase.net/k963926/ 1997-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k963926-axsym-ca-15-3-fda-510k.jpg K963926 - AXSYM CA 15-3 K963926 is a FDA 510(k) cleared immunology medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1997. https://www.510kdatabase.net/k971315/ 1997-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k971315-auxiliary-instruments-for-urs-fda-510k.jpg K971315 - AUXILIARY INSTRUMENTS FOR URS K971315 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Sep 1997. https://www.510kdatabase.net/k970544/ 1997-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k970544-depuy-dupont-orthopaedics-finger-joint-fda-510k.jpg K970544 - DEPUY DUPONT ORTHOPAEDICS FINGER JOINT PROSTHESIS K970544 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Sep 1997. https://www.510kdatabase.net/k973202/ 1997-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k973202-modification-of-opus-ferritin-test-fda-510k.jpg K973202 - MODIFICATION OF OPUS FERRITIN TEST SYSTEM K973202 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Sep 1997. https://www.510kdatabase.net/k964624/ 1997-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k964624-siemens-sc9000sc9015-bedside-fda-510k.jpg K964624 - SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM K964624 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 1997. https://www.510kdatabase.net/k971869/ 1997-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k971869-finesse-all-ceramic-system-fda-510k.jpg K971869 - FINESSE ALL-CERAMIC SYSTEM K971869 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Sep 1997. https://www.510kdatabase.net/k972380/ 1997-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k972380-kodak-digital-science-kds-medical-fda-510k.jpg K972380 - KODAK DIGITAL SCIENCE (KDS) MEDICAL IMAGE AND INFORMATION LIBRARY (MIIL) K972380 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Sep 1997. https://www.510kdatabase.net/k972435/ 1997-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k972435-ultima-and-ultima-lx-cemented-femoral-fda-510k.jpg K972435 - ULTIMA AND ULTIMA LX CEMENTED FEMORAL STEM K972435 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Sep 1997. https://www.510kdatabase.net/k972479/ 1997-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k972479-alta-plating-system-fda-510k.jpg K972479 - ALTA PLATING SYSTEM K972479 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Sep 1997. https://www.510kdatabase.net/k972323/ 1997-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k972323-osteo-bos-system-fda-510k.jpg K972323 - OSTEO BOS SYSTEM K972323 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Sep 1997. https://www.510kdatabase.net/k972412/ 1997-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k972412-prolene-polypropylene-mesh-hernia-fda-510k.jpg K972412 - PROLENE POLYPROPYLENE MESH HERNIA DEVICE NONABSORBABLE SYNTHETIC SURGICAL MESH K972412 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Sep 1997. https://www.510kdatabase.net/k970591/ 1997-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k970591-blood-monitor-pump-fda-510k.jpg K970591 - BLOOD MONITOR PUMP K970591 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Sep 1997. https://www.510kdatabase.net/k972316/ 1997-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k972316-opus-d-dimer-fda-510k.jpg K972316 - OPUS D-DIMER K972316 is a FDA 510(k) cleared hematology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Sep 1997. https://www.510kdatabase.net/k960527/ 1997-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k960527-logiq-1000-diagnostic-ultrsound-system-fda-510k.jpg K960527 - LOGIQ 1000 DIAGNOSTIC ULTRSOUND SYSTEM K960527 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Sep 1997. https://www.510kdatabase.net/k972275/ 1997-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k972275-lantis-treatstation-fda-510k.jpg K972275 - LANTIS TREATSTATION K972275 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 1997. https://www.510kdatabase.net/k972519/ 1997-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k972519-grasping-forceps-right-and-left-curved-fda-510k.jpg K972519 - GRASPING FORCEPS, RIGHT AND LEFT CURVED K972519 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Sep 1997. https://www.510kdatabase.net/k972855/ 1997-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k972855-karl-storz-contact-nasal-micro-fda-510k.jpg K972855 - KARL STORZ CONTACT NASAL MICRO-ENDOSCOPES K972855 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Sep 1997. https://www.510kdatabase.net/k970627/ 1997-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k970627-e-cam-coincidence-mode-cm-fda-510k.jpg K970627 - E. CAM COINCIDENCE MODE (CM) K970627 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 1997. https://www.510kdatabase.net/k972516/ 1997-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k972516-synthes-usa-flexible-humeral-nailflex-fda-510k.jpg K972516 - SYNTHES (USA) FLEXIBLE HUMERAL NAIL(FLEX NAIL) SYSTEM K972516 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Sep 1997. https://www.510kdatabase.net/k973222/ 1997-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k973222-sc9000sc9015-medical-information-bus-fda-510k.jpg K973222 - SC9000/SC9015 MEDICAL INFORMATION BUS (MIB) PROTOCOL CONVERTER K973222 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 1997. https://www.510kdatabase.net/k971717/ 1997-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k971717-fly-through-fda-510k.jpg K971717 - FLY THROUGH K971717 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 1997. https://www.510kdatabase.net/k972113/ 1997-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k972113-30-cc-and-40-cc-sub-9-nitinol-and-30-fda-510k.jpg K972113 - 30 CC AND 40 CC SUB-9 NITINOL AND 30 AND 40 CC SUB-9 STAINLESS STEEL K972113 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Sep 1997. https://www.510kdatabase.net/k962167/ 1997-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k962167-bronchial-blocker-fda-510k.jpg K962167 - BRONCHIAL BLOCKER K962167 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Cook, Inc.. Cleared Aug 1997. https://www.510kdatabase.net/k970296/ 1997-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k970296-rotablator-rotational-angioplasty-fda-510k.jpg K970296 - ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM WITH THE ROTALINK EXCHANGEABLE CATHETER K970296 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Aug 1997. https://www.510kdatabase.net/k972355/ 1997-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k972355-3m-aurora-system-fda-510k.jpg K972355 - 3M AURORA SYSTEM K972355 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Aug 1997. https://www.510kdatabase.net/k971166/ 1997-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k971166-optical-mediastinoscope-with-plug-in-fda-510k.jpg K971166 - OPTICAL MEDIASTINOSCOPE WITH PLUG-IN CONNECTION/OCULAR EYEPIECE K971166 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Aug 1997. https://www.510kdatabase.net/k972497/ 1997-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k972497-karl-storz-monopolar-coagulating-fda-510k.jpg K972497 - KARL STORZ MONOPOLAR COAGULATING ELECTRODES/ KARL STORZ MONOPOLAR COAGULATING NEEDLE ELECTRODES K972497 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Aug 1997. https://www.510kdatabase.net/k971397/ 1997-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k971397-viewcath-3-d-catheter-pullback-fda-510k.jpg K971397 - VIEWCATH 3-D CATHETER PULLBACK K971397 is a FDA 510(k) cleared radiology medical device. Manufacturer: Quinton, Inc.. Cleared Aug 1997. https://www.510kdatabase.net/k971938/ 1997-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k971938-repicci-ii-unicondylar-knee-fda-510k.jpg K971938 - REPICCI II UNICONDYLAR KNEE K971938 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Aug 1997. https://www.510kdatabase.net/k971973/ 1997-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k971973-kodak-digital-science-pro-medical-fda-510k.jpg K971973 - KODAK DIGITAL SCIENCE PRO-MEDICAL THERMAL PRINTER K971973 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Aug 1997. https://www.510kdatabase.net/k972196/ 1997-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k972196-osteo-anatomical-bone-plates-fda-510k.jpg K972196 - OSTEO ANATOMICAL BONE PLATES K972196 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Aug 1997. https://www.510kdatabase.net/k972043/ 1997-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k972043-medtronic-model-32733274-rf-receiver-fda-510k.jpg K972043 - MEDTRONIC MODEL 3273/3274 RF RECEIVER AND MODEL 3629/3630 SCREENER K972043 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Aug 1997. https://www.510kdatabase.net/k972095/ 1997-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k972095-immulite-2000-psa-fda-510k.jpg K972095 - IMMULITE 2000 PSA K972095 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Aug 1997. https://www.510kdatabase.net/k971884/ 1997-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k971884-asset-apollo-fda-510k.jpg K971884 - ASSET APOLLO K971884 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Aug 1997. https://www.510kdatabase.net/k971894/ 1997-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k971894-kodak-digital-science-dental-scanning-fda-510k.jpg K971894 - KODAK DIGITAL SCIENCE - DENTAL SCANNING SYSTEM K971894 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Aug 1997. https://www.510kdatabase.net/k971906/ 1997-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k971906-jejenostomy-feeding-tube-fda-510k.jpg K971906 - JEJENOSTOMY FEEDING TUBE K971906 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Aug 1997. https://www.510kdatabase.net/k971958/ 1997-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k971958-synchron-lx-systems-transferrin-trfn-fda-510k.jpg K971958 - SYNCHRON LX SYSTEMS TRANSFERRIN (TRFN) REAGENT K971958 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Aug 1997. https://www.510kdatabase.net/k972310/ 1997-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k972310-nihon-kohden-qp-932e-ecg-exercise-test-fda-510k.jpg K972310 - NIHON KOHDEN QP-932E ECG EXERCISE TEST OPTION FOR THE NIHON KOHDEN ECG-9320/A CARDIOFAX ELECTROCARDIOGRAPH K972310 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Aug 1997. https://www.510kdatabase.net/k971870/ 1997-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k971870-lactosorb-trauma-plating-system-fda-510k.jpg K971870 - LACTOSORB TRAUMA PLATING SYSTEM K971870 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Aug 1997. https://www.510kdatabase.net/k972861/ 1997-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k972861-il-test-contril-spectrum-levels-1-2-fda-510k.jpg K972861 - IL TEST CONTRIL SPECTRUM (LEVELS 1, 2 AND 3) K972861 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Aug 1997. https://www.510kdatabase.net/k970348/ 1997-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k970348-siemens-sc9000sc9015-series-surgical-fda-510k.jpg K970348 - SIEMENS SC/9000/SC9015 SERIES SURGICAL DISPLAY CONTROLLER K970348 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 1997. https://www.510kdatabase.net/k971839/ 1997-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k971839-varian-radiation-therapy-imaging-system-fda-510k.jpg K971839 - VARIAN RADIATION THERAPY IMAGING SYSTEM K971839 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Aug 1997. https://www.510kdatabase.net/k971937/ 1997-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k971937-climber-partially-coated-guide-wire-fda-510k.jpg K971937 - CLIMBER - PARTIALLY COATED GUIDE WIRE FOR ENDOSCOPIC USE K971937 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Terumo Medical Corp.. Cleared Aug 1997. https://www.510kdatabase.net/k972363/ 1997-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k972363-il-test-iron-fda-510k.jpg K972363 - IL TEST IRON K972363 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Aug 1997. https://www.510kdatabase.net/k970241/ 1997-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k970241-depuy-proximal-femoral-replacement-fda-510k.jpg K970241 - DEPUY PROXIMAL FEMORAL REPLACEMENT PROSTHESIS K970241 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Aug 1997. https://www.510kdatabase.net/k972110/ 1997-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k972110-cordis-endeavor-infusion-catheter-fda-510k.jpg K972110 - Cordis Endeavor Infusion Catheter K972110 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Aug 1997. https://www.510kdatabase.net/k964784/ 1997-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k964784-synergy-cardiology-information-system-fda-510k.jpg K964784 - SYNERGY CARDIOLOGY INFORMATION SYSTEM (00431) K964784 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Aug 1997. https://www.510kdatabase.net/k972819/ 1997-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k972819-vigil-tdm-controls-fda-510k.jpg K972819 - VIGIL TDM CONTROLS K972819 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Aug 1997. https://www.510kdatabase.net/k970511/ 1997-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k970511-dyonics-disposable-endoscopic-surgery-fda-510k.jpg K970511 - DYONICS DISPOSABLE ENDOSCOPIC SURGERY BLADES K970511 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Aug 1997. https://www.510kdatabase.net/k971152/ 1997-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k971152-abbott-cell-dyn-4000-immature-fda-510k.jpg K971152 - ABBOTT CELL-DYN 4000 IMMATURE RETICULOCYTE FRACTION (IRF) K971152 is a FDA 510(k) cleared hematology medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1997. https://www.510kdatabase.net/k971850/ 1997-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k971850-smith-nephew-images-endoscopes-and-fda-510k.jpg K971850 - SMITH & NEPHEW IMAGES ENDOSCOPES AND ACCESSORIES K971850 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Aug 1997. https://www.510kdatabase.net/k971977/ 1997-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k971977-ksea-155-fr-flexible-choledocho-fda-510k.jpg K971977 - KSEA 15.5 FR. FLEXIBLE CHOLEDOCHO-FIBERSCOPE K971977 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Aug 1997. https://www.510kdatabase.net/k971982/ 1997-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k971982-karl-storz-model-203020-20-equimat-fda-510k.jpg K971982 - KARL STORZ MODEL 203020 20 EQUIMAT K971982 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Aug 1997. https://www.510kdatabase.net/k972108/ 1997-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k972108-alta-intramedullary-rod-system-fda-510k.jpg K972108 - ALTA INTRAMEDULLARY ROD SYSTEM K972108 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Aug 1997. https://www.510kdatabase.net/k972235/ 1997-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k972235-precicontrol-tumor-marker-1-and-2-fda-510k.jpg K972235 - PRECICONTROL TUMOR MARKER 1 AND 2 K972235 is a FDA 510(k) cleared immunology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Aug 1997. https://www.510kdatabase.net/k972250/ 1997-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k972250-roche-cobas-integra-reagent-cassettes-fda-510k.jpg K972250 - ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS K972250 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Aug 1997. https://www.510kdatabase.net/k964431/ 1997-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k964431-zirconia-ceramic-modular-heads-norton-fda-510k.jpg K964431 - ZIRCONIA CERAMIC MODULAR HEADS (NORTON ADVANCED CERAMICS) K964431 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Aug 1997. https://www.510kdatabase.net/k971962/ 1997-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k971962-osteo-kirschner-wires-fda-510k.jpg K971962 - OSTEO KIRSCHNER WIRES K971962 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Aug 1997. https://www.510kdatabase.net/k972504/ 1997-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k972504-mvm-33-mm-microendoscope-fda-510k.jpg K972504 - MVM 3.3 MM MICROENDOSCOPE K972504 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Aug 1997. https://www.510kdatabase.net/k971890/ 1997-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k971890-recovery-protrusio-cage-fda-510k.jpg K971890 - RECOVERY PROTRUSIO CAGE K971890 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Aug 1997. https://www.510kdatabase.net/k972609/ 1997-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k972609-variant-express-glycohemoglobin-program-fda-510k.jpg K972609 - VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM K972609 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bio-Rad. Cleared Aug 1997. https://www.510kdatabase.net/k972721/ 1997-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k972721-roche-hemoglobin-a1c-control-n-and-fda-510k.jpg K972721 - ROCHE HEMOGLOBIN A1C CONTROL N AND CONTROL P K972721 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Aug 1997. https://www.510kdatabase.net/k971673/ 1997-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k971673-40-cc-sumo-fda-510k.jpg K971673 - 40 CC SUMO K971673 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Aug 1997. https://www.510kdatabase.net/k971684/ 1997-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k971684-magnetom-project-047-system-numaris-35-fda-510k.jpg K971684 - MAGNETOM PROJECT 047 SYSTEM (NUMARIS 3.5 SOFTWARE) K971684 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 1997. https://www.510kdatabase.net/k970048/ 1997-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k970048-synthesusatitanium-locking-plate-fda-510k.jpg K970048 - SYNTHES(USA)TITANIUM LOCKING PLATE SYSTEM(TILPS) K970048 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Aug 1997. https://www.510kdatabase.net/k970926/ 1997-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k970926-double-lumen-picc-fda-510k.jpg K970926 - DOUBLE LUMEN PICC K970926 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Aug 1997. https://www.510kdatabase.net/k965001/ 1997-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k965001-intuitive-surgical-monarch-fda-510k.jpg K965001 - INTUITIVE SURGICAL MONARCH LAPAROSCOPIC MANIPULATOR K965001 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intuitive Surgical, Inc.. Cleared Jul 1997. https://www.510kdatabase.net/k970207/ 1997-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k970207-medi-tech-5-french-nighthawk-selective-fda-510k.jpg K970207 - MEDI-TECH 5 FRENCH NIGHTHAWK SELECTIVE ANGIOGRAPHIC CATHETERS K970207 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Jul 1997. https://www.510kdatabase.net/k972794/ 1997-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k972794-digoxin-dg-ii-fpia-reagent-set-fda-510k.jpg K972794 - DIGOXIN DG-II FPIA REAGENT SET K972794 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Jul 1997. https://www.510kdatabase.net/k964282/ 1997-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k964282-tina-quant-ferritin-assay-fda-510k.jpg K964282 - TINA-QUANT FERRITIN ASSAY K964282 is a FDA 510(k) cleared immunology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jul 1997. https://www.510kdatabase.net/k970793/ 1997-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k970793-implantable-clip-fda-510k.jpg K970793 - IMPLANTABLE CLIP K970793 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Jul 1997. https://www.510kdatabase.net/k971723/ 1997-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k971723-fastak-suture-anchor-117mm75mm-fda-510k.jpg K971723 - FASTAK SUTURE ANCHOR (11.7MM)/(7.5MM) K971723 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jul 1997. https://www.510kdatabase.net/k971752/ 1997-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k971752-zirconia-ceramic-femoral-head-1214-taper-fda-510k.jpg K971752 - ZIRCONIA CERAMIC FEMORAL HEAD (12/14 TAPER) K971752 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jul 1997. https://www.510kdatabase.net/k971800/ 1997-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k971800-osteo-cannulated-screw-system-fda-510k.jpg K971800 - OSTEO CANNULATED SCREW SYSTEM K971800 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Jul 1997. https://www.510kdatabase.net/k971854/ 1997-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k971854-osteolock-acetabular-shell-system-fda-510k.jpg K971854 - OSTEOLOCK ACETABULAR SHELL SYSTEM K971854 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jul 1997. https://www.510kdatabase.net/k972024/ 1997-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k972024-coda-automated-eia-analyzer-fda-510k.jpg K972024 - CODA AUTOMATED EIA ANALYZER K972024 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Jul 1997. https://www.510kdatabase.net/k972132/ 1997-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k972132-sigma-diagnostics-valproic-acid-fpia-fda-510k.jpg K972132 - SIGMA DIAGNOSTICS VALPROIC ACID FPIA REAGENT SET, SIGMA DIAGNOSTICS VALPROIC ACID FPIA CALIBRATORS K972132 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Jul 1997. https://www.510kdatabase.net/k964886/ 1997-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k964886-ge-logiq-700-diagnostic-ultrasound-fda-510k.jpg K964886 - GE LOGIQ 700 DIAGNOSTIC ULTRASOUND SYSTEM K964886 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Jul 1997. https://www.510kdatabase.net/k970920/ 1997-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k970920-siemens-sc9000sc9015-bedside-fda-510k.jpg K970920 - SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM K970920 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 1997. https://www.510kdatabase.net/k972513/ 1997-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k972513-tinaquant-myoglobin-assay-fda-510k.jpg K972513 - TINAQUANT MYOGLOBIN ASSAY K972513 is a FDA 510(k) cleared immunology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jul 1997. https://www.510kdatabase.net/k964351/ 1997-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k964351-elecsys-psa-assay-fda-510k.jpg K964351 - ELECSYS PSA ASSAY K964351 is a FDA 510(k) cleared immunology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jul 1997. https://www.510kdatabase.net/k971660/ 1997-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k971660-olympus-gf-um130-ultrasound-fda-510k.jpg K971660 - OLYMPUS GF-UM130 ULTRASOUND GASTROVIDEOSCOPE, ITS ASSOCIATED ACCESSORIES AND ANCILLARY EQUIPMENT K971660 is a FDA 510(k) cleared radiology medical device. Manufacturer: Olympus America, Inc.. Cleared Jul 1997. https://www.510kdatabase.net/k971792/ 1997-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k971792-immulite-free-t4-2-step-fda-510k.jpg K971792 - IMMULITE FREE T4 (2-STEP) K971792 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jul 1997. https://www.510kdatabase.net/k972116/ 1997-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k972116-von-willebrand-reagent-fda-510k.jpg K972116 - VON WILLEBRAND REAGENT K972116 is a FDA 510(k) cleared hematology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Jul 1997. https://www.510kdatabase.net/k972144/ 1997-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k972144-sigma-diagnostics-accucolor-fda-510k.jpg K972144 - SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III K972144 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Jul 1997. https://www.510kdatabase.net/k971180/ 1997-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k971180-bard-no-rinse-hemoconcentrator-and-fda-510k.jpg K971180 - BARD NO-RINSE HEMOCONCENTRATOR AND ACCESSORY KIT K971180 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jul 1997. https://www.510kdatabase.net/k971518/ 1997-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k971518-ksea-semi-rigid-hysteroscope-and-fda-510k.jpg K971518 - KSEA SEMI-RIGID HYSTEROSCOPE AND ACCESSORIES K971518 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jul 1997. https://www.510kdatabase.net/k971607/ 1997-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k971607-medi-tech-4-and-5-french-nighthawk-fda-510k.jpg K971607 - MEDI-TECH 4 AND 5 FRENCH NIGHTHAWK FLUSH ANGIOGRAPHIC CATHETERS K971607 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Jul 1997. https://www.510kdatabase.net/k971668/ 1997-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k971668-signa-profile-wrist-coil-and-mobile-fda-510k.jpg K971668 - SIGNA PROFILE WRIST COIL AND MOBILE SITING OPTIONS K971668 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Jul 1997. https://www.510kdatabase.net/k971742/ 1997-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k971742-depuy-orthotech-heavy-duty-vest-fda-510k.jpg K971742 - DEPUY ORTHOTECH HEAVY DUTY VEST RESTRAINT K971742 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Depuy, Inc.. Cleared Jul 1997. https://www.510kdatabase.net/k972348/ 1997-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k972348-hp-endovaginalendorectal-probe-hp-fda-510k.jpg K972348 - HP ENDOVAGINAL/ENDORECTAL PROBE, HP IMAGE POINT ULTRASOUND SYSTEM K972348 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Jul 1997. https://www.510kdatabase.net/k972433/ 1997-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k972433-cedia-digoxin-calibrators-fda-510k.jpg K972433 - CEDIA DIGOXIN CALIBRATORS K972433 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jul 1997. https://www.510kdatabase.net/k965010/ 1997-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k965010-target-2-version-11-fda-510k.jpg K965010 - TARGET 2 VERSION 1.1 K965010 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Jul 1997. https://www.510kdatabase.net/k971165/ 1997-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k971165-introducer-sheath-and-dilator-fda-510k.jpg K971165 - INTRODUCER SHEATH AND DILATOR K971165 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Jul 1997. https://www.510kdatabase.net/k971516/ 1997-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k971516-cordis-powerflex-plus-pta-balloon-fda-510k.jpg K971516 - CORDIS POWERFLEX PLUS PTA BALLOON CATHETER K971516 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Jul 1997. https://www.510kdatabase.net/k971667/ 1997-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k971667-cardiac-phased-array-coil-fda-510k.jpg K971667 - CARDIAC PHASED ARRAY COIL K971667 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Jul 1997. https://www.510kdatabase.net/k972159/ 1997-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k972159-fenwal-40-micron-transfusion-filter-fda-510k.jpg K972159 - FENWAL 40 MICRON TRANSFUSION FILTER K972159 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jul 1997. https://www.510kdatabase.net/k962950/ 1997-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k962950-cadplan-version-262-radiation-therapy-fda-510k.jpg K962950 - CADPLAN, VERSION 2.62. RADIATION THERAPY TREATMENT PLANNING SYSTEM K962950 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Jul 1997. https://www.510kdatabase.net/k963898/ 1997-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k963898-model-6495-bipolar-temporary-pacing-lead-fda-510k.jpg K963898 - MODEL 6495 BIPOLAR TEMPORARY PACING LEAD K963898 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jul 1997. https://www.510kdatabase.net/k971620/ 1997-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k971620-quanta-lite-rubeola-measles-igg-fda-510k.jpg K971620 - QUANTA LITE RUBEOLA (MEASLES) IGG K971620 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Jul 1997. https://www.510kdatabase.net/k972011/ 1997-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k972011-opus-ethanol-fda-510k.jpg K972011 - OPUS ETHANOL K972011 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Jul 1997. https://www.510kdatabase.net/k972041/ 1997-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k972041-ez-hdl-cholesterol-reagentprocedure-fda-510k.jpg K972041 - EZ HDL CHOLESTEROL REAGENT(PROCEDURE 354)/EZ HDL CALIBRATOR (354-5) K972041 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Jul 1997. https://www.510kdatabase.net/k972404/ 1997-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k972404-vacutainer-brand-safety-blood-fda-510k.jpg K972404 - VACUTAINER BRAND SAFETY BLOOD COLLECTION ASSEMBLY(MULTIPLE) K972404 is a FDA 510(k) cleared pathology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jul 1997. https://www.510kdatabase.net/k971608/ 1997-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k971608-cordis-brite-tip-catheter-sheath-fda-510k.jpg K971608 - CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM K971608 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Jul 1997. https://www.510kdatabase.net/k971310/ 1997-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k971310-aesculap-jet-irrigation-system-fda-510k.jpg K971310 - AESCULAP JET IRRIGATION SYSTEM K971310 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Jul 1997. https://www.510kdatabase.net/k971446/ 1997-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k971446-3m-universal-electrosurgical-pad-fda-510k.jpg K971446 - 3M UNIVERSAL ELECTROSURGICAL PAD SPLIT/SOLID(9130&9160) K971446 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3M Company. Cleared Jul 1997. https://www.510kdatabase.net/k971579/ 1997-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k971579-cordis-opta-5-pta-balloon-catheter-fda-510k.jpg K971579 - CORDIS OPTA 5 PTA BALLOON CATHETER K971579 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Jul 1997. https://www.510kdatabase.net/k971783/ 1997-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k971783-synthes-elastic-intramedullary-nail-fda-510k.jpg K971783 - SYNTHES ELASTIC INTRAMEDULLARY NAIL (EIN) SYSTEM K971783 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jul 1997. https://www.510kdatabase.net/k971816/ 1997-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k971816-atlas-fracture-proximal-humeral-nail-fda-510k.jpg K971816 - ATLAS FRACTURE PROXIMAL HUMERAL NAIL K971816 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jul 1997. https://www.510kdatabase.net/k971189/ 1997-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k971189-pfc-sigma-knee-system-size-15-fda-510k.jpg K971189 - P.F.C. SIGMA KNEE SYSTEM (SIZE 1.5) K971189 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jul 1997. https://www.510kdatabase.net/k971755/ 1997-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k971755-hoffmann-ii-compact-external-fixation-fda-510k.jpg K971755 - HOFFMANN II COMPACT EXTERNAL FIXATION SYSTEM K971755 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jul 1997. https://www.510kdatabase.net/k971416/ 1997-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k971416-olympus-oes-otv-s5c-video-system-fda-510k.jpg K971416 - OLYMPUS OES OTV-S5C VIDEO SYSTEM K971416 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus America, Inc.. Cleared Jul 1997. https://www.510kdatabase.net/k971497/ 1997-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k971497-osteonics-anteverted-neck-hip-stem-fda-510k.jpg K971497 - OSTEONICS ANTEVERTED NECK HIP STEM K971497 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Jul 1997. https://www.510kdatabase.net/k971652/ 1997-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k971652-pfc-sigma-inset-patella-fda-510k.jpg K971652 - P.F.C. SIGMA INSET PATELLA K971652 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jul 1997. https://www.510kdatabase.net/k971741/ 1997-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k971741-dall-miles-homogeneous-stainless-steel-fda-510k.jpg K971741 - DALL-MILES HOMOGENEOUS STAINLESS STEEL CABLE AND BEADED CABLE K971741 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jul 1997. https://www.510kdatabase.net/k965068/ 1997-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k965068-magnetic-resonanc-dvce-visart-v-35-fda-510k.jpg K965068 - MAGNETIC RESONANC DVCE VISART V 3.5 SOFTWARE K965068 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Jul 1997. https://www.510kdatabase.net/k971168/ 1997-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k971168-one-dayfive-dayseven-day-syringe-mate-fda-510k.jpg K971168 - ONE-DAY/FIVE-DAY/SEVEN-DAY SYRINGE MATE K971168 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jul 1997. https://www.510kdatabase.net/k971355/ 1997-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k971355-nihon-kohden-tec-7531-cardiolife-fda-510k.jpg K971355 - NIHON KOHDEN TEC-7531 CARDIOLIFE PORTABLE DEFIBRILLATOR AND ACCESSORIES K971355 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Jul 1997. https://www.510kdatabase.net/k963565/ 1997-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k963565-mri-needles-fda-510k.jpg K963565 - MRI NEEDLES K963565 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook, Inc.. Cleared Jul 1997. https://www.510kdatabase.net/k971474/ 1997-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k971474-medtronic-model-5318-temporary-fda-510k.jpg K971474 - MEDTRONIC MODEL 5318 TEMPORARY PACEMAKER/IMPLANT TOOL K971474 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jul 1997. https://www.510kdatabase.net/k971572/ 1997-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k971572-vista-brite-tip-catheters-fda-510k.jpg K971572 - VISTA BRITE TIP CATHETERS K971572 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Jul 1997. https://www.510kdatabase.net/k971646/ 1997-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k971646-4f-nylex-angiography-catheter5f-nylex-fda-510k.jpg K971646 - 4F NYLEX ANGIOGRAPHY CATHETER/5F NYLEX ANGIOGRAPHY CATHETER K971646 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Jul 1997. https://www.510kdatabase.net/k971194/ 1997-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k971194-nihon-kohden-tec-6100a-cardiolife-mini-fda-510k.jpg K971194 - NIHON KOHDEN TEC-6100A CARDIOLIFE MINI DEFIBRILLATOR & ACCESSORIES K971194 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Jul 1997. https://www.510kdatabase.net/k971321/ 1997-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k971321-osteo-compression-condyle-screw-system-fda-510k.jpg K971321 - OSTEO COMPRESSION CONDYLE SCREW SYSTEM K971321 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Jul 1997. https://www.510kdatabase.net/k971358/ 1997-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k971358-bio-interference-screw-7-mm-8-mm-9-mm-fda-510k.jpg K971358 - BIO-INTERFERENCE SCREW, 7 MM, 8 MM, 9 MM K971358 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jul 1997. https://www.510kdatabase.net/k971409/ 1997-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k971409-osteonics-alumina-c-taper-head-fda-510k.jpg K971409 - OSTEONICS ALUMINA C-TAPER HEAD K971409 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Jul 1997. https://www.510kdatabase.net/k971429/ 1997-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k971429-interseal-acetabular-screw-hole-plug-fda-510k.jpg K971429 - INTERSEAL ACETABULAR SCREW HOLE PLUG K971429 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jul 1997. https://www.510kdatabase.net/k971654/ 1997-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k971654-osteo-compression-hip-screw-system-fda-510k.jpg K971654 - OSTEO COMPRESSION HIP SCREW SYSTEM K971654 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Jul 1997. https://www.510kdatabase.net/k971550/ 1997-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k971550-kinematic-all-polyethylene-patella-fda-510k.jpg K971550 - KINEMATIC ALL-POLYETHYLENE PATELLA WITH THREE PEGS K971550 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jul 1997. https://www.510kdatabase.net/k961734/ 1997-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k961734-capiox-308-hollow-fiber-oxygenator-fda-510k.jpg K961734 - CAPIOX 308 HOLLOW FIBER OXYGENATOR W/INTEGRATED HEAT EXCHANGE K961734 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Jul 1997. https://www.510kdatabase.net/k971060/ 1997-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k971060-precinorm-tdm-controls-fda-510k.jpg K971060 - PRECINORM TDM CONTROLS K971060 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jul 1997. https://www.510kdatabase.net/k964172/ 1997-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k964172-medtronic-model-3991a-3992a-3993a-fda-510k.jpg K964172 - MEDTRONIC MODEL 3991A, 3992A, 3993A, 3994A LEADS OR TRANSVERSE TRIPOLAR LEADS OR TTL K964172 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Jul 1997. https://www.510kdatabase.net/k971448/ 1997-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k971448-cordis-opta-lp-pta-balloon-catheter-fda-510k.jpg K971448 - CORDIS OPTA LP PTA BALLOON CATHETER K971448 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Jul 1997. https://www.510kdatabase.net/k965236/ 1997-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k965236-system-96-intra-aortic-balloon-pump-iabp-fda-510k.jpg K965236 - SYSTEM 96 INTRA-AORTIC BALLOON PUMP (IABP) K965236 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Jul 1997. https://www.510kdatabase.net/k971254/ 1997-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k971254-transend-ex-platinum-guidewire-fda-510k.jpg K971254 - TRANSEND EX PLATINUM GUIDEWIRE K971254 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Jul 1997. https://www.510kdatabase.net/k971328/ 1997-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k971328-olympus-cd-6c-1-coagulation-electrode-fda-510k.jpg K971328 - OLYMPUS CD-6C-1 COAGULATION ELECTRODE K971328 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus America, Inc.. Cleared Jul 1997. https://www.510kdatabase.net/k971861/ 1997-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k971861-ultrasonic-hand-instruments-fda-510k.jpg K971861 - ULTRASONIC HAND INSTRUMENTS K971861 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Jul 1997. https://www.510kdatabase.net/k965147/ 1997-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k965147-biliary-stent-biliary-stent-system-fda-510k.jpg K965147 - BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS K965147 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Jun 1997. https://www.510kdatabase.net/k972234/ 1997-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k972234-rct-gel-root-canal-therapy-gel-fda-510k.jpg K972234 - RCT GEL ROOT CANAL THERAPY GEL K972234 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jun 1997. https://www.510kdatabase.net/k963160/ 1997-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k963160-hx-56-1-endoscopic-clipping-device-fda-510k.jpg K963160 - HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE K963160 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus America, Inc.. Cleared Jun 1997. https://www.510kdatabase.net/k971188/ 1997-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k971188-smith-nephew-images-endoscopes-and-fda-510k.jpg K971188 - SMITH & NEPHEW IMAGES ENDOSCOPES AND ACCESSORIS/SEMI-RIGID AND FLEXIBLE MANUAL INSTRUMENTS K971188 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jun 1997. https://www.510kdatabase.net/k971282/ 1997-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k971282-anchorlok-and-anchorlok-rl-soft-tissue-fda-510k.jpg K971282 - ANCHORLOK AND ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM K971282 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jun 1997. https://www.510kdatabase.net/k971307/ 1997-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k971307-amsco-surgical-table-fda-510k.jpg K971307 - AMSCO SURGICAL TABLE K971307 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: STERIS Corporation. Cleared Jun 1997. https://www.510kdatabase.net/k971602/ 1997-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k971602-array-systems-rheumatoid-factor-rfmpe-fda-510k.jpg K971602 - ARRAY SYSTEMS RHEUMATOID FACTOR (RFMPE) REAGENT K971602 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jun 1997. https://www.510kdatabase.net/k971676/ 1997-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k971676-limited-reuse-endoscopic-blades-fda-510k.jpg K971676 - LIMITED REUSE ENDOSCOPIC BLADES K971676 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jun 1997. https://www.510kdatabase.net/k971682/ 1997-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k971682-j-fx-cerclage-system-fda-510k.jpg K971682 - J-FX CERCLAGE SYSTEM K971682 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jun 1997. https://www.510kdatabase.net/k971778/ 1997-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k971778-osteo-small-and-mini-bone-screws-fda-510k.jpg K971778 - OSTEO SMALL AND MINI BONE SCREWS K971778 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Jun 1997. https://www.510kdatabase.net/k964969/ 1997-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k964969-signa-sp-crown-coils-numbers-1-through-3-fda-510k.jpg K964969 - SIGNA SP CROWN COILS (NUMBERS 1 THROUGH 3) K964969 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Jun 1997. https://www.510kdatabase.net/k964923/ 1997-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k964923-codman-lumbar-drainage-catheter-kit-fda-510k.jpg K964923 - CODMAN LUMBAR DRAINAGE CATHETER KIT K964923 is a FDA 510(k) cleared neurology medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jun 1997. https://www.510kdatabase.net/k970285/ 1997-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k970285-aesuclap-socon-spinal-system-fda-510k.jpg K970285 - AESUCLAP SOCON SPINAL SYSTEM K970285 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aesculap, Inc.. Cleared Jun 1997. https://www.510kdatabase.net/k971139/ 1997-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k971139-bone-anchor-system-for-soft-tissue-fda-510k.jpg K971139 - BONE ANCHOR SYSTEM FOR SOFT TISSUE SUPPORT K971139 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Boston Scientific Corp. Cleared Jun 1997. https://www.510kdatabase.net/k971596/ 1997-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k971596-emit-ii-opiates-3002000-assay-fda-510k.jpg K971596 - EMIT II OPIATES 300/2000 ASSAY K971596 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Jun 1997. https://www.510kdatabase.net/k971600/ 1997-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k971600-emit-calibrator-b-level-1-cutoffemit-fda-510k.jpg K971600 - EMIT CALIBRATOR B LEVEL 1 (CUTOFF)/EMIT CALIBRATOR B LEVEL 2 (HIGH) K971600 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Jun 1997. https://www.510kdatabase.net/k963546/ 1997-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k963546-smf-titanium-ti-alloy-bone-screws-fda-510k.jpg K963546 - SMF TITANIUM (TI) ALLOY BONE SCREWS K963546 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Jun 1997. https://www.510kdatabase.net/k964595/ 1997-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k964595-opus-psa-test-system-fda-510k.jpg K964595 - OPUS PSA TEST SYSTEM K964595 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Jun 1997. https://www.510kdatabase.net/k970551/ 1997-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k970551-quanta-lite-b2gpi-igg-fda-510k.jpg K970551 - QUANTA LITE B2GPI IGG K970551 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Jun 1997. https://www.510kdatabase.net/k971987/ 1997-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k971987-synthes-usa-synthes-mini-external-fda-510k.jpg K971987 - SYNTHES (USA) [SYNTHES] MINI EXTERNAL FIXATOR K971987 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Jun 1997. https://www.510kdatabase.net/k972174/ 1997-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k972174-lyphochek-remedi-control-fda-510k.jpg K972174 - LYPHOCHEK REMEDI CONTROL K972174 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bio-Rad. Cleared Jun 1997. https://www.510kdatabase.net/k972214/ 1997-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k972214-roche-serum-control-normal-human-roche-fda-510k.jpg K972214 - ROCHE SERUM CONTROL NORMAL (HUMAN), ROCHE SERUM CONTROL PATHOLOGICAL (HUMAN) K972214 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jun 1997. https://www.510kdatabase.net/k972232/ 1997-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k972232-abbott-axsym-folate-fda-510k.jpg K972232 - ABBOTT AXSYM FOLATE K972232 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1997. https://www.510kdatabase.net/k964688/ 1997-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k964688-long-medium-palmaz-schatz-balloon-fda-510k.jpg K964688 - LONG MEDIUM PALMAZ-SCHATZ BALLOON EXPANDABLE STENT K964688 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Jun 1997. https://www.510kdatabase.net/k971055/ 1997-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k971055-diffusion-weighted-mr-imaging-magnetom-fda-510k.jpg K971055 - DIFFUSION WEIGHTED MR IMAGING /MAGNETOM VISION K971055 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 1997. https://www.510kdatabase.net/k971614/ 1997-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k971614-quanta-lite-rf-igm-fda-510k.jpg K971614 - QUANTA LITE RF IGM K971614 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Jun 1997. https://www.510kdatabase.net/k964650/ 1997-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k964650-tcp-coated-porocoat-aml-femoral-hip-fda-510k.jpg K964650 - TCP-COATED POROCOAT AML FEMORAL HIP PROSTHESIS K964650 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jun 1997. https://www.510kdatabase.net/k971010/ 1997-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k971010-peripheral-transluminal-angioplasty-fda-510k.jpg K971010 - PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETERS K971010 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Jun 1997. https://www.510kdatabase.net/k971725/ 1997-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k971725-opus-progesterone-fda-510k.jpg K971725 - OPUS PROGESTERONE K971725 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Jun 1997. https://www.510kdatabase.net/k971978/ 1997-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k971978-graft-harvesting-sawblades-fda-510k.jpg K971978 - GRAFT HARVESTING SAWBLADES K971978 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jun 1997. https://www.510kdatabase.net/k971379/ 1997-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k971379-tinaquant-rheumatoid-factor-assay-fda-510k.jpg K971379 - TINAQUANT RHEUMATOID FACTOR ASSAY K971379 is a FDA 510(k) cleared immunology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jun 1997. https://www.510kdatabase.net/k964368/ 1997-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k964368-elecsys-cea-assay-fda-510k.jpg K964368 - ELECSYS CEA ASSAY K964368 is a FDA 510(k) cleared immunology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jun 1997. https://www.510kdatabase.net/k971902/ 1997-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k971902-roche-unimate-hdl-direct-reagent-roche-fda-510k.jpg K971902 - ROCHE UNIMATE HDL DIRECT REAGENT, ROCHE CALIBRATOR HDL DIRECT K971902 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jun 1997. https://www.510kdatabase.net/k971952/ 1997-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k971952-lyphochek-hypertension-markers-control-fda-510k.jpg K971952 - LYPHOCHEK HYPERTENSION MARKERS CONTROL (CAT. NO. 600) K971952 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Jun 1997. https://www.510kdatabase.net/k971054/ 1997-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k971054-osteo-ct-for-the-somatom-ar-family-and-fda-510k.jpg K971054 - OSTEO CT FOR THE SOMATOM AR FAMILY AND PLUS 4 CT SYSTEMS K971054 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 1997. https://www.510kdatabase.net/k971253/ 1997-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k971253-various-arthroscopes-endoscopic-blades-fda-510k.jpg K971253 - VARIOUS ARTHROSCOPES, ENDOSCOPIC BLADES, MANUAL INSTRUMENTS K971253 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jun 1997. https://www.510kdatabase.net/k961711/ 1997-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k961711-aspisafe-gastric-tube-fda-510k.jpg K961711 - ASPISAFE GASTRIC TUBE K961711 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Jun 1997. https://www.510kdatabase.net/k963612/ 1997-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k963612-duration-stabilized-uhmwpe-fda-510k.jpg K963612 - DURATION STABILIZED UHMWPE K963612 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jun 1997. https://www.510kdatabase.net/k964842/ 1997-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k964842-immage-immunochemistry-system-fda-510k.jpg K964842 - IMMAGE IMMUNOCHEMISTRY SYSTEM COMPLEMENTC3 (C3) AND COMPLEMENTC4 (C4) REAGENT K964842 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jun 1997. https://www.510kdatabase.net/k965173/ 1997-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k965173-duration-stabilized-uhmwpe-knee-fda-510k.jpg K965173 - DURATION STABILIZED UHMWPE KNEE COMPONENTS K965173 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jun 1997. https://www.510kdatabase.net/k971505/ 1997-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k971505-synchron-systems-cholesterol-chol-fda-510k.jpg K971505 - SYNCHRON SYSTEMS CHOLESTEROL (CHOL) REAGENT K971505 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jun 1997. https://www.510kdatabase.net/k971817/ 1997-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k971817-olympus-ck-mb-reagent-fda-510k.jpg K971817 - OLYMPUS CK-MB REAGENT K971817 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus America, Inc.. Cleared Jun 1997. https://www.510kdatabase.net/k971954/ 1997-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k971954-liquichek-urine-chemistry-control-fda-510k.jpg K971954 - LIQUICHEK URINE CHEMISTRY CONTROL (CAT.NO. 397,398) K971954 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Jun 1997. https://www.510kdatabase.net/k970946/ 1997-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k970946-medline-y-type-turbladder-irrigation-set-fda-510k.jpg K970946 - MEDLINE Y-TYPE TUR/BLADDER IRRIGATION SET K970946 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medline Industries, Inc.. Cleared Jun 1997. https://www.510kdatabase.net/k970896/ 1997-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k970896-mitek-35-mm-panalok-wedge-absorbable-fda-510k.jpg K970896 - MITEK 3.5 MM PANALOK WEDGE ABSORBABLE SUTURE ANCHOR SYSTEM K970896 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ethicon, Inc.. Cleared Jun 1997. https://www.510kdatabase.net/k970929/ 1997-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k970929-depuy-low-profile-bone-screw-fda-510k.jpg K970929 - DEPUY LOW PROFILE BONE SCREW K970929 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jun 1997. https://www.510kdatabase.net/k971701/ 1997-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k971701-continu-flo-solution-set-fda-510k.jpg K971701 - CONTINU-FLO SOLUTION SET K971701 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jun 1997. https://www.510kdatabase.net/k964067/ 1997-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k964067-gore-irrigation-set-fda-510k.jpg K964067 - GORE IRRIGATION SET K964067 is a FDA 510(k) cleared general hospital medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Jun 1997. https://www.510kdatabase.net/k970852/ 1997-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k970852-magnetom-project-024-system-numaris-35-fda-510k.jpg K970852 - MAGNETOM PROJECT 024 SYSTEM (NUMARIS 3.5 SOFTWARE) K970852 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 1997. https://www.510kdatabase.net/k971135/ 1997-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k971135-magellan-intramedullary-femoral-nail-fda-510k.jpg K971135 - MAGELLAN INTRAMEDULLARY FEMORAL NAIL SYSTEM K971135 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jun 1997. https://www.510kdatabase.net/k963018/ 1997-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k963018-bio-rad-serum-proteins-by-capillary-fda-510k.jpg K963018 - BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESIS K963018 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Jun 1997. https://www.510kdatabase.net/k965062/ 1997-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k965062-siemens-sc9000sc9015-multigas-and-fda-510k.jpg K965062 - SIEMENS SC9000/SC9015 MULTIGAS AND MULTIGAS+ MODULES K965062 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 1997. https://www.510kdatabase.net/k970905/ 1997-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k970905-synchron-cx-systems-lipase-lipa-reagent-fda-510k.jpg K970905 - SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENT K970905 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jun 1997. https://www.510kdatabase.net/k971603/ 1997-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k971603-sterile-sureflex-files-and-instruments-fda-510k.jpg K971603 - STERILE SUREFLEX FILES AND INSTRUMENTS K971603 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jun 1997. https://www.510kdatabase.net/k970957/ 1997-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k970957-osteonics-restoration-acetabular-ring-fda-510k.jpg K970957 - OSTEONICS RESTORATION ACETABULAR RING K970957 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Jun 1997. https://www.510kdatabase.net/k971201/ 1997-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k971201-auto-suture-ilm-kit-fda-510k.jpg K971201 - AUTO SUTURE* ILM** KIT K971201 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Jun 1997. https://www.510kdatabase.net/k971283/ 1997-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k971283-synchron-systems-cal-5-plus-fda-510k.jpg K971283 - SYNCHRON SYSTEMS CAL 5 PLUS K971283 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jun 1997. https://www.510kdatabase.net/k971506/ 1997-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k971506-synchron-systems-alcohol-alc-reagent-fda-510k.jpg K971506 - SYNCHRON SYSTEMS ALCOHOL (ALC) REAGENT, SYNCHRON SYSTEMS ALCOHOL CALIBRATOR K971506 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jun 1997. https://www.510kdatabase.net/k971606/ 1997-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k971606-sterile-flexofile-files-and-instruments-fda-510k.jpg K971606 - STERILE FLEXOFILE FILES AND INSTRUMENTS K971606 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jun 1997. https://www.510kdatabase.net/k971788/ 1997-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k971788-synchron-systems-rheumatoid-factor-rf-fda-510k.jpg K971788 - SYNCHRON SYSTEMS RHEUMATOID FACTOR (RF) REAGENT, SYNCHRON CX SYSTEMS RF CALIBRATOR K971788 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jun 1997. https://www.510kdatabase.net/k964929/ 1997-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k964929-peripherally-inserted-central-catheter-fda-510k.jpg K964929 - PERIPHERALLY INSERTED CENTRAL CATHETER K964929 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Jun 1997. https://www.510kdatabase.net/k964986/ 1997-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k964986-quanta-lite-iga-gliadin-elisa-fda-510k.jpg K964986 - QUANTA LITE IGA GLIADIN ELISA K964986 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Jun 1997. https://www.510kdatabase.net/k971085/ 1997-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k971085-soft-tip-multi-lumen-central-venous-fda-510k.jpg K971085 - SOFT TIP MULTI-LUMEN CENTRAL VENOUS CATHETER K971085 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Jun 1997. https://www.510kdatabase.net/k971833/ 1997-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k971833-elecsys-ferritin-fda-510k.jpg K971833 - ELECSYS FERRITIN K971833 is a FDA 510(k) cleared immunology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jun 1997. https://www.510kdatabase.net/k964985/ 1997-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k964985-quanta-lite-igg-gliadin-elisa-fda-510k.jpg K964985 - QUANTA LITE IGG GLIADIN ELISA K964985 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared May 1997. https://www.510kdatabase.net/k971691/ 1997-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k971691-liquichek-urine-toxicology-control-fda-510k.jpg K971691 - LIQUICHEK URINE TOXICOLOGY CONTROL - LEVEL S1, S2, S3 K971691 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bio-Rad. Cleared May 1997. https://www.510kdatabase.net/k962142/ 1997-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k962142-sonoline-versa-555-diagnostic-fda-510k.jpg K962142 - SONOLINE VERSA 555 DIAGNOSTIC ULTRASOUND SYSTEM K962142 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 1997. https://www.510kdatabase.net/k970797/ 1997-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k970797-olympus-psd-20-electrosurgical-system-fda-510k.jpg K970797 - OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM AND ACCESSORIES K970797 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Olympus America, Inc.. Cleared May 1997. https://www.510kdatabase.net/k970842/ 1997-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k970842-cordis-endeavor-infusion-catheter-fda-510k.jpg K970842 - Cordis Endeavor Infusion Catheter K970842 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared May 1997. https://www.510kdatabase.net/k971034/ 1997-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k971034-usci-mainstay-guiding-catheter-fda-510k.jpg K971034 - USCI MAINSTAY GUIDING CATHETER K971034 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 1997. https://www.510kdatabase.net/k971544/ 1997-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k971544-synthes-usa-compact-air-drive-ii-cad-ii-fda-510k.jpg K971544 - SYNTHES (USA) COMPACT AIR DRIVE II (CAD II) K971544 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared May 1997. https://www.510kdatabase.net/k971312/ 1997-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k971312-immulite-pyrilinks-d-fda-510k.jpg K971312 - IMMULITE PYRILINKS-D K971312 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared May 1997. https://www.510kdatabase.net/k971777/ 1997-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k971777-quantex-aso-crp-rf-control-fda-510k.jpg K971777 - QUANTEX ASO-CRP-RF CONTROL K971777 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared May 1997. https://www.510kdatabase.net/k964251/ 1997-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k964251-occlusion-clamp-device-fda-510k.jpg K964251 - OCCLUSION CLAMP** DEVICE K964251 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared May 1997. https://www.510kdatabase.net/k971333/ 1997-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k971333-synchron-systems-alkaline-phosphatase-fda-510k.jpg K971333 - SYNCHRON SYSTEMS ALKALINE PHOSPHATASE REAGENT, CHOLINESTERASE REAGENT, GAMMA-GLUTAMYL TRANSFERASE REAGENT, LACTATE DEHYD K971333 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared May 1997. https://www.510kdatabase.net/k970758/ 1997-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k970758-duracon-extra-small-stabilizer-tibial-fda-510k.jpg K970758 - DURACON EXTRA-SMALL STABILIZER TIBIAL INSERT & BASEPLATE K970758 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared May 1997. https://www.510kdatabase.net/k971155/ 1997-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k971155-memoreg-fda-510k.jpg K971155 - MEMOREG K971155 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared May 1997. https://www.510kdatabase.net/k971422/ 1997-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k971422-osteonics-acetabular-wedge-system-fda-510k.jpg K971422 - OSTEONICS ACETABULAR WEDGE SYSTEM K971422 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared May 1997. https://www.510kdatabase.net/k963254/ 1997-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k963254-symphony-nitinol-stent-transhepatic-fda-510k.jpg K963254 - SYMPHONY NITINOL STENT TRANSHEPATIC BILIARY SYSTEM K963254 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared May 1997. https://www.510kdatabase.net/k964329/ 1997-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k964329-unipolar-hook-electrode-5mm-fda-510k.jpg K964329 - UNIPOLAR HOOK ELECTRODE (5MM .340MM)/UNIPOLAR HOOK ELECTRODE (5MM. 420MM) K964329 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared May 1997. https://www.510kdatabase.net/k964978/ 1997-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k964978-vital-statistics-system-o-cath-accessory-fda-510k.jpg K964978 - VITAL STATISTICS SYSTEM (O-CATH ACCESSORY) K964978 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Quinton, Inc.. Cleared May 1997. https://www.510kdatabase.net/k970883/ 1997-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k970883-cedia-digoxin-ii-fda-510k.jpg K970883 - CEDIA DIGOXIN II K970883 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared May 1997. https://www.510kdatabase.net/k970919/ 1997-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k970919-synchron-cx-systems-uric-acid-uric-fda-510k.jpg K970919 - SYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENT K970919 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared May 1997. https://www.510kdatabase.net/k962899/ 1997-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k962899-ultraflex-diamond-fda-510k.jpg K962899 - ULTRAFLEX DIAMOND K962899 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared May 1997. https://www.510kdatabase.net/k970604/ 1997-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k970604-viewpoint-30-software-fda-510k.jpg K970604 - VIEWPOINT - 3.0 SOFTWARE K970604 is a FDA 510(k) cleared neurology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared May 1997. https://www.510kdatabase.net/k970645/ 1997-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k970645-bc-thrombin-reagent-fda-510k.jpg K970645 - BC THROMBIN REAGENT K970645 is a FDA 510(k) cleared hematology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared May 1997. https://www.510kdatabase.net/k971177/ 1997-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k971177-immulite-vitamin-b12-lkvb1lkvb5-fda-510k.jpg K971177 - IMMULITE VITAMIN B12 (LKVB1,LKVB5) K971177 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared May 1997. https://www.510kdatabase.net/k971203/ 1997-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k971203-synchron-systems-thyroxine-reagent-fda-510k.jpg K971203 - SYNCHRON SYSTEMS THYROXINE REAGENT K971203 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared May 1997. https://www.510kdatabase.net/k964832/ 1997-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k964832-hewlett-packard-centralvue-software-fda-510k.jpg K964832 - HEWLETT-PACKARD CENTRALVUE SOFTWARE K964832 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared May 1997. https://www.510kdatabase.net/k971390/ 1997-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k971390-quantum-3080sp-surgical-table-fda-510k.jpg K971390 - QUANTUM 3080SP SURGICAL TABLE K971390 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: STERIS Corporation. Cleared May 1997. https://www.510kdatabase.net/k970881/ 1997-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k970881-cedia-digoxin-fda-510k.jpg K970881 - CEDIA DIGOXIN K970881 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared May 1997. https://www.510kdatabase.net/k971452/ 1997-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k971452-multix-toppro-radiographic-x-ray-table-fda-510k.jpg K971452 - MULTIX TOP/PRO RADIOGRAPHIC X-RAY TABLE K971452 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 1997. https://www.510kdatabase.net/k971208/ 1997-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k971208-medline-industries-inc-orthopedic-fda-510k.jpg K971208 - MEDLINE INDUSTRIES, INC. ORTHOPEDIC TRAYS/KITS/PACKS K971208 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medline Industries, Inc.. Cleared May 1997. https://www.510kdatabase.net/k961608/ 1997-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k961608-synthes-usa-polypin-fda-510k.jpg K961608 - SYNTHES (U.S.A.) POLYPIN K961608 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared May 1997. https://www.510kdatabase.net/k964781/ 1997-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k964781-immage-immunochemistry-system-fda-510k.jpg K964781 - IMMAGE IMMUNOCHEMISTRY SYSTEM PREALBUMIN (PAB) REAGENT K964781 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared May 1997. https://www.510kdatabase.net/k965103/ 1997-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k965103-winmax-software-systems-fda-510k.jpg K965103 - WINMAX SOFTWARE SYSTEMS K965103 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared May 1997. https://www.510kdatabase.net/k970779/ 1997-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k970779-osteonics-tibial-tray-screw-hole-plugs-fda-510k.jpg K970779 - OSTEONICS TIBIAL TRAY SCREW HOLE PLUGS K970779 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared May 1997. https://www.510kdatabase.net/k964069/ 1997-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k964069-dsbas-option-the-mammomat-3000-fda-510k.jpg K964069 - DSBAS OPTION THE MAMMOMAT 3000 MAMMOGRAPHY X-RAY SYSTEM K964069 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 1997. https://www.510kdatabase.net/k970884/ 1997-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k970884-resolut-regenerative-material-fda-510k.jpg K970884 - RESOLUT REGENERATIVE MATERIAL K970884 is a FDA 510(k) cleared dental medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared May 1997. https://www.510kdatabase.net/k971287/ 1997-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k971287-synchron-systems-drug-calibration-3-plus-fda-510k.jpg K971287 - SYNCHRON SYSTEMS DRUG CALIBRATION 3 PLUS K971287 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared May 1997. https://www.510kdatabase.net/k963562/ 1997-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k963562-wright-plaster-of-paris-pellets-fda-510k.jpg K963562 - WRIGHT PLASTER OF PARIS PELLETS K963562 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared May 1997. https://www.510kdatabase.net/k963962/ 1997-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k963962-vista-brite-tip-catheters-fda-510k.jpg K963962 - VISTA BRITE TIP CATHETERS K963962 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared May 1997. https://www.510kdatabase.net/k955622/ 1997-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k955622-automix-plus-33-micromix-compounding-fda-510k.jpg K955622 - AUTOMIX PLUS, 3+3, MICROMIX COMPOUNDING SYSTEM K955622 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared May 1997. https://www.510kdatabase.net/k955816/ 1997-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k955816-vigilance-continuous-cardiac-fda-510k.jpg K955816 - VIGILANCE CONTINUOUS CARDIAC OUTPUT/OXIMETRY (CCO/SVO2) MONITOR K955816 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared May 1997. https://www.510kdatabase.net/k964114/ 1997-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k964114-depuy-opti-con-and-e-z-shield-systems-fda-510k.jpg K964114 - DEPUY OPTI-CON AND E-Z SHIELD SYSTEMS K964114 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Depuy, Inc.. Cleared May 1997. https://www.510kdatabase.net/k970368/ 1997-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k970368-sc9000sc9015-medical-information-bus-fda-510k.jpg K970368 - SC9000/SC9015 MEDICAL INFORMATION BUS (MIS) PROTOCOL CONVERTER K970368 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 1997. https://www.510kdatabase.net/k970463/ 1997-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k970463-capiox-e-hollow-fiber-oxygenator-with-fda-510k.jpg K970463 - CAPIOX E HOLLOW FIBER OXYGENATOR WITH INTEGRATED HEAT EXCHANGER/ARTERIAL RESERVOIR K970463 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared May 1997. https://www.510kdatabase.net/k970620/ 1997-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k970620-cordis-opta5-pta-balloon-catheter-fda-510k.jpg K970620 - CORDIS OPTA5 PTA BALLOON CATHETER K970620 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared May 1997. https://www.510kdatabase.net/k970848/ 1997-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k970848-siloc-system-fda-510k.jpg K970848 - SILOC SYSTEM K970848 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared May 1997. https://www.510kdatabase.net/k960068/ 1997-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k960068-sh-1-surgical-holder-for-telescope-fda-510k.jpg K960068 - SH-1 SURGICAL HOLDER FOR TELESCOPE K960068 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus America, Inc.. Cleared May 1997. https://www.510kdatabase.net/k970431/ 1997-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k970431-behring-coagulation-system-fda-510k.jpg K970431 - BEHRING COAGULATION SYSTEM K970431 is a FDA 510(k) cleared hematology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared May 1997. https://www.510kdatabase.net/k970863/ 1997-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k970863-modified-ussc-polysorb-suture-fda-510k.jpg K970863 - MODIFIED USSC* POLYSORB SUTURE K970863 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared May 1997. https://www.510kdatabase.net/k963782/ 1997-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k963782-bard-memotherm-transhepatic-biliary-fda-510k.jpg K963782 - BARD MEMOTHERM TRANSHEPATIC BILIARY ENDOPROSTHESIS K963782 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 1997. https://www.510kdatabase.net/k970379/ 1997-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k970379-channel-balloon-catheter-fda-510k.jpg K970379 - CHANNEL BALLOON CATHETER K970379 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared May 1997. https://www.510kdatabase.net/k970500/ 1997-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k970500-3m-sustel-dental-system-fda-510k.jpg K970500 - 3M SUSTEL DENTAL SYSTEM K970500 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Apr 1997. https://www.510kdatabase.net/k970501/ 1997-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k970501-pegged-acetabular-component-fda-510k.jpg K970501 - PEGGED ACETABULAR COMPONENT K970501 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Apr 1997. https://www.510kdatabase.net/k970549/ 1997-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k970549-titanium-alloy-bone-screws-fda-510k.jpg K970549 - TITANIUM ALLOY BONE SCREWS K970549 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aesculap, Inc.. Cleared Apr 1997. https://www.510kdatabase.net/k964695/ 1997-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k964695-immage-immunochemistry-system-albumin-fda-510k.jpg K964695 - IMMAGE IMMUNOCHEMISTRY SYSTEM ALBUMIN (ALB) REAGENT K964695 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Apr 1997. https://www.510kdatabase.net/k970345/ 1997-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k970345-alignment-instrument-fda-510k.jpg K970345 - ALIGNMENT INSTRUMENT K970345 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Apr 1997. https://www.510kdatabase.net/k963916/ 1997-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k963916-immulite-cannabinoids-fda-510k.jpg K963916 - IMMULITE CANNABINOIDS K963916 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Apr 1997. https://www.510kdatabase.net/k964762/ 1997-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k964762-immage-immunochemistry-system-fda-510k.jpg K964762 - IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENT K964762 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Apr 1997. https://www.510kdatabase.net/k964766/ 1997-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k964766-immage-immunochemistry-system-alpha-1-fda-510k.jpg K964766 - IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ANTITRYPSIN (AAT) K964766 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Apr 1997. https://www.510kdatabase.net/k970303/ 1997-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k970303-saturne-multileaf-collimator-fda-510k.jpg K970303 - SATURNE MULTILEAF COLLIMATOR K970303 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Apr 1997. https://www.510kdatabase.net/k970317/ 1997-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k970317-modified-e-pack-procedure-kit-fda-510k.jpg K970317 - MODIFIED E-PACK PROCEDURE KIT K970317 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Apr 1997. https://www.510kdatabase.net/k962882/ 1997-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k962882-sonoline-versa-pro-diagnostic-fda-510k.jpg K962882 - SONOLINE VERSA PRO DIAGNOSTIC ULTRASOUND SYSTEM K962882 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 1997. https://www.510kdatabase.net/k962936/ 1997-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k962936-immulite-toxoplasma-quantitative-igg-fda-510k.jpg K962936 - IMMULITE TOXOPLASMA QUANTITATIVE IGG K962936 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Apr 1997. https://www.510kdatabase.net/k970299/ 1997-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k970299-jupiter-pta-catheters-various-fda-510k.jpg K970299 - JUPITER PTA CATHETERS (VARIOUS) K970299 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Apr 1997. https://www.510kdatabase.net/k970392/ 1997-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k970392-cordis-avanticatheter-sheath-fda-510k.jpg K970392 - CORDIS AVANTI+CATHETER SHEATH INTRODUCER SYSTEM K970392 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Apr 1997. https://www.510kdatabase.net/k970697/ 1997-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k970697-osteonics-normalized-ad-acetabular-fda-510k.jpg K970697 - OSTEONICS NORMALIZED AD ACETABULAR COMPONENT SYSTEM K970697 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Apr 1997. https://www.510kdatabase.net/k962571/ 1997-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k962571-coaguchek-pst-system-fda-510k.jpg K962571 - COAGUCHEK PST SYSTEM K962571 is a FDA 510(k) cleared hematology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Apr 1997. https://www.510kdatabase.net/k964309/ 1997-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k964309-sonos-2000-sonos-2500-m2406-a-fda-510k.jpg K964309 - SONOS 2000, SONOS 2500 (M2406 A) K964309 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Apr 1997. https://www.510kdatabase.net/k970394/ 1997-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k970394-osteonics-normalized-ad-ha-acetabular-fda-510k.jpg K970394 - OSTEONICS NORMALIZED AD-HA ACETABULAR COMPONENT SYSTEM K970394 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Apr 1997. https://www.510kdatabase.net/k964281/ 1997-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k964281-aesculap-angled-neuroendoscopes-fda-510k.jpg K964281 - AESCULAP ANGLED NEUROENDOSCOPES K964281 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Apr 1997. https://www.510kdatabase.net/k965033/ 1997-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k965033-immage-immunochemistry-system-alpha-1-fda-510k.jpg K965033 - IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-MICROGLOBULIN (AI) REAGENT K965033 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Apr 1997. https://www.510kdatabase.net/k970314/ 1997-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k970314-synchron-lx-systems-apolipoprotein-fda-510k.jpg K970314 - SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS K970314 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Apr 1997. https://www.510kdatabase.net/k970734/ 1997-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k970734-siregragh-top-33-and-siregraph-top-40-fda-510k.jpg K970734 - SIREGRAGH T.O.P. 33 AND SIREGRAPH T.O.P. 40 UNIVERSAL FLUOROSCOPIC X-RAY SYSTEMS K970734 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 1997. https://www.510kdatabase.net/k963761/ 1997-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k963761-quartet-clinical-system-fda-510k.jpg K963761 - QUARTET CLINICAL SYSTEM K963761 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Apr 1997. https://www.510kdatabase.net/k965035/ 1997-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k965035-immage-immunochemistry-system-fda-510k.jpg K965035 - IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENT K965035 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Apr 1997. https://www.510kdatabase.net/k971210/ 1997-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k971210-synchron-systems-10-ngml-40-ngml-thc-fda-510k.jpg K971210 - SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLS K971210 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Apr 1997. https://www.510kdatabase.net/k962129/ 1997-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k962129-continuous-flush-device-fda-510k.jpg K962129 - CONTINUOUS FLUSH DEVICE K962129 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Apr 1997. https://www.510kdatabase.net/k970533/ 1997-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k970533-model-1100-cold-therapy-device-fda-510k.jpg K970533 - MODEL 1100 COLD THERAPY DEVICE K970533 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Apr 1997. https://www.510kdatabase.net/k964261/ 1997-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k964261-smf-stainless-steel-bone-screws-fda-510k.jpg K964261 - SMF STAINLESS STEEL BONE SCREWS K964261 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Apr 1997. https://www.510kdatabase.net/k970123/ 1997-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k970123-dentsply-cavitron-sps-scaler-system-fda-510k.jpg K970123 - DENTSPLY CAVITRON SPS SCALER SYSTEM K970123 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Apr 1997. https://www.510kdatabase.net/k970184/ 1997-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k970184-olympus-ues-20-electrosurgical-system-fda-510k.jpg K970184 - OLYMPUS UES-20 ELECTROSURGICAL SYSTEM AND ITS ASSOCIATED ACCESSORIES K970184 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Olympus America, Inc.. Cleared Apr 1997. https://www.510kdatabase.net/k970278/ 1997-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k970278-microvasive-gold-probe-fda-510k.jpg K970278 - MICROVASIVE GOLD PROBE K970278 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Apr 1997. https://www.510kdatabase.net/k970453/ 1997-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k970453-b-braun-medical-inc-transorbent-and-fda-510k.jpg K970453 - B. BRAUN MEDICAL INC. TRANSORBENT AND THINSITE BORDER DRESSING K970453 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Apr 1997. https://www.510kdatabase.net/k970563/ 1997-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k970563-olympus-na-10j-1-aspiration-needle-fda-510k.jpg K970563 - OLYMPUS NA-10J-1 ASPIRATION NEEDLE K970563 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus America, Inc.. Cleared Apr 1997. https://www.510kdatabase.net/k971051/ 1997-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k971051-immulite-thyroid-autoantibody-control-fda-510k.jpg K971051 - IMMULITE THYROID AUTOANTIBODY CONTROL MODULE K971051 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Apr 1997. https://www.510kdatabase.net/k970200/ 1997-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k970200-reliance-pf-femoral-stems-fda-510k.jpg K970200 - RELIANCE PF FEMORAL STEMS K970200 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Apr 1997. https://www.510kdatabase.net/k963918/ 1997-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k963918-immulite-cocaine-metabolite-fda-510k.jpg K963918 - IMMULITE COCAINE METABOLITE K963918 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Apr 1997. https://www.510kdatabase.net/k970088/ 1997-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k970088-riwo-drive-with-footswitchmotor-handle-fda-510k.jpg K970088 - RIWO DRIVE WITH FOOTSWITCH/MOTOR HANDLE, COOMPLETE,6000RPM/3000RPM/ROTARY BLADES AND ABRADERS SEE SECTION 1: K970088 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Apr 1997. https://www.510kdatabase.net/k970287/ 1997-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k970287-lumbar-puncture-kit-fda-510k.jpg K970287 - LUMBAR PUNCTURE KIT K970287 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Apr 1997. https://www.510kdatabase.net/k970154/ 1997-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k970154-kodak-ektasian-hg-film-ehg-15-fda-510k.jpg K970154 - KODAK EKTASIAN HG FILM (EHG-15) K970154 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Apr 1997. https://www.510kdatabase.net/k970342/ 1997-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k970342-cavitron-jet-with-sps-system-fda-510k.jpg K970342 - CAVITRON JET WITH SPS SYSTEM K970342 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Apr 1997. https://www.510kdatabase.net/k970606/ 1997-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k970606-computed-tomography-x-ray-system-fda-510k.jpg K970606 - COMPUTED TOMOGRAPHY X-RAY SYSTEM K970606 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Apr 1997. https://www.510kdatabase.net/k962627/ 1997-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k962627-clinical-phosphorus-spectroscopy-fda-510k.jpg K962627 - CLINICAL PHOSPHORUS SPECTROSCOPY OPTION/MAGNETOM VISION SYSTEM K962627 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 1997. https://www.510kdatabase.net/k962696/ 1997-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k962696-perifix-pediatric-epidural-kit-fda-510k.jpg K962696 - PERIFIX PEDIATRIC EPIDURAL KIT K962696 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Apr 1997. https://www.510kdatabase.net/k963855/ 1997-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k963855-12-ureteroscopesuretero-renoscopes-fda-510k.jpg K963855 - 12 URETEROSCOPES/URETERO-RENOSCOPES K963855 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Apr 1997. https://www.510kdatabase.net/k964970/ 1997-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k964970-biomet-bone-screw-fda-510k.jpg K964970 - BIOMET BONE SCREW K964970 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Apr 1997. https://www.510kdatabase.net/k961260/ 1997-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k961260-kirschner-sholders-with-titanium-fda-510k.jpg K961260 - KIRSCHNER SHOLDERS WITH TITANIUM PLASMA SPRAY K961260 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Apr 1997. https://www.510kdatabase.net/k963613/ 1997-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k963613-immulite-rubella-igg-fda-510k.jpg K963613 - IMMULITE RUBELLA IGG K963613 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Apr 1997. https://www.510kdatabase.net/k964038/ 1997-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k964038-charisma-f-charisma-creactive-solid-fda-510k.jpg K964038 - CHARISMA F, CHARISMA CREACTIVE, SOLID BOND, & ESTICID -20FG K964038 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Apr 1997. https://www.510kdatabase.net/k964654/ 1997-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k964654-becton-dickinson-blunt-plastic-cannula-fda-510k.jpg K964654 - BECTON DICKINSON BLUNT PLASTIC CANNULA K964654 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1997. https://www.510kdatabase.net/k970121/ 1997-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k970121-stone-dislodger-basket-fda-510k.jpg K970121 - STONE DISLODGER, BASKET K970121 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Apr 1997. https://www.510kdatabase.net/k970438/ 1997-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k970438-interlink-micro-infusion-manifold-fda-510k.jpg K970438 - INTERLINK MICRO-INFUSION MANIFOLD EXTENSION SETS K970438 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Apr 1997. https://www.510kdatabase.net/k970733/ 1997-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k970733-synthes-titanium-diastal-femoral-nail-fda-510k.jpg K970733 - SYNTHES TITANIUM DIASTAL FEMORAL NAIL (TI DFN) SYSTEM K970733 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Apr 1997. https://www.510kdatabase.net/k970984/ 1997-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k970984-the-elecsys-calcheck-progesterone-fda-510k.jpg K970984 - THE ELECSYS CALCHECK PROGESTERONE K970984 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Apr 1997. https://www.510kdatabase.net/k964853/ 1997-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k964853-intravia-container-empty-fda-510k.jpg K964853 - INTRAVIA CONTAINER, EMPTY K964853 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 1997. https://www.510kdatabase.net/k970053/ 1997-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k970053-ultratomerx-fda-510k.jpg K970053 - ULTRATOMERX K970053 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Mar 1997. https://www.510kdatabase.net/k970541/ 1997-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k970541-aesculap-modular-monopolar-electrodes-fda-510k.jpg K970541 - AESCULAP MODULAR MONOPOLAR ELECTRODES K970541 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Mar 1997. https://www.510kdatabase.net/k970737/ 1997-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k970737-b-d-ultra-fine-ii-short-31g-x-516-pen-fda-510k.jpg K970737 - B-D ULTRA-FINE II SHORT 31G X 5/16 PEN NEEDLE K970737 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1997. https://www.510kdatabase.net/k970433/ 1997-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k970433-aquasil-rigid-smart-wetting-impression-fda-510k.jpg K970433 - AQUASIL RIGID SMART WETTING IMPRESSION MATERIAL K970433 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Mar 1997. https://www.510kdatabase.net/k964024/ 1997-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k964024-depuy-motech-titanium-moss-miami-fda-510k.jpg K964024 - DEPUY MOTECH TITANIUM MOSS MIAMI SPINAL SYSTEM K964024 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Mar 1997. https://www.510kdatabase.net/k963203/ 1997-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k963203-bentley-quick-prime-hemoconcentrator-fda-510k.jpg K963203 - BENTLEY QUICK-PRIME HEMOCONCENTRATOR WITH DURAFLO TREATMENT K963203 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 1997. https://www.510kdatabase.net/k963325/ 1997-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k963325-synthes-titanium-ti-alloy-high-tibial-fda-510k.jpg K963325 - SYNTHES TITANIUM (TI) ALLOY HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM K963325 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Mar 1997. https://www.510kdatabase.net/k970036/ 1997-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k970036-fixation-pin-or-rod-fda-510k.jpg K970036 - FIXATION PIN OR ROD K970036 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Mar 1997. https://www.510kdatabase.net/k970052/ 1997-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k970052-extractorrx-fda-510k.jpg K970052 - EXTRACTORRX K970052 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Mar 1997. https://www.510kdatabase.net/k954301/ 1997-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k954301-abbott-cmv-total-antibody-eia-fda-510k.jpg K954301 - ABBOTT CMV TOTAL ANTIBODY EIA (MODIFICATION) K954301 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1997. https://www.510kdatabase.net/k963587/ 1997-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k963587-wright-plaster-of-paris-bone-void-fda-510k.jpg K963587 - WRIGHT PLASTER OF PARIS BONE VOID FILLER KIT (SUBJECT TO REVISION) K963587 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Mar 1997. https://www.510kdatabase.net/k964257/ 1997-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k964257-immage-immunochemistry-system-alpha-1-fda-510k.jpg K964257 - IMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-ACID GLYCOPROTEIN (AAG) REAGENT K964257 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Mar 1997. https://www.510kdatabase.net/k964841/ 1997-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k964841-elecsys-progesterone-assay-fda-510k.jpg K964841 - ELECSYS PROGESTERONE ASSAY K964841 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Mar 1997. https://www.510kdatabase.net/k965186/ 1997-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k965186-axsym-b12-fda-510k.jpg K965186 - AXSYM B12 K965186 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1997. https://www.510kdatabase.net/k962010/ 1997-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k962010-epi-scope-option-for-q-series-ct-systems-fda-510k.jpg K962010 - EPI-SCOPE OPTION FOR Q SERIES CT SYSTEMS K962010 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Mar 1997. https://www.510kdatabase.net/k970247/ 1997-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k970247-smith-nephew-images-arthroscopeent-fda-510k.jpg K970247 - SMITH & NEPHEW IMAGES ARTHROSCOPE/ENT ENDOSCOPE K970247 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Mar 1997. https://www.510kdatabase.net/k962141/ 1997-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k962141-volume-control-syringe-model-vcd-syr-10-fda-510k.jpg K962141 - VOLUME CONTROL SYRINGE MODEL VCD-SYR-10 K962141 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Mar 1997. https://www.510kdatabase.net/k963706/ 1997-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k963706-philips-sono-diagnost-800-fda-510k.jpg K963706 - PHILIPS SONO DIAGNOST 800 K963706 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Mar 1997. https://www.510kdatabase.net/k963976/ 1997-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k963976-immunochemistry-sys-urine-transferrin-fda-510k.jpg K963976 - IMMUNOCHEMISTRY SYS URINE TRANSFERRIN REAGENT K963976 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Mar 1997. https://www.510kdatabase.net/k965085/ 1997-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k965085-enzymun-test-psa-fda-510k.jpg K965085 - ENZYMUN-TEST PSA K965085 is a FDA 510(k) cleared immunology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Mar 1997. https://www.510kdatabase.net/k965163/ 1997-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k965163-cuttersil-comfort-fda-510k.jpg K965163 - CUTTERSIL COMFORT K965163 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Mar 1997. https://www.510kdatabase.net/k965165/ 1997-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k965165-cuttersil-comfort-hardener-fda-510k.jpg K965165 - CUTTERSIL COMFORT HARDENER K965165 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Mar 1997. https://www.510kdatabase.net/k962628/ 1997-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k962628-moss-miami-spinal-system-fda-510k.jpg K962628 - MOSS MIAMI SPINAL SYSTEM K962628 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Mar 1997. https://www.510kdatabase.net/k964889/ 1997-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k964889-elecsys-testosterone-assay-fda-510k.jpg K964889 - ELECSYS TESTOSTERONE ASSAY K964889 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Mar 1997. https://www.510kdatabase.net/k965251/ 1997-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k965251-medtronic-algoline-intraspinal-fda-510k.jpg K965251 - MEDTRONIC ALGOLINE INTRASPINAL CATHETER SYSTEM K965251 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medtronic Vascular. Cleared Mar 1997. https://www.510kdatabase.net/k970151/ 1997-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k970151-interceptre-laparoscopic-instruments-fda-510k.jpg K970151 - INTERCEPTRE LAPAROSCOPIC INSTRUMENTS K970151 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Mar 1997. https://www.510kdatabase.net/k970359/ 1997-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k970359-combiprot-emergency-enfusion-device-fda-510k.jpg K970359 - COMBIPROT EMERGENCY ENFUSION DEVICE K970359 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Mar 1997. https://www.510kdatabase.net/k961021/ 1997-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k961021-kirschner-knee-modified-fda-510k.jpg K961021 - KIRSCHNER KNEE MODIFIED K961021 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Mar 1997. https://www.510kdatabase.net/k964029/ 1997-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k964029-emergency-relief-kit-system-fda-510k.jpg K964029 - EMERGENCY RELIEF KIT SYSTEM K964029 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 1997. https://www.510kdatabase.net/k964416/ 1997-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k964416-synthes-usauniversal-spinal-parellel-fda-510k.jpg K964416 - SYNTHES (U.S.A.)UNIVERSAL SPINAL PARELLEL CONNECTOR THE UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM K964416 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Mar 1997. https://www.510kdatabase.net/k964987/ 1997-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k964987-datascope-percor-stat-dl-95-fr-25-and-fda-510k.jpg K964987 - DATASCOPE PERCOR STAT - DL 9.5 FR. 25 AND 40CC INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION AND PERCOR STAT -0 K964987 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Mar 1997. https://www.510kdatabase.net/k970034/ 1997-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k970034-sd-800-sonodiagnost-ultrasound-imaging-fda-510k.jpg K970034 - SD 800 SONODIAGNOST ULTRASOUND IMAGING SYSTEM K970034 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Mar 1997. https://www.510kdatabase.net/k965145/ 1997-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k965145-depuy-motech-moss-miami-spinal-system-fda-510k.jpg K965145 - DEPUY MOTECH MOSS MIAMI SPINAL SYSTEM K965145 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Mar 1997. https://www.510kdatabase.net/k965164/ 1997-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k965164-howmedica-modular-replacement-system-fda-510k.jpg K965164 - HOWMEDICA MODULAR REPLACEMENT SYSTEM-PROXIMAL FEMUR K965164 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Mar 1997. https://www.510kdatabase.net/k965175/ 1997-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k965175-howmedica-mainstay-anchor-fda-510k.jpg K965175 - HOWMEDICA MAINSTAY ANCHOR K965175 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Mar 1997. https://www.510kdatabase.net/k970097/ 1997-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k970097-proximal-femoral-nail-pfn-system-fda-510k.jpg K970097 - PROXIMAL FEMORAL NAIL (PFN) SYSTEM K970097 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Mar 1997. https://www.510kdatabase.net/k955179/ 1997-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k955179-contrast-media-set-fda-510k.jpg K955179 - CONTRAST MEDIA SET K955179 is a FDA 510(k) cleared radiology medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Mar 1997. https://www.510kdatabase.net/k965004/ 1997-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k965004-care-vision-for-the-somatom-plus-4-ct-fda-510k.jpg K965004 - C.A.R.E. VISION FOR THE SOMATOM PLUS 4 CT SCANNER K965004 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 1997. https://www.510kdatabase.net/k965107/ 1997-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k965107-medline-admission-kits-fda-510k.jpg K965107 - MEDLINE ADMISSION KITS K965107 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Mar 1997. https://www.510kdatabase.net/k965211/ 1997-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k965211-vista-brite-tip-catheters-fda-510k.jpg K965211 - VISTA BRITE TIP CATHETERS K965211 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Mar 1997. https://www.510kdatabase.net/k962323/ 1997-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k962323-immulite-opiates-screencontrol-module-fda-510k.jpg K962323 - IMMULITE OPIATES SCREEN/CONTROL MODULE K962323 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Mar 1997. https://www.510kdatabase.net/k964538/ 1997-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k964538-r-port-standard-implantable-vascular-fda-510k.jpg K964538 - R-PORT STANDARD IMPLANTABLE VASCULAR ACCESS SYSTEM K964538 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Boston Scientific Corp. Cleared Mar 1997. https://www.510kdatabase.net/k964865/ 1997-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k964865-pvk-720st-endocavitary-transducer-fda-510k.jpg K964865 - PVK-720ST ENDOCAVITARY TRANSDUCER K964865 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Mar 1997. https://www.510kdatabase.net/k965240/ 1997-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k965240-synchron-lx-20-clinical-chemistry-fda-510k.jpg K965240 - SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON L K965240 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Mar 1997. https://www.510kdatabase.net/k970286/ 1997-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k970286-presbyterian-linen-services-surgical-fda-510k.jpg K970286 - PRESBYTERIAN LINEN SERVICES SURGICAL PACKS K970286 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medline Industries, Inc.. Cleared Mar 1997. https://www.510kdatabase.net/k970666/ 1997-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k970666-liquicheck-urine-toxicology-negative-fda-510k.jpg K970666 - LIQUICHECK URINE TOXICOLOGY NEGATIVE CONTROL K970666 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Mar 1997. https://www.510kdatabase.net/k954488/ 1997-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k954488-roller-electrode-fda-510k.jpg K954488 - ROLLER ELECTRODE K954488 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Olympus America, Inc.. Cleared Mar 1997. https://www.510kdatabase.net/k962781/ 1997-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k962781-corometrics-model-510-and-511-monitor-fda-510k.jpg K962781 - COROMETRICS MODEL 510 AND 511 MONITOR K962781 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Mar 1997. https://www.510kdatabase.net/k963974/ 1997-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k963974-image-immunochemistry-system-urine-fda-510k.jpg K963974 - IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN K963974 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Mar 1997. https://www.510kdatabase.net/k964066/ 1997-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k964066-dual-slim-port-implanted-port-fda-510k.jpg K964066 - DUAL SLIM PORT IMPLANTED PORT (0654970/0654940) K964066 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 1997. https://www.510kdatabase.net/k964843/ 1997-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k964843-immage-immunochemistry-system-fda-510k.jpg K964843 - IMMAGE IMMUNOCHEMISTRY SYSTEM PROPERDIN FACTOR B (PFB) REAGENT K964843 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Mar 1997. https://www.510kdatabase.net/k965108/ 1997-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k965108-synchron-lx-systems-immunoglobulin-gam-fda-510k.jpg K965108 - SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT K965108 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Mar 1997. https://www.510kdatabase.net/k970452/ 1997-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k970452-elecsys-calcheck-cea-fda-510k.jpg K970452 - ELECSYS CALCHECK CEA K970452 is a FDA 510(k) cleared immunology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Mar 1997. https://www.510kdatabase.net/k970458/ 1997-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k970458-elecsys-calcheck-psa-fda-510k.jpg K970458 - ELECSYS CALCHECK PSA K970458 is a FDA 510(k) cleared immunology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Mar 1997. https://www.510kdatabase.net/k970459/ 1997-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k970459-elecsys-calcheck-cea-fda-510k.jpg K970459 - ELECSYS CALCHECK CEA K970459 is a FDA 510(k) cleared immunology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Mar 1997. https://www.510kdatabase.net/k970055/ 1997-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k970055-karl-storz-multidrive-ii-mini-shaver-fda-510k.jpg K970055 - KARL STORZ MULTIDRIVE II MINI SHAVER FOR ARTHROSCOPY K970055 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Mar 1997. https://www.510kdatabase.net/k961661/ 1997-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k961661-oximetrix-4-computer-system-fda-510k.jpg K961661 - OXIMETRIX 4 COMPUTER SYSTEM K961661 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1997. https://www.510kdatabase.net/k964046/ 1997-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k964046-dentsply-precision-torque-system-fda-510k.jpg K964046 - DENTSPLY PRECISION TORQUE SYSTEM K964046 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Mar 1997. https://www.510kdatabase.net/k965229/ 1997-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k965229-imager-torque-catheter-fda-510k.jpg K965229 - IMAGER TORQUE CATHETER K965229 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Mar 1997. https://www.510kdatabase.net/k970047/ 1997-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k970047-phased-array-transducer-psk-20ct-fda-510k.jpg K970047 - PHASED ARRAY TRANSDUCER - - PSK-20CT K970047 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Mar 1997. https://www.510kdatabase.net/k970105/ 1997-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k970105-riwo-cut-morcellator-existing-of-fda-510k.jpg K970105 - RIWO CUT-MORCELLATOR EXISTING OF KNIFE/CUTTING SLEEVE/PROTECTION SLEEVE/CLAW GRASPING FORCEPS K970105 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Mar 1997. https://www.510kdatabase.net/k970527/ 1997-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k970527-abbott-hcg-serum-controls-fda-510k.jpg K970527 - ABBOTT HCG SERUM CONTROLS K970527 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1997. https://www.510kdatabase.net/k964893/ 1997-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k964893-hansson-pin-system-fda-510k.jpg K964893 - HANSSON PIN SYSTEM K964893 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Feb 1997. https://www.510kdatabase.net/k965056/ 1997-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k965056-osteonics-screw-hole-plugs-fda-510k.jpg K965056 - OSTEONICS SCREW HOLE PLUGS K965056 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Feb 1997. https://www.510kdatabase.net/k965098/ 1997-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k965098-intramedullary-nail-system-fda-510k.jpg K965098 - INTRAMEDULLARY NAIL SYSTEM K965098 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Feb 1997. https://www.510kdatabase.net/k965073/ 1997-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k965073-9-x-25mm-standard-interfernece-scre-fda-510k.jpg K965073 - 9 X 25MM STANDARD INTERFERNECE SCRE (S.I.S.) ACL SCREW K965073 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Feb 1997. https://www.510kdatabase.net/k965216/ 1997-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k965216-argi-satin-or-opti0-star-fda-510k.jpg K965216 - ARGI-SATIN OR OPTI0-STAR K965216 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Feb 1997. https://www.510kdatabase.net/k970168/ 1997-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k970168-3m-quikplus-system-fda-510k.jpg K970168 - 3M QUIKPLUS SYSTEM K970168 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Feb 1997. https://www.510kdatabase.net/k963351/ 1997-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k963351-lifeshield-blunt-cannula-fda-510k.jpg K963351 - LIFESHIELD BLUNT CANNULA K963351 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Feb 1997. https://www.510kdatabase.net/k963406/ 1997-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k963406-uhe-collimator-210591-fda-510k.jpg K963406 - UHE COLLIMATOR (210591) K963406 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Feb 1997. https://www.510kdatabase.net/k964780/ 1997-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k964780-bard-director-guidewire-000560-fda-510k.jpg K964780 - BARD DIRECTOR GUIDEWIRE (000560) K964780 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Feb 1997. https://www.510kdatabase.net/k962981/ 1997-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k962981-capiox-sp-pump-head-fda-510k.jpg K962981 - CAPIOX SP PUMP HEAD K962981 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Feb 1997. https://www.510kdatabase.net/k964142/ 1997-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k964142-medline-disposable-surgical-drapes-and-fda-510k.jpg K964142 - MEDLINE DISPOSABLE SURGICAL DRAPES AND GOWNS K964142 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Feb 1997. https://www.510kdatabase.net/k964850/ 1997-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k964850-solution-administration-set-with-022-fda-510k.jpg K964850 - SOLUTION ADMINISTRATION SET WITH 0.22 MICRON HIGH PRESSURE EXTENDED LIFE FILTER K964850 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Feb 1997. https://www.510kdatabase.net/k964752/ 1997-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k964752-kinematic-positioning-devices-fda-510k.jpg K964752 - KINEMATIC POSITIONING DEVICES K964752 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Feb 1997. https://www.510kdatabase.net/k964951/ 1997-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k964951-kinemax-plus-tibial-spacers-fda-510k.jpg K964951 - KINEMAX PLUS TIBIAL SPACERS K964951 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Feb 1997. https://www.510kdatabase.net/k962765/ 1997-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k962765-cordis-marker-wire-steerable-guidewire-fda-510k.jpg K962765 - CORDIS MARKER WIRE STEERABLE GUIDEWIRE (STABILIZER WITH RADIOPAQUE MARKERS) AND (WIZDOM WITH RADIOPAQUE MARKERS) K962765 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Feb 1997. https://www.510kdatabase.net/k964712/ 1997-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k964712-prism-xpvt-system-210823-fda-510k.jpg K964712 - PRISM XPVT SYSTEM (210823) K964712 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Feb 1997. https://www.510kdatabase.net/k964770/ 1997-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k964770-corometrics-120-series-maternalfetal-fda-510k.jpg K964770 - COROMETRICS 120 SERIES MATERNAL/FETAL MONITOR K964770 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Feb 1997. https://www.510kdatabase.net/k963000/ 1997-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k963000-maxi-ld-pta-balloon-catheter-fda-510k.jpg K963000 - MAXI LD PTA BALLOON CATHETER K963000 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Feb 1997. https://www.510kdatabase.net/k964061/ 1997-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k964061-gore-angioscopic-valvvlotome-kit-tbd-fda-510k.jpg K964061 - GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD) K964061 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Feb 1997. https://www.510kdatabase.net/k964963/ 1997-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k964963-lyphochek-coagulation-control-fda-510k.jpg K964963 - LYPHOCHEK COAGULATION CONTROL K964963 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bio-Rad. Cleared Feb 1997. https://www.510kdatabase.net/k965114/ 1997-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k965114-tumor-marker-control-fda-510k.jpg K965114 - TUMOR MARKER CONTROL K965114 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Feb 1997. https://www.510kdatabase.net/k965116/ 1997-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k965116-abbott-testpack-plus-hcg-combo-with-obc-fda-510k.jpg K965116 - ABBOTT TESTPACK PLUS HCG COMBO WITH OBC K965116 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Feb 1997. https://www.510kdatabase.net/k964305/ 1997-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k964305-nihon-kohden-olg-100a-pocketcap-pocket-fda-510k.jpg K964305 - NIHON KOHDEN OLG-100A POCKETCAP POCKET CO2 MONITOR WITH ACCESSORIES K964305 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Feb 1997. https://www.510kdatabase.net/k964795/ 1997-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k964795-cemented-calcar-replacement-femoral-stem-fda-510k.jpg K964795 - CEMENTED CALCAR REPLACEMENT FEMORAL STEM K964795 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Feb 1997. https://www.510kdatabase.net/k960363/ 1997-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k960363-bipolar-shoulder-prosthesis-shellrd-fda-510k.jpg K960363 - BIPOLAR SHOULDER PROSTHESIS-SHELL(RD-113130/33, BIANGULAR MODULAR HEAD(RD-113101/41/42,BIOMODULAR MODULAR HEAD(RD-113143 K960363 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Feb 1997. https://www.510kdatabase.net/k963640/ 1997-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k963640-olympus-acid-phosphatase-reagent-fda-510k.jpg K963640 - OLYMPUS ACID PHOSPHATASE REAGENT K963640 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus America, Inc.. Cleared Feb 1997. https://www.510kdatabase.net/k965109/ 1997-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k965109-elecsys-estradiol-assay-fda-510k.jpg K965109 - ELECSYS ESTRADIOL ASSAY K965109 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Feb 1997. https://www.510kdatabase.net/k964653/ 1997-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k964653-oasis-humidifier-fda-510k.jpg K964653 - OASIS HUMIDIFIER K964653 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Feb 1997. https://www.510kdatabase.net/k963045/ 1997-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k963045-synthes-usa-universal-sacral-system-fda-510k.jpg K963045 - SYNTHES (U.S.A.) UNIVERSAL SACRAL SYSTEM K963045 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Feb 1997. https://www.510kdatabase.net/k963148/ 1997-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k963148-nexgen-complete-knee-solution-fda-510k.jpg K963148 - NEXGEN COMPLETE KNEE SOLUTION K963148 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Feb 1997. https://www.510kdatabase.net/k964079/ 1997-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k964079-speedband-multiple-band-ligator-fda-510k.jpg K964079 - SPEEDBAND MULTIPLE BAND LIGATOR K964079 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Feb 1997. https://www.510kdatabase.net/k964769/ 1997-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k964769-versys-hip-system-fiber-metal-taper-fda-510k.jpg K964769 - VERSYS HIP SYSTEM--FIBER METAL TAPER HIP PROSTHESIS K964769 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Feb 1997. https://www.510kdatabase.net/k963115/ 1997-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k963115-trocar-cannula-fda-510k.jpg K963115 - TROCAR CANNULA K963115 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Feb 1997. https://www.510kdatabase.net/k964009/ 1997-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k964009-immage-immunochemistry-system-fda-510k.jpg K964009 - IMMAGE IMMUNOCHEMISTRY SYSTEM GENTAMICIN(GEN)/TOBRAMYCIN(TOB) REAGENT / BECKMAN DRUG CLAIBRATOR 3 PLUS K964009 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Feb 1997. https://www.510kdatabase.net/k964544/ 1997-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k964544-osteonics-spinal-system-variable-fda-510k.jpg K964544 - OSTEONICS SPINAL SYSTEM - VARIABLE OFFSET CONNECTOR ASSEMBLY K964544 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Feb 1997. https://www.510kdatabase.net/k964678/ 1997-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k964678-phased-array-neck-coil-fda-510k.jpg K964678 - PHASED ARRAY NECK COIL K964678 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Feb 1997. https://www.510kdatabase.net/k961552/ 1997-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k961552-cvp-polyurethane-catheter-fda-510k.jpg K961552 - CVP POLYURETHANE CATHETER K961552 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Feb 1997. https://www.510kdatabase.net/k963868/ 1997-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k963868-immage-immunochemistry-system-fda-510k.jpg K963868 - IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM) K963868 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Feb 1997. https://www.510kdatabase.net/k964010/ 1997-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k964010-immage-immunochemistry-system-fda-510k.jpg K964010 - IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN B REAGENT K964010 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Feb 1997. https://www.510kdatabase.net/k964260/ 1997-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k964260-immage-immunochemistry-system-kappa-fda-510k.jpg K964260 - IMMAGE IMMUNOCHEMISTRY SYSTEM KAPPA LIGHT CHAIN (KAP) REAGENT IMMAGE IMMUNOCHEMISTRY SYSTEM LAMDA LIGHT CHAIN (LAM) REAG K964260 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Feb 1997. https://www.510kdatabase.net/k964372/ 1997-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k964372-cardiac-t-troponin-t-rapid-assay-fda-510k.jpg K964372 - CARDIAC T TROPONIN T RAPID ASSAY K964372 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Feb 1997. https://www.510kdatabase.net/k964626/ 1997-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k964626-edgevista-system-enhancement-package-fda-510k.jpg K964626 - EDGE/VISTA SYSTEM ENHANCEMENT PACKAGE K964626 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Feb 1997. https://www.510kdatabase.net/k964747/ 1997-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k964747-somatom-plus-4-ct-scanner-fda-510k.jpg K964747 - SOMATOM PLUS 4 CT SCANNER K964747 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 1997. https://www.510kdatabase.net/k965202/ 1997-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k965202-vacutainer-brand-safety-lok-blood-fda-510k.jpg K965202 - VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET K965202 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Feb 1997. https://www.510kdatabase.net/k970054/ 1997-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k970054-tandemrx-fda-510k.jpg K970054 - TANDEMRX K970054 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Boston Scientific Corp. Cleared Feb 1997. https://www.510kdatabase.net/k970147/ 1997-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k970147-elecsys-calcheck-prolactin-fda-510k.jpg K970147 - ELECSYS CALCHECK PROLACTIN K970147 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Feb 1997. https://www.510kdatabase.net/k970148/ 1997-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k970148-elecsys-calcheck-estradiol-fda-510k.jpg K970148 - ELECSYS CALCHECK ESTRADIOL K970148 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Feb 1997. https://www.510kdatabase.net/k963023/ 1997-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k963023-ultrasound-gastroscope-gf-type-um30p-fda-510k.jpg K963023 - ULTRASOUND GASTROSCOPE GF TYPE UM30P K963023 is a FDA 510(k) cleared radiology medical device. Manufacturer: Olympus America, Inc.. Cleared Feb 1997. https://www.510kdatabase.net/k960534/ 1997-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k960534-metallic-spherical-cmc-implant-fda-510k.jpg K960534 - METALLIC SPHERICAL CMC IMPLANT K960534 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Feb 1997. https://www.510kdatabase.net/k960659/ 1997-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k960659-ceramic-spherical-cmc-implant-subject-fda-510k.jpg K960659 - CERAMIC SPHERICAL CMC IMPLANT (SUBJECT TO MARKETING APPROVAL) K960659 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Feb 1997. https://www.510kdatabase.net/k963139/ 1997-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k963139-olympus-transferrin-immunoturbidimetric-fda-510k.jpg K963139 - OLYMPUS TRANSFERRIN IMMUNOTURBIDIMETRIC REAGENT K963139 is a FDA 510(k) cleared immunology medical device. Manufacturer: Olympus America, Inc.. Cleared Feb 1997. https://www.510kdatabase.net/k964521/ 1997-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k964521-depuy-dupont-phantom-suture-anchor-fda-510k.jpg K964521 - DEPUY DUPONT PHANTOM SUTURE ANCHOR K964521 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Feb 1997. https://www.510kdatabase.net/k964655/ 1997-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k964655-uhmwpe-hip-and-knee-components-fda-510k.jpg K964655 - UHMWPE HIP AND KNEE COMPONENTS - PACKAGING CHANGE K964655 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Feb 1997. https://www.510kdatabase.net/k964786/ 1997-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k964786-anchorlok-rl-soft-tissue-anchor-system-fda-510k.jpg K964786 - ANCHORLOK RL SOFT TISSUE ANCHOR SYSTEM K964786 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Feb 1997. https://www.510kdatabase.net/k965038/ 1997-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k965038-gore-tex-soft-tissue-patch-fda-510k.jpg K965038 - GORE-TEX SOFT TISSUE PATCH PLUS/DUALMESH PLUS BIOMATERIAL/MYCROMESH PLUS BIOMATERIAL/DUALMESH PLUS BIOMATERIAL WITH HOLE K965038 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Feb 1997. https://www.510kdatabase.net/k961968/ 1997-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k961968-bblcrystal-gram-positive-id-system-fda-510k.jpg K961968 - BBLCRYSTAL GRAM-POSITIVE ID SYSTEM K961968 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Feb 1997. https://www.510kdatabase.net/k963673/ 1997-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k963673-immage-immunochemistry-system-tdm-fda-510k.jpg K963673 - IMMAGE IMMUNOCHEMISTRY SYSTEM TDM (CAR,PHE,PHY, & THE) REAGENTS K963673 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Feb 1997. https://www.510kdatabase.net/k964670/ 1997-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k964670-roche-cobas-fp-reagents-for-tobramycin-fda-510k.jpg K964670 - ROCHE COBAS-FP REAGENTS FOR TOBRAMYCIN K964670 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Feb 1997. https://www.510kdatabase.net/k963671/ 1997-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k963671-osteonics-flanged-polyethylene-fda-510k.jpg K963671 - OSTEONICS FLANGED POLYETHYLENE ACETABULAR CUP K963671 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Feb 1997. https://www.510kdatabase.net/k964363/ 1997-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k964363-bipap-duet-system-fda-510k.jpg K964363 - BIPAP DUET SYSTEM K964363 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Jan 1997. https://www.510kdatabase.net/k970146/ 1997-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k970146-elecsys-calcheck-testosterone-fda-510k.jpg K970146 - ELECSYS CALCHECK TESTOSTERONE K970146 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jan 1997. https://www.510kdatabase.net/k962291/ 1997-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k962291-siemens-sc9000sc9015-bedside-fda-510k.jpg K962291 - SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM K962291 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 1997. https://www.510kdatabase.net/k964379/ 1997-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k964379-ksea-puncture-cannula-fda-510k.jpg K964379 - KSEA PUNCTURE CANNULA K964379 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jan 1997. https://www.510kdatabase.net/k964352/ 1997-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k964352-torque-device-fda-510k.jpg K964352 - TORQUE DEVICE K964352 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Jan 1997. https://www.510kdatabase.net/k964611/ 1997-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k964611-transend-guidewire-fda-510k.jpg K964611 - TRANSEND GUIDEWIRE K964611 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Jan 1997. https://www.510kdatabase.net/k965067/ 1997-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k965067-dilation-catheter-balloon-fda-510k.jpg K965067 - DILATION CATHETER, BALLOON K965067 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Jan 1997. https://www.510kdatabase.net/k963946/ 1997-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k963946-osteonics-modular-acetabular-cup-fda-510k.jpg K963946 - OSTEONICS MODULAR ACETABULAR CUP (MICROSTRUCTURED VERSION) K963946 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Jan 1997. https://www.510kdatabase.net/k964761/ 1997-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k964761-sam-facial-implant-wintroducer-fda-510k.jpg K964761 - S.A.M. FACIAL IMPLANT W/INTRODUCER K964761 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Jan 1997. https://www.510kdatabase.net/k970059/ 1997-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k970059-kodak-miniloader2000-fda-510k.jpg K970059 - KODAK MINILOADER(2000) K970059 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Jan 1997. https://www.510kdatabase.net/k964694/ 1997-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k964694-elecsys-lh-assay-fda-510k.jpg K964694 - ELECSYS LH ASSAY K964694 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jan 1997. https://www.510kdatabase.net/k964704/ 1997-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k964704-depuyace-modified-medical-aspect-mma-fda-510k.jpg K964704 - DEPUY/ACE MODIFIED MEDICAL ASPECT (MMA) FRACTURE STEM K964704 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jan 1997. https://www.510kdatabase.net/k964746/ 1997-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k964746-hispeed-cti-with-performix-tube-and-fda-510k.jpg K964746 - HISPEED CT/I WITH PERFORMIX TUBE AND WARP SCAN OPTION K964746 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Jan 1997. https://www.510kdatabase.net/k964764/ 1997-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k964764-opus-bone-alp-fda-510k.jpg K964764 - OPUS BONE ALP K964764 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Jan 1997. https://www.510kdatabase.net/k964937/ 1997-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k964937-a-lithotripter-compatible-basket-fda-510k.jpg K964937 - A LITHOTRIPTER-COMPATIBLE BASKET K964937 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Jan 1997. https://www.510kdatabase.net/k965156/ 1997-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k965156-ultimaunipolar-head-and-adapter-sleeves-fda-510k.jpg K965156 - ULTIMA*UNIPOLAR HEAD AND ADAPTER SLEEVES K965156 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jan 1997. https://www.510kdatabase.net/k970082/ 1997-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k970082-abbott-advisor-one-step-pregnancy-test-fda-510k.jpg K970082 - ABBOTT ADVISOR ONE-STEP PREGNANCY TEST K970082 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jan 1997. https://www.510kdatabase.net/k962251/ 1997-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k962251-medoff-sliding-plate-proposed-name-fda-510k.jpg K962251 - MEDOFF SLIDING PLATE (PROPOSED NAME) K962251 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jan 1997. https://www.510kdatabase.net/k964525/ 1997-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k964525-prime-bond-21-mp-dentinenamel-bonding-fda-510k.jpg K964525 - PRIME & BOND 2.1 M.P. DENTIN/ENAMEL BONDING AGENT W/ACTIVATOR K964525 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jan 1997. https://www.510kdatabase.net/k965149/ 1997-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k965149-act-i-fda-510k.jpg K965149 - A.C.T. I K965149 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Jan 1997. https://www.510kdatabase.net/k965150/ 1997-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k965150-act-iv-fda-510k.jpg K965150 - A.C.T. IV K965150 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Jan 1997. https://www.510kdatabase.net/k965151/ 1997-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k965151-act-iii-fda-510k.jpg K965151 - A.C.T. III K965151 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Jan 1997. https://www.510kdatabase.net/k965152/ 1997-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k965152-act-ii-fda-510k.jpg K965152 - A.C.T. II K965152 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Jan 1997. https://www.510kdatabase.net/k964748/ 1997-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k964748-elecsys-prolactin-assay-fda-510k.jpg K964748 - ELECSYS PROLACTIN ASSAY K964748 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jan 1997. https://www.510kdatabase.net/k964995/ 1997-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k964995-sas-one-step-pregnancy-fda-510k.jpg K964995 - SAS ONE-STEP PREGNANCY K964995 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sa Scientific, Inc.. Cleared Jan 1997. https://www.510kdatabase.net/k962404/ 1997-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k962404-siemens-sc-6000-sc-6000-p-portable-fda-510k.jpg K962404 - SIEMENS SC 6000 & SC 6000 P PORTABLE BEDSIDE MONITORING SYSTEM K962404 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 1997. https://www.510kdatabase.net/k963535/ 1997-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k963535-sigma-diagnostics-glucose-reagent-fda-510k.jpg K963535 - SIGMA DIAGNOSTICS GLUCOSE REAGENT K963535 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Jan 1997. https://www.510kdatabase.net/k963695/ 1997-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k963695-immulite-anti-tpo-ablktoilkt05lktoz-fda-510k.jpg K963695 - IMMULITE ANTI-TPO-AB(LKTOI,LKT05,LKTOZ K963695 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jan 1997. https://www.510kdatabase.net/k964304/ 1997-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k964304-osteonics-spinal-system-toploading-fda-510k.jpg K964304 - OSTEONICS SPINAL SYSTEM-TOPLOADING TRANSVERSE CONNECTOR ASSEMBLY K964304 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Jan 1997. https://www.510kdatabase.net/k964306/ 1997-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k964306-magnetic-resonance-diagnostic-accessory-fda-510k.jpg K964306 - MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY K964306 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jan 1997. https://www.510kdatabase.net/k965157/ 1997-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k965157-cedia-dau-multi-drug-control-cedia-dau-fda-510k.jpg K965157 - CEDIA DAU MULTI-DRUG CONTROL CEDIA DAU SPECIALTY CONTROL SET 1 K965157 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jan 1997. https://www.510kdatabase.net/k964258/ 1997-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k964258-instruments-for-endoscopic-subfascial-fda-510k.jpg K964258 - INSTRUMENTS FOR ENDOSCOPIC SUBFASCIAL DISCISION OF PERFORATING VINS ESDP, MODEL 8781 K964258 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Jan 1997. https://www.510kdatabase.net/k964581/ 1997-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k964581-sofsilk-fda-510k.jpg K964581 - SOFSILK K964581 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Jan 1997. https://www.510kdatabase.net/k964527/ 1997-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k964527-n-rheumatology-standard-sl-fda-510k.jpg K964527 - N RHEUMATOLOGY STANDARD SL K964527 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Jan 1997. https://www.510kdatabase.net/k963424/ 1997-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k963424-olympus-lipase-reagent-fda-510k.jpg K963424 - OLYMPUS LIPASE REAGENT K963424 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus America, Inc.. Cleared Jan 1997. https://www.510kdatabase.net/k964249/ 1997-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k964249-bridge-long-stem-femoral-component-fda-510k.jpg K964249 - BRIDGE LONG STEM FEMORAL COMPONENT K964249 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jan 1997. https://www.510kdatabase.net/k962914/ 1997-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k962914-rep-3-quto-flur-cholesterol-30-fda-510k.jpg K962914 - REP 3 QUTO-FLUR CHOLESTEROL-30 K962914 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Jan 1997. https://www.510kdatabase.net/k964457/ 1997-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k964457-roche-cobas-ibtegra-reagent-cassettes-fda-510k.jpg K964457 - ROCHE COBAS IBTEGRA REAGENT CASSETTES K964457 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jan 1997. https://www.510kdatabase.net/k965171/ 1997-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k965171-liquichek-urianlysis-control-cat-no-fda-510k.jpg K965171 - LIQUICHEK URIANLYSIS CONTROL (CAT. NO. 420,421,422,425,426) K965171 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Jan 1997. https://www.510kdatabase.net/k963221/ 1997-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k963221-optical-digitizer-option-for-view-point-fda-510k.jpg K963221 - OPTICAL DIGITIZER OPTION FOR VIEW POINT K963221 is a FDA 510(k) cleared neurology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Jan 1997. https://www.510kdatabase.net/k964136/ 1997-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k964136-hystero-co2-pneu-2221-fda-510k.jpg K964136 - HYSTERO CO2-PNEU 2221 K964136 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Jan 1997. https://www.510kdatabase.net/k964138/ 1997-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k964138-varian-ximatron-c-series-radiation-fda-510k.jpg K964138 - VARIAN XIMATRON C-SERIES RADIATION THERAPY SIMULATOR WITH VERSION 4.2 SOFTWARE K964138 is a FDA 510(k) cleared radiology medical device. Manufacturer: Varian Medical Systems, Inc.. Cleared Jan 1997. https://www.510kdatabase.net/k964370/ 1997-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k964370-magnetic-resonance-diagnostic-system-fda-510k.jpg K964370 - MAGNETIC RESONANCE DIAGNOSTIC SYSTEM K964370 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Jan 1997. https://www.510kdatabase.net/k963109/ 1997-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k963109-heritage-hip-system-fda-510k.jpg K963109 - HERITAGE HIP SYSTEM K963109 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jan 1997. https://www.510kdatabase.net/k963357/ 1997-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k963357-modification-to-the-synthes-usa-fda-510k.jpg K963357 - MODIFICATION TO THE SYNTHES (USA) UNIVERSAL SPINAL HOOK, ROD, AND AND SACRAL SCREW FIXATION SYSTEM IN 316L STAINLESS STE K963357 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jan 1997. https://www.510kdatabase.net/k964259/ 1997-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k964259-synthes-usa-ddhsdcs-system-modification-fda-510k.jpg K964259 - SYNTHES (USA) DDHS/DCS SYSTEM MODIFICATION K964259 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jan 1997. https://www.510kdatabase.net/k965084/ 1997-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k965084-vidas-proesterone-prg-30-409-fda-510k.jpg K965084 - VIDAS PROESTERONE (PRG) (30 409) K965084 is a FDA 510(k) cleared chemistry medical device. Manufacturer: bioMerieux, Inc.. Cleared Jan 1997. https://www.510kdatabase.net/k964122/ 1997-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k964122-hp-star-st-and-arrhhythmia-software-fda-510k.jpg K964122 - HP STAR ST AND ARRHHYTHMIA SOFTWARE K964122 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Jan 1997. https://www.510kdatabase.net/k964218/ 1997-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k964218-perfecta-plasma-spray-hip-stem-fda-510k.jpg K964218 - PERFECTA PLASMA SPRAY HIP STEM K964218 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jan 1997. https://www.510kdatabase.net/k964012/ 1997-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k964012-genie-processing-and-review-workstation-fda-510k.jpg K964012 - GENIE PROCESSING AND REVIEW WORKSTATION K964012 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Jan 1997. https://www.510kdatabase.net/k964284/ 1997-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k964284-stainless-steel-greenfield-vena-cava-fda-510k.jpg K964284 - STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F INTRODUCER SYSTEM K964284 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Jan 1997. https://www.510kdatabase.net/k963184/ 1996-12-31 monthly 0.5 https://www.510kdatabase.net/og-image/k963184-olympus-subcutaneous-endoscopy-system-fda-510k.jpg K963184 - OLYMPUS SUBCUTANEOUS ENDOSCOPY SYSTEM K963184 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Olympus America, Inc.. Cleared Dec 1996. https://www.510kdatabase.net/k962486/ 1996-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k962486-depuy-motech-anterior-compression-fda-510k.jpg K962486 - DEPUY MOTECH ANTERIOR COMPRESSION PLATE SYSTEM K962486 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Dec 1996. https://www.510kdatabase.net/k964262/ 1996-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k964262-exactech-total-hip-systme-22mm-femoral-fda-510k.jpg K964262 - EXACTECH TOTAL HIP SYSTME: 22MM FEMORAL HEAD K964262 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Dec 1996. https://www.510kdatabase.net/k960982/ 1996-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k960982-monoject-blunt-iv-access-fda-510k.jpg K960982 - MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. ACCESS CANNULA K960982 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Dec 1996. https://www.510kdatabase.net/k964453/ 1996-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k964453-rep-3-flur-spe-60-kit-fda-510k.jpg K964453 - REP 3 FLUR SPE-60 KIT K964453 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Dec 1996. https://www.510kdatabase.net/k964471/ 1996-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k964471-rep-flur-cholesterol-60-kit-fda-510k.jpg K964471 - REP FLUR CHOLESTEROL-60 KIT K964471 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Dec 1996. https://www.510kdatabase.net/k964659/ 1996-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k964659-orthoralix-egx-9000-panoramic-x-ray-fda-510k.jpg K964659 - ORTHORALIX E/GX-9000 PANORAMIC X-RAY SYSTEM K964659 is a FDA 510(k) cleared radiology medical device. Manufacturer: Dentsply Intl.. Cleared Dec 1996. https://www.510kdatabase.net/k952721/ 1996-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k952721-rubascan-card-test-fda-510k.jpg K952721 - RUBASCAN CARD TEST K952721 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Dec 1996. https://www.510kdatabase.net/k955265/ 1996-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k955265-cordis-sharp-ended-stylet-fda-510k.jpg K955265 - CORDIS SHARP-ENDED STYLET K955265 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cordis Corp.. Cleared Dec 1996. https://www.510kdatabase.net/k955324/ 1996-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k955324-bipap-st-d-30-system-fda-510k.jpg K955324 - BIPAP S/T-D 30 SYSTEM K955324 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Dec 1996. https://www.510kdatabase.net/k962474/ 1996-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k962474-olympus-fg-series-of-rat-tooth-fda-510k.jpg K962474 - OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (UROLOGY) K962474 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus America, Inc.. Cleared Dec 1996. https://www.510kdatabase.net/k963825/ 1996-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k963825-auto-suture-abbi-system-fda-510k.jpg K963825 - AUTO SUTURE* ABBI* SYSTEM K963825 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Dec 1996. https://www.510kdatabase.net/k963960/ 1996-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k963960-ksea-unimat-plus-fda-510k.jpg K963960 - KSEA UNIMAT PLUS K963960 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Dec 1996. https://www.510kdatabase.net/k963949/ 1996-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k963949-ksea-unimat-plus-fda-510k.jpg K963949 - KSEA UNIMAT PLUS K963949 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Dec 1996. https://www.510kdatabase.net/k963959/ 1996-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k963959-osteonics-modular-acetabular-cup-ha-fda-510k.jpg K963959 - OSTEONICS MODULAR ACETABULAR CUP (HA-COATED VERSION) K963959 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Dec 1996. https://www.510kdatabase.net/k963896/ 1996-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k963896-mobile-ct-prospeed-family-fda-510k.jpg K963896 - MOBILE CT PROSPEED FAMILY K963896 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Dec 1996. https://www.510kdatabase.net/k964072/ 1996-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k964072-monocryl-poliglecaprone-25-suture-undyed-fda-510k.jpg K964072 - MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED K964072 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Dec 1996. https://www.510kdatabase.net/k962538/ 1996-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k962538-bard-coagulating-resector-model-3552xx-fda-510k.jpg K962538 - BARD COAGULATING RESECTOR MODEL (3552XX K962538 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 1996. https://www.510kdatabase.net/k962894/ 1996-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k962894-synthes-high-tibial-osteotomy-hto-system-fda-510k.jpg K962894 - SYNTHES HIGH TIBIAL OSTEOTOMY (HTO) SYSTEM K962894 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Dec 1996. https://www.510kdatabase.net/k954610/ 1996-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k954610-model-430-07-endocardial-pacing-lead-fda-510k.jpg K954610 - MODEL 430-07 ENDOCARDIAL PACING LEAD K954610 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Dec 1996. https://www.510kdatabase.net/k960643/ 1996-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k960643-advantage-mapf-hip-femoral-component-fda-510k.jpg K960643 - ADVANTAGE MAPF HIP FEMORAL COMPONENT K960643 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Dec 1996. https://www.510kdatabase.net/k962230/ 1996-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k962230-celsite-port-with-preconnected-catheter-fda-510k.jpg K962230 - CELSITE PORT WITH PRECONNECTED CATHETER K962230 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Dec 1996. https://www.510kdatabase.net/k962641/ 1996-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k962641-maxima-forte-hollow-fiber-oxygenator-fda-510k.jpg K962641 - MAXIMA FORTE HOLLOW FIBER OXYGENATOR WITH PLASMA RESISTANT FIBER K962641 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Dec 1996. https://www.510kdatabase.net/k963127/ 1996-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k963127-elecsys-ft3-fda-510k.jpg K963127 - ELECSYS FT3 K963127 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Dec 1996. https://www.510kdatabase.net/k963539/ 1996-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k963539-sigma-diagnostics-wash-concentrate-fda-510k.jpg K963539 - SIGMA DIAGNOSTICS WASH CONCENTRATE K963539 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Dec 1996. https://www.510kdatabase.net/k963973/ 1996-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k963973-depuy-cannulated-cross-pin-screw-system-fda-510k.jpg K963973 - DEPUY CANNULATED CROSS PIN SCREW SYSTEM K963973 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Dec 1996. https://www.510kdatabase.net/k964345/ 1996-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k964345-ethicon-absorbable-poly-l-fda-510k.jpg K964345 - ETHICON ABSORBABLE POLY (L-LACTIDE/GLYCOLIDE) SURGICAL SUTURE, UNDYED K964345 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Dec 1996. https://www.510kdatabase.net/k964687/ 1996-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k964687-n-latex-crp-mono-reagent-fda-510k.jpg K964687 - N LATEX CRP MONO REAGENT K964687 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Dec 1996. https://www.510kdatabase.net/k964693/ 1996-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k964693-elecsys-fsh-assay-fda-510k.jpg K964693 - ELECSYS FSH ASSAY K964693 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Dec 1996. https://www.510kdatabase.net/k964829/ 1996-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k964829-elecsys-calcheck-fsh-fda-510k.jpg K964829 - ELECSYS CALCHECK FSH K964829 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Dec 1996. https://www.510kdatabase.net/k964830/ 1996-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k964830-elecsys-calcheck-lh-fda-510k.jpg K964830 - ELECSYS CALCHECK LH K964830 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Dec 1996. https://www.510kdatabase.net/k962212/ 1996-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k962212-karl-storz-frimberger-varioguide-fda-510k.jpg K962212 - KARL STORZ FRIMBERGER VARIOGUIDE K962212 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Dec 1996. https://www.510kdatabase.net/k962968/ 1996-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k962968-proc-apc-assay-proc-control-plasma-fda-510k.jpg K962968 - PROC APC ASSAY, PROC CONTROL PLASMA K962968 is a FDA 510(k) cleared hematology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Dec 1996. https://www.510kdatabase.net/k963062/ 1996-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k963062-immage-system-digoxin-dig-fda-510k.jpg K963062 - IMMAGE SYSTEM DIGOXIN (DIG) REAGENT/BECKMAN DRUG CALIBRATOR 2 K963062 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Dec 1996. https://www.510kdatabase.net/k964173/ 1996-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k964173-c-mount-objective-lens-f-17-mm-steam-fda-510k.jpg K964173 - C-MOUNT OBJECTIVE LENS F = 17 MM, STEAM-STERILIZABLE: MODEL 85 261.172, C-MOUNT OBJECTIVE LENS F = 21 MM, STEAM-STERILIZ K964173 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Dec 1996. https://www.510kdatabase.net/k964328/ 1996-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k964328-synthes-usa-synthes-mmfs-adjustable-fda-510k.jpg K964328 - SYNTHES (USA) SYNTHES MMFS-ADJUSTABLE SAGITTAL SPLIT PLATE K964328 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Dec 1996. https://www.510kdatabase.net/k964355/ 1996-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k964355-ontrak-testcup-5-modification-fda-510k.jpg K964355 - ONTRAK TESTCUP 5 (MODIFICATION) K964355 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Dec 1996. https://www.510kdatabase.net/k963691/ 1996-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k963691-courier-balloon-dilatation-catheter-fda-510k.jpg K963691 - COURIER BALLOON DILATATION CATHETER K963691 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Dec 1996. https://www.510kdatabase.net/k963839/ 1996-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k963839-cordis-suction-reservoir-model-number-fda-510k.jpg K963839 - CORDIS SUCTION RESERVOIR - MODEL NUMBER: 910-500 K963839 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cordis Corp.. Cleared Dec 1996. https://www.510kdatabase.net/k963988/ 1996-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k963988-intravascular-infusion-device-fda-510k.jpg K963988 - INTRAVASCULAR INFUSION DEVICE K963988 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Dec 1996. https://www.510kdatabase.net/k950719/ 1996-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k950719-oes-urology-fda-510k.jpg K950719 - OES UROLOGY K950719 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus America, Inc.. Cleared Dec 1996. https://www.510kdatabase.net/k961908/ 1996-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k961908-thor-henostatsis-analyzer-cat-no-1450-fda-510k.jpg K961908 - THOR HENOSTATSIS ANALYZER CAT. NO. 1450, 1451 K961908 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Dec 1996. https://www.510kdatabase.net/k962734/ 1996-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k962734-cedia-dau-benzodiazepine-assay-fda-510k.jpg K962734 - CEDIA DAU BENZODIAZEPINE ASSAY K962734 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Dec 1996. https://www.510kdatabase.net/k963852/ 1996-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k963852-ksea-thermocoagulator-model-265100-20-fda-510k.jpg K963852 - KSEA THERMOCOAGULATOR (MODEL 265100 20) K963852 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Dec 1996. https://www.510kdatabase.net/k962314/ 1996-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k962314-halifax-plus-interlaminar-clamp-system-fda-510k.jpg K962314 - HALIFAX PLUS INTERLAMINAR CLAMP SYSTEM K962314 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Dec 1996. https://www.510kdatabase.net/k962608/ 1996-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k962608-synthes-usa-universal-spinal-parallel-fda-510k.jpg K962608 - SYNTHES (U.S.A.) UNIVERSAL SPINAL PARALLEL CONNECTOR K962608 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Dec 1996. https://www.510kdatabase.net/k962880/ 1996-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k962880-sensi-touch-combo-spinalepidural-fda-510k.jpg K962880 - SENSI-TOUCH COMBO SPINAL/EPIDURAL REGIONAL ANESTHESIA DELIVERY SYSTEM K962880 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sherwood Medical Co.. Cleared Dec 1996. https://www.510kdatabase.net/k963796/ 1996-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k963796-kinemax-plus-modular-stabilizer-fda-510k.jpg K963796 - KINEMAX PLUS MODULAR STABILIZER FEMORAL COMPONENT AND FEMORAL SPACERS K963796 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Dec 1996. https://www.510kdatabase.net/k963885/ 1996-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k963885-ultima-fx-femoral-hip-stems-fda-510k.jpg K963885 - ULTIMA FX FEMORAL HIP STEMS K963885 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Dec 1996. https://www.510kdatabase.net/k955073/ 1996-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k955073-ksea-thermoflator-model-26-4320-20-fda-510k.jpg K955073 - KSEA THERMOFLATOR (MODEL 26 4320 20) K955073 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Dec 1996. https://www.510kdatabase.net/k964040/ 1996-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k964040-trubyte-soft-reline-system-fda-510k.jpg K964040 - TRUBYTE SOFT RELINE SYSTEM K964040 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Dec 1996. https://www.510kdatabase.net/k962203/ 1996-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k962203-whisper-swivel-ii-exhalation-port-fda-510k.jpg K962203 - WHISPER SWIVEL II EXHALATION PORT K962203 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Dec 1996. https://www.510kdatabase.net/k963709/ 1996-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k963709-cement-on-femoral-stem-fda-510k.jpg K963709 - CEMENT-ON FEMORAL STEM K963709 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Dec 1996. https://www.510kdatabase.net/k962172/ 1996-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k962172-flexible-mini-fiberscopes-fda-510k.jpg K962172 - FLEXIBLE MINI-FIBERSCOPES K962172 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Dec 1996. https://www.510kdatabase.net/k963170/ 1996-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k963170-olympus-ferritin-immunoturbidimetric-fda-510k.jpg K963170 - OLYMPUS FERRITIN IMMUNOTURBIDIMETRIC REAGENT K963170 is a FDA 510(k) cleared immunology medical device. Manufacturer: Olympus America, Inc.. Cleared Dec 1996. https://www.510kdatabase.net/k963705/ 1996-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k963705-color-enhancement-function-for-the-ssa-fda-510k.jpg K963705 - COLOR ENHANCEMENT FUNCTION FOR THE SSA-380A K963705 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Dec 1996. https://www.510kdatabase.net/k953233/ 1996-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k953233-simview-3000-ct-option-fda-510k.jpg K953233 - SIMVIEW 3000 CT OPTION K953233 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 1996. https://www.510kdatabase.net/k962760/ 1996-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k962760-enzymun-test-ft3-fda-510k.jpg K962760 - ENZYMUN-TEST FT3 K962760 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Nov 1996. https://www.510kdatabase.net/k960856/ 1996-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k960856-konstruct-patellar-component-fda-510k.jpg K960856 - KONSTRUCT PATELLAR COMPONENT K960856 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Nov 1996. https://www.510kdatabase.net/k962061/ 1996-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k962061-magnetic-resonance-diagnostic-system-fda-510k.jpg K962061 - MAGNETIC RESONANCE DIAGNOSTIC SYSTEM K962061 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Nov 1996. https://www.510kdatabase.net/k963029/ 1996-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k963029-karl-storz-slotted-whisker-fda-510k.jpg K963029 - KARL STORZ SLOTTED WHISKER ARTHROSCOPIC BLADE K963029 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Nov 1996. https://www.510kdatabase.net/k963429/ 1996-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k963429-magnetic-resonance-diagnostic-system-fda-510k.jpg K963429 - MAGNETIC RESONANCE DIAGNOSTIC SYSTEM K963429 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Nov 1996. https://www.510kdatabase.net/k963798/ 1996-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k963798-synthes-titanium-alloy-volar-distal-fda-510k.jpg K963798 - SYNTHES TITANIUM ALLOY VOLAR DISTAL RADIUS PLATE (TI ALLOY VDRP) SYSTEM K963798 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Nov 1996. https://www.510kdatabase.net/k963999/ 1996-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k963999-auto-suture-modified-endoscopic-fascia-fda-510k.jpg K963999 - AUTO SUTURE* MODIFIED ENDOSCOPIC FASCIA STAPLER** DEVICE K963999 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Nov 1996. https://www.510kdatabase.net/k955756/ 1996-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k955756-karl-storz-point-coagulator-semm-fda-510k.jpg K955756 - KARL STORZ POINT COAGULATOR, SEMM CROCODILE FORCEPS, MYOMA ENUCLEATOR K955756 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Nov 1996. https://www.510kdatabase.net/k962205/ 1996-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k962205-sterile-and-non-sterile-or-towels-fda-510k.jpg K962205 - STERILE AND NON-STERILE O.R. TOWELS, STERILE AND NON-STERILE X-RAY DETECTABLE O.R. TOWELS, SINGLE USE K962205 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Nov 1996. https://www.510kdatabase.net/k963757/ 1996-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k963757-irrigationsuction-handle-and-sheath-fda-510k.jpg K963757 - IRRIGATION/SUCTION HANDLE AND SHEATH K963757 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Nov 1996. https://www.510kdatabase.net/k963397/ 1996-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k963397-ultra-thin-diamond-balloon-dilatation-fda-510k.jpg K963397 - ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER K963397 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Nov 1996. https://www.510kdatabase.net/k963783/ 1996-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k963783-mitek-electrosurgical-system-for-fda-510k.jpg K963783 - MITEK ELECTROSURGICAL SYSTEM FOR ARTHROSCOPIC USE K963783 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Nov 1996. https://www.510kdatabase.net/k964422/ 1996-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k964422-ontrak-testtcup-collectionurinalysis-fda-510k.jpg K964422 - ONTRAK TESTTCUP COLLECTION/URINALYSIS PANEL K964422 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Nov 1996. https://www.510kdatabase.net/k963356/ 1996-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k963356-phased-array-shoulder-coil-fda-510k.jpg K963356 - PHASED ARRAY SHOULDER COIL K963356 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Nov 1996. https://www.510kdatabase.net/k963750/ 1996-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k963750-retrieval-snare-fda-510k.jpg K963750 - RETRIEVAL SNARE K963750 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Nov 1996. https://www.510kdatabase.net/k963323/ 1996-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k963323-endo-vip-fda-510k.jpg K963323 - ENDO VIP K963323 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Nov 1996. https://www.510kdatabase.net/k964062/ 1996-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k964062-n-protein-strandard-sl-fda-510k.jpg K964062 - N PROTEIN STRANDARD SL K964062 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Nov 1996. https://www.510kdatabase.net/k963840/ 1996-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k963840-cedia-phenytoin-ii-assay-fda-510k.jpg K963840 - CEDIA PHENYTOIN II ASSAY K963840 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Nov 1996. https://www.510kdatabase.net/k953742/ 1996-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k953742-bifurcated-y-extension-fda-510k.jpg K953742 - BIFURCATED Y-EXTENSION K953742 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Nov 1996. https://www.510kdatabase.net/k962096/ 1996-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k962096-medline-hypoallergenic-pre-powdered-fda-510k.jpg K962096 - MEDLINE, HYPOALLERGENIC, PRE-POWDERED NON-STERILE AND STERILE LATEX EXAMINATION GLOVES K962096 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Nov 1996. https://www.510kdatabase.net/k962863/ 1996-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k962863-karl-storz-model-264305-20-electronic-fda-510k.jpg K962863 - KARL STORZ MODEL 264305-20 ELECTRONIC ENDOFLATOR K962863 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Nov 1996. https://www.510kdatabase.net/k955733/ 1996-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k955733-hyloc-interference-screw-cannulatednon-fda-510k.jpg K955733 - HYLOC INTERFERENCE SCREW (CANNULATED)/(NON-CANNULATED) K955733 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Nov 1996. https://www.510kdatabase.net/k963245/ 1996-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k963245-immulite-latex-specific-ige-fda-510k.jpg K963245 - IMMULITE LATEX-SPECIFIC IGE K963245 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Nov 1996. https://www.510kdatabase.net/k961509/ 1996-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k961509-intra-aortic-balloon-pump-system-97-fda-510k.jpg K961509 - INTRA-AORTIC BALLOON PUMP SYSTEM 97 MODIFIED K961509 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Nov 1996. https://www.510kdatabase.net/k963226/ 1996-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k963226-surgical-fabrics-fda-510k.jpg K963226 - SURGICAL FABRICS K963226 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Boston Scientific Corp. Cleared Nov 1996. https://www.510kdatabase.net/k962913/ 1996-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k962913-synthes-sterile-drill-bits-fda-510k.jpg K962913 - SYNTHES STERILE DRILL BITS K962913 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Nov 1996. https://www.510kdatabase.net/k963241/ 1996-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k963241-ultraflex-fda-510k.jpg K963241 - ULTRAFLEX K963241 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Boston Scientific Corp. Cleared Nov 1996. https://www.510kdatabase.net/k963242/ 1996-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k963242-duracon-posterior-femoral-spacer-fda-510k.jpg K963242 - DURACON POSTERIOR FEMORAL SPACER K963242 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Nov 1996. https://www.510kdatabase.net/k963250/ 1996-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k963250-pressure-valve-fda-510k.jpg K963250 - PRESSURE VALVE K963250 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Nov 1996. https://www.510kdatabase.net/k963313/ 1996-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k963313-exactech-all-poly-acetabular-cup-fda-510k.jpg K963313 - EXACTECH ALL POLY ACETABULAR CUP K963313 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Nov 1996. https://www.510kdatabase.net/k963350/ 1996-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k963350-depuy-motech-peak-fixation-system-fda-510k.jpg K963350 - DEPUY MOTECH PEAK FIXATION SYSTEM K963350 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Nov 1996. https://www.510kdatabase.net/k961520/ 1996-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k961520-unipolar-ipg-ground-cable-model-5473-fda-510k.jpg K961520 - UNIPOLAR IPG GROUND CABLE, MODEL 5473 K961520 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Nov 1996. https://www.510kdatabase.net/k961605/ 1996-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k961605-karl-storz-105-fr-flexible-hysteroscope-fda-510k.jpg K961605 - KARL STORZ 10.5 FR. FLEXIBLE HYSTEROSCOPE K961605 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Nov 1996. https://www.510kdatabase.net/k963214/ 1996-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k963214-cordis-st-steerable-guidewire-fda-510k.jpg K963214 - CORDIS ST STEERABLE GUIDEWIRE K963214 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Nov 1996. https://www.510kdatabase.net/k963800/ 1996-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k963800-il-synthesis-fda-510k.jpg K963800 - IL SYNTHESIS K963800 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Nov 1996. https://www.510kdatabase.net/k963309/ 1996-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k963309-apex-hole-eliminator-ps-fda-510k.jpg K963309 - APEX HOLE ELIMINATOR PS K963309 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Nov 1996. https://www.510kdatabase.net/k963618/ 1996-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k963618-synthes-simple-small-external-fixator-fda-510k.jpg K963618 - SYNTHES SIMPLE SMALL EXTERNAL FIXATOR (SSEF) K963618 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Nov 1996. https://www.510kdatabase.net/k963172/ 1996-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k963172-synthes-sterile-45-mm-cannulated-screws-fda-510k.jpg K963172 - SYNTHES STERILE 4.5 MM CANNULATED SCREWS K963172 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Nov 1996. https://www.510kdatabase.net/k963192/ 1996-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k963192-synthes-sterile-35-mm-and-40-mm-fda-510k.jpg K963192 - SYNTHES STERILE 3.5 MM AND 4.0 MM CANNULATED SCREWS K963192 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Nov 1996. https://www.510kdatabase.net/k963171/ 1996-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k963171-cinch-qr-sgw-extension-fda-510k.jpg K963171 - CINCH QR SGW EXTENSION K963171 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Nov 1996. https://www.510kdatabase.net/k963179/ 1996-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k963179-magnetic-resonance-diagnostic-system-fda-510k.jpg K963179 - MAGNETIC RESONANCE DIAGNOSTIC SYSTEM K963179 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Nov 1996. https://www.510kdatabase.net/k963426/ 1996-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k963426-karl-storz-contact-micro-laryngoscopes-fda-510k.jpg K963426 - KARL STORZ CONTACT MICRO-LARYNGOSCOPES K963426 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Nov 1996. https://www.510kdatabase.net/k963117/ 1996-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k963117-pfc-cruciate-retaing-knee-system-fda-510k.jpg K963117 - P.F.C. CRUCIATE RETAING KNEE SYSTEM K963117 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Nov 1996. https://www.510kdatabase.net/k963431/ 1996-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k963431-polyester-pil-wristankle-fda-510k.jpg K963431 - POLYESTER PIL WRIST/ANKLE RESTRAINT/WRIST RESTRAINT UNIVERSAL/SOFT FLANNEL WRIST/ANKLE RESTRAINT/FOAM LIMB HOLDER K963431 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Zimmer, Inc.. Cleared Nov 1996. https://www.510kdatabase.net/k963614/ 1996-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k963614-monotube-carbon-tube-fda-510k.jpg K963614 - MONOTUBE CARBON TUBE K963614 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Nov 1996. https://www.510kdatabase.net/k964065/ 1996-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k964065-nt-protein-control-sl-fda-510k.jpg K964065 - N/T PROTEIN CONTROL SL K964065 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Nov 1996. https://www.510kdatabase.net/k964140/ 1996-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k964140-gluma-conditioner-fda-510k.jpg K964140 - GLUMA CONDITIONER K964140 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Nov 1996. https://www.510kdatabase.net/k955122/ 1996-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k955122-intermedics-model-436-07-bipolar-model-fda-510k.jpg K955122 - INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD K955122 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Nov 1996. https://www.510kdatabase.net/k961668/ 1996-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k961668-microferret-catheter-fda-510k.jpg K961668 - MICROFERRET CATHETER K961668 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Nov 1996. https://www.510kdatabase.net/k963048/ 1996-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k963048-immage-system-rheumatoid-factor-rf-fda-510k.jpg K963048 - IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENT K963048 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Nov 1996. https://www.510kdatabase.net/k963061/ 1996-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k963061-immage-immunochemistry-system-c-fda-510k.jpg K963061 - IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT K963061 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Nov 1996. https://www.510kdatabase.net/k963187/ 1996-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k963187-modified-labeling-of-cardiac-assist-fda-510k.jpg K963187 - MODIFIED LABELING OF CARDIAC ASSIST INTRA-AORTIC BALLOON CATHETERS: MODEL 930 - 940, 30 - 40 CC SENSATION AND NICATH 30C K963187 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Nov 1996. https://www.510kdatabase.net/k961272/ 1996-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k961272-nihon-kohden-ecg-9320a-cardiofax-and-fda-510k.jpg K961272 - NIHON KOHDEN ECG-9320A CARDIOFAX AND ACCESSORIES K961272 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Nov 1996. https://www.510kdatabase.net/k961836/ 1996-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k961836-maxima-forte-hardshell-venous-reservoir-fda-510k.jpg K961836 - MAXIMA FORTE HARDSHELL VENOUS RESERVOIR K961836 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Nov 1996. https://www.510kdatabase.net/k962083/ 1996-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k962083-karl-storz-remorgida-forceps-fda-510k.jpg K962083 - KARL STORZ REMORGIDA FORCEPS K962083 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Nov 1996. https://www.510kdatabase.net/k963550/ 1996-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k963550-rinoflow-micronized-ent-wash-sytstem-fda-510k.jpg K963550 - RINOFLOW MICRONIZED E.N..T. WASH SYTSTEM K963550 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Respironics, Inc.. Cleared Nov 1996. https://www.510kdatabase.net/k962764/ 1996-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k962764-neuromag-122-fda-510k.jpg K962764 - NEUROMAG-122 K962764 is a FDA 510(k) cleared neurology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Oct 1996. https://www.510kdatabase.net/k963292/ 1996-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k963292-cobas-integra-reagent-cassettes-fda-510k.jpg K963292 - COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS K963292 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Oct 1996. https://www.510kdatabase.net/k963393/ 1996-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k963393-mesh-vest-restraint-with-sleeves-fda-510k.jpg K963393 - MESH VEST RESTRAINT WITH SLEEVES WRIST/ANKLE RESTRAINT K963393 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Depuy, Inc.. Cleared Oct 1996. https://www.510kdatabase.net/k963766/ 1996-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k963766-3m-proplus-system-fda-510k.jpg K963766 - 3M PROPLUS SYSTEM K963766 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Oct 1996. https://www.510kdatabase.net/k954850/ 1996-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k954850-bard-william-harvey-hf-6000-membrane-fda-510k.jpg K954850 - BARD WILLIAM HARVEY HF-6000 MEMBRANE OXYGENATOR K954850 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 1996. https://www.510kdatabase.net/k962726/ 1996-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k962726-bard-quantum-cvr-fda-510k.jpg K962726 - BARD QUANTUM CVR K962726 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 1996. https://www.510kdatabase.net/k962795/ 1996-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k962795-cedia-dau-opiate-2k-assay-fda-510k.jpg K962795 - CEDIA DAU OPIATE 2K ASSAY K962795 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Oct 1996. https://www.510kdatabase.net/k963543/ 1996-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k963543-sigma-diagnostics-cx-3-calibration-fda-510k.jpg K963543 - SIGMA DIAGNOSTICS CX -3 CALIBRATION STANDARD, LEVEL 2 K963543 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Oct 1996. https://www.510kdatabase.net/k963827/ 1996-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k963827-axsym-free-triiodothyronine-free-t3-fda-510k.jpg K963827 - AXSYM FREE TRIIODOTHYRONINE (FREE T3) K963827 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1996. https://www.510kdatabase.net/k963833/ 1996-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k963833-imx-free-triiodothyronine-free-t3-fda-510k.jpg K963833 - IMX FREE TRIIODOTHYRONINE (FREE T3) K963833 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1996. https://www.510kdatabase.net/k961833/ 1996-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k961833-sonoline-elegra-with-siescape-feature-fda-510k.jpg K961833 - SONOLINE ELEGRA WITH SIESCAPE FEATURE K961833 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 1996. https://www.510kdatabase.net/k962178/ 1996-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k962178-bard-tiger-guidewire-model-000540-fda-510k.jpg K962178 - BARD TIGER GUIDEWIRE MODEL 000540 K962178 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 1996. https://www.510kdatabase.net/k962269/ 1996-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k962269-cedia-cardiac-tdm-multi-cals-fda-510k.jpg K962269 - CEDIA CARDIAC TDM MULTI-CALS K962269 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Oct 1996. https://www.510kdatabase.net/k962892/ 1996-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k962892-helax-tms-brachytherapy-version-30-fda-510k.jpg K962892 - HELAX TMS BRACHYTHERAPY, VERSION 3.0 K962892 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 1996. https://www.510kdatabase.net/k963306/ 1996-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k963306-cedia-n-acetylprocainamide-assay-fda-510k.jpg K963306 - CEDIA N-ACETYLPROCAINAMIDE ASSAY K963306 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Oct 1996. https://www.510kdatabase.net/k963378/ 1996-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k963378-medline-economy-limb-holderdeluxe-limb-fda-510k.jpg K963378 - MEDLINE ECONOMY LIMB HOLDER,DELUXE LIMB HOLDER,CINCH-TYPE LIMB HOLDER,PADDED LIMB HOLDER,ADJUSTABLE LIMB HOLDER K963378 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Oct 1996. https://www.510kdatabase.net/k963533/ 1996-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k963533-sigma-diagnostic-cx-3-calibration-fda-510k.jpg K963533 - SIGMA DIAGNOSTIC CX -3 CALIBRATION STANDARD LEVEL 1 K963533 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Oct 1996. https://www.510kdatabase.net/k960299/ 1996-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k960299-pyramid-trocar-10mm-wspring-ret-fda-510k.jpg K960299 - PYRAMID TROCAR, 10MM W/SPRING RET. PROTECTIVE SLEEVE OR TROCAR W/SPRING LOADED PROTECTION SLEEVE K960299 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Oct 1996. https://www.510kdatabase.net/k961341/ 1996-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k961341-convertors-polyolefin-fabric-gowns-fda-510k.jpg K961341 - CONVERTORS POLYOLEFIN FABRIC GOWNS K961341 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Oct 1996. https://www.510kdatabase.net/k961432/ 1996-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k961432-radias-galt-test-fda-510k.jpg K961432 - RADIAS GALT TEST K961432 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Oct 1996. https://www.510kdatabase.net/k960159/ 1996-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k960159-cordis-straight-or-finned-ventr-cath-fda-510k.jpg K960159 - CORDIS STRAIGHT OR FINNED VENTR CATH (W/RADIO DOTS) K960159 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cordis Corp.. Cleared Oct 1996. https://www.510kdatabase.net/k960571/ 1996-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k960571-rapid-electrophoresis-analyzer-fda-510k.jpg K960571 - RAPID ELECTROPHORESIS ANALYZER K960571 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Oct 1996. https://www.510kdatabase.net/k962925/ 1996-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k962925-olympus-b-5b-7-seriesballoon-catheter-fda-510k.jpg K962925 - OLYMPUS B-5/B-7 SERIESBALLOON CATHETER K962925 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus America, Inc.. Cleared Oct 1996. https://www.510kdatabase.net/k962932/ 1996-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k962932-cordis-stabilizer-plus-xs-fda-510k.jpg K962932 - CORDIS STABILIZER PLUS XS K962932 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Oct 1996. https://www.510kdatabase.net/k963329/ 1996-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k963329-ethicon-endosuture-system-fda-510k.jpg K963329 - ETHICON ENDOSUTURE SYSTEM K963329 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Oct 1996. https://www.510kdatabase.net/k963619/ 1996-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k963619-gore-tex-soft-tissue-patchmycromesha-fda-510k.jpg K963619 - GORE-TEX SOFT TISSUE PATCH,MYCROMESHA BIOMATERIAL,DUALMESH BIOMATERIAL,DUALMESH BIOMATERIAL WITH HOLES K963619 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Oct 1996. https://www.510kdatabase.net/k955553/ 1996-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k955553-perfecta-revision-hip-system-fda-510k.jpg K955553 - PERFECTA REVISION HIP SYSTEM K955553 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Oct 1996. https://www.510kdatabase.net/k963537/ 1996-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k963537-sigma-diagnostics-bun-reagent-fda-510k.jpg K963537 - SIGMA DIAGNOSTICS BUN REAGENT K963537 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Oct 1996. https://www.510kdatabase.net/k963541/ 1996-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k963541-sigma-diagnostics-co2-acid-reagent-fda-510k.jpg K963541 - SIGMA DIAGNOSTICS CO2 ACID REAGENT K963541 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Oct 1996. https://www.510kdatabase.net/k963627/ 1996-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k963627-modified-version-integra-ion-selective-fda-510k.jpg K963627 - (MODIFIED VERSION) INTEGRA ION SELECTIVE ELECTRODE (ISE) MODULE K963627 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Oct 1996. https://www.510kdatabase.net/k960056/ 1996-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k960056-usci-pro-flo-xtsoft-tip-and-xt-soft-fda-510k.jpg K960056 - USCI PRO FLO XT,SOFT TIP, AND XT SOFT TIP ANGIOGRAPHIC K960056 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 1996. https://www.510kdatabase.net/k962907/ 1996-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k962907-skinnyfranseenwescott-needles-fda-510k.jpg K962907 - SKINNY,FRANSEEN,WESCOTT NEEDLES K962907 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Oct 1996. https://www.510kdatabase.net/k962945/ 1996-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k962945-cordis-opta-pta-balloon-catheter-fda-510k.jpg K962945 - CORDIS OPTA PTA BALLOON CATHETER K962945 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Oct 1996. https://www.510kdatabase.net/k963213/ 1996-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k963213-boehringer-mannheim-direct-hdl-fda-510k.jpg K963213 - BOEHRINGER MANNHEIM DIRECT HDL-CHOLESTEROL K963213 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Oct 1996. https://www.510kdatabase.net/k954651/ 1996-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k954651-electrode-recording-catheter-fda-510k.jpg K954651 - ELECTRODE RECORDING CATHETER K954651 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Oct 1996. https://www.510kdatabase.net/k962409/ 1996-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k962409-olympus-c3-immunoturbidimetric-regent-fda-510k.jpg K962409 - OLYMPUS C3 IMMUNOTURBIDIMETRIC REGENT K962409 is a FDA 510(k) cleared immunology medical device. Manufacturer: Olympus America, Inc.. Cleared Oct 1996. https://www.510kdatabase.net/k962582/ 1996-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k962582-olympus-c4-immunoturbidimetric-reagent-fda-510k.jpg K962582 - OLYMPUS C4 IMMUNOTURBIDIMETRIC REAGENT K962582 is a FDA 510(k) cleared immunology medical device. Manufacturer: Olympus America, Inc.. Cleared Oct 1996. https://www.510kdatabase.net/k962893/ 1996-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k962893-interlink-adapter-for-conventional-y-fda-510k.jpg K962893 - INTERLINK ADAPTER FOR CONVENTIONAL Y-SITE K962893 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Oct 1996. https://www.510kdatabase.net/k963345/ 1996-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k963345-advantage-windows-tissue-volume-option-fda-510k.jpg K963345 - ADVANTAGE WINDOWS TISSUE VOLUME OPTION K963345 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Oct 1996. https://www.510kdatabase.net/k963360/ 1996-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k963360-medline-body-holder-fda-510k.jpg K963360 - MEDLINE BODY HOLDER K963360 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Oct 1996. https://www.510kdatabase.net/k963362/ 1996-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k963362-medline-saety-vestmedline-economy-vest-fda-510k.jpg K963362 - MEDLINE SAETY VEST,MEDLINE ECONOMY VEST, MEDLINE TIE-BACK VEST, MEDLINE SECURTIY VEST, VEST RESTRAINT K963362 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Oct 1996. https://www.510kdatabase.net/k963404/ 1996-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k963404-medline-pelvic-holder-fda-510k.jpg K963404 - MEDLINE PELVIC HOLDER K963404 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Oct 1996. https://www.510kdatabase.net/k963569/ 1996-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k963569-wheelchair-waist-belt-medline-economy-fda-510k.jpg K963569 - WHEELCHAIR WAIST BELT, MEDLINE ECONOMY WHEELCHAIR BELT, MEDLINE TWO-PIECE SAFETY SOFT BELT, MEDLINE WHEELCHAIR BELT WITH K963569 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Oct 1996. https://www.510kdatabase.net/k962830/ 1996-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k962830-vista-brite-tip-catheters-fda-510k.jpg K962830 - VISTA BRITE TIP CATHETERS K962830 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Oct 1996. https://www.510kdatabase.net/k963206/ 1996-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k963206-s-rom-hip-system-locking-plug-fda-510k.jpg K963206 - S-ROM HIP SYSTEM - LOCKING PLUG K963206 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Oct 1996. https://www.510kdatabase.net/k960074/ 1996-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k960074-capiox-sx10-hollow-fiber-oxygenator-fda-510k.jpg K960074 - CAPIOX SX10 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL VENOUS RESERVOIR K960074 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Oct 1996. https://www.510kdatabase.net/k955712/ 1996-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k955712-usci-bipolar-balloon-pacing-electrode-fda-510k.jpg K955712 - USCI BIPOLAR BALLOON PACING ELECTRODE WITH BH COATING K955712 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 1996. https://www.510kdatabase.net/k962746/ 1996-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k962746-cordis-avanti-trans-radial-catheter-fda-510k.jpg K962746 - CORDIS AVANTI TRANS-RADIAL CATHETER SHEATH INTRODUCER KIT K962746 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Oct 1996. https://www.510kdatabase.net/k962761/ 1996-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k962761-reigel-tunneling-device-fda-510k.jpg K962761 - REIGEL TUNNELING DEVICE K962761 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cook, Inc.. Cleared Oct 1996. https://www.510kdatabase.net/k963538/ 1996-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k963538-sigma-diagnostics-co2alkaline-buffer-fda-510k.jpg K963538 - SIGMA DIAGNOSTICS CO2ALKALINE BUFFER K963538 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Oct 1996. https://www.510kdatabase.net/k954481/ 1996-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k954481-pfc-uni-compartmental-knee-system-fda-510k.jpg K954481 - P.F.C. UNI-COMPARTMENTAL KNEE SYSTEM K954481 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Oct 1996. https://www.510kdatabase.net/k961165/ 1996-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k961165-hp-m2600a-omnicare-telemetry-system-fda-510k.jpg K961165 - HP M2600A OMNICARE TELEMETRY SYSTEM MODEL M2600A K961165 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Oct 1996. https://www.510kdatabase.net/k961228/ 1996-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k961228-karl-storz-magnifying-arthrosocpes-fda-510k.jpg K961228 - KARL STORZ MAGNIFYING ARTHROSOCPES K961228 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Oct 1996. https://www.510kdatabase.net/k961889/ 1996-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k961889-specific-allergen-modules-and-mixed-fda-510k.jpg K961889 - SPECIFIC ALLERGEN MODULES AND MIXED ALLERGEN PANELS FOR ALASTAT MICROPLATE AND ALASTAT EIA ALLERGEN-SPECIFIC IGE SYSTEMS K961889 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Oct 1996. https://www.510kdatabase.net/k962738/ 1996-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k962738-millennium-mt-and-millennium-mg-fda-510k.jpg K962738 - MILLENNIUM MT AND MILLENNIUM MG NUCLEAR MEDICINE SYSTEMS K962738 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Oct 1996. https://www.510kdatabase.net/k962759/ 1996-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k962759-4f-nylex-angiographic-catheter-fda-510k.jpg K962759 - 4F NYLEX ANGIOGRAPHIC CATHETER K962759 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Oct 1996. https://www.510kdatabase.net/k963390/ 1996-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k963390-biopsy-introducer-needle-fda-510k.jpg K963390 - BIOPSY INTRODUCER NEEDLE K963390 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Oct 1996. https://www.510kdatabase.net/k963398/ 1996-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k963398-alta-fully-threaded-cross-locking-screws-fda-510k.jpg K963398 - ALTA FULLY THREADED CROSS-LOCKING SCREWS K963398 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Oct 1996. https://www.510kdatabase.net/k963536/ 1996-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k963536-sigma-diagnostics-calicium-reagent-fda-510k.jpg K963536 - SIGMA DIAGNOSTICS CALICIUM REAGENT K963536 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Oct 1996. https://www.510kdatabase.net/k961841/ 1996-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k961841-bard-v-max-roller-bar-3551xx-fda-510k.jpg K961841 - BARD V-MAX ROLLER BAR (3551XX K961841 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 1996. https://www.510kdatabase.net/k962921/ 1996-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k962921-bard-a-trac-urological-balloon-fda-510k.jpg K962921 - BARD A-TRAC UROLOGICAL BALLOON DILATION CATHETER K962921 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 1996. https://www.510kdatabase.net/k963084/ 1996-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k963084-opus-cmv-test-system-modification-fda-510k.jpg K963084 - OPUS CMV TEST SYSTEM-MODIFICATION K963084 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Oct 1996. https://www.510kdatabase.net/k955715/ 1996-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k955715-cell-dyn-3500-multi-parameter-fda-510k.jpg K955715 - CELL DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (MODIFICATION) K955715 is a FDA 510(k) cleared hematology medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1996. https://www.510kdatabase.net/k955877/ 1996-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k955877-zimmer-zirconia-ceramic-femoral-head-fda-510k.jpg K955877 - ZIMMER ZIRCONIA CERAMIC FEMORAL HEAD K955877 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Oct 1996. https://www.510kdatabase.net/k961378/ 1996-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k961378-delta-hip-prosthesis-fda-510k.jpg K961378 - DELTA HIP PROSTHESIS K961378 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Oct 1996. https://www.510kdatabase.net/k961401/ 1996-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k961401-hp-cathstation-model-m1264b-fda-510k.jpg K961401 - HP CATHSTATION - MODEL M1264B K961401 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Oct 1996. https://www.510kdatabase.net/k963253/ 1996-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k963253-synthetic-absorbable-surgical-suture-fda-510k.jpg K963253 - SYNTHETIC ABSORBABLE SURGICAL SUTURE K963253 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Oct 1996. https://www.510kdatabase.net/k963499/ 1996-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k963499-mirror-finish-bipolar-forceps-fda-510k.jpg K963499 - MIRROR FINISH BIPOLAR FORCEPS K963499 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Oct 1996. https://www.510kdatabase.net/k962411/ 1996-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k962411-ontrak-testcup-amphetamines-fda-510k.jpg K962411 - ONTRAK TESTCUP AMPHETAMINES K962411 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Oct 1996. https://www.510kdatabase.net/k962667/ 1996-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k962667-capiox-sx25-hollow-fiber-oxygenator-fda-510k.jpg K962667 - CAPIOX SX25 HOLLOW FIBER OXYGENATOR WITH DETACHABLE HARDSHELL RESERVOIR K962667 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Oct 1996. https://www.510kdatabase.net/k962812/ 1996-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k962812-gluma-desensitizergluma-3-primer-fda-510k.jpg K962812 - GLUMA DESENSITIZER/GLUMA 3 PRIMER K962812 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Oct 1996. https://www.510kdatabase.net/k963286/ 1996-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k963286-immage-immunochemistry-system-fda-510k.jpg K963286 - IMMAGE IMMUNOCHEMISTRY SYSTEM HAPTOGLOBIN (HPT) REAGENT K963286 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Oct 1996. https://www.510kdatabase.net/k963427/ 1996-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k963427-immage-immunochemistry-system-fda-510k.jpg K963427 - IMMAGE IMMUNOCHEMISTRY SYSTEM TRANSFERRIN (TRF) REAGENT K963427 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Oct 1996. https://www.510kdatabase.net/k955596/ 1996-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k955596-n-latex-b2-microglobulin-reagent-fda-510k.jpg K955596 - N LATEX B2-MICROGLOBULIN REAGENT K955596 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Oct 1996. https://www.510kdatabase.net/k961091/ 1996-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k961091-karl-storz-model-203020-20-equimat-fda-510k.jpg K961091 - KARL STORZ MODEL 203020 20 EQUIMAT K961091 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Oct 1996. https://www.510kdatabase.net/k962624/ 1996-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k962624-resolut-regenerative-material-fda-510k.jpg K962624 - RESOLUT REGENERATIVE MATERIAL K962624 is a FDA 510(k) cleared dental medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Oct 1996. https://www.510kdatabase.net/k953983/ 1996-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k953983-evap-electrodes-types-8423-8427-8410-fda-510k.jpg K953983 - EVAP-ELECTRODES TYPES 8423, 8427, 8410 & 8413 ELECTROSURGICAL VAPORIZATION OF SOFT TISSUE K953983 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Oct 1996. https://www.510kdatabase.net/k961000/ 1996-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k961000-capiox-sx18-hollow-fiber-oxygenator-fda-510k.jpg K961000 - CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH AND WITHOUT DETACHABLE HARDSHELL RESERVOIR K961000 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Oct 1996. https://www.510kdatabase.net/k963113/ 1996-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k963113-flexiflo-polyg-gastostomy-tube-fda-510k.jpg K963113 - FLEXIFLO POLYG GASTOSTOMY TUBE K963113 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1996. https://www.510kdatabase.net/k963200/ 1996-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k963200-questus-polyester-suture-soft-tissue-fda-510k.jpg K963200 - QUESTUS POLYESTER SUTURE SOFT TISSUE ANCHOR SYSTEM K963200 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Oct 1996. https://www.510kdatabase.net/k963217/ 1996-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k963217-anchorlok-ii-soft-tissue-anchor-system-fda-510k.jpg K963217 - ANCHORLOK II SOFT TISSUE ANCHOR SYSTEM K963217 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Oct 1996. https://www.510kdatabase.net/k961107/ 1996-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k961107-b-braun-guidewires-fda-510k.jpg K961107 - B. BRAUN GUIDEWIRES K961107 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Oct 1996. https://www.510kdatabase.net/k961304/ 1996-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k961304-aura-hip-system-cemented-femoral-fda-510k.jpg K961304 - AURA HIP SYSTEM CEMENTED FEMORAL STEM/CEMENTED LONG FEMORAL STEM K961304 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Oct 1996. https://www.510kdatabase.net/k962823/ 1996-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k962823-synthes-sterile-30-mm-cannulated-screw-fda-510k.jpg K962823 - SYNTHES STERILE 3.0 MM CANNULATED SCREW AND THREADED WASHER K962823 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Oct 1996. https://www.510kdatabase.net/k962923/ 1996-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k962923-depuy-graded-porosity-aml-hip-1371-fda-510k.jpg K962923 - DEPUY GRADED POROSITY AML HIP (1371-03/06-500/1371-43/46-500) K962923 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Oct 1996. https://www.510kdatabase.net/k963040/ 1996-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k963040-manual-phenylalanine-test-fda-510k.jpg K963040 - MANUAL PHENYLALANINE TEST K963040 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Oct 1996. https://www.510kdatabase.net/k953930/ 1996-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k953930-virtuoso-smart-cpap-system-fda-510k.jpg K953930 - VIRTUOSO SMART CPAP SYSTEM K953930 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Sep 1996. https://www.510kdatabase.net/k962090/ 1996-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k962090-karl-storz-model-203210-o1-unimat-plus-fda-510k.jpg K962090 - KARL STORZ MODEL 203210 O1 UNIMAT PLUS K962090 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Sep 1996. https://www.510kdatabase.net/k963534/ 1996-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k963534-sigma-diagnostics-creatinine-reagent-kit-fda-510k.jpg K963534 - SIGMA DIAGNOSTICS CREATININE REAGENT KIT K963534 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Sep 1996. https://www.510kdatabase.net/k961674/ 1996-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k961674-roche-unimate-fructosamine-reagent-fda-510k.jpg K961674 - ROCHE UNIMATE FRUCTOSAMINE REAGENT K961674 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Sep 1996. https://www.510kdatabase.net/k963540/ 1996-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k963540-sigma-diagnostics-electrolyte-buffer-fda-510k.jpg K963540 - SIGMA DIAGNOSTICS ELECTROLYTE BUFFER K963540 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Sep 1996. https://www.510kdatabase.net/k963542/ 1996-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k963542-sigma-diagostic-electrolyte-reference-fda-510k.jpg K963542 - SIGMA DIAGOSTIC ELECTROLYTE REFERENCE REAGENT K963542 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Sep 1996. https://www.510kdatabase.net/k962198/ 1996-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k962198-quantex-c4-fda-510k.jpg K962198 - QUANTEX C4 K962198 is a FDA 510(k) cleared immunology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 1996. https://www.510kdatabase.net/k962202/ 1996-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k962202-quantex-igg-fda-510k.jpg K962202 - QUANTEX IGG K962202 is a FDA 510(k) cleared immunology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 1996. https://www.510kdatabase.net/k961771/ 1996-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k961771-auto-suture-surgiwand-fda-510k.jpg K961771 - AUTO SUTURE SURGIWAND K961771 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Sep 1996. https://www.510kdatabase.net/k962199/ 1996-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k962199-quantex-c3-fda-510k.jpg K962199 - QUANTEX C3 K962199 is a FDA 510(k) cleared immunology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 1996. https://www.510kdatabase.net/k962200/ 1996-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k962200-quantex-iga-fda-510k.jpg K962200 - QUANTEX IGA K962200 is a FDA 510(k) cleared immunology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 1996. https://www.510kdatabase.net/k962201/ 1996-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k962201-quantex-igm-fda-510k.jpg K962201 - QUANTEX IGM K962201 is a FDA 510(k) cleared immunology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 1996. https://www.510kdatabase.net/k962561/ 1996-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k962561-supracondylar-intramedullary-nail-fda-510k.jpg K962561 - SUPRACONDYLAR INTRAMEDULLARY NAIL K962561 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Sep 1996. https://www.510kdatabase.net/k962927/ 1996-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k962927-in-room-mrc-magnetom-vision-and-impact-fda-510k.jpg K962927 - IN-ROOM MRC/ MAGNETOM VISION AND IMPACT SYSTEMS K962927 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 1996. https://www.510kdatabase.net/k954045/ 1996-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k954045-axsym-rubella-igg-antibody-assay-fda-510k.jpg K954045 - AXSYM RUBELLA IGG ANTIBODY ASSAY K954045 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1996. https://www.510kdatabase.net/k962043/ 1996-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k962043-auto-suture-modified-vcs-clip-applier-fda-510k.jpg K962043 - AUTO SUTURE MODIFIED VCS CLIP APPLIER K962043 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Sep 1996. https://www.510kdatabase.net/k953943/ 1996-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k953943-axsym-cmv-igg-antibody-assay-fda-510k.jpg K953943 - AXSYM CMV IGG ANTIBODY ASSAY K953943 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1996. https://www.510kdatabase.net/k960087/ 1996-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k960087-soribie-resurfacing-total-elbow-system-fda-510k.jpg K960087 - SORIBIE RESURFACING TOTAL ELBOW SYSTEM (PROPOSED NAME) K960087 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Sep 1996. https://www.510kdatabase.net/k960865/ 1996-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k960865-step-option-to-prism-2000-fda-510k.jpg K960865 - STEP OPTION TO PRISM 2000 K960865 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Sep 1996. https://www.510kdatabase.net/k962896/ 1996-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k962896-kodak-digital-science-remote-cassette-fda-510k.jpg K962896 - KODAK DIGITAL SCIENCE REMOTE CASSETTE K962896 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Sep 1996. https://www.510kdatabase.net/k963252/ 1996-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k963252-tban-fda-510k.jpg K963252 - TBAN K963252 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Boston Scientific Corp. Cleared Sep 1996. https://www.510kdatabase.net/k960674/ 1996-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k960674-contrast-injection-lines-fda-510k.jpg K960674 - CONTRAST INJECTION LINES K960674 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Sep 1996. https://www.510kdatabase.net/k962429/ 1996-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k962429-safety-vest-fda-510k.jpg K962429 - SAFETY VEST K962429 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Sep 1996. https://www.510kdatabase.net/k952660/ 1996-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k952660-braun-hemodialysis-catheter-fda-510k.jpg K952660 - BRAUN HEMODIALYSIS CATHETER K952660 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Sep 1996. https://www.510kdatabase.net/k960984/ 1996-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k960984-shp-hip-system-femoral-fda-510k.jpg K960984 - SHP HIP SYSTEM-FEMORAL COMPONENTS/ACETABULAR COMPONENTS/MODULAR HEADS/CENTRALIZERS K960984 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Sep 1996. https://www.510kdatabase.net/k961186/ 1996-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k961186-depuy-duraloc-cementless-acetabular-fda-510k.jpg K961186 - DEPUY DURALOC CEMENTLESS ACETABULAR CUP SYSTEM K961186 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Sep 1996. https://www.510kdatabase.net/k961239/ 1996-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k961239-depuy-sterile-view-barrier-hoodgown-fda-510k.jpg K961239 - DEPUY STERILE VIEW BARRIER HOOD/GOWN WITH HYTREL K961239 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Depuy, Inc.. Cleared Sep 1996. https://www.510kdatabase.net/k961572/ 1996-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k961572-versalok-screw-assembly-proposed-name-fda-510k.jpg K961572 - VERSALOK SCREW ASSEMBLY (PROPOSED NAME) K961572 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Sep 1996. https://www.510kdatabase.net/k961745/ 1996-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k961745-braun-percutaneous-introducer-set-fda-510k.jpg K961745 - BRAUN PERCUTANEOUS INTRODUCER SET K961745 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Sep 1996. https://www.510kdatabase.net/k962393/ 1996-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k962393-ksea-set-for-endoscopic-assisted-fda-510k.jpg K962393 - KSEA SET FOR ENDOSCOPIC ASSISTED INTUBATION K962393 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Sep 1996. https://www.510kdatabase.net/k962467/ 1996-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k962467-rv-pacing-lead-fda-510k.jpg K962467 - RV PACING LEAD K962467 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1996. https://www.510kdatabase.net/k961048/ 1996-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k961048-olympus-mh-246r-balloon-sheath-fda-510k.jpg K961048 - OLYMPUS MH-246R BALLOON SHEATH K961048 is a FDA 510(k) cleared radiology medical device. Manufacturer: Olympus America, Inc.. Cleared Sep 1996. https://www.510kdatabase.net/k961941/ 1996-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k961941-liquichek-immunoassay-plus-control-fda-510k.jpg K961941 - LIQUICHEK IMMUNOASSAY PLUS CONTROL CATALOG NO. 360,361,362,363 K961941 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Sep 1996. https://www.510kdatabase.net/k962826/ 1996-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k962826-medline-radiology-diagnostic-kits-fda-510k.jpg K962826 - MEDLINE RADIOLOGY-DIAGNOSTIC KITS K962826 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medline Industries, Inc.. Cleared Sep 1996. https://www.510kdatabase.net/k955002/ 1996-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k955002-mahurkar-8-fr-dual-lemen-catheter-fda-510k.jpg K955002 - MAHURKAR 8 FR DUAL LEMEN CATHETER K955002 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quinton, Inc.. Cleared Sep 1996. https://www.510kdatabase.net/k960192/ 1996-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k960192-positron-coincidence-detection-fda-510k.jpg K960192 - POSITRON COINCIDENCE DETECTION K960192 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Sep 1996. https://www.510kdatabase.net/k962493/ 1996-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k962493-endoscopic-clip-applier-fda-510k.jpg K962493 - ENDOSCOPIC CLIP APPLIER K962493 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Aesculap, Inc.. Cleared Sep 1996. https://www.510kdatabase.net/k960875/ 1996-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k960875-kc-40-micro-coagulation-analyzer-fda-510k.jpg K960875 - KC 40 MICRO COAGULATION ANALYZER SYSTEM (K3632) K960875 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Sep 1996. https://www.510kdatabase.net/k962267/ 1996-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k962267-perfecta-ps-revision-stem-fda-510k.jpg K962267 - PERFECTA PS REVISION STEM K962267 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Sep 1996. https://www.510kdatabase.net/k963158/ 1996-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k963158-abbott-axsym-digitoxin-modify-fda-510k.jpg K963158 - ABBOTT AXSYM DIGITOXIN (MODIFY) K963158 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1996. https://www.510kdatabase.net/k963181/ 1996-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k963181-elecsys-calcheck-t-update-fda-510k.jpg K963181 - ELECSYS CALCHECK T UPDATE K963181 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Sep 1996. https://www.510kdatabase.net/k963191/ 1996-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k963191-cedia-antibiotic-tdm-multi-cals-fda-510k.jpg K963191 - CEDIA ANTIBIOTIC TDM MULTI-CALS K963191 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Sep 1996. https://www.510kdatabase.net/k963033/ 1996-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k963033-bf-240p240it240-bronchovideoscope-fda-510k.jpg K963033 - BF 240/P240/IT240 BRONCHOVIDEOSCOPE & ACCESSORIES K963033 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Olympus America, Inc.. Cleared Sep 1996. https://www.510kdatabase.net/k961628/ 1996-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k961628-mini-flex-coil-fda-510k.jpg K961628 - MINI FLEX COIL K961628 is a FDA 510(k) cleared radiology medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Sep 1996. https://www.510kdatabase.net/k962484/ 1996-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k962484-synthes-titanium-external-fixator-fda-510k.jpg K962484 - SYNTHES TITANIUM EXTERNAL FIXATOR CLAMPS (TI EFC) K962484 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Sep 1996. https://www.510kdatabase.net/k961991/ 1996-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k961991-acl-6000-system-acl-6000-fda-510k.jpg K961991 - ACL 6000 SYSTEM (ACL 6000) K961991 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 1996. https://www.510kdatabase.net/k962177/ 1996-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k962177-bard-taperseal-intra-aortic-balloon-fda-510k.jpg K962177 - BARD TAPERSEAL INTRA-AORTIC BALLOON CATHETER & INTRODUCER KIT K962177 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Sep 1996. https://www.510kdatabase.net/k962375/ 1996-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k962375-microvasive-balloon-gastrostomy-tube-kit-fda-510k.jpg K962375 - MICROVASIVE BALLOON GASTROSTOMY TUBE KIT K962375 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Sep 1996. https://www.510kdatabase.net/k962519/ 1996-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k962519-emit-2000-gentamicin-assay-and-fda-510k.jpg K962519 - EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS K962519 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Sep 1996. https://www.510kdatabase.net/k962595/ 1996-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k962595-karl-storz-xenon-300-light-source-for-fda-510k.jpg K962595 - KARL STORZ XENON 300 LIGHT SOURCE FOR NON-FLASH APPLICATIONS K962595 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Sep 1996. https://www.510kdatabase.net/k962401/ 1996-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k962401-gore-tex-dualmesh-plus-biomaterial-fda-510k.jpg K962401 - GORE-TEX DUALMESH PLUS BIOMATERIAL WITH HOLES K962401 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Sep 1996. https://www.510kdatabase.net/k962616/ 1996-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k962616-synthes-dorsal-distal-radius-plate-fda-510k.jpg K962616 - SYNTHES DORSAL DISTAL RADIUS PLATE (DDRP) SYSTEM K962616 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Sep 1996. https://www.510kdatabase.net/k963093/ 1996-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k963093-siremobil-compact-fda-510k.jpg K963093 - SIREMOBIL COMPACT K963093 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 1996. https://www.510kdatabase.net/k962231/ 1996-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k962231-cobas-core-immunochemistry-system-fda-510k.jpg K962231 - COBAS CORE IMMUNOCHEMISTRY SYSTEM K962231 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Aug 1996. https://www.510kdatabase.net/k962272/ 1996-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k962272-synthes-mandible-distractor-fda-510k.jpg K962272 - SYNTHES MANDIBLE DISTRACTOR K962272 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Aug 1996. https://www.510kdatabase.net/k963165/ 1996-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k963165-elecsys-calcheck-hcg-fda-510k.jpg K963165 - ELECSYS CALCHECK HCG K963165 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Aug 1996. https://www.510kdatabase.net/k961860/ 1996-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k961860-a4907-lens-cleaning-sheath-fda-510k.jpg K961860 - A4907 LENS CLEANING SHEATH K961860 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Olympus America, Inc.. Cleared Aug 1996. https://www.510kdatabase.net/k962097/ 1996-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k962097-ventricular-catheter-set-fda-510k.jpg K962097 - VENTRICULAR CATHETER SET K962097 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cook, Inc.. Cleared Aug 1996. https://www.510kdatabase.net/k962248/ 1996-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k962248-pfc-ceramic-hip-head-fda-510k.jpg K962248 - P.F.C. CERAMIC HIP HEAD K962248 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Aug 1996. https://www.510kdatabase.net/k962975/ 1996-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k962975-prostate-specific-antigen-rsa-control-fda-510k.jpg K962975 - PROSTATE SPECIFIC ANTIGEN (RSA) CONTROL MODDULE (PSACM) K962975 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Aug 1996. https://www.510kdatabase.net/k963240/ 1996-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k963240-immulite-acth-control-module-laccm-fda-510k.jpg K963240 - IMMULITE ACTH CONTROL MODULE (LACCM) K963240 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Aug 1996. https://www.510kdatabase.net/k960700/ 1996-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k960700-logiq-a200-diagnostic-ultrasound-system-fda-510k.jpg K960700 - LOGIQ A200 DIAGNOSTIC ULTRASOUND SYSTEM K960700 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Aug 1996. https://www.510kdatabase.net/k962581/ 1996-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k962581-stopcock-manifold-gangs-fda-510k.jpg K962581 - STOPCOCK MANIFOLD GANGS K962581 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Aug 1996. https://www.510kdatabase.net/k962099/ 1996-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k962099-cedia-procainamide-assay-fda-510k.jpg K962099 - CEDIA PROCAINAMIDE ASSAY K962099 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Aug 1996. https://www.510kdatabase.net/k962117/ 1996-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k962117-quadrature-and-phased-array-flexible-fda-510k.jpg K962117 - QUADRATURE AND PHASED ARRAY FLEXIBLE BODY COILS K962117 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Aug 1996. https://www.510kdatabase.net/k962396/ 1996-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k962396-ksea-bipolar-goagulating-forceps-fda-510k.jpg K962396 - KSEA BIPOLAR GOAGULATING FORCEPS K962396 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Aug 1996. https://www.510kdatabase.net/k962397/ 1996-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k962397-statak-soft-tissue-attachment-device-fda-510k.jpg K962397 - STATAK SOFT TISSUE ATTACHMENT DEVICE K962397 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Aug 1996. https://www.510kdatabase.net/k962898/ 1996-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k962898-ksea-unimat-plus-fda-510k.jpg K962898 - KSEA UNIMAT PLUS K962898 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Aug 1996. https://www.510kdatabase.net/k963163/ 1996-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k963163-elecsys-calcheck-ft3-fda-510k.jpg K963163 - ELECSYS CALCHECK FT3 K963163 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Aug 1996. https://www.510kdatabase.net/k963164/ 1996-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k963164-elecsys-calcheck-ft4-fda-510k.jpg K963164 - ELECSYS CALCHECK FT4 K963164 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Aug 1996. https://www.510kdatabase.net/k963167/ 1996-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k963167-elecys-calcheck-t-3-fda-510k.jpg K963167 - ELECYS CALCHECK T 3 K963167 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Aug 1996. https://www.510kdatabase.net/k963178/ 1996-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k963178-elecsys-calcheck-t4-fda-510k.jpg K963178 - ELECSYS CALCHECK T4 K963178 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Aug 1996. https://www.510kdatabase.net/k954576/ 1996-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k954576-axsym-toxo-igm-fda-510k.jpg K954576 - AXSYM TOXO IGM K954576 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1996. https://www.510kdatabase.net/k961699/ 1996-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k961699-equipment-covers-fda-510k.jpg K961699 - EQUIPMENT COVERS K961699 is a FDA 510(k) cleared general hospital medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Aug 1996. https://www.510kdatabase.net/k962076/ 1996-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k962076-medline-pwder-free-vibnyl-examiunation-fda-510k.jpg K962076 - MEDLINE PWDER-FREE VIBNYL EXAMIUNATION GLOVES/VINYL GLOVES, STERILE (MDS 192074,5,6) K962076 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Aug 1996. https://www.510kdatabase.net/k962094/ 1996-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k962094-medline-pre-powdered-non-sterile-and-fda-510k.jpg K962094 - MEDLINE PRE-POWDERED NON-STERILE AND STERILE LATEX EXAMINATION GLOVES K962094 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Aug 1996. https://www.510kdatabase.net/k962095/ 1996-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k962095-medline-powder-free-non-sterile-latex-fda-510k.jpg K962095 - MEDLINE POWDER-FREE NON-STERILE LATEX EXAMINATION GLOVES,MEDLINE POWDER-FREE STERILE LATEX EXAMINATION GLOVES K962095 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Aug 1996. https://www.510kdatabase.net/k962196/ 1996-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k962196-nexgen-knee-prosthesis-legacy-knee-fda-510k.jpg K962196 - NEXGEN KNEE PROSTHESIS & LEGACY KNEE PROSTHESIS W/CO-NIDIUM SURFACE HARDENING PROCESS K962196 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Aug 1996. https://www.510kdatabase.net/k962866/ 1996-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k962866-opus-hlh-fda-510k.jpg K962866 - OPUS HLH K962866 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Aug 1996. https://www.510kdatabase.net/k963143/ 1996-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k963143-elecsys-calcheck-troponin-t-fda-510k.jpg K963143 - ELECSYS CALCHECK TROPONIN T K963143 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Aug 1996. https://www.510kdatabase.net/k963147/ 1996-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k963147-elecsys-calcheck-tsh-fda-510k.jpg K963147 - ELECSYS CALCHECK TSH K963147 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Aug 1996. https://www.510kdatabase.net/k963182/ 1996-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k963182-elecsys-calcheck-ck-mb-fda-510k.jpg K963182 - ELECSYS CALCHECK CK-MB K963182 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Aug 1996. https://www.510kdatabase.net/k960903/ 1996-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k960903-karl-storz-inst-for-endoscopic-fda-510k.jpg K960903 - KARL STORZ INST. FOR ENDOSCOPIC SELECTIVE PERF. VEIN DISCISSION & PARATIBIAL FASCIOTOMY K960903 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Aug 1996. https://www.510kdatabase.net/k962036/ 1996-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k962036-medtronic-model-5058-bipolar-fda-510k.jpg K962036 - MEDTRONIC MODEL 5058 BIPOLAR, IMPLANTABLE, SCREW-IN, VENTRICULAR/ATRIAL, TRANSVENOUS LEAD K962036 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Aug 1996. https://www.510kdatabase.net/k962241/ 1996-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k962241-gore-spherex-implant-fda-510k.jpg K962241 - GORE SPHEREX IMPLANT K962241 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Aug 1996. https://www.510kdatabase.net/k962174/ 1996-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k962174-biplr-im-en-pac-leads-430-07432-03436-fda-510k.jpg K962174 - BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07) K962174 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Aug 1996. https://www.510kdatabase.net/k962294/ 1996-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k962294-immage-immunochemistry-system-fda-510k.jpg K962294 - IMMAGE IMMUNOCHEMISTRY SYSTEM K962294 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Aug 1996. https://www.510kdatabase.net/k962485/ 1996-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k962485-olympus-fg-series-of-rat-tooth-fda-510k.jpg K962485 - OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS (ENT) K962485 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Olympus America, Inc.. Cleared Aug 1996. https://www.510kdatabase.net/k962901/ 1996-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k962901-olympus-b5-2cb7-2c-balloon-catheter-fda-510k.jpg K962901 - OLYMPUS B5-2C/B7-2C BALLOON CATHETER K962901 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Olympus America, Inc.. Cleared Aug 1996. https://www.510kdatabase.net/k962069/ 1996-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k962069-medline-pre-powdered-non-fda-510k.jpg K962069 - MEDLINE PRE-POWDERED NON-STERILE/STERILE VINYL EXAMINATION GLOVES K962069 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Aug 1996. https://www.510kdatabase.net/k954575/ 1996-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k954575-axsym-toxo-igg-antibody-assay-fda-510k.jpg K954575 - AXSYM TOXO IGG ANTIBODY ASSAY K954575 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1996. https://www.510kdatabase.net/k960437/ 1996-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k960437-radias-phenylalanine-test-fda-510k.jpg K960437 - RADIAS PHENYLALANINE TEST K960437 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Aug 1996. https://www.510kdatabase.net/k962280/ 1996-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k962280-abuscreen-online-positive-control-15x-fda-510k.jpg K962280 - ABUSCREEN ONLINE POSITIVE CONTROL / 1.5X CALIBRATOR K962280 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Aug 1996. https://www.510kdatabase.net/k961915/ 1996-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k961915-spectrum-reusable-full-face-mask-size-fda-510k.jpg K961915 - SPECTRUM REUSABLE FULL FACE MASK - SIZE PETITE, SMALL, MEDIUM, LARGE K961915 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Aug 1996. https://www.510kdatabase.net/k961936/ 1996-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k961936-model-2188-coronary-sinus-lead-fda-510k.jpg K961936 - MODEL 2188 CORONARY SINUS LEAD. K961936 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Aug 1996. https://www.510kdatabase.net/k962161/ 1996-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k962161-baxter-nebulizer-cap-model-2d0868-fda-510k.jpg K962161 - BAXTER NEBULIZER CAP MODEL 2D0868 K962161 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Aug 1996. https://www.510kdatabase.net/k962508/ 1996-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k962508-elecsys-t3-fda-510k.jpg K962508 - ELECSYS T3 K962508 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Aug 1996. https://www.510kdatabase.net/k962841/ 1996-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k962841-opus-myoglobin-controls-fda-510k.jpg K962841 - OPUS MYOGLOBIN CONTROLS K962841 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Aug 1996. https://www.510kdatabase.net/k960656/ 1996-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k960656-gore-burr-hole-cover-fda-510k.jpg K960656 - GORE BURR HOLE COVER K960656 is a FDA 510(k) cleared neurology medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Aug 1996. https://www.510kdatabase.net/k962152/ 1996-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k962152-osteonics-scorpio-posteriorly-fda-510k.jpg K962152 - OSTEONICS SCORPIO POSTERIORLY STABILIZED TOTAL KNEE SYSTEM K962152 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Aug 1996. https://www.510kdatabase.net/k962162/ 1996-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k962162-dall-miles-trochanter-cable-supergrip-fda-510k.jpg K962162 - DALL-MILES TROCHANTER CABLE SUPERGRIP K962162 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Aug 1996. https://www.510kdatabase.net/k952614/ 1996-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k952614-jeltrate-plus-antimicrobial-impr-fda-510k.jpg K952614 - JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL K952614 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Aug 1996. https://www.510kdatabase.net/k961939/ 1996-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k961939-s-rom-femoral-hip-stemsizes-12-x-06-x-fda-510k.jpg K961939 - S-ROM FEMORAL HIP STEM(SIZES 12 X 06 X 115 AND 12 X 07 X 115) K961939 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Aug 1996. https://www.510kdatabase.net/k962082/ 1996-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k962082-osteonics-all-polyethylene-glenoid-fda-510k.jpg K962082 - OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT K962082 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Aug 1996. https://www.510kdatabase.net/k960445/ 1996-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k960445-input-tuohy-borst-locking-device-fda-510k.jpg K960445 - INPUT TUOHY-BORST LOCKING DEVICE K960445 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Aug 1996. https://www.510kdatabase.net/k962785/ 1996-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k962785-3m-dent-system-fda-510k.jpg K962785 - 3M DENT SYSTEM K962785 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Aug 1996. https://www.510kdatabase.net/k961791/ 1996-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k961791-depuy-disposable-filterhood-fda-510k.jpg K961791 - DEPUY DISPOSABLE FILTER/HOOD K961791 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Depuy, Inc.. Cleared Aug 1996. https://www.510kdatabase.net/k962380/ 1996-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k962380-olympus-bf-type-200-video-fda-510k.jpg K962380 - OLYMPUS BF TYPE 200 VIDEO BRONCHSCOPES(BF-200/BF-P200/BF-IT200) K962380 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Olympus America, Inc.. Cleared Aug 1996. https://www.510kdatabase.net/k962530/ 1996-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k962530-prolene-polypropylene-mesh-fda-510k.jpg K962530 - PROLENE POLYPROPYLENE MESH NONABSORBABLE SYNTHETIC SURGICAL MESH K962530 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Aug 1996. https://www.510kdatabase.net/k962533/ 1996-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k962533-olypus-fg-series-grasping-forceps-fda-510k.jpg K962533 - OLYPUS FG SERIES GRASPING FORCEPS K962533 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Olympus America, Inc.. Cleared Aug 1996. https://www.510kdatabase.net/k954028/ 1996-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k954028-hp-sonos-ultrasound-imaging-system-fda-510k.jpg K954028 - HP SONOS ULTRASOUND IMAGING SYSTEM K954028 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Aug 1996. https://www.510kdatabase.net/k961902/ 1996-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k961902-siemens-beam-shaper-fda-510k.jpg K961902 - SIEMENS BEAM SHAPER K961902 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 1996. https://www.510kdatabase.net/k962002/ 1996-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k962002-aura-hip-system-calcar-replacement-fda-510k.jpg K962002 - AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM K962002 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Aug 1996. https://www.510kdatabase.net/k962132/ 1996-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k962132-silkon-stainless-steel-cable-system-fda-510k.jpg K962132 - SILKON STAINLESS STEEL CABLE SYSTEM K962132 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Aug 1996. https://www.510kdatabase.net/k962362/ 1996-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k962362-cordis-envoy-vista-brite-tip-guiding-fda-510k.jpg K962362 - CORDIS ENVOY & VISTA BRITE TIP GUIDING CATHETERS K962362 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Aug 1996. https://www.510kdatabase.net/k960976/ 1996-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k960976-kinematic-ii-replacement-tibial-inserts-fda-510k.jpg K960976 - KINEMATIC II REPLACEMENT TIBIAL INSERTS K960976 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Aug 1996. https://www.510kdatabase.net/k961413/ 1996-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k961413-synthes-anatomical-locking-plate-system-fda-510k.jpg K961413 - SYNTHES ANATOMICAL LOCKING PLATE SYSTEM K961413 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Aug 1996. https://www.510kdatabase.net/k960297/ 1996-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k960297-mandibular-bone-distractor-ii-fda-510k.jpg K960297 - MANDIBULAR BONE DISTRACTOR II K960297 is a FDA 510(k) cleared dental medical device. Manufacturer: Howmedica Corp.. Cleared Aug 1996. https://www.510kdatabase.net/k961825/ 1996-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k961825-ultraset3l-capd-disposable-disconnect-fda-510k.jpg K961825 - ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493 K961825 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Aug 1996. https://www.510kdatabase.net/k960574/ 1996-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k960574-argyle-turkel-neonatalpediatric-fda-510k.jpg K960574 - ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEM K960574 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Sherwood Medical Co.. Cleared Aug 1996. https://www.510kdatabase.net/k961571/ 1996-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k961571-cocr-bi-angular-humeral-component-fda-510k.jpg K961571 - COCR BI-ANGULAR HUMERAL COMPONENT K961571 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Aug 1996. https://www.510kdatabase.net/k962011/ 1996-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k962011-synthes-7073-mm-cannulated-screws-fda-510k.jpg K962011 - SYNTHES 7.0/7.3 MM CANNULATED SCREWS K962011 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Aug 1996. https://www.510kdatabase.net/k962022/ 1996-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k962022-powercut-gold-surgical-system-fda-510k.jpg K962022 - POWERCUT GOLD SURGICAL SYSTEM K962022 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Baxter Healthcare Corp. Cleared Aug 1996. https://www.510kdatabase.net/k962367/ 1996-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k962367-olympus-basket-graspers-fda-510k.jpg K962367 - OLYMPUS BASKET GRASPERS K962367 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Olympus America, Inc.. Cleared Aug 1996. https://www.510kdatabase.net/k962378/ 1996-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k962378-olympus-fg-4546-1-grasping-forceps-fda-510k.jpg K962378 - OLYMPUS FG-45/46-1 GRASPING FORCEPS K962378 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Olympus America, Inc.. Cleared Aug 1996. https://www.510kdatabase.net/k962480/ 1996-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k962480-coated-vicryl-rapide-polyglactin-910-fda-510k.jpg K962480 - COATED VICRYL RAPIDE (POLYGLACTIN 910) BRAIDED, SYNTHETIC ABSORBABLE SUTURE, UNDYED K962480 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Aug 1996. https://www.510kdatabase.net/k960257/ 1996-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k960257-n-antiserum-to-c1-inhibitor-fda-510k.jpg K960257 - N ANTISERUM TO C1 INHIBITOR K960257 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Aug 1996. https://www.510kdatabase.net/k961789/ 1996-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k961789-resorbable-soft-tissue-attachment-device-fda-510k.jpg K961789 - RESORBABLE SOFT TISSUE ATTACHMENT DEVICE K961789 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Aug 1996. https://www.510kdatabase.net/k961794/ 1996-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k961794-fluid-administration-set-contrast-fda-510k.jpg K961794 - FLUID ADMINISTRATION SET - CONTRAST MANAGER K961794 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Aug 1996. https://www.510kdatabase.net/k962007/ 1996-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k962007-protrusion-cages-fda-510k.jpg K962007 - PROTRUSION CAGES K962007 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Aug 1996. https://www.510kdatabase.net/k961014/ 1996-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k961014-quinton-model-q710-exercise-and-fda-510k.jpg K961014 - QUINTON MODEL Q710 EXERCISE AND RESTING ELECTROCARDIOGRAPH K961014 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Jul 1996. https://www.510kdatabase.net/k961438/ 1996-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k961438-ballon-dilatation-catheter-fda-510k.jpg K961438 - BALLON DILATATION CATHETER K961438 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Jul 1996. https://www.510kdatabase.net/k961802/ 1996-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k961802-preclude-synbloc-membrane-fda-510k.jpg K961802 - PRECLUDE SYNBLOC MEMBRANE K961802 is a FDA 510(k) cleared neurology medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Jul 1996. https://www.510kdatabase.net/k961871/ 1996-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k961871-flourospot-top-fda-510k.jpg K961871 - FLOUROSPOT T.O.P. K961871 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 1996. https://www.510kdatabase.net/k962387/ 1996-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k962387-olympus-fg-4546-1-grasping-fda-510k.jpg K962387 - OLYMPUS FG-45/46-1 GRASPING FORCEPS(UROLOGY) K962387 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus America, Inc.. Cleared Jul 1996. https://www.510kdatabase.net/k961679/ 1996-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k961679-transvenous-permanent-tined-target-tip-fda-510k.jpg K961679 - TRANSVENOUS, PERMANENT TINED TARGET TIP PACING LEADS/TRANSVENOUS, PERMANENT SCREW-IN PACING LEADS K961679 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jul 1996. https://www.510kdatabase.net/k962077/ 1996-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k962077-bard-biopty-cut-biopsy-needlewith-spacer-fda-510k.jpg K962077 - BARD BIOPTY-CUT BIOPSY NEEDLE/WITH SPACER K962077 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jul 1996. https://www.510kdatabase.net/k962555/ 1996-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k962555-olympus-fb-series-biopsy-forceps-fda-510k.jpg K962555 - OLYMPUS FB SERIES BIOPSY FORCEPS K962555 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Olympus America, Inc.. Cleared Jul 1996. https://www.510kdatabase.net/k951264/ 1996-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k951264-bipap-model-st-d-fda-510k.jpg K951264 - BIPAP MODEL S/T-D K951264 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Jul 1996. https://www.510kdatabase.net/k962407/ 1996-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k962407-nt-protein-control-py-fda-510k.jpg K962407 - N/T PROTEIN CONTROL PY K962407 is a FDA 510(k) cleared hematology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Jul 1996. https://www.510kdatabase.net/k960800/ 1996-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k960800-cedia-red-blood-cell-folate-no-boil-fda-510k.jpg K960800 - CEDIA RED BLOOD CELL FOLATE (NO BOIL REAGENT PACK) K960800 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jul 1996. https://www.510kdatabase.net/k960278/ 1996-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k960278-cobalt-chromium-molybdenum-co-cr-mo-fda-510k.jpg K960278 - COBALT-CHROMIUM-MOLYBDENUM (CO-CR-MO) ALLOY FEMORAL HEADS W/CO-NIDIUM SURFACE TREATMENT K960278 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jul 1996. https://www.510kdatabase.net/k961453/ 1996-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k961453-kodak-mn-r-2000-cassette-fda-510k.jpg K961453 - KODAK MN-R 2000 CASSETTE K961453 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Jul 1996. https://www.510kdatabase.net/k961900/ 1996-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k961900-tibial-tray-plug-a-product-line-fda-510k.jpg K961900 - TIBIAL TRAY PLUG, A PRODUCT LINE ADDITION TO THE AXIOM TOTAL KNEE SYSTEM K961900 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jul 1996. https://www.510kdatabase.net/k951851/ 1996-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k951851-alliance-cytomegalovirus-immediate-fda-510k.jpg K951851 - ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAY K951851 is a FDA 510(k) cleared microbiology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Jul 1996. https://www.510kdatabase.net/k960176/ 1996-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k960176-davol-nasogastric-sump-tube-wprevent-fda-510k.jpg K960176 - DAVOL NASOGASTRIC SUMP TUBE W/PREVENT FILTER K960176 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jul 1996. https://www.510kdatabase.net/k962016/ 1996-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k962016-medline-titanium-hemoclips-fda-510k.jpg K962016 - MEDLINE TITANIUM HEMOCLIPS K962016 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medline Industries, Inc.. Cleared Jul 1996. https://www.510kdatabase.net/k962047/ 1996-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k962047-titanium-cannulated-tibial-nail-ti-ctn-fda-510k.jpg K962047 - TITANIUM CANNULATED TIBIAL NAIL (TI CTN) K962047 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jul 1996. https://www.510kdatabase.net/k961577/ 1996-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k961577-prism-3000xpv-system-210714-fda-510k.jpg K961577 - PRISM 3000XPV SYSTEM (210714) K961577 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Jul 1996. https://www.510kdatabase.net/k961824/ 1996-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k961824-cobas-integra-reagent-cassettes-for-fda-510k.jpg K961824 - COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN K961824 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jul 1996. https://www.510kdatabase.net/k961491/ 1996-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k961491-elecsys-tsh-assay-fda-510k.jpg K961491 - ELECSYS TSH ASSAY K961491 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jul 1996. https://www.510kdatabase.net/k962573/ 1996-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k962573-elecsys-precicontrol-tsh-fda-510k.jpg K962573 - ELECSYS PRECICONTROL TSH K962573 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jul 1996. https://www.510kdatabase.net/k962575/ 1996-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k962575-elecsys-precicontrol-cardiac-fda-510k.jpg K962575 - ELECSYS PRECICONTROL CARDIAC K962575 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jul 1996. https://www.510kdatabase.net/k962694/ 1996-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k962694-opus-b12-controls-fda-510k.jpg K962694 - OPUS B12 CONTROLS K962694 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Jul 1996. https://www.510kdatabase.net/k961611/ 1996-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k961611-olympus-basket-graspers-urology-fda-510k.jpg K961611 - OLYMPUS BASKET GRASPERS (UROLOGY) K961611 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus America, Inc.. Cleared Jul 1996. https://www.510kdatabase.net/k961626/ 1996-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k961626-solo-cpap-system-fda-510k.jpg K961626 - SOLO CPAP SYSTEM K961626 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Jul 1996. https://www.510kdatabase.net/k961856/ 1996-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k961856-auto-suture-chemosite-tunneler-fda-510k.jpg K961856 - AUTO SUTURE CHEMOSITE TUNNELER K961856 is a FDA 510(k) cleared general hospital medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Jul 1996. https://www.510kdatabase.net/k962065/ 1996-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k962065-3m-vitrebond-light-cure-glass-fda-510k.jpg K962065 - 3M VITREBOND LIGHT CURE GLASS IONOMER/BASE K962065 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Jul 1996. https://www.510kdatabase.net/k962348/ 1996-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k962348-prime-bond-21-multipurpose-fda-510k.jpg K962348 - PRIME & BOND 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT K962348 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jul 1996. https://www.510kdatabase.net/k954982/ 1996-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k954982-ksea-scalp-blood-collection-set-fda-510k.jpg K954982 - KSEA SCALP BLOOD COLLECTION SET K954982 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jul 1996. https://www.510kdatabase.net/k951541/ 1996-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k951541-imx-rubella-igg-fda-510k.jpg K951541 - IMX RUBELLA IGG K951541 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Jul 1996. https://www.510kdatabase.net/k960658/ 1996-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k960658-collarless-polished-taper-hip-prosthesis-fda-510k.jpg K960658 - COLLARLESS POLISHED TAPER HIP PROSTHESIS K960658 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jul 1996. https://www.510kdatabase.net/k961997/ 1996-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k961997-ussc-braided-synthetic-absorbable-suture-fda-510k.jpg K961997 - USSC BRAIDED SYNTHETIC ABSORBABLE SUTURE K961997 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Jul 1996. https://www.510kdatabase.net/k962406/ 1996-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k962406-n-crp-standard-sy-fda-510k.jpg K962406 - N CRP STANDARD SY K962406 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Jul 1996. https://www.510kdatabase.net/k962410/ 1996-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k962410-n-protein-standard-py-fda-510k.jpg K962410 - N PROTEIN STANDARD PY K962410 is a FDA 510(k) cleared hematology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Jul 1996. https://www.510kdatabase.net/k961846/ 1996-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k961846-needle-catheter-fda-510k.jpg K961846 - NEEDLE CATHETER K961846 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Jul 1996. https://www.510kdatabase.net/k954559/ 1996-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k954559-howmedicca-modular-proximal-humerus-fda-510k.jpg K954559 - HOWMEDICCA MODULAR PROXIMAL HUMERUS REPLACEMENT SYSTEM K954559 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jul 1996. https://www.510kdatabase.net/k961619/ 1996-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k961619-depuy-endurance-calcar-hip-prosthesis-fda-510k.jpg K961619 - DEPUY ENDURANCE CALCAR HIP PROSTHESIS K961619 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jul 1996. https://www.510kdatabase.net/k961726/ 1996-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k961726-abuscreen-online-cannabinoids-fda-510k.jpg K961726 - ABUSCREEN ONLINE CANNABINOIDS CALIBRATION PACK 20 K961726 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jul 1996. https://www.510kdatabase.net/k962373/ 1996-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k962373-nt-rheumatology-control-sl1-and-sl2-fda-510k.jpg K962373 - N/T RHEUMATOLOGY CONTROL SL/1 AND SL/2 K962373 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Jul 1996. https://www.510kdatabase.net/k961340/ 1996-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k961340-nova-lite-anca-fda-510k.jpg K961340 - NOVA LITE ANCA K961340 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Jul 1996. https://www.510kdatabase.net/k961578/ 1996-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k961578-suture-anchor-fda-510k.jpg K961578 - SUTURE ANCHOR K961578 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Jul 1996. https://www.510kdatabase.net/k961585/ 1996-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k961585-surgical-dynamics-pop-rivet-fda-510k.jpg K961585 - SURGICAL DYNAMICS POP RIVET K961585 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Jul 1996. https://www.510kdatabase.net/k961685/ 1996-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k961685-pfc-cruciate-retaining-knee-system-fda-510k.jpg K961685 - P.F.C. CRUCIATE RETAINING KNEE SYSTEM (SIZE 1.5) K961685 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jul 1996. https://www.510kdatabase.net/k961913/ 1996-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k961913-quanta-lite-ena-6-elisa-fda-510k.jpg K961913 - QUANTA LITE ENA 6 ELISA K961913 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Jul 1996. https://www.510kdatabase.net/k962523/ 1996-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k962523-n-latex-crp-mono-reagent-fda-510k.jpg K962523 - N LATEX CRP MONO REAGENT K962523 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Jul 1996. https://www.510kdatabase.net/k961445/ 1996-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k961445-radifocus-glidewire-for-coronary-use-fda-510k.jpg K961445 - RADIFOCUS GLIDEWIRE FOR CORONARY USE WITH PLATINUM (OR GOLD) COIL K961445 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Jul 1996. https://www.510kdatabase.net/k961483/ 1996-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k961483-duracon-all-polyethylene-patella-ii-fda-510k.jpg K961483 - DURACON ALL POLYETHYLENE PATELLA II K961483 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jul 1996. https://www.510kdatabase.net/k955743/ 1996-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k955743-siemens-sc-6000sc-6000-p-portable-fda-510k.jpg K955743 - SIEMENS SC 6000/SC 6000 P PORTABLE BEDSIDE MONITORING SYSTEM K955743 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 1996. https://www.510kdatabase.net/k960392/ 1996-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k960392-cdm-fda-510k.jpg K960392 - CDM K960392 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Jul 1996. https://www.510kdatabase.net/k961703/ 1996-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k961703-colleague-2-volumetric-infusion-fda-510k.jpg K961703 - COLLEAGUE 2 VOLUMETRIC INFUSION PUMP(DUAL CHANNEL)/COLLEAGUE 3 VOLUMETRIC INFUSION PUMP(TREE CHANNEL) K961703 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jul 1996. https://www.510kdatabase.net/k960497/ 1996-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k960497-flexible-phased-array-spine-coil-fda-510k.jpg K960497 - FLEXIBLE PHASED ARRAY SPINE COIL K960497 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Jul 1996. https://www.510kdatabase.net/k961274/ 1996-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k961274-olympus-au600-clinical-chemistry-fda-510k.jpg K961274 - OLYMPUS AU600 CLINICAL CHEMISTRY ANALYZER K961274 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus America, Inc.. Cleared Jul 1996. https://www.510kdatabase.net/k961482/ 1996-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k961482-duracon-inset-patella-with-central-peg-fda-510k.jpg K961482 - DURACON INSET PATELLA WITH CENTRAL PEG K961482 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jul 1996. https://www.510kdatabase.net/k962032/ 1996-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k962032-karl-storz-twin-transilluminator-fda-510k.jpg K962032 - KARL STORZ TWIN TRANSILLUMINATOR K962032 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jul 1996. https://www.510kdatabase.net/k960265/ 1996-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k960265-advantage-windows-with-functool-option-fda-510k.jpg K960265 - ADVANTAGE WINDOWS WITH FUNCTOOL OPTION K960265 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Jul 1996. https://www.510kdatabase.net/k961637/ 1996-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k961637-picker-mr-workstations-vistarmontage-fda-510k.jpg K961637 - PICKER MR WORKSTATIONS (VISTAR,MONTAGE AND ONCALL) K961637 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Jul 1996. https://www.510kdatabase.net/k960947/ 1996-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k960947-sas-sickle-cell-test-fda-510k.jpg K960947 - SAS SICKLE CELL TEST K960947 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Jul 1996. https://www.510kdatabase.net/k953805/ 1996-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k953805-09-sodium-chloride-diluent-in-plastic-fda-510k.jpg K953805 - 0.9% SODIUM CHLORIDE DILUENT IN PLASTIC SYRINGE K953805 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1996. https://www.510kdatabase.net/k961350/ 1996-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k961350-synthes-mini-external-fixator-fda-510k.jpg K961350 - SYNTHES MINI EXTERNAL FIXATOR K961350 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jun 1996. https://www.510kdatabase.net/k961271/ 1996-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k961271-usci-commander-series-guide-wires-fda-510k.jpg K961271 - USCI COMMANDER SERIES GUIDE WIRES K961271 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jun 1996. https://www.510kdatabase.net/k961462/ 1996-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k961462-cedia-theophylline-assay-fda-510k.jpg K961462 - CEDIA THEOPHYLLINE ASSAY K961462 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jun 1996. https://www.510kdatabase.net/k953741/ 1996-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k953741-thermacyl-bloodfluid-warmer-fda-510k.jpg K953741 - THERMACYL BLOOD/FLUID WARMER K953741 is a FDA 510(k) cleared hematology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jun 1996. https://www.510kdatabase.net/k954572/ 1996-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k954572-maestro-clinical-remote-control-fda-510k.jpg K954572 - MAESTRO CLINICAL REMOTE CONTROL K954572 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Jun 1996. https://www.510kdatabase.net/k961421/ 1996-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k961421-synthes-24-mm-universal-locking-plate-fda-510k.jpg K961421 - SYNTHES 2.4 MM UNIVERSAL LOCKING PLATE SYSTEM K961421 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Jun 1996. https://www.510kdatabase.net/k961495/ 1996-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k961495-huber-needle-extension-set-with-fda-510k.jpg K961495 - HUBER NEEDLE EXTENSION SET WITH STANDARD Y-INJECTION SITE, INTERLINK Y-INJECTION SITE, INTERLINK T-INJECTION SITE K961495 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jun 1996. https://www.510kdatabase.net/k961995/ 1996-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k961995-quicksplint-fda-510k.jpg K961995 - QUICKSPLINT K961995 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Jun 1996. https://www.510kdatabase.net/k962165/ 1996-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k962165-cobas-fp-tdm-calibration-verification-fda-510k.jpg K962165 - COBAS-FP TDM CALIBRATION VERIFICATION TEST SET K962165 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jun 1996. https://www.510kdatabase.net/k962035/ 1996-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k962035-ge-sterile-arthrogram-tray-fda-510k.jpg K962035 - GE STERILE ARTHROGRAM TRAY K962035 is a FDA 510(k) cleared general hospital medical device. Manufacturer: GE Medical Systems. Cleared Jun 1996. https://www.510kdatabase.net/k961569/ 1996-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k961569-dall-miles-stainless-steel-beaded-cable-fda-510k.jpg K961569 - DALL-MILES STAINLESS STEEL BEADED CABLE K961569 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jun 1996. https://www.510kdatabase.net/k950670/ 1996-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k950670-immulite-herpes-i-and-ii-igg-fda-510k.jpg K950670 - IMMULITE HERPES I AND II IGG K950670 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jun 1996. https://www.510kdatabase.net/k960303/ 1996-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k960303-fenning-femoral-component-fda-510k.jpg K960303 - FENNING FEMORAL COMPONENT K960303 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jun 1996. https://www.510kdatabase.net/k960978/ 1996-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k960978-wright-plaster-of-paris-pellets-fda-510k.jpg K960978 - WRIGHT PLASTER OF PARIS PELLETS (SUBJECT TO REVISION) K960978 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jun 1996. https://www.510kdatabase.net/k961219/ 1996-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k961219-percutaneous-introducer-system-fda-510k.jpg K961219 - PERCUTANEOUS INTRODUCER SYSTEM K961219 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Boston Scientific Corp. Cleared Jun 1996. https://www.510kdatabase.net/k961225/ 1996-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k961225-continuflo-solution-setsecondary-fda-510k.jpg K961225 - CONTINUFLO SOLUTION SET/SECONDARY MEDICATION SET K961225 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jun 1996. https://www.510kdatabase.net/k961436/ 1996-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k961436-abuscreen-online-lsd-reagent-90-ml-fda-510k.jpg K961436 - ABUSCREEN ONLINE LSD REAGENT (90 ML TEST KIT) K961436 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jun 1996. https://www.510kdatabase.net/k955550/ 1996-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k955550-cardifix-ez-bipolarunipolar-fda-510k.jpg K955550 - CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEAD K955550 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Jun 1996. https://www.510kdatabase.net/k961121/ 1996-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k961121-kinematic-knee-devicemagnetom-open-fda-510k.jpg K961121 - KINEMATIC KNEE DEVICE/MAGNETOM OPEN SYSTEM K961121 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 1996. https://www.510kdatabase.net/k961134/ 1996-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k961134-bard-graft-sizer-fda-510k.jpg K961134 - BARD GRAFT SIZER K961134 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jun 1996. https://www.510kdatabase.net/k961210/ 1996-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k961210-sam-facial-implant-fda-510k.jpg K961210 - SAM FACIAL IMPLANT K961210 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Jun 1996. https://www.510kdatabase.net/k961234/ 1996-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k961234-depuy-advantage-fixation-screw-system-fda-510k.jpg K961234 - DEPUY ADVANTAGE FIXATION SCREW SYSTEM K961234 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jun 1996. https://www.510kdatabase.net/k955457/ 1996-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k955457-digiscan-2-plus-fda-510k.jpg K955457 - DIGISCAN 2 PLUS K955457 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 1996. https://www.510kdatabase.net/k960281/ 1996-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k960281-implantable-pacing-leadsimplantable-fda-510k.jpg K960281 - IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORY K960281 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Jun 1996. https://www.510kdatabase.net/k961379/ 1996-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k961379-depuy-amk-porous-coated-crx-tibial-fda-510k.jpg K961379 - DEPUY AMK POROUS COATED CRX TIBIAL TRAY (1988-20/28-000 AND 1988-20/28-501) K961379 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jun 1996. https://www.510kdatabase.net/k961948/ 1996-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k961948-sas-salmonella-o-factor-20-antiserum-fda-510k.jpg K961948 - SAS SALMONELLA O FACTOR 20 ANTISERUM K961948 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Jun 1996. https://www.510kdatabase.net/k961949/ 1996-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k961949-sas-salmonella-o-factor-14-antiserum-fda-510k.jpg K961949 - SAS SALMONELLA O FACTOR 14 ANTISERUM K961949 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Jun 1996. https://www.510kdatabase.net/k961950/ 1996-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k961950-sas-salmonella-o-factor-15-antiserum-fda-510k.jpg K961950 - SAS SALMONELLA O FACTOR 15 ANTISERUM &/OR O GROUP E2 FACTOR 15 ANTISERUM K961950 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Jun 1996. https://www.510kdatabase.net/k961951/ 1996-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k961951-sas-salmonella-o-factor-6-antiserum-fda-510k.jpg K961951 - SAS SALMONELLA O FACTOR 6 ANTISERUM K961951 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Jun 1996. https://www.510kdatabase.net/k961952/ 1996-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k961952-sas-salmonella-o-factor-o-group-a-fda-510k.jpg K961952 - SAS SALMONELLA O FACTOR /O GROUP A FACTOR 2 ANTISERUMS K961952 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Jun 1996. https://www.510kdatabase.net/k961953/ 1996-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k961953-sas-salmonela-h-z24-antiserum-fda-510k.jpg K961953 - SAS SALMONELA H Z24 ANTISERUM K961953 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Jun 1996. https://www.510kdatabase.net/k961954/ 1996-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k961954-sas-salmonella-h-z35-antiserum-fda-510k.jpg K961954 - SAS SALMONELLA H Z35 ANTISERUM K961954 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Jun 1996. https://www.510kdatabase.net/k961955/ 1996-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k961955-sas-salmonella-h-z42-antiserum-fda-510k.jpg K961955 - SAS SALMONELLA H Z42 ANTISERUM K961955 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Jun 1996. https://www.510kdatabase.net/k961956/ 1996-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k961956-sas-salmonella-h-gmq-antisermu-fda-510k.jpg K961956 - SAS SALMONELLA H G,M,Q ANTISERMU K961956 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Jun 1996. https://www.510kdatabase.net/k961957/ 1996-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k961957-sas-salmonella-h-z4-z32-antiserum-fda-510k.jpg K961957 - SAS SALMONELLA H Z4, Z32 ANTISERUM K961957 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Jun 1996. https://www.510kdatabase.net/k961958/ 1996-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k961958-sas-salmonella-h-z4-complex-antiserum-fda-510k.jpg K961958 - SAS SALMONELLA H Z4 COMPLEX ANTISERUM K961958 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Jun 1996. https://www.510kdatabase.net/k961960/ 1996-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k961960-sas-salmonella-h-z4-z24-antiserum-fda-510k.jpg K961960 - SAS SALMONELLA H Z4, Z24 ANTISERUM K961960 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Jun 1996. https://www.510kdatabase.net/k961961/ 1996-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k961961-sas-salmonella-h-fgt-antiserum-fda-510k.jpg K961961 - SAS SALMONELLA H F,G,T ANTISERUM K961961 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Jun 1996. https://www.510kdatabase.net/k961962/ 1996-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k961962-sas-salmonella-o-group-v-factor-44-fda-510k.jpg K961962 - SAS SALMONELLA O GROUP V FACTOR 44 ANTISERUM K961962 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Jun 1996. https://www.510kdatabase.net/k961963/ 1996-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k961963-sas-salmonella-o-group-w-factor-45-fda-510k.jpg K961963 - SAS SALMONELLA O GROUP W FACTOR 45 ANTISERUM K961963 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Jun 1996. https://www.510kdatabase.net/k961964/ 1996-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k961964-sas-salmonella-o-group-h-factors-fda-510k.jpg K961964 - SAS SALMONELLA O GROUP H FACTORS 14,24,25 ANTISERUM K961964 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Jun 1996. https://www.510kdatabase.net/k961966/ 1996-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k961966-sas-salmonella-o-group-x-factor-47-fda-510k.jpg K961966 - SAS SALMONELLA O GROUP X FACTOR 47 ANTISERUM K961966 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Jun 1996. https://www.510kdatabase.net/k961967/ 1996-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k961967-sas-salmonella-o-poly-b-antiserum-fda-510k.jpg K961967 - SAS SALMONELLA O POLY B ANTISERUM K961967 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Jun 1996. https://www.510kdatabase.net/k950672/ 1996-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k950672-immulite-cmv-igg-fda-510k.jpg K950672 - IMMULITE CMV IGG K950672 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jun 1996. https://www.510kdatabase.net/k961009/ 1996-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k961009-stresswriter-exercise-testing-system-fda-510k.jpg K961009 - STRESSWRITER EXERCISE TESTING SYSTEM K961009 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Jun 1996. https://www.510kdatabase.net/k961055/ 1996-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k961055-ct-prospeed-cti-fda-510k.jpg K961055 - CT PROSPEED CT/I K961055 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Jun 1996. https://www.510kdatabase.net/k960934/ 1996-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k960934-hp-m1205a-omnicare-component-monitor-fda-510k.jpg K960934 - HP M1205A OMNICARE COMPONENT MONITOR SYSTEM MODEL 24 K960934 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Jun 1996. https://www.510kdatabase.net/k961092/ 1996-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k961092-visart-fda-510k.jpg K961092 - VISART K961092 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Jun 1996. https://www.510kdatabase.net/k961481/ 1996-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k961481-elecsys-2010-analyzer-fda-510k.jpg K961481 - ELECSYS 2010 ANALYZER K961481 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jun 1996. https://www.510kdatabase.net/k962030/ 1996-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k962030-karl-storz-remorgida-forceps-fda-510k.jpg K962030 - KARL STORZ REMORGIDA FORCEPS K962030 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jun 1996. https://www.510kdatabase.net/k961213/ 1996-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k961213-alta-dome-and-plunger-mec-hip-bolt-fda-510k.jpg K961213 - ALTA DOME AND PLUNGER (MEC HIP BOLT) K961213 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jun 1996. https://www.510kdatabase.net/k961490/ 1996-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k961490-elecsys-t4-assay-fda-510k.jpg K961490 - ELECSYS T4 ASSAY K961490 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jun 1996. https://www.510kdatabase.net/k961620/ 1996-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k961620-abiscreen-online-for-cannabinoids-es-fda-510k.jpg K961620 - ABISCREEN ONLINE FOR CANNABINOIDS - ES 50/100 K961620 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jun 1996. https://www.510kdatabase.net/k961659/ 1996-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k961659-cedia-core-tdm-multi-cal-fda-510k.jpg K961659 - CEDIA CORE TDM MULTI-CAL K961659 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jun 1996. https://www.510kdatabase.net/k961487/ 1996-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k961487-elecsys-hcg-assay-fda-510k.jpg K961487 - ELECSYS HCG ASSAY K961487 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jun 1996. https://www.510kdatabase.net/k961488/ 1996-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k961488-elecsys-t-uptake-assay-fda-510k.jpg K961488 - ELECSYS T-UPTAKE ASSAY K961488 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jun 1996. https://www.510kdatabase.net/k961489/ 1996-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k961489-elecsys-ft4-assay-fda-510k.jpg K961489 - ELECSYS FT4 ASSAY K961489 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jun 1996. https://www.510kdatabase.net/k961500/ 1996-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k961500-elecsys-troponin-t-fda-510k.jpg K961500 - ELECSYS TROPONIN T K961500 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jun 1996. https://www.510kdatabase.net/k961501/ 1996-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k961501-elecsys-ck-mb-fda-510k.jpg K961501 - ELECSYS CK-MB K961501 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jun 1996. https://www.510kdatabase.net/k961828/ 1996-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k961828-liquichek-cardiac-markers-control-cat-fda-510k.jpg K961828 - LIQUICHEK CARDIAC MARKERS CONTROL (CAT. NO. 685,686,687,688) K961828 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Jun 1996. https://www.510kdatabase.net/k955389/ 1996-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k955389-mr-guided-procedures-packagemagnetom-fda-510k.jpg K955389 - MR GUIDED PROCEDURES PACKAGE/MAGNETOM OPEN SYSTEM K955389 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 1996. https://www.510kdatabase.net/k952054/ 1996-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k952054-siemens-sirecust-monitoring-1200-1200-fda-510k.jpg K952054 - SIEMENS SIRECUST MONITORING (1200, 1200 NEO, 960) K952054 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 1996. https://www.510kdatabase.net/k955059/ 1996-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k955059-olympus-comm-ntwk-sc-3000-wkst-remote-fda-510k.jpg K955059 - OLYMPUS COMM. NTWK., SC 3000 WKST. & REMOTE DISPLAY, R 100 RECORDER K955059 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 1996. https://www.510kdatabase.net/k960704/ 1996-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k960704-depuy-m-kurosaka-advange-mangnum-rev-fda-510k.jpg K960704 - DEPUY M. KUROSAKA ADVANGE MANGNUM REV. INTERFERENCE SCREWS K960704 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jun 1996. https://www.510kdatabase.net/k961154/ 1996-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k961154-baxter-sodium-acetate-infant-heel-warmer-fda-510k.jpg K961154 - BAXTER SODIUM ACETATE INFANT HEEL WARMER K961154 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jun 1996. https://www.510kdatabase.net/k960987/ 1996-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k960987-liquichek-rheumatoid-factor-control-fda-510k.jpg K960987 - LIQUICHEK RHEUMATOID FACTOR CONTROL K960987 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Jun 1996. https://www.510kdatabase.net/k961485/ 1996-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k961485-forefoot-reconstruction-system-fda-510k.jpg K961485 - FOREFOOT RECONSTRUCTION SYSTEM K961485 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jun 1996. https://www.510kdatabase.net/k961147/ 1996-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k961147-closed-fluid-collection-system-fda-510k.jpg K961147 - CLOSED FLUID COLLECTION SYSTEM K961147 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: B.Braun Medical, Inc.. Cleared May 1996. https://www.510kdatabase.net/k961537/ 1996-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k961537-sas-shigella-sonnei-form-ii-antiserum-fda-510k.jpg K961537 - SAS SHIGELLA SONNEI FORM II ANTISERUM K961537 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared May 1996. https://www.510kdatabase.net/k961713/ 1996-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k961713-instrument-set-for-arthroscopic-fda-510k.jpg K961713 - INSTRUMENT SET FOR ARTHROSCOPIC PERCUTANEOUS DISCECTOMY K961713 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared May 1996. https://www.510kdatabase.net/k936054/ 1996-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k936054-imx-select-chlamydia-fda-510k.jpg K936054 - IMX SELECT CHLAMYDIA K936054 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared May 1996. https://www.510kdatabase.net/k952791/ 1996-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k952791-directigen-meningitis-combo-test-fda-510k.jpg K952791 - DIRECTIGEN MENINGITIS COMBO TEST K952791 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared May 1996. https://www.510kdatabase.net/k955278/ 1996-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k955278-behring-coagulation-timer-fda-510k.jpg K955278 - BEHRING COAGULATION TIMER K955278 is a FDA 510(k) cleared hematology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared May 1996. https://www.510kdatabase.net/k954283/ 1996-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k954283-energized-container-system-modification-fda-510k.jpg K954283 - ENERGIZED CONTAINER SYSTEM (MODIFICATION) K954283 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared May 1996. https://www.510kdatabase.net/k960466/ 1996-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k960466-ivex-2-extension-set-with-y-injection-fda-510k.jpg K960466 - IVEX-2 EXTENSION SET WITH Y-INJECTION SITE (MODIFICATION) K960466 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared May 1996. https://www.510kdatabase.net/k960973/ 1996-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k960973-movable-add-on-couch-for-outlook-fda-510k.jpg K960973 - MOVABLE ADD-ON COUCH FOR OUTLOOK K960973 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared May 1996. https://www.510kdatabase.net/k960834/ 1996-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k960834-kodak-ec-l-cassette-fda-510k.jpg K960834 - KODAK EC-L CASSETTE K960834 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared May 1996. https://www.510kdatabase.net/k961248/ 1996-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k961248-bard-plat-class-3-french-ureteroscopic-fda-510k.jpg K961248 - BARD PLAT. CLASS 3 FRENCH URETEROSCOPIC FLAT WIRE STONE, TORQUE HELICAL STONE BASKETS/GRASPING FORCEPS K961248 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 1996. https://www.510kdatabase.net/k961291/ 1996-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k961291-finesse-low-fusing-porcelain-system-fda-510k.jpg K961291 - FINESSE LOW-FUSING PORCELAIN SYSTEM AUXILIARY PRODUCTS K961291 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared May 1996. https://www.510kdatabase.net/k961618/ 1996-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k961618-monotube-tube-to-ring-clamp-fda-510k.jpg K961618 - MONOTUBE TUBE TO RING CLAMP K961618 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared May 1996. https://www.510kdatabase.net/k960532/ 1996-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k960532-preclude-ima-sleeve-fda-510k.jpg K960532 - PRECLUDE IMA SLEEVE K960532 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared May 1996. https://www.510kdatabase.net/k960446/ 1996-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k960446-model-5471-5471l-sterile-disposable-fda-510k.jpg K960446 - MODEL 5471 & 5471L STERILE DISPOSABLE PATIENT CABLE ASSEMBLIES K960446 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared May 1996. https://www.510kdatabase.net/k960955/ 1996-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k960955-jackson-pratt-gold-wound-drains-with-fda-510k.jpg K960955 - JACKSON-PRATT GOLD WOUND DRAINS WITH DURAFLO II COATING K960955 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Baxter Healthcare Corp. Cleared May 1996. https://www.510kdatabase.net/k961283/ 1996-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k961283-dall-miles-homogenous-vitallium-cable-fda-510k.jpg K961283 - DALL-MILES HOMOGENOUS VITALLIUM CABLE K961283 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared May 1996. https://www.510kdatabase.net/k953940/ 1996-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k953940-terumo-retractable-needle-rn-syringe-fda-510k.jpg K953940 - TERUMO RETRACTABLE NEEDLE (RN) SYRINGE K953940 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terumo Medical Corp.. Cleared May 1996. https://www.510kdatabase.net/k960631/ 1996-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k960631-medtronic-model-3550-accessory-kit-fda-510k.jpg K960631 - MEDTRONIC MODEL 3550 ACCESSORY KIT (CONTENTS) 3550-OX K960631 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared May 1996. https://www.510kdatabase.net/k954953/ 1996-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k954953-b-d-durasafe-combined-spinal-epidural-fda-510k.jpg K954953 - B-D DURASAFE COMBINED SPINAL EPIDURAL (CSE) TRAY K954953 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared May 1996. https://www.510kdatabase.net/k955646/ 1996-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k955646-vicryl-peridontal-mesh-fda-510k.jpg K955646 - VICRYL PERIDONTAL MESH K955646 is a FDA 510(k) cleared dental medical device. Manufacturer: Ethicon, Inc.. Cleared May 1996. https://www.510kdatabase.net/k955673/ 1996-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k955673-cell-dyn-3000-multi-parameter-fda-510k.jpg K955673 - CELL DYN 3000 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (MODIFICATION) K955673 is a FDA 510(k) cleared hematology medical device. Manufacturer: Abbott Laboratories. Cleared May 1996. https://www.510kdatabase.net/k960920/ 1996-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k960920-clinix-mp-fda-510k.jpg K960920 - CLINIX MP K960920 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared May 1996. https://www.510kdatabase.net/k961352/ 1996-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k961352-285-sl-fda-510k.jpg K961352 - 285 SL K961352 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared May 1996. https://www.510kdatabase.net/k961528/ 1996-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k961528-sas-shigella-boydii-type-11-antiserum-fda-510k.jpg K961528 - SAS SHIGELLA BOYDII TYPE 11 ANTISERUM (3/100/1000ML) K961528 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared May 1996. https://www.510kdatabase.net/k961529/ 1996-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k961529-sas-shigella-boydii-type-12-antiserum-fda-510k.jpg K961529 - SAS SHIGELLA BOYDII TYPE 12 ANTISERUM K961529 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared May 1996. https://www.510kdatabase.net/k961531/ 1996-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k961531-sas-shigella-boydii-type-13-antiserum-fda-510k.jpg K961531 - SAS SHIGELLA BOYDII TYPE 13 ANTISERUM K961531 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared May 1996. https://www.510kdatabase.net/k961532/ 1996-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k961532-sas-shigella-flexneri-type-5-antiserum-fda-510k.jpg K961532 - SAS SHIGELLA FLEXNERI TYPE 5 ANTISERUM K961532 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared May 1996. https://www.510kdatabase.net/k961533/ 1996-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k961533-sas-shigella-flexneri-type-6-antiserum-fda-510k.jpg K961533 - SAS SHIGELLA FLEXNERI TYPE 6 ANTISERUM K961533 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared May 1996. https://www.510kdatabase.net/k961534/ 1996-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k961534-sas-shigella-sonnei-form-i-antiserum-fda-510k.jpg K961534 - SAS SHIGELLA SONNEI FORM I ANTISERUM (3/100/1000ML) K961534 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared May 1996. https://www.510kdatabase.net/k961535/ 1996-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k961535-sas-shigella-dysenteriae-group-a1-8-10-fda-510k.jpg K961535 - SAS SHIGELLA DYSENTERIAE GROUP A1 (8-10) ANTISERUM K961535 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared May 1996. https://www.510kdatabase.net/k961538/ 1996-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k961538-sas-shigella-dysenteriae-type-8-fda-510k.jpg K961538 - SAS SHIGELLA DYSENTERIAE TYPE 8 ANTISERUM K961538 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared May 1996. https://www.510kdatabase.net/k961539/ 1996-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k961539-sas-shigella-dysenteriae-type-10-fda-510k.jpg K961539 - SAS SHIGELLA DYSENTERIAE TYPE 10 ANTISERUM K961539 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared May 1996. https://www.510kdatabase.net/k961540/ 1996-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k961540-sas-shigella-sonnei-group-d-antiserum-fda-510k.jpg K961540 - SAS SHIGELLA SONNEI GROUP D ANTISERUM K961540 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared May 1996. https://www.510kdatabase.net/k961541/ 1996-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k961541-sas-shigella-boydii-type-8-antiserum-fda-510k.jpg K961541 - SAS SHIGELLA BOYDII TYPE 8 ANTISERUM K961541 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared May 1996. https://www.510kdatabase.net/k961542/ 1996-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k961542-sas-shigella-flexneri-type-4-antiserum-fda-510k.jpg K961542 - SAS SHIGELLA FLEXNERI TYPE 4 ANTISERUM K961542 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared May 1996. https://www.510kdatabase.net/k961543/ 1996-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k961543-sas-shigella-boydii-type-9-antiserum-fda-510k.jpg K961543 - SAS SHIGELLA BOYDII TYPE 9 ANTISERUM K961543 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared May 1996. https://www.510kdatabase.net/k961546/ 1996-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k961546-sas-shigella-boydii-group-c1c1-8-10-fda-510k.jpg K961546 - SAS SHIGELLA BOYDII GROUP C1/C1 (8-10) ANTISERUM K961546 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared May 1996. https://www.510kdatabase.net/k961547/ 1996-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k961547-sas-shigella-boydii-type-14-antiserum-fda-510k.jpg K961547 - SAS SHIGELLA BOYDII TYPE 14 ANTISERUM K961547 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared May 1996. https://www.510kdatabase.net/k961548/ 1996-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k961548-sas-shigella-boydii-type-15-antiserum-fda-510k.jpg K961548 - SAS SHIGELLA BOYDII TYPE 15 ANTISERUM K961548 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared May 1996. https://www.510kdatabase.net/k961549/ 1996-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k961549-sas-shigella-flexneri-type-2-antiserum-fda-510k.jpg K961549 - SAS SHIGELLA FLEXNERI TYPE 2 ANTISERUM K961549 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared May 1996. https://www.510kdatabase.net/k961551/ 1996-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k961551-sas-shigella-dysenteriae-type-2-fda-510k.jpg K961551 - SAS SHIGELLA DYSENTERIAE TYPE 2 ANTISERUM K961551 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared May 1996. https://www.510kdatabase.net/k961553/ 1996-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k961553-sas-shigella-dysenteriae-type-1-fda-510k.jpg K961553 - SAS SHIGELLA DYSENTERIAE TYPE 1 ANTISERUM K961553 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared May 1996. https://www.510kdatabase.net/k961554/ 1996-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k961554-sas-shigella-boydii-type-10-antiserum-fda-510k.jpg K961554 - SAS SHIGELLA BOYDII TYPE 10 ANTISERUM K961554 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared May 1996. https://www.510kdatabase.net/k961556/ 1996-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k961556-sas-shigella-flexneri-type-1-antiserum-fda-510k.jpg K961556 - SAS SHIGELLA FLEXNERI TYPE 1 ANTISERUM K961556 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared May 1996. https://www.510kdatabase.net/k961558/ 1996-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k961558-sas-shigella-flexneri-type-3-antiserum-fda-510k.jpg K961558 - SAS SHIGELLA FLEXNERI TYPE 3 ANTISERUM K961558 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared May 1996. https://www.510kdatabase.net/k961559/ 1996-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k961559-sas-shigella-dysenteriae-type-9-fda-510k.jpg K961559 - SAS SHIGELLA DYSENTERIAE TYPE 9 ANTISERUM K961559 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared May 1996. https://www.510kdatabase.net/k941593/ 1996-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k941593-diagnostic-ultrasonic-transducer-fda-510k.jpg K941593 - DIAGNOSTIC ULTRASONIC TRANSDUCER K941593 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared May 1996. https://www.510kdatabase.net/k955291/ 1996-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k955291-dualscreen-fda-510k.jpg K955291 - DUALSCREEN K955291 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared May 1996. https://www.510kdatabase.net/k950335/ 1996-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k950335-karl-storz-rigid-telescopes-for-fda-510k.jpg K950335 - KARL STORZ RIGID TELESCOPES FOR OBSTERICS AND GYNECOLOGY K950335 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared May 1996. https://www.510kdatabase.net/k961168/ 1996-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k961168-viewpoint-fda-510k.jpg K961168 - VIEWPOINT K961168 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared May 1996. https://www.510kdatabase.net/k954980/ 1996-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k954980-pagewriter-200-200i-cardiograph-fda-510k.jpg K954980 - PAGEWRITER 200, 200I CARDIOGRAPH & INTERPRETIVE CARDIO K954980 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared May 1996. https://www.510kdatabase.net/k955533/ 1996-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k955533-diastat-vascular-access-graft-fda-510k.jpg K955533 - DIASTAT VASCULAR ACCESS GRAFT K955533 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared May 1996. https://www.510kdatabase.net/k955585/ 1996-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k955585-v2-injection-site-fda-510k.jpg K955585 - V2 INJECTION SITE K955585 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared May 1996. https://www.510kdatabase.net/k961256/ 1996-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k961256-synchron-systems-valproic-acid-vpa-fda-510k.jpg K961256 - SYNCHRON SYSTEMS VALPROIC ACID (VPA) REAGENT K961256 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared May 1996. https://www.510kdatabase.net/k961349/ 1996-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k961349-injection-gold-probe-fda-510k.jpg K961349 - INJECTION GOLD PROBE K961349 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared May 1996. https://www.510kdatabase.net/k954318/ 1996-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k954318-abbott-axsym-rubella-igm-antibody-assay-fda-510k.jpg K954318 - ABBOTT AXSYM RUBELLA IGM ANTIBODY ASSAY K954318 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared May 1996. https://www.510kdatabase.net/k960787/ 1996-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k960787-turarthroscopiccystoscopy-irrigation-fda-510k.jpg K960787 - TUR,ARTHROSCOPIC,CYSTOSCOPY IRRIGATION SETS K960787 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared May 1996. https://www.510kdatabase.net/k961178/ 1996-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k961178-karl-storz-intubation-fiberscope-fda-510k.jpg K961178 - KARL STORZ INTUBATION FIBERSCOPE K961178 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared May 1996. https://www.510kdatabase.net/k960677/ 1996-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k960677-kangaroo-jejunal-feeding-system-fda-510k.jpg K960677 - KANGAROO JEJUNAL FEEDING SYSTEM K960677 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Sherwood Medical Co.. Cleared May 1996. https://www.510kdatabase.net/k960470/ 1996-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k960470-neuro-patch-fda-510k.jpg K960470 - NEURO-PATCH K960470 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared May 1996. https://www.510kdatabase.net/k960485/ 1996-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k960485-synchron-systems-iron-fetotal-iron-fda-510k.jpg K960485 - SYNCHRON SYSTEMS IRON (FE)/TOTAL IRON BINDING CAPACITY REAGENTS K960485 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared May 1996. https://www.510kdatabase.net/k955851/ 1996-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k955851-axsym-vancomycin-ii-fda-510k.jpg K955851 - AXSYM VANCOMYCIN II K955851 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared May 1996. https://www.510kdatabase.net/k960632/ 1996-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k960632-kangaroo-feeding-tube-placment-stylet-fda-510k.jpg K960632 - KANGAROO FEEDING TUBE PLACMENT STYLET K960632 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Sherwood Medical Co.. Cleared May 1996. https://www.510kdatabase.net/k955728/ 1996-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k955728-cordis-biliary-stent-fda-510k.jpg K955728 - CORDIS BILIARY STENT K955728 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared May 1996. https://www.510kdatabase.net/k960617/ 1996-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k960617-advance-tibial-component-fda-510k.jpg K960617 - ADVANCE TIBIAL COMPONENT K960617 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared May 1996. https://www.510kdatabase.net/k960782/ 1996-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k960782-titanium-tube-to-tube-clamp-fda-510k.jpg K960782 - TITANIUM TUBE TO TUBE CLAMP K960782 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared May 1996. https://www.510kdatabase.net/k954957/ 1996-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k954957-codemaster-xl-xl-wshock-advisory-option-fda-510k.jpg K954957 - CODEMASTER XL + XL W/SHOCK ADVISORY OPTION K954957 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared May 1996. https://www.510kdatabase.net/k960575/ 1996-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k960575-advantx-lcv-fda-510k.jpg K960575 - ADVANTX LCV+ K960575 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared May 1996. https://www.510kdatabase.net/k961244/ 1996-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k961244-ksea-instruments-for-endoscopic-fda-510k.jpg K961244 - KSEA INSTRUMENTS FOR ENDOSCOPIC TREATMENT OF CARPAL TUNNEL SYNDROME K961244 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared May 1996. https://www.510kdatabase.net/k935833/ 1996-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k935833-lcx-neisseria-gonorrhoeae-assay-fda-510k.jpg K935833 - LCX NEISSERIA GONORRHOEAE ASSAY K935833 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared May 1996. https://www.510kdatabase.net/k955410/ 1996-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k955410-snapdose-device-fda-510k.jpg K955410 - SNAPDOSE DEVICE K955410 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared May 1996. https://www.510kdatabase.net/k955382/ 1996-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k955382-3m-model-1860-health-care-particulate-fda-510k.jpg K955382 - 3M MODEL 1860 HEALTH CARE PARTICULATE RESPIRATOR TYPE N95 K955382 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared May 1996. https://www.510kdatabase.net/k960757/ 1996-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k960757-karl-storz-ureter-resectoscope-fda-510k.jpg K960757 - KARL STORZ URETER RESECTOSCOPE K960757 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared May 1996. https://www.510kdatabase.net/k952631/ 1996-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k952631-braun-hemodialysis-blood-circuits-fda-510k.jpg K952631 - BRAUN HEMODIALYSIS BLOOD CIRCUITS K952631 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Apr 1996. https://www.510kdatabase.net/k955247/ 1996-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k955247-olympus-kd-series-sphincterotome-fda-510k.jpg K955247 - OLYMPUS KD SERIES SPHINCTEROTOME K955247 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus America, Inc.. Cleared Apr 1996. https://www.510kdatabase.net/k960613/ 1996-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k960613-ge-advantage-windows-review-workstation-fda-510k.jpg K960613 - GE ADVANTAGE WINDOWS REVIEW WORKSTATION K960613 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Apr 1996. https://www.510kdatabase.net/k961135/ 1996-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k961135-input-10f11f-introducer-set01010110f-fda-510k.jpg K961135 - INPUT 10F/11/F INTRODUCER SET(010101(10F), 011101(11F) K961135 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 1996. https://www.510kdatabase.net/k955355/ 1996-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k955355-variant-alpha-thalassemia-short-program-fda-510k.jpg K955355 - VARIANT ALPHA-THALASSEMIA SHORT PROGRAM K955355 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bio-Rad. Cleared Apr 1996. https://www.510kdatabase.net/k960279/ 1996-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k960279-nexgen-compl-knee-sol-legacy-posterior-fda-510k.jpg K960279 - NEXGEN COMPL. KNEE SOL. LEGACY POSTERIOR STABILIZED/CONSTRAINED CONDYLAR KNEE FEMORAL COMPONENTS/ARTICULAR SURFACES K960279 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Apr 1996. https://www.510kdatabase.net/k960548/ 1996-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k960548-ah-plus-root-canal-sealer-fda-510k.jpg K960548 - AH PLUS ROOT CANAL SEALER K960548 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Apr 1996. https://www.510kdatabase.net/k960823/ 1996-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k960823-prime-bond-20-multipurpose-fda-510k.jpg K960823 - PRIME & BOND 2.0 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT K960823 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Apr 1996. https://www.510kdatabase.net/k960275/ 1996-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k960275-opus-ck-mb-total-ck-controls-fda-510k.jpg K960275 - OPUS CK-MB & TOTAL CK CONTROLS K960275 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Apr 1996. https://www.510kdatabase.net/k961211/ 1996-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k961211-argelite-52-fda-510k.jpg K961211 - ARGELITE 52+ K961211 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Apr 1996. https://www.510kdatabase.net/k955422/ 1996-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k955422-axsym-n-acetylprocainamide-fda-510k.jpg K955422 - AXSYM N-ACETYLPROCAINAMIDE K955422 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1996. https://www.510kdatabase.net/k960166/ 1996-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k960166-percor-stat-dl-95-fr-34-40cc-fda-510k.jpg K960166 - PERCOR STAT-DL 9.5 FR. 34 & 40CC K960166 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Apr 1996. https://www.510kdatabase.net/k954683/ 1996-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k954683-questlock-acl-fixator-fda-510k.jpg K954683 - QUESTLOCK ACL FIXATOR K954683 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Apr 1996. https://www.510kdatabase.net/k960720/ 1996-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k960720-exactech-sterile-modular-drill-bit-fda-510k.jpg K960720 - EXACTECH STERILE MODULAR DRILL BIT K960720 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Apr 1996. https://www.510kdatabase.net/k961206/ 1996-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k961206-opus-t3-controls-fda-510k.jpg K961206 - OPUS T3 CONTROLS K961206 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Apr 1996. https://www.510kdatabase.net/k952879/ 1996-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k952879-sarns-centrifugal-pump-with-duraflo-ii-fda-510k.jpg K952879 - SARNS CENTRIFUGAL PUMP WITH DURAFLO II TREATMENT K952879 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Apr 1996. https://www.510kdatabase.net/k960323/ 1996-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k960323-karl-storz-gelet-uretero-fda-510k.jpg K960323 - KARL STORZ GELET URETERO-RENOSCOPES/KARL STORZ ALKEN MOTION CONTROL DEVICE K960323 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Apr 1996. https://www.510kdatabase.net/k955450/ 1996-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k955450-pathromtin-sl-fda-510k.jpg K955450 - PATHROMTIN SL K955450 is a FDA 510(k) cleared hematology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Apr 1996. https://www.510kdatabase.net/k960139/ 1996-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k960139-ge-sterile-angiographic-tray-fda-510k.jpg K960139 - G.E. STERILE ANGIOGRAPHIC TRAY K960139 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: GE Medical Systems. Cleared Apr 1996. https://www.510kdatabase.net/k960294/ 1996-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k960294-phase-conjugate-symmetry-option-for-fda-510k.jpg K960294 - PHASE CONJUGATE SYMMETRY OPTION FOR OUTLOOK K960294 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Apr 1996. https://www.510kdatabase.net/k960516/ 1996-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k960516-fastak-suture-anchor-fda-510k.jpg K960516 - FASTAK SUTURE ANCHOR K960516 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Apr 1996. https://www.510kdatabase.net/k961285/ 1996-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k961285-argedent-40gold-palladium-silver-alloy-fda-510k.jpg K961285 - ARGEDENT 40(GOLD-PALLADIUM-SILVER ALLOY FOR PORCELAIN APPLICATION) K961285 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Apr 1996. https://www.510kdatabase.net/k944459/ 1996-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k944459-accu-chek-instant-plus-g-cdm-blood-fda-510k.jpg K944459 - ACCU-CHEK INSTANT PLUS G-C/DM BLOOD GLUCOSE MONITORING SYSTEM K944459 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Apr 1996. https://www.510kdatabase.net/k952435/ 1996-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k952435-celsite-pediatric-venous-system-fda-510k.jpg K952435 - CELSITE PEDIATRIC VENOUS SYSTEM K952435 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Apr 1996. https://www.510kdatabase.net/k960382/ 1996-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k960382-kodak-digital-science-medical-image-fda-510k.jpg K960382 - KODAK DIGITAL SCIENCE MEDICAL IMAGE MANAGER K960382 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Apr 1996. https://www.510kdatabase.net/k950972/ 1996-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k950972-real-time-reconstruction-system-model-fda-510k.jpg K950972 - REAL-TIME RECONSTRUCTION SYSTEM MODEL TSXF-001A K950972 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Apr 1996. https://www.510kdatabase.net/k951994/ 1996-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k951994-olympus-eu-m30-endoscopic-ultrasound-fda-510k.jpg K951994 - OLYMPUS EU-M30 ENDOSCOPIC ULTRASOUND CENTER K951994 is a FDA 510(k) cleared radiology medical device. Manufacturer: Olympus America, Inc.. Cleared Apr 1996. https://www.510kdatabase.net/k960144/ 1996-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k960144-ge-sterile-ct-biopsy-tray-fda-510k.jpg K960144 - G.E. STERILE CT BIOPSY TRAY K960144 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: GE Medical Systems. Cleared Apr 1996. https://www.510kdatabase.net/k960292/ 1996-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k960292-gore-tex-regenerative-material-fda-510k.jpg K960292 - GORE-TEX REGENERATIVE MATERIAL TITANIUM REINFORCED CONFIGURATIONS K960292 is a FDA 510(k) cleared dental medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Apr 1996. https://www.510kdatabase.net/k954353/ 1996-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k954353-magnetic-resonance-diagnostic-accessory-fda-510k.jpg K954353 - MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY K954353 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Apr 1996. https://www.510kdatabase.net/k954354/ 1996-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k954354-magnetic-resonance-diagnostic-accessory-fda-510k.jpg K954354 - MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY K954354 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Apr 1996. https://www.510kdatabase.net/k960406/ 1996-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k960406-braun-hemostasis-introducers-fda-510k.jpg K960406 - BRAUN HEMOSTASIS INTRODUCERS K960406 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Apr 1996. https://www.510kdatabase.net/k951343/ 1996-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k951343-karl-storz-semi-rigid-micro-endoscopes-fda-510k.jpg K951343 - KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES & ACCESSORIES FOR ENDOSCCOPIC GYNECOLOGICAL SURGICAL PROCEDURES K951343 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Apr 1996. https://www.510kdatabase.net/k955306/ 1996-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k955306-omega-compression-screw-system-fda-510k.jpg K955306 - OMEGA+ COMPRESSION SCREW SYSTEM K955306 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Apr 1996. https://www.510kdatabase.net/k960805/ 1996-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k960805-arthoscope-fda-510k.jpg K960805 - ARTHOSCOPE K960805 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Apr 1996. https://www.510kdatabase.net/k955944/ 1996-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k955944-osteonics-n2vac-packaging-process-fda-510k.jpg K955944 - OSTEONICS N2/VAC PACKAGING PROCESS K955944 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Apr 1996. https://www.510kdatabase.net/k960143/ 1996-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k960143-ge-sterile-digital-angiographic-tray-fda-510k.jpg K960143 - G.E. STERILE DIGITAL ANGIOGRAPHIC TRAY K960143 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: GE Medical Systems. Cleared Apr 1996. https://www.510kdatabase.net/k960501/ 1996-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k960501-ultra-thin-diamond-balloon-dilatation-fda-510k.jpg K960501 - ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER K960501 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Apr 1996. https://www.510kdatabase.net/k960517/ 1996-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k960517-bard-tru-trac-peripheral-balloon-fda-510k.jpg K960517 - BARD TRU-TRAC PERIPHERAL BALLOON DILATATION CATHETER K960517 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 1996. https://www.510kdatabase.net/k955327/ 1996-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k955327-hp-sonos-100cf-ultrasound-imaging-system-fda-510k.jpg K955327 - HP SONOS 100CF ULTRASOUND IMAGING SYSTEM K955327 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Apr 1996. https://www.510kdatabase.net/k950157/ 1996-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k950157-siemens-q64xxx-fda-510k.jpg K950157 - SIEMENS Q64XXX K950157 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 1996. https://www.510kdatabase.net/k960476/ 1996-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k960476-ethicon-bipolar-scissors-and-accessory-fda-510k.jpg K960476 - ETHICON BIPOLAR SCISSORS AND ACCESSORY CABLE K960476 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Apr 1996. https://www.510kdatabase.net/k960748/ 1996-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k960748-modified-hand-instrument-devices-fda-510k.jpg K960748 - MODIFIED HAND INSTRUMENT DEVICES K960748 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Apr 1996. https://www.510kdatabase.net/k961188/ 1996-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k961188-cefepime-30-mcg-sensi-disc-fda-510k.jpg K961188 - CEFEPIME, 30 MCG, SENSI-DISC K961188 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1996. https://www.510kdatabase.net/k954598/ 1996-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k954598-osteonics-offset-hip-stems-fda-510k.jpg K954598 - OSTEONICS OFFSET HIP STEMS K954598 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Apr 1996. https://www.510kdatabase.net/k955398/ 1996-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k955398-formulation-preparation-device-fda-510k.jpg K955398 - FORMULATION PREPARATION DEVICE K955398 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Apr 1996. https://www.510kdatabase.net/k960269/ 1996-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k960269-titanium-universal-clamp-fda-510k.jpg K960269 - TITANIUM UNIVERSAL CLAMP K960269 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Apr 1996. https://www.510kdatabase.net/k960509/ 1996-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k960509-18-gauge-tru-cut-biopsy-needle-fda-510k.jpg K960509 - 18 GAUGE TRU-CUT BIOPSY NEEDLE K960509 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Apr 1996. https://www.510kdatabase.net/k955677/ 1996-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k955677-synchron-systems-cannabinoid-20-ng-fda-510k.jpg K955677 - SYNCHRON SYSTEMS CANNABINOID 20 NG REAGENT K955677 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Apr 1996. https://www.510kdatabase.net/k960635/ 1996-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k960635-pulmo-ct-with-reference-database-for-fda-510k.jpg K960635 - PULMO CT WITH REFERENCE DATABASE FOR THE SOMATOM PLUS AND PLUS 4 COMPUTED TOMOGRAPHY SYSTEMS K960635 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 1996. https://www.510kdatabase.net/k955444/ 1996-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k955444-abbott-axsm-procainamide-assay-fda-510k.jpg K955444 - ABBOTT AXSM PROCAINAMIDE ASSAY K955444 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1996. https://www.510kdatabase.net/k960975/ 1996-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k960975-1-4f-infiniti-angiographic-catheter-fda-510k.jpg K960975 - 1-4F INFINITI ANGIOGRAPHIC CATHETER K960975 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Apr 1996. https://www.510kdatabase.net/k954451/ 1996-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k954451-evis-140-system-fda-510k.jpg K954451 - EVIS 140 SYSTEM K954451 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus America, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k955484/ 1996-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k955484-xenon-option-to-prism-3000-fda-510k.jpg K955484 - XENON OPTION TO PRISM 3000 K955484 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k955650/ 1996-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k955650-olympus-sd-series-snares-fda-510k.jpg K955650 - OLYMPUS SD SERIES SNARES K955650 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus America, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k955811/ 1996-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k955811-auxiliary-patient-tablemagnetom-open-fda-510k.jpg K955811 - AUXILIARY PATIENT TABLE/MAGNETOM OPEN SYSTEM K955811 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k955831/ 1996-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k955831-argyle-aspr-care-closed-suction-system-fda-510k.jpg K955831 - ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM K955831 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sherwood Medical Co.. Cleared Mar 1996. https://www.510kdatabase.net/k960653/ 1996-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k960653-monocryl-poliglecaprone-25-suture-dyed-fda-510k.jpg K960653 - MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED) K960653 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k960172/ 1996-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k960172-depuy-porocoat-hps-ii-hip-prosthesis-fda-510k.jpg K960172 - DEPUY POROCOAT HPS II HIP PROSTHESIS W/ARTICUL-EZE TAPER K960172 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k960385/ 1996-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k960385-sterile-kirschner-wires-and-steinmann-fda-510k.jpg K960385 - STERILE KIRSCHNER WIRES AND STEINMANN PINS K960385 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k960538/ 1996-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k960538-opteon-unipolar-fda-510k.jpg K960538 - OPTEON UNIPOLAR K960538 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k955820/ 1996-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k955820-braun-hemostasis-introducers-fda-510k.jpg K955820 - BRAUN HEMOSTASIS INTRODUCERS K955820 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k955832/ 1996-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k955832-cordis-ventricular-antechamber-va-fda-510k.jpg K955832 - CORDIS VENTRICULAR ANTECHAMBER (VA) K955832 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cordis Corp.. Cleared Mar 1996. https://www.510kdatabase.net/k954963/ 1996-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k954963-schuhli-implant-system-fda-510k.jpg K954963 - SCHUHLI IMPLANT SYSTEM K954963 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Mar 1996. https://www.510kdatabase.net/k955871/ 1996-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k955871-howmedica-asymmetric-stem-femoral-fda-510k.jpg K955871 - HOWMEDICA ASYMMETRIC STEM FEMORAL COMPONENT K955871 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Mar 1996. https://www.510kdatabase.net/k960524/ 1996-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k960524-alta-cfx-im-rod-system-fda-510k.jpg K960524 - ALTA CFX IM ROD SYSTEM K960524 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Mar 1996. https://www.510kdatabase.net/k955587/ 1996-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k955587-vascular-access-port-kit-fda-510k.jpg K955587 - VASCULAR ACCESS PORT KIT K955587 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Boston Scientific Corp. Cleared Mar 1996. https://www.510kdatabase.net/k960602/ 1996-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k960602-ssa-340a-modification-fda-510k.jpg K960602 - SSA-340A (MODIFICATION) K960602 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Mar 1996. https://www.510kdatabase.net/k955021/ 1996-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k955021-quanta-lite-pr3-fda-510k.jpg K955021 - QUANTA LITE PR3 K955021 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k955022/ 1996-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k955022-quanta-lite-mpo-fda-510k.jpg K955022 - QUANTA LITE MPO K955022 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k960090/ 1996-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k960090-calcofluor-white-stain-kit-fda-510k.jpg K960090 - CALCOFLUOR WHITE STAIN KIT K960090 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Mar 1996. https://www.510kdatabase.net/k960095/ 1996-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k960095-bactidrop-calcofluor-white-fda-510k.jpg K960095 - BACTIDROP CALCOFLUOR WHITE K960095 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Mar 1996. https://www.510kdatabase.net/k951185/ 1996-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k951185-nexgen-complete-knee-solution-9mm-fda-510k.jpg K951185 - NEXGEN COMPLETE KNEE SOLUTION 9MM ARTICULAR SURFACE K951185 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k953752/ 1996-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k953752-rt55-diagnostic-ultrasound-system-fda-510k.jpg K953752 - RT55 DIAGNOSTIC ULTRASOUND SYSTEM K953752 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Mar 1996. https://www.510kdatabase.net/k960203/ 1996-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k960203-ge-sterile-amniocentesis-tray-fda-510k.jpg K960203 - G.E. STERILE AMNIOCENTESIS TRAY K960203 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: GE Medical Systems. Cleared Mar 1996. https://www.510kdatabase.net/k943025/ 1996-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k943025-freemansamuelson-total-knee-system-fda-510k.jpg K943025 - FREEMAN/SAMUELSON TOTAL KNEE SYSTEM K943025 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k955720/ 1996-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k955720-amax-cs-190-coagulation-analyzer-system-fda-510k.jpg K955720 - AMAX CS-190 COAGULATION ANALYZER SYSTEM K955720 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k955884/ 1996-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k955884-coordinate-revision-knee-system-fda-510k.jpg K955884 - COORDINATE REVISION KNEE SYSTEM K955884 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k960154/ 1996-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k960154-psa-controls-fda-510k.jpg K960154 - PSA CONTROLS K960154 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Mar 1996. https://www.510kdatabase.net/k955724/ 1996-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k955724-kc-1a-coagulation-analyzerset-fda-510k.jpg K955724 - KC 1A COAGULATION ANALYZER/SET K955724 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k955785/ 1996-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k955785-ts-percutaneous-arterialvenus-catheter-fda-510k.jpg K955785 - TS PERCUTANEOUS ARTERIAL/VENUS CATHETER INTRO SET K955785 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k960129/ 1996-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k960129-sas-salmonella-o-group-y-factor-48-fda-510k.jpg K960129 - SAS SALMONELLA O GROUP Y FACTOR 48 ANTISERUM K960129 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k960130/ 1996-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k960130-sas-salmonella-o-group-z-factor-50-fda-510k.jpg K960130 - SAS SALMONELLA O GROUP Z FACTOR 50 ANTISERUM K960130 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k960147/ 1996-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k960147-sas-salmonella-0-group-e-factors-fda-510k.jpg K960147 - SAS SALMONELLA 0 GROUP E FACTORS 1,3,10,15,19,34 ANTISERUM K960147 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k960160/ 1996-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k960160-sas-salmonella-0-group-m-factor-28-fda-510k.jpg K960160 - SAS SALMONELLA 0 GROUP M FACTOR 28 ANTISERUM K960160 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k960461/ 1996-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k960461-sas-salmonella-o-group-r-factor-40-fda-510k.jpg K960461 - SAS SALMONELLA O GROUP R FACTOR 40 ANTISERUM K960461 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k952321/ 1996-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k952321-porcine-factor-viii-fda-510k.jpg K952321 - PORCINE FACTOR VIII K952321 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Mar 1996. https://www.510kdatabase.net/k952540/ 1996-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k952540-sonos-imaging-system-20002500-10001500-fda-510k.jpg K952540 - SONOS IMAGING SYSTEM (2000/2500 & 1000/1500) K952540 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Mar 1996. https://www.510kdatabase.net/k953750/ 1996-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k953750-catheter-electrode-recording-or-probe-fda-510k.jpg K953750 - CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING K953750 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Mar 1996. https://www.510kdatabase.net/k955403/ 1996-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k955403-oes-laparo-thoraco-videoscope-type-v-fda-510k.jpg K955403 - OES LAPARO-THORACO VIDEOSCOPE TYPE V K955403 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Olympus America, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k955532/ 1996-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k955532-diastat-vascular-access-graft-fda-510k.jpg K955532 - DIASTAT VASCULAR ACCESS GRAFT K955532 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k955735/ 1996-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k955735-kc-4a-micro-coagulation-analyzer-fda-510k.jpg K955735 - KC 4A MICRO COAGULATION ANALYZER SET/SYSTEM K955735 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k955886/ 1996-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k955886-mega-pta-balloon-catheter-fda-510k.jpg K955886 - MEGA PTA BALLOON CATHETER K955886 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Mar 1996. https://www.510kdatabase.net/k960266/ 1996-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k960266-siregraph-cf-fda-510k.jpg K960266 - SIREGRAPH CF K960266 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k960791/ 1996-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k960791-karl-storz-huzly-high-frequency-fda-510k.jpg K960791 - KARL STORZ HUZLY HIGH-FREQUENCY CUTTING LOOPS K960791 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k932330/ 1996-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k932330-ti-6al-7nb-urtn-fda-510k.jpg K932330 - TI-6AL-7NB URTN K932330 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Mar 1996. https://www.510kdatabase.net/k945518/ 1996-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k945518-pfc-2-total-hip-system-porous-coated-fda-510k.jpg K945518 - P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENT K945518 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k953607/ 1996-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k953607-titanium-limited-contact-dynamic-hip-fda-510k.jpg K953607 - TITANIUM LIMITED CONTACT DYNAMIC HIP SCREW PLATE (TILC-DHS) K953607 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Mar 1996. https://www.510kdatabase.net/k953644/ 1996-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k953644-volar-distal-radius-plate-fda-510k.jpg K953644 - VOLAR DISTAL RADIUS PLATE K953644 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Mar 1996. https://www.510kdatabase.net/k953777/ 1996-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k953777-synthes-wire-mount-fda-510k.jpg K953777 - SYNTHES WIRE MOUNT K953777 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Mar 1996. https://www.510kdatabase.net/k953806/ 1996-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k953806-synthes-usa-midfacial-system-fda-510k.jpg K953806 - SYNTHES (USA) MIDFACIAL SYSTEM K953806 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Mar 1996. https://www.510kdatabase.net/k954385/ 1996-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k954385-synthes-mandibular-modular-fixation-fda-510k.jpg K954385 - SYNTHES MANDIBULAR MODULAR FIXATION SYSTEM K954385 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Mar 1996. https://www.510kdatabase.net/k954429/ 1996-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k954429-kangaroo-entristar-skin-level-fda-510k.jpg K954429 - KANGAROO ENTRISTAR SKIN-LEVEL GASTROSTOMY KIT K954429 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Sherwood Medical Co.. Cleared Mar 1996. https://www.510kdatabase.net/k954856/ 1996-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k954856-cannulated-femoral-nail-fda-510k.jpg K954856 - CANNULATED FEMORAL NAIL K954856 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Mar 1996. https://www.510kdatabase.net/k960222/ 1996-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k960222-percutaneous-endoscopic-discectomy-fda-510k.jpg K960222 - PERCUTANEOUS ENDOSCOPIC DISCECTOMY K960222 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Mar 1996. https://www.510kdatabase.net/k953391/ 1996-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k953391-treatment-management-system-fda-510k.jpg K953391 - TREATMENT MANAGEMENT SYSTEM K953391 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k954394/ 1996-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k954394-aesculap-ventriculoscope-system-fda-510k.jpg K954394 - AESCULAP VENTRICULOSCOPE SYSTEM K954394 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k955025/ 1996-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k955025-axsym-progesterone-fda-510k.jpg K955025 - AXSYM PROGESTERONE K955025 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1996. https://www.510kdatabase.net/k960473/ 1996-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k960473-aesculap-power-system-handpiece-fda-510k.jpg K960473 - AESCULAP POWER SYSTEM HANDPIECE K960473 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k944458/ 1996-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k944458-accu-chek-instant-plus-choloesterol-test-fda-510k.jpg K944458 - ACCU-CHEK INSTANT PLUS CHOLOESTEROL TEST K944458 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Mar 1996. https://www.510kdatabase.net/k954496/ 1996-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k954496-frontline-cocaine-fda-510k.jpg K954496 - FRONTLINE COCAINE K954496 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Mar 1996. https://www.510kdatabase.net/k954497/ 1996-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k954497-frontline-cannabis-fda-510k.jpg K954497 - FRONTLINE CANNABIS K954497 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Mar 1996. https://www.510kdatabase.net/k954498/ 1996-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k954498-frontline-opiates-fda-510k.jpg K954498 - FRONTLINE OPIATES K954498 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Mar 1996. https://www.510kdatabase.net/k960123/ 1996-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k960123-sas-salmonella-o-factor-18-antiserum-fda-510k.jpg K960123 - SAS SALMONELLA O FACTOR 18 ANTISERUM &/OR SAS SALMONELLA O GROUP K FACTOR 18 ANTISERUM K960123 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k960124/ 1996-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k960124-sas-salmonella-0-factor-10-antiserum-fda-510k.jpg K960124 - SAS SALMONELLA 0 FACTOR 10 ANTISERUM AND/OR SAS SALMONELLA 0 GROUP E1 FACTOR 10 ANTISERUM K960124 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k960125/ 1996-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k960125-sas-salmonella-o-factor-4-antiserum-or-fda-510k.jpg K960125 - SAS SALMONELLA O FACTOR 4 ANTISERUM &/OR SAS SALMONELLA O GROUP B FACTOR 4,5 ANTISERUM K960125 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k960126/ 1996-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k960126-sas-salmonella-o-factor-19-antiserum-fda-510k.jpg K960126 - SAS SALMONELLA O FACTOR 19 ANTISERUM &/OR SAS SALMONELLA O GROUP E4 FACTOR 19 ANTISERUM K960126 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k960127/ 1996-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k960127-sas-salmonella-o-factor-22-antiserum-fda-510k.jpg K960127 - SAS SALMONELLA O FACTOR 22 ANTISERUM &/OR SAS SALMONELLA O GROUP G1 FACTOR 22 ANTISERUM K960127 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k960132/ 1996-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k960132-sas-salmonella-h-u-antiserum-fda-510k.jpg K960132 - SAS SALMONELLA H U ANTISERUM K960132 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k960134/ 1996-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k960134-sas-salmonella-0-factor-9-antiserum-fda-510k.jpg K960134 - SAS SALMONELLA 0 FACTOR 9 ANTISERUM AND/OR SAS SALMONELLA 0 GROUP D FACTOR 9 ANTISERUM K960134 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k960135/ 1996-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k960135-sas-salmonella-h-m-antiserum-fda-510k.jpg K960135 - SAS SALMONELLA H M ANTISERUM K960135 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k960136/ 1996-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k960136-sas-salmonella-h-p-antiserum-fda-510k.jpg K960136 - SAS SALMONELLA H P ANTISERUM K960136 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k960137/ 1996-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k960137-sas-salmonella-h-z10-antiserum-fda-510k.jpg K960137 - SAS SALMONELLA H Z10 ANTISERUM K960137 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k960138/ 1996-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k960138-sas-salmonella-0-factor-8-antiserum-fda-510k.jpg K960138 - SAS SALMONELLA 0 FACTOR 8 ANTISERUM AND/OR SAS SALMONELLA 0 GROUP C2 FACTOR 9 ANTISERUM K960138 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k960140/ 1996-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k960140-sas-salmonella-0-factor-antiserum-fda-510k.jpg K960140 - SAS SALMONELLA 0 FACTOR ANTISERUM AND/OR SAS SALMONELLA 0 GROUP C1 FACTOR 7 ANTISERUM K960140 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k960142/ 1996-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k960142-sas-salmonella-0-factor-23-antiserum-fda-510k.jpg K960142 - SAS SALMONELLA 0 FACTOR 23 ANTISERUM AND/OR SAS SLAMONELLA 0 GROUP G2 FACTOR 23 ANTISERUM K960142 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k960145/ 1996-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k960145-sas-salmonella-0-factor-27-antiserum-fda-510k.jpg K960145 - SAS SALMONELLA 0 FACTOR 27 ANTISERUM K960145 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k960149/ 1996-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k960149-sas-salmonella-0-group-f-factor-11-fda-510k.jpg K960149 - SAS SALMONELLA 0 GROUP F FACTOR 11 ANTISERUM K960149 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k960150/ 1996-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k960150-sas-salmonella-0-group-j-factor-17-fda-510k.jpg K960150 - SAS SALMONELLA 0 GROUP J FACTOR 17 ANTISERUM K960150 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k960152/ 1996-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k960152-sas-salmonella-0-factor-12-antiserum-fda-510k.jpg K960152 - SAS SALMONELLA 0 FACTOR 12 ANTISERUM K960152 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k960153/ 1996-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k960153-sas-salomnella-0-group-l-factor-21-fda-510k.jpg K960153 - SAS SALOMNELLA 0 GROUP L FACTOR 21 ANTISERUM K960153 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k960161/ 1996-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k960161-sas-salmonella-0-group-n-factor-30-fda-510k.jpg K960161 - SAS SALMONELLA 0 GROUP N FACTOR 30 ANTISERUM K960161 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k960162/ 1996-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k960162-sas-salmonella-0-group-0-factor-35-fda-510k.jpg K960162 - SAS SALMONELLA 0 GROUP 0 FACTOR 35 ANTISERUM K960162 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k960163/ 1996-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k960163-sas-salmonella-0-factor-factor-5-fda-510k.jpg K960163 - SAS SALMONELLA 0 FACTOR FACTOR 5 ANTISERUM K960163 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k960458/ 1996-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k960458-sas-salmonella-o-group-t-factor-42-fda-510k.jpg K960458 - SAS SALMONELLA O GROUP T FACTOR 42 ANTISERUM K960458 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k960459/ 1996-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k960459-sas-salmonella-o-group-s-factor-41-fda-510k.jpg K960459 - SAS SALMONELLA O GROUP S FACTOR 41 ANTISERUM K960459 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k960460/ 1996-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k960460-sas-salmonella-o-factor-46-antiserum-fda-510k.jpg K960460 - SAS SALMONELLA O FACTOR 46 ANTISERUM K960460 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k960462/ 1996-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k960462-sas-salmonella-o-group-q-factor-39-fda-510k.jpg K960462 - SAS SALMONELLA O GROUP Q FACTOR 39 ANTISERUM K960462 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k960463/ 1996-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k960463-sas-salmonella-o-group-u-factor-43-fda-510k.jpg K960463 - SAS SALMONELLA O GROUP U FACTOR 43 ANTISERUM K960463 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k960465/ 1996-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k960465-sas-salmonella-o-group-p-factor-38-fda-510k.jpg K960465 - SAS SALMONELLA O GROUP P FACTOR 38 ANTISERUM K960465 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k955559/ 1996-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k955559-corometrics-fetal-movement-detection-kit-fda-510k.jpg K955559 - COROMETRICS FETAL MOVEMENT DETECTION KIT K955559 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Mar 1996. https://www.510kdatabase.net/k955731/ 1996-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k955731-osteonics-shoulder-humeral-components-fda-510k.jpg K955731 - OSTEONICS SHOULDER HUMERAL COMPONENTS K955731 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Mar 1996. https://www.510kdatabase.net/k955676/ 1996-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k955676-synchron-systems-methaqualone-reagent-fda-510k.jpg K955676 - SYNCHRON SYSTEMS METHAQUALONE REAGENT K955676 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k955837/ 1996-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k955837-cannulated-plus-hip-screw-sterile-fda-510k.jpg K955837 - CANNULATED PLUS HIP SCREW (STERILE) K955837 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Mar 1996. https://www.510kdatabase.net/k960131/ 1996-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k960131-sas-salmonella-h-g-antiserum-fda-510k.jpg K960131 - SAS SALMONELLA H G ANTISERUM K960131 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k960133/ 1996-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k960133-sas-salmonella-h-f-antiserum-fda-510k.jpg K960133 - SAS SALMONELLA H F ANTISERUM K960133 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k960331/ 1996-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k960331-sas-salmonella-h-z28-antiserum-fda-510k.jpg K960331 - SAS SALMONELLA H Z28 ANTISERUM K960331 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k960333/ 1996-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k960333-sas-salmonella-h-gpu-antiserum-fda-510k.jpg K960333 - SAS SALMONELLA H G,P,U ANTISERUM K960333 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k960335/ 1996-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k960335-sas-salmonella-h-poly-a-z-antiserum-fda-510k.jpg K960335 - SAS SALMONELLA H POLY A-Z ANTISERUM K960335 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k960603/ 1996-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k960603-sas-salmonella-h-z23-antiserum-fda-510k.jpg K960603 - SAS SALMONELLA H Z23 ANTISERUM K960603 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k960609/ 1996-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k960609-sas-salmonella-h-z32-antiserum-fda-510k.jpg K960609 - SAS SALMONELLA H Z32 ANTISERUM K960609 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k960610/ 1996-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k960610-sas-salmonella-h-z15-antiserum-fda-510k.jpg K960610 - SAS SALMONELLA H Z15 ANTISERUM K960610 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k945782/ 1996-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k945782-humidifier-fda-510k.jpg K945782 - HUMIDIFIER K945782 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Mar 1996. https://www.510kdatabase.net/k960028/ 1996-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k960028-orthoralix-sd2-s-panoramic-dental-x-fda-510k.jpg K960028 - ORTHORALIX SD2 & S PANORAMIC DENTAL X-RAY SYSTEM K960028 is a FDA 510(k) cleared radiology medical device. Manufacturer: Dentsply Intl.. Cleared Mar 1996. https://www.510kdatabase.net/k952262/ 1996-02-29 monthly 0.5 https://www.510kdatabase.net/og-image/k952262-speedband-fda-510k.jpg K952262 - SPEEDBAND K952262 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Feb 1996. https://www.510kdatabase.net/k953127/ 1996-02-29 monthly 0.5 https://www.510kdatabase.net/og-image/k953127-accustress-exercise-testing-system-fda-510k.jpg K953127 - ACCUSTRESS EXERCISE TESTING SYSTEM K953127 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Feb 1996. https://www.510kdatabase.net/k953568/ 1996-02-29 monthly 0.5 https://www.510kdatabase.net/og-image/k953568-codman-fiducial-marker-system-fda-510k.jpg K953568 - CODMAN FIDUCIAL MARKER SYSTEM K953568 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k954380/ 1996-02-29 monthly 0.5 https://www.510kdatabase.net/og-image/k954380-quanta-lite-ssdna-fda-510k.jpg K954380 - QUANTA LITE SSDNA K954380 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k954840/ 1996-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k954840-alkaline-phosphatase-alp-procedure-no-fda-510k.jpg K954840 - ALKALINE PHOSPHATASE (ALP) PROCEDURE NO. 245 K954840 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k954719/ 1996-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k954719-intermedics-model-430-07-bipolar-fda-510k.jpg K954719 - INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD K954719 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k954808/ 1996-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k954808-ussc-polyproplene-suture-fda-510k.jpg K954808 - USSC POLYPROPLENE SUTURE K954808 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Feb 1996. https://www.510kdatabase.net/k955747/ 1996-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k955747-ussc-nonabsorbable-sutures-fda-510k.jpg K955747 - USSC NONABSORBABLE SUTURES K955747 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Feb 1996. https://www.510kdatabase.net/k960146/ 1996-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k960146-ge-sterile-disposable-radiographic-fda-510k.jpg K960146 - G.E. STERILE DISPOSABLE RADIOGRAPHIC CONTRAST TRAY K960146 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Feb 1996. https://www.510kdatabase.net/k960204/ 1996-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k960204-ge-sterile-percutaneous-fda-510k.jpg K960204 - G.E. STERILE, PERCUTANEOUS CHOLANGIOGRAPHIC TRAY K960204 is a FDA 510(k) cleared general hospital medical device. Manufacturer: GE Medical Systems. Cleared Feb 1996. https://www.510kdatabase.net/k954208/ 1996-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k954208-optetrak-constrained-condylar-knee-for-fda-510k.jpg K954208 - OPTETRAK CONSTRAINED CONDYLAR KNEE FOR CEMENTED USE ONLY K954208 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k954874/ 1996-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k954874-spectef-protocol-fda-510k.jpg K954874 - SPECTEF PROTOCOL K954874 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Feb 1996. https://www.510kdatabase.net/k960477/ 1996-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k960477-ventilation-tubes-fda-510k.jpg K960477 - VENTILATION TUBES K960477 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k950671/ 1996-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k950671-immulite-toxoplasma-gondii-igg-fda-510k.jpg K950671 - IMMULITE TOXOPLASMA GONDII IGG K950671 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Feb 1996. https://www.510kdatabase.net/k953118/ 1996-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k953118-caracell-fda-510k.jpg K953118 - CARACELL K953118 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Medtronic Vascular. Cleared Feb 1996. https://www.510kdatabase.net/k955448/ 1996-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k955448-emit-ii-lsd-assay-emit-lsd-calibrators-fda-510k.jpg K955448 - EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLS K955448 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955468/ 1996-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k955468-opus-prolactin-controls-fda-510k.jpg K955468 - OPUS PROLACTIN CONTROLS K955468 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955485/ 1996-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k955485-brun-selective-and-flush-angiographic-fda-510k.jpg K955485 - BRUN SELECTIVE AND FLUSH ANGIOGRAPHIC CATHETERS K955485 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955669/ 1996-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k955669-remel-cefepime-30-ug-susceptibility-disk-fda-510k.jpg K955669 - REMEL CEFEPIME 30 UG SUSCEPTIBILITY DISK K955669 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Feb 1996. https://www.510kdatabase.net/k955456/ 1996-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k955456-oes-laparo-thoraco-videoscope-rigid-fda-510k.jpg K955456 - OES LAPARO-THORACO VIDEOSCOPE (RIGID) K955456 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Olympus America, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955381/ 1996-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k955381-b-braum-angiographicangioplasty-kit-fda-510k.jpg K955381 - B. BRAUM ANGIOGRAPHIC/ANGIOPLASTY KIT K955381 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955394/ 1996-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k955394-sienet-teleradiology-product-line-fda-510k.jpg K955394 - SIENET TELERADIOLOGY PRODUCT LINE K955394 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955421/ 1996-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k955421-osteonics-n2vac-packaging-process-fda-510k.jpg K955421 - OSTEONICS N2/VAC PACKAGING PROCESS K955421 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Feb 1996. https://www.510kdatabase.net/k955857/ 1996-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k955857-n-protein-standars-sy-fda-510k.jpg K955857 - N PROTEIN STANDARS SY K955857 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955858/ 1996-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k955858-nt-protein-control-syl-m-and-h-fda-510k.jpg K955858 - N/T PROTEIN CONTROL SY/L, M AND H K955858 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k960011/ 1996-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k960011-endoscopic-needle-driver-fda-510k.jpg K960011 - ENDOSCOPIC NEEDLE DRIVER K960011 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Feb 1996. https://www.510kdatabase.net/k960141/ 1996-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k960141-ge-sterile-standard-biopsy-tray-fda-510k.jpg K960141 - G.E. STERILE, STANDARD BIOPSY TRAY K960141 is a FDA 510(k) cleared general hospital medical device. Manufacturer: GE Medical Systems. Cleared Feb 1996. https://www.510kdatabase.net/k960201/ 1996-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k960201-ge-sterile-breast-biopsylocalization-fda-510k.jpg K960201 - G.E. STERILE BREAST BIOPSY/LOCALIZATION TRAY K960201 is a FDA 510(k) cleared general hospital medical device. Manufacturer: GE Medical Systems. Cleared Feb 1996. https://www.510kdatabase.net/k960202/ 1996-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k960202-ge-sterile-puncture-tray-fda-510k.jpg K960202 - G.E. STERILE PUNCTURE TRAY K960202 is a FDA 510(k) cleared general hospital medical device. Manufacturer: GE Medical Systems. Cleared Feb 1996. https://www.510kdatabase.net/k955277/ 1996-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k955277-arterial-blood-tubing-set-for-single-fda-510k.jpg K955277 - ARTERIAL BLOOD TUBING SET FOR SINGLE NEEDLE HEMODIALYSIS K955277 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Feb 1996. https://www.510kdatabase.net/k955347/ 1996-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k955347-ultraflex-fda-510k.jpg K955347 - ULTRAFLEX K955347 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Feb 1996. https://www.510kdatabase.net/k955348/ 1996-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k955348-titanium-moss-miami-spinal-system-fda-510k.jpg K955348 - TITANIUM MOSS MIAMI SPINAL SYSTEM K955348 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955350/ 1996-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k955350-bimetric-cocr-headneck-replacement-hip-fda-510k.jpg K955350 - BIMETRIC COCR HEAD/NECK REPLACEMENT HIP STEM K955350 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955376/ 1996-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k955376-immulite-hgh-fda-510k.jpg K955376 - IMMULITE HGH K955376 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Feb 1996. https://www.510kdatabase.net/k955473/ 1996-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k955473-gamma-system-fda-510k.jpg K955473 - GAMMA SYSTEM K955473 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955644/ 1996-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k955644-synchron-systems-carbamazepine-test-fda-510k.jpg K955644 - SYNCHRON SYSTEMS CARBAMAZEPINE TEST SYSTEM K955644 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955716/ 1996-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k955716-vancomycin-fpia-reagent-set-fda-510k.jpg K955716 - VANCOMYCIN FPIA REAGENT SET K955716 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k960066/ 1996-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k960066-immulite-acth-fda-510k.jpg K960066 - IMMULITE ACTH K960066 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Feb 1996. https://www.510kdatabase.net/k953915/ 1996-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k953915-moss-miami-spinal-system-anterior-use-fda-510k.jpg K953915 - MOSS MIAMI SPINAL SYSTEM (ANTERIOR USE) K953915 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k954833/ 1996-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k954833-accu-chek-advantage-test-strips-fda-510k.jpg K954833 - ACCU-CHEK ADVANTAGE TEST STRIPS K954833 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Feb 1996. https://www.510kdatabase.net/k945028/ 1996-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k945028-finn-knee-system-fda-510k.jpg K945028 - FINN KNEE SYSTEM K945028 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k952667/ 1996-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k952667-chrom-z-heparin-cat-no-5242-fda-510k.jpg K952667 - CHROM Z-HEPARIN, CAT. NO 5242 K952667 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Feb 1996. https://www.510kdatabase.net/k952776/ 1996-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k952776-lfic-or-fetto-hip-fda-510k.jpg K952776 - LFIC OR FETTO HIP K952776 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k954537/ 1996-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k954537-olympus-c-reactive-protein-fda-510k.jpg K954537 - OLYMPUS C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC REAGENT K954537 is a FDA 510(k) cleared immunology medical device. Manufacturer: Olympus America, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k954652/ 1996-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k954652-aesculap-endosccopic-spine-instruments-fda-510k.jpg K954652 - AESCULAP ENDOSCCOPIC SPINE INSTRUMENTS K954652 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aesculap, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955640/ 1996-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k955640-lorenz-mandibular-distractor-fda-510k.jpg K955640 - LORENZ MANDIBULAR DISTRACTOR K955640 is a FDA 510(k) cleared dental medical device. Manufacturer: Biomet, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955793/ 1996-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k955793-il-bgge-blood-gas-with-glucose-system-fda-510k.jpg K955793 - IL BGGE BLOOD GAS WITH GLUCOSE SYSTEM K955793 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Feb 1996. https://www.510kdatabase.net/k955868/ 1996-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k955868-boehringer-mannheim-cardiac-t-tropnin-t-fda-510k.jpg K955868 - BOEHRINGER MANNHEIM CARDIAC T TROPNIN T K955868 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Feb 1996. https://www.510kdatabase.net/k960067/ 1996-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k960067-immilite-total-ige-fda-510k.jpg K960067 - IMMILITE TOTAL IGE K960067 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Feb 1996. https://www.510kdatabase.net/k953847/ 1996-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k953847-roche-reagent-for-glucose-fda-510k.jpg K953847 - ROCHE REAGENT FOR GLUCOSE K953847 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955222/ 1996-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k955222-sas-spicer-edwards-1-complex-fda-510k.jpg K955222 - SAS SPICER-EDWARDS 1 COMPLEX K955222 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955223/ 1996-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k955223-sas-spicer-edwards-1-antiserum-fda-510k.jpg K955223 - SAS SPICER-EDWARDS 1 ANTISERUM K955223 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955224/ 1996-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k955224-sas-spicer-edwards-2-antiserum-fda-510k.jpg K955224 - SAS SPICER-EDWARDS 2 ANTISERUM K955224 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955225/ 1996-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k955225-sas-spicer-edwards-3-antiserum-fda-510k.jpg K955225 - SAS SPICER-EDWARDS 3 ANTISERUM K955225 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955226/ 1996-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k955226-sas-spicer-edwards-4-antiserum-fda-510k.jpg K955226 - SAS SPICER-EDWARDS 4 ANTISERUM K955226 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955227/ 1996-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k955227-sas-spicer-edwards-en-complex-antiserum-fda-510k.jpg K955227 - SAS SPICER-EDWARDS EN COMPLEX ANTISERUM K955227 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955228/ 1996-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k955228-sas-spicer-edwards-l-complex-fda-510k.jpg K955228 - SAS SPICER-EDWARDS L COMPLEX K955228 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955623/ 1996-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k955623-olympus-bipolar-forceps-fda-510k.jpg K955623 - OLYMPUS BIPOLAR FORCEPS K955623 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Olympus America, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k952892/ 1996-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k952892-olympus-ultrasonic-probe-for-esophogus-fda-510k.jpg K952892 - OLYMPUS ULTRASONIC PROBE FOR ESOPHOGUS (MH-908) K952892 is a FDA 510(k) cleared radiology medical device. Manufacturer: Olympus America, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955139/ 1996-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k955139-olympus-unsaturated-iron-binding-fda-510k.jpg K955139 - OLYMPUS UNSATURATED IRON BINDING CAPACITY REAGENT K955139 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus America, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955235/ 1996-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k955235-b-d-ultra-fine-ii-micro-fine-short-fda-510k.jpg K955235 - B-D ULTRA FINE II, MICRO FINE + SHORT NEEDLE INSULIN SYRINGE K955235 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Feb 1996. https://www.510kdatabase.net/k952337/ 1996-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k952337-roche-unimate-3unimate-5-hba1c-hba1c-fda-510k.jpg K952337 - ROCHE UNIMATE 3/UNIMATE 5 HBA1C, HBA1C CALIBRATOR, HBA1C CONTROLS N & P K952337 is a FDA 510(k) cleared hematology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k952668/ 1996-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k952668-chrom-z-fviii-cat-no-5241-fda-510k.jpg K952668 - CHROM Z-F:VIII, CAT. NO. 5241 K952668 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Feb 1996. https://www.510kdatabase.net/k955396/ 1996-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k955396-stainless-steel-greenfield-vena-cava-fda-510k.jpg K955396 - STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F FLEXCARRIER INTRODUCTER SYSTEM K955396 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Feb 1996. https://www.510kdatabase.net/k955480/ 1996-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k955480-bozotta-reinsertion-forceps-fda-510k.jpg K955480 - BOZOTTA REINSERTION FORCEPS K955480 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955675/ 1996-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k955675-synchron-systems-propoxyphene-reagent-fda-510k.jpg K955675 - SYNCHRON SYSTEMS PROPOXYPHENE REAGENT K955675 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955780/ 1996-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k955780-rigidyne-a-external-fixation-system-fda-510k.jpg K955780 - RIGIDYNE A EXTERNAL FIXATION SYSTEM K955780 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955906/ 1996-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k955906-boehringer-mannheim-igg-assay-fda-510k.jpg K955906 - BOEHRINGER MANNHEIM IGG ASSAY K955906 is a FDA 510(k) cleared immunology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Feb 1996. https://www.510kdatabase.net/k955907/ 1996-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k955907-boehringer-mannheim-iga-assay-fda-510k.jpg K955907 - BOEHRINGER MANNHEIM IGA ASSAY K955907 is a FDA 510(k) cleared immunology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Feb 1996. https://www.510kdatabase.net/k955908/ 1996-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k955908-boehringer-mannheim-igm-assay-fda-510k.jpg K955908 - BOEHRINGER MANNHEIM IGM ASSAY K955908 is a FDA 510(k) cleared immunology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Feb 1996. https://www.510kdatabase.net/k950118/ 1996-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k950118-abrm-catheter-fda-510k.jpg K950118 - ABRM CATHETER K950118 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cook, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955195/ 1996-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k955195-sal-salmonella-h-q-antiserum-fda-510k.jpg K955195 - SAL SALMONELLA H Q ANTISERUM K955195 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955196/ 1996-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k955196-sas-salmonella-h-poly-e-antiserum-fda-510k.jpg K955196 - SAS SALMONELLA H POLY E ANTISERUM K955196 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955197/ 1996-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k955197-sas-salmonella-h-poly-d-antiserum-fda-510k.jpg K955197 - SAS SALMONELLA H POLY D ANTISERUM K955197 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955211/ 1996-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k955211-sas-salmonella-h-factor-6-antiserum-fda-510k.jpg K955211 - SAS SALMONELLA H FACTOR 6 ANTISERUM K955211 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955212/ 1996-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k955212-sas-salmonella-h-factor-5-antiserum-fda-510k.jpg K955212 - SAS SALMONELLA H FACTOR 5 ANTISERUM K955212 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955213/ 1996-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k955213-sas-salmonella-h-enz15-antiserum-fda-510k.jpg K955213 - SAS SALMONELLA H E,N,Z15 ANTISERUM K955213 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955214/ 1996-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k955214-sas-salmonella-enx-antiserum-fda-510k.jpg K955214 - SAS SALMONELLA E,N,X ANTISERUM K955214 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955215/ 1996-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k955215-sas-salmonella-h-e-complex-antiserum-fda-510k.jpg K955215 - SAS SALMONELLA H E COMPLEX ANTISERUM K955215 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955216/ 1996-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k955216-sas-salmonella-h-a-antiserum-fda-510k.jpg K955216 - SAS SALMONELLA H A ANTISERUM K955216 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955217/ 1996-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k955217-sas-salmonella-h-12-antiserum-fda-510k.jpg K955217 - SAS SALMONELLA H 1,2 ANTISERUM K955217 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955218/ 1996-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k955218-sas-salmonella-h-17-antiserum-fda-510k.jpg K955218 - SAS SALMONELLA H 1,7 ANTISERUM K955218 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955219/ 1996-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k955219-sas-salmonella-h-factor-7-antiserum-fda-510k.jpg K955219 - SAS SALMONELLA H FACTOR 7 ANTISERUM K955219 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955220/ 1996-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k955220-sas-salmonella-h-z36-antiserum-fda-510k.jpg K955220 - SAS SALMONELLA H Z36 ANTISERUM K955220 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955221/ 1996-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k955221-sas-salmonella-h-z38-antiserum-fda-510k.jpg K955221 - SAS SALMONELLA H Z38 ANTISERUM K955221 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k952687/ 1996-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k952687-panalok-wedge-absorable-suture-anchor-fda-510k.jpg K952687 - PANALOK WEDGE ABSORABLE SUTURE ANCHOR SYSTEM K952687 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ethicon, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955870/ 1996-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k955870-immulite-total-testosterone-fda-510k.jpg K955870 - IMMULITE TOTAL TESTOSTERONE K955870 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Feb 1996. https://www.510kdatabase.net/k943367/ 1996-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k943367-il-test-cholinesterase-fda-510k.jpg K943367 - IL TEST CHOLINESTERASE K943367 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Feb 1996. https://www.510kdatabase.net/k953968/ 1996-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k953968-aesculap-power-systems-elan-e-microtron-fda-510k.jpg K953968 - AESCULAP POWER SYSTEMS (ELAN-E & MICROTRON) K953968 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aesculap, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k954632/ 1996-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k954632-siemens-sc-9000-etco2-module-fda-510k.jpg K954632 - SIEMENS SC 9000 ETCO2 MODULE K954632 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955099/ 1996-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k955099-sorbie-total-elbow-system-fda-510k.jpg K955099 - SORBIE TOTAL ELBOW SYSTEM K955099 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Feb 1996. https://www.510kdatabase.net/k955153/ 1996-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k955153-lyphochek-benzotca-control-set-b-fda-510k.jpg K955153 - LYPHOCHEK BENZO/TCA CONTROL-SET B K955153 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bio-Rad. Cleared Feb 1996. https://www.510kdatabase.net/k955186/ 1996-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k955186-sas-salmonella-h-z29-antiserum-fda-510k.jpg K955186 - SAS SALMONELLA H Z29 ANTISERUM K955186 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955187/ 1996-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k955187-sas-salmonella-h-z4-z23-antiserum-fda-510k.jpg K955187 - SAS SALMONELLA H Z4, Z23 ANTISERUM K955187 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955188/ 1996-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k955188-sas-salmonella-h-z6-antiserum-fda-510k.jpg K955188 - SAS SALMONELLA H Z6 ANTISERUM K955188 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955189/ 1996-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k955189-sas-salmonella-h-z-antiserum-fda-510k.jpg K955189 - SAS SALMONELLA H Z ANTISERUM K955189 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955190/ 1996-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k955190-sas-salmonella-h-y-antiserum-fda-510k.jpg K955190 - SAS SALMONELLA H Y ANTISERUM K955190 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955191/ 1996-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k955191-sas-salmonella-h-x-antiserum-fda-510k.jpg K955191 - SAS SALMONELLA H X ANTISERUM K955191 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955192/ 1996-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k955192-sas-salmonella-h-t-antiserum-fda-510k.jpg K955192 - SAS SALMONELLA H T ANTISERUM K955192 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955193/ 1996-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k955193-sas-salmonella-h-s-antiserum-fda-510k.jpg K955193 - SAS SALMONELLA H S ANTISERUM K955193 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955194/ 1996-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k955194-sas-salmonella-h-r-antiserum-fda-510k.jpg K955194 - SAS SALMONELLA H R ANTISERUM K955194 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955198/ 1996-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k955198-sas-salmonella-h-poly-c-antiserum-fda-510k.jpg K955198 - SAS SALMONELLA H POLY C ANTISERUM K955198 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955199/ 1996-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k955199-sas-salmonella-h-poly-b-antiserum-fda-510k.jpg K955199 - SAS SALMONELLA H POLY B ANTISERUM K955199 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955200/ 1996-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k955200-sas-salmonella-h-poly-a-antiserum-fda-510k.jpg K955200 - SAS SALMONELLA H POLY A ANTISERUM K955200 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955201/ 1996-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k955201-sas-salmonella-hmt-antiserum-fda-510k.jpg K955201 - SAS SALMONELLA H,M,T, ANTISERUM K955201 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955202/ 1996-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k955202-sas-salmonella-h-lz40-antiserum-fda-510k.jpg K955202 - SAS SALMONELLA H L,Z40 ANTISERUM K955202 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955203/ 1996-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k955203-sas-salmonella-h-lz13-antiserum-fda-510k.jpg K955203 - SAS SALMONELLA H L,Z13 ANTISERUM K955203 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955204/ 1996-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k955204-sas-salmonella-h-lw-antiserum-fda-510k.jpg K955204 - SAS SALMONELLA H L,W ANTISERUM K955204 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955205/ 1996-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k955205-sas-salmonella-h-lv-antiserum-fda-510k.jpg K955205 - SAS SALMONELLA H L,V ANTISERUM K955205 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955206/ 1996-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k955206-sas-salmonella-h-k-antiserum-fda-510k.jpg K955206 - SAS SALMONELLA H K ANTISERUM K955206 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955207/ 1996-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k955207-sas-salmonella-h-i-antiserum-fda-510k.jpg K955207 - SAS SALMONELLA H I ANTISERUM K955207 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955208/ 1996-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k955208-sas-salmonella-h-h-antiserum-fda-510k.jpg K955208 - SAS SALMONELLA H H ANTISERUM K955208 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955209/ 1996-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k955209-sas-salmonella-h-gm-antiserum-fda-510k.jpg K955209 - SAS SALMONELLA H G,M ANTISERUM K955209 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955210/ 1996-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k955210-sas-salmonella-h-fg-antiserum-fda-510k.jpg K955210 - SAS SALMONELLA H F,G, ANTISERUM K955210 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955801/ 1996-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k955801-radifocus-glidewire-gt-with-gold-fda-510k.jpg K955801 - RADIFOCUS GLIDEWIRE GT WITH GOLD COIL,GLIDEWIRE GOLD K955801 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Feb 1996. https://www.510kdatabase.net/k953694/ 1996-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k953694-depuy-vision-aml-hip-prothesis-fda-510k.jpg K953694 - DEPUY VISION AML HIP PROTHESIS K953694 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k953703/ 1996-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k953703-depuy-vision-solution-hip-prosthesis-fda-510k.jpg K953703 - DEPUY VISION SOLUTION HIP PROSTHESIS K953703 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955364/ 1996-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k955364-seamguard-staple-line-reinforcement-fda-510k.jpg K955364 - SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL K955364 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k955404/ 1996-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k955404-otv-s5-oes-video-system-fda-510k.jpg K955404 - OTV-S5 OES VIDEO SYSTEM K955404 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Olympus America, Inc.. Cleared Feb 1996. https://www.510kdatabase.net/k945938/ 1996-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k945938-respironics-monarch-mini-mask-fda-510k.jpg K945938 - RESPIRONICS MONARCH MINI MASK K945938 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Jan 1996. https://www.510kdatabase.net/k952859/ 1996-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k952859-ultima-cemented-long-stem-femoral-fda-510k.jpg K952859 - ULTIMA CEMENTED LONG STEM FEMORAL COMPONENT K952859 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jan 1996. https://www.510kdatabase.net/k953200/ 1996-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k953200-ultima-size-0-cemented-femoral-stem-fda-510k.jpg K953200 - ULTIMA SIZE 0 CEMENTED FEMORAL STEM K953200 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jan 1996. https://www.510kdatabase.net/k953202/ 1996-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k953202-pfc-size-0-cemented-femoral-component-fda-510k.jpg K953202 - P.F.C. SIZE 0 CEMENTED FEMORAL COMPONENT K953202 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jan 1996. https://www.510kdatabase.net/k953925/ 1996-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k953925-fine-grain-cast-cobalt-chromium-hip-fda-510k.jpg K953925 - FINE GRAIN CAST COBALT CHROMIUM HIP STEMS K953925 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jan 1996. https://www.510kdatabase.net/k954207/ 1996-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k954207-gel-mask-fda-510k.jpg K954207 - GEL MASK K954207 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Jan 1996. https://www.510kdatabase.net/k955752/ 1996-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k955752-olympus-uric-acid-reagent-fda-510k.jpg K955752 - OLYMPUS URIC ACID REAGENT K955752 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus America, Inc.. Cleared Jan 1996. https://www.510kdatabase.net/k952666/ 1996-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k952666-chrom-z-protein-c-cat-no-5243-fda-510k.jpg K952666 - CHROM Z-PROTEIN C, CAT. NO. 5243 K952666 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Jan 1996. https://www.510kdatabase.net/k953341/ 1996-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k953341-aria-cpap-system-fda-510k.jpg K953341 - ARIA CPAP SYSTEM K953341 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Jan 1996. https://www.510kdatabase.net/k953439/ 1996-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k953439-ultrack-total-knee-system-fda-510k.jpg K953439 - ULTRACK TOTAL KNEE SYSTEM K953439 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jan 1996. https://www.510kdatabase.net/k955116/ 1996-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k955116-benzodiazepines-by-remedi-hs-fda-510k.jpg K955116 - BENZODIAZEPINES BY REMEDI HS K955116 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bio-Rad. Cleared Jan 1996. https://www.510kdatabase.net/k955268/ 1996-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k955268-pq-2000-computed-tomography-x-ray-system-fda-510k.jpg K955268 - PQ-2000+ COMPUTED TOMOGRAPHY X-RAY SYSTEM K955268 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Jan 1996. https://www.510kdatabase.net/k955385/ 1996-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k955385-johnson-johnson-austin-moore-stem-fda-510k.jpg K955385 - JOHNSON & JOHNSON AUSTIN MOORE STEM K955385 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jan 1996. https://www.510kdatabase.net/k943366/ 1996-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k943366-il-test-acid-phosphatase-fda-510k.jpg K943366 - IL TEST ACID PHOSPHATASE K943366 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jan 1996. https://www.510kdatabase.net/k955434/ 1996-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k955434-access-folate-assay-modification-fda-510k.jpg K955434 - ACCESS FOLATE ASSAY (MODIFICATION) K955434 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Jan 1996. https://www.510kdatabase.net/k944544/ 1996-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k944544-absorbable-bone-screw-fda-510k.jpg K944544 - ABSORBABLE BONE SCREW K944544 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jan 1996. https://www.510kdatabase.net/k952819/ 1996-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k952819-abbott-testpack-plus-strep-a-with-on-fda-510k.jpg K952819 - ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) K952819 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Jan 1996. https://www.510kdatabase.net/k953250/ 1996-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k953250-senographe-pearl-and-senographe-sapphire-fda-510k.jpg K953250 - SENOGRAPHE PEARL AND SENOGRAPHE SAPPHIRE K953250 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Jan 1996. https://www.510kdatabase.net/k954555/ 1996-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k954555-versa-fx-femoral-fixation-system-fda-510k.jpg K954555 - VERSA-FX FEMORAL FIXATION SYSTEM K954555 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jan 1996. https://www.510kdatabase.net/k954684/ 1996-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k954684-depuy-anatomic-modular-knee-amk-fda-510k.jpg K954684 - DEPUY ANATOMIC MODULAR KNEE (AMK) CONGRUENCY POSTERIOR STABILIZED TIBIAL INSERT K954684 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jan 1996. https://www.510kdatabase.net/k945303/ 1996-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k945303-arthrex-bioabsorbable-interference-screw-fda-510k.jpg K945303 - ARTHREX BIOABSORBABLE INTERFERENCE SCREW K945303 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jan 1996. https://www.510kdatabase.net/k954992/ 1996-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k954992-roche-cobas-integra-reagent-cassettes-fda-510k.jpg K954992 - ROCHE COBAS INTEGRA REAGENT CASSETTES K954992 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jan 1996. https://www.510kdatabase.net/k955066/ 1996-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k955066-olympus-fg-series-grasping-forceps-fda-510k.jpg K955066 - OLYMPUS FG SERIES GRASPING FORCEPS K955066 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus America, Inc.. Cleared Jan 1996. https://www.510kdatabase.net/k955284/ 1996-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k955284-opus-troponin-i-fda-510k.jpg K955284 - OPUS TROPONIN I K955284 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Jan 1996. https://www.510kdatabase.net/k952557/ 1996-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k952557-total-t-3-fpia-reagent-set-total-t-3-fda-510k.jpg K952557 - TOTAL T-3 FPIA REAGENT SET, TOTAL T-3 FPIA CALIBRATORS K952557 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Jan 1996. https://www.510kdatabase.net/k955052/ 1996-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k955052-olympus-fd-12-1-hot-biopsy-forceps-fda-510k.jpg K955052 - OLYMPUS FD-1/2-1 HOT BIOPSY FORCEPS K955052 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus America, Inc.. Cleared Jan 1996. https://www.510kdatabase.net/k955065/ 1996-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k955065-olympus-fb-series-biopsy-forceps-fda-510k.jpg K955065 - OLYMPUS FB SERIES BIOPSY FORCEPS K955065 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus America, Inc.. Cleared Jan 1996. https://www.510kdatabase.net/k955354/ 1996-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k955354-alternative-sterilization-process-fda-510k.jpg K955354 - ALTERNATIVE STERILIZATION PROCESS K955354 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jan 1996. https://www.510kdatabase.net/k955494/ 1996-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k955494-gore-tex-dualmesh-biomaterial-with-holes-fda-510k.jpg K955494 - GORE-TEX DUALMESH BIOMATERIAL WITH HOLES K955494 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Jan 1996. https://www.510kdatabase.net/k954744/ 1996-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k954744-zch-alpha-system-fda-510k.jpg K954744 - ZCH ALPHA SYSTEM K954744 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jan 1996. https://www.510kdatabase.net/k953337/ 1996-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k953337-beta-hip-prosthesis-fda-510k.jpg K953337 - BETA HIP PROSTHESIS K953337 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jan 1996. https://www.510kdatabase.net/k955063/ 1996-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k955063-olympus-basket-graspers-fda-510k.jpg K955063 - OLYMPUS BASKET GRASPERS K955063 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus America, Inc.. Cleared Jan 1996. https://www.510kdatabase.net/k955098/ 1996-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k955098-3m-mini-driver-electric-system-fda-510k.jpg K955098 - 3M MINI-DRIVER ELECTRIC SYSTEM K955098 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 3M Company. Cleared Jan 1996. https://www.510kdatabase.net/k954525/ 1996-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k954525-sensi-touch-epidural-anesthesia-filter-fda-510k.jpg K954525 - SENSI-TOUCH EPIDURAL ANESTHESIA FILTER K954525 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sherwood Medical Co.. Cleared Jan 1996. https://www.510kdatabase.net/k950272/ 1996-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k950272-panalok-absorbable-suture-anchor-system-fda-510k.jpg K950272 - PANALOK ABSORBABLE SUTURE ANCHOR SYSTEM K950272 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ethicon, Inc.. Cleared Jan 1996. https://www.510kdatabase.net/k952799/ 1996-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k952799-abbott-xl3m-infusion-pump-fda-510k.jpg K952799 - ABBOTT XL3M INFUSION PUMP K952799 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Jan 1996. https://www.510kdatabase.net/k952830/ 1996-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k952830-darwin-knee-system-tc3-fda-510k.jpg K952830 - DARWIN KNEE SYSTEM (TC3) K952830 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jan 1996. https://www.510kdatabase.net/k954646/ 1996-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k954646-epi-ii-system-option-whigh-performance-fda-510k.jpg K954646 - EPI-II SYSTEM OPTION W/HIGH PERFORMANCE GRADIENTS K954646 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Jan 1996. https://www.510kdatabase.net/k955051/ 1996-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k955051-olympus-fg-series-of-rat-tooth-fda-510k.jpg K955051 - OLYMPUS FG SERIES OF RAT TOOTH GRASPING FORCEPS K955051 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus America, Inc.. Cleared Jan 1996. https://www.510kdatabase.net/k955229/ 1996-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k955229-wright-medical-technology-sawblades-fda-510k.jpg K955229 - WRIGHT MEDICAL TECHNOLOGY SAWBLADES K955229 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jan 1996. https://www.510kdatabase.net/k955305/ 1996-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k955305-pca-15mm-modular-femoral-head-fda-510k.jpg K955305 - PCA +15MM MODULAR FEMORAL HEAD K955305 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jan 1996. https://www.510kdatabase.net/k951517/ 1996-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k951517-osteonics-secur-fit-ha-plus-hip-stem-fda-510k.jpg K951517 - OSTEONICS SECUR-FIT HA PLUS HIP STEM SERIES K951517 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Jan 1996. https://www.510kdatabase.net/k952970/ 1996-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k952970-howmedica-femoral-proximal-tibial-fda-510k.jpg K952970 - HOWMEDICA FEMORAL & PROXIMAL TIBIAL MODULAR REPLACEMENT SYTESM K952970 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jan 1996. https://www.510kdatabase.net/k954698/ 1996-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k954698-trilogy-acetabular-component-7mm-offset-fda-510k.jpg K954698 - TRILOGY ACETABULAR COMPONENT 7MM OFFSET K954698 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jan 1996. https://www.510kdatabase.net/k954797/ 1996-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k954797-karl-storz-rhino-laryngo-broncho-fda-510k.jpg K954797 - KARL STORZ RHINO-LARYNGO-BRONCHO FIBERSCOPE, FIBERSCOPE FOR BRONCHOSCOPY K954797 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jan 1996. https://www.510kdatabase.net/k954811/ 1996-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k954811-depuy-advantage-hip-femoral-prosthesis-fda-510k.jpg K954811 - DEPUY ADVANTAGE HIP FEMORAL PROSTHESIS WITH POROCOAT K954811 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jan 1996. https://www.510kdatabase.net/k955652/ 1996-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k955652-karl-storz-targeting-unit-fda-510k.jpg K955652 - KARL STORZ TARGETING UNIT K955652 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jan 1996. https://www.510kdatabase.net/k952572/ 1996-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k952572-dialysis-administration-kits-fda-510k.jpg K952572 - DIALYSIS ADMINISTRATION KITS K952572 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Jan 1996. https://www.510kdatabase.net/k954431/ 1996-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k954431-percutaneous-intra-aortic-balloon-fda-510k.jpg K954431 - PERCUTANEOUS INTRA-AORTIC BALLOON CATHETERS K954431 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Jan 1996. https://www.510kdatabase.net/k954667/ 1996-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k954667-monotube-tube-to-tube-clamp-fda-510k.jpg K954667 - MONOTUBE TUBE-TO-TUBE CLAMP K954667 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jan 1996. https://www.510kdatabase.net/k953077/ 1996-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k953077-paragon-cze-2000-clinical-capillary-fda-510k.jpg K953077 - PARAGON CZE 2000 CLINICAL CAPILLARY ELECTROPHORESIS SYSTEM K953077 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jan 1996. https://www.510kdatabase.net/k954248/ 1996-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k954248-siemens-virtural-wedge-fda-510k.jpg K954248 - SIEMENS VIRTURAL WEDGE K954248 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 1996. https://www.510kdatabase.net/k954839/ 1996-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k954839-aspartate-aminotransferase-procedure-fda-510k.jpg K954839 - ASPARTATE AMINOTRANSFERASE PROCEDURE NO.. 58-UV K954839 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Jan 1996. https://www.510kdatabase.net/k951978/ 1996-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k951978-hewlett-packard-model-m1791a-acute-fda-510k.jpg K951978 - HEWLETT-PACKARD MODEL M1791A ACUTE CARDIAC ISCHEMIA-TIME INSENSITIVE PREDICITIVE INSTRUMENT (ACI-TIPT) K951978 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Jan 1996. https://www.510kdatabase.net/k955185/ 1996-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k955185-ge-advantage-dicom-cr-reprocessing-fda-510k.jpg K955185 - GE ADVANTAGE DICOM CR REPROCESSING STATION K955185 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Jan 1996. https://www.510kdatabase.net/k954420/ 1995-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k954420-axsym-digitoxin-fda-510k.jpg K954420 - AXSYM DIGITOXIN K954420 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Dec 1995. https://www.510kdatabase.net/k954529/ 1995-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k954529-automated-tru-cut-biopsy-device-fda-510k.jpg K954529 - AUTOMATED TRU-CUT BIOPSY DEVICE K954529 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Dec 1995. https://www.510kdatabase.net/k945774/ 1995-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k945774-beta-femoral-hip-stem-fda-510k.jpg K945774 - BETA FEMORAL HIP STEM K945774 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Dec 1995. https://www.510kdatabase.net/k954595/ 1995-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k954595-cordis-brite-tip-sheath-introducer-fda-510k.jpg K954595 - CORDIS BRITE TIP SHEATH INTRODUCER K954595 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Dec 1995. https://www.510kdatabase.net/k954915/ 1995-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k954915-flexible-intramedullary-reamer-fda-510k.jpg K954915 - FLEXIBLE INTRAMEDULLARY REAMER K954915 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Dec 1995. https://www.510kdatabase.net/k954608/ 1995-12-26 monthly 0.5 https://www.510kdatabase.net/og-image/k954608-cedia-dau-multi-dr-calibratorpri-sec-fda-510k.jpg K954608 - CEDIA DAU MULTI-DR CALIBRATOR/PRI, SEC, INTER, HIGH K954608 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Dec 1995. https://www.510kdatabase.net/k941352/ 1995-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k941352-ssa-340a-fda-510k.jpg K941352 - SSA-340A K941352 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Dec 1995. https://www.510kdatabase.net/k943896/ 1995-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k943896-guide-wire-for-the-use-with-datascope-fda-510k.jpg K943896 - GUIDE WIRE FOR THE USE WITH DATASCOPE PERCOR STAT-DL IABS K943896 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Dec 1995. https://www.510kdatabase.net/k953098/ 1995-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k953098-volumetric-infusion-pump-fda-510k.jpg K953098 - VOLUMETRIC INFUSION PUMP K953098 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Dec 1995. https://www.510kdatabase.net/k954655/ 1995-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k954655-roche-control-serum-n-fda-510k.jpg K954655 - ROCHE CONTROL SERUM N K954655 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Dec 1995. https://www.510kdatabase.net/k954656/ 1995-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k954656-roche-control-serum-p-fda-510k.jpg K954656 - ROCHE CONTROL SERUM P K954656 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Dec 1995. https://www.510kdatabase.net/k954807/ 1995-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k954807-cedia-t-uptake-assay-fda-510k.jpg K954807 - CEDIA T UPTAKE ASSAY K954807 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Dec 1995. https://www.510kdatabase.net/k955440/ 1995-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k955440-immulite-shbg-modification-fda-510k.jpg K955440 - IMMULITE SHBG (MODIFICATION) K955440 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Dec 1995. https://www.510kdatabase.net/k943304/ 1995-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k943304-3d-surgical-endoscopy-system-for-urology-fda-510k.jpg K943304 - 3D SURGICAL ENDOSCOPY SYSTEM FOR UROLOGY K943304 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus America, Inc.. Cleared Dec 1995. https://www.510kdatabase.net/k943307/ 1995-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k943307-3d-surgical-endoscopy-system-for-fda-510k.jpg K943307 - 3D SURGICAL ENDOSCOPY SYSTEM FOR GENERAL SURGERY K943307 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Olympus America, Inc.. Cleared Dec 1995. https://www.510kdatabase.net/k953569/ 1995-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k953569-courier-balloon-dilatation-catheter-fda-510k.jpg K953569 - COURIER BALLOON DILATATION CATHETER K953569 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Dec 1995. https://www.510kdatabase.net/k954853/ 1995-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k954853-auto-suture-suture-closure-fda-510k.jpg K954853 - AUTO SUTURE SUTURE CLOSURE K954853 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Dec 1995. https://www.510kdatabase.net/k953162/ 1995-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k953162-olympus-high-flow-insufflation-unit-fda-510k.jpg K953162 - OLYMPUS HIGH FLOW INSUFFLATION UNIT K953162 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Olympus America, Inc.. Cleared Dec 1995. https://www.510kdatabase.net/k954566/ 1995-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k954566-specific-allergen-modules-for-the-fda-510k.jpg K954566 - SPECIFIC ALLERGEN MODULES FOR THE ALASTAT MICROPLATE ALLERGEN-SPECIFIC IGE SYSTEM K954566 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Dec 1995. https://www.510kdatabase.net/k950201/ 1995-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k950201-argyler-hydrophilic-coated-thoracic-fda-510k.jpg K950201 - ARGYLE(R) HYDROPHILIC COATED THORACIC CATHETER K950201 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Dec 1995. https://www.510kdatabase.net/k953866/ 1995-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k953866-minix-834m-minix-st-8331m-pulse-fda-510k.jpg K953866 - MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION) K953866 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Dec 1995. https://www.510kdatabase.net/k954092/ 1995-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k954092-alternate-sterlization-process-fda-510k.jpg K954092 - ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION) K954092 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Dec 1995. https://www.510kdatabase.net/k955049/ 1995-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k955049-olympus-fg-4546-1-grasping-forceps-fda-510k.jpg K955049 - OLYMPUS FG-45/46-1 GRASPING FORCEPS K955049 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus America, Inc.. Cleared Dec 1995. https://www.510kdatabase.net/k953731/ 1995-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k953731-pancretec-provider-apm-infusion-pump-fda-510k.jpg K953731 - PANCRETEC PROVIDER APM INFUSION PUMP (MODIFICATION) K953731 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Dec 1995. https://www.510kdatabase.net/k954300/ 1995-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k954300-argyle-neo-sert-hydrophilic-fda-510k.jpg K954300 - ARGYLE NEO-SERT HYDROPHILIC POLYURETHANE UMBILICAL VESSEL CATHETER INSERTION TRAY K954300 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Dec 1995. https://www.510kdatabase.net/k954554/ 1995-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k954554-alta-tibialhumeral-rod-fda-510k.jpg K954554 - ALTA TIBIAL/HUMERAL ROD K954554 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Dec 1995. https://www.510kdatabase.net/k954630/ 1995-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k954630-depuy-titanium-cross-pin-fixation-system-fda-510k.jpg K954630 - DEPUY TITANIUM CROSS PIN FIXATION SYSTEM K954630 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Dec 1995. https://www.510kdatabase.net/k954799/ 1995-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k954799-ontraj-testcup-collectionurinalysis-fda-510k.jpg K954799 - ONTRAJ TESTCUP COLLECTION/URINALYSIS PANEL K954799 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Dec 1995. https://www.510kdatabase.net/k954809/ 1995-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k954809-unipolar-temporary-myocardial-pacing-fda-510k.jpg K954809 - UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE MODEL 6494 K954809 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Dec 1995. https://www.510kdatabase.net/k944612/ 1995-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k944612-acustar-i-advanced-surgical-navigation-fda-510k.jpg K944612 - ACUSTAR I ADVANCED SURGICAL NAVIGATION SYSTEM K944612 is a FDA 510(k) cleared radiology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Dec 1995. https://www.510kdatabase.net/k946249/ 1995-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k946249-bardr-jejunal-feedinggastric-fda-510k.jpg K946249 - BARD(R) JEJUNAL FEEDING/GASTRIC DECOMPRESSION TUBES K946249 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 1995. https://www.510kdatabase.net/k954417/ 1995-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k954417-a-b-acetabular-component-fda-510k.jpg K954417 - A-B ACETABULAR COMPONENT K954417 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Dec 1995. https://www.510kdatabase.net/k934622/ 1995-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k934622-lcx-chlamydia-trachomatis-assay-fda-510k.jpg K934622 - LCX CHLAMYDIA TRACHOMATIS ASSAY K934622 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Dec 1995. https://www.510kdatabase.net/k952938/ 1995-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k952938-aquaflo-btp-hydrogel-wound-dressing-fda-510k.jpg K952938 - AQUAFLO BTP HYDROGEL WOUND DRESSING K952938 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sherwood Medical Co.. Cleared Dec 1995. https://www.510kdatabase.net/k955479/ 1995-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k955479-koh-micro-suturing-instruments-fda-510k.jpg K955479 - KOH MICRO-SUTURING INSTRUMENTS K955479 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Dec 1995. https://www.510kdatabase.net/k952669/ 1995-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k952669-chrom-z-plasminogen-cat-no-5244-fda-510k.jpg K952669 - CHROM Z-PLASMINOGEN, CAT. NO. 5244 K952669 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Dec 1995. https://www.510kdatabase.net/k954582/ 1995-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k954582-bard-expanded-ptfe-vascular-fda-510k.jpg K954582 - BARD EXPANDED PTFE VASCULAR GRAFT(MODIFICATION) K954582 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 1995. https://www.510kdatabase.net/k954699/ 1995-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k954699-bray-rongeur-fda-510k.jpg K954699 - BRAY RONGEUR K954699 is a FDA 510(k) cleared neurology medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Dec 1995. https://www.510kdatabase.net/k954981/ 1995-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k954981-karl-storz-hempfling-dilation-set-fda-510k.jpg K954981 - KARL STORZ HEMPFLING DILATION SET K954981 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Dec 1995. https://www.510kdatabase.net/k955272/ 1995-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k955272-take-apart-arthro-scissors-gasping-fda-510k.jpg K955272 - TAKE-APART ARTHRO-SCISSORS, GASPING, BIOPSY PUNCH FORCEPS FOR ARTHROSCOPY K955272 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Dec 1995. https://www.510kdatabase.net/k954297/ 1995-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k954297-celsite-venous-access-system-otw-fda-510k.jpg K954297 - CELSITE VENOUS ACCESS SYSTEM OTW K954297 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Dec 1995. https://www.510kdatabase.net/k953790/ 1995-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k953790-bd-perisafe-epidural-anesthesia-tray-fda-510k.jpg K953790 - BD PERISAFE EPIDURAL ANESTHESIA TRAY K953790 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Nov 1995. https://www.510kdatabase.net/k954288/ 1995-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k954288-extend-hip-system-fda-510k.jpg K954288 - EXTEND HIP SYSTEM K954288 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Nov 1995. https://www.510kdatabase.net/k954534/ 1995-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k954534-osteonics-unipolar-endo-head-fda-510k.jpg K954534 - OSTEONICS UNIPOLAR ENDO HEAD K954534 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Nov 1995. https://www.510kdatabase.net/k953961/ 1995-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k953961-osteonics-insight-knee-positioning-fda-510k.jpg K953961 - OSTEONICS INSIGHT KNEE POSITIONING & ALIGNMENT SYSTEM K953961 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Osteonics Corp.. Cleared Nov 1995. https://www.510kdatabase.net/k954755/ 1995-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k954755-coat-a-count-direct-androstenedione-fda-510k.jpg K954755 - COAT-A-COUNT DIRECT ANDROSTENEDIONE K954755 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Nov 1995. https://www.510kdatabase.net/k955024/ 1995-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k955024-liquichek-ethanolammonia-control-fda-510k.jpg K955024 - LIQUICHEK ETHANOL/AMMONIA CONTROL K955024 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Nov 1995. https://www.510kdatabase.net/k945944/ 1995-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k945944-nihon-kohden-wep-8430a-central-fda-510k.jpg K945944 - NIHON KOHDEN WEP-8430A CENTRAL TELEMETRY SYSTEM K945944 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Nov 1995. https://www.510kdatabase.net/k951566/ 1995-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k951566-swan-ganze-continuous-cardiac-fda-510k.jpg K951566 - SWAN-GANZE CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS INFUSION PORT/EJECTION FRACTION/VOLUMETRIC (CCO/SVO2/VIP/REF) CATH] K951566 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Nov 1995. https://www.510kdatabase.net/k954234/ 1995-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k954234-radifocus-introducer-ii-kit-fda-510k.jpg K954234 - RADIFOCUS INTRODUCER II KIT K954234 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Nov 1995. https://www.510kdatabase.net/k954886/ 1995-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k954886-model-nos-7495-and-501826-extensions-fda-510k.jpg K954886 - MODEL NOS. 7495 AND 501826 EXTENSIONS K954886 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Nov 1995. https://www.510kdatabase.net/k954929/ 1995-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k954929-charisma-single-dose-fda-510k.jpg K954929 - CHARISMA SINGLE DOSE K954929 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Nov 1995. https://www.510kdatabase.net/k942604/ 1995-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k942604-signa-advantage-sp-magnetic-resonance-fda-510k.jpg K942604 - SIGNA ADVANTAGE SP MAGNETIC RESONANCE SYSTEM K942604 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Nov 1995. https://www.510kdatabase.net/k954289/ 1995-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k954289-synthes-cannulated-angle-blade-plate-fda-510k.jpg K954289 - SYNTHES CANNULATED ANGLE BLADE PLATE K954289 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Nov 1995. https://www.510kdatabase.net/k954666/ 1995-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k954666-mph50-mph65-and-mph80-fda-510k.jpg K954666 - MPH50, MPH65, AND MPH80 K954666 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Nov 1995. https://www.510kdatabase.net/k944473/ 1995-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k944473-xchf-33-choledochofiberscope-fda-510k.jpg K944473 - XCHF-33 CHOLEDOCHOFIBERSCOPE K944473 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus America, Inc.. Cleared Nov 1995. https://www.510kdatabase.net/k946175/ 1995-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k946175-nihon-kohden-zb-831pa-telemetry-fda-510k.jpg K946175 - NIHON KOHDEN ZB-831PA TELEMETRY TRANSMITTER K946175 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Nov 1995. https://www.510kdatabase.net/k951139/ 1995-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k951139-alpha-long-stem-femoral-component-fda-510k.jpg K951139 - ALPHA LONG STEM FEMORAL COMPONENT (SUBJECT TO WMTI MARKETING APPROVAL) K951139 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Nov 1995. https://www.510kdatabase.net/k953761/ 1995-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k953761-axsym-tricyclic-antidepressants-fda-510k.jpg K953761 - AXSYM TRICYCLIC ANTIDEPRESSANTS K953761 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1995. https://www.510kdatabase.net/k953771/ 1995-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k953771-operating-laryngoscopes-accessories-fda-510k.jpg K953771 - OPERATING LARYNGOSCOPES & ACCESSORIES FORCEPS, PROTECTORS K953771 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Nov 1995. https://www.510kdatabase.net/k954023/ 1995-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k954023-osteonics-secur-fit-ha-psl-extra-fda-510k.jpg K954023 - OSTEONICS SECUR-FIT HA PSL EXTRA ACETABULAR COMPONENT SYSTEM K954023 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Nov 1995. https://www.510kdatabase.net/k954050/ 1995-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k954050-resectoscopes-fda-510k.jpg K954050 - RESECTOSCOPES K954050 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Nov 1995. https://www.510kdatabase.net/k954090/ 1995-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k954090-auto-suture-sterilization-tray-fda-510k.jpg K954090 - AUTO SUTURE* STERILIZATION TRAY** K954090 is a FDA 510(k) cleared general hospital medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Nov 1995. https://www.510kdatabase.net/k954668/ 1995-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k954668-hp-echo-image-management-system-fda-510k.jpg K954668 - HP ECHO IMAGE MANAGEMENT SYSTEM K954668 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Nov 1995. https://www.510kdatabase.net/k945072/ 1995-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k945072-siemens-q4000-fda-510k.jpg K945072 - SIEMENS Q4000 K945072 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 1995. https://www.510kdatabase.net/k952625/ 1995-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k952625-coaguchek-system-fda-510k.jpg K952625 - COAGUCHEK SYSTEM K952625 is a FDA 510(k) cleared hematology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Nov 1995. https://www.510kdatabase.net/k952875/ 1995-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k952875-accu-chek-alpha-monitor-accu-chek-fda-510k.jpg K952875 - ACCU-CHEK ALPHA MONITOR & ACCU-CHEK GLUCOSE TEST STRIPS K952875 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Nov 1995. https://www.510kdatabase.net/k954064/ 1995-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k954064-becton-dickinson-syringse-fda-510k.jpg K954064 - BECTON DICKINSON SYRINGSE K954064 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Nov 1995. https://www.510kdatabase.net/k954104/ 1995-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k954104-per-q-cath-per-q-cath-dual-mumen-fda-510k.jpg K954104 - PER-Q-CATH & PER-Q-CATH DUAL MUMEN CATHETERS, TRAYS & ACCESSORY DEVICES K954104 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 1995. https://www.510kdatabase.net/k954123/ 1995-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k954123-low-profile-safsite-y-site-fda-510k.jpg K954123 - LOW PROFILE SAFSITE Y-SITE K954123 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Nov 1995. https://www.510kdatabase.net/k954138/ 1995-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k954138-duracon-monolithic-stabilizer-femoral-fda-510k.jpg K954138 - DURACON MONOLITHIC STABILIZER FEMORAL COMPONENT K954138 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Nov 1995. https://www.510kdatabase.net/k953714/ 1995-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k953714-zimmer-reconstruction-system-fda-510k.jpg K953714 - ZIMMER RECONSTRUCTION SYSTEM SYMPHYSEAL BONE PLATE K953714 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Nov 1995. https://www.510kdatabase.net/k954048/ 1995-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k954048-variant-hemoglobinopathy-program-fda-510k.jpg K954048 - VARIANT HEMOGLOBINOPATHY PROGRAM K954048 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bio-Rad. Cleared Nov 1995. https://www.510kdatabase.net/k954291/ 1995-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k954291-opus-tdm-controls-fda-510k.jpg K954291 - OPUS TDM CONTROLS K954291 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Nov 1995. https://www.510kdatabase.net/k954590/ 1995-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k954590-max-1000ar1-fda-510k.jpg K954590 - MAX-1000A/R1 K954590 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Nov 1995. https://www.510kdatabase.net/k943305/ 1995-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k943305-olympus-3d-surgical-endoscopy-system-fda-510k.jpg K943305 - OLYMPUS 3D SURGICAL ENDOSCOPY SYSTEM K943305 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Olympus America, Inc.. Cleared Nov 1995. https://www.510kdatabase.net/k935716/ 1995-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k935716-karl-storz-fixed-magnification-fda-510k.jpg K935716 - KARL STORZ FIXED MAGNIFICATION TELESCOPE/KS VARIABLE MAGNIFICATION TELESCOPE K935716 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Nov 1995. https://www.510kdatabase.net/k954077/ 1995-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k954077-unitrax-v40-modular-adaptor-fda-510k.jpg K954077 - UNITRAX V40 MODULAR ADAPTOR K954077 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Nov 1995. https://www.510kdatabase.net/k954348/ 1995-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k954348-glanz-carcinoma-gauge-ksea-fda-510k.jpg K954348 - GLANZ CARCINOMA GAUGE, KSEA K954348 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Nov 1995. https://www.510kdatabase.net/k945578/ 1995-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k945578-nihon-kohden-zb-821-telemetry-fda-510k.jpg K945578 - NIHON KOHDEN ZB-821 TELEMETRY TRANSMITTER K945578 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Nov 1995. https://www.510kdatabase.net/k951650/ 1995-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k951650-clinical-proton-spectroscopy-option-fda-510k.jpg K951650 - CLINICAL PROTON SPECTROSCOPY OPTION K951650 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 1995. https://www.510kdatabase.net/k951723/ 1995-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k951723-ge-b510-transducer-fda-510k.jpg K951723 - GE B510 TRANSDUCER K951723 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Nov 1995. https://www.510kdatabase.net/k952063/ 1995-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k952063-xxl-ballon-dilatation-catheter-fda-510k.jpg K952063 - XXL BALLON DILATATION CATHETER K952063 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Nov 1995. https://www.510kdatabase.net/k952898/ 1995-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k952898-gore-tex-sam-facial-implant-with-fda-510k.jpg K952898 - GORE-TEX SAM FACIAL IMPLANT WITH INTRODUCER K952898 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Nov 1995. https://www.510kdatabase.net/k954355/ 1995-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k954355-advantage-windows-3d-with-navigator-fda-510k.jpg K954355 - ADVANTAGE WINDOWS 3D WITH NAVIGATOR OPTION K954355 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Nov 1995. https://www.510kdatabase.net/k954851/ 1995-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k954851-biopolar-forceps-line-fda-510k.jpg K954851 - BIOPOLAR FORCEPS LINE K954851 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Nov 1995. https://www.510kdatabase.net/k951830/ 1995-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k951830-advantage-sim-fda-510k.jpg K951830 - ADVANTAGE SIM K951830 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Nov 1995. https://www.510kdatabase.net/k951943/ 1995-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k951943-chrom-z-chromogenic-assays-fda-510k.jpg K951943 - CHROM Z CHROMOGENIC ASSAYS K951943 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Nov 1995. https://www.510kdatabase.net/k953499/ 1995-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k953499-axsym-methadone-fda-510k.jpg K953499 - AXSYM METHADONE K953499 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1995. https://www.510kdatabase.net/k953894/ 1995-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k953894-siemens-multileaf-collimator-fda-510k.jpg K953894 - SIEMENS MULTILEAF COLLIMATOR K953894 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 1995. https://www.510kdatabase.net/k954569/ 1995-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k954569-immulite-theophylline-fda-510k.jpg K954569 - IMMULITE THEOPHYLLINE K954569 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Nov 1995. https://www.510kdatabase.net/k952478/ 1995-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k952478-boehringer-mannheim-cardiac-t-troponin-fda-510k.jpg K952478 - BOEHRINGER MANNHEIM CARDIAC T TROPONIN T RAPID ASSAY K952478 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Nov 1995. https://www.510kdatabase.net/k953730/ 1995-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k953730-codman-anterior-cervical-plate-system-fda-510k.jpg K953730 - CODMAN ANTERIOR CERVICAL PLATE SYSTEM K953730 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Nov 1995. https://www.510kdatabase.net/k950275/ 1995-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k950275-resorbable-soft-tissue-attachment-device-fda-510k.jpg K950275 - RESORBABLE SOFT TISSUE ATTACHMENT DEVICE K950275 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Nov 1995. https://www.510kdatabase.net/k953760/ 1995-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k953760-cordis-wizdom-steerable-guidewire-fda-510k.jpg K953760 - CORDIS WIZDOM STEERABLE GUIDEWIRE K953760 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Nov 1995. https://www.510kdatabase.net/k954085/ 1995-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k954085-models-5866-45-and-5866-46-sizing-sleeve-fda-510k.jpg K954085 - MODELS 5866-45 AND 5866-46 SIZING SLEEVE K954085 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Nov 1995. https://www.510kdatabase.net/k953809/ 1995-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k953809-karl-storz-take-apart-biopolar-forceps-fda-510k.jpg K953809 - KARL STORZ TAKE-APART BIOPOLAR FORCEPS K953809 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Nov 1995. https://www.510kdatabase.net/k951891/ 1995-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k951891-acl-futura-coagulation-system-fda-510k.jpg K951891 - ACL FUTURA COAGULATION SYSTEM K951891 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Nov 1995. https://www.510kdatabase.net/k953650/ 1995-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k953650-depuy-stainless-steel-set-screw-fda-510k.jpg K953650 - DEPUY STAINLESS STEEL SET SCREW K953650 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Nov 1995. https://www.510kdatabase.net/k954218/ 1995-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k954218-sterile-feeding-tube-fda-510k.jpg K954218 - STERILE FEEDING TUBE K954218 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Nov 1995. https://www.510kdatabase.net/k954262/ 1995-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k954262-nexus-ii-femoral-component-fda-510k.jpg K954262 - NEXUS II FEMORAL COMPONENT K954262 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Nov 1995. https://www.510kdatabase.net/k954910/ 1995-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k954910-karl-storz-optical-mediastinoscope-fda-510k.jpg K954910 - KARL STORZ OPTICAL MEDIASTINOSCOPE K954910 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Nov 1995. https://www.510kdatabase.net/k951247/ 1995-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k951247-spiralgold-spiraloxy-hollow-fiber-fda-510k.jpg K951247 - SPIRALGOLD & SPIRALOXY HOLLOW FIBER OXYGENATORS K951247 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Nov 1995. https://www.510kdatabase.net/k953720/ 1995-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k953720-aesculap-caspar-plate-screw-system-for-fda-510k.jpg K953720 - AESCULAP CASPAR PLATE & SCREW SYSTEM FOR ANTERIOR CERVICAL FUSION K953720 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aesculap, Inc.. Cleared Nov 1995. https://www.510kdatabase.net/k954761/ 1995-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k954761-finesse-low-fusing-porcelain-system-fda-510k.jpg K954761 - FINESSE LOW-FUSING PORCELAIN SYSTEM K954761 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Nov 1995. https://www.510kdatabase.net/k953969/ 1995-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k953969-preclude-dura-substitute-fda-510k.jpg K953969 - PRECLUDE DURA SUBSTITUTE K953969 is a FDA 510(k) cleared neurology medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Nov 1995. https://www.510kdatabase.net/k942838/ 1995-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k942838-olympus-superview-laparoscope-for-obgyn-fda-510k.jpg K942838 - OLYMPUS SUPERVIEW LAPAROSCOPE FOR OB/GYN K942838 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Olympus America, Inc.. Cleared Oct 1995. https://www.510kdatabase.net/k953194/ 1995-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k953194-lactosorb-bone-pin-fda-510k.jpg K953194 - LACTOSORB BONE PIN K953194 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Oct 1995. https://www.510kdatabase.net/k953334/ 1995-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k953334-synthes-flexnail-fda-510k.jpg K953334 - SYNTHES FLEXNAIL K953334 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Oct 1995. https://www.510kdatabase.net/k953870/ 1995-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k953870-acttrac-electronic-control-device-for-fda-510k.jpg K953870 - ACTTRAC ELECTRONIC CONTROL DEVICE FOR THE ACT & ACT II COAGULATION INSTRUMENTS K953870 is a FDA 510(k) cleared hematology medical device. Manufacturer: Medtronic Vascular. Cleared Oct 1995. https://www.510kdatabase.net/k953224/ 1995-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k953224-cobas-fp-reagent-application-for-free-fda-510k.jpg K953224 - COBAS FP REAGENT APPLICATION FOR FREE VALPROIC ACID K953224 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Oct 1995. https://www.510kdatabase.net/k953467/ 1995-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k953467-b-d-spinal-anesthesia-tray-spinal-fda-510k.jpg K953467 - B-D SPINAL ANESTHESIA TRAY SPINAL K953467 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1995. https://www.510kdatabase.net/k953595/ 1995-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k953595-magnetic-resonance-diagnostic-accessory-fda-510k.jpg K953595 - MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY K953595 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Oct 1995. https://www.510kdatabase.net/k945585/ 1995-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k945585-comanr-cu-11-model-number-82-6634-fda-510k.jpg K945585 - COMAN(R) CU-11 MODEL NUMBER 82-6634 K945585 is a FDA 510(k) cleared neurology medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Oct 1995. https://www.510kdatabase.net/k953534/ 1995-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k953534-axsym-phencyclidine-ii-fda-510k.jpg K953534 - AXSYM PHENCYCLIDINE II K953534 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1995. https://www.510kdatabase.net/k953841/ 1995-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k953841-sas-salmonella-o-group-a-antigen-fda-510k.jpg K953841 - SAS SALMONELLA O GROUP A ANTIGEN K953841 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Oct 1995. https://www.510kdatabase.net/k953842/ 1995-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k953842-sas-salmonella-h-c-antigen-fda-510k.jpg K953842 - SAS SALMONELLA H C ANTIGEN K953842 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Oct 1995. https://www.510kdatabase.net/k953843/ 1995-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k953843-sas-salmonella-o-group-f-antigen-fda-510k.jpg K953843 - SAS SALMONELLA O GROUP F ANTIGEN K953843 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Oct 1995. https://www.510kdatabase.net/k953844/ 1995-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k953844-sas-salmonella-vi-antigen-fda-510k.jpg K953844 - SAS SALMONELLA VI ANTIGEN K953844 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Oct 1995. https://www.510kdatabase.net/k953846/ 1995-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k953846-sas-salmonella-o-group-c-antigen-fda-510k.jpg K953846 - SAS SALMONELLA O GROUP C ANTIGEN K953846 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Oct 1995. https://www.510kdatabase.net/k953848/ 1995-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k953848-sas-salmonella-o-group-b-antigen-fda-510k.jpg K953848 - SAS SALMONELLA O GROUP B ANTIGEN K953848 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Oct 1995. https://www.510kdatabase.net/k954001/ 1995-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k954001-spetzler-pin-fda-510k.jpg K954001 - SPETZLER PIN K954001 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Oct 1995. https://www.510kdatabase.net/k954346/ 1995-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k954346-chemstrip-micral-urine-test-strips-fda-510k.jpg K954346 - CHEMSTRIP MICRAL URINE TEST STRIPS K954346 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Oct 1995. https://www.510kdatabase.net/k945838/ 1995-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k945838-ctport-ct-simulation-system-for-fda-510k.jpg K945838 - CTPORT CT SIMULATION SYSTEM FOR RADIOTHERAPY K945838 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Oct 1995. https://www.510kdatabase.net/k954000/ 1995-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k954000-roche-reagent-for-bun-fda-510k.jpg K954000 - ROCHE REAGENT FOR BUN K954000 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Oct 1995. https://www.510kdatabase.net/k951919/ 1995-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k951919-b-d-pen-ultra-fda-510k.jpg K951919 - B-D PEN ULTRA K951919 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1995. https://www.510kdatabase.net/k953552/ 1995-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k953552-sienet-spi-spooler-fda-510k.jpg K953552 - SIENET SPI SPOOLER K953552 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 1995. https://www.510kdatabase.net/k953584/ 1995-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k953584-lifeshield-luer-activated-valve-male-fda-510k.jpg K953584 - LIFESHIELD LUER ACTIVATED VALVE MALE ADAPTER PLUG K953584 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1995. https://www.510kdatabase.net/k954021/ 1995-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k954021-external-drainage-system-eds-and-eds-ii-fda-510k.jpg K954021 - EXTERNAL DRAINAGE SYSTEM (EDS AND EDS II) K954021 is a FDA 510(k) cleared neurology medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Oct 1995. https://www.510kdatabase.net/k954196/ 1995-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k954196-universix-120-fda-510k.jpg K954196 - UNIVERSIX 120 K954196 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Oct 1995. https://www.510kdatabase.net/k952482/ 1995-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k952482-ksea-reverse-video-fda-510k.jpg K952482 - KSEA REVERSE VIDEO K952482 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Oct 1995. https://www.510kdatabase.net/k953664/ 1995-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k953664-vitalock-spiked-acetabular-shell-fda-510k.jpg K953664 - VITALOCK SPIKED ACETABULAR SHELL K953664 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Oct 1995. https://www.510kdatabase.net/k954024/ 1995-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k954024-chemstrip-criterion-urine-analyzer-fda-510k.jpg K954024 - CHEMSTRIP CRITERION URINE ANALYZER K954024 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Oct 1995. https://www.510kdatabase.net/k944689/ 1995-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k944689-zirconia-ceramic-femoral-head-fda-510k.jpg K944689 - ZIRCONIA CERAMIC FEMORAL HEAD K944689 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Oct 1995. https://www.510kdatabase.net/k945677/ 1995-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k945677-il682-co-oximeter-fda-510k.jpg K945677 - IL682, CO-OXIMETER K945677 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Oct 1995. https://www.510kdatabase.net/k951105/ 1995-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k951105-karl-storz-pressure-cuff-for-use-with-fda-510k.jpg K951105 - KARL STORZ PRESSURE CUFF FOR USE WITH THE KSEA HYDROMAT PUMP K951105 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Oct 1995. https://www.510kdatabase.net/k951542/ 1995-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k951542-directigen-1-2-3-group-a-strep-test-fda-510k.jpg K951542 - DIRECTIGEN 1-2-3 GROUP A STREP TEST K951542 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1995. https://www.510kdatabase.net/k951820/ 1995-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k951820-thromboplastin-li-reagent-fda-510k.jpg K951820 - THROMBOPLASTIN-LI REAGENT K951820 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Oct 1995. https://www.510kdatabase.net/k953264/ 1995-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k953264-questus-polyester-suture-soft-tissue-fda-510k.jpg K953264 - QUESTUS POLYESTER SUTURE SOFT TISSUE ANCHOR SYSTEM K953264 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Oct 1995. https://www.510kdatabase.net/k953437/ 1995-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k953437-olympus-anti-sterptolysin-o-fda-510k.jpg K953437 - OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENT K953437 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Olympus America, Inc.. Cleared Oct 1995. https://www.510kdatabase.net/k953490/ 1995-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k953490-trilogy-acetabular-shell-liners-36mm-fda-510k.jpg K953490 - TRILOGY ACETABULAR SHELL & LINERS 36MM K953490 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Oct 1995. https://www.510kdatabase.net/k944595/ 1995-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k944595-cordis-horizontal-verical-valve-system-fda-510k.jpg K944595 - CORDIS HORIZONTAL-VERICAL VALVE SYSTEM K944595 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cordis Corp.. Cleared Oct 1995. https://www.510kdatabase.net/k951496/ 1995-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k951496-cell-dyn-3500-multi-parameter-fda-510k.jpg K951496 - CELL-DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER K951496 is a FDA 510(k) cleared hematology medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1995. https://www.510kdatabase.net/k954561/ 1995-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k954561-xenon-noppva-fda-510k.jpg K954561 - XENON NOPPVA K954561 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Oct 1995. https://www.510kdatabase.net/k953533/ 1995-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k953533-radifocus-glidewire-for-coronary-use-fda-510k.jpg K953533 - RADIFOCUS GLIDEWIRE FOR CORONARY USE WITH PLATINUM (OR GOLD) COIL K953533 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Oct 1995. https://www.510kdatabase.net/k953602/ 1995-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k953602-symmetry-small-vessel-balloon-fda-510k.jpg K953602 - SYMMETRY SMALL VESSEL BALLOON DILATATION CATHETER K953602 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Oct 1995. https://www.510kdatabase.net/k953869/ 1995-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k953869-polysorb-ii-coated-synthetic-fda-510k.jpg K953869 - POLYSORB II COATED SYNTHETIC ABSORBABLE SUTURE K953869 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Oct 1995. https://www.510kdatabase.net/k954484/ 1995-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k954484-kodak-automixer-ii-plus-fda-510k.jpg K954484 - KODAK AUTOMIXER II PLUS K954484 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Oct 1995. https://www.510kdatabase.net/k953660/ 1995-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k953660-plum-xl-infusion-pump-modification-fda-510k.jpg K953660 - PLUM XL INFUSION PUMP (MODIFICATION) K953660 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1995. https://www.510kdatabase.net/k954108/ 1995-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k954108-modified-versaport-fda-510k.jpg K954108 - MODIFIED VERSAPORT K954108 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Oct 1995. https://www.510kdatabase.net/k953448/ 1995-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k953448-roche-cobas-micros-hematology-analyzer-fda-510k.jpg K953448 - ROCHE COBAS MICROS HEMATOLOGY ANALYZER K953448 is a FDA 510(k) cleared hematology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Oct 1995. https://www.510kdatabase.net/k951858/ 1995-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k951858-transvenous-permanent-tined-target-tip-fda-510k.jpg K951858 - TRANSVENOUS, PERMANENT TINED TARGET TIP PACING LEADS K951858 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Oct 1995. https://www.510kdatabase.net/k953818/ 1995-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k953818-dall-miles-suturebeaded-cable-fda-510k.jpg K953818 - DALL-MILES SUTURE/BEADED CABLE K953818 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Oct 1995. https://www.510kdatabase.net/k954362/ 1995-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k954362-argistar-74-fda-510k.jpg K954362 - ARGISTAR 74 K954362 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Oct 1995. https://www.510kdatabase.net/k945517/ 1995-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k945517-magnetom-vision-project-016-fda-510k.jpg K945517 - MAGNETOM VISION (PROJECT 016) K945517 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 1995. https://www.510kdatabase.net/k951254/ 1995-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k951254-safetyglide-needle-fda-510k.jpg K951254 - SAFETYGLIDE NEEDLE K951254 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1995. https://www.510kdatabase.net/k951675/ 1995-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k951675-gore-tex-mycromesh-biomaterial-fda-510k.jpg K951675 - GORE-TEX MYCROMESH BIOMATERIAL K951675 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Oct 1995. https://www.510kdatabase.net/k951676/ 1995-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k951676-gore-tex-dualmesh-biomaterial-fda-510k.jpg K951676 - GORE-TEX DUALMESH BIOMATERIAL K951676 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Oct 1995. https://www.510kdatabase.net/k951700/ 1995-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k951700-gore-tex-soft-tissue-patch-fda-510k.jpg K951700 - GORE-TEX SOFT TISSUE PATCH K951700 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Oct 1995. https://www.510kdatabase.net/k953290/ 1995-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k953290-olympus-automatic-surgical-irrigation-fda-510k.jpg K953290 - OLYMPUS AUTOMATIC SURGICAL IRRIGATION PUMP K953290 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Olympus America, Inc.. Cleared Oct 1995. https://www.510kdatabase.net/k954356/ 1995-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k954356-compax-9015e-fda-510k.jpg K954356 - COMPAX 90/15E K954356 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Oct 1995. https://www.510kdatabase.net/k954358/ 1995-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k954358-argendent-gio-86-fr-fda-510k.jpg K954358 - ARGENDENT GIO 86 FR K954358 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Oct 1995. https://www.510kdatabase.net/k954359/ 1995-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k954359-silfree-80sf-fda-510k.jpg K954359 - SILFREE 80SF+ K954359 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Oct 1995. https://www.510kdatabase.net/k954360/ 1995-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k954360-argesol-600-fda-510k.jpg K954360 - ARGESOL 600 K954360 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Oct 1995. https://www.510kdatabase.net/k954361/ 1995-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k954361-argenco-68m-fda-510k.jpg K954361 - ARGENCO 68M K954361 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Oct 1995. https://www.510kdatabase.net/k954367/ 1995-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k954367-argistar-bio-75pf-fda-510k.jpg K954367 - ARGISTAR BIO 75PF K954367 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Oct 1995. https://www.510kdatabase.net/k954368/ 1995-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k954368-argedent-bio-87-pf-fda-510k.jpg K954368 - ARGEDENT BIO 87 PF K954368 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Oct 1995. https://www.510kdatabase.net/k954371/ 1995-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k954371-surefire-s-fda-510k.jpg K954371 - SUREFIRE S K954371 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Oct 1995. https://www.510kdatabase.net/k954404/ 1995-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k954404-aurolite-45-fda-510k.jpg K954404 - AUROLITE 45 K954404 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Oct 1995. https://www.510kdatabase.net/k953115/ 1995-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k953115-axsym-amphetaminemethamphetamine-ii-fda-510k.jpg K953115 - AXSYM AMPHETAMINE/METHAMPHETAMINE II K953115 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1995. https://www.510kdatabase.net/k953287/ 1995-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k953287-diastat-vascular-access-graft-fda-510k.jpg K953287 - DIASTAT VASCULAR ACCESS GRAFT K953287 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Oct 1995. https://www.510kdatabase.net/k953288/ 1995-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k953288-diastat-vascular-access-graft-fda-510k.jpg K953288 - DIASTAT VASCULAR ACCESS GRAFT K953288 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Oct 1995. https://www.510kdatabase.net/k954125/ 1995-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k954125-sauer-endoscope-guide-and-intubation-aid-fda-510k.jpg K954125 - SAUER ENDOSCOPE GUIDE AND INTUBATION AID K954125 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Oct 1995. https://www.510kdatabase.net/k954144/ 1995-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k954144-opus-hcg-controls-fda-510k.jpg K954144 - OPUS HCG CONTROLS K954144 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Oct 1995. https://www.510kdatabase.net/k952779/ 1995-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k952779-karl-storz-flexible-hysterscope-fda-510k.jpg K952779 - KARL STORZ FLEXIBLE HYSTERSCOPE K952779 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Oct 1995. https://www.510kdatabase.net/k953190/ 1995-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k953190-ksea-model-203200-20-unimat-fda-510k.jpg K953190 - KSEA MODEL 203200 20 UNIMAT K953190 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Oct 1995. https://www.510kdatabase.net/k954029/ 1995-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k954029-testpack-plus-hcg-urine-fda-510k.jpg K954029 - TESTPACK PLUS HCG URINE K954029 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1995. https://www.510kdatabase.net/k951371/ 1995-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k951371-1481-t-digital-telemetry-system-with-s-fda-510k.jpg K951371 - 1481 T DIGITAL TELEMETRY SYSTEM WITH S-T SEGMENT ANALYSIS OPTION K951371 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 1995. https://www.510kdatabase.net/k946179/ 1995-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k946179-siemens-sonoline-4xx-fda-510k.jpg K946179 - SIEMENS SONOLINE 4XX K946179 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 1995. https://www.510kdatabase.net/k950821/ 1995-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k950821-hp-m1205a-omnicare-component-transport-fda-510k.jpg K950821 - HP M1205A OMNICARE COMPONENT TRANSPORT MONITORING SYSTEM MODEL 24 K950821 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Oct 1995. https://www.510kdatabase.net/k952239/ 1995-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k952239-auto-suture-modified-linear-stapler-fda-510k.jpg K952239 - AUTO SUTURE* MODIFIED LINEAR STAPLER** K952239 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Oct 1995. https://www.510kdatabase.net/k953173/ 1995-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k953173-nonpowered-neurosurgical-instrument-fda-510k.jpg K953173 - NONPOWERED NEUROSURGICAL INSTRUMENT K953173 is a FDA 510(k) cleared neurology medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Oct 1995. https://www.510kdatabase.net/k953979/ 1995-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k953979-apolipoprotein-calibrator-apo-cal-fda-510k.jpg K953979 - APOLIPOPROTEIN CALIBRATOR (APO-CAL) K953979 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Oct 1995. https://www.510kdatabase.net/k953743/ 1995-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k953743-palasplint-fda-510k.jpg K953743 - PALASPLINT K953743 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Oct 1995. https://www.510kdatabase.net/k940973/ 1995-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k940973-mullan-ganglion-microcompression-set-fda-510k.jpg K940973 - MULLAN GANGLION MICROCOMPRESSION SET K940973 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cook, Inc.. Cleared Sep 1995. https://www.510kdatabase.net/k951738/ 1995-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k951738-argyle-neo-sert-triple-lumen-umbilical-fda-510k.jpg K951738 - ARGYLE NEO-SERT TRIPLE LUMEN UMBILICAL VESSEL CATHETER K951738 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Sep 1995. https://www.510kdatabase.net/k952923/ 1995-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k952923-intramedullary-compression-arthrodesis-fda-510k.jpg K952923 - INTRAMEDULLARY COMPRESSION ARTHRODESIS (ICA) NAIL K952923 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Sep 1995. https://www.510kdatabase.net/k953221/ 1995-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k953221-abbott-vision-hemoglobin-modification-fda-510k.jpg K953221 - ABBOTT VISION HEMOGLOBIN (MODIFICATION) K953221 is a FDA 510(k) cleared hematology medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1995. https://www.510kdatabase.net/k953446/ 1995-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k953446-aesculap-bipolar-cords-fda-510k.jpg K953446 - AESCULAP BIPOLAR CORDS K953446 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Sep 1995. https://www.510kdatabase.net/k953868/ 1995-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k953868-grasping-forceps-biopsy-forceps-fda-510k.jpg K953868 - GRASPING FORCEPS, BIOPSY FORCEPS, SCISSORS, PUNCH K953868 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Sep 1995. https://www.510kdatabase.net/k951737/ 1995-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k951737-argyle-neo-sert-triple-lumen-umbilical-fda-510k.jpg K951737 - ARGYLE NEO-SERT TRIPLE LUMEN UMBILICAL VESSEL CATHETER INSERTION TRAY K951737 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Sep 1995. https://www.510kdatabase.net/k954067/ 1995-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k954067-3m-model-8295-fda-510k.jpg K954067 - 3M MODEL 8295 K954067 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: 3M Company. Cleared Sep 1995. https://www.510kdatabase.net/k953765/ 1995-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k953765-axsym-rea-ethanol-fda-510k.jpg K953765 - AXSYM REA ETHANOL K953765 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1995. https://www.510kdatabase.net/k954115/ 1995-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k954115-artglass-kevloc-fda-510k.jpg K954115 - ARTGLASS & KEVLOC K954115 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Sep 1995. https://www.510kdatabase.net/k944538/ 1995-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k944538-gas-plasma-sterilization-fda-510k.jpg K944538 - GAS PLASMA STERILIZATION K944538 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Sep 1995. https://www.510kdatabase.net/k945914/ 1995-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k945914-bipolar-generator-model-2352-fda-510k.jpg K945914 - BIPOLAR GENERATOR MODEL 2352 K945914 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Sep 1995. https://www.510kdatabase.net/k953531/ 1995-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k953531-howmedica-mainstay-anchor-fda-510k.jpg K953531 - HOWMEDICA MAINSTAY ANCHOR K953531 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Sep 1995. https://www.510kdatabase.net/k953596/ 1995-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k953596-distending-diverticuloscope-fda-510k.jpg K953596 - DISTENDING DIVERTICULOSCOPE K953596 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Sep 1995. https://www.510kdatabase.net/k953239/ 1995-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k953239-boehringer-mannheimhitachi-917-analyzer-fda-510k.jpg K953239 - BOEHRINGER MANNHEIM/HITACHI 917 ANALYZER K953239 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Sep 1995. https://www.510kdatabase.net/k953718/ 1995-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k953718-axsym-digoxin-ii-fda-510k.jpg K953718 - AXSYM DIGOXIN II K953718 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1995. https://www.510kdatabase.net/k953840/ 1995-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k953840-axsym-phenytoin-ii-fda-510k.jpg K953840 - AXSYM PHENYTOIN II K953840 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1995. https://www.510kdatabase.net/k953082/ 1995-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k953082-iliac-crest-bone-marrow-aspiration-fda-510k.jpg K953082 - ILIAC CREST BONE MARROW ASPIRATION NEEDLE K953082 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Baxter Healthcare Corp. Cleared Sep 1995. https://www.510kdatabase.net/k952427/ 1995-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k952427-cx-alanine-cx-aspartate-fda-510k.jpg K952427 - CX ALANINE, CX ASPARTATE AMINOTRANSFERASE-PYRIDOXAL-5-PHOSPHATE, CX CREATINE PHOSPHOKINASE-N-ACETYL-L-CYSTEINE K952427 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Sep 1995. https://www.510kdatabase.net/k953023/ 1995-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k953023-preceder-guidewire-fda-510k.jpg K953023 - PRECEDER GUIDEWIRE K953023 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Sep 1995. https://www.510kdatabase.net/k942706/ 1995-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k942706-roche-calibrator-serum-fda-510k.jpg K942706 - ROCHE CALIBRATOR SERUM K942706 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Sep 1995. https://www.510kdatabase.net/k953739/ 1995-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k953739-abuscreen-online-controls-fda-510k.jpg K953739 - ABUSCREEN ONLINE CONTROLS K953739 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Sep 1995. https://www.510kdatabase.net/k953845/ 1995-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k953845-abuscreen-online-drug-free-urine-fda-510k.jpg K953845 - ABUSCREEN ONLINE DRUG FREE URINE K953845 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Sep 1995. https://www.510kdatabase.net/k933825/ 1995-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k933825-adi-system-fda-510k.jpg K933825 - ADI SYSTEM K933825 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1995. https://www.510kdatabase.net/k952068/ 1995-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k952068-ethylene-oxide-sterilization-of-fda-510k.jpg K952068 - ETHYLENE OXIDE STERILIZATION OF POLYETHYLENE ORTHOPEDIC DEVICES K952068 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Sep 1995. https://www.510kdatabase.net/k952686/ 1995-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k952686-buchalter-fauser-femoral-components-fda-510k.jpg K952686 - BUCHALTER FAUSER FEMORAL COMPONENTS K952686 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Sep 1995. https://www.510kdatabase.net/k940743/ 1995-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k940743-uhmwpe-components-change-in-packaging-fda-510k.jpg K940743 - UHMWPE COMPONENTS-CHANGE IN PACKAGING K940743 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Sep 1995. https://www.510kdatabase.net/k940861/ 1995-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k940861-pcar-modular-total-knee-tib-insert-fda-510k.jpg K940861 - PCA(R) MODULAR TOTAL KNEE TIB INSERT DUROCON BASEPLATE K940861 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Sep 1995. https://www.510kdatabase.net/k945827/ 1995-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k945827-outlook-fda-510k.jpg K945827 - OUTLOOK K945827 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Sep 1995. https://www.510kdatabase.net/k952888/ 1995-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k952888-olympus-imagemanager-system-version-60-fda-510k.jpg K952888 - OLYMPUS IMAGEMANAGER SYSTEM VERSION 6.0 FOR WINDOWS K952888 is a FDA 510(k) cleared radiology medical device. Manufacturer: Olympus America, Inc.. Cleared Sep 1995. https://www.510kdatabase.net/k934327/ 1995-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k934327-arthrex-suture-anchor-screw-system-fda-510k.jpg K934327 - ARTHREX SUTURE ANCHOR SCREW SYSTEM K934327 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Sep 1995. https://www.510kdatabase.net/k944200/ 1995-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k944200-hi-q-hand-instruments-obgyn-use-fda-510k.jpg K944200 - HI-Q HAND INSTRUMENTS, OB/GYN USE K944200 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Olympus America, Inc.. Cleared Sep 1995. https://www.510kdatabase.net/k952282/ 1995-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k952282-roche-ammoniaethanolco2-calibrator-fda-510k.jpg K952282 - ROCHE AMMONIA/ETHANOL/CO2 CALIBRATOR K952282 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Sep 1995. https://www.510kdatabase.net/k952918/ 1995-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k952918-ptfe-syringe-filter-fda-510k.jpg K952918 - PTFE SYRINGE FILTER K952918 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Sep 1995. https://www.510kdatabase.net/k954122/ 1995-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k954122-take-apart-scissors-fda-510k.jpg K954122 - TAKE-APART SCISSORS K954122 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Sep 1995. https://www.510kdatabase.net/k953004/ 1995-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k953004-dilatation-catheter-balloon-fda-510k.jpg K953004 - DILATATION CATHETER, BALLOON K953004 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Sep 1995. https://www.510kdatabase.net/k953114/ 1995-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k953114-evolution-microcatheter-fda-510k.jpg K953114 - EVOLUTION MICROCATHETER K953114 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Sep 1995. https://www.510kdatabase.net/k953528/ 1995-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k953528-roche-cobas-fp-reagents-for-vancomycin-fda-510k.jpg K953528 - ROCHE COBAS-FP REAGENTS FOR VANCOMYCIN K953528 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Sep 1995. https://www.510kdatabase.net/k953832/ 1995-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k953832-solarix-fv-fda-510k.jpg K953832 - SOLARIX FV K953832 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Sep 1995. https://www.510kdatabase.net/k954011/ 1995-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k954011-fascia-closure-device-fda-510k.jpg K954011 - FASCIA CLOSURE DEVICE K954011 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Sep 1995. https://www.510kdatabase.net/k951595/ 1995-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k951595-roche-cobas-integra-analyzer-reagent-fda-510k.jpg K951595 - ROCHE COBAS INTEGRA ANALYZER, REAGENT CASSETTES K951595 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Sep 1995. https://www.510kdatabase.net/k951725/ 1995-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k951725-osteonics-spinal-system-fda-510k.jpg K951725 - OSTEONICS SPINAL SYSTEM K951725 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Sep 1995. https://www.510kdatabase.net/k952251/ 1995-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k952251-immulite-hcg-high-level-control-module-fda-510k.jpg K952251 - IMMULITE HCG HIGH LEVEL CONTROL MODULE K952251 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Sep 1995. https://www.510kdatabase.net/k952252/ 1995-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k952252-adp-reagent-modified-fda-510k.jpg K952252 - ADP REAGENT, MODIFIED K952252 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Sep 1995. https://www.510kdatabase.net/k952730/ 1995-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k952730-hoffmann-ii-external-fixation-system-fda-510k.jpg K952730 - HOFFMANN II EXTERNAL FIXATION SYSTEM K952730 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Sep 1995. https://www.510kdatabase.net/k953025/ 1995-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k953025-slt-28mm-xxl-femoral-head-fda-510k.jpg K953025 - SLT 28MM XXL FEMORAL HEAD K953025 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Sep 1995. https://www.510kdatabase.net/k951250/ 1995-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k951250-karl-storz-suction-catheters-fda-510k.jpg K951250 - KARL STORZ SUCTION CATHETERS K951250 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Sep 1995. https://www.510kdatabase.net/k951671/ 1995-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k951671-osteonics-restoration-monolithic-ii-fda-510k.jpg K951671 - OSTEONICS RESTORATION MONOLITHIC II SLOTTED HIP STEM SERIES K951671 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Sep 1995. https://www.510kdatabase.net/k953370/ 1995-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k953370-karl-storz-ent-shaver-fda-510k.jpg K953370 - KARL STORZ ENT SHAVER K953370 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Sep 1995. https://www.510kdatabase.net/k953724/ 1995-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k953724-cronex-radiation-therapy-cassette-fda-510k.jpg K953724 - CRONEX RADIATION THERAPY CASSETTE K953724 is a FDA 510(k) cleared radiology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Sep 1995. https://www.510kdatabase.net/k953725/ 1995-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k953725-cronex-radiation-therapy-verification-fda-510k.jpg K953725 - CRONEX RADIATION THERAPY VERIFICATION CASSETTE K953725 is a FDA 510(k) cleared radiology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Sep 1995. https://www.510kdatabase.net/k953849/ 1995-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k953849-prism-electroscope-fda-510k.jpg K953849 - PRISM ELECTROSCOPE K953849 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Sep 1995. https://www.510kdatabase.net/k951497/ 1995-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k951497-cascase-480-snslyzer-fda-510k.jpg K951497 - CASCASE 480 SNSLYZER K951497 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Sep 1995. https://www.510kdatabase.net/k951932/ 1995-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k951932-osteonics-restoration-monolithic-ii-fda-510k.jpg K951932 - OSTEONICS RESTORATION MONOLITHIC II HIP STEM SERIES K951932 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Sep 1995. https://www.510kdatabase.net/k953075/ 1995-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k953075-unimat-pump-fda-510k.jpg K953075 - UNIMAT PUMP K953075 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Sep 1995. https://www.510kdatabase.net/k953366/ 1995-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k953366-quanta-lite-iga-aca-hrp-fda-510k.jpg K953366 - QUANTA LITE IGA ACA (HRP) K953366 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Sep 1995. https://www.510kdatabase.net/k952459/ 1995-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k952459-medtronic-model-3991-3991c-3992-3992c-fda-510k.jpg K952459 - MEDTRONIC MODEL 3991, 3991C, 3992, 3992C, 3993, 3993C, 3994, 3994C LEADS OR, TRANSVERSE TRIPOLAR LEADS OR, TTL K952459 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Aug 1995. https://www.510kdatabase.net/k944931/ 1995-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k944931-becton-dickinson-blunt-steel-cannula-fda-510k.jpg K944931 - BECTON DICKINSON BLUNT STEEL CANNULA K944931 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1995. https://www.510kdatabase.net/k953291/ 1995-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k953291-quanta-lite-aca-screen-hrp-fda-510k.jpg K953291 - QUANTA LITE ACA SCREEN (HRP) K953291 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Aug 1995. https://www.510kdatabase.net/k951321/ 1995-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k951321-radias-neonatal-t4-enzyme-immunoassay-fda-510k.jpg K951321 - RADIAS NEONATAL T4 ENZYME IMMUNOASSAY K951321 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Aug 1995. https://www.510kdatabase.net/k951863/ 1995-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k951863-roller-electrode-fda-510k.jpg K951863 - ROLLER ELECTRODE K951863 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus America, Inc.. Cleared Aug 1995. https://www.510kdatabase.net/k951887/ 1995-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k951887-advantage-test-strips-fda-510k.jpg K951887 - ADVANTAGE TEST STRIPS K951887 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Aug 1995. https://www.510kdatabase.net/k952839/ 1995-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k952839-boehringer-mannheim-ethyl-alcohol-assay-fda-510k.jpg K952839 - BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAY K952839 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Aug 1995. https://www.510kdatabase.net/k953016/ 1995-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k953016-axsym-theophylline-ii-fda-510k.jpg K953016 - AXSYM THEOPHYLLINE II K953016 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1995. https://www.510kdatabase.net/k953094/ 1995-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k953094-axsym-acetaminophen-fda-510k.jpg K953094 - AXSYM ACETAMINOPHEN K953094 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1995. https://www.510kdatabase.net/k953097/ 1995-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k953097-opus-t4-controls-fda-510k.jpg K953097 - OPUS T4 CONTROLS K953097 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Aug 1995. https://www.510kdatabase.net/k953160/ 1995-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k953160-opus-t3-fda-510k.jpg K953160 - OPUS T3 K953160 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Aug 1995. https://www.510kdatabase.net/k953520/ 1995-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k953520-olympus-rheumatoid-factor-fda-510k.jpg K953520 - OLYMPUS RHEUMATOID FACTOR IMMUNOTURBIDIMETRIC REAGENT K953520 is a FDA 510(k) cleared immunology medical device. Manufacturer: Olympus America, Inc.. Cleared Aug 1995. https://www.510kdatabase.net/k945779/ 1995-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k945779-magnetom-vision-project-016-fda-510k.jpg K945779 - MAGNETOM VISION (PROJECT 016) K945779 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 1995. https://www.510kdatabase.net/k950337/ 1995-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k950337-karl-storz-stammberger-sachse-fda-510k.jpg K950337 - KARL STORZ STAMMBERGER-SACHSE INTRANASAL-FRILL K950337 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Aug 1995. https://www.510kdatabase.net/k950680/ 1995-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k950680-infant-heel-warmer-fda-510k.jpg K950680 - INFANT HEEL WARMER K950680 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Baxter Healthcare Corp. Cleared Aug 1995. https://www.510kdatabase.net/k952109/ 1995-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k952109-ip500-nuclear-gamma-camera-system-fda-510k.jpg K952109 - IP500 NUCLEAR GAMMA CAMERA SYSTEM K952109 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 1995. https://www.510kdatabase.net/k952945/ 1995-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k952945-aquaflo-hydrogel-wound-dressing-packer-fda-510k.jpg K952945 - AQUAFLO HYDROGEL WOUND DRESSING & PACKER K952945 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sherwood Medical Co.. Cleared Aug 1995. https://www.510kdatabase.net/k953132/ 1995-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k953132-uimat-pump-fda-510k.jpg K953132 - UIMAT PUMP K953132 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Aug 1995. https://www.510kdatabase.net/k953455/ 1995-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k953455-opus-b12-fda-510k.jpg K953455 - OPUS B12 K953455 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Aug 1995. https://www.510kdatabase.net/k953543/ 1995-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k953543-3m-model-8200p-multipro-bte-fda-510k.jpg K953543 - 3M MODEL 8200P MULTIPRO BTE K953543 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: 3M Company. Cleared Aug 1995. https://www.510kdatabase.net/k953550/ 1995-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k953550-co2-arthroflator-fda-510k.jpg K953550 - CO2 ARTHROFLATOR K953550 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Aug 1995. https://www.510kdatabase.net/k945285/ 1995-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k945285-ussc-monofilament-polysorb-suture-fda-510k.jpg K945285 - USSC MONOFILAMENT POLYSORB SUTURE K945285 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Aug 1995. https://www.510kdatabase.net/k951520/ 1995-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k951520-ussc-polysorb-suture-fda-510k.jpg K951520 - USSC POLYSORB SUTURE K951520 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Aug 1995. https://www.510kdatabase.net/k951626/ 1995-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k951626-synthes-usa-universal-spinal-hook-rod-fda-510k.jpg K951626 - SYNTHES (U.S.A.) UNIVERSAL SPINAL HOOK, ROD AND PEDICLE/SACRAL SCREW FIXATION SYSTEM K951626 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Aug 1995. https://www.510kdatabase.net/k951794/ 1995-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k951794-synthes-usa-univ-screw-fixation-system-fda-510k.jpg K951794 - SYNTHES (USA) UNIV. SCREW FIXATION SYSTEM (TITANIUM) K951794 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Aug 1995. https://www.510kdatabase.net/k953067/ 1995-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k953067-hip-fracture-stem-fenestration-plug-fda-510k.jpg K953067 - HIP FRACTURE STEM FENESTRATION PLUG K953067 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Aug 1995. https://www.510kdatabase.net/k953549/ 1995-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k953549-ksea-extraction-bag-fda-510k.jpg K953549 - KSEA EXTRACTION BAG K953549 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Aug 1995. https://www.510kdatabase.net/k934060/ 1995-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k934060-howmedicar-acetabular-comp-packmanuf-fda-510k.jpg K934060 - HOWMEDICA(R) ACETABULAR COMP PACK/MANUF METH CHANGE K934060 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Aug 1995. https://www.510kdatabase.net/k936292/ 1995-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k936292-packaging-and-manufacturing-methods-fda-510k.jpg K936292 - PACKAGING AND MANUFACTURING METHODS CHANGE/KNEE COMPONENTS K936292 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Aug 1995. https://www.510kdatabase.net/k950395/ 1995-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k950395-thermocool-system-fda-510k.jpg K950395 - THERMOCOOL SYSTEM K950395 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zimmer, Inc.. Cleared Aug 1995. https://www.510kdatabase.net/k951413/ 1995-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k951413-fogarty-hydragrip-surgical-clamps-fda-510k.jpg K951413 - FOGARTY-HYDRAGRIP SURGICAL CLAMPS K951413 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Aug 1995. https://www.510kdatabase.net/k952296/ 1995-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k952296-synthes-usa-synthes-self-drilling-fda-510k.jpg K952296 - SYNTHES (USA) [SYNTHES[ SELF-DRILLING SCHANZ SCREW K952296 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Aug 1995. https://www.510kdatabase.net/k952740/ 1995-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k952740-depuy-duraloc-400-acetabular-cup-fda-510k.jpg K952740 - DEPUY DURALOC 400 ACETABULAR CUP K952740 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Aug 1995. https://www.510kdatabase.net/k952828/ 1995-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k952828-medi-tech-percutaneous-introducer-system-fda-510k.jpg K952828 - MEDI-TECH PERCUTANEOUS INTRODUCER SYSTEM K952828 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Aug 1995. https://www.510kdatabase.net/k950882/ 1995-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k950882-braun-selective-angiographic-catheter-fda-510k.jpg K950882 - BRAUN SELECTIVE ANGIOGRAPHIC CATHETER K950882 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Aug 1995. https://www.510kdatabase.net/k952180/ 1995-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k952180-cx-lipase-reagent-calibrator-for-fda-510k.jpg K952180 - CX LIPASE REAGENT & CALIBRATOR FOR SYNCHRON CX SYSTEMS K952180 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Aug 1995. https://www.510kdatabase.net/k951855/ 1995-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k951855-ultrathin-ureteroscopes-fda-510k.jpg K951855 - ULTRATHIN URETEROSCOPES K951855 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus America, Inc.. Cleared Aug 1995. https://www.510kdatabase.net/k953509/ 1995-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k953509-bipolar-coagulating-forceps-fda-510k.jpg K953509 - BIPOLAR COAGULATING FORCEPS K953509 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Aug 1995. https://www.510kdatabase.net/k953014/ 1995-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k953014-alastat-microplate-latex-specific-ige-fda-510k.jpg K953014 - ALASTAT MICROPLATE LATEX-SPECIFIC IGE ALLERGEN K953014 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Aug 1995. https://www.510kdatabase.net/k933882/ 1995-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k933882-osteonics-ps-hemi-hip-stem-series-fda-510k.jpg K933882 - OSTEONICS PS HEMI-HIP STEM SERIES K933882 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Aug 1995. https://www.510kdatabase.net/k943778/ 1995-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k943778-osteonics-restoration-cemented-hip-fda-510k.jpg K943778 - OSTEONICS RESTORATION CEMENTED HIP STEM SERIES K943778 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Aug 1995. https://www.510kdatabase.net/k945571/ 1995-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k945571-abbott-test-pack-strep-a-test-fda-510k.jpg K945571 - ABBOTT TEST PACK STREP A TEST K945571 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1995. https://www.510kdatabase.net/k950074/ 1995-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k950074-wright-loctm-spinal-fixation-system-fda-510k.jpg K950074 - WRIGHT-LOC(TM) SPINAL FIXATION SYSTEM K950074 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Aug 1995. https://www.510kdatabase.net/k951331/ 1995-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k951331-accusport-lactate-monitoring-system-fda-510k.jpg K951331 - ACCUSPORT LACTATE MONITORING SYSTEM LACTATE TEST STRIPS ACCUSPORT MONITOR K951331 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Aug 1995. https://www.510kdatabase.net/k951584/ 1995-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k951584-alkaline-phosphatase-alpamp-procedure-fda-510k.jpg K951584 - ALKALINE PHOSPHATASE (ALP/AMP) PROCEDURE NO. 247 K951584 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Aug 1995. https://www.510kdatabase.net/k951949/ 1995-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k951949-clear-hub-spinal-needle-18-20-22-25-ga-fda-510k.jpg K951949 - CLEAR HUB SPINAL NEEDLE, 18, 20, 22, 25 GA. K951949 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Aug 1995. https://www.510kdatabase.net/k951956/ 1995-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k951956-osteonics-series-7000-total-knee-full-fda-510k.jpg K951956 - OSTEONICS SERIES 7000 TOTAL KNEE FULL TIBIAL BONE AUGEMENTATION BLOCKS & WEDGES K951956 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Aug 1995. https://www.510kdatabase.net/k952173/ 1995-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k952173-hewlett-packard-model-m1264b-cathstation-fda-510k.jpg K952173 - HEWLETT-PACKARD MODEL M1264B CATHSTATION K952173 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Aug 1995. https://www.510kdatabase.net/k952221/ 1995-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k952221-bscca-30-40-sensation-models-930-940-fda-510k.jpg K952221 - BSC/CA 30 & 40 SENSATION, MODELS 930 & 940 K952221 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Aug 1995. https://www.510kdatabase.net/k953336/ 1995-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k953336-vrs-3-wall-stand-fda-510k.jpg K953336 - VRS 3 WALL STAND K953336 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Aug 1995. https://www.510kdatabase.net/k953402/ 1995-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k953402-universix-190-fda-510k.jpg K953402 - UNIVERSIX 190 K953402 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Aug 1995. https://www.510kdatabase.net/k952748/ 1995-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k952748-auto-suture-chemosite-implantable-drug-fda-510k.jpg K952748 - AUTO SUTURE* CHEMOSITE IMPLANTABLE DRUG DELIVERY SYSTEM** K952748 is a FDA 510(k) cleared general hospital medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Aug 1995. https://www.510kdatabase.net/k952968/ 1995-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k952968-dilatation-catheter-balloon-fda-510k.jpg K952968 - DILATATION CATHETER, BALLOON K952968 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Aug 1995. https://www.510kdatabase.net/k936008/ 1995-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k936008-duracon-baseplates-fda-510k.jpg K936008 - DURACON BASEPLATES K936008 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Aug 1995. https://www.510kdatabase.net/k945730/ 1995-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k945730-signa-profile-fda-510k.jpg K945730 - SIGNA PROFILE K945730 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Aug 1995. https://www.510kdatabase.net/k951291/ 1995-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k951291-osteonics-restoration-monolithic-hip-fda-510k.jpg K951291 - OSTEONICS RESTORATION MONOLITHIC HIP STEM K951291 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Aug 1995. https://www.510kdatabase.net/k951471/ 1995-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k951471-strickland-trapezial-implant-fda-510k.jpg K951471 - STRICKLAND TRAPEZIAL IMPLANT K951471 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Aug 1995. https://www.510kdatabase.net/k952443/ 1995-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k952443-karl-storz-endoscopy-powder-blower-fda-510k.jpg K952443 - KARL STORZ ENDOSCOPY POWDER BLOWER K952443 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Aug 1995. https://www.510kdatabase.net/k953164/ 1995-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k953164-alalysis-package-for-dental-fda-510k.jpg K953164 - ALALYSIS PACKAGE FOR DENTAL APPLICATIONS FOR XPEED, XPRESS, XVISION K953164 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Aug 1995. https://www.510kdatabase.net/k951290/ 1995-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k951290-axsym-salicylate-fda-510k.jpg K951290 - AXSYM SALICYLATE K951290 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1995. https://www.510kdatabase.net/k952568/ 1995-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k952568-beckman-array-tobramycin-tob-reagent-fda-510k.jpg K952568 - BECKMAN ARRAY TOBRAMYCIN (TOB) REAGENT K952568 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Aug 1995. https://www.510kdatabase.net/k945773/ 1995-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k945773-siemens-sonoline-versa-fda-510k.jpg K945773 - SIEMENS SONOLINE VERSA K945773 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 1995. https://www.510kdatabase.net/k951529/ 1995-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k951529-v-mueller-obstetrical-ob-forceps-fda-510k.jpg K951529 - V. MUELLER OBSTETRICAL (OB) FORCEPS K951529 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Aug 1995. https://www.510kdatabase.net/k951694/ 1995-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k951694-electronic-laparoflator-fda-510k.jpg K951694 - ELECTRONIC LAPAROFLATOR K951694 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Aug 1995. https://www.510kdatabase.net/k952646/ 1995-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k952646-il-test-ck-mb-fda-510k.jpg K952646 - IL TEST CK-MB K952646 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Aug 1995. https://www.510kdatabase.net/k953316/ 1995-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k953316-sas-shigella-dysenteriae-group-a-1-7-fda-510k.jpg K953316 - SAS SHIGELLA DYSENTERIAE GROUP A (1-7) ANTISERUM K953316 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Aug 1995. https://www.510kdatabase.net/k953317/ 1995-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k953317-sas-shigella-dysenteriae-type-7-fda-510k.jpg K953317 - SAS SHIGELLA DYSENTERIAE TYPE 7 ANTISERUM K953317 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Aug 1995. https://www.510kdatabase.net/k953318/ 1995-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k953318-sas-shigella-dysenteriae-type-6-fda-510k.jpg K953318 - SAS SHIGELLA DYSENTERIAE TYPE 6 ANTISERUM K953318 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Aug 1995. https://www.510kdatabase.net/k953319/ 1995-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k953319-sas-shigella-dysenteriae-type-5-fda-510k.jpg K953319 - SAS SHIGELLA DYSENTERIAE TYPE 5 ANTISERUM K953319 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Aug 1995. https://www.510kdatabase.net/k953320/ 1995-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k953320-sas-shigella-dysenteriae-type-4-fda-510k.jpg K953320 - SAS SHIGELLA DYSENTERIAE TYPE 4 ANTISERUM K953320 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Aug 1995. https://www.510kdatabase.net/k953321/ 1995-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k953321-sas-shigella-dysenteriae-type-3-fda-510k.jpg K953321 - SAS SHIGELLA DYSENTERIAE TYPE 3 ANTISERUM K953321 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Aug 1995. https://www.510kdatabase.net/k951289/ 1995-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k951289-axsym-cocaine-metabolite-fda-510k.jpg K951289 - AXSYM COCAINE METABOLITE K951289 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1995. https://www.510kdatabase.net/k952185/ 1995-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k952185-cordis-brite-tip-envoy-guiding-catheter-fda-510k.jpg K952185 - CORDIS BRITE TIP, ENVOY GUIDING CATHETER K952185 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Aug 1995. https://www.510kdatabase.net/k953322/ 1995-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k953322-sas-shigella-boydii-type-1-antiserum-fda-510k.jpg K953322 - SAS SHIGELLA BOYDII TYPE 1 ANTISERUM K953322 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Aug 1995. https://www.510kdatabase.net/k953323/ 1995-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k953323-sas-shigella-boydii-type-2-antiserum-fda-510k.jpg K953323 - SAS SHIGELLA BOYDII TYPE 2 ANTISERUM K953323 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Aug 1995. https://www.510kdatabase.net/k953324/ 1995-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k953324-sas-shigella-boydii-type-3-antiserun-fda-510k.jpg K953324 - SAS SHIGELLA BOYDII TYPE 3 ANTISERUN K953324 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Aug 1995. https://www.510kdatabase.net/k953325/ 1995-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k953325-sas-shigella-boydii-type-4-antiserum-fda-510k.jpg K953325 - SAS SHIGELLA BOYDII TYPE 4 ANTISERUM K953325 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Aug 1995. https://www.510kdatabase.net/k953326/ 1995-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k953326-sas-shigella-boydii-type-5-antiserum-fda-510k.jpg K953326 - SAS SHIGELLA BOYDII TYPE 5 ANTISERUM K953326 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Aug 1995. https://www.510kdatabase.net/k953327/ 1995-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k953327-sas-shigella-boydii-type-6-antiserum-fda-510k.jpg K953327 - SAS SHIGELLA BOYDII TYPE 6 ANTISERUM K953327 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Aug 1995. https://www.510kdatabase.net/k953328/ 1995-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k953328-sas-shigella-boydii-type-7-antiserum-fda-510k.jpg K953328 - SAS SHIGELLA BOYDII TYPE 7 ANTISERUM K953328 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Aug 1995. https://www.510kdatabase.net/k953329/ 1995-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k953329-sas-shigella-boydii-group-c2-antiserum-fda-510k.jpg K953329 - SAS SHIGELLA BOYDII GROUP C2 ANTISERUM K953329 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Aug 1995. https://www.510kdatabase.net/k953338/ 1995-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k953338-injection-needle-fda-510k.jpg K953338 - INJECTION NEEDLE K953338 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Aug 1995. https://www.510kdatabase.net/k951636/ 1995-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k951636-imx-toxo-igg-fda-510k.jpg K951636 - IMX TOXO IGG K951636 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1995. https://www.510kdatabase.net/k951961/ 1995-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k951961-ksea-model-26012ch-electronic-fda-510k.jpg K951961 - KSEA MODEL 26012CH ELECTRONIC LAPAROFLATOR K951961 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Aug 1995. https://www.510kdatabase.net/k952817/ 1995-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k952817-bio-rad-urinary-5-hiaa-by-hplc-fda-510k.jpg K952817 - BIO-RAD URINARY 5-HIAA BY HPLC K952817 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Aug 1995. https://www.510kdatabase.net/k952272/ 1995-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k952272-ti-alloy-20-mm-cortex-screw-fda-510k.jpg K952272 - TI. ALLOY 2.0 MM CORTEX SCREW K952272 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jul 1995. https://www.510kdatabase.net/k952555/ 1995-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k952555-cobas-fp-application-for-free-fda-510k.jpg K952555 - COBAS-FP APPLICATION FOR FREE PHENYTOIN, COBAS-FP PHENYTOIN CALIBRATORS, & CONTROLS K952555 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jul 1995. https://www.510kdatabase.net/k952640/ 1995-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k952640-cannulated-plus-hip-screw-fda-510k.jpg K952640 - CANNULATED PLUS HIP SCREW K952640 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jul 1995. https://www.510kdatabase.net/k952926/ 1995-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k952926-questus-disposable-endoscopic-knife-fda-510k.jpg K952926 - QUESTUS DISPOSABLE ENDOSCOPIC KNIFE K952926 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jul 1995. https://www.510kdatabase.net/k944222/ 1995-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k944222-codman-medos-valve-shunt-system-fda-510k.jpg K944222 - CODMAN-MEDOS VALVE SHUNT SYSTEM K944222 is a FDA 510(k) cleared neurology medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jul 1995. https://www.510kdatabase.net/k952074/ 1995-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k952074-solution-set-with-12-micron-air-fda-510k.jpg K952074 - SOLUTION SET WITH 1.2 MICRON AIR ELIMINATING FILTER K952074 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jul 1995. https://www.510kdatabase.net/k952008/ 1995-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k952008-karl-storz-drill-fda-510k.jpg K952008 - KARL STORZ DRILL K952008 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jul 1995. https://www.510kdatabase.net/k943308/ 1995-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k943308-model-510-infant-monitor-fda-510k.jpg K943308 - MODEL 510 INFANT MONITOR K943308 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Jul 1995. https://www.510kdatabase.net/k943917/ 1995-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k943917-capiox-arterial-filter-fda-510k.jpg K943917 - CAPIOX ARTERIAL FILTER K943917 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Jul 1995. https://www.510kdatabase.net/k952288/ 1995-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k952288-sas-salmonella-h-c-antiserum-fda-510k.jpg K952288 - SAS SALMONELLA H C ANTISERUM K952288 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Jul 1995. https://www.510kdatabase.net/k952696/ 1995-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k952696-xenon-light-source-model-5121-fda-510k.jpg K952696 - XENON LIGHT SOURCE MODEL 5121 K952696 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Jul 1995. https://www.510kdatabase.net/k952530/ 1995-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k952530-headneck-vascular-phased-array-coil-fda-510k.jpg K952530 - HEAD/NECK VASCULAR PHASED ARRAY COIL PACKAGE K952530 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Jul 1995. https://www.510kdatabase.net/k952132/ 1995-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k952132-sas-brucella-ams-antiserum-fda-510k.jpg K952132 - SAS BRUCELLA AMS ANTISERUM K952132 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Jul 1995. https://www.510kdatabase.net/k952133/ 1995-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k952133-sas-salmonella-o-poly-positive-antiserum-fda-510k.jpg K952133 - SAS SALMONELLA O POLY POSITIVE ANTISERUM K952133 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Jul 1995. https://www.510kdatabase.net/k952134/ 1995-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k952134-sas-salmonella-h-poly-positive-antiserum-fda-510k.jpg K952134 - SAS SALMONELLA H POLY POSITIVE ANTISERUM K952134 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Jul 1995. https://www.510kdatabase.net/k952141/ 1995-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k952141-sas-francisella-tularensis-antiserum-fda-510k.jpg K952141 - SAS FRANCISELLA TULARENSIS ANTISERUM K952141 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Jul 1995. https://www.510kdatabase.net/k952143/ 1995-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k952143-sas-brucella-melitensis-antiserum-fda-510k.jpg K952143 - SAS BRUCELLA MELITENSIS ANTISERUM K952143 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Jul 1995. https://www.510kdatabase.net/k952144/ 1995-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k952144-sas-brucella-suis-antiserum-fda-510k.jpg K952144 - SAS BRUCELLA SUIS ANTISERUM K952144 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Jul 1995. https://www.510kdatabase.net/k952146/ 1995-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k952146-sas-brucellas-abortus-antiserum-fda-510k.jpg K952146 - SAS BRUCELLAS ABORTUS ANTISERUM K952146 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Jul 1995. https://www.510kdatabase.net/k952397/ 1995-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k952397-vitalock-solid-backed-acetabular-shell-fda-510k.jpg K952397 - VITALOCK SOLID BACKED ACETABULAR SHELL K952397 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jul 1995. https://www.510kdatabase.net/k952548/ 1995-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k952548-celsite-venous-system-fda-510k.jpg K952548 - CELSITE VENOUS SYSTEM K952548 is a FDA 510(k) cleared general hospital medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Jul 1995. https://www.510kdatabase.net/k945700/ 1995-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k945700-synthes-usa-anterior-cervical-fda-510k.jpg K945700 - SYNTHES (USA) ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM K945700 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jul 1995. https://www.510kdatabase.net/k951394/ 1995-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k951394-karl-storz-pediatric-vancaillie-manhes-fda-510k.jpg K951394 - KARL STORZ PEDIATRIC VANCAILLIE, MANHES TAKE-APART BIPOLAR FORCEPS, BIPOLAR COAGULATION ELECTRODE K951394 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jul 1995. https://www.510kdatabase.net/k952067/ 1995-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k952067-cordis-steerable-guidewire-fda-510k.jpg K952067 - CORDIS STEERABLE GUIDEWIRE K952067 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Jul 1995. https://www.510kdatabase.net/k952127/ 1995-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k952127-boehringer-mannheim-cholesterol-assay-fda-510k.jpg K952127 - BOEHRINGER MANNHEIM CHOLESTEROL ASSAY K952127 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jul 1995. https://www.510kdatabase.net/k952574/ 1995-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k952574-karl-storz-insulated-grooved-skiked-fda-510k.jpg K952574 - KARL STORZ INSULATED GROOVED, SKIKED, ABLATOR, FIXED BARREL WITH GROOVES, COAGULATING LOOP, DEPTH-LIMITING LOOP ELECTROS K952574 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jul 1995. https://www.510kdatabase.net/k952647/ 1995-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k952647-il-test-lipase-fda-510k.jpg K952647 - IL TEST LIPASE K952647 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jul 1995. https://www.510kdatabase.net/k952786/ 1995-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k952786-triflex-sterile-synthetic-examination-fda-510k.jpg K952786 - TRIFLEX STERILE SYNTHETIC EXAMINATION GLOVES K952786 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jul 1995. https://www.510kdatabase.net/k952079/ 1995-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k952079-imx-digoxin-fda-510k.jpg K952079 - IMX DIGOXIN K952079 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Jul 1995. https://www.510kdatabase.net/k952656/ 1995-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k952656-xxl-balloon-dilatation-catheter-fda-510k.jpg K952656 - XXL BALLOON DILATATION CATHETER K952656 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Jul 1995. https://www.510kdatabase.net/k946034/ 1995-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k946034-quanta-litetm-igg-hrp-fda-510k.jpg K946034 - QUANTA LITE(TM) IGG (HRP) K946034 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Jul 1995. https://www.510kdatabase.net/k946385/ 1995-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k946385-quanta-lite-aca-igm-hrp-fda-510k.jpg K946385 - QUANTA LITE ACA IGM (HRP) K946385 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Jul 1995. https://www.510kdatabase.net/k952139/ 1995-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k952139-sas-brucella-suis-antigen-fda-510k.jpg K952139 - SAS BRUCELLA SUIS ANTIGEN K952139 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Jul 1995. https://www.510kdatabase.net/k952145/ 1995-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k952145-sas-febrile-positive-negative-control-fda-510k.jpg K952145 - SAS FEBRILE POSITIVE & NEGATIVE CONTROL ANTISERUM K952145 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Jul 1995. https://www.510kdatabase.net/k951027/ 1995-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k951027-depuy-amk-co-cr-finned-tibial-tray-fda-510k.jpg K951027 - DEPUY AMK CO-CR FINNED TIBIAL TRAY K951027 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jul 1995. https://www.510kdatabase.net/k951904/ 1995-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k951904-synthes-usa-synthes-point-contact-fda-510k.jpg K951904 - SYNTHES (USA) [SYNTHES] POINT CONTACT FIXATOR PLATE [PC-FIX] K951904 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jul 1995. https://www.510kdatabase.net/k952131/ 1995-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k952131-sas-febrile-antigen-set-fda-510k.jpg K952131 - SAS FEBRILE ANTIGEN SET K952131 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Jul 1995. https://www.510kdatabase.net/k952135/ 1995-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k952135-sas-salmonella-h-d-antigen-fda-510k.jpg K952135 - SAS SALMONELLA H D ANTIGEN K952135 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Jul 1995. https://www.510kdatabase.net/k952136/ 1995-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k952136-sas-salmonella-h-b-antigen-fda-510k.jpg K952136 - SAS SALMONELLA H B ANTIGEN K952136 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Jul 1995. https://www.510kdatabase.net/k952137/ 1995-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k952137-sas-salmonella-h-a-antigen-fda-510k.jpg K952137 - SAS SALMONELLA H A ANTIGEN K952137 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Jul 1995. https://www.510kdatabase.net/k952138/ 1995-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k952138-sas-francisella-tularensis-antigen-fda-510k.jpg K952138 - SAS FRANCISELLA TULARENSIS ANTIGEN K952138 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Jul 1995. https://www.510kdatabase.net/k952140/ 1995-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k952140-sas-brucella-meltiensis-antigen-fda-510k.jpg K952140 - SAS BRUCELLA MELTIENSIS ANTIGEN K952140 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Jul 1995. https://www.510kdatabase.net/k952142/ 1995-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k952142-sas-salmonella-o-group-d-antigen-fda-510k.jpg K952142 - SAS SALMONELLA O GROUP D ANTIGEN K952142 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Jul 1995. https://www.510kdatabase.net/k952147/ 1995-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k952147-sas-brucella-abortus-antigen-fda-510k.jpg K952147 - SAS BRUCELLA ABORTUS ANTIGEN K952147 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Jul 1995. https://www.510kdatabase.net/k952593/ 1995-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k952593-nt-protein-control-syl-m-and-h-fda-510k.jpg K952593 - N/T PROTEIN CONTROL SY/L, M AND H K952593 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Jul 1995. https://www.510kdatabase.net/k952594/ 1995-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k952594-n-protein-standard-sy-fda-510k.jpg K952594 - N PROTEIN STANDARD SY K952594 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Jul 1995. https://www.510kdatabase.net/k944507/ 1995-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k944507-metallic-radial-head-implants-fda-510k.jpg K944507 - METALLIC RADIAL HEAD IMPLANTS K944507 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jul 1995. https://www.510kdatabase.net/k940039/ 1995-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k940039-pellethane-75d-fda-510k.jpg K940039 - PELLETHANE 75D K940039 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jul 1995. https://www.510kdatabase.net/k950595/ 1995-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k950595-luhr-mandibularsmall-fixation-implants-fda-510k.jpg K950595 - LUHR MANDIBULAR/SMALL FIXATION IMPLANTS K950595 is a FDA 510(k) cleared dental medical device. Manufacturer: Howmedica Corp.. Cleared Jul 1995. https://www.510kdatabase.net/k950962/ 1995-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k950962-karl-storz-hok-needle-holders-forceps-fda-510k.jpg K950962 - KARL STORZ HOK NEEDLE HOLDERS, FORCEPS FOR SUTURING, SUTURE SCISSORS, TISSUE PROBES, INJECTION NEEDLE, IRRIGATION INSTRT K950962 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jul 1995. https://www.510kdatabase.net/k942263/ 1995-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k942263-millergalante-precoat-unicompartmental-fda-510k.jpg K942263 - MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE SYSTEM K942263 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jul 1995. https://www.510kdatabase.net/k946150/ 1995-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k946150-cruciate-retaining-augmentable-and-fda-510k.jpg K946150 - CRUCIATE RETAINING (AUGMENTABLE) AND CONSTRAINED CONDYLAR KNEE (CCK) K946150 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jul 1995. https://www.510kdatabase.net/k946274/ 1995-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k946274-columnmate-ii-ghb-affinity-regenerable-fda-510k.jpg K946274 - COLUMNMATE II GHB AFFINITY REGENERABLE COLUMN K946274 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Jul 1995. https://www.510kdatabase.net/k946347/ 1995-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k946347-absorbable-acetabular-screw-fda-510k.jpg K946347 - ABSORBABLE ACETABULAR SCREW K946347 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jul 1995. https://www.510kdatabase.net/k951655/ 1995-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k951655-duracon-recessed-patella-fda-510k.jpg K951655 - DURACON RECESSED PATELLA K951655 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jul 1995. https://www.510kdatabase.net/k951930/ 1995-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k951930-cementralizer-distal-stem-centralizer-fda-510k.jpg K951930 - CEMENTRALIZER DISTAL STEM CENTRALIZER K951930 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jul 1995. https://www.510kdatabase.net/k952814/ 1995-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k952814-ethicon-arthroscopic-knot-pusher-fda-510k.jpg K952814 - ETHICON ARTHROSCOPIC KNOT PUSHER K952814 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Jul 1995. https://www.510kdatabase.net/k945942/ 1995-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k945942-auto-syringer-as50-infusion-pump-fda-510k.jpg K945942 - AUTO SYRINGE(R) AS50 INFUSION PUMP K945942 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jul 1995. https://www.510kdatabase.net/k950833/ 1995-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k950833-depuy-set-screw-fda-510k.jpg K950833 - DEPUY SET SCREW K950833 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jul 1995. https://www.510kdatabase.net/k952351/ 1995-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k952351-precise-denture-base-resin-fda-510k.jpg K952351 - PRECISE DENTURE BASE RESIN K952351 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jul 1995. https://www.510kdatabase.net/k951118/ 1995-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k951118-3m-maxi-driver-ii-electric-system-fda-510k.jpg K951118 - 3M MAXI-DRIVER II ELECTRIC SYSTEM K951118 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3M Company. Cleared Jul 1995. https://www.510kdatabase.net/k951524/ 1995-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k951524-thoracentesis-catheter-fda-510k.jpg K951524 - THORACENTESIS CATHETER K951524 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jul 1995. https://www.510kdatabase.net/k952161/ 1995-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k952161-bipolar-coagulation-instrument-fda-510k.jpg K952161 - BIPOLAR COAGULATION INSTRUMENT K952161 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jul 1995. https://www.510kdatabase.net/k952425/ 1995-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k952425-olympus-apolipoprotein-a1-fda-510k.jpg K952425 - OLYMPUS APOLIPOPROTEIN A1 IMMUNOTURBIDIMETRIC REAGENT K952425 is a FDA 510(k) cleared immunology medical device. Manufacturer: Olympus America, Inc.. Cleared Jul 1995. https://www.510kdatabase.net/k943806/ 1995-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k943806-harpoon-suture-anchors-fda-510k.jpg K943806 - HARPOON SUTURE ANCHORS K943806 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jul 1995. https://www.510kdatabase.net/k951144/ 1995-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k951144-phoenix-plus-base-nuclear-medicine-fda-510k.jpg K951144 - PHOENIX PLUS & BASE NUCLEAR MEDICINE SINGLE DETECTOR SYSTEMS K951144 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Jul 1995. https://www.510kdatabase.net/k951434/ 1995-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k951434-opus-procainamide-fda-510k.jpg K951434 - OPUS PROCAINAMIDE K951434 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Jul 1995. https://www.510kdatabase.net/k952081/ 1995-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k952081-karl-storz-catheters-adaptors-fda-510k.jpg K952081 - KARL STORZ CATHETERS, ADAPTORS, SUCTION/IRRIGATION CATHETERS, TUBING K952081 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jul 1995. https://www.510kdatabase.net/k952418/ 1995-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k952418-v40-zirconia-femoral-heads-fda-510k.jpg K952418 - V40 ZIRCONIA FEMORAL HEADS K952418 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jul 1995. https://www.510kdatabase.net/k952088/ 1995-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k952088-zirconia-articuleze-femoral-balls-fda-510k.jpg K952088 - ZIRCONIA ARTICUL/EZE FEMORAL BALLS K952088 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jun 1995. https://www.510kdatabase.net/k933934/ 1995-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k933934-glucose-6-phosphate-dehydrogenase-fda-510k.jpg K933934 - GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-A K933934 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Jun 1995. https://www.510kdatabase.net/k944007/ 1995-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k944007-europhilic-slippery-coated-foley-fda-510k.jpg K944007 - EUROPHILIC SLIPPERY COATED FOLEY CATHETER K944007 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jun 1995. https://www.510kdatabase.net/k951964/ 1995-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k951964-synchron-enzyme-validator-set-fda-510k.jpg K951964 - SYNCHRON ENZYME VALIDATOR SET K951964 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jun 1995. https://www.510kdatabase.net/k952148/ 1995-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k952148-axsym-ultrasensitive-htsh-ii-fda-510k.jpg K952148 - AXSYM ULTRASENSITIVE HTSH II K952148 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1995. https://www.510kdatabase.net/k952524/ 1995-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k952524-aesculap-biopolar-coagulator-fda-510k.jpg K952524 - AESCULAP BIOPOLAR COAGULATOR K952524 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Jun 1995. https://www.510kdatabase.net/k945626/ 1995-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k945626-quinton-model-710-stress-fda-510k.jpg K945626 - QUINTON MODEL 710 STRESS ELECTROCARDIOGRAPH K945626 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Jun 1995. https://www.510kdatabase.net/k950995/ 1995-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k950995-sensicare-synthetic-surgical-glove-liner-fda-510k.jpg K950995 - SENSICARE SYNTHETIC, SURGICAL GLOVE LINER K950995 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jun 1995. https://www.510kdatabase.net/k946306/ 1995-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k946306-siemens-sc-9000-bedside-monitor-sc-fda-510k.jpg K946306 - SIEMENS SC 9000 BEDSIDE MONITOR, SC 9015 BEDSIDE MOINTORING SYSTEM K946306 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 1995. https://www.510kdatabase.net/k915402/ 1995-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k915402-ew-10-and-ew-20-fda-510k.jpg K915402 - EW-10 AND EW-20 K915402 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Olympus Corp.. Cleared Jun 1995. https://www.510kdatabase.net/k952484/ 1995-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k952484-modem-transfer-application-software-fda-510k.jpg K952484 - MODEM TRANSFER APPLICATION SOFTWARE NSMD-001A & NSMD-070A K952484 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Jun 1995. https://www.510kdatabase.net/k951248/ 1995-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k951248-braun-pta-balloon-catheter-fda-510k.jpg K951248 - BRAUN PTA BALLOON CATHETER K951248 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Jun 1995. https://www.510kdatabase.net/k951307/ 1995-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k951307-baxter-trek-14-intermediate-and-fda-510k.jpg K951307 - BAXTER TREK *14 INTERMEDIATE AND SUPPORT GUIDEWIRES K951307 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jun 1995. https://www.510kdatabase.net/k951415/ 1995-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k951415-luhr-pan-fixation-system-condensed-fda-510k.jpg K951415 - LUHR PAN FIXATION SYSTEM CONDENSED STRAIGHT PLATE, Y PLATES AND 1.5MM BONE SCREW K951415 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jun 1995. https://www.510kdatabase.net/k951508/ 1995-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k951508-stainless-steel-greenfield-vena-cava-fda-510k.jpg K951508 - STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 24F INTRODUCER SYSTEM K951508 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Jun 1995. https://www.510kdatabase.net/k951607/ 1995-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k951607-sureflex-files-fda-510k.jpg K951607 - SUREFLEX FILES K951607 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jun 1995. https://www.510kdatabase.net/k952071/ 1995-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k952071-ultec-thin-hydrocolloid-dressing-fda-510k.jpg K952071 - ULTEC THIN HYDROCOLLOID DRESSING K952071 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sherwood Medical Co.. Cleared Jun 1995. https://www.510kdatabase.net/k941473/ 1995-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k941473-maxima-plus-hollow-fiber-oxygenator-fda-510k.jpg K941473 - MAXIMA PLUS HOLLOW FIBER OXYGENATOR K941473 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jun 1995. https://www.510kdatabase.net/k942391/ 1995-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k942391-braun-manifold-fda-510k.jpg K942391 - BRAUN MANIFOLD K942391 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Jun 1995. https://www.510kdatabase.net/k945666/ 1995-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k945666-evolutiontm-microcatheter-fda-510k.jpg K945666 - EVOLUTION(TM) MICROCATHETER K945666 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Jun 1995. https://www.510kdatabase.net/k952403/ 1995-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k952403-aurolite-80-fda-510k.jpg K952403 - AUROLITE 80 K952403 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jun 1995. https://www.510kdatabase.net/k930353/ 1995-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k930353-simmons-plating-system-bolt-and-screw-fda-510k.jpg K930353 - SIMMONS PLATING SYSTEM BOLT AND SCREW K930353 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jun 1995. https://www.510kdatabase.net/k952309/ 1995-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k952309-n-latex-iga-fda-510k.jpg K952309 - N LATEX IGA K952309 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Jun 1995. https://www.510kdatabase.net/k941666/ 1995-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k941666-signa-advantage-magnetic-resonance-fda-510k.jpg K941666 - SIGNA ADVANTAGE MAGNETIC RESONANCE SYSTEM-HISPEED PERFORMANCE OPTIONS K941666 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jun 1995. https://www.510kdatabase.net/k950639/ 1995-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k950639-karl-storz-infant-balloon-vaginoscope-fda-510k.jpg K950639 - KARL STORZ INFANT, BALLOON VAGINOSCOPE, VAGINOSCOPE SHEATH, FIBER OPTIC LIGHT CARRIERS, ADJUSTABLE MAGNIFIERS K950639 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jun 1995. https://www.510kdatabase.net/k950521/ 1995-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k950521-osteonics-all-polyethylene-glenoid-fda-510k.jpg K950521 - OSTEONICS ALL POLYETHYLENE GLENOID SHOULDER COMPONENT K950521 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Jun 1995. https://www.510kdatabase.net/k951114/ 1995-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k951114-system-12-p1-26mm-acetabular-insert-fda-510k.jpg K951114 - SYSTEM 12 P1 26MM ACETABULAR INSERT K951114 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jun 1995. https://www.510kdatabase.net/k951115/ 1995-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k951115-howmedica-vitalock-22mm-acertabular-fda-510k.jpg K951115 - HOWMEDICA VITALOCK 22MM ACERTABULAR SHELL AND SYSTEM 12 INSERTS K951115 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jun 1995. https://www.510kdatabase.net/k951304/ 1995-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k951304-synthes-27-mm-cannulated-screw-and-fda-510k.jpg K951304 - SYNTHES 2.7 MM CANNULATED SCREW AND THREADED WASHER K951304 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jun 1995. https://www.510kdatabase.net/k952402/ 1995-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k952402-aurium-68m-fda-510k.jpg K952402 - AURIUM 68M K952402 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jun 1995. https://www.510kdatabase.net/k912035/ 1995-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k912035-stainless-steel-green-vena-cava-filt-fda-510k.jpg K912035 - STAINLESS STEEL GREEN VENA CAVA FILT W/12F INTR SY K912035 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Jun 1995. https://www.510kdatabase.net/k945427/ 1995-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k945427-b-d-digital-thermometer-fda-510k.jpg K945427 - B-D DIGITAL THERMOMETER K945427 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jun 1995. https://www.510kdatabase.net/k946271/ 1995-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k946271-vicryo-polyglactin-910-braided-coated-fda-510k.jpg K946271 - VICRYO* (POLYGLACTIN 910) BRAIDED COATED AND UNCOATED SYNTHETIC ABSORBABLE SUTURE, DYED & UNDYED, BRAIDED AND MONOFILAMT K946271 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Jun 1995. https://www.510kdatabase.net/k950418/ 1995-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k950418-alpha-porous-coated-femoral-component-fda-510k.jpg K950418 - ALPHA POROUS COATED FEMORAL COMPONENT (SUBJECT TO WMTI MARKETING APPROVAL) K950418 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jun 1995. https://www.510kdatabase.net/k952149/ 1995-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k952149-karl-storz-take-apart-rotating-fda-510k.jpg K952149 - KARL STORZ TAKE-APART ROTATING GRASPING FORCEPS K952149 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jun 1995. https://www.510kdatabase.net/k951190/ 1995-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k951190-karl-storz-puncture-injection-fda-510k.jpg K951190 - KARL STORZ PUNCTURE, INJECTION, ENDOSCOPIC, VERESS NEEDLE K951190 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jun 1995. https://www.510kdatabase.net/k951354/ 1995-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k951354-olympus-arthroscopy-system-fda-510k.jpg K951354 - OLYMPUS ARTHROSCOPY SYSTEM K951354 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Olympus America, Inc.. Cleared Jun 1995. https://www.510kdatabase.net/k942927/ 1995-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k942927-0035-in-wise-wire-fda-510k.jpg K942927 - 0.035 IN. WISE WIRE K942927 is a FDA 510(k) cleared radiology medical device. Manufacturer: Boston Scientific Corp. Cleared Jun 1995. https://www.510kdatabase.net/k944017/ 1995-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k944017-olympus-laparoscopic-ultrasound-system-fda-510k.jpg K944017 - OLYMPUS LAPAROSCOPIC ULTRASOUND SYSTEM K944017 is a FDA 510(k) cleared radiology medical device. Manufacturer: Olympus America, Inc.. Cleared Jun 1995. https://www.510kdatabase.net/k944912/ 1995-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k944912-olympus-nbd-tubes-fda-510k.jpg K944912 - OLYMPUS NBD TUBES K944912 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus America, Inc.. Cleared Jun 1995. https://www.510kdatabase.net/k944979/ 1995-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k944979-magnetic-resonance-diagnostic-accessory-fda-510k.jpg K944979 - MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY K944979 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Jun 1995. https://www.510kdatabase.net/k945787/ 1995-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k945787-karl-storz-semi-rigid-micro-endoscopes-fda-510k.jpg K945787 - KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ENDOSCOPIC ARTHROSCOPY PROCEDURES K945787 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jun 1995. https://www.510kdatabase.net/k951189/ 1995-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k951189-synchron-cx4cecx5cecx7-clinical-fda-510k.jpg K951189 - SYNCHRON CX4CE/CX5CE/CX7 CLINICAL SYSTEMS SOFTWARE UPDATE VERSION 4.0 K951189 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jun 1995. https://www.510kdatabase.net/k945137/ 1995-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k945137-luhr-titanium-alloy-pan-fixation-system-fda-510k.jpg K945137 - LUHR TITANIUM ALLOY PAN FIXATION SYSTEM K945137 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jun 1995. https://www.510kdatabase.net/k945139/ 1995-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k945139-luhr-titanium-pan-fixation-system-fda-510k.jpg K945139 - LUHR TITANIUM PAN FIXATION SYSTEM K945139 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jun 1995. https://www.510kdatabase.net/k936285/ 1995-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k936285-abbott-vision-glycated-hb-modification-fda-510k.jpg K936285 - ABBOTT VISION GLYCATED HB, MODIFICATION K936285 is a FDA 510(k) cleared hematology medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1995. https://www.510kdatabase.net/k945566/ 1995-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k945566-abbott-project-i-spectrum-fda-510k.jpg K945566 - ABBOTT PROJECT I, SPECTRUM K945566 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1995. https://www.510kdatabase.net/k945891/ 1995-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k945891-karl-storz-knives-curetts-hooks-probes-fda-510k.jpg K945891 - KARL STORZ KNIVES, CURETTS, HOOKS, PROBES K945891 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jun 1995. https://www.510kdatabase.net/k951069/ 1995-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k951069-sas-salmonella-h-b-antiserum-fda-510k.jpg K951069 - SAS SALMONELLA H B ANTISERUM K951069 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Jun 1995. https://www.510kdatabase.net/k951391/ 1995-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k951391-il-test-digoxin-pn-181761-00-fda-510k.jpg K951391 - IL TEST DIGOXIN, PN 181761-00 K951391 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jun 1995. https://www.510kdatabase.net/k951986/ 1995-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k951986-insulated-electrosurgical-instruments-fda-510k.jpg K951986 - INSULATED ELECTROSURGICAL INSTRUMENTS K951986 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jun 1995. https://www.510kdatabase.net/k952192/ 1995-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k952192-karl-storz-unidrive-shaver-arthroscopy-fda-510k.jpg K952192 - KARL STORZ UNIDRIVE SHAVER, ARTHROSCOPY BLADES K952192 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jun 1995. https://www.510kdatabase.net/k940715/ 1995-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k940715-osteonics-omnifit-ad-hip-stem-series-fda-510k.jpg K940715 - OSTEONICS OMNIFIT AD HIP STEM SERIES K940715 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Jun 1995. https://www.510kdatabase.net/k950563/ 1995-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k950563-ultima-augmented-uhmwpe-cup-fda-510k.jpg K950563 - ULTIMA AUGMENTED UHMWPE CUP K950563 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jun 1995. https://www.510kdatabase.net/k941366/ 1995-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k941366-osteonics-omnifit-ad-ha-hip-stem-series-fda-510k.jpg K941366 - OSTEONICS OMNIFIT AD-HA HIP STEM SERIES K941366 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Jun 1995. https://www.510kdatabase.net/k945379/ 1995-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k945379-platinum-plus-guidewire-with-fda-510k.jpg K945379 - PLATINUM PLUS GUIDEWIRE WITH HYDROPHILIC COATING K945379 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Jun 1995. https://www.510kdatabase.net/k946085/ 1995-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k946085-thin-film-cardiac-gating-cable-fda-510k.jpg K946085 - THIN-FILM CARDIAC GATING CABLE K946085 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jun 1995. https://www.510kdatabase.net/k946332/ 1995-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k946332-karl-storz-micro-instrument-for-fda-510k.jpg K946332 - KARL STORZ MICRO-INSTRUMENT FOR COCHLEAR IMPLANTATION K946332 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jun 1995. https://www.510kdatabase.net/k951804/ 1995-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k951804-karl-storz-subglottiscope-neonate-and-fda-510k.jpg K951804 - KARL STORZ SUBGLOTTISCOPE, NEONATE AND INFANT, FIBER OPTIC LIGHT CARRIER, SUCTION TUBE K951804 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jun 1995. https://www.510kdatabase.net/k952466/ 1995-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k952466-olympus-apolipoprotein-b-fda-510k.jpg K952466 - OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIMETRIC REAGENT K952466 is a FDA 510(k) cleared immunology medical device. Manufacturer: Olympus America, Inc.. Cleared Jun 1995. https://www.510kdatabase.net/k942170/ 1995-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k942170-model-511-infant-monitor-fda-510k.jpg K942170 - MODEL 511 INFANT MONITOR K942170 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Jun 1995. https://www.510kdatabase.net/k945674/ 1995-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k945674-mandibular-bone-distractor-fda-510k.jpg K945674 - MANDIBULAR BONE DISTRACTOR K945674 is a FDA 510(k) cleared dental medical device. Manufacturer: Howmedica Corp.. Cleared Jun 1995. https://www.510kdatabase.net/k951058/ 1995-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k951058-glucometer-encore-qa-blood-glucose-fda-510k.jpg K951058 - GLUCOMETER ENCORE QA+ BLOOD GLUCOSE METER WORKSTATION K951058 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Jun 1995. https://www.510kdatabase.net/k951163/ 1995-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k951163-gore-smoother-guided-rasp-fda-510k.jpg K951163 - GORE SMOOTHER GUIDED RASP K951163 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Jun 1995. https://www.510kdatabase.net/k951319/ 1995-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k951319-roche-abuscreen-online-for-opiates-fda-510k.jpg K951319 - ROCHE ABUSCREEN ONLINE FOR OPIATES 1000 TEST KIT-2000 NG/ML CUTOFF OLYMPUS AU800 INSTRUMENT APPLICATION K951319 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jun 1995. https://www.510kdatabase.net/k951441/ 1995-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k951441-dupont-aca-digoxin-dgn-a-method-fda-510k.jpg K951441 - DUPONT ACA DIGOXIN (DGN A) METHOD K951441 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Jun 1995. https://www.510kdatabase.net/k951755/ 1995-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k951755-emit-2000-digoxin-assay-fda-510k.jpg K951755 - EMIT 2000 DIGOXIN ASSAY K951755 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Jun 1995. https://www.510kdatabase.net/k943908/ 1995-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k943908-infinity-shoulder-system-fda-510k.jpg K943908 - INFINITY SHOULDER SYSTEM K943908 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared May 1995. https://www.510kdatabase.net/k943950/ 1995-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k943950-ethicon-nonabsorbable-suture-anchor-fda-510k.jpg K943950 - ETHICON NONABSORBABLE SUTURE ANCHOR K943950 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ethicon, Inc.. Cleared May 1995. https://www.510kdatabase.net/k945574/ 1995-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k945574-osteonicsr-ccr-hip-stem-series-fda-510k.jpg K945574 - OSTEONICS(R) CCR HIP STEM SERIES K945574 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared May 1995. https://www.510kdatabase.net/k950929/ 1995-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k950929-sensi-touch-epidural-anesthesia-tray-fda-510k.jpg K950929 - SENSI-TOUCH EPIDURAL ANESTHESIA TRAY K950929 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sherwood Medical Co.. Cleared May 1995. https://www.510kdatabase.net/k941282/ 1995-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k941282-ecg-fax-modem-fda-510k.jpg K941282 - ECG FAX MODEM K941282 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared May 1995. https://www.510kdatabase.net/k944083/ 1995-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k944083-monojectr-sampletter-collection-tube-fda-510k.jpg K944083 - MONOJECT(R) SAMPLETTE(R) COLLECTION TUBE K944083 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sherwood Medical Co.. Cleared May 1995. https://www.510kdatabase.net/k945844/ 1995-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k945844-depuy-cdh-prosthesis-fda-510k.jpg K945844 - DEPUY CDH PROSTHESIS K945844 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared May 1995. https://www.510kdatabase.net/k946147/ 1995-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k946147-kse-steiner-electromechanic-morcellator-fda-510k.jpg K946147 - KSE STEINER ELECTROMECHANIC MORCELLATOR K946147 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared May 1995. https://www.510kdatabase.net/k950961/ 1995-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k950961-ksea-disposable-tubing-sets-for-the-fda-510k.jpg K950961 - KSEA DISPOSABLE TUBING SETS FOR THE HAMOU ENDOMAT PUMP K950961 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared May 1995. https://www.510kdatabase.net/k934939/ 1995-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k934939-temporary-screening-lead-catheter-kit-fda-510k.jpg K934939 - TEMPORARY SCREENING LEAD/ CATHETER KIT K934939 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medtronic Vascular. Cleared May 1995. https://www.510kdatabase.net/k935877/ 1995-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k935877-nihon-kohden-central-nurse-station-cns-fda-510k.jpg K935877 - NIHON KOHDEN CENTRAL NURSE STATION, CNS-8310A/CNS-8350A K935877 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared May 1995. https://www.510kdatabase.net/k944422/ 1995-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k944422-bsm-8800a-bedside-monitor-fda-510k.jpg K944422 - BSM-8800A BEDSIDE MONITOR K944422 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared May 1995. https://www.510kdatabase.net/k945413/ 1995-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k945413-medtronic-model-3864c-3865c-temporary-fda-510k.jpg K945413 - MEDTRONIC MODEL 3864C & 3865C TEMPORARY SCREENING LEAD/CATHETER KIT K945413 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medtronic Vascular. Cleared May 1995. https://www.510kdatabase.net/k946081/ 1995-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k946081-fluorex-dta-400a-fda-510k.jpg K946081 - FLUOREX DTA-400A K946081 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared May 1995. https://www.510kdatabase.net/k940179/ 1995-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k940179-arthroscope-for-small-joint-after-fda-510k.jpg K940179 - ARTHROSCOPE FOR SMALL JOINT AFTER FELDKAMP, MODEL 8871.011 K940179 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared May 1995. https://www.510kdatabase.net/k944190/ 1995-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k944190-lifecare-175-infuser-modification-fda-510k.jpg K944190 - LIFECARE 175 INFUSER, MODIFICATION K944190 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared May 1995. https://www.510kdatabase.net/k951476/ 1995-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k951476-e-pack-procedure-kits-fda-510k.jpg K951476 - E-PACK PROCEDURE KITS K951476 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared May 1995. https://www.510kdatabase.net/k951515/ 1995-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k951515-monoject-vertical-entry-chemotherapy-fda-510k.jpg K951515 - MONOJECT VERTICAL ENTRY CHEMOTHERAPY SHARPS CONTAINER K951515 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared May 1995. https://www.510kdatabase.net/k951864/ 1995-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k951864-prime-bond-direct-composite-bonding-fda-510k.jpg K951864 - PRIME & BOND DIRECT COMPOSITE BONDING AGENT K951864 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared May 1995. https://www.510kdatabase.net/k944678/ 1995-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k944678-nihon-kohden-electroencephalograph-fda-510k.jpg K944678 - NIHON KOHDEN ELECTROENCEPHALOGRAPH K944678 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared May 1995. https://www.510kdatabase.net/k950384/ 1995-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k950384-synthesusa-synthes-hybrid-external-fda-510k.jpg K950384 - SYNTHES(USA) SYNTHES HYBRID EXTERNAL FIXATOR K950384 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared May 1995. https://www.510kdatabase.net/k950483/ 1995-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k950483-hewlett-packard-m2475b-codemaster-100-fda-510k.jpg K950483 - HEWLETT PACKARD M2475B CODEMASTER 100 DEFIBRILLATOR/MONITOR K950483 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared May 1995. https://www.510kdatabase.net/k951253/ 1995-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k951253-axsym-barbiturates-ii-u-fda-510k.jpg K951253 - AXSYM BARBITURATES II U K951253 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared May 1995. https://www.510kdatabase.net/k951287/ 1995-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k951287-axsym-opiates-fda-510k.jpg K951287 - AXSYM OPIATES K951287 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared May 1995. https://www.510kdatabase.net/k951492/ 1995-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k951492-rib-resector-fda-510k.jpg K951492 - RIB RESECTOR K951492 is a FDA 510(k) cleared neurology medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared May 1995. https://www.510kdatabase.net/k943696/ 1995-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k943696-all-polyethylene-cemented-acetabular-cup-fda-510k.jpg K943696 - ALL POLYETHYLENE CEMENTED ACETABULAR CUP K943696 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared May 1995. https://www.510kdatabase.net/k944592/ 1995-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k944592-precision-osteolock-femoral-component-fda-510k.jpg K944592 - PRECISION OSTEOLOCK FEMORAL COMPONENT K944592 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared May 1995. https://www.510kdatabase.net/k950119/ 1995-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k950119-opta-5tm-5f-pta-balloon-catheter-fda-510k.jpg K950119 - OPTA 5(TM) 5F PTA BALLOON CATHETER K950119 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared May 1995. https://www.510kdatabase.net/k950312/ 1995-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k950312-alpha-system-fda-510k.jpg K950312 - ALPHA SYSTEM K950312 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared May 1995. https://www.510kdatabase.net/k951309/ 1995-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k951309-stone-dislodger-basket-fda-510k.jpg K951309 - STONE DISLODGER, BASKET K951309 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared May 1995. https://www.510kdatabase.net/k951629/ 1995-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k951629-imx-estradiol-fda-510k.jpg K951629 - IMX ESTRADIOL K951629 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared May 1995. https://www.510kdatabase.net/k933077/ 1995-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k933077-exeter-intramedullary-bone-plug-fda-510k.jpg K933077 - EXETER INTRAMEDULLARY BONE PLUG K933077 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared May 1995. https://www.510kdatabase.net/k944856/ 1995-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k944856-orthomet-acetabular-roof-reinforcement-fda-510k.jpg K944856 - ORTHOMET ACETABULAR ROOF REINFORCEMENT RING K944856 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared May 1995. https://www.510kdatabase.net/k945651/ 1995-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k945651-liquichektm-immunology-control-levels-fda-510k.jpg K945651 - LIQUICHEK(TM IMMUNOLOGY CONTROL, LEVELS 1.2. AND 3 K945651 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared May 1995. https://www.510kdatabase.net/k950915/ 1995-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k950915-abbott-axsym-ii-system-fda-510k.jpg K950915 - ABBOTT AXSYM II SYSTEM K950915 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared May 1995. https://www.510kdatabase.net/k951286/ 1995-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k951286-axsym-benzodiazepines-fda-510k.jpg K951286 - AXSYM BENZODIAZEPINES K951286 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared May 1995. https://www.510kdatabase.net/k951288/ 1995-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k951288-axsym-cannabinoids-fda-510k.jpg K951288 - AXSYM CANNABINOIDS K951288 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared May 1995. https://www.510kdatabase.net/k951625/ 1995-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k951625-karl-storz-koh-needle-holders-forceps-fda-510k.jpg K951625 - KARL STORZ KOH NEEDLE HOLDERS, FORCEPS FOR SUTURING, SUTURE SCISSORS, TISSUE PROBES, INJECTION NEEDLE, IRRIGATION INSTRT K951625 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared May 1995. https://www.510kdatabase.net/k951860/ 1995-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k951860-howmedice-bone-plug-fda-510k.jpg K951860 - HOWMEDICE BONE PLUG K951860 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared May 1995. https://www.510kdatabase.net/k951934/ 1995-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k951934-pfc-cement-restrictor-fda-510k.jpg K951934 - PFC CEMENT RESTRICTOR K951934 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared May 1995. https://www.510kdatabase.net/k943686/ 1995-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k943686-il-test-beta-2microglobulin-fda-510k.jpg K943686 - IL TEST BETA-2MICROGLOBULIN K943686 is a FDA 510(k) cleared immunology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared May 1995. https://www.510kdatabase.net/k946228/ 1995-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k946228-cross-pin-screw-system-fda-510k.jpg K946228 - CROSS PIN SCREW SYSTEM K946228 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared May 1995. https://www.510kdatabase.net/k950010/ 1995-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k950010-darwin-knee-system-cruciate-fda-510k.jpg K950010 - DARWIN KNEE SYSTEM (CRUCIATE SUBSTITUTING) POROUS COATED AND NON-POROUS COATED K950010 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared May 1995. https://www.510kdatabase.net/k950202/ 1995-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k950202-ringloc-constrained-liner-fda-510k.jpg K950202 - RINGLOC CONSTRAINED LINER K950202 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared May 1995. https://www.510kdatabase.net/k950751/ 1995-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k950751-tecothane-75d-polyurethane-resin-for-fda-510k.jpg K950751 - TECOTHANE 75D POLYURETHANE RESIN FOR PULSE GENERATOR CONNECTOR MODULES K950751 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared May 1995. https://www.510kdatabase.net/k951358/ 1995-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k951358-sireskop-sx-fda-510k.jpg K951358 - SIRESKOP SX K951358 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 1995. https://www.510kdatabase.net/k951396/ 1995-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k951396-kodak-x-omat-3000-ra-processor-fda-510k.jpg K951396 - KODAK X-OMAT 3000 RA PROCESSOR K951396 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared May 1995. https://www.510kdatabase.net/k951397/ 1995-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k951397-kodak-x-omat-5000-ra-processor-fda-510k.jpg K951397 - KODAK X-OMAT 5000 RA PROCESSOR K951397 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared May 1995. https://www.510kdatabase.net/k951635/ 1995-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k951635-beckman-immunoglobulin-g-igg-reagent-fda-510k.jpg K951635 - BECKMAN IMMUNOGLOBULIN G (IGG) REAGENT, URINE APPLICATION, URINE PROTEIN CALIBRATOR, CONTROL K951635 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared May 1995. https://www.510kdatabase.net/k951748/ 1995-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k951748-coat-a-count-lh-irma-fda-510k.jpg K951748 - COAT-A-COUNT LH IRMA K951748 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared May 1995. https://www.510kdatabase.net/k951826/ 1995-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k951826-karl-storz-tracheal-high-frequency-fda-510k.jpg K951826 - KARL STORZ TRACHEAL HIGH FREQUENCY RESECTOSCOPE K951826 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared May 1995. https://www.510kdatabase.net/k945193/ 1995-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k945193-all-in-one-two-chamber-container-fda-510k.jpg K945193 - ALL-IN-ONE TWO CHAMBER CONTAINER K945193 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared May 1995. https://www.510kdatabase.net/k945907/ 1995-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k945907-karl-storz-semi-rigid-micro-endoscopes-fda-510k.jpg K945907 - KARL STORZ SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ADULT AND PEDIATRIC ENDOSCOPIC UROLOGY PROCEDURES K945907 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared May 1995. https://www.510kdatabase.net/k950561/ 1995-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k950561-ksea-disposable-tubing-set-for-the-fda-510k.jpg K950561 - KSEA DISPOSABLE TUBING SET FOR THE ARTHROPUMP K950561 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared May 1995. https://www.510kdatabase.net/k951715/ 1995-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k951715-endo-irrigator-2211-including-tubing-fda-510k.jpg K951715 - ENDO IRRIGATOR 2211, INCLUDING TUBING K951715 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared May 1995. https://www.510kdatabase.net/k941191/ 1995-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k941191-real-time-stereotix-fda-510k.jpg K941191 - REAL TIME STEREOTIX K941191 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared May 1995. https://www.510kdatabase.net/k942884/ 1995-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k942884-coaguchek-system-fda-510k.jpg K942884 - COAGUCHEK SYSTEM K942884 is a FDA 510(k) cleared hematology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared May 1995. https://www.510kdatabase.net/k944590/ 1995-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k944590-ethicon-drill-bit-and-drill-guide-fda-510k.jpg K944590 - ETHICON DRILL BIT AND DRILL GUIDE K944590 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ethicon, Inc.. Cleared May 1995. https://www.510kdatabase.net/k946359/ 1995-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k946359-karl-storz-dilation-set-reducers-fda-510k.jpg K946359 - KARL STORZ DILATION SET, REDUCERS, THREAD SLEEVES, DISTANCE HOLDERS K946359 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared May 1995. https://www.510kdatabase.net/k950466/ 1995-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k950466-b-d-ultra-fine-ii-pen-needle-fda-510k.jpg K950466 - B-D ULTRA-FINE II PEN NEEDLE K950466 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared May 1995. https://www.510kdatabase.net/k950973/ 1995-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k950973-magnetic-resonance-diagnostic-system-fda-510k.jpg K950973 - MAGNETIC RESONANCE DIAGNOSTIC SYSTEM K950973 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared May 1995. https://www.510kdatabase.net/k951674/ 1995-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k951674-depuy-duraloc-100c-acetabular-cup-fda-510k.jpg K951674 - DEPUY DURALOC 100C ACETABULAR CUP K951674 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared May 1995. https://www.510kdatabase.net/k942791/ 1995-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k942791-argyle-aqua-seal-continuous-fda-510k.jpg K942791 - ARGYLE AQUA-SEAL CONTINUOUS AUTOTRANSFUSION CHEST DRAINAGE UNIT K942791 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sherwood Medical Co.. Cleared May 1995. https://www.510kdatabase.net/k945384/ 1995-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k945384-1481-t-digital-telemetry-systems-fda-510k.jpg K945384 - 1481 T DIGITAL TELEMETRY SYSTEMS, ENHANCED K945384 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 1995. https://www.510kdatabase.net/k950208/ 1995-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k950208-nihon-kohden-neuropack-sigma-meb-5500a-fda-510k.jpg K950208 - NIHON KOHDEN NEUROPACK SIGMA MEB-5500A EVOKED RESPONSE & EMG MEASURING SYSTEM K950208 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared May 1995. https://www.510kdatabase.net/k946151/ 1995-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k946151-benchmark-series-arthrosccopic-fda-510k.jpg K946151 - BENCHMARK SERIES ARTHROSCCOPIC INSTRUMENTS K946151 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared May 1995. https://www.510kdatabase.net/k950315/ 1995-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k950315-cordis-csf-reservoir-fda-510k.jpg K950315 - CORDIS CSF RESERVOIR K950315 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cordis Corp.. Cleared May 1995. https://www.510kdatabase.net/k950562/ 1995-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k950562-implantable-staple-fda-510k.jpg K950562 - IMPLANTABLE STAPLE K950562 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared May 1995. https://www.510kdatabase.net/k951395/ 1995-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k951395-karl-storz-ent-needles-tonsil-syringes-fda-510k.jpg K951395 - KARL STORZ ENT NEEDLES, TONSIL SYRINGES & NEEDLES K951395 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared May 1995. https://www.510kdatabase.net/k951535/ 1995-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k951535-karl-storz-endoscopes-telescope-holders-fda-510k.jpg K951535 - KARL STORZ ENDOSCOPES, TELESCOPE HOLDERS K951535 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared May 1995. https://www.510kdatabase.net/k945908/ 1995-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k945908-glucose-hk-reagent-procedure-no16-fda-510k.jpg K945908 - GLUCOSE (HK) REAGENT (PROCEDURE NO.16) K945908 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared May 1995. https://www.510kdatabase.net/k950958/ 1995-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k950958-synchon-cx-delta-clin-syst-cx4-cx5-cx7-fda-510k.jpg K950958 - SYNCHON CX DELTA CLIN SYST (CX4, CX5, CX7 DELTA) K950958 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared May 1995. https://www.510kdatabase.net/k945685/ 1995-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k945685-karl-storz-telescope-bridges-and-fda-510k.jpg K945685 - KARL STORZ TELESCOPE BRIDGES AND INSERTS, ADAPTERS K945685 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared May 1995. https://www.510kdatabase.net/k950432/ 1995-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k950432-vacutainer-brand-safety-lok-needle-fda-510k.jpg K950432 - VACUTAINER BRAND SAFETY-LOK NEEDLE HOLDER K950432 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared May 1995. https://www.510kdatabase.net/k951361/ 1995-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k951361-dca-2000-system-for-hemoglobin-a1c-fda-510k.jpg K951361 - DCA 2000 SYSTEM FOR HEMOGLOBIN A1C K951361 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared May 1995. https://www.510kdatabase.net/k951425/ 1995-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k951425-spectrum-curing-light-polymerization-fda-510k.jpg K951425 - SPECTRUM CURING LIGHT POLYMERIZATION UNIT K951425 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared May 1995. https://www.510kdatabase.net/k950502/ 1995-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k950502-ccd-endocam-5501-fda-510k.jpg K950502 - CCD ENDOCAM 5501 K950502 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared May 1995. https://www.510kdatabase.net/k951744/ 1995-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k951744-large-tip-4mm-diagnostic-fda-510k.jpg K951744 - LARGE TIP (4MM) DIAGNOSTIC-ELECTROHYSIOLOGY CATHETERS K951744 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared May 1995. https://www.510kdatabase.net/k925581/ 1995-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k925581-baxter-biostat-1000-urea-monitor-fda-510k.jpg K925581 - BAXTER BIOSTAT 1000 UREA MONITOR K925581 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared May 1995. https://www.510kdatabase.net/k945185/ 1995-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k945185-cystoscope-78fajendoscopefiberoptic-fda-510k.jpg K945185 - CYSTOSCOPE (78FAJ)ENDOSCOPE,FIBEROPTIC (78GDB) K945185 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared May 1995. https://www.510kdatabase.net/k946156/ 1995-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k946156-depuy-compression-hip-screw-system-fda-510k.jpg K946156 - DEPUY COMPRESSION HIP SCREW SYSTEM K946156 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared May 1995. https://www.510kdatabase.net/k951296/ 1995-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k951296-delton-f-pit-fissure-sealant-fda-510k.jpg K951296 - DELTON F PIT & FISSURE SEALANT K951296 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared May 1995. https://www.510kdatabase.net/k951312/ 1995-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k951312-monoject-whitacre-point-spinal-needle-fda-510k.jpg K951312 - MONOJECT WHITACRE POINT SPINAL NEEDLE (27G X 3 1/2) K951312 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sherwood Medical Co.. Cleared May 1995. https://www.510kdatabase.net/k951445/ 1995-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k951445-olympus-fd-5-hot-biopsy-forceps-fda-510k.jpg K951445 - OLYMPUS FD-5 HOT BIOPSY FORCEPS K951445 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus America, Inc.. Cleared May 1995. https://www.510kdatabase.net/k951589/ 1995-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k951589-manual-surgical-insrument-fda-510k.jpg K951589 - MANUAL SURGICAL INSRUMENT K951589 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared May 1995. https://www.510kdatabase.net/k945115/ 1995-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k945115-mallory-head-modular-calcar-repacement-fda-510k.jpg K945115 - MALLORY-HEAD MODULAR CALCAR REPACEMENT COMPONENTS K945115 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared May 1995. https://www.510kdatabase.net/k950280/ 1995-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k950280-tdxrtdxflxr-free-phenytoin-ii-fda-510k.jpg K950280 - TDX(R)/TDXFLX(R) FREE PHENYTOIN II K950280 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared May 1995. https://www.510kdatabase.net/k950761/ 1995-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k950761-index-acetabulat-component-fda-510k.jpg K950761 - INDEX ACETABULAT COMPONENT K950761 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared May 1995. https://www.510kdatabase.net/k936040/ 1995-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k936040-hypor-safety-cartridge-syringe-fda-510k.jpg K936040 - HYPO(R) SAFETY CARTRIDGE SYRINGE K936040 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Smith & Nephew, Inc.. Cleared May 1995. https://www.510kdatabase.net/k943980/ 1995-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k943980-il-test-phenytion-calibrators-fda-510k.jpg K943980 - IL TEST PHENYTION CALIBRATORS K943980 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared May 1995. https://www.510kdatabase.net/k951411/ 1995-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k951411-monoject-tuohy-point-epidural-needle-fda-510k.jpg K951411 - MONOJECT TUOHY POINT EPIDURAL NEEDLE (22G X 3 1/2) K951411 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sherwood Medical Co.. Cleared May 1995. https://www.510kdatabase.net/k950352/ 1995-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k950352-preceder-guidewire-fda-510k.jpg K950352 - PRECEDER GUIDEWIRE K950352 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Apr 1995. https://www.510kdatabase.net/k951103/ 1995-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k951103-silastic-brand-foley-catheter-fda-510k.jpg K951103 - SILASTIC BRAND FOLEY CATHETER K951103 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 1995. https://www.510kdatabase.net/k943623/ 1995-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k943623-pq5000-ct-system-fda-510k.jpg K943623 - PQ5000 CT SYSTEM K943623 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Apr 1995. https://www.510kdatabase.net/k945634/ 1995-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k945634-imxr-toxo-igm-fda-510k.jpg K945634 - IMX(R) TOXO IGM K945634 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1995. https://www.510kdatabase.net/k950300/ 1995-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k950300-bard-flexible-tip-ureteral-catheter-fda-510k.jpg K950300 - BARD FLEXIBLE TIP URETERAL CATHETER K950300 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 1995. https://www.510kdatabase.net/k950454/ 1995-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k950454-cahp-high-performance-cellulose-fda-510k.jpg K950454 - CAHP HIGH PERFORMANCE CELLULOSE DIACETATE HOLLOW FIBER DIALYZER K950454 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Apr 1995. https://www.510kdatabase.net/k950522/ 1995-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k950522-cahp-high-performance-cellulose-fda-510k.jpg K950522 - CAHP HIGH PERFORMANCE CELLULOSE DIACETATE HOLLOW FIBER DIALYZER K950522 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Apr 1995. https://www.510kdatabase.net/k950700/ 1995-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k950700-bard-bilisystem-endoscopic-retrograde-fda-510k.jpg K950700 - BARD BILISYSTEM ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) CANNULA K950700 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 1995. https://www.510kdatabase.net/k951095/ 1995-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k951095-105mm-replica-hip-stem-fda-510k.jpg K951095 - 10.5MM REPLICA HIP STEM K951095 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Apr 1995. https://www.510kdatabase.net/k944792/ 1995-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k944792-zimmer-monobloc-hip-prosthesis-with-fda-510k.jpg K944792 - ZIMMER MONOBLOC HIP PROSTHESIS WITH POLY (METHYL METHACRYLATE) K944792 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Apr 1995. https://www.510kdatabase.net/k945524/ 1995-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k945524-cordis-introducing-catheter-fda-510k.jpg K945524 - CORDIS INTRODUCING CATHETER K945524 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Apr 1995. https://www.510kdatabase.net/k930265/ 1995-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k930265-hydrogen-spectroscopy-option-probe-fda-510k.jpg K930265 - HYDROGEN SPECTROSCOPY OPTION-PROBE #M1040HS/HT K930265 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Apr 1995. https://www.510kdatabase.net/k942730/ 1995-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k942730-aesculap-laparoscopes-fda-510k.jpg K942730 - AESCULAP LAPAROSCOPES K942730 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Aesculap, Inc.. Cleared Apr 1995. https://www.510kdatabase.net/k951252/ 1995-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k951252-karl-storz-pediatric-pyloric-spreader-fda-510k.jpg K951252 - KARL STORZ PEDIATRIC PYLORIC SPREADER, PYLOROTOME, ENDOTOME K951252 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Apr 1995. https://www.510kdatabase.net/k946106/ 1995-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k946106-gore-tex-dualmesh-plus-biomaterial-fda-510k.jpg K946106 - GORE-TEX DUALMESH PLUS BIOMATERIAL K946106 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Apr 1995. https://www.510kdatabase.net/k946107/ 1995-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k946107-gore-tex-mycromesh-plus-biomaterial-fda-510k.jpg K946107 - GORE-TEX MYCROMESH PLUS BIOMATERIAL K946107 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Apr 1995. https://www.510kdatabase.net/k942376/ 1995-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k942376-cobas-core-free-t3-eia-fda-510k.jpg K942376 - COBAS CORE FREE T3 EIA K942376 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Apr 1995. https://www.510kdatabase.net/k951170/ 1995-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k951170-vigil-multichek-controls-fda-510k.jpg K951170 - VIGIL MULTICHEK CONTROLS K951170 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Apr 1995. https://www.510kdatabase.net/k951176/ 1995-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k951176-koordinat-m-fda-510k.jpg K951176 - KOORDINAT M K951176 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 1995. https://www.510kdatabase.net/k951293/ 1995-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k951293-quantitate-enzyme-verifier-set-fda-510k.jpg K951293 - QUANTITATE ENZYME VERIFIER SET K951293 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Apr 1995. https://www.510kdatabase.net/k950425/ 1995-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k950425-tecothane-55d-fda-510k.jpg K950425 - TECOTHANE 55D K950425 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Apr 1995. https://www.510kdatabase.net/k926551/ 1995-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k926551-behring-fibrintimer-a-fda-510k.jpg K926551 - BEHRING FIBRINTIMER A K926551 is a FDA 510(k) cleared hematology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Apr 1995. https://www.510kdatabase.net/k951301/ 1995-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k951301-depuy-duraloc-cementless-acetabular-fda-510k.jpg K951301 - DEPUY DURALOC CEMENTLESS ACETABULAR CUP SYSTEM K951301 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Apr 1995. https://www.510kdatabase.net/k951012/ 1995-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k951012-nt-protein-control-py-fda-510k.jpg K951012 - N/T PROTEIN CONTROL PY K951012 is a FDA 510(k) cleared hematology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Apr 1995. https://www.510kdatabase.net/k951013/ 1995-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k951013-olympus-igg-immunoturbidimetric-reagent-fda-510k.jpg K951013 - OLYMPUS IGG IMMUNOTURBIDIMETRIC REAGENT K951013 is a FDA 510(k) cleared immunology medical device. Manufacturer: Olympus America, Inc.. Cleared Apr 1995. https://www.510kdatabase.net/k951055/ 1995-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k951055-olympus-iga-immunoturbidimetric-reagent-fda-510k.jpg K951055 - OLYMPUS IGA IMMUNOTURBIDIMETRIC REAGENT K951055 is a FDA 510(k) cleared immunology medical device. Manufacturer: Olympus America, Inc.. Cleared Apr 1995. https://www.510kdatabase.net/k941616/ 1995-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k941616-variant-total-ghb-program-fda-510k.jpg K941616 - VARIANT TOTAL GHB PROGRAM K941616 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bio-Rad. Cleared Apr 1995. https://www.510kdatabase.net/k945426/ 1995-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k945426-arthrex-cancellous-screw-and-washer-fda-510k.jpg K945426 - ARTHREX CANCELLOUS SCREW AND WASHER K945426 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Apr 1995. https://www.510kdatabase.net/k945639/ 1995-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k945639-spetzler-pin-fda-510k.jpg K945639 - SPETZLER PIN K945639 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Apr 1995. https://www.510kdatabase.net/k950316/ 1995-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k950316-cordis-steerable-guidewires-fda-510k.jpg K950316 - CORDIS STEERABLE GUIDEWIRES K950316 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Apr 1995. https://www.510kdatabase.net/k943240/ 1995-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k943240-flexiflo-six-enteral-nutrition-pump-set-fda-510k.jpg K943240 - FLEXIFLO SIX ENTERAL NUTRITION PUMP SET K943240 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1995. https://www.510kdatabase.net/k950137/ 1995-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k950137-urine-barbiturates-screen-flextm-fda-510k.jpg K950137 - URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGE K950137 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Apr 1995. https://www.510kdatabase.net/k950540/ 1995-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k950540-implantable-clip-fda-510k.jpg K950540 - IMPLANTABLE CLIP K950540 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Apr 1995. https://www.510kdatabase.net/k943537/ 1995-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k943537-model-3470-x-trel-rf-receiver-fda-510k.jpg K943537 - MODEL 3470 X-TREL RF RECEIVER K943537 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Apr 1995. https://www.510kdatabase.net/k945828/ 1995-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k945828-echo-planar-imaging-i-fda-510k.jpg K945828 - ECHO PLANAR IMAGING I K945828 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Apr 1995. https://www.510kdatabase.net/k946358/ 1995-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k946358-endoscopic-biliary-catheter-fda-510k.jpg K946358 - ENDOSCOPIC BILIARY CATHETER K946358 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Apr 1995. https://www.510kdatabase.net/k933177/ 1995-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k933177-siemens-sirecust-700-bedside-monitor-fda-510k.jpg K933177 - SIEMENS SIRECUST 700 BEDSIDE MONITOR MODIFICATIONS K933177 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 1995. https://www.510kdatabase.net/k943983/ 1995-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k943983-il-test-digoxin-il-test-digoxin-fda-510k.jpg K943983 - IL TEST DIGOXIN & IL TEST DIGOXIN CALIBRATORS K943983 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Apr 1995. https://www.510kdatabase.net/k944350/ 1995-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k944350-sc-6000-sc-6000p-r50-fda-510k.jpg K944350 - SC 6000/ SC 6000P/ R50 K944350 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 1995. https://www.510kdatabase.net/k944610/ 1995-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k944610-olympus-ultrasonic-probes-fda-510k.jpg K944610 - OLYMPUS ULTRASONIC PROBES K944610 is a FDA 510(k) cleared radiology medical device. Manufacturer: Olympus America, Inc.. Cleared Apr 1995. https://www.510kdatabase.net/k944836/ 1995-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k944836-osteonics-restoration-monolithic-ii-fda-510k.jpg K944836 - OSTEONICS RESTORATION MONOLITHIC II HIP STEM SERIES K944836 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Apr 1995. https://www.510kdatabase.net/k945793/ 1995-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k945793-pfcr-bipolar-hip-system-22mm-bipolar-fda-510k.jpg K945793 - P.F.C.(R) BIPOLAR HIP SYSTEM - 22MM BIPOLAR K945793 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Apr 1995. https://www.510kdatabase.net/k946234/ 1995-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k946234-osteonicsr-restoration-monolithic-ii-fda-510k.jpg K946234 - OSTEONICS(R) RESTORATION MONOLITHIC II HIP STEM SERIES K946234 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Apr 1995. https://www.510kdatabase.net/k950105/ 1995-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k950105-luhrr-titanium-alloy-burr-hole-covers-fda-510k.jpg K950105 - LUHR(R) TITANIUM ALLOY BURR HOLE COVERS K950105 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Apr 1995. https://www.510kdatabase.net/k951265/ 1995-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k951265-monoject-diamond-point-spinal-needle-fda-510k.jpg K951265 - MONOJECT DIAMOND POINT SPINAL NEEDLE (28G X 3 1/2) K951265 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sherwood Medical Co.. Cleared Apr 1995. https://www.510kdatabase.net/k940298/ 1995-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k940298-bscca-model-940-iab-fda-510k.jpg K940298 - BSC/CA MODEL 940 IAB K940298 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Apr 1995. https://www.510kdatabase.net/k950339/ 1995-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k950339-ksea-steiner-electromechanic-morcellator-fda-510k.jpg K950339 - KSEA STEINER ELECTROMECHANIC MORCELLATOR K950339 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Apr 1995. https://www.510kdatabase.net/k951053/ 1995-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k951053-angiorex-cat-350b-fda-510k.jpg K951053 - ANGIOREX CAT-350B K951053 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Apr 1995. https://www.510kdatabase.net/k951201/ 1995-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k951201-karl-storz-nasal-tonsil-ear-laryngeal-fda-510k.jpg K951201 - KARL STORZ NASAL,, TONSIL, EAR, LARYNGEAL SNARE K951201 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Apr 1995. https://www.510kdatabase.net/k933200/ 1995-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k933200-olympus-pbd-stents-fda-510k.jpg K933200 - OLYMPUS PBD STENTS K933200 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Corp.. Cleared Apr 1995. https://www.510kdatabase.net/k945187/ 1995-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k945187-roche-abuscreen-online-for-methaqualone-fda-510k.jpg K945187 - ROCHE ABUSCREEN ONLINE FOR METHAQUALONE K945187 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Apr 1995. https://www.510kdatabase.net/k950136/ 1995-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k950136-urine-opiates-screen-flextm-reagent-fda-510k.jpg K950136 - URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE K950136 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Apr 1995. https://www.510kdatabase.net/k950181/ 1995-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k950181-urine-cannabinoids-screen-flextm-fda-510k.jpg K950181 - URINE CANNABINOIDS SCREEN FLEX(TM) REAGENT CARTRIDGE K950181 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Apr 1995. https://www.510kdatabase.net/k950282/ 1995-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k950282-karl-storz-modified-veress-needle-and-fda-510k.jpg K950282 - KARL STORZ MODIFIED VERESS NEEDLE AND CANNULA K950282 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Apr 1995. https://www.510kdatabase.net/k950072/ 1995-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k950072-immuliter-tbg-fda-510k.jpg K950072 - IMMULITE(R) TBG K950072 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Apr 1995. https://www.510kdatabase.net/k950883/ 1995-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k950883-polydoros-sx-65-and-80-fda-510k.jpg K950883 - POLYDOROS SX 65 AND 80 K950883 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 1995. https://www.510kdatabase.net/k951251/ 1995-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k951251-karl-storz-puncture-injection-fda-510k.jpg K951251 - KARL STORZ PUNCTURE, INJECTION, ENDOSCOPIC, VERESS NEEDLE K951251 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Apr 1995. https://www.510kdatabase.net/k944844/ 1995-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k944844-baxter-reinforced-expanded-ptfe-fda-510k.jpg K944844 - BAXTER REINFORCED EXPANDED PTFE STEPPED VASCULAR GRAFT K944844 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 1995. https://www.510kdatabase.net/k944873/ 1995-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k944873-triflex-non-sterile-synthitic-fda-510k.jpg K944873 - TRIFLEX NON-STERILE SYNTHITIC EXAMINATION GLOVES K944873 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 1995. https://www.510kdatabase.net/k945652/ 1995-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k945652-attenuation-correction-fda-510k.jpg K945652 - ATTENUATION CORRECTION K945652 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Mar 1995. https://www.510kdatabase.net/k945743/ 1995-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k945743-preference-mammography-system-fda-510k.jpg K945743 - PREFERENCE MAMMOGRAPHY SYSTEM K945743 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Mar 1995. https://www.510kdatabase.net/k946053/ 1995-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k946053-simviewtm-3000-fda-510k.jpg K946053 - SIMVIEW(TM) 3000 K946053 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 1995. https://www.510kdatabase.net/k950894/ 1995-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k950894-surefire-pf-high-palladium-dental-fda-510k.jpg K950894 - SUREFIRE PF+ (HIGH PALLADIUM DENTAL CASTING ALLOY FOR PORCELAIN APPLICATIONS) K950894 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Mar 1995. https://www.510kdatabase.net/k950965/ 1995-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k950965-karl-storz-stent-applicator-forceps-fda-510k.jpg K950965 - KARL STORZ STENT APPLICATOR FORCEPS K950965 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Mar 1995. https://www.510kdatabase.net/k945211/ 1995-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k945211-karl-storz-retractore-probes-fda-510k.jpg K945211 - KARL STORZ RETRACTORE, PROBES, DISSECTORS, HOOKS, UTERINEELEVATORS, UTERINE CANNULAE K945211 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Mar 1995. https://www.510kdatabase.net/k950135/ 1995-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k950135-urine-amphetamines-screen-flextm-fda-510k.jpg K950135 - URINE AMPHETAMINES SCREEN FLEX(TM) REAGENT CARTRIDGE K950135 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Mar 1995. https://www.510kdatabase.net/k950496/ 1995-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k950496-snare-flexible-electrosurgical-cutting-fda-510k.jpg K950496 - SNARE, FLEXIBLE, ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES K950496 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Mar 1995. https://www.510kdatabase.net/k950590/ 1995-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k950590-rep-cholesterol-profile-control-fda-510k.jpg K950590 - REP CHOLESTEROL PROFILE CONTROL K950590 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Mar 1995. https://www.510kdatabase.net/k950801/ 1995-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k950801-cardio-rep-ld-control-cat-no-3325-fda-510k.jpg K950801 - CARDIO REP LD CONTROL - CAT NO. 3325 K950801 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Mar 1995. https://www.510kdatabase.net/k936047/ 1995-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k936047-spectrumtm-mask-fda-510k.jpg K936047 - SPECTRUM(TM) MASK K936047 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Mar 1995. https://www.510kdatabase.net/k943603/ 1995-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k943603-aesculap-laparoscopic-ancillary-devices-fda-510k.jpg K943603 - AESCULAP LAPAROSCOPIC ANCILLARY DEVICES K943603 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Aesculap, Inc.. Cleared Mar 1995. https://www.510kdatabase.net/k945616/ 1995-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k945616-cordis-avanti-catheter-sheath-introducer-fda-510k.jpg K945616 - CORDIS AVANTI CATHETER SHEATH INTRODUCER K945616 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Mar 1995. https://www.510kdatabase.net/k950277/ 1995-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k950277-insurg-laptie-plus-suture-ligator-with-fda-510k.jpg K950277 - INSURG LAPTIE PLUS SUTURE LIGATOR WITH NEEDLE DRIVER K950277 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Boston Scientific Corp. Cleared Mar 1995. https://www.510kdatabase.net/k950434/ 1995-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k950434-karl-storz-flexible-grasping-biopsy-fda-510k.jpg K950434 - KARL STORZ FLEXIBLE GRASPING, BIOPSY FORCEPS, STONE BASKETS, DISLODGERS, SCISSORS, INJECTION CANNULAE, CLEANING BRUSHES K950434 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Mar 1995. https://www.510kdatabase.net/k932866/ 1995-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k932866-resolut-regenerative-material-fda-510k.jpg K932866 - RESOLUT REGENERATIVE MATERIAL K932866 is a FDA 510(k) cleared dental medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Mar 1995. https://www.510kdatabase.net/k944765/ 1995-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k944765-karl-storz-insulated-biopsy-forceps-fda-510k.jpg K944765 - KARL STORZ INSULATED BIOPSY FORCEPS, GRASPING/DISSECTING FORECPS, FLEXIBLE FORCEPS K944765 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Mar 1995. https://www.510kdatabase.net/k946328/ 1995-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k946328-tdxrtdxflxr-phenytoin-ii-fda-510k.jpg K946328 - TDX(R)/TDXFLX(R) PHENYTOIN II K946328 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1995. https://www.510kdatabase.net/k950811/ 1995-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k950811-karl-storz-fiber-optic-ligh-cables-fda-510k.jpg K950811 - KARL STORZ FIBER OPTIC LIGH CABLES K950811 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Mar 1995. https://www.510kdatabase.net/k941596/ 1995-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k941596-remedi-hs-drug-profiling-system-fda-510k.jpg K941596 - REMEDI HS DRUG PROFILING SYSTEM K941596 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bio-Rad. Cleared Mar 1995. https://www.510kdatabase.net/k950707/ 1995-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k950707-n-latex-ferritin-fda-510k.jpg K950707 - N LATEX FERRITIN K950707 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Mar 1995. https://www.510kdatabase.net/k950900/ 1995-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k950900-olympus-igm-immunoturbidimetric-reagent-fda-510k.jpg K950900 - OLYMPUS IGM IMMUNOTURBIDIMETRIC REAGENT K950900 is a FDA 510(k) cleared immunology medical device. Manufacturer: Olympus America, Inc.. Cleared Mar 1995. https://www.510kdatabase.net/k935192/ 1995-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k935192-emit-iic-calibrators-fda-510k.jpg K935192 - EMIT IIC CALIBRATORS K935192 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Mar 1995. https://www.510kdatabase.net/k944768/ 1995-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k944768-olympus-inorganic-phosphorus-reagent-fda-510k.jpg K944768 - OLYMPUS INORGANIC PHOSPHORUS REAGENT K944768 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus America, Inc.. Cleared Mar 1995. https://www.510kdatabase.net/k950964/ 1995-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k950964-karl-storz-intra-handpieces-and-fda-510k.jpg K950964 - KARL STORZ INTRA-HANDPIECES AND ACCESSORIES K950964 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Mar 1995. https://www.510kdatabase.net/k951092/ 1995-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k951092-catheter-securement-device-fda-510k.jpg K951092 - CATHETER SECUREMENT DEVICE K951092 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 1995. https://www.510kdatabase.net/k951173/ 1995-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k951173-manual-surgical-instrument-for-general-fda-510k.jpg K951173 - MANUAL SURGICAL INSTRUMENT FOR GENERAL USE K951173 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Mar 1995. https://www.510kdatabase.net/k943767/ 1995-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k943767-immulite-c-peptide-fda-510k.jpg K943767 - IMMULITE C-PEPTIDE K943767 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Mar 1995. https://www.510kdatabase.net/k943919/ 1995-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k943919-95-fr-sensation-dl-intra-aortic-ballon-fda-510k.jpg K943919 - 9.5 FR SENSATION DL INTRA-AORTIC BALLON CATHETER K943919 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Mar 1995. https://www.510kdatabase.net/k950991/ 1995-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k950991-dyract-ii-restorative-fda-510k.jpg K950991 - DYRACT II RESTORATIVE K950991 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Mar 1995. https://www.510kdatabase.net/k932070/ 1995-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k932070-duracon-stabilizer-femoral-component-fda-510k.jpg K932070 - DURACON STABILIZER FEMORAL COMPONENT AND INSERT K932070 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Mar 1995. https://www.510kdatabase.net/k943349/ 1995-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k943349-mahurkar-dual-lumen-catheter-fda-510k.jpg K943349 - MAHURKAR DUAL LUMEN CATHETER K943349 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Quinton, Inc.. Cleared Mar 1995. https://www.510kdatabase.net/k945658/ 1995-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k945658-interwoventm-reusable-surgical-gown-fda-510k.jpg K945658 - INTERWOVEN(TM) REUSABLE SURGICAL GOWN K945658 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 1995. https://www.510kdatabase.net/k945889/ 1995-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k945889-karl-storz-plastic-surgery-accessories-fda-510k.jpg K945889 - KARL STORZ PLASTIC SURGERY ACCESSORIES K945889 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Mar 1995. https://www.510kdatabase.net/k946267/ 1995-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k946267-gore-tex-sam-facial-implant-fda-510k.jpg K946267 - GORE-TEX SAM FACIAL IMPLANT K946267 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Mar 1995. https://www.510kdatabase.net/k931746/ 1995-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k931746-latex-k82-fda-510k.jpg K931746 - LATEX (K82) K931746 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Mar 1995. https://www.510kdatabase.net/k945037/ 1995-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k945037-siemens-1481-t-transmitter-enhanced-fda-510k.jpg K945037 - SIEMENS 1481 T TRANSMITTER, ENHANCED K945037 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 1995. https://www.510kdatabase.net/k945982/ 1995-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k945982-karl-storz-take-apartr-suture-forceps-fda-510k.jpg K945982 - KARL STORZ TAKE-APART(R) SUTURE FORCEPS, KNOT TIER K945982 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Mar 1995. https://www.510kdatabase.net/k950028/ 1995-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k950028-primidone-fpia-reagent-set-and-fda-510k.jpg K950028 - PRIMIDONE FPIA REAGENT SET AND CALIBRATORS K950028 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Mar 1995. https://www.510kdatabase.net/k950134/ 1995-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k950134-urine-cocaine-metabolite-screen-flextm-fda-510k.jpg K950134 - URINE COCAINE METABOLITE SCREEN FLEX(TM) REAGENT CATRIDGE K950134 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Mar 1995. https://www.510kdatabase.net/k950182/ 1995-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k950182-urine-methadone-screen-flextm-reagent-fda-510k.jpg K950182 - URINE METHADONE SCREEN FLEX(TM) REAGENT CARTRIDGE K950182 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Mar 1995. https://www.510kdatabase.net/k950427/ 1995-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k950427-urine-benzodiazepines-screen-flex-fda-510k.jpg K950427 - URINE BENZODIAZEPINES SCREEN FLEX TEAGENT CARTRIDGE K950427 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Mar 1995. https://www.510kdatabase.net/k950541/ 1995-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k950541-howmedica-v40-22mm-femoral-head-fda-510k.jpg K950541 - HOWMEDICA V40 22MM FEMORAL HEAD K950541 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Mar 1995. https://www.510kdatabase.net/k950976/ 1995-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k950976-karl-storz-adult-and-pediatric-viscous-fda-510k.jpg K950976 - KARL STORZ ADULT AND PEDIATRIC VISCOUS FLUID INJECTION SETS K950976 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Mar 1995. https://www.510kdatabase.net/k941990/ 1995-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k941990-benozodiazepines-and-tricylic-fda-510k.jpg K941990 - BENOZODIAZEPINES AND TRICYLIC ANTIDEPRESSANTS BY HPLC K941990 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bio-Rad. Cleared Mar 1995. https://www.510kdatabase.net/k941994/ 1995-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k941994-benzodiazepines-and-tricyclic-fda-510k.jpg K941994 - BENZODIAZEPINES AND TRICYCLIC ANTIDEPRESSANTS BY HPLC K941994 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bio-Rad. Cleared Mar 1995. https://www.510kdatabase.net/k950183/ 1995-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k950183-urine-phencyclidine-screen-flextm-fda-510k.jpg K950183 - URINE PHENCYCLIDINE SCREEN FLEX(TM) REAGENT CARTRIDGE K950183 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Mar 1995. https://www.510kdatabase.net/k943389/ 1995-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k943389-sidestream-pump-plug-in-module-of-fda-510k.jpg K943389 - SIDESTREAM PUMP PLUG-IN MODULE OF COMPONENT MONITORING SYSTEM K943389 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Mar 1995. https://www.510kdatabase.net/k945087/ 1995-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k945087-ortholoc-advantim-porous-coated-tibial-fda-510k.jpg K945087 - ORTHOLOC ADVANTIM POROUS COATED TIBIAL BASE K945087 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Mar 1995. https://www.510kdatabase.net/k945691/ 1995-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k945691-osteonicsr-threaded-ha-acetabular-shells-fda-510k.jpg K945691 - OSTEONICS(R) THREADED HA ACETABULAR SHELLS K945691 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Mar 1995. https://www.510kdatabase.net/k950729/ 1995-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k950729-olympus-pr-23q-disposable-cannula-ball-fda-510k.jpg K950729 - OLYMPUS PR-23Q DISPOSABLE CANNULA (BALL TIP) K950729 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus America, Inc.. Cleared Mar 1995. https://www.510kdatabase.net/k945719/ 1995-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k945719-aspir-pulsetm-arterial-blood-gas-abg-fda-510k.jpg K945719 - ASPIR-PULSE(TM) ARTERIAL BLOOD GAS (ABG) SYSTEM K945719 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sherwood Medical Co.. Cleared Mar 1995. https://www.510kdatabase.net/k950232/ 1995-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k950232-laparoscope-and-accessories-for-obgyn-fda-510k.jpg K950232 - LAPAROSCOPE AND ACCESSORIES FOR OB/GYN K950232 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Olympus America, Inc.. Cleared Mar 1995. https://www.510kdatabase.net/k950858/ 1995-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k950858-aurolite-55-fda-510k.jpg K950858 - AUROLITE 55 K950858 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Mar 1995. https://www.510kdatabase.net/k951060/ 1995-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k951060-karl-storz-koh-needle-holders-forceps-fda-510k.jpg K951060 - KARL STORZ KOH NEEDLE HOLDERS, FORCEPS FOR SUTURING, SUTURE SCISSORS, TISSUE PROBES, INJECTION NEEDLE, IRRIGATION INSTRN K951060 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Mar 1995. https://www.510kdatabase.net/k933278/ 1995-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k933278-intermedics-triangle-chest-probe-model-fda-510k.jpg K933278 - INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04 K933278 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Mar 1995. https://www.510kdatabase.net/k942900/ 1995-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k942900-osteonics-secure-fit-ad-ha-acetabular-fda-510k.jpg K942900 - OSTEONICS SECURE-FIT AD-HA ACETABULAR COMPONENT SYSTEM K942900 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Mar 1995. https://www.510kdatabase.net/k944406/ 1995-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k944406-olympus-glucose-reagent-fda-510k.jpg K944406 - OLYMPUS GLUCOSE REAGENT K944406 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus America, Inc.. Cleared Mar 1995. https://www.510kdatabase.net/k945809/ 1995-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k945809-monojectr-vertical-entry-sharps-fda-510k.jpg K945809 - MONOJECT(R) VERTICAL ENTRY SHARPS CONTAINER (1 QT) K945809 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Mar 1995. https://www.510kdatabase.net/k950007/ 1995-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k950007-surgical-instrument-guide-fda-510k.jpg K950007 - SURGICAL INSTRUMENT GUIDE K950007 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Mar 1995. https://www.510kdatabase.net/k950180/ 1995-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k950180-dupont-dimensionr-pseudocholinesterase-fda-510k.jpg K950180 - DUPONT DIMENSION(R) PSEUDOCHOLINESTERASE METHOD K950180 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Mar 1995. https://www.510kdatabase.net/k950433/ 1995-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k950433-karl-storz-endopyelotomy-set-for-fda-510k.jpg K950433 - KARL STORZ ENDOPYELOTOMY SET FOR ENDOSCOPIC UROLOGY PROCEDURES K950433 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Mar 1995. https://www.510kdatabase.net/k950953/ 1995-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k950953-karl-storz-pediatric-vancaillie-take-fda-510k.jpg K950953 - KARL STORZ PEDIATRIC VANCAILLIE TAKE-APART BIPOLAR MICRO-FORCEPS, MANHES TAKE-APART BIPOLAR FORCEPS, VBIPOLAR COAGULATEE K950953 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Mar 1995. https://www.510kdatabase.net/k943195/ 1995-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k943195-coat-a-count-neonatal-tsh-irma-fda-510k.jpg K943195 - COAT-A-COUNT NEONATAL TSH IRMA K943195 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Mar 1995. https://www.510kdatabase.net/k945396/ 1995-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k945396-fluoro-tipr-hemostasis-valve-fda-510k.jpg K945396 - FLUORO-TIP(R) HEMOSTASIS VALVE INTRODUCER SET K945396 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Mar 1995. https://www.510kdatabase.net/k950772/ 1995-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k950772-argelite-61-palladium-silver-dental-fda-510k.jpg K950772 - ARGELITE 61 (PALLADIUM - SILVER DENTAL CASTING ALLOY FOR PORCELAIN APPLICATIONS) K950772 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Mar 1995. https://www.510kdatabase.net/k912456/ 1995-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k912456-sundt-slim-line-graft-clips-fda-510k.jpg K912456 - SUNDT SLIM-LINE GRAFT CLIPS K912456 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Mar 1995. https://www.510kdatabase.net/k933494/ 1995-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k933494-exactech-posterior-stabilized-cemented-fda-510k.jpg K933494 - EXACTECH POSTERIOR STABILIZED CEMENTED TOTAL KNEE SYSTEM K933494 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Mar 1995. https://www.510kdatabase.net/k944933/ 1995-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k944933-immulite-hpl-human-placental-plactogen-fda-510k.jpg K944933 - IMMULITE (HPL) (HUMAN PLACENTAL PLACTOGEN) K944933 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Mar 1995. https://www.510kdatabase.net/k945523/ 1995-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k945523-cobasr-fp-reagents-for-gentamicin-and-fda-510k.jpg K945523 - COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORS K945523 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Mar 1995. https://www.510kdatabase.net/k934515/ 1995-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k934515-biastm-fiber-metal-total-hip-stem-tfb-fda-510k.jpg K934515 - BIAS(TM) FIBER METAL TOTAL HIP STEM (TFB) K934515 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Mar 1995. https://www.510kdatabase.net/k945294/ 1995-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k945294-dall-miles-system-homogeneous-fda-510k.jpg K945294 - DALL MILES SYSTEM HOMOGENEOUS VITALLIUM CABLE K945294 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Mar 1995. https://www.510kdatabase.net/k945839/ 1995-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k945839-sastm-qc-antigens-for-salmonella-fda-510k.jpg K945839 - SAS(TM) QC ANTIGENS FOR SALMONELLA ANTISERA K945839 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Mar 1995. https://www.510kdatabase.net/k945964/ 1995-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k945964-kangaroor-524-enteral-feeding-pump-and-fda-510k.jpg K945964 - KANGAROO(R) 524 ENTERAL FEEDING PUMP AND ADMINISTRATION SETS K945964 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Mar 1995. https://www.510kdatabase.net/k930503/ 1995-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k930503-clirans-wet-pack-hollow-fiber-dialyzer-fda-510k.jpg K930503 - CLIRANS WET PACK HOLLOW FIBER DIALYZER K930503 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Terumo Medical Corp.. Cleared Mar 1995. https://www.510kdatabase.net/k943768/ 1995-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k943768-honey-bee-yellow-jacket-paper-wasp-fda-510k.jpg K943768 - HONEY BEE, YELLOW JACKET, PAPER WASP, IMPORTED FIRE ANT K943768 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Mar 1995. https://www.510kdatabase.net/k943774/ 1995-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k943774-osteonics-restoration-monolithic-hip-fda-510k.jpg K943774 - OSTEONICS RESTORATION MONOLITHIC HIP STEM K943774 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Mar 1995. https://www.510kdatabase.net/k943957/ 1995-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k943957-restoration-ha-acetabular-cup-series-fda-510k.jpg K943957 - RESTORATION HA ACETABULAR CUP SERIES K943957 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Mar 1995. https://www.510kdatabase.net/k945209/ 1995-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k945209-proctoscopea-accessories-fda-510k.jpg K945209 - PROCTOSCOPEA & ACCESSORIES, SIGMOIDOSCOPES & ACCESSORIES, PROCTOLOGY INSTRUMENTS K945209 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Mar 1995. https://www.510kdatabase.net/k945613/ 1995-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k945613-duracontm-unicompartmental-femoral-fda-510k.jpg K945613 - DURACON(TM) UNICOMPARTMENTAL FEMORAL COMPONENT K945613 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Mar 1995. https://www.510kdatabase.net/k950103/ 1995-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k950103-laparoscope-hand-instruments-fda-510k.jpg K950103 - LAPAROSCOPE, HAND INSTRUMENTS K950103 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Olympus America, Inc.. Cleared Mar 1995. https://www.510kdatabase.net/k950786/ 1995-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k950786-olympus-biopsy-forceps-model-fb-44-fda-510k.jpg K950786 - OLYMPUS BIOPSY FORCEPS MODEL FB-44 K950786 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Olympus America, Inc.. Cleared Mar 1995. https://www.510kdatabase.net/k945953/ 1995-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k945953-gore-laparoscopic-suture-passer-non-fda-510k.jpg K945953 - GORE LAPAROSCOPIC SUTURE PASSER (NON-STERILE) K945953 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Mar 1995. https://www.510kdatabase.net/k946052/ 1995-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k946052-powerflextm-5f-pta-balloon-catheter-fda-510k.jpg K946052 - POWERFLEX(TM) 5F PTA BALLOON CATHETER K946052 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Mar 1995. https://www.510kdatabase.net/k950076/ 1995-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k950076-laparoscope-fda-510k.jpg K950076 - LAPAROSCOPE K950076 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Olympus America, Inc.. Cleared Mar 1995. https://www.510kdatabase.net/k946331/ 1995-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k946331-karl-storz-bougies-sounds-dilators-fda-510k.jpg K946331 - KARL STORZ BOUGIES, SOUNDS, DILATORS K946331 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Mar 1995. https://www.510kdatabase.net/k922217/ 1995-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k922217-flexiflo-nasoenteric-feeding-tube-fda-510k.jpg K922217 - FLEXIFLO NASOENTERIC FEEDING TUBE K922217 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1995. https://www.510kdatabase.net/k940648/ 1995-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k940648-cordis-disposable-icp-pressure-fda-510k.jpg K940648 - CORDIS DISPOSABLE ICP PRESSURE TRANSDUCER K940648 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cordis Corp.. Cleared Mar 1995. https://www.510kdatabase.net/k944048/ 1995-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k944048-ultrasound-77030-imaging-system-fda-510k.jpg K944048 - ULTRASOUND 77030 IMAGING SYSTEM K944048 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Mar 1995. https://www.510kdatabase.net/k945715/ 1995-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k945715-monojectr-piston-syringes-fda-510k.jpg K945715 - MONOJECT(R) PISTON SYRINGES K945715 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Mar 1995. https://www.510kdatabase.net/k932276/ 1995-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k932276-co2-hydromat-pump-for-irrigation-model-fda-510k.jpg K932276 - CO2 HYDROMAT PUMP FOR IRRIGATION, MODEL #26310020 K932276 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Feb 1995. https://www.510kdatabase.net/k943773/ 1995-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k943773-sterile-water-fda-510k.jpg K943773 - STERILE WATER K943773 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Feb 1995. https://www.510kdatabase.net/k950334/ 1995-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k950334-karl-storz-tele-scrub-fda-510k.jpg K950334 - KARL STORZ TELE-SCRUB K950334 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Feb 1995. https://www.510kdatabase.net/k950603/ 1995-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k950603-karl-storz-viscous-fluid-injection-set-fda-510k.jpg K950603 - KARL STORZ VISCOUS FLUID INJECTION SET K950603 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Feb 1995. https://www.510kdatabase.net/k950636/ 1995-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k950636-olympus-disposable-biopsy-forceps-fda-510k.jpg K950636 - OLYMPUS DISPOSABLE BIOPSY FORCEPS K950636 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Olympus America, Inc.. Cleared Feb 1995. https://www.510kdatabase.net/k942454/ 1995-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k942454-datascope-95-and-97-iab-pump-console-fda-510k.jpg K942454 - DATASCOPE 95 AND 97 IAB PUMP CONSOLE K942454 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Feb 1995. https://www.510kdatabase.net/k950338/ 1995-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k950338-karl-storz-rhino-pharyngo-laryngo-fda-510k.jpg K950338 - KARL STORZ RHINO-PHARYNGO-LARYNGO-FIBERSCOPE, BIOPSY, GRASPING FORCEPS K950338 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Feb 1995. https://www.510kdatabase.net/k950503/ 1995-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k950503-manual-surgical-instrument-for-general-fda-510k.jpg K950503 - MANUAL SURGICAL INSTRUMENT FOR GENERAL USE K950503 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Feb 1995. https://www.510kdatabase.net/k943193/ 1995-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k943193-coat-a-countr-estradiol-6-fda-510k.jpg K943193 - COAT-A-COUNT(R) ESTRADIOL-6 K943193 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Feb 1995. https://www.510kdatabase.net/k943194/ 1995-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k943194-immuliter-allergy-food-panel-fp5e-fda-510k.jpg K943194 - IMMULITE(R) ALLERGY FOOD PANEL FP5E K943194 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Feb 1995. https://www.510kdatabase.net/k935116/ 1995-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k935116-emit-iic-barbiturate-assay-fda-510k.jpg K935116 - EMIT IIC BARBITURATE ASSAY K935116 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Feb 1995. https://www.510kdatabase.net/k935191/ 1995-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k935191-emit-iic-phencyclidine-assay-fda-510k.jpg K935191 - EMIT IIC PHENCYCLIDINE ASSAY K935191 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Feb 1995. https://www.510kdatabase.net/k935323/ 1995-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k935323-emit-iic-cocaine-metabolite-assay-fda-510k.jpg K935323 - EMIT IIC COCAINE METABOLITE ASSAY K935323 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Feb 1995. https://www.510kdatabase.net/k935352/ 1995-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k935352-emitr-iic-amphetamine-assay-fda-510k.jpg K935352 - EMIT(R) IIC AMPHETAMINE ASSAY K935352 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Feb 1995. https://www.510kdatabase.net/k940158/ 1995-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k940158-emit-iic-cannabinoid-assay-fda-510k.jpg K940158 - EMIT IIC CANNABINOID ASSAY K940158 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Feb 1995. https://www.510kdatabase.net/k942145/ 1995-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k942145-non-uniform-attenuation-correction-fda-510k.jpg K942145 - NON-UNIFORM ATTENUATION CORRECTION SYSTEM K942145 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 1995. https://www.510kdatabase.net/k943736/ 1995-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k943736-cvpro-cardiovascular-patch-fda-510k.jpg K943736 - CVPRO CARDIOVASCULAR PATCH K943736 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Feb 1995. https://www.510kdatabase.net/k946153/ 1995-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k946153-digoxin-flextm-reagent-cartridge-fda-510k.jpg K946153 - DIGOXIN FLEX(TM) REAGENT CARTRIDGE K946153 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Feb 1995. https://www.510kdatabase.net/k946163/ 1995-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k946163-radias-total-t4-enzyme-immunoassay-fda-510k.jpg K946163 - RADIAS TOTAL T4 ENZYME IMMUNOASSAY K946163 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Feb 1995. https://www.510kdatabase.net/k946183/ 1995-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k946183-clinitek-atlas-automated-urine-fda-510k.jpg K946183 - CLINITEK ATLAS AUTOMATED URINE CHEMISTRY ANALYZER K946183 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Feb 1995. https://www.510kdatabase.net/k950138/ 1995-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k950138-drugs-of-abuse-controls-fda-510k.jpg K950138 - DRUGS OF ABUSE CONTROLS K950138 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Feb 1995. https://www.510kdatabase.net/k950139/ 1995-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k950139-drugs-of-abuse-calibrator-fda-510k.jpg K950139 - DRUGS OF ABUSE CALIBRATOR K950139 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Feb 1995. https://www.510kdatabase.net/k950166/ 1995-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k950166-olympus-kd-6g1-9q-wire-guided-fda-510k.jpg K950166 - OLYMPUS KD-6G1-9Q WIRE GUIDED PAPILLOTOMU KNIFE K950166 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus America, Inc.. Cleared Feb 1995. https://www.510kdatabase.net/k944861/ 1995-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k944861-karl-storz-monopolar-coagulation-ball-fda-510k.jpg K944861 - KARL STORZ MONOPOLAR COAGULATION BALL ELECTRODES, CUTTING WIRE ELECTRODES, BIPOLAR SUCTION COAGULATOR, ELECTRODE, PROBE K944861 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Feb 1995. https://www.510kdatabase.net/k950055/ 1995-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k950055-a4722-olympus-optical-obturator-fda-510k.jpg K950055 - A4722 OLYMPUS OPTICAL OBTURATOR K950055 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Olympus America, Inc.. Cleared Feb 1995. https://www.510kdatabase.net/k945890/ 1995-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k945890-karl-storz-take-apartr-suture-forceps-fda-510k.jpg K945890 - KARL STORZ TAKE-APART(R) SUTURE FORCEPS, KARL STORZ KNOT TIER K945890 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Feb 1995. https://www.510kdatabase.net/k934065/ 1995-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k934065-medtronic-mattrix-32713272-fda-510k.jpg K934065 - MEDTRONIC MATTRIX 3271/3272 NEUROSTIMULATION SYSTEM K934065 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Feb 1995. https://www.510kdatabase.net/k922757/ 1995-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k922757-sps-1550-single-needle-patient-system-fda-510k.jpg K922757 - SPS 1550 SINGLE NEEDLE PATIENT SYSTEM K922757 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Feb 1995. https://www.510kdatabase.net/k945497/ 1995-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k945497-b-d-durasafetm-variable-extension-fda-510k.jpg K945497 - B-D DURASAFE)TM) VARIABLE EXTENSION COMBINED SPINAL EPIDURAL *CSE) NEEDLE SET/KIT K945497 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Feb 1995. https://www.510kdatabase.net/k945686/ 1995-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k945686-karl-storz-knives-curettes-fda-510k.jpg K945686 - KARL STORZ KNIVES, CURETTES K945686 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Feb 1995. https://www.510kdatabase.net/k945899/ 1995-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k945899-gore-texr-curved-surgicalmembrane-fda-510k.jpg K945899 - GORE-TEX(R) CURVED SURGICALMEMBRANE K945899 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Feb 1995. https://www.510kdatabase.net/k950336/ 1995-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k950336-karl-storz-adapters-for-documentation-fda-510k.jpg K950336 - KARL STORZ ADAPTERS FOR DOCUMENTATION PURPOSES K950336 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Feb 1995. https://www.510kdatabase.net/k932950/ 1995-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k932950-tina-quant-microalbumin-fda-510k.jpg K932950 - TINA-QUANT MICROALBUMIN K932950 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Feb 1995. https://www.510kdatabase.net/k943597/ 1995-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k943597-monarch-aptm-fda-510k.jpg K943597 - MONARCH AP(TM) K943597 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Feb 1995. https://www.510kdatabase.net/k932690/ 1995-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k932690-exactech-cruciate-retaining-cemented-fda-510k.jpg K932690 - EXACTECH CRUCIATE RETAINING CEMENTED TOTAL KNEE SY K932690 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Feb 1995. https://www.510kdatabase.net/k944862/ 1995-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k944862-karl-storz-insulated-dissecting-fda-510k.jpg K944862 - KARL STORZ INSULATED DISSECTING CANNULAE, CANNULAE, SUCTION TUBES K944862 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Feb 1995. https://www.510kdatabase.net/k945397/ 1995-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k945397-angio-ii-fda-510k.jpg K945397 - ANGIO II K945397 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Feb 1995. https://www.510kdatabase.net/k946148/ 1995-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k946148-karl-stors-knives-curettes-hooks-needles-fda-510k.jpg K946148 - KARL STORS KNIVES, CURETTES, HOOKS, NEEDLES K946148 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Feb 1995. https://www.510kdatabase.net/k950036/ 1995-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k950036-olympus-5fr-semi-rigid-scissors-for-fda-510k.jpg K950036 - OLYMPUS 5FR SEMI-RIGID SCISSORS FOR OB/GYN K950036 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Olympus America, Inc.. Cleared Feb 1995. https://www.510kdatabase.net/k950198/ 1995-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k950198-manual-surgical-instrument-for-general-fda-510k.jpg K950198 - MANUAL SURGICAL INSTRUMENT FOR GENERAL USE K950198 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Feb 1995. https://www.510kdatabase.net/k940817/ 1995-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k940817-tdxrtdxflxr-fetal-lung-maturity-ii-fda-510k.jpg K940817 - TDX(R)/TDXFLX(R) FETAL LUNG MATURITY II K940817 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Feb 1995. https://www.510kdatabase.net/k944733/ 1995-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k944733-plum-xl-infusion-pump-fda-510k.jpg K944733 - PLUM XL INFUSION PUMP K944733 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Feb 1995. https://www.510kdatabase.net/k944816/ 1995-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k944816-sureview-mqsa-option-kits-model-nos-fda-510k.jpg K944816 - SUREVIEW MQSA OPTION KITS (MODEL NO.'S 377095 & 377096) K944816 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Feb 1995. https://www.510kdatabase.net/k950317/ 1995-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k950317-advantx-1824-spotfilm-device-fda-510k.jpg K950317 - ADVANTX 1824 SPOTFILM DEVICE K950317 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Feb 1995. https://www.510kdatabase.net/k934884/ 1995-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k934884-model-2231-co2-insufflator-fda-510k.jpg K934884 - MODEL 2231 CO2 INSUFFLATOR K934884 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Feb 1995. https://www.510kdatabase.net/k944013/ 1995-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k944013-ct-prospeed-family-fda-510k.jpg K944013 - CT PROSPEED FAMILY K944013 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Feb 1995. https://www.510kdatabase.net/k945210/ 1995-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k945210-ksea-disposable-tubing-set-for-the-fda-510k.jpg K945210 - KSEA DISPOSABLE TUBING SET FOR THE UROMAT PUMP K945210 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Feb 1995. https://www.510kdatabase.net/k945813/ 1995-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k945813-becton-dickinson-precision-cuttm-fda-510k.jpg K945813 - BECTON DICKINSON PRECISION CUT(TM) COAXIAL INTRODUCER NEEDLE WITH DEPTH STOP K945813 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Feb 1995. https://www.510kdatabase.net/k946119/ 1995-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k946119-roche-tdm-onleintm-controls-fda-510k.jpg K946119 - ROCHE-TDM ONLEIN(TM) CONTROLS K946119 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Feb 1995. https://www.510kdatabase.net/k950125/ 1995-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k950125-karl-storz-bougies-and-dilators-fda-510k.jpg K950125 - KARL STORZ BOUGIES AND DILATORS K950125 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Feb 1995. https://www.510kdatabase.net/k945458/ 1995-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k945458-vacutainer-brand-safety-gard-fda-510k.jpg K945458 - VACUTAINER BRAND SAFETY-GARD PHLEBOTOMY SYSTEM K945458 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Feb 1995. https://www.510kdatabase.net/k946330/ 1995-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k946330-karl-stortz-pivot-arm-laparoscope-fda-510k.jpg K946330 - KARL STORTZ PIVOT ARM LAPAROSCOPE SLEEVE, ENDO-RETRACTOR K946330 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Feb 1995. https://www.510kdatabase.net/k943303/ 1995-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k943303-pvk-357at-fda-510k.jpg K943303 - PVK-357AT K943303 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Feb 1995. https://www.510kdatabase.net/k944212/ 1995-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k944212-radias-red-cell-folate-immunoasay-fda-510k.jpg K944212 - RADIAS RED CELL FOLATE IMMUNOASAY K944212 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Feb 1995. https://www.510kdatabase.net/k945572/ 1995-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k945572-codmanr-ridig-and-steerable-endoscope-fda-510k.jpg K945572 - CODMAN(R) RIDIG AND STEERABLE ENDOSCOPE HOLDER, MODEL 83-1352 K945572 is a FDA 510(k) cleared neurology medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Feb 1995. https://www.510kdatabase.net/k941941/ 1995-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k941941-bone-mulch-screw-fda-510k.jpg K941941 - BONE MULCH SCREW K941941 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Feb 1995. https://www.510kdatabase.net/k943492/ 1995-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k943492-arthrex-staples-fda-510k.jpg K943492 - ARTHREX STAPLES K943492 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Feb 1995. https://www.510kdatabase.net/k945233/ 1995-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k945233-pediatric-osteotomy-system-fda-510k.jpg K945233 - PEDIATRIC OSTEOTOMY SYSTEM K945233 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Feb 1995. https://www.510kdatabase.net/k950231/ 1995-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k950231-laparoscope-and-accessories-for-fda-510k.jpg K950231 - LAPAROSCOPE AND ACCESSORIES FOR GENERAL SURGERY K950231 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Olympus America, Inc.. Cleared Feb 1995. https://www.510kdatabase.net/k950278/ 1995-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k950278-mini-laparoscopy-for-general-surgery-fda-510k.jpg K950278 - MINI LAPAROSCOPY FOR GENERAL SURGERY K950278 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Olympus America, Inc.. Cleared Feb 1995. https://www.510kdatabase.net/k933785/ 1995-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k933785-next-generation-knee-system-fda-510k.jpg K933785 - NEXT GENERATION KNEE SYSTEM K933785 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jan 1995. https://www.510kdatabase.net/k940813/ 1995-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k940813-osteonicsr-series-7000-total-knee-fda-510k.jpg K940813 - OSTEONICS(R) SERIES 7000 TOTAL KNEE K940813 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Jan 1995. https://www.510kdatabase.net/k945277/ 1995-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k945277-hewlett-packard-model-m1490a-wireless-fda-510k.jpg K945277 - HEWLETT-PACKARD MODEL M1490A WIRELESS PATIENT DATA COMMUNICATOR K945277 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Jan 1995. https://www.510kdatabase.net/k945375/ 1995-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k945375-advantx-lca-fda-510k.jpg K945375 - ADVANTX LCA K945375 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Jan 1995. https://www.510kdatabase.net/k945459/ 1995-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k945459-dlx-fda-510k.jpg K945459 - DLX K945459 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jan 1995. https://www.510kdatabase.net/k945580/ 1995-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k945580-dsp-option-fda-510k.jpg K945580 - DSP OPTION K945580 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Jan 1995. https://www.510kdatabase.net/k950127/ 1995-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k950127-alternate-100-eto-sterilization-fda-510k.jpg K950127 - ALTERNATE 100% ETO STERILIZATION PROCESS AND ALTERNATE STERILIZATION FACCILITY K950127 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Jan 1995. https://www.510kdatabase.net/k935781/ 1995-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k935781-argyle-salem-sump-tube-anti-reflux-fda-510k.jpg K935781 - ARGYLE SALEM SUMP TUBE ANTI-REFLUX VALVE INSERTION TRAY K935781 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Sherwood Medical Co.. Cleared Jan 1995. https://www.510kdatabase.net/k943299/ 1995-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k943299-depuy-amk-all-polyethylene-posterior-fda-510k.jpg K943299 - DEPUY AMK ALL POLYETHYLENE POSTERIOR STABLILIZED TIBIAL TRAY K943299 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jan 1995. https://www.510kdatabase.net/k946213/ 1995-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k946213-ksea-steiner-electromechanic-fda-510k.jpg K946213 - KSEA STEINER ELECTROMECHANIC MORCELLATORT K946213 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jan 1995. https://www.510kdatabase.net/k941622/ 1995-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k941622-echo-planar-imaging-option-for-the-fda-510k.jpg K941622 - ECHO PLANAR IMAGING OPTION FOR THE MAGNETOM VISION K941622 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 1995. https://www.510kdatabase.net/k944183/ 1995-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k944183-tru-touch-medical-gloves-fda-510k.jpg K944183 - TRU-TOUCH MEDICAL GLOVES K944183 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jan 1995. https://www.510kdatabase.net/k942687/ 1995-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k942687-il-test-carbamazepine-pn-181754-00-fda-510k.jpg K942687 - IL TEST CARBAMAZEPINE, PN 181754-00 K942687 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jan 1995. https://www.510kdatabase.net/k943982/ 1995-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k943982-il-test-gentamicin-calibrators-fda-510k.jpg K943982 - IL TEST GENTAMICIN CALIBRATORS K943982 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jan 1995. https://www.510kdatabase.net/k943999/ 1995-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k943999-abuscreen-ontrak-positive-control-fda-510k.jpg K943999 - ABUSCREEN ONTRAK POSITIVE CONTROL K943999 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jan 1995. https://www.510kdatabase.net/k944469/ 1995-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k944469-general-purpose-flex-coil-fda-510k.jpg K944469 - GENERAL PURPOSE FLEX COIL K944469 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Jan 1995. https://www.510kdatabase.net/k945788/ 1995-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k945788-karl-storz-rigid-telescopes-for-ent-fda-510k.jpg K945788 - KARL STORZ RIGID TELESCOPES FOR ENT ENDOSCOPIC PROCEDURES K945788 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jan 1995. https://www.510kdatabase.net/k946000/ 1995-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k946000-abuscreen-onliner-calibrators-fda-510k.jpg K946000 - ABUSCREEN ONLINE(R) CALIBRATORS K946000 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jan 1995. https://www.510kdatabase.net/k924425/ 1995-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k924425-protein-c-reagent-coagulometric-fda-510k.jpg K924425 - PROTEIN C REAGENT, COAGULOMETRIC K924425 is a FDA 510(k) cleared hematology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Jan 1995. https://www.510kdatabase.net/k931442/ 1995-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k931442-11274-ab-flexible-pediatric-bronchoscope-fda-510k.jpg K931442 - 11274 AB FLEXIBLE PEDIATRIC BRONCHOSCOPE K931442 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jan 1995. https://www.510kdatabase.net/k940970/ 1995-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k940970-yasargil-caspar-vario-clip-appliers-fda-510k.jpg K940970 - YASARGIL, CASPAR, VARIO CLIP APPLIERS K940970 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Jan 1995. https://www.510kdatabase.net/k943854/ 1995-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k943854-3m-model-8233-hearing-instrument-fda-510k.jpg K943854 - 3M MODEL 8233 HEARING INSTRUMENT K943854 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: 3M Company. Cleared Jan 1995. https://www.510kdatabase.net/k944793/ 1995-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k944793-karl-storz-monopolar-coagulation-fda-510k.jpg K944793 - KARL STORZ MONOPOLAR COAGULATION, NEEDLE, LOOP ELECTRODES K944793 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jan 1995. https://www.510kdatabase.net/k945100/ 1995-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k945100-karl-storz-suctionirrigation-tubes-fda-510k.jpg K945100 - KARL STORZ SUCTION/IRRIGATION TUBES, CANNULAE K945100 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jan 1995. https://www.510kdatabase.net/k942908/ 1995-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k942908-igm-rf-eia-fda-510k.jpg K942908 - IGM RF EIA K942908 is a FDA 510(k) cleared immunology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Jan 1995. https://www.510kdatabase.net/k943853/ 1995-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k943853-distal-radius-fracture-fixation-plate-fda-510k.jpg K943853 - DISTAL RADIUS FRACTURE FIXATION PLATE SYSTEM K943853 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jan 1995. https://www.510kdatabase.net/k945089/ 1995-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k945089-sentry-total-hip-fda-510k.jpg K945089 - SENTRY TOTAL HIP K945089 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jan 1995. https://www.510kdatabase.net/k945090/ 1995-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k945090-howmedica-zirconia-ceramic-femoral-head-fda-510k.jpg K945090 - HOWMEDICA ZIRCONIA CERAMIC FEMORAL HEAD K945090 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jan 1995. https://www.510kdatabase.net/k945092/ 1995-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k945092-pcaprimary-hip-cementless-use-fda-510k.jpg K945092 - P.C.A.PRIMARY HIP- CEMENTLESS USE K945092 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jan 1995. https://www.510kdatabase.net/k945094/ 1995-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k945094-hnr-pc-hip-fda-510k.jpg K945094 - HNR-PC HIP K945094 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jan 1995. https://www.510kdatabase.net/k945095/ 1995-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k945095-apc-femoral-component-fda-510k.jpg K945095 - APC FEMORAL COMPONENT K945095 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jan 1995. https://www.510kdatabase.net/k945096/ 1995-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k945096-cdh-hip-stem-fda-510k.jpg K945096 - CDH HIP STEM K945096 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jan 1995. https://www.510kdatabase.net/k930836/ 1995-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k930836-howmedicar-mono-tubetm-external-fda-510k.jpg K930836 - HOWMEDICA(R) MONO-TUBE(TM) EXTERNAL FIXATOR SYSTEM K930836 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jan 1995. https://www.510kdatabase.net/k941222/ 1995-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k941222-open-laparoscopy-trocar-cone-system-fda-510k.jpg K941222 - OPEN LAPAROSCOPY TROCAR CONE SYSTEM K941222 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Jan 1995. https://www.510kdatabase.net/k943979/ 1995-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k943979-il-test-theophylline-fda-510k.jpg K943979 - IL TEST THEOPHYLLINE K943979 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jan 1995. https://www.510kdatabase.net/k943981/ 1995-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k943981-il-test-phenobarbital-calibrators-fda-510k.jpg K943981 - IL TEST PHENOBARBITAL CALIBRATORS K943981 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jan 1995. https://www.510kdatabase.net/k944110/ 1995-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k944110-vicryl-rapide-suture-fda-510k.jpg K944110 - VICRYL RAPIDE SUTURE K944110 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Jan 1995. https://www.510kdatabase.net/k945091/ 1995-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k945091-howmedica-alumina-femoral-head-fda-510k.jpg K945091 - HOWMEDICA ALUMINA FEMORAL HEAD K945091 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jan 1995. https://www.510kdatabase.net/k945381/ 1995-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k945381-nasopharyngoscopes-bronchoscopes-fda-510k.jpg K945381 - NASOPHARYNGOSCOPES, BRONCHOSCOPES, TRACHEOSCP[ES AND ESOPHAGOSCOPES, LARYNGOSCOPES, OTO-TELESCOPES K945381 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jan 1995. https://www.510kdatabase.net/k945842/ 1995-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k945842-mobilix-mobile-x-ray-table-fda-510k.jpg K945842 - MOBILIX MOBILE X-RAY TABLE K945842 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Jan 1995. https://www.510kdatabase.net/k945952/ 1995-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k945952-vacutainerr-brand-plus-psttm-plasma-fda-510k.jpg K945952 - VACUTAINER(R) BRAND PLUS PST(TM) PLASMA SEPARATION TUBE K945952 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jan 1995. https://www.510kdatabase.net/k946164/ 1995-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k946164-ks-semi-rigid-micro-endoscopes-and-fda-510k.jpg K946164 - KS SEMI-RIGID MICRO-ENDOSCOPES AND ACCESSORIES FOR ADULT AND PEDIATRIC GENERAL ENDOSPOCIC AND LAPAROSCOPIC SURGICAL PROS K946164 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jan 1995. https://www.510kdatabase.net/k933610/ 1995-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k933610-exactech-cemented-total-knee-system-fda-510k.jpg K933610 - EXACTECH CEMENTED TOTAL KNEE SYSTEM, TIBIAL COMPONENTS K933610 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Jan 1995. https://www.510kdatabase.net/k941755/ 1995-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k941755-ortholoc-advantim-lsi-posterior-fda-510k.jpg K941755 - ORTHOLOC ADVANTIM LSI POSTERIOR STABLIZED ALL POLYTHYLENE TIBIAL COMPONENT K941755 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jan 1995. https://www.510kdatabase.net/k942298/ 1995-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k942298-the-karl-storz-arthropump-fda-510k.jpg K942298 - THE KARL STORZ ARTHROPUMP K942298 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jan 1995. https://www.510kdatabase.net/k944454/ 1995-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k944454-quanititate-gbcc-verifier-set-fda-510k.jpg K944454 - QUANITITATE GBCC VERIFIER SET K944454 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jan 1995. https://www.510kdatabase.net/k944455/ 1995-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k944455-quantitate-electrolyte-verifier-set-fda-510k.jpg K944455 - QUANTITATE ELECTROLYTE VERIFIER SET (SERUM RANGE) K944455 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jan 1995. https://www.510kdatabase.net/k944785/ 1995-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k944785-sas-quant-hcg-serum-fda-510k.jpg K944785 - SAS QUANT HCG SERUM K944785 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sa Scientific, Inc.. Cleared Jan 1995. https://www.510kdatabase.net/k944601/ 1995-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k944601-zimmer-zirconia-ceramic-femoral-head-fda-510k.jpg K944601 - ZIMMER ZIRCONIA CERAMIC FEMORAL HEAD K944601 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jan 1995. https://www.510kdatabase.net/k926567/ 1995-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k926567-baxter-ca-dialyzer-fda-510k.jpg K926567 - BAXTER CA DIALYZER K926567 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jan 1995. https://www.510kdatabase.net/k944072/ 1995-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k944072-olympus-nasal-and-sinus-endoscopes-fda-510k.jpg K944072 - OLYMPUS NASAL AND SINUS ENDOSCOPES K944072 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Olympus America, Inc.. Cleared Jan 1995. https://www.510kdatabase.net/k944757/ 1995-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k944757-piston-syringes-fda-510k.jpg K944757 - PISTON SYRINGES K944757 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jan 1995. https://www.510kdatabase.net/k945103/ 1995-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k945103-temp-and-permanent-neuro-leads-various-fda-510k.jpg K945103 - TEMP AND PERMANENT NEURO LEADS (VARIOUS MODELS) K945103 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Jan 1995. https://www.510kdatabase.net/k922216/ 1995-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k922216-flexiflo-tube-placement-verifier-fda-510k.jpg K922216 - FLEXIFLO TUBE PLACEMENT VERIFIER K922216 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Abbott Laboratories. Cleared Jan 1995. https://www.510kdatabase.net/k942537/ 1995-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k942537-paramount-cemented-hip-stem-prothesis-fda-510k.jpg K942537 - PARAMOUNT CEMENTED HIP STEM PROTHESIS K942537 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jan 1995. https://www.510kdatabase.net/k946173/ 1995-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k946173-stainless-steel-gut-poly-glycolidel-fda-510k.jpg K946173 - STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILK K946173 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Jan 1995. https://www.510kdatabase.net/k936273/ 1995-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k936273-stereo-opsis-camera-system-3-d-distal-fda-510k.jpg K936273 - STEREO OPSIS CAMERA SYSTEM 3-D DISTAL CAM AND 3-D DISTAL CAM 360 K936273 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jan 1995. https://www.510kdatabase.net/k944132/ 1995-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k944132-pfc-total-hip-system-fda-510k.jpg K944132 - P.F.C. TOTAL HIP SYSTEM K944132 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jan 1995. https://www.510kdatabase.net/k934699/ 1995-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k934699-respironics-bageasy-encor-adult-semi-fda-510k.jpg K934699 - RESPIRONICS BAGEASY ENCOR ADULT SEMI-REUSABLE K934699 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Jan 1995. https://www.510kdatabase.net/k944258/ 1995-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k944258-calcium-reagent-fda-510k.jpg K944258 - CALCIUM REAGENT K944258 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus America, Inc.. Cleared Jan 1995. https://www.510kdatabase.net/k945293/ 1995-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k945293-top-acom-station-fda-510k.jpg K945293 - TOP ACOM STATION K945293 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 1995. https://www.510kdatabase.net/k945201/ 1995-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k945201-coverd-gianturco-rosch-esophageal-z-fda-510k.jpg K945201 - COVERD GIANTURCO-ROSCH ESOPHAGEAL Z-STENT K945201 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook, Inc.. Cleared Jan 1995. https://www.510kdatabase.net/k944555/ 1994-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k944555-endoscope-fda-510k.jpg K944555 - ENDOSCOPE K944555 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Dec 1994. https://www.510kdatabase.net/k924850/ 1994-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k924850-vansonnenberg-gastrostomy-catheter-fda-510k.jpg K924850 - VANSONNENBERG GASTROSTOMY CATHETER K924850 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Dec 1994. https://www.510kdatabase.net/k944075/ 1994-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k944075-cxtm-barbituratesbarb-reagent-for-fda-510k.jpg K944075 - CX(TM) BARBITURATES(BARB) REAGENT FOR SYNCHRON CX SYST K944075 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Dec 1994. https://www.510kdatabase.net/k944086/ 1994-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k944086-cxtm-cannabinoid-50ngthc5-fda-510k.jpg K944086 - CX(TM) CANNABINOID 50NG(THC5) REAGENT/SYNCHRON CX SYS K944086 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Dec 1994. https://www.510kdatabase.net/k945769/ 1994-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k945769-total-etch-gel-fda-510k.jpg K945769 - TOTAL ETCH GEL K945769 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Dec 1994. https://www.510kdatabase.net/k944407/ 1994-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k944407-olympus-magnesium-reagent-fda-510k.jpg K944407 - OLYMPUS MAGNESIUM REAGENT K944407 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus America, Inc.. Cleared Dec 1994. https://www.510kdatabase.net/k945668/ 1994-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k945668-kxo-80g-fda-510k.jpg K945668 - KXO-80G K945668 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Dec 1994. https://www.510kdatabase.net/k945527/ 1994-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k945527-karl-storz-telescope-bridges-and-fda-510k.jpg K945527 - KARL STORZ TELESCOPE BRIDGES AND ADAPTERS K945527 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Dec 1994. https://www.510kdatabase.net/k944112/ 1994-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k944112-magnetic-resonance-diagnostic-accessory-fda-510k.jpg K944112 - MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY K944112 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Dec 1994. https://www.510kdatabase.net/k934334/ 1994-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k934334-apogee-hip-stem-with-porocoat-fda-510k.jpg K934334 - APOGEE HIP STEM WITH POROCOAT K934334 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Dec 1994. https://www.510kdatabase.net/k943176/ 1994-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k943176-karl-storz-hopkins-iiioperautoclavable-fda-510k.jpg K943176 - KARL STORZ HOPKINS I&II/OPER/AUTOCLAVABLE TELESCOPESQ K943176 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Dec 1994. https://www.510kdatabase.net/k943462/ 1994-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k943462-darwin-knee-system-fda-510k.jpg K943462 - DARWIN KNEE SYSTEM K943462 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Dec 1994. https://www.510kdatabase.net/k943906/ 1994-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k943906-pfc-cement-pressurizing-system-fda-510k.jpg K943906 - P.F.C. CEMENT PRESSURIZING SYSTEM K943906 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Dec 1994. https://www.510kdatabase.net/k944795/ 1994-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k944795-karl-storz-unipolar-ball-needle-loop-fda-510k.jpg K944795 - KARL STORZ UNIPOLAR BALL, NEEDLE, LOOP ELECTRODES K944795 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Dec 1994. https://www.510kdatabase.net/k945237/ 1994-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k945237-karl-storz-suctyionirrigation-tubes-fda-510k.jpg K945237 - KARL STORZ SUCTYION/IRRIGATION TUBES, CANNULAE K945237 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Dec 1994. https://www.510kdatabase.net/k943943/ 1994-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k943943-transtibial-acl-disposables-kit-fda-510k.jpg K943943 - TRANSTIBIAL ACL DISPOSABLES KIT K943943 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Dec 1994. https://www.510kdatabase.net/k944138/ 1994-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k944138-interwoven-optiguard-reusable-gown-fda-510k.jpg K944138 - INTERWOVEN OPTIGUARD REUSABLE GOWN MATERIAL K944138 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Dec 1994. https://www.510kdatabase.net/k946023/ 1994-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k946023-karl-storz-telescope-bridges-and-fda-510k.jpg K946023 - KARL STORZ TELESCOPE BRIDGES AND ADAPTERS K946023 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Dec 1994. https://www.510kdatabase.net/k931059/ 1994-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k931059-imx-rubella-igm-antibody-assay-fda-510k.jpg K931059 - IMX RUBELLA IGM ANTIBODY ASSAY K931059 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Dec 1994. https://www.510kdatabase.net/k932989/ 1994-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k932989-coat-a-count-free-estriol-fda-510k.jpg K932989 - COAT-A-COUNT FREE ESTRIOL K932989 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Dec 1994. https://www.510kdatabase.net/k933212/ 1994-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k933212-immulite-rapid-tsh-fda-510k.jpg K933212 - IMMULITE RAPID TSH K933212 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Dec 1994. https://www.510kdatabase.net/k933716/ 1994-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k933716-abbott-chagas-antibody-eia-fda-510k.jpg K933716 - ABBOTT CHAGAS ANTIBODY EIA K933716 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Dec 1994. https://www.510kdatabase.net/k935399/ 1994-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k935399-radias-neonatal-tsh-enzyme-immunoassay-fda-510k.jpg K935399 - RADIAS NEONATAL TSH ENZYME IMMUNOASSAY K935399 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Dec 1994. https://www.510kdatabase.net/k940006/ 1994-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k940006-immulite-third-generation-modification-fda-510k.jpg K940006 - IMMULITE THIRD GENERATION (MODIFICATION) K940006 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Dec 1994. https://www.510kdatabase.net/k941564/ 1994-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k941564-immulite-alatop-allergy-screen-fda-510k.jpg K941564 - IMMULITE ALATOP ALLERGY SCREEN K941564 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Dec 1994. https://www.510kdatabase.net/k941650/ 1994-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k941650-total-toe-system-ii-fda-510k.jpg K941650 - TOTAL TOE SYSTEM II K941650 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Dec 1994. https://www.510kdatabase.net/k943317/ 1994-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k943317-pathodx-respiratory-syncytial-virus-rsv-fda-510k.jpg K943317 - PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV) K943317 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Dec 1994. https://www.510kdatabase.net/k943522/ 1994-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k943522-the-prompt-guidwire-fda-510k.jpg K943522 - THE PROMPT GUIDWIRE K943522 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Dec 1994. https://www.510kdatabase.net/k943549/ 1994-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k943549-restoration-acetabular-cup-fda-510k.jpg K943549 - RESTORATION ACETABULAR CUP K943549 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Dec 1994. https://www.510kdatabase.net/k944211/ 1994-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k944211-immulite-progesterone-fda-510k.jpg K944211 - IMMULITE PROGESTERONE K944211 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Dec 1994. https://www.510kdatabase.net/k944285/ 1994-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k944285-osteonics-series-7000-total-knee-fda-510k.jpg K944285 - OSTEONICS SERIES 7000 TOTAL KNEE FEMORAL COMPONENTS K944285 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Dec 1994. https://www.510kdatabase.net/k944506/ 1994-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k944506-axsym-digoxin-fda-510k.jpg K944506 - AXSYM DIGOXIN K944506 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Dec 1994. https://www.510kdatabase.net/k944731/ 1994-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k944731-abbott-imx-2-analyzer-fda-510k.jpg K944731 - ABBOTT IMX 2 ANALYZER K944731 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Dec 1994. https://www.510kdatabase.net/k944814/ 1994-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k944814-corvac-plastic-blood-collection-tube-fda-510k.jpg K944814 - CORVAC PLASTIC BLOOD COLLECTION TUBE K944814 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sherwood Medical Co.. Cleared Dec 1994. https://www.510kdatabase.net/k943415/ 1994-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k943415-merit-o1t-mr-system-fda-510k.jpg K943415 - MERIT (O.1T MR SYSTEM) K943415 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Dec 1994. https://www.510kdatabase.net/k944297/ 1994-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k944297-karl-storz-insulated-scissors-fda-510k.jpg K944297 - KARL STORZ INSULATED SCISSORS K944297 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Dec 1994. https://www.510kdatabase.net/k944300/ 1994-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k944300-karl-storz-insulated-biopsy-forceps-fda-510k.jpg K944300 - KARL STORZ INSULATED BIOPSY FORCEPS K944300 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Dec 1994. https://www.510kdatabase.net/k944845/ 1994-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k944845-ortholoc-advantim-modular-femoral-fda-510k.jpg K944845 - ORTHOLOC ADVANTIM MODULAR FEMORAL AUGMENT COMPONENT K944845 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Dec 1994. https://www.510kdatabase.net/k945751/ 1994-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k945751-karl-storz-trocard-flexible-trocar-fda-510k.jpg K945751 - KARL STORZ TROCARD, FLEXIBLE TROCAR SLEEVES K945751 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Dec 1994. https://www.510kdatabase.net/k944973/ 1994-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k944973-nrf-system-fda-510k.jpg K944973 - NRF SYSTEM K944973 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Dec 1994. https://www.510kdatabase.net/k941978/ 1994-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k941978-high-pressure-tubing-fda-510k.jpg K941978 - HIGH PRESSURE TUBING K941978 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Laboratories. Cleared Dec 1994. https://www.510kdatabase.net/k944607/ 1994-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k944607-model-5135-auto-lpflash-fda-510k.jpg K944607 - MODEL 5135 AUTO LP/FLASH K944607 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Dec 1994. https://www.510kdatabase.net/k933467/ 1994-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k933467-prn-adapter-fda-510k.jpg K933467 - PRN ADAPTER K933467 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Dec 1994. https://www.510kdatabase.net/k935773/ 1994-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k935773-exactech-porous-coated-posterior-fda-510k.jpg K935773 - EXACTECH POROUS COATED POSTERIOR STABILIZED FEMORAL COMPONENT K935773 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Dec 1994. https://www.510kdatabase.net/k944182/ 1994-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k944182-powder-free-medical-glove-fda-510k.jpg K944182 - POWDER FREE MEDICAL GLOVE K944182 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Dec 1994. https://www.510kdatabase.net/k944184/ 1994-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k944184-synthetic-medical-gloves-fda-510k.jpg K944184 - SYNTHETIC MEDICAL GLOVES K944184 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Dec 1994. https://www.510kdatabase.net/k944213/ 1994-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k944213-62-vitallium-alloy-cancellous-bone-screw-fda-510k.jpg K944213 - 6.2 VITALLIUM ALLOY CANCELLOUS BONE SCREW K944213 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Dec 1994. https://www.510kdatabase.net/k944229/ 1994-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k944229-olympus-amylase-reagent-fda-510k.jpg K944229 - OLYMPUS AMYLASE REAGENT K944229 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus America, Inc.. Cleared Dec 1994. https://www.510kdatabase.net/k944460/ 1994-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k944460-datascope-intra-aortic-balloon-with-fda-510k.jpg K944460 - DATASCOPE INTRA-AORTIC BALLOON WITH MODIFIED STAT GARD K944460 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Dec 1994. https://www.510kdatabase.net/k944967/ 1994-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k944967-tomo-link-fda-510k.jpg K944967 - TOMO-LINK K944967 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Dec 1994. https://www.510kdatabase.net/k945194/ 1994-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k945194-abuscreen-online-controls-fda-510k.jpg K945194 - ABUSCREEN ONLINE CONTROLS K945194 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Dec 1994. https://www.510kdatabase.net/k945195/ 1994-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k945195-abuscreen-online-propoxphene-fda-510k.jpg K945195 - ABUSCREEN ONLINE PROPOXPHENE K945195 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Dec 1994. https://www.510kdatabase.net/k945483/ 1994-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k945483-compas-fda-510k.jpg K945483 - COMPAS K945483 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Dec 1994. https://www.510kdatabase.net/k935923/ 1994-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k935923-philips-ultrasound-p800-imaging-system-fda-510k.jpg K935923 - PHILIPS ULTRASOUND P800 IMAGING SYSTEM K935923 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Dec 1994. https://www.510kdatabase.net/k941128/ 1994-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k941128-osteonics-series-7000-basic-femoral-fda-510k.jpg K941128 - OSTEONICS SERIES 7000 BASIC FEMORAL COMPONENTS K941128 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Dec 1994. https://www.510kdatabase.net/k942453/ 1994-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k942453-guide-wire-fda-510k.jpg K942453 - GUIDE WIRE K942453 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Dec 1994. https://www.510kdatabase.net/k944290/ 1994-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k944290-catheters-biliary-catheters-urological-fda-510k.jpg K944290 - CATHETERS, BILIARY CATHETERS, UROLOGICAL K944290 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Dec 1994. https://www.510kdatabase.net/k944299/ 1994-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k944299-karl-storz-insulated-biopsy-forceps-fda-510k.jpg K944299 - KARL STORZ INSULATED BIOPSY FORCEPS K944299 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Dec 1994. https://www.510kdatabase.net/k944769/ 1994-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k944769-pfc-apical-plug-fda-510k.jpg K944769 - P.F.C. APICAL PLUG K944769 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Dec 1994. https://www.510kdatabase.net/k940108/ 1994-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k940108-diagnostic-ultrasound-imaging-catheter-fda-510k.jpg K940108 - DIAGNOSTIC ULTRASOUND IMAGING CATHETER K940108 is a FDA 510(k) cleared radiology medical device. Manufacturer: Boston Scientific Corp. Cleared Dec 1994. https://www.510kdatabase.net/k943154/ 1994-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k943154-karl-stortz-obturatorsharpbluntcannulaes-fda-510k.jpg K943154 - KARL STORTZ OBTURATOR)SHARP/BLUNT)/CANNULAE/SHEATHS K943154 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Dec 1994. https://www.510kdatabase.net/k944125/ 1994-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k944125-abbott-lte-infusion-pump-fda-510k.jpg K944125 - ABBOTT LTE INFUSION PUMP K944125 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Dec 1994. https://www.510kdatabase.net/k944672/ 1994-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k944672-insurg-laptie-needle-driver-suturing-fda-510k.jpg K944672 - INSURG LAPTIE NEEDLE DRIVER SUTURING DEVICES K944672 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Boston Scientific Corp. Cleared Dec 1994. https://www.510kdatabase.net/k933461/ 1994-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k933461-boehringer-mannheim-bicarbonate-assay-fda-510k.jpg K933461 - BOEHRINGER MANNHEIM BICARBONATE ASSAY K933461 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Dec 1994. https://www.510kdatabase.net/k935169/ 1994-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k935169-aptt-es-fda-510k.jpg K935169 - APTT-ES K935169 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Dec 1994. https://www.510kdatabase.net/k942847/ 1994-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k942847-cobasr-fp-reagent-for-fda-510k.jpg K942847 - COBAS(R)-FP REAGENT FOR PROCAINAMIDE/CALIBRATOR K942847 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Dec 1994. https://www.510kdatabase.net/k943291/ 1994-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k943291-anti-ds-dna-fda-510k.jpg K943291 - ANTI DS-DNA K943291 is a FDA 510(k) cleared immunology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Dec 1994. https://www.510kdatabase.net/k944074/ 1994-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k944074-cxtm-methadonemetd-reagent-for-fda-510k.jpg K944074 - CX(TM) METHADONE(METD) REAGENT FOR SYNCHRON CX SYST K944074 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Dec 1994. https://www.510kdatabase.net/k944231/ 1994-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k944231-ontrak-testcup-collectionurinalysis-fda-510k.jpg K944231 - ONTRAK TESTCUP COLLECTION/URINALYSIS PANEL FOR COCAINE, MORPHINE AND THC K944231 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Dec 1994. https://www.510kdatabase.net/k944452/ 1994-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k944452-quantitate-electrolyte-verifier-set-fda-510k.jpg K944452 - QUANTITATE ELECTROLYTE VERIFIER SET (URINE RANGE) K944452 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Dec 1994. https://www.510kdatabase.net/k944981/ 1994-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k944981-3m-tempcare-light-cure-temporary-system-fda-510k.jpg K944981 - 3M TEMPCARE LIGHT CURE TEMPORARY SYSTEM K944981 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Dec 1994. https://www.510kdatabase.net/k942338/ 1994-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k942338-olympus-pf-8p-oes-pancreato-fiberscope-fda-510k.jpg K942338 - OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIES K942338 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Corp.. Cleared Nov 1994. https://www.510kdatabase.net/k944087/ 1994-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k944087-cxtm-cocaine-metabolitecocm-fda-510k.jpg K944087 - CX(TM) COCAINE METABOLITE(COCM) REAGENT/SYNCHRON CX SYS K944087 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Nov 1994. https://www.510kdatabase.net/k944987/ 1994-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k944987-uro-elite-table-accessories-fda-510k.jpg K944987 - URO - ELITE TABLE ACCESSORIES K944987 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Nov 1994. https://www.510kdatabase.net/k941223/ 1994-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k941223-advance-analysis-software-fda-510k.jpg K941223 - ADVANCE ANALYSIS SOFTWARE K941223 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Nov 1994. https://www.510kdatabase.net/k944201/ 1994-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k944201-hi-q-hand-instruments-urology-fda-510k.jpg K944201 - HI-Q HAND INSTRUMENTS- UROLOGY K944201 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Olympus America, Inc.. Cleared Nov 1994. https://www.510kdatabase.net/k940189/ 1994-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k940189-coil-positioner-set-fda-510k.jpg K940189 - COIL POSITIONER SET K940189 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Nov 1994. https://www.510kdatabase.net/k940661/ 1994-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k940661-stiegmann-goff-endoscopic-ligator-fda-510k.jpg K940661 - STIEGMANN-GOFF ENDOSCOPIC LIGATOR K940661 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 1994. https://www.510kdatabase.net/k943447/ 1994-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k943447-v-max-options-fda-510k.jpg K943447 - V-MAX OPTIONS K943447 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Nov 1994. https://www.510kdatabase.net/k943595/ 1994-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k943595-serumurine-appli-ilabtm-clinical-fda-510k.jpg K943595 - SERUM/URINE APPLI ILAB(TM) CLINICAL CHEMISTRY SYSTEM K943595 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Nov 1994. https://www.510kdatabase.net/k943722/ 1994-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k943722-chemotherapy-sharps-disposal-containers-fda-510k.jpg K943722 - CHEMOTHERAPY SHARPS DISPOSAL CONTAINERS K943722 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Nov 1994. https://www.510kdatabase.net/k943926/ 1994-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k943926-rapido-2000-automatic-radiographic-table-fda-510k.jpg K943926 - RAPIDO 2000 AUTOMATIC RADIOGRAPHIC TABLE K943926 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Nov 1994. https://www.510kdatabase.net/k944883/ 1994-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k944883-gamma-locking-nail-long-length-fda-510k.jpg K944883 - GAMMA LOCKING NAIL - LONG LENGTH K944883 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Nov 1994. https://www.510kdatabase.net/k945457/ 1994-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k945457-trocar-accesory-fda-510k.jpg K945457 - TROCAR ( ACCESORY) K945457 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Nov 1994. https://www.510kdatabase.net/k940287/ 1994-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k940287-meniscal-suture-instrumentarium-fda-510k.jpg K940287 - MENISCAL SUTURE INSTRUMENTARIUM K940287 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Nov 1994. https://www.510kdatabase.net/k944298/ 1994-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k944298-karl-storz-insulated-scissors-fda-510k.jpg K944298 - KARL STORZ INSULATED SCISSORS K944298 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Nov 1994. https://www.510kdatabase.net/k944453/ 1994-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k944453-quantitate-uric-acid-verifier-set-fda-510k.jpg K944453 - QUANTITATE URIC ACID VERIFIER SET K944453 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Nov 1994. https://www.510kdatabase.net/k944797/ 1994-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k944797-karl-storz-insulated-cannulae-suction-fda-510k.jpg K944797 - KARL STORZ INSULATED CANNULAE, SUCTION TUBES K944797 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Nov 1994. https://www.510kdatabase.net/k941872/ 1994-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k941872-specialty-assayed-control-2-cat-no-5302-fda-510k.jpg K941872 - SPECIALTY ASSAYED CONTROL-2 CAT. NO. 5302 K941872 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Nov 1994. https://www.510kdatabase.net/k944076/ 1994-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k944076-cxtm-benzodiazepinebenz-reagent-for-fda-510k.jpg K944076 - CX(TM) BENZODIAZEPINE(BENZ) REAGENT FOR SYCHRON CX SYS K944076 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Nov 1994. https://www.510kdatabase.net/k944088/ 1994-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k944088-cxtm-cannabinoid-100-ngthc-fda-510k.jpg K944088 - CX(TM) CANNABINOID 100 NG(THC) REAGENT/SYNCHRON CX SYS K944088 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Nov 1994. https://www.510kdatabase.net/k943721/ 1994-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k943721-otoview-telescopic-otoscopes-fda-510k.jpg K943721 - OTOVIEW TELESCOPIC OTOSCOPES K943721 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Nov 1994. https://www.510kdatabase.net/k943550/ 1994-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k943550-gentamicin-fpia-reagent-set-and-fda-510k.jpg K943550 - GENTAMICIN FPIA REAGENT SET AND CALIBRATORS K943550 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Nov 1994. https://www.510kdatabase.net/k944891/ 1994-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k944891-sas-quant-hcg-urine-fda-510k.jpg K944891 - SAS QUANT HCG URINE K944891 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sa Scientific, Inc.. Cleared Nov 1994. https://www.510kdatabase.net/k945380/ 1994-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k945380-karl-storz-monopolar-high-frequency-fda-510k.jpg K945380 - KARL STORZ MONOPOLAR HIGH FREQUENCY CORDS K945380 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Nov 1994. https://www.510kdatabase.net/k943500/ 1994-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k943500-emit-2000-digoxin-assay-fda-510k.jpg K943500 - EMIT 2000 DIGOXIN ASSAY K943500 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Nov 1994. https://www.510kdatabase.net/k932414/ 1994-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k932414-continuous-cardiac-output-system-fda-510k.jpg K932414 - CONTINUOUS CARDIAC OUTPUT SYSTEM K932414 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1994. https://www.510kdatabase.net/k941285/ 1994-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k941285-arthrex-graft-harvesting-kit-fda-510k.jpg K941285 - ARTHREX GRAFT HARVESTING KIT K941285 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Nov 1994. https://www.510kdatabase.net/k944081/ 1994-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k944081-olympus-switching-unit-model-su-1-fda-510k.jpg K944081 - OLYMPUS SWITCHING UNIT MODEL SU-1 K944081 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus America, Inc.. Cleared Nov 1994. https://www.510kdatabase.net/k944202/ 1994-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k944202-abbott-a-gent-liquid-magnesium-reagent-fda-510k.jpg K944202 - ABBOTT A-GENT LIQUID MAGNESIUM REAGENT, MODIFIED K944202 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1994. https://www.510kdatabase.net/k944821/ 1994-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k944821-model-5151-fda-510k.jpg K944821 - MODEL 5151 K944821 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Nov 1994. https://www.510kdatabase.net/k945109/ 1994-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k945109-monoject-bone-marrow-biopsy-trays-fda-510k.jpg K945109 - MONOJECT BONE MARROW BIOPSY TRAYS K945109 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sherwood Medical Co.. Cleared Nov 1994. https://www.510kdatabase.net/k935162/ 1994-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k935162-rep-direct-sep-cholesterol-15-kit-fda-510k.jpg K935162 - REP DIRECT-SEP CHOLESTEROL-15 KIT K935162 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Nov 1994. https://www.510kdatabase.net/k940713/ 1994-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k940713-pca-modular-primaryrevision-patella-fda-510k.jpg K940713 - PCA MODULAR PRIMARY/REVISION PATELLA K940713 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Nov 1994. https://www.510kdatabase.net/k942370/ 1994-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k942370-depuy-cemented-hip-prosthesis-fda-510k.jpg K942370 - DEPUY CEMENTED HIP PROSTHESIS K942370 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Nov 1994. https://www.510kdatabase.net/k942451/ 1994-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k942451-bio-rad-clinical-data-management-system-fda-510k.jpg K942451 - BIO-RAD CLINICAL DATA MANAGEMENT SYSTEM K942451 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Nov 1994. https://www.510kdatabase.net/k943866/ 1994-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k943866-valproic-acid-fpia-reagent-set-and-fda-510k.jpg K943866 - VALPROIC ACID FPIA REAGENT SET AND CALIBRATORS K943866 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Nov 1994. https://www.510kdatabase.net/k944063/ 1994-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k944063-fluorescence-polarization-immunoassay-fda-510k.jpg K944063 - FLUORESCENCE POLARIZATION IMMUNOASSAY CARBAMAZEPINE K944063 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Nov 1994. https://www.510kdatabase.net/k944093/ 1994-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k944093-dimensionr-xl-clinical-chemistry-system-fda-510k.jpg K944093 - DIMENSION(R) XL CLINICAL CHEMISTRY SYSTEM K944093 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Nov 1994. https://www.510kdatabase.net/k944371/ 1994-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k944371-tobramycin-fpia-reagent-set-and-fda-510k.jpg K944371 - TOBRAMYCIN FPIA REAGENT SET AND CALIBRATOR K944371 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Nov 1994. https://www.510kdatabase.net/k944566/ 1994-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k944566-vacutainer-brand-plus-sodium-heparin-fda-510k.jpg K944566 - VACUTAINER BRAND PLUS SODIUM HEPARIN TUBE K944566 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Nov 1994. https://www.510kdatabase.net/k944955/ 1994-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k944955-aesculap-thoracoscopic-instruments-fda-510k.jpg K944955 - AESCULAP THORACOSCOPIC INSTRUMENTS K944955 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Aesculap, Inc.. Cleared Nov 1994. https://www.510kdatabase.net/k945059/ 1994-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k945059-karl-storz-suctionirrigation-tubes-fda-510k.jpg K945059 - KARL STORZ SUCTION/IRRIGATION TUBES. CANNULAE, SHEATHS K945059 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Nov 1994. https://www.510kdatabase.net/k945101/ 1994-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k945101-karl-storz-retractors-probes-fda-510k.jpg K945101 - KARL STORZ RETRACTORS, PROBES, DISSECTORS, HOOKD K945101 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Nov 1994. https://www.510kdatabase.net/k934756/ 1994-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k934756-codman-anterior-cervical-spine-plate-fda-510k.jpg K934756 - CODMAN ANTERIOR CERVICAL SPINE PLATE SYSTEM K934756 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Nov 1994. https://www.510kdatabase.net/k940960/ 1994-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k940960-suction-and-irrigation-tubes-fda-510k.jpg K940960 - SUCTION AND IRRIGATION TUBES K940960 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Nov 1994. https://www.510kdatabase.net/k943592/ 1994-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k943592-chemstrip-mini-ua-urine-analyzer-fda-510k.jpg K943592 - CHEMSTRIP MINI UA URINE ANALYZER K943592 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Nov 1994. https://www.510kdatabase.net/k931267/ 1994-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k931267-convertors-iso-bac-drape-material-fda-510k.jpg K931267 - CONVERTORS ISO BAC DRAPE MATERIAL K931267 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Nov 1994. https://www.510kdatabase.net/k940541/ 1994-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k940541-magnetic-resonance-diag-device-fda-510k.jpg K940541 - MAGNETIC RESONANCE DIAG DEVICE MAGNETOM VISION (MODIF) K940541 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 1994. https://www.510kdatabase.net/k941896/ 1994-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k941896-steadman-ligament-graft-passer-and-fda-510k.jpg K941896 - STEADMAN LIGAMENT GRAFT PASSER AND PROTECTOR K941896 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Nov 1994. https://www.510kdatabase.net/k942400/ 1994-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k942400-bard-peripheral-balloon-dilatation-fda-510k.jpg K942400 - BARD PERIPHERAL BALLOON DILATATION CATHETER K942400 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 1994. https://www.510kdatabase.net/k943355/ 1994-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k943355-gemnet-fda-510k.jpg K943355 - GEMNET K943355 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Nov 1994. https://www.510kdatabase.net/k944588/ 1994-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k944588-sterile-plastic-dressing-fda-510k.jpg K944588 - STERILE PLASTIC DRESSING K944588 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Nov 1994. https://www.510kdatabase.net/k933694/ 1994-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k933694-sigma-glucose-reagent-fda-510k.jpg K933694 - SIGMA GLUCOSE REAGENT K933694 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Nov 1994. https://www.510kdatabase.net/k940703/ 1994-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k940703-medtronic-model-4558m-fda-510k.jpg K940703 - MEDTRONIC MODEL 4558M K940703 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Nov 1994. https://www.510kdatabase.net/k944959/ 1994-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k944959-amplatz-super-stiff-guidewire-fda-510k.jpg K944959 - AMPLATZ SUPER STIFF GUIDEWIRE K944959 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Nov 1994. https://www.510kdatabase.net/k940790/ 1994-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k940790-babcockbowel-clamp-forceps-fda-510k.jpg K940790 - BABCOCK/BOWEL CLAMP FORCEPS K940790 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Nov 1994. https://www.510kdatabase.net/k943664/ 1994-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k943664-intermate-xlv-elastomeric-infusion-fda-510k.jpg K943664 - INTERMATE XLV ELASTOMERIC INFUSION SYSTEM K943664 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Nov 1994. https://www.510kdatabase.net/k943776/ 1994-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k943776-coagulator-cutter-endoscopic-bipolar-fda-510k.jpg K943776 - COAGULATOR CUTTER, ENDOSCOPIC BIPOLAR AND ACCESSORIES K943776 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Nov 1994. https://www.510kdatabase.net/k942301/ 1994-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k942301-microvasive-injection-gold-probe-fda-510k.jpg K942301 - MICROVASIVE INJECTION GOLD PROBE K942301 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Nov 1994. https://www.510kdatabase.net/k943400/ 1994-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k943400-sas-salmonella-h-d-antiserum-fda-510k.jpg K943400 - SAS SALMONELLA H D ANTISERUM K943400 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sa Scientific, Inc.. Cleared Nov 1994. https://www.510kdatabase.net/k944796/ 1994-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k944796-karl-storz-monopolar-coagulating-nedle-fda-510k.jpg K944796 - KARL STORZ MONOPOLAR COAGULATING, NEDLE ELECTRODES K944796 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Nov 1994. https://www.510kdatabase.net/k941750/ 1994-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k941750-proposed-trademan-microvasive-fda-510k.jpg K941750 - PROPOSED TRADEMAN MICROVASIVE POLYPECTOMY SNARES K941750 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Nov 1994. https://www.510kdatabase.net/k942094/ 1994-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k942094-cordis-savvy-pta-balloon-catheter-fda-510k.jpg K942094 - CORDIS SAVVY PTA BALLOON CATHETER K942094 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Nov 1994. https://www.510kdatabase.net/k933086/ 1994-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k933086-afsc-hemo-control-5331-aa2-hemo-fda-510k.jpg K933086 - AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328 K933086 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Oct 1994. https://www.510kdatabase.net/k941573/ 1994-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k941573-roche-reagent-fda-510k.jpg K941573 - ROCHE REAGENT K941573 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Oct 1994. https://www.510kdatabase.net/k941797/ 1994-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k941797-immulite-shbg-fda-510k.jpg K941797 - IMMULITE SHBG K941797 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Oct 1994. https://www.510kdatabase.net/k943300/ 1994-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k943300-depuy-porous-coated-global-shoulder-fda-510k.jpg K943300 - DEPUY POROUS COATED GLOBAL SHOULDER K943300 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Oct 1994. https://www.510kdatabase.net/k943705/ 1994-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k943705-folic-acid-fda-510k.jpg K943705 - FOLIC ACID K943705 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Oct 1994. https://www.510kdatabase.net/k943780/ 1994-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k943780-negative-control-strips-for-urinalysis-fda-510k.jpg K943780 - NEGATIVE CONTROL STRIPS FOR URINALYSIS (CHEX-STIX, CLINITEK AUTO 2000, CLINITEX ATLAS) K943780 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Oct 1994. https://www.510kdatabase.net/k945134/ 1994-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k945134-portable-patient-monitor-fda-510k.jpg K945134 - PORTABLE PATIENT MONITOR K945134 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Oct 1994. https://www.510kdatabase.net/k941291/ 1994-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k941291-monoject-samplette-separator-tube-fda-510k.jpg K941291 - MONOJECT SAMPLETTE SEPARATOR TUBE K941291 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sherwood Medical Co.. Cleared Oct 1994. https://www.510kdatabase.net/k943235/ 1994-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k943235-immulite-digitoxin-fda-510k.jpg K943235 - IMMULITE DIGITOXIN K943235 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Oct 1994. https://www.510kdatabase.net/k943313/ 1994-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k943313-phenytoin-fpia-reagent-set-and-fda-510k.jpg K943313 - PHENYTOIN FPIA REAGENT SET AND CALIBRATORS K943313 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Oct 1994. https://www.510kdatabase.net/k943076/ 1994-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k943076-quanta-lite-ena-5-elisa-kit-fda-510k.jpg K943076 - QUANTA LITE ENA 5 ELISA KIT K943076 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Oct 1994. https://www.510kdatabase.net/k932776/ 1994-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k932776-cruciate-retaining-cemented-tibial-fda-510k.jpg K932776 - CRUCIATE RETAINING CEMENTED TIBIAL COMPONENTS K932776 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Oct 1994. https://www.510kdatabase.net/k933743/ 1994-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k933743-ssa-380a-fda-510k.jpg K933743 - SSA-380A K933743 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Oct 1994. https://www.510kdatabase.net/k935726/ 1994-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k935726-exactech-porous-coated-cruciate-fda-510k.jpg K935726 - EXACTECH POROUS COATED CRUCIATE RETAINED FEMORAL COMPONENT K935726 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Oct 1994. https://www.510kdatabase.net/k942328/ 1994-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k942328-n-latex-rf-fda-510k.jpg K942328 - N LATEX RF K942328 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Oct 1994. https://www.510kdatabase.net/k942610/ 1994-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k942610-kodak-extachem-clinical-chemistry-fda-510k.jpg K942610 - KODAK EXTACHEM CLINICAL CHEMISTRY SLIDE DIGOXIN (DGXN) K942610 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Oct 1994. https://www.510kdatabase.net/k943539/ 1994-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k943539-aims-cannulated-acl-screw-fda-510k.jpg K943539 - AIMS CANNULATED ACL SCREW K943539 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 1994. https://www.510kdatabase.net/k943586/ 1994-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k943586-zirconia-ceramic-modular-heads-astro-met-fda-510k.jpg K943586 - ZIRCONIA CERAMIC MODULAR HEADS (ASTRO MET) K943586 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Oct 1994. https://www.510kdatabase.net/k925613/ 1994-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k925613-proximal-humeral-replacement-system-fda-510k.jpg K925613 - PROXIMAL HUMERAL REPLACEMENT SYSTEM K925613 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Oct 1994. https://www.510kdatabase.net/k933942/ 1994-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k933942-solution-bowed-femoral-hip-protsthesis-fda-510k.jpg K933942 - SOLUTION BOWED FEMORAL HIP PROTSTHESIS K933942 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Oct 1994. https://www.510kdatabase.net/k936232/ 1994-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k936232-bscca-model-930-iab-bscca-30-sidewinder-fda-510k.jpg K936232 - BSC/CA MODEL 930 IAB, BSC/CA 30 SIDEWINDER K936232 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Oct 1994. https://www.510kdatabase.net/k940982/ 1994-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k940982-arterial-embolization-device-krd-fda-510k.jpg K940982 - ARTERIAL EMBOLIZATION DEVICE (KRD) K940982 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Oct 1994. https://www.510kdatabase.net/k941606/ 1994-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k941606-preservation-unicompartmental-knee-fda-510k.jpg K941606 - PRESERVATION UNICOMPARTMENTAL KNEE K941606 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Oct 1994. https://www.510kdatabase.net/k942966/ 1994-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k942966-aml-trilock-replacement-liner-system-fda-510k.jpg K942966 - AML TRILOCK REPLACEMENT LINER SYSTEM K942966 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Oct 1994. https://www.510kdatabase.net/k943302/ 1994-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k943302-aml-tri-lock-replacement-liner-system-fda-510k.jpg K943302 - AML TRI-LOCK REPLACEMENT LINER SYSTEM K943302 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Oct 1994. https://www.510kdatabase.net/k943575/ 1994-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k943575-b-d-guardian-nestable-sharps-collectors-fda-510k.jpg K943575 - B-D GUARDIAN NESTABLE SHARPS COLLECTORS K943575 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1994. https://www.510kdatabase.net/k944296/ 1994-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k944296-karl-storz-optical-video-tongue-fda-510k.jpg K944296 - KARL STORZ OPTICAL VIDEO TONGUE DEPRESSOR K944296 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Oct 1994. https://www.510kdatabase.net/k934070/ 1994-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k934070-tina-quant-hemoglobin-a1c-fda-510k.jpg K934070 - TINA-QUANT HEMOGLOBIN A1C K934070 is a FDA 510(k) cleared hematology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Oct 1994. https://www.510kdatabase.net/k935295/ 1994-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k935295-alta-femoral-intramedullary-rodscfx-fda-510k.jpg K935295 - ALTA FEMORAL INTRAMEDULLARY RODS/CFX RODS MODIFICATION K935295 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Oct 1994. https://www.510kdatabase.net/k943665/ 1994-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k943665-nasal-endoscopy-sinuscopy-hand-fda-510k.jpg K943665 - NASAL ENDOSCOPY & SINUSCOPY HAND INSTRUMENTS K943665 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Olympus America, Inc.. Cleared Oct 1994. https://www.510kdatabase.net/k941737/ 1994-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k941737-specialty-assayed-control-1-fda-510k.jpg K941737 - SPECIALTY ASSAYED CONTROL-1 K941737 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Oct 1994. https://www.510kdatabase.net/k944530/ 1994-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k944530-karl-storz-insulated-scissors-and-fda-510k.jpg K944530 - KARL STORZ INSULATED SCISSORS AND RECTAL SNARES K944530 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Oct 1994. https://www.510kdatabase.net/k944754/ 1994-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k944754-amplatz-super-stiff-guidewire-fda-510k.jpg K944754 - AMPLATZ SUPER STIFF GUIDEWIRE K944754 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Oct 1994. https://www.510kdatabase.net/k940235/ 1994-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k940235-ortholoc-advantim-ps-lsi-tibial-insert-fda-510k.jpg K940235 - ORTHOLOC ADVANTIM PS LSI TIBIAL INSERT K940235 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Oct 1994. https://www.510kdatabase.net/k942048/ 1994-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k942048-roche-ammonia-various-fda-510k.jpg K942048 - ROCHE AMMONIA (VARIOUS) K942048 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Oct 1994. https://www.510kdatabase.net/k942364/ 1994-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k942364-hitachi-914-analyzer-fda-510k.jpg K942364 - HITACHI 914 ANALYZER K942364 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Oct 1994. https://www.510kdatabase.net/k943054/ 1994-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k943054-osteonics-secure-fit-ad-acetabular-fda-510k.jpg K943054 - OSTEONICS SECURE-FIT AD ACETABULAR COMPONENT SYSTEM K943054 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Oct 1994. https://www.510kdatabase.net/k944295/ 1994-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k944295-karl-storz-laryngoscope-accessories-fda-510k.jpg K944295 - KARL STORZ LARYNGOSCOPE ACCESSORIES K944295 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Oct 1994. https://www.510kdatabase.net/k944608/ 1994-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k944608-hp-m1722ab-and-m1723ab-codemaster-fda-510k.jpg K944608 - HP M1722A/B AND M1723A/B CODEMASTER K944608 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Oct 1994. https://www.510kdatabase.net/k943997/ 1994-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k943997-behring-nephelometer-ii-fda-510k.jpg K943997 - BEHRING NEPHELOMETER II K943997 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Oct 1994. https://www.510kdatabase.net/k944375/ 1994-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k944375-nt-rheumatology-control-sl1-sl2-fda-510k.jpg K944375 - N/T RHEUMATOLOGY CONTROL SL/1, SL/2 K944375 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Oct 1994. https://www.510kdatabase.net/k944467/ 1994-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k944467-aesculap-manual-laparoscopic-instruments-fda-510k.jpg K944467 - AESCULAP MANUAL LAPAROSCOPIC INSTRUMENTS K944467 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Oct 1994. https://www.510kdatabase.net/k926568/ 1994-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k926568-baxter-ct-dialyzer-fda-510k.jpg K926568 - BAXTER CT DIALYZER K926568 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Sep 1994. https://www.510kdatabase.net/k941814/ 1994-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k941814-argyle-dual-lumen-umbilical-vessel-fda-510k.jpg K941814 - ARGYLE DUAL LUMEN UMBILICAL VESSEL CATHETER K941814 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Sep 1994. https://www.510kdatabase.net/k943634/ 1994-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k943634-hp-77010cf-fda-510k.jpg K943634 - HP 77010CF K943634 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Sep 1994. https://www.510kdatabase.net/k922452/ 1994-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k922452-gore-tex-soft-tissue-patch-plus-fda-510k.jpg K922452 - GORE-TEX SOFT TISSUE PATCH PLUS K922452 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Sep 1994. https://www.510kdatabase.net/k941619/ 1994-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k941619-lorenz-surgical-threaded-dental-implant-fda-510k.jpg K941619 - LORENZ SURGICAL THREADED DENTAL IMPLANT K941619 is a FDA 510(k) cleared dental medical device. Manufacturer: Biomet, Inc.. Cleared Sep 1994. https://www.510kdatabase.net/k941620/ 1994-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k941620-lorenz-surgical-cylinder-dental-implant-fda-510k.jpg K941620 - LORENZ SURGICAL CYLINDER DENTAL IMPLANT K941620 is a FDA 510(k) cleared dental medical device. Manufacturer: Biomet, Inc.. Cleared Sep 1994. https://www.510kdatabase.net/k941621/ 1994-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k941621-lorenz-surgical-finned-dental-implant-fda-510k.jpg K941621 - LORENZ SURGICAL FINNED DENTAL IMPLANT K941621 is a FDA 510(k) cleared dental medical device. Manufacturer: Biomet, Inc.. Cleared Sep 1994. https://www.510kdatabase.net/k930623/ 1994-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k930623-microvasive-insurg-biliary-balloon-fda-510k.jpg K930623 - MICROVASIVE INSURG BILIARY BALLOON DILATITION CATH K930623 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Sep 1994. https://www.510kdatabase.net/k941036/ 1994-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k941036-curved-rotatable-disposable-fda-510k.jpg K941036 - CURVED ROTATABLE DISPOSABLE ARTHROSCOPIC SURGERY BLADES K941036 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Sep 1994. https://www.510kdatabase.net/k941141/ 1994-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k941141-precision-ostelock-sp-femoral-component-fda-510k.jpg K941141 - PRECISION OSTELOCK SP FEMORAL COMPONENT K941141 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Sep 1994. https://www.510kdatabase.net/k942115/ 1994-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k942115-infinity-revision-hip-stem-fda-510k.jpg K942115 - INFINITY REVISION HIP STEM K942115 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Sep 1994. https://www.510kdatabase.net/k930786/ 1994-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k930786-epcor-fda-510k.jpg K930786 - EPCOR K930786 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 1994. https://www.510kdatabase.net/k936001/ 1994-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k936001-patlak-fdg-autoradiographic-fda-510k.jpg K936001 - PATLAK & FDG AUTORADIOGRAPHIC K936001 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Sep 1994. https://www.510kdatabase.net/k942146/ 1994-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k942146-phoenix-nuclear-medicine-processing-fda-510k.jpg K942146 - PHOENIX NUCLEAR MEDICINE PROCESSING COMPUTER K942146 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 1994. https://www.510kdatabase.net/k943805/ 1994-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k943805-prestige-remote-r-f-system-models-h-vh-fda-510k.jpg K943805 - PRESTIGE REMOTE R & F SYSTEM MODELS H, VH & VHD K943805 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Sep 1994. https://www.510kdatabase.net/k932141/ 1994-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k932141-cardiac-catheterization-kit-fda-510k.jpg K932141 - CARDIAC CATHETERIZATION KIT K932141 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1994. https://www.510kdatabase.net/k934041/ 1994-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k934041-hewlett-packard-conos-ultrasound-fda-510k.jpg K934041 - HEWLETT PACKARD CONOS ULTRASOUND IMAGING SYSTEM MODIFICATION K934041 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Sep 1994. https://www.510kdatabase.net/k943584/ 1994-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k943584-presterilized-endodontic-files-fda-510k.jpg K943584 - PRESTERILIZED ENDODONTIC FILES K943584 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Sep 1994. https://www.510kdatabase.net/k943668/ 1994-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k943668-ksea-continous-flow-cystoscope-fda-510k.jpg K943668 - KSEA CONTINOUS FLOW CYSTOSCOPE K943668 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Sep 1994. https://www.510kdatabase.net/k940983/ 1994-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k940983-the-karl-storz-uromattm-fda-510k.jpg K940983 - THE KARL STORZ UROMAT(TM) K940983 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Sep 1994. https://www.510kdatabase.net/k942060/ 1994-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k942060-pfc-cement-restrictor-fda-510k.jpg K942060 - P.F.C. CEMENT RESTRICTOR K942060 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Sep 1994. https://www.510kdatabase.net/k942479/ 1994-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k942479-integral-co-cr-femoral-component-fda-510k.jpg K942479 - INTEGRAL CO-CR FEMORAL COMPONENT K942479 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Sep 1994. https://www.510kdatabase.net/k942619/ 1994-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k942619-emit-2000-digoxin-assaycalibrators-fda-510k.jpg K942619 - EMIT 2000 DIGOXIN ASSAY/CALIBRATORS K942619 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Sep 1994. https://www.510kdatabase.net/k942809/ 1994-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k942809-acetabular-dome-hole-plugs-fda-510k.jpg K942809 - ACETABULAR DOME HOLE PLUGS K942809 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Sep 1994. https://www.510kdatabase.net/k944224/ 1994-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k944224-karl-storz-fluid-light-cables-fda-510k.jpg K944224 - KARL STORZ FLUID LIGHT CABLES K944224 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Sep 1994. https://www.510kdatabase.net/k944249/ 1994-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k944249-auto-suture-anti-fog-device-fda-510k.jpg K944249 - AUTO SUTURE* ANTI-FOG DEVICE** K944249 is a FDA 510(k) cleared general hospital medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Sep 1994. https://www.510kdatabase.net/k941443/ 1994-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k941443-synergy-quad-fda-510k.jpg K941443 - SYNERGY QUAD K941443 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Sep 1994. https://www.510kdatabase.net/k941444/ 1994-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k941444-bhi-agar-with-vancomycin-fda-510k.jpg K941444 - BHI AGAR WITH VANCOMYCIN K941444 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Sep 1994. https://www.510kdatabase.net/k942027/ 1994-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k942027-impact-co-cr-1-piece-femoral-component-fda-510k.jpg K942027 - IMPACT CO-CR 1-PIECE FEMORAL COMPONENT K942027 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Sep 1994. https://www.510kdatabase.net/k942028/ 1994-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k942028-rx90-femoral-component-fda-510k.jpg K942028 - RX90 FEMORAL COMPONENT K942028 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Sep 1994. https://www.510kdatabase.net/k935277/ 1994-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k935277-karl-storz-hopkins-ksh-i-rigid-fda-510k.jpg K935277 - KARL STORZ HOPKINS (KSH) I RIGID TELESCOPE, KSH II RIGID TELESCOPE, KSH RIGID OPERATING SCOPES KARL STORZ OVAL SHEATH K935277 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Sep 1994. https://www.510kdatabase.net/k940206/ 1994-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k940206-bard-urine-collection-products-fda-510k.jpg K940206 - BARD URINE COLLECTION PRODUCTS MODIFICATION K940206 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Sep 1994. https://www.510kdatabase.net/k942786/ 1994-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k942786-karl-storz-laser-accessories-fda-510k.jpg K942786 - KARL STORZ LASER ACCESSORIES K942786 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Sep 1994. https://www.510kdatabase.net/k943340/ 1994-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k943340-cordis-steerable-guidewire-fda-510k.jpg K943340 - CORDIS STEERABLE GUIDEWIRE K943340 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Sep 1994. https://www.510kdatabase.net/k932106/ 1994-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k932106-mobilett-plus-mobile-x-ray-system-fda-510k.jpg K932106 - MOBILETT PLUS MOBILE X-RAY SYSTEM K932106 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 1994. https://www.510kdatabase.net/k932672/ 1994-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k932672-mammomat-300-and-mammomat-3000-fda-510k.jpg K932672 - MAMMOMAT 300 AND MAMMOMAT 3000 K932672 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 1994. https://www.510kdatabase.net/k940961/ 1994-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k940961-monoject-luer-adapter-fda-510k.jpg K940961 - MONOJECT LUER ADAPTER K940961 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Sep 1994. https://www.510kdatabase.net/k941860/ 1994-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k941860-specialty-assayed-reference-plasma-sarp-fda-510k.jpg K941860 - SPECIALTY ASSAYED REFERENCE PLASMA (S.A.R.P.) K941860 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Sep 1994. https://www.510kdatabase.net/k940231/ 1994-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k940231-intra-aortic-balloon-for-optional-fda-510k.jpg K940231 - INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION K940231 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Sep 1994. https://www.510kdatabase.net/k935279/ 1994-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k935279-karl-storz-hopkins-i-rigid-fda-510k.jpg K935279 - KARL STORZ HOPKINS I RIGID AUTOCLAVABLE TELESCOPE, KARL STORZ HOPKINS II RIGID AUTOCLAVABLE TELESCOPE K935279 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Sep 1994. https://www.510kdatabase.net/k940736/ 1994-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k940736-haig-nail-fda-510k.jpg K940736 - HAIG NAIL K940736 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Sep 1994. https://www.510kdatabase.net/k941853/ 1994-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k941853-passport-fda-510k.jpg K941853 - PASSPORT K941853 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Sep 1994. https://www.510kdatabase.net/k940594/ 1994-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k940594-karl-storz-adult-pediatric-nephroscope-fda-510k.jpg K940594 - KARL STORZ ADULT & PEDIATRIC NEPHROSCOPE K940594 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Sep 1994. https://www.510kdatabase.net/k940679/ 1994-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k940679-rep-hdlldl-30-kit-cat-no-322032213222-fda-510k.jpg K940679 - REP HDL/LDL-30 KIT - CAT. NO. 3220,3221,3222 K940679 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Sep 1994. https://www.510kdatabase.net/k943485/ 1994-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k943485-monoject-horizontal-entry-sharps-fda-510k.jpg K943485 - MONOJECT HORIZONTAL ENTRY SHARPS CONTAINER K943485 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Sep 1994. https://www.510kdatabase.net/k943755/ 1994-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k943755-solder-aurolite-cb-fda-510k.jpg K943755 - SOLDER AUROLITE CB K943755 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Sep 1994. https://www.510kdatabase.net/k943757/ 1994-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k943757-solder-aurolite-repair-fda-510k.jpg K943757 - SOLDER AUROLITE REPAIR K943757 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Sep 1994. https://www.510kdatabase.net/k935163/ 1994-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k935163-continuous-irrigation-cystourethroscope-fda-510k.jpg K935163 - CONTINUOUS IRRIGATION CYSTOURETHROSCOPE K935163 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Sep 1994. https://www.510kdatabase.net/k935737/ 1994-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k935737-stone-extractor-grasping-forceps-fda-510k.jpg K935737 - STONE EXTRACTOR, GRASPING FORCEPS K935737 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Sep 1994. https://www.510kdatabase.net/k936079/ 1994-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k936079-ecactech-porous-coated-finned-tibial-fda-510k.jpg K936079 - ECACTECH POROUS COATED FINNED TIBIAL TRAY COMPNENT K936079 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Sep 1994. https://www.510kdatabase.net/k940427/ 1994-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k940427-karl-storz-thoracic-surgery-instruments-fda-510k.jpg K940427 - KARL STORZ THORACIC SURGERY INSTRUMENTS K940427 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Sep 1994. https://www.510kdatabase.net/k942638/ 1994-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k942638-simultrac-lhfsh-radioummunoassay-kit-fda-510k.jpg K942638 - SIMULTRAC LH/FSH RADIOUMMUNOASSAY KIT K942638 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1994. https://www.510kdatabase.net/k934704/ 1994-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k934704-auto-suture-disposable-endoscope-sheath-fda-510k.jpg K934704 - AUTO SUTURE DISPOSABLE ENDOSCOPE SHEATH K934704 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Sep 1994. https://www.510kdatabase.net/k942114/ 1994-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k942114-roche-tdm-calibration-verification-fda-510k.jpg K942114 - ROCHE TDM CALIBRATION VERIFICATION TEST SET K942114 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Sep 1994. https://www.510kdatabase.net/k943838/ 1994-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k943838-argesol-760-fda-510k.jpg K943838 - ARGESOL #760 K943838 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Sep 1994. https://www.510kdatabase.net/k930275/ 1994-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k930275-precision-osteolock-acetabular-component-fda-510k.jpg K930275 - PRECISION OSTEOLOCK ACETABULAR COMPONENT K930275 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Sep 1994. https://www.510kdatabase.net/k933290/ 1994-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k933290-ortholoc-advantim-fda-510k.jpg K933290 - ORTHOLOC ADVANTIM K933290 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Sep 1994. https://www.510kdatabase.net/k934620/ 1994-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k934620-ortholoc-advantim-fixed-stem-non-fda-510k.jpg K934620 - ORTHOLOC ADVANTIM FIXED STEM NON-POROUS TIBIAL BASE K934620 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Sep 1994. https://www.510kdatabase.net/k942939/ 1994-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k942939-cordis-steadfast-magnetic-exchange-fda-510k.jpg K942939 - CORDIS STEADFAST MAGNETIC EXCHANGE SYSTEM K942939 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Aug 1994. https://www.510kdatabase.net/k944027/ 1994-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k944027-ag-839pa-co2-module-and-accessories-fda-510k.jpg K944027 - AG-839PA CO2 MODULE AND ACCESSORIES K944027 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Aug 1994. https://www.510kdatabase.net/k940697/ 1994-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k940697-becton-dickinson-interlinktm-levery-lock-fda-510k.jpg K940697 - BECTON DICKINSON INTERLINK(TM) LEVER/Y LOCK K940697 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1994. https://www.510kdatabase.net/k931763/ 1994-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k931763-hf-resection-electrode-loop-wrunner-fda-510k.jpg K931763 - HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS K931763 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Corp.. Cleared Aug 1994. https://www.510kdatabase.net/k940914/ 1994-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k940914-new-luting-cement-material-nlc-fda-510k.jpg K940914 - NEW LUTING CEMENT MATERIAL (NLC) K940914 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Aug 1994. https://www.510kdatabase.net/k943191/ 1994-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k943191-microvasiver-monolithtm-mechanical-fda-510k.jpg K943191 - MICROVASIVE(R) MONOLITH(TM) MECHANICAL LITHOTRIPTOR K943191 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Aug 1994. https://www.510kdatabase.net/k943496/ 1994-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k943496-monoject-tray-size-sharps-container-fda-510k.jpg K943496 - MONOJECT TRAY SIZE SHARPS CONTAINER K943496 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Aug 1994. https://www.510kdatabase.net/k943582/ 1994-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k943582-softwear-porcelain-system-fda-510k.jpg K943582 - SOFTWEAR PORCELAIN SYSTEM K943582 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Aug 1994. https://www.510kdatabase.net/k943779/ 1994-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k943779-argesol-720-fda-510k.jpg K943779 - ARGESOL #720 K943779 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Aug 1994. https://www.510kdatabase.net/k935270/ 1994-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k935270-modular-forcep-and-scissor-system-fda-510k.jpg K935270 - MODULAR FORCEP AND SCISSOR SYSTEM K935270 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Aug 1994. https://www.510kdatabase.net/k941837/ 1994-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k941837-roche-reagent-for-creatinine-fda-510k.jpg K941837 - ROCHE REAGENT FOR CREATININE K941837 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Aug 1994. https://www.510kdatabase.net/k943149/ 1994-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k943149-access-red-blood-cell-folate-assay-fda-510k.jpg K943149 - ACCESS RED BLOOD CELL FOLATE ASSAY K943149 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Aug 1994. https://www.510kdatabase.net/k933289/ 1994-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k933289-thick-tibial-insert-fda-510k.jpg K933289 - THICK TIBIAL INSERT K933289 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Aug 1994. https://www.510kdatabase.net/k941681/ 1994-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k941681-arthrex-circular-harvesting-saw-fda-510k.jpg K941681 - ARTHREX CIRCULAR HARVESTING SAW K941681 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Aug 1994. https://www.510kdatabase.net/k941996/ 1994-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k941996-edge-fda-510k.jpg K941996 - EDGE K941996 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Aug 1994. https://www.510kdatabase.net/k942564/ 1994-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k942564-argyle-neo-sert-fda-510k.jpg K942564 - ARGYLE NEO-SERT K942564 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Aug 1994. https://www.510kdatabase.net/k942817/ 1994-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k942817-ccd-endocam-office-5510-fda-510k.jpg K942817 - CCD ENDOCAM OFFICE 5510 K942817 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Aug 1994. https://www.510kdatabase.net/k942606/ 1994-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k942606-surgical-staple-fda-510k.jpg K942606 - SURGICAL STAPLE K942606 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Aug 1994. https://www.510kdatabase.net/k940606/ 1994-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k940606-hispeed-advantage-ii-fda-510k.jpg K940606 - HISPEED ADVANTAGE II K940606 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Aug 1994. https://www.510kdatabase.net/k943574/ 1994-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k943574-capture-impression-material-fda-510k.jpg K943574 - CAPTURE IMPRESSION MATERIAL K943574 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Aug 1994. https://www.510kdatabase.net/k943578/ 1994-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k943578-monoject-high-volumechemotherapy-fda-510k.jpg K943578 - MONOJECT HIGH VOLUME/CHEMOTHERAPY SHARPS CONTAINER K943578 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Aug 1994. https://www.510kdatabase.net/k943700/ 1994-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k943700-karl-storz-bronchoscope-accessories-fda-510k.jpg K943700 - KARL STORZ BRONCHOSCOPE ACCESSORIES K943700 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Aug 1994. https://www.510kdatabase.net/k935721/ 1994-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k935721-stone-extractor-fda-510k.jpg K935721 - STONE EXTRACTOR K935721 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Aug 1994. https://www.510kdatabase.net/k942885/ 1994-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k942885-auto-suture-modified-grip-fda-510k.jpg K942885 - AUTO SUTURE MODIFIED GRIP K942885 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Aug 1994. https://www.510kdatabase.net/k943652/ 1994-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k943652-vascular-mp-x-ray-generator-fda-510k.jpg K943652 - VASCULAR MP X-RAY GENERATOR K943652 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Aug 1994. https://www.510kdatabase.net/k910318/ 1994-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k910318-bardr-hydrogelsilver-coated-foley-fda-510k.jpg K910318 - BARD(R) HYDROGEL/SILVER-COATED FOLEY CATHETER K910318 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Aug 1994. https://www.510kdatabase.net/k940838/ 1994-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k940838-microvasive-ultraflex-esophageal-stent-fda-510k.jpg K940838 - MICROVASIVE ULTRAFLEX ESOPHAGEAL STENT SYSTEM K940838 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Aug 1994. https://www.510kdatabase.net/k941614/ 1994-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k941614-axsym-tobramycin-fda-510k.jpg K941614 - AXSYM TOBRAMYCIN K941614 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1994. https://www.510kdatabase.net/k943667/ 1994-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k943667-esophagoscope-and-accessories-fda-510k.jpg K943667 - ESOPHAGOSCOPE AND ACCESSORIES K943667 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Aug 1994. https://www.510kdatabase.net/k935267/ 1994-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k935267-b-d-digital-thermometer-fda-510k.jpg K935267 - B-D DIGITAL THERMOMETER K935267 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1994. https://www.510kdatabase.net/k940224/ 1994-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k940224-cardio-rep-ld-fda-510k.jpg K940224 - CARDIO REP LD K940224 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Aug 1994. https://www.510kdatabase.net/k940386/ 1994-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k940386-kodak-automixer-iii-integrated-kodak-fda-510k.jpg K940386 - KODAK AUTOMIXER III INTEGRATED, KODAK AUTOMIXER III 180 LP K940386 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Aug 1994. https://www.510kdatabase.net/k940550/ 1994-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k940550-cook-brach-needleradio-deliv-cathflexi-fda-510k.jpg K940550 - COOK BRACH NEEDLE/RADIO DELIV CATH/FLEXI FLEXICATH K940550 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cook, Inc.. Cleared Aug 1994. https://www.510kdatabase.net/k943594/ 1994-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k943594-baxter-one-gallon-sharps-disposal-fda-510k.jpg K943594 - BAXTER ONE GALLON SHARPS DISPOSAL CONTAINERS K943594 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Aug 1994. https://www.510kdatabase.net/k943605/ 1994-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k943605-baxter-two-gallon-sharps-disposal-fda-510k.jpg K943605 - BAXTER TWO GALLON SHARPS DISPOSAL CONTAINERS K943605 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Aug 1994. https://www.510kdatabase.net/k943737/ 1994-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k943737-microvasive-pathfinder-exchange-fda-510k.jpg K943737 - MICROVASIVE PATHFINDER EXCHANGE GUIDEWIRE INSURG PATHFINDER GUIDEWIRE K943737 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Aug 1994. https://www.510kdatabase.net/k941225/ 1994-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k941225-univix-gold-membrane-oxygenation-fda-510k.jpg K941225 - UNIVIX GOLD MEMBRANE OXYGENATION MODULE WITH DUROFLO II HEPARIN TREATMENT K941225 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Aug 1994. https://www.510kdatabase.net/k941615/ 1994-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k941615-axsym-valproic-acid-fda-510k.jpg K941615 - AXSYM VALPROIC ACID K941615 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1994. https://www.510kdatabase.net/k942566/ 1994-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k942566-imx-ultrasensistive-htsh-ii-fda-510k.jpg K942566 - IMX ULTRASENSISTIVE HTSH II K942566 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1994. https://www.510kdatabase.net/k934959/ 1994-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k934959-model-118-fetalmaternal-monitor-fda-510k.jpg K934959 - MODEL 118 FETAL/MATERNAL MONITOR K934959 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Aug 1994. https://www.510kdatabase.net/k936269/ 1994-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k936269-caspar-titanium-alloy-bone-screws-fda-510k.jpg K936269 - CASPAR TITANIUM ALLOY BONE SCREWS K936269 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aesculap, Inc.. Cleared Aug 1994. https://www.510kdatabase.net/k941235/ 1994-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k941235-vista-b12-assay-fda-510k.jpg K941235 - VISTA B12 ASSAY K941235 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Aug 1994. https://www.510kdatabase.net/k942612/ 1994-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k942612-karl-storz-wound-closure-instruments-fda-510k.jpg K942612 - KARL STORZ WOUND CLOSURE INSTRUMENTS K942612 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Aug 1994. https://www.510kdatabase.net/k942887/ 1994-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k942887-model-m1310a-series-50t-fetal-fda-510k.jpg K942887 - MODEL M1310A, SERIES 50T FETAL TELEMETRY SYSTEM K942887 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Aug 1994. https://www.510kdatabase.net/k940234/ 1994-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k940234-carpal-tunnel-system-fda-510k.jpg K940234 - CARPAL TUNNEL SYSTEM K940234 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Aug 1994. https://www.510kdatabase.net/k941950/ 1994-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k941950-opsis-thoracoscopy-video-system-fda-510k.jpg K941950 - OPSIS THORACOSCOPY VIDEO SYSTEM THORACICCAM AND THORACICCAM 360 K941950 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Baxter Healthcare Corp. Cleared Aug 1994. https://www.510kdatabase.net/k932208/ 1994-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k932208-extracorporeal-circuit-wduraflo-ii-fda-510k.jpg K932208 - EXTRACORPOREAL CIRCUIT W/DURAFLO II HEPARIN TREATM K932208 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Aug 1994. https://www.510kdatabase.net/k935055/ 1994-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k935055-roche-abuscreen-radioimmunoassay-for-fda-510k.jpg K935055 - ROCHE ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (HIGH CUT-OFF) K935055 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Aug 1994. https://www.510kdatabase.net/k940178/ 1994-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k940178-percor-stat-dl-95-fr34cc-40cc-percor-fda-510k.jpg K940178 - PERCOR STAT-DL 9.5 FR.34CC & 40CC /PERCOR STAT-DL 10.5 FR.40CC & 50CC INTRA-AORTIC BALLOON MODIFICATION K940178 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Aug 1994. https://www.510kdatabase.net/k941684/ 1994-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k941684-ivex-2-extension-set-with-y-injection-fda-510k.jpg K941684 - IVEX-2 EXTENSION SET WITH Y-INJECTION SITE K941684 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1994. https://www.510kdatabase.net/k940905/ 1994-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k940905-microtainer-brand-tube-with-edtak2-fda-510k.jpg K940905 - MICROTAINER BRAND TUBE WITH EDTA(K2) K940905 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1994. https://www.510kdatabase.net/k943074/ 1994-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k943074-forceps-punches-scissors-fda-510k.jpg K943074 - FORCEPS, PUNCHES, SCISSORS K943074 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Aug 1994. https://www.510kdatabase.net/k932721/ 1994-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k932721-arthrotek-set-screw-fda-510k.jpg K932721 - ARTHROTEK SET SCREW K932721 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Aug 1994. https://www.510kdatabase.net/k934059/ 1994-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k934059-dall-miles-system-grooved-button-fda-510k.jpg K934059 - DALL MILES SYSTEM GROOVED BUTTON K934059 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Aug 1994. https://www.510kdatabase.net/k943208/ 1994-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k943208-argesol-750py-fda-510k.jpg K943208 - ARGESOL 750PY K943208 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Aug 1994. https://www.510kdatabase.net/k943209/ 1994-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k943209-argesol-pnp-fda-510k.jpg K943209 - ARGESOL PNP K943209 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Aug 1994. https://www.510kdatabase.net/k943210/ 1994-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k943210-argesol-1005y-fda-510k.jpg K943210 - ARGESOL #1005Y K943210 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Aug 1994. https://www.510kdatabase.net/k943211/ 1994-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k943211-argesol-750y-fda-510k.jpg K943211 - ARGESOL 750Y K943211 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Aug 1994. https://www.510kdatabase.net/k943212/ 1994-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k943212-argesol-830y-fda-510k.jpg K943212 - ARGESOL #830Y K943212 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Aug 1994. https://www.510kdatabase.net/k943213/ 1994-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k943213-argiplus-lo-fda-510k.jpg K943213 - ARGIPLUS LO K943213 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Aug 1994. https://www.510kdatabase.net/k943214/ 1994-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k943214-solder-204-fda-510k.jpg K943214 - SOLDER #204 K943214 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Aug 1994. https://www.510kdatabase.net/k943264/ 1994-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k943264-solder-205-fda-510k.jpg K943264 - SOLDER #205 K943264 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Aug 1994. https://www.510kdatabase.net/k943266/ 1994-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k943266-solder-210-fda-510k.jpg K943266 - SOLDER #210 K943266 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Aug 1994. https://www.510kdatabase.net/k943267/ 1994-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k943267-solder-211-fda-510k.jpg K943267 - SOLDER #211 K943267 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Aug 1994. https://www.510kdatabase.net/k943269/ 1994-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k943269-solder-209-fda-510k.jpg K943269 - SOLDER #209 K943269 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Aug 1994. https://www.510kdatabase.net/k943271/ 1994-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k943271-solder-206-fda-510k.jpg K943271 - SOLDER #206 K943271 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Aug 1994. https://www.510kdatabase.net/k934513/ 1994-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k934513-provider-pump-set-winfusion-cartridge-fda-510k.jpg K934513 - PROVIDER PUMP SET W/INFUSION CARTRIDGE K934513 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Jul 1994. https://www.510kdatabase.net/k935875/ 1994-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k935875-osteonics-screwless-acetabular-fda-510k.jpg K935875 - OSTEONICS SCREWLESS ACETABULAR COMPONENTS K935875 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Jul 1994. https://www.510kdatabase.net/k941745/ 1994-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k941745-tsx-002a-xvision-ct-scanner-fda-510k.jpg K941745 - TSX-002A (XVISION) CT SCANNER K941745 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Jul 1994. https://www.510kdatabase.net/k942909/ 1994-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k942909-kodak-insight-twin-load-insert-fda-510k.jpg K942909 - KODAK INSIGHT TWIN-LOAD INSERT K942909 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Jul 1994. https://www.510kdatabase.net/k933367/ 1994-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k933367-gore-tex-facial-implant-fda-510k.jpg K933367 - GORE-TEX FACIAL IMPLANT K933367 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Jul 1994. https://www.510kdatabase.net/k941408/ 1994-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k941408-merit-fda-510k.jpg K941408 - MERIT K941408 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Jul 1994. https://www.510kdatabase.net/k942280/ 1994-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k942280-goretex-sam-facial-implant-fda-510k.jpg K942280 - GORETEX SAM FACIAL IMPLANT K942280 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Jul 1994. https://www.510kdatabase.net/k941233/ 1994-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k941233-global-shoulder-or-drape-pack-fda-510k.jpg K941233 - GLOBAL SHOULDER O.R. DRAPE PACK K941233 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Depuy, Inc.. Cleared Jul 1994. https://www.510kdatabase.net/k942839/ 1994-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k942839-olympus-superview-laparoscope-for-fda-510k.jpg K942839 - OLYMPUS SUPERVIEW LAPAROSCOPE FOR GENERAL SURGERY K942839 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Olympus America, Inc.. Cleared Jul 1994. https://www.510kdatabase.net/k943116/ 1994-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k943116-auto-suture-kerrison-spinal-rongeur-fda-510k.jpg K943116 - AUTO SUTURE KERRISON SPINAL RONGEUR K943116 is a FDA 510(k) cleared neurology medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Jul 1994. https://www.510kdatabase.net/k935772/ 1994-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k935772-hp-m177xa-cardiographs-fda-510k.jpg K935772 - HP M177XA CARDIOGRAPHS K935772 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Jul 1994. https://www.510kdatabase.net/k930867/ 1994-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k930867-auto-suture-disposable-uterine-fda-510k.jpg K930867 - AUTO SUTURE DISPOSABLE UTERINE MANIPULATOR K930867 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Jul 1994. https://www.510kdatabase.net/k943115/ 1994-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k943115-auto-suture-pituitary-spinal-rongeur-fda-510k.jpg K943115 - AUTO SUTURE PITUITARY SPINAL RONGEUR K943115 is a FDA 510(k) cleared neurology medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Jul 1994. https://www.510kdatabase.net/k942929/ 1994-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k942929-argesol-lo-fda-510k.jpg K942929 - ARGESOL LO K942929 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jul 1994. https://www.510kdatabase.net/k942943/ 1994-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k942943-argesol-novasol-fda-510k.jpg K942943 - ARGESOL-NOVASOL K942943 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jul 1994. https://www.510kdatabase.net/k942978/ 1994-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k942978-argesol-650-fda-510k.jpg K942978 - ARGESOL #650 K942978 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jul 1994. https://www.510kdatabase.net/k942979/ 1994-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k942979-argesol-argicraft-1-fda-510k.jpg K942979 - ARGESOL-ARGICRAFT-1 K942979 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jul 1994. https://www.510kdatabase.net/k942980/ 1994-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k942980-argesol-615-fda-510k.jpg K942980 - ARGESOL #615 K942980 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jul 1994. https://www.510kdatabase.net/k942981/ 1994-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k942981-argesol-585-fda-510k.jpg K942981 - ARGESOL #585 K942981 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jul 1994. https://www.510kdatabase.net/k943032/ 1994-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k943032-aurium-y-fda-510k.jpg K943032 - AURIUM Y+ K943032 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jul 1994. https://www.510kdatabase.net/k943037/ 1994-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k943037-argedent-41-fda-510k.jpg K943037 - ARGEDENT 41 K943037 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jul 1994. https://www.510kdatabase.net/k943087/ 1994-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k943087-argesol-750w-fda-510k.jpg K943087 - ARGESOL 750W K943087 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jul 1994. https://www.510kdatabase.net/k943088/ 1994-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k943088-argesol-r-fda-510k.jpg K943088 - ARGESOL R K943088 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jul 1994. https://www.510kdatabase.net/k943089/ 1994-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k943089-argesol-830w-fda-510k.jpg K943089 - ARGESOL 830W K943089 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jul 1994. https://www.510kdatabase.net/k935243/ 1994-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k935243-aesculap-flexible-trocar-instrument-set-fda-510k.jpg K935243 - AESCULAP FLEXIBLE TROCAR INSTRUMENT SET K935243 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Jul 1994. https://www.510kdatabase.net/k940948/ 1994-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k940948-angled-dissectors-models-8383581582571-fda-510k.jpg K940948 - ANGLED DISSECTORS MODELS 8383.581/582/571 K940948 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Jul 1994. https://www.510kdatabase.net/k942615/ 1994-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k942615-syringe-fda-510k.jpg K942615 - SYRINGE K942615 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jul 1994. https://www.510kdatabase.net/k942677/ 1994-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k942677-geenenzebra-guidelines-fda-510k.jpg K942677 - GEENEN/ZEBRA GUIDELINES K942677 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Jul 1994. https://www.510kdatabase.net/k942859/ 1994-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k942859-argesol-ypf-fda-510k.jpg K942859 - ARGESOL-YPF K942859 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jul 1994. https://www.510kdatabase.net/k942928/ 1994-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k942928-argesol-500-fda-510k.jpg K942928 - ARGESOL 500 K942928 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jul 1994. https://www.510kdatabase.net/k932429/ 1994-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k932429-cordis-gravity-compensating-accessory-fda-510k.jpg K932429 - CORDIS GRAVITY COMPENSATING ACCESSORY K932429 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cordis Corp.. Cleared Jul 1994. https://www.510kdatabase.net/k935984/ 1994-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k935984-glutamyl-transferase-procedure-no-419-fda-510k.jpg K935984 - GLUTAMYL-TRANSFERASE, PROCEDURE NO. 419 K935984 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Jul 1994. https://www.510kdatabase.net/k941981/ 1994-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k941981-axillobifemoral-gore-tex-cascular-fda-510k.jpg K941981 - AXILLOBIFEMORAL GORE-TEX CASCULAR GRAFT,BIFURCATED K941981 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Jul 1994. https://www.510kdatabase.net/k942967/ 1994-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k942967-auto-suture-spinal-curette-fda-510k.jpg K942967 - AUTO SUTURE SPINAL CURETTE K942967 is a FDA 510(k) cleared neurology medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Jul 1994. https://www.510kdatabase.net/k942968/ 1994-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k942968-auto-suture-spinal-osteotome-fda-510k.jpg K942968 - AUTO SUTURE SPINAL OSTEOTOME K942968 is a FDA 510(k) cleared neurology medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Jul 1994. https://www.510kdatabase.net/k942969/ 1994-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k942969-auto-suture-spinal-nerve-hook-fda-510k.jpg K942969 - AUTO SUTURE SPINAL NERVE HOOK K942969 is a FDA 510(k) cleared neurology medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Jul 1994. https://www.510kdatabase.net/k942970/ 1994-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k942970-auto-suture-spinal-elevator-fda-510k.jpg K942970 - AUTO SUTURE SPINAL ELEVATOR K942970 is a FDA 510(k) cleared neurology medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Jul 1994. https://www.510kdatabase.net/k942971/ 1994-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k942971-auto-suture-spinal-dissector-fda-510k.jpg K942971 - AUTO SUTURE SPINAL DISSECTOR K942971 is a FDA 510(k) cleared neurology medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Jul 1994. https://www.510kdatabase.net/k940840/ 1994-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k940840-act-control-set-fda-510k.jpg K940840 - ACT CONTROL SET K940840 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Jul 1994. https://www.510kdatabase.net/k940971/ 1994-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k940971-ames-dca-2000-hemoglobin-alc-controls-fda-510k.jpg K940971 - AMES DCA 2000 HEMOGLOBIN ALC CONTROLS K940971 is a FDA 510(k) cleared hematology medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Jul 1994. https://www.510kdatabase.net/k940416/ 1994-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k940416-neurological-leads-packaging-fda-510k.jpg K940416 - NEUROLOGICAL LEADS (PACKAGING MODIFICATION) K940416 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Jul 1994. https://www.510kdatabase.net/k942120/ 1994-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k942120-advantage-windows-diagnostic-x-ray-fda-510k.jpg K942120 - ADVANTAGE WINDOWS DIAGNOSTIC X-RAY WORKSTATION K942120 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Jul 1994. https://www.510kdatabase.net/k922702/ 1994-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k922702-provider-anne-infuser-fda-510k.jpg K922702 - PROVIDER ANNE INFUSER K922702 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Jul 1994. https://www.510kdatabase.net/k940569/ 1994-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k940569-digoxin-fpia-reagent-set-and-fda-510k.jpg K940569 - DIGOXIN FPIA REAGENT SET AND CALIBRATOR SET K940569 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Jul 1994. https://www.510kdatabase.net/k942192/ 1994-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k942192-theophylline-fpia-reagent-set-and-fda-510k.jpg K942192 - THEOPHYLLINE FPIA REAGENT SET AND CALIBRATORS K942192 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Jul 1994. https://www.510kdatabase.net/k933881/ 1994-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k933881-depuy-motech-moss-miami-spinal-system-fda-510k.jpg K933881 - DEPUY MOTECH MOSS-MIAMI SPINAL SYSTEM K933881 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jul 1994. https://www.510kdatabase.net/k940207/ 1994-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k940207-titanium-alloy-bone-screws-fda-510k.jpg K940207 - TITANIUM ALLOY BONE SCREWS K940207 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aesculap, Inc.. Cleared Jul 1994. https://www.510kdatabase.net/k940868/ 1994-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k940868-cordis-opta-5tm-pta-balloon-catheter-fda-510k.jpg K940868 - CORDIS OPTA 5(TM) PTA BALLOON CATHETER, MODIFICATION K940868 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Jul 1994. https://www.510kdatabase.net/k941847/ 1994-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k941847-58-porocoat-aml-hip-porocoat-porous-fda-510k.jpg K941847 - 5/8 POROCOAT AML HIP POROCOAT POROUS COATING K941847 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jul 1994. https://www.510kdatabase.net/k941942/ 1994-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k941942-solution-hip-fda-510k.jpg K941942 - SOLUTION HIP K941942 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jul 1994. https://www.510kdatabase.net/k936099/ 1994-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k936099-neurological-lead-accessories-fda-510k.jpg K936099 - NEUROLOGICAL LEAD ACCESSORIES K936099 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Jul 1994. https://www.510kdatabase.net/k941239/ 1994-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k941239-aesculap-neuroendoscope-fda-510k.jpg K941239 - AESCULAP NEUROENDOSCOPE K941239 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Jul 1994. https://www.510kdatabase.net/k935659/ 1994-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k935659-baxter-night-exch-devicenxd-peritoneal-fda-510k.jpg K935659 - BAXTER NIGHT EXCH DEVICE(NXD) PERITONEAL DIALY SYST K935659 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jul 1994. https://www.510kdatabase.net/k942205/ 1994-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k942205-zebra-urological-guidewire-fda-510k.jpg K942205 - ZEBRA UROLOGICAL GUIDEWIRE K942205 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Jul 1994. https://www.510kdatabase.net/k934457/ 1994-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k934457-stability-hip-stem-with-porocoat-fda-510k.jpg K934457 - STABILITY HIP STEM WITH POROCOAT K934457 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jul 1994. https://www.510kdatabase.net/k941355/ 1994-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k941355-pregnancy-check-fda-510k.jpg K941355 - PREGNANCY CHECK K941355 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sa Scientific, Inc.. Cleared Jul 1994. https://www.510kdatabase.net/k941440/ 1994-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k941440-cobas-fp-quinidine-reagents-and-fda-510k.jpg K941440 - COBAS-FP QUINIDINE REAGENTS AND CALIBRATORS K941440 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jul 1994. https://www.510kdatabase.net/k941770/ 1994-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k941770-duraprene-sterile-synthetic-surgeons-fda-510k.jpg K941770 - DURAPRENE STERILE SYNTHETIC SURGEON'S GLOVES K941770 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jul 1994. https://www.510kdatabase.net/k942493/ 1994-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k942493-scotchbond-multi-purpose-plus-dental-fda-510k.jpg K942493 - SCOTCHBOND MULTI-PURPOSE PLUS DENTAL ADHESIVE SYSTEM K942493 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Jul 1994. https://www.510kdatabase.net/k941509/ 1994-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k941509-radias-ana-screen-enzyme-immunoassay-fda-510k.jpg K941509 - RADIAS ANA SCREEN ENZYME IMMUNOASSAY K941509 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Jun 1994. https://www.510kdatabase.net/k940222/ 1994-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k940222-smith-and-nephew-spine-deflecting-fda-510k.jpg K940222 - SMITH AND NEPHEW SPINE DEFLECTING FORCEPS K940222 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jun 1994. https://www.510kdatabase.net/k933202/ 1994-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k933202-venus-diagnostic-ultrasound-system-fda-510k.jpg K933202 - VENUS DIAGNOSTIC ULTRASOUND SYSTEM K933202 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Jun 1994. https://www.510kdatabase.net/k941779/ 1994-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k941779-karl-storz-11274-series-flexible-fda-510k.jpg K941779 - KARL STORZ 11274 SERIES FLEXIBLE FIBERSCOPE K941779 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jun 1994. https://www.510kdatabase.net/k935278/ 1994-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k935278-karl-storz-fixed-magnification-fda-510k.jpg K935278 - KARL STORZ FIXED MAGNIFICATION TELESCOPE/KARL STORZ VARIABLE MAGNIFICATION TELESCOPE K935278 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jun 1994. https://www.510kdatabase.net/k940464/ 1994-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k940464-karl-storz-uretero-renoscopeureterscope-fda-510k.jpg K940464 - KARL STORZ URETERO-RENOSCOPE/URETERSCOPE K940464 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jun 1994. https://www.510kdatabase.net/k942589/ 1994-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k942589-argesol-p-fda-510k.jpg K942589 - ARGESOL P K942589 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jun 1994. https://www.510kdatabase.net/k942590/ 1994-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k942590-argesol-w-fda-510k.jpg K942590 - ARGESOL W K942590 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jun 1994. https://www.510kdatabase.net/k942595/ 1994-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k942595-argelite-pf-fda-510k.jpg K942595 - ARGELITE PF+ K942595 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jun 1994. https://www.510kdatabase.net/k934312/ 1994-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k934312-axsymtm-t-uptake-fda-510k.jpg K934312 - AXSYM(TM) T-UPTAKE K934312 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1994. https://www.510kdatabase.net/k934384/ 1994-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k934384-axsymtm-total-t4-fda-510k.jpg K934384 - AXSYM(TM) TOTAL T4 K934384 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1994. https://www.510kdatabase.net/k934410/ 1994-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k934410-axsym-ultrasensitive-htsh-fda-510k.jpg K934410 - AXSYM ULTRASENSITIVE HTSH K934410 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1994. https://www.510kdatabase.net/k934517/ 1994-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k934517-axsym-total-t3-fda-510k.jpg K934517 - AXSYM TOTAL T3 K934517 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1994. https://www.510kdatabase.net/k934544/ 1994-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k934544-axsym-free-thyroxine-free-t4-fda-510k.jpg K934544 - AXSYM FREE THYROXINE ( FREE T4 ) K934544 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1994. https://www.510kdatabase.net/k934835/ 1994-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k934835-floval-fda-510k.jpg K934835 - FLOVAL K934835 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Corp.. Cleared Jun 1994. https://www.510kdatabase.net/k935373/ 1994-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k935373-axsym-theophylline-fda-510k.jpg K935373 - AXSYM THEOPHYLLINE K935373 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1994. https://www.510kdatabase.net/k935374/ 1994-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k935374-axsym-carbamazephine-fda-510k.jpg K935374 - AXSYM CARBAMAZEPHINE K935374 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1994. https://www.510kdatabase.net/k935375/ 1994-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k935375-axsym-phenytoin-assay-fda-510k.jpg K935375 - AXSYM PHENYTOIN ASSAY K935375 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1994. https://www.510kdatabase.net/k935611/ 1994-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k935611-axsym-luteinizing-hormone-lh-fda-510k.jpg K935611 - AXSYM LUTEINIZING HORMONE (LH) K935611 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1994. https://www.510kdatabase.net/k935612/ 1994-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k935612-axsym-follicle-stimulating-hormone-fsh-fda-510k.jpg K935612 - AXSYM FOLLICLE STIMULATING HORMONE (FSH) K935612 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1994. https://www.510kdatabase.net/k935673/ 1994-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k935673-axsym-total-b-hcg-fda-510k.jpg K935673 - AXSYM TOTAL B-HCG K935673 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1994. https://www.510kdatabase.net/k935675/ 1994-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k935675-axsym-prolactin-fda-510k.jpg K935675 - AXSYM PROLACTIN K935675 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1994. https://www.510kdatabase.net/k935847/ 1994-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k935847-axsym-ferritin-fda-510k.jpg K935847 - AXSYM FERRITIN K935847 is a FDA 510(k) cleared immunology medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1994. https://www.510kdatabase.net/k935924/ 1994-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k935924-axsym-ck-mb-fda-510k.jpg K935924 - AXSYM CK-MB K935924 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1994. https://www.510kdatabase.net/k940595/ 1994-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k940595-axsym-vancomycin-fda-510k.jpg K940595 - AXSYM VANCOMYCIN K940595 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1994. https://www.510kdatabase.net/k940596/ 1994-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k940596-axsym-phenobarbital-fda-510k.jpg K940596 - AXSYM PHENOBARBITAL K940596 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1994. https://www.510kdatabase.net/k940682/ 1994-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k940682-axsymtm-quinidine-fda-510k.jpg K940682 - AXSYM(TM) QUINIDINE K940682 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1994. https://www.510kdatabase.net/k936036/ 1994-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k936036-karl-storz-instruments-for-bipolar-fda-510k.jpg K936036 - KARL STORZ INSTRUMENTS FOR BIPOLAR COAGULATION K936036 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jun 1994. https://www.510kdatabase.net/k942329/ 1994-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k942329-hand-controlled-syringe-fda-510k.jpg K942329 - HAND CONTROLLED SYRINGE K942329 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1994. https://www.510kdatabase.net/k935997/ 1994-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k935997-platinum-plus-guidewire-fda-510k.jpg K935997 - PLATINUM PLUS GUIDEWIRE K935997 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Jun 1994. https://www.510kdatabase.net/k941095/ 1994-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k941095-medsaver-syringe-fda-510k.jpg K941095 - MEDSAVER SYRINGE K941095 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jun 1994. https://www.510kdatabase.net/k941912/ 1994-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k941912-nt-protein-control-syl-m-and-h-fda-510k.jpg K941912 - N/T PROTEIN CONTROL SY/L, M, AND H K941912 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Jun 1994. https://www.510kdatabase.net/k942209/ 1994-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k942209-liquichek-hematology-16-control-low-fda-510k.jpg K942209 - LIQUICHEK HEMATOLOGY-16 CONTROL, LOW, NORMAL AND HIGH K942209 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bio-Rad. Cleared Jun 1994. https://www.510kdatabase.net/k942462/ 1994-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k942462-argesol-ysf-pre-solder-for-hi-gold-fda-510k.jpg K942462 - ARGESOL-YSF PRE-SOLDER FOR HI GOLD DENT PORCEL ALLOYS K942462 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jun 1994. https://www.510kdatabase.net/k942505/ 1994-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k942505-argesol-wsf-pre-solder-for-high-gold-fda-510k.jpg K942505 - ARGESOL-WSF PRE-SOLDER FOR HIGH GOLD DENTAL PROCELAIN ALLOYS K942505 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jun 1994. https://www.510kdatabase.net/k942507/ 1994-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k942507-argesol-y-fda-510k.jpg K942507 - ARGESOL-Y K942507 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jun 1994. https://www.510kdatabase.net/k942538/ 1994-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k942538-argesol-1040y-fda-510k.jpg K942538 - ARGESOL-1040Y K942538 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jun 1994. https://www.510kdatabase.net/k942539/ 1994-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k942539-argesol-lite-fda-510k.jpg K942539 - ARGESOL-LITE K942539 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jun 1994. https://www.510kdatabase.net/k942540/ 1994-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k942540-argesol-wg-fda-510k.jpg K942540 - ARGESOL-WG K942540 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jun 1994. https://www.510kdatabase.net/k942557/ 1994-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k942557-argesol-1060w-fda-510k.jpg K942557 - ARGESOL-1060W K942557 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jun 1994. https://www.510kdatabase.net/k931617/ 1994-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k931617-exactech-ziramic-femoral-head-component-fda-510k.jpg K931617 - EXACTECH ZIRAMIC FEMORAL HEAD COMPONENT K931617 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Jun 1994. https://www.510kdatabase.net/k934938/ 1994-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k934938-temporary-screening-leadcatheter-kit-fda-510k.jpg K934938 - TEMPORARY SCREENING LEAD/CATHETER KIT K934938 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Jun 1994. https://www.510kdatabase.net/k940577/ 1994-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k940577-glucometer-elite-low-control-fda-510k.jpg K940577 - GLUCOMETER ELITE LOW CONTROL K940577 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Jun 1994. https://www.510kdatabase.net/k941142/ 1994-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k941142-kodak-ektachem-clinical-chemistry-fda-510k.jpg K941142 - KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE PHENYTOIN K941142 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Jun 1994. https://www.510kdatabase.net/k941254/ 1994-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k941254-dye-management-system-fda-510k.jpg K941254 - DYE MANAGEMENT SYSTEM K941254 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1994. https://www.510kdatabase.net/k941712/ 1994-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k941712-cobas-fp-reagents-and-calibrators-fda-510k.jpg K941712 - COBAS-FP REAGENTS AND CALIBRATORS K941712 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jun 1994. https://www.510kdatabase.net/k922627/ 1994-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k922627-gore-tex-regenerative-material-fda-510k.jpg K922627 - GORE-TEX REGENERATIVE MATERIAL K922627 is a FDA 510(k) cleared dental medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Jun 1994. https://www.510kdatabase.net/k932477/ 1994-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k932477-unimix-conainer-empty-container-w3-fda-510k.jpg K932477 - UNIMIX CONAINER-EMPTY CONTAINER W/3 LEAD TRANS.SET K932477 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jun 1994. https://www.510kdatabase.net/k941572/ 1994-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k941572-fluoride-psa-primeadhesive-fda-510k.jpg K941572 - FLUORIDE-PSA PRIME/ADHESIVE K941572 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jun 1994. https://www.510kdatabase.net/k942031/ 1994-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k942031-caulk-tooth-conditioner-gel-and-syringe-fda-510k.jpg K942031 - CAULK TOOTH CONDITIONER GEL AND SYRINGE K942031 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jun 1994. https://www.510kdatabase.net/k942044/ 1994-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k942044-bard-endoscopic-overtube-fda-510k.jpg K942044 - BARD ENDOSCOPIC OVERTUBE K942044 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jun 1994. https://www.510kdatabase.net/k942053/ 1994-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k942053-aesculap-interchangeable-trocar-fda-510k.jpg K942053 - AESCULAP INTERCHANGEABLE TROCAR INSTRUMENT SET K942053 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Jun 1994. https://www.510kdatabase.net/k925102/ 1994-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k925102-flexiflo-laparoscopic-jejunostomy-kit-fda-510k.jpg K925102 - FLEXIFLO LAPAROSCOPIC JEJUNOSTOMY KIT K925102 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1994. https://www.510kdatabase.net/k932861/ 1994-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k932861-flexiflo-gastrostomy-kit-fda-510k.jpg K932861 - FLEXIFLO GASTROSTOMY KIT K932861 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1994. https://www.510kdatabase.net/k934119/ 1994-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k934119-energized-drug-container-system-fda-510k.jpg K934119 - ENERGIZED DRUG CONTAINER SYSTEM K934119 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1994. https://www.510kdatabase.net/k931764/ 1994-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k931764-hf-resection-electrode-loop-wrunner-fda-510k.jpg K931764 - HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES K931764 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Olympus Corp.. Cleared Jun 1994. https://www.510kdatabase.net/k942063/ 1994-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k942063-disposable-nasal-scissor-fda-510k.jpg K942063 - DISPOSABLE NASAL SCISSOR K942063 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Jun 1994. https://www.510kdatabase.net/k942064/ 1994-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k942064-disposable-nasal-rongeur-fda-510k.jpg K942064 - DISPOSABLE NASAL RONGEUR K942064 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Jun 1994. https://www.510kdatabase.net/k933281/ 1994-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k933281-sos-proximal-femur-fda-510k.jpg K933281 - S.O.S. PROXIMAL FEMUR K933281 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Jun 1994. https://www.510kdatabase.net/k933330/ 1994-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k933330-aesculap-manual-endoscopic-instruments-fda-510k.jpg K933330 - AESCULAP MANUAL ENDOSCOPIC INSTRUMENTS K933330 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Jun 1994. https://www.510kdatabase.net/k941136/ 1994-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k941136-knot-slide-838355-and-8383551-fda-510k.jpg K941136 - KNOT SLIDE 8383.55 AND 8383.551 K941136 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Jun 1994. https://www.510kdatabase.net/k941177/ 1994-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k941177-angiorex-cas-05a-fda-510k.jpg K941177 - ANGIOREX CAS-05A K941177 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Jun 1994. https://www.510kdatabase.net/k942065/ 1994-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k942065-disposable-ent-punch-fda-510k.jpg K942065 - DISPOSABLE ENT PUNCH K942065 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Jun 1994. https://www.510kdatabase.net/k934860/ 1994-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k934860-ti-frame-fda-510k.jpg K934860 - TI-FRAME K934860 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jun 1994. https://www.510kdatabase.net/k940090/ 1994-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k940090-arthroscope-fda-510k.jpg K940090 - ARTHROSCOPE K940090 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Jun 1994. https://www.510kdatabase.net/k942238/ 1994-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k942238-iv-startpak-vascular-access-start-kit-fda-510k.jpg K942238 - I.V. STARTPAK VASCULAR ACCESS START KIT K942238 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jun 1994. https://www.510kdatabase.net/k932603/ 1994-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k932603-apolipoprotien-b-apo-b-fda-510k.jpg K932603 - APOLIPOPROTIEN B (APO B) K932603 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Jun 1994. https://www.510kdatabase.net/k932606/ 1994-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k932606-apolipoprotien-a-1-apo-a-1-fda-510k.jpg K932606 - APOLIPOPROTIEN A-1 (APO A-1) K932606 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Jun 1994. https://www.510kdatabase.net/k940347/ 1994-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k940347-trocars-cannulae-and-sheaths-for-fda-510k.jpg K940347 - TROCARS, CANNULAE AND SHEATHS FOR ENDOSCOPIC AND LAPAROSCOPIC PROCEDURES K940347 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jun 1994. https://www.510kdatabase.net/k940816/ 1994-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k940816-bardr-expanded-ptfe-vascular-graft-fda-510k.jpg K940816 - BARD(R) EXPANDED PTFE VASCULAR GRAFT K940816 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jun 1994. https://www.510kdatabase.net/k936260/ 1994-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k936260-transit-infusion-catheter-fda-510k.jpg K936260 - TRANSIT INFUSION CATHETER K936260 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared May 1994. https://www.510kdatabase.net/k935434/ 1994-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k935434-obstetric-gynecologic-specialized-fda-510k.jpg K935434 - OBSTETRIC-GYNECOLOGIC SPECIALIZED MANUAL INSTRUMENT K935434 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared May 1994. https://www.510kdatabase.net/k941562/ 1994-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k941562-1ml-luer-lok-syringe-fda-510k.jpg K941562 - 1ML LUER-LOK SYRINGE K941562 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared May 1994. https://www.510kdatabase.net/k941657/ 1994-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k941657-bd-micro-fine-ultra-fine-and-allergy-fda-510k.jpg K941657 - BD MICRO FINE, ULTRA FINE, AND ALLERGY SYRINGE K941657 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared May 1994. https://www.510kdatabase.net/k942201/ 1994-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k942201-laparoscopy-dilation-system-fda-510k.jpg K942201 - LAPAROSCOPY DILATION SYSTEM K942201 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared May 1994. https://www.510kdatabase.net/k942202/ 1994-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k942202-suction-and-irrigation-tubes-fda-510k.jpg K942202 - SUCTION AND IRRIGATION TUBES K942202 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared May 1994. https://www.510kdatabase.net/k940707/ 1994-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k940707-3m-surgical-mask-with-face-sheild-fda-510k.jpg K940707 - 3M SURGICAL MASK WITH FACE SHEILD K940707 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared May 1994. https://www.510kdatabase.net/k941392/ 1994-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k941392-jet-unit-cj-handpiece-fda-510k.jpg K941392 - JET UNIT (CJ HANDPIECE) K941392 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared May 1994. https://www.510kdatabase.net/k941545/ 1994-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k941545-advantage-syringe-fda-510k.jpg K941545 - ADVANTAGE SYRINGE K941545 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared May 1994. https://www.510kdatabase.net/k936021/ 1994-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k936021-bacticard-strep-fda-510k.jpg K936021 - BACTICARD STREP K936021 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared May 1994. https://www.510kdatabase.net/k940965/ 1994-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k940965-eliminator-balloon-dilator-fda-510k.jpg K940965 - ELIMINATOR BALLOON DILATOR K940965 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 1994. https://www.510kdatabase.net/k941286/ 1994-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k941286-suture-manipulator-fda-510k.jpg K941286 - SUTURE MANIPULATOR K941286 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared May 1994. https://www.510kdatabase.net/k941946/ 1994-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k941946-lca-angiographic-imaging-system-fda-510k.jpg K941946 - LCA ANGIOGRAPHIC IMAGING SYSTEM K941946 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared May 1994. https://www.510kdatabase.net/k930745/ 1994-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k930745-burron-expediter-braided-balloon-pta-fda-510k.jpg K930745 - BURRON EXPEDITER BRAIDED BALLOON PTA CATHETER K930745 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: B.Braun Medical, Inc.. Cleared May 1994. https://www.510kdatabase.net/k940709/ 1994-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k940709-scissors-grasping-forceps-needle-fda-510k.jpg K940709 - SCISSORS, GRASPING FORCEPS, NEEDLE HOLDERS, DISSECTORS K940709 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Baxter Healthcare Corp. Cleared May 1994. https://www.510kdatabase.net/k941049/ 1994-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k941049-musclemax-electrical-muscle-stimulator-fda-510k.jpg K941049 - MUSCLEMAX ELECTRICAL MUSCLE STIMULATOR K941049 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Smith & Nephew, Inc.. Cleared May 1994. https://www.510kdatabase.net/k941269/ 1994-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k941269-gore-smoother-ii-and-gore-bptb-fda-510k.jpg K941269 - GORE SMOOTHER II AND GORE BPTB K941269 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared May 1994. https://www.510kdatabase.net/k934531/ 1994-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k934531-auto-suture-disposable-light-cable-fda-510k.jpg K934531 - AUTO SUTURE DISPOSABLE LIGHT CABLE K934531 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared May 1994. https://www.510kdatabase.net/k940906/ 1994-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k940906-gore-tex-cardiovascular-patch-fda-510k.jpg K940906 - GORE-TEX CARDIOVASCULAR PATCH K940906 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared May 1994. https://www.510kdatabase.net/k923524/ 1994-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k923524-volumetric-rendering-technique-option-fda-510k.jpg K923524 - VOLUMETRIC RENDERING TECHNIQUE OPTION K923524 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 1994. https://www.510kdatabase.net/k933987/ 1994-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k933987-aor-tex-vascular-graft-fda-510k.jpg K933987 - AOR-TEX VASCULAR GRAFT K933987 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared May 1994. https://www.510kdatabase.net/k935308/ 1994-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k935308-accucolortm-antithrombin-iii-fda-510k.jpg K935308 - ACCUCOLOR(TM) ANTITHROMBIN III CHROMOGENIC ASSAY K935308 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared May 1994. https://www.510kdatabase.net/k941085/ 1994-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k941085-lipase-ps-assay-procedure-no-805-fda-510k.jpg K941085 - LIPASE-PS ASSAY PROCEDURE NO. 805 K941085 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared May 1994. https://www.510kdatabase.net/k941811/ 1994-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k941811-hp-m1175a-m1176a-component-monitoring-fda-510k.jpg K941811 - HP M1175A, M1176A, COMPONENT MONITORING SYSTEM K941811 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared May 1994. https://www.510kdatabase.net/k933102/ 1994-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k933102-howmedica-acetabular-shell-wscrew-holes-fda-510k.jpg K933102 - HOWMEDICA ACETABULAR SHELL W/SCREW HOLES K933102 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared May 1994. https://www.510kdatabase.net/k934697/ 1994-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k934697-microvasive-maxforce-fda-510k.jpg K934697 - MICROVASIVE MAXFORCE K934697 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared May 1994. https://www.510kdatabase.net/k940218/ 1994-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k940218-suresoft-surgical-gloves-fda-510k.jpg K940218 - SURESOFT SURGICAL GLOVES K940218 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared May 1994. https://www.510kdatabase.net/k942061/ 1994-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k942061-disposable-suction-probe-fda-510k.jpg K942061 - DISPOSABLE SUCTION PROBE K942061 is a FDA 510(k) cleared general hospital medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared May 1994. https://www.510kdatabase.net/k933747/ 1994-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k933747-capasee-fda-510k.jpg K933747 - CAPASEE K933747 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared May 1994. https://www.510kdatabase.net/k941611/ 1994-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k941611-tda-4000a4-fda-510k.jpg K941611 - TDA-4000/A4 K941611 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared May 1994. https://www.510kdatabase.net/k935986/ 1994-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k935986-gore-laparoscopic-suture-passer-fda-510k.jpg K935986 - GORE LAPAROSCOPIC SUTURE PASSER K935986 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared May 1994. https://www.510kdatabase.net/k940346/ 1994-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k940346-scissors-for-endoscopic-and-fda-510k.jpg K940346 - SCISSORS FOR ENDOSCOPIC AND LAPAROSCOPIC PROCEDURES K940346 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared May 1994. https://www.510kdatabase.net/k935785/ 1994-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k935785-karl-storz-irrigation-and-suction-fda-510k.jpg K935785 - KARL STORZ IRRIGATION AND SUCTION SYSTEM HANDPIECE AND ACCESSORIES K935785 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared May 1994. https://www.510kdatabase.net/k934043/ 1994-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k934043-karl-storz-electronic-laparoflator-fda-510k.jpg K934043 - KARL STORZ ELECTRONIC LAPAROFLATOR K934043 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared May 1994. https://www.510kdatabase.net/k934114/ 1994-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k934114-karl-storz-electronic-laparoflator-fda-510k.jpg K934114 - KARL STORZ ELECTRONIC LAPAROFLATOR K934114 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared May 1994. https://www.510kdatabase.net/k936212/ 1994-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k936212-glucofilm-test-strips-fda-510k.jpg K936212 - GLUCOFILM TEST STRIPS K936212 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared May 1994. https://www.510kdatabase.net/k940462/ 1994-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k940462-hydromat-trumpet-valve-and-tubing-set-fda-510k.jpg K940462 - HYDROMAT TRUMPET VALVE AND TUBING SET FOR LAPAROSCOPIC SUCTION AND IRRIGATION K940462 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared May 1994. https://www.510kdatabase.net/k940049/ 1994-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k940049-knot-pusher-spoon-forceps-and-biopsy-fda-510k.jpg K940049 - KNOT PUSHER, SPOON FORCEPS AND BIOPSY FORCEPS K940049 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Baxter Healthcare Corp. Cleared May 1994. https://www.510kdatabase.net/k940581/ 1994-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k940581-bageasyr-iii-childinfant-dispos-man-fda-510k.jpg K940581 - BAGEASY(R) III CHILD/INFANT DISPOS MAN RESUSCITATORS K940581 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared May 1994. https://www.510kdatabase.net/k931194/ 1994-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k931194-co-cr-answer-femoral-component-fda-510k.jpg K931194 - CO-CR ANSWER FEMORAL COMPONENT K931194 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared May 1994. https://www.510kdatabase.net/k940867/ 1994-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k940867-control-a-flotm-regulator-fda-510k.jpg K940867 - CONTROL-A-FLO(TM) REGULATOR K940867 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared May 1994. https://www.510kdatabase.net/k932202/ 1994-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k932202-model-3862a-b-3863a-b-temp-lead-fda-510k.jpg K932202 - MODEL 3862A & B 3863A & B TEMP. LEAD SCREENING KIT K932202 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared May 1994. https://www.510kdatabase.net/k940624/ 1994-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k940624-3m-tegasorb-hydrocolloid-dressing-fda-510k.jpg K940624 - 3M TEGASORB HYDROCOLLOID DRESSING K940624 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3M Company. Cleared May 1994. https://www.510kdatabase.net/k940824/ 1994-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k940824-diastattm-vascular-access-graftclass-iii-fda-510k.jpg K940824 - DIASTAT(TM) VASCULAR ACCESS GRAFT/CLASS III K940824 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared May 1994. https://www.510kdatabase.net/k940236/ 1994-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k940236-quantitative-heart-fda-510k.jpg K940236 - QUANTITATIVE HEART K940236 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 1994. https://www.510kdatabase.net/k940721/ 1994-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k940721-clinix-vp-4-table-fda-510k.jpg K940721 - CLINIX VP 4 TABLE K940721 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared May 1994. https://www.510kdatabase.net/k932884/ 1994-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k932884-minixminix-st-pulse-generators-fda-510k.jpg K932884 - MINIX/MINIX ST PULSE GENERATORS K932884 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared May 1994. https://www.510kdatabase.net/k933055/ 1994-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k933055-medtronisr-pacing-leads-and-lead-fda-510k.jpg K933055 - MEDTRONIS(R) PACING LEADS AND LEAD ADAPTORS, MODIF K933055 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared May 1994. https://www.510kdatabase.net/k940058/ 1994-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k940058-monoject-blood-collection-tubes-fda-510k.jpg K940058 - MONOJECT BLOOD COLLECTION TUBES W/SAFETY STOPPER K940058 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sherwood Medical Co.. Cleared May 1994. https://www.510kdatabase.net/k940062/ 1994-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k940062-diastat-vascular-access-graft-fda-510k.jpg K940062 - DIASTAT VASCULAR ACCESS GRAFT K940062 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared May 1994. https://www.510kdatabase.net/k940844/ 1994-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k940844-myoma-drill-5mm-8383611-fda-510k.jpg K940844 - MYOMA DRILL 5MM-8383.611 K940844 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared May 1994. https://www.510kdatabase.net/k941245/ 1994-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k941245-poly-medics-heat-pack-fda-510k.jpg K941245 - POLY-MEDICS HEAT PACK K941245 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Biomet, Inc.. Cleared May 1994. https://www.510kdatabase.net/k930347/ 1994-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k930347-shaids-protective-glasses-fda-510k.jpg K930347 - SHAIDS PROTECTIVE GLASSES K930347 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Depuy, Inc.. Cleared Apr 1994. https://www.510kdatabase.net/k930891/ 1994-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k930891-synthes-usa-univ-spine-rodsacral-screw-fda-510k.jpg K930891 - SYNTHES (USA) UNIV SPINE ROD/SACRAL SCREW FIX SYST K930891 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Apr 1994. https://www.510kdatabase.net/k934253/ 1994-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k934253-exactech-all-poly-acetabular-cup-fda-510k.jpg K934253 - EXACTECH ALL POLY ACETABULAR CUP K934253 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Apr 1994. https://www.510kdatabase.net/k934765/ 1994-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k934765-trilogy-acetabular-system-fda-510k.jpg K934765 - TRILOGY ACETABULAR SYSTEM K934765 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Apr 1994. https://www.510kdatabase.net/k936116/ 1994-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k936116-kodak-ektascan-network-interfacefor-fda-510k.jpg K936116 - KODAK EKTASCAN NETWORK INTERFACE/FOR OTHER MANUFACTURERS K936116 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Apr 1994. https://www.510kdatabase.net/k940459/ 1994-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k940459-multipurpose-resin-cement-with-fda-510k.jpg K940459 - MULTIPURPOSE RESIN CEMENT WITH FLUORIDE (MRCF) K940459 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Apr 1994. https://www.510kdatabase.net/k941067/ 1994-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k941067-aurolite-cb-fda-510k.jpg K941067 - AUROLITE CB K941067 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Apr 1994. https://www.510kdatabase.net/k941072/ 1994-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k941072-aurium-pc16-fda-510k.jpg K941072 - AURIUM PC16 K941072 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Apr 1994. https://www.510kdatabase.net/k941097/ 1994-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k941097-aurium-d16-fda-510k.jpg K941097 - AURIUM D16 K941097 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Apr 1994. https://www.510kdatabase.net/k925968/ 1994-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k925968-endoscope-fda-510k.jpg K925968 - ENDOSCOPE K925968 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Apr 1994. https://www.510kdatabase.net/k930416/ 1994-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k930416-surgical-suture-package-inserts-fda-510k.jpg K930416 - SURGICAL SUTURE PACKAGE INSERTS K930416 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Apr 1994. https://www.510kdatabase.net/k934909/ 1994-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k934909-cobalt-chrome-gemini-fda-510k.jpg K934909 - COBALT CHROME GEMINI K934909 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Apr 1994. https://www.510kdatabase.net/k940227/ 1994-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k940227-scpu-x-ray-generator-fda-510k.jpg K940227 - SCPU X-RAY GENERATOR K940227 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Apr 1994. https://www.510kdatabase.net/k940685/ 1994-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k940685-pretreatment-solution-fda-510k.jpg K940685 - PRETREATMENT SOLUTION K940685 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Apr 1994. https://www.510kdatabase.net/k941068/ 1994-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k941068-aurolite-cb80-fda-510k.jpg K941068 - AUROLITE CB80 K941068 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Apr 1994. https://www.510kdatabase.net/k941069/ 1994-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k941069-aurolite-mt1-fda-510k.jpg K941069 - AUROLITE MT1 K941069 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Apr 1994. https://www.510kdatabase.net/k941070/ 1994-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k941070-aurolite-cb2-fda-510k.jpg K941070 - AUROLITE CB+2 K941070 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Apr 1994. https://www.510kdatabase.net/k941071/ 1994-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k941071-aurolite-cb25-fda-510k.jpg K941071 - AUROLITE CB25 K941071 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Apr 1994. https://www.510kdatabase.net/k924392/ 1994-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k924392-cardiac-t-elisa-troponin-t-fda-510k.jpg K924392 - CARDIAC T ELISA TROPONIN-T K924392 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Apr 1994. https://www.510kdatabase.net/k933869/ 1994-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k933869-extension-set-with-022-micron-96-hour-fda-510k.jpg K933869 - EXTENSION SET WITH 0.22 MICRON 96 HOUR FILTER K933869 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Apr 1994. https://www.510kdatabase.net/k934925/ 1994-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k934925-beckman-ammonia-amm-reagent-cx-ammonia-fda-510k.jpg K934925 - BECKMAN AMMONIA AMM REAGENT/ CX AMMONIA CALIBRATOR K934925 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Apr 1994. https://www.510kdatabase.net/k935806/ 1994-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k935806-immulite-dhea-s04-fda-510k.jpg K935806 - IMMULITE DHEA-S04 K935806 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Apr 1994. https://www.510kdatabase.net/k936044/ 1994-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k936044-enhanced-modular-austin-moore-hip-fda-510k.jpg K936044 - ENHANCED MODULAR AUSTIN MOORE HIP K936044 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Apr 1994. https://www.510kdatabase.net/k940702/ 1994-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k940702-convertors-opti-sorb-drape-material-fda-510k.jpg K940702 - CONVERTORS OPTI-SORB DRAPE MATERIAL K940702 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Apr 1994. https://www.510kdatabase.net/k932728/ 1994-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k932728-kodak-ektachem-clinical-chemistry-fda-510k.jpg K932728 - KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (URIC) K932728 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Apr 1994. https://www.510kdatabase.net/k934106/ 1994-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k934106-kodak-ektachem-dtsc-ii-slides-li-fda-510k.jpg K934106 - KODAK EKTACHEM DTSC II SLIDES (LI) K934106 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Eastman Kodak Company. Cleared Apr 1994. https://www.510kdatabase.net/k934413/ 1994-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k934413-kodak-ektachem-clinical-chemistry-fda-510k.jpg K934413 - KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE FOR ASPARATE AMIMOTRANSFERASE K934413 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Apr 1994. https://www.510kdatabase.net/k935071/ 1994-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k935071-insulated-forceps-biopsy-forceps-fda-510k.jpg K935071 - INSULATED FORCEPS, BIOPSY FORCEPS, SCISSORS K935071 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Apr 1994. https://www.510kdatabase.net/k934559/ 1994-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k934559-karl-storz-xenon-light-source-model-fda-510k.jpg K934559 - KARL STORZ XENON LIGHT SOURCE MODEL 201320-20 K934559 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Apr 1994. https://www.510kdatabase.net/k933576/ 1994-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k933576-arthroscope-disposable-fda-510k.jpg K933576 - ARTHROSCOPE, DISPOSABLE K933576 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Apr 1994. https://www.510kdatabase.net/k940353/ 1994-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k940353-beckman-beta-2-microglobulin-b2m-fda-510k.jpg K940353 - BECKMAN BETA-2-MICROGLOBULIN (B2M) K940353 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Apr 1994. https://www.510kdatabase.net/k933457/ 1994-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k933457-rim-ecoli-0157h7-latex-test-fda-510k.jpg K933457 - RIM E.COLI 0157:H7 LATEX TEST K933457 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Apr 1994. https://www.510kdatabase.net/k940310/ 1994-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k940310-helena-thromboplastin-mi-reagent-fda-510k.jpg K940310 - HELENA THROMBOPLASTIN-MI REAGENT K940310 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Apr 1994. https://www.510kdatabase.net/k940900/ 1994-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k940900-appendix-extractor-838550-fda-510k.jpg K940900 - APPENDIX EXTRACTOR 8385.50 K940900 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Apr 1994. https://www.510kdatabase.net/k933125/ 1994-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k933125-berichrom-antithrombin-iii-a-fda-510k.jpg K933125 - BERICHROM ANTITHROMBIN III (A) K933125 is a FDA 510(k) cleared hematology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Apr 1994. https://www.510kdatabase.net/k934326/ 1994-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k934326-multifibren-u-fda-510k.jpg K934326 - MULTIFIBREN U K934326 is a FDA 510(k) cleared hematology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Apr 1994. https://www.510kdatabase.net/k940484/ 1994-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k940484-coroskop-hi-p-angiographic-x-ray-system-fda-510k.jpg K940484 - COROSKOP HI-P ANGIOGRAPHIC X-RAY SYSTEM K940484 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 1994. https://www.510kdatabase.net/k940936/ 1994-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k940936-aesculap-endoscopic-instruments-fda-510k.jpg K940936 - AESCULAP ENDOSCOPIC INSTRUMENTS K940936 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Apr 1994. https://www.510kdatabase.net/k926385/ 1994-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k926385-bard-apii-pump-fda-510k.jpg K926385 - BARD APII PUMP K926385 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 1994. https://www.510kdatabase.net/k921119/ 1994-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k921119-arthrex-arthroscope-fda-510k.jpg K921119 - ARTHREX ARTHROSCOPE K921119 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Apr 1994. https://www.510kdatabase.net/k931755/ 1994-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k931755-riwolith-2280-probes-fda-510k.jpg K931755 - RIWOLITH 2280 PROBES K931755 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Apr 1994. https://www.510kdatabase.net/k940075/ 1994-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k940075-shaver-blade-set-fda-510k.jpg K940075 - SHAVER BLADE SET K940075 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Apr 1994. https://www.510kdatabase.net/k940678/ 1994-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k940678-autotransfusion-suction-reservoir-with-fda-510k.jpg K940678 - AUTOTRANSFUSION SUCTION RESERVOIR WITH FILTER K940678 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Apr 1994. https://www.510kdatabase.net/k922527/ 1994-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k922527-bard-urodynamic-catheterization-fda-510k.jpg K922527 - BARD URODYNAMIC CATHETERIZATION PROCEDURE TRAY K922527 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 1994. https://www.510kdatabase.net/k933787/ 1994-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k933787-porocoat-porous-coatingaml-proximally-fda-510k.jpg K933787 - POROCOAT POROUS COATING/AML PROXIMALLY-COATED STEM K933787 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Apr 1994. https://www.510kdatabase.net/k941024/ 1994-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k941024-aesculap-trocar-collar-fda-510k.jpg K941024 - AESCULAP TROCAR COLLAR K941024 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Apr 1994. https://www.510kdatabase.net/k934196/ 1994-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k934196-codman-quick-shunt-kit-cat-82-6570-fda-510k.jpg K934196 - CODMAN QUICK SHUNT KIT, CAT. #82-6570 K934196 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Apr 1994. https://www.510kdatabase.net/k924101/ 1994-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k924101-sterile-convertors-sms-polypropylene-fda-510k.jpg K924101 - STERILE CONVERTORS SMS POLYPROPYLENE GOWN & DRAPE K924101 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Apr 1994. https://www.510kdatabase.net/k941092/ 1994-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k941092-murdoch-laparoscope-lens-cleaner-fda-510k.jpg K941092 - MURDOCH LAPAROSCOPE LENS CLEANER K941092 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cook, Inc.. Cleared Apr 1994. https://www.510kdatabase.net/k936138/ 1994-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k936138-kodak-surecell-hcg-serumurine-test-kit-fda-510k.jpg K936138 - KODAK SURECELL HCG-SERUM/URINE TEST KIT, MODIFICATION K936138 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Apr 1994. https://www.510kdatabase.net/k936287/ 1994-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k936287-kodak-surecell-hcg-urine-test-fda-510k.jpg K936287 - KODAK SURECELL HCG URINE TEST, MODIFICATION K936287 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Apr 1994. https://www.510kdatabase.net/k924985/ 1994-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k924985-computerized-tomography-x-ray-system-fda-510k.jpg K924985 - COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION K924985 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 1994. https://www.510kdatabase.net/k940398/ 1994-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k940398-auto-suture-laparoscopic-fascia-fda-510k.jpg K940398 - AUTO SUTURE LAPAROSCOPIC FASCIA CLOSURE DEVICE II K940398 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Apr 1994. https://www.510kdatabase.net/k940800/ 1994-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k940800-dentacolor-vita-vs-shade-system-fda-510k.jpg K940800 - DENTACOLOR VITA (VS) SHADE SYSTEM K940800 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Apr 1994. https://www.510kdatabase.net/k934135/ 1994-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k934135-emit-2000-digoxin-assaycalibrators-fda-510k.jpg K934135 - EMIT 2000 DIGOXIN ASSAY/CALIBRATORS MODIFICATION K934135 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Apr 1994. https://www.510kdatabase.net/k934841/ 1994-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k934841-urinarycerebrospinal-fluid-protein-fda-510k.jpg K934841 - URINARY/CEREBROSPINAL FLUID PROTEIN K934841 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Apr 1994. https://www.510kdatabase.net/k935119/ 1994-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k935119-radias-3rd-generation-tsh-immunoassay-fda-510k.jpg K935119 - RADIAS 3RD GENERATION TSH IMMUNOASSAY K935119 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Apr 1994. https://www.510kdatabase.net/k935613/ 1994-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k935613-radias-monoclonal-hba-1c-assay-fda-510k.jpg K935613 - RADIAS MONOCLONAL HBA 1C ASSAY K935613 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bio-Rad. Cleared Apr 1994. https://www.510kdatabase.net/k940930/ 1994-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k940930-aurium-g14-fda-510k.jpg K940930 - AURIUM G14 K940930 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Apr 1994. https://www.510kdatabase.net/k932077/ 1994-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k932077-model-151-fetal-monitor-fda-510k.jpg K932077 - MODEL 151 FETAL MONITOR K932077 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Mar 1994. https://www.510kdatabase.net/k940865/ 1994-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k940865-aurium-d17-high-gold-crown-bridge-alloy-fda-510k.jpg K940865 - AURIUM D17 (HIGH GOLD CROWN & BRIDGE ALLOY) K940865 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k940929/ 1994-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k940929-aurium-50y-fda-510k.jpg K940929 - AURIUM 50Y K940929 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k941002/ 1994-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k941002-aurium-x6-medium-gold-crown-and-bridge-fda-510k.jpg K941002 - AURIUM X6 (MEDIUM GOLD CROWN AND BRIDGE ALLOY) K941002 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k941003/ 1994-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k941003-aurium-20-low-gold-crown-and-bridge-fda-510k.jpg K941003 - AURIUM 20% (LOW GOLD CROWN AND BRIDGE ALLOY) K941003 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k931117/ 1994-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k931117-assesstm-low-abnormal-control-fda-510k.jpg K931117 - ASSESS(TM) LOW ABNORMAL CONTROL K931117 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Mar 1994. https://www.510kdatabase.net/k931118/ 1994-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k931118-assesstm-high-abnormal-control-fda-510k.jpg K931118 - ASSESS(TM) HIGH ABNORMAL CONTROL K931118 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Mar 1994. https://www.510kdatabase.net/k922519/ 1994-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k922519-mod-percutaneous-arthroscopic-micro-fda-510k.jpg K922519 - MOD. PERCUTANEOUS ARTHROSCOPIC MICRO DISCECTOMY K922519 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k935627/ 1994-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k935627-cp-body-array-cp-spine-array-coil-fda-510k.jpg K935627 - CP BODY ARRAY/ CP SPINE ARRAY COIL K935627 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k935752/ 1994-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k935752-cp-flexible-coils-lp-circular-flex-coils-fda-510k.jpg K935752 - CP FLEXIBLE COILS/ LP CIRCULAR FLEX COILS K935752 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k940300/ 1994-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k940300-magellan-fda-510k.jpg K940300 - MAGELLAN K940300 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Mar 1994. https://www.510kdatabase.net/k940789/ 1994-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k940789-aurium-c-fda-510k.jpg K940789 - AURIUM C K940789 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k940856/ 1994-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k940856-aurium-g13-high-gold-crown-and-bridge-fda-510k.jpg K940856 - AURIUM G13 (HIGH GOLD CROWN AND BRIDGE ALLOY) K940856 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k921756/ 1994-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k921756-electronic-insufflator-model-205461-fda-510k.jpg K921756 - ELECTRONIC INSUFFLATOR MODEL 2054.61 K921756 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Mar 1994. https://www.510kdatabase.net/k921818/ 1994-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k921818-abbott-smart-cap-fda-510k.jpg K921818 - ABBOTT SMART CAP K921818 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1994. https://www.510kdatabase.net/k931116/ 1994-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k931116-il-testtm-triglyceride-fda-510k.jpg K931116 - IL TEST(TM) TRIGLYCERIDE K931116 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Mar 1994. https://www.510kdatabase.net/k933326/ 1994-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k933326-lifecare-plumset-vented-secondary-iv-set-fda-510k.jpg K933326 - LIFECARE PLUMSET VENTED SECONDARY I.V. SET K933326 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1994. https://www.510kdatabase.net/k935069/ 1994-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k935069-il1430-bgelectrolyte-analyzer-fda-510k.jpg K935069 - IL1430 BGELECTROLYTE ANALYZER K935069 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Mar 1994. https://www.510kdatabase.net/k940761/ 1994-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k940761-aurium-22kt-fda-510k.jpg K940761 - AURIUM 22KT K940761 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k940779/ 1994-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k940779-aurium-d4-fda-510k.jpg K940779 - AURIUM D4 K940779 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k940787/ 1994-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k940787-aurium-b4-fda-510k.jpg K940787 - AURIUM B4 K940787 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k940788/ 1994-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k940788-aurium-830-fda-510k.jpg K940788 - AURIUM 830 K940788 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k940855/ 1994-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k940855-aurium-sg-high-gold-crown-and-bridge-fda-510k.jpg K940855 - AURIUM SG (HIGH GOLD CROWN AND BRIDGE ALLOY) K940855 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k934720/ 1994-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k934720-auto-suture-disposable-arthroscopic-fda-510k.jpg K934720 - AUTO SUTURE DISPOSABLE ARTHROSCOPIC TROCAR AND SLEEVE K934720 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Mar 1994. https://www.510kdatabase.net/k934798/ 1994-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k934798-pathodx-cytomegalovirus-fda-510k.jpg K934798 - PATHODX CYTOMEGALOVIRUS K934798 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Mar 1994. https://www.510kdatabase.net/k913468/ 1994-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k913468-uldall-double-lumen-hemodialysis-fda-510k.jpg K913468 - ULDALL DOUBLE LUMEN HEMODIALYSIS CATHETER SET/TRAY K913468 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k933070/ 1994-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k933070-arthtotek-precision-hand-instrumentation-fda-510k.jpg K933070 - ARTHTOTEK PRECISION HAND INSTRUMENTATION K933070 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k934401/ 1994-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k934401-arthrotek-cannula-system-fda-510k.jpg K934401 - ARTHROTEK CANNULA SYSTEM K934401 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k933084/ 1994-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k933084-check-valve-fitting-fda-510k.jpg K933084 - CHECK VALVE (FITTING) K933084 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k933994/ 1994-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k933994-arthrex-tourniquet-for-leg-holder-fda-510k.jpg K933994 - ARTHREX TOURNIQUET FOR LEG HOLDER K933994 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Arthrex, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k934937/ 1994-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k934937-karl-storz-biopbask-cutgrasp-fda-510k.jpg K934937 - KARL STORZ BIOP/BASK CUT/GRASP DISSEC/FLEX/CUT FORC K934937 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k936206/ 1994-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k936206-gore-smoother-crucial-tool-fda-510k.jpg K936206 - GORE SMOOTHER CRUCIAL TOOL K936206 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k933277/ 1994-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k933277-coagulation-arp-fda-510k.jpg K933277 - COAGULATION A.R.P. K933277 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Mar 1994. https://www.510kdatabase.net/k935488/ 1994-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k935488-alatopr-microplate-allergy-screen-fda-510k.jpg K935488 - ALATOP(R) MICROPLATE ALLERGY SCREEN K935488 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Mar 1994. https://www.510kdatabase.net/k935543/ 1994-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k935543-aca-plus-ferritin-calibrator-fda-510k.jpg K935543 - ACA PLUS FERRITIN CALIBRATOR K935543 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k940558/ 1994-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k940558-3m-xp-2000-x-ray-film-processor-fda-510k.jpg K940558 - 3M XP-2000 X-RAY FILM PROCESSOR K940558 is a FDA 510(k) cleared radiology medical device. Manufacturer: 3M Company. Cleared Mar 1994. https://www.510kdatabase.net/k940575/ 1994-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k940575-aspir-pulsetm-saf-t-vent-fda-510k.jpg K940575 - ASPIR-PULSE(TM) SAF-T-VENT K940575 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sherwood Medical Co.. Cleared Mar 1994. https://www.510kdatabase.net/k940747/ 1994-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k940747-silfree-79-fda-510k.jpg K940747 - SILFREE 79 K940747 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k931641/ 1994-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k931641-porocoat-porous-coating-fda-510k.jpg K931641 - POROCOAT POROUS COATING K931641 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k933731/ 1994-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k933731-medtronic-model-5028-target-tip-fda-510k.jpg K933731 - MEDTRONIC MODEL 5028 TARGET TIP, BIPOLAR, IMPLANTABLE, TINED, VENTRICULAR, TRANSVENOUS LEAD K933731 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Mar 1994. https://www.510kdatabase.net/k934071/ 1994-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k934071-kodak-ektachem-dt-slides-urcr-fda-510k.jpg K934071 - KODAK EKTACHEM DT SLIDES (URCR) K934071 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Mar 1994. https://www.510kdatabase.net/k934273/ 1994-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k934273-kodak-ektachem-clinical-chemistry-fda-510k.jpg K934273 - KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE ALCOHOL (ALC) K934273 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Eastman Kodak Company. Cleared Mar 1994. https://www.510kdatabase.net/k934350/ 1994-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k934350-kodak-x-omat-m43a-m43-clinic-1-fda-510k.jpg K934350 - KODAK X-OMAT M43A, M43, & CLINIC 1 PROCESSORS K934350 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Mar 1994. https://www.510kdatabase.net/k934358/ 1994-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k934358-kodak-ektachem-dt-slides-fe-fda-510k.jpg K934358 - KODAK EKTACHEM DT SLIDES (FE) K934358 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Mar 1994. https://www.510kdatabase.net/k940617/ 1994-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k940617-surefire-12-fda-510k.jpg K940617 - SUREFIRE 12 K940617 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k940618/ 1994-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k940618-aurolite-41-fda-510k.jpg K940618 - AUROLITE 41 K940618 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k940619/ 1994-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k940619-silfree-79-fda-510k.jpg K940619 - SILFREE 79+ K940619 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k940719/ 1994-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k940719-silfree-fda-510k.jpg K940719 - SILFREE K940719 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k933949/ 1994-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k933949-disposable-arthroscopic-accessory-fda-510k.jpg K933949 - DISPOSABLE ARTHROSCOPIC ACCESSORY K933949 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Mar 1994. https://www.510kdatabase.net/k940485/ 1994-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k940485-aurolite-2a-fda-510k.jpg K940485 - AUROLITE 2A K940485 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k940579/ 1994-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k940579-aurium-239-fda-510k.jpg K940579 - AURIUM 239 K940579 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k940580/ 1994-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k940580-aurolite-6-fda-510k.jpg K940580 - AUROLITE 6 K940580 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k940610/ 1994-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k940610-aurolite-9-fda-510k.jpg K940610 - AUROLITE 9 K940610 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k934738/ 1994-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k934738-autosuture-endoscopic-suturing-device-fda-510k.jpg K934738 - AUTOSUTURE ENDOSCOPIC SUTURING DEVICE K934738 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Mar 1994. https://www.510kdatabase.net/k935304/ 1994-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k935304-3m-dental-electronic-anesthesia-dea-fda-510k.jpg K935304 - 3M DENTAL ELECTRONIC ANESTHESIA (DEA) SYSTEM 8670 K935304 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Mar 1994. https://www.510kdatabase.net/k935661/ 1994-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k935661-magnetom-open-fda-510k.jpg K935661 - MAGNETOM OPEN K935661 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k936180/ 1994-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k936180-tc-system-tilting-c-arm-system-fda-510k.jpg K936180 - TC+ SYSTEM (TILTING C-ARM SYSTEM) K936180 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Mar 1994. https://www.510kdatabase.net/k924436/ 1994-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k924436-bard-urotrack-ii-monitoring-fda-510k.jpg K924436 - BARD UROTRACK II MONITORING K924436 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k930768/ 1994-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k930768-orion-diagnostic-ultrasound-system-fda-510k.jpg K930768 - ORION DIAGNOSTIC ULTRASOUND SYSTEM K930768 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Mar 1994. https://www.510kdatabase.net/k931205/ 1994-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k931205-medi-vac-specimen-collector-and-fda-510k.jpg K931205 - MEDI VAC SPECIMEN COLLECTOR AND TRANSPORTER K931205 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 1994. https://www.510kdatabase.net/k935057/ 1994-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k935057-factor-viii-deficient-plasma-fda-510k.jpg K935057 - FACTOR VIII DEFICIENT PLASMA K935057 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k936032/ 1994-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k936032-torque-device-fda-510k.jpg K936032 - TORQUE DEVICE K936032 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k933518/ 1994-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k933518-synthes-unreamed-humeral-nail-urhn-fda-510k.jpg K933518 - SYNTHES UNREAMED HUMERAL NAIL (URHN) K933518 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Mar 1994. https://www.510kdatabase.net/k934671/ 1994-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k934671-hi-flo-infusion-pump-fda-510k.jpg K934671 - HI-FLO INFUSION PUMP K934671 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1994. https://www.510kdatabase.net/k935814/ 1994-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k935814-microvasivermeditechr-asaptm-14g-fda-510k.jpg K935814 - MICROVASIVE(R)/MEDITECH(R) ASAP(TM) 14G BIOPSY NEEDLE K935814 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Mar 1994. https://www.510kdatabase.net/k915857/ 1994-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k915857-flexible-tip-thoracoscopelaparoscope-fda-510k.jpg K915857 - FLEXIBLE TIP THORACOSCOPE/LAPAROSCOPE K915857 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Olympus Corp.. Cleared Mar 1994. https://www.510kdatabase.net/k930152/ 1994-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k930152-arthrex-tibial-tunnel-cannula-fda-510k.jpg K930152 - ARTHREX TIBIAL TUNNEL CANNULA K930152 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k930934/ 1994-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k930934-endopath-reloadable-linear-cutter-fda-510k.jpg K930934 - ENDOPATH RELOADABLE LINEAR CUTTER K930934 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ethicon, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k933008/ 1994-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k933008-retractors-and-scraper-fda-510k.jpg K933008 - RETRACTORS AND SCRAPER K933008 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 1994. https://www.510kdatabase.net/k933678/ 1994-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k933678-sigma-calcium-reagent-fda-510k.jpg K933678 - SIGMA CALCIUM REAGENT K933678 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Mar 1994. https://www.510kdatabase.net/k934843/ 1994-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k934843-urinarycebrospinal-fluid-protein-fda-510k.jpg K934843 - URINARY/CEBROSPINAL FLUID PROTEIN CALIBRATOR K934843 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k936130/ 1994-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k936130-cobas-fp-reagent-for-phenobarbital-and-fda-510k.jpg K936130 - COBAS-FP REAGENT FOR PHENOBARBITAL AND COBAS-FP PHENOBARBITAL CALIBRATORS K936130 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k936131/ 1994-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k936131-cobas-fp-reagent-for-phenytoin-and-fda-510k.jpg K936131 - COBAS-FP REAGENT FOR PHENYTOIN AND COBA-FP PHENYTOIN CALIBRATORS K936131 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k922796/ 1994-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k922796-pelvic-c-clamp-fda-510k.jpg K922796 - PELVIC C-CLAMP K922796 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Mar 1994. https://www.510kdatabase.net/k925345/ 1994-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k925345-ziconia-ceramic-mod-headtype-i-taper-fda-510k.jpg K925345 - ZICONIA CERAMIC MOD HEAD(TYPE I TAPER 28/32, +6MM) K925345 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k925460/ 1994-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k925460-synthes-sterile-pinless-external-fixator-fda-510k.jpg K925460 - SYNTHES STERILE PINLESS EXTERNAL FIXATOR K925460 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Mar 1994. https://www.510kdatabase.net/k926395/ 1994-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k926395-elitetm-zirconia-total-hip-ball-head-fda-510k.jpg K926395 - ELITE(TM) ZIRCONIA TOTAL HIP BALL HEAD SYSTEM K926395 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k932519/ 1994-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k932519-osteonicsr-omnifitr-normalized-hip-stem-fda-510k.jpg K932519 - OSTEONICS(R) OMNIFIT(R) NORMALIZED HIP STEM K932519 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Mar 1994. https://www.510kdatabase.net/k932593/ 1994-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k932593-access-to-synthes-ti-6a1-7nb-unreamed-fda-510k.jpg K932593 - ACCESS TO SYNTHES TI-6A1-7NB UNREAMED FEMORAL NAIL K932593 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Mar 1994. https://www.510kdatabase.net/k936186/ 1994-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k936186-aesculap-skin-graft-mesher-fda-510k.jpg K936186 - AESCULAP SKIN GRAFT MESHER K936186 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k933561/ 1994-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k933561-osteonics-omnifit-forged-hip-stem-series-fda-510k.jpg K933561 - OSTEONICS OMNIFIT FORGED HIP STEM SERIES K933561 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Mar 1994. https://www.510kdatabase.net/k934174/ 1994-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k934174-ligaclip-endoscopic-rotating-multiple-fda-510k.jpg K934174 - LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER K934174 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k914479/ 1994-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k914479-microsensor-intracranial-pressure-fda-510k.jpg K914479 - MICROSENSOR INTRACRANIAL PRESSURE TRANSDUCER K914479 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k915649/ 1994-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k915649-bard-500ml-reservoir-holder-fda-510k.jpg K915649 - BARD 500ML RESERVOIR HOLDER K915649 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k932174/ 1994-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k932174-gamma-locking-nail-cross-locking-screws-fda-510k.jpg K932174 - GAMMA LOCKING NAIL-CROSS LOCKING SCREWS K932174 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Mar 1994. https://www.510kdatabase.net/k933359/ 1994-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k933359-osteonics-22mm-10-neck-bearing-heads-fda-510k.jpg K933359 - OSTEONICS 22MM, +10 NECK BEARING HEADS K933359 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Mar 1994. https://www.510kdatabase.net/k933570/ 1994-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k933570-resolutiontm-hip-stem-fda-510k.jpg K933570 - RESOLUTION(TM) HIP STEM K933570 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Mar 1994. https://www.510kdatabase.net/k934883/ 1994-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k934883-3d-video-system-fda-510k.jpg K934883 - 3D VIDEO SYSTEM K934883 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Mar 1994. https://www.510kdatabase.net/k935054/ 1994-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k935054-factor-x-deficient-plasma-fda-510k.jpg K935054 - FACTOR X DEFICIENT PLASMA K935054 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k935056/ 1994-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k935056-factor-vii-deficient-plasma-fda-510k.jpg K935056 - FACTOR VII DEFICIENT PLASMA K935056 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k935058/ 1994-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k935058-factor-fda-510k.jpg K935058 - FACTOR K935058 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k935694/ 1994-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k935694-sienet-diagnostic-reporting-console-fda-510k.jpg K935694 - SIENET DIAGNOSTIC REPORTING CONSOLE VA02 UPGRADE K935694 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k935735/ 1994-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k935735-attachment-bond-fda-510k.jpg K935735 - ATTACHMENT BOND K935735 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k940361/ 1994-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k940361-aurolite-1c-fda-510k.jpg K940361 - AUROLITE 1C K940361 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k940434/ 1994-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k940434-aurolite-2b-fda-510k.jpg K940434 - AUROLITE 2B K940434 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k940435/ 1994-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k940435-aurolite-542-fda-510k.jpg K940435 - AUROLITE 54+2 K940435 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k923065/ 1994-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k923065-baxter-personal-cycler-autommated-fda-510k.jpg K923065 - BAXTER PERSONAL CYCLER AUTOMMATED PERITONEAL DIAL K923065 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 1994. https://www.510kdatabase.net/k931460/ 1994-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k931460-vectra-mobile-magnetic-resonance-fda-510k.jpg K931460 - VECTRA MOBILE MAGNETIC RESONANCE IMAGING SYSTEM K931460 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Mar 1994. https://www.510kdatabase.net/k932129/ 1994-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k932129-3m-autoclave-tapes-fda-510k.jpg K932129 - 3M AUTOCLAVE TAPES K932129 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Mar 1994. https://www.510kdatabase.net/k934784/ 1994-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k934784-endopath-endoscopic-electrosurgical-fda-510k.jpg K934784 - ENDOPATH ENDOSCOPIC ELECTROSURGICAL FORCEPS WITH CUTTING FEATURE K934784 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k940282/ 1994-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k940282-surefire-10-fda-510k.jpg K940282 - SUREFIRE 10 K940282 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k940337/ 1994-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k940337-silfree-2-high-palladium-alloy-for-fda-510k.jpg K940337 - SILFREE 2 HIGH-PALLADIUM ALLOY FOR PORCELAIN APPLICATION K940337 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k940341/ 1994-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k940341-aurolite-1k-fda-510k.jpg K940341 - AUROLITE 1K K940341 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k940342/ 1994-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k940342-surefire-w-fda-510k.jpg K940342 - SUREFIRE W K940342 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k940343/ 1994-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k940343-aurolite-1b-fda-510k.jpg K940343 - AUROLITE 1B K940343 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k940360/ 1994-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k940360-aurolite-85-fda-510k.jpg K940360 - AUROLITE 85 K940360 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k930187/ 1994-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k930187-osteonicsr-arc-depositioned-femoral-fda-510k.jpg K930187 - OSTEONICS(R) ARC DEPOSITIONED FEMORAL COMPONENTS K930187 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Mar 1994. https://www.510kdatabase.net/k935731/ 1994-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k935731-acetabular-shell-fda-510k.jpg K935731 - ACETABULAR SHELL K935731 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Mar 1994. https://www.510kdatabase.net/k925810/ 1994-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k925810-cordis-polypropylene-burr-hole-reservoir-fda-510k.jpg K925810 - CORDIS POLYPROPYLENE BURR HOLE RESERVOIR K925810 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cordis Corp.. Cleared Mar 1994. https://www.510kdatabase.net/k922394/ 1994-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k922394-cardiofax-q-ecg-8420a-fda-510k.jpg K922394 - CARDIOFAX Q ECG-8420A K922394 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k925153/ 1994-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k925153-it-7-femoral-component-anatomic-hip-fda-510k.jpg K925153 - IT-7 FEMORAL COMPONENT, ANATOMIC HIP SYSTEM K925153 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Mar 1994. https://www.510kdatabase.net/k931524/ 1994-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k931524-fully-threaded-alta-cancellous-bone-fda-510k.jpg K931524 - FULLY THREADED ALTA CANCELLOUS BONE SCREW K931524 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Mar 1994. https://www.510kdatabase.net/k933713/ 1994-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k933713-venous-reserviorcardiotomy-fda-510k.jpg K933713 - VENOUS RESERVIOR/CARDIOTOMY AUTOTRANSFUSION FILTER WITH DURAFLO II HEPARIN TREATMENT K933713 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 1994. https://www.510kdatabase.net/k933875/ 1994-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k933875-premise-cemented-femoral-stem-addition-fda-510k.jpg K933875 - PREMISE CEMENTED FEMORAL STEM, ADDITION STYLE K933875 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Mar 1994. https://www.510kdatabase.net/k940252/ 1994-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k940252-finesse-porcelain-system-fda-510k.jpg K940252 - FINESSE PORCELAIN SYSTEM K940252 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Mar 1994. https://www.510kdatabase.net/k940280/ 1994-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k940280-surefire-a-fda-510k.jpg K940280 - SUREFIRE A K940280 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k940281/ 1994-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k940281-argedent-51sf-fda-510k.jpg K940281 - ARGEDENT 51SF K940281 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Mar 1994. https://www.510kdatabase.net/k930217/ 1994-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k930217-baxter-disposable-intraosseous-fda-510k.jpg K930217 - BAXTER DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE K930217 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Feb 1994. https://www.510kdatabase.net/k940278/ 1994-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k940278-aurium-j-fda-510k.jpg K940278 - AURIUM J K940278 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Feb 1994. https://www.510kdatabase.net/k934557/ 1994-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k934557-control-cable-system-fda-510k.jpg K934557 - CONTROL CABLE SYSTEM K934557 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Feb 1994. https://www.510kdatabase.net/k935124/ 1994-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k935124-bacticard-candida-fda-510k.jpg K935124 - BACTICARD CANDIDA K935124 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Feb 1994. https://www.510kdatabase.net/k940327/ 1994-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k940327-intervent-allergen-exclusion-fda-510k.jpg K940327 - INTERVENT ALLERGEN EXCLUSION TECHNOLOGY, INTERVENT BEDDING SYSTEM, INTERVENT MATTRESS INTERLINER, INTERVIEW PILLOW K940327 is a FDA 510(k) cleared general hospital medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Feb 1994. https://www.510kdatabase.net/k923224/ 1994-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k923224-kvoiv-flush-system-fda-510k.jpg K923224 - KVOI.V. FLUSH SYSTEM K923224 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Feb 1994. https://www.510kdatabase.net/k930982/ 1994-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k930982-illusion-steerable-microguidewire-for-fda-510k.jpg K930982 - ILLUSION STEERABLE MICROGUIDEWIRE FOR NEUROVAC USE K930982 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Feb 1994. https://www.510kdatabase.net/k933510/ 1994-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k933510-argyle-turkel-safety-trocar-thoracic-fda-510k.jpg K933510 - ARGYLE TURKEL SAFETY TROCAR THORACIC CATHETER K933510 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sherwood Medical Co.. Cleared Feb 1994. https://www.510kdatabase.net/k935863/ 1994-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k935863-sastm-direct-monoclonal-hcg-fda-510k.jpg K935863 - SAS(TM) DIRECT MONOCLONAL HCG K935863 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sa Scientific, Inc.. Cleared Feb 1994. https://www.510kdatabase.net/k935869/ 1994-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k935869-dextrentm-powder-free-hypoallergenic-fda-510k.jpg K935869 - DEXTREN(TM) POWDER FREE HYPOALLERGENIC GLOVES K935869 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Feb 1994. https://www.510kdatabase.net/k940208/ 1994-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k940208-aesculap-accu-dermatome-fda-510k.jpg K940208 - AESCULAP ACCU-DERMATOME K940208 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Feb 1994. https://www.510kdatabase.net/k903630/ 1994-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k903630-precision-osteoflex-femoral-component-fda-510k.jpg K903630 - PRECISION OSTEOFLEX FEMORAL COMPONENT K903630 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Feb 1994. https://www.510kdatabase.net/k933738/ 1994-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k933738-m-kurosaka-interference-fixation-screw-fda-510k.jpg K933738 - M. KUROSAKA INTERFERENCE FIXATION SCREW K933738 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Feb 1994. https://www.510kdatabase.net/k933871/ 1994-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k933871-bridgetm-hip-system-fda-510k.jpg K933871 - BRIDGE(TM) HIP SYSTEM K933871 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Feb 1994. https://www.510kdatabase.net/k934058/ 1994-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k934058-dall-miles-system-minicleat-fda-510k.jpg K934058 - DALL MILES SYSTEM MINICLEAT K934058 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Feb 1994. https://www.510kdatabase.net/k934469/ 1994-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k934469-arthrotek-interference-screw-fda-510k.jpg K934469 - ARTHROTEK INTERFERENCE SCREW K934469 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Feb 1994. https://www.510kdatabase.net/k934986/ 1994-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k934986-bacticard-e-coli-fda-510k.jpg K934986 - BACTICARD E. COLI K934986 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Feb 1994. https://www.510kdatabase.net/k935448/ 1994-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k935448-luhr-mini-bone-screw-and-z-plate-fda-510k.jpg K935448 - LUHR MINI BONE SCREW AND Z PLATE K935448 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Feb 1994. https://www.510kdatabase.net/k921308/ 1994-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k921308-hg-multilock-hip-prosthesis-w-ti-nidium-fda-510k.jpg K921308 - HG MULTILOCK HIP PROSTHESIS W/ TI-NIDIUM K921308 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Feb 1994. https://www.510kdatabase.net/k921557/ 1994-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k921557-bias-total-hip-system-acetabular-fda-510k.jpg K921557 - BIAS TOTAL HIP SYSTEM ACETABULAR COMPONENT K921557 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Feb 1994. https://www.510kdatabase.net/k922071/ 1994-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k922071-zimmer-anatomic-hip-system-fda-510k.jpg K922071 - ZIMMER ANATOMIC HIP SYSTEM K922071 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Feb 1994. https://www.510kdatabase.net/k924401/ 1994-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k924401-pathoplasmar-i-ii-path-citrated-human-fda-510k.jpg K924401 - PATHOPLASMA(R) I & II (PATH CITRATED HUMAN PLASMA) K924401 is a FDA 510(k) cleared hematology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Feb 1994. https://www.510kdatabase.net/k924402/ 1994-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k924402-control-plasma-u-fda-510k.jpg K924402 - CONTROL PLASMA U K924402 is a FDA 510(k) cleared hematology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Feb 1994. https://www.510kdatabase.net/k924403/ 1994-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k924403-control-plasma-n-fda-510k.jpg K924403 - CONTROL PLASMA N K924403 is a FDA 510(k) cleared hematology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Feb 1994. https://www.510kdatabase.net/k924482/ 1994-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k924482-howmedical-total-knee-stem-extender-fda-510k.jpg K924482 - HOWMEDICAL TOTAL KNEE STEM EXTENDER K924482 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Feb 1994. https://www.510kdatabase.net/k925172/ 1994-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k925172-pcar-e-series-hip-system-cementless-use-fda-510k.jpg K925172 - PCA(R) E SERIES HIP SYSTEM (CEMENTLESS USE) K925172 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Feb 1994. https://www.510kdatabase.net/k925403/ 1994-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k925403-baxter-apd-12-extension-line-fda-510k.jpg K925403 - BAXTER APD 12' EXTENSION LINE K925403 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Feb 1994. https://www.510kdatabase.net/k926228/ 1994-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k926228-duracon-cruciform-tibial-baseplate-fda-510k.jpg K926228 - DURACON CRUCIFORM TIBIAL BASEPLATE K926228 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Feb 1994. https://www.510kdatabase.net/k926229/ 1994-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k926229-apc-femoral-component-fda-510k.jpg K926229 - APC FEMORAL COMPONENT K926229 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Feb 1994. https://www.510kdatabase.net/k930223/ 1994-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k930223-howmedica-acetabular-shell-fda-510k.jpg K930223 - HOWMEDICA ACETABULAR SHELL K930223 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Feb 1994. https://www.510kdatabase.net/k930460/ 1994-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k930460-howmedica-revision-hip-system-fda-510k.jpg K930460 - HOWMEDICA REVISION HIP SYSTEM K930460 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Feb 1994. https://www.510kdatabase.net/k930833/ 1994-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k930833-pcar-solid-back-acetabula-shell-fda-510k.jpg K930833 - PCA(R) SOLID BACK ACETABULA SHELL K930833 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Feb 1994. https://www.510kdatabase.net/k931675/ 1994-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k931675-medlines-examin-operating-roomsurg-fda-510k.jpg K931675 - MEDLINE'S EXAMIN, OPERATING ROOM/SURG LIGHTS/LAMPS K931675 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medline Industries, Inc.. Cleared Feb 1994. https://www.510kdatabase.net/k932512/ 1994-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k932512-multi-port-manifold-fda-510k.jpg K932512 - MULTI-PORT MANIFOLD K932512 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Feb 1994. https://www.510kdatabase.net/k932654/ 1994-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k932654-electrosurgial-instruments-fda-510k.jpg K932654 - ELECTROSURGIAL INSTRUMENTS K932654 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medline Industries, Inc.. Cleared Feb 1994. https://www.510kdatabase.net/k934440/ 1994-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k934440-pca-acetabular-insert-ii-additional-fda-510k.jpg K934440 - PCA ACETABULAR INSERT II, ADDITIONAL SIZES, STYLES K934440 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Feb 1994. https://www.510kdatabase.net/k934698/ 1994-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k934698-howmedica-mono-tube-single-pin-clamp-fda-510k.jpg K934698 - HOWMEDICA MONO-TUBE SINGLE PIN CLAMP K934698 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Feb 1994. https://www.510kdatabase.net/k935286/ 1994-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k935286-quantaphase-ii-b12folate-fda-510k.jpg K935286 - QUANTAPHASE II B12/FOLATE K935286 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Feb 1994. https://www.510kdatabase.net/k935870/ 1994-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k935870-dextren-powder-free-hypoallerg-gloves-fda-510k.jpg K935870 - DEXTREN POWDER FREE HYPOALLERG GLOVES W/O COLORANTS K935870 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Feb 1994. https://www.510kdatabase.net/k931994/ 1994-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k931994-resectoscope-sheath-fda-510k.jpg K931994 - RESECTOSCOPE SHEATH K931994 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Olympus Corp.. Cleared Feb 1994. https://www.510kdatabase.net/k934985/ 1994-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k934985-endoscopic-high-frequency-monopolar-cord-fda-510k.jpg K934985 - ENDOSCOPIC HIGH FREQUENCY MONOPOLAR CORD K934985 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Feb 1994. https://www.510kdatabase.net/k935086/ 1994-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k935086-auto-suture-disposable-optical-trocar-fda-510k.jpg K935086 - AUTO SUTURE DISPOSABLE OPTICAL TROCAR K935086 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Feb 1994. https://www.510kdatabase.net/k935096/ 1994-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k935096-biolex-impregnated-wound-dressing-fda-510k.jpg K935096 - BIOLEX IMPREGNATED WOUND DRESSING K935096 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Feb 1994. https://www.510kdatabase.net/k935238/ 1994-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k935238-argyle-turkel-safety-paracentesis-fda-510k.jpg K935238 - ARGYLE TURKEL SAFETY PARACENTESIS PROCEDURE TRAY K935238 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Feb 1994. https://www.510kdatabase.net/k921181/ 1994-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k921181-mallory-head-total-hip-system-fda-510k.jpg K921181 - MALLORY-HEAD TOTAL HIP SYSTEM K921181 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Feb 1994. https://www.510kdatabase.net/k921224/ 1994-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k921224-bimetric-total-hip-system-fda-510k.jpg K921224 - BIMETRIC TOTAL HIP SYSTEM K921224 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Feb 1994. https://www.510kdatabase.net/k921225/ 1994-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k921225-integral-total-hip-system-fda-510k.jpg K921225 - INTEGRAL TOTAL HIP SYSTEM K921225 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Feb 1994. https://www.510kdatabase.net/k921277/ 1994-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k921277-ranawatburstein-total-hip-system-fda-510k.jpg K921277 - RANAWAT/BURSTEIN TOTAL HIP SYSTEM K921277 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Feb 1994. https://www.510kdatabase.net/k921301/ 1994-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k921301-taperloc-femoral-stem-and-universal-fda-510k.jpg K921301 - TAPERLOC FEMORAL STEM AND UNIVERSAL ACETABULAR COM K921301 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Feb 1994. https://www.510kdatabase.net/k923452/ 1994-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k923452-pmi-hip-femoral-fda-510k.jpg K923452 - PMI HIP FEMORAL K923452 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Feb 1994. https://www.510kdatabase.net/k940111/ 1994-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k940111-aurium-224-fda-510k.jpg K940111 - AURIUM 224 K940111 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Feb 1994. https://www.510kdatabase.net/k920978/ 1994-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k920978-ula-poliglecaprone-251-synthetic-absor-fda-510k.jpg K920978 - ULA (POLIGLECAPRONE 251) SYNTHETIC ABSOR SUT, DYED K920978 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Feb 1994. https://www.510kdatabase.net/k921274/ 1994-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k921274-metallic-toatal-hip-system-fda-510k.jpg K921274 - METALLIC TOATAL HIP SYSTEM K921274 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Feb 1994. https://www.510kdatabase.net/k931214/ 1994-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k931214-pca-modular-knee-system-fda-510k.jpg K931214 - P.C.A. MODULAR KNEE SYSTEM K931214 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Feb 1994. https://www.510kdatabase.net/k915655/ 1994-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k915655-stability-femoral-prosthesis-whap-fda-510k.jpg K915655 - STABILITY FEMORAL PROSTHESIS W/HAP K915655 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Feb 1994. https://www.510kdatabase.net/k931094/ 1994-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k931094-proceltm-dermaliner-glove-fda-510k.jpg K931094 - PROCEL(TM) DERMALINER GLOVE K931094 is a FDA 510(k) cleared general hospital medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Feb 1994. https://www.510kdatabase.net/k933751/ 1994-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k933751-lifeshield-blood-collection-device-fda-510k.jpg K933751 - LIFESHIELD BLOOD COLLECTION DEVICE K933751 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Feb 1994. https://www.510kdatabase.net/k934525/ 1994-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k934525-auto-suture-disposable-umbilical-clip-fda-510k.jpg K934525 - AUTO SUTURE DISPOSABLE UMBILICAL CLIP APPLIER K934525 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Feb 1994. https://www.510kdatabase.net/k935379/ 1994-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k935379-urological-balloon-dilatation-catheter-fda-510k.jpg K935379 - UROLOGICAL BALLOON DILATATION CATHETER K935379 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Feb 1994. https://www.510kdatabase.net/k930476/ 1994-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k930476-guiding-catheter-fda-510k.jpg K930476 - GUIDING CATHETER K930476 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Feb 1994. https://www.510kdatabase.net/k931258/ 1994-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k931258-softtouch-ii-lancet-device-fda-510k.jpg K931258 - SOFTTOUCH II LANCET DEVICE K931258 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Feb 1994. https://www.510kdatabase.net/k931293/ 1994-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k931293-ssh-140a-fetal-doppler-system-fda-510k.jpg K931293 - SSH-140A FETAL DOPPLER SYSTEM K931293 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Feb 1994. https://www.510kdatabase.net/k933294/ 1994-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k933294-mis-clean-set-flushing-unit-and-fda-510k.jpg K933294 - MIS CLEAN-SET FLUSHING UNIT AND ACCESSORIES K933294 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Aesculap, Inc.. Cleared Feb 1994. https://www.510kdatabase.net/k934647/ 1994-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k934647-karl-storz-cutting-loop-electrodes-fda-510k.jpg K934647 - KARL STORZ CUTTING LOOP ELECTRODES MODIFICATION K934647 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Feb 1994. https://www.510kdatabase.net/k935483/ 1994-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k935483-e-z-prepr-tray-with-hibiclensr-fda-510k.jpg K935483 - E-Z PREP(R) TRAY WITH HIBICLENS(R) K935483 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Feb 1994. https://www.510kdatabase.net/k933586/ 1994-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k933586-minimax-plus-hollow-fiber-oxygenator-fda-510k.jpg K933586 - MINIMAX PLUS HOLLOW FIBER OXYGENATOR (WITH OR WITHOUT MEDTRONIC/CARMEDA BIOACTIVE SURFACE K933586 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Feb 1994. https://www.510kdatabase.net/k935212/ 1994-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k935212-il-test-heparin-xa-pn-84699-15-fda-510k.jpg K935212 - IL TEST HEPARIN (XA), PN 84699-15 K935212 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Feb 1994. https://www.510kdatabase.net/k934404/ 1994-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k934404-monoject-vertical-entry-sharps-container-fda-510k.jpg K934404 - MONOJECT VERTICAL ENTRY SHARPS CONTAINER K934404 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Feb 1994. https://www.510kdatabase.net/k935917/ 1994-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k935917-challenge-powder-free-hypoallergenic-fda-510k.jpg K935917 - CHALLENGE POWDER-FREE, HYPOALLERGENIC, SYNTHETIC SURGICAL GLOVES K935917 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Feb 1994. https://www.510kdatabase.net/k936154/ 1994-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k936154-laparoscopic-trocar-starter-scalpel-fda-510k.jpg K936154 - LAPAROSCOPIC TROCAR STARTER SCALPEL K936154 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Feb 1994. https://www.510kdatabase.net/k932948/ 1994-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k932948-medtronic-model-3625-screener-system-fda-510k.jpg K932948 - MEDTRONIC MODEL 3625 SCREENER SYSTEM K932948 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Feb 1994. https://www.510kdatabase.net/k934088/ 1994-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k934088-auto-suture-sharps-container-fda-510k.jpg K934088 - AUTO SUTURE SHARPS CONTAINER K934088 is a FDA 510(k) cleared general hospital medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Feb 1994. https://www.510kdatabase.net/k923705/ 1994-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k923705-aesculap-craniofacial-titanium-plates-fda-510k.jpg K923705 - AESCULAP CRANIOFACIAL TITANIUM PLATES AND SCREWS K923705 is a FDA 510(k) cleared dental medical device. Manufacturer: Aesculap, Inc.. Cleared Feb 1994. https://www.510kdatabase.net/k931362/ 1994-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k931362-il-test-calcium-fda-510k.jpg K931362 - IL TEST CALCIUM K931362 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Feb 1994. https://www.510kdatabase.net/k932441/ 1994-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k932441-series-8920-trocar-system-fda-510k.jpg K932441 - SERIES 8920 TROCAR SYSTEM K932441 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Feb 1994. https://www.510kdatabase.net/k933011/ 1994-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k933011-microvasive-urological-balloon-fda-510k.jpg K933011 - MICROVASIVE UROLOGICAL BALLOON DILATION CATHETER K933011 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Feb 1994. https://www.510kdatabase.net/k926212/ 1994-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k926212-arthrex-instruments-hip-fda-510k.jpg K926212 - ARTHREX INSTRUMENTS ( HIP ) K926212 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jan 1994. https://www.510kdatabase.net/k933062/ 1994-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k933062-b-dr-challenge-powder-free-synthetic-fda-510k.jpg K933062 - B-D(R) CHALLENGE POWDER FREE SYNTHETIC SURG GLOVES K933062 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jan 1994. https://www.510kdatabase.net/k935073/ 1994-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k935073-non-insulated-scissors-fda-510k.jpg K935073 - NON-INSULATED SCISSORS K935073 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jan 1994. https://www.510kdatabase.net/k935762/ 1994-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k935762-auto-suture-disposable-endoscopic-fda-510k.jpg K935762 - AUTO SUTURE DISPOSABLE ENDOSCOPIC SUTURE NEEDLE K935762 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Jan 1994. https://www.510kdatabase.net/k930822/ 1994-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k930822-gore-tex-soft-tissue-patchsurgical-fda-510k.jpg K930822 - GORE-TEX SOFT TISSUE PATCH,SURGICAL MEMBRANE,MESH K930822 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Jan 1994. https://www.510kdatabase.net/k935528/ 1994-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k935528-dupont-acar-plus-immunoassay-sys-fda-510k.jpg K935528 - DUPONT ACA(R) PLUS IMMUNOASSAY SYS FERRITIN(FERR) METH K935528 is a FDA 510(k) cleared immunology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Jan 1994. https://www.510kdatabase.net/k935973/ 1994-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k935973-argistar-72-high-gold-platinum-silver-fda-510k.jpg K935973 - ARGISTAR 72 (HIGH GOLD PLATINUM SILVER ALLOY FOR BOTH LOW FUSING PORCELAIN AND CROWN AND BRIDGE APPLICATION K935973 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jan 1994. https://www.510kdatabase.net/k930844/ 1994-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k930844-roche-abuscreen-ontrak-pos-ref-control-fda-510k.jpg K930844 - ROCHE ABUSCREEN ONTRAK POS. REF. CONTROL-METHADONE K930844 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jan 1994. https://www.510kdatabase.net/k931701/ 1994-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k931701-immulite-pap-fda-510k.jpg K931701 - IMMULITE PAP K931701 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jan 1994. https://www.510kdatabase.net/k933067/ 1994-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k933067-probesscissorsforcepsgraspersneedle-fda-510k.jpg K933067 - PROBES,SCISSORS,FORCEPS,GRASPERS,&NEEDLE HOLDERS K933067 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medline Industries, Inc.. Cleared Jan 1994. https://www.510kdatabase.net/k935181/ 1994-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k935181-aspartate-aminotransferase-ast-test-fda-510k.jpg K935181 - ASPARTATE AMINOTRANSFERASE (AST) TEST K935181 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jan 1994. https://www.510kdatabase.net/k924608/ 1994-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k924608-hydrogel-coated-percuflexr-drainage-fda-510k.jpg K924608 - HYDROGEL COATED PERCUFLEX(R) DRAINAGE CATHETERS K924608 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Jan 1994. https://www.510kdatabase.net/k926303/ 1994-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k926303-arthrex-instruments-wrist-fda-510k.jpg K926303 - ARTHREX INSTRUMENTS (WRIST) K926303 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jan 1994. https://www.510kdatabase.net/k933334/ 1994-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k933334-magic-torque-guidewire-fda-510k.jpg K933334 - MAGIC TORQUE GUIDEWIRE K933334 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Jan 1994. https://www.510kdatabase.net/k933590/ 1994-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k933590-baxter-reinforced-expanded-ptfe-fda-510k.jpg K933590 - BAXTER REINFORCED EXPANDED PTFE VASCULAR GRAFT K933590 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jan 1994. https://www.510kdatabase.net/k935041/ 1994-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k935041-3m-temporary-crown-bridge-material-fda-510k.jpg K935041 - 3M TEMPORARY CROWN & BRIDGE MATERIAL K935041 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Jan 1994. https://www.510kdatabase.net/k935082/ 1994-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k935082-3m-dental-electronic-anesthesia-dea-fda-510k.jpg K935082 - 3M DENTAL ELECTRONIC ANESTHESIA (DEA) SYSTEM 8670 MODIFICATION K935082 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Jan 1994. https://www.510kdatabase.net/k935085/ 1994-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k935085-3m-dental-electrononic-anesthesia-dea0-fda-510k.jpg K935085 - 3M DENTAL ELECTRONONIC ANESTHESIA (DEA0 SYSTEM 8670 ADDITIONAL APPLICATIONS K935085 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Jan 1994. https://www.510kdatabase.net/k935507/ 1994-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k935507-argedent-77pf-fda-510k.jpg K935507 - ARGEDENT 77PF K935507 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jan 1994. https://www.510kdatabase.net/k935508/ 1994-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k935508-argedent-78pf-fda-510k.jpg K935508 - ARGEDENT 78PF K935508 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jan 1994. https://www.510kdatabase.net/k935736/ 1994-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k935736-charisma-superlight-fda-510k.jpg K935736 - CHARISMA SUPERLIGHT K935736 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Jan 1994. https://www.510kdatabase.net/k935829/ 1994-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k935829-argeloy-partial-non-precious-fda-510k.jpg K935829 - ARGELOY PARTIAL (NON-PRECIOUS) K935829 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jan 1994. https://www.510kdatabase.net/k935972/ 1994-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k935972-argeloy-np-v-non-precious-dental-alloy-fda-510k.jpg K935972 - ARGELOY N.P. (V) (NON-PRECIOUS DENTAL ALLOY FOR PROCELAIN APPLICATION) K935972 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jan 1994. https://www.510kdatabase.net/k932699/ 1994-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k932699-arthrex-ar-8200-shaver-system-fda-510k.jpg K932699 - ARTHREX AR-8200 SHAVER SYSTEM K932699 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Jan 1994. https://www.510kdatabase.net/k933725/ 1994-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k933725-endoscopic-needle-driver-fda-510k.jpg K933725 - ENDOSCOPIC NEEDLE DRIVER K933725 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Jan 1994. https://www.510kdatabase.net/k935042/ 1994-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k935042-roche-abuscreen-sample-oxidizing-reagent-fda-510k.jpg K935042 - ROCHE ABUSCREEN SAMPLE OXIDIZING REAGENT K935042 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jan 1994. https://www.510kdatabase.net/k935070/ 1994-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k935070-grasping-forceps-biopsy-forceps-spoon-fda-510k.jpg K935070 - GRASPING FORCEPS, BIOPSY FORCEPS, SPOON FORCEPS K935070 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jan 1994. https://www.510kdatabase.net/k932605/ 1994-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k932605-cobas-r-core-t4-eia-fda-510k.jpg K932605 - COBAS (R) CORE T4 EIA K932605 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jan 1994. https://www.510kdatabase.net/k932607/ 1994-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k932607-cobasr-core-ft4-eia-fda-510k.jpg K932607 - COBAS(R) CORE FT4 EIA K932607 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jan 1994. https://www.510kdatabase.net/k934742/ 1994-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k934742-swan-ganz-continuous-cardiac-fda-510k.jpg K934742 - SWAN-GANZ CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VENOUS PORT K934742 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jan 1994. https://www.510kdatabase.net/k925072/ 1994-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k925072-amk-landmark-revision-knee-system-fda-510k.jpg K925072 - AMK LANDMARK REVISION KNEE SYSTEM K925072 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jan 1994. https://www.510kdatabase.net/k931298/ 1994-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k931298-signa-advantage-1ot-magnetic-resonance-fda-510k.jpg K931298 - SIGNA ADVANTAGE 1.OT MAGNETIC RESONANCE SYSTEM K931298 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jan 1994. https://www.510kdatabase.net/k935180/ 1994-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k935180-alanine-aminotransferase-alt-test-fda-510k.jpg K935180 - ALANINE AMINOTRANSFERASE (ALT) TEST K935180 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jan 1994. https://www.510kdatabase.net/k933078/ 1994-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k933078-beckman-alpha-1-microglobulin-a1m-fda-510k.jpg K933078 - BECKMAN ALPHA-1-MICROGLOBULIN (A1M) REAGENT K933078 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jan 1994. https://www.510kdatabase.net/k934730/ 1994-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k934730-karl-storz-endoscopic-cold-knife-blades-fda-510k.jpg K934730 - KARL STORZ ENDOSCOPIC COLD KNIFE BLADES K934730 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jan 1994. https://www.510kdatabase.net/k935138/ 1994-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k935138-immulite-progesterone-fda-510k.jpg K935138 - IMMULITE PROGESTERONE K935138 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jan 1994. https://www.510kdatabase.net/k931936/ 1994-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k931936-gianturco-helfrich-hernis-mesh-fda-510k.jpg K931936 - GIANTURCO-HELFRICH HERNIS MESH K931936 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cook, Inc.. Cleared Jan 1994. https://www.510kdatabase.net/k932926/ 1994-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k932926-immulite-estradiol-fda-510k.jpg K932926 - IMMULITE ESTRADIOL K932926 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jan 1994. https://www.510kdatabase.net/k915612/ 1994-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k915612-argenco-y-fda-510k.jpg K915612 - ARGENCO Y + K915612 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jan 1994. https://www.510kdatabase.net/k925837/ 1994-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k925837-amk-landmark-revision-knee-full-wedge-fda-510k.jpg K925837 - AMK LANDMARK REVISION KNEE FULL WEDGE TIBIAL TRAY K925837 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jan 1994. https://www.510kdatabase.net/k930772/ 1994-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k930772-ethicon-monocryl-poliglecaprone-25-fda-510k.jpg K930772 - ETHICON* MONOCRYL (POLIGLECAPRONE 25) SUTURE K930772 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Jan 1994. https://www.510kdatabase.net/k931271/ 1994-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k931271-ethi-pack-surgical-stainless-steel-fda-510k.jpg K931271 - ETHI-PACK* SURGICAL STAINLESS STEEL SUTURE K931271 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Jan 1994. https://www.510kdatabase.net/k932271/ 1994-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k932271-magnetic-reson-diag-device-magnetom-fda-510k.jpg K932271 - MAGNETIC RESON DIAG DEVICE MAGNETOM PROJECT 016 K932271 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 1994. https://www.510kdatabase.net/k932346/ 1994-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k932346-aesculap-manual-endoscopic-instruments-fda-510k.jpg K932346 - AESCULAP MANUAL ENDOSCOPIC INSTRUMENTS K932346 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Jan 1994. https://www.510kdatabase.net/k933235/ 1994-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k933235-cordis-bipal-7-biopsy-bipal-biopsy-fda-510k.jpg K933235 - CORDIS BIPAL 7 /BIOPSY & BIPAL BIOPSY FORCEPS, MODIF K933235 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Jan 1994. https://www.510kdatabase.net/k934746/ 1994-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k934746-3m-curing-light-xl1500-fda-510k.jpg K934746 - 3M CURING LIGHT XL1500 K934746 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Jan 1994. https://www.510kdatabase.net/k935117/ 1994-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k935117-emitr-iic-opiate-assay-fda-510k.jpg K935117 - EMIT(R) IIC OPIATE ASSAY K935117 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jan 1994. https://www.510kdatabase.net/k925025/ 1994-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k925025-prism-bone-cement-mixing-system-fda-510k.jpg K925025 - PRISM BONE CEMENT MIXING SYSTEM K925025 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jan 1994. https://www.510kdatabase.net/k933139/ 1994-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k933139-3m-vitremer-luting-cement-fda-510k.jpg K933139 - 3M VITREMER LUTING CEMENT K933139 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Jan 1994. https://www.510kdatabase.net/k934386/ 1994-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k934386-impax-5000-fda-510k.jpg K934386 - IMPAX 5000 K934386 is a FDA 510(k) cleared radiology medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Jan 1994. https://www.510kdatabase.net/k933020/ 1994-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k933020-mod-phantom-5-plus-urol-balloon-fda-510k.jpg K933020 - MOD. PHANTOM 5 PLUS UROL. BALLOON DILATION CATHETER K933020 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Jan 1994. https://www.510kdatabase.net/k933696/ 1994-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k933696-sigma-electrolyte-reference-reagent-fda-510k.jpg K933696 - SIGMA ELECTROLYTE REFERENCE REAGENT K933696 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Jan 1994. https://www.510kdatabase.net/k935064/ 1994-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k935064-endopath-endoscopic-linear-cutter-fda-510k.jpg K935064 - ENDOPATH ENDOSCOPIC LINEAR CUTTER MODIFICATION K935064 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Ethicon, Inc.. Cleared Jan 1994. https://www.510kdatabase.net/k935230/ 1994-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k935230-emit-iic-negative-control-control-i-fda-510k.jpg K935230 - EMIT IIC NEGATIVE CONTROL, CONTROL I AND II K935230 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jan 1994. https://www.510kdatabase.net/k935550/ 1994-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k935550-abuscreen-online-negative-calcontrol-fda-510k.jpg K935550 - ABUSCREEN ONLINE NEGATIVE CAL/CONTROL CAL PACK AND MIL CALIBRATION PACK K935550 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jan 1994. https://www.510kdatabase.net/k934428/ 1993-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k934428-argyle-turkel-safety-pneumothorax-fda-510k.jpg K934428 - ARGYLE TURKEL SAFETY PNEUMOTHORAX PROCEDURE TRAY K934428 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sherwood Medical Co.. Cleared Dec 1993. https://www.510kdatabase.net/k932548/ 1993-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k932548-abuscreen-online-low-cutoff-calibrators-fda-510k.jpg K932548 - ABUSCREEN ONLINE LOW-CUTOFF CALIBRATORS K932548 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Dec 1993. https://www.510kdatabase.net/k933236/ 1993-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k933236-cordis-opta-5tm-modification-fda-510k.jpg K933236 - CORDIS OPTA 5(TM), MODIFICATION K933236 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Dec 1993. https://www.510kdatabase.net/k934499/ 1993-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k934499-magnetic-resonance-diagnostic-accessory-fda-510k.jpg K934499 - MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY K934499 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Dec 1993. https://www.510kdatabase.net/k934724/ 1993-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k934724-aesculap-trocar-instrument-set-fda-510k.jpg K934724 - AESCULAP TROCAR INSTRUMENT SET K934724 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Dec 1993. https://www.510kdatabase.net/k933992/ 1993-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k933992-olympus-sclerotherapy-balloon-fda-510k.jpg K933992 - OLYMPUS SCLEROTHERAPY BALLOON K933992 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Corp.. Cleared Dec 1993. https://www.510kdatabase.net/k934053/ 1993-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k934053-quanta-litetm-histone-elisa-fda-510k.jpg K934053 - QUANTA LITE(TM) HISTONE ELISA K934053 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Dec 1993. https://www.510kdatabase.net/k933834/ 1993-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k933834-aesculap-rigid-endoscopes-fda-510k.jpg K933834 - AESCULAP RIGID ENDOSCOPES K933834 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Dec 1993. https://www.510kdatabase.net/k930360/ 1993-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k930360-sutures-fda-510k.jpg K930360 - SUTURES K930360 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Dec 1993. https://www.510kdatabase.net/k933679/ 1993-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k933679-sigma-bun-reagent-fda-510k.jpg K933679 - SIGMA BUN REAGENT K933679 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Dec 1993. https://www.510kdatabase.net/k933691/ 1993-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k933691-sigma-co2-alkaline-buffer-reagent-fda-510k.jpg K933691 - SIGMA CO2 ALKALINE BUFFER REAGENT K933691 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Dec 1993. https://www.510kdatabase.net/k934803/ 1993-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k934803-arterial-venous-blood-tubing-sets-for-fda-510k.jpg K934803 - ARTERIAL & VENOUS BLOOD TUBING SETS FOR HEMODIALYSIS K934803 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Dec 1993. https://www.510kdatabase.net/k935178/ 1993-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k935178-emds-phosphorous-phos-test-fda-510k.jpg K935178 - EMDS PHOSPHOROUS (PHOS) TEST K935178 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Dec 1993. https://www.510kdatabase.net/k935179/ 1993-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k935179-emds-albumin-alb-test-fda-510k.jpg K935179 - EMDS ALBUMIN (ALB) TEST K935179 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Dec 1993. https://www.510kdatabase.net/k935136/ 1993-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k935136-cholesterol-chol-test-item-no-65410-fda-510k.jpg K935136 - CHOLESTEROL (CHOL) TEST ITEM NO. 65410 K935136 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Dec 1993. https://www.510kdatabase.net/k935174/ 1993-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k935174-total-protein-test-tpro-fda-510k.jpg K935174 - TOTAL PROTEIN TEST (TPRO) K935174 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Dec 1993. https://www.510kdatabase.net/k935175/ 1993-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k935175-lactate-dehydrogenase-ld-fda-510k.jpg K935175 - LACTATE DEHYDROGENASE (LD) K935175 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Dec 1993. https://www.510kdatabase.net/k935176/ 1993-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k935176-iron-test-fda-510k.jpg K935176 - IRON TEST K935176 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Dec 1993. https://www.510kdatabase.net/k935177/ 1993-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k935177-gamma-glutamyl-transferase-ggt-test-fda-510k.jpg K935177 - GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST K935177 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Dec 1993. https://www.510kdatabase.net/k935095/ 1993-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k935095-8260-series-3m-programmable-hearing-fda-510k.jpg K935095 - 8260 SERIES 3M PROGRAMMABLE HEARING INSTRUMENTS K935095 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: 3M Company. Cleared Dec 1993. https://www.510kdatabase.net/k933356/ 1993-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k933356-merit-fda-510k.jpg K933356 - MERIT K933356 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Dec 1993. https://www.510kdatabase.net/k934310/ 1993-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k934310-bageasyr-iii-adult-disposable-manual-fda-510k.jpg K934310 - BAGEASY(R) III ADULT DISPOSABLE MANUAL RESUSCITATOR K934310 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Dec 1993. https://www.510kdatabase.net/k934832/ 1993-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k934832-impax-3000-fda-510k.jpg K934832 - IMPAX 3000 K934832 is a FDA 510(k) cleared radiology medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Dec 1993. https://www.510kdatabase.net/k931962/ 1993-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k931962-non-absorbable-gauze-fda-510k.jpg K931962 - NON-ABSORBABLE GAUZE K931962 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Dec 1993. https://www.510kdatabase.net/k933703/ 1993-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k933703-sigma-wash-concentrate-solution-fda-510k.jpg K933703 - SIGMA WASH CONCENTRATE SOLUTION K933703 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Dec 1993. https://www.510kdatabase.net/k933894/ 1993-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k933894-disposable-perforator-fda-510k.jpg K933894 - DISPOSABLE PERFORATOR K933894 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Dec 1993. https://www.510kdatabase.net/k934283/ 1993-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k934283-dentalon-plus-modification-fda-510k.jpg K934283 - DENTALON PLUS MODIFICATION K934283 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Dec 1993. https://www.510kdatabase.net/k934760/ 1993-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k934760-immunlite-intact-pth-fda-510k.jpg K934760 - IMMUNLITE INTACT PTH K934760 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Dec 1993. https://www.510kdatabase.net/k934768/ 1993-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k934768-argelite-81sf-fda-510k.jpg K934768 - ARGELITE 81SF+ K934768 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Dec 1993. https://www.510kdatabase.net/k934773/ 1993-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k934773-argelite-a-fda-510k.jpg K934773 - ARGELITE A K934773 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Dec 1993. https://www.510kdatabase.net/k932321/ 1993-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k932321-laparoscopy-optics-fda-510k.jpg K932321 - LAPAROSCOPY OPTICS K932321 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medline Industries, Inc.. Cleared Dec 1993. https://www.510kdatabase.net/k933692/ 1993-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k933692-sigma-co2-acid-reagent-fda-510k.jpg K933692 - SIGMA CO2 ACID REAGENT K933692 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Dec 1993. https://www.510kdatabase.net/k934191/ 1993-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k934191-new-blue-max-balloon-dilatation-catheter-fda-510k.jpg K934191 - NEW BLUE MAX BALLOON DILATATION CATHETER K934191 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Dec 1993. https://www.510kdatabase.net/k935182/ 1993-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k935182-emds-alkanine-phosphatase-alp-test-fda-510k.jpg K935182 - EMDS ALKANINE PHOSPHATASE (ALP) TEST K935182 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Dec 1993. https://www.510kdatabase.net/k935183/ 1993-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k935183-emds-magnesium-mg-test-fda-510k.jpg K935183 - EMDS MAGNESIUM (MG) TEST K935183 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Dec 1993. https://www.510kdatabase.net/k932172/ 1993-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k932172-medtronic-models-4057m4058m4557m-fda-510k.jpg K932172 - MEDTRONIC MODELS 4057M,4058M,4557M, PACING LEADS K932172 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Dec 1993. https://www.510kdatabase.net/k933943/ 1993-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k933943-fep-ringed-gore-tex-stretch-vascualr-fda-510k.jpg K933943 - FEP RINGED GORE-TEX STRETCH VASCUALR GRAFT WITH REMOVABLE RINGS K933943 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Dec 1993. https://www.510kdatabase.net/k934726/ 1993-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k934726-fep-ringed-gore-tex-vascular-graft-fda-510k.jpg K934726 - FEP RINGED GORE-TEX VASCULAR GRAFT K934726 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Dec 1993. https://www.510kdatabase.net/k934534/ 1993-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k934534-trocar-wcannula-o-ring-adapter-and-fda-510k.jpg K934534 - TROCAR W/CANNULA, O RING, ADAPTER, AND ADAPTER SLEEVE MODIFICATION K934534 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Baxter Healthcare Corp. Cleared Dec 1993. https://www.510kdatabase.net/k934898/ 1993-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k934898-glucometer-qa-blood-glucose-meter-fda-510k.jpg K934898 - GLUCOMETER QA BLOOD GLUCOSE METER MODIFICATION K934898 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Dec 1993. https://www.510kdatabase.net/k934900/ 1993-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k934900-glucometer-encore-qa-blood-glucose-fda-510k.jpg K934900 - GLUCOMETER ENCORE QA BLOOD GLUCOSE METER MODIFICATION K934900 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Dec 1993. https://www.510kdatabase.net/k931556/ 1993-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k931556-argenco-m-fda-510k.jpg K931556 - ARGENCO M K931556 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Dec 1993. https://www.510kdatabase.net/k934064/ 1993-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k934064-reflotron-hemoglobin-test-tabs-fda-510k.jpg K934064 - REFLOTRON HEMOGLOBIN TEST TABS K934064 is a FDA 510(k) cleared hematology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Dec 1993. https://www.510kdatabase.net/k930776/ 1993-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k930776-cobas-core-tsh-eia-fda-510k.jpg K930776 - COBAS CORE TSH EIA K930776 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Dec 1993. https://www.510kdatabase.net/k932608/ 1993-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k932608-cobasr-core-t3-eia-fda-510k.jpg K932608 - COBAS(R) CORE T3 EIA K932608 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Dec 1993. https://www.510kdatabase.net/k933815/ 1993-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k933815-bard-endoscopic-injection-system-fda-510k.jpg K933815 - BARD ENDOSCOPIC INJECTION SYSTEM K933815 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 1993. https://www.510kdatabase.net/k934087/ 1993-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k934087-implantable-clip-applier-fda-510k.jpg K934087 - IMPLANTABLE CLIP APPLIER K934087 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Dec 1993. https://www.510kdatabase.net/k923011/ 1993-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k923011-osteonics-unix-unicompartmental-fda-510k.jpg K923011 - OSTEONICS UNIX UNICOMPARTMENTAL K923011 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Nov 1993. https://www.510kdatabase.net/k932663/ 1993-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k932663-medline-ac-powered-healthcare-beds-fda-510k.jpg K932663 - MEDLINE A/C POWERED HEALTHCARE BEDS & ACCESSORIES K932663 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Nov 1993. https://www.510kdatabase.net/k933541/ 1993-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k933541-gore-tex-periodontal-material-titanium-fda-510k.jpg K933541 - GORE-TEX PERIODONTAL MATERIAL - TITANIUM REINFORCED CONFIGURATIONS K933541 is a FDA 510(k) cleared dental medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Nov 1993. https://www.510kdatabase.net/k934723/ 1993-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k934723-argyle-aspr-care-closed-suction-system-fda-510k.jpg K934723 - ARGYLE ASPR-CARE CLOSED SUCTION SYSTEM K934723 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sherwood Medical Co.. Cleared Nov 1993. https://www.510kdatabase.net/k926478/ 1993-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k926478-gore-tekr-soft-tissue-patch-fda-510k.jpg K926478 - GORE-TEK(R) SOFT TISSUE PATCH K926478 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Nov 1993. https://www.510kdatabase.net/k932787/ 1993-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k932787-batroxobin-reagent-fda-510k.jpg K932787 - BATROXOBIN REAGENT K932787 is a FDA 510(k) cleared hematology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Nov 1993. https://www.510kdatabase.net/k933887/ 1993-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k933887-implantable-clip-fda-510k.jpg K933887 - IMPLANTABLE CLIP K933887 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Nov 1993. https://www.510kdatabase.net/k934123/ 1993-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k934123-stopcock-one-port-manifold-fda-510k.jpg K934123 - STOPCOCK (ONE-PORT MANIFOLD) K934123 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Nov 1993. https://www.510kdatabase.net/k924977/ 1993-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k924977-codman-laser-neuroendoscope-fda-510k.jpg K924977 - CODMAN LASER NEUROENDOSCOPE K924977 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Nov 1993. https://www.510kdatabase.net/k931544/ 1993-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k931544-15t-edge-and-10t-vista-systems-fda-510k.jpg K931544 - 1.5T EDGE AND 1.0T VISTA SYSTEMS K931544 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Nov 1993. https://www.510kdatabase.net/k933715/ 1993-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k933715-boston-scientific-corporation-side-fda-510k.jpg K933715 - BOSTON SCIENTIFIC CORPORATION SIDE FIRING LASER GUIDE K933715 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Boston Scientific Corp. Cleared Nov 1993. https://www.510kdatabase.net/k933835/ 1993-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k933835-05t-asset-system-fda-510k.jpg K933835 - 0.5T ASSET SYSTEM K933835 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Nov 1993. https://www.510kdatabase.net/k934100/ 1993-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k934100-remel-cefprozil-30-mcg-susceptibility-fda-510k.jpg K934100 - REMEL CEFPROZIL 30 MCG SUSCEPTIBILITY DISK K934100 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Nov 1993. https://www.510kdatabase.net/k934769/ 1993-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k934769-argelite-w-fda-510k.jpg K934769 - ARGELITE W K934769 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Nov 1993. https://www.510kdatabase.net/k924071/ 1993-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k924071-integron-surgical-gloves-fda-510k.jpg K924071 - INTEGRON SURGICAL GLOVES K924071 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Nov 1993. https://www.510kdatabase.net/k930746/ 1993-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k930746-synthetic-absorbable-surgical-suture-fda-510k.jpg K930746 - SYNTHETIC ABSORBABLE SURGICAL SUTURE K930746 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Nov 1993. https://www.510kdatabase.net/k932778/ 1993-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k932778-boehringer-mannheim-es-300-fda-510k.jpg K932778 - BOEHRINGER MANNHEIM ES 300 AL(AUTOLOADER) ANALYZER K932778 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Nov 1993. https://www.510kdatabase.net/k925093/ 1993-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k925093-system-6300-series-high-performance-fda-510k.jpg K925093 - SYSTEM 6300 SERIES HIGH PERFORMANCE AMINO ACID ANA K925093 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Nov 1993. https://www.510kdatabase.net/k926384/ 1993-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k926384-statak-mini-statak-soft-tissue-fda-510k.jpg K926384 - STATAK & MINI-STATAK SOFT TISSUE ATTACHMENT DEVICE K926384 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Nov 1993. https://www.510kdatabase.net/k930831/ 1993-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k930831-mg-ii-porous-knee-system-femoral-fda-510k.jpg K930831 - MG II POROUS KNEE SYSTEM FEMORAL COMPONENTS K930831 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Nov 1993. https://www.510kdatabase.net/k933425/ 1993-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k933425-ammoniaethanol-controls-highlow-cat-fda-510k.jpg K933425 - AMMONIA/ETHANOL CONTROLS, HIGH/LOW, CAT.# A7937/7812 K933425 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Nov 1993. https://www.510kdatabase.net/k934361/ 1993-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k934361-olympus-creatinine-reagent-fda-510k.jpg K934361 - OLYMPUS CREATININE REAGENT K934361 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Nov 1993. https://www.510kdatabase.net/k933985/ 1993-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k933985-microwave-insurg-introducer-fda-510k.jpg K933985 - MICROWAVE INSURG INTRODUCER K933985 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Boston Scientific Corp. Cleared Nov 1993. https://www.510kdatabase.net/k924320/ 1993-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k924320-ultra-thin-balloon-dilatation-catheter-fda-510k.jpg K924320 - ULTRA THIN BALLOON DILATATION CATHETER K924320 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Nov 1993. https://www.510kdatabase.net/k926362/ 1993-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k926362-glucostix-reagent-strips-fda-510k.jpg K926362 - GLUCOSTIX REAGENT STRIPS K926362 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Nov 1993. https://www.510kdatabase.net/k930322/ 1993-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k930322-free-thyroxinef-t4-methodtechnicon-fda-510k.jpg K930322 - FREE THYROXINE(F T4) METHOD/TECHNICON IMMUNO 1(R) K930322 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Nov 1993. https://www.510kdatabase.net/k932301/ 1993-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k932301-fenwalr-40150-micron-dual-screen-filter-fda-510k.jpg K932301 - FENWAL(R) 40/150 MICRON DUAL SCREEN FILTER K932301 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Nov 1993. https://www.510kdatabase.net/k932517/ 1993-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k932517-ironuibc-reagent-fda-510k.jpg K932517 - IRON/UIBC REAGENT K932517 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Nov 1993. https://www.510kdatabase.net/k934144/ 1993-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k934144-dupont-aca-urine-methadone-calibrator-fda-510k.jpg K934144 - DUPONT ACA URINE METHADONE CALIBRATOR K934144 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Nov 1993. https://www.510kdatabase.net/k934145/ 1993-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k934145-dupont-aca-urine-methadone-control-fda-510k.jpg K934145 - DUPONT ACA URINE METHADONE CONTROL K934145 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Nov 1993. https://www.510kdatabase.net/k934147/ 1993-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k934147-dupont-aca-methadone-umeth-screen-test-fda-510k.jpg K934147 - DUPONT ACA METHADONE (UMETH) SCREEN TEST PACK K934147 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Nov 1993. https://www.510kdatabase.net/k925607/ 1993-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k925607-ha-anatomic-hip-prosth-wti-nidium-surf-fda-510k.jpg K925607 - HA ANATOMIC HIP PROSTH W/TI-NIDIUM SURF HARD PROCE K925607 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Nov 1993. https://www.510kdatabase.net/k934367/ 1993-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k934367-pc-mini-fda-510k.jpg K934367 - PC-MINI K934367 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Nov 1993. https://www.510kdatabase.net/k925351/ 1993-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k925351-synthesusa-anterior-spinal-plate-fda-510k.jpg K925351 - SYNTHES(U.S.A.) ANTERIOR SPINAL PLATE K925351 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Nov 1993. https://www.510kdatabase.net/k932467/ 1993-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k932467-ilab-9001800-clinical-chemistry-system-fda-510k.jpg K932467 - ILAB 900/1800 CLINICAL CHEMISTRY SYSTEM K932467 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Nov 1993. https://www.510kdatabase.net/k934136/ 1993-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k934136-olympus-chloride-reagent-modification-fda-510k.jpg K934136 - OLYMPUS CHLORIDE REAGENT, MODIFICATION K934136 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Nov 1993. https://www.510kdatabase.net/k923611/ 1993-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k923611-ultra-thin-balloon-dilatation-catheter-fda-510k.jpg K923611 - ULTRA THIN BALLOON DILATATION CATHETER K923611 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Nov 1993. https://www.510kdatabase.net/k933110/ 1993-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k933110-olympus-guide-wire-fda-510k.jpg K933110 - OLYMPUS GUIDE WIRE K933110 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Corp.. Cleared Nov 1993. https://www.510kdatabase.net/k925418/ 1993-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k925418-energized-container-system-fda-510k.jpg K925418 - ENERGIZED CONTAINER SYSTEM K925418 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1993. https://www.510kdatabase.net/k933409/ 1993-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k933409-impax-1000-fda-510k.jpg K933409 - IMPAX 1000 K933409 is a FDA 510(k) cleared radiology medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Nov 1993. https://www.510kdatabase.net/k933589/ 1993-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k933589-boehringer-mannheim-tina-quant-fda-510k.jpg K933589 - BOEHRINGER MANNHEIM TINA-QUANT TRANSFERRIN ASSAY K933589 is a FDA 510(k) cleared immunology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Nov 1993. https://www.510kdatabase.net/k933700/ 1993-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k933700-dye-management-system-fda-510k.jpg K933700 - DYE MANAGEMENT SYSTEM K933700 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1993. https://www.510kdatabase.net/k931743/ 1993-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k931743-burron-cardiovascular-angestattm-fda-510k.jpg K931743 - BURRON CARDIOVASCULAR ANGESTAT(TM) K931743 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Nov 1993. https://www.510kdatabase.net/k933717/ 1993-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k933717-olympus-measuring-devices-fda-510k.jpg K933717 - OLYMPUS MEASURING DEVICES K933717 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Corp.. Cleared Nov 1993. https://www.510kdatabase.net/k924452/ 1993-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k924452-swan-ganz-ccosvo2-thermodilution-fda-510k.jpg K924452 - SWAN-GANZ CCO/SVO2 THERMODILUTION CATHETER K924452 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Oct 1993. https://www.510kdatabase.net/k931150/ 1993-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k931150-gore-tex-micro-mesh-fda-510k.jpg K931150 - GORE-TEX MICRO MESH K931150 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Oct 1993. https://www.510kdatabase.net/k932442/ 1993-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k932442-cardio-rep-recombinant-ck-abnormal-fda-510k.jpg K932442 - CARDIO REP RECOMBINANT CK ABNORMAL CONTROL K932442 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Oct 1993. https://www.510kdatabase.net/k933514/ 1993-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k933514-bacticard-strep-fda-510k.jpg K933514 - BACTICARD STREP K933514 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Oct 1993. https://www.510kdatabase.net/k933657/ 1993-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k933657-remel-azithromlycin-15-mcg-fda-510k.jpg K933657 - REMEL AZITHROMLYCIN 15 MCG SUSCEPTIBILITY DISK K933657 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Oct 1993. https://www.510kdatabase.net/k921113/ 1993-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k921113-exatech-mcs-porous-coated-total-hip-fda-510k.jpg K921113 - EXATECH MCS POROUS COATED TOTAL HIP FEMORAL STEM K921113 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Oct 1993. https://www.510kdatabase.net/k921114/ 1993-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k921114-exactech-mcs-porous-coated-total-hip-fda-510k.jpg K921114 - EXACTECH MCS POROUS COATED TOTAL HIP ACETABULAR K921114 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Oct 1993. https://www.510kdatabase.net/k933204/ 1993-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k933204-bard-ptfe-vascular-graft-fda-510k.jpg K933204 - BARD PTFE VASCULAR GRAFT K933204 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 1993. https://www.510kdatabase.net/k932011/ 1993-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k932011-pathromtin-fda-510k.jpg K932011 - PATHROMTIN K932011 is a FDA 510(k) cleared hematology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Oct 1993. https://www.510kdatabase.net/k932188/ 1993-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k932188-safeset-reservoir-fda-510k.jpg K932188 - SAFESET RESERVOIR K932188 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1993. https://www.510kdatabase.net/k932344/ 1993-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k932344-magnetic-resonance-diagnostic-device-fda-510k.jpg K932344 - MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES K932344 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 1993. https://www.510kdatabase.net/k926299/ 1993-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k926299-contour-femoral-hip-stem-whydroapatite-fda-510k.jpg K926299 - CONTOUR FEMORAL HIP STEM W/HYDROAPATITE COATING K926299 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Oct 1993. https://www.510kdatabase.net/k930950/ 1993-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k930950-gore-tex-cardiovascular-patch-surgical-fda-510k.jpg K930950 - GORE-TEX CARDIOVASCULAR PATCH & SURGICAL MEMBRANE K930950 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Oct 1993. https://www.510kdatabase.net/k933695/ 1993-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k933695-sigma-electrolyte-buffer-fda-510k.jpg K933695 - SIGMA ELECTROLYTE BUFFER K933695 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Oct 1993. https://www.510kdatabase.net/k934121/ 1993-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k934121-vista-folate-assay-fda-510k.jpg K934121 - VISTA FOLATE ASSAY K934121 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Oct 1993. https://www.510kdatabase.net/k934357/ 1993-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k934357-liquichek-routine-urime-chemistry-fda-510k.jpg K934357 - LIQUICHEK ROUTINE URIME CHEMISTRY CONTROL, LEVELS 1 & 2 K934357 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Oct 1993. https://www.510kdatabase.net/k925638/ 1993-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k925638-phoenix-disposable-pressure-transducer-fda-510k.jpg K925638 - PHOENIX DISPOSABLE PRESSURE TRANSDUCER #73-600 K925638 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Oct 1993. https://www.510kdatabase.net/k931019/ 1993-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k931019-becton-dickinson-locking-safety-gardtm-fda-510k.jpg K931019 - BECTON DICKINSON LOCKING SAFETY-GARD(TM) IV NEEDLE K931019 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1993. https://www.510kdatabase.net/k931301/ 1993-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k931301-olympus-amylase-reagent-fda-510k.jpg K931301 - OLYMPUS AMYLASE REAGENT K931301 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Oct 1993. https://www.510kdatabase.net/k931464/ 1993-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k931464-baxter-coronary-angioscope-inflation-fda-510k.jpg K931464 - BAXTER CORONARY ANGIOSCOPE INFLATION DEVICE K931464 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Oct 1993. https://www.510kdatabase.net/k932768/ 1993-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k932768-cardio-rep-ck-calibrators-1-2-cat-no-fda-510k.jpg K932768 - CARDIO REP CK CALIBRATORS 1 & 2 CAT. NO. 3322 & 3323 K932768 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Oct 1993. https://www.510kdatabase.net/k932980/ 1993-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k932980-total-t4-fpia-reagent-setcalibrator-t-fda-510k.jpg K932980 - TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116 K932980 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Oct 1993. https://www.510kdatabase.net/k933697/ 1993-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k933697-sigma-cre-reagent-fda-510k.jpg K933697 - SIGMA CRE REAGENT K933697 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Oct 1993. https://www.510kdatabase.net/k922159/ 1993-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k922159-infinity-porous-coated-trochanteric-fda-510k.jpg K922159 - INFINITY POROUS-COATED TROCHANTERIC MODULE K922159 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Wrightmedicaltechnologyinc. Cleared Oct 1993. https://www.510kdatabase.net/k933496/ 1993-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k933496-maxima-filtered-hardshell-reservior-fda-510k.jpg K933496 - MAXIMA FILTERED HARDSHELL RESERVIOR K933496 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Oct 1993. https://www.510kdatabase.net/k934042/ 1993-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k934042-chemstrip-super-ua-urine-analyzer-fda-510k.jpg K934042 - CHEMSTRIP SUPER UA URINE ANALYZER K934042 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Oct 1993. https://www.510kdatabase.net/k934045/ 1993-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k934045-beckman-hdl-cholesterol-reagent-fda-510k.jpg K934045 - BECKMAN HDL CHOLESTEROL REAGENT K934045 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Oct 1993. https://www.510kdatabase.net/k933693/ 1993-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k933693-sigma-cx-3-calibration-standard-level-2-fda-510k.jpg K933693 - SIGMA CX-3 CALIBRATION STANDARD LEVEL 2 K933693 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Oct 1993. https://www.510kdatabase.net/k933955/ 1993-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k933955-dupont-standard-c-for-the-dimension-fda-510k.jpg K933955 - DUPONT STANDARD C FOR THE DIMENSION CLINICAL CHEMISTRY SYSTEM K933955 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Oct 1993. https://www.510kdatabase.net/k921977/ 1993-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k921977-synergy-screen-test-modification-fda-510k.jpg K921977 - SYNERGY SCREEN TEST, MODIFICATION K921977 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Oct 1993. https://www.510kdatabase.net/k922608/ 1993-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k922608-endopath-ep-disposable-trocar-fda-510k.jpg K922608 - ENDOPATH EP DISPOSABLE TROCAR K922608 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Oct 1993. https://www.510kdatabase.net/k926453/ 1993-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k926453-synthes-usa-anterior-cervical-fda-510k.jpg K926453 - SYNTHES (U.S.A.) ANTERIOR CERVICAL VERTEBRAE PLATE K926453 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Oct 1993. https://www.510kdatabase.net/k931402/ 1993-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k931402-il-test-glucose-fda-510k.jpg K931402 - IL TEST GLUCOSE K931402 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Oct 1993. https://www.510kdatabase.net/k932887/ 1993-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k932887-access-folate-assay-fda-510k.jpg K932887 - ACCESS FOLATE ASSAY K932887 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Coulter, Inc.. Cleared Oct 1993. https://www.510kdatabase.net/k933386/ 1993-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k933386-vacutainer-brand-safety-gard-needle-fda-510k.jpg K933386 - VACUTAINER BRAND SAFETY-GARD NEEDLE HOLDER & NEEDLE DISPOSABLE CONTAINER SYSTEM K933386 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1993. https://www.510kdatabase.net/k924996/ 1993-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k924996-flexiflo-60-nasojejunal-feeding-tube-fda-510k.jpg K924996 - FLEXIFLO 60 NASOJEJUNAL FEEDING TUBE K924996 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1993. https://www.510kdatabase.net/k933702/ 1993-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k933702-sigma-cx-3-calibration-standard-level-1-fda-510k.jpg K933702 - SIGMA CX-3 CALIBRATION STANDARD LEVEL 1 K933702 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Oct 1993. https://www.510kdatabase.net/k926272/ 1993-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k926272-beckman-transferrin-kit-fda-510k.jpg K926272 - BECKMAN TRANSFERRIN KIT K926272 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Oct 1993. https://www.510kdatabase.net/k931154/ 1993-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k931154-evis-200-system-fda-510k.jpg K931154 - EVIS 200 SYSTEM K931154 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Olympus Corp.. Cleared Oct 1993. https://www.510kdatabase.net/k932693/ 1993-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k932693-edge-system-fda-510k.jpg K932693 - EDGE SYSTEM K932693 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Oct 1993. https://www.510kdatabase.net/k925106/ 1993-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k925106-implantable-pulse-generators-fda-510k.jpg K925106 - IMPLANTABLE PULSE GENERATORS K925106 is a FDA 510(k) cleared dental medical device. Manufacturer: Medtronic Vascular. Cleared Oct 1993. https://www.510kdatabase.net/k933252/ 1993-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k933252-il-test-tm-pt-fibrinogen-hs-plus-fda-510k.jpg K933252 - IL TEST (TM) PT-FIBRINOGEN HS PLUS K933252 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Oct 1993. https://www.510kdatabase.net/k915599/ 1993-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k915599-cap-washer-assembly-fda-510k.jpg K915599 - CAP WASHER ASSEMBLY K915599 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Oct 1993. https://www.510kdatabase.net/k931350/ 1993-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k931350-il-test-uric-acid-fda-510k.jpg K931350 - IL TEST URIC ACID K931350 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Oct 1993. https://www.510kdatabase.net/k932716/ 1993-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k932716-emitr-thc-50100-ng-assay-fda-510k.jpg K932716 - EMIT(R) THC 50/100 NG ASSAY K932716 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Oct 1993. https://www.510kdatabase.net/k933466/ 1993-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k933466-usci-mach-10-guide-wire-with-propel-fda-510k.jpg K933466 - USCI MACH 10 GUIDE WIRE WITH PRO/PEL COATING K933466 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 1993. https://www.510kdatabase.net/k933571/ 1993-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k933571-radias-folate-enzyme-immunoassay-fda-510k.jpg K933571 - RADIAS FOLATE ENZYME IMMUNOASSAY K933571 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Oct 1993. https://www.510kdatabase.net/k933684/ 1993-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k933684-il-test-carbamazephine-fda-510k.jpg K933684 - IL TEST CARBAMAZEPHINE K933684 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Oct 1993. https://www.510kdatabase.net/k926090/ 1993-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k926090-syva-microtrakr-ii-chlamydia-eia-block-fda-510k.jpg K926090 - SYVA MICROTRAK(R) II CHLAMYDIA EIA BLOCK REAGENT K926090 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Syva Co.. Cleared Sep 1993. https://www.510kdatabase.net/k932785/ 1993-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k932785-monojectr-monolettor-safety-lancet-fda-510k.jpg K932785 - MONOJECT(R) MONOLETTOR SAFETY LANCET K932785 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sherwood Medical Co.. Cleared Sep 1993. https://www.510kdatabase.net/k932885/ 1993-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k932885-auto-suture-endoscopic-instrument-clamp-fda-510k.jpg K932885 - AUTO SUTURE ENDOSCOPIC INSTRUMENT CLAMP K932885 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Sep 1993. https://www.510kdatabase.net/k931368/ 1993-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k931368-microtainer-brand-tube-with-edta-fda-510k.jpg K931368 - MICROTAINER BRAND TUBE WITH EDTA K931368 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1993. https://www.510kdatabase.net/k932408/ 1993-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k932408-ambulatory-infusion-pump-system-and-fda-510k.jpg K932408 - AMBULATORY INFUSION PUMP SYSTEM AND SOLUTION SETS K932408 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Sep 1993. https://www.510kdatabase.net/k933001/ 1993-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k933001-kodak-xml-300-darkroom-film-feeder-fda-510k.jpg K933001 - KODAK XML 300 DARKROOM FILM FEEDER K933001 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Sep 1993. https://www.510kdatabase.net/k933019/ 1993-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k933019-usci-super-6-6f-ptca-guiding-catheter-fda-510k.jpg K933019 - USCI SUPER 6 6F PTCA GUIDING CATHETER K933019 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Sep 1993. https://www.510kdatabase.net/k932158/ 1993-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k932158-calcium-test-item-number-65409-fda-510k.jpg K932158 - CALCIUM TEST ITEM NUMBER 65409 K932158 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Sep 1993. https://www.510kdatabase.net/k932162/ 1993-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k932162-uric-acid-test-item-number-65422-fda-510k.jpg K932162 - URIC ACID TEST ITEM NUMBER 65422 K932162 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Sep 1993. https://www.510kdatabase.net/k921956/ 1993-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k921956-hewlett-packard-model-m1353a-fetal-fda-510k.jpg K921956 - HEWLETT PACKARD MODEL M1353A FETAL MONITOR K921956 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Sep 1993. https://www.510kdatabase.net/k921957/ 1993-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k921957-hewlett-packard-model-m1351a-fetal-fda-510k.jpg K921957 - HEWLETT-PACKARD MODEL M1351A FETAL MONITOR K921957 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Sep 1993. https://www.510kdatabase.net/k930928/ 1993-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k930928-roche-abuscreen-online-for-methadone-fda-510k.jpg K930928 - ROCHE ABUSCREEN ONLINE FOR METHADONE K930928 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Sep 1993. https://www.510kdatabase.net/k931702/ 1993-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k931702-immulite-beta-2-microglobulin-fda-510k.jpg K931702 - IMMULITE BETA-2-MICROGLOBULIN K931702 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Sep 1993. https://www.510kdatabase.net/k933744/ 1993-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k933744-sastm-hcg-urine-controls-various-sizes-fda-510k.jpg K933744 - SAS(TM) HCG URINE CONTROLS, VARIOUS SIZES K933744 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sa Scientific, Inc.. Cleared Sep 1993. https://www.510kdatabase.net/k931411/ 1993-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k931411-medtronic-model-408145814582-target-fda-510k.jpg K931411 - MEDTRONIC MODEL 4081,4581,4582 TARGET TIP PACING L K931411 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Sep 1993. https://www.510kdatabase.net/k924714/ 1993-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k924714-bard-urodynamic-catheter-fda-510k.jpg K924714 - BARD URODYNAMIC CATHETER K924714 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Sep 1993. https://www.510kdatabase.net/k930304/ 1993-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k930304-cobas-core-fsh-eia-fda-510k.jpg K930304 - COBAS CORE FSH EIA K930304 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Sep 1993. https://www.510kdatabase.net/k931441/ 1993-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k931441-fenwal-40-micron-transfusion-filter-fda-510k.jpg K931441 - FENWAL 40 MICRON TRANSFUSION FILTER K931441 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Sep 1993. https://www.510kdatabase.net/k931939/ 1993-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k931939-olympus-creatinine-reagent-fda-510k.jpg K931939 - OLYMPUS CREATININE REAGENT K931939 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Sep 1993. https://www.510kdatabase.net/k932159/ 1993-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k932159-systemate-direct-bilirubin-cat-no-65406-fda-510k.jpg K932159 - SYSTEMATE DIRECT BILIRUBIN CAT. NO. 65406 K932159 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Sep 1993. https://www.510kdatabase.net/k933754/ 1993-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k933754-chenoweth-frank-radiopathological-grid-fda-510k.jpg K933754 - CHENOWETH-FRANK RADIOPATHOLOGICAL GRID K933754 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cook, Inc.. Cleared Sep 1993. https://www.510kdatabase.net/k932528/ 1993-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k932528-olympus-chlorid-reagent-modified-fda-510k.jpg K932528 - OLYMPUS CHLORID REAGENT, MODIFIED K932528 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Sep 1993. https://www.510kdatabase.net/k925591/ 1993-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k925591-meridian-medical-systems-hyper-fda-510k.jpg K925591 - MERIDIAN MEDICAL SYSTEMS HYPER INFLATION BAY SYST K925591 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Sep 1993. https://www.510kdatabase.net/k933052/ 1993-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k933052-abuscreen-onliner-for-amphetamines-fda-510k.jpg K933052 - ABUSCREEN ONLINE(R) FOR AMPHETAMINES, MODIFIED K933052 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Sep 1993. https://www.510kdatabase.net/k925587/ 1993-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k925587-nasaloral-mask-fda-510k.jpg K925587 - NASAL/ORAL MASK K925587 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Sep 1993. https://www.510kdatabase.net/k933104/ 1993-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k933104-one-handed-endopouch-specimen-fda-510k.jpg K933104 - ONE-HANDED ENDOPOUCH SPECIMEN RETRIEVAL BAG K933104 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Sep 1993. https://www.510kdatabase.net/k933201/ 1993-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k933201-aesculap-trocar-instrument-set-fda-510k.jpg K933201 - AESCULAP TROCAR INSTRUMENT SET K933201 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Aesculap, Inc.. Cleared Sep 1993. https://www.510kdatabase.net/k933076/ 1993-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k933076-aesculap-manual-endoscopic-instruments-fda-510k.jpg K933076 - AESCULAP MANUAL ENDOSCOPIC INSTRUMENTS K933076 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Sep 1993. https://www.510kdatabase.net/k926565/ 1993-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k926565-gore-textm-dual-mesh-fda-510k.jpg K926565 - GORE-TEX(TM) DUAL MESH K926565 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Sep 1993. https://www.510kdatabase.net/k933216/ 1993-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k933216-karl-storz-endoscopy-america-inc-fda-510k.jpg K933216 - KARL STORZ ENDOSCOPY-AMERICA, INC. K933216 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Sep 1993. https://www.510kdatabase.net/k933980/ 1993-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k933980-hp-m1465a-standard-airway-adapter-fda-510k.jpg K933980 - HP M1465A STANDARD AIRWAY ADAPTER K933980 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Sep 1993. https://www.510kdatabase.net/k926360/ 1993-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k926360-glucofilm-test-strips-fda-510k.jpg K926360 - GLUCOFILM TEST STRIPS K926360 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Sep 1993. https://www.510kdatabase.net/k930979/ 1993-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k930979-accu-chek-advantage-blood-glucose-system-fda-510k.jpg K930979 - ACCU-CHEK ADVANTAGE BLOOD GLUCOSE SYSTEM K930979 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Sep 1993. https://www.510kdatabase.net/k931835/ 1993-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k931835-olympus-reply-inorganic-phosphorous-fda-510k.jpg K931835 - OLYMPUS REPLY INORGANIC PHOSPHOROUS REAGENT K931835 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Sep 1993. https://www.510kdatabase.net/k932161/ 1993-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k932161-urea-nitrogen-test-item-number-65408-fda-510k.jpg K932161 - UREA NITROGEN TEST ITEM NUMBER 65408 K932161 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Sep 1993. https://www.510kdatabase.net/k933314/ 1993-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k933314-radias-ferritin-enzyme-immunoassay-fda-510k.jpg K933314 - RADIAS FERRITIN ENZYME IMMUNOASSAY K933314 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Sep 1993. https://www.510kdatabase.net/k930635/ 1993-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k930635-multistar-d-angiographic-x-ray-system-fda-510k.jpg K930635 - MULTISTAR D ANGIOGRAPHIC X-RAY SYSTEM K930635 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 1993. https://www.510kdatabase.net/k930811/ 1993-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k930811-modified-body-helmholtz-coil-fda-510k.jpg K930811 - MODIFIED BODY HELMHOLTZ COIL K930811 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 1993. https://www.510kdatabase.net/k931930/ 1993-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k931930-poydoros-lx-fda-510k.jpg K931930 - POYDOROS LX K931930 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 1993. https://www.510kdatabase.net/k932374/ 1993-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k932374-mag-reson-diag-devi-access-cir-polarcp-fda-510k.jpg K932374 - MAG RESON DIAG DEVI ACCESS CIR POLAR(CP) HEAD COIL K932374 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 1993. https://www.510kdatabase.net/k932375/ 1993-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k932375-mag-res-diag-dev-access-cir-polcp-fda-510k.jpg K932375 - MAG RES DIAG DEV ACCESS CIR POL(CP) BODY/SPINE COI K932375 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 1993. https://www.510kdatabase.net/k932445/ 1993-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k932445-sireskop-cx-fda-510k.jpg K932445 - SIRESKOP CX K932445 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 1993. https://www.510kdatabase.net/k933240/ 1993-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k933240-polydoros-is-fda-510k.jpg K933240 - POLYDOROS IS K933240 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 1993. https://www.510kdatabase.net/k924163/ 1993-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k924163-explorer360-polaris-lejackman-coron-fda-510k.jpg K924163 - EXPLORER/360-POLARIS-L.E./JACKMAN CORON SINUS ELEC K924163 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Sep 1993. https://www.510kdatabase.net/k930348/ 1993-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k930348-combo-cath-wire-guided-cytology-system-fda-510k.jpg K930348 - COMBO CATH WIRE-GUIDED CYTOLOGY SYSTEM K930348 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Sep 1993. https://www.510kdatabase.net/k922799/ 1993-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k922799-capiox-sx-hollow-fiber-oxygenator-fda-510k.jpg K922799 - CAPIOX SX HOLLOW FIBER OXYGENATOR K922799 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Sep 1993. https://www.510kdatabase.net/k930850/ 1993-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k930850-beckman-vigil-plus-control-fda-510k.jpg K930850 - BECKMAN VIGIL PLUS CONTROL K930850 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Sep 1993. https://www.510kdatabase.net/k931375/ 1993-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k931375-abbott-plum-xl-infusion-pump-fda-510k.jpg K931375 - ABBOTT PLUM XL INFUSION PUMP K931375 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1993. https://www.510kdatabase.net/k932788/ 1993-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k932788-cordis-bipal-7-biopsy-forceps-with-a-fda-510k.jpg K932788 - CORDIS BIPAL 7 BIOPSY FORCEPS WITH A INLINE HANDLE K932788 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Sep 1993. https://www.510kdatabase.net/k931744/ 1993-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k931744-olympus-reply-glucose-reagent-fda-510k.jpg K931744 - OLYMPUS REPLY GLUCOSE REAGENT K931744 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Aug 1993. https://www.510kdatabase.net/k926000/ 1993-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k926000-95-fr-sidewinder-dl-intra-aortic-fda-510k.jpg K926000 - 9.5 FR SIDEWINDER DL INTRA-AORTIC BALLON CATHETER K926000 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Aug 1993. https://www.510kdatabase.net/k932338/ 1993-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k932338-magnetom-p8-fda-510k.jpg K932338 - MAGNETOM P8 K932338 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 1993. https://www.510kdatabase.net/k933053/ 1993-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k933053-abuscreen-onliner-for-cocaine-fda-510k.jpg K933053 - ABUSCREEN ONLINE(R) FOR COCAINE METABOLITE, MODIF K933053 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Aug 1993. https://www.510kdatabase.net/k933304/ 1993-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k933304-anatomic-modular-knee-amk-posterior-fda-510k.jpg K933304 - ANATOMIC MODULAR KNEE (AMK) POSTERIOR STABILIZED K933304 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Aug 1993. https://www.510kdatabase.net/k925362/ 1993-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k925362-sub-q-setr-subcutaneous-infusion-set-fda-510k.jpg K925362 - SUB-Q-SET(R) SUBCUTANEOUS INFUSION SET K925362 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Aug 1993. https://www.510kdatabase.net/k924697/ 1993-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k924697-flexiflo-laparoscopic-gastrostomy-kit-fda-510k.jpg K924697 - FLEXIFLO LAPAROSCOPIC GASTROSTOMY KIT K924697 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1993. https://www.510kdatabase.net/k932249/ 1993-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k932249-durasafe-b-d-combined-spinal-epidural-fda-510k.jpg K932249 - DURASAFE B-D COMBINED SPINAL EPIDURAL ANESTHESIA K932249 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1993. https://www.510kdatabase.net/k932549/ 1993-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k932549-abuscreen-online-low-cutoff-controls-fda-510k.jpg K932549 - ABUSCREEN ONLINE LOW-CUTOFF CONTROLS K932549 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Aug 1993. https://www.510kdatabase.net/k932733/ 1993-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k932733-cordis-catheter-sheath-introducer-fda-510k.jpg K932733 - CORDIS CATHETER SHEATH INTRODUCER K932733 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Aug 1993. https://www.510kdatabase.net/k911000/ 1993-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k911000-percor-stat-dl-85-fr-40cc-intra-aortic-fda-510k.jpg K911000 - PERCOR STAT DL 8.5 FR 40CC INTRA-AORTIC BALLOON K911000 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Aug 1993. https://www.510kdatabase.net/k914802/ 1993-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k914802-datascope-percor-stat-dl95-fr34cc-fda-510k.jpg K914802 - DATASCOPE PERCOR STAT DL9.5 FR34CC INTRA-AORT BALL K914802 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Aug 1993. https://www.510kdatabase.net/k926451/ 1993-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k926451-datascope-multinex-ii-fda-510k.jpg K926451 - DATASCOPE MULTINEX II K926451 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Datascope Corp.. Cleared Aug 1993. https://www.510kdatabase.net/k931891/ 1993-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k931891-triglycerides-fda-510k.jpg K931891 - TRIGLYCERIDES K931891 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Aug 1993. https://www.510kdatabase.net/k932395/ 1993-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k932395-vlc-dr-material-fda-510k.jpg K932395 - VLC DR MATERIAL K932395 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Aug 1993. https://www.510kdatabase.net/k933315/ 1993-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k933315-radias-b12-enzyme-immunoassay-fda-510k.jpg K933315 - RADIAS B12 ENZYME IMMUNOASSAY K933315 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Aug 1993. https://www.510kdatabase.net/k926413/ 1993-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k926413-medtronic-arterial-filter-fda-510k.jpg K926413 - MEDTRONIC ARTERIAL FILTER K926413 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Aug 1993. https://www.510kdatabase.net/k931492/ 1993-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k931492-lapra-ty-suture-clip-fda-510k.jpg K931492 - LAPRA-TY* SUTURE CLIP K931492 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Aug 1993. https://www.510kdatabase.net/k931956/ 1993-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k931956-cascade-m-cat-no-1710-fda-510k.jpg K931956 - CASCADE M, CAT. NO. 1710 K931956 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Aug 1993. https://www.510kdatabase.net/k932273/ 1993-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k932273-cordis-tunneler-fda-510k.jpg K932273 - CORDIS TUNNELER K932273 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cordis Corp.. Cleared Aug 1993. https://www.510kdatabase.net/k933447/ 1993-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k933447-stenoscop-mobile-fluoroscopic-xray-fda-510k.jpg K933447 - STENOSCOP MOBILE FLUOROSCOPIC XRAY SYSTEM K933447 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Aug 1993. https://www.510kdatabase.net/k925947/ 1993-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k925947-b-d-arterial-blood-containment-device-fda-510k.jpg K925947 - B-D ARTERIAL BLOOD CONTAINMENT DEVICE K925947 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1993. https://www.510kdatabase.net/k925952/ 1993-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k925952-medtronic-model-3990-pns-lead-fda-510k.jpg K925952 - MEDTRONIC MODEL 3990 PNS LEAD K925952 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Aug 1993. https://www.510kdatabase.net/k931619/ 1993-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k931619-microvasive-extractor-retrieval-fda-510k.jpg K931619 - MICROVASIVE EXTRACTOR, RETRIEVAL BALLOON CATHETER K931619 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Aug 1993. https://www.510kdatabase.net/k925244/ 1993-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k925244-sensicare-powder-free-medical-glove-fda-510k.jpg K925244 - SENSICARE POWDER FREE MEDICAL GLOVE K925244 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1993. https://www.510kdatabase.net/k930050/ 1993-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k930050-sia-thyroid-stimulating-hormone-elisa-fda-510k.jpg K930050 - SIA THYROID STIMULATING HORMONE ELISA KIT K930050 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Aug 1993. https://www.510kdatabase.net/k930305/ 1993-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k930305-cobas-core-prolactin-eia-fda-510k.jpg K930305 - COBAS CORE PROLACTIN EIA K930305 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Aug 1993. https://www.510kdatabase.net/k931582/ 1993-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k931582-ethylidene-amyl-fda-510k.jpg K931582 - ETHYLIDENE AMYL K931582 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Aug 1993. https://www.510kdatabase.net/k931583/ 1993-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k931583-silyl-amyl-fda-510k.jpg K931583 - SILYL AMYL K931583 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Aug 1993. https://www.510kdatabase.net/k931745/ 1993-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k931745-olympus-reply-urea-nitrogen-reagent-fda-510k.jpg K931745 - OLYMPUS REPLY UREA NITROGEN REAGENT K931745 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Aug 1993. https://www.510kdatabase.net/k925128/ 1993-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k925128-the-karl-storz-11274-series-flexible-fda-510k.jpg K925128 - THE KARL STORZ 11274 SERIES FLEXIBLE FIBERSCOPE K925128 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Aug 1993. https://www.510kdatabase.net/k926514/ 1993-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k926514-endoscopic-ultrasound-system-type-20-fda-510k.jpg K926514 - ENDOSCOPIC ULTRASOUND SYSTEM TYPE 20 K926514 is a FDA 510(k) cleared radiology medical device. Manufacturer: Olympus Corp.. Cleared Aug 1993. https://www.510kdatabase.net/k930007/ 1993-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k930007-immulite-tsh-third-generation-control-fda-510k.jpg K930007 - IMMULITE TSH THIRD GENERATION CONTROL K930007 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Aug 1993. https://www.510kdatabase.net/k931503/ 1993-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k931503-rep-hemoglobin-ief-kits-cat-no-3250-fda-510k.jpg K931503 - REP HEMOGLOBIN IEF KITS (CAT. NO. 3250) K931503 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Aug 1993. https://www.510kdatabase.net/k931703/ 1993-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k931703-immulite-total-ige-fda-510k.jpg K931703 - IMMULITE TOTAL IGE K931703 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Aug 1993. https://www.510kdatabase.net/k931704/ 1993-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k931704-immulite-free-t4-fda-510k.jpg K931704 - IMMULITE FREE T4 K931704 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Aug 1993. https://www.510kdatabase.net/k931740/ 1993-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k931740-cotube-estradiol-radioimmunoassay-fda-510k.jpg K931740 - COTUBE ESTRADIOL RADIOIMMUNOASSAY K931740 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Aug 1993. https://www.510kdatabase.net/k931721/ 1993-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k931721-il-test-fibrinogen-c-fda-510k.jpg K931721 - IL TEST FIBRINOGEN-C K931721 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Aug 1993. https://www.510kdatabase.net/k933317/ 1993-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k933317-lyphochek-endocrine-control-levels-1-fda-510k.jpg K933317 - LYPHOCHEK ENDOCRINE CONTROL, LEVELS 1 AND 2 K933317 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Aug 1993. https://www.510kdatabase.net/k932228/ 1993-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k932228-microvasive-insurg-chloangiographic-fda-510k.jpg K932228 - MICROVASIVE INSURG CHLOANGIOGRAPHIC CATHETER K932228 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Boston Scientific Corp. Cleared Aug 1993. https://www.510kdatabase.net/k933118/ 1993-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k933118-remel-clarithromycin-15-mcg-fda-510k.jpg K933118 - REMEL CLARITHROMYCIN 15 MCG SUSCEPTIBILITY DISK K933118 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Aug 1993. https://www.510kdatabase.net/k932127/ 1993-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k932127-tdxtdxflx-tdxflx-theophylline-fda-510k.jpg K932127 - TDX/TDXFLX & TDXFLX THEOPHYLLINE MONOCLONAL II K932127 is a FDA 510(k) cleared hematology medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1993. https://www.510kdatabase.net/k932459/ 1993-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k932459-fast-set-vinylpolysiloxane-bite-reg-fda-510k.jpg K932459 - FAST SET VINYLPOLYSILOXANE BITE REG. MATERIAL K932459 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Aug 1993. https://www.510kdatabase.net/k933279/ 1993-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k933279-abuscreen-online-benzodiazepines-300-fda-510k.jpg K933279 - ABUSCREEN ONLINE BENZODIAZEPINES 300 CALIBRATOR K933279 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Aug 1993. https://www.510kdatabase.net/k926099/ 1993-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k926099-datascope-6000-monitor-fda-510k.jpg K926099 - DATASCOPE 6000 MONITOR K926099 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Aug 1993. https://www.510kdatabase.net/k930057/ 1993-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k930057-angestat-fluoro-tip-hemostasis-fda-510k.jpg K930057 - ANGESTAT FLUORO-TIP HEMOSTASIS INTRODUCER SET K930057 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: B.Braun Medical, Inc.. Cleared Aug 1993. https://www.510kdatabase.net/k932034/ 1993-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k932034-palavit-55-and-dentacolor-connector-fda-510k.jpg K932034 - PALAVIT 55 AND DENTACOLOR CONNECTOR K932034 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Aug 1993. https://www.510kdatabase.net/k930454/ 1993-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k930454-boehringer-mannheim-coaguchek-system-fda-510k.jpg K930454 - BOEHRINGER MANNHEIM COAGUCHEK SYSTEM K930454 is a FDA 510(k) cleared hematology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Aug 1993. https://www.510kdatabase.net/k930890/ 1993-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k930890-cobasr-core-ige-total-eia-fda-510k.jpg K930890 - COBAS(R) CORE IGE TOTAL EIA K930890 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Aug 1993. https://www.510kdatabase.net/k931123/ 1993-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k931123-digoxin-test-system-kxt-tx-fda-510k.jpg K931123 - DIGOXIN TEST SYSTEM, KXT TX K931123 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Aug 1993. https://www.510kdatabase.net/k931576/ 1993-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k931576-vista-ferritin-assay-fda-510k.jpg K931576 - VISTA FERRITIN ASSAY K931576 is a FDA 510(k) cleared immunology medical device. Manufacturer: Syva Co.. Cleared Aug 1993. https://www.510kdatabase.net/k932251/ 1993-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k932251-rotator-fda-510k.jpg K932251 - ROTATOR K932251 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Aug 1993. https://www.510kdatabase.net/k932957/ 1993-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k932957-quantem-tm-fda-510k.jpg K932957 - QUANTEM (TM) K932957 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Aug 1993. https://www.510kdatabase.net/k933180/ 1993-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k933180-quanta-lite-mitochondria-m2-elisa-fda-510k.jpg K933180 - QUANTA LITE MITOCHONDRIA M2 ELISA K933180 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Aug 1993. https://www.510kdatabase.net/k920427/ 1993-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k920427-percor-stat-dl-95-fr-40cc-intra-aortic-fda-510k.jpg K920427 - PERCOR STAT DL 9.5 FR 40CC INTRA-AORTIC BALLOON K920427 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Aug 1993. https://www.510kdatabase.net/k922103/ 1993-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k922103-iab-anchor-fda-510k.jpg K922103 - IAB ANCHOR K922103 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Datascope Corp.. Cleared Aug 1993. https://www.510kdatabase.net/k922590/ 1993-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k922590-bio-pen-srk-ii-calculator-fda-510k.jpg K922590 - BIO-PEN SRK II CALCULATOR K922590 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Bio-Rad. Cleared Aug 1993. https://www.510kdatabase.net/k925058/ 1993-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k925058-bard-ambu-pump-spik-tub-set-pacret-fda-510k.jpg K925058 - BARD AMBU PUMP SPIK TUB SET PACRET PROVID PUMP SET K925058 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Aug 1993. https://www.510kdatabase.net/k930317/ 1993-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k930317-rep-spe-hi-res-template-system-cat-fda-510k.jpg K930317 - REP SPE HI-RES TEMPLATE SYSTEM, CAT 3276/3277/3278 K930317 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Aug 1993. https://www.510kdatabase.net/k931124/ 1993-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k931124-abuscreen-onliner-calibrators-fda-510k.jpg K931124 - ABUSCREEN ONLINE(R) CALIBRATORS K931124 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Aug 1993. https://www.510kdatabase.net/k931125/ 1993-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k931125-abuscreen-online-control-fda-510k.jpg K931125 - ABUSCREEN ONLINE CONTROL K931125 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Aug 1993. https://www.510kdatabase.net/k931887/ 1993-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k931887-bicarbonate-fda-510k.jpg K931887 - BICARBONATE K931887 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Aug 1993. https://www.510kdatabase.net/k932254/ 1993-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k932254-maxima-filtered-hardshell-reservoir-fda-510k.jpg K932254 - MAXIMA FILTERED HARDSHELL RESERVOIR K932254 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Aug 1993. https://www.510kdatabase.net/k932729/ 1993-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k932729-kodak-ektachem-clinical-chemistry-fda-510k.jpg K932729 - KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (PHOS) K932729 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Aug 1993. https://www.510kdatabase.net/k905663/ 1993-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k905663-pediatric-intra-aortic-balloon-catheters-fda-510k.jpg K905663 - PEDIATRIC INTRA-AORTIC BALLOON CATHETERS K905663 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Aug 1993. https://www.510kdatabase.net/k925556/ 1993-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k925556-argyle-aspir-flex-suction-catheter-fda-510k.jpg K925556 - ARGYLE ASPIR-FLEX SUCTION CATHETER K925556 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sherwood Medical Co.. Cleared Jul 1993. https://www.510kdatabase.net/k920760/ 1993-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k920760-peri-k-pad-cold-pack-fda-510k.jpg K920760 - PERI-K PAD COLD PACK K920760 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jul 1993. https://www.510kdatabase.net/k922418/ 1993-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k922418-video-endoscope-system-fda-510k.jpg K922418 - VIDEO ENDOSCOPE SYSTEM K922418 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jul 1993. https://www.510kdatabase.net/k924511/ 1993-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k924511-monojectr-6-cc-safety-syringe-fda-510k.jpg K924511 - MONOJECT(R) 6 CC SAFETY SYRINGE K924511 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Jul 1993. https://www.510kdatabase.net/k925446/ 1993-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k925446-bard-safe-sampling-device-fda-510k.jpg K925446 - BARD SAFE SAMPLING DEVICE K925446 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jul 1993. https://www.510kdatabase.net/k925910/ 1993-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k925910-hewlett-packard-model-m1018a-fda-510k.jpg K925910 - HEWLETT-PACKARD MODEL M1018A TCPO2/TOPCO2 MODULE K925910 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Jul 1993. https://www.510kdatabase.net/k932092/ 1993-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k932092-usci-angiographic-catheter-fda-510k.jpg K932092 - USCI ANGIOGRAPHIC CATHETER K932092 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jul 1993. https://www.510kdatabase.net/k926107/ 1993-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k926107-arcom-polyethylene-acetabular-liners-fda-510k.jpg K926107 - ARCOM POLYETHYLENE ACETABULAR LINERS & COMPONENTS K926107 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jul 1993. https://www.510kdatabase.net/k931898/ 1993-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k931898-endoswab-fda-510k.jpg K931898 - ENDOSWAB K931898 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medline Industries, Inc.. Cleared Jul 1993. https://www.510kdatabase.net/k931297/ 1993-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k931297-gca-7200a-fda-510k.jpg K931297 - GCA-7200A K931297 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Jul 1993. https://www.510kdatabase.net/k931888/ 1993-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k931888-total-bilirubin-fda-510k.jpg K931888 - TOTAL BILIRUBIN K931888 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jul 1993. https://www.510kdatabase.net/k931889/ 1993-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k931889-creatine-kinase-test-fda-510k.jpg K931889 - CREATINE KINASE TEST K931889 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jul 1993. https://www.510kdatabase.net/k931998/ 1993-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k931998-lcr-generator-fda-510k.jpg K931998 - LCR GENERATOR K931998 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Jul 1993. https://www.510kdatabase.net/k921182/ 1993-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k921182-ultra-high-molecular-weight-fda-510k.jpg K921182 - ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE COMPONENT K921182 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jul 1993. https://www.510kdatabase.net/k931281/ 1993-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k931281-micro-endoscopic-electrode-me2-fda-510k.jpg K931281 - MICRO ENDOSCOPIC ELECTRODE (ME2) K931281 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Jul 1993. https://www.510kdatabase.net/k931995/ 1993-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k931995-resectoscope-sheath-fda-510k.jpg K931995 - RESECTOSCOPE SHEATH K931995 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Corp.. Cleared Jul 1993. https://www.510kdatabase.net/k932725/ 1993-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k932725-b-d-ultra-finer-lancet-fda-510k.jpg K932725 - B-D ULTRA FINE(R) LANCET K932725 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jul 1993. https://www.510kdatabase.net/k930698/ 1993-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k930698-the-model-3003-scaler-fda-510k.jpg K930698 - THE MODEL 3003 SCALER K930698 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jul 1993. https://www.510kdatabase.net/k931890/ 1993-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k931890-glucose-hk-test-fda-510k.jpg K931890 - GLUCOSE-HK TEST K931890 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jul 1993. https://www.510kdatabase.net/k932589/ 1993-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k932589-pediatric-gas-sampling-circuits-fda-510k.jpg K932589 - PEDIATRIC GAS SAMPLING CIRCUITS K932589 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jul 1993. https://www.510kdatabase.net/k932590/ 1993-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k932590-adult-gas-sampling-circuits-fda-510k.jpg K932590 - ADULT GAS SAMPLING CIRCUITS K932590 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jul 1993. https://www.510kdatabase.net/k932753/ 1993-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k932753-roche-abuscreen-tri-level-reference-fda-510k.jpg K932753 - ROCHE ABUSCREEN TRI-LEVEL REFERENCE CONTROLS K932753 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jul 1993. https://www.510kdatabase.net/k932754/ 1993-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k932754-abuscreen-calibration-standard-fda-510k.jpg K932754 - ABUSCREEN CALIBRATION STANDARD K932754 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jul 1993. https://www.510kdatabase.net/k924341/ 1993-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k924341-hayek-oscillatortm-fda-510k.jpg K924341 - HAYEK OSCILLATOR(TM) K924341 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Jul 1993. https://www.510kdatabase.net/k925920/ 1993-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k925920-total-face-mask-fda-510k.jpg K925920 - TOTAL FACE MASK K925920 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Jul 1993. https://www.510kdatabase.net/k932583/ 1993-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k932583-adult-temperature-monitoring-fda-510k.jpg K932583 - ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS K932583 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jul 1993. https://www.510kdatabase.net/k932588/ 1993-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k932588-pediatric-temperature-monitoring-fda-510k.jpg K932588 - PEDIATRIC TEMPERATURE MONITORING CIRCUITS K932588 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jul 1993. https://www.510kdatabase.net/k920429/ 1993-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k920429-modified-model-m1403a-telemetry-fda-510k.jpg K920429 - MODIFIED MODEL M1403A TELEMETRY MONITORING SYSTEM K920429 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Jul 1993. https://www.510kdatabase.net/k923747/ 1993-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k923747-cc-arhythmis-monitoring-option-fda-510k.jpg K923747 - CC ARHYTHMIS MONITORING OPTION K923747 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Jul 1993. https://www.510kdatabase.net/k924721/ 1993-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k924721-baxter-solution-administration-sets-fda-510k.jpg K924721 - BAXTER SOLUTION ADMINISTRATION SETS K924721 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jul 1993. https://www.510kdatabase.net/k926009/ 1993-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k926009-matrix-ccm-600-fda-510k.jpg K926009 - MATRIX CCM 600 K926009 is a FDA 510(k) cleared radiology medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Jul 1993. https://www.510kdatabase.net/k932584/ 1993-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k932584-breathing-bags-fda-510k.jpg K932584 - BREATHING BAGS K932584 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jul 1993. https://www.510kdatabase.net/k932585/ 1993-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k932585-pediatric-anesthesia-circuits-fda-510k.jpg K932585 - PEDIATRIC ANESTHESIA CIRCUITS K932585 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jul 1993. https://www.510kdatabase.net/k932586/ 1993-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k932586-custom-anesthesia-circuits-fda-510k.jpg K932586 - CUSTOM ANESTHESIA CIRCUITS K932586 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jul 1993. https://www.510kdatabase.net/k932587/ 1993-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k932587-coaxial-circuits-fda-510k.jpg K932587 - COAXIAL CIRCUITS K932587 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jul 1993. https://www.510kdatabase.net/k930309/ 1993-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k930309-abbott-encountertmq-fda-510k.jpg K930309 - ABBOTT ENCOUNTER(TM)Q K930309 is a FDA 510(k) cleared hematology medical device. Manufacturer: Abbott Laboratories. Cleared Jul 1993. https://www.510kdatabase.net/k931554/ 1993-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k931554-argelite-85-fda-510k.jpg K931554 - ARGELITE 85 K931554 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jul 1993. https://www.510kdatabase.net/k932615/ 1993-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k932615-tdxrtdxrflxrmehtotrexate-ii-fda-510k.jpg K932615 - TDX(R)/TDX(R)FLX(R)MEHTOTREXATE II K932615 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Jul 1993. https://www.510kdatabase.net/k926217/ 1993-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k926217-terumo-angiographic-catheter-for-fda-510k.jpg K926217 - TERUMO ANGIOGRAPHIC CATHETER FOR LAPOROSCOPIC USE K926217 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Terumo Medical Corp.. Cleared Jul 1993. https://www.510kdatabase.net/k931379/ 1993-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k931379-microvasive-insurg-laptie-suture-ligator-fda-510k.jpg K931379 - MICROVASIVE INSURG LAPTIE SUTURE LIGATOR K931379 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Boston Scientific Corp. Cleared Jul 1993. https://www.510kdatabase.net/k925453/ 1993-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k925453-sherwood-medical-arterial-blood-gas-fda-510k.jpg K925453 - SHERWOOD MEDICAL ARTERIAL BLOOD GAS KIT I K925453 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sherwood Medical Co.. Cleared Jul 1993. https://www.510kdatabase.net/k930847/ 1993-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k930847-argyle-turkel-safety-thoracentesis-fda-510k.jpg K930847 - ARGYLE TURKEL SAFETY THORACENTESIS PROC. TRAY K930847 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Jul 1993. https://www.510kdatabase.net/k924468/ 1993-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k924468-sterile-instrument-traysbasin-sets-fda-510k.jpg K924468 - STERILE INSTRUMENT TRAYS/BASIN SETS K924468 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jul 1993. https://www.510kdatabase.net/k925628/ 1993-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k925628-ultratuff-cut-resistant-glove-liner-fda-510k.jpg K925628 - ULTRATUFF CUT RESISTANT GLOVE LINER K925628 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jul 1993. https://www.510kdatabase.net/k930700/ 1993-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k930700-medlines-repeat-performance-surgical-fda-510k.jpg K930700 - MEDLINES REPEAT PERFORMANCE SURGICAL PACK SYSTEM K930700 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medline Industries, Inc.. Cleared Jul 1993. https://www.510kdatabase.net/k932160/ 1993-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k932160-systemate-creatinine-test-item-number-fda-510k.jpg K932160 - SYSTEMATE CREATININE TEST ITEM NUMBER 65413 K932160 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jul 1993. https://www.510kdatabase.net/k924242/ 1993-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k924242-disposable-perforator-fda-510k.jpg K924242 - DISPOSABLE PERFORATOR K924242 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Jul 1993. https://www.510kdatabase.net/k931229/ 1993-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k931229-variglass-vlc-glass-ionomer-fda-510k.jpg K931229 - VARIGLASS VLC GLASS IONOMER K931229 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jul 1993. https://www.510kdatabase.net/k931475/ 1993-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k931475-argelite-55-fda-510k.jpg K931475 - ARGELITE 55 K931475 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jul 1993. https://www.510kdatabase.net/k931812/ 1993-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k931812-new-dentine-adhesive-fda-510k.jpg K931812 - NEW DENTINE ADHESIVE K931812 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jul 1993. https://www.510kdatabase.net/k931838/ 1993-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k931838-denthesive-ii-fda-510k.jpg K931838 - DENTHESIVE II K931838 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Jul 1993. https://www.510kdatabase.net/k932013/ 1993-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k932013-charisma-modified-fda-510k.jpg K932013 - CHARISMA -- MODIFIED K932013 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Jul 1993. https://www.510kdatabase.net/k932643/ 1993-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k932643-lyphochekr-urine-toxicology-screen-low-fda-510k.jpg K932643 - LYPHOCHEK(R) URINE TOXICOLOGY SCREEN-LOW CONTROL K932643 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bio-Rad. Cleared Jul 1993. https://www.510kdatabase.net/k926143/ 1993-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k926143-angiolapcath-cholangiography-kit-fda-510k.jpg K926143 - ANGIOLAPCATH CHOLANGIOGRAPHY KIT K926143 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jul 1993. https://www.510kdatabase.net/k930889/ 1993-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k930889-roche-cardiotrol-ck-fda-510k.jpg K930889 - ROCHE CARDIOTROL-CK K930889 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jul 1993. https://www.510kdatabase.net/k931465/ 1993-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k931465-rep-alkaline-hb-15-3196-8-3197-4-3198-fda-510k.jpg K931465 - REP ALKALINE HB-15 #3196,-8 #3197,-4 3198 K931465 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Jul 1993. https://www.510kdatabase.net/k931256/ 1993-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k931256-seidel-humeral-locking-nail-fda-510k.jpg K931256 - SEIDEL HUMERAL LOCKING NAIL K931256 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jul 1993. https://www.510kdatabase.net/k931340/ 1993-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k931340-grasp-forcepsscissorsneedle-fda-510k.jpg K931340 - GRASP FORCEPS/SCISSORS/NEEDLE HOLDER/DISSECTOR K931340 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jul 1993. https://www.510kdatabase.net/k931551/ 1993-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k931551-kodak-ektascan-imagelink-system-keis-fda-510k.jpg K931551 - KODAK EKTASCAN IMAGELINK SYSTEM (KEIS) K931551 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Jun 1993. https://www.510kdatabase.net/k932076/ 1993-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k932076-liquichek-spinal-fluid-control-levels-fda-510k.jpg K932076 - LIQUICHEK SPINAL FLUID CONTROL LEVELS I AND II K932076 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Jun 1993. https://www.510kdatabase.net/k932409/ 1993-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k932409-sastm-serumurine-hcg-fda-510k.jpg K932409 - SAS(TM) SERUM/URINE HCG K932409 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sa Scientific, Inc.. Cleared Jun 1993. https://www.510kdatabase.net/k915742/ 1993-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k915742-turbiquant-asl-fda-510k.jpg K915742 - TURBIQUANT ASL K915742 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Jun 1993. https://www.510kdatabase.net/k923663/ 1993-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k923663-multitrol-immunology-control-fda-510k.jpg K923663 - MULTITROL IMMUNOLOGY CONTROL K923663 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Jun 1993. https://www.510kdatabase.net/k925200/ 1993-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k925200-berichrom-heparin-fda-510k.jpg K925200 - BERICHROM HEPARIN K925200 is a FDA 510(k) cleared hematology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Jun 1993. https://www.510kdatabase.net/k915841/ 1993-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k915841-bard-gauderer-universal-percutaneous-fda-510k.jpg K915841 - BARD GAUDERER UNIVERSAL PERCUTANEOUS ENDOSCOPIC K915841 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jun 1993. https://www.510kdatabase.net/k922646/ 1993-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k922646-reference-preparation-for-proteins-in-fda-510k.jpg K922646 - REFERENCE PREPARATION FOR PROTEINS IN HUMAN SERUM K922646 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Jun 1993. https://www.510kdatabase.net/k931018/ 1993-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k931018-karl-storz-495n-series-fiber-optic-fda-510k.jpg K931018 - KARL STORZ 495N SERIES FIBER OPTIC LIGHT CABLES K931018 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jun 1993. https://www.510kdatabase.net/k931310/ 1993-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k931310-glucometer-m-blood-glucose-meter-fda-510k.jpg K931310 - GLUCOMETER M+ BLOOD GLUCOSE METER K931310 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Jun 1993. https://www.510kdatabase.net/k931650/ 1993-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k931650-microvasive-insurg-geenen-cbd-guide-wire-fda-510k.jpg K931650 - MICROVASIVE INSURG GEENEN CBD GUIDE WIRE K931650 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Jun 1993. https://www.510kdatabase.net/k922855/ 1993-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k922855-synthes-universal-spine-rod-and-screw-fda-510k.jpg K922855 - SYNTHES UNIVERSAL SPINE ROD AND SCREW FIXATION SYS K922855 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jun 1993. https://www.510kdatabase.net/k926361/ 1993-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k926361-glucometer-encore-qa-blood-glucose-meter-fda-510k.jpg K926361 - GLUCOMETER ENCORE QA BLOOD GLUCOSE METER K926361 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Jun 1993. https://www.510kdatabase.net/k930697/ 1993-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k930697-medline-sterile-gauze-sponges-fda-510k.jpg K930697 - MEDLINE STERILE GAUZE SPONGES K930697 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medline Industries, Inc.. Cleared Jun 1993. https://www.510kdatabase.net/k922891/ 1993-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k922891-cordis-7-french-thrulumen-catheter-fda-510k.jpg K922891 - CORDIS 7 FRENCH THRULUMEN CATHETER K922891 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Jun 1993. https://www.510kdatabase.net/k915222/ 1993-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k915222-walker-hip-prosthesis-fda-510k.jpg K915222 - WALKER HIP PROSTHESIS K915222 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jun 1993. https://www.510kdatabase.net/k921443/ 1993-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k921443-tip-membrane-assembly-fda-510k.jpg K921443 - TIP & MEMBRANE ASSEMBLY K921443 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Bio-Rad. Cleared Jun 1993. https://www.510kdatabase.net/k921948/ 1993-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k921948-synthes-universal-spine-hook-and-rod-fda-510k.jpg K921948 - SYNTHES UNIVERSAL SPINE HOOK AND ROD FIXATION SYST K921948 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jun 1993. https://www.510kdatabase.net/k923613/ 1993-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k923613-synthes-limited-contact-dynamic-hip-fda-510k.jpg K923613 - SYNTHES LIMITED CONTACT-DYNAMIC HIP SCREW IMPLANT K923613 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jun 1993. https://www.510kdatabase.net/k926138/ 1993-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k926138-carpentier-edwards-physio-annuloplasty-fda-510k.jpg K926138 - CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING K926138 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jun 1993. https://www.510kdatabase.net/k926201/ 1993-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k926201-osteonics-microsutered-femoral-fda-510k.jpg K926201 - OSTEONICS MICROSUTERED FEMORAL COMPONENTES K926201 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Osteonics Corp.. Cleared Jun 1993. https://www.510kdatabase.net/k926226/ 1993-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k926226-intersept-filtered-cardiotomy-reservoir-fda-510k.jpg K926226 - INTERSEPT FILTERED CARDIOTOMY RESERVOIR K926226 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jun 1993. https://www.510kdatabase.net/k930299/ 1993-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k930299-bardr-blood-cardioplegia-heat-fda-510k.jpg K930299 - BARD(R) BLOOD CARDIOPLEGIA HEAT EXCHANGER/TUBE SET K930299 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jun 1993. https://www.510kdatabase.net/k930471/ 1993-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k930471-sherwood-medical-arterial-blood-gas-fda-510k.jpg K930471 - SHERWOOD MEDICAL ARTERIAL BLOOD GAS KIT II K930471 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sherwood Medical Co.. Cleared Jun 1993. https://www.510kdatabase.net/k930685/ 1993-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k930685-technicon-h-3tm-rtc-system-in-vitro-fda-510k.jpg K930685 - TECHNICON H* 3TM RTC SYSTEM (IN-VITRO DIAG.SYST.) K930685 is a FDA 510(k) cleared hematology medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Jun 1993. https://www.510kdatabase.net/k930933/ 1993-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k930933-endopath-endoscopic-surgical-instruments-fda-510k.jpg K930933 - ENDOPATH ENDOSCOPIC SURGICAL INSTRUMENTS K930933 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Jun 1993. https://www.510kdatabase.net/k931237/ 1993-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k931237-endopath-disposable-introducer-fda-510k.jpg K931237 - ENDOPATH* DISPOSABLE INTRODUCER K931237 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Jun 1993. https://www.510kdatabase.net/k931238/ 1993-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k931238-endopath-disposable-knot-pusher-fda-510k.jpg K931238 - ENDOPATH DISPOSABLE KNOT PUSHER K931238 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Jun 1993. https://www.510kdatabase.net/k924098/ 1993-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k924098-il-mcl-2-coagulation-analyzer-fda-510k.jpg K924098 - IL MCL-2 COAGULATION ANALYZER K924098 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jun 1993. https://www.510kdatabase.net/k925126/ 1993-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k925126-interlinktm-injection-site-fda-510k.jpg K925126 - INTERLINK(TM) INJECTION SITE K925126 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jun 1993. https://www.510kdatabase.net/k925196/ 1993-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k925196-bard-epidural-pump-fda-510k.jpg K925196 - BARD EPIDURAL PUMP K925196 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jun 1993. https://www.510kdatabase.net/k930487/ 1993-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k930487-palatray-lc-mint-fda-510k.jpg K930487 - PALATRAY LC MINT K930487 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Jun 1993. https://www.510kdatabase.net/k931382/ 1993-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k931382-11274-ac-flexinble-choledochoscope-fda-510k.jpg K931382 - 11274 AC FLEXINBLE CHOLEDOCHOSCOPE K931382 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jun 1993. https://www.510kdatabase.net/k926232/ 1993-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k926232-alta-cfx-rod-system-fda-510k.jpg K926232 - ALTA CFX ROD SYSTEM K926232 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jun 1993. https://www.510kdatabase.net/k930303/ 1993-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k930303-datascope-multinex-id-plus-fda-510k.jpg K930303 - DATASCOPE MULTINEX ID PLUS K930303 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Datascope Corp.. Cleared Jun 1993. https://www.510kdatabase.net/k931061/ 1993-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k931061-radias-tsh-enzyme-immunoassay-fda-510k.jpg K931061 - RADIAS TSH ENZYME IMMUNOASSAY K931061 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bio-Rad. Cleared Jun 1993. https://www.510kdatabase.net/k931970/ 1993-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k931970-abbott-imx2-analyer-fda-510k.jpg K931970 - ABBOTT IMX2 ANALYER K931970 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1993. https://www.510kdatabase.net/k932067/ 1993-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k932067-ethanol-controls-urine-levels-1ii-and-fda-510k.jpg K932067 - ETHANOL CONTROLS, URINE, LEVELS 1,II, AND III K932067 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Jun 1993. https://www.510kdatabase.net/k924142/ 1993-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k924142-codmantm-titanium-interlaminar-clamp-kit-fda-510k.jpg K924142 - CODMAN(TM) TITANIUM INTERLAMINAR CLAMP KIT K924142 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Jun 1993. https://www.510kdatabase.net/k925201/ 1993-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k925201-exactech-femoral-stem-fda-510k.jpg K925201 - EXACTECH FEMORAL STEM K925201 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Jun 1993. https://www.510kdatabase.net/k925883/ 1993-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k925883-osteonics-microstructured-acetabular-fda-510k.jpg K925883 - OSTEONICS MICROSTRUCTURED ACETABULAR COMPONENTS K925883 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Jun 1993. https://www.510kdatabase.net/k926236/ 1993-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k926236-beckman-anti-streptolysin-o-kit-fda-510k.jpg K926236 - BECKMAN ANTI-STREPTOLYSIN O KIT K926236 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jun 1993. https://www.510kdatabase.net/k930008/ 1993-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k930008-coat-a-count-intact-pth-irma-fda-510k.jpg K930008 - COAT-A-COUNT INTACT PTH IRMA K930008 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jun 1993. https://www.510kdatabase.net/k931172/ 1993-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k931172-imxr-stat-ck-mb-fda-510k.jpg K931172 - IMX(R) STAT CK-MB K931172 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1993. https://www.510kdatabase.net/k931383/ 1993-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k931383-zinc-pva-fda-510k.jpg K931383 - ZINC PVA K931383 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Jun 1993. https://www.510kdatabase.net/k931535/ 1993-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k931535-emitr-dau-barbiturate-assay-fda-510k.jpg K931535 - EMIT(R) D.A.U. BARBITURATE ASSAY K931535 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jun 1993. https://www.510kdatabase.net/k931602/ 1993-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k931602-chemstrip-urine-analyzer-fda-510k.jpg K931602 - CHEMSTRIP URINE ANALYZER K931602 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jun 1993. https://www.510kdatabase.net/k931799/ 1993-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k931799-remel-loracarbef-30-mcg-susceptibility-fda-510k.jpg K931799 - REMEL LORACARBEF 30 MCG SUSCEPTIBILITY DISK K931799 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Jun 1993. https://www.510kdatabase.net/k922576/ 1993-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k922576-aesculap-manual-endoscopic-instruments-fda-510k.jpg K922576 - AESCULAP MANUAL ENDOSCOPIC INSTRUMENTS K922576 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Jun 1993. https://www.510kdatabase.net/k925852/ 1993-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k925852-terumo-coronary-guide-wire-fda-510k.jpg K925852 - TERUMO CORONARY GUIDE WIRE K925852 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Jun 1993. https://www.510kdatabase.net/k931302/ 1993-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k931302-sas-pregnancy-strip-fda-510k.jpg K931302 - SAS PREGNANCY STRIP K931302 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sa Scientific, Inc.. Cleared Jun 1993. https://www.510kdatabase.net/k923069/ 1993-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k923069-restore-tunnel-plug-fda-510k.jpg K923069 - RESTORE TUNNEL PLUG K923069 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jun 1993. https://www.510kdatabase.net/k924400/ 1993-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k924400-clotting-factor-11-vii-x-deficient-fda-510k.jpg K924400 - CLOTTING FACTOR-11,-VII, -X DEFICIENT PLASMA K924400 is a FDA 510(k) cleared hematology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Jun 1993. https://www.510kdatabase.net/k926133/ 1993-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k926133-cort-ex-fda-510k.jpg K926133 - CORT-EX K926133 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jun 1993. https://www.510kdatabase.net/k931074/ 1993-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k931074-du-pont-mv-darkroom-cassette-fda-510k.jpg K931074 - DU PONT MV DARKROOM CASSETTE K931074 is a FDA 510(k) cleared radiology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Jun 1993. https://www.510kdatabase.net/k931283/ 1993-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k931283-microvision-fast-detail-intensifying-fda-510k.jpg K931283 - MICROVISION FAST DETAIL INTENSIFYING SCREEN K931283 is a FDA 510(k) cleared radiology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Jun 1993. https://www.510kdatabase.net/k926422/ 1993-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k926422-vistar-human-follicle-stim-hormonehfsh-fda-510k.jpg K926422 - VISTA(R) HUMAN FOLLICLE-STIM HORMONE(HFSH) ASSAY K926422 is a FDA 510(k) cleared hematology medical device. Manufacturer: Syva Co.. Cleared Jun 1993. https://www.510kdatabase.net/k931289/ 1993-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k931289-remel-cefpodoxime-10-mcg-fda-510k.jpg K931289 - REMEL CEFPODOXIME 10 MCG SUSCEPTIBILITY DISK K931289 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Jun 1993. https://www.510kdatabase.net/k925635/ 1993-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k925635-torus-external-fixation-system-fda-510k.jpg K925635 - TORUS EXTERNAL FIXATION SYSTEM K925635 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jun 1993. https://www.510kdatabase.net/k930504/ 1993-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k930504-new-dentin-primer-fda-510k.jpg K930504 - NEW DENTIN PRIMER K930504 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared May 1993. https://www.510kdatabase.net/k931102/ 1993-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k931102-cordis-nihon-catheter-sheath-introducer-fda-510k.jpg K931102 - CORDIS NIHON CATHETER SHEATH INTRODUCER K931102 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared May 1993. https://www.510kdatabase.net/k926394/ 1993-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k926394-vistar-human-luteinizing-hormonehlh-fda-510k.jpg K926394 - VISTA(R) HUMAN LUTEINIZING HORMONE(HLH) ASSAY K926394 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared May 1993. https://www.510kdatabase.net/k926441/ 1993-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k926441-roche-cobasr-fp-reagent-for-total-t4-fda-510k.jpg K926441 - ROCHE COBAS(R)-FP REAGENT FOR TOTAL T4 THYROX/CALI K926441 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared May 1993. https://www.510kdatabase.net/k930306/ 1993-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k930306-cobas-core-lh-eia-fda-510k.jpg K930306 - COBAS CORE LH EIA K930306 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared May 1993. https://www.510kdatabase.net/k931493/ 1993-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k931493-kodak-ektachem-total-iron-binding-fda-510k.jpg K931493 - KODAK EKTACHEM TOTAL IRON-BINDING CAPACITY KIT K931493 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared May 1993. https://www.510kdatabase.net/k924396/ 1993-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k924396-clotting-factor-viii-ix-xi-xii-fda-510k.jpg K924396 - CLOTTING FACTOR-VIII-IX-XI-XII DEFICIENT PLASMA K924396 is a FDA 510(k) cleared hematology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared May 1993. https://www.510kdatabase.net/k924605/ 1993-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k924605-magnetic-resonance-diagnostic-accessory-fda-510k.jpg K924605 - MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY K924605 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared May 1993. https://www.510kdatabase.net/k924358/ 1993-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k924358-accemt-dgtm-balloon-angioplasty-cath-fda-510k.jpg K924358 - ACCEMT DG(TM) BALLOON ANGIOPLASTY CATH, MODIFIED K924358 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared May 1993. https://www.510kdatabase.net/k925220/ 1993-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k925220-pmi100-video-imager-fda-510k.jpg K925220 - PMI100 VIDEO IMAGER K925220 is a FDA 510(k) cleared radiology medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared May 1993. https://www.510kdatabase.net/k926443/ 1993-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k926443-cobasr-fp-reagents-for-t-fda-510k.jpg K926443 - COBAS(R)-FP REAGENTS FOR T-UPTAKE/CALIBRATORS K926443 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared May 1993. https://www.510kdatabase.net/k931110/ 1993-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k931110-radias-free-t4-enzyme-immunoassay-fda-510k.jpg K931110 - RADIAS FREE T4 ENZYME IMMUNOASSAY K931110 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared May 1993. https://www.510kdatabase.net/k931290/ 1993-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k931290-remel-cefmetazole-30-mcg-fda-510k.jpg K931290 - REMEL CEFMETAZOLE 30 MCG SUSCEPTIBILITY DISK K931290 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared May 1993. https://www.510kdatabase.net/k931049/ 1993-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k931049-advantx-system-fda-510k.jpg K931049 - ADVANTX SYSTEM K931049 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared May 1993. https://www.510kdatabase.net/k930321/ 1993-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k930321-becton-dickinson-dispos-syringes-fda-510k.jpg K930321 - BECTON DICKINSON DISPOS. SYRINGES PLUNGER TIP MOD. K930321 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared May 1993. https://www.510kdatabase.net/k930157/ 1993-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k930157-test-thrombin-fda-510k.jpg K930157 - TEST THROMBIN K930157 is a FDA 510(k) cleared hematology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared May 1993. https://www.510kdatabase.net/k930770/ 1993-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k930770-medtronic-minix-minix-st-pulse-fda-510k.jpg K930770 - MEDTRONIC MINIX & MINIX ST PULSE GENERATORS K930770 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared May 1993. https://www.510kdatabase.net/k930827/ 1993-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k930827-bard-stabilizing-cannula-fda-510k.jpg K930827 - BARD STABILIZING CANNULA K930827 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 1993. https://www.510kdatabase.net/k923066/ 1993-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k923066-flo-gard-2100-2m8281m-fda-510k.jpg K923066 - FLO-GARD 2100 - 2M8281M K923066 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared May 1993. https://www.510kdatabase.net/k923869/ 1993-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k923869-codman-sofwire-titanium-cable-system-fda-510k.jpg K923869 - CODMAN SOF'WIRE TITANIUM CABLE SYSTEM K923869 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared May 1993. https://www.510kdatabase.net/k924455/ 1993-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k924455-synthes-usa-titanium-locked-spiked-fda-510k.jpg K924455 - SYNTHES (USA) TITANIUM LOCKED SPIKED WASHER K924455 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared May 1993. https://www.510kdatabase.net/k925914/ 1993-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k925914-pre-tied-loop-suture-cannula-fda-510k.jpg K925914 - PRE-TIED LOOP SUTURE CANNULA K925914 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared May 1993. https://www.510kdatabase.net/k930489/ 1993-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k930489-amylase-methoddimensionr-clinical-fda-510k.jpg K930489 - AMYLASE METHOD/DIMENSION(R) CLINICAL CHEMISTRY SYS K930489 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared May 1993. https://www.510kdatabase.net/k925715/ 1993-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k925715-rs-optiguard-gown-drape-material-fda-510k.jpg K925715 - RS OPTIGUARD GOWN & DRAPE MATERIAL K925715 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared May 1993. https://www.510kdatabase.net/k930148/ 1993-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k930148-technicon-h-3-rtx-system-in-vitro-diag-fda-510k.jpg K930148 - TECHNICON H* 3 RTX SYSTEM (IN-VITRO DIAG. SYSTEM) K930148 is a FDA 510(k) cleared hematology medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared May 1993. https://www.510kdatabase.net/k930212/ 1993-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k930212-thromboplatin-m-with-calcium-fda-510k.jpg K930212 - THROMBOPLATIN-M WITH CALCIUM K930212 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared May 1993. https://www.510kdatabase.net/k930684/ 1993-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k930684-bard-william-harvey-two-stage-cannula-fda-510k.jpg K930684 - BARD WILLIAM HARVEY TWO STAGE CANNULA K930684 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 1993. https://www.510kdatabase.net/k930878/ 1993-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k930878-bactidroptm-mucap-fda-510k.jpg K930878 - BACTIDROP(TM) MUCAP K930878 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared May 1993. https://www.510kdatabase.net/k931361/ 1993-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k931361-il-test-phosphorus-fda-510k.jpg K931361 - IL TEST PHOSPHORUS K931361 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared May 1993. https://www.510kdatabase.net/k931367/ 1993-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k931367-vacutainer-brand-luer-adapter-fda-510k.jpg K931367 - VACUTAINER BRAND LUER ADAPTER K931367 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared May 1993. https://www.510kdatabase.net/k931409/ 1993-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k931409-immulite-cortisol-fda-510k.jpg K931409 - IMMULITE CORTISOL K931409 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared May 1993. https://www.510kdatabase.net/k931467/ 1993-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k931467-chek-stix-control-strips-for-urinalysis-fda-510k.jpg K931467 - CHEK-STIX CONTROL STRIPS FOR URINALYSIS K931467 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared May 1993. https://www.510kdatabase.net/k931536/ 1993-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k931536-emitr-dau-benzodiazepine-assay-fda-510k.jpg K931536 - EMIT(R) D.A.U. BENZODIAZEPINE ASSAY K931536 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared May 1993. https://www.510kdatabase.net/k930620/ 1993-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k930620-bardr-william-harveyr-arterial-straigh-fda-510k.jpg K930620 - BARD(R) WILLIAM HARVEY(R) ARTERIAL STRAIGH CANNULA K930620 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 1993. https://www.510kdatabase.net/k925131/ 1993-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k925131-cordis-9-f-guiding-catheter-fda-510k.jpg K925131 - CORDIS 9 F GUIDING CATHETER K925131 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared May 1993. https://www.510kdatabase.net/k926245/ 1993-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k926245-abbott-vision-theophylline-iia-fda-510k.jpg K926245 - ABBOTT VISION THEOPHYLLINE IIA K926245 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared May 1993. https://www.510kdatabase.net/k930593/ 1993-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k930593-bard-william-harvey-aortic-root-fda-510k.jpg K930593 - BARD WILLIAM HARVEY AORTIC ROOT CARDIOPLEGIA CANNU K930593 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 1993. https://www.510kdatabase.net/k926037/ 1993-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k926037-harpoon-suture-anchor-fda-510k.jpg K926037 - HARPOON SUTURE ANCHOR K926037 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared May 1993. https://www.510kdatabase.net/k915787/ 1993-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k915787-stability-hip-stem-with-porocoat-fda-510k.jpg K915787 - STABILITY HIP STEM WITH POROCOAT K915787 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Apr 1993. https://www.510kdatabase.net/k922042/ 1993-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k922042-cardifix-endocardial-pacing-lead-fda-510k.jpg K922042 - CARDIFIX ENDOCARDIAL PACING LEAD K922042 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Apr 1993. https://www.510kdatabase.net/k926214/ 1993-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k926214-guide-wire-for-laporoscopic-use-fda-510k.jpg K926214 - GUIDE WIRE FOR LAPOROSCOPIC USE K926214 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Terumo Medical Corp.. Cleared Apr 1993. https://www.510kdatabase.net/k931337/ 1993-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k931337-auto-suture-dilating-cannula-fda-510k.jpg K931337 - AUTO SUTURE DILATING CANNULA K931337 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Apr 1993. https://www.510kdatabase.net/k922235/ 1993-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k922235-system-97-fda-510k.jpg K922235 - SYSTEM 97 K922235 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Apr 1993. https://www.510kdatabase.net/k930022/ 1993-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k930022-sphincterotome-fda-510k.jpg K930022 - SPHINCTEROTOME K930022 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Apr 1993. https://www.510kdatabase.net/k930935/ 1993-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k930935-endopath-tissue-extraction-cannula-fda-510k.jpg K930935 - ENDOPATH TISSUE EXTRACTION CANNULA K930935 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Apr 1993. https://www.510kdatabase.net/k931247/ 1993-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k931247-titan-gel-immunofix-9-cat-no-3051-and-fda-510k.jpg K931247 - TITAN GEL IMMUNOFIX-9 CAT. NO. 3051 AND 3067 K931247 is a FDA 510(k) cleared immunology medical device. Manufacturer: Helena Laboratories. Cleared Apr 1993. https://www.510kdatabase.net/k920736/ 1993-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k920736-ivex-hp96-extended-life-filter-set-fda-510k.jpg K920736 - IVEX-HP96 EXTENDED LIFE FILTER SET K920736 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1993. https://www.510kdatabase.net/k925860/ 1993-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k925860-modified-auto-suture-surgiport-premium-fda-510k.jpg K925860 - MODIFIED AUTO SUTURE SURGIPORT PREMIUM SEAL K925860 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Apr 1993. https://www.510kdatabase.net/k930086/ 1993-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k930086-ortholux-xt-fda-510k.jpg K930086 - ORTHOLUX XT K930086 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Apr 1993. https://www.510kdatabase.net/k925935/ 1993-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k925935-olympus-reply-clinical-chemistry-fda-510k.jpg K925935 - OLYMPUS REPLY CLINICAL CHEMISTRY ANALYZER K925935 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Apr 1993. https://www.510kdatabase.net/k924064/ 1993-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k924064-interlink-universal-vial-adapter-fda-510k.jpg K924064 - INTERLINK UNIVERSAL VIAL ADAPTER K924064 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Apr 1993. https://www.510kdatabase.net/k930166/ 1993-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k930166-iron-test-s-423769342324r1a42324r1b42324-fda-510k.jpg K930166 - IRON TEST #'S 42376/93,42324/R1A,42324/R1B,42324/R K930166 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Apr 1993. https://www.510kdatabase.net/k930479/ 1993-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k930479-nylex-catheters-fda-510k.jpg K930479 - NYLEX CATHETERS K930479 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Apr 1993. https://www.510kdatabase.net/k930898/ 1993-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k930898-radias-automated-immunoassay-system-fda-510k.jpg K930898 - RADIAS AUTOMATED IMMUNOASSAY SYSTEM K930898 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Apr 1993. https://www.510kdatabase.net/k921899/ 1993-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k921899-interlink-system-t-connector-extension-fda-510k.jpg K921899 - INTERLINK SYSTEM - T-CONNECTOR EXTENSION SET K921899 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Apr 1993. https://www.510kdatabase.net/k925695/ 1993-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k925695-omnifit-zirconia-c-taper-femoral-fda-510k.jpg K925695 - OMNIFIT ZIRCONIA C-TAPER FEMORAL BEARING HEAD K925695 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Apr 1993. https://www.510kdatabase.net/k925842/ 1993-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k925842-becton-dickinson-simultrac-component-fda-510k.jpg K925842 - BECTON DICKINSON SIMULTRAC COMPONENT SYSTEM K925842 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1993. https://www.510kdatabase.net/k930208/ 1993-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k930208-cholinesterase-method-for-technicon-fda-510k.jpg K930208 - CHOLINESTERASE METHOD FOR TECHNICON CHEM1/TECHNICO K930208 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Apr 1993. https://www.510kdatabase.net/k930241/ 1993-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k930241-olympus-disposable-biopsy-forceps-fda-510k.jpg K930241 - OLYMPUS DISPOSABLE BIOPSY FORCEPS K930241 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Corp.. Cleared Apr 1993. https://www.510kdatabase.net/k930845/ 1993-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k930845-roche-abuscreen-ontrak-for-methadone-fda-510k.jpg K930845 - ROCHE ABUSCREEN ONTRAK FOR METHADONE K930845 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Apr 1993. https://www.510kdatabase.net/k931050/ 1993-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k931050-cardio-rep-ck-isoenzyme-kit-3310-fda-510k.jpg K931050 - CARDIO REP CK ISOENZYME KIT - 3310 K931050 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Apr 1993. https://www.510kdatabase.net/k915594/ 1993-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k915594-stability-hip-femoral-component-fda-510k.jpg K915594 - STABILITY HIP FEMORAL COMPONENT K915594 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Apr 1993. https://www.510kdatabase.net/k923738/ 1993-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k923738-high-dose-rate-remote-afterloading-fda-510k.jpg K923738 - HIGH DOSE RATE REMOTE AFTERLOADING CATHETER K923738 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cook, Inc.. Cleared Apr 1993. https://www.510kdatabase.net/k923992/ 1993-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k923992-power-pack-350battery-pack-351-fda-510k.jpg K923992 - POWER PACK 350/BATTERY PACK 351 K923992 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 1993. https://www.510kdatabase.net/k923473/ 1993-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k923473-multipurpose-resin-cement-fda-510k.jpg K923473 - MULTIPURPOSE RESIN CEMENT K923473 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Apr 1993. https://www.510kdatabase.net/k930327/ 1993-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k930327-il-testtm-protein-s-fda-510k.jpg K930327 - IL TEST(TM) PROTEIN S K930327 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Apr 1993. https://www.510kdatabase.net/k930359/ 1993-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k930359-cardio-rep-cat-no-1400-ck-isoforms-kit-fda-510k.jpg K930359 - CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305 K930359 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Apr 1993. https://www.510kdatabase.net/k924661/ 1993-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k924661-swan-ganz-intellicath-cco-fda-510k.jpg K924661 - SWAN-GANZ INTELLICATH CCO THERMODILUTION CATHETER K924661 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Apr 1993. https://www.510kdatabase.net/k925176/ 1993-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k925176-vansonnenberg-chest-drainage-catheter-fda-510k.jpg K925176 - VANSONNENBERG CHEST DRAINAGE CATHETER ALL PURPOSE K925176 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Boston Scientific Corp. Cleared Apr 1993. https://www.510kdatabase.net/k925289/ 1993-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k925289-matrix-cr-2050-pmi-3000-fda-510k.jpg K925289 - MATRIX CR 2050, PMI 3000 K925289 is a FDA 510(k) cleared radiology medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Apr 1993. https://www.510kdatabase.net/k923829/ 1993-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k923829-lifecare-175-infuser-modification-fda-510k.jpg K923829 - LIFECARE 175 INFUSER -- MODIFICATION K923829 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1993. https://www.510kdatabase.net/k924382/ 1993-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k924382-bardr-intra-aortic-balloon-fda-510k.jpg K924382 - BARD(R) INTRA AORTIC BALLOON K924382 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 1993. https://www.510kdatabase.net/k930091/ 1993-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k930091-cordis-reflex-steerable-guidewire-fda-510k.jpg K930091 - CORDIS REFLEX STEERABLE GUIDEWIRE K930091 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Apr 1993. https://www.510kdatabase.net/k930342/ 1993-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k930342-becton-dickinson-arterial-blood-gas-kits-fda-510k.jpg K930342 - BECTON DICKINSON ARTERIAL BLOOD GAS KITS K930342 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1993. https://www.510kdatabase.net/k930567/ 1993-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k930567-modified-endoscopic-clamp-fda-510k.jpg K930567 - MODIFIED ENDOSCOPIC CLAMP K930567 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Apr 1993. https://www.510kdatabase.net/k920595/ 1993-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k920595-endopath-interceed-absorbable-adhesion-fda-510k.jpg K920595 - ENDOPATH INTERCEED ABSORBABLE ADHESION BARRIER K920595 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Apr 1993. https://www.510kdatabase.net/k923313/ 1993-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k923313-roche-oxiferm-ii-fda-510k.jpg K923313 - ROCHE OXI/FERM II K923313 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Apr 1993. https://www.510kdatabase.net/k922210/ 1993-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k922210-hewlett-packard-model-78730-carevue-5000-fda-510k.jpg K922210 - HEWLETT-PACKARD MODEL 78730 CAREVUE 5000 K922210 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Apr 1993. https://www.510kdatabase.net/k926120/ 1993-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k926120-contour-femoral-hip-stem-with-porocoat-fda-510k.jpg K926120 - CONTOUR FEMORAL HIP STEM WITH POROCOAT K926120 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Mar 1993. https://www.510kdatabase.net/k926406/ 1993-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k926406-dual-cure-reline-material-fda-510k.jpg K926406 - DUAL CURE RELINE MATERIAL K926406 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Mar 1993. https://www.510kdatabase.net/k922797/ 1993-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k922797-aesculap-trocar-instrument-set-fda-510k.jpg K922797 - AESCULAP TROCAR INSTRUMENT SET K922797 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Mar 1993. https://www.510kdatabase.net/k926116/ 1993-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k926116-codman-sofwiretm-kit-fda-510k.jpg K926116 - CODMAN SOFWIRE(TM) KIT K926116 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Mar 1993. https://www.510kdatabase.net/k926231/ 1993-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k926231-duracon-unicompartmental-knee-system-fda-510k.jpg K926231 - DURACON UNICOMPARTMENTAL KNEE SYSTEM K926231 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Mar 1993. https://www.510kdatabase.net/k926386/ 1993-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k926386-vista-prolactin-assay-fda-510k.jpg K926386 - VISTA PROLACTIN ASSAY K926386 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Mar 1993. https://www.510kdatabase.net/k926469/ 1993-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k926469-varianttm-hemoglobin-a-1c-program-fda-510k.jpg K926469 - VARIANT(TM) HEMOGLOBIN A 1C PROGRAM K926469 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bio-Rad. Cleared Mar 1993. https://www.510kdatabase.net/k930609/ 1993-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k930609-sastm-monoclonal-hcg-slide-fda-510k.jpg K930609 - SAS(TM) MONOCLONAL HCG-SLIDE K930609 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sa Scientific, Inc.. Cleared Mar 1993. https://www.510kdatabase.net/k922214/ 1993-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k922214-empty-viaflex-plastic-container-fda-510k.jpg K922214 - EMPTY VIAFLEX PLASTIC CONTAINER K922214 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 1993. https://www.510kdatabase.net/k922431/ 1993-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k922431-bard-latex-urinary-catheters-fda-510k.jpg K922431 - BARD LATEX URINARY CATHETERS K922431 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 1993. https://www.510kdatabase.net/k925329/ 1993-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k925329-culturette-brand-toxin-cd-test-fda-510k.jpg K925329 - CULTURETTE BRAND TOXIN CD TEST K925329 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1993. https://www.510kdatabase.net/k915837/ 1993-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k915837-non-balloon-replacement-gastrostomy-fda-510k.jpg K915837 - NON-BALLOON REPLACEMENT GASTROSTOMY SYSTEM K915837 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 1993. https://www.510kdatabase.net/k920979/ 1993-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k920979-codman-steerable-endoscope-cat-83-1340-fda-510k.jpg K920979 - CODMAN STEERABLE ENDOSCOPE (CAT.# 83-1340) K920979 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Mar 1993. https://www.510kdatabase.net/k923555/ 1993-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k923555-codman-gaab-neuroendoscope-fda-510k.jpg K923555 - CODMAN GAAB NEUROENDOSCOPE K923555 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Mar 1993. https://www.510kdatabase.net/k920446/ 1993-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k920446-total-toe-system-fda-510k.jpg K920446 - TOTAL TOE SYSTEM K920446 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Mar 1993. https://www.510kdatabase.net/k923483/ 1993-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k923483-bard-william-harvey-aortic-arch-canulae-fda-510k.jpg K923483 - BARD WILLIAM HARVEY AORTIC ARCH CANULAE K923483 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 1993. https://www.510kdatabase.net/k925127/ 1993-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k925127-alta-cancellous-bone-screw-fda-510k.jpg K925127 - ALTA CANCELLOUS BONE SCREW K925127 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Mar 1993. https://www.510kdatabase.net/k925901/ 1993-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k925901-kinemaxr-condylar-total-knee-syst-fda-510k.jpg K925901 - KINEMAX(R) CONDYLAR TOTAL KNEE SYST FEMORAL SPACER K925901 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Mar 1993. https://www.510kdatabase.net/k923477/ 1993-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k923477-35mm-universal-compression-screw-fda-510k.jpg K923477 - 3.5MM UNIVERSAL COMPRESSION SCREW K923477 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Mar 1993. https://www.510kdatabase.net/k920594/ 1993-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k920594-shiley-perfusion-tubing-sets-fda-510k.jpg K920594 - SHILEY PERFUSION TUBING SETS K920594 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Mar 1993. https://www.510kdatabase.net/k921164/ 1993-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k921164-model-1300-softrace-ii-electrode-fda-510k.jpg K921164 - MODEL 1300 SOFTRACE II ELECTRODE K921164 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Mar 1993. https://www.510kdatabase.net/k923931/ 1993-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k923931-medtronic-model-3487a-pisces-quad-lead-fda-510k.jpg K923931 - MEDTRONIC MODEL 3487A PISCES-QUAD LEAD K923931 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Mar 1993. https://www.510kdatabase.net/k924070/ 1993-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k924070-b-d-pen-needle-fda-510k.jpg K924070 - B-D PEN NEEDLE K924070 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1993. https://www.510kdatabase.net/k924522/ 1993-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k924522-medtronic-model-3080-pisces-quad-lead-fda-510k.jpg K924522 - MEDTRONIC MODEL 3080 PISCES-QUAD LEAD K924522 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Mar 1993. https://www.510kdatabase.net/k926550/ 1993-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k926550-unix-link-fda-510k.jpg K926550 - UNIX-LINK K926550 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Mar 1993. https://www.510kdatabase.net/k930640/ 1993-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k930640-precise-pregnancy-fda-510k.jpg K930640 - PRECISE PREGNANCY K930640 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1993. https://www.510kdatabase.net/k923573/ 1993-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k923573-duracon-metal-backed-patella-fda-510k.jpg K923573 - DURACON METAL BACKED PATELLA K923573 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Mar 1993. https://www.510kdatabase.net/k925996/ 1993-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k925996-arthroscopic-acl-cannulated-drills-and-fda-510k.jpg K925996 - ARTHROSCOPIC ACL CANNULATED DRILLS AND SLEEVES K925996 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Mar 1993. https://www.510kdatabase.net/k926062/ 1993-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k926062-arthroscopic-knee-instruments-fda-510k.jpg K926062 - ARTHROSCOPIC KNEE INSTRUMENTS K926062 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Mar 1993. https://www.510kdatabase.net/k926111/ 1993-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k926111-arthroscopic-knee-instruments-fda-510k.jpg K926111 - ARTHROSCOPIC KNEE INSTRUMENTS K926111 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Mar 1993. https://www.510kdatabase.net/k926193/ 1993-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k926193-arthrex-instruments-shoulder-gp-1-fda-510k.jpg K926193 - ARTHREX INSTRUMENTS (SHOULDER GP. 1) K926193 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Mar 1993. https://www.510kdatabase.net/k930215/ 1993-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k930215-flexible-trocar-tubes-fda-510k.jpg K930215 - FLEXIBLE TROCAR TUBES K930215 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Olympus Corp.. Cleared Mar 1993. https://www.510kdatabase.net/k930485/ 1993-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k930485-quanta-litetm-thyroid-m-elisa-fda-510k.jpg K930485 - QUANTA LITE(TM) THYROID M ELISA K930485 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Mar 1993. https://www.510kdatabase.net/k923982/ 1993-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k923982-olympus-oes-laparoscopy-system-fda-510k.jpg K923982 - OLYMPUS OES LAPAROSCOPY SYSTEM K923982 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Olympus Corp.. Cleared Mar 1993. https://www.510kdatabase.net/k926258/ 1993-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k926258-dlx-fda-510k.jpg K926258 - DLX K926258 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Mar 1993. https://www.510kdatabase.net/k930486/ 1993-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k930486-quanta-litetm-thyroid-t-elisa-fda-510k.jpg K930486 - QUANTA LITE(TM) THYROID T ELISA K930486 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Mar 1993. https://www.510kdatabase.net/k924122/ 1993-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k924122-variant-beta-thalassemia-short-program-fda-510k.jpg K924122 - VARIANT BETA-THALASSEMIA SHORT PROGRAM K924122 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bio-Rad. Cleared Mar 1993. https://www.510kdatabase.net/k930162/ 1993-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k930162-aca-digoxin-analytical-test-pack-fda-510k.jpg K930162 - ACA DIGOXIN ANALYTICAL TEST PACK K930162 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Mar 1993. https://www.510kdatabase.net/k930621/ 1993-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k930621-tina-quant-crp-fda-510k.jpg K930621 - TINA-QUANT CRP K930621 is a FDA 510(k) cleared immunology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Mar 1993. https://www.510kdatabase.net/k923444/ 1993-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k923444-servo-graphics-fda-510k.jpg K923444 - SERVO GRAPHICS K923444 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 1993. https://www.510kdatabase.net/k925846/ 1993-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k925846-immulite-prolactin-fda-510k.jpg K925846 - IMMULITE PROLACTIN K925846 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Mar 1993. https://www.510kdatabase.net/k920823/ 1993-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k920823-welter-snare-retriever-fda-510k.jpg K920823 - WELTER SNARE RETRIEVER K920823 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Mar 1993. https://www.510kdatabase.net/k923861/ 1993-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k923861-luhr-pan-fixation-system-fda-510k.jpg K923861 - LUHR PAN FIXATION SYSTEM K923861 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Mar 1993. https://www.510kdatabase.net/k925456/ 1993-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k925456-arthroscopic-instruments-fda-510k.jpg K925456 - ARTHROSCOPIC INSTRUMENTS K925456 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Mar 1993. https://www.510kdatabase.net/k925457/ 1993-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k925457-arthrex-bayonet-knife-fda-510k.jpg K925457 - ARTHREX BAYONET KNIFE K925457 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Mar 1993. https://www.510kdatabase.net/k925458/ 1993-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k925458-arthrex-ring-curette-fda-510k.jpg K925458 - ARTHREX RING CURETTE K925458 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Mar 1993. https://www.510kdatabase.net/k925544/ 1993-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k925544-seidel-humeral-locking-nail-additional-fda-510k.jpg K925544 - SEIDEL HUMERAL LOCKING NAIL & ADDITIONAL LENGTHS K925544 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Mar 1993. https://www.510kdatabase.net/k925814/ 1993-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k925814-arthrex-instruments-basic-fda-510k.jpg K925814 - ARTHREX INSTRUMENTS (BASIC) K925814 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Mar 1993. https://www.510kdatabase.net/k925884/ 1993-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k925884-arthroscopic-retractors-and-graspers-fda-510k.jpg K925884 - ARTHROSCOPIC RETRACTORS AND GRASPERS K925884 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Mar 1993. https://www.510kdatabase.net/k925954/ 1993-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k925954-arthrex-instruments-basic-fda-510k.jpg K925954 - ARTHREX INSTRUMENTS (BASIC) K925954 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Mar 1993. https://www.510kdatabase.net/k925986/ 1993-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k925986-arthroscopic-acl-drill-system-fda-510k.jpg K925986 - ARTHROSCOPIC ACL DRILL SYSTEM K925986 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Mar 1993. https://www.510kdatabase.net/k925995/ 1993-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k925995-arthrex-instruments-knee-gp-3-fda-510k.jpg K925995 - ARTHREX INSTRUMENTS (KNEE, GP 3) K925995 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Mar 1993. https://www.510kdatabase.net/k926304/ 1993-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k926304-bactec-peds-plusf-fda-510k.jpg K926304 - BACTEC PEDS PLUS/F K926304 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1993. https://www.510kdatabase.net/k926404/ 1993-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k926404-kodak-x-omatic-identification-camera-fda-510k.jpg K926404 - KODAK X-OMATIC IDENTIFICATION CAMERA, MODEL 4 & 4L K926404 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Mar 1993. https://www.510kdatabase.net/k926562/ 1993-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k926562-quanta-litetm-jo-1-elisa-kit-fda-510k.jpg K926562 - QUANTA LITE(TM) JO-1 ELISA KIT K926562 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Mar 1993. https://www.510kdatabase.net/k925074/ 1993-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k925074-usci-lumisilk-guide-wire-with-propel-fda-510k.jpg K925074 - USCI LUMISILK GUIDE WIRE WITH PRO/PEL COATING K925074 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 1993. https://www.510kdatabase.net/k925988/ 1993-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k925988-multifibren-fda-510k.jpg K925988 - MULTIFIBREN K925988 is a FDA 510(k) cleared hematology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Mar 1993. https://www.510kdatabase.net/k925721/ 1993-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k925721-kodak-ektascan-cp-primary-high-freq-fda-510k.jpg K925721 - KODAK EKTASCAN CP PRIMARY HIGH FREQ. VID.INTERFACE K925721 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Feb 1993. https://www.510kdatabase.net/k930269/ 1993-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k930269-cobas-fp-tdm-controls-fda-510k.jpg K930269 - COBAS-FP TDM CONTROLS K930269 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Feb 1993. https://www.510kdatabase.net/k925101/ 1993-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k925101-systemate-plus-calibrator-fda-510k.jpg K925101 - SYSTEMATE PLUS CALIBRATOR K925101 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Feb 1993. https://www.510kdatabase.net/k926450/ 1993-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k926450-edslabr-dual-lumen-region-satur-fda-510k.jpg K926450 - EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATH K926450 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Feb 1993. https://www.510kdatabase.net/k926342/ 1993-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k926342-vistar-human-chorionic-gonadotropin-fda-510k.jpg K926342 - VISTA(R) HUMAN CHORIONIC GONADOTROPIN (HCG) ASSAY K926342 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Feb 1993. https://www.510kdatabase.net/k922939/ 1993-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k922939-bard-monopty-disposable-core-biopsy-fda-510k.jpg K922939 - BARD MONOPTY DISPOSABLE CORE BIOPSY ISNT. W/ CENT. K922939 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Feb 1993. https://www.510kdatabase.net/k923554/ 1993-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k923554-kodak-ektascan-fda-510k.jpg K923554 - KODAK EKTASCAN K923554 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Feb 1993. https://www.510kdatabase.net/k924439/ 1993-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k924439-becton-dickinson-interlink-vial-access-fda-510k.jpg K924439 - BECTON DICKINSON INTERLINK VIAL ACCESS CANNULA K924439 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Feb 1993. https://www.510kdatabase.net/k925148/ 1993-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k925148-auto-suture-surgical-mesh-deployer-fda-510k.jpg K925148 - AUTO SUTURE SURGICAL MESH DEPLOYER K925148 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Feb 1993. https://www.510kdatabase.net/k925372/ 1993-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k925372-osteonicsr-700-series-total-knee-mod-fda-510k.jpg K925372 - OSTEONICS(R) 700 SERIES TOTAL KNEE MOD FEMOR COMP K925372 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Feb 1993. https://www.510kdatabase.net/k925833/ 1993-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k925833-cordis-steerable-guidewire-fda-510k.jpg K925833 - CORDIS STEERABLE GUIDEWIRE K925833 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Feb 1993. https://www.510kdatabase.net/k926060/ 1993-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k926060-synchron-cx5ce-clinical-analyzer-fda-510k.jpg K926060 - SYNCHRON CX5CE CLINICAL ANALYZER K926060 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Feb 1993. https://www.510kdatabase.net/k926122/ 1993-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k926122-fluorex-fda-510k.jpg K926122 - FLUOREX K926122 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Feb 1993. https://www.510kdatabase.net/k926222/ 1993-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k926222-owrens-veronal-buffer-5375-fibronogen-fda-510k.jpg K926222 - OWREN'S VERONAL BUFFER #5375 & FIBRONOGEN KIT#5376 K926222 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Feb 1993. https://www.510kdatabase.net/k921638/ 1993-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k921638-system-90-intra-aortic-balloon-pump-fda-510k.jpg K921638 - SYSTEM 90 INTRA-AORTIC BALLOON PUMP CONSOLE K921638 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Feb 1993. https://www.510kdatabase.net/k923343/ 1993-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k923343-hewlett-packard-model-m1020a-pulse-fda-510k.jpg K923343 - HEWLETT-PACKARD MODEL M1020A PULSE OXIMETER K923343 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Feb 1993. https://www.510kdatabase.net/k915424/ 1993-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k915424-arthrex-cannulated-interference-screw-fda-510k.jpg K915424 - ARTHREX CANNULATED INTERFERENCE SCREW K915424 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Feb 1993. https://www.510kdatabase.net/k923142/ 1993-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k923142-arthrex-plus-fda-510k.jpg K923142 - ARTHREX PLUS K923142 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Feb 1993. https://www.510kdatabase.net/k922890/ 1993-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k922890-arthrex-knee-arthroscopic-surgery-fda-510k.jpg K922890 - ARTHREX KNEE ARTHROSCOPIC SURGERY ACCESSORIES K922890 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Feb 1993. https://www.510kdatabase.net/k924368/ 1993-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k924368-olympus-albumin-reagent-fda-510k.jpg K924368 - OLYMPUS ALBUMIN REAGENT K924368 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Feb 1993. https://www.510kdatabase.net/k925455/ 1993-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k925455-arthrex-atraumatic-mini-grasper-fda-510k.jpg K925455 - ARTHREX ATRAUMATIC MINI-GRASPER K925455 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Feb 1993. https://www.510kdatabase.net/k925603/ 1993-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k925603-olympus-cholesterol-reagent-fda-510k.jpg K925603 - OLYMPUS CHOLESTEROL REAGENT K925603 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Feb 1993. https://www.510kdatabase.net/k925879/ 1993-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k925879-microvasive-insurg-flat-wire-baskets-fda-510k.jpg K925879 - MICROVASIVE INSURG FLAT WIRE BASKETS K925879 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Feb 1993. https://www.510kdatabase.net/k920234/ 1993-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k920234-davol-laparoscopic-dissectors-fda-510k.jpg K920234 - DAVOL LAPAROSCOPIC DISSECTORS K920234 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Feb 1993. https://www.510kdatabase.net/k922382/ 1993-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k922382-intermater-lv-elastomeric-infusion-fda-510k.jpg K922382 - INTERMATE(R) LV ELASTOMERIC INFUSION DEVICE K922382 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Feb 1993. https://www.510kdatabase.net/k923079/ 1993-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k923079-il-test-calibration-set-apo-a1b-fda-510k.jpg K923079 - IL TEST CALIBRATION SET APO A1B K923079 is a FDA 510(k) cleared immunology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Feb 1993. https://www.510kdatabase.net/k924703/ 1993-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k924703-lactate-dehydrogenase-ld-test-item-65418-fda-510k.jpg K924703 - LACTATE DEHYDROGENASE (LD) TEST ITEM #65418 K924703 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Feb 1993. https://www.510kdatabase.net/k925188/ 1993-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k925188-abbott-quickstart-ld-1-modification-fda-510k.jpg K925188 - ABBOTT QUICKSTART LD-1, MODIFICATION K925188 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Feb 1993. https://www.510kdatabase.net/k925339/ 1993-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k925339-olylmpus-alanine-aminotransferase-fda-510k.jpg K925339 - OLYLMPUS ALANINE AMINOTRANSFERASE REAGENT K925339 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Feb 1993. https://www.510kdatabase.net/k925626/ 1993-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k925626-maxima-plus-hollow-fiber-oxygenator-fda-510k.jpg K925626 - MAXIMA PLUS HOLLOW FIBER OXYGENATOR K925626 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Feb 1993. https://www.510kdatabase.net/k925863/ 1993-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k925863-spuncrit-fda-510k.jpg K925863 - SPUNCRIT K925863 is a FDA 510(k) cleared hematology medical device. Manufacturer: bioMerieux, Inc.. Cleared Feb 1993. https://www.510kdatabase.net/k925880/ 1993-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k925880-kodak-amerlite-ck-mb-control-sera-fda-510k.jpg K925880 - KODAK AMERLITE CK-MB CONTROL SERA LAN.4413 K925880 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Feb 1993. https://www.510kdatabase.net/k923696/ 1993-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k923696-cordis-viera-guidewire-fda-510k.jpg K923696 - CORDIS VIERA GUIDEWIRE K923696 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Feb 1993. https://www.510kdatabase.net/k923077/ 1993-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k923077-advantage-windows-3d-option-and-fda-510k.jpg K923077 - ADVANTAGE WINDOWS 3D OPTION AND DENTASCAN OPTION K923077 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Feb 1993. https://www.510kdatabase.net/k925263/ 1993-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k925263-meridian-medical-systems-connectors-fda-510k.jpg K925263 - MERIDIAN MEDICAL SYSTEMS CONNECTORS & AIRWAY EXT K925263 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Feb 1993. https://www.510kdatabase.net/k925845/ 1993-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k925845-vista-hphpq-system-fda-510k.jpg K925845 - VISTA HP/HPQ SYSTEM K925845 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Feb 1993. https://www.510kdatabase.net/k926204/ 1993-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k926204-sas-one-step-pregnancy-fda-510k.jpg K926204 - SAS ONE STEP PREGNANCY K926204 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sa Scientific, Inc.. Cleared Feb 1993. https://www.510kdatabase.net/k922123/ 1993-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k922123-auto-suture-disposable-endoscopic-fda-510k.jpg K922123 - AUTO SUTURE DISPOSABLE ENDOSCOPIC SPECIMEN POUCH K922123 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Feb 1993. https://www.510kdatabase.net/k914702/ 1993-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k914702-sterile-viewtm-knee-high-bootsdepuy-fda-510k.jpg K914702 - STERILE VIEW(TM) KNEE-HIGH BOOTS/DEPUY SHOE BOOTS K914702 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Depuy, Inc.. Cleared Jan 1993. https://www.510kdatabase.net/k914583/ 1993-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k914583-tosbee-fda-510k.jpg K914583 - TOSBEE K914583 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Jan 1993. https://www.510kdatabase.net/k924508/ 1993-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k924508-cholesterol-test-item-4237493-42322r1-fda-510k.jpg K924508 - CHOLESTEROL TEST ITEM# 42374/93, 42322/R1 K924508 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jan 1993. https://www.510kdatabase.net/k925364/ 1993-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k925364-mridian-medical-systems-ventlator-hoses-fda-510k.jpg K925364 - MRIDIAN MEDICAL SYSTEMS VENTLATOR HOSES K925364 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jan 1993. https://www.510kdatabase.net/k926359/ 1993-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k926359-clinitek-200-urine-chemistry-analyzer-fda-510k.jpg K926359 - CLINITEK 200+ URINE CHEMISTRY ANALYZER K926359 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Jan 1993. https://www.510kdatabase.net/k920305/ 1993-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k920305-pharmaseal-clear-hub-spinal-needle-fda-510k.jpg K920305 - PHARMASEAL CLEAR HUB SPINAL NEEDLE K920305 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jan 1993. https://www.510kdatabase.net/k922811/ 1993-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k922811-roche-cobas-futura-glucose-fda-510k.jpg K922811 - ROCHE COBAS FUTURA GLUCOSE K922811 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jan 1993. https://www.510kdatabase.net/k926144/ 1993-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k926144-urine-magnesium-method-for-technicon-fda-510k.jpg K926144 - URINE MAGNESIUM METHOD FOR TECHNICON CHEM SYSTEMS K926144 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Jan 1993. https://www.510kdatabase.net/k923334/ 1993-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k923334-milne-charkot-shott-thur-cassette-holder-fda-510k.jpg K923334 - MILNE-CHARKOT SHOTT-THUR CASSETTE HOLDER K923334 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cook, Inc.. Cleared Jan 1993. https://www.510kdatabase.net/k924078/ 1993-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k924078-polydoros-c-fda-510k.jpg K924078 - POLYDOROS C K924078 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 1993. https://www.510kdatabase.net/k924488/ 1993-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k924488-kodak-ektachem-clinical-chemistry-fda-510k.jpg K924488 - KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LI) K924488 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Jan 1993. https://www.510kdatabase.net/k924710/ 1993-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k924710-triglycerides-fda-510k.jpg K924710 - TRIGLYCERIDES K924710 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jan 1993. https://www.510kdatabase.net/k925110/ 1993-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k925110-abbott-imx-t4-fda-510k.jpg K925110 - ABBOTT IMX T4 K925110 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jan 1993. https://www.510kdatabase.net/k925113/ 1993-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k925113-olympus-uric-acid-reagent-fda-510k.jpg K925113 - OLYMPUS URIC ACID REAGENT K925113 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Jan 1993. https://www.510kdatabase.net/k925149/ 1993-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k925149-auto-suture-endoscopic-knot-pusher-fda-510k.jpg K925149 - AUTO SUTURE ENDOSCOPIC KNOT PUSHER K925149 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Jan 1993. https://www.510kdatabase.net/k925155/ 1993-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k925155-olympus-aspartate-aminotransferase-fda-510k.jpg K925155 - OLYMPUS ASPARTATE AMINOTRANSFERASE REAGENT K925155 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Jan 1993. https://www.510kdatabase.net/k925217/ 1993-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k925217-meridian-medical-systems-breathing-fda-510k.jpg K925217 - MERIDIAN MEDICAL SYSTEMS BREATHING FILTER K925217 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jan 1993. https://www.510kdatabase.net/k925231/ 1993-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k925231-meridian-medical-systems-mapleson-d-fda-510k.jpg K925231 - MERIDIAN MEDICAL SYSTEMS MAPLESON D CIRCUITS K925231 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jan 1993. https://www.510kdatabase.net/k925337/ 1993-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k925337-olympus-gamma-glutamyl-transferase-fda-510k.jpg K925337 - OLYMPUS GAMMA GLUTAMYL TRANSFERASE REAGENT K925337 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Jan 1993. https://www.510kdatabase.net/k925547/ 1993-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k925547-maxsoftware-fda-510k.jpg K925547 - MAXSOFTWARE K925547 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jan 1993. https://www.510kdatabase.net/k922972/ 1993-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k922972-models-438-05-and-435-05-implantable-fda-510k.jpg K922972 - MODELS 438-05 AND 435-05 IMPLANTABLE PACING LEAD K922972 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Jan 1993. https://www.510kdatabase.net/k925167/ 1993-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k925167-mass-spectrometry-monitoring-line-fda-510k.jpg K925167 - MASS SPECTROMETRY MONITORING LINE CONONECTORS K925167 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jan 1993. https://www.510kdatabase.net/k925232/ 1993-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k925232-meridian-medical-systems-adult-anes-fda-510k.jpg K925232 - MERIDIAN MEDICAL SYSTEMS ADULT ANES BREATH CIRCUIT K925232 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jan 1993. https://www.510kdatabase.net/k925262/ 1993-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k925262-meridian-medical-systems-volume-fda-510k.jpg K925262 - MERIDIAN MEDICAL SYSTEMS VOLUME VENTILATOR CIRCUIT K925262 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jan 1993. https://www.510kdatabase.net/k925419/ 1993-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k925419-passage-hemostasis-valve-fda-510k.jpg K925419 - PASSAGE HEMOSTASIS VALVE K925419 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jan 1993. https://www.510kdatabase.net/k923580/ 1993-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k923580-synthes-ti-6ai-7nb-unreamed-femoral-nail-fda-510k.jpg K923580 - SYNTHES TI-6AI-7NB UNREAMED FEMORAL NAIL K923580 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jan 1993. https://www.510kdatabase.net/k923597/ 1993-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k923597-synthes-titanium-unreamed-femoral-nail-fda-510k.jpg K923597 - SYNTHES TITANIUM UNREAMED FEMORAL NAIL K923597 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jan 1993. https://www.510kdatabase.net/k924310/ 1993-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k924310-prestilix-1694-d-image-intensified-fda-510k.jpg K924310 - PRESTILIX 1694 D IMAGE INTENSIFIED FLUOROSCCOPIC K924310 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Jan 1993. https://www.510kdatabase.net/k920587/ 1993-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k920587-physiological-measurement-and-display-fda-510k.jpg K920587 - PHYSIOLOGICAL MEASUREMENT AND DISPLAY SYSTEMS K920587 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 1993. https://www.510kdatabase.net/k924489/ 1993-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k924489-software-version-a25-for-magnetom-fda-510k.jpg K924489 - SOFTWARE VERSION A2.5 FOR MAGNETOM 42SP/63SP SYST K924489 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 1993. https://www.510kdatabase.net/k924813/ 1993-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k924813-variant-sickle-cell-short-program-fda-510k.jpg K924813 - VARIANT SICKLE CELL SHORT PROGRAM K924813 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bio-Rad. Cleared Jan 1993. https://www.510kdatabase.net/k924884/ 1993-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k924884-il-testtm-pro-chrom-fda-510k.jpg K924884 - IL TEST(TM) PRO-CHROM K924884 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jan 1993. https://www.510kdatabase.net/k925902/ 1993-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k925902-b-d-loss-of-resistance-syringe-fda-510k.jpg K925902 - B-D LOSS OF RESISTANCE SYRINGE K925902 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jan 1993. https://www.510kdatabase.net/k925377/ 1993-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k925377-imx-pap-fda-510k.jpg K925377 - IMX PAP K925377 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jan 1993. https://www.510kdatabase.net/k925848/ 1993-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k925848-immulite-ferritin-fda-510k.jpg K925848 - IMMULITE FERRITIN K925848 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jan 1993. https://www.510kdatabase.net/k915226/ 1993-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k915226-isothermal-heated-ventilator-fda-510k.jpg K915226 - ISOTHERMAL HEATED VENTILATOR & ANESTHESIA CIRCUIT K915226 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jan 1993. https://www.510kdatabase.net/k925204/ 1993-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k925204-beckman-diatrac-hemoglob-a1c-electro-fda-510k.jpg K925204 - BECKMAN DIATRAC HEMOGLOB A1C ELECTRO KIT, MODIFIED K925204 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jan 1993. https://www.510kdatabase.net/k926067/ 1993-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k926067-emitr-ii-benzodiazepine-assay-fda-510k.jpg K926067 - EMIT(R) II BENZODIAZEPINE ASSAY K926067 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jan 1993. https://www.510kdatabase.net/k926068/ 1993-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k926068-emitr-ii-barbiturate-assay-fda-510k.jpg K926068 - EMIT(R) II BARBITURATE ASSAY K926068 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jan 1993. https://www.510kdatabase.net/k914078/ 1993-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k914078-depuy-hip-prosthesis-fda-510k.jpg K914078 - DEPUY HIP PROSTHESIS K914078 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jan 1993. https://www.510kdatabase.net/k923367/ 1993-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k923367-cosgrove-edwards-annuloplasty-system-fda-510k.jpg K923367 - COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600 K923367 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jan 1993. https://www.510kdatabase.net/k924244/ 1993-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k924244-roche-reagent-for-ast-fda-510k.jpg K924244 - ROCHE REAGENT FOR AST K924244 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jan 1993. https://www.510kdatabase.net/k924832/ 1993-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k924832-olympus-creatine-kinase-reagent-fda-510k.jpg K924832 - OLYMPUS CREATINE KINASE REAGENT K924832 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Jan 1993. https://www.510kdatabase.net/k925002/ 1993-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k925002-urea-nitrogen-test-fda-510k.jpg K925002 - UREA NITROGEN TEST K925002 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jan 1993. https://www.510kdatabase.net/k925109/ 1993-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k925109-abbott-tdxtdxflx-tt4-fda-510k.jpg K925109 - ABBOTT TDX/TDXFLX TT4 K925109 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jan 1993. https://www.510kdatabase.net/k924719/ 1992-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k924719-ancor-fda-510k.jpg K924719 - ANCOR K924719 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Dec 1992. https://www.510kdatabase.net/k924756/ 1992-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k924756-mag-res-diag-devi-access-cir-polarcp-fda-510k.jpg K924756 - MAG RES DIAG DEVI ACCESS CIR POLAR(CP) SPINE COIL K924756 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Dec 1992. https://www.510kdatabase.net/k924006/ 1992-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k924006-bartel-prima-system-influenza-a-enzyme-fda-510k.jpg K924006 - BARTEL PRIMA SYSTEM INFLUENZA A ENZYME IMMUNOASSAY K924006 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Dec 1992. https://www.510kdatabase.net/k924659/ 1992-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k924659-olyumpus-total-protein-reagent-fda-510k.jpg K924659 - OLYUMPUS TOTAL PROTEIN REAGENT K924659 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Dec 1992. https://www.510kdatabase.net/k923959/ 1992-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k923959-albumin-test-fda-510k.jpg K923959 - ALBUMIN TEST K923959 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Dec 1992. https://www.510kdatabase.net/k924113/ 1992-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k924113-abuscreen-online-for-cocaine-metabolite-fda-510k.jpg K924113 - ABUSCREEN ONLINE FOR COCAINE METABOLITE K924113 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Dec 1992. https://www.510kdatabase.net/k925668/ 1992-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k925668-creatinine-meth-for-use-on-the-fda-510k.jpg K925668 - CREATININE METH FOR USE ON THE DIMENSION CLIN CHEM K925668 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Dec 1992. https://www.510kdatabase.net/k925801/ 1992-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k925801-rep-e-z-ck-30-isoenzyme-kit-fda-510k.jpg K925801 - REP E-Z CK-30 ISOENZYME KIT K925801 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Dec 1992. https://www.510kdatabase.net/k921653/ 1992-12-24 monthly 0.5 https://www.510kdatabase.net/og-image/k921653-vectra-magnetic-resonance-system-fda-510k.jpg K921653 - VECTRA MAGNETIC RESONANCE SYSTEM K921653 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Dec 1992. https://www.510kdatabase.net/k924479/ 1992-12-24 monthly 0.5 https://www.510kdatabase.net/og-image/k924479-magnetic-resonance-diagnostic-device-fda-510k.jpg K924479 - MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES K924479 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Dec 1992. https://www.510kdatabase.net/k915573/ 1992-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k915573-venous-reservoir-wcardiotomy-filter-fda-510k.jpg K915573 - VENOUS RESERVOIR W/CARDIOTOMY FILTER K915573 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Dec 1992. https://www.510kdatabase.net/k920684/ 1992-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k920684-new-tooth-material-fda-510k.jpg K920684 - NEW TOOTH MATERIAL K920684 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Dec 1992. https://www.510kdatabase.net/k923601/ 1992-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k923601-pancretec-provider-infusion-pump-fda-510k.jpg K923601 - PANCRETEC PROVIDER INFUSION PUMP -- MODIFICAITON K923601 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Dec 1992. https://www.510kdatabase.net/k925032/ 1992-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k925032-3m-vitremer-tri-cure-glass-ionomer-fda-510k.jpg K925032 - 3M VITREMER TRI-CURE GLASS IONOMER SYSTEM K925032 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Dec 1992. https://www.510kdatabase.net/k925495/ 1992-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k925495-microvasive-insurg-helical-mini-fda-510k.jpg K925495 - MICROVASIVE INSURG HELICAL & MINI-HELICAL BASKETS K925495 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Dec 1992. https://www.510kdatabase.net/k920891/ 1992-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k920891-roadrunnertm-wire-guide-modification-fda-510k.jpg K920891 - ROADRUNNER(TM) WIRE GUIDE, MODIFICATION K920891 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Dec 1992. https://www.510kdatabase.net/k923646/ 1992-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k923646-codman-endoflex-grasping-and-biopsy-fda-510k.jpg K923646 - CODMAN ENDOFLEX GRASPING AND BIOPSY FORCEPS K923646 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Dec 1992. https://www.510kdatabase.net/k924509/ 1992-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k924509-calcium-chloridediethylbarb-acetate-fda-510k.jpg K924509 - CALCIUM CHLORIDE/DIETHYLBARB ACETATE BUFF SOLUTION K924509 is a FDA 510(k) cleared hematology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Dec 1992. https://www.510kdatabase.net/k920154/ 1992-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k920154-bsm-8800a-bedside-monitor-fda-510k.jpg K920154 - BSM-8800A BEDSIDE MONITOR K920154 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Dec 1992. https://www.510kdatabase.net/k924426/ 1992-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k924426-magnetic-resonance-diag-device-access-fda-510k.jpg K924426 - MAGNETIC RESONANCE DIAG DEVICE ACCESS APPLIC PKG K924426 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Dec 1992. https://www.510kdatabase.net/k924691/ 1992-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k924691-olympus-iron-reagent-fda-510k.jpg K924691 - OLYMPUS IRON REAGENT K924691 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Dec 1992. https://www.510kdatabase.net/k924915/ 1992-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k924915-scale-set-solutions405nm-cat1480-650nm-fda-510k.jpg K924915 - SCALE SET SOLUTIONS/405NM CAT#1480-650NM CAT#1479 K924915 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Dec 1992. https://www.510kdatabase.net/k920802/ 1992-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k920802-alvine-total-ankle-fda-510k.jpg K920802 - ALVINE TOTAL ANKLE K920802 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Dec 1992. https://www.510kdatabase.net/k923786/ 1992-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k923786-polydoros-xs50-and-sx80-fda-510k.jpg K923786 - POLYDOROS XS50 AND SX80 K923786 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Dec 1992. https://www.510kdatabase.net/k924072/ 1992-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k924072-becton-dickinson-safety-lok-syringe-fda-510k.jpg K924072 - BECTON DICKINSON SAFETY-LOK SYRINGE K924072 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Dec 1992. https://www.510kdatabase.net/k924459/ 1992-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k924459-digiscan-2-fda-510k.jpg K924459 - DIGISCAN 2 K924459 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Dec 1992. https://www.510kdatabase.net/k924499/ 1992-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k924499-elite-test-strips-glucometer-fda-510k.jpg K924499 - ELITE TEST STRIPS GLUCOMETER K924499 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Dec 1992. https://www.510kdatabase.net/k925151/ 1992-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k925151-liquichek-ck-mb-control-levels-12-and3-fda-510k.jpg K925151 - LIQUICHEK CK-MB CONTROL LEVELS 1,2, AND3 K925151 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Dec 1992. https://www.510kdatabase.net/k925997/ 1992-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k925997-kodak-ektascan-sp-cassette-fda-510k.jpg K925997 - KODAK EKTASCAN SP CASSETTE K925997 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Dec 1992. https://www.510kdatabase.net/k926035/ 1992-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k926035-bard-leg-bag-holder-fda-510k.jpg K926035 - BARD LEG BAG HOLDER K926035 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 1992. https://www.510kdatabase.net/k911731/ 1992-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k911731-leucoprepr-brand-cell-separat-tube-fda-510k.jpg K911731 - LEUCOPREP(R) BRAND CELL SEPARAT TUBE W/SODIUM CITR K911731 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Dec 1992. https://www.510kdatabase.net/k920737/ 1992-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k920737-lifeshield-vial-adapter-fda-510k.jpg K920737 - LIFESHIELD VIAL ADAPTER K920737 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Dec 1992. https://www.510kdatabase.net/k924898/ 1992-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k924898-quanta-litetm-scl-70-elisa-fda-510k.jpg K924898 - QUANTA LITE(TM) SCL-70 ELISA K924898 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Dec 1992. https://www.510kdatabase.net/k920977/ 1992-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k920977-meritranstm-disposable-transducer-fda-510k.jpg K920977 - MERITRANS(TM) DISPOSABLE TRANSDUCER K920977 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Dec 1992. https://www.510kdatabase.net/k922458/ 1992-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k922458-dried-gram-negative-and-positive-fda-510k.jpg K922458 - DRIED GRAM-NEGATIVE AND POSITIVE MIC/COMBO PANELS K922458 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Dec 1992. https://www.510kdatabase.net/k925338/ 1992-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k925338-olympus-chloride-reagent-fda-510k.jpg K925338 - OLYMPUS CHLORIDE REAGENT K925338 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Dec 1992. https://www.510kdatabase.net/k924600/ 1992-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k924600-integral-drainageventricularlumbar-fda-510k.jpg K924600 - INTEGRAL DRAINAGE/VENTRICULAR/LUMBAR DRAINAGE SETS K924600 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cordis Corp.. Cleared Dec 1992. https://www.510kdatabase.net/k922541/ 1992-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k922541-usci-super-9-ptca-guiding-catheter-fda-510k.jpg K922541 - USCI SUPER 9 PTCA GUIDING CATHETER K922541 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 1992. https://www.510kdatabase.net/k922573/ 1992-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k922573-10-and-20-cc-inflationdeflation-fda-510k.jpg K922573 - 10 AND 20 CC INFLATION/DEFLATION DEVICES W/GAUGE K922573 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Dec 1992. https://www.510kdatabase.net/k920235/ 1992-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k920235-ultrasound-generator-modle-2270-fda-510k.jpg K920235 - ULTRASOUND GENERATOR MODLE 2270 K920235 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Dec 1992. https://www.510kdatabase.net/k920699/ 1992-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k920699-remstar-wtih-ramp-and-remote-fda-510k.jpg K920699 - REMSTAR WTIH RAMP AND REMOTE MODIFICATION K920699 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Dec 1992. https://www.510kdatabase.net/k920845/ 1992-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k920845-vigil-ii-fda-510k.jpg K920845 - VIGIL II K920845 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Dec 1992. https://www.510kdatabase.net/k922148/ 1992-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k922148-argyle-aero-jet-suction-catheter-fda-510k.jpg K922148 - ARGYLE AERO-JET SUCTION CATHETER K922148 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sherwood Medical Co.. Cleared Dec 1992. https://www.510kdatabase.net/k922974/ 1992-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k922974-portable-patient-monitor-fda-510k.jpg K922974 - PORTABLE PATIENT MONITOR K922974 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Dec 1992. https://www.510kdatabase.net/k923879/ 1992-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k923879-assay-software-for-dpc-marj5-alastat-fda-510k.jpg K923879 - ASSAY SOFTWARE FOR DPC-MARJ5 ALASTAT EIA SOFTWARE K923879 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Dec 1992. https://www.510kdatabase.net/k924552/ 1992-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k924552-du-pont-compact-daylight-system-ii-cds-fda-510k.jpg K924552 - DU PONT COMPACT DAYLIGHT SYSTEM II (CDS II) K924552 is a FDA 510(k) cleared radiology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Dec 1992. https://www.510kdatabase.net/k924478/ 1992-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k924478-mtv-250a-mtv-300a-fda-510k.jpg K924478 - MTV-250A, MTV-300A K924478 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Dec 1992. https://www.510kdatabase.net/k915736/ 1992-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k915736-medtronic-models-5069-and-5071-fda-510k.jpg K915736 - MEDTRONIC MODELS 5069 AND 5071 MYOCARDIAL PACING K915736 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Dec 1992. https://www.510kdatabase.net/k921254/ 1992-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k921254-blue-max-ii-balloon-ddilatation-catheter-fda-510k.jpg K921254 - BLUE MAX II BALLOON DDILATATION CATHETER K921254 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Dec 1992. https://www.510kdatabase.net/k924498/ 1992-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k924498-maxxus-fda-510k.jpg K924498 - MAXXUS K924498 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Dec 1992. https://www.510kdatabase.net/k924601/ 1992-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k924601-olympus-glucose-reagent-fda-510k.jpg K924601 - OLYMPUS GLUCOSE REAGENT K924601 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Dec 1992. https://www.510kdatabase.net/k924711/ 1992-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k924711-bicarbonate-fda-510k.jpg K924711 - BICARBONATE K924711 is a FDA 510(k) cleared hematology medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Dec 1992. https://www.510kdatabase.net/k924964/ 1992-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k924964-olympus-total-bilirubin-reagent-fda-510k.jpg K924964 - OLYMPUS TOTAL BILIRUBIN REAGENT K924964 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Dec 1992. https://www.510kdatabase.net/k925003/ 1992-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k925003-cobas-fp-reagent-for-valproic-acid-and-fda-510k.jpg K925003 - COBAS-FP REAGENT FOR VALPROIC ACID AND CALIBRATORS K925003 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Dec 1992. https://www.510kdatabase.net/k925060/ 1992-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k925060-remel-enoxacin-10-mcg-susceptibility-fda-510k.jpg K925060 - REMEL ENOXACIN 10 MCG SUSCEPTIBILITY DISK K925060 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Dec 1992. https://www.510kdatabase.net/k922222/ 1992-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k922222-angiographic-x-ray-system-fda-510k.jpg K922222 - ANGIOGRAPHIC X-RAY SYSTEM K922222 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Dec 1992. https://www.510kdatabase.net/k924124/ 1992-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k924124-behring-fibrintimer-a-fda-510k.jpg K924124 - BEHRING FIBRINTIMER A K924124 is a FDA 510(k) cleared hematology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Dec 1992. https://www.510kdatabase.net/k924394/ 1992-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k924394-clotting-factor-v-deficient-plasma-fda-510k.jpg K924394 - CLOTTING FACTOR V DEFICIENT PLASMA K924394 is a FDA 510(k) cleared hematology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Dec 1992. https://www.510kdatabase.net/k924395/ 1992-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k924395-neothromitinr-fda-510k.jpg K924395 - NEOTHROMITIN(R) K924395 is a FDA 510(k) cleared hematology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Dec 1992. https://www.510kdatabase.net/k924404/ 1992-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k924404-clibration-plasmas-fda-510k.jpg K924404 - CLIBRATION PLASMAS K924404 is a FDA 510(k) cleared hematology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Dec 1992. https://www.510kdatabase.net/k924405/ 1992-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k924405-control-plasma-p-fda-510k.jpg K924405 - CONTROL PLASMA P K924405 is a FDA 510(k) cleared hematology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Dec 1992. https://www.510kdatabase.net/k924846/ 1992-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k924846-remel-cefaclor-30mcg-susceptibility-disk-fda-510k.jpg K924846 - REMEL CEFACLOR 30MCG SUSCEPTIBILITY DISK K924846 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Nov 1992. https://www.510kdatabase.net/k924963/ 1992-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k924963-olympus-direct-bilirubin-reagent-fda-510k.jpg K924963 - OLYMPUS DIRECT BILIRUBIN REAGENT K924963 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Nov 1992. https://www.510kdatabase.net/k923025/ 1992-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k923025-signa-breast-coil-and-array-accessory-fda-510k.jpg K923025 - SIGNA BREAST COIL AND ARRAY ACCESSORY K923025 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Nov 1992. https://www.510kdatabase.net/k923107/ 1992-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k923107-body-band-restraint-strap-set-fda-510k.jpg K923107 - BODY BAND RESTRAINT STRAP SET K923107 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cook, Inc.. Cleared Nov 1992. https://www.510kdatabase.net/k923552/ 1992-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k923552-kodak-x-omat-fs-1a-processor-fda-510k.jpg K923552 - KODAK X-OMAT FS-1A PROCESSOR K923552 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Nov 1992. https://www.510kdatabase.net/k924349/ 1992-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k924349-general-purpose-flex-coil-catalog-fda-510k.jpg K924349 - GENERAL PURPOSE FLEX COIL, CATALOG NUMBER M1685GP K924349 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Nov 1992. https://www.510kdatabase.net/k910993/ 1992-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k910993-morrey-elbow-fixator-fda-510k.jpg K910993 - MORREY ELBOW FIXATOR K910993 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Nov 1992. https://www.510kdatabase.net/k922522/ 1992-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k922522-monoject-safety-syringe-1-cc-3cc-and-fda-510k.jpg K922522 - MONOJECT SAFETY SYRINGE, 1 CC, 3CC AND 12 CC SIZES K922522 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Nov 1992. https://www.510kdatabase.net/k924572/ 1992-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k924572-emds-glucose-glu-hk-test-item-65415-fda-510k.jpg K924572 - EMDS GLUCOSE (GLU-HK) TEST, ITEM 65415 K924572 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Nov 1992. https://www.510kdatabase.net/k924693/ 1992-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k924693-olympus-bun-reagent-fda-510k.jpg K924693 - OLYMPUS BUN REAGENT K924693 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Nov 1992. https://www.510kdatabase.net/k924812/ 1992-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k924812-3m-curing-light-xl-3000-fda-510k.jpg K924812 - 3M CURING LIGHT XL 3000 K924812 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Nov 1992. https://www.510kdatabase.net/k925203/ 1992-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k925203-technicon-chem-1rchem-1tm-software-ver-fda-510k.jpg K925203 - TECHNICON CHEM 1(R)/CHEM 1+(TM) SOFTWARE VER 11.1 K925203 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Nov 1992. https://www.510kdatabase.net/k920361/ 1992-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k920361-bard-biliary-balloon-dilators-fda-510k.jpg K920361 - BARD BILIARY BALLOON DILATORS K920361 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 1992. https://www.510kdatabase.net/k922905/ 1992-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k922905-fep-ringed-gore-tex-stretch-vascular-fda-510k.jpg K922905 - FEP RINGED GORE-TEX STRETCH VASCULAR GRAFT K922905 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Nov 1992. https://www.510kdatabase.net/k922182/ 1992-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k922182-unipolar-atrial-temporary-pacing-lead-fda-510k.jpg K922182 - UNIPOLAR ATRIAL TEMPORARY PACING LEAD, MODEL 6492 K922182 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Nov 1992. https://www.510kdatabase.net/k922268/ 1992-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k922268-unipolar-pediatric-temporary-pacing-fda-510k.jpg K922268 - UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD MOD. 6491 K922268 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Nov 1992. https://www.510kdatabase.net/k922467/ 1992-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k922467-synchron-total-protein-test-modified-fda-510k.jpg K922467 - SYNCHRON TOTAL PROTEIN TEST --MODIFIED K922467 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Nov 1992. https://www.510kdatabase.net/k924004/ 1992-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k924004-seidel-humeral-locking-nail-additional-fda-510k.jpg K924004 - SEIDEL HUMERAL LOCKING NAIL -- ADDITIONAL LENGTHS K924004 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Nov 1992. https://www.510kdatabase.net/k924202/ 1992-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k924202-radifocusr-catheter-guide-wire-fda-510k.jpg K924202 - RADIFOCUS(R) (CATHETER) GUIDE WIRE K924202 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Nov 1992. https://www.510kdatabase.net/k925057/ 1992-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k925057-olympus-inorganic-phosphorus-reagent-fda-510k.jpg K925057 - OLYMPUS INORGANIC PHOSPHORUS REAGENT K925057 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Nov 1992. https://www.510kdatabase.net/k922231/ 1992-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k922231-olympus-cholesterol-reagent-fda-510k.jpg K922231 - OLYMPUS CHOLESTEROL REAGENT K922231 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Nov 1992. https://www.510kdatabase.net/k922610/ 1992-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k922610-balloon-dilatation-catheter-fda-510k.jpg K922610 - BALLOON DILATATION CATHETER K922610 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Nov 1992. https://www.510kdatabase.net/k924246/ 1992-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k924246-roche-reagent-for-ggt-fda-510k.jpg K924246 - ROCHE REAGENT FOR GGT K924246 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Nov 1992. https://www.510kdatabase.net/k925156/ 1992-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k925156-olympus-alkaline-phosphatase-reagent-fda-510k.jpg K925156 - OLYMPUS ALKALINE PHOSPHATASE REAGENT K925156 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Nov 1992. https://www.510kdatabase.net/k922105/ 1992-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k922105-usci-linx-ez-guide-wire-exten-w-propel-fda-510k.jpg K922105 - USCI LINX EZ GUIDE WIRE EXTEN. W/ PRO/PEL COATING K922105 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 1992. https://www.510kdatabase.net/k923979/ 1992-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k923979-lc-tray-material-fda-510k.jpg K923979 - LC TRAY MATERIAL K923979 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Nov 1992. https://www.510kdatabase.net/k924024/ 1992-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k924024-ortho-wax-fda-510k.jpg K924024 - ORTHO WAX K924024 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Nov 1992. https://www.510kdatabase.net/k922934/ 1992-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k922934-enzygnost-f-12-fda-510k.jpg K922934 - ENZYGNOST F 1+2 K922934 is a FDA 510(k) cleared hematology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Nov 1992. https://www.510kdatabase.net/k923572/ 1992-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k923572-vista-free-thyroxine-assay-fda-510k.jpg K923572 - VISTA FREE THYROXINE ASSAY K923572 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Nov 1992. https://www.510kdatabase.net/k924393/ 1992-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k924393-standard-human-plasma-fda-510k.jpg K924393 - STANDARD HUMAN PLASMA K924393 is a FDA 510(k) cleared hematology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Nov 1992. https://www.510kdatabase.net/k924965/ 1992-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k924965-olympus-lactate-dehydrogenase-reagent-fda-510k.jpg K924965 - OLYMPUS LACTATE DEHYDROGENASE REAGENT K924965 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Nov 1992. https://www.510kdatabase.net/k924276/ 1992-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k924276-short-tegwire-modified-fda-510k.jpg K924276 - SHORT TEGWIRE -- MODIFIED K924276 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Nov 1992. https://www.510kdatabase.net/k913890/ 1992-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k913890-sonicathtm-35-f-20-mhz-fda-510k.jpg K913890 - SONICATH(TM) 3.5 F, 20 MHZ K913890 is a FDA 510(k) cleared radiology medical device. Manufacturer: Boston Scientific Corp. Cleared Nov 1992. https://www.510kdatabase.net/k921194/ 1992-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k921194-hewlett-packard-cardiac-fda-510k.jpg K921194 - HEWLETT-PACKARD CARDIAC CATHETERIZATION RECORDING K921194 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Nov 1992. https://www.510kdatabase.net/k921941/ 1992-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k921941-signa-advantage-05t-mag-reson-sys-fast-fda-510k.jpg K921941 - SIGNA ADVANTAGE 0.5T MAG RESON SYS-FAST ACQUIS OPT K921941 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Nov 1992. https://www.510kdatabase.net/k923042/ 1992-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k923042-du-pont-linx-hd-25-lasr-imager-fda-510k.jpg K923042 - DU PONT LINX HD-25 LASR IMAGER K923042 is a FDA 510(k) cleared radiology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Nov 1992. https://www.510kdatabase.net/k924241/ 1992-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k924241-argenco-75m-fda-510k.jpg K924241 - ARGENCO 75M K924241 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Nov 1992. https://www.510kdatabase.net/k924574/ 1992-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k924574-emds-alkaline-phosphatase-alp-test-fda-510k.jpg K924574 - EMDS ALKALINE PHOSPHATASE (ALP) TEST K924574 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Nov 1992. https://www.510kdatabase.net/k924471/ 1992-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k924471-kodak-ektachem-clinical-chemistry-fda-510k.jpg K924471 - KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (NAIL) K924471 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Nov 1992. https://www.510kdatabase.net/k924573/ 1992-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k924573-systemate-plus-triglyceride-glycerol-fda-510k.jpg K924573 - SYSTEMATE PLUS TRIGLYCERIDE-GLYCEROL BLANKED TEST K924573 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Nov 1992. https://www.510kdatabase.net/k913982/ 1992-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k913982-lifeshield-anesthesia-set-fda-510k.jpg K913982 - LIFESHIELD ANESTHESIA SET K913982 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1992. https://www.510kdatabase.net/k923567/ 1992-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k923567-medtronic-model-3888-pisces-quad-plus-fda-510k.jpg K923567 - MEDTRONIC MODEL 3888 PISCES-QUAD PLUS LEAD K923567 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Nov 1992. https://www.510kdatabase.net/k915641/ 1992-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k915641-zirconia-ceramic-modular-head-9type-ii-fda-510k.jpg K915641 - ZIRCONIA CERAMIC MODULAR HEAD 9TYPE II TAPER K915641 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Nov 1992. https://www.510kdatabase.net/k924422/ 1992-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k924422-palabond-fda-510k.jpg K924422 - PALABOND K924422 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Nov 1992. https://www.510kdatabase.net/k923566/ 1992-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k923566-nizyme-test-kit-fda-510k.jpg K923566 - NIZYME TEST KIT K923566 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Nov 1992. https://www.510kdatabase.net/k923658/ 1992-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k923658-rep-immunofix-fda-510k.jpg K923658 - REP IMMUNOFIX K923658 is a FDA 510(k) cleared immunology medical device. Manufacturer: Helena Laboratories. Cleared Nov 1992. https://www.510kdatabase.net/k923873/ 1992-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k923873-syva-emit-ii-propoxyphene-assay-fda-510k.jpg K923873 - SYVA EMIT II PROPOXYPHENE ASSAY K923873 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Nov 1992. https://www.510kdatabase.net/k924047/ 1992-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k924047-sub-4-small-vessel-balloon-dilatation-fda-510k.jpg K924047 - SUB-4 SMALL VESSEL BALLOON DILATATION CATHETER K924047 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Nov 1992. https://www.510kdatabase.net/k924797/ 1992-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k924797-cefpodoxime-10-mcg-sensi-disc-fda-510k.jpg K924797 - CEFPODOXIME 10 MCG, SENSI DISC K924797 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Nov 1992. https://www.510kdatabase.net/k921936/ 1992-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k921936-cordis-polypropylene-straight-t-y-fda-510k.jpg K921936 - CORDIS POLYPROPYLENE STRAIGHT, T & Y CONNECTOR K921936 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cordis Corp.. Cleared Oct 1992. https://www.510kdatabase.net/k922086/ 1992-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k922086-bard-biopsy-forceps-fda-510k.jpg K922086 - BARD BIOPSY FORCEPS K922086 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 1992. https://www.510kdatabase.net/k923616/ 1992-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k923616-omniflex-c-uhmwpe-mid-shaft-restrictor-fda-510k.jpg K923616 - OMNIFLEX-C UHMWPE MID-SHAFT RESTRICTOR K923616 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Oct 1992. https://www.510kdatabase.net/k915807/ 1992-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k915807-eudermic-powder-free-surgical-gloves-fda-510k.jpg K915807 - EUDERMIC POWDER-FREE SURGICAL GLOVES K915807 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1992. https://www.510kdatabase.net/k921243/ 1992-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k921243-convertors-sterilization-wrap-fda-510k.jpg K921243 - CONVERTORS STERILIZATION WRAP K921243 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Oct 1992. https://www.510kdatabase.net/k921804/ 1992-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k921804-dextron-surgical-gloves-fda-510k.jpg K921804 - DEXTRON SURGICAL GLOVES K921804 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1992. https://www.510kdatabase.net/k924694/ 1992-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k924694-lipase-hydrolysisglycerot-kinase-fda-510k.jpg K924694 - LIPASE HYDROLYSIS/GLYCEROT KINASE ENZYME, TRIGLYC K924694 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Oct 1992. https://www.510kdatabase.net/k923851/ 1992-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k923851-acqsim-simulatorlocalizer-fda-510k.jpg K923851 - ACQSIM SIMULATOR/LOCALIZER K923851 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Oct 1992. https://www.510kdatabase.net/k922713/ 1992-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k922713-kodak-amerlite-mab-ft3-assay-fda-510k.jpg K922713 - KODAK AMERLITE MAB FT3 ASSAY K922713 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Oct 1992. https://www.510kdatabase.net/k922844/ 1992-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k922844-beckman-valproic-acid-reagent-fda-510k.jpg K922844 - BECKMAN VALPROIC ACID REAGENT K922844 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Oct 1992. https://www.510kdatabase.net/k923080/ 1992-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k923080-il-test-apoliporotein-b-apo-b-fda-510k.jpg K923080 - IL TEST APOLIPOROTEIN B (APO B) K923080 is a FDA 510(k) cleared immunology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Oct 1992. https://www.510kdatabase.net/k923087/ 1992-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k923087-il-test-apolipoprotein-a1-fda-510k.jpg K923087 - IL TEST APOLIPOPROTEIN A1 K923087 is a FDA 510(k) cleared immunology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Oct 1992. https://www.510kdatabase.net/k923134/ 1992-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k923134-cordis-steerable-guidewire-fda-510k.jpg K923134 - CORDIS STEERABLE GUIDEWIRE K923134 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Oct 1992. https://www.510kdatabase.net/k923639/ 1992-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k923639-diamond-coated-dental-inserts-fda-510k.jpg K923639 - DIAMOND COATED DENTAL INSERTS K923639 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Oct 1992. https://www.510kdatabase.net/k923641/ 1992-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k923641-il-test-ast-pn-35312-fda-510k.jpg K923641 - IL TEST AST, PN 35312 K923641 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Oct 1992. https://www.510kdatabase.net/k923733/ 1992-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k923733-cholesterol-test-fda-510k.jpg K923733 - CHOLESTEROL TEST K923733 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Oct 1992. https://www.510kdatabase.net/k923921/ 1992-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k923921-il-test-pt-fibrinogen-hs-fda-510k.jpg K923921 - IL TEST PT FIBRINOGEN HS K923921 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Oct 1992. https://www.510kdatabase.net/k924765/ 1992-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k924765-remel-lomefloxacin-10-mcg-fda-510k.jpg K924765 - REMEL LOMEFLOXACIN 10 MCG SUSCEPTIBILITY DISK K924765 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Oct 1992. https://www.510kdatabase.net/k924766/ 1992-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k924766-remel-ofloxacin-5mcg-susceptibility-disk-fda-510k.jpg K924766 - REMEL OFLOXACIN 5MCG SUSCEPTIBILITY DISK K924766 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Oct 1992. https://www.510kdatabase.net/k913893/ 1992-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k913893-resisttm-orthopaedic-surgical-glove-fda-510k.jpg K913893 - RESIST(TM) ORTHOPAEDIC SURGICAL GLOVE K913893 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Depuy, Inc.. Cleared Oct 1992. https://www.510kdatabase.net/k924245/ 1992-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k924245-roche-reagent-for-alt-fda-510k.jpg K924245 - ROCHE REAGENT FOR ALT K924245 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Oct 1992. https://www.510kdatabase.net/k915138/ 1992-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k915138-ge-sonochrome-fda-510k.jpg K915138 - GE SONOCHROME K915138 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Oct 1992. https://www.510kdatabase.net/k915396/ 1992-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k915396-osteonics-zirconia-c-taper-femoral-fda-510k.jpg K915396 - OSTEONICS ZIRCONIA C-TAPER FEMORAL BEARING HEAD K915396 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Oct 1992. https://www.510kdatabase.net/k921192/ 1992-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k921192-ct-sytec-6000-computed-tomography-system-fda-510k.jpg K921192 - CT SYTEC 6000 COMPUTED TOMOGRAPHY SYSTEM K921192 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Oct 1992. https://www.510kdatabase.net/k923451/ 1992-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k923451-amk-modular-porous-coated-titanium-fda-510k.jpg K923451 - AMK MODULAR POROUS COATED TITANIUM TIBIAL TRAY K923451 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Oct 1992. https://www.510kdatabase.net/k920774/ 1992-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k920774-mvr-collapsible-venous-reservoir-bag-fda-510k.jpg K920774 - MVR COLLAPSIBLE VENOUS RESERVOIR BAG K920774 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Oct 1992. https://www.510kdatabase.net/k922558/ 1992-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k922558-interlinktm-injection-site-fda-510k.jpg K922558 - INTERLINK(TM) INJECTION SITE K922558 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Oct 1992. https://www.510kdatabase.net/k923407/ 1992-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k923407-medtronic-models-5455l-and-5455sl-fda-510k.jpg K923407 - MEDTRONIC MODELS 5455L AND 5455SL SURGICAL CABLES K923407 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Oct 1992. https://www.510kdatabase.net/k924339/ 1992-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k924339-olympus-amylase-reagent-fda-510k.jpg K924339 - OLYMPUS AMYLASE REAGENT K924339 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Oct 1992. https://www.510kdatabase.net/k924435/ 1992-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k924435-olympus-calcium-reagent-fda-510k.jpg K924435 - OLYMPUS CALCIUM REAGENT K924435 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Oct 1992. https://www.510kdatabase.net/k924658/ 1992-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k924658-olympus-magnesium-reagent-fda-510k.jpg K924658 - OLYMPUS MAGNESIUM REAGENT K924658 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Oct 1992. https://www.510kdatabase.net/k924692/ 1992-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k924692-olympus-creatinine-reagent-fda-510k.jpg K924692 - OLYMPUS CREATININE REAGENT K924692 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Oct 1992. https://www.510kdatabase.net/k920824/ 1992-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k920824-roadrunner-rltf-guide-wire-fda-510k.jpg K920824 - ROADRUNNER RLTF GUIDE WIRE K920824 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Oct 1992. https://www.510kdatabase.net/k921823/ 1992-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k921823-arthrex-arthroscopy-ice-blade-fda-510k.jpg K921823 - ARTHREX ARTHROSCOPY ICE BLADE K921823 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Oct 1992. https://www.510kdatabase.net/k923571/ 1992-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k923571-vista-triiodothyronine-assay-fda-510k.jpg K923571 - VISTA TRIIODOTHYRONINE ASSAY K923571 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Oct 1992. https://www.510kdatabase.net/k924599/ 1992-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k924599-creatinine-ip-test-4237593-42323r1-fda-510k.jpg K924599 - CREATININE-IP TEST, # 42375/93, 42323/R1, 42323/R2 K924599 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Oct 1992. https://www.510kdatabase.net/k921526/ 1992-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k921526-datascope-passport-monitor-with-co2-fda-510k.jpg K921526 - DATASCOPE PASSPORT MONITOR WITH CO2 K921526 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Datascope Corp.. Cleared Oct 1992. https://www.510kdatabase.net/k922771/ 1992-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k922771-kodak-amerlex-mab-ft3-assay-fda-510k.jpg K922771 - KODAK AMERLEX MAB FT3 ASSAY K922771 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Oct 1992. https://www.510kdatabase.net/k922945/ 1992-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k922945-technicon-dax-system-thyroxine-t4-method-fda-510k.jpg K922945 - TECHNICON DAX SYSTEM THYROXINE (T4) METHOD K922945 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Oct 1992. https://www.510kdatabase.net/k923048/ 1992-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k923048-accu-chek-easy-blood-glucose-system-fda-510k.jpg K923048 - ACCU-CHEK EASY BLOOD GLUCOSE SYSTEM K923048 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Oct 1992. https://www.510kdatabase.net/k924470/ 1992-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k924470-two-part-inorganic-phosphorus-test-fda-510k.jpg K924470 - TWO PART INORGANIC PHOSPHORUS TEST K924470 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Oct 1992. https://www.510kdatabase.net/k924475/ 1992-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k924475-accudata-glucose-test-station-fda-510k.jpg K924475 - ACCUDATA GLUCOSE TEST STATION K924475 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Oct 1992. https://www.510kdatabase.net/k924704/ 1992-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k924704-creatine-kinase-ck-test-item-65411-fda-510k.jpg K924704 - CREATINE KINASE (CK) TEST ITEM #65411 K924704 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Oct 1992. https://www.510kdatabase.net/k923615/ 1992-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k923615-vista-hpq-system-fda-510k.jpg K923615 - VISTA HPQ SYSTEM K923615 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Oct 1992. https://www.510kdatabase.net/k923676/ 1992-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k923676-vista-thyroxine-uptake-assay-fda-510k.jpg K923676 - VISTA THYROXINE UPTAKE ASSAY K923676 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Oct 1992. https://www.510kdatabase.net/k923545/ 1992-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k923545-bard-7-fr-fiber-optic-assembly-fda-510k.jpg K923545 - BARD 7 FR. FIBER OPTIC ASSEMBLY K923545 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 1992. https://www.510kdatabase.net/k922058/ 1992-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k922058-models-m1175a-and-m1176a-component-fda-510k.jpg K922058 - MODELS M1175A AND M1176A COMPONENT MONITORING SYST K922058 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Oct 1992. https://www.510kdatabase.net/k923578/ 1992-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k923578-liquichek-rheumatoid-factor-control-fda-510k.jpg K923578 - LIQUICHEK RHEUMATOID FACTOR CONTROL K923578 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Oct 1992. https://www.510kdatabase.net/k923700/ 1992-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k923700-indoxyl-acetate-disk-fda-510k.jpg K923700 - INDOXYL ACETATE DISK K923700 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Oct 1992. https://www.510kdatabase.net/k923346/ 1992-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k923346-olympus-amylase-reagent-fda-510k.jpg K923346 - OLYMPUS AMYLASE REAGENT K923346 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Oct 1992. https://www.510kdatabase.net/k923607/ 1992-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k923607-radifocus-guide-wire-m-fda-510k.jpg K923607 - RADIFOCUS GUIDE WIRE M K923607 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Terumo Medical Corp.. Cleared Oct 1992. https://www.510kdatabase.net/k923609/ 1992-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k923609-olympus-total-bilirubin-reagent-fda-510k.jpg K923609 - OLYMPUS TOTAL BILIRUBIN REAGENT K923609 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Oct 1992. https://www.510kdatabase.net/k923610/ 1992-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k923610-olympus-chloride-reagent-fda-510k.jpg K923610 - OLYMPUS CHLORIDE REAGENT K923610 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Oct 1992. https://www.510kdatabase.net/k921014/ 1992-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k921014-model-m2350a-and-m2360a-wavevue-fda-510k.jpg K921014 - MODEL M2350A AND M2360A WAVEVUE CENTRAL MONITOR K921014 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Oct 1992. https://www.510kdatabase.net/k921747/ 1992-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k921747-micro-trak-xl-system-fda-510k.jpg K921747 - MICRO TRAK XL SYSTEM K921747 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Syva Co.. Cleared Oct 1992. https://www.510kdatabase.net/k922532/ 1992-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k922532-il-test-glucose-pn-181633-80-fda-510k.jpg K922532 - IL TEST GLUCOSE, PN 181633-80 K922532 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 1992. https://www.510kdatabase.net/k923264/ 1992-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k923264-general-purpose-flex-coil-fda-510k.jpg K923264 - GENERAL PURPOSE FLEX COIL K923264 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Sep 1992. https://www.510kdatabase.net/k915331/ 1992-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k915331-auto-suture-surgiport-disposable-fda-510k.jpg K915331 - AUTO SUTURE SURGIPORT DISPOSABLE ANCHORING DEVICE K915331 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Sep 1992. https://www.510kdatabase.net/k921831/ 1992-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k921831-imxr-glycated-hemoglobin-fda-510k.jpg K921831 - IMX(R) GLYCATED HEMOGLOBIN K921831 is a FDA 510(k) cleared hematology medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1992. https://www.510kdatabase.net/k922351/ 1992-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k922351-quanta-litetm-iga-aca-fda-510k.jpg K922351 - QUANTA LITE(TM) IGA ACA K922351 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Sep 1992. https://www.510kdatabase.net/k923309/ 1992-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k923309-argus-pet-system-fda-510k.jpg K923309 - ARGUS PET SYSTEM K923309 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Sep 1992. https://www.510kdatabase.net/k923549/ 1992-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k923549-paladisc-lc-fda-510k.jpg K923549 - PALADISC LC K923549 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Sep 1992. https://www.510kdatabase.net/k923586/ 1992-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k923586-burnout-material-fda-510k.jpg K923586 - BURNOUT MATERIAL K923586 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Sep 1992. https://www.510kdatabase.net/k915338/ 1992-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k915338-conductive-surgigrip-spiral-sleeve-fda-510k.jpg K915338 - CONDUCTIVE SURGIGRIP SPIRAL SLEEVE K915338 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Sep 1992. https://www.510kdatabase.net/k921270/ 1992-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k921270-safe-dwell-plus-central-venous-catheter-fda-510k.jpg K921270 - SAFE-DWELL PLUS CENTRAL VENOUS CATHETER K921270 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1992. https://www.510kdatabase.net/k921863/ 1992-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k921863-sonos-500-1000-1500sonos-or-ultrasound-fda-510k.jpg K921863 - SONOS 500, 1000, 1500/SONOS OR ULTRASOUND IMAG SYS K921863 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Sep 1992. https://www.510kdatabase.net/k922947/ 1992-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k922947-gamma-gultamyl-transferase-test-fda-510k.jpg K922947 - GAMMA GULTAMYL TRANSFERASE TEST K922947 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Sep 1992. https://www.510kdatabase.net/k923105/ 1992-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k923105-miles-urine-amylase-method-fda-510k.jpg K923105 - MILES URINE AMYLASE METHOD K923105 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Sep 1992. https://www.510kdatabase.net/k923257/ 1992-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k923257-emds-alanine-aminotransfer-testalt-fda-510k.jpg K923257 - EMDS ALANINE AMINOTRANSFER TEST(ALT) TECH RA 1000 K923257 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Sep 1992. https://www.510kdatabase.net/k923320/ 1992-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k923320-quanta-lite-aca-screen-fda-510k.jpg K923320 - QUANTA LITE ACA SCREEN K923320 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Sep 1992. https://www.510kdatabase.net/k923527/ 1992-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k923527-olympus-alkaline-phosphatase-reagent-fda-510k.jpg K923527 - OLYMPUS ALKALINE PHOSPHATASE REAGENT K923527 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Sep 1992. https://www.510kdatabase.net/k923565/ 1992-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k923565-olympus-iron-reagent-fda-510k.jpg K923565 - OLYMPUS IRON REAGENT K923565 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Sep 1992. https://www.510kdatabase.net/k923682/ 1992-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k923682-model-m1032a-vuelink-interface-plug-in-fda-510k.jpg K923682 - MODEL M1032A VUELINK INTERFACE PLUG-IN MODULE K923682 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Sep 1992. https://www.510kdatabase.net/k923827/ 1992-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k923827-lap-disk-fda-510k.jpg K923827 - LAP DISK K923827 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Sep 1992. https://www.510kdatabase.net/k920503/ 1992-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k920503-syva-microtrak-chlamydia-eia-fda-510k.jpg K920503 - SYVA MICROTRAK CHLAMYDIA EIA K920503 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Syva Co.. Cleared Sep 1992. https://www.510kdatabase.net/k921462/ 1992-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k921462-microtrakr-ii-chlamydia-eia-assay-fda-510k.jpg K921462 - MICROTRAK(R) II CHLAMYDIA EIA ASSAY K921462 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Syva Co.. Cleared Sep 1992. https://www.510kdatabase.net/k923740/ 1992-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k923740-kodak-amerlite-total-thyroid-control-fda-510k.jpg K923740 - KODAK AMERLITE TOTAL THYROID CONTROL SERA K923740 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Sep 1992. https://www.510kdatabase.net/k921578/ 1992-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k921578-titan-gel-alkaline-phosphatase-hr-fda-510k.jpg K921578 - TITAN GEL ALKALINE PHOSPHATASE (HR) K921578 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Sep 1992. https://www.510kdatabase.net/k922699/ 1992-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k922699-du-pont-aca-mass-creative-kinase-mb-fda-510k.jpg K922699 - DU PONT ACA MASS CREATIVE KINASE MB (MCKMB) CALIBR K922699 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Sep 1992. https://www.510kdatabase.net/k923018/ 1992-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k923018-encore-test-strips-fda-510k.jpg K923018 - ENCORE TEST STRIPS K923018 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Sep 1992. https://www.510kdatabase.net/k923108/ 1992-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k923108-wrist-restraint-for-ge9800-ct-tables-fda-510k.jpg K923108 - WRIST RESTRAINT FOR GE9800 C.T. TABLES K923108 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cook, Inc.. Cleared Sep 1992. https://www.510kdatabase.net/k923109/ 1992-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k923109-adult-chin-strap-for-ct-tables-fda-510k.jpg K923109 - ADULT CHIN STRAP FOR CT TABLES K923109 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cook, Inc.. Cleared Sep 1992. https://www.510kdatabase.net/k923110/ 1992-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k923110-scan-band-fda-510k.jpg K923110 - SCAN BAND K923110 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cook, Inc.. Cleared Sep 1992. https://www.510kdatabase.net/k923111/ 1992-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k923111-arm-extender-for-ct-tables-fda-510k.jpg K923111 - ARM EXTENDER FOR CT TABLES K923111 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cook, Inc.. Cleared Sep 1992. https://www.510kdatabase.net/k923112/ 1992-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k923112-angio-band-fda-510k.jpg K923112 - ANGIO-BAND K923112 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cook, Inc.. Cleared Sep 1992. https://www.510kdatabase.net/k923114/ 1992-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k923114-head-restraint-for-ct-tables-fda-510k.jpg K923114 - HEAD RESTRAINT FOR CT TABLES K923114 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cook, Inc.. Cleared Sep 1992. https://www.510kdatabase.net/k923240/ 1992-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k923240-baxter-sensor-coronary-guidewire-fda-510k.jpg K923240 - BAXTER SENSOR CORONARY GUIDEWIRE K923240 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Sep 1992. https://www.510kdatabase.net/k923258/ 1992-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k923258-technicon-immuno-1-system-total-fda-510k.jpg K923258 - TECHNICON IMMUNO 1 SYSTEM TOTAL TRIIODOTHYRONINE K923258 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Sep 1992. https://www.510kdatabase.net/k922525/ 1992-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k922525-dall-miles-broad-bone-plate-fda-510k.jpg K922525 - DALL MILES BROAD BONE PLATE K922525 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Sep 1992. https://www.510kdatabase.net/k923037/ 1992-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k923037-miles-sodium-method-fda-510k.jpg K923037 - MILES SODIUM METHOD K923037 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Sep 1992. https://www.510kdatabase.net/k923121/ 1992-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k923121-qbc-hemacan-hematology-system-fda-510k.jpg K923121 - QBC HEMACAN HEMATOLOGY SYSTEM K923121 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1992. https://www.510kdatabase.net/k923764/ 1992-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k923764-systemate-phosphorus-test-technicon-ra-fda-510k.jpg K923764 - SYSTEMATE PHOSPHORUS TEST TECHNICON RA 1000 K923764 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Sep 1992. https://www.510kdatabase.net/k923765/ 1992-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k923765-systemate-uricacid-test-technicon-ra-fda-510k.jpg K923765 - SYSTEMATE URICACID TEST, TECHNICON RA 1000 K923765 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Sep 1992. https://www.510kdatabase.net/k924129/ 1992-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k924129-miles-auto-meth-determin-of-uric-acid-fda-510k.jpg K924129 - MILES AUTO METH DETERMIN OF URIC ACID IN URINE K924129 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Sep 1992. https://www.510kdatabase.net/k915726/ 1992-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k915726-pulmonary-artery-flow-directed-fda-510k.jpg K915726 - PULMONARY ARTERY FLOW-DIRECTED THERMODILUTION CATH K915726 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Sep 1992. https://www.510kdatabase.net/k921702/ 1992-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k921702-meri-dapttm-hemostasis-valvetorqloc-fda-510k.jpg K921702 - MERI-DAPT(TM) HEMOSTASIS VALVE/TORQLOC TORQUE DEVI K921702 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Sep 1992. https://www.510kdatabase.net/k921833/ 1992-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k921833-endopath-endo-surgery-percutaneous-fda-510k.jpg K921833 - ENDOPATH ENDO-SURGERY PERCUTANEOUS CATHETER INTROD K921833 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Ethicon, Inc.. Cleared Sep 1992. https://www.510kdatabase.net/k922266/ 1992-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k922266-alta-femoral-intramedullary-rod-system-fda-510k.jpg K922266 - ALTA FEMORAL INTRAMEDULLARY ROD SYSTEM, ADD SIZES K922266 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Sep 1992. https://www.510kdatabase.net/k922503/ 1992-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k922503-howmedicar-hnr-system-fda-510k.jpg K922503 - HOWMEDICA(R) HNR SYSTEM K922503 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Sep 1992. https://www.510kdatabase.net/k922433/ 1992-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k922433-vista-thyroxine-t-4-assay-modification-fda-510k.jpg K922433 - VISTA THYROXINE (T-4) ASSAY -- MODIFICATION K922433 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Sep 1992. https://www.510kdatabase.net/k922829/ 1992-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k922829-quanta-lite-ena-elisa-fda-510k.jpg K922829 - QUANTA LITE ENA ELISA K922829 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Sep 1992. https://www.510kdatabase.net/k922830/ 1992-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k922830-quanta-lite-ss-a-elisa-fda-510k.jpg K922830 - QUANTA LITE SS-A ELISA K922830 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Sep 1992. https://www.510kdatabase.net/k922831/ 1992-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k922831-quanta-lite-sm-elisa-fda-510k.jpg K922831 - QUANTA LITE SM ELISA K922831 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Sep 1992. https://www.510kdatabase.net/k922832/ 1992-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k922832-quanta-lite-ss-b-elisa-fda-510k.jpg K922832 - QUANTA LITE SS-B ELISA K922832 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Sep 1992. https://www.510kdatabase.net/k922833/ 1992-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k922833-quanta-lite-rnp-elisa-fda-510k.jpg K922833 - QUANTA LITE RNP ELISA K922833 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Sep 1992. https://www.510kdatabase.net/k923412/ 1992-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k923412-olympus-lactate-dehydrogenase-reagent-fda-510k.jpg K923412 - OLYMPUS LACTATE DEHYDROGENASE REAGENT K923412 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Sep 1992. https://www.510kdatabase.net/k923526/ 1992-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k923526-olympus-creatinine-reagent-fda-510k.jpg K923526 - OLYMPUS CREATININE REAGENT K923526 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Sep 1992. https://www.510kdatabase.net/k920068/ 1992-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k920068-auto-suture-endoscopic-mini-retractor-fda-510k.jpg K920068 - AUTO SUTURE ENDOSCOPIC MINI-RETRACTOR K920068 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Sep 1992. https://www.510kdatabase.net/k921310/ 1992-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k921310-cordis-6-french-paragon-angiographic-fda-510k.jpg K921310 - CORDIS 6 FRENCH PARAGON ANGIOGRAPHIC CATHETER K921310 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Sep 1992. https://www.510kdatabase.net/k923623/ 1992-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k923623-il-test-alt-pn-35311-fda-510k.jpg K923623 - IL TEST ALT, PN 35311 K923623 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 1992. https://www.510kdatabase.net/k915898/ 1992-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k915898-paladur-fda-510k.jpg K915898 - PALADUR K915898 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Sep 1992. https://www.510kdatabase.net/k920889/ 1992-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k920889-minimaxrmaximar-hollow-fiber-oxygenators-fda-510k.jpg K920889 - MINIMAX(R)/MAXIMA(R) HOLLOW FIBER OXYGENATORS K920889 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Sep 1992. https://www.510kdatabase.net/k922272/ 1992-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k922272-yasargil-aneurysm-clips-fda-510k.jpg K922272 - YASARGIL ANEURYSM CLIPS K922272 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Sep 1992. https://www.510kdatabase.net/k923034/ 1992-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k923034-miles-urine-calcium-method-fda-510k.jpg K923034 - MILES URINE CALCIUM METHOD K923034 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Sep 1992. https://www.510kdatabase.net/k923040/ 1992-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k923040-miles-urine-glucose-method-fda-510k.jpg K923040 - MILES URINE GLUCOSE METHOD K923040 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Sep 1992. https://www.510kdatabase.net/k923049/ 1992-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k923049-uroskop-d1-uroskop-d2-and-uroskop-d3-fda-510k.jpg K923049 - UROSKOP D1, UROSKOP D2, AND UROSKOP D3 K923049 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 1992. https://www.510kdatabase.net/k923285/ 1992-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k923285-pro-tip-disposable-31-syringe-nozzle-fda-510k.jpg K923285 - PRO-TIP DISPOSABLE 3/1 SYRINGE NOZZLE K923285 is a FDA 510(k) cleared dental medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Sep 1992. https://www.510kdatabase.net/k922483/ 1992-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k922483-du-pont-compact-daylight-system-2000-fda-510k.jpg K922483 - DU PONT COMPACT DAYLIGHT SYSTEM 2000 K922483 is a FDA 510(k) cleared radiology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Sep 1992. https://www.510kdatabase.net/k922588/ 1992-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k922588-roche-enterotube-ii-fda-510k.jpg K922588 - ROCHE ENTEROTUBE II K922588 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Sep 1992. https://www.510kdatabase.net/k923106/ 1992-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k923106-scan-band-fda-510k.jpg K923106 - SCAN BAND K923106 is a FDA 510(k) cleared radiology medical device. Manufacturer: Cook, Inc.. Cleared Sep 1992. https://www.510kdatabase.net/k923236/ 1992-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k923236-triad-inlay-composite-fda-510k.jpg K923236 - TRIAD INLAY COMPOSITE K923236 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Sep 1992. https://www.510kdatabase.net/k923237/ 1992-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k923237-technicon-h2-fda-510k.jpg K923237 - TECHNICON H*2 K923237 is a FDA 510(k) cleared hematology medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Sep 1992. https://www.510kdatabase.net/k923270/ 1992-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k923270-kodak-ektascan-imagelink-quality-fda-510k.jpg K923270 - KODAK EKTASCAN IMAGELINK QUALITY CONTROL WORKSTATI K923270 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Sep 1992. https://www.510kdatabase.net/k921311/ 1992-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k921311-cordis-shuttle-catheter-w-sideholes-fda-510k.jpg K921311 - CORDIS SHUTTLE CATHETER W/ SIDEHOLES K921311 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Sep 1992. https://www.510kdatabase.net/k922698/ 1992-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k922698-du-pont-aca-plus-immunoassay-system-fda-510k.jpg K922698 - DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH CALIBRATOR K922698 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Sep 1992. https://www.510kdatabase.net/k922701/ 1992-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k922701-du-pont-aca-plus-immunoassay-system-fda-510k.jpg K922701 - DU PONT ACA PLUS IMMUNOASSAY SYSTEM TSH METHOD K922701 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Sep 1992. https://www.510kdatabase.net/k922856/ 1992-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k922856-systemate-direct-bilirubin-test-fda-510k.jpg K922856 - SYSTEMATE DIRECT BILIRUBIN TEST TECHNICON RA 1000 K922856 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Sep 1992. https://www.510kdatabase.net/k922857/ 1992-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k922857-systamate-aspartate-aminotransferase-fda-510k.jpg K922857 - SYSTAMATE ASPARTATE AMINOTRANSFERASE TEST TECHNICO K922857 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Sep 1992. https://www.510kdatabase.net/k922953/ 1992-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k922953-systemate-calcium-test-technicon-ra-1000-fda-510k.jpg K922953 - SYSTEMATE CALCIUM TEST TECHNICON RA 1000 K922953 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Sep 1992. https://www.510kdatabase.net/k923035/ 1992-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k923035-miles-urine-urea-nitrogen-method-fda-510k.jpg K923035 - MILES URINE UREA NITROGEN METHOD K923035 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Sep 1992. https://www.510kdatabase.net/k923036/ 1992-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k923036-urine-chloride-fda-510k.jpg K923036 - URINE CHLORIDE K923036 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Sep 1992. https://www.510kdatabase.net/k923083/ 1992-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k923083-total-bilirubin-catalog-no-65407-fda-510k.jpg K923083 - TOTAL BILIRUBIN CATALOG NO. 65407 K923083 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Sep 1992. https://www.510kdatabase.net/k923203/ 1992-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k923203-systemate-creatinine-test-fda-510k.jpg K923203 - SYSTEMATE CREATININE TEST K923203 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Sep 1992. https://www.510kdatabase.net/k923267/ 1992-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k923267-systemate-total-protein-test-technicon-fda-510k.jpg K923267 - SYSTEMATE TOTAL PROTEIN TEST, TECHNICON RA 1000 K923267 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Sep 1992. https://www.510kdatabase.net/k923328/ 1992-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k923328-veneer-cement-fda-510k.jpg K923328 - VENEER CEMENT K923328 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Sep 1992. https://www.510kdatabase.net/k923677/ 1992-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k923677-amylase-test-fda-510k.jpg K923677 - AMYLASE TEST K923677 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Sep 1992. https://www.510kdatabase.net/k921640/ 1992-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k921640-kinemax-plus-all-plastic-tibial-fda-510k.jpg K921640 - KINEMAX PLUS ALL PLASTIC TIBIAL COMPONENT K921640 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Sep 1992. https://www.510kdatabase.net/k922048/ 1992-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k922048-duracon-all-plastic-tibial-component-fda-510k.jpg K922048 - DURACON ALL PLASTIC TIBIAL COMPONENT K922048 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Sep 1992. https://www.510kdatabase.net/k922295/ 1992-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k922295-omega-plus-compress-hip-screw-system-fda-510k.jpg K922295 - OMEGA PLUS COMPRESS HIP SCREW SYSTEM, MODIFICATION K922295 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Sep 1992. https://www.510kdatabase.net/k922364/ 1992-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k922364-dua-900a-image-intensified-fda-510k.jpg K922364 - DUA-900A IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYST K922364 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Sep 1992. https://www.510kdatabase.net/k920743/ 1992-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k920743-dual-lead-ecg1-ecg2-arrhythmia-analysis-fda-510k.jpg K920743 - DUAL LEAD (ECG1 & ECG2) ARRHYTHMIA ANALYSIS K920743 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Sep 1992. https://www.510kdatabase.net/k922620/ 1992-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k922620-amk-fixed-stem-cemented-tibial-tray-fda-510k.jpg K922620 - AMK FIXED STEM CEMENTED TIBIAL TRAY K922620 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Sep 1992. https://www.510kdatabase.net/k921949/ 1992-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k921949-cotube-pth-irma-fda-510k.jpg K921949 - COTUBE PTH IRMA K921949 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Sep 1992. https://www.510kdatabase.net/k922170/ 1992-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k922170-amerlite-prolactin-30-assay-fda-510k.jpg K922170 - AMERLITE PROLACTIN-30 ASSAY K922170 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Sep 1992. https://www.510kdatabase.net/k922254/ 1992-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k922254-lukens-2-0-braided-silk-sutures-fda-510k.jpg K922254 - LUKENS 2-0 BRAIDED SILK SUTURES K922254 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Sep 1992. https://www.510kdatabase.net/k922804/ 1992-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k922804-awos-angiographic-workstation-fda-510k.jpg K922804 - AWOS ANGIOGRAPHIC WORKSTATION K922804 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 1992. https://www.510kdatabase.net/k922991/ 1992-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k922991-abbott-tdxtdxflx-and-tdxflx-theophylline-fda-510k.jpg K922991 - ABBOTT TDX/TDXFLX AND TDXFLX THEOPHYLLINE K922991 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1992. https://www.510kdatabase.net/k920342/ 1992-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k920342-bard-stone-removal-balloon-catheter-fda-510k.jpg K920342 - BARD STONE REMOVAL BALLOON CATHETER K920342 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Aug 1992. https://www.510kdatabase.net/k921826/ 1992-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k921826-kodak-insight-portable-imaging-system-fda-510k.jpg K921826 - KODAK INSIGHT PORTABLE IMAGING SYSTEM K921826 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Aug 1992. https://www.510kdatabase.net/k921697/ 1992-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k921697-flexiflo-companion-enteral-pump-sets-fda-510k.jpg K921697 - FLEXIFLO COMPANION ENTERAL PUMP SETS AND CONTAINER K921697 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1992. https://www.510kdatabase.net/k923317/ 1992-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k923317-columnmate-beta-thal-hba2-control-fda-510k.jpg K923317 - COLUMNMATE BETA THAL HBA2 CONTROL-ABNORMAL K923317 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Aug 1992. https://www.510kdatabase.net/k923318/ 1992-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k923318-columnmate-beta-thal-hba2-control-normal-fda-510k.jpg K923318 - COLUMNMATE BETA-THAL HBA2 CONTROL - NORMAL K923318 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Aug 1992. https://www.510kdatabase.net/k920980/ 1992-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k920980-usci-linx-ez-guide-wire-extension-fda-510k.jpg K920980 - USCI LINX EZ GUIDE WIRE EXTENSION W/PRO/PEL COAT K920980 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Aug 1992. https://www.510kdatabase.net/k922411/ 1992-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k922411-kodak-ektascan-xlt7720-xlt7700-pcd-2000-fda-510k.jpg K922411 - KODAK EKTASCAN, XLT7720, XLT7700, PCD 2000 K922411 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Aug 1992. https://www.510kdatabase.net/k922913/ 1992-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k922913-emit-2000-quindine-assay-quididine-fda-510k.jpg K922913 - EMIT 2000 QUINDINE ASSAY QUIDIDINE CALIBRATORS K922913 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Aug 1992. https://www.510kdatabase.net/k922914/ 1992-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k922914-emit-2000-procainamide-calibrators-fda-510k.jpg K922914 - EMIT 2000 PROCAINAMIDE CALIBRATORS K922914 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Aug 1992. https://www.510kdatabase.net/k922915/ 1992-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k922915-emit-2000-n-acetylprocainamide-assay-fda-510k.jpg K922915 - EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY AND CALIBRAT K922915 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Aug 1992. https://www.510kdatabase.net/k922916/ 1992-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k922916-bard-marlex-mesh-dart-fda-510k.jpg K922916 - BARD MARLEX MESH DART K922916 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Aug 1992. https://www.510kdatabase.net/k923038/ 1992-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k923038-miles-potassium-method-fda-510k.jpg K923038 - MILES POTASSIUM METHOD K923038 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Aug 1992. https://www.510kdatabase.net/k923039/ 1992-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k923039-miles-urine-creatinine-method-fda-510k.jpg K923039 - MILES URINE CREATININE METHOD K923039 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Aug 1992. https://www.510kdatabase.net/k920714/ 1992-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k920714-vista-hpq-system-fda-510k.jpg K920714 - VISTA HPQ SYSTEM K920714 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Aug 1992. https://www.510kdatabase.net/k922680/ 1992-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k922680-du-pont-aca-plus-immunoassay-system-fda-510k.jpg K922680 - DU PONT ACA PLUS IMMUNOASSAY SYSTEM INSTRUMENT K922680 is a FDA 510(k) cleared hematology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Aug 1992. https://www.510kdatabase.net/k922700/ 1992-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k922700-du-pont-aca-plus-immunoassay-system-mb-fda-510k.jpg K922700 - DU PONT ACA PLUS IMMUNOASSAY SYSTEM MB MCKMB METH. K922700 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Aug 1992. https://www.510kdatabase.net/k922273/ 1992-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k922273-arrayr-360-fda-510k.jpg K922273 - ARRAY(R) 360 K922273 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Aug 1992. https://www.510kdatabase.net/k922053/ 1992-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k922053-rep-spe-plus-ponceau-s-system-fda-510k.jpg K922053 - REP SPE PLUS (PONCEAU S) SYSTEM K922053 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Aug 1992. https://www.510kdatabase.net/k923411/ 1992-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k923411-olympus-magnesium-reagent-fda-510k.jpg K923411 - OLYMPUS MAGNESIUM REAGENT K923411 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Aug 1992. https://www.510kdatabase.net/k923564/ 1992-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k923564-olympus-inorganic-phosphorus-reagent-fda-510k.jpg K923564 - OLYMPUS INORGANIC PHOSPHORUS REAGENT K923564 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Aug 1992. https://www.510kdatabase.net/k923608/ 1992-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k923608-olympus-direct-bilirubin-reagent-fda-510k.jpg K923608 - OLYMPUS DIRECT BILIRUBIN REAGENT K923608 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Aug 1992. https://www.510kdatabase.net/k920820/ 1992-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k920820-modification-columnmate-fda-510k.jpg K920820 - MODIFICATION COLUMNMATE K920820 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Aug 1992. https://www.510kdatabase.net/k922349/ 1992-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k922349-dowdtm-ii-fda-510k.jpg K922349 - DOWD(TM) II K922349 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Aug 1992. https://www.510kdatabase.net/k922285/ 1992-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k922285-agc-and-maxim-knee-components-with-nts-fda-510k.jpg K922285 - AGC AND MAXIM KNEE COMPONENTS WITH NTS K922285 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Aug 1992. https://www.510kdatabase.net/k920012/ 1992-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k920012-il-testtm-alpha-2-antiplasmin-assay-fda-510k.jpg K920012 - IL TEST(TM) ALPHA-2-ANTIPLASMIN ASSAY SYSTEM K920012 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Aug 1992. https://www.510kdatabase.net/k920528/ 1992-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k920528-catheter-introducer-fda-510k.jpg K920528 - CATHETER INTRODUCER K920528 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Aug 1992. https://www.510kdatabase.net/k921777/ 1992-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k921777-cardiac-first-pass-analysis-fda-510k.jpg K921777 - CARDIAC FIRST PASS ANALYSIS K921777 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Aug 1992. https://www.510kdatabase.net/k922696/ 1992-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k922696-du-pont-aca-plus-immunoasssay-system-fda-510k.jpg K922696 - DU PONT ACA PLUS IMMUNOASSSAY SYSTEM HCG CALIBRATO K922696 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Aug 1992. https://www.510kdatabase.net/k922104/ 1992-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k922104-7000-series-total-knee-modular-fda-510k.jpg K922104 - 7000 SERIES TOTAL KNEE MODULAR COMPONENT CEMENT CA K922104 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Aug 1992. https://www.510kdatabase.net/k922146/ 1992-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k922146-ostroncs-hemi-hip-stem-series-fda-510k.jpg K922146 - OSTRONCS HEMI-HIP STEM SERIES K922146 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Aug 1992. https://www.510kdatabase.net/k910992/ 1992-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k910992-amk-total-knee-system-wdu-pont-fda-510k.jpg K910992 - AMK TOTAL KNEE SYSTEM W/DU PONT ENHANCED UHMWPE K910992 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Aug 1992. https://www.510kdatabase.net/k922697/ 1992-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k922697-du-pont-aca-plus-immunoassay-system-fda-510k.jpg K922697 - DU PONT ACA PLUS IMMUNOASSAY SYSTEM HCG METHOD K922697 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Aug 1992. https://www.510kdatabase.net/k923165/ 1992-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k923165-amerlite-free-thyroid-control-sera-fda-510k.jpg K923165 - AMERLITE FREE THYROID CONTROL SERA LAN.4002 K923165 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Aug 1992. https://www.510kdatabase.net/k922240/ 1992-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k922240-electronic-photospot-20-fda-510k.jpg K922240 - ELECTRONIC PHOTOSPOT 20 K922240 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Aug 1992. https://www.510kdatabase.net/k920752/ 1992-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k920752-endopath-ils-endoscopic-circular-stapler-fda-510k.jpg K920752 - ENDOPATH ILS ENDOSCOPIC CIRCULAR STAPLER K920752 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Aug 1992. https://www.510kdatabase.net/k921617/ 1992-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k921617-cylinder-of-gas-can-of-gas-cc12f2-fda-510k.jpg K921617 - CYLINDER OF GAS, CAN OF GAS (CC12F2) K921617 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Bio-Rad. Cleared Aug 1992. https://www.510kdatabase.net/k923340/ 1992-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k923340-roche-abuscreen-onlinne-calibrators-fda-510k.jpg K923340 - ROCHE ABUSCREEN ONLINNE CALIBRATORS K923340 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Aug 1992. https://www.510kdatabase.net/k921994/ 1992-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k921994-bard-pca-ii-pump-with-program-cartridges-fda-510k.jpg K921994 - BARD PCA II PUMP WITH PROGRAM CARTRIDGES K921994 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Aug 1992. https://www.510kdatabase.net/k915678/ 1992-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k915678-merit-administration-set-fda-510k.jpg K915678 - MERIT ADMINISTRATION SET K915678 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jul 1992. https://www.510kdatabase.net/k915757/ 1992-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k915757-models-m1722a-m1723a-m1724a-fda-510k.jpg K915757 - MODELS M1722A, M1723A, M1724A DEFIBRILLATORS K915757 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Jul 1992. https://www.510kdatabase.net/k920437/ 1992-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k920437-synthetic-absorbable-suture-undyed-fda-510k.jpg K920437 - SYNTHETIC ABSORBABLE SUTURE, UNDYED K920437 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Jul 1992. https://www.510kdatabase.net/k922184/ 1992-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k922184-hp-sonos-100-cf-ultrasound-imaging-fda-510k.jpg K922184 - HP SONOS 100 CF ULTRASOUND IMAGING SYSTEM K922184 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Jul 1992. https://www.510kdatabase.net/k915829/ 1992-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k915829-il-testtm-haptoglobin-hpt-fda-510k.jpg K915829 - IL TEST(TM) HAPTOGLOBIN (HPT) K915829 is a FDA 510(k) cleared immunology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jul 1992. https://www.510kdatabase.net/k920005/ 1992-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k920005-il-test-alpha-1-antitrypsin-aat-fda-510k.jpg K920005 - IL TEST ALPHA-1-ANTITRYPSIN (AAT) K920005 is a FDA 510(k) cleared immunology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jul 1992. https://www.510kdatabase.net/k921180/ 1992-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k921180-cobas-core-immunochemistry-system-fda-510k.jpg K921180 - COBAS CORE IMMUNOCHEMISTRY SYSTEM K921180 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jul 1992. https://www.510kdatabase.net/k922884/ 1992-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k922884-olympus-alanine-aminotransferase-reagent-fda-510k.jpg K922884 - OLYMPUS ALANINE AMINOTRANSFERASE REAGENT K922884 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Jul 1992. https://www.510kdatabase.net/k922885/ 1992-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k922885-olympus-aspartate-aminotransferase-fda-510k.jpg K922885 - OLYMPUS ASPARTATE AMINOTRANSFERASE REAGENT K922885 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Jul 1992. https://www.510kdatabase.net/k922098/ 1992-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k922098-cag-02a-fda-510k.jpg K922098 - CAG-02A K922098 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Jul 1992. https://www.510kdatabase.net/k922302/ 1992-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k922302-jagwiretm-recanalization-guidewire-fda-510k.jpg K922302 - JAGWIRE(TM) RECANALIZATION GUIDEWIRE K922302 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Jul 1992. https://www.510kdatabase.net/k920653/ 1992-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k920653-il-test-bilirubin-totaldirect-fda-510k.jpg K920653 - IL TEST BILIRUBIN TOTAL/DIRECT K920653 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jul 1992. https://www.510kdatabase.net/k922024/ 1992-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k922024-rep-spe-plus-acid-blue-system-fda-510k.jpg K922024 - REP SPE PLUS (ACID BLUE) SYSTEM,# 3173/3174/3175 K922024 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Jul 1992. https://www.510kdatabase.net/k922721/ 1992-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k922721-vlc-dycal-ii-fda-510k.jpg K922721 - VLC DYCAL II K922721 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jul 1992. https://www.510kdatabase.net/k922490/ 1992-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k922490-abbott-strep-a-controls-fda-510k.jpg K922490 - ABBOTT STREP A CONTROLS K922490 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Jul 1992. https://www.510kdatabase.net/k921718/ 1992-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k921718-olympus-ise-module-fda-510k.jpg K921718 - OLYMPUS ISE MODULE K921718 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Jul 1992. https://www.510kdatabase.net/k921844/ 1992-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k921844-kodak-ektachem-dt-slides-nbil-fda-510k.jpg K921844 - KODAK EKTACHEM DT SLIDES (NBIL) K921844 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Jul 1992. https://www.510kdatabase.net/k921951/ 1992-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k921951-mpg-65-80-100-x-ray-generator-and-fda-510k.jpg K921951 - MPG 65-80-100 X-RAY GENERATOR AND CONTROL K921951 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jul 1992. https://www.510kdatabase.net/k922138/ 1992-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k922138-vista-ultrasensitive-htsh-assay-fda-510k.jpg K922138 - VISTA ULTRASENSITIVE HTSH ASSAY K922138 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Jul 1992. https://www.510kdatabase.net/k922139/ 1992-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k922139-vista-immunoassay-system-modification-fda-510k.jpg K922139 - VISTA IMMUNOASSAY SYSTEM -- MODIFICATION K922139 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Jul 1992. https://www.510kdatabase.net/k921881/ 1992-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k921881-vista-hpq-system-fda-510k.jpg K921881 - VISTA HPQ SYSTEM K921881 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Jul 1992. https://www.510kdatabase.net/k922369/ 1992-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k922369-olympus-albumin-reagent-fda-510k.jpg K922369 - OLYMPUS ALBUMIN REAGENT K922369 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Jul 1992. https://www.510kdatabase.net/k922756/ 1992-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k922756-olympus-uric-acid-reagent-fda-510k.jpg K922756 - OLYMPUS URIC ACID REAGENT K922756 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Jul 1992. https://www.510kdatabase.net/k914267/ 1992-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k914267-ge-4096-plus-ge-2048-fda-510k.jpg K914267 - GE 4096 PLUS & GE 2048 K914267 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Jul 1992. https://www.510kdatabase.net/k921939/ 1992-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k921939-seralyzerr-therapeutic-drug-assay-fda-510k.jpg K921939 - SERALYZER(R) THERAPEUTIC DRUG ASSAY CONTROL(ABNOR) K921939 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Jul 1992. https://www.510kdatabase.net/k922232/ 1992-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k922232-olympus-glucose-reagent-fda-510k.jpg K922232 - OLYMPUS GLUCOSE REAGENT K922232 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Jul 1992. https://www.510kdatabase.net/k922345/ 1992-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k922345-testpack-plus-strep-a-fda-510k.jpg K922345 - TESTPACK PLUS STREP A K922345 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Jul 1992. https://www.510kdatabase.net/k922361/ 1992-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k922361-olympus-total-protein-reagent-fda-510k.jpg K922361 - OLYMPUS TOTAL PROTEIN REAGENT K922361 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Jul 1992. https://www.510kdatabase.net/k910483/ 1992-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k910483-monotube-external-fixation-system-fda-510k.jpg K910483 - MONOTUBE EXTERNAL FIXATION SYSTEM K910483 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jul 1992. https://www.510kdatabase.net/k912437/ 1992-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k912437-irrigating-syringe-fda-510k.jpg K912437 - IRRIGATING SYRINGE K912437 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jul 1992. https://www.510kdatabase.net/k922459/ 1992-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k922459-olympus-creatine-kinase-reagent-fda-510k.jpg K922459 - OLYMPUS CREATINE KINASE REAGENT K922459 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Jul 1992. https://www.510kdatabase.net/k921520/ 1992-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k921520-vacutainer-brand-luer-adapter-fda-510k.jpg K921520 - VACUTAINER BRAND LUER ADAPTER K921520 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jul 1992. https://www.510kdatabase.net/k921676/ 1992-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k921676-columnmate-ii-fda-510k.jpg K921676 - COLUMNMATE II K921676 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Jul 1992. https://www.510kdatabase.net/k922046/ 1992-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k922046-lyphochek-unassayed-chemistry-control-fda-510k.jpg K922046 - LYPHOCHEK UNASSAYED CHEMISTRY CONTROL LEVEL 3 K922046 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Jul 1992. https://www.510kdatabase.net/k922072/ 1992-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k922072-kodak-ektachem-250-analyer-fda-510k.jpg K922072 - KODAK EKTACHEM 250 ANALYER K922072 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Jul 1992. https://www.510kdatabase.net/k922233/ 1992-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k922233-olympus-calcium-reagent-fda-510k.jpg K922233 - OLYMPUS CALCIUM REAGENT K922233 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Jul 1992. https://www.510kdatabase.net/k922597/ 1992-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k922597-olympus-urea-nitrogen-bun-reagent-fda-510k.jpg K922597 - OLYMPUS UREA NITROGEN (BUN) REAGENT K922597 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Jul 1992. https://www.510kdatabase.net/k922736/ 1992-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k922736-kodak-amerlite-tsh-30-ultrasensitive-fda-510k.jpg K922736 - KODAK AMERLITE TSH-30 ULTRASENSITIVE STANDARD SERA K922736 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Jul 1992. https://www.510kdatabase.net/k922762/ 1992-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k922762-roche-reagent-for-uric-acid-modification-fda-510k.jpg K922762 - ROCHE REAGENT FOR URIC ACID--MODIFICATION K922762 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jul 1992. https://www.510kdatabase.net/k921558/ 1992-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k921558-medtronic-models-3983a-and-3983b-fda-510k.jpg K921558 - MEDTRONIC MODELS 3983A AND 3983B RESUME LEADS K921558 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Jul 1992. https://www.510kdatabase.net/k921619/ 1992-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k921619-dental-porcelain-fda-510k.jpg K921619 - DENTAL PORCELAIN K921619 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jul 1992. https://www.510kdatabase.net/k921639/ 1992-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k921639-bias-total-hip-system-300-mm-femoral-fda-510k.jpg K921639 - BIAS TOTAL HIP SYSTEM 300-MM FEMORAL STEM K921639 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jul 1992. https://www.510kdatabase.net/k921654/ 1992-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k921654-mclean-stock-percutaneous-t-tube-set-fda-510k.jpg K921654 - MCLEAN-STOCK PERCUTANEOUS T-TUBE SET K921654 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook, Inc.. Cleared Jul 1992. https://www.510kdatabase.net/k922229/ 1992-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k922229-olympus-triglyceride-reagent-fda-510k.jpg K922229 - OLYMPUS TRIGLYCERIDE REAGENT K922229 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Jul 1992. https://www.510kdatabase.net/k920946/ 1992-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k920946-urological-balloon-dilatation-catheter-fda-510k.jpg K920946 - UROLOGICAL BALLOON DILATATION CATHETER K920946 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Jul 1992. https://www.510kdatabase.net/k921139/ 1992-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k921139-healey-revision-component-system-fda-510k.jpg K921139 - HEALEY REVISION COMPONENT SYSTEM K921139 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jul 1992. https://www.510kdatabase.net/k921743/ 1992-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k921743-kodak-ektascan-2180-laser-printer-fda-510k.jpg K921743 - KODAK EKTASCAN 2180 LASER PRINTER K921743 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Jul 1992. https://www.510kdatabase.net/k922475/ 1992-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k922475-bactec-9120-system-fda-510k.jpg K922475 - BACTEC 9120 SYSTEM K922475 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jul 1992. https://www.510kdatabase.net/k920639/ 1992-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k920639-rx-90-acetabular-component-system-fda-510k.jpg K920639 - RX 90 ACETABULAR COMPONENT SYSTEM K920639 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jun 1992. https://www.510kdatabase.net/k920640/ 1992-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k920640-full-hemisphere-ring-loc-liner-fda-510k.jpg K920640 - FULL HEMISPHERE RING-LOC LINER K920640 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jun 1992. https://www.510kdatabase.net/k920800/ 1992-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k920800-integrated-endoscopy-system-1000-fda-510k.jpg K920800 - INTEGRATED ENDOSCOPY SYSTEM 1000 K920800 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jun 1992. https://www.510kdatabase.net/k921365/ 1992-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k921365-nutrimix-microcompounder-fda-510k.jpg K921365 - NUTRIMIX MICROCOMPOUNDER K921365 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1992. https://www.510kdatabase.net/k921661/ 1992-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k921661-boehringer-mannheim-hitachi-911-analyzer-fda-510k.jpg K921661 - BOEHRINGER MANNHEIM/ HITACHI 911 ANALYZER K921661 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jun 1992. https://www.510kdatabase.net/k915378/ 1992-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k915378-weck-trocar-fda-510k.jpg K915378 - WECK TROCAR K915378 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Edward Weck, Inc.. Cleared Jun 1992. https://www.510kdatabase.net/k921465/ 1992-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k921465-cat-no-1471-110v-cat-no-1472-220v-fda-510k.jpg K921465 - CAT. NO. 1471 (110V) & CAT. NO. 1472 (220V) K921465 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Jun 1992. https://www.510kdatabase.net/k920258/ 1992-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k920258-qbc-fibrinogen-fda-510k.jpg K920258 - QBC FIBRINOGEN K920258 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jun 1992. https://www.510kdatabase.net/k921383/ 1992-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k921383-precision-strata-total-hip-stem-fda-510k.jpg K921383 - PRECISION STRATA TOTAL HIP STEM K921383 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jun 1992. https://www.510kdatabase.net/k921384/ 1992-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k921384-pca-acetabular-insert-ii-fda-510k.jpg K921384 - PCA ACETABULAR INSERT II K921384 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jun 1992. https://www.510kdatabase.net/k921614/ 1992-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k921614-milenia-folic-acid-fda-510k.jpg K921614 - MILENIA FOLIC ACID K921614 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jun 1992. https://www.510kdatabase.net/k922220/ 1992-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k922220-olympus-au5200-clinical-chemistry-fda-510k.jpg K922220 - OLYMPUS AU5200 CLINICAL CHEMISTRY ANALYZER K922220 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Jun 1992. https://www.510kdatabase.net/k922230/ 1992-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k922230-olympus-ggt-reagent-fda-510k.jpg K922230 - OLYMPUS GGT REAGENT K922230 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Jun 1992. https://www.510kdatabase.net/k915735/ 1992-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k915735-flexiflo-quantum-ent-pump-sets-and-ent-fda-510k.jpg K915735 - FLEXIFLO QUANTUM ENT. PUMP SETS AND ENT. NUT. CONT K915735 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1992. https://www.510kdatabase.net/k920829/ 1992-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k920829-cobas-core-ferritin-eia-fda-510k.jpg K920829 - COBAS CORE FERRITIN EIA K920829 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jun 1992. https://www.510kdatabase.net/k920927/ 1992-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k920927-kemtrol-serum-control-normal-cat-no-7024-fda-510k.jpg K920927 - KEMTROL SERUM CONTROL-NORMAL CAT NO. 7024 K920927 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Jun 1992. https://www.510kdatabase.net/k920973/ 1992-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k920973-bactidrop-indole-erlichs-fda-510k.jpg K920973 - BACTIDROP INDOLE (ERLICH'S) K920973 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Jun 1992. https://www.510kdatabase.net/k920974/ 1992-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k920974-bactidrop-acridine-orange-fda-510k.jpg K920974 - BACTIDROP ACRIDINE ORANGE K920974 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Jun 1992. https://www.510kdatabase.net/k920007/ 1992-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k920007-il-test-complement-3-fda-510k.jpg K920007 - IL TEST COMPLEMENT 3 K920007 is a FDA 510(k) cleared immunology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jun 1992. https://www.510kdatabase.net/k920014/ 1992-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k920014-il-test-immunoglobulin-a-fda-510k.jpg K920014 - IL TEST IMMUNOGLOBULIN A K920014 is a FDA 510(k) cleared immunology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jun 1992. https://www.510kdatabase.net/k922043/ 1992-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k922043-roche-calibrator-serum-fda-510k.jpg K922043 - ROCHE CALIBRATOR SERUM K922043 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jun 1992. https://www.510kdatabase.net/k922380/ 1992-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k922380-bite-rim-wax-fda-510k.jpg K922380 - BITE RIM WAX K922380 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jun 1992. https://www.510kdatabase.net/k921609/ 1992-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k921609-vista-hphpq-system-fda-510k.jpg K921609 - VISTA HP/HPQ SYSTEM K921609 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Jun 1992. https://www.510kdatabase.net/k914752/ 1992-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k914752-auto-suturer-articulating-endoscopic-fda-510k.jpg K914752 - AUTO SUTURE(R) ARTICULATING ENDOSCOPIC SCISSORS K914752 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Jun 1992. https://www.510kdatabase.net/k914753/ 1992-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k914753-auto-suturer-articulating-endoscopic-fda-510k.jpg K914753 - AUTO SUTURE(R) ARTICULATING ENDOSCOPIC CLAMP K914753 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Jun 1992. https://www.510kdatabase.net/k920942/ 1992-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k920942-olympus-au800-clinical-chemistry-fda-510k.jpg K920942 - OLYMPUS AU800 CLINICAL CHEMISTRY ANALYZER K920942 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Jun 1992. https://www.510kdatabase.net/k920143/ 1992-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k920143-tb-susceptibility-quads-i-and-ii-fda-510k.jpg K920143 - TB SUSCEPTIBILITY QUADS I AND II K920143 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Jun 1992. https://www.510kdatabase.net/k920970/ 1992-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k920970-bactidrop-koh-10-fda-510k.jpg K920970 - BACTIDROP KOH (10%) K920970 is a FDA 510(k) cleared pathology medical device. Manufacturer: Remel Co.. Cleared Jun 1992. https://www.510kdatabase.net/k920975/ 1992-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k920975-bactidrop-calcofluor-white-fda-510k.jpg K920975 - BACTIDROP CALCOFLUOR WHITE K920975 is a FDA 510(k) cleared pathology medical device. Manufacturer: Remel Co.. Cleared Jun 1992. https://www.510kdatabase.net/k920976/ 1992-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k920976-bactidrop-india-ink-fda-510k.jpg K920976 - BACTIDROP INDIA INK K920976 is a FDA 510(k) cleared pathology medical device. Manufacturer: Remel Co.. Cleared Jun 1992. https://www.510kdatabase.net/k921232/ 1992-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k921232-keane-uni-knee-system-with-porocoat-fda-510k.jpg K921232 - KEANE UNI KNEE SYSTEM WITH POROCOAT K921232 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jun 1992. https://www.510kdatabase.net/k921286/ 1992-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k921286-liquichek-lipids-control-levels-1-and-2-fda-510k.jpg K921286 - LIQUICHEK LIPIDS CONTROL LEVELS 1 AND 2 K921286 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Jun 1992. https://www.510kdatabase.net/k921305/ 1992-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k921305-glyco-tek-affinity-column-kit-fda-510k.jpg K921305 - GLYCO-TEK AFFINITY COLUMN KIT K921305 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Jun 1992. https://www.510kdatabase.net/k921363/ 1992-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k921363-cascade-480-fda-510k.jpg K921363 - CASCADE 480 K921363 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Jun 1992. https://www.510kdatabase.net/k921701/ 1992-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k921701-durafill-bond-fda-510k.jpg K921701 - DURAFILL BOND K921701 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Jun 1992. https://www.510kdatabase.net/k921703/ 1992-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k921703-continu-flor-solution-set-fda-510k.jpg K921703 - CONTINU-FLO(R) SOLUTION SET K921703 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jun 1992. https://www.510kdatabase.net/k914299/ 1992-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k914299-cardiac-catherization-kit-fda-510k.jpg K914299 - CARDIAC CATHERIZATION KIT K914299 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1992. https://www.510kdatabase.net/k920998/ 1992-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k920998-gore-tunneler-modification-fda-510k.jpg K920998 - GORE TUNNELER, MODIFICATION K920998 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Jun 1992. https://www.510kdatabase.net/k915526/ 1992-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k915526-coated-surgiprotm-polypropylene-fda-510k.jpg K915526 - COATED SURGIPRO(TM) POLYPROPYLENE SURGICAL MESH K915526 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared May 1992. https://www.510kdatabase.net/k915695/ 1992-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k915695-procel-burn-cover-fda-510k.jpg K915695 - PROCEL BURN COVER K915695 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared May 1992. https://www.510kdatabase.net/k920847/ 1992-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k920847-ethicon-ligaclip-endo-ld-applierdivider-fda-510k.jpg K920847 - ETHICON LIGACLIP ENDO LD APPLIER/DIVIDER K920847 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared May 1992. https://www.510kdatabase.net/k921036/ 1992-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k921036-sonos-100-ultrasound-imaging-system-fda-510k.jpg K921036 - SONOS 100 ULTRASOUND IMAGING SYSTEM K921036 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared May 1992. https://www.510kdatabase.net/k914092/ 1992-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k914092-bsm-2100a-configured-patient-monitor-fda-510k.jpg K914092 - BSM-2100A CONFIGURED PATIENT MONITOR K914092 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared May 1992. https://www.510kdatabase.net/k915357/ 1992-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k915357-promeon-hydrogel-dressing-45-sterile-fda-510k.jpg K915357 - PROMEON HYDROGEL DRESSING #45 STERILE W/O MESH K915357 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medtronic Vascular. Cleared May 1992. https://www.510kdatabase.net/k915359/ 1992-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k915359-promeon-hydrogel-dressing-45-sterile-w-fda-510k.jpg K915359 - PROMEON HYDROGEL DRESSING #45 STERILE W/ MESH K915359 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medtronic Vascular. Cleared May 1992. https://www.510kdatabase.net/k920190/ 1992-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k920190-ultra-vision-rapid-intensifying-screen-fda-510k.jpg K920190 - ULTRA-VISION RAPID INTENSIFYING SCREEN K920190 is a FDA 510(k) cleared radiology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared May 1992. https://www.510kdatabase.net/k920200/ 1992-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k920200-ultra-vision-detail-intensifying-screen-fda-510k.jpg K920200 - ULTRA-VISION DETAIL INTENSIFYING SCREEN K920200 is a FDA 510(k) cleared radiology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared May 1992. https://www.510kdatabase.net/k920194/ 1992-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k920194-ultra-vision-fast-detail-intensifying-fda-510k.jpg K920194 - ULTRA-VISION FAST DETAIL INTENSIFYING SCREEN K920194 is a FDA 510(k) cleared radiology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared May 1992. https://www.510kdatabase.net/k920268/ 1992-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k920268-3m-digital-disk-interface-unit-fda-510k.jpg K920268 - 3M DIGITAL DISK INTERFACE UNIT K920268 is a FDA 510(k) cleared radiology medical device. Manufacturer: 3M Company. Cleared May 1992. https://www.510kdatabase.net/k920868/ 1992-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k920868-acetabular-dome-and-screw-hole-plugs-fda-510k.jpg K920868 - ACETABULAR DOME AND SCREW HOLE PLUGS K920868 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared May 1992. https://www.510kdatabase.net/k921998/ 1992-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k921998-abuscreenr-onlinetm-for-amphetamines-fda-510k.jpg K921998 - ABUSCREEN(R) ONLINE(TM) FOR AMPHETAMINES, MODIFIED K921998 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared May 1992. https://www.510kdatabase.net/k920119/ 1992-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k920119-3m-dental-electronic-anesthesia-system-fda-510k.jpg K920119 - 3M DENTAL ELECTRONIC ANESTHESIA SYSTEM K920119 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared May 1992. https://www.510kdatabase.net/k920225/ 1992-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k920225-autosceptor-identification-system-fda-510k.jpg K920225 - AUTOSCEPTOR IDENTIFICATION SYSTEM K920225 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared May 1992. https://www.510kdatabase.net/k920837/ 1992-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k920837-sterile-convertor-safecare-gown-and-fda-510k.jpg K920837 - STERILE CONVERTOR SAFECARE GOWN AND DRAPE K920837 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared May 1992. https://www.510kdatabase.net/k920971/ 1992-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k920971-bactidrop-ninhydrin-fda-510k.jpg K920971 - BACTIDROP NINHYDRIN K920971 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared May 1992. https://www.510kdatabase.net/k920972/ 1992-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k920972-bactidrop-pyr-fda-510k.jpg K920972 - BACTIDROP PYR K920972 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared May 1992. https://www.510kdatabase.net/k921124/ 1992-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k921124-models-6917t-6917at-4951m-epicardial-fda-510k.jpg K921124 - MODELS 6917T, 6917AT & 4951M EPICARDIAL PACE LEADS K921124 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared May 1992. https://www.510kdatabase.net/k920436/ 1992-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k920436-medtronic-respond-iii-neuromuscular-fda-510k.jpg K920436 - MEDTRONIC RESPOND III NEUROMUSCULAR STIMULATOR K920436 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Medtronic Vascular. Cleared May 1992. https://www.510kdatabase.net/k920567/ 1992-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k920567-models-3987-and-3988-resume-lead-for-pns-fda-510k.jpg K920567 - MODELS 3987 AND 3988 RESUME LEAD FOR PNS K920567 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared May 1992. https://www.510kdatabase.net/k914565/ 1992-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k914565-osteonics-7000-posterior-stab-total-fda-510k.jpg K914565 - OSTEONICS 7000 POSTERIOR STAB. TOTAL KNEE FEM. COM K914565 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared May 1992. https://www.510kdatabase.net/k915828/ 1992-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k915828-injection-site-with-luer-lock-fda-510k.jpg K915828 - INJECTION SITE WITH LUER LOCK K915828 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared May 1992. https://www.510kdatabase.net/k920094/ 1992-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k920094-magnetic-resonance-diagnostic-device-fda-510k.jpg K920094 - MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES K920094 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 1992. https://www.510kdatabase.net/k920524/ 1992-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k920524-osteonics-7000-series-total-knee-bone-fda-510k.jpg K920524 - OSTEONICS 7000 SERIES TOTAL KNEE BONE AUGMENTATION K920524 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared May 1992. https://www.510kdatabase.net/k920577/ 1992-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k920577-howedica-zirconia-femoral-head-fda-510k.jpg K920577 - HOWEDICA ZIRCONIA FEMORAL HEAD K920577 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared May 1992. https://www.510kdatabase.net/k920949/ 1992-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k920949-software-modification-for-miles-h1-sw-fda-510k.jpg K920949 - SOFTWARE MODIFICATION FOR MILES H*1 S/W VER. 1.5 K920949 is a FDA 510(k) cleared hematology medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared May 1992. https://www.510kdatabase.net/k921098/ 1992-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k921098-magnetom-63sp-fda-510k.jpg K921098 - MAGNETOM 63SP K921098 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 1992. https://www.510kdatabase.net/k921191/ 1992-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k921191-gianturco-rosch-biliary-z-stent-fda-510k.jpg K921191 - GIANTURCO-ROSCH BILIARY Z STENT K921191 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook, Inc.. Cleared May 1992. https://www.510kdatabase.net/k921013/ 1992-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k921013-syva-emit-ii-methaqualone-assay-fda-510k.jpg K921013 - SYVA EMIT II METHAQUALONE ASSAY K921013 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared May 1992. https://www.510kdatabase.net/k920773/ 1992-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k920773-durafuse-infusion-pump-fda-510k.jpg K920773 - DURAFUSE INFUSION PUMP K920773 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared May 1992. https://www.510kdatabase.net/k921420/ 1992-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k921420-azithromycin-15-mcg-sensi-disc-fda-510k.jpg K921420 - AZITHROMYCIN, 15 MCG, SENSI DISC K921420 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared May 1992. https://www.510kdatabase.net/k920109/ 1992-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k920109-imx-insulin-fda-510k.jpg K920109 - IMX INSULIN K920109 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared May 1992. https://www.510kdatabase.net/k920926/ 1992-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k920926-kemtrol-serum-control-abnormal-fda-510k.jpg K920926 - KEMTROL SERUM CONTROL-ABNORMAL K920926 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared May 1992. https://www.510kdatabase.net/k914190/ 1992-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k914190-auto-suturer-endoscopic-fan-retractor-fda-510k.jpg K914190 - AUTO SUTURE(R) ENDOSCOPIC FAN RETRACTOR K914190 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared May 1992. https://www.510kdatabase.net/k920547/ 1992-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k920547-ultra-thin-fda-510k.jpg K920547 - ULTRA-THIN K920547 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared May 1992. https://www.510kdatabase.net/k921091/ 1992-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k921091-cholangiolapcathtm-fda-510k.jpg K921091 - CHOLANGIOLAPCATH(TM) K921091 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared May 1992. https://www.510kdatabase.net/k914856/ 1992-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k914856-vascular-catheter-wire-guides-wmedi-fda-510k.jpg K914856 - VASCULAR CATHETER & WIRE GUIDES W/MEDI-COAT(TM) K914856 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared May 1992. https://www.510kdatabase.net/k920147/ 1992-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k920147-thrombin-clotting-time-reagent-fda-510k.jpg K920147 - THROMBIN CLOTTING TIME REAGENT K920147 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared May 1992. https://www.510kdatabase.net/k921269/ 1992-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k921269-kodak-x-omat-model-180-lp-processor-fda-510k.jpg K921269 - KODAK X-OMAT MODEL 180 LP PROCESSOR K921269 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared May 1992. https://www.510kdatabase.net/k913117/ 1992-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k913117-zb-860pa-multiparameter-transmitter-fda-510k.jpg K913117 - ZB-860PA MULTIPARAMETER TRANSMITTER K913117 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Apr 1992. https://www.510kdatabase.net/k913731/ 1992-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k913731-enzygnostr-toxoplasmosisigg-fda-510k.jpg K913731 - ENZYGNOST(R) TOXOPLASMOSIS/IGG K913731 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Apr 1992. https://www.510kdatabase.net/k920402/ 1992-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k920402-roche-cobas-mira-plus-fda-510k.jpg K920402 - ROCHE COBAS MIRA PLUS K920402 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Apr 1992. https://www.510kdatabase.net/k920422/ 1992-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k920422-b-d-interlink-syringe-cannula-fda-510k.jpg K920422 - B-D INTERLINK SYRINGE CANNULA K920422 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1992. https://www.510kdatabase.net/k921089/ 1992-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k921089-lyphochekr-fructosamine-control-fda-510k.jpg K921089 - LYPHOCHEK(R) FRUCTOSAMINE CONTROL K921089 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Apr 1992. https://www.510kdatabase.net/k921455/ 1992-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k921455-aca-lactate-dehydrogenase-isoenzyme-1-fda-510k.jpg K921455 - ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHOD K921455 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Apr 1992. https://www.510kdatabase.net/k921636/ 1992-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k921636-vacutainerr-brand-safety-lok-blood-fda-510k.jpg K921636 - VACUTAINER(R) BRAND SAFETY-LOK BLOOD COLLECT SET K921636 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1992. https://www.510kdatabase.net/k921806/ 1992-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k921806-vacutainerr-brand-sstr-and-cat-tubes-fda-510k.jpg K921806 - VACUTAINER(R) BRAND SST(R) AND CAT TUBES K921806 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1992. https://www.510kdatabase.net/k913910/ 1992-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k913910-enzygnostr-anti-cmv-igg-fda-510k.jpg K913910 - ENZYGNOST(R) ANTI-CMV IGG K913910 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Apr 1992. https://www.510kdatabase.net/k915358/ 1992-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k915358-promeon-hydrogel-dressing-45-fda-510k.jpg K915358 - PROMEON HYDROGEL DRESSING #45 NONSTERILE W/ MESH K915358 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medtronic Vascular. Cleared Apr 1992. https://www.510kdatabase.net/k920758/ 1992-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k920758-jenker-needle-stick-protector-fda-510k.jpg K920758 - JENKER NEEDLE STICK PROTECTOR K920758 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Apr 1992. https://www.510kdatabase.net/k920376/ 1992-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k920376-corometrics-model-150-fetal-monitor-fda-510k.jpg K920376 - COROMETRICS MODEL 150 FETAL MONITOR K920376 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Apr 1992. https://www.510kdatabase.net/k920705/ 1992-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k920705-polytron-digital-imaging-system-fda-510k.jpg K920705 - POLYTRON DIGITAL IMAGING SYSTEM K920705 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 1992. https://www.510kdatabase.net/k920715/ 1992-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k920715-kodak-x-omat-fixer-manager-fda-510k.jpg K920715 - KODAK X-OMAT FIXER MANAGER K920715 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Apr 1992. https://www.510kdatabase.net/k921193/ 1992-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k921193-lomefloxacin-10-mcg-sensi-disc-fda-510k.jpg K921193 - LOMEFLOXACIN, 10 MCG, SENSI DISC K921193 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1992. https://www.510kdatabase.net/k921233/ 1992-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k921233-bard-4-wire-ureteroscopic-stone-fda-510k.jpg K921233 - BARD 4-WIRE URETEROSCOPIC STONE K921233 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 1992. https://www.510kdatabase.net/k920417/ 1992-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k920417-il-test-barbiturate-35289-fda-510k.jpg K920417 - IL TEST BARBITURATE, 35289 K920417 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Apr 1992. https://www.510kdatabase.net/k920858/ 1992-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k920858-il-test-methadone-fda-510k.jpg K920858 - IL TEST METHADONE K920858 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Apr 1992. https://www.510kdatabase.net/k921726/ 1992-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k921726-hayek-oscillator-modification-fda-510k.jpg K921726 - HAYEK OSCILLATOR, MODIFICATION K921726 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Apr 1992. https://www.510kdatabase.net/k915796/ 1992-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k915796-bactec-9240-system-fda-510k.jpg K915796 - BACTEC 9240 SYSTEM K915796 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1992. https://www.510kdatabase.net/k920257/ 1992-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k920257-niacin-control-disks-fda-510k.jpg K920257 - NIACIN CONTROL DISKS K920257 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Apr 1992. https://www.510kdatabase.net/k921133/ 1992-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k921133-bactec-plus-aerobicf-and-anaerobicf-fda-510k.jpg K921133 - BACTEC PLUS AEROBIC/F AND ANAEROBIC/F MEDIA K921133 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1992. https://www.510kdatabase.net/k905536/ 1992-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k905536-fetal-doppler-fda-510k.jpg K905536 - FETAL DOPPLER K905536 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Apr 1992. https://www.510kdatabase.net/k915165/ 1992-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k915165-argebond-77-fda-510k.jpg K915165 - ARGEBOND 77+ K915165 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Apr 1992. https://www.510kdatabase.net/k920286/ 1992-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k920286-depuy-total-hip-balls-ion-implantation-fda-510k.jpg K920286 - DEPUY TOTAL HIP BALLS - ION IMPLANTATION K920286 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Apr 1992. https://www.510kdatabase.net/k920321/ 1992-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k920321-becton-dickinson-safety-lok-syringe-fda-510k.jpg K920321 - BECTON DICKINSON SAFETY-LOK SYRINGE K920321 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1992. https://www.510kdatabase.net/k915498/ 1992-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k915498-cordis-angiographic-doppler-cather-fda-510k.jpg K915498 - CORDIS ANGIOGRAPHIC DOPPLER CATHER K915498 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Apr 1992. https://www.510kdatabase.net/k920933/ 1992-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k920933-bactec-fos-culture-supplement-fda-510k.jpg K920933 - BACTEC FOS CULTURE SUPPLEMENT K920933 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1992. https://www.510kdatabase.net/k920940/ 1992-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k920940-amerlite-free-thyroid-control-sera-fda-510k.jpg K920940 - AMERLITE FREE THYROID CONTROL SERA LAN.4002 K920940 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Apr 1992. https://www.510kdatabase.net/k915470/ 1992-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k915470-optima-nuclear-tomography-stystem-fda-510k.jpg K915470 - OPTIMA NUCLEAR TOMOGRAPHY STYSTEM K915470 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Apr 1992. https://www.510kdatabase.net/k920750/ 1992-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k920750-bard-ureteroscope-deflection-module-fda-510k.jpg K920750 - BARD URETEROSCOPE DEFLECTION MODULE K920750 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 1992. https://www.510kdatabase.net/k915110/ 1992-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k915110-flexiflo-over-the-guidewire-fda-510k.jpg K915110 - FLEXIFLO OVER-THE-GUIDEWIRE GASTROSTOMY KIT K915110 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1992. https://www.510kdatabase.net/k913987/ 1992-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k913987-or340-intraoperative-ultrasound-biopsy-fda-510k.jpg K913987 - OR340 INTRAOPERATIVE ULTRASOUND BIOPSY NEEDLE GUID K913987 is a FDA 510(k) cleared radiology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Apr 1992. https://www.510kdatabase.net/k920161/ 1992-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k920161-biomet-nts-femoral-components-fda-510k.jpg K920161 - BIOMET NTS FEMORAL COMPONENTS K920161 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Apr 1992. https://www.510kdatabase.net/k920416/ 1992-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k920416-supplementary-reagents-for-enzygnosttmb-fda-510k.jpg K920416 - SUPPLEMENTARY REAGENTS FOR ENZYGNOST/TMB K920416 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Apr 1992. https://www.510kdatabase.net/k920786/ 1992-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k920786-loracarbef-30mcg-sensi-disc-fda-510k.jpg K920786 - LORACARBEF 30MCG, SENSI DISC K920786 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1992. https://www.510kdatabase.net/k920787/ 1992-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k920787-temafloxcin-5mcg-sensi-disc-fda-510k.jpg K920787 - TEMAFLOXCIN, 5MCG, SENSI DISC K920787 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1992. https://www.510kdatabase.net/k921012/ 1992-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k921012-precise-chromatographic-immunoassay-fda-510k.jpg K921012 - PRECISE CHROMATOGRAPHIC IMMUNOASSAY FOR HCG K921012 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1992. https://www.510kdatabase.net/k920407/ 1992-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k920407-deseret-guidewire-introducer-ii-fda-510k.jpg K920407 - DESERET GUIDEWIRE INTRODUCER II K920407 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1992. https://www.510kdatabase.net/k920408/ 1992-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k920408-deseret-guidewire-introducer-iii-fda-510k.jpg K920408 - DESERET GUIDEWIRE INTRODUCER III K920408 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1992. https://www.510kdatabase.net/k920826/ 1992-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k920826-human-chorionic-gonadatrophin-and-fda-510k.jpg K920826 - HUMAN CHORIONIC GONADATROPHIN AND UNCON. ESTRIOL K920826 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Apr 1992. https://www.510kdatabase.net/k915286/ 1992-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k915286-lap-tissue-collection-bag-fda-510k.jpg K915286 - LAP TISSUE COLLECTION BAG K915286 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Baxter Healthcare Corp. Cleared Apr 1992. https://www.510kdatabase.net/k915495/ 1992-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k915495-deseret-positional-suture-wing-fda-510k.jpg K915495 - DESERET POSITIONAL SUTURE WING K915495 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1992. https://www.510kdatabase.net/k920635/ 1992-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k920635-e-z-setminicath-infusion-sets-fda-510k.jpg K920635 - E-Z SET/MINICATH INFUSION SETS K920635 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1992. https://www.510kdatabase.net/k920110/ 1992-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k920110-endopath-disposable-thoracic-trocar-fda-510k.jpg K920110 - ENDOPATH DISPOSABLE THORACIC TROCAR SLEEVE K920110 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Apr 1992. https://www.510kdatabase.net/k920374/ 1992-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k920374-aloka-650cl-diagnostic-ultrasound-system-fda-510k.jpg K920374 - ALOKA 650CL DIAGNOSTIC ULTRASOUND SYSTEM K920374 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Apr 1992. https://www.510kdatabase.net/k913798/ 1992-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k913798-sonolayer-alpha-model-ssh-140a-fda-510k.jpg K913798 - SONOLAYER ALPHA, MODEL SSH-140A K913798 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Apr 1992. https://www.510kdatabase.net/k912374/ 1992-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k912374-bardr-urotackr-210-monitoring-system-fda-510k.jpg K912374 - BARD(R) UROTACK(R) 210 MONITORING SYSTEM K912374 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 1992. https://www.510kdatabase.net/k920061/ 1992-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k920061-hemometrix-continuous-blood-gas-fda-510k.jpg K920061 - HEMOMETRIX CONTINUOUS BLOOD GAS MONITORING SYSTEM K920061 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1992. https://www.510kdatabase.net/k920289/ 1992-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k920289-cordis-bipal-7-biopsy-forceps-fda-510k.jpg K920289 - CORDIS BIPAL 7 BIOPSY FORCEPS K920289 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Mar 1992. https://www.510kdatabase.net/k920025/ 1992-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k920025-olympus-disposable-suction-valve-fda-510k.jpg K920025 - OLYMPUS DISPOSABLE SUCTION VALVE K920025 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Olympus Corp.. Cleared Mar 1992. https://www.510kdatabase.net/k920335/ 1992-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k920335-miles-alanine-aminotransferase-sera-fda-510k.jpg K920335 - MILES ALANINE AMINOTRANSFERASE SERA-PAK METHOD K920335 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Mar 1992. https://www.510kdatabase.net/k921087/ 1992-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k921087-chemstrip-urine-analyzer-fda-510k.jpg K921087 - CHEMSTRIP URINE ANALYZER K921087 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Mar 1992. https://www.510kdatabase.net/k911663/ 1992-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k911663-crosslink-system-fda-510k.jpg K911663 - CROSSLINK SYSTEM K911663 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Mar 1992. https://www.510kdatabase.net/k914690/ 1992-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k914690-lm15tm-catalog-number-523821-fda-510k.jpg K914690 - LM15(TM), CATALOG NUMBER - 523821 K914690 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Mar 1992. https://www.510kdatabase.net/k915330/ 1992-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k915330-directigen-meningitis-combo-test-kit-fda-510k.jpg K915330 - DIRECTIGEN MENINGITIS COMBO TEST KIT K915330 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1992. https://www.510kdatabase.net/k915835/ 1992-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k915835-coated-vicryl-ii-fda-510k.jpg K915835 - COATED VICRYL* II K915835 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Mar 1992. https://www.510kdatabase.net/k920473/ 1992-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k920473-cefprozil-30mcg-sensi-disc-fda-510k.jpg K920473 - CEFPROZIL 30MCG, SENSI DISC K920473 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1992. https://www.510kdatabase.net/k920505/ 1992-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k920505-amerlex-m-extended-range-human-fda-510k.jpg K920505 - AMERLEX-M EXTENDED RANGE HUMAN CHORIONIC GONADATR K920505 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Mar 1992. https://www.510kdatabase.net/k920565/ 1992-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k920565-bbl-strep-grouping-kit-fda-510k.jpg K920565 - BBL STREP GROUPING KIT K920565 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1992. https://www.510kdatabase.net/k920576/ 1992-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k920576-amerlex-m-high-sensitivity-fda-510k.jpg K920576 - AMERLEX-M HIGH SENSITIVITY UNCONJUGATED ESTRIOL K920576 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Mar 1992. https://www.510kdatabase.net/k920694/ 1992-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k920694-8000-series-volumetric-pump-non-fda-510k.jpg K920694 - 8000 SERIES VOLUMETRIC PUMP NON-GRAVITY FLOW SET K920694 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 1992. https://www.510kdatabase.net/k920424/ 1992-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k920424-scotchbond-brand-multi-purpose-fda-510k.jpg K920424 - SCOTCHBOND BRAND MULTI-PURPOSE ADHESIVE SYSTEM K920424 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Mar 1992. https://www.510kdatabase.net/k920425/ 1992-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k920425-3m-brand-restorative-z100-fda-510k.jpg K920425 - 3M BRAND RESTORATIVE Z100 K920425 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Mar 1992. https://www.510kdatabase.net/k914513/ 1992-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k914513-palavit-g-fda-510k.jpg K914513 - PALAVIT G K914513 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Mar 1992. https://www.510kdatabase.net/k915053/ 1992-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k915053-beckman-antistreptolysin-o-modification-fda-510k.jpg K915053 - BECKMAN ANTISTREPTOLYSIN O, MODIFICATION K915053 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Mar 1992. https://www.510kdatabase.net/k915099/ 1992-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k915099-endopath-endos-linear-cut-wsaf-lock-fda-510k.jpg K915099 - ENDOPATH ENDOS LINEAR CUT W/SAF LOCK-OUT/RELOAD UN K915099 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Mar 1992. https://www.510kdatabase.net/k915543/ 1992-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k915543-new-opaque-porcelain-fda-510k.jpg K915543 - NEW OPAQUE PORCELAIN K915543 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Mar 1992. https://www.510kdatabase.net/k915693/ 1992-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k915693-proximate-absorbable-staples-fda-510k.jpg K915693 - PROXIMATE ABSORBABLE STAPLES K915693 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Mar 1992. https://www.510kdatabase.net/k915721/ 1992-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k915721-model-ar-6300-infusion-pump-fda-510k.jpg K915721 - MODEL AR-6300 INFUSION PUMP K915721 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Arthrex, Inc.. Cleared Mar 1992. https://www.510kdatabase.net/k920559/ 1992-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k920559-abbott-vertex-analyzer-fda-510k.jpg K920559 - ABBOTT VERTEX ANALYZER K920559 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1992. https://www.510kdatabase.net/k915113/ 1992-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k915113-encore-fda-510k.jpg K915113 - ENCORE K915113 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Mar 1992. https://www.510kdatabase.net/k920251/ 1992-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k920251-usci-hemaquet-xt-introducer-fda-510k.jpg K920251 - USCI HEMAQUET XT INTRODUCER K920251 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 1992. https://www.510kdatabase.net/k920274/ 1992-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k920274-directigen-neisseria-meningitidis-test-fda-510k.jpg K920274 - DIRECTIGEN NEISSERIA MENINGITIDIS TEST K920274 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1992. https://www.510kdatabase.net/k920935/ 1992-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k920935-abuscreen-online-for-phencyclidine-fda-510k.jpg K920935 - ABUSCREEN ONLINE FOR PHENCYCLIDINE K920935 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Mar 1992. https://www.510kdatabase.net/k914167/ 1992-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k914167-clinical-chemanalacidprostatic-acid-fda-510k.jpg K914167 - CLINICAL CHEM.ANAL.ACID,PROSTATIC ACID PHOSPHATASE K914167 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Mar 1992. https://www.510kdatabase.net/k920530/ 1992-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k920530-intermedics-model-366-15-vs-1-header-fda-510k.jpg K920530 - INTERMEDICS MODEL 366-15 VS 1 HEADER PLUG K920530 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Mar 1992. https://www.510kdatabase.net/k913472/ 1992-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k913472-laparoscantm-intraoper-diag-ultrasound-fda-510k.jpg K913472 - LAPAROSCAN(TM) INTRAOPER DIAG ULTRASOUND SYSTEM K913472 is a FDA 510(k) cleared radiology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 1992. https://www.510kdatabase.net/k920006/ 1992-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k920006-il-test-immunoglobulin-g-igg-fda-510k.jpg K920006 - IL TEST IMMUNOGLOBULIN G (IGG) K920006 is a FDA 510(k) cleared immunology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Mar 1992. https://www.510kdatabase.net/k920010/ 1992-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k920010-il-test-complement-4-fda-510k.jpg K920010 - IL TEST COMPLEMENT 4 K920010 is a FDA 510(k) cleared immunology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Mar 1992. https://www.510kdatabase.net/k920751/ 1992-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k920751-syva-emit-ii-methadone-assay-fda-510k.jpg K920751 - SYVA EMIT II METHADONE ASSAY K920751 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Mar 1992. https://www.510kdatabase.net/k913730/ 1992-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k913730-aesculap-titanium-bone-plates-fda-510k.jpg K913730 - AESCULAP TITANIUM BONE PLATES K913730 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aesculap, Inc.. Cleared Mar 1992. https://www.510kdatabase.net/k915390/ 1992-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k915390-3-lead-extension-with-2-interlink-fda-510k.jpg K915390 - 3 LEAD EXTENSION WITH 2 INTERLINK INJECTION SITES K915390 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 1992. https://www.510kdatabase.net/k912629/ 1992-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k912629-datascope-system-95-fda-510k.jpg K912629 - DATASCOPE SYSTEM 95 K912629 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Mar 1992. https://www.510kdatabase.net/k913765/ 1992-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k913765-yasargil-aneurysm-clips-modification-fda-510k.jpg K913765 - YASARGIL ANEURYSM CLIPS, MODIFICATION K913765 is a FDA 510(k) cleared neurology medical device. Manufacturer: Aesculap, Inc.. Cleared Mar 1992. https://www.510kdatabase.net/k913847/ 1992-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k913847-system-90-and-system-90t-fda-510k.jpg K913847 - SYSTEM 90 AND SYSTEM 90T K913847 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Mar 1992. https://www.510kdatabase.net/k914456/ 1992-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k914456-dentacolorr-cre-active-fda-510k.jpg K914456 - DENTACOLOR(R) CRE-ACTIVE K914456 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Mar 1992. https://www.510kdatabase.net/k914877/ 1992-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k914877-il-testtm-urea-nitrogen-fda-510k.jpg K914877 - IL TEST(TM) UREA NITROGEN K914877 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Mar 1992. https://www.510kdatabase.net/k915096/ 1992-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k915096-neurofax-eeg-5532-fda-510k.jpg K915096 - NEUROFAX EEG 5532 K915096 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Mar 1992. https://www.510kdatabase.net/k915596/ 1992-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k915596-biomodular-shoulder-humeral-head-w-fda-510k.jpg K915596 - BIOMODULAR SHOULDER HUMERAL HEAD W/ IONGUARD K915596 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Mar 1992. https://www.510kdatabase.net/k915680/ 1992-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k915680-amerlite-processing-center-fda-510k.jpg K915680 - AMERLITE PROCESSING CENTER K915680 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Mar 1992. https://www.510kdatabase.net/k920008/ 1992-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k920008-il-test-immunoglobulin-m-igm-fda-510k.jpg K920008 - IL TEST IMMUNOGLOBULIN M (IGM) K920008 is a FDA 510(k) cleared immunology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Mar 1992. https://www.510kdatabase.net/k920337/ 1992-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k920337-miles-lipase-sera-pak-method-fda-510k.jpg K920337 - MILES LIPASE SERA-PAK METHOD K920337 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Mar 1992. https://www.510kdatabase.net/k920419/ 1992-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k920419-il-test-dat-calcontrol-set-de-fda-510k.jpg K920419 - IL TEST DAT CAL/CONTROL SET D/E K920419 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Mar 1992. https://www.510kdatabase.net/k915548/ 1992-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k915548-ionguard-titanium-modular-heads-fda-510k.jpg K915548 - IONGUARD TITANIUM MODULAR HEADS K915548 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Mar 1992. https://www.510kdatabase.net/k914995/ 1992-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k914995-cordis-straight-ventricular-catheter-fda-510k.jpg K914995 - CORDIS STRAIGHT VENTRICULAR CATHETER K914995 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cordis Corp.. Cleared Mar 1992. https://www.510kdatabase.net/k915544/ 1992-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k915544-laparoscopy-scissors-fda-510k.jpg K915544 - LAPAROSCOPY SCISSORS K915544 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 1992. https://www.510kdatabase.net/k913997/ 1992-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k913997-saecg-cardiograph-model-m1754a-fda-510k.jpg K913997 - SAECG CARDIOGRAPH MODEL M1754A K913997 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Mar 1992. https://www.510kdatabase.net/k914375/ 1992-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k914375-non-weighted-polyurethane-enteral-fda-510k.jpg K914375 - NON-WEIGHTED POLYURETHANE ENTERAL FEEDING TUBE K914375 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Sherwood Medical Co.. Cleared Mar 1992. https://www.510kdatabase.net/k915499/ 1992-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k915499-flo-gard-8000-half-set-fda-510k.jpg K915499 - FLO-GARD 8000 HALF-SET K915499 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 1992. https://www.510kdatabase.net/k920199/ 1992-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k920199-head-coil-geometric-distor-spec-for-fda-510k.jpg K920199 - HEAD COIL GEOMETRIC DISTOR SPEC FOR VISTA HPQ SYST K920199 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Mar 1992. https://www.510kdatabase.net/k913258/ 1992-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k913258-disposable-introsseous-infusion-needles-fda-510k.jpg K913258 - DISPOSABLE INTROSSEOUS INFUSION NEEDLES K913258 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cook, Inc.. Cleared Mar 1992. https://www.510kdatabase.net/k913505/ 1992-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k913505-enzygnost-toxoplasmosisigm-fda-510k.jpg K913505 - ENZYGNOST TOXOPLASMOSIS/IGM K913505 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Mar 1992. https://www.510kdatabase.net/k913931/ 1992-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k913931-pancretec-providerr-model-5500-infus-fda-510k.jpg K913931 - PANCRETEC PROVIDER(R) MODEL 5500 INFUS PUMP, MODIF K913931 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1992. https://www.510kdatabase.net/k914949/ 1992-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k914949-coagulation-arprcatno5185-fda-510k.jpg K914949 - COAGULATION ARPR,CAT.NO.5185 K914949 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Mar 1992. https://www.510kdatabase.net/k915409/ 1992-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k915409-intraosseous-access-needle-fda-510k.jpg K915409 - INTRAOSSEOUS ACCESS NEEDLE K915409 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cook, Inc.. Cleared Mar 1992. https://www.510kdatabase.net/k915462/ 1992-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k915462-fibrinogen-control-fda-510k.jpg K915462 - FIBRINOGEN CONTROL K915462 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Mar 1992. https://www.510kdatabase.net/k920336/ 1992-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k920336-miles-aspartate-aminotransferase-sera-fda-510k.jpg K920336 - MILES ASPARTATE AMINOTRANSFERASE SERA-PAK METHOD K920336 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Mar 1992. https://www.510kdatabase.net/k914728/ 1992-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k914728-kodak-ektascan-imagelink-ultrasound-fda-510k.jpg K914728 - KODAK EKTASCAN IMAGELINK ULTRASOUND SYSTEM K914728 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Mar 1992. https://www.510kdatabase.net/k915774/ 1992-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k915774-prolene-polypropylene-mesh-plug-w-fda-510k.jpg K915774 - PROLENE POLYPROPYLENE MESH PLUG W/ ONLAY PATCH K915774 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Mar 1992. https://www.510kdatabase.net/k915830/ 1992-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k915830-prisma-universal-bondr-3-fda-510k.jpg K915830 - PRISMA UNIVERSAL BOND(R) 3 K915830 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Mar 1992. https://www.510kdatabase.net/k920124/ 1992-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k920124-turbiquant-fda-510k.jpg K920124 - TURBIQUANT K920124 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Mar 1992. https://www.510kdatabase.net/k920247/ 1992-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k920247-amerlite-mab-ft4-assay-fda-510k.jpg K920247 - AMERLITE MAB FT4 ASSAY K920247 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Mar 1992. https://www.510kdatabase.net/k920583/ 1992-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k920583-abbott-quickstart-amylase-5axx-fda-510k.jpg K920583 - ABBOTT QUICKSTART AMYLASE, #5AXX K920583 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Mar 1992. https://www.510kdatabase.net/k915522/ 1992-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k915522-flo-gardr-6201-fda-510k.jpg K915522 - FLO-GARD(R) 6201 K915522 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Feb 1992. https://www.510kdatabase.net/k915523/ 1992-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k915523-flo-gardr-6301-fda-510k.jpg K915523 - FLO-GARD(R) 6301 K915523 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Feb 1992. https://www.510kdatabase.net/k913693/ 1992-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k913693-enzygnostr-anti-cmvigm-fda-510k.jpg K913693 - ENZYGNOST(R) ANTI-CMV/IGM K913693 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Feb 1992. https://www.510kdatabase.net/k914305/ 1992-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k914305-sytec-dentascan-fda-510k.jpg K914305 - SYTEC DENTASCAN K914305 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Feb 1992. https://www.510kdatabase.net/k915496/ 1992-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k915496-deseret-guidewire-introducer-fda-510k.jpg K915496 - DESERET GUIDEWIRE INTRODUCER K915496 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Feb 1992. https://www.510kdatabase.net/k920418/ 1992-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k920418-il-test-cannabinoid-35282-fda-510k.jpg K920418 - IL TEST CANNABINOID, 35282 K920418 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Feb 1992. https://www.510kdatabase.net/k920507/ 1992-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k920507-emit-ii-monoclonal-amphetamine-fda-510k.jpg K920507 - EMIT II MONOCLONAL AMPHETAMINE/ METHAMPH. ASSAY K920507 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Feb 1992. https://www.510kdatabase.net/k912685/ 1992-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k912685-mem-4204-4-8-meb-4204-4208-evoke-fda-510k.jpg K912685 - MEM-4204-4-8, MEB-4204 &4208 EVOKE POTENT MEAS SYS K912685 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Feb 1992. https://www.510kdatabase.net/k915337/ 1992-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k915337-capiox-level-alarm-fda-510k.jpg K915337 - CAPIOX LEVEL ALARM K915337 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Feb 1992. https://www.510kdatabase.net/k915553/ 1992-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k915553-uscir-hemaflextm-introducer-with-coating-fda-510k.jpg K915553 - USCI(R) HEMAFLEX(TM) INTRODUCER WITH COATING K915553 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Feb 1992. https://www.510kdatabase.net/k913842/ 1992-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k913842-cordis-right-angle-catheter-guide-fda-510k.jpg K913842 - CORDIS RIGHT-ANGLE CATHETER GUIDE K913842 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cordis Corp.. Cleared Feb 1992. https://www.510kdatabase.net/k915304/ 1992-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k915304-abbott-smart-cap-fda-510k.jpg K915304 - ABBOTT SMART CAP K915304 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Abbott Laboratories. Cleared Feb 1992. https://www.510kdatabase.net/k913744/ 1992-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k913744-il-testtm-amlylase-fda-510k.jpg K913744 - IL TEST(TM) AMLYLASE K913744 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Feb 1992. https://www.510kdatabase.net/k914371/ 1992-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k914371-universal-femoral-nail-fda-510k.jpg K914371 - UNIVERSAL FEMORAL NAIL K914371 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Feb 1992. https://www.510kdatabase.net/k914453/ 1992-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k914453-universal-tibial-nail-and-unreamed-fda-510k.jpg K914453 - UNIVERSAL TIBIAL NAIL AND UNREAMED TIBIAL NAIL K914453 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Feb 1992. https://www.510kdatabase.net/k915380/ 1992-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k915380-microprotein-pr-fda-510k.jpg K915380 - MICROPROTEIN-PR K915380 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Feb 1992. https://www.510kdatabase.net/k915501/ 1992-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k915501-emit-dau-benzodiazepine-assay-fda-510k.jpg K915501 - EMIT D.A.U BENZODIAZEPINE ASSAY K915501 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Feb 1992. https://www.510kdatabase.net/k915724/ 1992-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k915724-model-6984m-lead-extender-kit-fda-510k.jpg K915724 - MODEL 6984M LEAD EXTENDER KIT K915724 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Feb 1992. https://www.510kdatabase.net/k920047/ 1992-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k920047-imx-estradiol-fda-510k.jpg K920047 - IMX ESTRADIOL K920047 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Feb 1992. https://www.510kdatabase.net/k920230/ 1992-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k920230-affinity-prg-fda-510k.jpg K920230 - AFFINITY PRG K920230 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Feb 1992. https://www.510kdatabase.net/k914832/ 1992-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k914832-surgical-apparel-fda-510k.jpg K914832 - SURGICAL APPAREL K914832 is a FDA 510(k) cleared general hospital medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Feb 1992. https://www.510kdatabase.net/k915186/ 1992-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k915186-7000-series-total-knee-patellar-fda-510k.jpg K915186 - 7000 SERIES TOTAL KNEE PATELLAR COMPONENTS K915186 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Feb 1992. https://www.510kdatabase.net/k915192/ 1992-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k915192-7000-series-modular-tibial-components-fda-510k.jpg K915192 - 7000 SERIES MODULAR TIBIAL COMPONENTS K915192 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Feb 1992. https://www.510kdatabase.net/k915195/ 1992-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k915195-enzymun-test-tsh-fda-510k.jpg K915195 - ENZYMUN-TEST TSH K915195 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Feb 1992. https://www.510kdatabase.net/k915374/ 1992-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k915374-cordis-6-french-0062-id-ptca-guiding-fda-510k.jpg K915374 - CORDIS 6 FRENCH 0.062 I.D. PTCA GUIDING CATHTER K915374 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Feb 1992. https://www.510kdatabase.net/k915418/ 1992-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k915418-ellagic-acid-aptt-reagent-fda-510k.jpg K915418 - ELLAGIC ACID APTT REAGENT K915418 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Feb 1992. https://www.510kdatabase.net/k920078/ 1992-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k920078-affinity-b12-fda-510k.jpg K920078 - AFFINITY B12 K920078 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Feb 1992. https://www.510kdatabase.net/k920031/ 1992-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k920031-kodak-x-omatic-ident-camera-fda-510k.jpg K920031 - KODAK X-OMATIC IDENT. CAMERA MAMMOGRAPHY UPGRADE K920031 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Feb 1992. https://www.510kdatabase.net/k912464/ 1992-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k912464-permanent-cardiac-pacing-leads-and-fda-510k.jpg K912464 - PERMANENT CARDIAC PACING LEADS AND ADAPTORS K912464 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Feb 1992. https://www.510kdatabase.net/k915124/ 1992-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k915124-universal-compresion-screw-fda-510k.jpg K915124 - UNIVERSAL COMPRESION SCREW K915124 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Feb 1992. https://www.510kdatabase.net/k915132/ 1992-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k915132-mck-maximum-congruent-knee-knee-system-fda-510k.jpg K915132 - MCK MAXIMUM CONGRUENT KNEE) KNEE SYSTEM K915132 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Feb 1992. https://www.510kdatabase.net/k915216/ 1992-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k915216-solution-system-cup-fda-510k.jpg K915216 - SOLUTION SYSTEM CUP K915216 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Feb 1992. https://www.510kdatabase.net/k915777/ 1992-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k915777-cordis-shuttle-catheter-fda-510k.jpg K915777 - CORDIS SHUTTLE CATHETER K915777 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Feb 1992. https://www.510kdatabase.net/k915836/ 1992-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k915836-cordis-50-french-super-torque-catheters-fda-510k.jpg K915836 - CORDIS 5.0 FRENCH SUPER TORQUE CATHETERS K915836 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Feb 1992. https://www.510kdatabase.net/k913958/ 1992-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k913958-flexiflo-quantum-enteral-nutrition-pump-fda-510k.jpg K913958 - FLEXIFLO QUANTUM ENTERAL NUTRITION PUMP K913958 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Feb 1992. https://www.510kdatabase.net/k913993/ 1992-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k913993-medtronic-models-3982-abcd-stag-array-fda-510k.jpg K913993 - MEDTRONIC MODELS 3982 A,B,C&D STAG ARRAY RES LEADS K913993 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Feb 1992. https://www.510kdatabase.net/k914763/ 1992-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k914763-dermacare-synthetic-medical-glove-fda-510k.jpg K914763 - DERMACARE SYNTHETIC MEDICAL GLOVE K914763 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Feb 1992. https://www.510kdatabase.net/k913192/ 1992-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k913192-simultesttm-imk-lymphocyte-fda-510k.jpg K913192 - SIMULTEST(TM) IMK-LYMPHOCYTE K913192 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Feb 1992. https://www.510kdatabase.net/k914467/ 1992-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k914467-milenia-total-t3-fda-510k.jpg K914467 - MILENIA TOTAL T3 K914467 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Feb 1992. https://www.510kdatabase.net/k914890/ 1992-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k914890-nt-protein-control-uy-fda-510k.jpg K914890 - N/T PROTEIN CONTROL UY K914890 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Feb 1992. https://www.510kdatabase.net/k920131/ 1992-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k920131-clarithromycin-15mcg-sensi-disc-fda-510k.jpg K920131 - CLARITHROMYCIN 15MCG SENSI DISC K920131 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Feb 1992. https://www.510kdatabase.net/k913487/ 1992-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k913487-riwolith-2280-fda-510k.jpg K913487 - RIWOLITH 2280 K913487 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Feb 1992. https://www.510kdatabase.net/k913994/ 1992-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k913994-monarchtm-inflation-syringe-fda-510k.jpg K913994 - MONARCH(TM) INFLATION SYRINGE K913994 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Feb 1992. https://www.510kdatabase.net/k914376/ 1992-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k914376-dxs-digital-x-ray-subtraction-fda-510k.jpg K914376 - DXS DIGITAL X-RAY SUBTRACTION K914376 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Feb 1992. https://www.510kdatabase.net/k915414/ 1992-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k915414-terumo-angiogtaphic-catheter-fda-510k.jpg K915414 - TERUMO ANGIOGTAPHIC CATHETER K915414 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Feb 1992. https://www.510kdatabase.net/k914968/ 1992-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k914968-disposable-trocar-sleeve-with-dilating-fda-510k.jpg K914968 - DISPOSABLE TROCAR SLEEVE WITH DILATING OBTURATOR K914968 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ethicon, Inc.. Cleared Feb 1992. https://www.510kdatabase.net/k915336/ 1992-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k915336-twinlook-fda-510k.jpg K915336 - TWINLOOK K915336 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Feb 1992. https://www.510kdatabase.net/k915572/ 1992-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k915572-becton-dickinson-modified-menghini-fda-510k.jpg K915572 - BECTON DICKINSON MODIFIED MENGHINI NEEDLE K915572 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Feb 1992. https://www.510kdatabase.net/k915355/ 1992-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k915355-ads-gel-and-insulating-gel-fda-510k.jpg K915355 - ADS-GEL AND INSULATING-GEL K915355 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Jan 1992. https://www.510kdatabase.net/k915489/ 1992-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k915489-auto-suture-absorable-subcuticular-fda-510k.jpg K915489 - AUTO SUTURE ABSORABLE SUBCUTICULAR CLOSURE STAPLE K915489 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Jan 1992. https://www.510kdatabase.net/k914885/ 1992-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k914885-beckman-synchrontm-micro-total-protein-fda-510k.jpg K914885 - BECKMAN SYNCHRON(TM) (MICRO) TOTAL PROTEIN TEST K914885 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jan 1992. https://www.510kdatabase.net/k915769/ 1992-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k915769-modified-memorytrace-er-model-4221-ecg-fda-510k.jpg K915769 - MODIFIED MEMORYTRACE ER MODEL 4221 ECG MONITOR K915769 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jan 1992. https://www.510kdatabase.net/k915806/ 1992-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k915806-milenia-data-reduction-fda-510k.jpg K915806 - MILENIA DATA REDUCTION K915806 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jan 1992. https://www.510kdatabase.net/k910850/ 1992-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k910850-psf-50et-fda-510k.jpg K910850 - PSF-50ET K910850 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Jan 1992. https://www.510kdatabase.net/k915084/ 1992-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k915084-beckman-sychrontm-triglycerides-reagent-fda-510k.jpg K915084 - BECKMAN SYCHRON(TM) TRIGLYCERIDES REAGENT K915084 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jan 1992. https://www.510kdatabase.net/k915516/ 1992-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k915516-abuscreen-online-cannabinoids-positive-fda-510k.jpg K915516 - ABUSCREEN ONLINE CANNABINOIDS POSITIVE CONTROL K915516 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jan 1992. https://www.510kdatabase.net/k913341/ 1992-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k913341-bardr-coude-tip-temperature-sensing-fda-510k.jpg K913341 - BARD(R) COUDE TIP TEMPERATURE SENSING CATHETER K913341 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 1992. https://www.510kdatabase.net/k914815/ 1992-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k914815-il-testtm-benzodiazepine-fda-510k.jpg K914815 - IL TEST(TM) BENZODIAZEPINE K914815 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jan 1992. https://www.510kdatabase.net/k915465/ 1992-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k915465-digitoxin-fpia-reagent-set-fda-510k.jpg K915465 - DIGITOXIN FPIA REAGENT SET K915465 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Jan 1992. https://www.510kdatabase.net/k915478/ 1992-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k915478-sensicare-synthetic-medical-gloves-fda-510k.jpg K915478 - SENSICARE SYNTHETIC MEDICAL GLOVES K915478 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jan 1992. https://www.510kdatabase.net/k915701/ 1992-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k915701-kodak-surecelltm-hcg-urine-test-fda-510k.jpg K915701 - KODAK SURECELL(TM) HCG URINE TEST KIT/MODIFICATION K915701 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Jan 1992. https://www.510kdatabase.net/k915728/ 1992-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k915728-emit-dau-phencyclidine-assay-fda-510k.jpg K915728 - EMIT D.A.U. PHENCYCLIDINE ASSAY K915728 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Jan 1992. https://www.510kdatabase.net/k913210/ 1992-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k913210-m-kurosakatm-fixation-screw-fda-510k.jpg K913210 - M. KUROSAKA(TM) FIXATION SCREW K913210 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jan 1992. https://www.510kdatabase.net/k913485/ 1992-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k913485-ct-sytec-8000-fda-510k.jpg K913485 - CT SYTEC 8000 K913485 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jan 1992. https://www.510kdatabase.net/k913673/ 1992-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k913673-vectra-magnetic-resonance-system-fda-510k.jpg K913673 - VECTRA MAGNETIC RESONANCE SYSTEM K913673 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jan 1992. https://www.510kdatabase.net/k915395/ 1992-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k915395-magnetic-resonane-diagnostic-device-fda-510k.jpg K915395 - MAGNETIC RESONANE DIAGNOSTIC DEVICE ACCESSORY K915395 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 1992. https://www.510kdatabase.net/k915463/ 1992-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k915463-activated-partial-thromboplastin-time-fda-510k.jpg K915463 - ACTIVATED PARTIAL THROMBOPLASTIN TIME K915463 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Jan 1992. https://www.510kdatabase.net/k913934/ 1992-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k913934-medtronic-model-3586-resume-lead-fda-510k.jpg K913934 - MEDTRONIC MODEL 3586 RESUME LEAD K913934 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Jan 1992. https://www.510kdatabase.net/k914909/ 1992-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k914909-il-testtm-calibration-set-sp-fda-510k.jpg K914909 - IL TEST(TM) CALIBRATION SET SP K914909 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jan 1992. https://www.510kdatabase.net/k915540/ 1992-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k915540-model-3587a-resume-ii-lead-fda-510k.jpg K915540 - MODEL 3587A RESUME II LEAD K915540 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Jan 1992. https://www.510kdatabase.net/k915335/ 1992-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k915335-silicoater-system-fda-510k.jpg K915335 - SILICOATER SYSTEM K915335 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Jan 1992. https://www.510kdatabase.net/k914993/ 1992-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k914993-il-testtm-transferrin-trf-fda-510k.jpg K914993 - IL TEST(TM) TRANSFERRIN (TRF) K914993 is a FDA 510(k) cleared immunology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jan 1992. https://www.510kdatabase.net/k915095/ 1992-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k915095-estiseal-lc-fda-510k.jpg K915095 - ESTISEAL LC K915095 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Jan 1992. https://www.510kdatabase.net/k915818/ 1992-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k915818-synthesr-titanium-small-reconstruction-fda-510k.jpg K915818 - SYNTHES(R) TITANIUM SMALL RECONSTRUCTION PLATE K915818 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jan 1992. https://www.510kdatabase.net/k910986/ 1992-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k910986-hoffmann-dynamic-wrist-fixator-fda-510k.jpg K910986 - HOFFMANN DYNAMIC WRIST FIXATOR K910986 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jan 1992. https://www.510kdatabase.net/k913420/ 1992-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k913420-zirconia-ceramic-modular-headstype-i-fda-510k.jpg K913420 - ZIRCONIA CERAMIC MODULAR HEADS(TYPE I TAPER) MODIF K913420 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jan 1992. https://www.510kdatabase.net/k913561/ 1992-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k913561-luque-segmental-spinal-instrumentation-fda-510k.jpg K913561 - LUQUE SEGMENTAL SPINAL INSTRUMENTATION K913561 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jan 1992. https://www.510kdatabase.net/k914558/ 1992-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k914558-traumafix-tm-external-fixator-fda-510k.jpg K914558 - TRAUMAFIX (TM) EXTERNAL FIXATOR K914558 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Jan 1992. https://www.510kdatabase.net/k914694/ 1992-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k914694-sterile-viewtm-hi-effic-helmetback-pk-fda-510k.jpg K914694 - STERILE VIEW(TM) HI EFFIC HELMET/BACK PK SUP/EXHAU K914694 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Depuy, Inc.. Cleared Jan 1992. https://www.510kdatabase.net/k914695/ 1992-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k914695-global-total-shoulder-fda-510k.jpg K914695 - GLOBAL TOTAL SHOULDER K914695 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jan 1992. https://www.510kdatabase.net/k915581/ 1992-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k915581-codman-sofwire-tm-kit-fda-510k.jpg K915581 - CODMAN SOF'WIRE (TM) KIT K915581 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Jan 1992. https://www.510kdatabase.net/k915692/ 1992-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k915692-cannulated-drill-bit-fda-510k.jpg K915692 - CANNULATED DRILL BIT K915692 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Jan 1992. https://www.510kdatabase.net/k913308/ 1992-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k913308-ivex-tpn-extension-filter-set-fda-510k.jpg K913308 - IVEX-TPN EXTENSION FILTER SET K913308 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Jan 1992. https://www.510kdatabase.net/k915239/ 1992-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k915239-endopath-disposable-trocar-sleeve-fda-510k.jpg K915239 - ENDOPATH DISPOSABLE TROCAR SLEEVE W/DILATING OBTUR K915239 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Jan 1992. https://www.510kdatabase.net/k915255/ 1992-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k915255-cditm-300-400-100-modification-fda-510k.jpg K915255 - CDI(TM) 300, 400 & 100, MODIFICATION K915255 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: 3M Company. Cleared Jan 1992. https://www.510kdatabase.net/k915265/ 1992-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k915265-cditm-hs-cuvette-modification-fda-510k.jpg K915265 - CDI(TM) H/S CUVETTE, MODIFICATION K915265 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: 3M Company. Cleared Jan 1992. https://www.510kdatabase.net/k915464/ 1992-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k915464-digitoxin-fpia-calibrator-set-fda-510k.jpg K915464 - DIGITOXIN FPIA CALIBRATOR SET K915464 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Jan 1992. https://www.510kdatabase.net/k915732/ 1992-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k915732-abbott-quickstart-tiglycerides-reagent-fda-510k.jpg K915732 - ABBOTT QUICKSTART TIGLYCERIDES REAGENT K915732 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jan 1992. https://www.510kdatabase.net/k904940/ 1992-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k904940-olympus-infant-resectoscope-and-fda-510k.jpg K904940 - OLYMPUS INFANT RESECTOSCOPE AND ACCESSORIES K904940 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Corp.. Cleared Jan 1992. https://www.510kdatabase.net/k914574/ 1992-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k914574-exactech-ceramic-femoral-head-component-fda-510k.jpg K914574 - EXACTECH CERAMIC FEMORAL HEAD COMPONENT K914574 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Jan 1992. https://www.510kdatabase.net/k914676/ 1992-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k914676-zimmerr-ceramic-femoral-heads-28mm-fda-510k.jpg K914676 - ZIMMER(R) CERAMIC FEMORAL HEADS 28MM DIAMETER K914676 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jan 1992. https://www.510kdatabase.net/k914946/ 1992-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k914946-cascade-480tm-auto-coag-analyzer-fda-510k.jpg K914946 - CASCADE 480(TM) AUTO COAG ANALYZER, MODIFICATION K914946 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Jan 1992. https://www.510kdatabase.net/k915151/ 1992-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k915151-auto-suture-modified-polymer-skin-fda-510k.jpg K915151 - AUTO SUTURE MODIFIED POLYMER SKIN GRAFT STAPLE K915151 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Jan 1992. https://www.510kdatabase.net/k911915/ 1992-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k911915-hemoclip-ii-fda-510k.jpg K911915 - HEMOCLIP II K911915 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Jan 1992. https://www.510kdatabase.net/k914255/ 1992-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k914255-liquichekr-unassayed-chemistry-fda-510k.jpg K914255 - LIQUICHEK(R) UNASSAYED CHEMISTRY CONTR(HUMAN) 1&2 K914255 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Jan 1992. https://www.510kdatabase.net/k914811/ 1992-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k914811-il-testtm-hdl-cholesterol-fda-510k.jpg K914811 - IL TEST(TM) HDL CHOLESTEROL K914811 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jan 1992. https://www.510kdatabase.net/k914972/ 1992-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k914972-carpentier-edwardsr-flex-annul-ring-fda-510k.jpg K914972 - CARPENTIER-EDWARDS(R) FLEX ANNUL RING, 4500 TRICUS K914972 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jan 1992. https://www.510kdatabase.net/k914901/ 1992-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k914901-vacutainer-kit-fda-510k.jpg K914901 - VACUTAINER KIT K914901 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jan 1992. https://www.510kdatabase.net/k915213/ 1992-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k915213-corvac-blood-collection-tube-fda-510k.jpg K915213 - CORVAC BLOOD COLLECTION TUBE K915213 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sherwood Medical Co.. Cleared Jan 1992. https://www.510kdatabase.net/k904939/ 1992-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k904939-flexible-and-rigid-ureterotome-system-fda-510k.jpg K904939 - FLEXIBLE AND RIGID URETEROTOME SYSTEM K904939 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Corp.. Cleared Jan 1992. https://www.510kdatabase.net/k915480/ 1992-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k915480-b-d-ultra-vue-procedure-needle-w-fda-510k.jpg K915480 - B-D ULTRA-VUE PROCEDURE NEEDLE W/ SPINAL TYPE PT. K915480 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jan 1992. https://www.510kdatabase.net/k915481/ 1992-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k915481-b-d-ultra-vue-procedure-needle-w-chiba-fda-510k.jpg K915481 - B-D ULTRA-VUE PROCEDURE NEEDLE W/ CHIBA TYPE POINT K915481 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jan 1992. https://www.510kdatabase.net/k915482/ 1992-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k915482-b-d-ultra-vue-procedure-needle-w-fda-510k.jpg K915482 - B-D ULTRA-VUE PROCEDURE NEEDLE W/ WESTCOTT TYPE PT K915482 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jan 1992. https://www.510kdatabase.net/k913418/ 1992-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k913418-senographe-dmrsmrdm-fda-510k.jpg K913418 - SENOGRAPHE DMR/SMR/DM K913418 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jan 1992. https://www.510kdatabase.net/k914143/ 1992-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k914143-kodak-x-omat-480-ra-processor-fda-510k.jpg K914143 - KODAK X-OMAT 480 RA PROCESSOR K914143 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Jan 1992. https://www.510kdatabase.net/k914463/ 1992-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k914463-abbott-quickstart-sgot-item-number-5a42-fda-510k.jpg K914463 - ABBOTT QUICKSTART SGOT, ITEM NUMBER: 5A42 K914463 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jan 1992. https://www.510kdatabase.net/k911802/ 1992-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k911802-pmi-patient-matched-implants-hip-fda-510k.jpg K911802 - PMI (PATIENT MATCHED IMPLANTS) HIP FEMORAL COMP K911802 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jan 1992. https://www.510kdatabase.net/k913315/ 1992-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k913315-bio-rad-total-protein-test-kit-fda-510k.jpg K913315 - BIO-RAD TOTAL PROTEIN TEST KIT K913315 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Jan 1992. https://www.510kdatabase.net/k910665/ 1991-12-31 monthly 0.5 https://www.510kdatabase.net/og-image/k910665-model-556-monitor-w24-hr-trend-fda-510k.jpg K910665 - MODEL 556 MONITOR W/24-HR. TREND RECALL/MODIFIED K910665 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Dec 1991. https://www.510kdatabase.net/k914903/ 1991-12-31 monthly 0.5 https://www.510kdatabase.net/og-image/k914903-quickstart-urea-nitrogen-fda-510k.jpg K914903 - QUICKSTART UREA NITROGEN K914903 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Dec 1991. https://www.510kdatabase.net/k913262/ 1991-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k913262-aesculap-surgical-accessories-fda-510k.jpg K913262 - AESCULAP SURGICAL ACCESSORIES K913262 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Dec 1991. https://www.510kdatabase.net/k911702/ 1991-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k911702-olympus-retractable-valvulotome-fda-510k.jpg K911702 - OLYMPUS RETRACTABLE VALVULOTOME K911702 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Olympus Corp.. Cleared Dec 1991. https://www.510kdatabase.net/k913770/ 1991-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k913770-advantage-vs-ctmr-rad-diagnostic-fda-510k.jpg K913770 - ADVANTAGE V.S. CT/MR RAD DIAGNOSTIC WORKSTATION K913770 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Dec 1991. https://www.510kdatabase.net/k914777/ 1991-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k914777-sigma-procedure-no-333-uv-fda-510k.jpg K914777 - SIGMA PROCEDURE NO. 333-UV K914777 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Dec 1991. https://www.510kdatabase.net/k915112/ 1991-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k915112-magnetom-42-sp63-spimpact-fda-510k.jpg K915112 - MAGNETOM 42 SP,63 SP,IMPACT K915112 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Dec 1991. https://www.510kdatabase.net/k914433/ 1991-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k914433-medtronic-mdls-34873487a35873587a-scs-fda-510k.jpg K914433 - MEDTRONIC MDLS 3487/3487A/3587/3587A SCS LEADS K914433 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Dec 1991. https://www.510kdatabase.net/k912712/ 1991-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k912712-biomet-modular-total-hip-femoral-fda-510k.jpg K912712 - BIOMET MODULAR TOTAL HIP FEMORAL COMPONENTS K912712 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Dec 1991. https://www.510kdatabase.net/k914406/ 1991-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k914406-pt-ii-distal-cement-spacer-fda-510k.jpg K914406 - PT II DISTAL CEMENT SPACER K914406 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Dec 1991. https://www.510kdatabase.net/k914617/ 1991-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k914617-catheter-ureteral-dilator-fda-510k.jpg K914617 - CATHETER, URETERAL DILATOR K914617 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Dec 1991. https://www.510kdatabase.net/k914349/ 1991-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k914349-provider-apm-infusion-pump-fda-510k.jpg K914349 - PROVIDER APM INFUSION PUMP K914349 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Dec 1991. https://www.510kdatabase.net/k914582/ 1991-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k914582-kodak-ektascan-1120-laser-printer-fda-510k.jpg K914582 - KODAK EKTASCAN 1120 LASER PRINTER K914582 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Dec 1991. https://www.510kdatabase.net/k914974/ 1991-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k914974-medtronic-model-9455-teletrace-iii-ecg-fda-510k.jpg K914974 - MEDTRONIC MODEL 9455 TELETRACE III ECG MONIT SYST K914974 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Dec 1991. https://www.510kdatabase.net/k915413/ 1991-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k915413-cat-250b-fda-510k.jpg K915413 - CAT-250B K915413 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Dec 1991. https://www.510kdatabase.net/k891411/ 1991-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k891411-gianturco-wallace-tracheobronchial-z-fda-510k.jpg K891411 - GIANTURCO-WALLACE TRACHEOBRONCHIAL Z STENT K891411 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cook, Inc.. Cleared Dec 1991. https://www.510kdatabase.net/k904556/ 1991-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k904556-mansfield-cardiac-assist-model-940tm-iab-fda-510k.jpg K904556 - MANSFIELD CARDIAC ASSIST MODEL 940(TM) IAB K904556 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Boston Scientific Corp. Cleared Dec 1991. https://www.510kdatabase.net/k912498/ 1991-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k912498-the-karl-storz-26025uc-hamou-elec-fda-510k.jpg K912498 - THE KARL STORZ 26025UC HAMOU ELEC HYSTEROFLATOR K912498 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Dec 1991. https://www.510kdatabase.net/k913565/ 1991-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k913565-abbott-quickstart-cholesterol-test-fda-510k.jpg K913565 - ABBOTT QUICKSTART CHOLESTEROL TEST K913565 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Dec 1991. https://www.510kdatabase.net/k914208/ 1991-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k914208-merit-disposal-depottm-fda-510k.jpg K914208 - MERIT DISPOSAL DEPOT(TM) K914208 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Dec 1991. https://www.510kdatabase.net/k914502/ 1991-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k914502-bard-pca-ii-pump-with-program-cartridges-fda-510k.jpg K914502 - BARD PCA II PUMP WITH PROGRAM CARTRIDGES K914502 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 1991. https://www.510kdatabase.net/k914507/ 1991-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k914507-double-antibody-cannabionoidsquail-fda-510k.jpg K914507 - DOUBLE ANTIBODY CANNABIONOIDS/QUAIL DETER IN URINE K914507 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Dec 1991. https://www.510kdatabase.net/k914567/ 1991-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k914567-cordis-bipal-biopsy-forceps-fda-510k.jpg K914567 - CORDIS BIPAL BIOPSY FORCEPS K914567 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Dec 1991. https://www.510kdatabase.net/k914794/ 1991-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k914794-technicon-chem-1-plasma-glucose-fda-510k.jpg K914794 - TECHNICON CHEM 1 PLASMA GLUCOSE K914794 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Dec 1991. https://www.510kdatabase.net/k914863/ 1991-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k914863-cordis-cinchr-steerable-guidewire-ext-fda-510k.jpg K914863 - CORDIS CINCH(R) STEERABLE GUIDEWIRE EXT W/SLX COAT K914863 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Dec 1991. https://www.510kdatabase.net/k915077/ 1991-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k915077-synchron-creatinine-triggered-test-cx457-fda-510k.jpg K915077 - SYNCHRON CREATININE TRIGGERED TEST CX4,5,7, K915077 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Dec 1991. https://www.510kdatabase.net/k905552/ 1991-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k905552-laparolith-fda-510k.jpg K905552 - LAPAROLITH K905552 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Dec 1991. https://www.510kdatabase.net/k912398/ 1991-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k912398-endopath-surg-disp-trocarshieldunshielde-fda-510k.jpg K912398 - ENDOPATH SURG DISP TROCAR(SHIELD/UNSHIELDED),MODIF K912398 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ethicon, Inc.. Cleared Dec 1991. https://www.510kdatabase.net/k913384/ 1991-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k913384-columnmatetm-beta-thal-cat-no-4515-fda-510k.jpg K913384 - COLUMNMATE(TM) BETA-THAL CAT. NO. 4515 K913384 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Dec 1991. https://www.510kdatabase.net/k912103/ 1991-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k912103-lifeshield-extension-set-fda-510k.jpg K912103 - LIFESHIELD EXTENSION SET K912103 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Dec 1991. https://www.510kdatabase.net/k914361/ 1991-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k914361-creatine-kinase-mb-test-item-number-5a46-fda-510k.jpg K914361 - CREATINE KINASE MB TEST ITEM NUMBER 5A46 K914361 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Dec 1991. https://www.510kdatabase.net/k914917/ 1991-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k914917-du-pont-total-proteinalbumin-calibrator-fda-510k.jpg K914917 - DU PONT TOTAL PROTEIN/ALBUMIN CALIBRATOR K914917 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Dec 1991. https://www.510kdatabase.net/k913636/ 1991-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k913636-orbis-sigma-valve-system-for-fda-510k.jpg K913636 - ORBIS-SIGMA VALVE SYSTEM FOR VENTRICULAR SHUNTING K913636 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cordis Corp.. Cleared Dec 1991. https://www.510kdatabase.net/k911963/ 1991-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k911963-medtronic-model-90002065-mf-tens-system-fda-510k.jpg K911963 - MEDTRONIC MODEL 90002065 MF TENS SYSTEM K911963 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Dec 1991. https://www.510kdatabase.net/k912099/ 1991-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k912099-3m-fluid-control-system-small-joint-fda-510k.jpg K912099 - 3M FLUID CONTROL SYSTEM SMALL JOINT COPS CANNULA K912099 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 3M Company. Cleared Dec 1991. https://www.510kdatabase.net/k912744/ 1991-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k912744-org-8200a-universal-signal-housing-fda-510k.jpg K912744 - ORG-8200A UNIVERSAL SIGNAL HOUSING K912744 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Dec 1991. https://www.510kdatabase.net/k914029/ 1991-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k914029-esophageal-z-stent-fda-510k.jpg K914029 - ESOPHAGEAL Z-STENT K914029 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook, Inc.. Cleared Dec 1991. https://www.510kdatabase.net/k914186/ 1991-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k914186-ultracrowntm-pre-solder-fda-510k.jpg K914186 - ULTRACROWN(TM) PRE-SOLDER K914186 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Dec 1991. https://www.510kdatabase.net/k914693/ 1991-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k914693-depuy-nitino-guide-wire-fda-510k.jpg K914693 - DEPUY (NITINO) GUIDE WIRE K914693 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Dec 1991. https://www.510kdatabase.net/k915194/ 1991-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k915194-cedia-t4-fda-510k.jpg K915194 - CEDIA T4 K915194 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Dec 1991. https://www.510kdatabase.net/k914000/ 1991-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k914000-globaltm-total-shoulder-wdupont-fda-510k.jpg K914000 - GLOBAL(TM) TOTAL SHOULDER W/DUPONT ENHANCED UHMWPE K914000 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Dec 1991. https://www.510kdatabase.net/k914014/ 1991-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k914014-facstrak-flow-cytometer-fda-510k.jpg K914014 - FACSTRAK FLOW CYTOMETER K914014 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Dec 1991. https://www.510kdatabase.net/k914449/ 1991-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k914449-gore-texr-soft-tissue-patch-process-fda-510k.jpg K914449 - GORE-TEX(R) SOFT TISSUE PATCH, PROCESS CHANGE K914449 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Dec 1991. https://www.510kdatabase.net/k914549/ 1991-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k914549-ethicon-absorbable-suture-clip-and-fda-510k.jpg K914549 - ETHICON ABSORBABLE SUTURE CLIP AND APPLIER K914549 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Dec 1991. https://www.510kdatabase.net/k914742/ 1991-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k914742-myocard-protect-syst-wblood-cardio-fda-510k.jpg K914742 - MYOCARD PROTECT SYST W/BLOOD CARDIO HEAT EXC/MODIF K914742 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Dec 1991. https://www.510kdatabase.net/k914971/ 1991-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k914971-tec-8251a-defibrillator-monitor-fda-510k.jpg K914971 - TEC-8251A DEFIBRILLATOR MONITOR, MODIFICATION K914971 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Dec 1991. https://www.510kdatabase.net/k913737/ 1991-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k913737-il-testtm-cocaine-fda-510k.jpg K913737 - IL TEST(TM) COCAINE K913737 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Dec 1991. https://www.510kdatabase.net/k913355/ 1991-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k913355-luhr-pan-fixation-system-fda-510k.jpg K913355 - LUHR PAN FIXATION SYSTEM K913355 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Dec 1991. https://www.510kdatabase.net/k913614/ 1991-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k913614-fructosamine-abg21-test-system-fda-510k.jpg K913614 - FRUCTOSAMINE ABG21 TEST SYSTEM K913614 is a FDA 510(k) cleared hematology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Dec 1991. https://www.510kdatabase.net/k914328/ 1991-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k914328-mammomat-c3-and-3-mammographic-x-ray-fda-510k.jpg K914328 - MAMMOMAT C3 AND 3 MAMMOGRAPHIC X-RAY SYSTEM K914328 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Dec 1991. https://www.510kdatabase.net/k915088/ 1991-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k915088-kodak-min-r-identification-camera-fda-510k.jpg K915088 - KODAK MIN-R IDENTIFICATION CAMERA K915088 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Dec 1991. https://www.510kdatabase.net/k913106/ 1991-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k913106-abbott-imx-toxo-igm-positive-control-fda-510k.jpg K913106 - ABBOTT IMX TOXO IGM POSITIVE CONTROL K913106 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1991. https://www.510kdatabase.net/k913150/ 1991-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k913150-abbott-matrix-aero-plus-system-fda-510k.jpg K913150 - ABBOTT MATRIX AERO PLUS SYSTEM K913150 is a FDA 510(k) cleared immunology medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1991. https://www.510kdatabase.net/k913413/ 1991-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k913413-kangaroor-pettm-enteral-feed-fda-510k.jpg K913413 - KANGAROO(R) PET(TM) ENTERAL FEED PUMP/CHARGER BASE K913413 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Nov 1991. https://www.510kdatabase.net/k914151/ 1991-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k914151-il-testtm-digoxin-fda-510k.jpg K914151 - IL TEST(TM DIGOXIN K914151 is a FDA 510(k) cleared immunology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Nov 1991. https://www.510kdatabase.net/k914470/ 1991-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k914470-pneumo-sealtm-fda-510k.jpg K914470 - PNEUMO-SEAL(TM) K914470 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Nov 1991. https://www.510kdatabase.net/k914546/ 1991-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k914546-angled-blade-plate-fda-510k.jpg K914546 - ANGLED BLADE PLATE K914546 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Nov 1991. https://www.510kdatabase.net/k914973/ 1991-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k914973-syva-emit-dau-cocaine-metabolite-fda-510k.jpg K914973 - SYVA EMIT D.A.U. COCAINE METABOLITE K914973 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Nov 1991. https://www.510kdatabase.net/k915003/ 1991-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k915003-emit-calibrator-level-1cutofflevel-2high-fda-510k.jpg K915003 - EMIT CALIBRATOR LEVEL 1(CUTOFF)/LEVEL 2(HIGH) K915003 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Nov 1991. https://www.510kdatabase.net/k910991/ 1991-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k910991-shiley-therapeutic-autotransfusion-fda-510k.jpg K910991 - SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM K910991 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shiley, Inc.. Cleared Nov 1991. https://www.510kdatabase.net/k913807/ 1991-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k913807-repr-spe-template-30-16-8-fda-510k.jpg K913807 - REP(R) SPE TEMPLATE 30, 16, & 8 K913807 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Nov 1991. https://www.510kdatabase.net/k914048/ 1991-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k914048-needlelocktm-with-interlinktm-fda-510k.jpg K914048 - NEEDLE*LOCK(TM) WITH INTERLINK(TM) INJECTION SITE K914048 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Nov 1991. https://www.510kdatabase.net/k914116/ 1991-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k914116-plasma-tfe-synthetic-artery-fda-510k.jpg K914116 - PLASMA TFE SYNTHETIC ARTERY-CLARIFICATION K914116 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Nov 1991. https://www.510kdatabase.net/k914212/ 1991-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k914212-bard-singular-biopsy-forceps-fda-510k.jpg K914212 - BARD SINGULAR BIOPSY FORCEPS K914212 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 1991. https://www.510kdatabase.net/k914508/ 1991-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k914508-dimensionr-lactic-acid-method-fda-510k.jpg K914508 - DIMENSION(R) LACTIC ACID METHOD K914508 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Nov 1991. https://www.510kdatabase.net/k914511/ 1991-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k914511-technicon-axontm-system-methods-fda-510k.jpg K914511 - TECHNICON AXON(TM) SYSTEM METHODS ANYALYE HDL CHOL K914511 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Nov 1991. https://www.510kdatabase.net/k914888/ 1991-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k914888-technicon-chem-1tm-syst-gen2-syst-fda-510k.jpg K914888 - TECHNICON CHEM 1(TM) SYST (GEN2 SYST) K914888 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Nov 1991. https://www.510kdatabase.net/k913869/ 1991-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k913869-rf-opaque-blanket-for-magnetom-system-fda-510k.jpg K913869 - RF-OPAQUE BLANKET FOR MAGNETOM SYSTEM K913869 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 1991. https://www.510kdatabase.net/k913871/ 1991-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k913871-floswitchr-hp-fda-510k.jpg K913871 - FLOSWITCH(R) HP K913871 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Nov 1991. https://www.510kdatabase.net/k904798/ 1991-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k904798-suprapubic-flow-controller-fda-510k.jpg K904798 - SUPRAPUBIC FLOW CONTROLLER K904798 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Corp.. Cleared Nov 1991. https://www.510kdatabase.net/k912294/ 1991-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k912294-allergy-information-manager-fda-510k.jpg K912294 - ALLERGY INFORMATION MANAGER K912294 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Nov 1991. https://www.510kdatabase.net/k912764/ 1991-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k912764-medtronic-model-3861-temporary-fda-510k.jpg K912764 - MEDTRONIC MODEL 3861 TEMPORARY SCREENING LEAD KIT K912764 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Nov 1991. https://www.510kdatabase.net/k913442/ 1991-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k913442-medtronic-3625-screener-system-fda-510k.jpg K913442 - MEDTRONIC 3625 SCREENER SYSTEM K913442 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Nov 1991. https://www.510kdatabase.net/k913812/ 1991-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k913812-omnifitomniflexodcomnifit-ha-hip-stem-fda-510k.jpg K913812 - OMNIFIT/OMNIFLEX/ODC/OMNIFIT-HA HIP STEM SERIES K913812 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Nov 1991. https://www.510kdatabase.net/k913829/ 1991-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k913829-olympus-flexible-tip-thoracoscope-fda-510k.jpg K913829 - OLYMPUS FLEXIBLE TIP THORACOSCOPE K913829 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Olympus Corp.. Cleared Nov 1991. https://www.510kdatabase.net/k913921/ 1991-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k913921-abbott-quickstart-alka-phosphatase-alp-fda-510k.jpg K913921 - ABBOTT QUICKSTART ALKA PHOSPHATASE (ALP) ITEM#5A38 K913921 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Nov 1991. https://www.510kdatabase.net/k913996/ 1991-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k913996-computerized-tomography-x-ray-system-fda-510k.jpg K913996 - COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION K913996 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 1991. https://www.510kdatabase.net/k914018/ 1991-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k914018-abbott-quickstart-triglycerides-fda-510k.jpg K914018 - ABBOTT QUICKSTART TRIGLYCERIDES REAGENTS, #5A33 K914018 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Nov 1991. https://www.510kdatabase.net/k914025/ 1991-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k914025-technicon-axontm-systems-altp-5-pastp-fda-510k.jpg K914025 - TECHNICON AXON(TM) SYSTEMS, ALT(P 5-P)/AST(P 5-P) K914025 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Nov 1991. https://www.510kdatabase.net/k914170/ 1991-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k914170-liquichek-therapeutic-drug-monitoring-fda-510k.jpg K914170 - LIQUICHEK THERAPEUTIC DRUG MONITORING CONTROL(TDM) K914170 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bio-Rad. Cleared Nov 1991. https://www.510kdatabase.net/k914225/ 1991-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k914225-acar-beta-2-microglobulin-calibrator-fda-510k.jpg K914225 - ACA(R) BETA-2-MICROGLOBULIN CALIBRATOR K914225 is a FDA 510(k) cleared immunology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Nov 1991. https://www.510kdatabase.net/k914352/ 1991-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k914352-cordis-obturator-fda-510k.jpg K914352 - CORDIS OBTURATOR K914352 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Nov 1991. https://www.510kdatabase.net/k914460/ 1991-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k914460-medtronic-model-5407s-5807s-5410s-surg-fda-510k.jpg K914460 - MEDTRONIC MODEL 5407S, 5807S & 5410S SURG CABLES K914460 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Nov 1991. https://www.510kdatabase.net/k914464/ 1991-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k914464-abbott-quickstart-sgpt-item-number-5a43-fda-510k.jpg K914464 - ABBOTT QUICKSTART SGPT, ITEM NUMBER 5A43 K914464 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Nov 1991. https://www.510kdatabase.net/k914527/ 1991-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k914527-cequaltm-fda-510k.jpg K914527 - CEQUAL(TM) K914527 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Nov 1991. https://www.510kdatabase.net/k914547/ 1991-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k914547-laparobagtm-tissue-retrieval-system-fda-510k.jpg K914547 - LAPAROBAG(TM) TISSUE RETRIEVAL SYSTEM K914547 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Baxter Healthcare Corp. Cleared Nov 1991. https://www.510kdatabase.net/k914750/ 1991-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k914750-roche-cobasr-ammonia-and-ethanol-fda-510k.jpg K914750 - ROCHE COBAS(R) AMMONIA AND ETHANOL CALIBRATOR K914750 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Nov 1991. https://www.510kdatabase.net/k911400/ 1991-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k911400-walkaway-tm-40-fda-510k.jpg K911400 - WALKAWAY TM 40 K911400 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Nov 1991. https://www.510kdatabase.net/k911680/ 1991-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k911680-quanta-litetm-aca-fda-510k.jpg K911680 - QUANTA LITE(TM) ACA K911680 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Nov 1991. https://www.510kdatabase.net/k913827/ 1991-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k913827-model-7700a77010a77025a77030a77035a-fda-510k.jpg K913827 - MODEL 7700A/77010A/77025A/77030A/77035A ULTRA IMAG K913827 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Nov 1991. https://www.510kdatabase.net/k914226/ 1991-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k914226-acar-beta-2-microglobulin-b2m-test-pack-fda-510k.jpg K914226 - ACA(R) BETA-2-MICROGLOBULIN (B2M) TEST PACK K914226 is a FDA 510(k) cleared immunology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Nov 1991. https://www.510kdatabase.net/k914510/ 1991-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k914510-calciumlithium-test-beckman-synchron-fda-510k.jpg K914510 - CALCIUM/LITHIUM TEST BECKMAN SYNCHRON EL-ISE ANALY K914510 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Nov 1991. https://www.510kdatabase.net/k914525/ 1991-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k914525-flurospot-h-version-2-fda-510k.jpg K914525 - FLUROSPOT H VERSION 2 K914525 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 1991. https://www.510kdatabase.net/k914806/ 1991-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k914806-abuscreenr-ontrakr-positive-reference-fda-510k.jpg K914806 - ABUSCREEN(R) ONTRAK(R) POSITIVE REFERENCE CONTROL K914806 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Nov 1991. https://www.510kdatabase.net/k913682/ 1991-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k913682-merit-custom-kit-fda-510k.jpg K913682 - MERIT CUSTOM KIT K913682 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Nov 1991. https://www.510kdatabase.net/k913649/ 1991-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k913649-modular-calcar-replacement-fda-510k.jpg K913649 - MODULAR CALCAR REPLACEMENT K913649 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Nov 1991. https://www.510kdatabase.net/k913704/ 1991-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k913704-argebond-80-fda-510k.jpg K913704 - ARGEBOND 80 K913704 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Nov 1991. https://www.510kdatabase.net/k913860/ 1991-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k913860-ultracrowntm-pd-alloy-post-solder-fda-510k.jpg K913860 - ULTRACROWN(TM) PD ALLOY POST-SOLDER K913860 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Nov 1991. https://www.510kdatabase.net/k912404/ 1991-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k912404-transesophageal-transducer-thermal-fda-510k.jpg K912404 - TRANSESOPHAGEAL TRANSDUCER THERMAL SAFETY K912404 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Nov 1991. https://www.510kdatabase.net/k913533/ 1991-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k913533-model-m1403a-telemetry-monitoring-fda-510k.jpg K913533 - MODEL M1403A TELEMETRY MONITORING SYSTEMS (TMS) K913533 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Nov 1991. https://www.510kdatabase.net/k913738/ 1991-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k913738-il-testtm-amphetamine-fda-510k.jpg K913738 - IL TEST(TM) AMPHETAMINE K913738 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Nov 1991. https://www.510kdatabase.net/k913742/ 1991-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k913742-il-testtm-opiate-fda-510k.jpg K913742 - IL TEST(TM) OPIATE K913742 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Nov 1991. https://www.510kdatabase.net/k913743/ 1991-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k913743-il-testtm-phencyclidine-fda-510k.jpg K913743 - IL TEST(TM) PHENCYCLIDINE K913743 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Nov 1991. https://www.510kdatabase.net/k914472/ 1991-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k914472-spiked-washer-fda-510k.jpg K914472 - SPIKED WASHER K914472 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Nov 1991. https://www.510kdatabase.net/k910017/ 1991-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k910017-q4500-stree-test-monitor-fda-510k.jpg K910017 - Q4500 STREE TEST MONITOR K910017 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Nov 1991. https://www.510kdatabase.net/k910997/ 1991-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k910997-datascope-percor-stat-intra-aortic-fda-510k.jpg K910997 - DATASCOPE PERCOR STAT INTRA-AORTIC BALLOON K910997 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Nov 1991. https://www.510kdatabase.net/k913074/ 1991-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k913074-0016-guide-wire-for-neurological-fda-510k.jpg K913074 - 0.016 GUIDE WIRE FOR NEUROLOGICAL ENDOSCOPE K913074 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Nov 1991. https://www.510kdatabase.net/k913391/ 1991-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k913391-tegwire-tm-fda-510k.jpg K913391 - TEGWIRE (TM) K913391 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Nov 1991. https://www.510kdatabase.net/k913764/ 1991-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k913764-abbott-quickstart-magnesium-test-item-fda-510k.jpg K913764 - ABBOTT QUICKSTART MAGNESIUM TEST, ITEM #5A32 K913764 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Nov 1991. https://www.510kdatabase.net/k913786/ 1991-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k913786-flexiflo-over-the-guidewire-gast-kit-fda-510k.jpg K913786 - FLEXIFLO OVER-THE-GUIDEWIRE GAST KIT W/CR-BAR BUMP K913786 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1991. https://www.510kdatabase.net/k914165/ 1991-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k914165-x-ray-table-fda-510k.jpg K914165 - X-RAY TABLE K914165 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 1991. https://www.510kdatabase.net/k914447/ 1991-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k914447-gore-texr-vascular-grafts-process-change-fda-510k.jpg K914447 - GORE-TEX(R) VASCULAR GRAFTS, PROCESS CHANGE K914447 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Nov 1991. https://www.510kdatabase.net/k914448/ 1991-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k914448-gore-texr-cardiovascular-patch-process-fda-510k.jpg K914448 - GORE-TEX(R) CARDIOVASCULAR PATCH, PROCESS CHANGE K914448 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Nov 1991. https://www.510kdatabase.net/k914450/ 1991-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k914450-gore-texr-surgical-membrane-process-fda-510k.jpg K914450 - GORE-TEX(R) SURGICAL MEMBRANE, PROCESS CHANGE K914450 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Nov 1991. https://www.510kdatabase.net/k913911/ 1991-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k913911-abuscreenr-radioimmunoassay-for-fda-510k.jpg K913911 - ABUSCREEN(R) RADIOIMMUNOASSAY FOR METHAMPHE/AMPHET K913911 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Nov 1991. https://www.510kdatabase.net/k914509/ 1991-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k914509-abuscreenr-onlinetm-for-benzodiazepines-fda-510k.jpg K914509 - ABUSCREEN(R) ONLINE(TM) FOR BENZODIAZEPINES K914509 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Nov 1991. https://www.510kdatabase.net/k901186/ 1991-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k901186-monoclonal-antibody-anti-cd19-fda-510k.jpg K901186 - MONOCLONAL ANTIBODY ANTI-CD19 K901186 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Chemical Co.. Cleared Oct 1991. https://www.510kdatabase.net/k901187/ 1991-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k901187-monoclonal-antibody-anti-cd2-fda-510k.jpg K901187 - MONOCLONAL ANTIBODY ANTI-CD2 K901187 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Chemical Co.. Cleared Oct 1991. https://www.510kdatabase.net/k901188/ 1991-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k901188-monoclonal-antibody-anti-cd5-fda-510k.jpg K901188 - MONOCLONAL ANTIBODY ANTI-CD5 K901188 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Chemical Co.. Cleared Oct 1991. https://www.510kdatabase.net/k901189/ 1991-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k901189-monoclonal-antibody-anti-cd3-fda-510k.jpg K901189 - MONOCLONAL ANTIBODY ANTI-CD3 K901189 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Chemical Co.. Cleared Oct 1991. https://www.510kdatabase.net/k912807/ 1991-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k912807-abbott-quick-start-creatine-kinaseck-fda-510k.jpg K912807 - ABBOTT QUICK START CREATINE KINASE(CK) ITEM #5A17 K912807 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Oct 1991. https://www.510kdatabase.net/k913451/ 1991-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k913451-hewlett-packard-model-78720ac-fda-510k.jpg K913451 - HEWLETT-PACKARD MODEL 78720AC ARRHYTHMIA MONIT SYS K913451 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Oct 1991. https://www.510kdatabase.net/k911315/ 1991-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k911315-extracorporeal-blood-pumping-syst-for-fda-510k.jpg K911315 - EXTRACORPOREAL BLOOD PUMPING SYST FOR HEMOFILTRAT K911315 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Oct 1991. https://www.510kdatabase.net/k912030/ 1991-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k912030-cditm-2000-blood-gas-monitoring-syst-fda-510k.jpg K912030 - CDI(TM) 2000 BLOOD GAS MONITORING SYST, MODIFIED K912030 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: 3M Company. Cleared Oct 1991. https://www.510kdatabase.net/k912331/ 1991-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k912331-urs-hydro-dilator-model-number-216400-fda-510k.jpg K912331 - URS-HYDRO-DILATOR MODEL NUMBER 2164.00 K912331 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Oct 1991. https://www.510kdatabase.net/k913058/ 1991-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k913058-reptm-spe-temp-30-16-8-procedure-fda-510k.jpg K913058 - REP(TM) SPE TEMP-30-16-8 PROCEDURE, 3170,3171,3172 K913058 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Oct 1991. https://www.510kdatabase.net/k913475/ 1991-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k913475-magnetic-resonance-diagnostic-device-fda-510k.jpg K913475 - MAGNETIC RESONANCE DIAGNOSTIC DEVICE K913475 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Oct 1991. https://www.510kdatabase.net/k913718/ 1991-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k913718-pancretec-iv-model-5000-infus-device-fda-510k.jpg K913718 - PANCRETEC I.V. MODEL 5000 INFUS DEVICE, MODIFIED K913718 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1991. https://www.510kdatabase.net/k913719/ 1991-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k913719-pancretec-iv-model-5500-infuser-fda-510k.jpg K913719 - PANCRETEC I.V. MODEL 5500 INFUSER K913719 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1991. https://www.510kdatabase.net/k913720/ 1991-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k913720-pancretec-provider-one-infusion-system-fda-510k.jpg K913720 - PANCRETEC PROVIDER ONE INFUSION SYSTEM, MODIFIED K913720 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1991. https://www.510kdatabase.net/k914468/ 1991-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k914468-abuscreenr-onlinetm-for-barbiturates-fda-510k.jpg K914468 - ABUSCREEN(R) ONLINE(TM) FOR BARBITURATES K914468 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Oct 1991. https://www.510kdatabase.net/k913415/ 1991-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k913415-aesculap-titanium-bone-screws-fda-510k.jpg K913415 - AESCULAP TITANIUM BONE SCREWS K913415 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aesculap, Inc.. Cleared Oct 1991. https://www.510kdatabase.net/k912897/ 1991-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k912897-sceptor-identification-system-fda-510k.jpg K912897 - SCEPTOR IDENTIFICATION SYSTEM K912897 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1991. https://www.510kdatabase.net/k913466/ 1991-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k913466-abbott-quickstart-direct-bilirubin-fda-510k.jpg K913466 - ABBOTT QUICKSTART DIRECT BILIRUBIN (DBIL) #5A20 K913466 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Oct 1991. https://www.510kdatabase.net/k911756/ 1991-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k911756-posterior-nasal-epistaxis-instruments-fda-510k.jpg K911756 - POSTERIOR NASAL EPISTAXIS INSTRUMENTS K911756 is a FDA 510(k) cleared dental medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Oct 1991. https://www.510kdatabase.net/k912362/ 1991-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k912362-oes-thoracoscope-system-fda-510k.jpg K912362 - OES THORACOSCOPE SYSTEM K912362 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Olympus Corp.. Cleared Oct 1991. https://www.510kdatabase.net/k913525/ 1991-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k913525-mobile-x-ray-system-fda-510k.jpg K913525 - MOBILE X-RAY SYSTEM K913525 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 1991. https://www.510kdatabase.net/k914141/ 1991-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k914141-cordis-dual-lumen-pressure-monitoring-fda-510k.jpg K914141 - CORDIS DUAL LUMEN PRESSURE MONITORING CATHETER K914141 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Oct 1991. https://www.510kdatabase.net/k912492/ 1991-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k912492-evacuationirrigationelecrosurgical-fda-510k.jpg K912492 - EVACUATION/IRRIGATION/ELECROSURGICAL DEVICE K912492 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Oct 1991. https://www.510kdatabase.net/k913161/ 1991-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k913161-merit-manifold-fda-510k.jpg K913161 - MERIT MANIFOLD K913161 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Oct 1991. https://www.510kdatabase.net/k913740/ 1991-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k913740-il-testtm-dat-calcontrol-set-b-fda-510k.jpg K913740 - IL TEST(TM) DAT CAL/CONTROL SET B K913740 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Oct 1991. https://www.510kdatabase.net/k913741/ 1991-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k913741-il-testtm-dat-calcontrol-set-c-fda-510k.jpg K913741 - IL TEST(TM) DAT CAL/CONTROL SET C K913741 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Oct 1991. https://www.510kdatabase.net/k913895/ 1991-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k913895-flo-gardr-6200-6300-8000-fda-510k.jpg K913895 - FLO-GARD(R) 6200, 6300 & 8000 K913895 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Oct 1991. https://www.510kdatabase.net/k914074/ 1991-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k914074-8000-series-volumetric-pump-solution-set-fda-510k.jpg K914074 - 8000 SERIES VOLUMETRIC PUMP SOLUTION SET K914074 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Oct 1991. https://www.510kdatabase.net/k914261/ 1991-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k914261-abbott-quickstart-ld-15a30-fda-510k.jpg K914261 - ABBOTT QUICKSTART LD-1,#5A30 K914261 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Oct 1991. https://www.510kdatabase.net/k913245/ 1991-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k913245-model-80-hearing-aid-dispensing-system-fda-510k.jpg K913245 - MODEL 80 HEARING AID DISPENSING SYSTEM K913245 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: 3M Company. Cleared Oct 1991. https://www.510kdatabase.net/k913399/ 1991-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k913399-qbc-e-z-prep-fda-510k.jpg K913399 - QBC E-Z PREP K913399 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1991. https://www.510kdatabase.net/k914007/ 1991-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k914007-cordis-52-french-super-torque-plus-fda-510k.jpg K914007 - CORDIS 5.2 FRENCH SUPER TORQUE PLUS CARDIO CATH K914007 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Oct 1991. https://www.510kdatabase.net/k910693/ 1991-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k910693-pharmaseal-thoracentesis-tray-wuniv-fda-510k.jpg K910693 - PHARMASEAL THORACENTESIS TRAY W/UNIV DRAINAGE SET K910693 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Oct 1991. https://www.510kdatabase.net/k913288/ 1991-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k913288-medtronic-unipolar-poly-pac-lead-barr-fda-510k.jpg K913288 - MEDTRONIC UNIPOLAR, POLY PAC LEAD-BARR COAT COILS K913288 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Oct 1991. https://www.510kdatabase.net/k913802/ 1991-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k913802-auto-suturer-powered-endoscopic-giatm-fda-510k.jpg K913802 - AUTO SUTURE(R) POWERED ENDOSCOPIC GIA(TM) STAPLER K913802 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Oct 1991. https://www.510kdatabase.net/k913832/ 1991-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k913832-auto-suturer-powered-endoscopic-tar-fda-510k.jpg K913832 - AUTO SUTURE(R) POWERED ENDOSCOPIC TA(R) STAPLER K913832 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Oct 1991. https://www.510kdatabase.net/k913836/ 1991-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k913836-vlc-glass-ionomer-fda-510k.jpg K913836 - VLC GLASS IONOMER K913836 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Oct 1991. https://www.510kdatabase.net/k914130/ 1991-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k914130-auto-suture-titanium-skin-and-fascia-fda-510k.jpg K914130 - AUTO SUTURE TITANIUM SKIN AND FASCIA STAPLES K914130 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Oct 1991. https://www.510kdatabase.net/k913689/ 1991-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k913689-sub-4tm-peripheral-dilatation-catheter-fda-510k.jpg K913689 - SUB-4(TM), PERIPHERAL DILATATION CATHETER K913689 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Oct 1991. https://www.510kdatabase.net/k913801/ 1991-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k913801-cordis-cath-sheath-intro-syst-plus-fda-510k.jpg K913801 - CORDIS CATH SHEATH INTRO SYST PLUS W/UNISTASIS VAL K913801 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Oct 1991. https://www.510kdatabase.net/k910421/ 1991-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k910421-saturationhematocrit-monitor-system-fda-510k.jpg K910421 - SATURATION/HEMATOCRIT MONITOR SYSTEM K910421 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Oct 1991. https://www.510kdatabase.net/k911598/ 1991-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k911598-datascope-passport-monitor-fda-510k.jpg K911598 - DATASCOPE PASSPORT MONITOR K911598 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Oct 1991. https://www.510kdatabase.net/k912107/ 1991-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k912107-gore-tex-expanded-poly-card-patch-06-fda-510k.jpg K912107 - GORE-TEX EXPANDED POLY. CARD. PATCH 0.6 AND 0.4MM K912107 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Oct 1991. https://www.510kdatabase.net/k912330/ 1991-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k912330-b-dtm-microfinetm-iv-pen-injector-cat-fda-510k.jpg K912330 - B-D(TM) MICROFINE(TM) IV PEN INJECTOR CAT. #328204 K912330 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1991. https://www.510kdatabase.net/k912369/ 1991-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k912369-hap-bio-groove-total-hip-prosthesis-fda-510k.jpg K912369 - HAP BIO-GROOVE TOTAL HIP PROSTHESIS (BIO-COAT) K912369 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Oct 1991. https://www.510kdatabase.net/k912370/ 1991-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k912370-hap-bio-groove-total-hip-prosth-bio-fda-510k.jpg K912370 - HAP BIO-GROOVE TOTAL HIP PROSTH (BIO-INTERFACES) K912370 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Oct 1991. https://www.510kdatabase.net/k913188/ 1991-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k913188-kinemax-plus-tibial-insert-fda-510k.jpg K913188 - KINEMAX PLUS TIBIAL INSERT K913188 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Oct 1991. https://www.510kdatabase.net/k913307/ 1991-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k913307-abbott-quickstart-total-bilirubin-tbil-fda-510k.jpg K913307 - ABBOTT QUICKSTART TOTAL BILIRUBIN (TBIL) #5A21 K913307 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Oct 1991. https://www.510kdatabase.net/k913506/ 1991-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k913506-convertors-safecare-gown-drape-material-fda-510k.jpg K913506 - CONVERTORS SAFECARE GOWN & DRAPE MATERIAL K913506 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Oct 1991. https://www.510kdatabase.net/k913927/ 1991-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k913927-il-bg3-syst-model-1420-blood-gas-ph-fda-510k.jpg K913927 - IL BG3 SYST, MODEL 1420, BLOOD GAS & PH TEST SYST K913927 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Oct 1991. https://www.510kdatabase.net/k914262/ 1991-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k914262-abbott-quickstart-ldh5a31-fda-510k.jpg K914262 - ABBOTT QUICKSTART LDH,#5A31 K914262 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Oct 1991. https://www.510kdatabase.net/k912711/ 1991-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k912711-il-test-proclot-assay-stystem-fda-510k.jpg K912711 - IL TEST PROCLOT ASSAY STYSTEM K912711 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Oct 1991. https://www.510kdatabase.net/k913025/ 1991-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k913025-abbott-quickstart-albumin-bcp-albp5a16-fda-510k.jpg K913025 - ABBOTT QUICKSTART ALBUMIN BCP (ALBP)#5A16 K913025 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Oct 1991. https://www.510kdatabase.net/k913061/ 1991-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k913061-fibrinogen-determination-kit-fda-510k.jpg K913061 - FIBRINOGEN DETERMINATION KIT K913061 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Oct 1991. https://www.510kdatabase.net/k913698/ 1991-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k913698-accelar-20-advance-rapid-cure-repair-fda-510k.jpg K913698 - ACCELAR 20 ADVANCE RAPID CURE REPAIR MATERIAL K913698 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Oct 1991. https://www.510kdatabase.net/k913699/ 1991-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k913699-modern-materials-orthodontic-resin-fda-510k.jpg K913699 - MODERN MATERIALS ORTHODONTIC RESIN K913699 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Oct 1991. https://www.510kdatabase.net/k913705/ 1991-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k913705-abbott-qluickstart-iron-test-item-5a29-fda-510k.jpg K913705 - ABBOTT QLUICKSTART IRON TEST, ITEM #5A29 K913705 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Oct 1991. https://www.510kdatabase.net/k913789/ 1991-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k913789-aerobic-foam-swab-culturetter-fda-510k.jpg K913789 - AEROBIC FOAM SWAB CULTURETTE(R) K913789 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1991. https://www.510kdatabase.net/k913978/ 1991-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k913978-total-protein-reagent-beckman-synchron-fda-510k.jpg K913978 - TOTAL PROTEIN REAGENT BECKMAN SYNCHRON CX3 ANALYZE K913978 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Oct 1991. https://www.510kdatabase.net/k912698/ 1991-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k912698-affinity-free-t4-test-system-fda-510k.jpg K912698 - AFFINITY FREE T4 TEST SYSTEM K912698 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1991. https://www.510kdatabase.net/k913537/ 1991-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k913537-memosil-cd-fda-510k.jpg K913537 - MEMOSIL C.D. K913537 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Oct 1991. https://www.510kdatabase.net/k914068/ 1991-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k914068-abbott-quickstart-asparate-fda-510k.jpg K914068 - ABBOTT QUICKSTART ASPARATE AMINOTRANSFERASE TEST K914068 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Oct 1991. https://www.510kdatabase.net/k910427/ 1991-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k910427-memfix-screws-fda-510k.jpg K910427 - MEMFIX SCREWS K910427 is a FDA 510(k) cleared dental medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Sep 1991. https://www.510kdatabase.net/k913030/ 1991-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k913030-max-i-probe-irrigation-system-fda-510k.jpg K913030 - MAX-I-PROBE IRRIGATION SYSTEM K913030 is a FDA 510(k) cleared dental medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Sep 1991. https://www.510kdatabase.net/k913469/ 1991-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k913469-endopath-disposable-endoscopic-fda-510k.jpg K913469 - ENDOPATH DISPOSABLE ENDOSCOPIC MULTIFEED STAPLER K913469 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Sep 1991. https://www.510kdatabase.net/k913840/ 1991-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k913840-microtak-plus-fda-510k.jpg K913840 - MICROTAK PLUS K913840 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Sep 1991. https://www.510kdatabase.net/k911630/ 1991-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k911630-laparoscopic-cholangiography-catheter-fda-510k.jpg K911630 - LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER WITH BALLOON K911630 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Sep 1991. https://www.510kdatabase.net/k912454/ 1991-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k912454-kodak-ektascan-xlp-preliminary-dv2000-fda-510k.jpg K912454 - KODAK EKTASCAN XLP PRELIMINARY DV2000 INTERFACE K912454 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Sep 1991. https://www.510kdatabase.net/k912539/ 1991-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k912539-signa-advantage-05t-magnetic-resonance-fda-510k.jpg K912539 - SIGNA ADVANTAGE 0.5T MAGNETIC RESONANCE SYSTEM K912539 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Sep 1991. https://www.510kdatabase.net/k912615/ 1991-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k912615-roche-cobas-argos-5-diff-fda-510k.jpg K912615 - ROCHE COBAS ARGOS 5 DIFF K912615 is a FDA 510(k) cleared hematology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Sep 1991. https://www.510kdatabase.net/k912754/ 1991-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k912754-abuscreen-radioimmunoassay-for-fda-510k.jpg K912754 - ABUSCREEN RADIOIMMUNOASSAY FOR METHAMPHETAMINE K912754 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Sep 1991. https://www.510kdatabase.net/k912852/ 1991-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k912852-stratusr-ultra-sensit-htsh-fluor-fda-510k.jpg K912852 - STRATUS(R) ULTRA-SENSIT HTSH FLUOR ENZYME IMMUNO K912852 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Baxter Healthcare Corp. Cleared Sep 1991. https://www.510kdatabase.net/k912973/ 1991-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k912973-endoscope-suture-carrier-fda-510k.jpg K912973 - ENDOSCOPE SUTURE & CARRIER K912973 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Sep 1991. https://www.510kdatabase.net/k913130/ 1991-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k913130-stratus-iintellect-immunoassay-system-fda-510k.jpg K913130 - STRATUS IINTELLECT IMMUNOASSAY SYSTEM K913130 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Baxter Healthcare Corp. Cleared Sep 1991. https://www.510kdatabase.net/k913162/ 1991-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k913162-enzymun-test-estradiol-fda-510k.jpg K913162 - ENZYMUN-TEST ESTRADIOL K913162 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Sep 1991. https://www.510kdatabase.net/k913706/ 1991-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k913706-abbott-quickstart-uric-acid-test-urca-fda-510k.jpg K913706 - ABBOTT QUICKSTART URIC ACID TEST (URCA) ITEM# 5A34 K913706 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Sep 1991. https://www.510kdatabase.net/k913920/ 1991-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k913920-abbott-quickstart-albumin-test-albg-fda-510k.jpg K913920 - ABBOTT QUICKSTART ALBUMIN TEST (ALBG) ITEM #5A37 K913920 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Sep 1991. https://www.510kdatabase.net/k912616/ 1991-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k912616-technicon-immuno-1-tm-system-fda-510k.jpg K912616 - TECHNICON IMMUNO 1 TM SYSTEM ADDITIONAL ANALYTES K912616 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Sep 1991. https://www.510kdatabase.net/k912839/ 1991-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k912839-laparooptxtm-intraoper-deflect-fda-510k.jpg K912839 - LAPAROOPTX(TM) INTRAOPER DEFLECT CHOLEDOCHOSCOPE K912839 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Sep 1991. https://www.510kdatabase.net/k912932/ 1991-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k912932-synthes-maxillofacial-titanium-micro-set-fda-510k.jpg K912932 - SYNTHES MAXILLOFACIAL TITANIUM MICRO SET K912932 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Sep 1991. https://www.510kdatabase.net/k913196/ 1991-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k913196-kodak-ektachem-dt-slides-lipase-fda-510k.jpg K913196 - KODAK EKTACHEM DT SLIDES (LIPASE) K913196 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Sep 1991. https://www.510kdatabase.net/k913211/ 1991-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k913211-auto-suturer-thin-tissue-giatm-surg-fda-510k.jpg K913211 - AUTO SUTURE(R) THIN TISSUE GIA(TM) SURG STAPLER K913211 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Sep 1991. https://www.510kdatabase.net/k913414/ 1991-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k913414-abuscreenr-onlinetm-for-fda-510k.jpg K913414 - ABUSCREEN(R) ONLINE(TM) FOR THC(50/100)(100TEST KT K913414 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Sep 1991. https://www.510kdatabase.net/k913902/ 1991-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k913902-b-dr-hypoallergeniic-non-sterile-pat-fda-510k.jpg K913902 - B-D(R) HYPOALLERGENIIC NON-STERILE PAT EXAM GLOVES K913902 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1991. https://www.510kdatabase.net/k905709/ 1991-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k905709-beckman-diatrac-hemoglobin-a-fda-510k.jpg K905709 - BECKMAN DIATRAC HEMOGLOBIN A ELECTROPHORESIS KIT K905709 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Sep 1991. https://www.510kdatabase.net/k912972/ 1991-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k912972-flexiflo-over-the-guidewire-jejunal-fda-510k.jpg K912972 - FLEXIFLO OVER THE GUIDEWIRE JEJUNAL FEEDING TUBE K912972 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1991. https://www.510kdatabase.net/k913002/ 1991-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k913002-bactidroptm-ferric-chloride-10-fda-510k.jpg K913002 - BACTIDROP(TM) FERRIC CHLORIDE (10%) K913002 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Sep 1991. https://www.510kdatabase.net/k913003/ 1991-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k913003-bactidroptm-voges-proskauer-a-fda-510k.jpg K913003 - BACTIDROP(TM) VOGES-PROSKAUER A K913003 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Sep 1991. https://www.510kdatabase.net/k913006/ 1991-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k913006-bactidroptm-dobell-oconnor-iodine-fda-510k.jpg K913006 - BACTIDROP(TM) DOBELL & O'CONNOR IODINE K913006 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Sep 1991. https://www.510kdatabase.net/k913007/ 1991-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k913007-bactidroptm-voges-proskauer-b-fda-510k.jpg K913007 - BACTIDROP(TM) VOGES-PROSKAUER B K913007 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Sep 1991. https://www.510kdatabase.net/k913008/ 1991-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k913008-bactidroptm-oxidase-fda-510k.jpg K913008 - BACTIDROP(TM) OXIDASE K913008 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Sep 1991. https://www.510kdatabase.net/k913627/ 1991-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k913627-3-port-adapter-fda-510k.jpg K913627 - 3 PORT ADAPTER K913627 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Sep 1991. https://www.510kdatabase.net/k913828/ 1991-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k913828-qtest-influenza-a-fda-510k.jpg K913828 - QTEST INFLUENZA A K913828 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1991. https://www.510kdatabase.net/k912777/ 1991-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k912777-cordis-7-french-0072-id-ptca-guiding-fda-510k.jpg K912777 - CORDIS 7 FRENCH 0.072 I.D. PTCA GUIDING CATHETER K912777 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Sep 1991. https://www.510kdatabase.net/k912005/ 1991-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k912005-codman-skull-pins-adult-child-reusable-fda-510k.jpg K912005 - CODMAN SKULL PINS (ADULT & CHILD), REUSABLE K912005 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Sep 1991. https://www.510kdatabase.net/k912087/ 1991-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k912087-acl-coagulation-systemsmodels-fda-510k.jpg K912087 - ACL COAGULATION SYSTEMS,MODELS 1000,2000,3000,PLUS K912087 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 1991. https://www.510kdatabase.net/k912097/ 1991-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k912097-auto-suture-endoscopic-fascia-stapler-fda-510k.jpg K912097 - AUTO SUTURE ENDOSCOPIC FASCIA STAPLER K912097 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Sep 1991. https://www.510kdatabase.net/k913010/ 1991-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k913010-bactidrop-tm-nitrate-b-fda-510k.jpg K913010 - BACTIDROP (TM) NITRATE B K913010 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Sep 1991. https://www.510kdatabase.net/k913011/ 1991-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k913011-bactidroptm-nitrate-a-fda-510k.jpg K913011 - BACTIDROP(TM) NITRATE A K913011 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Sep 1991. https://www.510kdatabase.net/k913123/ 1991-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k913123-emitr-2000-theophylline-assaycalibrators-fda-510k.jpg K913123 - EMIT(R) 2000 THEOPHYLLINE ASSAY/CALIBRATORS K913123 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Sep 1991. https://www.510kdatabase.net/k913534/ 1991-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k913534-vista-hpq-system-fda-510k.jpg K913534 - VISTA HPQ SYSTEM K913534 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Sep 1991. https://www.510kdatabase.net/k913846/ 1991-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k913846-abbott-quickstart-alanine-aminotransfer-fda-510k.jpg K913846 - ABBOTT QUICKSTART ALANINE AMINOTRANSFER K913846 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Sep 1991. https://www.510kdatabase.net/k913922/ 1991-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k913922-abbott-quickstart-tibc-pretreatment-fda-510k.jpg K913922 - ABBOTT QUICKSTART TIBC PRETREATMENT KIT, 5A29-01 K913922 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Sep 1991. https://www.510kdatabase.net/k912235/ 1991-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k912235-models-432-03-433-03-implant-endocard-fda-510k.jpg K912235 - MODELS 432-03 & 433-03 IMPLANT ENDOCARD PAC LEAD K912235 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Sep 1991. https://www.510kdatabase.net/k913001/ 1991-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k913001-bactidroptm-desoxycholate-10-fda-510k.jpg K913001 - BACTIDROP(TM) DESOXYCHOLATE (10%) K913001 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Sep 1991. https://www.510kdatabase.net/k913004/ 1991-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k913004-bactidroptm-spot-indole-fda-510k.jpg K913004 - BACTIDROP(TM) SPOT INDOLE K913004 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Sep 1991. https://www.510kdatabase.net/k913009/ 1991-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k913009-bactidroptm-indole-kovacs-fda-510k.jpg K913009 - BACTIDROP(TM) INDOLE (KOVACS) K913009 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Sep 1991. https://www.510kdatabase.net/k913707/ 1991-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k913707-abbott-quickstart-creatinine-testcrea-fda-510k.jpg K913707 - ABBOTT QUICKSTART CREATININE TEST(CREA) ITEM# 5A28 K913707 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Sep 1991. https://www.510kdatabase.net/k911433/ 1991-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k911433-right-angle-catheter-for-ventricular-fda-510k.jpg K911433 - RIGHT-ANGLE CATHETER FOR VENTRICULAR DRAINAGE K911433 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cordis Corp.. Cleared Sep 1991. https://www.510kdatabase.net/k912644/ 1991-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k912644-cordis-inflator-device-fda-510k.jpg K912644 - CORDIS INFLATOR DEVICE K912644 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Sep 1991. https://www.510kdatabase.net/k912945/ 1991-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k912945-satin-prophylaxis-paste-fda-510k.jpg K912945 - SATIN PROPHYLAXIS PASTE K912945 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Sep 1991. https://www.510kdatabase.net/k913005/ 1991-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k913005-bactidroptm-lactophenol-aniline-blue-fda-510k.jpg K913005 - BACTIDROP(TM) LACTOPHENOL ANILINE BLUE K913005 is a FDA 510(k) cleared hematology medical device. Manufacturer: Remel Co.. Cleared Sep 1991. https://www.510kdatabase.net/k913410/ 1991-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k913410-emitr-2000-gentamicin-assaycalibrators-fda-510k.jpg K913410 - EMIT(R) 2000 GENTAMICIN ASSAY/CALIBRATORS K913410 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Sep 1991. https://www.510kdatabase.net/k912655/ 1991-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k912655-minimax-oxygenation-system-fda-510k.jpg K912655 - MINIMAX OXYGENATION SYSTEM K912655 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Sep 1991. https://www.510kdatabase.net/k913615/ 1991-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k913615-urinarycsf-protein-fda-510k.jpg K913615 - URINARY/CSF PROTEIN K913615 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Sep 1991. https://www.510kdatabase.net/k912141/ 1991-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k912141-volumetric-pump-solution-set-modified-fda-510k.jpg K912141 - VOLUMETRIC PUMP SOLUTION SET MODIFIED CASSETTE K912141 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Sep 1991. https://www.510kdatabase.net/k912368/ 1991-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k912368-imx-select-analyzer-fda-510k.jpg K912368 - IMX SELECT ANALYZER K912368 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1991. https://www.510kdatabase.net/k912722/ 1991-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k912722-hyper-k-heat-system-fda-510k.jpg K912722 - HYPER-K HEAT SYSTEM K912722 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Baxter Healthcare Corp. Cleared Sep 1991. https://www.510kdatabase.net/k912806/ 1991-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k912806-abbott-quickstart-bicarbonate-test-co2-fda-510k.jpg K912806 - ABBOTT QUICKSTART BICARBONATE TEST CO2 ITEM# 5A22 K912806 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Sep 1991. https://www.510kdatabase.net/k913207/ 1991-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k913207-triflexr-powder-free-sterile-surgeons-fda-510k.jpg K913207 - TRIFLEX(R) POWDER FREE STERILE SURGEON'S GLOVE K913207 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Sep 1991. https://www.510kdatabase.net/k913563/ 1991-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k913563-magnetic-resonance-diagnostic-device-fda-510k.jpg K913563 - MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIY K913563 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 1991. https://www.510kdatabase.net/k913858/ 1991-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k913858-amylase-reagent-procedure-577-fda-510k.jpg K913858 - AMYLASE REAGENT (PROCEDURE 577) K913858 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Sep 1991. https://www.510kdatabase.net/k905860/ 1991-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k905860-heyer-schulte-spinal-cyst-fda-510k.jpg K905860 - HEYER-SCHULTE SPINAL CYST CATHETER/MODIFICATION K905860 is a FDA 510(k) cleared neurology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Sep 1991. https://www.510kdatabase.net/k910940/ 1991-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k910940-anatomic-modular-knee-polyethylene-fda-510k.jpg K910940 - ANATOMIC MODULAR KNEE POLYETHYLENE TIBIAL TRAY K910940 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Sep 1991. https://www.510kdatabase.net/k911723/ 1991-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k911723-codman-disposable-skull-pins-fda-510k.jpg K911723 - CODMAN DISPOSABLE SKULL PINS K911723 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Sep 1991. https://www.510kdatabase.net/k911959/ 1991-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k911959-signa-advantage-magnetic-resonance-fda-510k.jpg K911959 - SIGNA ADVANTAGE MAGNETIC RESONANCE SYSTEM M1090GF K911959 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Sep 1991. https://www.510kdatabase.net/k912549/ 1991-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k912549-bardr-disposable-biopsy-forceps-fda-510k.jpg K912549 - BARD(R) DISPOSABLE BIOPSY FORCEPS K912549 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Sep 1991. https://www.510kdatabase.net/k912679/ 1991-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k912679-dader-immunoadsorbed-fact-v-def-plasma-fda-510k.jpg K912679 - DADE(R) IMMUNOADSORBED FACT V DEF PLASMA (HUMAN) K912679 is a FDA 510(k) cleared hematology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Sep 1991. https://www.510kdatabase.net/k913722/ 1991-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k913722-abuscreenr-radioimmun-for-cocaine-fda-510k.jpg K913722 - ABUSCREEN(R) RADIOIMMUN FOR COCAINE METABOLITE K913722 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Sep 1991. https://www.510kdatabase.net/k913739/ 1991-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k913739-il-testtm-dat-calibrator-a--fda-510k.jpg K913739 - IL TEST(TM) DAT CALIBRATOR A( -) K913739 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 1991. https://www.510kdatabase.net/k910902/ 1991-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k910902-vmx-mobile-x-ray-system-fda-510k.jpg K910902 - VMX MOBILE X-RAY SYSTEM K910902 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Sep 1991. https://www.510kdatabase.net/k912554/ 1991-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k912554-annuloplasty-rings-model-4400-mirtal-fda-510k.jpg K912554 - ANNULOPLASTY RINGS, MODEL 4400 MIRTAL AND 4500 TRI K912554 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Sep 1991. https://www.510kdatabase.net/k912881/ 1991-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k912881-ge-mr-max-fda-510k.jpg K912881 - GE MR MAX K912881 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Sep 1991. https://www.510kdatabase.net/k913139/ 1991-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k913139-implantable-metal-staples-fda-510k.jpg K913139 - IMPLANTABLE METAL STAPLES K913139 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Sep 1991. https://www.510kdatabase.net/k913170/ 1991-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k913170-codman-skull-clamp-fda-510k.jpg K913170 - CODMAN SKULL CLAMP K913170 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Sep 1991. https://www.510kdatabase.net/k913232/ 1991-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k913232-ultracrowntm-pd-dental-alloy-fda-510k.jpg K913232 - ULTRACROWN(TM) PD DENTAL ALLOY K913232 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Sep 1991. https://www.510kdatabase.net/k911625/ 1991-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k911625-ames-dca-2000tm-analyzer-and-reagent-fda-510k.jpg K911625 - AMES DCA 2000TM ANALYZER AND REAGENT SYSTEM K911625 is a FDA 510(k) cleared hematology medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Sep 1991. https://www.510kdatabase.net/k912844/ 1991-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k912844-kodak-ektachem-dtii-system-fda-510k.jpg K912844 - KODAK EKTACHEM DTII SYSTEM K912844 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Sep 1991. https://www.510kdatabase.net/k913354/ 1991-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k913354-kodak-ektascan-storage-phosphor-reader-fda-510k.jpg K913354 - KODAK EKTASCAN STORAGE PHOSPHOR READER MODEL 1A K913354 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Sep 1991. https://www.510kdatabase.net/k904435/ 1991-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k904435-ventrofil-tension-relief-suture-set-fda-510k.jpg K904435 - VENTROFIL TENSION RELIEF SUTURE SET K904435 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Aug 1991. https://www.510kdatabase.net/k910822/ 1991-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k910822-bard-peripheral-balloon-dilatation-fda-510k.jpg K910822 - BARD PERIPHERAL BALLOON DILATATION CATHETER K910822 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Aug 1991. https://www.510kdatabase.net/k912263/ 1991-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k912263-ha-anatomic-hip-prosth-w-ti-nidium-fda-510k.jpg K912263 - HA ANATOMIC HIP PROSTH W/ TI-NIDIUM SURF HARD PROC K912263 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Aug 1991. https://www.510kdatabase.net/k897068/ 1991-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k897068-medtronic-minimax-hollow-fiber-fda-510k.jpg K897068 - MEDTRONIC MINIMAX HOLLOW FIBER OXYGENATOR K897068 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Aug 1991. https://www.510kdatabase.net/k911829/ 1991-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k911829-endostaple-fda-510k.jpg K911829 - ENDOSTAPLE K911829 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Aug 1991. https://www.510kdatabase.net/k912212/ 1991-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k912212-proact-cholesterol-systems-fda-510k.jpg K912212 - PROACT CHOLESTEROL SYSTEMS K912212 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Aug 1991. https://www.510kdatabase.net/k910921/ 1991-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k910921-auto-suture-surgiport-tissue-grip-fda-510k.jpg K910921 - AUTO SUTURE SURGIPORT TISSUE GRIP DISPOSABLE SLEEV K910921 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Aug 1991. https://www.510kdatabase.net/k911772/ 1991-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k911772-gardner-pins-adult-child-fda-510k.jpg K911772 - GARDNER PINS (ADULT & CHILD) K911772 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Aug 1991. https://www.510kdatabase.net/k912755/ 1991-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k912755-abuscreen-radioimmunoassay-for-fda-510k.jpg K912755 - ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE K912755 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Aug 1991. https://www.510kdatabase.net/k912928/ 1991-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k912928-lifecare-4100-pca-infuser-plus-ii-fda-510k.jpg K912928 - LIFECARE 4100 PCA INFUSER PLUS II K912928 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1991. https://www.510kdatabase.net/k913190/ 1991-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k913190-emitr-2000-phenobarbital-fda-510k.jpg K913190 - EMIT(R) 2000 PHENOBARBITAL ASSAY/CALIBRATORS K913190 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Aug 1991. https://www.510kdatabase.net/k913195/ 1991-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k913195-kodak-ektachem-dt-slides-alb-fda-510k.jpg K913195 - KODAK EKTACHEM DT SLIDES (ALB) K913195 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Aug 1991. https://www.510kdatabase.net/k913197/ 1991-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k913197-kodak-ektachem-dt-slides-lac-fda-510k.jpg K913197 - KODAK EKTACHEM DT SLIDES (LAC) K913197 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Aug 1991. https://www.510kdatabase.net/k913198/ 1991-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k913198-kodak-ektachem-dt-slides-che-fda-510k.jpg K913198 - KODAK EKTACHEM DT SLIDES (CHE) K913198 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Aug 1991. https://www.510kdatabase.net/k913335/ 1991-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k913335-abuscreenr-onlinetm-calibrators-fda-510k.jpg K913335 - ABUSCREEN(R) ONLINE(TM) CALIBRATORS K913335 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Aug 1991. https://www.510kdatabase.net/k913336/ 1991-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k913336-abuscreenr-onlinetm-controls-fda-510k.jpg K913336 - ABUSCREEN(R) ONLINE(TM) CONTROLS K913336 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Aug 1991. https://www.510kdatabase.net/k913429/ 1991-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k913429-emitr-2000-phenytoin-assaycalibrators-fda-510k.jpg K913429 - EMIT(R) 2000 PHENYTOIN ASSAY/CALIBRATORS K913429 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Aug 1991. https://www.510kdatabase.net/k912480/ 1991-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k912480-bblr-dmaca-indole-reagent-droppers-fda-510k.jpg K912480 - BBL(R) DMACA INDOLE REAGENT DROPPERS K912480 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1991. https://www.510kdatabase.net/k913594/ 1991-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k913594-dynex-iiib-model-89002026-fda-510k.jpg K913594 - DYNEX IIIB, MODEL 89002026 K913594 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Aug 1991. https://www.510kdatabase.net/k911051/ 1991-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k911051-monarch-system-fda-510k.jpg K911051 - MONARCH SYSTEM K911051 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Aug 1991. https://www.510kdatabase.net/k911777/ 1991-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k911777-rocket-reference-plasma-cat-no-5188-fda-510k.jpg K911777 - ROCKET REFERENCE PLASMA, CAT. NO. 5188, MODIFIED K911777 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Aug 1991. https://www.510kdatabase.net/k912774/ 1991-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k912774-arachidonic-acid-fda-510k.jpg K912774 - ARACHIDONIC ACID K912774 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Aug 1991. https://www.510kdatabase.net/k912832/ 1991-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k912832-bacti-swabtm-npg-fda-510k.jpg K912832 - BACTI-SWAB(TM) NPG K912832 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Aug 1991. https://www.510kdatabase.net/k912426/ 1991-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k912426-uhmwp-acetabular-component-fda-510k.jpg K912426 - UHMWP ACETABULAR COMPONENT K912426 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Aug 1991. https://www.510kdatabase.net/k900205/ 1991-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k900205-drainage-catheters-wa-dissolvable-tip-fda-510k.jpg K900205 - DRAINAGE CATHETERS W/A DISSOLVABLE TIP K900205 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Aug 1991. https://www.510kdatabase.net/k911789/ 1991-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k911789-minimax-tm-hardshell-venous-res-winte-fda-510k.jpg K911789 - MINIMAX (TM) HARDSHELL VENOUS RES W/INTE CARD FILT K911789 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Aug 1991. https://www.510kdatabase.net/k912245/ 1991-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k912245-agc-revision-knee-prothesis-fda-510k.jpg K912245 - AGC REVISION KNEE PROTHESIS K912245 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Aug 1991. https://www.510kdatabase.net/k910190/ 1991-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k910190-bard-monopty-disposable-core-biopsy-fda-510k.jpg K910190 - BARD MONOPTY DISPOSABLE CORE BIOPSY INSTRUMENT K910190 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Aug 1991. https://www.510kdatabase.net/k910846/ 1991-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k910846-bard-latex-urinary-catheters-drains-fda-510k.jpg K910846 - BARD LATEX URINARY CATHETERS DRAINS- DESIGNS MODIF K910846 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Aug 1991. https://www.510kdatabase.net/k910938/ 1991-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k910938-codman-external-drainage-system-ii-eds-fda-510k.jpg K910938 - CODMAN EXTERNAL DRAINAGE SYSTEM II (EDS II) K910938 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Aug 1991. https://www.510kdatabase.net/k911728/ 1991-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k911728-omnifitr-epf-dual-geomtryradiusthread-fda-510k.jpg K911728 - OMNIFIT(R) EPF DUAL GEOMTRY/RADIUS/THREAD ACETAB C K911728 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Aug 1991. https://www.510kdatabase.net/k912201/ 1991-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k912201-packs-4-tm-analyzer-fda-510k.jpg K912201 - PACKS-4 (TM) ANALYZER K912201 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Aug 1991. https://www.510kdatabase.net/k912365/ 1991-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k912365-tdxrtdxflxtm-adxr-propoxphene-assays-fda-510k.jpg K912365 - TDX(R)/TDXFLX(TM) & ADX(R) PROPOXPHENE ASSAYS K912365 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1991. https://www.510kdatabase.net/k912415/ 1991-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k912415-medical-safety-cable-and-lead-system-fda-510k.jpg K912415 - MEDICAL SAFETY CABLE AND LEAD SYSTEM K912415 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Medtronic Vascular. Cleared Aug 1991. https://www.510kdatabase.net/k912654/ 1991-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k912654-omnifit-epf-dual-geometry-acetabular-cup-fda-510k.jpg K912654 - OMNIFIT EPF DUAL GEOMETRY ACETABULAR CUP K912654 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Aug 1991. https://www.510kdatabase.net/k913120/ 1991-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k913120-polystar-angiographic-x-ray-system-fda-510k.jpg K913120 - POLYSTAR ANGIOGRAPHIC X-RAY SYSTEM K913120 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 1991. https://www.510kdatabase.net/k913236/ 1991-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k913236-stratusr-hcg-fluorometric-enzyme-fda-510k.jpg K913236 - STRATUS(R) HCG FLUOROMETRIC ENZYME IMMUNOASSAY K913236 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Aug 1991. https://www.510kdatabase.net/k910453/ 1991-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k910453-tops-needle-tip-probe-pvc-tip-probe-fda-510k.jpg K910453 - TOPS NEEDLE TIP PROBE & PVC TIP PROBE K910453 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Aug 1991. https://www.510kdatabase.net/k912147/ 1991-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k912147-osteonics-7000-series-stand-total-knee-fda-510k.jpg K912147 - OSTEONICS 7000 SERIES STAND TOTAL KNEE FEMOR COMP K912147 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Aug 1991. https://www.510kdatabase.net/k911790/ 1991-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k911790-minimax-tm-collapsible-venous-fda-510k.jpg K911790 - MINIMAX (TM) COLLAPSIBLE VENOUS RESERVOIR BAG K911790 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Aug 1991. https://www.510kdatabase.net/k912455/ 1991-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k912455-dade-iac-x-comprehensive-immunoassay-fda-510k.jpg K912455 - DADE IAC-X COMPREHENSIVE IMMUNOASSAY CONTROL K912455 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Baxter Healthcare Corp. Cleared Aug 1991. https://www.510kdatabase.net/k912541/ 1991-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k912541-milenia-total-t4-catalog-mkt415-fda-510k.jpg K912541 - MILENIA TOTAL T4, CATALOG: MKT41,5 K912541 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Aug 1991. https://www.510kdatabase.net/k912574/ 1991-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k912574-abuscreen-online-for-thc-50-and-100-fda-510k.jpg K912574 - ABUSCREEN ONLINE FOR THC (50 AND 100) K912574 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Aug 1991. https://www.510kdatabase.net/k912809/ 1991-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k912809-abbott-quickstart-phosphorusphos-item-fda-510k.jpg K912809 - ABBOTT QUICKSTART PHOSPHORUS(PHOS) ITEM #5A14 K912809 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Aug 1991. https://www.510kdatabase.net/k913105/ 1991-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k913105-reflotron-creatinine-test-tabs-fda-510k.jpg K913105 - REFLOTRON CREATININE TEST TABS K913105 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Aug 1991. https://www.510kdatabase.net/k913107/ 1991-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k913107-abuscreenr-ontrakr-positive-ref-cont-fda-510k.jpg K913107 - ABUSCREEN(R) ONTRAK(R) POSITIVE REF CONT BENZODIAZ K913107 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Aug 1991. https://www.510kdatabase.net/k913124/ 1991-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k913124-roche-reagent-for-ammonia-fda-510k.jpg K913124 - ROCHE REAGENT FOR AMMONIA K913124 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Aug 1991. https://www.510kdatabase.net/k913125/ 1991-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k913125-roche-reagent-for-ethanol-fda-510k.jpg K913125 - ROCHE REAGENT FOR ETHANOL K913125 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Aug 1991. https://www.510kdatabase.net/k903434/ 1991-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k903434-select-neuromuscular-stimulators-fda-510k.jpg K903434 - SELECT NEUROMUSCULAR STIMULATORS K903434 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Aug 1991. https://www.510kdatabase.net/k910195/ 1991-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k910195-bard-hydrogel-coated-foley-catheters-fda-510k.jpg K910195 - BARD HYDROGEL-COATED FOLEY CATHETERS K910195 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Aug 1991. https://www.510kdatabase.net/k910197/ 1991-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k910197-hydrogel-coated-urethral-catheters-and-fda-510k.jpg K910197 - HYDROGEL-COATED URETHRAL CATHETERS AND DRAINS K910197 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Aug 1991. https://www.510kdatabase.net/k911856/ 1991-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k911856-respironics-remstar-with-remote-and-ramp-fda-510k.jpg K911856 - RESPIRONICS REMSTAR WITH REMOTE AND RAMP K911856 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Aug 1991. https://www.510kdatabase.net/k911876/ 1991-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k911876-shiley-plexusr-venous-reservoir-pvr1200-fda-510k.jpg K911876 - SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200 K911876 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Aug 1991. https://www.510kdatabase.net/k912095/ 1991-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k912095-magnetic-resonance-diagnostic-device-fda-510k.jpg K912095 - MAGNETIC RESONANCE DIAGNOSTIC DEVICE K912095 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 1991. https://www.510kdatabase.net/k910382/ 1991-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k910382-flexiflo-enteral-feeding-tube-fda-510k.jpg K910382 - FLEXIFLO ENTERAL FEEDING TUBE K910382 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1991. https://www.510kdatabase.net/k910558/ 1991-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k910558-terumor-arterial-and-venous-blood-line-fda-510k.jpg K910558 - TERUMO(R) ARTERIAL AND VENOUS BLOOD LINE SET K910558 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Terumo Medical Corp.. Cleared Aug 1991. https://www.510kdatabase.net/k911105/ 1991-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k911105-suctionirrigation-device-with-hydro-fda-510k.jpg K911105 - SUCTION/IRRIGATION DEVICE WITH HYDRO-DISSECTION K911105 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Aug 1991. https://www.510kdatabase.net/k912120/ 1991-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k912120-urf-p2-ureterorenofiberscopecholedochofi-fda-510k.jpg K912120 - URF-P2 URETERORENOFIBERSCOPE/CHOLEDOCHOFIBERSCOPE K912120 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Corp.. Cleared Aug 1991. https://www.510kdatabase.net/k912227/ 1991-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k912227-monark-ergometers-fda-510k.jpg K912227 - MONARK ERGOMETERS K912227 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Quinton, Inc.. Cleared Aug 1991. https://www.510kdatabase.net/k911964/ 1991-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k911964-modified-pancretec-provider-one-fda-510k.jpg K911964 - MODIFIED PANCRETEC PROVIDER ONE INFUSION SYSTEM K911964 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1991. https://www.510kdatabase.net/k912092/ 1991-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k912092-modified-lifecare-model-175-infuser-fda-510k.jpg K912092 - MODIFIED LIFECARE MODEL 175 INFUSER K912092 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1991. https://www.510kdatabase.net/k912011/ 1991-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k912011-codman-skull-clamp-fda-510k.jpg K912011 - CODMAN SKULL CLAMP K912011 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Jul 1991. https://www.510kdatabase.net/k913233/ 1991-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k913233-codman-lhalo-split-ring-retractor-system-fda-510k.jpg K913233 - CODMAN LHALO SPLIT RING RETRACTOR SYSTEM K913233 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Jul 1991. https://www.510kdatabase.net/k910482/ 1991-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k910482-alta-channel-plate-connector-fda-510k.jpg K910482 - ALTA CHANNEL PLATE CONNECTOR K910482 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jul 1991. https://www.510kdatabase.net/k911302/ 1991-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k911302-models-5866-24m5866-38m5866-40m6986m-fda-510k.jpg K911302 - MODELS 5866-24M/5866-38M/5866-40M/6986M ADAPT KIT K911302 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jul 1991. https://www.510kdatabase.net/k912084/ 1991-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k912084-medtronic-cardiocare-memorytrace-er-fda-510k.jpg K912084 - MEDTRONIC CARDIOCARE MEMORYTRACE ER MODEL 4221 K912084 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jul 1991. https://www.510kdatabase.net/k912603/ 1991-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k912603-rep-alp-15-8-4-kits-fda-510k.jpg K912603 - REP ALP-15, 8, & 4 KITS K912603 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Jul 1991. https://www.510kdatabase.net/k912808/ 1991-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k912808-abbott-quick-start-glucose-glue-item-fda-510k.jpg K912808 - ABBOTT QUICK START GLUCOSE (GLUE) ITEM# 5A15 K912808 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jul 1991. https://www.510kdatabase.net/k912810/ 1991-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k912810-abbott-quickstart-total-protein-test-fda-510k.jpg K912810 - ABBOTT QUICKSTART TOTAL PROTEIN TEST ITEM# 5A13 K912810 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jul 1991. https://www.510kdatabase.net/k912831/ 1991-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k912831-bacti-swabtm-ii-fda-510k.jpg K912831 - BACTI-SWAB(TM) II K912831 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Jul 1991. https://www.510kdatabase.net/k912917/ 1991-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k912917-milenia-estradiol-fda-510k.jpg K912917 - MILENIA ESTRADIOL K912917 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jul 1991. https://www.510kdatabase.net/k913066/ 1991-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k913066-emitr-2000-carbamazepine-fda-510k.jpg K913066 - EMIT(R) 2000 CARBAMAZEPINE ASSAY/CALIBRATORS K913066 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jul 1991. https://www.510kdatabase.net/k910877/ 1991-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k910877-finn-knee-prosthesis-fda-510k.jpg K910877 - FINN KNEE PROSTHESIS K910877 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jul 1991. https://www.510kdatabase.net/k911890/ 1991-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k911890-osteonicsr-prt-hip-stem-series-fda-510k.jpg K911890 - OSTEONICS(R) PRT HIP STEM SERIES K911890 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Jul 1991. https://www.510kdatabase.net/k911904/ 1991-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k911904-models-ues-10-psd-10-fda-510k.jpg K911904 - MODELS UES-10 & PSD-10 K911904 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Olympus Corp.. Cleared Jul 1991. https://www.510kdatabase.net/k912048/ 1991-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k912048-abuscreenr-onlinetm-thc-calibrators-fda-510k.jpg K912048 - ABUSCREEN(R) ONLINE(TM) THC CALIBRATORS K912048 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jul 1991. https://www.510kdatabase.net/k912756/ 1991-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k912756-abuscreen-radioimmunoassay-for-cocaine-fda-510k.jpg K912756 - ABUSCREEN RADIOIMMUNOASSAY FOR COCAINE METABOLITE K912756 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jul 1991. https://www.510kdatabase.net/k912757/ 1991-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k912757-abuscreen-radioimmunoassay-for-fda-510k.jpg K912757 - ABUSCREEN RADIOIMMUNOASSAY FOR CANNABINIODS K912757 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jul 1991. https://www.510kdatabase.net/k912758/ 1991-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k912758-abuscreen-online-for-amphetamines-fda-510k.jpg K912758 - ABUSCREEN ONLINE FOR AMPHETAMINES K912758 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jul 1991. https://www.510kdatabase.net/k912959/ 1991-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k912959-microtrak-manager-fda-510k.jpg K912959 - MICROTRAK MANAGER K912959 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Jul 1991. https://www.510kdatabase.net/k913024/ 1991-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k913024-abbott-quickstart-gamma-fda-510k.jpg K913024 - ABBOTT QUICKSTART GAMMA-GLUTAMYTRANSFERASE TEST K913024 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jul 1991. https://www.510kdatabase.net/k904883/ 1991-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k904883-optyx-fda-510k.jpg K904883 - OPTYX K904883 is a FDA 510(k) cleared neurology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jul 1991. https://www.510kdatabase.net/k910229/ 1991-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k910229-soft-tissue-suture-washer3-hole-washer-fda-510k.jpg K910229 - SOFT TISSUE SUTURE WASHER/3 HOLE WASHER K910229 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jul 1991. https://www.510kdatabase.net/k910492/ 1991-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k910492-bard-replacement-gastrostomy-tube-fda-510k.jpg K910492 - BARD REPLACEMENT GASTROSTOMY TUBE K910492 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jul 1991. https://www.510kdatabase.net/k911640/ 1991-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k911640-olympus-pk-tptm-system-modification-fda-510k.jpg K911640 - OLYMPUS PK TP(TM) SYSTEM, MODIFICATION K911640 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Olympus Corp.. Cleared Jul 1991. https://www.510kdatabase.net/k912061/ 1991-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k912061-heparin-adsorbent-fda-510k.jpg K912061 - HEPARIN ADSORBENT K912061 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Jul 1991. https://www.510kdatabase.net/k912395/ 1991-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k912395-howmedica-precis-osteolock-fem-comp-fda-510k.jpg K912395 - HOWMEDICA PRECIS OSTEOLOCK FEM COMP W/HYDRO COAT K912395 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jul 1991. https://www.510kdatabase.net/k912940/ 1991-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k912940-coat-a-count-beta-2-microglobulin-irma-fda-510k.jpg K912940 - COAT-A-COUNT BETA-2 MICROGLOBULIN IRMA K912940 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jul 1991. https://www.510kdatabase.net/k911853/ 1991-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k911853-pulsatile-anti-embolism-syspump-fda-510k.jpg K911853 - PULSATILE ANTI-EMBOLISM SYS.PUMP K911853 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jul 1991. https://www.510kdatabase.net/k912729/ 1991-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k912729-emit-calibrator-b-level-1cutoff-level-fda-510k.jpg K912729 - EMIT CALIBRATOR B LEVEL 1(CUTOFF) & LEVEL 2(HIGH) K912729 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jul 1991. https://www.510kdatabase.net/k911794/ 1991-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k911794-cath-sheath-introducer-syst-plus-fda-510k.jpg K911794 - CATH SHEATH INTRODUCER SYST PLUS W/UNISTASIS VALVE K911794 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Jul 1991. https://www.510kdatabase.net/k911838/ 1991-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k911838-roche-reagent-for-c02-fda-510k.jpg K911838 - ROCHE REAGENT FOR C02 K911838 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jul 1991. https://www.510kdatabase.net/k911991/ 1991-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k911991-magnetom-p8-magnetic-resonance-fda-510k.jpg K911991 - MAGNETOM P8 MAGNETIC RESONANCE DIAGNOSTIC DEVICE K911991 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 1991. https://www.510kdatabase.net/k912380/ 1991-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k912380-laser-beam-localizer-for-siremobil-4-fda-510k.jpg K912380 - LASER BEAM LOCALIZER FOR SIREMOBIL 4 K912380 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 1991. https://www.510kdatabase.net/k912797/ 1991-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k912797-perry-natural-powder-free-gloves-fda-510k.jpg K912797 - PERRY NATURAL POWDER FREE GLOVES K912797 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 1991. https://www.510kdatabase.net/k910808/ 1991-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k910808-q-smart-holter-systems-fda-510k.jpg K910808 - Q-SMART HOLTER SYSTEMS K910808 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Jul 1991. https://www.510kdatabase.net/k911278/ 1991-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k911278-olympus-af-angioscope-system-fda-510k.jpg K911278 - OLYMPUS AF ANGIOSCOPE SYSTEM K911278 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Olympus Corp.. Cleared Jul 1991. https://www.510kdatabase.net/k911917/ 1991-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k911917-codman-pediatric-horseshoe-headrest-fda-510k.jpg K911917 - CODMAN PEDIATRIC HORSESHOE HEADREST K911917 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Jul 1991. https://www.510kdatabase.net/k911918/ 1991-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k911918-swivel-horseshoe-headrest-fda-510k.jpg K911918 - SWIVEL HORSESHOE HEADREST K911918 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Jul 1991. https://www.510kdatabase.net/k912150/ 1991-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k912150-beckman-anti-streptolysin-o-aso-kit-fda-510k.jpg K912150 - BECKMAN ANTI-STREPTOLYSIN O (ASO) KIT K912150 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jul 1991. https://www.510kdatabase.net/k912386/ 1991-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k912386-rep-spe-plus-ponceau-s-system-3163-fda-510k.jpg K912386 - REP SPE PLUS (PONCEAU S) SYSTEM, 3163, 3164 & 3165 K912386 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Jul 1991. https://www.510kdatabase.net/k912441/ 1991-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k912441-linearity-test-kits-fda-510k.jpg K912441 - LINEARITY TEST KITS K912441 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jul 1991. https://www.510kdatabase.net/k912647/ 1991-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k912647-iseci--fda-510k.jpg K912647 - ISE/CI- K912647 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jul 1991. https://www.510kdatabase.net/k912648/ 1991-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k912648-isena-fda-510k.jpg K912648 - ISE/NA+ K912648 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jul 1991. https://www.510kdatabase.net/k911718/ 1991-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k911718-mara-modular-acetabular-reconstruction-fda-510k.jpg K911718 - M.A.R.A. (MODULAR ACETABULAR RECONSTRUCTION SYST) K911718 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jul 1991. https://www.510kdatabase.net/k905713/ 1991-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k905713-bard-ambulatory-pump-tubing-set-fda-510k.jpg K905713 - BARD AMBULATORY PUMP TUBING SET K905713 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jul 1991. https://www.510kdatabase.net/k911685/ 1991-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k911685-ranawatburstein-porous-total-hip-fda-510k.jpg K911685 - RANAWAT/BURSTEIN POROUS TOTAL HIP FEMORAL COMP K911685 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jul 1991. https://www.510kdatabase.net/k911686/ 1991-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k911686-global-total-shoulder-uncement-humeral-fda-510k.jpg K911686 - GLOBAL TOTAL SHOULDER, UNCEMENT HUMERAL HEMI-SHOUL K911686 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jul 1991. https://www.510kdatabase.net/k912649/ 1991-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k912649-isek-fda-510k.jpg K912649 - ISE/K+ K912649 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jul 1991. https://www.510kdatabase.net/k905778/ 1991-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k905778-epidural-indication-for-baxter-fda-510k.jpg K905778 - EPIDURAL INDICATION FOR BAXTER INFUSORS ATTACHMENT K905778 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jul 1991. https://www.510kdatabase.net/k910429/ 1991-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k910429-swan-ganz-flow-directed-pressure-td-fda-510k.jpg K910429 - SWAN-GANZ FLOW DIRECTED PRESSURE TD CATHETER K910429 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jul 1991. https://www.510kdatabase.net/k905698/ 1991-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k905698-cordis-opta-5-fda-510k.jpg K905698 - CORDIS OPTA 5 K905698 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Jul 1991. https://www.510kdatabase.net/k911606/ 1991-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k911606-baxter-preoperative-skin-prep-tray-fda-510k.jpg K911606 - BAXTER PREOPERATIVE SKIN PREP TRAY W/FOAM SPONGES K911606 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jul 1991. https://www.510kdatabase.net/k911632/ 1991-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k911632-capioxr-bubble-trap-fda-510k.jpg K911632 - CAPIOX(R) BUBBLE TRAP K911632 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Jul 1991. https://www.510kdatabase.net/k905798/ 1991-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k905798-colocare-fda-510k.jpg K905798 - COLOCARE K905798 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Jul 1991. https://www.510kdatabase.net/k910967/ 1991-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k910967-neurocam-fda-510k.jpg K910967 - NEUROCAM K910967 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Jul 1991. https://www.510kdatabase.net/k911075/ 1991-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k911075-coloscreen-fda-510k.jpg K911075 - COLOSCREEN K911075 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Jul 1991. https://www.510kdatabase.net/k911272/ 1991-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k911272-endoscopic-needlholder-cat-number-114705-fda-510k.jpg K911272 - ENDOSCOPIC NEEDLHOLDER CAT. NUMBER 114705 K911272 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Edward Weck, Inc.. Cleared Jul 1991. https://www.510kdatabase.net/k911572/ 1991-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k911572-mg-ii-porous-cobal-t-chrome-femoral-fda-510k.jpg K911572 - MG II POROUS COBAL T-CHROME FEMORAL COMPONENT K911572 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jul 1991. https://www.510kdatabase.net/k911585/ 1991-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k911585-omnifit-ii-epf-hip-stem-series-fda-510k.jpg K911585 - OMNIFIT II EPF HIP STEM SERIES K911585 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Jul 1991. https://www.510kdatabase.net/k911771/ 1991-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k911771-ardtm-antimicrobial-removal-device-fda-510k.jpg K911771 - ARD(TM) ANTIMICROBIAL REMOVAL DEVICE K911771 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jul 1991. https://www.510kdatabase.net/k912217/ 1991-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k912217-kodak-ektachem-clinical-chemistry-slides-fda-510k.jpg K912217 - KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES K912217 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Jul 1991. https://www.510kdatabase.net/k912413/ 1991-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k912413-chem-link-data-base-manager-fda-510k.jpg K912413 - CHEM-LINK DATA BASE MANAGER K912413 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Jul 1991. https://www.510kdatabase.net/k912534/ 1991-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k912534-imx-hcg-fda-510k.jpg K912534 - IMX HCG K912534 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jul 1991. https://www.510kdatabase.net/k912535/ 1991-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k912535-imx-total-b-hcg-fda-510k.jpg K912535 - IMX TOTAL B-HCG K912535 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jul 1991. https://www.510kdatabase.net/k904809/ 1991-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k904809-universal-compression-screw-fda-510k.jpg K904809 - UNIVERSAL COMPRESSION SCREW K904809 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jun 1991. https://www.510kdatabase.net/k905594/ 1991-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k905594-neurofile-data-storageaccesories-to-fda-510k.jpg K905594 - NEUROFILE DATA STORAGE/ACCESORIES TO THE EEG-4300 K905594 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Jun 1991. https://www.510kdatabase.net/k911244/ 1991-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k911244-vlc-glass-ionomer-liner-fda-510k.jpg K911244 - VLC GLASS IONOMER LINER K911244 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jun 1991. https://www.510kdatabase.net/k911412/ 1991-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k911412-olympus-disposable-biopsy-valve-fda-510k.jpg K911412 - OLYMPUS DISPOSABLE BIOPSY VALVE K911412 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Olympus Corp.. Cleared Jun 1991. https://www.510kdatabase.net/k911703/ 1991-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k911703-cordis-8-french-0084-id-ptca-guiding-fda-510k.jpg K911703 - CORDIS 8 FRENCH 0.084 I.D. PTCA GUIDING CATHETER K911703 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Jun 1991. https://www.510kdatabase.net/k911806/ 1991-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k911806-magnetic-resonance-diagnostic-accessory-fda-510k.jpg K911806 - MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY K911806 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jun 1991. https://www.510kdatabase.net/k910807/ 1991-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k910807-keane-uni-knee-system-fda-510k.jpg K910807 - KEANE UNI KNEE SYSTEM K910807 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jun 1991. https://www.510kdatabase.net/k911398/ 1991-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k911398-asnis-2-small-diameter-cannulated-fda-510k.jpg K911398 - ASNIS 2 SMALL DIAMETER CANNULATED SCREW SYSTEM K911398 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jun 1991. https://www.510kdatabase.net/k911684/ 1991-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k911684-biomet-cobalt-chrome-femoral-components-fda-510k.jpg K911684 - BIOMET COBALT-CHROME FEMORAL COMPONENTS K911684 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jun 1991. https://www.510kdatabase.net/k911373/ 1991-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k911373-osteonics-ion-implant-mod-ml-uniknee-fda-510k.jpg K911373 - OSTEONICS ION IMPLANT MOD-ML UNIKNEE FEMORAL COMP K911373 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Jun 1991. https://www.510kdatabase.net/k910116/ 1991-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k910116-turbo-support-catheter-fda-510k.jpg K910116 - TURBO SUPPORT CATHETER K910116 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Jun 1991. https://www.510kdatabase.net/k904890/ 1991-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k904890-bard-alfentanil-infuser-fda-510k.jpg K904890 - BARD ALFENTANIL INFUSER K904890 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jun 1991. https://www.510kdatabase.net/k910934/ 1991-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k910934-flo-gard-6300-dual-channel-volumetric-fda-510k.jpg K910934 - FLO-GARD 6300 DUAL CHANNEL VOLUMETRIC INFUSION PUM K910934 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jun 1991. https://www.510kdatabase.net/k911868/ 1991-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k911868-interlinktm-blunt-cannula-modification-fda-510k.jpg K911868 - INTERLINK(TM) BLUNT CANNULA, MODIFICATION K911868 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jun 1991. https://www.510kdatabase.net/k905083/ 1991-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k905083-45f-imagecath-angioscope-fda-510k.jpg K905083 - 4.5F IMAGECATH ANGIOSCOPE K905083 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jun 1991. https://www.510kdatabase.net/k910235/ 1991-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k910235-pca-mtk-ii-total-knee-system-fda-510k.jpg K910235 - PCA MTK II TOTAL KNEE SYSTEM K910235 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jun 1991. https://www.510kdatabase.net/k910592/ 1991-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k910592-abuscreen-fp-for-cannabinoids-15-50-fda-510k.jpg K910592 - ABUSCREEN FP FOR CANNABINOIDS (15-50) K910592 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jun 1991. https://www.510kdatabase.net/k911262/ 1991-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k911262-disposable-specimen-bag-wcannula-and-fda-510k.jpg K911262 - DISPOSABLE SPECIMEN BAG W/CANNULA AND INTRODUCER K911262 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Jun 1991. https://www.510kdatabase.net/k912241/ 1991-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k912241-stratusr-htsh-fluormetric-enzyme-fda-510k.jpg K912241 - STRATUS(R) HTSH FLUORMETRIC ENZYME IMMUNOASSAY K912241 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jun 1991. https://www.510kdatabase.net/k912324/ 1991-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k912324-neonatal-tsh-125i-immunoradiometric-fda-510k.jpg K912324 - NEONATAL TSH (125I) IMMUNORADIOMETRIC ASSAY K912324 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jun 1991. https://www.510kdatabase.net/k912601/ 1991-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k912601-biprobetm-fda-510k.jpg K912601 - BIPROBE(TM) K912601 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jun 1991. https://www.510kdatabase.net/k910990/ 1991-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k910990-osteonics-7000-series-total-knee-fda-510k.jpg K910990 - OSTEONICS 7000 SERIES TOTAL KNEE TIBIAL COMPONENTS K910990 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Jun 1991. https://www.510kdatabase.net/k911236/ 1991-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k911236-medtronic-permanent-lead-introducer-fda-510k.jpg K911236 - MEDTRONIC PERMANENT LEAD INTRODUCER, VARIOUS MDLS K911236 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jun 1991. https://www.510kdatabase.net/k911757/ 1991-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k911757-maxibond-fda-510k.jpg K911757 - MAXIBOND K911757 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jun 1991. https://www.510kdatabase.net/k911842/ 1991-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k911842-3m-luting-cement-paste-a-and-b-fda-510k.jpg K911842 - 3M LUTING CEMENT, PASTE A AND B K911842 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Jun 1991. https://www.510kdatabase.net/k911136/ 1991-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k911136-b-d-safety-loktm-iv-needles-fda-510k.jpg K911136 - B-D SAFETY-LOK(TM) I.V. NEEDLES K911136 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jun 1991. https://www.510kdatabase.net/k905774/ 1991-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k905774-thackray-titanium-mini-plating-system-fda-510k.jpg K905774 - THACKRAY TITANIUM MINI-PLATING SYSTEM K905774 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jun 1991. https://www.510kdatabase.net/k905056/ 1991-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k905056-percor-stat-dl-95-fr-wopt-insert-wo-fda-510k.jpg K905056 - PERCOR STAT-DL 9.5 FR W/OPT INSERT W/O INTRO SHEAT K905056 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Jun 1991. https://www.510kdatabase.net/k911139/ 1991-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k911139-hewlett-packard-models-m1400a-m1402a-fda-510k.jpg K911139 - HEWLETT-PACKARD MODELS M1400A, M1402A & M1401A K911139 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Jun 1991. https://www.510kdatabase.net/k911885/ 1991-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k911885-dader-protein-c-abnormal-contral-fda-510k.jpg K911885 - DADE(R) PROTEIN C ABNORMAL CONTRAL K911885 is a FDA 510(k) cleared hematology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jun 1991. https://www.510kdatabase.net/k912239/ 1991-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k912239-vzvscantm-latex-aggutination-test-fda-510k.jpg K912239 - VZVSCAN(TM) LATEX AGGUTINATION TEST K912239 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jun 1991. https://www.510kdatabase.net/k905500/ 1991-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k905500-myocardial-protection-system-fda-510k.jpg K905500 - MYOCARDIAL PROTECTION SYSTEM K905500 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jun 1991. https://www.510kdatabase.net/k910720/ 1991-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k910720-bard-biopty-cut-biopsy-needle-with-fda-510k.jpg K910720 - BARD BIOPTY-CUT BIOPSY NEEDLE WITH SPACER K910720 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jun 1991. https://www.510kdatabase.net/k911310/ 1991-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k911310-corometrics-5566aax-noninvasive-blood-fda-510k.jpg K911310 - COROMETRICS 5566AAX NONINVASIVE BLOOD PRESSURE MOD K911310 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Jun 1991. https://www.510kdatabase.net/k911347/ 1991-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k911347-lyphochekr-hemoglobin-a2-control-fda-510k.jpg K911347 - LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL K911347 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bio-Rad. Cleared Jun 1991. https://www.510kdatabase.net/k911367/ 1991-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k911367-baxter-marathontm-intravascular-relay-fda-510k.jpg K911367 - BAXTER MARATHON(TM) INTRAVASCULAR RELAY GUID CATH K911367 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jun 1991. https://www.510kdatabase.net/k911854/ 1991-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k911854-dade-liid-trol-tl-tri-level-lipid-fda-510k.jpg K911854 - DADE LIID-TROL TL TRI-LEVEL LIPID CONTROL K911854 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jun 1991. https://www.510kdatabase.net/k912016/ 1991-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k912016-il-phoenixtm-model-905-chemelect-fda-510k.jpg K912016 - IL PHOENIX(TM), MODEL 905 CHEM/ELECT ANALYZER K912016 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jun 1991. https://www.510kdatabase.net/k912055/ 1991-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k912055-syva-edms-fda-510k.jpg K912055 - SYVA EDMS K912055 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Jun 1991. https://www.510kdatabase.net/k910156/ 1991-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k910156-hydroxyapatite-coated-profiler-hip-stem-fda-510k.jpg K910156 - HYDROXYAPATITE COATED PROFILE(R) HIP STEM K910156 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jun 1991. https://www.510kdatabase.net/k910715/ 1991-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k910715-vista-hpq-system-fda-510k.jpg K910715 - VISTA HPQ SYSTEM K910715 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Jun 1991. https://www.510kdatabase.net/k911711/ 1991-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k911711-kodak-automatic-film-feeder-model-ra-fda-510k.jpg K911711 - KODAK AUTOMATIC FILM FEEDER, MODEL RA K911711 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Jun 1991. https://www.510kdatabase.net/k911713/ 1991-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k911713-kodak-100-j-100-k-chemical-mixers-fda-510k.jpg K911713 - KODAK 100-J & 100-K CHEMICAL MIXERS K911713 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Jun 1991. https://www.510kdatabase.net/k911714/ 1991-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k911714-kodak-m35-mx-0mat-processor-fda-510k.jpg K911714 - KODAK M35-MX-0MAT PROCESSOR K911714 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Jun 1991. https://www.510kdatabase.net/k905788/ 1991-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k905788-model-m1251a-mon-full-disclosure-fda-510k.jpg K905788 - MODEL M1251A MON. FULL DISCLOSURE REVIEW SYSTEM K905788 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Jun 1991. https://www.510kdatabase.net/k910165/ 1991-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k910165-cuttersil-mucosa-fda-510k.jpg K910165 - CUTTERSIL MUCOSA K910165 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Jun 1991. https://www.510kdatabase.net/k910166/ 1991-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k910166-cuttersil-xl-fda-510k.jpg K910166 - CUTTERSIL XL K910166 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Jun 1991. https://www.510kdatabase.net/k910189/ 1991-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k910189-perfourm-putty-soft-fda-510k.jpg K910189 - PERFOURM PUTTY SOFT K910189 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Jun 1991. https://www.510kdatabase.net/k910360/ 1991-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k910360-cuttersil-function-activator-fda-510k.jpg K910360 - CUTTERSIL FUNCTION ACTIVATOR K910360 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Jun 1991. https://www.510kdatabase.net/k910465/ 1991-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k910465-meliodent-denture-resin-fda-510k.jpg K910465 - MELIODENT, DENTURE RESIN K910465 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Jun 1991. https://www.510kdatabase.net/k912228/ 1991-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k912228-mark-5-robotic-pipettor-fda-510k.jpg K912228 - MARK 5 ROBOTIC PIPETTOR K912228 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jun 1991. https://www.510kdatabase.net/k910989/ 1991-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k910989-osteonics-ion-implanted-total-knee-fda-510k.jpg K910989 - OSTEONICS ION IMPLANTED TOTAL KNEE FEMORAL COMP K910989 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Jun 1991. https://www.510kdatabase.net/k910933/ 1991-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k910933-olympus-angioscopy-irrigation-sheath-fda-510k.jpg K910933 - OLYMPUS ANGIOSCOPY IRRIGATION SHEATH K910933 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Olympus Corp.. Cleared Jun 1991. https://www.510kdatabase.net/k911725/ 1991-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k911725-acar-urine-phencyclidine-u-pcp-screen-fda-510k.jpg K911725 - ACA(R) URINE PHENCYCLIDINE (U PCP) SCREEN METHOD K911725 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Jun 1991. https://www.510kdatabase.net/k910024/ 1991-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k910024-volumetric-infusion-pump-fda-510k.jpg K910024 - VOLUMETRIC INFUSION PUMP K910024 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared May 1991. https://www.510kdatabase.net/k912214/ 1991-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k912214-bard-singular-biopsy-forceps-fda-510k.jpg K912214 - BARD SINGULAR BIOPSY FORCEPS K912214 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 1991. https://www.510kdatabase.net/k910873/ 1991-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k910873-bd-angiographic-syringe-wa-rotating-tip-fda-510k.jpg K910873 - BD ANGIOGRAPHIC SYRINGE W/A ROTATING TIP K910873 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared May 1991. https://www.510kdatabase.net/k911751/ 1991-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k911751-medtrack-treadmill-fda-510k.jpg K911751 - MEDTRACK TREADMILL K911751 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Quinton, Inc.. Cleared May 1991. https://www.510kdatabase.net/k911106/ 1991-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k911106-model-baxter-ultrafiltrate-meter-and-fda-510k.jpg K911106 - MODEL BAXTER ULTRAFILTRATE METER AND DRAIN BAG K911106 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared May 1991. https://www.510kdatabase.net/k911329/ 1991-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k911329-bardr-surecatch-pediatric-urine-fda-510k.jpg K911329 - BARD(R) SURECATCH PEDIATRIC URINE COLLECT DEVICE K911329 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 1991. https://www.510kdatabase.net/k911401/ 1991-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k911401-abbott-lifecare-5000-pump-fda-510k.jpg K911401 - ABBOTT LIFECARE 5000 PUMP K911401 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared May 1991. https://www.510kdatabase.net/k910869/ 1991-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k910869-howmedicar-cemeted-femoral-component-fda-510k.jpg K910869 - HOWMEDICA(R) CEMETED FEMORAL COMPONENT K910869 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared May 1991. https://www.510kdatabase.net/k910919/ 1991-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k910919-abbott-lifecare-5000-pump-modified-fda-510k.jpg K910919 - ABBOTT LIFECARE 5000 PUMP MODIFIED K910919 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared May 1991. https://www.510kdatabase.net/k911954/ 1991-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k911954-remeditm-drug-profiling-system-fda-510k.jpg K911954 - REMEDI(TM) DRUG PROFILING SYSTEM, MODIFICATION K911954 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bio-Rad. Cleared May 1991. https://www.510kdatabase.net/k911512/ 1991-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k911512-milenia-progesterone-fda-510k.jpg K911512 - MILENIA PROGESTERONE K911512 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared May 1991. https://www.510kdatabase.net/k911724/ 1991-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k911724-acar-urine-drugs-of-abuse-control-fda-510k.jpg K911724 - ACA(R) URINE DRUGS OF ABUSE CONTROL, MODIFICATION K911724 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared May 1991. https://www.510kdatabase.net/k911289/ 1991-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k911289-epidural-indication-for-baxter-syringe-fda-510k.jpg K911289 - EPIDURAL INDICATION FOR BAXTER SYRINGE INFUS PUMP K911289 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared May 1991. https://www.510kdatabase.net/k901485/ 1991-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k901485-enzygnost-anti-cmvigg-igm-fda-510k.jpg K901485 - ENZYGNOST ANTI-CMV/IGG + IGM K901485 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared May 1991. https://www.510kdatabase.net/k910680/ 1991-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k910680-epinephrine-reagent-cat-no-5367-fda-510k.jpg K910680 - EPINEPHRINE REAGENT, CAT. NO. 5367 K910680 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared May 1991. https://www.510kdatabase.net/k910706/ 1991-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k910706-collagen-reagent-cat-no-5368-fda-510k.jpg K910706 - COLLAGEN REAGENT CAT. NO. 5368 K910706 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared May 1991. https://www.510kdatabase.net/k910800/ 1991-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k910800-adp-reagent-fda-510k.jpg K910800 - ADP REAGENT K910800 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared May 1991. https://www.510kdatabase.net/k910859/ 1991-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k910859-computerized-tomography-x-ray-system-fda-510k.jpg K910859 - COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM K910859 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 1991. https://www.510kdatabase.net/k911437/ 1991-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k911437-kodak-ektascan-cable-extension-fda-510k.jpg K911437 - KODAK EKTASCAN CABLE EXTENSION K911437 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared May 1991. https://www.510kdatabase.net/k910688/ 1991-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k910688-cordis-peel-away-insertion-tool-fda-510k.jpg K910688 - CORDIS PEEL-AWAY INSERTION TOOL K910688 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared May 1991. https://www.510kdatabase.net/k911122/ 1991-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k911122-8mm-quantum-pulsesuprima-ii-pulse-fda-510k.jpg K911122 - 8MM QUANTUM PULSE/SUPRIMA II PULSE GENERATORS K911122 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared May 1991. https://www.510kdatabase.net/k905653/ 1991-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k905653-advantx-afm-angio-system-s1808-fda-510k.jpg K905653 - ADVANTX AFM ANGIO SYSTEM S1808 K905653 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared May 1991. https://www.510kdatabase.net/k911712/ 1991-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k911712-stratusr-automated-sample-handler-fda-510k.jpg K911712 - STRATUS(R) AUTOMATED SAMPLE HANDLER K911712 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Baxter Healthcare Corp. Cleared May 1991. https://www.510kdatabase.net/k910629/ 1991-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k910629-ap-860pa-nibp-module-fda-510k.jpg K910629 - AP-860PA NIBP MODULE K910629 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared May 1991. https://www.510kdatabase.net/k905404/ 1991-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k905404-medtronic-sullivan-nasal-cpap-system-fda-510k.jpg K905404 - MEDTRONIC SULLIVAN NASAL CPAP SYSTEM K905404 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Medtronic Vascular. Cleared May 1991. https://www.510kdatabase.net/k910662/ 1991-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k910662-ps-omnifit-normalized-hip-stem-series-fda-510k.jpg K910662 - PS OMNIFIT NORMALIZED HIP STEM SERIES K910662 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared May 1991. https://www.510kdatabase.net/k911913/ 1991-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k911913-precision-glide-enhanced-surgical-blade-fda-510k.jpg K911913 - PRECISION GLIDE - ENHANCED SURGICAL BLADE K911913 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared May 1991. https://www.510kdatabase.net/k910180/ 1991-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k910180-bacti-swab-fda-510k.jpg K910180 - BACTI-SWAB K910180 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared May 1991. https://www.510kdatabase.net/k911387/ 1991-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k911387-ct-sytec-4000-fda-510k.jpg K911387 - CT SYTEC 4000 K911387 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared May 1991. https://www.510kdatabase.net/k905658/ 1991-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k905658-systemate-creatinine-epos-application-fda-510k.jpg K905658 - SYSTEMATE CREATININE (EPOS APPLICATION) #65413 K905658 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared May 1991. https://www.510kdatabase.net/k910553/ 1991-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k910553-roche-apolipoprotein-standard-fda-510k.jpg K910553 - ROCHE APOLIPOPROTEIN STANDARD K910553 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared May 1991. https://www.510kdatabase.net/k910754/ 1991-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k910754-model-43100a-series-defibrillator-fda-510k.jpg K910754 - MODEL 43100A SERIES DEFIBRILLATOR, MODIFICATION K910754 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared May 1991. https://www.510kdatabase.net/k910551/ 1991-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k910551-roche-reagent-for-apolipoprotein-a-1-fda-510k.jpg K910551 - ROCHE REAGENT FOR APOLIPOPROTEIN A-1 K910551 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared May 1991. https://www.510kdatabase.net/k910552/ 1991-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k910552-roche-reagent-for-apolipoprotein-b-fda-510k.jpg K910552 - ROCHE REAGENT FOR APOLIPOPROTEIN B K910552 is a FDA 510(k) cleared immunology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared May 1991. https://www.510kdatabase.net/k910595/ 1991-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k910595-model-5311b-a-v-pacing-system-analyzer-fda-510k.jpg K910595 - MODEL 5311B A-V PACING SYSTEM ANALYZER K910595 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared May 1991. https://www.510kdatabase.net/k910834/ 1991-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k910834-qbc-autoreader-fda-510k.jpg K910834 - QBC AUTOREADER K910834 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared May 1991. https://www.510kdatabase.net/k911140/ 1991-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k911140-bardr-endocardial-balloon-array-fda-510k.jpg K911140 - BARD(R) ENDOCARDIAL BALLOON ARRAY K911140 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 1991. https://www.510kdatabase.net/k911266/ 1991-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k911266-modified-pk-tp-control-fda-510k.jpg K911266 - MODIFIED PK TP CONTROL K911266 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Olympus Corp.. Cleared May 1991. https://www.510kdatabase.net/k910500/ 1991-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k910500-howmedica-kinemax-plus-total-knee-system-fda-510k.jpg K910500 - HOWMEDICA KINEMAX PLUS TOTAL KNEE SYSTEM K910500 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared May 1991. https://www.510kdatabase.net/k910653/ 1991-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k910653-touchless-ii-intermittent-catheter-fda-510k.jpg K910653 - TOUCHLESS II INTERMITTENT CATHETER K910653 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 1991. https://www.510kdatabase.net/k911082/ 1991-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k911082-real-time-x-ray-imaging-system-fda-510k.jpg K911082 - REAL TIME X-RAY IMAGING SYSTEM K911082 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 1991. https://www.510kdatabase.net/k903345/ 1991-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k903345-bard-r-lubricious-coated-ureteral-fda-510k.jpg K903345 - BARD (R) LUBRICIOUS - COATED URETERAL STENT SUTURE K903345 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 1991. https://www.510kdatabase.net/k910467/ 1991-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k910467-argiplus-fda-510k.jpg K910467 - ARGIPLUS K910467 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Apr 1991. https://www.510kdatabase.net/k900880/ 1991-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k900880-olympus-jf-um3-75-12-and-cf-um3-75-12-fda-510k.jpg K900880 - OLYMPUS JF-UM3-7.5/-12 AND CF-UM3-7.5/-12 K900880 is a FDA 510(k) cleared radiology medical device. Manufacturer: Olympus Corp.. Cleared Apr 1991. https://www.510kdatabase.net/k905702/ 1991-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k905702-new-triad-transheet-denture-base-fda-510k.jpg K905702 - NEW TRIAD TRANSHEET DENTURE BASE MATERIAL K905702 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Apr 1991. https://www.510kdatabase.net/k910423/ 1991-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k910423-bronchoscope-bf-n20-fda-510k.jpg K910423 - BRONCHOSCOPE BF-N20 K910423 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Olympus Corp.. Cleared Apr 1991. https://www.510kdatabase.net/k910741/ 1991-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k910741-heparin-controls-high-and-low-fda-510k.jpg K910741 - HEPARIN CONTROLS, HIGH AND LOW K910741 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Apr 1991. https://www.510kdatabase.net/k911309/ 1991-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k911309-ust-974-5-convex-transducer-fda-510k.jpg K911309 - UST-974-5 CONVEX TRANSDUCER K911309 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Apr 1991. https://www.510kdatabase.net/k910490/ 1991-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k910490-modified-monitoring-system-models-fda-510k.jpg K910490 - MODIFIED MONITORING SYSTEM MODELS M1175A & M1176A K910490 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Apr 1991. https://www.510kdatabase.net/k911245/ 1991-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k911245-eudermic-surgical-gloves-fda-510k.jpg K911245 - EUDERMIC SURGICAL GLOVES K911245 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1991. https://www.510kdatabase.net/k911411/ 1991-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k911411-bard-3000-plus-ureteroscopy-system-fda-510k.jpg K911411 - BARD 3000 PLUS URETEROSCOPY SYSTEM K911411 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 1991. https://www.510kdatabase.net/k910204/ 1991-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k910204-swan-ganzr-hi-shorer-thermo-cath-wamctm-fda-510k.jpg K910204 - SWAN-GANZ(R) HI-SHORE(R) THERMO CATH W/AMC(TM) K910204 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Apr 1991. https://www.510kdatabase.net/k910591/ 1991-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k910591-roche-reagent-for-total-bilirubin-fda-510k.jpg K910591 - ROCHE REAGENT FOR TOTAL BILIRUBIN K910591 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Apr 1991. https://www.510kdatabase.net/k910593/ 1991-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k910593-roche-reagent-for-direct-bilirubin-fda-510k.jpg K910593 - ROCHE REAGENT FOR DIRECT BILIRUBIN K910593 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Apr 1991. https://www.510kdatabase.net/k910853/ 1991-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k910853-graduated-cylinder-of-external-fda-510k.jpg K910853 - GRADUATED CYLINDER OF EXTERNAL DRAINAGE SET K910853 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cordis Corp.. Cleared Apr 1991. https://www.510kdatabase.net/k910817/ 1991-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k910817-ge-quadrature-cervical-spine-surf-coil-fda-510k.jpg K910817 - GE QUADRATURE CERVICAL SPINE SURF COIL, M1285AR K910817 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Apr 1991. https://www.510kdatabase.net/k911405/ 1991-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k911405-kodak-ektascan-digital-interfacefor-att-fda-510k.jpg K911405 - KODAK EKTASCAN DIGITAL INTERFACE/FOR AT&T K911405 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Apr 1991. https://www.510kdatabase.net/k903948/ 1991-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k903948-intermedics-model-431-11-implant-fda-510k.jpg K903948 - INTERMEDICS MODEL 431-11 IMPLANT ENDOCARD PAC LEAD K903948 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Apr 1991. https://www.510kdatabase.net/k904832/ 1991-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k904832-modified-syst-sonos-5001000-ultrsound-fda-510k.jpg K904832 - MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST K904832 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Apr 1991. https://www.510kdatabase.net/k910291/ 1991-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k910291-model-43420b-newwave-holter-fda-510k.jpg K910291 - MODEL 43420B NEWWAVE HOLTER SYSTEM/MODIFICATION K910291 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Apr 1991. https://www.510kdatabase.net/k902613/ 1991-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k902613-bard-pca-ii-pump-with-program-cartridges-fda-510k.jpg K902613 - BARD PCA II PUMP WITH PROGRAM CARTRIDGES K902613 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 1991. https://www.510kdatabase.net/k910479/ 1991-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k910479-argyle-polyurethane-salem-sump-tube-fda-510k.jpg K910479 - ARGYLE POLYURETHANE SALEM SUMP TUBE K910479 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Sherwood Medical Co.. Cleared Apr 1991. https://www.510kdatabase.net/k910270/ 1991-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k910270-premixed-dialysate-for-hemodiafiltration-fda-510k.jpg K910270 - PREMIXED DIALYSATE FOR HEMODIAFILTRATION K910270 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Apr 1991. https://www.510kdatabase.net/k910630/ 1991-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k910630-model-6985m-temporary-unipolar-lead-fda-510k.jpg K910630 - MODEL 6985M TEMPORARY UNIPOLAR LEAD EXTENDER KIT K910630 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Apr 1991. https://www.510kdatabase.net/k911048/ 1991-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k911048-model-5857-3m-lead-end-cap-kit-fda-510k.jpg K911048 - MODEL 5857-3M LEAD END CAP KIT K911048 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Apr 1991. https://www.510kdatabase.net/k894227/ 1991-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k894227-allergen-modules-for-alastat-tm-fda-510k.jpg K894227 - ALLERGEN MODULES FOR ALASTAT TM K894227 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Apr 1991. https://www.510kdatabase.net/k911511/ 1991-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k911511-alastat-allergen-specified-ige-system-fda-510k.jpg K911511 - ALASTAT ALLERGEN SPECIFIED IGE SYSTEM, MODIFIED K911511 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Apr 1991. https://www.510kdatabase.net/k905807/ 1991-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k905807-helena-thromboplastin-reagent-with-fda-510k.jpg K905807 - HELENA THROMBOPLASTIN REAGENT WITH DILUENT K905807 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Apr 1991. https://www.510kdatabase.net/k910213/ 1991-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k910213-nutrimixr-macrotm-tpn-fda-510k.jpg K910213 - NUTRIMIX(R) MACRO(TM) TPN COMPOUNDER/MODIFICATION K910213 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1991. https://www.510kdatabase.net/k910716/ 1991-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k910716-model-214400-combination-endo-surgical-fda-510k.jpg K910716 - MODEL 2144.00 COMBINATION ENDO-SURGICAL DEVICE K910716 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Apr 1991. https://www.510kdatabase.net/k911094/ 1991-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k911094-inpersol-capd-biocap-administration-set-fda-510k.jpg K911094 - INPERSOL CAPD BIOCAP ADMINISTRATION SET K911094 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1991. https://www.510kdatabase.net/k911468/ 1991-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k911468-rep-spe-plus-acid-blue-system-fda-510k.jpg K911468 - REP SPE PLUS (ACID BLUE) SYSTEM K911468 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Apr 1991. https://www.510kdatabase.net/k905687/ 1991-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k905687-zirconia-ceramic-modular-heads-fda-510k.jpg K905687 - ZIRCONIA CERAMIC MODULAR HEADS K905687 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Apr 1991. https://www.510kdatabase.net/k904752/ 1991-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k904752-chemstripr-micraltm-urine-test-strips-fda-510k.jpg K904752 - CHEMSTRIP(R) MICRAL(TM) URINE TEST STRIPS K904752 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Apr 1991. https://www.510kdatabase.net/k910535/ 1991-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k910535-synchron-c-reactive-protein-reagent-fda-510k.jpg K910535 - SYNCHRON C-REACTIVE PROTEIN REAGENT K910535 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Apr 1991. https://www.510kdatabase.net/k910639/ 1991-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k910639-systemate-alkaline-phosphataseepos-fda-510k.jpg K910639 - SYSTEMATE ALKALINE PHOSPHATASE(EPOS APPL) #65483 K910639 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Apr 1991. https://www.510kdatabase.net/k910640/ 1991-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k910640-systemate-lactate-dehydrogenase-epos-fda-510k.jpg K910640 - SYSTEMATE LACTATE DEHYDROGENASE (EPOS APPL) #65476 K910640 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Apr 1991. https://www.510kdatabase.net/k910107/ 1991-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k910107-duraflo-ii-heparin-oxygenator-model-fda-510k.jpg K910107 - DURAFLO II HEPARIN OXYGENATOR MODEL UNIVOX GOLD K910107 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Apr 1991. https://www.510kdatabase.net/k905102/ 1991-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k905102-bardr-syringe-assist-irrigation-fda-510k.jpg K905102 - BARD(R) SYRINGE ASSIST IRRIGATION K905102 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 1991. https://www.510kdatabase.net/k910154/ 1991-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k910154-usci-illumen-8-8f-ptca-guiding-catheter-fda-510k.jpg K910154 - USCI ILLUMEN-8 8F PTCA GUIDING CATHETER K910154 is a FDA 510(k) cleared toxicology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 1991. https://www.510kdatabase.net/k910568/ 1991-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k910568-model-5866-46-sleeve-kit-fda-510k.jpg K910568 - MODEL 5866-46 SLEEVE KIT K910568 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Apr 1991. https://www.510kdatabase.net/k910923/ 1991-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k910923-bcd-advanced-fda-510k.jpg K910923 - BCD ADVANCED K910923 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Apr 1991. https://www.510kdatabase.net/k910995/ 1991-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k910995-medi-tech-balloon-dilatation-catheter-fda-510k.jpg K910995 - MEDI-TECH BALLOON DILATATION CATHETER K910995 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Apr 1991. https://www.510kdatabase.net/k911203/ 1991-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k911203-tegwire-tm-fda-510k.jpg K911203 - TEGWIRE (TM) K911203 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Apr 1991. https://www.510kdatabase.net/k910428/ 1991-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k910428-epidural-indication-for-volumetric-fda-510k.jpg K910428 - EPIDURAL INDICATION FOR VOLUMETRIC INFUSION PUMPS K910428 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Apr 1991. https://www.510kdatabase.net/k910461/ 1991-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k910461-osteonicsr-mid-shaft-cement-spacer-fda-510k.jpg K910461 - OSTEONICS(R) MID-SHAFT CEMENT SPACER K910461 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Apr 1991. https://www.510kdatabase.net/k910534/ 1991-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k910534-synchron-lactate-reagent-fda-510k.jpg K910534 - SYNCHRON LACTATE REAGENT K910534 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Apr 1991. https://www.510kdatabase.net/k910683/ 1991-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k910683-enzymun-test-progesterone-fda-510k.jpg K910683 - ENZYMUN-TEST PROGESTERONE K910683 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Apr 1991. https://www.510kdatabase.net/k904254/ 1991-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k904254-na-alpha-1-microglobulin-kit-fda-510k.jpg K904254 - NA ALPHA 1 MICROGLOBULIN KIT K904254 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Apr 1991. https://www.510kdatabase.net/k910590/ 1991-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k910590-abuscreen-ontrak-for-benzodiazepine-fda-510k.jpg K910590 - ABUSCREEN ONTRAK FOR BENZODIAZEPINE K910590 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Apr 1991. https://www.510kdatabase.net/k910922/ 1991-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k910922-osteonics-cdh-hip-stem-fda-510k.jpg K910922 - OSTEONICS CDH HIP STEM K910922 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Apr 1991. https://www.510kdatabase.net/k904935/ 1991-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k904935-respironics-digital-manometer-fda-510k.jpg K904935 - RESPIRONICS' DIGITAL MANOMETER K904935 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Apr 1991. https://www.510kdatabase.net/k905740/ 1991-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k905740-resorbable-bone-plug-fda-510k.jpg K905740 - RESORBABLE BONE PLUG K905740 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Zimmer, Inc.. Cleared Apr 1991. https://www.510kdatabase.net/k910185/ 1991-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k910185-synchron-cx4-cx5-and-cx7-clinical-fda-510k.jpg K910185 - SYNCHRON CX4, CX5, AND CX7 CLINICAL ANALYZER K910185 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Apr 1991. https://www.510kdatabase.net/k910255/ 1991-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k910255-flow-cytometry-fitcpe-compensation-kit-fda-510k.jpg K910255 - FLOW CYTOMETRY FITC/PE COMPENSATION KIT K910255 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Apr 1991. https://www.510kdatabase.net/k910278/ 1991-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k910278-abuscreenr-ontraktm-for-amphetamine500-fda-510k.jpg K910278 - ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINE(500 NG/ML) K910278 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Apr 1991. https://www.510kdatabase.net/k910355/ 1991-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k910355-il-phenobarbital-assay-system-fda-510k.jpg K910355 - IL PHENOBARBITAL ASSAY SYSTEM K910355 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Apr 1991. https://www.510kdatabase.net/k910589/ 1991-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k910589-abuscreen-fp-for-cannabinoids-50-100-fda-510k.jpg K910589 - ABUSCREEN FP FOR CANNABINOIDS (50-100) K910589 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Apr 1991. https://www.510kdatabase.net/k910658/ 1991-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k910658-abuscreen-ontrak-for-methamphetamine-fda-510k.jpg K910658 - ABUSCREEN ONTRAK FOR METHAMPHETAMINE K910658 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Apr 1991. https://www.510kdatabase.net/k910697/ 1991-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k910697-il-theophylline-assay-system-fda-510k.jpg K910697 - IL THEOPHYLLINE ASSAY SYSTEM K910697 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Apr 1991. https://www.510kdatabase.net/k910829/ 1991-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k910829-lyphochek-benzotca-control-serum-fda-510k.jpg K910829 - LYPHOCHEK BENZO/TCA CONTROL SERUM, LEVELS 1 AND 2 K910829 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bio-Rad. Cleared Apr 1991. https://www.510kdatabase.net/k911056/ 1991-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k911056-du-pont-dimensionr-phenytoin-ptn-method-fda-510k.jpg K911056 - DU PONT DIMENSION(R) PHENYTOIN (PTN) METHOD K911056 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Apr 1991. https://www.510kdatabase.net/k910931/ 1991-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k910931-biliary-balloon-dilatation-catheter-fda-510k.jpg K910931 - BILIARY BALLOON DILATATION CATHETER K910931 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Apr 1991. https://www.510kdatabase.net/k904208/ 1991-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k904208-kinemax-superstabilizer-total-knee-fda-510k.jpg K904208 - KINEMAX SUPERSTABILIZER TOTAL KNEE SYSTEM K904208 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Apr 1991. https://www.510kdatabase.net/k904475/ 1991-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k904475-entree-sheath-introducer-system-fda-510k.jpg K904475 - ENTREE SHEATH INTRODUCER SYSTEM K904475 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Apr 1991. https://www.510kdatabase.net/k910083/ 1991-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k910083-omnifit-total-knee-bone-augmentation-fda-510k.jpg K910083 - OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES K910083 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Apr 1991. https://www.510kdatabase.net/k910208/ 1991-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k910208-baxter-marathonr-intravascular-guiding-fda-510k.jpg K910208 - BAXTER MARATHON(R) INTRAVASCULAR GUIDING CATHETERS K910208 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Apr 1991. https://www.510kdatabase.net/k910425/ 1991-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k910425-large-volume-elastomeric-infusion-fda-510k.jpg K910425 - LARGE VOLUME ELASTOMERIC INFUSION DEVICE ATTACH. K910425 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Apr 1991. https://www.510kdatabase.net/k910106/ 1991-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k910106-datascope-multinex-id-monitor-fda-510k.jpg K910106 - DATASCOPE MULTINEX ID MONITOR K910106 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Datascope Corp.. Cleared Mar 1991. https://www.510kdatabase.net/k910153/ 1991-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k910153-ust-974-5-convex-transducer-fda-510k.jpg K910153 - UST-974-5 CONVEX TRANSDUCER K910153 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Mar 1991. https://www.510kdatabase.net/k910309/ 1991-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k910309-paramaxr-electrolyte-calibrator-fda-510k.jpg K910309 - PARAMAX(R) ELECTROLYTE CALIBRATOR 1&2/MODIFICATION K910309 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 1991. https://www.510kdatabase.net/k910524/ 1991-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k910524-surgical-clipper-fda-510k.jpg K910524 - SURGICAL CLIPPER K910524 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 1991. https://www.510kdatabase.net/k904799/ 1991-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k904799-chf-b20-choledochoscope-fda-510k.jpg K904799 - CHF-B20 CHOLEDOCHOSCOPE K904799 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Corp.. Cleared Mar 1991. https://www.510kdatabase.net/k904800/ 1991-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k904800-sif-sw-fda-510k.jpg K904800 - SIF-SW K904800 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Corp.. Cleared Mar 1991. https://www.510kdatabase.net/k910196/ 1991-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k910196-bard-hydrogel-coated-diagnostic-fda-510k.jpg K910196 - BARD HYDROGEL-COATED DIAGNOSTIC URETHRAL CATHETERS K910196 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 1991. https://www.510kdatabase.net/k905786/ 1991-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k905786-global-total-shoulder-fda-510k.jpg K905786 - GLOBAL TOTAL SHOULDER K905786 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Mar 1991. https://www.510kdatabase.net/k910464/ 1991-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k910464-gore-texr-expanded-ptfe-surgical-fda-510k.jpg K910464 - GORE-TEX(R) EXPANDED PTFE SURGICAL MEMBRANE K910464 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Mar 1991. https://www.510kdatabase.net/k910988/ 1991-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k910988-osteonics-ion-implanted-femoral-fda-510k.jpg K910988 - OSTEONICS ION IMPLANTED FEMORAL BEARING SERIES K910988 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Mar 1991. https://www.510kdatabase.net/k896520/ 1991-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k896520-owens-catheter-fda-510k.jpg K896520 - OWENS CATHETER K896520 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Mar 1991. https://www.510kdatabase.net/k905412/ 1991-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k905412-esultra-display-and-processing-station-fda-510k.jpg K905412 - ES/ULTRA DISPLAY AND PROCESSING STATION K905412 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Mar 1991. https://www.510kdatabase.net/k910498/ 1991-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k910498-magnetom-42-sp-and-63-sp-fda-510k.jpg K910498 - MAGNETOM 42 SP AND 63 SP K910498 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 1991. https://www.510kdatabase.net/k904668/ 1991-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k904668-ie-magnetic-extractor-fda-510k.jpg K904668 - IE MAGNETIC EXTRACTOR K904668 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Corp.. Cleared Mar 1991. https://www.510kdatabase.net/k910008/ 1991-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k910008-endothred-adjustable-stabilitly-theread-fda-510k.jpg K910008 - ENDOTHRED ADJUSTABLE STABILITLY THEREAD K910008 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ethicon, Inc.. Cleared Mar 1991. https://www.510kdatabase.net/k910523/ 1991-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k910523-modified-volumetric-infusion-pumps-fda-510k.jpg K910523 - MODIFIED VOLUMETRIC INFUSION PUMPS ATTACHMENTS K910523 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 1991. https://www.510kdatabase.net/k910793/ 1991-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k910793-reconstitution-device-fda-510k.jpg K910793 - RECONSTITUTION DEVICE K910793 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 1991. https://www.510kdatabase.net/k905614/ 1991-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k905614-jackson-pratt-high-lubricity-and-wound-fda-510k.jpg K905614 - JACKSON-PRATT, HIGH LUBRICITY AND WOUND DRAINS K905614 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 1991. https://www.510kdatabase.net/k910110/ 1991-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k910110-triple-layer-fluid-resistant-molded-fda-510k.jpg K910110 - TRIPLE LAYER FLUID-RESISTANT MOLDED FACE MASK K910110 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Mar 1991. https://www.510kdatabase.net/k902550/ 1991-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k902550-eeg-5400-series-fda-510k.jpg K902550 - EEG-5400 SERIES K902550 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Mar 1991. https://www.510kdatabase.net/k910332/ 1991-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k910332-flexiflo-sacks-vine-gastrostomy-kits-fda-510k.jpg K910332 - FLEXIFLO SACKS-VINE GASTROSTOMY KITS K910332 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1991. https://www.510kdatabase.net/k910875/ 1991-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k910875-endopath-disposable-pneumoperitoneum-fda-510k.jpg K910875 - ENDOPATH DISPOSABLE PNEUMOPERITONEUM NEEDLE K910875 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Mar 1991. https://www.510kdatabase.net/k904669/ 1991-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k904669-balloon-catheters-fda-510k.jpg K904669 - BALLOON CATHETERS K904669 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Corp.. Cleared Mar 1991. https://www.510kdatabase.net/k904859/ 1991-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k904859-motor-driven-extirpation-instruments-fda-510k.jpg K904859 - MOTOR DRIVEN EXTIRPATION INSTRUMENTS K904859 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Aesculap, Inc.. Cleared Mar 1991. https://www.510kdatabase.net/k905664/ 1991-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k905664-vial-access-cannula-fda-510k.jpg K905664 - VIAL ACCESS CANNULA K905664 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 1991. https://www.510kdatabase.net/k905728/ 1991-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k905728-sonos-500-and-sonos-1000-ultrasound-fda-510k.jpg K905728 - SONOS 500 AND SONOS 1000 ULTRASOUND IMAGING SYSTEM K905728 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Mar 1991. https://www.510kdatabase.net/k910260/ 1991-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k910260-corometrics-mdl-330-fetalmaternal-fda-510k.jpg K910260 - COROMETRICS MDL 330 FETAL/MATERNAL TELEMETRY SYST K910260 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Mar 1991. https://www.510kdatabase.net/k910375/ 1991-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k910375-helical-scan-fda-510k.jpg K910375 - HELICAL SCAN K910375 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Mar 1991. https://www.510kdatabase.net/k903563/ 1991-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k903563-howmedica-hnr-system-fda-510k.jpg K903563 - HOWMEDICA HNR SYSTEM K903563 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Mar 1991. https://www.510kdatabase.net/k910527/ 1991-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k910527-emit-convenience-pack-for-the-cobas-fda-510k.jpg K910527 - EMIT CONVENIENCE PACK FOR THE COBAS MIRA PRIMIDONE K910527 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Mar 1991. https://www.510kdatabase.net/k910690/ 1991-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k910690-3m-model-8240-ite-hearing-aid-fda-510k.jpg K910690 - 3M MODEL 8240 ITE HEARING AID K910690 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: 3M Company. Cleared Mar 1991. https://www.510kdatabase.net/k904329/ 1991-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k904329-clostridium-difficile-toxin-a-enzyme-fda-510k.jpg K904329 - CLOSTRIDIUM DIFFICILE TOXIN A ENZYME IMMUNOASSAY K904329 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 1991. https://www.510kdatabase.net/k905179/ 1991-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k905179-syva-microtrak-chlamlydia-eia-fda-510k.jpg K905179 - SYVA MICROTRAK CHLAMLYDIA EIA, MODIFICATION K905179 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Syva Co.. Cleared Mar 1991. https://www.510kdatabase.net/k905577/ 1991-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k905577-exactech-humeral-shoulder-prosthesis-fda-510k.jpg K905577 - EXACTECH HUMERAL SHOULDER PROSTHESIS K905577 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Mar 1991. https://www.510kdatabase.net/k905580/ 1991-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k905580-total-shoulder-prosthesis-polyethylene-fda-510k.jpg K905580 - TOTAL SHOULDER PROSTHESIS POLYETHYLENE GLENOIND CO K905580 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Mar 1991. https://www.510kdatabase.net/k905607/ 1991-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k905607-kodak-x-omat-multiloader-300-fda-510k.jpg K905607 - KODAK X-OMAT MULTILOADER 300 K905607 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Mar 1991. https://www.510kdatabase.net/k910085/ 1991-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k910085-abuscreen-online-cannabinoids-fda-510k.jpg K910085 - ABUSCREEN ONLINE CANNABINOIDS CALIBRATORS K910085 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Mar 1991. https://www.510kdatabase.net/k910147/ 1991-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k910147-creatinine-reagentcreat-cat-fda-510k.jpg K910147 - CREATININE REAGENT(CREAT), CAT.# RE0015/MODIFIED K910147 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Mar 1991. https://www.510kdatabase.net/k910638/ 1991-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k910638-systemate-triglyceriides-epos-fda-510k.jpg K910638 - SYSTEMATE TRIGLYCERIIDES (EPOS APPLICATION) #65477 K910638 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Mar 1991. https://www.510kdatabase.net/k910689/ 1991-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k910689-abuscreenr-online-controls-fda-510k.jpg K910689 - ABUSCREEN(R) ONLINE CONTROLS K910689 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Mar 1991. https://www.510kdatabase.net/k910756/ 1991-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k910756-abuscreenr-fp-for-methamphetamine-500-fda-510k.jpg K910756 - ABUSCREEN(R) FP FOR METHAMPHETAMINE (500-1000) K910756 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Mar 1991. https://www.510kdatabase.net/k910835/ 1991-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k910835-bactec-nr-860-fda-510k.jpg K910835 - BACTEC NR-860 K910835 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1991. https://www.510kdatabase.net/k910471/ 1991-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k910471-medid-vac-clear-nonconductive-fda-510k.jpg K910471 - MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE K910471 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 1991. https://www.510kdatabase.net/k905739/ 1991-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k905739-zimmer-ceramic-femoral-heads-fda-510k.jpg K905739 - ZIMMER CERAMIC FEMORAL HEADS K905739 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Mar 1991. https://www.510kdatabase.net/k910586/ 1991-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k910586-auto-suturer-polymer-skin-graft-stapler-fda-510k.jpg K910586 - AUTO SUTURE(R) POLYMER SKIN GRAFT STAPLER* K910586 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Mar 1991. https://www.510kdatabase.net/k910052/ 1991-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k910052-milenia-beta-2-microglobulin-fda-510k.jpg K910052 - MILENIA BETA-2 MICROGLOBULIN K910052 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Mar 1991. https://www.510kdatabase.net/k910554/ 1991-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k910554-clinaktm-ise-subsystem-fda-510k.jpg K910554 - CLINAK(TM) ISE SUBSYSTEM K910554 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 1991. https://www.510kdatabase.net/k903526/ 1991-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k903526-altar-pfx-im-rod-fda-510k.jpg K903526 - ALTA(R) PFX IM ROD K903526 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Mar 1991. https://www.510kdatabase.net/k910242/ 1991-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k910242-ef-synergy-quad-modified-fda-510k.jpg K910242 - EF SYNERGY QUAD MODIFIED K910242 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Mar 1991. https://www.510kdatabase.net/k905196/ 1991-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k905196-laparoscope-fda-510k.jpg K905196 - LAPAROSCOPE K905196 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 1991. https://www.510kdatabase.net/k910182/ 1991-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k910182-3m-brand-ear-loop-face-mask-2000f-fda-510k.jpg K910182 - 3M BRAND EAR LOOP FACE MASK, 2000F K910182 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Mar 1991. https://www.510kdatabase.net/k910506/ 1991-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k910506-ofloxacin-5-mcg-sensi-disc-fda-510k.jpg K910506 - OFLOXACIN, 5 MCG SENSI-DISC K910506 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1991. https://www.510kdatabase.net/k902672/ 1991-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k902672-intermedics-430-07-bipol-implant-fda-510k.jpg K902672 - INTERMEDICS 430-07 BIPOL IMPLANT ENDOCARD PAC LEAD K902672 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Mar 1991. https://www.510kdatabase.net/k905423/ 1991-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k905423-cordis-reflex-steerable-guidewire-fda-510k.jpg K905423 - CORDIS REFLEX STEERABLE GUIDEWIRE K905423 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Mar 1991. https://www.510kdatabase.net/k905535/ 1991-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k905535-aloka-ust-952dp-5-endovaginal-transducer-fda-510k.jpg K905535 - ALOKA UST-952DP-5 ENDOVAGINAL TRANSDUCER K905535 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Feb 1991. https://www.510kdatabase.net/k910759/ 1991-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k910759-3m-model-8241-ite-hearing-aid-fda-510k.jpg K910759 - 3M MODEL 8241 ITE HEARING AID K910759 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: 3M Company. Cleared Feb 1991. https://www.510kdatabase.net/k910760/ 1991-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k910760-3m-model-8242-ite-hearing-aid-fda-510k.jpg K910760 - 3M MODEL 8242 ITE HEARING AID K910760 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: 3M Company. Cleared Feb 1991. https://www.510kdatabase.net/k910761/ 1991-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k910761-3m-model-8243-ite-hearing-aid-fda-510k.jpg K910761 - 3M MODEL 8243 ITE HEARING AID K910761 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: 3M Company. Cleared Feb 1991. https://www.510kdatabase.net/k910762/ 1991-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k910762-3m-model-8244-ite-hearing-aid-fda-510k.jpg K910762 - 3M MODEL 8244 ITE HEARING AID K910762 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: 3M Company. Cleared Feb 1991. https://www.510kdatabase.net/k910763/ 1991-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k910763-3m-model-8245-ite-hearing-aid-fda-510k.jpg K910763 - 3M MODEL 8245 ITE HEARING AID K910763 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: 3M Company. Cleared Feb 1991. https://www.510kdatabase.net/k905370/ 1991-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k905370-exactech-bipolar-hip-prosthesis-fda-510k.jpg K905370 - EXACTECH BIPOLAR HIP PROSTHESIS K905370 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Feb 1991. https://www.510kdatabase.net/k905857/ 1991-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k905857-helena-thromboplastin-reagent-fda-510k.jpg K905857 - HELENA THROMBOPLASTIN REAGENT, MODIFICATION K905857 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Feb 1991. https://www.510kdatabase.net/k910133/ 1991-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k910133-chloride-reagent-c1-catalog-no-fda-510k.jpg K910133 - CHLORIDE REAGENT (C1), CATALOG NO. DR0011/MODIFIED K910133 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Feb 1991. https://www.510kdatabase.net/k910222/ 1991-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k910222-cobas-alpha-fda-510k.jpg K910222 - COBAS ALPHA K910222 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Feb 1991. https://www.510kdatabase.net/k903468/ 1991-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k903468-dade-protein-c-clotting-assay-fda-510k.jpg K903468 - DADE PROTEIN C CLOTTING ASSAY K903468 is a FDA 510(k) cleared hematology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Feb 1991. https://www.510kdatabase.net/k905254/ 1991-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k905254-thackray-orthogenesis-identifit-fda-510k.jpg K905254 - THACKRAY ORTHOGENESIS IDENTIFIT FEMORAL HIP PROSTH K905254 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Feb 1991. https://www.510kdatabase.net/k905820/ 1991-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k905820-acar-lactic-dehydrogenase-isoenzyme-fda-510k.jpg K905820 - ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1(LD1) VERI K905820 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Feb 1991. https://www.510kdatabase.net/k910416/ 1991-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k910416-abbott-toxo-m-eia-high-positive-control-fda-510k.jpg K910416 - ABBOTT TOXO-M EIA HIGH POSITIVE CONTROL K910416 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Feb 1991. https://www.510kdatabase.net/k910237/ 1991-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k910237-modified-model-5330-av-demand-pulse-fda-510k.jpg K910237 - MODIFIED MODEL 5330 AV DEMAND PULSE GENERATOR K910237 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Feb 1991. https://www.510kdatabase.net/k900677/ 1991-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k900677-accent-dgtm-balloon-angioplasty-catheter-fda-510k.jpg K900677 - ACCENT DG(TM) BALLOON ANGIOPLASTY CATHETER K900677 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Feb 1991. https://www.510kdatabase.net/k910376/ 1991-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k910376-emit-ii-benzodiazepine-assay-fda-510k.jpg K910376 - EMIT II BENZODIAZEPINE ASSAY K910376 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Feb 1991. https://www.510kdatabase.net/k905433/ 1991-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k905433-codman-disposable-scalp-clip-applier-fda-510k.jpg K905433 - CODMAN DISPOSABLE SCALP CLIP APPLIER K905433 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Feb 1991. https://www.510kdatabase.net/k905163/ 1991-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k905163-nitrate-disk-fda-510k.jpg K905163 - NITRATE DISK K905163 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Feb 1991. https://www.510kdatabase.net/k905476/ 1991-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k905476-stomadent-tm-fda-510k.jpg K905476 - STOMADENT TM K905476 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Feb 1991. https://www.510kdatabase.net/k903771/ 1991-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k903771-hp-model-m1008b-noninvasive-blood-fda-510k.jpg K903771 - HP MODEL M1008B, NONINVASIVE BLOOD PRESSURE MODULE K903771 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Feb 1991. https://www.510kdatabase.net/k905249/ 1991-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k905249-new-usci-7f-ptca-guiding-catheter-fda-510k.jpg K905249 - NEW USCI 7F PTCA GUIDING CATHETER K905249 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Feb 1991. https://www.510kdatabase.net/k905295/ 1991-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k905295-catalog-number-2609-leg-plate-fda-510k.jpg K905295 - CATALOG NUMBER 2609 LEG PLATE K905295 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Feb 1991. https://www.510kdatabase.net/k903690/ 1991-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k903690-medtronic-r-model-3625-screener-fda-510k.jpg K903690 - MEDTRONIC (R) MODEL 3625 SCREENER K903690 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Feb 1991. https://www.510kdatabase.net/k910043/ 1991-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k910043-tenonetm-methamphetamine-fda-510k.jpg K910043 - TENONE(TM) METHAMPHETAMINE K910043 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Feb 1991. https://www.510kdatabase.net/k905477/ 1991-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k905477-olympus-urine-ph-calibrators-levels-i-fda-510k.jpg K905477 - OLYMPUS URINE PH CALIBRATORS LEVELS I AND II K905477 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Feb 1991. https://www.510kdatabase.net/k905707/ 1991-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k905707-baxter-laparoscopic-cholangiography-fda-510k.jpg K905707 - BAXTER LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERS K905707 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Feb 1991. https://www.510kdatabase.net/k910044/ 1991-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k910044-milenia-cocaine-metabolite-fda-510k.jpg K910044 - MILENIA COCAINE METABOLITE K910044 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Feb 1991. https://www.510kdatabase.net/k910061/ 1991-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k910061-k-module-ii-heat-therapy-system-fda-510k.jpg K910061 - K-MODULE II HEAT THERAPY SYSTEM K910061 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Baxter Healthcare Corp. Cleared Feb 1991. https://www.510kdatabase.net/k910249/ 1991-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k910249-stratus-estradiol-fluoremetric-enzyme-fda-510k.jpg K910249 - STRATUS ESTRADIOL FLUOREMETRIC ENZYME K910249 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Baxter Healthcare Corp. Cleared Feb 1991. https://www.510kdatabase.net/k905252/ 1991-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k905252-aloka-680-diagnostic-ultrasound-fda-510k.jpg K905252 - ALOKA 680 DIAGNOSTIC ULTRASOUND SCANNING SYSTEM K905252 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Feb 1991. https://www.510kdatabase.net/k905366/ 1991-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k905366-magnetom-spas-actively-shielded-fda-510k.jpg K905366 - MAGNETOM SP/AS (ACTIVELY SHIELDED) K905366 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 1991. https://www.510kdatabase.net/k905369/ 1991-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k905369-ust-2266u-5-cw-doppler-transducer-fda-510k.jpg K905369 - UST-2266U-5 CW DOPPLER TRANSDUCER K905369 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Feb 1991. https://www.510kdatabase.net/k905396/ 1991-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k905396-hemastix-reagent-strips-fda-510k.jpg K905396 - HEMASTIX REAGENT STRIPS K905396 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Feb 1991. https://www.510kdatabase.net/k905426/ 1991-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k905426-auto-suture-modified-endo-stream-fda-510k.jpg K905426 - AUTO SUTURE MODIFIED ENDO STREAM SUC./IRRI. DEVICE K905426 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Feb 1991. https://www.510kdatabase.net/k905673/ 1991-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k905673-ab-trol-ii-coagulation-control-plasm-fda-510k.jpg K905673 - AB-TROL II COAGULATION CONTROL PLASM CAT. NO. 5183 K905673 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Feb 1991. https://www.510kdatabase.net/k910192/ 1991-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k910192-auto-suture-endoscopic-ta-surgical-fda-510k.jpg K910192 - AUTO SUTURE ENDOSCOPIC TA SURGICAL STAPLER K910192 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Feb 1991. https://www.510kdatabase.net/k910199/ 1991-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k910199-medtronic-model-3487a-pisces-quad-lead-fda-510k.jpg K910199 - MEDTRONIC MODEL 3487A PISCES-QUAD LEAD K910199 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Feb 1991. https://www.510kdatabase.net/k904027/ 1991-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k904027-abbott-visiontm-glycated-hb-fda-510k.jpg K904027 - ABBOTT VISION(TM) GLYCATED HB K904027 is a FDA 510(k) cleared hematology medical device. Manufacturer: Abbott Laboratories. Cleared Feb 1991. https://www.510kdatabase.net/k904079/ 1991-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k904079-bard-uterine-manipulator-fda-510k.jpg K904079 - BARD UTERINE MANIPULATOR K904079 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Feb 1991. https://www.510kdatabase.net/k904696/ 1991-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k904696-wep-8430a-telemetry-central-station-fda-510k.jpg K904696 - WEP-8430A TELEMETRY CENTRAL STATION K904696 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Feb 1991. https://www.510kdatabase.net/k905458/ 1991-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k905458-swan-ganzr-flow-direct-oximetrythermod-fda-510k.jpg K905458 - SWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHER K905458 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Feb 1991. https://www.510kdatabase.net/k905143/ 1991-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k905143-skin-marker-fda-510k.jpg K905143 - SKIN MARKER K905143 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Aesculap, Inc.. Cleared Feb 1991. https://www.510kdatabase.net/k905861/ 1991-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k905861-acar-lactic-dehydrogenase-isoenzyme-1-fda-510k.jpg K905861 - ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1 (LD1) METH K905861 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Feb 1991. https://www.510kdatabase.net/k904990/ 1991-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k904990-emit-convenience-pack-quinidine-fda-510k.jpg K904990 - EMIT CONVENIENCE PACK, QUINIDINE ASSAY/CALIBRATORS K904990 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Feb 1991. https://www.510kdatabase.net/k905828/ 1991-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k905828-abuscreenr-online-calibrators-fda-510k.jpg K905828 - ABUSCREEN(R) ONLINE CALIBRATORS K905828 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Feb 1991. https://www.510kdatabase.net/k910087/ 1991-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k910087-abuscreen-online-opiates-calibrators-fda-510k.jpg K910087 - ABUSCREEN ONLINE OPIATES CALIBRATORS K910087 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Feb 1991. https://www.510kdatabase.net/k910143/ 1991-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k910143-kodak-extachem-clinical-chemistry-fda-510k.jpg K910143 - KODAK EXTACHEM CLINICAL CHEMISTRY SLIDES (FE) K910143 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Feb 1991. https://www.510kdatabase.net/k902999/ 1991-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k902999-vascular-retrieval-forceps-fda-510k.jpg K902999 - VASCULAR RETRIEVAL FORCEPS K902999 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Feb 1991. https://www.510kdatabase.net/k904575/ 1991-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k904575-model-5866-37m-lead-adaptor-kit-fda-510k.jpg K904575 - MODEL 5866-37M LEAD ADAPTOR KIT K904575 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Feb 1991. https://www.510kdatabase.net/k905297/ 1991-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k905297-diaventional-catheter-fda-510k.jpg K905297 - DIAVENTIONAL CATHETER K905297 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Feb 1991. https://www.510kdatabase.net/k905407/ 1991-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k905407-model-3487a-pisces-quad3587a-fda-510k.jpg K905407 - MODEL 3487A PISCES-QUAD,3587A RESUME,3586 RESUME K905407 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Feb 1991. https://www.510kdatabase.net/k905615/ 1991-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k905615-magnetic-resonance-diag-dev-special-fda-510k.jpg K905615 - MAGNETIC RESONANCE DIAG. DEV. SPECIAL PURPOSE COIL K905615 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 1991. https://www.510kdatabase.net/k905727/ 1991-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k905727-usci-satin-finish-soft-tip-fda-510k.jpg K905727 - USCI SATIN FINISH SOFT TIP ANGIOGRAPHIC CATHETER K905727 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Feb 1991. https://www.510kdatabase.net/k902623/ 1991-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k902623-flexiflo-stomate-extension-tube-fda-510k.jpg K902623 - FLEXIFLO STOMATE EXTENSION TUBE K902623 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Abbott Laboratories. Cleared Jan 1991. https://www.510kdatabase.net/k905106/ 1991-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k905106-auto-suturer-ta-premiumtm-urology-fda-510k.jpg K905106 - AUTO SUTURE(R) TA PREMIUM(TM) UROLOGY STAPLER K905106 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Jan 1991. https://www.510kdatabase.net/k905391/ 1991-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k905391-ust-969-5-convex-transducer-fda-510k.jpg K905391 - UST-969-5 CONVEX TRANSDUCER K905391 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Jan 1991. https://www.510kdatabase.net/k905440/ 1991-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k905440-fine-size-nonabsorbable-dacron-fda-510k.jpg K905440 - FINE SIZE NONABSORBABLE DACRON SURGICAL SUTURE K905440 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Jan 1991. https://www.510kdatabase.net/k905661/ 1991-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k905661-systemate-total-protein-epos-fda-510k.jpg K905661 - SYSTEMATE TOTAL PROTEIN (EPOS APPLICATION) #65420 K905661 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jan 1991. https://www.510kdatabase.net/k904409/ 1991-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k904409-medtronicr-model-3470-x-treltm-receiver-fda-510k.jpg K904409 - MEDTRONIC(R) MODEL 3470 X-TREL(TM) RECEIVER K904409 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Jan 1991. https://www.510kdatabase.net/k905189/ 1991-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k905189-baxter-angioscopy-pump-tubing-set-fda-510k.jpg K905189 - BAXTER ANGIOSCOPY PUMP TUBING SET (MODEL NL) K905189 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jan 1991. https://www.510kdatabase.net/k905432/ 1991-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k905432-datascope-interlock-guide-wire-extension-fda-510k.jpg K905432 - DATASCOPE INTERLOCK GUIDE WIRE EXTENSION K905432 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Jan 1991. https://www.510kdatabase.net/k905540/ 1991-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k905540-respironics-bipap-remote-control-unit-fda-510k.jpg K905540 - RESPIRONICS BIPAP REMOTE CONTROL UNIT K905540 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Jan 1991. https://www.510kdatabase.net/k910075/ 1991-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k910075-specific-allergen-modules-for-alastat-fda-510k.jpg K910075 - SPECIFIC ALLERGEN MODULES FOR ALASTAT ALLERGEN IGE K910075 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jan 1991. https://www.510kdatabase.net/k904931/ 1991-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k904931-auto-suturer-permanent-purstringtm-fda-510k.jpg K904931 - AUTO SUTURE(R) PERMANENT PURSTRING(TM) APPLIER* K904931 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Jan 1991. https://www.510kdatabase.net/k905761/ 1991-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k905761-type-iii-dental-gold-alloy-for-crown-fda-510k.jpg K905761 - TYPE III DENTAL GOLD ALLOY FOR CROWN & BRIDGE APP. K905761 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jan 1991. https://www.510kdatabase.net/k905811/ 1991-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k905811-argenco-52hn-fda-510k.jpg K905811 - ARGENCO 52HN K905811 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jan 1991. https://www.510kdatabase.net/k903854/ 1991-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k903854-rapitexr-asl-new-fda-510k.jpg K903854 - RAPITEX(R) ASL NEW K903854 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Jan 1991. https://www.510kdatabase.net/k905275/ 1991-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k905275-osteonicsr-mpss-hip-stem-series-fda-510k.jpg K905275 - OSTEONICS(R) MPSS HIP STEM SERIES K905275 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Jan 1991. https://www.510kdatabase.net/k905503/ 1991-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k905503-tru-touch-powder-free-fda-510k.jpg K905503 - TRU-TOUCH POWDER FREE K905503 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jan 1991. https://www.510kdatabase.net/k905151/ 1991-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k905151-vancomycin-disk-5-mcg-fda-510k.jpg K905151 - VANCOMYCIN DISK-5 MCG K905151 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Jan 1991. https://www.510kdatabase.net/k905660/ 1991-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k905660-systemate-albumin-epos-application-65401-fda-510k.jpg K905660 - SYSTEMATE ALBUMIN (EPOS APPLICATION) #65401 K905660 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jan 1991. https://www.510kdatabase.net/k904907/ 1991-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k904907-endopath-disposable-surgical-trocar-fda-510k.jpg K904907 - ENDOPATH DISPOSABLE SURGICAL TROCAR REDUCER K904907 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ethicon, Inc.. Cleared Jan 1991. https://www.510kdatabase.net/k905259/ 1991-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k905259-vista-hpq-system-fda-510k.jpg K905259 - VISTA HPQ SYSTEM K905259 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Jan 1991. https://www.510kdatabase.net/k903529/ 1991-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k903529-bml-series-fda-510k.jpg K903529 - BML SERIES K903529 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Corp.. Cleared Jan 1991. https://www.510kdatabase.net/k903842/ 1991-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k903842-st-e1-overtube-fda-510k.jpg K903842 - ST-E1 OVERTUBE K903842 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Corp.. Cleared Jan 1991. https://www.510kdatabase.net/k905261/ 1991-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k905261-imx-free-triiodothyronine-fda-510k.jpg K905261 - IMX FREE TRIIODOTHYRONINE K905261 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jan 1991. https://www.510kdatabase.net/k903877/ 1991-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k903877-mts-femoral-hip-system-fda-510k.jpg K903877 - MTS FEMORAL HIP SYSTEM K903877 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 3M Company. Cleared Jan 1991. https://www.510kdatabase.net/k904247/ 1991-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k904247-free-protein-s-reagent-cat-no-5363-fda-510k.jpg K904247 - FREE PROTEIN S REAGENT CAT. NO. 5363 K904247 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Jan 1991. https://www.510kdatabase.net/k904589/ 1991-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k904589-kodak-surecelltm-strep-a-control-fluid-fda-510k.jpg K904589 - KODAK SURECELL(TM) STREP A CONTROL FLUID SET K904589 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Eastman Kodak Company. Cleared Jan 1991. https://www.510kdatabase.net/k904779/ 1991-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k904779-button-replacement-gastrostomy-device-fda-510k.jpg K904779 - BUTTON REPLACEMENT GASTROSTOMY DEVICE K904779 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 1991. https://www.510kdatabase.net/k904816/ 1991-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k904816-thyroxine-monoclonal-antibody-solid-fda-510k.jpg K904816 - THYROXINE MONOCLONAL ANTIBODY SOLID PHASE RADIOIMM K904816 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jan 1991. https://www.510kdatabase.net/k905379/ 1991-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k905379-auto-suture-modified-surgitie-endo-fda-510k.jpg K905379 - AUTO SUTURE MODIFIED SURGITIE ENDO. LIGATING LOOP K905379 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Jan 1991. https://www.510kdatabase.net/k910086/ 1991-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k910086-abuscreen-online-cocaine-metabolite-fda-510k.jpg K910086 - ABUSCREEN ONLINE COCAINE METABOLITE CALIBRATORS K910086 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jan 1991. https://www.510kdatabase.net/k902674/ 1991-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k902674-datascope-arterial-cannula-waccess-port-fda-510k.jpg K902674 - DATASCOPE ARTERIAL CANNULA W/ACCESS PORT K902674 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Jan 1991. https://www.510kdatabase.net/k904282/ 1991-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k904282-bifurcated-gore-tex-stretch-vascular-fda-510k.jpg K904282 - BIFURCATED GORE TEX STRETCH VASCULAR GRAFT K904282 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Jan 1991. https://www.510kdatabase.net/k905587/ 1991-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k905587-auto-suturer-endoscopic-ldstm-ligating-fda-510k.jpg K905587 - AUTO SUTURE(R) ENDOSCOPIC LDS(TM) LIGATING DEVICE K905587 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Jan 1991. https://www.510kdatabase.net/k904777/ 1991-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k904777-series-51-and-53-disposable-pressure-fda-510k.jpg K904777 - SERIES 51 AND 53 DISPOSABLE PRESSURE TRANSDUCERS K904777 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jan 1991. https://www.510kdatabase.net/k905100/ 1991-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k905100-hewlett-packard-model-5650c-cardio-fda-510k.jpg K905100 - HEWLETT PACKARD MODEL 5650C, CARDIO DATA MGMT SYST K905100 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Jan 1991. https://www.510kdatabase.net/k905659/ 1991-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k905659-systemate-calcium-epos-application-65409-fda-510k.jpg K905659 - SYSTEMATE CALCIUM (EPOS APPLICATION) #65409 K905659 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jan 1991. https://www.510kdatabase.net/k905730/ 1991-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k905730-abuscreen-ontrak-for-cocaine-200ngml-fda-510k.jpg K905730 - ABUSCREEN ONTRAK FOR COCAINE (200NG/ML) K905730 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jan 1991. https://www.510kdatabase.net/k901548/ 1991-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k901548-biomedical-sensors-shiley-bgm-4000-fda-510k.jpg K901548 - BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS K901548 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shiley, Inc.. Cleared Jan 1991. https://www.510kdatabase.net/k904971/ 1991-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k904971-ct-hilight-advantage-ii-fda-510k.jpg K904971 - CT HILIGHT ADVANTAGE II K904971 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Jan 1991. https://www.510kdatabase.net/k902365/ 1991-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k902365-modular-unipolar-system-fda-510k.jpg K902365 - MODULAR UNIPOLAR SYSTEM K902365 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jan 1991. https://www.510kdatabase.net/k904996/ 1991-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k904996-abuscreen-online-tm-for-thc-fda-510k.jpg K904996 - ABUSCREEN ONLINE TM FOR THC K904996 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jan 1991. https://www.510kdatabase.net/k905856/ 1991-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k905856-model-556-monitor-fda-510k.jpg K905856 - MODEL 556 MONITOR K905856 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Jan 1991. https://www.510kdatabase.net/k904174/ 1991-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k904174-starcam-4000-fda-510k.jpg K904174 - STARCAM 4000 K904174 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jan 1991. https://www.510kdatabase.net/k905158/ 1991-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k905158-osteonicsr-6011-hip-stem-series-fda-510k.jpg K905158 - OSTEONICS(R) 6011 HIP STEM SERIES K905158 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Jan 1991. https://www.510kdatabase.net/k905406/ 1991-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k905406-osteonics-hip-revision-wedges-fda-510k.jpg K905406 - OSTEONICS HIP REVISION WEDGES K905406 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Jan 1991. https://www.510kdatabase.net/k905662/ 1991-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k905662-systemate-ggt-epos-application-65414-fda-510k.jpg K905662 - SYSTEMATE GGT (EPOS APPLICATION) #65414 K905662 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jan 1991. https://www.510kdatabase.net/k904602/ 1991-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k904602-medtronic-model-5301b-test-cable-fda-510k.jpg K904602 - MEDTRONIC MODEL 5301B TEST CABLE K904602 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jan 1991. https://www.510kdatabase.net/k905149/ 1991-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k905149-titan-gel-fda-510k.jpg K905149 - TITAN GEL K905149 is a FDA 510(k) cleared immunology medical device. Manufacturer: Helena Laboratories. Cleared Jan 1991. https://www.510kdatabase.net/k905566/ 1991-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k905566-kodak-ektascan-multi-format-imager-fda-510k.jpg K905566 - KODAK EKTASCAN MULTI-FORMAT IMAGER VARIOUS MODELS K905566 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Jan 1991. https://www.510kdatabase.net/k905070/ 1991-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k905070-vistar-fda-510k.jpg K905070 - VISTAR K905070 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Jan 1991. https://www.510kdatabase.net/k904795/ 1990-12-31 monthly 0.5 https://www.510kdatabase.net/og-image/k904795-facsprep-robotic-sample-preparation-fda-510k.jpg K904795 - FACSPREP ROBOTIC SAMPLE PREPARATION SYSTEM K904795 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Dec 1990. https://www.510kdatabase.net/k905655/ 1990-12-31 monthly 0.5 https://www.510kdatabase.net/og-image/k905655-nonabsorbable-polypropylene-surgical-fda-510k.jpg K905655 - NONABSORBABLE POLYPROPYLENE SURGICAL MESH K905655 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Dec 1990. https://www.510kdatabase.net/k903844/ 1990-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k903844-omnishunt-system-for-ventricular-fda-510k.jpg K903844 - OMNISHUNT SYSTEM FOR VENTRICULAR SHUNTING K903844 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cordis Corp.. Cleared Dec 1990. https://www.510kdatabase.net/k904403/ 1990-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k904403-bard-ambulatory-pca-drug-delivery-system-fda-510k.jpg K904403 - BARD AMBULATORY PCA DRUG DELIVERY SYSTEM K904403 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 1990. https://www.510kdatabase.net/k905483/ 1990-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k905483-memorymate-model-8270-ite-hearing-aid-fda-510k.jpg K905483 - MEMORYMATE MODEL 8270 ITE HEARING AID K905483 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: 3M Company. Cleared Dec 1990. https://www.510kdatabase.net/k904997/ 1990-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k904997-abuscreen-online-tm-for-opiates-fda-510k.jpg K904997 - ABUSCREEN ONLINE TM FOR OPIATES K904997 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Dec 1990. https://www.510kdatabase.net/k905147/ 1990-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k905147-adultsteriledisposnonivasblood-press-fda-510k.jpg K905147 - ADULT,STERILE,DISPOS.,NONIVAS.,BLOOD PRESS. CUFFS K905147 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Dec 1990. https://www.510kdatabase.net/k905592/ 1990-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k905592-affinity-fsh-test-system-fda-510k.jpg K905592 - AFFINITY FSH TEST SYSTEM K905592 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Dec 1990. https://www.510kdatabase.net/k904081/ 1990-12-26 monthly 0.5 https://www.510kdatabase.net/og-image/k904081-glucometer-qa-blood-glucose-meter-and-fda-510k.jpg K904081 - GLUCOMETER QA BLOOD GLUCOSE METER AND GLUCOFILM K904081 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Dec 1990. https://www.510kdatabase.net/k904568/ 1990-12-26 monthly 0.5 https://www.510kdatabase.net/og-image/k904568-emitr-ii-cannabinoid-100-ng-assay-fda-510k.jpg K904568 - EMIT(R) II CANNABINOID 100 NG ASSAY K904568 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Dec 1990. https://www.510kdatabase.net/k904569/ 1990-12-26 monthly 0.5 https://www.510kdatabase.net/og-image/k904569-emitr-ii-9-cannabinoid-negative-fda-510k.jpg K904569 - EMIT(R) II 9 CANNABINOID NEGATIVE CALIBRA/CONTROLS K904569 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Dec 1990. https://www.510kdatabase.net/k904570/ 1990-12-26 monthly 0.5 https://www.510kdatabase.net/og-image/k904570-emitr-ii-cannabinoid-20-ng-assay-fda-510k.jpg K904570 - EMIT(R) II CANNABINOID 20 NG ASSAY K904570 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Dec 1990. https://www.510kdatabase.net/k904571/ 1990-12-26 monthly 0.5 https://www.510kdatabase.net/og-image/k904571-emitr-ii-cannabinoid-50-ng-assay-fda-510k.jpg K904571 - EMIT(R) II CANNABINOID 50 NG ASSAY K904571 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Dec 1990. https://www.510kdatabase.net/k904588/ 1990-12-24 monthly 0.5 https://www.510kdatabase.net/og-image/k904588-auto-suturer-modified-endoscopic-fda-510k.jpg K904588 - AUTO SUTURE(R) MODIFIED ENDOSCOPIC LIGATING LOOP K904588 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Dec 1990. https://www.510kdatabase.net/k904553/ 1990-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k904553-bone-staples-fda-510k.jpg K904553 - BONE STAPLE(S) K904553 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Dec 1990. https://www.510kdatabase.net/k896047/ 1990-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k896047-the-omnifit-epf-hip-joint-femoral-stem-fda-510k.jpg K896047 - THE OMNIFIT EPF HIP JOINT FEMORAL STEM K896047 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Dec 1990. https://www.510kdatabase.net/k904892/ 1990-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k904892-vacuum-bake-cycle-fda-510k.jpg K904892 - VACUUM BAKE CYCLE K904892 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Dec 1990. https://www.510kdatabase.net/k905101/ 1990-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k905101-neonatalsteriledisposnoninvas-blood-fda-510k.jpg K905101 - NEONATAL/STERILE/DISPOS/NONINVAS BLOOD PRESS CUFF K905101 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Dec 1990. https://www.510kdatabase.net/k904022/ 1990-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k904022-nitro-blue-tetrazolium-reduction-fda-510k.jpg K904022 - NITRO BLUE TETRAZOLIUM REDUCTION K904022 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Dec 1990. https://www.510kdatabase.net/k902404/ 1990-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k902404-sarns-delphin-centrifugal-system-fda-510k.jpg K902404 - SARNS DELPHIN CENTRIFUGAL SYSTEM W/DIRECTION. FLOW K902404 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: 3M Company. Cleared Dec 1990. https://www.510kdatabase.net/k903632/ 1990-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k903632-intersept-1375-venous-reservoir-fda-510k.jpg K903632 - INTERSEPT 1375 VENOUS RESERVOIR K903632 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Dec 1990. https://www.510kdatabase.net/k903971/ 1990-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k903971-argenco-26b-fda-510k.jpg K903971 - ARGENCO 26B K903971 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Dec 1990. https://www.510kdatabase.net/k904020/ 1990-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k904020-memorymate-hearing-aid-with-pmc-fda-510k.jpg K904020 - MEMORYMATE HEARING AID WITH PMC PROGRAMMER K904020 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: 3M Company. Cleared Dec 1990. https://www.510kdatabase.net/k904390/ 1990-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k904390-anti-human-leu-2a-cd8-pe-fda-510k.jpg K904390 - ANTI-HUMAN LEU-2A (CD8) PE K904390 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Dec 1990. https://www.510kdatabase.net/k904788/ 1990-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k904788-mewissen-catheter-fda-510k.jpg K904788 - MEWISSEN CATHETER K904788 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Dec 1990. https://www.510kdatabase.net/k904944/ 1990-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k904944-transluminal-endarterectomy-device-fda-510k.jpg K904944 - TRANSLUMINAL ENDARTERECTOMY DEVICE K904944 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Dec 1990. https://www.510kdatabase.net/k895713/ 1990-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k895713-3m-igg-fastlymetm-test-fda-510k.jpg K895713 - 3M IGG FASTLYME(TM) TEST K895713 is a FDA 510(k) cleared microbiology medical device. Manufacturer: 3M Company. Cleared Dec 1990. https://www.510kdatabase.net/k903995/ 1990-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k903995-naphthol-as-d-chlora-naphthyl-acet-fda-510k.jpg K903995 - NAPHTHOL AS-D CHLOR/A-NAPHTHYL ACET ESTERASE KIT K903995 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Dec 1990. https://www.510kdatabase.net/k904167/ 1990-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k904167-pathodx-herpes-typing-fda-510k.jpg K904167 - PATHODX HERPES TYPING K904167 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Dec 1990. https://www.510kdatabase.net/k904758/ 1990-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k904758-cardiofax-ecg-8830a-fda-510k.jpg K904758 - CARDIOFAX ECG-8830A K904758 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Dec 1990. https://www.510kdatabase.net/k904856/ 1990-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k904856-abuscreen-ontrak-for-thc-fda-510k.jpg K904856 - ABUSCREEN ONTRAK FOR THC K904856 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Dec 1990. https://www.510kdatabase.net/k905202/ 1990-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k905202-turbiquant-myoglobin-fda-510k.jpg K905202 - TURBIQUANT MYOGLOBIN K905202 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Dec 1990. https://www.510kdatabase.net/k905380/ 1990-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k905380-1-cut-acl-graft-knife-fda-510k.jpg K905380 - 1-CUT ACL GRAFT KNIFE K905380 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Depuy, Inc.. Cleared Dec 1990. https://www.510kdatabase.net/k904667/ 1990-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k904667-na-needles-fda-510k.jpg K904667 - NA NEEDLES K904667 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Olympus Corp.. Cleared Dec 1990. https://www.510kdatabase.net/k904209/ 1990-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k904209-simultest-t-b-cell-testanti-leu-4-fitc-fda-510k.jpg K904209 - SIMULTEST T & B CELL TEST,ANTI-LEU-4 FITC & 12 PE K904209 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Dec 1990. https://www.510kdatabase.net/k904173/ 1990-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k904173-insulated-electrodes-and-laparoscopic-fda-510k.jpg K904173 - INSULATED ELECTRODES AND LAPAROSCOPIC PROBICS K904173 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Dec 1990. https://www.510kdatabase.net/k904476/ 1990-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k904476-vessel-dilator-fda-510k.jpg K904476 - VESSEL DILATOR K904476 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Dec 1990. https://www.510kdatabase.net/k905228/ 1990-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k905228-model-ca150-cellulose-acetate-hollow-fda-510k.jpg K905228 - MODEL CA.150 CELLULOSE ACETATE HOLLOW FIBER DIALYZ K905228 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Dec 1990. https://www.510kdatabase.net/k903931/ 1990-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k903931-gore-texr-stretch-vascular-graft-fda-510k.jpg K903931 - GORE-TEX(R) STRETCH VASCULAR GRAFT K903931 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Dec 1990. https://www.510kdatabase.net/k904040/ 1990-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k904040-softshell-venous-reservoir-fda-510k.jpg K904040 - SOFTSHELL VENOUS RESERVOIR K904040 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 1990. https://www.510kdatabase.net/k904143/ 1990-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k904143-v-mueller-trocarstrocar-sleeves-needles-fda-510k.jpg K904143 - V. MUELLER TROCARS/TROCAR SLEEVES & NEEDLES K904143 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Dec 1990. https://www.510kdatabase.net/k904477/ 1990-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k904477-guidewire-fda-510k.jpg K904477 - GUIDEWIRE K904477 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Dec 1990. https://www.510kdatabase.net/k904968/ 1990-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k904968-qclyte-protein-based-ise-control-fda-510k.jpg K904968 - QCLYTE PROTEIN BASED ISE CONTROL K904968 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Baxter Healthcare Corp. Cleared Dec 1990. https://www.510kdatabase.net/k904050/ 1990-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k904050-model-dh-1000-single-detecdual-detec-fda-510k.jpg K904050 - MODEL DH-1000 SINGLE DETEC./DUAL DETEC NUCL CAMERA K904050 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Dec 1990. https://www.510kdatabase.net/k904104/ 1990-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k904104-endopath-unshielded-disposable-fda-510k.jpg K904104 - ENDOPATH UNSHIELDED DISPOSABLE SURGICAL TROCAR K904104 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ethicon, Inc.. Cleared Dec 1990. https://www.510kdatabase.net/k904142/ 1990-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k904142-grasping-forcepsaligator-forcepsneedle-fda-510k.jpg K904142 - GRASPING FORCEPS/ALIGATOR FORCEPS/NEEDLE HOLDERS K904142 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Dec 1990. https://www.510kdatabase.net/k904844/ 1990-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k904844-precision-hip-stem-with-additional-fda-510k.jpg K904844 - PRECISION HIP STEM WITH ADDITIONAL STEM SIZES K904844 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Dec 1990. https://www.510kdatabase.net/k904919/ 1990-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k904919-proximal-femur-replacement-stem-fda-510k.jpg K904919 - PROXIMAL FEMUR REPLACEMENT STEM K904919 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Dec 1990. https://www.510kdatabase.net/k902612/ 1990-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k902612-cordis-cinchtm-steer-guidewire-exten-fda-510k.jpg K902612 - CORDIS CINCH(TM) STEER GUIDEWIRE EXTEN W/SLX COAT K902612 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Dec 1990. https://www.510kdatabase.net/k904394/ 1990-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k904394-inflationdeflation-device-fda-510k.jpg K904394 - INFLATION/DEFLATION DEVICE K904394 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Dec 1990. https://www.510kdatabase.net/k900001/ 1990-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k900001-corometrics-model-556-neonatal-monitor-fda-510k.jpg K900001 - COROMETRICS MODEL 556 NEONATAL MONITOR K900001 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Nov 1990. https://www.510kdatabase.net/k901536/ 1990-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k901536-sterile-view-disp-hoodgown-uv-barrier-fda-510k.jpg K901536 - STERILE VIEW DISP. HOOD/GOWN UV, BARRIER HOOD, UV K901536 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Depuy, Inc.. Cleared Nov 1990. https://www.510kdatabase.net/k904043/ 1990-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k904043-kxo-80c80d-fda-510k.jpg K904043 - KXO-80C/80D K904043 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Nov 1990. https://www.510kdatabase.net/k904044/ 1990-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k904044-tf-63sa-fda-510k.jpg K904044 - TF-63SA K904044 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Nov 1990. https://www.510kdatabase.net/k904683/ 1990-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k904683-stratus-primidone-fluorometric-enzyme-fda-510k.jpg K904683 - STRATUS PRIMIDONE FLUOROMETRIC ENZYME K904683 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Baxter Healthcare Corp. Cleared Nov 1990. https://www.510kdatabase.net/k904765/ 1990-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k904765-emit-r-ii-phencyclidine-assay-fda-510k.jpg K904765 - EMIT (R) II PHENCYCLIDINE ASSAY K904765 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Nov 1990. https://www.510kdatabase.net/k904995/ 1990-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k904995-abuscreen-online-tm-for-cocaine-fda-510k.jpg K904995 - ABUSCREEN ONLINE TM FOR COCAINE METABOLITE K904995 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Nov 1990. https://www.510kdatabase.net/k903579/ 1990-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k903579-flexiflo-stomate-decompression-tube-fda-510k.jpg K903579 - FLEXIFLO STOMATE DECOMPRESSION TUBE K903579 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1990. https://www.510kdatabase.net/k904111/ 1990-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k904111-htr-polymer-htr-mx-fda-510k.jpg K904111 - HTR POLYMER, HTR-MX K904111 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Nov 1990. https://www.510kdatabase.net/k903343/ 1990-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k903343-syringe-infusion-pump-fda-510k.jpg K903343 - SYRINGE INFUSION PUMP K903343 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Nov 1990. https://www.510kdatabase.net/k903923/ 1990-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k903923-uscir-silk-tm-guide-wire-fda-510k.jpg K903923 - USCI(R) SILK (TM) GUIDE WIRE K903923 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 1990. https://www.510kdatabase.net/k904352/ 1990-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k904352-codman-collins-radioparent-sternal-fda-510k.jpg K904352 - CODMAN COLLINS RADIOPARENT STERNAL BLADES K904352 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Nov 1990. https://www.510kdatabase.net/k904451/ 1990-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k904451-milenia-tm-methamphetamine-fda-510k.jpg K904451 - MILENIA (TM) METHAMPHETAMINE K904451 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Nov 1990. https://www.510kdatabase.net/k904734/ 1990-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k904734-pharmaseal-disposable-abdominal-trocar-fda-510k.jpg K904734 - PHARMASEAL DISPOSABLE ABDOMINAL TROCAR K904734 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Nov 1990. https://www.510kdatabase.net/k902526/ 1990-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k902526-capd-disposable-disconnect-y-set-code-fda-510k.jpg K902526 - CAPD DISPOSABLE DISCONNECT Y-SET CODE: 5C4481 K902526 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Nov 1990. https://www.510kdatabase.net/k904541/ 1990-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k904541-labeling-submittal-adx-tm-cannabinoids-fda-510k.jpg K904541 - LABELING SUBMITTAL, ADX TM CANNABINOIDS-GS K904541 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1990. https://www.510kdatabase.net/k904761/ 1990-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k904761-pn-35310-il-test-alkaline-phosphatase-fda-510k.jpg K904761 - P/N 35310, IL TEST ALKALINE PHOSPHATASE REAGENT K904761 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Nov 1990. https://www.510kdatabase.net/k904764/ 1990-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k904764-emit-r-ii-calibrator-a-level-1-cutoff-fda-510k.jpg K904764 - EMIT (R) II CALIBRATOR A LEVEL 1 (CUTOFF) 2 (HIGH) K904764 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Nov 1990. https://www.510kdatabase.net/k902428/ 1990-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k902428-integrated-diagnostic-system-waddl-fda-510k.jpg K902428 - INTEGRATED DIAGNOSTIC SYSTEM W/ADD'L OPTIONS K902428 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Nov 1990. https://www.510kdatabase.net/k903325/ 1990-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k903325-flexiflo-r-versa-peg-tm-gastrostomy-kit-fda-510k.jpg K903325 - FLEXIFLO (R) VERSA-PEG (TM) GASTROSTOMY KIT K903325 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1990. https://www.510kdatabase.net/k903930/ 1990-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k903930-datascope-percor-stat-dl-105-fr-50cc-fda-510k.jpg K903930 - DATASCOPE PERCOR STAT DL 10.5 FR 50CC K903930 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Nov 1990. https://www.510kdatabase.net/k904478/ 1990-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k904478-nonabsorbable-silk-surgical-suture-fda-510k.jpg K904478 - NONABSORBABLE SILK SURGICAL SUTURE K904478 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Nov 1990. https://www.510kdatabase.net/k904891/ 1990-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k904891-nonabsorbable-silk-surgical-suture-fda-510k.jpg K904891 - NONABSORBABLE SILK SURGICAL SUTURE (SECOND SOURCE) K904891 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Nov 1990. https://www.510kdatabase.net/k901337/ 1990-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k901337-hilal-embolization-microcoiltm-fda-510k.jpg K901337 - HILAL EMBOLIZATION MICROCOIL(TM) K901337 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cook, Inc.. Cleared Nov 1990. https://www.510kdatabase.net/k903589/ 1990-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k903589-ef-synergy-quad-fda-510k.jpg K903589 - EF SYNERGY QUAD K903589 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Nov 1990. https://www.510kdatabase.net/k904590/ 1990-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k904590-kodak-ektascan-laser-printer-model-100-fda-510k.jpg K904590 - KODAK EKTASCAN LASER PRINTER, MODEL 100 XLP K904590 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Nov 1990. https://www.510kdatabase.net/k904035/ 1990-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k904035-rep-ultra-hdlvldlldl-cholesterol-system-fda-510k.jpg K904035 - REP ULTRA HDL,VLDL/LDL CHOLESTEROL SYSTEM K904035 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Nov 1990. https://www.510kdatabase.net/k904301/ 1990-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k904301-du-pont-dimensionr-salicylatesal-method-fda-510k.jpg K904301 - DU PONT DIMENSION(R) SALICYLATE(SAL) METHOD K904301 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Nov 1990. https://www.510kdatabase.net/k904768/ 1990-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k904768-kodatrol-i-and-ii-control-and-diluent-fda-510k.jpg K904768 - KODATROL I AND II CONTROL AND DILUENT SET K904768 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Nov 1990. https://www.510kdatabase.net/k901659/ 1990-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k901659-titanium-greenfieldr-vena-cava-filter-fda-510k.jpg K901659 - TITANIUM GREENFIELD(R) VENA CAVA FILTER W/HOOKS K901659 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Nov 1990. https://www.510kdatabase.net/k904341/ 1990-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k904341-aptt-reagent-fda-510k.jpg K904341 - APTT REAGENT K904341 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Chemical Co.. Cleared Nov 1990. https://www.510kdatabase.net/k903701/ 1990-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k903701-xpress-fda-510k.jpg K903701 - XPRESS K903701 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Nov 1990. https://www.510kdatabase.net/k903813/ 1990-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k903813-ureteral-balloon-dilatation-catheter-fda-510k.jpg K903813 - URETERAL BALLOON DILATATION CATHETER K903813 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Nov 1990. https://www.510kdatabase.net/k904033/ 1990-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k904033-reflotron-potassium-test-tabs-fda-510k.jpg K904033 - REFLOTRON POTASSIUM TEST TABS K904033 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Nov 1990. https://www.510kdatabase.net/k904307/ 1990-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k904307-dupont-salicylate-calibrator-fda-510k.jpg K904307 - DUPONT SALICYLATE CALIBRATOR K904307 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Nov 1990. https://www.510kdatabase.net/k902397/ 1990-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k902397-modulock-posterior-spinal-fixation-fda-510k.jpg K902397 - MODULOCK POSTERIOR SPINAL FIXATION K902397 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Nov 1990. https://www.510kdatabase.net/k903763/ 1990-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k903763-computed-tomography-x-ray-system-fda-510k.jpg K903763 - COMPUTED TOMOGRAPHY X-RAY SYSTEM K903763 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Nov 1990. https://www.510kdatabase.net/k904675/ 1990-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k904675-qbc-system-mchc-fda-510k.jpg K904675 - QBC SYSTEM MCHC K904675 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Nov 1990. https://www.510kdatabase.net/k904437/ 1990-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k904437-argenco-19-fda-510k.jpg K904437 - ARGENCO 19 K904437 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Nov 1990. https://www.510kdatabase.net/k900094/ 1990-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k900094-pe-mt-5-medi-tech-balloon-dilatation-fda-510k.jpg K900094 - PE-MT 5 MEDI-TECH BALLOON DILATATION CATHETER K900094 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Oct 1990. https://www.510kdatabase.net/k900217/ 1990-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k900217-bard-microbore-anti-siphon-nitro-set-fda-510k.jpg K900217 - BARD MICROBORE ANTI-SIPHON NITRO SET K900217 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 1990. https://www.510kdatabase.net/k903918/ 1990-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k903918-model-1850-electrode-fda-510k.jpg K903918 - MODEL 1850 ELECTRODE K903918 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Oct 1990. https://www.510kdatabase.net/k904343/ 1990-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k904343-argenco-22-fda-510k.jpg K904343 - ARGENCO 22 K904343 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Oct 1990. https://www.510kdatabase.net/k904467/ 1990-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k904467-argilite-3-fda-510k.jpg K904467 - ARGILITE 3 K904467 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Oct 1990. https://www.510kdatabase.net/k903636/ 1990-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k903636-osteonics-drm-acetabular-component-fda-510k.jpg K903636 - OSTEONICS DRM ACETABULAR COMPONENT K903636 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Oct 1990. https://www.510kdatabase.net/k904578/ 1990-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k904578-modification-auto-suturer-endoscopic-fda-510k.jpg K904578 - MODIFICATION AUTO SUTURE(R) ENDOSCOPIC CLAMP K904578 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Oct 1990. https://www.510kdatabase.net/k904226/ 1990-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k904226-tdxflx-analyzer-fda-510k.jpg K904226 - 'TDXFLX ANALYZER K904226 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1990. https://www.510kdatabase.net/k904221/ 1990-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k904221-sepacellr-pl-5a10a-leukocyte-removal-fda-510k.jpg K904221 - SEPACELL(R) PL-5A/10A LEUKOCYTE REMOVAL FILTERS K904221 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Oct 1990. https://www.510kdatabase.net/k904223/ 1990-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k904223-sepacellr-r-200500-leukocyte-removal-fda-510k.jpg K904223 - SEPACELL(R) R-200/500 LEUKOCYTE REMOVAL RECIP SETS K904223 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Oct 1990. https://www.510kdatabase.net/k904303/ 1990-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k904303-dupont-drug-clibrator-b-fda-510k.jpg K904303 - DUPONT DRUG CLIBRATOR-B K904303 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Oct 1990. https://www.510kdatabase.net/k904304/ 1990-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k904304-dupont-dimensionr-tobramllycintobr-fda-510k.jpg K904304 - DUPONT DIMENSION(R) TOBRAMLLYCIN(TOBR) METHOD K904304 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Oct 1990. https://www.510kdatabase.net/k904720/ 1990-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k904720-powercut-surgical-system-blades-and-fda-510k.jpg K904720 - POWERCUT SURGICAL SYSTEM, BLADES, AND ACCESSORIES K904720 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Baxter Healthcare Corp. Cleared Oct 1990. https://www.510kdatabase.net/k903523/ 1990-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k903523-hp-model-m1020a-arterial-oxygen-fda-510k.jpg K903523 - HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE K903523 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Oct 1990. https://www.510kdatabase.net/k903780/ 1990-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k903780-auto-suture-laparoscopy-accessory-kit-fda-510k.jpg K903780 - AUTO SUTURE LAPAROSCOPY ACCESSORY KIT K903780 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Oct 1990. https://www.510kdatabase.net/k903919/ 1990-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k903919-implantable-pulse-devices-fda-510k.jpg K903919 - IMPLANTABLE PULSE DEVICES K903919 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Oct 1990. https://www.510kdatabase.net/k903362/ 1990-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k903362-osteolocktm-acetabular-cup-fda-510k.jpg K903362 - OSTEOLOCK(TM) ACETABULAR CUP K903362 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Oct 1990. https://www.510kdatabase.net/k904205/ 1990-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k904205-amk-modular-tibial-wedge-system-fda-510k.jpg K904205 - AMK MODULAR TIBIAL WEDGE SYSTEM K904205 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Oct 1990. https://www.510kdatabase.net/k904292/ 1990-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k904292-accu-chekr-iii-blood-glucose-system-fda-510k.jpg K904292 - ACCU-CHEK(R) III BLOOD GLUCOSE SYSTEM K904292 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Oct 1990. https://www.510kdatabase.net/k904414/ 1990-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k904414-datascope-percor-stat-dl-95-fr40cc-fda-510k.jpg K904414 - DATASCOPE PERCOR STAT DL 9.5 FR40CC STERIL ETO GAS K904414 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Oct 1990. https://www.510kdatabase.net/k903769/ 1990-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k903769-percor-stat-dl-95-fr-34cc-intra-aortic-fda-510k.jpg K903769 - PERCOR STAT DL 9.5 FR 34CC INTRA-AORTIC BALLOON K903769 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Oct 1990. https://www.510kdatabase.net/k903867/ 1990-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k903867-datascope-percor-stat-dl-105-fr-40cc-fda-510k.jpg K903867 - DATASCOPE PERCOR STAT DL 10.5 FR 40CC K903867 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Oct 1990. https://www.510kdatabase.net/k903892/ 1990-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k903892-datascope-percor-stat-85-fr-40cc-intra-fda-510k.jpg K903892 - DATASCOPE PERCOR STAT 8.5 FR 40CC INTRA-AORTIC BAL K903892 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Oct 1990. https://www.510kdatabase.net/k903893/ 1990-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k903893-datascope-percor-stat-95-fr-40cc-intra-fda-510k.jpg K903893 - DATASCOPE PERCOR STAT 9.5 FR 40CC INTRA-AORTIC BAL K903893 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Oct 1990. https://www.510kdatabase.net/k904018/ 1990-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k904018-datascope-percor-stat-dl-95-fr-40cc-fda-510k.jpg K904018 - DATASCOPE PERCOR STAT DL 9.5 FR 40CC INTRA-AOR BAL K904018 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Oct 1990. https://www.510kdatabase.net/k903206/ 1990-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k903206-auto-suturer-endoscopic-scissors-fda-510k.jpg K903206 - AUTO SUTURE(R) ENDOSCOPIC SCISSORS K903206 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Oct 1990. https://www.510kdatabase.net/k904170/ 1990-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k904170-pca-r-tibial-bone-wedges-fda-510k.jpg K904170 - PCA (R) TIBIAL BONE WEDGES K904170 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Oct 1990. https://www.510kdatabase.net/k904351/ 1990-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k904351-focus-cobalt-chromium-total-hip-fda-510k.jpg K904351 - FOCUS COBALT CHROMIUM TOTAL HIP K904351 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Oct 1990. https://www.510kdatabase.net/k897106/ 1990-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k897106-medi-tech-dilatation-catheters-ultra-fda-510k.jpg K897106 - MEDI-TECH DILATATION CATHETERS ULTRA THIN II K897106 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Oct 1990. https://www.510kdatabase.net/k902143/ 1990-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k902143-fogarty-vessel-calibrator-fda-510k.jpg K902143 - FOGARTY VESSEL CALIBRATOR K902143 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Oct 1990. https://www.510kdatabase.net/k902342/ 1990-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k902342-unipolar-pediatric-temporary-pacing-fda-510k.jpg K902342 - UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, #6491 K902342 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Oct 1990. https://www.510kdatabase.net/k902932/ 1990-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k902932-datascope-percor-percutaneous-fda-510k.jpg K902932 - DATASCOPE PERCOR PERCUTANEOUS INTRODUCER W/PEELABL K902932 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Oct 1990. https://www.510kdatabase.net/k903687/ 1990-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k903687-turbiquant-myoglobin-fda-510k.jpg K903687 - TURBIQUANT MYOGLOBIN K903687 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Oct 1990. https://www.510kdatabase.net/k904036/ 1990-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k904036-bartels-cytomegalovirus-immed-early-fda-510k.jpg K904036 - BARTELS CYTOMEGALOVIRUS IMMED. EARLY ANTIGEN K904036 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Oct 1990. https://www.510kdatabase.net/k903626/ 1990-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k903626-biomek-automated-laboratory-fda-510k.jpg K903626 - BIOMEK AUTOMATED LABORATORY WORKSTATION W/GENELISA K903626 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Oct 1990. https://www.510kdatabase.net/k903742/ 1990-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k903742-add-mix-allergen-panel-mod-alastatr-fda-510k.jpg K903742 - ADD MIX ALLERGEN PANEL MOD ALASTAT(R) ALLERGEN IGE K903742 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Oct 1990. https://www.510kdatabase.net/k904168/ 1990-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k904168-accu-chek-r-easy-tm-blood-glucose-system-fda-510k.jpg K904168 - ACCU-CHEK (R) EASY (TM) BLOOD GLUCOSE SYSTEM K904168 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Oct 1990. https://www.510kdatabase.net/k904224/ 1990-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k904224-nova-lite-tm-thyroid-fda-510k.jpg K904224 - NOVA LITE TM THYROID K904224 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Oct 1990. https://www.510kdatabase.net/k904305/ 1990-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k904305-dupont-dimensionr-gentamicingent-method-fda-510k.jpg K904305 - DUPONT DIMENSION(R) GENTAMICIN(GENT) METHOD K904305 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Oct 1990. https://www.510kdatabase.net/k904306/ 1990-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k904306-dupont-drug-calibrator-a-fda-510k.jpg K904306 - DUPONT DRUG CALIBRATOR-A K904306 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Oct 1990. https://www.510kdatabase.net/k902786/ 1990-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k902786-milenia-tm-lh-fda-510k.jpg K902786 - MILENIA (TM) LH K902786 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Oct 1990. https://www.510kdatabase.net/k903124/ 1990-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k903124-laparoscopic-access-sheath-set-fda-510k.jpg K903124 - LAPAROSCOPIC ACCESS SHEATH SET K903124 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Cook, Inc.. Cleared Oct 1990. https://www.510kdatabase.net/k903146/ 1990-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k903146-hysteroscopy-sheath-set-fda-510k.jpg K903146 - HYSTEROSCOPY SHEATH SET K903146 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Cook, Inc.. Cleared Oct 1990. https://www.510kdatabase.net/k903304/ 1990-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k903304-roche-cobas-ready-ggt-reagent-fda-510k.jpg K903304 - ROCHE COBAS READY GGT REAGENT K903304 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Oct 1990. https://www.510kdatabase.net/k903396/ 1990-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k903396-il-t-uptake-assay-system-fda-510k.jpg K903396 - IL T UPTAKE ASSAY SYSTEM K903396 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Oct 1990. https://www.510kdatabase.net/k903433/ 1990-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k903433-tdx-free-t3-calculation-fda-510k.jpg K903433 - TDX FREE T3 CALCULATION K903433 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1990. https://www.510kdatabase.net/k903608/ 1990-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k903608-v-link-fda-510k.jpg K903608 - V-LINK K903608 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Oct 1990. https://www.510kdatabase.net/k904049/ 1990-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k904049-roche-cobas-ready-renal-profile-fda-510k.jpg K904049 - ROCHE COBAS READY RENAL PROFILE REAGENT STRIP K904049 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Oct 1990. https://www.510kdatabase.net/k904302/ 1990-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k904302-dupont-dimensionr-ethyl-alcoholalc-fda-510k.jpg K904302 - DUPONT DIMENSION(R) ETHYL ALCOHOL(ALC) METHOD K904302 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Oct 1990. https://www.510kdatabase.net/k904308/ 1990-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k904308-dupont-alcohol-calibrator-fda-510k.jpg K904308 - DUPONT ALCOHOL CALIBRATOR K904308 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Oct 1990. https://www.510kdatabase.net/k903205/ 1990-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k903205-auto-suturer-endoscopic-clamp-fda-510k.jpg K903205 - AUTO SUTURE(R) ENDOSCOPIC CLAMP K903205 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Oct 1990. https://www.510kdatabase.net/k903987/ 1990-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k903987-triflexr-orth-sterile-surgeons-gloves-fda-510k.jpg K903987 - TRIFLEX(R) ORTH STERILE SURGEON'S GLOVES, MODIFIED K903987 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Oct 1990. https://www.510kdatabase.net/k904119/ 1990-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k904119-profile-collared-hip-prosthesis-fda-510k.jpg K904119 - PROFILE COLLARED HIP PROSTHESIS K904119 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Oct 1990. https://www.510kdatabase.net/k901288/ 1990-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k901288-davol-scope-irrigation-system-fda-510k.jpg K901288 - DAVOL SCOPE IRRIGATION SYSTEM K901288 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 1990. https://www.510kdatabase.net/k903163/ 1990-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k903163-periodontal-debriding-solution-e-fda-510k.jpg K903163 - PERIODONTAL DEBRIDING SOLUTION E K903163 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Oct 1990. https://www.510kdatabase.net/k903858/ 1990-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k903858-cook-gianturco-rosch-biliary-z-stent-fda-510k.jpg K903858 - COOK-GIANTURCO ROSCH BILIARY Z-STENT, MODIFICATION K903858 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook, Inc.. Cleared Oct 1990. https://www.510kdatabase.net/k901235/ 1990-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k901235-greenfield-vena-cava-filter-w195-fr-fda-510k.jpg K901235 - GREENFIELD VENA CAVA FILTER W/19.5 FR INTRODUCER K901235 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Oct 1990. https://www.510kdatabase.net/k901780/ 1990-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k901780-rtm-36-05-60-05-rtd-36-05-60-05-radio-fda-510k.jpg K901780 - RTM 36-05, 60-05, RTD 36-05, 60-05 RADIO. LEADWIRE K901780 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Oct 1990. https://www.510kdatabase.net/k902245/ 1990-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k902245-sonicathtm-9f-12-mhz-fda-510k.jpg K902245 - SONICATH(TM) 9F, 12 MHZ K902245 is a FDA 510(k) cleared radiology medical device. Manufacturer: Boston Scientific Corp. Cleared Oct 1990. https://www.510kdatabase.net/k903736/ 1990-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k903736-datascope-percor-stat-dl105-fr40cc-in-fda-510k.jpg K903736 - DATASCOPE PERCOR STAT DL10.5 FR40CC IN AORTIC BAL K903736 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Oct 1990. https://www.510kdatabase.net/k903960/ 1990-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k903960-model-9444-teletrace-ii-ecg-monitoring-fda-510k.jpg K903960 - MODEL 9444 TELETRACE II ECG MONITORING SYSTEM K903960 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Oct 1990. https://www.510kdatabase.net/k904120/ 1990-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k904120-accu-flo-unitized-shunt-fda-510k.jpg K904120 - ACCU-FLO* UNITIZED SHUNT K904120 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Oct 1990. https://www.510kdatabase.net/k903085/ 1990-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k903085-sms-712na-fda-510k.jpg K903085 - SMS-712NA K903085 is a FDA 510(k) cleared neurology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Oct 1990. https://www.510kdatabase.net/k904358/ 1990-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k904358-model-855-enhanced-performance-remote-fda-510k.jpg K904358 - MODEL 855 ENHANCED PERFORMANCE REMOTE TERMINAL K904358 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Oct 1990. https://www.510kdatabase.net/k902575/ 1990-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k902575-sopheia-1000-s1cal-sopheia-2000-s2cal-fda-510k.jpg K902575 - SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL) K902575 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Oct 1990. https://www.510kdatabase.net/k903409/ 1990-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k903409-systemate-bicarbonate-olympus-fda-510k.jpg K903409 - SYSTEMATE BICARBONATE OLYMPUS BICARBONATE K903409 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Oct 1990. https://www.510kdatabase.net/k903933/ 1990-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k903933-dader-csfl-liq-cerebrospin-fluid-ctrl-fda-510k.jpg K903933 - DADE(R) CSF.L, LIQ CEREBROSPIN FLUID CTRL LEV 1&2 K903933 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Baxter Healthcare Corp. Cleared Oct 1990. https://www.510kdatabase.net/k903084/ 1990-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k903084-modular-cathcart-fracture-system-fda-510k.jpg K903084 - MODULAR CATHCART FRACTURE SYSTEM K903084 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Oct 1990. https://www.510kdatabase.net/k903914/ 1990-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k903914-paramax-cerebrospinal-fluidurine-fda-510k.jpg K903914 - PARAMAX CEREBROSPINAL FLUID/URINE PROTEIN BLANK K903914 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Baxter Healthcare Corp. Cleared Oct 1990. https://www.510kdatabase.net/k904238/ 1990-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k904238-kodak-x-mat-270-ra-processor-fda-510k.jpg K904238 - KODAK X-MAT 270 RA PROCESSOR K904238 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Oct 1990. https://www.510kdatabase.net/k902595/ 1990-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k902595-catarrhalis-test-strip-fda-510k.jpg K902595 - CATARRHALIS TEST STRIP K902595 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Oct 1990. https://www.510kdatabase.net/k903435/ 1990-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k903435-shiley-specialized-tracheostomy-tube-fda-510k.jpg K903435 - SHILEY SPECIALIZED TRACHEOSTOMY TUBE K903435 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shiley, Inc.. Cleared Oct 1990. https://www.510kdatabase.net/k903323/ 1990-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k903323-resectoscope-loops-fda-510k.jpg K903323 - RESECTOSCOPE LOOPS K903323 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Corp.. Cleared Oct 1990. https://www.510kdatabase.net/k901899/ 1990-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k901899-roadrunner-wire-guide-fda-510k.jpg K901899 - ROADRUNNER WIRE GUIDE K901899 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Sep 1990. https://www.510kdatabase.net/k902856/ 1990-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k902856-bard-filtered-cardiotomy-reservoir-fda-510k.jpg K902856 - BARD FILTERED CARDIOTOMY RESERVOIR K902856 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Sep 1990. https://www.510kdatabase.net/k902872/ 1990-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k902872-nonabsorbable-polypropylene-surgical-fda-510k.jpg K902872 - NONABSORBABLE POLYPROPYLENE SURGICAL SUTURE* K902872 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Sep 1990. https://www.510kdatabase.net/k902873/ 1990-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k902873-nonabsorbable-dacron-surgical-suture-fda-510k.jpg K902873 - NONABSORBABLE DACRON SURGICAL SUTURE* K902873 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Sep 1990. https://www.510kdatabase.net/k902935/ 1990-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k902935-roche-cobas-ready-hdl-cholesterol-fda-510k.jpg K902935 - ROCHE COBAS READY HDL CHOLESTEROL REAGENT K902935 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Sep 1990. https://www.510kdatabase.net/k903071/ 1990-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k903071-kodak-ektachem-solution-7bsa-bovine-fda-510k.jpg K903071 - KODAK EKTACHEM SOLUTION 7%BSA BOVINE SERUM ALBUMIN K903071 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Sep 1990. https://www.510kdatabase.net/k903305/ 1990-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k903305-technicon-chem-i-system-carbon-dioxide-fda-510k.jpg K903305 - TECHNICON CHEM I SYSTEM CARBON DIOXIDE METHOD K903305 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Sep 1990. https://www.510kdatabase.net/k903357/ 1990-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k903357-syvar-etsr-plus-system-fda-510k.jpg K903357 - SYVA(R) ETS(R) PLUS SYSTEM K903357 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Sep 1990. https://www.510kdatabase.net/k903527/ 1990-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k903527-magnetic-resonance-diagnostic-device-fda-510k.jpg K903527 - MAGNETIC RESONANCE DIAGNOSTIC DEVICE-OR 41 MAGNET K903527 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 1990. https://www.510kdatabase.net/k903824/ 1990-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k903824-drug-of-abuse-analysis-system-free-fda-510k.jpg K903824 - DRUG OF ABUSE ANALYSIS SYSTEM FREE RADICAL ASSAY K903824 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Sep 1990. https://www.510kdatabase.net/k903825/ 1990-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k903825-drug-of-abuse-analysis-system-fda-510k.jpg K903825 - DRUG OF ABUSE ANALYSIS SYSTEM K903825 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Sep 1990. https://www.510kdatabase.net/k903913/ 1990-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k903913-paramax-urinecsf-calibrator-level-i-fda-510k.jpg K903913 - PARAMAX URINE/CSF CALIBRATOR LEVEL I AND II K903913 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Baxter Healthcare Corp. Cleared Sep 1990. https://www.510kdatabase.net/k904102/ 1990-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k904102-reflotron-creatine-kinase-test-tabs-fda-510k.jpg K904102 - REFLOTRON CREATINE KINASE TEST TABS K904102 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Sep 1990. https://www.510kdatabase.net/k902002/ 1990-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k902002-models-50695071-myocardial-pacing-leads-fda-510k.jpg K902002 - MODELS 5069/5071 MYOCARDIAL PACING LEADS K902002 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Sep 1990. https://www.510kdatabase.net/k903707/ 1990-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k903707-deflecting-wire-grasper-fda-510k.jpg K903707 - DEFLECTING WIRE GRASPER K903707 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Cook, Inc.. Cleared Sep 1990. https://www.510kdatabase.net/k900881/ 1990-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k900881-or-340-intraoperative-ultrasound-system-fda-510k.jpg K900881 - OR-340 INTRAOPERATIVE ULTRASOUND SYSTEM K900881 is a FDA 510(k) cleared radiology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Sep 1990. https://www.510kdatabase.net/k902057/ 1990-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k902057-percor-stat-dl-85-fr-40cc-iab-fda-510k.jpg K902057 - PERCOR STAT DL 8.5 FR 40CC IAB ONLY/LABELING CHANG K902057 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Sep 1990. https://www.510kdatabase.net/k903144/ 1990-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k903144-kodak-ektachem-clinical-chemistry-fda-510k.jpg K903144 - KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (ECO2) K903144 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Sep 1990. https://www.510kdatabase.net/k903207/ 1990-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k903207-auto-suture-endoscopic-fda-510k.jpg K903207 - AUTO SUTURE ENDOSCOPIC SUCTION/IRRIGATRION DEVICE K903207 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Sep 1990. https://www.510kdatabase.net/k903219/ 1990-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k903219-abbott-testpack-plus-tm-hcg-combo-fda-510k.jpg K903219 - ABBOTT TESTPACK PLUS TM HCG-COMBO K903219 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1990. https://www.510kdatabase.net/k902726/ 1990-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k902726-bartels-extracellular-matrix-fda-510k.jpg K902726 - BARTELS EXTRACELLULAR MATRIX K902726 is a FDA 510(k) cleared pathology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Sep 1990. https://www.510kdatabase.net/k903566/ 1990-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k903566-dade-immunoassay-controls-levels-i-ii-fda-510k.jpg K903566 - DADE IMMUNOASSAY CONTROLS, LEVELS I, II, III K903566 is a FDA 510(k) cleared immunology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Sep 1990. https://www.510kdatabase.net/k902217/ 1990-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k902217-temporomandibular-joint-tmj-coil-fda-510k.jpg K902217 - TEMPOROMANDIBULAR JOINT (TMJ) COIL K902217 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 1990. https://www.510kdatabase.net/k902937/ 1990-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k902937-milenia-pap-irma-catalog-mkpa1-x-fda-510k.jpg K902937 - MILENIA PAP IRMA CATALOG #: MKPA1, X K902937 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Sep 1990. https://www.510kdatabase.net/k903377/ 1990-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k903377-computerized-tomography-x-ray-system-fda-510k.jpg K903377 - COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION K903377 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 1990. https://www.510kdatabase.net/k902544/ 1990-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k902544-sundt-avm-micro-clip-fda-510k.jpg K902544 - SUNDT AVM MICRO CLIP K902544 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Sep 1990. https://www.510kdatabase.net/k902663/ 1990-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k902663-ge-quadrature-tl-spine-surf-coil-fda-510k.jpg K902663 - GE QUADRATURE T/L SPINE SURF COIL, M1085AP/M1285AP K902663 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Sep 1990. https://www.510kdatabase.net/k902855/ 1990-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k902855-new-jersey-total-shoulder-glenoid-fda-510k.jpg K902855 - NEW JERSEY TOTAL SHOULDER GLENOID COMPONENT K902855 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Sep 1990. https://www.510kdatabase.net/k901524/ 1990-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k901524-chemfil-ii-caps-fda-510k.jpg K901524 - CHEMFIL II CAPS K901524 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Sep 1990. https://www.510kdatabase.net/k902432/ 1990-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k902432-ambulatory-infuser-and-assoc-flow-fda-510k.jpg K902432 - AMBULATORY INFUSER AND ASSOC. FLOW CONTROLLING SET K902432 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1990. https://www.510kdatabase.net/k903678/ 1990-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k903678-argenco-8-gold-alloy-for-porcelain-fda-510k.jpg K903678 - ARGENCO 8 GOLD ALLOY FOR PORCELAIN K903678 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Sep 1990. https://www.510kdatabase.net/k903743/ 1990-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k903743-il-gentamicin-assay-system-fda-510k.jpg K903743 - IL GENTAMICIN ASSAY SYSTEM K903743 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 1990. https://www.510kdatabase.net/k903926/ 1990-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k903926-kodak-surecell-herpes-hsv-control-fda-510k.jpg K903926 - KODAK SURECELL HERPES (HSV) CONTROL FLUID SET K903926 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Eastman Kodak Company. Cleared Sep 1990. https://www.510kdatabase.net/k900261/ 1990-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k900261-acsys-prefix-acetabular-cup-prosthesis-fda-510k.jpg K900261 - ACSYS PREFIX ACETABULAR CUP PROSTHESIS K900261 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 3M Company. Cleared Sep 1990. https://www.510kdatabase.net/k900262/ 1990-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k900262-acsys-selftap-acetabular-cup-prosthesis-fda-510k.jpg K900262 - ACSYS SELFTAP ACETABULAR CUP PROSTHESIS K900262 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 3M Company. Cleared Sep 1990. https://www.510kdatabase.net/k900435/ 1990-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k900435-acsys-shearer-acetabular-cup-prosthesis-fda-510k.jpg K900435 - ACSYS SHEARER ACETABULAR CUP PROSTHESIS K900435 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 3M Company. Cleared Sep 1990. https://www.510kdatabase.net/k902527/ 1990-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k902527-split-second-introducer-fda-510k.jpg K902527 - SPLIT-SECOND INTRODUCER K902527 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1990. https://www.510kdatabase.net/k902944/ 1990-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k902944-wittich-nitinol-stone-basket-fda-510k.jpg K902944 - WITTICH NITINOL STONE BASKET K902944 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook, Inc.. Cleared Sep 1990. https://www.510kdatabase.net/k902945/ 1990-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k902945-cope-nitinol-stone-basket-fda-510k.jpg K902945 - COPE NITINOL STONE BASKET K902945 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook, Inc.. Cleared Sep 1990. https://www.510kdatabase.net/k903198/ 1990-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k903198-alanine-aminotransferase-test-fda-510k.jpg K903198 - ALANINE AMINOTRANSFERASE TEST K903198 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Sep 1990. https://www.510kdatabase.net/k903696/ 1990-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k903696-olympus-inorganic-phosphorus-fda-510k.jpg K903696 - OLYMPUS INORGANIC PHOSPHORUS K903696 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Sep 1990. https://www.510kdatabase.net/k903758/ 1990-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k903758-syva-microtrak-eia-accessory-reagents-fda-510k.jpg K903758 - SYVA MICROTRAK EIA ACCESSORY REAGENTS K903758 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Syva Co.. Cleared Sep 1990. https://www.510kdatabase.net/k903818/ 1990-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k903818-argibond-dental-alloy-for-porcelain-fda-510k.jpg K903818 - ARGIBOND DENTAL ALLOY FOR PORCELAIN K903818 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Sep 1990. https://www.510kdatabase.net/k903819/ 1990-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k903819-argistar-45-gold-alloy-for-porcelain-fda-510k.jpg K903819 - ARGISTAR 45 GOLD ALLOY FOR PORCELAIN K903819 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Sep 1990. https://www.510kdatabase.net/k903830/ 1990-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k903830-novabond-gold-alloy-for-porcelain-fda-510k.jpg K903830 - NOVABOND GOLD ALLOY FOR PORCELAIN K903830 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Sep 1990. https://www.510kdatabase.net/k903831/ 1990-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k903831-argicraft-1-palladium-silver-alloy-for-fda-510k.jpg K903831 - ARGICRAFT 1 PALLADIUM SILVER ALLOY FOR PORCELAIN K903831 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Sep 1990. https://www.510kdatabase.net/k903832/ 1990-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k903832-argicraft-2-palladium-silver-alloy-for-fda-510k.jpg K903832 - ARGICRAFT 2 PALLADIUM SILVER ALLOY FOR PORCELAIN K903832 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Sep 1990. https://www.510kdatabase.net/k903833/ 1990-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k903833-dentabond-gold-alloy-for-porcelain-fda-510k.jpg K903833 - DENTABOND GOLD ALLOY FOR PORCELAIN K903833 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Sep 1990. https://www.510kdatabase.net/k896830/ 1990-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k896830-optimate-hemoglobin-a1c-fda-510k.jpg K896830 - OPTIMATE HEMOGLOBIN A1C K896830 is a FDA 510(k) cleared hematology medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Sep 1990. https://www.510kdatabase.net/k901736/ 1990-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k901736-oximetry-probe-catheters-fda-510k.jpg K901736 - OXIMETRY PROBE CATHETERS K901736 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Sep 1990. https://www.510kdatabase.net/k902609/ 1990-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k902609-directigen-flu-a-fda-510k.jpg K902609 - DIRECTIGEN FLU A K902609 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1990. https://www.510kdatabase.net/k903188/ 1990-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k903188-abbott-vision-lyte-tm-sodium-fda-510k.jpg K903188 - ABBOTT VISION LYTE (TM) SODIUM K903188 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1990. https://www.510kdatabase.net/k903383/ 1990-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k903383-tdx-free-t4-calculation-fda-510k.jpg K903383 - TDX FREE T4 CALCULATION K903383 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1990. https://www.510kdatabase.net/k903384/ 1990-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k903384-imx-free-t4-calculation-fda-510k.jpg K903384 - IMX FREE T4 CALCULATION K903384 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1990. https://www.510kdatabase.net/k902561/ 1990-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k902561-roche-cobas-ready-creatinine-reagent-fda-510k.jpg K902561 - ROCHE COBAS READY CREATININE REAGENT K902561 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Sep 1990. https://www.510kdatabase.net/k902731/ 1990-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k902731-endoscopic-hemostatic-ligating-loop-fda-510k.jpg K902731 - ENDOSCOPIC HEMOSTATIC LIGATING LOOP K902731 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Sep 1990. https://www.510kdatabase.net/k902834/ 1990-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k902834-abbott-imx-free-t4-fda-510k.jpg K902834 - ABBOTT IMX FREE T4 K902834 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1990. https://www.510kdatabase.net/k902979/ 1990-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k902979-milenia-tm-amphetamine-fda-510k.jpg K902979 - MILENIA (TM) AMPHETAMINE K902979 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Sep 1990. https://www.510kdatabase.net/k903309/ 1990-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k903309-roche-cobas-ready-amylase-reagent-fda-510k.jpg K903309 - ROCHE COBAS READY AMYLASE REAGENT K903309 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Sep 1990. https://www.510kdatabase.net/k903311/ 1990-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k903311-novapath-tsh-enzyme-immunoassay-fda-510k.jpg K903311 - NOVAPATH TSH ENZYME IMMUNOASSAY K903311 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Sep 1990. https://www.510kdatabase.net/k903334/ 1990-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k903334-urea-nitrogen-test-fda-510k.jpg K903334 - UREA NITROGEN TEST K903334 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Sep 1990. https://www.510kdatabase.net/k903407/ 1990-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k903407-affinity-hlh-test-system-fda-510k.jpg K903407 - AFFINITY HLH TEST SYSTEM K903407 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1990. https://www.510kdatabase.net/k903432/ 1990-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k903432-imx-free-t3-calculation-fda-510k.jpg K903432 - IMX FREE T3 CALCULATION K903432 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1990. https://www.510kdatabase.net/k903573/ 1990-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k903573-reflotron-creatinine-test-tabs-fda-510k.jpg K903573 - REFLOTRON CREATININE TEST TABS K903573 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Sep 1990. https://www.510kdatabase.net/k901580/ 1990-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k901580-prophy-paste-fda-510k.jpg K901580 - PROPHY PASTE K901580 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Sep 1990. https://www.510kdatabase.net/k901940/ 1990-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k901940-luhr-micro-mesh-fda-510k.jpg K901940 - LUHR MICRO MESH K901940 is a FDA 510(k) cleared dental medical device. Manufacturer: Howmedica Corp.. Cleared Sep 1990. https://www.510kdatabase.net/k901941/ 1990-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k901941-luhr-mandibular-compressionreconstructio-fda-510k.jpg K901941 - LUHR MANDIBULAR COMPRESSION/RECONSTRUCTION PLATES K901941 is a FDA 510(k) cleared dental medical device. Manufacturer: Howmedica Corp.. Cleared Sep 1990. https://www.510kdatabase.net/k903548/ 1990-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k903548-argenco-9-fda-510k.jpg K903548 - ARGENCO 9 K903548 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Sep 1990. https://www.510kdatabase.net/k903549/ 1990-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k903549-argenco-25-fda-510k.jpg K903549 - ARGENCO 25 K903549 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Sep 1990. https://www.510kdatabase.net/k903677/ 1990-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k903677-argident-2a-dental-gold-alloy-for-fda-510k.jpg K903677 - ARGIDENT 2A DENTAL GOLD ALLOY FOR PORECLAIN K903677 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Sep 1990. https://www.510kdatabase.net/k901641/ 1990-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k901641-axillobifemoral-gore-tex-vascular-graft-fda-510k.jpg K901641 - AXILLOBIFEMORAL GORE-TEX VASCULAR GRAFT K901641 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Sep 1990. https://www.510kdatabase.net/k902220/ 1990-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k902220-precipathr-im-normal-abnormal-immuno-fda-510k.jpg K902220 - PRECIPATH(R) IM NORMAL & ABNORMAL IMMUNO. CONTROL K902220 is a FDA 510(k) cleared immunology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Sep 1990. https://www.510kdatabase.net/k903898/ 1990-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k903898-quanta-lite-tm-dsdna-fda-510k.jpg K903898 - QUANTA LITE TM DSDNA K903898 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Sep 1990. https://www.510kdatabase.net/k902576/ 1990-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k902576-alastat-allergen-spec-ige-control-fda-510k.jpg K902576 - ALASTAT ALLERGEN-SPEC IGE CONTROL DC1A/2A/6A/NGCA K902576 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Sep 1990. https://www.510kdatabase.net/k902905/ 1990-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k902905-cook-coronary-guiding-catheter-fda-510k.jpg K902905 - COOK CORONARY GUIDING CATHETER K902905 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Sep 1990. https://www.510kdatabase.net/k902624/ 1990-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k902624-bd-flexible-digital-thermometer-fda-510k.jpg K902624 - BD FLEXIBLE DIGITAL THERMOMETER K902624 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1990. https://www.510kdatabase.net/k903048/ 1990-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k903048-vista-mr-2055-hp-system-fda-510k.jpg K903048 - VISTA MR 2055 HP SYSTEM K903048 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k903680/ 1990-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k903680-argident-yellow-3-gold-alloy-for-fda-510k.jpg K903680 - ARGIDENT YELLOW 3 GOLD ALLOY FOR PORCELAIN K903680 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k903681/ 1990-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k903681-argident-yellow-1-gold-alloy-for-fda-510k.jpg K903681 - ARGIDENT YELLOW 1 GOLD ALLOY FOR PORCELAIN K903681 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k903682/ 1990-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k903682-argilite-1-gold-alloy-for-porcelain-fda-510k.jpg K903682 - ARGILITE 1 GOLD ALLOY FOR PORCELAIN K903682 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k903683/ 1990-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k903683-argilite-2-gold-alloy-for-porcelain-fda-510k.jpg K903683 - ARGILITE 2 GOLD ALLOY FOR PORCELAIN K903683 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k903684/ 1990-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k903684-argident-3-gold-alloy-for-porcelain-fda-510k.jpg K903684 - ARGIDENT 3 GOLD ALLOY FOR PORCELAIN K903684 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k903685/ 1990-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k903685-argident-k-gold-alloy-for-porcelain-fda-510k.jpg K903685 - ARGIDENT K GOLD ALLOY FOR PORCELAIN K903685 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k903852/ 1990-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k903852-rapitexr-rf-new-fda-510k.jpg K903852 - RAPITEX(R) RF NEW K903852 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k903853/ 1990-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k903853-rapitex-r-crp-new-fda-510k.jpg K903853 - RAPITEX (R) CRP NEW K903853 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k900483/ 1990-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k900483-varidyne-at-postoperative-orthopedic-fda-510k.jpg K900483 - VARIDYNE AT POSTOPERATIVE ORTHOPEDIC AUTOTRANSFU. K900483 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Aug 1990. https://www.510kdatabase.net/k902436/ 1990-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k902436-hg-multilock-hip-prosthesis-wtinidium-fda-510k.jpg K902436 - HG MULTILOCK HIP PROSTHESIS W/TINIDIUM SURFACE K902436 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k903306/ 1990-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k903306-technicon-chem-i-system-magnesium-method-fda-510k.jpg K903306 - TECHNICON CHEM I SYSTEM MAGNESIUM METHOD K903306 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Aug 1990. https://www.510kdatabase.net/k903550/ 1990-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k903550-topcast-fda-510k.jpg K903550 - TOPCAST K903550 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k903679/ 1990-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k903679-argident-yellow-2-gold-alloy-for-fda-510k.jpg K903679 - ARGIDENT YELLOW 2 GOLD ALLOY FOR PROCELAIN K903679 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k903686/ 1990-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k903686-argilite-4-gold-alloy-for-porcelain-fda-510k.jpg K903686 - ARGILITE 4 GOLD ALLOY FOR PORCELAIN K903686 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k902070/ 1990-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k902070-radius-and-sonochrome-fda-510k.jpg K902070 - RADIUS AND SONOCHROME K902070 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Aug 1990. https://www.510kdatabase.net/k900467/ 1990-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k900467-lifecare-model-4-pump-fda-510k.jpg K900467 - LIFECARE MODEL 4 PUMP K900467 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1990. https://www.510kdatabase.net/k900468/ 1990-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k900468-lifecarer-model-3-pump-fda-510k.jpg K900468 - LIFECARE(R) MODEL 3 PUMP K900468 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1990. https://www.510kdatabase.net/k902395/ 1990-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k902395-modified-aml-acetabular-cup-system-fda-510k.jpg K902395 - MODIFIED AML + ACETABULAR CUP SYSTEM K902395 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k902396/ 1990-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k902396-modified-depuy-acetabular-cup-system-fda-510k.jpg K902396 - MODIFIED DEPUY ACETABULAR CUP SYSTEM K902396 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k902736/ 1990-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k902736-nm-injection-needles-fda-510k.jpg K902736 - NM INJECTION NEEDLES K902736 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Corp.. Cleared Aug 1990. https://www.510kdatabase.net/k902737/ 1990-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k902737-bc-brushes-fda-510k.jpg K902737 - BC BRUSHES K902737 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Corp.. Cleared Aug 1990. https://www.510kdatabase.net/k900515/ 1990-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k900515-models-6207620862096210621162126214-plis-fda-510k.jpg K900515 - MODELS 6207/6208/6209/6210/6211/6212/6214 (PLI'S) K900515 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Aug 1990. https://www.510kdatabase.net/k900805/ 1990-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k900805-aloka-500-diagnostic-ultrasound-fda-510k.jpg K900805 - ALOKA 500 DIAGNOSTIC ULTRASOUND SCANNING SYSTEM K900805 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Aug 1990. https://www.510kdatabase.net/k901225/ 1990-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k901225-life-shield-disposable-pressure-infusor-fda-510k.jpg K901225 - LIFE SHIELD (DISPOSABLE PRESSURE INFUSOR) K901225 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1990. https://www.510kdatabase.net/k902355/ 1990-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k902355-mcr4000-mcr4000f-cardiotomy-reservoir-fda-510k.jpg K902355 - MCR4000 & MCR4000F CARDIOTOMY RESERVOIR K902355 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Aug 1990. https://www.510kdatabase.net/k902933/ 1990-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k902933-teslacon-magnetic-resonance-diagnostic-fda-510k.jpg K902933 - TESLACON (MAGNETIC RESONANCE DIAGNOSTIC DEVICE) K902933 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Aug 1990. https://www.510kdatabase.net/k903095/ 1990-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k903095-il-thyroxine-t4-assay-system-fda-510k.jpg K903095 - IL THYROXINE (T4) ASSAY SYSTEM K903095 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Aug 1990. https://www.510kdatabase.net/k903218/ 1990-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k903218-imx-b12-fda-510k.jpg K903218 - IMX B12 K903218 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1990. https://www.510kdatabase.net/k903430/ 1990-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k903430-liquichek-ckld-isoenzyme-control-fda-510k.jpg K903430 - LIQUICHEK CK/LD ISOENZYME CONTROL K903430 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Aug 1990. https://www.510kdatabase.net/k902734/ 1990-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k902734-pr-cannulas-fda-510k.jpg K902734 - PR CANNULAS K902734 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Corp.. Cleared Aug 1990. https://www.510kdatabase.net/k902952/ 1990-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k902952-il-phenytoin-assay-system-fda-510k.jpg K902952 - IL PHENYTOIN ASSAY SYSTEM K902952 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Aug 1990. https://www.510kdatabase.net/k903189/ 1990-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k903189-kodatrol-liquid-control-levels-i-ii-fda-510k.jpg K903189 - KODATROL LIQUID CONTROL LEVELS I & II K903189 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Aug 1990. https://www.510kdatabase.net/k903192/ 1990-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k903192-il-tobramycin-assay-fda-510k.jpg K903192 - IL TOBRAMYCIN ASSAY K903192 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Aug 1990. https://www.510kdatabase.net/k903194/ 1990-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k903194-reditest-strep-a-test-kit-fda-510k.jpg K903194 - REDITEST STREP A TEST KIT K903194 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Aug 1990. https://www.510kdatabase.net/k903316/ 1990-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k903316-aloka-ust-964p-5-endovaginal-transducer-fda-510k.jpg K903316 - ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER K903316 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Aug 1990. https://www.510kdatabase.net/k903425/ 1990-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k903425-haemophilus-test-medium-htm-broth-fda-510k.jpg K903425 - HAEMOPHILUS TEST MEDIUM (HTM) BROTH K903425 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1990. https://www.510kdatabase.net/k901360/ 1990-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k901360-leveen-peritineo-venous-shunt-fda-510k.jpg K901360 - LEVEEN PERITINEO-VENOUS SHUNT K901360 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1990. https://www.510kdatabase.net/k896224/ 1990-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k896224-cobas-ready-calcium-reagent-fda-510k.jpg K896224 - COBAS READY CALCIUM REAGENT K896224 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k896497/ 1990-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k896497-percor-stat-dl-85-fr-intra-aortic-fda-510k.jpg K896497 - PERCOR STAT-DL 8.5 FR INTRA-AORTIC BALLOON K896497 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Aug 1990. https://www.510kdatabase.net/k901952/ 1990-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k901952-mag-reson-diag-dev-access-spec-purp-fda-510k.jpg K901952 - MAG RESON DIAG DEV ACCESS SPEC PURP REC ONLY COIL K901952 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k902276/ 1990-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k902276-respironics-bipap-pressure-alarm-bipap-fda-510k.jpg K902276 - RESPIRONICS BIPAP PRESSURE ALARM (BIPAP P.A.) K902276 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k902370/ 1990-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k902370-modified-prostatic-urethroplasty-fda-510k.jpg K902370 - MODIFIED PROSTATIC URETHROPLASTY BALLOON CATHETER K902370 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Aug 1990. https://www.510kdatabase.net/k902557/ 1990-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k902557-xpeed-computed-tomography-x-ray-system-fda-510k.jpg K902557 - XPEED COMPUTED TOMOGRAPHY X-RAY SYSTEM K902557 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Aug 1990. https://www.510kdatabase.net/k902732/ 1990-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k902732-kodak-x-omat-460-ra-processor-fda-510k.jpg K902732 - KODAK X-OMAT 460 RA PROCESSOR K902732 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Aug 1990. https://www.510kdatabase.net/k902960/ 1990-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k902960-mileniatm-pcp-fda-510k.jpg K902960 - MILENIA(TM) PCP K902960 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Aug 1990. https://www.510kdatabase.net/k903152/ 1990-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k903152-emit-ethyl-alcohol-calibrators-and-fda-510k.jpg K903152 - EMIT ETHYL ALCOHOL CALIBRATORS AND CONTROLS K903152 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Aug 1990. https://www.510kdatabase.net/k903197/ 1990-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k903197-aspartate-aminotransferase-test-fda-510k.jpg K903197 - ASPARTATE AMINOTRANSFERASE TEST K903197 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k903228/ 1990-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k903228-emit-ets-plus-ethyl-alcohol-assay-fda-510k.jpg K903228 - EMIT ETS PLUS ETHYL ALCOHOL ASSAY K903228 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Aug 1990. https://www.510kdatabase.net/k903319/ 1990-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k903319-magnetic-resonance-diagnostic-device-fda-510k.jpg K903319 - MAGNETIC RESONANCE DIAGNOSTIC DEVICE K903319 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Aug 1990. https://www.510kdatabase.net/k903332/ 1990-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k903332-systemate-amylase-amyl-item-number-65404-fda-510k.jpg K903332 - SYSTEMATE AMYLASE (AMYL) ITEM NUMBER 65404 K903332 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k903333/ 1990-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k903333-creatine-kinase-test-ck-item-number-fda-510k.jpg K903333 - CREATINE KINASE TEST (CK) ITEM NUMBER 65411 K903333 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k903335/ 1990-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k903335-systemate-uric-acid-urca-item-number-fda-510k.jpg K903335 - SYSTEMATE URIC ACID (URCA) ITEM NUMBER 65422 K903335 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k900056/ 1990-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k900056-catheter-with-guidewire-assembly-device-fda-510k.jpg K900056 - CATHETER WITH GUIDEWIRE ASSEMBLY DEVICE K900056 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1990. https://www.510kdatabase.net/k902277/ 1990-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k902277-bard-extracorporeal-circulation-cannulae-fda-510k.jpg K902277 - BARD EXTRACORPOREAL CIRCULATION CANNULAE K902277 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k902898/ 1990-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k902898-argenco-m-4-type-ii-dental-gold-alloy-fda-510k.jpg K902898 - ARGENCO M-4 TYPE II DENTAL GOLD ALLOY K902898 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k902413/ 1990-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k902413-sonic-scaler-fda-510k.jpg K902413 - SONIC SCALER K902413 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Aug 1990. https://www.510kdatabase.net/k903009/ 1990-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k903009-argenco-iii-fda-510k.jpg K903009 - ARGENCO III K903009 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k903060/ 1990-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k903060-argenco-34-fda-510k.jpg K903060 - ARGENCO 34 K903060 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k903118/ 1990-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k903118-argenco-7a-fda-510k.jpg K903118 - ARGENCO 7A K903118 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k903232/ 1990-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k903232-argenco-5-fda-510k.jpg K903232 - ARGENCO 5 K903232 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k903275/ 1990-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k903275-argenco-36-fda-510k.jpg K903275 - ARGENCO 36 K903275 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k903276/ 1990-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k903276-argenco-33-kf-fda-510k.jpg K903276 - ARGENCO 33 KF K903276 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k903277/ 1990-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k903277-argicast-b-fda-510k.jpg K903277 - ARGICAST B K903277 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k903279/ 1990-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k903279-argenco-75-fda-510k.jpg K903279 - ARGENCO 75 K903279 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k903281/ 1990-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k903281-argenco-4-fda-510k.jpg K903281 - ARGENCO 4 K903281 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k903282/ 1990-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k903282-argenco-12-fda-510k.jpg K903282 - ARGENCO 12 K903282 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k903283/ 1990-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k903283-argenco-iv-fda-510k.jpg K903283 - ARGENCO IV K903283 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k901335/ 1990-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k901335-aloka-ust-5514dtu-75-linear-doppler-fda-510k.jpg K901335 - ALOKA UST-5514DTU-7.5 LINEAR DOPPLER TRANSDUCER K901335 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Aug 1990. https://www.510kdatabase.net/k903196/ 1990-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k903196-image-intensified-fluoroscopic-x-ray-fda-510k.jpg K903196 - IMAGE INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM K903196 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Aug 1990. https://www.510kdatabase.net/k901449/ 1990-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k901449-vacutainer-plus-with-hemogard-closure-fda-510k.jpg K901449 - VACUTAINER PLUS WITH HEMOGARD CLOSURE K901449 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1990. https://www.510kdatabase.net/k902098/ 1990-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k902098-cholesterol-rate-reagent-fda-510k.jpg K902098 - CHOLESTEROL (RATE) REAGENT K902098 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Aug 1990. https://www.510kdatabase.net/k902124/ 1990-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k902124-dowd-catheter-fda-510k.jpg K902124 - DOWD CATHETER K902124 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Aug 1990. https://www.510kdatabase.net/k902246/ 1990-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k902246-amk-universal-femoral-component-fda-510k.jpg K902246 - AMK UNIVERSAL FEMORAL COMPONENT K902246 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k902568/ 1990-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k902568-reflotron-hdl-cholesterol-test-tabs-fda-510k.jpg K902568 - REFLOTRON HDL CHOLESTEROL TEST TABS K902568 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Aug 1990. https://www.510kdatabase.net/k902569/ 1990-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k902569-precinorm-hdl-cholesterol-control-fda-510k.jpg K902569 - PRECINORM HDL CHOLESTEROL CONTROL MATERIAL FOR REF K902569 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Aug 1990. https://www.510kdatabase.net/k902712/ 1990-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k902712-osteonics-ps-head-and-neck-hip-stem-fda-510k.jpg K902712 - OSTEONICS PS HEAD AND NECK HIP STEM SERIES K902712 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Aug 1990. https://www.510kdatabase.net/k902720/ 1990-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k902720-affinity-hcg-test-system-fda-510k.jpg K902720 - AFFINITY HCG TEST SYSTEM K902720 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1990. https://www.510kdatabase.net/k902899/ 1990-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k902899-argenco-10-type-i-dental-gold-alloy-fda-510k.jpg K902899 - ARGENCO 10 TYPE I DENTAL GOLD ALLOY K902899 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k902900/ 1990-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k902900-argenco-m-1-type-ii-dental-gold-alloy-fda-510k.jpg K902900 - ARGENCO M-1 TYPE II DENTAL GOLD ALLOY K902900 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k902901/ 1990-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k902901-argenco-16-type-i-dental-gold-alloy-fda-510k.jpg K902901 - ARGENCO 16 TYPE I DENTAL GOLD ALLOY K902901 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k902903/ 1990-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k902903-argenco-17-type-ii-dental-gold-alloy-fda-510k.jpg K902903 - ARGENCO 17 TYPE II DENTAL GOLD ALLOY K902903 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k902904/ 1990-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k902904-argenco-20-20-ct-type-ii-dental-gold-fda-510k.jpg K902904 - ARGENCO 20 (20 CT) TYPE II DENTAL GOLD ALLOY K902904 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k903025/ 1990-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k903025-roche-isomune-ck-fda-510k.jpg K903025 - ROCHE ISOMUNE- CK K903025 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k903059/ 1990-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k903059-argenco-18-fda-510k.jpg K903059 - ARGENCO 18 K903059 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k903119/ 1990-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k903119-argenco-1-fda-510k.jpg K903119 - ARGENCO 1 K903119 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k903120/ 1990-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k903120-argenco-23-fda-510k.jpg K903120 - ARGENCO 23 K903120 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k903153/ 1990-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k903153-emit-ethyl-alcohol-assay-fda-510k.jpg K903153 - EMIT ETHYL ALCOHOL ASSAY K903153 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Aug 1990. https://www.510kdatabase.net/k903419/ 1990-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k903419-modified-surgiport-disposable-trocar-fda-510k.jpg K903419 - MODIFIED SURGIPORT DISPOSABLE TROCAR AND SLEEVE K903419 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Aug 1990. https://www.510kdatabase.net/k901777/ 1990-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k901777-3m-first-aid-bandage-for-minor-wounds-fda-510k.jpg K901777 - 3M FIRST AID BANDAGE FOR MINOR WOUNDS K901777 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3M Company. Cleared Aug 1990. https://www.510kdatabase.net/k902088/ 1990-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k902088-modified-software-to-the-sonos-100-fda-510k.jpg K902088 - MODIFIED SOFTWARE TO THE SONOS 100 ULTRASOUND K902088 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Aug 1990. https://www.510kdatabase.net/k902665/ 1990-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k902665-argenco-y-type-iiiiv-dental-alloy-fda-510k.jpg K902665 - ARGENCO Y (TYPE III/IV DENTAL ALLOY CROWN/BRIDGE K902665 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k901977/ 1990-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k901977-beckman-antithrombin-iii-reagent-kit-fda-510k.jpg K901977 - BECKMAN ANTITHROMBIN III REAGENT KIT K901977 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k902108/ 1990-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k902108-hem-o-loktm-fda-510k.jpg K902108 - HEM-O-LOK(TM) K902108 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k902902/ 1990-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k902902-argenco-6-type-ii-dental-gold-alloy-fda-510k.jpg K902902 - ARGENCO 6 TYPE II DENTAL GOLD ALLOY K902902 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k902966/ 1990-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k902966-argenco-2-type-iii-dental-gold-alloy-fda-510k.jpg K902966 - ARGENCO 2 TYPE III DENTAL GOLD ALLOY K902966 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k903274/ 1990-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k903274-argenco-nordic-fda-510k.jpg K903274 - ARGENCO NORDIC K903274 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k903278/ 1990-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k903278-argenco-28-fda-510k.jpg K903278 - ARGENCO 28 K903278 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k903280/ 1990-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k903280-argenco-27-fda-510k.jpg K903280 - ARGENCO 27 K903280 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k900375/ 1990-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k900375-becton-dickinson-program-2-infusion-pump-fda-510k.jpg K900375 - BECTON DICKINSON PROGRAM 2 INFUSION PUMP K900375 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1990. https://www.510kdatabase.net/k901981/ 1990-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k901981-abbott-modified-fact-plus-pregnancy-test-fda-510k.jpg K901981 - ABBOTT MODIFIED FACT PLUS PREGNANCY TEST K901981 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1990. https://www.510kdatabase.net/k902232/ 1990-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k902232-weck-electrosurgical-generator-174200-fda-510k.jpg K902232 - WECK ELECTROSURGICAL GENERATOR #174200 K902232 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k902430/ 1990-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k902430-glucolet-2-automatic-lancing-device-fda-510k.jpg K902430 - GLUCOLET 2 AUTOMATIC LANCING DEVICE FOR OB. BLOOD K902430 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Aug 1990. https://www.510kdatabase.net/k902735/ 1990-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k902735-sd-snares-fda-510k.jpg K902735 - SD SNARES K902735 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Olympus Corp.. Cleared Aug 1990. https://www.510kdatabase.net/k902997/ 1990-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k902997-milenia-tm-ferritin-fda-510k.jpg K902997 - MILENIA (TM) FERRITIN K902997 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Aug 1990. https://www.510kdatabase.net/k901252/ 1990-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k901252-hewlett-packard-series-of-disposable-fda-510k.jpg K901252 - HEWLETT-PACKARD SERIES OF DISPOSABLE NIBP CUFFS K901252 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Jul 1990. https://www.510kdatabase.net/k902661/ 1990-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k902661-bartels-herpes-simplex-vir-flu-mono-fda-510k.jpg K902661 - BARTELS HERPES SIMPLEX VIR FLU MONO ANTIB HSV-1&2 K902661 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jul 1990. https://www.510kdatabase.net/k902662/ 1990-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k902662-bartels-herpes-simplex-vir-flu-mono-fda-510k.jpg K902662 - BARTELS HERPES SIMPLEX VIR FLU MONO ANTIBODY TEST K902662 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jul 1990. https://www.510kdatabase.net/k900473/ 1990-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k900473-imx-cmv-igm-antibody-assay-fda-510k.jpg K900473 - IMX CMV IGM ANTIBODY ASSAY K900473 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Jul 1990. https://www.510kdatabase.net/k900474/ 1990-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k900474-imx-cmv-igg-antibody-assay-fda-510k.jpg K900474 - IMX CMV IGG ANTIBODY ASSAY K900474 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Jul 1990. https://www.510kdatabase.net/k902577/ 1990-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k902577-emitr-ii-opiate-assay-fda-510k.jpg K902577 - EMIT(R) II OPIATE ASSAY K902577 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jul 1990. https://www.510kdatabase.net/k902579/ 1990-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k902579-emitr-ii-cocaine-metabolite-assay-fda-510k.jpg K902579 - EMIT(R) II COCAINE METABOLITE ASSAY K902579 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jul 1990. https://www.510kdatabase.net/k902581/ 1990-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k902581-emitr-ii-calibrator-level-0-negative-fda-510k.jpg K902581 - EMIT(R) II CALIBRATOR LEVEL 0 (NEGATIVE) K902581 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jul 1990. https://www.510kdatabase.net/k902633/ 1990-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k902633-cut-resistant-glove-liner-fda-510k.jpg K902633 - CUT RESISTANT GLOVE LINER K902633 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Biomet, Inc.. Cleared Jul 1990. https://www.510kdatabase.net/k901442/ 1990-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k901442-baxter-d-c-tray-fda-510k.jpg K901442 - BAXTER D & C TRAY K901442 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jul 1990. https://www.510kdatabase.net/k902361/ 1990-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k902361-coagulation-control-level-i-fda-510k.jpg K902361 - COAGULATION CONTROL, LEVEL I K902361 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Chemical Co.. Cleared Jul 1990. https://www.510kdatabase.net/k902362/ 1990-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k902362-coagulation-control-level-ii-fda-510k.jpg K902362 - COAGULATION CONTROL, LEVEL II K902362 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Chemical Co.. Cleared Jul 1990. https://www.510kdatabase.net/k902363/ 1990-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k902363-coagulation-control-level-iii-fda-510k.jpg K902363 - COAGULATION CONTROL, LEVEL III K902363 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Chemical Co.. Cleared Jul 1990. https://www.510kdatabase.net/k901772/ 1990-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k901772-kodak-m35a-m-x-omat-processor-fda-510k.jpg K901772 - KODAK M35A-M X-OMAT PROCESSOR K901772 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Jul 1990. https://www.510kdatabase.net/k901829/ 1990-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k901829-behring-chromotimer-fda-510k.jpg K901829 - BEHRING CHROMOTIMER K901829 is a FDA 510(k) cleared hematology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Jul 1990. https://www.510kdatabase.net/k901406/ 1990-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k901406-anatomic-modular-knee-amk-posterior-fda-510k.jpg K901406 - ANATOMIC MODULAR KNEE (AMK) POSTERIOR STABILIZED K901406 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jul 1990. https://www.510kdatabase.net/k901845/ 1990-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k901845-tegaderm-brand-transparent-dressing-fda-510k.jpg K901845 - TEGADERM BRAND TRANSPARENT DRESSING SERIES 16XX K901845 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3M Company. Cleared Jul 1990. https://www.510kdatabase.net/k902036/ 1990-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k902036-steri-vac-gas-sterilizer-model-5xl-fda-510k.jpg K902036 - STERI-VAC GAS STERILIZER MODEL 5XL K902036 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Jul 1990. https://www.510kdatabase.net/k902257/ 1990-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k902257-codman-external-drainage-system-ii-eds-fda-510k.jpg K902257 - CODMAN* EXTERNAL DRAINAGE SYSTEM II (EDS-II) K902257 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Jul 1990. https://www.510kdatabase.net/k902409/ 1990-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k902409-becton-dickinson-360-infuser-tm-system-fda-510k.jpg K902409 - BECTON DICKINSON 360 INFUSER (TM) SYSTEM K902409 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jul 1990. https://www.510kdatabase.net/k902580/ 1990-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k902580-emitr-ii-barbiturate-assay-fda-510k.jpg K902580 - EMIT(R) II BARBITURATE ASSAY K902580 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jul 1990. https://www.510kdatabase.net/k902698/ 1990-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k902698-affinity-prolactin-test-system-fda-510k.jpg K902698 - AFFINITY PROLACTIN TEST SYSTEM K902698 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jul 1990. https://www.510kdatabase.net/k901555/ 1990-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k901555-model-1730-neotrode-with-attached-fda-510k.jpg K901555 - MODEL 1730 NEOTRODE WITH ATTACHED LEADWIRE K901555 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jul 1990. https://www.510kdatabase.net/k901819/ 1990-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k901819-model-78834c-neonatal-pulse-oximeter-fda-510k.jpg K901819 - MODEL 78834C NEONATAL PULSE OXIMETER (SAO2) K901819 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Jul 1990. https://www.510kdatabase.net/k902080/ 1990-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k902080-red-dot-2269-infant-monitoring-electrode-fda-510k.jpg K902080 - RED DOT 2269 INFANT MONITORING ELECTRODE K902080 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: 3M Company. Cleared Jul 1990. https://www.510kdatabase.net/k895520/ 1990-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k895520-pagewriter-xli-m1700a-pagewriter-xl-fda-510k.jpg K895520 - PAGEWRITER XLI M1700A & PAGEWRITER XL M1701A K895520 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Jul 1990. https://www.510kdatabase.net/k897124/ 1990-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k897124-small-vessel-balloon-dilatation-catheter-fda-510k.jpg K897124 - SMALL VESSEL BALLOON DILATATION CATHETER K897124 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Jul 1990. https://www.510kdatabase.net/k901410/ 1990-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k901410-technicon-ra-2000tm-system-fda-510k.jpg K901410 - TECHNICON RA-2000(TM) SYSTEM K901410 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Jul 1990. https://www.510kdatabase.net/k902560/ 1990-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k902560-roche-cobas-ready-alkaline-phosphatase-fda-510k.jpg K902560 - ROCHE COBAS READY ALKALINE PHOSPHATASE REAGENT K902560 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jul 1990. https://www.510kdatabase.net/k902801/ 1990-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k902801-beckman-total-bilirubin-triggered-tb-t-fda-510k.jpg K902801 - BECKMAN TOTAL BILIRUBIN TRIGGERED (TB-T) KIT K902801 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jul 1990. https://www.510kdatabase.net/k895710/ 1990-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k895710-abbott-lifecare-4100-pca-infuser-fda-510k.jpg K895710 - ABBOTT LIFECARE 4100 PCA INFUSER K895710 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Jul 1990. https://www.510kdatabase.net/k901937/ 1990-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k901937-codman-suction-pattie-fda-510k.jpg K901937 - CODMAN SUCTION PATTIE K901937 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Jul 1990. https://www.510kdatabase.net/k902356/ 1990-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k902356-kodak-ektachem-clinical-chemistry-fda-510k.jpg K902356 - KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (SALI) K902356 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Jul 1990. https://www.510kdatabase.net/k896480/ 1990-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k896480-siemens-sonoline-ac-fda-510k.jpg K896480 - SIEMENS SONOLINE AC K896480 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 1990. https://www.510kdatabase.net/k902198/ 1990-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k902198-sarns-delphin-base-adapter-with-battery-fda-510k.jpg K902198 - SARNS DELPHIN BASE ADAPTER WITH BATTERY K902198 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: 3M Company. Cleared Jul 1990. https://www.510kdatabase.net/k895709/ 1990-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k895709-abbott-patient-controlled-analgesia-fda-510k.jpg K895709 - ABBOTT PATIENT CONTROLLED ANALGESIA (PCA) PUMP K895709 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Jul 1990. https://www.510kdatabase.net/k900742/ 1990-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k900742-rate-infuser-plus-fda-510k.jpg K900742 - RATE INFUSER PLUS K900742 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jul 1990. https://www.510kdatabase.net/k901500/ 1990-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k901500-chloride-reagent-for-the-au5000-fda-510k.jpg K901500 - CHLORIDE REAGENT FOR THE AU5000 CLINICAL LAB. ANA. K901500 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Jul 1990. https://www.510kdatabase.net/k902055/ 1990-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k902055-tenonetm-opiates-catalog-vkso14-fda-510k.jpg K902055 - TENONE(TM) OPIATES CATALOG: VKSO1,4 K902055 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jul 1990. https://www.510kdatabase.net/k902483/ 1990-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k902483-creatine-kinase-mb-test-mb-ds-item-67655-fda-510k.jpg K902483 - CREATINE KINASE-MB TEST (MB-DS) ITEM #67655 K902483 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jul 1990. https://www.510kdatabase.net/k902536/ 1990-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k902536-precinormr-im-normal-immunoassay-fda-510k.jpg K902536 - PRECINORM(R) IM NORMAL IMMUNOASSAY CONTROL SERUM K902536 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jul 1990. https://www.510kdatabase.net/k902573/ 1990-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k902573-precipathr-im-abnormal-immunassay-fda-510k.jpg K902573 - PRECIPATH(R) IM ABNORMAL IMMUNASSAY CONTROL SERUM K902573 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jul 1990. https://www.510kdatabase.net/k902578/ 1990-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k902578-emitr-ii-calibrator-a-level-1-level-2-fda-510k.jpg K902578 - EMIT(R) II CALIBRATOR A LEVEL 1 & LEVEL 2 K902578 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jul 1990. https://www.510kdatabase.net/k890736/ 1990-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k890736-tfv-2300-infusion-pump-fda-510k.jpg K890736 - TFV-2300 INFUSION PUMP K890736 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Jul 1990. https://www.510kdatabase.net/k901625/ 1990-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k901625-fogarty-arterial-embolectomy-ii-catheter-fda-510k.jpg K901625 - FOGARTY ARTERIAL EMBOLECTOMY II CATHETER K901625 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jul 1990. https://www.510kdatabase.net/k901730/ 1990-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k901730-ge-signa-advantage-fda-510k.jpg K901730 - GE SIGNA ADVANTAGE K901730 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Jul 1990. https://www.510kdatabase.net/k902228/ 1990-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k902228-modified-epicardial-array-fda-510k.jpg K902228 - MODIFIED EPICARDIAL ARRAY K902228 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jul 1990. https://www.510kdatabase.net/k895579/ 1990-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k895579-polysorb-synthetic-absorbable-suture-fda-510k.jpg K895579 - POLYSORB SYNTHETIC ABSORBABLE SUTURE K895579 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Jul 1990. https://www.510kdatabase.net/k900531/ 1990-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k900531-nonabsorbable-nylon-surgical-suture-fda-510k.jpg K900531 - NONABSORBABLE NYLON SURGICAL SUTURE* K900531 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Jul 1990. https://www.510kdatabase.net/k902243/ 1990-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k902243-technicon-immuno-itm-system-and-analytes-fda-510k.jpg K902243 - TECHNICON IMMUNO I(TM) SYSTEM AND ANALYTES K902243 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Jul 1990. https://www.510kdatabase.net/k884823/ 1990-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k884823-transpacr-ii-disposable-transducer-fda-510k.jpg K884823 - TRANSPAC(R) II, DISPOSABLE TRANSDUCER K884823 is a FDA 510(k) cleared neurology medical device. Manufacturer: Abbott Laboratories. Cleared Jul 1990. https://www.510kdatabase.net/k896930/ 1990-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k896930-cardiac-output-computer-model-com-3-fda-510k.jpg K896930 - CARDIAC OUTPUT COMPUTER, MODEL COM-3 K896930 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jul 1990. https://www.510kdatabase.net/k900771/ 1990-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k900771-attest-brand-rapid-readout-biological-fda-510k.jpg K900771 - ATTEST BRAND RAPID READOUT BIOLOGICAL INDICATOR K900771 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Jul 1990. https://www.510kdatabase.net/k901535/ 1990-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k901535-modified-medtronic-classix-model-8438-fda-510k.jpg K901535 - MODIFIED MEDTRONIC CLASSIX MODEL 8438 PULSE GENE. K901535 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jul 1990. https://www.510kdatabase.net/k901624/ 1990-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k901624-shiley-plexus-integral-reservoir-fda-510k.jpg K901624 - SHILEY PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY. K901624 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Jul 1990. https://www.510kdatabase.net/k902096/ 1990-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k902096-thromboplastin-with-calcium-fda-510k.jpg K902096 - THROMBOPLASTIN WITH CALCIUM K902096 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Chemical Co.. Cleared Jul 1990. https://www.510kdatabase.net/k902134/ 1990-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k902134-minix-minix-st-new-ic-l74-fda-510k.jpg K902134 - MINIX, MINIX ST, NEW IC: L74 K902134 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jul 1990. https://www.510kdatabase.net/k902294/ 1990-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k902294-accuscan-microbead-standards-fda-510k.jpg K902294 - ACCUSCAN MICROBEAD STANDARDS K902294 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Chemical Co.. Cleared Jul 1990. https://www.510kdatabase.net/k900480/ 1990-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k900480-m1350a-fetal-monitor-intrapartum-fda-510k.jpg K900480 - M1350A FETAL MONITOR (INTRAPARTUM) K900480 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Jul 1990. https://www.510kdatabase.net/k901023/ 1990-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k901023-gastrointestinal-tubes-and-accessories-fda-510k.jpg K901023 - GASTROINTESTINAL TUBES AND ACCESSORIES K901023 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medline Industries, Inc.. Cleared Jul 1990. https://www.510kdatabase.net/k901933/ 1990-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k901933-coat-a-count-pap-irma-catlog-1kpa1-1kpa2-fda-510k.jpg K901933 - COAT-A-COUNT PAP IRMA, CATLOG# 1KPA1, 1KPA2 K901933 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jun 1990. https://www.510kdatabase.net/k902136/ 1990-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k902136-kodak-surecelltm-hcg-urine-test-kit-fda-510k.jpg K902136 - KODAK SURECELL(TM) HCG-URINE TEST KIT K902136 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Jun 1990. https://www.510kdatabase.net/k902041/ 1990-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k902041-3m-luting-cement-paste-a-and-paste-b-fda-510k.jpg K902041 - 3M LUTING CEMENT - PASTE A AND PASTE B K902041 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Jun 1990. https://www.510kdatabase.net/k893769/ 1990-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k893769-lifecare-micro-pump-infusion-pump-fda-510k.jpg K893769 - LIFECARE MICRO PUMP (INFUSION PUMP) K893769 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1990. https://www.510kdatabase.net/k895867/ 1990-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k895867-pancretec-iv-model-5000-infuser-fda-510k.jpg K895867 - PANCRETEC I.V. MODEL 5000 INFUSER K895867 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1990. https://www.510kdatabase.net/k896225/ 1990-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k896225-cobas-ready-profile-2-reagent-strip-fda-510k.jpg K896225 - COBAS READY PROFILE 2 REAGENT STRIP K896225 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jun 1990. https://www.510kdatabase.net/k896960/ 1990-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k896960-intrauterine-insemination-catheters-fda-510k.jpg K896960 - INTRAUTERINE INSEMINATION CATHETERS K896960 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jun 1990. https://www.510kdatabase.net/k897097/ 1990-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k897097-cobas-ready-calibrator-kit-fda-510k.jpg K897097 - COBAS READY CALIBRATOR KIT K897097 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jun 1990. https://www.510kdatabase.net/k901391/ 1990-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k901391-datascope-ptca-percutaneous-catheter-fda-510k.jpg K901391 - DATASCOPE PTCA PERCUTANEOUS CATHETER INTRODUCER K901391 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Jun 1990. https://www.510kdatabase.net/k901404/ 1990-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k901404-nutrimix-macro-tpn-compounder-fda-510k.jpg K901404 - NUTRIMIX MACRO TPN COMPOUNDER K901404 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1990. https://www.510kdatabase.net/k901545/ 1990-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k901545-gca-9300-nuclear-tomography-system-fda-510k.jpg K901545 - GCA-9300 NUCLEAR TOMOGRAPHY SYSTEM K901545 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Jun 1990. https://www.510kdatabase.net/k902332/ 1990-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k902332-hall-modular-acetabular-reamer-system-fda-510k.jpg K902332 - HALL MODULAR ACETABULAR REAMER SYSTEM K902332 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jun 1990. https://www.510kdatabase.net/k895857/ 1990-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k895857-continuous-irrigation-resectoscope-fda-510k.jpg K895857 - CONTINUOUS IRRIGATION RESECTOSCOPE SYST/GYNECOLOGY K895857 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Jun 1990. https://www.510kdatabase.net/k896964/ 1990-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k896964-plasma-tfe-vascular-prosthesis-fda-510k.jpg K896964 - PLASMA TFE VASCULAR PROSTHESIS MODIFIED INSTRUC. K896964 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jun 1990. https://www.510kdatabase.net/k901347/ 1990-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k901347-datascope-slidewiretm-fda-510k.jpg K901347 - DATASCOPE SLIDEWIRE(TM) K901347 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Jun 1990. https://www.510kdatabase.net/k902484/ 1990-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k902484-beckman-kappa-light-chain-reagent-addl-fda-510k.jpg K902484 - BECKMAN KAPPA LIGHT CHAIN REAGENT (ADD'L CLAIMS) K902484 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jun 1990. https://www.510kdatabase.net/k902485/ 1990-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k902485-beckman-lambda-light-chain-reagent-fda-510k.jpg K902485 - BECKMAN LAMBDA LIGHT CHAIN REAGENT (ADD'L CLAIMS) K902485 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jun 1990. https://www.510kdatabase.net/k901475/ 1990-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k901475-clinical-assaystm-gammacoattm-m-125i-t4-fda-510k.jpg K901475 - CLINICAL ASSAYS(TM) GAMMACOAT(TM) M [125I] T4 K901475 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jun 1990. https://www.510kdatabase.net/k901934/ 1990-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k901934-kodak-surecelltm-chlamydia-control-fda-510k.jpg K901934 - KODAK SURECELL(TM) CHLAMYDIA CONTROL FLUID SET K901934 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Eastman Kodak Company. Cleared Jun 1990. https://www.510kdatabase.net/k896712/ 1990-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k896712-pharmaseal-epidural-catheter-fda-510k.jpg K896712 - PHARMASEAL EPIDURAL CATHETER K896712 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jun 1990. https://www.510kdatabase.net/k897194/ 1990-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k897194-pharmaseal-epidural-catheter-fda-510k.jpg K897194 - PHARMASEAL EPIDURAL CATHETER & CONTINUOUS EPIDURAL K897194 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jun 1990. https://www.510kdatabase.net/k902380/ 1990-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k902380-triflex-orthopedic-sterile-surgeons-fda-510k.jpg K902380 - TRIFLEX ORTHOPEDIC STERILE SURGEON'S GLOVE K902380 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jun 1990. https://www.510kdatabase.net/k900546/ 1990-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k900546-bartels-neisseria-gonorrhoeae-direct-fda-510k.jpg K900546 - BARTELS NEISSERIA GONORRHOEAE DIRECT FLUORESCENT K900546 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jun 1990. https://www.510kdatabase.net/k901414/ 1990-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k901414-columnmate-automated-column-system-fda-510k.jpg K901414 - COLUMNMATE (AUTOMATED COLUMN SYSTEM) 1580, 1581 K901414 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Jun 1990. https://www.510kdatabase.net/k902083/ 1990-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k902083-chrom-trol-cat-no-5300-w-new-analyte-fda-510k.jpg K902083 - CHROM-TROL CAT. NO. 5300 W/ NEW ANALYTE K902083 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Jun 1990. https://www.510kdatabase.net/k900718/ 1990-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k900718-rotag-fructosamine-glycated-protein-fda-510k.jpg K900718 - ROTAG FRUCTOSAMINE (GLYCATED PROTEIN) ASSAY K900718 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jun 1990. https://www.510kdatabase.net/k901463/ 1990-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k901463-reptm-spe-plus-16-ponceau-s-and-amido-fda-510k.jpg K901463 - REP(TM) SPE PLUS-16 (PONCEAU S) AND (AMIDO) K901463 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Jun 1990. https://www.510kdatabase.net/k901673/ 1990-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k901673-prolactin-lactogen-test-system-fda-510k.jpg K901673 - PROLACTIN (LACTOGEN) TEST SYSTEM K901673 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jun 1990. https://www.510kdatabase.net/k901858/ 1990-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k901858-modified-labeling-for-aca-lipase-fda-510k.jpg K901858 - MODIFIED LABELING FOR ACA LIPASE ANALYTICAL TEST K901858 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Jun 1990. https://www.510kdatabase.net/k901249/ 1990-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k901249-plexus-35tm-pediatric-hollow-fiber-fda-510k.jpg K901249 - PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATOR K901249 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Jun 1990. https://www.510kdatabase.net/k901250/ 1990-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k901250-plexus-2tm-infant-hollow-fiber-fda-510k.jpg K901250 - PLEXUS 2(TM) INFANT HOLLOW FIBER OXYGENATOR K901250 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Jun 1990. https://www.510kdatabase.net/k761234/ 1990-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k761234-behring-laser-nephelometer-fda-510k.jpg K761234 - BEHRING LASER NEPHELOMETER K761234 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Jun 1990. https://www.510kdatabase.net/k901573/ 1990-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k901573-emit-dau-low-and-medium-calibrators-b-fda-510k.jpg K901573 - EMIT D.A.U. LOW AND MEDIUM CALIBRATORS B K901573 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jun 1990. https://www.510kdatabase.net/k901805/ 1990-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k901805-repr-immunofix-fda-510k.jpg K901805 - REP(R) IMMUNOFIX K901805 is a FDA 510(k) cleared immunology medical device. Manufacturer: Helena Laboratories. Cleared Jun 1990. https://www.510kdatabase.net/k902123/ 1990-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k902123-systematetm-direct-bilirubin-catalog-fda-510k.jpg K902123 - SYSTEMATE(TM) DIRECT BILIRUBIN CATALOG NO. 65406 K902123 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jun 1990. https://www.510kdatabase.net/k902037/ 1990-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k902037-pathodx-pyr-kit-fda-510k.jpg K902037 - PATHODX PYR KIT K902037 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jun 1990. https://www.510kdatabase.net/k902154/ 1990-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k902154-na-latex-myoglobin-test-fda-510k.jpg K902154 - NA LATEX MYOGLOBIN TEST K902154 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Jun 1990. https://www.510kdatabase.net/k900200/ 1990-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k900200-cook-stereotaxic-guide-fda-510k.jpg K900200 - COOK STEREOTAXIC GUIDE K900200 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cook, Inc.. Cleared May 1990. https://www.510kdatabase.net/k901216/ 1990-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k901216-enzymun-testr-digoxin-fda-510k.jpg K901216 - ENZYMUN TEST(R) DIGOXIN K901216 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared May 1990. https://www.510kdatabase.net/k900719/ 1990-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k900719-rotag-controls-fda-510k.jpg K900719 - ROTAG CONTROLS K900719 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared May 1990. https://www.510kdatabase.net/k901018/ 1990-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k901018-modified-transluminal-balloon-fda-510k.jpg K901018 - MODIFIED TRANSLUMINAL BALLOON DILATATION CATHETERS K901018 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared May 1990. https://www.510kdatabase.net/k901617/ 1990-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k901617-endoscopic-carpal-tunnel-release-fda-510k.jpg K901617 - ENDOSCOPIC CARPAL TUNNEL RELEASE SYSTEM (ECTR) K901617 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared May 1990. https://www.510kdatabase.net/k901380/ 1990-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k901380-cascade-480tm-automated-coagulation-fda-510k.jpg K901380 - CASCADE 480(TM) AUTOMATED COAGULATION ANALY. 1430 K901380 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared May 1990. https://www.510kdatabase.net/k901143/ 1990-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k901143-rep-hemoglobin-ief-kits-cat-no-3250-fda-510k.jpg K901143 - REP HEMOGLOBIN IEF KITS (CAT. NO. 3250) K901143 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared May 1990. https://www.510kdatabase.net/k901758/ 1990-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k901758-roche-reagent-for-magnesium-fda-510k.jpg K901758 - ROCHE REAGENT FOR MAGNESIUM K901758 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared May 1990. https://www.510kdatabase.net/k901818/ 1990-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k901818-addl-software-version-d2-for-magnetom-fda-510k.jpg K901818 - ADD'L SOFTWARE VERSION D2 FOR MAGNETOM 42 AND 63 K901818 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 1990. https://www.510kdatabase.net/k901452/ 1990-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k901452-uscir-accesstm-introducer-set-fda-510k.jpg K901452 - USCI(R) ACCESS(TM) INTRODUCER SET K901452 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 1990. https://www.510kdatabase.net/k900908/ 1990-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k900908-controlled-distention-irrigation-fda-510k.jpg K900908 - CONTROLLED DISTENTION IRRIGATION SYSTEM CDIS 200 K900908 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Zimmer, Inc.. Cleared May 1990. https://www.510kdatabase.net/k902038/ 1990-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k902038-patho-dx-strep-d-fda-510k.jpg K902038 - PATHO DX STREP D K902038 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared May 1990. https://www.510kdatabase.net/k900909/ 1990-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k900909-in-line-vial-connection-site-fda-510k.jpg K900909 - IN-LINE VIAL CONNECTION SITE K900909 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared May 1990. https://www.510kdatabase.net/k901364/ 1990-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k901364-hgp-ii-total-hip-femeral-stem-fda-510k.jpg K901364 - HGP II TOTAL HIP FEMERAL STEM K901364 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared May 1990. https://www.510kdatabase.net/k900813/ 1990-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k900813-bard-short-rigid-ureteroscope-fda-510k.jpg K900813 - BARD SHORT RIGID URETEROSCOPE K900813 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 1990. https://www.510kdatabase.net/k901568/ 1990-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k901568-mileniatm-cannabinoids-fda-510k.jpg K901568 - MILENIA(TM) CANNABINOIDS K901568 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared May 1990. https://www.510kdatabase.net/k901577/ 1990-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k901577-mileniatm-opiates-fda-510k.jpg K901577 - MILENIA(TM) OPIATES K901577 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared May 1990. https://www.510kdatabase.net/k896340/ 1990-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k896340-biomerr-f-composite-luting-cement-fda-510k.jpg K896340 - BIOMER(R) F COMPOSITE LUTING CEMENT K896340 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared May 1990. https://www.510kdatabase.net/k896410/ 1990-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k896410-cellognost-syphilis-h-fda-510k.jpg K896410 - CELLOGNOST SYPHILIS H K896410 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared May 1990. https://www.510kdatabase.net/k900802/ 1990-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k900802-anti-human-leu-3a-cd4-fitc-fda-510k.jpg K900802 - ANTI-HUMAN LEU-3A (CD4) FITC K900802 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared May 1990. https://www.510kdatabase.net/k900883/ 1990-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k900883-enzymun-testr-ft4-free-thyroxine-fda-510k.jpg K900883 - ENZYMUN TEST(R) FT4 (FREE THYROXINE) K900883 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared May 1990. https://www.510kdatabase.net/k900887/ 1990-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k900887-abbott-spectrum-automated-clinical-fda-510k.jpg K900887 - ABBOTT SPECTRUM AUTOMATED CLINICAL CHEM. ANALYZER K900887 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared May 1990. https://www.510kdatabase.net/k900935/ 1990-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k900935-du-pont-linx-laser-imager-wthe-linx-fda-510k.jpg K900935 - DU PONT LINX LASER IMAGER W/THE LINX NETWORKING K900935 is a FDA 510(k) cleared radiology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared May 1990. https://www.510kdatabase.net/k901017/ 1990-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k901017-du-pont-analyst-analytical-test-fda-510k.jpg K901017 - DU PONT ANALYST ANALYTICAL TEST ROTOR:CHEM-14,CALI K901017 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared May 1990. https://www.510kdatabase.net/k901124/ 1990-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k901124-chem-i-clinical-analyzer-urine-magnesium-fda-510k.jpg K901124 - CHEM I CLINICAL ANALYZER URINE MAGNESIUM K901124 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared May 1990. https://www.510kdatabase.net/k900713/ 1990-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k900713-herptran-concentrate-fda-510k.jpg K900713 - HERPTRAN CONCENTRATE K900713 is a FDA 510(k) cleared microbiology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared May 1990. https://www.510kdatabase.net/k901274/ 1990-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k901274-testpack-plus-strep-a-fda-510k.jpg K901274 - TESTPACK PLUS STREP A K901274 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared May 1990. https://www.510kdatabase.net/k897174/ 1990-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k897174-olympustm-total-bilirubin-fda-510k.jpg K897174 - OLYMPUS(TM) TOTAL BILIRUBIN K897174 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared May 1990. https://www.510kdatabase.net/k900797/ 1990-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k900797-stockert-shiley-dual-pressure-control-fda-510k.jpg K900797 - STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR K900797 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared May 1990. https://www.510kdatabase.net/k900879/ 1990-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k900879-soft-wedgetm-syringe-fda-510k.jpg K900879 - SOFT-WEDGE(TM) SYRINGE K900879 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared May 1990. https://www.510kdatabase.net/k901123/ 1990-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k901123-chem-1-clinical-analyzer-urine-urea-fda-510k.jpg K901123 - CHEM 1 CLINICAL ANALYZER URINE UREA NITROGEN K901123 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared May 1990. https://www.510kdatabase.net/k895117/ 1990-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k895117-hto-compressing-staple-fda-510k.jpg K895117 - HTO COMPRESSING STAPLE K895117 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared May 1990. https://www.510kdatabase.net/k900815/ 1990-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k900815-sarns-9000-perfusion-system-walert-fda-510k.jpg K900815 - SARNS 9000 PERFUSION SYSTEM W/ALERT ONLY LEVEL K900815 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: 3M Company. Cleared May 1990. https://www.510kdatabase.net/k900835/ 1990-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k900835-modified-perm-cath-fda-510k.jpg K900835 - MODIFIED PERM-CATH K900835 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quinton, Inc.. Cleared May 1990. https://www.510kdatabase.net/k901358/ 1990-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k901358-bard-biopotential-amplifier-ii-fda-510k.jpg K901358 - BARD BIOPOTENTIAL AMPLIFIER II K901358 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 1990. https://www.510kdatabase.net/k896755/ 1990-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k896755-aloka-680-diagnostic-ultrasound-fda-510k.jpg K896755 - ALOKA 680 DIAGNOSTIC ULTRASOUND SCANNING SYSTEM K896755 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared May 1990. https://www.510kdatabase.net/k901087/ 1990-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k901087-modified-profile-ii-acetabular-cup-fda-510k.jpg K901087 - MODIFIED PROFILE II ACETABULAR CUP PROSTHESIS K901087 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared May 1990. https://www.510kdatabase.net/k901405/ 1990-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k901405-digiformer-hr-dfp-50a-fda-510k.jpg K901405 - DIGIFORMER HR DFP-50A K901405 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared May 1990. https://www.510kdatabase.net/k900832/ 1990-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k900832-modified-depuy-acetabular-cup-system-fda-510k.jpg K900832 - MODIFIED DEPUY ACETABULAR CUP SYSTEM* HIP ACETA. K900832 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared May 1990. https://www.510kdatabase.net/k901229/ 1990-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k901229-chem-1-clinical-analyzer-method-urine-fda-510k.jpg K901229 - CHEM 1 CLINICAL ANALYZER (METHOD URINE CREATININE) K901229 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared May 1990. https://www.510kdatabase.net/k900543/ 1990-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k900543-chlamydiazyme-diagnostic-kit-fda-510k.jpg K900543 - CHLAMYDIAZYME DIAGNOSTIC KIT K900543 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared May 1990. https://www.510kdatabase.net/k900984/ 1990-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k900984-modified-unipolar-implant-pacing-leads-fda-510k.jpg K900984 - MODIFIED UNIPOLAR IMPLANT. PACING LEADS W/IS-1 K900984 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared May 1990. https://www.510kdatabase.net/k901859/ 1990-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k901859-coat-a-count-total-ige-irma-catalog-fda-510k.jpg K901859 - COAT-A-COUNT TOTAL IGE IRMA, CATALOG #IKIE1, IKIE2 K901859 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared May 1990. https://www.510kdatabase.net/k896688/ 1990-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k896688-urine-collector-leg-bag-fda-510k.jpg K896688 - URINE COLLECTOR LEG BAG K896688 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medline Industries, Inc.. Cleared May 1990. https://www.510kdatabase.net/k896695/ 1990-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k896695-dyna-flo-urinary-drainage-bag-fda-510k.jpg K896695 - DYNA-FLO URINARY DRAINAGE BAG K896695 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medline Industries, Inc.. Cleared May 1990. https://www.510kdatabase.net/k896853/ 1990-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k896853-precision-osteolock-femoral-comp-fda-510k.jpg K896853 - PRECISION OSTEOLOCK FEMORAL COMP. TITANIUM PLASMA K896853 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared May 1990. https://www.510kdatabase.net/k900485/ 1990-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k900485-enzymun-testr-cortisol-fda-510k.jpg K900485 - ENZYMUN TEST(R) CORTISOL K900485 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared May 1990. https://www.510kdatabase.net/k900852/ 1990-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k900852-magnet-retrieval-catheter-fda-510k.jpg K900852 - MAGNET RETRIEVAL CATHETER K900852 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook, Inc.. Cleared May 1990. https://www.510kdatabase.net/k901270/ 1990-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k901270-lyphochek-urine-toxicology-control-fda-510k.jpg K901270 - LYPHOCHEK URINE TOXICOLOGY CONTROL - SCREEN K901270 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bio-Rad. Cleared May 1990. https://www.510kdatabase.net/k901297/ 1990-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k901297-exactech-porous-coat-total-hip-prost-fda-510k.jpg K901297 - EXACTECH POROUS COAT TOTAL HIP PROST FEM STEM COMP K901297 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared May 1990. https://www.510kdatabase.net/k901325/ 1990-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k901325-thromboplastinc-plus-fda-510k.jpg K901325 - THROMBOPLASTIN.C PLUS K901325 is a FDA 510(k) cleared hematology medical device. Manufacturer: Baxter Healthcare Corp. Cleared May 1990. https://www.510kdatabase.net/k901596/ 1990-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k901596-nova-litetm-ana-ksl-fda-510k.jpg K901596 - NOVA LITE(TM) ANA KSL K901596 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared May 1990. https://www.510kdatabase.net/k901759/ 1990-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k901759-cobas-fp-reagents-for-vancomycin-fda-510k.jpg K901759 - COBAS-FP REAGENTS FOR VANCOMYCIN K901759 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared May 1990. https://www.510kdatabase.net/k901807/ 1990-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k901807-olympus-inorganic-phosphorus-2-reagent-fda-510k.jpg K901807 - OLYMPUS INORGANIC PHOSPHORUS (2-REAGENT MODIFICA.) K901807 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared May 1990. https://www.510kdatabase.net/k901778/ 1990-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k901778-3m-heat-comfort-portable-self-heating-fda-510k.jpg K901778 - 3M HEAT COMFORT PORTABLE SELF-HEATING PAD K901778 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: 3M Company. Cleared May 1990. https://www.510kdatabase.net/k890061/ 1990-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k890061-model-3586-resume-lead-fda-510k.jpg K890061 - MODEL 3586 RESUME LEAD K890061 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Apr 1990. https://www.510kdatabase.net/k894098/ 1990-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k894098-synthes-external-fixation-bone-clip-fda-510k.jpg K894098 - SYNTHES EXTERNAL FIXATION BONE CLIP K894098 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Apr 1990. https://www.510kdatabase.net/k900622/ 1990-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k900622-modified-model-5401b-test-cable-fda-510k.jpg K900622 - MODIFIED MODEL 5401B TEST CABLE K900622 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Apr 1990. https://www.510kdatabase.net/k900717/ 1990-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k900717-technicon-testpointtm-ligand-control-fda-510k.jpg K900717 - TECHNICON TESTPOINT(TM) LIGAND CONTROL K900717 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Apr 1990. https://www.510kdatabase.net/k900943/ 1990-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k900943-modified-technicon-dpa-1tm-system-fda-510k.jpg K900943 - MODIFIED TECHNICON DPA-1(TM) SYSTEM K900943 is a FDA 510(k) cleared immunology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Apr 1990. https://www.510kdatabase.net/k901276/ 1990-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k901276-hemacon-doatm-drugs-of-abuse-whole-fda-510k.jpg K901276 - HEMACON-DOA(TM) DRUGS OF ABUSE WHOLE BLOOD CONTROL K901276 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Apr 1990. https://www.510kdatabase.net/k901595/ 1990-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k901595-nova-litetm-ana-mk-fda-510k.jpg K901595 - NOVA LITE(TM) ANA MK K901595 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Apr 1990. https://www.510kdatabase.net/k901675/ 1990-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k901675-apolipoprotein-a-i-apo-a-i-fda-510k.jpg K901675 - APOLIPOPROTEIN A-I (APO A-I) K901675 is a FDA 510(k) cleared immunology medical device. Manufacturer: Sigma Chemical Co.. Cleared Apr 1990. https://www.510kdatabase.net/k900940/ 1990-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k900940-tdx-phencyclidine-ii-assay-fda-510k.jpg K900940 - TDX PHENCYCLIDINE II ASSAY K900940 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1990. https://www.510kdatabase.net/k901298/ 1990-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k901298-creatinine-reagent-for-au5000-clin-lab-fda-510k.jpg K901298 - CREATININE REAGENT FOR AU5000 CLIN LAB ANAL-MODIFY K901298 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Apr 1990. https://www.510kdatabase.net/k901693/ 1990-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k901693-technicon-chem-1-clinical-analyzer-for-fda-510k.jpg K901693 - TECHNICON CHEM 1 CLINICAL ANALYZER FOR URINE URIC K901693 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Apr 1990. https://www.510kdatabase.net/k895180/ 1990-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k895180-usci-7f-large-lumen-guiding-catheter-fda-510k.jpg K895180 - USCI 7F LARGE LUMEN GUIDING CATHETER K895180 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 1990. https://www.510kdatabase.net/k895775/ 1990-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k895775-cf-indicator-model-9800-sweat-test-fda-510k.jpg K895775 - CF INDICATOR MODEL 9800 SWEAT TEST SYSTEM K895775 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Medtronic Vascular. Cleared Apr 1990. https://www.510kdatabase.net/k896341/ 1990-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k896341-fluroshieldtm-visible-light-cure-pit-fda-510k.jpg K896341 - FLUROSHIELD(TM) VISIBLE LIGHT CURE PIT & FISSURE K896341 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Apr 1990. https://www.510kdatabase.net/k900548/ 1990-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k900548-shiley-phonation-valve-fda-510k.jpg K900548 - SHILEY PHONATION VALVE K900548 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shiley, Inc.. Cleared Apr 1990. https://www.510kdatabase.net/k900926/ 1990-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k900926-trochanter-cable-grip-system-addl-fda-510k.jpg K900926 - TROCHANTER CABLE GRIP SYSTEM (ADD'L INDICATIONS) K900926 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Apr 1990. https://www.510kdatabase.net/k894664/ 1990-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k894664-capiox-hardshell-venous-reservoir-fda-510k.jpg K894664 - CAPIOX HARDSHELL VENOUS RESERVOIR K894664 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Apr 1990. https://www.510kdatabase.net/k900627/ 1990-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k900627-model-5866-34-lead-adaptor-kit-fda-510k.jpg K900627 - MODEL 5866-34 LEAD ADAPTOR KIT K900627 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Apr 1990. https://www.510kdatabase.net/k900640/ 1990-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k900640-modified-mp-4-cardioplegia-delivery-fda-510k.jpg K900640 - MODIFIED MP-4 CARDIOPLEGIA DELIVERY SYSTEM W/CONDU K900640 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: 3M Company. Cleared Apr 1990. https://www.510kdatabase.net/k900995/ 1990-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k900995-emit-dau-amphetamine-class-assay-fda-510k.jpg K900995 - EMIT D.A.U. AMPHETAMINE CLASS ASSAY K900995 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Apr 1990. https://www.510kdatabase.net/k900281/ 1990-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k900281-series-3001-iabp-fda-510k.jpg K900281 - SERIES 3001 IABP K900281 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Apr 1990. https://www.510kdatabase.net/k901034/ 1990-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k901034-models-wep-8410a-and-wep-8420a-fda-510k.jpg K901034 - MODELS WEP-8410A AND WEP-8420A TELEMETRY CENTRAL K901034 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Apr 1990. https://www.510kdatabase.net/k901038/ 1990-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k901038-sps-550-ips-integrated-patient-station-fda-510k.jpg K901038 - SPS 550-IPS (INTEGRATED PATIENT STATION) K901038 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Apr 1990. https://www.510kdatabase.net/k901226/ 1990-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k901226-chem-1-clinical-analyzer-method-urine-fda-510k.jpg K901226 - CHEM 1 CLINICAL ANALYZER (METHOD URINE CALCIUM) K901226 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Apr 1990. https://www.510kdatabase.net/k901578/ 1990-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k901578-coat-a-count-prolactin-irma-ikpr1-ikpr2-fda-510k.jpg K901578 - COAT-A-COUNT PROLACTIN IRMA #:IKPR1, IKPR2 K901578 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Apr 1990. https://www.510kdatabase.net/k900327/ 1990-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k900327-imx-hcg-list-03a63-fda-510k.jpg K900327 - IMX HCG (LIST #03A63) K900327 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1990. https://www.510kdatabase.net/k900438/ 1990-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k900438-mc2p-acetabular-component-fda-510k.jpg K900438 - MC2P ACETABULAR COMPONENT K900438 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Apr 1990. https://www.510kdatabase.net/k900584/ 1990-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k900584-alta-lag-screw-and-compression-screw-fda-510k.jpg K900584 - ALTA LAG SCREW AND COMPRESSION SCREW K900584 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Apr 1990. https://www.510kdatabase.net/k900229/ 1990-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k900229-bard-conformacath-foley-catheter-fda-510k.jpg K900229 - BARD CONFORMACATH FOLEY CATHETER K900229 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 1990. https://www.510kdatabase.net/k900069/ 1990-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k900069-modified-pgl-absorbable-staple-fda-510k.jpg K900069 - MODIFIED PGL ABSORBABLE STAPLE* K900069 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Apr 1990. https://www.510kdatabase.net/k900393/ 1990-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k900393-opaque-porcelain-fda-510k.jpg K900393 - OPAQUE PORCELAIN K900393 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Apr 1990. https://www.510kdatabase.net/k900870/ 1990-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k900870-pathodx-chlamydia-trachomatis-direct-fda-510k.jpg K900870 - PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TEST K900870 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Apr 1990. https://www.510kdatabase.net/k901003/ 1990-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k901003-boehringer-mannheimhitachi-747-fda-510k.jpg K901003 - BOEHRINGER MANNHEIM/HITACHI 747 CHEMISTRY ANALYZER K901003 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Apr 1990. https://www.510kdatabase.net/k901083/ 1990-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k901083-emdstm-cerebrospinal-fluid-protein-fda-510k.jpg K901083 - EMDS(TM) CEREBROSPINAL FLUID PROTEIN, #67668/95 K901083 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Apr 1990. https://www.510kdatabase.net/k901346/ 1990-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k901346-es-300-immunoassay-system-fda-510k.jpg K901346 - ES 300 IMMUNOASSAY SYSTEM K901346 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Apr 1990. https://www.510kdatabase.net/k901137/ 1990-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k901137-chem-1-clinical-analyzer-urine-fda-510k.jpg K901137 - CHEM 1 CLINICAL ANALYZER (URINE INORGANIC PHOSPHO) K901137 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Apr 1990. https://www.510kdatabase.net/k900245/ 1990-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k900245-du-pont-vistar-immunoassay-system-fda-510k.jpg K900245 - DU PONT VISTA(R) IMMUNOASSAY SYSTEM K900245 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Apr 1990. https://www.510kdatabase.net/k900277/ 1990-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k900277-enzymun-testr-tsh-s-fda-510k.jpg K900277 - ENZYMUN TEST(R) TSH-S K900277 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Apr 1990. https://www.510kdatabase.net/k901271/ 1990-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k901271-lyphochek-urine-toxicology-control-fda-510k.jpg K901271 - LYPHOCHEK URINE TOXICOLOGY CONTROL - CONFIRM K901271 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bio-Rad. Cleared Apr 1990. https://www.510kdatabase.net/k900032/ 1990-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k900032-model-m1175am1176a-with-st-segment-fda-510k.jpg K900032 - MODEL M1175A/M1176A WITH ST SEGMENT MONITORING K900032 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Apr 1990. https://www.510kdatabase.net/k900186/ 1990-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k900186-bonchek-shiley-cardiac-jacket-fda-510k.jpg K900186 - BONCHEK-SHILEY CARDIAC JACKET W/RECIRCULATION SET K900186 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Apr 1990. https://www.510kdatabase.net/k900302/ 1990-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k900302-umbilical-cord-blood-sampling-kit-fda-510k.jpg K900302 - UMBILICAL CORD BLOOD SAMPLING KIT K900302 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Apr 1990. https://www.510kdatabase.net/k900507/ 1990-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k900507-disposable-screw-type-prophy-brush-fda-510k.jpg K900507 - DISPOSABLE SCREW TYPE PROPHY BRUSH K900507 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Apr 1990. https://www.510kdatabase.net/k900699/ 1990-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k900699-flo-gard-6300-blood-pumping-indication-fda-510k.jpg K900699 - FLO-GARD 6300 BLOOD PUMPING INDICATION K900699 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Apr 1990. https://www.510kdatabase.net/k900753/ 1990-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k900753-shiley-vein-irrigation-cannula-beveled-fda-510k.jpg K900753 - SHILEY VEIN IRRIGATION CANNULA (BEVELED & BLUNT) K900753 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Apr 1990. https://www.510kdatabase.net/k901107/ 1990-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k901107-modified-auto-suture-purstring-disp-fda-510k.jpg K901107 - MODIFIED AUTO SUTURE PURSTRING DISP. AUTOMATIC K901107 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Apr 1990. https://www.510kdatabase.net/k901141/ 1990-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k901141-paramax-520-paramax-720-and-paramax-fda-510k.jpg K901141 - PARAMAX 520, PARAMAX 720 AND PARAMAX 720ZX K901141 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Baxter Healthcare Corp. Cleared Apr 1990. https://www.510kdatabase.net/k895542/ 1990-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k895542-sonicathtm-5-f-fda-510k.jpg K895542 - SONICATH(TM) 5 F K895542 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Apr 1990. https://www.510kdatabase.net/k900093/ 1990-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k900093-disposa-shieldtm-infection-control-fda-510k.jpg K900093 - DISPOSA-SHIELD(TM) INFECTION CONTROL BARRIER K900093 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Apr 1990. https://www.510kdatabase.net/k900123/ 1990-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k900123-auto-suture-surgiport-spiral-sleeve-fda-510k.jpg K900123 - AUTO SUTURE SURGIPORT SPIRAL SLEEVE K900123 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Apr 1990. https://www.510kdatabase.net/k897147/ 1990-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k897147-sigma-procedure-no-735-fda-510k.jpg K897147 - SIGMA PROCEDURE NO. 735 K897147 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Apr 1990. https://www.510kdatabase.net/k900204/ 1990-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k900204-avi-model-840-dual-channel-infusion-pump-fda-510k.jpg K900204 - AVI MODEL 840 DUAL CHANNEL INFUSION PUMP K900204 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Apr 1990. https://www.510kdatabase.net/k900776/ 1990-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k900776-novapath-microplate-reader-fda-510k.jpg K900776 - NOVAPATH MICROPLATE READER K900776 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Apr 1990. https://www.510kdatabase.net/k900779/ 1990-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k900779-enzymun-testr-lh-fda-510k.jpg K900779 - ENZYMUN TEST(R) LH K900779 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Apr 1990. https://www.510kdatabase.net/k900905/ 1990-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k900905-technicon-axon-system-reagent-methods-fda-510k.jpg K900905 - TECHNICON AXON SYSTEM REAGENT METHODS K900905 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Apr 1990. https://www.510kdatabase.net/k901135/ 1990-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k901135-enzymun-testr-insulin-fda-510k.jpg K901135 - ENZYMUN TEST(R) INSULIN K901135 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Apr 1990. https://www.510kdatabase.net/k895487/ 1990-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k895487-temporary-dental-cement-fda-510k.jpg K895487 - TEMPORARY DENTAL CEMENT K895487 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Apr 1990. https://www.510kdatabase.net/k900078/ 1990-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k900078-simultest-imk-plustm-fda-510k.jpg K900078 - SIMULTEST IMK PLUS(TM) K900078 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1990. https://www.510kdatabase.net/k897183/ 1990-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k897183-synchron-el-isetm-electrolyte-systems-fda-510k.jpg K897183 - SYNCHRON EL-ISE(TM) ELECTROLYTE SYSTEMS K897183 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Mar 1990. https://www.510kdatabase.net/k900121/ 1990-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k900121-roche-reagent-for-ldh-fda-510k.jpg K900121 - ROCHE REAGENT FOR LDH K900121 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Mar 1990. https://www.510kdatabase.net/k900695/ 1990-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k900695-enzymun-testr-prolactin-fda-510k.jpg K900695 - ENZYMUN TEST(R) PROLACTIN K900695 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Mar 1990. https://www.510kdatabase.net/k901086/ 1990-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k901086-enzymun-testr-t4-total-thyroxine-fda-510k.jpg K901086 - ENZYMUN TEST(R) T4 (TOTAL THYROXINE) K901086 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Mar 1990. https://www.510kdatabase.net/k896391/ 1990-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k896391-bardangiomed-stents-fda-510k.jpg K896391 - BARD/ANGIOMED STENTS K896391 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 1990. https://www.510kdatabase.net/k897015/ 1990-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k897015-glucometer-gx-blood-glucose-meter-fda-510k.jpg K897015 - GLUCOMETER GX BLOOD GLUCOSE METER K897015 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Mar 1990. https://www.510kdatabase.net/k900850/ 1990-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k900850-emds-cholesterol-cho-item-numbers-65410-fda-510k.jpg K900850 - EMDS CHOLESTEROL (CHO), ITEM NUMBERS 65410 K900850 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Mar 1990. https://www.510kdatabase.net/k901045/ 1990-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k901045-hcg-solid-phase-component-system-fda-510k.jpg K901045 - HCG SOLID PHASE COMPONENT SYSTEM K901045 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1990. https://www.510kdatabase.net/k901122/ 1990-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k901122-technicon-chem-1-clinical-analyzer-fda-510k.jpg K901122 - TECHNICON CHEM 1 CLINICAL ANALYZER URINE GLUCOSE K901122 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Mar 1990. https://www.510kdatabase.net/k894784/ 1990-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k894784-modified-shiley-femoral-venous-cannula-fda-510k.jpg K894784 - MODIFIED SHILEY FEMORAL VENOUS CANNULA K894784 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Mar 1990. https://www.510kdatabase.net/k896308/ 1990-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k896308-cordis-shuttle-catheter-fda-510k.jpg K896308 - CORDIS SHUTTLE CATHETER K896308 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Mar 1990. https://www.510kdatabase.net/k900113/ 1990-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k900113-respironics-remstartm-sleepeasy-fda-510k.jpg K900113 - RESPIRONICS' REMSTAR(TM) SLEEPEASY K900113 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Mar 1990. https://www.510kdatabase.net/k900339/ 1990-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k900339-hand-held-intracardiac-suckers-fda-510k.jpg K900339 - HAND-HELD INTRACARDIAC SUCKERS W/ERGONOMIC HANDLES K900339 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Mar 1990. https://www.510kdatabase.net/k900601/ 1990-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k900601-sarns-delphin-base-adapter-with-mini-fda-510k.jpg K900601 - SARNS DELPHIN BASE ADAPTER WITH MINI-BATTERY K900601 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: 3M Company. Cleared Mar 1990. https://www.510kdatabase.net/k900057/ 1990-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k900057-lifecarer-175-infuser-fda-510k.jpg K900057 - LIFECARE(R) 175 INFUSER K900057 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1990. https://www.510kdatabase.net/k896670/ 1990-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k896670-tip-topr-dispenser-caps-fda-510k.jpg K896670 - TIP TOP(R) DISPENSER CAPS K896670 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Mar 1990. https://www.510kdatabase.net/k900806/ 1990-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k900806-stratusr-ck-mb-fluorometric-enzyme-fda-510k.jpg K900806 - STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY K900806 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 1990. https://www.510kdatabase.net/k900889/ 1990-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k900889-magnetic-resonance-diagnostic-device-fda-510k.jpg K900889 - MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES K900889 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 1990. https://www.510kdatabase.net/k901104/ 1990-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k901104-paramax-aspartate-aminotransferase-fda-510k.jpg K901104 - PARAMAX ASPARTATE AMINOTRANSFERASE REAGENT K901104 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 1990. https://www.510kdatabase.net/k901105/ 1990-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k901105-paramax-alanine-aminotransferase-reagent-fda-510k.jpg K901105 - PARAMAX ALANINE AMINOTRANSFERASE REAGENT K901105 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 1990. https://www.510kdatabase.net/k900836/ 1990-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k900836-osteonics-ecsi-hip-stem-series-fda-510k.jpg K900836 - OSTEONICS ECSI HIP STEM SERIES K900836 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Mar 1990. https://www.510kdatabase.net/k900122/ 1990-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k900122-auto-suture-latchless-absorbable-fda-510k.jpg K900122 - AUTO SUTURE LATCHLESS ABSORBABLE HEMOSTATIC CLIP* K900122 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Mar 1990. https://www.510kdatabase.net/k897176/ 1990-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k897176-systematetm-total-bilirubin-catalog-no-fda-510k.jpg K897176 - SYSTEMATE(TM) TOTAL BILIRUBIN CATALOG NO. 654XX K897176 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Mar 1990. https://www.510kdatabase.net/k900086/ 1990-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k900086-hemorrhoidal-ligator-with-suction-fda-510k.jpg K900086 - HEMORRHOIDAL LIGATOR WITH SUCTION K900086 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 1990. https://www.510kdatabase.net/k897003/ 1990-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k897003-olympus-hysteroresectoscope-fda-510k.jpg K897003 - OLYMPUS HYSTERORESECTOSCOPE K897003 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Olympus Corp.. Cleared Mar 1990. https://www.510kdatabase.net/k897039/ 1990-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k897039-sarns-miniprime-cardioplegia-set-fda-510k.jpg K897039 - SARNS MINIPRIME CARDIOPLEGIA SET W/CONDUCER(TM) K897039 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: 3M Company. Cleared Mar 1990. https://www.510kdatabase.net/k897041/ 1990-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k897041-hemaquettm-and-hemaflextm-introducers-fda-510k.jpg K897041 - HEMAQUET(TM) AND HEMAFLEX(TM) INTRODUCERS K897041 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 1990. https://www.510kdatabase.net/k896174/ 1990-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k896174-protein-s-antigen-rocket-eid-kit-cat-fda-510k.jpg K896174 - PROTEIN S ANTIGEN ROCKET EID KIT, CAT. NO. 5359 K896174 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Mar 1990. https://www.510kdatabase.net/k897175/ 1990-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k897175-olympus-direct-bilirubin-fda-510k.jpg K897175 - OLYMPUS DIRECT BILIRUBIN K897175 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Mar 1990. https://www.510kdatabase.net/k900309/ 1990-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k900309-venoject-ii-blood-collection-tubes-fda-510k.jpg K900309 - VENOJECT II BLOOD COLLECTION TUBES K900309 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Terumo Medical Corp.. Cleared Mar 1990. https://www.510kdatabase.net/k900763/ 1990-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k900763-enzymun-testr-fsh-fda-510k.jpg K900763 - ENZYMUN TEST(R) FSH K900763 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Mar 1990. https://www.510kdatabase.net/k900821/ 1990-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k900821-autosceptor-gram-positive-mic-panel-fda-510k.jpg K900821 - AUTOSCEPTOR-GRAM-POSITIVE MIC PANEL READING K900821 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1990. https://www.510kdatabase.net/k897101/ 1990-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k897101-disposable-prophy-angle-and-accessories-fda-510k.jpg K897101 - DISPOSABLE PROPHY ANGLE AND ACCESSORIES K897101 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Mar 1990. https://www.510kdatabase.net/k900593/ 1990-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k900593-technicon-h2tm-system-fda-510k.jpg K900593 - TECHNICON H*2(TM) SYSTEM K900593 is a FDA 510(k) cleared hematology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Mar 1990. https://www.510kdatabase.net/k897115/ 1990-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k897115-angiorex-cn-angiographic-x-ray-system-fda-510k.jpg K897115 - ANGIOREX C/N (ANGIOGRAPHIC X-RAY SYSTEM) K897115 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Mar 1990. https://www.510kdatabase.net/k900195/ 1990-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k900195-modified-gore-tex-surgical-tape-fda-510k.jpg K900195 - MODIFIED GORE-TEX SURGICAL TAPE K900195 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Mar 1990. https://www.510kdatabase.net/k894650/ 1990-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k894650-q-port-system-kit-fda-510k.jpg K894650 - Q-PORT SYSTEM KIT K894650 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Quinton, Inc.. Cleared Mar 1990. https://www.510kdatabase.net/k900891/ 1990-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k900891-modified-aml-acetabular-cup-prosthesis-fda-510k.jpg K900891 - MODIFIED AML + ACETABULAR CUP PROSTHESIS K900891 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Mar 1990. https://www.510kdatabase.net/k896359/ 1990-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k896359-ag-820pa-fi02-module-fda-510k.jpg K896359 - AG-820PA FI02 MODULE K896359 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Mar 1990. https://www.510kdatabase.net/k897071/ 1990-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k897071-roche-standards-for-the-cobas-ise-module-fda-510k.jpg K897071 - ROCHE STANDARDS FOR THE COBAS ISE MODULE K897071 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Mar 1990. https://www.510kdatabase.net/k897138/ 1990-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k897138-affinitytm-htshtm-fda-510k.jpg K897138 - AFFINITY(TM) HTSH(TM) K897138 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1990. https://www.510kdatabase.net/k900013/ 1990-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k900013-milenia-tm-digitoxin-fda-510k.jpg K900013 - MILENIA (TM) DIGITOXIN K900013 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Mar 1990. https://www.510kdatabase.net/k900064/ 1990-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k900064-vista-hpq-system-vista-mr-2055-hp-system-fda-510k.jpg K900064 - VISTA HPQ SYSTEM, VISTA MR 2055 HP SYSTEM K900064 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Mar 1990. https://www.510kdatabase.net/k900120/ 1990-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k900120-roche-separating-reagent-for-hdl-fda-510k.jpg K900120 - ROCHE SEPARATING REAGENT FOR HDL CHOLESTEROL K900120 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Mar 1990. https://www.510kdatabase.net/k900143/ 1990-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k900143-abuscreen-fp-for-methamphetamine-fda-510k.jpg K900143 - ABUSCREEN FP FOR METHAMPHETAMINE K900143 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Mar 1990. https://www.510kdatabase.net/k900775/ 1990-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k900775-novapath-sp-advanced-liquid-handling-fda-510k.jpg K900775 - NOVAPATH SP ADVANCED LIQUID HANDLING SYSTEM K900775 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Mar 1990. https://www.510kdatabase.net/k894478/ 1990-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k894478-uhmwpe-surgical-mesh-fda-510k.jpg K894478 - UHMWPE SURGICAL MESH K894478 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Biomet, Inc.. Cleared Mar 1990. https://www.510kdatabase.net/k896456/ 1990-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k896456-tct-500s-computed-tomography-x-ray-fda-510k.jpg K896456 - TCT-500S COMPUTED TOMOGRAPHY X-RAY SYSTEM K896456 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Mar 1990. https://www.510kdatabase.net/k897013/ 1990-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k897013-avi-micro-210cm-infusion-pump-fda-510k.jpg K897013 - AVI MICRO 210CM INFUSION PUMP K897013 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Mar 1990. https://www.510kdatabase.net/k900402/ 1990-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k900402-addl-uses-for-the-kodak-surecell-fda-510k.jpg K900402 - ADD'L USES FOR THE KODAK SURECELL CHLAMYDIA KIT K900402 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Eastman Kodak Company. Cleared Mar 1990. https://www.510kdatabase.net/k894250/ 1990-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k894250-le-pta-catheter-fda-510k.jpg K894250 - LE PTA CATHETER K894250 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 1990. https://www.510kdatabase.net/k896278/ 1990-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k896278-sceptor-new-antimicrobial-agent-fda-510k.jpg K896278 - SCEPTOR - NEW ANTIMICROBIAL AGENT - CEFOTETAN K896278 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1990. https://www.510kdatabase.net/k895356/ 1990-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k895356-univox-ic-fda-510k.jpg K895356 - UNIVOX-IC K895356 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 1990. https://www.510kdatabase.net/k896313/ 1990-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k896313-medtronic-implantable-pacing-leads-wis-fda-510k.jpg K896313 - MEDTRONIC IMPLANTABLE PACING LEADS W/IS-1 CONN. K896313 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Mar 1990. https://www.510kdatabase.net/k896920/ 1990-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k896920-sidewinder-40cc-dl-intra-aortic-fda-510k.jpg K896920 - SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATHETER K896920 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Mar 1990. https://www.510kdatabase.net/k900377/ 1990-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k900377-college-of-amer-path-refer-prep-for-fda-510k.jpg K900377 - COLLEGE OF AMER PATH. REFER. PREP. FOR FIBRINOGEN K900377 is a FDA 510(k) cleared hematology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 1990. https://www.510kdatabase.net/k900406/ 1990-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k900406-factor-v-deficient-plasma-fda-510k.jpg K900406 - FACTOR V DEFICIENT PLASMA K900406 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Chemical Co.. Cleared Mar 1990. https://www.510kdatabase.net/k900407/ 1990-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k900407-factor-vii-deficient-plasma-fda-510k.jpg K900407 - FACTOR VII DEFICIENT PLASMA K900407 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Chemical Co.. Cleared Mar 1990. https://www.510kdatabase.net/k900408/ 1990-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k900408-factor-viii-deficient-plasma-fda-510k.jpg K900408 - FACTOR VIII DEFICIENT PLASMA K900408 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Chemical Co.. Cleared Mar 1990. https://www.510kdatabase.net/k900409/ 1990-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k900409-factor-ix-deficient-plasma-fda-510k.jpg K900409 - FACTOR IX DEFICIENT PLASMA K900409 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Chemical Co.. Cleared Mar 1990. https://www.510kdatabase.net/k900410/ 1990-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k900410-factor-x-deficient-plasma-fda-510k.jpg K900410 - FACTOR X DEFICIENT PLASMA K900410 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Chemical Co.. Cleared Mar 1990. https://www.510kdatabase.net/k900411/ 1990-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k900411-factor-xi-deficient-plasma-fda-510k.jpg K900411 - FACTOR XI DEFICIENT PLASMA K900411 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Chemical Co.. Cleared Mar 1990. https://www.510kdatabase.net/k900412/ 1990-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k900412-factor-xii-deficient-plasma-fda-510k.jpg K900412 - FACTOR XII DEFICIENT PLASMA K900412 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Chemical Co.. Cleared Mar 1990. https://www.510kdatabase.net/k900462/ 1990-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k900462-osteonics-cement-restrictor-fda-510k.jpg K900462 - OSTEONICS CEMENT RESTRICTOR K900462 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Mar 1990. https://www.510kdatabase.net/k900906/ 1990-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k900906-factor-ii-deficient-plasma-fda-510k.jpg K900906 - FACTOR II DEFICIENT PLASMA K900906 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Chemical Co.. Cleared Mar 1990. https://www.510kdatabase.net/k895449/ 1990-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k895449-aloka-model-ssd-650-ultrasound-imaging-fda-510k.jpg K895449 - ALOKA MODEL SSD-650 ULTRASOUND IMAGING SYSTEM K895449 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Mar 1990. https://www.510kdatabase.net/k897134/ 1990-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k897134-cmw-cement-pressurisation-system-fda-510k.jpg K897134 - CMW CEMENT PRESSURISATION SYSTEM K897134 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Dentsply Intl.. Cleared Mar 1990. https://www.510kdatabase.net/k900124/ 1990-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k900124-apolipoprotein-b-apo-b-fda-510k.jpg K900124 - APOLIPOPROTEIN B (APO B) K900124 is a FDA 510(k) cleared immunology medical device. Manufacturer: Sigma Chemical Co.. Cleared Mar 1990. https://www.510kdatabase.net/k896991/ 1990-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k896991-enzymun-testr-tbk-fda-510k.jpg K896991 - ENZYMUN TEST(R) TBK K896991 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Mar 1990. https://www.510kdatabase.net/k897158/ 1990-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k897158-abbott-commander-parallel-processing-fda-510k.jpg K897158 - ABBOTT COMMANDER PARALLEL PROCESSING CENTER K897158 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1990. https://www.510kdatabase.net/k900300/ 1990-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k900300-lytening-2z-lytening-system-31-fda-510k.jpg K900300 - LYTENING 2Z LYTENING SYSTEM 31 K900300 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 1990. https://www.510kdatabase.net/k893711/ 1990-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k893711-dideco-shiley-autotransfusion-fda-510k.jpg K893711 - DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIR K893711 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Feb 1990. https://www.510kdatabase.net/k896978/ 1990-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k896978-closed-chest-support-circuit-wbio-fda-510k.jpg K896978 - CLOSED CHEST SUPPORT CIRCUIT W/BIO-ACTIVE SURFACE K896978 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Feb 1990. https://www.510kdatabase.net/k896232/ 1990-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k896232-cobas-ready-total-bilirubin-reagent-fda-510k.jpg K896232 - COBAS READY TOTAL BILIRUBIN REAGENT K896232 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Feb 1990. https://www.510kdatabase.net/k896235/ 1990-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k896235-cobas-ready-albumin-reagent-fda-510k.jpg K896235 - COBAS READY ALBUMIN REAGENT K896235 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Feb 1990. https://www.510kdatabase.net/k896236/ 1990-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k896236-cobas-ready-bun-reagent-fda-510k.jpg K896236 - COBAS READY BUN REAGENT K896236 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Feb 1990. https://www.510kdatabase.net/k900129/ 1990-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k900129-modified-auto-suture-endoscopic-gia-fda-510k.jpg K900129 - MODIFIED AUTO SUTURE ENDOSCOPIC GIA SURG. STAPLER* K900129 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Feb 1990. https://www.510kdatabase.net/k900422/ 1990-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k900422-titan-gel-immunofix-kit-cat-no-3046-fda-510k.jpg K900422 - TITAN GEL IMMUNOFIX KIT, CAT. NO. 3046 K900422 is a FDA 510(k) cleared immunology medical device. Manufacturer: Helena Laboratories. Cleared Feb 1990. https://www.510kdatabase.net/k895044/ 1990-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k895044-dual-guide-introducer-catheter-fda-510k.jpg K895044 - DUAL GUIDE INTRODUCER CATHETER K895044 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Feb 1990. https://www.510kdatabase.net/k896907/ 1990-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k896907-3m-iv-flow-regulator-fda-510k.jpg K896907 - 3M IV FLOW REGULATOR K896907 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Feb 1990. https://www.510kdatabase.net/k900233/ 1990-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k900233-tct-300s-upgrade-fda-510k.jpg K900233 - TCT-300S - UPGRADE K900233 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Feb 1990. https://www.510kdatabase.net/k900251/ 1990-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k900251-rep-spe-plus-8-ponceau-s-3165-plus-8-fda-510k.jpg K900251 - REP SPE PLUS-8 (PONCEAU S) 3165, PLUS-8 NO. 3175 K900251 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Feb 1990. https://www.510kdatabase.net/k900620/ 1990-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k900620-du-pont-mammography-cassette-fda-510k.jpg K900620 - DU PONT MAMMOGRAPHY CASSETTE K900620 is a FDA 510(k) cleared radiology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Feb 1990. https://www.510kdatabase.net/k896387/ 1990-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k896387-sxt-60f60m-mobile-c-arm-x-ray-unit-fda-510k.jpg K896387 - SXT-60F/60M MOBILE C ARM X-RAY UNIT K896387 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Feb 1990. https://www.510kdatabase.net/k896744/ 1990-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k896744-benzodiazepinestricyclic-fda-510k.jpg K896744 - BENZODIAZEPINES/TRICYCLIC ANTIDEPRESSANTS BY HPLC K896744 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bio-Rad. Cleared Feb 1990. https://www.510kdatabase.net/k896829/ 1990-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k896829-technicon-ra-systems-sodium-fda-510k.jpg K896829 - TECHNICON RA SYSTEMS SODIUM (COLORIMETRIC METHOD) K896829 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Feb 1990. https://www.510kdatabase.net/k896954/ 1990-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k896954-abbott-spectrum-uric-acid-reagent-kit-fda-510k.jpg K896954 - ABBOTT SPECTRUM URIC ACID REAGENT KIT K896954 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Feb 1990. https://www.510kdatabase.net/k897098/ 1990-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k897098-siemens-endo-p-probe-fda-510k.jpg K897098 - SIEMENS ENDO-P-PROBE K897098 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 1990. https://www.510kdatabase.net/k897152/ 1990-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k897152-cragg-convertible-wire-fda-510k.jpg K897152 - CRAGG CONVERTIBLE WIRE K897152 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Feb 1990. https://www.510kdatabase.net/k900108/ 1990-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k900108-3m-multi-aller-ige-fastscreen-s9-fda-510k.jpg K900108 - 3M MULTI-ALLER. IGE FASTSCREEN S9 W1,6,9,10,11,12 K900108 is a FDA 510(k) cleared immunology medical device. Manufacturer: 3M Company. Cleared Feb 1990. https://www.510kdatabase.net/k900244/ 1990-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k900244-3m-multi-allergen-ige-fastscreentm-s8-fda-510k.jpg K900244 - 3M MULTI-ALLERGEN IGE FASTSCREEN(TM) S8 K900244 is a FDA 510(k) cleared immunology medical device. Manufacturer: 3M Company. Cleared Feb 1990. https://www.510kdatabase.net/k895335/ 1990-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k895335-cronex-compact-mammography-cassette-fda-510k.jpg K895335 - CRONEX COMPACT MAMMOGRAPHY CASSETTE K895335 is a FDA 510(k) cleared radiology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Feb 1990. https://www.510kdatabase.net/k896170/ 1990-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k896170-rep-ck-isoforms-kit-cat-no-3081-3082-fda-510k.jpg K896170 - REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083 K896170 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Feb 1990. https://www.510kdatabase.net/k896227/ 1990-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k896227-cobas-ready-uric-acid-reagent-fda-510k.jpg K896227 - COBAS READY URIC ACID REAGENT K896227 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Feb 1990. https://www.510kdatabase.net/k896228/ 1990-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k896228-cobas-ready-cardio-profile-reagent-strip-fda-510k.jpg K896228 - COBAS READY CARDIO PROFILE REAGENT STRIP K896228 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Feb 1990. https://www.510kdatabase.net/k896229/ 1990-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k896229-cobas-ready-profile-1-reagent-strip-fda-510k.jpg K896229 - COBAS READY PROFILE 1 REAGENT STRIP K896229 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Feb 1990. https://www.510kdatabase.net/k896230/ 1990-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k896230-cobas-ready-total-protein-reagent-fda-510k.jpg K896230 - COBAS READY TOTAL PROTEIN REAGENT K896230 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Feb 1990. https://www.510kdatabase.net/k896231/ 1990-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k896231-cobas-ready-triglyceride-reagent-fda-510k.jpg K896231 - COBAS READY TRIGLYCERIDE REAGENT K896231 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Feb 1990. https://www.510kdatabase.net/k896233/ 1990-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k896233-cobas-ready-liver-profile-reagent-strip-fda-510k.jpg K896233 - COBAS READY LIVER PROFILE REAGENT STRIP K896233 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Feb 1990. https://www.510kdatabase.net/k896234/ 1990-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k896234-cobas-ready-stat-profile-reagent-strip-fda-510k.jpg K896234 - COBAS READY STAT PROFILE REAGENT STRIP K896234 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Feb 1990. https://www.510kdatabase.net/k896237/ 1990-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k896237-cobas-ready-alt-reagent-fda-510k.jpg K896237 - COBAS READY ALT REAGENT K896237 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Feb 1990. https://www.510kdatabase.net/k896238/ 1990-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k896238-cobas-ready-ast-reagent-fda-510k.jpg K896238 - COBAS READY AST REAGENT K896238 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Feb 1990. https://www.510kdatabase.net/k896239/ 1990-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k896239-cobas-ready-cholesterol-reagent-fda-510k.jpg K896239 - COBAS READY CHOLESTEROL REAGENT K896239 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Feb 1990. https://www.510kdatabase.net/k896240/ 1990-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k896240-cobas-ready-ck-reagent-fda-510k.jpg K896240 - COBAS READY CK REAGENT K896240 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Feb 1990. https://www.510kdatabase.net/k896241/ 1990-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k896241-cobas-ready-ldh-reagent-fda-510k.jpg K896241 - COBAS READY LDH REAGENT K896241 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Feb 1990. https://www.510kdatabase.net/k896521/ 1990-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k896521-modified-paramax-uric-acid-reagent-fda-510k.jpg K896521 - MODIFIED PARAMAX URIC ACID REAGENT K896521 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Baxter Healthcare Corp. Cleared Feb 1990. https://www.510kdatabase.net/k896935/ 1990-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k896935-convertors-breathable-gown-material-fda-510k.jpg K896935 - CONVERTORS BREATHABLE GOWN MATERIAL PRODUCT LINE K896935 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Feb 1990. https://www.510kdatabase.net/k900448/ 1990-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k900448-cronex-quanta-rapid-sr397-rare-earth-fda-510k.jpg K900448 - CRONEX QUANTA RAPID SR397 RARE EARTH INTENS SCREEN K900448 is a FDA 510(k) cleared radiology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Feb 1990. https://www.510kdatabase.net/k897045/ 1990-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k897045-bowie-dick-test-card-catalog-number-fda-510k.jpg K897045 - BOWIE-DICK TEST CARD CATALOG NUMBER 008018 K897045 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Edward Weck, Inc.. Cleared Feb 1990. https://www.510kdatabase.net/k897192/ 1990-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k897192-triflex-orthopedic-sterile-surgeons-fda-510k.jpg K897192 - TRIFLEX ORTHOPEDIC STERILE SURGEON'S GLOVE K897192 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Feb 1990. https://www.510kdatabase.net/k896671/ 1990-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k896671-sarns-membrane-oxygenator-wintegral-fda-510k.jpg K896671 - SARNS MEMBRANE OXYGENATOR W/INTEGRAL RESER. #9461 K896671 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: 3M Company. Cleared Feb 1990. https://www.510kdatabase.net/k896258/ 1990-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k896258-co2-reagent-340-nm-fda-510k.jpg K896258 - CO2 REAGENT (340 NM) K896258 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Feb 1990. https://www.510kdatabase.net/k900332/ 1990-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k900332-em-1149-optimize-scotchplate-conduc-fda-510k.jpg K900332 - EM 1149 OPTIMIZE SCOTCHPLATE CONDUC ADHES DISP ELE K900332 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3M Company. Cleared Feb 1990. https://www.510kdatabase.net/k896597/ 1990-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k896597-the-sidewinder-40cc-dl-intra-aortic-fda-510k.jpg K896597 - THE SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATH. K896597 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Feb 1990. https://www.510kdatabase.net/k896564/ 1990-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k896564-dental-core-material-fda-510k.jpg K896564 - DENTAL CORE MATERIAL K896564 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Feb 1990. https://www.510kdatabase.net/k900043/ 1990-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k900043-modified-powered-disposable-lds-fda-510k.jpg K900043 - MODIFIED POWERED DISPOSABLE LDS SURGICAL STAPLER K900043 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Feb 1990. https://www.510kdatabase.net/k900055/ 1990-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k900055-modified-pss-pfs-powered-skin-fascia-fda-510k.jpg K900055 - MODIFIED PSS & PFS POWERED SKIN & FASCIA STAPLERS K900055 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Feb 1990. https://www.510kdatabase.net/k900487/ 1990-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k900487-modified-auto-suture-surgiport-trocar-fda-510k.jpg K900487 - MODIFIED AUTO SUTURE SURGIPORT TROCAR & SLEEVE K900487 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Feb 1990. https://www.510kdatabase.net/k892380/ 1990-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k892380-dader-immunoassay-controls-levels-i-ii-fda-510k.jpg K892380 - DADE(R) IMMUNOASSAY CONTROLS, LEVELS I, II, III K892380 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Feb 1990. https://www.510kdatabase.net/k895136/ 1990-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k895136-permanent-and-temp-pacemaker-electrode-fda-510k.jpg K895136 - PERMANENT AND TEMP. PACEMAKER ELECTRODE & LEAD ADA K895136 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Feb 1990. https://www.510kdatabase.net/k895639/ 1990-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k895639-mg-ii-porous-total-knee-systemmetal-fda-510k.jpg K895639 - MG II POROUS TOTAL KNEE SYSTEM/METAL-BACK PATELLAR K895639 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Feb 1990. https://www.510kdatabase.net/k896466/ 1990-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k896466-swan-ganz-thermodilution-ejection-fda-510k.jpg K896466 - SWAN-GANZ THERMODILUTION EJECTION FRACTION/VOLUME K896466 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Feb 1990. https://www.510kdatabase.net/k896650/ 1990-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k896650-amylase-reagent-fda-510k.jpg K896650 - AMYLASE REAGENT K896650 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Feb 1990. https://www.510kdatabase.net/k896900/ 1990-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k896900-enzymun-test-r-t3-fda-510k.jpg K896900 - ENZYMUN TEST R T3 K896900 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Feb 1990. https://www.510kdatabase.net/k896901/ 1990-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k896901-enzymun-test-r-hcg-fda-510k.jpg K896901 - ENZYMUN TEST R HCG K896901 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Feb 1990. https://www.510kdatabase.net/k896435/ 1990-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k896435-hp-sonos-500-and-sonos-1000-ultra-fda-510k.jpg K896435 - HP SONOS 500 AND SONOS 1000 ULTRA. IMAGING SYSTEM K896435 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Feb 1990. https://www.510kdatabase.net/k896856/ 1990-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k896856-mod-ml-unicompartmental-knee-prosthesis-fda-510k.jpg K896856 - MOD-ML UNICOMPARTMENTAL KNEE PROSTHESIS K896856 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Feb 1990. https://www.510kdatabase.net/k896430/ 1990-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k896430-percor-stat-dl-95-fr-stat-sl-85-fr-fda-510k.jpg K896430 - PERCOR STAT-DL 9.5 FR & STAT-SL 8.5 FR INTRA-AORTI K896430 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Feb 1990. https://www.510kdatabase.net/k897136/ 1990-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k897136-protein-c-antigen-rocket-eid-method-no-fda-510k.jpg K897136 - PROTEIN C ANTIGEN ROCKET EID METHOD NO. 5357 K897136 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Feb 1990. https://www.510kdatabase.net/k900103/ 1990-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k900103-cronex-quanta-sr300-intensifying-screen-fda-510k.jpg K900103 - CRONEX QUANTA SR300 INTENSIFYING SCREEN K900103 is a FDA 510(k) cleared radiology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Feb 1990. https://www.510kdatabase.net/k900318/ 1990-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k900318-cronex-quanta-super-rapid-sr339-rare-fda-510k.jpg K900318 - CRONEX QUANTA SUPER RAPID SR339 RARE EARTH K900318 is a FDA 510(k) cleared radiology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Feb 1990. https://www.510kdatabase.net/k891289/ 1990-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k891289-flo-gard-6300-dual-channel-volume-fda-510k.jpg K891289 - FLO-GARD 6300 DUAL CHANNEL VOLUME INFUSION PUMP K891289 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Feb 1990. https://www.510kdatabase.net/k892642/ 1990-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k892642-dader-tdm-control-fda-510k.jpg K892642 - DADE(R) TDM CONTROL K892642 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Feb 1990. https://www.510kdatabase.net/k894403/ 1990-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k894403-pca-modular-knee-constrained-tibial-fda-510k.jpg K894403 - PCA MODULAR KNEE CONSTRAINED TIBIAL INSERT K894403 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Feb 1990. https://www.510kdatabase.net/k896635/ 1990-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k896635-viral-respiratory-indirect-fluores-fda-510k.jpg K896635 - VIRAL RESPIRATORY INDIRECT FLUORES. MONO. ANTIBODY K896635 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Feb 1990. https://www.510kdatabase.net/k895839/ 1990-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k895839-pathodx-chlamydia-culture-confirmation-fda-510k.jpg K895839 - PATHODX CHLAMYDIA CULTURE CONFIRMATION PKCC1 K895839 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Feb 1990. https://www.510kdatabase.net/k896348/ 1990-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k896348-argelite-80-5-dental-alloy-for-fda-510k.jpg K896348 - ARGELITE 80 + 5 DENTAL ALLOY FOR PORCELAIN APPL. K896348 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Feb 1990. https://www.510kdatabase.net/k896382/ 1990-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k896382-modified-gluma-bonding-system-fda-510k.jpg K896382 - MODIFIED GLUMA BONDING SYSTEM K896382 is a FDA 510(k) cleared dental medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Feb 1990. https://www.510kdatabase.net/k896846/ 1990-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k896846-madin-darby-canine-kidney-culture-cells-fda-510k.jpg K896846 - MADIN-DARBY CANINE KIDNEY CULTURE CELLS K896846 is a FDA 510(k) cleared pathology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Feb 1990. https://www.510kdatabase.net/k894937/ 1990-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k894937-shaw-knee-modular-tibial-tray-porous-fda-510k.jpg K894937 - SHAW KNEE MODULAR TIBIAL TRAY-POROUS K894937 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jan 1990. https://www.510kdatabase.net/k895035/ 1990-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k895035-titanium-modular-collared-hip-prosthesis-fda-510k.jpg K895035 - TITANIUM MODULAR COLLARED HIP PROSTHESIS K895035 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jan 1990. https://www.510kdatabase.net/k895036/ 1990-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k895036-titanium-modular-modular-collarless-hip-fda-510k.jpg K895036 - TITANIUM MODULAR MODULAR COLLARLESS HIP K895036 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jan 1990. https://www.510kdatabase.net/k895074/ 1990-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k895074-angioscopy-pump-fda-510k.jpg K895074 - ANGIOSCOPY PUMP K895074 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jan 1990. https://www.510kdatabase.net/k896414/ 1990-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k896414-venous-reservoir-bag-model-no-bmr-800-fda-510k.jpg K896414 - VENOUS RESERVOIR BAG MODEL NO. BMR-800 W/HEPARIN K896414 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jan 1990. https://www.510kdatabase.net/k900125/ 1990-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k900125-arteriovenous-fistula-sets-fda-510k.jpg K900125 - ARTERIOVENOUS FISTULA SETS K900125 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jan 1990. https://www.510kdatabase.net/k900272/ 1990-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k900272-nka-models-ab-601g-and-ab-621g-fda-510k.jpg K900272 - NKA MODELS AB-601G AND AB-621G K900272 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Jan 1990. https://www.510kdatabase.net/k895631/ 1990-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k895631-disconnect-caps-product-codes-5c4212-fda-510k.jpg K895631 - DISCONNECT CAPS PRODUCT CODES 5C4212 AND 5C4466 K895631 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jan 1990. https://www.510kdatabase.net/k895673/ 1990-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k895673-connection-shields-codes-5c4213-and-fda-510k.jpg K895673 - CONNECTION SHIELDS CODES 5C4213 AND 5C4215 K895673 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jan 1990. https://www.510kdatabase.net/k896252/ 1990-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k896252-modified-quinton-single-lumen-catheter-fda-510k.jpg K896252 - MODIFIED QUINTON SINGLE LUMEN CATHETER K896252 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quinton, Inc.. Cleared Jan 1990. https://www.510kdatabase.net/k896325/ 1990-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k896325-quantum-hip-stem-fda-510k.jpg K896325 - QUANTUM HIP STEM K896325 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jan 1990. https://www.510kdatabase.net/k900017/ 1990-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k900017-rep-glyco-control-normal3209-and-fda-510k.jpg K900017 - REP GLYCO CONTROL NORMAL(3209) AND ABNORMAL(3210) K900017 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Jan 1990. https://www.510kdatabase.net/k894899/ 1990-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k894899-expansion-of-the-cordis-pta-dilatation-fda-510k.jpg K894899 - EXPANSION OF THE CORDIS PTA DILATATION CATHETER K894899 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Jan 1990. https://www.510kdatabase.net/k895906/ 1990-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k895906-abuscreen-ontrak-for-phencyclidine-pcp-fda-510k.jpg K895906 - ABUSCREEN ONTRAK FOR PHENCYCLIDINE (PCP) K895906 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jan 1990. https://www.510kdatabase.net/k896809/ 1990-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k896809-medtronic-spectrax-sxt-model-8423m-fda-510k.jpg K896809 - MEDTRONIC SPECTRAX SXT MODEL 8423M PULSE GENERATOR K896809 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jan 1990. https://www.510kdatabase.net/k900019/ 1990-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k900019-rocket-reference-plasma-cat-no-5188-fda-510k.jpg K900019 - ROCKET REFERENCE PLASMA, CAT NO. 5188 K900019 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Jan 1990. https://www.510kdatabase.net/k896365/ 1990-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k896365-babyflex-heated-infant-breathing-circuit-fda-510k.jpg K896365 - BABYFLEX HEATED INFANT BREATHING CIRCUIT K896365 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jan 1990. https://www.510kdatabase.net/k900167/ 1990-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k900167-turbiquant-immunoglobulin-albumin-kit-fda-510k.jpg K900167 - TURBIQUANT IMMUNOGLOBULIN & ALBUMIN KIT K900167 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Jan 1990. https://www.510kdatabase.net/k894631/ 1990-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k894631-nka-model-mfv-3100-mfv-3200-electro-fda-510k.jpg K894631 - NKA MODEL MFV-3100 & MFV-3200 ELECTRO. BLOOD FLOW. K894631 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Jan 1990. https://www.510kdatabase.net/k895318/ 1990-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k895318-b-d-angiographic-control-syringe-fda-510k.jpg K895318 - B-D ANGIOGRAPHIC CONTROL SYRINGE K895318 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jan 1990. https://www.510kdatabase.net/k896162/ 1990-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k896162-abbott-imx-prolactin-fda-510k.jpg K896162 - ABBOTT IMX PROLACTIN K896162 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jan 1990. https://www.510kdatabase.net/k896257/ 1990-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k896257-leinbach-hip-prosthesis-fda-510k.jpg K896257 - LEINBACH HIP PROSTHESIS K896257 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 3M Company. Cleared Jan 1990. https://www.510kdatabase.net/k896415/ 1990-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k896415-usci-presto-disposable-inflation-device-fda-510k.jpg K896415 - USCI PRESTO DISPOSABLE INFLATION DEVICE K896415 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 1990. https://www.510kdatabase.net/k896819/ 1990-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k896819-vamp-venousarterial-blood-management-fda-510k.jpg K896819 - VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION K896819 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jan 1990. https://www.510kdatabase.net/k896916/ 1990-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k896916-clinistat-total-protein-reagent-test-fda-510k.jpg K896916 - CLINISTAT TOTAL PROTEIN REAGENT TEST K896916 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Jan 1990. https://www.510kdatabase.net/k900014/ 1990-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k900014-milenia-tm-tsh-fda-510k.jpg K900014 - MILENIA (TM) TSH K900014 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jan 1990. https://www.510kdatabase.net/k895905/ 1990-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k895905-lyphochek-whole-blood-control-human-fda-510k.jpg K895905 - LYPHOCHEK WHOLE BLOOD CONTROL (HUMAN) LEVELS 1,2,3 K895905 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bio-Rad. Cleared Jan 1990. https://www.510kdatabase.net/k896168/ 1990-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k896168-hemoglobin-a2-micro-column-test-fda-510k.jpg K896168 - HEMOGLOBIN A2 MICRO COLUMN TEST K896168 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bio-Rad. Cleared Jan 1990. https://www.510kdatabase.net/k896927/ 1990-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k896927-vision-theophylline-ii-fda-510k.jpg K896927 - VISION THEOPHYLLINE II K896927 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Jan 1990. https://www.510kdatabase.net/k897114/ 1990-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k897114-emit-convenience-pack-carbamazepine-fda-510k.jpg K897114 - EMIT CONVENIENCE PACK: CARBAMAZEPINE ASSAY K897114 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jan 1990. https://www.510kdatabase.net/k900107/ 1990-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k900107-ld-1-fda-510k.jpg K900107 - LD-1 K900107 is a FDA 510(k) cleared immunology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jan 1990. https://www.510kdatabase.net/k896070/ 1990-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k896070-pfeiffer-metered-dosage-system-fda-510k.jpg K896070 - PFEIFFER METERED DOSAGE SYSTEM K896070 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Syva Co.. Cleared Jan 1990. https://www.510kdatabase.net/k896216/ 1990-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k896216-hewlett-packard-anesthetic-gas-fda-510k.jpg K896216 - HEWLETT PACKARD ANESTHETIC GAS ANALYZER M1025A K896216 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Jan 1990. https://www.510kdatabase.net/k896508/ 1990-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k896508-vista-mr-2055-hp-system-fda-510k.jpg K896508 - VISTA MR 2055 HP SYSTEM K896508 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Jan 1990. https://www.510kdatabase.net/k895120/ 1990-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k895120-bateman-upf-ii-hip-prosthesis-system-fda-510k.jpg K895120 - BATEMAN UPF II HIP PROSTHESIS SYSTEM K895120 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 3M Company. Cleared Jan 1990. https://www.510kdatabase.net/k896161/ 1990-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k896161-avi-model-2012-12-micron-filter-iv-fda-510k.jpg K896161 - AVI MODEL 2012, 1.2 MICRON FILTER IV ADMINISTRA. K896161 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Jan 1990. https://www.510kdatabase.net/k896454/ 1990-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k896454-chemstripr-10-with-sg-urine-test-strips-fda-510k.jpg K896454 - CHEMSTRIP(R) 10 WITH SG URINE TEST STRIPS K896454 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jan 1990. https://www.510kdatabase.net/k896572/ 1990-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k896572-reptm-spe-plus-30-procedures-fda-510k.jpg K896572 - REP(TM) SPE PLUS-30 PROCEDURES K896572 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Jan 1990. https://www.510kdatabase.net/k896902/ 1990-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k896902-enzymun-test-r-ige-fda-510k.jpg K896902 - ENZYMUN TEST R IGE K896902 is a FDA 510(k) cleared immunology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jan 1990. https://www.510kdatabase.net/k897145/ 1990-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k897145-3m-multi-allergen-ige-fastscreen-s7-fda-510k.jpg K897145 - 3M MULTI-ALLERGEN IGE FASTSCREEN S7, (G3,4,5,6,8) K897145 is a FDA 510(k) cleared immunology medical device. Manufacturer: 3M Company. Cleared Jan 1990. https://www.510kdatabase.net/k892411/ 1990-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k892411-mennen-bone-fixation-device-fda-510k.jpg K892411 - MENNEN BONE FIXATION DEVICE K892411 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Dentsply Intl.. Cleared Jan 1990. https://www.510kdatabase.net/k896452/ 1990-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k896452-kinemax-tibial-stem-extension-fda-510k.jpg K896452 - KINEMAX TIBIAL STEM EXTENSION K896452 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jan 1990. https://www.510kdatabase.net/k895505/ 1990-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k895505-kodak-surecell-chlamydia-test-kit-addl-fda-510k.jpg K895505 - KODAK SURECELL CHLAMYDIA TEST KIT (ADD'L USES) K895505 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Eastman Kodak Company. Cleared Jan 1990. https://www.510kdatabase.net/k895679/ 1990-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k895679-cefmatzole-30-mcg-sensi-disc-fda-510k.jpg K895679 - CEFMATZOLE 30 MCG SENSI DISC K895679 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jan 1990. https://www.510kdatabase.net/k895878/ 1990-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k895878-olympus-valvulotome-wdetachable-tip-fda-510k.jpg K895878 - OLYMPUS VALVULOTOME W/DETACHABLE TIP K895878 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Olympus Corp.. Cleared Jan 1990. https://www.510kdatabase.net/k896447/ 1990-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k896447-autosceptor-fda-510k.jpg K896447 - AUTOSCEPTOR K896447 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jan 1990. https://www.510kdatabase.net/k896526/ 1990-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k896526-lyteningtm-5-lyteningtm-system-30-fda-510k.jpg K896526 - LYTENING(TM) 5, LYTENING(TM) SYSTEM 30 K896526 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jan 1990. https://www.510kdatabase.net/k896692/ 1990-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k896692-amdev-lytening-2-sodiumpotassiumlithiuma-fda-510k.jpg K896692 - AMDEV LYTENING 2 SODIUM/POTASSIUM/LITHIUM/ANALYZER K896692 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jan 1990. https://www.510kdatabase.net/k885221/ 1989-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k885221-multilumen-central-venous-catheter-fda-510k.jpg K885221 - MULTILUMEN CENTRAL VENOUS CATHETER K885221 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Dec 1989. https://www.510kdatabase.net/k895139/ 1989-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k895139-clinistat-hdl-cholesterol-reagent-test-fda-510k.jpg K895139 - CLINISTAT HDL CHOLESTEROL REAGENT TEST K895139 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Dec 1989. https://www.510kdatabase.net/k895465/ 1989-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k895465-amdev-lytening-2z-sodiumpotassiumlithium-fda-510k.jpg K895465 - AMDEV LYTENING 2Z SODIUM/POTASSIUM/LITHIUM ANALYZE K895465 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Baxter Healthcare Corp. Cleared Dec 1989. https://www.510kdatabase.net/k895883/ 1989-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k895883-beckman-ma-microalbumin-reagent-kit-fda-510k.jpg K895883 - BECKMAN MA MICROALBUMIN REAGENT KIT K895883 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Dec 1989. https://www.510kdatabase.net/k896006/ 1989-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k896006-dialysis-priming-sets-codes-5c4094-and-fda-510k.jpg K896006 - DIALYSIS PRIMING SETS CODES 5C4094 AND 5C4095 K896006 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Dec 1989. https://www.510kdatabase.net/k896593/ 1989-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k896593-becton-dickinson-rate-infuser-ii-system-fda-510k.jpg K896593 - BECTON DICKINSON RATE INFUSER II SYSTEM K896593 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Dec 1989. https://www.510kdatabase.net/k890624/ 1989-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k890624-tissue-oxygen-monitor-system-model-ii-fda-510k.jpg K890624 - TISSUE OXYGEN MONITOR SYSTEM, MODEL II K890624 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Dec 1989. https://www.510kdatabase.net/k894691/ 1989-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k894691-model-ao-800pa-co2-module-fda-510k.jpg K894691 - MODEL AO-800PA CO2 MODULE K894691 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Dec 1989. https://www.510kdatabase.net/k895849/ 1989-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k895849-respironics-vacuvest-respiratory-fda-510k.jpg K895849 - RESPIRONICS VACUVEST RESPIRATORY SUPPORT SYSTEM K895849 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Dec 1989. https://www.510kdatabase.net/k896030/ 1989-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k896030-hewlett-packard-model-m1016a-co2-fda-510k.jpg K896030 - HEWLETT-PACKARD MODEL M1016A CO2 & M1017A FI02 K896030 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Dec 1989. https://www.510kdatabase.net/k896353/ 1989-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k896353-ge-target-series-2-fda-510k.jpg K896353 - GE TARGET SERIES 2 K896353 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Dec 1989. https://www.510kdatabase.net/k896511/ 1989-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k896511-du-pont-xenolitetm-radiation-fda-510k.jpg K896511 - DU PONT XENOLITE(TM) RADIATION PROTECTION APPAREL K896511 is a FDA 510(k) cleared radiology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Dec 1989. https://www.510kdatabase.net/k894492/ 1989-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k894492-nka-model-sec-3102-cardiac-stimulator-fda-510k.jpg K894492 - NKA MODEL SEC-3102 CARDIAC STIMULATOR K894492 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Dec 1989. https://www.510kdatabase.net/k895836/ 1989-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k895836-inflation-pro-ii-fda-510k.jpg K895836 - INFLATION PRO II K895836 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Dec 1989. https://www.510kdatabase.net/k891691/ 1989-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k891691-lyphochek-urine-metals-control-levels-fda-510k.jpg K891691 - LYPHOCHEK URINE METALS CONTROL, LEVELS I AND II K891691 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bio-Rad. Cleared Dec 1989. https://www.510kdatabase.net/k895880/ 1989-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k895880-pancreatic-a-amylase-eps-fda-510k.jpg K895880 - PANCREATIC A-AMYLASE EPS K895880 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Dec 1989. https://www.510kdatabase.net/k896007/ 1989-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k896007-cobas-ready-fda-510k.jpg K896007 - COBAS READY K896007 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Dec 1989. https://www.510kdatabase.net/k896550/ 1989-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k896550-tdxr-barbiturates-ii-assay-fda-510k.jpg K896550 - TDX(R) BARBITURATES II ASSAY K896550 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Dec 1989. https://www.510kdatabase.net/k895742/ 1989-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k895742-liteline-vlc-soft-reline-fda-510k.jpg K895742 - LITELINE VLC SOFT RELINE K895742 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Dec 1989. https://www.510kdatabase.net/k894216/ 1989-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k894216-haemophilus-test-medium-htmagar-fda-510k.jpg K894216 - HAEMOPHILUS TEST MEDIUM (HTM)AGAR K894216 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Dec 1989. https://www.510kdatabase.net/k895199/ 1989-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k895199-biasol-liquid-concentrates-addl-acid-fda-510k.jpg K895199 - BIASOL LIQUID CONCENTRATES, ADD'L ACID CONCENTRATE K895199 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Dec 1989. https://www.510kdatabase.net/k896155/ 1989-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k896155-red-dot-cardiac-sensor-system-fda-510k.jpg K896155 - RED DOT CARDIAC SENSOR SYSTEM K896155 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: 3M Company. Cleared Dec 1989. https://www.510kdatabase.net/k896632/ 1989-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k896632-medtronic-model-5401b-test-cable-fda-510k.jpg K896632 - MEDTRONIC MODEL 5401B TEST CABLE K896632 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Dec 1989. https://www.510kdatabase.net/k895632/ 1989-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k895632-sarns-membrane-oxygenator-wintegral-fda-510k.jpg K895632 - SARNS MEMBRANE OXYGENATOR W/INTEGRAL CADIO. 16380 K895632 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: 3M Company. Cleared Dec 1989. https://www.510kdatabase.net/k884890/ 1989-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k884890-lord-lfr-total-hip-system-fda-510k.jpg K884890 - LORD L.F.R. TOTAL HIP SYSTEM K884890 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Dec 1989. https://www.510kdatabase.net/k895630/ 1989-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k895630-b-d-pend-needle-fda-510k.jpg K895630 - B-D PEND NEEDLE K895630 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Dec 1989. https://www.510kdatabase.net/k895421/ 1989-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k895421-cortisol-test-system-fda-510k.jpg K895421 - CORTISOL TEST SYSTEM K895421 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Baxter Healthcare Corp. Cleared Dec 1989. https://www.510kdatabase.net/k895779/ 1989-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k895779-modified-permcath-tray-2nd-submission-fda-510k.jpg K895779 - MODIFIED PERMCATH TRAY (2ND SUBMISSION) K895779 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Quinton, Inc.. Cleared Dec 1989. https://www.510kdatabase.net/k895789/ 1989-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k895789-unipolar-temp-myocardial-heart-wire-fda-510k.jpg K895789 - UNIPOLAR TEMP. MYOCARDIAL HEART WIRE, MODEL 6490 K895789 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Dec 1989. https://www.510kdatabase.net/k895816/ 1989-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k895816-bio-rad-blind-perfor-specimen-set-for-fda-510k.jpg K895816 - BIO-RAD BLIND PERFOR. SPECIMEN SET FOR NIDA REG. K895816 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bio-Rad. Cleared Dec 1989. https://www.510kdatabase.net/k891237/ 1989-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k891237-model-600-syringe-pump-fda-510k.jpg K891237 - MODEL 600 SYRINGE PUMP K891237 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Dec 1989. https://www.510kdatabase.net/k893646/ 1989-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k893646-volumetric-pump-solution-set-wintegral-fda-510k.jpg K893646 - VOLUMETRIC PUMP SOLUTION SET W/INTEGRAL AIRWAY K893646 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Dec 1989. https://www.510kdatabase.net/k894778/ 1989-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k894778-codman-rf-12-disposable-scalp-clip-fda-510k.jpg K894778 - CODMAN RF-12 DISPOSABLE SCALP CLIP APPLIER K894778 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Dec 1989. https://www.510kdatabase.net/k896601/ 1989-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k896601-exactech-bone-screw-fda-510k.jpg K896601 - EXACTECH BONE SCREW K896601 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Dec 1989. https://www.510kdatabase.net/k891121/ 1989-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k891121-medi-tech-amplatz-introducer-shealth-fda-510k.jpg K891121 - MEDI-TECH AMPLATZ INTRODUCER SHEALTH SYSTEM K891121 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Dec 1989. https://www.510kdatabase.net/k891719/ 1989-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k891719-tru-touch-vinyl-non-sterile-fda-510k.jpg K891719 - TRU-TOUCH VINYL, NON-STERILE K891719 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Dec 1989. https://www.510kdatabase.net/k892327/ 1989-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k892327-tru-touch-vinyl-sterile-fda-510k.jpg K892327 - TRU-TOUCH VINYL, STERILE K892327 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Dec 1989. https://www.510kdatabase.net/k892328/ 1989-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k892328-featherweight-vinyl-non-sterile-exam-fda-510k.jpg K892328 - FEATHERWEIGHT VINYL, NON-STERILE EXAM GLOVES K892328 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Dec 1989. https://www.510kdatabase.net/k895850/ 1989-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k895850-synchron-cx-systems-lap-reagent-kit-fda-510k.jpg K895850 - SYNCHRON CX SYSTEMS (LAP) REAGENT KIT K895850 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Dec 1989. https://www.510kdatabase.net/k895393/ 1989-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k895393-sarns-ingant-membrane-oxygenator-fda-510k.jpg K895393 - SARNS INGANT MEMBRANE OXYGENATOR K895393 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: 3M Company. Cleared Dec 1989. https://www.510kdatabase.net/k883400/ 1989-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k883400-optumtm-automated-patient-assist-device-fda-510k.jpg K883400 - OPTUM(TM) AUTOMATED PATIENT ASSIST DEVICE K883400 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Dec 1989. https://www.510kdatabase.net/k895362/ 1989-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k895362-bactec-pyrazinamide-susceptibility-test-fda-510k.jpg K895362 - BACTEC PYRAZINAMIDE SUSCEPTIBILITY TEST K895362 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Dec 1989. https://www.510kdatabase.net/k895809/ 1989-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k895809-mileniatm-hcg-mkcg15-fda-510k.jpg K895809 - MILENIA(TM) HCG (MKCG1,5) K895809 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Dec 1989. https://www.510kdatabase.net/k895870/ 1989-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k895870-isoscreen-ck-confirmatory-kit-fda-510k.jpg K895870 - ISOSCREEN-CK CONFIRMATORY KIT K895870 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Dec 1989. https://www.510kdatabase.net/k896545/ 1989-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k896545-activated-partial-thromboplastin-time-fda-510k.jpg K896545 - ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT) K896545 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Chemical Co.. Cleared Dec 1989. https://www.510kdatabase.net/k895966/ 1989-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k895966-magnetom-m-h-42-63-42-sp-and-63-sp-fda-510k.jpg K895966 - MAGNETOM M, H, 42, 63, 42 SP AND 63 SP K895966 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 1989. https://www.510kdatabase.net/k895422/ 1989-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k895422-tower-self-seal-sterilization-pouch-fda-510k.jpg K895422 - TOWER SELF SEAL STERILIZATION POUCH K895422 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Nov 1989. https://www.510kdatabase.net/k895440/ 1989-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k895440-quinton-mahurkar-catheters-wvitacuff-fda-510k.jpg K895440 - QUINTON MAHURKAR CATHETERS W/VITACUFF K895440 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Nov 1989. https://www.510kdatabase.net/k895851/ 1989-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k895851-synchron-cxr-systems-hdl-cholesterol-fda-510k.jpg K895851 - SYNCHRON CX(R) SYSTEMS HDL CHOLESTEROL REAGENT K895851 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Nov 1989. https://www.510kdatabase.net/k895149/ 1989-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k895149-neocath-1000-umbilical-artery-oxygen-fda-510k.jpg K895149 - NEOCATH 1000 UMBILICAL ARTERY OXYGEN MONITORING SY K895149 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shiley, Inc.. Cleared Nov 1989. https://www.510kdatabase.net/k895150/ 1989-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k895150-continucath-1000-intravascular-oxygen-fda-510k.jpg K895150 - CONTINUCATH 1000 INTRAVASCULAR OXYGEN MONITORING K895150 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shiley, Inc.. Cleared Nov 1989. https://www.510kdatabase.net/k895336/ 1989-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k895336-abbott-inpersol-cycler-1000-fda-510k.jpg K895336 - ABBOTT INPERSOL CYCLER 1000 K895336 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1989. https://www.510kdatabase.net/k896392/ 1989-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k896392-medtronic-epidural-catheter-kit-model-fda-510k.jpg K896392 - MEDTRONIC EPIDURAL CATHETER KIT MODEL 8717 K896392 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Medtronic Vascular. Cleared Nov 1989. https://www.510kdatabase.net/k893793/ 1989-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k893793-tenzcare-electrode-6862-fda-510k.jpg K893793 - TENZCARE ELECTRODE 6862 K893793 is a FDA 510(k) cleared neurology medical device. Manufacturer: 3M Company. Cleared Nov 1989. https://www.510kdatabase.net/k894168/ 1989-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k894168-swan-ganz-therm-cath-sm-heart-amc-fda-510k.jpg K894168 - SWAN-GANZ THERM CATH SM HEART AMC THROM 93A102H5F K894168 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Nov 1989. https://www.510kdatabase.net/k895389/ 1989-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k895389-depuy-tm-true-compression-screw-fda-510k.jpg K895389 - DEPUY (TM) TRUE COMPRESSION SCREW K895389 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Nov 1989. https://www.510kdatabase.net/k894547/ 1989-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k894547-radius-cf-fda-510k.jpg K894547 - RADIUS CF K894547 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Nov 1989. https://www.510kdatabase.net/k896266/ 1989-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k896266-vs22-hip-prosthesis-fda-510k.jpg K896266 - VS22 HIP PROSTHESIS K896266 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 3M Company. Cleared Nov 1989. https://www.510kdatabase.net/k896459/ 1989-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k896459-nova-geltm-t-smrnp-fda-510k.jpg K896459 - NOVA GEL(TM) T SM/RNP K896459 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Nov 1989. https://www.510kdatabase.net/k896460/ 1989-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k896460-nova-geltm-t-ss-ass-b-fda-510k.jpg K896460 - NOVA GEL(TM) T SS-A/SS-B K896460 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Nov 1989. https://www.510kdatabase.net/k896461/ 1989-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k896461-nova-geltm-t-scl-70-fda-510k.jpg K896461 - NOVA GEL(TM) T SCL-70 K896461 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Nov 1989. https://www.510kdatabase.net/k896462/ 1989-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k896462-nova-geltm-t-jo-1-fda-510k.jpg K896462 - NOVA GEL(TM) T JO-1 K896462 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Nov 1989. https://www.510kdatabase.net/k893038/ 1989-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k893038-protofluor-z-fda-510k.jpg K893038 - PROTOFLUOR Z K893038 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Nov 1989. https://www.510kdatabase.net/k895467/ 1989-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k895467-orthophos-and-orthophos-c-fda-510k.jpg K895467 - ORTHOPHOS AND ORTHOPHOS C K895467 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 1989. https://www.510kdatabase.net/k895607/ 1989-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k895607-porous-coated-total-hip-pros-fda-510k.jpg K895607 - POROUS COATED TOTAL HIP PROS. ACETABULAR COMPONENT K895607 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Nov 1989. https://www.510kdatabase.net/k895794/ 1989-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k895794-ge-mr-max-system-fda-510k.jpg K895794 - GE MR MAX SYSTEM K895794 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Nov 1989. https://www.510kdatabase.net/k896074/ 1989-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k896074-vision-phenytoin-fda-510k.jpg K896074 - VISION PHENYTOIN K896074 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1989. https://www.510kdatabase.net/k896434/ 1989-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k896434-auto-suture-surgiport-cannula-diameter-fda-510k.jpg K896434 - AUTO SUTURE SURGIPORT CANNULA DIAMETER REDUCER* K896434 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Nov 1989. https://www.510kdatabase.net/k895204/ 1989-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k895204-epi-cathtm-epidural-catheter-fda-510k.jpg K895204 - EPI-CATH(TM) EPIDURAL CATHETER K895204 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1989. https://www.510kdatabase.net/k895664/ 1989-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k895664-technicon-dax-system-potassium-ise-fda-510k.jpg K895664 - TECHNICON DAX SYSTEM - POTASSIUM (ISE) METHOD K895664 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Nov 1989. https://www.510kdatabase.net/k894328/ 1989-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k894328-tdxr-litestm-lithium-fda-510k.jpg K894328 - TDX(R) LITES(TM) LITHIUM K894328 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1989. https://www.510kdatabase.net/k895251/ 1989-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k895251-bard-intravaginal-stim-kit-wivestm-fda-510k.jpg K895251 - BARD INTRAVAGINAL STIM. KIT W/(IVES(TM)) K895251 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 1989. https://www.510kdatabase.net/k895914/ 1989-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k895914-abbott-imx-ige-fda-510k.jpg K895914 - ABBOTT IMX IGE K895914 is a FDA 510(k) cleared immunology medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1989. https://www.510kdatabase.net/k896092/ 1989-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k896092-alkaline-phosphatase-leukocyte-kit-fda-510k.jpg K896092 - ALKALINE PHOSPHATASE, LEUKOCYTE, KIT K896092 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Chemical Co.. Cleared Nov 1989. https://www.510kdatabase.net/k895766/ 1989-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k895766-asnis-ii-guided-bone-screw-fda-510k.jpg K895766 - ASNIS II GUIDED BONE SCREW K895766 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Nov 1989. https://www.510kdatabase.net/k894142/ 1989-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k894142-ultranet-s-collimator-fda-510k.jpg K894142 - ULTRANET-S COLLIMATOR K894142 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Nov 1989. https://www.510kdatabase.net/k895026/ 1989-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k895026-hp-model-m1318a-transvaginal-fda-510k.jpg K895026 - HP MODEL M1318A TRANSVAGINAL ULTRASOUND TRANSDUCER K895026 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Nov 1989. https://www.510kdatabase.net/k895045/ 1989-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k895045-model-410t-telecommunication-system-fda-510k.jpg K895045 - MODEL 410T TELECOMMUNICATION SYSTEM K895045 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Nov 1989. https://www.510kdatabase.net/k894958/ 1989-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k894958-model-410-alert-and-telecommunication-fda-510k.jpg K894958 - MODEL 410 ALERT AND TELECOMMUNICATION SYSTEM K894958 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Nov 1989. https://www.510kdatabase.net/k895226/ 1989-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k895226-neer-ii-total-shoulder-system-prosthesis-fda-510k.jpg K895226 - NEER II TOTAL SHOULDER SYSTEM & PROSTHESIS K895226 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 3M Company. Cleared Nov 1989. https://www.510kdatabase.net/k895702/ 1989-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k895702-kdr-acetabular-component-fda-510k.jpg K895702 - KDR ACETABULAR COMPONENT K895702 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Nov 1989. https://www.510kdatabase.net/k894292/ 1989-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k894292-bard-liberator-disposable-infusion-fda-510k.jpg K894292 - BARD LIBERATOR DISPOSABLE INFUSION SYSTEM K894292 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 1989. https://www.510kdatabase.net/k893766/ 1989-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k893766-lifecare-cont-epidural-cath-for-fda-510k.jpg K893766 - LIFECARE CONT. EPIDURAL CATH. FOR MORPHINE SULFATE K893766 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1989. https://www.510kdatabase.net/k894940/ 1989-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k894940-datascope-steering-handle-fda-510k.jpg K894940 - DATASCOPE STEERING HANDLE K894940 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Nov 1989. https://www.510kdatabase.net/k893975/ 1989-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k893975-double-antibody-glucagon-fda-510k.jpg K893975 - DOUBLE ANTIBODY GLUCAGON K893975 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Oct 1989. https://www.510kdatabase.net/k894238/ 1989-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k894238-abbott-tdx-total-t3-plus-fda-510k.jpg K894238 - ABBOTT TDX TOTAL T3 PLUS K894238 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1989. https://www.510kdatabase.net/k895005/ 1989-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k895005-mileniatm-fsh-mkfs15-fda-510k.jpg K895005 - MILENIA(TM) FSH (MKFS1,5) K895005 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Oct 1989. https://www.510kdatabase.net/k895249/ 1989-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k895249-systematetm-iron-item-number-65417-fda-510k.jpg K895249 - SYSTEMATE(TM) IRON ITEM NUMBER: 65417 K895249 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Oct 1989. https://www.510kdatabase.net/k895250/ 1989-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k895250-systematetm-alkaline-phosphatase-item-fda-510k.jpg K895250 - SYSTEMATE(TM) ALKALINE PHOSPHATASE ITEM #65402 K895250 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Oct 1989. https://www.510kdatabase.net/k895575/ 1989-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k895575-bio-rad-modular-air-compressor-fda-510k.jpg K895575 - BIO-RAD MODULAR AIR COMPRESSOR K895575 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Bio-Rad. Cleared Oct 1989. https://www.510kdatabase.net/k895723/ 1989-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k895723-irma-counttm-pap-rkpa1-rkpa2-fda-510k.jpg K895723 - IRMA-COUNT(TM) PAP, (RKPA1, RKPA2) K895723 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Oct 1989. https://www.510kdatabase.net/k895868/ 1989-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k895868-heyer-schulte-disposable-peritoneal-fda-510k.jpg K895868 - HEYER-SCHULTE DISPOSABLE PERITONEAL CATHETER PASSE K895868 is a FDA 510(k) cleared neurology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Oct 1989. https://www.510kdatabase.net/k895014/ 1989-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k895014-baxter-baffled-tee-adapter-fda-510k.jpg K895014 - BAXTER BAFFLED TEE ADAPTER K895014 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Oct 1989. https://www.510kdatabase.net/k895151/ 1989-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k895151-vista-mr-2055-hp-system-fda-510k.jpg K895151 - VISTA MR 2055 HP SYSTEM K895151 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Oct 1989. https://www.510kdatabase.net/k895351/ 1989-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k895351-respironics-infant-bageasy-fda-510k.jpg K895351 - RESPIRONICS INFANT BAGEASY K895351 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Oct 1989. https://www.510kdatabase.net/k895388/ 1989-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k895388-shiley-elbow-15mm-swivel-connector-fda-510k.jpg K895388 - SHILEY ELBOW 15MM SWIVEL CONNECTOR K895388 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shiley, Inc.. Cleared Oct 1989. https://www.510kdatabase.net/k895666/ 1989-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k895666-bun-kinetic-fda-510k.jpg K895666 - BUN (KINETIC) K895666 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Oct 1989. https://www.510kdatabase.net/k894941/ 1989-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k894941-coat-a-count-tm-hcg-irma-fda-510k.jpg K894941 - COAT-A-COUNT (TM) HCG IRMA K894941 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Oct 1989. https://www.510kdatabase.net/k894966/ 1989-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k894966-plasma-catecholamines-by-hplc-fda-510k.jpg K894966 - PLASMA CATECHOLAMINES BY HPLC K894966 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Oct 1989. https://www.510kdatabase.net/k895528/ 1989-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k895528-gel-alkaline-phosphatase-isoenzyme-fda-510k.jpg K895528 - GEL ALKALINE PHOSPHATASE ISOENZYME CONTROL NO.5104 K895528 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Oct 1989. https://www.510kdatabase.net/k895672/ 1989-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k895672-technicon-dax-system-sodium-ise-method-fda-510k.jpg K895672 - TECHNICON DAX SYSTEM - SODIUM (ISE) METHOD K895672 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Oct 1989. https://www.510kdatabase.net/k891486/ 1989-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k891486-ar-800pa-respiration-module-fda-510k.jpg K891486 - AR-800PA RESPIRATION MODULE K891486 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Oct 1989. https://www.510kdatabase.net/k895134/ 1989-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k895134-3m-instant-fit-custom-earmold-fda-510k.jpg K895134 - 3M INSTANT FIT CUSTOM EARMOLD K895134 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: 3M Company. Cleared Oct 1989. https://www.510kdatabase.net/k895006/ 1989-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k895006-mileniatm-cortisol-mkco15-fda-510k.jpg K895006 - MILENIA(TM) CORTISOL (MKCO1,5) K895006 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Oct 1989. https://www.510kdatabase.net/k895022/ 1989-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k895022-systemate-creatinine-test-crea-65413-fda-510k.jpg K895022 - SYSTEMATE CREATININE TEST (CREA) #65413 K895022 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Oct 1989. https://www.510kdatabase.net/k895108/ 1989-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k895108-follicle-stimulating-hormone-mab-solid-fda-510k.jpg K895108 - FOLLICLE STIMULATING HORMONE MAB SOLID PHASE COM. K895108 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1989. https://www.510kdatabase.net/k895665/ 1989-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k895665-uric-acid-pap-fda-510k.jpg K895665 - URIC ACID PAP K895665 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Oct 1989. https://www.510kdatabase.net/k882270/ 1989-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k882270-models-27040-27050-conti-flow-fda-510k.jpg K882270 - MODELS 27040 & 27050 CONTI. FLOW RESECTOSCOPES K882270 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Oct 1989. https://www.510kdatabase.net/k894630/ 1989-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k894630-shiley-plexustm-adult-hollow-fiber-fda-510k.jpg K894630 - SHILEY PLEXUS(TM) ADULT HOLLOW FIBER OXYGENATOR K894630 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Oct 1989. https://www.510kdatabase.net/k894658/ 1989-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k894658-kinemax-total-knee-system-femoral-fda-510k.jpg K894658 - KINEMAX TOTAL KNEE SYSTEM FEMORAL SPACERS K894658 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Oct 1989. https://www.510kdatabase.net/k894668/ 1989-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k894668-modified-shiley-therapeutic-fda-510k.jpg K894668 - MODIFIED SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM K894668 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shiley, Inc.. Cleared Oct 1989. https://www.510kdatabase.net/k894632/ 1989-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k894632-model-ssh-140a-ultrasound-imaging-system-fda-510k.jpg K894632 - MODEL SSH-140A ULTRASOUND IMAGING SYSTEM K894632 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Oct 1989. https://www.510kdatabase.net/k895138/ 1989-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k895138-clinistat-ldh-reagent-test-fda-510k.jpg K895138 - CLINISTAT LDH REAGENT TEST K895138 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Oct 1989. https://www.510kdatabase.net/k895395/ 1989-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k895395-v-mueller-rhoton-self-retaining-brain-fda-510k.jpg K895395 - V. MUELLER RHOTON SELF-RETAINING BRAIN RETRACTOR K895395 is a FDA 510(k) cleared neurology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Oct 1989. https://www.510kdatabase.net/k895840/ 1989-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k895840-mileniatm-total-t4-mkt415-fda-510k.jpg K895840 - MILENIA(TM) TOTAL T4 (MKT41,5) K895840 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Oct 1989. https://www.510kdatabase.net/k895861/ 1989-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k895861-delta-techtm-cast-removal-system-fda-510k.jpg K895861 - DELTA-TECH(TM) CAST REMOVAL SYSTEM K895861 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Oct 1989. https://www.510kdatabase.net/k894578/ 1989-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k894578-iq-ldh-fda-510k.jpg K894578 - IQ LDH K894578 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1989. https://www.510kdatabase.net/k894633/ 1989-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k894633-cordis-steerable-coated-guidewire-fda-510k.jpg K894633 - CORDIS STEERABLE COATED GUIDEWIRE K894633 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Oct 1989. https://www.510kdatabase.net/k895047/ 1989-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k895047-clinistat-potassium-reagent-test-fda-510k.jpg K895047 - CLINISTAT POTASSIUM REAGENT TEST K895047 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Oct 1989. https://www.510kdatabase.net/k895118/ 1989-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k895118-systemate-total-bilirubin-catalog-no-fda-510k.jpg K895118 - SYSTEMATE TOTAL BILIRUBIN CATALOG NO. 65407 K895118 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Oct 1989. https://www.510kdatabase.net/k895119/ 1989-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k895119-systemate-direct-bilirubin-catalog-no-fda-510k.jpg K895119 - SYSTEMATE DIRECT BILIRUBIN CATALOG NO. 65406 K895119 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Oct 1989. https://www.510kdatabase.net/k895808/ 1989-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k895808-technicon-dpa-1tm-system-serum-albumin-fda-510k.jpg K895808 - TECHNICON DPA-1(TM) SYSTEM SERUM ALBUMIN K895808 is a FDA 510(k) cleared immunology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Oct 1989. https://www.510kdatabase.net/k893753/ 1989-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k893753-directigen-1-2-3-disseminated-fda-510k.jpg K893753 - DIRECTIGEN 1-2-3 DISSEMINATED CANDIDIASIS TEST K893753 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1989. https://www.510kdatabase.net/k895526/ 1989-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k895526-cobas-ready-glucose-reagent-fda-510k.jpg K895526 - COBAS READY GLUCOSE REAGENT K895526 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Oct 1989. https://www.510kdatabase.net/k894993/ 1989-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k894993-stratusr-total-triiodothyronine-t3-fei-fda-510k.jpg K894993 - STRATUS(R) TOTAL TRIIODOTHYRONINE (T3) F.E.I. K894993 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Oct 1989. https://www.510kdatabase.net/k891992/ 1989-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k891992-tenzcare-stimulator-6890-fda-510k.jpg K891992 - TENZCARE STIMULATOR 6890 K891992 is a FDA 510(k) cleared neurology medical device. Manufacturer: 3M Company. Cleared Oct 1989. https://www.510kdatabase.net/k894318/ 1989-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k894318-datascope-interlock-guide-wire-extension-fda-510k.jpg K894318 - DATASCOPE INTERLOCK GUIDE WIRE EXTENSION K894318 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Oct 1989. https://www.510kdatabase.net/k894496/ 1989-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k894496-olympus-valvulotome-wfixed-tip-fda-510k.jpg K894496 - OLYMPUS VALVULOTOME W/FIXED TIP K894496 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Olympus Corp.. Cleared Oct 1989. https://www.510kdatabase.net/k894681/ 1989-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k894681-revised-labeling-for-arterial-fda-510k.jpg K894681 - REVISED LABELING FOR ARTERIAL EMBOLECTOMY CATHETER K894681 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Oct 1989. https://www.510kdatabase.net/k894694/ 1989-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k894694-omnifit-ceramic-morse-taper-head-fda-510k.jpg K894694 - OMNIFIT CERAMIC MORSE TAPER HEAD K894694 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Oct 1989. https://www.510kdatabase.net/k894732/ 1989-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k894732-vascular-graft-package-shelf-life-fda-510k.jpg K894732 - VASCULAR GRAFT PACKAGE (SHELF-LIFE EXTENSION) K894732 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Oct 1989. https://www.510kdatabase.net/k894976/ 1989-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k894976-alternate-packaging-conf-of-pacemaker-fda-510k.jpg K894976 - ALTERNATE PACKAGING CONF. OF PACEMAKER LEAD ADAP. K894976 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Oct 1989. https://www.510kdatabase.net/k892450/ 1989-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k892450-modified-suture-used-in-catheter-fda-510k.jpg K892450 - MODIFIED SUTURE USED IN CATHETER INSERTION TRAYS K892450 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Quinton, Inc.. Cleared Oct 1989. https://www.510kdatabase.net/k894189/ 1989-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k894189-sceptor-new-antimicrobial-fda-510k.jpg K894189 - SCEPTOR-NEW ANTIMICROBIAL AGENT:TICAR/CLAVU ACID K894189 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1989. https://www.510kdatabase.net/k894580/ 1989-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k894580-gore-tex-surgical-tape-fda-510k.jpg K894580 - GORE-TEX SURGICAL TAPE K894580 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Oct 1989. https://www.510kdatabase.net/k894708/ 1989-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k894708-pt-distal-tip-cement-spacer-fda-510k.jpg K894708 - PT DISTAL TIP CEMENT SPACER K894708 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Oct 1989. https://www.510kdatabase.net/k894247/ 1989-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k894247-periodontal-irrigating-solution-d-fda-510k.jpg K894247 - PERIODONTAL IRRIGATING SOLUTION-D K894247 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Oct 1989. https://www.510kdatabase.net/k894827/ 1989-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k894827-automix-33-compounder-fda-510k.jpg K894827 - AUTOMIX 3+3 COMPOUNDER K894827 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Oct 1989. https://www.510kdatabase.net/k894321/ 1989-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k894321-model-285-infusion-pump-fda-510k.jpg K894321 - MODEL 285 INFUSION PUMP K894321 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Oct 1989. https://www.510kdatabase.net/k894806/ 1989-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k894806-siemens-endo-p-probe-fda-510k.jpg K894806 - SIEMENS ENDO-P-PROBE K894806 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 1989. https://www.510kdatabase.net/k894204/ 1989-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k894204-calcium-arsenazo-iii-reagent-fda-510k.jpg K894204 - CALCIUM (ARSENAZO III) REAGENT K894204 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Oct 1989. https://www.510kdatabase.net/k894320/ 1989-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k894320-model-480-infusion-pump-fda-510k.jpg K894320 - MODEL 480 INFUSION PUMP K894320 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Oct 1989. https://www.510kdatabase.net/k894360/ 1989-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k894360-model-280-infusion-pump-fda-510k.jpg K894360 - MODEL 280 INFUSION PUMP K894360 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Oct 1989. https://www.510kdatabase.net/k894575/ 1989-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k894575-technicon-ra-system-thyroxine-t4-method-fda-510k.jpg K894575 - TECHNICON RA SYSTEM THYROXINE T4 METHOD K894575 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Oct 1989. https://www.510kdatabase.net/k895484/ 1989-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k895484-stratusr-gentamicin-fluorometric-fda-510k.jpg K895484 - STRATUS(R) GENTAMICIN FLUOROMETRIC ENZYME IMMUNO. K895484 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Oct 1989. https://www.510kdatabase.net/k895582/ 1989-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k895582-qclyte-protein-based-ise-control-fda-510k.jpg K895582 - QCLYTE PROTEIN-BASED ISE CONTROL K895582 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Baxter Healthcare Corp. Cleared Oct 1989. https://www.510kdatabase.net/k894394/ 1989-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k894394-abbott-spectrum-glucose-hexokinase-fda-510k.jpg K894394 - ABBOTT SPECTRUM GLUCOSE-HEXOKINASE REAGENT K894394 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1989. https://www.510kdatabase.net/k895221/ 1989-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k895221-addl-options-15-tesla-10-tesla-to-fda-510k.jpg K895221 - ADD'L OPTIONS 1.5 TESLA & 1.0 TESLA TO MAGNETOM 42 K895221 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 1989. https://www.510kdatabase.net/k891451/ 1989-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k891451-olympus-hyf-p-flexible-hysterofiberscope-fda-510k.jpg K891451 - OLYMPUS HYF-P FLEXIBLE HYSTEROFIBERSCOPE K891451 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Olympus Corp.. Cleared Oct 1989. https://www.510kdatabase.net/k894692/ 1989-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k894692-bedside-monitors-bsm-8301a-bsm-8302a-fda-510k.jpg K894692 - BEDSIDE MONITORS, BSM-8301A, BSM-8302A K894692 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Oct 1989. https://www.510kdatabase.net/k894693/ 1989-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k894693-ap-851pa-nibp-module-fda-510k.jpg K894693 - AP-851PA NIBP MODULE K894693 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Oct 1989. https://www.510kdatabase.net/k895158/ 1989-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k895158-vision-whole-blood-hdl-cholesterol-fda-510k.jpg K895158 - VISION WHOLE BLOOD HDL CHOLESTEROL K895158 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1989. https://www.510kdatabase.net/k894756/ 1989-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k894756-denver-peritoneo-venus-shunt-fda-510k.jpg K894756 - DENVER PERITONEO-VENUS SHUNT K894756 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Sep 1989. https://www.510kdatabase.net/k891605/ 1989-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k891605-coat-a-counttm-fentanyl-tkfn1-fda-510k.jpg K891605 - COAT-A-COUNT(TM) FENTANYL (TKFN1) K891605 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Sep 1989. https://www.510kdatabase.net/k892655/ 1989-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k892655-acl-drill-guide-system-fda-510k.jpg K892655 - ACL DRILL GUIDE SYSTEM K892655 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Baxter Healthcare Corp. Cleared Sep 1989. https://www.510kdatabase.net/k894222/ 1989-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k894222-tdxr-analyzer-with-lites-tm-lithium-fda-510k.jpg K894222 - TDXR ANALYZER WITH LITES TM LITHIUM CAROUSEL K894222 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1989. https://www.510kdatabase.net/k894852/ 1989-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k894852-serachem-plus-clinical-chemistry-fda-510k.jpg K894852 - SERACHEM PLUS CLINICAL CHEMISTRY CONTROLS K894852 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 1989. https://www.510kdatabase.net/k895004/ 1989-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k895004-mileniatm-total-ige-mkie15-fda-510k.jpg K895004 - MILENIA(TM) TOTAL IGE (MKIE1,5) K895004 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Sep 1989. https://www.510kdatabase.net/k894298/ 1989-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k894298-modified-gemini-acetabular-cup-fda-510k.jpg K894298 - MODIFIED GEMINI ACETABULAR CUP K894298 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Sep 1989. https://www.510kdatabase.net/k893471/ 1989-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k893471-medtronic-model-9444-teletrace-ii-ecg-fda-510k.jpg K893471 - MEDTRONIC MODEL 9444 TELETRACE II ECG MONITORING K893471 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Sep 1989. https://www.510kdatabase.net/k894182/ 1989-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k894182-imx-total-b-hcg-fda-510k.jpg K894182 - IMX TOTAL B-HCG K894182 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1989. https://www.510kdatabase.net/k894277/ 1989-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k894277-m1400a-transmitterm1402-receiverm1401-fda-510k.jpg K894277 - M1400A TRANSMITTER,M1402 RECEIVER,M1401 MAINFRAME K894277 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Sep 1989. https://www.510kdatabase.net/k894942/ 1989-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k894942-sidewinder-40cc-dl-intra-aortic-fda-510k.jpg K894942 - SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATHETER K894942 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Sep 1989. https://www.510kdatabase.net/k895495/ 1989-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k895495-addl-labeling-to-minix-models-and-fda-510k.jpg K895495 - ADD'L LABELING TO MINIX MODELS AND MINIX ST MODELS K895495 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Sep 1989. https://www.510kdatabase.net/k894407/ 1989-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k894407-abbott-spectrumr-calcium-reagent-fda-510k.jpg K894407 - ABBOTT SPECTRUM(R) CALCIUM REAGENT K894407 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1989. https://www.510kdatabase.net/k895210/ 1989-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k895210-labeling-submittal-adx-fda-510k.jpg K895210 - LABELING SUBMITTAL, ADX AMPHETAMINE/METHAMPHETA.II K895210 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1989. https://www.510kdatabase.net/k893459/ 1989-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k893459-plasma-tfe-vascular-prosthesis-alter-fda-510k.jpg K893459 - PLASMA TFE VASCULAR PROSTHESIS (ALTER. PACKAGE) K893459 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Sep 1989. https://www.510kdatabase.net/k894981/ 1989-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k894981-medtronic-model-5455s-disposable-fda-510k.jpg K894981 - MEDTRONIC MODEL 5455S DISPOSABLE SURGICAL CABLE K894981 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Sep 1989. https://www.510kdatabase.net/k891234/ 1989-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k891234-terufusion-three-way-stopcock-fda-510k.jpg K891234 - TERUFUSION THREE WAY STOPCOCK K891234 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terumo Medical Corp.. Cleared Sep 1989. https://www.510kdatabase.net/k893716/ 1989-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k893716-volumetric-pump-solution-set-for-flo-fda-510k.jpg K893716 - VOLUMETRIC PUMP SOLUTION SET FOR FLO-GARD 8000 K893716 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Sep 1989. https://www.510kdatabase.net/k895003/ 1989-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k895003-mileniatm-prolactin-mkpr15-fda-510k.jpg K895003 - MILENIA(TM) PROLACTIN (MKPR1,5) K895003 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Sep 1989. https://www.510kdatabase.net/k893919/ 1989-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k893919-antec-airway-sampling-device-wmoisture-fda-510k.jpg K893919 - ANTEC AIRWAY SAMPLING DEVICE W/MOISTURE TRAP K893919 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Sep 1989. https://www.510kdatabase.net/k894509/ 1989-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k894509-bicarbonate-test-item-number-65412-fda-510k.jpg K894509 - BICARBONATE TEST ITEM NUMBER: 65412 K894509 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Sep 1989. https://www.510kdatabase.net/k895198/ 1989-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k895198-hall-versipower-surgical-instrument-fda-510k.jpg K895198 - HALL VERSIPOWER SURGICAL INSTRUMENT SYSTEM K895198 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Sep 1989. https://www.510kdatabase.net/k894149/ 1989-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k894149-mod-femoral-com-cluster-patter-outer-fda-510k.jpg K894149 - MOD. FEMORAL COM. & CLUSTER PATTER OUTER SHELL K894149 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Sep 1989. https://www.510kdatabase.net/k892754/ 1989-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k892754-patient-examination-gloves-vinyl-fda-510k.jpg K892754 - PATIENT EXAMINATION GLOVES (VINYL) K892754 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Sep 1989. https://www.510kdatabase.net/k894180/ 1989-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k894180-abbott-ast-activated-liquid-list01a54-fda-510k.jpg K894180 - ABBOTT AST-ACTIVATED (LIQUID, LIST#01A54) K894180 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1989. https://www.510kdatabase.net/k894585/ 1989-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k894585-rep-tm-spe-ponceau-s-procedures-fda-510k.jpg K894585 - REP TM SPE (PONCEAU S) PROCEDURES K894585 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Sep 1989. https://www.510kdatabase.net/k892386/ 1989-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k892386-diagnostic-ultrasound-system-model-ssa-fda-510k.jpg K892386 - DIAGNOSTIC ULTRASOUND SYSTEM: MODEL SSA-250A K892386 is a FDA 510(k) cleared radiology medical device. Manufacturer: Toshiba America Medical Systems, In.C. Cleared Sep 1989. https://www.510kdatabase.net/k894177/ 1989-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k894177-needleless-drug-vial-adapter-fda-510k.jpg K894177 - NEEDLE*LESS DRUG VIAL ADAPTER K894177 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Sep 1989. https://www.510kdatabase.net/k894682/ 1989-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k894682-usci-uncoated-guiding-catheters-fda-510k.jpg K894682 - USCI UNCOATED GUIDING CATHETERS K894682 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Sep 1989. https://www.510kdatabase.net/k893872/ 1989-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k893872-pfc-hip-system-porous-coated-femoral-fda-510k.jpg K893872 - P.F.C. HIP SYSTEM POROUS COATED FEMORAL COMPONENT K893872 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Sep 1989. https://www.510kdatabase.net/k894124/ 1989-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k894124-omnifit-self-tapping-cancellous-bone-fda-510k.jpg K894124 - OMNIFIT SELF TAPPING CANCELLOUS BONE SCREWS K894124 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Sep 1989. https://www.510kdatabase.net/k885168/ 1989-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k885168-rubenstein-ureteral-stone-fragment-brush-fda-510k.jpg K885168 - RUBENSTEIN URETERAL STONE FRAGMENT BRUSH K885168 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Sep 1989. https://www.510kdatabase.net/k893965/ 1989-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k893965-prolong-intravascular-catheter-fda-510k.jpg K893965 - PROLONG INTRAVASCULAR CATHETER K893965 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Sep 1989. https://www.510kdatabase.net/k894063/ 1989-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k894063-triglyceride-gpo-trinder-reagent-fda-510k.jpg K894063 - TRIGLYCERIDE (GPO) TRINDER REAGENT K894063 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Sep 1989. https://www.510kdatabase.net/k894482/ 1989-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k894482-lactate-dehydrogenase-test-ld-item-65418-fda-510k.jpg K894482 - LACTATE DEHYDROGENASE TEST (LD) ITEM #65418 K894482 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Sep 1989. https://www.510kdatabase.net/k894483/ 1989-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k894483-glucose-hk-test-glu-hk-item-65415-fda-510k.jpg K894483 - GLUCOSE-HK TEST (GLU-HK) ITEM #65415 K894483 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Sep 1989. https://www.510kdatabase.net/k894783/ 1989-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k894783-peritoneal-dial-tita-cath-adapter-fda-510k.jpg K894783 - PERITONEAL DIAL. TITA. CATH ADAPTER & LOCKING CAP K894783 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Sep 1989. https://www.510kdatabase.net/k894838/ 1989-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k894838-hemodialysis-single-patient-system-sps-fda-510k.jpg K894838 - HEMODIALYSIS SINGLE PATIENT SYSTEM (SPS) 550 VSB K894838 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Sep 1989. https://www.510kdatabase.net/k893474/ 1989-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k893474-bard-cath-lab-thermodilution-catheter-fda-510k.jpg K893474 - BARD CATH LAB THERMODILUTION CATHETER K893474 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Sep 1989. https://www.510kdatabase.net/k893778/ 1989-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k893778-calcium-test-item-number-65409-fda-510k.jpg K893778 - CALCIUM TEST ITEM NUMBER: 65409 K893778 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Sep 1989. https://www.510kdatabase.net/k894101/ 1989-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k894101-roche-reagent-for-uric-acid-fda-510k.jpg K894101 - ROCHE REAGENT FOR URIC ACID K894101 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Sep 1989. https://www.510kdatabase.net/k894145/ 1989-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k894145-emit-t-uptake-assay-fda-510k.jpg K894145 - EMIT T-UPTAKE ASSAY K894145 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Sep 1989. https://www.510kdatabase.net/k894146/ 1989-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k894146-gram-negative-and-positive-miccombo-fda-510k.jpg K894146 - GRAM NEGATIVE AND POSITIVE MIC/COMBO PANELS K894146 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Sep 1989. https://www.510kdatabase.net/k894148/ 1989-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k894148-mod-femoral-comp-non-beaded-basic-ace-fda-510k.jpg K894148 - MOD. FEMORAL COMP. NON-BEADED & BASIC ACE. SHELL K894148 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Sep 1989. https://www.510kdatabase.net/k894408/ 1989-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k894408-abbott-testpack-plus-hcg-urine-fda-510k.jpg K894408 - ABBOTT TESTPACK PLUS HCG URINE K894408 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1989. https://www.510kdatabase.net/k894467/ 1989-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k894467-thrombin-time-reagent-fda-510k.jpg K894467 - THROMBIN TIME REAGENT K894467 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Chemical Co.. Cleared Sep 1989. https://www.510kdatabase.net/k894718/ 1989-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k894718-adaptaidtm-adapter-sleeve-model-366-33-fda-510k.jpg K894718 - ADAPTAID(TM) ADAPTER SLEEVE MODEL 366-33 K894718 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Sep 1989. https://www.510kdatabase.net/k894269/ 1989-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k894269-ct-hilight-advantage-fda-510k.jpg K894269 - CT HILIGHT ADVANTAGE K894269 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Sep 1989. https://www.510kdatabase.net/k893915/ 1989-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k893915-emds-total-protein-tp-item-number-65420-fda-510k.jpg K893915 - EMDS TOTAL PROTEIN (TP), ITEM NUMBER 65420 K893915 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Aug 1989. https://www.510kdatabase.net/k894022/ 1989-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k894022-patient-examination-gloves-latex-fda-510k.jpg K894022 - PATIENT EXAMINATION GLOVES (LATEX) K894022 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Aug 1989. https://www.510kdatabase.net/k894023/ 1989-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k894023-patient-examination-gloves-vinyl-fda-510k.jpg K894023 - PATIENT EXAMINATION GLOVES (VINYL) K894023 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Aug 1989. https://www.510kdatabase.net/k894081/ 1989-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k894081-rocho-isomune-ld-fda-510k.jpg K894081 - ROCHO ISOMUNE - LD K894081 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Aug 1989. https://www.510kdatabase.net/k894288/ 1989-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k894288-phosphorus-test-item-number-65416-fda-510k.jpg K894288 - PHOSPHORUS TEST ITEM NUMBER 65416 K894288 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Aug 1989. https://www.510kdatabase.net/k894366/ 1989-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k894366-rep-hdl-8-kit-no-3188-rep-hdl-16-kit-fda-510k.jpg K894366 - REP HDL-8 KIT, NO. 3188, REP HDL-16 KIT, NO. 3187 K894366 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Aug 1989. https://www.510kdatabase.net/k894378/ 1989-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k894378-urea-nitrogen-test-bun-item-65408-fda-510k.jpg K894378 - UREA NITROGEN TEST (BUN) ITEM #65408 K894378 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Aug 1989. https://www.510kdatabase.net/k894508/ 1989-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k894508-magnesium-test-item-number-65419-fda-510k.jpg K894508 - MAGNESIUM TEST ITEM NUMBER: 65419 K894508 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Aug 1989. https://www.510kdatabase.net/k894710/ 1989-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k894710-dpc-robostattm-fda-510k.jpg K894710 - DPC-ROBOSTAT(TM) K894710 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Aug 1989. https://www.510kdatabase.net/k893916/ 1989-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k893916-emds-cholesterol-cho-item-number-65410-fda-510k.jpg K893916 - EMDS CHOLESTEROL (CHO), ITEM NUMBER 65410 K893916 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Aug 1989. https://www.510kdatabase.net/k893917/ 1989-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k893917-emds-triglyceride-trig-item-number-65421-fda-510k.jpg K893917 - EMDS TRIGLYCERIDE (TRIG), ITEM NUMBER 65421 K893917 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Aug 1989. https://www.510kdatabase.net/k894207/ 1989-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k894207-ck-mbld-1-control-system-fda-510k.jpg K894207 - CK-MB/LD-1 CONTROL SYSTEM K894207 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Aug 1989. https://www.510kdatabase.net/k894287/ 1989-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k894287-uric-acid-test-item-number-65422-fda-510k.jpg K894287 - URIC ACID TEST ITEM NUMBER 65422 K894287 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Aug 1989. https://www.510kdatabase.net/k894464/ 1989-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k894464-abuscreen-positive-reference-controls-fda-510k.jpg K894464 - ABUSCREEN POSITIVE REFERENCE CONTROLS K894464 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Aug 1989. https://www.510kdatabase.net/k890688/ 1989-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k890688-adx-tm-phencyclidine-fda-510k.jpg K890688 - ADX TM PHENCYCLIDINE K890688 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1989. https://www.510kdatabase.net/k890689/ 1989-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k890689-adx-tm-opiates-fda-510k.jpg K890689 - ADX TM OPIATES K890689 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1989. https://www.510kdatabase.net/k890690/ 1989-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k890690-adx-tm-barbiturates-fda-510k.jpg K890690 - ADX TM BARBITURATES K890690 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1989. https://www.510kdatabase.net/k890691/ 1989-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k890691-adx-tm-benzodiazepines-fda-510k.jpg K890691 - ADX TM BENZODIAZEPINES K890691 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1989. https://www.510kdatabase.net/k890692/ 1989-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k890692-adx-amphetaminemethampheamine-fda-510k.jpg K890692 - ADX AMPHETAMINE/METHAMPHEAMINE K890692 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1989. https://www.510kdatabase.net/k890693/ 1989-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k890693-adx-cannabinoids-fda-510k.jpg K890693 - ADX CANNABINOIDS K890693 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1989. https://www.510kdatabase.net/k890743/ 1989-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k890743-ad-xtm-ethanol-fda-510k.jpg K890743 - AD X(TM) ETHANOL K890743 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1989. https://www.510kdatabase.net/k890788/ 1989-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k890788-adx-cocaine-metabolite-fda-510k.jpg K890788 - ADX COCAINE METABOLITE K890788 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1989. https://www.510kdatabase.net/k893909/ 1989-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k893909-modified-material-used-in-infusion-t-fda-510k.jpg K893909 - MODIFIED MATERIAL USED IN INFUSION T K893909 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Quinton, Inc.. Cleared Aug 1989. https://www.510kdatabase.net/k894055/ 1989-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k894055-minix-8341m-and-minix-st-8331m-pulse-fda-510k.jpg K894055 - MINIX 8341M AND MINIX ST 8331M PULSE GENERATORS K894055 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Aug 1989. https://www.510kdatabase.net/k885018/ 1989-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k885018-absorbable-surgical-gut-suture-fda-510k.jpg K885018 - ABSORBABLE SURGICAL GUT SUTURE* K885018 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Aug 1989. https://www.510kdatabase.net/k891772/ 1989-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k891772-spectinomycin-100-mcg-sensi-disc-fda-510k.jpg K891772 - SPECTINOMYCIN 100 MCG SENSI-DISC K891772 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1989. https://www.510kdatabase.net/k892215/ 1989-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k892215-uni-shunttm-with-elliptical-reservoir-fda-510k.jpg K892215 - UNI-SHUNT(TM) WITH ELLIPTICAL RESERVOIR KIT K892215 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Aug 1989. https://www.510kdatabase.net/k893512/ 1989-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k893512-depuy-cannulated-bone-screw-fda-510k.jpg K893512 - DEPUY CANNULATED BONE SCREW K893512 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Aug 1989. https://www.510kdatabase.net/k893777/ 1989-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k893777-albumin-test-alb-item-number-65401-fda-510k.jpg K893777 - ALBUMIN TEST (ALB) ITEM NUMBER: 65401 K893777 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Aug 1989. https://www.510kdatabase.net/k893910/ 1989-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k893910-emit-convenience-pack-digoxin-assay-fda-510k.jpg K893910 - EMIT CONVENIENCE PACK: DIGOXIN ASSAY K893910 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Aug 1989. https://www.510kdatabase.net/k893912/ 1989-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k893912-technicon-ra-systems-gentamicin-test-fda-510k.jpg K893912 - TECHNICON RA SYSTEMS GENTAMICIN TEST METHOD K893912 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Aug 1989. https://www.510kdatabase.net/k893913/ 1989-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k893913-technicon-ra-systems-tobramycin-test-fda-510k.jpg K893913 - TECHNICON RA SYSTEMS TOBRAMYCIN TEST METHOD K893913 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Aug 1989. https://www.510kdatabase.net/k894069/ 1989-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k894069-abbott-commander-flexible-pipetting-fda-510k.jpg K894069 - ABBOTT COMMANDER FLEXIBLE PIPETTING CENTER K894069 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1989. https://www.510kdatabase.net/k894463/ 1989-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k894463-abuscreen-tri-level-reference-controls-fda-510k.jpg K894463 - ABUSCREEN TRI-LEVEL REFERENCE CONTROLS K894463 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Aug 1989. https://www.510kdatabase.net/k883645/ 1989-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k883645-lifecare-micro-pump-fda-510k.jpg K883645 - LIFECARE MICRO PUMP K883645 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1989. https://www.510kdatabase.net/k890152/ 1989-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k890152-usci-probing-catheter-fda-510k.jpg K890152 - USCI PROBING CATHETER K890152 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Aug 1989. https://www.510kdatabase.net/k890404/ 1989-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k890404-usci-probe-linx-extension-wire-fda-510k.jpg K890404 - USCI PROBE LINX EXTENSION WIRE K890404 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Aug 1989. https://www.510kdatabase.net/k890405/ 1989-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k890405-usci-pta-balloon-dilatation-catheter-fda-510k.jpg K890405 - USCI PTA BALLOON DILATATION CATHETER K890405 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Aug 1989. https://www.510kdatabase.net/k893741/ 1989-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k893741-receptal-r-saf-gardtm-suction-liner-fda-510k.jpg K893741 - RECEPTAL (R) SAF-GARD(TM) SUCTION LINER K893741 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1989. https://www.510kdatabase.net/k893751/ 1989-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k893751-amylase-test-aml-item-number-65404-fda-510k.jpg K893751 - AMYLASE TEST (AML) ITEM NUMBER: 65404 K893751 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Aug 1989. https://www.510kdatabase.net/k893976/ 1989-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k893976-coat-a-count-tm-fsh-irma-fda-510k.jpg K893976 - COAT-A-COUNT (TM) FSH IRMA K893976 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Aug 1989. https://www.510kdatabase.net/k891241/ 1989-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k891241-abbott-spectrum-amylase-reagent-fda-510k.jpg K891241 - ABBOTT SPECTRUM AMYLASE REAGENT K891241 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1989. https://www.510kdatabase.net/k891581/ 1989-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k891581-cobas-fp-reagent-for-valproic-acid-fda-510k.jpg K891581 - COBAS-FP REAGENT FOR VALPROIC ACID & CALIBRATORS K891581 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Aug 1989. https://www.510kdatabase.net/k891999/ 1989-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k891999-chloride-standards-item-sr1041-fda-510k.jpg K891999 - CHLORIDE STANDARDS ITEM #SR1041 K891999 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Aug 1989. https://www.510kdatabase.net/k892801/ 1989-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k892801-clinistat-total-bilirubin-reagent-test-fda-510k.jpg K892801 - CLINISTAT TOTAL BILIRUBIN REAGENT TEST K892801 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Aug 1989. https://www.510kdatabase.net/k893768/ 1989-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k893768-modified-pk300-automatic-eia-analyzer-fda-510k.jpg K893768 - MODIFIED PK300 AUTOMATIC EIA ANALYZER K893768 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Aug 1989. https://www.510kdatabase.net/k893977/ 1989-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k893977-gram-negative-and-positive-miccombo-fda-510k.jpg K893977 - GRAM NEGATIVE AND POSITIVE MIC/COMBO PANELS K893977 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Aug 1989. https://www.510kdatabase.net/k894279/ 1989-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k894279-luteinizing-hormone-mab-solid-phase-fda-510k.jpg K894279 - LUTEINIZING HORMONE MAB SOLID PHASE COMPONENT SYST K894279 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1989. https://www.510kdatabase.net/k894294/ 1989-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k894294-dideco-shiley-universal-y-fda-510k.jpg K894294 - DIDECO-SHILEY UNIVERSAL Y K894294 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shiley, Inc.. Cleared Aug 1989. https://www.510kdatabase.net/k894465/ 1989-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k894465-abuscreen-radioimmunoassay-for-fda-510k.jpg K894465 - ABUSCREEN RADIOIMMUNOASSAY FOR METHAMPHETAMINE K894465 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Aug 1989. https://www.510kdatabase.net/k893509/ 1989-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k893509-ge-signa-advantage-fda-510k.jpg K893509 - GE SIGNA ADVANTAGE K893509 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared Aug 1989. https://www.510kdatabase.net/k893628/ 1989-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k893628-olympus-ise-module-for-au5000-fda-510k.jpg K893628 - OLYMPUS ISE MODULE FOR AU5000 K893628 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Aug 1989. https://www.510kdatabase.net/k893973/ 1989-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k893973-roche-reagent-for-triglycerides-fda-510k.jpg K893973 - ROCHE REAGENT FOR TRIGLYCERIDES K893973 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Aug 1989. https://www.510kdatabase.net/k894078/ 1989-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k894078-lyphochekr-tumor-marker-controls-fda-510k.jpg K894078 - LYPHOCHEK(R) TUMOR MARKER CONTROLS, LEVELS I & II K894078 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Aug 1989. https://www.510kdatabase.net/k894404/ 1989-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k894404-emit-dau-monoclonal-amphetaminemethamphe-fda-510k.jpg K894404 - EMIT D.A.U. MONOCLONAL AMPHETAMINE/METHAMPHETAMINE K894404 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Aug 1989. https://www.510kdatabase.net/k892060/ 1989-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k892060-cyberlab-high-volume-drug-testing-system-fda-510k.jpg K892060 - CYBERLAB HIGH VOLUME DRUG TESTING SYSTEM K892060 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Aug 1989. https://www.510kdatabase.net/k893126/ 1989-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k893126-deseretr-introducer-set-with-vitacuffr-fda-510k.jpg K893126 - DESERET(R) INTRODUCER SET WITH VITACUFF(R) DEVICE K893126 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1989. https://www.510kdatabase.net/k894002/ 1989-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k894002-cytomegalovirus-fluorescent-monoclonal-fda-510k.jpg K894002 - CYTOMEGALOVIRUS FLUORESCENT MONOCLONAL ANTIBODY K894002 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Aug 1989. https://www.510kdatabase.net/k894574/ 1989-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k894574-technicon-dpa-1-system-rf-method-fda-510k.jpg K894574 - TECHNICON DPA-1 SYSTEM RF METHOD K894574 is a FDA 510(k) cleared immunology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Aug 1989. https://www.510kdatabase.net/k885179/ 1989-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k885179-intro-flex-sheath-introducer-wamc-fda-510k.jpg K885179 - INTRO-FLEX SHEATH INTRODUCER W/AMC THROMBOSHIELD K885179 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Aug 1989. https://www.510kdatabase.net/k891069/ 1989-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k891069-usci-coronary-infusion-catheter-fda-510k.jpg K891069 - USCI CORONARY INFUSION CATHETER K891069 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Aug 1989. https://www.510kdatabase.net/k894280/ 1989-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k894280-b-d-patient-examination-gloves-fda-510k.jpg K894280 - B-D PATIENT EXAMINATION GLOVES K894280 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1989. https://www.510kdatabase.net/k892354/ 1989-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k892354-odis-obstetrical-display-info-system-fda-510k.jpg K892354 - ODIS - OBSTETRICAL DISPLAY INFO SYSTEM, HP M1370A K892354 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Aug 1989. https://www.510kdatabase.net/k892884/ 1989-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k892884-medtronic-model-3530-percutaneous-fda-510k.jpg K892884 - MEDTRONIC MODEL 3530 PERCUTANEOUS EXTENSION K892884 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Aug 1989. https://www.510kdatabase.net/k892925/ 1989-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k892925-vecsei-expanding-screw-fda-510k.jpg K892925 - VECSEI EXPANDING SCREW K892925 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Aug 1989. https://www.510kdatabase.net/k893820/ 1989-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k893820-ct-sytec-3000-fda-510k.jpg K893820 - CT SYTEC 3000 K893820 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Aug 1989. https://www.510kdatabase.net/k894072/ 1989-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k894072-the-pudenz-in-line-valve-fda-510k.jpg K894072 - THE PUDENZ IN LINE VALVE K894072 is a FDA 510(k) cleared neurology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Aug 1989. https://www.510kdatabase.net/k893508/ 1989-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k893508-prostate-specific-antigen-fda-510k.jpg K893508 - PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTI K893508 is a FDA 510(k) cleared pathology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Aug 1989. https://www.510kdatabase.net/k894031/ 1989-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k894031-pharmaseal-genetic-amniocentesis-tray-fda-510k.jpg K894031 - PHARMASEAL GENETIC AMNIOCENTESIS TRAY K894031 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Aug 1989. https://www.510kdatabase.net/k891276/ 1989-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k891276-qbc-malaria-system-fda-510k.jpg K891276 - QBC MALARIA SYSTEM K891276 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1989. https://www.510kdatabase.net/k891580/ 1989-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k891580-intravascular-catheter-with-fda-510k.jpg K891580 - INTRAVASCULAR CATHETER WITH HYDROPHILIC COATING K891580 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Aug 1989. https://www.510kdatabase.net/k892800/ 1989-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k892800-mg-ii-porous-total-knee-system-fda-510k.jpg K892800 - MG II POROUS TOTAL KNEE SYSTEM K892800 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Aug 1989. https://www.510kdatabase.net/k893403/ 1989-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k893403-models-hp-43110mc-43200mc-wcase-43200m-fda-510k.jpg K893403 - MODELS HP 43110MC, 43200MC W/CASE & 43200M NO CASE K893403 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Aug 1989. https://www.510kdatabase.net/k893547/ 1989-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k893547-clinimate-tda-blood-chemistry-analyzer-fda-510k.jpg K893547 - CLINIMATE-TDA BLOOD CHEMISTRY ANALYZER K893547 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Aug 1989. https://www.510kdatabase.net/k893548/ 1989-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k893548-seralyzer-hdl-cholesterol-procedure-fda-510k.jpg K893548 - SERALYZER HDL CHOLESTEROL PROCEDURE USE W/STRIP K893548 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Aug 1989. https://www.510kdatabase.net/k893577/ 1989-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k893577-status-hcg-fluorometric-enzyme-fda-510k.jpg K893577 - STATUS HCG FLUOROMETRIC ENZYME K893577 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Baxter Healthcare Corp. Cleared Aug 1989. https://www.510kdatabase.net/k893639/ 1989-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k893639-gamma-locking-nail-fda-510k.jpg K893639 - GAMMA LOCKING NAIL K893639 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Aug 1989. https://www.510kdatabase.net/k893683/ 1989-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k893683-sarns-pressure-adjustable-safety-system-fda-510k.jpg K893683 - SARNS PRESSURE ADJUSTABLE SAFETY SYSTEM K893683 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: 3M Company. Cleared Aug 1989. https://www.510kdatabase.net/k893715/ 1989-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k893715-ethicon-disposable-surgical-trocar-fda-510k.jpg K893715 - ETHICON DISPOSABLE SURGICAL TROCAR K893715 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ethicon, Inc.. Cleared Aug 1989. https://www.510kdatabase.net/k893776/ 1989-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k893776-abbott-asset-automated-clinical-fda-510k.jpg K893776 - ABBOTT ASSET AUTOMATED CLINICAL CHEMISTRY ANALYZER K893776 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1989. https://www.510kdatabase.net/k893854/ 1989-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k893854-cobas-fara-ii-centrifugal-analyzer-fda-510k.jpg K893854 - COBAS FARA II CENTRIFUGAL ANALYZER K893854 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Aug 1989. https://www.510kdatabase.net/k893855/ 1989-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k893855-abuscreen-ontrak-pos-ref-control-for-fda-510k.jpg K893855 - ABUSCREEN ONTRAK POS. REF. CONTROL FOR BARBITUATES K893855 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Aug 1989. https://www.510kdatabase.net/k893856/ 1989-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k893856-abuscreen-ontrak-pos-ref-control-for-fda-510k.jpg K893856 - ABUSCREEN ONTRAK POS. REF. CONTROL FOR MORPHINE K893856 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Aug 1989. https://www.510kdatabase.net/k893857/ 1989-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k893857-abuscreen-ontrak-pos-ref-control-for-fda-510k.jpg K893857 - ABUSCREEN ONTRAK POS. REF. CONTROL FOR AMPHETAMINE K893857 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Aug 1989. https://www.510kdatabase.net/k893858/ 1989-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k893858-abuscreen-ontrak-pos-reference-control-fda-510k.jpg K893858 - ABUSCREEN ONTRAK POS. REFERENCE CONTROL FOR THC K893858 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Aug 1989. https://www.510kdatabase.net/k893859/ 1989-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k893859-abuscreen-ontrak-pos-ref-control-for-fda-510k.jpg K893859 - ABUSCREEN ONTRAK POS. REF. CONTROL FOR COCAINE K893859 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Aug 1989. https://www.510kdatabase.net/k893860/ 1989-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k893860-abuscreen-ontrak-posrefcontrol-for-fda-510k.jpg K893860 - ABUSCREEN ONTRAK POS.REF.CONTROL FOR PHENCYCLIDINE K893860 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Aug 1989. https://www.510kdatabase.net/k893905/ 1989-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k893905-pathodxtm-chlamydia-direct-specimen-fda-510k.jpg K893905 - PATHODX(TM) CHLAMYDIA DIRECT SPECIMEN (PDCY1) K893905 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Aug 1989. https://www.510kdatabase.net/k893961/ 1989-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k893961-abbott-imxtm-d-dimer-fda-510k.jpg K893961 - ABBOTT IMX(TM) D-DIMER K893961 is a FDA 510(k) cleared hematology medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1989. https://www.510kdatabase.net/k894327/ 1989-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k894327-emit-dau-low-medium-calibrator-a-fda-510k.jpg K894327 - EMIT D.A.U. LOW & MEDIUM CALIBRATOR A K894327 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Aug 1989. https://www.510kdatabase.net/k891013/ 1989-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k891013-medtronic-intravascular-blood-gas-fda-510k.jpg K891013 - MEDTRONIC INTRAVASCULAR BLOOD GAS MONITORING K891013 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Medtronic Vascular. Cleared Aug 1989. https://www.510kdatabase.net/k893640/ 1989-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k893640-software-version-d13-and-a13-for-fda-510k.jpg K893640 - SOFTWARE VERSION, D1.3 AND A1.3 FOR MAGNETOM K893640 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 1989. https://www.510kdatabase.net/k884802/ 1989-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k884802-cavendish-460680-anesthesia-machine-fda-510k.jpg K884802 - CAVENDISH 460/680 ANESTHESIA MACHINE K884802 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Dentsply Intl.. Cleared Aug 1989. https://www.510kdatabase.net/k891475/ 1989-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k891475-lyphochekr-immunoassay-contr-serum-fda-510k.jpg K891475 - LYPHOCHEK(R) IMMUNOASSAY CONTR SERUM (HUMAN) 1,2,3 K891475 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Aug 1989. https://www.510kdatabase.net/k893578/ 1989-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k893578-pharmaseal-medi-vac-sterile-post-op-fda-510k.jpg K893578 - PHARMASEAL MEDI-VAC STERILE POST-OP AUTOTRANS. SYS K893578 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Aug 1989. https://www.510kdatabase.net/k894252/ 1989-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k894252-lyphochek-immunoassay-plus-control-serum-fda-510k.jpg K894252 - LYPHOCHEK IMMUNOASSAY PLUS CONTROL SERUM K894252 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Aug 1989. https://www.510kdatabase.net/k893487/ 1989-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k893487-lifecare-75-controller-fda-510k.jpg K893487 - LIFECARE 75 CONTROLLER K893487 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Jul 1989. https://www.510kdatabase.net/k892930/ 1989-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k892930-technicon-dax-tm-system-additional-fda-510k.jpg K892930 - TECHNICON DAX TM SYSTEM ADDITIONAL ANALYTES K892930 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Jul 1989. https://www.510kdatabase.net/k894140/ 1989-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k894140-medtronic-model-9443-in-office-fda-510k.jpg K894140 - MEDTRONIC MODEL 9443 IN-OFFICE TRANSMITTER K894140 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jul 1989. https://www.510kdatabase.net/k892906/ 1989-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k892906-60-microbore-extension-set-wanti-fda-510k.jpg K892906 - 60 MICROBORE EXTENSION SET W/ANTI-SIPHON VALVE K892906 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jul 1989. https://www.510kdatabase.net/k893676/ 1989-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k893676-abbott-testpack-chlamydia-fda-510k.jpg K893676 - ABBOTT TESTPACK CHLAMYDIA K893676 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Jul 1989. https://www.510kdatabase.net/k893775/ 1989-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k893775-du-pont-dimension-psid-clinical-fda-510k.jpg K893775 - DU PONT DIMENSION PSID CLINICAL CHEMISTRY SYSTEM K893775 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Jul 1989. https://www.510kdatabase.net/k892355/ 1989-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k892355-m1300a-ultrasound-imaging-system-fda-510k.jpg K892355 - M1300A ULTRASOUND IMAGING SYSTEM, M1321A 3.5 MHZ K892355 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Jul 1989. https://www.510kdatabase.net/k890194/ 1989-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k890194-shiley-specialized-tracheostomy-tube-fda-510k.jpg K890194 - SHILEY SPECIALIZED TRACHEOSTOMY TUBE K890194 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shiley, Inc.. Cleared Jul 1989. https://www.510kdatabase.net/k892410/ 1989-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k892410-fogartyr-thru-lumen-embolectomy-catheter-fda-510k.jpg K892410 - FOGARTY(R) THRU-LUMEN EMBOLECTOMY CATHETER K892410 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jul 1989. https://www.510kdatabase.net/k892848/ 1989-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k892848-pancreatic-a-amylase-pnp-fda-510k.jpg K892848 - PANCREATIC A-AMYLASE PNP K892848 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jul 1989. https://www.510kdatabase.net/k892929/ 1989-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k892929-technicon-axon-tm-system-additional-fda-510k.jpg K892929 - TECHNICON AXON TM SYSTEM ADDITIONAL ANALYTES K892929 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Jul 1989. https://www.510kdatabase.net/k893007/ 1989-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k893007-reptm-ck-2-stat-kit-cat-no-3074-fda-510k.jpg K893007 - REP(TM) CK-2 STAT KIT, CAT. NO. 3074 K893007 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Jul 1989. https://www.510kdatabase.net/k893269/ 1989-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k893269-beckman-paragontm-creatine-kinase-fda-510k.jpg K893269 - BECKMAN PARAGON(TM) CREATINE KINASE ISOENZYME K893269 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jul 1989. https://www.510kdatabase.net/k893560/ 1989-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k893560-alt-reagent-procedure-number-159-fda-510k.jpg K893560 - ALT REAGENT (PROCEDURE NUMBER 159) K893560 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Jul 1989. https://www.510kdatabase.net/k893580/ 1989-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k893580-dade-lipid-trol-fda-510k.jpg K893580 - DADE LIPID-TROL K893580 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jul 1989. https://www.510kdatabase.net/k893641/ 1989-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k893641-cobas-fara-centrifugal-analyzer-fda-510k.jpg K893641 - COBAS FARA CENTRIFUGAL ANALYZER K893641 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jul 1989. https://www.510kdatabase.net/k893689/ 1989-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k893689-vision-integrated-performance-option-fda-510k.jpg K893689 - VISION INTEGRATED PERFORMANCE OPTION K893689 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 1989. https://www.510kdatabase.net/k893752/ 1989-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k893752-alanine-aminotransferase-test-alt-item-fda-510k.jpg K893752 - ALANINE AMINOTRANSFERASE TEST (ALT) ITEM # 65403 K893752 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jul 1989. https://www.510kdatabase.net/k893765/ 1989-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k893765-gamma-glutamyl-transferase-test-item-fda-510k.jpg K893765 - GAMMA GLUTAMYL TRANSFERASE TEST, ITEM: 65414/R1 K893765 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jul 1989. https://www.510kdatabase.net/k892394/ 1989-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k892394-pfc-modular-knee-system-tibial-tray-fda-510k.jpg K892394 - P.F.C. MODULAR KNEE SYSTEM, TIBIAL TRAY-POROUS K892394 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jul 1989. https://www.510kdatabase.net/k884505/ 1989-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k884505-basalbolus-infusors-fda-510k.jpg K884505 - BASAL/BOLUS INFUSORS K884505 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jul 1989. https://www.510kdatabase.net/k891791/ 1989-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k891791-accu-touch-latex-exam-gloves-unisize-fda-510k.jpg K891791 - ACCU-TOUCH LATEX EXAM GLOVES, UNISIZE & LARGE K891791 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Jul 1989. https://www.510kdatabase.net/k891948/ 1989-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k891948-tru-touch-vinyl-exam-gloves-belgium-fda-510k.jpg K891948 - TRU-TOUCH VINYL EXAM GLOVES (BELGIUM) K891948 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jul 1989. https://www.510kdatabase.net/k892075/ 1989-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k892075-medline-latex-exam-gloves-fda-510k.jpg K892075 - MEDLINE LATEX EXAM GLOVES K892075 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Jul 1989. https://www.510kdatabase.net/k892446/ 1989-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k892446-shiley-equipment-support-carts-esc-002-fda-510k.jpg K892446 - SHILEY EQUIPMENT SUPPORT CARTS ESC-002 & ESCB-02 K892446 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Jul 1989. https://www.510kdatabase.net/k892750/ 1989-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k892750-patient-examination-gloves-latex-fda-510k.jpg K892750 - PATIENT EXAMINATION GLOVES (LATEX) K892750 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jul 1989. https://www.510kdatabase.net/k892751/ 1989-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k892751-patient-examination-gloves-dental-fda-510k.jpg K892751 - PATIENT EXAMINATION GLOVES (DENTAL) K892751 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jul 1989. https://www.510kdatabase.net/k893562/ 1989-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k893562-aqc-hct-level-1-and-2-fda-510k.jpg K893562 - A.QC HCT LEVEL 1 AND 2 K893562 is a FDA 510(k) cleared hematology medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jul 1989. https://www.510kdatabase.net/k893566/ 1989-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k893566-argenco-50-type-iv-type-iv-dental-gold-fda-510k.jpg K893566 - ARGENCO 50 TYPE IV TYPE IV DENTAL GOLD ALLOY K893566 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jul 1989. https://www.510kdatabase.net/k893675/ 1989-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k893675-vista-mr-2055-hp-system-and-2055-fda-510k.jpg K893675 - VISTA MR 2055 HP SYSTEM AND 2055 UPGRADES K893675 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Jul 1989. https://www.510kdatabase.net/k893739/ 1989-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k893739-vista-mr-2055-hp-system-and-2055-fda-510k.jpg K893739 - VISTA MR 2055 HP SYSTEM AND 2055 UPGRADES K893739 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Jul 1989. https://www.510kdatabase.net/k893754/ 1989-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k893754-cefixime-5-mcg-sensi-disc-antimic-fda-510k.jpg K893754 - CEFIXIME, 5 MCG SENSI-DISC ANTIMIC SUSCEP TEST DIS K893754 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jul 1989. https://www.510kdatabase.net/k894040/ 1989-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k894040-implantable-pacing-leads-wis-1-conn-fda-510k.jpg K894040 - IMPLANTABLE PACING LEADS W/IS-1 CONN., UNIPOLAR K894040 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jul 1989. https://www.510kdatabase.net/k885295/ 1989-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k885295-imx-rubella-igm-micropart-enzyme-fda-510k.jpg K885295 - IMX RUBELLA IGM, MICROPART. ENZYME IMMUNOASSAY K885295 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1989. https://www.510kdatabase.net/k885297/ 1989-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k885297-imx-rubella-igg-microparticle-enzyme-fda-510k.jpg K885297 - IMX RUBELLA IGG, MICROPARTICLE ENZYME IMMUNOASSAY K885297 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1989. https://www.510kdatabase.net/k890031/ 1989-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k890031-imx-toxo-igg-antibody-assay-fda-510k.jpg K890031 - IMX TOXO IGG ANTIBODY ASSAY K890031 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1989. https://www.510kdatabase.net/k890032/ 1989-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k890032-imx-toxo-igm-antibody-assay-fda-510k.jpg K890032 - IMX TOXO IGM ANTIBODY ASSAY K890032 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1989. https://www.510kdatabase.net/k891063/ 1989-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k891063-surflor-winged-infusion-set-fda-510k.jpg K891063 - SURFLO(R) WINGED INFUSION SET K891063 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terumo Medical Corp.. Cleared Jun 1989. https://www.510kdatabase.net/k891087/ 1989-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k891087-terumo-surflor-iv-catheter-fda-510k.jpg K891087 - TERUMO SURFLO(R) I.V. CATHETER K891087 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terumo Medical Corp.. Cleared Jun 1989. https://www.510kdatabase.net/k891146/ 1989-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k891146-terumo-surflor-injection-plug-fda-510k.jpg K891146 - TERUMO SURFLO(R) INJECTION PLUG K891146 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terumo Medical Corp.. Cleared Jun 1989. https://www.510kdatabase.net/k891456/ 1989-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k891456-heyer-schulte-csf-ventri-fda-510k.jpg K891456 - HEYER-SCHULTE (CSF) VENTRI ACCESS(RESERV/ANTECHAM K891456 is a FDA 510(k) cleared neurology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jun 1989. https://www.510kdatabase.net/k892860/ 1989-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k892860-saturne-41-fda-510k.jpg K892860 - SATURNE 41 K892860 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jun 1989. https://www.510kdatabase.net/k893416/ 1989-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k893416-uric-acid-reagent-procedure-number-686-fda-510k.jpg K893416 - URIC ACID REAGENT (PROCEDURE NUMBER 686) K893416 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Jun 1989. https://www.510kdatabase.net/k893420/ 1989-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k893420-masterlab-pft-and-masterlab-body-box-fda-510k.jpg K893420 - MASTERLAB PFT AND MASTERLAB BODY BOX K893420 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Quinton, Inc.. Cleared Jun 1989. https://www.510kdatabase.net/k893510/ 1989-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k893510-cronex-quanta-v-rare-earth-fda-510k.jpg K893510 - CRONEX QUANTA V RARE EARTH INTENSIFYING SCREEN K893510 is a FDA 510(k) cleared radiology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Jun 1989. https://www.510kdatabase.net/k893565/ 1989-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k893565-argenco-68-type-iv-dental-gold-alloy-fda-510k.jpg K893565 - ARGENCO 68 TYPE IV DENTAL GOLD ALLOY K893565 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jun 1989. https://www.510kdatabase.net/k893568/ 1989-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k893568-argenco-56-type-iv-dental-gold-alloy-fda-510k.jpg K893568 - ARGENCO 56 TYPE IV DENTAL GOLD ALLOY K893568 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jun 1989. https://www.510kdatabase.net/k893619/ 1989-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k893619-vista-mr-2055-hp-system-fda-510k.jpg K893619 - VISTA MR 2055 HP SYSTEM K893619 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Jun 1989. https://www.510kdatabase.net/k893686/ 1989-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k893686-argeloy-np-fda-510k.jpg K893686 - ARGELOY N.P. K893686 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jun 1989. https://www.510kdatabase.net/k893787/ 1989-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k893787-lifecell-recovery-container-fda-510k.jpg K893787 - LIFECELL RECOVERY CONTAINER K893787 is a FDA 510(k) cleared pathology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jun 1989. https://www.510kdatabase.net/k885102/ 1989-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k885102-omnifit-ceramic-morse-taper-head-1002-fda-510k.jpg K885102 - OMNIFIT CERAMIC MORSE TAPER HEAD (1002 SERIES) K885102 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Jun 1989. https://www.510kdatabase.net/k891062/ 1989-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k891062-terumo-av-fistula-needle-set-fda-510k.jpg K891062 - TERUMO AV FISTULA NEEDLE SET K891062 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Terumo Medical Corp.. Cleared Jun 1989. https://www.510kdatabase.net/k891952/ 1989-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k891952-tru-touch-vinyl-exam-gloves-canada-fda-510k.jpg K891952 - TRU-TOUCH VINYL EXAM GLOVES (CANADA) K891952 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jun 1989. https://www.510kdatabase.net/k892937/ 1989-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k892937-reusable-bowl-and-spatula-for-mixing-fda-510k.jpg K892937 - REUSABLE BOWL AND SPATULA FOR MIXING BONE CEMENTS K892937 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Dentsply Intl.. Cleared Jun 1989. https://www.510kdatabase.net/k893031/ 1989-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k893031-delta-tm-robotic-pipettor-fda-510k.jpg K893031 - DELTA (TM) ROBOTIC PIPETTOR K893031 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jun 1989. https://www.510kdatabase.net/k890505/ 1989-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k890505-usci-greyblack-guide-wire-fda-510k.jpg K890505 - USCI GREY/BLACK GUIDE WIRE K890505 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jun 1989. https://www.510kdatabase.net/k890807/ 1989-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k890807-guide-wire-introducer-fda-510k.jpg K890807 - GUIDE WIRE INTRODUCER K890807 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Jun 1989. https://www.510kdatabase.net/k890827/ 1989-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k890827-il1400-bgelectrolyte-analyzer-fda-510k.jpg K890827 - IL1400, BGELECTROLYTE ANALYZER K890827 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jun 1989. https://www.510kdatabase.net/k892818/ 1989-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k892818-reptm-ld-2-stat-kit-cat-no-3078-fda-510k.jpg K892818 - REP(TM) LD-2 STAT KIT, CAT. NO. 3078 K892818 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Jun 1989. https://www.510kdatabase.net/k892844/ 1989-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k892844-ast-reagent-procedure-number-158-fda-510k.jpg K892844 - AST REAGENT (PROCEDURE NUMBER 158) K892844 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Jun 1989. https://www.510kdatabase.net/k893224/ 1989-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k893224-rep-glyco-8-kit-3208rep-glyco-16-kit-fda-510k.jpg K893224 - REP GLYCO-8 KIT, #3208/REP GLYCO-16 KIT, #3207 K893224 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Jun 1989. https://www.510kdatabase.net/k893243/ 1989-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k893243-intra-aortic-balloon-fda-510k.jpg K893243 - INTRA AORTIC BALLOON K893243 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Jun 1989. https://www.510kdatabase.net/k893392/ 1989-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k893392-cpm-1-system-oximetercardiac-output-fda-510k.jpg K893392 - CPM-1 SYSTEM OXIMETER/CARDIAC OUTPUT COMPUTER K893392 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jun 1989. https://www.510kdatabase.net/k893423/ 1989-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k893423-qbc-iii-centrifugal-hematology-system-fda-510k.jpg K893423 - QBC III CENTRIFUGAL HEMATOLOGY SYSTEM K893423 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jun 1989. https://www.510kdatabase.net/k893554/ 1989-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k893554-argenco-60-type-iv-dental-gold-alloy-fda-510k.jpg K893554 - ARGENCO 60 TYPE IV DENTAL GOLD ALLOY K893554 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jun 1989. https://www.510kdatabase.net/k893563/ 1989-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k893563-argenco-42-type-iv-dental-gold-alloy-fda-510k.jpg K893563 - ARGENCO 42 TYPE IV DENTAL GOLD ALLOY K893563 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jun 1989. https://www.510kdatabase.net/k893564/ 1989-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k893564-argenco-30-type-iv-dental-gold-alloy-fda-510k.jpg K893564 - ARGENCO 30 TYPE IV DENTAL GOLD ALLOY K893564 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jun 1989. https://www.510kdatabase.net/k893567/ 1989-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k893567-argenco-52-type-iv-dental-gold-alloy-fda-510k.jpg K893567 - ARGENCO 52 TYPE IV DENTAL GOLD ALLOY K893567 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jun 1989. https://www.510kdatabase.net/k893633/ 1989-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k893633-model-5330-external-a-v-sequential-fda-510k.jpg K893633 - MODEL 5330 EXTERNAL A-V SEQUENTIAL DEMAND PULSE K893633 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jun 1989. https://www.510kdatabase.net/k893211/ 1989-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k893211-rep-spe-8-kit-cat-3172rep-spe-16-kit-fda-510k.jpg K893211 - REP SPE-8 KIT, CAT.# 3172/REP SPE-16 KIT CAT.#3171 K893211 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Jun 1989. https://www.510kdatabase.net/k891270/ 1989-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k891270-microtrak-eia-autoreader-fda-510k.jpg K891270 - MICROTRAK EIA AUTOREADER K891270 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Jun 1989. https://www.510kdatabase.net/k892838/ 1989-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k892838-iron-system-pack-reagents-fda-510k.jpg K892838 - IRON SYSTEM PACK REAGENTS K892838 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jun 1989. https://www.510kdatabase.net/k893125/ 1989-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k893125-beckman-epsilontm-ige-reagent-kit-fda-510k.jpg K893125 - BECKMAN EPSILON(TM) IGE REAGENT KIT K893125 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jun 1989. https://www.510kdatabase.net/k891690/ 1989-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k891690-kodak-ektascan-image-manager-fda-510k.jpg K891690 - KODAK EKTASCAN IMAGE MANAGER K891690 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Jun 1989. https://www.510kdatabase.net/k891769/ 1989-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k891769-magniscan-5000-mr-system-fda-510k.jpg K891769 - MAGNISCAN 5000 MR SYSTEM K891769 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jun 1989. https://www.510kdatabase.net/k892052/ 1989-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k892052-sarns-medical-cart-fda-510k.jpg K892052 - SARNS MEDICAL CART K892052 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3M Company. Cleared Jun 1989. https://www.510kdatabase.net/k893707/ 1989-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k893707-auto-suture-surgiport-depth-guide-and-fda-510k.jpg K893707 - AUTO SUTURE SURGIPORT DEPTH GUIDE AND SKIRT K893707 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Jun 1989. https://www.510kdatabase.net/k891600/ 1989-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k891600-argedent-88-dental-alloy-for-porcelain-fda-510k.jpg K891600 - ARGEDENT 88, DENTAL ALLOY FOR PORCELAIN) K891600 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jun 1989. https://www.510kdatabase.net/k892910/ 1989-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k892910-argelite-76sf-dental-alloy-fda-510k.jpg K892910 - ARGELITE 76SF+ DENTAL ALLOY K892910 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jun 1989. https://www.510kdatabase.net/k893345/ 1989-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k893345-argelite-50-dental-alloy-for-porcelain-fda-510k.jpg K893345 - ARGELITE 50 (DENTAL ALLOY FOR PORCELAIN APPLI.) K893345 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jun 1989. https://www.510kdatabase.net/k893381/ 1989-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k893381-argenco-71-type-ii-dental-gold-alloy-fda-510k.jpg K893381 - ARGENCO 71 TYPE II DENTAL GOLD ALLOY K893381 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jun 1989. https://www.510kdatabase.net/k893382/ 1989-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k893382-argenco-63-type-iii-dental-gold-alloy-fda-510k.jpg K893382 - ARGENCO 63 TYPE III DENTAL GOLD ALLOY K893382 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jun 1989. https://www.510kdatabase.net/k893383/ 1989-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k893383-argenco-75-type-iii-dental-gold-alloy-fda-510k.jpg K893383 - ARGENCO 75 TYPE III DENTAL GOLD ALLOY K893383 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jun 1989. https://www.510kdatabase.net/k893384/ 1989-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k893384-argenco-83-type-i-dental-gold-alloy-fda-510k.jpg K893384 - ARGENCO 83 TYPE I DENTAL GOLD ALLOY K893384 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jun 1989. https://www.510kdatabase.net/k893385/ 1989-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k893385-argenco-77-type-ii-dental-gold-alloy-fda-510k.jpg K893385 - ARGENCO 77 TYPE II DENTAL GOLD ALLOY K893385 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jun 1989. https://www.510kdatabase.net/k893386/ 1989-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k893386-argenco-62-type-iii-dental-gold-alloy-fda-510k.jpg K893386 - ARGENCO 62 TYPE III DENTAL GOLD ALLOY K893386 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jun 1989. https://www.510kdatabase.net/k893413/ 1989-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k893413-argenco-40-type-iii-dental-gold-alloy-fda-510k.jpg K893413 - ARGENCO 40 TYPE III DENTAL GOLD ALLOY K893413 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jun 1989. https://www.510kdatabase.net/k893434/ 1989-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k893434-argenco-20-type-iii-dental-gold-alloy-fda-510k.jpg K893434 - ARGENCO 20 TYPE III DENTAL GOLD ALLOY K893434 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jun 1989. https://www.510kdatabase.net/k893441/ 1989-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k893441-argenco-50-type-iii-dental-gold-alloy-fda-510k.jpg K893441 - ARGENCO 50 TYPE III DENTAL GOLD ALLOY K893441 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jun 1989. https://www.510kdatabase.net/k893442/ 1989-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k893442-argenco-58-type-iii-dental-gold-alloy-fda-510k.jpg K893442 - ARGENCO 58 TYPE III DENTAL GOLD ALLOY K893442 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jun 1989. https://www.510kdatabase.net/k893443/ 1989-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k893443-argenco-60-type-iii-dental-gold-alloy-fda-510k.jpg K893443 - ARGENCO 60 TYPE III DENTAL GOLD ALLOY K893443 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jun 1989. https://www.510kdatabase.net/k893444/ 1989-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k893444-argenco-46-type-iii-dental-gold-alloy-fda-510k.jpg K893444 - ARGENCO 46 TYPE III DENTAL GOLD ALLOY K893444 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jun 1989. https://www.510kdatabase.net/k891680/ 1989-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k891680-lyphochek-tumor-marker-controls-levels-fda-510k.jpg K891680 - LYPHOCHEK TUMOR MARKER CONTROLS, LEVELS I AND II K891680 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Jun 1989. https://www.510kdatabase.net/k892928/ 1989-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k892928-haemophilus-test-medium-agar-fda-510k.jpg K892928 - HAEMOPHILUS TEST MEDIUM (AGAR) K892928 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Jun 1989. https://www.510kdatabase.net/k890800/ 1989-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k890800-rotating-hemostatic-valve-fda-510k.jpg K890800 - ROTATING HEMOSTATIC VALVE K890800 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Jun 1989. https://www.510kdatabase.net/k891408/ 1989-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k891408-modified-profile-hip-acetabular-fda-510k.jpg K891408 - MODIFIED PROFILE HIP ACETABULAR PROSTHESIS K891408 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jun 1989. https://www.510kdatabase.net/k891595/ 1989-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k891595-model-116-fetal-monitor-fda-510k.jpg K891595 - MODEL 116 FETAL MONITOR K891595 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Jun 1989. https://www.510kdatabase.net/k892811/ 1989-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k892811-argelite-54b-fda-510k.jpg K892811 - ARGELITE 54B K892811 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jun 1989. https://www.510kdatabase.net/k893227/ 1989-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k893227-argenco-w-fda-510k.jpg K893227 - ARGENCO W+ K893227 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jun 1989. https://www.510kdatabase.net/k891082/ 1989-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k891082-ceramic-total-hip-ball-head-large-taper-fda-510k.jpg K891082 - CERAMIC TOTAL HIP BALL HEAD, LARGE TAPER K891082 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jun 1989. https://www.510kdatabase.net/k891083/ 1989-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k891083-ceramic-total-hip-ball-head-small-taper-fda-510k.jpg K891083 - CERAMIC TOTAL HIP BALL HEAD, SMALL TAPER K891083 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jun 1989. https://www.510kdatabase.net/k891288/ 1989-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k891288-tegasorbtm-ulcer-dressing-90-xxx-fda-510k.jpg K891288 - TEGASORB(TM) ULCER DRESSING, #90-XXX K891288 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3M Company. Cleared Jun 1989. https://www.510kdatabase.net/k891477/ 1989-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k891477-clirans-hollow-fiber-hemodialyzer-wet-fda-510k.jpg K891477 - CLIRANS HOLLOW FIBER HEMODIALYZER (WET) K891477 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Terumo Medical Corp.. Cleared Jun 1989. https://www.510kdatabase.net/k891574/ 1989-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k891574-lithium-concentrate-sr1031-nak-fda-510k.jpg K891574 - LITHIUM CONCENTRATE #SR1031, NA/K STANDARDS SR1030 K891574 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jun 1989. https://www.510kdatabase.net/k891991/ 1989-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k891991-bicarbonate-fda-510k.jpg K891991 - BICARBONATE K891991 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jun 1989. https://www.510kdatabase.net/k892424/ 1989-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k892424-rep-spe-hi-res-system-no-3176-3177-3178-fda-510k.jpg K892424 - REP SPE HI-RES SYSTEM NO. 3176, 3177, 3178 K892424 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Jun 1989. https://www.510kdatabase.net/k893223/ 1989-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k893223-rep-lipo-8-kit-no-3182rep-lipo-16-kit-fda-510k.jpg K893223 - REP LIPO-8 KIT, NO. 3182/REP LIPO-16 KIT, NO. 3181 K893223 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Jun 1989. https://www.510kdatabase.net/k890489/ 1989-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k890489-extension-set-wflow-regulator-fda-510k.jpg K890489 - EXTENSION SET W/FLOW REGULATOR K890489 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jun 1989. https://www.510kdatabase.net/k893188/ 1989-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k893188-quinton-single-lumen-catheter-fda-510k.jpg K893188 - QUINTON SINGLE LUMEN CATHETER K893188 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quinton, Inc.. Cleared Jun 1989. https://www.510kdatabase.net/k891454/ 1989-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k891454-exeter-ii-total-hip-system-fda-510k.jpg K891454 - EXETER II TOTAL HIP SYSTEM K891454 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jun 1989. https://www.510kdatabase.net/k892050/ 1989-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k892050-helena-thromboplastin-reagent-fda-510k.jpg K892050 - HELENA THROMBOPLASTIN REAGENT K892050 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Jun 1989. https://www.510kdatabase.net/k892238/ 1989-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k892238-cla-200-chempror-lipid-analyzer-fda-510k.jpg K892238 - CLA 200 CHEMPRO(R) LIPID ANALYZER K892238 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jun 1989. https://www.510kdatabase.net/k892863/ 1989-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k892863-easy-test-iron-iron-item-no-16686-fda-510k.jpg K892863 - EASY-TEST IRON (IRON) ITEM NO. 16686 K892863 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jun 1989. https://www.510kdatabase.net/k893237/ 1989-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k893237-argenco-w-fda-510k.jpg K893237 - ARGENCO W K893237 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jun 1989. https://www.510kdatabase.net/k891262/ 1989-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k891262-kdg-acetabular-component-fda-510k.jpg K891262 - KDG ACETABULAR COMPONENT K891262 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Jun 1989. https://www.510kdatabase.net/k893010/ 1989-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k893010-argelite-54-fda-510k.jpg K893010 - ARGELITE 54+ K893010 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jun 1989. https://www.510kdatabase.net/k893228/ 1989-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k893228-argenco-w-lite-fda-510k.jpg K893228 - ARGENCO W-LITE K893228 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jun 1989. https://www.510kdatabase.net/k893238/ 1989-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k893238-argenco-wlf-fda-510k.jpg K893238 - ARGENCO WLF K893238 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jun 1989. https://www.510kdatabase.net/k893244/ 1989-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k893244-argenco-wr-fda-510k.jpg K893244 - ARGENCO WR+ K893244 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jun 1989. https://www.510kdatabase.net/k890936/ 1989-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k890936-alta-hollow-tibial-rods-fda-510k.jpg K890936 - ALTA HOLLOW TIBIAL RODS K890936 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jun 1989. https://www.510kdatabase.net/k891908/ 1989-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k891908-bardr-tip-deflecting-electrode-catheter-fda-510k.jpg K891908 - BARD(R) TIP DEFLECTING ELECTRODE CATHETER K891908 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jun 1989. https://www.510kdatabase.net/k884720/ 1989-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k884720-germ-tube-solution-fda-510k.jpg K884720 - GERM TUBE SOLUTION K884720 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Jun 1989. https://www.510kdatabase.net/k891577/ 1989-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k891577-sceptor-data-management-center-software-fda-510k.jpg K891577 - SCEPTOR DATA MANAGEMENT CENTER SOFTWARE K891577 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jun 1989. https://www.510kdatabase.net/k892197/ 1989-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k892197-alatop-tm-catalog-akal1-fda-510k.jpg K892197 - ALATOP (TM) CATALOG # AKAL1 K892197 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jun 1989. https://www.510kdatabase.net/k892371/ 1989-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k892371-chlamydiazyme-blocking-reagent-fda-510k.jpg K892371 - CHLAMYDIAZYME BLOCKING REAGENT K892371 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1989. https://www.510kdatabase.net/k892709/ 1989-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k892709-argedent-62-dental-alloy-fda-510k.jpg K892709 - ARGEDENT 62 DENTAL ALLOY K892709 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jun 1989. https://www.510kdatabase.net/k892810/ 1989-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k892810-argedent-35sf-fda-510k.jpg K892810 - ARGEDENT 35SF K892810 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared Jun 1989. https://www.510kdatabase.net/k890644/ 1989-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k890644-medtronic-model-5866-45-sizing-sleeve-fda-510k.jpg K890644 - MEDTRONIC MODEL 5866-45 SIZING SLEEVE K890644 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared May 1989. https://www.510kdatabase.net/k892335/ 1989-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k892335-argedent-74-dental-alloy-for-porcelain-fda-510k.jpg K892335 - ARGEDENT 74 DENTAL ALLOY FOR PORCELAIN APPLI. K892335 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared May 1989. https://www.510kdatabase.net/k891989/ 1989-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k891989-argedent-52-dental-alloy-fda-510k.jpg K891989 - ARGEDENT 52 (DENTAL ALLOY) K891989 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared May 1989. https://www.510kdatabase.net/k891407/ 1989-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k891407-leucoprep-cell-separation-tube-fda-510k.jpg K891407 - LEUCOPREP CELL SEPARATION TUBE K891407 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared May 1989. https://www.510kdatabase.net/k892927/ 1989-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k892927-proximate-linear-cutter-thick-tissue-fda-510k.jpg K892927 - PROXIMATE LINEAR CUTTER THICK TISSUE INST. K892927 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared May 1989. https://www.510kdatabase.net/k892648/ 1989-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k892648-microvasive-endotorque-guidewire-cat-fda-510k.jpg K892648 - MICROVASIVE ENDOTORQUE GUIDEWIRE, CAT #5177 K892648 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared May 1989. https://www.510kdatabase.net/k892662/ 1989-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k892662-argedent-87-fda-510k.jpg K892662 - ARGEDENT 87 K892662 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared May 1989. https://www.510kdatabase.net/k893012/ 1989-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k893012-argelite-60-fda-510k.jpg K893012 - ARGELITE 60+ K893012 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared May 1989. https://www.510kdatabase.net/k890939/ 1989-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k890939-dupont-distal-humeral-nail-fda-510k.jpg K890939 - DUPONT DISTAL HUMERAL NAIL K890939 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared May 1989. https://www.510kdatabase.net/k891462/ 1989-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k891462-rocher-cardioscreen-ck-fda-510k.jpg K891462 - ROCHE(R) CARDIOSCREEN-CK K891462 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared May 1989. https://www.510kdatabase.net/k891968/ 1989-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k891968-esp-radiation-reduction-examination-fda-510k.jpg K891968 - ESP RADIATION REDUCTION EXAMINATION GLOVES K891968 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Boston Scientific Corp. Cleared May 1989. https://www.510kdatabase.net/k892814/ 1989-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k892814-argedent-45-fda-510k.jpg K892814 - ARGEDENT 45 K892814 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared May 1989. https://www.510kdatabase.net/k892900/ 1989-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k892900-aca-vancomycin-vanc-method-fda-510k.jpg K892900 - ACA VANCOMYCIN (VANC) METHOD K892900 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared May 1989. https://www.510kdatabase.net/k892909/ 1989-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k892909-argelite-80sf-dental-alloy-fda-510k.jpg K892909 - ARGELITE 80SF+ DENTAL ALLOY K892909 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared May 1989. https://www.510kdatabase.net/k892943/ 1989-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k892943-multi-pulse-power-unit-generator-fda-510k.jpg K892943 - MULTI PULSE POWER UNIT GENERATOR K892943 is a FDA 510(k) cleared radiology medical device. Manufacturer: GE Medical Systems. Cleared May 1989. https://www.510kdatabase.net/k891320/ 1989-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k891320-argelite-58p-dental-alloy-fda-510k.jpg K891320 - ARGELITE 58P (DENTAL ALLOY) K891320 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared May 1989. https://www.510kdatabase.net/k892708/ 1989-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k892708-argedent-y-86-dental-alloy-fda-510k.jpg K892708 - ARGEDENT Y-86 DENTAL ALLOY K892708 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared May 1989. https://www.510kdatabase.net/k892812/ 1989-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k892812-argelite-756-fda-510k.jpg K892812 - ARGELITE 75+6 K892812 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared May 1989. https://www.510kdatabase.net/k892813/ 1989-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k892813-argelite-60-fda-510k.jpg K892813 - ARGELITE 60 K892813 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared May 1989. https://www.510kdatabase.net/k892815/ 1989-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k892815-argedent-45sf-fda-510k.jpg K892815 - ARGEDENT 45SF K892815 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared May 1989. https://www.510kdatabase.net/k892816/ 1989-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k892816-argedent-38-fda-510k.jpg K892816 - ARGEDENT 38 K892816 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared May 1989. https://www.510kdatabase.net/k892908/ 1989-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k892908-argelite-80sf-dental-alloy-fda-510k.jpg K892908 - ARGELITE 80SF DENTAL ALLOY K892908 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared May 1989. https://www.510kdatabase.net/k893008/ 1989-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k893008-argelite-54-fda-510k.jpg K893008 - ARGELITE 54 K893008 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared May 1989. https://www.510kdatabase.net/k893009/ 1989-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k893009-argelite-sr-fda-510k.jpg K893009 - ARGELITE SR+ K893009 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared May 1989. https://www.510kdatabase.net/k893011/ 1989-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k893011-argipal-fda-510k.jpg K893011 - ARGIPAL K893011 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared May 1989. https://www.510kdatabase.net/k890274/ 1989-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k890274-mem-7102-fda-510k.jpg K890274 - MEM-7102 K890274 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared May 1989. https://www.510kdatabase.net/k891455/ 1989-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k891455-dentin-primer-fda-510k.jpg K891455 - DENTIN PRIMER K891455 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared May 1989. https://www.510kdatabase.net/k892113/ 1989-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k892113-q5000-pc-workstation-fda-510k.jpg K892113 - Q5000 PC WORKSTATION K892113 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared May 1989. https://www.510kdatabase.net/k892234/ 1989-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k892234-argedent-75-fda-510k.jpg K892234 - ARGEDENT 75 K892234 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared May 1989. https://www.510kdatabase.net/k892897/ 1989-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k892897-nova-geltm-jo-1-fda-510k.jpg K892897 - NOVA GEL(TM) JO-1 K892897 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared May 1989. https://www.510kdatabase.net/k891009/ 1989-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k891009-intravascular-administration-set-model-fda-510k.jpg K891009 - INTRAVASCULAR ADMINISTRATION SET MODEL 60040 K891009 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared May 1989. https://www.510kdatabase.net/k891482/ 1989-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k891482-amlr-collarless-lateralized-femoral-hip-fda-510k.jpg K891482 - AML(R) COLLARLESS LATERALIZED FEMORAL HIP K891482 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared May 1989. https://www.510kdatabase.net/k892650/ 1989-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k892650-tdx-barbiturates-serum-fda-510k.jpg K892650 - TDX BARBITURATES SERUM K892650 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared May 1989. https://www.510kdatabase.net/k892901/ 1989-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k892901-aca-vancomycin-calibrator-fda-510k.jpg K892901 - ACA VANCOMYCIN CALIBRATOR K892901 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared May 1989. https://www.510kdatabase.net/k891005/ 1989-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k891005-intravascular-admini-set-models-60030-fda-510k.jpg K891005 - INTRAVASCULAR ADMINI. SET MODELS 60030 & 60050 K891005 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared May 1989. https://www.510kdatabase.net/k891911/ 1989-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k891911-argedent-52sf-fda-510k.jpg K891911 - ARGEDENT 52SF K891911 is a FDA 510(k) cleared dental medical device. Manufacturer: Argen Precious Metals, Inc.. Cleared May 1989. https://www.510kdatabase.net/k892235/ 1989-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k892235-ge-shoulder-surface-coil-cat-m1085an-fda-510k.jpg K892235 - GE SHOULDER SURFACE COIL, CAT. #M1085AN K892235 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared May 1989. https://www.510kdatabase.net/k890772/ 1989-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k890772-ultrasonic-imaging-catheter-for-fda-510k.jpg K890772 - ULTRASONIC IMAGING CATHETER FOR CARDIAC APPLI. K890772 is a FDA 510(k) cleared radiology medical device. Manufacturer: Boston Scientific Corp. Cleared May 1989. https://www.510kdatabase.net/k891929/ 1989-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k891929-moni-trolr-fda-510k.jpg K891929 - MONI-TROL(R) K891929 is a FDA 510(k) cleared immunology medical device. Manufacturer: Baxter Healthcare Corp. Cleared May 1989. https://www.510kdatabase.net/k892198/ 1989-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k892198-technicon-dpa-1-tm-crp-method-fda-510k.jpg K892198 - TECHNICON DPA-1 (TM) CRP METHOD K892198 is a FDA 510(k) cleared immunology medical device. Manufacturer: Technicon Instruments Corp.. Cleared May 1989. https://www.510kdatabase.net/k885271/ 1989-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k885271-bdac-omicron-plus-surgical-gloves-fda-510k.jpg K885271 - BDAC OMICRON PLUS SURGICAL GLOVES K885271 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared May 1989. https://www.510kdatabase.net/k884107/ 1989-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k884107-stereotactic-biopsy-attachment-fda-510k.jpg K884107 - STEREOTACTIC BIOPSY ATTACHMENT K884107 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 1989. https://www.510kdatabase.net/k884564/ 1989-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k884564-shiley-therapeutic-autotransfusion-fda-510k.jpg K884564 - SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM-PROGRAMM K884564 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shiley, Inc.. Cleared May 1989. https://www.510kdatabase.net/k885031/ 1989-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k885031-low-adsorption-administration-set-fda-510k.jpg K885031 - LOW ADSORPTION ADMINISTRATION SET K885031 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared May 1989. https://www.510kdatabase.net/k891375/ 1989-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k891375-iq-albumin-fda-510k.jpg K891375 - IQ ALBUMIN K891375 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared May 1989. https://www.510kdatabase.net/k883641/ 1989-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k883641-selective-rapid-urea-fda-510k.jpg K883641 - SELECTIVE RAPID UREA K883641 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared May 1989. https://www.510kdatabase.net/k890818/ 1989-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k890818-auto-suture-disposable-surgical-trocar-fda-510k.jpg K890818 - AUTO SUTURE DISPOSABLE SURGICAL TROCAR* K890818 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared May 1989. https://www.510kdatabase.net/k892223/ 1989-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k892223-behring-nephelometer-100-fda-510k.jpg K892223 - BEHRING NEPHELOMETER 100 K892223 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared May 1989. https://www.510kdatabase.net/k890784/ 1989-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k890784-mammomat-c-fda-510k.jpg K890784 - MAMMOMAT C K890784 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 1989. https://www.510kdatabase.net/k891167/ 1989-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k891167-coat-a-counttm-lsd-radioimmunoassay-kit-fda-510k.jpg K891167 - COAT-A-COUNT(TM) LSD RADIOIMMUNOASSAY KIT K891167 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared May 1989. https://www.510kdatabase.net/k891217/ 1989-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k891217-iq-calcium-fda-510k.jpg K891217 - IQ CALCIUM K891217 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared May 1989. https://www.510kdatabase.net/k890808/ 1989-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k890808-sarns-membrane-oxygenator-wintegral-fda-510k.jpg K890808 - SARNS MEMBRANE OXYGENATOR W/INTEGRAL CARDIO RESERV K890808 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: 3M Company. Cleared May 1989. https://www.510kdatabase.net/k890980/ 1989-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k890980-modified-stockert-shiley-venous-catheter-fda-510k.jpg K890980 - MODIFIED STOCKERT-SHILEY VENOUS CATHETER K890980 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared May 1989. https://www.510kdatabase.net/k891269/ 1989-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k891269-microtrak-eia-autowasher-fda-510k.jpg K891269 - MICROTRAK EIA AUTOWASHER K891269 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Syva Co.. Cleared May 1989. https://www.510kdatabase.net/k892233/ 1989-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k892233-auto-suturer-endoscopic-giatm-surgical-fda-510k.jpg K892233 - AUTO SUTURE(R) ENDOSCOPIC GIA(TM) SURGICAL STAPLER K892233 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Apr 1989. https://www.510kdatabase.net/k890354/ 1989-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k890354-tegapore-wound-contact-material-fda-510k.jpg K890354 - TEGAPORE WOUND CONTACT MATERIAL, PRODUCT #563X K890354 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3M Company. Cleared Apr 1989. https://www.510kdatabase.net/k890870/ 1989-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k890870-bard-gastrostomy-feeding-device-fda-510k.jpg K890870 - BARD GASTROSTOMY FEEDING DEVICE K890870 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 1989. https://www.510kdatabase.net/k890871/ 1989-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k890871-bard-mossr-gastrostomy-tube-fda-510k.jpg K890871 - BARD MOSS(R) GASTROSTOMY TUBE K890871 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 1989. https://www.510kdatabase.net/k884621/ 1989-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k884621-digiscan-fda-510k.jpg K884621 - DIGISCAN K884621 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 1989. https://www.510kdatabase.net/k891093/ 1989-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k891093-aca-r-digitoxin-calibrator-fda-510k.jpg K891093 - ACA (R) DIGITOXIN CALIBRATOR K891093 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Apr 1989. https://www.510kdatabase.net/k891094/ 1989-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k891094-acar-digitoxin-dgtx-method-fda-510k.jpg K891094 - ACA(R) DIGITOXIN (DGTX) METHOD K891094 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Apr 1989. https://www.510kdatabase.net/k891261/ 1989-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k891261-intraoperative-radiation-therapy-devices-fda-510k.jpg K891261 - INTRAOPERATIVE RADIATION THERAPY DEVICES K891261 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Apr 1989. https://www.510kdatabase.net/k884322/ 1989-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k884322-subclavian-hemodialysis-catheter-fda-510k.jpg K884322 - SUBCLAVIAN HEMODIALYSIS CATHETER K884322 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1989. https://www.510kdatabase.net/k884325/ 1989-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k884325-subclavian-hemodialysis-cath-wvitacuff-fda-510k.jpg K884325 - SUBCLAVIAN HEMODIALYSIS CATH. W/VITACUFF DEVICE K884325 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1989. https://www.510kdatabase.net/k890869/ 1989-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k890869-bard-hysterosalpingography-catheters-fda-510k.jpg K890869 - BARD HYSTEROSALPINGOGRAPHY CATHETERS K890869 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 1989. https://www.510kdatabase.net/k890420/ 1989-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k890420-usci-7f-guide-catheter-fda-510k.jpg K890420 - USCI 7F GUIDE CATHETER K890420 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 1989. https://www.510kdatabase.net/k882610/ 1989-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k882610-cook-gianturco-biliary-z-stent-fda-510k.jpg K882610 - COOK-GIANTURCO BILIARY Z STENT K882610 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook, Inc.. Cleared Apr 1989. https://www.510kdatabase.net/k884797/ 1989-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k884797-berichrom-alpha-2-antiplasmin-fda-510k.jpg K884797 - BERICHROM ALPHA-2-ANTIPLASMIN K884797 is a FDA 510(k) cleared hematology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Apr 1989. https://www.510kdatabase.net/k890527/ 1989-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k890527-alternate-packaging-configuration-for-fda-510k.jpg K890527 - ALTERNATE PACKAGING CONFIGURATION FOR PACING LEADS K890527 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Apr 1989. https://www.510kdatabase.net/k890633/ 1989-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k890633-enzygnost-platelet-factor-4-pf4-kit-fda-510k.jpg K890633 - ENZYGNOST PLATELET FACTOR 4 (PF4) KIT K890633 is a FDA 510(k) cleared hematology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Apr 1989. https://www.510kdatabase.net/k890634/ 1989-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k890634-berichrom-protein-c-kit-fda-510k.jpg K890634 - BERICHROM PROTEIN C KIT K890634 is a FDA 510(k) cleared hematology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Apr 1989. https://www.510kdatabase.net/k892004/ 1989-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k892004-liquichekr-serum-alcohol-control-fda-510k.jpg K892004 - LIQUICHEK(R) SERUM ALCOHOL CONTROL K892004 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Apr 1989. https://www.510kdatabase.net/k890795/ 1989-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k890795-respironics-sealeasy-ii-fda-510k.jpg K890795 - RESPIRONICS SEALEASY II K890795 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Apr 1989. https://www.510kdatabase.net/k890282/ 1989-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k890282-resubmitted-abbott-lifecare-model-3-hb-fda-510k.jpg K890282 - RESUBMITTED ABBOTT LIFECARE MODEL 3 HB PUMP K890282 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1989. https://www.510kdatabase.net/k890841/ 1989-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k890841-titanium-staples-fda-510k.jpg K890841 - TITANIUM STAPLES K890841 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Apr 1989. https://www.510kdatabase.net/k884913/ 1989-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k884913-merit-intelliflatortm-merit-monitortm-fda-510k.jpg K884913 - MERIT INTELLIFLATOR(TM) & MERIT MONITOR(TM) K884913 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Apr 1989. https://www.510kdatabase.net/k884166/ 1989-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k884166-dicor-ceramic-inlay-new-technic-fda-510k.jpg K884166 - DICOR CERAMIC INLAY - NEW TECHNIC K884166 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Apr 1989. https://www.510kdatabase.net/k890831/ 1989-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k890831-emit-convenience-pack-thyroxine-assay-fda-510k.jpg K890831 - EMIT CONVENIENCE PACK: THYROXINE ASSAY K890831 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Apr 1989. https://www.510kdatabase.net/k890904/ 1989-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k890904-modified-stockert-shiley-caps-multi-fda-510k.jpg K890904 - MODIFIED STOCKERT-SHILEY CAPS MULTI. ROLLER PUMP K890904 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Apr 1989. https://www.510kdatabase.net/k891683/ 1989-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k891683-titan-gel-ife-free-kappalamba-light-fda-510k.jpg K891683 - TITAN GEL IFE FREE KAPPA/LAMBA LIGHT CHAIN ANTISER K891683 is a FDA 510(k) cleared immunology medical device. Manufacturer: Helena Laboratories. Cleared Apr 1989. https://www.510kdatabase.net/k890698/ 1989-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k890698-abbott-alt-activated-liquid-list-01a55-fda-510k.jpg K890698 - ABBOTT ALT-ACTIVATED (LIQUID, LIST #01A55) K890698 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1989. https://www.510kdatabase.net/k891169/ 1989-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k891169-dade-thromboplastin-is-fda-510k.jpg K891169 - DADE THROMBOPLASTIN IS K891169 is a FDA 510(k) cleared hematology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Apr 1989. https://www.510kdatabase.net/k890197/ 1989-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k890197-omnifit-constrained-acetabular-bearing-fda-510k.jpg K890197 - OMNIFIT CONSTRAINED ACETABULAR BEARING INSERT K890197 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Apr 1989. https://www.510kdatabase.net/k890941/ 1989-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k890941-modified-suture-disp-endoscopic-fda-510k.jpg K890941 - MODIFIED SUTURE DISP. ENDOSCOPIC SURGICAL CLIP APP K890941 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Apr 1989. https://www.510kdatabase.net/k890873/ 1989-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k890873-glucofilm-test-strips-fda-510k.jpg K890873 - GLUCOFILM TEST STRIPS & CONTROLS/GLUCOMETER 3 K890873 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Apr 1989. https://www.510kdatabase.net/k890815/ 1989-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k890815-magnetic-resonance-diagnostic-device-fda-510k.jpg K890815 - MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES K890815 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 1989. https://www.510kdatabase.net/k881235/ 1989-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k881235-q-plex-1-fda-510k.jpg K881235 - Q-PLEX 1 K881235 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Quinton, Inc.. Cleared Mar 1989. https://www.510kdatabase.net/k885253/ 1989-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k885253-acculevel-one-step-theophylline-test-fda-510k.jpg K885253 - ACCULEVEL ONE-STEP THEOPHYLLINE TEST K885253 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Mar 1989. https://www.510kdatabase.net/k890528/ 1989-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k890528-roche-chloride-electrode-fda-510k.jpg K890528 - ROCHE CHLORIDE ELECTRODE K890528 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Mar 1989. https://www.510kdatabase.net/k890798/ 1989-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k890798-revised-magnesium-test-item-number-fda-510k.jpg K890798 - REVISED MAGNESIUM TEST ITEM NUMBER: SR1019 K890798 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Mar 1989. https://www.510kdatabase.net/k891697/ 1989-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k891697-abuscreen-fp-benzodiazephine-reagent-fda-510k.jpg K891697 - ABUSCREEN FP BENZODIAZEPHINE REAGENT K891697 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Mar 1989. https://www.510kdatabase.net/k884796/ 1989-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k884796-pfctm-modular-knee-system-fda-510k.jpg K884796 - P.F.C.(TM) MODULAR KNEE SYSTEM K884796 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Mar 1989. https://www.510kdatabase.net/k884184/ 1989-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k884184-sigma-procedure-no-465-for-deter-of-fda-510k.jpg K884184 - SIGMA PROCEDURE NO. 465 FOR DETER. OF FRUCTOSAMINE K884184 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Mar 1989. https://www.510kdatabase.net/k885203/ 1989-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k885203-technicon-daxtm-system-fda-510k.jpg K885203 - TECHNICON DAX(TM) SYSTEM K885203 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Mar 1989. https://www.510kdatabase.net/k885272/ 1989-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k885272-cholinesterase-reagent-dibucaine-fda-510k.jpg K885272 - CHOLINESTERASE REAGENT, DIBUCAINE & FLUORIDE K885272 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Mar 1989. https://www.510kdatabase.net/k890411/ 1989-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k890411-models-432-03-433-03-implantable-fda-510k.jpg K890411 - MODELS 432-03 & 433-03 IMPLANTABLE PACING LEADS K890411 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Mar 1989. https://www.510kdatabase.net/k890412/ 1989-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k890412-models-430-07-431-07-implantable-fda-510k.jpg K890412 - MODELS 430-07 & 431-07 IMPLANTABLE PACING LEADS K890412 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Mar 1989. https://www.510kdatabase.net/k890802/ 1989-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k890802-cotubetm-tsh-irma-fda-510k.jpg K890802 - COTUBE(TM) TSH IRMA K890802 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Mar 1989. https://www.510kdatabase.net/k890927/ 1989-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k890927-kodak-ektachem-500750-series-analyzer-fda-510k.jpg K890927 - KODAK EKTACHEM 500/750 SERIES ANALYZER, SOFT V1.0 K890927 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Mar 1989. https://www.510kdatabase.net/k890928/ 1989-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k890928-kodak-ektachem-500-analyzer-fda-510k.jpg K890928 - KODAK EKTACHEM 500 ANALYZER K890928 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Mar 1989. https://www.510kdatabase.net/k890929/ 1989-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k890929-kodak-ektachem-750-series-analyzer-fda-510k.jpg K890929 - KODAK EKTACHEM 750 SERIES ANALYZER K890929 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Mar 1989. https://www.510kdatabase.net/k890288/ 1989-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k890288-peritoneal-catheters-with-an-added-fda-510k.jpg K890288 - PERITONEAL CATHETERS WITH AN ADDED FUNCTION K890288 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quinton, Inc.. Cleared Mar 1989. https://www.510kdatabase.net/k890422/ 1989-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k890422-abbott-testpacktm-d-dimer-fda-510k.jpg K890422 - ABBOTT TESTPACK(TM) D-DIMER K890422 is a FDA 510(k) cleared hematology medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1989. https://www.510kdatabase.net/k890530/ 1989-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k890530-n-latex-ige-kit-immunoglobulin-e-fda-510k.jpg K890530 - N LATEX IGE KIT (IMMUNOGLOBULIN E REAGENTS) K890530 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Mar 1989. https://www.510kdatabase.net/k890510/ 1989-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k890510-abbott-ovulation-predictor-test-fda-510k.jpg K890510 - ABBOTT OVULATION PREDICTOR TEST K890510 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1989. https://www.510kdatabase.net/k890521/ 1989-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k890521-abbott-clinical-chemistry-reagent-alp-fda-510k.jpg K890521 - ABBOTT CLINICAL CHEMISTRY REAGENT ALP K890521 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1989. https://www.510kdatabase.net/k890908/ 1989-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k890908-stratusr-ii-fluorometric-analyzer-fda-510k.jpg K890908 - STRATUS(R) II FLUOROMETRIC ANALYZER & ACCESSORIES K890908 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 1989. https://www.510kdatabase.net/k885316/ 1989-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k885316-disposable-intrauterine-pressure-kit-fda-510k.jpg K885316 - DISPOSABLE INTRAUTERINE PRESSURE KIT MODEL 13972A K885316 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Mar 1989. https://www.510kdatabase.net/k885292/ 1989-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k885292-cobas-mfc-fda-510k.jpg K885292 - COBAS MFC K885292 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Mar 1989. https://www.510kdatabase.net/k890196/ 1989-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k890196-microtrak-chlamydia-eia-fda-510k.jpg K890196 - MICROTRAK CHLAMYDIA EIA K890196 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Syva Co.. Cleared Mar 1989. https://www.510kdatabase.net/k891075/ 1989-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k891075-bard-neonatal-ecg-monitoring-electrode-fda-510k.jpg K891075 - BARD NEONATAL ECG MONITORING ELECTRODE K891075 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 1989. https://www.510kdatabase.net/k891188/ 1989-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k891188-titan-gel-ife-trivalent-antiserum-fda-510k.jpg K891188 - TITAN GEL IFE TRIVALENT ANTISERUM K891188 is a FDA 510(k) cleared immunology medical device. Manufacturer: Helena Laboratories. Cleared Mar 1989. https://www.510kdatabase.net/k891218/ 1989-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k891218-iqqca-phosphorus-fda-510k.jpg K891218 - IQ/QCA PHOSPHORUS K891218 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1989. https://www.510kdatabase.net/k891299/ 1989-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k891299-mid-level-igg-kit-cat-no-9315-fda-510k.jpg K891299 - MID-LEVEL IGG KIT CAT. NO. 9315 K891299 is a FDA 510(k) cleared immunology medical device. Manufacturer: Helena Laboratories. Cleared Mar 1989. https://www.510kdatabase.net/k883842/ 1989-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k883842-dental-alginate-impression-material-fda-510k.jpg K883842 - DENTAL ALGINATE IMPRESSION MATERIAL W/ANTI. ADDI. K883842 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Mar 1989. https://www.510kdatabase.net/k885208/ 1989-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k885208-receptal-saf-gardtm-system-fda-510k.jpg K885208 - RECEPTAL SAF-GARD(TM) SYSTEM K885208 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1989. https://www.510kdatabase.net/k890270/ 1989-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k890270-auto-suture-absorbable-fascia-surgical-fda-510k.jpg K890270 - AUTO SUTURE ABSORBABLE FASCIA SURGICAL STAPLER* K890270 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Mar 1989. https://www.510kdatabase.net/k890887/ 1989-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k890887-abuscreen-fp-for-cannabinoids-fda-510k.jpg K890887 - ABUSCREEN FP FOR CANNABINOIDS K890887 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Mar 1989. https://www.510kdatabase.net/k884686/ 1989-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k884686-vapamasta-5-fda-510k.jpg K884686 - VAPAMASTA 5 K884686 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Dentsply Intl.. Cleared Mar 1989. https://www.510kdatabase.net/k885338/ 1989-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k885338-aml-bowed-femoral-hip-fda-510k.jpg K885338 - AML BOWED FEMORAL HIP K885338 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Mar 1989. https://www.510kdatabase.net/k890060/ 1989-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k890060-ceramic-total-hip-ball-head-large-taper-fda-510k.jpg K890060 - CERAMIC TOTAL HIP BALL HEAD, LARGE TAPER K890060 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Mar 1989. https://www.510kdatabase.net/k890201/ 1989-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k890201-radiolucent-ecg-electrode-model-no-1680-fda-510k.jpg K890201 - RADIOLUCENT ECG ELECTRODE MODEL NO: 1680 K890201 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Mar 1989. https://www.510kdatabase.net/k890325/ 1989-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k890325-usci-disp-y-connector-wmodified-tuohy-fda-510k.jpg K890325 - USCI DISP. Y-CONNECTOR W/MODIFIED TUOHY-BORST ADAP K890325 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 1989. https://www.510kdatabase.net/k890470/ 1989-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k890470-riatrac-plus-fda-510k.jpg K890470 - RIATRAC PLUS K890470 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1989. https://www.510kdatabase.net/k890882/ 1989-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k890882-abuscreen-fp-for-phencyclidine-fda-510k.jpg K890882 - ABUSCREEN FP FOR PHENCYCLIDINE K890882 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Mar 1989. https://www.510kdatabase.net/k890883/ 1989-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k890883-abuscreen-fp-buffer-reagent-fda-510k.jpg K890883 - ABUSCREEN FP BUFFER REAGENT K890883 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Mar 1989. https://www.510kdatabase.net/k890888/ 1989-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k890888-abuscreen-fp-for-morphine-fda-510k.jpg K890888 - ABUSCREEN FP FOR MORPHINE K890888 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Mar 1989. https://www.510kdatabase.net/k885047/ 1989-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k885047-vista-mr-2055-hp-system-fda-510k.jpg K885047 - VISTA MR 2055 HP SYSTEM K885047 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Mar 1989. https://www.510kdatabase.net/k885207/ 1989-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k885207-kodak-multiloader-700-fda-510k.jpg K885207 - KODAK MULTILOADER 700 K885207 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Mar 1989. https://www.510kdatabase.net/k885228/ 1989-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k885228-rt6800-echocardiography-system-fda-510k.jpg K885228 - RT6800 ECHOCARDIOGRAPHY SYSTEM K885228 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Mar 1989. https://www.510kdatabase.net/k890771/ 1989-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k890771-aseptex-1812-sub-micron-molded-fda-510k.jpg K890771 - ASEPTEX 1812 SUB-MICRON MOLDED SURGICAL MASK K890771 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Mar 1989. https://www.510kdatabase.net/k884301/ 1989-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k884301-edwards-disposable-arthroscopy-cannula-fda-510k.jpg K884301 - EDWARDS DISPOSABLE ARTHROSCOPY CANNULA K884301 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 1989. https://www.510kdatabase.net/k890649/ 1989-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k890649-omnifit-uhmwpe-acetabular-shell-cement-fda-510k.jpg K890649 - OMNIFIT UHMWPE ACETABULAR SHELL CEMENT SPACE SYST. K890649 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Mar 1989. https://www.510kdatabase.net/k890885/ 1989-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k890885-abuscreen-fp-for-cocaine-metabolite-fda-510k.jpg K890885 - ABUSCREEN FP FOR COCAINE METABOLITE K890885 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Mar 1989. https://www.510kdatabase.net/k884757/ 1989-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k884757-clinistat-cholesterol-reagent-test-fda-510k.jpg K884757 - CLINISTAT CHOLESTEROL REAGENT TEST K884757 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Mar 1989. https://www.510kdatabase.net/k885247/ 1989-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k885247-standard-tuohy-borst-dual-valve-y-fda-510k.jpg K885247 - STANDARD, TUOHY BORST & DUAL VALVE Y-CONNECTOR K885247 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 1989. https://www.510kdatabase.net/k890886/ 1989-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k890886-abuscreen-fp-for-amphetamine-fda-510k.jpg K890886 - ABUSCREEN FP FOR AMPHETAMINE K890886 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Mar 1989. https://www.510kdatabase.net/k890278/ 1989-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k890278-total-protein-reagent-fda-510k.jpg K890278 - TOTAL PROTEIN REAGENT K890278 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Mar 1989. https://www.510kdatabase.net/k890421/ 1989-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k890421-imx-b2-microglobulin-fda-510k.jpg K890421 - IMX B2-MICROGLOBULIN K890421 is a FDA 510(k) cleared immunology medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1989. https://www.510kdatabase.net/k890884/ 1989-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k890884-abuscreen-fp-for-barbiturates-fda-510k.jpg K890884 - ABUSCREEN FP FOR BARBITURATES K890884 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Mar 1989. https://www.510kdatabase.net/k884528/ 1989-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k884528-seralyzer-digoxin-assaytest-fda-510k.jpg K884528 - SERALYZER DIGOXIN ASSAY/TEST MOD/CALIB/CONTR/AMES K884528 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Mar 1989. https://www.510kdatabase.net/k885334/ 1989-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k885334-vac-rite-fda-510k.jpg K885334 - VAC-RITE K885334 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1989. https://www.510kdatabase.net/k890269/ 1989-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k890269-alkaline-phosphatase-isoenzyme-reagents-fda-510k.jpg K890269 - ALKALINE PHOSPHATASE ISOENZYME REAGENTS K890269 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Mar 1989. https://www.510kdatabase.net/k884106/ 1989-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k884106-supervisory-telemetry-arrhythmia-fda-510k.jpg K884106 - SUPERVISORY TELEMETRY ARRHYTHMIA TERMINAL K884106 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 1989. https://www.510kdatabase.net/k885045/ 1989-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k885045-pharmaclens-low-abrasion-wound-fda-510k.jpg K885045 - PHARMACLENS LOW ABRASION WOUND SPONGE/BRUSH K885045 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 1989. https://www.510kdatabase.net/k885281/ 1989-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k885281-vamp-venousarterial-blood-management-fda-510k.jpg K885281 - VAMP VENOUS/ARTERIAL BLOOD MANAGEMENT PROTECTION K885281 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 1989. https://www.510kdatabase.net/k890024/ 1989-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k890024-sarns-vent-catheter-fda-510k.jpg K890024 - SARNS VENT CATHETER K890024 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: 3M Company. Cleared Mar 1989. https://www.510kdatabase.net/k890750/ 1989-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k890750-kodak-x-omatic-ra-cassette-fda-510k.jpg K890750 - KODAK X-OMATIC RA CASSETTE K890750 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Mar 1989. https://www.510kdatabase.net/k883796/ 1989-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k883796-lifecare-micro-pump-fda-510k.jpg K883796 - LIFECARE MICRO PUMP K883796 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Feb 1989. https://www.510kdatabase.net/k884141/ 1989-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k884141-monoplace-hyperbaric-extension-set-l-fda-510k.jpg K884141 - MONOPLACE HYPERBARIC EXTENSION SET (L 11055) K884141 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Feb 1989. https://www.510kdatabase.net/k890685/ 1989-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k890685-bard-umbilical-vessel-catheter-fda-510k.jpg K890685 - BARD UMBILICAL VESSEL CATHETER K890685 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Feb 1989. https://www.510kdatabase.net/k885169/ 1989-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k885169-stamey-sampler-spring-loaded-biopsy-fda-510k.jpg K885169 - STAMEY SAMPLER SPRING LOADED BIOPSY NEEDLE K885169 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Feb 1989. https://www.510kdatabase.net/k890348/ 1989-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k890348-lc-cardiac-positioner-b5078a-fda-510k.jpg K890348 - LC, CARDIAC POSITIONER #B5078A K890348 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Feb 1989. https://www.510kdatabase.net/k890409/ 1989-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k890409-dader-plasminogen-chromogenic-assay-fda-510k.jpg K890409 - DADE(R) PLASMINOGEN CHROMOGENIC ASSAY K890409 is a FDA 510(k) cleared hematology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Feb 1989. https://www.510kdatabase.net/k890540/ 1989-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k890540-abbott-clinical-chemistry-reagent-ck-nac-fda-510k.jpg K890540 - ABBOTT CLINICAL CHEMISTRY REAGENT CK-NAC K890540 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Feb 1989. https://www.510kdatabase.net/k884688/ 1989-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k884688-modular-spinal-fixation-locking-hook-fda-510k.jpg K884688 - MODULAR SPINAL FIXATION & LOCKING HOOK SPINAL ROD K884688 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Feb 1989. https://www.510kdatabase.net/k885227/ 1989-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k885227-clinistat-hemoglobin-reagent-test-fda-510k.jpg K885227 - CLINISTAT HEMOGLOBIN REAGENT TEST K885227 is a FDA 510(k) cleared hematology medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Feb 1989. https://www.510kdatabase.net/k890361/ 1989-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k890361-kodak-min-r-2-cassette-fda-510k.jpg K890361 - KODAK MIN-R 2 CASSETTE K890361 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Feb 1989. https://www.510kdatabase.net/k890673/ 1989-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k890673-wright-glemsa-stain-fda-510k.jpg K890673 - WRIGHT-GLEMSA STAIN K890673 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Feb 1989. https://www.510kdatabase.net/k890674/ 1989-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k890674-accustaintm-automated-wright-giemsa-fda-510k.jpg K890674 - ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SET K890674 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Feb 1989. https://www.510kdatabase.net/k874778/ 1989-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k874778-kodak-ektascan-image-transmission-syst-fda-510k.jpg K874778 - KODAK EKTASCAN IMAGE TRANSMISSION SYST T1/R1 SFTWR K874778 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Feb 1989. https://www.510kdatabase.net/k884050/ 1989-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k884050-cns-8200a-central-nurses-station-fda-510k.jpg K884050 - CNS-8200A CENTRAL NURSES STATION K884050 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Feb 1989. https://www.510kdatabase.net/k884550/ 1989-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k884550-creatine-kinase-mb-enzyme-immunoassay-fda-510k.jpg K884550 - CREATINE KINASE MB ENZYME IMMUNOASSAY KIT K884550 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Feb 1989. https://www.510kdatabase.net/k885000/ 1989-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k885000-q750-electrocardiograph-fda-510k.jpg K885000 - Q750 ELECTROCARDIOGRAPH K885000 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Feb 1989. https://www.510kdatabase.net/k885061/ 1989-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k885061-siemens-intravaginal-transducer-fda-510k.jpg K885061 - SIEMENS INTRAVAGINAL TRANSDUCER K885061 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 1989. https://www.510kdatabase.net/k885341/ 1989-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k885341-titan-gel-alkaline-phosphatase-hr-fda-510k.jpg K885341 - TITAN GEL ALKALINE PHOSPHATASE (HR) K885341 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Feb 1989. https://www.510kdatabase.net/k890352/ 1989-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k890352-multiskop-fda-510k.jpg K890352 - MULTISKOP K890352 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 1989. https://www.510kdatabase.net/k884837/ 1989-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k884837-kinemax-tibial-wedge-fda-510k.jpg K884837 - KINEMAX TIBIAL WEDGE K884837 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Feb 1989. https://www.510kdatabase.net/k885023/ 1989-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k885023-cholesterol-test-item-number-sr1011-fda-510k.jpg K885023 - CHOLESTEROL TEST ITEM NUMBER: SR1011 K885023 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Feb 1989. https://www.510kdatabase.net/k885141/ 1989-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k885141-emit-thyroxine-assay-fda-510k.jpg K885141 - EMIT THYROXINE ASSAY K885141 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Feb 1989. https://www.510kdatabase.net/k885226/ 1989-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k885226-technicon-axontm-system-fda-510k.jpg K885226 - TECHNICON AXON(TM) SYSTEM K885226 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Feb 1989. https://www.510kdatabase.net/k890023/ 1989-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k890023-hdl-cholesterol-reagent-ptamgcl2-fda-510k.jpg K890023 - HDL CHOLESTEROL REAGENT (PTA/MGCL2) K890023 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Feb 1989. https://www.510kdatabase.net/k890305/ 1989-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k890305-bicarbonate-test-item-number-sr1006-fda-510k.jpg K890305 - BICARBONATE TEST ITEM NUMBER: SR1006 K890305 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Feb 1989. https://www.510kdatabase.net/k884680/ 1989-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k884680-kodak-surecell-herpes-hsv-test-kit-fda-510k.jpg K884680 - KODAK SURECELL HERPES (HSV) TEST KIT K884680 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Eastman Kodak Company. Cleared Feb 1989. https://www.510kdatabase.net/k884912/ 1989-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k884912-angiostar-fda-510k.jpg K884912 - ANGIOSTAR K884912 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 1989. https://www.510kdatabase.net/k890097/ 1989-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k890097-kodak-ektascan-laser-printer-digital-fda-510k.jpg K890097 - KODAK EKTASCAN LASER PRINTER DIGITAL, MODEL 1000 K890097 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Feb 1989. https://www.510kdatabase.net/k890467/ 1989-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k890467-kodak-portable-identification-camera-fda-510k.jpg K890467 - KODAK PORTABLE IDENTIFICATION CAMERA K890467 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Feb 1989. https://www.510kdatabase.net/k890542/ 1989-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k890542-multiwell-culture-plate-inserts-fda-510k.jpg K890542 - MULTIWELL CULTURE PLATE INSERTS K890542 is a FDA 510(k) cleared pathology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Feb 1989. https://www.510kdatabase.net/k883189/ 1989-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k883189-model-27080-calcutript-fda-510k.jpg K883189 - MODEL 27080 CALCUTRIPT ELECTROHYDRAULIC LITHR SYS K883189 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Feb 1989. https://www.510kdatabase.net/k885250/ 1989-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k885250-alta-tibialupper-extremity-metaphyseal-fda-510k.jpg K885250 - ALTA TIBIAL/UPPER EXTREMITY METAPHYSEAL PLATE SYS K885250 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Feb 1989. https://www.510kdatabase.net/k884547/ 1989-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k884547-creatine-kinase-mb-test-ck-mk-item-fda-510k.jpg K884547 - CREATINE KINASE-MB TEST (CK-MK) ITEM NUMBER 65673 K884547 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Feb 1989. https://www.510kdatabase.net/k884771/ 1989-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k884771-il-phoenix-model-900-chemistryelectrolyt-fda-510k.jpg K884771 - IL PHOENIX, MODEL 900, CHEMISTRY/ELECTROLYTE ANALY K884771 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Feb 1989. https://www.510kdatabase.net/k885134/ 1989-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k885134-clinistat-triglycerides-reagent-test-fda-510k.jpg K885134 - CLINISTAT TRIGLYCERIDES REAGENT TEST K885134 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Feb 1989. https://www.510kdatabase.net/k885143/ 1989-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k885143-absorbent-gauze-roll-fda-510k.jpg K885143 - ABSORBENT GAUZE ROLL K885143 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Feb 1989. https://www.510kdatabase.net/k885265/ 1989-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k885265-hdl-cholesterol-test-fda-510k.jpg K885265 - HDL CHOLESTEROL TEST K885265 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Feb 1989. https://www.510kdatabase.net/k890135/ 1989-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k890135-imx-follicle-stimulating-hormone-fsh-fda-510k.jpg K890135 - IMX FOLLICLE STIMULATING HORMONE (FSH) K890135 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Feb 1989. https://www.510kdatabase.net/k890304/ 1989-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k890304-iron-reagents-item-number-sr1017-fda-510k.jpg K890304 - IRON REAGENTS ITEM NUMBER: SR1017 K890304 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Feb 1989. https://www.510kdatabase.net/k890451/ 1989-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k890451-emitr-dau-amphetamine-class-low-fda-510k.jpg K890451 - EMIT(R) D.A.U AMPHETAMINE CLASS LOW CALIBRATOR K890451 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Feb 1989. https://www.510kdatabase.net/k890452/ 1989-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k890452-emitr-dau-amphetamine-class-medium-fda-510k.jpg K890452 - EMIT(R) D.A.U. AMPHETAMINE CLASS MEDIUM CALIBRATOR K890452 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Feb 1989. https://www.510kdatabase.net/k890501/ 1989-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k890501-second-assistant-fda-510k.jpg K890501 - SECOND ASSISTANT K890501 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3M Company. Cleared Feb 1989. https://www.510kdatabase.net/k883111/ 1989-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k883111-heomdialysis-single-patient-system-sps-fda-510k.jpg K883111 - HEOMDIALYSIS SINGLE PATIENT SYSTEM (SPS) MODEL 650 K883111 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Feb 1989. https://www.510kdatabase.net/k883660/ 1989-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k883660-dermastrip-fda-510k.jpg K883660 - DERMASTRIP K883660 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Feb 1989. https://www.510kdatabase.net/k883661/ 1989-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k883661-modified-universal-acetabular-cup-fda-510k.jpg K883661 - MODIFIED UNIVERSAL ACETABULAR CUP SYSTEM (UACS) K883661 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Feb 1989. https://www.510kdatabase.net/k890315/ 1989-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k890315-capillary-flow-dialyzers-models-ct110g-fda-510k.jpg K890315 - CAPILLARY FLOW DIALYZERS MODELS CT110G & CT190G K890315 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Feb 1989. https://www.510kdatabase.net/k885266/ 1989-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k885266-olympus-triglycerides-reagents-sr1021-fda-510k.jpg K885266 - OLYMPUS TRIGLYCERIDES REAGENTS #SR1021 K885266 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Feb 1989. https://www.510kdatabase.net/k885288/ 1989-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k885288-high-volume-profiler-data-enhancement-fda-510k.jpg K885288 - HIGH VOLUME PROFILER & DATA ENHANCEMENT PACKAGE K885288 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Feb 1989. https://www.510kdatabase.net/k885289/ 1989-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k885289-kodak-ektachem-700-analyzer-family-fda-510k.jpg K885289 - KODAK EKTACHEM 700 ANALYZER FAMILY, SOFT V5.0 K885289 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Feb 1989. https://www.510kdatabase.net/k884536/ 1989-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k884536-al-800pa-pulse-oximeter-module-fda-510k.jpg K884536 - AL-800PA PULSE OXIMETER MODULE K884536 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Feb 1989. https://www.510kdatabase.net/k885188/ 1989-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k885188-modified-rt-artrial-and-135x115f-cath-fda-510k.jpg K885188 - MODIFIED RT. ARTRIAL AND 13.5X11.5F CATH. TRAY K885188 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Feb 1989. https://www.510kdatabase.net/k883665/ 1989-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k883665-coonrad-iii-total-elbow-fda-510k.jpg K883665 - COONRAD III TOTAL ELBOW K883665 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Feb 1989. https://www.510kdatabase.net/k885178/ 1989-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k885178-kodaflex-ii-radiation-therapy-l-cassette-fda-510k.jpg K885178 - KODAFLEX II RADIATION THERAPY L CASSETTE K885178 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Feb 1989. https://www.510kdatabase.net/k885193/ 1989-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k885193-olympus-ise-module-fda-510k.jpg K885193 - OLYMPUS ISE MODULE K885193 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Feb 1989. https://www.510kdatabase.net/k885222/ 1989-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k885222-precise-ila-and-ilan-surgical-staples-fda-510k.jpg K885222 - PRECISE ILA AND ILAN SURGICAL STAPLES K885222 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3M Company. Cleared Feb 1989. https://www.510kdatabase.net/k890326/ 1989-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k890326-hip-fracture-stem-system-fenestration-fda-510k.jpg K890326 - HIP FRACTURE STEM SYSTEM - FENESTRATION PLUG K890326 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Feb 1989. https://www.510kdatabase.net/k884546/ 1989-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k884546-creatine-kinase-test-ck-item-number-fda-510k.jpg K884546 - CREATINE KINASE TEST (CK) ITEM NUMBER: 65661 K884546 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Feb 1989. https://www.510kdatabase.net/k884881/ 1989-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k884881-dade-protein-c-chromogenic-assay-fda-510k.jpg K884881 - DADE PROTEIN C CHROMOGENIC ASSAY K884881 is a FDA 510(k) cleared hematology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Feb 1989. https://www.510kdatabase.net/k884901/ 1989-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k884901-dader-prototrol-synthetic-substrate-fda-510k.jpg K884901 - DADE(R) PROTOTROL SYNTHETIC SUBSTRATE ASSAY CONTRO K884901 is a FDA 510(k) cleared hematology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Feb 1989. https://www.510kdatabase.net/k885144/ 1989-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k885144-clinistat-sgpt-alt-serum-glutamate-fda-510k.jpg K885144 - CLINISTAT SGPT (ALT) SERUM GLUTAMATE PYRUVATE TRAN K885144 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Feb 1989. https://www.510kdatabase.net/k885156/ 1989-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k885156-clinistat-sgot-ast-reagent-test-fda-510k.jpg K885156 - CLINISTAT SGOT (AST) REAGENT TEST K885156 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Feb 1989. https://www.510kdatabase.net/k885005/ 1989-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k885005-microvasive-gold-probe-fda-510k.jpg K885005 - MICROVASIVE GOLD PROBE K885005 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Boston Scientific Corp. Cleared Feb 1989. https://www.510kdatabase.net/k884102/ 1989-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k884102-modified-7-inch-continuous-infusion-sets-fda-510k.jpg K884102 - MODIFIED 7 INCH CONTINUOUS INFUSION SETS K884102 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Quinton, Inc.. Cleared Jan 1989. https://www.510kdatabase.net/k884554/ 1989-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k884554-peritoneal-catheter-stabilization-fda-510k.jpg K884554 - PERITONEAL CATHETER STABILIZATION DEVICE 5C4381 K884554 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jan 1989. https://www.510kdatabase.net/k890082/ 1989-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k890082-dispensing-pinchemotherapy-dispensing-fda-510k.jpg K890082 - DISPENSING PIN/CHEMOTHERAPY DISPENSING PIN K890082 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jan 1989. https://www.510kdatabase.net/k883718/ 1989-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k883718-merit-hi-flextm-fda-510k.jpg K883718 - MERIT HI-FLEX(TM) K883718 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Jan 1989. https://www.510kdatabase.net/k883882/ 1989-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k883882-humeral-locking-nail-system-fda-510k.jpg K883882 - HUMERAL LOCKING NAIL SYSTEM K883882 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jan 1989. https://www.510kdatabase.net/k884725/ 1989-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k884725-biasol-powder-concentrates-for-bicarb-fda-510k.jpg K884725 - BIASOL POWDER CONCENTRATES FOR BICARB. DIALYSIS K884725 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jan 1989. https://www.510kdatabase.net/k884744/ 1989-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k884744-aca-du-pont-methotrexate-mtho-method-fda-510k.jpg K884744 - ACA DU PONT METHOTREXATE (MTHO) METHOD K884744 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Jan 1989. https://www.510kdatabase.net/k884745/ 1989-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k884745-du-pont-aca-methotrexate-calibrator-fda-510k.jpg K884745 - DU PONT ACA METHOTREXATE CALIBRATOR K884745 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Jan 1989. https://www.510kdatabase.net/k884747/ 1989-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k884747-technicon-chem-1-system-acid-fda-510k.jpg K884747 - TECHNICON CHEM 1 SYSTEM ACID PHOSPHATASE (TOTAL) K884747 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Jan 1989. https://www.510kdatabase.net/k884748/ 1989-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k884748-technicon-chem-1-system-acid-phos-fda-510k.jpg K884748 - TECHNICON CHEM 1 SYSTEM ACID PHOS (PROSTATIC) K884748 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Jan 1989. https://www.510kdatabase.net/k884827/ 1989-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k884827-kodak-dental-barrier-pac-fda-510k.jpg K884827 - KODAK DENTAL BARRIER PAC K884827 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Jan 1989. https://www.510kdatabase.net/k884872/ 1989-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k884872-dideco-shiley-autotransfusion-fda-510k.jpg K884872 - DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIR K884872 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Jan 1989. https://www.510kdatabase.net/k885284/ 1989-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k885284-total-bilirubin-test-catalog-no-sr1007-fda-510k.jpg K885284 - TOTAL BILIRUBIN TEST CATALOG NO. SR1007 K885284 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jan 1989. https://www.510kdatabase.net/k885285/ 1989-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k885285-direct-bilirubin-test-catalog-no-sr1008-fda-510k.jpg K885285 - DIRECT BILIRUBIN TEST CATALOG NO. SR1008 K885285 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jan 1989. https://www.510kdatabase.net/k890045/ 1989-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k890045-model-620862096210621162126214-plis-fda-510k.jpg K890045 - MODEL 6208,6209,6210,6211,6212,6214 (PLI'S) K890045 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jan 1989. https://www.510kdatabase.net/k883967/ 1989-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k883967-beckman-liquid-stat-magnesium-reagent-fda-510k.jpg K883967 - BECKMAN LIQUID-STAT MAGNESIUM REAGENT & STANDARD K883967 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jan 1989. https://www.510kdatabase.net/k884599/ 1989-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k884599-technicon-ra-100-system-calcium-method-fda-510k.jpg K884599 - TECHNICON RA-100 SYSTEM CALCIUM METHOD K884599 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Jan 1989. https://www.510kdatabase.net/k884601/ 1989-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k884601-technicon-systems-ra-100assist-chloride-fda-510k.jpg K884601 - TECHNICON SYSTEMS RA-100/ASSIST CHLORIDE K884601 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Jan 1989. https://www.510kdatabase.net/k884702/ 1989-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k884702-easy-test-partial-thromboplastin-time-fda-510k.jpg K884702 - EASY-TEST PARTIAL THROMBOPLASTIN TIME PTT #16629 K884702 is a FDA 510(k) cleared hematology medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jan 1989. https://www.510kdatabase.net/k885296/ 1989-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k885296-miniflow-disposable-pressure-fda-510k.jpg K885296 - MINIFLOW DISPOSABLE PRESSURE TRANSDUCER 63-600F K885296 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jan 1989. https://www.510kdatabase.net/k881344/ 1989-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k881344-aca-ethyl-alcohol-alc-analytical-test-fda-510k.jpg K881344 - ACA ETHYL ALCOHOL (ALC) ANALYTICAL TEST PACKS K881344 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Jan 1989. https://www.510kdatabase.net/k883898/ 1989-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k883898-magnetom-42-sp-and-magnetom-63-sp-fda-510k.jpg K883898 - MAGNETOM 42 SP AND MAGNETOM 63 SP K883898 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 1989. https://www.510kdatabase.net/k885030/ 1989-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k885030-standard-administration-sets-fda-510k.jpg K885030 - STANDARD ADMINISTRATION SETS K885030 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Jan 1989. https://www.510kdatabase.net/k885142/ 1989-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k885142-gauze-swabs-non-sterile-fda-510k.jpg K885142 - GAUZE SWABS, NON-STERILE K885142 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jan 1989. https://www.510kdatabase.net/k890001/ 1989-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k890001-double-antibody-serum-benzodiazepines-fda-510k.jpg K890001 - DOUBLE ANTIBODY SERUM BENZODIAZEPINES K890001 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jan 1989. https://www.510kdatabase.net/k890103/ 1989-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k890103-bard-tab-ecg-monitoring-electrode-fda-510k.jpg K890103 - BARD TAB ECG MONITORING ELECTRODE K890103 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 1989. https://www.510kdatabase.net/k883327/ 1989-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k883327-clinistat-bun-blood-urea-nitrogen-fda-510k.jpg K883327 - CLINISTAT BUN (BLOOD UREA NITROGEN) REAGENT TEST K883327 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Jan 1989. https://www.510kdatabase.net/k884600/ 1989-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k884600-technicon-system-ra-100assist-magnesium-fda-510k.jpg K884600 - TECHNICON SYSTEM RA-100/ASSIST MAGNESIUM K884600 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Jan 1989. https://www.510kdatabase.net/k884703/ 1989-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k884703-total-protein-test-tp-item-65670-fda-510k.jpg K884703 - TOTAL PROTEIN TEST (TP) ITEM #65670 K884703 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jan 1989. https://www.510kdatabase.net/k884704/ 1989-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k884704-uric-acid-test-uric-item-65620-fda-510k.jpg K884704 - URIC ACID TEST (URIC) ITEM #65620 K884704 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jan 1989. https://www.510kdatabase.net/k884883/ 1989-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k884883-28-additional-allergen-modules-for-fda-510k.jpg K884883 - 28 ADDITIONAL ALLERGEN MODULES FOR ALASTAT(TM) K884883 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jan 1989. https://www.510kdatabase.net/k890002/ 1989-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k890002-coat-a-count-tm-theophylline-fda-510k.jpg K890002 - COAT-A-COUNT (TM) THEOPHYLLINE K890002 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jan 1989. https://www.510kdatabase.net/k884410/ 1989-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k884410-omnifit-total-knee-series-iiiiv-post-fda-510k.jpg K884410 - OMNIFIT TOTAL KNEE SERIES III,IV & POST. STAB. FEM K884410 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Jan 1989. https://www.510kdatabase.net/k884500/ 1989-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k884500-alta-non-reamed-tibial-rod-fda-510k.jpg K884500 - ALTA NON-REAMED TIBIAL ROD K884500 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jan 1989. https://www.510kdatabase.net/k884502/ 1989-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k884502-usci-8f-extra-large-lumen-guide-catheter-fda-510k.jpg K884502 - USCI 8F EXTRA LARGE LUMEN GUIDE CATHETER K884502 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 1989. https://www.510kdatabase.net/k883402/ 1989-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k883402-excalibur-controller-work-load-fda-510k.jpg K883402 - EXCALIBUR CONTROLLER (WORK LOAD PROGRAMMER) K883402 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Jan 1989. https://www.510kdatabase.net/k883743/ 1989-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k883743-medtronic-model-4058-pacing-lead-fda-510k.jpg K883743 - MEDTRONIC MODEL 4058 PACING LEAD K883743 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jan 1989. https://www.510kdatabase.net/k884398/ 1989-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k884398-omnifit-total-knee-series-ii-tibial-fda-510k.jpg K884398 - OMNIFIT TOTAL KNEE SERIES II TIBIAL INSERTS K884398 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Jan 1989. https://www.510kdatabase.net/k884484/ 1989-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k884484-magnetic-resonance-diagnostic-fda-510k.jpg K884484 - MAGNETIC RESONANCE DIAGNOSTIC HELMHOLTZ NECK COIL K884484 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 1989. https://www.510kdatabase.net/k884730/ 1989-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k884730-shiley-perc-tracheostomy-system-fda-510k.jpg K884730 - SHILEY PERC TRACHEOSTOMY SYSTEM K884730 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shiley, Inc.. Cleared Jan 1989. https://www.510kdatabase.net/k884948/ 1989-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k884948-model-3587a-resume-epidural-lead-fda-510k.jpg K884948 - MODEL 3587A RESUME EPIDURAL LEAD K884948 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Jan 1989. https://www.510kdatabase.net/k885022/ 1989-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k885022-magnesium-test-item-number-sr1019-fda-510k.jpg K885022 - MAGNESIUM TEST ITEM NUMBER: SR1019 K885022 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jan 1989. https://www.510kdatabase.net/k885033/ 1989-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k885033-model-3487a-pisces-epidural-lead-fda-510k.jpg K885033 - MODEL 3487A PISCES EPIDURAL LEAD K885033 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Jan 1989. https://www.510kdatabase.net/k883544/ 1989-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k883544-lyme-fast-test-fda-510k.jpg K883544 - LYME FAST TEST K883544 is a FDA 510(k) cleared microbiology medical device. Manufacturer: 3M Company. Cleared Jan 1989. https://www.510kdatabase.net/k884756/ 1989-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k884756-clinistat-glucose-reagent-test-fda-510k.jpg K884756 - CLINISTAT GLUCOSE REAGENT TEST K884756 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Jan 1989. https://www.510kdatabase.net/k884900/ 1989-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k884900-siemens-sector-35-and-50-mhz-cda-fda-510k.jpg K884900 - SIEMENS SECTOR 3.5 AND 5.0 MHZ CDA TRANSDUCER K884900 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 1989. https://www.510kdatabase.net/k884986/ 1989-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k884986-calcium-test-item-number-sr1009-fda-510k.jpg K884986 - CALCIUM TEST ITEM NUMBER: SR1009 K884986 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jan 1989. https://www.510kdatabase.net/k884987/ 1989-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k884987-urea-nitrogen-test-bun-item-number-fda-510k.jpg K884987 - UREA NITROGEN TEST (BUN) ITEM NUMBER: SR1022 K884987 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jan 1989. https://www.510kdatabase.net/k884988/ 1989-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k884988-gamma-glutamyl-transferase-test-ggt-fda-510k.jpg K884988 - GAMMA GLUTAMYL TRANSFERASE TEST (GGT) ITEM: 65664 K884988 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jan 1989. https://www.510kdatabase.net/k884065/ 1989-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k884065-cath-lab-monitoring-catheter-fda-510k.jpg K884065 - CATH LAB MONITORING CATHETER K884065 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 1989. https://www.510kdatabase.net/k884647/ 1989-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k884647-usci-adjustable-tip-guide-wire-fda-510k.jpg K884647 - USCI ADJUSTABLE TIP GUIDE WIRE K884647 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 1989. https://www.510kdatabase.net/k885101/ 1989-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k885101-medtronic-model-5411b-surgical-cable-fda-510k.jpg K885101 - MEDTRONIC MODEL 5411B SURGICAL CABLE ADAPTOR K885101 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jan 1989. https://www.510kdatabase.net/k884189/ 1989-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k884189-kodak-ektachem-clinical-chemistry-fda-510k.jpg K884189 - KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LAC) K884189 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Jan 1989. https://www.510kdatabase.net/k884376/ 1989-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k884376-alanine-aminotransferase-test-item-no-fda-510k.jpg K884376 - ALANINE AMINOTRANSFERASE TEST ITEM NO. 65652 K884376 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jan 1989. https://www.510kdatabase.net/k884382/ 1989-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k884382-amylase-test-amyl-item-number-65653-fda-510k.jpg K884382 - AMYLASE TEST (AMYL) ITEM NUMBER: 65653 K884382 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jan 1989. https://www.510kdatabase.net/k884705/ 1989-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k884705-albumin-test-alb-item-65650-fda-510k.jpg K884705 - ALBUMIN TEST (ALB) ITEM #65650 K884705 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jan 1989. https://www.510kdatabase.net/k884706/ 1989-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k884706-chloride-test-cl-item-65659-fda-510k.jpg K884706 - CHLORIDE TEST (CL) ITEM #65659 K884706 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jan 1989. https://www.510kdatabase.net/k884923/ 1989-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k884923-mixed-allergen-panel-modules-for-fda-510k.jpg K884923 - MIXED ALLERGEN PANEL MODULES FOR ALASTAT(TM) K884923 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jan 1989. https://www.510kdatabase.net/k884310/ 1989-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k884310-angiopump-tubing-set-fda-510k.jpg K884310 - ANGIOPUMP TUBING SET K884310 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Olympus Corp.. Cleared Jan 1989. https://www.510kdatabase.net/k884331/ 1989-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k884331-medtronic-model-5311b-a-v-pacing-fda-510k.jpg K884331 - MEDTRONIC MODEL 5311B A-V PACING SYSTEM ANALYZER K884331 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jan 1989. https://www.510kdatabase.net/k884395/ 1989-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k884395-hp-21362b-transesophageal-ultrasound-fda-510k.jpg K884395 - HP 21362B TRANSESOPHAGEAL ULTRASOUND IMAGING TRANS K884395 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Jan 1989. https://www.510kdatabase.net/k883580/ 1989-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k883580-universal-abc-controler-fda-510k.jpg K883580 - UNIVERSAL ABC CONTROLER K883580 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Jan 1989. https://www.510kdatabase.net/k885071/ 1989-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k885071-coat-a-count-methamphetamin-tkma1-fda-510k.jpg K885071 - COAT-A-COUNT METHAMPHETAMIN #TKMA1 K885071 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jan 1989. https://www.510kdatabase.net/k883469/ 1989-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k883469-bardr-aspiration-biopsy-system-fda-510k.jpg K883469 - BARD(R) ASPIRATION BIOPSY SYSTEM K883469 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 1989. https://www.510kdatabase.net/k884766/ 1989-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k884766-berichromr-plasminogen-fda-510k.jpg K884766 - BERICHROM(R) PLASMINOGEN K884766 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Jan 1989. https://www.510kdatabase.net/k885065/ 1989-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k885065-ige-fastscreen-s6-f1-f2-f4-f13-f14-fda-510k.jpg K885065 - IGE FASTSCREEN S6 (F1, F2, F4, F13, F14) K885065 is a FDA 510(k) cleared immunology medical device. Manufacturer: 3M Company. Cleared Jan 1989. https://www.510kdatabase.net/k885074/ 1989-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k885074-affinitytm-ferritin-immunittm-fda-510k.jpg K885074 - AFFINITY(TM) FERRITIN IMMUNIT(TM) K885074 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jan 1989. https://www.510kdatabase.net/k882225/ 1989-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k882225--amylase-eps-fda-510k.jpg K882225 - -AMYLASE EPS K882225 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jan 1989. https://www.510kdatabase.net/k884736/ 1989-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k884736-glucose-hk-test-gluc-hk-item-65665-fda-510k.jpg K884736 - GLUCOSE-HK TEST (GLUC-HK) ITEM #65665 K884736 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jan 1989. https://www.510kdatabase.net/k884544/ 1988-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k884544-dade-factor-viii-chromogenic-assay-fda-510k.jpg K884544 - DADE FACTOR VIII CHROMOGENIC ASSAY K884544 is a FDA 510(k) cleared hematology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Dec 1988. https://www.510kdatabase.net/k884551/ 1988-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k884551-dade-factor-ix-chromogenic-assay-fda-510k.jpg K884551 - DADE FACTOR IX CHROMOGENIC ASSAY K884551 is a FDA 510(k) cleared hematology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Dec 1988. https://www.510kdatabase.net/k884537/ 1988-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k884537-ae-800pa-eeg-module-fda-510k.jpg K884537 - AE-800PA EEG MODULE K884537 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Dec 1988. https://www.510kdatabase.net/k885121/ 1988-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k885121-cell-scraper-fda-510k.jpg K885121 - CELL SCRAPER K885121 is a FDA 510(k) cleared pathology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Dec 1988. https://www.510kdatabase.net/k885132/ 1988-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k885132-facsmate-sample-handling-device-fda-510k.jpg K885132 - FACSMATE SAMPLE HANDLING DEVICE K885132 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Dec 1988. https://www.510kdatabase.net/k883468/ 1988-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k883468-q5000-sthr-slope-modification-fda-510k.jpg K883468 - Q5000 ST/HR SLOPE MODIFICATION K883468 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Dec 1988. https://www.510kdatabase.net/k884274/ 1988-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k884274-buchbinder-multiflex-guidewire-fda-510k.jpg K884274 - BUCHBINDER MULTIFLEX GUIDEWIRE K884274 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Dec 1988. https://www.510kdatabase.net/k884315/ 1988-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k884315-labile-lysing-reagent-fda-510k.jpg K884315 - LABILE LYSING REAGENT K884315 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Dec 1988. https://www.510kdatabase.net/k884393/ 1988-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k884393-modified-shiley-femoral-arterial-cannula-fda-510k.jpg K884393 - MODIFIED SHILEY FEMORAL ARTERIAL CANNULA K884393 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Dec 1988. https://www.510kdatabase.net/k884397/ 1988-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k884397-pharmaseal-sterile-wound-care-dressing-fda-510k.jpg K884397 - PHARMASEAL STERILE WOUND CARE DRESSING K884397 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Baxter Healthcare Corp. Cleared Dec 1988. https://www.510kdatabase.net/k884821/ 1988-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k884821-abbott-spectrumr-bicarbonate-reagent-fda-510k.jpg K884821 - ABBOTT SPECTRUM(R) BICARBONATE REAGENT K884821 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Dec 1988. https://www.510kdatabase.net/k885062/ 1988-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k885062-modified-q-series-of-treadmills-fda-510k.jpg K885062 - MODIFIED Q-SERIES OF TREADMILLS K885062 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Quinton, Inc.. Cleared Dec 1988. https://www.510kdatabase.net/k884275/ 1988-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k884275-flexiflo-introducer-direct-stick-fda-510k.jpg K884275 - FLEXIFLO INTRODUCER (DIRECT STICK) GASTROSTOMY KIT K884275 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Abbott Laboratories. Cleared Dec 1988. https://www.510kdatabase.net/k884498/ 1988-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k884498-cotube-lh-irma-assay-fda-510k.jpg K884498 - COTUBE LH IRMA ASSAY K884498 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Dec 1988. https://www.510kdatabase.net/k884930/ 1988-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k884930-compax-model-40-400-400t-fda-510k.jpg K884930 - COMPAX MODEL 40, 400, 400T K884930 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Dec 1988. https://www.510kdatabase.net/k884104/ 1988-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k884104-uscir-hemaquettm-introducer-wobturator-fda-510k.jpg K884104 - USCI(R) HEMAQUET(TM) INTRODUCER W/OBTURATOR K884104 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 1988. https://www.510kdatabase.net/k884734/ 1988-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k884734-creatinine-test-crea-item-65663-fda-510k.jpg K884734 - CREATININE TEST (CREA) ITEM #65663 K884734 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Dec 1988. https://www.510kdatabase.net/k883606/ 1988-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k883606-model-hp-15209a-trans-combined-fda-510k.jpg K883606 - MODEL HP 15209A TRANS. COMBINED TCP02/TCPCO2 TRANS K883606 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Dec 1988. https://www.510kdatabase.net/k884063/ 1988-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k884063-bard-abg-100-intravascular-oxygen-fda-510k.jpg K884063 - BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR SYSTEM K884063 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 1988. https://www.510kdatabase.net/k884329/ 1988-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k884329-sat-2-oximetercardiac-output-computer-fda-510k.jpg K884329 - SAT-2 OXIMETER/CARDIAC OUTPUT COMPUTER K884329 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Dec 1988. https://www.510kdatabase.net/k884355/ 1988-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k884355-kodak-ektachem-clinical-chemistry-fda-510k.jpg K884355 - KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (FE) K884355 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Dec 1988. https://www.510kdatabase.net/k884735/ 1988-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k884735-phosphorus-test-phos-item-65666-fda-510k.jpg K884735 - PHOSPHORUS TEST (PHOS) ITEM #65666 K884735 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Dec 1988. https://www.510kdatabase.net/k884968/ 1988-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k884968-tdx-methadone-assay-fda-510k.jpg K884968 - TDX METHADONE ASSAY K884968 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Dec 1988. https://www.510kdatabase.net/k885006/ 1988-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k885006-chlamydiazymecommander-instrumentation-fda-510k.jpg K885006 - CHLAMYDIAZYME/COMMANDER INSTRUMENTATION K885006 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Dec 1988. https://www.510kdatabase.net/k884424/ 1988-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k884424-lyphochek-routine-urine-controls-1-2-fda-510k.jpg K884424 - LYPHOCHEK ROUTINE URINE CONTROLS 1 & 2 (HUMAN) K884424 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Dec 1988. https://www.510kdatabase.net/k884111/ 1988-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k884111-pumpettetm-fda-510k.jpg K884111 - PUMPETTE(TM) K884111 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Dec 1988. https://www.510kdatabase.net/k884377/ 1988-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k884377-aspartate-aminotransferase-test-item-fda-510k.jpg K884377 - ASPARTATE AMINOTRANSFERASE TEST ITEM NO. 65654 K884377 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Dec 1988. https://www.510kdatabase.net/k884318/ 1988-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k884318-thermosettm-closed-loop-delivery-system-fda-510k.jpg K884318 - THERMOSET(TM) CLOSED LOOP DELIVERY SYSTEM K884318 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Laboratories. Cleared Dec 1988. https://www.510kdatabase.net/k884014/ 1988-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k884014-flo-gard-vp-fda-510k.jpg K884014 - FLO-GARD VP K884014 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Dec 1988. https://www.510kdatabase.net/k883470/ 1988-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k883470-ids-1600-sample-handling-system-fda-510k.jpg K883470 - IDS-1600 SAMPLE HANDLING SYSTEM K883470 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Baxter Healthcare Corp. Cleared Dec 1988. https://www.510kdatabase.net/k883817/ 1988-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k883817-accuchek-ii-freedomtm-monitoring-system-fda-510k.jpg K883817 - ACCUCHEK II FREEDOM(TM) MONITORING SYSTEM K883817 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Dec 1988. https://www.510kdatabase.net/k884013/ 1988-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k884013-roche-reagent-for-chloride-fda-510k.jpg K884013 - ROCHE REAGENT FOR CHLORIDE K884013 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Dec 1988. https://www.510kdatabase.net/k883825/ 1988-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k883825-modified-sanders-bi-papeasy-fda-510k.jpg K883825 - MODIFIED SANDERS BI-PAPEASY K883825 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Dec 1988. https://www.510kdatabase.net/k884290/ 1988-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k884290-baxter-disposable-circumcision-tray-fda-510k.jpg K884290 - BAXTER DISPOSABLE CIRCUMCISION TRAY K884290 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Dec 1988. https://www.510kdatabase.net/k884291/ 1988-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k884291-cook-hysterocathtm-fda-510k.jpg K884291 - COOK HYSTEROCATH(TM) K884291 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Cook, Inc.. Cleared Dec 1988. https://www.510kdatabase.net/k884596/ 1988-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k884596-abbott-a-gent-lipase-reagent-fda-510k.jpg K884596 - ABBOTT A-GENT LIPASE REAGENT K884596 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Dec 1988. https://www.510kdatabase.net/k884597/ 1988-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k884597-beckman-lambda-light-chain-reagent-fda-510k.jpg K884597 - BECKMAN LAMBDA LIGHT CHAIN REAGENT K884597 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Dec 1988. https://www.510kdatabase.net/k883723/ 1988-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k883723-flexible-myocardial-biopsy-forceps-fda-510k.jpg K883723 - FLEXIBLE MYOCARDIAL BIOPSY FORCEPS K883723 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Dec 1988. https://www.510kdatabase.net/k884005/ 1988-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k884005-endocardial-pacing-leads-anchoring-fda-510k.jpg K884005 - ENDOCARDIAL PACING LEADS-ANCHORING SLEEVE MODIFIED K884005 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Dec 1988. https://www.510kdatabase.net/k884200/ 1988-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k884200-usci-tandem-adapter-fda-510k.jpg K884200 - USCI TANDEM ADAPTER K884200 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 1988. https://www.510kdatabase.net/k884207/ 1988-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k884207-resubmitted-abbott-testpacktm-hcg-combo-fda-510k.jpg K884207 - RESUBMITTED ABBOTT TESTPACK(TM) HCG COMBO K884207 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Dec 1988. https://www.510kdatabase.net/k884566/ 1988-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k884566-vision-lyte-tm-potassium-fda-510k.jpg K884566 - VISION LYTE (TM) POTASSIUM K884566 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Dec 1988. https://www.510kdatabase.net/k883122/ 1988-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k883122-amk-total-knee-system-without-porocoat-fda-510k.jpg K883122 - AMK TOTAL KNEE SYSTEM WITHOUT POROCOAT K883122 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Dec 1988. https://www.510kdatabase.net/k884610/ 1988-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k884610-interlocking-intramedullary-nails-fda-510k.jpg K884610 - INTERLOCKING INTRAMEDULLARY NAILS K884610 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Dec 1988. https://www.510kdatabase.net/k883547/ 1988-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k883547-ge-mr-max-system-fda-510k.jpg K883547 - GE MR MAX SYSTEM K883547 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Nov 1988. https://www.510kdatabase.net/k883745/ 1988-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k883745-irma-counttm-fsh-wmonoclonal-antibodies-fda-510k.jpg K883745 - IRMA-COUNT(TM) FSH W/MONOCLONAL ANTIBODIES K883745 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Nov 1988. https://www.510kdatabase.net/k883780/ 1988-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k883780-xtrel-model-number-3425-fda-510k.jpg K883780 - XTREL, MODEL NUMBER 3425 K883780 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Nov 1988. https://www.510kdatabase.net/k883964/ 1988-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k883964-airlife-misty-neb-medication-system-fda-510k.jpg K883964 - AIRLIFE MISTY NEB MEDICATION SYSTEM W/FILTER K883964 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Nov 1988. https://www.510kdatabase.net/k884302/ 1988-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k884302-edwards-arthroscopic-leg-holder-fda-510k.jpg K884302 - EDWARDS ARTHROSCOPIC LEG HOLDER K884302 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Baxter Healthcare Corp. Cleared Nov 1988. https://www.510kdatabase.net/k884658/ 1988-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k884658-zimmer-beaded-threaded-acetabular-cup-fda-510k.jpg K884658 - ZIMMER BEADED THREADED ACETABULAR CUP K884658 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Nov 1988. https://www.510kdatabase.net/k882751/ 1988-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k882751-glass-ionomer-base-fda-510k.jpg K882751 - GLASS IONOMER BASE K882751 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Nov 1988. https://www.510kdatabase.net/k883585/ 1988-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k883585-technicon-assist-potassium-fda-510k.jpg K883585 - TECHNICON ASSIST POTASSIUM K883585 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Nov 1988. https://www.510kdatabase.net/k883586/ 1988-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k883586-technicon-ra-100-system-potassium-fda-510k.jpg K883586 - TECHNICON RA-100 SYSTEM POTASSIUM K883586 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Nov 1988. https://www.510kdatabase.net/k883730/ 1988-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k883730-tdx-benzodiazepines-serum-fda-510k.jpg K883730 - TDX BENZODIAZEPINES SERUM K883730 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1988. https://www.510kdatabase.net/k883889/ 1988-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k883889-transesophageal-echo-transducer-fda-510k.jpg K883889 - TRANSESOPHAGEAL ECHO TRANSDUCER K883889 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: General Electric Co.. Cleared Nov 1988. https://www.510kdatabase.net/k883890/ 1988-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k883890-du-pont-dimension-pseudocholinesterase-fda-510k.jpg K883890 - DU PONT DIMENSION PSEUDOCHOLINESTERASE METHOD K883890 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Nov 1988. https://www.510kdatabase.net/k883891/ 1988-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k883891-du-pont-dimension-pseudocholinesterase-fda-510k.jpg K883891 - DU PONT DIMENSION PSEUDOCHOLINESTERASE VERIFIER K883891 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Nov 1988. https://www.510kdatabase.net/k883962/ 1988-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k883962-roche-reagent-for-inorganic-phosphorus-fda-510k.jpg K883962 - ROCHE REAGENT FOR INORGANIC PHOSPHORUS K883962 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Nov 1988. https://www.510kdatabase.net/k884138/ 1988-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k884138-abbott-imx-lh-fda-510k.jpg K884138 - ABBOTT IMX LH K884138 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1988. https://www.510kdatabase.net/k884433/ 1988-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k884433-technicon-assistr-calcium-method-fda-510k.jpg K884433 - TECHNICON ASSIST(R) CALCIUM METHOD K884433 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Nov 1988. https://www.510kdatabase.net/k884369/ 1988-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k884369-posterior-cervical-spine-surface-coil-fda-510k.jpg K884369 - POSTERIOR CERVICAL SPINE SURFACE COIL M1085AM K884369 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Nov 1988. https://www.510kdatabase.net/k883202/ 1988-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k883202-ultrasonic-imaging-catheter-fda-510k.jpg K883202 - ULTRASONIC IMAGING CATHETER K883202 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Boston Scientific Corp. Cleared Nov 1988. https://www.510kdatabase.net/k883662/ 1988-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k883662-berichromr-antithrombin-iii-fda-510k.jpg K883662 - BERICHROM(R) ANTITHROMBIN III K883662 is a FDA 510(k) cleared hematology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Nov 1988. https://www.510kdatabase.net/k884062/ 1988-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k884062-magnetom-m-h-42-63-sequences-fda-510k.jpg K884062 - MAGNETOM (M, H, 42, 63) SEQUENCES K884062 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 1988. https://www.510kdatabase.net/k883694/ 1988-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k883694-tensiometer-fda-510k.jpg K883694 - TENSIOMETER K883694 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Nov 1988. https://www.510kdatabase.net/k884419/ 1988-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k884419-technicon-ra-phenobarbital-fda-510k.jpg K884419 - TECHNICON RA-PHENOBARBITAL K884419 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Nov 1988. https://www.510kdatabase.net/k884572/ 1988-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k884572-rpmi-1640-hybri-max-prod-no-r5382-fda-510k.jpg K884572 - RPMI-1640 HYBRI-MAX, PROD. NO. R5382 K884572 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Nov 1988. https://www.510kdatabase.net/k884573/ 1988-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k884573-hbss-wo-calc-chlormag-sulfphen-redsb-fda-510k.jpg K884573 - HBSS W/O CALC CHLOR/MAG SULF/PHEN RED/SB NO. H4891 K884573 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Nov 1988. https://www.510kdatabase.net/k884574/ 1988-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k884574-dme-hams-nutrient-mixture-prod-no-d9785-fda-510k.jpg K884574 - DME & HAM'S NUTRIENT MIXTURE, PROD. NO. D9785 K884574 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Nov 1988. https://www.510kdatabase.net/k884626/ 1988-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k884626-modified-sliding-reconstitution-device-fda-510k.jpg K884626 - MODIFIED SLIDING RECONSTITUTION DEVICE K884626 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Nov 1988. https://www.510kdatabase.net/k883872/ 1988-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k883872-cp-head-coil-260mm-cv-transmit-receive-fda-510k.jpg K883872 - CP HEAD COIL & 260MM (CV) TRANSMIT-RECEIVE COIL K883872 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 1988. https://www.510kdatabase.net/k883994/ 1988-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k883994-vista-mr-2055-hp-system-fda-510k.jpg K883994 - VISTA MR 2055 HP SYSTEM K883994 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Nov 1988. https://www.510kdatabase.net/k883577/ 1988-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k883577-bard-infusor-pump-fda-510k.jpg K883577 - BARD INFUSOR PUMP K883577 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 1988. https://www.510kdatabase.net/k880738/ 1988-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k880738-model-2331t-patient-programmer-fda-510k.jpg K880738 - MODEL 2331T PATIENT PROGRAMMER K880738 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Nov 1988. https://www.510kdatabase.net/k883755/ 1988-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k883755-modified-spectrax-sxsxt-pasyspasys-st-fda-510k.jpg K883755 - MODIFIED SPECTRAX SX/SXT & PASYS/PASYS ST MODELS K883755 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Nov 1988. https://www.510kdatabase.net/k884215/ 1988-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k884215-minix-8340-8341-8342-minix-st-8330-8331-fda-510k.jpg K884215 - MINIX 8340, 8341, 8342 MINIX-ST 8330, 8331 K884215 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Nov 1988. https://www.510kdatabase.net/k884512/ 1988-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k884512-beaverr-handle-fda-510k.jpg K884512 - BEAVER(R) HANDLE K884512 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Nov 1988. https://www.510kdatabase.net/k883724/ 1988-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k883724-gemini-femoral-hip-prosthesis-fda-510k.jpg K883724 - GEMINI FEMORAL HIP PROSTHESIS K883724 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Nov 1988. https://www.510kdatabase.net/k884276/ 1988-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k884276-beckman-kappa-light-chain-reagent-fda-510k.jpg K884276 - BECKMAN KAPPA LIGHT CHAIN REAGENT K884276 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Nov 1988. https://www.510kdatabase.net/k882061/ 1988-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k882061-olympus-gf-um3eu-m3-fda-510k.jpg K882061 - OLYMPUS GF-UM3/EU-M3 K882061 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Corp.. Cleared Nov 1988. https://www.510kdatabase.net/k883561/ 1988-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k883561-bardr-ureteral-stent-wsuture-fda-510k.jpg K883561 - BARD(R) URETERAL STENT W/SUTURE K883561 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 1988. https://www.510kdatabase.net/k882923/ 1988-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k882923-kodak-surecell-chlamydia-test-kit-fda-510k.jpg K882923 - KODAK SURECELL CHLAMYDIA TEST KIT K882923 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Eastman Kodak Company. Cleared Nov 1988. https://www.510kdatabase.net/k883019/ 1988-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k883019-saturne-42-and-43-fda-510k.jpg K883019 - SATURNE 42 AND 43 K883019 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Nov 1988. https://www.510kdatabase.net/k883816/ 1988-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k883816-shoulder-microstructured-humeral-fda-510k.jpg K883816 - SHOULDER MICROSTRUCTURED HUMERAL PROSTHESIS K883816 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Nov 1988. https://www.510kdatabase.net/k883972/ 1988-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k883972-magnesium-reagent-magon-sulfonate-fda-510k.jpg K883972 - MAGNESIUM REAGENT (MAGON SULFONATE) K883972 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Nov 1988. https://www.510kdatabase.net/k884021/ 1988-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k884021-emds-glucose-gluc-testpacks-no-6769795-fda-510k.jpg K884021 - EMDS GLUCOSE (GLUC) TESTPACKS, NO. 67697/95 K884021 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Nov 1988. https://www.510kdatabase.net/k884548/ 1988-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k884548-lactate-dehydrogenase-test-ld-item-no-fda-510k.jpg K884548 - LACTATE DEHYDROGENASE TEST (LD) ITEM NO. 65668 K884548 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Nov 1988. https://www.510kdatabase.net/k884549/ 1988-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k884549-alkaline-phosphatase-test-alp-item-no-fda-510k.jpg K884549 - ALKALINE PHOSPHATASE TEST (ALP) ITEM NO. 65651 K884549 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Nov 1988. https://www.510kdatabase.net/k882254/ 1988-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k882254-oec-7102-ecgnibp-monitor-fda-510k.jpg K882254 - OEC-7102 ECG/NIBP MONITOR K882254 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Nov 1988. https://www.510kdatabase.net/k883973/ 1988-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k883973-model-vy-800ra-optional-accessory-to-fda-510k.jpg K883973 - MODEL VY-800RA OPTIONAL ACCESSORY TO BSM 8500A K883973 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Nov 1988. https://www.510kdatabase.net/k883664/ 1988-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k883664-lum-vascular-procedure-system-b5200a-fda-510k.jpg K883664 - LUM VASCULAR PROCEDURE SYSTEM #B5200A K883664 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Nov 1988. https://www.510kdatabase.net/k881307/ 1988-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k881307-olv-1100-fda-510k.jpg K881307 - OLV 1100 K881307 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Nov 1988. https://www.510kdatabase.net/k883481/ 1988-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k883481-hp-77025a77030a-ultra-systemhp-77020cv-fda-510k.jpg K883481 - HP 77025A/77030A ULTRA. SYSTEM/HP 77020CV UPGRADE K883481 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Nov 1988. https://www.510kdatabase.net/k883579/ 1988-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k883579-coronary-guide-wire-fda-510k.jpg K883579 - CORONARY GUIDE WIRE K883579 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Nov 1988. https://www.510kdatabase.net/k884217/ 1988-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k884217-technicon-dpa-1-analyte-alpha-1-acid-fda-510k.jpg K884217 - TECHNICON DPA-1 ANALYTE ALPHA 1 ACID GLYCOPROTEIN K884217 is a FDA 510(k) cleared immunology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Nov 1988. https://www.510kdatabase.net/k884342/ 1988-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k884342-novapath-specimen-collection-kit-fda-510k.jpg K884342 - NOVAPATH SPECIMEN COLLECTION KIT K884342 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bio-Rad. Cleared Nov 1988. https://www.510kdatabase.net/k882978/ 1988-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k882978-q4000-option-for-q4000-fda-510k.jpg K882978 - Q4000 OPTION FOR Q4000 K882978 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Nov 1988. https://www.510kdatabase.net/k883747/ 1988-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k883747-irma-counttm-prolactin-wmonoclonal-fda-510k.jpg K883747 - IRMA-COUNT(TM) PROLACTIN W/MONOCLONAL ANTIBODIES K883747 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Nov 1988. https://www.510kdatabase.net/k882629/ 1988-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k882629-directigen-respiratory-syncytial-virus-fda-510k.jpg K882629 - DIRECTIGEN RESPIRATORY SYNCYTIAL VIRUS TEST KIT K882629 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1988. https://www.510kdatabase.net/k883267/ 1988-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k883267-irma-count-tm-shbg-sex-hormorne-bind-fda-510k.jpg K883267 - IRMA-COUNT (TM) SHBG (SEX HORMORNE BIND GLOBULIN) K883267 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Oct 1988. https://www.510kdatabase.net/k883646/ 1988-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k883646-behring-turbitimer-fda-510k.jpg K883646 - BEHRING TURBITIMER K883646 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Oct 1988. https://www.510kdatabase.net/k883371/ 1988-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k883371-multi-allergen-ige-fastscreen-v-fda-510k.jpg K883371 - MULTI-ALLERGEN IGE FASTSCREEN V (T1,T3,T5,T7,T10) K883371 is a FDA 510(k) cleared immunology medical device. Manufacturer: 3M Company. Cleared Oct 1988. https://www.510kdatabase.net/k883907/ 1988-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k883907-sceptorpette-system-fda-510k.jpg K883907 - SCEPTORPETTE SYSTEM K883907 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1988. https://www.510kdatabase.net/k882486/ 1988-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k882486-lyphochek-unassayed-chem-control-human-fda-510k.jpg K882486 - LYPHOCHEK UNASSAYED CHEM. CONTROL (HUMAN) I AND II K882486 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Oct 1988. https://www.510kdatabase.net/k883104/ 1988-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k883104-chem-1-uibc-iron-binding-capacity-test-fda-510k.jpg K883104 - CHEM 1 UIBC (IRON BINDING CAPACITY TEST) K883104 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Oct 1988. https://www.510kdatabase.net/k883173/ 1988-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k883173-model-27084-uromat-for-urological-fda-510k.jpg K883173 - MODEL 27084 UROMAT FOR UROLOGICAL IRRIGATION K883173 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Oct 1988. https://www.510kdatabase.net/k883321/ 1988-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k883321-clinistat-dry-chem-analyzeruric-acid-fda-510k.jpg K883321 - CLINISTAT DRY CHEM ANALYZER/URIC ACID REAGENT TEST K883321 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Heraeus Kulzer, Inc.. Cleared Oct 1988. https://www.510kdatabase.net/k883453/ 1988-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k883453-roche-reagent-for-calcium-fda-510k.jpg K883453 - ROCHE REAGENT FOR CALCIUM K883453 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Oct 1988. https://www.510kdatabase.net/k883479/ 1988-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k883479-stratus-total-triiodothyronine-t3-fda-510k.jpg K883479 - STRATUS TOTAL TRIIODOTHYRONINE T3 FLUORO. ENZYME K883479 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Baxter Healthcare Corp. Cleared Oct 1988. https://www.510kdatabase.net/k883525/ 1988-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k883525-oxalate-reagent-fda-510k.jpg K883525 - OXALATE REAGENT K883525 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Oct 1988. https://www.510kdatabase.net/k883971/ 1988-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k883971-qlia-t-uptake-assay-fda-510k.jpg K883971 - QLIA T UPTAKE ASSAY K883971 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1988. https://www.510kdatabase.net/k883110/ 1988-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k883110-bard-ureteroscopic-device-fda-510k.jpg K883110 - BARD URETEROSCOPIC DEVICE K883110 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 1988. https://www.510kdatabase.net/k883239/ 1988-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k883239-capd-ultravioletuv-germicidal-exchange-fda-510k.jpg K883239 - CAPD ULTRAVIOLET(U.V.) GERMICIDAL EXCHANGE DEV SYS K883239 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Oct 1988. https://www.510kdatabase.net/k883534/ 1988-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k883534-capillary-flow-dialyzers-models-ht80-fda-510k.jpg K883534 - CAPILLARY FLOW DIALYZERS MODELS HT.80 & HT.100 K883534 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Oct 1988. https://www.510kdatabase.net/k883644/ 1988-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k883644-capillary-flow-dialyzers-models-ht-130-fda-510k.jpg K883644 - CAPILLARY FLOW DIALYZERS MODELS HT. 130 & 170 K883644 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Oct 1988. https://www.510kdatabase.net/k882234/ 1988-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k882234-johnson-johnson-modular-total-knee-fda-510k.jpg K882234 - JOHNSON & JOHNSON MODULAR TOTAL KNEE PROSTHESIS K882234 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Oct 1988. https://www.510kdatabase.net/k883707/ 1988-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k883707-tdx-amphetaminemethamphetamine-ii-fda-510k.jpg K883707 - TDX AMPHETAMINE/METHAMPHETAMINE II K883707 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1988. https://www.510kdatabase.net/k883482/ 1988-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k883482-vista-mr-2055-hp-system-fda-510k.jpg K883482 - VISTA MR 2055 HP SYSTEM K883482 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Oct 1988. https://www.510kdatabase.net/k883519/ 1988-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k883519-fast-and-ce-fast-mri-sequences-for-nmr-fda-510k.jpg K883519 - FAST AND CE-FAST MRI SEQUENCES (FOR NMR 1000) K883519 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Oct 1988. https://www.510kdatabase.net/k884101/ 1988-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k884101-du-pont-dimension-c-reactive-protein-fda-510k.jpg K884101 - DU PONT DIMENSION C-REACTIVE PROTEIN CALIBRATOR K884101 is a FDA 510(k) cleared immunology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Oct 1988. https://www.510kdatabase.net/k883955/ 1988-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k883955-single-filtm-syringe-fda-510k.jpg K883955 - SINGLE-FIL(TM) SYRINGE K883955 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1988. https://www.510kdatabase.net/k883174/ 1988-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k883174-multi-med-infusion-catheter-and-kit-fda-510k.jpg K883174 - MULTI-MED INFUSION CATHETER AND KIT DOUBLE/TRIPLE K883174 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Oct 1988. https://www.510kdatabase.net/k881810/ 1988-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k881810-medtronic-model-4951p-fda-510k.jpg K881810 - MEDTRONIC MODEL 4951P K881810 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Oct 1988. https://www.510kdatabase.net/k883326/ 1988-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k883326-technicon-ratm-systems-magnesium-fda-510k.jpg K883326 - TECHNICON RA(TM) SYSTEMS - MAGNESIUM K883326 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Oct 1988. https://www.510kdatabase.net/k883921/ 1988-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k883921-omnifit-threaded-acetabular-comp-fda-510k.jpg K883921 - OMNIFIT THREADED ACETABULAR COMP. W/MICRO COATING K883921 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Oct 1988. https://www.510kdatabase.net/k883946/ 1988-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k883946-vision-creatine-kinase-fda-510k.jpg K883946 - VISION CREATINE KINASE K883946 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1988. https://www.510kdatabase.net/k874923/ 1988-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k874923-pca-modular-total-knee-universal-fda-510k.jpg K874923 - PCA MODULAR TOTAL KNEE-UNIVERSAL TIBIAL BASEPLATE K874923 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Oct 1988. https://www.510kdatabase.net/k883798/ 1988-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k883798-sceptor-gram-positive-breakpointid-panel-fda-510k.jpg K883798 - SCEPTOR GRAM-POSITIVE BREAKPOINT/ID PANEL K883798 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1988. https://www.510kdatabase.net/k883800/ 1988-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k883800-sceptor-gram-negative-breakpointid-panel-fda-510k.jpg K883800 - SCEPTOR GRAM-NEGATIVE BREAKPOINT/ID PANEL K883800 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1988. https://www.510kdatabase.net/k882378/ 1988-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k882378-p-7-computed-tomography-system-fda-510k.jpg K882378 - P-7 COMPUTED TOMOGRAPHY SYSTEM K882378 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Oct 1988. https://www.510kdatabase.net/k883460/ 1988-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k883460-focus-total-hip-system-fda-510k.jpg K883460 - FOCUS TOTAL HIP SYSTEM K883460 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Oct 1988. https://www.510kdatabase.net/k883731/ 1988-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k883731-tdx-cannabinoids-gs-fda-510k.jpg K883731 - TDX CANNABINOIDS-GS K883731 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1988. https://www.510kdatabase.net/k883920/ 1988-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k883920-emit-dau-low-calibrator-a-medium-cali-a-fda-510k.jpg K883920 - EMIT D.A.U. LOW CALIBRATOR A & MEDIUM CALI. A K883920 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Oct 1988. https://www.510kdatabase.net/k884022/ 1988-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k884022-emit-dau-monoclonal-amphetaminemethamphe-fda-510k.jpg K884022 - EMIT D.A.U. MONOCLONAL AMPHETAMINE/METHAMPHETAMINE K884022 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Oct 1988. https://www.510kdatabase.net/k883520/ 1988-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k883520-05-t-compact-magnet-for-its-vista-mr-fda-510k.jpg K883520 - 0.5 T COMPACT MAGNET FOR ITS VISTA MR 2055 HP SYST K883520 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Oct 1988. https://www.510kdatabase.net/k880599/ 1988-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k880599-pocket-manometer-fda-510k.jpg K880599 - POCKET MANOMETER K880599 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1988. https://www.510kdatabase.net/k881983/ 1988-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k881983-howmedica-precision-osteolock-femoral-fda-510k.jpg K881983 - HOWMEDICA PRECISION OSTEOLOCK FEMORAL COMPONENT K881983 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Oct 1988. https://www.510kdatabase.net/k883051/ 1988-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k883051-usci-soft-tip-angiographic-catheter-fda-510k.jpg K883051 - USCI SOFT-TIP ANGIOGRAPHIC CATHETER K883051 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 1988. https://www.510kdatabase.net/k883297/ 1988-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k883297-hewlett-packard-modles-78354a78352-fda-510k.jpg K883297 - HEWLETT-PACKARD MODLES 78354A/78352 PULSE OXIMETER K883297 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Oct 1988. https://www.510kdatabase.net/k884064/ 1988-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k884064-bard-multi-tac-ecg-monitoring-electrode-fda-510k.jpg K884064 - BARD MULTI-TAC ECG MONITORING ELECTRODE K884064 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 1988. https://www.510kdatabase.net/k882966/ 1988-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k882966-model-320-fetalmaternal-telemetry-system-fda-510k.jpg K882966 - MODEL 320 FETAL/MATERNAL TELEMETRY SYSTEM K882966 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Oct 1988. https://www.510kdatabase.net/k881966/ 1988-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k881966-electrophysiology-electrode-cath-fda-510k.jpg K881966 - ELECTROPHYSIOLOGY ELECTRODE CATH. W/SILVER/SILVER K881966 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 1988. https://www.510kdatabase.net/k883009/ 1988-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k883009-non-coring-needles-fda-510k.jpg K883009 - NON-CORING NEEDLES K883009 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Quinton, Inc.. Cleared Oct 1988. https://www.510kdatabase.net/k881177/ 1988-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k881177-model-meb-5304-evoked-potential-fda-510k.jpg K881177 - MODEL MEB-5304 EVOKED POTENTIAL & ELECTRO. RECORD K881177 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Sep 1988. https://www.510kdatabase.net/k881863/ 1988-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k881863-rep-glyco-system-fda-510k.jpg K881863 - REP GLYCO SYSTEM K881863 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Sep 1988. https://www.510kdatabase.net/k882799/ 1988-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k882799-helena-colocare-fda-510k.jpg K882799 - HELENA COLOCARE K882799 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Sep 1988. https://www.510kdatabase.net/k882967/ 1988-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k882967-bone-fixation-wire-fda-510k.jpg K882967 - BONE FIXATION WIRE K882967 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Baxter Healthcare Corp. Cleared Sep 1988. https://www.510kdatabase.net/k883607/ 1988-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k883607-peel-away-introducer-for-ventricular-fda-510k.jpg K883607 - PEEL-AWAY INTRODUCER FOR VENTRICULAR CATHETER K883607 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Sep 1988. https://www.510kdatabase.net/k883374/ 1988-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k883374-bard-biopsy-needle-guidance-device-fda-510k.jpg K883374 - BARD BIOPSY NEEDLE GUIDANCE DEVICE K883374 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Sep 1988. https://www.510kdatabase.net/k882771/ 1988-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k882771-extracorporeal-membrane-oxygenation-fda-510k.jpg K882771 - EXTRACORPOREAL MEMBRANE OXYGENATION CATHETER K882771 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Sep 1988. https://www.510kdatabase.net/k883320/ 1988-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k883320-monojectr-trace-element-blood-fda-510k.jpg K883320 - MONOJECT(R) TRACE ELEMENT BLOOD COLLECTION TUBE K883320 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sherwood Medical Co.. Cleared Sep 1988. https://www.510kdatabase.net/k883551/ 1988-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k883551-sceptor-staphylococcus-micid-panel-80325-fda-510k.jpg K883551 - SCEPTOR STAPHYLOCOCCUS MIC/ID PANEL #80325 K883551 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1988. https://www.510kdatabase.net/k883330/ 1988-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k883330-basic-heater-cooler-unit-115100v-16-02-fda-510k.jpg K883330 - BASIC HEATER-COOLER UNIT, 115/100V 16-02-20 K883330 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Sep 1988. https://www.510kdatabase.net/k883331/ 1988-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k883331-basic-heater-cooler-unit-wmast-115110v-fda-510k.jpg K883331 - BASIC HEATER-COOLER UNIT W/MAST, 115/110V 16-21-10 K883331 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Sep 1988. https://www.510kdatabase.net/k883332/ 1988-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k883332-mast-for-basic-heater-cooler-unit-16-fda-510k.jpg K883332 - MAST FOR BASIC HEATER-COOLER UNIT 16-09-00 K883332 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Sep 1988. https://www.510kdatabase.net/k883548/ 1988-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k883548-sceptor-streptococcus-micid-panel-80323-fda-510k.jpg K883548 - SCEPTOR STREPTOCOCCUS MIC/ID PANEL #80323 K883548 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1988. https://www.510kdatabase.net/k883549/ 1988-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k883549-sceptor-streptococcus-mic-panel-80322-fda-510k.jpg K883549 - SCEPTOR STREPTOCOCCUS MIC PANEL #80322 K883549 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1988. https://www.510kdatabase.net/k883550/ 1988-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k883550-sceptor-staphylococcus-mic-80324-fda-510k.jpg K883550 - SCEPTOR STAPHYLOCOCCUS MIC #80324 K883550 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1988. https://www.510kdatabase.net/k883552/ 1988-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k883552-sceptor-pseudomonas-plus-mic-panel-cat-fda-510k.jpg K883552 - SCEPTOR PSEUDOMONAS PLUS MIC PANEL CAT.# 80328 K883552 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1988. https://www.510kdatabase.net/k883553/ 1988-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k883553-sceptor-resistant-gram-negative-mic-fda-510k.jpg K883553 - SCEPTOR RESISTANT GRAM-NEGATIVE MIC PANEL #80331 K883553 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1988. https://www.510kdatabase.net/k883554/ 1988-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k883554-sceptor-pseudomonas-plus-micid-panel-fda-510k.jpg K883554 - SCEPTOR PSEUDOMONAS PLUS MIC/ID PANEL #80329 K883554 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1988. https://www.510kdatabase.net/k883555/ 1988-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k883555-sceptor-resistant-gram-negative-micid-fda-510k.jpg K883555 - SCEPTOR RESISTANT GRAM-NEGATIVE MIC/ID #80332 K883555 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1988. https://www.510kdatabase.net/k883638/ 1988-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k883638-safesite-injection-site-and-blunt-fda-510k.jpg K883638 - SAFESITE INJECTION SITE AND BLUNT CANNULA K883638 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Sep 1988. https://www.510kdatabase.net/k881341/ 1988-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k881341-nova-litetm-sa-fda-510k.jpg K881341 - NOVA LITE(TM) SA K881341 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Sep 1988. https://www.510kdatabase.net/k883179/ 1988-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k883179-hip-fracture-stem-system-fda-510k.jpg K883179 - HIP FRACTURE STEM SYSTEM K883179 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Sep 1988. https://www.510kdatabase.net/k883378/ 1988-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k883378-vista-mr-2055-hp-system-fda-510k.jpg K883378 - VISTA MR 2055 HP SYSTEM K883378 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Sep 1988. https://www.510kdatabase.net/k883492/ 1988-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k883492-technicon-dpa-1-immunoglobulin-a-fda-510k.jpg K883492 - TECHNICON DPA-1 IMMUNOGLOBULIN A K883492 is a FDA 510(k) cleared immunology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Sep 1988. https://www.510kdatabase.net/k883493/ 1988-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k883493-technicon-dpa-1-immunoglobulin-m-fda-510k.jpg K883493 - TECHNICON DPA-1 IMMUNOGLOBULIN M K883493 is a FDA 510(k) cleared immunology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Sep 1988. https://www.510kdatabase.net/k883515/ 1988-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k883515-du-pont-dimension-c-reactive-protein-fda-510k.jpg K883515 - DU PONT DIMENSION C-REACTIVE PROTEIN METHOD K883515 is a FDA 510(k) cleared immunology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Sep 1988. https://www.510kdatabase.net/k883616/ 1988-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k883616-specific-allergen-modules-for-alastattm-fda-510k.jpg K883616 - SPECIFIC ALLERGEN MODULES FOR ALASTAT(TM) K883616 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Sep 1988. https://www.510kdatabase.net/k883031/ 1988-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k883031-q-cath-rm-fda-510k.jpg K883031 - Q-CATH RM K883031 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Sep 1988. https://www.510kdatabase.net/k883181/ 1988-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k883181-synchron-cx4cx5-clinical-chemistry-fda-510k.jpg K883181 - SYNCHRON CX4/CX5 CLINICAL CHEMISTRY ANALYZER REAGE K883181 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Sep 1988. https://www.510kdatabase.net/k883210/ 1988-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k883210-emit-r-hva-negative-urine-fda-510k.jpg K883210 - EMIT (R) HVA NEGATIVE URINE K883210 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Sep 1988. https://www.510kdatabase.net/k882556/ 1988-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k882556-becton-dickinson-pca-infuser-software-fda-510k.jpg K882556 - BECTON DICKINSON PCA INFUSER - SOFTWARE MODIFI. K882556 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1988. https://www.510kdatabase.net/k882821/ 1988-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k882821-vitrabond-light-cure-glass-ionomer-liner-fda-510k.jpg K882821 - VITRABOND LIGHT CURE GLASS IONOMER LINER K882821 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Sep 1988. https://www.510kdatabase.net/k881697/ 1988-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k881697-breast-lesion-localization-needle-fda-510k.jpg K881697 - BREAST LESION LOCALIZATION NEEDLE K881697 is a FDA 510(k) cleared radiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1988. https://www.510kdatabase.net/k882052/ 1988-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k882052-omega-nvtm-balloon-dilatation-catheter-fda-510k.jpg K882052 - OMEGA NV(TM) BALLOON DILATATION CATHETER K882052 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Sep 1988. https://www.510kdatabase.net/k882394/ 1988-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k882394-medtronic-epidural-catheter-kit-model-fda-510k.jpg K882394 - MEDTRONIC EPIDURAL CATHETER KIT MODEL 8716 K882394 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Medtronic Vascular. Cleared Sep 1988. https://www.510kdatabase.net/k883209/ 1988-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k883209-technicon-ra-100tm-system-fda-510k.jpg K883209 - TECHNICON RA-100(TM) SYSTEM K883209 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Sep 1988. https://www.510kdatabase.net/k883353/ 1988-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k883353-iq-hdl-cholesterol-fda-510k.jpg K883353 - IQ HDL CHOLESTEROL K883353 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1988. https://www.510kdatabase.net/k883441/ 1988-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k883441-visionr-prothrombin-time-fda-510k.jpg K883441 - VISION(R) PROTHROMBIN TIME K883441 is a FDA 510(k) cleared hematology medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1988. https://www.510kdatabase.net/k881469/ 1988-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k881469-angioscope-wintegrated-irrigating-fda-510k.jpg K881469 - ANGIOSCOPE W/INTEGRATED IRRIGATING CHANNEL K881469 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Sep 1988. https://www.510kdatabase.net/k883254/ 1988-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k883254-multinex-monitor-modification-fda-510k.jpg K883254 - MULTINEX MONITOR (MODIFICATION) K883254 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Datascope Corp.. Cleared Sep 1988. https://www.510kdatabase.net/k883190/ 1988-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k883190-dade-tdm-control-fda-510k.jpg K883190 - DADE TDM CONTROL K883190 is a FDA 510(k) cleared pathology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Sep 1988. https://www.510kdatabase.net/k883459/ 1988-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k883459-double-antibody-benzodiazpines-kbzd1-fda-510k.jpg K883459 - DOUBLE ANTIBODY BENZODIAZPINES #KBZD1, KBZD5 K883459 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Sep 1988. https://www.510kdatabase.net/k882451/ 1988-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k882451-olympus-reply-chemistry-analyzer-fda-510k.jpg K882451 - OLYMPUS REPLY CHEMISTRY ANALYZER K882451 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Sep 1988. https://www.510kdatabase.net/k883076/ 1988-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k883076-gram-negative-gram-positive-miccombo-fda-510k.jpg K883076 - GRAM NEGATIVE & GRAM POSITIVE MIC/COMBO PANELS K883076 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Sep 1988. https://www.510kdatabase.net/k883273/ 1988-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k883273-dhbti-allergen-ige-fastscreen-iv-fda-510k.jpg K883273 - DHBTI-ALLERGEN IGE FASTSCREEN IV (G1,G5,G12,G13) K883273 is a FDA 510(k) cleared immunology medical device. Manufacturer: 3M Company. Cleared Sep 1988. https://www.510kdatabase.net/k883349/ 1988-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k883349-qlia-immunochemistry-system-fda-510k.jpg K883349 - QLIA IMMUNOCHEMISTRY SYSTEM K883349 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1988. https://www.510kdatabase.net/k883394/ 1988-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k883394-gram-negative-and-gram-positive-fda-510k.jpg K883394 - GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS K883394 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Sep 1988. https://www.510kdatabase.net/k883491/ 1988-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k883491-technicon-dpa-1-apolipoprotein-b-fda-510k.jpg K883491 - TECHNICON DPA-1 APOLIPOPROTEIN B K883491 is a FDA 510(k) cleared immunology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Sep 1988. https://www.510kdatabase.net/k883494/ 1988-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k883494-technicon-dpa-1-immunoglobulin-g-fda-510k.jpg K883494 - TECHNICON DPA-1 IMMUNOGLOBULIN G K883494 is a FDA 510(k) cleared immunology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Sep 1988. https://www.510kdatabase.net/k882145/ 1988-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k882145-photo-curing-light-fda-510k.jpg K882145 - PHOTO-CURING LIGHT K882145 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Sep 1988. https://www.510kdatabase.net/k882330/ 1988-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k882330-bard-baim-turi-balloon-diagnostic-fda-510k.jpg K882330 - BARD BAIM-TURI BALLOON DIAGNOSTIC PACING CATHETER K882330 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Sep 1988. https://www.510kdatabase.net/k882442/ 1988-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k882442-rk2000-k-thermia-system-fda-510k.jpg K882442 - RK2000 K-THERMIA SYSTEM K882442 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Sep 1988. https://www.510kdatabase.net/k883203/ 1988-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k883203-model-5866-34a-pacemaker-lead-adaptor-fda-510k.jpg K883203 - MODEL 5866-34A PACEMAKER LEAD ADAPTOR K883203 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Sep 1988. https://www.510kdatabase.net/k883602/ 1988-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k883602-biopore-vs1-endocardial-inter-implant-fda-510k.jpg K883602 - BIOPORE VS.1 ENDOCARDIAL INTER IMPLANT PACING LEAD K883602 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Sep 1988. https://www.510kdatabase.net/k882496/ 1988-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k882496-abuscreenr-ontraktm-for-morphine-fda-510k.jpg K882496 - ABUSCREEN(R) ONTRAK(TM) FOR MORPHINE K882496 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Sep 1988. https://www.510kdatabase.net/k883521/ 1988-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k883521-cr-gating-for-its-vista-mr-20552055-up-fda-510k.jpg K883521 - C/R GATING FOR ITS VISTA MR 2055/2055 UP & HP SYS K883521 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Sep 1988. https://www.510kdatabase.net/k880878/ 1988-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k880878-cx250-mobile-gamma-camera-dcs-console-fda-510k.jpg K880878 - CX250 MOBILE GAMMA CAMERA & DCS CONSOLE K880878 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Sep 1988. https://www.510kdatabase.net/k882757/ 1988-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k882757-argyle-autotransfusion-bag-fda-510k.jpg K882757 - ARGYLE AUTOTRANSFUSION BAG K882757 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sherwood Medical Co.. Cleared Sep 1988. https://www.510kdatabase.net/k875203/ 1988-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k875203-du-pont-ebna-igg-antibody-elisa-kit-fda-510k.jpg K875203 - DU PONT EBNA-IGG ANTIBODY ELISA KIT K875203 is a FDA 510(k) cleared microbiology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Aug 1988. https://www.510kdatabase.net/k881715/ 1988-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k881715-28200-series-micro-arthro-sterile-disp-fda-510k.jpg K881715 - 28200 SERIES MICRO-ARTHRO. STERILE DISP. BLADES K881715 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Aug 1988. https://www.510kdatabase.net/k881750/ 1988-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k881750-normal-humeral-prosthesis-fda-510k.jpg K881750 - NORMAL HUMERAL PROSTHESIS K881750 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Aug 1988. https://www.510kdatabase.net/k882913/ 1988-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k882913-dtr-analyzer-fda-510k.jpg K882913 - DTR ANALYZER K882913 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1988. https://www.510kdatabase.net/k882914/ 1988-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k882914-vista-instrument-fda-510k.jpg K882914 - VISTA INSTRUMENT K882914 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1988. https://www.510kdatabase.net/k882313/ 1988-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k882313-emit-dau-cannabinoid-50-ng-assay-fda-510k.jpg K882313 - EMIT D.A.U. CANNABINOID 50 NG ASSAY & CALIBRATORS K882313 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Aug 1988. https://www.510kdatabase.net/k882795/ 1988-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k882795-dader-ck-mb-immunoassay-control-fda-510k.jpg K882795 - DADE(R) CK-MB IMMUNOASSAY CONTROL K882795 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Baxter Healthcare Corp. Cleared Aug 1988. https://www.510kdatabase.net/k882909/ 1988-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k882909-sceptor-new-antimicrobial-agent-rifampin-fda-510k.jpg K882909 - SCEPTOR - NEW ANTIMICROBIAL AGENT: RIFAMPIN K882909 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1988. https://www.510kdatabase.net/k882961/ 1988-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k882961-emit-qst-carbamazepine-assay-fda-510k.jpg K882961 - EMIT QST CARBAMAZEPINE ASSAY K882961 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Aug 1988. https://www.510kdatabase.net/k880314/ 1988-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k880314-hysteroscope-autonom-4992-fda-510k.jpg K880314 - HYSTEROSCOPE AUTONOM 4992 K880314 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Aug 1988. https://www.510kdatabase.net/k882452/ 1988-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k882452-medtronic-models-40574557-endocardial-fda-510k.jpg K882452 - MEDTRONIC MODELS 4057/4557 ENDOCARDIAL PACING LEAD K882452 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Aug 1988. https://www.510kdatabase.net/k883484/ 1988-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k883484-owrens-veronal-buffer-fda-510k.jpg K883484 - OWREN'S VERONAL BUFFER K883484 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Aug 1988. https://www.510kdatabase.net/k881834/ 1988-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k881834-model-ssd-870-diagnostic-ultrasound-fda-510k.jpg K881834 - MODEL SSD-870 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM K881834 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Aug 1988. https://www.510kdatabase.net/k873121/ 1988-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k873121-ge-integrated-diagnostic-system-drsprs-fda-510k.jpg K873121 - GE INTEGRATED DIAGNOSTIC SYSTEM (DRS.PRS) K873121 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Aug 1988. https://www.510kdatabase.net/k881775/ 1988-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k881775-bd-microfine-iv-pen-injector-fda-510k.jpg K881775 - BD MICROFINE IV PEN INJECTOR K881775 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1988. https://www.510kdatabase.net/k882766/ 1988-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k882766-emds-acetaminophen-calibrator-no-6763695-fda-510k.jpg K882766 - EMDS ACETAMINOPHEN CALIBRATOR NO. 67636/95 K882766 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Aug 1988. https://www.510kdatabase.net/k880301/ 1988-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k880301-3000-physiological-monitor-fda-510k.jpg K880301 - 3000 PHYSIOLOGICAL MONITOR K880301 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Aug 1988. https://www.510kdatabase.net/k880722/ 1988-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k880722-coating-for-wire-guide-fda-510k.jpg K880722 - COATING FOR WIRE GUIDE K880722 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Aug 1988. https://www.510kdatabase.net/k882079/ 1988-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k882079-respironics-infant-secureeasy-fda-510k.jpg K882079 - RESPIRONIC'S INFANT SECUREEASY K882079 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Aug 1988. https://www.510kdatabase.net/k882454/ 1988-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k882454-luhr-micro-system-fda-510k.jpg K882454 - LUHR MICRO SYSTEM K882454 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Aug 1988. https://www.510kdatabase.net/k882910/ 1988-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k882910-sceptor-new-antimicrobial-agent-fda-510k.jpg K882910 - SCEPTOR NEW ANTIMICROBIAL AGENT: AMPICILLIN/SULBAC K882910 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1988. https://www.510kdatabase.net/k882911/ 1988-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k882911-sceptor-exten-of-concentration-range-fda-510k.jpg K882911 - SCEPTOR EXTEN. OF CONCENTRATION RANGE: PENCILLIN K882911 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1988. https://www.510kdatabase.net/k882912/ 1988-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k882912-sceptor-new-antimicrobial-agent-imipenem-fda-510k.jpg K882912 - SCEPTOR NEW ANTIMICROBIAL AGENT: IMIPENEM K882912 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1988. https://www.510kdatabase.net/k882581/ 1988-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k882581-ct-max-640-b7940-jaje-fda-510k.jpg K882581 - CT MAX 640 #B7940 JA/JE K882581 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Aug 1988. https://www.510kdatabase.net/k883075/ 1988-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k883075-fastidious-inoculum-broth-fda-510k.jpg K883075 - FASTIDIOUS INOCULUM BROTH K883075 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Aug 1988. https://www.510kdatabase.net/k882482/ 1988-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k882482-triad-orthodontic-gel-fda-510k.jpg K882482 - TRIAD ORTHODONTIC GEL K882482 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Aug 1988. https://www.510kdatabase.net/k882690/ 1988-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k882690-imprint-vinyl-polysiloxane-impression-fda-510k.jpg K882690 - IMPRINT VINYL POLYSILOXANE IMPRESSION MATERIAL K882690 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Aug 1988. https://www.510kdatabase.net/k881899/ 1988-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k881899-specific-allergen-modules-for-fda-510k.jpg K881899 - SPECIFIC ALLERGEN MODULES FOR ALASTAT(TM) IGE SYS. K881899 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Aug 1988. https://www.510kdatabase.net/k882334/ 1988-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k882334-abbott-spectrum-simulstat-glucosebun-fda-510k.jpg K882334 - ABBOTT SPECTRUM SIMULSTAT GLUCOSE/BUN REAGENT K882334 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1988. https://www.510kdatabase.net/k882448/ 1988-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k882448-multilumen-central-venous-cath-fda-510k.jpg K882448 - MULTILUMEN CENTRAL VENOUS CATH. W/VITACUFF DEVICE K882448 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1988. https://www.510kdatabase.net/k882614/ 1988-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k882614-monojectr-snap-over-safety-cap-fda-510k.jpg K882614 - MONOJECT(R) SNAP-OVER SAFETY CAP K882614 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sherwood Medical Co.. Cleared Aug 1988. https://www.510kdatabase.net/k882155/ 1988-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k882155-cotube-hcg-irma-test-fda-510k.jpg K882155 - COTUBE HCG IRMA TEST K882155 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Aug 1988. https://www.510kdatabase.net/k882228/ 1988-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k882228-revised-double-antibody-amphetamine-fda-510k.jpg K882228 - REVISED DOUBLE ANTIBODY AMPHETAMINE K882228 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Aug 1988. https://www.510kdatabase.net/k882368/ 1988-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k882368-rep-hdl-electrophoresis-method-fda-510k.jpg K882368 - REP HDL ELECTROPHORESIS METHOD K882368 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Aug 1988. https://www.510kdatabase.net/k882611/ 1988-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k882611-emit-hva-barbiturate-assay-fda-510k.jpg K882611 - EMIT HVA BARBITURATE ASSAY K882611 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Aug 1988. https://www.510kdatabase.net/k882719/ 1988-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k882719-easy-test-emit-acetaminophen-actm-no-fda-510k.jpg K882719 - EASY-TEST EMIT ACETAMINOPHEN (ACTM) NO. 16653 K882719 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Aug 1988. https://www.510kdatabase.net/k882812/ 1988-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k882812-omnifit-acetabular-shell-cement-spacer-fda-510k.jpg K882812 - OMNIFIT ACETABULAR SHELL CEMENT SPACER SYSTEM K882812 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Aug 1988. https://www.510kdatabase.net/k882819/ 1988-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k882819-emit-hva-cannabinoid-100-ng-assay-fda-510k.jpg K882819 - EMIT HVA CANNABINOID 100 NG ASSAY K882819 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Aug 1988. https://www.510kdatabase.net/k883013/ 1988-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k883013-imx-ckmb-fda-510k.jpg K883013 - IMX CKMB K883013 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1988. https://www.510kdatabase.net/k882153/ 1988-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k882153-technicon-dpa-1tm-system-fda-510k.jpg K882153 - TECHNICON DPA-1(TM) SYSTEM K882153 is a FDA 510(k) cleared immunology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Aug 1988. https://www.510kdatabase.net/k882965/ 1988-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k882965-krebs-henseleit-bicarbonate-buffer-no-fda-510k.jpg K882965 - KREBS-HENSELEIT BICARBONATE BUFFER NO. K3753 K882965 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Aug 1988. https://www.510kdatabase.net/k880155/ 1988-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k880155-millergalante-precoat-unicompartmental-fda-510k.jpg K880155 - MILLER/GALANTE PRECOAT UNICOMPARTMENTAL KNEE K880155 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Aug 1988. https://www.510kdatabase.net/k880437/ 1988-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k880437-visionr-total-bilirubin-with-a-fda-510k.jpg K880437 - VISION(R) TOTAL BILIRUBIN WITH A NEONATAL CLAIM K880437 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1988. https://www.510kdatabase.net/k883018/ 1988-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k883018-auto-suture-disp-endoscopic-surg-clip-fda-510k.jpg K883018 - AUTO SUTURE DISP. ENDOSCOPIC SURG. CLIP APPLIER K883018 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Aug 1988. https://www.510kdatabase.net/k880575/ 1988-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k880575-cardiolife-tec-7300-woptional-fda-510k.jpg K880575 - CARDIOLIFE TEC-7300 W/OPTIONAL ACCESSORIES K880575 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Aug 1988. https://www.510kdatabase.net/k881405/ 1988-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k881405-siemens-intravaginal-transducer-fda-510k.jpg K881405 - SIEMENS INTRAVAGINAL TRANSDUCER K881405 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 1988. https://www.510kdatabase.net/k881781/ 1988-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k881781-catheter-strap-fda-510k.jpg K881781 - CATHETER STRAP K881781 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Aug 1988. https://www.510kdatabase.net/k881941/ 1988-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k881941-emit-hva-opiate-assay-fda-510k.jpg K881941 - EMIT HVA OPIATE ASSAY K881941 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Aug 1988. https://www.510kdatabase.net/k882095/ 1988-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k882095-modification-of-behring-rapimat-iit-fda-510k.jpg K882095 - MODIFICATION OF BEHRING RAPIMAT II/T K882095 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Aug 1988. https://www.510kdatabase.net/k882589/ 1988-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k882589-emit-hva-amphetamine-assay-fda-510k.jpg K882589 - EMIT HVA AMPHETAMINE ASSAY K882589 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Aug 1988. https://www.510kdatabase.net/k882051/ 1988-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k882051-bio-rad-hemoglobin-detector-fda-510k.jpg K882051 - BIO-RAD HEMOGLOBIN DETECTOR K882051 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bio-Rad. Cleared Aug 1988. https://www.510kdatabase.net/k882222/ 1988-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k882222-determin-hemoglobin-alchi-perf-liq-fda-510k.jpg K882222 - DETERMIN HEMOGLOBIN ALC/HI PERF LIQ CHROMATOGRAPHY K882222 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bio-Rad. Cleared Aug 1988. https://www.510kdatabase.net/k881814/ 1988-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k881814-abuscreenr-ontraktm-for-thc-fda-510k.jpg K881814 - ABUSCREEN(R) ONTRAK(TM) FOR THC K881814 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jul 1988. https://www.510kdatabase.net/k881815/ 1988-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k881815-abuscreenr-ontraktm-for-cocaine-fda-510k.jpg K881815 - ABUSCREEN(R) ONTRAK(TM) FOR COCAINE K881815 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jul 1988. https://www.510kdatabase.net/k881817/ 1988-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k881817-abuscreenr-ontraktm-for-amphetamines-fda-510k.jpg K881817 - ABUSCREEN(R) ONTRAK(TM) FOR AMPHETAMINES K881817 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jul 1988. https://www.510kdatabase.net/k873452/ 1988-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k873452-modified-model-ssd-650-system-fda-510k.jpg K873452 - MODIFIED MODEL SSD-650 SYSTEM K873452 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Jul 1988. https://www.510kdatabase.net/k880612/ 1988-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k880612-cordis-pta-dilatation-catheters-fda-510k.jpg K880612 - CORDIS PTA DILATATION CATHETERS K880612 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Jul 1988. https://www.510kdatabase.net/k881816/ 1988-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k881816-abuscreenr-ontraktm-for-barbiturates-fda-510k.jpg K881816 - ABUSCREEN(R) ONTRAK(TM) FOR BARBITURATES K881816 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jul 1988. https://www.510kdatabase.net/k882097/ 1988-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k882097-tunneling-stylet-fda-510k.jpg K882097 - TUNNELING STYLET K882097 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Jul 1988. https://www.510kdatabase.net/k882796/ 1988-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k882796-slip-coattm-catheters-fda-510k.jpg K882796 - SLIP-COAT(TM) CATHETERS K882796 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Jul 1988. https://www.510kdatabase.net/k883014/ 1988-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k883014-modified-intended-use-of-monoject-bone-fda-510k.jpg K883014 - MODIFIED INTENDED USE OF MONOJECT BONE MARROW NEED K883014 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sherwood Medical Co.. Cleared Jul 1988. https://www.510kdatabase.net/k875088/ 1988-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k875088-xenon-ct-fda-510k.jpg K875088 - XENON CT K875088 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 1988. https://www.510kdatabase.net/k880783/ 1988-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k880783-abbott-testpack-chlamydia-fda-510k.jpg K880783 - ABBOTT TESTPACK CHLAMYDIA K880783 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Jul 1988. https://www.510kdatabase.net/k881703/ 1988-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k881703-3m-carpal-tunnel-fda-510k.jpg K881703 - 3M CARPAL TUNNEL K881703 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 3M Company. Cleared Jul 1988. https://www.510kdatabase.net/k882680/ 1988-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k882680-alternate-blood-port-design-for-addit-fda-510k.jpg K882680 - ALTERNATE BLOOD PORT DESIGN FOR ADDIT. MEMB. OF CA K882680 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jul 1988. https://www.510kdatabase.net/k882542/ 1988-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k882542-lyphochek-unassayed-chemistry-control-fda-510k.jpg K882542 - LYPHOCHEK UNASSAYED CHEMISTRY CONTROL (BOVINE)I/II K882542 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Jul 1988. https://www.510kdatabase.net/k881982/ 1988-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k881982-pca-modular-total-knee-sys-all-plas-fda-510k.jpg K881982 - PCA MODULAR TOTAL KNEE SYS-ALL PLAS PATELLAR COMP K881982 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jul 1988. https://www.510kdatabase.net/k881749/ 1988-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881749-straight-line-finish-for-implantable-fda-510k.jpg K881749 - STRAIGHT-LINE FINISH FOR IMPLANTABLE PULSE GENERA. K881749 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Jul 1988. https://www.510kdatabase.net/k882299/ 1988-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k882299-sceptor-gram-negative-urine-isolate-fda-510k.jpg K882299 - SCEPTOR GRAM-NEGATIVE URINE ISOLATE MIC/ID PANEL K882299 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jul 1988. https://www.510kdatabase.net/k882501/ 1988-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k882501-accufibrintm-blood-collection-system-fda-510k.jpg K882501 - ACCUFIBRIN(TM) BLOOD COLLECTION SYSTEM AF100 K882501 is a FDA 510(k) cleared hematology medical device. Manufacturer: Terumo Medical Corp.. Cleared Jul 1988. https://www.510kdatabase.net/k880352/ 1988-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k880352-mtx-generator-fda-510k.jpg K880352 - MTX GENERATOR K880352 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Jul 1988. https://www.510kdatabase.net/k881716/ 1988-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k881716-sceptor-new-antimicrobial-agent-cefaclor-fda-510k.jpg K881716 - SCEPTOR - NEW ANTIMICROBIAL AGENT: CEFACLOR K881716 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jul 1988. https://www.510kdatabase.net/k881831/ 1988-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k881831-ws-800r-thermal-array-recorder-fda-510k.jpg K881831 - WS 800R THERMAL ARRAY RECORDER K881831 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Jul 1988. https://www.510kdatabase.net/k882017/ 1988-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k882017-respironics-suctioneasy-fda-510k.jpg K882017 - RESPIRONICS SUCTIONEASY K882017 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Jul 1988. https://www.510kdatabase.net/k882535/ 1988-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k882535-abbott-testpacktm-chlamydia-positive-fda-510k.jpg K882535 - ABBOTT TESTPACK(TM) CHLAMYDIA POSITIVE CONTROL K882535 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Jul 1988. https://www.510kdatabase.net/k882455/ 1988-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k882455-extended-life-capd-solution-transfer-fda-510k.jpg K882455 - EXTENDED LIFE CAPD SOLUTION TRANSFER SET IC4373 K882455 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jul 1988. https://www.510kdatabase.net/k882498/ 1988-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k882498-extended-life-capd-transfer-set-5c4444-fda-510k.jpg K882498 - EXTENDED LIFE CAPD TRANSFER SET 5C4444 K882498 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jul 1988. https://www.510kdatabase.net/k881908/ 1988-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k881908-tracertm-ii-blood-glucose-system-fda-510k.jpg K881908 - TRACER(TM) II BLOOD GLUCOSE SYSTEM K881908 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jul 1988. https://www.510kdatabase.net/k881942/ 1988-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k881942-emit-hva-cocaine-metabolite-assay-fda-510k.jpg K881942 - EMIT HVA COCAINE METABOLITE ASSAY K881942 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jul 1988. https://www.510kdatabase.net/k882179/ 1988-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k882179-emit-hva-phencyclidine-assay-fda-510k.jpg K882179 - EMIT HVA PHENCYCLIDINE ASSAY K882179 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jul 1988. https://www.510kdatabase.net/k882300/ 1988-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k882300-sceptor-enteric-mic-panel-revised-488-fda-510k.jpg K882300 - SCEPTOR ENTERIC MIC PANEL (REVISED 4/88) K882300 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jul 1988. https://www.510kdatabase.net/k882301/ 1988-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k882301-sceptor-enteric-micid-panel-revised-488-fda-510k.jpg K882301 - SCEPTOR ENTERIC MIC/ID PANEL (REVISED 4/88) K882301 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jul 1988. https://www.510kdatabase.net/k882534/ 1988-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k882534-abbott-testpacktm-gonorrhea-positive-fda-510k.jpg K882534 - ABBOTT TESTPACK(TM) GONORRHEA POSITIVE CONTROL K882534 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Jul 1988. https://www.510kdatabase.net/k875204/ 1988-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k875204-du-pont-vca-igm-antibody-elisa-kit-fda-510k.jpg K875204 - DU PONT VCA-IGM ANTIBODY ELISA KIT K875204 is a FDA 510(k) cleared microbiology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Jul 1988. https://www.510kdatabase.net/k881503/ 1988-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k881503-modified-dade-compre-electrophoresis-fda-510k.jpg K881503 - MODIFIED DADE COMPRE. ELECTROPHORESIS CONTROL K881503 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jul 1988. https://www.510kdatabase.net/k881639/ 1988-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k881639-kodak-ektachem-clinical-chemistry-fda-510k.jpg K881639 - KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (PROT) K881639 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Jul 1988. https://www.510kdatabase.net/k881692/ 1988-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k881692-dideco-shiley-fluid-collection-bag-fda-510k.jpg K881692 - DIDECO-SHILEY FLUID COLLECTION BAG K881692 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shiley, Inc.. Cleared Jul 1988. https://www.510kdatabase.net/k881846/ 1988-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k881846-sceptor-new-antimicrobial-agent-fda-510k.jpg K881846 - SCEPTOR- NEW ANTIMICROBIAL AGENT: NORFLOXACIN K881846 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jul 1988. https://www.510kdatabase.net/k881852/ 1988-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k881852-rep-sp-electrophoresis-system-cat-no-fda-510k.jpg K881852 - REP SP ELECTROPHORESIS SYSTEM CAT NO. 3170 K881852 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Jul 1988. https://www.510kdatabase.net/k881943/ 1988-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k881943-emit-hva-calibrator-kit-fda-510k.jpg K881943 - EMIT HVA CALIBRATOR KIT K881943 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jul 1988. https://www.510kdatabase.net/k881944/ 1988-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k881944-emit-hva-control-kit-fda-510k.jpg K881944 - EMIT HVA CONTROL KIT K881944 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jul 1988. https://www.510kdatabase.net/k882446/ 1988-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k882446-alpha1antitrypsin-for-technicon-dpa-fda-510k.jpg K882446 - ALPHA1ANTITRYPSIN FOR TECHNICON DPA-1(TM) SYSTEM K882446 is a FDA 510(k) cleared immunology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Jul 1988. https://www.510kdatabase.net/k882620/ 1988-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k882620-apolipoprotein-for-the-technicon-dpa-fda-510k.jpg K882620 - APOLIPOPROTEIN FOR THE TECHNICON DPA-1(TM) SYSTEM K882620 is a FDA 510(k) cleared immunology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Jul 1988. https://www.510kdatabase.net/k882621/ 1988-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k882621-complement-c4-for-the-technicon-dpa-fda-510k.jpg K882621 - COMPLEMENT C4 FOR THE TECHNICON DPA-1(TM) SYSTEM K882621 is a FDA 510(k) cleared immunology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Jul 1988. https://www.510kdatabase.net/k882622/ 1988-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k882622-ceruloplasmin-for-the-technicon-dpa-fda-510k.jpg K882622 - CERULOPLASMIN FOR THE TECHNICON DPA-1(TM) SYSTEM K882622 is a FDA 510(k) cleared immunology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Jul 1988. https://www.510kdatabase.net/k882623/ 1988-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k882623-properdin-factor-b-for-technicon-dpa-fda-510k.jpg K882623 - PROPERDIN FACTOR B FOR TECHNICON DPA-1(TM) SYSTEM K882623 is a FDA 510(k) cleared immunology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Jul 1988. https://www.510kdatabase.net/k864893/ 1988-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k864893-anti-cytokeratin-monoclonal-antibody-fda-510k.jpg K864893 - ANTI-CYTOKERATIN MONOCLONAL ANTIBODY K864893 is a FDA 510(k) cleared pathology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jul 1988. https://www.510kdatabase.net/k881733/ 1988-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k881733-shiley-femoral-coronary-perfusion-fda-510k.jpg K881733 - SHILEY FEMORAL CORONARY PERFUSION CATHETER K881733 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Jul 1988. https://www.510kdatabase.net/k882233/ 1988-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k882233-tdx-r-digoxin-nxt-fda-510k.jpg K882233 - TDX (R) DIGOXIN NXT K882233 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jul 1988. https://www.510kdatabase.net/k881691/ 1988-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k881691-preassembled-surgical-wash-set-fda-510k.jpg K881691 - PREASSEMBLED SURGICAL WASH SET 122,175,225,375AA K881691 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Jul 1988. https://www.510kdatabase.net/k881734/ 1988-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k881734-shiley-femoral-left-ventricular-vent-fda-510k.jpg K881734 - SHILEY FEMORAL LEFT VENTRICULAR VENT CATHETER K881734 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Jul 1988. https://www.510kdatabase.net/k882294/ 1988-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k882294-emit-convenience-pack-tobramycin-assay-fda-510k.jpg K882294 - EMIT CONVENIENCE PACK: TOBRAMYCIN ASSAY K882294 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jul 1988. https://www.510kdatabase.net/k882343/ 1988-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k882343-terumo-sensibeadtm-eia-estradiol-kit-fda-510k.jpg K882343 - TERUMO SENSIBEAD(TM) EIA ESTRADIOL KIT K882343 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Terumo Medical Corp.. Cleared Jul 1988. https://www.510kdatabase.net/k881367/ 1988-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k881367-acl-systems-100-200-300-and-300-fda-510k.jpg K881367 - ACL SYSTEMS 100, 200, 300 AND 300+ COAGULATION SYS K881367 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jun 1988. https://www.510kdatabase.net/k881683/ 1988-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k881683-dideco-shiley-autotrans-bt-795aa-fda-510k.jpg K881683 - DIDECO-SHILEY AUTOTRANS BT 795/AA K881683 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shiley, Inc.. Cleared Jun 1988. https://www.510kdatabase.net/k881988/ 1988-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k881988-3m-wound-contact-material-product-563x-fda-510k.jpg K881988 - 3M WOUND CONTACT MATERIAL, PRODUCT #563X K881988 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3M Company. Cleared Jun 1988. https://www.510kdatabase.net/k882185/ 1988-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k882185-electronic-insufflator-model-no-205460-fda-510k.jpg K882185 - ELECTRONIC INSUFFLATOR, MODEL NO. 2054.60 K882185 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Jun 1988. https://www.510kdatabase.net/k882277/ 1988-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k882277-abbott-testpacktm-rsv-positive-control-fda-510k.jpg K882277 - ABBOTT TESTPACK(TM) RSV POSITIVE CONTROL K882277 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1988. https://www.510kdatabase.net/k880061/ 1988-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k880061-fuller-irflex-fiber-optic-surgical-fda-510k.jpg K880061 - FULLER IRFLEX FIBER OPTIC SURGICAL LASER SYSTEM K880061 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1988. https://www.510kdatabase.net/k880145/ 1988-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k880145-lyphochek-therapeutic-drug-monitoring-fda-510k.jpg K880145 - LYPHOCHEK THERAPEUTIC DRUG MONITORING CONTROL K880145 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bio-Rad. Cleared Jun 1988. https://www.510kdatabase.net/k880570/ 1988-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k880570-denver-pleuro-peritoneal-shunt-fda-510k.jpg K880570 - DENVER PLEURO-PERITONEAL SHUNT K880570 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Jun 1988. https://www.510kdatabase.net/k880733/ 1988-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k880733-bard-pca-ii-infusion-pump-fda-510k.jpg K880733 - BARD PCA II INFUSION PUMP K880733 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jun 1988. https://www.510kdatabase.net/k881989/ 1988-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k881989-lyphochek-urine-toxicology-control-fda-510k.jpg K881989 - LYPHOCHEK URINE TOXICOLOGY CONTROL K881989 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bio-Rad. Cleared Jun 1988. https://www.510kdatabase.net/k881990/ 1988-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k881990-lyphochek-urine-toxicology-control-low-fda-510k.jpg K881990 - LYPHOCHEK URINE TOXICOLOGY CONTROL - LOW K881990 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bio-Rad. Cleared Jun 1988. https://www.510kdatabase.net/k881991/ 1988-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k881991-lyphochek-urine-toxicology-control-fda-510k.jpg K881991 - LYPHOCHEK URINE TOXICOLOGY CONTROL - NEGATIVE K881991 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bio-Rad. Cleared Jun 1988. https://www.510kdatabase.net/k882007/ 1988-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k882007-extended-life-injection-site-fda-510k.jpg K882007 - EXTENDED LIFE INJECTION SITE K882007 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jun 1988. https://www.510kdatabase.net/k882163/ 1988-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k882163-helena-rep-gel-processor-fda-510k.jpg K882163 - HELENA REP GEL PROCESSOR K882163 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Jun 1988. https://www.510kdatabase.net/k873606/ 1988-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k873606-modified-cope-suture-anchor-fda-510k.jpg K873606 - MODIFIED COPE SUTURE ANCHOR K873606 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook, Inc.. Cleared Jun 1988. https://www.510kdatabase.net/k881321/ 1988-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k881321-bloodsolution-set-wpressure-pump-fda-510k.jpg K881321 - BLOOD/SOLUTION SET W/PRESSURE PUMP K881321 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jun 1988. https://www.510kdatabase.net/k882320/ 1988-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k882320-kodak-ektascan-laser-printer-adapter-fda-510k.jpg K882320 - KODAK EKTASCAN LASER PRINTER ADAPTER, MODEL M6/M8 K882320 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Jun 1988. https://www.510kdatabase.net/k882335/ 1988-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k882335-disposable-syringe-fda-510k.jpg K882335 - DISPOSABLE SYRINGE K882335 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jun 1988. https://www.510kdatabase.net/k881449/ 1988-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k881449-edwards-duromedics-leaflet-probe-model-fda-510k.jpg K881449 - EDWARDS-DUROMEDICS LEAFLET PROBE, MODEL 1116 K881449 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jun 1988. https://www.510kdatabase.net/k881215/ 1988-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k881215-centrasil-silicone-elastomer-central-fda-510k.jpg K881215 - CENTRASIL SILICONE ELASTOMER CENTRAL VENOUS CATH K881215 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jun 1988. https://www.510kdatabase.net/k881234/ 1988-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k881234-venovalvetm-fda-510k.jpg K881234 - VENOVALVE(TM) K881234 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1988. https://www.510kdatabase.net/k880289/ 1988-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k880289-datascope-percor-stat-mil-95-fr-intra-fda-510k.jpg K880289 - DATASCOPE PERCOR STAT-MIL 9.5 FR INTRA-AORTIC BALL K880289 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Jun 1988. https://www.510kdatabase.net/k880419/ 1988-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k880419-model-800-ob-data-archival-system-fda-510k.jpg K880419 - MODEL 800 O.B. DATA ARCHIVAL SYSTEM K880419 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Jun 1988. https://www.510kdatabase.net/k881855/ 1988-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k881855-emit-convenience-pack-t-uptake-assay-fda-510k.jpg K881855 - EMIT CONVENIENCE PACK: T-UPTAKE ASSAY K881855 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Jun 1988. https://www.510kdatabase.net/k881877/ 1988-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k881877-cobas-eiatm-photometer-fda-510k.jpg K881877 - COBAS EIA(TM) PHOTOMETER K881877 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jun 1988. https://www.510kdatabase.net/k881891/ 1988-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k881891-iq-hdl-cholesterol-fda-510k.jpg K881891 - IQ HDL CHOLESTEROL K881891 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jun 1988. https://www.510kdatabase.net/k881073/ 1988-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k881073-shiley-femoral-cannulae-introducer-kit-fda-510k.jpg K881073 - SHILEY FEMORAL CANNULAE INTRODUCER KIT K881073 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Jun 1988. https://www.510kdatabase.net/k881352/ 1988-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k881352-right-atrial-catheter-insertion-tray-fda-510k.jpg K881352 - RIGHT ATRIAL CATHETER INSERTION TRAY K881352 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Jun 1988. https://www.510kdatabase.net/k881340/ 1988-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k881340-nova-litetm-autoantibody-controls-fda-510k.jpg K881340 - NOVA LITE(TM) AUTOANTIBODY CONTROLS K881340 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Jun 1988. https://www.510kdatabase.net/k881774/ 1988-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k881774-prolactin-mab-solid-phase-component-fda-510k.jpg K881774 - PROLACTIN MAB SOLID PHASE COMPONENT SYSTEM K881774 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jun 1988. https://www.510kdatabase.net/k881677/ 1988-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k881677-bun-kinetic-fda-510k.jpg K881677 - BUN (KINETIC) K881677 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jun 1988. https://www.510kdatabase.net/k881693/ 1988-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k881693-terumo-sensibead-eia-progesterone-kit-fda-510k.jpg K881693 - TERUMO SENSIBEAD EIA PROGESTERONE KIT K881693 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Terumo Medical Corp.. Cleared Jun 1988. https://www.510kdatabase.net/k881798/ 1988-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k881798-technicon-chem-1r-system-direct-fda-510k.jpg K881798 - TECHNICON CHEM 1(R) SYSTEM, DIRECT BILIRUBIN K881798 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Jun 1988. https://www.510kdatabase.net/k881995/ 1988-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k881995-diamonds-medium-modified-fda-510k.jpg K881995 - DIAMOND'S MEDIUM MODIFIED K881995 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Jun 1988. https://www.510kdatabase.net/k873214/ 1988-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k873214-apx-cardio-echocardiography-system-h4300-fda-510k.jpg K873214 - APX CARDIO ECHOCARDIOGRAPHY SYSTEM #H4300 K873214 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: General Electric Co.. Cleared Jun 1988. https://www.510kdatabase.net/k874138/ 1988-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k874138-accucom-2-fda-510k.jpg K874138 - ACCUCOM 2 K874138 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Jun 1988. https://www.510kdatabase.net/k880988/ 1988-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k880988-pudendallocal-anestesia-block-tray-fda-510k.jpg K880988 - PUDENDAL/LOCAL ANESTESIA BLOCK TRAY K880988 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jun 1988. https://www.510kdatabase.net/k881185/ 1988-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k881185-annular-array-probes-for-artis-3200-fda-510k.jpg K881185 - ANNULAR ARRAY PROBES FOR ARTIS 3200 DIAG. ULTRA. K881185 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Jun 1988. https://www.510kdatabase.net/k881474/ 1988-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k881474-visionr-ldh-lactate-dehydrogenase-fda-510k.jpg K881474 - VISION(R) LDH (LACTATE DEHYDROGENASE) K881474 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1988. https://www.510kdatabase.net/k881495/ 1988-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k881495-synchron-cxtm5-clinical-analyzer-fda-510k.jpg K881495 - SYNCHRON CX(TM)5 CLINICAL ANALYZER K881495 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jun 1988. https://www.510kdatabase.net/k881498/ 1988-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k881498-synchron-cxtm4-clinical-analyzer-fda-510k.jpg K881498 - SYNCHRON CX(TM)4 CLINICAL ANALYZER K881498 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jun 1988. https://www.510kdatabase.net/k881607/ 1988-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k881607-easy-test-emitr-ethosuximide-eths-item-fda-510k.jpg K881607 - EASY-TEST EMIT(R) ETHOSUXIMIDE (ETHS) ITEM 16647 K881607 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jun 1988. https://www.510kdatabase.net/k881809/ 1988-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k881809-rep-lipo-kit-cat-no-3180-fda-510k.jpg K881809 - REP LIPO KIT CAT. NO 3180 K881809 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Jun 1988. https://www.510kdatabase.net/k880401/ 1988-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k880401-denver-peritoneo-venous-shunt-fda-510k.jpg K880401 - DENVER PERITONEO-VENOUS SHUNT K880401 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared May 1988. https://www.510kdatabase.net/k881072/ 1988-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k881072-shiley-femoral-arterial-cannula-fda-510k.jpg K881072 - SHILEY FEMORAL ARTERIAL CANNULA K881072 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared May 1988. https://www.510kdatabase.net/k881074/ 1988-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k881074-shiley-femoral-venous-cannula-fda-510k.jpg K881074 - SHILEY FEMORAL VENOUS CANNULA K881074 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared May 1988. https://www.510kdatabase.net/k881265/ 1988-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k881265-raney-clips-fda-510k.jpg K881265 - RANEY CLIPS K881265 is a FDA 510(k) cleared neurology medical device. Manufacturer: Zimmer, Inc.. Cleared May 1988. https://www.510kdatabase.net/k882019/ 1988-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k882019-sms-90-15-rf-table-and-sms-14-spot-fda-510k.jpg K882019 - SMS 90-15 R&F TABLE AND SMS 14 SPOT FILM DEVICE K882019 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared May 1988. https://www.510kdatabase.net/k875029/ 1988-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k875029-abbott-breath-acetone-analyzer-fda-510k.jpg K875029 - ABBOTT BREATH ACETONE ANALYZER K875029 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared May 1988. https://www.510kdatabase.net/k881229/ 1988-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k881229-auto-troltm-control-levels-1-2-16692-fda-510k.jpg K881229 - AUTO TROL(TM) CONTROL, LEVELS 1 & 2 #16692 & 16693 K881229 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared May 1988. https://www.510kdatabase.net/k881258/ 1988-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k881258-paramax-alcohol-and-ammonia-calibrator-fda-510k.jpg K881258 - PARAMAX ALCOHOL AND AMMONIA CALIBRATOR, I & II K881258 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Baxter Healthcare Corp. Cleared May 1988. https://www.510kdatabase.net/k881337/ 1988-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k881337-emds-lidocaine-calibrator-item-no-fda-510k.jpg K881337 - EMDS LIDOCAINE CALIBRATOR ITEM NO. 67XXX/95 K881337 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared May 1988. https://www.510kdatabase.net/k881357/ 1988-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k881357-emit-convenience-pack-thyroxine-assay-fda-510k.jpg K881357 - EMIT CONVENIENCE PACK: THYROXINE ASSAY K881357 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared May 1988. https://www.510kdatabase.net/k881440/ 1988-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k881440-iq-potassium-fda-510k.jpg K881440 - IQ POTASSIUM K881440 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared May 1988. https://www.510kdatabase.net/k880102/ 1988-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k880102-biasol-concentrates-for-bicarbonate-fda-510k.jpg K880102 - BIASOL CONCENTRATES FOR BICARBONATE DIALYSIS K880102 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared May 1988. https://www.510kdatabase.net/k880605/ 1988-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k880605-labeling-change-for-cutter-pureflo-fda-510k.jpg K880605 - LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER K880605 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Miles Laboratories, Inc.. Cleared May 1988. https://www.510kdatabase.net/k881052/ 1988-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k881052-check-valve-fda-510k.jpg K881052 - CHECK VALVE K881052 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared May 1988. https://www.510kdatabase.net/k874465/ 1988-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k874465-sorenson-thermo-flow-direct-trans-pace-fda-510k.jpg K874465 - SORENSON THERMO. FLOW-DIRECT TRANS PACE CATH/LEAD K874465 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Laboratories. Cleared May 1988. https://www.510kdatabase.net/k875178/ 1988-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k875178-model-435-04-cardifix-side-hook-fda-510k.jpg K875178 - MODEL 435-04 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD K875178 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared May 1988. https://www.510kdatabase.net/k880991/ 1988-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k880991-laser-optical-catheter-system-fda-510k.jpg K880991 - LASER OPTICAL CATHETER SYSTEM K880991 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Medline Industries, Inc.. Cleared May 1988. https://www.510kdatabase.net/k881491/ 1988-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k881491-model-3487a-pisces-epidural-lead-fda-510k.jpg K881491 - MODEL 3487A PISCES EPIDURAL LEAD K881491 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared May 1988. https://www.510kdatabase.net/k881712/ 1988-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k881712-medtronic-model-5866-36-lead-adaptor-kit-fda-510k.jpg K881712 - MEDTRONIC MODEL 5866-36 LEAD ADAPTOR KIT K881712 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared May 1988. https://www.510kdatabase.net/k881882/ 1988-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k881882-senographe-600t-and-600ts-senix-hf-fda-510k.jpg K881882 - SENOGRAPHE 600T AND 600TS SENIX HF K881882 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared May 1988. https://www.510kdatabase.net/k875100/ 1988-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k875100-model-438-03-cardifix-side-hook-fda-510k.jpg K875100 - MODEL 438-03 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD K875100 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared May 1988. https://www.510kdatabase.net/k881006/ 1988-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k881006-stockert-shiley-bubble-monitor-23-23-01-fda-510k.jpg K881006 - STOCKERT-SHILEY BUBBLE MONITOR 23-23-01 K881006 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared May 1988. https://www.510kdatabase.net/k880469/ 1988-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k880469-chlamydiazymetm-fda-510k.jpg K880469 - CHLAMYDIAZYME(TM) K880469 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared May 1988. https://www.510kdatabase.net/k880167/ 1988-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k880167-gore-tex-vascular-graft-fda-510k.jpg K880167 - GORE-TEX VASCULAR GRAFT K880167 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared May 1988. https://www.510kdatabase.net/k880774/ 1988-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k880774-spectrum-fda-510k.jpg K880774 - SPECTRUM K880774 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared May 1988. https://www.510kdatabase.net/k881136/ 1988-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881136-hewlett-packard-models-78354a-78352a-fda-510k.jpg K881136 - HEWLETT-PACKARD MODELS 78354A & 78352A PULSE OXI. K881136 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared May 1988. https://www.510kdatabase.net/k881279/ 1988-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881279-edwards-duromedics-bileaflet-valve-fda-510k.jpg K881279 - EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET K881279 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared May 1988. https://www.510kdatabase.net/k881732/ 1988-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881732-gore-tex-vascular-graft-fda-510k.jpg K881732 - GORE-TEX VASCULAR GRAFT K881732 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared May 1988. https://www.510kdatabase.net/k872881/ 1988-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k872881-abbott-cmv-m-eia-kit-fda-510k.jpg K872881 - ABBOTT CMV-M EIA KIT K872881 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared May 1988. https://www.510kdatabase.net/k875251/ 1988-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k875251-artis-3200-diagnostic-ultrasound-device-fda-510k.jpg K875251 - ARTIS 3200 DIAGNOSTIC ULTRASOUND DEVICE K875251 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared May 1988. https://www.510kdatabase.net/k880663/ 1988-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k880663-shiley-bcd-plus-heat-exchanger-fda-510k.jpg K880663 - SHILEY BCD PLUS HEAT EXCHANGER K880663 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared May 1988. https://www.510kdatabase.net/k881345/ 1988-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k881345-imx-ferritin-fda-510k.jpg K881345 - IMX FERRITIN K881345 is a FDA 510(k) cleared immunology medical device. Manufacturer: Abbott Laboratories. Cleared May 1988. https://www.510kdatabase.net/k881618/ 1988-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k881618-aseptex-1809-fluid-resistant-molded-fda-510k.jpg K881618 - ASEPTEX 1809 FLUID-RESISTANT MOLDED SURGICAL MASK K881618 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared May 1988. https://www.510kdatabase.net/k874127/ 1988-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k874127-abbott-testpack-rsv-fda-510k.jpg K874127 - ABBOTT TESTPACK RSV K874127 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared May 1988. https://www.510kdatabase.net/k880269/ 1988-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k880269-lcs-femoral-hip-prosthesis-fda-510k.jpg K880269 - LCS FEMORAL HIP PROSTHESIS K880269 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared May 1988. https://www.510kdatabase.net/k880644/ 1988-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k880644-ultra-pan-for-orthotic-plastics-7262-fda-510k.jpg K880644 - ULTRA-PAN FOR ORTHOTIC PLASTICS (7262) K880644 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared May 1988. https://www.510kdatabase.net/k880698/ 1988-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k880698-titan-gel-pc-glyco-hemetm-system-fda-510k.jpg K880698 - TITAN GEL-PC GLYCO-HEME(TM) SYSTEM K880698 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared May 1988. https://www.510kdatabase.net/k880821/ 1988-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k880821-resubmitted-abbott-testpack-rotavirus-fda-510k.jpg K880821 - RESUBMITTED ABBOTT TESTPACK ROTAVIRUS K880821 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared May 1988. https://www.510kdatabase.net/k880903/ 1988-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k880903-bard-r-eska-erectiometer-fda-510k.jpg K880903 - BARD (R) ESKA ERECTIOMETER K880903 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 1988. https://www.510kdatabase.net/k881421/ 1988-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k881421-dideco-shiley-feed-tube-support-arms-fda-510k.jpg K881421 - DIDECO-SHILEY FEED TUBE SUPPORT ARMS AND HOOK K881421 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shiley, Inc.. Cleared May 1988. https://www.510kdatabase.net/k880542/ 1988-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k880542-dentalvision-tv-system-fda-510k.jpg K880542 - DENTALVISION TV SYSTEM K880542 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared May 1988. https://www.510kdatabase.net/k874909/ 1988-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k874909-micro-bumintest-reagent-tablets-fda-510k.jpg K874909 - MICRO-BUMINTEST REAGENT TABLETS K874909 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881104/ 1988-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k881104-paramax-iron-reagent-fda-510k.jpg K881104 - PARAMAX IRON REAGENT K881104 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Baxter Healthcare Corp. Cleared Apr 1988. https://www.510kdatabase.net/k880209/ 1988-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k880209-periodontal-probe-autoprobe-fda-510k.jpg K880209 - PERIODONTAL PROBE - AUTOPROBE K880209 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Apr 1988. https://www.510kdatabase.net/k880700/ 1988-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k880700-enzygnostr-tat-reagents-fda-510k.jpg K880700 - ENZYGNOST(R) TAT REAGENTS K880700 is a FDA 510(k) cleared hematology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881290/ 1988-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k881290-modified-shiley-dual-lumen-subclavian-fda-510k.jpg K881290 - MODIFIED SHILEY DUAL LUMEN SUBCLAVIAN CANNULA K881290 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Shiley, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881332/ 1988-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k881332-diaflex-grasp-forcepsretrieval-loop-fda-510k.jpg K881332 - DIAFLEX GRASP FORCEPS/RETRIEVAL LOOP & CYTO BRUSH K881332 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Apr 1988. https://www.510kdatabase.net/k880217/ 1988-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k880217-ssd-870-cardio-vascular-phased-array-fda-510k.jpg K880217 - SSD-870 CARDIO VASCULAR PHASED ARRAY SECTOR SCANN. K880217 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Apr 1988. https://www.510kdatabase.net/k881141/ 1988-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k881141-pharmaseal-isoflex-anesthesia-fda-510k.jpg K881141 - PHARMASEAL ISOFLEX ANESTHESIA BREATHING CIRCUIT K881141 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Apr 1988. https://www.510kdatabase.net/k874770/ 1988-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k874770-tdx-r-amphetamine-class-fda-510k.jpg K874770 - TDX (R) AMPHETAMINE CLASS K874770 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1988. https://www.510kdatabase.net/k875244/ 1988-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k875244-alleia-tm-allergen-specific-ige-system-fda-510k.jpg K875244 - ALLEIA (TM) ALLERGEN SPECIFIC IGE SYSTEM K875244 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Apr 1988. https://www.510kdatabase.net/k880038/ 1988-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k880038-for-the-deter-of-hemoglobin-in-plasma-fda-510k.jpg K880038 - FOR THE DETER. OF HEMOGLOBIN IN PLASMA #527 K880038 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k880160/ 1988-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k880160-dpcs-allergen-specific-ige-system-fda-510k.jpg K880160 - DPC'S ALLERGEN-SPECIFIC IGE SYSTEM K880160 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Apr 1988. https://www.510kdatabase.net/k880653/ 1988-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k880653-hbf-diluent-fda-510k.jpg K880653 - HBF DILUENT K880653 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Apr 1988. https://www.510kdatabase.net/k880897/ 1988-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k880897-nova-gel-tm-scl-70-fda-510k.jpg K880897 - NOVA GEL (TM) SCL-70 K880897 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k880970/ 1988-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k880970-axillary-block-needle-fda-510k.jpg K880970 - AXILLARY BLOCK NEEDLE K880970 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1988. https://www.510kdatabase.net/k881106/ 1988-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k881106-acid-fast-bacilli-histology-control-fda-510k.jpg K881106 - ACID FAST BACILLI HISTOLOGY CONTROL SLIDES K881106 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881109/ 1988-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k881109-spirochetes-histology-control-slides-fda-510k.jpg K881109 - SPIROCHETES HISTOLOGY CONTROL SLIDES K881109 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881112/ 1988-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k881112-fungi-histology-control-slides-fda-510k.jpg K881112 - FUNGI HISTOLOGY CONTROL SLIDES K881112 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881138/ 1988-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k881138-clinical-assays-gammacoat-125i-fda-510k.jpg K881138 - CLINICAL ASSAYS GAMMACOAT [125I] FERRITIN IMMUNO. K881138 is a FDA 510(k) cleared immunology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Apr 1988. https://www.510kdatabase.net/k881339/ 1988-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k881339-nova-litetm-ana-plus-fda-510k.jpg K881339 - NOVA LITE(TM) ANA PLUS K881339 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881457/ 1988-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k881457-kodak-surecell-strep-a-test-kit-fda-510k.jpg K881457 - KODAK SURECELL STREP A TEST KIT K881457 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Eastman Kodak Company. Cleared Apr 1988. https://www.510kdatabase.net/k880290/ 1988-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k880290-microtrak-cmv-culture-confirmation-test-fda-510k.jpg K880290 - MICROTRAK CMV CULTURE CONFIRMATION TEST K880290 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Syva Co.. Cleared Apr 1988. https://www.510kdatabase.net/k880625/ 1988-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k880625-half-hour-infusor-fda-510k.jpg K880625 - HALF HOUR INFUSOR K880625 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Apr 1988. https://www.510kdatabase.net/k881040/ 1988-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k881040-emit-vancomycin-assay-fda-510k.jpg K881040 - EMIT VANCOMYCIN ASSAY K881040 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Apr 1988. https://www.510kdatabase.net/k880087/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k880087-abbott-imx-t3-fda-510k.jpg K880087 - ABBOTT IMX T3 K880087 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1988. https://www.510kdatabase.net/k880619/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k880619-emit-t-uptake-assay-thyroid-hormone-fda-510k.jpg K880619 - EMIT T-UPTAKE ASSAY THYROID HORMONE BINDING RATIO K880619 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Apr 1988. https://www.510kdatabase.net/k881486/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881486-dnase-test-agar-fda-510k.jpg K881486 - DNASE TEST AGAR K881486 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881522/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881522-dextrose-agar-fda-510k.jpg K881522 - DEXTROSE AGAR K881522 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881523/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881523-dextrose-tryptone-broth-fda-510k.jpg K881523 - DEXTROSE TRYPTONE BROTH K881523 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881524/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881524-dermatophyte-test-medium-fda-510k.jpg K881524 - DERMATOPHYTE TEST MEDIUM K881524 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881525/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881525-cooked-meat-medium-fda-510k.jpg K881525 - COOKED MEAT MEDIUM K881525 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881526/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881526-chapman-stone-medium-fda-510k.jpg K881526 - CHAPMAN STONE MEDIUM K881526 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881527/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881527-casman-medium-base-fda-510k.jpg K881527 - CASMAN MEDIUM BASE K881527 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881528/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881528-casein-peptone-low-vitamin-fda-510k.jpg K881528 - CASEIN PEPTONE, LOW VITAMIN K881528 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881529/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881529-cary-and-blair-transport-medium-fda-510k.jpg K881529 - CARY AND BLAIR TRANSPORT MEDIUM K881529 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881530/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881530-brilliant-green-agar-wsulfadiazine-fda-510k.jpg K881530 - BRILLIANT GREEN AGAR W/SULFADIAZINE K881530 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881531/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881531-blood-agar-base-improved-fda-510k.jpg K881531 - BLOOD AGAR BASE, IMPROVED K881531 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881532/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881532-blood-agar-base-wlow-ph-fda-510k.jpg K881532 - BLOOD AGAR BASE W/LOW PH K881532 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881533/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881533-blood-agar-base-no-2-fda-510k.jpg K881533 - BLOOD AGAR BASE NO. 2 K881533 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881534/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881534-antibiotic-medium-9-polymyxin-base-agar-fda-510k.jpg K881534 - ANTIBIOTIC MEDIUM #9 POLYMYXIN BASE AGAR K881534 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881535/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881535-antibiotic-medium-6-fda-510k.jpg K881535 - ANTIBIOTIC MEDIUM #6 K881535 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881536/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881536-antibiotic-medium-5-streptomycin-assay-fda-510k.jpg K881536 - ANTIBIOTIC MEDIUM #5 STREPTOMYCIN ASSAY AGAR K881536 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881537/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881537-antibiotic-medium-19-fda-510k.jpg K881537 - ANTIBIOTIC MEDIUM #19 K881537 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881538/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881538-antibiotic-medium-10-polymyxin-seed-agar-fda-510k.jpg K881538 - ANTIBIOTIC MEDIUM #10 POLYMYXIN SEED AGAR K881538 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881539/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881539-amies-transport-medium-fda-510k.jpg K881539 - AMIES TRANSPORT MEDIUM K881539 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881540/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881540-flo-agar-fda-510k.jpg K881540 - FLO AGAR K881540 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881541/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881541-gelatin-fda-510k.jpg K881541 - GELATIN K881541 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881542/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881542-heart-infusion-agar-fda-510k.jpg K881542 - HEART INFUSION AGAR K881542 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881543/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881543-letheen-agar-fda-510k.jpg K881543 - LETHEEN AGAR K881543 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881544/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881544-littman-agar-fda-510k.jpg K881544 - LITTMAN AGAR K881544 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881545/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881545-malt-extract-fda-510k.jpg K881545 - MALT EXTRACT K881545 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881546/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881546-malt-extract-agar-fda-510k.jpg K881546 - MALT EXTRACT AGAR K881546 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881547/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881547-mitis-salivarius-agar-fda-510k.jpg K881547 - MITIS SALIVARIUS AGAR K881547 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881548/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881548-mph-agar-fda-510k.jpg K881548 - MPH AGAR K881548 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881549/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881549-mycological-agar-wlow-ph-fda-510k.jpg K881549 - MYCOLOGICAL AGAR W/LOW PH K881549 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881550/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881550-of-basal-medium-fda-510k.jpg K881550 - OF BASAL MEDIUM K881550 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881551/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881551-phenol-red-broth-base-fda-510k.jpg K881551 - PHENOL RED BROTH BASE K881551 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881552/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881552-proteose-no-3-agar-fda-510k.jpg K881552 - PROTEOSE NO. 3 AGAR K881552 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881553/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881553-russell-double-sugar-agar-fda-510k.jpg K881553 - RUSSELL DOUBLE SUGAR AGAR K881553 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881554/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881554-skim-milk-dehydrated-fda-510k.jpg K881554 - SKIM MILK DEHYDRATED K881554 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881555/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881555-tinsdale-agar-base-fda-510k.jpg K881555 - TINSDALE AGAR BASE K881555 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881556/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881556-trichomonas-broth-fda-510k.jpg K881556 - TRICHOMONAS BROTH K881556 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881557/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881557-tryptone-fda-510k.jpg K881557 - TRYPTONE K881557 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881558/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881558-tryptose-agar-fda-510k.jpg K881558 - TRYPTOSE AGAR K881558 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881559/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881559-urea-agar-base-fda-510k.jpg K881559 - UREA AGAR BASE K881559 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881560/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881560-urea-broth-fda-510k.jpg K881560 - UREA BROTH K881560 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881561/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881561-tergitol-7-broth-fda-510k.jpg K881561 - TERGITOL 7 BROTH K881561 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881562/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881562-tryptose-blood-agar-base-fda-510k.jpg K881562 - TRYPTOSE BLOOD AGAR BASE K881562 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881563/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881563-tryptose-phosphate-broth-fda-510k.jpg K881563 - TRYPTOSE PHOSPHATE BROTH K881563 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881564/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881564-tryptose-blood-agar-base-wyeast-extract-fda-510k.jpg K881564 - TRYPTOSE BLOOD AGAR BASE W/YEAST EXTRACT K881564 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881565/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881565-inhibitory-mold-agar-fda-510k.jpg K881565 - INHIBITORY MOLD AGAR K881565 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881566/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881566-hemoglobin-powder-fda-510k.jpg K881566 - HEMOGLOBIN POWDER K881566 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881567/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881567-wilkens-chalgren-agar-fda-510k.jpg K881567 - WILKENS CHALGREN AGAR K881567 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881568/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881568-wilkens-chalgren-broth-fda-510k.jpg K881568 - WILKENS CHALGREN BROTH K881568 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881569/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881569-stuarts-transport-medium-fda-510k.jpg K881569 - STUARTS TRANSPORT MEDIUM K881569 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881570/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881570-sabouraud-maltose-agar-fda-510k.jpg K881570 - SABOURAUD MALTOSE AGAR K881570 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881571/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881571-ym-broth-fda-510k.jpg K881571 - YM BROTH K881571 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881572/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881572-xl-agar-base-fda-510k.jpg K881572 - XL AGAR BASE K881572 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881573/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881573-phytone-yeast-extract-agar-fda-510k.jpg K881573 - PHYTONE YEAST EXTRACT AGAR K881573 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881574/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881574-w-l-differential-medium-fda-510k.jpg K881574 - W-L DIFFERENTIAL MEDIUM K881574 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881575/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881575-selective-streptococcus-agar-fda-510k.jpg K881575 - SELECTIVE STREPTOCOCCUS AGAR K881575 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881576/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881576-selenite-broth-fda-510k.jpg K881576 - SELENITE BROTH K881576 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881577/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881577-modified-selective-streptococcus-agar-fda-510k.jpg K881577 - MODIFIED SELECTIVE STREPTOCOCCUS AGAR K881577 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881578/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881578-streptosel-fda-510k.jpg K881578 - STREPTOSEL K881578 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881579/ 1988-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k881579-amies-transport-medium-wo-charcoal-fda-510k.jpg K881579 - AMIES TRANSPORT MEDIUM W/O CHARCOAL K881579 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881014/ 1988-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k881014-the-karl-storz-mini-9000-solid-state-fda-510k.jpg K881014 - THE KARL STORZ MINI 9000 SOLID STATE CCD VIDEO CAM K881014 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k875364/ 1988-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k875364-modified-pca-infuser-fda-510k.jpg K875364 - MODIFIED PCA INFUSER K875364 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1988. https://www.510kdatabase.net/k880430/ 1988-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k880430-gram-negative-miccombo-panels-fda-510k.jpg K880430 - GRAM NEGATIVE MIC/COMBO PANELS K880430 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Apr 1988. https://www.510kdatabase.net/k881108/ 1988-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k881108-pneumocystis-carinii-histology-control-fda-510k.jpg K881108 - PNEUMOCYSTIS CARINII HISTOLOGY CONTROL SLIDES K881108 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881110/ 1988-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k881110-legionella-pneumophilla-histology-fda-510k.jpg K881110 - LEGIONELLA PNEUMOPHILLA HISTOLOGY CONTROL SLIDES K881110 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881248/ 1988-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k881248-kodak-automatic-film-feeder-model-11-fda-510k.jpg K881248 - KODAK AUTOMATIC FILM FEEDER, MODEL 11 K881248 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Apr 1988. https://www.510kdatabase.net/k880637/ 1988-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k880637-baxter-pharmaseal-patient-gas-sampling-fda-510k.jpg K880637 - BAXTER, PHARMASEAL PATIENT GAS SAMPLING LINES K880637 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Apr 1988. https://www.510kdatabase.net/k880356/ 1988-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k880356-n-protein-standard-plasma-human-fda-510k.jpg K880356 - N PROTEIN STANDARD PLASMA (HUMAN) K880356 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k881181/ 1988-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k881181-nova-geltm-smrnp-fda-510k.jpg K881181 - NOVA GEL(TM) SM/RNP K881181 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k875079/ 1988-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k875079-modified-seralyzer-altsgpt-reag-strips-fda-510k.jpg K875079 - MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE K875079 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k875135/ 1988-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k875135-emit-700-cannabinoid-100-ng-calibrator-fda-510k.jpg K875135 - EMIT 700 CANNABINOID 100 NG CALIBRATOR & CONTROL K875135 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Apr 1988. https://www.510kdatabase.net/k880086/ 1988-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k880086-abbott-imx-htsh-fda-510k.jpg K880086 - ABBOTT IMX HTSH K880086 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1988. https://www.510kdatabase.net/k880445/ 1988-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k880445-lyphochek-urine-toxicology-control-low-fda-510k.jpg K880445 - LYPHOCHEK URINE TOXICOLOGY CONTROL - LOW K880445 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bio-Rad. Cleared Apr 1988. https://www.510kdatabase.net/k880743/ 1988-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k880743-abbott-a-gent-neonatal-bilirubin-reagent-fda-510k.jpg K880743 - ABBOTT A-GENT NEONATAL BILIRUBIN REAGENT K880743 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1988. https://www.510kdatabase.net/k872298/ 1988-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k872298-tegasorb-ulcer-dressing-90-xxx-fda-510k.jpg K872298 - TEGASORB ULCER DRESSING #90-XXX K872298 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3M Company. Cleared Apr 1988. https://www.510kdatabase.net/k880052/ 1988-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k880052-edwards-duromedics-mitral-valve-rotator-fda-510k.jpg K880052 - EDWARDS-DUROMEDICS MITRAL VALVE ROTATOR K880052 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Baxter Healthcare Corp. Cleared Apr 1988. https://www.510kdatabase.net/k880647/ 1988-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k880647-adult-perceptual-motor-puzzles-5331-01-fda-510k.jpg K880647 - ADULT PERCEPTUAL MOTOR PUZZLES (5331-01) K880647 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Fred Sammons, Inc.. Cleared Apr 1988. https://www.510kdatabase.net/k880950/ 1988-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k880950-pyresculin-disk-fda-510k.jpg K880950 - PYR/ESCULIN DISK K880950 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Apr 1988. https://www.510kdatabase.net/k872024/ 1988-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k872024-co202-monitor-multinex-fda-510k.jpg K872024 - CO2/02 MONITOR MULTINEX K872024 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Datascope Corp.. Cleared Mar 1988. https://www.510kdatabase.net/k880596/ 1988-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k880596-eosin-y-solution-alcoholic-with-phloxine-fda-510k.jpg K880596 - EOSIN Y SOLUTION, ALCOHOLIC, WITH PHLOXINE K880596 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Mar 1988. https://www.510kdatabase.net/k880691/ 1988-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k880691-earles-balanced-salts-wout-phenol-red-fda-510k.jpg K880691 - EARLE'S BALANCED SALTS W/OUT PHENOL RED & SODIUM K880691 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Mar 1988. https://www.510kdatabase.net/k881107/ 1988-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k881107-intracellular-amyloid-histology-fda-510k.jpg K881107 - INTRACELLULAR AMYLOID HISTOLOGY CONTROL SLIDES K881107 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Mar 1988. https://www.510kdatabase.net/k881111/ 1988-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k881111-intracellularextracellular-iron-fda-510k.jpg K881111 - INTRACELLULAR/EXTRACELLULAR IRON HISTOLOGY CONTROL K881111 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Mar 1988. https://www.510kdatabase.net/k880965/ 1988-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k880965-somatom-plus-fda-510k.jpg K880965 - SOMATOM PLUS K880965 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 1988. https://www.510kdatabase.net/k881222/ 1988-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k881222-johnson-johnson-fluff-sponge-fda-510k.jpg K881222 - JOHNSON & JOHNSON FLUFF SPONGE K881222 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Mar 1988. https://www.510kdatabase.net/k880718/ 1988-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k880718-calcofluor-white-stain-kit-fda-510k.jpg K880718 - CALCOFLUOR WHITE STAIN KIT K880718 is a FDA 510(k) cleared pathology medical device. Manufacturer: Remel Co.. Cleared Mar 1988. https://www.510kdatabase.net/k880736/ 1988-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k880736-nova-litetm-ana-fda-510k.jpg K880736 - NOVA LITE(TM) ANA K880736 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Mar 1988. https://www.510kdatabase.net/k880742/ 1988-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k880742-nova-litetm-dsdna-fda-510k.jpg K880742 - NOVA LITE(TM) DSDNA K880742 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Mar 1988. https://www.510kdatabase.net/k880896/ 1988-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k880896-nova-geltm-ss-ass-b-fda-510k.jpg K880896 - NOVA GEL(TM) SS-A/SS-B K880896 is a FDA 510(k) cleared immunology medical device. Manufacturer: Inova Diagnostics, Inc.. Cleared Mar 1988. https://www.510kdatabase.net/k880070/ 1988-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k880070-abbott-imx-hcg-fda-510k.jpg K880070 - ABBOTT IMX HCG K880070 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1988. https://www.510kdatabase.net/k880546/ 1988-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k880546-total-iron-binding-capacity-tibc-fda-510k.jpg K880546 - TOTAL IRON BINDING CAPACITY (TIBC) K880546 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Mar 1988. https://www.510kdatabase.net/k880610/ 1988-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k880610-unimeter-calibration-kit-fda-510k.jpg K880610 - UNIMETER CALIBRATION KIT K880610 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Mar 1988. https://www.510kdatabase.net/k880620/ 1988-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k880620-emit-thyroxine-assay-fda-510k.jpg K880620 - EMIT THYROXINE ASSAY K880620 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Mar 1988. https://www.510kdatabase.net/k880651/ 1988-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k880651-paramax-ammonia-reagent-fda-510k.jpg K880651 - PARAMAX AMMONIA REAGENT K880651 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 1988. https://www.510kdatabase.net/k881115/ 1988-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k881115-bactecr-nr26-and-bactecr-nr-27-culture-fda-510k.jpg K881115 - BACTEC(R) NR26 AND BACTEC(R) NR 27 CULTURE MEDIA K881115 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1988. https://www.510kdatabase.net/k872126/ 1988-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k872126-model-438-02-cardifix-side-hook-fda-510k.jpg K872126 - MODEL 438-02 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD K872126 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Mar 1988. https://www.510kdatabase.net/k873403/ 1988-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k873403-cordis-steerable-guidewire-fda-510k.jpg K873403 - CORDIS STEERABLE GUIDEWIRE K873403 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Mar 1988. https://www.510kdatabase.net/k880323/ 1988-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k880323-medtronic-model-5411-surgical-cable-fda-510k.jpg K880323 - MEDTRONIC MODEL 5411 SURGICAL CABLE ADAPTOR K880323 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Mar 1988. https://www.510kdatabase.net/k875345/ 1988-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k875345-visionr-crp-fda-510k.jpg K875345 - VISION(R) CRP K875345 is a FDA 510(k) cleared immunology medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1988. https://www.510kdatabase.net/k880563/ 1988-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k880563-3m-xp515-x-ray-film-processor-fda-510k.jpg K880563 - 3M XP515 X-RAY FILM PROCESSOR K880563 is a FDA 510(k) cleared radiology medical device. Manufacturer: 3M Company. Cleared Mar 1988. https://www.510kdatabase.net/k880564/ 1988-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k880564-3m-xp-505-x-ray-film-processor-fda-510k.jpg K880564 - 3M XP 505 X-RAY FILM PROCESSOR K880564 is a FDA 510(k) cleared radiology medical device. Manufacturer: 3M Company. Cleared Mar 1988. https://www.510kdatabase.net/k880565/ 1988-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k880565-3m-trimatic-m-modular-system-and-fda-510k.jpg K880565 - 3M TRIMATIC M MODULAR SYSTEM AND ACCESSORIES K880565 is a FDA 510(k) cleared radiology medical device. Manufacturer: 3M Company. Cleared Mar 1988. https://www.510kdatabase.net/k880636/ 1988-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k880636-reticcount-software-fda-510k.jpg K880636 - RETICCOUNT SOFTWARE K880636 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1988. https://www.510kdatabase.net/k881048/ 1988-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k881048-airstrip-waterproof-first-aid-fda-510k.jpg K881048 - AIRSTRIP* WATERPROOF FIRST AID DRESS/POST-OPERA. K881048 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Mar 1988. https://www.510kdatabase.net/k881128/ 1988-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k881128-titanium-femoral-hip-fda-510k.jpg K881128 - TITANIUM FEMORAL HIP K881128 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Mar 1988. https://www.510kdatabase.net/k880482/ 1988-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k880482-secondary-solution-administration-set-fda-510k.jpg K880482 - SECONDARY SOLUTION ADMINISTRATION SET W/SHEATH K880482 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 1988. https://www.510kdatabase.net/k880874/ 1988-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k880874-immunoadsorbed-factor-vii-deficient-fda-510k.jpg K880874 - IMMUNOADSORBED FACTOR VII DEFICIENT PLASMA HUMAN K880874 is a FDA 510(k) cleared hematology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 1988. https://www.510kdatabase.net/k880315/ 1988-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k880315-dade-antithrombin-iii-chromogenic-assay-fda-510k.jpg K880315 - DADE ANTITHROMBIN III CHROMOGENIC ASSAY K880315 is a FDA 510(k) cleared hematology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 1988. https://www.510kdatabase.net/k880496/ 1988-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k880496-lyphochek-quantitative-urine-control-fda-510k.jpg K880496 - LYPHOCHEK QUANTITATIVE URINE CONTROL NORMAL (1) K880496 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Mar 1988. https://www.510kdatabase.net/k880609/ 1988-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k880609-analyte-carbon-dioxide-assayed-on-fda-510k.jpg K880609 - ANALYTE CARBON DIOXIDE ASSAYED ON TECHNICON RA(TM) K880609 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Mar 1988. https://www.510kdatabase.net/k880662/ 1988-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k880662-visionr-thyroxine-t4-fda-510k.jpg K880662 - VISION(R) THYROXINE (T4) K880662 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1988. https://www.510kdatabase.net/k880268/ 1988-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k880268-co2-reagent-fda-510k.jpg K880268 - CO2 REAGENT K880268 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Mar 1988. https://www.510kdatabase.net/k880495/ 1988-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k880495-lyphochek-quantitative-urine-control-fda-510k.jpg K880495 - LYPHOCHEK QUANTITATIVE URINE CONTROL ABNORMAL (2) K880495 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Mar 1988. https://www.510kdatabase.net/k880826/ 1988-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k880826-microloctm-porous-coated-unicondylar-fda-510k.jpg K880826 - MICROLOC(TM) POROUS COATED UNICONDYLAR KNEE SYSTEM K880826 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Mar 1988. https://www.510kdatabase.net/k880003/ 1988-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k880003-additional-allergens-for-ige-fast-plus-fda-510k.jpg K880003 - ADDITIONAL ALLERGENS FOR IGE FAST-PLUS TEST K880003 is a FDA 510(k) cleared immunology medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Mar 1988. https://www.510kdatabase.net/k880009/ 1988-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k880009-revised-labeling-for-adx-cocaine-fda-510k.jpg K880009 - REVISED LABELING FOR ADX COCAINE METABOLITE K880009 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1988. https://www.510kdatabase.net/k874635/ 1988-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k874635-omnifit-total-knee-bone-augmentation-fda-510k.jpg K874635 - OMNIFIT TOTAL KNEE BONE AUGMENTATION WEDGES K874635 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Mar 1988. https://www.510kdatabase.net/k880082/ 1988-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k880082-memorymate-hearing-aid-model-8200-fda-510k.jpg K880082 - MEMORYMATE HEARING AID MODEL 8200 K880082 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: 3M Company. Cleared Mar 1988. https://www.510kdatabase.net/k880614/ 1988-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k880614-shiley-disp-cannula-cuffless-fda-510k.jpg K880614 - SHILEY DISP. CANNULA CUFFLESS TRACEOSTOMY TUBE K880614 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shiley, Inc.. Cleared Mar 1988. https://www.510kdatabase.net/k880551/ 1988-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k880551-model-439-07-and-439-09-lifeline-fda-510k.jpg K880551 - MODEL 439-07 AND 439-09 LIFELINE MYOCARDIAL LEAD K880551 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Mar 1988. https://www.510kdatabase.net/k874916/ 1988-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k874916-technicon-chem-1tm-system-fda-510k.jpg K874916 - TECHNICON CHEM 1(TM) SYSTEM K874916 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Mar 1988. https://www.510kdatabase.net/k880494/ 1988-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k880494-lyphochek-spinal-fluid-control-human-fda-510k.jpg K880494 - LYPHOCHEK SPINAL FLUID CONTROL (HUMAN) K880494 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Mar 1988. https://www.510kdatabase.net/k880716/ 1988-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k880716-slide-culture-plate-potato-flake-agar-fda-510k.jpg K880716 - SLIDE CULTURE PLATE-POTATO FLAKE AGAR K880716 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Mar 1988. https://www.510kdatabase.net/k880717/ 1988-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k880717-slide-culture-plate-potato-dextrose-agar-fda-510k.jpg K880717 - SLIDE CULTURE PLATE-POTATO DEXTROSE AGAR K880717 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Mar 1988. https://www.510kdatabase.net/k871555/ 1988-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k871555-rt5000-wquanti-spec-doppler-cw-dopp-fda-510k.jpg K871555 - RT5000 W/QUANTI. SPEC. DOPPLER, CW DOPP. MODIFICA. K871555 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: General Electric Co.. Cleared Mar 1988. https://www.510kdatabase.net/k875166/ 1988-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k875166-pharmaseal-sterile-umbilical-cord-clamp-fda-510k.jpg K875166 - PHARMASEAL STERILE UMBILICAL CORD CLAMP K875166 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 1988. https://www.510kdatabase.net/k880402/ 1988-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k880402-codman-surgical-pattie-fda-510k.jpg K880402 - CODMAN SURGICAL PATTIE K880402 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Mar 1988. https://www.510kdatabase.net/k880590/ 1988-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k880590-disposable-dental-probeexplorer-fda-510k.jpg K880590 - DISPOSABLE DENTAL PROBE/EXPLORER K880590 is a FDA 510(k) cleared dental medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 1988. https://www.510kdatabase.net/k880012/ 1988-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k880012-revised-labeling-for-adx-barbiturates-fda-510k.jpg K880012 - REVISED LABELING FOR ADX BARBITURATES K880012 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1988. https://www.510kdatabase.net/k880013/ 1988-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k880013-revised-labeling-for-adx-fda-510k.jpg K880013 - REVISED LABELING FOR ADX AMPHETAMINE/METHAMPHETA. K880013 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1988. https://www.510kdatabase.net/k880015/ 1988-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k880015-revised-labeling-for-adx-cannabinoids-fda-510k.jpg K880015 - REVISED LABELING FOR ADX CANNABINOIDS K880015 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1988. https://www.510kdatabase.net/k880175/ 1988-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k880175-dader-ckld-comprehensive-electro-control-fda-510k.jpg K880175 - DADE(R) CK/LD COMPREHENSIVE ELECTRO. CONTROL K880175 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Baxter Healthcare Corp. Cleared Mar 1988. https://www.510kdatabase.net/k880188/ 1988-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k880188-souter-strathclyde-total-elbow-system-fda-510k.jpg K880188 - SOUTER STRATHCLYDE TOTAL ELBOW SYSTEM K880188 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Mar 1988. https://www.510kdatabase.net/k880344/ 1988-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k880344-iq-alkaline-phosphatase-fda-510k.jpg K880344 - IQ ALKALINE PHOSPHATASE K880344 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1988. https://www.510kdatabase.net/k873100/ 1988-02-29 monthly 0.5 https://www.510kdatabase.net/og-image/k873100-olympus-angioscopy-sheath-fda-510k.jpg K873100 - OLYMPUS ANGIOSCOPY SHEATH K873100 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Olympus Corp.. Cleared Feb 1988. https://www.510kdatabase.net/k875090/ 1988-02-29 monthly 0.5 https://www.510kdatabase.net/og-image/k875090-auto-suture-disposable-approximating-fda-510k.jpg K875090 - AUTO SUTURE DISPOSABLE APPROXIMATING CLAMP* K875090 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Feb 1988. https://www.510kdatabase.net/k880001/ 1988-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k880001-multi-allergen-ige-fast-screen-iii-fda-510k.jpg K880001 - MULTI-ALLERGEN IGE FAST SCREEN III D1,E1,G6,M2,T3 K880001 is a FDA 510(k) cleared immunology medical device. Manufacturer: 3M Company. Cleared Feb 1988. https://www.510kdatabase.net/k880339/ 1988-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k880339-easy-test-potassium-k-item-number-19xxx-fda-510k.jpg K880339 - EASY-TEST POTASSIUM K ITEM NUMBER 19XXX K880339 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Feb 1988. https://www.510kdatabase.net/k880444/ 1988-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k880444-lyphochek-urine-toxicology-control-fda-510k.jpg K880444 - LYPHOCHEK URINE TOXICOLOGY CONTROL - NEGATIVE K880444 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bio-Rad. Cleared Feb 1988. https://www.510kdatabase.net/k875102/ 1988-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k875102-deter-of-hemoglobin-a2-using-the-diamat-fda-510k.jpg K875102 - DETER. OF HEMOGLOBIN A2 USING THE DIAMAT K875102 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bio-Rad. Cleared Feb 1988. https://www.510kdatabase.net/k875173/ 1988-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k875173-kodak-ektachem-dt-slides-lipa-fda-510k.jpg K875173 - KODAK EKTACHEM DT SLIDES (LIPA) K875173 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Feb 1988. https://www.510kdatabase.net/k875191/ 1988-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k875191-kodak-ektachem-dt-slides-crsc-fda-510k.jpg K875191 - KODAK EKTACHEM DT SLIDES (CRSC) K875191 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Feb 1988. https://www.510kdatabase.net/k875192/ 1988-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k875192-kodak-ektachem-dt-slides-ckmb-fda-510k.jpg K875192 - KODAK EKTACHEM DT SLIDES (CKMB) K875192 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Feb 1988. https://www.510kdatabase.net/k880039/ 1988-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k880039-ammonia-controls-low-and-high-a-5565-a-fda-510k.jpg K880039 - AMMONIA CONTROLS LOW AND HIGH #A 5565 & A 6665 K880039 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Feb 1988. https://www.510kdatabase.net/k880650/ 1988-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k880650-heyer-schulter-100cc-400cc-exudate-fda-510k.jpg K880650 - HEYER-SCHULTE(R) 100CC & 400CC EXUDATE DISP. BAGS K880650 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Baxter Healthcare Corp. Cleared Feb 1988. https://www.510kdatabase.net/k875132/ 1988-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k875132-periodontal-scaling-solution-a-fda-510k.jpg K875132 - PERIODONTAL SCALING SOLUTION-A K875132 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Feb 1988. https://www.510kdatabase.net/k875149/ 1988-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k875149-peridontal-scaling-solution-b-fda-510k.jpg K875149 - PERIDONTAL SCALING SOLUTION-B K875149 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Feb 1988. https://www.510kdatabase.net/k875150/ 1988-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k875150-periodontal-scaling-solution-c-fda-510k.jpg K875150 - PERIODONTAL SCALING SOLUTION-C K875150 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Feb 1988. https://www.510kdatabase.net/k874181/ 1988-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k874181-baxter-bedside-system-fda-510k.jpg K874181 - BAXTER BEDSIDE SYSTEM K874181 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Feb 1988. https://www.510kdatabase.net/k880583/ 1988-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k880583-modified-formed-extension-mahurkar-fda-510k.jpg K880583 - MODIFIED FORMED-EXTENSION MAHURKAR DUAL LUMEN CATH K880583 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quinton, Inc.. Cleared Feb 1988. https://www.510kdatabase.net/k874945/ 1988-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k874945-cement-liner-fda-510k.jpg K874945 - CEMENT LINER K874945 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Feb 1988. https://www.510kdatabase.net/k880292/ 1988-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k880292-factor-viii-reference-plasma-fda-510k.jpg K880292 - FACTOR VIII REFERENCE PLASMA K880292 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Feb 1988. https://www.510kdatabase.net/k872632/ 1988-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k872632-du-pont-herpchek-hsv-antigen-elisa-fda-510k.jpg K872632 - DU PONT HERPCHEK HSV ANTIGEN ELISA TEST KIT K872632 is a FDA 510(k) cleared microbiology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Feb 1988. https://www.510kdatabase.net/k873762/ 1988-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k873762-series-77000-ultrasound-imaging-system-fda-510k.jpg K873762 - SERIES 77000 ULTRASOUND IMAGING SYSTEM K873762 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Feb 1988. https://www.510kdatabase.net/k874731/ 1988-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k874731-lyphochek-whole-blood-control-fda-510k.jpg K874731 - LYPHOCHEK WHOLE BLOOD CONTROL K874731 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Feb 1988. https://www.510kdatabase.net/k874763/ 1988-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k874763-cellect-model-d-automated-hemtalogy-fda-510k.jpg K874763 - CELLECT MODEL D, AUTOMATED HEMTALOGY ANALYZER K874763 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Feb 1988. https://www.510kdatabase.net/k874808/ 1988-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k874808-coat-a-count-opiates-screen-tkos1-tkos5-fda-510k.jpg K874808 - COAT-A-COUNT OPIATES SCREEN TKOS1, TKOS5 K874808 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Feb 1988. https://www.510kdatabase.net/k880436/ 1988-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k880436-microtrak-hsv-culture-identification-fda-510k.jpg K880436 - MICROTRAK HSV CULTURE IDENTIFICATION TEST K880436 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Syva Co.. Cleared Feb 1988. https://www.510kdatabase.net/k874633/ 1988-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k874633-permcath-insertion-tray-fda-510k.jpg K874633 - PERMCATH INSERTION TRAY K874633 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quinton, Inc.. Cleared Feb 1988. https://www.510kdatabase.net/k880002/ 1988-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k880002-multi-allergen-ige-fast-screen-molds-fda-510k.jpg K880002 - MULTI-ALLERGEN IGE FAST SCREEN (MOLDS) K880002 is a FDA 510(k) cleared immunology medical device. Manufacturer: 3M Company. Cleared Feb 1988. https://www.510kdatabase.net/k880156/ 1988-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k880156-volz-total-wrist-prosthesis-fda-510k.jpg K880156 - VOLZ TOTAL WRIST PROSTHESIS K880156 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Feb 1988. https://www.510kdatabase.net/k880341/ 1988-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k880341-n-immunoglobulin-light-chain-kit-fda-510k.jpg K880341 - N-IMMUNOGLOBULIN LIGHT CHAIN KIT K880341 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Feb 1988. https://www.510kdatabase.net/k874328/ 1988-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k874328-l-phenylalanine-methyl-ester-fda-510k.jpg K874328 - L-PHENYLALANINE METHYL ESTER HYDROCHLORIDE PME REA K874328 is a FDA 510(k) cleared hematology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Feb 1988. https://www.510kdatabase.net/k874836/ 1988-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k874836-abuscreenr-eia-amphetamine-fda-510k.jpg K874836 - ABUSCREEN(R) EIA AMPHETAMINE K874836 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Feb 1988. https://www.510kdatabase.net/k875105/ 1988-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k875105-technicon-smac-3-system-fda-510k.jpg K875105 - TECHNICON SMAC 3 SYSTEM K875105 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Feb 1988. https://www.510kdatabase.net/k880247/ 1988-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k880247-modified-shiley-low-pressure-cuffed-fda-510k.jpg K880247 - MODIFIED SHILEY LOW PRESSURE CUFFED TRACHEO. TUBES K880247 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shiley, Inc.. Cleared Feb 1988. https://www.510kdatabase.net/k874782/ 1988-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k874782-coat-a-count-neonatal-17-alpha-fda-510k.jpg K874782 - COAT-A-COUNT NEONATAL 17-ALPHA HYDROXPROG RIA KIT K874782 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Feb 1988. https://www.510kdatabase.net/k875062/ 1988-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k875062-easy-test-prothrombin-time-pt-item-no-fda-510k.jpg K875062 - EASY-TEST PROTHROMBIN TIME PT ITEM NO. 16628 K875062 is a FDA 510(k) cleared hematology medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Feb 1988. https://www.510kdatabase.net/k875196/ 1988-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k875196-disposable-coronary-control-syringe-12cc-fda-510k.jpg K875196 - DISPOSABLE CORONARY CONTROL SYRINGE 12CC K875196 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Merit Medical Systems, Inc.. Cleared Feb 1988. https://www.510kdatabase.net/k880010/ 1988-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k880010-revised-labeling-for-adx-opiates-fda-510k.jpg K880010 - REVISED LABELING FOR ADX OPIATES K880010 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Feb 1988. https://www.510kdatabase.net/k880011/ 1988-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k880011-revised-labeling-for-adx-phencyclidine-fda-510k.jpg K880011 - REVISED LABELING FOR ADX PHENCYCLIDINE K880011 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Feb 1988. https://www.510kdatabase.net/k880014/ 1988-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k880014-revisied-labeling-for-adx-fda-510k.jpg K880014 - REVISIED LABELING FOR ADX BENZODIAZEPINES K880014 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Feb 1988. https://www.510kdatabase.net/k874873/ 1988-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k874873-combigenetm-anti-dna-kaddz-kadd1-fda-510k.jpg K874873 - COMBIGENE(TM) ANTI-DNA #KADDZ, KADD1 K874873 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Feb 1988. https://www.510kdatabase.net/k874940/ 1988-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k874940-calibration-reference-plasma-fda-510k.jpg K874940 - CALIBRATION REFERENCE PLASMA K874940 is a FDA 510(k) cleared hematology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Feb 1988. https://www.510kdatabase.net/k875310/ 1988-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k875310-reticulocyte-stain-fda-510k.jpg K875310 - RETICULOCYTE STAIN K875310 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Feb 1988. https://www.510kdatabase.net/k874388/ 1988-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k874388-kodak-surecelltm-hcg-urine-kit-fda-510k.jpg K874388 - KODAK SURECELL(TM) HCG-URINE KIT K874388 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Feb 1988. https://www.510kdatabase.net/k874857/ 1988-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k874857-kodak-ektachem-700-analyzer-family-fda-510k.jpg K874857 - KODAK EKTACHEM 700 ANALYZER FAMILY, SOFTWARE V4.0 K874857 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Feb 1988. https://www.510kdatabase.net/k874944/ 1988-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k874944-modified-prisma-shield-pit-fissure-fda-510k.jpg K874944 - MODIFIED PRISMA SHIELD PIT & FISSURE SEALANT K874944 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Feb 1988. https://www.510kdatabase.net/k875263/ 1988-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k875263-analytes-sodium-potassium-assayed-on-fda-510k.jpg K875263 - ANALYTES SODIUM & POTASSIUM ASSAYED ON TECH RA(R) K875263 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Feb 1988. https://www.510kdatabase.net/k874171/ 1988-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k874171-model-5650c-cardiology-data-management-fda-510k.jpg K874171 - MODEL 5650C CARDIOLOGY DATA MANAGEMENT SYSTEM K874171 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Feb 1988. https://www.510kdatabase.net/k874592/ 1988-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k874592-thromboplastinc-fda-510k.jpg K874592 - THROMBOPLASTIN.C K874592 is a FDA 510(k) cleared hematology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Feb 1988. https://www.510kdatabase.net/k880157/ 1988-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k880157-microtrak-hsv-1hsv-2-culture-fda-510k.jpg K880157 - MICROTRAK HSV 1/HSV 2 CULTURE IDENTI./TYPING TEST K880157 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Syva Co.. Cleared Feb 1988. https://www.510kdatabase.net/k880205/ 1988-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k880205-edwards-orthopaedics-arthroscopes-and-fda-510k.jpg K880205 - EDWARDS ORTHOPAEDICS ARTHROSCOPES AND ACCESSORIES K880205 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Baxter Healthcare Corp. Cleared Feb 1988. https://www.510kdatabase.net/k874775/ 1988-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k874775-electrode-tip-cleaner-fda-510k.jpg K874775 - ELECTRODE TIP CLEANER K874775 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Feb 1988. https://www.510kdatabase.net/k875252/ 1988-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k875252-aca-du-pont-urine-cannabinoids-u-thc-fda-510k.jpg K875252 - ACA DU PONT URINE CANNABINOIDS (U THC) SCREEN METH K875252 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Feb 1988. https://www.510kdatabase.net/k880271/ 1988-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k880271-resubmitted-excalibur-fda-510k.jpg K880271 - RESUBMITTED EXCALIBUR K880271 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Quinton, Inc.. Cleared Feb 1988. https://www.510kdatabase.net/k873962/ 1988-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k873962-medtronic-model-4016a-endocardial-fda-510k.jpg K873962 - MEDTRONIC MODEL 4016A ENDOCARDIAL PACING LEAD K873962 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Feb 1988. https://www.510kdatabase.net/k874757/ 1988-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k874757-stratusr-immunoassay-controls-levels-i-fda-510k.jpg K874757 - STRATUS(R) IMMUNOASSAY CONTROLS LEVELS I, II, III K874757 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Feb 1988. https://www.510kdatabase.net/k874020/ 1988-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k874020-ultracaretm-automated-patient-assist-fda-510k.jpg K874020 - ULTRACARE(TM) AUTOMATED PATIENT ASSIST DEVICE K874020 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Abbott Laboratories. Cleared Jan 1988. https://www.510kdatabase.net/k874728/ 1988-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k874728-capillary-flow-dialyzers-fda-510k.jpg K874728 - CAPILLARY FLOW DIALYZERS K874728 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jan 1988. https://www.510kdatabase.net/k874421/ 1988-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k874421-pre-gelled-disposable-ecg-electrode-fda-510k.jpg K874421 - PRE-GELLED DISPOSABLE ECG ELECTRODE - HP13941A K874421 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Jan 1988. https://www.510kdatabase.net/k874422/ 1988-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k874422-pre-gelled-disposable-clear-tape-ecg-fda-510k.jpg K874422 - PRE-GELLED DISPOSABLE CLEAR TAPE ECG ELEC.HP13942D K874422 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Jan 1988. https://www.510kdatabase.net/k874423/ 1988-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k874423-pre-gelled-disposable-ecg-electrode-fda-510k.jpg K874423 - PRE-GELLED DISPOSABLE ECG ELECTRODE - HP40493E K874423 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Jan 1988. https://www.510kdatabase.net/k874424/ 1988-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k874424-pre-gelled-disposable-ecg-tape-fda-510k.jpg K874424 - PRE-GELLED DISPOSABLE ECG TAPE ELECTRODE HP40489E K874424 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Jan 1988. https://www.510kdatabase.net/k875284/ 1988-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k875284-medtronic-snap-ease-model-7795-fda-510k.jpg K875284 - MEDTRONIC SNAP EASE MODEL 7795 CUTANEOUS ELECTRODE K875284 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Jan 1988. https://www.510kdatabase.net/k874320/ 1988-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k874320-cellect-labtrak-software-fda-510k.jpg K874320 - CELLECT LABTRAK SOFTWARE K874320 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jan 1988. https://www.510kdatabase.net/k874506/ 1988-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k874506-use-of-technicon-ra-systems-reagents-fda-510k.jpg K874506 - USE OF TECHNICON RA SYSTEMS REAGENTS ON ASSIST(R) K874506 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Jan 1988. https://www.510kdatabase.net/k874187/ 1988-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k874187-a-gent-trigllycerides-gpo-fda-510k.jpg K874187 - A-GENT TRIGLLYCERIDES GPO K874187 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jan 1988. https://www.510kdatabase.net/k874280/ 1988-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k874280-lyphochek-assayed-chemistry-control-fda-510k.jpg K874280 - LYPHOCHEK ASSAYED CHEMISTRY CONTROL (HUMAN), I/II K874280 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Jan 1988. https://www.510kdatabase.net/k874438/ 1988-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k874438-stratus-vancomycin-fluorometric-enzyme-fda-510k.jpg K874438 - STRATUS VANCOMYCIN FLUOROMETRIC ENZYME IMMUNOASSAY K874438 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jan 1988. https://www.510kdatabase.net/k874576/ 1988-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k874576-kodak-ektachem-dt-slides-mg-fda-510k.jpg K874576 - KODAK EKTACHEM DT SLIDES (MG) K874576 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Jan 1988. https://www.510kdatabase.net/k874577/ 1988-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k874577-kodak-ektachem-dt-slides-phos-fda-510k.jpg K874577 - KODAK EKTACHEM DT SLIDES (PHOS) K874577 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Jan 1988. https://www.510kdatabase.net/k874586/ 1988-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k874586-easy-test-alanine-aminotransferase-fda-510k.jpg K874586 - EASY-TEST ALANINE AMINOTRANSFERASE (ALAT) #19017 K874586 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jan 1988. https://www.510kdatabase.net/k874600/ 1988-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k874600-easy-test-aspartate-aminotransferase-fda-510k.jpg K874600 - EASY-TEST ASPARTATE AMINOTRANSFERASE (ASAT) #19010 K874600 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jan 1988. https://www.510kdatabase.net/k874835/ 1988-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k874835-pyridoxal-5-phosphate-tablets-fda-510k.jpg K874835 - PYRIDOXAL-5-PHOSPHATE TABLETS K874835 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jan 1988. https://www.510kdatabase.net/k873601/ 1988-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k873601-agc-unicompartmental-knee-prosthesis-fda-510k.jpg K873601 - AGC UNICOMPARTMENTAL KNEE PROSTHESIS K873601 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jan 1988. https://www.510kdatabase.net/k874441/ 1988-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k874441-bard-biopotential-amplifier-fda-510k.jpg K874441 - BARD BIOPOTENTIAL AMPLIFIER K874441 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 1988. https://www.510kdatabase.net/k874792/ 1988-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k874792-model-5013-transvenous-ventricular-fda-510k.jpg K874792 - MODEL 5013 TRANSVENOUS VENTRICULAR PACING LEAD K874792 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jan 1988. https://www.510kdatabase.net/k874796/ 1988-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k874796-model-eeg-4400-with-optional-accessories-fda-510k.jpg K874796 - MODEL EEG 4400 WITH OPTIONAL ACCESSORIES K874796 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Jan 1988. https://www.510kdatabase.net/k874834/ 1988-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k874834-argyle-cardioplegia-cannula-fda-510k.jpg K874834 - ARGYLE CARDIOPLEGIA CANNULA K874834 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sherwood Medical Co.. Cleared Jan 1988. https://www.510kdatabase.net/k875083/ 1988-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k875083-kodak-kodaflex-ii-cassette-fda-510k.jpg K875083 - KODAK KODAFLEX II CASSETTE K875083 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Jan 1988. https://www.510kdatabase.net/k872768/ 1988-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k872768-omniflex-normalized-hip-stem-for-press-fda-510k.jpg K872768 - OMNIFLEX NORMALIZED HIP STEM FOR PRESS-FIT FIXAT. K872768 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Jan 1988. https://www.510kdatabase.net/k875061/ 1988-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k875061-monoject-samplette-amber-capillary-fda-510k.jpg K875061 - MONOJECT SAMPLETTE AMBER CAPILLARY SERUM SEPARATOR K875061 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sherwood Medical Co.. Cleared Jan 1988. https://www.510kdatabase.net/k874147/ 1988-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k874147-qbc-blood-bank-system-fda-510k.jpg K874147 - QBC BLOOD BANK SYSTEM K874147 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jan 1988. https://www.510kdatabase.net/k874626/ 1988-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k874626-revised-labeling-for-syva-fda-510k.jpg K874626 - REVISED LABELING FOR SYVA PHENCYCLIDINE ASSAYS K874626 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jan 1988. https://www.510kdatabase.net/k874876/ 1988-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k874876-gram-gram-miccombo-breakpointcombo-panel-fda-510k.jpg K874876 - GRAM - & GRAM + MIC/COMBO & BREAKPOINT/COMBO PANEL K874876 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jan 1988. https://www.510kdatabase.net/k873874/ 1988-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k873874-cardiofax-v-ecg-8110a-fda-510k.jpg K873874 - CARDIOFAX-V ECG-8110A K873874 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Jan 1988. https://www.510kdatabase.net/k873995/ 1988-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k873995-bard-desai-catheter-electrode-fda-510k.jpg K873995 - BARD DESAI CATHETER ELECTRODE K873995 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 1988. https://www.510kdatabase.net/k874531/ 1988-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k874531-polyflexr-epicardial-439-04-implant-fda-510k.jpg K874531 - POLYFLEX(R) EPICARDIAL 439-04 IMPLANT PACING LEAD K874531 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Jan 1988. https://www.510kdatabase.net/k871881/ 1988-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k871881-model-3000-infusion-pump-fda-510k.jpg K871881 - MODEL 3000 INFUSION PUMP K871881 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jan 1988. https://www.510kdatabase.net/k873746/ 1988-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k873746-auto-syringe-model-as20g-infusion-pump-fda-510k.jpg K873746 - AUTO SYRINGE MODEL AS20G INFUSION PUMP K873746 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jan 1988. https://www.510kdatabase.net/k874930/ 1988-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k874930-model-366-12-adaptaidtm-step-down-fda-510k.jpg K874930 - MODEL 366-12 ADAPTAID(TM) STEP-DOWN ADAPTER K874930 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Jan 1988. https://www.510kdatabase.net/k873371/ 1988-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k873371-urinary-free-catecholamines-fda-510k.jpg K873371 - URINARY FREE CATECHOLAMINES & METANEPHRINES (HPLC) K873371 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Jan 1988. https://www.510kdatabase.net/k874033/ 1988-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k874033-irma-count-hcg-wmono-antibodies-rkcg15x-fda-510k.jpg K874033 - IRMA-COUNT HCG W/MONO. ANTIBODIES RKCG1,5,X K874033 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jan 1988. https://www.510kdatabase.net/k874427/ 1988-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k874427-qbc-system-hemoglobin-fda-510k.jpg K874427 - QBC SYSTEM HEMOGLOBIN K874427 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jan 1988. https://www.510kdatabase.net/k874587/ 1988-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k874587-paramax-urinecsf-calibrator-fda-510k.jpg K874587 - PARAMAX URINE/CSF CALIBRATOR K874587 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jan 1988. https://www.510kdatabase.net/k874702/ 1988-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k874702-revised-labeling-for-syva-barbiturate-fda-510k.jpg K874702 - REVISED LABELING FOR SYVA BARBITURATE ASSAYS K874702 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jan 1988. https://www.510kdatabase.net/k874704/ 1988-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k874704-reflotron-r-amylase-fda-510k.jpg K874704 - REFLOTRON (R) AMYLASE K874704 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jan 1988. https://www.510kdatabase.net/k874856/ 1988-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k874856-emit-convenience-pack-phenytoin-assay-fda-510k.jpg K874856 - EMIT CONVENIENCE PACK: PHENYTOIN ASSAY K874856 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jan 1988. https://www.510kdatabase.net/k874926/ 1988-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k874926-kodak-remote-alarm-unit-fda-510k.jpg K874926 - KODAK REMOTE ALARM UNIT K874926 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Jan 1988. https://www.510kdatabase.net/k874100/ 1987-12-31 monthly 0.5 https://www.510kdatabase.net/og-image/k874100-aml-calcar-femoral-prosthesis-fda-510k.jpg K874100 - AML CALCAR FEMORAL PROSTHESIS K874100 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Dec 1987. https://www.510kdatabase.net/k874032/ 1987-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k874032-irma-count-lh-wmono-antibodies-rklh125-fda-510k.jpg K874032 - IRMA-COUNT LH W/MONO. ANTIBODIES RKLH1,2,5 K874032 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Dec 1987. https://www.510kdatabase.net/k874446/ 1987-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k874446-multi-allergen-ige-fast-screen-fda-510k.jpg K874446 - MULTI-ALLERGEN IGE FAST SCREEN (ENVIRONMENTAL) K874446 is a FDA 510(k) cleared immunology medical device. Manufacturer: 3M Company. Cleared Dec 1987. https://www.510kdatabase.net/k872528/ 1987-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k872528-omnifit-distal-stem-cement-spacers-fda-510k.jpg K872528 - OMNIFIT DISTAL STEM CEMENT SPACERS K872528 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Dec 1987. https://www.510kdatabase.net/k873522/ 1987-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k873522-bard-ambulatory-pca-drug-delivery-system-fda-510k.jpg K873522 - BARD AMBULATORY PCA DRUG DELIVERY SYSTEM K873522 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 1987. https://www.510kdatabase.net/k874074/ 1987-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k874074-temporary-disclosing-solution-fda-510k.jpg K874074 - TEMPORARY DISCLOSING SOLUTION K874074 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Dec 1987. https://www.510kdatabase.net/k874208/ 1987-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k874208-bard-octapolar-electrode-catheter-fda-510k.jpg K874208 - BARD OCTAPOLAR ELECTRODE CATHETER K874208 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 1987. https://www.510kdatabase.net/k874403/ 1987-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k874403-a-series-of-7-inch-continuous-infusion-fda-510k.jpg K874403 - A SERIES OF 7 INCH CONTINUOUS INFUSION SETS K874403 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Quinton, Inc.. Cleared Dec 1987. https://www.510kdatabase.net/k874632/ 1987-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k874632-bent-neck-curlcath-peritoneal-dialysis-fda-510k.jpg K874632 - BENT NECK CURLCATH PERITONEAL DIALYSIS KIT K874632 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quinton, Inc.. Cleared Dec 1987. https://www.510kdatabase.net/k854010/ 1987-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k854010-fructosamine-test-roche-fda-510k.jpg K854010 - FRUCTOSAMINE TEST (ROCHE) K854010 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Dec 1987. https://www.510kdatabase.net/k871835/ 1987-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k871835-glucometer-qc-blood-meter-ames-gluco-fda-510k.jpg K871835 - GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT K871835 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Dec 1987. https://www.510kdatabase.net/k873372/ 1987-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k873372-hva-homovanillic-acid-by-hplc-method-fda-510k.jpg K873372 - HVA & HOMOVANILLIC ACID BY HPLC METHOD K873372 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Dec 1987. https://www.510kdatabase.net/k874625/ 1987-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k874625-emit-convenience-pack-phenobarbital-fda-510k.jpg K874625 - EMIT CONVENIENCE PACK: PHENOBARBITAL ASSAY K874625 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Dec 1987. https://www.510kdatabase.net/k874705/ 1987-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k874705-easy-test-amylase-amyl-item-number-19019-fda-510k.jpg K874705 - EASY-TEST AMYLASE (AMYL), ITEM NUMBER 19019 K874705 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Dec 1987. https://www.510kdatabase.net/k874646/ 1987-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k874646-tdxr-delta-9-cannabinoids-fda-510k.jpg K874646 - TDXR DELTA-9-CANNABINOIDS K874646 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Dec 1987. https://www.510kdatabase.net/k874658/ 1987-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k874658-technicon-rar-analyte-tbg-30-c-and-37-c-fda-510k.jpg K874658 - TECHNICON RA(R) ANALYTE (TBG) (30 C AND 37 C) K874658 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Dec 1987. https://www.510kdatabase.net/k874703/ 1987-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k874703-emit-convenience-pack-gentamicin-assay-fda-510k.jpg K874703 - EMIT CONVENIENCE PACK: GENTAMICIN ASSAY K874703 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Dec 1987. https://www.510kdatabase.net/k874708/ 1987-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k874708-easy-test-glucose-gluc-item-number-19008-fda-510k.jpg K874708 - EASY-TEST GLUCOSE (GLUC), ITEM NUMBER 19008 K874708 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Dec 1987. https://www.510kdatabase.net/k874086/ 1987-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k874086-3m-brand-laser-protection-surgical-fda-510k.jpg K874086 - 3M BRAND LASER PROTECTION SURGICAL DRAPES, 88XX K874086 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Dec 1987. https://www.510kdatabase.net/k874879/ 1987-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k874879-auto-suturer-surgiport-dispos-surg-fda-510k.jpg K874879 - AUTO SUTURE(R) SURGIPORT DISPOS SURG TROCAR/SLEEVE K874879 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Dec 1987. https://www.510kdatabase.net/k871807/ 1987-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k871807-bard-microinfuser-i-insulin-infusion-fda-510k.jpg K871807 - BARD MICROINFUSER I INSULIN INFUSION PUMP K871807 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 1987. https://www.510kdatabase.net/k873519/ 1987-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k873519-paramax-calcium-reagent-fda-510k.jpg K873519 - PARAMAX CALCIUM REAGENT K873519 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Baxter Healthcare Corp. Cleared Dec 1987. https://www.510kdatabase.net/k873530/ 1987-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k873530-paramax-magnesium-reagent-fda-510k.jpg K873530 - PARAMAX MAGNESIUM REAGENT K873530 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Baxter Healthcare Corp. Cleared Dec 1987. https://www.510kdatabase.net/k873743/ 1987-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k873743-paramax-ise-chloride-calibrator-fda-510k.jpg K873743 - PARAMAX ISE CHLORIDE CALIBRATOR K873743 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Baxter Healthcare Corp. Cleared Dec 1987. https://www.510kdatabase.net/k872125/ 1987-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k872125-bard-abg-100-intravascular-oxygen-fda-510k.jpg K872125 - BARD ABG 100 INTRAVASCULAR OXYGEN MONITOR. SYSTEM K872125 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 1987. https://www.510kdatabase.net/k874375/ 1987-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k874375-abbott-testpack-rotavirus-positive-fda-510k.jpg K874375 - ABBOTT TESTPACK ROTAVIRUS POSITIVE CONTROL K874375 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Dec 1987. https://www.510kdatabase.net/k874650/ 1987-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k874650-peritoneal-dialysis-kit-acute-and-fda-510k.jpg K874650 - PERITONEAL DIALYSIS KIT (ACUTE AND CHRONIC FORM) K874650 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quinton, Inc.. Cleared Dec 1987. https://www.510kdatabase.net/k871490/ 1987-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k871490-colorview-860-or-ssd-860-pulse-fda-510k.jpg K871490 - COLORVIEW 860 OR SSD-860 PULSE ECHO/MODIFICATION K871490 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Dec 1987. https://www.510kdatabase.net/k873847/ 1987-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k873847-cormed-iii-ambulatory-infusion-pump-fda-510k.jpg K873847 - CORMED III AMBULATORY INFUSION PUMP K873847 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 1987. https://www.510kdatabase.net/k874167/ 1987-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k874167-medtronic-permanent-lead-introducer-fda-510k.jpg K874167 - MEDTRONIC PERMANENT LEAD INTRODUCER K874167 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Dec 1987. https://www.510kdatabase.net/k873921/ 1987-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k873921-model-366-30-adaptaidtm-adapter-sleeve-fda-510k.jpg K873921 - MODEL 366-30 ADAPTAID(TM) ADAPTER SLEEVE K873921 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Dec 1987. https://www.510kdatabase.net/k874426/ 1987-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k874426-new-antimicro-agentsaugmentinaztreonamci-fda-510k.jpg K874426 - NEW ANTIMICRO. AGENTS:AUGMENTIN,AZTREONAM,CIPROFLO K874426 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Dec 1987. https://www.510kdatabase.net/k874428/ 1987-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k874428-auto-suture-purse-string-applier-fda-510k.jpg K874428 - AUTO SUTURE PURSE STRING APPLIER* K874428 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Dec 1987. https://www.510kdatabase.net/k873903/ 1987-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k873903-abbott-pap-eia-fda-510k.jpg K873903 - ABBOTT PAP-EIA K873903 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Dec 1987. https://www.510kdatabase.net/k871517/ 1987-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k871517-olympus-pf-25-ultrathin-angioscope-fda-510k.jpg K871517 - OLYMPUS PF-25 ULTRATHIN ANGIOSCOPE K871517 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Olympus Corp.. Cleared Nov 1987. https://www.510kdatabase.net/k873367/ 1987-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k873367-olympus-lus-ultrasonic-lithotripter-fda-510k.jpg K873367 - OLYMPUS LUS ULTRASONIC LITHOTRIPTER K873367 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Corp.. Cleared Nov 1987. https://www.510kdatabase.net/k873438/ 1987-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k873438-usci-r-8f-large-lumen-soft-tip-guide-fda-510k.jpg K873438 - USCI (R) 8F LARGE LUMEN SOFT TIP GUIDE CATHETER K873438 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 1987. https://www.510kdatabase.net/k874031/ 1987-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k874031-irma-count-ferritin-wmono-antibodies-fda-510k.jpg K874031 - IRMA-COUNT FERRITIN W/MONO. ANTIBODIES RKFE1,2,5 K874031 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Nov 1987. https://www.510kdatabase.net/k874261/ 1987-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k874261-iqqca-total-bilirubin-fda-510k.jpg K874261 - IQ/QCA TOTAL BILIRUBIN K874261 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Nov 1987. https://www.510kdatabase.net/k874476/ 1987-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k874476-easy-test-total-protein-tp-item-number-fda-510k.jpg K874476 - EASY-TEST TOTAL PROTEIN (TP) ITEM NUMBER: 19011 K874476 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Nov 1987. https://www.510kdatabase.net/k874142/ 1987-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k874142-titan-gel-rep-ldh-30-hv-fda-510k.jpg K874142 - TITAN GEL REP LDH-30 HV K874142 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Nov 1987. https://www.510kdatabase.net/k874145/ 1987-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k874145-titan-gel-rep-ldh-6-hv-fda-510k.jpg K874145 - TITAN GEL REP LDH-6 HV K874145 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Nov 1987. https://www.510kdatabase.net/k874397/ 1987-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k874397-easy-test-hdl-cholesterol-item-number-fda-510k.jpg K874397 - EASY-TEST HDL CHOLESTEROL ITEM NUMBER 16683 K874397 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Nov 1987. https://www.510kdatabase.net/k874578/ 1987-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k874578-emit-convenience-pack-theophylline-assay-fda-510k.jpg K874578 - EMIT CONVENIENCE PACK: THEOPHYLLINE ASSAY K874578 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Nov 1987. https://www.510kdatabase.net/k871928/ 1987-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k871928-carbon-dioxide-insufflatorlaparo-hi-fda-510k.jpg K871928 - CARBON DIOXIDE INSUFFLATOR/LAPARO & HI FLOW LASER/ K871928 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Medline Industries, Inc.. Cleared Nov 1987. https://www.510kdatabase.net/k872818/ 1987-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k872818-reflotron-bilirubin-fda-510k.jpg K872818 - REFLOTRON BILIRUBIN K872818 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Nov 1987. https://www.510kdatabase.net/k873183/ 1987-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k873183-tdxr-multiconstit-controls-for-abused-fda-510k.jpg K873183 - TDXR MULTICONSTIT. CONTROLS FOR ABUSED DRUG ASSAYS K873183 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1987. https://www.510kdatabase.net/k873454/ 1987-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k873454-paramax-phosphorus-reagent-fda-510k.jpg K873454 - PARAMAX PHOSPHORUS REAGENT K873454 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Baxter Healthcare Corp. Cleared Nov 1987. https://www.510kdatabase.net/k873456/ 1987-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k873456-paramax-uric-acid-reagent-fda-510k.jpg K873456 - PARAMAX URIC ACID REAGENT K873456 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Baxter Healthcare Corp. Cleared Nov 1987. https://www.510kdatabase.net/k873520/ 1987-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k873520-paramax-amylase-reagent-fda-510k.jpg K873520 - PARAMAX AMYLASE REAGENT K873520 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Baxter Healthcare Corp. Cleared Nov 1987. https://www.510kdatabase.net/k873531/ 1987-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k873531-paramax-creatinine-reagent-fda-510k.jpg K873531 - PARAMAX CREATININE REAGENT K873531 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Baxter Healthcare Corp. Cleared Nov 1987. https://www.510kdatabase.net/k873532/ 1987-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k873532-paramax-urea-nitrogen-reagent-fda-510k.jpg K873532 - PARAMAX UREA NITROGEN REAGENT K873532 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Baxter Healthcare Corp. Cleared Nov 1987. https://www.510kdatabase.net/k873791/ 1987-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k873791-model-500e-infant-monitoring-system-fda-510k.jpg K873791 - MODEL 500E INFANT MONITORING SYSTEM K873791 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Nov 1987. https://www.510kdatabase.net/k873936/ 1987-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k873936-modified-paramax-glucose-reagent-fda-510k.jpg K873936 - MODIFIED PARAMAX GLUCOSE REAGENT K873936 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Baxter Healthcare Corp. Cleared Nov 1987. https://www.510kdatabase.net/k873944/ 1987-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k873944-a-gent-liquid-amylase-fda-510k.jpg K873944 - A-GENT LIQUID AMYLASE K873944 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1987. https://www.510kdatabase.net/k874143/ 1987-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k874143-titan-gel-rep-ldh-12-hv-fda-510k.jpg K874143 - TITAN GEL REP LDH-12 HV K874143 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Nov 1987. https://www.510kdatabase.net/k874144/ 1987-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k874144-titan-gel-rep-cpk-6-hv-fda-510k.jpg K874144 - TITAN GEL REP CPK-6 HV K874144 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Nov 1987. https://www.510kdatabase.net/k874230/ 1987-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k874230-precinorm-l-fda-510k.jpg K874230 - PRECINORM L K874230 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Nov 1987. https://www.510kdatabase.net/k874376/ 1987-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k874376-revised-labeling-for-syva-fda-510k.jpg K874376 - REVISED LABELING FOR SYVA BENZODIAZEPINE ASSAYS K874376 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Nov 1987. https://www.510kdatabase.net/k874394/ 1987-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k874394-quantumr-models-253-19v-254-20v-pulse-fda-510k.jpg K874394 - QUANTUM(R) MODELS 253-19V & 254-20V PULSE GENERA. K874394 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Nov 1987. https://www.510kdatabase.net/k874435/ 1987-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k874435-bicarbonate-fda-510k.jpg K874435 - BICARBONATE K874435 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Nov 1987. https://www.510kdatabase.net/k874477/ 1987-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k874477-easy-test-urea-nitrogen-bun-item-fda-510k.jpg K874477 - EASY-TEST UREA NITROGEN (BUN) ITEM NUMBER: 19010 K874477 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Nov 1987. https://www.510kdatabase.net/k874483/ 1987-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k874483-revised-labeling-for-tdx-barbiturates-fda-510k.jpg K874483 - REVISED LABELING FOR TDX BARBITURATES K874483 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1987. https://www.510kdatabase.net/k874484/ 1987-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k874484-revised-labeling-for-tdx-phencyclidine-fda-510k.jpg K874484 - REVISED LABELING FOR TDX PHENCYCLIDINE K874484 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1987. https://www.510kdatabase.net/k874485/ 1987-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k874485-revised-labeling-for-opiates-fda-510k.jpg K874485 - REVISED LABELING FOR OPIATES K874485 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1987. https://www.510kdatabase.net/k874486/ 1987-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k874486-revised-labeling-for-tdx-fda-510k.jpg K874486 - REVISED LABELING FOR TDX AMPHETAMINE/METHAMPHETA. K874486 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1987. https://www.510kdatabase.net/k874487/ 1987-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k874487-revised-labeling-for-tdx-cocaine-fda-510k.jpg K874487 - REVISED LABELING FOR TDX COCAINE METABOLITE K874487 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1987. https://www.510kdatabase.net/k874488/ 1987-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k874488-revised-labeling-for-tdx-cannabinoids-fda-510k.jpg K874488 - REVISED LABELING FOR TDX CANNABINOIDS K874488 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1987. https://www.510kdatabase.net/k874489/ 1987-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k874489-revised-labeling-for-tdx-benzodiazepines-fda-510k.jpg K874489 - REVISED LABELING FOR TDX BENZODIAZEPINES K874489 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1987. https://www.510kdatabase.net/k873384/ 1987-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k873384-chromogenic-system-analyzer-fda-510k.jpg K873384 - CHROMOGENIC SYSTEM ANALYZER SPECTROPHOTOMETER CSA K873384 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Nov 1987. https://www.510kdatabase.net/k874269/ 1987-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k874269-revised-labeling-for-cannabinoids-test-fda-510k.jpg K874269 - REVISED LABELING FOR CANNABINOIDS TEST KIT K874269 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Nov 1987. https://www.510kdatabase.net/k874425/ 1987-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k874425-ciprofloxacin-5-mcg-sensi-disc-fda-510k.jpg K874425 - CIPROFLOXACIN 5 MCG SENSI-DISC K874425 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Nov 1987. https://www.510kdatabase.net/k873645/ 1987-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k873645-stainless-22-13-5-suture-wire-fda-510k.jpg K873645 - STAINLESS 22-13-5 SUTURE WIRE K873645 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Zimmer, Inc.. Cleared Nov 1987. https://www.510kdatabase.net/k872860/ 1987-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k872860-insufflator-tubing-fda-510k.jpg K872860 - INSUFFLATOR TUBING K872860 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Medline Industries, Inc.. Cleared Nov 1987. https://www.510kdatabase.net/k874210/ 1987-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k874210-revised-labeling-for-abuscreen-eia-fda-510k.jpg K874210 - REVISED LABELING FOR ABUSCREEN EIA BARBITURATE K874210 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Nov 1987. https://www.510kdatabase.net/k874213/ 1987-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k874213-aca-du-pont-urine-cocaine-metabolite-u-fda-510k.jpg K874213 - ACA DU PONT URINE COCAINE METABOLITE (U COC)SCREEN K874213 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Nov 1987. https://www.510kdatabase.net/k874223/ 1987-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k874223-emit-tobramycin-assay-fda-510k.jpg K874223 - EMIT TOBRAMYCIN ASSAY K874223 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Nov 1987. https://www.510kdatabase.net/k874265/ 1987-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k874265-revised-labeling-for-benzodiazepine-fda-510k.jpg K874265 - REVISED LABELING FOR BENZODIAZEPINE TEST KIT K874265 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Nov 1987. https://www.510kdatabase.net/k874266/ 1987-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k874266-revised-labeling-for-barbiturate-test-fda-510k.jpg K874266 - REVISED LABELING FOR BARBITURATE TEST KIT K874266 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Nov 1987. https://www.510kdatabase.net/k874267/ 1987-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k874267-revised-labeling-for-pcp-test-kit-fda-510k.jpg K874267 - REVISED LABELING FOR PCP TEST KIT K874267 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Nov 1987. https://www.510kdatabase.net/k874268/ 1987-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k874268-revised-labeling-for-morphine-test-kit-fda-510k.jpg K874268 - REVISED LABELING FOR MORPHINE TEST KIT K874268 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Nov 1987. https://www.510kdatabase.net/k874270/ 1987-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k874270-revised-labeling-for-lsd-test-kit-fda-510k.jpg K874270 - REVISED LABELING FOR LSD TEST KIT K874270 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Nov 1987. https://www.510kdatabase.net/k874271/ 1987-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k874271-revised-labeling-for-cocainecocaine-fda-510k.jpg K874271 - REVISED LABELING FOR COCAINE/COCAINE META. TEST K874271 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Nov 1987. https://www.510kdatabase.net/k874272/ 1987-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k874272-revised-labeling-for-methaqualone-test-fda-510k.jpg K874272 - REVISED LABELING FOR METHAQUALONE TEST KIT K874272 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Nov 1987. https://www.510kdatabase.net/k874273/ 1987-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k874273-revised-labeling-for-amphetamine-test-fda-510k.jpg K874273 - REVISED LABELING FOR AMPHETAMINE TEST KIT K874273 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Nov 1987. https://www.510kdatabase.net/k874274/ 1987-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k874274-revised-labeling-for-amphetamine-test-fda-510k.jpg K874274 - REVISED LABELING FOR AMPHETAMINE TEST KIT K874274 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Nov 1987. https://www.510kdatabase.net/k874101/ 1987-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k874101-emds-n-acetylprocainamide-calibrator-fda-510k.jpg K874101 - EMDS N-ACETYLPROCAINAMIDE CALIBRATOR #67635/95 K874101 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Nov 1987. https://www.510kdatabase.net/k870885/ 1987-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k870885-medtronic-model-5513-endocardial-fda-510k.jpg K870885 - MEDTRONIC MODEL 5513 ENDOCARDIAL PACING LEAD K870885 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Nov 1987. https://www.510kdatabase.net/k871198/ 1987-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k871198-bone-marrow-collection-kit-and-stand-fda-510k.jpg K871198 - BONE MARROW COLLECTION KIT AND STAND K871198 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Nov 1987. https://www.510kdatabase.net/k873423/ 1987-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k873423-maxima-collapsible-venous-reservoir-fda-510k.jpg K873423 - MAXIMA* COLLAPSIBLE VENOUS RESERVOIR BAG & HOLDER K873423 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Nov 1987. https://www.510kdatabase.net/k874088/ 1987-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k874088-easy-test-creatinine-crea-item-no-19009-fda-510k.jpg K874088 - EASY-TEST CREATININE (CREA) ITEM NO. 19009 K874088 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Nov 1987. https://www.510kdatabase.net/k873894/ 1987-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k873894-continu-flo-solution-wcheck-valve-2-y-fda-510k.jpg K873894 - CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITE K873894 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Nov 1987. https://www.510kdatabase.net/k874102/ 1987-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k874102-emds-procainamide-calibrator-item-no-fda-510k.jpg K874102 - EMDS PROCAINAMIDE CALIBRATOR ITEM NO. 67634/95 K874102 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Nov 1987. https://www.510kdatabase.net/k874117/ 1987-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k874117-medtronic-model-6550-adjustable-fda-510k.jpg K874117 - MEDTRONIC MODEL 6550 ADJUSTABLE HEMOSTASIS VALVE K874117 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Nov 1987. https://www.510kdatabase.net/k874146/ 1987-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k874146-titan-gel-rep-cpk-12-hv-fda-510k.jpg K874146 - TITAN GEL REP CPK-12 HV K874146 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Nov 1987. https://www.510kdatabase.net/k864294/ 1987-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k864294-henke-ject-pressure-syringe-modification-fda-510k.jpg K864294 - HENKE-JECT PRESSURE SYRINGE (MODIFICATION) K864294 is a FDA 510(k) cleared dental medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Nov 1987. https://www.510kdatabase.net/k872822/ 1987-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k872822-model-78576a-paper-chart-recorder-fda-510k.jpg K872822 - MODEL 78576A PAPER CHART RECORDER K872822 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Nov 1987. https://www.510kdatabase.net/k873998/ 1987-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k873998-total-ige-fast-tm-test-package-fda-510k.jpg K873998 - TOTAL IGE FAST (TM) TEST PACKAGE K873998 is a FDA 510(k) cleared immunology medical device. Manufacturer: 3M Company. Cleared Nov 1987. https://www.510kdatabase.net/k874115/ 1987-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k874115-no-1000-h-for-immunofluorometric-deter-fda-510k.jpg K874115 - NO. 1000-H FOR IMMUNOFLUOROMETRIC DETER. OF (ANA) K874115 is a FDA 510(k) cleared immunology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Nov 1987. https://www.510kdatabase.net/k874141/ 1987-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k874141-titan-gel-rep-cpkldh-isoenzyme-control-fda-510k.jpg K874141 - TITAN GEL REP CPK/LDH ISOENZYME CONTROL K874141 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Nov 1987. https://www.510kdatabase.net/k874153/ 1987-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k874153-easy-test-phosphorus-phos-item-no-16687-fda-510k.jpg K874153 - EASY-TEST PHOSPHORUS (PHOS) ITEM NO. 16687 K874153 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Nov 1987. https://www.510kdatabase.net/k873735/ 1987-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k873735-medtronic-catheter-access-port-model-fda-510k.jpg K873735 - MEDTRONIC CATHETER ACCESS PORT MODEL 8500 K873735 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medtronic Vascular. Cleared Nov 1987. https://www.510kdatabase.net/k874139/ 1987-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k874139-titan-gel-rep-cpk-30-hv-fda-510k.jpg K874139 - TITAN GEL REP CPK-30 HV K874139 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Nov 1987. https://www.510kdatabase.net/k874140/ 1987-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k874140-titan-gel-rep-simultaneous-ck-ld-fda-510k.jpg K874140 - TITAN GEL REP SIMULTANEOUS CK-LD ISOENZYME PROCED. K874140 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Nov 1987. https://www.510kdatabase.net/k874229/ 1987-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k874229-anatomic-total-hip-fda-510k.jpg K874229 - ANATOMIC TOTAL HIP K874229 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Nov 1987. https://www.510kdatabase.net/k873048/ 1987-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k873048-kodak-sv6500-printer-sv65-finisher-fda-510k.jpg K873048 - KODAK SV6500 PRINTER/ SV65 FINISHER/ SV100 SET K873048 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Oct 1987. https://www.510kdatabase.net/k873425/ 1987-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k873425-easy-test-salicylate-sal-16691-fda-510k.jpg K873425 - EASY-TEST SALICYLATE (SAL) #16691 K873425 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Oct 1987. https://www.510kdatabase.net/k873426/ 1987-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k873426-easy-test-emitr-amikacin-amik-no-16645-fda-510k.jpg K873426 - EASY-TEST EMIT(R) AMIKACIN (AMIK) NO. 16645 K873426 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Oct 1987. https://www.510kdatabase.net/k873436/ 1987-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k873436-emds-amikacin-calibrator-item-no-6763395-fda-510k.jpg K873436 - EMDS AMIKACIN CALIBRATOR ITEM NO. 67633/95 K873436 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Oct 1987. https://www.510kdatabase.net/k873518/ 1987-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k873518-affinity-total-thyroxine-immunit-fda-510k.jpg K873518 - AFFINITY TOTAL THYROXINE IMMUNIT K873518 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1987. https://www.510kdatabase.net/k873635/ 1987-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k873635-easy-test-alkaline-phosphatase-alp-19021-fda-510k.jpg K873635 - EASY-TEST ALKALINE PHOSPHATASE (ALP) #19021 K873635 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Oct 1987. https://www.510kdatabase.net/k873855/ 1987-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k873855-emit-qst-gentamicin-assay-fda-510k.jpg K873855 - EMIT QST GENTAMICIN ASSAY K873855 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Oct 1987. https://www.510kdatabase.net/k873898/ 1987-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k873898-revised-labeling-for-syva-opiate-assays-fda-510k.jpg K873898 - REVISED LABELING FOR SYVA OPIATE ASSAYS K873898 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Oct 1987. https://www.510kdatabase.net/k873994/ 1987-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k873994-easy-test-albumin-alb-item-no-19039-fda-510k.jpg K873994 - EASY-TEST ALBUMIN (ALB), ITEM NO. 19039 K873994 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Oct 1987. https://www.510kdatabase.net/k874080/ 1987-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k874080-revised-labeling-for-syva-amphetamine-fda-510k.jpg K874080 - REVISED LABELING FOR SYVA AMPHETAMINE ASSAY K874080 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Oct 1987. https://www.510kdatabase.net/k872120/ 1987-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k872120-seralyzer-iii-blood-chemistry-analyzer-fda-510k.jpg K872120 - SERALYZER III BLOOD CHEMISTRY ANALYZER K872120 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Oct 1987. https://www.510kdatabase.net/k872379/ 1987-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k872379-insallburstein-ii-modular-total-knee-fda-510k.jpg K872379 - INSALL/BURSTEIN* II MODULAR TOTAL KNEE K872379 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Oct 1987. https://www.510kdatabase.net/k872986/ 1987-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k872986-model-28200cshoulderankleelbowhiptmjsm-fda-510k.jpg K872986 - MODEL 28200C/SHOULDER/ANKLE/ELBOW/HIP/TMJ/SM JOINT K872986 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Oct 1987. https://www.510kdatabase.net/k873459/ 1987-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k873459-alta-systems-tibialupper-extremity-fda-510k.jpg K873459 - ALTA SYSTEMS TIBIAL/UPPER EXTREMITY DIAPHYSEAL PLT K873459 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Oct 1987. https://www.510kdatabase.net/k873585/ 1987-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k873585-porous-coated-acetabular-cup-fda-510k.jpg K873585 - POROUS COATED ACETABULAR CUP K873585 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Oct 1987. https://www.510kdatabase.net/k873854/ 1987-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k873854-emit-gentamicin-assay-fda-510k.jpg K873854 - EMIT GENTAMICIN ASSAY K873854 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Oct 1987. https://www.510kdatabase.net/k873899/ 1987-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k873899-revised-labeling-for-syva-methadone-fda-510k.jpg K873899 - REVISED LABELING FOR SYVA METHADONE ASSAYS K873899 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Oct 1987. https://www.510kdatabase.net/k874079/ 1987-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k874079-revised-labeling-for-syva-cannabinoid-fda-510k.jpg K874079 - REVISED LABELING FOR SYVA CANNABINOID ASSAYS K874079 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Oct 1987. https://www.510kdatabase.net/k874156/ 1987-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k874156-sticker-label-for-drugs-of-abuse-assays-fda-510k.jpg K874156 - STICKER LABEL FOR DRUGS OF ABUSE ASSAYS K874156 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Oct 1987. https://www.510kdatabase.net/k874199/ 1987-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k874199-revised-labeling-for-syva-methaqualone-fda-510k.jpg K874199 - REVISED LABELING FOR SYVA METHAQUALONE ASSAYS K874199 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Oct 1987. https://www.510kdatabase.net/k874200/ 1987-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k874200-revised-labeling-for-syva-propoxyphene-fda-510k.jpg K874200 - REVISED LABELING FOR SYVA PROPOXYPHENE ASSAYS K874200 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Oct 1987. https://www.510kdatabase.net/k874201/ 1987-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k874201-revised-labeling-for-syva-cocaine-fda-510k.jpg K874201 - REVISED LABELING FOR SYVA COCAINE METABOLITE ASSAY K874201 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Oct 1987. https://www.510kdatabase.net/k873213/ 1987-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k873213-hickman-plastic-subcutaneous-port-fda-510k.jpg K873213 - HICKMAN PLASTIC SUBCUTANEOUS PORT K873213 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 1987. https://www.510kdatabase.net/k873584/ 1987-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k873584-modified-q4000-q3040-electrocardiograph-fda-510k.jpg K873584 - MODIFIED Q4000 & Q3040 ELECTROCARDIOGRAPH MONITOR K873584 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Oct 1987. https://www.510kdatabase.net/k873688/ 1987-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k873688-aneuroplastic-acrylic-aneuryomorrhaply-fda-510k.jpg K873688 - ANEUROPLASTIC, ACRYLIC ANEURYOMORRHAPLY MATERIAL K873688 is a FDA 510(k) cleared neurology medical device. Manufacturer: Dentsply Intl.. Cleared Oct 1987. https://www.510kdatabase.net/k873689/ 1987-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k873689-cranioplastic-acrylic-cranioplasty-fda-510k.jpg K873689 - CRANIOPLASTIC, ACRYLIC CRANIOPLASTY MATERIAL K873689 is a FDA 510(k) cleared neurology medical device. Manufacturer: Dentsply Intl.. Cleared Oct 1987. https://www.510kdatabase.net/k873141/ 1987-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k873141-laser-resistant-drape-fda-510k.jpg K873141 - LASER RESISTANT DRAPE K873141 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Oct 1987. https://www.510kdatabase.net/k873197/ 1987-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k873197-amk-total-knee-system-patella-component-fda-510k.jpg K873197 - AMK TOTAL KNEE SYSTEM, PATELLA COMPONENT K873197 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Oct 1987. https://www.510kdatabase.net/k873786/ 1987-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k873786-smith-nephew-daylightertm-fda-510k.jpg K873786 - SMITH & NEPHEW DAYLIGHTER(TM) K873786 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 1987. https://www.510kdatabase.net/k873873/ 1987-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k873873-resubmitted-micron-transfusion-filter-fda-510k.jpg K873873 - RESUBMITTED MICRON TRANSFUSION FILTER K873873 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Oct 1987. https://www.510kdatabase.net/k870726/ 1987-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k870726-rt5000-echocardiography-h4100cce-fda-510k.jpg K870726 - RT5000 ECHOCARDIOGRAPHY #H4100C/CE K870726 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: General Electric Co.. Cleared Oct 1987. https://www.510kdatabase.net/k873050/ 1987-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k873050-vascular-access-catheter-fda-510k.jpg K873050 - VASCULAR ACCESS CATHETER W/ANTIMICROBIAL CUFF K873050 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 1987. https://www.510kdatabase.net/k873051/ 1987-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k873051-stratusr-hfsh-fluorometric-enzyme-fda-510k.jpg K873051 - STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAY K873051 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Oct 1987. https://www.510kdatabase.net/k873250/ 1987-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k873250-isomune-amylase-and-isomune-amylase-fda-510k.jpg K873250 - ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CONTROL K873250 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Oct 1987. https://www.510kdatabase.net/k873342/ 1987-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k873342-bile-acids-controls-fda-510k.jpg K873342 - BILE ACIDS CONTROLS K873342 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Oct 1987. https://www.510kdatabase.net/k873386/ 1987-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k873386-titan-gel-ldh-rep-system-fda-510k.jpg K873386 - TITAN GEL LDH REP SYSTEM K873386 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Oct 1987. https://www.510kdatabase.net/k873399/ 1987-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k873399-titan-gel-cpk-rep-system-fda-510k.jpg K873399 - TITAN GEL CPK REP SYSTEM K873399 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Oct 1987. https://www.510kdatabase.net/k873572/ 1987-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k873572-il-35260-il-test-amylase-reagent-fda-510k.jpg K873572 - IL 35260, IL TEST AMYLASE REAGENT K873572 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Oct 1987. https://www.510kdatabase.net/k873623/ 1987-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k873623-aca-urine-barbiturates-screen-method-fda-510k.jpg K873623 - ACA URINE BARBITURATES SCREEN METHOD K873623 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Oct 1987. https://www.510kdatabase.net/k873984/ 1987-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k873984-automatic-peritoneal-dialysis-cycler-fda-510k.jpg K873984 - AUTOMATIC PERITONEAL DIALYSIS CYCLER SET (5C4437) K873984 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Oct 1987. https://www.510kdatabase.net/k873363/ 1987-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k873363-uric-acid-pap-fda-510k.jpg K873363 - URIC ACID PAP K873363 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Oct 1987. https://www.510kdatabase.net/k873750/ 1987-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k873750-labeling-changes-coat-a-count-fda-510k.jpg K873750 - LABELING CHANGES COAT-A-COUNT METHADONE IN URINE K873750 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Oct 1987. https://www.510kdatabase.net/k873751/ 1987-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k873751-labeling-change-coat-a-count-cocaine-fda-510k.jpg K873751 - LABELING CHANGE COAT-A-COUNT COCAINE METABOLITE K873751 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Oct 1987. https://www.510kdatabase.net/k873752/ 1987-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k873752-labeling-change-cocaine-metabolite-fda-510k.jpg K873752 - LABELING CHANGE COCAINE METABOLITE DOUBLE ANTIBODY K873752 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Oct 1987. https://www.510kdatabase.net/k873753/ 1987-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k873753-labeling-change-cannabinoids-double-fda-510k.jpg K873753 - LABELING CHANGE CANNABINOIDS DOUBLE ANTI. IN URINE K873753 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Oct 1987. https://www.510kdatabase.net/k873754/ 1987-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k873754-labeling-change-barbiturates-in-urine-fda-510k.jpg K873754 - LABELING CHANGE BARBITURATES IN URINE K873754 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Oct 1987. https://www.510kdatabase.net/k873755/ 1987-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k873755-labeling-change-amphetamine-double-fda-510k.jpg K873755 - LABELING CHANGE AMPHETAMINE DOUBLE ANTIBODY K873755 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Oct 1987. https://www.510kdatabase.net/k873756/ 1987-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k873756-labeling-change-pcp-phencyclidine-in-fda-510k.jpg K873756 - LABELING CHANGE PCP (PHENCYCLIDINE) IN URINE K873756 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Oct 1987. https://www.510kdatabase.net/k873757/ 1987-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k873757-labeling-change-coat-a-count-morphine-fda-510k.jpg K873757 - LABELING CHANGE COAT-A-COUNT MORPHINE IN URINE K873757 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Oct 1987. https://www.510kdatabase.net/k873758/ 1987-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k873758-labeling-change-coat-a-count-serum-fda-510k.jpg K873758 - LABELING CHANGE COAT-A-COUNT SERUM MORPHINE K873758 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Oct 1987. https://www.510kdatabase.net/k873759/ 1987-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k873759-labeling-change-coat-a-count-fda-510k.jpg K873759 - LABELING CHANGE COAT-A-COUNT METHAQUALONE K873759 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Oct 1987. https://www.510kdatabase.net/k874044/ 1987-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k874044-intra-articular-arthroscopic-shaver-fda-510k.jpg K874044 - INTRA-ARTICULAR ARTHROSCOPIC SHAVER K874044 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Medline Industries, Inc.. Cleared Oct 1987. https://www.510kdatabase.net/k872364/ 1987-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k872364-hemodialysis-sps-model-550-code-5m1309-fda-510k.jpg K872364 - HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309 K872364 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Oct 1987. https://www.510kdatabase.net/k872231/ 1987-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k872231-bard-epicardial-electrode-array-fda-510k.jpg K872231 - BARD EPICARDIAL ELECTRODE ARRAY K872231 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 1987. https://www.510kdatabase.net/k872927/ 1987-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k872927-davol-intraoperative-autotransfusion-kit-fda-510k.jpg K872927 - DAVOL INTRAOPERATIVE AUTOTRANSFUSION KIT K872927 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 1987. https://www.510kdatabase.net/k873528/ 1987-10-09 monthly 0.5 https://www.510kdatabase.net/og-image/k873528-modified-models-253-19-254-20-quantum-fda-510k.jpg K873528 - MODIFIED MODELS 253-19 & 254-20 QUANTUM GENERATORS K873528 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Oct 1987. https://www.510kdatabase.net/k872179/ 1987-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k872179-codman-neurolase-laser-system-fda-510k.jpg K872179 - CODMAN NEUROLASE LASER SYSTEM K872179 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Oct 1987. https://www.510kdatabase.net/k873539/ 1987-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k873539-aca-urine-drugs-of-abuse-control-fda-510k.jpg K873539 - ACA URINE DRUGS OF ABUSE CONTROL K873539 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Oct 1987. https://www.510kdatabase.net/k873727/ 1987-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k873727-pull-apart-introducer-sheath-fda-510k.jpg K873727 - PULL-APART INTRODUCER (SHEATH) K873727 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Oct 1987. https://www.510kdatabase.net/k873524/ 1987-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k873524-affinity-hcg-immunit-polyclonal-fda-510k.jpg K873524 - AFFINITY HCG IMMUNIT (POLYCLONAL) K873524 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1987. https://www.510kdatabase.net/k873675/ 1987-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k873675-modified-3587-resume-se-43487-pisces-fda-510k.jpg K873675 - MODIFIED #3587 RESUME SE-4/#3487 PISCES-QUAD K873675 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Oct 1987. https://www.510kdatabase.net/k872775/ 1987-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k872775-leucoprep-brand-tube-fda-510k.jpg K872775 - LEUCOPREP BRAND TUBE K872775 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1987. https://www.510kdatabase.net/k873037/ 1987-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k873037-con-doa-tm-drugs-of-abuse-urine-control-fda-510k.jpg K873037 - CON-DOA (TM) DRUGS OF ABUSE URINE CONTROL K873037 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Oct 1987. https://www.510kdatabase.net/k873365/ 1987-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k873365-creatinine-reagent-fda-510k.jpg K873365 - CREATININE REAGENT K873365 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Oct 1987. https://www.510kdatabase.net/k873538/ 1987-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k873538-aca-urine-benzodiazepines-ubenz-screen-fda-510k.jpg K873538 - ACA URINE BENZODIAZEPINES (UBENZ) SCREEN METHOD K873538 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Oct 1987. https://www.510kdatabase.net/k873547/ 1987-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k873547-titan-gel-hdl-cholesterol-kit-fda-510k.jpg K873547 - TITAN GEL HDL CHOLESTEROL KIT K873547 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Oct 1987. https://www.510kdatabase.net/k873551/ 1987-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k873551-conjugated-bilirubin-cbil-item-no-fda-510k.jpg K873551 - CONJUGATED BILIRUBIN (CBIL) ITEM NO. 67684/95 K873551 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Oct 1987. https://www.510kdatabase.net/k873622/ 1987-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k873622-aca-du-pont-urine-amphetamines-u-amp-fda-510k.jpg K873622 - ACA DU PONT URINE AMPHETAMINES (U AMP) SCREEN METH K873622 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Oct 1987. https://www.510kdatabase.net/k870794/ 1987-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k870794-mem-4104-evoked-responseelectromyography-fda-510k.jpg K870794 - MEM-4104 EVOKED RESPONSE/ELECTROMYOGRAPHY RECORDER K870794 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Sep 1987. https://www.510kdatabase.net/k872166/ 1987-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k872166-facscan-flow-cytometer-reticcount-reti-fda-510k.jpg K872166 - FACSCAN FLOW CYTOMETER - RETICCOUNT RETI. ENU. KIT K872166 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1987. https://www.510kdatabase.net/k872241/ 1987-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k872241-lifescope-12-bsm-8500a-patient-monitor-fda-510k.jpg K872241 - LIFESCOPE 12, BSM 8500A PATIENT MONITOR K872241 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Sep 1987. https://www.510kdatabase.net/k872652/ 1987-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k872652-upgraded-auto-peritoneal-dialysis-fda-510k.jpg K872652 - UPGRADED AUTO PERITONEAL DIALYSIS CYCLER SYSTEM K872652 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Sep 1987. https://www.510kdatabase.net/k872719/ 1987-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k872719-expanded-use-of-hardshell-venous-fda-510k.jpg K872719 - EXPANDED USE OF HARDSHELL VENOUS RESERV. W/FILTER K872719 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Sep 1987. https://www.510kdatabase.net/k873394/ 1987-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k873394-oval-pull-apart-sheathdilator-fda-510k.jpg K873394 - OVAL PULL-APART SHEATH/DILATOR K873394 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Sep 1987. https://www.510kdatabase.net/k873171/ 1987-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k873171-stratusr-ck-mb-fluorometric-enzyme-fda-510k.jpg K873171 - STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY K873171 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Sep 1987. https://www.510kdatabase.net/k873350/ 1987-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k873350-easy-test-emit-procainamide-proc-16648-fda-510k.jpg K873350 - EASY-TEST EMIT PROCAINAMIDE (PROC) #16648 K873350 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Sep 1987. https://www.510kdatabase.net/k873681/ 1987-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k873681-alkaline-phosphatase-alk-p-testpack-fda-510k.jpg K873681 - ALKALINE PHOSPHATASE (ALK P) TESTPACK #67690/95 K873681 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Sep 1987. https://www.510kdatabase.net/k862970/ 1987-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k862970-temporary-myocardial-pacing-lead-model-fda-510k.jpg K862970 - TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500 K862970 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Sep 1987. https://www.510kdatabase.net/k871970/ 1987-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k871970-double-antibody-ultra-pth-kptd1-and-fda-510k.jpg K871970 - DOUBLE ANTIBODY ULTRA-PTH #KPTD1 AND KPTD2 K871970 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Sep 1987. https://www.510kdatabase.net/k873514/ 1987-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k873514-johnson-johnson-bipolar-endoprothesis-fda-510k.jpg K873514 - JOHNSON & JOHNSON BIPOLAR ENDOPROTHESIS K873514 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Sep 1987. https://www.510kdatabase.net/k872526/ 1987-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k872526-ct-pace-catalog-number-b7950a-fda-510k.jpg K872526 - CT PACE CATALOG NUMBER B7950A K872526 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Sep 1987. https://www.510kdatabase.net/k872720/ 1987-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k872720-shiley-pts-chest-drainage-fda-510k.jpg K872720 - SHILEY PTS CHEST DRAINAGE AUTOTRANSFUSION SET K872720 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Sep 1987. https://www.510kdatabase.net/k872721/ 1987-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k872721-expanded-use-for-shiley-3l-cardiotomy-fda-510k.jpg K872721 - EXPANDED USE FOR SHILEY 3L CARDIOTOMY RESERVOIR K872721 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Sep 1987. https://www.510kdatabase.net/k872722/ 1987-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k872722-expanded-use-for-shiley-3l-cardf-plus-fda-510k.jpg K872722 - EXPANDED USE FOR SHILEY 3L CARDF PLUS K872722 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Sep 1987. https://www.510kdatabase.net/k873458/ 1987-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k873458-howmedica-pca-collared-femoral-stem-fda-510k.jpg K873458 - HOWMEDICA PCA COLLARED FEMORAL STEM K873458 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Sep 1987. https://www.510kdatabase.net/k873349/ 1987-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k873349-easy-test-emit-n-acetylprocainamide-fda-510k.jpg K873349 - EASY-TEST EMIT N-ACETYLPROCAINAMIDE NAPA #16649 K873349 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Sep 1987. https://www.510kdatabase.net/k873251/ 1987-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k873251-omnifit-bone-screw-fda-510k.jpg K873251 - OMNIFIT BONE SCREW K873251 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Sep 1987. https://www.510kdatabase.net/k872988/ 1987-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k872988-transigen-exudate-controlled-wound-fda-510k.jpg K872988 - TRANSIGEN EXUDATE CONTROLLED WOUND DRESSING K872988 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Sep 1987. https://www.510kdatabase.net/k873089/ 1987-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k873089-precision-hip-long-stem-femoral-fda-510k.jpg K873089 - PRECISION HIP LONG STEM FEMORAL COMPONENT SYSTEM K873089 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Sep 1987. https://www.510kdatabase.net/k873153/ 1987-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k873153-caulks-vps-cartridge-system-fda-510k.jpg K873153 - CAULK'S VPS CARTRIDGE SYSTEM K873153 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Sep 1987. https://www.510kdatabase.net/k872230/ 1987-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k872230-model-366-29-adaptaidtm-adapter-sleeve-fda-510k.jpg K872230 - MODEL 366-29 ADAPTAID(TM) ADAPTER SLEEVE K872230 is a FDA 510(k) cleared hematology medical device. Manufacturer: Intermedics, Inc.. Cleared Sep 1987. https://www.510kdatabase.net/k872790/ 1987-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k872790-perfusion-catheter-fda-510k.jpg K872790 - PERFUSION CATHETER K872790 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1987. https://www.510kdatabase.net/k872378/ 1987-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k872378-william-harvey-hardshell-venous-fda-510k.jpg K872378 - WILLIAM HARVEY HARDSHELL VENOUS RESERVOIR K872378 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Sep 1987. https://www.510kdatabase.net/k872392/ 1987-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k872392-aca-urine-drugs-of-abuse-calibrator-fda-510k.jpg K872392 - ACA URINE DRUGS OF ABUSE CALIBRATOR K872392 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Sep 1987. https://www.510kdatabase.net/k872646/ 1987-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k872646-virontm-fda-510k.jpg K872646 - VIRON(TM) K872646 is a FDA 510(k) cleared chemistry medical device. Manufacturer: bioMerieux, Inc.. Cleared Sep 1987. https://www.510kdatabase.net/k873052/ 1987-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k873052-stratusr-hlh-fluorometric-enzyme-fda-510k.jpg K873052 - STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY K873052 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Sep 1987. https://www.510kdatabase.net/k873424/ 1987-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k873424-easy-test-conjugated-bilirubin-cbil-fda-510k.jpg K873424 - EASY-TEST CONJUGATED BILIRUBIN (CBIL) #16690 K873424 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Sep 1987. https://www.510kdatabase.net/k872444/ 1987-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k872444-silux-plus-light-cured-restorative-fda-510k.jpg K872444 - SILUX PLUS LIGHT CURED RESTORATIVE MATERIAL K872444 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Sep 1987. https://www.510kdatabase.net/k873304/ 1987-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k873304-clinitek-auto-2000-reagent-cassette-fda-510k.jpg K873304 - CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES) K873304 is a FDA 510(k) cleared hematology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Sep 1987. https://www.510kdatabase.net/k872801/ 1987-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k872801-alleia-total-ige-eia-wmono-anti-ekie1-fda-510k.jpg K872801 - ALLEIA TOTAL IGE EIA W/MONO ANTI. EKIE1, 2, 5 K872801 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Sep 1987. https://www.510kdatabase.net/k872913/ 1987-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k872913-alleia-total-ige-irma-wmono-anti-rkie-fda-510k.jpg K872913 - ALLEIA TOTAL IGE IRMA W/MONO. ANTI. RKIE 1,2,5 K872913 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Sep 1987. https://www.510kdatabase.net/k872307/ 1987-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k872307-volumetric-package-stepper-fda-510k.jpg K872307 - VOLUMETRIC PACKAGE STEPPER H4222AA/CALCU. H4222AB K872307 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Sep 1987. https://www.510kdatabase.net/k873352/ 1987-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k873352-rapid-electrophoresis-system-rep-fda-510k.jpg K873352 - RAPID ELECTROPHORESIS SYSTEM (REP) K873352 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Sep 1987. https://www.510kdatabase.net/k870801/ 1987-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k870801-flo-gard-6200-volumetric-fda-510k.jpg K870801 - FLO-GARD 6200 VOLUMETRIC INFUSION/PUMPING BLOOD K870801 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Sep 1987. https://www.510kdatabase.net/k872759/ 1987-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k872759-aquatulle-fine-mesh-non-adhering-fda-510k.jpg K872759 - AQUATULLE FINE MESH NON-ADHERING DRESSING K872759 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Sep 1987. https://www.510kdatabase.net/k872820/ 1987-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k872820-safety-syringe-fda-510k.jpg K872820 - SAFETY SYRINGE K872820 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1987. https://www.510kdatabase.net/k871328/ 1987-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k871328-du-pont-legionella-urinary-antigen-ria-fda-510k.jpg K871328 - DU PONT LEGIONELLA URINARY ANTIGEN - RIA KIT K871328 is a FDA 510(k) cleared microbiology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Sep 1987. https://www.510kdatabase.net/k872789/ 1987-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k872789-paramax-urinecsf-calibrator-fda-510k.jpg K872789 - PARAMAX URINE/CSF CALIBRATOR K872789 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Sep 1987. https://www.510kdatabase.net/k873310/ 1987-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k873310-abbott-spectrumr-liquid-creatinine-fda-510k.jpg K873310 - ABBOTT SPECTRUM(R) LIQUID CREATININE REAGENT K873310 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1987. https://www.510kdatabase.net/k871349/ 1987-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k871349-howmedica-kinematic-ii-modular-tibial-fda-510k.jpg K871349 - HOWMEDICA KINEMATIC II MODULAR TIBIAL COMPONENT K871349 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Sep 1987. https://www.510kdatabase.net/k864223/ 1987-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k864223-iq-digoxin-fda-510k.jpg K864223 - IQ DIGOXIN K864223 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1987. https://www.510kdatabase.net/k872321/ 1987-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k872321-emds-salicylate-sal-calibrator-no-fda-510k.jpg K872321 - EMDS SALICYLATE (SAL) CALIBRATOR, NO# 67641/93 K872321 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Aug 1987. https://www.510kdatabase.net/k873049/ 1987-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k873049-triglycerides-gpo-without-free-glycerol-fda-510k.jpg K873049 - TRIGLYCERIDES GPO WITHOUT FREE GLYCEROL K873049 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Aug 1987. https://www.510kdatabase.net/k873103/ 1987-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k873103-technicon-h1-jrtm-system-fda-510k.jpg K873103 - TECHNICON H*1 JR.(TM) SYSTEM K873103 is a FDA 510(k) cleared hematology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Aug 1987. https://www.510kdatabase.net/k871110/ 1987-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k871110-coronary-artery-bypass-graft-cabg-marker-fda-510k.jpg K871110 - CORONARY ARTERY BYPASS GRAFT (CABG) MARKER K871110 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edward Weck, Inc.. Cleared Aug 1987. https://www.510kdatabase.net/k872454/ 1987-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k872454-biomet-modular-shoulder-prosthesis-fda-510k.jpg K872454 - BIOMET MODULAR SHOULDER PROSTHESIS K872454 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Aug 1987. https://www.510kdatabase.net/k873167/ 1987-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k873167-kodak-min-r-medium-screen-fda-510k.jpg K873167 - KODAK MIN-R MEDIUM SCREEN K873167 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Aug 1987. https://www.510kdatabase.net/k871846/ 1987-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k871846-flexiflo-toptainer-top-fill-enteral-fda-510k.jpg K871846 - FLEXIFLO TOPTAINER TOP-FILL ENTERAL NUTRIT. SYSTEM K871846 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1987. https://www.510kdatabase.net/k872296/ 1987-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k872296-bile-acids-reagent-fda-510k.jpg K872296 - BILE ACIDS REAGENT K872296 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Aug 1987. https://www.510kdatabase.net/k871499/ 1987-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k871499-protofluor-z-fda-510k.jpg K871499 - PROTOFLUOR Z K871499 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Helena Laboratories. Cleared Aug 1987. https://www.510kdatabase.net/k871978/ 1987-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k871978-codman-flexible-endoscope-fda-510k.jpg K871978 - CODMAN FLEXIBLE ENDOSCOPE K871978 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Aug 1987. https://www.510kdatabase.net/k873090/ 1987-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k873090-medium-199-no-m3274-whanks-salts-wol-fda-510k.jpg K873090 - MEDIUM 199 NO. M3274 W/HANKS' SALTS W.O/L-GLUTAMI. K873090 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Aug 1987. https://www.510kdatabase.net/k873091/ 1987-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k873091-ames-medium-no-a1420-wl-gluta-wosod-fda-510k.jpg K873091 - AMES' MEDIUM NO. A1420 W/L-GLUTA. W.O/SOD. BICARB. K873091 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Aug 1987. https://www.510kdatabase.net/k873092/ 1987-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k873092-rpmi-1640-medium-no-r7755-auto-modtm-fda-510k.jpg K873092 - RPMI-1640 MEDIUM NO. R7755 AUTO-MOD(TM) W.O/L-GLU. K873092 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Aug 1987. https://www.510kdatabase.net/k873093/ 1987-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k873093-mem-eagle-no-m3024-wearles-salts-fda-510k.jpg K873093 - (MEM) EAGLE NO. M3024 W/EARLE'S SALTS K873093 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Aug 1987. https://www.510kdatabase.net/k873094/ 1987-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k873094-mem-eagle-no-m7399-wearles-salts-fda-510k.jpg K873094 - (MEM) EAGLE NO. M7399 W/EARLE'S SALTS K873094 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Aug 1987. https://www.510kdatabase.net/k873095/ 1987-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k873095-mem-eagle-no-m3149-whanks-salts-fda-510k.jpg K873095 - (MEM) EAGLE NO. M3149 W/HANKS' SALTS K873095 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Aug 1987. https://www.510kdatabase.net/k873120/ 1987-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k873120-abbott-a-gent-iron-reagent-kit-fda-510k.jpg K873120 - ABBOTT A-GENT IRON REAGENT KIT K873120 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1987. https://www.510kdatabase.net/k873209/ 1987-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k873209-plaque-sweep-fda-510k.jpg K873209 - PLAQUE-SWEEP K873209 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Aug 1987. https://www.510kdatabase.net/k872493/ 1987-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k872493-directigen-1-2-3tm-group-a-strep-test-fda-510k.jpg K872493 - DIRECTIGEN 1-2-3(TM) GROUP A STREP TEST K872493 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1987. https://www.510kdatabase.net/k872776/ 1987-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k872776-profile-femoral-hip-prosthesis-wporocoat-fda-510k.jpg K872776 - PROFILE FEMORAL HIP PROSTHESIS W/POROCOAT K872776 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Aug 1987. https://www.510kdatabase.net/k872451/ 1987-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k872451-bile-acids-calibrator-fda-510k.jpg K872451 - BILE ACIDS CALIBRATOR K872451 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Aug 1987. https://www.510kdatabase.net/k872487/ 1987-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k872487-visionr-total-bilirubin-fda-510k.jpg K872487 - VISION(R) TOTAL BILIRUBIN K872487 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1987. https://www.510kdatabase.net/k872512/ 1987-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k872512-emds-total-bilirubin-tbil-testpacks-fda-510k.jpg K872512 - EMDS TOTAL BILIRUBIN (TBIL) TESTPACKS, #67675/95 K872512 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Aug 1987. https://www.510kdatabase.net/k872513/ 1987-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k872513-easy-test-total-bilirubin-tbil-item-no-fda-510k.jpg K872513 - EASY-TEST TOTAL BILIRUBIN (TBIL) ITEM NO. 16604 K872513 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Aug 1987. https://www.510kdatabase.net/k871996/ 1987-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k871996-abbott-biotell-pregnancy-test-fda-510k.jpg K871996 - ABBOTT BIOTELL PREGNANCY TEST K871996 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1987. https://www.510kdatabase.net/k872025/ 1987-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k872025-porocoat-r-proximal-femoral-third-fda-510k.jpg K872025 - POROCOAT (R) PROXIMAL FEMORAL THIRD PROSTHESIS K872025 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Aug 1987. https://www.510kdatabase.net/k872306/ 1987-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k872306-system-pack-for-bmdhitachi-704-chem-fda-510k.jpg K872306 - SYSTEM PACK FOR B.M.D/HITACHI 704 CHEM. ANA.(GABA) K872306 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Aug 1987. https://www.510kdatabase.net/k872027/ 1987-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k872027-olympus-gf-um2eu-m2-fda-510k.jpg K872027 - OLYMPUS GF-UM2/EU-M2 K872027 is a FDA 510(k) cleared radiology medical device. Manufacturer: Olympus Corp.. Cleared Aug 1987. https://www.510kdatabase.net/k872224/ 1987-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k872224-modified-trochanter-cable-grip-system-fda-510k.jpg K872224 - MODIFIED TROCHANTER CABLE GRIP SYSTEM K872224 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Aug 1987. https://www.510kdatabase.net/k872912/ 1987-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k872912-triglyceride-uv-reagent-fda-510k.jpg K872912 - TRIGLYCERIDE (UV) REAGENT K872912 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Aug 1987. https://www.510kdatabase.net/k872850/ 1987-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k872850-rate-infuser-system-fda-510k.jpg K872850 - RATE INFUSER SYSTEM K872850 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1987. https://www.510kdatabase.net/k872982/ 1987-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k872982-johnson-johnson-absorbent-occlusive-fda-510k.jpg K872982 - JOHNSON & JOHNSON ABSORBENT OCCLUSIVE DRESSING K872982 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Aug 1987. https://www.510kdatabase.net/k871265/ 1987-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k871265-analysttm-lipid-rotor-hdl-fda-510k.jpg K871265 - ANALYST(TM) LIPID ROTOR & HDL CALIBRATOR/CONTROL K871265 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Aug 1987. https://www.510kdatabase.net/k872175/ 1987-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k872175-tdxr-flecainide-fda-510k.jpg K872175 - TDXR FLECAINIDE K872175 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1987. https://www.510kdatabase.net/k872197/ 1987-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k872197-procedure-no-552553-bilirubin-total-fda-510k.jpg K872197 - PROCEDURE NO. 552/553 BILIRUBIN, TOTAL AND DIRECT K872197 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Aug 1987. https://www.510kdatabase.net/k872813/ 1987-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k872813-easy-st-analyzer-system-fda-510k.jpg K872813 - EASY ST ANALYZER SYSTEM K872813 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Aug 1987. https://www.510kdatabase.net/k870215/ 1987-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k870215-dotter-balloon-transluminal-angio-fda-510k.jpg K870215 - DOTTER BALLOON TRANSLUMINAL ANGIO. CATHETER (POLY) K870215 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Aug 1987. https://www.510kdatabase.net/k871422/ 1987-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k871422-olympus-angioscopy-pump-fda-510k.jpg K871422 - OLYMPUS ANGIOSCOPY PUMP K871422 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Olympus Corp.. Cleared Aug 1987. https://www.510kdatabase.net/k871859/ 1987-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k871859-ct9800-quick-3d-b7919da-fda-510k.jpg K871859 - CT9800 QUICK 3D #B7919DA K871859 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Aug 1987. https://www.510kdatabase.net/k871984/ 1987-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k871984-kodak-ektascan-image-trans-t1r1-p1-fda-510k.jpg K871984 - KODAK EKTASCAN IMAGE TRANS. T1/R1 & P1 SOFTWARE K871984 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Aug 1987. https://www.510kdatabase.net/k871994/ 1987-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k871994-ena-iii-test-kit-scl-70-autoantibody-fda-510k.jpg K871994 - ENA III TEST KIT (SCL-70 AUTOANTIBODY REAGENTS) K871994 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Aug 1987. https://www.510kdatabase.net/k872159/ 1987-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k872159-dideco-shiley-autotransfusion-fda-510k.jpg K872159 - DIDECO-SHILEY AUTOTRANSFUSION ACCESSORIES K872159 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Aug 1987. https://www.510kdatabase.net/k872161/ 1987-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k872161-dideco-shiley-preassembled-surgical-fda-510k.jpg K872161 - DIDECO-SHILEY PREASSEMBLED SURGICAL WASH SET K872161 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Aug 1987. https://www.510kdatabase.net/k872248/ 1987-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k872248-double-lumen-catheter-fda-510k.jpg K872248 - DOUBLE LUMEN CATHETER K872248 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Aug 1987. https://www.510kdatabase.net/k872800/ 1987-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k872800-tdx-immunoglobulin-g-diagnostic-kit-fda-510k.jpg K872800 - TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT K872800 is a FDA 510(k) cleared immunology medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1987. https://www.510kdatabase.net/k872834/ 1987-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k872834-titan-gel-ife-antiserum-to-igd-9409-fda-510k.jpg K872834 - TITAN GEL IFE ANTISERUM TO IGD-9409 & IGE-9410 K872834 is a FDA 510(k) cleared immunology medical device. Manufacturer: Helena Laboratories. Cleared Aug 1987. https://www.510kdatabase.net/k872943/ 1987-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k872943-disposable-articulator-fda-510k.jpg K872943 - DISPOSABLE ARTICULATOR K872943 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Aug 1987. https://www.510kdatabase.net/k870607/ 1987-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k870607-ssd-725-ultrasound-sector-scanner-fda-510k.jpg K870607 - SSD-725 ULTRASOUND SECTOR SCANNER K870607 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Aug 1987. https://www.510kdatabase.net/k871866/ 1987-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k871866-medtronic-classix-models-843684378438-fda-510k.jpg K871866 - MEDTRONIC CLASSIX MODELS 8436/8437/8438 K871866 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Aug 1987. https://www.510kdatabase.net/k872391/ 1987-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k872391-aca-du-pont-urine-opiates-u-opi-screen-fda-510k.jpg K872391 - ACA DU PONT URINE OPIATES (U OPI) SCREEN METHOD K872391 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Aug 1987. https://www.510kdatabase.net/k872878/ 1987-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k872878-tri-lock-modified-femoral-prosthesis-fda-510k.jpg K872878 - TRI-LOCK MODIFIED FEMORAL PROSTHESIS K872878 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Aug 1987. https://www.510kdatabase.net/k860688/ 1987-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k860688-monoject-pharmacy-tray-fda-510k.jpg K860688 - MONOJECT PHARMACY TRAY K860688 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Aug 1987. https://www.510kdatabase.net/k872195/ 1987-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k872195-data-fi-dimertest-latex-assay-fda-510k.jpg K872195 - DATA-FI DIMERTEST LATEX ASSAY K872195 is a FDA 510(k) cleared hematology medical device. Manufacturer: American Dade. Cleared Aug 1987. https://www.510kdatabase.net/k872782/ 1987-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k872782-bblr-gaspak-co2-pouchtm-fda-510k.jpg K872782 - BBL(R) GASPAK CO2 POUCH(TM) K872782 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1987. https://www.510kdatabase.net/k872844/ 1987-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k872844-thromborel-s-fda-510k.jpg K872844 - THROMBOREL S K872844 is a FDA 510(k) cleared hematology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Aug 1987. https://www.510kdatabase.net/k872903/ 1987-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k872903-microtrak-chlamydia-tracho-test-fda-510k.jpg K872903 - MICROTRAK CHLAMYDIA TRACHO. TEST - METHANOL FIXAT. K872903 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Syva Co.. Cleared Aug 1987. https://www.510kdatabase.net/k872532/ 1987-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k872532-auto-suture-stainless-steel-sutures-fda-510k.jpg K872532 - AUTO SUTURE STAINLESS STEEL SUTURES* K872532 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Aug 1987. https://www.510kdatabase.net/k872814/ 1987-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k872814-shiley-therapeutic-autotransfusion-fda-510k.jpg K872814 - SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM (REMOTE) K872814 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shiley, Inc.. Cleared Aug 1987. https://www.510kdatabase.net/k872634/ 1987-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k872634-cutter-pureflo-plus-iv-filter-fda-510k.jpg K872634 - CUTTER PUREFLO PLUS IV FILTER K872634 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Aug 1987. https://www.510kdatabase.net/k872735/ 1987-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k872735-howmedica-kinematic-iii-stabilizer-fda-510k.jpg K872735 - HOWMEDICA KINEMATIC III STABILIZER TOTAL KNEE SYS. K872735 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Aug 1987. https://www.510kdatabase.net/k872787/ 1987-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k872787-modified-curlcath-fda-510k.jpg K872787 - MODIFIED CURLCATH K872787 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Quinton, Inc.. Cleared Aug 1987. https://www.510kdatabase.net/k871844/ 1987-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k871844-argyle-vascular-bypass-set-fda-510k.jpg K871844 - ARGYLE VASCULAR BYPASS SET K871844 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sherwood Medical Co.. Cleared Aug 1987. https://www.510kdatabase.net/k872907/ 1987-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k872907-dentin-adhesive-fda-510k.jpg K872907 - DENTIN ADHESIVE K872907 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Aug 1987. https://www.510kdatabase.net/k872196/ 1987-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k872196-aqueous-blood-gaselectrolyte-contr-lev-fda-510k.jpg K872196 - AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III K872196 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Jul 1987. https://www.510kdatabase.net/k872758/ 1987-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k872758-theatre-gowns-fda-510k.jpg K872758 - THEATRE GOWNS K872758 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 1987. https://www.510kdatabase.net/k870817/ 1987-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k870817-mediport-ii-model-mp-dl-vascular-fda-510k.jpg K870817 - MEDIPORT II MODEL MP-DL VASCULAR ACCESS PORT K870817 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jul 1987. https://www.510kdatabase.net/k872184/ 1987-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k872184-tb-methylene-blue-fda-510k.jpg K872184 - TB METHYLENE BLUE K872184 is a FDA 510(k) cleared pathology medical device. Manufacturer: Remel Co.. Cleared Jul 1987. https://www.510kdatabase.net/k872185/ 1987-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k872185-light-green-fda-510k.jpg K872185 - LIGHT GREEN K872185 is a FDA 510(k) cleared pathology medical device. Manufacturer: Remel Co.. Cleared Jul 1987. https://www.510kdatabase.net/k872186/ 1987-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k872186-sulfuric-acid-10-fda-510k.jpg K872186 - SULFURIC ACID 10% K872186 is a FDA 510(k) cleared pathology medical device. Manufacturer: Remel Co.. Cleared Jul 1987. https://www.510kdatabase.net/k872187/ 1987-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k872187-tb-kinyoun-carbolfuchsin-fda-510k.jpg K872187 - TB KINYOUN CARBOLFUCHSIN K872187 is a FDA 510(k) cleared pathology medical device. Manufacturer: Remel Co.. Cleared Jul 1987. https://www.510kdatabase.net/k872189/ 1987-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k872189-methanol-absolute-fda-510k.jpg K872189 - METHANOL, ABSOLUTE K872189 is a FDA 510(k) cleared pathology medical device. Manufacturer: Remel Co.. Cleared Jul 1987. https://www.510kdatabase.net/k872624/ 1987-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k872624-intrasite-interactive-hydrocolloid-fda-510k.jpg K872624 - INTRASITE INTERACTIVE HYDROCOLLOID WOUND DRESSING K872624 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 1987. https://www.510kdatabase.net/k872757/ 1987-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k872757-opsite-speciality-drapes-fda-510k.jpg K872757 - OPSITE SPECIALITY DRAPES K872757 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 1987. https://www.510kdatabase.net/k871728/ 1987-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k871728-modified-lifecarer-4100-pca-infuser-fda-510k.jpg K871728 - MODIFIED LIFECARE(R) 4100 PCA INFUSER K871728 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Jul 1987. https://www.510kdatabase.net/k871908/ 1987-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k871908-iv-administration-set-fda-510k.jpg K871908 - IV ADMINISTRATION SET K871908 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Jul 1987. https://www.510kdatabase.net/k872320/ 1987-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k872320-easy-test-gamma-glutamyl-transferase-fda-510k.jpg K872320 - EASY-TEST GAMMA-GLUTAMYL TRANSFERASE (GGT) 16616 K872320 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jul 1987. https://www.510kdatabase.net/k872322/ 1987-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k872322-emds-gamma-glutamyl-transferase-ggt-fda-510k.jpg K872322 - EMDS GAMMA-GLUTAMYL TRANSFERASE (GGT) 67680/95 K872322 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jul 1987. https://www.510kdatabase.net/k872783/ 1987-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k872783-ampicillinsulbactam-20-mcg-sensi-disc-fda-510k.jpg K872783 - AMPICILLIN/SULBACTAM 20 MCG SENSI-DISC K872783 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jul 1987. https://www.510kdatabase.net/k871400/ 1987-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k871400-ssd-650-linear-convex-sector-fda-510k.jpg K871400 - SSD-650 LINEAR, CONVEX SECTOR, ULTRASOUND SCANNING K871400 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Jul 1987. https://www.510kdatabase.net/k872160/ 1987-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k872160-dideco-shiley-blood-separation-wash-bowl-fda-510k.jpg K872160 - DIDECO-SHILEY BLOOD SEPARATION WASH BOWL K872160 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shiley, Inc.. Cleared Jul 1987. https://www.510kdatabase.net/k872653/ 1987-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k872653-easy-test-hemoglobin-hgb-item-16685-fda-510k.jpg K872653 - EASY-TEST HEMOGLOBIN (HGB) ITEM #16685 K872653 is a FDA 510(k) cleared hematology medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jul 1987. https://www.510kdatabase.net/k870916/ 1987-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k870916-ssd-633-phased-array-sectorlinear-fda-510k.jpg K870916 - SSD-633 PHASED ARRAY SECTOR/LINEAR ULTRASOUND SYS. K870916 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Jul 1987. https://www.510kdatabase.net/k871585/ 1987-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k871585-modified-anatomic-modular-knee-amk-fda-510k.jpg K871585 - MODIFIED ANATOMIC MODULAR KNEE (AMK) SYSTEM K871585 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jul 1987. https://www.510kdatabase.net/k871722/ 1987-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k871722-medtenstm-model-number-7725-fda-510k.jpg K871722 - MEDTENS(TM), MODEL NUMBER 7725 K871722 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Jul 1987. https://www.510kdatabase.net/k871972/ 1987-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k871972-stratus-ige-fluorometric-enzyme-fda-510k.jpg K871972 - STRATUS IGE FLUOROMETRIC ENZYME IMMUNOASSAY K871972 is a FDA 510(k) cleared immunology medical device. Manufacturer: American Dade. Cleared Jul 1987. https://www.510kdatabase.net/k872019/ 1987-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k872019-bi-articular-ii-hip-device-fda-510k.jpg K872019 - BI-ARTICULAR II HIP DEVICE K872019 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jul 1987. https://www.510kdatabase.net/k872158/ 1987-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k872158-dideco-shiley-waste-collection-bag-fda-510k.jpg K872158 - DIDECO-SHILEY WASTE COLLECTION BAG K872158 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shiley, Inc.. Cleared Jul 1987. https://www.510kdatabase.net/k872162/ 1987-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k872162-dideco-shiley-blood-reinfusion-bag-fda-510k.jpg K872162 - DIDECO-SHILEY BLOOD REINFUSION BAG K872162 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shiley, Inc.. Cleared Jul 1987. https://www.510kdatabase.net/k872246/ 1987-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k872246-modified-model-9431-teletrace-fda-510k.jpg K872246 - MODIFIED MODEL 9431 TELETRACE TRANSMITTER K872246 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jul 1987. https://www.510kdatabase.net/k872397/ 1987-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k872397-cobas-fp-reagents-for-pheno-cobas-fp-fda-510k.jpg K872397 - COBAS FP REAGENTS FOR PHENO & COBAS FP PHENO CALI. K872397 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jul 1987. https://www.510kdatabase.net/k863488/ 1987-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k863488-enzygnost-anti-cmv-igg-test-fda-510k.jpg K863488 - ENZYGNOST ANTI-CMV IGG TEST K863488 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Jul 1987. https://www.510kdatabase.net/k871593/ 1987-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k871593-tdxr-fetal-lung-maturity-fda-510k.jpg K871593 - TDXR FETAL LUNG MATURITY K871593 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jul 1987. https://www.510kdatabase.net/k871523/ 1987-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k871523-respironics-sanders-bipapeasy-fda-510k.jpg K871523 - RESPIRONICS SANDERS BIPAPEASY K871523 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Jul 1987. https://www.510kdatabase.net/k872130/ 1987-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k872130-accupoint-hcg-pregnancy-test-and-fda-510k.jpg K872130 - ACCUPOINT HCG PREGNANCY TEST AND ACCESSORIES K872130 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Jul 1987. https://www.510kdatabase.net/k872295/ 1987-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k872295-cholesterol-reagent-fda-510k.jpg K872295 - CHOLESTEROL REAGENT K872295 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Jul 1987. https://www.510kdatabase.net/k872575/ 1987-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k872575-hdl-cholesterol-reagent-fda-510k.jpg K872575 - HDL CHOLESTEROL REAGENT K872575 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Jul 1987. https://www.510kdatabase.net/k871700/ 1987-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k871700-hcg-mab-solid-phase-component-system-fda-510k.jpg K871700 - HCG MAB SOLID PHASE COMPONENT SYSTEM K871700 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jul 1987. https://www.510kdatabase.net/k871745/ 1987-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k871745-model-26021c-bipolar-coagulator-fda-510k.jpg K871745 - MODEL 26021C BIPOLAR COAGULATOR K871745 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jul 1987. https://www.510kdatabase.net/k864912/ 1987-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k864912-pds-polydioxanon-absorbable-pin-fda-510k.jpg K864912 - PDS (POLYDIOXANON) ABSORBABLE PIN K864912 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jul 1987. https://www.510kdatabase.net/k865083/ 1987-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k865083-affinitytm-i-uptake-immunittm-fda-510k.jpg K865083 - AFFINITY(TM) I UPTAKE IMMUNIT(TM) K865083 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jul 1987. https://www.510kdatabase.net/k871977/ 1987-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k871977-dade-moni-trol-chemistry-fda-510k.jpg K871977 - DADE MONI-TROL CHEMISTRY CONTROL/CALIBRATOR K871977 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Jul 1987. https://www.510kdatabase.net/k872311/ 1987-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k872311-abbott-a-gent-liquid-magnesium-reagent-fda-510k.jpg K872311 - ABBOTT A-GENT LIQUID MAGNESIUM REAGENT K872311 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jul 1987. https://www.510kdatabase.net/k872330/ 1987-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k872330-emds-salicylate-sal-testpacks-item-no-fda-510k.jpg K872330 - EMDS SALICYLATE (SAL) TESTPACKS, ITEM NO. 67694/95 K872330 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jul 1987. https://www.510kdatabase.net/k872377/ 1987-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k872377-chrom-trol-fda-510k.jpg K872377 - CHROM-TROL K872377 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Jul 1987. https://www.510kdatabase.net/k872494/ 1987-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k872494-hitachi-717-chemistry-analyzer-fda-510k.jpg K872494 - HITACHI 717 CHEMISTRY ANALYZER K872494 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jul 1987. https://www.510kdatabase.net/k872050/ 1987-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k872050-paramax-cholesterol-reagent-fda-510k.jpg K872050 - PARAMAX CHOLESTEROL REAGENT K872050 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Jul 1987. https://www.510kdatabase.net/k872328/ 1987-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k872328-digoxin-fpia-calibrators-fda-510k.jpg K872328 - DIGOXIN FPIA CALIBRATORS K872328 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Jul 1987. https://www.510kdatabase.net/k872347/ 1987-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k872347-digoxin-fpia-controls-fda-510k.jpg K872347 - DIGOXIN FPIA CONTROLS K872347 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Jul 1987. https://www.510kdatabase.net/k865010/ 1987-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k865010-micor-fda-510k.jpg K865010 - MICOR K865010 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 1987. https://www.510kdatabase.net/k871388/ 1987-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k871388-micromat-model-415-bichromatic-filter-fda-510k.jpg K871388 - MICROMAT MODEL 415 - BICHROMATIC FILTER PHOTOMETER K871388 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bio-Rad. Cleared Jul 1987. https://www.510kdatabase.net/k872227/ 1987-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k872227-liquichek-pediatric-control-levels-i-fda-510k.jpg K872227 - LIQUICHEK PEDIATRIC CONTROL LEVELS I AND II K872227 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Jul 1987. https://www.510kdatabase.net/k872360/ 1987-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k872360-data-fi-fibrinogen-degradation-fda-510k.jpg K872360 - DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET K872360 is a FDA 510(k) cleared hematology medical device. Manufacturer: American Dade. Cleared Jul 1987. https://www.510kdatabase.net/k872251/ 1987-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k872251-abrasive-disc-polishing-wheel-fda-510k.jpg K872251 - ABRASIVE DISC - POLISHING WHEEL K872251 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jul 1987. https://www.510kdatabase.net/k872279/ 1987-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k872279-scotchbond-2-adhesive-wscotchprep-fda-510k.jpg K872279 - SCOTCHBOND 2 ADHESIVE W/SCOTCHPREP DENTIN PRIMER K872279 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Jul 1987. https://www.510kdatabase.net/k870821/ 1987-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k870821-polytron-models-1001-1002-and-1004-fda-510k.jpg K870821 - POLYTRON MODELS 1001, 1002 AND 1004 K870821 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 1987. https://www.510kdatabase.net/k871567/ 1987-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k871567-phenytoin-fpia-controls-fda-510k.jpg K871567 - PHENYTOIN FPIA CONTROLS K871567 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Jul 1987. https://www.510kdatabase.net/k872110/ 1987-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k872110-easy-test-ammonia-amon-item-no-16695-fda-510k.jpg K872110 - EASY-TEST AMMONIA (AMON) ITEM NO. 16695 K872110 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jul 1987. https://www.510kdatabase.net/k872305/ 1987-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k872305-irma-count-tsh-rkts1-rkts2-rkts5-rktsx-fda-510k.jpg K872305 - IRMA-COUNT TSH RKTS1, RKTS2, RKTS5, RKTSX K872305 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jul 1987. https://www.510kdatabase.net/k871814/ 1987-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k871814-sarmiento-forearm-nail-fda-510k.jpg K871814 - SARMIENTO FOREARM NAIL K871814 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jun 1987. https://www.510kdatabase.net/k870214/ 1987-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k870214-modified-saltex-reagent-strips-fda-510k.jpg K870214 - MODIFIED SALTEX REAGENT STRIPS K870214 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Jun 1987. https://www.510kdatabase.net/k872223/ 1987-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k872223-modified-omega-compression-hip-screw-fda-510k.jpg K872223 - MODIFIED OMEGA COMPRESSION HIP SCREW SYSTEM K872223 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jun 1987. https://www.510kdatabase.net/k872084/ 1987-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k872084-porocoat-mark-ii-total-elbow-fda-510k.jpg K872084 - POROCOAT MARK II TOTAL ELBOW K872084 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jun 1987. https://www.510kdatabase.net/k872188/ 1987-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k872188-macconkey-wsorbitol-fda-510k.jpg K872188 - MACCONKEY W/SORBITOL K872188 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Jun 1987. https://www.510kdatabase.net/k871857/ 1987-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k871857-hps-ii-calcar-femoral-prosthesis-fda-510k.jpg K871857 - HPS II CALCAR FEMORAL PROSTHESIS K871857 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jun 1987. https://www.510kdatabase.net/k871872/ 1987-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k871872-hi-marc-interlocking-nail-fda-510k.jpg K871872 - HI MARC INTERLOCKING NAIL K871872 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jun 1987. https://www.510kdatabase.net/k872105/ 1987-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k872105-kodak-ektachem-700xr-analyzer-fda-510k.jpg K872105 - KODAK EKTACHEM 700XR ANALYZER K872105 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Jun 1987. https://www.510kdatabase.net/k872171/ 1987-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k872171-periotest-fda-510k.jpg K872171 - PERIOTEST K872171 is a FDA 510(k) cleared dental medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 1987. https://www.510kdatabase.net/k871624/ 1987-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k871624-thora-drainr-abt-system-fda-510k.jpg K871624 - THORA-DRAIN(R) ABT SYSTEM K871624 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sherwood Medical Co.. Cleared Jun 1987. https://www.510kdatabase.net/k872061/ 1987-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k872061-lp-lateral-fluoro-positioner-b5077a-fda-510k.jpg K872061 - LP LATERAL FLUORO POSITIONER (B5077A) K872061 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jun 1987. https://www.510kdatabase.net/k872193/ 1987-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k872193-fletchers-medium-fletchers-medium-w5-fu-fda-510k.jpg K872193 - FLETCHER'S MEDIUM & FLETCHER'S MEDIUM W/5-FU K872193 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jun 1987. https://www.510kdatabase.net/k872210/ 1987-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k872210-impression-tray-fda-510k.jpg K872210 - IMPRESSION TRAY K872210 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jun 1987. https://www.510kdatabase.net/k871827/ 1987-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k871827-omega-iii-angiographic-table-rotation-fda-510k.jpg K871827 - OMEGA III ANGIOGRAPHIC TABLE, ROTATION & STEPPER K871827 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jun 1987. https://www.510kdatabase.net/k872245/ 1987-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k872245-proview-e7015-prolink-image-display-fda-510k.jpg K872245 - PROVIEW (E7015) & PROLINK IMAGE DISPLAY SYSTEM K872245 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jun 1987. https://www.510kdatabase.net/k870400/ 1987-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k870400-scx-information-management-system-fda-510k.jpg K870400 - SCX INFORMATION MANAGEMENT SYSTEM K870400 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jun 1987. https://www.510kdatabase.net/k871254/ 1987-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k871254-acculevel-carbamazepine-test-fda-510k.jpg K871254 - ACCULEVEL CARBAMAZEPINE TEST K871254 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jun 1987. https://www.510kdatabase.net/k871589/ 1987-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k871589-theophylline-fpia-controls-fda-510k.jpg K871589 - THEOPHYLLINE FPIA CONTROLS K871589 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Sigma Chemical Co.. Cleared Jun 1987. https://www.510kdatabase.net/k871749/ 1987-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k871749-adult-perm-cath-40cm-fda-510k.jpg K871749 - ADULT PERM-CATH 40CM. K871749 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quinton, Inc.. Cleared Jun 1987. https://www.510kdatabase.net/k871831/ 1987-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k871831-patho-dx-latex-agglutination-strep-fda-510k.jpg K871831 - PATHO DX LATEX AGGLUTINATION STREP GROUPING KIT K871831 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jun 1987. https://www.510kdatabase.net/k871892/ 1987-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k871892-technicon-rar-systems-assistr-clin-fda-510k.jpg K871892 - TECHNICON RA(R) SYSTEMS & ASSIST(R) CLIN. ANALYZER K871892 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Jun 1987. https://www.510kdatabase.net/k871942/ 1987-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k871942-perm-cath-catheter-kit-fda-510k.jpg K871942 - PERM-CATH CATHETER KIT K871942 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quinton, Inc.. Cleared Jun 1987. https://www.510kdatabase.net/k872103/ 1987-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k872103-kodak-ektachem-700s-analyzer-fda-510k.jpg K872103 - KODAK EKTACHEM 700S ANALYZER K872103 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Jun 1987. https://www.510kdatabase.net/k872104/ 1987-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k872104-kodak-ektachem-700p-analyzer-fda-510k.jpg K872104 - KODAK EKTACHEM 700P ANALYZER K872104 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Jun 1987. https://www.510kdatabase.net/k872108/ 1987-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k872108-abbott-spectrum-bicarbonate-reagent-kit-fda-510k.jpg K872108 - ABBOTT SPECTRUM BICARBONATE REAGENT KIT K872108 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1987. https://www.510kdatabase.net/k871166/ 1987-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k871166-allevyn-hydrophilic-polyurethane-fda-510k.jpg K871166 - ALLEVYN HYDROPHILIC POLYURETHANE DRESSING K871166 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jun 1987. https://www.510kdatabase.net/k870719/ 1987-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k870719-sensir-system-fda-510k.jpg K870719 - SENSIR SYSTEM K870719 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jun 1987. https://www.510kdatabase.net/k871596/ 1987-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k871596-ionescu-shiley-pericardial-xenograft-isu-fda-510k.jpg K871596 - IONESCU-SHILEY PERICARDIAL XENOGRAFT (ISU) K871596 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Jun 1987. https://www.510kdatabase.net/k871895/ 1987-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k871895-tina-quant-a-crp-fda-510k.jpg K871895 - TINA-QUANT [A] CRP K871895 is a FDA 510(k) cleared immunology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jun 1987. https://www.510kdatabase.net/k871896/ 1987-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k871896-tina-quant-a-transferrin-fda-510k.jpg K871896 - TINA-QUANT [A] TRANSFERRIN K871896 is a FDA 510(k) cleared immunology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jun 1987. https://www.510kdatabase.net/k871152/ 1987-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k871152-sigmas-calcium-procedure-no-587-fda-510k.jpg K871152 - SIGMA'S CALCIUM PROCEDURE NO. 587 K871152 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Jun 1987. https://www.510kdatabase.net/k871471/ 1987-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k871471-capillary-flow-dialyzers-models-st-12-fda-510k.jpg K871471 - CAPILLARY FLOW DIALYZERS MODELS ST-12 & ST-15 K871471 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Jun 1987. https://www.510kdatabase.net/k871423/ 1987-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k871423-phenytoin-fpia-calibrators-fda-510k.jpg K871423 - PHENYTOIN FPIA CALIBRATORS K871423 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Jun 1987. https://www.510kdatabase.net/k871645/ 1987-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k871645-tdxr-reatm-ethanol-fda-510k.jpg K871645 - TDXR REA(TM) ETHANOL K871645 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1987. https://www.510kdatabase.net/k871973/ 1987-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k871973-il-monarch-1000-clinical-chemistry-fda-510k.jpg K871973 - IL MONARCH 1000 CLINICAL CHEMISTRY ANALYTICAL SYS. K871973 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jun 1987. https://www.510kdatabase.net/k871318/ 1987-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k871318-qic-bleeding-time-device-fda-510k.jpg K871318 - Q.I.C. BLEEDING TIME DEVICE K871318 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Jun 1987. https://www.510kdatabase.net/k871680/ 1987-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k871680-modified-cobas-fp-reagents-for-napa-fda-510k.jpg K871680 - MODIFIED COBAS FP REAGENTS FOR NAPA AND CALIBRATOR K871680 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jun 1987. https://www.510kdatabase.net/k871885/ 1987-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k871885-eska-herrmann-tracheostomy-valve-fda-510k.jpg K871885 - ESKA-HERRMANN TRACHEOSTOMY VALVE K871885 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jun 1987. https://www.510kdatabase.net/k870460/ 1987-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k870460-dorrostm-small-vessel-pta-catheter-fda-510k.jpg K870460 - DORROS(TM) SMALL VESSEL PTA CATHETER K870460 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jun 1987. https://www.510kdatabase.net/k871363/ 1987-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k871363-model-420-system-measurement-blood-fda-510k.jpg K871363 - MODEL 420 SYSTEM MEASUREMENT, BLOOD PRESSURE K871363 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Jun 1987. https://www.510kdatabase.net/k871390/ 1987-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k871390-bard-biopty-biopsy-system-fda-510k.jpg K871390 - BARD BIOPTY BIOPSY SYSTEM K871390 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jun 1987. https://www.510kdatabase.net/k871621/ 1987-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k871621-the-karl-storz-model-28805-arthro-pump-fda-510k.jpg K871621 - THE KARL STORZ MODEL 28805 ARTHRO PUMP K871621 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jun 1987. https://www.510kdatabase.net/k871695/ 1987-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k871695-double-antibody-cannabinoids-kthd1-and-fda-510k.jpg K871695 - DOUBLE ANTIBODY CANNABINOIDS KTHD1 AND KTHD5 K871695 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jun 1987. https://www.510kdatabase.net/k871696/ 1987-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k871696-double-antibody-amphetamine-kapd1-and-fda-510k.jpg K871696 - DOUBLE ANTIBODY AMPHETAMINE KAPD1 AND KAPD5 K871696 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jun 1987. https://www.510kdatabase.net/k871717/ 1987-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k871717-model-28200c-micro-arthroplasty-system-fda-510k.jpg K871717 - MODEL 28200C MICRO-ARTHROPLASTY SYSTEM K871717 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jun 1987. https://www.510kdatabase.net/k871891/ 1987-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k871891-karl-storz-model-28184-pneumatic-fda-510k.jpg K871891 - KARL STORZ MODEL 28184 PNEUMATIC SHUTTLE SHAVER K871891 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jun 1987. https://www.510kdatabase.net/k871937/ 1987-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k871937-impression-syringe-fda-510k.jpg K871937 - IMPRESSION SYRINGE K871937 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jun 1987. https://www.510kdatabase.net/k871219/ 1987-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k871219-titanodont-subcortical-implant-with-fda-510k.jpg K871219 - TITANODONT SUBCORTICAL IMPLANT WITH POROCOAT K871219 is a FDA 510(k) cleared dental medical device. Manufacturer: Depuy, Inc.. Cleared Jun 1987. https://www.510kdatabase.net/k871772/ 1987-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k871772-kinematic-iii-post-cruciate-total-fda-510k.jpg K871772 - KINEMATIC III POST CRUCIATE TOTAL CONDYLAR KNEE SY K871772 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jun 1987. https://www.510kdatabase.net/k871943/ 1987-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k871943-dat-tm-amylase-reagent-fda-510k.jpg K871943 - D.A.T. (TM) AMYLASE REAGENT K871943 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Jun 1987. https://www.510kdatabase.net/k871769/ 1987-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k871769-omnifitr-total-knee-system-modification-fda-510k.jpg K871769 - OMNIFIT(R) TOTAL KNEE SYSTEM (MODIFICATION) K871769 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Jun 1987. https://www.510kdatabase.net/k872020/ 1987-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k872020-mucate-agar-slants-and-mucate-broth-fda-510k.jpg K872020 - MUCATE AGAR, SLANTS AND MUCATE BROTH K872020 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jun 1987. https://www.510kdatabase.net/k870890/ 1987-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k870890-alkaline-phosphatase-indolyl-blue-fda-510k.jpg K870890 - ALKALINE PHOSPHATASE INDOLYL BLUE REAGENT K870890 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Jun 1987. https://www.510kdatabase.net/k871394/ 1987-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k871394-theophylline-fpia-calibrators-fda-510k.jpg K871394 - THEOPHYLLINE FPIA CALIBRATORS K871394 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Jun 1987. https://www.510kdatabase.net/k870235/ 1987-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k870235-omnifit-ii-hip-prostheses-cement-fda-510k.jpg K870235 - OMNIFIT II HIP PROSTHESES: CEMENT FIXATION K870235 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared May 1987. https://www.510kdatabase.net/k871295/ 1987-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k871295-adaptalite-porcelain-veneer-fda-510k.jpg K871295 - ADAPTALITE* PORCELAIN VENEER CEMENTATION SYSTEM K871295 is a FDA 510(k) cleared dental medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared May 1987. https://www.510kdatabase.net/k871860/ 1987-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k871860-novapath-c-trachomatis-direct-spec-fda-510k.jpg K871860 - NOVAPATH C. TRACHOMATIS DIRECT SPEC COLLECTION KIT K871860 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bio-Rad. Cleared May 1987. https://www.510kdatabase.net/k870627/ 1987-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k870627-affinity-tm-hcg-immunit-tm-fda-510k.jpg K870627 - AFFINITY (TM) HCG IMMUNIT (TM) K870627 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared May 1987. https://www.510kdatabase.net/k871484/ 1987-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k871484-cobas-fp-reagents-for-theophylline-fda-510k.jpg K871484 - COBAS FP REAGENTS FOR THEOPHYLLINE & CALIBRATORS K871484 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared May 1987. https://www.510kdatabase.net/k871907/ 1987-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k871907-ld-presumpto-quad-fda-510k.jpg K871907 - LD PRESUMPTO QUAD K871907 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared May 1987. https://www.510kdatabase.net/k871510/ 1987-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k871510-modified-profile-hip-pmma-cement-spacer-fda-510k.jpg K871510 - MODIFIED PROFILE HIP PMMA CEMENT SPACER K871510 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared May 1987. https://www.510kdatabase.net/k871909/ 1987-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k871909-composite-restorative-carrier-fda-510k.jpg K871909 - COMPOSITE RESTORATIVE CARRIER K871909 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared May 1987. https://www.510kdatabase.net/k870998/ 1987-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k870998-technicon-ra-xttm-system-immunoassays-fda-510k.jpg K870998 - TECHNICON RA-XT(TM) SYSTEM IMMUNOASSAYS K870998 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared May 1987. https://www.510kdatabase.net/k871150/ 1987-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k871150-astratm-systems-triglycerides-fda-510k.jpg K871150 - ASTRA(TM) SYSTEMS TRIGLYCERIDES CALIBRATOR 8 K871150 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared May 1987. https://www.510kdatabase.net/k871307/ 1987-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k871307-syva-q-spec-photometer-fda-510k.jpg K871307 - SYVA Q-SPEC PHOTOMETER K871307 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared May 1987. https://www.510kdatabase.net/k871811/ 1987-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k871811-system-reagents-hitachi-737-calcium-edta-fda-510k.jpg K871811 - SYSTEM REAGENTS HITACHI 737 CALCIUM (EDTA) K871811 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared May 1987. https://www.510kdatabase.net/k871838/ 1987-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k871838-biomek-1000c-automated-laboratory-work-fda-510k.jpg K871838 - BIOMEK 1000C AUTOMATED LABORATORY WORK STATION K871838 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared May 1987. https://www.510kdatabase.net/k871580/ 1987-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k871580-implantable-pacing-lead-models-487-06-fda-510k.jpg K871580 - IMPLANTABLE PACING LEAD MODELS 487-06 TO 430-01 K871580 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared May 1987. https://www.510kdatabase.net/k870357/ 1987-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k870357-electrode-pacemaker-permanent-temporary-fda-510k.jpg K870357 - ELECTRODE, PACEMAKER, PERMANENT & TEMPORARY K870357 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared May 1987. https://www.510kdatabase.net/k871476/ 1987-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k871476-silver-stain-reagent-system-fda-510k.jpg K871476 - SILVER STAIN REAGENT SYSTEM K871476 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared May 1987. https://www.510kdatabase.net/k871625/ 1987-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k871625-model-366-12-adaptaid-tm-step-down-fda-510k.jpg K871625 - MODEL 366-12 ADAPTAID (TM) STEP-DOWN ADAPTER K871625 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared May 1987. https://www.510kdatabase.net/k871786/ 1987-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k871786-gbna-medium-fda-510k.jpg K871786 - GBNA MEDIUM K871786 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared May 1987. https://www.510kdatabase.net/k870739/ 1987-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k870739-abbott-testpack-hcg-combo-fda-510k.jpg K870739 - ABBOTT TESTPACK HCG COMBO K870739 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared May 1987. https://www.510kdatabase.net/k871701/ 1987-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k871701-arylsulfatase-broth-fda-510k.jpg K871701 - ARYLSULFATASE BROTH K871701 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared May 1987. https://www.510kdatabase.net/k871702/ 1987-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k871702-mrs-agar-and-mrs-broth-fda-510k.jpg K871702 - MRS AGAR AND MRS BROTH K871702 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared May 1987. https://www.510kdatabase.net/k870782/ 1987-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k870782-cyclo-brush-fda-510k.jpg K870782 - CYCLO-BRUSH K870782 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Medline Industries, Inc.. Cleared May 1987. https://www.510kdatabase.net/k871730/ 1987-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k871730-modified-use-of-pull-apart-introducer-fda-510k.jpg K871730 - MODIFIED USE OF PULL-APART INTRODUCER SET K871730 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quinton, Inc.. Cleared May 1987. https://www.510kdatabase.net/k871024/ 1987-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k871024-precimatr-c3-fda-510k.jpg K871024 - PRECIMAT(R) C3 K871024 is a FDA 510(k) cleared immunology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared May 1987. https://www.510kdatabase.net/k871027/ 1987-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k871027-precinormr-protein-fda-510k.jpg K871027 - PRECINORM(R) PROTEIN K871027 is a FDA 510(k) cleared immunology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared May 1987. https://www.510kdatabase.net/k870181/ 1987-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k870181-johnson-intratracheal-oxygen-catheter-fda-510k.jpg K870181 - JOHNSON INTRATRACHEAL OXYGEN CATHETER SET K870181 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Cook, Inc.. Cleared May 1987. https://www.510kdatabase.net/k870652/ 1987-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k870652-medtronic-model-4220-ambulatory-ecg-fda-510k.jpg K870652 - MEDTRONIC MODEL 4220 AMBULATORY ECG MONITOR K870652 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared May 1987. https://www.510kdatabase.net/k871022/ 1987-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k871022-precimatr-transferrin-fda-510k.jpg K871022 - PRECIMAT(R) TRANSFERRIN K871022 is a FDA 510(k) cleared immunology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared May 1987. https://www.510kdatabase.net/k871023/ 1987-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k871023-precimatr-c4-fda-510k.jpg K871023 - PRECIMAT(R) C4 K871023 is a FDA 510(k) cleared immunology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared May 1987. https://www.510kdatabase.net/k871461/ 1987-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k871461-vision-tm-hdl-cholesterol-fda-510k.jpg K871461 - VISION (TM) HDL CHOLESTEROL K871461 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared May 1987. https://www.510kdatabase.net/k871240/ 1987-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k871240-abbott-a-gent-ld-1-isozyme-reagent-fda-510k.jpg K871240 - ABBOTT A-GENT LD-1 ISOZYME REAGENT K871240 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared May 1987. https://www.510kdatabase.net/k871447/ 1987-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k871447-todd-hewitt-wcna-lim-broth-fda-510k.jpg K871447 - TODD HEWITT W/CNA (LIM BROTH) K871447 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared May 1987. https://www.510kdatabase.net/k871640/ 1987-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k871640-alkaline-peptone-water-fda-510k.jpg K871640 - ALKALINE PEPTONE WATER K871640 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared May 1987. https://www.510kdatabase.net/k870035/ 1987-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k870035-kodak-ektachem-dt-slides-ca-fda-510k.jpg K870035 - KODAK EKTACHEM DT SLIDES (CA) K870035 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared May 1987. https://www.510kdatabase.net/k871329/ 1987-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k871329-easy-test-emit-gentamicin-gent-item-no-fda-510k.jpg K871329 - EASY-TEST EMIT GENTAMICIN (GENT) ITEM NO. 16640 K871329 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared May 1987. https://www.510kdatabase.net/k871638/ 1987-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k871638-easy-test-chem-cal-levels-123items-fda-510k.jpg K871638 - EASY-TEST CHEM CAL LEVELS 1,2&3/ITEMS 67617 ABC/95 K871638 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared May 1987. https://www.510kdatabase.net/k870328/ 1987-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k870328-single-lumen-acute-catheter-fda-510k.jpg K870328 - SINGLE LUMEN ACUTE CATHETER K870328 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quinton, Inc.. Cleared May 1987. https://www.510kdatabase.net/k871435/ 1987-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k871435-bard-ems-system-6000-esu-fda-510k.jpg K871435 - BARD EMS SYSTEM 6000 E.S.U. K871435 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 1987. https://www.510kdatabase.net/k871664/ 1987-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k871664-iron-magnesium-additionsreferril-b-fda-510k.jpg K871664 - IRON & MAGNESIUM ADDITIONS/REFERRIL B CALIBRATOR K871664 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared May 1987. https://www.510kdatabase.net/k864575/ 1987-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k864575-mingograf-740-model-91-54-634-fda-510k.jpg K864575 - MINGOGRAF 740 - MODEL #91-54-634 K864575 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 1987. https://www.510kdatabase.net/k871055/ 1987-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k871055-precimatr-crp-fda-510k.jpg K871055 - PRECIMAT(R) CRP K871055 is a FDA 510(k) cleared immunology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared May 1987. https://www.510kdatabase.net/k871333/ 1987-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k871333-implantable-tined-trans-pacing-fda-510k.jpg K871333 - IMPLANTABLE TINED, TRANS. PACING LEAD/REVIS. LABEL K871333 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared May 1987. https://www.510kdatabase.net/k864226/ 1987-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k864226-johnson-johnson-staining-removing-fda-510k.jpg K864226 - JOHNSON & JOHNSON STAINING REMOVING COMPOUND K864226 is a FDA 510(k) cleared dental medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared May 1987. https://www.510kdatabase.net/k870699/ 1987-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k870699-standard-porocoat-modified-medial-fda-510k.jpg K870699 - STANDARD POROCOAT MODIFIED MEDIAL ASPECT AML HIP K870699 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared May 1987. https://www.510kdatabase.net/k864842/ 1987-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k864842-chlamydiazyme-diagnostic-kit-fda-510k.jpg K864842 - CHLAMYDIAZYME DIAGNOSTIC KIT K864842 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1987. https://www.510kdatabase.net/k870958/ 1987-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k870958-titan-gel-multi-slot-sp-17-kit-cat-no-fda-510k.jpg K870958 - TITAN GEL MULTI-SLOT SP-17 KIT CAT. NO. 3091 K870958 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Apr 1987. https://www.510kdatabase.net/k871360/ 1987-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k871360-10f-115f-mahurkar-dual-lumen-catheters-fda-510k.jpg K871360 - 10F & 11.5F MAHURKAR DUAL LUMEN CATHETERS, USEABLE K871360 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quinton, Inc.. Cleared Apr 1987. https://www.510kdatabase.net/k871477/ 1987-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k871477-neutral-red-fda-510k.jpg K871477 - NEUTRAL RED K871477 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Apr 1987. https://www.510kdatabase.net/k871498/ 1987-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k871498-titan-gel-immunofix-controls-fda-510k.jpg K871498 - TITAN GEL IMMUNOFIX CONTROLS K871498 is a FDA 510(k) cleared immunology medical device. Manufacturer: Helena Laboratories. Cleared Apr 1987. https://www.510kdatabase.net/k871532/ 1987-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k871532-tomtec-gram-stainer-crystal-violet-fda-510k.jpg K871532 - TOMTEC GRAM STAINER CRYSTAL VIOLET K871532 is a FDA 510(k) cleared pathology medical device. Manufacturer: Remel Co.. Cleared Apr 1987. https://www.510kdatabase.net/k871533/ 1987-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k871533-tomtec-gram-stainer-decolorizer-fda-510k.jpg K871533 - TOMTEC GRAM STAINER DECOLORIZER K871533 is a FDA 510(k) cleared pathology medical device. Manufacturer: Remel Co.. Cleared Apr 1987. https://www.510kdatabase.net/k871544/ 1987-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k871544-methyl-green-solution-fda-510k.jpg K871544 - METHYL GREEN SOLUTION K871544 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Apr 1987. https://www.510kdatabase.net/k871545/ 1987-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k871545-new-fuchsin-solution-fda-510k.jpg K871545 - NEW FUCHSIN SOLUTION K871545 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Apr 1987. https://www.510kdatabase.net/k870075/ 1987-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k870075-central-venous-catheter-fda-510k.jpg K870075 - CENTRAL VENOUS CATHETER K870075 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1987. https://www.510kdatabase.net/k871250/ 1987-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k871250-intra-articulated-arthro-power-system-fda-510k.jpg K871250 - INTRA-ARTICULATED ARTHRO POWER SYSTEM K871250 is a FDA 510(k) cleared pathology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Apr 1987. https://www.510kdatabase.net/k871414/ 1987-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k871414-emds-tibc-pretreatment-set-item-no-fda-510k.jpg K871414 - EMDS TIBC PRETREATMENT SET ITEM NO. 67612/93 K871414 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Apr 1987. https://www.510kdatabase.net/k863317/ 1987-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k863317-enzygnost-anti-vzv-igg-test-fda-510k.jpg K863317 - ENZYGNOST ANTI-VZV IGG TEST K863317 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Apr 1987. https://www.510kdatabase.net/k870544/ 1987-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k870544-biomek-1000-automated-laboratory-work-fda-510k.jpg K870544 - BIOMEK 1000 AUTOMATED LABORATORY WORK STATION K870544 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Apr 1987. https://www.510kdatabase.net/k871319/ 1987-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k871319-titan-gel-multi-slot-lipo-17-system-fda-510k.jpg K871319 - TITAN GEL MULTI-SLOT LIPO-17 SYSTEM K871319 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Apr 1987. https://www.510kdatabase.net/k871330/ 1987-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k871330-emds-gentamicin-calibrator-item-no-fda-510k.jpg K871330 - EMDS GENTAMICIN CALIBRATOR ITEM NO. 67628/95 K871330 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Apr 1987. https://www.510kdatabase.net/k871352/ 1987-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k871352-pentavalent-antiserum-to-human-fda-510k.jpg K871352 - PENTAVALENT ANTISERUM TO HUMAN IMMUNOGLOBULINS K871352 is a FDA 510(k) cleared immunology medical device. Manufacturer: Helena Laboratories. Cleared Apr 1987. https://www.510kdatabase.net/k865029/ 1987-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k865029-continu-flo-solution-admin-set-win-fda-510k.jpg K865029 - CONTINU-FLO SOLUTION ADMIN. SET W/IN-LINE FILTER K865029 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Apr 1987. https://www.510kdatabase.net/k870680/ 1987-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k870680-optical-consoletm-and-optical-cathetertm-fda-510k.jpg K870680 - OPTICAL CONSOLE(TM) AND OPTICAL CATHETER(TM) K870680 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medline Industries, Inc.. Cleared Apr 1987. https://www.510kdatabase.net/k870260/ 1987-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k870260-hickman-titanium-subcutaneous-port-fda-510k.jpg K870260 - HICKMAN TITANIUM SUBCUTANEOUS PORT K870260 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 1987. https://www.510kdatabase.net/k870752/ 1987-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k870752-seralyzer-ldhtotal-bilirubintriglyceride-fda-510k.jpg K870752 - SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS K870752 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Apr 1987. https://www.510kdatabase.net/k871306/ 1987-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k871306-emit-carbamazepine-assay-fda-510k.jpg K871306 - EMIT CARBAMAZEPINE ASSAY K871306 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Apr 1987. https://www.510kdatabase.net/k871324/ 1987-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k871324-du-pont-stericell-cell-culture-system-fda-510k.jpg K871324 - DU PONT STERICELL CELL CULTURE SYSTEM K871324 is a FDA 510(k) cleared pathology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Apr 1987. https://www.510kdatabase.net/k871357/ 1987-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k871357-mcbride-agar-modified-fda-510k.jpg K871357 - MCBRIDE AGAR, MODIFIED K871357 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1987. https://www.510kdatabase.net/k870552/ 1987-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k870552-affinity-digoxin-immunit-fda-510k.jpg K870552 - AFFINITY DIGOXIN IMMUNIT K870552 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1987. https://www.510kdatabase.net/k870986/ 1987-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k870986-liquid-stat-iron-reagent-kit-tibc-fda-510k.jpg K870986 - LIQUID-STAT IRON REAGENT KIT & TIBC REAGENT KIT K870986 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Apr 1987. https://www.510kdatabase.net/k871269/ 1987-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k871269-ra-system-analyte-serum-amylase-30c-fda-510k.jpg K871269 - RA SYSTEM, ANALYTE SERUM AMYLASE (30C AND 37C) K871269 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Apr 1987. https://www.510kdatabase.net/k870948/ 1987-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k870948-model-435-03-side-hook-implantable-fda-510k.jpg K870948 - MODEL 435-03 SIDE HOOK IMPLANTABLE PACING LEAD K870948 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Apr 1987. https://www.510kdatabase.net/k871049/ 1987-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k871049-capd-y-admin-set-used-winpersol-biocap-fda-510k.jpg K871049 - CAPD Y-ADMIN. SET USED W/INPERSOL BIOCAP ADMIN. K871049 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1987. https://www.510kdatabase.net/k871050/ 1987-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k871050-capd-admin-set-used-winpersol-capd-fda-510k.jpg K871050 - CAPD ADMIN. SET USED W/INPERSOL CAPD BIOCAP Y-ADM. K871050 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1987. https://www.510kdatabase.net/k864504/ 1987-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k864504-q5000-stress-test-monitor-fda-510k.jpg K864504 - Q5000 STRESS TEST MONITOR K864504 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Apr 1987. https://www.510kdatabase.net/k870675/ 1987-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k870675-additional-134cm-french-catheter-fda-510k.jpg K870675 - ADDITIONAL 13.4CM. FRENCH CATHETER INSERTION TRAY K870675 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Apr 1987. https://www.510kdatabase.net/k871286/ 1987-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k871286-gram-iodine-fda-510k.jpg K871286 - GRAM IODINE K871286 is a FDA 510(k) cleared pathology medical device. Manufacturer: Remel Co.. Cleared Apr 1987. https://www.510kdatabase.net/k863481/ 1987-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k863481-modification-of-accu-chek-ii-fda-510k.jpg K863481 - MODIFICATION OF ACCU-CHEK II K863481 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Apr 1987. https://www.510kdatabase.net/k864720/ 1987-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k864720-light-cured-periodontal-dressing-fda-510k.jpg K864720 - LIGHT-CURED PERIODONTAL DRESSING K864720 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Apr 1987. https://www.510kdatabase.net/k870169/ 1987-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k870169-capillary-flow-dialyzers-fda-510k.jpg K870169 - CAPILLARY FLOW DIALYZERS K870169 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Apr 1987. https://www.510kdatabase.net/k871118/ 1987-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k871118-modified-townley-unicondylar-knee-fda-510k.jpg K871118 - MODIFIED TOWNLEY UNICONDYLAR KNEE K871118 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Apr 1987. https://www.510kdatabase.net/k870262/ 1987-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k870262-fenlin-ii-shoulder-prosthesis-fda-510k.jpg K870262 - FENLIN II SHOULDER PROSTHESIS K870262 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Apr 1987. https://www.510kdatabase.net/k870388/ 1987-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k870388-hoffmann-leg-lengthening-plate-system-fda-510k.jpg K870388 - HOFFMANN LEG LENGTHENING PLATE SYSTEM K870388 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Apr 1987. https://www.510kdatabase.net/k871088/ 1987-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k871088-anaerobic-lkv-blood-agar-fda-510k.jpg K871088 - ANAEROBIC LKV BLOOD AGAR K871088 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Apr 1987. https://www.510kdatabase.net/k871089/ 1987-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k871089-anaerobic-blood-agar-cdc-formulation-fda-510k.jpg K871089 - ANAEROBIC BLOOD AGAR (CDC FORMULATION) K871089 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Apr 1987. https://www.510kdatabase.net/k871090/ 1987-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k871090-anaerobic-pea-blood-agar-fda-510k.jpg K871090 - ANAEROBIC PEA BLOOD AGAR K871090 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Apr 1987. https://www.510kdatabase.net/k871091/ 1987-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k871091-bacteroides-bile-esculin-agar-fda-510k.jpg K871091 - BACTEROIDES BILE ESCULIN AGAR K871091 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Apr 1987. https://www.510kdatabase.net/k871092/ 1987-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k871092-horse-blood-agar-enriched-fda-510k.jpg K871092 - HORSE BLOOD AGAR, ENRICHED K871092 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Apr 1987. https://www.510kdatabase.net/k871093/ 1987-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k871093-chocolate-agar-wbacitracin-haem-isol-fda-510k.jpg K871093 - CHOCOLATE AGAR W/BACITRACIN (HAEM. ISOL. AGAR) K871093 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Apr 1987. https://www.510kdatabase.net/k871094/ 1987-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k871094-brilliant-green-agar-fda-510k.jpg K871094 - BRILLIANT GREEN AGAR K871094 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Apr 1987. https://www.510kdatabase.net/k871095/ 1987-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k871095-cled-agar-fda-510k.jpg K871095 - CLED AGAR K871095 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Apr 1987. https://www.510kdatabase.net/k871096/ 1987-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k871096-cystine-tryptic-agar-wo-carbohydrates-fda-510k.jpg K871096 - CYSTINE TRYPTIC AGAR W/O CARBOHYDRATES K871096 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Apr 1987. https://www.510kdatabase.net/k871097/ 1987-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k871097-chocolate-mueller-hinton-agar-fda-510k.jpg K871097 - CHOCOLATE MUELLER HINTON AGAR K871097 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Apr 1987. https://www.510kdatabase.net/k871098/ 1987-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k871098-tryptic-soy-agar-fda-510k.jpg K871098 - TRYPTIC SOY AGAR K871098 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Apr 1987. https://www.510kdatabase.net/k871117/ 1987-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k871117-tb-quick-staintm-kit-fda-510k.jpg K871117 - TB QUICK STAIN(TM) KIT K871117 is a FDA 510(k) cleared pathology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1987. https://www.510kdatabase.net/k871191/ 1987-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k871191-dmff-12-hybri-maxtm-wl-glutamine-fda-510k.jpg K871191 - (DMF/F-12) HYBRI-MAX(TM) W/L-GLUTAMINE K871191 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Apr 1987. https://www.510kdatabase.net/k870244/ 1987-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k870244-iq-tsh-immunoassay-fda-510k.jpg K870244 - IQ TSH IMMUNOASSAY K870244 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1987. https://www.510kdatabase.net/k870672/ 1987-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k870672-aca-human-chorionic-gonadotropin-hcg-fda-510k.jpg K870672 - ACA HUMAN CHORIONIC GONADOTROPIN (HCG) METHOD K870672 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Apr 1987. https://www.510kdatabase.net/k870785/ 1987-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k870785-soft-tissue-biopsy-needle-fda-510k.jpg K870785 - SOFT TISSUE BIOPSY NEEDLE K870785 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1987. https://www.510kdatabase.net/k870915/ 1987-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k870915-simpulse-arthroscopy-irrigation-system-fda-510k.jpg K870915 - SIMPULSE ARTHROSCOPY IRRIGATION SYSTEM K870915 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 1987. https://www.510kdatabase.net/k870951/ 1987-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k870951-digoxin-fpia-reagent-set-fda-510k.jpg K870951 - DIGOXIN FPIA REAGENT SET K870951 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Apr 1987. https://www.510kdatabase.net/k870787/ 1987-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k870787-abbott-spectrum-ammonia-reagent-fda-510k.jpg K870787 - ABBOTT SPECTRUM AMMONIA REAGENT K870787 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1987. https://www.510kdatabase.net/k870952/ 1987-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k870952-theophylline-fpia-reagent-set-fda-510k.jpg K870952 - THEOPHYLLINE FPIA REAGENT SET K870952 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Mar 1987. https://www.510kdatabase.net/k870953/ 1987-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k870953-phenytoin-fpia-reagent-set-fda-510k.jpg K870953 - PHENYTOIN FPIA REAGENT SET K870953 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Mar 1987. https://www.510kdatabase.net/k870478/ 1987-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k870478-dulbeccos-mod-eagle-med-nut-mix-f-12-fda-510k.jpg K870478 - DULBECCO'S MOD. EAGLE MED. NUT. MIX. F-12 #D2906 K870478 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Mar 1987. https://www.510kdatabase.net/k870479/ 1987-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k870479-dme-hybri-max-wl-glutamine-product-no-fda-510k.jpg K870479 - (DME) HYBRI-MAX W/L-GLUTAMINE PRODUCT NO. D6780 K870479 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Mar 1987. https://www.510kdatabase.net/k870480/ 1987-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k870480-nctc-135-medium-hybri-max-wl-glutamine-fda-510k.jpg K870480 - NCTC 135 MEDIUM HYBRI-MAX W/L-GLUTAMINE #N5138 K870480 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Mar 1987. https://www.510kdatabase.net/k870481/ 1987-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k870481-s-mem-auto-mod-product-no-m7272-fda-510k.jpg K870481 - (S-MEM) AUTO-MOD PRODUCT NO. M7272 K870481 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Mar 1987. https://www.510kdatabase.net/k870482/ 1987-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k870482-d-pbs-modified-hybri-max-product-no-fda-510k.jpg K870482 - (D-PBS) MODIFIED HYBRI-MAX PRODUCT NO. D7030 K870482 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Mar 1987. https://www.510kdatabase.net/k870483/ 1987-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k870483-williams-medium-e-wl-glutamine-w4125-fda-510k.jpg K870483 - WILLIAMS' MEDIUM E W/L-GLUTAMINE #W4125 K870483 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Mar 1987. https://www.510kdatabase.net/k870484/ 1987-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k870484-hanks-balanced-salts-hbss-no-h1387-fda-510k.jpg K870484 - HANKS' BALANCED SALTS (HBSS) NO. H1387 K870484 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Mar 1987. https://www.510kdatabase.net/k870485/ 1987-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k870485-lactalbumin-hydrolysate-elah-no-l3762-fda-510k.jpg K870485 - LACTALBUMIN HYDROLYSATE (ELAH) NO. L3762 K870485 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Mar 1987. https://www.510kdatabase.net/k870486/ 1987-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k870486-earles-balanced-salts-ebss-hybri-max-fda-510k.jpg K870486 - EARLE'S BALANCED SALTS (EBSS) HYBRI-MAX #E9509 K870486 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Mar 1987. https://www.510kdatabase.net/k870487/ 1987-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k870487-h-y-medium-dmenctc109-71-mix-hybri-max-fda-510k.jpg K870487 - H-Y MEDIUM (DME:NCTC109, 7:1 MIX.) HYBRI-MAX H9014 K870487 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Mar 1987. https://www.510kdatabase.net/k870488/ 1987-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k870488-rpmi-1640-medium-defi-modification-no-fda-510k.jpg K870488 - RPMI 1640 MEDIUM DEFI. MODIFICATION NO. R7130 K870488 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Mar 1987. https://www.510kdatabase.net/k870489/ 1987-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k870489-rpmi-1640-medium-wl-glutamine-no-r8755-fda-510k.jpg K870489 - RPMI 1640 MEDIUM W/L-GLUTAMINE NO. R8755 K870489 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Mar 1987. https://www.510kdatabase.net/k870490/ 1987-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k870490-dme-w1000-mg-glucosel-no-d4655-fda-510k.jpg K870490 - (DME) W/1000 MG GLUCOSE/L NO. D4655 K870490 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Mar 1987. https://www.510kdatabase.net/k870491/ 1987-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k870491-krebs-ringer-bicarbonate-buffer-fda-510k.jpg K870491 - KREBS-RINGER BICARBONATE BUFFER PRODUCT NO. K4002 K870491 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Mar 1987. https://www.510kdatabase.net/k870492/ 1987-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k870492-dulbeccos-modified-eagle-medium-base-fda-510k.jpg K870492 - DULBECCO'S MODIFIED EAGLE MEDIUM BASE NO. D5030 K870492 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Mar 1987. https://www.510kdatabase.net/k870493/ 1987-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k870493-nutrient-mixture-f-12-ham-hepes-fda-510k.jpg K870493 - NUTRIENT MIXTURE F-12 (HAM) (HEPES BUFFERED) N4388 K870493 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Mar 1987. https://www.510kdatabase.net/k870494/ 1987-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k870494-rpmi-1640-hybri-max-product-no-r8005-fda-510k.jpg K870494 - RPMI-1640 HYBRI-MAX PRODUCT NO. R8005 K870494 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Mar 1987. https://www.510kdatabase.net/k870495/ 1987-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k870495-dme-auto-mod-modified-for-autoclaving-fda-510k.jpg K870495 - (DME) AUTO-MOD MODIFIED FOR AUTOCLAVING #D5280 K870495 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Mar 1987. https://www.510kdatabase.net/k870496/ 1987-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k870496-dulbecco-modi-eagle-meddme-hybri-max-tm-fda-510k.jpg K870496 - DULBECCO MODI EAGLE MED((DME) HYBRI-MAX (TM) K870496 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Mar 1987. https://www.510kdatabase.net/k870497/ 1987-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k870497-bgjb-medfitton-jackson-modwl-glutwo-fda-510k.jpg K870497 - BGJB MED(FITTON JACKSON MOD)W/L-GLUT/W/O SOD BICAR K870497 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Mar 1987. https://www.510kdatabase.net/k870498/ 1987-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k870498-iscove-mod-dulbecco-med-hybri-max-fda-510k.jpg K870498 - ISCOVE MOD DULBECCO MED HYBRI-MAX, PRODUCT# I2510 K870498 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Mar 1987. https://www.510kdatabase.net/k870499/ 1987-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k870499-mccoy-5a-med-mod-suuspension-culture-fda-510k.jpg K870499 - MCCOY 5A MED (MOD) SUUSPENSION CULTURE, M6523 K870499 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Mar 1987. https://www.510kdatabase.net/k870529/ 1987-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k870529-f-12-medium-coons-modification-product-fda-510k.jpg K870529 - F-12 MEDIUM, COON'S MODIFICATION PRODUCT NO. F6636 K870529 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Mar 1987. https://www.510kdatabase.net/k870530/ 1987-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k870530-medium-199-with-earles-salts-product-fda-510k.jpg K870530 - MEDIUM 199 WITH EARLE'S SALTS PRODUCT NO. M2520 K870530 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Mar 1987. https://www.510kdatabase.net/k870985/ 1987-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k870985-3m-instant-fit-custom-earmold-fda-510k.jpg K870985 - 3M INSTANT FIT CUSTOM EARMOLD K870985 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: 3M Company. Cleared Mar 1987. https://www.510kdatabase.net/k864151/ 1987-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k864151-280sl-imaging-system-tranvaginal-probes-fda-510k.jpg K864151 - 280SL IMAGING SYSTEM TRANVAGINAL PROBES K864151 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Mar 1987. https://www.510kdatabase.net/k862632/ 1987-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k862632-insallbursteintm-ii-tibial-wedges-fda-510k.jpg K862632 - INSALL/BURSTEIN(TM)* II TIBIAL WEDGES K862632 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Mar 1987. https://www.510kdatabase.net/k870664/ 1987-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k870664-guide-wire-fda-510k.jpg K870664 - GUIDE WIRE K870664 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Mar 1987. https://www.510kdatabase.net/k870930/ 1987-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k870930-tina-quantr-a-c3-fda-510k.jpg K870930 - TINA-QUANT(R) (A) C3 K870930 is a FDA 510(k) cleared immunology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Mar 1987. https://www.510kdatabase.net/k870931/ 1987-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k870931-tina-quantr-a-c4-fda-510k.jpg K870931 - TINA-QUANT(R) (A) C4 K870931 is a FDA 510(k) cleared immunology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Mar 1987. https://www.510kdatabase.net/k870994/ 1987-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k870994-abuscreen-radioimmunoassay-for-fda-510k.jpg K870994 - ABUSCREEN RADIOIMMUNOASSAY FOR BENZODIAZEPINES K870994 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Mar 1987. https://www.510kdatabase.net/k863708/ 1987-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k863708-75-mhz-sector-probe-model-gm-0317ss12-fda-510k.jpg K863708 - 7.5 MHZ SECTOR PROBE MODEL #GM-0317SS12 K863708 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 1987. https://www.510kdatabase.net/k870825/ 1987-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k870825-new-model-styles-for-aortic-arch-cannula-fda-510k.jpg K870825 - NEW MODEL STYLES FOR AORTIC ARCH CANNULA K870825 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Mar 1987. https://www.510kdatabase.net/k870826/ 1987-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k870826-additional-letter-designation-for-fda-510k.jpg K870826 - ADDITIONAL LETTER DESIGNATION FOR AORTIC ARCH CAN. K870826 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Mar 1987. https://www.510kdatabase.net/k870216/ 1987-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k870216-microstructured-spherical-acetabular-fda-510k.jpg K870216 - MICROSTRUCTURED SPHERICAL ACETABULAR COMPONENTS K870216 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Mar 1987. https://www.510kdatabase.net/k870445/ 1987-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k870445-threaded-acetabular-component-fda-510k.jpg K870445 - THREADED ACETABULAR COMPONENT K870445 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Mar 1987. https://www.510kdatabase.net/k870823/ 1987-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k870823-emit-nortriptyline-assay-fda-510k.jpg K870823 - EMIT NORTRIPTYLINE ASSAY K870823 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Mar 1987. https://www.510kdatabase.net/k863913/ 1987-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k863913-the-dpc-coat-a-count-serum-morphine-fda-510k.jpg K863913 - THE DPC COAT-A-COUNT SERUM MORPHINE RIA KIT K863913 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Mar 1987. https://www.510kdatabase.net/k870158/ 1987-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k870158-stratus-free-thyroxine-ft4-fluor-fda-510k.jpg K870158 - STRATUS FREE THYROXINE (FT4) FLUOR. ENZYME IMMUNO. K870158 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Mar 1987. https://www.510kdatabase.net/k870673/ 1987-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k870673-aca-human-chorionic-gonadotropin-hcg-fda-510k.jpg K870673 - ACA HUMAN CHORIONIC GONADOTROPIN (HCG) CALIBRATOR K870673 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Mar 1987. https://www.510kdatabase.net/k870740/ 1987-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k870740-coat-a-count-cocaine-metabolite-tkcn1-fda-510k.jpg K870740 - COAT-A-COUNT COCAINE METABOLITE TKCN1 & TKCN5 K870740 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Mar 1987. https://www.510kdatabase.net/k870868/ 1987-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k870868-easy-test-uric-acid-uric-16606-fda-510k.jpg K870868 - EASY-TEST URIC ACID (URIC) #16606 K870868 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Mar 1987. https://www.510kdatabase.net/k870875/ 1987-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k870875-coat-a-count-pcp-kit-number-tkpc1-fda-510k.jpg K870875 - COAT-A-COUNT PCP KIT NUMBER TKPC1 K870875 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Mar 1987. https://www.510kdatabase.net/k870935/ 1987-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k870935-coat-a-count-methaqualone-tkmq1-fda-510k.jpg K870935 - COAT-A-COUNT METHAQUALONE TKMQ1 K870935 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Mar 1987. https://www.510kdatabase.net/k870936/ 1987-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k870936-coat-a-count-barbiturates-tkba1-and-fda-510k.jpg K870936 - COAT-A-COUNT BARBITURATES TKBA1 AND TKBA5 K870936 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Mar 1987. https://www.510kdatabase.net/k870937/ 1987-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k870937-coat-a-count-methadone-tkmd1-fda-510k.jpg K870937 - COAT-A-COUNT METHADONE TKMD1 K870937 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Mar 1987. https://www.510kdatabase.net/k870211/ 1987-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k870211-bondex-glass-ionomer-cement-fda-510k.jpg K870211 - BONDEX* GLASS IONOMER CEMENT K870211 is a FDA 510(k) cleared dental medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Mar 1987. https://www.510kdatabase.net/k870898/ 1987-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k870898-ultra-lux-light-source-fda-510k.jpg K870898 - ULTRA-LUX LIGHT SOURCE K870898 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medline Industries, Inc.. Cleared Mar 1987. https://www.510kdatabase.net/k864756/ 1987-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k864756-norfloxacin-10-mcg-sensi-disc-fda-510k.jpg K864756 - NORFLOXACIN 10 MCG SENSI DISC K864756 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1987. https://www.510kdatabase.net/k870940/ 1987-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k870940-solution-admini-sets-alter-drip-fda-510k.jpg K870940 - SOLUTION ADMINI. SETS- ALTER. DRIP CHAMBER/CONNEC. K870940 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Mar 1987. https://www.510kdatabase.net/k863843/ 1987-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k863843-cocaine-metabolite-rocher-eia-fda-510k.jpg K863843 - COCAINE METABOLITE ROCHE(R) EIA K863843 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Mar 1987. https://www.510kdatabase.net/k864131/ 1987-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k864131-visiontm-crp-fda-510k.jpg K864131 - VISION(TM) CRP K864131 is a FDA 510(k) cleared immunology medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1987. https://www.510kdatabase.net/k864168/ 1987-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k864168-morphine-roche-r-eia-test-fda-510k.jpg K864168 - MORPHINE ROCHE (R) EIA TEST K864168 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Mar 1987. https://www.510kdatabase.net/k864374/ 1987-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k864374-argyle-sentinel-seal-autotransfusion-fda-510k.jpg K864374 - ARGYLE SENTINEL SEAL AUTOTRANSFUSION SYSTEM K864374 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sherwood Medical Co.. Cleared Mar 1987. https://www.510kdatabase.net/k865104/ 1987-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k865104-iq-fti-immunoassay-fda-510k.jpg K865104 - IQ FTI IMMUNOASSAY K865104 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1987. https://www.510kdatabase.net/k870377/ 1987-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k870377-abuscreen-r-eia-cannabinoids-fda-510k.jpg K870377 - ABUSCREEN (R) EIA CANNABINOIDS K870377 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Mar 1987. https://www.510kdatabase.net/k870378/ 1987-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k870378-abuscreen-r-eia-barbiturate-fda-510k.jpg K870378 - ABUSCREEN (R) EIA BARBITURATE K870378 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Mar 1987. https://www.510kdatabase.net/k863245/ 1987-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k863245-syva-ets-system-fda-510k.jpg K863245 - SYVA ETS SYSTEM K863245 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Mar 1987. https://www.510kdatabase.net/k864751/ 1987-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k864751-tdxr-cannabinoids-fda-510k.jpg K864751 - TDXR CANNABINOIDS K864751 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1987. https://www.510kdatabase.net/k870106/ 1987-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k870106-coat-a-count-irma-hcg-kit-and-its-fda-510k.jpg K870106 - COAT-A-COUNT IRMA HCG KIT AND ITS COMPONENTS K870106 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Mar 1987. https://www.510kdatabase.net/k870795/ 1987-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k870795-emg-electrodes-and-extension-cords-fda-510k.jpg K870795 - EMG ELECTRODES AND EXTENSION CORDS K870795 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Mar 1987. https://www.510kdatabase.net/k864438/ 1987-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k864438-beckman-epsilontm-lipase-test-kit-fda-510k.jpg K864438 - BECKMAN EPSILON(TM) LIPASE TEST KIT K864438 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Mar 1987. https://www.510kdatabase.net/k864658/ 1987-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k864658-iq-free-t4-immunoassay-fda-510k.jpg K864658 - IQ FREE T4 IMMUNOASSAY K864658 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1987. https://www.510kdatabase.net/k864737/ 1987-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k864737-nibp-non-invas-blood-press-cart-model-fda-510k.jpg K864737 - NIBP NON-INVAS. BLOOD PRESS. CART. MODEL 88 35 340 K864737 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 1987. https://www.510kdatabase.net/k865081/ 1987-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k865081-affinitytm-htsh-immunittm-fda-510k.jpg K865081 - AFFINITY(TM) HTSH IMMUNIT(TM) K865081 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1987. https://www.510kdatabase.net/k865105/ 1987-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k865105-affinitytm-system-fda-510k.jpg K865105 - AFFINITY(TM) SYSTEM K865105 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1987. https://www.510kdatabase.net/k870151/ 1987-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k870151-totalige-theophylline-control-sera-fda-510k.jpg K870151 - TOTAL/IGE THEOPHYLLINE CONTROL SERA K870151 is a FDA 510(k) cleared immunology medical device. Manufacturer: 3M Company. Cleared Mar 1987. https://www.510kdatabase.net/k870570/ 1987-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k870570-ferritin-mab-solid-phase-component-fda-510k.jpg K870570 - FERRITIN MAB SOLID PHASE COMPONENT SYSTEM K870570 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1987. https://www.510kdatabase.net/k870380/ 1987-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k870380-model-78534c-monitorterminal-woptions-fda-510k.jpg K870380 - MODEL 78534C MONITOR/TERMINAL W/OPTIONS A03 K870380 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Mar 1987. https://www.510kdatabase.net/k864970/ 1987-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k864970-terumo-dental-needles-fda-510k.jpg K864970 - TERUMO DENTAL NEEDLES K864970 is a FDA 510(k) cleared dental medical device. Manufacturer: Terumo Medical Corp.. Cleared Mar 1987. https://www.510kdatabase.net/k865030/ 1987-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k865030-cardiofax-v-ecg-8240a-fda-510k.jpg K865030 - CARDIOFAX-V ECG-8240A K865030 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Mar 1987. https://www.510kdatabase.net/k865032/ 1987-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k865032-cardiofax-v-ecg-834oa-fda-510k.jpg K865032 - CARDIOFAX-V ECG-834OA K865032 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Mar 1987. https://www.510kdatabase.net/k870145/ 1987-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k870145-external-y-valve-5c4198-fda-510k.jpg K870145 - EXTERNAL Y VALVE 5C4198 K870145 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Mar 1987. https://www.510kdatabase.net/k870155/ 1987-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k870155-directigen-meningitis-combo-test-b-fda-510k.jpg K870155 - DIRECTIGEN MENINGITIS COMBO TEST & (B) STREP TEST K870155 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1987. https://www.510kdatabase.net/k870462/ 1987-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k870462-easy-test-creatine-kinase-mb-ck-mb-16615-fda-510k.jpg K870462 - EASY-TEST CREATINE KINASE-MB (CK-MB) #16615 K870462 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Mar 1987. https://www.510kdatabase.net/k863618/ 1987-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k863618-bone-mineral-densitometry-option-b7918aa-fda-510k.jpg K863618 - BONE MINERAL DENSITOMETRY OPTION B7918AA K863618 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Mar 1987. https://www.510kdatabase.net/k864632/ 1987-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k864632-pca-modular-knee-system-fda-510k.jpg K864632 - P.C.A. MODULAR KNEE SYSTEM K864632 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Mar 1987. https://www.510kdatabase.net/k870170/ 1987-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k870170-easy-test-calcium-ca-item-no-6752893-fda-510k.jpg K870170 - EASY-TEST CALCIUM (CA), ITEM NO. 67528/93 K870170 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Mar 1987. https://www.510kdatabase.net/k870399/ 1987-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k870399-selverstone-clamp-salibi-clamp-fda-510k.jpg K870399 - SELVERSTONE CLAMP SALIBI CLAMP K870399 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Mar 1987. https://www.510kdatabase.net/k870461/ 1987-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k870461-easy-test-creatine-kinase-ck-number-fda-510k.jpg K870461 - EASY-TEST CREATINE KINASE (CK) NUMBER: 16614 K870461 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Mar 1987. https://www.510kdatabase.net/k870553/ 1987-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k870553-easy-test-magnesium-mg-item-no-16xxx-fda-510k.jpg K870553 - EASY-TEST MAGNESIUM (MG) ITEM NO. 16XXX K870553 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Mar 1987. https://www.510kdatabase.net/k864222/ 1987-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k864222-series-620-rectal-probe-cover-fda-510k.jpg K864222 - SERIES 620 RECTAL PROBE COVER K864222 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Mar 1987. https://www.510kdatabase.net/k870407/ 1987-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k870407-easy-test-cholesterolchol-number-16607-fda-510k.jpg K870407 - EASY-TEST CHOLESTEROL(CHOL) NUMBER 16607 K870407 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Mar 1987. https://www.510kdatabase.net/k870408/ 1987-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k870408-easy-test-triglyceride-trig-number-16608-fda-510k.jpg K870408 - EASY-TEST TRIGLYCERIDE (TRIG) NUMBER 16608 K870408 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Mar 1987. https://www.510kdatabase.net/k870571/ 1987-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k870571-emds-urea-nitrogen-bun-testpacks-item-fda-510k.jpg K870571 - EMDS UREA NITROGEN (BUN) TESTPACKS ITEM #67654/95 K870571 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Mar 1987. https://www.510kdatabase.net/k864752/ 1987-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k864752-abbott-testpacktm-strep-a-positive-fda-510k.jpg K864752 - ABBOTT TESTPACK(TM) STREP A POSITIVE CONTROL K864752 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Feb 1987. https://www.510kdatabase.net/k865048/ 1987-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k865048-eclipse-model-number-7723-fda-510k.jpg K865048 - ECLIPSE+, MODEL NUMBER 7723 K865048 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Feb 1987. https://www.510kdatabase.net/k870379/ 1987-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k870379-ise-compensation-sera-fda-510k.jpg K870379 - ISE COMPENSATION SERA K870379 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Feb 1987. https://www.510kdatabase.net/k870565/ 1987-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k870565-kodak-x-omatic-ident-camera-models-2-fda-510k.jpg K870565 - KODAK X-OMATIC IDENT. CAMERA, MODELS 2 AND 2L K870565 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Feb 1987. https://www.510kdatabase.net/k870701/ 1987-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k870701-kodak-x-omatic-identification-camera-fda-510k.jpg K870701 - KODAK X-OMATIC IDENTIFICATION CAMERA DIGITAL K870701 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Feb 1987. https://www.510kdatabase.net/k864888/ 1987-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k864888-microtrak-chlamydia-trachomatis-direct-fda-510k.jpg K864888 - MICROTRAK CHLAMYDIA TRACHOMATIS DIRECT SPECI. TEST K864888 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Syva Co.. Cleared Feb 1987. https://www.510kdatabase.net/k864949/ 1987-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k864949-instruction-change-for-right-fda-510k.jpg K864949 - INSTRUCTION CHANGE FOR RIGHT ATRIAL/RAAF CATHETER K864949 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Quinton, Inc.. Cleared Feb 1987. https://www.510kdatabase.net/k870406/ 1987-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k870406-smi-digitron-fda-510k.jpg K870406 - SMI DIGITRON K870406 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Feb 1987. https://www.510kdatabase.net/k870472/ 1987-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k870472-acute-peritoneal-dialysis-kit-fda-510k.jpg K870472 - ACUTE PERITONEAL DIALYSIS KIT K870472 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quinton, Inc.. Cleared Feb 1987. https://www.510kdatabase.net/k870543/ 1987-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k870543-steri-tractor-wound-retractor-fda-510k.jpg K870543 - STERI-TRACTOR WOUND RETRACTOR K870543 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3M Company. Cleared Feb 1987. https://www.510kdatabase.net/k863469/ 1987-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k863469-codetron-transcutaneous-electrical-fda-510k.jpg K863469 - CODETRON TRANSCUTANEOUS ELECTRICAL NERVE STIMULA. K863469 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cordis Corp.. Cleared Feb 1987. https://www.510kdatabase.net/k864320/ 1987-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k864320-sentron-pressure-measuring-fda-510k.jpg K864320 - SENTRON PRESSURE MEASURING CATH/PRESSURE INTERFACE K864320 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Feb 1987. https://www.510kdatabase.net/k864834/ 1987-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k864834-olympus-pk300-fda-510k.jpg K864834 - OLYMPUS PK300 K864834 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Feb 1987. https://www.510kdatabase.net/k865068/ 1987-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k865068-accupoint-toxo-fda-510k.jpg K865068 - ACCUPOINT TOXO K865068 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Syva Co.. Cleared Feb 1987. https://www.510kdatabase.net/k870012/ 1987-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k870012-triglyceride-gpo-trinder-reagent-fda-510k.jpg K870012 - TRIGLYCERIDE (GPO-TRINDER) REAGENT K870012 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Feb 1987. https://www.510kdatabase.net/k870120/ 1987-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k870120-digilab-model-1500-perimeter-fda-510k.jpg K870120 - DIGILAB MODEL 1500 PERIMETER K870120 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Bio-Rad. Cleared Feb 1987. https://www.510kdatabase.net/k870121/ 1987-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k870121-digilab-micro-one-applanation-tonometer-fda-510k.jpg K870121 - DIGILAB MICRO ONE APPLANATION TONOMETER K870121 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Bio-Rad. Cleared Feb 1987. https://www.510kdatabase.net/k870144/ 1987-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k870144-ironirn-testpack-item-no-6765995-fda-510k.jpg K870144 - IRON(IRN) TESTPACK, ITEM NO. 67659/95 K870144 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Feb 1987. https://www.510kdatabase.net/k854371/ 1987-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k854371-mtc-6210a-cardiac-output-computer-fda-510k.jpg K854371 - MTC 6210A CARDIAC OUTPUT COMPUTER K854371 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Feb 1987. https://www.510kdatabase.net/k855247/ 1987-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k855247-interoperative-linearsector-ultrasound-fda-510k.jpg K855247 - INTEROPERATIVE LINEAR/SECTOR ULTRASOUND SCANNER K855247 is a FDA 510(k) cleared radiology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Feb 1987. https://www.510kdatabase.net/k863891/ 1987-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k863891-modified-stbp-680-fda-510k.jpg K863891 - MODIFIED STBP-680 K863891 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Feb 1987. https://www.510kdatabase.net/k864700/ 1987-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k864700-q700-electrocardiograph-fda-510k.jpg K864700 - Q700 ELECTROCARDIOGRAPH K864700 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Feb 1987. https://www.510kdatabase.net/k864787/ 1987-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k864787-schneider-shiley-guide-wire-fda-510k.jpg K864787 - SCHNEIDER-SHILEY GUIDE WIRE K864787 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Feb 1987. https://www.510kdatabase.net/k864890/ 1987-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k864890-stockert-shiley-caps-venous-occlusion-fda-510k.jpg K864890 - STOCKERT-SHILEY CAPS VENOUS OCCLUSION CLAMP K864890 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Feb 1987. https://www.510kdatabase.net/k864895/ 1987-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k864895-intersept-cardiotomy-reservoir-with-fda-510k.jpg K864895 - INTERSEPT* CARDIOTOMY RESERVOIR WITH FILTER K864895 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Feb 1987. https://www.510kdatabase.net/k864996/ 1987-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k864996-ultrasonic-scaler-3000-prophy-jet-30-fda-510k.jpg K864996 - ULTRASONIC SCALER 3000/ PROPHY-JET 30/ CAVI-JET 30 K864996 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Feb 1987. https://www.510kdatabase.net/k865031/ 1987-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k865031-electrocardiograph-fda-510k.jpg K865031 - ELECTROCARDIOGRAPH K865031 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Feb 1987. https://www.510kdatabase.net/k864530/ 1987-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k864530-seralyzer-glucose-hk-reagent-fda-510k.jpg K864530 - SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI. K864530 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Feb 1987. https://www.510kdatabase.net/k864838/ 1987-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k864838-simultrac-free-t457cotsh-mab125i-fda-510k.jpg K864838 - SIMULTRAC FREE T4[57CO]/TSH MAB[125I] K864838 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Feb 1987. https://www.510kdatabase.net/k865053/ 1987-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k865053-sera-tek-microsomal-antibody-test-fda-510k.jpg K865053 - SERA-TEK MICROSOMAL ANTIBODY TEST K865053 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Feb 1987. https://www.510kdatabase.net/k865096/ 1987-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k865096-new-second-french-size-mahurkar-catheter-fda-510k.jpg K865096 - NEW SECOND FRENCH SIZE MAHURKAR CATHETER K865096 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quinton, Inc.. Cleared Feb 1987. https://www.510kdatabase.net/k870246/ 1987-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k870246-reflotronr-ast-got-fda-510k.jpg K870246 - REFLOTRON(R) AST (GOT) K870246 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Feb 1987. https://www.510kdatabase.net/k864724/ 1987-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k864724-modi-of-dental-ceramic-for-fabrication-fda-510k.jpg K864724 - MODI. OF DENTAL CERAMIC FOR FABRICATION OF CROWN K864724 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Feb 1987. https://www.510kdatabase.net/k864705/ 1987-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k864705-modification-material-change-of-peel-fda-510k.jpg K864705 - MODIFICATION (MATERIAL CHANGE) OF PEEL-AWAY SHEATH K864705 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Feb 1987. https://www.510kdatabase.net/k864909/ 1987-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k864909-du-pont-liquid-multi-analyte-calibrator-fda-510k.jpg K864909 - DU PONT LIQUID MULTI-ANALYTE CALIBRATOR K864909 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Feb 1987. https://www.510kdatabase.net/k865034/ 1987-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k865034-aztreonam-30-mcg-sensi-disc-fda-510k.jpg K865034 - AZTREONAM 30 MCG. SENSI-DISC K865034 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Feb 1987. https://www.510kdatabase.net/k864104/ 1987-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k864104-additonal-allergens-for-ige-fast-tm-test-fda-510k.jpg K864104 - ADDITONAL ALLERGENS FOR IGE FAST (TM) TEST K864104 is a FDA 510(k) cleared immunology medical device. Manufacturer: 3M Company. Cleared Feb 1987. https://www.510kdatabase.net/k870153/ 1987-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k870153-allergen-specific-igg4-control-sera-fda-510k.jpg K870153 - ALLERGEN SPECIFIC IGG4 CONTROL SERA K870153 is a FDA 510(k) cleared immunology medical device. Manufacturer: 3M Company. Cleared Feb 1987. https://www.510kdatabase.net/k864739/ 1987-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k864739-kodak-ektascan-image-transmission-fda-510k.jpg K864739 - KODAK EKTASCAN IMAGE TRANSMISSION SYSTEM P1 K864739 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Feb 1987. https://www.510kdatabase.net/k864927/ 1987-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k864927-kodak-ektascan-image-trans-sys-t1r1-fda-510k.jpg K864927 - KODAK EKTASCAN IMAGE TRANS SYS T1/R1 SOFTWARE,1.10 K864927 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Feb 1987. https://www.510kdatabase.net/k870143/ 1987-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k870143-ammonia-amon-testpack-item-no-6768995-fda-510k.jpg K870143 - AMMONIA (AMON) TESTPACK, ITEM NO. 67689/95 K870143 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Feb 1987. https://www.510kdatabase.net/k870247/ 1987-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k870247-emit-quinidine-calibrator-item-no-fda-510k.jpg K870247 - EMIT QUINIDINE CALIBRATOR ITEM NO. 67631/93 K870247 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Feb 1987. https://www.510kdatabase.net/k863608/ 1987-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k863608-datascope-balloon-dilatation-catheter-fda-510k.jpg K863608 - DATASCOPE BALLOON DILATATION CATHETER K863608 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Feb 1987. https://www.510kdatabase.net/k863700/ 1987-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k863700-rt2800115vh4008c-and-rt2800220240vh4008c-fda-510k.jpg K863700 - RT2800(115V)/H4008C AND RT2800(220/240V)/H4008CE K863700 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Feb 1987. https://www.510kdatabase.net/k864349/ 1987-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k864349-mediport-ii-single-lumport-implant-fda-510k.jpg K864349 - MEDIPORT II SINGLE LUM/PORT IMPLANT VASC ACS PORT K864349 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Feb 1987. https://www.510kdatabase.net/k865019/ 1987-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k865019-aftr-hep-performance-evaluation-program-fda-510k.jpg K865019 - AFT(R) HEP PERFORMANCE EVALUATION PROGRAM K865019 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Feb 1987. https://www.510kdatabase.net/k870107/ 1987-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k870107-coat-a-count-irma-ferritin-kit-and-its-fda-510k.jpg K870107 - COAT-A-COUNT IRMA FERRITIN KIT AND ITS COMPONENTS K870107 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Feb 1987. https://www.510kdatabase.net/k870353/ 1987-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k870353-immunoadsorbed-factor-x-deficient-fda-510k.jpg K870353 - IMMUNOADSORBED FACTOR X DEFICIENT PLASMA (HUMAN) K870353 is a FDA 510(k) cleared hematology medical device. Manufacturer: American Dade. Cleared Feb 1987. https://www.510kdatabase.net/k870354/ 1987-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k870354-immunoadsorbed-factor-v-deficient-fda-510k.jpg K870354 - IMMUNOADSORBED FACTOR V DEFICIENT PLASMA (HUMAN) K870354 is a FDA 510(k) cleared hematology medical device. Manufacturer: American Dade. Cleared Feb 1987. https://www.510kdatabase.net/k863934/ 1987-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k863934-dpc-coat-a-count-irma-lh-kit-fda-510k.jpg K863934 - DPC COAT-A-COUNT IRMA LH KIT K863934 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Feb 1987. https://www.510kdatabase.net/k864664/ 1987-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k864664-h-1-setpoint-platelet-and-rbcwbc-fda-510k.jpg K864664 - H-1 SETPOINT PLATELET AND RBC/WBC CALIBRATORS K864664 is a FDA 510(k) cleared hematology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Feb 1987. https://www.510kdatabase.net/k864671/ 1987-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k864671-anatomic-modular-knee-amk-system-fda-510k.jpg K864671 - ANATOMIC MODULAR KNEE (AMK) SYSTEM K864671 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Feb 1987. https://www.510kdatabase.net/k865021/ 1987-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k865021-bactecr-nr-660-high-performance-system-fda-510k.jpg K865021 - BACTEC(R) NR-660 HIGH PERFORMANCE SYSTEM K865021 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Feb 1987. https://www.510kdatabase.net/k865058/ 1987-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k865058-abbott-lifecare-r-5000-pump-system-fda-510k.jpg K865058 - ABBOTT LIFECARE (R) 5000, PUMP SYSTEM K865058 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Feb 1987. https://www.510kdatabase.net/k865059/ 1987-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k865059-iv-set-wsingle-channel-cassette-fda-510k.jpg K865059 - I.V. SET W/SINGLE-CHANNEL CASSETTE K865059 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Feb 1987. https://www.510kdatabase.net/k865060/ 1987-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k865060-iv-set-with-dual-channel-cassette-fda-510k.jpg K865060 - I.V. SET WITH DUAL-CHANNEL CASSETTE K865060 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Feb 1987. https://www.510kdatabase.net/k870152/ 1987-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k870152-allergen-specific-controls-fda-510k.jpg K870152 - ALLERGEN SPECIFIC CONTROLS K870152 is a FDA 510(k) cleared immunology medical device. Manufacturer: 3M Company. Cleared Feb 1987. https://www.510kdatabase.net/k870213/ 1987-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k870213-modified-profile-femoral-hip-fda-510k.jpg K870213 - MODIFIED PROFILE FEMORAL HIP K870213 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Feb 1987. https://www.510kdatabase.net/k862610/ 1987-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k862610-ultra-vue-spinal-type-biopsy-needle-fda-510k.jpg K862610 - ULTRA-VUE SPINAL TYPE BIOPSY NEEDLE K862610 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Feb 1987. https://www.510kdatabase.net/k863864/ 1987-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k863864-ambulatory-infusion-pump-model-as30c-fda-510k.jpg K863864 - AMBULATORY INFUSION PUMP, MODEL AS30C K863864 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Feb 1987. https://www.510kdatabase.net/k864522/ 1987-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k864522-astra-systems-multiple-chemistry-module-fda-510k.jpg K864522 - ASTRA SYSTEMS MULTIPLE CHEMISTRY MODULE K864522 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Feb 1987. https://www.510kdatabase.net/k864566/ 1987-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k864566-adxtm-analyzer-fda-510k.jpg K864566 - ADX(TM) ANALYZER K864566 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Feb 1987. https://www.510kdatabase.net/k864591/ 1987-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k864591-hcg-solid-phase-component-system-fda-510k.jpg K864591 - HCG SOLID PHASE COMPONENT SYSTEM K864591 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Feb 1987. https://www.510kdatabase.net/k864839/ 1987-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k864839-tsh-mab-irma-fda-510k.jpg K864839 - TSH MAB IRMA K864839 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Feb 1987. https://www.510kdatabase.net/k862462/ 1987-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k862462-lifescope-6-oec-6120-portable-patient-fda-510k.jpg K862462 - LIFESCOPE 6, OEC-6120 PORTABLE PATIENT MONITOR REC K862462 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Feb 1987. https://www.510kdatabase.net/k864619/ 1987-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k864619-caps-low-level-detector-detectorbubble-fda-510k.jpg K864619 - CAPS LOW LEVEL DETECTOR & DETECTOR/BUBBLE MONITOR K864619 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Feb 1987. https://www.510kdatabase.net/k864803/ 1987-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k864803-gc-lecttm-fda-510k.jpg K864803 - GC-LECT(TM) K864803 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Feb 1987. https://www.510kdatabase.net/k865020/ 1987-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k865020-sera-tek-thyroglobulin-antibody-test-fda-510k.jpg K865020 - SERA-TEK THYROGLOBULIN ANTIBODY TEST K865020 is a FDA 510(k) cleared immunology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Feb 1987. https://www.510kdatabase.net/k864085/ 1987-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k864085-brooker-bio-groove-femoral-component-fda-510k.jpg K864085 - BROOKER BIO-GROOVE FEMORAL COMPONENT K864085 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jan 1987. https://www.510kdatabase.net/k864135/ 1987-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k864135-280sl-imaging-system-small-parts-probes-fda-510k.jpg K864135 - 280SL IMAGING SYSTEM SMALL PARTS PROBES K864135 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Jan 1987. https://www.510kdatabase.net/k864136/ 1987-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k864136-260sl-imaging-system-small-parts-probes-fda-510k.jpg K864136 - 260SL IMAGING SYSTEM SMALL PARTS PROBES K864136 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Jan 1987. https://www.510kdatabase.net/k864439/ 1987-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k864439-beckman-epsilontm-prolactin-test-kit-fda-510k.jpg K864439 - BECKMAN EPSILON(TM) PROLACTIN TEST KIT K864439 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jan 1987. https://www.510kdatabase.net/k864480/ 1987-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k864480-il-test-84668-15-factor-viii-control-fda-510k.jpg K864480 - IL TEST 84668-15, FACTOR VIII CONTROL PLASMA K864480 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jan 1987. https://www.510kdatabase.net/k864725/ 1987-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k864725-modi-dicor-castable-ceramicall-fda-510k.jpg K864725 - MODI. DICOR CASTABLE CERAMIC/ALL PORCELAIN BRIDGES K864725 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jan 1987. https://www.510kdatabase.net/k864973/ 1987-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k864973-tenzcaretm-snap-electrode-6867-fda-510k.jpg K864973 - TENZCARE(TM) SNAP ELECTRODE 6867 K864973 is a FDA 510(k) cleared neurology medical device. Manufacturer: 3M Company. Cleared Jan 1987. https://www.510kdatabase.net/k864326/ 1987-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k864326-model-366-13-adaptaid-step-down-adapter-fda-510k.jpg K864326 - MODEL 366-13 ADAPTAID STEP DOWN ADAPTER K864326 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Jan 1987. https://www.510kdatabase.net/k864437/ 1987-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k864437-beckman-epsilontm-ferritin-test-kit-fda-510k.jpg K864437 - BECKMAN EPSILON(TM) FERRITIN TEST KIT K864437 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jan 1987. https://www.510kdatabase.net/k861979/ 1987-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k861979-aml-ii-titanium-acetabulum-prosthesis-fda-510k.jpg K861979 - AML II TITANIUM ACETABULUM PROSTHESIS K861979 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jan 1987. https://www.510kdatabase.net/k863184/ 1987-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k863184-profile-hip-acetabulum-prosthesis-fda-510k.jpg K863184 - PROFILE HIP ACETABULUM PROSTHESIS K863184 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jan 1987. https://www.510kdatabase.net/k865061/ 1987-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k865061-shiley-dispos-cannula-fenes-lp-cuffed-fda-510k.jpg K865061 - SHILEY DISPOS CANNULA FENES LP CUFFED TRACHE TUBE K865061 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shiley, Inc.. Cleared Jan 1987. https://www.510kdatabase.net/k863042/ 1987-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k863042-sirecust-888888r-non-invasive-blood-fda-510k.jpg K863042 - SIRECUST 888/888R NON-INVASIVE BLOOD PRESS MONITOR K863042 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 1987. https://www.510kdatabase.net/k863132/ 1987-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k863132-digital-fluoricon-cardiacvascular-fda-510k.jpg K863132 - DIGITAL FLUORICON CARDIAC/VASCULAR QUANTITATIVE K863132 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jan 1987. https://www.510kdatabase.net/k863219/ 1987-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k863219-system-90-transport-fda-510k.jpg K863219 - SYSTEM 90 TRANSPORT K863219 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Jan 1987. https://www.510kdatabase.net/k863842/ 1987-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k863842-seralyzer-aris-carbamazepine-fda-510k.jpg K863842 - SERALYZER ARIS CARBAMAZEPINE STRIPS/MODU/CALI/CONT K863842 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Jan 1987. https://www.510kdatabase.net/k864868/ 1987-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k864868-microporous-monitoring-electrodes-fda-510k.jpg K864868 - MICROPOROUS MONITORING ELECTRODES & ADAPTER BLOCK K864868 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Jan 1987. https://www.510kdatabase.net/k864009/ 1987-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k864009-mingograf-410-fda-510k.jpg K864009 - MINGOGRAF 410 K864009 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 1987. https://www.510kdatabase.net/k864233/ 1987-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k864233-bard-harvard-mini-infuser-950-pump-fda-510k.jpg K864233 - BARD HARVARD MINI-INFUSER 950 PUMP K864233 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 1987. https://www.510kdatabase.net/k864285/ 1987-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k864285-terumo-ovation-spectrophotometer-fda-510k.jpg K864285 - TERUMO OVATION SPECTROPHOTOMETER K864285 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Terumo Medical Corp.. Cleared Jan 1987. https://www.510kdatabase.net/k864894/ 1987-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k864894-easy-test-alcohol-alc-item-no-6751593-fda-510k.jpg K864894 - EASY-TEST ALCOHOL (ALC), ITEM NO. 67515/93 K864894 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jan 1987. https://www.510kdatabase.net/k865014/ 1987-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k865014-liquichek-immunology-control-human-fda-510k.jpg K865014 - LIQUICHEK IMMUNOLOGY CONTROL (HUMAN) LEVELS I & II K865014 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Jan 1987. https://www.510kdatabase.net/k864553/ 1987-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k864553-easy-test-carbamazepine-item-no-67-95-fda-510k.jpg K864553 - EASY-TEST CARBAMAZEPINE ITEM NO. 67---/95 K864553 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jan 1987. https://www.510kdatabase.net/k864607/ 1987-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k864607-easy-test-quinidine-item-no-67-95-fda-510k.jpg K864607 - EASY-TEST QUINIDINE ITEM NO. 67---/95 K864607 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jan 1987. https://www.510kdatabase.net/k864554/ 1987-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k864554-easy-test-primidone-item-no-67-95-fda-510k.jpg K864554 - EASY-TEST PRIMIDONE ITEM NO. 67---/95 K864554 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jan 1987. https://www.510kdatabase.net/k864925/ 1987-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k864925-emds-tm-phenytoin-ptn-testpack-item-fda-510k.jpg K864925 - EMDS TM PHENYTOIN (PTN) TESTPACK, ITEM #67676/95 K864925 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jan 1987. https://www.510kdatabase.net/k864926/ 1987-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k864926-emds-tm-phenobarbitalphno-testpack-fda-510k.jpg K864926 - EMDS TM PHENOBARBITAL(PHNO) TESTPACK, #67677/95 K864926 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jan 1987. https://www.510kdatabase.net/k862051/ 1987-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k862051-model-436-01-biopore-implantable-fda-510k.jpg K862051 - MODEL 436-01 BIOPORE IMPLANTABLE PACING LEAD K862051 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Jan 1987. https://www.510kdatabase.net/k863536/ 1987-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k863536-medtronic-model-5013-fda-510k.jpg K863536 - MEDTRONIC MODEL 5013 K863536 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jan 1987. https://www.510kdatabase.net/k863855/ 1987-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k863855-accusat-fda-510k.jpg K863855 - ACCUSAT K863855 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Datascope Corp.. Cleared Jan 1987. https://www.510kdatabase.net/k864331/ 1987-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k864331-tri-lock-long-stem-modular-neck-fda-510k.jpg K864331 - TRI-LOCK LONG STEM MODULAR NECK K864331 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jan 1987. https://www.510kdatabase.net/k864352/ 1987-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k864352-modified-peel-away-introducer-set-line-fda-510k.jpg K864352 - MODIFIED PEEL-AWAY INTRODUCER SET LINE K864352 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Jan 1987. https://www.510kdatabase.net/k864640/ 1987-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k864640-ancor-pervenous-active-fixation-fda-510k.jpg K864640 - ANCOR PERVENOUS ACTIVE FIXATION UNIPOLAR LEAD K864640 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Jan 1987. https://www.510kdatabase.net/k864738/ 1987-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k864738-model-366-14-intermedics-lead-fda-510k.jpg K864738 - MODEL 366-14 INTERMEDICS LEAD CONNECTOR CAP K864738 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Jan 1987. https://www.510kdatabase.net/k864856/ 1987-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k864856-model-5866-24-pacemaker-lead-adaptor-fda-510k.jpg K864856 - MODEL 5866-24 PACEMAKER LEAD ADAPTOR K864856 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jan 1987. https://www.510kdatabase.net/k864211/ 1987-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k864211-il-test-97575-15-heparin-assay-fda-510k.jpg K864211 - IL TEST 97575-15, HEPARIN ASSAY K864211 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jan 1987. https://www.510kdatabase.net/k864224/ 1987-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k864224-abbott-spectrum-glucose-reagent-fda-510k.jpg K864224 - ABBOTT SPECTRUM GLUCOSE REAGENT K864224 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jan 1987. https://www.510kdatabase.net/k864481/ 1987-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k864481-coagulation-intrinsic-deficient-plasmas-fda-510k.jpg K864481 - COAGULATION INTRINSIC DEFICIENT PLASMAS K864481 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jan 1987. https://www.510kdatabase.net/k864497/ 1987-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k864497-coagulation-extrinsic-deficient-plasmas-fda-510k.jpg K864497 - COAGULATION EXTRINSIC DEFICIENT PLASMAS K864497 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jan 1987. https://www.510kdatabase.net/k864646/ 1987-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k864646-sorvall-capspin-microhematocrit-fda-510k.jpg K864646 - SORVALL CAPSPIN MICROHEMATOCRIT CENTRIFUGE K864646 is a FDA 510(k) cleared hematology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Jan 1987. https://www.510kdatabase.net/k862211/ 1987-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k862211-ultrasound-transducer-assembly-fda-510k.jpg K862211 - ULTRASOUND TRANSDUCER ASSEMBLY K862211 is a FDA 510(k) cleared radiology medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jan 1987. https://www.510kdatabase.net/k862459/ 1987-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k862459-modified-circuit-burn-in-process-fda-510k.jpg K862459 - MODIFIED CIRCUIT BURN-IN PROCESS IMPLANTABLE PULSE K862459 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jan 1987. https://www.510kdatabase.net/k863308/ 1987-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k863308-2200i-physiological-monitor-fda-510k.jpg K863308 - 2200I PHYSIOLOGICAL MONITOR K863308 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Jan 1987. https://www.510kdatabase.net/k864235/ 1987-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k864235-bardr-wm-harveyr-blood-oxygenatormodel-fda-510k.jpg K864235 - BARD(R) WM HARVEY(R) BLOOD OXYGENATOR/MODEL H-1600 K864235 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 1987. https://www.510kdatabase.net/k864262/ 1987-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k864262-arterial-2040-micron-filters-wwo-fda-510k.jpg K864262 - ARTERIAL 20/40 MICRON FILTERS W/WO HEPARIN COATING K864262 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jan 1987. https://www.510kdatabase.net/k864236/ 1986-12-31 monthly 0.5 https://www.510kdatabase.net/og-image/k864236-synchron-cx3-fda-510k.jpg K864236 - SYNCHRON CX3 K864236 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Dec 1986. https://www.510kdatabase.net/k864713/ 1986-12-31 monthly 0.5 https://www.510kdatabase.net/og-image/k864713-chloride-reagent-fda-510k.jpg K864713 - CHLORIDE REAGENT K864713 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Dec 1986. https://www.510kdatabase.net/k864715/ 1986-12-31 monthly 0.5 https://www.510kdatabase.net/og-image/k864715-easy-test-albumin-alb-item-no-6752993-fda-510k.jpg K864715 - EASY-TEST ALBUMIN (ALB), ITEM NO. 67529/93 K864715 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Dec 1986. https://www.510kdatabase.net/k864939/ 1986-12-31 monthly 0.5 https://www.510kdatabase.net/og-image/k864939-beckman-dri-stat-triglycerides-gpo-fda-510k.jpg K864939 - BECKMAN DRI-STAT TRIGLYCERIDES-GPO REAGENT KIT K864939 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Dec 1986. https://www.510kdatabase.net/k864264/ 1986-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k864264-tricotex-wound-contact-layer-dressing-fda-510k.jpg K864264 - TRICOTEX WOUND CONTACT LAYER DRESSING K864264 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Dec 1986. https://www.510kdatabase.net/k864788/ 1986-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k864788-exactech-total-hip-instruments-fda-510k.jpg K864788 - EXACTECH TOTAL HIP INSTRUMENTS K864788 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Dec 1986. https://www.510kdatabase.net/k864551/ 1986-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k864551-biopsy-adapter-h4221bg-fda-510k.jpg K864551 - BIOPSY ADAPTER #H4221BG K864551 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: General Electric Co.. Cleared Dec 1986. https://www.510kdatabase.net/k861856/ 1986-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k861856-nbp-488-tpr-488-fda-510k.jpg K861856 - NBP 488, TPR 488 K861856 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Dec 1986. https://www.510kdatabase.net/k862837/ 1986-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k862837-omnifit-total-knee-prosthesis-system-fda-510k.jpg K862837 - OMNIFIT TOTAL KNEE PROSTHESIS SYSTEM K862837 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Dec 1986. https://www.510kdatabase.net/k863967/ 1986-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k863967-specific-ige-fasttm-test-ii-fda-510k.jpg K863967 - SPECIFIC IGE FAST(TM) TEST II K863967 is a FDA 510(k) cleared immunology medical device. Manufacturer: 3M Company. Cleared Dec 1986. https://www.510kdatabase.net/k864531/ 1986-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k864531-tissue-gram-stain-fda-510k.jpg K864531 - TISSUE GRAM STAIN K864531 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Dec 1986. https://www.510kdatabase.net/k863668/ 1986-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k863668-omnifit-tm-total-knee-prosthesis-system-fda-510k.jpg K863668 - OMNIFIT (TM) TOTAL KNEE PROSTHESIS SYSTEM K863668 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Dec 1986. https://www.510kdatabase.net/k864350/ 1986-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k864350-vicryl-polyglactin-730-absorbable-fda-510k.jpg K864350 - VICRYL* POLYGLACTIN 730 ABSORBABLE STAPLES/STAPLER K864350 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Dec 1986. https://www.510kdatabase.net/k864403/ 1986-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k864403-monticelli-spinelli-external-fixation-fda-510k.jpg K864403 - MONTICELLI SPINELLI EXTERNAL FIXATION SYSTEM K864403 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Dec 1986. https://www.510kdatabase.net/k864633/ 1986-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k864633-vitallium-hex-drive-bone-screw-system-fda-510k.jpg K864633 - VITALLIUM HEX-DRIVE BONE SCREW SYSTEM K864633 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Dec 1986. https://www.510kdatabase.net/k860645/ 1986-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k860645-electrophoresis-data-center-edc-fda-510k.jpg K860645 - ELECTROPHORESIS DATA CENTER (EDC) K860645 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Dec 1986. https://www.510kdatabase.net/k864268/ 1986-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k864268-iq-triglycerides-fda-510k.jpg K864268 - IQ TRIGLYCERIDES K864268 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Dec 1986. https://www.510kdatabase.net/k864270/ 1986-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k864270-3m-glass-ionomer-liner-fda-510k.jpg K864270 - 3M GLASS IONOMER LINER K864270 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Dec 1986. https://www.510kdatabase.net/k864319/ 1986-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k864319-tdxr-ii-analyzer-fda-510k.jpg K864319 - TDX(R) II ANALYZER K864319 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Dec 1986. https://www.510kdatabase.net/k864341/ 1986-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k864341-iq-uric-acid-test-fda-510k.jpg K864341 - IQ URIC ACID TEST K864341 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Dec 1986. https://www.510kdatabase.net/k864435/ 1986-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k864435-visiontm-amylase-fda-510k.jpg K864435 - VISION(TM) AMYLASE K864435 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Dec 1986. https://www.510kdatabase.net/k864560/ 1986-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k864560-iq-t4-immunoassay-fda-510k.jpg K864560 - IQ T4 IMMUNOASSAY K864560 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Dec 1986. https://www.510kdatabase.net/k864629/ 1986-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k864629-modified-dual-lumen-needle-fda-510k.jpg K864629 - MODIFIED DUAL LUMEN NEEDLE K864629 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quinton, Inc.. Cleared Dec 1986. https://www.510kdatabase.net/k863667/ 1986-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k863667-modified-synatomic-knee-patella-fda-510k.jpg K863667 - MODIFIED SYNATOMIC KNEE PATELLA PROSTHESIS K863667 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Dec 1986. https://www.510kdatabase.net/k863997/ 1986-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k863997-abbott-lifecarer-4100-pca-infuser-fda-510k.jpg K863997 - ABBOTT LIFECARE(R) 4100 PCA INFUSER K863997 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Dec 1986. https://www.510kdatabase.net/k863960/ 1986-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k863960-stockert-shiley-caps-battery-module-fda-510k.jpg K863960 - STOCKERT-SHILEY CAPS BATTERY MODULE K863960 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Dec 1986. https://www.510kdatabase.net/k864027/ 1986-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k864027-bbl-campyslidetm-test-fda-510k.jpg K864027 - BBL CAMPYSLIDE(TM) TEST K864027 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Dec 1986. https://www.510kdatabase.net/k864149/ 1986-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k864149-q-scan-ii-and-q-scan-iii-fda-510k.jpg K864149 - Q-SCAN II AND Q-SCAN III K864149 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Dec 1986. https://www.510kdatabase.net/k864508/ 1986-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k864508-howse-ii-total-hip-replacement-system-fda-510k.jpg K864508 - HOWSE II TOTAL HIP REPLACEMENT SYSTEM K864508 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Dec 1986. https://www.510kdatabase.net/k860948/ 1986-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k860948-tracker-system-fda-510k.jpg K860948 - TRACKER SYSTEM K860948 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Dec 1986. https://www.510kdatabase.net/k863468/ 1986-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k863468-exactechtm-fda-510k.jpg K863468 - EXACTECH(TM) K863468 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Dec 1986. https://www.510kdatabase.net/k862463/ 1986-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k862463-lifescope-8-oec-8120-portable-patient-fda-510k.jpg K862463 - LIFESCOPE 8, OEC-8120 PORTABLE PATIENT MONITOR REC K862463 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Dec 1986. https://www.510kdatabase.net/k864428/ 1986-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k864428-model-366-23-adaptaidtm-step-down-fda-510k.jpg K864428 - MODEL 366-23 ADAPTAID(TM) STEP-DOWN ADAPTER K864428 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Dec 1986. https://www.510kdatabase.net/k864564/ 1986-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k864564-model-486-05-polyflexr-implantable-fda-510k.jpg K864564 - MODEL 486-05 POLYFLEX(R) IMPLANTABLE PACING LEAD K864564 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Dec 1986. https://www.510kdatabase.net/k861985/ 1986-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k861985-3m-brand-microvascular-anastomotic-fda-510k.jpg K861985 - 3M BRAND MICROVASCULAR ANASTOMOTIC COUPLER (27XX) K861985 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3M Company. Cleared Dec 1986. https://www.510kdatabase.net/k863928/ 1986-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k863928-terumo-sensibead-eia-fsh-kit-fda-510k.jpg K863928 - TERUMO SENSIBEAD EIA FSH KIT K863928 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Terumo Medical Corp.. Cleared Dec 1986. https://www.510kdatabase.net/k864082/ 1986-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k864082-reflotronr-alt-gpt-fda-510k.jpg K864082 - REFLOTRON(R) ALT (GPT) K864082 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Dec 1986. https://www.510kdatabase.net/k864212/ 1986-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k864212-il-test-97573-15-plasminogen-assay-fda-510k.jpg K864212 - IL TEST 97573-15, PLASMINOGEN ASSAY K864212 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Dec 1986. https://www.510kdatabase.net/k863794/ 1986-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k863794-3m-igg4-fast-test-package-fda-510k.jpg K863794 - 3M IGG4 FAST TEST PACKAGE K863794 is a FDA 510(k) cleared immunology medical device. Manufacturer: 3M Company. Cleared Dec 1986. https://www.510kdatabase.net/k863805/ 1986-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k863805-millergalante-total-knee-por-coated-fda-510k.jpg K863805 - MILLER/GALANTE TOTAL KNEE POR COATED PATELLAR DOME K863805 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Dec 1986. https://www.510kdatabase.net/k863288/ 1986-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k863288-hydrophilic-reprosil-fda-510k.jpg K863288 - HYDROPHILIC REPROSIL K863288 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Dec 1986. https://www.510kdatabase.net/k863750/ 1986-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k863750-hickmantm-subcutaneous-port-wdetached-fda-510k.jpg K863750 - HICKMAN(TM) SUBCUTANEOUS PORT W/DETACHED CATHETER K863750 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 1986. https://www.510kdatabase.net/k863930/ 1986-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k863930-viscopaste-zinc-paste-bandage-fda-510k.jpg K863930 - VISCOPASTE ZINC PASTE BANDAGE K863930 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Dec 1986. https://www.510kdatabase.net/k863931/ 1986-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k863931-carbonet-odour-adsorbing-dressing-fda-510k.jpg K863931 - CARBONET ODOUR ADSORBING DRESSING K863931 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Dec 1986. https://www.510kdatabase.net/k863962/ 1986-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k863962-emdstm-alanine-aminotransferase-alt-fda-510k.jpg K863962 - EMDS(TM) ALANINE AMINOTRANSFERASE (ALT) #67658/95 K863962 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Nov 1986. https://www.510kdatabase.net/k863963/ 1986-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k863963-emdstm-aspartate-aminotransferase-ast-fda-510k.jpg K863963 - EMDS(TM) ASPARTATE AMINOTRANSFERASE (AST) 67657/95 K863963 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Nov 1986. https://www.510kdatabase.net/k864230/ 1986-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k864230-dimension-tm-clinical-chemistry-system-fda-510k.jpg K864230 - DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM K864230 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Nov 1986. https://www.510kdatabase.net/k862744/ 1986-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k862744-teleradiography-system-fda-510k.jpg K862744 - TELERADIOGRAPHY SYSTEM K862744 is a FDA 510(k) cleared radiology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Nov 1986. https://www.510kdatabase.net/k862844/ 1986-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k862844-75-mhz-linear-probe-cat-no-h4221h-fda-510k.jpg K862844 - 7.5 MHZ LINEAR PROBE, CAT. NO. H4221H K862844 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Nov 1986. https://www.510kdatabase.net/k864041/ 1986-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k864041-emds-theophylline-testpacks-item-6766295-fda-510k.jpg K864041 - EMDS THEOPHYLLINE TESTPACKS ITEM #67662/95 K864041 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Nov 1986. https://www.510kdatabase.net/k864213/ 1986-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k864213-il-test-97572-15-alpha-2-antiplasmin-fda-510k.jpg K864213 - IL TEST 97572-15, ALPHA 2-ANTIPLASMIN ASSAY K864213 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Nov 1986. https://www.510kdatabase.net/k864214/ 1986-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k864214-il-test-97574-15m-antitthrombin-iii-fda-510k.jpg K864214 - IL TEST 97574-15M, ANTITTHROMBIN III ASSASY K864214 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Nov 1986. https://www.510kdatabase.net/k864271/ 1986-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k864271-il-test-84673-30-chromogenics-control-fda-510k.jpg K864271 - IL TEST 84673-30 CHROMOGENICS CONTROL PLASMA K864271 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Nov 1986. https://www.510kdatabase.net/k864372/ 1986-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k864372-osteonics-mc1-metal-back-acetabular-fda-510k.jpg K864372 - OSTEONICS MC1 METAL-BACK ACETABULAR CUP/PMMA SPACE K864372 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Nov 1986. https://www.510kdatabase.net/k863338/ 1986-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k863338-75-mhz-linear-small-parts-probe-fda-510k.jpg K863338 - 7.5 MHZ LINEAR SMALL PARTS PROBE K863338 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 1986. https://www.510kdatabase.net/k863751/ 1986-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k863751-multi-analyte-lin-trol-fda-510k.jpg K863751 - MULTI-ANALYTE LIN-TROL K863751 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Nov 1986. https://www.510kdatabase.net/k863901/ 1986-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k863901-iq-urea-nitrogen-fda-510k.jpg K863901 - IQ UREA NITROGEN K863901 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Nov 1986. https://www.510kdatabase.net/k864205/ 1986-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k864205-thermonuclease-agar-wtoluidine-blue-fda-510k.jpg K864205 - THERMONUCLEASE AGAR W/TOLUIDINE BLUE K864205 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Nov 1986. https://www.510kdatabase.net/k864208/ 1986-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k864208-vision-tm-ggtp-fda-510k.jpg K864208 - VISION (TM) GGTP K864208 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1986. https://www.510kdatabase.net/k860858/ 1986-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k860858-olympus-pf-18-pf-25-ultrathin-angioscope-fda-510k.jpg K860858 - OLYMPUS PF-18 & PF-25 ULTRATHIN ANGIOSCOPE K860858 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Olympus Corp.. Cleared Nov 1986. https://www.510kdatabase.net/k863030/ 1986-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k863030-630c-electrocardiograph-fda-510k.jpg K863030 - 630C ELECTROCARDIOGRAPH K863030 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Nov 1986. https://www.510kdatabase.net/k863138/ 1986-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k863138-terumo-radifocus-guide-wire-fda-510k.jpg K863138 - TERUMO RADIFOCUS GUIDE WIRE K863138 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Nov 1986. https://www.510kdatabase.net/k864002/ 1986-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k864002-model-431-06-polyflex-implantable-fda-510k.jpg K864002 - MODEL 431-06 POLYFLEX IMPLANTABLE PACING LEAD K864002 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Nov 1986. https://www.510kdatabase.net/k864287/ 1986-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k864287-model-430-05-polyflex-implantable-fda-510k.jpg K864287 - MODEL 430-05 POLYFLEX IMPLANTABLE PACING LEAD K864287 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Nov 1986. https://www.510kdatabase.net/k864338/ 1986-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k864338-secondary-set-lock-fda-510k.jpg K864338 - SECONDARY SET LOCK K864338 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Nov 1986. https://www.510kdatabase.net/k863541/ 1986-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k863541-stockert-shiley-caps-hlm-interface-fda-510k.jpg K863541 - STOCKERT-SHILEY CAPS HLM INTERFACE K863541 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Nov 1986. https://www.510kdatabase.net/k864307/ 1986-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k864307-max-i-probe-peridontalendodontic-fda-510k.jpg K864307 - MAX-I-PROBE PERIDONTAL/ENDODONTIC PROBE(TM) (MODI) K864307 is a FDA 510(k) cleared dental medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Nov 1986. https://www.510kdatabase.net/k863865/ 1986-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k863865-tensotape-surgical-adhesive-tape-fda-510k.jpg K863865 - TENSOTAPE SURGICAL ADHESIVE TAPE K863865 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Nov 1986. https://www.510kdatabase.net/k864013/ 1986-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k864013-model-q55xt-powered-treadmill-fda-510k.jpg K864013 - MODEL Q55XT POWERED TREADMILL K864013 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Quinton, Inc.. Cleared Nov 1986. https://www.510kdatabase.net/k862799/ 1986-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k862799-skin-pure-fda-510k.jpg K862799 - SKIN PURE K862799 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Nov 1986. https://www.510kdatabase.net/k863300/ 1986-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k863300-q101-diagnostic-spirometer-fda-510k.jpg K863300 - Q101 DIAGNOSTIC SPIROMETER K863300 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Quinton, Inc.. Cleared Nov 1986. https://www.510kdatabase.net/k863670/ 1986-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k863670-vision-tm-calcium-fda-510k.jpg K863670 - VISION (TM) CALCIUM K863670 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1986. https://www.510kdatabase.net/k863719/ 1986-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k863719-amylasecalciumchloride-triglycerides-fda-510k.jpg K863719 - AMYLASE,CALCIUM,CHLORIDE & TRIGLYCERIDES ON CHEM 1 K863719 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Nov 1986. https://www.510kdatabase.net/k863929/ 1986-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k863929-terumo-sensibeadtm-eia-hlh-kit-fda-510k.jpg K863929 - TERUMO SENSIBEAD(TM) EIA HLH KIT K863929 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Terumo Medical Corp.. Cleared Nov 1986. https://www.510kdatabase.net/k863948/ 1986-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k863948-a-genttm-liquid-glucose-trinder-fda-510k.jpg K863948 - A-GENT(TM) LIQUID GLUCOSE TRINDER K863948 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1986. https://www.510kdatabase.net/k864033/ 1986-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k864033-rapid-acid-fast-stain-fda-510k.jpg K864033 - RAPID ACID FAST STAIN K864033 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Nov 1986. https://www.510kdatabase.net/k864272/ 1986-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k864272-thromboplastinfs-fda-510k.jpg K864272 - THROMBOPLASTIN.FS K864272 is a FDA 510(k) cleared hematology medical device. Manufacturer: American Dade. Cleared Nov 1986. https://www.510kdatabase.net/k864273/ 1986-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k864273-thromboplastinc-fda-510k.jpg K864273 - THROMBOPLASTIN.C K864273 is a FDA 510(k) cleared hematology medical device. Manufacturer: American Dade. Cleared Nov 1986. https://www.510kdatabase.net/k864274/ 1986-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k864274-thromboplastinr-fda-510k.jpg K864274 - THROMBOPLASTIN.R K864274 is a FDA 510(k) cleared hematology medical device. Manufacturer: American Dade. Cleared Nov 1986. https://www.510kdatabase.net/k864130/ 1986-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k864130-abbott-b2-microglobulin-ria-fda-510k.jpg K864130 - ABBOTT B2-MICROGLOBULIN RIA K864130 is a FDA 510(k) cleared immunology medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1986. https://www.510kdatabase.net/k863041/ 1986-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k863041-35-mhz-sector-probe-model-8818098-lh306-fda-510k.jpg K863041 - 3.5 MHZ SECTOR PROBE, MODEL 8818098 LH306 K863041 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 1986. https://www.510kdatabase.net/k863043/ 1986-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k863043-35-mhz-sector-probe-model-8818080-lh-305-fda-510k.jpg K863043 - 3.5 MHZ SECTOR PROBE, MODEL 8818080 LH 305 K863043 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 1986. https://www.510kdatabase.net/k863096/ 1986-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k863096-5o-mhz-sector-probe-model-8818106-lh-307-fda-510k.jpg K863096 - 5.O MHZ SECTOR PROBE, MODEL 8818106 LH 307 K863096 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 1986. https://www.510kdatabase.net/k864137/ 1986-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k864137-lyphochek-immunoassay-serum-control-fda-510k.jpg K864137 - LYPHOCHEK IMMUNOASSAY SERUM CONTROL LEVEL I,II,III K864137 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Nov 1986. https://www.510kdatabase.net/k864167/ 1986-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k864167-percludertm-dl-occluding-fda-510k.jpg K864167 - PERCLUDER(TM)-DL OCCLUDING BALLOON(HEPARIN COATED) K864167 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Nov 1986. https://www.510kdatabase.net/k863475/ 1986-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k863475-theofasttm-test-package-fda-510k.jpg K863475 - THEOFAST(TM) TEST PACKAGE K863475 is a FDA 510(k) cleared chemistry medical device. Manufacturer: 3M Company. Cleared Nov 1986. https://www.510kdatabase.net/k863738/ 1986-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k863738-emdstm-creatininecrea-testpacks-6766995-fda-510k.jpg K863738 - EMDS(TM) CREATININE(CREA) TESTPACKS, #67669/95 K863738 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Nov 1986. https://www.510kdatabase.net/k863840/ 1986-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k863840-meth-cali-for-the-dimension-clinichem-fda-510k.jpg K863840 - METH. & CALI. FOR THE DIMENSION CLINI/CHEM. SYSTEM K863840 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Nov 1986. https://www.510kdatabase.net/k863887/ 1986-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k863887-smi-multipettortm-fda-510k.jpg K863887 - SMI MULTIPETTOR(TM) K863887 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Nov 1986. https://www.510kdatabase.net/k863888/ 1986-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k863888-du-pont-phenytoin-assay-and-calibrator-fda-510k.jpg K863888 - DU PONT PHENYTOIN ASSAY AND CALIBRATOR K863888 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Nov 1986. https://www.510kdatabase.net/k864102/ 1986-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k864102-ligaclip-2020-multiple-clip-applier-fda-510k.jpg K864102 - LIGACLIP 20/20* MULTIPLE CLIP APPLIER K864102 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Nov 1986. https://www.510kdatabase.net/k863172/ 1986-11-04 monthly 0.5 https://www.510kdatabase.net/og-image/k863172-respironics-ptl-reviveeasy-fda-510k.jpg K863172 - RESPIRONICS PTL REVIVEEASY K863172 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Nov 1986. https://www.510kdatabase.net/k862260/ 1986-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k862260-emit-chloramphenicol-assaybi-level-fda-510k.jpg K862260 - EMIT CHLORAMPHENICOL ASSAY/BI-LEVEL CONTROLS K862260 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Nov 1986. https://www.510kdatabase.net/k863781/ 1986-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k863781-model-493-08-polyflex-endocardial-lead-fda-510k.jpg K863781 - MODEL 493-08 POLYFLEX ENDOCARDIAL LEAD K863781 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Nov 1986. https://www.510kdatabase.net/k864047/ 1986-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k864047-model-366-28-adaptaidtm-step-down-fda-510k.jpg K864047 - MODEL 366-28 ADAPTAID(TM) STEP-DOWN ADAPTER K864047 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Nov 1986. https://www.510kdatabase.net/k864048/ 1986-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k864048-model-366-27-adaptaidtm-step-down-fda-510k.jpg K864048 - MODEL 366-27 ADAPTAID(TM) STEP-DOWN ADAPTER K864048 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Nov 1986. https://www.510kdatabase.net/k864141/ 1986-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k864141-cordis-contrast-injection-lines-fda-510k.jpg K864141 - CORDIS CONTRAST INJECTION LINES K864141 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Nov 1986. https://www.510kdatabase.net/k862451/ 1986-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k862451-luer-lock-skirt-fda-510k.jpg K862451 - LUER LOCK SKIRT K862451 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Oct 1986. https://www.510kdatabase.net/k862740/ 1986-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k862740-quinton-qcath-fda-510k.jpg K862740 - QUINTON Q.CATH K862740 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Oct 1986. https://www.510kdatabase.net/k862911/ 1986-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k862911-bi-plane-transrectal-probe-number-h4221t-fda-510k.jpg K862911 - BI-PLANE TRANSRECTAL PROBE NUMBER H4221T K862911 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Oct 1986. https://www.510kdatabase.net/k863404/ 1986-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k863404-cardiolife-tec-7100-fda-510k.jpg K863404 - CARDIOLIFE TEC 7100 K863404 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Oct 1986. https://www.510kdatabase.net/k863405/ 1986-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k863405-cardiolife-tec-7200-fda-510k.jpg K863405 - CARDIOLIFE TEC 7200 K863405 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Oct 1986. https://www.510kdatabase.net/k863537/ 1986-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k863537-cordis-reusable-inflation-device-for-fda-510k.jpg K863537 - CORDIS REUSABLE INFLATION DEVICE FOR ANGIOPLASTY K863537 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Oct 1986. https://www.510kdatabase.net/k863547/ 1986-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k863547-medtronic-model-5455-disposable-fda-510k.jpg K863547 - MEDTRONIC MODEL 5455 DISPOSABLE SURGICAL CABLE K863547 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Oct 1986. https://www.510kdatabase.net/k864077/ 1986-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k864077-candida-brom-cresol-green-agar-fda-510k.jpg K864077 - CANDIDA BROM CRESOL GREEN AGAR K864077 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1986. https://www.510kdatabase.net/k864078/ 1986-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k864078-modified-nyc-fermentation-medium-base-fda-510k.jpg K864078 - MODIFIED N.Y.C. FERMENTATION MEDIUM BASE K864078 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1986. https://www.510kdatabase.net/k864100/ 1986-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k864100-trycophyton-agars-fda-510k.jpg K864100 - TRYCOPHYTON AGARS K864100 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1986. https://www.510kdatabase.net/k864101/ 1986-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k864101-cook-r-vein-graft-ring-markers-fda-510k.jpg K864101 - COOK (R) VEIN GRAFT RING MARKERS K864101 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Oct 1986. https://www.510kdatabase.net/k863437/ 1986-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k863437-bard-balloon-dilatation-system-fda-510k.jpg K863437 - BARD BALLOON DILATATION SYSTEM K863437 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 1986. https://www.510kdatabase.net/k863478/ 1986-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k863478-cerebrospinal-fluid-protein-testpack-fda-510k.jpg K863478 - CEREBROSPINAL FLUID PROTEIN TESTPACK, #67668/95 K863478 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Oct 1986. https://www.510kdatabase.net/k863660/ 1986-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k863660-emds-uric-acid-urc-a-testpack-item-fda-510k.jpg K863660 - EMDS URIC ACID (URC A) TESTPACK, ITEM #67664/95 K863660 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Oct 1986. https://www.510kdatabase.net/k863718/ 1986-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k863718-emdstm-phosphorus-phos-testpacks-6767895-fda-510k.jpg K863718 - EMDS(TM) PHOSPHORUS (PHOS) TESTPACKS, #67678/95 K863718 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Oct 1986. https://www.510kdatabase.net/k863822/ 1986-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k863822-enzymun-testr-ige-fda-510k.jpg K863822 - ENZYMUN-TEST(R) IGE K863822 is a FDA 510(k) cleared immunology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Oct 1986. https://www.510kdatabase.net/k864074/ 1986-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k864074-elastic-stain-fda-510k.jpg K864074 - ELASTIC STAIN K864074 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Oct 1986. https://www.510kdatabase.net/k861433/ 1986-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k861433-universal-acetabular-component-fda-510k.jpg K861433 - UNIVERSAL ACETABULAR COMPONENT K861433 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Oct 1986. https://www.510kdatabase.net/k863286/ 1986-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k863286-ers-system-fda-510k.jpg K863286 - ERS SYSTEM K863286 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Oct 1986. https://www.510kdatabase.net/k863629/ 1986-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k863629-kodak-ektascan-laser-printer-model-100-fda-510k.jpg K863629 - KODAK EKTASCAN LASER PRINTER, MODEL 100 K863629 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Oct 1986. https://www.510kdatabase.net/k864008/ 1986-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k864008-acclaim-bracket-adhesive-fda-510k.jpg K864008 - ACCLAIM* BRACKET ADHESIVE K864008 is a FDA 510(k) cleared dental medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Oct 1986. https://www.510kdatabase.net/k864040/ 1986-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k864040-bard-eska-jonas-silicone-silver-penile-fda-510k.jpg K864040 - BARD ESKA JONAS SILICONE-SILVER PENILE PROSTHESIS K864040 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 1986. https://www.510kdatabase.net/k862561/ 1986-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k862561-technicon-ra-xt-system-with-analytes-fda-510k.jpg K862561 - TECHNICON RA-XT SYSTEM WITH ANALYTES K862561 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Oct 1986. https://www.510kdatabase.net/k863531/ 1986-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k863531-iq-immunochemistry-system-fda-510k.jpg K863531 - IQ IMMUNOCHEMISTRY SYSTEM K863531 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1986. https://www.510kdatabase.net/k863552/ 1986-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k863552-improved-comspan-fda-510k.jpg K863552 - IMPROVED COMSPAN K863552 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Oct 1986. https://www.510kdatabase.net/k863594/ 1986-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k863594-actin-fsl-activated-ptt-reagent-fda-510k.jpg K863594 - ACTIN FSL ACTIVATED PTT REAGENT K863594 is a FDA 510(k) cleared hematology medical device. Manufacturer: American Dade. Cleared Oct 1986. https://www.510kdatabase.net/k862631/ 1986-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k862631-bard-iryfixtm-stoma-cap-fda-510k.jpg K862631 - BARD IRYFIX(TM) STOMA CAP K862631 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 1986. https://www.510kdatabase.net/k863851/ 1986-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k863851-acid-phosphatase-acp-reagent-fda-510k.jpg K863851 - ACID PHOSPHATASE (ACP) REAGENT K863851 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Oct 1986. https://www.510kdatabase.net/k862234/ 1986-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k862234-exactech-total-hip-system-fda-510k.jpg K862234 - EXACTECH TOTAL HIP SYSTEM K862234 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Exactech, Inc.. Cleared Oct 1986. https://www.510kdatabase.net/k863171/ 1986-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k863171-respironics-protecteasy-fda-510k.jpg K863171 - RESPIRONICS PROTECTEASY K863171 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Oct 1986. https://www.510kdatabase.net/k863177/ 1986-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k863177-cordis-angioplasty-hemostasis-devices-fda-510k.jpg K863177 - CORDIS ANGIOPLASTY HEMOSTASIS DEVICES K863177 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Oct 1986. https://www.510kdatabase.net/k863628/ 1986-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k863628-c-reactive-protein-crp-for-technicon-fda-510k.jpg K863628 - C-REACTIVE PROTEIN (CRP), FOR TECHNICON RA SYSTEMS K863628 is a FDA 510(k) cleared immunology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Oct 1986. https://www.510kdatabase.net/k863137/ 1986-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k863137-terumo-radifocus-angiographic-catheter-fda-510k.jpg K863137 - TERUMO RADIFOCUS ANGIOGRAPHIC CATHETER K863137 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Oct 1986. https://www.510kdatabase.net/k863139/ 1986-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k863139-terumo-radifocus-introducer-kit-fda-510k.jpg K863139 - TERUMO RADIFOCUS INTRODUCER KIT K863139 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Oct 1986. https://www.510kdatabase.net/k863305/ 1986-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k863305-hickman-subcutaneous-port-wpre-fda-510k.jpg K863305 - HICKMAN SUBCUTANEOUS PORT W/PRE-ATTACHED CATHETER K863305 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 1986. https://www.510kdatabase.net/k863417/ 1986-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k863417-cordis-multicor-ii-model-402d-pacer-fda-510k.jpg K863417 - CORDIS MULTICOR II MODEL 402D PACER K863417 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Oct 1986. https://www.510kdatabase.net/k862317/ 1986-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k862317-ct-max-catalog-no-b7940-ha-fda-510k.jpg K862317 - CT MAX, CATALOG NO. B7940 HA K862317 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Oct 1986. https://www.510kdatabase.net/k863174/ 1986-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k863174-caulks-polishing-paste-fda-510k.jpg K863174 - CAULK'S POLISHING PASTE K863174 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Oct 1986. https://www.510kdatabase.net/k863683/ 1986-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k863683-bard-harvardtm-pca-jr-intermittent-fda-510k.jpg K863683 - BARD HARVARD(TM) PCA JR INTERMITTENT INFUSION PUMP K863683 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 1986. https://www.510kdatabase.net/k853770/ 1986-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k853770-codman-disposable-plastic-intracranial-fda-510k.jpg K853770 - CODMAN DISPOSABLE PLASTIC INTRACRANIAL PRESS/KIT K853770 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Oct 1986. https://www.510kdatabase.net/k863159/ 1986-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k863159-q4000-and-q3040-electrocardiograph-fda-510k.jpg K863159 - Q4000 AND Q3040 ELECTROCARDIOGRAPH MONITOR K863159 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Oct 1986. https://www.510kdatabase.net/k863331/ 1986-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k863331-siredoc-60-and-siredoc-220-fda-510k.jpg K863331 - SIREDOC 60 AND SIREDOC 220 K863331 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 1986. https://www.510kdatabase.net/k861255/ 1986-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k861255-behring-rapignost-total-screen-l-urine-fda-510k.jpg K861255 - BEHRING RAPIGNOST TOTAL SCREEN L URINE TEST STRIPS K861255 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Oct 1986. https://www.510kdatabase.net/k861263/ 1986-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k861263-behring-rapimat-ii-fda-510k.jpg K861263 - BEHRING RAPIMAT II K861263 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Oct 1986. https://www.510kdatabase.net/k863551/ 1986-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k863551-modified-medi-quet-tourniquet-model-fda-510k.jpg K863551 - MODIFIED MEDI-QUET TOURNIQUET, MODEL #2740-00 K863551 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Depuy, Inc.. Cleared Oct 1986. https://www.510kdatabase.net/k863622/ 1986-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k863622-tdxr-amylase-ii-fda-510k.jpg K863622 - TDX(R) AMYLASE II K863622 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1986. https://www.510kdatabase.net/k863330/ 1986-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k863330-disposable-pneumoperitoneum-needle-fda-510k.jpg K863330 - DISPOSABLE PNEUMOPERITONEUM NEEDLE K863330 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Oct 1986. https://www.510kdatabase.net/k863697/ 1986-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k863697-modified-silicone-dual-lumen-fda-510k.jpg K863697 - MODIFIED SILICONE DUAL LUMEN SUBCLAVIAN CANNULA K863697 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Shiley, Inc.. Cleared Oct 1986. https://www.510kdatabase.net/k862973/ 1986-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k862973-stockert-shiley-caps-timer-module-fda-510k.jpg K862973 - STOCKERT-SHILEY CAPS TIMER MODULE K862973 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Oct 1986. https://www.510kdatabase.net/k863487/ 1986-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k863487-quantimuner-ferritin-irma-fda-510k.jpg K863487 - QUANTIMUNE(R) FERRITIN IRMA K863487 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Oct 1986. https://www.510kdatabase.net/k863572/ 1986-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k863572-xanthinetyrosinecasein-agar-fda-510k.jpg K863572 - XANTHINE/TYROSINE/CASEIN AGAR K863572 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1986. https://www.510kdatabase.net/k863573/ 1986-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k863573-bird-seed-agar-fda-510k.jpg K863573 - BIRD SEED AGAR K863573 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1986. https://www.510kdatabase.net/k863599/ 1986-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k863599-starch-agar-wbrom-cresol-purple-fda-510k.jpg K863599 - STARCH AGAR W/BROM CRESOL PURPLE K863599 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1986. https://www.510kdatabase.net/k863600/ 1986-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k863600-motility-indole-lysine-sulfide-mils-fda-510k.jpg K863600 - MOTILITY INDOLE LYSINE SULFIDE (MILS) MEDIUM K863600 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1986. https://www.510kdatabase.net/k863601/ 1986-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k863601-onpg-solution-fda-510k.jpg K863601 - ONPG SOLUTION K863601 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1986. https://www.510kdatabase.net/k863602/ 1986-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k863602-buffered-glycerol-saline-fda-510k.jpg K863602 - BUFFERED GLYCEROL SALINE K863602 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1986. https://www.510kdatabase.net/k863603/ 1986-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k863603-gi-motility-test-medium-wttc-fda-510k.jpg K863603 - GI MOTILITY TEST MEDIUM W/TTC K863603 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1986. https://www.510kdatabase.net/k862148/ 1986-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k862148-olympus-au-5000-flame-photometer-module-fda-510k.jpg K862148 - OLYMPUS AU 5000 FLAME PHOTOMETER MODULE K862148 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Sep 1986. https://www.510kdatabase.net/k862920/ 1986-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k862920-bard-william-harvey-cardiotomy-reservoir-fda-510k.jpg K862920 - BARD WILLIAM HARVEY CARDIOTOMY RESERVOIR K862920 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Sep 1986. https://www.510kdatabase.net/k863240/ 1986-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k863240-prolactin-riabead-ii-diagnostic-kit-fda-510k.jpg K863240 - PROLACTIN RIABEAD II DIAGNOSTIC KIT K863240 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1986. https://www.510kdatabase.net/k863403/ 1986-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k863403-phenytoin-as-performed-on-technicon-ra-fda-510k.jpg K863403 - PHENYTOIN, AS PERFORMED ON TECHNICON RA SYSTEMS K863403 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Sep 1986. https://www.510kdatabase.net/k863419/ 1986-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k863419-emdstm-alcohol-testpacks-6769195-fda-510k.jpg K863419 - EMDS(TM) ALCOHOL TESTPACKS, #67691/95 K863419 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Sep 1986. https://www.510kdatabase.net/k863489/ 1986-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k863489-paramax-electrolyte-calibrator-fda-510k.jpg K863489 - PARAMAX ELECTROLYTE CALIBRATOR K863489 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Sep 1986. https://www.510kdatabase.net/k863528/ 1986-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k863528-bicondylar-toe-prosthesis-fda-510k.jpg K863528 - BICONDYLAR TOE PROSTHESIS K863528 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Sep 1986. https://www.510kdatabase.net/k863544/ 1986-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k863544-easy-test-carbon-dioxide-co2-item-fda-510k.jpg K863544 - EASY-TEST CARBON DIOXIDE (CO2) ITEM #67649/95 K863544 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Sep 1986. https://www.510kdatabase.net/k863328/ 1986-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k863328-acar-c-reactive-protein-crp-analytical-fda-510k.jpg K863328 - ACA(R) C-REACTIVE PROTEIN (CRP) ANALYTICAL TEST K863328 is a FDA 510(k) cleared immunology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Sep 1986. https://www.510kdatabase.net/k863329/ 1986-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k863329-acar-c-reactive-protein-crp-calibrator-fda-510k.jpg K863329 - ACA(R) C-REACTIVE PROTEIN (CRP) CALIBRATOR K863329 is a FDA 510(k) cleared immunology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Sep 1986. https://www.510kdatabase.net/k863477/ 1986-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k863477-emdstm-lactic-dehydrogenase-testpacks-fda-510k.jpg K863477 - EMDS(TM) LACTIC DEHYDROGENASE TESTPACKS, #67660/95 K863477 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Sep 1986. https://www.510kdatabase.net/k862879/ 1986-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k862879-new-light-curing-impression-material-fda-510k.jpg K862879 - NEW LIGHT-CURING IMPRESSION MATERIAL K862879 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Sep 1986. https://www.510kdatabase.net/k862955/ 1986-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k862955-methods-for-the-dimension-clinical-fda-510k.jpg K862955 - METHODS FOR THE DIMENSION CLINICAL CHEM. SYSTEM K862955 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Sep 1986. https://www.510kdatabase.net/k863088/ 1986-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k863088-abbott-spectrum-phosphorus-reagent-fda-510k.jpg K863088 - ABBOTT SPECTRUM PHOSPHORUS REAGENT K863088 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1986. https://www.510kdatabase.net/k863545/ 1986-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k863545-easy-test-lactic-dehydrogenase-ldh-fda-510k.jpg K863545 - EASY-TEST LACTIC DEHYDROGENASE (LDH) # 67527/95 K863545 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Sep 1986. https://www.510kdatabase.net/k863217/ 1986-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k863217-digilab-modular-one-applanation-fda-510k.jpg K863217 - DIGILAB MODULAR ONE-APPLANATION TONOMETER K863217 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Bio-Rad. Cleared Sep 1986. https://www.510kdatabase.net/k863418/ 1986-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k863418-model-352-01-silicone-rubber-isolation-fda-510k.jpg K863418 - MODEL 352-01 SILICONE RUBBER ISOLATION SLEEVE K863418 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Sep 1986. https://www.510kdatabase.net/k862975/ 1986-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k862975-modified-ptca-guiding-catheters-fda-510k.jpg K862975 - MODIFIED PTCA GUIDING CATHETERS K862975 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Sep 1986. https://www.510kdatabase.net/k863037/ 1986-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k863037-usci-r-disposable-inflation-device-fda-510k.jpg K863037 - USCI (R) DISPOSABLE INFLATION DEVICE K863037 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Sep 1986. https://www.510kdatabase.net/k863307/ 1986-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k863307-tenzcare-snap-electrode-no-6865-fda-510k.jpg K863307 - TENZCARE SNAP ELECTRODE, NO. 6865 K863307 is a FDA 510(k) cleared neurology medical device. Manufacturer: 3M Company. Cleared Sep 1986. https://www.510kdatabase.net/k862053/ 1986-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k862053-model-432-01-biopore-implantable-fda-510k.jpg K862053 - MODEL 432-01 BIOPORE IMPLANTABLE PACING LEAD K862053 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Sep 1986. https://www.510kdatabase.net/k862054/ 1986-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k862054-model-430-01-biopore-implantable-fda-510k.jpg K862054 - MODEL 430-01 BIOPORE IMPLANTABLE PACING LEAD K862054 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Sep 1986. https://www.510kdatabase.net/k862151/ 1986-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k862151-color-flow-mapping-cfm-option-model-fda-510k.jpg K862151 - COLOR FLOW MAPPING (CFM) OPTION - MODEL 77020 CF K862151 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Sep 1986. https://www.510kdatabase.net/k863092/ 1986-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k863092-dental-composite-restorative-fda-510k.jpg K863092 - DENTAL COMPOSITE RESTORATIVE K863092 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Sep 1986. https://www.510kdatabase.net/k863322/ 1986-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k863322-modified-mahurkar-subclavian-femoral-fda-510k.jpg K863322 - MODIFIED MAHURKAR SUBCLAVIAN & FEMORAL CATHETERS K863322 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Sep 1986. https://www.510kdatabase.net/k863519/ 1986-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k863519-cal-cellobiose-arginine-lysine-agar-fda-510k.jpg K863519 - CAL (CELLOBIOSE-ARGININE-LYSINE) AGAR K863519 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1986. https://www.510kdatabase.net/k863522/ 1986-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k863522-modified-self-cure-bonding-agent-fda-510k.jpg K863522 - MODIFIED SELF-CURE BONDING AGENT K863522 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Sep 1986. https://www.510kdatabase.net/k863523/ 1986-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k863523-toc-tween-80-oxgall-caffeic-acid-agar-fda-510k.jpg K863523 - TOC (TWEEN 80 - OXGALL-CAFFEIC ACID) AGAR K863523 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1986. https://www.510kdatabase.net/k863524/ 1986-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k863524-regan-lowe-charcoal-agar-fda-510k.jpg K863524 - REGAN-LOWE CHARCOAL AGAR K863524 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1986. https://www.510kdatabase.net/k863525/ 1986-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k863525-dermatophyte-test-medium-slants-and-fda-510k.jpg K863525 - DERMATOPHYTE TEST MEDIUM, SLANTS AND MYCOFLASKS K863525 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1986. https://www.510kdatabase.net/k863526/ 1986-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k863526-yep-yeast-extract-phosphate-agar-fda-510k.jpg K863526 - YEP (YEAST EXTRACT PHOSPHATE) AGAR K863526 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1986. https://www.510kdatabase.net/k863527/ 1986-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k863527-cary-blair-transport-medium-fda-510k.jpg K863527 - CARY-BLAIR TRANSPORT MEDIUM K863527 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1986. https://www.510kdatabase.net/k863116/ 1986-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k863116-cardiofax-ecg-6551-electrocardiogrph-fda-510k.jpg K863116 - CARDIOFAX ECG-6551 (ELECTROCARDIOGRPH) K863116 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Sep 1986. https://www.510kdatabase.net/k863129/ 1986-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k863129-3m-corneal-system-corneal-preservation-fda-510k.jpg K863129 - 3M CORNEAL SYSTEM (CORNEAL PRESERVATION MEDIUM) K863129 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: 3M Company. Cleared Sep 1986. https://www.510kdatabase.net/k863203/ 1986-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k863203-cholinesterase-btc-reagent-fda-510k.jpg K863203 - CHOLINESTERASE (BTC) REAGENT K863203 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Sep 1986. https://www.510kdatabase.net/k863226/ 1986-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k863226-albumin-bcp-fda-510k.jpg K863226 - ALBUMIN (BCP) K863226 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Sep 1986. https://www.510kdatabase.net/k863352/ 1986-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k863352-precimat-r-iga-g-m-fda-510k.jpg K863352 - PRECIMAT (R) IGA, G, M K863352 is a FDA 510(k) cleared immunology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Sep 1986. https://www.510kdatabase.net/k862371/ 1986-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k862371-hemoglobin-a1c-by-column-test-micro-a1c-fda-510k.jpg K862371 - HEMOGLOBIN A1C BY COLUMN TEST (MICRO A1C) K862371 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bio-Rad. Cleared Sep 1986. https://www.510kdatabase.net/k862429/ 1986-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k862429-abbott-rsv-eia-fda-510k.jpg K862429 - ABBOTT RSV EIA K862429 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1986. https://www.510kdatabase.net/k863003/ 1986-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k863003-emdstm-calcium-testpacks-6768795-fda-510k.jpg K863003 - EMDS(TM) CALCIUM TESTPACKS, #67687/95 K863003 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Sep 1986. https://www.510kdatabase.net/k863004/ 1986-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k863004-emdstm-albumin-testpacks-6765295-fda-510k.jpg K863004 - EMDS(TM) ALBUMIN TESTPACKS, #67652/95 K863004 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Sep 1986. https://www.510kdatabase.net/k863099/ 1986-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k863099-abbott-testpack-tm-acute-hep-a-control-fda-510k.jpg K863099 - ABBOTT TESTPACK (TM) ACUTE HEP A CONTROL KIT K863099 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1986. https://www.510kdatabase.net/k863202/ 1986-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k863202-cholinesterase-ptc-reagent-fda-510k.jpg K863202 - CHOLINESTERASE (PTC) REAGENT K863202 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Sep 1986. https://www.510kdatabase.net/k863032/ 1986-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k863032-abbott-testpack-tm-hcg-serum-fda-510k.jpg K863032 - ABBOTT TESTPACK (TM) HCG SERUM K863032 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1986. https://www.510kdatabase.net/k863126/ 1986-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k863126-testpack-acute-hcg-serum-controls-fda-510k.jpg K863126 - TESTPACK ACUTE HCG SERUM CONTROLS K863126 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1986. https://www.510kdatabase.net/k863127/ 1986-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k863127-testpack-acute-hcg-uringe-controls-fda-510k.jpg K863127 - TESTPACK ACUTE HCG URINGE CONTROLS K863127 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1986. https://www.510kdatabase.net/k863191/ 1986-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k863191-bactec-13a-medium-7h13-fda-510k.jpg K863191 - BACTEC 13A MEDIUM (7H13) K863191 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1986. https://www.510kdatabase.net/k862836/ 1986-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k862836-stockert-shiley-caps-and-caps-dual-fda-510k.jpg K862836 - STOCKERT-SHILEY CAPS AND CAPS DUAL PRESSURE MODULE K862836 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Sep 1986. https://www.510kdatabase.net/k862673/ 1986-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k862673-model-6615-floscan-doppler-diagnostic-fda-510k.jpg K862673 - MODEL 6615 FLOSCAN DOPPLER DIAGNOSTIC CATHETER K862673 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Sep 1986. https://www.510kdatabase.net/k863299/ 1986-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k863299-modified-q50-medical-treadmill-fda-510k.jpg K863299 - MODIFIED Q50 MEDICAL TREADMILL K863299 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Quinton, Inc.. Cleared Sep 1986. https://www.510kdatabase.net/k860830/ 1986-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k860830-technicon-h1-system-t-lymphocytes-method-fda-510k.jpg K860830 - TECHNICON H.1 SYSTEM, T LYMPHOCYTES METHOD K860830 is a FDA 510(k) cleared hematology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Sep 1986. https://www.510kdatabase.net/k862593/ 1986-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k862593-das-211-fda-510k.jpg K862593 - DAS 211 K862593 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Sep 1986. https://www.510kdatabase.net/k862762/ 1986-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k862762-tina-quantr-igm-fda-510k.jpg K862762 - TINA-QUANT(R) IGM K862762 is a FDA 510(k) cleared immunology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Sep 1986. https://www.510kdatabase.net/k860237/ 1986-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k860237-omf-7101-fetal-monitor-fda-510k.jpg K860237 - OMF-7101 FETAL MONITOR K860237 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Sep 1986. https://www.510kdatabase.net/k860353/ 1986-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k860353-syringe-infusion-pump-fda-510k.jpg K860353 - SYRINGE INFUSION PUMP K860353 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Sep 1986. https://www.510kdatabase.net/k863303/ 1986-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k863303-model-617d-fda-510k.jpg K863303 - MODEL 617D K863303 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Sep 1986. https://www.510kdatabase.net/k863324/ 1986-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k863324-triad-impact-fda-510k.jpg K863324 - TRIAD IMPACT K863324 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Sep 1986. https://www.510kdatabase.net/k862374/ 1986-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k862374-cellect-8e-automated-blood-cell-counters-fda-510k.jpg K862374 - CELLECT 8E AUTOMATED BLOOD CELL COUNTERS K862374 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 1986. https://www.510kdatabase.net/k862763/ 1986-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k862763-tina-quantr-iga-fda-510k.jpg K862763 - TINA-QUANT(R) IGA K862763 is a FDA 510(k) cleared immunology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Sep 1986. https://www.510kdatabase.net/k862974/ 1986-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k862974-alternate-package-config-for-implant-fda-510k.jpg K862974 - ALTERNATE PACKAGE CONFIG. FOR IMPLANT. PULSE GEN. K862974 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Sep 1986. https://www.510kdatabase.net/k863290/ 1986-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k863290-il-cellect-7-fda-510k.jpg K863290 - IL CELLECT 7 K863290 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 1986. https://www.510kdatabase.net/k863291/ 1986-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k863291-il-cellect-8-fda-510k.jpg K863291 - IL CELLECT 8 K863291 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 1986. https://www.510kdatabase.net/k862301/ 1986-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k862301-il-system-810-acl-and-the-reagent-sets-fda-510k.jpg K862301 - IL SYSTEM 810, ACL AND THE REAGENT SETS K862301 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 1986. https://www.510kdatabase.net/k862764/ 1986-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k862764-tina-quantr-igg-fda-510k.jpg K862764 - TINA-QUANT(R) IGG K862764 is a FDA 510(k) cleared immunology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Sep 1986. https://www.510kdatabase.net/k862535/ 1986-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k862535-osteonics-shoulder-prosthesis-fda-510k.jpg K862535 - OSTEONICS SHOULDER PROSTHESIS K862535 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Sep 1986. https://www.510kdatabase.net/k862689/ 1986-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k862689-25mm-hex-drivercurve-passerbone-fda-510k.jpg K862689 - 2.5MM HEX DRIVER/CURVE PASSER/BONE PUNCH/RASP K862689 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Sep 1986. https://www.510kdatabase.net/k861708/ 1986-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k861708-solid-state-detector-computerized-fda-510k.jpg K861708 - SOLID STATE DETECTOR COMPUTERIZED TOMOGRAPHIC K861708 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Aug 1986. https://www.510kdatabase.net/k862466/ 1986-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k862466-schneider-shiley-flushing-catheter-fda-510k.jpg K862466 - SCHNEIDER-SHILEY FLUSHING CATHETER K862466 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Aug 1986. https://www.510kdatabase.net/k862845/ 1986-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k862845-emds-tm-hdl-cholesterol-item-no-6767995-fda-510k.jpg K862845 - EMDS (TM) HDL CHOLESTEROL ITEM NO. 67679/95 K862845 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Aug 1986. https://www.510kdatabase.net/k862905/ 1986-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k862905-alp-opt-reagent-fda-510k.jpg K862905 - ALP (OPT) REAGENT K862905 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Aug 1986. https://www.510kdatabase.net/k863005/ 1986-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k863005-emdstm-total-protein-testpacks-6766395-fda-510k.jpg K863005 - EMDS(TM) TOTAL PROTEIN TESTPACKS, #67663/95 K863005 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Aug 1986. https://www.510kdatabase.net/k863094/ 1986-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k863094-systemate-tm-alanine-transferase-alt-fda-510k.jpg K863094 - SYSTEMATE (TM) ALANINE TRANSFERASE (ALT) K863094 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Aug 1986. https://www.510kdatabase.net/k861761/ 1986-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k861761-accessus-dry-storage-package-sterile-fda-510k.jpg K861761 - ACCESSUS DRY STORAGE PACKAGE STERILE COMP STORAGE K861761 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Aug 1986. https://www.510kdatabase.net/k862464/ 1986-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k862464-schneider-shiley-y-connector-with-fda-510k.jpg K862464 - SCHNEIDER-SHILEY Y-CONNECTOR WITH ROTATOR K862464 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Aug 1986. https://www.510kdatabase.net/k854944/ 1986-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k854944-tdx-immunoglobulin-m-diagnostic-kit-fda-510k.jpg K854944 - TDX IMMUNOGLOBULIN M DIAGNOSTIC KIT K854944 is a FDA 510(k) cleared immunology medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1986. https://www.510kdatabase.net/k855046/ 1986-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k855046-tdx-immunoglobulin-a-diagnostic-kit-fda-510k.jpg K855046 - TDX IMMUNOGLOBULIN A DIAGNOSTIC KIT K855046 is a FDA 510(k) cleared immunology medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1986. https://www.510kdatabase.net/k861386/ 1986-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k861386-kodak-ektachem-clinical-chemistry-fda-510k.jpg K861386 - KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (MG) K861386 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Aug 1986. https://www.510kdatabase.net/k861414/ 1986-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k861414-electrophoresis-work-center-ewc-fda-510k.jpg K861414 - ELECTROPHORESIS WORK CENTER (EWC) K861414 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Aug 1986. https://www.510kdatabase.net/k863196/ 1986-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k863196-bun-rate-reagent-fda-510k.jpg K863196 - BUN (RATE) REAGENT K863196 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Aug 1986. https://www.510kdatabase.net/k854607/ 1986-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k854607-acculevel-phenobarbital-test-fda-510k.jpg K854607 - ACCULEVEL PHENOBARBITAL TEST K854607 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Aug 1986. https://www.510kdatabase.net/k861538/ 1986-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k861538-860-color-doppler-or-colorview-860-fda-510k.jpg K861538 - 860 COLOR DOPPLER OR COLORVIEW 860 K861538 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Aug 1986. https://www.510kdatabase.net/k862244/ 1986-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k862244-modifications-to-cordis-super-flow-fda-510k.jpg K862244 - MODIFICATIONS TO CORDIS' SUPER FLOW CATHETERS K862244 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Aug 1986. https://www.510kdatabase.net/k862971/ 1986-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k862971-micra-microsurgical-instruments-fda-510k.jpg K862971 - MICRA MICROSURGICAL INSTRUMENTS K862971 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cordis Corp.. Cleared Aug 1986. https://www.510kdatabase.net/k854662/ 1986-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k854662-oee7102-eegtrend-monitor-fda-510k.jpg K854662 - OEE_7102 EEG/TREND MONITOR K854662 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Aug 1986. https://www.510kdatabase.net/k854663/ 1986-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k854663-neurofax-7310-series-eeg-fda-510k.jpg K854663 - NEUROFAX 7310 SERIES (EEG) K854663 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Aug 1986. https://www.510kdatabase.net/k860009/ 1986-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k860009-50-mhz-meridian-ultrasound-imaging-fda-510k.jpg K860009 - 5.0 MHZ MERIDIAN ULTRASOUND IMAGING SYSTEM K860009 is a FDA 510(k) cleared radiology medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Aug 1986. https://www.510kdatabase.net/k861970/ 1986-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k861970-lyphochek-urine-toxicology-control-fda-510k.jpg K861970 - LYPHOCHEK URINE TOXICOLOGY CONTROL K861970 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bio-Rad. Cleared Aug 1986. https://www.510kdatabase.net/k862108/ 1986-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k862108-enzymun-test-hcg-fda-510k.jpg K862108 - ENZYMUN-TEST HCG K862108 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Aug 1986. https://www.510kdatabase.net/k862288/ 1986-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k862288-modification-of-tissue-dilator-fda-510k.jpg K862288 - MODIFICATION OF TISSUE DILATOR K862288 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Aug 1986. https://www.510kdatabase.net/k862359/ 1986-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k862359-methcaliintru-check-for-the-dimension-fda-510k.jpg K862359 - METH./CALI./INTRU. CHECK FOR THE DIMENSION SYSTEM K862359 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Aug 1986. https://www.510kdatabase.net/k862428/ 1986-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k862428-stratus-tsh-fluorometric-enzyme-fda-510k.jpg K862428 - STRATUS TSH FLUOROMETRIC ENZYME IMMUNOASSAY K862428 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Aug 1986. https://www.510kdatabase.net/k862453/ 1986-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k862453-emds-theophylline-calibrators-item-no-fda-510k.jpg K862453 - EMDS THEOPHYLLINE CALIBRATORS ITEM NO. 67---/93 K862453 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Aug 1986. https://www.510kdatabase.net/k862525/ 1986-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k862525-emdstm-dichrome-qc-test-solution-item-fda-510k.jpg K862525 - EMDS(TM) DICHROME QC TEST SOLUTION ITEM # 67447/95 K862525 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Aug 1986. https://www.510kdatabase.net/k862603/ 1986-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k862603-double-antibody-estradiol-ria-kit-fda-510k.jpg K862603 - DOUBLE ANTIBODY ESTRADIOL RIA KIT K862603 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Aug 1986. https://www.510kdatabase.net/k862701/ 1986-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k862701-surespot-fda-510k.jpg K862701 - SURESPOT K862701 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Aug 1986. https://www.510kdatabase.net/k862704/ 1986-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k862704-emdstm-elevated-bilirubin-calibrator-fda-510k.jpg K862704 - EMDS(TM) ELEVATED BILIRUBIN CALIBRATOR # 67627/95 K862704 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Aug 1986. https://www.510kdatabase.net/k862706/ 1986-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k862706-emdstm-triglyceride-testpacks-6767495-fda-510k.jpg K862706 - EMDS(TM) TRIGLYCERIDE TESTPACKS #67674/95 K862706 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Aug 1986. https://www.510kdatabase.net/k862707/ 1986-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k862707-emdstm-cholesterol-testpack-6768595-fda-510k.jpg K862707 - EMDS(TM) CHOLESTEROL TESTPACK, # 67685/95 K862707 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Aug 1986. https://www.510kdatabase.net/k862818/ 1986-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k862818-stratus-ferritin-fluorometric-enzyme-fda-510k.jpg K862818 - STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY K862818 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Aug 1986. https://www.510kdatabase.net/k863002/ 1986-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k863002-emdstm-magnesium-testpacks-6767195-fda-510k.jpg K863002 - EMDS(TM) MAGNESIUM TESTPACKS, #67671/95 K863002 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Aug 1986. https://www.510kdatabase.net/k862202/ 1986-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k862202-visiontm-hemoglobin-fda-510k.jpg K862202 - VISION(TM) HEMOGLOBIN K862202 is a FDA 510(k) cleared hematology medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1986. https://www.510kdatabase.net/k854664/ 1986-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k854664-meb-5200-fda-510k.jpg K854664 - MEB-5200 K854664 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Aug 1986. https://www.510kdatabase.net/k862800/ 1986-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k862800-smx-generator-fda-510k.jpg K862800 - SMX GENERATOR K862800 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Aug 1986. https://www.510kdatabase.net/k861844/ 1986-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k861844-glucofacts-data-management-system-fda-510k.jpg K861844 - GLUCOFACTS DATA MANAGEMENT SYSTEM K861844 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Aug 1986. https://www.510kdatabase.net/k862944/ 1986-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k862944-kodak-cft-film-so-141-fda-510k.jpg K862944 - KODAK CFT FILM SO-141 K862944 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Aug 1986. https://www.510kdatabase.net/k862465/ 1986-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k862465-schneider-shiley-occluderflushing-cath-fda-510k.jpg K862465 - SCHNEIDER-SHILEY OCCLUDER/FLUSHING CATH. STOPCOCK K862465 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Aug 1986. https://www.510kdatabase.net/k862467/ 1986-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k862467-schneider-shiley-seldinger-initial-fda-510k.jpg K862467 - SCHNEIDER-SHILEY SELDINGER INITIAL PUNCTURE INSTR K862467 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Aug 1986. https://www.510kdatabase.net/k861779/ 1986-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k861779-glucofacts-data-printer-fda-510k.jpg K861779 - GLUCOFACTS DATA PRINTER K861779 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Aug 1986. https://www.510kdatabase.net/k832422/ 1986-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k832422-cordis-ancor-active-fixation-lead-fda-510k.jpg K832422 - CORDIS ANCOR ACTIVE FIXATION LEAD K832422 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Aug 1986. https://www.510kdatabase.net/k851064/ 1986-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k851064-cordis-hi-flex-pervenous-active-fda-510k.jpg K851064 - CORDIS HI-FLEX PERVENOUS ACTIVE FIXATION UNIPOLAR K851064 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Aug 1986. https://www.510kdatabase.net/k861368/ 1986-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k861368-medtronic-model-5328-programmable-fda-510k.jpg K861368 - MEDTRONIC MODEL 5328 PROGRAMMABLE STIMULATOR K861368 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Aug 1986. https://www.510kdatabase.net/k862185/ 1986-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k862185-lyphochek-pediatric-and-bilirubin-fda-510k.jpg K862185 - LYPHOCHEK PEDIATRIC AND BILIRUBIN CONTROL K862185 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Aug 1986. https://www.510kdatabase.net/k862440/ 1986-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k862440-paramax-lipase-reagent-fda-510k.jpg K862440 - PARAMAX LIPASE REAGENT K862440 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Aug 1986. https://www.510kdatabase.net/k862703/ 1986-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k862703-emdstm-elevated-lipid-calibrator-6762695-fda-510k.jpg K862703 - EMDS(TM) ELEVATED LIPID CALIBRATOR #67626/95 K862703 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Aug 1986. https://www.510kdatabase.net/k862761/ 1986-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k862761-vacutainer-brand-agar-slant-fda-510k.jpg K862761 - VACUTAINER BRAND AGAR SLANT K862761 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1986. https://www.510kdatabase.net/k862513/ 1986-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k862513-external-ventricular-lumbar-drainage-fda-510k.jpg K862513 - EXTERNAL VENTRICULAR & LUMBAR DRAINAGE SETS K862513 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cordis Corp.. Cleared Aug 1986. https://www.510kdatabase.net/k861931/ 1986-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k861931-645ob-sectorlinear-ultrasound-scanner-fda-510k.jpg K861931 - 645OB SECTOR/LINEAR ULTRASOUND SCANNER K861931 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Jul 1986. https://www.510kdatabase.net/k862660/ 1986-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k862660-prisma-metal-opaquers-fda-510k.jpg K862660 - PRISMA METAL OPAQUERS K862660 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jul 1986. https://www.510kdatabase.net/k861358/ 1986-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k861358-ps-system-with-sd-200-doppler-fda-510k.jpg K861358 - PS SYSTEM WITH SD-200 DOPPLER K861358 is a FDA 510(k) cleared radiology medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jul 1986. https://www.510kdatabase.net/k862656/ 1986-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k862656-pacemaker-lead-adapter-fda-510k.jpg K862656 - PACEMAKER LEAD ADAPTER K862656 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Jul 1986. https://www.510kdatabase.net/k862702/ 1986-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k862702-tri-lock-ii-titanium-acetabulum-fda-510k.jpg K862702 - TRI-LOCK II TITANIUM ACETABULUM PROSTHESIS K862702 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jul 1986. https://www.510kdatabase.net/k861786/ 1986-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k861786-du-pont-drug-calibrator-fda-510k.jpg K861786 - DU PONT DRUG CALIBRATOR K861786 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Jul 1986. https://www.510kdatabase.net/k861792/ 1986-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k861792-twin-got-ast-ifccgpt-alt-ifcc-fda-510k.jpg K861792 - TWIN GOT-AST IFCC/GPT-ALT IFCC K861792 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jul 1986. https://www.510kdatabase.net/k862253/ 1986-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k862253-il-482-co-oximeter-fda-510k.jpg K862253 - IL 482 CO-OXIMETER K862253 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jul 1986. https://www.510kdatabase.net/k862274/ 1986-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k862274-analyst-analytical-test-rotors-fda-510k.jpg K862274 - ANALYST ANALYTICAL TEST ROTORS K862274 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Jul 1986. https://www.510kdatabase.net/k862652/ 1986-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k862652-emit-valproic-acid-assay-fda-510k.jpg K862652 - EMIT VALPROIC ACID ASSAY K862652 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jul 1986. https://www.510kdatabase.net/k862682/ 1986-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k862682-mvp-generator-catalog-no-h8018-fda-510k.jpg K862682 - MVP GENERATOR, CATALOG NO. H8018 K862682 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jul 1986. https://www.510kdatabase.net/k862741/ 1986-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k862741-q50-medical-treadmill-fda-510k.jpg K862741 - Q50 MEDICAL TREADMILL K862741 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Quinton, Inc.. Cleared Jul 1986. https://www.510kdatabase.net/k860163/ 1986-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k860163-bicondylar-toe-prosthesis-fda-510k.jpg K860163 - BICONDYLAR TOE PROSTHESIS K860163 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jul 1986. https://www.510kdatabase.net/k860697/ 1986-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k860697-ultrasound-imaging-system-model-280-sl-fda-510k.jpg K860697 - ULTRASOUND IMAGING SYSTEM MODEL 280 SL K860697 is a FDA 510(k) cleared radiology medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jul 1986. https://www.510kdatabase.net/k861266/ 1986-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k861266-howmedica-kinematic-plus-knee-system-fda-510k.jpg K861266 - HOWMEDICA KINEMATIC PLUS KNEE SYSTEM K861266 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jul 1986. https://www.510kdatabase.net/k861737/ 1986-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k861737-meridian-imaging-system-fda-510k.jpg K861737 - MERIDIAN IMAGING SYSTEM K861737 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jul 1986. https://www.510kdatabase.net/k862611/ 1986-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k862611-sterile-disposable-trocar-sleeve-devices-fda-510k.jpg K862611 - STERILE DISPOSABLE TROCAR-SLEEVE DEVICES K862611 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Jul 1986. https://www.510kdatabase.net/k862452/ 1986-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k862452-mx-mobile-x-ray-system-fda-510k.jpg K862452 - MX MOBILE X-RAY SYSTEM K862452 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Jul 1986. https://www.510kdatabase.net/k862590/ 1986-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k862590-3m-esthetic-design-system-tints-fda-510k.jpg K862590 - 3M ESTHETIC DESIGN SYSTEM (TINTS & MASKING AGENTS) K862590 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Jul 1986. https://www.510kdatabase.net/k861363/ 1986-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k861363-enzygnost-anti-cmv-igm-test-fda-510k.jpg K861363 - ENZYGNOST ANTI-CMV IGM TEST K861363 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Jul 1986. https://www.510kdatabase.net/k861544/ 1986-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k861544-model-80225a-obstetrical-management-fda-510k.jpg K861544 - MODEL 80225A OBSTETRICAL MANAGEMENT SYSTEM K861544 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Jul 1986. https://www.510kdatabase.net/k862019/ 1986-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k862019-ics-apolipoprotein-a-1-reagent-test-kit-fda-510k.jpg K862019 - ICS APOLIPOPROTEIN A-1 REAGENT TEST KIT K862019 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jul 1986. https://www.510kdatabase.net/k862386/ 1986-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k862386-ics-apolipoprotein-b-reagent-test-kit-fda-510k.jpg K862386 - ICS APOLIPOPROTEIN B REAGENT TEST KIT K862386 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jul 1986. https://www.510kdatabase.net/k861390/ 1986-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k861390-depth-measuring-needlesvascu-implant-fda-510k.jpg K861390 - DEPTH MEASURING NEEDLES/VASCU IMPLANT ACCESS SET K861390 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jul 1986. https://www.510kdatabase.net/k862510/ 1986-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k862510-stockert-shiley-caps-4-channel-temp-fda-510k.jpg K862510 - STOCKERT-SHILEY CAPS 4 CHANNEL TEMP. MONITOR 1 K862510 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Jul 1986. https://www.510kdatabase.net/k861714/ 1986-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k861714-stockert-shiley-multiflow-roller-pump-fda-510k.jpg K861714 - STOCKERT-SHILEY MULTIFLOW ROLLER PUMP MODULE K861714 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Jul 1986. https://www.510kdatabase.net/k862116/ 1986-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k862116-stockert-shiley-double-head-pump-module-fda-510k.jpg K862116 - STOCKERT-SHILEY DOUBLE HEAD PUMP MODULE K862116 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Jul 1986. https://www.510kdatabase.net/k862326/ 1986-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k862326-porous-coated-hip-femoral-prosthesis-fda-510k.jpg K862326 - POROUS COATED HIP FEMORAL PROSTHESIS K862326 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jul 1986. https://www.510kdatabase.net/k861618/ 1986-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k861618-travasorb-feeding-tubes-2l8014-and-fda-510k.jpg K861618 - TRAVASORB FEEDING TUBES - (2L8014) AND (2L8024) K861618 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Jul 1986. https://www.510kdatabase.net/k860309/ 1986-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k860309-hemafluor-reagent-kit-fda-510k.jpg K860309 - HEMAFLUOR REAGENT KIT K860309 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Jul 1986. https://www.510kdatabase.net/k860815/ 1986-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k860815-solid-phase-boil-dualcount-dualcount-spb-fda-510k.jpg K860815 - SOLID PHASE BOIL DUALCOUNT (DUALCOUNT SPB) K860815 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jul 1986. https://www.510kdatabase.net/k861831/ 1986-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k861831-reflotron-uric-acid-fda-510k.jpg K861831 - REFLOTRON URIC ACID K861831 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jul 1986. https://www.510kdatabase.net/k862250/ 1986-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k862250-tdx-benzodiazepines-fda-510k.jpg K862250 - TDX BENZODIAZEPINES K862250 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Jul 1986. https://www.510kdatabase.net/k862298/ 1986-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k862298-alternate-size-e-z-pace-electrode-fda-510k.jpg K862298 - ALTERNATE SIZE E-Z-PACE ELECTRODE K862298 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jul 1986. https://www.510kdatabase.net/k862595/ 1986-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k862595-kodak-m35a-x-omat-processor-fda-510k.jpg K862595 - KODAK M35A X-OMAT PROCESSOR K862595 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Jul 1986. https://www.510kdatabase.net/k861861/ 1986-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k861861-515a-neo-trak-neonatal-monitor-fda-510k.jpg K861861 - 515A NEO-TRAK NEONATAL MONITOR K861861 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Jul 1986. https://www.510kdatabase.net/k862257/ 1986-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k862257-model-431-02-biopore-implantable-fda-510k.jpg K862257 - MODEL 431-02 BIOPORE IMPLANTABLE PACING LEAD K862257 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Jul 1986. https://www.510kdatabase.net/k862258/ 1986-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k862258-model-437-01-biopore-implantable-fda-510k.jpg K862258 - MODEL 437-01 BIOPORE IMPLANTABLE PACING LEAD K862258 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Jul 1986. https://www.510kdatabase.net/k862259/ 1986-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k862259-model-433-01-biopore-implantable-fda-510k.jpg K862259 - MODEL 433-01 BIOPORE IMPLANTABLE PACING LEAD K862259 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Jul 1986. https://www.510kdatabase.net/k862443/ 1986-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k862443-medtronic-temporary-and-implantable-fda-510k.jpg K862443 - MEDTRONIC TEMPORARY AND IMPLANTABLE PACING LEADS K862443 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jul 1986. https://www.510kdatabase.net/k861710/ 1986-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k861710-model-ust-ssd-880l1-5-tranesophageal-fda-510k.jpg K861710 - MODEL UST-SSD 880L1-5 TRANESOPHAGEAL PHASED ARRAY K861710 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jul 1986. https://www.510kdatabase.net/k861833/ 1986-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k861833-restor-cometdental-restorative-fda-510k.jpg K861833 - RESTOR (COMET)*DENTAL RESTORATIVE K861833 is a FDA 510(k) cleared dental medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jul 1986. https://www.510kdatabase.net/k862163/ 1986-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k862163-johnson-johnson-petrolatum-gauze-non-fda-510k.jpg K862163 - JOHNSON & JOHNSON PETROLATUM GAUZE NON ADHER DRESS K862163 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jul 1986. https://www.510kdatabase.net/k860356/ 1986-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k860356-orthoblend-powered-bone-mill-fda-510k.jpg K860356 - ORTHOBLEND POWERED BONE MILL K860356 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jul 1986. https://www.510kdatabase.net/k861766/ 1986-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k861766-howmedica-hoffmann-fixation-pin-system-fda-510k.jpg K861766 - HOWMEDICA HOFFMANN FIXATION PIN SYSTEM K861766 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jul 1986. https://www.510kdatabase.net/k860123/ 1986-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k860123-50-mhz-intraoperative-array-fda-510k.jpg K860123 - 5.0 MHZ INTRAOPERATIVE ARRAY K860123 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 1986. https://www.510kdatabase.net/k861741/ 1986-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k861741-tdx-rea-lactic-acid-fda-510k.jpg K861741 - TDX REA LACTIC ACID K861741 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jul 1986. https://www.510kdatabase.net/k862308/ 1986-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k862308-easy-test-tm-emit-phenobarbital-fda-510k.jpg K862308 - EASY-TEST (TM) EMIT* PHENOBARBITAL (PHNO)/67534/93 K862308 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jul 1986. https://www.510kdatabase.net/k862319/ 1986-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k862319-hbdh-optimized-reagent-fda-510k.jpg K862319 - HBDH (OPTIMIZED) REAGENT K862319 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Jul 1986. https://www.510kdatabase.net/k862349/ 1986-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k862349-easy-test-emit-phenytoinphtn-item-fda-510k.jpg K862349 - EASY-TEST EMIT PHENYTOIN(PHTN) ITEM # 67535/93 K862349 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jul 1986. https://www.510kdatabase.net/k862350/ 1986-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k862350-easy-test-emit-theophyllinetheo-item-fda-510k.jpg K862350 - EASY-TEST EMIT* THEOPHYLLINE(THEO) ITEM 67533/93 K862350 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jul 1986. https://www.510kdatabase.net/k861228/ 1986-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k861228-75-mhz-linear-probe-ultrasonic-fda-510k.jpg K861228 - 7.5 MHZ LINEAR PROBE (ULTRASONIC TRANSDUCER) K861228 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jul 1986. https://www.510kdatabase.net/k862052/ 1986-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k862052-model-438-01-cardifix-implantable-fda-510k.jpg K862052 - MODEL 438-01 CARDIFIX IMPLANTABLE PACING LEAD K862052 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Jul 1986. https://www.510kdatabase.net/k851639/ 1986-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k851639-anti-leu-12-b-cell-reagent-fda-510k.jpg K851639 - ANTI-LEU-12 B CELL REAGENT K851639 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jul 1986. https://www.510kdatabase.net/k855202/ 1986-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k855202-glucometer-m-blood-gulcose-meter-fda-510k.jpg K855202 - GLUCOMETER M BLOOD GULCOSE METER K855202 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Jul 1986. https://www.510kdatabase.net/k861303/ 1986-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k861303-glucometer-ii-improved-reflectance-fda-510k.jpg K861303 - GLUCOMETER II IMPROVED REFLECTANCE PHOTOMETER K861303 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Jul 1986. https://www.510kdatabase.net/k861778/ 1986-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k861778-clinifacts-200-data-management-system-fda-510k.jpg K861778 - CLINIFACTS 200 DATA MANAGEMENT SYSTEM K861778 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Jul 1986. https://www.510kdatabase.net/k862276/ 1986-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k862276-model-435-02-cardifix-implantable-fda-510k.jpg K862276 - MODEL 435-02 CARDIFIX IMPLANTABLE PACING LEAD K862276 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Jul 1986. https://www.510kdatabase.net/k860210/ 1986-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k860210-elefix-electrode-cream-fda-510k.jpg K860210 - ELEFIX ELECTRODE CREAM K860210 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Jul 1986. https://www.510kdatabase.net/k861314/ 1986-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k861314-cholesterol-calibrators-fda-510k.jpg K861314 - CHOLESTEROL CALIBRATORS K861314 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Jul 1986. https://www.510kdatabase.net/k861384/ 1986-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k861384-non-adhering-dressing-with-povidone-fda-510k.jpg K861384 - NON-ADHERING DRESSING WITH POVIDONE-IODINE K861384 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jul 1986. https://www.510kdatabase.net/k861696/ 1986-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k861696-electrolyte-analyzer-accessory-for-fda-510k.jpg K861696 - ELECTROLYTE ANALYZER ACCESSORY FOR HITACHI 704 K861696 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jul 1986. https://www.510kdatabase.net/k861719/ 1986-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k861719-modified-models-832083228329831683178318-fda-510k.jpg K861719 - MODIFIED MODELS 8320/8322/8329/8316/8317/8318 K861719 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jul 1986. https://www.510kdatabase.net/k862186/ 1986-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k862186-lyphochek-glycated-hemoglobinwhole-fda-510k.jpg K862186 - LYPHOCHEK GLYCATED HEMOGLOBIN/WHOLE BLOOD/LEV.I&II K862186 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bio-Rad. Cleared Jul 1986. https://www.510kdatabase.net/k853565/ 1986-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k853565-artis-ultrasound-imaging-system-fda-510k.jpg K853565 - ARTIS ULTRASOUND IMAGING SYSTEM K853565 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Jun 1986. https://www.510kdatabase.net/k862109/ 1986-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k862109-enzymun-test-tbg-fda-510k.jpg K862109 - ENZYMUN TEST TBG K862109 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jun 1986. https://www.510kdatabase.net/k861387/ 1986-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k861387-kodak-ektachem-clinical-chemistry-fda-510k.jpg K861387 - KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CK-MB) K861387 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Jun 1986. https://www.510kdatabase.net/k861680/ 1986-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k861680-osteonics-elbow-prosthesis-fda-510k.jpg K861680 - OSTEONICS ELBOW PROSTHESIS K861680 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Jun 1986. https://www.510kdatabase.net/k861775/ 1986-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k861775-twin-bunglucose-fda-510k.jpg K861775 - TWIN BUN/GLUCOSE K861775 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jun 1986. https://www.510kdatabase.net/k861793/ 1986-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k861793-twin-triglycerides-gpocholesterol-fda-510k.jpg K861793 - TWIN TRIGLYCERIDES GPO/CHOLESTEROL K861793 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jun 1986. https://www.510kdatabase.net/k862006/ 1986-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k862006-stand-high-flow-femoral-ventricular-fda-510k.jpg K862006 - STAND & HIGH FLOW FEMORAL-VENTRICULAR PIGTAIL CATH K862006 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Jun 1986. https://www.510kdatabase.net/k862125/ 1986-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k862125-arizona-condylar-tibial-plateau-fda-510k.jpg K862125 - ARIZONA CONDYLAR TIBIAL PLATEAU K862125 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jun 1986. https://www.510kdatabase.net/k862214/ 1986-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k862214-emit-quinidine-assay-fda-510k.jpg K862214 - EMIT QUINIDINE ASSAY K862214 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jun 1986. https://www.510kdatabase.net/k862218/ 1986-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k862218-double-antibody-cocaine-metabolite-ria-fda-510k.jpg K862218 - DOUBLE ANTIBODY COCAINE METABOLITE RIA KIT K862218 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jun 1986. https://www.510kdatabase.net/k860239/ 1986-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k860239-org-7201-multiparameter-telemetry-fda-510k.jpg K860239 - ORG-7201 MULTIPARAMETER TELEMETRY MONITOR K860239 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Jun 1986. https://www.510kdatabase.net/k860846/ 1986-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k860846-cordis-hi-flex-pervenous-bipolar-lead-fda-510k.jpg K860846 - CORDIS HI-FLEX PERVENOUS BIPOLAR LEAD K860846 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Jun 1986. https://www.510kdatabase.net/k860136/ 1986-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k860136-bard-parker-carotid-shunt-fda-510k.jpg K860136 - BARD-PARKER CAROTID SHUNT K860136 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jun 1986. https://www.510kdatabase.net/k861274/ 1986-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k861274-double-antibody-calcitonin-ria-kit-fda-510k.jpg K861274 - DOUBLE ANTIBODY CALCITONIN RIA KIT K861274 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jun 1986. https://www.510kdatabase.net/k861899/ 1986-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k861899-scotchbond-light-cured-dental-adhesive-fda-510k.jpg K861899 - SCOTCHBOND LIGHT CURED DENTAL ADHESIVE W/FLUORIDE K861899 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Jun 1986. https://www.510kdatabase.net/k861377/ 1986-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k861377-standardpediatric-cordis-hydrocephalus-fda-510k.jpg K861377 - STANDARD/PEDIATRIC CORDIS HYDROCEPHALUS VALVES K861377 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cordis Corp.. Cleared Jun 1986. https://www.510kdatabase.net/k861573/ 1986-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k861573-terumo-sensibead-eia-tsh-kit-fda-510k.jpg K861573 - TERUMO SENSIBEAD EIA TSH KIT K861573 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Terumo Medical Corp.. Cleared Jun 1986. https://www.510kdatabase.net/k861776/ 1986-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k861776-high-efficiency-hemodialysis-system-fda-510k.jpg K861776 - HIGH EFFICIENCY HEMODIALYSIS SYSTEM K861776 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Jun 1986. https://www.510kdatabase.net/k860464/ 1986-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k860464-vision-theophylline-addit-of-whole-fda-510k.jpg K860464 - VISION THEOPHYLLINE - ADDIT. OF WHOLE BLOOD CLAIM K860464 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1986. https://www.510kdatabase.net/k860681/ 1986-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k860681-disposable-flush-device-fda-510k.jpg K860681 - DISPOSABLE FLUSH DEVICE K860681 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Jun 1986. https://www.510kdatabase.net/k861400/ 1986-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k861400-threaded-titanium-metal-backed-fda-510k.jpg K861400 - THREADED TITANIUM METAL BACKED ACETABULAR CUP K861400 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jun 1986. https://www.510kdatabase.net/k861798/ 1986-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k861798-vision-total-protein-fda-510k.jpg K861798 - VISION TOTAL PROTEIN K861798 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1986. https://www.510kdatabase.net/k862037/ 1986-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k862037-modify-labelpasys-mod-83161718-implan-fda-510k.jpg K862037 - MODIFY LABEL/PASYS & MOD 8316/17/18 IMPLAN PUL GEN K862037 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jun 1986. https://www.510kdatabase.net/k862038/ 1986-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k862038-modify-labelspectrax-s-sx-implant-fda-510k.jpg K862038 - MODIFY LABEL/SPECTRAX S & SX IMPLANT PULSE GENER K862038 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jun 1986. https://www.510kdatabase.net/k862071/ 1986-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k862071-modified-label-forspectrax-sxt-implant-fda-510k.jpg K862071 - MODIFIED LABEL FOR/SPECTRAX SXT IMPLANT. PULSE GEN K862071 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jun 1986. https://www.510kdatabase.net/k862138/ 1986-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k862138-vision-albumin-fda-510k.jpg K862138 - VISION ALBUMIN K862138 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1986. https://www.510kdatabase.net/k861187/ 1986-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k861187-sceptor-gram-negative-breakpoint-id-fda-510k.jpg K861187 - SCEPTOR GRAM NEGATIVE BREAKPOINT /ID PANEL K861187 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jun 1986. https://www.510kdatabase.net/k861920/ 1986-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k861920-simultrac-neonatal-t457cotsh125i-fda-510k.jpg K861920 - SIMULTRAC NEONATAL T4(57CO)/TSH(125I) RADIOIMMUNO. K861920 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jun 1986. https://www.510kdatabase.net/k862067/ 1986-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k862067-stratus-digitoxin-fluorometric-enzyme-fda-510k.jpg K862067 - STRATUS DIGITOXIN FLUOROMETRIC ENZYME IMMUNOASSAY K862067 is a FDA 510(k) cleared toxicology medical device. Manufacturer: American Dade. Cleared Jun 1986. https://www.510kdatabase.net/k862120/ 1986-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k862120-scx-system-fda-510k.jpg K862120 - SCX SYSTEM K862120 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jun 1986. https://www.510kdatabase.net/k862152/ 1986-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k862152-tissue-culture-flask-pl-732-plastic-fda-510k.jpg K862152 - TISSUE CULTURE FLASK PL 732 PLASTIC ACCESSORY PROD K862152 is a FDA 510(k) cleared pathology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Jun 1986. https://www.510kdatabase.net/k853872/ 1986-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k853872-emit-caffeine-assay-fda-510k.jpg K853872 - EMIT CAFFEINE ASSAY K853872 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jun 1986. https://www.510kdatabase.net/k853989/ 1986-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k853989-cor-dot-cmv-fda-510k.jpg K853989 - COR DOT CMV K853989 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Cordis Corp.. Cleared Jun 1986. https://www.510kdatabase.net/k860547/ 1986-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k860547-model-486-02-endocardial-pacing-lead-fda-510k.jpg K860547 - MODEL 486-02 ENDOCARDIAL PACING LEAD K860547 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Jun 1986. https://www.510kdatabase.net/k860548/ 1986-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k860548-model-492-02-endocardial-pacing-lead-fda-510k.jpg K860548 - MODEL 492-02 ENDOCARDIAL PACING LEAD K860548 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Jun 1986. https://www.510kdatabase.net/k861186/ 1986-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k861186-sceptor-gram-positive-breakpointid-panel-fda-510k.jpg K861186 - SCEPTOR GRAM POSITIVE BREAKPOINT/ID PANEL K861186 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jun 1986. https://www.510kdatabase.net/k861392/ 1986-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k861392-syva-solid-phase-columns-system-ii-fda-510k.jpg K861392 - SYVA SOLID PHASE COLUMNS SYSTEM II K861392 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Jun 1986. https://www.510kdatabase.net/k861498/ 1986-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k861498-medtronic-model-8501-access-port-fda-510k.jpg K861498 - MEDTRONIC MODEL 8501 ACCESS PORT K861498 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medtronic Vascular. Cleared Jun 1986. https://www.510kdatabase.net/k861700/ 1986-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k861700-dimension-tm-clinical-chemistry-system-fda-510k.jpg K861700 - DIMENSION (TM) CLINICAL CHEMISTRY SYSTEM K861700 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Jun 1986. https://www.510kdatabase.net/k861819/ 1986-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k861819-kodak-ektachem-clinical-chemistry-fda-510k.jpg K861819 - KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CREA) K861819 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Jun 1986. https://www.510kdatabase.net/k860549/ 1986-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k860549-du-pont-c-reactive-protein-crp-fda-510k.jpg K860549 - DU PONT C-REACTIVE PROTEIN (CRP) CALIBRATOR K860549 is a FDA 510(k) cleared immunology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Jun 1986. https://www.510kdatabase.net/k860550/ 1986-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k860550-du-pont-c-reactive-protein-crp-assay-fda-510k.jpg K860550 - DU PONT C-REACTIVE PROTEIN (CRP) ASSAY K860550 is a FDA 510(k) cleared immunology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Jun 1986. https://www.510kdatabase.net/k861606/ 1986-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k861606-schneider-shiley-wire-torquer-fda-510k.jpg K861606 - SCHNEIDER-SHILEY WIRE TORQUER K861606 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Jun 1986. https://www.510kdatabase.net/k861607/ 1986-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k861607-schneider-shiley-inflation-syringes-fda-510k.jpg K861607 - SCHNEIDER-SHILEY INFLATION SYRINGES K861607 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Jun 1986. https://www.510kdatabase.net/k861723/ 1986-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k861723-modified-omnifit-threaded-acetabular-fda-510k.jpg K861723 - (MODIFIED) OMNIFIT THREADED ACETABULAR COMPONENT K861723 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Jun 1986. https://www.510kdatabase.net/k861992/ 1986-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k861992-model-43200a-cardiac-monitor-fda-510k.jpg K861992 - MODEL 43200A CARDIAC MONITOR K861992 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Jun 1986. https://www.510kdatabase.net/k854665/ 1986-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k854665-4312p-polysomnograph-electoenciphalograp-fda-510k.jpg K854665 - 4312P POLYSOMNOGRAPH ELECTOENCIPHALOGRAPH K854665 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Jun 1986. https://www.510kdatabase.net/k860164/ 1986-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k860164-2500-printer-fda-510k.jpg K860164 - 2500 PRINTER K860164 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Jun 1986. https://www.510kdatabase.net/k860233/ 1986-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k860233-5-mhz-intracavitary-probe-model-h4222v-fda-510k.jpg K860233 - 5 MHZ INTRACAVITARY PROBE, MODEL H4222V K860233 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: General Electric Co.. Cleared Jun 1986. https://www.510kdatabase.net/k861310/ 1986-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k861310-stockert-shiley-aortic-root-cannulae-fda-510k.jpg K861310 - STOCKERT-SHILEY AORTIC ROOT CANNULAE K861310 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared May 1986. https://www.510kdatabase.net/k860906/ 1986-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k860906-stratus-immunoassay-controls-levels-i-fda-510k.jpg K860906 - STRATUS IMMUNOASSAY CONTROLS, LEVELS I, II, III K860906 is a FDA 510(k) cleared toxicology medical device. Manufacturer: American Dade. Cleared May 1986. https://www.510kdatabase.net/k861048/ 1986-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k861048-prekallikrein-deficient-plasma-cat-no-fda-510k.jpg K861048 - PREKALLIKREIN DEFICIENT PLASMA, CAT. NO. B 6765 K861048 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Chemical Co.. Cleared May 1986. https://www.510kdatabase.net/k861049/ 1986-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k861049-high-molecular-weight-kininogenhmwk-fda-510k.jpg K861049 - HIGH MOLECULAR WEIGHT KININOGEN(HMWK) DEF PLASMA K861049 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Chemical Co.. Cleared May 1986. https://www.510kdatabase.net/k861367/ 1986-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k861367-kodak-ektachem-clinical-chemistry-fda-510k.jpg K861367 - KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (THEO) K861367 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared May 1986. https://www.510kdatabase.net/k861393/ 1986-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k861393-emit-column-digoxin-assay-fda-510k.jpg K861393 - EMIT COLUMN DIGOXIN ASSAY K861393 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared May 1986. https://www.510kdatabase.net/k861394/ 1986-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k861394-emit-digoxin-mobile-phase-solution-fda-510k.jpg K861394 - EMIT DIGOXIN MOBILE PHASE SOLUTION K861394 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared May 1986. https://www.510kdatabase.net/k861750/ 1986-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k861750-ckld-buffer-cat-no-5808-fda-510k.jpg K861750 - CK/LD BUFFER (CAT. NO. 5808) K861750 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared May 1986. https://www.510kdatabase.net/k861835/ 1986-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k861835-microtrak-neiserria-gonorrhoeae-fda-510k.jpg K861835 - MICROTRAK NEISERRIA GONORRHOEAE CULTURE TEST K861835 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Syva Co.. Cleared May 1986. https://www.510kdatabase.net/k861177/ 1986-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k861177-capiox-iii-cardiopulmonary-bypass-fda-510k.jpg K861177 - CAPIOX III CARDIOPULMONARY BYPASS OXYGENATOR K861177 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared May 1986. https://www.510kdatabase.net/k861605/ 1986-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k861605-schneider-shiley-pressure-manometer-fda-510k.jpg K861605 - SCHNEIDER-SHILEY PRESSURE MANOMETER K861605 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared May 1986. https://www.510kdatabase.net/k861496/ 1986-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k861496-stockert-shiley-venous-cath-aortic-fda-510k.jpg K861496 - STOCKERT-SHILEY VENOUS CATH & AORTIC ARCH CANNULA K861496 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared May 1986. https://www.510kdatabase.net/k860935/ 1986-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k860935-emds-amylase-amyl-test-packs-6765395-fda-510k.jpg K860935 - EMDS AMYLASE (AMYL) TEST PACKS, # 67653/95 K860935 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared May 1986. https://www.510kdatabase.net/k861412/ 1986-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k861412-direct-readout-module-accessory-fda-510k.jpg K861412 - DIRECT READOUT MODULE ACCESSORY K861412 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared May 1986. https://www.510kdatabase.net/k861467/ 1986-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k861467-albumin-bcg-reagent-fda-510k.jpg K861467 - ALBUMIN (BCG) REAGENT K861467 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared May 1986. https://www.510kdatabase.net/k861512/ 1986-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k861512-emds-ckck-mb-verifier-item-number-67-95-fda-510k.jpg K861512 - EMDS, CK/CK-MB VERIFIER, ITEM NUMBER 67---/95 K861512 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared May 1986. https://www.510kdatabase.net/k861567/ 1986-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k861567-control-sera-level-values-mgdl-fda-510k.jpg K861567 - CONTROL SERA LEVEL VALUES (MG/DL) K861567 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared May 1986. https://www.510kdatabase.net/k860920/ 1986-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k860920-stockert-shiley-heatercooler-fda-510k.jpg K860920 - STOCKERT-SHILEY HEATER/COOLER TEMPERATURE CONTROL K860920 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared May 1986. https://www.510kdatabase.net/k861583/ 1986-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k861583-co2-laser-bronchoscope-system-fda-510k.jpg K861583 - CO2 LASER BRONCHOSCOPE SYSTEM K861583 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared May 1986. https://www.510kdatabase.net/k861740/ 1986-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k861740-p-50-light-cured-resin-bonded-ceramic-fda-510k.jpg K861740 - P-50 LIGHT CURED RESIN BONDED CERAMIC K861740 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared May 1986. https://www.510kdatabase.net/k861007/ 1986-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k861007-becton-dickinson-pcainfuser-fda-510k.jpg K861007 - BECTON DICKINSON PCAINFUSER K861007 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared May 1986. https://www.510kdatabase.net/k854299/ 1986-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k854299-gore-tex-periodontal-material-fda-510k.jpg K854299 - GORE-TEX PERIODONTAL MATERIAL K854299 is a FDA 510(k) cleared dental medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared May 1986. https://www.510kdatabase.net/k855045/ 1986-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k855045-model-535-neo-trak-recorder-fda-510k.jpg K855045 - MODEL 535 NEO-TRAK RECORDER K855045 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared May 1986. https://www.510kdatabase.net/k861359/ 1986-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k861359-cardiac-monitor-cardiotachometer-and-fda-510k.jpg K861359 - CARDIAC MONITOR, CARDIOTACHOMETER AND ALARM K861359 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared May 1986. https://www.510kdatabase.net/k861478/ 1986-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k861478-bard-double-pigtail-ureteral-stent-fda-510k.jpg K861478 - BARD DOUBLE PIGTAIL URETERAL STENT K861478 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 1986. https://www.510kdatabase.net/k861407/ 1986-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k861407-neo-trak-502-infant-monitor-fda-510k.jpg K861407 - NEO-TRAK 502 INFANT MONITOR K861407 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared May 1986. https://www.510kdatabase.net/k860768/ 1986-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k860768-directigen-combo-meningitis-test-fda-510k.jpg K860768 - DIRECTIGEN COMBO MENINGITIS TEST K860768 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared May 1986. https://www.510kdatabase.net/k855107/ 1986-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k855107-medtronic-model-3422a-transmitter-fda-510k.jpg K855107 - MEDTRONIC MODEL 3422A TRANSMITTER ANTENNA KIT K855107 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared May 1986. https://www.510kdatabase.net/k860652/ 1986-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k860652-ultrasound-transducer-21230a-75mhz-fda-510k.jpg K860652 - ULTRASOUND TRANSDUCER #21230A 7.5MHZ SHORT FOCUS K860652 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared May 1986. https://www.510kdatabase.net/k861395/ 1986-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k861395-emit-column-digoxin-calibrators-fda-510k.jpg K861395 - EMIT COLUMN DIGOXIN CALIBRATORS K861395 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared May 1986. https://www.510kdatabase.net/k860442/ 1986-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k860442-precision-hip-system-proximal-femoral-fda-510k.jpg K860442 - PRECISION HIP SYSTEM PROXIMAL FEMORAL SPACER #6259 K860442 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared May 1986. https://www.510kdatabase.net/k861461/ 1986-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k861461-shiley-sleep-apnea-cuffless-fda-510k.jpg K861461 - SHILEY SLEEP APNEA CUFFLESS FENESTRATED TRACH TUBE K861461 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shiley, Inc.. Cleared May 1986. https://www.510kdatabase.net/k861462/ 1986-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k861462-shiley-sleep-apnea-cuffless-fda-510k.jpg K861462 - SHILEY SLEEP APNEA CUFFLESS TRACHEOSTOMY TUBE K861462 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shiley, Inc.. Cleared May 1986. https://www.510kdatabase.net/k861463/ 1986-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k861463-shiley-sleep-apnea-low-pressure-cuffed-fda-510k.jpg K861463 - SHILEY SLEEP APNEA LOW PRESSURE CUFFED TRACH TUBE K861463 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shiley, Inc.. Cleared May 1986. https://www.510kdatabase.net/k861490/ 1986-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k861490-permaclear-solution-cat-no-4950-fda-510k.jpg K861490 - PERMACLEAR SOLUTION CAT. NO. 4950 K861490 is a FDA 510(k) cleared pathology medical device. Manufacturer: Helena Laboratories. Cleared May 1986. https://www.510kdatabase.net/k860465/ 1986-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k860465-vision-sgot-ast-addit-of-whole-blood-fda-510k.jpg K860465 - VISION SGOT (AST) - ADDIT. OF WHOLE BLOOD CLAIM K860465 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared May 1986. https://www.510kdatabase.net/k861082/ 1986-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k861082-cordis-cath-sheath-introducmid-length-fda-510k.jpg K861082 - CORDIS CATH SHEATH INTRODUC/MID-LENGTH SHEATH SYST K861082 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared May 1986. https://www.510kdatabase.net/k861155/ 1986-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k861155-emit-desipramine-assay-fda-510k.jpg K861155 - EMIT DESIPRAMINE ASSAY K861155 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared May 1986. https://www.510kdatabase.net/k854618/ 1986-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k854618-cordot-r-fda-510k.jpg K854618 - CORDOT R K854618 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Cordis Corp.. Cleared May 1986. https://www.510kdatabase.net/k861010/ 1986-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k861010-vma-by-hplc-test-vanilmandelic-acid-fda-510k.jpg K861010 - VMA BY HPLC TEST (VANILMANDELIC ACID) K861010 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared May 1986. https://www.510kdatabase.net/k861329/ 1986-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k861329-isotrak-amylase-isoenzyme-control-set-fda-510k.jpg K861329 - ISOTRAK AMYLASE ISOENZYME CONTROL SET K861329 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Apr 1986. https://www.510kdatabase.net/k855201/ 1986-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k855201-bard-parker-perfusion-catheter-fda-510k.jpg K855201 - BARD PARKER PERFUSION CATHETER K855201 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1986. https://www.510kdatabase.net/k860362/ 1986-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k860362-silicath-ag-silicone-elastomer-foley-fda-510k.jpg K860362 - SILICATH-AG SILICONE ELASTOMER FOLEY CATHETER K860362 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Apr 1986. https://www.510kdatabase.net/k861176/ 1986-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k861176-model-366-20-adaptaid-step-down-adapter-fda-510k.jpg K861176 - MODEL 366-20 ADAPTAID STEP-DOWN ADAPTER K861176 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Apr 1986. https://www.510kdatabase.net/k854370/ 1986-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k854370-mpv-7201-non-invasive-blood-pressure-fda-510k.jpg K854370 - MPV-7201 NON-INVASIVE BLOOD PRESSURE MONITOR K854370 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Apr 1986. https://www.510kdatabase.net/k860335/ 1986-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k860335-coat-a-count-17-alpha-fda-510k.jpg K860335 - COAT-A-COUNT 17-ALPHA-HYDROXYPROGESTERONE RIA KIT K860335 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Apr 1986. https://www.510kdatabase.net/k861055/ 1986-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k861055-easy-test-ise-calibrator-item-no-6756695-fda-510k.jpg K861055 - EASY-TEST ISE CALIBRATOR, ITEM NO. 67566/95 K861055 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Apr 1986. https://www.510kdatabase.net/k861061/ 1986-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k861061-emds-creatine-kinase-isoenzyme-ckmb-fda-510k.jpg K861061 - EMDS CREATINE KINASE ISOENZYME CKMB TEST PACK K861061 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Apr 1986. https://www.510kdatabase.net/k861221/ 1986-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k861221-easy-test-chek-instrum-check-emds-abs-fda-510k.jpg K861221 - EASY-TEST CHEK (INSTRUM. CHECK) & EMDS ABS TEST K861221 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Apr 1986. https://www.510kdatabase.net/k861110/ 1986-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k861110-model-366-10-adaptaid-step-down-adapter-fda-510k.jpg K861110 - MODEL 366-10 ADAPTAID STEP-DOWN ADAPTER K861110 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Apr 1986. https://www.510kdatabase.net/k861174/ 1986-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k861174-shiley-silicone-dual-lumen-subclavian-fda-510k.jpg K861174 - SHILEY SILICONE DUAL LUMEN SUBCLAVIAN CANNULA K861174 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Shiley, Inc.. Cleared Apr 1986. https://www.510kdatabase.net/k853889/ 1986-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k853889-cordia-cmv-m-fda-510k.jpg K853889 - CORDIA CMV-M K853889 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Cordis Corp.. Cleared Apr 1986. https://www.510kdatabase.net/k861002/ 1986-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k861002-vision-sgpt-alt-fda-510k.jpg K861002 - VISION SGPT (ALT) K861002 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1986. https://www.510kdatabase.net/k860162/ 1986-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k860162-flo-gard-6200-volumetric-infusion-pump-fda-510k.jpg K860162 - FLO-GARD 6200 VOLUMETRIC INFUSION PUMP K860162 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Apr 1986. https://www.510kdatabase.net/k860212/ 1986-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k860212-cardiofax-ecg-6353-fda-510k.jpg K860212 - CARDIOFAX ECG-6353 K860212 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Apr 1986. https://www.510kdatabase.net/k860647/ 1986-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k860647-es600-immunoassay-system-fda-510k.jpg K860647 - ES600 IMMUNOASSAY SYSTEM K860647 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Apr 1986. https://www.510kdatabase.net/k860748/ 1986-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k860748-hitachi-736-fda-510k.jpg K860748 - HITACHI 736 K860748 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Apr 1986. https://www.510kdatabase.net/k860833/ 1986-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k860833-epidural-anesthesia-tray-fda-510k.jpg K860833 - EPIDURAL ANESTHESIA TRAY K860833 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Apr 1986. https://www.510kdatabase.net/k861114/ 1986-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k861114-malloryhead-pf-acetabular-component-fda-510k.jpg K861114 - MALLORY/HEAD - PF ACETABULAR COMPONENT K861114 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Apr 1986. https://www.510kdatabase.net/k860894/ 1986-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k860894-behring-nephelometer-system-fda-510k.jpg K860894 - BEHRING NEPHELOMETER SYSTEM K860894 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Apr 1986. https://www.510kdatabase.net/k861178/ 1986-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k861178-depuy-compression-hip-screw-system-fda-510k.jpg K861178 - DEPUY COMPRESSION HIP SCREW SYSTEM K861178 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Apr 1986. https://www.510kdatabase.net/k854996/ 1986-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k854996-ultrasonic-couplant-gel-fda-510k.jpg K854996 - ULTRASONIC COUPLANT GEL K854996 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Apr 1986. https://www.510kdatabase.net/k860747/ 1986-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k860747-du-pont-sorvall-centrifuges-rapidspin-r-fda-510k.jpg K860747 - DU PONT SORVALL CENTRIFUGES (RAPIDSPIN R) K860747 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Apr 1986. https://www.510kdatabase.net/k861086/ 1986-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k861086-zimmer-vacuum-mixing-system-fda-510k.jpg K861086 - ZIMMER VACUUM MIXING SYSTEM K861086 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Apr 1986. https://www.510kdatabase.net/k861105/ 1986-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k861105-howmedica-bipolar-prosthesis-fda-510k.jpg K861105 - HOWMEDICA BIPOLAR PROSTHESIS K861105 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Apr 1986. https://www.510kdatabase.net/k854525/ 1986-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k854525-fox-fastidious-test-panel-fda-510k.jpg K854525 - FOX FASTIDIOUS TEST PANEL K854525 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Apr 1986. https://www.510kdatabase.net/k860032/ 1986-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k860032-total-ige-irma-ria-kit-fda-510k.jpg K860032 - TOTAL IGE-IRMA RIA KIT K860032 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Apr 1986. https://www.510kdatabase.net/k860288/ 1986-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k860288-echoclonal-htsh-irma-fda-510k.jpg K860288 - ECHOCLONAL HTSH IRMA K860288 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Apr 1986. https://www.510kdatabase.net/k860422/ 1986-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k860422-strat-thyroid-uptake-fluromet-enzyme-fda-510k.jpg K860422 - STRAT THYROID UPTAKE FLUROMET ENZYME IMMUNOASSAY K860422 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Apr 1986. https://www.510kdatabase.net/k860500/ 1986-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k860500-emit-dau-cannabinoid-20ng-assay-fda-510k.jpg K860500 - EMIT D.A.U. CANNABINOID 20NG ASSAY K860500 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Apr 1986. https://www.510kdatabase.net/k860525/ 1986-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k860525-abuscreen-radioimmunoassay-for-lsd-w-fda-510k.jpg K860525 - ABUSCREEN RADIOIMMUNOASSAY FOR LSD W/ REF STANDARD K860525 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Apr 1986. https://www.510kdatabase.net/k861253/ 1986-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k861253-tissue-culture-flask-pl-732-plastic-fda-510k.jpg K861253 - TISSUE CULTURE FLASK PL 732 PLASTIC K861253 is a FDA 510(k) cleared pathology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Apr 1986. https://www.510kdatabase.net/k861259/ 1986-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k861259-macconkey-wmug-fda-510k.jpg K861259 - MACCONKEY W/MUG K861259 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Apr 1986. https://www.510kdatabase.net/k861024/ 1986-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k861024-bard-absorption-dressing-fda-510k.jpg K861024 - BARD ABSORPTION DRESSING K861024 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 1986. https://www.510kdatabase.net/k853663/ 1986-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k853663-accessus-cryopreservation-pkg-sterile-fda-510k.jpg K853663 - ACCESSUS CRYOPRESERVATION PKG. STERILE TISSUE STOR K853663 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Apr 1986. https://www.510kdatabase.net/k854866/ 1986-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k854866-long-term-recorder-rag-1200-fda-510k.jpg K854866 - LONG TERM RECORDER RAG 1200 K854866 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Apr 1986. https://www.510kdatabase.net/k860042/ 1986-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k860042-nutrimix-empty-container-fda-510k.jpg K860042 - NUTRIMIX EMPTY CONTAINER K860042 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1986. https://www.510kdatabase.net/k860229/ 1986-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k860229-model-900-infusion-pump-fda-510k.jpg K860229 - MODEL 900 INFUSION PUMP K860229 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 1986. https://www.510kdatabase.net/k860640/ 1986-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k860640-easy-test-ggt-reagent-item-no-6752693-fda-510k.jpg K860640 - EASY-TEST (GGT) REAGENT, ITEM NO. 67526/93 K860640 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Apr 1986. https://www.510kdatabase.net/k860620/ 1986-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k860620-shampaine-radi-op-model-1700rc-fda-510k.jpg K860620 - SHAMPAINE RADI-OP MODEL 1700RC K860620 is a FDA 510(k) cleared radiology medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Apr 1986. https://www.510kdatabase.net/k851338/ 1986-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k851338-double-antibody-albumin-for-detect-fda-510k.jpg K851338 - DOUBLE ANTIBODY ALBUMIN FOR DETECT MICROALBUMINURI K851338 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Apr 1986. https://www.510kdatabase.net/k854308/ 1986-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k854308-polycath-h-catheter-fda-510k.jpg K854308 - POLYCATH-H CATHETER K854308 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1986. https://www.510kdatabase.net/k855002/ 1986-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k855002-kodak-ektascan-image-transmission-system-fda-510k.jpg K855002 - KODAK EKTASCAN IMAGE TRANSMISSION SYSTEM K855002 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Apr 1986. https://www.510kdatabase.net/k860033/ 1986-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k860033-eia-monoclonal-total-ige-kit-fda-510k.jpg K860033 - EIA MONOCLONAL TOTAL IGE KIT K860033 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Apr 1986. https://www.510kdatabase.net/k860668/ 1986-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k860668-ion-specific-electrode-chloride-fda-510k.jpg K860668 - ION-SPECIFIC ELECTRODE, CHLORIDE K860668 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Apr 1986. https://www.510kdatabase.net/k860669/ 1986-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k860669-creatine-kinase-n-acetyl-l-cystiene-fda-510k.jpg K860669 - CREATINE KINASE, N-ACETYL-L-CYSTIENE K860669 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Apr 1986. https://www.510kdatabase.net/k860700/ 1986-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k860700-capd-disconnect-system-5c4182-5c4183-fda-510k.jpg K860700 - CAPD DISCONNECT SYSTEM 5C4182, 5C4183, 5C4186 K860700 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Apr 1986. https://www.510kdatabase.net/k860746/ 1986-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k860746-auto-syringe-micro-vol-ext-set-wair-fda-510k.jpg K860746 - AUTO SYRINGE MICRO VOL EXT SET W/AIR VENT FILTER K860746 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Apr 1986. https://www.510kdatabase.net/k860764/ 1986-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k860764-emds-enzyme-verifier-levels-i-ii-fda-510k.jpg K860764 - EMDS ENZYME VERIFIER, LEVELS I & II K860764 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Apr 1986. https://www.510kdatabase.net/k860765/ 1986-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k860765-emds-chemistry-calibrators-levels-i-ii-fda-510k.jpg K860765 - EMDS CHEMISTRY CALIBRATORS, LEVELS I & II K860765 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Apr 1986. https://www.510kdatabase.net/k860916/ 1986-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k860916-easy-test-uric-acid-uric-6751693-fda-510k.jpg K860916 - EASY-TEST URIC ACID (URIC), #67516/93 K860916 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Apr 1986. https://www.510kdatabase.net/k860917/ 1986-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k860917-easy-test-total-protein-tp-6751393-fda-510k.jpg K860917 - EASY-TEST TOTAL PROTEIN (TP), #67513/93 K860917 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Apr 1986. https://www.510kdatabase.net/k861225/ 1986-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k861225-kodak-automixer-ii-fda-510k.jpg K861225 - KODAK AUTOMIXER II K861225 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Apr 1986. https://www.510kdatabase.net/k860424/ 1986-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k860424-a-gent-liquid-total-bilirubin-fda-510k.jpg K860424 - A-GENT LIQUID TOTAL BILIRUBIN K860424 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1986. https://www.510kdatabase.net/k860425/ 1986-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k860425-a-gent-liquid-calcium-fda-510k.jpg K860425 - A-GENT LIQUID CALCIUM K860425 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1986. https://www.510kdatabase.net/k860426/ 1986-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k860426-a-gent-liquid-total-protein-fda-510k.jpg K860426 - A-GENT LIQUID TOTAL PROTEIN K860426 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1986. https://www.510kdatabase.net/k860641/ 1986-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k860641-easy-test-che-reagent-item-no-6752293-fda-510k.jpg K860641 - EASY-TEST (CHE) REAGENT, ITEM NO. 67522/93 K860641 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Apr 1986. https://www.510kdatabase.net/k860799/ 1986-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k860799-analyte-irontechnicon-chem-1-system-fda-510k.jpg K860799 - ANALYTE IRON/TECHNICON CHEM 1 SYSTEM K860799 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Apr 1986. https://www.510kdatabase.net/k860868/ 1986-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k860868-technicon-ra-systemstobramycin-fda-510k.jpg K860868 - TECHNICON RA SYSTEMS/TOBRAMYCIN & GENTAMICIN K860868 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Apr 1986. https://www.510kdatabase.net/k860918/ 1986-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k860918-easy-test-amlase-amyl-6752193-fda-510k.jpg K860918 - EASY-TEST AMLASE (AMYL), #67521/93 K860918 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Apr 1986. https://www.510kdatabase.net/k860970/ 1986-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k860970-precinorm-im-and-precipath-im-fda-510k.jpg K860970 - PRECINORM IM AND PRECIPATH IM K860970 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Apr 1986. https://www.510kdatabase.net/k861050/ 1986-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k861050-biopsy-adapter-h4222w-fda-510k.jpg K861050 - BIOPSY ADAPTER H4222W K861050 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: General Electric Co.. Cleared Apr 1986. https://www.510kdatabase.net/k855200/ 1986-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k855200-modular-press-fit-mpf-stem-fda-510k.jpg K855200 - MODULAR PRESS FIT (MPF) STEM K855200 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Apr 1986. https://www.510kdatabase.net/k860913/ 1986-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k860913-siregraph-d-fda-510k.jpg K860913 - SIREGRAPH D K860913 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 1986. https://www.510kdatabase.net/k853669/ 1986-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k853669-model-43400a-real-time-ambulatory-ecg-fda-510k.jpg K853669 - MODEL 43400A REAL-TIME AMBULATORY ECG MONITOR ANAL K853669 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Mar 1986. https://www.510kdatabase.net/k854319/ 1986-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k854319-schneider-shiley-peripheral-dilatation-fda-510k.jpg K854319 - SCHNEIDER-SHILEY PERIPHERAL DILATATION CATHETER K854319 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Mar 1986. https://www.510kdatabase.net/k860832/ 1986-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k860832-model-366-08-adaptaid-connector-adapter-fda-510k.jpg K860832 - MODEL 366-08 ADAPTAID CONNECTOR ADAPTER K860832 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Mar 1986. https://www.510kdatabase.net/k860985/ 1986-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k860985-model-366-19-adaptaid-adapter-sleeve-fda-510k.jpg K860985 - MODEL 366-19 ADAPTAID ADAPTER SLEEVE K860985 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Mar 1986. https://www.510kdatabase.net/k860986/ 1986-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k860986-model-366-09-adaptaid-adapter-sleeve-fda-510k.jpg K860986 - MODEL 366-09 ADAPTAID ADAPTER SLEEVE K860986 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Mar 1986. https://www.510kdatabase.net/k860137/ 1986-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k860137-enzymun-test-ferritin-fda-510k.jpg K860137 - ENZYMUN-TEST FERRITIN K860137 is a FDA 510(k) cleared immunology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Mar 1986. https://www.510kdatabase.net/k860138/ 1986-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k860138-no-615-determination-of-ceruloplasmin-fda-510k.jpg K860138 - NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUM K860138 is a FDA 510(k) cleared immunology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Mar 1986. https://www.510kdatabase.net/k860629/ 1986-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k860629-biogram-apo-a1b-fda-510k.jpg K860629 - BIOGRAM APO A1/B K860629 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Mar 1986. https://www.510kdatabase.net/k860756/ 1986-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k860756-grosse-and-kempf-locking-nail-system-fda-510k.jpg K860756 - GROSSE AND KEMPF LOCKING NAIL SYSTEM, NON-SLOT ROD K860756 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Mar 1986. https://www.510kdatabase.net/k860904/ 1986-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k860904-video-printer-model-3200-fda-510k.jpg K860904 - VIDEO PRINTER, MODEL 3200 K860904 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medline Industries, Inc.. Cleared Mar 1986. https://www.510kdatabase.net/k860486/ 1986-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k860486-actisorb-activated-charcoal-dressing-fda-510k.jpg K860486 - ACTISORB ACTIVATED CHARCOAL DRESSING K860486 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Mar 1986. https://www.510kdatabase.net/k860569/ 1986-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k860569-endodontic-root-canal-plugger-fda-510k.jpg K860569 - ENDODONTIC ROOT CANAL PLUGGER K860569 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Mar 1986. https://www.510kdatabase.net/k860608/ 1986-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k860608-artificial-teeth-porcelain-modified-fda-510k.jpg K860608 - ARTIFICIAL TEETH, PORCELAIN, MODIFIED K860608 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Mar 1986. https://www.510kdatabase.net/k860541/ 1986-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k860541-solution-administration-set-fda-510k.jpg K860541 - SOLUTION ADMINISTRATION SET K860541 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Mar 1986. https://www.510kdatabase.net/k854667/ 1986-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k854667-75-mhz-linear-array-sonoline-probe-fda-510k.jpg K854667 - 7.5 MHZ LINEAR ARRAY SONOLINE PROBE K854667 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 1986. https://www.510kdatabase.net/k854668/ 1986-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k854668-50-mhz-linear-array-sonoline-probe-fda-510k.jpg K854668 - 5.0 MHZ LINEAR ARRAY SONOLINE PROBE K854668 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 1986. https://www.510kdatabase.net/k853805/ 1986-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k853805-micro-media-microdilution-test-panels-fda-510k.jpg K853805 - MICRO-MEDIA MICRODILUTION TEST PANELS K853805 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Mar 1986. https://www.510kdatabase.net/k860701/ 1986-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k860701-hps-ii-smooth-stem-fda-510k.jpg K860701 - HPS II SMOOTH STEM K860701 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Mar 1986. https://www.510kdatabase.net/k860272/ 1986-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k860272-solution-administration-sets-fda-510k.jpg K860272 - SOLUTION ADMINISTRATION SETS K860272 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Mar 1986. https://www.510kdatabase.net/k854725/ 1986-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k854725-hurwitz-amniocentesis-needle-fda-510k.jpg K854725 - HURWITZ AMNIOCENTESIS NEEDLE K854725 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1986. https://www.510kdatabase.net/k855147/ 1986-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k855147-medtronic-models-831683178318-pulse-fda-510k.jpg K855147 - MEDTRONIC MODELS 8316,8317,8318 PULSE GENERATORS K855147 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Mar 1986. https://www.510kdatabase.net/k860054/ 1986-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k860054-tsh-irma-coat-a-count-kit-fda-510k.jpg K860054 - TSH-IRMA COAT-A-COUNT KIT K860054 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Mar 1986. https://www.510kdatabase.net/k860146/ 1986-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k860146-polyjel-nf-new-formula-fda-510k.jpg K860146 - POLYJEL N.F. (NEW FORMULA) K860146 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Mar 1986. https://www.510kdatabase.net/k860313/ 1986-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k860313-30-mhz-linear-array-probe-model-ust-5031-fda-510k.jpg K860313 - 3.0 MHZ LINEAR ARRAY PROBE MODEL UST 5031 K860313 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Mar 1986. https://www.510kdatabase.net/k860355/ 1986-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k860355-bovine-chemistry-control-ix-and-iix-fda-510k.jpg K860355 - BOVINE CHEMISTRY CONTROL I.X AND II.X K860355 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Mar 1986. https://www.510kdatabase.net/k860423/ 1986-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k860423-a-gent-liquid-albumin-fda-510k.jpg K860423 - A-GENT LIQUID ALBUMIN K860423 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1986. https://www.510kdatabase.net/k860437/ 1986-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k860437-partial-denture-alloy-fda-510k.jpg K860437 - PARTIAL DENTURE ALLOY K860437 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Mar 1986. https://www.510kdatabase.net/k851243/ 1986-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k851243-greco-harvey-surfact-bond-cath-fda-510k.jpg K851243 - GRECO-HARVEY SURFACT BOND CATH HYPERALIMENTATION K851243 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cook, Inc.. Cleared Mar 1986. https://www.510kdatabase.net/k860594/ 1986-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k860594-synatomic-revision-femoral-prosthesis-fda-510k.jpg K860594 - SYNATOMIC REVISION FEMORAL PROSTHESIS K860594 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Mar 1986. https://www.510kdatabase.net/k860654/ 1986-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k860654-mcr-knee-prosthesis-series-3000-fda-510k.jpg K860654 - M.C.R. KNEE PROSTHESIS (SERIES 3000) K860654 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Mar 1986. https://www.510kdatabase.net/k854168/ 1986-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k854168-travenol-disposable-dental-fda-510k.jpg K854168 - TRAVENOL DISPOSABLE DENTAL SCALERS/CURETTES K854168 is a FDA 510(k) cleared dental medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Mar 1986. https://www.510kdatabase.net/k860600/ 1986-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k860600-singlemultiple-component-metallic-bone-fda-510k.jpg K860600 - SINGLE/MULTIPLE COMPONENT METALLIC BONE FIXATION K860600 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 3M Company. Cleared Mar 1986. https://www.510kdatabase.net/k860691/ 1986-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k860691-kodak-ektascan-video-camera-compact-fda-510k.jpg K860691 - KODAK EKTASCAN VIDEO CAMERA & COMPACT VIDEO CAMERA K860691 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Mar 1986. https://www.510kdatabase.net/k860845/ 1986-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k860845-respironics-secureasy-fda-510k.jpg K860845 - RESPIRONICS SECUREASY K860845 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Mar 1986. https://www.510kdatabase.net/k854881/ 1986-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k854881-sirecust-341-and-341r-fda-510k.jpg K854881 - SIRECUST 341 AND 341R K854881 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 1986. https://www.510kdatabase.net/k854917/ 1986-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k854917-model-435-01-cardifix-implantable-fda-510k.jpg K854917 - MODEL 435-01 CARDIFIX IMPLANTABLE PACING LEAD K854917 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Mar 1986. https://www.510kdatabase.net/k854918/ 1986-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k854918-model-431-01-biopore-implantable-fda-510k.jpg K854918 - MODEL 431-01 BIOPORE IMPLANTABLE PACING LEAD K854918 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Mar 1986. https://www.510kdatabase.net/k860707/ 1986-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k860707-ofpbl-fda-510k.jpg K860707 - OFPBL K860707 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Mar 1986. https://www.510kdatabase.net/k852686/ 1986-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k852686-sonoline-cd-fda-510k.jpg K852686 - SONOLINE CD K852686 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 1986. https://www.510kdatabase.net/k852739/ 1986-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k852739-sonoline-sx-ultrasound-scanner-fda-510k.jpg K852739 - SONOLINE SX ULTRASOUND SCANNER K852739 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 1986. https://www.510kdatabase.net/k860133/ 1986-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k860133-modified-synatomic-variable-fit-tibial-fda-510k.jpg K860133 - MODIFIED SYNATOMIC VARIABLE FIT TIBIAL PLATEAU K860133 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Mar 1986. https://www.510kdatabase.net/k855106/ 1986-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k855106-imipenem-10-mcg-sensi-disccat-3164431645-fda-510k.jpg K855106 - IMIPENEM 10 MCG SENSI-DISC,CAT. # 31644/31645 K855106 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1986. https://www.510kdatabase.net/k860129/ 1986-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k860129-iso-mammo-fda-510k.jpg K860129 - ISO-MAMMO K860129 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Mar 1986. https://www.510kdatabase.net/k860666/ 1986-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k860666-kodak-x-omat-processor-model-me-3-fda-510k.jpg K860666 - KODAK X-OMAT PROCESSOR, MODEL ME-3 K860666 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Mar 1986. https://www.510kdatabase.net/k860754/ 1986-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k860754-kodak-t-mat-m-film-so-245-fda-510k.jpg K860754 - KODAK T-MAT M FILM SO-245 K860754 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Mar 1986. https://www.510kdatabase.net/k860755/ 1986-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k860755-kodak-min-r-fast-screen-so-459-fda-510k.jpg K860755 - KODAK MIN-R FAST SCREEN SO-459 K860755 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Mar 1986. https://www.510kdatabase.net/k855079/ 1986-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k855079-neonatal-bilirubinnbil-test-pack-6766195-fda-510k.jpg K855079 - NEONATAL BILIRUBIN(NBIL) TEST PACK 67661/95 K855079 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Mar 1986. https://www.510kdatabase.net/k853009/ 1986-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k853009-cobas-bact-id-test-sys-indole-spot-fda-510k.jpg K853009 - COBAS BACT ID TEST SYS, INDOLE SPOT TEST REAGENT K853009 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Mar 1986. https://www.510kdatabase.net/k855216/ 1986-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k855216-3m-arthroscopic-surgical-system-fda-510k.jpg K855216 - 3M ARTHROSCOPIC SURGICAL SYSTEM K855216 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 3M Company. Cleared Mar 1986. https://www.510kdatabase.net/k860515/ 1986-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k860515-dual-lumen-needle-product-change-fda-510k.jpg K860515 - DUAL LUMEN NEEDLE (PRODUCT CHANGE) K860515 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quinton, Inc.. Cleared Mar 1986. https://www.510kdatabase.net/k860536/ 1986-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k860536-cefotetan-30-mcg-sensi-disc-fda-510k.jpg K860536 - CEFOTETAN 30 MCG SENSI DISC K860536 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1986. https://www.510kdatabase.net/k854369/ 1986-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k854369-wep-7604-telemetry-monitor-fda-510k.jpg K854369 - WEP 7604 TELEMETRY MONITOR K854369 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Feb 1986. https://www.510kdatabase.net/k854372/ 1986-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k854372-vm-781-slave-scope-fda-510k.jpg K854372 - VM 781 SLAVE SCOPE K854372 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Feb 1986. https://www.510kdatabase.net/k854482/ 1986-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k854482-alternate-sterile-pkg-implantable-fda-510k.jpg K854482 - ALTERNATE STERILE PKG IMPLANTABLE PULSE GENERATORS K854482 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Feb 1986. https://www.510kdatabase.net/k854743/ 1986-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k854743-25-mhz-phased-array-sector-meridian-fda-510k.jpg K854743 - 2.5 MHZ PHASED ARRAY SECTOR MERIDIAN PROBE K854743 is a FDA 510(k) cleared radiology medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Feb 1986. https://www.510kdatabase.net/k860147/ 1986-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k860147-carbon-dioxide-absorbents-fda-510k.jpg K860147 - CARBON DIOXIDE ABSORBENTS K860147 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Dentsply Intl.. Cleared Feb 1986. https://www.510kdatabase.net/k860303/ 1986-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k860303-dupont-phenobarbital-calibrator-fda-510k.jpg K860303 - DUPONT PHENOBARBITAL CALIBRATOR K860303 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Feb 1986. https://www.510kdatabase.net/k860304/ 1986-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k860304-dupont-phenobarbital-assay-fda-510k.jpg K860304 - DUPONT PHENOBARBITAL ASSAY K860304 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Feb 1986. https://www.510kdatabase.net/k855231/ 1986-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k855231-howmedica-bipolar-prosthesis-fda-510k.jpg K855231 - HOWMEDICA BIPOLAR PROSTHESIS K855231 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Feb 1986. https://www.510kdatabase.net/k860115/ 1986-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k860115-digilab-cambridge-perimeter-fda-510k.jpg K860115 - DIGILAB CAMBRIDGE PERIMETER K860115 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Bio-Rad. Cleared Feb 1986. https://www.510kdatabase.net/k851241/ 1986-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k851241-greco-harvey-surfactant-bonded-fda-510k.jpg K851241 - GRECO-HARVEY SURFACTANT BONDED CATHETER FOR CARDIO K851241 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Feb 1986. https://www.510kdatabase.net/k854576/ 1986-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k854576-modified-cordis-ptca-guiding-catheters-fda-510k.jpg K854576 - MODIFIED CORDIS PTCA GUIDING CATHETERS K854576 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Feb 1986. https://www.510kdatabase.net/k855057/ 1986-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k855057-laser-crp-kitc-reactive-protein-reagents-fda-510k.jpg K855057 - LASER CRP KIT(C-REACTIVE PROTEIN REAGENTS) K855057 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Feb 1986. https://www.510kdatabase.net/k855126/ 1986-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k855126-cordis-catheter-sheath-fda-510k.jpg K855126 - CORDIS CATHETER SHEATH INTRODUCERS,STERI-SLEEVES K855126 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Feb 1986. https://www.510kdatabase.net/k860183/ 1986-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k860183-aft-hep-system-fda-510k.jpg K860183 - AFT-HEP SYSTEM K860183 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Feb 1986. https://www.510kdatabase.net/k853240/ 1986-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k853240-meridian-ultrasound-imaging-system-fda-510k.jpg K853240 - MERIDIAN ULTRASOUND IMAGING SYSTEM K853240 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Feb 1986. https://www.510kdatabase.net/k854416/ 1986-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k854416-tdx-transferrin-diagnostic-kit-fda-510k.jpg K854416 - TDX TRANSFERRIN DIAGNOSTIC KIT K854416 is a FDA 510(k) cleared immunology medical device. Manufacturer: Abbott Laboratories. Cleared Feb 1986. https://www.510kdatabase.net/k860135/ 1986-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k860135-easy-test-urea-bun-reagent-fda-510k.jpg K860135 - EASY-TEST UREA (BUN) REAGENT K860135 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Feb 1986. https://www.510kdatabase.net/k855199/ 1986-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k855199-paramax-comprehensive-calibrator-fda-510k.jpg K855199 - PARAMAX COMPREHENSIVE CALIBRATOR K855199 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Feb 1986. https://www.510kdatabase.net/k860453/ 1986-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k860453-ace-controls-normal-elevated-no-a6040-fda-510k.jpg K860453 - ACE CONTROLS, NORMAL & ELEVATED, NO. A6040 & A7040 K860453 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Feb 1986. https://www.510kdatabase.net/k855148/ 1986-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k855148-tharies-fiber-fda-510k.jpg K855148 - THARIES FIBER K855148 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Feb 1986. https://www.510kdatabase.net/k853702/ 1986-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k853702-ultrasound-couplant-sheetsolid-fda-510k.jpg K853702 - ULTRASOUND COUPLANT SHEET/SOLID ULTRASOUND COUPLAN K853702 is a FDA 510(k) cleared radiology medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Feb 1986. https://www.510kdatabase.net/k854670/ 1986-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k854670-terumo-sensibead-eig-hcg-kit-fda-510k.jpg K854670 - TERUMO SENSIBEAD EIG HCG KIT K854670 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Terumo Medical Corp.. Cleared Feb 1986. https://www.510kdatabase.net/k852137/ 1986-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k852137-fenlin-total-shoulder-fda-510k.jpg K852137 - FENLIN TOTAL SHOULDER K852137 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Feb 1986. https://www.510kdatabase.net/k853250/ 1986-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k853250-femorotibial-medullary-nail-fda-510k.jpg K853250 - FEMOROTIBIAL MEDULLARY NAIL K853250 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Feb 1986. https://www.510kdatabase.net/k854863/ 1986-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k854863-flo-gard-4000-volumetric-infusion-fda-510k.jpg K854863 - FLO-GARD 4000 VOLUMETRIC INFUSION CONTROLLER K854863 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Feb 1986. https://www.510kdatabase.net/k854987/ 1986-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k854987-intra-articulated-arthroscopic-power-fda-510k.jpg K854987 - INTRA-ARTICULATED ARTHROSCOPIC POWER SYSTEM K854987 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Feb 1986. https://www.510kdatabase.net/k855080/ 1986-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k855080-emds-glucose-test-pack-item-6765695-fda-510k.jpg K855080 - EMDS GLUCOSE TEST PACK ITEM 67656/95 K855080 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Feb 1986. https://www.510kdatabase.net/k855203/ 1986-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k855203-glucolet-automatic-lancing-device-for-fda-510k.jpg K855203 - GLUCOLET AUTOMATIC LANCING DEVICE FOR OBT. BLOOD K855203 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Feb 1986. https://www.510kdatabase.net/k860021/ 1986-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k860021-dimensiontm-clinical-chemistry-system-fda-510k.jpg K860021 - DIMENSION(TM) CLINICAL CHEMISTRY SYSTEM K860021 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Feb 1986. https://www.510kdatabase.net/k860097/ 1986-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k860097-therapeutic-drug-tdm-calibrator-fda-510k.jpg K860097 - THERAPEUTIC DRUG (TDM) CALIBRATOR K860097 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Feb 1986. https://www.510kdatabase.net/k860141/ 1986-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k860141-stratus-procainamide-fluorometric-fda-510k.jpg K860141 - STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNO. K860141 is a FDA 510(k) cleared toxicology medical device. Manufacturer: American Dade. Cleared Feb 1986. https://www.510kdatabase.net/k860421/ 1986-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k860421-strat-total-thyroxine-fluoromet-enzyme-fda-510k.jpg K860421 - STRAT TOTAL THYROXINE FLUOROMET ENZYME IMMUNOASSAY K860421 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Feb 1986. https://www.510kdatabase.net/k854640/ 1986-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k854640-modified-coronary-cardioplegia-adaptor-fda-510k.jpg K854640 - MODIFIED CORONARY CARDIOPLEGIA ADAPTOR K854640 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Feb 1986. https://www.510kdatabase.net/k854841/ 1986-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k854841-shiley-venous-reservoir-fda-510k.jpg K854841 - SHILEY VENOUS RESERVOIR K854841 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Feb 1986. https://www.510kdatabase.net/k855003/ 1986-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k855003-beraha-biopsy-needles-2n2730-2n2731-fda-510k.jpg K855003 - BERAHA BIOPSY NEEDLES, 2N2730, 2N2731 & 2N2732 K855003 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Feb 1986. https://www.510kdatabase.net/k853626/ 1986-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k853626-codman-laser-backstop-fda-510k.jpg K853626 - CODMAN LASER BACKSTOP K853626 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Feb 1986. https://www.510kdatabase.net/k853627/ 1986-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k853627-codman-laser-rods-fda-510k.jpg K853627 - CODMAN LASER RODS K853627 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Feb 1986. https://www.510kdatabase.net/k854936/ 1986-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k854936-eia-processor-fda-510k.jpg K854936 - EIA PROCESSOR K854936 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Feb 1986. https://www.510kdatabase.net/k860029/ 1986-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k860029-ldh-optimized-reagent-fda-510k.jpg K860029 - LDH (OPTIMIZED) REAGENT K860029 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Feb 1986. https://www.510kdatabase.net/k860134/ 1986-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k860134-easy-test-alkaline-phosphatase-alp-fda-510k.jpg K860134 - EASY-TEST ALKALINE PHOSPHATASE (ALP) REAGENT K860134 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Feb 1986. https://www.510kdatabase.net/k860140/ 1986-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k860140-stratus-n-ace-napa-fluorometric-fda-510k.jpg K860140 - STRATUS N-ACE (NAPA) FLUOROMETRIC ENZYME/IMMUNO. K860140 is a FDA 510(k) cleared toxicology medical device. Manufacturer: American Dade. Cleared Feb 1986. https://www.510kdatabase.net/k853027/ 1986-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k853027-technicon-h1-system-mpxi-fda-510k.jpg K853027 - TECHNICON H*1 SYSTEM (MPXI) K853027 is a FDA 510(k) cleared hematology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Feb 1986. https://www.510kdatabase.net/k853030/ 1986-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k853030-technicon-h1-system-hdw-fda-510k.jpg K853030 - TECHNICON H*1 SYSTEM (HDW) K853030 is a FDA 510(k) cleared hematology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Feb 1986. https://www.510kdatabase.net/k860230/ 1986-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k860230-capd-transfer-set-spike-5c4363-fda-510k.jpg K860230 - CAPD TRANSFER SET SPIKE 5C4363 K860230 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Feb 1986. https://www.510kdatabase.net/k854361/ 1986-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k854361-co2-laser-laparoscope-system-fda-510k.jpg K854361 - CO2 LASER LAPAROSCOPE SYSTEM K854361 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Feb 1986. https://www.510kdatabase.net/k854547/ 1986-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k854547-monoject-sterile-m200-aluminumm250-fda-510k.jpg K854547 - MONOJECT STERILE M200 ALUMINUM/M250 POLYPROPYLENE K854547 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Feb 1986. https://www.510kdatabase.net/k854548/ 1986-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k854548-monoject-sterile-m216-blood-collection-fda-510k.jpg K854548 - MONOJECT STERILE M216 BLOOD COLLECTION NEEDLES K854548 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Feb 1986. https://www.510kdatabase.net/k854549/ 1986-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k854549-monoject-sterile-m400-plasticsterile-fda-510k.jpg K854549 - MONOJECT STERILE M400 PLASTIC&STERILE M401 ALUMINU K854549 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Feb 1986. https://www.510kdatabase.net/k852648/ 1986-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k852648-starport-model-h3300aa-fda-510k.jpg K852648 - STARPORT MODEL H3300AA K852648 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jan 1986. https://www.510kdatabase.net/k855063/ 1986-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k855063-universal-patient-chair-uni-2000x-fda-510k.jpg K855063 - UNIVERSAL PATIENT CHAIR UNI 2000X K855063 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 1986. https://www.510kdatabase.net/k854328/ 1986-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k854328-medex-x-ray-table-fda-510k.jpg K854328 - MEDEX X-RAY TABLE K854328 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Jan 1986. https://www.510kdatabase.net/k853629/ 1986-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k853629-bard-harvard-chronofusor-time-dose-fda-510k.jpg K853629 - BARD HARVARD CHRONOFUSOR TIME-DOSE SYRINGE INFUSIO K853629 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 1986. https://www.510kdatabase.net/k853029/ 1986-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k853029-technicon-h1-system-lobularity-indxlft-fda-510k.jpg K853029 - TECHNICON H*1 SYSTEM LOBULARITY INDX/LFT SHIFT FLA K853029 is a FDA 510(k) cleared hematology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Jan 1986. https://www.510kdatabase.net/k854542/ 1986-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k854542-tdx-c-reactive-protein-fda-510k.jpg K854542 - TDX C-REACTIVE PROTEIN K854542 is a FDA 510(k) cleared immunology medical device. Manufacturer: Abbott Laboratories. Cleared Jan 1986. https://www.510kdatabase.net/k854811/ 1986-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k854811-ics-pab-prealbumin-reagent-test-kit-fda-510k.jpg K854811 - ICS PAB PREALBUMIN REAGENT TEST KIT K854811 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jan 1986. https://www.510kdatabase.net/k855020/ 1986-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k855020-medical-dynamics-ccd-solid-state-video-fda-510k.jpg K855020 - MEDICAL DYNAMICS CCD SOLID STATE VIDEO CAMERA 5930 K855020 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medline Industries, Inc.. Cleared Jan 1986. https://www.510kdatabase.net/k860080/ 1986-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k860080-olympus-au-5000-chemistry-analyzer-fda-510k.jpg K860080 - OLYMPUS AU 5000 CHEMISTRY ANALYZER SYSTEM K860080 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Jan 1986. https://www.510kdatabase.net/k854566/ 1986-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k854566-terumo-surflo-etfe-iv-catheter-fda-510k.jpg K854566 - TERUMO SURFLO ETFE I.V. CATHETER K854566 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terumo Medical Corp.. Cleared Jan 1986. https://www.510kdatabase.net/k860075/ 1986-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k860075-dynafeed-enteral-pump-feed-bag-fda-510k.jpg K860075 - DYNAFEED ENTERAL PUMP FEED BAG K860075 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medline Industries, Inc.. Cleared Jan 1986. https://www.510kdatabase.net/k854245/ 1986-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k854245-sigma-angiotensin-converting-enzyme-fda-510k.jpg K854245 - SIGMA ANGIOTENSIN CONVERTING ENZYME 305-UV K854245 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Jan 1986. https://www.510kdatabase.net/k855040/ 1986-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k855040-seralyzer-total-bilirubin-calibrators-fda-510k.jpg K855040 - SERALYZER TOTAL BILIRUBIN CALIBRATORS K855040 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Jan 1986. https://www.510kdatabase.net/k855056/ 1986-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k855056-emds-total-ck-test-pack-6767095-fda-510k.jpg K855056 - EMDS TOTAL CK TEST PACK-#67670/95 K855056 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jan 1986. https://www.510kdatabase.net/k852988/ 1986-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k852988-technicon-h1-system-sub-classification-fda-510k.jpg K852988 - TECHNICON H*1 SYSTEM SUB-CLASSIFICATION LUC CAT. K852988 is a FDA 510(k) cleared hematology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Jan 1986. https://www.510kdatabase.net/k853585/ 1986-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k853585-olympus-evs-endoscopic-video-image-fda-510k.jpg K853585 - OLYMPUS EVS-ENDOSCOPIC VIDEO IMAGE & DATA SYS K853585 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Corp.. Cleared Jan 1986. https://www.510kdatabase.net/k854426/ 1986-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k854426-kodak-ektachem-hdl-cholesterol-kit-fda-510k.jpg K854426 - KODAK EKTACHEM HDL CHOLESTEROL KIT K854426 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Jan 1986. https://www.510kdatabase.net/k854766/ 1986-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k854766-creatinine-pap-fda-510k.jpg K854766 - CREATININE PAP K854766 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jan 1986. https://www.510kdatabase.net/k854946/ 1986-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k854946-tdxr-5-hiaa-urine-fda-510k.jpg K854946 - TDXR 5-HIAA (URINE) K854946 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jan 1986. https://www.510kdatabase.net/k855225/ 1986-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k855225-accu-chek-ii-low-and-high-glucose-fda-510k.jpg K855225 - ACCU-CHEK II LOW AND HIGH GLUCOSE CONTROL K855225 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jan 1986. https://www.510kdatabase.net/k853946/ 1986-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k853946-sonoline-lx-fda-510k.jpg K853946 - SONOLINE LX K853946 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 1986. https://www.510kdatabase.net/k851968/ 1986-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k851968-cordis-multicor-st-model-350a-fda-510k.jpg K851968 - CORDIS MULTICOR ST, MODEL 350A K851968 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Jan 1986. https://www.510kdatabase.net/k854982/ 1986-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k854982-vision-sgot-ast-fda-510k.jpg K854982 - VISION SGOT (AST) K854982 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jan 1986. https://www.510kdatabase.net/k855047/ 1986-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k855047-auto-suture-titanium-surgical-staples-fda-510k.jpg K855047 - AUTO SUTURE TITANIUM SURGICAL STAPLES K855047 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Jan 1986. https://www.510kdatabase.net/k853008/ 1986-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k853008-sonoline-sl-2ultrasound-scanner-fda-510k.jpg K853008 - SONOLINE SL-2(ULTRASOUND SCANNER) K853008 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 1986. https://www.510kdatabase.net/k854582/ 1986-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k854582-mod-targettips-401140124511451269124016-fda-510k.jpg K854582 - MOD TARGET/TIPS # 4011,4012,4511,4512,6912,4016 K854582 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jan 1986. https://www.510kdatabase.net/k854768/ 1986-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k854768-terumo-sensibead-eia-hprl-kit-fda-510k.jpg K854768 - TERUMO SENSIBEAD EIA HPRL KIT K854768 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Terumo Medical Corp.. Cleared Jan 1986. https://www.510kdatabase.net/k854846/ 1986-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k854846-vision-creatinine-fda-510k.jpg K854846 - VISION CREATININE K854846 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jan 1986. https://www.510kdatabase.net/k855135/ 1986-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k855135-cefaclor-sensi-disc-fda-510k.jpg K855135 - CEFACLOR SENSI-DISC K855135 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jan 1986. https://www.510kdatabase.net/k855043/ 1986-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k855043-3m-dry-silver-imager-fda-510k.jpg K855043 - 3M DRY SILVER IMAGER K855043 is a FDA 510(k) cleared radiology medical device. Manufacturer: 3M Company. Cleared Jan 1986. https://www.510kdatabase.net/k855058/ 1986-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k855058-evds-evmds-lds-ivmcs-central-nervous-fda-510k.jpg K855058 - EVDS, EVMDS, LDS & IVMCS CENTRAL NERVOUS SYS FLUID K855058 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cordis Corp.. Cleared Jan 1986. https://www.510kdatabase.net/k855213/ 1986-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k855213-pet-scope-ii-image-intensifier-fda-510k.jpg K855213 - PET-SCOPE II IMAGE INTENSIFIER K855213 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Jan 1986. https://www.510kdatabase.net/k855219/ 1986-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k855219-kodak-rp-x-omat-processor-model-m6b-fda-510k.jpg K855219 - KODAK RP X-OMAT PROCESSOR MODEL M6B K855219 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Jan 1986. https://www.510kdatabase.net/k854446/ 1986-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k854446-terumo-terufusion-blood-y-type-admin-set-fda-510k.jpg K854446 - TERUMO TERUFUSION BLOOD & Y-TYPE ADMIN. SET K854446 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terumo Medical Corp.. Cleared Jan 1986. https://www.510kdatabase.net/k851573/ 1986-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k851573-abbott-pharamacokinetics-systems-fda-510k.jpg K851573 - ABBOTT PHARAMACOKINETICS SYSTEMS K851573 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jan 1986. https://www.510kdatabase.net/k854523/ 1986-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k854523-analyst-physicians-office-profiler-fda-510k.jpg K854523 - ANALYST PHYSICIAN'S OFFICE PROFILER K854523 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Jan 1986. https://www.510kdatabase.net/k853951/ 1986-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k853951-isotrak-amylase-test-amylase-isoenzyme-fda-510k.jpg K853951 - ISOTRAK AMYLASE TEST AMYLASE ISOENZYME K853951 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Jan 1986. https://www.510kdatabase.net/k854986/ 1986-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k854986-bbl-port-a-cul-aerobic-transport-sys-fda-510k.jpg K854986 - BBL PORT-A-CUL AEROBIC TRANSPORT SYS, MODIFIED STU K854986 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jan 1986. https://www.510kdatabase.net/k854219/ 1986-01-01 monthly 0.5 https://www.510kdatabase.net/og-image/k854219-kodak-m35-x-omat-processor-fda-510k.jpg K854219 - KODAK M35 X-OMAT PROCESSOR K854219 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Jan 1986. https://www.510kdatabase.net/k854242/ 1986-01-01 monthly 0.5 https://www.510kdatabase.net/og-image/k854242-qbc-centrifugal-hematology-system-fda-510k.jpg K854242 - QBC CENTRIFUGAL HEMATOLOGY SYSTEM K854242 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jan 1986. https://www.510kdatabase.net/k854634/ 1985-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k854634-bard-parker-thoracic-vent-fda-510k.jpg K854634 - BARD PARKER THORACIC VENT K854634 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Dec 1985. https://www.510kdatabase.net/k854657/ 1985-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k854657-intracranial-pressure-monitoring-cup-fda-510k.jpg K854657 - INTRACRANIAL PRESSURE MONITORING CUP CATHETERS K854657 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cordis Corp.. Cleared Dec 1985. https://www.510kdatabase.net/k854559/ 1985-12-24 monthly 0.5 https://www.510kdatabase.net/og-image/k854559-medtronic-permanent-lead-introducer-fda-510k.jpg K854559 - MEDTRONIC PERMANENT LEAD INTRODUCER K854559 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Dec 1985. https://www.510kdatabase.net/k854135/ 1985-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k854135-hewlett-packard-ultrasound-transducer-fda-510k.jpg K854135 - HEWLETT PACKARD ULTRASOUND TRANSDUCER 21230A K854135 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Dec 1985. https://www.510kdatabase.net/k853711/ 1985-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k853711-50-mhz-intracavitary-sector-probe-fda-510k.jpg K853711 - 5.0 MHZ INTRACAVITARY SECTOR PROBE K853711 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: General Electric Co.. Cleared Dec 1985. https://www.510kdatabase.net/k854253/ 1985-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k854253-root-canal-filling-resin-fda-510k.jpg K854253 - ROOT CANAL FILLING RESIN K854253 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Dec 1985. https://www.510kdatabase.net/k854280/ 1985-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k854280-clirans-taf-hollow-fiber-dialyzer-fda-510k.jpg K854280 - CLIRANS TAF HOLLOW FIBER DIALYZER K854280 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Terumo Medical Corp.. Cleared Dec 1985. https://www.510kdatabase.net/k854586/ 1985-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k854586-hollow-fiber-dialyzer-fda-510k.jpg K854586 - HOLLOW FIBER DIALYZER K854586 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Dec 1985. https://www.510kdatabase.net/k854651/ 1985-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k854651-paraamax-chloride-determination-by-ise-fda-510k.jpg K854651 - PARAAMAX CHLORIDE DETERMINATION BY ISE K854651 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Dec 1985. https://www.510kdatabase.net/k854554/ 1985-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k854554-delta-lite-casting-resin-fda-510k.jpg K854554 - DELTA-LITE CASTING RESIN K854554 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Dec 1985. https://www.510kdatabase.net/k853249/ 1985-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k853249-rt3600115v-rt3600220240v-fda-510k.jpg K853249 - RT3600(115V) RT3600(220/240V) K853249 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Dec 1985. https://www.510kdatabase.net/k853661/ 1985-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k853661-millargalante-precoated-total-knee-fda-510k.jpg K853661 - MILLAR/GALANTE PRECOATED TOTAL KNEE K853661 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Dec 1985. https://www.510kdatabase.net/k854069/ 1985-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k854069-polyflex-483-09-endocardial-fda-510k.jpg K854069 - POLYFLEX 483-09 ENDOCARDIAL IMPLANTABLE PACINGLEAD K854069 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Dec 1985. https://www.510kdatabase.net/k852266/ 1985-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k852266-abbott-strep-a-psd-fda-510k.jpg K852266 - ABBOTT STREP A P.S.D. K852266 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Dec 1985. https://www.510kdatabase.net/k853120/ 1985-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k853120-additive-extension-syringe-fda-510k.jpg K853120 - ADDITIVE EXTENSION SYRINGE K853120 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Dec 1985. https://www.510kdatabase.net/k854057/ 1985-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k854057-paragon-electrophoresis-sys-fda-510k.jpg K854057 - PARAGON ELECTROPHORESIS SYS LIPOPROTEIN REAGENT TE K854057 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Dec 1985. https://www.510kdatabase.net/k854210/ 1985-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k854210-terumo-sensibead-eia-colorimeter-fda-510k.jpg K854210 - TERUMO SENSIBEAD EIA COLORIMETER K854210 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Terumo Medical Corp.. Cleared Dec 1985. https://www.510kdatabase.net/k854585/ 1985-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k854585-ultrazyme-plus-systemate-ldh-fda-510k.jpg K854585 - ULTRAZYME PLUS & SYSTEMATE LDH K854585 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Dec 1985. https://www.510kdatabase.net/k853398/ 1985-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k853398-medtronic-model-5062-fda-510k.jpg K853398 - MEDTRONIC MODEL 5062 K853398 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Dec 1985. https://www.510kdatabase.net/k853517/ 1985-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k853517-lifeline-endocardial-unipolar-lead-483-fda-510k.jpg K853517 - LIFELINE ENDOCARDIAL UNIPOLAR LEAD 483-08 K853517 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Dec 1985. https://www.510kdatabase.net/k853521/ 1985-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k853521-polyflex-implantable-pacing-lead-476-07-fda-510k.jpg K853521 - POLYFLEX IMPLANTABLE PACING LEAD-476-07 K853521 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Dec 1985. https://www.510kdatabase.net/k854071/ 1985-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k854071-polyflex-493-07-endocardial-fda-510k.jpg K854071 - POLYFLEX 493-07 ENDOCARDIAL IMPLANTABLE PAC-LEAD K854071 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Dec 1985. https://www.510kdatabase.net/k854501/ 1985-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k854501-ckoptimized-reagent-fda-510k.jpg K854501 - CK(OPTIMIZED) REAGENT K854501 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Dec 1985. https://www.510kdatabase.net/k854214/ 1985-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k854214-multicor-ii-402b-402c-multiprogram-fda-510k.jpg K854214 - MULTICOR II 402B & 402C MULTIPROGRAM. CARDIAC PACE K854214 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Dec 1985. https://www.510kdatabase.net/k853881/ 1985-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k853881-the-travenol-5-mlhr-infusor-fda-510k.jpg K853881 - THE TRAVENOL 5 ML/HR INFUSOR K853881 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Dec 1985. https://www.510kdatabase.net/k854215/ 1985-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k854215-dynafeed-fda-510k.jpg K854215 - DYNAFEED K854215 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medline Industries, Inc.. Cleared Dec 1985. https://www.510kdatabase.net/k854517/ 1985-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k854517-new-travenol-roller-clamp-solution-fda-510k.jpg K854517 - NEW TRAVENOL ROLLER CLAMP-SOLUTION ADMIN. SET K854517 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Dec 1985. https://www.510kdatabase.net/k854474/ 1985-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k854474-external-ventricular-drainagemonitoringl-fda-510k.jpg K854474 - EXTERNAL VENTRICULAR DRAINAGE/MONITORING/LUMBAR SE K854474 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cordis Corp.. Cleared Nov 1985. https://www.510kdatabase.net/k854050/ 1985-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k854050-excel-bracket-adhesive-fda-510k.jpg K854050 - EXCEL BRACKET ADHESIVE K854050 is a FDA 510(k) cleared dental medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Nov 1985. https://www.510kdatabase.net/k854345/ 1985-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k854345-technicon-ra-500-system-fda-510k.jpg K854345 - TECHNICON RA-500 SYSTEM K854345 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Nov 1985. https://www.510kdatabase.net/k853020/ 1985-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k853020-porocoat-synatomic-unicondylar-knee-fda-510k.jpg K853020 - POROCOAT SYNATOMIC UNICONDYLAR KNEE K853020 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Nov 1985. https://www.510kdatabase.net/k853886/ 1985-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k853886-pca-universal-acetabular-component-fda-510k.jpg K853886 - P.C.A. UNIVERSAL ACETABULAR COMPONENT SYSTEM K853886 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Nov 1985. https://www.510kdatabase.net/k854419/ 1985-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k854419-tdx-cortisol-fda-510k.jpg K854419 - TDX CORTISOL K854419 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1985. https://www.510kdatabase.net/k854421/ 1985-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k854421-tdx-r-opiates-fda-510k.jpg K854421 - TDX R OPIATES K854421 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1985. https://www.510kdatabase.net/k854502/ 1985-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k854502-altoptimized-reagent-fda-510k.jpg K854502 - ALT(OPTIMIZED) REAGENT K854502 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Nov 1985. https://www.510kdatabase.net/k854503/ 1985-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k854503-astoptimized-reagent-fda-510k.jpg K854503 - AST(OPTIMIZED) REAGENT K854503 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Nov 1985. https://www.510kdatabase.net/k854341/ 1985-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k854341-delta-lite-casting-resin-fda-510k.jpg K854341 - DELTA-LITE CASTING RESIN K854341 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Nov 1985. https://www.510kdatabase.net/k854424/ 1985-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k854424-bard-parker-150cc-bellows-reservoir-fda-510k.jpg K854424 - BARD PARKER 150CC BELLOWS RESERVOIR K854424 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Nov 1985. https://www.510kdatabase.net/k851244/ 1985-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k851244-greco-harvey-surfactant-bonded-cath-fda-510k.jpg K851244 - GRECO-HARVEY SURFACTANT BONDED CATH FOR ANESTHESIO K851244 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cook, Inc.. Cleared Nov 1985. https://www.510kdatabase.net/k853707/ 1985-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k853707-dicor-castable-ceramic-all-porcelain-fda-510k.jpg K853707 - DICOR CASTABLE CERAMIC-ALL PORCELAIN BRIDGES K853707 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Nov 1985. https://www.510kdatabase.net/k854243/ 1985-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k854243-es-22-fda-510k.jpg K854243 - ES 22 K854243 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Nov 1985. https://www.510kdatabase.net/k853408/ 1985-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k853408-collar-less-aml-hip-fda-510k.jpg K853408 - COLLAR LESS AML HIP K853408 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Nov 1985. https://www.510kdatabase.net/k853503/ 1985-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k853503-shiley-3l-cardiotomy-reservoir-fda-510k.jpg K853503 - SHILEY 3L CARDIOTOMY RESERVOIR K853503 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Nov 1985. https://www.510kdatabase.net/k853698/ 1985-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k853698-scotchprime-ceramic-primer-fda-510k.jpg K853698 - SCOTCHPRIME CERAMIC PRIMER K853698 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Nov 1985. https://www.510kdatabase.net/k854097/ 1985-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k854097-sceptor-pseudomonas-plus-micid-panel-fda-510k.jpg K854097 - SCEPTOR PSEUDOMONAS PLUS MIC/ID PANEL K854097 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Nov 1985. https://www.510kdatabase.net/k854098/ 1985-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k854098-sceptor-pseudomonas-plus-mic-panel-fda-510k.jpg K854098 - SCEPTOR PSEUDOMONAS PLUS MIC PANEL K854098 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Nov 1985. https://www.510kdatabase.net/k854099/ 1985-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k854099-sceptor-gram-negative-urine-isolate-fda-510k.jpg K854099 - SCEPTOR GRAM NEGATIVE URINE ISOLATE MIC/ID PANEL K854099 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Nov 1985. https://www.510kdatabase.net/k854100/ 1985-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k854100-sceptor-gram-positive-micid-panel-fda-510k.jpg K854100 - SCEPTOR GRAM POSITIVE MIC/ID PANEL K854100 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Nov 1985. https://www.510kdatabase.net/k854101/ 1985-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k854101-sceptor-gram-positive-mic-panel-fda-510k.jpg K854101 - SCEPTOR GRAM POSITIVE MIC PANEL K854101 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Nov 1985. https://www.510kdatabase.net/k854102/ 1985-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k854102-sceptor-enteric-mic-panel-fda-510k.jpg K854102 - SCEPTOR ENTERIC MIC PANEL K854102 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Nov 1985. https://www.510kdatabase.net/k854103/ 1985-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k854103-sceptor-enteric-micid-panel-fda-510k.jpg K854103 - SCEPTOR ENTERIC MIC/ID PANEL K854103 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Nov 1985. https://www.510kdatabase.net/k853986/ 1985-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k853986-thromboplastin-r-reagent-fda-510k.jpg K853986 - THROMBOPLASTIN-R REAGENT K853986 is a FDA 510(k) cleared hematology medical device. Manufacturer: American Dade. Cleared Nov 1985. https://www.510kdatabase.net/k854066/ 1985-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k854066-double-antibody-c-peptide-ria-kit-fda-510k.jpg K854066 - DOUBLE ANTIBODY C-PEPTIDE RIA KIT K854066 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Nov 1985. https://www.510kdatabase.net/k854093/ 1985-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k854093-leuco-prep-fda-510k.jpg K854093 - LEUCO PREP K854093 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Nov 1985. https://www.510kdatabase.net/k854138/ 1985-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k854138-kodakektachem-dtr-module-fda-510k.jpg K854138 - KODAKEKTACHEM DTR MODULE K854138 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Nov 1985. https://www.510kdatabase.net/k854298/ 1985-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k854298-iron-fda-510k.jpg K854298 - IRON K854298 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Nov 1985. https://www.510kdatabase.net/k852339/ 1985-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k852339-suprima-model-254-22-fda-510k.jpg K852339 - SUPRIMA MODEL 254-22 K852339 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Nov 1985. https://www.510kdatabase.net/k852340/ 1985-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k852340-suprima-model-254-24-fda-510k.jpg K852340 - SUPRIMA MODEL 254-24 K852340 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Nov 1985. https://www.510kdatabase.net/k853523/ 1985-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k853523-visible-light-cured-orthodontic-adhesive-fda-510k.jpg K853523 - VISIBLE LIGHT CURED ORTHODONTIC ADHESIVE K853523 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Nov 1985. https://www.510kdatabase.net/k854042/ 1985-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k854042-resin-tray-impression-material-fda-510k.jpg K854042 - RESIN TRAY IMPRESSION MATERIAL K854042 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Nov 1985. https://www.510kdatabase.net/k853322/ 1985-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k853322-medtronic-access-port-model-8500-fda-510k.jpg K853322 - MEDTRONIC ACCESS PORT MODEL 8500 K853322 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medtronic Vascular. Cleared Nov 1985. https://www.510kdatabase.net/k853830/ 1985-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k853830-sliding-reconstitution-device-wadmix-fda-510k.jpg K853830 - SLIDING RECONSTITUTION DEVICE W/ADMIX VIALEX PLAST K853830 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Nov 1985. https://www.510kdatabase.net/k841245/ 1985-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k841245-enzygnost-antiherpes-simplex-virus-fda-510k.jpg K841245 - ENZYGNOST ANTIHERPES SIMPLEX VIRUS K841245 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Nov 1985. https://www.510kdatabase.net/k853518/ 1985-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k853518-lifeline-endocardial-bipolar-lead-476-06-fda-510k.jpg K853518 - LIFELINE ENDOCARDIAL BIPOLAR LEAD 476-06 K853518 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Nov 1985. https://www.510kdatabase.net/k854139/ 1985-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k854139-kodak-ektachem-clinical-chemistry-fda-510k.jpg K854139 - KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE HB K854139 is a FDA 510(k) cleared hematology medical device. Manufacturer: Eastman Kodak Company. Cleared Nov 1985. https://www.510kdatabase.net/k854152/ 1985-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k854152-technicon-ra-systems-for-triglycerides-fda-510k.jpg K854152 - TECHNICON RA SYSTEMS FOR TRIGLYCERIDES ANALYSIS IN K854152 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Nov 1985. https://www.510kdatabase.net/k854163/ 1985-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k854163-tdx-cocaine-metabolite-fda-510k.jpg K854163 - TDX COCAINE METABOLITE K854163 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1985. https://www.510kdatabase.net/k854167/ 1985-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k854167-tdx-phencyclidine-fda-510k.jpg K854167 - TDX PHENCYCLIDINE K854167 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1985. https://www.510kdatabase.net/k842905/ 1985-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k842905-travenol-multiday-infusor-2c1080-fda-510k.jpg K842905 - TRAVENOL MULTIDAY INFUSOR 2C1080 K842905 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Nov 1985. https://www.510kdatabase.net/k852688/ 1985-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k852688-medtronics-models-832083228329-fda-510k.jpg K852688 - MEDTRONICS MODELS 8320/8322/8329 K852688 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Nov 1985. https://www.510kdatabase.net/k852748/ 1985-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k852748-cordis-models-336a336b337a-334-cardiac-fda-510k.jpg K852748 - CORDIS MODELS 336A,336B,337A & 334 CARDIAC PACEMAK K852748 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Nov 1985. https://www.510kdatabase.net/k853259/ 1985-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k853259-malloryhead-total-hip-system-fda-510k.jpg K853259 - MALLORY/HEAD TOTAL HIP SYSTEM K853259 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Nov 1985. https://www.510kdatabase.net/k852362/ 1985-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k852362-urological-ultrasound-diagnostic-fda-510k.jpg K852362 - UROLOGICAL ULTRASOUND DIAGNOSTIC SYS/EQUIP. SSD-52 K852362 is a FDA 510(k) cleared radiology medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Oct 1985. https://www.510kdatabase.net/k853431/ 1985-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k853431-dental-cement-fda-510k.jpg K853431 - DENTAL CEMENT K853431 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Oct 1985. https://www.510kdatabase.net/k853769/ 1985-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k853769-irregular-curve-tracing-revisition-fda-510k.jpg K853769 - IRREGULAR CURVE TRACING REVISITION & DOPPLER K853769 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Oct 1985. https://www.510kdatabase.net/k852410/ 1985-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k852410-mevaplan-and-somados-fda-510k.jpg K852410 - MEVAPLAN AND SOMADOS K852410 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 1985. https://www.510kdatabase.net/k853681/ 1985-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k853681-sigma-610-for-protein-in-urine-csf-fda-510k.jpg K853681 - SIGMA 610 FOR PROTEIN IN URINE & CSF K853681 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Oct 1985. https://www.510kdatabase.net/k853854/ 1985-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k853854-astra-systems-cholesterol-reagent-fda-510k.jpg K853854 - ASTRA SYSTEMS CHOLESTEROL REAGENT K853854 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Oct 1985. https://www.510kdatabase.net/k853879/ 1985-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k853879-tdx-amphetamine-methamphetamine-fda-510k.jpg K853879 - TDX AMPHETAMINE METHAMPHETAMINE K853879 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1985. https://www.510kdatabase.net/k854025/ 1985-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k854025-hitachi-704-fda-510k.jpg K854025 - HITACHI 704 K854025 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Oct 1985. https://www.510kdatabase.net/k854039/ 1985-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k854039-laser-aso-kit-fda-510k.jpg K854039 - LASER ASO KIT K854039 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Oct 1985. https://www.510kdatabase.net/k854044/ 1985-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k854044-tdx-barbiturates-fda-510k.jpg K854044 - TDX BARBITURATES K854044 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1985. https://www.510kdatabase.net/k853519/ 1985-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k853519-lifeline-endocardial-bipolar-lead-484-03-fda-510k.jpg K853519 - LIFELINE ENDOCARDIAL BIPOLAR LEAD 484-03 K853519 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Oct 1985. https://www.510kdatabase.net/k852980/ 1985-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k852980-ocs-2-colposcope-fda-510k.jpg K852980 - OCS-2 COLPOSCOPE K852980 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Olympus Corp.. Cleared Oct 1985. https://www.510kdatabase.net/k854061/ 1985-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k854061-syva-mycotrans-mycoplasma-transport-fda-510k.jpg K854061 - SYVA MYCOTRANS MYCOPLASMA TRANSPORT SYSTEM K854061 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Syva Co.. Cleared Oct 1985. https://www.510kdatabase.net/k854064/ 1985-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k854064-bcye-buffered-charcoal-yeast-extract-fda-510k.jpg K854064 - BCYE (BUFFERED CHARCOAL YEAST EXTRACT) AGAR K854064 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1985. https://www.510kdatabase.net/k852392/ 1985-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k852392-edctitan-geliso-total-cpk-isoenzyme-fda-510k.jpg K852392 - EDC/TITAN GELISO-TOTAL CPK ISOENZYME PROCEDURE K852392 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Oct 1985. https://www.510kdatabase.net/k852971/ 1985-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k852971-9431-teletrace-telephone-ekg-transmitter-fda-510k.jpg K852971 - #9431 TELETRACE, TELEPHONE, EKG TRANSMITTER K852971 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Oct 1985. https://www.510kdatabase.net/k853896/ 1985-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k853896-gram-stain-kit-fda-510k.jpg K853896 - GRAM STAIN KIT K853896 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Oct 1985. https://www.510kdatabase.net/k853860/ 1985-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k853860-repair-kit-quinton-triple-lumen-right-fda-510k.jpg K853860 - REPAIR KIT QUINTON TRIPLE LUMEN RIGHT ATRIAL CATHE K853860 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Oct 1985. https://www.510kdatabase.net/k850884/ 1985-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k850884-argyle-polyurethane-umbilical-vessel-fda-510k.jpg K850884 - ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER K850884 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Oct 1985. https://www.510kdatabase.net/k852467/ 1985-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k852467-vial-vent-filter-fda-510k.jpg K852467 - VIAL VENT FILTER K852467 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Oct 1985. https://www.510kdatabase.net/k853251/ 1985-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k853251-j-j-cardiovascular-maxima-hollow-fiber-fda-510k.jpg K853251 - J & J CARDIOVASCULAR MAXIMA HOLLOW FIBER OXYGENATO K853251 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Oct 1985. https://www.510kdatabase.net/k853834/ 1985-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k853834-vision-theophylline-fda-510k.jpg K853834 - VISION THEOPHYLLINE K853834 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1985. https://www.510kdatabase.net/k853978/ 1985-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k853978-tdx-amylase-fda-510k.jpg K853978 - TDX AMYLASE K853978 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1985. https://www.510kdatabase.net/k854009/ 1985-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k854009-abuscreen-radioimmunoassay-for-fda-510k.jpg K854009 - ABUSCREEN RADIOIMMUNOASSAY FOR AMPHETAMINE-HIGH SP K854009 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Oct 1985. https://www.510kdatabase.net/k852984/ 1985-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k852984-shiley-csd-extension-line-with-filter-fda-510k.jpg K852984 - SHILEY CSD EXTENSION LINE WITH FILTER K852984 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Oct 1985. https://www.510kdatabase.net/k853080/ 1985-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k853080-william-harvey-hybid-oxygenator-h-1700-fda-510k.jpg K853080 - WILLIAM HARVEY HYBID OXYGENATOR H-1700 K853080 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 1985. https://www.510kdatabase.net/k853410/ 1985-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k853410-model-492-03-polyflex-implantable-fda-510k.jpg K853410 - MODEL 492-03 POLYFLEX IMPLANTABLE PACING LEAD K853410 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Oct 1985. https://www.510kdatabase.net/k853439/ 1985-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k853439-model-43130a-defibrillator-fda-510k.jpg K853439 - MODEL 43130A DEFIBRILLATOR K853439 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Oct 1985. https://www.510kdatabase.net/k853818/ 1985-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k853818-medtronic-model-6405-fda-510k.jpg K853818 - MEDTRONIC MODEL 6405 K853818 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Oct 1985. https://www.510kdatabase.net/k852865/ 1985-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k852865-optical-disc-unit-fda-510k.jpg K852865 - OPTICAL DISC UNIT K852865 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Oct 1985. https://www.510kdatabase.net/k853520/ 1985-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k853520-lifeline-endocardial-unipolar-487-06-fda-510k.jpg K853520 - LIFELINE ENDOCARDIAL UNIPOLAR 487-06 TLE LEAD K853520 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Oct 1985. https://www.510kdatabase.net/k852293/ 1985-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k852293-bard-parker-biliary-balloon-catheter-fda-510k.jpg K852293 - BARD-PARKER BILIARY BALLOON CATHETER K852293 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1985. https://www.510kdatabase.net/k852520/ 1985-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k852520-aca-fibrin-degradation-prod-analytical-fda-510k.jpg K852520 - ACA FIBRIN DEGRADATION PROD ANALYTICAL TEST PACK K852520 is a FDA 510(k) cleared hematology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Oct 1985. https://www.510kdatabase.net/k853358/ 1985-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k853358-reliance-pendulum-ophthalmic-delivery-fda-510k.jpg K853358 - RELIANCE PENDULUM OPHTHALMIC DELIVERY SYSTEM K853358 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Dentsply Intl.. Cleared Oct 1985. https://www.510kdatabase.net/k853550/ 1985-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k853550-travenol-capd-y-set-5c4354-fda-510k.jpg K853550 - TRAVENOL CAPD Y SET 5C4354 K853550 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Oct 1985. https://www.510kdatabase.net/k853871/ 1985-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k853871-qca-enzymatic-cholesterol-fda-510k.jpg K853871 - QCA ENZYMATIC CHOLESTEROL K853871 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1985. https://www.510kdatabase.net/k853853/ 1985-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k853853-technicon-chem-1-sys-analytes-fda-510k.jpg K853853 - TECHNICON CHEM 1 SYS ANALYTES MAGNESIUM GGT, URIC K853853 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Oct 1985. https://www.510kdatabase.net/k852391/ 1985-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k852391-edctitan-geliso-dot-total-ldh-fda-510k.jpg K852391 - EDC/TITAN GELISO-DOT TOTAL LDH ISOENZYME PROCEDURE K852391 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Oct 1985. https://www.510kdatabase.net/k853411/ 1985-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k853411-model-486-03-poly-flex-implantable-fda-510k.jpg K853411 - MODEL 486-03 POLY FLEX IMPLANTABLE PACING LEAD K853411 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Oct 1985. https://www.510kdatabase.net/k853835/ 1985-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k853835-emit-qst-carbamazepine-assay-fda-510k.jpg K853835 - EMIT QST CARBAMAZEPINE ASSAY K853835 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Oct 1985. https://www.510kdatabase.net/k852780/ 1985-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k852780-bcd-plus-blood-cardioplegia-syshereaf-fda-510k.jpg K852780 - BCD PLUS BLOOD CARDIOPLEGIA SYS(HEREAF REFER DEV) K852780 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Sep 1985. https://www.510kdatabase.net/k852946/ 1985-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k852946-sera-aris-pheno-reag-strip-test-mod-fda-510k.jpg K852946 - SERA ARIS PHENO REAG STRIP, TEST MOD CAL & CLT K852946 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Sep 1985. https://www.510kdatabase.net/k852608/ 1985-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k852608-spectra-400-extended-surveillance-fda-510k.jpg K852608 - SPECTRA 400 EXTENDED SURVEILLANCE & ALERT SYSTEM K852608 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Sep 1985. https://www.510kdatabase.net/k853539/ 1985-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k853539-abbott-testpack-hcgurine-diagnostic-kit-fda-510k.jpg K853539 - ABBOTT TESTPACK HCG(URINE) DIAGNOSTIC KIT K853539 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1985. https://www.510kdatabase.net/k853359/ 1985-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k853359-reliance-1379-fda-510k.jpg K853359 - RELIANCE 1379 K853359 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Dentsply Intl.. Cleared Sep 1985. https://www.510kdatabase.net/k852612/ 1985-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k852612-metronic-model-f7700-heart-valve-sizers-fda-510k.jpg K852612 - METRONIC MODEL F7700 HEART VALVE SIZERS K852612 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Sep 1985. https://www.510kdatabase.net/k851301/ 1985-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k851301-target-catb7850aa-b7850ab-b7850b-fda-510k.jpg K851301 - TARGET CAT#B7850AA & B7850AB & B7850B K851301 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Sep 1985. https://www.510kdatabase.net/k853543/ 1985-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k853543-davol-retrieval-balloon-catheter-fda-510k.jpg K853543 - DAVOL RETRIEVAL BALLOON CATHETER K853543 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Sep 1985. https://www.510kdatabase.net/k851807/ 1985-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k851807-rt2600115v220240v-h4008a-h4008ae-fda-510k.jpg K851807 - RT2600(115V)(220/240V) #H4008A & H4008AE K851807 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Sep 1985. https://www.510kdatabase.net/k852570/ 1985-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k852570-50-mhz-linear-array-model-83-39-517-fda-510k.jpg K852570 - 5.0 MHZ LINEAR ARRAY, MODEL 83, 39, 517 K852570 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 1985. https://www.510kdatabase.net/k852571/ 1985-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k852571-35-mhz-linear-array-model-no-83-39-509-fda-510k.jpg K852571 - 3.5 MHZ LINEAR ARRAY, MODEL NO. 83, 39, 509 K852571 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 1985. https://www.510kdatabase.net/k852572/ 1985-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k852572-35-mhz-cw-doppler-probe-model-no-8421802-fda-510k.jpg K852572 - 3.5 MHZ CW DOPPLER PROBE MODEL NO. 8421802 K852572 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 1985. https://www.510kdatabase.net/k852750/ 1985-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k852750-tegaderm-plus-transparent-dressing-952x-fda-510k.jpg K852750 - TEGADERM PLUS TRANSPARENT DRESSING #952X K852750 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3M Company. Cleared Sep 1985. https://www.510kdatabase.net/k853650/ 1985-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k853650-auto-suture-titanium-hemostatic-clip-fda-510k.jpg K853650 - AUTO SUTURE TITANIUM HEMOSTATIC CLIP K853650 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Sep 1985. https://www.510kdatabase.net/k853655/ 1985-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k853655-new-jersey-modular-femoral-hip-fda-510k.jpg K853655 - NEW JERSEY MODULAR FEMORAL HIP K853655 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Sep 1985. https://www.510kdatabase.net/k853548/ 1985-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k853548-stratus-procainamide-fluorometric-fda-510k.jpg K853548 - STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNOASS K853548 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Sep 1985. https://www.510kdatabase.net/k853628/ 1985-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k853628-simultrac-free-t457cotsh125i-fda-510k.jpg K853628 - SIMULTRAC FREE T4(57CO)/TSH[125I] RADIOIMMUNOASSAY K853628 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1985. https://www.510kdatabase.net/k852294/ 1985-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k852294-bard-parker-occlusion-balloon-catheter-fda-510k.jpg K852294 - BARD-PARKER OCCLUSION BALLOON CATHETER K852294 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1985. https://www.510kdatabase.net/k852472/ 1985-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k852472-abbott-rsv-eia-fda-510k.jpg K852472 - ABBOTT RSV EIA K852472 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1985. https://www.510kdatabase.net/k851913/ 1985-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k851913-cordis-high-torque-temp-pervenous-lead-fda-510k.jpg K851913 - CORDIS HIGH-TORQUE TEMP. PERVENOUS LEAD W/DEPTH MA K851913 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Sep 1985. https://www.510kdatabase.net/k852133/ 1985-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k852133-reflotron-system-fda-510k.jpg K852133 - REFLOTRON SYSTEM K852133 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Sep 1985. https://www.510kdatabase.net/k852478/ 1985-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k852478-enzygnost-anti-cmv-igg-test-fda-510k.jpg K852478 - ENZYGNOST + ANTI-CMV IGG TEST K852478 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Sep 1985. https://www.510kdatabase.net/k852513/ 1985-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k852513-115-gk-bard-care-translu-ventricular-fda-510k.jpg K852513 - 115-GK BARD CARE TRANSLU VENTRICULAR PACING LEAD K852513 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Sep 1985. https://www.510kdatabase.net/k852779/ 1985-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k852779-microtrak-chlamydia-trachomatis-dir-fda-510k.jpg K852779 - MICROTRAK CHLAMYDIA TRACHOMATIS DIR SPECIMEN TEST K852779 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Syva Co.. Cleared Sep 1985. https://www.510kdatabase.net/k853205/ 1985-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k853205-proximal-porocoat-modified-medical-fda-510k.jpg K853205 - PROXIMAL POROCOAT MODIFIED MEDICAL ASPECT AML HIP K853205 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Sep 1985. https://www.510kdatabase.net/k853215/ 1985-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k853215-accu-flo-pressure-valve-fda-510k.jpg K853215 - ACCU-FLO PRESSURE VALVE K853215 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Sep 1985. https://www.510kdatabase.net/k853547/ 1985-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k853547-stratus-n-acetylprocainamide-fda-510k.jpg K853547 - STRATUS N-ACETYLPROCAINAMIDE FLUOROMETRIC ENZYME I K853547 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Sep 1985. https://www.510kdatabase.net/k853656/ 1985-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k853656-qca-enzymatic-glucose-fda-510k.jpg K853656 - QCA ENZYMATIC GLUCOSE K853656 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1985. https://www.510kdatabase.net/k853677/ 1985-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k853677-tdx-rea-bun-fda-510k.jpg K853677 - TDX REA BUN K853677 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1985. https://www.510kdatabase.net/k852514/ 1985-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k852514-model-78560a-central-station-patient-fda-510k.jpg K852514 - MODEL 78560A CENTRAL STATION PATIENT INFO SYS K852514 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Sep 1985. https://www.510kdatabase.net/k853486/ 1985-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k853486-olympus-rigid-percutaneous-nephroscope-fda-510k.jpg K853486 - OLYMPUS RIGID PERCUTANEOUS NEPHROSCOPE K853486 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Corp.. Cleared Sep 1985. https://www.510kdatabase.net/k851242/ 1985-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k851242-greco-harvey-surfactant-bonded-fda-510k.jpg K851242 - GRECO-HARVEY SURFACTANT BONDED CATHETER FOR GASTRO K851242 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook, Inc.. Cleared Sep 1985. https://www.510kdatabase.net/k853310/ 1985-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k853310-simplex-enhancement-mixer-fda-510k.jpg K853310 - SIMPLEX ENHANCEMENT MIXER K853310 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Sep 1985. https://www.510kdatabase.net/k853546/ 1985-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k853546-abbott-cation-supplement-solution-fda-510k.jpg K853546 - ABBOTT CATION SUPPLEMENT SOLUTION K853546 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1985. https://www.510kdatabase.net/k852545/ 1985-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k852545-band-aid-brand-adhesive-bandages-fda-510k.jpg K852545 - BAND-AID BRAND ADHESIVE BANDAGES K852545 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Sep 1985. https://www.510kdatabase.net/k852845/ 1985-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k852845-prostatic-acid-phosphatase-fda-510k.jpg K852845 - PROSTATIC ACID PHOSPHATASE RADIOIMMUNOASSAY K852845 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Sep 1985. https://www.510kdatabase.net/k853531/ 1985-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k853531-ion-selective-electrode-subsystem-fda-510k.jpg K853531 - ION SELECTIVE ELECTRODE SUBSYSTEM PARAMAX ANALYZER K853531 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Sep 1985. https://www.510kdatabase.net/k852611/ 1985-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k852611-test-urobilinogen-in-urine-leukocytes-fda-510k.jpg K852611 - TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE K852611 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Sep 1985. https://www.510kdatabase.net/k850368/ 1985-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k850368-sigms-b-hydroxybutarate-procedure-no-fda-510k.jpg K850368 - SIGMS B-HYDROXYBUTARATE PROCEDURE NO. 310-UV K850368 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Aug 1985. https://www.510kdatabase.net/k844814/ 1985-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k844814-biopore-493-05-endocardial-implantable-fda-510k.jpg K844814 - BIOPORE 493-05 ENDOCARDIAL IMPLANTABLE PACING LEAD K844814 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Aug 1985. https://www.510kdatabase.net/k844948/ 1985-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k844948-syva-solid-phase-columns-fda-510k.jpg K844948 - SYVA SOLID PHASE COLUMNS K844948 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Aug 1985. https://www.510kdatabase.net/k850968/ 1985-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k850968-medtronic-model-4016-bipolar-fda-510k.jpg K850968 - MEDTRONIC MODEL 4016 BIPOLAR ENDOCARDIAL SCREW-IN K850968 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Aug 1985. https://www.510kdatabase.net/k853461/ 1985-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k853461-coagulation-factor-ix-deficient-fda-510k.jpg K853461 - COAGULATION FACTOR IX DEFICIENT SUBSTRATE PLASMA K853461 is a FDA 510(k) cleared hematology medical device. Manufacturer: American Dade. Cleared Aug 1985. https://www.510kdatabase.net/k853462/ 1985-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k853462-coagulation-factor-viii-deficient-fda-510k.jpg K853462 - COAGULATION FACTOR VIII DEFICIENT SUBSTRATE PLASMA K853462 is a FDA 510(k) cleared hematology medical device. Manufacturer: American Dade. Cleared Aug 1985. https://www.510kdatabase.net/k853534/ 1985-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k853534-bbl-campy-pouch-fda-510k.jpg K853534 - BBL CAMPY POUCH K853534 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1985. https://www.510kdatabase.net/k852878/ 1985-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k852878-the-dpc-monoclonal-eia-total-ige-kit-fda-510k.jpg K852878 - THE DPC MONOCLONAL EIA TOTAL IGE KIT K852878 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Aug 1985. https://www.510kdatabase.net/k852815/ 1985-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k852815-triple-lumen-right-atrial-catheter-fda-510k.jpg K852815 - TRIPLE LUMEN RIGHT ATRIAL CATHETER K852815 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Aug 1985. https://www.510kdatabase.net/k851703/ 1985-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k851703-glucostix-reagent-strips-glucometer-fda-510k.jpg K851703 - GLUCOSTIX REAGENT STRIPS & GLUCOMETER REFLECT-PHOT K851703 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Aug 1985. https://www.510kdatabase.net/k853152/ 1985-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k853152-monoject-sample-capillary-plasma-sep-fda-510k.jpg K853152 - MONOJECT SAMPLE CAPILLARY PLASMA SEP W/LITH HEPAR K853152 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sherwood Medical Co.. Cleared Aug 1985. https://www.510kdatabase.net/k853404/ 1985-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k853404-qca-potassium-test-kit-fda-510k.jpg K853404 - QCA POTASSIUM TEST KIT K853404 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1985. https://www.510kdatabase.net/k850482/ 1985-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k850482-datascope-85-french-electrode-intra-fda-510k.jpg K850482 - DATASCOPE 8.5 FRENCH ELECTRODE INTRA-AORTIC BALLOO K850482 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Aug 1985. https://www.510kdatabase.net/k852198/ 1985-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k852198-aml-proximal-porocoat-femoral-hip-fda-510k.jpg K852198 - AML PROXIMAL POROCOAT FEMORAL HIP K852198 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Aug 1985. https://www.510kdatabase.net/k852388/ 1985-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k852388-mahurkar-subclavian-catheter-insertion-fda-510k.jpg K852388 - MAHURKAR SUBCLAVIAN CATHETER INSERTION KIT K852388 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Aug 1985. https://www.510kdatabase.net/k852585/ 1985-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k852585-porous-apfmodular-femoral-component-fda-510k.jpg K852585 - POROUS APF/MODULAR FEMORAL COMPONENT K852585 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Aug 1985. https://www.510kdatabase.net/k853261/ 1985-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k853261-laser-rbp-laserretinol-binding-protein-fda-510k.jpg K853261 - LASER RBP LASER(RETINOL BINDING PROTEIN REAGENTS) K853261 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Aug 1985. https://www.510kdatabase.net/k852481/ 1985-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k852481-uni-pak-500-analyzer-chemistry-reagent-fda-510k.jpg K852481 - UNI PAK 500 ANALYZER + CHEMISTRY REAGENT ITEM K852481 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Aug 1985. https://www.510kdatabase.net/k852546/ 1985-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k852546-howmedica-cemented-flanged-acetabular-fda-510k.jpg K852546 - HOWMEDICA CEMENTED FLANGED ACETABULAR COMPONENT SY K852546 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Aug 1985. https://www.510kdatabase.net/k852888/ 1985-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k852888-olympus-rigid-ureterorenoscope-fda-510k.jpg K852888 - OLYMPUS RIGID URETERORENOSCOPE K852888 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Corp.. Cleared Aug 1985. https://www.510kdatabase.net/k844913/ 1985-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k844913-cordis-pta-catheter-percutaneous-fda-510k.jpg K844913 - CORDIS PTA CATHETER-PERCUTANEOUS CATHETER K844913 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Aug 1985. https://www.510kdatabase.net/k852132/ 1985-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k852132-model-21225a-cw-copplerimaging-fda-510k.jpg K852132 - MODEL 21225A CW COPPLER/IMAGING TRANSDUCER K852132 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Aug 1985. https://www.510kdatabase.net/k852873/ 1985-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k852873-ceftazidime-30mcg-seni-disc-fda-510k.jpg K852873 - CEFTAZIDIME 30MCG. SENI-DISC K852873 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1985. https://www.510kdatabase.net/k853208/ 1985-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k853208-125i-estradiol-direct-radioimmunoassay-fda-510k.jpg K853208 - 125I ESTRADIOL DIRECT RADIOIMMUNOASSAY K853208 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Aug 1985. https://www.510kdatabase.net/k853357/ 1985-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k853357-uric-acid-reagent-fda-510k.jpg K853357 - URIC ACID REAGENT K853357 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Aug 1985. https://www.510kdatabase.net/k851947/ 1985-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k851947-ptca-guiding-catheter-fda-510k.jpg K851947 - PTCA GUIDING CATHETER K851947 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Aug 1985. https://www.510kdatabase.net/k852153/ 1985-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k852153-the-pca-two-piece-snap-lock-acetabular-fda-510k.jpg K852153 - THE P.C.A. TWO-PIECE SNAP LOCK ACETABULAR CUP K852153 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Aug 1985. https://www.510kdatabase.net/k853052/ 1985-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k853052-integrity-fda-510k.jpg K853052 - INTEGRITY K853052 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Aug 1985. https://www.510kdatabase.net/k852584/ 1985-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k852584-porous-apfcollarless-modular-femoral-fda-510k.jpg K852584 - POROUS APF/COLLARLESS MODULAR FEMORAL COMPONENT K852584 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Aug 1985. https://www.510kdatabase.net/k851982/ 1985-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k851982-kitecko-ultrasound-standoff-pad-fda-510k.jpg K851982 - KITECKO ULTRASOUND STANDOFF PAD K851982 is a FDA 510(k) cleared radiology medical device. Manufacturer: 3M Company. Cleared Aug 1985. https://www.510kdatabase.net/k852827/ 1985-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k852827-cordis-external-neural-stimulator-fda-510k.jpg K852827 - CORDIS EXTERNAL NEURAL STIMULATOR MODEL 911A K852827 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cordis Corp.. Cleared Aug 1985. https://www.510kdatabase.net/k850950/ 1985-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k850950-vision-potassium-fda-510k.jpg K850950 - VISION POTASSIUM K850950 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1985. https://www.510kdatabase.net/k851323/ 1985-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k851323-amendment-william-harvey-h-4300-fda-510k.jpg K851323 - AMENDMENT WILLIAM HARVEY H-4300 CARDIOPULMONARY SU K851323 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Aug 1985. https://www.510kdatabase.net/k852176/ 1985-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k852176-dupont-aca-fibrin-ogen-degrad-products-fda-510k.jpg K852176 - DUPONT ACA FIBRIN OGEN DEGRAD-PRODUCTS CALIBRATOR K852176 is a FDA 510(k) cleared hematology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Aug 1985. https://www.510kdatabase.net/k852449/ 1985-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k852449-howmedica-hip-sys-distal-centralizing-fda-510k.jpg K852449 - HOWMEDICA HIP SYS DISTAL CENTRALIZING SPACER K852449 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Aug 1985. https://www.510kdatabase.net/k852519/ 1985-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k852519-dupont-aca-fibrin-degradation-prod-fda-510k.jpg K852519 - DUPONT ACA FIBRIN DEGRADATION PROD CLOTTING TUBE K852519 is a FDA 510(k) cleared hematology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Aug 1985. https://www.510kdatabase.net/k852747/ 1985-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k852747-visidex-ii-reagent-strips-fda-510k.jpg K852747 - VISIDEX II REAGENT STRIPS K852747 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Aug 1985. https://www.510kdatabase.net/k853113/ 1985-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k853113-td-tricyclic-antidepressants-fda-510k.jpg K853113 - TD TRICYCLIC ANTIDEPRESSANTS K853113 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1985. https://www.510kdatabase.net/k852086/ 1985-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k852086-capiox-blood-sampling-manifold-fda-510k.jpg K852086 - CAPIOX BLOOD SAMPLING MANIFOLD K852086 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Aug 1985. https://www.510kdatabase.net/k852099/ 1985-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k852099-bard-parker-irrigation-catheter-fda-510k.jpg K852099 - BARD-PARKER IRRIGATION CATHETER K852099 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1985. https://www.510kdatabase.net/k852397/ 1985-08-09 monthly 0.5 https://www.510kdatabase.net/og-image/k852397-external-fixation-systemcat-serias-5129-fda-510k.jpg K852397 - EXTERNAL FIXATION SYSTEM(CAT. # SERIAS 5129) K852397 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Aug 1985. https://www.510kdatabase.net/k853066/ 1985-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k853066-mayfield-disposable-skull-pins-fda-510k.jpg K853066 - MAYFIELD DISPOSABLE SKULL PINS K853066 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Aug 1985. https://www.510kdatabase.net/k853010/ 1985-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k853010-cobas-reagent-for-lidocaine-calibrators-fda-510k.jpg K853010 - COBAS REAGENT FOR LIDOCAINE & CALIBRATORS K853010 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Aug 1985. https://www.510kdatabase.net/k853021/ 1985-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k853021-optimate-digoxin-test-fda-510k.jpg K853021 - OPTIMATE DIGOXIN TEST K853021 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Aug 1985. https://www.510kdatabase.net/k852356/ 1985-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k852356-medtronic-model-5561-fda-510k.jpg K852356 - MEDTRONIC MODEL 5561 K852356 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Aug 1985. https://www.510kdatabase.net/k850952/ 1985-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k850952-bard-critical-care-thermodilutin-fda-510k.jpg K850952 - BARD CRITICAL CARE THERMODILUTIN CATHETER W/INFUSI K850952 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Aug 1985. https://www.510kdatabase.net/k852927/ 1985-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k852927-tdx-cortisol-fda-510k.jpg K852927 - TDX CORTISOL K852927 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1985. https://www.510kdatabase.net/k852954/ 1985-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k852954-b-d-digital-fever-thermometer-fda-510k.jpg K852954 - B-D DIGITAL FEVER THERMOMETER K852954 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1985. https://www.510kdatabase.net/k852649/ 1985-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k852649-pressure-regulatory-connector-fda-510k.jpg K852649 - PRESSURE REGULATOR/Y CONNECTOR K852649 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Aug 1985. https://www.510kdatabase.net/k852672/ 1985-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k852672-aca-gentamicin-test-pack-fda-510k.jpg K852672 - ACA GENTAMICIN TEST PACK K852672 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Aug 1985. https://www.510kdatabase.net/k852847/ 1985-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k852847-sopheia-dhea-so4-eia-kit-fda-510k.jpg K852847 - SOPHEIA DHEA-SO4 EIA KIT K852847 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Aug 1985. https://www.510kdatabase.net/k851456/ 1985-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k851456-accu-chek-ii-fda-510k.jpg K851456 - ACCU-CHEK II K851456 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Aug 1985. https://www.510kdatabase.net/k851929/ 1985-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k851929-restore-fda-510k.jpg K851929 - RESTORE* K851929 is a FDA 510(k) cleared dental medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jul 1985. https://www.510kdatabase.net/k844818/ 1985-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k844818-normalized-hs3n-proportional-series-fda-510k.jpg K844818 - NORMALIZED HS3N PROPORTIONAL SERIES HIP STEMS K844818 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Jul 1985. https://www.510kdatabase.net/k851566/ 1985-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k851566-howmedica-femoral-component-hip-sys-6259-fda-510k.jpg K851566 - HOWMEDICA FEMORAL COMPONENT HIP SYS 6259 K851566 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jul 1985. https://www.510kdatabase.net/k851636/ 1985-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k851636-diamat-glycoslated-hemoglobin-analyzer-fda-510k.jpg K851636 - DIAMAT GLYCOSLATED HEMOGLOBIN ANALYZER SYSTEM K851636 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bio-Rad. Cleared Jul 1985. https://www.510kdatabase.net/k852193/ 1985-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k852193-porocoat-schatzker-ii-acetabulum-fda-510k.jpg K852193 - POROCOAT SCHATZKER II ACETABULUM K852193 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Depuy, Inc.. Cleared Jul 1985. https://www.510kdatabase.net/k852270/ 1985-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k852270-lifescope-8-dec-8108a-and-dec-8204a-fda-510k.jpg K852270 - LIFESCOPE 8 DEC-8108A AND DEC-8204A K852270 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Jul 1985. https://www.510kdatabase.net/k852659/ 1985-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k852659-biogloss-fda-510k.jpg K852659 - BIOGLOSS K852659 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jul 1985. https://www.510kdatabase.net/k853011/ 1985-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k853011-bactec-nr-730-bacterial-detection-system-fda-510k.jpg K853011 - BACTEC NR-730 BACTERIAL DETECTION SYSTEM K853011 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jul 1985. https://www.510kdatabase.net/k852024/ 1985-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k852024-dentin-adhesive-fda-510k.jpg K852024 - DENTIN ADHESIVE K852024 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jul 1985. https://www.510kdatabase.net/k852253/ 1985-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k852253-329-cordis-encor-prevenous-artrial-fda-510k.jpg K852253 - 329 CORDIS ENCOR PREVENOUS ARTRIAL & VENTRICULAR K852253 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Jul 1985. https://www.510kdatabase.net/k852678/ 1985-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k852678-capd-transfer-set-for-reduced-fill-fda-510k.jpg K852678 - CAPD TRANSFER SET FOR REDUCED FILL VOLUMES 5C4353 K852678 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Jul 1985. https://www.510kdatabase.net/k852964/ 1985-07-29 monthly 0.5 https://www.510kdatabase.net/og-image/k852964-pca-total-hip-femoral-component-fda-510k.jpg K852964 - P.C.A. TOTAL HIP FEMORAL COMPONENT MODIFICATION K852964 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Howmedica Corp.. Cleared Jul 1985. https://www.510kdatabase.net/k852660/ 1985-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k852660-etch-and-bond-fda-510k.jpg K852660 - ETCH AND BOND K852660 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jul 1985. https://www.510kdatabase.net/k853034/ 1985-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k853034-335-01-silic-rub-isola-sleeve-for-int-fda-510k.jpg K853034 - #335-01 SILIC RUB ISOLA SLEEVE FOR INT #281-03 SIZ K853034 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Jul 1985. https://www.510kdatabase.net/k844810/ 1985-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k844810-new-bard-infection-control-urinary-fda-510k.jpg K844810 - NEW BARD INFECTION CONTROL URINARY DRAINAGE BAG K844810 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jul 1985. https://www.510kdatabase.net/k852414/ 1985-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k852414-lyphochek-drug-free-serumhuman-fda-510k.jpg K852414 - LYPHOCHEK DRUG FREE SERUM(HUMAN) K852414 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bio-Rad. Cleared Jul 1985. https://www.510kdatabase.net/k852658/ 1985-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k852658-eten-gel-fda-510k.jpg K852658 - ETEN-GEL K852658 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jul 1985. https://www.510kdatabase.net/k851669/ 1985-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k851669-monitor-iv-plus-fda-510k.jpg K851669 - MONITOR IV PLUS K851669 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Jul 1985. https://www.510kdatabase.net/k852211/ 1985-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k852211-opsite-wound-dressing-fda-510k.jpg K852211 - OPSITE WOUND DRESSING K852211 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 1985. https://www.510kdatabase.net/k852539/ 1985-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k852539-suszoi-ultrasonic-surgical-aspirator-fda-510k.jpg K852539 - SUSZOI ULTRASONIC SURGICAL ASPIRATOR SONOP K852539 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jul 1985. https://www.510kdatabase.net/k852544/ 1985-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k852544-monoject-sterile-3cc-syringes-w-wo-fda-510k.jpg K852544 - MONOJECT STERILE 3CC SYRINGES W/ & WO/ NEEDLES K852544 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Jul 1985. https://www.510kdatabase.net/k852580/ 1985-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k852580-monoject-sterile-60cc-syringes-fda-510k.jpg K852580 - MONOJECT STERILE 60CC SYRINGES K852580 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Jul 1985. https://www.510kdatabase.net/k852588/ 1985-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k852588-monoject-sterile-6cc-syringe-w-wo-fda-510k.jpg K852588 - MONOJECT STERILE 6CC SYRINGE W/ & WO/ NEEDLES K852588 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Jul 1985. https://www.510kdatabase.net/k852607/ 1985-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k852607-monject-sterile-20cc-syringes-fda-510k.jpg K852607 - MONJECT STERILE 20CC SYRINGES K852607 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Jul 1985. https://www.510kdatabase.net/k852640/ 1985-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k852640-monoject-sterile-35cc-syringes-fda-510k.jpg K852640 - MONOJECT STERILE 35CC SYRINGES K852640 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Jul 1985. https://www.510kdatabase.net/k852787/ 1985-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k852787-technicon-h1-system-fda-510k.jpg K852787 - TECHNICON H*1 SYSTEM K852787 is a FDA 510(k) cleared hematology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Jul 1985. https://www.510kdatabase.net/k852886/ 1985-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k852886-mug-disk-fda-510k.jpg K852886 - MUG DISK K852886 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Jul 1985. https://www.510kdatabase.net/k852556/ 1985-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k852556-tdx-rea-triglycerides-fda-510k.jpg K852556 - TDX REA TRIGLYCERIDES K852556 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jul 1985. https://www.510kdatabase.net/k852671/ 1985-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k852671-aca-tobramy-cin-analytical-test-pack-fda-510k.jpg K852671 - ACA TOBRAMY-CIN ANALYTICAL TEST PACK K852671 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Jul 1985. https://www.510kdatabase.net/k851565/ 1985-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k851565-homedica-cemented-acetabular-component-fda-510k.jpg K851565 - HOMEDICA CEMENTED ACETABULAR COMPONENT 6262 K851565 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Howmedica Corp.. Cleared Jul 1985. https://www.510kdatabase.net/k852431/ 1985-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k852431-suprima-ii-model-254-26-fda-510k.jpg K852431 - SUPRIMA II MODEL 254-26 K852431 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Jul 1985. https://www.510kdatabase.net/k852430/ 1985-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k852430-suprima-ii-model-253-23-fda-510k.jpg K852430 - SUPRIMA II MODEL 253-23 K852430 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Jul 1985. https://www.510kdatabase.net/k852432/ 1985-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k852432-suprima-ii-model-254-28-fda-510k.jpg K852432 - SUPRIMA II MODEL 254-28 K852432 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Jul 1985. https://www.510kdatabase.net/k850077/ 1985-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k850077-medtronic-5311-pacing-system-analyzer-fda-510k.jpg K850077 - MEDTRONIC 5311 PACING SYSTEM ANALYZER K850077 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jul 1985. https://www.510kdatabase.net/k851103/ 1985-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k851103-vascular-implant-access-needle-set-fda-510k.jpg K851103 - VASCULAR IMPLANT ACCESS NEEDLE SET K851103 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jul 1985. https://www.510kdatabase.net/k852059/ 1985-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k852059-the-pca-dome-patella-component-fda-510k.jpg K852059 - THE P.C.A. DOME PATELLA COMPONENT K852059 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jul 1985. https://www.510kdatabase.net/k851341/ 1985-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k851341-synatomic-variable-fit-tibial-plateau-fda-510k.jpg K851341 - SYNATOMIC VARIABLE FIT TIBIAL PLATEAU K851341 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jul 1985. https://www.510kdatabase.net/k852482/ 1985-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k852482-microspin-minicentrifuge-item-no-6520494-fda-510k.jpg K852482 - MICROSPIN MINICENTRIFUGE ITEM NO. 65204/94 K852482 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jul 1985. https://www.510kdatabase.net/k852589/ 1985-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k852589-tdx-immunoglobulin-g-diagnostic-kit-fda-510k.jpg K852589 - TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT K852589 is a FDA 510(k) cleared immunology medical device. Manufacturer: Abbott Laboratories. Cleared Jul 1985. https://www.510kdatabase.net/k851393/ 1985-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k851393-dupont-prep-four-solvent-retrofit-kit-fda-510k.jpg K851393 - DUPONT PREP FOUR-SOLVENT RETROFIT KIT K851393 is a FDA 510(k) cleared pathology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Jul 1985. https://www.510kdatabase.net/k851637/ 1985-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k851637-sirecust-425-respectively-sirecust-430-fda-510k.jpg K851637 - SIRECUST 425, RESPECTIVELY SIRECUST 430 K851637 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 1985. https://www.510kdatabase.net/k852473/ 1985-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k852473-ion-specific-electrode-option-for-fda-510k.jpg K852473 - ION-SPECIFIC ELECTRODE OPTION FOR COBAS FARA K852473 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jul 1985. https://www.510kdatabase.net/k852483/ 1985-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k852483-systemate-ck-mbnac-activated-item-no-fda-510k.jpg K852483 - SYSTEMATE CK-MB(NAC-ACTIVATED) ITEM NO. 67205 K852483 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jul 1985. https://www.510kdatabase.net/k852565/ 1985-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k852565-technicon-chemi-fda-510k.jpg K852565 - TECHNICON CHEMI K852565 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Jul 1985. https://www.510kdatabase.net/k852568/ 1985-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k852568-mcdb-201-med-cat-no-m6770-w-hepes-w0-fda-510k.jpg K852568 - MCDB 201 MED CAT NO. M6770 W/ HEPES & W0/ BICARBON K852568 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Jul 1985. https://www.510kdatabase.net/k852573/ 1985-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k852573-technicon-ra-1000-system-analyte-fda-510k.jpg K852573 - TECHNICON RA-1000 SYSTEM ANALYTE THEOPHYLLINE K852573 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Jul 1985. https://www.510kdatabase.net/k851457/ 1985-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k851457-model-483-06-polyflex-implantable-fda-510k.jpg K851457 - MODEL 483-06 POLYFLEX IMPLANTABLE PACING LEAD K851457 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Jul 1985. https://www.510kdatabase.net/k851458/ 1985-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k851458-model-493-04-polyflex-r-implantable-fda-510k.jpg K851458 - MODEL 493-04 POLYFLEX R IMPLANTABLE PACING LEAD K851458 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Jul 1985. https://www.510kdatabase.net/k852236/ 1985-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k852236-medtronic-model-5867-1a-fda-510k.jpg K852236 - MEDTRONIC MODEL 5867-1A K852236 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jul 1985. https://www.510kdatabase.net/k852247/ 1985-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k852247-laser-ceruloplasmin-kitceruloplasmin-fda-510k.jpg K852247 - LASER CERULOPLASMIN KIT(CERULOPLASMIN REAGENTS) K852247 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Jul 1985. https://www.510kdatabase.net/k850567/ 1985-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k850567-abbott-toxo-m-eia-diagnostic-kit-fda-510k.jpg K850567 - ABBOTT TOXO-M EIA DIAGNOSTIC KIT K850567 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Jul 1985. https://www.510kdatabase.net/k852183/ 1985-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k852183-beta-hcg-extended-range-accessory-kit-fda-510k.jpg K852183 - BETA HCG EXTENDED RANGE ACCESSORY KIT K852183 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jul 1985. https://www.510kdatabase.net/k852285/ 1985-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k852285-dade-blood-gas-ampul-injector-fda-510k.jpg K852285 - DADE BLOOD GAS AMPUL INJECTOR K852285 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Jul 1985. https://www.510kdatabase.net/k852299/ 1985-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k852299-terumo-sensibead-eia-hgh-kit-fda-510k.jpg K852299 - TERUMO SENSIBEAD EIA HGH KIT K852299 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Terumo Medical Corp.. Cleared Jul 1985. https://www.510kdatabase.net/k852320/ 1985-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k852320-cobas-fp-reagen-for-procainamide-pro-fda-510k.jpg K852320 - COBAS FP REAGEN FOR PROCAINAMIDE & PRO CALIBRATOR K852320 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jul 1985. https://www.510kdatabase.net/k852567/ 1985-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k852567-3m-fukuda-type-ring-retractor-fda-510k.jpg K852567 - 3M FUKUDA TYPE RING RETRACTOR K852567 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3M Company. Cleared Jul 1985. https://www.510kdatabase.net/k850889/ 1985-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k850889-bard-occlusive-wound-dressing-fda-510k.jpg K850889 - BARD OCCLUSIVE WOUND DRESSING K850889 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jul 1985. https://www.510kdatabase.net/k852076/ 1985-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k852076-model-145-fetal-monitor-fda-510k.jpg K852076 - MODEL 145 FETAL MONITOR K852076 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Jul 1985. https://www.510kdatabase.net/k852136/ 1985-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k852136-precinorm-hb-fda-510k.jpg K852136 - PRECINORM HB K852136 is a FDA 510(k) cleared hematology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jul 1985. https://www.510kdatabase.net/k852358/ 1985-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k852358-syringe-infusion-pump-as-20-series-fda-510k.jpg K852358 - SYRINGE INFUSION PUMP - AS 20 SERIES K852358 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jul 1985. https://www.510kdatabase.net/k850329/ 1985-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k850329-cordia-s4-treponema-pallidum-fda-510k.jpg K850329 - CORDIA S4 -TREPONEMA PALLIDUM K850329 is a FDA 510(k) cleared immunology medical device. Manufacturer: Cordis Corp.. Cleared Jul 1985. https://www.510kdatabase.net/k851251/ 1985-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k851251-automanual-titanium-hemoclip-ligating-fda-510k.jpg K851251 - AUTO/MANUAL TITANIUM HEMOCLIP LIGATING CLIP 527200 K851251 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Jul 1985. https://www.510kdatabase.net/k851046/ 1985-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k851046-myocare-plus-dual-channel-stimulator-fda-510k.jpg K851046 - MYOCARE PLUS DUAL CHANNEL STIMULATOR K851046 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: 3M Company. Cleared Jul 1985. https://www.510kdatabase.net/k852151/ 1985-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k852151-photo-curing-light-fda-510k.jpg K852151 - PHOTO CURING LIGHT K852151 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jul 1985. https://www.510kdatabase.net/k852344/ 1985-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k852344-distalite-posteria-dental-restorative-fda-510k.jpg K852344 - DISTALITE POSTERIA DENTAL RESTORATIVE K852344 is a FDA 510(k) cleared dental medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jul 1985. https://www.510kdatabase.net/k844142/ 1985-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k844142-gore-tex-tissue-matrix-fda-510k.jpg K844142 - GORE-TEX TISSUE MATRIX K844142 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Jun 1985. https://www.510kdatabase.net/k844947/ 1985-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k844947-emit-ancillary-reagents-fda-510k.jpg K844947 - EMIT ANCILLARY REAGENTS K844947 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jun 1985. https://www.510kdatabase.net/k844950/ 1985-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k844950-emit-amitriptyline-assay-fda-510k.jpg K844950 - EMIT AMITRIPTYLINE ASSAY K844950 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jun 1985. https://www.510kdatabase.net/k844951/ 1985-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k844951-emit-imipramine-assay-fda-510k.jpg K844951 - EMIT IMIPRAMINE ASSAY K844951 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jun 1985. https://www.510kdatabase.net/k844952/ 1985-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k844952-emit-nortriptyline-assay-fda-510k.jpg K844952 - EMIT NORTRIPTYLINE ASSAY K844952 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jun 1985. https://www.510kdatabase.net/k844953/ 1985-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k844953-emit-desipramine-assay-fda-510k.jpg K844953 - EMIT DESIPRAMINE ASSAY K844953 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jun 1985. https://www.510kdatabase.net/k852201/ 1985-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k852201-echoclonal-hcg-irma-fda-510k.jpg K852201 - ECHOCLONAL HCG IRMA K852201 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Jun 1985. https://www.510kdatabase.net/k852087/ 1985-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k852087-capiox-luer-design-thermistors-capiox-fda-510k.jpg K852087 - CAPIOX LUER DESIGN THERMISTORS & CAPIOX CONNECTORS K852087 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terumo Medical Corp.. Cleared Jun 1985. https://www.510kdatabase.net/k844252/ 1985-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k844252-model-9300-trend-analyzing-bio-monitor-fda-510k.jpg K844252 - MODEL 9300 TREND ANALYZING BIO-MONITOR SYS K844252 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jun 1985. https://www.510kdatabase.net/k851400/ 1985-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k851400-sirecust-420-patient-dialog-monitor-fda-510k.jpg K851400 - SIRECUST 420 PATIENT DIALOG MONITOR K851400 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jun 1985. https://www.510kdatabase.net/k852066/ 1985-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k852066-pregnancy-card-test-fda-510k.jpg K852066 - PREGNANCY CARD TEST K852066 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jun 1985. https://www.510kdatabase.net/k852317/ 1985-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k852317-cobas-fp-reagen-for-amikacin-amikacin-fda-510k.jpg K852317 - COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR K852317 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jun 1985. https://www.510kdatabase.net/k852318/ 1985-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k852318-cobas-fp-reagen-for-primidone-primi-fda-510k.jpg K852318 - COBAS FP REAGEN FOR PRIMIDONE & PRIMI CALIBRATORS K852318 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jun 1985. https://www.510kdatabase.net/k852319/ 1985-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k852319-cobas-fp-reagents-for-napa-and-napa-fda-510k.jpg K852319 - COBAS FP REAGENTS FOR NAPA AND NAPA CALIBRATORS K852319 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jun 1985. https://www.510kdatabase.net/k850504/ 1985-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k850504-corometrics-500-infant-monitor-fda-510k.jpg K850504 - COROMETRICS 500 INFANT MONITOR K850504 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Jun 1985. https://www.510kdatabase.net/k844068/ 1985-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k844068-trochanter-cable-grip-system-fda-510k.jpg K844068 - TROCHANTER CABLE GRIP SYSTEM K844068 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jun 1985. https://www.510kdatabase.net/k851420/ 1985-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k851420-multicor-s-models-330a331a-fda-510k.jpg K851420 - MULTICOR S, MODELS 330A/331A K851420 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Jun 1985. https://www.510kdatabase.net/k851622/ 1985-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k851622-timentin-85-mcg-sensi-disc-fda-510k.jpg K851622 - TIMENTIN 85 MCG. SENSI-DISC K851622 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jun 1985. https://www.510kdatabase.net/k851912/ 1985-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k851912-laser-prealbumin-test-fda-510k.jpg K851912 - LASER PREALBUMIN TEST K851912 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Jun 1985. https://www.510kdatabase.net/k851940/ 1985-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k851940-sterile-water-for-inhalation-usp-2d0799-fda-510k.jpg K851940 - STERILE WATER FOR INHALATION USP 2D0799 K851940 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Jun 1985. https://www.510kdatabase.net/k851948/ 1985-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k851948-medtronic-model-6404-fda-510k.jpg K851948 - MEDTRONIC MODEL 6404 K851948 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jun 1985. https://www.510kdatabase.net/k851890/ 1985-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k851890-medtronic-5064-fda-510k.jpg K851890 - MEDTRONIC 5064 K851890 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jun 1985. https://www.510kdatabase.net/k844360/ 1985-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k844360-cordis-multicor-s-330a-331a-cardiac-fda-510k.jpg K844360 - CORDIS MULTICOR S 330A & 331A CARDIAC PACEMAKERS K844360 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Jun 1985. https://www.510kdatabase.net/k851074/ 1985-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k851074-variable-nebulizer-heater-fda-510k.jpg K851074 - VARIABLE NEBULIZER HEATER K851074 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Jun 1985. https://www.510kdatabase.net/k851404/ 1985-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k851404-omnifit-threaded-acetabular-components-fda-510k.jpg K851404 - OMNIFIT THREADED ACETABULAR COMPONENTS 2005 SERIES K851404 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Jun 1985. https://www.510kdatabase.net/k851300/ 1985-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k851300-neuropack-8-mee-4108-fda-510k.jpg K851300 - NEUROPACK 8, MEE-4108 K851300 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Jun 1985. https://www.510kdatabase.net/k851881/ 1985-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k851881-orthopeadic-cement-delivery-system-fda-510k.jpg K851881 - ORTHOPEADIC CEMENT DELIVERY SYSTEM K851881 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Dentsply Intl.. Cleared Jun 1985. https://www.510kdatabase.net/k852070/ 1985-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k852070-shiley-silicone-sual-lumen-subclavian-fda-510k.jpg K852070 - SHILEY SILICONE SUAL LUMEN SUBCLAVIAN CANNUAL K852070 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Shiley, Inc.. Cleared Jun 1985. https://www.510kdatabase.net/k852297/ 1985-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k852297-johnson-johnson-ostomy-size-selector-fda-510k.jpg K852297 - JOHNSON & JOHNSON OSTOMY SIZE SELECTOR & BELT K852297 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jun 1985. https://www.510kdatabase.net/k843273/ 1985-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k843273-dispos-pressure-kit-1295k-series-fda-510k.jpg K843273 - DISPOS. PRESSURE KIT 1295K SERIES K843273 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Jun 1985. https://www.510kdatabase.net/k844815/ 1985-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k844815-cordis-electrophysiology-stimulator-fda-510k.jpg K844815 - CORDIS ELECTROPHYSIOLOGY STIMULATOR K844815 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Jun 1985. https://www.510kdatabase.net/k851416/ 1985-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k851416-stanicor-gamma-333b334a-fda-510k.jpg K851416 - STANICOR GAMMA 333B/334A K851416 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Jun 1985. https://www.510kdatabase.net/k851417/ 1985-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k851417-multicor-gamma-models-336337-fda-510k.jpg K851417 - MULTICOR GAMMA MODELS 336/337 K851417 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Jun 1985. https://www.510kdatabase.net/k851418/ 1985-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k851418-omni-atricor-model-308a-fda-510k.jpg K851418 - OMNI-ATRICOR MODEL 308A K851418 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Jun 1985. https://www.510kdatabase.net/k851419/ 1985-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k851419-multicor-gamma-402-series-pacer-fda-510k.jpg K851419 - MULTICOR GAMMA 402 SERIES PACER K851419 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Jun 1985. https://www.510kdatabase.net/k852117/ 1985-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k852117-cyto-tek-centrifuge-fda-510k.jpg K852117 - CYTO-TEK CENTRIFUGE K852117 is a FDA 510(k) cleared pathology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Jun 1985. https://www.510kdatabase.net/k852130/ 1985-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k852130-glucosetrinder-reagent-fda-510k.jpg K852130 - GLUCOSE(TRINDER) REAGENT K852130 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Jun 1985. https://www.510kdatabase.net/k852131/ 1985-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k852131-bunendpoint-reagent-fda-510k.jpg K852131 - BUN(ENDPOINT) REAGENT K852131 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Jun 1985. https://www.510kdatabase.net/k851258/ 1985-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k851258-weck-lx-tm-skin-stapler-fda-510k.jpg K851258 - WECK LX TM SKIN STAPLER K851258 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Jun 1985. https://www.510kdatabase.net/k851935/ 1985-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k851935-edwards-sacral-screw-fda-510k.jpg K851935 - EDWARDS SACRAL SCREW K851935 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jun 1985. https://www.510kdatabase.net/k842817/ 1985-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k842817-model-78353b-fda-510k.jpg K842817 - MODEL 78353B K842817 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Jun 1985. https://www.510kdatabase.net/k850885/ 1985-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k850885-starcam-data-acquisition-processing-fda-510k.jpg K850885 - STARCAM DATA ACQUISITION & PROCESSING SYS H3300C K850885 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jun 1985. https://www.510kdatabase.net/k851741/ 1985-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k851741-acculevel-theophylline-testmodification-fda-510k.jpg K851741 - ACCULEVEL THEOPHYLLINE TEST(MODIFICATION) K851741 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jun 1985. https://www.510kdatabase.net/k850451/ 1985-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k850451-j-j-ulcer-dressing-fda-510k.jpg K850451 - J & J ULCER DRESSING K850451 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jun 1985. https://www.510kdatabase.net/k851537/ 1985-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k851537-laser-rf-control-serum-quality-control-fda-510k.jpg K851537 - LASER RF CONTROL SERUM-QUALITY CONTROL SERUM K851537 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Jun 1985. https://www.510kdatabase.net/k851063/ 1985-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k851063-tensmed-ii-fda-510k.jpg K851063 - TENSMED II K851063 is a FDA 510(k) cleared neurology medical device. Manufacturer: Intermedics, Inc.. Cleared Jun 1985. https://www.510kdatabase.net/k851084/ 1985-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k851084-economy-400-cws-with-pvc-drains-fda-510k.jpg K851084 - ECONOMY 400 CWS WITH PVC DRAINS K851084 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jun 1985. https://www.510kdatabase.net/k851564/ 1985-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k851564-model-2000-indulin-infusion-pump-fda-510k.jpg K851564 - MODEL 2000 INDULIN INFUSION PUMP K851564 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared May 1985. https://www.510kdatabase.net/k851125/ 1985-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k851125-aca-prothrombin-time-analytical-test-fda-510k.jpg K851125 - ACA PROTHROMBIN TIME ANALYTICAL TEST PACK K851125 is a FDA 510(k) cleared hematology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared May 1985. https://www.510kdatabase.net/k851126/ 1985-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k851126-aca-activated-partial-thromboplastin-fda-510k.jpg K851126 - ACA ACTIVATED PARTIAL THROMBOPLASTIN TIME ANALYTIC K851126 is a FDA 510(k) cleared hematology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared May 1985. https://www.510kdatabase.net/k851127/ 1985-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k851127-dupont-aca-prothrombin-timeactivated-fda-510k.jpg K851127 - DUPONT ACA PROTHROMBIN TIME/ACTIVATED PARTIAL THRO K851127 is a FDA 510(k) cleared hematology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared May 1985. https://www.510kdatabase.net/k851930/ 1985-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k851930-tdx-rea-irontibc-fda-510k.jpg K851930 - TDX REA IRON/TIBC K851930 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared May 1985. https://www.510kdatabase.net/k850978/ 1985-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k850978-olympus-lf-1-intubation-scope-fda-510k.jpg K850978 - OLYMPUS LF-1 INTUBATION SCOPE K850978 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Olympus Corp.. Cleared May 1985. https://www.510kdatabase.net/k851303/ 1985-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k851303-comfort-ease-electrode-fda-510k.jpg K851303 - COMFORT-EASE ELECTRODE K851303 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared May 1985. https://www.510kdatabase.net/k851398/ 1985-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k851398-bard-peristomal-paste-fda-510k.jpg K851398 - BARD PERISTOMAL PASTE K851398 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 1985. https://www.510kdatabase.net/k851096/ 1985-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k851096-hpu-heat-probe-automated-fda-510k.jpg K851096 - HPU HEAT PROBE AUTOMATED ELECTROCAUTERY SYSTEM K851096 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Corp.. Cleared May 1985. https://www.510kdatabase.net/k851229/ 1985-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k851229-codman-arthroscope-fda-510k.jpg K851229 - CODMAN ARTHROSCOPE K851229 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared May 1985. https://www.510kdatabase.net/k851252/ 1985-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k851252-corometrics-115-fetal-monitor-wdual-fda-510k.jpg K851252 - COROMETRICS 115 FETAL MONITOR W/DUAL CARDIOTACHOME K851252 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared May 1985. https://www.510kdatabase.net/k850917/ 1985-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k850917-argyle-griffith-tdmac-heparinized-veno-fda-510k.jpg K850917 - ARGYLE GRIFFITH TDMAC HEPARINIZED VENO-VENOUS SHUN K850917 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sherwood Medical Co.. Cleared May 1985. https://www.510kdatabase.net/k851086/ 1985-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k851086-vicryl-polyglactin-910mersilene-fda-510k.jpg K851086 - VICRYL (POLYGLACTIN 910/MERSILENE COMPOISITE MESH K851086 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared May 1985. https://www.510kdatabase.net/k851459/ 1985-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k851459-visilux-2-visible-light-curing-unit-fda-510k.jpg K851459 - VISILUX 2 VISIBLE LIGHT CURING UNIT K851459 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared May 1985. https://www.510kdatabase.net/k843622/ 1985-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k843622-abbott-hsv-eia-fda-510k.jpg K843622 - ABBOTT HSV EIA K843622 is a FDA 510(k) cleared immunology medical device. Manufacturer: Abbott Laboratories. Cleared May 1985. https://www.510kdatabase.net/k845021/ 1985-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k845021-medical-dynamics-mcconnell-precision-fda-510k.jpg K845021 - MEDICAL DYNAMICS MCCONNELL PRECISION ELEC-INSUFFLA K845021 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Medline Industries, Inc.. Cleared May 1985. https://www.510kdatabase.net/k850768/ 1985-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k850768-toxoscan-card-test-kit-fda-510k.jpg K850768 - TOXOSCAN CARD TEST KIT K850768 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared May 1985. https://www.510kdatabase.net/k851676/ 1985-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k851676-tdx-total-t3-fda-510k.jpg K851676 - TDX TOTAL T3 K851676 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared May 1985. https://www.510kdatabase.net/k844193/ 1985-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k844193-quinton-injection-sealing-cap-fda-510k.jpg K844193 - QUINTON INJECTION SEALING CAP K844193 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Quinton, Inc.. Cleared May 1985. https://www.510kdatabase.net/k850638/ 1985-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k850638-laser-apo-a-i-test-apolipoprotein-a-i-fda-510k.jpg K850638 - LASER APO A-I TEST APOLIPOPROTEIN A-I REAGENTS K850638 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared May 1985. https://www.510kdatabase.net/k851302/ 1985-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k851302-quinton-q-tel-418t-419t-remote-cardiac-fda-510k.jpg K851302 - QUINTON Q-TEL 418T & 419T REMOTE CARDIAC MONITOR K851302 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared May 1985. https://www.510kdatabase.net/k851396/ 1985-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k851396-sanders-maskcpap-by-respironics-fda-510k.jpg K851396 - SANDER'S MASKCPAP BY RESPIRONICS K851396 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared May 1985. https://www.510kdatabase.net/k851604/ 1985-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k851604-crcm-30-medium-product-no-c5030-fda-510k.jpg K851604 - CRCM-30 MEDIUM PRODUCT NO. C5030 K851604 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared May 1985. https://www.510kdatabase.net/k851605/ 1985-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k851605-swins-s-77-medium-products-s2513-fda-510k.jpg K851605 - SWIN'S S-77 MEDIUM, PRODUCTS S2513 K851605 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared May 1985. https://www.510kdatabase.net/k851606/ 1985-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k851606-d-pbs-products-no-d5652-fda-510k.jpg K851606 - D-PBS, PRODUCTS NO. D5652 K851606 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared May 1985. https://www.510kdatabase.net/k851607/ 1985-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k851607-mcdb-151-medium-product-no-m6645-fda-510k.jpg K851607 - MCDB 151 MEDIUM, PRODUCT NO. M6645 K851607 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared May 1985. https://www.510kdatabase.net/k851608/ 1985-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k851608-sfre199-1-medium-product-no-s-2013-fda-510k.jpg K851608 - SFRE199-1 MEDIUM PRODUCT NO. S 2013 K851608 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared May 1985. https://www.510kdatabase.net/k851609/ 1985-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k851609-sfre-199-2-medium-products-no-s2138-fda-510k.jpg K851609 - SFRE 199-2 MEDIUM, PRODUCTS NO. S2138 K851609 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared May 1985. https://www.510kdatabase.net/k850415/ 1985-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k850415-cronex-kevlar-cassette-fda-510k.jpg K850415 - CRONEX KEVLAR CASSETTE K850415 is a FDA 510(k) cleared radiology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared May 1985. https://www.510kdatabase.net/k850291/ 1985-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k850291-mueller-hinton-agar-w4-nacl-wantibiotics-fda-510k.jpg K850291 - MUELLER HINTON AGAR W/4% NACL W/ANTIBIOTICS K850291 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared May 1985. https://www.510kdatabase.net/k850859/ 1985-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k850859-cobas-calibrator-serum-fda-510k.jpg K850859 - COBAS CALIBRATOR SERUM K850859 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared May 1985. https://www.510kdatabase.net/k851568/ 1985-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k851568-emit-700-benzodiazepine-assay-fda-510k.jpg K851568 - EMIT 700 BENZODIAZEPINE ASSAY K851568 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared May 1985. https://www.510kdatabase.net/k851904/ 1985-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k851904-data-trac-anesthesiology-recorder-fda-510k.jpg K851904 - DATA TRAC ANESTHESIOLOGY RECORDER K851904 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Datascope Corp.. Cleared May 1985. https://www.510kdatabase.net/k850282/ 1985-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k850282-hypafix-post-operative-dressing-fda-510k.jpg K850282 - HYPAFIX POST OPERATIVE DRESSING K850282 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared May 1985. https://www.510kdatabase.net/k851487/ 1985-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k851487-codman-disposable-bipolar-card-fda-510k.jpg K851487 - CODMAN DISPOSABLE BIPOLAR CARD K851487 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared May 1985. https://www.510kdatabase.net/k845022/ 1985-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k845022-patho-dx-latex-agglutination-strep-b-kit-fda-510k.jpg K845022 - PATHO DX LATEX AGGLUTINATION STREP B KIT K845022 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Diagnostic Products Corp.. Cleared May 1985. https://www.510kdatabase.net/k851172/ 1985-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k851172-cobas-mira-fda-510k.jpg K851172 - COBAS MIRA K851172 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared May 1985. https://www.510kdatabase.net/k844969/ 1985-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k844969-cordis-dual-chamber-psa-model-296a-fda-510k.jpg K844969 - CORDIS DUAL-CHAMBER PSA MODEL 296A (PACEMAKER) K844969 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared May 1985. https://www.510kdatabase.net/k850766/ 1985-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k850766-zimmer-threaded-acetabular-cup-fda-510k.jpg K850766 - ZIMMER THREADED ACETABULAR CUP K850766 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared May 1985. https://www.510kdatabase.net/k851373/ 1985-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k851373-emit-700-cannabinoid-20-assay-fda-510k.jpg K851373 - EMIT 700 CANNABINOID 20 ASSAY K851373 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared May 1985. https://www.510kdatabase.net/k851253/ 1985-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k851253-tdx-analyzer-wnephelometry-carousel-fda-510k.jpg K851253 - TDX ANALYZER W/NEPHELOMETRY CAROUSEL K851253 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1985. https://www.510kdatabase.net/k851234/ 1985-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k851234-a-just-turbidity-meter-fda-510k.jpg K851234 - A-JUST TURBIDITY METER K851234 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1985. https://www.510kdatabase.net/k850352/ 1985-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k850352-micro-struc-acetabular-compon-mc2p-fda-510k.jpg K850352 - MICRO-STRUC. ACETABULAR COMPON- MC2P K850352 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Apr 1985. https://www.510kdatabase.net/k850637/ 1985-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k850637-exothermic-heating-pad-fda-510k.jpg K850637 - EXOTHERMIC HEATING PAD K850637 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Apr 1985. https://www.510kdatabase.net/k851098/ 1985-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k851098-behring-vector-photometer-fda-510k.jpg K851098 - BEHRING VECTOR PHOTOMETER K851098 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Apr 1985. https://www.510kdatabase.net/k843751/ 1985-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k843751-cordia-hs-antibody-typing-reagents-fda-510k.jpg K843751 - CORDIA HS ANTIBODY TYPING REAGENTS K843751 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Cordis Corp.. Cleared Apr 1985. https://www.510kdatabase.net/k850055/ 1985-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k850055-profile-femoral-hip-fda-510k.jpg K850055 - PROFILE FEMORAL HIP K850055 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Apr 1985. https://www.510kdatabase.net/k850194/ 1985-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k850194-caffeic-acid-disk-fda-510k.jpg K850194 - CAFFEIC ACID DISK K850194 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Apr 1985. https://www.510kdatabase.net/k851056/ 1985-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k851056-opaquerbonding-agent-fda-510k.jpg K851056 - OPAQUER/BONDING AGENT K851056 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Apr 1985. https://www.510kdatabase.net/k851249/ 1985-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k851249-septi-chek-schaedler-med-blood-culture-fda-510k.jpg K851249 - SEPTI-CHEK SCHAEDLER MED. BLOOD CULTURE BOTTLE-ROC K851249 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Apr 1985. https://www.510kdatabase.net/k851250/ 1985-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k851250-septi-chek-tsb-wsucrose-blood-culture-fda-510k.jpg K851250 - SEPTI-CHEK TSB W/SUCROSE BLOOD CULTURE BOTTLE-ROCH K851250 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Apr 1985. https://www.510kdatabase.net/k845025/ 1985-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k845025-austin-moore-modular-hip-prosthesis-fda-510k.jpg K845025 - AUSTIN-MOORE MODULAR HIP PROSTHESIS K845025 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Apr 1985. https://www.510kdatabase.net/k850343/ 1985-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k850343-display-monitor-vd-711ra-vd-712ra-fda-510k.jpg K850343 - DISPLAY MONITOR (VD-711RA-VD-712RA) K850343 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Apr 1985. https://www.510kdatabase.net/k850273/ 1985-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k850273-ethicon-cholangioclip-fda-510k.jpg K850273 - ETHICON - CHOLANGIOCLIP K850273 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Apr 1985. https://www.510kdatabase.net/k851308/ 1985-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k851308-analytes-albumin-total-bilirubin-ast-fda-510k.jpg K851308 - ANALYTES ALBUMIN, TOTAL BILIRUBIN, AST, ALT GEN2 S K851308 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Apr 1985. https://www.510kdatabase.net/k850911/ 1985-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k850911-triad-c-b-material-fda-510k.jpg K850911 - TRIAD C & B MATERIAL K850911 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Apr 1985. https://www.510kdatabase.net/k851091/ 1985-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k851091-medtronic-model-5328-program-stimulator-fda-510k.jpg K851091 - MEDTRONIC MODEL 5328 PROGRAM-STIMULATOR K851091 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Apr 1985. https://www.510kdatabase.net/k850296/ 1985-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k850296-laser-rf-test-rheumatoid-factors-fda-510k.jpg K850296 - LASER RF TEST -RHEUMATOID FACTOR(S) REAGENTS K850296 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Apr 1985. https://www.510kdatabase.net/k850574/ 1985-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k850574-dade-immu-trace-tri-rac-r-tri-level-fda-510k.jpg K850574 - DADE IMMU-TRACE TRI-RAC R TRI-LEVEL IMMUNOASSAY CO K850574 is a FDA 510(k) cleared immunology medical device. Manufacturer: American Dade. Cleared Apr 1985. https://www.510kdatabase.net/k851061/ 1985-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k851061-emit-qst-procainamide-assay-fda-510k.jpg K851061 - EMIT QST PROCAINAMIDE ASSAY K851061 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Apr 1985. https://www.510kdatabase.net/k851089/ 1985-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k851089-monoject-sterile-12cc-syringes-wwo-fda-510k.jpg K851089 - MONOJECT STERILE 12CC SYRINGES, W/WO NEEDLES K851089 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Apr 1985. https://www.510kdatabase.net/k851090/ 1985-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k851090-monoject-sterile-12-cc-1cc-syringes-w-fda-510k.jpg K851090 - MONOJECT STERILE 1/2 CC & 1CC SYRINGES W & W/O NEE K851090 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Apr 1985. https://www.510kdatabase.net/k844187/ 1985-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k844187-siemens-sirecust-404n-neonatal-monitor-fda-510k.jpg K844187 - SIEMENS SIRECUST 404N NEONATAL MONITOR K844187 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 1985. https://www.510kdatabase.net/k843058/ 1985-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k843058-q-dop-fda-510k.jpg K843058 - Q-DOP K843058 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Apr 1985. https://www.510kdatabase.net/k850145/ 1985-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k850145-cardiac-sector-probe-35-mhz-fda-510k.jpg K850145 - CARDIAC SECTOR PROBE 3.5. MHZ K850145 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 1985. https://www.510kdatabase.net/k850216/ 1985-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k850216-cardiac-sector-probe-50-mhz-fda-510k.jpg K850216 - CARDIAC SECTOR PROBE 5.0 MHZ K850216 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Apr 1985. https://www.510kdatabase.net/k850575/ 1985-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k850575-dade-alcohol-ammonia-controls-level-i-fda-510k.jpg K850575 - DADE ALCOHOL & AMMONIA CONTROLS LEVEL I-LOW & II H K850575 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Apr 1985. https://www.510kdatabase.net/k850823/ 1985-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k850823-srx-200-diagnostic-x-ray-high-voltage-fda-510k.jpg K850823 - SRX 200 DIAGNOSTIC X-RAY, HIGH VOLTAGE GENERATOR K850823 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Apr 1985. https://www.510kdatabase.net/k851079/ 1985-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k851079-beckman-triglycerides-control-levels-fda-510k.jpg K851079 - BECKMAN TRIGLYCERIDES CONTROL LEVELS 1/2 &3 K851079 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Apr 1985. https://www.510kdatabase.net/k850568/ 1985-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k850568-model-78231d-cardiac-output-module-fda-510k.jpg K850568 - MODEL 78231D CARDIAC OUTPUT MODULE K850568 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Apr 1985. https://www.510kdatabase.net/k850256/ 1985-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k850256-confirm-immunoassay-for-detecttion-fda-510k.jpg K850256 - CONFIRM IMMUNOASSAY FOR DETECTTION STREP-PYOGENES K850256 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1985. https://www.510kdatabase.net/k850375/ 1985-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k850375-microsurgery-visibility-background-fda-510k.jpg K850375 - MICROSURGERY VISIBILITY BACKGROUND MATERIAL K850375 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Apr 1985. https://www.510kdatabase.net/k850821/ 1985-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k850821-cerestore-dentin-porcelain-fda-510k.jpg K850821 - CERESTORE DENTIN PORCELAIN K850821 is a FDA 510(k) cleared dental medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Apr 1985. https://www.510kdatabase.net/k850831/ 1985-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k850831-strep-a-quick-fda-510k.jpg K850831 - STREP A QUICK K850831 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1985. https://www.510kdatabase.net/k850999/ 1985-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k850999-technicon-gen-2-sys-analytes-ld-alp-ck-fda-510k.jpg K850999 - TECHNICON GEN 2 SYS & ANALYTES LD, ALP CK, UN, IN K850999 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Apr 1985. https://www.510kdatabase.net/k851207/ 1985-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k851207-extended-life-capd-solution-transfer-fda-510k.jpg K851207 - EXTENDED LIFE CAPD SOLUTION TRANSFER SET 5C4153 K851207 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Apr 1985. https://www.510kdatabase.net/k851208/ 1985-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k851208-compact-exchange-device-5c4197-fda-510k.jpg K851208 - COMPACT EXCHANGE DEVICE 5C4197 K851208 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Apr 1985. https://www.510kdatabase.net/k851060/ 1985-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k851060-emit-qst-n-acetylprocainamide-assay-fda-510k.jpg K851060 - EMIT QST N-ACETYLPROCAINAMIDE ASSAY K851060 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Apr 1985. https://www.510kdatabase.net/k850710/ 1985-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k850710-travenol-flo-gard-500-iv-monitor-fda-510k.jpg K850710 - TRAVENOL FLO-GARD 500 IV MONITOR K850710 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Apr 1985. https://www.510kdatabase.net/k802294/ 1985-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k802294-poly-flex-implantable-pacing-lead-fda-510k.jpg K802294 - POLY FLEX IMPLANTABLE PACING LEAD K802294 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Apr 1985. https://www.510kdatabase.net/k813135/ 1985-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k813135-model-486-01-pacemaker-lead-fda-510k.jpg K813135 - MODEL 486-01 PACEMAKER LEAD K813135 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Apr 1985. https://www.510kdatabase.net/k813136/ 1985-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k813136-model-492-01-pacemaker-lead-fda-510k.jpg K813136 - MODEL 492-01 PACEMAKER LEAD K813136 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Apr 1985. https://www.510kdatabase.net/k820267/ 1985-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k820267-intermedics-polyflex-pacing-lead-480-01-fda-510k.jpg K820267 - INTERMEDICS POLYFLEX PACING LEAD #480-01 K820267 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Apr 1985. https://www.510kdatabase.net/k843062/ 1985-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k843062-tbm-reagent-for-tb-cell-monocytes-fda-510k.jpg K843062 - TBM-REAGENT FOR T,B CELL & MONOCYTES K843062 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1985. https://www.510kdatabase.net/k843908/ 1985-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k843908-abbott-tdt-eia-fda-510k.jpg K843908 - ABBOTT TDT EIA K843908 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1985. https://www.510kdatabase.net/k851032/ 1985-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k851032-cobas-fp-reagents-for-digoxin-cobas-fp-fda-510k.jpg K851032 - COBAS FP REAGENTS FOR DIGOXIN & COBAS FP DIGOXIN C K851032 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Apr 1985. https://www.510kdatabase.net/k850570/ 1985-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k850570-stratus-hcg-fluorometric-enzyme-fda-510k.jpg K850570 - STRATUS HCG FLUOROMETRIC ENZYME IMMUNOASSAY K850570 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Apr 1985. https://www.510kdatabase.net/k850920/ 1985-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k850920-emit-dau-propoxyphene-assay-fda-510k.jpg K850920 - EMIT D.A.U. PROPOXYPHENE ASSAY K850920 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Apr 1985. https://www.510kdatabase.net/k844353/ 1985-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k844353-physiological-monitor-2100-fda-510k.jpg K844353 - PHYSIOLOGICAL MONITOR 2100 K844353 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Apr 1985. https://www.510kdatabase.net/k850250/ 1985-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k850250-technicon-testpoint-assayed-hematology-fda-510k.jpg K850250 - TECHNICON TESTPOINT ASSAYED HEMATOLOGY LOW & HIGH K850250 is a FDA 510(k) cleared hematology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Apr 1985. https://www.510kdatabase.net/k850659/ 1985-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k850659-syva-700-system-accessories-clinical-fda-510k.jpg K850659 - SYVA 700 SYSTEM ACCESSORIES-CLINICAL CHEM ANALYZER K850659 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Apr 1985. https://www.510kdatabase.net/k850953/ 1985-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k850953-emit-700-methadone-assay-fda-510k.jpg K850953 - EMIT 700 METHADONE ASSAY K850953 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Apr 1985. https://www.510kdatabase.net/k850054/ 1985-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k850054-rianen-angiotensin-i-radioimmunoassay-ki-fda-510k.jpg K850054 - RIANEN ANGIOTENSIN I RADIOIMMUNOASSAY KI K850054 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Mar 1985. https://www.510kdatabase.net/k850856/ 1985-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k850856-ics-theophylline-reagents-fda-510k.jpg K850856 - ICS THEOPHYLLINE REAGENTS K850856 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Mar 1985. https://www.510kdatabase.net/k844259/ 1985-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k844259-model-486-01-pacing-lead-fda-510k.jpg K844259 - MODEL 486-01 PACING LEAD K844259 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Mar 1985. https://www.510kdatabase.net/k844260/ 1985-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k844260-model-476-03-pacing-lead-fda-510k.jpg K844260 - MODEL 476-03 PACING LEAD K844260 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Mar 1985. https://www.510kdatabase.net/k844261/ 1985-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k844261-model-490-01-pacing-lead-fda-510k.jpg K844261 - MODEL 490-01 PACING LEAD K844261 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Mar 1985. https://www.510kdatabase.net/k844262/ 1985-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k844262-model-483-01-pacing-lead-fda-510k.jpg K844262 - MODEL 483-01 PACING LEAD K844262 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Mar 1985. https://www.510kdatabase.net/k844263/ 1985-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k844263-model-493-01-pacing-lead-fda-510k.jpg K844263 - MODEL 493-01 PACING LEAD K844263 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Mar 1985. https://www.510kdatabase.net/k844264/ 1985-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k844264-model-493-03-pacing-lead-fda-510k.jpg K844264 - MODEL 493-03 PACING LEAD K844264 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Mar 1985. https://www.510kdatabase.net/k844265/ 1985-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k844265-model-495-01-pacing-lead-fda-510k.jpg K844265 - MODEL 495-01 PACING LEAD K844265 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Mar 1985. https://www.510kdatabase.net/k844266/ 1985-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k844266-model-492-01-pacing-lead-fda-510k.jpg K844266 - MODEL 492-01 PACING LEAD K844266 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Mar 1985. https://www.510kdatabase.net/k844267/ 1985-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k844267-model-483-01-pacing-lead-fda-510k.jpg K844267 - MODEL 483-01 PACING LEAD K844267 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Mar 1985. https://www.510kdatabase.net/k844268/ 1985-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k844268-model-483-03-pacing-lead-fda-510k.jpg K844268 - MODEL 483-03 PACING LEAD K844268 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Mar 1985. https://www.510kdatabase.net/k844269/ 1985-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k844269-model-483-02-pacing-lead-fda-510k.jpg K844269 - MODEL 483-02 PACING LEAD K844269 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Mar 1985. https://www.510kdatabase.net/k844270/ 1985-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k844270-model-480-01-pacing-lead-fda-510k.jpg K844270 - MODEL 480-01 PACING LEAD K844270 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Mar 1985. https://www.510kdatabase.net/k844271/ 1985-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k844271-model-479-01-pacing-lead-fda-510k.jpg K844271 - MODEL 479-01 PACING LEAD K844271 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Mar 1985. https://www.510kdatabase.net/k844272/ 1985-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k844272-model-473-03-pacing-lead-fda-510k.jpg K844272 - MODEL 473-03 PACING LEAD K844272 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Mar 1985. https://www.510kdatabase.net/k844970/ 1985-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k844970-cordis-encor-pervenous-atrial-fda-510k.jpg K844970 - CORDIS ENCOR PERVENOUS ATRIAL & VENTRICULAR LEADS K844970 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Mar 1985. https://www.510kdatabase.net/k850061/ 1985-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k850061-micro-volume-double-line-extension-set-fda-510k.jpg K850061 - MICRO VOLUME DOUBLE LINE EXTENSION SET K850061 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Mar 1985. https://www.510kdatabase.net/k850125/ 1985-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k850125-multi-size-cassette-holder-fda-510k.jpg K850125 - MULTI-SIZE CASSETTE HOLDER K850125 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Mar 1985. https://www.510kdatabase.net/k850808/ 1985-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k850808-cobas-fp-reagents-for-quinidine-fda-510k.jpg K850808 - COBAS FP REAGENTS FOR QUINIDINE K850808 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Mar 1985. https://www.510kdatabase.net/k850890/ 1985-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k850890-mccoys-5a-m9270-wl-glutamine-wo-phenol-fda-510k.jpg K850890 - MCCOY'S 5A M9270 W/L-GLUTAMINE & W/O PHENOL RED & K850890 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sigma Chemical Co.. Cleared Mar 1985. https://www.510kdatabase.net/k850891/ 1985-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k850891-dulbeccos-modified-eagles-medium-d7777-fda-510k.jpg K850891 - DULBECCO'S MODIFIED EAGLE'S MEDIUM D7777, W/L-GLUT K850891 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sigma Chemical Co.. Cleared Mar 1985. https://www.510kdatabase.net/k850921/ 1985-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k850921-mem-m7270-webss-l-glutamine-wo-l-fda-510k.jpg K850921 - MEM, M7270, W/EBSS, L-GLUTAMINE & W/O L-LEUCINE - K850921 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sigma Chemical Co.. Cleared Mar 1985. https://www.510kdatabase.net/k850922/ 1985-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k850922-mem-d-val-modif-m7395-webss-l-fda-510k.jpg K850922 - MEM D-VAL MODIF. M7395, W/EBSS, L-GLUTAMINE, D-VAL K850922 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sigma Chemical Co.. Cleared Mar 1985. https://www.510kdatabase.net/k850963/ 1985-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k850963-dupont-prep-type-si-extraciton-cartridge-fda-510k.jpg K850963 - DUPONT PREP TYPE SI EXTRACITON CARTRIDGE K850963 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Mar 1985. https://www.510kdatabase.net/k850807/ 1985-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k850807-cobas-fp-reagents-for-carbamazepine-fda-510k.jpg K850807 - COBAS FP REAGENTS FOR CARBAMAZEPINE K850807 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Mar 1985. https://www.510kdatabase.net/k850625/ 1985-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k850625-argyle-15mm-swivel-connector-fda-510k.jpg K850625 - ARGYLE 15MM SWIVEL CONNECTOR K850625 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sherwood Medical Co.. Cleared Mar 1985. https://www.510kdatabase.net/k850357/ 1985-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k850357-amdinocillin-10-mcg-sensi-disc-fda-510k.jpg K850357 - AMDINOCILLIN 10 MCG SENSI-DISC K850357 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1985. https://www.510kdatabase.net/k850358/ 1985-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k850358-ceftriaxone-30-mcg-sensi-disc-fda-510k.jpg K850358 - CEFTRIAXONE 30 MCG SENSI-DISC K850358 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1985. https://www.510kdatabase.net/k850712/ 1985-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k850712-emit-qst-phenytoin-assay-monoclonal-fda-510k.jpg K850712 - EMIT QST PHENYTOIN ASSAY -MONOCLONAL ANTIBODY K850712 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Mar 1985. https://www.510kdatabase.net/k850756/ 1985-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k850756-auto-d-automatic-disinfection-fda-510k.jpg K850756 - AUTO-D AUTOMATIC DISINFECTION ACCESS/ATTACHMENTS K850756 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Mar 1985. https://www.510kdatabase.net/k850923/ 1985-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k850923-bun-rate-reagent-fda-510k.jpg K850923 - BUN (RATE) REAGENT K850923 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Mar 1985. https://www.510kdatabase.net/k842092/ 1985-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k842092-seralyzer-aris-phenytoin-reagent-strips-fda-510k.jpg K842092 - SERALYZER ARIS PHENYTOIN REAGENT STRIPS K842092 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Mar 1985. https://www.510kdatabase.net/k844642/ 1985-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k844642-acculevel-theophylline-test-fda-510k.jpg K844642 - ACCULEVEL THEOPHYLLINE TEST K844642 is a FDA 510(k) cleared immunology medical device. Manufacturer: Syva Co.. Cleared Mar 1985. https://www.510kdatabase.net/k844955/ 1985-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k844955-seralyzer-potassium-reagent-strips-fda-510k.jpg K844955 - SERALYZER POTASSIUM REAGENT STRIPS, TEST MODULE, & K844955 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Mar 1985. https://www.510kdatabase.net/k845042/ 1985-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k845042-abbott-inpersol-cycler-1000-fda-510k.jpg K845042 - ABBOTT INPERSOL CYCLER 1000 K845042 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1985. https://www.510kdatabase.net/k850641/ 1985-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k850641-caulk-dycal-light-cured-fda-510k.jpg K850641 - CAULK DYCAL LIGHT CURED K850641 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Mar 1985. https://www.510kdatabase.net/k850334/ 1985-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k850334-roche-reagent-for-chloride-for-the-cobas-fda-510k.jpg K850334 - ROCHE REAGENT FOR CHLORIDE, FOR THE COBAS K850334 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Mar 1985. https://www.510kdatabase.net/k844817/ 1985-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k844817-micro-structured-hs3p-proportional-fda-510k.jpg K844817 - MICRO-STRUCTURED HS3P PROPORTIONAL SERIES HIP STEM K844817 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Mar 1985. https://www.510kdatabase.net/k850348/ 1985-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k850348-urotron-rl9-fda-510k.jpg K850348 - UROTRON RL9 K850348 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Mar 1985. https://www.510kdatabase.net/k850485/ 1985-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k850485-rotor-systems-as-400-las-400-fda-510k.jpg K850485 - ROTOR SYSTEMS A/S-400 & LA/S-400 K850485 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Mar 1985. https://www.510kdatabase.net/k850667/ 1985-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k850667-peridochrom-triglycerides-gpo-fda-510k.jpg K850667 - PERIDOCHROM TRIGLYCERIDES GPO K850667 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Mar 1985. https://www.510kdatabase.net/k850739/ 1985-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k850739-amendment-to-labeling-microtrak-hsv-fda-510k.jpg K850739 - AMENDMENT TO LABELING MICROTRAK HSV 1/HSV 2 DIRECT K850739 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Syva Co.. Cleared Mar 1985. https://www.510kdatabase.net/k844693/ 1985-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k844693-peel-away-introducer-set-fda-510k.jpg K844693 - PEEL-AWAY INTRODUCER SET K844693 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Mar 1985. https://www.510kdatabase.net/k844974/ 1985-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k844974-medtronic-5061-endocardial-pacing-lead-fda-510k.jpg K844974 - MEDTRONIC 5061 ENDOCARDIAL PACING LEAD K844974 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Mar 1985. https://www.510kdatabase.net/k843778/ 1985-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k843778-mayo-elbow-ii-fda-510k.jpg K843778 - MAYO ELBOW II K843778 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Mar 1985. https://www.510kdatabase.net/k844645/ 1985-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k844645-qbc-centrifugal-hematology-analyzer-fda-510k.jpg K844645 - QBC CENTRIFUGAL HEMATOLOGY ANALYZER K844645 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1985. https://www.510kdatabase.net/k844906/ 1985-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k844906-threaded-titanium-metal-backed-fda-510k.jpg K844906 - THREADED TITANIUM METAL BACKED ACETABULAR CUP K844906 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Mar 1985. https://www.510kdatabase.net/k844941/ 1985-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k844941-cfe-acetabular-cup-fda-510k.jpg K844941 - CFE ACETABULAR CUP K844941 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Mar 1985. https://www.510kdatabase.net/k850017/ 1985-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k850017-precinorm-h-precipath-h-fda-510k.jpg K850017 - PRECINORM H & PRECIPATH H K850017 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Mar 1985. https://www.510kdatabase.net/k850364/ 1985-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k850364-glucose-trinder-reagent-fda-510k.jpg K850364 - GLUCOSE - TRINDER- REAGENT K850364 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Mar 1985. https://www.510kdatabase.net/k850457/ 1985-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k850457-du-pont-digoxin-assay-calibrator-fda-510k.jpg K850457 - DU PONT DIGOXIN ASSAY CALIBRATOR K850457 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Mar 1985. https://www.510kdatabase.net/k850458/ 1985-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k850458-dupont-digoxin-assay-reagents-fda-510k.jpg K850458 - DUPONT DIGOXIN ASSAY REAGENTS K850458 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Mar 1985. https://www.510kdatabase.net/k850191/ 1985-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k850191-digilab-750-automated-perimeter-wibm-fda-510k.jpg K850191 - DIGILAB 750 AUTOMATED PERIMETER W/IBM PERSON/COMPU K850191 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Bio-Rad. Cleared Mar 1985. https://www.510kdatabase.net/k850376/ 1985-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k850376-terumo-sensibead-eia-tsh-kit-fda-510k.jpg K850376 - TERUMO SENSIBEAD EIA TSH KIT K850376 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Terumo Medical Corp.. Cleared Mar 1985. https://www.510kdatabase.net/k842538/ 1985-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k842538-accutorr-csm-system-fda-510k.jpg K842538 - ACCUTORR CSM SYSTEM K842538 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Mar 1985. https://www.510kdatabase.net/k844218/ 1985-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k844218-tomographic-gantry-fda-510k.jpg K844218 - TOMOGRAPHIC GANTRY K844218 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Mar 1985. https://www.510kdatabase.net/k850373/ 1985-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k850373-abbott-rf-eia-diagnostic-kit-fda-510k.jpg K850373 - ABBOTT RF EIA DIAGNOSTIC KIT K850373 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1985. https://www.510kdatabase.net/k844423/ 1985-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k844423-coat-a-count-free-testosterone-kit-fda-510k.jpg K844423 - COAT-A-COUNT FREE TESTOSTERONE KIT & COMPONENTS K844423 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Feb 1985. https://www.510kdatabase.net/k845012/ 1985-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k845012-nutrient-mixture-f-10-ham-n-1387-wl-fda-510k.jpg K845012 - NUTRIENT MIXTURE F-10 -HAM, N 1387, W/L-GLUTAMINE K845012 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Feb 1985. https://www.510kdatabase.net/k845013/ 1985-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k845013-rpmi-1640-med-wl-glutamine-25mm-hepes-fda-510k.jpg K845013 - RPMI-1640 MED. W/L-GLUTAMINE & 25MM HEPES & W/O SO K845013 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Feb 1985. https://www.510kdatabase.net/k845014/ 1985-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k845014-med-199-wearles-salts-l-glutamine-25mm-fda-510k.jpg K845014 - MED. 199 W/EARLE'S SALTS, L-GLUTAMINE & 25MM HEPES K845014 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Feb 1985. https://www.510kdatabase.net/k850089/ 1985-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k850089-minimum-essential-med-mem-wearles-sals-fda-510k.jpg K850089 - MINIMUM ESSENTIAL MED. (MEM) W/EARLE'S SALS L-GLUT K850089 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Feb 1985. https://www.510kdatabase.net/k850090/ 1985-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k850090-dulbeccos-modified-eagles-med-dme-fda-510k.jpg K850090 - DULBECCO'S MODIFIED EAGLE'S MED. (DME) W/1000 MG/L K850090 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Feb 1985. https://www.510kdatabase.net/k850091/ 1985-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k850091-basal-med-eaglebme-wearles-salts-l-fda-510k.jpg K850091 - BASAL MED. EAGLE(BME) W/EARLE'S SALTS, L-GLUTAMINE K850091 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Feb 1985. https://www.510kdatabase.net/k850092/ 1985-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k850092-dulbeccos-modified-eagles-med-dme-fda-510k.jpg K850092 - DULBECCO'S MODIFIED EAGLE'S MED. (DME) W/GLUCOSE A K850092 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Feb 1985. https://www.510kdatabase.net/k850396/ 1985-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k850396-roche-standards-for-chloride-co2-fda-510k.jpg K850396 - ROCHE STANDARDS FOR CHLORIDE & CO2 K850396 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Feb 1985. https://www.510kdatabase.net/k845030/ 1985-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k845030-cronex-sr342-quanta-fast-detail-fda-510k.jpg K845030 - CRONEX SR342-QUANTA FAST DETAIL-INTENSI-SCREENS K845030 is a FDA 510(k) cleared radiology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Feb 1985. https://www.510kdatabase.net/k844808/ 1985-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k844808-methyl-green-pyronin-stain-procedure-fda-510k.jpg K844808 - METHYL GREEN-PYRONIN STAIN PROCEDURE HT70 K844808 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Feb 1985. https://www.510kdatabase.net/k845005/ 1985-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k845005-brooker-acetabular-cup-fda-510k.jpg K845005 - BROOKER ACETABULAR CUP K845005 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Feb 1985. https://www.510kdatabase.net/k845041/ 1985-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k845041-capd-staged-connector-fda-510k.jpg K845041 - CAPD STAGED CONNECTOR K845041 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Abbott Laboratories. Cleared Feb 1985. https://www.510kdatabase.net/k850406/ 1985-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k850406-automatic-peritoneal-dialysis-cycler-fda-510k.jpg K850406 - AUTOMATIC PERITONEAL DIALYSIS CYCLER SYSTEM K850406 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Feb 1985. https://www.510kdatabase.net/k844428/ 1985-02-20 monthly 0.5 https://www.510kdatabase.net/og-image/k844428-radiotom-804-fda-510k.jpg K844428 - RADIOTOM 804 K844428 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 1985. https://www.510kdatabase.net/k844077/ 1985-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k844077-nutrimix-empty-container-fda-510k.jpg K844077 - NUTRIMIX EMPTY CONTAINER K844077 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Feb 1985. https://www.510kdatabase.net/k844949/ 1985-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k844949-syva-sample-seal-fda-510k.jpg K844949 - SYVA SAMPLE SEAL K844949 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Feb 1985. https://www.510kdatabase.net/k850369/ 1985-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k850369-quinton-white-sealing-cap-fda-510k.jpg K850369 - QUINTON WHITE SEALING CAP K850369 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Quinton, Inc.. Cleared Feb 1985. https://www.510kdatabase.net/k842407/ 1985-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k842407-pulsed-doppler-option-continu-wave-fda-510k.jpg K842407 - PULSED DOPPLER OPTION, CONTINU-WAVE K842407 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Feb 1985. https://www.510kdatabase.net/k844028/ 1985-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k844028-lord-screw-ring-acetabular-component-fda-510k.jpg K844028 - LORD SCREW RING ACETABULAR COMPONENT K844028 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Feb 1985. https://www.510kdatabase.net/k844240/ 1985-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k844240-enzygnost-lipase-test-fda-510k.jpg K844240 - ENZYGNOST LIPASE TEST K844240 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Feb 1985. https://www.510kdatabase.net/k844564/ 1985-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k844564-argyle-laser-resistant-tracheal-tube-fda-510k.jpg K844564 - ARGYLE LASER RESISTANT TRACHEAL TUBE W/MURPHY EYE K844564 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sherwood Medical Co.. Cleared Feb 1985. https://www.510kdatabase.net/k844740/ 1985-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k844740-models-43100a-43110a-43120a-fda-510k.jpg K844740 - MODELS 43100A, 43110A & 43120A DEFIBRILLATOR/MONIT K844740 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Feb 1985. https://www.510kdatabase.net/k844914/ 1985-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k844914-abbott-pregna-plus-human-chorionic-fda-510k.jpg K844914 - ABBOTT PREGNA-PLUS HUMAN CHORIONIC GONADOTROPIN EN K844914 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Feb 1985. https://www.510kdatabase.net/k850146/ 1985-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k850146-siredoc-paper-chart-recorder-fda-510k.jpg K850146 - SIREDOC, PAPER CHART RECORDER K850146 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 1985. https://www.510kdatabase.net/k850319/ 1985-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k850319-y-glutamyltransferasey-gt-reagent-fda-510k.jpg K850319 - Y-GLUTAMYLTRANSFERASE(Y-GT) REAGENT K850319 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Feb 1985. https://www.510kdatabase.net/k831235/ 1985-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k831235-iabp-90-system-fda-510k.jpg K831235 - IABP #90 SYSTEM K831235 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Feb 1985. https://www.510kdatabase.net/k833828/ 1985-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k833828-percor-95-fr-iab-on-datascope-co2-fda-510k.jpg K833828 - PERCOR 9.5 FR IAB ON DATASCOPE CO2 K833828 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Feb 1985. https://www.510kdatabase.net/k844471/ 1985-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k844471-visible-light-cure-composite-polishable-fda-510k.jpg K844471 - VISIBLE LIGHT-CURE COMPOSITE -POLISHABLE K844471 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Feb 1985. https://www.510kdatabase.net/k844793/ 1985-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k844793-suprima-253-21-implantable-pulse-fda-510k.jpg K844793 - SUPRIMA 253-21 IMPLANTABLE PULSE GENERATOR K844793 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Feb 1985. https://www.510kdatabase.net/k844957/ 1985-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k844957-medtronic-model-8436-pacemaker-pulse-fda-510k.jpg K844957 - MEDTRONIC MODEL 8436 -PACEMAKER PULSE GENERATOR K844957 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Feb 1985. https://www.510kdatabase.net/k844958/ 1985-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k844958-medtronic-models-843284338434-fda-510k.jpg K844958 - MEDTRONIC MODELS 8432/8433/8434 - PACEMAKER PULSE K844958 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Feb 1985. https://www.510kdatabase.net/k850073/ 1985-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k850073-j-j-light-curing-dentinenamel-bonding-fda-510k.jpg K850073 - J & J LIGHT CURING DENTIN/ENAMEL BONDING AGENT K850073 is a FDA 510(k) cleared dental medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Feb 1985. https://www.510kdatabase.net/k844355/ 1985-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k844355-synatomic-standard-tibial-plateau-fda-510k.jpg K844355 - SYNATOMIC STANDARD TIBIAL PLATEAU K844355 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Feb 1985. https://www.510kdatabase.net/k844115/ 1985-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k844115-medtronic-3465-se-4f-receiverextension-fda-510k.jpg K844115 - MEDTRONIC 3465 SE-4F RECEIVER/EXTENSION FOR SPINAL K844115 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Feb 1985. https://www.510kdatabase.net/k844996/ 1985-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k844996-paragon-tricheck-electrophoresis-control-fda-510k.jpg K844996 - PARAGON TRICHECK ELECTROPHORESIS CONTROL K844996 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Feb 1985. https://www.510kdatabase.net/k850174/ 1985-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k850174-tdx-ethosuximide-fda-510k.jpg K850174 - TDX ETHOSUXIMIDE K850174 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Feb 1985. https://www.510kdatabase.net/k850281/ 1985-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k850281-calcium-fda-510k.jpg K850281 - CALCIUM K850281 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Feb 1985. https://www.510kdatabase.net/k844098/ 1985-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k844098-canmed-103-fda-510k.jpg K844098 - CANMED 103 K844098 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Feb 1985. https://www.510kdatabase.net/k844294/ 1985-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k844294-cordia-ic-fda-510k.jpg K844294 - CORDIA IC K844294 is a FDA 510(k) cleared immunology medical device. Manufacturer: Cordis Corp.. Cleared Feb 1985. https://www.510kdatabase.net/k850031/ 1985-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k850031-vision-triglycerides-fda-510k.jpg K850031 - VISION TRIGLYCERIDES K850031 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Feb 1985. https://www.510kdatabase.net/k843824/ 1985-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k843824-cobas-fp-reagents-for-phenytoin-calibr-fda-510k.jpg K843824 - COBAS FP REAGENTS FOR PHENYTOIN & CALIBR K843824 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Feb 1985. https://www.510kdatabase.net/k843825/ 1985-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k843825-cobas-reagents-phenobarbital-phenobar-fda-510k.jpg K843825 - COBAS REAGENTS PHENOBARBITAL & PHENOBAR K843825 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Feb 1985. https://www.510kdatabase.net/k843826/ 1985-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k843826-cobas-immunoassay-for-theophylline-cal-fda-510k.jpg K843826 - COBAS IMMUNOASSAY FOR THEOPHYLLINE & CAL K843826 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Feb 1985. https://www.510kdatabase.net/k843827/ 1985-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k843827-cobas-reagents-for-gentamicin-calibrat-fda-510k.jpg K843827 - COBAS REAGENTS FOR GENTAMICIN & CALIBRAT K843827 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Feb 1985. https://www.510kdatabase.net/k843828/ 1985-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k843828-cobas-reagents-for-tobramycin-calibra-fda-510k.jpg K843828 - COBAS REAGENTS FOR TOBRAMYCIN & CALIBRA K843828 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Feb 1985. https://www.510kdatabase.net/k844687/ 1985-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k844687-medtronic-model-6912-fda-510k.jpg K844687 - MEDTRONIC MODEL 6912 K844687 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Feb 1985. https://www.510kdatabase.net/k850008/ 1985-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k850008-sopheiamp-cortisol-eia-kit-fda-510k.jpg K850008 - SOPHEIA/MP CORTISOL EIA KIT K850008 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Feb 1985. https://www.510kdatabase.net/k850128/ 1985-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k850128-syste-mate-tibc-hem-no-67225-fda-510k.jpg K850128 - SYSTE MATE TIBC HEM NO. 67225 K850128 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Feb 1985. https://www.510kdatabase.net/k844571/ 1985-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k844571-campypak-plus-wpalladium-catalyst-fda-510k.jpg K844571 - CAMPYPAK PLUS W/PALLADIUM CATALYST DISPOS. HYDROGE K844571 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jan 1985. https://www.510kdatabase.net/k850110/ 1985-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k850110-vision-formerly-pda-alkaline-phosphatase-fda-510k.jpg K850110 - VISION -FORMERLY PDA- ALKALINE PHOSPHATASE K850110 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jan 1985. https://www.510kdatabase.net/k843899/ 1985-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k843899-grc-wt-grc-w-fda-510k.jpg K843899 - GRC-WT, GRC-W K843899 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Olympus Corp.. Cleared Jan 1985. https://www.510kdatabase.net/k844719/ 1985-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k844719-360-infuser-fda-510k.jpg K844719 - 360 INFUSER K844719 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jan 1985. https://www.510kdatabase.net/k844730/ 1985-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k844730-bard-harvard-mini-infuser-400-multi-fda-510k.jpg K844730 - BARD HARVARD MINI-INFUSER 400 MULTI DOSE SYRINGE K844730 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k845020/ 1985-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k845020-syste-mate-iron-hem-no-67224-fda-510k.jpg K845020 - SYSTE MATE IRON, HEM NO. 67224 K845020 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844091/ 1985-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k844091-abbott-lifecare-900-volumetric-pump-fda-510k.jpg K844091 - ABBOTT LIFECARE 900 VOLUMETRIC PUMP K844091 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Jan 1985. https://www.510kdatabase.net/k844407/ 1985-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k844407-directigen-neissena-menningitidis-fda-510k.jpg K844407 - DIRECTIGEN NEISSENA MENNINGITIDIS GROUP B TEST K844407 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jan 1985. https://www.510kdatabase.net/k844768/ 1985-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k844768-abbott-lifecare-500-infuser-fda-510k.jpg K844768 - ABBOTT LIFECARE 500 INFUSER K844768 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Jan 1985. https://www.510kdatabase.net/k844228/ 1985-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k844228-pds-polydioxanone-mesh-fda-510k.jpg K844228 - PDS POLYDIOXANONE MESH K844228 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844279/ 1985-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k844279-interceptor-662-01-fda-510k.jpg K844279 - INTERCEPTOR, 662-01 K844279 is a FDA 510(k) cleared neurology medical device. Manufacturer: Intermedics, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844584/ 1985-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k844584-gore-tex-tunneler-fda-510k.jpg K844584 - GORE-TEX TUNNELER K844584 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844415/ 1985-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k844415-porocoat-new-jersey-shoulder-fda-510k.jpg K844415 - POROCOAT NEW JERSEY SHOULDER REPLACEMENT SYS K844415 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844449/ 1985-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k844449-high-resolution-5-mhz-linear-array-fda-510k.jpg K844449 - HIGH RESOLUTION 5 MHZ LINEAR ARRAY K844449 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844836/ 1985-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k844836-hemoclip-x-20-automatic-hemoclip-fda-510k.jpg K844836 - HEMOCLIP X-20 AUTOMATIC HEMOCLIP LIGATING APPLIER K844836 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Edward Weck, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844837/ 1985-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k844837-visistat-skin-stapling-device-fda-510k.jpg K844837 - VISISTAT SKIN STAPLING DEVICE K844837 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844838/ 1985-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k844838-skin-stat-ii-skin-stapling-medical-fda-510k.jpg K844838 - SKIN STAT II SKIN STAPLING MEDICAL DEVICE K844838 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844990/ 1985-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k844990-syva-advance-emit-phenytoin-assay-fda-510k.jpg K844990 - SYVA ADVANCE EMIT PHENYTOIN ASSAY K844990 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jan 1985. https://www.510kdatabase.net/k844991/ 1985-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k844991-emit-phenytoin-assay-fda-510k.jpg K844991 - EMIT PHENYTOIN ASSAY K844991 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jan 1985. https://www.510kdatabase.net/k841190/ 1985-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k841190-microtrak-hsv-1-2-direct-speciman-fda-510k.jpg K841190 - MICROTRAK HSV 1 & 2 DIRECT SPECIMAN K841190 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Syva Co.. Cleared Jan 1985. https://www.510kdatabase.net/k842031/ 1985-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k842031-transvenous-tined-ventricularatrial-fda-510k.jpg K842031 - TRANSVENOUS TINED VENTRICULAR/ATRIAL K842031 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jan 1985. https://www.510kdatabase.net/k842032/ 1985-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k842032-models-40124512-transvenous-tined--fda-510k.jpg K842032 - MODELS 4012/4512 TRANSVENOUS TINED- K842032 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jan 1985. https://www.510kdatabase.net/k842065/ 1985-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k842065-epicardial-unipolar-lead-4951-fda-510k.jpg K842065 - EPICARDIAL, UNIPOLAR LEAD 4951 K842065 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jan 1985. https://www.510kdatabase.net/k842145/ 1985-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k842145-transvenous-tined-ventricular-lead-fda-510k.jpg K842145 - TRANSVENOUS TINED VENTRICULAR LEAD K842145 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jan 1985. https://www.510kdatabase.net/k842236/ 1985-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k842236-patient-monitor-78354a-fda-510k.jpg K842236 - PATIENT MONITOR 78354A K842236 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Jan 1985. https://www.510kdatabase.net/k844341/ 1985-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k844341-united-skin-barrier-paste-fda-510k.jpg K844341 - UNITED SKIN BARRIER PASTE K844341 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Howmedica Corp.. Cleared Jan 1985. https://www.510kdatabase.net/k844511/ 1985-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k844511-tdx-total-estriol-fda-510k.jpg K844511 - TDX TOTAL ESTRIOL K844511 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jan 1985. https://www.510kdatabase.net/k844692/ 1985-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k844692-pediatric-sized-hemocath-catheter-fda-510k.jpg K844692 - PEDIATRIC SIZED HEMOCATH CATHETER K844692 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quinton, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844907/ 1985-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k844907-clinifacts-10-data-management-system-fda-510k.jpg K844907 - CLINIFACTS 10 DATA MANAGEMENT SYSTEM K844907 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844911/ 1985-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k844911-arrhythmia-central-ogp-7201-fda-510k.jpg K844911 - ARRHYTHMIA CENTRAL-OGP-7201 K844911 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844945/ 1985-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k844945-emit-imipraminedesipramine-control-fda-510k.jpg K844945 - EMIT IMIPRAMINE/DESIPRAMINE CONTROL K844945 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jan 1985. https://www.510kdatabase.net/k844946/ 1985-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k844946-emit-amitriptylinenortriptyline-control-fda-510k.jpg K844946 - EMIT AMITRIPTYLINE/NORTRIPTYLINE CONTROL K844946 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jan 1985. https://www.510kdatabase.net/k844962/ 1985-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k844962-emit-qst-acetaminophen-assay-fda-510k.jpg K844962 - EMIT QST ACETAMINOPHEN ASSAY K844962 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jan 1985. https://www.510kdatabase.net/k844986/ 1985-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k844986-roche-reagents-reagent-for-uric-acid-fda-510k.jpg K844986 - ROCHE REAGENTS REAGENT FOR URIC ACID K844986 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844987/ 1985-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k844987-roche-reagents-reagent-for-co2-fda-510k.jpg K844987 - ROCHE REAGENTS REAGENT FOR CO2 K844987 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k845027/ 1985-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k845027-kodak-ektachem-clinical-chemistry-slides-fda-510k.jpg K845027 - KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES K845027 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Jan 1985. https://www.510kdatabase.net/k850057/ 1985-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k850057-du-pont-tobramycin-assay-calibrator-fda-510k.jpg K850057 - DU PONT TOBRAMYCIN ASSAY CALIBRATOR K850057 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k850058/ 1985-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k850058-du-pont-tobramycin-assay-reagents-fda-510k.jpg K850058 - DU PONT TOBRAMYCIN ASSAY REAGENTS K850058 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k850059/ 1985-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k850059-du-pont-gentamicin-assay-calibrator-fda-510k.jpg K850059 - DU PONT GENTAMICIN ASSAY CALIBRATOR K850059 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k850060/ 1985-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k850060-du-pont-gentamicin-assay-reagents-fda-510k.jpg K850060 - DU PONT GENTAMICIN ASSAY REAGENTS K850060 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844542/ 1985-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k844542-cystine-tryptic-agar-wdextrose-fda-510k.jpg K844542 - CYSTINE TRYPTIC AGAR W/DEXTROSE K844542 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844543/ 1985-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k844543-cystine-tryptic-agar-wlactose-fda-510k.jpg K844543 - CYSTINE TRYPTIC AGAR W/LACTOSE K844543 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844544/ 1985-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k844544-cystine-tryptic-agar-wmaltose-fda-510k.jpg K844544 - CYSTINE TRYPTIC AGAR W/MALTOSE K844544 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844545/ 1985-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k844545-cystine-tryptic-agar-wmannitol-fda-510k.jpg K844545 - CYSTINE TRYPTIC AGAR W/MANNITOL K844545 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844546/ 1985-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k844546-cystine-tryptic-agar-wsucrose-fda-510k.jpg K844546 - CYSTINE TRYPTIC AGAR W/SUCROSE K844546 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844547/ 1985-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k844547-tryptic-soy-broth-w65sodium-chloride-fda-510k.jpg K844547 - TRYPTIC SOY BROTH W/6.5%SODIUM CHLORIDE K844547 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844548/ 1985-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k844548-urea-agar-fda-510k.jpg K844548 - UREA AGAR K844548 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844756/ 1985-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k844756-st-family-of-hollow-fiber-dialyzers-fda-510k.jpg K844756 - ST FAMILY OF HOLLOW FIBER DIALYZERS K844756 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Jan 1985. https://www.510kdatabase.net/k844143/ 1985-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k844143-olympus-pf-27m-flexible-ureterorenoscope-fda-510k.jpg K844143 - OLYMPUS PF-27M FLEXIBLE URETERORENOSCOPE K844143 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Corp.. Cleared Jan 1985. https://www.510kdatabase.net/k845015/ 1985-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k845015-davol-papillitome-fda-510k.jpg K845015 - DAVOL PAPILLITOME K845015 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k845016/ 1985-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k845016-davol-polypectomy-snare-fda-510k.jpg K845016 - DAVOL POLYPECTOMY SNARE K845016 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k845017/ 1985-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k845017-davol-retrieval-baskets-forceps-fda-510k.jpg K845017 - DAVOL RETRIEVAL BASKETS & FORCEPS K845017 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k845018/ 1985-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k845018-davol-ercp-cannula-fda-510k.jpg K845018 - DAVOL ERCP CANNULA K845018 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k843232/ 1985-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k843232-shiley-hardshell-venous-reservoir-wint-fda-510k.jpg K843232 - SHILEY HARDSHELL VENOUS RESERVOIR W/INT K843232 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844447/ 1985-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k844447-md4-wcharger-cardiopac-3m11-fda-510k.jpg K844447 - M/D4 W/CHARGER (CARDIOPAC 3M11) K844447 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Jan 1985. https://www.510kdatabase.net/k823844/ 1985-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k823844-horizon-ecg-system-fda-510k.jpg K823844 - HORIZON ECG SYSTEM K823844 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k843907/ 1985-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k843907-porous-coated-titanium-knee-prosthes--fda-510k.jpg K843907 - POROUS COATED TITANIUM KNEE PROSTHES- K843907 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844212/ 1985-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k844212-stimtech-sd-clinician-6090-78-8055-fda-510k.jpg K844212 - STIMTECH SD CLINICIAN 6090 #78-8055 K844212 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844213/ 1985-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k844213-stimtech-sd-patient-6089-78-8050-fda-510k.jpg K844213 - STIMTECH SD PATIENT 6089 #78-8050 K844213 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844376/ 1985-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k844376-model-78210a-telemetry-transmitter-fda-510k.jpg K844376 - MODEL 78210A TELEMETRY TRANSMITTER K844376 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Jan 1985. https://www.510kdatabase.net/k844959/ 1985-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k844959-medtronic-6304-630563066506-6506w-fda-510k.jpg K844959 - MEDTRONIC 6304, 6305,6306,6506 & 6506W. TEMP.PACIN K844959 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jan 1985. https://www.510kdatabase.net/k844308/ 1985-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k844308-pit-and-fissure-seaants-fda-510k.jpg K844308 - PIT AND FISSURE SEAANTS K844308 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jan 1985. https://www.510kdatabase.net/k844340/ 1985-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k844340-travenol-reconstitution-device-wadmix-fda-510k.jpg K844340 - TRAVENOL RECONSTITUTION DEVICE W/ADMIX CAP K844340 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Jan 1985. https://www.510kdatabase.net/k843707/ 1985-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k843707-medtronic-6957j-fda-510k.jpg K843707 - MEDTRONIC 6957J K843707 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jan 1985. https://www.510kdatabase.net/k844125/ 1985-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k844125-lyphochek-pregnancy-control-serum-human-fda-510k.jpg K844125 - LYPHOCHEK PREGNANCY CONTROL SERUM HUMAN K844125 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Jan 1985. https://www.510kdatabase.net/k844561/ 1985-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k844561-bard-ureteroscopic-cytology-brush-fda-510k.jpg K844561 - BARD URETEROSCOPIC CYTOLOGY BRUSH K844561 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844755/ 1985-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k844755-focus-urea-nitrogen-fda-510k.jpg K844755 - FOCUS UREA NITROGEN K844755 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jan 1985. https://www.510kdatabase.net/k844211/ 1985-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k844211-concise-light-cured-white-sealant-fda-510k.jpg K844211 - CONCISE LIGHT CURED WHITE SEALANT K844211 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Jan 1985. https://www.510kdatabase.net/k844426/ 1985-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k844426-albumin-bcp-fda-510k.jpg K844426 - ALBUMIN BCP K844426 is a FDA 510(k) cleared immunology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jan 1985. https://www.510kdatabase.net/k844513/ 1985-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k844513-v-agar-fda-510k.jpg K844513 - V AGAR K844513 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844514/ 1985-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k844514-dtm-agar-fda-510k.jpg K844514 - DTM AGAR K844514 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844515/ 1985-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k844515-violet-red-bile-agar-fda-510k.jpg K844515 - VIOLET RED BILE AGAR K844515 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844516/ 1985-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k844516-starch-hydrolysis-agar-windicator-fda-510k.jpg K844516 - STARCH HYDROLYSIS AGAR W/INDICATOR K844516 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844517/ 1985-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k844517-columbia-cna-agar-w5-sheep-blood-fda-510k.jpg K844517 - COLUMBIA CNA AGAR W/5% SHEEP BLOOD K844517 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844518/ 1985-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k844518-streptococcus-selective-agar-fda-510k.jpg K844518 - STREPTOCOCCUS SELECTIVE AGAR K844518 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844519/ 1985-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k844519-haemophilus-id-quad-fda-510k.jpg K844519 - HAEMOPHILUS I.D. QUAD K844519 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844520/ 1985-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k844520-kliger-iron-agar-fda-510k.jpg K844520 - KLIGER IRON AGAR K844520 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844521/ 1985-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k844521-sim-medium-fda-510k.jpg K844521 - SIM MEDIUM K844521 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844522/ 1985-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k844522-sf-broth-fda-510k.jpg K844522 - SF BROTH K844522 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844523/ 1985-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k844523-campylobacter-thioglycollate-medium-fda-510k.jpg K844523 - CAMPYLOBACTER THIOGLYCOLLATE MEDIUM K844523 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844524/ 1985-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k844524-gn-broth-fda-510k.jpg K844524 - GN BROTH K844524 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844525/ 1985-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k844525-selenite-cystine-broth-fda-510k.jpg K844525 - SELENITE CYSTINE BROTH K844525 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844526/ 1985-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k844526-thioglycollate-wo-dextrose-or-indicator-fda-510k.jpg K844526 - THIOGLYCOLLATE W/O DEXTROSE OR INDICATOR K844526 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844527/ 1985-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k844527-selenite-broth-fda-510k.jpg K844527 - SELENITE BROTH K844527 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844528/ 1985-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k844528-nutrient-broth-fda-510k.jpg K844528 - NUTRIENT BROTH K844528 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844529/ 1985-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k844529-brain-heart-infusion-broth-fda-510k.jpg K844529 - BRAIN HEART INFUSION BROTH K844529 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844530/ 1985-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k844530-brain-heart-infusion-w65-sodium-chloride-fda-510k.jpg K844530 - BRAIN HEART INFUSION W/6.5% SODIUM CHLORIDE K844530 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844531/ 1985-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k844531-triple-sugar-iron-fda-510k.jpg K844531 - TRIPLE SUGAR IRON K844531 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844532/ 1985-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k844532-simmons-citrate-agar-fda-510k.jpg K844532 - SIMMONS CITRATE AGAR K844532 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844533/ 1985-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k844533-trichomonas-broth-fda-510k.jpg K844533 - TRICHOMONAS BROTH K844533 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844534/ 1985-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k844534-campylobacter-cva-agar-fda-510k.jpg K844534 - CAMPYLOBACTER CVA AGAR K844534 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844536/ 1985-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k844536-thioglycollate-wo-indicator-fda-510k.jpg K844536 - THIOGLYCOLLATE W/O INDICATOR K844536 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844537/ 1985-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k844537-fluid-thioglycollate-medium-windicator-fda-510k.jpg K844537 - FLUID THIOGLYCOLLATE MEDIUM W/INDICATOR K844537 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844538/ 1985-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k844538-cooked-meat-medium-fda-510k.jpg K844538 - COOKED MEAT MEDIUM K844538 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844539/ 1985-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k844539-phenol-red-broth-wcarbohydrates-fda-510k.jpg K844539 - PHENOL RED BROTH W/CARBOHYDRATES K844539 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844540/ 1985-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k844540-cystine-tryptic-agar-wfructose-fda-510k.jpg K844540 - CYSTINE TRYPTIC AGAR W/FRUCTOSE K844540 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844541/ 1985-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k844541-tryptic-soy-broth-fda-510k.jpg K844541 - TRYPTIC SOY BROTH K844541 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844655/ 1985-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k844655-peridochrom-cholesterol-high-performance-fda-510k.jpg K844655 - PERIDOCHROM CHOLESTEROL HIGH PERFORMANCE K844655 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jan 1985. https://www.510kdatabase.net/k844535/ 1985-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k844535-yersinia-selective-agar-fda-510k.jpg K844535 - YERSINIA SELECTIVE AGAR K844535 is a FDA 510(k) cleared microbiology medical device. Manufacturer: bioMerieux, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k843417/ 1985-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k843417-cordia-t-m-fda-510k.jpg K843417 - CORDIA T-M K843417 is a FDA 510(k) cleared immunology medical device. Manufacturer: Cordis Corp.. Cleared Jan 1985. https://www.510kdatabase.net/k843713/ 1985-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k843713-directigen-group-a-strep-test-kit-fda-510k.jpg K843713 - DIRECTIGEN GROUP A STREP TEST KIT K843713 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jan 1985. https://www.510kdatabase.net/k843727/ 1985-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k843727-leukostix-reagent-strips-for-urinalysis-fda-510k.jpg K843727 - LEUKOSTIX REAGENT STRIPS FOR URINALYSIS K843727 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Jan 1985. https://www.510kdatabase.net/k844402/ 1985-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k844402-sigma-peroxidase-myeloperoxidase-fda-510k.jpg K844402 - SIGMA PEROXIDASE MYELOPEROXIDASE STAINING PROCEDUR K844402 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Jan 1985. https://www.510kdatabase.net/k843084/ 1985-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k843084-olympus-chp-p10-nephroscopecystoscope-fda-510k.jpg K843084 - OLYMPUS CHP-P10 NEPHROSCOPE/CYSTOSCOPE K843084 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Corp.. Cleared Jan 1985. https://www.510kdatabase.net/k843748/ 1985-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k843748-anti-aspiration-valve-fda-510k.jpg K843748 - ANTI-ASPIRATION VALVE K843748 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Jan 1985. https://www.510kdatabase.net/k844161/ 1985-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k844161-ptca-guiding-cather-fda-510k.jpg K844161 - PTCA GUIDING CATHER K844161 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Jan 1985. https://www.510kdatabase.net/k828543/ 1985-01-01 monthly 0.5 https://www.510kdatabase.net/og-image/k828543-unknown-fda-510k.jpg K828543 - UNKNOWN K828543 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jan 1985. https://www.510kdatabase.net/k811259/ 1984-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k811259-cordis-encor-atrial-lead-fda-510k.jpg K811259 - CORDIS ENCOR ATRIAL LEAD K811259 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Dec 1984. https://www.510kdatabase.net/k842218/ 1984-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k842218-anti-leu-4-fitc-lysin-c-buffer-fda-510k.jpg K842218 - ANTI-LEU-4 FITC LYSIN C BUFFER K842218 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Dec 1984. https://www.510kdatabase.net/k843320/ 1984-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k843320-rt-50-fda-510k.jpg K843320 - RT-50 K843320 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Dec 1984. https://www.510kdatabase.net/k843706/ 1984-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k843706-medtronic-6957-fda-510k.jpg K843706 - MEDTRONIC 6957 K843706 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Dec 1984. https://www.510kdatabase.net/k843802/ 1984-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k843802-stockert-shiley-universal-level-sensor-fda-510k.jpg K843802 - STOCKERT-SHILEY UNIVERSAL LEVEL SENSOR K843802 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Dec 1984. https://www.510kdatabase.net/k844099/ 1984-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k844099-canmed-102-fda-510k.jpg K844099 - CANMED 102 K844099 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Dec 1984. https://www.510kdatabase.net/k844100/ 1984-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k844100-canmed-101-fda-510k.jpg K844100 - CANMED 101 K844100 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Dec 1984. https://www.510kdatabase.net/k844137/ 1984-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k844137-stockert-shiley-venous-catheter-aortic-fda-510k.jpg K844137 - STOCKERT-SHILEY VENOUS CATHETER & AORTIC ARCH CANN K844137 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Dec 1984. https://www.510kdatabase.net/k844138/ 1984-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k844138-stockert-shiley-handheld-remote-fda-510k.jpg K844138 - STOCKERT-SHILEY HANDHELD REMOTE CONTROL INTRACARDI K844138 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Dec 1984. https://www.510kdatabase.net/k844139/ 1984-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k844139-stockert-shiley-intracardiac-suckers-fda-510k.jpg K844139 - STOCKERT-SHILEY INTRACARDIAC SUCKERS K844139 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Dec 1984. https://www.510kdatabase.net/k844140/ 1984-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k844140-stockert-shiley-atrial-left-fda-510k.jpg K844140 - STOCKERT-SHILEY ATRIAL LEFT VENTRICULAR VENT CATH K844140 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Dec 1984. https://www.510kdatabase.net/k843978/ 1984-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k843978-enaii-test-kitss-aro-ss-bla-autoantibody-fda-510k.jpg K843978 - ENAII TEST KIT(SS-A(RO) & SS-B(LA) AUTOANTIBODY K843978 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Dec 1984. https://www.510kdatabase.net/k843264/ 1984-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k843264-monoject-menghini-soft-tissue-biopsy-fda-510k.jpg K843264 - MONOJECT MENGHINI SOFT TISSUE BIOPSY K843264 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Dec 1984. https://www.510kdatabase.net/k843695/ 1984-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k843695-qca-hemoglobin-kit-fda-510k.jpg K843695 - QCA HEMOGLOBIN KIT K843695 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Dec 1984. https://www.510kdatabase.net/k843918/ 1984-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k843918-corometrics-fetal-monitor-142-fda-510k.jpg K843918 - COROMETRICS FETAL MONITOR 142 K843918 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Dec 1984. https://www.510kdatabase.net/k843927/ 1984-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k843927-ct-9000-fda-510k.jpg K843927 - CT 9000 K843927 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Dec 1984. https://www.510kdatabase.net/k844280/ 1984-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k844280-travenol-value-line-urinary-drainage-fda-510k.jpg K844280 - TRAVENOL VALUE-LINE URINARY DRAINAGE BAG W/STERILE K844280 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Dec 1984. https://www.510kdatabase.net/k844020/ 1984-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k844020-pyridoxal-disc-fda-510k.jpg K844020 - PYRIDOXAL DISC K844020 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Dec 1984. https://www.510kdatabase.net/k843294/ 1984-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k843294-med-dynamics-satican-video-camera-5410-fda-510k.jpg K843294 - MED. DYNAMICS SATICAN VIDEO CAMERA 5410 K843294 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medline Industries, Inc.. Cleared Dec 1984. https://www.510kdatabase.net/k843295/ 1984-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k843295-med-dynamics-high-resolution-solid-st-fda-510k.jpg K843295 - MED. DYNAMICS HIGH RESOLUTION SOLID ST K843295 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medline Industries, Inc.. Cleared Dec 1984. https://www.510kdatabase.net/k844581/ 1984-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k844581-80-mgdl-glucose-control-fda-510k.jpg K844581 - 80 MG/DL GLUCOSE CONTROL K844581 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Dec 1984. https://www.510kdatabase.net/k843101/ 1984-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k843101-karl-storz-27086kc-ultrasonic-lithotri-fda-510k.jpg K843101 - KARL STORZ 27086KC ULTRASONIC LITHOTRI K843101 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Dec 1984. https://www.510kdatabase.net/k844097/ 1984-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k844097-canmed-103-9300-electrode-fda-510k.jpg K844097 - CANMED 103 9300 ELECTRODE K844097 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Dec 1984. https://www.510kdatabase.net/k844170/ 1984-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k844170-theophylline-radioimmunoassay-aria-ht-fda-510k.jpg K844170 - THEOPHYLLINE RADIOIMMUNOASSAY ARIA HT SYSTEM K844170 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Dec 1984. https://www.510kdatabase.net/k844204/ 1984-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k844204-emit-qst-ethosuximide-assay-fda-510k.jpg K844204 - EMIT QST ETHOSUXIMIDE ASSAY K844204 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Dec 1984. https://www.510kdatabase.net/k844468/ 1984-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k844468-triglyceride-calibrator-fda-510k.jpg K844468 - TRIGLYCERIDE CALIBRATOR K844468 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Dec 1984. https://www.510kdatabase.net/k844553/ 1984-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k844553-micra-diamond-knife-micra-adjustable-fda-510k.jpg K844553 - MICRA DIAMOND KNIFE MICRA ADJUSTABLE KNIFE K844553 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Dec 1984. https://www.510kdatabase.net/k844585/ 1984-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k844585-referril-calibrators-fda-510k.jpg K844585 - REFERRIL CALIBRATORS K844585 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Dec 1984. https://www.510kdatabase.net/k844586/ 1984-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k844586-il-genesis-21-clinical-chemistry-fda-510k.jpg K844586 - IL GENESIS 21, CLINICAL CHEMISTRY ANALYTICAL SYS K844586 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Dec 1984. https://www.510kdatabase.net/k842880/ 1984-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k842880-mechanical-sector-probe-4-mhz-dfm-fda-510k.jpg K842880 - MECHANICAL SECTOR PROBE 4 MHZ DFM K842880 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Dec 1984. https://www.510kdatabase.net/k844171/ 1984-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k844171-phenytoin-radioimmunoassay-using-the-fda-510k.jpg K844171 - PHENYTOIN RADIOIMMUNOASSAY USING THE ARIA HT SYSTE K844171 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Dec 1984. https://www.510kdatabase.net/k844398/ 1984-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k844398-coat-a-count-androstenedione-ria-kit-fda-510k.jpg K844398 - COAT-A-COUNT ANDROSTENEDIONE RIA KIT K844398 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Dec 1984. https://www.510kdatabase.net/k842370/ 1984-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k842370-page-writer-interpretive-cardiograph-fda-510k.jpg K842370 - PAGE-WRITER INTERPRETIVE CARDIOGRAPH K842370 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Dec 1984. https://www.510kdatabase.net/k843352/ 1984-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k843352-coloscreen-self-test-fda-510k.jpg K843352 - COLOSCREEN SELF-TEST K843352 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Dec 1984. https://www.510kdatabase.net/k843889/ 1984-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k843889-respironics-sleepeasy-nasal-cpap-sys-fda-510k.jpg K843889 - RESPIRONICS SLEEPEASY NASAL CPAP SYS K843889 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Dec 1984. https://www.510kdatabase.net/k843967/ 1984-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k843967-enzygnost-beta-2-microglobulin-test-fda-510k.jpg K843967 - ENZYGNOST BETA-2 MICROGLOBULIN TEST K843967 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Dec 1984. https://www.510kdatabase.net/k843201/ 1984-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k843201-heparin-aca-analytical-test-pack-fda-510k.jpg K843201 - HEPARIN ACA ANALYTICAL TEST PACK K843201 is a FDA 510(k) cleared hematology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Nov 1984. https://www.510kdatabase.net/k843202/ 1984-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k843202-heparin-calibrator-aca-fda-510k.jpg K843202 - HEPARIN CALIBRATOR ACA K843202 is a FDA 510(k) cleared hematology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Nov 1984. https://www.510kdatabase.net/k843949/ 1984-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k843949-iv-pump-administration-set-fda-510k.jpg K843949 - I.V. PUMP ADMINISTRATION SET K843949 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Nov 1984. https://www.510kdatabase.net/k842884/ 1984-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k842884-surgeons-gloves-fda-510k.jpg K842884 - SURGEON'S GLOVES K842884 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Nov 1984. https://www.510kdatabase.net/k843219/ 1984-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k843219-zimmer-bone-cement-centrifugation-sys-fda-510k.jpg K843219 - ZIMMER BONE CEMENT CENTRIFUGATION SYS K843219 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Nov 1984. https://www.510kdatabase.net/k843385/ 1984-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k843385-corometrics-115-fetal-monitor-fda-510k.jpg K843385 - COROMETRICS 115 FETAL MONITOR K843385 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Nov 1984. https://www.510kdatabase.net/k843502/ 1984-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k843502-3m-laser-imager-fda-510k.jpg K843502 - 3M LASER IMAGER K843502 is a FDA 510(k) cleared radiology medical device. Manufacturer: 3M Company. Cleared Nov 1984. https://www.510kdatabase.net/k844046/ 1984-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k844046-united-skin-barriers-fda-510k.jpg K844046 - UNITED SKIN BARRIERS K844046 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Howmedica Corp.. Cleared Nov 1984. https://www.510kdatabase.net/k844406/ 1984-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k844406-johnson-john-son-ostomy-paste-fda-510k.jpg K844406 - JOHNSON & JOHN SON OSTOMY PASTE PROTECTIVWE SKIN K844406 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Nov 1984. https://www.510kdatabase.net/k843914/ 1984-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k843914-cobas-fluorescence-polarization-module-fda-510k.jpg K843914 - COBAS FLUORESCENCE POLARIZATION MODULE K843914 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Nov 1984. https://www.510kdatabase.net/k844070/ 1984-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k844070-tdx-salicylate-fda-510k.jpg K844070 - TDX SALICYLATE K844070 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1984. https://www.510kdatabase.net/k844114/ 1984-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k844114-add-1-fda-510k.jpg K844114 - ADD-1 K844114 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1984. https://www.510kdatabase.net/k844167/ 1984-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k844167-aria-ht-phenobarbital-radioimmunoassay-fda-510k.jpg K844167 - ARIA HT PHENOBARBITAL RADIOIMMUNOASSAY KIT K844167 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Nov 1984. https://www.510kdatabase.net/k840566/ 1984-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k840566-bone-stapling-fixation-sys-fda-510k.jpg K840566 - BONE STAPLING FIXATION SYS K840566 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 3M Company. Cleared Nov 1984. https://www.510kdatabase.net/k843076/ 1984-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k843076-suction-catheter-kit-fda-510k.jpg K843076 - SUCTION CATHETER KIT K843076 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Nov 1984. https://www.510kdatabase.net/k844030/ 1984-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k844030-accumeter-electronic-urinemeter-system-fda-510k.jpg K844030 - ACCUMETER ELECTRONIC URINEMETER SYSTEM K844030 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Nov 1984. https://www.510kdatabase.net/k843215/ 1984-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k843215-factor-ix-deficient-plasma-b9d--fda-510k.jpg K843215 - FACTOR IX DEFICIENT PLASMA, B9D - K843215 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Chemical Co.. Cleared Nov 1984. https://www.510kdatabase.net/k843310/ 1984-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k843310-factor-x-deficient-plasma-blod-human-fda-510k.jpg K843310 - FACTOR X DEFICIENT PLASMA, BLOD HUMAN K843310 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Chemical Co.. Cleared Nov 1984. https://www.510kdatabase.net/k843438/ 1984-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k843438-factor-xi-deficient-plasma-b11d-fda-510k.jpg K843438 - FACTOR XI DEFICIENT PLASMA B11D K843438 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Chemical Co.. Cleared Nov 1984. https://www.510kdatabase.net/k843451/ 1984-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k843451-factor-xii-deficient-plasma-b12d-fda-510k.jpg K843451 - FACTOR XII DEFICIENT PLASMA B12D K843451 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Chemical Co.. Cleared Nov 1984. https://www.510kdatabase.net/k844158/ 1984-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k844158-stratus-ferritin-fluorometric-enzyme-fda-510k.jpg K844158 - STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY K844158 is a FDA 510(k) cleared immunology medical device. Manufacturer: American Dade. Cleared Nov 1984. https://www.510kdatabase.net/k844289/ 1984-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k844289-series-is-infections-fda-510k.jpg K844289 - SERIES I/S INFECTIONS K844289 is a FDA 510(k) cleared immunology medical device. Manufacturer: American Dade. Cleared Nov 1984. https://www.510kdatabase.net/k843190/ 1984-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k843190-hap-acetabular-cup-fda-510k.jpg K843190 - HAP ACETABULAR CUP K843190 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Nov 1984. https://www.510kdatabase.net/k844144/ 1984-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k844144-scd-sterile-connection-device-fda-510k.jpg K844144 - SCD STERILE CONNECTION DEVICE K844144 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Nov 1984. https://www.510kdatabase.net/k843331/ 1984-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k843331-intermedicsgraseby-dynamics-ms-36-fda-510k.jpg K843331 - INTERMEDICS/GRASEBY DYNAMICS MS 36 K843331 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Intermedics, Inc.. Cleared Nov 1984. https://www.510kdatabase.net/k843450/ 1984-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k843450-argyle-silicone-central-venous-cath--fda-510k.jpg K843450 - ARGYLE SILICONE CENTRAL VENOUS CATH- K843450 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Nov 1984. https://www.510kdatabase.net/k843909/ 1984-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k843909-titanium-hip-1019-fda-510k.jpg K843909 - TITANIUM HIP 1019 K843909 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Nov 1984. https://www.510kdatabase.net/k843951/ 1984-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k843951-sirognathograph-fda-510k.jpg K843951 - SIROGNATHOGRAPH K843951 is a FDA 510(k) cleared dental medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Nov 1984. https://www.510kdatabase.net/k834212/ 1984-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k834212-n-channel-fda-510k.jpg K834212 - N-CHANNEL K834212 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Nov 1984. https://www.510kdatabase.net/k842381/ 1984-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k842381-sls-3500-led-visual-stimulator-fda-510k.jpg K842381 - SLS 3500 LED VISUAL STIMULATOR K842381 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Nov 1984. https://www.510kdatabase.net/k842669/ 1984-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k842669-titan-gel-iso-dot-ldh-kit-fda-510k.jpg K842669 - TITAN GEL ISO DOT LDH KIT K842669 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Nov 1984. https://www.510kdatabase.net/k844032/ 1984-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k844032-triglyceride-reagent-fda-510k.jpg K844032 - TRIGLYCERIDE REAGENT K844032 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Nov 1984. https://www.510kdatabase.net/k840815/ 1984-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k840815-luer-locking-adaptermaterial-change-fda-510k.jpg K840815 - LUER LOCKING ADAPTER(MATERIAL CHANGE) K840815 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Quinton, Inc.. Cleared Nov 1984. https://www.510kdatabase.net/k842718/ 1984-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k842718-hydroxyapatite-fda-510k.jpg K842718 - HYDROXYAPATITE K842718 is a FDA 510(k) cleared dental medical device. Manufacturer: Depuy, Inc.. Cleared Nov 1984. https://www.510kdatabase.net/k844231/ 1984-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k844231-sceptor-beta-lactam-plus-mic-panel-fda-510k.jpg K844231 - SCEPTOR BETA-LACTAM PLUS MIC PANEL K844231 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Nov 1984. https://www.510kdatabase.net/k842511/ 1984-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k842511-band-aid-brand-adhesive-bandage-medica-fda-510k.jpg K842511 - BAND-AID BRAND ADHESIVE BANDAGE-MEDICA K842511 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Nov 1984. https://www.510kdatabase.net/k843109/ 1984-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k843109-roche-reagent-for-ast-fda-510k.jpg K843109 - ROCHE REAGENT FOR AST K843109 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Nov 1984. https://www.510kdatabase.net/k843540/ 1984-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k843540-abbott-htsh-eia-diagnostic-kit-fda-510k.jpg K843540 - ABBOTT HTSH EIA DIAGNOSTIC KIT K843540 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1984. https://www.510kdatabase.net/k843187/ 1984-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k843187-cannula-fda-510k.jpg K843187 - CANNULA K843187 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Oct 1984. https://www.510kdatabase.net/k843548/ 1984-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k843548-intermedics-syringe-pump-710-02-fda-510k.jpg K843548 - INTERMEDICS SYRINGE PUMP 710-02 K843548 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Intermedics, Inc.. Cleared Oct 1984. https://www.510kdatabase.net/k843603/ 1984-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k843603-auto-suture-poly-gia-surgical-stapler-fda-510k.jpg K843603 - AUTO SUTURE POLY GIA SURGICAL STAPLER K843603 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Oct 1984. https://www.510kdatabase.net/k843684/ 1984-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k843684-sigma-sudan-black-reagent-380-1-fda-510k.jpg K843684 - SIGMA SUDAN BLACK REAGENT 380-1 K843684 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Chemical Co.. Cleared Oct 1984. https://www.510kdatabase.net/k843872/ 1984-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k843872-ethanol-controls-low-high-e5133e5258-fda-510k.jpg K843872 - ETHANOL CONTROLS LOW & HIGH E5133/E5258 K843872 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Oct 1984. https://www.510kdatabase.net/k843997/ 1984-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k843997-ao-10-automated-osmometer-fda-510k.jpg K843997 - AO-10 AUTOMATED OSMOMETER K843997 is a FDA 510(k) cleared chemistry medical device. Manufacturer: bioMerieux, Inc.. Cleared Oct 1984. https://www.510kdatabase.net/k844019/ 1984-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k844019-strep-id-triplate-fda-510k.jpg K844019 - STREP ID TRIPLATE K844019 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Oct 1984. https://www.510kdatabase.net/k843752/ 1984-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k843752-sigma-periodic-acid-schiff-stain-395-fda-510k.jpg K843752 - SIGMA PERIODIC ACID-SCHIFF STAIN 395 K843752 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Chemical Co.. Cleared Oct 1984. https://www.510kdatabase.net/k843870/ 1984-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k843870-parathyroid-hormone-mid-molecule-ria-kit-fda-510k.jpg K843870 - PARATHYROID HORMONE MID-MOLECULE RIA-KIT K843870 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Oct 1984. https://www.510kdatabase.net/k843871/ 1984-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k843871-parathyroid-hormone-c-terminal-ria-kit-fda-510k.jpg K843871 - PARATHYROID HORMONE C-TERMINAL RIA KIT K843871 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Oct 1984. https://www.510kdatabase.net/k843913/ 1984-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k843913-cobas-fp-tdm-controls-fda-510k.jpg K843913 - COBAS FP TDM CONTROLS K843913 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Oct 1984. https://www.510kdatabase.net/k843916/ 1984-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k843916-tdx-rea-creatinine-fda-510k.jpg K843916 - TDX REA CREATININE K843916 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1984. https://www.510kdatabase.net/k843987/ 1984-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k843987-pyr-broth-fda-510k.jpg K843987 - PYR BROTH K843987 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Oct 1984. https://www.510kdatabase.net/k844011/ 1984-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k844011-focus-uric-acid-fda-510k.jpg K844011 - FOCUS URIC ACID K844011 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1984. https://www.510kdatabase.net/k843586/ 1984-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k843586-thora-klex-autotransfusion-kit-fda-510k.jpg K843586 - THORA-KLEX AUTOTRANSFUSION KIT K843586 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 1984. https://www.510kdatabase.net/k843896/ 1984-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k843896-rheumadx-latex-agglutination-rheumatoid-fda-510k.jpg K843896 - RHEUMADX LATEX AGGLUTINATION RHEUMATOID K843896 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Oct 1984. https://www.510kdatabase.net/k841613/ 1984-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k841613-pressure-transducer-dome-1295c-fda-510k.jpg K841613 - PRESSURE TRANSDUCER DOME 1295C K841613 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Oct 1984. https://www.510kdatabase.net/k841868/ 1984-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k841868-mingograf-7-fda-510k.jpg K841868 - MINGOGRAF 7 K841868 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Oct 1984. https://www.510kdatabase.net/k842818/ 1984-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k842818-cst-fda-510k.jpg K842818 - CST K842818 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1984. https://www.510kdatabase.net/k843935/ 1984-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k843935-modification-microtrak-direct-specimen-fda-510k.jpg K843935 - MODIFICATION MICROTRAK DIRECT SPECIMEN TEST K843935 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Syva Co.. Cleared Oct 1984. https://www.510kdatabase.net/k843631/ 1984-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k843631-miniset-vein-infusion-sets-fda-510k.jpg K843631 - MINISET VEIN INFUSION SETS K843631 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Oct 1984. https://www.510kdatabase.net/k843729/ 1984-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k843729-shiley-dispos-cannula-fenestrated-low-fda-510k.jpg K843729 - SHILEY DISPOS. CANNULA FENESTRATED LOW K843729 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shiley, Inc.. Cleared Oct 1984. https://www.510kdatabase.net/k843730/ 1984-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k843730-shiley-dispos-decannulation-plug-wsw-fda-510k.jpg K843730 - SHILEY DISPOS. DECANNULATION PLUG W/SW/ K843730 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shiley, Inc.. Cleared Oct 1984. https://www.510kdatabase.net/k841416/ 1984-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k841416-pediatric-diag-criteria-option-5600c-fda-510k.jpg K841416 - PEDIATRIC DIAG. CRITERIA OPTION 5600C K841416 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Oct 1984. https://www.510kdatabase.net/k842885/ 1984-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k842885-extended-life-capd-solution-transfer-fda-510k.jpg K842885 - EXTENDED LIFE CAPD SOLUTION TRANSFER K842885 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Oct 1984. https://www.510kdatabase.net/k843287/ 1984-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k843287-arrhythmia-central-occ-7101-fda-510k.jpg K843287 - ARRHYTHMIA CENTRAL OCC-7101 K843287 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Oct 1984. https://www.510kdatabase.net/k843444/ 1984-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k843444-argyle-silicone-left-ventricular-and-fda-510k.jpg K843444 - ARGYLE SILICONE LEFT VENTRICULAR AND K843444 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sherwood Medical Co.. Cleared Oct 1984. https://www.510kdatabase.net/k843542/ 1984-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k843542-shiley-coronary-cardioplegia-adaptor-fda-510k.jpg K843542 - SHILEY CORONARY CARDIOPLEGIA ADAPTOR K843542 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Oct 1984. https://www.510kdatabase.net/k843632/ 1984-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k843632-hollow-fiber-dialyzer-fda-510k.jpg K843632 - HOLLOW FIBER DIALYZER K843632 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Oct 1984. https://www.510kdatabase.net/k841243/ 1984-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k841243-enzygnost-rotavirus-ag-fda-510k.jpg K841243 - ENZYGNOST ROTAVIRUS AG K841243 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Oct 1984. https://www.510kdatabase.net/k842717/ 1984-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k842717-cobas-fibro-fda-510k.jpg K842717 - COBAS-FIBRO K842717 is a FDA 510(k) cleared hematology medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Oct 1984. https://www.510kdatabase.net/k843837/ 1984-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k843837-medtronic-5984-5984lp-5985-fda-510k.jpg K843837 - MEDTRONIC 5984-5984LP-5985 K843837 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Oct 1984. https://www.510kdatabase.net/k831822/ 1984-10-16 monthly 0.5 https://www.510kdatabase.net/og-image/k831822-tetraflex-integrally-supported-ptfe-fda-510k.jpg K831822 - TETRAFLEX INTEGRALLY SUPPORTED PTFE K831822 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Oct 1984. https://www.510kdatabase.net/k842689/ 1984-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k842689-glyco-tek-affinity-column-fda-510k.jpg K842689 - GLYCO-TEK AFFINITY COLUMN K842689 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Oct 1984. https://www.510kdatabase.net/k843209/ 1984-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k843209-phenytoin-aca-analytical-test-pack-fda-510k.jpg K843209 - PHENYTOIN ACA ANALYTICAL TEST PACK K843209 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Oct 1984. https://www.510kdatabase.net/k843305/ 1984-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k843305-davol-gauderer-ponsky-percutan-endoscop-fda-510k.jpg K843305 - DAVOL GAUDERER-PONSKY PERCUTAN-ENDOSCOP K843305 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 1984. https://www.510kdatabase.net/k843529/ 1984-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k843529-astra-systems-amylase-reagent-kit-fda-510k.jpg K843529 - ASTRA SYSTEMS AMYLASE REAGENT KIT K843529 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Oct 1984. https://www.510kdatabase.net/k843111/ 1984-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k843111-roche-reagent-for-alt-fda-510k.jpg K843111 - ROCHE REAGENT FOR ALT K843111 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Oct 1984. https://www.510kdatabase.net/k843283/ 1984-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k843283-boehringer-mannheim-diagnostics-adam-fda-510k.jpg K843283 - BOEHRINGER MANNHEIM DIAGNOSTICS ADAM K843283 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Oct 1984. https://www.510kdatabase.net/k843347/ 1984-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k843347-rianen-anit-double-stranded-deoxyribon-fda-510k.jpg K843347 - RIANEN ANIT-DOUBLE STRANDED DEOXYRIBON K843347 is a FDA 510(k) cleared immunology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Oct 1984. https://www.510kdatabase.net/k843419/ 1984-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k843419-emit-700-cannabinoid-control-set-fda-510k.jpg K843419 - EMIT 700 CANNABINOID CONTROL SET K843419 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Oct 1984. https://www.510kdatabase.net/k843556/ 1984-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k843556-emit-dau-cocaine-assay-fda-510k.jpg K843556 - EMIT D.A.U. COCAINE ASSAY K843556 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Oct 1984. https://www.510kdatabase.net/k843605/ 1984-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k843605-emit-700-methaqualone-assay-fda-510k.jpg K843605 - EMIT 700 METHAQUALONE ASSAY K843605 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Oct 1984. https://www.510kdatabase.net/k841256/ 1984-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k841256-models-78551a-78552a-fda-510k.jpg K841256 - MODELS 78551A 78552A K841256 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Oct 1984. https://www.510kdatabase.net/k843492/ 1984-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k843492-neomycin-blood-agar-fda-510k.jpg K843492 - NEOMYCIN BLOOD AGAR K843492 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1984. https://www.510kdatabase.net/k842144/ 1984-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k842144-gore-tex-vascular-graft-fep-ringed-fda-510k.jpg K842144 - GORE-TEX VASCULAR GRAFT, FEP-RINGED K842144 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Oct 1984. https://www.510kdatabase.net/k842537/ 1984-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k842537-von-willebrand-factor-antigen-screen-fda-510k.jpg K842537 - VON WILLEBRAND FACTOR ANTIGEN SCREEN K842537 is a FDA 510(k) cleared hematology medical device. Manufacturer: American Dade. Cleared Oct 1984. https://www.510kdatabase.net/k842617/ 1984-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k842617-vonwillebrand-factor-antigen-semi-quant-fda-510k.jpg K842617 - VONWILLEBRAND FACTOR ANTIGEN SEMI-QUANT K842617 is a FDA 510(k) cleared hematology medical device. Manufacturer: American Dade. Cleared Oct 1984. https://www.510kdatabase.net/k842654/ 1984-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k842654-epsilon-hcg-test-kit-monoclonal-fda-510k.jpg K842654 - EPSILON HCG TEST KIT MONOCLONAL K842654 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Oct 1984. https://www.510kdatabase.net/k843629/ 1984-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k843629-fetal-bovine-serum-f4884-sterile-growt-fda-510k.jpg K843629 - FETAL BOVINE SERUM, F4884 STERILE GROWT K843629 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Oct 1984. https://www.510kdatabase.net/k842755/ 1984-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k842755-titan-gel-iso-dot-cpk-procedure-fda-510k.jpg K842755 - TITAN GEL ISO DOT CPK PROCEDURE K842755 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Sep 1984. https://www.510kdatabase.net/k843508/ 1984-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k843508-emit-700-control-set-b-fda-510k.jpg K843508 - EMIT 700 CONTROL SET B K843508 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Sep 1984. https://www.510kdatabase.net/k843510/ 1984-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k843510-pda-cholesterol-fda-510k.jpg K843510 - PDA CHOLESTEROL K843510 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1984. https://www.510kdatabase.net/k843541/ 1984-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k843541-pda-glucose-fda-510k.jpg K843541 - PDA GLUCOSE K843541 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1984. https://www.510kdatabase.net/k843569/ 1984-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k843569-preciset-ammonia-fda-510k.jpg K843569 - PRECISET AMMONIA K843569 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Sep 1984. https://www.510kdatabase.net/k843645/ 1984-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k843645-systemate-a-amylase-hem-67204-fda-510k.jpg K843645 - SYSTEMATE A AMYLASE HEM 67204 K843645 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Sep 1984. https://www.510kdatabase.net/k843341/ 1984-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k843341-gono-pak-wthayer-martin-agargono-pak-fda-510k.jpg K843341 - GONO-PAK W/THAYER-MARTIN AGAR/GONO-PAK K843341 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1984. https://www.510kdatabase.net/k843509/ 1984-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k843509-emit-700-phencyclidine-assay-fda-510k.jpg K843509 - EMIT 700 PHENCYCLIDINE ASSAY K843509 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Sep 1984. https://www.510kdatabase.net/k843718/ 1984-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k843718-programmable-stimulator-5326-fda-510k.jpg K843718 - PROGRAMMABLE STIMULATOR 5326 K843718 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Sep 1984. https://www.510kdatabase.net/k842674/ 1984-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k842674-emit-dau-amphetamine-assay-fda-510k.jpg K842674 - EMIT D.A.U. AMPHETAMINE ASSAY K842674 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Sep 1984. https://www.510kdatabase.net/k842675/ 1984-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k842675-emit-dau-barbiturate-assay-fda-510k.jpg K842675 - EMIT D.A.U. BARBITURATE ASSAY K842675 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Sep 1984. https://www.510kdatabase.net/k842676/ 1984-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k842676-emit-dau-methadone-assay-fda-510k.jpg K842676 - EMIT D.A.U. METHADONE ASSAY K842676 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Sep 1984. https://www.510kdatabase.net/k842677/ 1984-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k842677-emit-dau-opiate-assay-fda-510k.jpg K842677 - EMIT D.A.U. OPIATE ASSAY K842677 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Sep 1984. https://www.510kdatabase.net/k842815/ 1984-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k842815-emit-dau-benzodiazepine-assay-fda-510k.jpg K842815 - EMIT D.A.U. BENZODIAZEPINE ASSAY K842815 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Sep 1984. https://www.510kdatabase.net/k843184/ 1984-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k843184-stratus-lidocaine-fluorometric-enzyme-fda-510k.jpg K843184 - STRATUS LIDOCAINE FLUOROMETRIC ENZYME K843184 is a FDA 510(k) cleared immunology medical device. Manufacturer: American Dade. Cleared Sep 1984. https://www.510kdatabase.net/k843420/ 1984-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k843420-emit-700-cannabinoid-calibrator-fda-510k.jpg K843420 - EMIT 700 CANNABINOID CALIBRATOR K843420 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Sep 1984. https://www.510kdatabase.net/k843507/ 1984-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k843507-emit-700-calibrator-b-fda-510k.jpg K843507 - EMIT 700 CALIBRATOR B K843507 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Sep 1984. https://www.510kdatabase.net/k843552/ 1984-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k843552-triglycerides-gpo-reagent-fda-510k.jpg K843552 - TRIGLYCERIDES GPO REAGENT K843552 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Sep 1984. https://www.510kdatabase.net/k842714/ 1984-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k842714-eeg-4300-woptinal-access-eeg-4314-fda-510k.jpg K842714 - EEG-4300 W/OPTINAL ACCESS. EEG 4314 & K842714 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Sep 1984. https://www.510kdatabase.net/k842897/ 1984-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k842897-medical-diag-ultrasound-instr-77065-fda-510k.jpg K842897 - MEDICAL DIAG. ULTRASOUND INSTR. 77065 K842897 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Sep 1984. https://www.510kdatabase.net/k843312/ 1984-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k843312-auto-suture-surgiclip-dispos-clip-appl-fda-510k.jpg K843312 - AUTO SUTURE SURGICLIP DISPOS. CLIP APPL K843312 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Sep 1984. https://www.510kdatabase.net/k843421/ 1984-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k843421-emit-700-cannabinoid-assay-fda-510k.jpg K843421 - EMIT 700 CANNABINOID ASSAY K843421 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Sep 1984. https://www.510kdatabase.net/k843393/ 1984-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k843393-lifeline-tle-476-04-fda-510k.jpg K843393 - LIFELINE TLE 476-04 K843393 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Sep 1984. https://www.510kdatabase.net/k843394/ 1984-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k843394-lifeline-tle-484-02-fda-510k.jpg K843394 - LIFELINE TLE 484-02 K843394 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Sep 1984. https://www.510kdatabase.net/k843328/ 1984-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k843328-systemate-t-bili-67212-fda-510k.jpg K843328 - SYSTEMATE T-BILI 67212 K843328 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Sep 1984. https://www.510kdatabase.net/k843329/ 1984-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k843329-systemate-d-bili-67213-fda-510k.jpg K843329 - SYSTEMATE D-BILI 67213 K843329 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Sep 1984. https://www.510kdatabase.net/k843333/ 1984-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k843333-systemate-got-67208-fda-510k.jpg K843333 - SYSTEMATE GOT 67208 K843333 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Sep 1984. https://www.510kdatabase.net/k843334/ 1984-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k843334-systemate-gpt-67209-fda-510k.jpg K843334 - SYSTEMATE GPT 67209 K843334 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Sep 1984. https://www.510kdatabase.net/k843458/ 1984-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k843458-emit-700-amphetamine-assay-new-product-fda-510k.jpg K843458 - EMIT 700 AMPHETAMINE ASSAY NEW PRODUCT K843458 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Sep 1984. https://www.510kdatabase.net/k842261/ 1984-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k842261-ob-ultrasound-linear-scanner-630-fda-510k.jpg K842261 - OB ULTRASOUND LINEAR SCANNER 630 K842261 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Sep 1984. https://www.510kdatabase.net/k834166/ 1984-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k834166-bard-co2-surgical-laser-sys-sls-50100-fda-510k.jpg K834166 - BARD CO2 SURGICAL LASER SYS SLS-50/100 K834166 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Sep 1984. https://www.510kdatabase.net/k843006/ 1984-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k843006-bard-parker-flatround-silicone-drain-fda-510k.jpg K843006 - BARD-PARKER FLAT/ROUND SILICONE DRAIN K843006 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1984. https://www.510kdatabase.net/k843034/ 1984-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k843034-disposable-linear-cutter-fda-510k.jpg K843034 - DISPOSABLE LINEAR CUTTER K843034 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Sep 1984. https://www.510kdatabase.net/k843183/ 1984-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k843183-stratus-cortisol-fluorometric-enzyme-fda-510k.jpg K843183 - STRATUS CORTISOL FLUOROMETRIC ENZYME K843183 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Sep 1984. https://www.510kdatabase.net/k843162/ 1984-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k843162-emit-700-opiate-assay-fda-510k.jpg K843162 - EMIT 700 OPIATE ASSAY K843162 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Sep 1984. https://www.510kdatabase.net/k843174/ 1984-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k843174-dri-stat-enzymatic-bilirubin-test-kit-fda-510k.jpg K843174 - DRI-STAT ENZYMATIC BILIRUBIN TEST KIT K843174 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Sep 1984. https://www.510kdatabase.net/k843193/ 1984-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k843193-strep-selective-ii-fda-510k.jpg K843193 - STREP SELECTIVE II K843193 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Sep 1984. https://www.510kdatabase.net/k843194/ 1984-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k843194-v-agar-selective-deeps-fda-510k.jpg K843194 - V AGAR SELECTIVE DEEPS K843194 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Sep 1984. https://www.510kdatabase.net/k843210/ 1984-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k843210-amikacin-calibrator-aca-fda-510k.jpg K843210 - AMIKACIN CALIBRATOR ACA K843210 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Sep 1984. https://www.510kdatabase.net/k843255/ 1984-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k843255-technicon-ra-1000-sys-iron-for-serum-fda-510k.jpg K843255 - TECHNICON RA-1000 SYS IRON FOR SERUM K843255 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Sep 1984. https://www.510kdatabase.net/k843326/ 1984-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k843326-systemate-bun-hem-no-67221-fda-510k.jpg K843326 - SYSTEMATE BUN HEM NO. 67221 K843326 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Sep 1984. https://www.510kdatabase.net/k843327/ 1984-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k843327-systemate-cholesterol-67222-fda-510k.jpg K843327 - SYSTEMATE CHOLESTEROL 67222 K843327 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Sep 1984. https://www.510kdatabase.net/k843330/ 1984-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k843330-systemate-phosphorus-67217-fda-510k.jpg K843330 - SYSTEMATE PHOSPHORUS 67217 K843330 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Sep 1984. https://www.510kdatabase.net/k843418/ 1984-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k843418-emit-700-barbiturate-assay-fda-510k.jpg K843418 - EMIT 700 BARBITURATE ASSAY K843418 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Sep 1984. https://www.510kdatabase.net/k843112/ 1984-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k843112-roche-standards-for-uric-acid-fda-510k.jpg K843112 - ROCHE STANDARDS FOR URIC ACID K843112 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Sep 1984. https://www.510kdatabase.net/k843265/ 1984-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k843265-id-zine-ld-isoenzyme-control-abnorm-fda-510k.jpg K843265 - ID ZINE LD ISOENZYME CONTROL ABNORM K843265 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Sep 1984. https://www.510kdatabase.net/k843266/ 1984-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k843266-id-zone-normal-ld-isoenzyme-control-fda-510k.jpg K843266 - ID ZONE NORMAL LD ISOENZYME CONTROL K843266 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Sep 1984. https://www.510kdatabase.net/k843268/ 1984-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k843268-systemate-2gt-67207-fda-510k.jpg K843268 - SYSTEMATE 2GT - 67207 K843268 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Sep 1984. https://www.510kdatabase.net/k843269/ 1984-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k843269-systemate-ldh-67210-fda-510k.jpg K843269 - SYSTEMATE LDH, 67210 K843269 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Sep 1984. https://www.510kdatabase.net/k843270/ 1984-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k843270-systemate-alkaline-phosphatase-67203-fda-510k.jpg K843270 - SYSTEMATE ALKALINE PHOSPHATASE-67203 K843270 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Sep 1984. https://www.510kdatabase.net/k843325/ 1984-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k843325-systemate-uric-acid-hem-67220-fda-510k.jpg K843325 - SYSTEMATE URIC ACID, HEM 67220 K843325 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Sep 1984. https://www.510kdatabase.net/k840937/ 1984-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k840937-capillary-flow-dialyzers-fda-510k.jpg K840937 - CAPILLARY FLOW DIALYZERS K840937 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Sep 1984. https://www.510kdatabase.net/k842344/ 1984-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k842344-hastings-bipolar-endoprosthesis-fda-510k.jpg K842344 - HASTINGS BIPOLAR ENDOPROSTHESIS K842344 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Sep 1984. https://www.510kdatabase.net/k842366/ 1984-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k842366-oxalate-urine-controls-normal-elevat-fda-510k.jpg K842366 - OXALATE URINE CONTROLS NORMAL & ELEVAT K842366 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Sep 1984. https://www.510kdatabase.net/k843163/ 1984-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k843163-emit-700-calibrator-a-fda-510k.jpg K843163 - EMIT 700 CALIBRATOR A K843163 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Sep 1984. https://www.510kdatabase.net/k843211/ 1984-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k843211-amikacin-analytical-test-pack-aca-fda-510k.jpg K843211 - AMIKACIN ANALYTICAL TEST PACK ACA K843211 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Sep 1984. https://www.510kdatabase.net/k843237/ 1984-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k843237-stratus-quinidine-fluorometric-enzyme-fda-510k.jpg K843237 - STRATUS QUINIDINE FLUOROMETRIC ENZYME K843237 is a FDA 510(k) cleared toxicology medical device. Manufacturer: American Dade. Cleared Sep 1984. https://www.510kdatabase.net/k842343/ 1984-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k842343-saba-coombs-mini-external-fixator-fda-510k.jpg K842343 - SABA-COOMBS MINI EXTERNAL FIXATOR K842343 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Sep 1984. https://www.510kdatabase.net/k841520/ 1984-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k841520-cmv-latex-agglutination-test-kit-fda-510k.jpg K841520 - CMV LATEX AGGLUTINATION TEST KIT K841520 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1984. https://www.510kdatabase.net/k842684/ 1984-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k842684-diatrol-blood-glucose-test-sys-fda-510k.jpg K842684 - DIATROL BLOOD GLUCOSE TEST SYS K842684 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1984. https://www.510kdatabase.net/k842694/ 1984-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k842694-terumo-sensibead-eia-thyroid-uptake-kit-fda-510k.jpg K842694 - TERUMO SENSIBEAD EIA THYROID UPTAKE KIT K842694 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Terumo Medical Corp.. Cleared Sep 1984. https://www.510kdatabase.net/k842783/ 1984-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k842783-aca-barbiturates-screen-analy-test-pack-fda-510k.jpg K842783 - ACA BARBITURATES SCREEN ANALY TEST PACK K842783 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Sep 1984. https://www.510kdatabase.net/k843271/ 1984-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k843271-systemate-ck-total-67206-fda-510k.jpg K843271 - SYSTEMATE CK-TOTAL - 67206 K843271 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Sep 1984. https://www.510kdatabase.net/k841736/ 1984-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k841736-il-test-antithrombin-iii-activity-fda-510k.jpg K841736 - IL TEST ANTITHROMBIN III ACTIVITY K841736 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 1984. https://www.510kdatabase.net/k842816/ 1984-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k842816-emit-dau-low-med-calibrators-b-fda-510k.jpg K842816 - EMIT D.A.U. LOW & MED. CALIBRATORS B K842816 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Sep 1984. https://www.510kdatabase.net/k843192/ 1984-09-05 monthly 0.5 https://www.510kdatabase.net/og-image/k843192-apr-mobile-fda-510k.jpg K843192 - APR MOBILE K843192 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Sep 1984. https://www.510kdatabase.net/k841997/ 1984-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k841997-ct-9800-fda-510k.jpg K841997 - CT 9800 K841997 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Sep 1984. https://www.510kdatabase.net/k843110/ 1984-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k843110-roche-standards-for-cholesterol-fda-510k.jpg K843110 - ROCHE STANDARDS FOR CHOLESTEROL K843110 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Sep 1984. https://www.510kdatabase.net/k841517/ 1984-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k841517-cloutier-ii-total-knee-wbeaded-surf-fda-510k.jpg K841517 - CLOUTIER II TOTAL KNEE W/BEADED SURF K841517 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Aug 1984. https://www.510kdatabase.net/k842713/ 1984-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k842713-tdx-disopyramide-fda-510k.jpg K842713 - TDX DISOPYRAMIDE K842713 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1984. https://www.510kdatabase.net/k843087/ 1984-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k843087-universal-2-s-centrifuge-fda-510k.jpg K843087 - UNIVERSAL 2 S CENTRIFUGE K843087 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Aug 1984. https://www.510kdatabase.net/k843088/ 1984-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k843088-eba-3-s-centrifuge-fda-510k.jpg K843088 - EBA 3 S CENTRIFUGE K843088 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Aug 1984. https://www.510kdatabase.net/k843089/ 1984-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k843089-medtronic-84378438-fda-510k.jpg K843089 - MEDTRONIC 8437/8438 K843089 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Aug 1984. https://www.510kdatabase.net/k843152/ 1984-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k843152-systemate-calcium-67214-fda-510k.jpg K843152 - SYSTEMATE CALCIUM 67214 K843152 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Aug 1984. https://www.510kdatabase.net/k843160/ 1984-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k843160-emit-700-cocaine-metabolite-assay-fda-510k.jpg K843160 - EMIT 700 COCAINE METABOLITE ASSAY K843160 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Aug 1984. https://www.510kdatabase.net/k843161/ 1984-08-29 monthly 0.5 https://www.510kdatabase.net/og-image/k843161-emit-700-control-set-a-fda-510k.jpg K843161 - EMIT 700 CONTROL SET A K843161 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Aug 1984. https://www.510kdatabase.net/k841499/ 1984-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k841499-lifescope-ii-fda-510k.jpg K841499 - LIFESCOPE II K841499 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Aug 1984. https://www.510kdatabase.net/k841500/ 1984-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k841500-lifescope-6-oec-6201-fda-510k.jpg K841500 - LIFESCOPE 6 OEC-6201 K841500 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Aug 1984. https://www.510kdatabase.net/k841501/ 1984-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k841501-lifescope-6-oec-6102-fda-510k.jpg K841501 - LIFESCOPE 6 OEC-6102 K841501 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Aug 1984. https://www.510kdatabase.net/k841502/ 1984-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k841502-lifescope-6-oec-6105-fda-510k.jpg K841502 - LIFESCOPE 6 OEC-6105 K841502 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Aug 1984. https://www.510kdatabase.net/k842468/ 1984-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k842468-tissue-tek-immunohistology-kit-igaigg-fda-510k.jpg K842468 - TISSUE-TEK IMMUNOHISTOLOGY KIT IGA/IGG K842468 is a FDA 510(k) cleared immunology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Aug 1984. https://www.510kdatabase.net/k842470/ 1984-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k842470-tissue-tek-immunohistology-kit-lysozzm-fda-510k.jpg K842470 - TISSUE-TEK IMMUNOHISTOLOGY KIT LYSOZZM K842470 is a FDA 510(k) cleared immunology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Aug 1984. https://www.510kdatabase.net/k843085/ 1984-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k843085-rpmi-1640-medium-r3505-what-l-gluta-fda-510k.jpg K843085 - RPMI-1640 MEDIUM #R3505 W/HAT, L-GLUTA K843085 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sigma Chemical Co.. Cleared Aug 1984. https://www.510kdatabase.net/k843086/ 1984-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k843086-dulbeccos-modified-eagles-nutirent-mix-fda-510k.jpg K843086 - DULBECCO'S MODIFIED EAGLE'S NUTIRENT MIX K843086 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sigma Chemical Co.. Cleared Aug 1984. https://www.510kdatabase.net/k842889/ 1984-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k842889-argyle-custom-tubing-pack-fda-510k.jpg K842889 - ARGYLE CUSTOM TUBING PACK K842889 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sherwood Medical Co.. Cleared Aug 1984. https://www.510kdatabase.net/k843105/ 1984-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k843105-systemate-creatinine-67223-fda-510k.jpg K843105 - SYSTEMATE CREATININE 67223 K843105 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Aug 1984. https://www.510kdatabase.net/k843106/ 1984-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k843106-systemate-triglyceride-67219-fda-510k.jpg K843106 - SYSTEMATE TRIGLYCERIDE 67219 K843106 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Aug 1984. https://www.510kdatabase.net/k843107/ 1984-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k843107-systemate-total-protein-67218-fda-510k.jpg K843107 - SYSTEMATE TOTAL PROTEIN 67218 K843107 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Aug 1984. https://www.510kdatabase.net/k843108/ 1984-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k843108-systemate-albumin-fda-510k.jpg K843108 - SYSTEMATE ALBUMIN K843108 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Aug 1984. https://www.510kdatabase.net/k843148/ 1984-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k843148-kodak-t-mat-h-film-so-118-fda-510k.jpg K843148 - KODAK T-MAT H FILM SO-118 K843148 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Eastman Kodak Company. Cleared Aug 1984. https://www.510kdatabase.net/k843149/ 1984-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k843149-kodak-t-mat-c-film-so-119-fda-510k.jpg K843149 - KODAK T-MAT C FILM SO-119 K843149 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Aug 1984. https://www.510kdatabase.net/k843150/ 1984-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k843150-systemate-glucose-67216-fda-510k.jpg K843150 - SYSTEMATE GLUCOSE 67216 K843150 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Aug 1984. https://www.510kdatabase.net/k843151/ 1984-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k843151-systemate-glucose-67215-fda-510k.jpg K843151 - SYSTEMATE GLUCOSE 67215 K843151 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Aug 1984. https://www.510kdatabase.net/k843176/ 1984-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k843176-kodak-x-omatic-radiation-therapy-cass-fda-510k.jpg K843176 - KODAK X-OMATIC RADIATION THERAPY CASS K843176 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Aug 1984. https://www.510kdatabase.net/k841041/ 1984-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k841041-clini-tek-auto-2000-reflectance-spectr-fda-510k.jpg K841041 - CLINI-TEK AUTO 2000 REFLECTANCE SPECTR K841041 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Aug 1984. https://www.510kdatabase.net/k842055/ 1984-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k842055-picker-artis-ultrasound-imaging-sys-fda-510k.jpg K842055 - PICKER ARTIS ULTRASOUND IMAGING SYS K842055 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Aug 1984. https://www.510kdatabase.net/k842906/ 1984-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k842906-bias-total-hip-fda-510k.jpg K842906 - BIAS TOTAL HIP K842906 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Aug 1984. https://www.510kdatabase.net/k843155/ 1984-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k843155-sure-natural-deodorant-maxi-shield-fda-510k.jpg K843155 - SURE & NATURAL DEODORANT MAXI-SHIELD K843155 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Aug 1984. https://www.510kdatabase.net/k840140/ 1984-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k840140-doppler-imaging-option-fda-510k.jpg K840140 - DOPPLER IMAGING OPTION K840140 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Aug 1984. https://www.510kdatabase.net/k842253/ 1984-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k842253-augmentin-30-mcg-sensi-disc-fda-510k.jpg K842253 - AUGMENTIN 30 MCG SENSI DISC K842253 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1984. https://www.510kdatabase.net/k843262/ 1984-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k843262-transesophageal-echocardiography-ultraso-fda-510k.jpg K843262 - TRANSESOPHAGEAL ECHOCARDIOGRAPHY ULTRASO K843262 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Aug 1984. https://www.510kdatabase.net/k842891/ 1984-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k842891-qca-triglycerides-fda-510k.jpg K842891 - QCA TRIGLYCERIDES K842891 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1984. https://www.510kdatabase.net/k842776/ 1984-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k842776-minimum-essential-med-wl-glutamine-fda-510k.jpg K842776 - MINIMUM ESSENTIAL MED W/L-GLUTAMINE K842776 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sigma Chemical Co.. Cleared Aug 1984. https://www.510kdatabase.net/k842337/ 1984-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k842337-shiley-venous-reservoir-fda-510k.jpg K842337 - SHILEY VENOUS RESERVOIR K842337 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Aug 1984. https://www.510kdatabase.net/k842348/ 1984-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k842348-spx-generator-fda-510k.jpg K842348 - SPX GENERATOR K842348 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Aug 1984. https://www.510kdatabase.net/k842367/ 1984-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k842367-howmedica-kinematic-ii-tibial-wedge-fda-510k.jpg K842367 - HOWMEDICA KINEMATIC II TIBIAL WEDGE K842367 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Aug 1984. https://www.510kdatabase.net/k842385/ 1984-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k842385-aca-conjugated-bilirubin-analytical-fda-510k.jpg K842385 - ACA CONJUGATED BILIRUBIN ANALYTICAL K842385 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Aug 1984. https://www.510kdatabase.net/k842421/ 1984-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k842421-argyle-enterite-enteral-feeding-pump-fda-510k.jpg K842421 - ARGYLE ENTERITE ENTERAL FEEDING PUMP K842421 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Aug 1984. https://www.510kdatabase.net/k842552/ 1984-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k842552-coat-a-count-dhea-so4-ria-kit-fda-510k.jpg K842552 - COAT-A-COUNT DHEA-SO4 RIA KIT K842552 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Aug 1984. https://www.510kdatabase.net/k842592/ 1984-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k842592-ames-tda-phenobarbital-test-fda-510k.jpg K842592 - AMES TDA PHENOBARBITAL TEST K842592 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Aug 1984. https://www.510kdatabase.net/k842606/ 1984-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k842606-coat-a-count-dhea-ria-kit-fda-510k.jpg K842606 - COAT-A-COUNT DHEA RIA KIT K842606 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Aug 1984. https://www.510kdatabase.net/k842775/ 1984-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k842775-min-essential-med-wl-glutamine-rib-fda-510k.jpg K842775 - MIN. ESSENTIAL MED. W/L-GLUTAMINE, RIB K842775 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Sigma Chemical Co.. Cleared Aug 1984. https://www.510kdatabase.net/k842809/ 1984-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k842809-technicon-ra-1000-sys-direct-bilirubin-fda-510k.jpg K842809 - TECHNICON RA-1000 SYS, DIRECT BILIRUBIN K842809 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Aug 1984. https://www.510kdatabase.net/k840845/ 1984-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k840845-hollow-fiber-dialyzers-fda-510k.jpg K840845 - HOLLOW FIBER DIALYZERS K840845 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Aug 1984. https://www.510kdatabase.net/k842280/ 1984-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k842280-tdx-digitoxin-fda-510k.jpg K842280 - TDX DIGITOXIN K842280 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1984. https://www.510kdatabase.net/k842365/ 1984-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k842365-corti-cote-cortisol-solid-phase-radio-fda-510k.jpg K842365 - CORTI-COTE CORTISOL SOLID PHASE RADIO K842365 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1984. https://www.510kdatabase.net/k842393/ 1984-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k842393-boehringer-mannheim-diag-blood-glucose-fda-510k.jpg K842393 - BOEHRINGER MANNHEIM DIAG. BLOOD GLUCOSE K842393 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Aug 1984. https://www.510kdatabase.net/k842548/ 1984-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k842548-aca-acetaminophen-analytical-test-pack-fda-510k.jpg K842548 - ACA ACETAMINOPHEN ANALYTICAL TEST PACK K842548 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Aug 1984. https://www.510kdatabase.net/k842549/ 1984-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k842549-aca-acetaminophen-calibrator-fda-510k.jpg K842549 - ACA ACETAMINOPHEN CALIBRATOR K842549 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Aug 1984. https://www.510kdatabase.net/k842655/ 1984-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k842655-epsilon-digoxin-test-kit-fda-510k.jpg K842655 - EPSILON DIGOXIN TEST KIT K842655 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Aug 1984. https://www.510kdatabase.net/k842237/ 1984-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k842237-clinitek-200-semi-automated-urinalysis-fda-510k.jpg K842237 - CLINITEK 200 SEMI-AUTOMATED URINALYSIS K842237 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Aug 1984. https://www.510kdatabase.net/k842320/ 1984-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k842320-tdx-rea-cholesterol-fda-510k.jpg K842320 - TDX REA CHOLESTEROL K842320 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1984. https://www.510kdatabase.net/k842386/ 1984-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k842386-aca-barbiturates-screenbenzodiazepin-fda-510k.jpg K842386 - ACA BARBITURATES SCREEN/BENZODIAZEPIN K842386 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Aug 1984. https://www.510kdatabase.net/k842387/ 1984-08-15 monthly 0.5 https://www.510kdatabase.net/og-image/k842387-aca-benzodiazepines-screen-test-pk-fda-510k.jpg K842387 - ACA BENZODIAZEPINES SCREEN TEST PK K842387 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Aug 1984. https://www.510kdatabase.net/k841547/ 1984-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k841547-hemoclip-ligating-clips-medsml-fda-510k.jpg K841547 - HEMOCLIP LIGATING CLIPS MED/SML K841547 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Aug 1984. https://www.510kdatabase.net/k841548/ 1984-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k841548-hemoclip-ligating-clips-mlarge-fda-510k.jpg K841548 - HEMOCLIP LIGATING CLIPS M/LARGE K841548 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Aug 1984. https://www.510kdatabase.net/k841549/ 1984-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k841549-hemoclip-automatic-clips-medium-fda-510k.jpg K841549 - HEMOCLIP AUTOMATIC CLIPS MEDIUM K841549 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Aug 1984. https://www.510kdatabase.net/k843043/ 1984-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k843043-med-199-catalog-m3769-wearles-salt-fda-510k.jpg K843043 - MED. 199 CATALOG M3769 W/EARLE'S SALT K843043 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Aug 1984. https://www.510kdatabase.net/k843044/ 1984-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k843044-minim-essential-med-eagle-m4144-w-fda-510k.jpg K843044 - MINIM. ESSENTIAL MED. EAGLE M4144 W/ K843044 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Aug 1984. https://www.510kdatabase.net/k842411/ 1984-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k842411-sigma-58-uv-aspartate-aminotransferas-fda-510k.jpg K842411 - SIGMA 58-UV ASPARTATE AMINOTRANSFERAS K842411 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Aug 1984. https://www.510kdatabase.net/k842564/ 1984-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k842564-sigma-59-uv-for-alanine-aminotransfer-fda-510k.jpg K842564 - SIGMA 59-UV FOR ALANINE AMINOTRANSFER K842564 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Aug 1984. https://www.510kdatabase.net/k842578/ 1984-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k842578-sopheiamp-digitoxin-eia-kit-fda-510k.jpg K842578 - SOPHEIA/MP DIGITOXIN EIA KIT K842578 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Aug 1984. https://www.510kdatabase.net/k842673/ 1984-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k842673-emit-low-medium-calibrators-a-fda-510k.jpg K842673 - EMIT LOW & MEDIUM CALIBRATORS A K842673 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Aug 1984. https://www.510kdatabase.net/k843045/ 1984-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k843045-lactalbumin-hydrolysate-med-catalog-fda-510k.jpg K843045 - LACTALBUMIN HYDROLYSATE MED. CATALOG K843045 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Aug 1984. https://www.510kdatabase.net/k840903/ 1984-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k840903-helena-coloscreen-self-test-fda-510k.jpg K840903 - HELENA COLOSCREEN SELF-TEST K840903 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Aug 1984. https://www.510kdatabase.net/k841797/ 1984-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k841797-multipro-catheter-fda-510k.jpg K841797 - MULTIPRO CATHETER K841797 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Aug 1984. https://www.510kdatabase.net/k842382/ 1984-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k842382-3m-rapidstat-ligating-clip-sys-fda-510k.jpg K842382 - 3M RAPIDSTAT LIGATING CLIP SYS K842382 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3M Company. Cleared Aug 1984. https://www.510kdatabase.net/k842588/ 1984-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k842588-simultropin-radioimmunoassay-kit-lh-fda-510k.jpg K842588 - SIMULTROPIN RADIOIMMUNOASSAY KIT LH K842588 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1984. https://www.510kdatabase.net/k842693/ 1984-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k842693-respironics-venteasy-fda-510k.jpg K842693 - RESPIRONICS VENTEASY K842693 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Aug 1984. https://www.510kdatabase.net/k842711/ 1984-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k842711-shiley-cardiotomy-reservoir-wfilter-fda-510k.jpg K842711 - SHILEY CARDIOTOMY RESERVOIR W/FILTER K842711 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Aug 1984. https://www.510kdatabase.net/k842505/ 1984-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k842505-tdx-rea-iron-diagnostic-kit-fda-510k.jpg K842505 - TDX REA IRON DIAGNOSTIC KIT K842505 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1984. https://www.510kdatabase.net/k840198/ 1984-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k840198-arterial-embolectomy-catheter-fda-510k.jpg K840198 - ARTERIAL EMBOLECTOMY CATHETER K840198 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Aug 1984. https://www.510kdatabase.net/k842780/ 1984-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k842780-medtronic-6210-permanent-lead-introduc-fda-510k.jpg K842780 - MEDTRONIC 6210 PERMANENT LEAD INTRODUC K842780 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Aug 1984. https://www.510kdatabase.net/k840652/ 1984-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k840652-prism-fine-fda-510k.jpg K840652 - PRISM-FINE K840652 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Aug 1984. https://www.510kdatabase.net/k841362/ 1984-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k841362-tidal-distension-irrigation-set-fda-510k.jpg K841362 - TIDAL DISTENSION IRRIGATION SET K841362 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1984. https://www.510kdatabase.net/k841611/ 1984-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k841611-quinton-901-900-holter-scanner-fda-510k.jpg K841611 - QUINTON 901 & 900 HOLTER SCANNER K841611 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Aug 1984. https://www.510kdatabase.net/k842522/ 1984-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k842522-pda-system-fda-510k.jpg K842522 - PDA SYSTEM K842522 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1984. https://www.510kdatabase.net/k842551/ 1984-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k842551-base-metal-alloy-fda-510k.jpg K842551 - BASE METAL ALLOY K842551 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Aug 1984. https://www.510kdatabase.net/k842623/ 1984-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k842623-microtrak-chlamydia-trachomatis-direct-fda-510k.jpg K842623 - MICROTRAK CHLAMYDIA TRACHOMATIS DIRECT K842623 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Syva Co.. Cleared Aug 1984. https://www.510kdatabase.net/k832290/ 1984-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k832290-cystoflo-antimicrobial-urinary-drainage-fda-510k.jpg K832290 - CYSTOFLO ANTIMICROBIAL URINARY DRAINAGE K832290 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Jul 1984. https://www.510kdatabase.net/k842109/ 1984-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k842109-technicon-test-point-assayed-hematology-fda-510k.jpg K842109 - TECHNICON TEST POINT ASSAYED HEMATOLOGY K842109 is a FDA 510(k) cleared hematology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Jul 1984. https://www.510kdatabase.net/k842146/ 1984-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k842146-histopaque-1077-fda-510k.jpg K842146 - HISTOPAQUE-1077 K842146 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Chemical Co.. Cleared Jul 1984. https://www.510kdatabase.net/k842605/ 1984-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k842605-respironics-vent-easy-oxygen-enrichme-fda-510k.jpg K842605 - RESPIRONICS VENT EASY OXYGEN ENRICHME K842605 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Jul 1984. https://www.510kdatabase.net/k842636/ 1984-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k842636-technicon-h1-system-fda-510k.jpg K842636 - TECHNICON H*1 SYSTEM K842636 is a FDA 510(k) cleared hematology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Jul 1984. https://www.510kdatabase.net/k842774/ 1984-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k842774-codman-suction-punch-product-codes-fda-510k.jpg K842774 - CODMAN SUCTION PUNCH-PRODUCT CODES K842774 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Jul 1984. https://www.510kdatabase.net/k841789/ 1984-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k841789-sechrist-air-oxygen-mixer-ancillary-fda-510k.jpg K841789 - SECHRIST AIR-OXYGEN MIXER & ANCILLARY K841789 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shiley, Inc.. Cleared Jul 1984. https://www.510kdatabase.net/k842392/ 1984-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k842392-delton-opaque-light-curing-pit-fda-510k.jpg K842392 - DELTON * OPAQUE LIGHT CURING PIT K842392 is a FDA 510(k) cleared dental medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jul 1984. https://www.510kdatabase.net/k842238/ 1984-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k842238-clinitek-10-semi-auto-urinalysis-sys-fda-510k.jpg K842238 - CLINITEK 10 SEMI-AUTO URINALYSIS SYS K842238 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Jul 1984. https://www.510kdatabase.net/k842390/ 1984-07-25 monthly 0.5 https://www.510kdatabase.net/og-image/k842390-syva-iq-190-digital-pipetter-diluter-fda-510k.jpg K842390 - SYVA IQ 190 DIGITAL PIPETTER DILUTER K842390 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jul 1984. https://www.510kdatabase.net/k842252/ 1984-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k842252-cefonicid-30-mcg-sensi-disc-fda-510k.jpg K842252 - CEFONICID 30 MCG SENSI-DISC K842252 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jul 1984. https://www.510kdatabase.net/k842279/ 1984-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k842279-bectec-nr-660-bacterial-detect-sys-fda-510k.jpg K842279 - BECTEC NR-660 BACTERIAL DETECT SYS K842279 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jul 1984. https://www.510kdatabase.net/k842671/ 1984-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k842671-basal-med-eagle-b8265-wearls-salts-fda-510k.jpg K842671 - BASAL MED. EAGLE B8265, W/EARLS SALTS K842671 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Jul 1984. https://www.510kdatabase.net/k842672/ 1984-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k842672-minimum-essential-med-m0769-wwo-fda-510k.jpg K842672 - MINIMUM ESSENTIAL MED. M0769 W/WO K842672 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Jul 1984. https://www.510kdatabase.net/k841740/ 1984-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k841740-terumo-digital-clinical-thermometer-fda-510k.jpg K841740 - TERUMO DIGITAL CLINICAL THERMOMETER K841740 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terumo Medical Corp.. Cleared Jul 1984. https://www.510kdatabase.net/k842080/ 1984-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k842080-abbott-lifecare-1050-controller-fda-510k.jpg K842080 - ABBOTT LIFECARE 1050 CONTROLLER K842080 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Jul 1984. https://www.510kdatabase.net/k842184/ 1984-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k842184-spot-film-device-8835-fda-510k.jpg K842184 - SPOT-FILM DEVICE 8835 K842184 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jul 1984. https://www.510kdatabase.net/k841996/ 1984-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k841996-maxicamera-400t-wbody-contour-tomogra-fda-510k.jpg K841996 - MAXICAMERA 400T W/BODY CONTOUR TOMOGRA K841996 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jul 1984. https://www.510kdatabase.net/k842006/ 1984-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k842006-citoject-cartridge-syringe-fda-510k.jpg K842006 - CITOJECT CARTRIDGE SYRINGE K842006 is a FDA 510(k) cleared dental medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Jul 1984. https://www.510kdatabase.net/k841878/ 1984-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k841878-sheath-remover-fda-510k.jpg K841878 - SHEATH REMOVER K841878 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Datascope Corp.. Cleared Jul 1984. https://www.510kdatabase.net/k842176/ 1984-07-13 monthly 0.5 https://www.510kdatabase.net/og-image/k842176-raaf-dual-lumen-catheter-fda-510k.jpg K842176 - RAAF DUAL LUMEN CATHETER K842176 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Jul 1984. https://www.510kdatabase.net/k842078/ 1984-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k842078-johnson-johnson-flavored-etching-gel-fda-510k.jpg K842078 - JOHNSON & JOHNSON FLAVORED ETCHING GEL K842078 is a FDA 510(k) cleared dental medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jul 1984. https://www.510kdatabase.net/k842042/ 1984-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k842042-il-1312-ph-blood-gas-manager-fda-510k.jpg K842042 - IL 1312, PH BLOOD GAS MANAGER K842042 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jul 1984. https://www.510kdatabase.net/k842196/ 1984-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k842196-stratus-primidone-florometric-enzy-fda-510k.jpg K842196 - STRATUS PRIMIDONE FLOROMETRIC ENZY K842196 is a FDA 510(k) cleared toxicology medical device. Manufacturer: American Dade. Cleared Jul 1984. https://www.510kdatabase.net/k842523/ 1984-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k842523-bird-heated-humidifier-3201-fda-510k.jpg K842523 - BIRD HEATED HUMIDIFIER 3201 K842523 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: 3M Company. Cleared Jul 1984. https://www.510kdatabase.net/k842685/ 1984-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k842685-becton-dickinson-1000-insulin-pump-fda-510k.jpg K842685 - BECTON DICKINSON 1000 INSULIN PUMP K842685 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jul 1984. https://www.510kdatabase.net/k841043/ 1984-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k841043-behring-elisa-processor-m-fda-510k.jpg K841043 - BEHRING ELISA PROCESSOR M K841043 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Jul 1984. https://www.510kdatabase.net/k841884/ 1984-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k841884-kodak-ektachem-control-fda-510k.jpg K841884 - KODAK EKTACHEM CONTROL K841884 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Jul 1984. https://www.510kdatabase.net/k841906/ 1984-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k841906-maxicamera-400-ac-fda-510k.jpg K841906 - MAXICAMERA 400 AC K841906 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jul 1984. https://www.510kdatabase.net/k842211/ 1984-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k842211-ultra-chem-enzymatic-triglyceride-fda-510k.jpg K842211 - ULTRA CHEM ENZYMATIC TRIGLYCERIDE K842211 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared Jul 1984. https://www.510kdatabase.net/k841647/ 1984-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k841647-neuromedics-ultrastim-650-01-fda-510k.jpg K841647 - NEUROMEDICS ULTRASTIM 650-01 K841647 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Intermedics, Inc.. Cleared Jul 1984. https://www.510kdatabase.net/k842480/ 1984-07-03 monthly 0.5 https://www.510kdatabase.net/og-image/k842480-sure-natural-maxi-shield-fda-510k.jpg K842480 - SURE & NATURAL MAXI-SHIELD K842480 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jul 1984. https://www.510kdatabase.net/k841484/ 1984-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k841484-sterile-or-basin-kit-product-line-fda-510k.jpg K841484 - STERILE O.R. BASIN KIT PRODUCT LINE K841484 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Jul 1984. https://www.510kdatabase.net/k841995/ 1984-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k841995-105-french-dilator-15cm-wluer-lock-fda-510k.jpg K841995 - 10.5 FRENCH DILATOR, 15CM, W/LUER LOCK K841995 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Jul 1984. https://www.510kdatabase.net/k842383/ 1984-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k842383-patho-dx-latex-agglutination-strep-a-fda-510k.jpg K842383 - PATHO DX LATEX AGGLUTINATION STREP A K842383 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jul 1984. https://www.510kdatabase.net/k840877/ 1984-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k840877-argyle-enternal-feeding-bag-wadmin-fda-510k.jpg K840877 - ARGYLE ENTERNAL FEEDING BAG W/ADMIN K840877 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Jun 1984. https://www.510kdatabase.net/k842053/ 1984-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k842053-paraplast-extra-tissue-embedding-med-fda-510k.jpg K842053 - PARAPLAST EXTRA TISSUE EMBEDDING MED. K842053 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sherwood Medical Co.. Cleared Jun 1984. https://www.510kdatabase.net/k841437/ 1984-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k841437-pennsylvania-hospital-hip-sys-fda-510k.jpg K841437 - PENNSYLVANIA HOSPITAL HIP SYS K841437 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jun 1984. https://www.510kdatabase.net/k841955/ 1984-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k841955-dupont-aca-magnesium-calibrator-fda-510k.jpg K841955 - DUPONT ACA MAGNESIUM CALIBRATOR K841955 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Jun 1984. https://www.510kdatabase.net/k842013/ 1984-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k842013-sigma-procedure-47-uv-fda-510k.jpg K842013 - SIGMA PROCEDURE 47-UV K842013 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Jun 1984. https://www.510kdatabase.net/k834457/ 1984-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k834457-emit-dau-urine-cannabinoid-calibra-fda-510k.jpg K834457 - EMIT D.A.U. URINE CANNABINOID CALIBRA K834457 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jun 1984. https://www.510kdatabase.net/k840962/ 1984-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k840962-reflocheck-s-fda-510k.jpg K840962 - REFLOCHECK-S K840962 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jun 1984. https://www.510kdatabase.net/k841550/ 1984-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k841550-scotchbond-light-cured-dental-adhes-fda-510k.jpg K841550 - SCOTCHBOND LIGHT CURED DENTAL ADHES K841550 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Jun 1984. https://www.510kdatabase.net/k841776/ 1984-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k841776-ana-sensitivityspecificity-control-fda-510k.jpg K841776 - ANA SENSITIVITY/SPECIFICITY CONTROL K841776 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Jun 1984. https://www.510kdatabase.net/k841814/ 1984-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k841814-optimate-igm-test-fda-510k.jpg K841814 - OPTIMATE IGM TEST K841814 is a FDA 510(k) cleared immunology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Jun 1984. https://www.510kdatabase.net/k841816/ 1984-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k841816-optimate-igg-test-fda-510k.jpg K841816 - OPTIMATE IGG TEST K841816 is a FDA 510(k) cleared immunology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Jun 1984. https://www.510kdatabase.net/k841821/ 1984-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k841821-ca-1511-in-vitro-radioimmunoassay-fda-510k.jpg K841821 - CA-1511, IN VITRO RADIOIMMUNOASSAY K841821 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Jun 1984. https://www.510kdatabase.net/k841886/ 1984-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k841886-paramax-iron-reagent-fda-510k.jpg K841886 - PARAMAX IRON REAGENT K841886 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Jun 1984. https://www.510kdatabase.net/k841887/ 1984-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k841887-paramax-iron-blank-reagent-fda-510k.jpg K841887 - PARAMAX IRON BLANK REAGENT K841887 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Jun 1984. https://www.510kdatabase.net/k841916/ 1984-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k841916-abbott-project-i-fda-510k.jpg K841916 - ABBOTT PROJECT I K841916 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1984. https://www.510kdatabase.net/k842002/ 1984-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k842002-hanks-balanced-salts-hbss-h2387-fda-510k.jpg K842002 - HANKS BALANCED SALTS-HBSS H2387 K842002 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Jun 1984. https://www.510kdatabase.net/k842019/ 1984-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k842019-tibc-pretreatment-kit-fda-510k.jpg K842019 - TIBC PRETREATMENT KIT K842019 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Jun 1984. https://www.510kdatabase.net/k842297/ 1984-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k842297-arginie-broth-fda-510k.jpg K842297 - ARGINIE BROTH K842297 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Jun 1984. https://www.510kdatabase.net/k834458/ 1984-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k834458-emit-dau-urine-cannabinoid-assay-fda-510k.jpg K834458 - EMIT D.A.U. URINE CANNABINOID ASSAY K834458 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jun 1984. https://www.510kdatabase.net/k841238/ 1984-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k841238-emit-st-urine-cannabinoid-assay-fda-510k.jpg K841238 - EMIT ST URINE CANNABINOID ASSAY K841238 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jun 1984. https://www.510kdatabase.net/k840955/ 1984-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k840955-condylar-prosthesis-of-mandible-whead-fda-510k.jpg K840955 - CONDYLAR PROSTHESIS OF MANDIBLE W/HEAD K840955 is a FDA 510(k) cleared dental medical device. Manufacturer: Synthes (Usa). Cleared Jun 1984. https://www.510kdatabase.net/k841191/ 1984-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k841191-microtrakspeciman-id-typing-test-contr-fda-510k.jpg K841191 - MICROTRAKSPECIMAN ID TYPING TEST CONTR K841191 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Syva Co.. Cleared Jun 1984. https://www.510kdatabase.net/k841917/ 1984-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k841917-sigms-proced-228-uv-lactate-dehydro-fda-510k.jpg K841917 - SIGMS PROCED. 228 UV LACTATE DEHYDRO K841917 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Jun 1984. https://www.510kdatabase.net/k841918/ 1984-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k841918-sigma-proced-245-alkaline-phosphatase-fda-510k.jpg K841918 - SIGMA PROCED. 245 ALKALINE PHOSPHATASE K841918 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Diagnostics, Inc.. Cleared Jun 1984. https://www.510kdatabase.net/k841703/ 1984-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k841703-tdx-rea-ldh-fda-510k.jpg K841703 - TDX REA LDH K841703 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1984. https://www.510kdatabase.net/k841497/ 1984-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k841497-neuropack-8-mee-4108-fda-510k.jpg K841497 - NEUROPACK 8 MEE 4108 K841497 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Jun 1984. https://www.510kdatabase.net/k841612/ 1984-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k841612-neuropack-ii-5100-fda-510k.jpg K841612 - NEUROPACK II 5100 K841612 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Jun 1984. https://www.510kdatabase.net/k841784/ 1984-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k841784-flexiflo-iii-portable-enteral-nutri-fda-510k.jpg K841784 - FLEXIFLO-III PORTABLE ENTERAL NUTRI K841784 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1984. https://www.510kdatabase.net/k842100/ 1984-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k842100-macconkey-agar-plus-fda-510k.jpg K842100 - MACCONKEY AGAR, PLUS K842100 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Jun 1984. https://www.510kdatabase.net/k842101/ 1984-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k842101-coba-agar-fda-510k.jpg K842101 - COBA AGAR K842101 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Jun 1984. https://www.510kdatabase.net/k834211/ 1984-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k834211-leap-frog-fda-510k.jpg K834211 - LEAP FROG K834211 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Jun 1984. https://www.510kdatabase.net/k842222/ 1984-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k842222-dupont-aca-liquid-bilirubin-calibrator-fda-510k.jpg K842222 - DUPONT ACA LIQUID BILIRUBIN CALIBRATOR K842222 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Jun 1984. https://www.510kdatabase.net/k840864/ 1984-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k840864-gore-tex-catheter-fda-510k.jpg K840864 - GORE-TEX CATHETER K840864 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Jun 1984. https://www.510kdatabase.net/k841815/ 1984-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k841815-optimate-iga-test-fda-510k.jpg K841815 - OPTIMATE IGA TEST K841815 is a FDA 510(k) cleared immunology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Jun 1984. https://www.510kdatabase.net/k841951/ 1984-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k841951-microsurgical-knife-fda-510k.jpg K841951 - MICROSURGICAL KNIFE K841951 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Ethicon, Inc.. Cleared Jun 1984. https://www.510kdatabase.net/k841702/ 1984-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k841702-tdx-rea-uric-acid-fda-510k.jpg K841702 - TDX REA URIC ACID K841702 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared May 1984. https://www.510kdatabase.net/k841404/ 1984-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k841404-prima-236-02-nonprogrammable-cardiac-fda-510k.jpg K841404 - PRIMA 236-02 NONPROGRAMMABLE CARDIAC K841404 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared May 1984. https://www.510kdatabase.net/k832138/ 1984-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k832138-biomer-pledget-suture-buttress-fda-510k.jpg K832138 - BIOMER * PLEDGET SUTURE BUTTRESS K832138 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared May 1984. https://www.510kdatabase.net/k840258/ 1984-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k840258-tec-3500-defibrillator-fda-510k.jpg K840258 - TEC-3500 DEFIBRILLATOR K840258 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared May 1984. https://www.510kdatabase.net/k841503/ 1984-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k841503-kodak-ektachem-dt-60-analyzer-fda-510k.jpg K841503 - KODAK EKTACHEM DT 60 ANALYZER K841503 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared May 1984. https://www.510kdatabase.net/k841555/ 1984-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k841555-sigma-procedure-16-uv-fda-510k.jpg K841555 - SIGMA PROCEDURE 16-UV K841555 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared May 1984. https://www.510kdatabase.net/k841576/ 1984-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k841576-technicon-ra-1000-sys-t4-thyroxine-fda-510k.jpg K841576 - TECHNICON RA-1000 SYS T4-THYROXINE K841576 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared May 1984. https://www.510kdatabase.net/k841601/ 1984-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k841601-terumo-sensibead-thyroxine-eia-kit-fda-510k.jpg K841601 - TERUMO SENSIBEAD THYROXINE EIA KIT K841601 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Terumo Medical Corp.. Cleared May 1984. https://www.510kdatabase.net/k841606/ 1984-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k841606-blood-spot-neonatal-tsh-radioimmuno-fda-510k.jpg K841606 - BLOOD SPOT NEONATAL TSH RADIOIMMUNO K841606 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared May 1984. https://www.510kdatabase.net/k841656/ 1984-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k841656-dupont-theophylline-assay-kit-fda-510k.jpg K841656 - DUPONT THEOPHYLLINE ASSAY KIT K841656 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared May 1984. https://www.510kdatabase.net/k840879/ 1984-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k840879-toxo-g-eia-diagnostic-kit-fda-510k.jpg K840879 - TOXO-G EIA DIAGNOSTIC KIT K840879 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared May 1984. https://www.510kdatabase.net/k841518/ 1984-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k841518-johnson-johnson-posterior-dental-fda-510k.jpg K841518 - JOHNSON & JOHNSON POSTERIOR DENTAL (ADAPTIC II) K841518 is a FDA 510(k) cleared dental medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared May 1984. https://www.510kdatabase.net/k840121/ 1984-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k840121-physiological-pressure-transducer-1290c-fda-510k.jpg K840121 - PHYSIOLOGICAL PRESSURE TRANSDUCER 1290C K840121 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared May 1984. https://www.510kdatabase.net/k841073/ 1984-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k841073-quantum-unipolar-multi-programmable-fda-510k.jpg K841073 - QUANTUM, UNIPOLAR, MULTI-PROGRAMMABLE K841073 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared May 1984. https://www.510kdatabase.net/k841074/ 1984-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k841074-cardiac-pulse-generator-254-18-fda-510k.jpg K841074 - CARDIAC PULSE GENERATOR 254-18 K841074 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared May 1984. https://www.510kdatabase.net/k841075/ 1984-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k841075-carciac-pulse-generator-254-20-fda-510k.jpg K841075 - CARCIAC PULSE GENERATOR 254-20 K841075 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared May 1984. https://www.510kdatabase.net/k841439/ 1984-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k841439-coma-toxicology-control-fda-510k.jpg K841439 - COMA TOXICOLOGY CONTROL K841439 is a FDA 510(k) cleared toxicology medical device. Manufacturer: American Dade. Cleared May 1984. https://www.510kdatabase.net/k841471/ 1984-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k841471-ultra-chem-enzymatic-triglyceride-fda-510k.jpg K841471 - ULTRA CHEM ENZYMATIC TRIGLYCERIDE K841471 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Em Diagnostic Systems, Inc.. Cleared May 1984. https://www.510kdatabase.net/k841655/ 1984-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k841655-dupont-theophylline-dit-calibrator-fda-510k.jpg K841655 - DUPONT THEOPHYLLINE DIT CALIBRATOR K841655 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared May 1984. https://www.510kdatabase.net/k841307/ 1984-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k841307-bbl-gaspak-pouch-fda-510k.jpg K841307 - BBL GASPAK POUCH K841307 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared May 1984. https://www.510kdatabase.net/k841477/ 1984-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k841477-corometrics-815-fetal-ecg-recorder-fda-510k.jpg K841477 - COROMETRICS 815 FETAL ECG RECORDER K841477 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared May 1984. https://www.510kdatabase.net/k841498/ 1984-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k841498-c02-monitor-oir-7101-fda-510k.jpg K841498 - C02 MONITOR-OIR-7101 K841498 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared May 1984. https://www.510kdatabase.net/k841584/ 1984-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k841584-medtronic-resume-se-4-3587-lead-spinal-fda-510k.jpg K841584 - MEDTRONIC RESUME SE-4 3587-LEAD-SPINAL K841584 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared May 1984. https://www.510kdatabase.net/k840751/ 1984-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k840751-opaque-coating-surface-stain-fda-510k.jpg K840751 - OPAQUE COATING & SURFACE STAIN K840751 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared May 1984. https://www.510kdatabase.net/k840941/ 1984-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k840941-tdx-acetaminophen-fda-510k.jpg K840941 - TDX ACETAMINOPHEN K840941 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared May 1984. https://www.510kdatabase.net/k840954/ 1984-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k840954-dynamic-condylar-screw-or-dcs-fda-510k.jpg K840954 - DYNAMIC CONDYLAR SCREW OR D.C.S. K840954 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared May 1984. https://www.510kdatabase.net/k841118/ 1984-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k841118-prolactin-riabead-prolactin-radioimm-fda-510k.jpg K841118 - PROLACTIN RIABEAD PROLACTIN RADIOIMM K841118 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared May 1984. https://www.510kdatabase.net/k841533/ 1984-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k841533-aca-tricyclic-antidepressants-screen-fda-510k.jpg K841533 - ACA TRICYCLIC ANTIDEPRESSANTS SCREEN K841533 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared May 1984. https://www.510kdatabase.net/k841582/ 1984-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k841582-optimate-digoxin-test-fda-510k.jpg K841582 - OPTIMATE DIGOXIN TEST K841582 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared May 1984. https://www.510kdatabase.net/k841744/ 1984-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k841744-dulbeccos-phosphate-buffered-saline-fda-510k.jpg K841744 - DULBECCO'S PHOSPHATE BUFFERED SALINE K841744 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared May 1984. https://www.510kdatabase.net/k841181/ 1984-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k841181-astra-sys-inorganic-phosphorus-chem-fda-510k.jpg K841181 - ASTRA SYS INORGANIC PHOSPHORUS CHEM K841181 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared May 1984. https://www.510kdatabase.net/k841182/ 1984-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k841182-multiple-chem-module-for-analysis-fda-510k.jpg K841182 - MULTIPLE CHEM. MODULE FOR ANALYSIS K841182 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared May 1984. https://www.510kdatabase.net/k841485/ 1984-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k841485-urological-kit-wsterile-water-fill-fda-510k.jpg K841485 - UROLOGICAL KIT W/STERILE, WATER-FILL K841485 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medline Industries, Inc.. Cleared May 1984. https://www.510kdatabase.net/k834595/ 1984-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k834595-paragon-acid-hemoglobin-reagent-kit-fda-510k.jpg K834595 - PARAGON ACID HEMOGLOBIN REAGENT KIT K834595 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared May 1984. https://www.510kdatabase.net/k840494/ 1984-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k840494-microtrak-hsv-1-2-culture-fda-510k.jpg K840494 - MICROTRAK HSV 1 & 2 CULTURE K840494 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Syva Co.. Cleared May 1984. https://www.510kdatabase.net/k841094/ 1984-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k841094-human-growth-hormone-ria-kit-fda-510k.jpg K841094 - HUMAN GROWTH HORMONE RIA KIT K841094 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared May 1984. https://www.510kdatabase.net/k841259/ 1984-05-07 monthly 0.5 https://www.510kdatabase.net/og-image/k841259-determination-of-magnesium-in-serum-or-fda-510k.jpg K841259 - DETERMINATION OF MAGNESIUM IN SERUM OR K841259 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared May 1984. https://www.510kdatabase.net/k841020/ 1984-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k841020-fibrinogen-assay-kit-fda-510k.jpg K841020 - FIBRINOGEN ASSAY KIT K841020 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared May 1984. https://www.510kdatabase.net/k841080/ 1984-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k841080-technicon-ra-1000-sys-co2-fda-510k.jpg K841080 - TECHNICON RA-1000 SYS CO2 K841080 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared May 1984. https://www.510kdatabase.net/k841308/ 1984-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k841308-directigen-menningitis-test-kit-fda-510k.jpg K841308 - DIRECTIGEN MENNINGITIS TEST KIT K841308 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared May 1984. https://www.510kdatabase.net/k841532/ 1984-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k841532-aca-tricyclic-antidepressants-screen-tes-fda-510k.jpg K841532 - ACA TRICYCLIC ANTIDEPRESSANTS SCREEN TES K841532 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared May 1984. https://www.510kdatabase.net/k840848/ 1984-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k840848-biosure-fda-510k.jpg K840848 - BIOSURE K840848 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared May 1984. https://www.510kdatabase.net/k834567/ 1984-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k834567-q3000-fda-510k.jpg K834567 - Q3000 K834567 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Apr 1984. https://www.510kdatabase.net/k840195/ 1984-04-30 monthly 0.5 https://www.510kdatabase.net/og-image/k840195-facs-analyzer-fda-510k.jpg K840195 - FACS ANALYZER K840195 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1984. https://www.510kdatabase.net/k833797/ 1984-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k833797-light-cured-resin-bonded-ceramic-fda-510k.jpg K833797 - LIGHT CURED RESIN BONDED CERAMIC K833797 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Apr 1984. https://www.510kdatabase.net/k840138/ 1984-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k840138-qta-processor-module-fda-510k.jpg K840138 - QTA PROCESSOR MODULE K840138 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Apr 1984. https://www.510kdatabase.net/k840197/ 1984-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k840197-single-lumen-subclavian-cannula-fda-510k.jpg K840197 - SINGLE LUMEN SUBCLAVIAN CANNULA K840197 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Shiley, Inc.. Cleared Apr 1984. https://www.510kdatabase.net/k841175/ 1984-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k841175-william-harvey-h-4720-non-filtered-car-fda-510k.jpg K841175 - WILLIAM HARVEY H-4720 NON-FILTERED CAR K841175 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 1984. https://www.510kdatabase.net/k841364/ 1984-04-25 monthly 0.5 https://www.510kdatabase.net/og-image/k841364-coagulation-factor-v-deficient-substr-fda-510k.jpg K841364 - COAGULATION FACTOR V DEFICIENT SUBSTR K841364 is a FDA 510(k) cleared hematology medical device. Manufacturer: American Dade. Cleared Apr 1984. https://www.510kdatabase.net/k834416/ 1984-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k834416-lumelec-electrode-catheter-fda-510k.jpg K834416 - LUMELEC ELECTRODE CATHETER K834416 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Apr 1984. https://www.510kdatabase.net/k840939/ 1984-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k840939-emit-qst-primidone-assay-fda-510k.jpg K840939 - EMIT QST PRIMIDONE ASSAY K840939 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Apr 1984. https://www.510kdatabase.net/k840667/ 1984-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k840667-linear-scanner-640-fda-510k.jpg K840667 - LINEAR SCANNER 640 K840667 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Apr 1984. https://www.510kdatabase.net/k840963/ 1984-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k840963-sd-plus-patient-cat78-8010-fda-510k.jpg K840963 - SD PLUS PATIENT CAT.#78-8010 K840963 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Apr 1984. https://www.510kdatabase.net/k840964/ 1984-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k840964-sd-plus-clinician-cat-78-8015-fda-510k.jpg K840964 - SD PLUS CLINICIAN CAT# 78-8015 K840964 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Apr 1984. https://www.510kdatabase.net/k840415/ 1984-04-20 monthly 0.5 https://www.510kdatabase.net/og-image/k840415-hemocath-fda-510k.jpg K840415 - HEMOCATH K840415 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quinton, Inc.. Cleared Apr 1984. https://www.510kdatabase.net/k834349/ 1984-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k834349-anti-native-dna-antibody-fda-510k.jpg K834349 - ANTI-NATIVE DNA ANTIBODY K834349 is a FDA 510(k) cleared immunology medical device. Manufacturer: Sigma Chemical Co.. Cleared Apr 1984. https://www.510kdatabase.net/k840010/ 1984-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k840010-dade-hematology-calibrator-plus-fda-510k.jpg K840010 - DADE HEMATOLOGY CALIBRATOR PLUS K840010 is a FDA 510(k) cleared hematology medical device. Manufacturer: American Dade. Cleared Apr 1984. https://www.510kdatabase.net/k840603/ 1984-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k840603-arterial-filter-purge-line-wcheck-valv-fda-510k.jpg K840603 - ARTERIAL FILTER PURGE LINE W/CHECK VALV K840603 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Apr 1984. https://www.510kdatabase.net/k841047/ 1984-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k841047-paramax-chloride-reagent-fda-510k.jpg K841047 - PARAMAX CHLORIDE REAGENT K841047 is a FDA 510(k) cleared toxicology medical device. Manufacturer: American Dade. Cleared Apr 1984. https://www.510kdatabase.net/k841107/ 1984-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k841107-aca-digoxin-analytical-test-pack-fda-510k.jpg K841107 - ACA DIGOXIN ANALYTICAL TEST PACK K841107 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Apr 1984. https://www.510kdatabase.net/k841108/ 1984-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k841108-aca-digoxin-callibrator-fda-510k.jpg K841108 - ACA DIGOXIN CALLIBRATOR K841108 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Apr 1984. https://www.510kdatabase.net/k840880/ 1984-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k840880-ektachem-clinical-chem-slides-fda-510k.jpg K840880 - EKTACHEM CLINICAL CHEM. SLIDES K840880 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Apr 1984. https://www.510kdatabase.net/k840959/ 1984-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k840959-free-t3-solid-phase-radioimmunoassay-fda-510k.jpg K840959 - FREE T3 SOLID PHASE RADIOIMMUNOASSAY K840959 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1984. https://www.510kdatabase.net/k823234/ 1984-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k823234-radiation-sterilization-of-surg-gloves-fda-510k.jpg K823234 - RADIATION STERILIZATION OF SURG. GLOVES K823234 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1984. https://www.510kdatabase.net/k834032/ 1984-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k834032-rubaquick-diagnostic-kit-fda-510k.jpg K834032 - RUBAQUICK DIAGNOSTIC KIT K834032 is a FDA 510(k) cleared hematology medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1984. https://www.510kdatabase.net/k840274/ 1984-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k840274-cardiofax-ecg-6543-fda-510k.jpg K840274 - CARDIOFAX ECG 6543 K840274 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Apr 1984. https://www.510kdatabase.net/k840338/ 1984-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k840338-haemophilus-id-ii-triplate-fda-510k.jpg K840338 - HAEMOPHILUS I.D. II TRIPLATE K840338 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Apr 1984. https://www.510kdatabase.net/k840450/ 1984-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k840450-shiley-prebypass-filter-fda-510k.jpg K840450 - SHILEY PREBYPASS FILTER K840450 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Apr 1984. https://www.510kdatabase.net/k840643/ 1984-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k840643-harris-galante-porous-total-hip-sys-fda-510k.jpg K840643 - HARRIS-GALANTE POROUS TOTAL HIP SYS K840643 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Apr 1984. https://www.510kdatabase.net/k840658/ 1984-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k840658-qbc-centrifugal-hematology-analyz-fda-510k.jpg K840658 - QBC CENTRIFUGAL HEMATOLOGY ANALYZ K840658 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1984. https://www.510kdatabase.net/k840685/ 1984-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k840685-porphyrin-test-agar-fda-510k.jpg K840685 - PORPHYRIN TEST AGAR K840685 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Apr 1984. https://www.510kdatabase.net/k840914/ 1984-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k840914-argyle-tapered-vascular-shunt-fda-510k.jpg K840914 - ARGYLE TAPERED VASCULAR SHUNT K840914 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sherwood Medical Co.. Cleared Apr 1984. https://www.510kdatabase.net/k841079/ 1984-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k841079-william-harvey-h-4700-filtercardio-fda-510k.jpg K841079 - WILLIAM HARVEY H-4700 FILTER/CARDIO K841079 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 1984. https://www.510kdatabase.net/k840496/ 1984-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k840496-isostat-microbial-tube-processing-fda-510k.jpg K840496 - ISOSTAT MICROBIAL TUBE PROCESSING K840496 is a FDA 510(k) cleared microbiology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Apr 1984. https://www.510kdatabase.net/k840553/ 1984-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k840553-hemastaph-fda-510k.jpg K840553 - HEMASTAPH K840553 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Apr 1984. https://www.510kdatabase.net/k840614/ 1984-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k840614-rifampin-disc-fda-510k.jpg K840614 - RIFAMPIN DISC K840614 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Apr 1984. https://www.510kdatabase.net/k840686/ 1984-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k840686-2u-penicillin-disc-fda-510k.jpg K840686 - 2U PENICILLIN DISC K840686 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Apr 1984. https://www.510kdatabase.net/k840708/ 1984-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k840708-colistin-disc-fda-510k.jpg K840708 - COLISTIN DISC K840708 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Apr 1984. https://www.510kdatabase.net/k840769/ 1984-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k840769-paramax-alcohol-reagent-fda-510k.jpg K840769 - PARAMAX ALCOHOL REAGENT K840769 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Apr 1984. https://www.510kdatabase.net/k840771/ 1984-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k840771-alcohol-ammonia-calibrator-i-fda-510k.jpg K840771 - ALCOHOL & AMMONIA CALIBRATOR I K840771 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Apr 1984. https://www.510kdatabase.net/k840772/ 1984-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k840772-alcohol-ammonia-calibrator-ii-fda-510k.jpg K840772 - ALCOHOL & AMMONIA CALIBRATOR II K840772 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Apr 1984. https://www.510kdatabase.net/k840778/ 1984-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k840778-lactate-reagent-fda-510k.jpg K840778 - LACTATE REAGENT K840778 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Apr 1984. https://www.510kdatabase.net/k840779/ 1984-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k840779-neonatal-bilirubin-reagent-fda-510k.jpg K840779 - NEONATAL BILIRUBIN REAGENT K840779 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Apr 1984. https://www.510kdatabase.net/k840781/ 1984-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k840781-uric-acid-reagent-fda-510k.jpg K840781 - URIC ACID REAGENT K840781 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Apr 1984. https://www.510kdatabase.net/k840782/ 1984-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k840782-albumin-reagent-fda-510k.jpg K840782 - ALBUMIN REAGENT K840782 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Apr 1984. https://www.510kdatabase.net/k840784/ 1984-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k840784-paramax-magnesium-reagent-fda-510k.jpg K840784 - PARAMAX MAGNESIUM REAGENT K840784 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Apr 1984. https://www.510kdatabase.net/k840826/ 1984-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k840826-tdx-ethanol-fda-510k.jpg K840826 - TDX ETHANOL K840826 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1984. https://www.510kdatabase.net/k845052/ 1984-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k845052-paramax-total-protein-reagent-tp-fda-510k.jpg K845052 - PARAMAX TOTAL PROTEIN REAGENT TP K845052 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Apr 1984. https://www.510kdatabase.net/k833830/ 1984-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k833830-3-day-bioindicator-release-process-for-fda-510k.jpg K833830 - 3-DAY BIOINDICATOR RELEASE PROCESS FOR K833830 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Apr 1984. https://www.510kdatabase.net/k834432/ 1984-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k834432-anthro-modular-total-knee-fda-510k.jpg K834432 - ANTHRO-MODULAR TOTAL KNEE K834432 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Apr 1984. https://www.510kdatabase.net/k834574/ 1984-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k834574-usci-endoprosthesis-fda-510k.jpg K834574 - USCI ENDOPROSTHESIS K834574 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 1984. https://www.510kdatabase.net/k840329/ 1984-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k840329-ristocetin-cofactor-assay-fda-510k.jpg K840329 - RISTOCETIN COFACTOR ASSAY K840329 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Apr 1984. https://www.510kdatabase.net/k840760/ 1984-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k840760-harvard-anti-reflux-y-set-fda-510k.jpg K840760 - HARVARD ANTI-REFLUX Y-SET K840760 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 1984. https://www.510kdatabase.net/k840777/ 1984-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k840777-direct-bilirubin-reagent-fda-510k.jpg K840777 - DIRECT BILIRUBIN REAGENT K840777 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Apr 1984. https://www.510kdatabase.net/k840780/ 1984-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k840780-triglycerides-reagent-fda-510k.jpg K840780 - TRIGLYCERIDES REAGENT K840780 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Apr 1984. https://www.510kdatabase.net/k840785/ 1984-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k840785-paramax-urea-nitrogen-reagent-fda-510k.jpg K840785 - PARAMAX UREA NITROGEN REAGENT K840785 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Apr 1984. https://www.510kdatabase.net/k840596/ 1984-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k840596-quinidine-analytical-test-pack-fda-510k.jpg K840596 - QUINIDINE ANALYTICAL TEST PACK K840596 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Apr 1984. https://www.510kdatabase.net/k840606/ 1984-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k840606-ektachem-clinical-chem-slides-fda-510k.jpg K840606 - EKTACHEM CLINICAL CHEM. SLIDES K840606 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Apr 1984. https://www.510kdatabase.net/k840661/ 1984-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k840661-paramax-acid-phosphatase-reagent-fda-510k.jpg K840661 - PARAMAX ACID PHOSPHATASE REAGENT K840661 is a FDA 510(k) cleared hematology medical device. Manufacturer: American Dade. Cleared Apr 1984. https://www.510kdatabase.net/k840674/ 1984-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k840674-sensibead-eia-ige-kit-fda-510k.jpg K840674 - SENSIBEAD EIA IGE KIT K840674 is a FDA 510(k) cleared immunology medical device. Manufacturer: Terumo Medical Corp.. Cleared Apr 1984. https://www.510kdatabase.net/k840706/ 1984-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k840706-aspartate-aminotransferase-reagent-fda-510k.jpg K840706 - ASPARTATE AMINOTRANSFERASE REAGENT K840706 is a FDA 510(k) cleared hematology medical device. Manufacturer: American Dade. Cleared Apr 1984. https://www.510kdatabase.net/k840770/ 1984-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k840770-paramax-ammonia-reagentt-fda-510k.jpg K840770 - PARAMAX AMMONIA REAGENTT K840770 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Apr 1984. https://www.510kdatabase.net/k840773/ 1984-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k840773-carbon-dioxide-reagent-fda-510k.jpg K840773 - CARBON DIOXIDE REAGENT K840773 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Apr 1984. https://www.510kdatabase.net/k840774/ 1984-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k840774-carbon-dioxide-calibrator-i-fda-510k.jpg K840774 - CARBON DIOXIDE CALIBRATOR I K840774 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Apr 1984. https://www.510kdatabase.net/k840775/ 1984-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k840775-carbon-dioxide-calibrator-ii-fda-510k.jpg K840775 - CARBON DIOXIDE CALIBRATOR II K840775 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Apr 1984. https://www.510kdatabase.net/k840776/ 1984-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k840776-paramax-cholesterol-reagent-fda-510k.jpg K840776 - PARAMAX CHOLESTEROL REAGENT K840776 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Apr 1984. https://www.510kdatabase.net/k840783/ 1984-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k840783-creatine-kinase-mb-reagent-fda-510k.jpg K840783 - CREATINE KINASE MB REAGENT K840783 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Apr 1984. https://www.510kdatabase.net/k841026/ 1984-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k841026-manual-blood-cell-counting-device-fda-510k.jpg K841026 - MANUAL BLOOD CELL COUNTING DEVICE K841026 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Apr 1984. https://www.510kdatabase.net/k841029/ 1984-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k841029-bangort-lifestyle-colostomy-pouches-fda-510k.jpg K841029 - BANGORT LIFESTYLE COLOSTOMY POUCHES K841029 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Howmedica Corp.. Cleared Apr 1984. https://www.510kdatabase.net/k841117/ 1984-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k841117-gaspak-plus-dispos-hydrogen-fda-510k.jpg K841117 - GASPAK PLUS DISPOS. HYDROGEN & K841117 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1984. https://www.510kdatabase.net/k840647/ 1984-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k840647-amikacin-reagent-test-kit-fda-510k.jpg K840647 - AMIKACIN REAGENT TEST KIT K840647 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Apr 1984. https://www.510kdatabase.net/k840878/ 1984-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k840878-quik-lok-fda-510k.jpg K840878 - QUIK LOK K840878 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1984. https://www.510kdatabase.net/k833681/ 1984-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k833681-porocoat-hps-ii-hip-prosthesis-fda-510k.jpg K833681 - POROCOAT HPS II HIP PROSTHESIS K833681 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Mar 1984. https://www.510kdatabase.net/k833981/ 1984-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k833981-shiley-dispos-temp-probes-fda-510k.jpg K833981 - SHILEY DISPOS. TEMP. PROBES K833981 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shiley, Inc.. Cleared Mar 1984. https://www.510kdatabase.net/k840018/ 1984-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k840018-dpc-acth-kit-fda-510k.jpg K840018 - DPC ACTH KIT K840018 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Mar 1984. https://www.510kdatabase.net/k840051/ 1984-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k840051-coat-a-count-estradiol-kit-fda-510k.jpg K840051 - COAT-A-COUNT ESTRADIOL KIT K840051 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Mar 1984. https://www.510kdatabase.net/k840193/ 1984-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k840193-emit-qst-amikacin-assay-fda-510k.jpg K840193 - EMIT QST AMIKACIN ASSAY K840193 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Mar 1984. https://www.510kdatabase.net/k840243/ 1984-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k840243-determin-of-salicylate-in-serumplast-fda-510k.jpg K840243 - DETERMIN. OF SALICYLATE IN SERUM/PLAST K840243 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Mar 1984. https://www.510kdatabase.net/k840400/ 1984-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k840400-emit-st-serum-ethyl-alcohol-assay-fda-510k.jpg K840400 - EMIT ST SERUM ETHYL ALCOHOL ASSAY K840400 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Mar 1984. https://www.510kdatabase.net/k840597/ 1984-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k840597-quinidine-calibrator-fda-510k.jpg K840597 - QUINIDINE CALIBRATOR K840597 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Mar 1984. https://www.510kdatabase.net/k840644/ 1984-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k840644-flo-gard-4000-volumetric-infusion-fda-510k.jpg K840644 - FLO-GARD 4000 VOLUMETRIC INFUSION K840644 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Mar 1984. https://www.510kdatabase.net/k840819/ 1984-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k840819-microdase-fda-510k.jpg K840819 - MICRODASE K840819 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Mar 1984. https://www.510kdatabase.net/k840889/ 1984-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k840889-clostridium-difficile-agar-deep-fda-510k.jpg K840889 - CLOSTRIDIUM DIFFICILE AGAR DEEP & K840889 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Mar 1984. https://www.510kdatabase.net/k840890/ 1984-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k840890-buffered-cye-agar-deep-wsupplements-fda-510k.jpg K840890 - BUFFERED CYE AGAR DEEP W/SUPPLEMENTS K840890 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Mar 1984. https://www.510kdatabase.net/k840981/ 1984-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k840981-niacin-reagent-strip-fda-510k.jpg K840981 - NIACIN REAGENT STRIP K840981 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Mar 1984. https://www.510kdatabase.net/k833913/ 1984-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k833913-hemodynamic-plug-in-module-78551a-fda-510k.jpg K833913 - HEMODYNAMIC PLUG-IN MODULE 78551A K833913 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Mar 1984. https://www.510kdatabase.net/k833914/ 1984-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k833914-cardiac-output-signal-acquistion-fda-510k.jpg K833914 - CARDIAC OUTPUT SIGNAL ACQUISTION K833914 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Mar 1984. https://www.510kdatabase.net/k840151/ 1984-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k840151-ektachem-clinical-chem-slides-fda-510k.jpg K840151 - EKTACHEM CLINICAL CHEM. SLIDES K840151 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Mar 1984. https://www.510kdatabase.net/k840164/ 1984-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k840164-emit-st-urine-methaqualone-assay-fda-510k.jpg K840164 - EMIT ST URINE METHAQUALONE ASSAY K840164 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Mar 1984. https://www.510kdatabase.net/k840199/ 1984-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k840199-emit-st-serum-phencyclidine-assay-fda-510k.jpg K840199 - EMIT ST SERUM PHENCYCLIDINE ASSAY K840199 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Mar 1984. https://www.510kdatabase.net/k833831/ 1984-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k833831-3-day-bioindicator-release-for-steril-fda-510k.jpg K833831 - 3-DAY BIOINDICATOR RELEASE FOR STERIL K833831 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shiley, Inc.. Cleared Mar 1984. https://www.510kdatabase.net/k832825/ 1984-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k832825-seralyzer-theophylline-reagent-strips-fda-510k.jpg K832825 - SERALYZER THEOPHYLLINE REAGENT STRIPS K832825 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Mar 1984. https://www.510kdatabase.net/k833442/ 1984-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k833442-pediatric-right-atrial-catheter-13mm-fda-510k.jpg K833442 - PEDIATRIC RIGHT ATRIAL CATHETER 1/3MM K833442 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Quinton, Inc.. Cleared Mar 1984. https://www.510kdatabase.net/k833599/ 1984-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k833599-modified-hps-hip-prosthesis-fda-510k.jpg K833599 - MODIFIED HPS HIP PROSTHESIS K833599 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Mar 1984. https://www.510kdatabase.net/k833954/ 1984-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k833954-melolite-fda-510k.jpg K833954 - MELOLITE K833954 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Mar 1984. https://www.510kdatabase.net/k833977/ 1984-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k833977-seralyzer-drug-assay-control-serum-fda-510k.jpg K833977 - SERALYZER DRUG ASSAY CONTROL SERUM K833977 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Mar 1984. https://www.510kdatabase.net/k833990/ 1984-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k833990-spinal-cord-stimulation-sys-se-4-fda-510k.jpg K833990 - SPINAL CORD STIMULATION SYS SE-4 K833990 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Mar 1984. https://www.510kdatabase.net/k834477/ 1984-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k834477-dispos-scott-cannulas-16-1054-etc-fda-510k.jpg K834477 - DISPOS. SCOTT CANNULAS 16-1054 ETC. K834477 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Mar 1984. https://www.510kdatabase.net/k834549/ 1984-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k834549-emit-st-urine-cocaine-metabolite-fda-510k.jpg K834549 - EMIT ST. URINE COCAINE METABOLITE K834549 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Mar 1984. https://www.510kdatabase.net/k834550/ 1984-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k834550-emit-st-serum-tricyclic-antidepressant-fda-510k.jpg K834550 - EMIT ST SERUM TRICYCLIC ANTIDEPRESSANT K834550 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Mar 1984. https://www.510kdatabase.net/k840050/ 1984-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k840050-sopheia-t3-eia-kit-fda-510k.jpg K840050 - SOPHEIA T3 EIA KIT K840050 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Mar 1984. https://www.510kdatabase.net/k840060/ 1984-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k840060-emit-st-urine-methadone-assay-fda-510k.jpg K840060 - EMIT ST URINE METHADONE ASSAY K840060 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Mar 1984. https://www.510kdatabase.net/k840061/ 1984-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k840061-emit-st-urine-phencyclidine-assay-fda-510k.jpg K840061 - EMIT ST URINE PHENCYCLIDINE ASSAY K840061 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Mar 1984. https://www.510kdatabase.net/k840171/ 1984-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k840171-emit-st-urine-ethyl-alcohol-assay-fda-510k.jpg K840171 - EMIT ST URINE ETHYL ALCOHOL ASSAY K840171 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Mar 1984. https://www.510kdatabase.net/k840194/ 1984-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k840194-emit-st-serum-barbiturate-assay-fda-510k.jpg K840194 - EMIT ST SERUM BARBITURATE ASSAY K840194 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Mar 1984. https://www.510kdatabase.net/k840236/ 1984-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k840236-emit-st-serum-benzodiazepine-assay-fda-510k.jpg K840236 - EMIT ST SERUM BENZODIAZEPINE ASSAY K840236 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Mar 1984. https://www.510kdatabase.net/k833611/ 1984-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k833611-titan-gel-lipoprotein-electrophoresis-fda-510k.jpg K833611 - TITAN GEL LIPOPROTEIN ELECTROPHORESIS K833611 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Mar 1984. https://www.510kdatabase.net/k833832/ 1984-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k833832-3-day-bioindicator-release-for-respir-fda-510k.jpg K833832 - 3-DAY BIOINDICATOR RELEASE FOR RESPIR K833832 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shiley, Inc.. Cleared Mar 1984. https://www.510kdatabase.net/k834102/ 1984-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k834102-ra-1000-sys-t4thyroxineserum-anal-fda-510k.jpg K834102 - RA-1000 SYS-T4(THYROXINE)SERUM ANAL K834102 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Mar 1984. https://www.510kdatabase.net/k833916/ 1984-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k833916-hypafix-dressing-retention-sheet-fda-510k.jpg K833916 - HYPAFIX DRESSING RETENTION SHEET K833916 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Mar 1984. https://www.510kdatabase.net/k834249/ 1984-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k834249-monoject-soft-tissue-biopsy-needle-fda-510k.jpg K834249 - MONOJECT SOFT TISSUE BIOPSY NEEDLE K834249 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Sherwood Medical Co.. Cleared Mar 1984. https://www.510kdatabase.net/k834267/ 1984-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k834267-ligaclip-metallic-ligating-clip-fda-510k.jpg K834267 - LIGACLIP METALLIC LIGATING CLIP K834267 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Mar 1984. https://www.510kdatabase.net/k840354/ 1984-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k840354-monoject-soft-tissue-biopsyfine-needle-fda-510k.jpg K840354 - MONOJECT SOFT TISSUE BIOPSY/FINE NEEDLE K840354 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Sherwood Medical Co.. Cleared Mar 1984. https://www.510kdatabase.net/k840673/ 1984-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k840673-sensibead-eia-digoxin-kit-fda-510k.jpg K840673 - SENSIBEAD EIA DIGOXIN KIT K840673 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Terumo Medical Corp.. Cleared Mar 1984. https://www.510kdatabase.net/k840798/ 1984-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k840798-amyloid-stain-congo-red-ht-60-fda-510k.jpg K840798 - AMYLOID STAIN, CONGO RED HT 60 K840798 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Mar 1984. https://www.510kdatabase.net/k840926/ 1984-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k840926-formalin-solution-10-neutral-buffer-fda-510k.jpg K840926 - FORMALIN SOLUTION 10% NEUTRAL BUFFER K840926 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Mar 1984. https://www.510kdatabase.net/k834149/ 1984-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k834149-autogrouper-16c-sys-automated-reag-fda-510k.jpg K834149 - AUTOGROUPER 16C SYS AUTOMATED REAG K834149 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Mar 1984. https://www.510kdatabase.net/k834209/ 1984-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k834209-stratus-thyroid-uptake-fluorometric-fda-510k.jpg K834209 - STRATUS THYROID UPTAKE FLUOROMETRIC K834209 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Mar 1984. https://www.510kdatabase.net/k840539/ 1984-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k840539-dispos-low-press-cuffed-tracheostomy-fda-510k.jpg K840539 - DISPOS. LOW PRESS. CUFFED TRACHEOSTOMY K840539 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shiley, Inc.. Cleared Mar 1984. https://www.510kdatabase.net/k840615/ 1984-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k840615-yersinia-supplement-fda-510k.jpg K840615 - YERSINIA SUPPLEMENT K840615 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Mar 1984. https://www.510kdatabase.net/k840705/ 1984-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k840705-paramax-alanine-aminotransferase-fda-510k.jpg K840705 - PARAMAX ALANINE AMINOTRANSFERASE K840705 is a FDA 510(k) cleared hematology medical device. Manufacturer: American Dade. Cleared Mar 1984. https://www.510kdatabase.net/k834548/ 1984-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k834548-hypodermic-syringes-needles-fda-510k.jpg K834548 - HYPODERMIC SYRINGES & NEEDLES K834548 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cordis Corp.. Cleared Mar 1984. https://www.510kdatabase.net/k834553/ 1984-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k834553-intradiscal-therapy-tray-fda-510k.jpg K834553 - INTRADISCAL THERAPY TRAY K834553 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1984. https://www.510kdatabase.net/k834210/ 1984-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k834210-stratus-total-thyroxine-fluorometric-fda-510k.jpg K834210 - STRATUS TOTAL THYROXINE FLUOROMETRIC K834210 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Mar 1984. https://www.510kdatabase.net/k840424/ 1984-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k840424-hemocath-repair-kit-fda-510k.jpg K840424 - HEMOCATH REPAIR KIT K840424 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quinton, Inc.. Cleared Mar 1984. https://www.510kdatabase.net/k832919/ 1984-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k832919-opti-beam-iv-fda-510k.jpg K832919 - OPTI-BEAM IV K832919 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Mar 1984. https://www.510kdatabase.net/k833439/ 1984-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k833439-porocoat-neb-total-hip-system-fda-510k.jpg K833439 - POROCOAT NEB TOTAL HIP SYSTEM K833439 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Mar 1984. https://www.510kdatabase.net/k840483/ 1984-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k840483-novobiocin-disc-fda-510k.jpg K840483 - NOVOBIOCIN DISC K840483 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Mar 1984. https://www.510kdatabase.net/k840003/ 1984-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k840003-disposable-icp-kit-diff-sizes-fda-510k.jpg K840003 - DISPOSABLE ICP KIT DIFF. SIZES K840003 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Feb 1984. https://www.510kdatabase.net/k833855/ 1984-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k833855-titan-gel-silver-stain-system-fda-510k.jpg K833855 - TITAN GEL SILVER STAIN SYSTEM K833855 is a FDA 510(k) cleared pathology medical device. Manufacturer: Helena Laboratories. Cleared Feb 1984. https://www.510kdatabase.net/k834409/ 1984-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k834409-denture-base-resin-fda-510k.jpg K834409 - DENTURE BASE RESIN K834409 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Feb 1984. https://www.510kdatabase.net/k834502/ 1984-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k834502-ck-nac-reagent-fda-510k.jpg K834502 - CK-NAC REAGENT K834502 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared Feb 1984. https://www.510kdatabase.net/k834521/ 1984-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k834521-discrete-clinical-analyzer-fda-510k.jpg K834521 - DISCRETE CLINICAL ANALYZER K834521 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Feb 1984. https://www.510kdatabase.net/k840251/ 1984-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k840251-patient-monitor-78534b-fda-510k.jpg K840251 - PATIENT MONITOR 78534B K840251 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Feb 1984. https://www.510kdatabase.net/k840263/ 1984-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k840263-lifecare-4homecare-4h-pump-fda-510k.jpg K840263 - LIFECARE 4/HOMECARE - 4H PUMP K840263 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Feb 1984. https://www.510kdatabase.net/k840554/ 1984-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k840554-blood-agar-wampicillin-fda-510k.jpg K840554 - BLOOD AGAR W/AMPICILLIN K840554 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Feb 1984. https://www.510kdatabase.net/k834484/ 1984-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k834484-cronex-sr-337-fda-510k.jpg K834484 - CRONEX SR-337 K834484 is a FDA 510(k) cleared radiology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Feb 1984. https://www.510kdatabase.net/k840224/ 1984-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k840224-extended-life-capd-solution-transfer-fda-510k.jpg K840224 - EXTENDED LIFE CAPD SOLUTION TRANSFER K840224 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Feb 1984. https://www.510kdatabase.net/k840054/ 1984-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k840054-papanicolaou-stain-sys-ht40-fda-510k.jpg K840054 - PAPANICOLAOU STAIN SYS HT40 K840054 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Chemical Co.. Cleared Feb 1984. https://www.510kdatabase.net/k840190/ 1984-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k840190-macconkey-agar-wtween-80-ampicil-fda-510k.jpg K840190 - MACCONKEY AGAR W/TWEEN 80 & AMPICIL K840190 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Feb 1984. https://www.510kdatabase.net/k840294/ 1984-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k840294-group-a-selective-agar-w5-sheep-blood-fda-510k.jpg K840294 - GROUP A SELECTIVE AGAR W/5% SHEEP BLOOD K840294 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Feb 1984. https://www.510kdatabase.net/k840467/ 1984-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k840467-neuromuscular-stimulator-3105-fda-510k.jpg K840467 - NEUROMUSCULAR STIMULATOR 3105 K840467 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Medtronic Vascular. Cleared Feb 1984. https://www.510kdatabase.net/k833363/ 1984-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k833363-cloutier-ii-fiber-metal-total-knee-fda-510k.jpg K833363 - CLOUTIER II FIBER METAL TOTAL KNEE K833363 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Feb 1984. https://www.510kdatabase.net/k834225/ 1984-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k834225-raaf-dual-lumen-cath-repair-kit-22-fda-510k.jpg K834225 - RAAF DUAL LUMEN CATH. REPAIR KIT 2.2 K834225 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Quinton, Inc.. Cleared Feb 1984. https://www.510kdatabase.net/k834271/ 1984-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k834271-reflocheck-glucose-test-strip-sys-fda-510k.jpg K834271 - REFLOCHECK & GLUCOSE TEST STRIP SYS K834271 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Feb 1984. https://www.510kdatabase.net/k834298/ 1984-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k834298-unicondylar-fiber-metal-knee-fda-510k.jpg K834298 - UNICONDYLAR FIBER METAL KNEE K834298 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Feb 1984. https://www.510kdatabase.net/k833646/ 1984-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k833646-pulsatron-nerve-locatorstimulator-fda-510k.jpg K833646 - PULSATRON NERVE LOCATOR/STIMULATOR K833646 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Edward Weck, Inc.. Cleared Feb 1984. https://www.510kdatabase.net/k833952/ 1984-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k833952-fixation-pins-fda-510k.jpg K833952 - FIXATION PINS K833952 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ethicon, Inc.. Cleared Feb 1984. https://www.510kdatabase.net/k834580/ 1984-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k834580-reach-toothbrush-fda-510k.jpg K834580 - REACH* TOOTHBRUSH K834580 is a FDA 510(k) cleared dental medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Feb 1984. https://www.510kdatabase.net/k840049/ 1984-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k840049-sopheia-mp-igm-rheumatoid-factor-eia-fda-510k.jpg K840049 - SOPHEIA MP IGM RHEUMATOID FACTOR EIA K840049 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Feb 1984. https://www.510kdatabase.net/k840286/ 1984-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k840286-brooker-external-fixation-frame-fda-510k.jpg K840286 - BROOKER EXTERNAL FIXATION FRAME K840286 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Feb 1984. https://www.510kdatabase.net/k833555/ 1984-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k833555-lal-test-release-bonchek-carjacket-fda-510k.jpg K833555 - LAL TEST RELEASE & BONCHEK CAR/JACKET K833555 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Feb 1984. https://www.510kdatabase.net/k833836/ 1984-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k833836-il-heparinized-flow-directed-thermal-fda-510k.jpg K833836 - IL HEPARINIZED FLOW DIRECTED THERMAL K833836 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Feb 1984. https://www.510kdatabase.net/k834050/ 1984-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k834050-protopath-factor-ix-assay-fda-510k.jpg K834050 - PROTOPATH FACTOR IX ASSAY K834050 is a FDA 510(k) cleared hematology medical device. Manufacturer: American Dade. Cleared Feb 1984. https://www.510kdatabase.net/k834051/ 1984-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k834051-protopath-factor-viii-assay-fda-510k.jpg K834051 - PROTOPATH FACTOR VIII ASSAY K834051 is a FDA 510(k) cleared hematology medical device. Manufacturer: American Dade. Cleared Feb 1984. https://www.510kdatabase.net/k834057/ 1984-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k834057-il-301-portable-transcut-oxygen-moni-fda-510k.jpg K834057 - IL 301 PORTABLE TRANSCUT. OXYGEN MONI K834057 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Feb 1984. https://www.510kdatabase.net/k834109/ 1984-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k834109-mahurkar-dual-limen-femoral-catheter-fda-510k.jpg K834109 - MAHURKAR DUAL LIMEN FEMORAL CATHETER K834109 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Feb 1984. https://www.510kdatabase.net/k834438/ 1984-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k834438-temperature-sensing-foley-catheter-fda-510k.jpg K834438 - TEMPERATURE SENSING FOLEY CATHETER K834438 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Feb 1984. https://www.510kdatabase.net/k834480/ 1984-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k834480-injection-cap-fda-510k.jpg K834480 - INJECTION CAP K834480 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Feb 1984. https://www.510kdatabase.net/k834575/ 1984-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k834575-bard-karaya-gum-washers-fda-510k.jpg K834575 - BARD KARAYA GUM WASHERS K834575 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Feb 1984. https://www.510kdatabase.net/k834599/ 1984-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k834599-autotechnicon-v-tissue-process-sys-fda-510k.jpg K834599 - AUTOTECHNICON V TISSUE PROCESS SYS K834599 is a FDA 510(k) cleared pathology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Feb 1984. https://www.510kdatabase.net/k834046/ 1984-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k834046-luxene-vinyl-ject-3600-80-fda-510k.jpg K834046 - LUXENE VINYL-JECT 3600-80 K834046 is a FDA 510(k) cleared dental medical device. Manufacturer: Howmedica Corp.. Cleared Feb 1984. https://www.510kdatabase.net/k834406/ 1984-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k834406-emit-qst-phenytoin-assay-fda-510k.jpg K834406 - EMIT QST PHENYTOIN ASSAY K834406 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Feb 1984. https://www.510kdatabase.net/k834464/ 1984-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k834464-tdx-procainamide-fda-510k.jpg K834464 - TDX PROCAINAMIDE K834464 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Feb 1984. https://www.510kdatabase.net/k833921/ 1984-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k833921-agc-total-knee-prosthesis-fda-510k.jpg K833921 - AGC TOTAL KNEE PROSTHESIS K833921 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jan 1984. https://www.510kdatabase.net/k832991/ 1984-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k832991-hypal-adhesive-tape-fda-510k.jpg K832991 - HYPAL ADHESIVE TAPE K832991 is a FDA 510(k) cleared neurology medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jan 1984. https://www.510kdatabase.net/k833142/ 1984-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k833142-antibody-to-intrinsic-factor-radioassay-fda-510k.jpg K833142 - ANTIBODY TO INTRINSIC FACTOR RADIOASSAY K833142 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jan 1984. https://www.510kdatabase.net/k833421/ 1984-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k833421-programmable-stimulator-2352-fda-510k.jpg K833421 - PROGRAMMABLE STIMULATOR 2352 K833421 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jan 1984. https://www.510kdatabase.net/k833489/ 1984-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k833489-dpc-gastrin-kit-fda-510k.jpg K833489 - DPC GASTRIN KIT K833489 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jan 1984. https://www.510kdatabase.net/k833703/ 1984-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k833703-aca-thyroxine-uptake-analytical-test-fda-510k.jpg K833703 - ACA THYROXINE UPTAKE ANALYTICAL TEST K833703 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Jan 1984. https://www.510kdatabase.net/k833796/ 1984-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k833796-chem-kit-phenobarbital-fda-510k.jpg K833796 - CHEM KIT PHENOBARBITAL K833796 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Jan 1984. https://www.510kdatabase.net/k833806/ 1984-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k833806-chemkit-phenytoin-diag-kit-fda-510k.jpg K833806 - CHEMKIT PHENYTOIN DIAG. KIT K833806 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Jan 1984. https://www.510kdatabase.net/k833998/ 1984-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k833998-qca-chemistry-analyzer-fda-510k.jpg K833998 - QCA CHEMISTRY ANALYZER K833998 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jan 1984. https://www.510kdatabase.net/k834026/ 1984-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k834026-rdw-parameter-for-the-technicon-h6000-fda-510k.jpg K834026 - RDW PARAMETER FOR THE TECHNICON H6000 K834026 is a FDA 510(k) cleared hematology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Jan 1984. https://www.510kdatabase.net/k834289/ 1984-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k834289-continu-flo-solution-admin-2c9102-fda-510k.jpg K834289 - CONTINU-FLO SOLUTION ADMIN. 2C9102 K834289 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Jan 1984. https://www.510kdatabase.net/k834583/ 1984-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k834583-clear-leads-radiotransparent-wires-fda-510k.jpg K834583 - CLEAR LEADS-RADIOTRANSPARENT WIRES K834583 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Quinton, Inc.. Cleared Jan 1984. https://www.510kdatabase.net/k834603/ 1984-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k834603-transferrin-antigen-antibody-control-fda-510k.jpg K834603 - TRANSFERRIN, ANTIGEN, ANTIBODY, CONTROL K834603 is a FDA 510(k) cleared immunology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Jan 1984. https://www.510kdatabase.net/k832448/ 1984-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k832448-triflex-surgeons-gloves-fda-510k.jpg K832448 - TRIFLEX SURGEON'S GLOVES K832448 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Jan 1984. https://www.510kdatabase.net/k832765/ 1984-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k832765-flexi-ty-fda-510k.jpg K832765 - FLEXI-TY K832765 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jan 1984. https://www.510kdatabase.net/k833078/ 1984-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k833078-hollow-fiber-membrane-oxygenator-hf4000-fda-510k.jpg K833078 - HOLLOW FIBER MEMBRANE OXYGENATOR-HF4000 K833078 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Jan 1984. https://www.510kdatabase.net/k833081/ 1984-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k833081-absorable-polyglactin-910-anastomotic-fda-510k.jpg K833081 - ABSORABLE POLYGLACTIN 910-ANASTOMOTIC K833081 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Jan 1984. https://www.510kdatabase.net/k833464/ 1984-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k833464-porocoat-schatzker-acetabulum-fda-510k.jpg K833464 - POROCOAT SCHATZKER ACETABULUM K833464 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jan 1984. https://www.510kdatabase.net/k833552/ 1984-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k833552-trend-processor-option-for-515-neonat-fda-510k.jpg K833552 - TREND PROCESSOR OPTION FOR #515 NEONAT K833552 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Jan 1984. https://www.510kdatabase.net/k833970/ 1984-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k833970-micro-structured-hs2p-hip-stems-fda-510k.jpg K833970 - MICRO-STRUCTURED HS2P HIP STEMS K833970 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Jan 1984. https://www.510kdatabase.net/k834509/ 1984-01-27 monthly 0.5 https://www.510kdatabase.net/og-image/k834509-acetamide-agar-slants-fda-510k.jpg K834509 - ACETAMIDE AGAR SLANTS K834509 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jan 1984. https://www.510kdatabase.net/k833577/ 1984-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k833577-modif-of-emit-urine-barbiturate-fda-510k.jpg K833577 - MODIF. OF EMIT URINE BARBITURATE K833577 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jan 1984. https://www.510kdatabase.net/k833578/ 1984-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k833578-modif-of-emit-urine-benzodiazepine-fda-510k.jpg K833578 - MODIF. OF EMIT URINE BENZODIAZEPINE K833578 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jan 1984. https://www.510kdatabase.net/k833579/ 1984-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k833579-modif-of-emit-urine-amphetamine-fda-510k.jpg K833579 - MODIF. OF EMIT URINE AMPHETAMINE K833579 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jan 1984. https://www.510kdatabase.net/k833580/ 1984-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k833580-modif-of-emit-urine-cannabinoid-fda-510k.jpg K833580 - MODIF. OF EMIT URINE CANNABINOID K833580 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jan 1984. https://www.510kdatabase.net/k833581/ 1984-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k833581-modif-of-emit-urine-opiate-assay-fda-510k.jpg K833581 - MODIF. OF EMIT URINE OPIATE ASSAY K833581 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jan 1984. https://www.510kdatabase.net/k834154/ 1984-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k834154-flo-gard-8000-computer-control-infusi-fda-510k.jpg K834154 - FLO-GARD 8000 COMPUTER CONTROL INFUSI K834154 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Jan 1984. https://www.510kdatabase.net/k833402/ 1984-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k833402-tech-ra-1000sys-analytes-immunoglobulin-fda-510k.jpg K833402 - TECH. RA-1000SYS-ANALYTES IMMUNOGLOBULIN K833402 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Jan 1984. https://www.510kdatabase.net/k833794/ 1984-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k833794-lyphochek-therapeutic-drug-control-fda-510k.jpg K833794 - LYPHOCHEK THERAPEUTIC DRUG CONTROL K833794 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Jan 1984. https://www.510kdatabase.net/k833925/ 1984-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k833925-coat-a-count-nhs-prolactin-kit-and-fda-510k.jpg K833925 - COAT-A-COUNT NHS-PROLACTIN KIT AND K833925 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jan 1984. https://www.510kdatabase.net/k833959/ 1984-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k833959-microlab-m-diluterdispenser-fda-510k.jpg K833959 - MICROLAB M DILUTER/DISPENSER K833959 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jan 1984. https://www.510kdatabase.net/k833992/ 1984-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k833992-technicon-ra-1000-system-fda-510k.jpg K833992 - TECHNICON RA-1000 SYSTEM K833992 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Jan 1984. https://www.510kdatabase.net/k834052/ 1984-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k834052-chemkit-carbamazepine-diagnostic-kit-fda-510k.jpg K834052 - CHEMKIT CARBAMAZEPINE DIAGNOSTIC KIT K834052 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Jan 1984. https://www.510kdatabase.net/k834216/ 1984-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k834216-emit-qst-phenobarbital-assay-fda-510k.jpg K834216 - EMIT QST PHENOBARBITAL ASSAY K834216 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jan 1984. https://www.510kdatabase.net/k834604/ 1984-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k834604-c3-antiserum-control-fda-510k.jpg K834604 - C3 ANTISERUM CONTROL K834604 is a FDA 510(k) cleared immunology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Jan 1984. https://www.510kdatabase.net/k834605/ 1984-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k834605-c4-antigen-antibody-control-fda-510k.jpg K834605 - C4 ANTIGEN ANTIBODY CONTROL K834605 is a FDA 510(k) cleared immunology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Jan 1984. https://www.510kdatabase.net/k833772/ 1984-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k833772-auto-aic-analyzer-system-fda-510k.jpg K833772 - AUTO AIC ANALYZER SYSTEM K833772 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Jan 1984. https://www.510kdatabase.net/k833833/ 1984-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k833833-kodak-ektachem-700-analyzer-fda-510k.jpg K833833 - KODAK EKTACHEM 700 ANALYZER K833833 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Jan 1984. https://www.510kdatabase.net/k834302/ 1984-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k834302-stayfree-deodorant-maxi-pads-fda-510k.jpg K834302 - STAYFREE* DEODORANT MAXI-PADS K834302 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jan 1984. https://www.510kdatabase.net/k833701/ 1984-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k833701-aca-thyroxine-analytical-test-pack-fda-510k.jpg K833701 - ACA THYROXINE ANALYTICAL TEST PACK K833701 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Jan 1984. https://www.510kdatabase.net/k833746/ 1984-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k833746-tech-ra-1000-sys-serum-chloride-fda-510k.jpg K833746 - TECH. RA-1000 SYS SERUM CHLORIDE K833746 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Jan 1984. https://www.510kdatabase.net/k833807/ 1984-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k833807-argyle-jet-tracheal-tube-fda-510k.jpg K833807 - ARGYLE JET TRACHEAL TUBE K833807 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sherwood Medical Co.. Cleared Jan 1984. https://www.510kdatabase.net/k834107/ 1984-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k834107-angioplasty-inflation-device-cartr-fda-510k.jpg K834107 - ANGIOPLASTY INFLATION DEVICE & CARTR K834107 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Jan 1984. https://www.510kdatabase.net/k834456/ 1984-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k834456-helena-bio-strip-ob-fda-510k.jpg K834456 - HELENA BIO STRIP OB K834456 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Jan 1984. https://www.510kdatabase.net/k833791/ 1984-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k833791-syva-advance-digoxin-assay-fda-510k.jpg K833791 - SYVA ADVANCE DIGOXIN ASSAY K833791 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jan 1984. https://www.510kdatabase.net/k833505/ 1984-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k833505-il-model-840-microprocessor-loader-fda-510k.jpg K833505 - IL MODEL 840 MICROPROCESSOR LOADER K833505 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jan 1984. https://www.510kdatabase.net/k833967/ 1984-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k833967-cva-fda-510k.jpg K833967 - CVA K833967 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Jan 1984. https://www.510kdatabase.net/k833764/ 1984-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k833764-sterilization-of-gore-tex-soft-tissu-fda-510k.jpg K833764 - STERILIZATION OF GORE-TEX SOFT TISSU K833764 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Jan 1984. https://www.510kdatabase.net/k831516/ 1984-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k831516-gore-tex-surgical-membrane-fda-510k.jpg K831516 - GORE-TEX SURGICAL MEMBRANE K831516 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Jan 1984. https://www.510kdatabase.net/k833639/ 1984-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k833639-titangel-high-resolution-control-fda-510k.jpg K833639 - TITANGEL HIGH RESOLUTION CONTROL K833639 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Jan 1984. https://www.510kdatabase.net/k833702/ 1984-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k833702-aca-thyroxine-uptake-calibrator-fda-510k.jpg K833702 - ACA THYROXINE UPTAKE CALIBRATOR K833702 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Jan 1984. https://www.510kdatabase.net/k833841/ 1984-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k833841-il-test-igg-iga-igm-kits-fda-510k.jpg K833841 - IL TEST IGG IGA & IGM KITS K833841 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jan 1984. https://www.510kdatabase.net/k834066/ 1984-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k834066-tinsdale-enrichment-fda-510k.jpg K834066 - TINSDALE ENRICHMENT K834066 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Jan 1984. https://www.510kdatabase.net/k831710/ 1984-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k831710-bard-absorption-dressing-fda-510k.jpg K831710 - BARD ABSORPTION DRESSING K831710 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 1984. https://www.510kdatabase.net/k832580/ 1984-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k832580-raaf-catheter-repair-kit-fda-510k.jpg K832580 - RAAF CATHETER REPAIR KIT K832580 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Quinton, Inc.. Cleared Jan 1984. https://www.510kdatabase.net/k832774/ 1984-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k832774-repair-kits-for-right-atrial-cath-fda-510k.jpg K832774 - REPAIR KITS FOR RIGHT ATRIAL CATH K832774 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Quinton, Inc.. Cleared Jan 1984. https://www.510kdatabase.net/k833955/ 1984-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k833955-novel-dispenserpackage-fda-510k.jpg K833955 - NOVEL DISPENSER/PACKAGE K833955 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jan 1984. https://www.510kdatabase.net/k834067/ 1984-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k834067-legionella-differentiation-disk-fda-510k.jpg K834067 - LEGIONELLA DIFFERENTIATION DISK K834067 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Jan 1984. https://www.510kdatabase.net/k834068/ 1984-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k834068-ceb-fda-510k.jpg K834068 - CEB K834068 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Jan 1984. https://www.510kdatabase.net/k834204/ 1984-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k834204-middlebrook-cohn-7h11-agar-base-fda-510k.jpg K834204 - MIDDLEBROOK & COHN 7H11 AGAR BASE K834204 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Jan 1984. https://www.510kdatabase.net/k834205/ 1984-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k834205-middlebrook-cohn-7h10-agar-base-fda-510k.jpg K834205 - MIDDLEBROOK & COHN 7H10 AGAR BASE K834205 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Jan 1984. https://www.510kdatabase.net/k834206/ 1984-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k834206-eugonic-agar-fda-510k.jpg K834206 - EUGONIC AGAR K834206 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Jan 1984. https://www.510kdatabase.net/k832965/ 1983-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k832965-stratus-theophylline-assay-fda-510k.jpg K832965 - STRATUS THEOPHYLLINE ASSAY K832965 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Dec 1983. https://www.510kdatabase.net/k833083/ 1983-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k833083-derma-strip-tm-skin-closures-fda-510k.jpg K833083 - DERMA STRIP-TM SKIN CLOSURES K833083 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Howmedica Corp.. Cleared Dec 1983. https://www.510kdatabase.net/k833963/ 1983-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k833963-haemophilus-identification-test-kit-fda-510k.jpg K833963 - HAEMOPHILUS IDENTIFICATION TEST KIT K833963 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Dec 1983. https://www.510kdatabase.net/k833968/ 1983-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k833968-10b-fda-510k.jpg K833968 - 10B K833968 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Dec 1983. https://www.510kdatabase.net/k834022/ 1983-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k834022-pvp-iodine-fda-510k.jpg K834022 - PVP IODINE K834022 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Dec 1983. https://www.510kdatabase.net/k834028/ 1983-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k834028-bio-ornithine-fda-510k.jpg K834028 - BIO-ORNITHINE K834028 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Dec 1983. https://www.510kdatabase.net/k834029/ 1983-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k834029-bio-urea-fda-510k.jpg K834029 - BIO-UREA K834029 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Dec 1983. https://www.510kdatabase.net/k831507/ 1983-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k831507-low-trauma-arterial-filter-h-640-fda-510k.jpg K831507 - LOW TRAUMA ARTERIAL FILTER H-640 K831507 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 1983. https://www.510kdatabase.net/k832284/ 1983-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k832284-solution-admin-set-2c9096-w10-pvc-fda-510k.jpg K832284 - SOLUTION ADMIN. SET 2C9096 W/10 PVC K832284 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Dec 1983. https://www.510kdatabase.net/k833434/ 1983-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k833434-ceramco-high-fusing-foil-solder-fda-510k.jpg K833434 - CERAMCO * HIGH FUSING FOIL SOLDER K833434 is a FDA 510(k) cleared dental medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Dec 1983. https://www.510kdatabase.net/k833655/ 1983-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k833655-gillette-sabre-syringe-fda-510k.jpg K833655 - GILLETTE SABRE SYRINGE K833655 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Intermedics, Inc.. Cleared Dec 1983. https://www.510kdatabase.net/k833718/ 1983-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k833718-etching-gel-fda-510k.jpg K833718 - ETCHING GEL K833718 is a FDA 510(k) cleared dental medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Dec 1983. https://www.510kdatabase.net/k833776/ 1983-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k833776-qea-sodiumpotassium-analyzer-fda-510k.jpg K833776 - QEA SODIUM/POTASSIUM ANALYZER K833776 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Dec 1983. https://www.510kdatabase.net/k833932/ 1983-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k833932-syva-advance-cortisol-assay-fda-510k.jpg K833932 - SYVA ADVANCE CORTISOL ASSAY K833932 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Dec 1983. https://www.510kdatabase.net/k833958/ 1983-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k833958-flo-gard-8100-infusion-pump-fda-510k.jpg K833958 - FLO-GARD 8100 INFUSION PUMP K833958 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Dec 1983. https://www.510kdatabase.net/k832285/ 1983-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k832285-volumetric-pump-set-2c9100-for-nitrogly-fda-510k.jpg K832285 - VOLUMETRIC PUMP SET 2C9100 FOR NITROGLY K832285 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Dec 1983. https://www.510kdatabase.net/k832607/ 1983-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k832607-open-end-spring-guide-fda-510k.jpg K832607 - OPEN END SPRING GUIDE K832607 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 1983. https://www.510kdatabase.net/k833308/ 1983-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k833308-dual-lumen-needle-fda-510k.jpg K833308 - DUAL LUMEN NEEDLE K833308 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quinton, Inc.. Cleared Dec 1983. https://www.510kdatabase.net/k833378/ 1983-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k833378-n-acetylprocainamide-aca-analytical-fda-510k.jpg K833378 - N-ACETYLPROCAINAMIDE ACA-ANALYTICAL K833378 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Dec 1983. https://www.510kdatabase.net/k833379/ 1983-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k833379-lidocaine-analytical-test-pack-aca-fda-510k.jpg K833379 - LIDOCAINE ANALYTICAL TEST PACK ACA K833379 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Dec 1983. https://www.510kdatabase.net/k833380/ 1983-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k833380-lidoaine-calibrator-fda-510k.jpg K833380 - LIDOAINE CALIBRATOR K833380 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Dec 1983. https://www.510kdatabase.net/k833381/ 1983-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k833381-valproic-acid-analytical-test-pack-fda-510k.jpg K833381 - VALPROIC ACID ANALYTICAL TEST PACK K833381 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Dec 1983. https://www.510kdatabase.net/k833382/ 1983-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k833382-valproic-acid-calibrator-fda-510k.jpg K833382 - VALPROIC ACID CALIBRATOR K833382 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Dec 1983. https://www.510kdatabase.net/k833383/ 1983-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k833383-procainamide-calibrator-fda-510k.jpg K833383 - PROCAINAMIDE CALIBRATOR K833383 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Dec 1983. https://www.510kdatabase.net/k833384/ 1983-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k833384-procainamide-analytical-test-pack-fda-510k.jpg K833384 - PROCAINAMIDE ANALYTICAL TEST PACK K833384 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Dec 1983. https://www.510kdatabase.net/k833461/ 1983-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k833461-hs4-headneck-femoral-prostheses-fda-510k.jpg K833461 - HS4 HEAD/NECK FEMORAL PROSTHESES K833461 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Dec 1983. https://www.510kdatabase.net/k833473/ 1983-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k833473-dentin-bonding-agent-fda-510k.jpg K833473 - DENTIN BONDING AGENT K833473 is a FDA 510(k) cleared dental medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Dec 1983. https://www.510kdatabase.net/k833512/ 1983-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k833512-partial-denture-alloy-fda-510k.jpg K833512 - PARTIAL DENTURE ALLOY K833512 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Dec 1983. https://www.510kdatabase.net/k833683/ 1983-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k833683-chem-kit-theophylline-diag-kit-fda-510k.jpg K833683 - CHEM KIT THEOPHYLLINE DIAG. KIT K833683 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Dec 1983. https://www.510kdatabase.net/k833684/ 1983-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k833684-ivex-int-fda-510k.jpg K833684 - IVEX-INT K833684 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Dec 1983. https://www.510kdatabase.net/k833700/ 1983-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k833700-aca-thyroxine-calibrator-fda-510k.jpg K833700 - ACA THYROXINE CALIBRATOR K833700 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Dec 1983. https://www.510kdatabase.net/k833715/ 1983-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k833715-emit-netilmicin-assay-fda-510k.jpg K833715 - EMIT NETILMICIN ASSAY K833715 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Dec 1983. https://www.510kdatabase.net/k833740/ 1983-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k833740-venoset-multi-med-piggyback-wivex-2-fda-510k.jpg K833740 - VENOSET MULTI-MED PIGGYBACK W/IVEX-2 K833740 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Dec 1983. https://www.510kdatabase.net/k833749/ 1983-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k833749-peritoneal-catheter-changes--fda-510k.jpg K833749 - PERITONEAL CATHETER-CHANGES- K833749 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quinton, Inc.. Cleared Dec 1983. https://www.510kdatabase.net/k834065/ 1983-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k834065-a3b-fda-510k.jpg K834065 - A3B K834065 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Dec 1983. https://www.510kdatabase.net/k833175/ 1983-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k833175-biomet-bipolar-prosthesis-fda-510k.jpg K833175 - BIOMET BIPOLAR PROSTHESIS K833175 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Dec 1983. https://www.510kdatabase.net/k833353/ 1983-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k833353-aclaim-qap-ibm-personal-computer-edt-fda-510k.jpg K833353 - ACLAIM-QAP IBM PERSONAL COMPUTER EDT K833353 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Dec 1983. https://www.510kdatabase.net/k833411/ 1983-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k833411-knee-prosthesis-patella-component-fda-510k.jpg K833411 - KNEE PROSTHESIS-PATELLA COMPONENT K833411 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Dec 1983. https://www.510kdatabase.net/k833634/ 1983-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k833634-emit-methofrexate-assay-fda-510k.jpg K833634 - EMIT & METHOFREXATE ASSAY K833634 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Dec 1983. https://www.510kdatabase.net/k833741/ 1983-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k833741-venoset-multi-med-dual-rate-piggyback-fda-510k.jpg K833741 - VENOSET MULTI MED DUAL RATE PIGGYBACK K833741 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Dec 1983. https://www.510kdatabase.net/k833912/ 1983-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k833912-galante-fiber-metal-total-hip-fda-510k.jpg K833912 - GALANTE FIBER METAL TOTAL HIP K833912 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Dec 1983. https://www.510kdatabase.net/k833328/ 1983-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k833328-respironics-rescue-dome-fda-510k.jpg K833328 - RESPIRONICS RESCUE DOME K833328 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Dec 1983. https://www.510kdatabase.net/k833385/ 1983-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k833385-n-acetylprocainamide-calibrator-fda-510k.jpg K833385 - N-ACETYLPROCAINAMIDE CALIBRATOR K833385 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Dec 1983. https://www.510kdatabase.net/k833479/ 1983-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k833479-william-harvey-h-71-5-f-cardiotomy-fda-510k.jpg K833479 - WILLIAM HARVEY H-71-5-F CARDIOTOMY K833479 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 1983. https://www.510kdatabase.net/k833965/ 1983-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k833965-8-french-dilator-15cm-wluer-lock-fda-510k.jpg K833965 - 8 FRENCH DILATOR 15CM, W/LUER LOCK K833965 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Dec 1983. https://www.510kdatabase.net/k834031/ 1983-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k834031-factor-ii-deficient-substrate-plasma-fda-510k.jpg K834031 - FACTOR II DEFICIENT SUBSTRATE PLASMA K834031 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Dec 1983. https://www.510kdatabase.net/k834096/ 1983-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k834096-implantable-pulse-generator-fda-510k.jpg K834096 - IMPLANTABLE PULSE GENERATOR K834096 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Dec 1983. https://www.510kdatabase.net/k833357/ 1983-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k833357-vydax-525-550-5100-fluorotelomer-fda-510k.jpg K833357 - VYDAX 525-550 & 5100 FLUOROTELOMER K833357 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Dec 1983. https://www.510kdatabase.net/k833675/ 1983-12-12 monthly 0.5 https://www.510kdatabase.net/og-image/k833675-brigham-tibial-cement-pressurizer-fda-510k.jpg K833675 - BRIGHAM TIBIAL CEMENT PRESSURIZER K833675 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Dec 1983. https://www.510kdatabase.net/k833157/ 1983-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k833157-lancer-analyzer-cups-fda-510k.jpg K833157 - LANCER ANALYZER CUPS K833157 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sherwood Medical Co.. Cleared Dec 1983. https://www.510kdatabase.net/k833475/ 1983-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k833475-capiject-sys-capillary-blood-collect-fda-510k.jpg K833475 - CAPIJECT SYS CAPILLARY BLOOD COLLECT K833475 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Terumo Medical Corp.. Cleared Dec 1983. https://www.510kdatabase.net/k833503/ 1983-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k833503-clirans-model-taf-15-hollow-fiber-fda-510k.jpg K833503 - CLIRANS MODEL TAF 15 HOLLOW FIBER K833503 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Terumo Medical Corp.. Cleared Dec 1983. https://www.510kdatabase.net/k833546/ 1983-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k833546-modification-of-emit-and-amikacin-assay-fda-510k.jpg K833546 - MODIFICATION OF EMIT AND AMIKACIN ASSAY K833546 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Dec 1983. https://www.510kdatabase.net/k833623/ 1983-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k833623-modif-of-emit-cad-disopyramide-assay-fda-510k.jpg K833623 - MODIF. OF EMIT CAD DISOPYRAMIDE ASSAY K833623 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Dec 1983. https://www.510kdatabase.net/k833748/ 1983-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k833748-rescue-valve-fda-510k.jpg K833748 - RESCUE VALVE K833748 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Dec 1983. https://www.510kdatabase.net/k833848/ 1983-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k833848-dual-lumen-subclavian-cannula-fda-510k.jpg K833848 - DUAL LUMEN SUBCLAVIAN CANNULA K833848 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Shiley, Inc.. Cleared Dec 1983. https://www.510kdatabase.net/k833253/ 1983-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k833253-shiley-m2000-membrane-oxygenator-fda-510k.jpg K833253 - SHILEY M2000 MEMBRANE OXYGENATOR K833253 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Dec 1983. https://www.510kdatabase.net/k833364/ 1983-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k833364-3m-scotchplate-ii-dispersive-electrode-fda-510k.jpg K833364 - 3M SCOTCHPLATE II DISPERSIVE ELECTRODE K833364 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3M Company. Cleared Nov 1983. https://www.510kdatabase.net/k833595/ 1983-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k833595-capd-ultraviolet-germicidal-exchange-fda-510k.jpg K833595 - CAPD ULTRAVIOLET GERMICIDAL EXCHANGE K833595 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Nov 1983. https://www.510kdatabase.net/k833648/ 1983-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k833648-ophthalmic-cautery-6821-hot-temp-s-fda-510k.jpg K833648 - OPHTHALMIC CAUTERY #6821-HOT-TEMP #'S K833648 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Nov 1983. https://www.510kdatabase.net/k832875/ 1983-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k832875-cordia-hs-fda-510k.jpg K832875 - CORDIA HS K832875 is a FDA 510(k) cleared immunology medical device. Manufacturer: Cordis Corp.. Cleared Nov 1983. https://www.510kdatabase.net/k833065/ 1983-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k833065-automatic-peritoneal-dialysis-cycler-fda-510k.jpg K833065 - AUTOMATIC PERITONEAL DIALYSIS CYCLER K833065 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Nov 1983. https://www.510kdatabase.net/k833291/ 1983-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k833291-jh-peptone-agar-fda-510k.jpg K833291 - JH PEPTONE AGAR K833291 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Nov 1983. https://www.510kdatabase.net/k833327/ 1983-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k833327-respironics-pr-valve-fda-510k.jpg K833327 - RESPIRONICS PR VALVE K833327 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Nov 1983. https://www.510kdatabase.net/k832746/ 1983-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k832746-dupont-linearization-module-fda-510k.jpg K832746 - DUPONT LINEARIZATION MODULE K832746 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Nov 1983. https://www.510kdatabase.net/k832795/ 1983-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k832795-heifetz-intracranial-aneurysm-clips-fda-510k.jpg K832795 - HEIFETZ INTRACRANIAL ANEURYSM CLIPS K832795 is a FDA 510(k) cleared neurology medical device. Manufacturer: Edward Weck, Inc.. Cleared Nov 1983. https://www.510kdatabase.net/k833082/ 1983-11-25 monthly 0.5 https://www.510kdatabase.net/og-image/k833082-reagent-set-triglycerides-gpo-fda-510k.jpg K833082 - REAGENT SET TRIGLYCERIDES GPO K833082 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Nov 1983. https://www.510kdatabase.net/k831447/ 1983-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k831447-capnometer-wnew-airway-adapter-47210a-fda-510k.jpg K831447 - CAPNOMETER W/NEW AIRWAY ADAPTER 47210A K831447 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Nov 1983. https://www.510kdatabase.net/k832864/ 1983-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k832864-coloscreen-vpi-fda-510k.jpg K832864 - COLOSCREEN V.P.I. K832864 is a FDA 510(k) cleared immunology medical device. Manufacturer: Helena Laboratories. Cleared Nov 1983. https://www.510kdatabase.net/k832922/ 1983-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k832922-travaspore-biological-indicator-fda-510k.jpg K832922 - TRAVASPORE BIOLOGICAL INDICATOR K832922 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Nov 1983. https://www.510kdatabase.net/k833113/ 1983-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k833113-reporting-integrator-3392a-fda-510k.jpg K833113 - REPORTING INTEGRATOR 3392A K833113 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Nov 1983. https://www.510kdatabase.net/k833530/ 1983-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k833530-digital-fluorographic-x-ray-system-fda-510k.jpg K833530 - DIGITAL FLUOROGRAPHIC X-RAY SYSTEM K833530 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Nov 1983. https://www.510kdatabase.net/k832914/ 1983-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k832914-prima-unipolar-cardiac-pulse-generat-fda-510k.jpg K832914 - PRIMA-UNIPOLAR CARDIAC PULSE GENERAT K832914 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Nov 1983. https://www.510kdatabase.net/k832992/ 1983-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k832992-soffban-orthopedic-padding-fda-510k.jpg K832992 - SOFFBAN ORTHOPEDIC PADDING K832992 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Nov 1983. https://www.510kdatabase.net/k833005/ 1983-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k833005-paramax-bilirubin-calibrators-fda-510k.jpg K833005 - PARAMAX BILIRUBIN CALIBRATORS K833005 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Nov 1983. https://www.510kdatabase.net/k833070/ 1983-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k833070-tdx-theophylline-fda-510k.jpg K833070 - TDX THEOPHYLLINE K833070 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1983. https://www.510kdatabase.net/k833072/ 1983-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k833072-technicon-ra-1000-sys-ise-module-fda-510k.jpg K833072 - TECHNICON RA-1000 SYS-ISE MODULE & K833072 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Nov 1983. https://www.510kdatabase.net/k833292/ 1983-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k833292-lactabacillus-agar-wo-tween80-fda-510k.jpg K833292 - LACTABACILLUS AGAR W/O TWEEN80 K833292 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Nov 1983. https://www.510kdatabase.net/k833515/ 1983-11-14 monthly 0.5 https://www.510kdatabase.net/og-image/k833515-bouins-solution-fda-510k.jpg K833515 - BOUINS SOLUTION K833515 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Nov 1983. https://www.510kdatabase.net/k831988/ 1983-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k831988-intravascular-catheter-fda-510k.jpg K831988 - INTRAVASCULAR CATHETER K831988 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 1983. https://www.510kdatabase.net/k833069/ 1983-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k833069-tdx-glucose-fda-510k.jpg K833069 - TDX GLUCOSE K833069 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1983. https://www.510kdatabase.net/k833299/ 1983-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k833299-brucella-agar-modified-fda-510k.jpg K833299 - BRUCELLA AGAR MODIFIED K833299 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Nov 1983. https://www.510kdatabase.net/k833300/ 1983-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k833300-sabouraud-bhi-agar-fda-510k.jpg K833300 - SABOURAUD BHI AGAR K833300 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Nov 1983. https://www.510kdatabase.net/k833409/ 1983-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k833409-monospherical-resurfacing-glenoid-pros-fda-510k.jpg K833409 - MONOSPHERICAL RESURFACING GLENOID PROS K833409 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Nov 1983. https://www.510kdatabase.net/k833410/ 1983-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k833410-monospherical-glenoid-prosth-keel-fda-510k.jpg K833410 - MONOSPHERICAL GLENOID PROSTH. KEEL K833410 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Nov 1983. https://www.510kdatabase.net/k833023/ 1983-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k833023-technicon-ra-1000-system-fda-510k.jpg K833023 - TECHNICON RA-1000 SYSTEM K833023 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Nov 1983. https://www.510kdatabase.net/k833127/ 1983-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k833127-argyle-nasal-cannula-fda-510k.jpg K833127 - ARGYLE NASAL CANNULA K833127 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sherwood Medical Co.. Cleared Nov 1983. https://www.510kdatabase.net/k833272/ 1983-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k833272-thromboplastin-fs-fda-510k.jpg K833272 - THROMBOPLASTIN - FS K833272 is a FDA 510(k) cleared hematology medical device. Manufacturer: American Dade. Cleared Nov 1983. https://www.510kdatabase.net/k833356/ 1983-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k833356-glyco-jee-cpmtrp-fda-510k.jpg K833356 - GLYCO-JE,E CPMTRP K833356 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Nov 1983. https://www.510kdatabase.net/k833389/ 1983-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k833389-medium-199-wearles-salts-wl-glutam-fda-510k.jpg K833389 - MEDIUM 199 W/EARLE'S SALTS W/L-GLUTAM K833389 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Nov 1983. https://www.510kdatabase.net/k833390/ 1983-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k833390-tyrodes-salt-solution-wsodium-bicar-fda-510k.jpg K833390 - TYRODE'S SALT SOLUTION W/SODIUM BICAR K833390 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Nov 1983. https://www.510kdatabase.net/k833391/ 1983-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k833391-lactalbumin-hydrolysate-med-whanks-fda-510k.jpg K833391 - LACTALBUMIN HYDROLYSATE MED. W/HANKS K833391 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Nov 1983. https://www.510kdatabase.net/k833392/ 1983-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k833392-waymouth-mb-7521-med-wl-glutamine-fda-510k.jpg K833392 - WAYMOUTH MB 752/1 MED. W/L-GLUTAMINE K833392 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Nov 1983. https://www.510kdatabase.net/k833393/ 1983-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k833393-iscoes-mod-dulbeccos-med-wglutam-fda-510k.jpg K833393 - ISCOE'S MOD. DULBECCO'S MED. W/GLUTAM K833393 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Nov 1983. https://www.510kdatabase.net/k833394/ 1983-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k833394-medium-199-whanks-salt-wl-glutamine-fda-510k.jpg K833394 - MEDIUM 199 W/HANK'S SALT W/L-GLUTAMINE K833394 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Nov 1983. https://www.510kdatabase.net/k833424/ 1983-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k833424-veigerts-iron-hematoxylin-stain-ht10-79-fda-510k.jpg K833424 - VEIGERT'S IRON HEMATOXYLIN STAIN-HT10-79 K833424 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Nov 1983. https://www.510kdatabase.net/k831307/ 1983-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k831307-pecor-85-french-iab-on-a-datascope-fda-510k.jpg K831307 - PECOR 8.5 FRENCH IAB ON A DATASCOPE K831307 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Nov 1983. https://www.510kdatabase.net/k831397/ 1983-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k831397-french-intra-aortic-95-balloon-on-kon-fda-510k.jpg K831397 - FRENCH INTRA-AORTIC 9.5 BALLOON ON KON K831397 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Nov 1983. https://www.510kdatabase.net/k831454/ 1983-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k831454-lastoband-adhesive-bandages-fda-510k.jpg K831454 - LASTOBAND ADHESIVE BANDAGES K831454 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Oct 1983. https://www.510kdatabase.net/k831776/ 1983-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k831776-capnograph-fda-510k.jpg K831776 - CAPNOGRAPH K831776 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Datascope Corp.. Cleared Oct 1983. https://www.510kdatabase.net/k832318/ 1983-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k832318-isolation-bag-3m-fda-510k.jpg K832318 - ISOLATION BAG 3M K832318 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3M Company. Cleared Oct 1983. https://www.510kdatabase.net/k832924/ 1983-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k832924-venous-reservoir-fda-510k.jpg K832924 - VENOUS RESERVOIR K832924 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Oct 1983. https://www.510kdatabase.net/k832966/ 1983-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k832966-flexiflo-enteral-feeding-tube-fda-510k.jpg K832966 - FLEXIFLO ENTERAL FEEDING TUBE K832966 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1983. https://www.510kdatabase.net/k833167/ 1983-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k833167-trichrome-stain-lg-solution-fda-510k.jpg K833167 - TRICHROME STAIN LG SOLUTION K833167 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Chemical Co.. Cleared Oct 1983. https://www.510kdatabase.net/k833273/ 1983-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k833273-masson-trichrome-stain-ht15-fda-510k.jpg K833273 - MASSON TRICHROME STAIN HT15 K833273 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Oct 1983. https://www.510kdatabase.net/k833388/ 1983-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k833388-iron-stain-procedure-ht20-fda-510k.jpg K833388 - IRON STAIN PROCEDURE HT20 K833388 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Oct 1983. https://www.510kdatabase.net/k832088/ 1983-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k832088-ames-tda-netilmicin-test-serum-fda-510k.jpg K832088 - AMES TDA NETILMICIN TEST & SERUM K832088 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Oct 1983. https://www.510kdatabase.net/k832355/ 1983-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k832355-crash-cart-fda-510k.jpg K832355 - CRASH CART K832355 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Quinton, Inc.. Cleared Oct 1983. https://www.510kdatabase.net/k832962/ 1983-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k832962-gas-chromatograph-5890a-fda-510k.jpg K832962 - GAS CHROMATOGRAPH 5890A K832962 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Hewlett-Packard Co.. Cleared Oct 1983. https://www.510kdatabase.net/k833003/ 1983-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k833003-paramax-salicylate-reagent-fda-510k.jpg K833003 - PARAMAX SALICYLATE REAGENT K833003 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Oct 1983. https://www.510kdatabase.net/k833088/ 1983-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k833088-spirometer-isolation-valve-8890-fda-510k.jpg K833088 - SPIROMETER ISOLATION VALVE #8890 K833088 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Oct 1983. https://www.510kdatabase.net/k833163/ 1983-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k833163-mem-eagle-wearles-salts-wiveaa-fda-510k.jpg K833163 - MEM-EAGLE W/EARLES SALTS W/IVEAA K833163 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Oct 1983. https://www.510kdatabase.net/k833165/ 1983-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k833165-fishers-med-for-leukemic-cells-mice-fda-510k.jpg K833165 - FISHERS MED. FOR LEUKEMIC CELLS-MICE K833165 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Oct 1983. https://www.510kdatabase.net/k833166/ 1983-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k833166-procedure-460-for-determ-of-chloride-fda-510k.jpg K833166 - PROCEDURE 460 FOR DETERM. OF CHLORIDE K833166 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Oct 1983. https://www.510kdatabase.net/k833168/ 1983-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k833168-mem-eagle-wearles-salts-wneaa-fda-510k.jpg K833168 - MEM-EAGLE-W/EARLES SALTS W/NEAA & K833168 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Oct 1983. https://www.510kdatabase.net/k833169/ 1983-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k833169-mem-wl-glutamine-wo-sodium-bicarbon-fda-510k.jpg K833169 - MEM W/L-GLUTAMINE W/O SODIUM BICARBON K833169 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Oct 1983. https://www.510kdatabase.net/k833199/ 1983-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k833199-silicone-rubber-isolation-sleeve-350-01-fda-510k.jpg K833199 - SILICONE RUBBER ISOLATION SLEEVE 350-01 K833199 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Oct 1983. https://www.510kdatabase.net/k833234/ 1983-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k833234-kodak-t-mat-l-film-so-387-fda-510k.jpg K833234 - KODAK T-MAT L FILM SO-387 K833234 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Oct 1983. https://www.510kdatabase.net/k833235/ 1983-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k833235-kodak-multiloader-ii-for-x-omatic-cass-fda-510k.jpg K833235 - KODAK MULTILOADER II FOR X-OMATIC CASS K833235 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Oct 1983. https://www.510kdatabase.net/k833296/ 1983-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k833296-sabouraud-dextrose-agar-emmons-fda-510k.jpg K833296 - SABOURAUD DEXTROSE AGAR, EMMONS K833296 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Oct 1983. https://www.510kdatabase.net/k833301/ 1983-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k833301-feeley-gorman-agar-fda-510k.jpg K833301 - FEELEY-GORMAN AGAR K833301 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Oct 1983. https://www.510kdatabase.net/k831274/ 1983-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k831274-wlectrocardiograph-ecg-7204-fda-510k.jpg K831274 - WLECTROCARDIOGRAPH ECG-7204 K831274 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Oct 1983. https://www.510kdatabase.net/k832164/ 1983-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k832164-coat-a-count-free-t3-ria-kit-fda-510k.jpg K832164 - COAT-A-COUNT FREE T3 RIA KIT K832164 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Oct 1983. https://www.510kdatabase.net/k832221/ 1983-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k832221-ybbott-cmv-total-ab-eia-fda-510k.jpg K832221 - YBBOTT CMV TOTAL AB EIA K832221 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1983. https://www.510kdatabase.net/k832809/ 1983-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k832809-accu-prep-programmable-auto-diluter-fda-510k.jpg K832809 - ACCU-PREP PROGRAMMABLE AUTO-DILUTER K832809 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Oct 1983. https://www.510kdatabase.net/k832982/ 1983-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k832982-aca-tobramycin-calibrator-fda-510k.jpg K832982 - ACA TOBRAMYCIN CALIBRATOR K832982 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Oct 1983. https://www.510kdatabase.net/k832985/ 1983-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k832985-tobramycin-analytical-test-pack-aca-fda-510k.jpg K832985 - TOBRAMYCIN ANALYTICAL TEST PACK-ACA K832985 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Oct 1983. https://www.510kdatabase.net/k833010/ 1983-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k833010-cin-agar-yersinia-selective-agar-fda-510k.jpg K833010 - CIN AGAR YERSINIA-SELECTIVE AGAR K833010 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1983. https://www.510kdatabase.net/k833136/ 1983-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k833136-clostridium-difficile-fda-510k.jpg K833136 - CLOSTRIDIUM DIFFICILE K833136 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1983. https://www.510kdatabase.net/k833164/ 1983-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k833164-l-15-leibovitz-wl-glutamine-l4386-fda-510k.jpg K833164 - L-15-LEIBOVITZ W/L-GLUTAMINE-L4386 K833164 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Oct 1983. https://www.510kdatabase.net/k833198/ 1983-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k833198-silicone-rubber-isolation-sleeve-351-01-fda-510k.jpg K833198 - SILICONE RUBBER ISOLATION SLEEVE 351-01 K833198 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Oct 1983. https://www.510kdatabase.net/k833201/ 1983-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k833201-simmons-citrate-agar-fda-510k.jpg K833201 - SIMMONS CITRATE AGAR K833201 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Oct 1983. https://www.510kdatabase.net/k833202/ 1983-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k833202-moeller-decarboxylase-broth-fda-510k.jpg K833202 - MOELLER DECARBOXYLASE BROTH K833202 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Oct 1983. https://www.510kdatabase.net/k833203/ 1983-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k833203-deoxycholate-lactose-agar-fda-510k.jpg K833203 - DEOXYCHOLATE LACTOSE AGAR K833203 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Oct 1983. https://www.510kdatabase.net/k833204/ 1983-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k833204-deoxycholate-citrate-agar-fda-510k.jpg K833204 - DEOXYCHOLATE CITRATE AGAR K833204 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Oct 1983. https://www.510kdatabase.net/k833205/ 1983-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k833205-yersinia-selective-agar-fda-510k.jpg K833205 - YERSINIA SELECTIVE AGAR K833205 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Oct 1983. https://www.510kdatabase.net/k833206/ 1983-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k833206-tech-agar-fda-510k.jpg K833206 - TECH AGAR K833206 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Oct 1983. https://www.510kdatabase.net/k833207/ 1983-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k833207-ak-agar-2-fda-510k.jpg K833207 - AK AGAR 2 K833207 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Oct 1983. https://www.510kdatabase.net/k833208/ 1983-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k833208-mr-vp-broth-fda-510k.jpg K833208 - MR-VP BROTH K833208 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Oct 1983. https://www.510kdatabase.net/k833209/ 1983-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k833209-acidicase-bb1-fda-510k.jpg K833209 - ACIDICASE-BB1 K833209 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Oct 1983. https://www.510kdatabase.net/k833210/ 1983-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k833210-lactose-fda-510k.jpg K833210 - LACTOSE K833210 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Oct 1983. https://www.510kdatabase.net/k833211/ 1983-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k833211-bile-salts-mixture-fda-510k.jpg K833211 - BILE SALTS MIXTURE K833211 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Oct 1983. https://www.510kdatabase.net/k833212/ 1983-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k833212-mac-conkey-agar-without-crystal-violet-fda-510k.jpg K833212 - MAC CONKEY AGAR WITHOUT CRYSTAL VIOLET K833212 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Oct 1983. https://www.510kdatabase.net/k833213/ 1983-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k833213-kligler-iron-agar-fda-510k.jpg K833213 - KLIGLER IRON AGAR K833213 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Oct 1983. https://www.510kdatabase.net/k833214/ 1983-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k833214-dextrose-fda-510k.jpg K833214 - DEXTROSE K833214 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Oct 1983. https://www.510kdatabase.net/k833215/ 1983-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k833215-beef-extract-fda-510k.jpg K833215 - BEEF EXTRACT K833215 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Oct 1983. https://www.510kdatabase.net/k833216/ 1983-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k833216-motility-test-medium-fda-510k.jpg K833216 - MOTILITY TEST MEDIUM K833216 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Oct 1983. https://www.510kdatabase.net/k833217/ 1983-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k833217-standard-method-broth-fda-510k.jpg K833217 - STANDARD METHOD BROTH K833217 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Oct 1983. https://www.510kdatabase.net/k833218/ 1983-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k833218-yeast-beef-agar-antibiotic-med4-fda-510k.jpg K833218 - YEAST BEEF AGAR-ANTIBIOTIC MED.4 K833218 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Oct 1983. https://www.510kdatabase.net/k833219/ 1983-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k833219-staphylococcus-agar-10-fda-510k.jpg K833219 - STAPHYLOCOCCUS AGAR 10 K833219 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Oct 1983. https://www.510kdatabase.net/k833220/ 1983-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k833220-lowenstein-jensen-medium-base-fda-510k.jpg K833220 - LOWENSTEIN-JENSEN MEDIUM BASE K833220 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Oct 1983. https://www.510kdatabase.net/k831854/ 1983-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k831854-usci-angiographic-balloon-catheter-fda-510k.jpg K831854 - USCI ANGIOGRAPHIC BALLOON CATHETER K831854 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 1983. https://www.510kdatabase.net/k831894/ 1983-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k831894-blood-oxygenator-5070-fda-510k.jpg K831894 - BLOOD OXYGENATOR 5070 K831894 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Oct 1983. https://www.510kdatabase.net/k832428/ 1983-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k832428-platelet-aggregation-reagent-set-fda-510k.jpg K832428 - PLATELET AGGREGATION REAGENT SET K832428 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Oct 1983. https://www.510kdatabase.net/k832784/ 1983-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k832784-ultra-light-raaf-catheter-fda-510k.jpg K832784 - ULTRA LIGHT RAAF CATHETER K832784 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Oct 1983. https://www.510kdatabase.net/k833114/ 1983-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k833114-oxford-mark-2-external-fixator-fda-510k.jpg K833114 - OXFORD MARK 2 EXTERNAL FIXATOR K833114 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Oct 1983. https://www.510kdatabase.net/k831865/ 1983-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k831865-ionescu-shiley-low-porosity-composite-fda-510k.jpg K831865 - IONESCU-SHILEY LOW POROSITY COMPOSITE K831865 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Oct 1983. https://www.510kdatabase.net/k831880/ 1983-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k831880-ionescu-shiley-low-porosity-aortic-graft-fda-510k.jpg K831880 - IONESCU-SHILEY LOW POROSITY AORTIC GRAFT K831880 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Oct 1983. https://www.510kdatabase.net/k831895/ 1983-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k831895-blood-oxygenator-50-70s-fda-510k.jpg K831895 - BLOOD OXYGENATOR 50 70/S K831895 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Oct 1983. https://www.510kdatabase.net/k831943/ 1983-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k831943-patient-monitor-788-33a-fda-510k.jpg K831943 - PATIENT MONITOR 788 33A K831943 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Oct 1983. https://www.510kdatabase.net/k831944/ 1983-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k831944-patient-monitor-78832a-fda-510k.jpg K831944 - PATIENT MONITOR #78832A K831944 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Oct 1983. https://www.510kdatabase.net/k832386/ 1983-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k832386-percluder-dl-occluding-balloon-fda-510k.jpg K832386 - PERCLUDER DL OCCLUDING BALLOON K832386 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Oct 1983. https://www.510kdatabase.net/k832561/ 1983-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k832561-epcor-multielectrode-temp-pervenous-fda-510k.jpg K832561 - EPCOR MULTIELECTRODE TEMP. PERVENOUS K832561 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Oct 1983. https://www.510kdatabase.net/k833247/ 1983-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k833247-quantaphase-b-12-cobalmin-folate--fda-510k.jpg K833247 - QUANTAPHASE B-12-COBALMIN-FOLATE- K833247 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Oct 1983. https://www.510kdatabase.net/k831987/ 1983-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k831987-epsilon-ige-test-kit-fda-510k.jpg K831987 - EPSILON IGE TEST KIT K831987 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Oct 1983. https://www.510kdatabase.net/k832136/ 1983-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k832136-dual-flow-needle-fda-510k.jpg K832136 - DUAL FLOW NEEDLE K832136 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Oct 1983. https://www.510kdatabase.net/k832360/ 1983-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k832360-abbott-ige-eia-fda-510k.jpg K832360 - ABBOTT IGE EIA K832360 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1983. https://www.510kdatabase.net/k832375/ 1983-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k832375-liquid-chromatograph-1090-series-fda-510k.jpg K832375 - LIQUID CHROMATOGRAPH 1090 SERIES K832375 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Oct 1983. https://www.510kdatabase.net/k832515/ 1983-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k832515-cefuroxime-30-mcg-sensi-disc-fda-510k.jpg K832515 - CEFUROXIME 30 MCG SENSI-DISC K832515 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1983. https://www.510kdatabase.net/k832708/ 1983-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k832708-paramax-calcium-reagent-glutamy-trans-fda-510k.jpg K832708 - PARAMAX CALCIUM REAGENT-GLUTAMY-TRANS K832708 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Oct 1983. https://www.510kdatabase.net/k832790/ 1983-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k832790-seralyzer-astsgot-reagent-strips-fda-510k.jpg K832790 - SERALYZER AST/SGOT REAGENT STRIPS K832790 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Oct 1983. https://www.510kdatabase.net/k832791/ 1983-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k832791-serayzer-altsgpt-reagent-strips-fda-510k.jpg K832791 - SERAYZER ALT/SGPT REAGENT STRIPS K832791 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Oct 1983. https://www.510kdatabase.net/k832798/ 1983-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k832798-modifica-of-emit-aed-primidone-assay-fda-510k.jpg K832798 - MODIFICA-OF EMIT AED PRIMIDONE ASSAY K832798 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Oct 1983. https://www.510kdatabase.net/k832799/ 1983-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k832799-modifica-of-emit-cad-lidocaine-assay-fda-510k.jpg K832799 - MODIFICA- OF EMIT CAD LIDOCAINE ASSAY K832799 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Oct 1983. https://www.510kdatabase.net/k832822/ 1983-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k832822-closed-sys-drainage-bags-trays-fda-510k.jpg K832822 - CLOSED SYS. DRAINAGE BAGS & TRAYS K832822 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medline Industries, Inc.. Cleared Oct 1983. https://www.510kdatabase.net/k832899/ 1983-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k832899-zimmer-ossimeter-fda-510k.jpg K832899 - ZIMMER OSSIMETER K832899 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Zimmer, Inc.. Cleared Oct 1983. https://www.510kdatabase.net/k832956/ 1983-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k832956-ceftizolime-30-mcg-sensi-disc-fda-510k.jpg K832956 - CEFTIZOLIME 30 MCG SENSI-DISC K832956 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1983. https://www.510kdatabase.net/k833001/ 1983-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k833001-paramax-glutamytransferase-reagent-fda-510k.jpg K833001 - PARAMAX & GLUTAMYTRANSFERASE REAGENT K833001 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Oct 1983. https://www.510kdatabase.net/k833002/ 1983-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k833002-paramax-phosphorus-reagent-fda-510k.jpg K833002 - PARAMAX PHOSPHORUS REAGENT K833002 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Oct 1983. https://www.510kdatabase.net/k833004/ 1983-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k833004-paramax-total-bilirubin-reagent-fda-510k.jpg K833004 - PARAMAX TOTAL BILIRUBIN REAGENT K833004 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Oct 1983. https://www.510kdatabase.net/k833015/ 1983-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k833015-bioplar-cord-disposable-30-1538-fda-510k.jpg K833015 - BIOPLAR CORD -DISPOSABLE 30-1538 K833015 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Oct 1983. https://www.510kdatabase.net/k833071/ 1983-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k833071-technicon-paracut-fda-510k.jpg K833071 - TECHNICON PARACUT K833071 is a FDA 510(k) cleared pathology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Oct 1983. https://www.510kdatabase.net/k831633/ 1983-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k831633-quantum-bipolar-cardiac-pulse-generator-fda-510k.jpg K831633 - QUANTUM BIPOLAR CARDIAC PULSE GENERATOR K831633 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Oct 1983. https://www.510kdatabase.net/k831962/ 1983-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k831962-chlamydiazyme-enzyme-immunoassay-detec-fda-510k.jpg K831962 - CHLAMYDIAZYME, ENZYME IMMUNOASSAY DETEC K831962 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1983. https://www.510kdatabase.net/k832684/ 1983-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k832684-seralyzer-triglycerides-reagent-strips-fda-510k.jpg K832684 - SERALYZER TRIGLYCERIDES REAGENT STRIPS K832684 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Oct 1983. https://www.510kdatabase.net/k832695/ 1983-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k832695-lyphochek-serum-ref-standard-bovine-fda-510k.jpg K832695 - LYPHOCHEK SERUM REF. STANDARD-BOVINE K832695 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Oct 1983. https://www.510kdatabase.net/k832719/ 1983-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k832719-emit-aed-valproic-acid-assay-fda-510k.jpg K832719 - EMIT AED VALPROIC ACID ASSAY K832719 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Oct 1983. https://www.510kdatabase.net/k832720/ 1983-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k832720-emit-aed-carbamazepine-assay-fda-510k.jpg K832720 - EMIT AED CARBAMAZEPINE ASSAY K832720 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Oct 1983. https://www.510kdatabase.net/k832958/ 1983-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k832958-freeman-acetabular-cup-fda-510k.jpg K832958 - FREEMAN ACETABULAR CUP K832958 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Oct 1983. https://www.510kdatabase.net/k830361/ 1983-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k830361-mms-acetabular-cups-fda-510k.jpg K830361 - MMS ACETABULAR CUPS K830361 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 3M Company. Cleared Sep 1983. https://www.510kdatabase.net/k831512/ 1983-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k831512-dosimetry-release-of-radiation-steriliz-fda-510k.jpg K831512 - DOSIMETRY RELEASE OF RADIATION STERILIZ K831512 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Sep 1983. https://www.510kdatabase.net/k831787/ 1983-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k831787-patient-monitor-78353a-fda-510k.jpg K831787 - PATIENT MONITOR #78353A K831787 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Sep 1983. https://www.510kdatabase.net/k832044/ 1983-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k832044-shiley-multipro-catheter-fda-510k.jpg K832044 - SHILEY MULTIPRO CATHETER K832044 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Sep 1983. https://www.510kdatabase.net/k832077/ 1983-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k832077-micro-trak-chlamydia-trachomatis-direct-fda-510k.jpg K832077 - MICRO TRAK CHLAMYDIA TRACHOMATIS DIRECT K832077 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Syva Co.. Cleared Sep 1983. https://www.510kdatabase.net/k832078/ 1983-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k832078-micro-trak-chlamydia-trac-control-slid-fda-510k.jpg K832078 - MICRO TRAK CHLAMYDIA TRAC CONTROL SLID K832078 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Syva Co.. Cleared Sep 1983. https://www.510kdatabase.net/k832079/ 1983-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k832079-collection-kit-chlamydia-trachomatis-fda-510k.jpg K832079 - COLLECTION KIT CHLAMYDIA TRACHOMATIS K832079 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Syva Co.. Cleared Sep 1983. https://www.510kdatabase.net/k832228/ 1983-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k832228-rubascan-latex-card-test-fda-510k.jpg K832228 - RUBASCAN LATEX CARD TEST K832228 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1983. https://www.510kdatabase.net/k832704/ 1983-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k832704-shiley-gas-filter-fda-510k.jpg K832704 - SHILEY GAS FILTER K832704 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Sep 1983. https://www.510kdatabase.net/k832726/ 1983-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k832726-intrinsic-factor-blocking-antibody-kit-fda-510k.jpg K832726 - INTRINSIC FACTOR BLOCKING ANTIBODY KIT K832726 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Sep 1983. https://www.510kdatabase.net/k832766/ 1983-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k832766-ames-tda-disopyramide-test-fda-510k.jpg K832766 - AMES TDA DISOPYRAMIDE TEST K832766 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Sep 1983. https://www.510kdatabase.net/k832769/ 1983-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k832769-ames-tda-kanamycin-test-control-serum-fda-510k.jpg K832769 - AMES TDA KANAMYCIN TEST-CONTROL SERUM K832769 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Sep 1983. https://www.510kdatabase.net/k832775/ 1983-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k832775-a-gent-glycosylated-hemoglobin-fda-510k.jpg K832775 - A-GENT GLYCOSYLATED HEMOGLOBIN K832775 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1983. https://www.510kdatabase.net/k832792/ 1983-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k832792-ames-tda-sisomicin-test-control-serum-fda-510k.jpg K832792 - AMES TDA SISOMICIN TEST-CONTROL SERUM K832792 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Sep 1983. https://www.510kdatabase.net/k832797/ 1983-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k832797-modifica-of-emit-aed-ethosuximide-assay-fda-510k.jpg K832797 - MODIFICA- OF EMIT AED ETHOSUXIMIDE ASSAY K832797 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Sep 1983. https://www.510kdatabase.net/k832834/ 1983-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k832834-concise-2-small-particle-light-curved-fda-510k.jpg K832834 - CONCISE 2 SMALL PARTICLE LIGHT CURVED K832834 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Sep 1983. https://www.510kdatabase.net/k832835/ 1983-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k832835-dulbeccos-phosphate-buffered-saline-fda-510k.jpg K832835 - DULBECCOS PHOSPHATE BUFFERED SALINE K832835 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Sep 1983. https://www.510kdatabase.net/k832836/ 1983-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k832836-basal-med-b9763-whanks-salts-wl-g-fda-510k.jpg K832836 - BASAL MED. #B9763 W/HANKS SALTS W/L-G K832836 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Sep 1983. https://www.510kdatabase.net/k832841/ 1983-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k832841-nutrient-mixture-f12-n6760-wl-glutam-fda-510k.jpg K832841 - NUTRIENT MIXTURE F12 #N6760 W/L-GLUTAM K832841 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Sep 1983. https://www.510kdatabase.net/k832842/ 1983-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k832842-dulbeccos-modified-eagles-medium-d5648-fda-510k.jpg K832842 - DULBECCOS MODIFIED EAGLES MEDIUM D5648 K832842 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Sep 1983. https://www.510kdatabase.net/k832929/ 1983-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k832929-ristocetin-platelet-aggrega-reagent-test-fda-510k.jpg K832929 - RISTOCETIN PLATELET AGGREGA-REAGENT TEST K832929 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Sep 1983. https://www.510kdatabase.net/k832930/ 1983-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k832930-spinner-salt-solution-s-6011-wearles-fda-510k.jpg K832930 - SPINNER SALT SOLUTION S-6011 W/EARLES K832930 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Sep 1983. https://www.510kdatabase.net/k832953/ 1983-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k832953-mucicarmine-stain-ht30-fda-510k.jpg K832953 - MUCICARMINE STAIN, #HT30 K832953 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Sep 1983. https://www.510kdatabase.net/k832954/ 1983-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k832954-v-agar-fda-510k.jpg K832954 - V AGAR K832954 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1983. https://www.510kdatabase.net/k832955/ 1983-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k832955-bacteroides-bile-esculin-agar-fda-510k.jpg K832955 - BACTEROIDES BILE ESCULIN AGAR K832955 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1983. https://www.510kdatabase.net/k831930/ 1983-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k831930-toxo-screen-da-test-fda-510k.jpg K831930 - TOXO-SCREEN DA TEST K831930 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1983. https://www.510kdatabase.net/k831991/ 1983-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k831991-directigen-group-b-strep-test-kit-serum-fda-510k.jpg K831991 - DIRECTIGEN GROUP B STREP TEST KIT-SERUM K831991 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1983. https://www.510kdatabase.net/k832246/ 1983-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k832246-dupont-isolator-15-microbial-tube-fda-510k.jpg K832246 - DUPONT ISOLATOR 1.5 MICROBIAL TUBE K832246 is a FDA 510(k) cleared microbiology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Sep 1983. https://www.510kdatabase.net/k832286/ 1983-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k832286-cerestore-core-material-fda-510k.jpg K832286 - CERESTORE CORE MATERIAL K832286 is a FDA 510(k) cleared dental medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Sep 1983. https://www.510kdatabase.net/k832406/ 1983-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k832406-quantum-ii-yeast-ident-system-fda-510k.jpg K832406 - QUANTUM II YEAST IDENT. SYSTEM K832406 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1983. https://www.510kdatabase.net/k832655/ 1983-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k832655-ecolyzer-200cohb-analyzer-sys-fda-510k.jpg K832655 - ECOLYZER #200/COHB ANALYZER SYS K832655 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1983. https://www.510kdatabase.net/k832837/ 1983-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k832837-nutrient-mixture-f-10-n6635-wl-gluta-fda-510k.jpg K832837 - NUTRIENT MIXTURE F-10 #N6635 W/L-GLUTA K832837 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Sep 1983. https://www.510kdatabase.net/k832838/ 1983-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k832838-earles-balanced-salt-mixture-e6132-fda-510k.jpg K832838 - EARLES BALANCED SALT MIXTURE #E6132 K832838 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Sep 1983. https://www.510kdatabase.net/k832839/ 1983-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k832839-hanks-balanced-salt-mixture-h6136-fda-510k.jpg K832839 - HANKS BALANCED SALT MIXTURE H6136 K832839 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Sep 1983. https://www.510kdatabase.net/k832840/ 1983-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k832840-minimum-essential-med-eagle-m4642-w-fda-510k.jpg K832840 - MINIMUM ESSENTIAL MED. EAGLE M4642 W/ K832840 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Sep 1983. https://www.510kdatabase.net/k832881/ 1983-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k832881-advantage-series-contoured-lumbo-sacar-fda-510k.jpg K832881 - ADVANTAGE SERIES CONTOURED LUMBO SACAR K832881 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Depuy, Inc.. Cleared Sep 1983. https://www.510kdatabase.net/k831972/ 1983-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k831972-epsilon-tsh-test-kit-fda-510k.jpg K831972 - EPSILON TSH TEST KIT K831972 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Sep 1983. https://www.510kdatabase.net/k831982/ 1983-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k831982-bradford-spinal-fracture-fixation-sys-fda-510k.jpg K831982 - BRADFORD SPINAL FRACTURE FIXATION SYS K831982 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Sep 1983. https://www.510kdatabase.net/k832132/ 1983-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k832132-sera-tek-mycoplasma-antibody-test-fda-510k.jpg K832132 - SERA-TEK MYCOPLASMA ANTIBODY TEST K832132 is a FDA 510(k) cleared immunology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Sep 1983. https://www.510kdatabase.net/k832811/ 1983-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k832811-shiley-3l-cardf-plus-fda-510k.jpg K832811 - SHILEY 3L CARDF PLUS K832811 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Sep 1983. https://www.510kdatabase.net/k831708/ 1983-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k831708-micro-structured-surface-hip-prosthesis-fda-510k.jpg K831708 - MICRO-STRUCTURED SURFACE HIP PROSTHESIS K831708 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Sep 1983. https://www.510kdatabase.net/k831534/ 1983-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k831534-pumpette-as8p-infusion-pump-fda-510k.jpg K831534 - PUMPETTE AS8P-INFUSION PUMP K831534 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Sep 1983. https://www.510kdatabase.net/k831788/ 1983-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k831788-urodynamic-analyzer-fda-510k.jpg K831788 - URODYNAMIC ANALYZER K831788 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Sep 1983. https://www.510kdatabase.net/k831886/ 1983-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k831886-femoral-canal-sponge-fda-510k.jpg K831886 - FEMORAL CANAL SPONGE K831886 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Zimmer, Inc.. Cleared Sep 1983. https://www.510kdatabase.net/k831934/ 1983-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k831934-theophylline-test-pack-aca-fda-510k.jpg K831934 - THEOPHYLLINE TEST PACK ACA K831934 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Sep 1983. https://www.510kdatabase.net/k832289/ 1983-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k832289-lifecare-micro-pump-fda-510k.jpg K832289 - LIFECARE MICRO PUMP K832289 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1983. https://www.510kdatabase.net/k832410/ 1983-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k832410-graseby-dynamics-ms302-syringe-driver-fda-510k.jpg K832410 - GRASEBY DYNAMICS MS302 SYRINGE DRIVER K832410 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Intermedics, Inc.. Cleared Sep 1983. https://www.510kdatabase.net/k832447/ 1983-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k832447-stratus-carbamazepine-flurometric-fda-510k.jpg K832447 - STRATUS CARBAMAZEPINE FLUROMETRIC K832447 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Sep 1983. https://www.510kdatabase.net/k832457/ 1983-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k832457-a-gent-phenobarbital-fda-510k.jpg K832457 - A-GENT PHENOBARBITAL K832457 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1983. https://www.510kdatabase.net/k832496/ 1983-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k832496-bio-sure-stain-fda-510k.jpg K832496 - BIO SURE STAIN K832496 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Sep 1983. https://www.510kdatabase.net/k832504/ 1983-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k832504-cronex-lo-dose-mammography-fda-510k.jpg K832504 - CRONEX LO-DOSE MAMMOGRAPHY K832504 is a FDA 510(k) cleared radiology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Sep 1983. https://www.510kdatabase.net/k832568/ 1983-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k832568-indole-nitrate-medium-fda-510k.jpg K832568 - INDOLE NITRATE MEDIUM K832568 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Sep 1983. https://www.510kdatabase.net/k832569/ 1983-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k832569-infusion-broth-fda-510k.jpg K832569 - INFUSION BROTH K832569 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Sep 1983. https://www.510kdatabase.net/k832570/ 1983-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k832570-extract-broth-fda-510k.jpg K832570 - EXTRACT BROTH K832570 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Sep 1983. https://www.510kdatabase.net/k832571/ 1983-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k832571-bile-esculin-azide-agar-fda-510k.jpg K832571 - BILE ESCULIN AZIDE AGAR K832571 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Sep 1983. https://www.510kdatabase.net/k832572/ 1983-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k832572-bile-esculin-agar-fda-510k.jpg K832572 - BILE ESCULIN AGAR K832572 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Sep 1983. https://www.510kdatabase.net/k832573/ 1983-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k832573-cled-medium-fda-510k.jpg K832573 - C.L.E.D. MEDIUM K832573 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Sep 1983. https://www.510kdatabase.net/k832574/ 1983-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k832574-btb-lactose-agar-fda-510k.jpg K832574 - BTB LACTOSE AGAR K832574 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Sep 1983. https://www.510kdatabase.net/k832575/ 1983-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k832575-antibiotic-assay-broth-fda-510k.jpg K832575 - ANTIBIOTIC ASSAY BROTH K832575 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Sep 1983. https://www.510kdatabase.net/k832576/ 1983-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k832576-base-agar-fda-510k.jpg K832576 - BASE AGAR K832576 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Sep 1983. https://www.510kdatabase.net/k832577/ 1983-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k832577-seed-agar-fda-510k.jpg K832577 - SEED AGAR K832577 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Sep 1983. https://www.510kdatabase.net/k832627/ 1983-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k832627-technicon-h6000-system-fda-510k.jpg K832627 - TECHNICON H6000 SYSTEM K832627 is a FDA 510(k) cleared hematology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Sep 1983. https://www.510kdatabase.net/k832631/ 1983-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k832631-a-gent-carbamazepine-fda-510k.jpg K832631 - A-GENT CARBAMAZEPINE K832631 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1983. https://www.510kdatabase.net/k832663/ 1983-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k832663-gamma-steril-capillary-flow-dialy-g15-fda-510k.jpg K832663 - GAMMA STERIL. CAPILLARY FLOW DIALY-G15 K832663 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Sep 1983. https://www.510kdatabase.net/k832683/ 1983-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k832683-monoject-injectomatic-fda-510k.jpg K832683 - MONOJECT INJECTOMATIC K832683 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Sep 1983. https://www.510kdatabase.net/k832687/ 1983-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k832687-basal-med-eagle-b9888-wl-glutamine-fda-510k.jpg K832687 - BASAL MED. EAGLE #B9888 W/L-GLUTAMINE K832687 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Sep 1983. https://www.510kdatabase.net/k832688/ 1983-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k832688-dulbeccos-modified-eagle-d5523--fda-510k.jpg K832688 - DULBECCO'S MODIFIED EAGLE #D5523- K832688 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Sep 1983. https://www.510kdatabase.net/k832689/ 1983-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k832689-mccoys-5a-m4892-wl-glutamine-and-fda-510k.jpg K832689 - MCCOY'S 5A #M4892 W/L-GLUTAMINE AND K832689 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Sep 1983. https://www.510kdatabase.net/k832690/ 1983-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k832690-minimum-essential-med-eagle-m0268-fda-510k.jpg K832690 - MINIMUM ESSENTIAL MED. EAGLE M0268 K832690 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Sep 1983. https://www.510kdatabase.net/k832718/ 1983-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k832718-emit-cad-procainamide-assay-fda-510k.jpg K832718 - EMIT CAD PROCAINAMIDE ASSAY K832718 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Sep 1983. https://www.510kdatabase.net/k831600/ 1983-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k831600-diastix-reagent-strips-for-urinalysis-fda-510k.jpg K831600 - DIASTIX REAGENT STRIPS FOR URINALYSIS K831600 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Sep 1983. https://www.510kdatabase.net/k831441/ 1983-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k831441-porocoat-freemansamuelson-total-knee-fda-510k.jpg K831441 - POROCOAT FREEMAN/SAMUELSON TOTAL KNEE K831441 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Sep 1983. https://www.510kdatabase.net/k832292/ 1983-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k832292-solo-tach-fda-510k.jpg K832292 - SOLO-TACH K832292 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Sep 1983. https://www.510kdatabase.net/k832357/ 1983-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k832357-aca-total-bilirubin-analytical-test-pak-fda-510k.jpg K832357 - ACA TOTAL BILIRUBIN ANALYTICAL TEST PAK K832357 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Sep 1983. https://www.510kdatabase.net/k832419/ 1983-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k832419-a-gent-pherytoin-fda-510k.jpg K832419 - A-GENT PHERYTOIN K832419 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1983. https://www.510kdatabase.net/k832420/ 1983-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k832420-facs-analyzer-fda-510k.jpg K832420 - FACS ANALYZER K832420 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1983. https://www.510kdatabase.net/k832061/ 1983-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k832061-light-curing-bonding-agent-fda-510k.jpg K832061 - LIGHT CURING BONDING AGENT K832061 is a FDA 510(k) cleared dental medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Aug 1983. https://www.510kdatabase.net/k832062/ 1983-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k832062-adapticfast-set-dental-restorative-fda-510k.jpg K832062 - ADAPTIC*FAST SET DENTAL RESTORATIVE K832062 is a FDA 510(k) cleared dental medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Aug 1983. https://www.510kdatabase.net/k832236/ 1983-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k832236-sigma-procedure-550-determ-bilirub-fda-510k.jpg K832236 - SIGMA PROCEDURE #550 DETERM. BILIRUB K832236 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Aug 1983. https://www.510kdatabase.net/k832238/ 1983-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k832238-neuromod-comfort-wave-7721-dual--fda-510k.jpg K832238 - NEUROMOD COMFORT WAVE #7721 DUAL- K832238 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Aug 1983. https://www.510kdatabase.net/k832291/ 1983-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k832291-auto-tach-fda-510k.jpg K832291 - AUTO-TACH K832291 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Aug 1983. https://www.510kdatabase.net/k832320/ 1983-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k832320-prisma-iii-fda-510k.jpg K832320 - PRISMA III K832320 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Aug 1983. https://www.510kdatabase.net/k832336/ 1983-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k832336-stratus-amikacin-fluorometric-fda-510k.jpg K832336 - STRATUS AMIKACIN FLUOROMETRIC K832336 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Aug 1983. https://www.510kdatabase.net/k832445/ 1983-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k832445-stratus-gentamicin-fluorometric-enzym-fda-510k.jpg K832445 - STRATUS GENTAMICIN FLUOROMETRIC ENZYM K832445 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Aug 1983. https://www.510kdatabase.net/k832578/ 1983-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k832578-monojet-samplette-adapters-fda-510k.jpg K832578 - MONOJET SAMPLETTE ADAPTERS K832578 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sherwood Medical Co.. Cleared Aug 1983. https://www.510kdatabase.net/k832595/ 1983-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k832595-vessel-dilator-fda-510k.jpg K832595 - VESSEL DILATOR K832595 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1983. https://www.510kdatabase.net/k831373/ 1983-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k831373-pca-hip-system-fda-510k.jpg K831373 - P.C.A. HIP SYSTEM K831373 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Aug 1983. https://www.510kdatabase.net/k832252/ 1983-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k832252-clirans-taf06-hollow-fiber-dialyzer-fda-510k.jpg K832252 - CLIRANS TAF06 HOLLOW FIBER DIALYZER K832252 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Terumo Medical Corp.. Cleared Aug 1983. https://www.510kdatabase.net/k832408/ 1983-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k832408-stratus-tobramycin-fluorometric-enzym-fda-510k.jpg K832408 - STRATUS TOBRAMYCIN FLUOROMETRIC ENZYM K832408 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Aug 1983. https://www.510kdatabase.net/k832059/ 1983-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k832059-ionophorelic-sweat-stim-chloride--fda-510k.jpg K832059 - IONOPHORELIC SWEAT STIM. CHLORIDE- K832059 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Medtronic Vascular. Cleared Aug 1983. https://www.510kdatabase.net/k832087/ 1983-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k832087-titan-gel-glyco-heme-system-fda-510k.jpg K832087 - TITAN GEL GLYCO-HEME SYSTEM K832087 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Aug 1983. https://www.510kdatabase.net/k832251/ 1983-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k832251-preciset-cholesterol-high-perform-fda-510k.jpg K832251 - PRECISET CHOLESTEROL HIGH PERFORM K832251 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Aug 1983. https://www.510kdatabase.net/k832398/ 1983-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k832398-dynacor-connecting-tubing-fda-510k.jpg K832398 - DYNACOR CONNECTING TUBING K832398 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Aug 1983. https://www.510kdatabase.net/k837776/ 1983-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k837776-aor-x-ray-aligment-pad-fda-510k.jpg K837776 - AOR X-RAY ALIGMENT PAD K837776 is a FDA 510(k) cleared radiology medical device. Manufacturer: Zimmer, Inc.. Cleared Aug 1983. https://www.510kdatabase.net/k831143/ 1983-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k831143-pca-unicompartmental-knee-prosthes-fda-510k.jpg K831143 - P.C.A. UNICOMPARTMENTAL KNEE PROSTHES K831143 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Aug 1983. https://www.510kdatabase.net/k831668/ 1983-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k831668-continu-flo-solution-administration-fda-510k.jpg K831668 - CONTINU-FLO SOLUTION ADMINISTRATION K831668 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Aug 1983. https://www.510kdatabase.net/k832158/ 1983-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k832158-cholesterol-high-performance-k-fda-510k.jpg K832158 - CHOLESTEROL HIGH PERFORMANCE-K K832158 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Aug 1983. https://www.510kdatabase.net/k832166/ 1983-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k832166-flo-gard-8500-microinfusion-pump-fda-510k.jpg K832166 - FLO-GARD 8500 MICROINFUSION PUMP K832166 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Aug 1983. https://www.510kdatabase.net/k832175/ 1983-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k832175-digilab-350-the-krakau-perimeter-fda-510k.jpg K832175 - DIGILAB 350 THE KRAKAU PERIMETER K832175 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Bio-Rad. Cleared Aug 1983. https://www.510kdatabase.net/k830806/ 1983-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k830806-vascular-graftbifurcatedfep-ringed-fda-510k.jpg K830806 - VASCULAR GRAFT/BIFURCATED/FEP-RINGED K830806 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Aug 1983. https://www.510kdatabase.net/k831873/ 1983-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k831873-bone-screw-fda-510k.jpg K831873 - BONE SCREW K831873 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Aug 1983. https://www.510kdatabase.net/k832098/ 1983-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k832098-n-acetylprocainamide-assay-for-cobas-fda-510k.jpg K832098 - N-ACETYLPROCAINAMIDE ASSAY FOR COBAS K832098 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Aug 1983. https://www.510kdatabase.net/k832120/ 1983-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k832120-prominjet-pump-fda-510k.jpg K832120 - PROMINJET PUMP K832120 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1983. https://www.510kdatabase.net/k832123/ 1983-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k832123-venipuncture-valve-fda-510k.jpg K832123 - VENIPUNCTURE VALVE K832123 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1983. https://www.510kdatabase.net/k832163/ 1983-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k832163-sopheia-digoxin-eia-kit-fda-510k.jpg K832163 - SOPHEIA DIGOXIN EIA KIT K832163 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Aug 1983. https://www.510kdatabase.net/k832178/ 1983-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k832178-amplatz-heparin-coated-catheter-fda-510k.jpg K832178 - AMPLATZ HEPARIN COATED CATHETER K832178 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Aug 1983. https://www.510kdatabase.net/k832181/ 1983-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k832181-sno-strips-sterile-tearflow-test-strip-fda-510k.jpg K832181 - SNO STRIPS STERILE TEARFLOW TEST STRIP K832181 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Aug 1983. https://www.510kdatabase.net/k832229/ 1983-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k832229-bbl-anagel-powder-fda-510k.jpg K832229 - BBL ANAGEL POWDER K832229 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1983. https://www.510kdatabase.net/k832382/ 1983-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k832382-carefree-panty-shields-regdeor-fda-510k.jpg K832382 - CAREFREE * PANTY SHIELDS-REG/DEOR K832382 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Aug 1983. https://www.510kdatabase.net/k832409/ 1983-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k832409-lifeline-pacing-leads-471-07-09-fda-510k.jpg K832409 - LIFELINE PACING LEADS #471-07 &09 K832409 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Aug 1983. https://www.510kdatabase.net/k831746/ 1983-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k831746-pisces-3487-epidural-lead-for-spinal-fda-510k.jpg K831746 - PISCES #3487 EPIDURAL LEAD FOR SPINAL K831746 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Aug 1983. https://www.510kdatabase.net/k831852/ 1983-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k831852-fetal-monitor-115-fda-510k.jpg K831852 - FETAL MONITOR #115 K831852 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Aug 1983. https://www.510kdatabase.net/k831978/ 1983-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k831978-emit-serum-tricyclic-antidepressent-fda-510k.jpg K831978 - EMIT SERUM TRICYCLIC ANTIDEPRESSENT K831978 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Aug 1983. https://www.510kdatabase.net/k832046/ 1983-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k832046-seralyzer-multicomponent-calibrators-fda-510k.jpg K832046 - SERALYZER MULTICOMPONENT CALIBRATORS K832046 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Aug 1983. https://www.510kdatabase.net/k832097/ 1983-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k832097-phenobartial-assay-use-on-cobas-bio-fda-510k.jpg K832097 - PHENOBARTIAL ASSAY USE ON COBAS-BIO K832097 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Aug 1983. https://www.510kdatabase.net/k832003/ 1983-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k832003-aqueous-blood-gas-control-level-iii-fda-510k.jpg K832003 - AQUEOUS BLOOD GAS CONTROL LEVEL I,II & K832003 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Aug 1983. https://www.510kdatabase.net/k830541/ 1983-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k830541-injection-sealing-cap-13791-fda-510k.jpg K830541 - INJECTION SEALING CAP 13791 K830541 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Quinton, Inc.. Cleared Aug 1983. https://www.510kdatabase.net/k831053/ 1983-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k831053-quantigen-t-b-cell-assay-fda-510k.jpg K831053 - QUANTIGEN T & B CELL ASSAY K831053 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Aug 1983. https://www.510kdatabase.net/k831457/ 1983-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k831457-auto-suture-poly-surgiclip-hemostatic-fda-510k.jpg K831457 - AUTO SUTURE POLY SURGICLIP HEMOSTATIC K831457 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Aug 1983. https://www.510kdatabase.net/k831940/ 1983-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k831940-gamma-sterilized-capillary-flow-dialyz-fda-510k.jpg K831940 - GAMMA STERILIZED CAPILLARY FLOW DIALYZ K831940 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Aug 1983. https://www.510kdatabase.net/k831989/ 1983-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k831989-visidex-ii-reagent-strips-fda-510k.jpg K831989 - VISIDEX II REAGENT STRIPS K831989 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Aug 1983. https://www.510kdatabase.net/k831994/ 1983-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k831994-biocheck-positive-urine-control-fda-510k.jpg K831994 - BIOCHECK POSITIVE URINE CONTROL K831994 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Aug 1983. https://www.510kdatabase.net/k832027/ 1983-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k832027-argyle-yankaver-suction-tube-wcontrol-fda-510k.jpg K832027 - ARGYLE YANKAVER SUCTION TUBE W/CONTROL K832027 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Aug 1983. https://www.510kdatabase.net/k832055/ 1983-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k832055-emit-assay-and-tobramycin-fda-510k.jpg K832055 - EMIT ASSAY AND TOBRAMYCIN K832055 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Aug 1983. https://www.510kdatabase.net/k832056/ 1983-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k832056-emit-amd-gentamicin-assay-fda-510k.jpg K832056 - EMIT AMD GENTAMICIN ASSAY K832056 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Aug 1983. https://www.510kdatabase.net/k832096/ 1983-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k832096-emit-cad-quinidine-assay-for-use-w-fda-510k.jpg K832096 - EMIT CAD QUINIDINE ASSAY FOR USE W/ K832096 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Aug 1983. https://www.510kdatabase.net/k832165/ 1983-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k832165-improved-silicath-silicone-elastomer-fda-510k.jpg K832165 - IMPROVED SILICATH SILICONE ELASTOMER K832165 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Aug 1983. https://www.510kdatabase.net/k832232/ 1983-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k832232-epineed-epidural-catheter-fda-510k.jpg K832232 - EPINEED EPIDURAL CATHETER K832232 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Terumo Medical Corp.. Cleared Aug 1983. https://www.510kdatabase.net/k832233/ 1983-08-08 monthly 0.5 https://www.510kdatabase.net/og-image/k832233-epineed-epidural-needle-fda-510k.jpg K832233 - EPINEED EPIDURAL NEEDLE K832233 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Terumo Medical Corp.. Cleared Aug 1983. https://www.510kdatabase.net/k832010/ 1983-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k832010-broncho-fiberscope-fda-510k.jpg K832010 - BRONCHO-FIBERSCOPE K832010 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Aug 1983. https://www.510kdatabase.net/k832033/ 1983-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k832033-emit-aed-phenytoin-assay-fda-510k.jpg K832033 - EMIT AED PHENYTOIN ASSAY K832033 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Aug 1983. https://www.510kdatabase.net/k832034/ 1983-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k832034-emit-aad-theophylline-assay-fda-510k.jpg K832034 - EMIT AAD THEOPHYLLINE ASSAY K832034 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Aug 1983. https://www.510kdatabase.net/k831249/ 1983-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k831249-pro-quantum-fda-510k.jpg K831249 - PRO QUANTUM K831249 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jul 1983. https://www.510kdatabase.net/k831313/ 1983-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k831313-tissue-tek-vip-100200-fda-510k.jpg K831313 - TISSUE-TEK V.I.P. 100/200 K831313 is a FDA 510(k) cleared pathology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Jul 1983. https://www.510kdatabase.net/k831513/ 1983-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k831513-kennedy-tibial-component-fda-510k.jpg K831513 - KENNEDY TIBIAL COMPONENT K831513 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jul 1983. https://www.510kdatabase.net/k831827/ 1983-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k831827-egg-yolk-agar-fda-510k.jpg K831827 - EGG YOLK AGAR K831827 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jul 1983. https://www.510kdatabase.net/k832099/ 1983-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k832099-medtronic-models-4012-4512-fda-510k.jpg K832099 - MEDTRONIC MODELS 4012 & 4512 K832099 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jul 1983. https://www.510kdatabase.net/k830927/ 1983-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k830927-knee-prosthesis-tibial-component-fda-510k.jpg K830927 - KNEE PROSTHESIS-TIBIAL COMPONENT K830927 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jul 1983. https://www.510kdatabase.net/k831744/ 1983-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k831744-transcutaneous-oxygen-monitor-option-fda-510k.jpg K831744 - TRANSCUTANEOUS OXYGEN MONITOR OPTION K831744 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Jul 1983. https://www.510kdatabase.net/k831933/ 1983-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k831933-theophylline-aca-calibrator-fda-510k.jpg K831933 - THEOPHYLLINE ACA CALIBRATOR K831933 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Jul 1983. https://www.510kdatabase.net/k831979/ 1983-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k831979-emit-serum-tricyclic-antidepress-contro-fda-510k.jpg K831979 - EMIT SERUM TRICYCLIC ANTIDEPRESS. CONTRO K831979 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jul 1983. https://www.510kdatabase.net/k831980/ 1983-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k831980-emit-serum-tricyclic-antidepress-calibra-fda-510k.jpg K831980 - EMIT SERUM TRICYCLIC ANTIDEPRESS CALIBRA K831980 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jul 1983. https://www.510kdatabase.net/k832048/ 1983-07-19 monthly 0.5 https://www.510kdatabase.net/og-image/k832048-astra-systems-enzyme-module-ld-p-fda-510k.jpg K832048 - ASTRA SYSTEMS ENZYME MODULE LD-P K832048 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jul 1983. https://www.510kdatabase.net/k831621/ 1983-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k831621-fluorets-sterile-ophth-strips-fda-510k.jpg K831621 - FLUORETS STERILE OPHTH. STRIPS K831621 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 1983. https://www.510kdatabase.net/k831705/ 1983-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k831705-wm-harvey-parallel-plate-membrane-blood-fda-510k.jpg K831705 - WM. HARVEY PARALLEL PLATE MEMBRANE BLOOD K831705 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jul 1983. https://www.510kdatabase.net/k831719/ 1983-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k831719-monojet-sps-blood-collection-tube-fda-510k.jpg K831719 - MONOJET SPS BLOOD COLLECTION TUBE K831719 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sherwood Medical Co.. Cleared Jul 1983. https://www.510kdatabase.net/k831742/ 1983-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k831742-quantimune-hfsh-ria-human-follicle--fda-510k.jpg K831742 - QUANTIMUNE HFSH RIA HUMAN FOLLICLE- K831742 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Jul 1983. https://www.510kdatabase.net/k831839/ 1983-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k831839-stainless-steel-guide-wire-fda-510k.jpg K831839 - STAINLESS STEEL GUIDE WIRE K831839 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Jul 1983. https://www.510kdatabase.net/k831974/ 1983-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k831974-stomach-tube-levin-tube-fda-510k.jpg K831974 - STOMACH TUBE LEVIN TUBE K831974 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medline Industries, Inc.. Cleared Jul 1983. https://www.510kdatabase.net/k832009/ 1983-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k832009-model-27224p-continuous-flow-pump-fda-510k.jpg K832009 - MODEL #27224P CONTINUOUS FLOW PUMP K832009 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jul 1983. https://www.510kdatabase.net/k832036/ 1983-07-18 monthly 0.5 https://www.510kdatabase.net/og-image/k832036-qea-sodiumpotassium-analyzer-fda-510k.jpg K832036 - QEA SODIUM/POTASSIUM ANALYZER K832036 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jul 1983. https://www.510kdatabase.net/k831128/ 1983-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k831128-bard-intramedullary-plug-fda-510k.jpg K831128 - BARD INTRAMEDULLARY PLUG K831128 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jul 1983. https://www.510kdatabase.net/k831314/ 1983-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k831314-interference-medullary-fit-imf-hip-fda-510k.jpg K831314 - INTERFERENCE MEDULLARY FIT -IMF-HIP K831314 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jul 1983. https://www.510kdatabase.net/k831392/ 1983-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k831392-tru-cut-biopsyaspira-needle-2n2709-fda-510k.jpg K831392 - TRU-CUT BIOPSY/ASPIRA-NEEDLE 2N2709 K831392 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Jul 1983. https://www.510kdatabase.net/k831610/ 1983-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k831610-intradiscal-therapy-needle-fda-510k.jpg K831610 - INTRADISCAL THERAPY NEEDLE K831610 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jul 1983. https://www.510kdatabase.net/k831603/ 1983-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k831603-titan-geieplate-fda-510k.jpg K831603 - TITAN GE/IEPLATE K831603 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Jul 1983. https://www.510kdatabase.net/k831720/ 1983-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k831720-argyle-silicone-trachestomy-tube-wlow-fda-510k.jpg K831720 - ARGYLE SILICONE TRACHESTOMY TUBE W/LOW K831720 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sherwood Medical Co.. Cleared Jul 1983. https://www.510kdatabase.net/k831704/ 1983-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k831704-technicon-h6000-system-control-fda-510k.jpg K831704 - TECHNICON H6000 SYSTEM CONTROL K831704 is a FDA 510(k) cleared hematology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Jul 1983. https://www.510kdatabase.net/k831745/ 1983-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k831745-basal-medium-eagle-wearles-salts-fda-510k.jpg K831745 - BASAL MEDIUM EAGLE W/EARLES SALTS, & K831745 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Jul 1983. https://www.510kdatabase.net/k830963/ 1983-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k830963-quinidine-reagent-test-kit-fda-510k.jpg K830963 - QUINIDINE REAGENT TEST KIT K830963 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jun 1983. https://www.510kdatabase.net/k831258/ 1983-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k831258-flo-gard-6100-volumetric-infusion-pump-fda-510k.jpg K831258 - FLO-GARD 6100 VOLUMETRIC INFUSION PUMP K831258 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Jun 1983. https://www.510kdatabase.net/k831332/ 1983-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k831332-argyle-dual-stage-venous-return-cath-fda-510k.jpg K831332 - ARGYLE DUAL STAGE VENOUS RETURN CATH. K831332 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sherwood Medical Co.. Cleared Jun 1983. https://www.510kdatabase.net/k831380/ 1983-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k831380-delton-light-curing-pit-fissure-fda-510k.jpg K831380 - DELTON LIGHT CURING PIT & FISSURE K831380 is a FDA 510(k) cleared dental medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jun 1983. https://www.510kdatabase.net/k831493/ 1983-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k831493-denture-adhesive-seals-fda-510k.jpg K831493 - DENTURE ADHESIVE SEALS K831493 is a FDA 510(k) cleared dental medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jun 1983. https://www.510kdatabase.net/k831514/ 1983-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k831514-amwa-tda-theophylline-test-fda-510k.jpg K831514 - AMWA TDA THEOPHYLLINE TEST K831514 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Jun 1983. https://www.510kdatabase.net/k831549/ 1983-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k831549-arm-slings-fda-510k.jpg K831549 - ARM SLINGS K831549 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jun 1983. https://www.510kdatabase.net/k831559/ 1983-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k831559-certain-dental-restorative-fda-510k.jpg K831559 - CERTAIN *DENTAL RESTORATIVE K831559 is a FDA 510(k) cleared dental medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jun 1983. https://www.510kdatabase.net/k831647/ 1983-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k831647-denture-relining-repairrebasing-resin-fda-510k.jpg K831647 - DENTURE RELINING, REPAIR/REBASING RESIN K831647 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jun 1983. https://www.510kdatabase.net/k831548/ 1983-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k831548-splints-fda-510k.jpg K831548 - SPLINTS K831548 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jun 1983. https://www.510kdatabase.net/k830314/ 1983-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k830314-milwaukee-austin-moore-total-hip-fda-510k.jpg K830314 - MILWAUKEE AUSTIN MOORE TOTAL HIP K830314 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jun 1983. https://www.510kdatabase.net/k831542/ 1983-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k831542-adjustable-polycentric-elbow-hinge-fda-510k.jpg K831542 - ADJUSTABLE POLYCENTRIC ELBOW HINGE K831542 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jun 1983. https://www.510kdatabase.net/k831543/ 1983-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k831543-adjust-weights-bk5171-051020-beok-fda-510k.jpg K831543 - ADJUST. WEIGHTS-BK5171-05,10,20 BEOK K831543 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jun 1983. https://www.510kdatabase.net/k831544/ 1983-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k831544-deluxe-traction-exercise-glove-bk5035-fda-510k.jpg K831544 - DELUXE TRACTION EXERCISE GLOVE BK5035 K831544 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jun 1983. https://www.510kdatabase.net/k831550/ 1983-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k831550-finger-boniometer-bk7506-fda-510k.jpg K831550 - FINGER BONIOMETER BK7506 K831550 is a FDA 510(k) cleared neurology medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jun 1983. https://www.510kdatabase.net/k830953/ 1983-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k830953-micro-trak-hsv1-2-culture-confirmation-fda-510k.jpg K830953 - MICRO TRAK HSV1 & 2 CULTURE CONFIRMATION K830953 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Syva Co.. Cleared Jun 1983. https://www.510kdatabase.net/k831478/ 1983-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k831478-lyphochek-hemoglobin-aic-control-human-fda-510k.jpg K831478 - LYPHOCHEK HEMOGLOBIN AIC CONTROL HUMAN K831478 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Jun 1983. https://www.510kdatabase.net/k831480/ 1983-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k831480-paramax-alkaline-phosphatase-reagent--fda-510k.jpg K831480 - PARAMAX ALKALINE PHOSPHATASE REAGENT- K831480 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Jun 1983. https://www.510kdatabase.net/k831518/ 1983-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k831518-auto-carousewash-solution-concentrate-fda-510k.jpg K831518 - AUTO CAROUSE/WASH SOLUTION CONCENTRATE K831518 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Jun 1983. https://www.510kdatabase.net/k831519/ 1983-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k831519-rpmi-1640-medium-wl-glutamine-fda-510k.jpg K831519 - RPMI-1640 MEDIUM W/L-GLUTAMINE & K831519 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Jun 1983. https://www.510kdatabase.net/k831537/ 1983-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k831537-paramax-creatine-kinase-reagent-fda-510k.jpg K831537 - PARAMAX CREATINE KINASE REAGENT K831537 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Jun 1983. https://www.510kdatabase.net/k831536/ 1983-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k831536-paramax-amaline-reagent-fda-510k.jpg K831536 - PARAMAX AMALINE REAGENT K831536 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Jun 1983. https://www.510kdatabase.net/k830753/ 1983-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k830753-needle-guide-model-21285a-fda-510k.jpg K830753 - NEEDLE GUIDE MODEL 21285A K830753 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Hewlett-Packard Co.. Cleared Jun 1983. https://www.510kdatabase.net/k830935/ 1983-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k830935-hemoglobin-alc-by-column-test-fda-510k.jpg K830935 - HEMOGLOBIN ALC BY COLUMN TEST K830935 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bio-Rad. Cleared Jun 1983. https://www.510kdatabase.net/k831417/ 1983-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k831417-emit-qst-tobramycin-control-fda-510k.jpg K831417 - EMIT QST TOBRAMYCIN CONTROL K831417 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jun 1983. https://www.510kdatabase.net/k831553/ 1983-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k831553-leg-drainage-bag-strap-bk6011-fda-510k.jpg K831553 - LEG DRAINAGE BAG STRAP BK6011 K831553 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jun 1983. https://www.510kdatabase.net/k830655/ 1983-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k830655-quik-silver-resting-ecg-electrode-fda-510k.jpg K830655 - QUIK-SILVER RESTING ECG ELECTRODE K830655 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Jun 1983. https://www.510kdatabase.net/k821178/ 1983-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k821178-ethicon-external-fixation-wire-fda-510k.jpg K821178 - ETHICON EXTERNAL FIXATION WIRE K821178 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Jun 1983. https://www.510kdatabase.net/k837506/ 1983-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k837506-kodak-t-mat-g-film-so-381-fda-510k.jpg K837506 - KODAK T-MAT G FILM SO-381 K837506 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Jun 1983. https://www.510kdatabase.net/k831055/ 1983-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k831055-hemoglobin-electrophoresis-meth-on-the--fda-510k.jpg K831055 - HEMOGLOBIN ELECTROPHORESIS METH ON THE- K831055 is a FDA 510(k) cleared hematology medical device. Manufacturer: Olympus Corp.. Cleared Jun 1983. https://www.510kdatabase.net/k831065/ 1983-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k831065-sectioning-aid-kit-fda-510k.jpg K831065 - SECTIONING AID KIT K831065 is a FDA 510(k) cleared pathology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Jun 1983. https://www.510kdatabase.net/k831140/ 1983-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k831140-dade-hematology-calibrator-fda-510k.jpg K831140 - DADE HEMATOLOGY CALIBRATOR K831140 is a FDA 510(k) cleared hematology medical device. Manufacturer: American Dade. Cleared Jun 1983. https://www.510kdatabase.net/k831297/ 1983-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k831297-prototroproteolytic-enzyme-control-fda-510k.jpg K831297 - PROTOTRO/PROTEOLYTIC ENZYME CONTROL K831297 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Jun 1983. https://www.510kdatabase.net/k831311/ 1983-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k831311-solution-admin-sets-wflashball-fda-510k.jpg K831311 - SOLUTION ADMIN. SETS W/FLASHBALL K831311 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Jun 1983. https://www.510kdatabase.net/k831353/ 1983-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k831353-astra-systems-enzyme-module-fda-510k.jpg K831353 - ASTRA SYSTEMS ENZYME MODULE K831353 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jun 1983. https://www.510kdatabase.net/k831416/ 1983-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k831416-emit-qst-tobramycin-assay-fda-510k.jpg K831416 - EMIT QST TOBRAMYCIN ASSAY K831416 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jun 1983. https://www.510kdatabase.net/k831538/ 1983-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k831538-deluxe-adjust-angle-board-bk4066-fda-510k.jpg K831538 - DELUXE ADJUST-ANGLE BOARD-BK4066 K831538 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jun 1983. https://www.510kdatabase.net/k831539/ 1983-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k831539-economy-plastic-sock-bk2084-aid-fda-510k.jpg K831539 - ECONOMY PLASTIC SOCK-BK2084-AID K831539 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jun 1983. https://www.510kdatabase.net/k831540/ 1983-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k831540-compressogrip-elastic-stump-shrinker-fda-510k.jpg K831540 - COMPRESSOGRIP ELASTIC STUMP SHRINKER# K831540 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jun 1983. https://www.510kdatabase.net/k831545/ 1983-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k831545-reacher-door-opener-fda-510k.jpg K831545 - REACHER & DOOR OPENER K831545 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jun 1983. https://www.510kdatabase.net/k831546/ 1983-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k831546-adaptive-pens-lap-desk-fda-510k.jpg K831546 - ADAPTIVE PENS & LAP DESK K831546 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jun 1983. https://www.510kdatabase.net/k831547/ 1983-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k831547-raised-toilet-seats-nail-clippers-fda-510k.jpg K831547 - RAISED TOILET SEATS & NAIL CLIPPERS K831547 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jun 1983. https://www.510kdatabase.net/k831552/ 1983-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k831552-sorbothane-visco-inner-sole-pad-fda-510k.jpg K831552 - SORBOTHANE VISCO INNER SOLE PAD K831552 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jun 1983. https://www.510kdatabase.net/k831551/ 1983-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k831551-compressogrip-tubular-elastic-bandage-fda-510k.jpg K831551 - COMPRESSOGRIP TUBULAR ELASTIC BANDAGE K831551 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jun 1983. https://www.510kdatabase.net/k831203/ 1983-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k831203-y-type-backcheck-microbore-exten-set-fda-510k.jpg K831203 - Y-TYPE BACKCHECK MICROBORE EXTEN. SET K831203 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1983. https://www.510kdatabase.net/k831233/ 1983-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k831233-glenoid-resurfacing-component-3m-10816-fda-510k.jpg K831233 - GLENOID RESURFACING COMPONENT-3M-10816 K831233 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 3M Company. Cleared Jun 1983. https://www.510kdatabase.net/k831482/ 1983-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k831482-clirans-taf-120-hollow-fiber-dialyz-fda-510k.jpg K831482 - CLIRANS TAF 120 HOLLOW FIBER DIALYZ. & K831482 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Terumo Medical Corp.. Cleared Jun 1983. https://www.510kdatabase.net/k830926/ 1983-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k830926-160260-suction-coagulator-fda-510k.jpg K830926 - 160/260 SUCTION COAGULATOR K830926 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Zimmer, Inc.. Cleared Jun 1983. https://www.510kdatabase.net/k830997/ 1983-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k830997-aria-ii-i-hcg-fda-510k.jpg K830997 - ARIA II I-HCG K830997 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jun 1983. https://www.510kdatabase.net/k831234/ 1983-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k831234-glenoid-resurface-component-pmn-3m-fda-510k.jpg K831234 - GLENOID RESURFACE COMPONENT PMN 3M K831234 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 3M Company. Cleared Jun 1983. https://www.510kdatabase.net/k831273/ 1983-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k831273-qst-tm-sample-processor-fda-510k.jpg K831273 - QST TM SAMPLE PROCESSOR K831273 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Jun 1983. https://www.510kdatabase.net/k831304/ 1983-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k831304-emit-qst-gentamicin-assay-fda-510k.jpg K831304 - EMIT QST GENTAMICIN ASSAY K831304 is a FDA 510(k) cleared immunology medical device. Manufacturer: Syva Co.. Cleared Jun 1983. https://www.510kdatabase.net/k831342/ 1983-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k831342-coat-a-count-no-extraction-testosterone-fda-510k.jpg K831342 - COAT-A-COUNT NO-EXTRACTION TESTOSTERONE K831342 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jun 1983. https://www.510kdatabase.net/k831355/ 1983-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k831355-emit-qst-quinidine-assay-fda-510k.jpg K831355 - EMIT QST QUINIDINE ASSAY K831355 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jun 1983. https://www.510kdatabase.net/k831399/ 1983-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k831399-ames-tda-n-acetyl-procainamide-test-fda-510k.jpg K831399 - AMES TDA N-ACETYL-PROCAINAMIDE TEST K831399 is a FDA 510(k) cleared immunology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Jun 1983. https://www.510kdatabase.net/k831400/ 1983-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k831400-ames-tda-procainamide-test-fda-510k.jpg K831400 - AMES TDA PROCAINAMIDE TEST K831400 is a FDA 510(k) cleared immunology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Jun 1983. https://www.510kdatabase.net/k831541/ 1983-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k831541-tub-transfer-bench-bk6481-fda-510k.jpg K831541 - TUB TRANSFER BENCH BK6481 K831541 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jun 1983. https://www.510kdatabase.net/k823487/ 1983-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k823487-bard-ureteral-stent-fda-510k.jpg K823487 - BARD URETERAL STENT K823487 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 1983. https://www.510kdatabase.net/k830646/ 1983-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k830646-directigen-neisseria-meningitidis-fda-510k.jpg K830646 - DIRECTIGEN NEISSERIA MENINGITIDIS K830646 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared May 1983. https://www.510kdatabase.net/k831141/ 1983-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k831141-emit-srd-manual-cortisol-assay-fda-510k.jpg K831141 - EMIT SRD MANUAL CORTISOL ASSAY K831141 is a FDA 510(k) cleared immunology medical device. Manufacturer: Syva Co.. Cleared May 1983. https://www.510kdatabase.net/k831178/ 1983-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k831178-coat-a-count-no-extraction-aldosterone-fda-510k.jpg K831178 - COAT-A-COUNT NO-EXTRACTION ALDOSTERONE K831178 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared May 1983. https://www.510kdatabase.net/k831185/ 1983-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k831185-cardiac-output-measure-system-fda-510k.jpg K831185 - CARDIAC OUTPUT MEASURE SYSTEM K831185 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared May 1983. https://www.510kdatabase.net/k831272/ 1983-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k831272-emit-qst-theophylline-assay-fda-510k.jpg K831272 - EMIT QST THEOPHYLLINE ASSAY K831272 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared May 1983. https://www.510kdatabase.net/k831324/ 1983-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k831324-eeg-422p-electro-encephalograph-fda-510k.jpg K831324 - EEG 42/2P ELECTRO ENCEPHALOGRAPH K831324 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared May 1983. https://www.510kdatabase.net/k831354/ 1983-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k831354-emit-qst-lidocaine-assay-fda-510k.jpg K831354 - EMIT QST LIDOCAINE ASSAY K831354 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared May 1983. https://www.510kdatabase.net/k823904/ 1983-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k823904-model-515-neo-trak-neonatal-monitor-fda-510k.jpg K823904 - MODEL 515 NEO-TRAK NEONATAL MONITOR K823904 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared May 1983. https://www.510kdatabase.net/k830313/ 1983-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k830313-cfe-total-hip-femoral-component-fda-510k.jpg K830313 - CFE TOTAL HIP FEMORAL COMPONENT K830313 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared May 1983. https://www.510kdatabase.net/k830758/ 1983-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k830758-azlin-azlocilin-sodium-diag-reagent-fda-510k.jpg K830758 - AZLIN AZLOCILIN SODIUM-DIAG. REAGENT K830758 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared May 1983. https://www.510kdatabase.net/k831122/ 1983-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k831122-william-harvey-h-1700-adult-blood-oxyg--fda-510k.jpg K831122 - WILLIAM HARVEY H-1700 ADULT BLOOD OXYG- K831122 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 1983. https://www.510kdatabase.net/k831210/ 1983-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k831210-gentamicin-test-pack-aca-fda-510k.jpg K831210 - GENTAMICIN TEST PACK-ACA K831210 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared May 1983. https://www.510kdatabase.net/k831367/ 1983-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k831367-pmn-volz-curettes-fda-510k.jpg K831367 - PMN VOLZ CURETTES K831367 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3M Company. Cleared May 1983. https://www.510kdatabase.net/k830674/ 1983-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k830674-mahurkar-femoral-catheter-fda-510k.jpg K830674 - MAHURKAR FEMORAL CATHETER K830674 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quinton, Inc.. Cleared May 1983. https://www.510kdatabase.net/k830794/ 1983-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k830794-argyle-maden-silicone-gastrostomy-tube-fda-510k.jpg K830794 - ARGYLE MADEN SILICONE GASTROSTOMY TUBE K830794 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Sherwood Medical Co.. Cleared May 1983. https://www.510kdatabase.net/k831107/ 1983-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k831107-coat-a-count-neonatal-t4-kit-ria-kit-fda-510k.jpg K831107 - COAT-A-COUNT NEONATAL T4 KIT RIA KIT K831107 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared May 1983. https://www.510kdatabase.net/k831177/ 1983-05-17 monthly 0.5 https://www.510kdatabase.net/og-image/k831177-stratus-digoxin-fluorometric-enzyme-imm--fda-510k.jpg K831177 - STRATUS DIGOXIN FLUOROMETRIC ENZYME IMM- K831177 is a FDA 510(k) cleared immunology medical device. Manufacturer: American Dade. Cleared May 1983. https://www.510kdatabase.net/k830209/ 1983-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k830209-lus-acetabular-component-fda-510k.jpg K830209 - LUS ACETABULAR COMPONENT K830209 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared May 1983. https://www.510kdatabase.net/k831105/ 1983-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k831105-cordia-pap-fda-510k.jpg K831105 - CORDIA PAP K831105 is a FDA 510(k) cleared immunology medical device. Manufacturer: Cordis Corp.. Cleared May 1983. https://www.510kdatabase.net/k831154/ 1983-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k831154-stratus-phenytoin-fluorometric-enzyme-fda-510k.jpg K831154 - STRATUS PHENYTOIN FLUOROMETRIC ENZYME K831154 is a FDA 510(k) cleared immunology medical device. Manufacturer: American Dade. Cleared May 1983. https://www.510kdatabase.net/k831209/ 1983-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k831209-gentamicin-calibrator-aca-fda-510k.jpg K831209 - GENTAMICIN CALIBRATOR -ACA K831209 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared May 1983. https://www.510kdatabase.net/k831242/ 1983-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k831242-lithium-heparinized-blood-collect-tube-fda-510k.jpg K831242 - LITHIUM HEPARINIZED BLOOD COLLECT-TUBE K831242 is a FDA 510(k) cleared hematology medical device. Manufacturer: American Dade. Cleared May 1983. https://www.510kdatabase.net/k830701/ 1983-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k830701-stratus-phenobarbital-fluorometric-enz-fda-510k.jpg K830701 - STRATUS PHENOBARBITAL FLUOROMETRIC ENZ K830701 is a FDA 510(k) cleared toxicology medical device. Manufacturer: American Dade. Cleared May 1983. https://www.510kdatabase.net/k830925/ 1983-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k830925-mf-380-electrosurgical-unit-fda-510k.jpg K830925 - MF 380 ELECTROSURGICAL UNIT K830925 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Zimmer, Inc.. Cleared May 1983. https://www.510kdatabase.net/k830978/ 1983-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k830978-helena-biostrip-a-fda-510k.jpg K830978 - HELENA BIOSTRIP A K830978 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared May 1983. https://www.510kdatabase.net/k830857/ 1983-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k830857-harris-ar-c-acetabular-cup-fda-510k.jpg K830857 - HARRIS A.R. C. ACETABULAR CUP K830857 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared May 1983. https://www.510kdatabase.net/k830955/ 1983-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k830955-dental-ceramic-for-fabrication-of-crown-fda-510k.jpg K830955 - DENTAL CERAMIC FOR FABRICATION OF CROWN K830955 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared May 1983. https://www.510kdatabase.net/k831030/ 1983-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k831030-cobas-standards-for-glucose-bun-fda-510k.jpg K831030 - COBAS STANDARDS FOR GLUCOSE & BUN K831030 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Roche Diagnostic Systems, Inc.. Cleared May 1983. https://www.510kdatabase.net/k831104/ 1983-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k831104-tenzcare-muscle-stimulation-electrodes-fda-510k.jpg K831104 - TENZCARE MUSCLE STIMULATION ELECTRODES K831104 is a FDA 510(k) cleared neurology medical device. Manufacturer: 3M Company. Cleared May 1983. https://www.510kdatabase.net/k831153/ 1983-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k831153-cefaxolin-30-mcg-sensi-disc-fda-510k.jpg K831153 - CEFAXOLIN 30 MCG SENSI-DISC K831153 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared May 1983. https://www.510kdatabase.net/k831214/ 1983-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k831214-delta-teeth-fda-510k.jpg K831214 - DELTA TEETH K831214 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared May 1983. https://www.510kdatabase.net/k831222/ 1983-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k831222-carbamezepine-reagent-test-kit-fda-510k.jpg K831222 - CARBAMEZEPINE REAGENT TEST KIT K831222 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared May 1983. https://www.510kdatabase.net/k831253/ 1983-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k831253-lancer-hemoglobin-analyzer-reagents-fda-510k.jpg K831253 - LANCER HEMOGLOBIN ANALYZER REAGENTS K831253 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sherwood Medical Co.. Cleared May 1983. https://www.510kdatabase.net/k821135/ 1983-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k821135-prealbumin-enzyme-immunoassay-fda-510k.jpg K821135 - PREALBUMIN ENZYME IMMUNOASSAY K821135 is a FDA 510(k) cleared hematology medical device. Manufacturer: Abbott Laboratories. Cleared May 1983. https://www.510kdatabase.net/k830979/ 1983-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k830979-helena-biostrip-ph-fda-510k.jpg K830979 - HELENA BIOSTRIP PH K830979 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared May 1983. https://www.510kdatabase.net/k830964/ 1983-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k830964-anaerobe-micid-template-taxonomy-fda-510k.jpg K830964 - ANAEROBE MIC/ID TEMPLATE, & TAXONOMY K830964 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared May 1983. https://www.510kdatabase.net/k830976/ 1983-05-04 monthly 0.5 https://www.510kdatabase.net/og-image/k830976-helena-biostrip-k-fda-510k.jpg K830976 - HELENA BIOSTRIP K K830976 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared May 1983. https://www.510kdatabase.net/k830510/ 1983-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k830510-bbl-strep-grouping-kit-fda-510k.jpg K830510 - BBL STREP GROUPING KIT K830510 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared May 1983. https://www.510kdatabase.net/k830977/ 1983-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k830977-helena-biostrip-p-fda-510k.jpg K830977 - HELENA BIOSTRIP P K830977 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Apr 1983. https://www.510kdatabase.net/k830451/ 1983-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k830451-qbc-centrifugal-hematology-sys-fda-510k.jpg K830451 - QBC CENTRIFUGAL HEMATOLOGY SYS K830451 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1983. https://www.510kdatabase.net/k830121/ 1983-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k830121-insallburstein-fiber-metal-condylarkne-fda-510k.jpg K830121 - INSALL/BURSTEIN FIBER METAL CONDYLAR/KNE K830121 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Apr 1983. https://www.510kdatabase.net/k831046/ 1983-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k831046-electrode-3799-fda-510k.jpg K831046 - ELECTRODE 3799 K831046 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Apr 1983. https://www.510kdatabase.net/k837334/ 1983-04-22 monthly 0.5 https://www.510kdatabase.net/og-image/k837334-x-ray-beam-filter-fda-510k.jpg K837334 - X-RAY BEAM FILTER K837334 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Apr 1983. https://www.510kdatabase.net/k837354/ 1983-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k837354-powered-mobile-base-for-200mm-and-fda-510k.jpg K837354 - POWERED MOBILE BASE FOR 200MM AND 300MM SIZE DETECTORS K837354 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Apr 1983. https://www.510kdatabase.net/k830004/ 1983-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k830004-porocoat-dual-lock-total-hip-system-fda-510k.jpg K830004 - POROCOAT DUAL-LOCK TOTAL HIP SYSTEM K830004 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Apr 1983. https://www.510kdatabase.net/k830782/ 1983-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k830782-lifeline-endocardial-pacing-lead-479-05-fda-510k.jpg K830782 - LIFELINE ENDOCARDIAL PACING LEAD #479-05 K830782 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Apr 1983. https://www.510kdatabase.net/k830452/ 1983-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k830452-pca-pump-fda-510k.jpg K830452 - PCA PUMP K830452 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1983. https://www.510kdatabase.net/k830486/ 1983-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k830486-infusion-pump-as6h-fda-510k.jpg K830486 - INFUSION PUMP #AS*6H K830486 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Apr 1983. https://www.510kdatabase.net/k830809/ 1983-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k830809-grase-by-dynamics-ms-27-syringe-driver-fda-510k.jpg K830809 - GRASE BY DYNAMICS MS 27 SYRINGE DRIVER K830809 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Intermedics, Inc.. Cleared Apr 1983. https://www.510kdatabase.net/k830199/ 1983-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k830199-auto-suture-ta-dispos-staple-cart-fda-510k.jpg K830199 - AUTO SUTURE TA DISPOS-STAPLE CART K830199 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Apr 1983. https://www.510kdatabase.net/k830762/ 1983-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k830762-olympus-high-speed-analyzer-fda-510k.jpg K830762 - OLYMPUS HIGH SPEED ANALYZER K830762 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Apr 1983. https://www.510kdatabase.net/k830789/ 1983-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k830789-ames-tda-valproic-acid-test-fda-510k.jpg K830789 - AMES TDA VALPROIC ACID TEST K830789 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Apr 1983. https://www.510kdatabase.net/k830834/ 1983-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k830834-negative-urine-control-fda-510k.jpg K830834 - NEGATIVE URINE CONTROL K830834 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Apr 1983. https://www.510kdatabase.net/k830872/ 1983-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k830872-titan-gel-ldh-iso-enzyme-control-fda-510k.jpg K830872 - TITAN GEL LDH ISO-ENZYME CONTROL K830872 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Apr 1983. https://www.510kdatabase.net/k830912/ 1983-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k830912-tdx-t-uptake-fda-510k.jpg K830912 - TDX T-UPTAKE K830912 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1983. https://www.510kdatabase.net/k837201/ 1983-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k837201-kodak-lanex-fast-screens-so-470-fda-510k.jpg K837201 - KODAK LANEX FAST SCREENS SO-470 K837201 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Apr 1983. https://www.510kdatabase.net/k837202/ 1983-04-11 monthly 0.5 https://www.510kdatabase.net/og-image/k837202-kodak-ortho-c-film-so-344-fda-510k.jpg K837202 - KODAK ORTHO C FILM SO-344 K837202 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Apr 1983. https://www.510kdatabase.net/k830694/ 1983-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k830694-dupont-prep-type-cs-extraction-cartride-fda-510k.jpg K830694 - DUPONT PREP TYPE CS EXTRACTION CARTRIDE K830694 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Apr 1983. https://www.510kdatabase.net/k830698/ 1983-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k830698-quantum-ii-bacterial-ident-system-fda-510k.jpg K830698 - QUANTUM II BACTERIAL IDENT. SYSTEM K830698 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1983. https://www.510kdatabase.net/k830732/ 1983-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k830732-netilmicin-30-mcg-sensi-disc-fda-510k.jpg K830732 - NETILMICIN 30 MCG SENSI DISC K830732 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1983. https://www.510kdatabase.net/k830553/ 1983-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k830553-dental-porcelain-powder-fda-510k.jpg K830553 - DENTAL PORCELAIN POWDER K830553 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Apr 1983. https://www.510kdatabase.net/k830683/ 1983-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k830683-tdx-thyroxine-fda-510k.jpg K830683 - TDX THYROXINE K830683 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1983. https://www.510kdatabase.net/k830320/ 1983-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k830320-activat-partial-thrombo-plastin-fda-510k.jpg K830320 - ACTIVAT-PARTIAL THROMBO-PLASTIN K830320 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Apr 1983. https://www.510kdatabase.net/k830331/ 1983-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k830331-liquid-thromboplastin-reagent-fda-510k.jpg K830331 - LIQUID THROMBOPLASTIN REAGENT K830331 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Apr 1983. https://www.510kdatabase.net/k830518/ 1983-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k830518-emit-st-photometer-diluter-verifica-fda-510k.jpg K830518 - EMIT-ST PHOTOMETER & DILUTER VERIFICA K830518 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Apr 1983. https://www.510kdatabase.net/k830692/ 1983-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k830692-dupont-prep-od-extraction-cartride-fda-510k.jpg K830692 - DUPONT PREP OD EXTRACTION CARTRIDE K830692 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Apr 1983. https://www.510kdatabase.net/k830693/ 1983-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k830693-dupont-prep-type-as-extraction-cartride-fda-510k.jpg K830693 - DUPONT PREP TYPE AS EXTRACTION CARTRIDE K830693 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Apr 1983. https://www.510kdatabase.net/k830315/ 1983-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k830315-dual-channel-recorder-78574a-fda-510k.jpg K830315 - DUAL CHANNEL RECORDER #78574A K830315 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Mar 1983. https://www.510kdatabase.net/k830765/ 1983-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k830765-winged-catheter-fda-510k.jpg K830765 - WINGED CATHETER K830765 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1983. https://www.510kdatabase.net/k823843/ 1983-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k823843-freeman-acetabular-cup-fda-510k.jpg K823843 - FREEMAN ACETABULAR CUP K823843 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Depuy, Inc.. Cleared Mar 1983. https://www.510kdatabase.net/k830386/ 1983-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k830386-davol-surgical-suction-irrigation-instr-fda-510k.jpg K830386 - DAVOL SURGICAL SUCTION IRRIGATION INSTR K830386 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 1983. https://www.510kdatabase.net/k830545/ 1983-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k830545-dispersive-electrode-fda-510k.jpg K830545 - DISPERSIVE ELECTRODE K830545 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 1983. https://www.510kdatabase.net/k830671/ 1983-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k830671-thorax-klex-chest-drainage-unit-fda-510k.jpg K830671 - THORAX-KLEX CHEST DRAINAGE UNIT K830671 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 1983. https://www.510kdatabase.net/k830695/ 1983-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k830695-beta-cote-b-hcg-pregnancy-screening-sys-fda-510k.jpg K830695 - BETA-COTE B-HCG PREGNANCY SCREENING SYS K830695 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1983. https://www.510kdatabase.net/k830709/ 1983-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k830709-argyle-suction-catheters-fda-510k.jpg K830709 - ARGYLE SUCTION CATHETERS K830709 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sherwood Medical Co.. Cleared Mar 1983. https://www.510kdatabase.net/k830710/ 1983-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k830710-argyle-silicone-salem-sump-tube-fda-510k.jpg K830710 - ARGYLE SILICONE SALEM SUMP TUBE K830710 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Sherwood Medical Co.. Cleared Mar 1983. https://www.510kdatabase.net/k830729/ 1983-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k830729-c-dak-artificial-kidney-fda-510k.jpg K830729 - C-DAK ARTIFICIAL KIDNEY K830729 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Mar 1983. https://www.510kdatabase.net/k830766/ 1983-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k830766-abbott-patient-assist-device-fda-510k.jpg K830766 - ABBOTT PATIENT ASSIST DEVICE K830766 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1983. https://www.510kdatabase.net/k830322/ 1983-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k830322-cat-reagent-kit-fda-510k.jpg K830322 - C.A.T. REAGENT KIT K830322 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Mar 1983. https://www.510kdatabase.net/k830196/ 1983-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k830196-corstren-compression-tube-plate-fda-510k.jpg K830196 - CORSTREN COMPRESSION TUBE & PLATE K830196 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Mar 1983. https://www.510kdatabase.net/k830363/ 1983-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k830363-bactec-170-tryptic-soy-broth-wresins-fda-510k.jpg K830363 - BACTEC 170 TRYPTIC SOY BROTH W/RESINS K830363 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1983. https://www.510kdatabase.net/k830594/ 1983-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k830594-titan-immuno-fix-fda-510k.jpg K830594 - TITAN IMMUNO-FIX K830594 is a FDA 510(k) cleared immunology medical device. Manufacturer: Helena Laboratories. Cleared Mar 1983. https://www.510kdatabase.net/k830608/ 1983-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k830608-usci-gruntzig-dilaca-balloon-dilation-fda-510k.jpg K830608 - USCI GRUNTZIG DILACA BALLOON DILATION K830608 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 1983. https://www.510kdatabase.net/k823059/ 1983-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k823059-dosimetry-release-of-radiation-steril-fda-510k.jpg K823059 - DOSIMETRY RELEASE OF RADIATION STERIL. K823059 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Mar 1983. https://www.510kdatabase.net/k823828/ 1983-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k823828-theracard-400-fda-510k.jpg K823828 - THERACARD 400 K823828 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 1983. https://www.510kdatabase.net/k830380/ 1983-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k830380-microdapt-dental-restorative-fda-510k.jpg K830380 - MICRODAPT DENTAL RESTORATIVE K830380 is a FDA 510(k) cleared dental medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Mar 1983. https://www.510kdatabase.net/k830387/ 1983-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k830387-microdapt-dental-restorative-bonding-fda-510k.jpg K830387 - MICRODAPT DENTAL RESTORATIVE BONDING K830387 is a FDA 510(k) cleared dental medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Mar 1983. https://www.510kdatabase.net/k830442/ 1983-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k830442-prisma-fine-fda-510k.jpg K830442 - PRISMA-FINE K830442 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Mar 1983. https://www.510kdatabase.net/k830491/ 1983-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k830491-johnson-johnson-opaque-color-modifi-fda-510k.jpg K830491 - JOHNSON & JOHNSON OPAQUE COLOR MODIFI K830491 is a FDA 510(k) cleared dental medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Mar 1983. https://www.510kdatabase.net/k830645/ 1983-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k830645-bleeding-time-device-disposable-fda-510k.jpg K830645 - BLEEDING TIME DEVICE DISPOSABLE K830645 is a FDA 510(k) cleared hematology medical device. Manufacturer: American Dade. Cleared Mar 1983. https://www.510kdatabase.net/k823831/ 1983-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k823831-medtronic-models-59401-5941-fda-510k.jpg K823831 - MEDTRONIC MODELS 59401 5941 K823831 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Mar 1983. https://www.510kdatabase.net/k823357/ 1983-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k823357-various-cardiovascular-products-fda-510k.jpg K823357 - VARIOUS CARDIOVASCULAR PRODUCTS K823357 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 1983. https://www.510kdatabase.net/k823829/ 1983-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k823829-ferritin-immunoradiometric-assay-kit-fda-510k.jpg K823829 - FERRITIN IMMUNORADIOMETRIC ASSAY KIT K823829 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1983. https://www.510kdatabase.net/k830002/ 1983-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k830002-capd-color-guard-system-prepkit-fda-510k.jpg K830002 - CAPD COLOR-GUARD SYSTEM PREPKIT K830002 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1983. https://www.510kdatabase.net/k822721/ 1983-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k822721-no-boil-solid-phase-simul-trac-b12-fda-510k.jpg K822721 - NO-BOIL SOLID PHASE SIMUL TRAC B12 K822721 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1983. https://www.510kdatabase.net/k823345/ 1983-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k823345-patch-fda-510k.jpg K823345 - PATCH K823345 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Mar 1983. https://www.510kdatabase.net/k823863/ 1983-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k823863-cyberlith-ix-quantum-unipolar-cardiac-fda-510k.jpg K823863 - CYBERLITH IX QUANTUM-UNIPOLAR CARDIAC K823863 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Mar 1983. https://www.510kdatabase.net/k830307/ 1983-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k830307-aufranc-turner-ats-total-hip-system-fda-510k.jpg K830307 - AUFRANC-TURNER ATS TOTAL HIP SYSTEM K830307 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Mar 1983. https://www.510kdatabase.net/k830398/ 1983-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k830398-tdx-methotrexate-fda-510k.jpg K830398 - TDX METHOTREXATE K830398 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1983. https://www.510kdatabase.net/k830287/ 1983-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k830287-zimmer-skin-protector-fda-510k.jpg K830287 - ZIMMER SKIN PROTECTOR K830287 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Zimmer, Inc.. Cleared Mar 1983. https://www.510kdatabase.net/k830356/ 1983-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k830356-titanium-me-muller-type-total-hip-fda-510k.jpg K830356 - TITANIUM M.E. MULLER TYPE TOTAL HIP K830356 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Mar 1983. https://www.510kdatabase.net/k837107/ 1983-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k837107-somatom-dri-x-ray-ct-scanner-fda-510k.jpg K837107 - SOMATOM DRI X-RAY CT SCANNER K837107 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Mar 1983. https://www.510kdatabase.net/k830396/ 1983-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k830396-urea-pda-disk-fda-510k.jpg K830396 - UREA-PDA DISK K830396 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Mar 1983. https://www.510kdatabase.net/k830503/ 1983-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k830503-ligaclip-titanium-ligating-clip-fda-510k.jpg K830503 - LIGACLIP TITANIUM LIGATING CLIP K830503 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Mar 1983. https://www.510kdatabase.net/k823135/ 1983-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k823135-double-lumen-subclavian-catheter-fda-510k.jpg K823135 - DOUBLE LUMEN SUBCLAVIAN CATHETER K823135 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1983. https://www.510kdatabase.net/k823884/ 1983-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k823884-paragon-immunoelectrophoresis-reagent-fda-510k.jpg K823884 - PARAGON IMMUNOELECTROPHORESIS REAGENT K823884 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Mar 1983. https://www.510kdatabase.net/k830208/ 1983-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k830208-beta-cap-d-adapter-fda-510k.jpg K830208 - BETA-CAP D ADAPTER K830208 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quinton, Inc.. Cleared Mar 1983. https://www.510kdatabase.net/k830318/ 1983-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k830318-paramax-analytical-sys-fda-510k.jpg K830318 - PARAMAX ANALYTICAL SYS K830318 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Mar 1983. https://www.510kdatabase.net/k830423/ 1983-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k830423-syringe-driver-ms-16-fda-510k.jpg K830423 - SYRINGE DRIVER MS-16 K830423 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Intermedics, Inc.. Cleared Mar 1983. https://www.510kdatabase.net/k823569/ 1983-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k823569-abbott-laboratories-strep-a-eia-fda-510k.jpg K823569 - ABBOTT LABORATORIES STREP A EIA K823569 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1983. https://www.510kdatabase.net/k830360/ 1983-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k830360-3m-osteotomy-guide-fda-510k.jpg K830360 - 3M OSTEOTOMY GUIDE K830360 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 3M Company. Cleared Mar 1983. https://www.510kdatabase.net/k830102/ 1983-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k830102-harvard-apparatus-intermittent-infusion-fda-510k.jpg K830102 - HARVARD APPARATUS INTERMITTENT INFUSION K830102 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Feb 1983. https://www.510kdatabase.net/k830149/ 1983-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k830149-il-video-2221-ii-atomic-spectrophoto--fda-510k.jpg K830149 - IL VIDEO 22,21 & II ATOMIC SPECTROPHOTO- K830149 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Feb 1983. https://www.510kdatabase.net/k830323/ 1983-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k830323-lysostaphin-reagent-set-fda-510k.jpg K830323 - LYSOSTAPHIN REAGENT SET K830323 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Feb 1983. https://www.510kdatabase.net/k830463/ 1983-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k830463-lifeline-unipolar-j-lead-483-05-fda-510k.jpg K830463 - LIFELINE UNIPOLAR J-LEAD #483-05 K830463 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Feb 1983. https://www.510kdatabase.net/k830408/ 1983-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k830408-freemansamuelson-total-knee-fda-510k.jpg K830408 - FREEMAN/SAMUELSON TOTAL KNEE K830408 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Feb 1983. https://www.510kdatabase.net/k830094/ 1983-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k830094-usci-temp-atrio-ventricular-electrode-fda-510k.jpg K830094 - USCI TEMP. ATRIO-VENTRICULAR ELECTRODE K830094 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Feb 1983. https://www.510kdatabase.net/k830151/ 1983-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k830151-external-infusion-pump-fda-510k.jpg K830151 - EXTERNAL INFUSION PUMP K830151 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Intermedics, Inc.. Cleared Feb 1983. https://www.510kdatabase.net/k830195/ 1983-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k830195-no-boil-dual-count-vit-b12-folic-acid-fda-510k.jpg K830195 - NO BOIL DUAL COUNT VIT-B12 & FOLIC ACID K830195 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Feb 1983. https://www.510kdatabase.net/k830206/ 1983-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k830206-tdx-n-acetylprocainamide-fda-510k.jpg K830206 - TDX N-ACETYLPROCAINAMIDE K830206 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Feb 1983. https://www.510kdatabase.net/k823748/ 1983-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k823748-expanded-ptfe-prosthesis-blood-acces-fda-510k.jpg K823748 - EXPANDED PTFE PROSTHESIS BLOOD ACCES K823748 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Feb 1983. https://www.510kdatabase.net/k830099/ 1983-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k830099-ms-2-bacterial-identi-sys-fda-510k.jpg K830099 - MS-2 BACTERIAL IDENTI. SYS K830099 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Feb 1983. https://www.510kdatabase.net/k830065/ 1983-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k830065-salmonella-shigella-agar-fda-510k.jpg K830065 - SALMONELLA-SHIGELLA AGAR K830065 is a FDA 510(k) cleared immunology medical device. Manufacturer: bioMerieux, Inc.. Cleared Feb 1983. https://www.510kdatabase.net/k830080/ 1983-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k830080-bile-esculin-azide-agar-fda-510k.jpg K830080 - BILE ESCULIN AZIDE AGAR K830080 is a FDA 510(k) cleared immunology medical device. Manufacturer: bioMerieux, Inc.. Cleared Feb 1983. https://www.510kdatabase.net/k830082/ 1983-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k830082-biggy-agar-fda-510k.jpg K830082 - BIGGY AGAR K830082 is a FDA 510(k) cleared immunology medical device. Manufacturer: bioMerieux, Inc.. Cleared Feb 1983. https://www.510kdatabase.net/k813265/ 1983-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k813265-3m-steri-strip-antimicrobial-skin-clos-fda-510k.jpg K813265 - 3M STERI-STRIP ANTIMICROBIAL SKIN CLOS K813265 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3M Company. Cleared Feb 1983. https://www.510kdatabase.net/k830059/ 1983-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k830059-mueller-hinton-w50-sheep-blood-fda-510k.jpg K830059 - MUELLER HINTON W/50% SHEEP BLOOD K830059 is a FDA 510(k) cleared immunology medical device. Manufacturer: bioMerieux, Inc.. Cleared Feb 1983. https://www.510kdatabase.net/k830060/ 1983-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k830060-mueller-hinton-fda-510k.jpg K830060 - MUELLER HINTON K830060 is a FDA 510(k) cleared immunology medical device. Manufacturer: bioMerieux, Inc.. Cleared Feb 1983. https://www.510kdatabase.net/k830061/ 1983-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k830061-thayer-martin-modified-fda-510k.jpg K830061 - THAYER-MARTIN, MODIFIED K830061 is a FDA 510(k) cleared immunology medical device. Manufacturer: bioMerieux, Inc.. Cleared Feb 1983. https://www.510kdatabase.net/k830062/ 1983-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k830062-martin-lewis-agar-fda-510k.jpg K830062 - MARTIN-LEWIS AGAR K830062 is a FDA 510(k) cleared immunology medical device. Manufacturer: bioMerieux, Inc.. Cleared Feb 1983. https://www.510kdatabase.net/k830063/ 1983-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k830063-contact-plate-lecithin-polysorbate-80-fda-510k.jpg K830063 - CONTACT PLATE LECITHIN & POLYSORBATE 80 K830063 is a FDA 510(k) cleared immunology medical device. Manufacturer: bioMerieux, Inc.. Cleared Feb 1983. https://www.510kdatabase.net/k830064/ 1983-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k830064-xld-agar-fda-510k.jpg K830064 - XLD AGAR K830064 is a FDA 510(k) cleared immunology medical device. Manufacturer: bioMerieux, Inc.. Cleared Feb 1983. https://www.510kdatabase.net/k830066/ 1983-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k830066-sabourand-dextrose-agar-fda-510k.jpg K830066 - SABOURAND DEXTROSE AGAR K830066 is a FDA 510(k) cleared immunology medical device. Manufacturer: bioMerieux, Inc.. Cleared Feb 1983. https://www.510kdatabase.net/k830067/ 1983-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k830067-phenylethanol-agar-w50-sheep-blood-fda-510k.jpg K830067 - PHENYLETHANOL AGAR W/50% SHEEP BLOOD K830067 is a FDA 510(k) cleared immunology medical device. Manufacturer: bioMerieux, Inc.. Cleared Feb 1983. https://www.510kdatabase.net/k830068/ 1983-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k830068-nutrient-agar-fda-510k.jpg K830068 - NUTRIENT AGAR K830068 is a FDA 510(k) cleared immunology medical device. Manufacturer: bioMerieux, Inc.. Cleared Feb 1983. https://www.510kdatabase.net/k830069/ 1983-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k830069-mycobiotic-agar-fda-510k.jpg K830069 - MYCOBIOTIC AGAR K830069 is a FDA 510(k) cleared immunology medical device. Manufacturer: bioMerieux, Inc.. Cleared Feb 1983. https://www.510kdatabase.net/k830070/ 1983-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k830070-mannitol-salt-agar-fda-510k.jpg K830070 - MANNITOL SALT AGAR K830070 is a FDA 510(k) cleared immunology medical device. Manufacturer: bioMerieux, Inc.. Cleared Feb 1983. https://www.510kdatabase.net/k830071/ 1983-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k830071-macconkey-agar-fda-510k.jpg K830071 - MACCONKEY AGAR K830071 is a FDA 510(k) cleared immunology medical device. Manufacturer: bioMerieux, Inc.. Cleared Feb 1983. https://www.510kdatabase.net/k830072/ 1983-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k830072-hektoen-enteric-agar-fda-510k.jpg K830072 - HEKTOEN ENTERIC AGAR K830072 is a FDA 510(k) cleared immunology medical device. Manufacturer: bioMerieux, Inc.. Cleared Feb 1983. https://www.510kdatabase.net/k830073/ 1983-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k830073-levine-emb-agar-fda-510k.jpg K830073 - LEVINE EMB AGAR K830073 is a FDA 510(k) cleared immunology medical device. Manufacturer: bioMerieux, Inc.. Cleared Feb 1983. https://www.510kdatabase.net/k830074/ 1983-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k830074-chocolate-agar-enriched-fda-510k.jpg K830074 - CHOCOLATE AGAR, ENRICHED K830074 is a FDA 510(k) cleared immunology medical device. Manufacturer: bioMerieux, Inc.. Cleared Feb 1983. https://www.510kdatabase.net/k830075/ 1983-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k830075-columbia-sheep-blood-agar-5-fda-510k.jpg K830075 - COLUMBIA SHEEP BLOOD AGAR 5% K830075 is a FDA 510(k) cleared immunology medical device. Manufacturer: bioMerieux, Inc.. Cleared Feb 1983. https://www.510kdatabase.net/k830076/ 1983-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k830076-campylocacter-selective-agar-blasers-fda-510k.jpg K830076 - CAMPYLOCACTER SELECTIVE AGAR BLASER'S K830076 is a FDA 510(k) cleared immunology medical device. Manufacturer: bioMerieux, Inc.. Cleared Feb 1983. https://www.510kdatabase.net/k830077/ 1983-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k830077-brain-heart-infusion-agar-fda-510k.jpg K830077 - BRAIN HEART INFUSION AGAR K830077 is a FDA 510(k) cleared immunology medical device. Manufacturer: bioMerieux, Inc.. Cleared Feb 1983. https://www.510kdatabase.net/k830078/ 1983-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k830078-blood-agartsa-w5-sheep-blood-fda-510k.jpg K830078 - BLOOD AGAR(TSA W/5% SHEEP BLOOD) K830078 is a FDA 510(k) cleared immunology medical device. Manufacturer: bioMerieux, Inc.. Cleared Feb 1983. https://www.510kdatabase.net/k830079/ 1983-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k830079-bismuth-sulfite-agar-fda-510k.jpg K830079 - BISMUTH SULFITE AGAR K830079 is a FDA 510(k) cleared immunology medical device. Manufacturer: bioMerieux, Inc.. Cleared Feb 1983. https://www.510kdatabase.net/k830081/ 1983-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k830081-bile-esculin-agar-fda-510k.jpg K830081 - BILE ESCULIN AGAR K830081 is a FDA 510(k) cleared immunology medical device. Manufacturer: bioMerieux, Inc.. Cleared Feb 1983. https://www.510kdatabase.net/k830124/ 1983-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k830124-option-a02-model-15202a-fda-510k.jpg K830124 - OPTION A02 MODEL 15202A K830124 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Feb 1983. https://www.510kdatabase.net/k823352/ 1983-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k823352-immu-trace-tri-rac-r-tri-level-controls-fda-510k.jpg K823352 - IMMU-TRACE TRI-RAC R TRI-LEVEL CONTROLS K823352 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Feb 1983. https://www.510kdatabase.net/k823420/ 1983-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k823420-kinematic-ii-knee-system-fda-510k.jpg K823420 - KINEMATIC II KNEE SYSTEM K823420 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Feb 1983. https://www.510kdatabase.net/k823718/ 1983-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k823718-sceptor-gram-positive-panel-mic10-temp-fda-510k.jpg K823718 - SCEPTOR GRAM-POSITIVE PANEL, MIC/10 TEMP K823718 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Feb 1983. https://www.510kdatabase.net/k830122/ 1983-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k830122-continuous-anatomical-passive-exerciser-fda-510k.jpg K830122 - CONTINUOUS ANATOMICAL PASSIVE EXERCISER K830122 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zimmer, Inc.. Cleared Feb 1983. https://www.510kdatabase.net/k830136/ 1983-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k830136-paramount-thyroxine-assay-fda-510k.jpg K830136 - PARAMOUNT THYROXINE ASSAY K830136 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Feb 1983. https://www.510kdatabase.net/k830177/ 1983-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k830177-harvard-apparatus-family-of-fluid-infus-fda-510k.jpg K830177 - HARVARD APPARATUS FAMILY OF FLUID INFUS K830177 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Feb 1983. https://www.510kdatabase.net/k830198/ 1983-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k830198-pediatric-exten-set-for-second-drug-fda-510k.jpg K830198 - PEDIATRIC EXTEN. SET FOR SECOND-DRUG K830198 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Feb 1983. https://www.510kdatabase.net/k823598/ 1983-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k823598-large-terrycloth-bib-fda-510k.jpg K823598 - LARGE TERRYCLOTH BIB K823598 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Feb 1983. https://www.510kdatabase.net/k823631/ 1983-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k823631-non-slip-vinyl-bath-mat-fda-510k.jpg K823631 - NON-SLIP VINYL BATH MAT K823631 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Feb 1983. https://www.510kdatabase.net/k823643/ 1983-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k823643-inflatable-pillow-fda-510k.jpg K823643 - INFLATABLE PILLOW K823643 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Feb 1983. https://www.510kdatabase.net/k823651/ 1983-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k823651-scissors-fda-510k.jpg K823651 - SCISSORS K823651 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Feb 1983. https://www.510kdatabase.net/k823652/ 1983-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k823652-primary-solution-salvent-based-coat-met-fda-510k.jpg K823652 - PRIMARY SOLUTION SALVENT BASED COAT- MET K823652 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Feb 1983. https://www.510kdatabase.net/k823653/ 1983-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k823653-thinning-solution-salvent-based-coat-mat-fda-510k.jpg K823653 - THINNING SOLUTION SALVENT BASED COAT-MAT K823653 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Feb 1983. https://www.510kdatabase.net/k823655/ 1983-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k823655-book-on-mgmt-of-the-burn-patient-fda-510k.jpg K823655 - BOOK ON MGMT. OF THE BURN PATIENT K823655 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Feb 1983. https://www.510kdatabase.net/k830146/ 1983-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k830146-program-treadmill-controller-645-fda-510k.jpg K830146 - PROGRAM. TREADMILL CONTROLLER #645 K830146 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Quinton, Inc.. Cleared Feb 1983. https://www.510kdatabase.net/k823869/ 1983-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k823869-glyco-hb-quik-column-procedure-fda-510k.jpg K823869 - GLYCO HB QUIK COLUMN PROCEDURE K823869 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Feb 1983. https://www.510kdatabase.net/k823870/ 1983-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k823870-beta-thalquik-column-5341-fda-510k.jpg K823870 - BETA THALQUIK COLUMN #5341 K823870 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Feb 1983. https://www.510kdatabase.net/k823887/ 1983-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k823887-advance-emit-cad-disopyramide-assay-fda-510k.jpg K823887 - ADVANCE EMIT CAD DISOPYRAMIDE ASSAY K823887 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jan 1983. https://www.510kdatabase.net/k830035/ 1983-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k830035-sopheia-digitoxin-eia-kit-components-fda-510k.jpg K830035 - SOPHEIA DIGITOXIN EIA KIT & COMPONENTS K830035 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jan 1983. https://www.510kdatabase.net/k830049/ 1983-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k830049-advance-emit-cad-disopyramide-control-fda-510k.jpg K830049 - ADVANCE EMIT-CAD DISOPYRAMIDE CONTROL K830049 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Jan 1983. https://www.510kdatabase.net/k830093/ 1983-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k830093-usci-electronic-manometer-fda-510k.jpg K830093 - USCI ELECTRONIC MANOMETER K830093 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 1983. https://www.510kdatabase.net/k830097/ 1983-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k830097-aufranc-turner-ats-metal-backed-acetabu-fda-510k.jpg K830097 - AUFRANC-TURNER ATS METAL BACKED ACETABU K830097 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Howmedica Corp.. Cleared Jan 1983. https://www.510kdatabase.net/k823268/ 1983-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k823268-model-78670a-fda-510k.jpg K823268 - MODEL 78670A K823268 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Jan 1983. https://www.510kdatabase.net/k823928/ 1983-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k823928-tooth-conditioner-fda-510k.jpg K823928 - TOOTH CONDITIONER K823928 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jan 1983. https://www.510kdatabase.net/k830017/ 1983-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k830017-volumetric-pump-admin-sets-fda-510k.jpg K830017 - VOLUMETRIC PUMP ADMIN. SETS K830017 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Jan 1983. https://www.510kdatabase.net/k830057/ 1983-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k830057-20-micron-high-capacity-transfilter-fda-510k.jpg K830057 - 20 MICRON HIGH CAPACITY TRANS/FILTER K830057 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Jan 1983. https://www.510kdatabase.net/k823342/ 1983-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k823342-percor-intra-aortic-balloon-insertion-fda-510k.jpg K823342 - PERCOR INTRA-AORTIC BALLOON INSERTION K823342 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Jan 1983. https://www.510kdatabase.net/k823405/ 1983-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k823405-zimmer-great-toe-fda-510k.jpg K823405 - ZIMMER GREAT TOE K823405 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jan 1983. https://www.510kdatabase.net/k823495/ 1983-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k823495-mobilimb-cpm-upperlower-limb-device-fda-510k.jpg K823495 - MOBILIMB-CPM UPPER/LOWER LIMB DEVICE K823495 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Synthes (Usa). Cleared Jan 1983. https://www.510kdatabase.net/k823637/ 1983-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k823637-arm-through-for-wheelchair-bk-6458-01-fda-510k.jpg K823637 - ARM THROUGH FOR WHEELCHAIR BK-6458-01 K823637 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jan 1983. https://www.510kdatabase.net/k823638/ 1983-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k823638-arm-through-for-wheelchair-bk-6454-01-fda-510k.jpg K823638 - ARM THROUGH FOR WHEELCHAIR BK 6454-01 & K823638 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jan 1983. https://www.510kdatabase.net/k823639/ 1983-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k823639-board-to-transfer-paralyzed-patient-from-fda-510k.jpg K823639 - BOARD TO TRANSFER PARALYZED PATIENT FROM K823639 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jan 1983. https://www.510kdatabase.net/k823640/ 1983-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k823640-bath-tub-safety-bar-fda-510k.jpg K823640 - BATH TUB SAFETY BAR K823640 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jan 1983. https://www.510kdatabase.net/k823641/ 1983-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k823641-bathing-chair-for-child-fda-510k.jpg K823641 - BATHING CHAIR FOR CHILD K823641 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jan 1983. https://www.510kdatabase.net/k823644/ 1983-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k823644-finger-flexion-splint-fda-510k.jpg K823644 - FINGER FLEXION SPLINT K823644 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jan 1983. https://www.510kdatabase.net/k823645/ 1983-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k823645-velcro-straps-to-hold-arm-to-wheelchair-fda-510k.jpg K823645 - VELCRO STRAPS TO HOLD ARM TO WHEELCHAIR K823645 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jan 1983. https://www.510kdatabase.net/k823646/ 1983-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k823646-friction-feeder-fda-510k.jpg K823646 - FRICTION FEEDER K823646 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jan 1983. https://www.510kdatabase.net/k823647/ 1983-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k823647-finger-extension-splint-fda-510k.jpg K823647 - FINGER EXTENSION SPLINT K823647 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jan 1983. https://www.510kdatabase.net/k823648/ 1983-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k823648-surgical-tubing-fda-510k.jpg K823648 - SURGICAL TUBING K823648 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jan 1983. https://www.510kdatabase.net/k823649/ 1983-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k823649-thermoelastomer-hotcold-compress-bk7186-fda-510k.jpg K823649 - THERMOELASTOMER HOT/COLD COMPRESS BK7186 K823649 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jan 1983. https://www.510kdatabase.net/k823650/ 1983-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k823650-thermoelastomer-hotcold-compress-7187--fda-510k.jpg K823650 - THERMOELASTOMER HOT/COLD COMPRESS-7187- K823650 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jan 1983. https://www.510kdatabase.net/k823654/ 1983-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k823654-slip-on-sandals-for-measuring-shortness-fda-510k.jpg K823654 - SLIP-ON SANDALS FOR MEASURING SHORTNESS K823654 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jan 1983. https://www.510kdatabase.net/k823656/ 1983-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k823656-soft-catchers-mitt-fda-510k.jpg K823656 - SOFT CATCHER'S MITT K823656 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jan 1983. https://www.510kdatabase.net/k823657/ 1983-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k823657-card-holder-for-quads-fda-510k.jpg K823657 - CARD HOLDER FOR QUADS K823657 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jan 1983. https://www.510kdatabase.net/k823742/ 1983-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k823742-neuromod-complement-7724-dual-channel-fda-510k.jpg K823742 - NEUROMOD COMPLEMENT #7724 DUAL CHANNEL K823742 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Jan 1983. https://www.510kdatabase.net/k823761/ 1983-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k823761-erythrocyte-stand-sediment-rate-tube-fda-510k.jpg K823761 - ERYTHROCYTE & STAND SEDIMENT. RATE TUBE K823761 is a FDA 510(k) cleared hematology medical device. Manufacturer: Cordis Corp.. Cleared Jan 1983. https://www.510kdatabase.net/k823836/ 1983-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k823836-monoject-samplette-capillary-blood-coll-fda-510k.jpg K823836 - MONOJECT SAMPLETTE CAPILLARY BLOOD COLL K823836 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sherwood Medical Co.. Cleared Jan 1983. https://www.510kdatabase.net/k823473/ 1983-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k823473-porocoat-mark-iv-elbow-fda-510k.jpg K823473 - POROCOAT MARK IV ELBOW K823473 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jan 1983. https://www.510kdatabase.net/k823763/ 1983-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k823763-various-specimen-collectors-fda-510k.jpg K823763 - VARIOUS-SPECIMEN COLLECTORS K823763 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cordis Corp.. Cleared Jan 1983. https://www.510kdatabase.net/k823419/ 1983-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k823419-hc-1m-metalbacked-acetabular-cup-fda-510k.jpg K823419 - HC 1M METALBACKED ACETABULAR CUP K823419 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Jan 1983. https://www.510kdatabase.net/k823901/ 1983-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k823901-trephine-blades-various-models-fda-510k.jpg K823901 - TREPHINE BLADES-VARIOUS MODELS K823901 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Edward Weck, Inc.. Cleared Jan 1983. https://www.510kdatabase.net/k830014/ 1983-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k830014-hema-nv-trans-blood-filter-100800-fda-510k.jpg K830014 - HEMA - NV TRANS. BLOOD FILTER 100/800 K830014 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Jan 1983. https://www.510kdatabase.net/k823508/ 1983-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k823508-lifeline-unipolar-lead-487-05-fda-510k.jpg K823508 - LIFELINE -UNIPOLAR LEAD #487-05 K823508 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Jan 1983. https://www.510kdatabase.net/k823562/ 1983-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k823562-emg-modules-for-polygraph-system-fda-510k.jpg K823562 - EMG MODULES FOR POLYGRAPH SYSTEM K823562 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Jan 1983. https://www.510kdatabase.net/k823716/ 1983-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k823716-cystoflo-urinary-drainage-bag-wantimic-fda-510k.jpg K823716 - CYSTOFLO URINARY DRAINAGE BAG W/ANTIMIC K823716 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Jan 1983. https://www.510kdatabase.net/k823760/ 1983-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k823760-prick-test-needle-fda-510k.jpg K823760 - PRICK-TEST NEEDLE K823760 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cordis Corp.. Cleared Jan 1983. https://www.510kdatabase.net/k823801/ 1983-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k823801-ames-tda-ethosuximide-test-fda-510k.jpg K823801 - AMES TDA ETHOSUXIMIDE TEST K823801 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Jan 1983. https://www.510kdatabase.net/k823865/ 1983-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k823865-advance-sys-emit-cad-lidocaine-control-fda-510k.jpg K823865 - ADVANCE SYS. EMIT-CAD LIDOCAINE CONTROL K823865 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Jan 1983. https://www.510kdatabase.net/k830021/ 1983-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k830021-av-fistula-cannulation-sets-fda-510k.jpg K830021 - A.V. FISTULA CANNULATION SETS K830021 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Jan 1983. https://www.510kdatabase.net/k821717/ 1983-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k821717-gore-tes-expanded-ptfe-patch-fda-510k.jpg K821717 - GORE-TES EXPANDED PTFE PATCH K821717 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Jan 1983. https://www.510kdatabase.net/k823264/ 1983-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k823264-thyroxine-analysis-productsradio-free-fda-510k.jpg K823264 - THYROXINE ANALYSIS PRODUCTS/RADIO-FREE K823264 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jan 1983. https://www.510kdatabase.net/k823563/ 1983-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k823563-eeg-respiration-modules-polygraph-fda-510k.jpg K823563 - EEG & RESPIRATION MODULES POLYGRAPH K823563 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Jan 1983. https://www.510kdatabase.net/k823689/ 1983-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k823689-3m-scotchplate-51148-small-conductive-fda-510k.jpg K823689 - 3M SCOTCHPLATE 51148 SMALL CONDUCTIVE K823689 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3M Company. Cleared Jan 1983. https://www.510kdatabase.net/k823746/ 1983-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k823746-advance-sys-emit-aed-antiepileptic-drug-fda-510k.jpg K823746 - ADVANCE SYS. EMIT-AED ANTIEPILEPTIC DRUG K823746 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Jan 1983. https://www.510kdatabase.net/k823751/ 1983-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k823751-sopheia-thyroxine-eia-kit-fda-510k.jpg K823751 - SOPHEIA THYROXINE EIA KIT K823751 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jan 1983. https://www.510kdatabase.net/k823762/ 1983-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k823762-various-analyzer-cups-fda-510k.jpg K823762 - VARIOUS-ANALYZER CUPS K823762 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Cordis Corp.. Cleared Jan 1983. https://www.510kdatabase.net/k823826/ 1983-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k823826-capillary-flow-dialyzers-fda-510k.jpg K823826 - CAPILLARY FLOW DIALYZERS K823826 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Jan 1983. https://www.510kdatabase.net/k823866/ 1983-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k823866-advance-emit-cad-lidocaine-assay-fda-510k.jpg K823866 - ADVANCE EMIT CAD LIDOCAINE ASSAY K823866 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Jan 1983. https://www.510kdatabase.net/k823480/ 1983-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k823480-il-943-flame-photometer-fda-510k.jpg K823480 - IL 943 FLAME PHOTOMETER K823480 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jan 1983. https://www.510kdatabase.net/k823851/ 1983-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k823851-orthodaptic-bonding-adhesive-fda-510k.jpg K823851 - ORTHODAPTIC* BONDING ADHESIVE K823851 is a FDA 510(k) cleared dental medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jan 1983. https://www.510kdatabase.net/k823888/ 1983-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k823888-3m-frascia-stapling-system-fda-510k.jpg K823888 - 3M FRASCIA STAPLING SYSTEM K823888 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3M Company. Cleared Jan 1983. https://www.510kdatabase.net/k823768/ 1983-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k823768-clirans-te08-hollow-fiber-dialyzer-fda-510k.jpg K823768 - CLIRANS TE08 HOLLOW FIBER DIALYZER K823768 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Terumo Medical Corp.. Cleared Jan 1983. https://www.510kdatabase.net/k822641/ 1983-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k822641-gore-tex-barrier-surg-drapes-gowns-fda-510k.jpg K822641 - GORE-TEX BARRIER SURG. DRAPES & GOWNS K822641 is a FDA 510(k) cleared general hospital medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Jan 1983. https://www.510kdatabase.net/k823561/ 1983-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k823561-urethral-pressure-profile-temp-modul-fda-510k.jpg K823561 - URETHRAL PRESSURE PROFILE & TEMP. MODUL K823561 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Jan 1983. https://www.510kdatabase.net/k823741/ 1983-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k823741-advance-emit-aed-primedone-assay-fda-510k.jpg K823741 - ADVANCE EMIT-AED PRIMEDONE ASSAY K823741 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Jan 1983. https://www.510kdatabase.net/k823745/ 1983-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k823745-advance-emit-aed-ethosuximide-fda-510k.jpg K823745 - ADVANCE EMIT-AED ETHOSUXIMIDE K823745 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Jan 1983. https://www.510kdatabase.net/k823777/ 1983-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k823777-sterile-dispos-spike-protector-5c4138-fda-510k.jpg K823777 - STERILE, DISPOS. SPIKE PROTECTOR-5C4138 K823777 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Jan 1983. https://www.510kdatabase.net/k823778/ 1983-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k823778-gamma-sterilized-capillary-flow-dialyz-fda-510k.jpg K823778 - GAMMA STERILIZED CAPILLARY FLOW DIALYZ K823778 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Jan 1983. https://www.510kdatabase.net/k823800/ 1983-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k823800-azlocillin-75mcg-sensi-disc-fda-510k.jpg K823800 - AZLOCILLIN 75MCG SENSI-DISC K823800 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jan 1983. https://www.510kdatabase.net/k823680/ 1983-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k823680-coat-a-count-morphine-kit-components-fda-510k.jpg K823680 - COAT-A-COUNT MORPHINE KIT & COMPONENTS K823680 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jan 1983. https://www.510kdatabase.net/k823697/ 1983-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k823697-prep-type-a-extraction-cartridge-fda-510k.jpg K823697 - PREP TYPE A EXTRACTION CARTRIDGE K823697 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Jan 1983. https://www.510kdatabase.net/k823731/ 1983-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k823731-cardf-fda-510k.jpg K823731 - CARDF K823731 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Jan 1983. https://www.510kdatabase.net/k823740/ 1983-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k823740-advance-system-emitaed-antiepileptic-fda-510k.jpg K823740 - ADVANCE SYSTEM EMITAED ANTIEPILEPTIC K823740 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Jan 1983. https://www.510kdatabase.net/k828564/ 1983-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k828564-computer-data-monitoring-system-fda-510k.jpg K828564 - COMPUTER DATA MONITORING SYSTEM K828564 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jan 1983. https://www.510kdatabase.net/k822944/ 1982-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k822944-gamma-dab125ipth-radioimmunoassay-kit-fda-510k.jpg K822944 - GAMMA DAB[125I]PTH RADIOIMMUNOASSAY KIT K822944 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Dec 1982. https://www.510kdatabase.net/k823290/ 1982-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k823290-neuromedics-pacetron-heart-rate-monitor-fda-510k.jpg K823290 - NEUROMEDICS PACETRON HEART RATE MONITOR K823290 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Dec 1982. https://www.510kdatabase.net/k823469/ 1982-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k823469-terufusion-three-way-stopcock-fda-510k.jpg K823469 - TERUFUSION THREE-WAY STOPCOCK K823469 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terumo Medical Corp.. Cleared Dec 1982. https://www.510kdatabase.net/k823533/ 1982-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k823533-jacket-set-fda-510k.jpg K823533 - JACKET & SET K823533 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Dec 1982. https://www.510kdatabase.net/k823566/ 1982-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k823566-immunoglobulin-control-fda-510k.jpg K823566 - IMMUNOGLOBULIN CONTROL K823566 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Dec 1982. https://www.510kdatabase.net/k823567/ 1982-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k823567-immunoglobulin-assays-igg-iga-igm-fda-510k.jpg K823567 - IMMUNOGLOBULIN ASSAYS-IGG, IGA, IGM K823567 is a FDA 510(k) cleared immunology medical device. Manufacturer: Syva Co.. Cleared Dec 1982. https://www.510kdatabase.net/k823608/ 1982-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k823608-pictures-word-identification-cva-pat-fda-510k.jpg K823608 - PICTURES & WORD IDENTIFICATION CVA PAT K823608 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1982. https://www.510kdatabase.net/k823612/ 1982-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k823612-adj-wooden-board-for-writing-fda-510k.jpg K823612 - ADJ. WOODEN BOARD FOR WRITING K823612 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1982. https://www.510kdatabase.net/k823622/ 1982-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k823622-insulated-thermoelastomer-mitt-fda-510k.jpg K823622 - INSULATED THERMOELASTOMER MITT K823622 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1982. https://www.510kdatabase.net/k823624/ 1982-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k823624-holder-for-mouth-stick-fda-510k.jpg K823624 - HOLDER FOR MOUTH STICK K823624 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1982. https://www.510kdatabase.net/k823625/ 1982-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k823625-mouth-stick-kit-fda-510k.jpg K823625 - MOUTH STICK KIT K823625 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1982. https://www.510kdatabase.net/k823626/ 1982-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k823626-disposable-tooth-brush-fda-510k.jpg K823626 - DISPOSABLE TOOTH BRUSH K823626 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1982. https://www.510kdatabase.net/k823629/ 1982-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k823629-formed-steel-device-keep-legs-separated-fda-510k.jpg K823629 - FORMED STEEL DEVICE KEEP LEGS SEPARATED K823629 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1982. https://www.510kdatabase.net/k821826/ 1982-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k821826-fep-ringed-gore-tex-vascular-graft-fda-510k.jpg K821826 - FEP-RINGED GORE-TEX@ VASCULAR GRAFT K821826 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Dec 1982. https://www.510kdatabase.net/k823123/ 1982-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k823123-cordia-cmv-fda-510k.jpg K823123 - CORDIA CMV K823123 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Cordis Corp.. Cleared Dec 1982. https://www.510kdatabase.net/k823267/ 1982-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k823267-factor-viii-related-antigen-rocket-eid-fda-510k.jpg K823267 - FACTOR VIII RELATED ANTIGEN ROCKET EID K823267 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Dec 1982. https://www.510kdatabase.net/k823368/ 1982-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k823368-dade-esr-kit-fda-510k.jpg K823368 - DADE ESR KIT K823368 is a FDA 510(k) cleared hematology medical device. Manufacturer: American Dade. Cleared Dec 1982. https://www.510kdatabase.net/k823462/ 1982-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k823462-single-vial-amylase-pnp-test-fda-510k.jpg K823462 - SINGLE VIAL AMYLASE PNP TEST K823462 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Dec 1982. https://www.510kdatabase.net/k823496/ 1982-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k823496-arthroscopic-irrigation-sets-2c403031-fda-510k.jpg K823496 - ARTHROSCOPIC IRRIGATION SETS-2C4030/31 K823496 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Dec 1982. https://www.510kdatabase.net/k823520/ 1982-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k823520-fibrosystem-fda-510k.jpg K823520 - FIBROSYSTEM K823520 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Dec 1982. https://www.510kdatabase.net/k823524/ 1982-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k823524-oxygen-concentrator-fda-510k.jpg K823524 - OXYGEN CONCENTRATOR K823524 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 1982. https://www.510kdatabase.net/k823548/ 1982-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k823548-compression-hip-screw-side-plate-fda-510k.jpg K823548 - COMPRESSION HIP SCREW SIDE-PLATE K823548 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Dec 1982. https://www.510kdatabase.net/k823603/ 1982-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k823603-formed-plastic-panty-hose-aid-fda-510k.jpg K823603 - FORMED PLASTIC PANTY HOSE AID K823603 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1982. https://www.510kdatabase.net/k823604/ 1982-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k823604-rod-whook-to-pull-clothes-on-fda-510k.jpg K823604 - ROD W/HOOK TO PULL CLOTHES ON K823604 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1982. https://www.510kdatabase.net/k823605/ 1982-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k823605-portable-electric-can-opener-fda-510k.jpg K823605 - PORTABLE ELECTRIC CAN OPENER K823605 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1982. https://www.510kdatabase.net/k823606/ 1982-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k823606-plastic-break-resistant-mirror-fda-510k.jpg K823606 - PLASTIC BREAK RESISTANT MIRROR K823606 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1982. https://www.510kdatabase.net/k823607/ 1982-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k823607-carpet-sweeper-fda-510k.jpg K823607 - CARPET SWEEPER K823607 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1982. https://www.510kdatabase.net/k823623/ 1982-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k823623-inflatable-heavy-plastic-exerciser-fda-510k.jpg K823623 - INFLATABLE HEAVY PLASTIC EXERCISER K823623 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1982. https://www.510kdatabase.net/k823627/ 1982-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k823627-leather-i-velcro-shoe-fastener-repair-fda-510k.jpg K823627 - LEATHER I VELCRO SHOE FASTENER REPAIR K823627 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1982. https://www.510kdatabase.net/k823628/ 1982-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k823628-leather-velcro-shoe-fastener-fda-510k.jpg K823628 - LEATHER & VELCRO SHOE FASTENER K823628 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1982. https://www.510kdatabase.net/k823632/ 1982-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k823632-long-handled-folding-hairbrush-fda-510k.jpg K823632 - LONG HANDLED FOLDING HAIRBRUSH K823632 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1982. https://www.510kdatabase.net/k823633/ 1982-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k823633-turners-for-knobs-fda-510k.jpg K823633 - TURNERS FOR KNOBS K823633 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1982. https://www.510kdatabase.net/k823634/ 1982-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k823634-chair-or-bed-leg-extenders-fda-510k.jpg K823634 - CHAIR OR BED LEG EXTENDERS K823634 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1982. https://www.510kdatabase.net/k823635/ 1982-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k823635-cushions-for-wheelchair-arms-fda-510k.jpg K823635 - CUSHIONS FOR WHEELCHAIR ARMS K823635 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1982. https://www.510kdatabase.net/k823636/ 1982-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k823636-arm-through-for-wheelchair-bk-6459-01-fda-510k.jpg K823636 - ARM THROUGH FOR WHEELCHAIR BK-6459-01 & K823636 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1982. https://www.510kdatabase.net/k823744/ 1982-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k823744-porcelain-artificial-teeth-fda-510k.jpg K823744 - PORCELAIN ARTIFICIAL TEETH K823744 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Dec 1982. https://www.510kdatabase.net/k821983/ 1982-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k821983-titan-gel-ldh-isoenzyme-kit-fda-510k.jpg K821983 - TITAN GEL LDH ISOENZYME KIT K821983 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Dec 1982. https://www.510kdatabase.net/k823281/ 1982-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k823281-model-rm-6000-61006200-polygraph-fda-510k.jpg K823281 - MODEL RM 6000, 6100,6200 POLYGRAPH K823281 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Dec 1982. https://www.510kdatabase.net/k823387/ 1982-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k823387-sopheia-gentamicin-eia-kit-fda-510k.jpg K823387 - SOPHEIA GENTAMICIN EIA KIT K823387 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Dec 1982. https://www.510kdatabase.net/k823484/ 1982-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k823484-thermal-dilution-catheter-fda-510k.jpg K823484 - THERMAL DILUTION CATHETER K823484 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Dec 1982. https://www.510kdatabase.net/k823594/ 1982-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k823594-plastic-built-up-handle-eating-utensils-fda-510k.jpg K823594 - PLASTIC BUILT-UP HANDLE EATING UTENSILS K823594 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1982. https://www.510kdatabase.net/k823595/ 1982-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k823595-head-support-for-wheelchair-fda-510k.jpg K823595 - HEAD SUPPORT FOR WHEELCHAIR K823595 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1982. https://www.510kdatabase.net/k823596/ 1982-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k823596-clamp-on-holder-for-a-glass-or-cup-fda-510k.jpg K823596 - CLAMP ON HOLDER FOR A GLASS OR CUP K823596 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1982. https://www.510kdatabase.net/k823600/ 1982-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k823600-solid-wood-cone-fda-510k.jpg K823600 - SOLID WOOD CONE K823600 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1982. https://www.510kdatabase.net/k823601/ 1982-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k823601-wrist-support-fda-510k.jpg K823601 - WRIST SUPPORT K823601 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1982. https://www.510kdatabase.net/k823602/ 1982-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k823602-regular-shoe-horn-wcylindrical-handle-fda-510k.jpg K823602 - REGULAR SHOE HORN W/CYLINDRICAL HANDLE K823602 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1982. https://www.510kdatabase.net/k823609/ 1982-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k823609-kit-of-words-ltrs-to-re-learn-bk4014-fda-510k.jpg K823609 - KIT OF WORDS & LTRS TO RE-LEARN-BK4014 K823609 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1982. https://www.510kdatabase.net/k823610/ 1982-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k823610-bk-4015-economy-communication-sheet-fda-510k.jpg K823610 - BK-4015 ECONOMY COMMUNICATION SHEET K823610 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1982. https://www.510kdatabase.net/k823613/ 1982-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k823613-plastic-stop-to-hold-telephone-button-fda-510k.jpg K823613 - PLASTIC STOP TO HOLD TELEPHONE BUTTON K823613 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1982. https://www.510kdatabase.net/k823614/ 1982-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k823614-flexible-holder-to-hold-phone-receiver-fda-510k.jpg K823614 - FLEXIBLE HOLDER TO HOLD PHONE RECEIVER K823614 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1982. https://www.510kdatabase.net/k823615/ 1982-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k823615-telephone-adaptor-persons-cant-answer-fda-510k.jpg K823615 - TELEPHONE ADAPTOR-PERSONS CANT ANSWER K823615 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1982. https://www.510kdatabase.net/k823616/ 1982-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k823616-plastic-slip-on-penpencil-holder-fda-510k.jpg K823616 - PLASTIC SLIP-ON PEN/PENCIL HOLDER K823616 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1982. https://www.510kdatabase.net/k823617/ 1982-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k823617-plastic-slip-on-points-wrubber-tip-for-fda-510k.jpg K823617 - PLASTIC SLIP-ON POINTS W/RUBBER TIP FOR K823617 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1982. https://www.510kdatabase.net/k823618/ 1982-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k823618-progressive-resistance-exercise-cuff-fda-510k.jpg K823618 - PROGRESSIVE RESISTANCE EXERCISE CUFF K823618 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1982. https://www.510kdatabase.net/k823619/ 1982-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k823619-plastic-elastomer-encased-in-terry-cloth-fda-510k.jpg K823619 - PLASTIC ELASTOMER ENCASED IN TERRY CLOTH K823619 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1982. https://www.510kdatabase.net/k823620/ 1982-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k823620-plastic-elastomer-in-cube-form-exercise-fda-510k.jpg K823620 - PLASTIC ELASTOMER IN CUBE FORM EXERCISE K823620 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1982. https://www.510kdatabase.net/k823678/ 1982-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k823678-telemetry-decoder-540-02-fda-510k.jpg K823678 - TELEMETRY DECODER #540-02 K823678 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Dec 1982. https://www.510kdatabase.net/k821951/ 1982-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k821951-datascope-model-83-iabp-system-fda-510k.jpg K821951 - DATASCOPE MODEL 83 IABP SYSTEM K821951 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Dec 1982. https://www.510kdatabase.net/k828544/ 1982-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k828544-maxicamera-400zs-fda-510k.jpg K828544 - MAXICAMERA 400ZS K828544 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Dec 1982. https://www.510kdatabase.net/k828545/ 1982-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k828545-maxicamera-500a-small-field-imaging-fda-510k.jpg K828545 - MAXICAMERA 500A SMALL FIELD IMAGING SYSTEM K828545 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Dec 1982. https://www.510kdatabase.net/k821669/ 1982-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k821669-ames-tda-gentamicin-test-fda-510k.jpg K821669 - AMES TDA GENTAMICIN TEST K821669 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Dec 1982. https://www.510kdatabase.net/k823010/ 1982-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k823010-micro-trak-chlamydia-trachomatis-cult-fda-510k.jpg K823010 - MICRO TRAK CHLAMYDIA TRACHOMATIS CULT K823010 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Syva Co.. Cleared Dec 1982. https://www.510kdatabase.net/k823202/ 1982-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k823202-free-total-estriol-kit-fda-510k.jpg K823202 - FREE & TOTAL ESTRIOL KIT K823202 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Dec 1982. https://www.510kdatabase.net/k823266/ 1982-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k823266-positive-id-system-fda-510k.jpg K823266 - POSITIVE I.D. SYSTEM K823266 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Dec 1982. https://www.510kdatabase.net/k823369/ 1982-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k823369-advance-emitr-tm-amikacin-control-fda-510k.jpg K823369 - ADVANCE EMIT(R) & TM AMIKACIN CONTROL K823369 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Dec 1982. https://www.510kdatabase.net/k823479/ 1982-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k823479-moduflex-neonatal-ventilator-set-fda-510k.jpg K823479 - MODUFLEX NEONATAL VENTILATOR SET K823479 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Dec 1982. https://www.510kdatabase.net/k823530/ 1982-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k823530-stimucord-external-neural-stim-911a-fda-510k.jpg K823530 - STIMUCORD EXTERNAL NEURAL STIM. 911A K823530 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cordis Corp.. Cleared Dec 1982. https://www.510kdatabase.net/k827176/ 1982-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k827176-model-640-linear-scanner-fda-510k.jpg K827176 - MODEL 640 LINEAR SCANNER K827176 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Dec 1982. https://www.510kdatabase.net/k828595/ 1982-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k828595-maxicamera-300a-small-field-of-view-fda-510k.jpg K828595 - MAXICAMERA 300A SMALL FIELD OF VIEW IMAGING SYSTEM K828595 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Dec 1982. https://www.510kdatabase.net/k823265/ 1982-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k823265-monoclonal-antibody-t4-radio-kit-fda-510k.jpg K823265 - MONOCLONAL ANTIBODY T4 RADIO-KIT K823265 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Dec 1982. https://www.510kdatabase.net/k823302/ 1982-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k823302-cholesterol-chod-pap-test-fda-510k.jpg K823302 - CHOLESTEROL CHOD-PAP TEST K823302 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Dec 1982. https://www.510kdatabase.net/k823374/ 1982-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k823374-oxygen-monitor-il-408-fda-510k.jpg K823374 - OXYGEN MONITOR IL 408 K823374 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Dec 1982. https://www.510kdatabase.net/k823415/ 1982-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k823415-prisma-c-reactive-protein-controls-fda-510k.jpg K823415 - PRISMA C-REACTIVE PROTEIN CONTROLS K823415 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Dec 1982. https://www.510kdatabase.net/k823416/ 1982-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k823416-prisma-c-reactive-protein-assay-fda-510k.jpg K823416 - PRISMA C-REACTIVE PROTEIN ASSAY K823416 is a FDA 510(k) cleared immunology medical device. Manufacturer: Syva Co.. Cleared Dec 1982. https://www.510kdatabase.net/k823417/ 1982-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k823417-prisma-c-reactive-protein-calibrators-fda-510k.jpg K823417 - PRISMA-C-REACTIVE PROTEIN CALIBRATORS K823417 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Dec 1982. https://www.510kdatabase.net/k823140/ 1982-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k823140-electroencephalograph-fda-510k.jpg K823140 - ELECTROENCEPHALOGRAPH K823140 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Dec 1982. https://www.510kdatabase.net/k823274/ 1982-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k823274-uni-tip-colostomy-irrigation-cone-fda-510k.jpg K823274 - UNI-TIP COLOSTOMY IRRIGATION CONE K823274 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Howmedica Corp.. Cleared Dec 1982. https://www.510kdatabase.net/k822733/ 1982-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k822733-sigma-reagent-system-no-885-fda-510k.jpg K822733 - SIGMA REAGENT SYSTEM NO. 885 K822733 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Chemical Co.. Cleared Dec 1982. https://www.510kdatabase.net/k823051/ 1982-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k823051-metal-knee-hip-prosthesis-fda-510k.jpg K823051 - METAL KNEE & HIP PROSTHESIS K823051 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Dec 1982. https://www.510kdatabase.net/k823370/ 1982-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k823370-advance-tm-emitr-tm-amikacin-assay-fda-510k.jpg K823370 - ADVANCE TM EMIT(R) & TM AMIKACIN ASSAY K823370 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Dec 1982. https://www.510kdatabase.net/k822781/ 1982-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k822781-medtronic-models-4011-4511-fda-510k.jpg K822781 - MEDTRONIC MODELS 4011 & 4511 K822781 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Nov 1982. https://www.510kdatabase.net/k822964/ 1982-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k822964-right-atrial-catheter-fda-510k.jpg K822964 - RIGHT ATRIAL CATHETER K822964 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quinton, Inc.. Cleared Nov 1982. https://www.510kdatabase.net/k823063/ 1982-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k823063-flo-gard-2000-enternal-pump-travasorb-fda-510k.jpg K823063 - FLO-GARD 2000 ENTERNAL PUMP & TRAVASORB K823063 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Nov 1982. https://www.510kdatabase.net/k823217/ 1982-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k823217-inpersol-peritoneal-dialsis-cycler-set-fda-510k.jpg K823217 - INPERSOL PERITONEAL DIALSIS CYCLER SET K823217 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1982. https://www.510kdatabase.net/k822849/ 1982-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k822849-raaf-dual-lumen-catheter-fda-510k.jpg K822849 - RAAF DUAL LUMEN CATHETER K822849 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quinton, Inc.. Cleared Nov 1982. https://www.510kdatabase.net/k822910/ 1982-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k822910-right-arterial-catheter-fda-510k.jpg K822910 - RIGHT ARTERIAL CATHETER K822910 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quinton, Inc.. Cleared Nov 1982. https://www.510kdatabase.net/k823112/ 1982-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k823112-clinistat-tda-series-fda-510k.jpg K823112 - CLINISTAT TDA SERIES K823112 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Nov 1982. https://www.510kdatabase.net/k823127/ 1982-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k823127-advance-emit-cad-procainamiden-acetyl-fda-510k.jpg K823127 - ADVANCE EMIT-CAD PROCAINAMIDE/N-ACETYL K823127 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Nov 1982. https://www.510kdatabase.net/k823128/ 1982-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k823128-advance-emit-cad-procainamide-assay-fda-510k.jpg K823128 - ADVANCE EMIT CAD PROCAINAMIDE ASSAY K823128 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Nov 1982. https://www.510kdatabase.net/k823129/ 1982-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k823129-advance-emit-cad-n-acetylprocainamide-fda-510k.jpg K823129 - ADVANCE EMIT-CAD N-ACETYLPROCAINAMIDE K823129 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Nov 1982. https://www.510kdatabase.net/k823196/ 1982-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k823196-special-control-serum-for-hdl-choles-fda-510k.jpg K823196 - SPECIAL CONTROL SERUM FOR HDL-CHOLES K823196 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Nov 1982. https://www.510kdatabase.net/k823201/ 1982-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k823201-human-placental-lactogen-kit-fda-510k.jpg K823201 - HUMAN PLACENTAL LACTOGEN KIT K823201 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Nov 1982. https://www.510kdatabase.net/k822704/ 1982-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k822704-model-366-07-adapt-aid-lead-adapter-fda-510k.jpg K822704 - MODEL 366-07 ADAPT AID LEAD ADAPTER K822704 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Nov 1982. https://www.510kdatabase.net/k823125/ 1982-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k823125-capiox-ii-fda-510k.jpg K823125 - CAPIOX II K823125 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Nov 1982. https://www.510kdatabase.net/k823210/ 1982-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k823210-model-525-neo-trak-neonatal-recorder-fda-510k.jpg K823210 - MODEL 525 NEO-TRAK NEONATAL RECORDER K823210 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Nov 1982. https://www.510kdatabase.net/k823220/ 1982-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k823220-cosmos-fda-510k.jpg K823220 - COSMOS K823220 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Nov 1982. https://www.510kdatabase.net/k823249/ 1982-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k823249-lifescope-iifour-fda-510k.jpg K823249 - LIFESCOPE II/FOUR K823249 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Nov 1982. https://www.510kdatabase.net/k823176/ 1982-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k823176-monoject-samplette-capillary-serum-sep-fda-510k.jpg K823176 - MONOJECT SAMPLETTE CAPILLARY SERUM SEP K823176 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sherwood Medical Co.. Cleared Nov 1982. https://www.510kdatabase.net/k823185/ 1982-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k823185-gamma-light-curing-dental-restorative-fda-510k.jpg K823185 - GAMMA LIGHT CURING DENTAL RESTORATIVE K823185 is a FDA 510(k) cleared dental medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Nov 1982. https://www.510kdatabase.net/k823213/ 1982-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k823213-diagnostics-alkaline-phosphatase-optimi-fda-510k.jpg K823213 - DIAGNOSTICS ALKALINE PHOSPHATASE OPTIMI K823213 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Nov 1982. https://www.510kdatabase.net/k823279/ 1982-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k823279-respond-quadriflex-3129-single-channel-fda-510k.jpg K823279 - RESPOND QUADRIFLEX #3129 SINGLE CHANNEL K823279 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Medtronic Vascular. Cleared Nov 1982. https://www.510kdatabase.net/k823087/ 1982-11-18 monthly 0.5 https://www.510kdatabase.net/og-image/k823087-boehringer-manneheim-diag-acid-phospha-fda-510k.jpg K823087 - BOEHRINGER MANNEHEIM DIAG. ACID PHOSPHA K823087 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Nov 1982. https://www.510kdatabase.net/k822977/ 1982-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k822977-hemoglobin-alc-by-column-test-fda-510k.jpg K822977 - HEMOGLOBIN ALC BY COLUMN TEST K822977 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bio-Rad. Cleared Nov 1982. https://www.510kdatabase.net/k823082/ 1982-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k823082-travasorb-nasogastric-nasointestinal-fda-510k.jpg K823082 - TRAVASORB NASOGASTRIC NASOINTESTINAL K823082 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Nov 1982. https://www.510kdatabase.net/k823110/ 1982-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k823110-qap-microcomputer-system-fda-510k.jpg K823110 - QAP MICROCOMPUTER SYSTEM K823110 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Nov 1982. https://www.510kdatabase.net/k822946/ 1982-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k822946-bactec-nap-tb-differentiation-test-fda-510k.jpg K822946 - BACTEC NAP TB DIFFERENTIATION TEST K822946 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Nov 1982. https://www.510kdatabase.net/k822984/ 1982-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k822984-id-zone-ld-isoenzyme-control-fda-510k.jpg K822984 - ID-ZONE LD ISOENZYME CONTROL K822984 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Nov 1982. https://www.510kdatabase.net/k823034/ 1982-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k823034-syva-advance-thyroxine-assay-fda-510k.jpg K823034 - SYVA ADVANCE THYROXINE ASSAY K823034 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Nov 1982. https://www.510kdatabase.net/k822728/ 1982-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k822728-solid-phase-simul-trac-vitamin-b12-fda-510k.jpg K822728 - SOLID PHASE SIMUL TRAC VITAMIN B12 K822728 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Nov 1982. https://www.510kdatabase.net/k822882/ 1982-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k822882-coat-a-count-free-thyroxine-kitcomponen-fda-510k.jpg K822882 - COAT-A-COUNT FREE THYROXINE KIT/COMPONEN K822882 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Nov 1982. https://www.510kdatabase.net/k822932/ 1982-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k822932-emit-clinical-processor-cp-5000-fda-510k.jpg K822932 - EMIT CLINICAL PROCESSOR #CP-5000 K822932 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Nov 1982. https://www.510kdatabase.net/k822958/ 1982-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k822958-lancer-msh-glucose-diag-kit-fda-510k.jpg K822958 - LANCER MSH GLUCOSE DIAG. KIT K822958 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sherwood Medical Co.. Cleared Nov 1982. https://www.510kdatabase.net/k822989/ 1982-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k822989-harvard-apparatus-single-speed-syringe-fda-510k.jpg K822989 - HARVARD APPARATUS SINGLE SPEED SYRINGE K822989 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 1982. https://www.510kdatabase.net/k821477/ 1982-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k821477-wm-harvey-h-1300-infantpediatric-blood-fda-510k.jpg K821477 - WM. HARVEY H-1300 INFANT/PEDIATRIC BLOOD K821477 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 1982. https://www.510kdatabase.net/k822124/ 1982-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k822124-titan-gel-cpk-isoenzyme-system-fda-510k.jpg K822124 - TITAN GEL CPK ISOENZYME SYSTEM K822124 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Nov 1982. https://www.510kdatabase.net/k822955/ 1982-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k822955-model-4242-tele-syst-arrhythmia-monitor-fda-510k.jpg K822955 - MODEL 4242 TELE SYST ARRHYTHMIA MONITOR K822955 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Nov 1982. https://www.510kdatabase.net/k822972/ 1982-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k822972-il-801-thermaldilution-cardiac-output-fda-510k.jpg K822972 - IL 801 THERMALDILUTION CARDIAC OUTPUT K822972 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Nov 1982. https://www.510kdatabase.net/k823037/ 1982-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k823037-pleur-evac-a-4005-system-fda-510k.jpg K823037 - PLEUR-EVAC A-4005 SYSTEM K823037 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Howmedica Corp.. Cleared Oct 1982. https://www.510kdatabase.net/k822827/ 1982-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k822827-hish-eia-diagnostic-kit-fda-510k.jpg K822827 - HISH EIA DIAGNOSTIC KIT K822827 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1982. https://www.510kdatabase.net/k822845/ 1982-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k822845-sopheia-cortisol-eia-kit-fda-510k.jpg K822845 - SOPHEIA CORTISOL EIA KIT K822845 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Oct 1982. https://www.510kdatabase.net/k822850/ 1982-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k822850-moni-tro-es-chemistry-control-level-ix-fda-510k.jpg K822850 - MONI-TRO ES CHEMISTRY CONTROL LEVEL IX K822850 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Oct 1982. https://www.510kdatabase.net/k822884/ 1982-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k822884-uric-acid-75cdo-fda-510k.jpg K822884 - URIC ACID 75CDO K822884 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Oct 1982. https://www.510kdatabase.net/k822933/ 1982-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k822933-syva-advance-emit-aed-valproic-acid-assa-fda-510k.jpg K822933 - SYVA ADVANCE EMIT AED VALPROIC ACID ASSA K822933 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Oct 1982. https://www.510kdatabase.net/k822934/ 1982-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k822934-syva-advance-emit-aed-valproic-acid-cont-fda-510k.jpg K822934 - SYVA ADVANCE EMIT AED VALPROIC ACID CONT K822934 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Oct 1982. https://www.510kdatabase.net/k822943/ 1982-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k822943-ellison-vitallium-fixation-staple-sys-fda-510k.jpg K822943 - ELLISON VITALLIUM FIXATION STAPLE SYS K822943 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Oct 1982. https://www.510kdatabase.net/k823003/ 1982-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k823003-q65-medical-treadmill-fda-510k.jpg K823003 - Q65 MEDICAL TREADMILL K823003 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Quinton, Inc.. Cleared Oct 1982. https://www.510kdatabase.net/k822241/ 1982-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k822241-folateb12-duo-bead-radioassay-fda-510k.jpg K822241 - FOLATE/B12 DUO-BEAD RADIOASSAY K822241 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1982. https://www.510kdatabase.net/k822794/ 1982-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k822794-respironics-endo-tube-control-sys-fda-510k.jpg K822794 - RESPIRONICS ENDO TUBE CONTROL SYS K822794 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Oct 1982. https://www.510kdatabase.net/k822039/ 1982-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k822039-beckman-astra-fda-510k.jpg K822039 - BECKMAN ASTRA K822039 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Oct 1982. https://www.510kdatabase.net/k822658/ 1982-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k822658-extension-set-type-dp-fda-510k.jpg K822658 - EXTENSION SET TYPE DP K822658 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1982. https://www.510kdatabase.net/k822712/ 1982-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k822712-inpersol-capd-adminis-set-type-dp-fda-510k.jpg K822712 - INPERSOL-CAPD ADMINIS. SET TYPE DP K822712 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1982. https://www.510kdatabase.net/k822759/ 1982-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k822759-abbott-laboratories-prolactin-eia-fda-510k.jpg K822759 - ABBOTT LABORATORIES PROLACTIN EIA K822759 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1982. https://www.510kdatabase.net/k820882/ 1982-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k820882-pecor-percor-dl-105-french-wsmec-fda-510k.jpg K820882 - PECOR, PERCOR-DL, 10.5 FRENCH W/SMEC K820882 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Oct 1982. https://www.510kdatabase.net/k822832/ 1982-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k822832-ticarcillin-75mcg-sensi-disc-fda-510k.jpg K822832 - TICARCILLIN 75MCG. SENSI-DISC K822832 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1982. https://www.510kdatabase.net/k822858/ 1982-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k822858-coat-a-count-tobramycin-ria-kit-fda-510k.jpg K822858 - COAT-A-COUNT TOBRAMYCIN RIA KIT K822858 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Oct 1982. https://www.510kdatabase.net/k822876/ 1982-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k822876-model-78534a-patient-monitor-fda-510k.jpg K822876 - MODEL 78534A PATIENT MONITOR K822876 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Oct 1982. https://www.510kdatabase.net/k822877/ 1982-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k822877-model-78554a-data-mgmt-plug-in-module-fda-510k.jpg K822877 - MODEL 78554A DATA MGMT. PLUG-IN MODULE K822877 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Oct 1982. https://www.510kdatabase.net/k822878/ 1982-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k822878-model-78553a-pressure-plug-in-module-fda-510k.jpg K822878 - MODEL 78553A PRESSURE PLUG-IN MODULE K822878 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Oct 1982. https://www.510kdatabase.net/k822695/ 1982-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k822695-signal-distribution-network-78581a-fda-510k.jpg K822695 - SIGNAL DISTRIBUTION NETWORK #78581A K822695 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Oct 1982. https://www.510kdatabase.net/k822625/ 1982-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k822625-syntevent-atomizernebulizer-aerosol-fda-510k.jpg K822625 - SYNTEVENT ATOMIZER/NEBULIZER AEROSOL K822625 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Syva Co.. Cleared Oct 1982. https://www.510kdatabase.net/k822710/ 1982-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k822710-metabolic-measurement-cart-fda-510k.jpg K822710 - METABOLIC MEASUREMENT CART K822710 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Oct 1982. https://www.510kdatabase.net/k822441/ 1982-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k822441-unimeter-330k-fda-510k.jpg K822441 - UNIMETER 330K K822441 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Oct 1982. https://www.510kdatabase.net/k822592/ 1982-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k822592-advance-tm-t-3-uptake-assay-fda-510k.jpg K822592 - ADVANCE TM T-3 UPTAKE ASSAY K822592 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Oct 1982. https://www.510kdatabase.net/k822701/ 1982-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k822701-fluorostat-fluorometer-fda-510k.jpg K822701 - FLUOROSTAT FLUOROMETER K822701 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Oct 1982. https://www.510kdatabase.net/k822808/ 1982-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k822808-tdx-kenamycin-fda-510k.jpg K822808 - TDX KENAMYCIN K822808 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1982. https://www.510kdatabase.net/k822297/ 1982-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k822297-enertrax-model-7100e-fda-510k.jpg K822297 - ENERTRAX MODEL 7100E K822297 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Oct 1982. https://www.510kdatabase.net/k822630/ 1982-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k822630-monoject-plastic-hub-spinal-needle-fda-510k.jpg K822630 - MONOJECT PLASTIC HUB SPINAL NEEDLE K822630 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sherwood Medical Co.. Cleared Oct 1982. https://www.510kdatabase.net/k822231/ 1982-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k822231-aca-urinary-protein-analytical-test-pack-fda-510k.jpg K822231 - ACA URINARY PROTEIN ANALYTICAL TEST PACK K822231 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Sep 1982. https://www.510kdatabase.net/k822646/ 1982-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k822646-quantaphos-acid-phosphatose-cont-serum-fda-510k.jpg K822646 - QUANTAPHOS ACID PHOSPHATOSE CONT. SERUM K822646 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Sep 1982. https://www.510kdatabase.net/k827891/ 1982-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k827891-ultrasonic-pulsed-echo-imaging-system-fda-510k.jpg K827891 - ULTRASONIC PULSED ECHO IMAGING SYSTEM RT30 K827891 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Sep 1982. https://www.510kdatabase.net/k827928/ 1982-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k827928-vrt-table-fda-510k.jpg K827928 - VRT TABLE K827928 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Sep 1982. https://www.510kdatabase.net/k828055/ 1982-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k828055-mammomat-b-and-be-fda-510k.jpg K828055 - MAMMOMAT B AND BE K828055 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 1982. https://www.510kdatabase.net/k822653/ 1982-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k822653-tdx-quinidine-fda-510k.jpg K822653 - TDX QUINIDINE K822653 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1982. https://www.510kdatabase.net/k822657/ 1982-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k822657-emit-amd-amikacin-assay-fda-510k.jpg K822657 - EMIT-AMD AMIKACIN ASSAY K822657 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Dade Behring, Inc.. Cleared Sep 1982. https://www.510kdatabase.net/k822714/ 1982-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k822714-conclude-composite-luting-cement-fda-510k.jpg K822714 - CONCLUDE COMPOSITE LUTING CEMENT K822714 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Sep 1982. https://www.510kdatabase.net/k822600/ 1982-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k822600-neuromedics-orions-660-01-fda-510k.jpg K822600 - NEUROMEDICS ORIONS #660-01 K822600 is a FDA 510(k) cleared neurology medical device. Manufacturer: Intermedics, Inc.. Cleared Sep 1982. https://www.510kdatabase.net/k822345/ 1982-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k822345-disposable-linear-stapler-lsf-fda-510k.jpg K822345 - DISPOSABLE LINEAR STAPLER (LSF) K822345 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Sep 1982. https://www.510kdatabase.net/k822405/ 1982-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k822405-conductive-adhesive-dispersive-electro-fda-510k.jpg K822405 - CONDUCTIVE ADHESIVE DISPERSIVE ELECTRO K822405 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Sep 1982. https://www.510kdatabase.net/k822487/ 1982-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k822487-minitek-gram-positive-broth-set-and-fda-510k.jpg K822487 - MINITEK GRAM-POSITIVE BROTH & SET AND K822487 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1982. https://www.510kdatabase.net/k822587/ 1982-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k822587-advance-emit-cad-quinidine-control-fda-510k.jpg K822587 - ADVANCE EMIT-CAD QUINIDINE CONTROL K822587 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Sep 1982. https://www.510kdatabase.net/k822588/ 1982-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k822588-advance-emit-cad-quinidine-assay-fda-510k.jpg K822588 - ADVANCE EMIT-CAD QUINIDINE ASSAY K822588 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Sep 1982. https://www.510kdatabase.net/k821797/ 1982-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k821797-actisorb-activated-charcoal-cloth-drsg-fda-510k.jpg K821797 - ACTISORB* ACTIVATED CHARCOAL CLOTH DRSG. K821797 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Sep 1982. https://www.510kdatabase.net/k821803/ 1982-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k821803-qbc-centrifugal-hematology-system-fda-510k.jpg K821803 - QBC CENTRIFUGAL HEMATOLOGY SYSTEM K821803 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1982. https://www.510kdatabase.net/k821893/ 1982-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k821893-zimmer-metal-backed-acetabular-cup-fda-510k.jpg K821893 - ZIMMER METAL BACKED ACETABULAR CUP K821893 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Sep 1982. https://www.510kdatabase.net/k822445/ 1982-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k822445-hct-centrifuge-fda-510k.jpg K822445 - HCT CENTRIFUGE K822445 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Sep 1982. https://www.510kdatabase.net/k822450/ 1982-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k822450-aurafill-dental-restorative-fda-510k.jpg K822450 - AURAFILL* DENTAL RESTORATIVE K822450 is a FDA 510(k) cleared dental medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Sep 1982. https://www.510kdatabase.net/k822466/ 1982-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k822466-thrombin-time-test-fda-510k.jpg K822466 - THROMBIN TIME TEST K822466 is a FDA 510(k) cleared hematology medical device. Manufacturer: American Dade. Cleared Sep 1982. https://www.510kdatabase.net/k822517/ 1982-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k822517-single-channel-nonfade-oscilloscope-fda-510k.jpg K822517 - SINGLE CHANNEL NONFADE OSCILLOSCOPE K822517 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Sep 1982. https://www.510kdatabase.net/k827929/ 1982-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k827929-mobilett-mobile-x-ray-unit-fda-510k.jpg K827929 - MOBILETT, MOBILE X-RAY UNIT K827929 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Sep 1982. https://www.510kdatabase.net/k822025/ 1982-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k822025-automatic-splicing-device-fda-510k.jpg K822025 - AUTOMATIC SPLICING DEVICE K822025 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Sep 1982. https://www.510kdatabase.net/k822631/ 1982-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k822631-argyle-duo-tube-fda-510k.jpg K822631 - ARGYLE DUO-TUBE K822631 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Sherwood Medical Co.. Cleared Sep 1982. https://www.510kdatabase.net/k822328/ 1982-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k822328-il-301-transcutaneous-oxygen-monitor-fda-510k.jpg K822328 - IL 301 TRANSCUTANEOUS OXYGEN MONITOR K822328 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 1982. https://www.510kdatabase.net/k822451/ 1982-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k822451-aurafill-dental-restorative-bonding-ag-fda-510k.jpg K822451 - AURAFILL* DENTAL RESTORATIVE BONDING AG. K822451 is a FDA 510(k) cleared dental medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Sep 1982. https://www.510kdatabase.net/k822329/ 1982-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k822329-antituberculous-drugs-sire-fda-510k.jpg K822329 - ANTITUBERCULOUS DRUGS (SIRE) K822329 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1982. https://www.510kdatabase.net/k822330/ 1982-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k822330-bactec-diluting-fluid-fda-510k.jpg K822330 - BACTEC DILUTING FLUID K822330 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1982. https://www.510kdatabase.net/k822343/ 1982-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k822343-b-hcg-fda-510k.jpg K822343 - B-HCG K822343 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Sep 1982. https://www.510kdatabase.net/k827889/ 1982-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k827889-kodak-kodaflex-film-fda-510k.jpg K827889 - KODAK KODAFLEX FILM K827889 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Sep 1982. https://www.510kdatabase.net/k820635/ 1982-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k820635-pvp-gel-dressing-fda-510k.jpg K820635 - PVP GEL DRESSING K820635 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Aug 1982. https://www.510kdatabase.net/k821716/ 1982-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k821716-bard-ptfe-vascular-prosthesis-fda-510k.jpg K821716 - BARD PTFE VASCULAR PROSTHESIS K821716 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Aug 1982. https://www.510kdatabase.net/k822317/ 1982-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k822317-argyle-carotid-artery-loop-shunt-fda-510k.jpg K822317 - ARGYLE CAROTID ARTERY LOOP SHUNT K822317 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sherwood Medical Co.. Cleared Aug 1982. https://www.510kdatabase.net/k821150/ 1982-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k821150-nu-gauze-sponge-fda-510k.jpg K821150 - NU-GAUZE SPONGE K821150 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Aug 1982. https://www.510kdatabase.net/k822050/ 1982-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k822050-stirring-assembly-for-digispec-x-spectro-fda-510k.jpg K822050 - STIRRING ASSEMBLY FOR DIGISPEC X SPECTRO K822050 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Aug 1982. https://www.510kdatabase.net/k822209/ 1982-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k822209-autolancet-fda-510k.jpg K822209 - AUTOLANCET K822209 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1982. https://www.510kdatabase.net/k822291/ 1982-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k822291-quantimune-htsh-irma-fda-510k.jpg K822291 - QUANTIMUNE HTSH IRMA K822291 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Aug 1982. https://www.510kdatabase.net/k822318/ 1982-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k822318-argyle-mediastinal-drain-fda-510k.jpg K822318 - ARGYLE MEDIASTINAL DRAIN K822318 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sherwood Medical Co.. Cleared Aug 1982. https://www.510kdatabase.net/k822381/ 1982-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k822381-syva-lab-processor-6000-fda-510k.jpg K822381 - SYVA LAB PROCESSOR 6000 K822381 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Aug 1982. https://www.510kdatabase.net/k821758/ 1982-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k821758-quinton-q-scan-models-900-901-fda-510k.jpg K821758 - QUINTON Q, SCAN MODELS 900 & 901 K821758 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Aug 1982. https://www.510kdatabase.net/k822292/ 1982-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k822292-disposable-dispensing-spread-pipets-fda-510k.jpg K822292 - DISPOSABLE DISPENSING-SPREAD PIPETS K822292 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Aug 1982. https://www.510kdatabase.net/k822155/ 1982-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k822155-ethicon-temporary-cardiac-pacing-wire-fda-510k.jpg K822155 - ETHICON TEMPORARY CARDIAC PACING WIRE K822155 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Ethicon, Inc.. Cleared Aug 1982. https://www.510kdatabase.net/k822313/ 1982-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k822313-procedure-430-reagents-for-acetamin-fda-510k.jpg K822313 - PROCEDURE #430 & REAGENTS FOR ACETAMIN K822313 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Aug 1982. https://www.510kdatabase.net/k827815/ 1982-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k827815-sonoline-6000-fda-510k.jpg K827815 - SONOLINE 6000 K827815 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 1982. https://www.510kdatabase.net/k827858/ 1982-08-24 monthly 0.5 https://www.510kdatabase.net/og-image/k827858-model-835-spot-film-device-fda-510k.jpg K827858 - MODEL 835 SPOT FILM DEVICE K827858 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Aug 1982. https://www.510kdatabase.net/k820811/ 1982-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k820811-proximate-disposable-skin-staplers-fda-510k.jpg K820811 - PROXIMATE DISPOSABLE SKIN STAPLERS K820811 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Aug 1982. https://www.510kdatabase.net/k821713/ 1982-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k821713-porocoat-low-profile-metal-backed-cup-fda-510k.jpg K821713 - POROCOAT LOW PROFILE METAL BACKED CUP K821713 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Aug 1982. https://www.510kdatabase.net/k821714/ 1982-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k821714-porocoat-standard-metal-backed-cup-fda-510k.jpg K821714 - POROCOAT STANDARD METAL BACKED CUP K821714 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Aug 1982. https://www.510kdatabase.net/k821065/ 1982-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k821065-datascope-105-french-intra-aortic-bal-fda-510k.jpg K821065 - DATASCOPE 10.5 FRENCH INTRA-AORTIC BAL K821065 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Aug 1982. https://www.510kdatabase.net/k821982/ 1982-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k821982-titan-gel-serum-control-fda-510k.jpg K821982 - TITAN GEL SERUM CONTROL K821982 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Aug 1982. https://www.510kdatabase.net/k822083/ 1982-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k822083-u-100-insulin-syringe-fda-510k.jpg K822083 - U-100 INSULIN SYRINGE K822083 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terumo Medical Corp.. Cleared Aug 1982. https://www.510kdatabase.net/k822094/ 1982-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k822094-dental-matrix-band-fda-510k.jpg K822094 - DENTAL MATRIX BAND K822094 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Aug 1982. https://www.510kdatabase.net/k822232/ 1982-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k822232-aca-urinary-protein-calibrator-fda-510k.jpg K822232 - ACA URINARY PROTEIN CALIBRATOR K822232 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Aug 1982. https://www.510kdatabase.net/k822361/ 1982-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k822361-dianeal-solution-exchange-device-5c4193-fda-510k.jpg K822361 - DIANEAL SOLUTION EXCHANGE DEVICE #5C4193 K822361 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Aug 1982. https://www.510kdatabase.net/k827503/ 1982-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k827503-sonoline-1000-8008-and-8080-fda-510k.jpg K827503 - SONOLINE 1000, 8008 AND 8080 K827503 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 1982. https://www.510kdatabase.net/k827792/ 1982-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k827792-siremobile-3-fda-510k.jpg K827792 - SIREMOBILE 3 K827792 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Aug 1982. https://www.510kdatabase.net/k821752/ 1982-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k821752-synthograft-lg-augmentation-bone-fill-fda-510k.jpg K821752 - SYNTHOGRAFT LG-AUGMENTATION & BONE FILL K821752 is a FDA 510(k) cleared dental medical device. Manufacturer: Depuy, Inc.. Cleared Aug 1982. https://www.510kdatabase.net/k821993/ 1982-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k821993-shiley-laryngectomy-tube-fda-510k.jpg K821993 - SHILEY LARYNGECTOMY TUBE K821993 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Shiley, Inc.. Cleared Aug 1982. https://www.510kdatabase.net/k822395/ 1982-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k822395-cf-1211-capillary-flow-dialyzer-code-fda-510k.jpg K822395 - CF 1211 CAPILLARY FLOW DIALYZER CODE K822395 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Aug 1982. https://www.510kdatabase.net/k827760/ 1982-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k827760-digital-fluorographic-x-ray-system-fda-510k.jpg K827760 - DIGITAL FLUOROGRAPHIC X-RAY SYSTEM K827760 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Aug 1982. https://www.510kdatabase.net/k820989/ 1982-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k820989-medtronic-6993-fda-510k.jpg K820989 - MEDTRONIC #6993 K820989 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Aug 1982. https://www.510kdatabase.net/k821246/ 1982-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k821246-melolin-fda-510k.jpg K821246 - MELOLIN K821246 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Aug 1982. https://www.510kdatabase.net/k821538/ 1982-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k821538-capiox-cr-cardiotomy-reservoir-fda-510k.jpg K821538 - CAPIOX CR-CARDIOTOMY RESERVOIR K821538 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Aug 1982. https://www.510kdatabase.net/k821889/ 1982-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k821889-porous-surfaced-platinum-iridium-fda-510k.jpg K821889 - POROUS SURFACED PLATINUM IRIDIUM K821889 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Aug 1982. https://www.510kdatabase.net/k822147/ 1982-08-06 monthly 0.5 https://www.510kdatabase.net/og-image/k822147-medtronic-enertrax-model-7100-fda-510k.jpg K822147 - MEDTRONIC ENERTRAX MODEL 7100 K822147 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Aug 1982. https://www.510kdatabase.net/k822123/ 1982-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k822123-isopropanol-hemoglobin-stability-test-fda-510k.jpg K822123 - ISOPROPANOL HEMOGLOBIN STABILITY TEST K822123 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Aug 1982. https://www.510kdatabase.net/k822132/ 1982-08-05 monthly 0.5 https://www.510kdatabase.net/og-image/k822132-dade-chill-tray-fda-510k.jpg K822132 - DADE CHILL TRAY K822132 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Aug 1982. https://www.510kdatabase.net/k821994/ 1982-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k821994-disposable-linear-stapler-lsr-fda-510k.jpg K821994 - DISPOSABLE LINEAR STAPLER-(LSR) K821994 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Aug 1982. https://www.510kdatabase.net/k822026/ 1982-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k822026-immuno-diagnostics-assay-fda-510k.jpg K822026 - IMMUNO DIAGNOSTICS ASSAY K822026 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Aug 1982. https://www.510kdatabase.net/k822134/ 1982-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k822134-shiely-duel-lumen-subclavian-cannula-fda-510k.jpg K822134 - SHIELY DUEL LUMEN SUBCLAVIAN CANNULA K822134 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Shiley, Inc.. Cleared Aug 1982. https://www.510kdatabase.net/k821013/ 1982-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k821013-ivex-hp-pediatric-extension-set-sl-fda-510k.jpg K821013 - IVEX-HP PEDIATRIC EXTENSION SET-SL K821013 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Jul 1982. https://www.510kdatabase.net/k821445/ 1982-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k821445-argyle-ferguson-left-atrial-vent-cath-fda-510k.jpg K821445 - ARGYLE FERGUSON LEFT ATRIAL VENT CATH K821445 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sherwood Medical Co.. Cleared Jul 1982. https://www.510kdatabase.net/k821960/ 1982-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k821960-bbl-pneumoslide-test-fda-510k.jpg K821960 - BBL PNEUMOSLIDE TEST K821960 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jul 1982. https://www.510kdatabase.net/k821962/ 1982-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k821962-bbl-staphyslide-test-fda-510k.jpg K821962 - BBL STAPHYSLIDE TEST K821962 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jul 1982. https://www.510kdatabase.net/k822044/ 1982-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k822044-seralyzer-hemoglobin-reagent-strips-fda-510k.jpg K822044 - SERALYZER HEMOGLOBIN REAGENT STRIPS K822044 is a FDA 510(k) cleared hematology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Jul 1982. https://www.510kdatabase.net/k822045/ 1982-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k822045-seralyzer-hemoglobin-test-module-fda-510k.jpg K822045 - SERALYZER HEMOGLOBIN TEST MODULE K822045 is a FDA 510(k) cleared hematology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Jul 1982. https://www.510kdatabase.net/k822046/ 1982-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k822046-seralyzer-hemoglobin-calibrators-fda-510k.jpg K822046 - SERALYZER HEMOGLOBIN CALIBRATORS K822046 is a FDA 510(k) cleared hematology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Jul 1982. https://www.510kdatabase.net/k822029/ 1982-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k822029-monojet-520-20cc-syringes-wneedles-fda-510k.jpg K822029 - MONOJET 520 20CC SYRINGES W/NEEDLES K822029 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Jul 1982. https://www.510kdatabase.net/k822051/ 1982-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k822051-emit-dav-methaqualone-assay-fda-510k.jpg K822051 - EMIT D.A.V. METHAQUALONE ASSAY K822051 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jul 1982. https://www.510kdatabase.net/k822052/ 1982-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k822052-emit-dav-methaqualone-urine-calibra-fda-510k.jpg K822052 - EMIT D.A.V. METHAQUALONE URINE CALIBRA K822052 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jul 1982. https://www.510kdatabase.net/k822067/ 1982-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k822067-emit-c-reactive-protein-autocarousel-fda-510k.jpg K822067 - EMIT C-REACTIVE PROTEIN AUTOCAROUSEL K822067 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Jul 1982. https://www.510kdatabase.net/k822078/ 1982-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k822078-dade-disp-dispensing-spreading-pipets-fda-510k.jpg K822078 - DADE DISP. DISPENSING-SPREADING PIPETS K822078 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Jul 1982. https://www.510kdatabase.net/k821412/ 1982-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k821412-c-reactive-protein-control-fda-510k.jpg K821412 - C-REACTIVE PROTEIN CONTROL K821412 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Jul 1982. https://www.510kdatabase.net/k821981/ 1982-07-22 monthly 0.5 https://www.510kdatabase.net/og-image/k821981-titan-gel-cpkldh-isoenzyme-control-fda-510k.jpg K821981 - TITAN GEL CPK/LDH ISOENZYME CONTROL K821981 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Jul 1982. https://www.510kdatabase.net/k821970/ 1982-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k821970-dynacor-urethral-catheter-tray-fda-510k.jpg K821970 - DYNACOR URETHRAL CATHETER TRAY K821970 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medline Industries, Inc.. Cleared Jul 1982. https://www.510kdatabase.net/k821946/ 1982-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k821946-alt-enzyme-assay-kit-fda-510k.jpg K821946 - ALT ENZYME ASSAY KIT K821946 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Jul 1982. https://www.510kdatabase.net/k821950/ 1982-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k821950-q-pak-urine-toxicology-control-unassayed-fda-510k.jpg K821950 - Q-PAK URINE TOXICOLOGY CONTROL UNASSAYED K821950 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Jul 1982. https://www.510kdatabase.net/k821971/ 1982-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k821971-valuline-amalgam-alloy-fda-510k.jpg K821971 - VALULINE* AMALGAM ALLOY K821971 is a FDA 510(k) cleared dental medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jul 1982. https://www.510kdatabase.net/k821973/ 1982-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k821973-q-pak-urine-toxicology-control-unassay-fda-510k.jpg K821973 - Q-PAK URINE TOXICOLOGY CONTROL, UNASSAY. K821973 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Jul 1982. https://www.510kdatabase.net/k821937/ 1982-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k821937-syva-advance-standardization-kit-2-fda-510k.jpg K821937 - SYVA ADVANCE STANDARDIZATION KIT #2 K821937 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Jul 1982. https://www.510kdatabase.net/k821938/ 1982-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k821938-syva-advance-standardization-kit-3-fda-510k.jpg K821938 - SYVA ADVANCE STANDARDIZATION KIT #3 K821938 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Jul 1982. https://www.510kdatabase.net/k821324/ 1982-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k821324-argyle-intramedicut-catheter-kit-fda-510k.jpg K821324 - ARGYLE INTRAMEDICUT CATHETER KIT K821324 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sherwood Medical Co.. Cleared Jul 1982. https://www.510kdatabase.net/k821909/ 1982-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k821909-littman-tunable-stethoscope-2136-fda-510k.jpg K821909 - LITTMAN TUNABLE STETHOSCOPE 2136 K821909 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: 3M Company. Cleared Jul 1982. https://www.510kdatabase.net/k821732/ 1982-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k821732-argyle-gerzof-abcess-drainage-catheter-fda-510k.jpg K821732 - ARGYLE GERZOF ABCESS DRAINAGE CATHETER K821732 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sherwood Medical Co.. Cleared Jul 1982. https://www.510kdatabase.net/k827543/ 1982-07-09 monthly 0.5 https://www.510kdatabase.net/og-image/k827543-maxicamera-model-200a-fda-510k.jpg K827543 - MAXICAMERA MODEL 200A K827543 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jul 1982. https://www.510kdatabase.net/k820524/ 1982-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k820524-clirans-hollow-fiber-dialyzers-fda-510k.jpg K820524 - CLIRANS HOLLOW FIBER DIALYZERS K820524 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Terumo Medical Corp.. Cleared Jul 1982. https://www.510kdatabase.net/k821726/ 1982-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k821726-model-535-02-trace-a-pace-transmitter-fda-510k.jpg K821726 - MODEL 535-02 TRACE-A-PACE TRANSMITTER K821726 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Jul 1982. https://www.510kdatabase.net/k821861/ 1982-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k821861-coat-a-count-insulin-kit-fda-510k.jpg K821861 - COAT-A-COUNT INSULIN KIT K821861 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jul 1982. https://www.510kdatabase.net/k827455/ 1982-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k827455-sonoline-3000-fda-510k.jpg K827455 - SONOLINE 3000 K827455 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Jul 1982. https://www.510kdatabase.net/k821738/ 1982-07-06 monthly 0.5 https://www.510kdatabase.net/og-image/k821738-clini-tek-semi-automated-urinalysis-syst-fda-510k.jpg K821738 - CLINI-TEK SEMI-AUTOMATED URINALYSIS SYST K821738 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Jul 1982. https://www.510kdatabase.net/k820957/ 1982-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k820957-suface-replacement-elbow-fda-510k.jpg K820957 - SUFACE REPLACEMENT ELBOW K820957 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jul 1982. https://www.510kdatabase.net/k821271/ 1982-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k821271-bard-protective-barrier-film-fda-510k.jpg K821271 - BARD PROTECTIVE BARRIER FILM K821271 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jul 1982. https://www.510kdatabase.net/k821693/ 1982-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k821693-j-j-dip-water-additive-fda-510k.jpg K821693 - J & J DIP WATER ADDITIVE K821693 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jul 1982. https://www.510kdatabase.net/k821743/ 1982-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k821743-emit-tox-serum-tricyclic-antidepr-assay-fda-510k.jpg K821743 - EMIT-TOX SERUM TRICYCLIC ANTIDEPR. ASSAY K821743 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jul 1982. https://www.510kdatabase.net/k821757/ 1982-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k821757-quik-prep2-electrode-fda-510k.jpg K821757 - QUIK - PREP2 ELECTRODE K821757 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Jul 1982. https://www.510kdatabase.net/k821805/ 1982-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k821805-pyridoxal-5-phosphate-stripes-fda-510k.jpg K821805 - PYRIDOXAL-5-PHOSPHATE STRIPES K821805 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jul 1982. https://www.510kdatabase.net/k821812/ 1982-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k821812-beckman-uric-acid-reagent-fda-510k.jpg K821812 - BECKMAN URIC ACID REAGENT K821812 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jul 1982. https://www.510kdatabase.net/k821813/ 1982-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k821813-beckman-uric-acid-standard-fda-510k.jpg K821813 - BECKMAN URIC ACID STANDARD K821813 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jul 1982. https://www.510kdatabase.net/k821852/ 1982-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k821852-diagnostics-hdl-cholesterol-precipitant-fda-510k.jpg K821852 - DIAGNOSTICS HDL CHOLESTEROL PRECIPITANT K821852 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jul 1982. https://www.510kdatabase.net/k821855/ 1982-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k821855-visco-handex-various-models-fda-510k.jpg K821855 - VISCO HANDEX-VARIOUS MODELS K821855 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jul 1982. https://www.510kdatabase.net/k821856/ 1982-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k821856-bk-2082-folding-stocking-aid-fda-510k.jpg K821856 - BK-2082 FOLDING STOCKING AID K821856 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jul 1982. https://www.510kdatabase.net/k821857/ 1982-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k821857-bk-5305-multiple-hand-grid-fda-510k.jpg K821857 - BK-5305 MULTIPLE HAND GRID K821857 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jul 1982. https://www.510kdatabase.net/k821858/ 1982-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k821858-notie-stretch-lace-various-models-fda-510k.jpg K821858 - NOTIE STRETCH-LACE-VARIOUS MODELS K821858 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jul 1982. https://www.510kdatabase.net/k821859/ 1982-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k821859-ortholace-456-eyelet-fda-510k.jpg K821859 - ORTHOLACE 4,5.6 EYELET K821859 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jul 1982. https://www.510kdatabase.net/k821860/ 1982-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k821860-bk-6477-the-derby-raised-toilet-seat-fda-510k.jpg K821860 - BK-6477 THE DERBY RAISED TOILET SEAT K821860 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jul 1982. https://www.510kdatabase.net/k820546/ 1982-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k820546-card-uv-germicidal-chamber-ii-fda-510k.jpg K820546 - CARD U.V. GERMICIDAL CHAMBER II K820546 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Jun 1982. https://www.510kdatabase.net/k821186/ 1982-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k821186-penetrak-tm-fda-510k.jpg K821186 - PENETRAK TM K821186 is a FDA 510(k) cleared hematology medical device. Manufacturer: Syva Co.. Cleared Jun 1982. https://www.510kdatabase.net/k821767/ 1982-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k821767-emit-st-urine-methagualone-calibrator-fda-510k.jpg K821767 - EMIT ST URINE METHAGUALONE CALIBRATOR K821767 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jun 1982. https://www.510kdatabase.net/k821771/ 1982-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k821771-macro-vue-card-test-amikacin-fda-510k.jpg K821771 - MACRO-VUE CARD TEST, AMIKACIN K821771 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jun 1982. https://www.510kdatabase.net/k821815/ 1982-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k821815-advance-c-reactive-protein-crp-assay-fda-510k.jpg K821815 - ADVANCE C-REACTIVE PROTEIN (CRP) ASSAY K821815 is a FDA 510(k) cleared immunology medical device. Manufacturer: Syva Co.. Cleared Jun 1982. https://www.510kdatabase.net/k821632/ 1982-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k821632-surgical-scissors-set-of-3-fda-510k.jpg K821632 - SURGICAL SCISSORS, SET OF 3 K821632 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jun 1982. https://www.510kdatabase.net/k821670/ 1982-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k821670-argyle-tartan-i-tracheal-tube-fda-510k.jpg K821670 - ARGYLE TARTAN I TRACHEAL TUBE K821670 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sherwood Medical Co.. Cleared Jun 1982. https://www.510kdatabase.net/k821745/ 1982-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k821745-bardex-all-silicone-pediatric-catheter-fda-510k.jpg K821745 - BARDEX ALL SILICONE PEDIATRIC CATHETER K821745 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jun 1982. https://www.510kdatabase.net/k821766/ 1982-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k821766-emit-st-urine-methagualone-controls-fda-510k.jpg K821766 - EMIT - ST URINE METHAGUALONE CONTROLS K821766 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jun 1982. https://www.510kdatabase.net/k821768/ 1982-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k821768-emit-st-urine-methagualone-assay-fda-510k.jpg K821768 - EMIT ST URINE METHAGUALONE ASSAY K821768 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Jun 1982. https://www.510kdatabase.net/k820743/ 1982-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k820743-hollow-fiber-dialyzers-fda-510k.jpg K820743 - HOLLOW FIBER DIALYZERS K820743 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Terumo Medical Corp.. Cleared Jun 1982. https://www.510kdatabase.net/k820988/ 1982-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k820988-medtronic-1992-2-dual-rate-transmitter-fda-510k.jpg K820988 - MEDTRONIC #1992-2 DUAL RATE TRANSMITTER K820988 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Jun 1982. https://www.510kdatabase.net/k821400/ 1982-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k821400-mahurkar-subclavian-catheter-fda-510k.jpg K821400 - MAHURKAR SUBCLAVIAN CATHETER K821400 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quinton, Inc.. Cleared Jun 1982. https://www.510kdatabase.net/k821476/ 1982-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k821476-bard-endo-link-intracondylar-rotating-fda-510k.jpg K821476 - BARD ENDO LINK INTRACONDYLAR ROTATING K821476 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jun 1982. https://www.510kdatabase.net/k821252/ 1982-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k821252-hoffman-universal-foot-support-fda-510k.jpg K821252 - HOFFMAN UNIVERSAL FOOT SUPPORT K821252 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jun 1982. https://www.510kdatabase.net/k821264/ 1982-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k821264-cefoperazone-75mcg-sensi-disc-fda-510k.jpg K821264 - CEFOPERAZONE 75MCG SENSI-DISC K821264 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jun 1982. https://www.510kdatabase.net/k821272/ 1982-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k821272-bn-74-coated-bardex-all-silicone-cath-fda-510k.jpg K821272 - BN-74 COATED BARDEX ALL SILICONE CATH K821272 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jun 1982. https://www.510kdatabase.net/k821578/ 1982-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k821578-venoset-dual-rate-piggyback-wivex-fda-510k.jpg K821578 - VENOSET DUAL-RATE PIGGYBACK W/IVEX & K821578 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1982. https://www.510kdatabase.net/k821661/ 1982-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k821661-flexiflo-ii-fda-510k.jpg K821661 - FLEXIFLO-II K821661 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1982. https://www.510kdatabase.net/k821688/ 1982-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k821688-titan-gel-high-resolution-serum-protein-fda-510k.jpg K821688 - TITAN GEL HIGH RESOLUTION SERUM PROTEIN K821688 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Jun 1982. https://www.510kdatabase.net/k821698/ 1982-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k821698-tdx-netilmicin-fda-510k.jpg K821698 - TDX NETILMICIN K821698 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1982. https://www.510kdatabase.net/k821563/ 1982-06-21 monthly 0.5 https://www.510kdatabase.net/og-image/k821563-argyle-vac-u-care-100cc-suction-reserv-fda-510k.jpg K821563 - ARGYLE VAC-U-CARE 100CC SUCTION RESERV K821563 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sherwood Medical Co.. Cleared Jun 1982. https://www.510kdatabase.net/k812262/ 1982-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k812262-medtronic-a-v-pacing-system-analyzer-fda-510k.jpg K812262 - MEDTRONIC A-V PACING SYSTEM ANALYZER K812262 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jun 1982. https://www.510kdatabase.net/k821384/ 1982-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k821384-exercise-ecg-electrodes-reusable-fda-510k.jpg K821384 - EXERCISE ECG ELECTRODES, REUSABLE K821384 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Respironics, Inc.. Cleared Jun 1982. https://www.510kdatabase.net/k821442/ 1982-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k821442-william-harvey-flex-venous-reservoir-fda-510k.jpg K821442 - WILLIAM HARVEY FLEX. VENOUS RESERVOIR K821442 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jun 1982. https://www.510kdatabase.net/k821261/ 1982-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k821261-puig-massana-shiley-annuloplasty-ring-fda-510k.jpg K821261 - PUIG MASSANA-SHILEY ANNULOPLASTY RING K821261 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Jun 1982. https://www.510kdatabase.net/k821531/ 1982-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k821531-emit-timer-unit-100-fda-510k.jpg K821531 - EMIT TIMER UNIT #100 K821531 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Jun 1982. https://www.510kdatabase.net/k821562/ 1982-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k821562-lancer-msa-bun-diag-kit-fda-510k.jpg K821562 - LANCER MSA BUN DIAG. KIT K821562 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sherwood Medical Co.. Cleared Jun 1982. https://www.510kdatabase.net/k821631/ 1982-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k821631-pinch-gauge-0-301-lbs-fda-510k.jpg K821631 - PINCH GAUGE, 0-301 LBS. K821631 is a FDA 510(k) cleared neurology medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jun 1982. https://www.510kdatabase.net/k821633/ 1982-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k821633-variable-speed-vibrator-120v-83-117-vib-fda-510k.jpg K821633 - VARIABLE SPEED VIBRATOR, 120V 83-117 VIB K821633 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jun 1982. https://www.510kdatabase.net/k821634/ 1982-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k821634-ez-stand-mobile-stool-fda-510k.jpg K821634 - EZ STAND MOBILE STOOL K821634 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jun 1982. https://www.510kdatabase.net/k821635/ 1982-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k821635-soft-ulnar-deviation-splints-fda-510k.jpg K821635 - SOFT ULNAR DEVIATION SPLINTS K821635 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jun 1982. https://www.510kdatabase.net/k821636/ 1982-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k821636-attach-a-pak-fda-510k.jpg K821636 - ATTACH-A-PAK K821636 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jun 1982. https://www.510kdatabase.net/k821637/ 1982-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k821637-wire-foam-mp-flexion-spring-fda-510k.jpg K821637 - WIRE-FOAM MP FLEXION SPRING K821637 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jun 1982. https://www.510kdatabase.net/k821638/ 1982-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k821638-hygiene-adaptors-fda-510k.jpg K821638 - HYGIENE ADAPTORS K821638 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jun 1982. https://www.510kdatabase.net/k821639/ 1982-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k821639-ankle-foot-orthosis-fda-510k.jpg K821639 - ANKLE FOOT ORTHOSIS K821639 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jun 1982. https://www.510kdatabase.net/k821640/ 1982-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k821640-orthotic-fabrication-accessories-fda-510k.jpg K821640 - ORTHOTIC FABRICATION ACCESSORIES K821640 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jun 1982. https://www.510kdatabase.net/k821641/ 1982-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k821641-obthoses-fda-510k.jpg K821641 - OBTHOSES K821641 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jun 1982. https://www.510kdatabase.net/k821642/ 1982-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k821642-wheel-chair-accessories-fda-510k.jpg K821642 - WHEEL CHAIR ACCESSORIES K821642 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jun 1982. https://www.510kdatabase.net/k821643/ 1982-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k821643-eating-utensils-fda-510k.jpg K821643 - EATING UTENSILS K821643 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jun 1982. https://www.510kdatabase.net/k821644/ 1982-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k821644-vacuum-wand-and-uni-reader-fda-510k.jpg K821644 - VACUUM WAND AND UNI-READER K821644 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jun 1982. https://www.510kdatabase.net/k821645/ 1982-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k821645-back-skpports-fda-510k.jpg K821645 - BACK SKPPORTS K821645 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jun 1982. https://www.510kdatabase.net/k821646/ 1982-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k821646-tiny-flex-glass-set-of-4-fda-510k.jpg K821646 - TINY FLEX-GLASS, SET OF 4 K821646 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jun 1982. https://www.510kdatabase.net/k821647/ 1982-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k821647-foam-wedges-fda-510k.jpg K821647 - FOAM WEDGES K821647 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jun 1982. https://www.510kdatabase.net/k821069/ 1982-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k821069-model-as6m-infusion-pump-fda-510k.jpg K821069 - MODEL AS6M INFUSION PUMP K821069 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jun 1982. https://www.510kdatabase.net/k821483/ 1982-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k821483-il-1302-ph-blood-gas-analyzer-fda-510k.jpg K821483 - IL 1302 PH BLOOD GAS ANALYZER K821483 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jun 1982. https://www.510kdatabase.net/k821517/ 1982-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k821517-titanan-gel-serum-protein-electrophores-fda-510k.jpg K821517 - TITANAN GEL SERUM PROTEIN ELECTROPHORES K821517 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Jun 1982. https://www.510kdatabase.net/k821574/ 1982-06-10 monthly 0.5 https://www.510kdatabase.net/og-image/k821574-eosin-y-solutin-agueous-fda-510k.jpg K821574 - EOSIN Y SOLUTIN, AGUEOUS K821574 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Jun 1982. https://www.510kdatabase.net/k821489/ 1982-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k821489-cordia-tg-fda-510k.jpg K821489 - CORDIA TG K821489 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Cordis Corp.. Cleared Jun 1982. https://www.510kdatabase.net/k821515/ 1982-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k821515-vented-nitroglycerin-iv-set-fda-510k.jpg K821515 - VENTED NITROGLYCERIN I.V. SET K821515 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1982. https://www.510kdatabase.net/k821573/ 1982-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k821573-eosin-y-solution-alcholic-fda-510k.jpg K821573 - EOSIN Y SOLUTION ALCHOLIC K821573 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Jun 1982. https://www.510kdatabase.net/k820218/ 1982-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k820218-pre-sterilization-of-vitallium-alloy-fda-510k.jpg K820218 - PRE-STERILIZATION OF VITALLIUM ALLOY K820218 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jun 1982. https://www.510kdatabase.net/k821566/ 1982-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k821566-orthopedic-fixation-devices-fda-510k.jpg K821566 - ORTHOPEDIC FIXATION DEVICES K821566 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jun 1982. https://www.510kdatabase.net/k820470/ 1982-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k820470-uniflex-fda-510k.jpg K820470 - UNIFLEX K820470 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Howmedica Corp.. Cleared Jun 1982. https://www.510kdatabase.net/k821320/ 1982-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k821320-hematoxylin-stain-fda-510k.jpg K821320 - HEMATOXYLIN STAIN K821320 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Jun 1982. https://www.510kdatabase.net/k821380/ 1982-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k821380-emit-tox-acetaminophen-control-fda-510k.jpg K821380 - EMIT TOX ACETAMINOPHEN CONTROL K821380 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jun 1982. https://www.510kdatabase.net/k821433/ 1982-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k821433-beckman-liquid-stat-ast-uv-liquid-fda-510k.jpg K821433 - BECKMAN LIQUID-STAT AST-UV LIQUID K821433 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jun 1982. https://www.510kdatabase.net/k821266/ 1982-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k821266-bbl-directigen-meningitis-test-kit-fda-510k.jpg K821266 - BBL DIRECTIGEN MENINGITIS TEST KIT K821266 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jun 1982. https://www.510kdatabase.net/k820837/ 1982-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k820837-disposable-multiple-ligating-clip-fda-510k.jpg K820837 - DISPOSABLE MULTIPLE LIGATING CLIP K820837 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared May 1982. https://www.510kdatabase.net/k821346/ 1982-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k821346-quantimune-hlh-ria-fda-510k.jpg K821346 - QUANTIMUNE HLH RIA K821346 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared May 1982. https://www.510kdatabase.net/k821379/ 1982-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k821379-emit-tox-acetaminophen-assay-fda-510k.jpg K821379 - EMIT-TOX ACETAMINOPHEN ASSAY K821379 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared May 1982. https://www.510kdatabase.net/k821399/ 1982-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k821399-macro-vue-card-test-netilmicin-fda-510k.jpg K821399 - MACRO-VUE CARD TEST, NETILMICIN K821399 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared May 1982. https://www.510kdatabase.net/k821413/ 1982-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k821413-emit-c-reactive-protein-assay-fda-510k.jpg K821413 - EMIT C-REACTIVE PROTEIN ASSAY K821413 is a FDA 510(k) cleared immunology medical device. Manufacturer: Syva Co.. Cleared May 1982. https://www.510kdatabase.net/k820002/ 1982-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k820002-bard-contour-link-ski-knee-sys-fda-510k.jpg K820002 - BARD CONTOUR LINK S.K.I. KNEE SYS K820002 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 1982. https://www.510kdatabase.net/k821004/ 1982-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k821004-medtronic-s3-tm-system-fda-510k.jpg K821004 - MEDTRONIC S3 TM SYSTEM K821004 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared May 1982. https://www.510kdatabase.net/k821368/ 1982-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k821368-models-78504a-78508a-patient-mon-sys-fda-510k.jpg K821368 - MODELS 78504A & 78508A PATIENT MON. SYS K821368 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared May 1982. https://www.510kdatabase.net/k821438/ 1982-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k821438-red-dot-monitoring-electrodes-226065-fda-510k.jpg K821438 - RED DOT MONITORING ELECTRODES #2260/65 K821438 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: 3M Company. Cleared May 1982. https://www.510kdatabase.net/k821305/ 1982-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k821305-prolactin-125-i-radioimmunoassay-kit-fda-510k.jpg K821305 - PROLACTIN (125-I) RADIOIMMUNOASSAY KIT K821305 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared May 1982. https://www.510kdatabase.net/k821397/ 1982-05-24 monthly 0.5 https://www.510kdatabase.net/og-image/k821397-adult-incontinet-brief-fda-510k.jpg K821397 - ADULT INCONTINET BRIEF K821397 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared May 1982. https://www.510kdatabase.net/k820909/ 1982-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k820909-gore-tex-peritoneal-catheterr-fda-510k.jpg K820909 - GORE-TEX PERITONEAL CATHETERR K820909 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared May 1982. https://www.510kdatabase.net/k821023/ 1982-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k821023-thoracic-drainage-system-fda-510k.jpg K821023 - THORACIC DRAINAGE SYSTEM K821023 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Howmedica Corp.. Cleared May 1982. https://www.510kdatabase.net/k821180/ 1982-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k821180-tracelon-fda-510k.jpg K821180 - TRACELON K821180 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Terumo Medical Corp.. Cleared May 1982. https://www.510kdatabase.net/k821240/ 1982-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k821240-liquid-stat-liquid-enzyme-reagent-fda-510k.jpg K821240 - LIQUID-STAT LIQUID ENZYME REAGENT K821240 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared May 1982. https://www.510kdatabase.net/k821242/ 1982-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k821242-response-liquid-ligand-assay-serum-fda-510k.jpg K821242 - RESPONSE LIQUID LIGAND ASSAY SERUM K821242 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared May 1982. https://www.510kdatabase.net/k821247/ 1982-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k821247-accudex-reagent-strips-fda-510k.jpg K821247 - ACCUDEX REAGENT STRIPS K821247 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared May 1982. https://www.510kdatabase.net/k821369/ 1982-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k821369-titanium-aufranc-turner-ats-hip-sys-fda-510k.jpg K821369 - TITANIUM AUFRANC-TURNER ATS HIP SYS K821369 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared May 1982. https://www.510kdatabase.net/k821158/ 1982-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k821158-fed-ringed-tex-vascular-graft-fda-510k.jpg K821158 - FED RINGED-TEX VASCULAR GRAFT K821158 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared May 1982. https://www.510kdatabase.net/k820296/ 1982-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k820296-stratus-tdm-control-levels-iiiiii-fda-510k.jpg K820296 - STRATUS TDM CONTROL, LEVELS I,II,III K820296 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared May 1982. https://www.510kdatabase.net/k820888/ 1982-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k820888-8700-clinical-chem-analyzer-fda-510k.jpg K820888 - 8700 CLINICAL CHEM. ANALYZER K820888 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared May 1982. https://www.510kdatabase.net/k820905/ 1982-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k820905-beckman-mmc-ii-metabolic-meas-cart-fda-510k.jpg K820905 - BECKMAN MMC II METABOLIC MEAS. CART K820905 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared May 1982. https://www.510kdatabase.net/k821024/ 1982-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k821024-disp-skin-stapler-removalble-skinstaple-fda-510k.jpg K821024 - DISP. SKIN STAPLER REMOVALBLE SKINSTAPLE K821024 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Howmedica Corp.. Cleared May 1982. https://www.510kdatabase.net/k821175/ 1982-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k821175-gastrin-radioimmunoassay-kit-125-i-fda-510k.jpg K821175 - GASTRIN RADIOIMMUNOASSAY KIT (125-I) K821175 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared May 1982. https://www.510kdatabase.net/k821179/ 1982-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k821179-visidex-reagent-strips-fda-510k.jpg K821179 - VISIDEX REAGENT STRIPS K821179 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared May 1982. https://www.510kdatabase.net/k821228/ 1982-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k821228-deknatel-skin-staple-extractor-fda-510k.jpg K821228 - DEKNATEL SKIN STAPLE EXTRACTOR K821228 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Howmedica Corp.. Cleared May 1982. https://www.510kdatabase.net/k821244/ 1982-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k821244-disposable-temperature-probe-fda-510k.jpg K821244 - DISPOSABLE TEMPERATURE PROBE K821244 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shiley, Inc.. Cleared May 1982. https://www.510kdatabase.net/k821136/ 1982-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k821136-tdx-tm-streptomycin-fda-510k.jpg K821136 - TDX TM STREPTOMYCIN K821136 is a FDA 510(k) cleared hematology medical device. Manufacturer: Abbott Laboratories. Cleared May 1982. https://www.510kdatabase.net/k820772/ 1982-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k820772-fetal-tek-control-immatureborderline-fda-510k.jpg K820772 - FETAL-TEK CONTROL (IMMATURE/BORDERLINE) K820772 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared May 1982. https://www.510kdatabase.net/k821514/ 1982-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k821514-technicon-ra-1000-sys-analytes-iii-fda-510k.jpg K821514 - TECHNICON RA-1000 SYS, ANALYTES III K821514 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared May 1982. https://www.510kdatabase.net/k820594/ 1982-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k820594-biostrip-g-fda-510k.jpg K820594 - BIOSTRIP G K820594 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared May 1982. https://www.510kdatabase.net/k820913/ 1982-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k820913-ra-1000-system-addl-analytes-phase-iii-fda-510k.jpg K820913 - RA-1000 SYSTEM ADD'L ANALYTES PHASE III K820913 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared May 1982. https://www.510kdatabase.net/k821027/ 1982-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k821027-soft-tip-low-pressure-cuffed-oralnasal-fda-510k.jpg K821027 - SOFT TIP LOW PRESSURE CUFFED ORAL/NASAL K821027 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shiley, Inc.. Cleared May 1982. https://www.510kdatabase.net/k821048/ 1982-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k821048-liquid-stat-tm-ast-uv-liquid-enzune-fda-510k.jpg K821048 - LIQUID-STAT TM AST-UV LIQUID ENZUNE K821048 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared May 1982. https://www.510kdatabase.net/k821061/ 1982-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k821061-ace-albumin-calibrator-fda-510k.jpg K821061 - ACE ALBUMIN CALIBRATOR K821061 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared May 1982. https://www.510kdatabase.net/k821064/ 1982-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k821064-inspiron-neonatal-ventilator-circuit-fda-510k.jpg K821064 - INSPIRON NEONATAL VENTILATOR CIRCUIT K821064 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 1982. https://www.510kdatabase.net/k820438/ 1982-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k820438-quinton-q2000-ett-monitoring-system-fda-510k.jpg K820438 - QUINTON Q2000 ETT MONITORING SYSTEM K820438 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Apr 1982. https://www.510kdatabase.net/k821029/ 1982-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k821029-arthroscopy-system-leg-holder-fda-510k.jpg K821029 - ARTHROSCOPY SYSTEM LEG HOLDER K821029 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Zimmer, Inc.. Cleared Apr 1982. https://www.510kdatabase.net/k821062/ 1982-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k821062-hematoxylin-solution-fda-510k.jpg K821062 - HEMATOXYLIN SOLUTION K821062 is a FDA 510(k) cleared pathology medical device. Manufacturer: Sigma Chemical Co.. Cleared Apr 1982. https://www.510kdatabase.net/k821066/ 1982-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k821066-contour-ii-link-sp-total-hip-prosthesis-fda-510k.jpg K821066 - CONTOUR II LINK SP TOTAL HIP PROSTHESIS K821066 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 1982. https://www.510kdatabase.net/k827345/ 1982-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k827345-vhr-video-system-fda-510k.jpg K827345 - VHR VIDEO SYSTEM K827345 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Apr 1982. https://www.510kdatabase.net/k820900/ 1982-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k820900-emit-urine-methadone-assay-3e319-fda-510k.jpg K820900 - EMIT URINE METHADONE ASSAY #3E319 K820900 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Apr 1982. https://www.510kdatabase.net/k820702/ 1982-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k820702-il-7f-flow-director-thermal-dilu-cath-fda-510k.jpg K820702 - IL 7F FLOW DIRECTOR THERMAL DILU. CATH K820702 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Apr 1982. https://www.510kdatabase.net/k820860/ 1982-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k820860-volumetric-pump-cassette-wattached-set-fda-510k.jpg K820860 - VOLUMETRIC PUMP CASSETTE W/ATTACHED SET K820860 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Apr 1982. https://www.510kdatabase.net/k820876/ 1982-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k820876-model-3854-electrode-fda-510k.jpg K820876 - MODEL 3854 ELECTRODE K820876 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Apr 1982. https://www.510kdatabase.net/k827288/ 1982-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k827288-mlx-lateral-imaging-system-fda-510k.jpg K827288 - MLX LATERAL IMAGING SYSTEM K827288 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Apr 1982. https://www.510kdatabase.net/k820487/ 1982-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k820487-implantible-suture-sleeve-fda-510k.jpg K820487 - IMPLANTIBLE SUTURE SLEEVE K820487 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Apr 1982. https://www.510kdatabase.net/k820859/ 1982-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k820859-coaxial-dual-flow-catheter-fda-510k.jpg K820859 - COAXIAL DUAL FLOW CATHETER K820859 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Terumo Medical Corp.. Cleared Apr 1982. https://www.510kdatabase.net/k820880/ 1982-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k820880-seralyzer-ck-reagent-strips-fda-510k.jpg K820880 - SERALYZER CK REAGENT STRIPS K820880 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Apr 1982. https://www.510kdatabase.net/k820935/ 1982-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k820935-model-5866-26-lead-adapter-kit-fda-510k.jpg K820935 - MODEL 5866-26 LEAD ADAPTER KIT K820935 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Apr 1982. https://www.510kdatabase.net/k820477/ 1982-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k820477-algorithm-of-the-arrhythmia-mon-sys-fda-510k.jpg K820477 - ALGORITHM OF THE ARRHYTHMIA MON. SYS K820477 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Apr 1982. https://www.510kdatabase.net/k820742/ 1982-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k820742-nihon-kohden-blood-flowmeters-mfv-1100-fda-510k.jpg K820742 - NIHON KOHDEN BLOOD FLOWMETERS #MFV-1100 K820742 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Apr 1982. https://www.510kdatabase.net/k820744/ 1982-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k820744-il-model-1301-ph-blood-gas-system-fda-510k.jpg K820744 - IL MODEL 1301, PH BLOOD GAS SYSTEM K820744 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Apr 1982. https://www.510kdatabase.net/k820747/ 1982-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k820747-monoject-saf-t-lock-fda-510k.jpg K820747 - MONOJECT SAF-T-LOCK K820747 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Apr 1982. https://www.510kdatabase.net/k820825/ 1982-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k820825-cardiac-monitor-rate-alarm-fda-510k.jpg K820825 - CARDIAC MONITOR - RATE ALARM K820825 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Apr 1982. https://www.510kdatabase.net/k820368/ 1982-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k820368-lectin-a-fda-510k.jpg K820368 - LECTIN-A K820368 is a FDA 510(k) cleared hematology medical device. Manufacturer: American Dade. Cleared Apr 1982. https://www.510kdatabase.net/k820716/ 1982-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k820716-monoject-512-syringes-wwo-needles-fda-510k.jpg K820716 - MONOJECT 512 SYRINGES W/WO NEEDLES K820716 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Apr 1982. https://www.510kdatabase.net/k820718/ 1982-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k820718-argyle-thoracic-catheters-fda-510k.jpg K820718 - ARGYLE THORACIC CATHETERS K820718 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Apr 1982. https://www.510kdatabase.net/k820834/ 1982-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k820834-percor-percutaneous-introducer-fda-510k.jpg K820834 - PERCOR PERCUTANEOUS INTRODUCER K820834 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Apr 1982. https://www.510kdatabase.net/k813033/ 1982-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k813033-clay-adams-qbc-centrifugal-hemotology-fda-510k.jpg K813033 - CLAY ADAMS QBC CENTRIFUGAL HEMOTOLOGY K813033 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1982. https://www.510kdatabase.net/k820572/ 1982-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k820572-argyle-delee-suction-catheter-wmucous-fda-510k.jpg K820572 - ARGYLE DELEE SUCTION CATHETER W/MUCOUS K820572 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Sherwood Medical Co.. Cleared Apr 1982. https://www.510kdatabase.net/k820781/ 1982-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k820781-coat-a-count-amikacin-ira-fda-510k.jpg K820781 - COAT-A-COUNT AMIKACIN IRA K820781 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Apr 1982. https://www.510kdatabase.net/k820853/ 1982-04-09 monthly 0.5 https://www.510kdatabase.net/og-image/k820853-quantum-models-253-09-254-09-254-10-fda-510k.jpg K820853 - QUANTUM MODELS 253-09, 254-09 254-10 K820853 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Apr 1982. https://www.510kdatabase.net/k820773/ 1982-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k820773-emit-st-urine-cocaine-metabolite-assay-fda-510k.jpg K820773 - EMIT-ST URINE COCAINE METABOLITE ASSAY K820773 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Apr 1982. https://www.510kdatabase.net/k820787/ 1982-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k820787-helena-abnormal-hba2-quik-column-control-fda-510k.jpg K820787 - HELENA ABNORMAL HBA2 QUIK COLUMN CONTROL K820787 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Apr 1982. https://www.510kdatabase.net/k820728/ 1982-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k820728-quantimune-estriol-ria-fda-510k.jpg K820728 - QUANTIMUNE ESTRIOL RIA K820728 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Apr 1982. https://www.510kdatabase.net/k820788/ 1982-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k820788-clirans-priming-set-fda-510k.jpg K820788 - CLIRANS PRIMING SET K820788 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terumo Medical Corp.. Cleared Apr 1982. https://www.510kdatabase.net/k820573/ 1982-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k820573-helena-hemoglobin-detect-column-sys-fda-510k.jpg K820573 - HELENA HEMOGLOBIN DETECT COLUMN SYS K820573 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Apr 1982. https://www.510kdatabase.net/k820687/ 1982-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k820687-dupont-automatic-clinical-analyzer-fda-510k.jpg K820687 - DUPONT AUTOMATIC CLINICAL ANALYZER K820687 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Apr 1982. https://www.510kdatabase.net/k820698/ 1982-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k820698-syva-advance-standardization-kit-01-fda-510k.jpg K820698 - SYVA ADVANCE STANDARDIZATION KIT 01 K820698 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Apr 1982. https://www.510kdatabase.net/k820717/ 1982-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k820717-monoject-corvac-stat-vac-tube-wthrom-fda-510k.jpg K820717 - MONOJECT CORVAC STAT VAC TUBE W/THROM K820717 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sherwood Medical Co.. Cleared Apr 1982. https://www.510kdatabase.net/k820722/ 1982-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k820722-kodak-ektachem-clinical-chemistry-slidde-fda-510k.jpg K820722 - KODAK EKTACHEM CLINICAL CHEMISTRY SLIDDE K820722 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Apr 1982. https://www.510kdatabase.net/k820723/ 1982-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k820723-kodak-ektachem-clinical-chem-nh3-fda-510k.jpg K820723 - KODAK EKTACHEM CLINICAL CHEM. NH3 K820723 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Apr 1982. https://www.510kdatabase.net/k813182/ 1982-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k813182-datascope-modified-82-iabp-system-fda-510k.jpg K813182 - DATASCOPE MODIFIED #82 IABP SYSTEM K813182 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Mar 1982. https://www.510kdatabase.net/k820612/ 1982-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k820612-tensoplast-skin-traction-kit-fda-510k.jpg K820612 - TENSOPLAST SKIN TRACTION KIT K820612 is a FDA 510(k) cleared neurology medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Mar 1982. https://www.510kdatabase.net/k820688/ 1982-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k820688-arrange-tm-fda-510k.jpg K820688 - ARRANGE TM K820688 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Mar 1982. https://www.510kdatabase.net/k820193/ 1982-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k820193-gore-tex-tissue-reinforcement-patch-fda-510k.jpg K820193 - GORE-TEX TISSUE REINFORCEMENT PATCH K820193 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Mar 1982. https://www.510kdatabase.net/k820268/ 1982-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k820268-adaptaid-temp-pacing-ext-lead-366-02-fda-510k.jpg K820268 - ADAPTAID TEMP. PACING EXT. LEAD #366-02 K820268 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Mar 1982. https://www.510kdatabase.net/k820437/ 1982-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k820437-aves-wright-stain-fda-510k.jpg K820437 - AVES WRIGHT STAIN K820437 is a FDA 510(k) cleared pathology medical device. Manufacturer: Helena Laboratories. Cleared Mar 1982. https://www.510kdatabase.net/k820596/ 1982-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k820596-cyanmethemoglobin-test-fda-510k.jpg K820596 - CYANMETHEMOGLOBIN TEST K820596 is a FDA 510(k) cleared hematology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Mar 1982. https://www.510kdatabase.net/k820319/ 1982-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k820319-fetal-tek-control-mature-fda-510k.jpg K820319 - FETAL-TEK CONTROL MATURE K820319 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Mar 1982. https://www.510kdatabase.net/k813581/ 1982-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k813581-cruciate-ligament-button-fda-510k.jpg K813581 - CRUCIATE LIGAMENT BUTTON K813581 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Biomet, Inc.. Cleared Mar 1982. https://www.510kdatabase.net/k820215/ 1982-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k820215-improved-dycal-fda-510k.jpg K820215 - IMPROVED DYCAL K820215 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Mar 1982. https://www.510kdatabase.net/k820284/ 1982-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k820284-root-canal-filling-resin-fda-510k.jpg K820284 - ROOT CANAL FILLING RESIN K820284 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Mar 1982. https://www.510kdatabase.net/k820530/ 1982-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k820530-t-iv-elite-alloy-fda-510k.jpg K820530 - T-IV ELITE ALLOY K820530 is a FDA 510(k) cleared dental medical device. Manufacturer: Howmedica Corp.. Cleared Mar 1982. https://www.510kdatabase.net/k820356/ 1982-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k820356-multicor-gamma-402-cardiac-pacer-fda-510k.jpg K820356 - MULTICOR (GAMMA) 402 CARDIAC PACER K820356 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Mar 1982. https://www.510kdatabase.net/k820582/ 1982-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k820582-3m-thinsulate-disposable-hospital-bed-fda-510k.jpg K820582 - 3M THINSULATE DISPOSABLE HOSPITAL BED K820582 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Mar 1982. https://www.510kdatabase.net/k820534/ 1982-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k820534-coat-a-count-progesterone-kia-kit-fda-510k.jpg K820534 - COAT-A-COUNT PROGESTERONE KIA KIT K820534 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Mar 1982. https://www.510kdatabase.net/k820299/ 1982-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k820299-prompt-inoculation-system-fda-510k.jpg K820299 - PROMPT INOCULATION SYSTEM K820299 is a FDA 510(k) cleared microbiology medical device. Manufacturer: 3M Company. Cleared Mar 1982. https://www.510kdatabase.net/k820440/ 1982-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k820440-emit-amd-amikacin-contr-enzyme-immuno-fda-510k.jpg K820440 - EMIT-AMD AMIKACIN CONTR. (ENZYME IMMUNO K820440 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Mar 1982. https://www.510kdatabase.net/k820472/ 1982-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k820472-william-harvey-h-625-arterial-filter-fda-510k.jpg K820472 - WILLIAM HARVEY H-625 ARTERIAL FILTER K820472 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 1982. https://www.510kdatabase.net/k820539/ 1982-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k820539-relieved-reinforced-cup-fda-510k.jpg K820539 - RELIEVED REINFORCED CUP K820539 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biomet, Inc.. Cleared Mar 1982. https://www.510kdatabase.net/k820297/ 1982-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k820297-wm-harvey-overpressure-safety-valve-fda-510k.jpg K820297 - WM. HARVEY OVERPRESSURE SAFETY VALVE K820297 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 1982. https://www.510kdatabase.net/k820271/ 1982-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k820271-abbott-laboratories-b-hcg-eia-fda-510k.jpg K820271 - ABBOTT LABORATORIES B-HCG EIA K820271 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1982. https://www.510kdatabase.net/k820389/ 1982-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k820389-a-dental-amalgam-alloy-unnamed-fda-510k.jpg K820389 - A DENTAL AMALGAM ALLOY (UNNAMED K820389 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Mar 1982. https://www.510kdatabase.net/k820427/ 1982-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k820427-il-8060-data-management-system-fda-510k.jpg K820427 - IL 8060 DATA MANAGEMENT SYSTEM K820427 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Mar 1982. https://www.510kdatabase.net/k820432/ 1982-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k820432-class-of-casting-alloys-type-i-or-alter-fda-510k.jpg K820432 - CLASS OF CASTING ALLOYS TYPE I OR ALTER K820432 is a FDA 510(k) cleared dental medical device. Manufacturer: Howmedica Corp.. Cleared Mar 1982. https://www.510kdatabase.net/k820433/ 1982-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k820433-class-of-casting-alloys-type-ii-or-alter-fda-510k.jpg K820433 - CLASS OF CASTING ALLOYS TYPE II OR ALTER K820433 is a FDA 510(k) cleared dental medical device. Manufacturer: Howmedica Corp.. Cleared Mar 1982. https://www.510kdatabase.net/k820434/ 1982-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k820434-class-of-casting-alloys-type-iii-or-alt-fda-510k.jpg K820434 - CLASS OF CASTING ALLOYS TYPE III OR ALT K820434 is a FDA 510(k) cleared dental medical device. Manufacturer: Howmedica Corp.. Cleared Mar 1982. https://www.510kdatabase.net/k820439/ 1982-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k820439-emit-amd-amikacin-control-fda-510k.jpg K820439 - EMIT-AMD AMIKACIN CONTROL K820439 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Mar 1982. https://www.510kdatabase.net/k820461/ 1982-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k820461-emit-st-urine-calibrator-a-3a319-fda-510k.jpg K820461 - EMIT-ST URINE CALIBRATOR A (#3A319 K820461 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Mar 1982. https://www.510kdatabase.net/k820462/ 1982-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k820462-emit-st-urine-controls-set-a-3a349-fda-510k.jpg K820462 - EMIT-ST URINE CONTROLS SET A #3A349 K820462 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Mar 1982. https://www.510kdatabase.net/k820478/ 1982-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k820478-quinton-q55-medical-treadmill-fda-510k.jpg K820478 - QUINTON Q55 MEDICAL TREADMILL K820478 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Quinton, Inc.. Cleared Mar 1982. https://www.510kdatabase.net/k820333/ 1982-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k820333-monojector-monolet-lancer-fda-510k.jpg K820333 - MONOJECTOR MONOLET LANCER K820333 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sherwood Medical Co.. Cleared Mar 1982. https://www.510kdatabase.net/k820441/ 1982-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k820441-argyle-pvc-feeding-tube-fda-510k.jpg K820441 - ARGYLE PVC FEEDING TUBE K820441 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Sherwood Medical Co.. Cleared Mar 1982. https://www.510kdatabase.net/k820442/ 1982-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k820442-argyle-indwell-feeding-tube-fda-510k.jpg K820442 - ARGYLE INDWELL FEEDING TUBE K820442 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Sherwood Medical Co.. Cleared Mar 1982. https://www.510kdatabase.net/k820378/ 1982-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k820378-ld-l-tris-system-pack-test-fda-510k.jpg K820378 - LD-L TRIS SYSTEM PACK TEST K820378 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Mar 1982. https://www.510kdatabase.net/k820394/ 1982-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k820394-technicon-ra-1000-system-add-analyt-fda-510k.jpg K820394 - TECHNICON RA-1000 SYSTEM ADD. ANALYT K820394 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Mar 1982. https://www.510kdatabase.net/k813413/ 1982-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k813413-lectin-h-fda-510k.jpg K813413 - LECTIN H K813413 is a FDA 510(k) cleared pathology medical device. Manufacturer: American Dade. Cleared Mar 1982. https://www.510kdatabase.net/k820416/ 1982-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k820416-505-port-vital-functions-neonatal-mon-fda-510k.jpg K820416 - #505 PORT. VITAL FUNCTIONS NEONATAL MON K820416 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Mar 1982. https://www.510kdatabase.net/k820417/ 1982-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k820417-506-port-vital-functions-neonatal-mon-fda-510k.jpg K820417 - #506 PORT. VITAL FUNCTIONS NEONATAL MON K820417 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Mar 1982. https://www.510kdatabase.net/k812802/ 1982-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k812802-capd-uv-germicidal-connection-system-fda-510k.jpg K812802 - CAPD U.V. GERMICIDAL CONNECTION SYSTEM K812802 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Mar 1982. https://www.510kdatabase.net/k820244/ 1982-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k820244-addl-terminal-support-for-star-basic-fda-510k.jpg K820244 - ADD'L TERMINAL SUPPORT FOR STAR BASIC K820244 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Mar 1982. https://www.510kdatabase.net/k820258/ 1982-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k820258-deknatel-disposable-goosen-vascular-pnch-fda-510k.jpg K820258 - DEKNATEL DISPOSABLE GOOSEN VASCULAR PNCH K820258 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Howmedica Corp.. Cleared Mar 1982. https://www.510kdatabase.net/k820328/ 1982-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k820328-nickel-based-dental-casting-alloy-fda-510k.jpg K820328 - NICKEL-BASED DENTAL CASTING ALLOY K820328 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Mar 1982. https://www.510kdatabase.net/k820406/ 1982-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k820406-tmo-integrated-circuit-system-fda-510k.jpg K820406 - TMO INTEGRATED CIRCUIT SYSTEM K820406 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Mar 1982. https://www.510kdatabase.net/k820407/ 1982-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k820407-class-of-precious-metal-casting-alloys-fda-510k.jpg K820407 - CLASS OF PRECIOUS METAL CASTING ALLOYS K820407 is a FDA 510(k) cleared dental medical device. Manufacturer: Howmedica Corp.. Cleared Mar 1982. https://www.510kdatabase.net/k820408/ 1982-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k820408-class-of-casting-alloys-type-iv-or-alt-fda-510k.jpg K820408 - CLASS OF CASTING ALLOYS TYPE IV OR ALT K820408 is a FDA 510(k) cleared dental medical device. Manufacturer: Howmedica Corp.. Cleared Mar 1982. https://www.510kdatabase.net/k827104/ 1982-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k827104-additional-terminal-support-for-star-fda-510k.jpg K827104 - ADDITIONAL TERMINAL SUPPORT FOR STAR TM BASIC SYSTEM K827104 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Mar 1982. https://www.510kdatabase.net/k813002/ 1982-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k813002-mavis-c-fda-510k.jpg K813002 - MAVIS C K813002 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Mar 1982. https://www.510kdatabase.net/k813371/ 1982-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k813371-grosse-and-kempf-locking-nail-sys-fda-510k.jpg K813371 - GROSSE AND KEMPF LOCKING NAIL SYS. K813371 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Mar 1982. https://www.510kdatabase.net/k813328/ 1982-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k813328-myersonkenson-gp-polymer-fda-510k.jpg K813328 - MYERSON/KENSON GP POLYMER K813328 is a FDA 510(k) cleared dental medical device. Manufacturer: Howmedica Corp.. Cleared Feb 1982. https://www.510kdatabase.net/k813550/ 1982-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k813550-hybrid-dental-product-fda-510k.jpg K813550 - HYBRID DENTAL PRODUCT K813550 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Feb 1982. https://www.510kdatabase.net/k820184/ 1982-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k820184-lateral-angulating-fluoro-suspension-fda-510k.jpg K820184 - LATERAL ANGULATING FLUORO SUSPENSION K820184 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Feb 1982. https://www.510kdatabase.net/k827064/ 1982-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k827064-siemens-polydoros-800-fda-510k.jpg K827064 - SIEMENS POLYDOROS 800 K827064 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 1982. https://www.510kdatabase.net/k827086/ 1982-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k827086-lateral-angulating-fluoro-suspension-fda-510k.jpg K827086 - LATERAL ANGULATING FLUORO SUSPENSION K827086 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Feb 1982. https://www.510kdatabase.net/k820085/ 1982-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k820085-dade-factor-assay-reference-plasma-fda-510k.jpg K820085 - DADE FACTOR ASSAY REFERENCE PLASMA K820085 is a FDA 510(k) cleared hematology medical device. Manufacturer: American Dade. Cleared Feb 1982. https://www.510kdatabase.net/k820104/ 1982-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k820104-nupro-gel-tray-fda-510k.jpg K820104 - NUPRO* GEL TRAY K820104 is a FDA 510(k) cleared dental medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Feb 1982. https://www.510kdatabase.net/k820224/ 1982-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k820224-emit-freelevel-system-i-fda-510k.jpg K820224 - EMIT FREELEVEL SYSTEM I K820224 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Feb 1982. https://www.510kdatabase.net/k820286/ 1982-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k820286-syva-advance-sy-emit-amd-gent-control-fda-510k.jpg K820286 - SYVA ADVANCE SY. EMIT-AMD GENT. CONTROL K820286 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Feb 1982. https://www.510kdatabase.net/k820323/ 1982-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k820323-emit-and-netilmicin-control-fda-510k.jpg K820323 - EMIT AND NETILMICIN CONTROL K820323 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Feb 1982. https://www.510kdatabase.net/k820324/ 1982-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k820324-emit-and-netilmicin-assay-fda-510k.jpg K820324 - EMIT AND NETILMICIN ASSAY K820324 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Feb 1982. https://www.510kdatabase.net/k813530/ 1982-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k813530-hemotology-calibrator-fda-510k.jpg K813530 - HEMOTOLOGY CALIBRATOR K813530 is a FDA 510(k) cleared hematology medical device. Manufacturer: American Dade. Cleared Feb 1982. https://www.510kdatabase.net/k820084/ 1982-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k820084-clotting-time-reagent-fda-510k.jpg K820084 - CLOTTING TIME REAGENT K820084 is a FDA 510(k) cleared hematology medical device. Manufacturer: American Dade. Cleared Feb 1982. https://www.510kdatabase.net/k820263/ 1982-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k820263-kodak-ektachem-clinical-chemistry-slides-fda-510k.jpg K820263 - KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES K820263 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Feb 1982. https://www.510kdatabase.net/k820285/ 1982-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k820285-syva-advance-syst-emit-amd-gent-assay-fda-510k.jpg K820285 - SYVA ADVANCE SYST. EMIT-AMD GENT. ASSAY K820285 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Feb 1982. https://www.510kdatabase.net/k827065/ 1982-02-18 monthly 0.5 https://www.510kdatabase.net/og-image/k827065-siemens-sireskop-4-fda-510k.jpg K827065 - SIEMENS SIRESKOP 4 K827065 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared Feb 1982. https://www.510kdatabase.net/k813463/ 1982-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k813463-sil-v-ur-chest-catheter-fda-510k.jpg K813463 - SIL-V-UR CHEST CATHETER K813463 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Feb 1982. https://www.510kdatabase.net/k820067/ 1982-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k820067-electroencephalograph-ecg-6151-fda-510k.jpg K820067 - ELECTROENCEPHALOGRAPH ECG-6151 K820067 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Feb 1982. https://www.510kdatabase.net/k820186/ 1982-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k820186-bard-cardiopulmonary-monitoring-lines-fda-510k.jpg K820186 - BARD CARDIOPULMONARY MONITORING LINES K820186 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Feb 1982. https://www.510kdatabase.net/k820187/ 1982-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k820187-syva-advance-sys-emitr-aedr-pheny-fda-510k.jpg K820187 - SYVA ADVANCE SYS. EMIT,(R)-AED(R) PHENY K820187 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Feb 1982. https://www.510kdatabase.net/k820189/ 1982-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k820189-carbamazepine-assay-fda-510k.jpg K820189 - CARBAMAZEPINE ASSAY K820189 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Feb 1982. https://www.510kdatabase.net/k820190/ 1982-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k820190-calibrator-set-fda-510k.jpg K820190 - CALIBRATOR SET K820190 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Feb 1982. https://www.510kdatabase.net/k820191/ 1982-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k820191-control-set-fda-510k.jpg K820191 - CONTROL SET K820191 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Feb 1982. https://www.510kdatabase.net/k820282/ 1982-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k820282-ace-brand-instant-cold-pack-fda-510k.jpg K820282 - ACE BRAND INSTANT COLD PACK K820282 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Feb 1982. https://www.510kdatabase.net/k820030/ 1982-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k820030-howmedica-kinematic-total-condylar-knee-fda-510k.jpg K820030 - HOWMEDICA KINEMATIC TOTAL CONDYLAR KNEE K820030 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Feb 1982. https://www.510kdatabase.net/k820130/ 1982-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k820130-advance-system-emit-amd-tobramycin-assay-fda-510k.jpg K820130 - ADVANCE SYSTEM EMIT-AMD TOBRAMYCIN ASSAY K820130 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Feb 1982. https://www.510kdatabase.net/k820134/ 1982-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k820134-vigilon-primary-wound-dressing-sterile-fda-510k.jpg K820134 - VIGILON PRIMARY WOUND DRESSING, STERILE K820134 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Feb 1982. https://www.510kdatabase.net/k820154/ 1982-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k820154-tdx-digoxin-fda-510k.jpg K820154 - TDX DIGOXIN K820154 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Feb 1982. https://www.510kdatabase.net/k820188/ 1982-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k820188-phenobarbital-assay-fda-510k.jpg K820188 - PHENOBARBITAL ASSAY K820188 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Feb 1982. https://www.510kdatabase.net/k813052/ 1982-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k813052-ultracast-waterless-synthetic-resin-cast-fda-510k.jpg K813052 - ULTRACAST WATERLESS SYNTHETIC RESIN CAST K813052 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zimmer, Inc.. Cleared Feb 1982. https://www.510kdatabase.net/k820066/ 1982-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k820066-electroencephalographs-eeg-52085210-fda-510k.jpg K820066 - ELECTROENCEPHALOGRAPHS EEG-5208,5210 K820066 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Feb 1982. https://www.510kdatabase.net/k820087/ 1982-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k820087-codman-reusable-perforator-fda-510k.jpg K820087 - CODMAN * REUSABLE PERFORATOR K820087 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Feb 1982. https://www.510kdatabase.net/k820118/ 1982-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k820118-electrolyte-analyzer-accessory-fda-510k.jpg K820118 - ELECTROLYTE ANALYZER ACCESSORY K820118 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Feb 1982. https://www.510kdatabase.net/k813266/ 1982-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k813266-nihon-kohden-electrocardiograph-fda-510k.jpg K813266 - NIHON KOHDEN ELECTROCARDIOGRAPH K813266 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Jan 1982. https://www.510kdatabase.net/k820109/ 1982-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k820109-radiation-sterilized-suction-catheters-fda-510k.jpg K820109 - RADIATION STERILIZED SUCTION CATHETERS K820109 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Jan 1982. https://www.510kdatabase.net/k820129/ 1982-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k820129-advance-system-emit-amd-tobramycin-cntrl-fda-510k.jpg K820129 - ADVANCE SYSTEM EMIT-AMD TOBRAMYCIN CNTRL K820129 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jan 1982. https://www.510kdatabase.net/k812435/ 1982-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k812435-datapass-fda-510k.jpg K812435 - DATAPASS K812435 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jan 1982. https://www.510kdatabase.net/k813590/ 1982-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k813590-model-as6b-infusion-pump-fda-510k.jpg K813590 - MODEL AS6B INFUSION PUMP K813590 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jan 1982. https://www.510kdatabase.net/k820043/ 1982-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k820043-tek-pro-tek-tator-v-rotator-humidify-fda-510k.jpg K820043 - TEK-PRO TEK-TATOR V ROTATOR & HUMIDIFY K820043 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Jan 1982. https://www.510kdatabase.net/k820060/ 1982-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k820060-campylobacter-thioglycollate-med-w5-fda-510k.jpg K820060 - CAMPYLOBACTER THIOGLYCOLLATE MED W/5 K820060 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jan 1982. https://www.510kdatabase.net/k820071/ 1982-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k820071-model-5790-gas-chromatograph-fda-510k.jpg K820071 - MODEL 5790 GAS CHROMATOGRAPH K820071 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Jan 1982. https://www.510kdatabase.net/k820103/ 1982-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k820103-pathway-ph-blood-gas-control-fda-510k.jpg K820103 - PATHWAY PH BLOOD GAS CONTROL K820103 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jan 1982. https://www.510kdatabase.net/k820131/ 1982-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k820131-3m-volume-ventiator-circuit-fda-510k.jpg K820131 - 3M VOLUME VENTIATOR CIRCUIT K820131 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: 3M Company. Cleared Jan 1982. https://www.510kdatabase.net/k820132/ 1982-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k820132-babybird-2-ventilator-fda-510k.jpg K820132 - BABYBIRD 2 VENTILATOR K820132 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: 3M Company. Cleared Jan 1982. https://www.510kdatabase.net/k820138/ 1982-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k820138-primidone-reagent-test-kit-fda-510k.jpg K820138 - PRIMIDONE REAGENT TEST KIT K820138 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jan 1982. https://www.510kdatabase.net/k812750/ 1982-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k812750-il-703-stat-separator-fda-510k.jpg K812750 - IL 703, STAT SEPARATOR K812750 is a FDA 510(k) cleared hematology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jan 1982. https://www.510kdatabase.net/k820075/ 1982-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k820075-seralyzer-creatinine-reagent-strips-fda-510k.jpg K820075 - SERALYZER CREATININE REAGENT STRIPS K820075 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Jan 1982. https://www.510kdatabase.net/k812678/ 1982-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k812678-tegaderm-transparent-dressing-fda-510k.jpg K812678 - TEGADERM TRANSPARENT DRESSING K812678 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3M Company. Cleared Jan 1982. https://www.510kdatabase.net/k813220/ 1982-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k813220-regu-vac-oxygenating-suction-catheter-fda-510k.jpg K813220 - REGU-VAC OXYGENATING SUCTION CATHETER K813220 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jan 1982. https://www.510kdatabase.net/k813473/ 1982-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k813473-5b-slave-module-syringe-pump-fda-510k.jpg K813473 - 5B SLAVE MODULE SYRINGE PUMP K813473 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jan 1982. https://www.510kdatabase.net/k813565/ 1982-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k813565-radiation-sterilized-surgeons-gloves-fda-510k.jpg K813565 - RADIATION STERILIZED SURGEON'S GLOVES K813565 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Jan 1982. https://www.510kdatabase.net/k813597/ 1982-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k813597-tdx-primidone-fda-510k.jpg K813597 - TDX PRIMIDONE K813597 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jan 1982. https://www.510kdatabase.net/k812925/ 1982-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k812925-abbott-pap-eia-fda-510k.jpg K812925 - ABBOTT PAP-EIA K812925 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jan 1982. https://www.510kdatabase.net/k813627/ 1982-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k813627-bk-6453-rimmed-acrylic-lap-tray-kit-fda-510k.jpg K813627 - BK-6453 RIMMED ACRYLIC LAP TRAY KIT K813627 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jan 1982. https://www.510kdatabase.net/k813628/ 1982-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k813628-bk-7182-instant-cold-pack-fda-510k.jpg K813628 - BK-7182 INSTANT COLD PACK K813628 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jan 1982. https://www.510kdatabase.net/k813629/ 1982-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k813629-bk-6111-hi-d-transfer-board-fda-510k.jpg K813629 - BK-6111 HI-D TRANSFER BOARD K813629 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jan 1982. https://www.510kdatabase.net/k813630/ 1982-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k813630-bk-1129-bottle-straw-fda-510k.jpg K813630 - BK-1129 BOTTLE STRAW K813630 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jan 1982. https://www.510kdatabase.net/k813631/ 1982-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k813631-jar-holder-opener-fda-510k.jpg K813631 - JAR HOLDER & OPENER K813631 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jan 1982. https://www.510kdatabase.net/k813632/ 1982-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k813632-color-coded-weight-cuffs-fda-510k.jpg K813632 - COLOR CODED WEIGHT CUFFS K813632 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jan 1982. https://www.510kdatabase.net/k813633/ 1982-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k813633-modeling-compound-and-foam-exerciser-fda-510k.jpg K813633 - MODELING COMPOUND AND FOAM EXERCISER K813633 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jan 1982. https://www.510kdatabase.net/k813634/ 1982-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k813634-one-handed-shoe-fastener-fda-510k.jpg K813634 - ONE HANDED SHOE FASTENER K813634 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jan 1982. https://www.510kdatabase.net/k813635/ 1982-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k813635-childs-toilet-trainer-hygiene-aids-fda-510k.jpg K813635 - CHILDS TOILET TRAINER HYGIENE AIDS K813635 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jan 1982. https://www.510kdatabase.net/k813636/ 1982-01-19 monthly 0.5 https://www.510kdatabase.net/og-image/k813636-bk-6470-adjustable-elevating-wheelchair-fda-510k.jpg K813636 - BK-6470 ADJUSTABLE ELEVATING WHEELCHAIR K813636 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jan 1982. https://www.510kdatabase.net/k812768/ 1982-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k812768-coat-a-count-free-total-estriol-kit-fda-510k.jpg K812768 - COAT-A-COUNT FREE & TOTAL ESTRIOL KIT K812768 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jan 1982. https://www.510kdatabase.net/k813255/ 1982-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k813255-lpm50-membrane-oxygenator-fda-510k.jpg K813255 - LPM/50 MEMBRANE OXYGENATOR K813255 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Jan 1982. https://www.510kdatabase.net/k813580/ 1982-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k813580-q-line-ltc-fda-510k.jpg K813580 - Q-LINE LTC K813580 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Jan 1982. https://www.510kdatabase.net/k813180/ 1982-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k813180-scotchbond-dental-adhesive-fda-510k.jpg K813180 - SCOTCHBOND DENTAL ADHESIVE K813180 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Jan 1982. https://www.510kdatabase.net/k813518/ 1982-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k813518-implant-aid-splicing-crimp-sleeve-fda-510k.jpg K813518 - IMPLANT AID SPLICING CRIMP & SLEEVE K813518 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Jan 1982. https://www.510kdatabase.net/k813357/ 1982-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k813357-caulk-opaquer-fda-510k.jpg K813357 - CAULK OPAQUER K813357 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jan 1982. https://www.510kdatabase.net/k813479/ 1982-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k813479-argyle-pediatric-urine-collector-fda-510k.jpg K813479 - ARGYLE PEDIATRIC URINE COLLECTOR K813479 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Sherwood Medical Co.. Cleared Jan 1982. https://www.510kdatabase.net/k813480/ 1982-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k813480-monoject-m560-60cc-syringes-fda-510k.jpg K813480 - MONOJECT M560 60CC SYRINGES K813480 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Jan 1982. https://www.510kdatabase.net/k812322/ 1982-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k812322-arizona-radio-capitellar-total-elbow-fda-510k.jpg K812322 - ARIZONA RADIO CAPITELLAR TOTAL ELBOW K812322 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jan 1982. https://www.510kdatabase.net/k812858/ 1981-12-31 monthly 0.5 https://www.510kdatabase.net/og-image/k812858-chemfil-fda-510k.jpg K812858 - CHEMFIL K812858 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Dec 1981. https://www.510kdatabase.net/k813395/ 1981-12-31 monthly 0.5 https://www.510kdatabase.net/og-image/k813395-cellulose-acetate-citrate-agar-hemoglo-fda-510k.jpg K813395 - CELLULOSE ACETATE-CITRATE AGAR HEMOGLO K813395 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Helena Laboratories. Cleared Dec 1981. https://www.510kdatabase.net/k813403/ 1981-12-31 monthly 0.5 https://www.510kdatabase.net/og-image/k813403-flo-gard-8000-infusion-pump-system-fda-510k.jpg K813403 - FLO-GARD 8000 INFUSION PUMP SYSTEM K813403 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Dec 1981. https://www.510kdatabase.net/k813428/ 1981-12-31 monthly 0.5 https://www.510kdatabase.net/og-image/k813428-shunt-adapter-fda-510k.jpg K813428 - SHUNT ADAPTER K813428 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quinton, Inc.. Cleared Dec 1981. https://www.510kdatabase.net/k813441/ 1981-12-31 monthly 0.5 https://www.510kdatabase.net/og-image/k813441-piperacillin-100-mcg-sensi-disc-fda-510k.jpg K813441 - PIPERACILLIN 100 MCG. SENSI DISC K813441 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Dec 1981. https://www.510kdatabase.net/k813529/ 1981-12-31 monthly 0.5 https://www.510kdatabase.net/og-image/k813529-dade-colorimetric-amylase-fda-510k.jpg K813529 - DADE COLORIMETRIC AMYLASE K813529 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Dec 1981. https://www.510kdatabase.net/k812808/ 1981-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k812808-bbl-directigen-test-kit-fda-510k.jpg K812808 - BBL DIRECTIGEN TEST KIT K812808 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Dec 1981. https://www.510kdatabase.net/k812914/ 1981-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k812914-micro-preprocessor-unit-fda-510k.jpg K812914 - MICRO-PREPROCESSOR UNIT K812914 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: General Electric Co.. Cleared Dec 1981. https://www.510kdatabase.net/k813387/ 1981-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k813387-metronidazole-80mcg-sensi-disc-fda-510k.jpg K813387 - METRONIDAZOLE 80MCG. SENSI-DISC K813387 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Dec 1981. https://www.510kdatabase.net/k813442/ 1981-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k813442-cefinase-tm-discs-fda-510k.jpg K813442 - CEFINASE TM DISCS K813442 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Dec 1981. https://www.510kdatabase.net/k813444/ 1981-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k813444-nihon-kohden-heart-monitors-omp-7101-02-fda-510k.jpg K813444 - NIHON KOHDEN HEART MONITORS OMP 7101-02 K813444 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Dec 1981. https://www.510kdatabase.net/k813472/ 1981-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k813472-ls-5800-series-liquid-scintillation-fda-510k.jpg K813472 - LS 5800 SERIES LIQUID SCINTILLATION K813472 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Dec 1981. https://www.510kdatabase.net/k813369/ 1981-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k813369-gram-stain-reagents-and-kit-fda-510k.jpg K813369 - GRAM STAIN REAGENTS AND KIT K813369 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Dec 1981. https://www.510kdatabase.net/k813401/ 1981-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k813401-coat-a-count-testosterone-ria-kit-fda-510k.jpg K813401 - COAT-A-COUNT TESTOSTERONE RIA KIT K813401 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Dec 1981. https://www.510kdatabase.net/k813391/ 1981-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k813391-tobramycin-reagent-test-kit-fda-510k.jpg K813391 - TOBRAMYCIN REAGENT TEST KIT K813391 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Dec 1981. https://www.510kdatabase.net/k813031/ 1981-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k813031-ms-2-bacterial-identification-sys-fda-510k.jpg K813031 - MS-2 BACTERIAL IDENTIFICATION SYS K813031 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Dec 1981. https://www.510kdatabase.net/k813216/ 1981-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k813216-secure-fdi-test-kit-fda-510k.jpg K813216 - SECURE FDI TEST KIT K813216 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Dec 1981. https://www.510kdatabase.net/k812659/ 1981-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k812659-terumo-hollow-oxygenator-circuit-fda-510k.jpg K812659 - TERUMO HOLLOW OXYGENATOR CIRCUIT K812659 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Dec 1981. https://www.510kdatabase.net/k812660/ 1981-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k812660-terumo-hollow-fiber-oxygenator-fda-510k.jpg K812660 - TERUMO HOLLOW FIBER OXYGENATOR K812660 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Terumo Medical Corp.. Cleared Dec 1981. https://www.510kdatabase.net/k813147/ 1981-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k813147-kodak-intensifying-screen-80-175-fda-510k.jpg K813147 - KODAK INTENSIFYING SCREEN 80-175 K813147 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Dec 1981. https://www.510kdatabase.net/k813173/ 1981-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k813173-vrt-table-wintegrating-tube-standelev-fda-510k.jpg K813173 - VRT TABLE W/INTEGRATING TUBE STAND/ELEV K813173 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Dec 1981. https://www.510kdatabase.net/k813279/ 1981-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k813279-electrocardiograph-cm3000-fda-510k.jpg K813279 - ELECTROCARDIOGRAPH CM3000 K813279 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Dec 1981. https://www.510kdatabase.net/k813028/ 1981-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k813028-poly-flex-pacing-leads-fda-510k.jpg K813028 - POLY-FLEX PACING LEADS K813028 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Dec 1981. https://www.510kdatabase.net/k813138/ 1981-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k813138-ethicon-temp-cardiac-pacing-wire-fda-510k.jpg K813138 - ETHICON* TEMP. CARDIAC PACING WIRE K813138 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ethicon, Inc.. Cleared Dec 1981. https://www.510kdatabase.net/k813160/ 1981-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k813160-beckman-system-e4a-fda-510k.jpg K813160 - BECKMAN SYSTEM E4A K813160 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Dec 1981. https://www.510kdatabase.net/k813276/ 1981-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k813276-ionescu-shiley-valve-holder-handle-fda-510k.jpg K813276 - IONESCU-SHILEY VALVE HOLDER & HANDLE K813276 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Dec 1981. https://www.510kdatabase.net/k813155/ 1981-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k813155-pediatric-ventilator-circuit-2c7131-fda-510k.jpg K813155 - PEDIATRIC VENTILATOR CIRCUIT 2C7131 K813155 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Dec 1981. https://www.510kdatabase.net/k812976/ 1981-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k812976-argyle-acc-u-therm-wtemperature-probe-fda-510k.jpg K812976 - ARGYLE ACC-U-THERM W/TEMPERATURE PROBE K812976 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sherwood Medical Co.. Cleared Dec 1981. https://www.510kdatabase.net/k813065/ 1981-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k813065-bdas-fda-510k.jpg K813065 - B.D.A.S. K813065 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Dec 1981. https://www.510kdatabase.net/k813124/ 1981-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k813124-ethicon-skin-closure-tape-fda-510k.jpg K813124 - ETHICON* SKIN CLOSURE TAPE K813124 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Dec 1981. https://www.510kdatabase.net/k813139/ 1981-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k813139-kodak-intensifying-screen-so-168-fda-510k.jpg K813139 - KODAK INTENSIFYING SCREEN SO-168 K813139 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Dec 1981. https://www.510kdatabase.net/k813218/ 1981-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k813218-tdx-vancomycin-fda-510k.jpg K813218 - TDX VANCOMYCIN K813218 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Dec 1981. https://www.510kdatabase.net/k813240/ 1981-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k813240-emit-aad-theophylline-assay-fda-510k.jpg K813240 - EMIT-AAD THEOPHYLLINE ASSAY K813240 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Dec 1981. https://www.510kdatabase.net/k813241/ 1981-12-03 monthly 0.5 https://www.510kdatabase.net/og-image/k813241-emit-aad-theophylline-control-fda-510k.jpg K813241 - EMIT-AAD THEOPHYLLINE CONTROL K813241 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Dec 1981. https://www.510kdatabase.net/k813008/ 1981-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k813008-respond-iineuromuscular-stimulator-fda-510k.jpg K813008 - RESPOND II...NEUROMUSCULAR STIMULATOR K813008 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Medtronic Vascular. Cleared Dec 1981. https://www.510kdatabase.net/k813194/ 1981-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k813194-auto-syringe-sub-cuteaneous-set-fda-510k.jpg K813194 - AUTO-SYRINGE SUB-CUTEANEOUS SET K813194 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Dec 1981. https://www.510kdatabase.net/k813123/ 1981-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k813123-epc-filter-fda-510k.jpg K813123 - EPC FILTER K813123 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Nov 1981. https://www.510kdatabase.net/k813146/ 1981-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k813146-syva-advance-tm-fluorometer-fda-510k.jpg K813146 - SYVA ADVANCE TM FLUOROMETER K813146 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Nov 1981. https://www.510kdatabase.net/k812626/ 1981-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k812626-aca-antithrombin-iii-plasminogen-calib-fda-510k.jpg K812626 - ACA ANTITHROMBIN III PLASMINOGEN CALIB K812626 is a FDA 510(k) cleared immunology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Nov 1981. https://www.510kdatabase.net/k812628/ 1981-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k812628-aca-fibrinogen-calibrator-fda-510k.jpg K812628 - ACA FIBRINOGEN CALIBRATOR K812628 is a FDA 510(k) cleared hematology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Nov 1981. https://www.510kdatabase.net/k812913/ 1981-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k812913-omega-ii-angiographic-table-fda-510k.jpg K812913 - OMEGA II ANGIOGRAPHIC TABLE K812913 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Nov 1981. https://www.510kdatabase.net/k812915/ 1981-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k812915-mx-125-fda-510k.jpg K812915 - MX 125 K812915 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Nov 1981. https://www.510kdatabase.net/k812929/ 1981-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k812929-35-mhz-biopsy-transducer-fda-510k.jpg K812929 - 3.5 MHZ BIOPSY TRANSDUCER K812929 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Nov 1981. https://www.510kdatabase.net/k812966/ 1981-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k812966-400t-ect-software-fda-510k.jpg K812966 - 400T ECT SOFTWARE K812966 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Nov 1981. https://www.510kdatabase.net/k813005/ 1981-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k813005-kodak-cinefluorographic-film-so-274-fda-510k.jpg K813005 - KODAK CINEFLUOROGRAPHIC FILM SO-274 K813005 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Nov 1981. https://www.510kdatabase.net/k813148/ 1981-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k813148-sp-vortex-mixer-fda-510k.jpg K813148 - S/P VORTEX MIXER K813148 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Nov 1981. https://www.510kdatabase.net/k813149/ 1981-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k813149-sp-vortex-mixer-jr-fda-510k.jpg K813149 - S/P VORTEX MIXER JR. K813149 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Nov 1981. https://www.510kdatabase.net/k812819/ 1981-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k812819-ethicon-surgical-sutures-wcompress-bol-fda-510k.jpg K812819 - ETHICON* SURGICAL SUTURES W/COMPRESS BOL K812819 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Nov 1981. https://www.510kdatabase.net/k813089/ 1981-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k813089-cement-ring-fda-510k.jpg K813089 - CEMENT RING K813089 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Nov 1981. https://www.510kdatabase.net/k813080/ 1981-11-17 monthly 0.5 https://www.510kdatabase.net/og-image/k813080-wound-drainage-management-systems-fda-510k.jpg K813080 - WOUND DRAINAGE MANAGEMENT SYSTEMS K813080 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Howmedica Corp.. Cleared Nov 1981. https://www.510kdatabase.net/k812323/ 1981-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k812323-pds-absorbable-ligating-clips-fda-510k.jpg K812323 - PDS* ABSORBABLE LIGATING CLIPS K812323 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Nov 1981. https://www.510kdatabase.net/k812725/ 1981-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k812725-model-5867-12-bipolar-low-profile-lead-fda-510k.jpg K812725 - MODEL 5867-12 BIPOLAR LOW-PROFILE LEAD K812725 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Nov 1981. https://www.510kdatabase.net/k812755/ 1981-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k812755-model-535-03-trace-a-pace-fda-510k.jpg K812755 - MODEL 535-03 TRACE A PACE K812755 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Nov 1981. https://www.510kdatabase.net/k812827/ 1981-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k812827-orbic-spherical-alloy-fda-510k.jpg K812827 - ORBIC* SPHERICAL ALLOY K812827 is a FDA 510(k) cleared dental medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Nov 1981. https://www.510kdatabase.net/k812828/ 1981-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k812828-model-2000-monitor-fda-510k.jpg K812828 - MODEL 2000 MONITOR K812828 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Nov 1981. https://www.510kdatabase.net/k812974/ 1981-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k812974-lancer-coagent-human-factor-1x-plasma-fda-510k.jpg K812974 - LANCER COAGENT HUMAN FACTOR 1X PLASMA K812974 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sherwood Medical Co.. Cleared Nov 1981. https://www.510kdatabase.net/k812975/ 1981-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k812975-lancer-coagent-human-vactor-viii-plasma-fda-510k.jpg K812975 - LANCER COAGENT HUMAN VACTOR VIII PLASMA K812975 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sherwood Medical Co.. Cleared Nov 1981. https://www.510kdatabase.net/k812989/ 1981-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k812989-intermedics-polyflex-model-493-03-lead-fda-510k.jpg K812989 - INTERMEDICS POLYFLEX-MODEL 493-03 LEAD K812989 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Nov 1981. https://www.510kdatabase.net/k812990/ 1981-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k812990-intermedics-polyflex-model-483-03-lead-fda-510k.jpg K812990 - INTERMEDICS POLYFLEX-MODEL 483-03 LEAD K812990 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Nov 1981. https://www.510kdatabase.net/k812991/ 1981-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k812991-intermedics-polyflex-model-483-04-lead-fda-510k.jpg K812991 - INTERMEDICS POLYFLEX-MODEL 483-04 LEAD K812991 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Nov 1981. https://www.510kdatabase.net/k813066/ 1981-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k813066-argyle-yankauer-suction-tube-fda-510k.jpg K813066 - ARGYLE YANKAUER SUCTION TUBE K813066 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Nov 1981. https://www.510kdatabase.net/k811924/ 1981-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k811924-pre-filled-syringe-cystoflo-urinary-bg-fda-510k.jpg K811924 - PRE-FILLED SYRINGE & CYSTOFLO URINARY BG K811924 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Nov 1981. https://www.510kdatabase.net/k812315/ 1981-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k812315-bactec-resin-culture-med-16a-fda-510k.jpg K812315 - BACTEC RESIN CULTURE MED. 16A K812315 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Nov 1981. https://www.510kdatabase.net/k812865/ 1981-11-10 monthly 0.5 https://www.510kdatabase.net/og-image/k812865-quantumatic-dual-wavelength-spectro-fda-510k.jpg K812865 - QUANTUMATIC DUAL-WAVELENGTH SPECTRO K812865 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1981. https://www.510kdatabase.net/k812137/ 1981-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k812137-b-d-heparinized-longdwel-iv-catheter-fda-510k.jpg K812137 - B-D HEPARINIZED LONGDWEL I.V. CATHETER K812137 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Nov 1981. https://www.510kdatabase.net/k812775/ 1981-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k812775-fluoricon-l300-image-intensifier-fda-510k.jpg K812775 - FLUORICON L300 IMAGE INTENSIFIER K812775 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Nov 1981. https://www.510kdatabase.net/k812921/ 1981-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k812921-sp-sure-cap-fda-510k.jpg K812921 - S/P SURE-CAP K812921 is a FDA 510(k) cleared hematology medical device. Manufacturer: American Dade. Cleared Nov 1981. https://www.510kdatabase.net/k812922/ 1981-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k812922-sp-sure-cap-c-fda-510k.jpg K812922 - S/P SURE-CAP C K812922 is a FDA 510(k) cleared hematology medical device. Manufacturer: American Dade. Cleared Nov 1981. https://www.510kdatabase.net/k812923/ 1981-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k812923-sp-sure-cap-n-fda-510k.jpg K812923 - S/P SURE-CAP N K812923 is a FDA 510(k) cleared hematology medical device. Manufacturer: American Dade. Cleared Nov 1981. https://www.510kdatabase.net/k812926/ 1981-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k812926-alt-quantichrom-fda-510k.jpg K812926 - ALT-QUANTICHROM K812926 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1981. https://www.510kdatabase.net/k812933/ 1981-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k812933-lancer-specimen-container-fda-510k.jpg K812933 - LANCER SPECIMEN CONTAINER K812933 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Nov 1981. https://www.510kdatabase.net/k812934/ 1981-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k812934-monoject-prefilled-syringes-fda-510k.jpg K812934 - MONOJECT PREFILLED SYRINGES K812934 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Nov 1981. https://www.510kdatabase.net/k812946/ 1981-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k812946-tronzo-hip-fda-510k.jpg K812946 - TRONZO HIP K812946 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Biomet, Inc.. Cleared Nov 1981. https://www.510kdatabase.net/k812969/ 1981-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k812969-sp-capillary-tubes-heparinized-2a-fda-510k.jpg K812969 - S/P CAPILLARY TUBES, HEPARINIZED (2A) K812969 is a FDA 510(k) cleared hematology medical device. Manufacturer: American Dade. Cleared Nov 1981. https://www.510kdatabase.net/k812970/ 1981-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k812970-sp-capillary-tubes-heparinized-3a-fda-510k.jpg K812970 - S/P CAPILLARY TUBES, HEPARINIZED (3A) K812970 is a FDA 510(k) cleared hematology medical device. Manufacturer: American Dade. Cleared Nov 1981. https://www.510kdatabase.net/k812978/ 1981-11-06 monthly 0.5 https://www.510kdatabase.net/og-image/k812978-uric-acid-system-pack-test-fda-510k.jpg K812978 - URIC ACID SYSTEM PACK TEST K812978 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Nov 1981. https://www.510kdatabase.net/k812556/ 1981-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k812556-dade-immu-trace-tri-rac-r-tri-level-rc-fda-510k.jpg K812556 - DADE IMMU-TRACE TRI-RAC R TRI-LEVEL R.C K812556 is a FDA 510(k) cleared immunology medical device. Manufacturer: American Dade. Cleared Nov 1981. https://www.510kdatabase.net/k812742/ 1981-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k812742-shiley-arterial-filter-w40-micron-scree-fda-510k.jpg K812742 - SHILEY ARTERIAL FILTER W/40 MICRON SCREE K812742 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Nov 1981. https://www.510kdatabase.net/k812867/ 1981-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k812867-steri-vac-400c-gas-sterilizer-fda-510k.jpg K812867 - STERI-VAC #400C GAS STERILIZER K812867 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Nov 1981. https://www.510kdatabase.net/k812874/ 1981-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k812874-pediatric-microaggregate-blood-filter-fda-510k.jpg K812874 - PEDIATRIC MICROAGGREGATE BLOOD FILTER K812874 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1981. https://www.510kdatabase.net/k812756/ 1981-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k812756-adaptaid-365-38-fda-510k.jpg K812756 - ADAPTAID #365-38 K812756 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Oct 1981. https://www.510kdatabase.net/k812781/ 1981-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k812781-temporary-pervenous-j-atrial-lead-fda-510k.jpg K812781 - TEMPORARY PERVENOUS J-ATRIAL LEAD K812781 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Oct 1981. https://www.510kdatabase.net/k812812/ 1981-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k812812-intermedics-adaptaid-step-down-adapter-fda-510k.jpg K812812 - INTERMEDICS ADAPTAID STEP-DOWN ADAPTER K812812 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Oct 1981. https://www.510kdatabase.net/k812813/ 1981-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k812813-intermedics-programmer-model-522-03-fda-510k.jpg K812813 - INTERMEDICS PROGRAMMER, MODEL 522-03 K812813 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Oct 1981. https://www.510kdatabase.net/k812892/ 1981-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k812892-sp-serum-dropper-pipets-fda-510k.jpg K812892 - S/P SERUM DROPPER PIPETS K812892 is a FDA 510(k) cleared hematology medical device. Manufacturer: American Dade. Cleared Oct 1981. https://www.510kdatabase.net/k812872/ 1981-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k812872-optional-total-ca-module-for-il-504508-fda-510k.jpg K812872 - OPTIONAL TOTAL CA-MODULE FOR IL 504/508 K812872 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Oct 1981. https://www.510kdatabase.net/k812428/ 1981-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k812428-helena-coloscreen-method-fda-510k.jpg K812428 - HELENA COLOSCREEN METHOD K812428 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Oct 1981. https://www.510kdatabase.net/k812599/ 1981-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k812599-medtronic-4951-fda-510k.jpg K812599 - MEDTRONIC #4951 K812599 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Oct 1981. https://www.510kdatabase.net/k812703/ 1981-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k812703-model-9408-a-teletrace-fda-510k.jpg K812703 - MODEL 9408 A TELETRACE K812703 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Oct 1981. https://www.510kdatabase.net/k812747/ 1981-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k812747-argyle-suction-catheters-fda-510k.jpg K812747 - ARGYLE SUCTION CATHETERS K812747 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sherwood Medical Co.. Cleared Oct 1981. https://www.510kdatabase.net/k812748/ 1981-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k812748-monoject-m535-35cc-syringe-fda-510k.jpg K812748 - MONOJECT M535 35CC SYRINGE K812748 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Oct 1981. https://www.510kdatabase.net/k812844/ 1981-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k812844-moxalactam-30mcg-sensi-disc-fda-510k.jpg K812844 - MOXALACTAM 30MCG. SENSI-DISC K812844 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1981. https://www.510kdatabase.net/k812762/ 1981-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k812762-il-501-nak-analyzer-fda-510k.jpg K812762 - IL 501, NA/K ANALYZER K812762 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Oct 1981. https://www.510kdatabase.net/k812784/ 1981-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k812784-beckman-astra-sys-total-bilirubin-mod-fda-510k.jpg K812784 - BECKMAN ASTRA SYS. TOTAL BILIRUBIN MOD K812784 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Oct 1981. https://www.510kdatabase.net/k812801/ 1981-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k812801-hip-stem-system-titanium-alloy-fda-510k.jpg K812801 - HIP STEM SYSTEM TITANIUM ALLOY K812801 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Oct 1981. https://www.510kdatabase.net/k812535/ 1981-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k812535-plastilix-minirad-d-cassette-fda-510k.jpg K812535 - PLASTILIX MINIRAD D CASSETTE K812535 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Oct 1981. https://www.510kdatabase.net/k812649/ 1981-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k812649-beckman-ics-calibrator-fda-510k.jpg K812649 - BECKMAN ICS CALIBRATOR K812649 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Oct 1981. https://www.510kdatabase.net/k812650/ 1981-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k812650-beckman-ics-normal-control-sera-fda-510k.jpg K812650 - BECKMAN ICS NORMAL CONTROL SERA K812650 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Oct 1981. https://www.510kdatabase.net/k812704/ 1981-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k812704-neuromed-selectra-7720-fda-510k.jpg K812704 - NEUROMED SELECTRA #7720 K812704 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Oct 1981. https://www.510kdatabase.net/k812717/ 1981-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k812717-non-sterile-shadow-stripe-catheter-fda-510k.jpg K812717 - NON-STERILE SHADOW-STRIPE CATHETER K812717 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quinton, Inc.. Cleared Oct 1981. https://www.510kdatabase.net/k812718/ 1981-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k812718-cuff-material-on-pediatric-size-cath-fda-510k.jpg K812718 - CUFF MATERIAL ON PEDIATRIC SIZE CATH. K812718 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quinton, Inc.. Cleared Oct 1981. https://www.510kdatabase.net/k812753/ 1981-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k812753-ames-tda-quinidine-test-fda-510k.jpg K812753 - AMES TDA QUINIDINE TEST K812753 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Oct 1981. https://www.510kdatabase.net/k812754/ 1981-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k812754-beckman-astra-systems-direct-bilirubin-fda-510k.jpg K812754 - BECKMAN ASTRA SYSTEMS DIRECT BILIRUBIN K812754 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Oct 1981. https://www.510kdatabase.net/k812502/ 1981-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k812502-implantaid-lead-introducer-319-10-12-fda-510k.jpg K812502 - IMPLANTAID LEAD INTRODUCER #319-10 & 12 K812502 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Oct 1981. https://www.510kdatabase.net/k812509/ 1981-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k812509-ctt-8800-fda-510k.jpg K812509 - CT/T 8800 K812509 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Oct 1981. https://www.510kdatabase.net/k812561/ 1981-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k812561-lateral-angulating-fluoro-suspension-sys-fda-510k.jpg K812561 - LATERAL ANGULATING FLUORO SUSPENSION SYS K812561 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Oct 1981. https://www.510kdatabase.net/k812155/ 1981-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k812155-medtronic-dual-channel-spinal-cord-stim-fda-510k.jpg K812155 - MEDTRONIC DUAL CHANNEL SPINAL CORD STIM K812155 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Oct 1981. https://www.510kdatabase.net/k812627/ 1981-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k812627-aca-antithrombin-iii-test-pack-fda-510k.jpg K812627 - ACA ANTITHROMBIN III TEST PACK K812627 is a FDA 510(k) cleared hematology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Oct 1981. https://www.510kdatabase.net/k812629/ 1981-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k812629-aca-fibrinogen-test-pack-fda-510k.jpg K812629 - ACA FIBRINOGEN TEST PACK K812629 is a FDA 510(k) cleared hematology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Oct 1981. https://www.510kdatabase.net/k812672/ 1981-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k812672-self-centering-hip-fda-510k.jpg K812672 - SELF-CENTERING HIP K812672 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Oct 1981. https://www.510kdatabase.net/k812697/ 1981-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k812697-hema-20-micron-transfusion-blood-filter-fda-510k.jpg K812697 - HEMA 20 MICRON TRANSFUSION BLOOD FILTER K812697 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1981. https://www.510kdatabase.net/k812221/ 1981-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k812221-intermedics-poly-flex-epicardial-suture-fda-510k.jpg K812221 - INTERMEDICS POLY FLEX EPICARDIAL SUTURE K812221 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Oct 1981. https://www.510kdatabase.net/k812245/ 1981-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k812245-intermedics-poly-flex-endocardial-atrial-fda-510k.jpg K812245 - INTERMEDICS POLY FLEX ENDOCARDIAL ATRIAL K812245 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Oct 1981. https://www.510kdatabase.net/k812571/ 1981-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k812571-mezlocillin-75-mcg-sensi-disc-fda-510k.jpg K812571 - MEZLOCILLIN 75 MCG. SENSI-DISC K812571 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1981. https://www.510kdatabase.net/k812698/ 1981-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k812698-gc-disk-fda-510k.jpg K812698 - GC DISK K812698 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Oct 1981. https://www.510kdatabase.net/k812286/ 1981-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k812286-miniteck-enteric-broth-enterobacter-fda-510k.jpg K812286 - MINITECK ENTERIC BROTH & ENTEROBACTER K812286 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1981. https://www.510kdatabase.net/k812424/ 1981-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k812424-ci-trol-heparin-controls-lowhigh-fda-510k.jpg K812424 - CI-TROL HEPARIN CONTROLS, LOW/HIGH K812424 is a FDA 510(k) cleared hematology medical device. Manufacturer: American Dade. Cleared Oct 1981. https://www.510kdatabase.net/k812570/ 1981-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k812570-labcer-fibrinogen-assay-kit-calibr-fda-510k.jpg K812570 - LABCER FIBRINOGEN ASSAY KIT & CALIBR. K812570 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sherwood Medical Co.. Cleared Oct 1981. https://www.510kdatabase.net/k812607/ 1981-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k812607-tenckhoff-peritoneal-catheters-fda-510k.jpg K812607 - TENCKHOFF PERITONEAL CATHETERS K812607 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quinton, Inc.. Cleared Oct 1981. https://www.510kdatabase.net/k812647/ 1981-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k812647-emit-auto-carousel-fda-510k.jpg K812647 - EMIT AUTO CAROUSEL K812647 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Oct 1981. https://www.510kdatabase.net/k812664/ 1981-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k812664-aca-immunoglobulin-g-analytical-test-fda-510k.jpg K812664 - ACA IMMUNOGLOBULIN G ANALYTICAL TEST K812664 is a FDA 510(k) cleared immunology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Oct 1981. https://www.510kdatabase.net/k812688/ 1981-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k812688-qi-1150-1t-infusion-t-fda-510k.jpg K812688 - QI 1150-1T INFUSION T K812688 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Quinton, Inc.. Cleared Oct 1981. https://www.510kdatabase.net/k812498/ 1981-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k812498-clirans-te12-hollow-fiber-dialyzer-fda-510k.jpg K812498 - CLIRANS TE12 HOLLOW FIBER DIALYZER K812498 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Terumo Medical Corp.. Cleared Sep 1981. https://www.510kdatabase.net/k812558/ 1981-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k812558-tissue-tek-iii-accu-cut-rotary-microtome-fda-510k.jpg K812558 - TISSUE-TEK III ACCU-CUT ROTARY MICROTOME K812558 is a FDA 510(k) cleared hematology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Sep 1981. https://www.510kdatabase.net/k812625/ 1981-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k812625-aca-plasminogen-test-pack-fda-510k.jpg K812625 - ACA PLASMINOGEN TEST PACK K812625 is a FDA 510(k) cleared immunology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Sep 1981. https://www.510kdatabase.net/k812630/ 1981-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k812630-aca-immunoglobulin-g-calibrator-fda-510k.jpg K812630 - ACA IMMUNOGLOBULIN G CALIBRATOR K812630 is a FDA 510(k) cleared immunology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Sep 1981. https://www.510kdatabase.net/k812631/ 1981-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k812631-aca-immunoglobin-a-test-pack-fda-510k.jpg K812631 - ACA IMMUNOGLOBIN A TEST PACK K812631 is a FDA 510(k) cleared immunology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Sep 1981. https://www.510kdatabase.net/k812632/ 1981-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k812632-aca-immunoglobin-m-test-pack-fda-510k.jpg K812632 - ACA IMMUNOGLOBIN M TEST PACK K812632 is a FDA 510(k) cleared immunology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Sep 1981. https://www.510kdatabase.net/k812633/ 1981-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k812633-aca-immunoglobulin-am-calibrators-fda-510k.jpg K812633 - ACA IMMUNOGLOBULIN A/M CALIBRATORS K812633 is a FDA 510(k) cleared immunology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Sep 1981. https://www.510kdatabase.net/k812449/ 1981-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k812449-adaptic-cfs-fda-510k.jpg K812449 - ADAPTIC* C.F.S. K812449 is a FDA 510(k) cleared dental medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Sep 1981. https://www.510kdatabase.net/k812569/ 1981-09-25 monthly 0.5 https://www.510kdatabase.net/og-image/k812569-sherwood-water-trap-fda-510k.jpg K812569 - SHERWOOD WATER TRAP K812569 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sherwood Medical Co.. Cleared Sep 1981. https://www.510kdatabase.net/k812012/ 1981-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k812012-townley-unicondylar-knee-fda-510k.jpg K812012 - TOWNLEY UNICONDYLAR KNEE K812012 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Sep 1981. https://www.510kdatabase.net/k812540/ 1981-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k812540-cordia-im-fda-510k.jpg K812540 - CORDIA IM K812540 is a FDA 510(k) cleared immunology medical device. Manufacturer: Cordis Corp.. Cleared Sep 1981. https://www.510kdatabase.net/k812583/ 1981-09-24 monthly 0.5 https://www.510kdatabase.net/og-image/k812583-bovine-chemistry-control-ix-iix-fda-510k.jpg K812583 - BOVINE CHEMISTRY CONTROL I.X. & II.X. K812583 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Sep 1981. https://www.510kdatabase.net/k801337/ 1981-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k801337-cyberlith-ix-implantable-pulse-generator-fda-510k.jpg K801337 - CYBERLITH IX IMPLANTABLE PULSE GENERATOR K801337 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Sep 1981. https://www.510kdatabase.net/k801339/ 1981-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k801339-telemetry-decoder-fda-510k.jpg K801339 - TELEMETRY DECODER K801339 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Sep 1981. https://www.510kdatabase.net/k811464/ 1981-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k811464-model-535-01-trace-a-pace-ekgtelemetry-fda-510k.jpg K811464 - MODEL 535-01 TRACE-A-PACE EKG/TELEMETRY K811464 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Sep 1981. https://www.510kdatabase.net/k812338/ 1981-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k812338-preza-pak-ii-arterial-blood-sampling-sy-fda-510k.jpg K812338 - PREZA-PAK II, ARTERIAL BLOOD SAMPLING SY K812338 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Terumo Medical Corp.. Cleared Sep 1981. https://www.510kdatabase.net/k812425/ 1981-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k812425-beckman-rpr-control-serum-set-fda-510k.jpg K812425 - BECKMAN R.PR CONTROL SERUM SET K812425 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Sep 1981. https://www.510kdatabase.net/k812431/ 1981-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k812431-factor-viii-deficient-plasma-b8d-fda-510k.jpg K812431 - FACTOR VIII DEFICIENT PLASMA #B8D K812431 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Chemical Co.. Cleared Sep 1981. https://www.510kdatabase.net/k812518/ 1981-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k812518-ames-tda-theophylline-test-fda-510k.jpg K812518 - AMES TDA THEOPHYLLINE TEST K812518 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Sep 1981. https://www.510kdatabase.net/k812541/ 1981-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k812541-protein-based-blood-gas-control-fda-510k.jpg K812541 - PROTEIN-BASED BLOOD GAS CONTROL K812541 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Sep 1981. https://www.510kdatabase.net/k812580/ 1981-09-23 monthly 0.5 https://www.510kdatabase.net/og-image/k812580-medtronic-model-2409-fda-510k.jpg K812580 - MEDTRONIC MODEL 2409 K812580 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Sep 1981. https://www.510kdatabase.net/k810913/ 1981-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k810913-cavity-varnish-fda-510k.jpg K810913 - CAVITY VARNISH K810913 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Sep 1981. https://www.510kdatabase.net/k811830/ 1981-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k811830-c-dak-duo-flux-artificial-kidney-fda-510k.jpg K811830 - C-DAK DUO-FLUX ARTIFICIAL KIDNEY K811830 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Sep 1981. https://www.510kdatabase.net/k812259/ 1981-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k812259-nivp-monitor-fda-510k.jpg K812259 - NIVP MONITOR K812259 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Sep 1981. https://www.510kdatabase.net/k812307/ 1981-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k812307-usci-transthoracic-temp-pacing-electrod-fda-510k.jpg K812307 - USCI TRANSTHORACIC TEMP. PACING ELECTROD K812307 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Sep 1981. https://www.510kdatabase.net/k812317/ 1981-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k812317-defibrillatormonitor-fda-510k.jpg K812317 - DEFIBRILLATOR/MONITOR K812317 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Sep 1981. https://www.510kdatabase.net/k811718/ 1981-09-18 monthly 0.5 https://www.510kdatabase.net/og-image/k811718-surface-replacement-hip-prosthesis-fda-510k.jpg K811718 - SURFACE REPLACEMENT HIP PROSTHESIS K811718 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Biomet, Inc.. Cleared Sep 1981. https://www.510kdatabase.net/k801550/ 1981-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k801550-3m-germicidal-surgical-incise-drape-fda-510k.jpg K801550 - 3M GERMICIDAL SURGICAL INCISE DRAPE K801550 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Sep 1981. https://www.510kdatabase.net/k811841/ 1981-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k811841-gore-tex-cardiovascular-patch-fda-510k.jpg K811841 - GORE-TEX CARDIOVASCULAR PATCH K811841 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Sep 1981. https://www.510kdatabase.net/k812096/ 1981-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k812096-medtronic-enertrax-model-7100-fda-510k.jpg K812096 - MEDTRONIC ENERTRAX MODEL 7100 K812096 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Sep 1981. https://www.510kdatabase.net/k812418/ 1981-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k812418-medtronic-3798-electrode-fda-510k.jpg K812418 - MEDTRONIC #3798 ELECTRODE K812418 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Sep 1981. https://www.510kdatabase.net/k812442/ 1981-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k812442-3m-infusion-system-fda-510k.jpg K812442 - 3M INFUSION SYSTEM K812442 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Sep 1981. https://www.510kdatabase.net/k812510/ 1981-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k812510-travenol-infusion-controller-2m8052-fda-510k.jpg K812510 - TRAVENOL INFUSION CONTROLLER 2M8052 K812510 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Sep 1981. https://www.510kdatabase.net/k812351/ 1981-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k812351-non-measuring-exercisers-fda-510k.jpg K812351 - NON-MEASURING EXERCISERS K812351 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Sep 1981. https://www.510kdatabase.net/k812352/ 1981-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k812352-hygiene-adaptors-fda-510k.jpg K812352 - HYGIENE ADAPTORS K812352 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Sep 1981. https://www.510kdatabase.net/k811753/ 1981-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k811753-surgeons-gloves-fda-510k.jpg K811753 - SURGEON'S GLOVES K811753 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Sep 1981. https://www.510kdatabase.net/k811935/ 1981-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k811935-prolene-polypropylene-ligating-clip-fda-510k.jpg K811935 - PROLENE POLYPROPYLENE LIGATING CLIP K811935 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Sep 1981. https://www.510kdatabase.net/k812291/ 1981-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k812291-ethicon-multiple-ligating-clip-applier-fda-510k.jpg K812291 - ETHICON MULTIPLE LIGATING CLIP APPLIER K812291 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Sep 1981. https://www.510kdatabase.net/k812343/ 1981-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k812343-pinch-meter-fda-510k.jpg K812343 - PINCH METER K812343 is a FDA 510(k) cleared neurology medical device. Manufacturer: Fred Sammons, Inc.. Cleared Sep 1981. https://www.510kdatabase.net/k812344/ 1981-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k812344-heel-or-elbow-protector-fda-510k.jpg K812344 - HEEL OR ELBOW PROTECTOR K812344 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Fred Sammons, Inc.. Cleared Sep 1981. https://www.510kdatabase.net/k812345/ 1981-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k812345-arm-slings-fda-510k.jpg K812345 - ARM SLINGS K812345 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Sep 1981. https://www.510kdatabase.net/k812346/ 1981-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k812346-aluminum-scoop-disk-fda-510k.jpg K812346 - ALUMINUM SCOOP DISK K812346 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Sep 1981. https://www.510kdatabase.net/k812347/ 1981-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k812347-raised-chair-wfoot-platform-fda-510k.jpg K812347 - RAISED CHAIR W/FOOT PLATFORM K812347 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Sep 1981. https://www.510kdatabase.net/k812348/ 1981-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k812348-desk-arm-wheelchair-arm-extension-fda-510k.jpg K812348 - DESK ARM WHEELCHAIR ARM EXTENSION K812348 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Sep 1981. https://www.510kdatabase.net/k812349/ 1981-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k812349-hand-splints-components-fda-510k.jpg K812349 - HAND SPLINTS & COMPONENTS K812349 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Sep 1981. https://www.510kdatabase.net/k812350/ 1981-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k812350-wheelchair-accessories-fda-510k.jpg K812350 - WHEELCHAIR ACCESSORIES K812350 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Sep 1981. https://www.510kdatabase.net/k812237/ 1981-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k812237-hemotology-quality-control-mixture-fda-510k.jpg K812237 - HEMOTOLOGY QUALITY CONTROL MIXTURE K812237 is a FDA 510(k) cleared hematology medical device. Manufacturer: American Dade. Cleared Sep 1981. https://www.510kdatabase.net/k812241/ 1981-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k812241-ctt-9800-fda-510k.jpg K812241 - CT/T 9800 K812241 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Sep 1981. https://www.510kdatabase.net/k812242/ 1981-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k812242-cordisnhyperion-hemoglobin-a1-test-sys-fda-510k.jpg K812242 - CORDISNHYPERION HEMOGLOBIN A1 TEST SYS K812242 is a FDA 510(k) cleared hematology medical device. Manufacturer: Cordis Corp.. Cleared Sep 1981. https://www.510kdatabase.net/k812280/ 1981-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k812280-hematology-control-fda-510k.jpg K812280 - HEMATOLOGY CONTROL K812280 is a FDA 510(k) cleared hematology medical device. Manufacturer: American Dade. Cleared Sep 1981. https://www.510kdatabase.net/k812339/ 1981-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k812339-terufusion-infusion-pump-model-stc-502-fda-510k.jpg K812339 - TERUFUSION INFUSION PUMP MODEL STC-502 K812339 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terumo Medical Corp.. Cleared Sep 1981. https://www.510kdatabase.net/k811629/ 1981-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k811629-dyna-mo-fda-510k.jpg K811629 - DYNA- MO K811629 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Sep 1981. https://www.510kdatabase.net/k811925/ 1981-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k811925-uroflowmeter-fda-510k.jpg K811925 - UROFLOWMETER K811925 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Sep 1981. https://www.510kdatabase.net/k812302/ 1981-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k812302-shiley-fenestrated-low-press-cuffed-fda-510k.jpg K812302 - SHILEY FENESTRATED LOW PRESS. CUFFED K812302 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shiley, Inc.. Cleared Sep 1981. https://www.510kdatabase.net/k811342/ 1981-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k811342-reagent-strips-for-urinalysis-fda-510k.jpg K811342 - REAGENT STRIPS FOR URINALYSIS K811342 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Sep 1981. https://www.510kdatabase.net/k812226/ 1981-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k812226-helena-hbf-quiplate-control-fda-510k.jpg K812226 - HELENA HBF QUIPLATE CONTROL K812226 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Sep 1981. https://www.510kdatabase.net/k812303/ 1981-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k812303-glucose-hk-system-pack-test-fda-510k.jpg K812303 - GLUCOSE-HK SYSTEM PACK TEST K812303 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Sep 1981. https://www.510kdatabase.net/k811805/ 1981-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k811805-trypin-125i-ria-kit-fda-510k.jpg K811805 - TRYPIN (125I) RIA KIT K811805 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1981. https://www.510kdatabase.net/k812095/ 1981-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k812095-enxymatic-creatinine-test-fda-510k.jpg K812095 - ENXYMATIC CREATININE TEST K812095 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Aug 1981. https://www.510kdatabase.net/k812153/ 1981-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k812153-medtronic-spectrax-fda-510k.jpg K812153 - MEDTRONIC SPECTRAX K812153 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Aug 1981. https://www.510kdatabase.net/k812167/ 1981-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k812167-model-78850-oxygen-monitor-fda-510k.jpg K812167 - MODEL 78850 OXYGEN MONITOR K812167 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Aug 1981. https://www.510kdatabase.net/k812168/ 1981-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k812168-cordis-ducor-percut-trans-angio-cath-fda-510k.jpg K812168 - CORDIS DUCOR PERCUT. TRANS. ANGIO. CATH. K812168 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Aug 1981. https://www.510kdatabase.net/k812254/ 1981-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k812254-dacron-pledget-suture-buttress-fda-510k.jpg K812254 - DACRON PLEDGET SUTURE BUTTRESS K812254 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ethicon, Inc.. Cleared Aug 1981. https://www.510kdatabase.net/k812271/ 1981-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k812271-central-station-monitor-fda-510k.jpg K812271 - CENTRAL STATION MONITOR K812271 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Aug 1981. https://www.510kdatabase.net/k812285/ 1981-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k812285-monoject-sterile-corvac-blood-tube-fda-510k.jpg K812285 - MONOJECT STERILE CORVAC BLOOD TUBE K812285 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sherwood Medical Co.. Cleared Aug 1981. https://www.510kdatabase.net/k812290/ 1981-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k812290-fun-uv-system-pack-test-fda-510k.jpg K812290 - FUN-UV SYSTEM PACK TEST K812290 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Aug 1981. https://www.510kdatabase.net/k812308/ 1981-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k812308-lancer-bun-rate-reagent-kit-fda-510k.jpg K812308 - LANCER BUN RATE REAGENT KIT K812308 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sherwood Medical Co.. Cleared Aug 1981. https://www.510kdatabase.net/k811482/ 1981-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k811482-incontinent-pad-fda-510k.jpg K811482 - INCONTINENT PAD K811482 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Aug 1981. https://www.510kdatabase.net/k811510/ 1981-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k811510-gore-tex-vasular-graft-fda-510k.jpg K811510 - GORE-TEX VASULAR GRAFT K811510 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Aug 1981. https://www.510kdatabase.net/k812114/ 1981-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k812114-lifecare-1000-controller-fda-510k.jpg K812114 - LIFECARE 1000 CONTROLLER K812114 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1981. https://www.510kdatabase.net/k812140/ 1981-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k812140-bird-mean-airway-pressure-monitor-fda-510k.jpg K812140 - BIRD MEAN AIRWAY PRESSURE MONITOR K812140 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: 3M Company. Cleared Aug 1981. https://www.510kdatabase.net/k812154/ 1981-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k812154-medtronic-3484-pisces-epidural-lead-fda-510k.jpg K812154 - MEDTRONIC #3484 PISCES EPIDURAL LEAD K812154 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Aug 1981. https://www.510kdatabase.net/k812195/ 1981-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k812195-emit-st-cannabinoid-assay-fda-510k.jpg K812195 - EMIT-ST CANNABINOID ASSAY K812195 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Aug 1981. https://www.510kdatabase.net/k812196/ 1981-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k812196-emit-st-cannabinoid-controls-fda-510k.jpg K812196 - EMIT-ST CANNABINOID CONTROLS K812196 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Aug 1981. https://www.510kdatabase.net/k812197/ 1981-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k812197-emit-st-cannabinoid-calibrator-fda-510k.jpg K812197 - EMIT-ST CANNABINOID CALIBRATOR K812197 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Aug 1981. https://www.510kdatabase.net/k812231/ 1981-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k812231-intravenous-administration-set-fda-510k.jpg K812231 - INTRAVENOUS ADMINISTRATION SET K812231 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cordis Corp.. Cleared Aug 1981. https://www.510kdatabase.net/k812246/ 1981-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k812246-coat-a-count-t3-ria-kit-fda-510k.jpg K812246 - COAT-A-COUNT T3 RIA KIT K812246 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Aug 1981. https://www.510kdatabase.net/k812255/ 1981-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k812255-ethicon-lacrimal-stent-fda-510k.jpg K812255 - ETHICON LACRIMAL STENT K812255 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Ethicon, Inc.. Cleared Aug 1981. https://www.510kdatabase.net/k811426/ 1981-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k811426-articulated-arm-b-scanner-fda-510k.jpg K811426 - ARTICULATED ARM B-SCANNER K811426 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Aug 1981. https://www.510kdatabase.net/k812077/ 1981-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k812077-helena-sickle-thal-quik-column-method-fda-510k.jpg K812077 - HELENA SICKLE-THAL QUIK COLUMN METHOD K812077 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Aug 1981. https://www.510kdatabase.net/k812101/ 1981-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k812101-bak-on-sp-porcelain-alloy-fda-510k.jpg K812101 - BAK-ON SP PORCELAIN ALLOY K812101 is a FDA 510(k) cleared dental medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Aug 1981. https://www.510kdatabase.net/k812182/ 1981-08-18 monthly 0.5 https://www.510kdatabase.net/og-image/k812182-miami-protrusio-ring-fda-510k.jpg K812182 - MIAMI, PROTRUSIO RING K812182 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Aug 1981. https://www.510kdatabase.net/k811637/ 1981-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k811637-rubella-latex-card-test-fda-510k.jpg K811637 - RUBELLA LATEX CARD TEST K811637 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1981. https://www.510kdatabase.net/k811920/ 1981-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k811920-adaptaid-lead-adapter-365-17-fda-510k.jpg K811920 - ADAPTAID LEAD ADAPTER, #365-17 K811920 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Aug 1981. https://www.510kdatabase.net/k811934/ 1981-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k811934-dss-500-fda-510k.jpg K811934 - DSS 500 K811934 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Aug 1981. https://www.510kdatabase.net/k811967/ 1981-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k811967-cp-625-see-thru-film-changer-fda-510k.jpg K811967 - CP-625 SEE-THRU FILM CHANGER K811967 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Aug 1981. https://www.510kdatabase.net/k811969/ 1981-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k811969-dual-pedestal-table-fda-510k.jpg K811969 - DUAL PEDESTAL TABLE K811969 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Aug 1981. https://www.510kdatabase.net/k811970/ 1981-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k811970-ap-x-ray-tube-angulation-device-fda-510k.jpg K811970 - AP X-RAY TUBE ANGULATION DEVICE K811970 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Aug 1981. https://www.510kdatabase.net/k811971/ 1981-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k811971-cordis-ducor-ptr-system-fda-510k.jpg K811971 - CORDIS DUCOR PTR SYSTEM K811971 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Aug 1981. https://www.510kdatabase.net/k812082/ 1981-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k812082-kanamycin-disk-fda-510k.jpg K812082 - KANAMYCIN DISK K812082 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Aug 1981. https://www.510kdatabase.net/k812083/ 1981-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k812083-bile-disk-fda-510k.jpg K812083 - BILE DISK K812083 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Aug 1981. https://www.510kdatabase.net/k812084/ 1981-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k812084-sps-disk-fda-510k.jpg K812084 - SPS DISK K812084 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Aug 1981. https://www.510kdatabase.net/k812129/ 1981-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k812129-coat-a-count-digitoxin-ria-kit-fda-510k.jpg K812129 - COAT-A-COUNT DIGITOXIN RIA KIT K812129 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Aug 1981. https://www.510kdatabase.net/k810414/ 1981-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k810414-usci-doppler-catheter-system-fda-510k.jpg K810414 - USCI DOPPLER CATHETER SYSTEM K810414 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Aug 1981. https://www.510kdatabase.net/k811416/ 1981-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k811416-moore-hip-prosthesis-pmma-coated-fda-510k.jpg K811416 - MOORE HIP PROSTHESIS, PMMA COATED K811416 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Aug 1981. https://www.510kdatabase.net/k811872/ 1981-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k811872-teflon-pledget-suture-buttress-fda-510k.jpg K811872 - TEFLON PLEDGET SUTURE BUTTRESS K811872 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ethicon, Inc.. Cleared Aug 1981. https://www.510kdatabase.net/k811978/ 1981-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k811978-technicon-h6000-90hr-hematology-sys-fda-510k.jpg K811978 - TECHNICON H6000 (90/HR) HEMATOLOGY SYS K811978 is a FDA 510(k) cleared hematology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Aug 1981. https://www.510kdatabase.net/k812100/ 1981-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k812100-seralyzer-fda-510k.jpg K812100 - SERALYZER K812100 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Aug 1981. https://www.510kdatabase.net/k811938/ 1981-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k811938-adaptaid-lead-adapter-365-25-fda-510k.jpg K811938 - ADAPTAID LEAD ADAPTER #365-25 K811938 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Aug 1981. https://www.510kdatabase.net/k810459/ 1981-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k810459-three-level-control-sera-fda-510k.jpg K810459 - THREE LEVEL CONTROL SERA K810459 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1981. https://www.510kdatabase.net/k811372/ 1981-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k811372-model-84-transport-system-fda-510k.jpg K811372 - MODEL 84 TRANSPORT SYSTEM K811372 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Aug 1981. https://www.510kdatabase.net/k812027/ 1981-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k812027-kodak-ektachem-clin-chem-slides-amyl-fda-510k.jpg K812027 - KODAK EKTACHEM CLIN. CHEM. SLIDES (AMYL) K812027 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Aug 1981. https://www.510kdatabase.net/k812028/ 1981-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k812028-kodak-ektachem-clin-chem-slides-tp-fda-510k.jpg K812028 - KODAK EKTACHEM CLIN. CHEM. SLIDES (TP) K812028 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Aug 1981. https://www.510kdatabase.net/k812029/ 1981-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k812029-kodak-ektachem-clin-chem-slides-trig-fda-510k.jpg K812029 - KODAK EKTACHEM CLIN. CHEM. SLIDES (TRIG) K812029 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Aug 1981. https://www.510kdatabase.net/k812030/ 1981-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k812030-kodak-ektachem-clin-chem-slides-alb-fda-510k.jpg K812030 - KODAK EKTACHEM CLIN. CHEM. SLIDES (ALB) K812030 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Aug 1981. https://www.510kdatabase.net/k811864/ 1981-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k811864-sigma-procedure-265-uv-fda-510k.jpg K811864 - SIGMA PROCEDURE 265-UV K811864 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Jul 1981. https://www.510kdatabase.net/k811892/ 1981-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k811892-cordis-dow-sera-flo-tm-transducer-prot-fda-510k.jpg K811892 - CORDIS DOW SERA FLO TM TRANSDUCER PROT K811892 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Jul 1981. https://www.510kdatabase.net/k811937/ 1981-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k811937-argyle-tartan-tracheal-tube-fda-510k.jpg K811937 - ARGYLE TARTAN TRACHEAL TUBE K811937 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sherwood Medical Co.. Cleared Jul 1981. https://www.510kdatabase.net/k811911/ 1981-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k811911-single-channel-non-fade-oscilloscope-fda-510k.jpg K811911 - SINGLE CHANNEL NON-FADE OSCILLOSCOPE K811911 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Jul 1981. https://www.510kdatabase.net/k812004/ 1981-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k812004-gastrin-ria-diagnostic-kit-fda-510k.jpg K812004 - GASTRIN RIA DIAGNOSTIC KIT K812004 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jul 1981. https://www.510kdatabase.net/k812023/ 1981-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k812023-monoject-sterile-m506-6cc-syringes-fda-510k.jpg K812023 - MONOJECT STERILE M506 6CC SYRINGES K812023 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Jul 1981. https://www.510kdatabase.net/k811784/ 1981-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k811784-sigma-procedure-890-fda-510k.jpg K811784 - SIGMA PROCEDURE #890 K811784 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Sigma Chemical Co.. Cleared Jul 1981. https://www.510kdatabase.net/k812003/ 1981-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k812003-a-gent-theophylline-fda-510k.jpg K812003 - A-GENT THEOPHYLLINE K812003 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jul 1981. https://www.510kdatabase.net/k811258/ 1981-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k811258-base-metal-alloy-fda-510k.jpg K811258 - BASE METAL ALLOY K811258 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jul 1981. https://www.510kdatabase.net/k811912/ 1981-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k811912-helena-vma-smc-control-fda-510k.jpg K811912 - HELENA VMA-SMC CONTROL K811912 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Jul 1981. https://www.510kdatabase.net/k811919/ 1981-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k811919-kodak-ektachem-400-analyzer-fda-510k.jpg K811919 - KODAK EKTACHEM 400 ANALYZER K811919 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Jul 1981. https://www.510kdatabase.net/k811921/ 1981-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k811921-hitachi-705-calibrator-fda-510k.jpg K811921 - HITACHI 705 CALIBRATOR K811921 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jul 1981. https://www.510kdatabase.net/k811932/ 1981-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k811932-coat-a-count-digoxin-ria-fda-510k.jpg K811932 - COAT-A-COUNT DIGOXIN RIA K811932 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jul 1981. https://www.510kdatabase.net/k811957/ 1981-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k811957-campypak-fda-510k.jpg K811957 - CAMPYPAK K811957 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jul 1981. https://www.510kdatabase.net/k812078/ 1981-07-23 monthly 0.5 https://www.510kdatabase.net/og-image/k812078-gonozyme-10-copies-frwd-worig-to-bg-fda-510k.jpg K812078 - GONOZYME (10 COPIES FRWD. W/ORIG. TO BG) K812078 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Jul 1981. https://www.510kdatabase.net/k811318/ 1981-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k811318-temporary-endocardial-tripolar-ld-6880-fda-510k.jpg K811318 - TEMPORARY ENDOCARDIAL TRIPOLAR LD. #6880 K811318 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jul 1981. https://www.510kdatabase.net/k811557/ 1981-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k811557-depuy-hemodrain-fda-510k.jpg K811557 - DEPUY HEMODRAIN K811557 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Depuy, Inc.. Cleared Jul 1981. https://www.510kdatabase.net/k811691/ 1981-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k811691-cordis-omni-articor-cardiac-pacer-308-fda-510k.jpg K811691 - CORDIS OMNI-ARTICOR CARDIAC PACER #308 K811691 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Jul 1981. https://www.510kdatabase.net/k811738/ 1981-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k811738-collarless-tapered-stem-hip-prosth-dev-fda-510k.jpg K811738 - COLLARLESS TAPERED STEM HIP PROSTH. DEV K811738 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jul 1981. https://www.510kdatabase.net/k811754/ 1981-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k811754-crystona-fda-510k.jpg K811754 - CRYSTONA K811754 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Jul 1981. https://www.510kdatabase.net/k811983/ 1981-07-20 monthly 0.5 https://www.510kdatabase.net/og-image/k811983-johnson-johnson-ob-tampons-fda-510k.jpg K811983 - JOHNSON & JOHNSON O.B. TAMPONS K811983 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jul 1981. https://www.510kdatabase.net/k810569/ 1981-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k810569-contact-micro-colpohysteroscope-fda-510k.jpg K810569 - CONTACT-MICRO COLPOHYSTEROSCOPE K810569 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Jul 1981. https://www.510kdatabase.net/k811589/ 1981-07-16 monthly 0.5 https://www.510kdatabase.net/og-image/k811589-actin-fs-activated-ptt-reagent-fda-510k.jpg K811589 - ACTIN FS ACTIVATED PTT REAGENT K811589 is a FDA 510(k) cleared hematology medical device. Manufacturer: American Dade. Cleared Jul 1981. https://www.510kdatabase.net/k811692/ 1981-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k811692-gentamicin-reagent-test-kit-fda-510k.jpg K811692 - GENTAMICIN REAGENT TEST KIT K811692 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jul 1981. https://www.510kdatabase.net/k811710/ 1981-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k811710-biorad-hemoglobin-a1-by-column-test-fda-510k.jpg K811710 - BIO.RAD HEMOGLOBIN A1 BY COLUMN TEST K811710 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bio-Rad. Cleared Jul 1981. https://www.510kdatabase.net/k811832/ 1981-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k811832-precinorm-u-precipath-u-human-serum-fda-510k.jpg K811832 - PRECINORM U & PRECIPATH U HUMAN SERUM K811832 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jul 1981. https://www.510kdatabase.net/k811952/ 1981-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k811952-ames-tda-carbamazepine-test-fda-510k.jpg K811952 - AMES TDA CARBAMAZEPINE TEST K811952 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Jul 1981. https://www.510kdatabase.net/k811069/ 1981-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k811069-fibrinogen-control-plasma-fda-510k.jpg K811069 - FIBRINOGEN CONTROL PLASMA K811069 is a FDA 510(k) cleared hematology medical device. Manufacturer: American Dade. Cleared Jul 1981. https://www.510kdatabase.net/k811227/ 1981-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k811227-ctt-datalink-b7875-aab7875-ab-fda-510k.jpg K811227 - CT/T DATALINK-B7875 AA/B7875 AB K811227 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jul 1981. https://www.510kdatabase.net/k811421/ 1981-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k811421-hcg-radioimmunoassay-kit-125i-fda-510k.jpg K811421 - HCG RADIOIMMUNOASSAY KIT (125I) K811421 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jul 1981. https://www.510kdatabase.net/k811591/ 1981-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k811591-b-d-drake-willock-7000-series-ultraf-fda-510k.jpg K811591 - B-D DRAKE WILLOCK #7000 SERIES ULTRAF K811591 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jul 1981. https://www.510kdatabase.net/k811638/ 1981-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k811638-datascope-internal-defibrillator-paddles-fda-510k.jpg K811638 - DATASCOPE INTERNAL DEFIBRILLATOR PADDLES K811638 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Jul 1981. https://www.510kdatabase.net/k811670/ 1981-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k811670-steri-lok-dual-purpose-packaging8400-fda-510k.jpg K811670 - STERI-LOK DUAL PURPOSE PACKAGING/8400 K811670 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Jul 1981. https://www.510kdatabase.net/k811709/ 1981-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k811709-quantimune-estriol-ria-fda-510k.jpg K811709 - QUANTIMUNE ESTRIOL RIA K811709 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Jul 1981. https://www.510kdatabase.net/k811724/ 1981-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k811724-2m-9810-microwave-oven-fda-510k.jpg K811724 - 2M 9810 MICROWAVE OVEN K811724 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Jul 1981. https://www.510kdatabase.net/k811770/ 1981-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k811770-emit-cad-procainamide-assay-fda-510k.jpg K811770 - EMIT-CAD PROCAINAMIDE ASSAY K811770 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jul 1981. https://www.510kdatabase.net/k811787/ 1981-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k811787-quantaphase-t-4-ria-fda-510k.jpg K811787 - QUANTAPHASE T-4 RIA K811787 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Jul 1981. https://www.510kdatabase.net/k811844/ 1981-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k811844-coat-a-count-gentamicin-ria-kit-fda-510k.jpg K811844 - COAT-A-COUNT GENTAMICIN RIA KIT K811844 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jul 1981. https://www.510kdatabase.net/k811856/ 1981-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k811856-fluoromatic-theophylline-fia-fda-510k.jpg K811856 - FLUOROMATIC THEOPHYLLINE FIA K811856 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Jul 1981. https://www.510kdatabase.net/k811078/ 1981-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k811078-radiation-sterilized-admin-set-fda-510k.jpg K811078 - RADIATION STERILIZED ADMIN. SET K811078 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Jul 1981. https://www.510kdatabase.net/k811216/ 1981-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k811216-resident-bedside-monitor-fda-510k.jpg K811216 - RESIDENT BEDSIDE MONITOR K811216 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Laboratories. Cleared Jul 1981. https://www.510kdatabase.net/k811648/ 1981-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k811648-endo-agar-fda-510k.jpg K811648 - ENDO AGAR K811648 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Jul 1981. https://www.510kdatabase.net/k811649/ 1981-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k811649-gelysate-fda-510k.jpg K811649 - GELYSATE K811649 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Jul 1981. https://www.510kdatabase.net/k811650/ 1981-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k811650-macconkey-broth-fda-510k.jpg K811650 - MACCONKEY BROTH K811650 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Jul 1981. https://www.510kdatabase.net/k811651/ 1981-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k811651-trypticase-fda-510k.jpg K811651 - TRYPTICASE K811651 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Jul 1981. https://www.510kdatabase.net/k811652/ 1981-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k811652-polypeptone-peptone-fda-510k.jpg K811652 - POLYPEPTONE PEPTONE K811652 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Jul 1981. https://www.510kdatabase.net/k811653/ 1981-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k811653-phytone-fda-510k.jpg K811653 - PHYTONE K811653 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Jul 1981. https://www.510kdatabase.net/k811654/ 1981-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k811654-brain-heart-infusion-agar-fda-510k.jpg K811654 - BRAIN HEART INFUSION AGAR K811654 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Jul 1981. https://www.510kdatabase.net/k811676/ 1981-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k811676-maxi-camerad-fda-510k.jpg K811676 - MAXI CAMERA/D K811676 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jul 1981. https://www.510kdatabase.net/k811729/ 1981-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k811729-columbia-fda-510k.jpg K811729 - COLUMBIA K811729 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Jul 1981. https://www.510kdatabase.net/k811730/ 1981-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k811730-biosate-fda-510k.jpg K811730 - BIOSATE K811730 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Jul 1981. https://www.510kdatabase.net/k811731/ 1981-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k811731-dextrose-broth-fda-510k.jpg K811731 - DEXTROSE BROTH K811731 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Jul 1981. https://www.510kdatabase.net/k811732/ 1981-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k811732-thiotone-peptone-fda-510k.jpg K811732 - THIOTONE PEPTONE K811732 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Jul 1981. https://www.510kdatabase.net/k811733/ 1981-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k811733-azide-blood-agar-base-fda-510k.jpg K811733 - AZIDE BLOOD AGAR BASE K811733 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Jul 1981. https://www.510kdatabase.net/k811734/ 1981-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k811734-brucella-broth-fda-510k.jpg K811734 - BRUCELLA BROTH K811734 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Jul 1981. https://www.510kdatabase.net/k811735/ 1981-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k811735-cta-medium-fda-510k.jpg K811735 - CTA MEDIUM K811735 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Jul 1981. https://www.510kdatabase.net/k811736/ 1981-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k811736-dcls-agar-fda-510k.jpg K811736 - DCLS AGAR K811736 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Jul 1981. https://www.510kdatabase.net/k811777/ 1981-07-02 monthly 0.5 https://www.510kdatabase.net/og-image/k811777-helena-plasminogen-quiplate-procedure-fda-510k.jpg K811777 - HELENA PLASMINOGEN QUIPLATE PROCEDURE K811777 is a FDA 510(k) cleared immunology medical device. Manufacturer: Helena Laboratories. Cleared Jul 1981. https://www.510kdatabase.net/k811350/ 1981-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k811350-unipolar-spectrax-impl-pulse-generat-fda-510k.jpg K811350 - UNIPOLAR SPECTRAX IMPL. PULSE GENERAT. K811350 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jul 1981. https://www.510kdatabase.net/k811539/ 1981-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k811539-cordis-encor-pewenous-ventricular-bipol-fda-510k.jpg K811539 - CORDIS ENCOR PEWENOUS VENTRICULAR BIPOL K811539 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Jul 1981. https://www.510kdatabase.net/k811630/ 1981-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k811630-kinematic-rotating-hinge-total-knee-pr-fda-510k.jpg K811630 - KINEMATIC ROTATING HINGE TOTAL KNEE PR. K811630 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jul 1981. https://www.510kdatabase.net/k811655/ 1981-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k811655-myelostat-dorsal-cord-stimulator-fda-510k.jpg K811655 - MYELOSTAT DORSAL CORD STIMULATOR K811655 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Jul 1981. https://www.510kdatabase.net/k811695/ 1981-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k811695-helena-fetal-tek-200-marker-fda-510k.jpg K811695 - HELENA FETAL-TEK 200 MARKER K811695 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Jul 1981. https://www.510kdatabase.net/k811696/ 1981-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k811696-il-781-semi-automated-loader-fda-510k.jpg K811696 - IL #781, SEMI-AUTOMATED LOADER K811696 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jul 1981. https://www.510kdatabase.net/k811349/ 1981-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k811349-model-5866-24-lead-adaptor-kit-fda-510k.jpg K811349 - MODEL 5866-24 LEAD ADAPTOR KIT K811349 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jun 1981. https://www.510kdatabase.net/k811512/ 1981-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k811512-teletrace-telephone-ekg-system-fda-510k.jpg K811512 - TELETRACE TELEPHONE EKG SYSTEM K811512 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jun 1981. https://www.510kdatabase.net/k811198/ 1981-06-29 monthly 0.5 https://www.510kdatabase.net/og-image/k811198-ecco-generator-fda-510k.jpg K811198 - ECCO GENERATOR K811198 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Jun 1981. https://www.510kdatabase.net/k811434/ 1981-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k811434-sceptor-id-gram-negative-micid-panels-fda-510k.jpg K811434 - SCEPTOR ID GRAM NEGATIVE MIC/ID PANELS K811434 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jun 1981. https://www.510kdatabase.net/k811447/ 1981-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k811447-shiley-disposable-cannula-trach-tube-fda-510k.jpg K811447 - SHILEY DISPOSABLE CANNULA TRACH. TUBE K811447 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shiley, Inc.. Cleared Jun 1981. https://www.510kdatabase.net/k811588/ 1981-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k811588-helena-fetal-tek-200-method-fda-510k.jpg K811588 - HELENA FETAL-TEK 200 METHOD K811588 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Jun 1981. https://www.510kdatabase.net/k811596/ 1981-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k811596-zimmer-arthroscopy-system-fda-510k.jpg K811596 - ZIMMER ARTHROSCOPY SYSTEM K811596 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jun 1981. https://www.510kdatabase.net/k811618/ 1981-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k811618-emit-cad-procainamiden-acetyl-control-fda-510k.jpg K811618 - EMIT-CAD PROCAINAMIDE/N-ACETYL. CONTROL K811618 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jun 1981. https://www.510kdatabase.net/k811619/ 1981-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k811619-emit-st-serum-phenobarbital-controls-fda-510k.jpg K811619 - EMIT-ST SERUM PHENOBARBITAL CONTROLS K811619 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jun 1981. https://www.510kdatabase.net/k811620/ 1981-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k811620-emit-tox-serum-calibrators-fda-510k.jpg K811620 - EMIT-TOX SERUM CALIBRATORS K811620 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jun 1981. https://www.510kdatabase.net/k811621/ 1981-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k811621-emit-st-serum-phenobarbital-assay-fda-510k.jpg K811621 - EMIT-ST SERUM PHENOBARBITAL ASSAY K811621 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jun 1981. https://www.510kdatabase.net/k811622/ 1981-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k811622-emit-st-serum-phenobarbital-calibrator-fda-510k.jpg K811622 - EMIT-ST SERUM PHENOBARBITAL CALIBRATOR K811622 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jun 1981. https://www.510kdatabase.net/k811675/ 1981-06-25 monthly 0.5 https://www.510kdatabase.net/og-image/k811675-surgical-instruments-for-use-wzimmer-fda-510k.jpg K811675 - SURGICAL INSTRUMENTS FOR USE W/ZIMMER K811675 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jun 1981. https://www.510kdatabase.net/k810999/ 1981-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k810999-cordis-tcpo2-trancutaneous-oxygen-press-fda-510k.jpg K810999 - CORDIS TCPO2 TRANCUTANEOUS OXYGEN PRESS K810999 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Cordis Corp.. Cleared Jun 1981. https://www.510kdatabase.net/k811293/ 1981-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k811293-eftekhar-centralizing-plug-fda-510k.jpg K811293 - EFTEKHAR CENTRALIZING PLUG K811293 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jun 1981. https://www.510kdatabase.net/k811295/ 1981-06-23 monthly 0.5 https://www.510kdatabase.net/og-image/k811295-digital-noise-reducer-fda-510k.jpg K811295 - DIGITAL NOISE REDUCER K811295 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Jun 1981. https://www.510kdatabase.net/k810748/ 1981-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k810748-75-mhz-wp-transducer-fda-510k.jpg K810748 - 7.5 MHZ WP TRANSDUCER K810748 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jun 1981. https://www.510kdatabase.net/k810893/ 1981-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k810893-hewlett-packard-ventilator-fda-510k.jpg K810893 - HEWLETT-PACKARD VENTILATOR K810893 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Jun 1981. https://www.510kdatabase.net/k811266/ 1981-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k811266-quinton-catheter-finger-grip-fda-510k.jpg K811266 - QUINTON CATHETER FINGER GRIP K811266 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quinton, Inc.. Cleared Jun 1981. https://www.510kdatabase.net/k811500/ 1981-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k811500-colbalt-alloy-orthopaedic-wire-fda-510k.jpg K811500 - COLBALT ALLOY ORTHOPAEDIC WIRE K811500 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Jun 1981. https://www.510kdatabase.net/k811505/ 1981-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k811505-monoject-sterile-m503-3cc-syringes-fda-510k.jpg K811505 - MONOJECT STERILE M503 3CC SYRINGES K811505 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Jun 1981. https://www.510kdatabase.net/k811553/ 1981-06-18 monthly 0.5 https://www.510kdatabase.net/og-image/k811553-reagent-set-triglycerides-fda-510k.jpg K811553 - REAGENT SET TRIGLYCERIDES K811553 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jun 1981. https://www.510kdatabase.net/k811382/ 1981-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k811382-lab-tek-jembec-gc-culture-system-fda-510k.jpg K811382 - LAB-TEK JEMBEC G.C. CULTURE SYSTEM K811382 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Jun 1981. https://www.510kdatabase.net/k811443/ 1981-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k811443-enhance-dental-restorative-fda-510k.jpg K811443 - ENHANCE DENTAL RESTORATIVE K811443 is a FDA 510(k) cleared dental medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jun 1981. https://www.510kdatabase.net/k811483/ 1981-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k811483-stim-stand-fda-510k.jpg K811483 - STIM STAND K811483 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jun 1981. https://www.510kdatabase.net/k811484/ 1981-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k811484-seating-stools-fda-510k.jpg K811484 - SEATING STOOLS K811484 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jun 1981. https://www.510kdatabase.net/k811485/ 1981-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k811485-walkercrutch-bag-fda-510k.jpg K811485 - WALKER/CRUTCH BAG K811485 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jun 1981. https://www.510kdatabase.net/k811486/ 1981-06-16 monthly 0.5 https://www.510kdatabase.net/og-image/k811486-wheelchair-ramps-fda-510k.jpg K811486 - WHEELCHAIR RAMPS K811486 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jun 1981. https://www.510kdatabase.net/k811005/ 1981-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k811005-corb-tm-counterrotating-biopsy-needle-fda-510k.jpg K811005 - CORB TM COUNTERROTATING BIOPSY NEEDLE K811005 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jun 1981. https://www.510kdatabase.net/k811463/ 1981-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k811463-auto-syringe-micro-volume-extension-set-fda-510k.jpg K811463 - AUTO-SYRINGE MICRO VOLUME EXTENSION SET K811463 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jun 1981. https://www.510kdatabase.net/k811487/ 1981-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k811487-book-holder-fda-510k.jpg K811487 - BOOK HOLDER K811487 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jun 1981. https://www.510kdatabase.net/k811488/ 1981-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k811488-feeding-aid-kit-fda-510k.jpg K811488 - FEEDING AID KIT K811488 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jun 1981. https://www.510kdatabase.net/k811489/ 1981-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k811489-scooter-board-fda-510k.jpg K811489 - SCOOTER BOARD K811489 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jun 1981. https://www.510kdatabase.net/k811490/ 1981-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k811490-forearm-knee-straps-fda-510k.jpg K811490 - FOREARM & KNEE STRAPS K811490 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jun 1981. https://www.510kdatabase.net/k811491/ 1981-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k811491-wheelchair-accessories-fda-510k.jpg K811491 - WHEELCHAIR ACCESSORIES K811491 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jun 1981. https://www.510kdatabase.net/k811492/ 1981-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k811492-dressing-adaptors-fda-510k.jpg K811492 - DRESSING ADAPTORS K811492 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jun 1981. https://www.510kdatabase.net/k811493/ 1981-06-12 monthly 0.5 https://www.510kdatabase.net/og-image/k811493-crutch-walker-pads-fda-510k.jpg K811493 - CRUTCH & WALKER PADS K811493 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jun 1981. https://www.510kdatabase.net/k811103/ 1981-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k811103-ge-900-fda-510k.jpg K811103 - GE 900 K811103 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jun 1981. https://www.510kdatabase.net/k811379/ 1981-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k811379-shiley-arterial-filter-fda-510k.jpg K811379 - SHILEY ARTERIAL FILTER K811379 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Jun 1981. https://www.510kdatabase.net/k811431/ 1981-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k811431-technicon-star-system-fda-510k.jpg K811431 - TECHNICON STAR SYSTEM K811431 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Jun 1981. https://www.510kdatabase.net/k811459/ 1981-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k811459-emit-and-methotrexate-assay-fda-510k.jpg K811459 - EMIT-AND METHOTREXATE ASSAY K811459 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Jun 1981. https://www.510kdatabase.net/k811460/ 1981-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k811460-emit-cad-quinidine-assay-fda-510k.jpg K811460 - EMIT-CAD QUINIDINE ASSAY K811460 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jun 1981. https://www.510kdatabase.net/k811461/ 1981-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k811461-emit-and-methotrexate-control-fda-510k.jpg K811461 - EMIT-AND METHOTREXATE CONTROL K811461 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jun 1981. https://www.510kdatabase.net/k811462/ 1981-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k811462-emit-cad-quindine-control-fda-510k.jpg K811462 - EMIT-CAD QUINDINE CONTROL K811462 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jun 1981. https://www.510kdatabase.net/k810726/ 1981-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k810726-formulation-change-in-united-skin-barr-fda-510k.jpg K810726 - FORMULATION CHANGE IN UNITED SKIN BARR K810726 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Howmedica Corp.. Cleared Jun 1981. https://www.510kdatabase.net/k811192/ 1981-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k811192-vac-rite-sunction-collection-fda-510k.jpg K811192 - VAC-RITE SUNCTION COLLECTION K811192 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jun 1981. https://www.510kdatabase.net/k811291/ 1981-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k811291-tegaderm-transparent-dressing-fda-510k.jpg K811291 - TEGADERM TRANSPARENT DRESSING K811291 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3M Company. Cleared Jun 1981. https://www.510kdatabase.net/k811409/ 1981-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k811409-argyle-cpap-nasal-cannula-fda-510k.jpg K811409 - ARGYLE CPAP NASAL CANNULA K811409 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sherwood Medical Co.. Cleared Jun 1981. https://www.510kdatabase.net/k810239/ 1981-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k810239-vented-primary-piggyback-venoset-dual-fda-510k.jpg K810239 - VENTED PRIMARY PIGGYBACK VENOSET DUAL K810239 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared May 1981. https://www.510kdatabase.net/k811263/ 1981-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k811263-tox-tm-analyzer-fda-510k.jpg K811263 - TOX TM ANALYZER K811263 is a FDA 510(k) cleared immunology medical device. Manufacturer: Abbott Laboratories. Cleared May 1981. https://www.510kdatabase.net/k811317/ 1981-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k811317-howmedica-femoral-pressuring-seal-fda-510k.jpg K811317 - HOWMEDICA FEMORAL PRESSURING SEAL K811317 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared May 1981. https://www.510kdatabase.net/k811329/ 1981-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k811329-schaedler-broth-fda-510k.jpg K811329 - SCHAEDLER BROTH K811329 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811330/ 1981-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k811330-sim-medium-fda-510k.jpg K811330 - SIM MEDIUM K811330 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811331/ 1981-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k811331-sf-broth-fda-510k.jpg K811331 - SF BROTH K811331 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811332/ 1981-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k811332-brain-heart-cc-agar-fda-510k.jpg K811332 - BRAIN HEART CC AGAR K811332 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811333/ 1981-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k811333-ec-medium-fda-510k.jpg K811333 - EC MEDIUM K811333 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811334/ 1981-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k811334-mycosel-fda-510k.jpg K811334 - MYCOSEL K811334 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811335/ 1981-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k811335-thioglycollate-gelatin-medium-fda-510k.jpg K811335 - THIOGLYCOLLATE GELATIN MEDIUM K811335 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811336/ 1981-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k811336-m-green-yeast-mold-broth-fda-510k.jpg K811336 - M-GREEN YEAST & MOLD BROTH K811336 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811337/ 1981-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k811337-tergitol-7-agar-fda-510k.jpg K811337 - TERGITOL 7 AGAR K811337 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811338/ 1981-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k811338-violet-red-bile-agar-fda-510k.jpg K811338 - VIOLET RED BILE AGAR K811338 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811339/ 1981-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k811339-todd-hewitt-broth-fda-510k.jpg K811339 - TODD HEWITT BROTH K811339 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811340/ 1981-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k811340-thioglycollate-medium-wout-indicator-fda-510k.jpg K811340 - THIOGLYCOLLATE MEDIUM W/OUT INDICATOR K811340 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811353/ 1981-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k811353-brain-heart-infusion-wo-dextrose-fda-510k.jpg K811353 - BRAIN HEART INFUSION W/O DEXTROSE K811353 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811354/ 1981-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k811354-gn-broth-hajna-fda-510k.jpg K811354 - GN BROTH (HAJNA) K811354 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811355/ 1981-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k811355-lysine-iron-agar-fda-510k.jpg K811355 - LYSINE IRON AGAR K811355 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811356/ 1981-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k811356-tryptone-azolecithin-tween-fda-510k.jpg K811356 - TRYPTONE AZOLECITHIN TWEEN K811356 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811357/ 1981-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k811357-hemoglobin-powder-fda-510k.jpg K811357 - HEMOGLOBIN POWDER K811357 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811358/ 1981-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k811358-dehydrated-bile-fda-510k.jpg K811358 - DEHYDRATED BILE K811358 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811359/ 1981-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k811359-agar-bacteriological-fda-510k.jpg K811359 - AGAR, BACTERIOLOGICAL K811359 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811360/ 1981-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k811360-yeast-extract-fda-510k.jpg K811360 - YEAST EXTRACT K811360 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811361/ 1981-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k811361-pancreatic-hydrolysate-of-heart-muscle-fda-510k.jpg K811361 - PANCREATIC HYDROLYSATE OF HEART MUSCLE K811361 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811362/ 1981-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k811362-tcbs-agar-fda-510k.jpg K811362 - TCBS AGAR K811362 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811392/ 1981-05-29 monthly 0.5 https://www.510kdatabase.net/og-image/k811392-ames-sera-pak-glucose-reagent-fda-510k.jpg K811392 - AMES SERA-PAK GLUCOSE REAGENT K811392 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811321/ 1981-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k811321-standard-methods-agar-fda-510k.jpg K811321 - STANDARD METHODS AGAR K811321 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811322/ 1981-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k811322-potato-dextrose-agar-fda-510k.jpg K811322 - POTATO DEXTROSE AGAR K811322 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811323/ 1981-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k811323-nutrient-broth-fda-510k.jpg K811323 - NUTRIENT BROTH K811323 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811324/ 1981-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k811324-phenylethanol-agar-fda-510k.jpg K811324 - PHENYLETHANOL AGAR K811324 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811325/ 1981-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k811325-sabouraud-dextrose-agar-fda-510k.jpg K811325 - SABOURAUD DEXTROSE AGAR K811325 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811326/ 1981-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k811326-sabouraud-liquid-broth-modified-fda-510k.jpg K811326 - SABOURAUD LIQUID, BROTH MODIFIED K811326 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811327/ 1981-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k811327-salmonella-shigella-agar-fda-510k.jpg K811327 - SALMONELLA SHIGELLA AGAR K811327 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811328/ 1981-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k811328-schaedler-agar-fda-510k.jpg K811328 - SCHAEDLER AGAR K811328 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k810317/ 1981-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k810317-nitroglycerine-iv-set-fda-510k.jpg K810317 - NITROGLYCERINE IV SET K810317 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared May 1981. https://www.510kdatabase.net/k810677/ 1981-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k810677-models-59765977-pacemaker-pulse-gener-fda-510k.jpg K810677 - MODELS 5976/5977 PACEMAKER PULSE GENER K810677 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811106/ 1981-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k811106-intermedics-poly-flex-endocardial-pacing-fda-510k.jpg K811106 - INTERMEDICS POLY FLEX ENDOCARDIAL PACING K811106 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811123/ 1981-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k811123-medtronic-pulse-generator-fda-510k.jpg K811123 - MEDTRONIC PULSE GENERATOR K811123 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared May 1981. https://www.510kdatabase.net/k811187/ 1981-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k811187-medtronic-a2-clinical-imaging-system-fda-510k.jpg K811187 - MEDTRONIC A2 CLINICAL IMAGING SYSTEM K811187 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medtronic Vascular. Cleared May 1981. https://www.510kdatabase.net/k811194/ 1981-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k811194-hitachi-705-automatic-blood-chemistry-fda-510k.jpg K811194 - HITACHI 705 AUTOMATIC BLOOD CHEMISTRY K811194 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared May 1981. https://www.510kdatabase.net/k811221/ 1981-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k811221-intermedics-cyberlith-bipolar-cardiac-fda-510k.jpg K811221 - INTERMEDICS CYBERLITH BIPOLAR CARDIAC K811221 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811273/ 1981-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k811273-cyclic-amp-radioimmunoassay-kit-125i-fda-510k.jpg K811273 - CYCLIC AMP RADIOIMMUNOASSAY KIT [125I] K811273 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared May 1981. https://www.510kdatabase.net/k811274/ 1981-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k811274-prostatic-acid-phosphatase-radioimm-kit-fda-510k.jpg K811274 - PROSTATIC ACID PHOSPHATASE RADIOIMM. KIT K811274 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared May 1981. https://www.510kdatabase.net/k811315/ 1981-05-27 monthly 0.5 https://www.510kdatabase.net/og-image/k811315-coat-a-count-t4-ria-kit-fda-510k.jpg K811315 - COAT-A-COUNT T4 RIA KIT K811315 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared May 1981. https://www.510kdatabase.net/k810973/ 1981-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k810973-system-400-fda-510k.jpg K810973 - SYSTEM 400 K810973 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared May 1981. https://www.510kdatabase.net/k811201/ 1981-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k811201-eftekhar-acetabular-standoff-fda-510k.jpg K811201 - EFTEKHAR ACETABULAR STANDOFF K811201 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811204/ 1981-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k811204-bronchek-shiley-cardiac-jacket-bsc-j-fda-510k.jpg K811204 - BRONCHEK-SHILEY CARDIAC JACKET & BSC J K811204 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811223/ 1981-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k811223-vasovasostomy-stabilizer-platform-dev-fda-510k.jpg K811223 - VASOVASOSTOMY STABILIZER PLATFORM DEV K811223 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Biomet, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811249/ 1981-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k811249-technicon-smac-ii-system-accessories-fda-510k.jpg K811249 - TECHNICON SMAC II SYSTEM & ACCESSORIES K811249 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared May 1981. https://www.510kdatabase.net/k810734/ 1981-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k810734-models-8420-thru-8423-pacemaker-gener-fda-510k.jpg K810734 - MODELS 8420 THRU 8423 PACEMAKER GENER K810734 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared May 1981. https://www.510kdatabase.net/k811011/ 1981-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k811011-histochemical-demonstration-of-leukocyte-fda-510k.jpg K811011 - HISTOCHEMICAL DEMONSTRATION OF LEUKOCYTE K811011 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Sigma Chemical Co.. Cleared May 1981. https://www.510kdatabase.net/k811144/ 1981-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k811144-aria-ii-insulin-ria-fda-510k.jpg K811144 - ARIA II INSULIN RIA K811144 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared May 1981. https://www.510kdatabase.net/k811151/ 1981-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k811151-collarless-total-hip-femoral-comp-sys-fda-510k.jpg K811151 - COLLARLESS TOTAL HIP FEMORAL COMP. SYS K811151 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared May 1981. https://www.510kdatabase.net/k811152/ 1981-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k811152-dade-rpr-card-test-fda-510k.jpg K811152 - DADE RPR CARD TEST K811152 is a FDA 510(k) cleared microbiology medical device. Manufacturer: American Dade. Cleared May 1981. https://www.510kdatabase.net/k811177/ 1981-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k811177-quanta-phase-vitamin-b-12folate-rad-fda-510k.jpg K811177 - QUANTA PHASE VITAMIN B-12/FOLATE RAD K811177 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared May 1981. https://www.510kdatabase.net/k811033/ 1981-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k811033-shiley-low-pressure-thin-cuffed-trach-fda-510k.jpg K811033 - SHILEY LOW PRESSURE THIN-CUFFED TRACH K811033 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shiley, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811143/ 1981-05-13 monthly 0.5 https://www.510kdatabase.net/og-image/k811143-phblood-gas-control-abc-fda-510k.jpg K811143 - PH/BLOOD GAS CONTROL (ABC) K811143 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared May 1981. https://www.510kdatabase.net/k810638/ 1981-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k810638-lancer-glycosylated-hemoglobin-fda-510k.jpg K810638 - LANCER GLYCOSYLATED HEMOGLOBIN K810638 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sherwood Medical Co.. Cleared May 1981. https://www.510kdatabase.net/k810714/ 1981-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k810714-lancer-glycosylated-hemoglobin-assay-fda-510k.jpg K810714 - LANCER GLYCOSYLATED HEMOGLOBIN ASSAY K810714 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sherwood Medical Co.. Cleared May 1981. https://www.510kdatabase.net/k810297/ 1981-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k810297-datascope-percordl-dual-lumen-intra-fda-510k.jpg K810297 - DATASCOPE PERCOR=DL DUAL-LUMEN INTRA K810297 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared May 1981. https://www.510kdatabase.net/k810835/ 1981-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k810835-rubazyme-m-fda-510k.jpg K810835 - RUBAZYME - M K810835 is a FDA 510(k) cleared immunology medical device. Manufacturer: Abbott Laboratories. Cleared May 1981. https://www.510kdatabase.net/k810899/ 1981-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k810899-technicon-autogrouper-16-c-system-fda-510k.jpg K810899 - TECHNICON AUTOGROUPER 16-C SYSTEM K810899 is a FDA 510(k) cleared hematology medical device. Manufacturer: Technicon Instruments Corp.. Cleared May 1981. https://www.510kdatabase.net/k811023/ 1981-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k811023-root-canal-kit-fda-510k.jpg K811023 - ROOT CANAL KIT K811023 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared May 1981. https://www.510kdatabase.net/k811039/ 1981-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k811039-vogel-johnson-agar-fda-510k.jpg K811039 - VOGEL & JOHNSON AGAR K811039 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811040/ 1981-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k811040-cetrimede-agar-fda-510k.jpg K811040 - CETRIMEDE AGAR K811040 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811041/ 1981-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k811041-brilliant-green-agar-fda-510k.jpg K811041 - BRILLIANT GREEN AGAR K811041 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811042/ 1981-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k811042-xld-agar-fda-510k.jpg K811042 - XLD AGAR K811042 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811043/ 1981-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k811043-bismuth-sulfite-agar-fda-510k.jpg K811043 - BISMUTH SULFITE AGAR K811043 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811044/ 1981-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k811044-triple-sugar-iron-agar-fda-510k.jpg K811044 - TRIPLE SUGAR IRON AGAR K811044 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811045/ 1981-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k811045-levin-eosin-methylene-blue-agar-fda-510k.jpg K811045 - LEVIN EOSIN-METHYLENE BLUE AGAR K811045 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811046/ 1981-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k811046-sterility-test-broth-fda-510k.jpg K811046 - STERILITY TEST BROTH K811046 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811047/ 1981-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k811047-fluid-thioglycollate-medium-fda-510k.jpg K811047 - FLUID THIOGLYCOLLATE MEDIUM K811047 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811048/ 1981-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k811048-macconkey-agar-fda-510k.jpg K811048 - MACCONKEY AGAR K811048 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811055/ 1981-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k811055-blood-agar-base-ph-74-fda-510k.jpg K811055 - BLOOD AGAR BASE PH 7.4 K811055 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811065/ 1981-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k811065-piston-syringe-fda-510k.jpg K811065 - PISTON SYRINGE K811065 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared May 1981. https://www.510kdatabase.net/k811128/ 1981-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k811128-brucella-agar-fda-510k.jpg K811128 - BRUCELLA AGAR K811128 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811129/ 1981-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k811129-lauryl-sulfate-broth-fda-510k.jpg K811129 - LAURYL SULFATE BROTH K811129 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811130/ 1981-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k811130-lactose-broth-fda-510k.jpg K811130 - LACTOSE BROTH K811130 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811131/ 1981-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k811131-hektoen-enteric-agar-fda-510k.jpg K811131 - HEKTOEN ENTERIC AGAR K811131 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811132/ 1981-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k811132-eugon-broth-fda-510k.jpg K811132 - EUGON BROTH K811132 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811133/ 1981-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k811133-eosin-methylene-blue-agar-fda-510k.jpg K811133 - EOSIN-METHYLENE BLUE AGAR K811133 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811134/ 1981-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k811134-acu-desoxycholate-agar-fda-510k.jpg K811134 - ACU-DESOXYCHOLATE AGAR K811134 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811135/ 1981-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k811135-columbia-blood-agar-base-fda-510k.jpg K811135 - COLUMBIA BLOOD AGAR BASE K811135 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811136/ 1981-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k811136-mueller-hinton-broth-fda-510k.jpg K811136 - MUELLER HINTON BROTH K811136 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811137/ 1981-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k811137-columbia-cna-agar-fda-510k.jpg K811137 - COLUMBIA CNA AGAR K811137 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811138/ 1981-05-05 monthly 0.5 https://www.510kdatabase.net/og-image/k811138-nutrient-agar-fda-510k.jpg K811138 - NUTRIENT AGAR K811138 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k810437/ 1981-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k810437-breath-meter-fda-510k.jpg K810437 - BREATH METER K810437 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Fred Sammons, Inc.. Cleared May 1981. https://www.510kdatabase.net/k810752/ 1981-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k810752-thinlith-iii-unipolar-cardiac-pulse-gen-fda-510k.jpg K810752 - THINLITH III UNIPOLAR CARDIAC PULSE GEN. K810752 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared May 1981. https://www.510kdatabase.net/k810800/ 1981-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k810800-model-230-05-cyberlith-i-bipol-pulse-g-fda-510k.jpg K810800 - MODEL 230-05 CYBERLITH I BIPOL. PULSE G. K810800 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared May 1981. https://www.510kdatabase.net/k810847/ 1981-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k810847-pritchard-surface-replacement-elbow-fda-510k.jpg K810847 - PRITCHARD SURFACE REPLACEMENT ELBOW K810847 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811034/ 1981-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k811034-emit-cad-n-acetylprocainamide-assay-fda-510k.jpg K811034 - EMIT-CAD N-ACETYLPROCAINAMIDE ASSAY K811034 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared May 1981. https://www.510kdatabase.net/k811052/ 1981-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k811052-tryptic-soy-agar-wlecithin-tween-80-fda-510k.jpg K811052 - TRYPTIC SOY AGAR W/LECITHIN & TWEEN 80 K811052 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared May 1981. https://www.510kdatabase.net/k811066/ 1981-05-01 monthly 0.5 https://www.510kdatabase.net/og-image/k811066-model-230-06-cyberlith-tm-i-bipolar-in-fda-510k.jpg K811066 - MODEL 230-06 CYBERLITH TM I BIPOLAR IN K811066 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared May 1981. https://www.510kdatabase.net/k810991/ 1981-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k810991-headstrap-fda-510k.jpg K810991 - HEADSTRAP K810991 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Apr 1981. https://www.510kdatabase.net/k810992/ 1981-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k810992-helena-vma-smc-column-method-fda-510k.jpg K810992 - HELENA VMA-SMC COLUMN METHOD K810992 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Apr 1981. https://www.510kdatabase.net/k810994/ 1981-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k810994-ames-tda-tm-phenobarbital-test-fda-510k.jpg K810994 - AMES TDA TM PHENOBARBITAL TEST K810994 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Apr 1981. https://www.510kdatabase.net/k810996/ 1981-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k810996-enternal-pump-set-wintegral-container-fda-510k.jpg K810996 - ENTERNAL PUMP SET W/INTEGRAL CONTAINER K810996 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1981. https://www.510kdatabase.net/k811007/ 1981-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k811007-ames-tda-tm-primidone-test-fda-510k.jpg K811007 - AMES TDA TM PRIMIDONE TEST K811007 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Apr 1981. https://www.510kdatabase.net/k811025/ 1981-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k811025-ames-tda-tm-phenytoin-test-fda-510k.jpg K811025 - AMES TDA TM PHENYTOIN TEST K811025 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Apr 1981. https://www.510kdatabase.net/k811026/ 1981-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k811026-ames-tda-tm-amikacin-test-fda-510k.jpg K811026 - AMES TDA TM AMIKACIN TEST K811026 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Apr 1981. https://www.510kdatabase.net/k811037/ 1981-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k811037-mannital-salt-agar-fda-510k.jpg K811037 - MANNITAL SALT AGAR K811037 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1981. https://www.510kdatabase.net/k811038/ 1981-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k811038-baird-parker-agar-fda-510k.jpg K811038 - BAIRD-PARKER AGAR K811038 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1981. https://www.510kdatabase.net/k811049/ 1981-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k811049-mueller-hinton-agar-fda-510k.jpg K811049 - MUELLER HINTON AGAR K811049 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1981. https://www.510kdatabase.net/k811050/ 1981-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k811050-tryptic-soy-broth-fda-510k.jpg K811050 - TRYPTIC SOY BROTH K811050 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1981. https://www.510kdatabase.net/k811051/ 1981-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k811051-tryptic-soy-agar-fda-510k.jpg K811051 - TRYPTIC SOY AGAR K811051 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1981. https://www.510kdatabase.net/k811053/ 1981-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k811053-gc-agar-fda-510k.jpg K811053 - GC AGAR K811053 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1981. https://www.510kdatabase.net/k811054/ 1981-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k811054-biggy-agar-fda-510k.jpg K811054 - BIGGY AGAR K811054 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1981. https://www.510kdatabase.net/k811056/ 1981-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k811056-brain-heart-infusion-fda-510k.jpg K811056 - BRAIN HEART INFUSION K811056 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1981. https://www.510kdatabase.net/k811057/ 1981-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k811057-brilliant-green-bile-broth-2-fda-510k.jpg K811057 - BRILLIANT GREEN BILE BROTH 2% K811057 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Acumedia Manufacturers, Inc.. Cleared Apr 1981. https://www.510kdatabase.net/k803104/ 1981-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k803104-microwave-oven-2m9810-fda-510k.jpg K803104 - MICROWAVE OVEN 2M9810 K803104 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Apr 1981. https://www.510kdatabase.net/k810310/ 1981-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k810310-k-y-lubricating-jelly-fda-510k.jpg K810310 - K-Y LUBRICATING JELLY K810310 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Apr 1981. https://www.510kdatabase.net/k810855/ 1981-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k810855-interface-20-micron-transfusion-bld-f-fda-510k.jpg K810855 - INTERFACE 20 MICRON TRANSFUSION BLD. F. K810855 is a FDA 510(k) cleared hematology medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1981. https://www.510kdatabase.net/k810470/ 1981-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k810470-shiley-s-100a-adult-blood-oxygenator-fda-510k.jpg K810470 - SHILEY S-100A (ADULT) BLOOD OXYGENATOR K810470 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Apr 1981. https://www.510kdatabase.net/k810749/ 1981-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k810749-5-mhz-transducer-fda-510k.jpg K810749 - 5 MHZ TRANSDUCER K810749 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Apr 1981. https://www.510kdatabase.net/k810812/ 1981-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k810812-draining-wound-mgmt-system-fda-510k.jpg K810812 - DRAINING-WOUND MGMT. SYSTEM K810812 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Apr 1981. https://www.510kdatabase.net/k810849/ 1981-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k810849-cordis-biopsy-forceps-fda-510k.jpg K810849 - CORDIS BIOPSY FORCEPS K810849 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Apr 1981. https://www.510kdatabase.net/k810941/ 1981-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k810941-ames-tda-tobramycin-test-fda-510k.jpg K810941 - AMES TDA TOBRAMYCIN TEST K810941 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Apr 1981. https://www.510kdatabase.net/k810942/ 1981-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k810942-ames-tda-gentamicin-test-fda-510k.jpg K810942 - AMES TDA GENTAMICIN TEST K810942 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Apr 1981. https://www.510kdatabase.net/k810943/ 1981-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k810943-ames-tda-theophylline-test-fda-510k.jpg K810943 - AMES TDA THEOPHYLLINE TEST K810943 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Apr 1981. https://www.510kdatabase.net/k810963/ 1981-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k810963-bio-set-tm-substrate-calibrators-fda-510k.jpg K810963 - BIO SET TM SUBSTRATE CALIBRATORS K810963 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Apr 1981. https://www.510kdatabase.net/k810964/ 1981-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k810964-bio-set-tm-phosphorous-calibrator-fda-510k.jpg K810964 - BIO SET TM PHOSPHOROUS CALIBRATOR K810964 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Apr 1981. https://www.510kdatabase.net/k810797/ 1981-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k810797-low-dose-servochest-fda-510k.jpg K810797 - LOW DOSE SERVOCHEST K810797 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Apr 1981. https://www.510kdatabase.net/k810891/ 1981-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k810891-coat-a-count-cortisol-ria-kit-fda-510k.jpg K810891 - COAT-A-COUNT CORTISOL RIA KIT K810891 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Apr 1981. https://www.510kdatabase.net/k810901/ 1981-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k810901-insulative-coating-for-card-pulse-gen-fda-510k.jpg K810901 - INSULATIVE COATING FOR CARD. PULSE GEN K810901 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Apr 1981. https://www.510kdatabase.net/k810751/ 1981-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k810751-pds-cardiac-calc-softw-progr-a3604af-fda-510k.jpg K810751 - PDS CARDIAC CALC. SOFTW. PROGR. #A3604AF K810751 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: General Electric Co.. Cleared Apr 1981. https://www.510kdatabase.net/k810328/ 1981-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k810328-bio-condylar-tm-knee-fda-510k.jpg K810328 - BIO CONDYLAR TM KNEE K810328 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Apr 1981. https://www.510kdatabase.net/k810329/ 1981-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k810329-depuy-segmentalspinal-system-fda-510k.jpg K810329 - DEPUY SEGMENTALSPINAL SYSTEM K810329 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Apr 1981. https://www.510kdatabase.net/k810657/ 1981-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k810657-temptron-s-68046805-fda-510k.jpg K810657 - TEMPTRON #'S 6804/6805 K810657 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Apr 1981. https://www.510kdatabase.net/k810833/ 1981-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k810833-sorvall-rt6000-refrigerated-tabletop-fda-510k.jpg K810833 - SORVALL RT6000 REFRIGERATED TABLETOP K810833 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Apr 1981. https://www.510kdatabase.net/k810060/ 1981-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k810060-pca-total-knee-stemmed-tibia-prosth-fda-510k.jpg K810060 - P.C.A. TOTAL KNEE STEMMED TIBIA PROSTH K810060 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Apr 1981. https://www.510kdatabase.net/k810798/ 1981-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k810798-technicon-star-system-t3-ria-method-fda-510k.jpg K810798 - TECHNICON STAR SYSTEM T3 RIA METHOD K810798 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Apr 1981. https://www.510kdatabase.net/k810503/ 1981-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k810503-flexible-choledochoscopenephroscope-fda-510k.jpg K810503 - FLEXIBLE CHOLEDOCHOSCOPE/NEPHROSCOPE K810503 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Corp.. Cleared Apr 1981. https://www.510kdatabase.net/k810602/ 1981-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k810602-emit-st-serum-barbiturate-assay-fda-510k.jpg K810602 - EMIT-ST SERUM BARBITURATE ASSAY K810602 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Apr 1981. https://www.510kdatabase.net/k810628/ 1981-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k810628-electrosurgical-cutting-coagulation-fda-510k.jpg K810628 - ELECTROSURGICAL CUTTING & COAGULATION K810628 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intermedics, Inc.. Cleared Apr 1981. https://www.510kdatabase.net/k810647/ 1981-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k810647-shiley-oxygenator-thermistor-probe-fda-510k.jpg K810647 - SHILEY OXYGENATOR THERMISTOR PROBE K810647 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Apr 1981. https://www.510kdatabase.net/k810799/ 1981-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k810799-quantimune-ferritin-irma-fda-510k.jpg K810799 - QUANTIMUNE FERRITIN IRMA K810799 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Apr 1981. https://www.510kdatabase.net/k810383/ 1981-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k810383-intermedics-cyberlith-i-biopolar-cardi-fda-510k.jpg K810383 - INTERMEDICS CYBERLITH I BIOPOLAR CARDI K810383 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Apr 1981. https://www.510kdatabase.net/k810385/ 1981-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k810385-cyberlith-i-pulse-generator-model-253-04-fda-510k.jpg K810385 - CYBERLITH I PULSE GENERATOR MODEL 253-04 K810385 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Apr 1981. https://www.510kdatabase.net/k810794/ 1981-04-01 monthly 0.5 https://www.510kdatabase.net/og-image/k810794-a-gent-urea-nitrogen-fda-510k.jpg K810794 - A-GENT UREA NITROGEN K810794 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1981. https://www.510kdatabase.net/k810564/ 1981-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k810564-cefotaxime-30-mcg-sensi-disc-fda-510k.jpg K810564 - CEFOTAXIME 30 MCG. SENSI-DISC. K810564 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1981. https://www.510kdatabase.net/k810599/ 1981-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k810599-dade-rh-control-reagent-fda-510k.jpg K810599 - DADE RH CONTROL REAGENT K810599 is a FDA 510(k) cleared hematology medical device. Manufacturer: American Dade. Cleared Mar 1981. https://www.510kdatabase.net/k810639/ 1981-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k810639-seralyzer-system-fda-510k.jpg K810639 - SERALYZER SYSTEM K810639 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Mar 1981. https://www.510kdatabase.net/k810658/ 1981-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k810658-rpr-card-test-system-fda-510k.jpg K810658 - RPR CARD TEST SYSTEM K810658 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Mar 1981. https://www.510kdatabase.net/k810664/ 1981-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k810664-isolator-system-fda-510k.jpg K810664 - ISOLATOR SYSTEM K810664 is a FDA 510(k) cleared hematology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Mar 1981. https://www.510kdatabase.net/k810717/ 1981-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k810717-coat-a-count-t3-uptake-kit-fda-510k.jpg K810717 - COAT-A-COUNT T3 UPTAKE KIT K810717 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Mar 1981. https://www.510kdatabase.net/k810113/ 1981-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k810113-terfusion-final-filter-set-fda-510k.jpg K810113 - TERFUSION FINAL FILTER SET K810113 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terumo Medical Corp.. Cleared Mar 1981. https://www.510kdatabase.net/k810661/ 1981-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k810661-cathdamp-fda-510k.jpg K810661 - CATHDAMP K810661 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medline Industries, Inc.. Cleared Mar 1981. https://www.510kdatabase.net/k810750/ 1981-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k810750-pds-cardiac-calc-softw-progr-a3604ae-fda-510k.jpg K810750 - PDS CARDIAC CALC. SOFTW. PROGR. #A3604AE K810750 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: General Electric Co.. Cleared Mar 1981. https://www.510kdatabase.net/k810475/ 1981-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k810475-helena-hemoglobin-f-controls-fda-510k.jpg K810475 - HELENA HEMOGLOBIN F CONTROLS K810475 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Mar 1981. https://www.510kdatabase.net/k810520/ 1981-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k810520-insallburstein-constrained-total-condyl-fda-510k.jpg K810520 - INSALL/BURSTEIN CONSTRAINED TOTAL CONDYL K810520 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Mar 1981. https://www.510kdatabase.net/k810579/ 1981-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k810579-adhesive-iv-catheter-dressing-fda-510k.jpg K810579 - ADHESIVE I.V. CATHETER DRESSING K810579 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Mar 1981. https://www.510kdatabase.net/k810623/ 1981-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k810623-band-aid-kitchen-assortment-fda-510k.jpg K810623 - BAND-AID KITCHEN ASSORTMENT K810623 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Mar 1981. https://www.510kdatabase.net/k810518/ 1981-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k810518-cast-hipped-vitallium-fda-510k.jpg K810518 - CAST HIPPED VITALLIUM K810518 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Mar 1981. https://www.510kdatabase.net/k810530/ 1981-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k810530-peri-patch-glue-mold-fda-510k.jpg K810530 - PERI-PATCH GLUE MOLD K810530 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Quinton, Inc.. Cleared Mar 1981. https://www.510kdatabase.net/k810531/ 1981-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k810531-peri-patch-peritoneal-catheter-extension-fda-510k.jpg K810531 - PERI-PATCH PERITONEAL CATHETER EXTENSION K810531 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Quinton, Inc.. Cleared Mar 1981. https://www.510kdatabase.net/k810587/ 1981-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k810587-emit-tfg-prisma-thyroxine-calibrators-fda-510k.jpg K810587 - EMIT-TFG PRISMA THYROXINE CALIBRATORS K810587 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Mar 1981. https://www.510kdatabase.net/k810595/ 1981-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k810595-silux-restorative-material-enamel-bond-fda-510k.jpg K810595 - SILUX RESTORATIVE MATERIAL & ENAMEL BOND K810595 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Mar 1981. https://www.510kdatabase.net/k810644/ 1981-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k810644-hoffman-hoop-device-fda-510k.jpg K810644 - HOFFMAN HOOP DEVICE K810644 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Mar 1981. https://www.510kdatabase.net/k810712/ 1981-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k810712-electronic-spirometer-model-mfr-8100-fda-510k.jpg K810712 - ELECTRONIC SPIROMETER MODEL MFR-8100 K810712 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Mar 1981. https://www.510kdatabase.net/k810187/ 1981-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k810187-auto-suture-pss-skin-stapling-instrument-fda-510k.jpg K810187 - AUTO SUTURE PSS SKIN STAPLING INSTRUMENT K810187 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Mar 1981. https://www.510kdatabase.net/k810188/ 1981-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k810188-auto-suture-gas-powered-disp-lds-stapl-fda-510k.jpg K810188 - AUTO SUTURE GAS POWERED DISP. LDS STAPL K810188 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Mar 1981. https://www.510kdatabase.net/k810315/ 1981-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k810315-alternate-steriliz-for-cellulose-acet-fda-510k.jpg K810315 - ALTERNATE STERILIZ. FOR CELLULOSE ACET K810315 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Mar 1981. https://www.510kdatabase.net/k810324/ 1981-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k810324-automatic-hemoclip-applier-527700-fda-510k.jpg K810324 - AUTOMATIC HEMOCLIP APPLIER, 527700 K810324 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Mar 1981. https://www.510kdatabase.net/k810331/ 1981-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k810331-duo-tel-fda-510k.jpg K810331 - DUO-TEL K810331 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: General Electric Co.. Cleared Mar 1981. https://www.510kdatabase.net/k810552/ 1981-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k810552-cordis-pacemaker-programmers-255a-256a-fda-510k.jpg K810552 - CORDIS PACEMAKER PROGRAMMERS 255A & 256A K810552 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Mar 1981. https://www.510kdatabase.net/k810580/ 1981-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k810580-scotch-brand-adhesive-tape-fda-510k.jpg K810580 - SCOTCH BRAND ADHESIVE TAPE K810580 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3M Company. Cleared Mar 1981. https://www.510kdatabase.net/k810591/ 1981-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k810591-pact-supplement-fda-510k.jpg K810591 - PACT SUPPLEMENT K810591 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1981. https://www.510kdatabase.net/k810616/ 1981-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k810616-miller-multi-radius-total-knee-fda-510k.jpg K810616 - MILLER MULTI-RADIUS TOTAL KNEE K810616 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Mar 1981. https://www.510kdatabase.net/k803081/ 1981-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k803081-quanticheck-control-plasma-fda-510k.jpg K803081 - QUANTICHECK CONTROL PLASMA K803081 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1981. https://www.510kdatabase.net/k810380/ 1981-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k810380-howmedica-t-iii-g-alloy-fda-510k.jpg K810380 - HOWMEDICA T-III G ALLOY K810380 is a FDA 510(k) cleared dental medical device. Manufacturer: Howmedica Corp.. Cleared Mar 1981. https://www.510kdatabase.net/k810541/ 1981-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k810541-beta-lysin-disk-fda-510k.jpg K810541 - BETA LYSIN DISK K810541 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Mar 1981. https://www.510kdatabase.net/k810563/ 1981-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k810563-quinton-lte-electrode-fda-510k.jpg K810563 - QUINTON LTE ELECTRODE K810563 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Mar 1981. https://www.510kdatabase.net/k810586/ 1981-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k810586-emit-tfg-prisma-thyroxine-assay-fda-510k.jpg K810586 - EMIT-TFG PRISMA THYROXINE ASSAY K810586 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Mar 1981. https://www.510kdatabase.net/k810597/ 1981-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k810597-macro-vue-card-test-fda-510k.jpg K810597 - MACRO-VUE CARD TEST K810597 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1981. https://www.510kdatabase.net/k810601/ 1981-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k810601-emit-st-serum-phencyclidine-assay-fda-510k.jpg K810601 - EMIT-ST SERUM PHENCYCLIDINE ASSAY K810601 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Mar 1981. https://www.510kdatabase.net/k810257/ 1981-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k810257-vessel-tips-sizes-13-18-fda-510k.jpg K810257 - VESSEL TIPS, SIZES 13-18 K810257 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quinton, Inc.. Cleared Mar 1981. https://www.510kdatabase.net/k810305/ 1981-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k810305-datason-db-ultrasound-imaging-system-fda-510k.jpg K810305 - DATASON DB ULTRASOUND IMAGING SYSTEM K810305 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: General Electric Co.. Cleared Mar 1981. https://www.510kdatabase.net/k810333/ 1981-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k810333-temporary-myocardial-pacing-lead6400-fda-510k.jpg K810333 - TEMPORARY MYOCARDIAL PACING LEAD#6400 K810333 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Mar 1981. https://www.510kdatabase.net/k810386/ 1981-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k810386-thinlith-ii-pulse-gneerator-model-227-05-fda-510k.jpg K810386 - THINLITH II PULSE GNEERATOR MODEL 227-05 K810386 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Mar 1981. https://www.510kdatabase.net/k810428/ 1981-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k810428-vicryl-fda-510k.jpg K810428 - VICRYL K810428 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Mar 1981. https://www.510kdatabase.net/k810432/ 1981-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k810432-cordis-pervenous-atrial-lead-fda-510k.jpg K810432 - CORDIS PERVENOUS ATRIAL LEAD K810432 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Mar 1981. https://www.510kdatabase.net/k810535/ 1981-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k810535-mouradian-modified-zickel-humeral-rod-fda-510k.jpg K810535 - MOURADIAN MODIFIED ZICKEL HUMERAL ROD K810535 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Mar 1981. https://www.510kdatabase.net/k810578/ 1981-03-13 monthly 0.5 https://www.510kdatabase.net/og-image/k810578-beckman-theophylline-reagent-test-kit-fda-510k.jpg K810578 - BECKMAN THEOPHYLLINE REAGENT TEST KIT K810578 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Mar 1981. https://www.510kdatabase.net/k810440/ 1981-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k810440-silicone-elbow-bed-and-chair-pads-fda-510k.jpg K810440 - SILICONE ELBOW, BED AND CHAIR PADS K810440 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Mar 1981. https://www.510kdatabase.net/k810274/ 1981-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k810274-clinix-r-tomographic-device-fda-510k.jpg K810274 - CLINIX-R TOMOGRAPHIC DEVICE K810274 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Mar 1981. https://www.510kdatabase.net/k810306/ 1981-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k810306-rheumatoid-factor-reagent-test-kit-fda-510k.jpg K810306 - RHEUMATOID FACTOR REAGENT TEST KIT K810306 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Mar 1981. https://www.510kdatabase.net/k810326/ 1981-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k810326-porocoat-tm-townley-anatomic-knee-fda-510k.jpg K810326 - POROCOAT TM TOWNLEY ANATOMIC KNEE K810326 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Mar 1981. https://www.510kdatabase.net/k810357/ 1981-03-11 monthly 0.5 https://www.510kdatabase.net/og-image/k810357-stress-test-system-fda-510k.jpg K810357 - STRESS TEST SYSTEM K810357 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Mar 1981. https://www.510kdatabase.net/k810463/ 1981-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k810463-emit-st-serum-benzodiazepine-assay-fda-510k.jpg K810463 - EMIT-ST SERUM BENZODIAZEPINE ASSAY K810463 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Mar 1981. https://www.510kdatabase.net/k810464/ 1981-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k810464-emit-st-serum-calbrator-fda-510k.jpg K810464 - EMIT-ST SERUM CALBRATOR K810464 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Mar 1981. https://www.510kdatabase.net/k810465/ 1981-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k810465-emit-st-ethyl-alcohol-serum-controls-fda-510k.jpg K810465 - EMIT-ST ETHYL ALCOHOL SERUM CONTROLS K810465 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Mar 1981. https://www.510kdatabase.net/k810466/ 1981-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k810466-ethyl-alcohol-serum-calibrator-fda-510k.jpg K810466 - ETHYL ALCOHOL SERUM CALIBRATOR K810466 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Mar 1981. https://www.510kdatabase.net/k810467/ 1981-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k810467-emit-st-serum-ethyl-alcohol-assay-fda-510k.jpg K810467 - EMIT-ST SERUM ETHYL ALCOHOL ASSAY K810467 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Mar 1981. https://www.510kdatabase.net/k810468/ 1981-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k810468-emit-st-serum-controls-fda-510k.jpg K810468 - EMIT-ST SERUM CONTROLS K810468 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Mar 1981. https://www.510kdatabase.net/k810511/ 1981-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k810511-beckman-du-8-spectrophotometer-fda-510k.jpg K810511 - BECKMAN DU-8 SPECTROPHOTOMETER K810511 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Mar 1981. https://www.510kdatabase.net/k810258/ 1981-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k810258-proximal-fermoral-hip-replacement-fda-510k.jpg K810258 - PROXIMAL FERMORAL HIP REPLACEMENT K810258 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Mar 1981. https://www.510kdatabase.net/k810412/ 1981-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k810412-usci-cardiovascular-catheter-fda-510k.jpg K810412 - USCI CARDIOVASCULAR CATHETER K810412 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 1981. https://www.510kdatabase.net/k810096/ 1981-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k810096-porcelain-powder-for-clinical-use-fda-510k.jpg K810096 - PORCELAIN POWDER FOR CLINICAL USE K810096 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Mar 1981. https://www.510kdatabase.net/k810245/ 1981-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k810245-implantable-pacemaker-lead-adapter-fda-510k.jpg K810245 - IMPLANTABLE PACEMAKER LEAD ADAPTER K810245 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Mar 1981. https://www.510kdatabase.net/k810273/ 1981-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k810273-davol-electro-medical-systems-fda-510k.jpg K810273 - DAVOL ELECTRO MEDICAL SYSTEMS K810273 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 1981. https://www.510kdatabase.net/k810292/ 1981-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k810292-cam-wrap-fda-510k.jpg K810292 - CAM-WRAP K810292 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medline Industries, Inc.. Cleared Mar 1981. https://www.510kdatabase.net/k810391/ 1981-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k810391-vogler-hysterectomy-forceps-small-lg-fda-510k.jpg K810391 - VOGLER HYSTERECTOMY FORCEPS (SMALL & LG) K810391 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Edward Weck, Inc.. Cleared Mar 1981. https://www.510kdatabase.net/k810402/ 1981-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k810402-ace-cold-bandage-fda-510k.jpg K810402 - ACE COLD BANDAGE K810402 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1981. https://www.510kdatabase.net/k810439/ 1981-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k810439-body-strap-fda-510k.jpg K810439 - BODY STRAP K810439 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Mar 1981. https://www.510kdatabase.net/k810442/ 1981-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k810442-hand-splints-and-components-fda-510k.jpg K810442 - HAND SPLINTS AND COMPONENTS K810442 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Mar 1981. https://www.510kdatabase.net/k810443/ 1981-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k810443-limb-orthosis-fda-510k.jpg K810443 - LIMB ORTHOSIS K810443 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Mar 1981. https://www.510kdatabase.net/k810444/ 1981-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k810444-non-measuring-exercisers-fda-510k.jpg K810444 - NON-MEASURING EXERCISERS K810444 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Mar 1981. https://www.510kdatabase.net/k810445/ 1981-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k810445-mechanical-table-fda-510k.jpg K810445 - MECHANICAL TABLE K810445 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Mar 1981. https://www.510kdatabase.net/k810446/ 1981-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k810446-vibrator-fda-510k.jpg K810446 - VIBRATOR K810446 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Mar 1981. https://www.510kdatabase.net/k810447/ 1981-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k810447-magic-cushion-massager-fda-510k.jpg K810447 - MAGIC CUSHION MASSAGER K810447 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Mar 1981. https://www.510kdatabase.net/k810448/ 1981-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k810448-wheelchair-accessories-fda-510k.jpg K810448 - WHEELCHAIR ACCESSORIES K810448 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Mar 1981. https://www.510kdatabase.net/k810449/ 1981-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k810449-transfer-aids-fda-510k.jpg K810449 - TRANSFER AIDS K810449 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Mar 1981. https://www.510kdatabase.net/k810450/ 1981-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k810450-truncal-orthosis-fda-510k.jpg K810450 - TRUNCAL ORTHOSIS K810450 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Mar 1981. https://www.510kdatabase.net/k810451/ 1981-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k810451-reuseable-hot-cold-packs-fda-510k.jpg K810451 - REUSEABLE HOT & COLD PACKS K810451 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Mar 1981. https://www.510kdatabase.net/k810452/ 1981-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k810452-non-powered-communication-systems-fda-510k.jpg K810452 - NON-POWERED COMMUNICATION SYSTEMS K810452 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Mar 1981. https://www.510kdatabase.net/k810453/ 1981-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k810453-dressing-adaptors-fda-510k.jpg K810453 - DRESSING ADAPTORS K810453 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Mar 1981. https://www.510kdatabase.net/k810454/ 1981-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k810454-homemaking-utensils-fda-510k.jpg K810454 - HOMEMAKING UTENSILS K810454 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Mar 1981. https://www.510kdatabase.net/k810455/ 1981-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k810455-eating-utensils-fda-510k.jpg K810455 - EATING UTENSILS K810455 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Mar 1981. https://www.510kdatabase.net/k810456/ 1981-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k810456-hygiene-adaptors-fda-510k.jpg K810456 - HYGIENE ADAPTORS K810456 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Mar 1981. https://www.510kdatabase.net/k810457/ 1981-03-04 monthly 0.5 https://www.510kdatabase.net/og-image/k810457-grooming-adaptors-fda-510k.jpg K810457 - GROOMING ADAPTORS K810457 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Mar 1981. https://www.510kdatabase.net/k803049/ 1981-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k803049-digital-radiography-chest-device-fda-510k.jpg K803049 - DIGITAL RADIOGRAPHY CHEST DEVICE K803049 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Mar 1981. https://www.510kdatabase.net/k810156/ 1981-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k810156-argyle-salem-sump-tube-fda-510k.jpg K810156 - ARGYLE SALEM SUMP TUBE K810156 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Sherwood Medical Co.. Cleared Mar 1981. https://www.510kdatabase.net/k803282/ 1981-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k803282-guardian-monitor-cardiovascular-fda-510k.jpg K803282 - GUARDIAN MONITOR (CARDIOVASCULAR) K803282 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Feb 1981. https://www.510kdatabase.net/k810441/ 1981-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k810441-universal-gonimeter-fda-510k.jpg K810441 - UNIVERSAL GONIMETER K810441 is a FDA 510(k) cleared neurology medical device. Manufacturer: Fred Sammons, Inc.. Cleared Feb 1981. https://www.510kdatabase.net/k810381/ 1981-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k810381-htsh-riabead-diagnostic-kit-fda-510k.jpg K810381 - HTSH RIABEAD DIAGNOSTIC KIT K810381 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Feb 1981. https://www.510kdatabase.net/k810046/ 1981-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k810046-cordia-a-fda-510k.jpg K810046 - CORDIA A K810046 is a FDA 510(k) cleared immunology medical device. Manufacturer: Cordis Corp.. Cleared Feb 1981. https://www.510kdatabase.net/k810183/ 1981-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k810183-pro-top-angio-shift-table-top-extension-fda-510k.jpg K810183 - PRO-TOP-ANGIO SHIFT TABLE TOP EXTENSION K810183 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Feb 1981. https://www.510kdatabase.net/k810194/ 1981-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k810194-wall-cassette-holder-trac44-fda-510k.jpg K810194 - WALL CASSETTE HOLDER - TRAC44 K810194 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Feb 1981. https://www.510kdatabase.net/k810302/ 1981-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k810302-quantimune-hlh-ria-human-lutenizing-horm-fda-510k.jpg K810302 - QUANTIMUNE HLH RIA HUMAN LUTENIZING HORM K810302 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Feb 1981. https://www.510kdatabase.net/k810345/ 1981-02-25 monthly 0.5 https://www.510kdatabase.net/og-image/k810345-liquid-scintillation-spectrophotometer-fda-510k.jpg K810345 - LIQUID SCINTILLATION SPECTROPHOTOMETER K810345 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Feb 1981. https://www.510kdatabase.net/k802348/ 1981-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k802348-triaxial-fda-510k.jpg K802348 - TRIAXIAL K802348 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Feb 1981. https://www.510kdatabase.net/k802920/ 1981-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k802920-inspiron-pulmonary-function-analyzer-fda-510k.jpg K802920 - INSPIRON PULMONARY FUNCTION ANALYZER K802920 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Feb 1981. https://www.510kdatabase.net/k803313/ 1981-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k803313-pacing-system-analyzer-fda-510k.jpg K803313 - PACING SYSTEM ANALYZER K803313 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Feb 1981. https://www.510kdatabase.net/k810355/ 1981-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k810355-alt-uv-test-fda-510k.jpg K810355 - ALT (UV) TEST K810355 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Feb 1981. https://www.510kdatabase.net/k810356/ 1981-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k810356-bicarbonate-test-fda-510k.jpg K810356 - BICARBONATE TEST K810356 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Feb 1981. https://www.510kdatabase.net/k810390/ 1981-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k810390-ast-uv-test-fda-510k.jpg K810390 - AST (UV) TEST K810390 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Feb 1981. https://www.510kdatabase.net/k802894/ 1981-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k802894-cordis-dow-c-dak-18mrc-artific-kidney-fda-510k.jpg K802894 - CORDIS DOW C-DAK 1.8MRC ARTIFIC-KIDNEY K802894 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Feb 1981. https://www.510kdatabase.net/k803167/ 1981-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k803167-brigham-total-ankle-prosthesis-fda-510k.jpg K803167 - BRIGHAM TOTAL ANKLE PROSTHESIS K803167 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Feb 1981. https://www.510kdatabase.net/k810118/ 1981-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k810118-ls1000-electronic-focus-fda-510k.jpg K810118 - LS1000 ELECTRONIC FOCUS K810118 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Feb 1981. https://www.510kdatabase.net/k810308/ 1981-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k810308-arterial-microcollection-set-fda-510k.jpg K810308 - ARTERIAL MICROCOLLECTION SET K810308 is a FDA 510(k) cleared hematology medical device. Manufacturer: American Dade. Cleared Feb 1981. https://www.510kdatabase.net/k810314/ 1981-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k810314-william-harvey-flowmeter-system-fda-510k.jpg K810314 - WILLIAM HARVEY FLOWMETER SYSTEM K810314 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Feb 1981. https://www.510kdatabase.net/k810319/ 1981-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k810319-cordis-stimucord-external-neutral-stim-fda-510k.jpg K810319 - CORDIS STIMUCORD EXTERNAL NEUTRAL STIM K810319 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cordis Corp.. Cleared Feb 1981. https://www.510kdatabase.net/k802840/ 1981-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k802840-alpha-antiplasm-assay-fda-510k.jpg K802840 - ALPHA-ANTIPLASM ASSAY K802840 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Feb 1981. https://www.510kdatabase.net/k803110/ 1981-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k803110-proteolytic-enzyme-control-fda-510k.jpg K803110 - PROTEOLYTIC ENZYME CONTROL K803110 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Feb 1981. https://www.510kdatabase.net/k810137/ 1981-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k810137-sof-band-high-stretch-bandages-fda-510k.jpg K810137 - SOF-BAND HIGH STRETCH BANDAGES K810137 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Feb 1981. https://www.510kdatabase.net/k802893/ 1981-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k802893-cordis-dow-c-dak-13mrc-artif-kidney-fda-510k.jpg K802893 - CORDIS DOW C-DAK 1.3MRC ARTIF. KIDNEY K802893 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Feb 1981. https://www.510kdatabase.net/k810158/ 1981-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k810158-davol-silicone-sheath-sump-drain-fda-510k.jpg K810158 - DAVOL SILICONE SHEATH SUMP DRAIN K810158 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Feb 1981. https://www.510kdatabase.net/k810384/ 1981-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k810384-intermedics-cyberlith-i-unipolar-cardiac-fda-510k.jpg K810384 - INTERMEDICS CYBERLITH I UNIPOLAR CARDIAC K810384 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Feb 1981. https://www.510kdatabase.net/k801584/ 1981-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k801584-multi-programmable-pacemaker-progrmr-fda-510k.jpg K801584 - MULTI-PROGRAMMABLE PACEMAKER & PROGRMR. K801584 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Feb 1981. https://www.510kdatabase.net/k802357/ 1981-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k802357-telemetry-pacemaker-monitor-fda-510k.jpg K802357 - TELEMETRY PACEMAKER MONITOR K802357 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Feb 1981. https://www.510kdatabase.net/k803304/ 1981-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k803304-acridine-orange-stain-fda-510k.jpg K803304 - ACRIDINE ORANGE STAIN K803304 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Feb 1981. https://www.510kdatabase.net/k810040/ 1981-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k810040-acridine-orange-stain-fda-510k.jpg K810040 - ACRIDINE ORANGE STAIN K810040 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Feb 1981. https://www.510kdatabase.net/k803126/ 1981-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k803126-exeter-total-hip-system-fda-510k.jpg K803126 - EXETER TOTAL HIP SYSTEM K803126 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Feb 1981. https://www.510kdatabase.net/k803127/ 1981-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k803127-howmedica-knee-brush-fda-510k.jpg K803127 - HOWMEDICA KNEE BRUSH K803127 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Feb 1981. https://www.510kdatabase.net/k810224/ 1981-02-10 monthly 0.5 https://www.510kdatabase.net/og-image/k810224-armstrong-spinal-appliance-fda-510k.jpg K810224 - ARMSTRONG SPINAL APPLIANCE K810224 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Feb 1981. https://www.510kdatabase.net/k802295/ 1981-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k802295-poly-flex-implantable-pacing-lead-fda-510k.jpg K802295 - POLY FLEX IMPLANTABLE PACING LEAD K802295 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Feb 1981. https://www.510kdatabase.net/k803196/ 1981-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k803196-flexible-pin-s-shaped-intramed-system-fda-510k.jpg K803196 - FLEXIBLE PIN S SHAPED INTRAMED. SYSTEM K803196 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Feb 1981. https://www.510kdatabase.net/k810216/ 1981-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k810216-argyle-rob-nels-fda-510k.jpg K810216 - ARGYLE ROB-NELS K810216 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Sherwood Medical Co.. Cleared Feb 1981. https://www.510kdatabase.net/k810229/ 1981-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k810229-sceptor-system-automated-model-216-fda-510k.jpg K810229 - SCEPTOR SYSTEM AUTOMATED MODEL 216 K810229 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Feb 1981. https://www.510kdatabase.net/k810023/ 1981-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k810023-hydrophilic-coated-catheter-fda-510k.jpg K810023 - HYDROPHILIC COATED CATHETER K810023 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Feb 1981. https://www.510kdatabase.net/k810005/ 1981-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k810005-safeed-extension-tubes-fda-510k.jpg K810005 - SAFEED EXTENSION TUBES K810005 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Terumo Medical Corp.. Cleared Feb 1981. https://www.510kdatabase.net/k810041/ 1981-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k810041-cordis-temporaty-curved-atrial-lead-fda-510k.jpg K810041 - CORDIS TEMPORATY CURVED ATRIAL LEAD K810041 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Feb 1981. https://www.510kdatabase.net/k810202/ 1981-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k810202-cordis-multifilar-pervenous-ventric-ld-fda-510k.jpg K810202 - CORDIS MULTIFILAR PERVENOUS VENTRIC. LD K810202 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Feb 1981. https://www.510kdatabase.net/k802199/ 1981-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k802199-stat-crit-hematocrit-measuring-instru-fda-510k.jpg K802199 - STAT-CRIT HEMATOCRIT MEASURING INSTRU K802199 is a FDA 510(k) cleared hematology medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Feb 1981. https://www.510kdatabase.net/k803037/ 1981-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k803037-william-harvey-vented-mediastinal-drain-fda-510k.jpg K803037 - WILLIAM HARVEY VENTED MEDIASTINAL DRAIN K803037 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Feb 1981. https://www.510kdatabase.net/k803235/ 1981-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k803235-geo-tibial-retainer-rotational-fda-510k.jpg K803235 - GEO-TIBIAL RETAINER ROTATIONAL K803235 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Feb 1981. https://www.510kdatabase.net/k810120/ 1981-02-04 monthly 0.5 https://www.510kdatabase.net/og-image/k810120-reinforced-hip-cup-fda-510k.jpg K810120 - REINFORCED HIP CUP K810120 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Feb 1981. https://www.510kdatabase.net/k803000/ 1981-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k803000-ionescu-shiley-aortic-graft-valve-fda-510k.jpg K803000 - IONESCU-SHILEY AORTIC GRAFT VALVE K803000 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Feb 1981. https://www.510kdatabase.net/k810093/ 1981-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k810093-emit-st-phencyclidine-assay-fda-510k.jpg K810093 - EMIT-ST PHENCYCLIDINE ASSAY K810093 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Feb 1981. https://www.510kdatabase.net/k810106/ 1981-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k810106-shiley-single-cannula-tracheostomy-tube-fda-510k.jpg K810106 - SHILEY SINGLE CANNULA TRACHEOSTOMY TUBE K810106 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shiley, Inc.. Cleared Feb 1981. https://www.510kdatabase.net/k803300/ 1981-01-29 monthly 0.5 https://www.510kdatabase.net/og-image/k803300-inpersol-capd-bag-port-clamp-fda-510k.jpg K803300 - INPERSOL CAPD BAG PORT CLAMP K803300 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Abbott Laboratories. Cleared Jan 1981. https://www.510kdatabase.net/k803181/ 1981-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k803181-scanner-computerized-tomographic-fda-510k.jpg K803181 - SCANNER, COMPUTERIZED TOMOGRAPHIC K803181 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jan 1981. https://www.510kdatabase.net/k803236/ 1981-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k803236-cybrex-valproic-acid-fda-510k.jpg K803236 - CYBREX VALPROIC ACID K803236 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Jan 1981. https://www.510kdatabase.net/k803241/ 1981-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k803241-histological-embedding-media-fda-510k.jpg K803241 - HISTOLOGICAL EMBEDDING MEDIA K803241 is a FDA 510(k) cleared pathology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Jan 1981. https://www.510kdatabase.net/k810042/ 1981-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k810042-bactec-bacterial-detection-system-5-fda-510k.jpg K810042 - BACTEC BACTERIAL DETECTION SYSTEM: #5 K810042 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jan 1981. https://www.510kdatabase.net/k810053/ 1981-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k810053-johnson-johnson-adhesive-film-dressing-fda-510k.jpg K810053 - JOHNSON & JOHNSON ADHESIVE FILM DRESSING K810053 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jan 1981. https://www.510kdatabase.net/k803248/ 1981-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k803248-ames-sera-pak-hemoglobin-reagent-fda-510k.jpg K803248 - AMES SERA-PAK HEMOGLOBIN REAGENT K803248 is a FDA 510(k) cleared hematology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Jan 1981. https://www.510kdatabase.net/k810062/ 1981-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k810062-bi-centric-bi-polar-endoprosthesis-fda-510k.jpg K810062 - BI-CENTRIC BI-POLAR ENDOPROSTHESIS K810062 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jan 1981. https://www.510kdatabase.net/k803191/ 1981-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k803191-prosthesis-hip-femoral-component-metal-fda-510k.jpg K803191 - PROSTHESIS, HIP FEMORAL COMPONENT METAL K803191 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Jan 1981. https://www.510kdatabase.net/k803192/ 1981-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k803192-hcl-acetabular-components-fda-510k.jpg K803192 - HCL ACETABULAR COMPONENTS K803192 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Jan 1981. https://www.510kdatabase.net/k810061/ 1981-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k810061-curved-sherman-bone-plate-fda-510k.jpg K810061 - CURVED SHERMAN BONE PLATE K810061 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jan 1981. https://www.510kdatabase.net/k802717/ 1981-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k802717-hp-model-4710a-ecg-transmitter-fda-510k.jpg K802717 - HP MODEL 4710A ECG TRANSMITTER K802717 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Jan 1981. https://www.510kdatabase.net/k803120/ 1981-01-22 monthly 0.5 https://www.510kdatabase.net/og-image/k803120-tilting-imaging-table-846t-fda-510k.jpg K803120 - TILTING IMAGING TABLE #846T K803120 is a FDA 510(k) cleared radiology medical device. Manufacturer: Quinton, Inc.. Cleared Jan 1981. https://www.510kdatabase.net/k803219/ 1981-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k803219-adc-500-automated-differ-cell-cntr-sy-fda-510k.jpg K803219 - ADC-500 AUTOMATED DIFFER. CELL CNTR. SY. K803219 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Jan 1981. https://www.510kdatabase.net/k810003/ 1981-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k810003-no-boil-folic-acid-kit-fda-510k.jpg K810003 - 'NO-BOIL' FOLIC ACID KIT K810003 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jan 1981. https://www.510kdatabase.net/k803231/ 1981-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k803231-thb-6000-hardshell-bubble-oxygenator-fda-510k.jpg K803231 - THB 6000 HARDSHELL BUBBLE OXYGENATOR K803231 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Jan 1981. https://www.510kdatabase.net/k803267/ 1981-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k803267-automated-immuochemistry-system-fda-510k.jpg K803267 - AUTOMATED IMMUOCHEMISTRY SYSTEM K803267 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jan 1981. https://www.510kdatabase.net/k803281/ 1981-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k803281-automated-electrophoresis-system-fda-510k.jpg K803281 - AUTOMATED ELECTROPHORESIS SYSTEM K803281 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Jan 1981. https://www.510kdatabase.net/k803305/ 1981-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k803305-dupont-aca-creatine-kinase-verifiers-fda-510k.jpg K803305 - DUPONT 'ACA' CREATINE KINASE VERIFIERS K803305 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Jan 1981. https://www.510kdatabase.net/k810001/ 1981-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k810001-no-boil-dualcount-kit-fda-510k.jpg K810001 - 'NO-BOIL' DUALCOUNT KIT K810001 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jan 1981. https://www.510kdatabase.net/k810002/ 1981-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k810002-no-boil-vitamin-b12-kit-fda-510k.jpg K810002 - 'NO-BOIL' VITAMIN B12 KIT K810002 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jan 1981. https://www.510kdatabase.net/k802801/ 1981-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k802801-ge-rtplan-magnetic-tape-drive-option-fda-510k.jpg K802801 - GE RT/PLAN MAGNETIC TAPE DRIVE OPTION K802801 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jan 1981. https://www.510kdatabase.net/k803125/ 1981-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k803125-bone-dri-surgical-sponge-fda-510k.jpg K803125 - BONE-DRI SURGICAL SPONGE K803125 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Howmedica Corp.. Cleared Jan 1981. https://www.510kdatabase.net/k803258/ 1981-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k803258-cordis-hakim-ascites-valve-system-fda-510k.jpg K803258 - CORDIS HAKIM ASCITES VALVE SYSTEM K803258 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Jan 1981. https://www.510kdatabase.net/k803261/ 1981-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k803261-t3-riabead-diagnostic-kit-fda-510k.jpg K803261 - T3 RIABEAD DIAGNOSTIC KIT K803261 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jan 1981. https://www.510kdatabase.net/k803269/ 1981-01-15 monthly 0.5 https://www.510kdatabase.net/og-image/k803269-capsule-dental-amalgam-fda-510k.jpg K803269 - CAPSULE DENTAL AMALGAM K803269 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jan 1981. https://www.510kdatabase.net/k802975/ 1981-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k802975-anteriorposterior-composite-restorative-fda-510k.jpg K802975 - ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE K802975 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jan 1981. https://www.510kdatabase.net/k803310/ 1981-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k803310-ceramco-porcelain-fda-510k.jpg K803310 - CERAMCO PORCELAIN K803310 is a FDA 510(k) cleared dental medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jan 1981. https://www.510kdatabase.net/k801601/ 1981-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k801601-datascopeavco-connector-fda-510k.jpg K801601 - DATASCOPE/AVCO CONNECTOR K801601 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Jan 1981. https://www.510kdatabase.net/k802167/ 1981-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k802167-percor-datascope-intra-aortic-balloon-fda-510k.jpg K802167 - PERCOR DATASCOPE INTRA-AORTIC BALLOON K802167 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Jan 1981. https://www.510kdatabase.net/k803123/ 1981-01-13 monthly 0.5 https://www.510kdatabase.net/og-image/k803123-crt-display-1310b-fda-510k.jpg K803123 - CRT DISPLAY #1310B K803123 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Jan 1981. https://www.510kdatabase.net/k802826/ 1981-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k802826-paragon-electro-creatine-kinase-test-ki-fda-510k.jpg K802826 - PARAGON ELECTRO. CREATINE KINASE TEST KI K802826 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jan 1981. https://www.510kdatabase.net/k802953/ 1981-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k802953-digital-fluorographic-x-ray-system-fda-510k.jpg K802953 - DIGITAL FLUOROGRAPHIC X-RAY SYSTEM K802953 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jan 1981. https://www.510kdatabase.net/k802996/ 1981-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k802996-vector-100-x-ray-generator-fda-510k.jpg K802996 - VECTOR-100 X-RAY GENERATOR K802996 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Jan 1981. https://www.510kdatabase.net/k803108/ 1981-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k803108-helena-hba2-quik-column-method-fda-510k.jpg K803108 - HELENA HBA2 QUIK COLUMN METHOD K803108 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Jan 1981. https://www.510kdatabase.net/k803166/ 1981-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k803166-double-ball-joint-fda-510k.jpg K803166 - DOUBLE BALL JOINT K803166 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jan 1981. https://www.510kdatabase.net/k803187/ 1981-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k803187-argyle-universal-poole-suction-tube-fda-510k.jpg K803187 - ARGYLE UNIVERSAL POOLE SUCTION TUBE K803187 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Jan 1981. https://www.510kdatabase.net/k803237/ 1981-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k803237-ames-sera-pak-albumin-reagent-kit-fda-510k.jpg K803237 - AMES SERA-PAK ALBUMIN REAGENT KIT K803237 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Jan 1981. https://www.510kdatabase.net/k803254/ 1981-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k803254-liquid-stat-reagent-for-assay-of-choles-fda-510k.jpg K803254 - LIQUID-STAT REAGENT FOR ASSAY OF CHOLES. K803254 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jan 1981. https://www.510kdatabase.net/k802522/ 1981-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k802522-delta-lite-casting-tape-splints-fda-510k.jpg K802522 - DELTA-LITE CASTING TAPE & SPLINTS K802522 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jan 1981. https://www.510kdatabase.net/k802757/ 1981-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k802757-buffered-charcoal-yeast-extract-agar-fda-510k.jpg K802757 - BUFFERED CHARCOAL YEAST EXTRACT AGAR K802757 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Jan 1981. https://www.510kdatabase.net/k802921/ 1981-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k802921-iclh-tibial-plateau-fda-510k.jpg K802921 - ICLH TIBIAL PLATEAU K802921 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jan 1981. https://www.510kdatabase.net/k803093/ 1981-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k803093-slit-catheter-system-fda-510k.jpg K803093 - SLIT CATHETER SYSTEM K803093 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jan 1981. https://www.510kdatabase.net/k803212/ 1981-01-08 monthly 0.5 https://www.510kdatabase.net/og-image/k803212-bauer-black-arm-sling-wdetach-pouch-fda-510k.jpg K803212 - BAUER & BLACK ARM SLING W/DETACH. POUCH K803212 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jan 1981. https://www.510kdatabase.net/k801338/ 1981-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k801338-cyberlith-programmer-fda-510k.jpg K801338 - CYBERLITH PROGRAMMER K801338 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Jan 1981. https://www.510kdatabase.net/k802613/ 1981-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k802613-c-pak-model-12-artificial-kidney-fda-510k.jpg K802613 - C-PAK MODEL 12 ARTIFICIAL KIDNEY K802613 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Jan 1981. https://www.510kdatabase.net/k802695/ 1981-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k802695-datason-rtl-ii-fda-510k.jpg K802695 - DATASON RTL II K802695 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jan 1981. https://www.510kdatabase.net/k802708/ 1981-01-07 monthly 0.5 https://www.510kdatabase.net/og-image/k802708-system-echo-pulsed-ultrasonic-diag-fda-510k.jpg K802708 - SYSTEM, ECHO, PULSED ULTRASONIC DIAG. K802708 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jan 1981. https://www.510kdatabase.net/k810029/ 1981-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k810029-regulator-venoset-w022-micron-ivex-fda-510k.jpg K810029 - REGULATOR VENOSET W/0.22 MICRON IVEX K810029 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Jan 1981. https://www.510kdatabase.net/k803185/ 1981-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k803185-non-conductive-anesthesia-face-mask-fda-510k.jpg K803185 - NON-CONDUCTIVE ANESTHESIA FACE MASK K803185 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jan 1981. https://www.510kdatabase.net/k803043/ 1981-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k803043-riaphase-125i-prost-acid-phosph-kit-fda-510k.jpg K803043 - RIAPHASE (125I) PROST. ACID PHOSPH. KIT K803043 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jan 1981. https://www.510kdatabase.net/k803044/ 1981-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k803044-immu-trace-t3-uptake-t3u-reagents-fda-510k.jpg K803044 - IMMU-TRACE T3 UPTAKE (T3U) REAGENTS K803044 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Jan 1981. https://www.510kdatabase.net/k803046/ 1981-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k803046-immu-trace-t4-ria-procedure-fda-510k.jpg K803046 - IMMU-TRACE T4 RIA PROCEDURE K803046 is a FDA 510(k) cleared chemistry medical device. Manufacturer: American Dade. Cleared Jan 1981. https://www.510kdatabase.net/k803087/ 1981-01-02 monthly 0.5 https://www.510kdatabase.net/og-image/k803087-lancer-creatinine-microsample-stat-ana-fda-510k.jpg K803087 - LANCER CREATININE MICROSAMPLE STAT ANA K803087 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sherwood Medical Co.. Cleared Jan 1981. https://www.510kdatabase.net/k801970/ 1980-12-31 monthly 0.5 https://www.510kdatabase.net/og-image/k801970-ucla-shoulder-fda-510k.jpg K801970 - UCLA SHOULDER K801970 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Dec 1980. https://www.510kdatabase.net/k802758/ 1980-12-31 monthly 0.5 https://www.510kdatabase.net/og-image/k802758-selective-charcoal-yeast-extract-agar-fda-510k.jpg K802758 - SELECTIVE CHARCOAL YEAST EXTRACT AGAR K802758 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Dec 1980. https://www.510kdatabase.net/k803064/ 1980-12-31 monthly 0.5 https://www.510kdatabase.net/og-image/k803064-zimmer-electrical-muscle-stimulator-fda-510k.jpg K803064 - ZIMMER ELECTRICAL MUSCLE STIMULATOR K803064 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Zimmer, Inc.. Cleared Dec 1980. https://www.510kdatabase.net/k803165/ 1980-12-31 monthly 0.5 https://www.510kdatabase.net/og-image/k803165-acetabular-cement-compressor-fda-510k.jpg K803165 - ACETABULAR CEMENT COMPRESSOR K803165 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Dec 1980. https://www.510kdatabase.net/k802967/ 1980-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k802967-dispersalloy-dispersed-phase-alloy-self--fda-510k.jpg K802967 - DISPERSALLOY-DISPERSED PHASE ALLOY SELF- K802967 is a FDA 510(k) cleared dental medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Dec 1980. https://www.510kdatabase.net/k803015/ 1980-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k803015-hemespec-ii-fda-510k.jpg K803015 - HEMESPEC II K803015 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Dec 1980. https://www.510kdatabase.net/k803016/ 1980-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k803016-helena-hemespec-ii-total-hemoglobin-met-fda-510k.jpg K803016 - HELENA HEMESPEC II TOTAL HEMOGLOBIN MET. K803016 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Dec 1980. https://www.510kdatabase.net/k803038/ 1980-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k803038-proximateii-disposable-skin-stapler-fda-510k.jpg K803038 - PROXIMATE*II DISPOSABLE SKIN STAPLER K803038 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Dec 1980. https://www.510kdatabase.net/k802912/ 1980-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k802912-helena-at-iii-quiplate-procedure-fda-510k.jpg K802912 - HELENA AT-III QUIPLATE PROCEDURE K802912 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Dec 1980. https://www.510kdatabase.net/k802944/ 1980-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k802944-quantimune-e3-ria-fda-510k.jpg K802944 - QUANTIMUNE E3 RIA K802944 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bio-Rad. Cleared Dec 1980. https://www.510kdatabase.net/k803019/ 1980-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k803019-seralyzer-ldh-reagent-strips-calibr-fda-510k.jpg K803019 - SERALYZER LDH REAGENT STRIPS, CALIBR K803019 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Dec 1980. https://www.510kdatabase.net/k803022/ 1980-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k803022-cdc-anaerobe-bld-agar-wkanamycin-etc-fda-510k.jpg K803022 - CDC ANAEROBE BLD AGAR W/KANAMYCIN ETC. K803022 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Dec 1980. https://www.510kdatabase.net/k803023/ 1980-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k803023-enriched-thioglycollate-medium-fda-510k.jpg K803023 - ENRICHED THIOGLYCOLLATE MEDIUM K803023 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Dec 1980. https://www.510kdatabase.net/k803024/ 1980-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k803024-cdc-anaerobe-laked-bl-agar-wparamomy-fda-510k.jpg K803024 - CDC ANAEROBE LAKED BL AGAR W/PARAMOMY. K803024 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Dec 1980. https://www.510kdatabase.net/k803025/ 1980-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k803025-cdc-anaerobe-blood-agar-fda-510k.jpg K803025 - CDC ANAEROBE BLOOD AGAR K803025 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Dec 1980. https://www.510kdatabase.net/k803026/ 1980-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k803026-peptone-yeast-extract-glucose-broth-fda-510k.jpg K803026 - PEPTONE YEAST EXTRACT GLUCOSE BROTH K803026 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Dec 1980. https://www.510kdatabase.net/k803027/ 1980-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k803027-cdc-anaerobe-bl-agar-wphenylethyl-etc-fda-510k.jpg K803027 - CDC ANAEROBE BL AGAR W/PHENYLETHYL ETC. K803027 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Dec 1980. https://www.510kdatabase.net/k803045/ 1980-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k803045-immu-trace-digoxin-125i-radioimmun-fda-510k.jpg K803045 - IMMU-TRACE DIGOXIN (125I) RADIOIMMUN. K803045 is a FDA 510(k) cleared toxicology medical device. Manufacturer: American Dade. Cleared Dec 1980. https://www.510kdatabase.net/k803054/ 1980-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k803054-saf-fixative-fda-510k.jpg K803054 - SAF FIXATIVE K803054 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Dec 1980. https://www.510kdatabase.net/k803075/ 1980-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k803075-digoxin-riabead-diagnostic-kit-fda-510k.jpg K803075 - DIGOXIN RIABEAD DIAGNOSTIC KIT K803075 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Dec 1980. https://www.510kdatabase.net/k803082/ 1980-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k803082-adhesive-peristomal-covering-wwo-conn-fda-510k.jpg K803082 - ADHESIVE PERISTOMAL COVERING W/WO CONN. K803082 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Dec 1980. https://www.510kdatabase.net/k803107/ 1980-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k803107-ames-tda-amikacin-control-serum-fda-510k.jpg K803107 - AMES TDA AMIKACIN CONTROL SERUM K803107 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Dec 1980. https://www.510kdatabase.net/k802879/ 1980-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k802879-buckberg-shiley-blood-cardioplegic-spl-fda-510k.jpg K802879 - BUCKBERG-SHILEY BLOOD CARDIOPLEGIC SPL. K802879 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Dec 1980. https://www.510kdatabase.net/k802881/ 1980-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k802881-absele-absorbable-bone-sealant-fda-510k.jpg K802881 - ABSELE* ABSORBABLE BONE SEALANT K802881 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Ethicon, Inc.. Cleared Dec 1980. https://www.510kdatabase.net/k802891/ 1980-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k802891-argyle-double-seal-chest-drainage-unit-fda-510k.jpg K802891 - ARGYLE DOUBLE SEAL CHEST DRAINAGE UNIT K802891 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sherwood Medical Co.. Cleared Dec 1980. https://www.510kdatabase.net/k802902/ 1980-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k802902-cybrex-carbamazepine-fda-510k.jpg K802902 - CYBREX CARBAMAZEPINE K802902 is a FDA 510(k) cleared immunology medical device. Manufacturer: Abbott Laboratories. Cleared Dec 1980. https://www.510kdatabase.net/k802923/ 1980-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k802923-beckman-astra-systems-calcium-chemistry-fda-510k.jpg K802923 - BECKMAN ASTRA SYSTEMS CALCIUM CHEMISTRY K802923 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Dec 1980. https://www.510kdatabase.net/k801748/ 1980-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k801748-3m-i-125-seeds-in-absorbable-carrier-fda-510k.jpg K801748 - 3M I-125 SEEDS IN ABSORBABLE CARRIER K801748 is a FDA 510(k) cleared radiology medical device. Manufacturer: 3M Company. Cleared Dec 1980. https://www.510kdatabase.net/k802339/ 1980-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k802339-eia-rubella-g-fda-510k.jpg K802339 - EIA RUBELLA-G K802339 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Dec 1980. https://www.510kdatabase.net/k802578/ 1980-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k802578-pace-4-automatic-ria-gamma-couter-fda-510k.jpg K802578 - PACE-4-AUTOMATIC RIA GAMMA-COUTER K802578 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Dec 1980. https://www.510kdatabase.net/k802688/ 1980-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k802688-rheumatoid-factor-test-systems-fda-510k.jpg K802688 - RHEUMATOID FACTOR TEST SYSTEMS K802688 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Dec 1980. https://www.510kdatabase.net/k802853/ 1980-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k802853-cleanser-root-canal-fda-510k.jpg K802853 - CLEANSER, ROOT CANAL K802853 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Dec 1980. https://www.510kdatabase.net/k802106/ 1980-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k802106-lewis-trapezo-metacarpal-prosthesis-fda-510k.jpg K802106 - LEWIS TRAPEZO METACARPAL PROSTHESIS K802106 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Dec 1980. https://www.510kdatabase.net/k802901/ 1980-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k802901-travenol-infusion-pump-2m8016-fda-510k.jpg K802901 - TRAVENOL INFUSION PUMP-2M8016 K802901 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Dec 1980. https://www.510kdatabase.net/k802922/ 1980-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k802922-porous-coated-anatomical-total-knee-fda-510k.jpg K802922 - POROUS COATED ANATOMICAL-TOTAL KNEE K802922 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Dec 1980. https://www.510kdatabase.net/k801879/ 1980-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k801879-puig-massana-shiley-annuloplasty-ring-fda-510k.jpg K801879 - PUIG MASSANA-SHILEY ANNULOPLASTY RING K801879 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Dec 1980. https://www.510kdatabase.net/k801954/ 1980-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k801954-hp-model-77020a-ultrasound-system-fda-510k.jpg K801954 - HP MODEL 77020A ULTRASOUND SYSTEM K801954 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Dec 1980. https://www.510kdatabase.net/k802462/ 1980-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k802462-synthes-spinal-implant-system-fda-510k.jpg K802462 - SYNTHES SPINAL IMPLANT SYSTEM K802462 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Dec 1980. https://www.510kdatabase.net/k802571/ 1980-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k802571-cye-biphasic-blood-culture-medium-fda-510k.jpg K802571 - CYE BIPHASIC BLOOD CULTURE MEDIUM K802571 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Dec 1980. https://www.510kdatabase.net/k802667/ 1980-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k802667-argyle-closed-urinary-drainage-set-fda-510k.jpg K802667 - ARGYLE CLOSED URINARY DRAINAGE SET K802667 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Sherwood Medical Co.. Cleared Dec 1980. https://www.510kdatabase.net/k802875/ 1980-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k802875-argyle-hematuria-balloon-catheter-fda-510k.jpg K802875 - ARGYLE HEMATURIA BALLOON CATHETER K802875 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Sherwood Medical Co.. Cleared Dec 1980. https://www.510kdatabase.net/k802887/ 1980-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k802887-model-eeg-4221-fda-510k.jpg K802887 - MODEL EEG 4221 K802887 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Dec 1980. https://www.510kdatabase.net/k802906/ 1980-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k802906-william-harvey-oxygenating-gas-filter-fda-510k.jpg K802906 - WILLIAM HARVEY OXYGENATING GAS FILTER K802906 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 1980. https://www.510kdatabase.net/k802628/ 1980-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k802628-paragon-electrophoresis-lactate-reagkit-fda-510k.jpg K802628 - PARAGON ELECTROPHORESIS LACTATE REAG.KIT K802628 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Dec 1980. https://www.510kdatabase.net/k802721/ 1980-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k802721-glycohemoglobin-in-whole-blood-fda-510k.jpg K802721 - GLYCOHEMOGLOBIN IN WHOLE BLOOD K802721 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Chemical Co.. Cleared Dec 1980. https://www.510kdatabase.net/k802742/ 1980-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k802742-sera-pak-total-protein-reagent-fda-510k.jpg K802742 - SERA-PAK TOTAL PROTEIN REAGENT K802742 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Dec 1980. https://www.510kdatabase.net/k802777/ 1980-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k802777-argyle-connect-tube-con-non-fda-510k.jpg K802777 - ARGYLE CONNECT TUBE-CON & NON K802777 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Dec 1980. https://www.510kdatabase.net/k802821/ 1980-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k802821-paragon-hemoglobin-electro-reag-kit-fda-510k.jpg K802821 - PARAGON HEMOGLOBIN ELECTRO. REAG. KIT K802821 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Dec 1980. https://www.510kdatabase.net/k802822/ 1980-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k802822-paragon-lipoprotein-electro-reag-kit-fda-510k.jpg K802822 - PARAGON LIPOPROTEIN ELECTRO. REAG. KIT K802822 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Dec 1980. https://www.510kdatabase.net/k802854/ 1980-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k802854-beckman-ics-drug-control-sera-fda-510k.jpg K802854 - BECKMAN ICS DRUG CONTROL SERA K802854 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Dec 1980. https://www.510kdatabase.net/k802872/ 1980-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k802872-aufranc-turner-ats-total-hip-system-fda-510k.jpg K802872 - AUFRANC-TURNER ATS TOTAL HIP SYSTEM K802872 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Dec 1980. https://www.510kdatabase.net/k802692/ 1980-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k802692-lancer-uric-acid-autostat-kit-fda-510k.jpg K802692 - LANCER URIC ACID AUTO/STAT KIT K802692 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sherwood Medical Co.. Cleared Dec 1980. https://www.510kdatabase.net/k802724/ 1980-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k802724-ames-sera-pak-uric-acid-reagent-kit-fda-510k.jpg K802724 - AMES SERA-PAK URIC ACID REAGENT KIT K802724 is a FDA 510(k) cleared hematology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Dec 1980. https://www.510kdatabase.net/k802743/ 1980-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k802743-ames-sera-pak-cholesterol-reagent-kit-fda-510k.jpg K802743 - AMES SERA-PAK CHOLESTEROL REAGENT KIT K802743 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Dec 1980. https://www.510kdatabase.net/k802810/ 1980-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k802810-hexokinase-glucose-fda-510k.jpg K802810 - HEXOKINASE, GLUCOSE K802810 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Dec 1980. https://www.510kdatabase.net/k802820/ 1980-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k802820-travenol-24-hr-infusor-elastomeric-pp-fda-510k.jpg K802820 - TRAVENOL 24 HR. INFUSOR (ELASTOMERIC PP) K802820 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Dec 1980. https://www.510kdatabase.net/k802548/ 1980-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k802548-generator-high-volt-x-ray-diag-mpx80-fda-510k.jpg K802548 - GENERATOR, HIGH VOLT, X-RAY, DIAG. MPX80 K802548 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Dec 1980. https://www.510kdatabase.net/k802549/ 1980-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k802549-generator-high-volt-x-ray-mpx-100-fda-510k.jpg K802549 - GENERATOR, HIGH VOLT, X-RAY, MPX 100 K802549 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Dec 1980. https://www.510kdatabase.net/k802550/ 1980-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k802550-generator-high-volt-x-ray-mpx-125-fda-510k.jpg K802550 - GENERATOR, HIGH VOLT, X-RAY, MPX 125 K802550 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Dec 1980. https://www.510kdatabase.net/k802551/ 1980-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k802551-generator-high-volt-x-ray-mpx100125-fda-510k.jpg K802551 - GENERATOR, HIGH VOLT, X-RAY, MPX100/125 K802551 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Dec 1980. https://www.510kdatabase.net/k801172/ 1980-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k801172-intermedics-lifeline-tle-endocardial-fda-510k.jpg K801172 - INTERMEDICS' LIFELINE TLE ENDOCARDIAL K801172 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Dec 1980. https://www.510kdatabase.net/k801284/ 1980-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k801284-low-profile-lead-connector-fda-510k.jpg K801284 - LOW PROFILE LEAD CONNECTOR MODIFICATION (4002) K801284 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Dec 1980. https://www.510kdatabase.net/k802054/ 1980-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k802054-travenol-ultrasonic-nebulizer-cups-fda-510k.jpg K802054 - TRAVENOL ULTRASONIC NEBULIZER CUPS K802054 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Dec 1980. https://www.510kdatabase.net/k802124/ 1980-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k802124-gristina-glenoid-prosthesis-fda-510k.jpg K802124 - GRISTINA GLENOID PROSTHESIS K802124 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Dec 1980. https://www.510kdatabase.net/k802309/ 1980-12-01 monthly 0.5 https://www.510kdatabase.net/og-image/k802309-ms-2-identification-system-fda-510k.jpg K802309 - MS-2 IDENTIFICATION SYSTEM K802309 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Dec 1980. https://www.510kdatabase.net/k802316/ 1980-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k802316-pds-thermal-dilution-cardiac-moduleout-fda-510k.jpg K802316 - PDS THERMAL DILUTION CARDIAC MODULE(OUT) K802316 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: General Electric Co.. Cleared Nov 1980. https://www.510kdatabase.net/k802475/ 1980-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k802475-a2-image-processing-system-fda-510k.jpg K802475 - A2 IMAGE PROCESSING SYSTEM K802475 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medtronic Vascular. Cleared Nov 1980. https://www.510kdatabase.net/k802686/ 1980-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k802686-hp-model-8880a-filter-fda-510k.jpg K802686 - HP MODEL 8880A FILTER K802686 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Nov 1980. https://www.510kdatabase.net/k802718/ 1980-11-26 monthly 0.5 https://www.510kdatabase.net/og-image/k802718-model-4700a-electrocardiograph-fda-510k.jpg K802718 - MODEL 4700A ELECTROCARDIOGRAPH K802718 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Nov 1980. https://www.510kdatabase.net/k802668/ 1980-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k802668-cybrex-tobramycin-fda-510k.jpg K802668 - CYBREX TOBRAMYCIN K802668 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1980. https://www.510kdatabase.net/k802811/ 1980-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k802811-monoject-root-canal-filling-mat-needle-fda-510k.jpg K802811 - MONOJECT ROOT CANAL FILLING MAT. NEEDLE K802811 is a FDA 510(k) cleared dental medical device. Manufacturer: Sherwood Medical Co.. Cleared Nov 1980. https://www.510kdatabase.net/k802221/ 1980-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k802221-chronocor-iv-model-250-fda-510k.jpg K802221 - CHRONOCOR IV MODEL 250 K802221 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Nov 1980. https://www.510kdatabase.net/k802460/ 1980-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k802460-helfet-elbow-prosthesis-fda-510k.jpg K802460 - HELFET ELBOW PROSTHESIS K802460 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Nov 1980. https://www.510kdatabase.net/k802722/ 1980-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k802722-external-fixation-system-fda-510k.jpg K802722 - EXTERNAL FIXATION SYSTEM K802722 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Nov 1980. https://www.510kdatabase.net/k802723/ 1980-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k802723-extended-balljoint-grip-fda-510k.jpg K802723 - EXTENDED BALLJOINT GRIP K802723 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Nov 1980. https://www.510kdatabase.net/k802776/ 1980-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k802776-hoffman-leg-lengthening-device-fda-510k.jpg K802776 - HOFFMAN LEG LENGTHENING DEVICE K802776 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Nov 1980. https://www.510kdatabase.net/k800870/ 1980-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k800870-medtronic-model-6958-fda-510k.jpg K800870 - MEDTRONIC MODEL 6958 K800870 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Nov 1980. https://www.510kdatabase.net/k801934/ 1980-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k801934-worrell-patella-femoral-shield-fda-510k.jpg K801934 - WORRELL PATELLA FEMORAL SHIELD K801934 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Nov 1980. https://www.510kdatabase.net/k801986/ 1980-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k801986-datason-db-system-fda-510k.jpg K801986 - DATASON DB SYSTEM K801986 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Nov 1980. https://www.510kdatabase.net/k802166/ 1980-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k802166-model-as-7b-autosyringe-infusion-pump-fda-510k.jpg K802166 - MODEL AS* 7B AUTOSYRINGE INFUSION PUMP K802166 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Nov 1980. https://www.510kdatabase.net/k802232/ 1980-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k802232-ab-trol-coagulation-control-fda-510k.jpg K802232 - AB-TROL COAGULATION CONTROL K802232 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Nov 1980. https://www.510kdatabase.net/k802557/ 1980-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k802557-emergency-department-laceration-kit--fda-510k.jpg K802557 - EMERGENCY DEPARTMENT LACERATION KIT- K802557 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Nov 1980. https://www.510kdatabase.net/k802562/ 1980-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k802562-prisma-seal-fda-510k.jpg K802562 - PRISMA SEAL K802562 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Nov 1980. https://www.510kdatabase.net/k802572/ 1980-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k802572-beckman-liquid-stat-ld-l-uv-enzyme-fda-510k.jpg K802572 - BECKMAN LIQUID-STAT LD-L-UV ENZYME K802572 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Nov 1980. https://www.510kdatabase.net/k802574/ 1980-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k802574-beckman-liquid-stat-liquidalkaline-pho-fda-510k.jpg K802574 - BECKMAN LIQUID STAT LIQUID/ALKALINE PHO K802574 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Nov 1980. https://www.510kdatabase.net/k802579/ 1980-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k802579-cybrex-tm-fpq-fluorescene-polarization-fda-510k.jpg K802579 - CYBREX TM FPQ FLUORESCENE POLARIZATION K802579 is a FDA 510(k) cleared pathology medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1980. https://www.510kdatabase.net/k802581/ 1980-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k802581-bekcman-astra-systems-amylase-chemistry-fda-510k.jpg K802581 - BEKCMAN ASTRA SYSTEMS AMYLASE CHEMISTRY K802581 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Nov 1980. https://www.510kdatabase.net/k802592/ 1980-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k802592-paragon-serum-protein-electrophoresis-fda-510k.jpg K802592 - PARAGON SERUM PROTEIN ELECTROPHORESIS K802592 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Nov 1980. https://www.510kdatabase.net/k802594/ 1980-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k802594-beckman-dp-5500-data-reduction-system-fda-510k.jpg K802594 - BECKMAN DP-5500 DATA REDUCTION SYSTEM K802594 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Nov 1980. https://www.510kdatabase.net/k802623/ 1980-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k802623-emit-stm-amphetamine-assay-fda-510k.jpg K802623 - EMIT-STM AMPHETAMINE ASSAY K802623 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Nov 1980. https://www.510kdatabase.net/k802624/ 1980-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k802624-emit-stm-urine-calibrators-fda-510k.jpg K802624 - EMIT-STM URINE CALIBRATORS K802624 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Nov 1980. https://www.510kdatabase.net/k802654/ 1980-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k802654-ames-tda-primidone-test-fda-510k.jpg K802654 - AMES TDA PRIMIDONE TEST K802654 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Nov 1980. https://www.510kdatabase.net/k802669/ 1980-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k802669-cybrex-amikacin-fda-510k.jpg K802669 - CYBREX AMIKACIN K802669 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1980. https://www.510kdatabase.net/k802676/ 1980-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k802676-orhtopedic-reamer-87-htd-fda-510k.jpg K802676 - ORHTOPEDIC REAMER 87 HTD K802676 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Zimmer, Inc.. Cleared Nov 1980. https://www.510kdatabase.net/k802677/ 1980-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k802677-closed-endopen-end-colostomy-pch-wcon-fda-510k.jpg K802677 - CLOSED-END/OPEN-END COLOSTOMY PCH. W/CON K802677 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Nov 1980. https://www.510kdatabase.net/k802694/ 1980-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k802694-jacob-chuck-fda-510k.jpg K802694 - JACOB CHUCK K802694 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Nov 1980. https://www.510kdatabase.net/k802751/ 1980-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k802751-p-10-posterior-filling-material-fda-510k.jpg K802751 - P-10 POSTERIOR FILLING MATERIAL K802751 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Nov 1980. https://www.510kdatabase.net/k801055/ 1980-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k801055-compupace-524-01-pacer-system-computer-fda-510k.jpg K801055 - COMPUPACE, 524-01 PACER SYSTEM COMPUTER K801055 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Oct 1980. https://www.510kdatabase.net/k801233/ 1980-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k801233-celltrifuge-ii-fda-510k.jpg K801233 - CELLTRIFUGE II K801233 is a FDA 510(k) cleared hematology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Oct 1980. https://www.510kdatabase.net/k801574/ 1980-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k801574-depalma-elbow-fda-510k.jpg K801574 - DEPALMA ELBOW K801574 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Oct 1980. https://www.510kdatabase.net/k802131/ 1980-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k802131-cybrex-lidocaine-fda-510k.jpg K802131 - CYBREX LIDOCAINE K802131 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1980. https://www.510kdatabase.net/k802137/ 1980-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k802137-cheek-epidural-screw-fda-510k.jpg K802137 - CHEEK EPIDURAL SCREW K802137 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Oct 1980. https://www.510kdatabase.net/k802138/ 1980-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k802138-cheek-tool-set-fda-510k.jpg K802138 - CHEEK TOOL SET K802138 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Oct 1980. https://www.510kdatabase.net/k802171/ 1980-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k802171-kodak-ortho-l-film-fda-510k.jpg K802171 - KODAK ORTHO L FILM K802171 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Oct 1980. https://www.510kdatabase.net/k802293/ 1980-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k802293-polyflex-implantable-pacing-lead-fda-510k.jpg K802293 - POLYFLEX IMPLANTABLE PACING LEAD K802293 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Oct 1980. https://www.510kdatabase.net/k802380/ 1980-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k802380-aria-ii-125-i-cortisol-fda-510k.jpg K802380 - ARIA II 125 I CORTISOL K802380 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1980. https://www.510kdatabase.net/k802398/ 1980-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k802398-electroly-te-chemistry-analyzer-fda-510k.jpg K802398 - ELECTROLY TE CHEMISTRY ANALYZER K802398 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Oct 1980. https://www.510kdatabase.net/k802415/ 1980-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k802415-bhi-agarbhi-broth-biphasic-blood-cltbt-fda-510k.jpg K802415 - BHI AGAR/BHI BROTH BIPHASIC BLOOD CLT.BT K802415 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Oct 1980. https://www.510kdatabase.net/k802433/ 1980-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k802433-bard-male-external-catheter-fda-510k.jpg K802433 - BARD MALE EXTERNAL CATHETER K802433 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 1980. https://www.510kdatabase.net/k802446/ 1980-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k802446-ranawat-esf-total-condylar-knee-fda-510k.jpg K802446 - RANAWAT ESF TOTAL CONDYLAR KNEE K802446 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Oct 1980. https://www.510kdatabase.net/k802615/ 1980-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k802615-emit-stm-opiate-assay-fda-510k.jpg K802615 - EMIT-STM OPIATE ASSAY K802615 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Oct 1980. https://www.510kdatabase.net/k802616/ 1980-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k802616-emit-stm-benzodiazepine-assay-fda-510k.jpg K802616 - EMIT-STM BENZODIAZEPINE ASSAY K802616 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Oct 1980. https://www.510kdatabase.net/k802617/ 1980-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k802617-emit-stm-barbiturate-assay-fda-510k.jpg K802617 - EMIT-STM BARBITURATE ASSAY K802617 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Oct 1980. https://www.510kdatabase.net/k802618/ 1980-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k802618-emit-stm-ethyl-alcohol-urine-controls-fda-510k.jpg K802618 - EMIT-STM ETHYL ALCOHOL URINE CONTROLS K802618 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Oct 1980. https://www.510kdatabase.net/k802619/ 1980-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k802619-drug-detection-system-fda-510k.jpg K802619 - DRUG DETECTION SYSTEM K802619 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Oct 1980. https://www.510kdatabase.net/k802620/ 1980-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k802620-emit-stm-ethyl-alcohol-urine-calibrator-fda-510k.jpg K802620 - EMIT-STM ETHYL ALCOHOL URINE CALIBRATOR K802620 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Oct 1980. https://www.510kdatabase.net/k802621/ 1980-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k802621-emit-stm-ethyl-alcohol-assay-fda-510k.jpg K802621 - EMIT-STM ETHYL ALCOHOL ASSAY K802621 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Oct 1980. https://www.510kdatabase.net/k802629/ 1980-10-31 monthly 0.5 https://www.510kdatabase.net/og-image/k802629-steri-sleeve-fda-510k.jpg K802629 - STERI-SLEEVE K802629 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Oct 1980. https://www.510kdatabase.net/k802038/ 1980-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k802038-phenytoin-reagent-test-kit-fda-510k.jpg K802038 - PHENYTOIN REAGENT TEST KIT K802038 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Oct 1980. https://www.510kdatabase.net/k802039/ 1980-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k802039-phenobarbital-reagent-test-kit-fda-510k.jpg K802039 - PHENOBARBITAL REAGENT TEST KIT K802039 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Oct 1980. https://www.510kdatabase.net/k802045/ 1980-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k802045-ge-scan-capability-catb7815f-fda-510k.jpg K802045 - G.E. SCAN CAPABILITY CAT.#B7815F K802045 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Oct 1980. https://www.510kdatabase.net/k802047/ 1980-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k802047-amx-iii-fda-510k.jpg K802047 - AMX-III K802047 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Oct 1980. https://www.510kdatabase.net/k802190/ 1980-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k802190-model-633a-three-channel-stress-test-fda-510k.jpg K802190 - MODEL 633A THREE CHANNEL STRESS TEST K802190 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Oct 1980. https://www.510kdatabase.net/k802194/ 1980-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k802194-minocycline-30mcg-sensi-disc-fda-510k.jpg K802194 - MINOCYCLINE 30MCG. SENSI DISC K802194 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1980. https://www.510kdatabase.net/k802246/ 1980-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k802246-analyte-t3-uptake-fda-510k.jpg K802246 - ANALYTE T3 UPTAKE K802246 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Oct 1980. https://www.510kdatabase.net/k802286/ 1980-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k802286-argle-latex-penrose-tubing-fda-510k.jpg K802286 - ARGLE LATEX PENROSE TUBING K802286 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sherwood Medical Co.. Cleared Oct 1980. https://www.510kdatabase.net/k802301/ 1980-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k802301-cordis-dow-infusion-pump-fda-510k.jpg K802301 - CORDIS DOW INFUSION PUMP K802301 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cordis Corp.. Cleared Oct 1980. https://www.510kdatabase.net/k802310/ 1980-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k802310-il-total-protein-reagent-fda-510k.jpg K802310 - IL TOTAL PROTEIN REAGENT K802310 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Oct 1980. https://www.510kdatabase.net/k802318/ 1980-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k802318-argyle-silicone-thoracic-catheter-fda-510k.jpg K802318 - ARGYLE SILICONE THORACIC CATHETER K802318 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sherwood Medical Co.. Cleared Oct 1980. https://www.510kdatabase.net/k802371/ 1980-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k802371-uric-acidaldh-fda-510k.jpg K802371 - URIC ACID/ALDH K802371 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Oct 1980. https://www.510kdatabase.net/k802376/ 1980-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k802376-kodak-ekta-chem-clinical-chem-slides-fda-510k.jpg K802376 - KODAK EKTA-CHEM CLINICAL CHEM. SLIDES K802376 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Oct 1980. https://www.510kdatabase.net/k802440/ 1980-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k802440-argyle-compact-chest-drainage-sys-fda-510k.jpg K802440 - ARGYLE COMPACT CHEST DRAINAGE SYS. K802440 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Oct 1980. https://www.510kdatabase.net/k802622/ 1980-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k802622-emit-stm-urine-controls-fda-510k.jpg K802622 - EMIT-STM URINE CONTROLS K802622 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Oct 1980. https://www.510kdatabase.net/k801881/ 1980-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k801881-inpersol-capd-administration-set-fda-510k.jpg K801881 - INPERSOL-CAPD ADMINISTRATION SET K801881 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1980. https://www.510kdatabase.net/k802068/ 1980-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k802068-ultimate-direct-total-bilirubin-contro-fda-510k.jpg K802068 - ULTIMATE DIRECT & TOTAL BILIRUBIN CONTRO K802068 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Oct 1980. https://www.510kdatabase.net/k802095/ 1980-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k802095-gore-tex-vascular-graft-fda-510k.jpg K802095 - GORE-TEX VASCULAR GRAFT K802095 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: W.L. Gore & Associates, Inc.. Cleared Oct 1980. https://www.510kdatabase.net/k802108/ 1980-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k802108-kemtrol-serum-control-normal-fda-510k.jpg K802108 - KEMTROL SERUM CONTROL-NORMAL K802108 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Oct 1980. https://www.510kdatabase.net/k802109/ 1980-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k802109-kemtrol-serum-control-abnormal-fda-510k.jpg K802109 - KEMTROL SERUM CONTROL ABNORMAL K802109 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Oct 1980. https://www.510kdatabase.net/k802136/ 1980-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k802136-delta-test-triglycerides-fda-510k.jpg K802136 - DELTA TEST TRIGLYCERIDES K802136 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1980. https://www.510kdatabase.net/k802141/ 1980-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k802141-ch-60-plus-whole-blood-platelet-control-fda-510k.jpg K802141 - CH-60 PLUS WHOLE BLOOD PLATELET CONTROL K802141 is a FDA 510(k) cleared hematology medical device. Manufacturer: American Dade. Cleared Oct 1980. https://www.510kdatabase.net/k802142/ 1980-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k802142-ch-60-plus-whole-blood-plateletabnornal-fda-510k.jpg K802142 - CH-60 PLUS WHOLE BLOOD PLATELET/ABNORNAL K802142 is a FDA 510(k) cleared hematology medical device. Manufacturer: American Dade. Cleared Oct 1980. https://www.510kdatabase.net/k802143/ 1980-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k802143-ch-60-plus-abnormal-lowblood-platelet-fda-510k.jpg K802143 - CH-60 PLUS /ABNORMAL LOW/BLOOD PLATELET K802143 is a FDA 510(k) cleared hematology medical device. Manufacturer: American Dade. Cleared Oct 1980. https://www.510kdatabase.net/k802222/ 1980-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k802222-anterior-kyphosis-distraction-device-fda-510k.jpg K802222 - ANTERIOR KYPHOSIS DISTRACTION DEVICE K802222 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Oct 1980. https://www.510kdatabase.net/k802233/ 1980-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k802233-glycosylated-hemoglobin-smc-column-fda-510k.jpg K802233 - GLYCOSYLATED HEMOGLOBIN-SMC COLUMN K802233 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Oct 1980. https://www.510kdatabase.net/k802245/ 1980-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k802245-7-tricyclic-antide-pressants-fda-510k.jpg K802245 - 7 TRICYCLIC ANTIDE PRESSANTS K802245 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Oct 1980. https://www.510kdatabase.net/k802305/ 1980-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k802305-mlc-4200-cardiac-output-computer-fda-510k.jpg K802305 - MLC-4200 CARDIAC OUTPUT COMPUTER K802305 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Oct 1980. https://www.510kdatabase.net/k802338/ 1980-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k802338-torque-control-balloon-catheter-fda-510k.jpg K802338 - TORQUE CONTROL BALLOON CATHETER K802338 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Oct 1980. https://www.510kdatabase.net/k802362/ 1980-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k802362-alginate-impression-material-fda-510k.jpg K802362 - ALGINATE IMPRESSION MATERIAL K802362 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Oct 1980. https://www.510kdatabase.net/k801456/ 1980-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k801456-fls-mca-application-software-fda-510k.jpg K801456 - F/LS MCA APPLICATION SOFTWARE K801456 is a FDA 510(k) cleared immunology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Oct 1980. https://www.510kdatabase.net/k801603/ 1980-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k801603-polyethylene-filled-bone-plate-fda-510k.jpg K801603 - POLYETHYLENE FILLED BONE PLATE K801603 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Oct 1980. https://www.510kdatabase.net/k801679/ 1980-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k801679-beta-cap-ii-fda-510k.jpg K801679 - BETA-CAP II K801679 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quinton, Inc.. Cleared Oct 1980. https://www.510kdatabase.net/k802273/ 1980-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k802273-telemetry-transmitter-tlt-3-fda-510k.jpg K802273 - TELEMETRY TRANSMITTER, #TLT-3 K802273 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1980. https://www.510kdatabase.net/k802281/ 1980-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k802281-sherwood-nano-mist-nebulizer-wmouthpiec-fda-510k.jpg K802281 - SHERWOOD NANO-MIST NEBULIZER W/MOUTHPIEC K802281 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sherwood Medical Co.. Cleared Oct 1980. https://www.510kdatabase.net/k800857/ 1980-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k800857-helena-glycosylated-hemoglobin-quik-meth-fda-510k.jpg K800857 - HELENA GLYCOSYLATED HEMOGLOBIN QUIK METH K800857 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Sep 1980. https://www.510kdatabase.net/k800944/ 1980-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k800944-medtronic-model-69575-fda-510k.jpg K800944 - MEDTRONIC MODEL 69575 K800944 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Sep 1980. https://www.510kdatabase.net/k801699/ 1980-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k801699-ethicon-retraction-tape-fda-510k.jpg K801699 - ETHICON RETRACTION TAPE K801699 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Sep 1980. https://www.510kdatabase.net/k802064/ 1980-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k802064-dupont-acalactic-acid-la-test-fda-510k.jpg K802064 - DUPONT ACALACTIC ACID (LA) TEST K802064 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Sep 1980. https://www.510kdatabase.net/k802093/ 1980-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k802093-gabbay-frater-suture-guide-fda-510k.jpg K802093 - GABBAY-FRATER SUTURE GUIDE K802093 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Howmedica Corp.. Cleared Sep 1980. https://www.510kdatabase.net/k802103/ 1980-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k802103-ecg-recall-edit-product-version-a3601-fda-510k.jpg K802103 - ECG RECALL & EDIT PRODUCT VERSION-A3601 K802103 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: General Electric Co.. Cleared Sep 1980. https://www.510kdatabase.net/k802144/ 1980-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k802144-2m8101-heated-liquid-level-controller-fda-510k.jpg K802144 - 2M8101 HEATED LIQUID LEVEL CONTROLLER K802144 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Sep 1980. https://www.510kdatabase.net/k802145/ 1980-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k802145-2c-7140-heated-humidifer-cannister-fda-510k.jpg K802145 - 2C 7140 HEATED HUMIDIFER CANNISTER K802145 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Sep 1980. https://www.510kdatabase.net/k802165/ 1980-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k802165-sherwood-ventilatory-muscle-trainer-fda-510k.jpg K802165 - SHERWOOD VENTILATORY MUSCLE TRAINER K802165 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sherwood Medical Co.. Cleared Sep 1980. https://www.510kdatabase.net/k802174/ 1980-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k802174-argyle-suction-canister-wdisp-liner-fda-510k.jpg K802174 - ARGYLE SUCTION CANISTER W/DISP. LINER K802174 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Sep 1980. https://www.510kdatabase.net/k802235/ 1980-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k802235-micro-bond-hi-life-procelain-vivere-fda-510k.jpg K802235 - MICRO-BOND HI-LIFE PROCELAIN & VIVERE K802235 is a FDA 510(k) cleared dental medical device. Manufacturer: Howmedica Corp.. Cleared Sep 1980. https://www.510kdatabase.net/k802242/ 1980-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k802242-3m-hi-strength-med-tape-1534-fda-510k.jpg K802242 - 3M HI-STRENGTH MED. TAPE #1534 K802242 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3M Company. Cleared Sep 1980. https://www.510kdatabase.net/k802255/ 1980-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k802255-ames-tda-phenobarbital-test-fda-510k.jpg K802255 - AMES TDA PHENOBARBITAL TEST K802255 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Sep 1980. https://www.510kdatabase.net/k801454/ 1980-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k801454-datason-rtl-fda-510k.jpg K801454 - DATASON RTL K801454 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Sep 1980. https://www.510kdatabase.net/k801588/ 1980-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k801588-caulk-prisma-lite-fda-510k.jpg K801588 - CAULK PRISMA-LITE K801588 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Sep 1980. https://www.510kdatabase.net/k801735/ 1980-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k801735-aria-ii-125-i-estriol-system-fda-510k.jpg K801735 - ARIA II 125- I-ESTRIOL SYSTEM K801735 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1980. https://www.510kdatabase.net/k801749/ 1980-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k801749-beckman-astra-systems-total-protein-chem-fda-510k.jpg K801749 - BECKMAN ASTRA SYSTEMS TOTAL PROTEIN CHEM K801749 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Sep 1980. https://www.510kdatabase.net/k801750/ 1980-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k801750-beckman-astra-systems-albumin-chemistry-fda-510k.jpg K801750 - BECKMAN ASTRA SYSTEMS ALBUMIN CHEMISTRY K801750 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Sep 1980. https://www.510kdatabase.net/k801896/ 1980-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k801896-beckman-electrolyte-2-sodiumpotassium-fda-510k.jpg K801896 - BECKMAN ELECTROLYTE-2 SODIUM/POTASSIUM K801896 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Sep 1980. https://www.510kdatabase.net/k801917/ 1980-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k801917-star-fda-510k.jpg K801917 - STAR K801917 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Sep 1980. https://www.510kdatabase.net/k801956/ 1980-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k801956-tissue-tek-iii-tissue-embedding-center-fda-510k.jpg K801956 - TISSUE-TEK III TISSUE EMBEDDING CENTER K801956 is a FDA 510(k) cleared pathology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Sep 1980. https://www.510kdatabase.net/k801979/ 1980-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k801979-argyle-compact-chest-drainage-system-fda-510k.jpg K801979 - ARGYLE COMPACT CHEST DRAINAGE SYSTEM K801979 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Sep 1980. https://www.510kdatabase.net/k802031/ 1980-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k802031-3390a-reporting-integrator-fda-510k.jpg K802031 - 3390A REPORTING INTEGRATOR K802031 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Sep 1980. https://www.510kdatabase.net/k802046/ 1980-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k802046-pds-model-3000-adult-respiration-module-fda-510k.jpg K802046 - PDS MODEL 3000 ADULT RESPIRATION MODULE K802046 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: General Electric Co.. Cleared Sep 1980. https://www.510kdatabase.net/k802079/ 1980-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k802079-deknatel-goosen-vascular-punch-blades-fda-510k.jpg K802079 - DEKNATEL GOOSEN VASCULAR PUNCH BLADES K802079 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Howmedica Corp.. Cleared Sep 1980. https://www.510kdatabase.net/k802119/ 1980-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k802119-shiley-utility-reservoir-fda-510k.jpg K802119 - SHILEY UTILITY RESERVOIR K802119 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Sep 1980. https://www.510kdatabase.net/k802123/ 1980-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k802123-monospherical-shoulder-prosthesis-fda-510k.jpg K802123 - MONOSPHERICAL SHOULDER PROSTHESIS K802123 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Sep 1980. https://www.510kdatabase.net/k802125/ 1980-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k802125-anteriorposterior-composite-restorative-fda-510k.jpg K802125 - ANTERIOR/POSTERIOR COMPOSITE RESTORATIVE K802125 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Sep 1980. https://www.510kdatabase.net/k802147/ 1980-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k802147-shiley-temperature-monitor-fda-510k.jpg K802147 - SHILEY TEMPERATURE MONITOR K802147 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Shiley, Inc.. Cleared Sep 1980. https://www.510kdatabase.net/k802187/ 1980-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k802187-sterile-disposable-cytology-brush-fda-510k.jpg K802187 - STERILE DISPOSABLE CYTOLOGY BRUSH K802187 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Corp.. Cleared Sep 1980. https://www.510kdatabase.net/k800226/ 1980-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k800226-medtronic-model-2409-fda-510k.jpg K800226 - MEDTRONIC MODEL 2409 K800226 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Sep 1980. https://www.510kdatabase.net/k801910/ 1980-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k801910-insulating-sheath-fda-510k.jpg K801910 - INSULATING SHEATH K801910 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Sep 1980. https://www.510kdatabase.net/k801926/ 1980-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k801926-sigma-procedure-880-fibrinoginplasma-fda-510k.jpg K801926 - SIGMA PROCEDURE #880 FIBRINOGIN/PLASMA K801926 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Chemical Co.. Cleared Sep 1980. https://www.510kdatabase.net/k801932/ 1980-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k801932-hep-trol-fda-510k.jpg K801932 - HEP-TROL K801932 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Sep 1980. https://www.510kdatabase.net/k802040/ 1980-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k802040-battery-for-229-01-pulse-generator-fda-510k.jpg K802040 - BATTERY FOR #229-01 PULSE GENERATOR K802040 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Sep 1980. https://www.510kdatabase.net/k801637/ 1980-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k801637-fluoro-mark-radiopaque-anatomical-mkr-fda-510k.jpg K801637 - FLUORO-MARK RADIOPAQUE ANATOMICAL MKR. K801637 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Aug 1980. https://www.510kdatabase.net/k801693/ 1980-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k801693-salmonella-flagellar-a-antigen-b-fda-510k.jpg K801693 - SALMONELLA FLAGELLAR A ANTIGEN & B K801693 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1980. https://www.510kdatabase.net/k801762/ 1980-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k801762-micro-processor-unit-a3600ac-fda-510k.jpg K801762 - MICRO-PROCESSOR UNIT #A3600AC K801762 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: General Electric Co.. Cleared Aug 1980. https://www.510kdatabase.net/k801911/ 1980-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k801911-howmedica-bite-block-fda-510k.jpg K801911 - HOWMEDICA BITE BLOCK K801911 is a FDA 510(k) cleared dental medical device. Manufacturer: Howmedica Corp.. Cleared Aug 1980. https://www.510kdatabase.net/k801969/ 1980-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k801969-asnis-guided-screw-systems-fda-510k.jpg K801969 - ASNIS GUIDED SCREW SYSTEMS K801969 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Howmedica Corp.. Cleared Aug 1980. https://www.510kdatabase.net/k801481/ 1980-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k801481-bmc-riaflo-system-fda-510k.jpg K801481 - BMC RIAFLO SYSTEM K801481 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Aug 1980. https://www.510kdatabase.net/k801649/ 1980-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k801649-kodak-ektachem-clinical-chemistry-slides-fda-510k.jpg K801649 - KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES K801649 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Aug 1980. https://www.510kdatabase.net/k801653/ 1980-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k801653-maxi-camera-37-fda-510k.jpg K801653 - MAXI CAMERA 37 K801653 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Aug 1980. https://www.510kdatabase.net/k801654/ 1980-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k801654-maxi-camera-61-fda-510k.jpg K801654 - MAXI CAMERA 61 K801654 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Aug 1980. https://www.510kdatabase.net/k801663/ 1980-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k801663-seralyzer-glucose-reagent-strips-fda-510k.jpg K801663 - SERALYZER GLUCOSE REAGENT STRIPS K801663 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Aug 1980. https://www.510kdatabase.net/k801664/ 1980-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k801664-seralyzer-glucose-test-module-fda-510k.jpg K801664 - SERALYZER GLUCOSE TEST MODULE K801664 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Aug 1980. https://www.510kdatabase.net/k801665/ 1980-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k801665-seralyzer-glucose-calibratorslowhigh-fda-510k.jpg K801665 - SERALYZER GLUCOSE CALIBRATORS(LOW&HIGH) K801665 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Aug 1980. https://www.510kdatabase.net/k801676/ 1980-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k801676-ferrizyme-ferritin-enzyme-immunoassay-fda-510k.jpg K801676 - FERRIZYME FERRITIN ENZYME IMMUNOASSAY K801676 is a FDA 510(k) cleared immunology medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1980. https://www.510kdatabase.net/k801707/ 1980-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k801707-bk-1499-kay-kplint-hand-conebk-1500-fda-510k.jpg K801707 - BK-1499 KAY-KPLINT HAND CONE/BK-1500 K801707 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Aug 1980. https://www.510kdatabase.net/k801736/ 1980-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k801736-ames-tda-tm-phenytoin-test-fda-510k.jpg K801736 - AMES TDA TM PHENYTOIN TEST K801736 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Aug 1980. https://www.510kdatabase.net/k801761/ 1980-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k801761-pds-computer-unitvideo-terminal-fda-510k.jpg K801761 - PDS COMPUTER UNIT/VIDEO TERMINAL K801761 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: General Electric Co.. Cleared Aug 1980. https://www.510kdatabase.net/k801823/ 1980-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k801823-band-aid-brand-tricot-mesh-bandages-fda-510k.jpg K801823 - BAND-AID BRAND TRICOT MESH BANDAGES K801823 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Aug 1980. https://www.510kdatabase.net/k801824/ 1980-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k801824-band-aid-brand-flexible-fabric-bandage-fda-510k.jpg K801824 - BAND-AID BRAND FLEXIBLE FABRIC BANDAGE K801824 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Aug 1980. https://www.510kdatabase.net/k801865/ 1980-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k801865-cordis-flow-directed-balloon-catheter-fda-510k.jpg K801865 - CORDIS FLOW DIRECTED BALLOON CATHETER K801865 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Aug 1980. https://www.510kdatabase.net/k801928/ 1980-08-20 monthly 0.5 https://www.510kdatabase.net/og-image/k801928-lab-tek-fta-abs-kit-fda-510k.jpg K801928 - LAB-TEK FTA-ABS KIT K801928 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Aug 1980. https://www.510kdatabase.net/k801450/ 1980-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k801450-intermedics-thin-lith-iv-series-unipolar-fda-510k.jpg K801450 - INTERMEDICS THIN LITH IV SERIES UNIPOLAR K801450 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Aug 1980. https://www.510kdatabase.net/k801492/ 1980-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k801492-porphyrin-ala-disk-fda-510k.jpg K801492 - PORPHYRIN (ALA) DISK K801492 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Aug 1980. https://www.510kdatabase.net/k801493/ 1980-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k801493-ala-swab-fda-510k.jpg K801493 - ALA SWAB K801493 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Aug 1980. https://www.510kdatabase.net/k801499/ 1980-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k801499-aga-uv-photometer-fda-510k.jpg K801499 - AGA UV PHOTOMETER K801499 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Aug 1980. https://www.510kdatabase.net/k801580/ 1980-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k801580-ferritin-ria-kit-fda-510k.jpg K801580 - FERRITIN RIA KIT K801580 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Aug 1980. https://www.510kdatabase.net/k801609/ 1980-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k801609-maddox-lens-spatula-cat-7245-fda-510k.jpg K801609 - MADDOX LENS SPATULA CAT. #7245 K801609 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Edward Weck, Inc.. Cleared Aug 1980. https://www.510kdatabase.net/k801618/ 1980-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k801618-argyle-a-v-medi-wing-hemodialysis-set-fda-510k.jpg K801618 - ARGYLE A-V MEDI-WING HEMODIALYSIS SET K801618 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Sherwood Medical Co.. Cleared Aug 1980. https://www.510kdatabase.net/k801648/ 1980-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k801648-trimethroprim-5mcg-sensi-disc-fda-510k.jpg K801648 - TRIMETHROPRIM 5MCG. SENSI DISC. K801648 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1980. https://www.510kdatabase.net/k801660/ 1980-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k801660-proximate-psd-purse-string-device-fda-510k.jpg K801660 - PROXIMATE * PSD PURSE-STRING DEVICE K801660 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Aug 1980. https://www.510kdatabase.net/k801711/ 1980-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k801711-bk-6010-catheter-tube-holder-fda-510k.jpg K801711 - BK-6010 CATHETER TUBE HOLDER K801711 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fred Sammons, Inc.. Cleared Aug 1980. https://www.510kdatabase.net/k801731/ 1980-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k801731-c-dak-duo-flux-artificial-kidney-fda-510k.jpg K801731 - C-DAK DUO-FLUX ARTIFICIAL KIDNEY K801731 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Aug 1980. https://www.510kdatabase.net/k801747/ 1980-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k801747-terumo-fetal-monitor-fhm-602-fda-510k.jpg K801747 - TERUMO FETAL MONITOR # FHM-602 K801747 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Terumo Medical Corp.. Cleared Aug 1980. https://www.510kdatabase.net/k801764/ 1980-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k801764-ionescu-shiley-pericardial-patch-fda-510k.jpg K801764 - IONESCU-SHILEY PERICARDIAL PATCH K801764 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Aug 1980. https://www.510kdatabase.net/k801794/ 1980-08-13 monthly 0.5 https://www.510kdatabase.net/og-image/k801794-elastic-adhesive-bandagessterile-fda-510k.jpg K801794 - ELASTIC ADHESIVE BANDAGES(STERILE) K801794 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Smith & Nephew, Inc.. Cleared Aug 1980. https://www.510kdatabase.net/k800993/ 1980-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k800993-inpersol-capd-admin-set-catheter-adap-fda-510k.jpg K800993 - INPERSOL CAPD ADMIN. SET & CATHETER ADAP K800993 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1980. https://www.510kdatabase.net/k801441/ 1980-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k801441-abbottshaw-life-care-pump-model-3-fda-510k.jpg K801441 - ABBOTT/SHAW LIFE CARE PUMP MODEL 3 K801441 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1980. https://www.510kdatabase.net/k801468/ 1980-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k801468-frazier-ferguson-suction-tubes-fda-510k.jpg K801468 - FRAZIER-FERGUSON SUCTION TUBES K801468 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Edward Weck, Inc.. Cleared Aug 1980. https://www.510kdatabase.net/k801608/ 1980-08-12 monthly 0.5 https://www.510kdatabase.net/og-image/k801608-mcculley-continuous-suture-tightner-fda-510k.jpg K801608 - MCCULLEY CONTINUOUS SUTURE TIGHTNER K801608 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Edward Weck, Inc.. Cleared Aug 1980. https://www.510kdatabase.net/k801677/ 1980-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k801677-electrocardiograph-model-ecg-5503-fda-510k.jpg K801677 - ELECTROCARDIOGRAPH, MODEL ECG-5503 K801677 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Aug 1980. https://www.510kdatabase.net/k801700/ 1980-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k801700-uni-record-i-fda-510k.jpg K801700 - UNI-RECORD I K801700 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1980. https://www.510kdatabase.net/k801701/ 1980-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k801701-bauer-black-rigid-wrist-brace-fda-510k.jpg K801701 - BAUER & BLACK RIGID WRIST BRACE K801701 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1980. https://www.510kdatabase.net/k801705/ 1980-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k801705-bk-1424-inner-lip-plate-ceramic-fda-510k.jpg K801705 - BK-1424 INNER LIP PLATE, CERAMIC K801705 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Aug 1980. https://www.510kdatabase.net/k801706/ 1980-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k801706-bk-1426-00-01-stonybrookhi-wall-plate-fda-510k.jpg K801706 - BK-1426-00-01 STONYBROOK/HI-WALL PLATE K801706 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Aug 1980. https://www.510kdatabase.net/k801708/ 1980-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k801708-bk-1520-01-economy-wrist-support-child-fda-510k.jpg K801708 - BK-1520-01 ECONOMY WRIST SUPPORT, CHILD K801708 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Aug 1980. https://www.510kdatabase.net/k801709/ 1980-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k801709-bk-5058-01-quad-quip-wheelchair-cuff-fda-510k.jpg K801709 - BK-5058-01 QUAD-QUIP WHEELCHAIR CUFF K801709 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Aug 1980. https://www.510kdatabase.net/k801710/ 1980-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k801710-bk-5315-01-foam-hand-exerciser-small-fda-510k.jpg K801710 - BK-5315-01 FOAM HAND EXERCISER, SMALL K801710 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Aug 1980. https://www.510kdatabase.net/k801712/ 1980-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k801712-lumbosacral-supports-thoraco-lumbo-sac-fda-510k.jpg K801712 - LUMBOSACRAL SUPPORTS & THORACO-LUMBO-SAC K801712 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Aug 1980. https://www.510kdatabase.net/k801713/ 1980-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k801713-bk-6157-02-cva-sling-mediumlarge-fda-510k.jpg K801713 - BK-6157-02 C.V.A SLING, MEDIUM&LARGE K801713 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Aug 1980. https://www.510kdatabase.net/k801714/ 1980-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k801714-trans-distal-joint-finger-exten-splint-fda-510k.jpg K801714 - TRANS DISTAL JOINT FINGER EXTEN. SPLINT K801714 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Aug 1980. https://www.510kdatabase.net/k801732/ 1980-08-07 monthly 0.5 https://www.510kdatabase.net/og-image/k801732-prisma-fil-fda-510k.jpg K801732 - PRISMA-FIL K801732 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Aug 1980. https://www.510kdatabase.net/k801157/ 1980-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k801157-weber-mayo-wrist-fda-510k.jpg K801157 - WEBER-MAYO WRIST K801157 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Aug 1980. https://www.510kdatabase.net/k801589/ 1980-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k801589-auto-suture-disp-30-etc-surg-stap-fda-510k.jpg K801589 - AUTO SUTURE DISP. 30, ETC. & SURG. STAP K801589 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Aug 1980. https://www.510kdatabase.net/k801590/ 1980-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k801590-auto-suture-disposable-gia-surg-stapler-fda-510k.jpg K801590 - AUTO SUTURE DISPOSABLE GIA SURG. STAPLER K801590 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Aug 1980. https://www.510kdatabase.net/k801610/ 1980-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k801610-childrens-hospital-pediatric-retractor-fda-510k.jpg K801610 - CHILDREN'S HOSPITAL PEDIATRIC RETRACTOR K801610 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Aug 1980. https://www.510kdatabase.net/k801611/ 1980-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k801611-deep-balfour-blade-for-wilkinson-retract-fda-510k.jpg K801611 - DEEP BALFOUR BLADE FOR WILKINSON RETRACT K801611 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Aug 1980. https://www.510kdatabase.net/k801612/ 1980-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k801612-frazier-ferguson-suction-tubes-disp-fda-510k.jpg K801612 - FRAZIER-FERGUSON SUCTION TUBES (DISP.) K801612 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Aug 1980. https://www.510kdatabase.net/k801680/ 1980-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k801680-beta-cap-ii-adapter-fda-510k.jpg K801680 - BETA-CAP II ADAPTER K801680 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Quinton, Inc.. Cleared Aug 1980. https://www.510kdatabase.net/k801715/ 1980-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k801715-bk-7497-bulb-dynamometer-fda-510k.jpg K801715 - BK-7497 BULB DYNAMOMETER K801715 is a FDA 510(k) cleared neurology medical device. Manufacturer: Fred Sammons, Inc.. Cleared Aug 1980. https://www.510kdatabase.net/k801716/ 1980-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k801716-bk-7505-radiopaque-goniometer-8-fda-510k.jpg K801716 - BK-7505 RADIOPAQUE GONIOMETER, 8 K801716 is a FDA 510(k) cleared neurology medical device. Manufacturer: Fred Sammons, Inc.. Cleared Aug 1980. https://www.510kdatabase.net/k801717/ 1980-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k801717-bk-7511-brass-goniometer-fda-510k.jpg K801717 - BK-7511 BRASS GONIOMETER K801717 is a FDA 510(k) cleared neurology medical device. Manufacturer: Fred Sammons, Inc.. Cleared Aug 1980. https://www.510kdatabase.net/k801718/ 1980-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k801718-bk-7513-stainless-steel-goniometer-fda-510k.jpg K801718 - BK-7513 STAINLESS STEEL GONIOMETER K801718 is a FDA 510(k) cleared neurology medical device. Manufacturer: Fred Sammons, Inc.. Cleared Aug 1980. https://www.510kdatabase.net/k801719/ 1980-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k801719-bk-7531-pain-thresholdfinger-force-gaug-fda-510k.jpg K801719 - BK-7531 PAIN THRESHOLD/FINGER FORCE GAUG K801719 is a FDA 510(k) cleared neurology medical device. Manufacturer: Fred Sammons, Inc.. Cleared Aug 1980. https://www.510kdatabase.net/k801031/ 1980-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k801031-blade-septostomy-catheter-fda-510k.jpg K801031 - BLADE SEPTOSTOMY CATHETER K801031 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Jul 1980. https://www.510kdatabase.net/k801388/ 1980-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k801388-oh-harris-fda-510k.jpg K801388 - OH-HARRIS K801388 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jul 1980. https://www.510kdatabase.net/k801407/ 1980-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k801407-synerview-model-6545-fda-510k.jpg K801407 - SYNERVIEW MODEL 6545 K801407 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Jul 1980. https://www.510kdatabase.net/k801408/ 1980-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k801408-cinescope-iii-fda-510k.jpg K801408 - CINESCOPE III K801408 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Jul 1980. https://www.510kdatabase.net/k801426/ 1980-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k801426-tissue-tek-iii-microject-disp-blade-sys-fda-510k.jpg K801426 - TISSUE-TEK III MICROJECT DISP. BLADE SYS K801426 is a FDA 510(k) cleared pathology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Jul 1980. https://www.510kdatabase.net/k801427/ 1980-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k801427-tissue-tek-iii-mini-rapid-processor-fda-510k.jpg K801427 - TISSUE-TEK III MINI-RAPID PROCESSOR K801427 is a FDA 510(k) cleared pathology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Jul 1980. https://www.510kdatabase.net/k801465/ 1980-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k801465-gaskin-fragment-forcepsmfg-non-sterile-fda-510k.jpg K801465 - GASKIN FRAGMENT FORCEPS(MFG. NON-STERILE K801465 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Edward Weck, Inc.. Cleared Jul 1980. https://www.510kdatabase.net/k801466/ 1980-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k801466-leigh-measuring-scale-7725-fda-510k.jpg K801466 - LEIGH MEASURING SCALE #7725 K801466 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Edward Weck, Inc.. Cleared Jul 1980. https://www.510kdatabase.net/k801467/ 1980-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k801467-dodick-lens-holding-forceps-fda-510k.jpg K801467 - DODICK LENS HOLDING FORCEPS K801467 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Edward Weck, Inc.. Cleared Jul 1980. https://www.510kdatabase.net/k801469/ 1980-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k801469-bonn-micro-iris-hook-non-sterile-7613-fda-510k.jpg K801469 - BONN MICRO IRIS HOOK (NON-STERILE) #7613 K801469 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Edward Weck, Inc.. Cleared Jul 1980. https://www.510kdatabase.net/k801471/ 1980-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k801471-super-banish-deodorant-fda-510k.jpg K801471 - SUPER BANISH DEODORANT K801471 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Howmedica Corp.. Cleared Jul 1980. https://www.510kdatabase.net/k801511/ 1980-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k801511-naso-gard-nasogastric-tube-holder-fda-510k.jpg K801511 - NASO-GARD NASOGASTRIC TUBE HOLDER K801511 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Howmedica Corp.. Cleared Jul 1980. https://www.510kdatabase.net/k801522/ 1980-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k801522-argyle-rigid-urine-measuringcoll-dev-fda-510k.jpg K801522 - ARGYLE RIGID URINE MEASURING/COLL. DEV. K801522 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Sherwood Medical Co.. Cleared Jul 1980. https://www.510kdatabase.net/k800805/ 1980-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k800805-linear-array-scanner-fda-510k.jpg K800805 - LINEAR ARRAY SCANNER K800805 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Jul 1980. https://www.510kdatabase.net/k801039/ 1980-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k801039-adaptaid-helical-coil-adapter-365-14-fda-510k.jpg K801039 - ADAPTAID HELICAL COIL ADAPTER 365-14 K801039 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Jul 1980. https://www.510kdatabase.net/k801305/ 1980-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k801305-hippurate-disk-fda-510k.jpg K801305 - HIPPURATE DISK K801305 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Jul 1980. https://www.510kdatabase.net/k801320/ 1980-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k801320-sfx-90-tablespotfilmer-wfluoricon-l200-fda-510k.jpg K801320 - SFX-90 TABLE/SPOTFILMER W/FLUORICON L200 K801320 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jul 1980. https://www.510kdatabase.net/k801368/ 1980-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k801368-a2-image-processing-system-fda-510k.jpg K801368 - A2 IMAGE PROCESSING SYSTEM K801368 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medtronic Vascular. Cleared Jul 1980. https://www.510kdatabase.net/k801548/ 1980-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k801548-perf-lock-impression-tray-fda-510k.jpg K801548 - PERF-LOCK IMPRESSION TRAY K801548 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jul 1980. https://www.510kdatabase.net/k801551/ 1980-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k801551-argyle-saf-t-mark-suction-catheter-fda-510k.jpg K801551 - ARGYLE SAF-T-MARK SUCTION CATHETER K801551 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sherwood Medical Co.. Cleared Jul 1980. https://www.510kdatabase.net/k801565/ 1980-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k801565-cybrex-phenytoin-fda-510k.jpg K801565 - CYBREX PHENYTOIN K801565 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Jul 1980. https://www.510kdatabase.net/k801566/ 1980-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k801566-cybrex-phenobarbital-fda-510k.jpg K801566 - CYBREX PHENOBARBITAL K801566 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Jul 1980. https://www.510kdatabase.net/k801567/ 1980-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k801567-cybrex-theophylline-fda-510k.jpg K801567 - CYBREX THEOPHYLLINE K801567 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Jul 1980. https://www.510kdatabase.net/k801587/ 1980-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k801587-ash-blueprint-alginate-impression-mater-fda-510k.jpg K801587 - ASH BLUEPRINT ALGINATE IMPRESSION MATER. K801587 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jul 1980. https://www.510kdatabase.net/k800624/ 1980-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k800624-low-acetate-hemodialysis-bath-concentr-fda-510k.jpg K800624 - LOW-ACETATE HEMODIALYSIS BATH CONCENTR. K800624 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Jul 1980. https://www.510kdatabase.net/k800627/ 1980-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k800627-ambulatory-infusion-pump-code-2m9807-fda-510k.jpg K800627 - AMBULATORY INFUSION PUMP, CODE 2M9807 K800627 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Jul 1980. https://www.510kdatabase.net/k801318/ 1980-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k801318-helena-ultra-sensitive-cpk-reagentdilue-fda-510k.jpg K801318 - HELENA ULTRA SENSITIVE CPK REAGENT/DILUE K801318 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Jul 1980. https://www.510kdatabase.net/k801360/ 1980-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k801360-cardiotomy-reservoir-with-filter-fda-510k.jpg K801360 - CARDIOTOMY RESERVOIR WITH FILTER K801360 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Jul 1980. https://www.510kdatabase.net/k801373/ 1980-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k801373-beckman-model-42-spectrophotometer-fda-510k.jpg K801373 - BECKMAN MODEL 42 SPECTROPHOTOMETER K801373 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jul 1980. https://www.510kdatabase.net/k801375/ 1980-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k801375-shiley-cardiotomy-reservoir-wfilter-fda-510k.jpg K801375 - SHILEY CARDIOTOMY RESERVOIR W/FILTER K801375 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Jul 1980. https://www.510kdatabase.net/k801391/ 1980-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k801391-disc-120-transporter-fda-510k.jpg K801391 - DISC 120 TRANSPORTER K801391 is a FDA 510(k) cleared immunology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Jul 1980. https://www.510kdatabase.net/k801409/ 1980-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k801409-gammadab-b-hcg-radioimmunoassay-kit-fda-510k.jpg K801409 - GAMMADAB B-HCG RADIOIMMUNOASSAY KIT K801409 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Jul 1980. https://www.510kdatabase.net/k801444/ 1980-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k801444-skin-staple-remover-523770-fda-510k.jpg K801444 - SKIN STAPLE REMOVER #523770 K801444 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Jul 1980. https://www.510kdatabase.net/k801445/ 1980-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k801445-skin-stapler-handle-523700cartridges-fda-510k.jpg K801445 - SKIN STAPLER HANDLE 523700/CARTRIDGES K801445 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Jul 1980. https://www.510kdatabase.net/k801452/ 1980-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k801452-orotracheal-intubation-endoscope-fda-510k.jpg K801452 - OROTRACHEAL INTUBATION ENDOSCOPE K801452 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Olympus Corp.. Cleared Jul 1980. https://www.510kdatabase.net/k801457/ 1980-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k801457-accu-core-disposable-biopsy-needle-fda-510k.jpg K801457 - ACCU-CORE DISPOSABLE BIOPSY NEEDLE K801457 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medline Industries, Inc.. Cleared Jul 1980. https://www.510kdatabase.net/k801470/ 1980-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k801470-micro-clip-sterilizing-case-65199-fda-510k.jpg K801470 - MICRO CLIP STERILIZING CASE #65199 K801470 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Jul 1980. https://www.510kdatabase.net/k800803/ 1980-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k800803-nitrate-swab-rapid-test-fda-510k.jpg K800803 - NITRATE SWAB-RAPID TEST K800803 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Jul 1980. https://www.510kdatabase.net/k801020/ 1980-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k801020-gamma-prolactin-radioimmunoassay-kit--fda-510k.jpg K801020 - GAMMA PROLACTIN RADIOIMMUNOASSAY KIT- K801020 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Jul 1980. https://www.510kdatabase.net/k801038/ 1980-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k801038-adaptaid-elema-lead-adapter-kit-365-17-fda-510k.jpg K801038 - ADAPTAID ELEMA LEAD ADAPTER KIT 365-17 K801038 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Jul 1980. https://www.510kdatabase.net/k801106/ 1980-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k801106-multicor-gamma-model-336-model-337-fda-510k.jpg K801106 - MULTICOR (GAMMA) MODEL 336 & MODEL 337 K801106 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Jul 1980. https://www.510kdatabase.net/k801269/ 1980-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k801269-seralyzer-blood-urea-nitrogenbun-fda-510k.jpg K801269 - SERALYZER BLOOD UREA NITROGEN(BUN) K801269 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Jul 1980. https://www.510kdatabase.net/k801270/ 1980-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k801270-test-for-ketone-in-urineacetoacetic-ac-fda-510k.jpg K801270 - TEST FOR KETONE IN URINE(ACETOACETIC AC K801270 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Jul 1980. https://www.510kdatabase.net/k801300/ 1980-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k801300-dupont-aca-conjugated-bilirubincbil-fda-510k.jpg K801300 - DUPONT 'ACA' CONJUGATED BILIRUBIN(CBIL) K801300 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Jul 1980. https://www.510kdatabase.net/k801352/ 1980-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k801352-hemorrhoidal-ligation-instr-system-fda-510k.jpg K801352 - HEMORRHOIDAL LIGATION INSTR. SYSTEM K801352 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Depuy, Inc.. Cleared Jul 1980. https://www.510kdatabase.net/k801354/ 1980-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k801354-bionics-arterialvenous-fistula-needle-fda-510k.jpg K801354 - BIONICS ARTERIAL/VENOUS FISTULA NEEDLE K801354 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Jul 1980. https://www.510kdatabase.net/k801355/ 1980-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k801355-bionics-bi-flo-stretchdouble-lumen-for-fda-510k.jpg K801355 - BIONICS BI-FLO STRETCH(DOUBLE LUMEN FOR K801355 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Jul 1980. https://www.510kdatabase.net/k801356/ 1980-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k801356-bionics-bi-flo-safedouble-lumen-cathet-fda-510k.jpg K801356 - BIONICS BI-FLO SAFE(DOUBLE LUMEN CATHET K801356 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Jul 1980. https://www.510kdatabase.net/k801384/ 1980-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k801384-myelostat-dorsal-cord-stimulator-etc-fda-510k.jpg K801384 - MYELOSTAT DORSAL CORD STIMULATOR, ETC. K801384 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Jul 1980. https://www.510kdatabase.net/k801475/ 1980-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k801475-application-of-emit-aed-assays-fda-510k.jpg K801475 - APPLICATION OF EMIT AED ASSAYS K801475 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jul 1980. https://www.510kdatabase.net/k801476/ 1980-07-08 monthly 0.5 https://www.510kdatabase.net/og-image/k801476-application-of-emit-theophylline-assay-fda-510k.jpg K801476 - APPLICATION OF EMIT THEOPHYLLINE ASSAY K801476 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jul 1980. https://www.510kdatabase.net/k801040/ 1980-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k801040-ge-lead-adapter-model-345-01-fda-510k.jpg K801040 - GE LEAD ADAPTER, MODEL 345-01 K801040 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Jun 1980. https://www.510kdatabase.net/k801287/ 1980-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k801287-emit-aaii-thyroxine-calibrators-fda-510k.jpg K801287 - EMIT AAII THYROXINE CALIBRATORS K801287 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Jun 1980. https://www.510kdatabase.net/k801288/ 1980-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k801288-emit-aaii-thyroxine-assay-fda-510k.jpg K801288 - EMIT AAII THYROXINE ASSAY K801288 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Jun 1980. https://www.510kdatabase.net/k800069/ 1980-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k800069-medtronic-models-59665967-etc-fda-510k.jpg K800069 - MEDTRONIC MODELS 5966/5967, ETC. K800069 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jun 1980. https://www.510kdatabase.net/k801209/ 1980-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k801209-kodak-medical-x-ray-developer-replen-fda-510k.jpg K801209 - KODAK MEDICAL X-RAY DEVELOPER & REPLEN. K801209 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Jun 1980. https://www.510kdatabase.net/k801371/ 1980-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k801371-argyle-vac-u-care-flat-silicone-wound-t-fda-510k.jpg K801371 - ARGYLE VAC-U-CARE FLAT SILICONE WOUND T. K801371 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sherwood Medical Co.. Cleared Jun 1980. https://www.510kdatabase.net/k801372/ 1980-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k801372-argyle-vac-u-care-100cc-suct-reservoir-fda-510k.jpg K801372 - ARGYLE VAC-U-CARE 100CC SUCT. RESERVOIR K801372 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sherwood Medical Co.. Cleared Jun 1980. https://www.510kdatabase.net/k801374/ 1980-06-26 monthly 0.5 https://www.510kdatabase.net/og-image/k801374-proximate-tmd-tissue-measuring-device-fda-510k.jpg K801374 - PROXIMATE (TMD) TISSUE MEASURING DEVICE K801374 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Jun 1980. https://www.510kdatabase.net/k800797/ 1980-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k800797-macro-vue-rubella-card-test-fda-510k.jpg K800797 - MACRO-VUE RUBELLA CARD TEST K800797 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jun 1980. https://www.510kdatabase.net/k800911/ 1980-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k800911-a-gent-thyrozyme-uptake-inhibitor-assay-fda-510k.jpg K800911 - A-GENT THYROZYME UPTAKE INHIBITOR ASSAY K800911 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1980. https://www.510kdatabase.net/k801154/ 1980-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k801154-proximateils-disp-intraluminal-stap-fda-510k.jpg K801154 - PROXIMATE*(ILS) DISP. INTRALUMINAL STAP. K801154 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Jun 1980. https://www.510kdatabase.net/k801207/ 1980-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k801207-emit-valproic-acid-assay-fda-510k.jpg K801207 - EMIT VALPROIC ACID ASSAY K801207 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jun 1980. https://www.510kdatabase.net/k801276/ 1980-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k801276-dupont-prep-appli-for-phenobarbital-fda-510k.jpg K801276 - DUPONT PREP APPLI. FOR PHENOBARBITAL, K801276 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Jun 1980. https://www.510kdatabase.net/k801343/ 1980-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k801343-b-d-filter-needle-fda-510k.jpg K801343 - B-D FILTER NEEDLE K801343 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jun 1980. https://www.510kdatabase.net/k801057/ 1980-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k801057-3m-steam-sterilization-indicator-fda-510k.jpg K801057 - 3M STEAM STERILIZATION INDICATOR K801057 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Jun 1980. https://www.510kdatabase.net/k801124/ 1980-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k801124-nylon-ligating-clip-fda-510k.jpg K801124 - NYLON LIGATING CLIP K801124 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Jun 1980. https://www.510kdatabase.net/k801206/ 1980-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k801206-emit-valproic-acid-control-fda-510k.jpg K801206 - EMIT VALPROIC ACID CONTROL K801206 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jun 1980. https://www.510kdatabase.net/k801210/ 1980-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k801210-biostator-printerplotter-fda-510k.jpg K801210 - BIOSTATOR PRINTER/PLOTTER K801210 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Jun 1980. https://www.510kdatabase.net/k801155/ 1980-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k801155-technicon-h6000-hematology-system-fda-510k.jpg K801155 - TECHNICON H6000 HEMATOLOGY SYSTEM K801155 is a FDA 510(k) cleared hematology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Jun 1980. https://www.510kdatabase.net/k801204/ 1980-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k801204-emit-disopyramide-assay-fda-510k.jpg K801204 - EMIT DISOPYRAMIDE ASSAY K801204 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Jun 1980. https://www.510kdatabase.net/k801205/ 1980-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k801205-emit-disopyramide-control-fda-510k.jpg K801205 - EMIT DISOPYRAMIDE CONTROL K801205 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jun 1980. https://www.510kdatabase.net/k801313/ 1980-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k801313-compression-molding-of-uhmwpe-fda-510k.jpg K801313 - COMPRESSION MOLDING OF UHMWPE K801313 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jun 1980. https://www.510kdatabase.net/k792300/ 1980-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k792300-lifeline-tle-traebecular-lodging-elec-fda-510k.jpg K792300 - LIFELINE TLE (TRAEBECULAR LODGING ELEC K792300 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Jun 1980. https://www.510kdatabase.net/k792301/ 1980-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k792301-lifeline-tle-j-shaped-atrial-endocardial-fda-510k.jpg K792301 - LIFELINE TLE J-SHAPED ATRIAL ENDOCARDIAL K792301 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Jun 1980. https://www.510kdatabase.net/k800725/ 1980-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k800725-a-gent-quantichrom-thrombigen-i-fda-510k.jpg K800725 - A-GENT QUANTICHROM THROMBIGEN I K800725 is a FDA 510(k) cleared hematology medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1980. https://www.510kdatabase.net/k801200/ 1980-06-04 monthly 0.5 https://www.510kdatabase.net/og-image/k801200-sampling-manifold-h530-fda-510k.jpg K801200 - SAMPLING MANIFOLD H530 K801200 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jun 1980. https://www.510kdatabase.net/k801044/ 1980-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k801044-ames-glucometer-reflect-photometer-fda-510k.jpg K801044 - AMES GLUCOMETER REFLECT. PHOTOMETER K801044 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Jun 1980. https://www.510kdatabase.net/k800656/ 1980-05-30 monthly 0.5 https://www.510kdatabase.net/og-image/k800656-a-gent-quantichrom-thrombigen-e-fda-510k.jpg K800656 - A-GENT QUANTICHROM THROMBIGEN-E K800656 is a FDA 510(k) cleared hematology medical device. Manufacturer: Abbott Laboratories. Cleared May 1980. https://www.510kdatabase.net/k801000/ 1980-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k801000-large-screen-crt-display-1311b-fda-510k.jpg K801000 - LARGE SCREEN CRT DISPLAY #1311B K801000 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared May 1980. https://www.510kdatabase.net/k801026/ 1980-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k801026-il-model-773-fluorescence-light-scatter-fda-510k.jpg K801026 - IL MODEL 773 FLUORESCENCE LIGHT SCATTER K801026 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared May 1980. https://www.510kdatabase.net/k801027/ 1980-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k801027-mds-imager-fda-510k.jpg K801027 - MDS IMAGER K801027 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medtronic Vascular. Cleared May 1980. https://www.510kdatabase.net/k801130/ 1980-05-28 monthly 0.5 https://www.510kdatabase.net/og-image/k801130-ames-tda-amikacin-fda-510k.jpg K801130 - AMES TDA AMIKACIN K801130 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared May 1980. https://www.510kdatabase.net/k800899/ 1980-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k800899-lab-tek-anacult-anaerobic-culture-chambe-fda-510k.jpg K800899 - LAB-TEK ANACULT ANAEROBIC CULTURE CHAMBE K800899 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared May 1980. https://www.510kdatabase.net/k801041/ 1980-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k801041-3m-rf-current-suppressor-fda-510k.jpg K801041 - 3M R.F. CURRENT SUPPRESSOR K801041 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: 3M Company. Cleared May 1980. https://www.510kdatabase.net/k801084/ 1980-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k801084-cybrex-gentamicin-fda-510k.jpg K801084 - CYBREX GENTAMICIN K801084 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared May 1980. https://www.510kdatabase.net/k801131/ 1980-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k801131-il88640-88641-cassette-tape-program-fda-510k.jpg K801131 - IL88640 & 88641 CASSETTE-TAPE PROGRAM K801131 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared May 1980. https://www.510kdatabase.net/k801156/ 1980-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k801156-usci-intraluminal-graft-wdacron-tie-fda-510k.jpg K801156 - USCI INTRALUMINAL GRAFT W/DACRON TIE K801156 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 1980. https://www.510kdatabase.net/k800285/ 1980-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k800285-model-5985-pacemaker-pulse-generator-fda-510k.jpg K800285 - MODEL 5985 PACEMAKER PULSE GENERATOR K800285 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared May 1980. https://www.510kdatabase.net/k800901/ 1980-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k800901-kodak-ektaspeed-dental-x-ray-film-fda-510k.jpg K800901 - KODAK EKTASPEED DENTAL X-RAY FILM K800901 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared May 1980. https://www.510kdatabase.net/k801080/ 1980-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k801080-edwards-rod-sleeves-fda-510k.jpg K801080 - EDWARDS ROD SLEEVES K801080 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared May 1980. https://www.510kdatabase.net/k801092/ 1980-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k801092-prisma-fill-fda-510k.jpg K801092 - PRISMA-FILL K801092 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared May 1980. https://www.510kdatabase.net/k801093/ 1980-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k801093-prisma-bond-fda-510k.jpg K801093 - PRISMA-BOND K801093 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared May 1980. https://www.510kdatabase.net/k801120/ 1980-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k801120-dunn-anterior-distraction-system-fda-510k.jpg K801120 - DUNN ANTERIOR DISTRACTION SYSTEM K801120 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared May 1980. https://www.510kdatabase.net/k800629/ 1980-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k800629-intravenous-infusion-pump-code-2m8015-fda-510k.jpg K800629 - INTRAVENOUS INFUSION PUMP, CODE 2M8015 K800629 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared May 1980. https://www.510kdatabase.net/k800639/ 1980-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k800639-orbitor-fda-510k.jpg K800639 - ORBITOR K800639 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared May 1980. https://www.510kdatabase.net/k800788/ 1980-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k800788-siregraph-c-fda-510k.jpg K800788 - SIREGRAPH C K800788 is a FDA 510(k) cleared radiology medical device. Manufacturer: Siemens Medical Solutions USA, Inc.. Cleared May 1980. https://www.510kdatabase.net/k801007/ 1980-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k801007-il-system-502-nak-analyzer-fda-510k.jpg K801007 - IL SYSTEM 502 NA/K ANALYZER K801007 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared May 1980. https://www.510kdatabase.net/k800668/ 1980-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k800668-cannula-wsharp-obturator-veress-need-fda-510k.jpg K800668 - CANNULA, W/SHARP OBTURATOR & VERESS NEED K800668 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared May 1980. https://www.510kdatabase.net/k800704/ 1980-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k800704-c-dak-tm-2800-artificial-kidney-fda-510k.jpg K800704 - C-DAK TM 2800 ARTIFICIAL KIDNEY K800704 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared May 1980. https://www.510kdatabase.net/k800711/ 1980-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k800711-volumetric-pump-cassette-wattached-set-fda-510k.jpg K800711 - VOLUMETRIC PUMP CASSETTE W/ATTACHED SET K800711 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared May 1980. https://www.510kdatabase.net/k800721/ 1980-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k800721-general-utility-surg-scissors-460180--fda-510k.jpg K800721 - GENERAL UTILITY SURG. SCISSORS #460180- K800721 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Edward Weck, Inc.. Cleared May 1980. https://www.510kdatabase.net/k800734/ 1980-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k800734-rapid-fermentation-agar-rfa-fda-510k.jpg K800734 - RAPID FERMENTATION AGAR (RFA) K800734 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared May 1980. https://www.510kdatabase.net/k800916/ 1980-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k800916-p1-blood-group-substance-fda-510k.jpg K800916 - P1 BLOOD GROUP SUBSTANCE K800916 is a FDA 510(k) cleared hematology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared May 1980. https://www.510kdatabase.net/k800943/ 1980-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k800943-pentex-bovine-albumin-30-solution-fda-510k.jpg K800943 - PENTEX BOVINE ALBUMIN 30% SOLUTION K800943 is a FDA 510(k) cleared hematology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared May 1980. https://www.510kdatabase.net/k800991/ 1980-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k800991-cordia-n-fda-510k.jpg K800991 - CORDIA N K800991 is a FDA 510(k) cleared immunology medical device. Manufacturer: Cordis Corp.. Cleared May 1980. https://www.510kdatabase.net/k800992/ 1980-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k800992-cordia-np-fda-510k.jpg K800992 - CORDIA NP K800992 is a FDA 510(k) cleared immunology medical device. Manufacturer: Cordis Corp.. Cleared May 1980. https://www.510kdatabase.net/k792089/ 1980-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k792089-the-howmedica-kinematic-knee-system-fda-510k.jpg K792089 - THE HOWMEDICA KINEMATIC KNEE SYSTEM K792089 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared May 1980. https://www.510kdatabase.net/k800433/ 1980-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k800433-helena-colocheck-fda-510k.jpg K800433 - HELENA COLOCHECK K800433 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared May 1980. https://www.510kdatabase.net/k800484/ 1980-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k800484-mod-3127-neuromuscular-stimulator-fda-510k.jpg K800484 - MOD. 3127 NEUROMUSCULAR STIMULATOR K800484 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Medtronic Vascular. Cleared May 1980. https://www.510kdatabase.net/k800564/ 1980-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k800564-general-electric-radview-mark-i-system-fda-510k.jpg K800564 - GENERAL ELECTRIC RADVIEW MARK I SYSTEM K800564 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared May 1980. https://www.510kdatabase.net/k800745/ 1980-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k800745-cellibiose-arginine-lysine-agar-cal-fda-510k.jpg K800745 - CELLIBIOSE-ARGININE-LYSINE AGAR (CAL) K800745 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared May 1980. https://www.510kdatabase.net/k800852/ 1980-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k800852-hemespec-check-set-fda-510k.jpg K800852 - HEMESPEC CHECK SET K800852 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared May 1980. https://www.510kdatabase.net/k800894/ 1980-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k800894-dupuy-cement-restrictor-trials-instr-fda-510k.jpg K800894 - DUPUY CEMENT RESTRICTOR TRIALS & INSTR. K800894 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared May 1980. https://www.510kdatabase.net/k800994/ 1980-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k800994-austry-alloydental-bake-on-alloy-fda-510k.jpg K800994 - AUSTRY ALLOY(DENTAL BAKE-ON ALLOY) K800994 is a FDA 510(k) cleared dental medical device. Manufacturer: Howmedica Corp.. Cleared May 1980. https://www.510kdatabase.net/k800487/ 1980-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k800487-3m-titanium-alloy-total-hip-system-32mm-fda-510k.jpg K800487 - 3M TITANIUM ALLOY TOTAL HIP SYSTEM 32MM K800487 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 3M Company. Cleared Apr 1980. https://www.510kdatabase.net/k800853/ 1980-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k800853-asa2-lyophilized-hemo-control-fda-510k.jpg K800853 - A,SA2 LYOPHILIZED HEMO CONTROL K800853 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Apr 1980. https://www.510kdatabase.net/k800854/ 1980-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k800854-aa2-lyophilized-hemo-control-fda-510k.jpg K800854 - A,A2 LYOPHILIZED HEMO CONTROL K800854 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Apr 1980. https://www.510kdatabase.net/k800855/ 1980-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k800855-afsc-lyophilized-hemo-control-fda-510k.jpg K800855 - A,FSC LYOPHILIZED HEMO CONTROL K800855 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Apr 1980. https://www.510kdatabase.net/k800856/ 1980-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k800856-afda2-lyophilized-hemo-control-fda-510k.jpg K800856 - A,FDA2 LYOPHILIZED HEMO CONTROL K800856 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Apr 1980. https://www.510kdatabase.net/k800910/ 1980-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k800910-gal-put-controls-normaldeficient-fda-510k.jpg K800910 - GAL-PUT CONTROLS, NORMAL&DEFICIENT K800910 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Apr 1980. https://www.510kdatabase.net/k800753/ 1980-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k800753-sterile-water-saline-in-plastic-btl-fda-510k.jpg K800753 - STERILE WATER & SALINE IN PLASTIC BTL. K800753 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Apr 1980. https://www.510kdatabase.net/k800796/ 1980-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k800796-gas-pak-ii-dis-generator-envelopes-fda-510k.jpg K800796 - GAS PAK II DIS. GENERATOR ENVELOPES K800796 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1980. https://www.510kdatabase.net/k800798/ 1980-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k800798-human-thyroid-stim-hormonearia-ii-fda-510k.jpg K800798 - HUMAN THYROID STIM. HORMONE/ARIA II K800798 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1980. https://www.510kdatabase.net/k800813/ 1980-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k800813-diagnostic-products-corp-ria-control-fda-510k.jpg K800813 - DIAGNOSTIC PRODUCTS CORP. RIA CONTROL K800813 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Apr 1980. https://www.510kdatabase.net/k800848/ 1980-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k800848-seralyzer-uric-acid-reagent-strips--fda-510k.jpg K800848 - SERALYZER URIC ACID REAGENT STRIPS - K800848 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Apr 1980. https://www.510kdatabase.net/k800895/ 1980-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k800895-model-253-11-cyberlith-pulse-generator-fda-510k.jpg K800895 - MODEL 253-11 CYBERLITH PULSE GENERATOR K800895 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Apr 1980. https://www.510kdatabase.net/k800669/ 1980-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k800669-feldman-mini-saw-300000-fda-510k.jpg K800669 - FELDMAN MINI-SAW, #300000 K800669 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: KARL STORZ Endoscopy-America, Inc.. Cleared Apr 1980. https://www.510kdatabase.net/k800757/ 1980-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k800757-il-model-1303-phblood-gas-analyzer-fda-510k.jpg K800757 - IL MODEL 1303 PH/BLOOD GAS ANALYZER K800757 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Apr 1980. https://www.510kdatabase.net/k800806/ 1980-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k800806-ics-mini-small-fragment-set-fda-510k.jpg K800806 - I.C.S. MINI & SMALL FRAGMENT SET K800806 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Apr 1980. https://www.510kdatabase.net/k800298/ 1980-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k800298-usci-bipolar-ballon-pacing-electrode-fda-510k.jpg K800298 - USCI BIPOLAR BALLON PACING ELECTRODE K800298 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 1980. https://www.510kdatabase.net/k800570/ 1980-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k800570-heparin-pump-7420-fda-510k.jpg K800570 - HEPARIN PUMP #7420 K800570 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1980. https://www.510kdatabase.net/k800600/ 1980-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k800600-b-d-staset-iv-flow-controller-fda-510k.jpg K800600 - B-D STASET, I.V. FLOW CONTROLLER K800600 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1980. https://www.510kdatabase.net/k800644/ 1980-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k800644-cyberlith-implantable-pulse-gen-253-02-fda-510k.jpg K800644 - CYBERLITH IMPLANTABLE PULSE GEN. #253-02 K800644 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Apr 1980. https://www.510kdatabase.net/k800647/ 1980-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k800647-norsen-debrider-fda-510k.jpg K800647 - NORSEN DEBRIDER K800647 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medline Industries, Inc.. Cleared Apr 1980. https://www.510kdatabase.net/k800724/ 1980-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k800724-ames-lab-management-system-fda-510k.jpg K800724 - AMES LAB MANAGEMENT SYSTEM K800724 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Apr 1980. https://www.510kdatabase.net/k800554/ 1980-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k800554-multi-format-sfd-model-1720-fda-510k.jpg K800554 - MULTI-FORMAT SFD MODEL 1720 K800554 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Apr 1980. https://www.510kdatabase.net/k800604/ 1980-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k800604-ck-isoenzyme-electrophoresis-control-id-fda-510k.jpg K800604 - CK ISOENZYME ELECTROPHORESIS CONTROL-I.D K800604 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Apr 1980. https://www.510kdatabase.net/k800628/ 1980-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k800628-kodak-ektachem-clinical-chem-slides-fda-510k.jpg K800628 - KODAK EKTACHEM CLINICAL CHEM. SLIDES K800628 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Apr 1980. https://www.510kdatabase.net/k800646/ 1980-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k800646-ames-tda-theophyl-line-test-fda-510k.jpg K800646 - AMES TDA THEOPHYL-LINE TEST K800646 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Apr 1980. https://www.510kdatabase.net/k800758/ 1980-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k800758-tenzcare-dual-channel-stimulator-fda-510k.jpg K800758 - TENZCARE DUAL-CHANNEL STIMULATOR K800758 is a FDA 510(k) cleared neurology medical device. Manufacturer: 3M Company. Cleared Apr 1980. https://www.510kdatabase.net/k791496/ 1980-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k791496-low-plasticizer-administration-sets-fda-510k.jpg K791496 - LOW PLASTICIZER ADMINISTRATION SETS K791496 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Apr 1980. https://www.510kdatabase.net/k800330/ 1980-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k800330-model-7200-hemodialysis-delivery-system-fda-510k.jpg K800330 - MODEL 7200 HEMODIALYSIS DELIVERY SYSTEM K800330 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1980. https://www.510kdatabase.net/k800539/ 1980-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k800539-disp-hydrogen-co2-generator-envelope-fda-510k.jpg K800539 - DISP. HYDROGEN & CO2 GENERATOR ENVELOPE K800539 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1980. https://www.510kdatabase.net/k800645/ 1980-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k800645-cyberlith-implantable-pulse-gen-253-04-fda-510k.jpg K800645 - CYBERLITH IMPLANTABLE PULSE GEN. #253-04 K800645 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Apr 1980. https://www.510kdatabase.net/k800059/ 1980-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k800059-compur-m-1000-mini-photometer-fda-510k.jpg K800059 - COMPUR M-1000 MINI-PHOTOMETER K800059 is a FDA 510(k) cleared hematology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Apr 1980. https://www.510kdatabase.net/k800533/ 1980-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k800533-add-of-reticulocyte-countcapabilities-fda-510k.jpg K800533 - ADD OF RETICULOCYTE COUNT/CAPABILITIES K800533 is a FDA 510(k) cleared hematology medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1980. https://www.510kdatabase.net/k800535/ 1980-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k800535-3m-disposable-skin-stapler-fda-510k.jpg K800535 - 3M DISPOSABLE SKIN STAPLER K800535 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3M Company. Cleared Apr 1980. https://www.510kdatabase.net/k800541/ 1980-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k800541-campylobacter-agar-w5-antimicrobics-fda-510k.jpg K800541 - CAMPYLOBACTER AGAR W/5-ANTIMICROBICS K800541 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1980. https://www.510kdatabase.net/k800524/ 1980-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k800524-seralyzer-reflectance-photometercalib-fda-510k.jpg K800524 - SERALYZER REFLECTANCE PHOTOMETER/CALIB. K800524 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Apr 1980. https://www.510kdatabase.net/k800540/ 1980-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k800540-cinoxacin-100-mcg-sensi-disc-fda-510k.jpg K800540 - CINOXACIN 100 MCG SENSI DISC K800540 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1980. https://www.510kdatabase.net/k800432/ 1980-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k800432-helena-ristocetin-fda-510k.jpg K800432 - HELENA RISTOCETIN K800432 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Mar 1980. https://www.510kdatabase.net/k800556/ 1980-03-25 monthly 0.5 https://www.510kdatabase.net/og-image/k800556-differential-refractive-index-detector-fda-510k.jpg K800556 - DIFFERENTIAL REFRACTIVE INDEX DETECTOR K800556 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Mar 1980. https://www.510kdatabase.net/k800137/ 1980-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k800137-pri-piggyback-iv-wdual-piercing-pin-fda-510k.jpg K800137 - PRI. PIGGYBACK I.V. W/DUAL PIERCING PIN K800137 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1980. https://www.510kdatabase.net/k800457/ 1980-03-20 monthly 0.5 https://www.510kdatabase.net/og-image/k800457-liquid-stat-liquid-reagent-fda-510k.jpg K800457 - LIQUID-STAT LIQUID REAGENT K800457 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Mar 1980. https://www.510kdatabase.net/k792675/ 1980-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k792675-charcoal-yeast-extractcye-agar-fda-510k.jpg K792675 - CHARCOAL YEAST EXTRACT(CYE) AGAR K792675 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Mar 1980. https://www.510kdatabase.net/k800203/ 1980-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k800203-ria-phase-t4-fda-510k.jpg K800203 - RIA PHASE T4 K800203 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Mar 1980. https://www.510kdatabase.net/k800204/ 1980-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k800204-ria-phase-tbg-fda-510k.jpg K800204 - RIA PHASE TBG K800204 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Mar 1980. https://www.510kdatabase.net/k800205/ 1980-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k800205-ria-phase-digoxin-fda-510k.jpg K800205 - RIA PHASE DIGOXIN K800205 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Mar 1980. https://www.510kdatabase.net/k800287/ 1980-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k800287-ceph-lactam-disk-fda-510k.jpg K800287 - CEPH LACTAM DISK K800287 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Mar 1980. https://www.510kdatabase.net/k800384/ 1980-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k800384-smac-system-t4-method-fda-510k.jpg K800384 - SMAC SYSTEM, T4 METHOD K800384 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Mar 1980. https://www.510kdatabase.net/k800385/ 1980-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k800385-analyte-t4-thyroxine-fda-510k.jpg K800385 - ANALYTE T4-THYROXINE K800385 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Mar 1980. https://www.510kdatabase.net/k800426/ 1980-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k800426-tryptic-soy-brothtsb-wc02-1-yeast-fda-510k.jpg K800426 - TRYPTIC SOY BROTH(TSB) W/C02 & 1% YEAST K800426 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1980. https://www.510kdatabase.net/k800427/ 1980-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k800427-tryptic-soy-broth-wc02sps1-yeast-ext-fda-510k.jpg K800427 - TRYPTIC SOY BROTH W/C02,SPS&1% YEAST EXT K800427 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1980. https://www.510kdatabase.net/k800428/ 1980-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k800428-tryptic-soy-broth-wcysteine-and-fda-510k.jpg K800428 - TRYPTIC SOY BROTH W/CYSTEINE AND K800428 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1980. https://www.510kdatabase.net/k800429/ 1980-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k800429-tryptic-soy-broth-wc02cysteine-1-fda-510k.jpg K800429 - TRYPTIC SOY BROTH W/C02,CYSTEINE & 1% K800429 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1980. https://www.510kdatabase.net/k800436/ 1980-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k800436-t3-solid-phase-radioimmunoassay-kit-fda-510k.jpg K800436 - T3 SOLID PHASE RADIOIMMUNOASSAY KIT K800436 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1980. https://www.510kdatabase.net/k800516/ 1980-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k800516-dupont-instruments-model-870-liq-chrom-fda-510k.jpg K800516 - DUPONT INSTRUMENTS MODEL 870 LIQ. CHROM. K800516 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Mar 1980. https://www.510kdatabase.net/k800485/ 1980-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k800485-vinyl-polysiloxane-impression-material-fda-510k.jpg K800485 - VINYL POLYSILOXANE IMPRESSION MATERIAL K800485 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Mar 1980. https://www.510kdatabase.net/k800494/ 1980-03-18 monthly 0.5 https://www.510kdatabase.net/og-image/k800494-new-jersey-hemiarthroplasty-sholder-pros-fda-510k.jpg K800494 - NEW JERSEY HEMIARTHROPLASTY SHOLDER PROS K800494 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Mar 1980. https://www.510kdatabase.net/k800166/ 1980-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k800166-dentsply-denture-cleaner-fda-510k.jpg K800166 - DENTSPLY DENTURE CLEANER K800166 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Mar 1980. https://www.510kdatabase.net/k800368/ 1980-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k800368-ophthalmic-forceps-fda-510k.jpg K800368 - OPHTHALMIC FORCEPS K800368 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Edward Weck, Inc.. Cleared Mar 1980. https://www.510kdatabase.net/k800400/ 1980-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k800400-maxum-denture-resin-fda-510k.jpg K800400 - MAXUM DENTURE RESIN K800400 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Mar 1980. https://www.510kdatabase.net/k792050/ 1980-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k792050-3m-small-volume-infustion-svi-system-fda-510k.jpg K792050 - 3M SMALL VOLUME INFUSTION (SVI) SYSTEM K792050 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Mar 1980. https://www.510kdatabase.net/k800294/ 1980-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k800294-045-sodium-chloride-solresp-therapy-fda-510k.jpg K800294 - 0.45% SODIUM CHLORIDE SOL./RESP. THERAPY K800294 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1980. https://www.510kdatabase.net/k800295/ 1980-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k800295-09-sodium-chloride-solresp-therapy-fda-510k.jpg K800295 - 0.9% SODIUM CHLORIDE SOL./RESP. THERAPY K800295 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1980. https://www.510kdatabase.net/k800318/ 1980-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k800318-doubletime-2-tipped-appliers-for-hemocli-fda-510k.jpg K800318 - DOUBLETIME 2-TIPPED APPLIERS FOR HEMOCLI K800318 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Mar 1980. https://www.510kdatabase.net/k800367/ 1980-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k800367-micresurgical-tray-smmed-lg-fda-510k.jpg K800367 - MICRESURGICAL TRAY, SM.,MED., & LG. K800367 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Mar 1980. https://www.510kdatabase.net/k800004/ 1980-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k800004-ecg-monitor-oscilloscope-model-oec-3200-fda-510k.jpg K800004 - ECG MONITOR OSCILLOSCOPE MODEL OEC-3200 K800004 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Mar 1980. https://www.510kdatabase.net/k800005/ 1980-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k800005-ecg-monitor-oscilloscope-model-oec-3100-fda-510k.jpg K800005 - ECG MONITOR OSCILLOSCOPE MODEL OEC-3100 K800005 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Mar 1980. https://www.510kdatabase.net/k800282/ 1980-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k800282-data-management-system-il-model-775-fda-510k.jpg K800282 - DATA MANAGEMENT SYSTEM IL MODEL 775 K800282 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Mar 1980. https://www.510kdatabase.net/k800301/ 1980-03-05 monthly 0.5 https://www.510kdatabase.net/og-image/k800301-sigma-procedure-reagent-system-335-uv-fda-510k.jpg K800301 - SIGMA PROCEDURE & REAGENT SYSTEM #335-UV K800301 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Mar 1980. https://www.510kdatabase.net/k800206/ 1980-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k800206-aca-choleserolhdl-cholesterol-calibrat-fda-510k.jpg K800206 - ACA CHOLESEROL/HDL CHOLESTEROL CALIBRAT. K800206 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Mar 1980. https://www.510kdatabase.net/k800245/ 1980-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k800245-emit-auto-cortisol-assay-fda-510k.jpg K800245 - EMIT AUTO CORTISOL ASSAY K800245 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Mar 1980. https://www.510kdatabase.net/k800149/ 1980-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k800149-usci-sauvage-exs-vascular-prosthesis-fda-510k.jpg K800149 - USCI SAUVAGE EXS VASCULAR PROSTHESIS K800149 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Feb 1980. https://www.510kdatabase.net/k800386/ 1980-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k800386-argyle-tru-vol-fda-510k.jpg K800386 - ARGYLE TRU-VOL K800386 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sherwood Medical Co.. Cleared Feb 1980. https://www.510kdatabase.net/k800221/ 1980-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k800221-cf211-capillary-flow-dialyzer-5m1784-fda-510k.jpg K800221 - CF/211 CAPILLARY FLOW DIALYZER, #5M1784 K800221 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Feb 1980. https://www.510kdatabase.net/k800246/ 1980-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k800246-emit-dau-cannabinoid-urine-assay-fda-510k.jpg K800246 - EMIT -D.A.U. CANNABINOID URINE ASSAY K800246 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Feb 1980. https://www.510kdatabase.net/k800247/ 1980-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k800247-emit-dau-cannabinoid-urine-calibs-fda-510k.jpg K800247 - EMIT -D.A.U. CANNABINOID URINE CALIBS. K800247 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Feb 1980. https://www.510kdatabase.net/k800284/ 1980-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k800284-three-way-stopcock-extension-set-20-sl-fda-510k.jpg K800284 - THREE-WAY STOPCOCK EXTENSION SET 20-SL K800284 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Feb 1980. https://www.510kdatabase.net/k800175/ 1980-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k800175-nasostat-fda-510k.jpg K800175 - NASOSTAT K800175 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Edward Weck, Inc.. Cleared Feb 1980. https://www.510kdatabase.net/k800268/ 1980-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k800268-automated-rhematoid-factor-test-arft-fda-510k.jpg K800268 - AUTOMATED RHEMATOID FACTOR TEST (ARFT) K800268 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Feb 1980. https://www.510kdatabase.net/k800142/ 1980-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k800142-fuson-bone-plug-radiopaque-fda-510k.jpg K800142 - FUSON BONE PLUG, RADIOPAQUE K800142 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Feb 1980. https://www.510kdatabase.net/k800143/ 1980-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k800143-dynamic-extensor-splint-fda-510k.jpg K800143 - DYNAMIC EXTENSOR SPLINT K800143 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Biomet, Inc.. Cleared Feb 1980. https://www.510kdatabase.net/k800144/ 1980-02-19 monthly 0.5 https://www.510kdatabase.net/og-image/k800144-femoral-cement-restrictor-fda-510k.jpg K800144 - FEMORAL CEMENT RESTRICTOR K800144 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Feb 1980. https://www.510kdatabase.net/k800141/ 1980-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k800141-accustroke-pipet-fda-510k.jpg K800141 - ACCUSTROKE PIPET K800141 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Feb 1980. https://www.510kdatabase.net/k800169/ 1980-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k800169-ames-rialyze-chromatography-tubes-fda-510k.jpg K800169 - AMES RIALYZE - CHROMATOGRAPHY TUBES K800169 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Feb 1980. https://www.510kdatabase.net/k800170/ 1980-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k800170-ames-rialyze-uptake-chrom-tubes-fda-510k.jpg K800170 - AMES RIALYZE - UPTAKE CHROM. TUBES K800170 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Feb 1980. https://www.510kdatabase.net/k792669/ 1980-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k792669-corometrics-push-button-spiral-electrode-fda-510k.jpg K792669 - COROMETRICS-PUSH BUTTON SPIRAL ELECTRODE K792669 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Feb 1980. https://www.510kdatabase.net/k800207/ 1980-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k800207-uhr-universal6hip-replacement-fda-510k.jpg K800207 - UHR UNIVERSAL6HIP REPLACEMENT K800207 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Osteonics Corp.. Cleared Feb 1980. https://www.510kdatabase.net/k792651/ 1980-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k792651-capd-transfer-set-jc9044-fda-510k.jpg K792651 - CAPD TRANSFER SET JC9044 K792651 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Feb 1980. https://www.510kdatabase.net/k800054/ 1980-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k800054-kodak-ektachem-electrolyte-analyzer-fda-510k.jpg K800054 - KODAK EKTACHEM ELECTROLYTE ANALYZER K800054 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Feb 1980. https://www.510kdatabase.net/k800121/ 1980-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k800121-technicon-c90-system-fda-510k.jpg K800121 - TECHNICON C/90 SYSTEM K800121 is a FDA 510(k) cleared hematology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Feb 1980. https://www.510kdatabase.net/k800150/ 1980-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k800150-emit-tobramycin-assay-fda-510k.jpg K800150 - EMIT TOBRAMYCIN ASSAY K800150 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Feb 1980. https://www.510kdatabase.net/k800151/ 1980-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k800151-emit-tobramycin-control-fda-510k.jpg K800151 - EMIT TOBRAMYCIN CONTROL K800151 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Feb 1980. https://www.510kdatabase.net/k800193/ 1980-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k800193-medtronic-pisces-generation-ii-lead-kit-fda-510k.jpg K800193 - MEDTRONIC PISCES GENERATION II LEAD KIT K800193 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Feb 1980. https://www.510kdatabase.net/k792541/ 1980-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k792541-monoject-plastic-dental-inj-syringe-fda-510k.jpg K792541 - MONOJECT PLASTIC DENTAL INJ. SYRINGE K792541 is a FDA 510(k) cleared dental medical device. Manufacturer: Sherwood Medical Co.. Cleared Feb 1980. https://www.510kdatabase.net/k792650/ 1980-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k792650-hamas-precentered-total-wrist-fda-510k.jpg K792650 - HAMAS PRECENTERED TOTAL WRIST K792650 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jan 1980. https://www.510kdatabase.net/k800074/ 1980-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k800074-vessel-occluder-fda-510k.jpg K800074 - VESSEL OCCLUDER K800074 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Cordis Corp.. Cleared Jan 1980. https://www.510kdatabase.net/k800079/ 1980-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k800079-hemoclip-surgical-occluding-clip-fda-510k.jpg K800079 - HEMOCLIP SURGICAL OCCLUDING CLIP K800079 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Jan 1980. https://www.510kdatabase.net/k800080/ 1980-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k800080-sterilizing-case-cat-no-65199-fda-510k.jpg K800080 - STERILIZING CASE CAT. NO. 65199 K800080 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Edward Weck, Inc.. Cleared Jan 1980. https://www.510kdatabase.net/k792655/ 1980-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k792655-helena-coloscreen-fda-510k.jpg K792655 - HELENA COLOSCREEN K792655 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Jan 1980. https://www.510kdatabase.net/k792656/ 1980-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k792656-helena-factor-xii-deficient-fda-510k.jpg K792656 - HELENA FACTOR XII DEFICIENT K792656 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Jan 1980. https://www.510kdatabase.net/k792676/ 1980-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k792676-campy-thio-fda-510k.jpg K792676 - CAMPY THIO K792676 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Jan 1980. https://www.510kdatabase.net/k800056/ 1980-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k800056-ventilator-set-fda-510k.jpg K800056 - VENTILATOR SET K800056 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Abbott Laboratories. Cleared Jan 1980. https://www.510kdatabase.net/k800083/ 1980-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k800083-nebulizer-tubing-set-fda-510k.jpg K800083 - NEBULIZER TUBING SET K800083 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Abbott Laboratories. Cleared Jan 1980. https://www.510kdatabase.net/k800045/ 1980-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k800045-quantimune-cortisol-ria-cortisol-radio--fda-510k.jpg K800045 - QUANTIMUNE CORTISOL RIA CORTISOL RADIO- K800045 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Jan 1980. https://www.510kdatabase.net/k800049/ 1980-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k800049-delta-test-amylase-uv-fda-510k.jpg K800049 - DELTA TEST AMYLASE UV K800049 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jan 1980. https://www.510kdatabase.net/k800053/ 1980-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k800053-kodak-ektachem-four-chemistry-analyzer-fda-510k.jpg K800053 - KODAK EKTACHEM FOUR CHEMISTRY ANALYZER K800053 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Eastman Kodak Company. Cleared Jan 1980. https://www.510kdatabase.net/k800090/ 1980-01-23 monthly 0.5 https://www.510kdatabase.net/og-image/k800090-fluoromatic-phenolbarbital-fia-fda-510k.jpg K800090 - FLUOROMATIC PHENOLBARBITAL FIA K800090 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bio-Rad. Cleared Jan 1980. https://www.510kdatabase.net/k792585/ 1980-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k792585-smv-120-sonic-mammographic-viewer-fda-510k.jpg K792585 - SMV 120 SONIC MAMMOGRAPHIC VIEWER K792585 is a FDA 510(k) cleared radiology medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jan 1980. https://www.510kdatabase.net/k800016/ 1980-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k800016-dupont-aca-ion-selective-electrode-fda-510k.jpg K800016 - DUPONT ACA ION SELECTIVE ELECTRODE K800016 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Jan 1980. https://www.510kdatabase.net/k800017/ 1980-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k800017-color-coded-putty-soft-regular-firm-fda-510k.jpg K800017 - COLOR CODED PUTTY SOFT, REGULAR & FIRM K800017 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jan 1980. https://www.510kdatabase.net/k800018/ 1980-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k800018-bk-5203-facilitation-vibrator-electric-fda-510k.jpg K800018 - BK-5203 FACILITATION VIBRATOR ELECTRIC K800018 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jan 1980. https://www.510kdatabase.net/k800019/ 1980-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k800019-bk-1544-be-ok-scoop-disk-fda-510k.jpg K800019 - BK-1544 BE OK SCOOP DISK K800019 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jan 1980. https://www.510kdatabase.net/k800035/ 1980-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k800035-pentex-lipoprotein-cholesterol-solu-fda-510k.jpg K800035 - PENTEX LIPOPROTEIN CHOLESTEROL SOLU. K800035 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Jan 1980. https://www.510kdatabase.net/k792439/ 1980-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k792439-analyte-cortisol-fda-510k.jpg K792439 - ANALYTE CORTISOL K792439 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Jan 1980. https://www.510kdatabase.net/k792228/ 1980-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k792228-vented-iv-set-fda-510k.jpg K792228 - VENTED I.V. SET K792228 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Jan 1980. https://www.510kdatabase.net/k792419/ 1980-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k792419-c-dak-2100-artificial-kidney-fda-510k.jpg K792419 - C-DAK 2100 ARTIFICIAL KIDNEY K792419 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Jan 1980. https://www.510kdatabase.net/k792581/ 1980-01-16 monthly 0.5 https://www.510kdatabase.net/og-image/k792581-general-electric-panelipse-ld-fda-510k.jpg K792581 - GENERAL ELECTRIC PANELIPSE LD K792581 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jan 1980. https://www.510kdatabase.net/k792509/ 1980-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k792509-aca-high-density-lipoprotein-choles-fda-510k.jpg K792509 - ACA HIGH DENSITY LIPOPROTEIN CHOLES. K792509 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Jan 1980. https://www.510kdatabase.net/k792588/ 1980-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k792588-territin-ria-kit-fda-510k.jpg K792588 - TERRITIN RIA KIT K792588 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jan 1980. https://www.510kdatabase.net/k792640/ 1980-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k792640-fluoromatic-phenytoin-fia-fda-510k.jpg K792640 - FLUOROMATIC PHENYTOIN FIA K792640 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bio-Rad. Cleared Jan 1980. https://www.510kdatabase.net/k792178/ 1980-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k792178-kodak-cfn-film-so-224-fda-510k.jpg K792178 - KODAK CFN FILM SO-224 K792178 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Jan 1980. https://www.510kdatabase.net/k792293/ 1980-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k792293-kodak-ortho-g-film-fda-510k.jpg K792293 - KODAK ORTHO G FILM K792293 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Jan 1980. https://www.510kdatabase.net/k792317/ 1980-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k792317-sr-301-medical-x-ray-film-fda-510k.jpg K792317 - SR 301 MEDICAL X-RAY FILM K792317 is a FDA 510(k) cleared radiology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Jan 1980. https://www.510kdatabase.net/k792434/ 1980-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k792434-kodak-x-omat-m20-processor-model-2-fda-510k.jpg K792434 - KODAK X-OMAT M20 PROCESSOR, MODEL 2 K792434 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Jan 1980. https://www.510kdatabase.net/k792435/ 1980-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k792435-kodak-x-omat-m20-processor-model-1-fda-510k.jpg K792435 - KODAK X-OMAT M20 PROCESSOR, MODEL 1 K792435 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Jan 1980. https://www.510kdatabase.net/k792448/ 1980-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k792448-kodak-x-omat-g-film-fda-510k.jpg K792448 - KODAK X-OMAT G FILM K792448 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Jan 1980. https://www.510kdatabase.net/k792517/ 1980-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k792517-kodak-x-omat-rp-film-fda-510k.jpg K792517 - KODAK X-OMAT RP FILM K792517 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Jan 1980. https://www.510kdatabase.net/k792678/ 1980-01-09 monthly 0.5 https://www.510kdatabase.net/og-image/k792678-cardiac-output-computer-m-mlc-4100-fda-510k.jpg K792678 - CARDIAC OUTPUT COMPUTER, M-MLC-4100 K792678 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Jan 1980. https://www.510kdatabase.net/k792245/ 1980-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k792245-teeth-denture-plastic-fda-510k.jpg K792245 - TEETH, DENTURE, PLASTIC K792245 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jan 1980. https://www.510kdatabase.net/k792475/ 1979-12-31 monthly 0.5 https://www.510kdatabase.net/og-image/k792475-helena-factor-ix-deficient-substrate-fda-510k.jpg K792475 - HELENA FACTOR IX DEFICIENT SUBSTRATE K792475 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Dec 1979. https://www.510kdatabase.net/k792476/ 1979-12-31 monthly 0.5 https://www.510kdatabase.net/og-image/k792476-helena-factor-xi-deficient-substrate-fda-510k.jpg K792476 - HELENA FACTOR XI DEFICIENT SUBSTRATE K792476 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Dec 1979. https://www.510kdatabase.net/k792507/ 1979-12-31 monthly 0.5 https://www.510kdatabase.net/og-image/k792507-helena-factor-v-deficient-substrate-fda-510k.jpg K792507 - HELENA FACTOR V DEFICIENT SUBSTRATE K792507 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Dec 1979. https://www.510kdatabase.net/k792508/ 1979-12-31 monthly 0.5 https://www.510kdatabase.net/og-image/k792508-helena-factor-x-deficient-substrate-fda-510k.jpg K792508 - HELENA FACTOR X DEFICIENT SUBSTRATE K792508 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Dec 1979. https://www.510kdatabase.net/k792511/ 1979-12-31 monthly 0.5 https://www.510kdatabase.net/og-image/k792511-helena-factor-vii-deficient-sub-plasma-fda-510k.jpg K792511 - HELENA FACTOR VII DEFICIENT SUB. PLASMA K792511 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Dec 1979. https://www.510kdatabase.net/k792584/ 1979-12-31 monthly 0.5 https://www.510kdatabase.net/og-image/k792584-aca-ethosurimide-test-pack-fda-510k.jpg K792584 - ACA ETHOSURIMIDE TEST PACK K792584 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Dec 1979. https://www.510kdatabase.net/k792586/ 1979-12-31 monthly 0.5 https://www.510kdatabase.net/og-image/k792586-halo-support-jacket-assoc-hardware-fda-510k.jpg K792586 - HALO SUPPORT JACKET & ASSOC. HARDWARE K792586 is a FDA 510(k) cleared neurology medical device. Manufacturer: Depuy, Inc.. Cleared Dec 1979. https://www.510kdatabase.net/k792604/ 1979-12-31 monthly 0.5 https://www.510kdatabase.net/og-image/k792604-lifeline-tle-endocardial-pacing-lead-fda-510k.jpg K792604 - LIFELINE TLE ENDOCARDIAL PACING LEAD, K792604 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Dec 1979. https://www.510kdatabase.net/k792336/ 1979-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k792336-helena-factor-ii-deficient-sub-plasma-fda-510k.jpg K792336 - HELENA FACTOR II DEFICIENT SUB. PLASMA K792336 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Dec 1979. https://www.510kdatabase.net/k792353/ 1979-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k792353-intra-articulated-edger-planer-system-fda-510k.jpg K792353 - INTRA-ARTICULATED EDGER-PLANER SYSTEM K792353 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Dec 1979. https://www.510kdatabase.net/k792575/ 1979-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k792575-bactec-bacterial-detection-system-fda-510k.jpg K792575 - BACTEC BACTERIAL DETECTION SYSTEM K792575 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Dec 1979. https://www.510kdatabase.net/k792538/ 1979-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k792538-continu-flo-admin-set-code-2c200-fda-510k.jpg K792538 - CONTINU-FLO ADMIN. SET CODE 2C/200 K792538 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Dec 1979. https://www.510kdatabase.net/k791915/ 1979-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k791915-white-sealing-cap-fda-510k.jpg K791915 - WHITE SEALING CAP K791915 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Dec 1979. https://www.510kdatabase.net/k792276/ 1979-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k792276-brain-heart-infusion-wpaba-o1-fda-510k.jpg K792276 - BRAIN HEART INFUSION W/PABA, O.1%, K792276 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Dec 1979. https://www.510kdatabase.net/k792576/ 1979-12-19 monthly 0.5 https://www.510kdatabase.net/og-image/k792576-castroviejo-vascular-scissors-fda-510k.jpg K792576 - CASTROVIEJO VASCULAR SCISSORS K792576 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edward Weck, Inc.. Cleared Dec 1979. https://www.510kdatabase.net/k792222/ 1979-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k792222-shiley-low-pressure-thin-cuffed-trach-fda-510k.jpg K792222 - SHILEY LOW PRESSURE THIN-CUFFED TRACH. K792222 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Shiley, Inc.. Cleared Dec 1979. https://www.510kdatabase.net/k792328/ 1979-12-18 monthly 0.5 https://www.510kdatabase.net/og-image/k792328-stattek-bun-fda-510k.jpg K792328 - STATTEK BUN K792328 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Dec 1979. https://www.510kdatabase.net/k791782/ 1979-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k791782-usci-balloon-dilatation-inflation-dev-fda-510k.jpg K791782 - USCI BALLOON DILATATION INFLATION DEV. K791782 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 1979. https://www.510kdatabase.net/k791793/ 1979-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k791793-usci-pressure-gauge-fda-510k.jpg K791793 - USCI PRESSURE GAUGE K791793 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 1979. https://www.510kdatabase.net/k792067/ 1979-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k792067-vtx-ge-cataolg-no-b7005a-fda-510k.jpg K792067 - VTX (GE CATAOLG NO. B7005A) K792067 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Dec 1979. https://www.510kdatabase.net/k792123/ 1979-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k792123-kodak-lanex-med-screen-fda-510k.jpg K792123 - KODAK LANEX MED. SCREEN K792123 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Dec 1979. https://www.510kdatabase.net/k792156/ 1979-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k792156-lancer-specimen-container-fda-510k.jpg K792156 - LANCER SPECIMEN CONTAINER K792156 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Dec 1979. https://www.510kdatabase.net/k792381/ 1979-12-10 monthly 0.5 https://www.510kdatabase.net/og-image/k792381-bongort-odor-barrier-drain-fda-510k.jpg K792381 - BONGORT ODOR BARRIER DRAIN K792381 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Howmedica Corp.. Cleared Dec 1979. https://www.510kdatabase.net/k792235/ 1979-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k792235-coagulase-plasma-fda-510k.jpg K792235 - COAGULASE PLASMA K792235 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Dec 1979. https://www.510kdatabase.net/k792205/ 1979-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k792205-seidel-intramedullary-plug-fda-510k.jpg K792205 - SEIDEL INTRAMEDULLARY PLUG K792205 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Dec 1979. https://www.510kdatabase.net/k792285/ 1979-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k792285-technicon-c800-system-fda-510k.jpg K792285 - TECHNICON C800 SYSTEM K792285 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Dec 1979. https://www.510kdatabase.net/k792291/ 1979-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k792291-synthes-reconstructive-plates-y-plates-fda-510k.jpg K792291 - SYNTHES RECONSTRUCTIVE PLATES 'Y' PLATES K792291 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Dec 1979. https://www.510kdatabase.net/k792292/ 1979-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k792292-ames-dextrometer-reflectance-colorimeter-fda-510k.jpg K792292 - AMES DEXTROMETER REFLECTANCE COLORIMETER K792292 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Dec 1979. https://www.510kdatabase.net/k792378/ 1979-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k792378-hemospenser-cartridge-cat-no-523500--fda-510k.jpg K792378 - HEMOSPENSER CARTRIDGE CAT. NO. 523500- K792378 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Dec 1979. https://www.510kdatabase.net/k792384/ 1979-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k792384-principal-analyte-reference-serum-fda-510k.jpg K792384 - PRINCIPAL ANALYTE REFERENCE SERUM K792384 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Dec 1979. https://www.510kdatabase.net/k792186/ 1979-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k792186-howmedica-mix-kit-ii-fda-510k.jpg K792186 - HOWMEDICA MIX-KIT II K792186 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Dec 1979. https://www.510kdatabase.net/k792203/ 1979-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k792203-curved-kuntscher-intramedullary-nail-fda-510k.jpg K792203 - CURVED KUNTSCHER INTRAMEDULLARY NAIL K792203 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Dec 1979. https://www.510kdatabase.net/k792204/ 1979-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k792204-howmedica-compression-staple-system-fda-510k.jpg K792204 - HOWMEDICA COMPRESSION STAPLE SYSTEM K792204 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Dec 1979. https://www.510kdatabase.net/k792240/ 1979-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k792240-polycentric-total-knee-metal-tibial-fda-510k.jpg K792240 - POLYCENTRIC TOTAL KNEE METAL TIBIAL K792240 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Dec 1979. https://www.510kdatabase.net/k792253/ 1979-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k792253-ariculated-tension-device-synthes-ten-fda-510k.jpg K792253 - ARICULATED TENSION DEVICE SYNTHES TEN K792253 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Dec 1979. https://www.510kdatabase.net/k792348/ 1979-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k792348-stanicor-omni-stanmod-333b334a-gamma-fda-510k.jpg K792348 - STANICOR, OMNI-STAN,MOD 333B,334A GAMMA K792348 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Dec 1979. https://www.510kdatabase.net/k792351/ 1979-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k792351-medtronic-mod-3852-steril-ice-electrode-fda-510k.jpg K792351 - MEDTRONIC MOD. 3852 STERIL-ICE ELECTRODE K792351 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Dec 1979. https://www.510kdatabase.net/k792359/ 1979-12-05 monthly 0.5 https://www.510kdatabase.net/og-image/k792359-medtronic-model-9407-teletrace-transmitt-fda-510k.jpg K792359 - MEDTRONIC MODEL 9407 TELETRACE TRANSMITT K792359 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Dec 1979. https://www.510kdatabase.net/k792114/ 1979-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k792114-emit-barbiturate-assay-fda-510k.jpg K792114 - EMIT-BARBITURATE ASSAY K792114 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Dec 1979. https://www.510kdatabase.net/k792134/ 1979-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k792134-bonchek-shiley-vein-distention-system-fda-510k.jpg K792134 - BONCHEK-SHILEY VEIN DISTENTION SYSTEM K792134 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Dec 1979. https://www.510kdatabase.net/k792310/ 1979-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k792310-norm-trol-fda-510k.jpg K792310 - NORM-TROL K792310 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Dec 1979. https://www.510kdatabase.net/k792335/ 1979-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k792335-helena-factor-viii-deficient-sub-plasma-fda-510k.jpg K792335 - HELENA FACTOR VIII DEFICIENT SUB. PLASMA K792335 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Dec 1979. https://www.510kdatabase.net/k792042/ 1979-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k792042-denture-base-resin-fda-510k.jpg K792042 - DENTURE BASE RESIN K792042 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Nov 1979. https://www.510kdatabase.net/k792184/ 1979-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k792184-lab-tek-ana-test-kit-fda-510k.jpg K792184 - LAB-TEK ANA TEST KIT K792184 is a FDA 510(k) cleared immunology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Nov 1979. https://www.510kdatabase.net/k792309/ 1979-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k792309-castroviejo-vascular-needleholder-538425-fda-510k.jpg K792309 - CASTROVIEJO VASCULAR NEEDLEHOLDER 538425 K792309 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Nov 1979. https://www.510kdatabase.net/k791419/ 1979-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k791419-omnicor-programmer-model-222c-fda-510k.jpg K791419 - OMNICOR PROGRAMMER MODEL 222C K791419 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Nov 1979. https://www.510kdatabase.net/k792061/ 1979-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k792061-cordia-rf-fda-510k.jpg K792061 - CORDIA RF K792061 is a FDA 510(k) cleared immunology medical device. Manufacturer: Cordis Corp.. Cleared Nov 1979. https://www.510kdatabase.net/k792188/ 1979-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k792188-tetrabead-125-t4-solid-phase-diag-kit-fda-510k.jpg K792188 - TETRABEAD - 125 T4 SOLID PHASE DIAG. KIT K792188 is a FDA 510(k) cleared immunology medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1979. https://www.510kdatabase.net/k792234/ 1979-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k792234-single-vial-colorimetrictriglycerides-fda-510k.jpg K792234 - SINGLE VIAL COLORIMETRIC/TRIGLYCERIDES K792234 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Nov 1979. https://www.510kdatabase.net/k792265/ 1979-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k792265-shiley-pressure-relief-adapter-pra-fda-510k.jpg K792265 - SHILEY PRESSURE RELIEF ADAPTER PRA K792265 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shiley, Inc.. Cleared Nov 1979. https://www.510kdatabase.net/k792315/ 1979-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k792315-ade-aspen-dispersive-electrode-fda-510k.jpg K792315 - A.D.E. ASPEN DISPERSIVE ELECTRODE K792315 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Zimmer, Inc.. Cleared Nov 1979. https://www.510kdatabase.net/k792206/ 1979-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k792206-medtronic-burr-hole-plug-cap-fda-510k.jpg K792206 - MEDTRONIC BURR HOLE PLUG & CAP K792206 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Nov 1979. https://www.510kdatabase.net/k792229/ 1979-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k792229-electrocardiograph-model-ecg-5151-fda-510k.jpg K792229 - ELECTROCARDIOGRAPH, MODEL ECG-5151 K792229 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Nov 1979. https://www.510kdatabase.net/k792246/ 1979-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k792246-medtronic-model-9408-teletrace-transmit-fda-510k.jpg K792246 - MEDTRONIC MODEL 9408 TELETRACE TRANSMIT K792246 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Nov 1979. https://www.510kdatabase.net/k792311/ 1979-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k792311-medtronic-model-7728-neuromod-fda-510k.jpg K792311 - MEDTRONIC MODEL 7728 NEUROMOD K792311 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Nov 1979. https://www.510kdatabase.net/k791973/ 1979-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k791973-howmedica-a-35-dental-alloy-fda-510k.jpg K791973 - HOWMEDICA A-35 DENTAL ALLOY K791973 is a FDA 510(k) cleared dental medical device. Manufacturer: Howmedica Corp.. Cleared Nov 1979. https://www.510kdatabase.net/k792008/ 1979-11-20 monthly 0.5 https://www.510kdatabase.net/og-image/k792008-howmedica-ag-pd-crown-and-bridge-alloy-fda-510k.jpg K792008 - HOWMEDICA AG-PD CROWN AND BRIDGE ALLOY K792008 is a FDA 510(k) cleared dental medical device. Manufacturer: Howmedica Corp.. Cleared Nov 1979. https://www.510kdatabase.net/k791746/ 1979-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k791746-rotazyme-fda-510k.jpg K791746 - ROTAZYME K791746 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1979. https://www.510kdatabase.net/k791789/ 1979-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k791789-3m-microbial-profile-system-gram-fda-510k.jpg K791789 - 3M MICROBIAL PROFILE SYSTEM GRAM K791789 is a FDA 510(k) cleared microbiology medical device. Manufacturer: 3M Company. Cleared Nov 1979. https://www.510kdatabase.net/k791894/ 1979-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k791894-3m-brand-total-leg-compression-tlc-sys-fda-510k.jpg K791894 - 3M BRAND TOTAL LEG COMPRESSION TLC SYS. K791894 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: 3M Company. Cleared Nov 1979. https://www.510kdatabase.net/k792033/ 1979-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k792033-dynacor-sterile-blood-gas-specimen-tray-fda-510k.jpg K792033 - DYNACOR STERILE BLOOD GAS SPECIMEN TRAY K792033 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Nov 1979. https://www.510kdatabase.net/k792158/ 1979-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k792158-3388-reporting-integrator-fda-510k.jpg K792158 - 3388 REPORTING INTEGRATOR K792158 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Nov 1979. https://www.510kdatabase.net/k791316/ 1979-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k791316-medtronic-models-59845985-fda-510k.jpg K791316 - MEDTRONIC MODELS 5984/5985 K791316 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Nov 1979. https://www.510kdatabase.net/k792181/ 1979-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k792181-3m-hs-22-femoral-component-fda-510k.jpg K792181 - 3M HS 22 FEMORAL COMPONENT K792181 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 3M Company. Cleared Nov 1979. https://www.510kdatabase.net/k791566/ 1979-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k791566-model-as-6c-infusion-pump-fda-510k.jpg K791566 - MODEL AS* 6C INFUSION PUMP K791566 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Nov 1979. https://www.510kdatabase.net/k791747/ 1979-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k791747-htsh-neonate-ria-diagnostic-kit-fda-510k.jpg K791747 - HTSH NEONATE RIA DIAGNOSTIC KIT K791747 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1979. https://www.510kdatabase.net/k791822/ 1979-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k791822-bioguard-infusion-line-filter-fda-510k.jpg K791822 - BIOGUARD INFUSION LINE FILTER K791822 is a FDA 510(k) cleared general hospital medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Nov 1979. https://www.510kdatabase.net/k791873/ 1979-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k791873-usci-safe-t-cloth-thermodilution-cat-fda-510k.jpg K791873 - USCI SAFE-T-CLOTH THERMODILUTION CAT. K791873 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 1979. https://www.510kdatabase.net/k791899/ 1979-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k791899-cycler-sets-mod-5c4143-5c4144-5c4145-fda-510k.jpg K791899 - CYCLER SETS MOD. #5C4143, 5C4144, 5C4145 K791899 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Nov 1979. https://www.510kdatabase.net/k791947/ 1979-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k791947-shiley-cardioplegic-solution-del-sets-fda-510k.jpg K791947 - SHILEY CARDIOPLEGIC SOLUTION DEL SETS K791947 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Nov 1979. https://www.510kdatabase.net/k791963/ 1979-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k791963-usci-mullins-transseptal-catheter-intro-fda-510k.jpg K791963 - USCI MULLINS TRANSSEPTAL CATHETER INTRO. K791963 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 1979. https://www.510kdatabase.net/k791979/ 1979-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k791979-technicon-fast-lc-sys-anticonvu-drugs-fda-510k.jpg K791979 - TECHNICON FAST-LC SYS. ANTICONVU DRUGS K791979 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Nov 1979. https://www.510kdatabase.net/k792040/ 1979-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k792040-bard-biomedical-printed-silver-electrode-fda-510k.jpg K792040 - BARD BIOMEDICAL PRINTED SILVER ELECTRODE K792040 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 1979. https://www.510kdatabase.net/k792129/ 1979-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k792129-emit-clinical-processor-cp-5000-fda-510k.jpg K792129 - EMIT CLINICAL PROCESSOR-CP 5000 K792129 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Nov 1979. https://www.510kdatabase.net/k792139/ 1979-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k792139-feather-lite-urinary-div-pouch-fda-510k.jpg K792139 - FEATHER-LITE URINARY DIV. POUCH K792139 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Howmedica Corp.. Cleared Nov 1979. https://www.510kdatabase.net/k792166/ 1979-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k792166-125-i-prolactin-hormone-ria-kit-fda-510k.jpg K792166 - 125 I PROLACTIN HORMONE RIA KIT K792166 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Nov 1979. https://www.510kdatabase.net/k792167/ 1979-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k792167-125-i-folate-solid-phase-radioassay-fda-510k.jpg K792167 - 125 I FOLATE SOLID PHASE RADIOASSAY K792167 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1979. https://www.510kdatabase.net/k792168/ 1979-11-13 monthly 0.5 https://www.510kdatabase.net/og-image/k792168-lifeline-endocardial-pacing-lead-fda-510k.jpg K792168 - LIFELINE - ENDOCARDIAL PACING LEAD K792168 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Nov 1979. https://www.510kdatabase.net/k791765/ 1979-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k791765-masterson-endometrial-biopsy-kit-fda-510k.jpg K791765 - MASTERSON* ENDOMETRIAL BIOPSY KIT K791765 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Nov 1979. https://www.510kdatabase.net/k791768/ 1979-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k791768-cordis-permanent-pervenous-cardiac-leads-fda-510k.jpg K791768 - CORDIS PERMANENT PERVENOUS CARDIAC LEADS K791768 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Nov 1979. https://www.510kdatabase.net/k791969/ 1979-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k791969-dynacor-sterile-closed-sys-drainage-bag-fda-510k.jpg K791969 - DYNACOR STERILE CLOSED SYS. DRAINAGE BAG K791969 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medline Industries, Inc.. Cleared Nov 1979. https://www.510kdatabase.net/k791971/ 1979-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k791971-monoject-sickle-cell-kit-fda-510k.jpg K791971 - MONOJECT SICKLE CELL KIT K791971 is a FDA 510(k) cleared immunology medical device. Manufacturer: Sherwood Medical Co.. Cleared Nov 1979. https://www.510kdatabase.net/k792031/ 1979-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k792031-lancer-coagent-pt-kit-fda-510k.jpg K792031 - LANCER COAGENT PT KIT K792031 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Sherwood Medical Co.. Cleared Nov 1979. https://www.510kdatabase.net/k792048/ 1979-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k792048-lancer-coagent-aptt-kit-fda-510k.jpg K792048 - LANCER COAGENT APTT KIT K792048 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sherwood Medical Co.. Cleared Nov 1979. https://www.510kdatabase.net/k791521/ 1979-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k791521-veri-vu-lensometer-fda-510k.jpg K791521 - VERI-VU LENSOMETER K791521 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Intermedics, Inc.. Cleared Oct 1979. https://www.510kdatabase.net/k791823/ 1979-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k791823-3m-upf-proximal-femur-replacement-system-fda-510k.jpg K791823 - 3M UPF PROXIMAL FEMUR REPLACEMENT SYSTEM K791823 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 3M Company. Cleared Oct 1979. https://www.510kdatabase.net/k791837/ 1979-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k791837-vma-by-column-test-fda-510k.jpg K791837 - VMA BY COLUMN TEST K791837 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Oct 1979. https://www.510kdatabase.net/k791893/ 1979-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k791893-19091-xxxxx-ser-of-glass-capillary-col-fda-510k.jpg K791893 - 19091-XXXXX SER. OF GLASS CAPILLARY COL. K791893 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Oct 1979. https://www.510kdatabase.net/k791988/ 1979-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k791988-repl-piston-for-troutman-corneal-punch-fda-510k.jpg K791988 - REPL. PISTON FOR TROUTMAN CORNEAL PUNCH K791988 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Edward Weck, Inc.. Cleared Oct 1979. https://www.510kdatabase.net/k792024/ 1979-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k792024-lipotrol-fda-510k.jpg K792024 - LIPOTROL K792024 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Oct 1979. https://www.510kdatabase.net/k792025/ 1979-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k792025-lyophilized-hdl-cholesterol-controls-fda-510k.jpg K792025 - LYOPHILIZED HDL CHOLESTEROL CONTROLS K792025 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Oct 1979. https://www.510kdatabase.net/k792039/ 1979-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k792039-william-harvey-h-1500-blood-oxygenator-fda-510k.jpg K792039 - WILLIAM HARVEY H-1500 BLOOD OXYGENATOR K792039 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 1979. https://www.510kdatabase.net/k791755/ 1979-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k791755-datason-gs-fda-510k.jpg K791755 - DATASON-GS K791755 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Oct 1979. https://www.510kdatabase.net/k791774/ 1979-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k791774-life-care-1000mlemp-cont-wat-y-tran-fda-510k.jpg K791774 - LIFE CARE 1000ML.EMP. CONT. W/AT. Y-TRAN K791774 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1979. https://www.510kdatabase.net/k791830/ 1979-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k791830-lu-arm-neuro-vascular-b5080b-fda-510k.jpg K791830 - L/U ARM - NEURO - VASCULAR #B5080B K791830 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Oct 1979. https://www.510kdatabase.net/k791858/ 1979-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k791858-cardioplegia-admin-sets-fda-510k.jpg K791858 - CARDIOPLEGIA ADMIN. SETS K791858 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Oct 1979. https://www.510kdatabase.net/k791930/ 1979-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k791930-iv-extension-set-sl-fda-510k.jpg K791930 - IV EXTENSION SET SL K791930 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1979. https://www.510kdatabase.net/k791992/ 1979-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k791992-dynacor-sterile-carelon-silicone-cath-fda-510k.jpg K791992 - DYNACOR STERILE CARELON SILICONE CATH. K791992 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medline Industries, Inc.. Cleared Oct 1979. https://www.510kdatabase.net/k792022/ 1979-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k792022-herbert-bone-screw-fda-510k.jpg K792022 - HERBERT BONE SCREW K792022 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Oct 1979. https://www.510kdatabase.net/k792088/ 1979-10-26 monthly 0.5 https://www.510kdatabase.net/og-image/k792088-aortic-occluder-000390-fda-510k.jpg K792088 - AORTIC OCCLUDER #000390 K792088 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edward Weck, Inc.. Cleared Oct 1979. https://www.510kdatabase.net/k791088/ 1979-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k791088-monoject-pulp-capping-material-fda-510k.jpg K791088 - MONOJECT PULP-CAPPING MATERIAL K791088 is a FDA 510(k) cleared dental medical device. Manufacturer: Sherwood Medical Co.. Cleared Oct 1979. https://www.510kdatabase.net/k791783/ 1979-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k791783-omni-stanicor-theta-mod-237a-fda-510k.jpg K791783 - OMNI-STANICOR (THETA) MOD 237A K791783 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Oct 1979. https://www.510kdatabase.net/k791788/ 1979-10-22 monthly 0.5 https://www.510kdatabase.net/og-image/k791788-micro-ring-system-precision-attach-fda-510k.jpg K791788 - MICRO-RING SYSTEM PRECISION ATTACH. K791788 is a FDA 510(k) cleared dental medical device. Manufacturer: Howmedica Corp.. Cleared Oct 1979. https://www.510kdatabase.net/k791326/ 1979-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k791326-monoject-endosseous-dental-implant-tool-fda-510k.jpg K791326 - MONOJECT ENDOSSEOUS DENTAL IMPLANT TOOL K791326 is a FDA 510(k) cleared dental medical device. Manufacturer: Sherwood Medical Co.. Cleared Oct 1979. https://www.510kdatabase.net/k791401/ 1979-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k791401-lancer-l-ina-anti-iga-fda-510k.jpg K791401 - LANCER L-INA ANTI-IGA K791401 is a FDA 510(k) cleared immunology medical device. Manufacturer: Sherwood Medical Co.. Cleared Oct 1979. https://www.510kdatabase.net/k791402/ 1979-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k791402-lancer-l-ina-anti-igm-fda-510k.jpg K791402 - LANCER L-INA ANTI-IGM K791402 is a FDA 510(k) cleared immunology medical device. Manufacturer: Sherwood Medical Co.. Cleared Oct 1979. https://www.510kdatabase.net/k791403/ 1979-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k791403-lancer-l-ina-anti-igg-fda-510k.jpg K791403 - LANCER L-INA ANTI-IGG K791403 is a FDA 510(k) cleared immunology medical device. Manufacturer: Sherwood Medical Co.. Cleared Oct 1979. https://www.510kdatabase.net/k791404/ 1979-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k791404-lancer-l-ina-anti-c3-fda-510k.jpg K791404 - LANCER L-INA ANTI-C3 K791404 is a FDA 510(k) cleared immunology medical device. Manufacturer: Sherwood Medical Co.. Cleared Oct 1979. https://www.510kdatabase.net/k791596/ 1979-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k791596-fluoromatic-tobramycin-fia-immunoassay-fda-510k.jpg K791596 - FLUOROMATIC TOBRAMYCIN FIA IMMUNOASSAY K791596 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bio-Rad. Cleared Oct 1979. https://www.510kdatabase.net/k791642/ 1979-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k791642-a-gent-glycospec-fda-510k.jpg K791642 - A-GENT GLYCOSPEC K791642 is a FDA 510(k) cleared hematology medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1979. https://www.510kdatabase.net/k791770/ 1979-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k791770-quantimune-gentamicin-ria-gentamicin-fda-510k.jpg K791770 - QUANTIMUNE GENTAMICIN RIA GENTAMICIN K791770 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bio-Rad. Cleared Oct 1979. https://www.510kdatabase.net/k791845/ 1979-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k791845-bayonet-heifetz-clip-appliers-fda-510k.jpg K791845 - BAYONET HEIFETZ CLIP APPLIERS K791845 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Oct 1979. https://www.510kdatabase.net/k791984/ 1979-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k791984-scissors-s-229422622263-fda-510k.jpg K791984 - SCISSOR'S #'S 2294,2262,2263 K791984 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Oct 1979. https://www.510kdatabase.net/k791989/ 1979-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k791989-technicon-c202-system-fda-510k.jpg K791989 - TECHNICON C202 SYSTEM K791989 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Oct 1979. https://www.510kdatabase.net/k791990/ 1979-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k791990-technicon-hdl-cholesterol-method-fda-510k.jpg K791990 - TECHNICON HDL CHOLESTEROL METHOD K791990 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Oct 1979. https://www.510kdatabase.net/k791547/ 1979-10-12 monthly 0.5 https://www.510kdatabase.net/og-image/k791547-fluoromatic-gentamicin-fia-immunoassay-fda-510k.jpg K791547 - FLUOROMATIC GENTAMICIN FIA IMMUNOASSAY K791547 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bio-Rad. Cleared Oct 1979. https://www.510kdatabase.net/k791431/ 1979-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k791431-technicon-fast-lc-sys-for-theophylline-fda-510k.jpg K791431 - TECHNICON FAST-LC SYS. FOR THEOPHYLLINE K791431 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Oct 1979. https://www.510kdatabase.net/k791914/ 1979-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k791914-3-way-stopcock-wmale-locking-luer-ada-fda-510k.jpg K791914 - 3-WAY STOPCOCK W/MALE LOCKING LUER ADA. K791914 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1979. https://www.510kdatabase.net/k791964/ 1979-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k791964-model-15055a-mainframe-fda-510k.jpg K791964 - MODEL 15055A MAINFRAME K791964 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Oct 1979. https://www.510kdatabase.net/k791972/ 1979-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k791972-argyle-pediatric-vena-caval-catheter-fda-510k.jpg K791972 - ARGYLE PEDIATRIC VENA CAVAL CATHETER K791972 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Sherwood Medical Co.. Cleared Oct 1979. https://www.510kdatabase.net/k791304/ 1979-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k791304-howmedica-a-30-dental-alloy-fda-510k.jpg K791304 - HOWMEDICA A-30 DENTAL ALLOY K791304 is a FDA 510(k) cleared dental medical device. Manufacturer: Howmedica Corp.. Cleared Oct 1979. https://www.510kdatabase.net/k791703/ 1979-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k791703-tew-bypass-instruments-dissecting-kit-fda-510k.jpg K791703 - TEW BYPASS INSTRUMENTS & DISSECTING KIT K791703 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Oct 1979. https://www.510kdatabase.net/k791741/ 1979-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k791741-floor-line-instruments-fda-510k.jpg K791741 - FLOOR LINE INSTRUMENTS K791741 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Oct 1979. https://www.510kdatabase.net/k791742/ 1979-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k791742-brooks-gall-bladder-scissors-surg-fda-510k.jpg K791742 - BROOKS GALL BLADDER SCISSORS (SURG) K791742 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Oct 1979. https://www.510kdatabase.net/k791759/ 1979-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k791759-test-pressure-gauge-6675-32-fda-510k.jpg K791759 - TEST PRESSURE GAUGE #6675-32 K791759 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Depuy, Inc.. Cleared Oct 1979. https://www.510kdatabase.net/k791960/ 1979-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k791960-roth-kennedy-passer-fda-510k.jpg K791960 - ROTH-KENNEDY PASSER K791960 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 3M Company. Cleared Oct 1979. https://www.510kdatabase.net/k791980/ 1979-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k791980-tomes-s-122112221223131466406642-fda-510k.jpg K791980 - TOME'S #'S 1221,1222,1223,1314,6640,6642 K791980 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Edward Weck, Inc.. Cleared Oct 1979. https://www.510kdatabase.net/k791981/ 1979-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k791981-swan-knife-needle-15mm-cat-1170-fda-510k.jpg K791981 - SWAN KNIFE NEEDLE 1.5MM CAT # 1170 K791981 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Edward Weck, Inc.. Cleared Oct 1979. https://www.510kdatabase.net/k791982/ 1979-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k791982-cannulas-cat-s-6636-6624-6625-fda-510k.jpg K791982 - CANNULA'S CAT #'S 6636, 6624, 6625 K791982 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Edward Weck, Inc.. Cleared Oct 1979. https://www.510kdatabase.net/k791983/ 1979-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k791983-spatulas-s-76187248724072425108-fda-510k.jpg K791983 - SPATULA'S #'S 7618,7248,7240,7242,5108 K791983 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Edward Weck, Inc.. Cleared Oct 1979. https://www.510kdatabase.net/k791985/ 1979-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k791985-hooks-s-7600760276037616-fda-510k.jpg K791985 - HOOKS #'S 7600,7602,7603,7616 K791985 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Edward Weck, Inc.. Cleared Oct 1979. https://www.510kdatabase.net/k791986/ 1979-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k791986-fix-lens-for-s-3510351232483795-fda-510k.jpg K791986 - FIX. & LENS FOR. #'S 3510,3512,3248,3795 K791986 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Edward Weck, Inc.. Cleared Oct 1979. https://www.510kdatabase.net/k791987/ 1979-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k791987-vascular-forceps-clamps-fda-510k.jpg K791987 - VASCULAR FORCEPS & CLAMPS K791987 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Oct 1979. https://www.510kdatabase.net/k791581/ 1979-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k791581-coloplast-carbon-gas-filter-fda-510k.jpg K791581 - COLOPLAST CARBON GAS FILTER K791581 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 1979. https://www.510kdatabase.net/k791778/ 1979-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k791778-medtronic-model-9410-teletrace-receiver-fda-510k.jpg K791778 - MEDTRONIC MODEL 9410 TELETRACE RECEIVER K791778 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Oct 1979. https://www.510kdatabase.net/k791829/ 1979-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k791829-shiley-quick-disconnect-assembly-fda-510k.jpg K791829 - SHILEY QUICK DISCONNECT ASSEMBLY K791829 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Oct 1979. https://www.510kdatabase.net/k790775/ 1979-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k790775-intra-aortic-balloon-type-s-fda-510k.jpg K790775 - INTRA-AORTIC BALLOON, TYPE S K790775 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Oct 1979. https://www.510kdatabase.net/k791764/ 1979-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k791764-scoville-lewis-aneurysm-clips-fda-510k.jpg K791764 - SCOVILLE-LEWIS ANEURYSM CLIPS K791764 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Oct 1979. https://www.510kdatabase.net/k791794/ 1979-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k791794-factor-vii-deficient-plasma-fda-510k.jpg K791794 - FACTOR VII DEFICIENT PLASMA K791794 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Chemical Co.. Cleared Oct 1979. https://www.510kdatabase.net/k791796/ 1979-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k791796-additive-hinge-cap-fda-510k.jpg K791796 - ADDITIVE HINGE CAP K791796 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1979. https://www.510kdatabase.net/k791836/ 1979-10-01 monthly 0.5 https://www.510kdatabase.net/og-image/k791836-quantimune-hfsh-ria-fda-510k.jpg K791836 - QUANTIMUNE HFSH RIA K791836 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Oct 1979. https://www.510kdatabase.net/k790068/ 1979-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k790068-pulse-generators-models-5983-5989-fda-510k.jpg K790068 - PULSE GENERATORS, MODELS 5983, 5989 K790068 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Sep 1979. https://www.510kdatabase.net/k791204/ 1979-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k791204-miter-endosteal-blade-implant-fda-510k.jpg K791204 - MITER ENDOSTEAL BLADE IMPLANT K791204 is a FDA 510(k) cleared dental medical device. Manufacturer: Depuy, Inc.. Cleared Sep 1979. https://www.510kdatabase.net/k791784/ 1979-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k791784-cordis-bipolar-pacer-connector-system-fda-510k.jpg K791784 - CORDIS BIPOLAR PACER CONNECTOR SYSTEM K791784 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Sep 1979. https://www.510kdatabase.net/k791978/ 1979-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k791978-sugita-aneurysm-clips-appliers-case-fda-510k.jpg K791978 - SUGITA ANEURYSM CLIPS, APPLIERS & CASE K791978 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Sep 1979. https://www.510kdatabase.net/k791549/ 1979-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k791549-technicon-star-system-fda-510k.jpg K791549 - TECHNICON STAR SYSTEM K791549 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Sep 1979. https://www.510kdatabase.net/k791828/ 1979-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k791828-bjork-shiley-pulmonic-graft-valve-fda-510k.jpg K791828 - BJORK-SHILEY PULMONIC GRAFT VALVE K791828 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Sep 1979. https://www.510kdatabase.net/k791743/ 1979-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k791743-weck-rack-sterilizing-accessory-tray-fda-510k.jpg K791743 - WECK RACK (STERILIZING ACCESSORY TRAY) K791743 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Sep 1979. https://www.510kdatabase.net/k791181/ 1979-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k791181-programmer-medtronic-model-59845985-fda-510k.jpg K791181 - PROGRAMMER, MEDTRONIC MODEL 5984/5985 K791181 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Sep 1979. https://www.510kdatabase.net/k790143/ 1979-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k790143-ventricular-lead-model-6959-fda-510k.jpg K790143 - VENTRICULAR LEAD, MODEL 6959 K790143 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Sep 1979. https://www.510kdatabase.net/k791442/ 1979-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k791442-bard-biomedical-nerve-locator-fda-510k.jpg K791442 - BARD BIOMEDICAL NERVE LOCATOR K791442 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Sep 1979. https://www.510kdatabase.net/k791568/ 1979-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k791568-implantable-pulse-generator-pacemakers-fda-510k.jpg K791568 - IMPLANTABLE PULSE GENERATOR PACEMAKERS K791568 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Sep 1979. https://www.510kdatabase.net/k791769/ 1979-09-19 monthly 0.5 https://www.510kdatabase.net/og-image/k791769-medtronic-model-6957-fda-510k.jpg K791769 - MEDTRONIC MODEL 6957 K791769 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Sep 1979. https://www.510kdatabase.net/k791149/ 1979-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k791149-stimulator-model-sss-1101-fda-510k.jpg K791149 - STIMULATOR MODEL SSS-1101 K791149 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Sep 1979. https://www.510kdatabase.net/k791343/ 1979-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k791343-model-1338a-crt-display-fda-510k.jpg K791343 - MODEL 1338A CRT DISPLAY K791343 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Sep 1979. https://www.510kdatabase.net/k791344/ 1979-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k791344-model-1350-graphics-translator-fda-510k.jpg K791344 - MODEL 1350 GRAPHICS TRANSLATOR K791344 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Sep 1979. https://www.510kdatabase.net/k791405/ 1979-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k791405-125i-leutinizing-hormone-ria-kit-fda-510k.jpg K791405 - 125I LEUTINIZING HORMONE RIA KIT K791405 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Diagnostic Products Corp.. Cleared Sep 1979. https://www.510kdatabase.net/k791650/ 1979-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k791650-human-c-reactive-protein-crp-fda-510k.jpg K791650 - HUMAN, C-REACTIVE PROTEIN (CRP) K791650 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Sep 1979. https://www.510kdatabase.net/k791683/ 1979-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k791683-sterile-water-for-respiratory-therapy-fda-510k.jpg K791683 - STERILE WATER FOR RESPIRATORY THERAPY K791683 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1979. https://www.510kdatabase.net/k791717/ 1979-09-17 monthly 0.5 https://www.510kdatabase.net/og-image/k791717-bard-urodynamic-catheters-fda-510k.jpg K791717 - BARD URODYNAMIC CATHETERS K791717 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Sep 1979. https://www.510kdatabase.net/k791150/ 1979-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k791150-electroencephalographs-models-72097213-fda-510k.jpg K791150 - ELECTROENCEPHALOGRAPHS MODELS 7209,7213 K791150 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Sep 1979. https://www.510kdatabase.net/k791233/ 1979-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k791233-model-eeg-4214-electroencephalograph-fda-510k.jpg K791233 - MODEL EEG-4214 ELECTROENCEPHALOGRAPH K791233 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Sep 1979. https://www.510kdatabase.net/k791234/ 1979-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k791234-model-eeg-4217-electroencephalograph-fda-510k.jpg K791234 - MODEL EEG-4217 ELECTROENCEPHALOGRAPH K791234 is a FDA 510(k) cleared neurology medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Sep 1979. https://www.510kdatabase.net/k791318/ 1979-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k791318-miradapt-dental-restorative-fda-510k.jpg K791318 - MIRADAPT* DENTAL RESTORATIVE K791318 is a FDA 510(k) cleared dental medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Sep 1979. https://www.510kdatabase.net/k791319/ 1979-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k791319-miradapt-polishing-instruments-fda-510k.jpg K791319 - MIRADAPT* POLISHING INSTRUMENTS K791319 is a FDA 510(k) cleared dental medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Sep 1979. https://www.510kdatabase.net/k791377/ 1979-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k791377-model-484-01-bipolar-coaxial-pacing-lead-fda-510k.jpg K791377 - MODEL 484-01 BIPOLAR COAXIAL PACING LEAD K791377 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Sep 1979. https://www.510kdatabase.net/k791378/ 1979-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k791378-model-482-01-bipolar-coaxial-pacing-lead-fda-510k.jpg K791378 - MODEL 482-01 BIPOLAR COAXIAL PACING LEAD K791378 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Sep 1979. https://www.510kdatabase.net/k791379/ 1979-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k791379-model-228-02-thinlith-ii-pacemaker-bipo-fda-510k.jpg K791379 - MODEL 228-02 THINLITH II PACEMAKER, BIPO K791379 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Sep 1979. https://www.510kdatabase.net/k791528/ 1979-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k791528-flexifo-enteral-nutrition-pump-fda-510k.jpg K791528 - FLEXIFO ENTERAL NUTRITION PUMP K791528 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1979. https://www.510kdatabase.net/k791531/ 1979-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k791531-flexiflo-enteral-pump-set-fda-510k.jpg K791531 - FLEXIFLO ENTERAL PUMP SET K791531 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1979. https://www.510kdatabase.net/k791710/ 1979-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k791710-cardiovascular-instruments-various-fda-510k.jpg K791710 - CARDIOVASCULAR INSTRUMENTS-VARIOUS K791710 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edward Weck, Inc.. Cleared Sep 1979. https://www.510kdatabase.net/k791734/ 1979-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k791734-surgical-instruments-heifetz-digitate-fda-510k.jpg K791734 - SURGICAL INSTRUMENTS HEIFETZ DIGITATE K791734 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Sep 1979. https://www.510kdatabase.net/k791667/ 1979-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k791667-medtronic-models-69914699ou-fda-510k.jpg K791667 - MEDTRONIC MODELS 69914/699OU K791667 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Sep 1979. https://www.510kdatabase.net/k791360/ 1979-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k791360-kodak-ortho-m-film-fda-510k.jpg K791360 - KODAK ORTHO M FILM K791360 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Sep 1979. https://www.510kdatabase.net/k791362/ 1979-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k791362-electrosurgical-cut-and-coagu-accessory-fda-510k.jpg K791362 - ELECTROSURGICAL CUT AND COAGU ACCESSORY K791362 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intermedics, Inc.. Cleared Sep 1979. https://www.510kdatabase.net/k791417/ 1979-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k791417-implantable-pulse-generator-pacemaker-fda-510k.jpg K791417 - IMPLANTABLE PULSE GENERATOR PACEMAKER K791417 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Sep 1979. https://www.510kdatabase.net/k791502/ 1979-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k791502-quantimune-tobramycin-ria-radioimmuno-fda-510k.jpg K791502 - QUANTIMUNE TOBRAMYCIN RIA RADIOIMMUNO K791502 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bio-Rad. Cleared Sep 1979. https://www.510kdatabase.net/k791540/ 1979-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k791540-electrocardiograph-model-ecg-5403-fda-510k.jpg K791540 - ELECTROCARDIOGRAPH MODEL ECG-5403 K791540 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Nihon Kohden America, Inc.. Cleared Sep 1979. https://www.510kdatabase.net/k791570/ 1979-09-04 monthly 0.5 https://www.510kdatabase.net/og-image/k791570-il-model-end-tidal-co2-analyzer-fda-510k.jpg K791570 - IL MODEL END TIDAL CO2 ANALYZER K791570 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 1979. https://www.510kdatabase.net/k782049/ 1979-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k782049-bioassay-system-ms-2-serum-fda-510k.jpg K782049 - BIOASSAY SYSTEM, MS-2 SERUM K782049 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1979. https://www.510kdatabase.net/k791101/ 1979-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k791101-disposable-perforators-jacobs-hudson-fda-510k.jpg K791101 - DISPOSABLE PERFORATORS, JACOBS, HUDSON K791101 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Aug 1979. https://www.510kdatabase.net/k791430/ 1979-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k791430-miniprime-hypothermic-heat-exchanger-fda-510k.jpg K791430 - MINIPRIME HYPOTHERMIC HEAT EXCHANGER K791430 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Aug 1979. https://www.510kdatabase.net/k791487/ 1979-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k791487-model-78520a-arrhythmia-monitoring-sys-fda-510k.jpg K791487 - MODEL 78520A ARRHYTHMIA MONITORING SYS K791487 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Aug 1979. https://www.510kdatabase.net/k791619/ 1979-08-28 monthly 0.5 https://www.510kdatabase.net/og-image/k791619-dynamic-hip-screw-fda-510k.jpg K791619 - DYNAMIC HIP SCREW K791619 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Synthes (Usa). Cleared Aug 1979. https://www.510kdatabase.net/k791327/ 1979-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k791327-argyle-taussig-culture-catheter-fda-510k.jpg K791327 - ARGYLE TAUSSIG CULTURE CATHETER K791327 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Sherwood Medical Co.. Cleared Aug 1979. https://www.510kdatabase.net/k791428/ 1979-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k791428-glucohemoglobin-control-fda-510k.jpg K791428 - GLUCOHEMOGLOBIN CONTROL K791428 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1979. https://www.510kdatabase.net/k790976/ 1979-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k790976-rubazyme-fda-510k.jpg K790976 - RUBAZYME K790976 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1979. https://www.510kdatabase.net/k791315/ 1979-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k791315-spectro-sur-set-fda-510k.jpg K791315 - SPECTRO-SUR SET K791315 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Aug 1979. https://www.510kdatabase.net/k791339/ 1979-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k791339-human-ceruloplasmin-fda-510k.jpg K791339 - HUMAN CERULOPLASMIN K791339 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Aug 1979. https://www.510kdatabase.net/k791340/ 1979-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k791340-human-alpha2-macroglobulin-fda-510k.jpg K791340 - HUMAN ALPHA2 MACROGLOBULIN K791340 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Aug 1979. https://www.510kdatabase.net/k791341/ 1979-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k791341-human-alpha-acid-glycoprotein-fda-510k.jpg K791341 - HUMAN ALPHA, ACID GLYCOPROTEIN K791341 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Aug 1979. https://www.510kdatabase.net/k791435/ 1979-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k791435-ames-tdatobramycin-fda-510k.jpg K791435 - AMES TDA/TOBRAMYCIN K791435 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Aug 1979. https://www.510kdatabase.net/k790848/ 1979-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k790848-a-gent-quantichrom-t4-11a-fda-510k.jpg K790848 - A-GENT QUANTICHROM T4 11A K790848 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1979. https://www.510kdatabase.net/k790960/ 1979-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k790960-quantimune-t-3-fia-fda-510k.jpg K790960 - QUANTIMUNE T-3 FIA K790960 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Aug 1979. https://www.510kdatabase.net/k791106/ 1979-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k791106-sterile-disposable-centrifuge-bowl-fda-510k.jpg K791106 - STERILE, DISPOSABLE CENTRIFUGE BOWL K791106 is a FDA 510(k) cleared hematology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Aug 1979. https://www.510kdatabase.net/k791141/ 1979-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k791141-bilirubin-calibrator-control-fda-510k.jpg K791141 - BILIRUBIN CALIBRATOR CONTROL K791141 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Aug 1979. https://www.510kdatabase.net/k791225/ 1979-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k791225-bjork-shiley-aortic-graft-valve-prosth-fda-510k.jpg K791225 - BJORK-SHILEY AORTIC GRAFT VALVE PROSTH K791225 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Aug 1979. https://www.510kdatabase.net/k790774/ 1979-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k790774-loda-wrist-prosthesis-fda-510k.jpg K790774 - LODA WRIST PROSTHESIS K790774 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Aug 1979. https://www.510kdatabase.net/k790920/ 1979-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k790920-intracranial-pressure-monitoring-fda-510k.jpg K790920 - INTRACRANIAL PRESSURE MONITORING K790920 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Aug 1979. https://www.510kdatabase.net/k790935/ 1979-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k790935-delton-pit-and-fissure-sealent-fda-510k.jpg K790935 - DELTON* PIT AND FISSURE SEALENT K790935 is a FDA 510(k) cleared dental medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Aug 1979. https://www.510kdatabase.net/k791144/ 1979-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k791144-bufferizer-fda-510k.jpg K791144 - BUFFERIZER K791144 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Aug 1979. https://www.510kdatabase.net/k791290/ 1979-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k791290-beckman-b-4-teb-buffer-kit-fda-510k.jpg K791290 - BECKMAN B-4 TEB BUFFER KIT K791290 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Aug 1979. https://www.510kdatabase.net/k791351/ 1979-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k791351-cement-spacers-fda-510k.jpg K791351 - CEMENT SPACERS K791351 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Depuy, Inc.. Cleared Aug 1979. https://www.510kdatabase.net/k791364/ 1979-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k791364-quinton-model-630-and-636-ecg-data-cart-fda-510k.jpg K791364 - QUINTON MODEL 630 AND 636 ECG DATA CART K791364 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Aug 1979. https://www.510kdatabase.net/k790321/ 1979-08-01 monthly 0.5 https://www.510kdatabase.net/og-image/k790321-datason-db-fda-510k.jpg K790321 - DATASON DB K790321 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Aug 1979. https://www.510kdatabase.net/k790220/ 1979-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k790220-pacemaker-programmer-fda-510k.jpg K790220 - PACEMAKER PROGRAMMER K790220 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Jul 1979. https://www.510kdatabase.net/k790576/ 1979-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k790576-quantimune-t-4-fia-fda-510k.jpg K790576 - QUANTIMUNE T-4 FIA K790576 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Jul 1979. https://www.510kdatabase.net/k790811/ 1979-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k790811-exeter-bone-lauage-system-fda-510k.jpg K790811 - EXETER BONE LAUAGE SYSTEM K790811 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Howmedica Corp.. Cleared Jul 1979. https://www.510kdatabase.net/k790875/ 1979-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k790875-monoject-endometrial-sampling-kit-fda-510k.jpg K790875 - MONOJECT ENDOMETRIAL SAMPLING KIT K790875 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Sherwood Medical Co.. Cleared Jul 1979. https://www.510kdatabase.net/k791056/ 1979-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k791056-3m-cement-remover-fda-510k.jpg K791056 - 3M CEMENT REMOVER K791056 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 3M Company. Cleared Jul 1979. https://www.510kdatabase.net/k791176/ 1979-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k791176-3m-coldhot-water-bag-and-wrap-fda-510k.jpg K791176 - 3M COLD/HOT WATER BAG AND WRAP K791176 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Jul 1979. https://www.510kdatabase.net/k791218/ 1979-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k791218-inhalation-operated-nebulizer-code-fda-510k.jpg K791218 - INHALATION OPERATED NEBULIZER CODE K791218 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Jul 1979. https://www.510kdatabase.net/k791305/ 1979-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k791305-feltloc-cast-padding-fda-510k.jpg K791305 - FELTLOC CAST PADDING K791305 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Howmedica Corp.. Cleared Jul 1979. https://www.510kdatabase.net/k791329/ 1979-07-30 monthly 0.5 https://www.510kdatabase.net/og-image/k791329-fluoromatic-analyzer-and-autosampler-fda-510k.jpg K791329 - FLUOROMATIC ANALYZER AND AUTOSAMPLER K791329 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Jul 1979. https://www.510kdatabase.net/k791077/ 1979-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k791077-beckman-electrophoresis-ovenincubator-fda-510k.jpg K791077 - BECKMAN ELECTROPHORESIS OVEN/INCUBATOR K791077 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jul 1979. https://www.510kdatabase.net/k791094/ 1979-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k791094-3m-orthopedic-casting-tape-fda-510k.jpg K791094 - 3M ORTHOPEDIC CASTING TAPE K791094 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: 3M Company. Cleared Jul 1979. https://www.510kdatabase.net/k791138/ 1979-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k791138-5880-series-of-gas-chromatographs-fda-510k.jpg K791138 - 5880 SERIES OF GAS CHROMATOGRAPHS K791138 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Jul 1979. https://www.510kdatabase.net/k791276/ 1979-07-24 monthly 0.5 https://www.510kdatabase.net/og-image/k791276-pervenous-lead-introducer-system-fda-510k.jpg K791276 - PERVENOUS LEAD INTRODUCER SYSTEM K791276 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Jul 1979. https://www.510kdatabase.net/k791029/ 1979-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k791029-normal-protein-electrophoresis-control-fda-510k.jpg K791029 - NORMAL PROTEIN ELECTROPHORESIS CONTROL K791029 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jul 1979. https://www.510kdatabase.net/k791031/ 1979-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k791031-abnormal-protein-electrophoresis-control-fda-510k.jpg K791031 - ABNORMAL PROTEIN ELECTROPHORESIS CONTROL K791031 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jul 1979. https://www.510kdatabase.net/k791183/ 1979-07-12 monthly 0.5 https://www.510kdatabase.net/og-image/k791183-swan-ganz-flow-directed-catheter-fda-510k.jpg K791183 - SWAN-GANZ FLOW-DIRECTED CATHETER K791183 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edwards Lifesciences, LLC. Cleared Jul 1979. https://www.510kdatabase.net/k791054/ 1979-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k791054-hyper-chec-sphygmomanometer-electronic-fda-510k.jpg K791054 - HYPER CHEC, SPHYGMOMANOMETER ELECTRONIC K791054 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jul 1979. https://www.510kdatabase.net/k791089/ 1979-07-10 monthly 0.5 https://www.510kdatabase.net/og-image/k791089-sherwood-nebulizer-kit-fda-510k.jpg K791089 - SHERWOOD NEBULIZER KIT K791089 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sherwood Medical Co.. Cleared Jul 1979. https://www.510kdatabase.net/k790429/ 1979-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k790429-medtronic-model-6957-fda-510k.jpg K790429 - MEDTRONIC MODEL 6957 K790429 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jul 1979. https://www.510kdatabase.net/k790865/ 1979-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k790865-lancer-hdl-separation-kit-fda-510k.jpg K790865 - LANCER HDL SEPARATION KIT K790865 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sherwood Medical Co.. Cleared Jun 1979. https://www.510kdatabase.net/k790965/ 1979-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k790965-reagent-strips-for-urinalysis-fda-510k.jpg K790965 - REAGENT STRIPS FOR URINALYSIS K790965 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Jun 1979. https://www.510kdatabase.net/k791135/ 1979-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k791135-lyophilized-g-hb-quik-column-control-fda-510k.jpg K791135 - LYOPHILIZED G-HB QUIK COLUMN CONTROL K791135 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Jun 1979. https://www.510kdatabase.net/k790942/ 1979-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k790942-radview-imager-system-fda-510k.jpg K790942 - RADVIEW IMAGER SYSTEM K790942 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jun 1979. https://www.510kdatabase.net/k790969/ 1979-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k790969-argyle-urine-meter-fda-510k.jpg K790969 - ARGYLE URINE METER K790969 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Sherwood Medical Co.. Cleared Jun 1979. https://www.510kdatabase.net/k790982/ 1979-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k790982-inspiron-nebulo-tm-28-nebulizer-kit-fda-510k.jpg K790982 - INSPIRON NEBULO TM 28 NEBULIZER KIT K790982 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jun 1979. https://www.510kdatabase.net/k790996/ 1979-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k790996-ccf-femoral-debridement-probe-fda-510k.jpg K790996 - C.C.F. FEMORAL DEBRIDEMENT PROBE K790996 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jun 1979. https://www.510kdatabase.net/k791157/ 1979-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k791157-360-hemoclip-appliers-fda-510k.jpg K791157 - 360 HEMOCLIP APPLIERS K791157 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Jun 1979. https://www.510kdatabase.net/k790793/ 1979-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k790793-amc-r-metacarpal-component-fda-510k.jpg K790793 - AMC R METACARPAL COMPONENT K790793 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jun 1979. https://www.510kdatabase.net/k790987/ 1979-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k790987-zimmer-r-total-shoulder-ii-fda-510k.jpg K790987 - ZIMMER R TOTAL SHOULDER II K790987 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Jun 1979. https://www.510kdatabase.net/k791030/ 1979-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k791030-hemoglobin-afsc-electrophoresis-control-fda-510k.jpg K791030 - HEMOGLOBIN AF/SC ELECTROPHORESIS CONTROL K791030 is a FDA 510(k) cleared hematology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jun 1979. https://www.510kdatabase.net/k791057/ 1979-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k791057-cast-brace-components-fda-510k.jpg K791057 - CAST BRACE COMPONENTS K791057 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: 3M Company. Cleared Jun 1979. https://www.510kdatabase.net/k791070/ 1979-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k791070-accu-sorb-sterile-stockinettes-fda-510k.jpg K791070 - ACCU-SORB STERILE STOCKINETTES K791070 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Jun 1979. https://www.510kdatabase.net/k791093/ 1979-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k791093-models-24112418-ventricular-inhibited-fda-510k.jpg K791093 - MODELS 2411/2418 VENTRICULAR-INHIBITED K791093 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jun 1979. https://www.510kdatabase.net/k772011/ 1979-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k772011-wholey-occlusion-balloon-catheter-fda-510k.jpg K772011 - WHOLEY OCCLUSION BALLOON CATHETER K772011 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cook, Inc.. Cleared Jun 1979. https://www.510kdatabase.net/k790398/ 1979-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k790398-emit-dau-phencyclidine-urine-low-fda-510k.jpg K790398 - EMIT-D.A.U. PHENCYCLIDINE URINE LOW K790398 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jun 1979. https://www.510kdatabase.net/k790399/ 1979-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k790399-urine-medium-calibrator-fda-510k.jpg K790399 - URINE MEDIUM CALIBRATOR K790399 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jun 1979. https://www.510kdatabase.net/k790400/ 1979-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k790400-urine-negative-calibrator-fda-510k.jpg K790400 - URINE NEGATIVE CALIBRATOR K790400 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jun 1979. https://www.510kdatabase.net/k790401/ 1979-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k790401-phencyclidine-urine-assay-fda-510k.jpg K790401 - PHENCYCLIDINE URINE ASSAY K790401 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jun 1979. https://www.510kdatabase.net/k790553/ 1979-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k790553-cholesterol-kit-hdl-ds-fda-510k.jpg K790553 - CHOLESTEROL KIT, HDL-DS K790553 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jun 1979. https://www.510kdatabase.net/k790584/ 1979-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k790584-ames-tdagentgmicin-fda-510k.jpg K790584 - AMES TDA/GENTGMICIN K790584 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Jun 1979. https://www.510kdatabase.net/k790772/ 1979-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k790772-chemtab-fda-510k.jpg K790772 - CHEMTAB K790772 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jun 1979. https://www.510kdatabase.net/k790905/ 1979-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k790905-nuclear-sample-reader-fda-510k.jpg K790905 - NUCLEAR SAMPLE READER K790905 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1979. https://www.510kdatabase.net/k790937/ 1979-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k790937-emit-auto-digoxin-assay-fda-510k.jpg K790937 - EMIT AUTO DIGOXIN ASSAY K790937 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jun 1979. https://www.510kdatabase.net/k791060/ 1979-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k791060-rain-x-fda-510k.jpg K791060 - RAIN-X K791060 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Sherwood Medical Co.. Cleared Jun 1979. https://www.510kdatabase.net/k790938/ 1979-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k790938-saphenous-vein-irrigation-pressurizatio-fda-510k.jpg K790938 - SAPHENOUS VEIN IRRIGATION, PRESSURIZATIO K790938 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Jun 1979. https://www.510kdatabase.net/k791047/ 1979-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k791047-nerve-stimulator-digital-peripheral-fda-510k.jpg K791047 - NERVE STIMULATOR, DIGITAL PERIPHERAL K791047 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jun 1979. https://www.510kdatabase.net/k790838/ 1979-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k790838-arterial-embolectomy-catheter-modified-fda-510k.jpg K790838 - ARTERIAL EMBOLECTOMY CATHETER (MODIFIED) K790838 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Jun 1979. https://www.510kdatabase.net/k790939/ 1979-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k790939-model-78501a-patient-monitoring-system-fda-510k.jpg K790939 - MODEL 78501A PATIENT MONITORING SYSTEM K790939 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Jun 1979. https://www.510kdatabase.net/k790988/ 1979-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k790988-model-6971-w-dbs-wire-fda-510k.jpg K790988 - MODEL 6971 W/ DBS WIRE K790988 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jun 1979. https://www.510kdatabase.net/k791009/ 1979-06-11 monthly 0.5 https://www.510kdatabase.net/og-image/k791009-santa-casa-distractor-fda-510k.jpg K791009 - SANTA CASA DISTRACTOR K791009 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jun 1979. https://www.510kdatabase.net/k790798/ 1979-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k790798-fetal-maturity-test-procedure-fda-510k.jpg K790798 - FETAL MATURITY TEST PROCEDURE K790798 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Jun 1979. https://www.510kdatabase.net/k790990/ 1979-06-05 monthly 0.5 https://www.510kdatabase.net/og-image/k790990-reynolds-double-hemoclip-appliers-fda-510k.jpg K790990 - REYNOLDS DOUBLE HEMOCLIP APPLIERS K790990 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Jun 1979. https://www.510kdatabase.net/k790548/ 1979-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k790548-endocardial-pacing-lead-model-476-01-fda-510k.jpg K790548 - ENDOCARDIAL PACING LEAD, MODEL 476-01 K790548 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Jun 1979. https://www.510kdatabase.net/k790826/ 1979-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k790826-coagulation-arp-fda-510k.jpg K790826 - COAGULATION ARP K790826 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared May 1979. https://www.510kdatabase.net/k790850/ 1979-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k790850-tens-single-use-electrode-fda-510k.jpg K790850 - T.E.N.S.* SINGLE-USE ELECTRODE K790850 is a FDA 510(k) cleared neurology medical device. Manufacturer: 3M Company. Cleared May 1979. https://www.510kdatabase.net/k790686/ 1979-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k790686-emit-cfa-thyroxine-assay-fda-510k.jpg K790686 - EMIT CFA THYROXINE ASSAY K790686 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared May 1979. https://www.510kdatabase.net/k790766/ 1979-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k790766-medtronic-models-69076901-fda-510k.jpg K790766 - MEDTRONIC MODELS 6907/6901 K790766 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared May 1979. https://www.510kdatabase.net/k790790/ 1979-05-25 monthly 0.5 https://www.510kdatabase.net/og-image/k790790-pisces-selector-x-fda-510k.jpg K790790 - PISCES-SELECTOR X K790790 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared May 1979. https://www.510kdatabase.net/k790646/ 1979-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k790646-helena-quiplate-system-fda-510k.jpg K790646 - HELENA QUIPLATE SYSTEM K790646 is a FDA 510(k) cleared immunology medical device. Manufacturer: Helena Laboratories. Cleared May 1979. https://www.510kdatabase.net/k790724/ 1979-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k790724-enzymatic-determination-fda-510k.jpg K790724 - ENZYMATIC DETERMINATION K790724 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared May 1979. https://www.510kdatabase.net/k790760/ 1979-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k790760-reagent-system-350hdl-sigma-procedure-fda-510k.jpg K790760 - REAGENT SYSTEM #350HDL, SIGMA PROCEDURE K790760 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared May 1979. https://www.510kdatabase.net/k790899/ 1979-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k790899-bactec-fda-510k.jpg K790899 - BACTEC K790899 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared May 1979. https://www.510kdatabase.net/k790941/ 1979-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k790941-dtt-lock-screw-inserter-fda-510k.jpg K790941 - D.T.T. LOCK SCREW INSERTER K790941 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared May 1979. https://www.510kdatabase.net/k790360/ 1979-05-22 monthly 0.5 https://www.510kdatabase.net/og-image/k790360-quantazyme-toxoplasma-fda-510k.jpg K790360 - QUANTAZYME TOXOPLASMA K790360 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bio-Rad. Cleared May 1979. https://www.510kdatabase.net/k790598/ 1979-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k790598-ruwa-finishing-strips-fda-510k.jpg K790598 - RUWA FINISHING STRIPS K790598 is a FDA 510(k) cleared dental medical device. Manufacturer: Howmedica Corp.. Cleared May 1979. https://www.510kdatabase.net/k790599/ 1979-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k790599-ruwa-matrix-strips-fda-510k.jpg K790599 - RUWA MATRIX STRIPS K790599 is a FDA 510(k) cleared dental medical device. Manufacturer: Howmedica Corp.. Cleared May 1979. https://www.510kdatabase.net/k790600/ 1979-05-21 monthly 0.5 https://www.510kdatabase.net/og-image/k790600-howmedica-strip-crown-fda-510k.jpg K790600 - HOWMEDICA STRIP CROWN K790600 is a FDA 510(k) cleared dental medical device. Manufacturer: Howmedica Corp.. Cleared May 1979. https://www.510kdatabase.net/k790320/ 1979-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k790320-delta-lite-fda-510k.jpg K790320 - DELTA-LITE K790320 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared May 1979. https://www.510kdatabase.net/k790690/ 1979-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k790690-omni-stanicor-theta-model-217-fda-510k.jpg K790690 - OMNI-STANICOR-(THETA) MODEL 217 K790690 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared May 1979. https://www.510kdatabase.net/k790315/ 1979-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k790315-blood-cell-separator-system-cs3000-fda-510k.jpg K790315 - BLOOD CELL SEPARATOR SYSTEM CS3000 K790315 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared May 1979. https://www.510kdatabase.net/k790581/ 1979-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k790581-chromatography-tubes-fda-510k.jpg K790581 - CHROMATOGRAPHY TUBES K790581 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared May 1979. https://www.510kdatabase.net/k790829/ 1979-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k790829-emit-gentamicin-assay-fda-510k.jpg K790829 - EMIT GENTAMICIN ASSAY K790829 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared May 1979. https://www.510kdatabase.net/k790830/ 1979-05-15 monthly 0.5 https://www.510kdatabase.net/og-image/k790830-emit-gentamicin-control-fda-510k.jpg K790830 - EMIT GENTAMICIN CONTROL K790830 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared May 1979. https://www.510kdatabase.net/k782008/ 1979-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k782008-dressing-environ-wound-fda-510k.jpg K782008 - DRESSING, ENVIRON WOUND K782008 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Abbott Laboratories. Cleared May 1979. https://www.510kdatabase.net/k790762/ 1979-05-14 monthly 0.5 https://www.510kdatabase.net/og-image/k790762-platform-tcck-total-knee-fda-510k.jpg K790762 - PLATFORM TCCK TOTAL KNEE K790762 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared May 1979. https://www.510kdatabase.net/k790365/ 1979-05-11 monthly 0.5 https://www.510kdatabase.net/og-image/k790365-fluid-measurement-stand-fda-510k.jpg K790365 - FLUID MEASUREMENT STAND K790365 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Hewlett-Packard Co.. Cleared May 1979. https://www.510kdatabase.net/k790219/ 1979-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k790219-prothesis-retained-geometric-knee-fda-510k.jpg K790219 - PROTHESIS, RETAINED GEOMETRIC KNEE K790219 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared May 1979. https://www.510kdatabase.net/k790731/ 1979-05-08 monthly 0.5 https://www.510kdatabase.net/og-image/k790731-oxygen-humidifier-kit-fda-510k.jpg K790731 - OXYGEN HUMIDIFIER KIT K790731 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Abbott Laboratories. Cleared May 1979. https://www.510kdatabase.net/k790514/ 1979-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k790514-i-netilmicin-ria-kit-fda-510k.jpg K790514 - I NETILMICIN RIA KIT K790514 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared May 1979. https://www.510kdatabase.net/k790543/ 1979-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k790543-the-abbott-executive-fda-510k.jpg K790543 - THE ABBOTT EXECUTIVE K790543 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared May 1979. https://www.510kdatabase.net/k790735/ 1979-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k790735-emit-tox-serum-calibrators-fda-510k.jpg K790735 - EMIT-TOX SERUM CALIBRATORS K790735 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared May 1979. https://www.510kdatabase.net/k790533/ 1979-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k790533-hd-capillary-film-dialyzer-model-1001-fda-510k.jpg K790533 - HD CAPILLARY FILM DIALYZER, MODEL 1001 K790533 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared May 1979. https://www.510kdatabase.net/k790591/ 1979-05-02 monthly 0.5 https://www.510kdatabase.net/og-image/k790591-hemodialysis-blood-circuit-fda-510k.jpg K790591 - HEMODIALYSIS BLOOD CIRCUIT K790591 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared May 1979. https://www.510kdatabase.net/k790297/ 1979-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k790297-detection-system-ms-2-electrochemical-fda-510k.jpg K790297 - DETECTION SYSTEM, MS-2 ELECTROCHEMICAL K790297 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1979. https://www.510kdatabase.net/k790654/ 1979-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k790654-closed-wound-vacuum-drainage-system-fda-510k.jpg K790654 - CLOSED WOUND VACUUM DRAINAGE SYSTEM K790654 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: 3M Company. Cleared Apr 1979. https://www.510kdatabase.net/k790736/ 1979-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k790736-emit-tox-serum-benzodiazepine-assay-fda-510k.jpg K790736 - EMIT-TOX SERUM BENZODIAZEPINE ASSAY K790736 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Apr 1979. https://www.510kdatabase.net/k790739/ 1979-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k790739-quinton-model-530x-ecg-data-cart-fda-510k.jpg K790739 - QUINTON MODEL 530X ECG DATA CART K790739 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Apr 1979. https://www.510kdatabase.net/k782013/ 1979-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k782013-gono-cell-fda-510k.jpg K782013 - GONO-CELL K782013 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1979. https://www.510kdatabase.net/k790489/ 1979-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k790489-microview-fda-510k.jpg K790489 - MICROVIEW K790489 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Apr 1979. https://www.510kdatabase.net/k790583/ 1979-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k790583-quik-column-methodology-fda-510k.jpg K790583 - QUIK COLUMN METHODOLOGY K790583 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Apr 1979. https://www.510kdatabase.net/k790629/ 1979-04-23 monthly 0.5 https://www.510kdatabase.net/og-image/k790629-kodak-gray-tone-imaging-film-fda-510k.jpg K790629 - KODAK GRAY TONE IMAGING FILM K790629 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Apr 1979. https://www.510kdatabase.net/k790344/ 1979-04-17 monthly 0.5 https://www.510kdatabase.net/og-image/k790344-bipolar-pernenous-ventricular-lead-fda-510k.jpg K790344 - BIPOLAR PERNENOUS VENTRICULAR LEAD K790344 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Apr 1979. https://www.510kdatabase.net/k790462/ 1979-04-16 monthly 0.5 https://www.510kdatabase.net/og-image/k790462-medtronic-model-6972-fda-510k.jpg K790462 - MEDTRONIC MODEL 6972 K790462 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Apr 1979. https://www.510kdatabase.net/k790212/ 1979-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k790212-cordia-t-fda-510k.jpg K790212 - CORDIA T K790212 is a FDA 510(k) cleared immunology medical device. Manufacturer: Cordis Corp.. Cleared Apr 1979. https://www.510kdatabase.net/k790340/ 1979-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k790340-delta-rol-fda-510k.jpg K790340 - DELTA-ROL K790340 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Apr 1979. https://www.510kdatabase.net/k790465/ 1979-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k790465-knee-compression-hook-system-fda-510k.jpg K790465 - KNEE COMPRESSION HOOK SYSTEM K790465 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Apr 1979. https://www.510kdatabase.net/k790067/ 1979-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k790067-flow-dialyzer-cf-2300-capillary-fda-510k.jpg K790067 - FLOW DIALYZER, CF 2300 CAPILLARY K790067 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Apr 1979. https://www.510kdatabase.net/k790379/ 1979-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k790379-sep-t-vac-suction-cannister-w-tubing-fda-510k.jpg K790379 - SEP-T-VAC SUCTION CANNISTER W/ TUBING K790379 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Sherwood Medical Co.. Cleared Apr 1979. https://www.510kdatabase.net/k790501/ 1979-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k790501-pediatric-osteotomy-system-fda-510k.jpg K790501 - PEDIATRIC OSTEOTOMY SYSTEM K790501 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Apr 1979. https://www.510kdatabase.net/k790283/ 1979-04-06 monthly 0.5 https://www.510kdatabase.net/og-image/k790283-pillow-carter-arm-elevation-fda-510k.jpg K790283 - PILLOW, CARTER ARM ELEVATION K790283 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Depuy, Inc.. Cleared Apr 1979. https://www.510kdatabase.net/k790329/ 1979-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k790329-a-gent-hdl-reagent-fda-510k.jpg K790329 - A-GENT-HDL REAGENT K790329 is a FDA 510(k) cleared immunology medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1979. https://www.510kdatabase.net/k790341/ 1979-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k790341-delta-net-fda-510k.jpg K790341 - DELTA-NET K790341 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Apr 1979. https://www.510kdatabase.net/k790366/ 1979-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k790366-urine-culture-kit-fda-510k.jpg K790366 - URINE CULTURE KIT K790366 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1979. https://www.510kdatabase.net/k790376/ 1979-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k790376-dupont-aca-ckmb-verifiers-fda-510k.jpg K790376 - DUPONT ACA CKMB VERIFIERS K790376 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Apr 1979. https://www.510kdatabase.net/k790423/ 1979-04-04 monthly 0.5 https://www.510kdatabase.net/og-image/k790423-factor-v-deficient-fda-510k.jpg K790423 - FACTOR V DEFICIENT K790423 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Chemical Co.. Cleared Apr 1979. https://www.510kdatabase.net/k790331/ 1979-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k790331-zimmer-surgical-instrument-lubricant-fda-510k.jpg K790331 - ZIMMER SURGICAL INSTRUMENT LUBRICANT K790331 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Zimmer, Inc.. Cleared Apr 1979. https://www.510kdatabase.net/k790454/ 1979-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k790454-model-78801a-patient-monitors-fda-510k.jpg K790454 - MODEL 78801A PATIENT MONITORS K790454 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Apr 1979. https://www.510kdatabase.net/k790479/ 1979-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k790479-a-gent-immunoglobuline-test-system-fda-510k.jpg K790479 - A-GENT IMMUNOGLOBULINE TEST SYSTEM K790479 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1979. https://www.510kdatabase.net/k790071/ 1979-04-02 monthly 0.5 https://www.510kdatabase.net/og-image/k790071-endoscope-and-accessories-fda-510k.jpg K790071 - ENDOSCOPE AND ACCESSORIES K790071 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Corp.. Cleared Apr 1979. https://www.510kdatabase.net/k790074/ 1979-03-29 monthly 0.5 https://www.510kdatabase.net/og-image/k790074-medtronic-model-6971-fda-510k.jpg K790074 - MEDTRONIC MODEL 6971 K790074 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Mar 1979. https://www.510kdatabase.net/k790425/ 1979-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k790425-ionescu-shiley-composite-conduit-pulmoni-fda-510k.jpg K790425 - IONESCU-SHILEY COMPOSITE CONDUIT-PULMONI K790425 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Mar 1979. https://www.510kdatabase.net/k790223/ 1979-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k790223-dialyzer-cd-800-coil-fda-510k.jpg K790223 - DIALYZER, CD-800 COIL K790223 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Mar 1979. https://www.510kdatabase.net/k790274/ 1979-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k790274-bg-proximal-femur-fda-510k.jpg K790274 - BG PROXIMAL FEMUR K790274 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Mar 1979. https://www.510kdatabase.net/k790463/ 1979-03-26 monthly 0.5 https://www.510kdatabase.net/og-image/k790463-modu-set-collimotor-fda-510k.jpg K790463 - MODU-SET COLLIMOTOR K790463 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medtronic Vascular. Cleared Mar 1979. https://www.510kdatabase.net/k782021/ 1979-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k782021-av-fistula-needle-set-fda-510k.jpg K782021 - A.V. FISTULA NEEDLE SET K782021 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Mar 1979. https://www.510kdatabase.net/k790183/ 1979-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k790183-portable-wheelchair-carrying-case-fda-510k.jpg K790183 - PORTABLE WHEELCHAIR & CARRYING CASE K790183 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Mar 1979. https://www.510kdatabase.net/k790403/ 1979-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k790403-emit-quinidine-assay-fda-510k.jpg K790403 - EMIT QUINIDINE ASSAY K790403 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Mar 1979. https://www.510kdatabase.net/k790404/ 1979-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k790404-dtt-system-fda-510k.jpg K790404 - DTT SYSTEM K790404 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Mar 1979. https://www.510kdatabase.net/k790418/ 1979-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k790418-model-8100-pre-filled-intrauterine-fda-510k.jpg K790418 - MODEL 8100 PRE-FILLED INTRAUTERINE K790418 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Mar 1979. https://www.510kdatabase.net/k790303/ 1979-03-19 monthly 0.5 https://www.510kdatabase.net/og-image/k790303-emit-auto-digoxin-assay-fda-510k.jpg K790303 - EMIT AUTO DIGOXIN ASSAY K790303 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Mar 1979. https://www.510kdatabase.net/k790277/ 1979-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k790277-quick-check-fda-510k.jpg K790277 - QUICK-CHECK K790277 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Mar 1979. https://www.510kdatabase.net/k790413/ 1979-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k790413-heifetz-aneurysm-clip-lmm-blade-fda-510k.jpg K790413 - HEIFETZ ANEURYSM CLIP, LMM BLADE K790413 is a FDA 510(k) cleared neurology medical device. Manufacturer: Edward Weck, Inc.. Cleared Mar 1979. https://www.510kdatabase.net/k790211/ 1979-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k790211-dehydrogenose-glucose-phosphate-fda-510k.jpg K790211 - DEHYDROGENOSE, GLUCOSE PHOSPHATE K790211 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Mar 1979. https://www.510kdatabase.net/k790402/ 1979-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k790402-emit-quinidine-control-fda-510k.jpg K790402 - EMIT-QUINIDINE CONTROL K790402 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Mar 1979. https://www.510kdatabase.net/k790088/ 1979-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k790088-aca-creatine-kinase-isoenzymes-fda-510k.jpg K790088 - ACA CREATINE KINASE ISOENZYMES K790088 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Mar 1979. https://www.510kdatabase.net/k790092/ 1979-03-12 monthly 0.5 https://www.510kdatabase.net/og-image/k790092-uric-acid-bound-enzyme-fda-510k.jpg K790092 - URIC ACID, BOUND ENZYME K790092 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Mar 1979. https://www.510kdatabase.net/k790348/ 1979-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k790348-anametric-tibial-component-metal-tray-fda-510k.jpg K790348 - ANAMETRIC TIBIAL COMPONENT METAL TRAY K790348 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Mar 1979. https://www.510kdatabase.net/k790349/ 1979-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k790349-total-condylar-knee-prosthesis-fda-510k.jpg K790349 - TOTAL CONDYLAR KNEE PROSTHESIS K790349 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Mar 1979. https://www.510kdatabase.net/k790350/ 1979-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k790350-posterior-cruciate-condylar-tibial-fda-510k.jpg K790350 - POSTERIOR CRUCIATE CONDYLAR TIBIAL K790350 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Mar 1979. https://www.510kdatabase.net/k782032/ 1979-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k782032-unitest-amylase-fda-510k.jpg K782032 - UNITEST AMYLASE K782032 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Mar 1979. https://www.510kdatabase.net/k782156/ 1979-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k782156-unitest-creatine-kinase-fda-510k.jpg K782156 - UNITEST CREATINE KINASE K782156 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Mar 1979. https://www.510kdatabase.net/k790255/ 1979-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k790255-emit-aed-assays-3500-computer-directed-fda-510k.jpg K790255 - EMIT AED ASSAYS 3500 COMPUTER DIRECTED K790255 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Mar 1979. https://www.510kdatabase.net/k790256/ 1979-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k790256-emit-theophylline-assay-fda-510k.jpg K790256 - EMIT THEOPHYLLINE ASSAY K790256 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Mar 1979. https://www.510kdatabase.net/k782034/ 1979-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k782034-infusion-pump-model-as5-fda-510k.jpg K782034 - INFUSION PUMP, MODEL AS*5 K782034 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Feb 1979. https://www.510kdatabase.net/k790172/ 1979-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k790172-bk-5098-tilt-table-strap-fda-510k.jpg K790172 - BK-5098 TILT TABLE STRAP K790172 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Fred Sammons, Inc.. Cleared Feb 1979. https://www.510kdatabase.net/k790261/ 1979-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k790261-medtronic-temptron-fda-510k.jpg K790261 - MEDTRONIC TEMPTRON K790261 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Feb 1979. https://www.510kdatabase.net/k790090/ 1979-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k790090-determination-of-antithrombin-iii-885-fda-510k.jpg K790090 - DETERMINATION OF ANTITHROMBIN III, 885 K790090 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Chemical Co.. Cleared Feb 1979. https://www.510kdatabase.net/k790112/ 1979-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k790112-mobile-units-iiiiiiiv-fda-510k.jpg K790112 - MOBILE UNITS, I,II,III,IV K790112 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Feb 1979. https://www.510kdatabase.net/k790127/ 1979-02-26 monthly 0.5 https://www.510kdatabase.net/og-image/k790127-cement-ceramco-fda-510k.jpg K790127 - CEMENT, CERAMCO K790127 is a FDA 510(k) cleared dental medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Feb 1979. https://www.510kdatabase.net/k782072/ 1979-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k782072-quinton-status-1000-fda-510k.jpg K782072 - QUINTON STATUS 1000 K782072 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Feb 1979. https://www.510kdatabase.net/k790144/ 1979-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k790144-telemetry-system-315-fda-510k.jpg K790144 - TELEMETRY SYSTEM 315 K790144 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Feb 1979. https://www.510kdatabase.net/k790258/ 1979-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k790258-movable-core-safety-guide-fda-510k.jpg K790258 - MOVABLE CORE SAFETY GUIDE K790258 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Feb 1979. https://www.510kdatabase.net/k782151/ 1979-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k782151-artificial-kidney-c-dak-06d-fda-510k.jpg K782151 - ARTIFICIAL KIDNEY, C-DAK 0.6D K782151 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Feb 1979. https://www.510kdatabase.net/k790055/ 1979-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k790055-tubing-dynacor-universal-fda-510k.jpg K790055 - TUBING, DYNACOR UNIVERSAL K790055 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Feb 1979. https://www.510kdatabase.net/k790173/ 1979-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k790173-bk-5371-gad-19-bout-personal-mobil-aid-fda-510k.jpg K790173 - BK-5371 GAD-19-BOUT PERSONAL MOBIL AID K790173 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Feb 1979. https://www.510kdatabase.net/k790175/ 1979-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k790175-semi-reclining-bath-chari-belt-fda-510k.jpg K790175 - SEMI-RECLINING BATH CHARI & BELT K790175 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Feb 1979. https://www.510kdatabase.net/k790307/ 1979-02-22 monthly 0.5 https://www.510kdatabase.net/og-image/k790307-flexible-reamer-guide-wire-system-fda-510k.jpg K790307 - FLEXIBLE REAMER, GUIDE WIRE SYSTEM K790307 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 3M Company. Cleared Feb 1979. https://www.510kdatabase.net/k790134/ 1979-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k790134-radiotherapy-treatment-fda-510k.jpg K790134 - RADIOTHERAPY TREATMENT K790134 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Feb 1979. https://www.510kdatabase.net/k790275/ 1979-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k790275-gun-exeter-cement-fda-510k.jpg K790275 - GUN, EXETER CEMENT K790275 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Feb 1979. https://www.510kdatabase.net/k790139/ 1979-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k790139-monitor-office-model-140-fda-510k.jpg K790139 - MONITOR, OFFICE MODEL 140 K790139 is a FDA 510(k) cleared radiology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Feb 1979. https://www.510kdatabase.net/k782126/ 1979-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k782126-ria-kit-sisomicin-fda-510k.jpg K782126 - RIA KIT, SISOMICIN K782126 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Feb 1979. https://www.510kdatabase.net/k790110/ 1979-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k790110-preparation-dupont-fda-510k.jpg K790110 - PREPARATION, DUPONT K790110 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Feb 1979. https://www.510kdatabase.net/k790182/ 1979-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k790182-2-velcro-splint-strap-fda-510k.jpg K790182 - 2 VELCRO SPLINT STRAP K790182 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Feb 1979. https://www.510kdatabase.net/k790170/ 1979-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k790170-bk-1472-spatula-spoon-fda-510k.jpg K790170 - BK-1472 SPATULA SPOON K790170 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Feb 1979. https://www.510kdatabase.net/k790180/ 1979-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k790180-platform-splints-fda-510k.jpg K790180 - PLATFORM SPLINTS K790180 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Feb 1979. https://www.510kdatabase.net/k790181/ 1979-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k790181-soft-splint-straps-fda-510k.jpg K790181 - SOFT SPLINT STRAPS K790181 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Feb 1979. https://www.510kdatabase.net/k790259/ 1979-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k790259-sterile-disposable-knife-fda-510k.jpg K790259 - STERILE DISPOSABLE KNIFE K790259 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intermedics, Inc.. Cleared Feb 1979. https://www.510kdatabase.net/k790262/ 1979-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k790262-universal-external-fixation-assembly-fda-510k.jpg K790262 - UNIVERSAL EXTERNAL FIXATION ASSEMBLY K790262 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Feb 1979. https://www.510kdatabase.net/k781338/ 1979-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k781338-beaver-cataract-cyroxtractor-fda-510k.jpg K781338 - BEAVER CATARACT CYROXTRACTOR K781338 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Edward Weck, Inc.. Cleared Feb 1979. https://www.510kdatabase.net/k790102/ 1979-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k790102-model-556-01-cryoextractor-fda-510k.jpg K790102 - MODEL 556-01 CRYOEXTRACTOR K790102 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Intermedics, Inc.. Cleared Feb 1979. https://www.510kdatabase.net/k790238/ 1979-02-12 monthly 0.5 https://www.510kdatabase.net/og-image/k790238-transverse-traction-assembly-fda-510k.jpg K790238 - TRANSVERSE TRACTION ASSEMBLY K790238 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Feb 1979. https://www.510kdatabase.net/k781792/ 1979-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k781792-pressurizer-exeter-cement-fda-510k.jpg K781792 - PRESSURIZER, EXETER CEMENT K781792 is a FDA 510(k) cleared pathology medical device. Manufacturer: Howmedica Corp.. Cleared Feb 1979. https://www.510kdatabase.net/k781961/ 1979-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k781961-control-strip-for-visual-urinalysis-fda-510k.jpg K781961 - CONTROL STRIP FOR VISUAL URINALYSIS K781961 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Feb 1979. https://www.510kdatabase.net/k790014/ 1979-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k790014-bipolar-stanicor-lambda-model-236235-fda-510k.jpg K790014 - BIPOLAR, STANICOR LAMBDA MODEL 236,235 K790014 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Feb 1979. https://www.510kdatabase.net/k790086/ 1979-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k790086-needle-trucare-vacutainer-fda-510k.jpg K790086 - NEEDLE, TRUCARE VACUTAINER K790086 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Feb 1979. https://www.510kdatabase.net/k790171/ 1979-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k790171-bk-2084-plastic-sock-and-stocking-aid-fda-510k.jpg K790171 - BK-2084 PLASTIC SOCK AND STOCKING AID K790171 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Feb 1979. https://www.510kdatabase.net/k790174/ 1979-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k790174-bk-6021-condom-catheter-holder-fda-510k.jpg K790174 - BK-6021 CONDOM CATHETER HOLDER K790174 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fred Sammons, Inc.. Cleared Feb 1979. https://www.510kdatabase.net/k790176/ 1979-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k790176-adjustable-height-desk-arm-lap-tray-kit-fda-510k.jpg K790176 - ADJUSTABLE HEIGHT DESK ARM LAP TRAY KIT K790176 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Feb 1979. https://www.510kdatabase.net/k790177/ 1979-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k790177-ashtray-for-wheelchair-fda-510k.jpg K790177 - ASHTRAY FOR WHEELCHAIR K790177 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Feb 1979. https://www.510kdatabase.net/k790178/ 1979-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k790178-water-powered-bath-chair-lift-fda-510k.jpg K790178 - WATER POWERED BATH CHAIR LIFT K790178 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Feb 1979. https://www.510kdatabase.net/k790179/ 1979-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k790179-gair-training-belt-fda-510k.jpg K790179 - GAIR TRAINING BELT K790179 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Feb 1979. https://www.510kdatabase.net/k782137/ 1979-02-07 monthly 0.5 https://www.510kdatabase.net/og-image/k782137-medtronic-model-3797-electrode-fda-510k.jpg K782137 - MEDTRONIC MODEL 3797 ELECTRODE K782137 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Feb 1979. https://www.510kdatabase.net/k790123/ 1979-02-06 monthly 0.5 https://www.510kdatabase.net/og-image/k790123-stimulator-battery-powered-fda-510k.jpg K790123 - STIMULATOR, BATTERY POWERED K790123 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Intermedics, Inc.. Cleared Feb 1979. https://www.510kdatabase.net/k790056/ 1979-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k790056-cannulas-dynacors-nasal-oxygen-fda-510k.jpg K790056 - CANNULAS, DYNACOR'S NASAL OXYGEN K790056 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Medline Industries, Inc.. Cleared Feb 1979. https://www.510kdatabase.net/k790057/ 1979-02-05 monthly 0.5 https://www.510kdatabase.net/og-image/k790057-catheter-oxygen-fda-510k.jpg K790057 - CATHETER, OXYGEN K790057 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Medline Industries, Inc.. Cleared Feb 1979. https://www.510kdatabase.net/k781497/ 1979-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k781497-lifeline-pacing-lead-model-465-01-fda-510k.jpg K781497 - LIFELINE PACING LEAD MODEL 465-01 K781497 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Feb 1979. https://www.510kdatabase.net/k781498/ 1979-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k781498-lifeline-bipolar-pacing-lead-mod-466-01-fda-510k.jpg K781498 - LIFELINE BIPOLAR PACING LEAD MOD. 466-01 K781498 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Feb 1979. https://www.510kdatabase.net/k781499/ 1979-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k781499-lifeline-pacing-lead-model-467-01-fda-510k.jpg K781499 - LIFELINE PACING LEAD MODEL 467-01 K781499 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Feb 1979. https://www.510kdatabase.net/k781525/ 1979-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k781525-endocaridal-pacing-lead-unipolar-477-fda-510k.jpg K781525 - ENDOCARIDAL PACING LEAD UNIPOLAR 477 K781525 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Feb 1979. https://www.510kdatabase.net/k781570/ 1979-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k781570-sutureless-muocardine-pacing-leads-471-fda-510k.jpg K781570 - SUTURELESS MUOCARDINE PACING LEADS 471 K781570 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Feb 1979. https://www.510kdatabase.net/k782015/ 1979-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k782015-a-gent-ck-mb-fda-510k.jpg K782015 - A-GENT CK-MB K782015 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Feb 1979. https://www.510kdatabase.net/k782079/ 1979-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k782079-electrode-system-quik-prep-fda-510k.jpg K782079 - ELECTRODE SYSTEM, QUIK-PREP K782079 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Feb 1979. https://www.510kdatabase.net/k782085/ 1979-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k782085-emit-thyroxine-assay-fda-510k.jpg K782085 - EMIT THYROXINE ASSAY K782085 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Feb 1979. https://www.510kdatabase.net/k790002/ 1979-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k790002-pregnancy-test-kit-daisy-2-in-home-fda-510k.jpg K790002 - PREGNANCY TEST KIT, DAISY 2 IN HOME K790002 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Feb 1979. https://www.510kdatabase.net/k790010/ 1979-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k790010-manifold-disposable-3-valve-fda-510k.jpg K790010 - MANIFOLD, DISPOSABLE 3 VALVE K790010 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Cordis Corp.. Cleared Feb 1979. https://www.510kdatabase.net/k782138/ 1979-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k782138-monitor-beckman-lb-3co2-fda-510k.jpg K782138 - MONITOR, BECKMAN LB-3CO2 K782138 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jan 1979. https://www.510kdatabase.net/k790221/ 1979-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k790221-pulse-generator-cyberlith-implantable-fda-510k.jpg K790221 - PULSE GENERATOR, CYBERLITH IMPLANTABLE K790221 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Jan 1979. https://www.510kdatabase.net/k782068/ 1979-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k782068-mvs-unit-model-seu-8-and-deu-8-80-fda-510k.jpg K782068 - MVS UNIT, MODEL SEU-8 AND DEU-8, 80 K782068 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jan 1979. https://www.510kdatabase.net/k790038/ 1979-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k790038-disk-beta-lactam-fda-510k.jpg K790038 - DISK, BETA-LACTAM K790038 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Remel Co.. Cleared Jan 1979. https://www.510kdatabase.net/k790046/ 1979-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k790046-g-hb-quik-column-control-fda-510k.jpg K790046 - G-HB QUIK COLUMN CONTROL K790046 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Jan 1979. https://www.510kdatabase.net/k790098/ 1979-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k790098-isolation-sleeve-model-349-01-fda-510k.jpg K790098 - ISOLATION SLEEVE, MODEL 349-01 K790098 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Jan 1979. https://www.510kdatabase.net/k790099/ 1979-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k790099-isolation-sleeve-model-347-01-fda-510k.jpg K790099 - ISOLATION SLEEVE, MODEL 347-01 K790099 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Jan 1979. https://www.510kdatabase.net/k790100/ 1979-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k790100-isolation-sleeve-model-348-01-fda-510k.jpg K790100 - ISOLATION SLEEVE, MODEL 348-01 K790100 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Jan 1979. https://www.510kdatabase.net/k790101/ 1979-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k790101-isolation-sleeve-model-346-01-fda-510k.jpg K790101 - ISOLATION SLEEVE, MODEL 346-01 K790101 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Jan 1979. https://www.510kdatabase.net/k780885/ 1979-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k780885-cordia-r-fda-510k.jpg K780885 - CORDIA R K780885 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Cordis Corp.. Cleared Jan 1979. https://www.510kdatabase.net/k781806/ 1979-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k781806-reagent-system-inorganic-phosphorus-fda-510k.jpg K781806 - REAGENT SYSTEM, INORGANIC PHOSPHORUS K781806 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Jan 1979. https://www.510kdatabase.net/k781813/ 1979-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k781813-solution-administration-tip-protector-fda-510k.jpg K781813 - SOLUTION ADMINISTRATION, TIP PROTECTOR K781813 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Jan 1979. https://www.510kdatabase.net/k781886/ 1979-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k781886-dialysate-delivery-system-fda-510k.jpg K781886 - DIALYSATE DELIVERY SYSTEM K781886 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Jan 1979. https://www.510kdatabase.net/k782003/ 1979-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k782003-band-aid-adhesive-bandages-fda-510k.jpg K782003 - BAND AID* ADHESIVE BANDAGES K782003 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jan 1979. https://www.510kdatabase.net/k782035/ 1979-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k782035-hemespec-fda-510k.jpg K782035 - HEMESPEC K782035 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Jan 1979. https://www.510kdatabase.net/k782134/ 1979-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k782134-filter-for-hyperalimentation-set-fda-510k.jpg K782134 - FILTER FOR HYPERALIMENTATION SET K782134 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Jan 1979. https://www.510kdatabase.net/k781939/ 1979-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k781939-reagent-kit-triglycerides-fda-510k.jpg K781939 - REAGENT KIT, TRIGLYCERIDES K781939 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jan 1979. https://www.510kdatabase.net/k781946/ 1979-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k781946-ria-kit-ferritin-solid-phase-fda-510k.jpg K781946 - RIA KIT, FERRITIN SOLID PHASE K781946 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jan 1979. https://www.510kdatabase.net/k781957/ 1979-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k781957-analytical-test-pack-primidone-fda-510k.jpg K781957 - ANALYTICAL TEST PACK, PRIMIDONE K781957 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Jan 1979. https://www.510kdatabase.net/k781958/ 1979-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k781958-analytical-test-pack-carbamazepine-fda-510k.jpg K781958 - ANALYTICAL TEST PACK, CARBAMAZEPINE K781958 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Jan 1979. https://www.510kdatabase.net/k782014/ 1979-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k782014-analyzer-aba-200-fda-510k.jpg K782014 - ANALYZER ABA-200 K782014 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jan 1979. https://www.510kdatabase.net/k782084/ 1979-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k782084-emit-procainamide-control-set-fda-510k.jpg K782084 - EMIT PROCAINAMIDE CONTROL SET K782084 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jan 1979. https://www.510kdatabase.net/k782123/ 1979-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k782123-multiplicity-of-products-fda-510k.jpg K782123 - MULTIPLICITY OF PRODUCTS K782123 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jan 1979. https://www.510kdatabase.net/k782125/ 1979-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k782125-ria-kit-kanamycin-fda-510k.jpg K782125 - RIA KIT, KANAMYCIN K782125 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jan 1979. https://www.510kdatabase.net/k781827/ 1979-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k781827-control-set-emit-methotrexate-fda-510k.jpg K781827 - CONTROL SET, EMIT METHOTREXATE K781827 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Jan 1979. https://www.510kdatabase.net/k781850/ 1979-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k781850-ria-quantimune-e3-fda-510k.jpg K781850 - RIA, QUANTIMUNE E3 K781850 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bio-Rad. Cleared Jan 1979. https://www.510kdatabase.net/k781921/ 1979-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k781921-bilirubin-dingle-valve-dpd-fda-510k.jpg K781921 - BILIRUBIN, DINGLE VALVE DPD K781921 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jan 1979. https://www.510kdatabase.net/k781941/ 1979-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k781941-analysis-system-prep-sample-fda-510k.jpg K781941 - ANALYSIS SYSTEM, PREP SAMPLE K781941 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Jan 1979. https://www.510kdatabase.net/k782108/ 1978-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k782108-medtronic-model-546-fda-510k.jpg K782108 - MEDTRONIC MODEL 546 K782108 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Dec 1978. https://www.510kdatabase.net/k782120/ 1978-12-27 monthly 0.5 https://www.510kdatabase.net/og-image/k782120-sponge-system-rosering-contain-count-fda-510k.jpg K782120 - SPONGE SYSTEM, ROSERING CONTAIN-COUNT K782120 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medline Industries, Inc.. Cleared Dec 1978. https://www.510kdatabase.net/k782029/ 1978-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k782029-maxi-camera-400t-fda-510k.jpg K782029 - MAXI CAMERA 400T K782029 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Dec 1978. https://www.510kdatabase.net/k781632/ 1978-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k781632-urotron-fda-510k.jpg K781632 - UROTRON K781632 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Dec 1978. https://www.510kdatabase.net/k781691/ 1978-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k781691-chemstrip-control-fda-510k.jpg K781691 - CHEMSTRIP CONTROL K781691 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Dec 1978. https://www.510kdatabase.net/k781762/ 1978-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k781762-compression-hip-screw-system-fda-510k.jpg K781762 - COMPRESSION HIP SCREW SYSTEM K781762 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Dec 1978. https://www.510kdatabase.net/k781771/ 1978-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k781771-detector-model-79875a-variable-fda-510k.jpg K781771 - DETECTOR, MODEL 79875A, VARIABLE K781771 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Dec 1978. https://www.510kdatabase.net/k781777/ 1978-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k781777-abrasive-wheels-fda-510k.jpg K781777 - ABRASIVE WHEELS K781777 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Dec 1978. https://www.510kdatabase.net/k781893/ 1978-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k781893-control-protein-electrophoresis-fda-510k.jpg K781893 - CONTROL, PROTEIN ELECTROPHORESIS K781893 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Dec 1978. https://www.510kdatabase.net/k781948/ 1978-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k781948-column-test-hemoglobin-a-fda-510k.jpg K781948 - COLUMN TEST, HEMOGLOBIN A K781948 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bio-Rad. Cleared Dec 1978. https://www.510kdatabase.net/k782047/ 1978-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k782047-processing-system-a2-image-fda-510k.jpg K782047 - PROCESSING SYSTEM, A2 IMAGE K782047 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medtronic Vascular. Cleared Dec 1978. https://www.510kdatabase.net/k782082/ 1978-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k782082-catheter-digital-positral-ii-fda-510k.jpg K782082 - CATHETER, DIGITAL POSITRAL II K782082 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 1978. https://www.510kdatabase.net/k782033/ 1978-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k782033-cardiac-care-qc-test-kit-fda-510k.jpg K782033 - CARDIAC CARE Q/C TEST KIT K782033 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Dec 1978. https://www.510kdatabase.net/k782071/ 1978-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k782071-catheter-usci-gruntzigballoon-fda-510k.jpg K782071 - CATHETER, USCI GRUNTZIG/BALLOON K782071 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 1978. https://www.510kdatabase.net/k782075/ 1978-12-14 monthly 0.5 https://www.510kdatabase.net/og-image/k782075-stimulator-model-7727-fda-510k.jpg K782075 - STIMULATOR, MODEL 7727 K782075 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Dec 1978. https://www.510kdatabase.net/k781986/ 1978-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k781986-transmitter-model-9406-and-9401-fda-510k.jpg K781986 - TRANSMITTER, MODEL 9406 AND 9401 K781986 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Dec 1978. https://www.510kdatabase.net/k781327/ 1978-12-11 monthly 0.5 https://www.510kdatabase.net/og-image/k781327-pulse-generator-model-240-external-fda-510k.jpg K781327 - PULSE GENERATOR, MODEL 240, EXTERNAL K781327 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Dec 1978. https://www.510kdatabase.net/k781569/ 1978-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k781569-nerve-locaterstimulator-fda-510k.jpg K781569 - NERVE LOCATER/STIMULATOR K781569 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Intermedics, Inc.. Cleared Dec 1978. https://www.510kdatabase.net/k781738/ 1978-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k781738-pacemaker-model-229-01-fda-510k.jpg K781738 - PACEMAKER, MODEL 229-01 K781738 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Dec 1978. https://www.510kdatabase.net/k781766/ 1978-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k781766-uterine-sound-burnett-disposable-fda-510k.jpg K781766 - UTERINE SOUND, BURNETT DISPOSABLE K781766 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 1978. https://www.510kdatabase.net/k781767/ 1978-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k781767-instrument-curnett-mini-coner-biopsy-fda-510k.jpg K781767 - INSTRUMENT CURNETT MINI-CONER BIOPSY K781767 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 1978. https://www.510kdatabase.net/k781812/ 1978-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k781812-solution-administration-flex-valve-fda-510k.jpg K781812 - SOLUTION ADMINISTRATION, FLEX VALVE K781812 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Dec 1978. https://www.510kdatabase.net/k781952/ 1978-12-07 monthly 0.5 https://www.510kdatabase.net/og-image/k781952-paper-tape-hypo-allergenic-fda-510k.jpg K781952 - PAPER TAPE, HYPO ALLERGENIC K781952 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Dec 1978. https://www.510kdatabase.net/k781000/ 1978-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k781000-phosphorus-inorganic-analysis-products-fda-510k.jpg K781000 - PHOSPHORUS (INORGANIC) ANALYSIS PRODUCTS K781000 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Dec 1978. https://www.510kdatabase.net/k781002/ 1978-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k781002-temporary-cardiac-pacing-wire-fda-510k.jpg K781002 - TEMPORARY CARDIAC PACING WIRE K781002 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ethicon, Inc.. Cleared Dec 1978. https://www.510kdatabase.net/k781630/ 1978-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k781630-ge-700-intra-oral-x-ray-system-fda-510k.jpg K781630 - GE-700 INTRA ORAL X-RAY SYSTEM K781630 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Dec 1978. https://www.510kdatabase.net/k781715/ 1978-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k781715-ruler-weck-scott-fda-510k.jpg K781715 - RULER, WECK SCOTT K781715 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Edward Weck, Inc.. Cleared Dec 1978. https://www.510kdatabase.net/k781828/ 1978-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k781828-computer-3500-gilford-system-fda-510k.jpg K781828 - COMPUTER, 3500, GILFORD SYSTEM K781828 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Dec 1978. https://www.510kdatabase.net/k781853/ 1978-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k781853-cholesterol-standards-fda-510k.jpg K781853 - CHOLESTEROL STANDARDS K781853 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Dec 1978. https://www.510kdatabase.net/k781854/ 1978-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k781854-pad-b-d-iv-cath-fda-510k.jpg K781854 - PAD, B-D I.V. CATH. K781854 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Dec 1978. https://www.510kdatabase.net/k781859/ 1978-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k781859-reagent-system-no-46-ov-for-cpk-fda-510k.jpg K781859 - REAGENT SYSTEM, NO 46-OV FOR CPK K781859 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Dec 1978. https://www.510kdatabase.net/k781934/ 1978-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k781934-processor-model-m8-fda-510k.jpg K781934 - PROCESSOR, MODEL M8 K781934 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Dec 1978. https://www.510kdatabase.net/k781955/ 1978-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k781955-gun-cement-fda-510k.jpg K781955 - GUN, CEMENT K781955 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Dec 1978. https://www.510kdatabase.net/k781990/ 1978-12-04 monthly 0.5 https://www.510kdatabase.net/og-image/k781990-cardiac-insulation-pad-fda-510k.jpg K781990 - CARDIAC INSULATION PAD K781990 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Dec 1978. https://www.510kdatabase.net/k781954/ 1978-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k781954-catheter-introducers-arterise-fda-510k.jpg K781954 - CATHETER INTRODUCERS, ARTERISE K781954 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 1978. https://www.510kdatabase.net/k781571/ 1978-11-27 monthly 0.5 https://www.510kdatabase.net/og-image/k781571-lu-arm-vascular-fda-510k.jpg K781571 - L/U ARM-VASCULAR K781571 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Nov 1978. https://www.510kdatabase.net/k781504/ 1978-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k781504-125i-aldosterone-ria-diag-kit-fda-510k.jpg K781504 - 125I-ALDOSTERONE RIA DIAG. KIT K781504 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1978. https://www.510kdatabase.net/k781838/ 1978-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k781838-calculator-with-charger-fda-510k.jpg K781838 - CALCULATOR, WITH CHARGER K781838 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 1978. https://www.510kdatabase.net/k781674/ 1978-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k781674-macro-vue-test-gentamicin-fda-510k.jpg K781674 - MACRO-VUE TEST, GENTAMICIN K781674 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Nov 1978. https://www.510kdatabase.net/k781837/ 1978-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k781837-wound-span-bridge-iii-fda-510k.jpg K781837 - WOUND SPAN BRIDGE III K781837 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Howmedica Corp.. Cleared Nov 1978. https://www.510kdatabase.net/k781662/ 1978-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k781662-ria-t3-uptake-solid-phase-fda-510k.jpg K781662 - RIA, T3 UPTAKE SOLID PHASE K781662 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Nov 1978. https://www.510kdatabase.net/k781754/ 1978-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k781754-splint-hoake-inflatable-air-fda-510k.jpg K781754 - SPLINT, HOAKE INFLATABLE AIR K781754 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Nov 1978. https://www.510kdatabase.net/k781811/ 1978-11-08 monthly 0.5 https://www.510kdatabase.net/og-image/k781811-transfer-pak-4r-9006-fda-510k.jpg K781811 - TRANSFER PAK 4R 9006 K781811 is a FDA 510(k) cleared hematology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Nov 1978. https://www.510kdatabase.net/k780573/ 1978-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k780573-technique-chromatographic-hemoglobin-fda-510k.jpg K780573 - TECHNIQUE, CHROMATOGRAPHIC, HEMOGLOBIN K780573 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Nov 1978. https://www.510kdatabase.net/k781736/ 1978-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k781736-disc-coloplast-pre-op-stoma-fda-510k.jpg K781736 - DISC, COLOPLAST PRE-OP STOMA K781736 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 1978. https://www.510kdatabase.net/k781393/ 1978-10-30 monthly 0.5 https://www.510kdatabase.net/og-image/k781393-variable-stiffness-wire-guide-fda-510k.jpg K781393 - VARIABLE STIFFNESS WIRE GUIDE K781393 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Oct 1978. https://www.510kdatabase.net/k781452/ 1978-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k781452-baylow-visual-acuity-tester-fda-510k.jpg K781452 - BAYLOW VISUAL ACUITY TESTER K781452 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Oct 1978. https://www.510kdatabase.net/k781547/ 1978-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k781547-microsurgury-visibility-background-fda-510k.jpg K781547 - MICROSURGURY VISIBILITY BACKGROUND K781547 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Oct 1978. https://www.510kdatabase.net/k781639/ 1978-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k781639-shiley-cricothyrotomy-tube-fda-510k.jpg K781639 - SHILEY CRICOTHYROTOMY TUBE K781639 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Shiley, Inc.. Cleared Oct 1978. https://www.510kdatabase.net/k781709/ 1978-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k781709-scanner-linear-fda-510k.jpg K781709 - SCANNER, LINEAR K781709 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Oct 1978. https://www.510kdatabase.net/k781716/ 1978-10-24 monthly 0.5 https://www.510kdatabase.net/og-image/k781716-blade-20-anglemicro-blade-holder-fda-510k.jpg K781716 - BLADE, 20 ANGLE/MICRO BLADE HOLDER K781716 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Oct 1978. https://www.510kdatabase.net/k781669/ 1978-10-23 monthly 0.5 https://www.510kdatabase.net/og-image/k781669-respiratory-exercisor-volume-pulse-fda-510k.jpg K781669 - RESPIRATORY EXERCISOR, VOLUME PULSE K781669 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1978. https://www.510kdatabase.net/k781568/ 1978-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k781568-pacemaker-model-251-01-fda-510k.jpg K781568 - PACEMAKER, MODEL 251-01 K781568 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Oct 1978. https://www.510kdatabase.net/k781153/ 1978-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k781153-kidney-artificial-fda-510k.jpg K781153 - KIDNEY, ARTIFICIAL K781153 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1978. https://www.510kdatabase.net/k781382/ 1978-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k781382-emit-procainamide-assay-fda-510k.jpg K781382 - EMIT PROCAINAMIDE ASSAY K781382 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Oct 1978. https://www.510kdatabase.net/k781524/ 1978-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k781524-maxiray-125-tube-unit-fda-510k.jpg K781524 - MAXIRAY 125 TUBE UNIT K781524 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Oct 1978. https://www.510kdatabase.net/k781556/ 1978-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k781556-pressure-infusion-cuff-fda-510k.jpg K781556 - PRESSURE INFUSION CUFF K781556 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1978. https://www.510kdatabase.net/k781598/ 1978-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k781598-technicon-autoslide-stainingprocessing-fda-510k.jpg K781598 - TECHNICON AUTOSLIDE STAINING/PROCESSING K781598 is a FDA 510(k) cleared hematology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Oct 1978. https://www.510kdatabase.net/k781673/ 1978-10-17 monthly 0.5 https://www.510kdatabase.net/og-image/k781673-maxi-camera-535-fda-510k.jpg K781673 - MAXI-CAMERA 535 K781673 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Oct 1978. https://www.510kdatabase.net/k781412/ 1978-10-11 monthly 0.5 https://www.510kdatabase.net/og-image/k781412-oscillating-knife-and-accessories-fda-510k.jpg K781412 - OSCILLATING KNIFE AND ACCESSORIES K781412 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Oct 1978. https://www.510kdatabase.net/k781378/ 1978-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k781378-emit-n-acetylprocainamide-assay-fda-510k.jpg K781378 - EMIT N-ACETYLPROCAINAMIDE ASSAY K781378 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Oct 1978. https://www.510kdatabase.net/k781381/ 1978-10-10 monthly 0.5 https://www.510kdatabase.net/og-image/k781381-emit-methatrexate-assay-fda-510k.jpg K781381 - EMIT METHATREXATE ASSAY K781381 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Dade Behring, Inc.. Cleared Oct 1978. https://www.510kdatabase.net/k781208/ 1978-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k781208-generators-pulse-models-59885989-fda-510k.jpg K781208 - GENERATORS, PULSE, MODELS 5988/5989 K781208 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Oct 1978. https://www.510kdatabase.net/k781252/ 1978-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k781252-generator-pulse-model-5997-fda-510k.jpg K781252 - GENERATOR, PULSE, MODEL 5997 K781252 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Oct 1978. https://www.510kdatabase.net/k781432/ 1978-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k781432-stat-ultra-violet-liquid-fda-510k.jpg K781432 - STAT ULTRA VIOLET LIQUID K781432 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Oct 1978. https://www.510kdatabase.net/k781436/ 1978-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k781436-delta-test-assay-hdl-chloresterol-fda-510k.jpg K781436 - DELTA TEST ASSAY, HDL CHLORESTEROL K781436 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1978. https://www.510kdatabase.net/k781442/ 1978-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k781442-beckman-astra-system-fda-510k.jpg K781442 - BECKMAN ASTRA SYSTEM K781442 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Oct 1978. https://www.510kdatabase.net/k781501/ 1978-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k781501-enzac-incubator-fda-510k.jpg K781501 - ENZAC INCUBATOR K781501 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1978. https://www.510kdatabase.net/k781533/ 1978-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k781533-smaggt-fda-510k.jpg K781533 - SMA/GGT K781533 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Oct 1978. https://www.510kdatabase.net/k781538/ 1978-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k781538-single-vial-ldh-l-tris-fda-510k.jpg K781538 - SINGLE VIAL LDH-L TRIS K781538 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Oct 1978. https://www.510kdatabase.net/k781303/ 1978-10-02 monthly 0.5 https://www.510kdatabase.net/og-image/k781303-bio-pro-unit-fda-510k.jpg K781303 - BIO-PRO UNIT K781303 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1978. https://www.510kdatabase.net/k781098/ 1978-09-29 monthly 0.5 https://www.510kdatabase.net/og-image/k781098-brush-applicator-fda-510k.jpg K781098 - BRUSH, APPLICATOR K781098 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Sep 1978. https://www.510kdatabase.net/k772226/ 1978-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k772226-pacemaker-model-225-227-fda-510k.jpg K772226 - PACEMAKER, MODEL 225 & 227 K772226 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Sep 1978. https://www.510kdatabase.net/k781081/ 1978-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k781081-emit-mca-program-tape-fda-510k.jpg K781081 - EMIT MCA PROGRAM TAPE K781081 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 1978. https://www.510kdatabase.net/k781427/ 1978-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k781427-ms-2-bacterial-id-system-fda-510k.jpg K781427 - MS-2 BACTERIAL ID. SYSTEM K781427 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1978. https://www.510kdatabase.net/k781472/ 1978-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k781472-mitrophenyl-alkaline-phosphates-fda-510k.jpg K781472 - MITROPHENYL, ALKALINE PHOSPHATES K781472 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Sep 1978. https://www.510kdatabase.net/k781488/ 1978-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k781488-mvs-model-seu-6-deu-6-fda-510k.jpg K781488 - MVS-MODEL SEU-6, DEU-6 K781488 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Sep 1978. https://www.510kdatabase.net/k781503/ 1978-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k781503-technicon-statlyte-ise-electrolyte-fda-510k.jpg K781503 - TECHNICON STAT/LYTE ISE ELECTROLYTE K781503 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Sep 1978. https://www.510kdatabase.net/k781577/ 1978-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k781577-disposable-cardiotomy-fda-510k.jpg K781577 - DISPOSABLE CARDIOTOMY K781577 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Sep 1978. https://www.510kdatabase.net/k781608/ 1978-09-27 monthly 0.5 https://www.510kdatabase.net/og-image/k781608-central-peg-tibial-component-fda-510k.jpg K781608 - CENTRAL PEG TIBIAL COMPONENT K781608 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Sep 1978. https://www.510kdatabase.net/k781163/ 1978-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k781163-electrode-deip-fda-510k.jpg K781163 - ELECTRODE, DEIP. K781163 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Sep 1978. https://www.510kdatabase.net/k781359/ 1978-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k781359-model-80032a-obstetrical-telemetry-fda-510k.jpg K781359 - MODEL 80032A, OBSTETRICAL TELEMETRY K781359 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Sep 1978. https://www.510kdatabase.net/k781370/ 1978-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k781370-ms-2-automated-urine-screening-system-fda-510k.jpg K781370 - MS-2 AUTOMATED URINE SCREENING SYSTEM K781370 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1978. https://www.510kdatabase.net/k781411/ 1978-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k781411-corneal-cutter-and-accessories-fda-510k.jpg K781411 - CORNEAL CUTTER AND ACCESSORIES K781411 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Sep 1978. https://www.510kdatabase.net/k781465/ 1978-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k781465-microsurgical-knives-20-30-45-fda-510k.jpg K781465 - MICROSURGICAL KNIVES, 20, 30, 45 K781465 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Sep 1978. https://www.510kdatabase.net/k781173/ 1978-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k781173-computer-interface-il-814-fda-510k.jpg K781173 - COMPUTER INTERFACE IL 814 K781173 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 1978. https://www.510kdatabase.net/k781500/ 1978-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k781500-model-845t-imagingergometer-table-fda-510k.jpg K781500 - MODEL 845T IMAGING/ERGOMETER TABLE K781500 is a FDA 510(k) cleared radiology medical device. Manufacturer: Quinton, Inc.. Cleared Sep 1978. https://www.510kdatabase.net/k781425/ 1978-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k781425-cap-mobile-fda-510k.jpg K781425 - CAP-MOBILE K781425 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Sep 1978. https://www.510kdatabase.net/k781473/ 1978-09-11 monthly 0.5 https://www.510kdatabase.net/og-image/k781473-bucky-wall-stand-fda-510k.jpg K781473 - BUCKY WALL STAND K781473 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Sep 1978. https://www.510kdatabase.net/k781360/ 1978-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k781360-model-80100a-patient-data-memory-fda-510k.jpg K781360 - MODEL 80100A, PATIENT DATA MEMORY K781360 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Sep 1978. https://www.510kdatabase.net/k781406/ 1978-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k781406-hydron-burn-bandage-manual-application-fda-510k.jpg K781406 - HYDRON BURN BANDAGE MANUAL APPLICATION K781406 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1978. https://www.510kdatabase.net/k781431/ 1978-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k781431-electric-ctt-operator-display-console-fda-510k.jpg K781431 - ELECTRIC CT/T OPERATOR DISPLAY CONSOLE K781431 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Sep 1978. https://www.510kdatabase.net/k781467/ 1978-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k781467-u-float-valve-2d9023-fda-510k.jpg K781467 - U-FLOAT VALVE 2D9023 K781467 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Sep 1978. https://www.510kdatabase.net/k781468/ 1978-09-07 monthly 0.5 https://www.510kdatabase.net/og-image/k781468-continuous-feed-valve-2d9024-fda-510k.jpg K781468 - CONTINUOUS FEED VALVE 2D9024 K781468 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Sep 1978. https://www.510kdatabase.net/k780772/ 1978-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k780772-bjork-shiley-cardiac-heart-valve-fda-510k.jpg K780772 - BJORK-SHILEY CARDIAC HEART VALVE K780772 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Sep 1978. https://www.510kdatabase.net/k780886/ 1978-09-01 monthly 0.5 https://www.510kdatabase.net/og-image/k780886-system-6000-automated-ria-analyzer-fda-510k.jpg K780886 - SYSTEM 6000 AUTOMATED RIA ANALYZER K780886 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Sep 1978. https://www.510kdatabase.net/k780952/ 1978-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k780952-model-1812-control-console-accessoriex-fda-510k.jpg K780952 - MODEL 1812 CONTROL CONSOLE, ACCESSORIEX K780952 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Aug 1978. https://www.510kdatabase.net/k780953/ 1978-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k780953-model-1861-blood-pump-fda-510k.jpg K780953 - MODEL 1861 BLOOD PUMP K780953 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Aug 1978. https://www.510kdatabase.net/k781006/ 1978-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k781006-immunochemistry-sys-manual-mode-fda-510k.jpg K781006 - IMMUNOCHEMISTRY SYS. MANUAL MODE K781006 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Aug 1978. https://www.510kdatabase.net/k781108/ 1978-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k781108-microcult-gc-culture-test-fda-510k.jpg K781108 - MICROCULT-GC CULTURE TEST K781108 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Aug 1978. https://www.510kdatabase.net/k781151/ 1978-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k781151-reprosil-fda-510k.jpg K781151 - REPROSIL K781151 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Aug 1978. https://www.510kdatabase.net/k781237/ 1978-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k781237-kidney-artificial-c-dak-20-fda-510k.jpg K781237 - KIDNEY, ARTIFICIAL, C-DAK 2.0 K781237 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Cordis Corp.. Cleared Aug 1978. https://www.510kdatabase.net/k781238/ 1978-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k781238-kidney-artificial-c-dak-15-fda-510k.jpg K781238 - KIDNEY, ARTIFICIAL, C-DAK 1.5 K781238 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Cordis Corp.. Cleared Aug 1978. https://www.510kdatabase.net/k781330/ 1978-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k781330-blood-level-detector-model-7601-fda-510k.jpg K781330 - BLOOD LEVEL DETECTOR-MODEL 7601 K781330 is a FDA 510(k) cleared radiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1978. https://www.510kdatabase.net/k781355/ 1978-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k781355-ics-normal-control-serum-fda-510k.jpg K781355 - ICS NORMAL CONTROL SERUM K781355 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Aug 1978. https://www.510kdatabase.net/k781423/ 1978-08-31 monthly 0.5 https://www.510kdatabase.net/og-image/k781423-dual-component-standards-fda-510k.jpg K781423 - DUAL COMPONENT STANDARDS K781423 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1978. https://www.510kdatabase.net/k780848/ 1978-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k780848-portable-closed-wound-suction-evacuator-fda-510k.jpg K780848 - PORTABLE CLOSED WOUND SUCTION EVACUATOR K780848 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Biomet, Inc.. Cleared Aug 1978. https://www.510kdatabase.net/k781058/ 1978-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k781058-c-dak-4000-artificial-kidney-fda-510k.jpg K781058 - C-DAK 4000 ARTIFICIAL KIDNEY K781058 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Aug 1978. https://www.510kdatabase.net/k781221/ 1978-08-23 monthly 0.5 https://www.510kdatabase.net/og-image/k781221-dilution-kit-thermal-cold-pac-fda-510k.jpg K781221 - DILUTION KIT, THERMAL, COLD PAC K781221 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Aug 1978. https://www.510kdatabase.net/k781389/ 1978-08-21 monthly 0.5 https://www.510kdatabase.net/og-image/k781389-biomet-concentric-hex-screw-fda-510k.jpg K781389 - BIOMET CONCENTRIC HEX SCREW K781389 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Aug 1978. https://www.510kdatabase.net/k781331/ 1978-08-17 monthly 0.5 https://www.510kdatabase.net/og-image/k781331-a-v-fistula-needle-fda-510k.jpg K781331 - A-V FISTULA NEEDLE K781331 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1978. https://www.510kdatabase.net/k780972/ 1978-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k780972-quickrate-reaction-rate-analyzer-fda-510k.jpg K780972 - QUICKRATE REACTION RATE ANALYZER K780972 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Aug 1978. https://www.510kdatabase.net/k781038/ 1978-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k781038-hydraulic-suction-biopsy-pump-model-7mm-fda-510k.jpg K781038 - HYDRAULIC SUCTION BIOPSY PUMP MODEL 7MM K781038 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quinton, Inc.. Cleared Aug 1978. https://www.510kdatabase.net/k781075/ 1978-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k781075-stattek-glucose-low-level-fda-510k.jpg K781075 - STATTEK-GLUCOSE LOW LEVEL K781075 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Aug 1978. https://www.510kdatabase.net/k781093/ 1978-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k781093-hdl-centrifikit-fda-510k.jpg K781093 - HDL CENTRIFIKIT K781093 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Aug 1978. https://www.510kdatabase.net/k781097/ 1978-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k781097-inoculum-stdizing-sys-inocupac-fda-510k.jpg K781097 - INOCULUM STDIZING SYS., INOCUPAC K781097 is a FDA 510(k) cleared microbiology medical device. Manufacturer: 3M Company. Cleared Aug 1978. https://www.510kdatabase.net/k781100/ 1978-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k781100-delta-test-amylaselipase-conts-iii-fda-510k.jpg K781100 - DELTA TEST AMYLASE/LIPASE CONTS. I,II K781100 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1978. https://www.510kdatabase.net/k781149/ 1978-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k781149-cpk-l-tube-fda-510k.jpg K781149 - CPK-L TUBE K781149 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1978. https://www.510kdatabase.net/k781170/ 1978-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k781170-quantimune-htsh-irma-human-thyroid-fda-510k.jpg K781170 - QUANTIMUNE HTSH IRMA HUMAN THYROID K781170 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Aug 1978. https://www.510kdatabase.net/k781180/ 1978-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k781180-cliniria-t-3-uptake-test-fda-510k.jpg K781180 - CLINIRIA T-3 UPTAKE TEST K781180 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Aug 1978. https://www.510kdatabase.net/k781181/ 1978-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k781181-cliniria-total-t-4-ria-test-fda-510k.jpg K781181 - CLINIRIA TOTAL T-4 (RIA) TEST K781181 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Aug 1978. https://www.510kdatabase.net/k781182/ 1978-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k781182-micro-thyroxine-reagent-system-fda-510k.jpg K781182 - MICRO THYROXINE REAGENT SYSTEM K781182 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1978. https://www.510kdatabase.net/k781294/ 1978-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k781294-prosthesis-knee-total-fda-510k.jpg K781294 - PROSTHESIS, KNEE, TOTAL K781294 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Aug 1978. https://www.510kdatabase.net/k781304/ 1978-08-14 monthly 0.5 https://www.510kdatabase.net/og-image/k781304-transport-media-fda-510k.jpg K781304 - TRANSPORT MEDIA K781304 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1978. https://www.510kdatabase.net/k781337/ 1978-08-11 monthly 0.5 https://www.510kdatabase.net/og-image/k781337-conjugated-bile-acids-ria-kit-fda-510k.jpg K781337 - CONJUGATED BILE ACIDS RIA KIT K781337 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1978. https://www.510kdatabase.net/k780993/ 1978-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k780993-ultrasound-imaging-system-fda-510k.jpg K780993 - ULTRASOUND IMAGING SYSTEM K780993 is a FDA 510(k) cleared radiology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Aug 1978. https://www.510kdatabase.net/k781036/ 1978-08-10 monthly 0.5 https://www.510kdatabase.net/og-image/k781036-auto-syringe-infusion-set-fda-510k.jpg K781036 - AUTO-SYRINGE INFUSION SET K781036 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Aug 1978. https://www.510kdatabase.net/k781191/ 1978-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k781191-sporks-plastic-disp-fda-510k.jpg K781191 - SPORKS, PLASTIC, DISP. K781191 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jul 1978. https://www.510kdatabase.net/k781192/ 1978-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k781192-knife-rocker-slotted-handle-fda-510k.jpg K781192 - KNIFE, ROCKER, SLOTTED HANDLE K781192 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jul 1978. https://www.510kdatabase.net/k781193/ 1978-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k781193-knife-large-handle-fda-510k.jpg K781193 - KNIFE, LARGE HANDLE K781193 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jul 1978. https://www.510kdatabase.net/k781194/ 1978-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k781194-bag-wheelchair-fda-510k.jpg K781194 - BAG, WHEELCHAIR K781194 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jul 1978. https://www.510kdatabase.net/k781195/ 1978-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k781195-bag-walder-fda-510k.jpg K781195 - BAG, WALDER K781195 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jul 1978. https://www.510kdatabase.net/k781196/ 1978-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k781196-utensils-weighted-fda-510k.jpg K781196 - UTENSILS, WEIGHTED K781196 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jul 1978. https://www.510kdatabase.net/k781197/ 1978-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k781197-stick-utility-fda-510k.jpg K781197 - STICK, UTILITY K781197 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jul 1978. https://www.510kdatabase.net/k781198/ 1978-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k781198-board-scooter-fda-510k.jpg K781198 - BOARD, SCOOTER K781198 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jul 1978. https://www.510kdatabase.net/k781199/ 1978-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k781199-holder-card-quad-quip-fda-510k.jpg K781199 - HOLDER, CARD, QUAD-QUIP K781199 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jul 1978. https://www.510kdatabase.net/k781200/ 1978-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k781200-nail-clippers-one-handed-fda-510k.jpg K781200 - NAIL CLIPPERS, ONE-HANDED K781200 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jul 1978. https://www.510kdatabase.net/k781201/ 1978-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k781201-board-transfer-fender-fda-510k.jpg K781201 - BOARD, TRANSFER, FENDER K781201 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jul 1978. https://www.510kdatabase.net/k781202/ 1978-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k781202-vest-support-trunk-fda-510k.jpg K781202 - VEST, SUPPORT, TRUNK K781202 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jul 1978. https://www.510kdatabase.net/k781203/ 1978-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k781203-tray-lap-molded-fda-510k.jpg K781203 - TRAY, LAP, MOLDED K781203 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jul 1978. https://www.510kdatabase.net/k781204/ 1978-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k781204-book-holder-fda-510k.jpg K781204 - BOOK HOLDER K781204 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jul 1978. https://www.510kdatabase.net/k781205/ 1978-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k781205-toilet-aid-fda-510k.jpg K781205 - TOILET AID K781205 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jul 1978. https://www.510kdatabase.net/k781206/ 1978-07-31 monthly 0.5 https://www.510kdatabase.net/og-image/k781206-foot-positioner-fda-510k.jpg K781206 - FOOT POSITIONER K781206 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jul 1978. https://www.510kdatabase.net/k780622/ 1978-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k780622-bipolar-endocardial-pacing-lead-m-6902-fda-510k.jpg K780622 - BIPOLAR ENDOCARDIAL PACING LEAD, M. 6902 K780622 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jul 1978. https://www.510kdatabase.net/k780623/ 1978-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k780623-endocardial-atrial-pacing-lead-m-6994-fda-510k.jpg K780623 - ENDOCARDIAL ATRIAL PACING LEAD, M. 6994 K780623 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jul 1978. https://www.510kdatabase.net/k780741/ 1978-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k780741-generator-pulse-demand-model-5996-fda-510k.jpg K780741 - GENERATOR, PULSE, DEMAND, MODEL 5996 K780741 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jul 1978. https://www.510kdatabase.net/k780809/ 1978-07-28 monthly 0.5 https://www.510kdatabase.net/og-image/k780809-generator-pulse-models-59205921-fda-510k.jpg K780809 - GENERATOR, PULSE MODELS 5920/5921 K780809 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jul 1978. https://www.510kdatabase.net/k780561/ 1978-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k780561-ventricular-inhibited-pulse-generator-fda-510k.jpg K780561 - VENTRICULAR INHIBITED PULSE GENERATOR K780561 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jul 1978. https://www.510kdatabase.net/k780766/ 1978-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k780766-125-i-digitoxin-ria-kit-fda-510k.jpg K780766 - (125 I) DIGITOXIN RIA KIT K780766 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jul 1978. https://www.510kdatabase.net/k780774/ 1978-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k780774-papillotomy-knives-fda-510k.jpg K780774 - PAPILLOTOMY KNIVES K780774 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Olympus Corp.. Cleared Jul 1978. https://www.510kdatabase.net/k780794/ 1978-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k780794-irrigation-cap-fda-510k.jpg K780794 - IRRIGATION CAP K780794 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Jul 1978. https://www.510kdatabase.net/k780859/ 1978-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k780859-princeton-biomedix-uricase-uv-fda-510k.jpg K780859 - PRINCETON BIOMEDIX URICASE (UV) K780859 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jul 1978. https://www.510kdatabase.net/k780933/ 1978-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k780933-prep-i-automated-sample-processor-fda-510k.jpg K780933 - PREP I AUTOMATED SAMPLE PROCESSOR K780933 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Jul 1978. https://www.510kdatabase.net/k780944/ 1978-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k780944-liquid-chromatograph-model-850-fda-510k.jpg K780944 - LIQUID CHROMATOGRAPH MODEL 850 K780944 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Jul 1978. https://www.510kdatabase.net/k780945/ 1978-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k780945-liquid-chromatograph-model-860-fda-510k.jpg K780945 - LIQUID CHROMATOGRAPH MODEL 860 K780945 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Jul 1978. https://www.510kdatabase.net/k780970/ 1978-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k780970-burette-set-with-air-control-lever-fda-510k.jpg K780970 - BURETTE SET WITH AIR CONTROL LEVER K780970 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Jul 1978. https://www.510kdatabase.net/k780983/ 1978-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k780983-calcium-reagent-system-no-585-fda-510k.jpg K780983 - CALCIUM REAGENT SYSTEM NO. 585 K780983 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Jul 1978. https://www.510kdatabase.net/k781045/ 1978-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k781045-a-33-dental-alloy-fda-510k.jpg K781045 - A-33 DENTAL ALLOY K781045 is a FDA 510(k) cleared dental medical device. Manufacturer: Howmedica Corp.. Cleared Jul 1978. https://www.510kdatabase.net/k781223/ 1978-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k781223-oxygenator-blood-infantpediatric-fda-510k.jpg K781223 - OXYGENATOR, BLOOD, INFANT/PEDIATRIC K781223 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Jul 1978. https://www.510kdatabase.net/k780621/ 1978-07-26 monthly 0.5 https://www.510kdatabase.net/og-image/k780621-lead-pacing-atrial-endocardial-tined-fda-510k.jpg K780621 - LEAD, PACING, ATRIAL, ENDOCARDIAL, TINED K780621 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jul 1978. https://www.510kdatabase.net/k780939/ 1978-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k780939-bard-parker-arterial-monitoring-system-fda-510k.jpg K780939 - BARD-PARKER ARTERIAL MONITORING SYSTEM K780939 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jul 1978. https://www.510kdatabase.net/k781091/ 1978-07-17 monthly 0.5 https://www.510kdatabase.net/og-image/k781091-knee-instrumentation-condylar-fda-510k.jpg K781091 - KNEE INSTRUMENTATION, CONDYLAR K781091 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Jul 1978. https://www.510kdatabase.net/k780565/ 1978-07-07 monthly 0.5 https://www.510kdatabase.net/og-image/k780565-sutureless-skin-closure-fda-510k.jpg K780565 - SUTURELESS SKIN CLOSURE K780565 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Abbott Laboratories. Cleared Jul 1978. https://www.510kdatabase.net/k780453/ 1978-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k780453-stanicor-theta-model-221-cardiac-pacer-fda-510k.jpg K780453 - STANICOR THETA MODEL 221 CARDIAC PACER K780453 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Jun 1978. https://www.510kdatabase.net/k780880/ 1978-06-30 monthly 0.5 https://www.510kdatabase.net/og-image/k780880-y-type-blood-set-fda-510k.jpg K780880 - Y-TYPE BLOOD SET K780880 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1978. https://www.510kdatabase.net/k780438/ 1978-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k780438-safety-spring-guides-teflon-coated-fda-510k.jpg K780438 - SAFETY SPRING GUIDES, TEFLON COATED K780438 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jun 1978. https://www.510kdatabase.net/k780718/ 1978-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k780718-sof-wicklap-pad-fda-510k.jpg K780718 - SOF-WICKLAP PAD K780718 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jun 1978. https://www.510kdatabase.net/k780901/ 1978-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k780901-automated-electrophoresis-system-fda-510k.jpg K780901 - AUTOMATED ELECTROPHORESIS SYSTEM K780901 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Olympus Corp.. Cleared Jun 1978. https://www.510kdatabase.net/k781005/ 1978-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k781005-electroencephalograph-accutrate-200-fda-510k.jpg K781005 - ELECTROENCEPHALOGRAPH ACCUTRATE 200 K781005 is a FDA 510(k) cleared neurology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jun 1978. https://www.510kdatabase.net/k781041/ 1978-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k781041-electroencephalograph-accutrace-100-fda-510k.jpg K781041 - ELECTROENCEPHALOGRAPH ACCUTRACE 100 K781041 is a FDA 510(k) cleared neurology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jun 1978. https://www.510kdatabase.net/k780695/ 1978-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k780695-auto-suture-disposable-stapling-instru-fda-510k.jpg K780695 - AUTO SUTURE DISPOSABLE STAPLING INSTRU. K780695 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Jun 1978. https://www.510kdatabase.net/k780773/ 1978-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k780773-prosthesis-hip-cathcart-schiller-mod-fda-510k.jpg K780773 - PROSTHESIS, HIP, CATHCART, SCHILLER MOD. K780773 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jun 1978. https://www.510kdatabase.net/k780788/ 1978-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k780788-irrigation-catheter-fda-510k.jpg K780788 - IRRIGATION CATHETER K780788 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Shiley, Inc.. Cleared Jun 1978. https://www.510kdatabase.net/k780858/ 1978-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k780858-princeton-biomedix-hexokinase-glucose-fda-510k.jpg K780858 - PRINCETON BIOMEDIX HEXOKINASE, GLUCOSE K780858 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jun 1978. https://www.510kdatabase.net/k780881/ 1978-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k780881-emit-clinical-processor-cp-5000-fda-510k.jpg K780881 - EMIT CLINICAL PROCESSOR - CP 5000 K780881 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Jun 1978. https://www.510kdatabase.net/k780904/ 1978-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k780904-knee-total-femoral-tibial-fda-510k.jpg K780904 - KNEE, TOTAL, FEMORAL & TIBIAL K780904 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jun 1978. https://www.510kdatabase.net/k780913/ 1978-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k780913-additional-reagents-kits-for-imm-system-fda-510k.jpg K780913 - ADDITIONAL REAGENTS KITS FOR IMM. SYSTEM K780913 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jun 1978. https://www.510kdatabase.net/k780924/ 1978-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k780924-electrosurgical-grounding-pad-cable-fda-510k.jpg K780924 - ELECTROSURGICAL GROUNDING PAD CABLE K780924 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jun 1978. https://www.510kdatabase.net/k780393/ 1978-06-19 monthly 0.5 https://www.510kdatabase.net/og-image/k780393-biostator-glucose-analyzer-fda-510k.jpg K780393 - BIOSTATOR GLUCOSE ANALYZER K780393 is a FDA 510(k) cleared hematology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Jun 1978. https://www.510kdatabase.net/k780289/ 1978-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k780289-nerve-approximater-fda-510k.jpg K780289 - NERVE APPROXIMATER K780289 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Jun 1978. https://www.510kdatabase.net/k780354/ 1978-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k780354-cryocyte-pack-fda-510k.jpg K780354 - CRYOCYTE PACK K780354 is a FDA 510(k) cleared hematology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Jun 1978. https://www.510kdatabase.net/k780716/ 1978-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k780716-technicon-bgii-analyzer-fda-510k.jpg K780716 - TECHNICON BGII ANALYZER K780716 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Jun 1978. https://www.510kdatabase.net/k780782/ 1978-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k780782-m-1336s-cathode-ray-tube-display-fda-510k.jpg K780782 - M. 1336S CATHODE-RAY TUBE DISPLAY K780782 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Jun 1978. https://www.510kdatabase.net/k780786/ 1978-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k780786-denture-reline-material-fda-510k.jpg K780786 - DENTURE RELINE MATERIAL K780786 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jun 1978. https://www.510kdatabase.net/k780668/ 1978-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k780668-solutions-for-respiratory-therapy-fda-510k.jpg K780668 - SOLUTIONS FOR RESPIRATORY THERAPY K780668 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Jun 1978. https://www.510kdatabase.net/k780847/ 1978-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k780847-ninhydrin-reagent-kit-fda-510k.jpg K780847 - NINHYDRIN REAGENT KIT K780847 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jun 1978. https://www.510kdatabase.net/k780857/ 1978-06-13 monthly 0.5 https://www.510kdatabase.net/og-image/k780857-mixing-bowl-spatula-disposable-fda-510k.jpg K780857 - MIXING BOWL & SPATULA, DISPOSABLE K780857 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jun 1978. https://www.510kdatabase.net/k780554/ 1978-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k780554-clin-chem-control-serum-quantitate-fda-510k.jpg K780554 - CLIN. CHEM. CONTROL SERUM-QUANTITATE K780554 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jun 1978. https://www.510kdatabase.net/k780787/ 1978-06-06 monthly 0.5 https://www.510kdatabase.net/og-image/k780787-triiodothyronine-radioimmunoassay-kit-fda-510k.jpg K780787 - TRIIODOTHYRONINE RADIOIMMUNOASSAY KIT K780787 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jun 1978. https://www.510kdatabase.net/k780807/ 1978-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k780807-hbf-quiplate-methodology-fda-510k.jpg K780807 - HBF-QUIPLATE METHODOLOGY K780807 is a FDA 510(k) cleared hematology medical device. Manufacturer: Helena Laboratories. Cleared Jun 1978. https://www.510kdatabase.net/k780630/ 1978-05-31 monthly 0.5 https://www.510kdatabase.net/og-image/k780630-controller-servo-inspiron-fda-510k.jpg K780630 - CONTROLLER, SERVO, INSPIRON K780630 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 1978. https://www.510kdatabase.net/k780711/ 1978-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k780711-micro-ring-fda-510k.jpg K780711 - MICRO-RING K780711 is a FDA 510(k) cleared dental medical device. Manufacturer: Howmedica Corp.. Cleared May 1978. https://www.510kdatabase.net/k780762/ 1978-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k780762-embolectomy-catheter-extend-shelf-life-fda-510k.jpg K780762 - EMBOLECTOMY CATHETER, EXTEND. SHELF LIFE K780762 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared May 1978. https://www.510kdatabase.net/k780768/ 1978-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k780768-model-5621a-interface-fda-510k.jpg K780768 - MODEL 5621A INTERFACE K780768 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared May 1978. https://www.510kdatabase.net/k780446/ 1978-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k780446-sutureless-myocardial-pacing-lead-fda-510k.jpg K780446 - SUTURELESS MYOCARDIAL PACING LEAD K780446 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared May 1978. https://www.510kdatabase.net/k780552/ 1978-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k780552-comp-clin-chem-control-serum-decision-fda-510k.jpg K780552 - COMP. CLIN. CHEM. CONTROL SERUM-DECISION K780552 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared May 1978. https://www.510kdatabase.net/k780553/ 1978-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k780553-comp-clin-chem-ref-serum-benchmark-fda-510k.jpg K780553 - COMP. CLIN. CHEM. REF. SERUM-BENCHMARK K780553 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared May 1978. https://www.510kdatabase.net/k780579/ 1978-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k780579-subcupass-tunneling-tool-fda-510k.jpg K780579 - SUBCUPASS TUNNELING TOOL K780579 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared May 1978. https://www.510kdatabase.net/k780635/ 1978-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k780635-reagent-set-hdl-cholesterol-fda-510k.jpg K780635 - REAGENT SET HDL CHOLESTEROL K780635 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared May 1978. https://www.510kdatabase.net/k780758/ 1978-05-19 monthly 0.5 https://www.510kdatabase.net/og-image/k780758-neurological-screening-stimulator-m-3623-fda-510k.jpg K780758 - NEUROLOGICAL SCREENING STIMULATOR M 3623 K780758 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared May 1978. https://www.510kdatabase.net/k780327/ 1978-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k780327-generators-atrial-inhibited-pulse-fda-510k.jpg K780327 - GENERATORS, ATRIAL INHIBITED PULSE K780327 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared May 1978. https://www.510kdatabase.net/k780557/ 1978-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k780557-folate-reagent-kit-aria-ii-system-fda-510k.jpg K780557 - FOLATE REAGENT KIT, ARIA-II SYSTEM K780557 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared May 1978. https://www.510kdatabase.net/k780634/ 1978-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k780634-single-vial-10-sgot-tris-fda-510k.jpg K780634 - SINGLE VIAL 10 SGOT-TRIS K780634 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared May 1978. https://www.510kdatabase.net/k780636/ 1978-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k780636-single-vial-10-sgpt-tris-fda-510k.jpg K780636 - SINGLE VIAL 10 SGPT-TRIS K780636 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared May 1978. https://www.510kdatabase.net/k780381/ 1978-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k780381-respiratory-therapy-solutions-flexible-fda-510k.jpg K780381 - RESPIRATORY THERAPY SOLUTIONS - FLEXIBLE K780381 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared May 1978. https://www.510kdatabase.net/k780385/ 1978-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k780385-respiratory-therapy-solutions-flexible-fda-510k.jpg K780385 - RESPIRATORY THERAPY SOLUTIONS - FLEXIBLE K780385 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared May 1978. https://www.510kdatabase.net/k780449/ 1978-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k780449-beta-cap-system-fda-510k.jpg K780449 - BETA CAP SYSTEM K780449 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quinton, Inc.. Cleared May 1978. https://www.510kdatabase.net/k780520/ 1978-05-16 monthly 0.5 https://www.510kdatabase.net/og-image/k780520-vas-approximator-fda-510k.jpg K780520 - VAS APPROXIMATOR K780520 is a FDA 510(k) cleared neurology medical device. Manufacturer: Edward Weck, Inc.. Cleared May 1978. https://www.510kdatabase.net/k780330/ 1978-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k780330-total-hip-lord-madreporic-fda-510k.jpg K780330 - TOTAL HIP, LORD MADREPORIC K780330 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared May 1978. https://www.510kdatabase.net/k780521/ 1978-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k780521-spectrophotometer-atomic-absorption-fda-510k.jpg K780521 - SPECTROPHOTOMETER, ATOMIC ABSORPTION K780521 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared May 1978. https://www.510kdatabase.net/k780522/ 1978-05-12 monthly 0.5 https://www.510kdatabase.net/og-image/k780522-spectrophotometers-atomic-absorption-fda-510k.jpg K780522 - SPECTROPHOTOMETERS, ATOMIC ABSORPTION K780522 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared May 1978. https://www.510kdatabase.net/k772393/ 1978-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k772393-carroll-tendon-retriever-fda-510k.jpg K772393 - CARROLL TENDON RETRIEVER K772393 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared May 1978. https://www.510kdatabase.net/k780675/ 1978-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k780675-sterile-100-silicone-foley-catheter-fda-510k.jpg K780675 - STERILE 100% SILICONE FOLEY CATHETER K780675 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medline Industries, Inc.. Cleared May 1978. https://www.510kdatabase.net/k780676/ 1978-05-09 monthly 0.5 https://www.510kdatabase.net/og-image/k780676-sterile-closed-system-fda-510k.jpg K780676 - STERILE CLOSED SYSTEM K780676 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medline Industries, Inc.. Cleared May 1978. https://www.510kdatabase.net/k780214/ 1978-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k780214-hemo-fec-fda-510k.jpg K780214 - HEMO FEC K780214 is a FDA 510(k) cleared hematology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared May 1978. https://www.510kdatabase.net/k780372/ 1978-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k780372-cre-phosphokinase-isoenzymes-rea-sys-fda-510k.jpg K780372 - CRE. PHOSPHOKINASE ISOENZYMES, REA. SYS. K780372 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared May 1978. https://www.510kdatabase.net/k780639/ 1978-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k780639-emit-centrifichem-thyroxine-assay-fda-510k.jpg K780639 - EMIT CENTRIFICHEM THYROXINE ASSAY K780639 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared May 1978. https://www.510kdatabase.net/k780373/ 1978-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k780373-stac-system-fda-510k.jpg K780373 - STAC SYSTEM K780373 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Apr 1978. https://www.510kdatabase.net/k780530/ 1978-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k780530-automated-physiologic-profiler-fda-510k.jpg K780530 - AUTOMATED PHYSIOLOGIC PROFILER K780530 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1978. https://www.510kdatabase.net/k780567/ 1978-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k780567-aortic-pump-fda-510k.jpg K780567 - AORTIC PUMP K780567 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Ethicon, Inc.. Cleared Apr 1978. https://www.510kdatabase.net/k780409/ 1978-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k780409-coloplast-duraseal-ostomy-appliance-fda-510k.jpg K780409 - COLOPLAST-DURASEAL OSTOMY APPLIANCE K780409 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 1978. https://www.510kdatabase.net/k780643/ 1978-04-27 monthly 0.5 https://www.510kdatabase.net/og-image/k780643-shadow-caths-fda-510k.jpg K780643 - SHADOW-CATHS K780643 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quinton, Inc.. Cleared Apr 1978. https://www.510kdatabase.net/k780097/ 1978-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k780097-quality-control-system-spectra-fda-510k.jpg K780097 - QUALITY CONTROL SYSTEM, SPECTRA K780097 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1978. https://www.510kdatabase.net/k780466/ 1978-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k780466-emit-carbamazepine-assay-fda-510k.jpg K780466 - EMIT CARBAMAZEPINE ASSAY K780466 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Apr 1978. https://www.510kdatabase.net/k780467/ 1978-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k780467-emit-antiepileptic-drug-calibrators-fda-510k.jpg K780467 - EMIT ANTIEPILEPTIC DRUG CALIBRATORS K780467 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Apr 1978. https://www.510kdatabase.net/k780556/ 1978-04-24 monthly 0.5 https://www.510kdatabase.net/og-image/k780556-spect-rim-liss-fda-510k.jpg K780556 - SPECT RIM (LISS) K780556 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1978. https://www.510kdatabase.net/k780175/ 1978-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k780175-rate-programmer-model-520-fda-510k.jpg K780175 - RATE PROGRAMMER MODEL 520 K780175 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Apr 1978. https://www.510kdatabase.net/k780302/ 1978-04-21 monthly 0.5 https://www.510kdatabase.net/og-image/k780302-blood-flowmeter-system-fda-510k.jpg K780302 - BLOOD FLOWMETER SYSTEM K780302 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Apr 1978. https://www.510kdatabase.net/k780616/ 1978-04-19 monthly 0.5 https://www.510kdatabase.net/og-image/k780616-hydron-burn-disposable-dispenser-set-fda-510k.jpg K780616 - HYDRON BURN DISPOSABLE DISPENSER SET K780616 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1978. https://www.510kdatabase.net/k780355/ 1978-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k780355-atroxin-fda-510k.jpg K780355 - ATROXIN K780355 is a FDA 510(k) cleared hematology medical device. Manufacturer: Sigma Chemical Co.. Cleared Apr 1978. https://www.510kdatabase.net/k780439/ 1978-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k780439-precimat-glycerol-fda-510k.jpg K780439 - PRECIMAT GLYCEROL K780439 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Apr 1978. https://www.510kdatabase.net/k780480/ 1978-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k780480-ctt-independent-diagnostic-center-fda-510k.jpg K780480 - CT/T INDEPENDENT DIAGNOSTIC CENTER K780480 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Apr 1978. https://www.510kdatabase.net/k780491/ 1978-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k780491-data-camera-fda-510k.jpg K780491 - DATA CAMERA K780491 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Apr 1978. https://www.510kdatabase.net/k780563/ 1978-04-18 monthly 0.5 https://www.510kdatabase.net/og-image/k780563-single-vial-lactate-fda-510k.jpg K780563 - SINGLE VIAL LACTATE K780563 is a FDA 510(k) cleared hematology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Apr 1978. https://www.510kdatabase.net/k780386/ 1978-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k780386-k-y-lubricating-jelly-fda-510k.jpg K780386 - K-Y LUBRICATING JELLY K780386 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Apr 1978. https://www.510kdatabase.net/k780517/ 1978-04-13 monthly 0.5 https://www.510kdatabase.net/og-image/k780517-cardiotomy-reservoir-fda-510k.jpg K780517 - CARDIOTOMY RESERVOIR K780517 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Apr 1978. https://www.510kdatabase.net/k780380/ 1978-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k780380-analyzer-fast-centrifugal-gemsaec-fda-510k.jpg K780380 - ANALYZER, FAST, CENTRIFUGAL, GEMSAEC K780380 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Apr 1978. https://www.510kdatabase.net/k780406/ 1978-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k780406-2c7153-nebulizer-cap-fda-510k.jpg K780406 - 2C7153 NEBULIZER CAP K780406 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Apr 1978. https://www.510kdatabase.net/k780441/ 1978-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k780441-theophylline-assay-to-the-centrifichem-fda-510k.jpg K780441 - THEOPHYLLINE ASSAY TO THE CENTRIFICHEM K780441 is a FDA 510(k) cleared immunology medical device. Manufacturer: Syva Co.. Cleared Apr 1978. https://www.510kdatabase.net/k780442/ 1978-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k780442-theophylline-assay-to-the-gemsaec-fda-510k.jpg K780442 - THEOPHYLLINE ASSAY TO THE GEMSAEC K780442 is a FDA 510(k) cleared immunology medical device. Manufacturer: Syva Co.. Cleared Apr 1978. https://www.510kdatabase.net/k780456/ 1978-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k780456-nebulizer-heater-fda-510k.jpg K780456 - NEBULIZER HEATER K780456 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Apr 1978. https://www.510kdatabase.net/k780461/ 1978-04-12 monthly 0.5 https://www.510kdatabase.net/og-image/k780461-analyzer-supplement-kinetic-lkb-2086-fda-510k.jpg K780461 - ANALYZER-SUPPLEMENT, KINETIC, LKB 2086 K780461 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Apr 1978. https://www.510kdatabase.net/k780220/ 1978-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k780220-hood-infant-oxygen-fda-510k.jpg K780220 - HOOD, INFANT OXYGEN K780220 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shiley, Inc.. Cleared Apr 1978. https://www.510kdatabase.net/k780223/ 1978-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k780223-parenteral-infusion-controller-fda-510k.jpg K780223 - PARENTERAL INFUSION CONTROLLER K780223 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Apr 1978. https://www.510kdatabase.net/k780407/ 1978-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k780407-2c7125-blow-bottle-fda-510k.jpg K780407 - 2C7125 BLOW BOTTLE K780407 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Apr 1978. https://www.510kdatabase.net/k780481/ 1978-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k780481-iv-lever-clamp-fda-510k.jpg K780481 - I.V. LEVER CLAMP K780481 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Apr 1978. https://www.510kdatabase.net/k780494/ 1978-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k780494-amikacin-fda-510k.jpg K780494 - AMIKACIN K780494 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Apr 1978. https://www.510kdatabase.net/k780495/ 1978-04-10 monthly 0.5 https://www.510kdatabase.net/og-image/k780495-digitoxin-fda-510k.jpg K780495 - DIGITOXIN K780495 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Apr 1978. https://www.510kdatabase.net/k772387/ 1978-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k772387-lead-hand-fda-510k.jpg K772387 - LEAD HAND K772387 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Edward Weck, Inc.. Cleared Apr 1978. https://www.510kdatabase.net/k780295/ 1978-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k780295-calibrators-carbon-dioxide-fda-510k.jpg K780295 - CALIBRATORS, CARBON DIOXIDE K780295 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Apr 1978. https://www.510kdatabase.net/k780357/ 1978-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k780357-titanium-muller-total-hip-fda-510k.jpg K780357 - TITANIUM MULLER TOTAL HIP K780357 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Apr 1978. https://www.510kdatabase.net/k780437/ 1978-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k780437-pacemaker-model-252-c-mos-fda-510k.jpg K780437 - PACEMAKER, MODEL 252, C-MOS K780437 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Apr 1978. https://www.510kdatabase.net/k780119/ 1978-04-03 monthly 0.5 https://www.510kdatabase.net/og-image/k780119-nebulizer-disp-2d0815-fda-510k.jpg K780119 - NEBULIZER, DISP, 2D0815 K780119 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Apr 1978. https://www.510kdatabase.net/k780081/ 1978-03-31 monthly 0.5 https://www.510kdatabase.net/og-image/k780081-dialyzing-fluide-delivery-system-fda-510k.jpg K780081 - DIALYZING FLUIDE DELIVERY SYSTEM K780081 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Mar 1978. https://www.510kdatabase.net/k780189/ 1978-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k780189-platelet-rotator-fda-510k.jpg K780189 - PLATELET ROTATOR K780189 is a FDA 510(k) cleared hematology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Mar 1978. https://www.510kdatabase.net/k780303/ 1978-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k780303-auto-iso-filter-collection-tube-cap-fda-510k.jpg K780303 - AUTO ISO-FILTER COLLECTION TUBE CAP K780303 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1978. https://www.510kdatabase.net/k780253/ 1978-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k780253-reagent-system-aria-ii-t3-uptake-fda-510k.jpg K780253 - REAGENT SYSTEM, ARIA II T3 UPTAKE K780253 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1978. https://www.510kdatabase.net/k780256/ 1978-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k780256-hdl-cholesterol-method-fda-510k.jpg K780256 - HDL CHOLESTEROL METHOD K780256 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Helena Laboratories. Cleared Mar 1978. https://www.510kdatabase.net/k780404/ 1978-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k780404-ecg-monitoring-system-fda-510k.jpg K780404 - ECG MONITORING SYSTEM, K780404 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Mar 1978. https://www.510kdatabase.net/k780163/ 1978-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k780163-redi-disc-hemoglobin-gel-tube-kit-fda-510k.jpg K780163 - REDI-DISC HEMOGLOBIN GEL TUBE KIT K780163 is a FDA 510(k) cleared hematology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Mar 1978. https://www.510kdatabase.net/k780350/ 1978-03-27 monthly 0.5 https://www.510kdatabase.net/og-image/k780350-iv-start-kit-fda-510k.jpg K780350 - I.V. START KIT K780350 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1978. https://www.510kdatabase.net/k780332/ 1978-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k780332-cathode-ray-tube-display-model-1340a-fda-510k.jpg K780332 - CATHODE RAY TUBE DISPLAY MODEL 1340A K780332 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Mar 1978. https://www.510kdatabase.net/k780388/ 1978-03-22 monthly 0.5 https://www.510kdatabase.net/og-image/k780388-analyzer-100-bichromatic-abbott-fda-510k.jpg K780388 - ANALYZER, 100, BICHROMATIC, ABBOTT K780388 is a FDA 510(k) cleared immunology medical device. Manufacturer: Syva Co.. Cleared Mar 1978. https://www.510kdatabase.net/k780158/ 1978-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k780158-teletrace-telephone-ekg-transmitter-fda-510k.jpg K780158 - TELETRACE TELEPHONE EKG TRANSMITTER K780158 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Mar 1978. https://www.510kdatabase.net/k780121/ 1978-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k780121-reagents-manueal-assay-thyroxine-fda-510k.jpg K780121 - REAGENTS, MANUEAL, ASSAY, THYROXINE K780121 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Mar 1978. https://www.510kdatabase.net/k780154/ 1978-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k780154-needleholder-microvasular-5-12-fda-510k.jpg K780154 - NEEDLEHOLDER, MICROVASULAR 5 1/2 K780154 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Edward Weck, Inc.. Cleared Mar 1978. https://www.510kdatabase.net/k780283/ 1978-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k780283-inserter-plug-bone-lidge-fda-510k.jpg K780283 - INSERTER, PLUG, BONE, LIDGE K780283 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Mar 1978. https://www.510kdatabase.net/k780329/ 1978-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k780329-total-hip-new-england-baptist-fda-510k.jpg K780329 - TOTAL HIP, NEW ENGLAND BAPTIST K780329 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Mar 1978. https://www.510kdatabase.net/k780187/ 1978-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k780187-nail-massie-ii-fda-510k.jpg K780187 - NAIL, MASSIE II K780187 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Mar 1978. https://www.510kdatabase.net/k780217/ 1978-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k780217-anteriors-and-posteriors-plastic-fda-510k.jpg K780217 - ANTERIORS AND POSTERIORS, PLASTIC K780217 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Mar 1978. https://www.510kdatabase.net/k780227/ 1978-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k780227-bandage-spreader-block-fda-510k.jpg K780227 - BANDAGE SPREADER BLOCK K780227 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Biomet, Inc.. Cleared Mar 1978. https://www.510kdatabase.net/k780280/ 1978-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k780280-balloon-pump-fda-510k.jpg K780280 - BALLOON PUMP K780280 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Mar 1978. https://www.510kdatabase.net/k780284/ 1978-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k780284-tibial-plateu-fda-510k.jpg K780284 - TIBIAL PLATEU K780284 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Mar 1978. https://www.510kdatabase.net/k780375/ 1978-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k780375-pavlik-harness-fda-510k.jpg K780375 - PAVLIK HARNESS K780375 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Biomet, Inc.. Cleared Mar 1978. https://www.510kdatabase.net/k780260/ 1978-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k780260-temp-sensor-w22mm-fittings-fda-510k.jpg K780260 - TEMP. SENSOR W/22MM FITTINGS K780260 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1978. https://www.510kdatabase.net/k780313/ 1978-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k780313-hitachi-tech-moble-dhc-121-fda-510k.jpg K780313 - HITACHI TECH-MOBLE DHC-121 K780313 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Mar 1978. https://www.510kdatabase.net/k780319/ 1978-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k780319-orbitome-ug-fda-510k.jpg K780319 - ORBITOME-UG K780319 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Mar 1978. https://www.510kdatabase.net/k780324/ 1978-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k780324-capnometer-model-47210a-fda-510k.jpg K780324 - CAPNOMETER MODEL 47210A K780324 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Mar 1978. https://www.510kdatabase.net/k780326/ 1978-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k780326-ge-ctt-8800-system-fda-510k.jpg K780326 - GE CT/T 8800 SYSTEM K780326 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Mar 1978. https://www.510kdatabase.net/k780349/ 1978-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k780349-vaginal-retractor-fda-510k.jpg K780349 - VAGINAL RETRACTOR K780349 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Edward Weck, Inc.. Cleared Mar 1978. https://www.510kdatabase.net/k780368/ 1978-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k780368-modumed-mugx-fda-510k.jpg K780368 - MODUMED MUGX K780368 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medtronic Vascular. Cleared Mar 1978. https://www.510kdatabase.net/k780369/ 1978-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k780369-modumed-muge-fda-510k.jpg K780369 - MODUMED MUGE K780369 is a FDA 510(k) cleared radiology medical device. Manufacturer: Medtronic Vascular. Cleared Mar 1978. https://www.510kdatabase.net/k772350/ 1978-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k772350-patient-alert-model-555-fda-510k.jpg K772350 - PATIENT ALERT MODEL 555 K772350 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Mar 1978. https://www.510kdatabase.net/k772373/ 1978-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k772373-anderson-neivert-osteotome-fda-510k.jpg K772373 - ANDERSON-NEIVERT OSTEOTOME K772373 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Mar 1978. https://www.510kdatabase.net/k772374/ 1978-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k772374-silver-osteotome-fda-510k.jpg K772374 - SILVER OSTEOTOME K772374 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Mar 1978. https://www.510kdatabase.net/k772376/ 1978-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k772376-neivert-osteotome-fda-510k.jpg K772376 - NEIVERT OSTEOTOME K772376 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Mar 1978. https://www.510kdatabase.net/k772378/ 1978-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k772378-neivs-tracheotomy-retractor-fda-510k.jpg K772378 - NEIVS TRACHEOTOMY RETRACTOR K772378 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Mar 1978. https://www.510kdatabase.net/k772383/ 1978-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k772383-long-jewelers-forceps-fda-510k.jpg K772383 - LONG JEWELERS FORCEPS K772383 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Mar 1978. https://www.510kdatabase.net/k772394/ 1978-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k772394-kalrn-face-life-scissors-fda-510k.jpg K772394 - KALRN FACE-LIFE SCISSORS K772394 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Mar 1978. https://www.510kdatabase.net/k772395/ 1978-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k772395-davis-rhytidectomy-fda-510k.jpg K772395 - DAVIS RHYTIDECTOMY K772395 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Mar 1978. https://www.510kdatabase.net/k780317/ 1978-03-06 monthly 0.5 https://www.510kdatabase.net/og-image/k780317-total-hip-system-harris-hd2-fda-510k.jpg K780317 - TOTAL HIP SYSTEM, HARRIS HD2 K780317 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Mar 1978. https://www.510kdatabase.net/k780218/ 1978-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k780218-analyzer-emit-aed-assays-to-centrifiche-fda-510k.jpg K780218 - ANALYZER, EMIT AED ASSAYS TO CENTRIFICHE K780218 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Mar 1978. https://www.510kdatabase.net/k780219/ 1978-03-03 monthly 0.5 https://www.510kdatabase.net/og-image/k780219-analysis-sys-emit-man-thyroxine-assay-fda-510k.jpg K780219 - ANALYSIS SYS., EMIT MAN. THYROXINE ASSAY K780219 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Mar 1978. https://www.510kdatabase.net/k780176/ 1978-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k780176-display-system-model-428-fda-510k.jpg K780176 - DISPLAY SYSTEM MODEL 428 K780176 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Mar 1978. https://www.510kdatabase.net/k780177/ 1978-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k780177-fetal-monitor-model-112-fda-510k.jpg K780177 - FETAL MONITOR MODEL 112 K780177 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Ge Medical Systems Information Technologies. Cleared Mar 1978. https://www.510kdatabase.net/k780186/ 1978-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k780186-neuromod-stimulator-model-3723-fda-510k.jpg K780186 - NEUROMOD STIMULATOR MODEL 3723 K780186 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Mar 1978. https://www.510kdatabase.net/k780229/ 1978-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k780229-abdominal-belt-fda-510k.jpg K780229 - ABDOMINAL BELT K780229 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Biomet, Inc.. Cleared Mar 1978. https://www.510kdatabase.net/k780248/ 1978-03-02 monthly 0.5 https://www.510kdatabase.net/og-image/k780248-cronex-qc-1-processor-fda-510k.jpg K780248 - CRONEX QC-1 PROCESSOR K780248 is a FDA 510(k) cleared radiology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Mar 1978. https://www.510kdatabase.net/k780075/ 1978-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k780075-rialyze-digoxin-fda-510k.jpg K780075 - RIALYZE DIGOXIN K780075 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Feb 1978. https://www.510kdatabase.net/k780230/ 1978-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k780230-bed-board-fda-510k.jpg K780230 - BED BOARD K780230 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Biomet, Inc.. Cleared Feb 1978. https://www.510kdatabase.net/k780266/ 1978-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k780266-bone-cement-applicator-fda-510k.jpg K780266 - BONE CEMENT APPLICATOR K780266 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared Feb 1978. https://www.510kdatabase.net/k780286/ 1978-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k780286-brachial-large-vessel-approximator-fda-510k.jpg K780286 - BRACHIAL-LARGE VESSEL APPROXIMATOR K780286 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Feb 1978. https://www.510kdatabase.net/k780288/ 1978-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k780288-bracheal-large-vessel-clip-fda-510k.jpg K780288 - BRACHEAL-LARGE VESSEL CLIP K780288 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Feb 1978. https://www.510kdatabase.net/k780290/ 1978-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k780290-ulnar-radial-clip-fda-510k.jpg K780290 - ULNAR-RADIAL CLIP K780290 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Feb 1978. https://www.510kdatabase.net/k780291/ 1978-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k780291-ulnar-radial-approximater-fda-510k.jpg K780291 - ULNAR-RADIAL APPROXIMATER K780291 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Feb 1978. https://www.510kdatabase.net/k780298/ 1978-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k780298-electro-surgical-grounding-pad-fda-510k.jpg K780298 - ELECTRO-SURGICAL GROUNDING PAD K780298 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Feb 1978. https://www.510kdatabase.net/k780287/ 1978-02-27 monthly 0.5 https://www.510kdatabase.net/og-image/k780287-day-hear-hook-fda-510k.jpg K780287 - DAY HEAR HOOK K780287 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Edward Weck, Inc.. Cleared Feb 1978. https://www.510kdatabase.net/k780225/ 1978-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k780225-orthosises-devices-fda-510k.jpg K780225 - ORTHOSISES DEVICES K780225 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Biomet, Inc.. Cleared Feb 1978. https://www.510kdatabase.net/k780228/ 1978-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k780228-traction-units-fda-510k.jpg K780228 - TRACTION UNITS K780228 is a FDA 510(k) cleared neurology medical device. Manufacturer: Biomet, Inc.. Cleared Feb 1978. https://www.510kdatabase.net/k780233/ 1978-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k780233-traction-weight-bags-fda-510k.jpg K780233 - TRACTION WEIGHT BAGS K780233 is a FDA 510(k) cleared neurology medical device. Manufacturer: Biomet, Inc.. Cleared Feb 1978. https://www.510kdatabase.net/k780234/ 1978-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k780234-traction-belt-pelvic-fda-510k.jpg K780234 - TRACTION BELT, PELVIC K780234 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Biomet, Inc.. Cleared Feb 1978. https://www.510kdatabase.net/k780235/ 1978-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k780235-orthopedic-devices-fda-510k.jpg K780235 - ORTHOPEDIC DEVICES K780235 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Biomet, Inc.. Cleared Feb 1978. https://www.510kdatabase.net/k772403/ 1978-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k772403-cut-down-built-up-toilet-seat-fda-510k.jpg K772403 - CUT-DOWN BUILT-UP TOILET SEAT K772403 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Fred Sammons, Inc.. Cleared Feb 1978. https://www.510kdatabase.net/k780057/ 1978-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k780057-urine-sample-collection-kit-fda-510k.jpg K780057 - URINE SAMPLE COLLECTION KIT K780057 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Feb 1978. https://www.510kdatabase.net/k780105/ 1978-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k780105-needle-connecting-set-blunt-fda-510k.jpg K780105 - NEEDLE CONNECTING SET, BLUNT K780105 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Feb 1978. https://www.510kdatabase.net/k780166/ 1978-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k780166-stress-test-system-fda-510k.jpg K780166 - STRESS TEST SYSTEM K780166 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Feb 1978. https://www.510kdatabase.net/k780167/ 1978-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k780167-cath-kit-urine-specimen-fda-510k.jpg K780167 - CATH KIT, URINE SPECIMEN K780167 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Feb 1978. https://www.510kdatabase.net/k780231/ 1978-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k780231-bandage-elastic-fda-510k.jpg K780231 - BANDAGE, ELASTIC K780231 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Biomet, Inc.. Cleared Feb 1978. https://www.510kdatabase.net/k780232/ 1978-02-21 monthly 0.5 https://www.510kdatabase.net/og-image/k780232-restraint-protective-fda-510k.jpg K780232 - RESTRAINT, PROTECTIVE K780232 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Biomet, Inc.. Cleared Feb 1978. https://www.510kdatabase.net/k780226/ 1978-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k780226-spreader-bars-fda-510k.jpg K780226 - SPREADER BARS K780226 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Biomet, Inc.. Cleared Feb 1978. https://www.510kdatabase.net/k772404/ 1978-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k772404-finger-exercise-board-fda-510k.jpg K772404 - FINGER EXERCISE BOARD K772404 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Feb 1978. https://www.510kdatabase.net/k772422/ 1978-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k772422-quantimune-digoxin-riadigoxin-ria-fda-510k.jpg K772422 - QUANTIMUNE DIGOXIN RIA/DIGOXIN RIA K772422 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Feb 1978. https://www.510kdatabase.net/k780043/ 1978-02-13 monthly 0.5 https://www.510kdatabase.net/og-image/k780043-esis-module-fda-510k.jpg K780043 - ESIS MODULE K780043 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Feb 1978. https://www.510kdatabase.net/k780122/ 1978-02-03 monthly 0.5 https://www.510kdatabase.net/og-image/k780122-htsh-ria-fda-510k.jpg K780122 - HTSH RIA K780122 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Feb 1978. https://www.510kdatabase.net/k772186/ 1978-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k772186-electrocardiograph-transmitter-536-fda-510k.jpg K772186 - ELECTROCARDIOGRAPH TRANSMITTER, 536 K772186 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Feb 1978. https://www.510kdatabase.net/k772379/ 1978-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k772379-joseph-saw-fda-510k.jpg K772379 - JOSEPH SAW K772379 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Edward Weck, Inc.. Cleared Feb 1978. https://www.510kdatabase.net/k780088/ 1978-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k780088-hymidifier-fda-510k.jpg K780088 - HYMIDIFIER K780088 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: 3M Company. Cleared Feb 1978. https://www.510kdatabase.net/k780152/ 1978-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k780152-facelift-scissors-fda-510k.jpg K780152 - FACELIFT SCISSORS K780152 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Feb 1978. https://www.510kdatabase.net/k780153/ 1978-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k780153-house-suction-irrigator-fda-510k.jpg K780153 - HOUSE SUCTION IRRIGATOR K780153 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Feb 1978. https://www.510kdatabase.net/k772414/ 1978-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k772414-sandbags-various-weights-fda-510k.jpg K772414 - SANDBAGS, VARIOUS WEIGHTS K772414 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Feb 1978. https://www.510kdatabase.net/k780041/ 1978-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k780041-lactate-dehydrogenase-fda-510k.jpg K780041 - LACTATE DEHYDROGENASE K780041 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Feb 1978. https://www.510kdatabase.net/k780042/ 1978-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k780042-hydorrybutyrate-dehydrogenase-fda-510k.jpg K780042 - HYDORRYBUTYRATE DEHYDROGENASE K780042 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Feb 1978. https://www.510kdatabase.net/k780056/ 1978-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k780056-oxygenator-holder-fda-510k.jpg K780056 - OXYGENATOR HOLDER K780056 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Feb 1978. https://www.510kdatabase.net/k772352/ 1978-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k772352-stac-system-additional-analytes-fda-510k.jpg K772352 - STAC SYSTEM - ADDITIONAL ANALYTES K772352 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Jan 1978. https://www.510kdatabase.net/k780039/ 1978-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k780039-aspartate-transaminase-fda-510k.jpg K780039 - ASPARTATE TRANSAMINASE K780039 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jan 1978. https://www.510kdatabase.net/k780040/ 1978-01-31 monthly 0.5 https://www.510kdatabase.net/og-image/k780040-alanine-transaminase-fda-510k.jpg K780040 - ALANINE TRANSAMINASE K780040 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jan 1978. https://www.510kdatabase.net/k770143/ 1978-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k770143-tqc-calibration-reference-for-platelets-fda-510k.jpg K770143 - TQC CALIBRATION REFERENCE FOR PLATELETS K770143 is a FDA 510(k) cleared hematology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Jan 1978. https://www.510kdatabase.net/k772368/ 1978-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k772368-spectacle-frame-op-tite-fda-510k.jpg K772368 - SPECTACLE FRAME, OP-TITE K772368 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Dentsply Intl.. Cleared Jan 1978. https://www.510kdatabase.net/k780066/ 1978-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k780066-cardiac-pacer-model-208-fda-510k.jpg K780066 - CARDIAC PACER, MODEL 208 K780066 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Jan 1978. https://www.510kdatabase.net/k780085/ 1978-01-30 monthly 0.5 https://www.510kdatabase.net/og-image/k780085-canereacher-fda-510k.jpg K780085 - CANE/REACHER K780085 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jan 1978. https://www.510kdatabase.net/k772099/ 1978-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k772099-printer-fda-510k.jpg K772099 - PRINTER K772099 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Jan 1978. https://www.510kdatabase.net/k772312/ 1978-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k772312-filterset-wy-injection-site-02-fda-510k.jpg K772312 - FILTERSET W/Y-INJECTION SITE, 0.2 K772312 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Jan 1978. https://www.510kdatabase.net/k772318/ 1978-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k772318-dialyzer-standard-code-5dm1780-fda-510k.jpg K772318 - DIALYZER STANDARD, CODE 5DM1780 K772318 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Jan 1978. https://www.510kdatabase.net/k772338/ 1978-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k772338-syringe-blood-sampling-arterial-fda-510k.jpg K772338 - SYRINGE, BLOOD, SAMPLING, ARTERIAL K772338 is a FDA 510(k) cleared hematology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 1978. https://www.510kdatabase.net/k772355/ 1978-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k772355-blood-line-comp-neg-press-pillow-fda-510k.jpg K772355 - BLOOD LINE COMP. NEG. PRESS. PILLOW K772355 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Jan 1978. https://www.510kdatabase.net/k772365/ 1978-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k772365-thermometer-sheaths-fda-510k.jpg K772365 - THERMOMETER SHEATHS K772365 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Jan 1978. https://www.510kdatabase.net/k772402/ 1978-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k772402-quadriplegic-urinary-drainage-valve-fda-510k.jpg K772402 - QUADRIPLEGIC URINARY DRAINAGE VALVE K772402 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jan 1978. https://www.510kdatabase.net/k772405/ 1978-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k772405-tubing-clamp-fda-510k.jpg K772405 - TUBING CLAMP K772405 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jan 1978. https://www.510kdatabase.net/k772419/ 1978-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k772419-heel-or-elbow-protector-fda-510k.jpg K772419 - HEEL OR ELBOW PROTECTOR K772419 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jan 1978. https://www.510kdatabase.net/k780061/ 1978-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k780061-pulse-generators-models-59725973-fda-510k.jpg K780061 - PULSE GENERATORS, MODELS 5972/5973 K780061 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jan 1978. https://www.510kdatabase.net/k772388/ 1978-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k772388-converse-gillies-needle-holder-fda-510k.jpg K772388 - CONVERSE-GILLIES NEEDLE HOLDER K772388 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Edward Weck, Inc.. Cleared Jan 1978. https://www.510kdatabase.net/k780052/ 1978-01-20 monthly 0.5 https://www.510kdatabase.net/og-image/k780052-prosthesis-double-cup-fda-510k.jpg K780052 - PROSTHESIS, DOUBLE CUP K780052 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jan 1978. https://www.510kdatabase.net/k772294/ 1978-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k772294-inspiron-manifold-double-fda-510k.jpg K772294 - INSPIRON MANIFOLD (DOUBLE) K772294 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 1978. https://www.510kdatabase.net/k772295/ 1978-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k772295-inspiron-manifold-single-fda-510k.jpg K772295 - INSPIRON MANIFOLD (SINGLE) K772295 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 1978. https://www.510kdatabase.net/k772296/ 1978-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k772296-inspiron-manifold-fda-510k.jpg K772296 - INSPIRON MANIFOLD K772296 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 1978. https://www.510kdatabase.net/k772357/ 1978-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k772357-pulse-generators-fda-510k.jpg K772357 - PULSE GENERATORS K772357 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jan 1978. https://www.510kdatabase.net/k772370/ 1978-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k772370-barraquer-oval-speculum-various-sizes-fda-510k.jpg K772370 - BARRAQUER OVAL SPECULUM-VARIOUS SIZES K772370 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Jan 1978. https://www.510kdatabase.net/k772372/ 1978-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k772372-roller-knife-fda-510k.jpg K772372 - ROLLER KNIFE K772372 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Edward Weck, Inc.. Cleared Jan 1978. https://www.510kdatabase.net/k772377/ 1978-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k772377-hildyard-post-nasal-forcep-fda-510k.jpg K772377 - HILDYARD POST NASAL FORCEP K772377 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Edward Weck, Inc.. Cleared Jan 1978. https://www.510kdatabase.net/k772380/ 1978-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k772380-farrior-oval-speculum-fda-510k.jpg K772380 - FARRIOR OVAL SPECULUM K772380 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Jan 1978. https://www.510kdatabase.net/k772381/ 1978-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k772381-ring-handle-retractors-fda-510k.jpg K772381 - RING HANDLE & RETRACTORS K772381 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Edward Weck, Inc.. Cleared Jan 1978. https://www.510kdatabase.net/k772384/ 1978-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k772384-myringotomy-knife-fda-510k.jpg K772384 - MYRINGOTOMY KNIFE K772384 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Edward Weck, Inc.. Cleared Jan 1978. https://www.510kdatabase.net/k772385/ 1978-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k772385-thin-bladed-nasal-speculum-fda-510k.jpg K772385 - THIN-BLADED NASAL SPECULUM K772385 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Jan 1978. https://www.510kdatabase.net/k772390/ 1978-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k772390-day-ear-hook-fda-510k.jpg K772390 - DAY EAR HOOK K772390 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Edward Weck, Inc.. Cleared Jan 1978. https://www.510kdatabase.net/k772391/ 1978-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k772391-boies-nasal-fracture-elevator-fda-510k.jpg K772391 - BOIES NASAL FRACTURE ELEVATOR K772391 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Edward Weck, Inc.. Cleared Jan 1978. https://www.510kdatabase.net/k772392/ 1978-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k772392-allport-mastoid-retractors-fda-510k.jpg K772392 - ALLPORT MASTOID RETRACTORS K772392 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Edward Weck, Inc.. Cleared Jan 1978. https://www.510kdatabase.net/k772396/ 1978-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k772396-alligator-cup-forceps-fda-510k.jpg K772396 - ALLIGATOR CUP FORCEPS K772396 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Edward Weck, Inc.. Cleared Jan 1978. https://www.510kdatabase.net/k772397/ 1978-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k772397-cottle-columella-forcep-fda-510k.jpg K772397 - COTTLE COLUMELLA FORCEP K772397 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Edward Weck, Inc.. Cleared Jan 1978. https://www.510kdatabase.net/k772398/ 1978-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k772398-cottle-lower-lateral-forceps-fda-510k.jpg K772398 - COTTLE LOWER LATERAL FORCEPS K772398 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Edward Weck, Inc.. Cleared Jan 1978. https://www.510kdatabase.net/k772399/ 1978-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k772399-dingman-zygoma-elevator-fda-510k.jpg K772399 - DINGMAN ZYGOMA ELEVATOR K772399 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Edward Weck, Inc.. Cleared Jan 1978. https://www.510kdatabase.net/k780001/ 1978-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k780001-epidural-lead-model-3481-fda-510k.jpg K780001 - EPIDURAL LEAD - MODEL 3481 K780001 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Jan 1978. https://www.510kdatabase.net/k780028/ 1978-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k780028-orthodontic-plastic-bracket-primer-fda-510k.jpg K780028 - ORTHODONTIC. PLASTIC BRACKET PRIMER K780028 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Jan 1978. https://www.510kdatabase.net/k780032/ 1978-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k780032-urinary-leg-bag-fda-510k.jpg K780032 - URINARY LEG BAG K780032 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 1978. https://www.510kdatabase.net/k780053/ 1978-01-17 monthly 0.5 https://www.510kdatabase.net/og-image/k780053-brace-tennis-elbow-fda-510k.jpg K780053 - BRACE, TENNIS ELBOW K780053 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jan 1978. https://www.510kdatabase.net/k771016/ 1978-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k771016-intermedullary-brush-fda-510k.jpg K771016 - INTERMEDULLARY BRUSH K771016 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Howmedica Corp.. Cleared Jan 1978. https://www.510kdatabase.net/k772191/ 1978-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k772191-testosterone-ria-kit-125i-fda-510k.jpg K772191 - TESTOSTERONE RIA KIT (125I) K772191 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jan 1978. https://www.510kdatabase.net/k772192/ 1978-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k772192-neonatal-tsh-ria-kit-125i-fda-510k.jpg K772192 - NEONATAL TSH RIA KIT (125I) K772192 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Jan 1978. https://www.510kdatabase.net/k772330/ 1978-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k772330-t4-ria-kit-fda-510k.jpg K772330 - T4 RIA KIT K772330 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jan 1978. https://www.510kdatabase.net/k772360/ 1978-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k772360-arrhythmia-module-fda-510k.jpg K772360 - ARRHYTHMIA MODULE K772360 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: General Electric Co.. Cleared Jan 1978. https://www.510kdatabase.net/k772203/ 1978-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k772203-ventricular-leads-fda-510k.jpg K772203 - VENTRICULAR LEADS K772203 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jan 1978. https://www.510kdatabase.net/k772317/ 1978-01-11 monthly 0.5 https://www.510kdatabase.net/og-image/k772317-ctt-system-model-b7800a-fda-510k.jpg K772317 - CT/T SYSTEM MODEL B7800A K772317 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jan 1978. https://www.510kdatabase.net/k772285/ 1978-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k772285-aca-lipase-verifiers-fda-510k.jpg K772285 - ACA LIPASE VERIFIERS K772285 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Jan 1978. https://www.510kdatabase.net/k772371/ 1978-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k772371-bayonet-surgical-instruments-fda-510k.jpg K772371 - BAYONET SURGICAL INSTRUMENTS K772371 is a FDA 510(k) cleared neurology medical device. Manufacturer: Edward Weck, Inc.. Cleared Jan 1978. https://www.510kdatabase.net/k772389/ 1978-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k772389-dandy-hemostatic-forceps-fda-510k.jpg K772389 - DANDY HEMOSTATIC FORCEPS K772389 is a FDA 510(k) cleared neurology medical device. Manufacturer: Edward Weck, Inc.. Cleared Jan 1978. https://www.510kdatabase.net/k772406/ 1978-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k772406-aesthesiometer-fda-510k.jpg K772406 - AESTHESIOMETER K772406 is a FDA 510(k) cleared neurology medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jan 1978. https://www.510kdatabase.net/k772095/ 1978-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k772095-hemagglutination-inhibition-test-fda-510k.jpg K772095 - HEMAGGLUTINATION INHIBITION TEST K772095 is a FDA 510(k) cleared immunology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Jan 1978. https://www.510kdatabase.net/k772234/ 1978-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k772234-cardiac-output-module-78231c-fda-510k.jpg K772234 - CARDIAC OUTPUT MODULE-78231C K772234 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Jan 1978. https://www.510kdatabase.net/k772364/ 1978-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k772364-auto-sampling-system-fda-510k.jpg K772364 - AUTO. SAMPLING SYSTEM K772364 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Jan 1978. https://www.510kdatabase.net/k772401/ 1978-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k772401-lap-board-wrim-fda-510k.jpg K772401 - LAP BOARD W/RIM K772401 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jan 1978. https://www.510kdatabase.net/k772410/ 1978-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k772410-resting-pan-splints-fda-510k.jpg K772410 - RESTING PAN SPLINTS K772410 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jan 1978. https://www.510kdatabase.net/k772411/ 1978-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k772411-platform-splints-fda-510k.jpg K772411 - PLATFORM SPLINTS K772411 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jan 1978. https://www.510kdatabase.net/k772413/ 1978-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k772413-pinch-guage-fda-510k.jpg K772413 - PINCH GUAGE K772413 is a FDA 510(k) cleared neurology medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jan 1978. https://www.510kdatabase.net/k772415/ 1978-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k772415-dynameter-50-lb-fda-510k.jpg K772415 - DYNAMETER 50 LB. K772415 is a FDA 510(k) cleared neurology medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jan 1978. https://www.510kdatabase.net/k772416/ 1978-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k772416-pre-formed-splint-blanks-fda-510k.jpg K772416 - PRE-FORMED SPLINT BLANKS K772416 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jan 1978. https://www.510kdatabase.net/k772417/ 1978-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k772417-sliding-board-fda-510k.jpg K772417 - SLIDING BOARD K772417 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jan 1978. https://www.510kdatabase.net/k772420/ 1978-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k772420-rear-fastening-safety-strap-fda-510k.jpg K772420 - REAR FASTENING SAFETY STRAP K772420 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jan 1978. https://www.510kdatabase.net/k772421/ 1978-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k772421-wheelchair-belt-fda-510k.jpg K772421 - WHEELCHAIR BELT K772421 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jan 1978. https://www.510kdatabase.net/k771770/ 1978-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k771770-xyrel-ra-models-59945995-fda-510k.jpg K771770 - XYREL-RA MODELS 5994/5995 K771770 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jan 1978. https://www.510kdatabase.net/k771786/ 1978-01-04 monthly 0.5 https://www.510kdatabase.net/og-image/k771786-cardiac-pulse-generators-59825983-fda-510k.jpg K771786 - CARDIAC PULSE GENERATORS 5982/5983 K771786 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Jan 1978. https://www.510kdatabase.net/k771422/ 1978-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k771422-patient-by-pass-fda-510k.jpg K771422 - PATIENT BY-PASS K771422 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quinton, Inc.. Cleared Jan 1978. https://www.510kdatabase.net/k771425/ 1978-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k771425-a-v-shunt-extension-fda-510k.jpg K771425 - A-V SHUNT EXTENSION K771425 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quinton, Inc.. Cleared Jan 1978. https://www.510kdatabase.net/k771482/ 1978-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k771482-rinse-block-connector-fda-510k.jpg K771482 - RINSE BLOCK CONNECTOR K771482 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quinton, Inc.. Cleared Jan 1978. https://www.510kdatabase.net/k771972/ 1978-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k771972-5um-filterset-with-y-injection-site-fda-510k.jpg K771972 - 5UM FILTERSET WITH Y-INJECTION SITE K771972 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Jan 1978. https://www.510kdatabase.net/k771977/ 1978-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k771977-cardiac-output-computer-model-701-fda-510k.jpg K771977 - CARDIAC OUTPUT COMPUTER MODEL 701 K771977 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jan 1978. https://www.510kdatabase.net/k772063/ 1978-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k772063-catheter-intracranial-press-monitor-fda-510k.jpg K772063 - CATHETER, INTRACRANIAL PRESS. MONITOR. K772063 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cordis Corp.. Cleared Jan 1978. https://www.510kdatabase.net/k772256/ 1978-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k772256-crown-bridge-alloy-fda-510k.jpg K772256 - CROWN & BRIDGE ALLOY K772256 is a FDA 510(k) cleared dental medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jan 1978. https://www.510kdatabase.net/k772278/ 1978-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k772278-fotofill-activator-light-fda-510k.jpg K772278 - FOTOFILL ACTIVATOR LIGHT K772278 is a FDA 510(k) cleared dental medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jan 1978. https://www.510kdatabase.net/k772279/ 1978-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k772279-fotofill-dental-restorative-fda-510k.jpg K772279 - FOTOFILL DENTAL RESTORATIVE K772279 is a FDA 510(k) cleared dental medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jan 1978. https://www.510kdatabase.net/k771429/ 1977-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k771429-disp-teflon-connhctor-fda-510k.jpg K771429 - DISP. TEFLON CONNHCTOR K771429 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quinton, Inc.. Cleared Dec 1977. https://www.510kdatabase.net/k772170/ 1977-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k772170-emit-centrifichem-thyroxine-assay-fda-510k.jpg K772170 - EMIT CENTRIFICHEM THYROXINE ASSAY K772170 is a FDA 510(k) cleared immunology medical device. Manufacturer: Syva Co.. Cleared Dec 1977. https://www.510kdatabase.net/k772184/ 1977-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k772184-x-ray-system-for-dental-application-fda-510k.jpg K772184 - X-RAY SYSTEM FOR DENTAL APPLICATION K772184 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Dec 1977. https://www.510kdatabase.net/k772188/ 1977-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k772188-fsh-ria-kit-125i-fda-510k.jpg K772188 - FSH RIA KIT (125I) K772188 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Dec 1977. https://www.510kdatabase.net/k772222/ 1977-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k772222-nebulizer-set-2c7105-fda-510k.jpg K772222 - NEBULIZER SET-2C7105 K772222 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Dec 1977. https://www.510kdatabase.net/k771426/ 1977-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k771426-pediatric-infusion-t-fda-510k.jpg K771426 - PEDIATRIC INFUSION T K771426 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quinton, Inc.. Cleared Dec 1977. https://www.510kdatabase.net/k771909/ 1977-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k771909-dual-wavelength-photometer-1177-fda-510k.jpg K771909 - DUAL WAVELENGTH PHOTOMETER, 1177 K771909 is a FDA 510(k) cleared immunology medical device. Manufacturer: Abbott Laboratories. Cleared Dec 1977. https://www.510kdatabase.net/k772098/ 1977-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k772098-digoxin-reag-kit-for-use-waria-ii-sys-fda-510k.jpg K772098 - DIGOXIN REAG. KIT FOR USE W/ARIA-II SYS K772098 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Dec 1977. https://www.510kdatabase.net/k772120/ 1977-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k772120-total-hip-charnely-type-fda-510k.jpg K772120 - TOTAL HIP, CHARNELY TYPE K772120 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Dec 1977. https://www.510kdatabase.net/k772138/ 1977-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k772138-endotracheal-tube-fda-510k.jpg K772138 - ENDOTRACHEAL TUBE K772138 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Medline Industries, Inc.. Cleared Dec 1977. https://www.510kdatabase.net/k772179/ 1977-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k772179-emit-antiepileptic-drug-assays-fda-510k.jpg K772179 - EMIT ANTIEPILEPTIC DRUG ASSAYS K772179 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Dec 1977. https://www.510kdatabase.net/k772202/ 1977-12-20 monthly 0.5 https://www.510kdatabase.net/og-image/k772202-pulse-generator-a-v-seq-fda-510k.jpg K772202 - PULSE GENERATOR, A-V SEQ. K772202 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Dec 1977. https://www.510kdatabase.net/k772283/ 1977-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k772283-rx-pedestal-table-fda-510k.jpg K772283 - RX PEDESTAL TABLE K772283 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Dec 1977. https://www.510kdatabase.net/k772199/ 1977-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k772199-cauteries-hot-wire-disp-fda-510k.jpg K772199 - CAUTERIES, HOT WIRE, DISP. K772199 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Intermedics, Inc.. Cleared Dec 1977. https://www.510kdatabase.net/k772237/ 1977-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k772237-oxygenator-bubble-fda-510k.jpg K772237 - OXYGENATOR, BUBBLE K772237 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Dec 1977. https://www.510kdatabase.net/k771672/ 1977-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k771672-microcult-id-fda-510k.jpg K771672 - MICROCULT-ID K771672 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Dec 1977. https://www.510kdatabase.net/k772094/ 1977-12-08 monthly 0.5 https://www.510kdatabase.net/og-image/k772094-lifecare-iv-pump-model-iii-fda-510k.jpg K772094 - LIFECARE I.V. PUMP - MODEL III K772094 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Dec 1977. https://www.510kdatabase.net/k772088/ 1977-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k772088-ames-t-3-uptake-strip-test-fda-510k.jpg K772088 - AMES T-3 UPTAKE STRIP TEST K772088 is a FDA 510(k) cleared immunology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Dec 1977. https://www.510kdatabase.net/k771511/ 1977-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k771511-total-knee-prosthesis-nonconstrained-fda-510k.jpg K771511 - TOTAL KNEE PROSTHESIS-NONCONSTRAINED K771511 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: 3M Company. Cleared Nov 1977. https://www.510kdatabase.net/k771784/ 1977-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k771784-iopsy-tray-for-soft-tissue-biopsy-fda-510k.jpg K771784 - IOPSY TRAY FOR SOFT TISSUE BIOPSY K771784 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Nov 1977. https://www.510kdatabase.net/k771875/ 1977-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k771875-ultrafiltration-monitor-5m9034-fda-510k.jpg K771875 - ULTRAFILTRATION MONITOR 5M9034 K771875 is a FDA 510(k) cleared hematology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Nov 1977. https://www.510kdatabase.net/k771412/ 1977-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k771412-ligaclip-multiple-clip-applier-fda-510k.jpg K771412 - LIGACLIP MULTIPLE CLIP APPLIER K771412 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Nov 1977. https://www.510kdatabase.net/k771413/ 1977-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k771413-ligaclip-multiple-ligating-clips-fda-510k.jpg K771413 - LIGACLIP MULTIPLE LIGATING CLIPS K771413 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Nov 1977. https://www.510kdatabase.net/k771420/ 1977-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k771420-beta-cap-fda-510k.jpg K771420 - BETA-CAP K771420 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quinton, Inc.. Cleared Nov 1977. https://www.510kdatabase.net/k771483/ 1977-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k771483-catheter-finger-grip-fda-510k.jpg K771483 - CATHETER FINGER GRIP K771483 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quinton, Inc.. Cleared Nov 1977. https://www.510kdatabase.net/k771861/ 1977-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k771861-catheter-cebtral-venous-2n1501-fda-510k.jpg K771861 - CATHETER, CEBTRAL VENOUS, 2N1501 K771861 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Nov 1977. https://www.510kdatabase.net/k772082/ 1977-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k772082-enzac-uric-acid-100-test-kit-fda-510k.jpg K772082 - ENZAC URIC ACID 100-TEST KIT K772082 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Nov 1977. https://www.510kdatabase.net/k772104/ 1977-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k772104-pacing-lead-model-6991a-fda-510k.jpg K772104 - PACING LEAD MODEL 6991A K772104 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Nov 1977. https://www.510kdatabase.net/k772144/ 1977-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k772144-catheter-disp-external-male-fda-510k.jpg K772144 - CATHETER, DISP., EXTERNAL, MALE K772144 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Medline Industries, Inc.. Cleared Nov 1977. https://www.510kdatabase.net/k772150/ 1977-11-28 monthly 0.5 https://www.510kdatabase.net/og-image/k772150-dialysis-drainage-unit-peritoneal-fda-510k.jpg K772150 - DIALYSIS DRAINAGE UNIT, PERITONEAL K772150 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 1977. https://www.510kdatabase.net/k771523/ 1977-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k771523-latelet-retention-column-fda-510k.jpg K771523 - LATELET RETENTION COLUMN K771523 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Nov 1977. https://www.510kdatabase.net/k772052/ 1977-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k772052-physiological-recorder-model-721a-fda-510k.jpg K772052 - PHYSIOLOGICAL RECORDER MODEL 721A K772052 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Nov 1977. https://www.510kdatabase.net/k772054/ 1977-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k772054-physiological-recorder-model-740-fda-510k.jpg K772054 - PHYSIOLOGICAL RECORDER MODEL 740 K772054 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Nov 1977. https://www.510kdatabase.net/k772056/ 1977-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k772056-physiological-monitor-model-871-fda-510k.jpg K772056 - PHYSIOLOGICAL MONITOR MODEL 871 K772056 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Nov 1977. https://www.510kdatabase.net/k772097/ 1977-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k772097-heartrate-meter-model-650-pn-000119-fda-510k.jpg K772097 - HEARTRATE METER MODEL 650, P/N 000119 K772097 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Nov 1977. https://www.510kdatabase.net/k772132/ 1977-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k772132-amplifier-module-78211a-ecg-fda-510k.jpg K772132 - AMPLIFIER MODULE, 78211A ECG K772132 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Nov 1977. https://www.510kdatabase.net/k772166/ 1977-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k772166-emit-theophylline-control-fda-510k.jpg K772166 - EMIT THEOPHYLLINE CONTROL K772166 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Nov 1977. https://www.510kdatabase.net/k772167/ 1977-11-22 monthly 0.5 https://www.510kdatabase.net/og-image/k772167-emit-lidocaine-control-fda-510k.jpg K772167 - EMIT LIDOCAINE CONTROL K772167 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Nov 1977. https://www.510kdatabase.net/k772103/ 1977-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k772103-bipolar-leads-disp-fda-510k.jpg K772103 - BIPOLAR LEADS, DISP. K772103 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Nov 1977. https://www.510kdatabase.net/k772123/ 1977-11-21 monthly 0.5 https://www.510kdatabase.net/og-image/k772123-tomographic-system-computerized-fda-510k.jpg K772123 - TOMOGRAPHIC SYSTEM, COMPUTERIZED K772123 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared Nov 1977. https://www.510kdatabase.net/k772036/ 1977-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k772036-in-line-burette-set-fda-510k.jpg K772036 - IN-LINE BURETTE SET K772036 is a FDA 510(k) cleared hematology medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1977. https://www.510kdatabase.net/k772113/ 1977-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k772113-urinary-drainage-bag-2d9017-fda-510k.jpg K772113 - URINARY DRAINAGE BAG 2D9017 K772113 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Nov 1977. https://www.510kdatabase.net/k771619/ 1977-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k771619-proximate-disp-skin-stapler-fda-510k.jpg K771619 - PROXIMATE DISP. SKIN STAPLER K771619 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Nov 1977. https://www.510kdatabase.net/k771393/ 1977-11-11 monthly 0.5 https://www.510kdatabase.net/og-image/k771393-elhctronic-sphygmomanometer-fda-510k.jpg K771393 - ELHCTRONIC SPHYGMOMANOMETER K771393 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 1977. https://www.510kdatabase.net/k771923/ 1977-11-11 monthly 0.5 https://www.510kdatabase.net/og-image/k771923-fastchem-bun-fda-510k.jpg K771923 - FASTCHEM BUN K771923 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Nov 1977. https://www.510kdatabase.net/k772081/ 1977-11-11 monthly 0.5 https://www.510kdatabase.net/og-image/k772081-nail-intramedullary-flexible-fda-510k.jpg K772081 - NAIL, INTRAMEDULLARY, FLEXIBLE K772081 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Nov 1977. https://www.510kdatabase.net/k771394/ 1977-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k771394-electronic-stethescope-fda-510k.jpg K771394 - ELECTRONIC STETHESCOPE K771394 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 1977. https://www.510kdatabase.net/k771669/ 1977-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k771669-diag-kit-for-total-antithrombin-iii-fda-510k.jpg K771669 - DIAG. KIT FOR TOTAL ANTITHROMBIN III K771669 is a FDA 510(k) cleared hematology medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1977. https://www.510kdatabase.net/k771776/ 1977-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k771776-ecg-cluster-electrode-fda-510k.jpg K771776 - ECG CLUSTER ELECTRODE K771776 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 1977. https://www.510kdatabase.net/k771866/ 1977-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k771866-troutman-corneal-punch-fda-510k.jpg K771866 - TROUTMAN CORNEAL PUNCH K771866 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Edward Weck, Inc.. Cleared Nov 1977. https://www.510kdatabase.net/k772048/ 1977-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k772048-single-dual-channel-recorder-fda-510k.jpg K772048 - SINGLE & DUAL CHANNEL RECORDER K772048 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Nov 1977. https://www.510kdatabase.net/k772053/ 1977-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k772053-line-charger-model-lc-100-fda-510k.jpg K772053 - LINE CHARGER MODEL LC-100 K772053 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Nov 1977. https://www.510kdatabase.net/k771728/ 1977-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k771728-auto-leucocyte-differ-analyzer-d90-fda-510k.jpg K771728 - AUTO. LEUCOCYTE DIFFER. ANALYZER D/90 K771728 is a FDA 510(k) cleared hematology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Nov 1977. https://www.510kdatabase.net/k771821/ 1977-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k771821-stac-system-fda-510k.jpg K771821 - STAC SYSTEM K771821 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Nov 1977. https://www.510kdatabase.net/k771908/ 1977-11-07 monthly 0.5 https://www.510kdatabase.net/og-image/k771908-iso-shield-saliva-absorbers-fda-510k.jpg K771908 - ISO-SHIELD SALIVA ABSORBERS K771908 is a FDA 510(k) cleared dental medical device. Manufacturer: 3M Company. Cleared Nov 1977. https://www.510kdatabase.net/k771380/ 1977-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k771380-elapsed-time-indicator-model-21361a-fda-510k.jpg K771380 - ELAPSED TIME INDICATOR MODEL 21361A K771380 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Nov 1977. https://www.510kdatabase.net/k771720/ 1977-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k771720-amido-black-concentrate-fda-510k.jpg K771720 - AMIDO BLACK CONCENTRATE K771720 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Nov 1977. https://www.510kdatabase.net/k771939/ 1977-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k771939-stac-system-addi-analytes-fda-510k.jpg K771939 - STAC SYSTEM-ADDI. ANALYTES K771939 is a FDA 510(k) cleared immunology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Nov 1977. https://www.510kdatabase.net/k771991/ 1977-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k771991-cardiac-output-thermodilution-module-fda-510k.jpg K771991 - CARDIAC OUTPUT THERMODILUTION MODULE K771991 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1977. https://www.510kdatabase.net/k772057/ 1977-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k772057-bipolar-pacemaker-model-224-fda-510k.jpg K772057 - BIPOLAR PACEMAKER MODEL 224 K772057 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Nov 1977. https://www.510kdatabase.net/k772058/ 1977-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k772058-lead-adaptor-kit-model-5866-21-fda-510k.jpg K772058 - LEAD ADAPTOR KIT MODEL 5866-21 K772058 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medtronic Vascular. Cleared Nov 1977. https://www.510kdatabase.net/k771891/ 1977-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k771891-catheter-umbilical-vicra-fda-510k.jpg K771891 - CATHETER, UMBILICAL, VICRA K771891 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Nov 1977. https://www.510kdatabase.net/k772014/ 1977-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k772014-ames-t-4-strip-test-fda-510k.jpg K772014 - AMES T-4 STRIP TEST K772014 is a FDA 510(k) cleared immunology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Nov 1977. https://www.510kdatabase.net/k772020/ 1977-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k772020-cloth-adhesive-tape-fda-510k.jpg K772020 - CLOTH ADHESIVE TAPE K772020 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Nov 1977. https://www.510kdatabase.net/k771798/ 1977-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k771798-aca-bilirubin-calibrator-fda-510k.jpg K771798 - ACA BILIRUBIN CALIBRATOR K771798 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Oct 1977. https://www.510kdatabase.net/k772013/ 1977-10-28 monthly 0.5 https://www.510kdatabase.net/og-image/k772013-percupass-tunneling-tool-model-3452-fda-510k.jpg K772013 - PERCUPASS TUNNELING TOOL MODEL 3452 K772013 is a FDA 510(k) cleared neurology medical device. Manufacturer: Medtronic Vascular. Cleared Oct 1977. https://www.510kdatabase.net/k771851/ 1977-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k771851-arthroscope-operative-knife-set-fda-510k.jpg K771851 - ARTHROSCOPE OPERATIVE KNIFE SET K771851 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Oct 1977. https://www.510kdatabase.net/k771352/ 1977-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k771352-electrosurg-patient-grounding-plate-fda-510k.jpg K771352 - ELECTROSURG. PATIENT GROUNDING PLATE K771352 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 1977. https://www.510kdatabase.net/k771421/ 1977-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k771421-catheteo-clamp-fda-510k.jpg K771421 - CATHETEO CLAMP K771421 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quinton, Inc.. Cleared Oct 1977. https://www.510kdatabase.net/k771484/ 1977-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k771484-rinse-block-assem-d-w-peri-dialysis-fda-510k.jpg K771484 - RINSE BLOCK ASSEM, D-W PERI. DIALYSIS K771484 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quinton, Inc.. Cleared Oct 1977. https://www.510kdatabase.net/k771496/ 1977-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k771496-chemcodechemtek-system-fda-510k.jpg K771496 - CHEMCODE/CHEMTEK SYSTEM K771496 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Oct 1977. https://www.510kdatabase.net/k771507/ 1977-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k771507-multistat-iii-bicarbonate-test-fda-510k.jpg K771507 - MULTISTAT III BICARBONATE TEST K771507 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Oct 1977. https://www.510kdatabase.net/k771755/ 1977-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k771755-9-way-urine-test-with-ascorbic-fda-510k.jpg K771755 - 9-WAY URINE TEST WITH ASCORBIC K771755 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Oct 1977. https://www.510kdatabase.net/k771767/ 1977-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k771767-seralute-tsh-ria-fda-510k.jpg K771767 - SERALUTE TSH (RIA) K771767 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Oct 1977. https://www.510kdatabase.net/k771777/ 1977-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k771777-ponceau-s-concentrate-fda-510k.jpg K771777 - PONCEAU S CONCENTRATE K771777 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Oct 1977. https://www.510kdatabase.net/k771797/ 1977-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k771797-aca-triglyceride-calibrator-fda-510k.jpg K771797 - ACA TRIGLYCERIDE CALIBRATOR K771797 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Oct 1977. https://www.510kdatabase.net/k771800/ 1977-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k771800-aca-glutamyl-transferase-fda-510k.jpg K771800 - ACA GLUTAMYL TRANSFERASE K771800 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Oct 1977. https://www.510kdatabase.net/k771801/ 1977-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k771801-aca-carbon-dioxide-calibrator-fda-510k.jpg K771801 - ACA CARBON DIOXIDE CALIBRATOR K771801 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Oct 1977. https://www.510kdatabase.net/k771802/ 1977-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k771802-aca-iron-calibrator-fda-510k.jpg K771802 - ACA IRON CALIBRATOR K771802 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Oct 1977. https://www.510kdatabase.net/k771803/ 1977-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k771803-aca-phosphorus-calibrator-fda-510k.jpg K771803 - ACA PHOSPHORUS CALIBRATOR K771803 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Oct 1977. https://www.510kdatabase.net/k771804/ 1977-10-25 monthly 0.5 https://www.510kdatabase.net/og-image/k771804-aca-ammonia-calibrator-fda-510k.jpg K771804 - ACA AMMONIA CALIBRATOR K771804 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Oct 1977. https://www.510kdatabase.net/k771822/ 1977-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k771822-bg-ii-analyzer-fda-510k.jpg K771822 - BG II ANALYZER K771822 is a FDA 510(k) cleared hematology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Oct 1977. https://www.510kdatabase.net/k771857/ 1977-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k771857-automixer-kodak-fda-510k.jpg K771857 - AUTOMIXER, KODAK K771857 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Oct 1977. https://www.510kdatabase.net/k771916/ 1977-10-19 monthly 0.5 https://www.510kdatabase.net/og-image/k771916-procedure-no-555-fda-510k.jpg K771916 - PROCEDURE NO. 555 K771916 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Oct 1977. https://www.510kdatabase.net/k770814/ 1977-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k770814-catheter-uretheral-fda-510k.jpg K770814 - CATHETER, URETHERAL K770814 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 1977. https://www.510kdatabase.net/k770943/ 1977-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k770943-endoscope-urological-female-fda-510k.jpg K770943 - ENDOSCOPE, UROLOGICAL, FEMALE K770943 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 1977. https://www.510kdatabase.net/k771177/ 1977-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k771177-surgical-stapling-instru-auto-suture-fda-510k.jpg K771177 - SURGICAL STAPLING INSTRU., AUTO, SUTURE K771177 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Oct 1977. https://www.510kdatabase.net/k771178/ 1977-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k771178-disp-loading-unit-auto-suture-fda-510k.jpg K771178 - DISP. LOADING UNIT, AUTO, SUTURE K771178 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Oct 1977. https://www.510kdatabase.net/k771337/ 1977-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k771337-il-model-643-flame-photometer-fda-510k.jpg K771337 - I.L. MODEL 643 FLAME PHOTOMETER K771337 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Oct 1977. https://www.510kdatabase.net/k771428/ 1977-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k771428-tenckhoff-peritoneal-tubing-adapt-fda-510k.jpg K771428 - TENCKHOFF PERITONEAL TUBING ADAPT. K771428 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quinton, Inc.. Cleared Oct 1977. https://www.510kdatabase.net/k771592/ 1977-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k771592-statlyte-analyzer-fda-510k.jpg K771592 - STAT/LYTE ANALYZER K771592 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Oct 1977. https://www.510kdatabase.net/k771713/ 1977-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k771713-tek-chek-2-fda-510k.jpg K771713 - TEK-CHEK-2 K771713 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Oct 1977. https://www.510kdatabase.net/k771721/ 1977-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k771721-barbital-buffer-fda-510k.jpg K771721 - BARBITAL BUFFER K771721 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Oct 1977. https://www.510kdatabase.net/k771796/ 1977-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k771796-ruba-nost-test-kits-fda-510k.jpg K771796 - RUBA-NOST TEST KITS K771796 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Oct 1977. https://www.510kdatabase.net/k771850/ 1977-10-18 monthly 0.5 https://www.510kdatabase.net/og-image/k771850-uroflow-cystometer-system-fda-510k.jpg K771850 - UROFLOW-CYSTOMETER SYSTEM K771850 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Oct 1977. https://www.510kdatabase.net/k771525/ 1977-10-14 monthly 0.5 https://www.510kdatabase.net/og-image/k771525-125-i-digoxin-ria-kit-fda-510k.jpg K771525 - 125 I DIGOXIN RIA KIT K771525 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Oct 1977. https://www.510kdatabase.net/k771657/ 1977-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k771657-emit-thyroxine-control-fda-510k.jpg K771657 - EMIT THYROXINE CONTROL K771657 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Oct 1977. https://www.510kdatabase.net/k771245/ 1977-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k771245-model-22-analyzer-fda-510k.jpg K771245 - MODEL 2/2 ANALYZER K771245 is a FDA 510(k) cleared hematology medical device. Manufacturer: Eastman Kodak Company. Cleared Oct 1977. https://www.510kdatabase.net/k771638/ 1977-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k771638-igoxin-solid-phase-ria-fda-510k.jpg K771638 - IGOXIN SOLID PHASE RIA K771638 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1977. https://www.510kdatabase.net/k771855/ 1977-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k771855-omnicor-programmer-model-222a-fda-510k.jpg K771855 - OMNICOR PROGRAMMER MODEL 222A K771855 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Oct 1977. https://www.510kdatabase.net/k771708/ 1977-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k771708-worrell-patella-fda-510k.jpg K771708 - WORRELL PATELLA K771708 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Oct 1977. https://www.510kdatabase.net/k771709/ 1977-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k771709-worrell-trial-patella-fda-510k.jpg K771709 - WORRELL TRIAL PATELLA K771709 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Oct 1977. https://www.510kdatabase.net/k771710/ 1977-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k771710-worrell-patella-template-fda-510k.jpg K771710 - WORRELL PATELLA TEMPLATE K771710 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Oct 1977. https://www.510kdatabase.net/k771825/ 1977-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k771825-carba-linguarduc-fda-510k.jpg K771825 - CARBA LINGUARDUC K771825 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: C.R. Bard, Inc.. Cleared Oct 1977. https://www.510kdatabase.net/k771799/ 1977-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k771799-aca-alcohol-calibrators-fda-510k.jpg K771799 - ACA ALCOHOL CALIBRATORS K771799 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Oct 1977. https://www.510kdatabase.net/k771805/ 1977-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k771805-aca-salicylate-calibrator-fda-510k.jpg K771805 - ACA SALICYLATE CALIBRATOR K771805 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Oct 1977. https://www.510kdatabase.net/k771859/ 1977-10-04 monthly 0.5 https://www.510kdatabase.net/og-image/k771859-needle-holder-microvascular-fda-510k.jpg K771859 - NEEDLE HOLDER, MICROVASCULAR K771859 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Edward Weck, Inc.. Cleared Oct 1977. https://www.510kdatabase.net/k771112/ 1977-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k771112-auto-suture-r-clip-fda-510k.jpg K771112 - AUTO SUTURE R CLIP K771112 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Sep 1977. https://www.510kdatabase.net/k771113/ 1977-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k771113-auto-suture-r-clip-instrument-fda-510k.jpg K771113 - AUTO SUTURE R CLIP INSTRUMENT K771113 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Sep 1977. https://www.510kdatabase.net/k771515/ 1977-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k771515-suture-tissue-approximating-forcep-fda-510k.jpg K771515 - SUTURE TISSUE APPROXIMATING FORCEP K771515 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Sep 1977. https://www.510kdatabase.net/k771640/ 1977-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k771640-suture-clip-remover-fda-510k.jpg K771640 - SUTURE CLIP REMOVER K771640 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: United States Surgical, A Division of Tyco Healthc. Cleared Sep 1977. https://www.510kdatabase.net/k771750/ 1977-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k771750-rf-choke-cable-fda-510k.jpg K771750 - RF CHOKE CABLE K771750 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Sep 1977. https://www.510kdatabase.net/k771775/ 1977-09-30 monthly 0.5 https://www.510kdatabase.net/og-image/k771775-colorplast-transverse-system-fda-510k.jpg K771775 - COLORPLAST TRANSVERSE SYSTEM K771775 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Sep 1977. https://www.510kdatabase.net/k771594/ 1977-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k771594-primary-piggyback-venoset-w-filter-fda-510k.jpg K771594 - PRIMARY PIGGYBACK VENOSET W/ FILTER K771594 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1977. https://www.510kdatabase.net/k771744/ 1977-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k771744-osteotomes-for-cutting-bonh-fda-510k.jpg K771744 - OSTEOTOMES FOR CUTTING BONH K771744 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Depuy, Inc.. Cleared Sep 1977. https://www.510kdatabase.net/k771745/ 1977-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k771745-rasps-for-scraping-bone-fda-510k.jpg K771745 - RASPS FOR SCRAPING BONE K771745 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Depuy, Inc.. Cleared Sep 1977. https://www.510kdatabase.net/k771747/ 1977-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k771747-periosteal-elevator-fda-510k.jpg K771747 - PERIOSTEAL ELEVATOR K771747 is a FDA 510(k) cleared dental medical device. Manufacturer: Depuy, Inc.. Cleared Sep 1977. https://www.510kdatabase.net/k771748/ 1977-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k771748-intra-oral-x-ray-cones-fda-510k.jpg K771748 - INTRA ORAL X-RAY CONES K771748 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Sep 1977. https://www.510kdatabase.net/k771751/ 1977-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k771751-disp-electrosurgery-pencil-fda-510k.jpg K771751 - DISP. ELECTROSURGERY PENCIL K771751 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Sep 1977. https://www.510kdatabase.net/k771752/ 1977-09-28 monthly 0.5 https://www.510kdatabase.net/og-image/k771752-finger-tip-control-pencil-fda-510k.jpg K771752 - FINGER TIP CONTROL PENCIL K771752 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Sep 1977. https://www.510kdatabase.net/k771743/ 1977-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k771743-surg-scissors-for-cutting-tissue-fda-510k.jpg K771743 - SURG. SCISSORS FOR CUTTING TISSUE K771743 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Depuy, Inc.. Cleared Sep 1977. https://www.510kdatabase.net/k771746/ 1977-09-26 monthly 0.5 https://www.510kdatabase.net/og-image/k771746-forceps-fda-510k.jpg K771746 - FORCEPS K771746 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Depuy, Inc.. Cleared Sep 1977. https://www.510kdatabase.net/k771604/ 1977-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k771604-spectrophotometeo-il-model-651-fda-510k.jpg K771604 - SPECTROPHOTOMETEO IL MODEL 651 K771604 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 1977. https://www.510kdatabase.net/k771656/ 1977-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k771656-prolactin-ria-diag-kit-fda-510k.jpg K771656 - PROLACTIN RIA DIAG. KIT K771656 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1977. https://www.510kdatabase.net/k771691/ 1977-09-22 monthly 0.5 https://www.510kdatabase.net/og-image/k771691-angled-forcep-applier-fda-510k.jpg K771691 - ANGLED FORCEP APPLIER K771691 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Sep 1977. https://www.510kdatabase.net/k771547/ 1977-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k771547-petites-between-period-protectors-fda-510k.jpg K771547 - PETITES BETWEEN-PERIOD PROTECTORS K771547 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: 3M Company. Cleared Sep 1977. https://www.510kdatabase.net/k771628/ 1977-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k771628-nsulin-ria-kit-125i-fda-510k.jpg K771628 - NSULIN RIA KIT 125I K771628 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1977. https://www.510kdatabase.net/k771682/ 1977-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k771682-min-r-cassette-fda-510k.jpg K771682 - MIN-R CASSETTE K771682 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Sep 1977. https://www.510kdatabase.net/k771697/ 1977-09-20 monthly 0.5 https://www.510kdatabase.net/og-image/k771697-cardio-exercise-treadmill-550-fda-510k.jpg K771697 - CARDIO-EXERCISE TREADMILL 550 K771697 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Quinton, Inc.. Cleared Sep 1977. https://www.510kdatabase.net/k771375/ 1977-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k771375-pressure-module-5m1247-fda-510k.jpg K771375 - PRESSURE MODULE 5M1247 K771375 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Sep 1977. https://www.510kdatabase.net/k771603/ 1977-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k771603-immochemistry-system-fda-510k.jpg K771603 - IMMOCHEMISTRY SYSTEM K771603 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Sep 1977. https://www.510kdatabase.net/k771608/ 1977-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k771608-a-gent-triglycerides-fda-510k.jpg K771608 - A-GENT TRIGLYCERIDES K771608 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1977. https://www.510kdatabase.net/k771696/ 1977-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k771696-emodialysis-del-sys-model-7110-fda-510k.jpg K771696 - EMODIALYSIS DEL. SYS. MODEL 7110 K771696 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1977. https://www.510kdatabase.net/k771369/ 1977-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k771369-liq-scintillation-spectrophotometeo-fda-510k.jpg K771369 - LIQ. SCINTILLATION SPECTROPHOTOMETEO K771369 is a FDA 510(k) cleared radiology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Sep 1977. https://www.510kdatabase.net/k771681/ 1977-09-14 monthly 0.5 https://www.510kdatabase.net/og-image/k771681-ortho-h-film-fda-510k.jpg K771681 - ORTHO H FILM K771681 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Sep 1977. https://www.510kdatabase.net/k771473/ 1977-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k771473-multistat-iii-y-gt-test-fda-510k.jpg K771473 - MULTISTAT III Y GT TEST K771473 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 1977. https://www.510kdatabase.net/k771474/ 1977-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k771474-multistat-iii-x-hbdh-test-fda-510k.jpg K771474 - MULTISTAT III X-HBDH TEST K771474 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 1977. https://www.510kdatabase.net/k771475/ 1977-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k771475-multistat-iii-albumin-test-fda-510k.jpg K771475 - MULTISTAT III ALBUMIN TEST K771475 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 1977. https://www.510kdatabase.net/k771508/ 1977-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k771508-multistat-iii-cholesterol-test-fda-510k.jpg K771508 - MULTISTAT III CHOLESTEROL TEST K771508 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 1977. https://www.510kdatabase.net/k771509/ 1977-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k771509-multistat-iii-uric-acid-test-fda-510k.jpg K771509 - MULTISTAT III URIC ACID TEST K771509 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 1977. https://www.510kdatabase.net/k771582/ 1977-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k771582-holesterol-delta-test-assay-fda-510k.jpg K771582 - HOLESTEROL DELTA TEST ASSAY K771582 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1977. https://www.510kdatabase.net/k771584/ 1977-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k771584-arteoial-blood-sampling-kit-2d9014-fda-510k.jpg K771584 - ARTEOIAL BLOOD SAMPLING KIT 2D9014 K771584 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Sep 1977. https://www.510kdatabase.net/k771621/ 1977-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k771621-multistat-iii-total-bilirubin-test-fda-510k.jpg K771621 - MULTISTAT III, TOTAL BILIRUBIN TEST K771621 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 1977. https://www.510kdatabase.net/k771622/ 1977-09-13 monthly 0.5 https://www.510kdatabase.net/og-image/k771622-multistat-iii-amylase-test-fda-510k.jpg K771622 - MULTISTAT III, AMYLASE TEST K771622 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 1977. https://www.510kdatabase.net/k771004/ 1977-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k771004-amhs-blood-analy-triglyceoides-reag-ki-fda-510k.jpg K771004 - AMHS BLOOD ANALY. TRIGLYCEOIDES REAG. KI K771004 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Sep 1977. https://www.510kdatabase.net/k771468/ 1977-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k771468-multistat-iii-calcium-test-fda-510k.jpg K771468 - MULTISTAT III CALCIUM TEST K771468 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 1977. https://www.510kdatabase.net/k771469/ 1977-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k771469-multistat-iii-magnesium-test-fda-510k.jpg K771469 - MULTISTAT III MAGNESIUM TEST K771469 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 1977. https://www.510kdatabase.net/k771470/ 1977-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k771470-multistat-iii-alkaline-phosphatase-fda-510k.jpg K771470 - MULTISTAT III ALKALINE PHOSPHATASE K771470 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 1977. https://www.510kdatabase.net/k771471/ 1977-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k771471-multistat-iii-glucose-test-fda-510k.jpg K771471 - MULTISTAT III GLUCOSE TEST K771471 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 1977. https://www.510kdatabase.net/k771476/ 1977-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k771476-multistat-iii-total-protein-test-fda-510k.jpg K771476 - MULTISTAT III TOTAL PROTEIN TEST K771476 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 1977. https://www.510kdatabase.net/k771477/ 1977-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k771477-multistat-iii-phosphorous-test-fda-510k.jpg K771477 - MULTISTAT III PHOSPHOROUS TEST K771477 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 1977. https://www.510kdatabase.net/k771593/ 1977-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k771593-iv-pump-set-for-fat-emulsion-fda-510k.jpg K771593 - I.V. PUMP SET FOR FAT EMULSION K771593 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1977. https://www.510kdatabase.net/k771626/ 1977-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k771626-pacemaker-model-251-fda-510k.jpg K771626 - PACEMAKER MODEL 251 K771626 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Intermedics, Inc.. Cleared Sep 1977. https://www.510kdatabase.net/k771653/ 1977-09-12 monthly 0.5 https://www.510kdatabase.net/og-image/k771653-electronic-stethoscope-fda-510k.jpg K771653 - ELECTRONIC STETHOSCOPE K771653 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: 3M Company. Cleared Sep 1977. https://www.510kdatabase.net/k771329/ 1977-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k771329-disp-ground-pad-pregelled-fda-510k.jpg K771329 - DISP. GROUND PAD PREGELLED K771329 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Sep 1977. https://www.510kdatabase.net/k771330/ 1977-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k771330-disp-ground-plate-fda-510k.jpg K771330 - DISP. GROUND PLATE K771330 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Sep 1977. https://www.510kdatabase.net/k771331/ 1977-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k771331-conductive-electrode-gel-fda-510k.jpg K771331 - CONDUCTIVE ELECTRODE GEL K771331 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Sep 1977. https://www.510kdatabase.net/k771332/ 1977-09-06 monthly 0.5 https://www.510kdatabase.net/og-image/k771332-patient-grounding-cables-fda-510k.jpg K771332 - PATIENT GROUNDING CABLES K771332 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Sep 1977. https://www.510kdatabase.net/k771464/ 1977-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k771464-multistat-iii-glucose-test-fda-510k.jpg K771464 - MULTISTAT III GLUCOSE TEST K771464 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 1977. https://www.510kdatabase.net/k771465/ 1977-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k771465-multistat-iii-lactic-dehydrogenase-fda-510k.jpg K771465 - MULTISTAT III LACTIC DEHYDROGENASE K771465 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 1977. https://www.510kdatabase.net/k771466/ 1977-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k771466-multistat-iii-alanine-aminotransferase-fda-510k.jpg K771466 - MULTISTAT III ALANINE AMINOTRANSFERASE K771466 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 1977. https://www.510kdatabase.net/k771467/ 1977-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k771467-multistat-iii-aspartate-aminotransferase-fda-510k.jpg K771467 - MULTISTAT III ASPARTATE AMINOTRANSFERASE K771467 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 1977. https://www.510kdatabase.net/k771472/ 1977-09-02 monthly 0.5 https://www.510kdatabase.net/og-image/k771472-multistat-iii-triglyceride-test-fda-510k.jpg K771472 - MULTISTAT III TRIGLYCERIDE TEST K771472 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Sep 1977. https://www.510kdatabase.net/k771572/ 1977-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k771572-patient-monitors-models-78701a78702a-fda-510k.jpg K771572 - PATIENT MONITORS MODELS 78701A/78702A K771572 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Aug 1977. https://www.510kdatabase.net/k771602/ 1977-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k771602-myersons-spec-crown-bridge-resin-fda-510k.jpg K771602 - MYERSONS SPEC. CROWN & BRIDGE RESIN K771602 is a FDA 510(k) cleared dental medical device. Manufacturer: Howmedica Corp.. Cleared Aug 1977. https://www.510kdatabase.net/k771279/ 1977-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k771279-head-facilitation-vibrator-bk-5210-fda-510k.jpg K771279 - HEAD FACILITATION VIBRATOR BK-5210 K771279 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Aug 1977. https://www.510kdatabase.net/k771336/ 1977-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k771336-sma-ii-fda-510k.jpg K771336 - SMA II K771336 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Aug 1977. https://www.510kdatabase.net/k771419/ 1977-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k771419-cannula-clamp-fda-510k.jpg K771419 - CANNULA CLAMP K771419 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quinton, Inc.. Cleared Aug 1977. https://www.510kdatabase.net/k771424/ 1977-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k771424-tube-occluding-forceps-fda-510k.jpg K771424 - TUBE OCCLUDING FORCEPS K771424 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Quinton, Inc.. Cleared Aug 1977. https://www.510kdatabase.net/k771463/ 1977-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k771463-aero-pulse-alternating-pres-pump-fda-510k.jpg K771463 - AERO PULSE ALTERNATING PRES. PUMP K771463 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Medline Industries, Inc.. Cleared Aug 1977. https://www.510kdatabase.net/k771519/ 1977-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k771519-specialist-arm-leg-protector-fda-510k.jpg K771519 - SPECIALIST ARM & LEG PROTECTOR K771519 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Aug 1977. https://www.510kdatabase.net/k771598/ 1977-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k771598-patella-prosthesistrail-component-fda-510k.jpg K771598 - PATELLA PROSTHESIS/TRAIL COMPONENT K771598 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Aug 1977. https://www.510kdatabase.net/k771253/ 1977-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k771253-hemox-analyzer-fda-510k.jpg K771253 - HEMOX-ANALYZER K771253 is a FDA 510(k) cleared chemistry medical device. Manufacturer: 3M Company. Cleared Aug 1977. https://www.510kdatabase.net/k771526/ 1977-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k771526-125-i-aldosterone-ria-kit-fda-510k.jpg K771526 - 125 I ALDOSTERONE RIA KIT K771526 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Aug 1977. https://www.510kdatabase.net/k771553/ 1977-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k771553-spiral-scalp-electrode-14499a-fda-510k.jpg K771553 - SPIRAL SCALP ELECTRODE, 14499A K771553 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Aug 1977. https://www.510kdatabase.net/k771559/ 1977-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k771559-hema-tek-ii-slide-stainer-fda-510k.jpg K771559 - HEMA-TEK II SLIDE STAINER K771559 is a FDA 510(k) cleared hematology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Aug 1977. https://www.510kdatabase.net/k771571/ 1977-08-25 monthly 0.5 https://www.510kdatabase.net/og-image/k771571-mobile-x-ray-sys-model-43820a-fda-510k.jpg K771571 - MOBILE X-RAY SYS. MODEL 43820A K771571 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Aug 1977. https://www.510kdatabase.net/k770994/ 1977-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k770994-furnace-autosampler-model-155-fda-510k.jpg K770994 - FURNACE AUTOSAMPLER, MODEL 155 K770994 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Aug 1977. https://www.510kdatabase.net/k771308/ 1977-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k771308-tissue-tek-iii-vip-fda-510k.jpg K771308 - TISSUE-TEK III V.I.P. K771308 is a FDA 510(k) cleared pathology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Aug 1977. https://www.510kdatabase.net/k771384/ 1977-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k771384-autozyme-immobilized-enzyme-coil-fda-510k.jpg K771384 - AUTOZYME IMMOBILIZED ENZYME COIL K771384 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Aug 1977. https://www.510kdatabase.net/k771441/ 1977-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k771441-multistat-iii-cpk-test-fda-510k.jpg K771441 - MULTISTAT III CPK TEST K771441 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Aug 1977. https://www.510kdatabase.net/k771442/ 1977-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k771442-multistat-iii-urea-nitrogen-test-fda-510k.jpg K771442 - MULTISTAT III UREA NITROGEN TEST K771442 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Aug 1977. https://www.510kdatabase.net/k771443/ 1977-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k771443-multistat-iii-creatinine-test-fda-510k.jpg K771443 - MULTISTAT III CREATININE TEST K771443 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Aug 1977. https://www.510kdatabase.net/k771489/ 1977-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k771489-rterial-blood-sampling-kit-fda-510k.jpg K771489 - RTERIAL BLOOD SAMPLING KIT K771489 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1977. https://www.510kdatabase.net/k771497/ 1977-08-22 monthly 0.5 https://www.510kdatabase.net/og-image/k771497-ck-mb-fda-510k.jpg K771497 - CK-MB K771497 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Aug 1977. https://www.510kdatabase.net/k771395/ 1977-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k771395-laparotomy-sponges-sterile-fda-510k.jpg K771395 - LAPAROTOMY SPONGES, STERILE K771395 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Medline Industries, Inc.. Cleared Aug 1977. https://www.510kdatabase.net/k771498/ 1977-08-19 monthly 0.5 https://www.510kdatabase.net/og-image/k771498-continu-flo-y-type-solution-admin-set-fda-510k.jpg K771498 - CONTINU-FLO Y-TYPE SOLUTION ADMIN. SET K771498 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Aug 1977. https://www.510kdatabase.net/k771176/ 1977-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k771176-gothic-arch-tracing-fda-510k.jpg K771176 - GOTHIC ARCH TRACING K771176 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Aug 1977. https://www.510kdatabase.net/k771261/ 1977-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k771261-advanset-fda-510k.jpg K771261 - ADVANSET K771261 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: C.R. Bard, Inc.. Cleared Aug 1977. https://www.510kdatabase.net/k771365/ 1977-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k771365-creatinine-analysis-products-fda-510k.jpg K771365 - CREATININE ANALYSIS PRODUCTS K771365 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1977. https://www.510kdatabase.net/k771440/ 1977-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k771440-macbick-conductive-gel-000907-fda-510k.jpg K771440 - MACBICK CONDUCTIVE GEL - 000907 K771440 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Aug 1977. https://www.510kdatabase.net/k771529/ 1977-08-16 monthly 0.5 https://www.510kdatabase.net/og-image/k771529-peritoneal-introducer-sheath-fda-510k.jpg K771529 - PERITONEAL INTRODUCER & SHEATH K771529 is a FDA 510(k) cleared neurology medical device. Manufacturer: Cordis Corp.. Cleared Aug 1977. https://www.510kdatabase.net/k770244/ 1977-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k770244-auto-differential-cell-counter-system-fda-510k.jpg K770244 - AUTO DIFFERENTIAL CELL COUNTER SYSTEM K770244 is a FDA 510(k) cleared hematology medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1977. https://www.510kdatabase.net/k771074/ 1977-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k771074-nasal-oxygen-cannula-017207-fda-510k.jpg K771074 - NASAL OXYGEN CANNULA, #017207 K771074 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Aug 1977. https://www.510kdatabase.net/k771075/ 1977-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k771075-oxygen-connecting-tube-017205-fda-510k.jpg K771075 - OXYGEN CONNECTING TUBE #017205 K771075 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Aug 1977. https://www.510kdatabase.net/k771098/ 1977-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k771098-blood-grouping-sys-bg-9-fda-510k.jpg K771098 - BLOOD GROUPING SYS., BG-9 K771098 is a FDA 510(k) cleared hematology medical device. Manufacturer: Technicon Instruments Corp.. Cleared Aug 1977. https://www.510kdatabase.net/k771129/ 1977-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k771129-auto-logic-ii-system-fda-510k.jpg K771129 - AUTO-LOGIC II SYSTEM K771129 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1977. https://www.510kdatabase.net/k771151/ 1977-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k771151-artius-system-fda-510k.jpg K771151 - ARTIUS SYSTEM K771151 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: General Electric Co.. Cleared Aug 1977. https://www.510kdatabase.net/k771345/ 1977-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k771345-bichromatic-analyzer-aba-200-fda-510k.jpg K771345 - BICHROMATIC ANALYZER ABA-200 K771345 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1977. https://www.510kdatabase.net/k771360/ 1977-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k771360-ecg-scope-model-7833-fda-510k.jpg K771360 - ECG SCOPE MODEL 7833 K771360 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Aug 1977. https://www.510kdatabase.net/k771361/ 1977-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k771361-physiological-pressure-transducer-1290a-fda-510k.jpg K771361 - PHYSIOLOGICAL PRESSURE TRANSDUCER 1290A K771361 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Aug 1977. https://www.510kdatabase.net/k771385/ 1977-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k771385-2-jet-set-fda-510k.jpg K771385 - 2 JET SET K771385 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1977. https://www.510kdatabase.net/k771408/ 1977-08-04 monthly 0.5 https://www.510kdatabase.net/og-image/k771408-wrought-forged-vitallium-fda-510k.jpg K771408 - WROUGHT (FORGED) VITALLIUM K771408 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Aug 1977. https://www.510kdatabase.net/k771194/ 1977-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k771194-fetalmaternal-alrm-module-21595a-fda-510k.jpg K771194 - FETAL/MATERNAL ALRM MODULE - 21595A K771194 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Aug 1977. https://www.510kdatabase.net/k771195/ 1977-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k771195-fetalmaternal-repeater-21596a-fda-510k.jpg K771195 - FETAL/MATERNAL REPEATER - 21596A K771195 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Aug 1977. https://www.510kdatabase.net/k771196/ 1977-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k771196-marker-generator-modules-21597a-fda-510k.jpg K771196 - MARKER GENERATOR MODULES - 21597A K771196 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Aug 1977. https://www.510kdatabase.net/k771225/ 1977-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k771225-ap-isotrol-a-0140-fda-510k.jpg K771225 - AP ISOTROL, #A 0140 K771225 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Aug 1977. https://www.510kdatabase.net/k771235/ 1977-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k771235-htsh-ria-human-thyroid-hormone-ria-fda-510k.jpg K771235 - HTSH RIA HUMAN THYROID HORMONE RIA K771235 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1977. https://www.510kdatabase.net/k771236/ 1977-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k771236-triobead-125-diagnostic-kit-fda-510k.jpg K771236 - TRIOBEAD-125 DIAGNOSTIC KIT K771236 is a FDA 510(k) cleared immunology medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1977. https://www.510kdatabase.net/k771309/ 1977-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k771309-ria-for-total-thyroxine-fda-510k.jpg K771309 - RIA FOR TOTAL THYROXINE K771309 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1977. https://www.510kdatabase.net/k771321/ 1977-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k771321-hydron-burn-bandage-fda-510k.jpg K771321 - HYDRON BURN BANDAGE K771321 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1977. https://www.510kdatabase.net/k771335/ 1977-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k771335-creatinine-analyzer-2-fda-510k.jpg K771335 - CREATININE ANALYZER 2 K771335 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Aug 1977. https://www.510kdatabase.net/k771370/ 1977-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k771370-icrotaineo-brand-tube-fda-510k.jpg K771370 - ICROTAINEO BRAND TUBE K771370 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1977. https://www.510kdatabase.net/k771383/ 1977-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k771383-alloy-dispos-a-cap-dental-school-cap-fda-510k.jpg K771383 - ALLOY DISPOS-A-CAP DENTAL SCHOOL CAP K771383 is a FDA 510(k) cleared dental medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Aug 1977. https://www.510kdatabase.net/k771396/ 1977-08-03 monthly 0.5 https://www.510kdatabase.net/og-image/k771396-dispenser-mercury-tabletpowder-fda-510k.jpg K771396 - DISPENSER, MERCURY & TABLET/POWDER K771396 is a FDA 510(k) cleared dental medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Aug 1977. https://www.510kdatabase.net/k771228/ 1977-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k771228-lifecare-empty-container-fda-510k.jpg K771228 - LIFECARE EMPTY CONTAINER K771228 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Aug 1977. https://www.510kdatabase.net/k771364/ 1977-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k771364-lube-jel-fda-510k.jpg K771364 - LUBE JEL K771364 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Aug 1977. https://www.510kdatabase.net/k771367/ 1977-08-02 monthly 0.5 https://www.510kdatabase.net/og-image/k771367-choledochoscope-system-fda-510k.jpg K771367 - CHOLEDOCHOSCOPE SYSTEM K771367 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Aug 1977. https://www.510kdatabase.net/k771149/ 1977-07-27 monthly 0.5 https://www.510kdatabase.net/og-image/k771149-endometrial-aspiration-biospy-kit-182341-fda-510k.jpg K771149 - ENDOMETRIAL ASPIRATION BIOSPY KIT 182341 K771149 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jul 1977. https://www.510kdatabase.net/k770690/ 1977-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k770690-mask-vapor-monomer-fda-510k.jpg K770690 - MASK, VAPOR, MONOMER K770690 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jul 1977. https://www.510kdatabase.net/k770877/ 1977-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k770877-data-reduction-system-dp-3000-fda-510k.jpg K770877 - DATA REDUCTION SYSTEM, DP-3000 K770877 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jul 1977. https://www.510kdatabase.net/k771274/ 1977-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k771274-quadriplegic-meat-knife-fda-510k.jpg K771274 - QUADRIPLEGIC MEAT KNIFE K771274 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jul 1977. https://www.510kdatabase.net/k771287/ 1977-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k771287-fingeo-extension-splints-fda-510k.jpg K771287 - FINGEO EXTENSION SPLINTS K771287 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jul 1977. https://www.510kdatabase.net/k771288/ 1977-07-21 monthly 0.5 https://www.510kdatabase.net/og-image/k771288-jamar-dynamometeo-bk-7498-fda-510k.jpg K771288 - JAMAR DYNAMOMETEO BK-7498 K771288 is a FDA 510(k) cleared neurology medical device. Manufacturer: Fred Sammons, Inc.. Cleared Jul 1977. https://www.510kdatabase.net/k770948/ 1977-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k770948-lipoprotein-profiling-system-fda-510k.jpg K770948 - LIPOPROTEIN PROFILING SYSTEM K770948 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jul 1977. https://www.510kdatabase.net/k770982/ 1977-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k770982-united-skin-barrier-fda-510k.jpg K770982 - UNITED SKIN BARRIER K770982 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Howmedica Corp.. Cleared Jul 1977. https://www.510kdatabase.net/k771110/ 1977-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k771110-heritage-special-alloy-fda-510k.jpg K771110 - HERITAGE SPECIAL ALLOY K771110 is a FDA 510(k) cleared dental medical device. Manufacturer: Howmedica Corp.. Cleared Jul 1977. https://www.510kdatabase.net/k771179/ 1977-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k771179-biobond-master-stain-and-glaze-kit-fda-510k.jpg K771179 - BIOBOND MASTER STAIN AND GLAZE KIT K771179 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jul 1977. https://www.510kdatabase.net/k771186/ 1977-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k771186-micro-bi-polar-forceps-39-200-fda-510k.jpg K771186 - MICRO BI-POLAR FORCEPS #39-200 K771186 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Jul 1977. https://www.510kdatabase.net/k771233/ 1977-07-15 monthly 0.5 https://www.510kdatabase.net/og-image/k771233-phenytoin-analytical-test-packs-fda-510k.jpg K771233 - PHENYTOIN ANALYTICAL TEST PACKS K771233 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Jul 1977. https://www.510kdatabase.net/k770902/ 1977-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k770902-colorimetric-determ-socitrate-dehydro-fda-510k.jpg K770902 - COLORIMETRIC DETERM. SOCITRATE DEHYDRO. K770902 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Jul 1977. https://www.510kdatabase.net/k771135/ 1977-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k771135-quantimune-neonatal-thyroxine-ria-fda-510k.jpg K771135 - QUANTIMUNE NEONATAL & THYROXINE RIA K771135 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Jul 1977. https://www.510kdatabase.net/k771223/ 1977-07-14 monthly 0.5 https://www.510kdatabase.net/og-image/k771223-gray-tone-imaging-film-fda-510k.jpg K771223 - GRAY TONE IMAGING FILM K771223 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared Jul 1977. https://www.510kdatabase.net/k770774/ 1977-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k770774-lytetek-system-fda-510k.jpg K770774 - LYTETEK SYSTEM K770774 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jul 1977. https://www.510kdatabase.net/k770822/ 1977-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k770822-a-gent-albumin-fda-510k.jpg K770822 - A-GENT ALBUMIN K770822 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Abbott Laboratories. Cleared Jul 1977. https://www.510kdatabase.net/k770825/ 1977-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k770825-spectrophotometers3435363600-fda-510k.jpg K770825 - SPECTROPHOTOMETERS,34,35,36,3600 K770825 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jul 1977. https://www.510kdatabase.net/k770980/ 1977-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k770980-ematology-diluent-reservoir-closure-fda-510k.jpg K770980 - EMATOLOGY DILUENT RESERVOIR CLOSURE K770980 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jul 1977. https://www.510kdatabase.net/k771187/ 1977-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k771187-dermahook-382-805-fda-510k.jpg K771187 - DERMAHOOK #382-805 K771187 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Jul 1977. https://www.510kdatabase.net/k771189/ 1977-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k771189-hot-temp-cautery-fda-510k.jpg K771189 - HOT TEMP CAUTERY K771189 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Edward Weck, Inc.. Cleared Jul 1977. https://www.510kdatabase.net/k771190/ 1977-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k771190-abramson-trachea-hook-retractor-fda-510k.jpg K771190 - ABRAMSON TRACHEA HOOK & RETRACTOR K771190 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Jul 1977. https://www.510kdatabase.net/k771191/ 1977-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k771191-heiss-retractor-fda-510k.jpg K771191 - HEISS RETRACTOR K771191 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Jul 1977. https://www.510kdatabase.net/k771192/ 1977-07-11 monthly 0.5 https://www.510kdatabase.net/og-image/k771192-lowman-bone-forcep-fda-510k.jpg K771192 - LOWMAN BONE FORCEP K771192 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Jul 1977. https://www.510kdatabase.net/k770750/ 1977-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k770750-reagent-kit-enzymatic-amylase-fda-510k.jpg K770750 - REAGENT KIT, ENZYMATIC AMYLASE K770750 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jul 1977. https://www.510kdatabase.net/k770946/ 1977-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k770946-record-model-702-il-fda-510k.jpg K770946 - RECORD, MODEL 702, I.L. K770946 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jul 1977. https://www.510kdatabase.net/k771035/ 1977-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k771035-culture-test-for-neisseria-gonorrhoeae-fda-510k.jpg K771035 - CULTURE TEST FOR NEISSERIA GONORRHOEAE K771035 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Jul 1977. https://www.510kdatabase.net/k771061/ 1977-07-05 monthly 0.5 https://www.510kdatabase.net/og-image/k771061-oduflex-aerosol-set-fda-510k.jpg K771061 - ODUFLEX AEROSOL SET K771061 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jul 1977. https://www.510kdatabase.net/k771058/ 1977-07-01 monthly 0.5 https://www.510kdatabase.net/og-image/k771058-eptone-back-up-broth-vacutainer-fda-510k.jpg K771058 - EPTONE BACK-UP BROTH, VACUTAINER K771058 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jul 1977. https://www.510kdatabase.net/k770826/ 1977-06-28 monthly 0.5 https://www.510kdatabase.net/og-image/k770826-pouch-ileostomy-odorproof-featherlite-fda-510k.jpg K770826 - POUCH, ILEOSTOMY, ODORPROOF, FEATHERLITE K770826 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Howmedica Corp.. Cleared Jun 1977. https://www.510kdatabase.net/k770228/ 1977-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k770228-aqueous-phblood-gas-controls-fda-510k.jpg K770228 - AQUEOUS PH/BLOOD GAS CONTROLS K770228 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jun 1977. https://www.510kdatabase.net/k770868/ 1977-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k770868-catheter-polyurethane-wstylet-fda-510k.jpg K770868 - CATHETER, POLYURETHANE, W/STYLET K770868 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1977. https://www.510kdatabase.net/k771047/ 1977-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k771047-quanta-mate-vitamin-b-12folate-ra-fda-510k.jpg K771047 - QUANTA-MATE VITAMIN B-12/FOLATE RA K771047 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Jun 1977. https://www.510kdatabase.net/k771072/ 1977-06-27 monthly 0.5 https://www.510kdatabase.net/og-image/k771072-inserteo-meta-phalthumb-carpo-meta-fda-510k.jpg K771072 - INSERTEO, META.-PHAL.&THUMB CARPO-META K771072 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jun 1977. https://www.510kdatabase.net/k770645/ 1977-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k770645-spectrophotometer-model-751-fda-510k.jpg K770645 - SPECTROPHOTOMETER, MODEL 751 K770645 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jun 1977. https://www.510kdatabase.net/k770654/ 1977-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k770654-un-uv-delta-test-assay-fda-510k.jpg K770654 - UN, UV DELTA TEST ASSAY K770654 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jun 1977. https://www.510kdatabase.net/k770655/ 1977-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k770655-latelet-determibation-kit-ul-800-fda-510k.jpg K770655 - LATELET DETERMIBATION KIT, UL 800 K770655 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jun 1977. https://www.510kdatabase.net/k770660/ 1977-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k770660-analyzer-centrifugal-il-multistat-iii-fda-510k.jpg K770660 - ANALYZER, CENTRIFUGAL, IL MULTISTAT III K770660 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jun 1977. https://www.510kdatabase.net/k770731/ 1977-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k770731-eagent-system-cortisol-aria-fda-510k.jpg K770731 - EAGENT SYSTEM, CORTISOL, ARIA K770731 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jun 1977. https://www.510kdatabase.net/k770733/ 1977-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k770733-reagent-system-thyroxine-aria-fda-510k.jpg K770733 - REAGENT SYSTEM, THYROXINE, ARIA K770733 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jun 1977. https://www.510kdatabase.net/k770743/ 1977-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k770743-soluset-for-iv-fat-emulsion-fda-510k.jpg K770743 - SOLUSET FOR IV FAT EMULSION K770743 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1977. https://www.510kdatabase.net/k771051/ 1977-06-24 monthly 0.5 https://www.510kdatabase.net/og-image/k771051-c-arm-x-ray-system-fda-510k.jpg K771051 - C-ARM X-RAY SYSTEM K771051 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jun 1977. https://www.510kdatabase.net/k770732/ 1977-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k770732-reagent-system-progesterone-aria-fda-510k.jpg K770732 - REAGENT SYSTEM, PROGESTERONE, ARIA K770732 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jun 1977. https://www.510kdatabase.net/k770919/ 1977-06-22 monthly 0.5 https://www.510kdatabase.net/og-image/k770919-phenobarbital-analytical-test-packs-fda-510k.jpg K770919 - PHENOBARBITAL ANALYTICAL TEST PACKS K770919 is a FDA 510(k) cleared toxicology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Jun 1977. https://www.510kdatabase.net/k770498/ 1977-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k770498-preserve-lubricant-code-no-434035-fda-510k.jpg K770498 - PRESERVE LUBRICANT CODE NO. 43=4035 K770498 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Jun 1977. https://www.510kdatabase.net/k770523/ 1977-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k770523-needle-biopsy-boyd-lung-fda-510k.jpg K770523 - NEEDLE, BIOPSY, BOYD, LUNG K770523 is a FDA 510(k) cleared pathology medical device. Manufacturer: Cook, Inc.. Cleared Jun 1977. https://www.510kdatabase.net/k770749/ 1977-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k770749-toothbrush-reach-fda-510k.jpg K770749 - TOOTHBRUSH, REACH K770749 is a FDA 510(k) cleared dental medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jun 1977. https://www.510kdatabase.net/k770951/ 1977-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k770951-cardiac-pacers-wnarrow-pulse-width-fda-510k.jpg K770951 - CARDIAC PACERS W/NARROW PULSE WIDTH K770951 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Jun 1977. https://www.510kdatabase.net/k771026/ 1977-06-20 monthly 0.5 https://www.510kdatabase.net/og-image/k771026-huang-vein-holder-21-8011-fda-510k.jpg K771026 - HUANG VEIN HOLDER, #21-8011 K771026 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Jun 1977. https://www.510kdatabase.net/k770577/ 1977-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k770577-deter-of-phosphohexose-isomerase-fda-510k.jpg K770577 - DETER. OF PHOSPHOHEXOSE ISOMERASE K770577 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Jun 1977. https://www.510kdatabase.net/k771003/ 1977-06-17 monthly 0.5 https://www.510kdatabase.net/og-image/k771003-lieberman-polack-double-corneal-forceps-fda-510k.jpg K771003 - LIEBERMAN POLACK DOUBLE CORNEAL FORCEPS K771003 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Edward Weck, Inc.. Cleared Jun 1977. https://www.510kdatabase.net/k770362/ 1977-06-15 monthly 0.5 https://www.510kdatabase.net/og-image/k770362-tape-dermicel-cloth-fda-510k.jpg K770362 - TAPE, DERMICEL, CLOTH K770362 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jun 1977. https://www.510kdatabase.net/k770648/ 1977-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k770648-quantimune-t-3-ria-fda-510k.jpg K770648 - QUANTIMUNE T-3 RIA K770648 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bio-Rad. Cleared Jun 1977. https://www.510kdatabase.net/k770843/ 1977-06-14 monthly 0.5 https://www.510kdatabase.net/og-image/k770843-iv-pump-filterset-universal-fda-510k.jpg K770843 - IV PUMP FILTERSET, UNIVERSAL K770843 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Jun 1977. https://www.510kdatabase.net/k770410/ 1977-06-09 monthly 0.5 https://www.510kdatabase.net/og-image/k770410-bandage-compress-2-3-4-fda-510k.jpg K770410 - BANDAGE COMPRESS 2, 3, 4 K770410 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jun 1977. https://www.510kdatabase.net/k770495/ 1977-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k770495-quanti-colori-det-of-serum-iron-fda-510k.jpg K770495 - QUANTI. COLORI. DET. OF SERUM IRON K770495 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Jun 1977. https://www.510kdatabase.net/k770570/ 1977-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k770570-calciummagnesium-analyzer-fda-510k.jpg K770570 - CALCIUM/MAGNESIUM ANALYZER K770570 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jun 1977. https://www.510kdatabase.net/k770763/ 1977-06-08 monthly 0.5 https://www.510kdatabase.net/og-image/k770763-burette-set-2c0132-fda-510k.jpg K770763 - BURETTE SET, 2C0132 K770763 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Jun 1977. https://www.510kdatabase.net/k770533/ 1977-06-07 monthly 0.5 https://www.510kdatabase.net/og-image/k770533-band-aid-brand-adhes-band-sheer-strips-fda-510k.jpg K770533 - BAND-AID BRAND ADHES. BAND.-SHEER STRIPS K770533 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jun 1977. https://www.510kdatabase.net/k770519/ 1977-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k770519-reagent-system-153-uv-fda-510k.jpg K770519 - REAGENT SYSTEM 153-UV K770519 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Jun 1977. https://www.510kdatabase.net/k770932/ 1977-06-03 monthly 0.5 https://www.510kdatabase.net/og-image/k770932-geramco-low-temp-glaze-fda-510k.jpg K770932 - GERAMCO LOW TEMP GLAZE K770932 is a FDA 510(k) cleared dental medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jun 1977. https://www.510kdatabase.net/k770465/ 1977-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k770465-ria-120-and-estriol-reagent-system-fda-510k.jpg K770465 - RIA-120 AND ESTRIOL REAGENT SYSTEM K770465 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jun 1977. https://www.510kdatabase.net/k770929/ 1977-06-02 monthly 0.5 https://www.510kdatabase.net/og-image/k770929-bandages-spec-x-tra-hard-or-plaster-fda-510k.jpg K770929 - BANDAGES, SPEC. X-TRA HARD OR PLASTER K770929 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jun 1977. https://www.510kdatabase.net/k770913/ 1977-06-01 monthly 0.5 https://www.510kdatabase.net/og-image/k770913-urological-biopsy-brush-set-fda-510k.jpg K770913 - UROLOGICAL BIOPSY BRUSH SET K770913 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook, Inc.. Cleared Jun 1977. https://www.510kdatabase.net/k770744/ 1977-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k770744-iv-set-that-reverts-to-kvo-rate-fda-510k.jpg K770744 - IV SET THAT REVERTS TO KVO RATE K770744 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared May 1977. https://www.510kdatabase.net/k770837/ 1977-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k770837-screen-fine-lanes-kodak-fda-510k.jpg K770837 - SCREEN, FINE, LANES, KODAK K770837 is a FDA 510(k) cleared radiology medical device. Manufacturer: Eastman Kodak Company. Cleared May 1977. https://www.510kdatabase.net/k770855/ 1977-05-26 monthly 0.5 https://www.510kdatabase.net/og-image/k770855-synerview-model-6478-fda-510k.jpg K770855 - SYNERVIEW MODEL 6478 K770855 is a FDA 510(k) cleared radiology medical device. Manufacturer: Philips Medical Systems (Cleveland), Inc.. Cleared May 1977. https://www.510kdatabase.net/k770647/ 1977-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k770647-electrosurgical-grounding-cable-fda-510k.jpg K770647 - ELECTROSURGICAL GROUNDING CABLE K770647 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared May 1977. https://www.510kdatabase.net/k770856/ 1977-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k770856-prosthesis-trapezium-trapezium-trial-fda-510k.jpg K770856 - PROSTHESIS, TRAPEZIUM & TRAPEZIUM TRIAL K770856 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared May 1977. https://www.510kdatabase.net/k770908/ 1977-05-23 monthly 0.5 https://www.510kdatabase.net/og-image/k770908-prosthesis-hip-trapezoidal-28-fda-510k.jpg K770908 - PROSTHESIS, HIP, TRAPEZOIDAL-28 K770908 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Zimmer, Inc.. Cleared May 1977. https://www.510kdatabase.net/k770659/ 1977-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k770659-rialyze-hpl-ria-fda-510k.jpg K770659 - RIALYZE HPL (RIA) K770659 is a FDA 510(k) cleared immunology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared May 1977. https://www.510kdatabase.net/k770697/ 1977-05-20 monthly 0.5 https://www.510kdatabase.net/og-image/k770697-colposcope-system-fda-510k.jpg K770697 - COLPOSCOPE SYSTEM K770697 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared May 1977. https://www.510kdatabase.net/k770786/ 1977-05-18 monthly 0.5 https://www.510kdatabase.net/og-image/k770786-splints-fingertoe-fda-510k.jpg K770786 - SPLINTS, FINGER/TOE K770786 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Depuy, Inc.. Cleared May 1977. https://www.510kdatabase.net/k770734/ 1977-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k770734-dialyzer-fiber-hollow-fda-510k.jpg K770734 - DIALYZER, FIBER, HOLLOW K770734 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared May 1977. https://www.510kdatabase.net/k770735/ 1977-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k770735-dialyzer-coil-cd-lsa-5m1765-fda-510k.jpg K770735 - DIALYZER, COIL, CD, LSA, 5M1765 K770735 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared May 1977. https://www.510kdatabase.net/k770753/ 1977-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k770753-porta-camera-iic-fda-510k.jpg K770753 - PORTA CAMERA IIC K770753 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared May 1977. https://www.510kdatabase.net/k770762/ 1977-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k770762-bag-urinary-drainage-2d9013-fda-510k.jpg K770762 - BAG, URINARY, DRAINAGE, 2D9013 K770762 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared May 1977. https://www.510kdatabase.net/k770783/ 1977-05-10 monthly 0.5 https://www.510kdatabase.net/og-image/k770783-film-processor-automatic-fda-510k.jpg K770783 - FILM PROCESSOR, AUTOMATIC K770783 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared May 1977. https://www.510kdatabase.net/k770666/ 1977-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k770666-hemalog-890-fda-510k.jpg K770666 - HEMALOG 8/90 K770666 is a FDA 510(k) cleared hematology medical device. Manufacturer: Technicon Instruments Corp.. Cleared May 1977. https://www.510kdatabase.net/k770760/ 1977-05-06 monthly 0.5 https://www.510kdatabase.net/og-image/k770760-monitor-portable-patient-ge-fda-510k.jpg K770760 - MONITOR, PORTABLE, PATIENT, G.E. K770760 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: General Electric Co.. Cleared May 1977. https://www.510kdatabase.net/k770390/ 1977-05-03 monthly 0.5 https://www.510kdatabase.net/og-image/k770390-urinalysis-proficiency-fda-510k.jpg K770390 - URINALYSIS PROFICIENCY K770390 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared May 1977. https://www.510kdatabase.net/k770518/ 1977-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k770518-piggyback-venoset-w022-filter-fda-510k.jpg K770518 - PIGGYBACK VENOSET W/0.22 FILTER K770518 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1977. https://www.510kdatabase.net/k770759/ 1977-04-29 monthly 0.5 https://www.510kdatabase.net/og-image/k770759-hook-holler-fda-510k.jpg K770759 - HOOK HOLLER K770759 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Depuy, Inc.. Cleared Apr 1977. https://www.510kdatabase.net/k770474/ 1977-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k770474-thyroscreen-tm-t4-diagnostic-kit-fda-510k.jpg K770474 - THYROSCREEN TM T4 DIAGNOSTIC KIT K770474 is a FDA 510(k) cleared immunology medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1977. https://www.510kdatabase.net/k770646/ 1977-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k770646-electrosurgical-patient-grounding-pad-fda-510k.jpg K770646 - ELECTROSURGICAL PATIENT GROUNDING PAD K770646 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 1977. https://www.510kdatabase.net/k770729/ 1977-04-28 monthly 0.5 https://www.510kdatabase.net/og-image/k770729-pyeloscope-system-fda-510k.jpg K770729 - PYELOSCOPE SYSTEM K770729 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Apr 1977. https://www.510kdatabase.net/k770400/ 1977-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k770400-reagent-amylase-lipase-fda-510k.jpg K770400 - REAGENT, AMYLASE LIPASE K770400 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1977. https://www.510kdatabase.net/k770401/ 1977-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k770401-ldhnadhldhnadh-nad-nad-diaphorase-fda-510k.jpg K770401 - LDH/NADH,LDH/NADH, NAD & NAD DIAPHORASE K770401 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1977. https://www.510kdatabase.net/k770710/ 1977-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k770710-needle-spray-fda-510k.jpg K770710 - NEEDLE, SPRAY K770710 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Apr 1977. https://www.510kdatabase.net/k770711/ 1977-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k770711-trocar-sleeve-system-65mm-to-50mm-fda-510k.jpg K770711 - TROCAR SLEEVE SYSTEM, 6.5MM TO 5.0MM K770711 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Apr 1977. https://www.510kdatabase.net/k770712/ 1977-04-26 monthly 0.5 https://www.510kdatabase.net/og-image/k770712-trocar-sleeve-system-4mm-to-34mm-fda-510k.jpg K770712 - TROCAR SLEEVE SYSTEM 4MM TO 3.4MM K770712 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Apr 1977. https://www.510kdatabase.net/k770347/ 1977-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k770347-meter-ph-digital-model-3560-fda-510k.jpg K770347 - METER, PH, DIGITAL, MODEL 3560 K770347 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Apr 1977. https://www.510kdatabase.net/k770364/ 1977-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k770364-aca-lipase-analytical-test-pack-fda-510k.jpg K770364 - ACA LIPASE ANALYTICAL TEST PACK K770364 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Apr 1977. https://www.510kdatabase.net/k770380/ 1977-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k770380-chemistry-control-low-high-tqc-tm-fda-510k.jpg K770380 - CHEMISTRY CONTROL-LOW & HIGH TQC TM K770380 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Apr 1977. https://www.510kdatabase.net/k770535/ 1977-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k770535-c-dak-3500-fda-510k.jpg K770535 - C-DAK 3500 K770535 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Apr 1977. https://www.510kdatabase.net/k770572/ 1977-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k770572-dp-5000-data-reduction-system-fda-510k.jpg K770572 - DP-5000 DATA REDUCTION SYSTEM K770572 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Apr 1977. https://www.510kdatabase.net/k770602/ 1977-04-15 monthly 0.5 https://www.510kdatabase.net/og-image/k770602-valve-ascites-laveen-fda-510k.jpg K770602 - VALVE, ASCITES, LAVEEN K770602 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1977. https://www.510kdatabase.net/k770651/ 1977-04-14 monthly 0.5 https://www.510kdatabase.net/og-image/k770651-retractors-hooks-abramson-fda-510k.jpg K770651 - RETRACTORS & HOOKS, ABRAMSON K770651 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Apr 1977. https://www.510kdatabase.net/k770352/ 1977-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k770352-meter-iv-ph-model-expandomatic-fda-510k.jpg K770352 - METER, IV PH, MODEL EXPANDOMATIC K770352 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Apr 1977. https://www.510kdatabase.net/k770363/ 1977-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k770363-aca-ammonia-analytical-test-pack-fda-510k.jpg K770363 - ACA AMMONIA ANALYTICAL TEST PACK K770363 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Apr 1977. https://www.510kdatabase.net/k770384/ 1977-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k770384-mnitrol-hemotol-ref-and-control-fda-510k.jpg K770384 - MNITROL HEMOTOL. REF. AND CONTROL K770384 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1977. https://www.510kdatabase.net/k770385/ 1977-04-08 monthly 0.5 https://www.510kdatabase.net/og-image/k770385-latelet-determin-kit-cat-no-2521-fda-510k.jpg K770385 - LATELET DETERMIN. KIT, CAT NO. 2521 K770385 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Apr 1977. https://www.510kdatabase.net/k770514/ 1977-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k770514-sterilizer-wrap-fda-510k.jpg K770514 - STERILIZER WRAP K770514 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Apr 1977. https://www.510kdatabase.net/k770615/ 1977-04-07 monthly 0.5 https://www.510kdatabase.net/og-image/k770615-1304a-x-y-display-introduction-fda-510k.jpg K770615 - 1304A X-Y DISPLAY INTRODUCTION K770615 is a FDA 510(k) cleared radiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Apr 1977. https://www.510kdatabase.net/k770179/ 1977-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k770179-cardiac-catheterization-lab-monitor-sys-fda-510k.jpg K770179 - CARDIAC CATHETERIZATION LAB MONITOR SYS K770179 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: General Electric Co.. Cleared Apr 1977. https://www.510kdatabase.net/k770201/ 1977-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k770201-t3-ria-peg-diagnostic-kit-fda-510k.jpg K770201 - T3 RIA (PEG) DIAGNOSTIC KIT K770201 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Abbott Laboratories. Cleared Apr 1977. https://www.510kdatabase.net/k770351/ 1977-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k770351-meter-iv-ph-model-zeromatic-fda-510k.jpg K770351 - METER, IV PH, MODEL ZEROMATIC K770351 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Apr 1977. https://www.510kdatabase.net/k770419/ 1977-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k770419-centurion-fda-510k.jpg K770419 - CENTURION K770419 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Apr 1977. https://www.510kdatabase.net/k770574/ 1977-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k770574-cronex-quanta-iii-intensifying-screens-fda-510k.jpg K770574 - CRONEX QUANTA III INTENSIFYING SCREENS K770574 is a FDA 510(k) cleared radiology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Apr 1977. https://www.510kdatabase.net/k770599/ 1977-04-05 monthly 0.5 https://www.510kdatabase.net/og-image/k770599-nuva-lite-ii-photo-cure-unit-fda-510k.jpg K770599 - NUVA-LITE II PHOTO-CURE UNIT K770599 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Apr 1977. https://www.510kdatabase.net/k770478/ 1977-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k770478-adapter-cordis-fda-510k.jpg K770478 - ADAPTER, CORDIS K770478 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Mar 1977. https://www.510kdatabase.net/k770503/ 1977-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k770503-louisville-clamp-product-65-172-fda-510k.jpg K770503 - LOUISVILLE CLAMP PRODUCT #65-172 K770503 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Edward Weck, Inc.. Cleared Mar 1977. https://www.510kdatabase.net/k770522/ 1977-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k770522-catheter-gruntzig-ballon-fda-510k.jpg K770522 - CATHETER, GRUNTZIG, BALLON K770522 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cook, Inc.. Cleared Mar 1977. https://www.510kdatabase.net/k770571/ 1977-03-30 monthly 0.5 https://www.510kdatabase.net/og-image/k770571-tray-anesthesia-epidural-continuous-fda-510k.jpg K770571 - TRAY, ANESTHESIA, EPIDURAL, CONTINUOUS K770571 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Mar 1977. https://www.510kdatabase.net/k761289/ 1977-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k761289-ultra-logic-800-hematology-ana-ul-800-fda-510k.jpg K761289 - ULTRA LOGIC 800 HEMATOLOGY ANA. (UL-800) K761289 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1977. https://www.510kdatabase.net/k770214/ 1977-03-28 monthly 0.5 https://www.510kdatabase.net/og-image/k770214-temp-pervenous-lead-wremote-anode-fda-510k.jpg K770214 - TEMP. PERVENOUS LEAD W/REMOTE ANODE K770214 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Cordis Corp.. Cleared Mar 1977. https://www.510kdatabase.net/k770471/ 1977-03-24 monthly 0.5 https://www.510kdatabase.net/og-image/k770471-kerboull-charnley-cup-special-model-fda-510k.jpg K770471 - KERBOULL-CHARNLEY CUP SPECIAL MODEL K770471 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Mar 1977. https://www.510kdatabase.net/k760997/ 1977-03-23 monthly 0.5 https://www.510kdatabase.net/og-image/k760997-under-bottocks-drape-fda-510k.jpg K760997 - UNDER BOTTOCKS DRAPE K760997 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Mar 1977. https://www.510kdatabase.net/k761306/ 1977-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k761306-clinilab-automated-urinalysis-system-fda-510k.jpg K761306 - CLINILAB AUTOMATED URINALYSIS SYSTEM K761306 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Mar 1977. https://www.510kdatabase.net/k761310/ 1977-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k761310-mega-diastix-fda-510k.jpg K761310 - MEGA-DIASTIX K761310 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Mar 1977. https://www.510kdatabase.net/k761329/ 1977-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k761329-mt-ii-system-serum-albumin-fda-510k.jpg K761329 - MT II SYSTEM - SERUM ALBUMIN K761329 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Mar 1977. https://www.510kdatabase.net/k770386/ 1977-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k770386-latelet-control-normal-abnormal-fda-510k.jpg K770386 - LATELET, CONTROL, NORMAL & ABNORMAL K770386 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1977. https://www.510kdatabase.net/k770493/ 1977-03-21 monthly 0.5 https://www.510kdatabase.net/og-image/k770493-travacath-fda-510k.jpg K770493 - TRAVACATH K770493 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Mar 1977. https://www.510kdatabase.net/k770472/ 1977-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k770472-prosthesis-vidal-total-hip-fda-510k.jpg K770472 - PROSTHESIS, VIDAL TOTAL HIP K770472 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Mar 1977. https://www.510kdatabase.net/k770473/ 1977-03-17 monthly 0.5 https://www.510kdatabase.net/og-image/k770473-lagrange-letournel-total-hip-femoral-fda-510k.jpg K770473 - LAGRANGE LETOURNEL TOTAL HIP FEMORAL K770473 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Mar 1977. https://www.510kdatabase.net/k770015/ 1977-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k770015-noseclip-for-resp-care-pulmon-func-fda-510k.jpg K770015 - NOSECLIP FOR RESP. CARE & PULMON. FUNC. K770015 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1977. https://www.510kdatabase.net/k770271/ 1977-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k770271-chemstrip-g-fda-510k.jpg K770271 - CHEMSTRIP G K770271 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Mar 1977. https://www.510kdatabase.net/k770403/ 1977-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k770403-catheter-thru-needle-device-fda-510k.jpg K770403 - CATHETER-THRU-NEEDLE DEVICE K770403 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1977. https://www.510kdatabase.net/k770404/ 1977-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k770404-obturator-fda-510k.jpg K770404 - OBTURATOR K770404 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1977. https://www.510kdatabase.net/k770475/ 1977-03-16 monthly 0.5 https://www.510kdatabase.net/og-image/k770475-pressure-transducer-isolater-code-5ml6l2-fda-510k.jpg K770475 - PRESSURE TRANSDUCER ISOLATER CODE 5ML6L2 K770475 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Mar 1977. https://www.510kdatabase.net/k770182/ 1977-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k770182-022um-filterset-wy-injection-site-fda-510k.jpg K770182 - 0.22/UM FILTERSET W/Y-INJECTION SITE K770182 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Mar 1977. https://www.510kdatabase.net/k770408/ 1977-03-15 monthly 0.5 https://www.510kdatabase.net/og-image/k770408-karaya-gum-powder-ostomy-fda-510k.jpg K770408 - KARAYA GUM POWDER, OSTOMY K770408 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Howmedica Corp.. Cleared Mar 1977. https://www.510kdatabase.net/k770185/ 1977-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k770185-rh-control-diluent-fda-510k.jpg K770185 - RH CONTROL DILUENT K770185 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1977. https://www.510kdatabase.net/k770389/ 1977-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k770389-lens-set-mentor-trial-fda-510k.jpg K770389 - LENS SET, MENTOR TRIAL K770389 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Mar 1977. https://www.510kdatabase.net/k770420/ 1977-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k770420-forceps-ankle-inserting-con-axial-fda-510k.jpg K770420 - FORCEPS, ANKLE INSERTING, CON-AXIAL K770420 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Mar 1977. https://www.510kdatabase.net/k770421/ 1977-03-14 monthly 0.5 https://www.510kdatabase.net/og-image/k770421-components-ankle-trial-con-axial-fda-510k.jpg K770421 - COMPONENTS, ANKLE, TRIAL, CON-AXIAL K770421 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Mar 1977. https://www.510kdatabase.net/k770405/ 1977-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k770405-overload-warning-device-fda-510k.jpg K770405 - OVERLOAD WARNING DEVICE K770405 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Synthes (Usa). Cleared Mar 1977. https://www.510kdatabase.net/k770441/ 1977-03-10 monthly 0.5 https://www.510kdatabase.net/og-image/k770441-gar-columbia-w5-horse-blood-fda-510k.jpg K770441 - GAR, COLUMBIA, W/5% HORSE BLOOD K770441 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1977. https://www.510kdatabase.net/k770081/ 1977-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k770081-band-aid-brand-of-adhesive-bandages-fda-510k.jpg K770081 - BAND-AID BRAND OF ADHESIVE BANDAGES K770081 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Mar 1977. https://www.510kdatabase.net/k770378/ 1977-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k770378-laparoscope-fiber-light-palmer-jacobs-fda-510k.jpg K770378 - LAPAROSCOPE, FIBER LIGHT, PALMER-JACOBS K770378 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Mar 1977. https://www.510kdatabase.net/k770379/ 1977-03-09 monthly 0.5 https://www.510kdatabase.net/og-image/k770379-trocar-sleeve-system-fda-510k.jpg K770379 - TROCAR SLEEVE SYSTEM K770379 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Mar 1977. https://www.510kdatabase.net/k770348/ 1977-03-08 monthly 0.5 https://www.510kdatabase.net/og-image/k770348-trocar-sleeve-system-extended-fda-510k.jpg K770348 - TROCAR SLEEVE SYSTEM, EXTENDED K770348 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Mar 1977. https://www.510kdatabase.net/k760942/ 1977-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k760942-gentasak-fda-510k.jpg K760942 - GENTASAK K760942 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Mar 1977. https://www.510kdatabase.net/k761062/ 1977-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k761062-histo-tek-w-automatic-coverslipper-fda-510k.jpg K761062 - HISTO-TEK W/ AUTOMATIC COVERSLIPPER K761062 is a FDA 510(k) cleared pathology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Mar 1977. https://www.510kdatabase.net/k761340/ 1977-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k761340-ostomy-karaya-gum-powder-fda-510k.jpg K761340 - OSTOMY KARAYA GUM POWDER K761340 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Howmedica Corp.. Cleared Mar 1977. https://www.510kdatabase.net/k770349/ 1977-03-07 monthly 0.5 https://www.510kdatabase.net/og-image/k770349-rigid-teaching-attachment-fda-510k.jpg K770349 - RIGID TEACHING ATTACHMENT K770349 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Richard Wolf Medical Instruments Corp.. Cleared Mar 1977. https://www.510kdatabase.net/k761157/ 1977-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k761157-aminoglycoside-125i-ria-kit-fda-510k.jpg K761157 - AMINOGLYCOSIDE (125I) RIA KIT K761157 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Mar 1977. https://www.510kdatabase.net/k770272/ 1977-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k770272-uric-acid-test-bmc-autoflo-fda-510k.jpg K770272 - URIC ACID TEST, BMC AUTOFLO K770272 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Mar 1977. https://www.510kdatabase.net/k770273/ 1977-03-01 monthly 0.5 https://www.510kdatabase.net/og-image/k770273-test-ammonia-bmc-reagentset-fda-510k.jpg K770273 - TEST, AMMONIA, BMC REAGENTSET K770273 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Mar 1977. https://www.510kdatabase.net/k770022/ 1977-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k770022-monitor-neonatal-model-78261a-fda-510k.jpg K770022 - MONITOR, NEONATAL, MODEL 78261A K770022 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Feb 1977. https://www.510kdatabase.net/k770023/ 1977-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k770023-monitor-neonate-model-78213a-fda-510k.jpg K770023 - MONITOR, NEONATE, MODEL 78213A K770023 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Feb 1977. https://www.510kdatabase.net/k770024/ 1977-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k770024-monitor-neonatal-model-78260a-fda-510k.jpg K770024 - MONITOR, NEONATAL, MODEL 78260A K770024 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Feb 1977. https://www.510kdatabase.net/k770095/ 1977-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k770095-platelet-control-normal-abnormal-fda-510k.jpg K770095 - PLATELET CONTROL, NORMAL & ABNORMAL K770095 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Feb 1977. https://www.510kdatabase.net/k770339/ 1977-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k770339-bandage-plastic-sheer-fda-510k.jpg K770339 - BANDAGE, PLASTIC & SHEER K770339 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Feb 1977. https://www.510kdatabase.net/k770340/ 1977-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k770340-bandages-plaster-of-paris-splints-fda-510k.jpg K770340 - BANDAGES, PLASTER OF PARIS & SPLINTS K770340 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Feb 1977. https://www.510kdatabase.net/k770343/ 1977-02-28 monthly 0.5 https://www.510kdatabase.net/og-image/k770343-maxicamera-ii-fda-510k.jpg K770343 - MAXICAMERA II K770343 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Feb 1977. https://www.510kdatabase.net/k770365/ 1977-02-24 monthly 0.5 https://www.510kdatabase.net/og-image/k770365-radioimmunoassay-digoxin-test-in-vitro-fda-510k.jpg K770365 - RADIOIMMUNOASSAY DIGOXIN TEST, IN VITRO K770365 is a FDA 510(k) cleared immunology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Feb 1977. https://www.510kdatabase.net/k770200/ 1977-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k770200-gohpo-glucose-reagent-trinder-fda-510k.jpg K770200 - GO/HPO-GLUCOSE REAGENT (TRINDER) K770200 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Feb 1977. https://www.510kdatabase.net/k770262/ 1977-02-23 monthly 0.5 https://www.510kdatabase.net/og-image/k770262-glucose-hexokinase-delta-test-assay-fda-510k.jpg K770262 - GLUCOSE (HEXOKINASE) DELTA TEST ASSAY K770262 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Feb 1977. https://www.510kdatabase.net/k770207/ 1977-02-17 monthly 0.5 https://www.510kdatabase.net/og-image/k770207-monitor-oxygen-model-78216c-fda-510k.jpg K770207 - MONITOR, OXYGEN, MODEL 78216C K770207 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Feb 1977. https://www.510kdatabase.net/k770014/ 1977-02-16 monthly 0.5 https://www.510kdatabase.net/og-image/k770014-bacteria-sampler-fda-510k.jpg K770014 - BACTERIA SAMPLER K770014 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Feb 1977. https://www.510kdatabase.net/k761319/ 1977-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k761319-karaya-gum-products-process-change-fda-510k.jpg K761319 - KARAYA GUM PRODUCTS - PROCESS CHANGE K761319 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Howmedica Corp.. Cleared Feb 1977. https://www.510kdatabase.net/k770180/ 1977-02-15 monthly 0.5 https://www.510kdatabase.net/og-image/k770180-sub-of-diacetone-acrylamide-fda-510k.jpg K770180 - SUB. OF DIACETONE ACRYLAMIDE K770180 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Feb 1977. https://www.510kdatabase.net/k770087/ 1977-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k770087-iv-pump-abbottshaw-lifecare-fda-510k.jpg K770087 - I.V. PUMP, ABBOTT/SHAW LIFECARE K770087 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Feb 1977. https://www.510kdatabase.net/k770088/ 1977-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k770088-gamma-4000-scintillation-counter-fda-510k.jpg K770088 - GAMMA 4000 SCINTILLATION COUNTER K770088 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Feb 1977. https://www.510kdatabase.net/k770234/ 1977-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k770234-model-880-rehabilitation-trainer-fda-510k.jpg K770234 - MODEL 880 REHABILITATION TRAINER K770234 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Quinton, Inc.. Cleared Feb 1977. https://www.510kdatabase.net/k770241/ 1977-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k770241-neonatal-t4-ria-kit-fda-510k.jpg K770241 - NEONATAL T4 RIA KIT K770241 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Feb 1977. https://www.510kdatabase.net/k770249/ 1977-02-14 monthly 0.5 https://www.510kdatabase.net/og-image/k770249-ventilator-set-code-2c7109-fda-510k.jpg K770249 - VENTILATOR SET - CODE 2C7109 K770249 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Feb 1977. https://www.510kdatabase.net/k761148/ 1977-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k761148-reflomatreflotest-system-fda-510k.jpg K761148 - REFLOMAT/REFLOTEST SYSTEM K761148 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Feb 1977. https://www.510kdatabase.net/k770142/ 1977-02-11 monthly 0.5 https://www.510kdatabase.net/og-image/k770142-sma-reference-serum-3-fda-510k.jpg K770142 - SMA REFERENCE SERUM 3 K770142 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Feb 1977. https://www.510kdatabase.net/k770183/ 1977-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k770183-o22um-filterset-wflashback-fda-510k.jpg K770183 - O.22/UM FILTERSET W/FLASHBACK K770183 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Feb 1977. https://www.510kdatabase.net/k770218/ 1977-02-09 monthly 0.5 https://www.510kdatabase.net/og-image/k770218-shiley-pediatric-murphy-endotrach-tube-fda-510k.jpg K770218 - SHILEY PEDIATRIC MURPHY ENDOTRACH. TUBE K770218 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Shiley, Inc.. Cleared Feb 1977. https://www.510kdatabase.net/k770051/ 1977-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k770051-venoset-for-iv-fat-emulsion-fda-510k.jpg K770051 - VENOSET FOR I.V. FAT EMULSION K770051 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Abbott Laboratories. Cleared Feb 1977. https://www.510kdatabase.net/k770184/ 1977-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k770184-bi-centric-endoprostheses-fda-510k.jpg K770184 - BI-CENTRIC ENDOPROSTHESES K770184 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Feb 1977. https://www.510kdatabase.net/k770203/ 1977-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k770203-hand-reamers-fda-510k.jpg K770203 - HAND REAMERS K770203 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Feb 1977. https://www.510kdatabase.net/k770204/ 1977-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k770204-cement-extractor-drill-fda-510k.jpg K770204 - CEMENT EXTRACTOR DRILL K770204 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Feb 1977. https://www.510kdatabase.net/k770205/ 1977-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k770205-cement-chisels-fda-510k.jpg K770205 - CEMENT CHISELS K770205 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Feb 1977. https://www.510kdatabase.net/k770206/ 1977-02-08 monthly 0.5 https://www.510kdatabase.net/og-image/k770206-grasping-forceps-fda-510k.jpg K770206 - GRASPING FORCEPS K770206 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Depuy, Inc.. Cleared Feb 1977. https://www.510kdatabase.net/k761351/ 1977-02-02 monthly 0.5 https://www.510kdatabase.net/og-image/k761351-l080-series-liquid-chromatograph-fda-510k.jpg K761351 - L080 SERIES LIQUID CHROMATOGRAPH K761351 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Feb 1977. https://www.510kdatabase.net/k761342/ 1977-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k761342-sma-microlyzer-fda-510k.jpg K761342 - SMA MICROLYZER K761342 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Feb 1977. https://www.510kdatabase.net/k770123/ 1977-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k770123-exercise-respiratory-gas-analyzer-fda-510k.jpg K770123 - EXERCISE RESPIRATORY GAS ANALYZER K770123 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Respironics, Inc.. Cleared Feb 1977. https://www.510kdatabase.net/k770137/ 1977-02-01 monthly 0.5 https://www.510kdatabase.net/og-image/k770137-negative-pressure-adapter-5m1350-fda-510k.jpg K770137 - NEGATIVE PRESSURE ADAPTER 5M1350 K770137 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Feb 1977. https://www.510kdatabase.net/k770131/ 1977-01-28 monthly 0.5 https://www.510kdatabase.net/og-image/k770131-lew-prosthetic-locking-device-fda-510k.jpg K770131 - LEW PROSTHETIC LOCKING DEVICE K770131 is a FDA 510(k) cleared dental medical device. Manufacturer: Howmedica Corp.. Cleared Jan 1977. https://www.510kdatabase.net/k761083/ 1977-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k761083-bard-urine-meter-w-bag-fda-510k.jpg K761083 - BARD URINE METER W/ BAG K761083 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Jan 1977. https://www.510kdatabase.net/k761136/ 1977-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k761136-glucose-analyzer-2-w-choles-reag-kt-fda-510k.jpg K761136 - GLUCOSE ANALYZER 2 W/ CHOLES. REAG KT K761136 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jan 1977. https://www.510kdatabase.net/k770049/ 1977-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k770049-ldh-isotrol-t-fda-510k.jpg K770049 - LDH ISOTROL T K770049 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Jan 1977. https://www.510kdatabase.net/k770062/ 1977-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k770062-gdh-glucose-rate-reagent-kit-fda-510k.jpg K770062 - GDH-GLUCOSE (RATE) REAGENT KIT K770062 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jan 1977. https://www.510kdatabase.net/k770072/ 1977-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k770072-bio-trol-t-triolein-solutions-fda-510k.jpg K770072 - BIO TROL-T TRIOLEIN SOLUTIONS K770072 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Jan 1977. https://www.510kdatabase.net/k770122/ 1977-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k770122-prostate-biopsy-needle-fda-510k.jpg K770122 - PROSTATE BIOPSY NEEDLE K770122 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook, Inc.. Cleared Jan 1977. https://www.510kdatabase.net/k770128/ 1977-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k770128-bg-compression-system-fda-510k.jpg K770128 - B.G. COMPRESSION SYSTEM K770128 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jan 1977. https://www.510kdatabase.net/k770130/ 1977-01-26 monthly 0.5 https://www.510kdatabase.net/og-image/k770130-bg-flexible-nail-system-fda-510k.jpg K770130 - B.G. FLEXIBLE NAIL SYSTEM K770130 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Jan 1977. https://www.510kdatabase.net/k761060/ 1977-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k761060-glucose-analyzer-2-fda-510k.jpg K761060 - GLUCOSE ANALYZER 2 K761060 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jan 1977. https://www.510kdatabase.net/k761061/ 1977-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k761061-blood-urea-nitrogen-bun-analyzer-2-fda-510k.jpg K761061 - BLOOD-UREA-NITROGEN (BUN) ANALYZER 2 K761061 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jan 1977. https://www.510kdatabase.net/k761089/ 1977-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k761089-glucose-analyzer-w-cholesterol-reag-kit-fda-510k.jpg K761089 - GLUCOSE ANALYZER W/ CHOLESTEROL REAG KIT K761089 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Jan 1977. https://www.510kdatabase.net/k770101/ 1977-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k770101-shepard-lens-forcep-w-irrigator-lock-fda-510k.jpg K770101 - SHEPARD LENS FORCEP W/ IRRIGATOR & LOCK K770101 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Edward Weck, Inc.. Cleared Jan 1977. https://www.510kdatabase.net/k770103/ 1977-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k770103-hook-iris-shepard-u-shaped-fda-510k.jpg K770103 - HOOK, IRIS, SHEPARD U-SHAPED K770103 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Edward Weck, Inc.. Cleared Jan 1977. https://www.510kdatabase.net/k770105/ 1977-01-25 monthly 0.5 https://www.510kdatabase.net/og-image/k770105-shepard-ii-lens-forcep-w-lock-fda-510k.jpg K770105 - SHEPARD II, LENS FORCEP W/ LOCK K770105 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Edward Weck, Inc.. Cleared Jan 1977. https://www.510kdatabase.net/k770097/ 1977-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k770097-hershman-lens-forceps-with-irrigator-fda-510k.jpg K770097 - HERSHMAN LENS FORCEPS WITH IRRIGATOR K770097 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Edward Weck, Inc.. Cleared Jan 1977. https://www.510kdatabase.net/k770098/ 1977-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k770098-hook-iris-hershman-fda-510k.jpg K770098 - HOOK, IRIS, HERSHMAN K770098 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Edward Weck, Inc.. Cleared Jan 1977. https://www.510kdatabase.net/k770099/ 1977-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k770099-shepard-lens-forcep-w-irriga-wout-lock-fda-510k.jpg K770099 - SHEPARD LENS FORCEP W/ IRRIGA W/OUT LOCK K770099 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Edward Weck, Inc.. Cleared Jan 1977. https://www.510kdatabase.net/k770100/ 1977-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k770100-binkhorst-lens-forcep-w-irrigator-fda-510k.jpg K770100 - BINKHORST LENS FORCEP W/ IRRIGATOR K770100 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Edward Weck, Inc.. Cleared Jan 1977. https://www.510kdatabase.net/k770102/ 1977-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k770102-hershman-lens-forceps-wout-irrigator-fda-510k.jpg K770102 - HERSHMAN LENS FORCEPS W/OUT IRRIGATOR K770102 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Edward Weck, Inc.. Cleared Jan 1977. https://www.510kdatabase.net/k770104/ 1977-01-24 monthly 0.5 https://www.510kdatabase.net/og-image/k770104-binkhorst-lens-forceps-wout-irrigator-fda-510k.jpg K770104 - BINKHORST LENS FORCEPS W/OUT IRRIGATOR K770104 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Edward Weck, Inc.. Cleared Jan 1977. https://www.510kdatabase.net/k770070/ 1977-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k770070-enit-aba-thyroxine-assay-fda-510k.jpg K770070 - ENIT ABA THYROXINE ASSAY K770070 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Syva Co.. Cleared Jan 1977. https://www.510kdatabase.net/k770085/ 1977-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k770085-robbett-microsurgical-laryngoscope-fda-510k.jpg K770085 - ROBBETT MICROSURGICAL LARYNGOSCOPE K770085 is a FDA 510(k) cleared ear, nose, throat medical device. Manufacturer: Edward Weck, Inc.. Cleared Jan 1977. https://www.510kdatabase.net/k770094/ 1977-01-21 monthly 0.5 https://www.510kdatabase.net/og-image/k770094-fluoricon-500-image-intensifiers-fda-510k.jpg K770094 - FLUORICON 500 IMAGE INTENSIFIERS K770094 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jan 1977. https://www.510kdatabase.net/k770006/ 1977-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k770006-mpx-80-fda-510k.jpg K770006 - MPX 80 K770006 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jan 1977. https://www.510kdatabase.net/k770007/ 1977-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k770007-mpx-100-fda-510k.jpg K770007 - MPX 100 K770007 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jan 1977. https://www.510kdatabase.net/k770008/ 1977-01-18 monthly 0.5 https://www.510kdatabase.net/og-image/k770008-mpx-125-fda-510k.jpg K770008 - MPX 125 K770008 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Jan 1977. https://www.510kdatabase.net/k761359/ 1977-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k761359-neomycin-agar-with-5-sheep-blood-fda-510k.jpg K761359 - NEOMYCIN AGAR WITH 5% SHEEP BLOOD K761359 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Jan 1977. https://www.510kdatabase.net/k770036/ 1977-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k770036-cardiotomy-reservoir-fda-510k.jpg K770036 - CARDIOTOMY RESERVOIR K770036 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Shiley, Inc.. Cleared Jan 1977. https://www.510kdatabase.net/k770038/ 1977-01-14 monthly 0.5 https://www.510kdatabase.net/og-image/k770038-monitor-heartwatch-heart-rate-fda-510k.jpg K770038 - MONITOR, HEARTWATCH HEART RATE K770038 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Respironics, Inc.. Cleared Jan 1977. https://www.510kdatabase.net/k760969/ 1977-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k760969-phblood-gas-system-fda-510k.jpg K760969 - PH/BLOOD GAS SYSTEM K760969 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jan 1977. https://www.510kdatabase.net/k760975/ 1977-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k760975-weil-oncometer-il-186-fda-510k.jpg K760975 - WEIL ONCOMETER (IL 186) K760975 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Jan 1977. https://www.510kdatabase.net/k761007/ 1977-01-12 monthly 0.5 https://www.510kdatabase.net/og-image/k761007-artificial-kidney-c-dak-cordis-dow-fda-510k.jpg K761007 - ARTIFICIAL KIDNEY, C-DAK CORDIS DOW K761007 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cordis Corp.. Cleared Jan 1977. https://www.510kdatabase.net/k770009/ 1977-01-10 monthly 0.5 https://www.510kdatabase.net/og-image/k770009-biobond-cb-post-solder-fda-510k.jpg K770009 - BIOBOND C&B POST SOLDER K770009 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Jan 1977. https://www.510kdatabase.net/k761307/ 1977-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k761307-auto-syringe-model-as-3a-fda-510k.jpg K761307 - AUTO SYRINGE MODEL AS-3A K761307 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Baxter Healthcare Corp. Cleared Jan 1977. https://www.510kdatabase.net/k761308/ 1977-01-06 monthly 0.5 https://www.510kdatabase.net/og-image/k761308-electronic-stethoscope-fda-510k.jpg K761308 - ELECTRONIC STETHOSCOPE K761308 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Medline Industries, Inc.. Cleared Jan 1977. https://www.510kdatabase.net/k761278/ 1977-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k761278-total-tibial-knee-fda-510k.jpg K761278 - TOTAL TIBIAL KNEE K761278 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Jan 1977. https://www.510kdatabase.net/k761302/ 1977-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k761302-electronic-blood-pressure-unit-fda-510k.jpg K761302 - ELECTRONIC BLOOD PRESSURE UNIT K761302 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Medline Industries, Inc.. Cleared Jan 1977. https://www.510kdatabase.net/k761335/ 1977-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k761335-band-aid-brand-sheer-bandages-fda-510k.jpg K761335 - BAND-AID BRAND SHEER BANDAGES K761335 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jan 1977. https://www.510kdatabase.net/k761336/ 1977-01-05 monthly 0.5 https://www.510kdatabase.net/og-image/k761336-band-aid-brand-plastic-bandages-fda-510k.jpg K761336 - BAND-AID BRAND PLASTIC BANDAGES K761336 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Jan 1977. https://www.510kdatabase.net/k761287/ 1977-01-03 monthly 0.5 https://www.510kdatabase.net/og-image/k761287-5m1352-proport-dialysis-fluid-delivery-fda-510k.jpg K761287 - 5M1352 PROPORT. DIALYSIS FLUID DELIV.ERY K761287 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Jan 1977. https://www.510kdatabase.net/k760662/ 1976-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k760662-sterilwrap22190123456789-fda-510k.jpg K760662 - STERIL.WRAP(#221901,2,3,4,5,6,7,8,9) K760662 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 1976. https://www.510kdatabase.net/k760880/ 1976-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k760880-additive-cap-2b8905-fda-510k.jpg K760880 - ADDITIVE CAP (2B8905) K760880 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Dec 1976. https://www.510kdatabase.net/k761064/ 1976-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k761064-coventry-staple-fda-510k.jpg K761064 - COVENTRY STAPLE K761064 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Depuy, Inc.. Cleared Dec 1976. https://www.510kdatabase.net/k761235/ 1976-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k761235-laser-standard-serum-fda-510k.jpg K761235 - LASER STANDARD SERUM K761235 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Dec 1976. https://www.510kdatabase.net/k761236/ 1976-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k761236-antiserum-human-pro-nephelometric-gr-fda-510k.jpg K761236 - ANTISERUM HUMAN (PRO.) NEPHELOMETRIC GR. K761236 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Dec 1976. https://www.510kdatabase.net/k761270/ 1976-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k761270-immuno-tec-ii-ot-agarose-plate-kit-fda-510k.jpg K761270 - IMMUNO-TEC II OT AGAROSE PLATE KIT K761270 is a FDA 510(k) cleared immunology medical device. Manufacturer: Behring Diagnostics, Inc.. Cleared Dec 1976. https://www.510kdatabase.net/k761311/ 1976-12-30 monthly 0.5 https://www.510kdatabase.net/og-image/k761311-accraassay-rid-kits-fda-510k.jpg K761311 - ACCRAASSAY RID KITS K761311 is a FDA 510(k) cleared immunology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Dec 1976. https://www.510kdatabase.net/k760898/ 1976-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k760898-goldfarb-liver-clamp-fda-510k.jpg K760898 - GOLDFARB LIVER CLAMP K760898 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Edward Weck, Inc.. Cleared Dec 1976. https://www.510kdatabase.net/k761261/ 1976-12-29 monthly 0.5 https://www.510kdatabase.net/og-image/k761261-enzymatic-bun-rate-reagent-kit-fda-510k.jpg K761261 - ENZYMATIC BUN (RATE) REAGENT KIT K761261 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Dec 1976. https://www.510kdatabase.net/k761291/ 1976-12-28 monthly 0.5 https://www.510kdatabase.net/og-image/k761291-central-station-monitoring-system-fda-510k.jpg K761291 - CENTRAL STATION MONITORING SYSTEM K761291 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Laboratories. Cleared Dec 1976. https://www.510kdatabase.net/k761275/ 1976-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k761275-airotos-lf-handpiece-fda-510k.jpg K761275 - AIROTOS LF HANDPIECE K761275 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Dec 1976. https://www.510kdatabase.net/k761276/ 1976-12-23 monthly 0.5 https://www.510kdatabase.net/og-image/k761276-dental-stool-fda-510k.jpg K761276 - DENTAL STOOL K761276 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Dec 1976. https://www.510kdatabase.net/k760967/ 1976-12-22 monthly 0.5 https://www.510kdatabase.net/og-image/k760967-tobramycin-ria-kit-fda-510k.jpg K760967 - TOBRAMYCIN RIA KIT K760967 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Dec 1976. https://www.510kdatabase.net/k761197/ 1976-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k761197-cholesterol-calibrator-fda-510k.jpg K761197 - CHOLESTEROL CALIBRATOR K761197 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Dec 1976. https://www.510kdatabase.net/k761200/ 1976-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k761200-enzymatic-triglycerides-end-point-fda-510k.jpg K761200 - ENZYMATIC TRIGLYCERIDES (END POINT) K761200 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Dec 1976. https://www.510kdatabase.net/k761212/ 1976-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k761212-cpk1soenzymes-determination-pro-715-ep-fda-510k.jpg K761212 - CPK1SOENZYMES DETERMINATION PRO. #715-EP K761212 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Dec 1976. https://www.510kdatabase.net/k761259/ 1976-12-21 monthly 0.5 https://www.510kdatabase.net/og-image/k761259-ge-telemetry-monitoring-fda-510k.jpg K761259 - G.E. TELEMETRY MONITORING K761259 is a FDA 510(k) cleared neurology medical device. Manufacturer: General Electric Co.. Cleared Dec 1976. https://www.510kdatabase.net/k760968/ 1976-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k760968-central-station-repeater-model-8032a-fda-510k.jpg K760968 - CENTRAL STATION REPEATER (MODEL 8032A) K760968 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: Hewlett-Packard Co.. Cleared Dec 1976. https://www.510kdatabase.net/k761088/ 1976-12-17 monthly 0.5 https://www.510kdatabase.net/og-image/k761088-depuy-modified-skeletal-traction-pin-fda-510k.jpg K761088 - DEPUY MODIFIED SKELETAL TRACTION PIN K761088 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Dec 1976. https://www.510kdatabase.net/k760874/ 1976-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k760874-vi-octoson-ultrasonic-system-fda-510k.jpg K760874 - V.I. OCTOSON ULTRASONIC SYSTEM K760874 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: General Electric Co.. Cleared Dec 1976. https://www.510kdatabase.net/k761214/ 1976-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k761214-well-counters-logic-ii-200-series-fda-510k.jpg K761214 - WELL COUNTERS, LOGIC II (200 SERIES) K761214 is a FDA 510(k) cleared radiology medical device. Manufacturer: Abbott Laboratories. Cleared Dec 1976. https://www.510kdatabase.net/k761251/ 1976-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k761251-weck-tying-forcep-straight-titanium-fda-510k.jpg K761251 - WECK TYING FORCEP, STRAIGHT TITANIUM K761251 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Edward Weck, Inc.. Cleared Dec 1976. https://www.510kdatabase.net/k761252/ 1976-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k761252-weck-tying-forcep-curved-titanium-fda-510k.jpg K761252 - WECK TYING FORCEP, CURVED TITANIUM K761252 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Edward Weck, Inc.. Cleared Dec 1976. https://www.510kdatabase.net/k761253/ 1976-12-16 monthly 0.5 https://www.510kdatabase.net/og-image/k761253-cyclodialysis-spat-15mm-blade-titanium-fda-510k.jpg K761253 - CYCLODIALYSIS SPAT. 15MM BLADE TITANIUM K761253 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Edward Weck, Inc.. Cleared Dec 1976. https://www.510kdatabase.net/k761228/ 1976-12-15 monthly 0.5 https://www.510kdatabase.net/og-image/k761228-luhr-mandibular-compression-screw-system-fda-510k.jpg K761228 - LUHR MANDIBULAR COMPRESSION-SCREW SYSTEM K761228 is a FDA 510(k) cleared dental medical device. Manufacturer: Howmedica Corp.. Cleared Dec 1976. https://www.510kdatabase.net/k761165/ 1976-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k761165-mt-ii-test-for-continuous-flow-anal-fda-510k.jpg K761165 - MT II - TEST FOR CONTINUOUS FLOW ANAL K761165 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Dec 1976. https://www.510kdatabase.net/k761203/ 1976-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k761203-absorbent-points-fda-510k.jpg K761203 - ABSORBENT POINTS K761203 is a FDA 510(k) cleared dental medical device. Manufacturer: Johnson & Johnson Professionals, Inc.. Cleared Dec 1976. https://www.510kdatabase.net/k761211/ 1976-12-13 monthly 0.5 https://www.510kdatabase.net/og-image/k761211-model-15050a-digital-display-fda-510k.jpg K761211 - MODEL 15050A DIGITAL DISPLAY K761211 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Dec 1976. https://www.510kdatabase.net/k761055/ 1976-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k761055-calculator-plotter-model-9872a-fda-510k.jpg K761055 - CALCULATOR PLOTTER (MODEL 9872A) K761055 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Dec 1976. https://www.510kdatabase.net/k761056/ 1976-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k761056-display-monitor-model-78301a-fda-510k.jpg K761056 - DISPLAY MONITOR (MODEL 78301A) K761056 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Dec 1976. https://www.510kdatabase.net/k761149/ 1976-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k761149-model-203-dispenser-fda-510k.jpg K761149 - MODEL 203 DISPENSER K761149 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Dec 1976. https://www.510kdatabase.net/k761151/ 1976-12-09 monthly 0.5 https://www.510kdatabase.net/og-image/k761151-infusion-pump-fda-510k.jpg K761151 - INFUSION PUMP K761151 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Dec 1976. https://www.510kdatabase.net/k760858/ 1976-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k760858-rutner-universal-wedge-catheter-fda-510k.jpg K760858 - RUTNER UNIVERSAL WEDGE CATHETER K760858 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Cook, Inc.. Cleared Dec 1976. https://www.510kdatabase.net/k761159/ 1976-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k761159-portacamera-11-b-fda-510k.jpg K761159 - PORTACAMERA 11-B K761159 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Dec 1976. https://www.510kdatabase.net/k761161/ 1976-12-06 monthly 0.5 https://www.510kdatabase.net/og-image/k761161-67-8006-darling-linton-aortic-tourn-fda-510k.jpg K761161 - 67-8006 DARLING-LINTON AORTIC TOURN. K761161 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Dec 1976. https://www.510kdatabase.net/k760661/ 1976-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k760661-sterilizer-wrap-cat22183123456-fda-510k.jpg K760661 - STERILIZER WRAP (CAT#221831,2,3,4,5,6) K760661 is a FDA 510(k) cleared general hospital medical device. Manufacturer: C.R. Bard, Inc.. Cleared Dec 1976. https://www.510kdatabase.net/k760878/ 1976-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k760878-bongort-ileostomy-pouch-fda-510k.jpg K760878 - BONGORT ILEOSTOMY POUCH K760878 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Howmedica Corp.. Cleared Dec 1976. https://www.510kdatabase.net/k761063/ 1976-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k761063-gammacord-ii-calculator-interface-fda-510k.jpg K761063 - GAMMACORD II CALCULATOR INTERFACE K761063 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Dec 1976. https://www.510kdatabase.net/k761090/ 1976-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k761090-diagnostic-method-8-glutamyltransferase-fda-510k.jpg K761090 - DIAGNOSTIC METHOD-8-GLUTAMYLTRANSFERASE K761090 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Technicon Instruments Corp.. Cleared Dec 1976. https://www.510kdatabase.net/k761104/ 1976-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k761104-adult-swivel-fork-fda-510k.jpg K761104 - ADULT SWIVEL FORK K761104 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1976. https://www.510kdatabase.net/k761105/ 1976-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k761105-weighted-spork-fda-510k.jpg K761105 - WEIGHTED SPORK K761105 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1976. https://www.510kdatabase.net/k761106/ 1976-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k761106-weighted-fork-fda-510k.jpg K761106 - WEIGHTED FORK K761106 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1976. https://www.510kdatabase.net/k761107/ 1976-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k761107-food-guards-fda-510k.jpg K761107 - FOOD GUARDS K761107 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1976. https://www.510kdatabase.net/k761108/ 1976-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k761108-plastic-disposable-bib-fda-510k.jpg K761108 - PLASTIC DISPOSABLE BIB K761108 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1976. https://www.510kdatabase.net/k761109/ 1976-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k761109-terrycloth-bibs-fda-510k.jpg K761109 - TERRYCLOTH BIBS K761109 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1976. https://www.510kdatabase.net/k761110/ 1976-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k761110-bed-tray-fda-510k.jpg K761110 - BED TRAY K761110 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1976. https://www.510kdatabase.net/k761111/ 1976-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k761111-square-food-guard-fda-510k.jpg K761111 - SQUARE FOOD GUARD K761111 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1976. https://www.510kdatabase.net/k761112/ 1976-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k761112-plastic-hand-cone-fda-510k.jpg K761112 - PLASTIC HAND CONE K761112 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1976. https://www.510kdatabase.net/k761113/ 1976-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k761113-built-up-handle-utensils-fda-510k.jpg K761113 - BUILT-UP HANDLE UTENSILS K761113 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1976. https://www.510kdatabase.net/k761114/ 1976-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k761114-foam-slippers-fda-510k.jpg K761114 - FOAM SLIPPERS K761114 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1976. https://www.510kdatabase.net/k761115/ 1976-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k761115-rolling-pin-fda-510k.jpg K761115 - ROLLING PIN K761115 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1976. https://www.510kdatabase.net/k761116/ 1976-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k761116-breath-control-game-fda-510k.jpg K761116 - BREATH CONTROL GAME K761116 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1976. https://www.510kdatabase.net/k761117/ 1976-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k761117-keyboard-sheilds-fda-510k.jpg K761117 - KEYBOARD SHEILDS K761117 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1976. https://www.510kdatabase.net/k761118/ 1976-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k761118-hand-screw-clamp-fda-510k.jpg K761118 - HAND SCREW CLAMP K761118 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1976. https://www.510kdatabase.net/k761119/ 1976-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k761119-sheet-metal-clamp-fda-510k.jpg K761119 - SHEET METAL CLAMP K761119 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1976. https://www.510kdatabase.net/k761120/ 1976-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k761120-spin-a-pull-fda-510k.jpg K761120 - SPIN-A-PULL K761120 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1976. https://www.510kdatabase.net/k761121/ 1976-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k761121-electric-vibrator-fda-510k.jpg K761121 - ELECTRIC VIBRATOR K761121 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1976. https://www.510kdatabase.net/k761122/ 1976-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k761122-pruning-scissors-fda-510k.jpg K761122 - PRUNING SCISSORS K761122 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1976. https://www.510kdatabase.net/k761123/ 1976-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k761123-electric-razor-holder-fda-510k.jpg K761123 - ELECTRIC RAZOR HOLDER K761123 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1976. https://www.510kdatabase.net/k761124/ 1976-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k761124-weed-puller-pruner-fda-510k.jpg K761124 - WEED PULLER & PRUNER K761124 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1976. https://www.510kdatabase.net/k761125/ 1976-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k761125-long-handled-sponge-fda-510k.jpg K761125 - LONG HANDLED SPONGE K761125 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1976. https://www.510kdatabase.net/k761126/ 1976-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k761126-extra-large-long-handled-sponge-fda-510k.jpg K761126 - EXTRA LARGE LONG HANDLED SPONGE K761126 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1976. https://www.510kdatabase.net/k761127/ 1976-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k761127-long-handled-bath-brush-fda-510k.jpg K761127 - LONG HANDLED BATH BRUSH K761127 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1976. https://www.510kdatabase.net/k761128/ 1976-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k761128-lateral-trunk-supports-fda-510k.jpg K761128 - LATERAL TRUNK SUPPORTS K761128 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1976. https://www.510kdatabase.net/k761129/ 1976-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k761129-contoured-raised-toilet-seat-fda-510k.jpg K761129 - CONTOURED RAISED TOILET SEAT K761129 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1976. https://www.510kdatabase.net/k761130/ 1976-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k761130-bathtub-rails-fda-510k.jpg K761130 - BATHTUB RAILS K761130 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1976. https://www.510kdatabase.net/k761131/ 1976-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k761131-safety-pin-splint-fda-510k.jpg K761131 - SAFETY PIN SPLINT K761131 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1976. https://www.510kdatabase.net/k761132/ 1976-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k761132-tuning-fork-fda-510k.jpg K761132 - TUNING FORK K761132 is a FDA 510(k) cleared neurology medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1976. https://www.510kdatabase.net/k761133/ 1976-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k761133-aesthesiometer-fda-510k.jpg K761133 - AESTHESIOMETER K761133 is a FDA 510(k) cleared neurology medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1976. https://www.510kdatabase.net/k761134/ 1976-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k761134-plastic-finger-cuffs-fda-510k.jpg K761134 - PLASTIC FINGER CUFFS K761134 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1976. https://www.510kdatabase.net/k761135/ 1976-12-02 monthly 0.5 https://www.510kdatabase.net/og-image/k761135-short-inflated-rolls-fda-510k.jpg K761135 - SHORT INFLATED ROLLS K761135 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Dec 1976. https://www.510kdatabase.net/k760711/ 1976-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k760711-reagent-system-no-sc-135-fda-510k.jpg K760711 - REAGENT SYSTEM (NO. SC 135) K760711 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Nov 1976. https://www.510kdatabase.net/k761095/ 1976-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k761095-vanderbilt-curette-fda-510k.jpg K761095 - VANDERBILT CURETTE K761095 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Nov 1976. https://www.510kdatabase.net/k761096/ 1976-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k761096-vanderbilt-pituitary-retractor-fda-510k.jpg K761096 - VANDERBILT PITUITARY RETRACTOR K761096 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Nov 1976. https://www.510kdatabase.net/k761097/ 1976-11-30 monthly 0.5 https://www.510kdatabase.net/og-image/k761097-vanderbilt-blade-holder-fda-510k.jpg K761097 - VANDERBILT BLADE HOLDER K761097 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Nov 1976. https://www.510kdatabase.net/k760713/ 1976-11-29 monthly 0.5 https://www.510kdatabase.net/og-image/k760713-triglycerides-test-fda-510k.jpg K760713 - TRIGLYCERIDES TEST K760713 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Nov 1976. https://www.510kdatabase.net/k760634/ 1976-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k760634-aca-phosphorus-analytical-test-pack-fda-510k.jpg K760634 - ACA PHOSPHORUS ANALYTICAL TEST PACK K760634 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Nov 1976. https://www.510kdatabase.net/k760685/ 1976-11-24 monthly 0.5 https://www.510kdatabase.net/og-image/k760685-sigma-proced-sc165-fda-510k.jpg K760685 - SIGMA PROCED #SC165 K760685 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Nov 1976. https://www.510kdatabase.net/k760572/ 1976-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k760572-seralute-fda-510k.jpg K760572 - SERALUTE K760572 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Nov 1976. https://www.510kdatabase.net/k760914/ 1976-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k760914-double-elutra-pack-unit-fda-510k.jpg K760914 - DOUBLE ELUTRA-PACK UNIT K760914 is a FDA 510(k) cleared hematology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Nov 1976. https://www.510kdatabase.net/k761002/ 1976-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k761002-charnley-congenital-hip-femur-85-3060-fda-510k.jpg K761002 - CHARNLEY CONGENITAL HIP FEMUR (85-3060) K761002 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Nov 1976. https://www.510kdatabase.net/k761003/ 1976-11-23 monthly 0.5 https://www.510kdatabase.net/og-image/k761003-charnley-congenital-hip-femur-85-3061-fda-510k.jpg K761003 - CHARNLEY CONGENITAL HIP FEMUR (85-3061) K761003 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Nov 1976. https://www.510kdatabase.net/k760905/ 1976-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k760905-supermax-automatic-x-ray-processor-fda-510k.jpg K760905 - SUPERMAX AUTOMATIC X-RAY PROCESSOR K760905 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Nov 1976. https://www.510kdatabase.net/k760922/ 1976-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k760922-perfusion-tubing-set-fda-510k.jpg K760922 - PERFUSION TUBING SET K760922 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Shiley, Inc.. Cleared Nov 1976. https://www.510kdatabase.net/k760936/ 1976-11-19 monthly 0.5 https://www.510kdatabase.net/og-image/k760936-emit-amphetamine-confirmation-reagent-fda-510k.jpg K760936 - EMIT AMPHETAMINE CONFIRMATION REAGENT K760936 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Nov 1976. https://www.510kdatabase.net/k760701/ 1976-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k760701-sulfacytine-025-mg-fda-510k.jpg K760701 - SULFACYTINE 0.25 MG. K760701 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Nov 1976. https://www.510kdatabase.net/k760739/ 1976-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k760739-aca-data-mate-accessory-fda-510k.jpg K760739 - ACA DATA MATE ACCESSORY K760739 is a FDA 510(k) cleared chemistry medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Nov 1976. https://www.510kdatabase.net/k760780/ 1976-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k760780-double-ended-needle-fda-510k.jpg K760780 - DOUBLE-ENDED NEEDLE K760780 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Nov 1976. https://www.510kdatabase.net/k760889/ 1976-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k760889-test-for-detection-of-antirubella-antib-fda-510k.jpg K760889 - TEST FOR DETECTION OF ANTIRUBELLA ANTIB K760889 is a FDA 510(k) cleared immunology medical device. Manufacturer: Abbott Laboratories. Cleared Nov 1976. https://www.510kdatabase.net/k760900/ 1976-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k760900-gamma-scintillation-counter-fda-510k.jpg K760900 - GAMMA SCINTILLATION COUNTER K760900 is a FDA 510(k) cleared immunology medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Nov 1976. https://www.510kdatabase.net/k760939/ 1976-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k760939-cortisol-reagent-system-fda-510k.jpg K760939 - CORTISOL REAGENT SYSTEM K760939 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Nov 1976. https://www.510kdatabase.net/k760974/ 1976-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k760974-charnley-femoral-component-fda-510k.jpg K760974 - CHARNLEY FEMORAL COMPONENT K760974 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Nov 1976. https://www.510kdatabase.net/k760976/ 1976-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k760976-charnley-revision-set-fda-510k.jpg K760976 - CHARNLEY REVISION SET K760976 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Nov 1976. https://www.510kdatabase.net/k760977/ 1976-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k760977-charnley-femur-drill-1-and-2-fda-510k.jpg K760977 - CHARNLEY FEMUR DRILL #1 AND #2 K760977 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Nov 1976. https://www.510kdatabase.net/k761019/ 1976-11-16 monthly 0.5 https://www.510kdatabase.net/og-image/k761019-pipetter-diluter-model-273-fda-510k.jpg K761019 - PIPETTER-DILUTER (MODEL 273) K761019 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Nov 1976. https://www.510kdatabase.net/k761017/ 1976-11-15 monthly 0.5 https://www.510kdatabase.net/og-image/k761017-pressure-module-model-p3-fda-510k.jpg K761017 - PRESSURE MODULE (MODEL P3) K761017 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Nov 1976. https://www.510kdatabase.net/k760586/ 1976-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k760586-suction-kit-fda-510k.jpg K760586 - SUCTION KIT K760586 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Nov 1976. https://www.510kdatabase.net/k760823/ 1976-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k760823-tmo-oxygenator-reservoir-pump-set-fda-510k.jpg K760823 - TMO OXYGENATOR RESERVOIR PUMP SET K760823 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Nov 1976. https://www.510kdatabase.net/k760824/ 1976-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k760824-tmo-total-bypass-membrane-oxygenator-i-fda-510k.jpg K760824 - TMO TOTAL BYPASS MEMBRANE OXYGENATOR-I K760824 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Nov 1976. https://www.510kdatabase.net/k760854/ 1976-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k760854-three-channel-stress-test-system-m633-fda-510k.jpg K760854 - THREE-CHANNEL STRESS TEST SYSTEM (M633) K760854 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Quinton, Inc.. Cleared Nov 1976. https://www.510kdatabase.net/k760961/ 1976-11-12 monthly 0.5 https://www.510kdatabase.net/og-image/k760961-occlusion-clips-fda-510k.jpg K760961 - OCCLUSION CLIPS K760961 is a FDA 510(k) cleared neurology medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Nov 1976. https://www.510kdatabase.net/k760582/ 1976-11-11 monthly 0.5 https://www.510kdatabase.net/og-image/k760582-ha3-hematology-analyzer-fda-510k.jpg K760582 - HA/3 HEMATOLOGY ANALYZER K760582 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Nov 1976. https://www.510kdatabase.net/k760906/ 1976-11-11 monthly 0.5 https://www.510kdatabase.net/og-image/k760906-monomer-vapor-containment-system-fda-510k.jpg K760906 - MONOMER VAPOR CONTAINMENT SYSTEM K760906 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Nov 1976. https://www.510kdatabase.net/k760581/ 1976-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k760581-ha5-hematology-analyzer-fda-510k.jpg K760581 - HA/5 HEMATOLOGY ANALYZER K760581 is a FDA 510(k) cleared hematology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Nov 1976. https://www.510kdatabase.net/k760736/ 1976-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k760736-barimex-barium-sulfate-compound-fda-510k.jpg K760736 - BARIMEX, BARIUM SULFATE COMPOUND K760736 is a FDA 510(k) cleared radiology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Nov 1976. https://www.510kdatabase.net/k760881/ 1976-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k760881-febrile-antigen-control-sera-fda-510k.jpg K760881 - FEBRILE ANTIGEN CONTROL SERA K760881 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Nov 1976. https://www.510kdatabase.net/k760899/ 1976-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k760899-sterile-disposable-cotton-plugged-ser-fda-510k.jpg K760899 - STERILE DISPOSABLE COTTON PLUGGED SER. K760899 is a FDA 510(k) cleared immunology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Nov 1976. https://www.510kdatabase.net/k760938/ 1976-11-09 monthly 0.5 https://www.510kdatabase.net/og-image/k760938-disposable-humidifier-fda-510k.jpg K760938 - DISPOSABLE HUMIDIFIER K760938 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Nov 1976. https://www.510kdatabase.net/k760414/ 1976-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k760414-enzymatic-bun-reagent-kit-fda-510k.jpg K760414 - ENZYMATIC BUN REAGENT KIT K760414 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Nov 1976. https://www.510kdatabase.net/k760415/ 1976-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k760415-enzymatic-amylase-reagent-kit-fda-510k.jpg K760415 - ENZYMATIC AMYLASE REAGENT KIT K760415 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Nov 1976. https://www.510kdatabase.net/k760885/ 1976-11-05 monthly 0.5 https://www.510kdatabase.net/og-image/k760885-ketotrol-e-fda-510k.jpg K760885 - KETOTROL-E K760885 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Nov 1976. https://www.510kdatabase.net/k760732/ 1976-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k760732-skin-stapling-instrument-fda-510k.jpg K760732 - SKIN STAPLING INSTRUMENT K760732 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Nov 1976. https://www.510kdatabase.net/k760733/ 1976-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k760733-skin-staple-extractor-fda-510k.jpg K760733 - SKIN STAPLE EXTRACTOR K760733 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Nov 1976. https://www.510kdatabase.net/k760734/ 1976-11-03 monthly 0.5 https://www.510kdatabase.net/og-image/k760734-regular-and-wide-skin-staples-fda-510k.jpg K760734 - REGULAR AND WIDE SKIN STAPLES K760734 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Ethicon, Inc.. Cleared Nov 1976. https://www.510kdatabase.net/k760424/ 1976-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k760424-liquid-scintillation-counter-fda-510k.jpg K760424 - LIQUID SCINTILLATION COUNTER K760424 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Nov 1976. https://www.510kdatabase.net/k760862/ 1976-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k760862-procedure-no-710-ep-for-alkphos-fda-510k.jpg K760862 - PROCEDURE NO. 710-EP FOR ALK.PHOS. K760862 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Nov 1976. https://www.510kdatabase.net/k760863/ 1976-11-02 monthly 0.5 https://www.510kdatabase.net/og-image/k760863-product-k3002-ketotrol-nurine-control-fda-510k.jpg K760863 - PRODUCT #K3002 KETOTROL-N(URINE CONTROL) K760863 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Nov 1976. https://www.510kdatabase.net/k760430/ 1976-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k760430-bun-reative-fda-510k.jpg K760430 - BUN-REATIVE K760430 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Nov 1976. https://www.510kdatabase.net/k760546/ 1976-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k760546-reagent-kit-enzymatic-co2-fda-510k.jpg K760546 - REAGENT KIT, ENZYMATIC CO2 K760546 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Beckman Instruments, Inc.. Cleared Nov 1976. https://www.510kdatabase.net/k760601/ 1976-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k760601-argyle-suction-control-kit-fda-510k.jpg K760601 - ARGYLE SUCTION CONTROL KIT K760601 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Sherwood Medical Co.. Cleared Nov 1976. https://www.510kdatabase.net/k760745/ 1976-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k760745-yasargil-suction-tube-small-fda-510k.jpg K760745 - YASARGIL SUCTION TUBE - SMALL K760745 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Nov 1976. https://www.510kdatabase.net/k760746/ 1976-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k760746-yasargil-suction-tube-large-fda-510k.jpg K760746 - YASARGIL SUCTION TUBE - LARGE K760746 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Nov 1976. https://www.510kdatabase.net/k760747/ 1976-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k760747-yasargil-suction-tube-medium-fda-510k.jpg K760747 - YASARGIL SUCTION TUBE - MEDIUM K760747 is a FDA 510(k) cleared general & plastic surgery medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Nov 1976. https://www.510kdatabase.net/k760801/ 1976-11-01 monthly 0.5 https://www.510kdatabase.net/og-image/k760801-tsh-ria-kit-fda-510k.jpg K760801 - TSH RIA KIT K760801 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Nov 1976. https://www.510kdatabase.net/k760449/ 1976-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k760449-lipid-control-fda-510k.jpg K760449 - LIPID CONTROL K760449 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Oct 1976. https://www.510kdatabase.net/k760472/ 1976-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k760472-instrumented-system-for-urinalysis-fda-510k.jpg K760472 - INSTRUMENTED SYSTEM FOR URINALYSIS K760472 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Oct 1976. https://www.510kdatabase.net/k760591/ 1976-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k760591-sigma-procedure-no-745-epreagent-sy-fda-510k.jpg K760591 - SIGMA PROCEDURE NO. 745 - EP.REAGENT SY K760591 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Oct 1976. https://www.510kdatabase.net/k760802/ 1976-10-29 monthly 0.5 https://www.510kdatabase.net/og-image/k760802-t-3-uptake-kit-fda-510k.jpg K760802 - T-3 UPTAKE KIT K760802 is a FDA 510(k) cleared immunology medical device. Manufacturer: Diagnostic Products Corp.. Cleared Oct 1976. https://www.510kdatabase.net/k760348/ 1976-10-27 monthly 0.5 https://www.510kdatabase.net/og-image/k760348-reagent-system-sigma-procedure-no-270-fda-510k.jpg K760348 - REAGENT SYSTEM, SIGMA PROCEDURE NO. 270 K760348 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Oct 1976. https://www.510kdatabase.net/k760709/ 1976-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k760709-emit-digokin-assay-fda-510k.jpg K760709 - EMIT DIGOKIN ASSAY K760709 is a FDA 510(k) cleared toxicology medical device. Manufacturer: Syva Co.. Cleared Oct 1976. https://www.510kdatabase.net/k760821/ 1976-10-21 monthly 0.5 https://www.510kdatabase.net/og-image/k760821-reagent-system-fda-510k.jpg K760821 - REAGENT SYSTEM K760821 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Oct 1976. https://www.510kdatabase.net/k760544/ 1976-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k760544-catheter-peritoneal-dialysis-fda-510k.jpg K760544 - CATHETER, PERITONEAL DIALYSIS K760544 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Oct 1976. https://www.510kdatabase.net/k760803/ 1976-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k760803-physiological-monitor-model-870-fda-510k.jpg K760803 - PHYSIOLOGICAL MONITOR (MODEL 870) K760803 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Datascope Corp.. Cleared Oct 1976. https://www.510kdatabase.net/k760842/ 1976-10-20 monthly 0.5 https://www.510kdatabase.net/og-image/k760842-geomedic-anametric-total-knee-fda-510k.jpg K760842 - GEOMEDIC ANAMETRIC TOTAL KNEE K760842 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Oct 1976. https://www.510kdatabase.net/k760584/ 1976-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k760584-u-mid-prefilled-humidifier-500cc-fda-510k.jpg K760584 - U-MID PREFILLED HUMIDIFIER (500CC) K760584 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1976. https://www.510kdatabase.net/k760585/ 1976-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k760585-u-mid-prefilled-nebulizer-fda-510k.jpg K760585 - U-MID PREFILLED NEBULIZER K760585 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1976. https://www.510kdatabase.net/k760587/ 1976-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k760587-u-mid-prefilled-humidifier-300cc-fda-510k.jpg K760587 - U-MID PREFILLED HUMIDIFIER (300CC) K760587 is a FDA 510(k) cleared anesthesiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1976. https://www.510kdatabase.net/k760735/ 1976-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k760735-bongort-special-odorproof-drain-fda-510k.jpg K760735 - BONGORT SPECIAL ODORPROOF DRAIN K760735 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Howmedica Corp.. Cleared Oct 1976. https://www.510kdatabase.net/k760770/ 1976-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k760770-sola-commido-loupe-fda-510k.jpg K760770 - SOLA COMMIDO LOUPE K760770 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Oct 1976. https://www.510kdatabase.net/k760771/ 1976-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k760771-sola-schultze-crock-opthalmoscope-fda-510k.jpg K760771 - SOLA SCHULTZE-CROCK OPTHALMOSCOPE K760771 is a FDA 510(k) cleared ophthalmic medical device. Manufacturer: Codman & Shurtleff, Inc.. Cleared Oct 1976. https://www.510kdatabase.net/k760783/ 1976-10-15 monthly 0.5 https://www.510kdatabase.net/og-image/k760783-biobond-crown-bridge-ceramic-bonding-fda-510k.jpg K760783 - BIOBOND-CROWN & BRIDGE CERAMIC BONDING K760783 is a FDA 510(k) cleared dental medical device. Manufacturer: Dentsply Intl.. Cleared Oct 1976. https://www.510kdatabase.net/k760774/ 1976-10-13 monthly 0.5 https://www.510kdatabase.net/og-image/k760774-time-sharing-multiplexer-model-78308a-fda-510k.jpg K760774 - TIME-SHARING MULTIPLEXER (MODEL 78308A) K760774 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Oct 1976. https://www.510kdatabase.net/k760596/ 1976-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k760596-biotrol-abnormal-fda-510k.jpg K760596 - BIOTROL-ABNORMAL K760596 is a FDA 510(k) cleared hematology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Oct 1976. https://www.510kdatabase.net/k760597/ 1976-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k760597-biotrol-normal-fda-510k.jpg K760597 - BIOTROL-NORMAL K760597 is a FDA 510(k) cleared hematology medical device. Manufacturer: Boehringer Mannheim Corp.. Cleared Oct 1976. https://www.510kdatabase.net/k760641/ 1976-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k760641-myelography-tray-wchynn-myelography-n-fda-510k.jpg K760641 - MYELOGRAPHY TRAY W/CHYNN MYELOGRAPHY N K760641 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1976. https://www.510kdatabase.net/k760643/ 1976-10-08 monthly 0.5 https://www.510kdatabase.net/og-image/k760643-myelography-tray-wcuatico-myelograp-n-fda-510k.jpg K760643 - MYELOGRAPHY TRAY W/CUATICO MYELOGRAP N K760643 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1976. https://www.510kdatabase.net/k760588/ 1976-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k760588-improved-thayer-martin-medium-fda-510k.jpg K760588 - IMPROVED THAYER MARTIN MEDIUM K760588 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1976. https://www.510kdatabase.net/k760589/ 1976-10-07 monthly 0.5 https://www.510kdatabase.net/og-image/k760589-vca-inhibitor-fda-510k.jpg K760589 - VCA INHIBITOR K760589 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1976. https://www.510kdatabase.net/k760721/ 1976-10-06 monthly 0.5 https://www.510kdatabase.net/og-image/k760721-medical-oscilloscope-memory-scope-fda-510k.jpg K760721 - MEDICAL OSCILLOSCOPE MEMORY SCOPE K760721 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Laboratories. Cleared Oct 1976. https://www.510kdatabase.net/k760349/ 1976-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k760349-bilirubin-ref-sigma-stock-no-605-10-fda-510k.jpg K760349 - BILIRUBIN REF., SIGMA STOCK NO. 605-10 K760349 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Oct 1976. https://www.510kdatabase.net/k760649/ 1976-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k760649-total-spinal-correction-fda-510k.jpg K760649 - TOTAL SPINAL CORRECTION K760649 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Depuy, Inc.. Cleared Oct 1976. https://www.510kdatabase.net/k760688/ 1976-10-05 monthly 0.5 https://www.510kdatabase.net/og-image/k760688-ctn-ii-scanner-system-fda-510k.jpg K760688 - CT/N-II SCANNER SYSTEM K760688 is a FDA 510(k) cleared radiology medical device. Manufacturer: General Electric Co.. Cleared Oct 1976. https://www.510kdatabase.net/k760583/ 1976-10-03 monthly 0.5 https://www.510kdatabase.net/og-image/k760583-disposableborosilicate-culture-tubes-fda-510k.jpg K760583 - DISPOSABLE/BOROSILICATE CULTURE TUBES K760583 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Oct 1976. https://www.510kdatabase.net/k760602/ 1976-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k760602-sorvall-embedding-medium-fda-510k.jpg K760602 - SORVALL EMBEDDING MEDIUM K760602 is a FDA 510(k) cleared pathology medical device. Manufacturer: E.I. Dupont DE Nemours & Co., Inc.. Cleared Sep 1976. https://www.510kdatabase.net/k760611/ 1976-09-21 monthly 0.5 https://www.510kdatabase.net/og-image/k760611-3m-brand-anesthesia-filter3110-fda-510k.jpg K760611 - 3M BRAND ANESTHESIA FILTER,#3110 K760611 is a FDA 510(k) cleared general hospital medical device. Manufacturer: 3M Company. Cleared Sep 1976. https://www.510kdatabase.net/k760593/ 1976-09-16 monthly 0.5 https://www.510kdatabase.net/og-image/k760593-portable-cardiac-monitor-abby-fda-510k.jpg K760593 - PORTABLE CARDIAC MONITOR, ABBY K760593 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Abbott Laboratories. Cleared Sep 1976. https://www.510kdatabase.net/k760481/ 1976-09-15 monthly 0.5 https://www.510kdatabase.net/og-image/k760481-filter-particulate-arresting-fda-510k.jpg K760481 - FILTER, PARTICULATE ARRESTING K760481 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Sep 1976. https://www.510kdatabase.net/k760559/ 1976-09-10 monthly 0.5 https://www.510kdatabase.net/og-image/k760559-patient-monitoring-system-fda-510k.jpg K760559 - PATIENT MONITORING SYSTEM K760559 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: General Electric Co.. Cleared Sep 1976. https://www.510kdatabase.net/k760539/ 1976-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k760539-recorder-78640a-fda-510k.jpg K760539 - RECORDER (#78640A) K760539 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Sep 1976. https://www.510kdatabase.net/k760542/ 1976-09-09 monthly 0.5 https://www.510kdatabase.net/og-image/k760542-electrocardiograph-1505a-fda-510k.jpg K760542 - ELECTROCARDIOGRAPH (#1505A) K760542 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Sep 1976. https://www.510kdatabase.net/k760281/ 1976-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k760281-cup-holdercup-wheelchair-fda-510k.jpg K760281 - CUP HOLDER/CUP, WHEELCHAIR K760281 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Sep 1976. https://www.510kdatabase.net/k760282/ 1976-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k760282-cup-holdercupbk-1140-fda-510k.jpg K760282 - CUP HOLDER/CUP,BK-1140 K760282 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Sep 1976. https://www.510kdatabase.net/k760283/ 1976-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k760283-glass-sip-n-straw-with-lid-1143-fda-510k.jpg K760283 - GLASS, SIP N' STRAW WITH LID, 1143 K760283 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Sep 1976. https://www.510kdatabase.net/k760284/ 1976-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k760284-glass-nosey-cutout-bk-1146-fda-510k.jpg K760284 - GLASS, NOSEY CUTOUT, BK-1146 K760284 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Sep 1976. https://www.510kdatabase.net/k760285/ 1976-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k760285-cone-hand-bk-1501-fda-510k.jpg K760285 - CONE, HAND, BK-1501 K760285 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Sep 1976. https://www.510kdatabase.net/k760286/ 1976-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k760286-spoon-soft-food-feeder-bk-1473-fda-510k.jpg K760286 - SPOON, SOFT FOOD FEEDER, BK-1473 K760286 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Sep 1976. https://www.510kdatabase.net/k760287/ 1976-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k760287-button-aid-wpocket-clip-bk-2011-fda-510k.jpg K760287 - BUTTON AID W/POCKET CLIP, BK-2011 K760287 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Sep 1976. https://www.510kdatabase.net/k760288/ 1976-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k760288-viewer-reclining-bk-4089-fda-510k.jpg K760288 - VIEWER, RECLINING, BK-4089 K760288 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Sep 1976. https://www.510kdatabase.net/k760289/ 1976-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k760289-brush-disposa-a-handle-refill-pkg-fda-510k.jpg K760289 - BRUSH, DISPOSA-A (HANDLE, REFILL PKG) K760289 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Sep 1976. https://www.510kdatabase.net/k760290/ 1976-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k760290-cane-or-crutch-parker-34-78-l-fda-510k.jpg K760290 - CANE OR CRUTCH PARKER (3/4, 7/8, L) K760290 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Sep 1976. https://www.510kdatabase.net/k760291/ 1976-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k760291-holder-pencil-crayon-with-stand-fda-510k.jpg K760291 - HOLDER, PENCIL & CRAYON, WITH STAND K760291 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Sep 1976. https://www.510kdatabase.net/k760292/ 1976-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k760292-desk-beanbag-shuffle-bk-6059-fda-510k.jpg K760292 - DESK, BEANBAG SHUFFLE, BK-6059 K760292 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Sep 1976. https://www.510kdatabase.net/k760293/ 1976-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k760293-mirror-extend-a-bk-6235-fda-510k.jpg K760293 - MIRROR, EXTEND-A-, BK-6235 K760293 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Sep 1976. https://www.510kdatabase.net/k760294/ 1976-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k760294-levers-door-knob-bk-6395-fda-510k.jpg K760294 - LEVERS, DOOR KNOB, BK-6395 K760294 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Sep 1976. https://www.510kdatabase.net/k760295/ 1976-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k760295-carpet-covers-for-footrests-bk-6467-fda-510k.jpg K760295 - CARPET COVERS FOR FOOTRESTS, BK-6467 K760295 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Sep 1976. https://www.510kdatabase.net/k760296/ 1976-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k760296-adjuster-wheelchair-width-bk-6470-fda-510k.jpg K760296 - ADJUSTER, WHEELCHAIR WIDTH, BK-6470 K760296 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Sep 1976. https://www.510kdatabase.net/k760297/ 1976-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k760297-carrier-folding-luggage-bk-6511-fda-510k.jpg K760297 - CARRIER, FOLDING LUGGAGE, BK-6511 K760297 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Sep 1976. https://www.510kdatabase.net/k760298/ 1976-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k760298-support-wrist-firm-wire-foam-fda-510k.jpg K760298 - SUPPORT, WRIST, FIRM WIRE-FOAM K760298 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Sep 1976. https://www.510kdatabase.net/k760299/ 1976-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k760299-strip-closed-cell-foam-bk-7171-fda-510k.jpg K760299 - STRIP, CLOSED CELL FOAM, BK-7171 K760299 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Sep 1976. https://www.510kdatabase.net/k760300/ 1976-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k760300-padding-temper-stick-foam-bk-7175-fda-510k.jpg K760300 - PADDING, TEMPER STICK FOAM, BK-7175 K760300 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Sep 1976. https://www.510kdatabase.net/k760301/ 1976-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k760301-goniometer-med-inter-stand-bk-7512-fda-510k.jpg K760301 - GONIOMETER, MED. INTER. STAND. BK-7512 K760301 is a FDA 510(k) cleared neurology medical device. Manufacturer: Fred Sammons, Inc.. Cleared Sep 1976. https://www.510kdatabase.net/k760302/ 1976-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k760302-goniometer-inter-stand-large-bk7514-fda-510k.jpg K760302 - GONIOMETER, INTER. STAND. LARGE, BK7514 K760302 is a FDA 510(k) cleared neurology medical device. Manufacturer: Fred Sammons, Inc.. Cleared Sep 1976. https://www.510kdatabase.net/k760303/ 1976-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k760303-fork-tuning-bk-7519-fda-510k.jpg K760303 - FORK, TUNING BK-7519 K760303 is a FDA 510(k) cleared neurology medical device. Manufacturer: Fred Sammons, Inc.. Cleared Sep 1976. https://www.510kdatabase.net/k760304/ 1976-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k760304-canopy-parachute-bk-8110-fda-510k.jpg K760304 - CANOPY, PARACHUTE, BK-8110 K760304 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Sep 1976. https://www.510kdatabase.net/k760305/ 1976-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k760305-balloons-bk-8112-8114-fda-510k.jpg K760305 - BALLOONS, BK-8112, 8114 K760305 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Sep 1976. https://www.510kdatabase.net/k760306/ 1976-09-08 monthly 0.5 https://www.510kdatabase.net/og-image/k760306-cards-giant-face-playing-bk-9419-fda-510k.jpg K760306 - CARDS, GIANT FACE PLAYING BK-9419 K760306 is a FDA 510(k) cleared physical medicine medical device. Manufacturer: Fred Sammons, Inc.. Cleared Sep 1976. https://www.510kdatabase.net/k760457/ 1976-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k760457-schaedler-selective-agar-cna-fda-510k.jpg K760457 - SCHAEDLER-SELECTIVE AGAR CNA K760457 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1976. https://www.510kdatabase.net/k760458/ 1976-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k760458-bottle-blood-culture-schaedler-fda-510k.jpg K760458 - BOTTLE, BLOOD CULTURE, SCHAEDLER K760458 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1976. https://www.510kdatabase.net/k760459/ 1976-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k760459-mueller-hinton-agar-whemoglobin-fda-510k.jpg K760459 - MUELLER HINTON AGAR W/HEMOGLOBIN K760459 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1976. https://www.510kdatabase.net/k760460/ 1976-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k760460-schaedler-selective-agar-kv-fda-510k.jpg K760460 - SCHAEDLER SELECTIVE AGAR-KV K760460 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Sep 1976. https://www.510kdatabase.net/k760483/ 1976-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k760483-blood-solution-administration-set-surg-fda-510k.jpg K760483 - BLOOD-SOLUTION ADMINISTRATION SET, SURG. K760483 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Sep 1976. https://www.510kdatabase.net/k760505/ 1976-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k760505-solution-administration-set-2c0631-fda-510k.jpg K760505 - SOLUTION ADMINISTRATION SET (#2C0631) K760505 is a FDA 510(k) cleared general hospital medical device. Manufacturer: Travenol Laboratories, S.A.. Cleared Sep 1976. https://www.510kdatabase.net/k760523/ 1976-09-03 monthly 0.5 https://www.510kdatabase.net/og-image/k760523-monitor-scope-fda-510k.jpg K760523 - MONITOR SCOPE K760523 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Sep 1976. https://www.510kdatabase.net/k760042/ 1976-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k760042-blood-tubing-sets-fda-510k.jpg K760042 - BLOOD TUBING SETS K760042 is a FDA 510(k) cleared gastroenterology & urology medical device. Manufacturer: Bd Becton Dickinson Vacutainer Systems Preanalytic. Cleared Aug 1976. https://www.510kdatabase.net/k760278/ 1976-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k760278-slide-lab-tek-covered-micro-fda-510k.jpg K760278 - SLIDE, LAB-TEK COVERED MICRO K760278 is a FDA 510(k) cleared microbiology medical device. Manufacturer: Miles Laboratories, Inc.. Cleared Aug 1976. https://www.510kdatabase.net/k760463/ 1976-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k760463-stress-system-single-channel-21125-fda-510k.jpg K760463 - STRESS SYSTEM, SINGLE-CHANNEL (#21125) K760463 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Aug 1976. https://www.510kdatabase.net/k760464/ 1976-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k760464-phonstress-system-21126a-fda-510k.jpg K760464 - PHON/STRESS SYSTEM (#21126A) K760464 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Aug 1976. https://www.510kdatabase.net/k760465/ 1976-08-30 monthly 0.5 https://www.510kdatabase.net/og-image/k760465-stress-system-3-channel-21127a-fda-510k.jpg K760465 - STRESS SYSTEM, 3-CHANNEL (#21127A) K760465 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Hewlett-Packard Co.. Cleared Aug 1976. https://www.510kdatabase.net/k760448/ 1976-08-27 monthly 0.5 https://www.510kdatabase.net/og-image/k760448-syringe-co2-driven-il-automatic-inject-fda-510k.jpg K760448 - SYRINGE, CO2 DRIVEN, IL AUTOMATIC INJECT K760448 is a FDA 510(k) cleared cardiovascular medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Aug 1976. https://www.510kdatabase.net/k760211/ 1976-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k760211-analyzer-glucoseureacreatinine-fda-510k.jpg K760211 - ANALYZER, GLUCOSE/UREA/CREATININE K760211 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Aug 1976. https://www.510kdatabase.net/k760232/ 1976-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k760232-printer-il-460-fda-510k.jpg K760232 - PRINTER, IL 460 K760232 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Aug 1976. https://www.510kdatabase.net/k760233/ 1976-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k760233-table-sample-il-461-fda-510k.jpg K760233 - TABLE, SAMPLE IL 461 K760233 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Instrumentation Laboratory CO. Cleared Aug 1976. https://www.510kdatabase.net/k760247/ 1976-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k760247-glucose-reagent-sys-sigma-proced-115-fda-510k.jpg K760247 - GLUCOSE REAGENT SYS, SIGMA PROCED. 115 K760247 is a FDA 510(k) cleared chemistry medical device. Manufacturer: Sigma Chemical Co.. Cleared Aug 1976. https://www.510kdatabase.net/k760454/ 1976-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k760454-gouffon-pin-adjustable-fda-510k.jpg K760454 - GOUFFON PIN, ADJUSTABLE K760454 is a FDA 510(k) cleared orthopedic medical device. Manufacturer: Howmedica Corp.. Cleared Aug 1976. https://www.510kdatabase.net/k760455/ 1976-08-26 monthly 0.5 https://www.510kdatabase.net/og-image/k760455-obstetrical-pack-vigilon-ob-pack-fda-510k.jpg K760455 - OBSTETRICAL PACK (VIGILON OB PACK) K760455 is a FDA 510(k) cleared obstetrics & gynecology medical device. Manufacturer: C.R. Bard, Inc.. Cleared Aug 1976.